1 00:00:10,140 --> 00:00:12,276 >> WE'RE HERE TO KICK OFF DAY 2 00:00:12,276 --> 00:00:13,444 THREE AND I THINK IT'S FITTING 3 00:00:13,444 --> 00:00:17,915 THE SESSION FOLLOWS THE LAST ONE 4 00:00:17,915 --> 00:00:19,650 WHERE THERE WAS TALK ABOUT THE 5 00:00:19,650 --> 00:00:19,950 BIOMARKERS. 6 00:00:19,950 --> 00:00:22,586 WE'RE GOING TO TALK ABOUT THE 7 00:00:22,586 --> 00:00:24,855 FLUID DIGITAL AND OCULAR ONES. 8 00:00:24,855 --> 00:00:26,890 TO GET US STARTED THOUGH I WANT 9 00:00:26,890 --> 00:00:34,732 TO START BY TALKING ABOUT THE 10 00:00:34,732 --> 00:00:37,434 ARGENTINE ANT WHO I THINK OF AS 11 00:00:37,434 --> 00:00:38,702 THE ULTIMATE TEAM PLAYER BECAUSE 12 00:00:38,702 --> 00:00:45,142 IF YOU TAKE IT FROM ITS COLONY 13 00:00:45,142 --> 00:00:46,977 AND WANDERS INTO ANOTHER COLONY 14 00:00:46,977 --> 00:00:48,879 OF DIFFERENT ANTS IT WILL PICK 15 00:00:48,879 --> 00:00:50,714 UP WHAT THE TEAM IS DOING AND 16 00:00:50,714 --> 00:00:55,185 CONTRIBUTE IN ANY WAY THAT IT 17 00:00:55,185 --> 00:00:55,352 CAN. 18 00:00:55,352 --> 00:00:58,789 IT TURNS OUT IF YOU TAKE ANY OF 19 00:00:58,789 --> 00:01:02,092 THESE ARGENTINE ANTS AND HAVE 20 00:01:02,092 --> 00:01:03,794 THEM MOVE TO ANY PART OF THE 21 00:01:03,794 --> 00:01:06,463 WORLD, THEY WILL CONTRIBUTE TO 22 00:01:06,463 --> 00:01:08,365 THAT TEAM WHICH THEN CONTRIBUTES 23 00:01:08,365 --> 00:01:11,168 TO A MUCH LARGER ECO SYSTEM THAT 24 00:01:11,168 --> 00:01:13,404 IS CUSTOMIZED TO DIFFERENT 25 00:01:13,404 --> 00:01:13,804 REGIONS. 26 00:01:13,804 --> 00:01:16,340 AND I REALLY THINK THIS SETS A 27 00:01:16,340 --> 00:01:18,742 GREAT CONTEXT FOR WHAT WE'RE 28 00:01:18,742 --> 00:01:21,845 TRYING TO DO AS WELL. 29 00:01:21,845 --> 00:01:23,914 SO LET'S START WITH FLUID 30 00:01:23,914 --> 00:01:24,214 BIOMARKERS. 31 00:01:24,214 --> 00:01:26,950 WE'LL HEAR TODAY ABOUT ALL THE 32 00:01:26,950 --> 00:01:28,185 DIFFERENT WAYS IN WHICH FLUID 33 00:01:28,185 --> 00:01:31,121 BIOMARKERS ARE NOW STARTING TO 34 00:01:31,121 --> 00:01:33,023 REALLY CHANGE THE LANDSCAPE OF 35 00:01:33,023 --> 00:01:35,859 HOW WE DO OUR RESEARCH. 36 00:01:35,859 --> 00:01:37,594 MORE AND MORE, WE'RE TALKING 37 00:01:37,594 --> 00:01:39,029 ABOUT NOW DIGITAL BIOMARKERS. 38 00:01:39,029 --> 00:01:43,333 I WAS REALLY EXCITED EVERY DAY 39 00:01:43,333 --> 00:01:45,269 SOMEONE MENTIONED DIGITAL. 40 00:01:45,269 --> 00:01:46,837 THIS IS NO LONGER SOMETHING IN 41 00:01:46,837 --> 00:01:52,509 THE BACKGROUND BUT MOVING TO THE 42 00:01:52,509 --> 00:01:53,210 FOREGROUND. 43 00:01:53,210 --> 00:01:56,413 AND THEN THE OTHER YOUR PEOPLE 44 00:01:56,413 --> 00:01:57,681 ARE TALKING A LOT ABOUT ARE 45 00:01:57,681 --> 00:01:59,450 THESE OCULAR BIOMARKERS WE'LL 46 00:01:59,450 --> 00:02:01,618 HEAR ABOUT AS WELL. 47 00:02:01,618 --> 00:02:02,920 I THINK IN COMBINATION WHAT WE 48 00:02:02,920 --> 00:02:06,490 NEED TO THINK ABOUT IS HOW ALL 49 00:02:06,490 --> 00:02:08,792 THESE DIFFERENT TYPES OF 50 00:02:08,792 --> 00:02:10,194 BIOMARKERS ARE GOING TO COME 51 00:02:10,194 --> 00:02:13,797 TOGETHER ALL ACROSS THE WORLD IN 52 00:02:13,797 --> 00:02:15,933 UNIQUE COMBINATIONS IN ORDER TO 53 00:02:15,933 --> 00:02:20,003 ACTUALLY FACILITATE REALLY NEW 54 00:02:20,003 --> 00:02:22,306 SCIENCE IN DIFFERENT DIRECTIONS 55 00:02:22,306 --> 00:02:24,608 AND WAYS WE NEVER THOUGHT OF 56 00:02:24,608 --> 00:02:24,942 BEFORE. 57 00:02:24,942 --> 00:02:28,378 SO WITH THIS WE'RE GOING TO GET 58 00:02:28,378 --> 00:02:29,580 STARTED WITH OUR PANEL. 59 00:02:29,580 --> 00:02:32,983 I AM GOING TO UP FRONT TELL YOU 60 00:02:32,983 --> 00:02:35,385 THAT DONNA AND I ARE GOING TO BE 61 00:02:35,385 --> 00:02:37,354 THE TIME NAZIS AND WE'RE GOING 62 00:02:37,354 --> 00:02:39,690 TO KEEP EVERYBODY ON TIME. 63 00:02:39,690 --> 00:02:44,528 SO WITH THAT, I'D LIKE OUR FIRST 64 00:02:44,528 --> 00:02:46,730 SPEAKER, DONNA WILL GO AHEAD AND 65 00:02:46,730 --> 00:02:50,701 INTRODUCE EACH ONE. 66 00:02:50,701 --> 00:02:52,936 THANK YOU. 67 00:02:52,936 --> 00:02:54,471 >> ABOUT MORNING, EVERYBODY. 68 00:02:54,471 --> 00:03:02,713 OUR FIRST SPEAKER OF THE DAY IS 69 00:03:02,713 --> 00:03:04,715 SUDHIR SRIVASTAVA FROM THE 70 00:03:04,715 --> 00:03:06,149 NATIONAL CANCER INSTITUTE. 71 00:03:06,149 --> 00:03:07,518 >> GOOD MORNING. 72 00:03:07,518 --> 00:03:12,890 CAN YOU LOAD MY SLIDES, PLEASE. 73 00:03:12,890 --> 00:03:15,425 I JUST WANT IT SAY HOW FAST 74 00:03:15,425 --> 00:03:18,395 NATING THE OPENING REMARK -- 75 00:03:18,395 --> 00:03:21,665 FASCINATING TE OPENING REMOOSHG 76 00:03:21,665 --> 00:03:24,601 AND IN WE SAY IT TAKES A VILLAGE 77 00:03:24,601 --> 00:03:29,907 AND THIS TAKES A GLOBAL EFFORT. 78 00:03:29,907 --> 00:03:38,749 I CANNOT SEE MY SLIDES. 79 00:03:38,749 --> 00:03:45,222 THE TOPIC IS FROM FIVE YEARS AT 80 00:03:45,222 --> 00:03:45,689 NCI. 81 00:03:45,689 --> 00:03:48,458 IT TAKES A VILLAGE. 82 00:03:48,458 --> 00:03:53,797 WE JUST HAD A FASCINATING 83 00:03:53,797 --> 00:03:58,735 INTRODUCTION AND I DON'T THINK I 84 00:03:58,735 --> 00:04:02,706 CAN CAPTURE THOSE BUT I WANT TO 85 00:04:02,706 --> 00:04:08,445 GIVE A SNIPPET. 86 00:04:08,445 --> 00:04:15,686 SO AS YOU KNOW OVER THE YEARS WE 87 00:04:15,686 --> 00:04:21,425 HAVE A MADE PROGRESS AND 88 00:04:21,425 --> 00:04:26,763 THEREFORE WE HAVE BEEN TRYING TO 89 00:04:26,763 --> 00:04:37,040 PROTECT CANCER. 90 00:04:38,175 --> 00:04:42,212 IN OUR EFFORTS FOR BIOMARKERS 91 00:04:42,212 --> 00:04:44,214 AND TO JUSTIFY THE BIOMARKERS IF 92 00:04:44,214 --> 00:04:46,049 YOU DETECT CANCER AT THE EARLY 93 00:04:46,049 --> 00:04:49,152 STABLE THE FIVE-YEAR SURVIVAL IS 94 00:04:49,152 --> 00:04:52,823 MUCH BETTER FOR EPITHELIAL 95 00:04:52,823 --> 00:04:55,225 TUMORS AND PROSTATE AND LUNG 96 00:04:55,225 --> 00:04:56,860 CANCER AND SO ON. 97 00:04:56,860 --> 00:05:01,198 THIS IS ALL ABOUT THE 98 00:05:01,198 --> 00:05:01,498 BIOMARKERS. 99 00:05:01,498 --> 00:05:09,673 THEY HAVE DEVELOPED A NUMBER OF 100 00:05:09,673 --> 00:05:14,711 BIOMARKERS AND THE RADIOMICS AND 101 00:05:14,711 --> 00:05:22,719 THERE'S DISTAL BIOMARKERS AND IN 102 00:05:22,719 --> 00:05:25,455 IMAGING AND ALWAYS KIND IMAGING 103 00:05:25,455 --> 00:05:31,662 WITH BIOMARKERS AND WHAT WE CALL 104 00:05:31,662 --> 00:05:34,031 DIAGNOSTIC ODYSSEY BECAUSE WE 105 00:05:34,031 --> 00:05:44,574 NEED TO CONFORM AND YOU CAN SEE 106 00:05:45,709 --> 00:05:50,714 VERY IMPRESSIVE GAIN IN TERMS OF 107 00:05:50,714 --> 00:05:52,215 FIVE-YEAR SURVIVAL DATE. 108 00:05:52,215 --> 00:05:58,255 SO OVER THE YEARS WE HAVE BEEN 109 00:05:58,255 --> 00:06:08,832 DEVELOPING BIOMARKERS AND 110 00:06:14,671 --> 00:06:17,174 THERE'S SPECIFICITY BUT THERE'S 111 00:06:17,174 --> 00:06:20,844 FEW IN THE PROCESS AND ON THE 112 00:06:20,844 --> 00:06:26,383 RIGHT HAND I SHOW THERE'S MODEST 113 00:06:26,383 --> 00:06:30,253 FIVE BIOMARKERS PER YEAR FOR 114 00:06:30,253 --> 00:06:32,956 EARLY DETECTION AND DIAGNOSIS. 115 00:06:32,956 --> 00:06:35,058 EVEN THE SLIDE IS OLDER FROM 116 00:06:35,058 --> 00:06:42,899 2013 BUT THE FINDINGS ARE STILL 117 00:06:42,899 --> 00:06:50,707 VALID. 118 00:06:50,707 --> 00:06:54,678 A 119 00:06:54,678 --> 00:07:00,150 AND THIS IS VERY CHALLENGING FOR 120 00:07:00,150 --> 00:07:05,922 US AND I HAVE NOT SERVED US VERY 121 00:07:05,922 --> 00:07:07,724 WELL THE REASON MOST STUDIES 122 00:07:07,724 --> 00:07:09,292 HAVE BEEN DEVELOPED OVER THE 123 00:07:09,292 --> 00:07:19,770 YEARS AND FOR STUDY DESIGN 124 00:07:21,371 --> 00:07:23,073 THERE'S INCOMPLETE PROTOCOL AND 125 00:07:23,073 --> 00:07:23,573 REPORTING. 126 00:07:23,573 --> 00:07:27,677 IN A BASIC SCIENCE SETTING 127 00:07:27,677 --> 00:07:29,679 PROTOCOL IS LIKE HAVING A PAPER 128 00:07:29,679 --> 00:07:30,280 DESCRIBING DESIGN. 129 00:07:30,280 --> 00:07:32,983 THAT'S NOT THE CASE IN THE 130 00:07:32,983 --> 00:07:39,189 CLINICAL SETTING WHEN YOU HAVE 131 00:07:39,189 --> 00:07:43,627 BIOMARKERS. 132 00:07:43,627 --> 00:07:45,929 ALSO SOMETIMES BIOMARKERS ARE 133 00:07:45,929 --> 00:07:48,799 PUBLISHED BY INVESTIGATORS IN 134 00:07:48,799 --> 00:07:52,536 WHAT WE CALL SELECTIVE REPORTING 135 00:07:52,536 --> 00:08:03,113 AND NOT REPORTING NEGATIVE SIDE 136 00:08:03,113 --> 00:08:06,316 AND THERE'S A CHALLENGE IN THE 137 00:08:06,316 --> 00:08:08,051 BIOMARKER FIELD BECAUSE MOST THE 138 00:08:08,051 --> 00:08:10,654 BIOMARKERS ARE DEVELOPED IN A 139 00:08:10,654 --> 00:08:17,394 SINGLE LAB AND THEN VALIDATED. 140 00:08:17,394 --> 00:08:21,264 HOWEVER, AS YOU KNOW ONE CANNOT 141 00:08:21,264 --> 00:08:22,265 BE PROSECUTOR AND JUDGE AT THE 142 00:08:22,265 --> 00:08:24,668 SAME TIME. 143 00:08:24,668 --> 00:08:26,369 IF YOU'RE A DISCOVERER OF THE 144 00:08:26,369 --> 00:08:30,574 BIOMARKER YOU NEED TO HAND IT 145 00:08:30,574 --> 00:08:33,543 OVER TO A LAB FOR VERIFICATION 146 00:08:33,543 --> 00:08:36,246 AND THAT'S THE BASIC CANNON OF 147 00:08:36,246 --> 00:08:45,222 THE NETWORK AT NCI. 148 00:08:45,222 --> 00:08:47,023 AND IN TERMS OF BIOMARKER 149 00:08:47,023 --> 00:08:48,792 DISCOVERY YOU NEED TO 150 00:08:48,792 --> 00:08:51,094 COLLABORATE WITH THE PEOPLE 151 00:08:51,094 --> 00:08:53,129 EXPERT IN DESIGNING TRIALS OR 152 00:08:53,129 --> 00:08:58,001 VALIDATING THE BIOMARKERS. 153 00:08:58,001 --> 00:09:03,473 THEREFORE WE NEED TO GET TO THE 154 00:09:03,473 --> 00:09:03,673 SPACE. 155 00:09:03,673 --> 00:09:06,977 THIS HAS BEEN THE BASIC TENET 156 00:09:06,977 --> 00:09:12,148 BEHIND THE EDI AND WE NEED TO 157 00:09:12,148 --> 00:09:14,517 HAVE TO BE IN THE BUSINESS OF 158 00:09:14,517 --> 00:09:18,722 DISCOVERY AND NEED EXPERTS TO 159 00:09:18,722 --> 00:09:21,591 VALIDATE THE ASSAY. 160 00:09:21,591 --> 00:09:22,192 BIOMARKER DISCOVERY WITHOUT 161 00:09:22,192 --> 00:09:23,927 CONSIDERING THE CONTENT IS NOT 162 00:09:23,927 --> 00:09:26,529 HELPFUL BECAUSE WE NEED TO THINK 163 00:09:26,529 --> 00:09:30,467 OF THE PERSON IN MIND BEFORE WE 164 00:09:30,467 --> 00:09:32,869 EMBARK ON THE BIOMARKER. 165 00:09:32,869 --> 00:09:33,470 STATISTICIANS PLAY IMPORTANT 166 00:09:33,470 --> 00:09:38,608 ROLES AND WE SEE APPLICATION IN 167 00:09:38,608 --> 00:09:39,442 THE BIOMARKERS. 168 00:09:39,442 --> 00:09:41,244 WE FIND THE DETAILS ABOUT STUDY 169 00:09:41,244 --> 00:09:49,686 DESIGN ARE MISSING. 170 00:09:49,686 --> 00:09:52,322 THIS IS BECAUSE YOU NEED TO 171 00:09:52,322 --> 00:09:56,826 MANAGE DATA AND PROVIDER QUALITY 172 00:09:56,826 --> 00:09:59,362 AND IN A NUTSHELL EDRN. 173 00:09:59,362 --> 00:10:03,833 THEY'RE OPTIMIZED IN THE 174 00:10:03,833 --> 00:10:06,703 FOLLOWING STRUCTURE. 175 00:10:06,703 --> 00:10:09,673 THERE'S A BIOMARKER 176 00:10:09,673 --> 00:10:11,908 DEVELOPMENTAL LAB AND THE 177 00:10:11,908 --> 00:10:14,711 DISCOVERY IS MADE AND GOES TO 178 00:10:14,711 --> 00:10:16,880 THE REFERENCE LAB AND THEN 179 00:10:16,880 --> 00:10:19,516 DISCOVERY LAB AND THE VALIDATION 180 00:10:19,516 --> 00:10:22,018 CENTER WHERE THE STUDY DESIGN IS 181 00:10:22,018 --> 00:10:27,057 CONDUCTED TO VALIDATE THE 182 00:10:27,057 --> 00:10:27,357 BIOMARKERS. 183 00:10:27,357 --> 00:10:29,659 IF YOU FAIL IT'S BACK TO THE 184 00:10:29,659 --> 00:10:32,062 DRAWING BOARD TO LOOK TO THE 185 00:10:32,062 --> 00:10:32,462 REGION. 186 00:10:32,462 --> 00:10:35,598 EVEN THE FAILURE IN THIS CASE 187 00:10:35,598 --> 00:10:36,967 ARE HELPFUL FOR WHAT WENT WRONG 188 00:10:36,967 --> 00:10:42,706 AND HOW IT CAN BE BETTER. 189 00:10:42,706 --> 00:10:44,808 SO THE OBJECTIVE ARE TO SUPPORT 190 00:10:44,808 --> 00:10:48,211 RESEARCH FOR THE DEVELOPMENT AND 191 00:10:48,211 --> 00:10:51,448 VALIDATION OF BIOMARKERS 192 00:10:51,448 --> 00:10:53,049 PROGRESSION, COOPERATION BETWEEN 193 00:10:53,049 --> 00:10:54,684 ACADEMIC AND INDUSTRIAL LEADERS. 194 00:10:54,684 --> 00:10:59,155 ESTABLISH AND APPLY STANDARDIZED 195 00:10:59,155 --> 00:11:02,492 BIOMARKERS CRITERIA AND MOST 196 00:11:02,492 --> 00:11:05,996 IMPORTANTLY WHAT TO FACILITATE 197 00:11:05,996 --> 00:11:08,932 THE PROCESS TO BRING BIOMARKERS 198 00:11:08,932 --> 00:11:10,900 INTO CLINICAL USE. 199 00:11:10,900 --> 00:11:12,869 AND THE PROGRAM ON BIOMARKER 200 00:11:12,869 --> 00:11:14,537 DISCOVERY AND EARLY VALIDATION 201 00:11:14,537 --> 00:11:20,443 FOR EARLY DETECTION OF CANCER. 202 00:11:20,443 --> 00:11:23,446 IT HAS DEVELOPED MORE THAN EIGHT 203 00:11:23,446 --> 00:11:27,417 BIOMARKERS TO BE APPROVED AND 22 204 00:11:27,417 --> 00:11:35,625 THAT ARE WAITING TO BE APPROVED. 205 00:11:35,625 --> 00:11:43,600 SO, THEY DON'T FOLLOW THE 206 00:11:43,600 --> 00:11:43,967 BIOMARKER SIGN. 207 00:11:43,967 --> 00:11:46,669 WE DEVELOPED GUIDELINE FOR 208 00:11:46,669 --> 00:11:48,405 DISCOVERY AND DEVELOPMENT. 209 00:11:48,405 --> 00:11:54,210 THIS IS ONE OF THE MOST CITED 210 00:11:54,210 --> 00:11:58,715 PAPERS IF YOU'RE LOOKING FOR 211 00:11:58,715 --> 00:11:59,382 THIS. 212 00:11:59,382 --> 00:12:01,551 THERE'S BIOMARKER VALIDATION 213 00:12:01,551 --> 00:12:04,587 INCLUDING CRITERIA PHASE 1, 2, 214 00:12:04,587 --> 00:12:09,692 3, 4 AND 5 AND BASED ON 215 00:12:09,692 --> 00:12:10,693 STATISTICAL RIGOR. 216 00:12:10,693 --> 00:12:12,729 THE PHASE 1 IS PROGRAM OF 217 00:12:12,729 --> 00:12:14,531 PROMISING DIRECTION IDENTIFIED 218 00:12:14,531 --> 00:12:18,701 AND THEN PHASE 2, THE CLINICAL 219 00:12:18,701 --> 00:12:22,906 ASSAY DETECTS THE ESTABLISHED 220 00:12:22,906 --> 00:12:24,774 DISEASE AND THEN PHASE 3 IS 221 00:12:24,774 --> 00:12:26,709 SCREEN POSITIVE AND MOST ARE IN 222 00:12:26,709 --> 00:12:30,046 PHASE 1 WAS THEY CANNOT MAKE IT 223 00:12:30,046 --> 00:12:31,648 TO PHASE 2. 224 00:12:31,648 --> 00:12:34,217 NEITHER DEVELOPMENT OF THE 225 00:12:34,217 --> 00:12:35,118 CLINICAL ASSAY OR -- 226 00:12:35,118 --> 00:12:37,320 >> YOU NEED TO WRAP UP PRETTY 227 00:12:37,320 --> 00:12:42,625 SOON YOU HAVE LESS THAN A 228 00:12:42,625 --> 00:12:43,026 MINUTE. 229 00:12:43,026 --> 00:12:47,897 >> OKAY. 230 00:12:47,897 --> 00:12:48,598 NEXT, PLEASE. 231 00:12:48,598 --> 00:12:52,202 WE DEVELOPED WHAT IS USED TO 232 00:12:52,202 --> 00:12:54,571 TREAT OUR BIOMARKERS FROM GOOD 233 00:12:54,571 --> 00:12:58,741 TO BAD BIOMARKERS AND THESE ARE 234 00:12:58,741 --> 00:13:06,015 STORED AT NCI FREDERICK AND THEY 235 00:13:06,015 --> 00:13:11,721 CAN LOOK AT THE CANCER TARGET. 236 00:13:11,721 --> 00:13:15,892 OUR SYSTEM ALLOWS NOVEL 237 00:13:15,892 --> 00:13:16,559 MECHANISM. 238 00:13:16,559 --> 00:13:22,332 I JUST WANTED TO SHOW YOU THE 239 00:13:22,332 --> 00:13:29,239 LIST FACILITATED. 240 00:13:29,239 --> 00:13:31,441 >> WE NEED TO WRAP UP NOW TO GET 241 00:13:31,441 --> 00:13:33,676 TO THE NEXT SPEAKER. 242 00:13:33,676 --> 00:13:34,611 >> I'LL STOP HERE. 243 00:13:34,611 --> 00:13:44,287 >> THANK YOU SO MUCH FOR THAT. 244 00:13:44,287 --> 00:13:46,723 OUR NEXT SPEAKER IS DR. MICHAEL 245 00:13:46,723 --> 00:13:47,357 SNYDER FROM STANFORD UNIVERSITY. 246 00:13:47,357 --> 00:13:50,793 MICHAEL. 247 00:13:50,793 --> 00:13:52,228 >> OKAY. 248 00:13:52,228 --> 00:13:54,097 IT'S A GREAT PLEASURE TO BE 249 00:13:54,097 --> 00:13:54,697 HERE. 250 00:13:54,697 --> 00:13:57,167 IF WE CAN GO BACK TO THE FIRST 251 00:13:57,167 --> 00:13:58,134 SLIDE THAT WOULD BE GREAT. 252 00:13:58,134 --> 00:14:00,637 THESE ARE THE PEOPLE THAT DID 253 00:14:00,637 --> 00:14:02,305 THE WORK. 254 00:14:02,305 --> 00:14:06,309 SO, OUR LAB GENERATES DEEP DATA 255 00:14:06,309 --> 00:14:08,278 WITH THE IDEA OF TRYING PROFILE 256 00:14:08,278 --> 00:14:10,346 THEM BASED ON THE PREMISE WE 257 00:14:10,346 --> 00:14:12,148 THINK WE PRACTICE SICK CARE 258 00:14:12,148 --> 00:14:13,716 THESE DAYS RATHER THAN HEALTH 259 00:14:13,716 --> 00:14:13,917 CARE. 260 00:14:13,917 --> 00:14:15,418 WHAT OUR LAB HAS BEEN TRYING TO 261 00:14:15,418 --> 00:14:17,287 DO IS CHANGE THE PARADIGM ON 262 00:14:17,287 --> 00:14:19,022 THIS. 263 00:14:19,022 --> 00:14:20,290 SPECIFICALLY WHEN WE PRACTICE 264 00:14:20,290 --> 00:14:22,358 HEALTH CARE YOU'LL TYPICALLY GET 265 00:14:22,358 --> 00:14:24,594 IN A CAR, ALWAYS AT A TIME AND 266 00:14:24,594 --> 00:14:27,664 TRAVEL TO A PHYSICIANS OFFICE 267 00:14:27,664 --> 00:14:29,566 WHERE THEY'LL STICK A NEEDLE AND 268 00:14:29,566 --> 00:14:32,168 TAKE LOTS OF BLOOD AND THEY ARE 269 00:14:32,168 --> 00:14:35,004 DON'T MAKE VERY MANY 270 00:14:35,004 --> 00:14:38,174 MEASUREMENTS AND FROM THAT 271 00:14:38,174 --> 00:14:40,143 THEY'LL MAKE DECISIONS ABOUT 272 00:14:40,143 --> 00:14:41,678 YOUR HEALTH BASED ON POPULATION 273 00:14:41,678 --> 00:14:43,046 AGGREGATES SO THIS IS WHAT I 274 00:14:43,046 --> 00:14:45,148 WANT TO TALK ABOUT TODAY. 275 00:14:45,148 --> 00:14:50,353 A NUMBER OF YEARS AGO ROUGHLY 14 276 00:14:50,353 --> 00:14:52,722 AND A HALF WE SET UP CRYSTAL 277 00:14:52,722 --> 00:14:54,691 OMICS PROFILING. 278 00:14:54,691 --> 00:14:59,395 THE IDEA IS TAKE BLOOD, URINE 279 00:14:59,395 --> 00:15:04,667 AND STOOL AND SEQUENCE GENOME 280 00:15:04,667 --> 00:15:09,672 AND MEASURE TRANSCRIPTOME, 281 00:15:09,672 --> 00:15:11,674 PROTEOME AND OTHER THINGS AS 282 00:15:11,674 --> 00:15:14,644 WELL AND OUT OF THE PLASMA 283 00:15:14,644 --> 00:15:21,284 MEASURE CYTOKINES AND BIOMARKER 284 00:15:21,284 --> 00:15:21,884 AND WEARABLES. 285 00:15:21,884 --> 00:15:24,520 THE IDEA IS TO TAKE DEEP DATA ON 286 00:15:24,520 --> 00:15:27,056 PEOPLE AND THE OTHER ASPECT IS 287 00:15:27,056 --> 00:15:27,557 OVER TIME. 288 00:15:27,557 --> 00:15:28,891 ROUGHLY EVERY THREE MONTHS WHILE 289 00:15:28,891 --> 00:15:29,692 THEY'RE HEALTHY. 290 00:15:29,692 --> 00:15:32,662 SO WE'RE TAKING SAMPLES WHILE 291 00:15:32,662 --> 00:15:35,164 HEALTHY AND IN AN ADVERSE EVENT 292 00:15:35,164 --> 00:15:38,167 LIKE A VIRAL INFECTION WE'LL 293 00:15:38,167 --> 00:15:39,369 TAKE ADDITIONAL SAMPLES. 294 00:15:39,369 --> 00:15:40,737 WE'RE TRYING TO UNDERSTAND WHAT 295 00:15:40,737 --> 00:15:42,705 A HEALTHY PROFILE LOOK LIKE AND 296 00:15:42,705 --> 00:15:45,675 HOW DOES IT CHANGE OVER TIME, 297 00:15:45,675 --> 00:15:46,909 WHAT HAPPENS AT THE EARLIEST 298 00:15:46,909 --> 00:15:50,513 TIME OF ILLNESS AND CAN YOU USE 299 00:15:50,513 --> 00:15:54,317 GENOME SEQUENCING TO BETTER 300 00:15:54,317 --> 00:15:54,884 MANAGER HEALTH WHICH WAS 301 00:15:54,884 --> 00:15:56,552 CONTROVERSIAL WHEN WE LAUNCHED. 302 00:15:56,552 --> 00:15:58,588 WITH REGARD TO THE LAST POINT 303 00:15:58,588 --> 00:15:59,589 THE FIRST THREE AND A HALF YEARS 304 00:15:59,589 --> 00:16:02,058 OF PROFILING FROM A SMALL GROUP 305 00:16:02,058 --> 00:16:04,160 OF 109 PEOPLE NEARLY HALF 306 00:16:04,160 --> 00:16:06,496 LEARNED SOMETHING PRETTY 307 00:16:06,496 --> 00:16:09,832 IMPORTANT ABOUT THEIR HEALTH AND 308 00:16:09,832 --> 00:16:13,536 HEART ISSUES AND WE HAVE EARLY 309 00:16:13,536 --> 00:16:15,905 LYMPHOMA, TWO PRECANCERS ALL 310 00:16:15,905 --> 00:16:25,715 FOUND PRESYMPTOMATICALLY AND YOU 311 00:16:25,715 --> 00:16:28,951 CAN SEE WHAT'S GOING ON IN 312 00:16:28,951 --> 00:16:31,654 ADVANCE OF SYMPTOMS. 313 00:16:31,654 --> 00:16:34,090 EVERYTHING I'M TELLING YOU IS 314 00:16:34,090 --> 00:16:35,191 CONFLICTED HERE. 315 00:16:35,191 --> 00:16:36,726 AND THE OTHER THING YOU CAN GET 316 00:16:36,726 --> 00:16:39,228 AS YOU PROFILE DEEPLY YOU CAN 317 00:16:39,228 --> 00:16:41,064 SEE HOW THEY CHANGE OVER TIME WE 318 00:16:41,064 --> 00:16:43,833 INTERPRET AS AGING. 319 00:16:43,833 --> 00:16:45,401 FROM THE HEALTHY TIME POINTS YOU 320 00:16:45,401 --> 00:16:47,337 CAN SEE EVERYBODY'S AGING 321 00:16:47,337 --> 00:16:48,171 DIFFERENTLY. 322 00:16:48,171 --> 00:16:53,943 THE AMERICAN IN THE MIDDLE, 323 00:16:53,943 --> 00:16:55,845 PERSON 2 HAVE SIGNALLING PATHWAY 324 00:16:55,845 --> 00:16:57,680 THAT CHANGES AND THE ONE ON THE 325 00:16:57,680 --> 00:17:00,350 LEFT IS A TYPICAL AGER, THEIR 326 00:17:00,350 --> 00:17:02,418 IMMUNE SYSTEM, METABOLIC AND 327 00:17:02,418 --> 00:17:04,921 OTHER PATHWAYS SHIFT OVER TIME. 328 00:17:04,921 --> 00:17:07,056 WE THINK FROM AS FEW AS FIVE 329 00:17:07,056 --> 00:17:08,491 TIME POINTS OVER TWO YEARS WE 330 00:17:08,491 --> 00:17:12,395 CAN SEE HOW PEOPLE ARE AGING 331 00:17:12,395 --> 00:17:14,063 THOUGH YOU CAN DO IT MUCH 332 00:17:14,063 --> 00:17:16,065 RAPIDLY AS WELL AND CALL THESE 333 00:17:16,065 --> 00:17:19,235 AGING PATTERNS AGOTYPES. 334 00:17:19,235 --> 00:17:21,537 YOU SEE FOUR TYPES OF FOUR 335 00:17:21,537 --> 00:17:24,140 PEOPLE AND THEY'LL HAVE 336 00:17:24,140 --> 00:17:26,709 DIFFERENT AGEOTYPES AND THERE'S 337 00:17:26,709 --> 00:17:28,945 MARKERS YOU CAN ACT UPON. 338 00:17:28,945 --> 00:17:32,281 IF YOU LOOK AT THE GROUP AS A 339 00:17:32,281 --> 00:17:33,916 WHOLE YOU CAN SAY SOMETIMES 340 00:17:33,916 --> 00:17:36,085 DURING THESE YEARS WHERE THERE 341 00:17:36,085 --> 00:17:37,053 MIGHT BE MORE CHANGES THAN 342 00:17:37,053 --> 00:17:38,721 OTHERS AND RECENTLY PUBLISHED 343 00:17:38,721 --> 00:17:41,190 AND AGING IS NOT MANY OR YOU 344 00:17:41,190 --> 00:17:46,396 DON'T JUST GRADUALLY GET OLDER. 345 00:17:46,396 --> 00:17:49,632 KNOW YOUR IMMUNE CHANGES AND YOU 346 00:17:49,632 --> 00:17:51,134 GET VACCINATED AND THERE'S A 347 00:17:51,134 --> 00:17:53,202 BURST THERE WE SEE OTHER CHANGES 348 00:17:53,202 --> 00:17:56,372 AS WELL BECAUSE WE'RE PROFILING 349 00:17:56,372 --> 00:17:57,306 SO DEEPLY. 350 00:17:57,306 --> 00:17:59,409 IT SHOULD SAY 135,000 MARKERS. 351 00:17:59,409 --> 00:18:02,145 THERE'S ALSO A BIG SHIFT AROUND 352 00:18:02,145 --> 00:18:03,546 THE 40s. 353 00:18:03,546 --> 00:18:05,548 YOU'RE EITHER ON WERE WAY TO 354 00:18:05,548 --> 00:18:08,618 THIS IN YOUR 40s OR 50s AND 60s 355 00:18:08,618 --> 00:18:10,820 AND THERE'S MARKERS ASSOCIATED 356 00:18:10,820 --> 00:18:11,687 ONCE AGAIN. 357 00:18:11,687 --> 00:18:14,090 YOU CAN TAKE ACTION ON THE 358 00:18:14,090 --> 00:18:14,390 INFORMATION. 359 00:18:14,390 --> 00:18:15,725 THE OTHER THING WE'RE PUSHING 360 00:18:15,725 --> 00:18:18,694 HARD IS THE IDEA ABOUT DOING 361 00:18:18,694 --> 00:18:19,962 REMOTE HEALTH MONITORING WHICH I 362 00:18:19,962 --> 00:18:22,498 THINK IS RELEVANT FOR RUNNING 363 00:18:22,498 --> 00:18:23,900 STUDIES IN THE MENTAL HEALTH 364 00:18:23,900 --> 00:18:25,101 SPACE BECAUSE MOST PEOPLE DON'T 365 00:18:25,101 --> 00:18:26,702 WANT TO COME IN TO GET MEASURED 366 00:18:26,702 --> 00:18:28,971 AND MEASUREMENTS IN A CLINIC ARE 367 00:18:28,971 --> 00:18:30,673 NOT REFLECTING WHAT'S GOING ON 368 00:18:30,673 --> 00:18:32,074 AT HOME. 369 00:18:32,074 --> 00:18:34,243 WE'VE BEEN PUSHING TWO FRONTS. 370 00:18:34,243 --> 00:18:36,579 ONE IS THE WEARABLES. 371 00:18:36,579 --> 00:18:41,350 ANOTHER IS CALLED HOME MICRO 372 00:18:41,350 --> 00:18:43,653 SAMPLING AND WE DO DEEP 373 00:18:43,653 --> 00:18:48,124 MEASUREMENTS THERE'S DEVICES OUT 374 00:18:48,124 --> 00:18:50,693 THERE IN THE FORM OF SMART 375 00:18:50,693 --> 00:18:51,060 WATCHES. 376 00:18:51,060 --> 00:18:54,564 I MYSELF USUALLY HAVE FOUR 377 00:18:54,564 --> 00:19:00,770 WATCHES, ONE BROKE AND HEARING 378 00:19:00,770 --> 00:19:08,411 AIDS ARE USEFUL FOR INFORMATION 379 00:19:08,411 --> 00:19:10,713 AND I LOST MINE ON THE AIRPLANE. 380 00:19:10,713 --> 00:19:12,648 THEY'RE MEASURING YOU 24/7. 381 00:19:12,648 --> 00:19:14,517 I WON'T TALK ABOUT THIS TODAY 382 00:19:14,517 --> 00:19:16,219 BUT WE SHOWED YOU CAN PICK UP 383 00:19:16,219 --> 00:19:18,421 WHEN PEOPLE ARE GETTING 384 00:19:18,421 --> 00:19:19,188 INFECTIONS, LYME DISEASE AS WELL 385 00:19:19,188 --> 00:19:21,691 AS VIRAL INFECTIONS IN ADVANCE 386 00:19:21,691 --> 00:19:23,226 OF SYMPTOMS BECAUSE YOUR RESTING 387 00:19:23,226 --> 00:19:24,627 HEART RATE GOES UP. 388 00:19:24,627 --> 00:19:25,361 IT'S MORE SENSITIVE THAN 389 00:19:25,361 --> 00:19:28,731 TEMPERATURE WHICH IS WHAT WE DO 390 00:19:28,731 --> 00:19:28,998 TODAY. 391 00:19:28,998 --> 00:19:31,901 THAT'S A 300-YEAR-OLD CONCEPT 392 00:19:31,901 --> 00:19:34,036 WHICH DOESN'T WORK WELL FOR 393 00:19:34,036 --> 00:19:37,106 COVID AND RESTING PICK UP OTHER 394 00:19:37,106 --> 00:19:39,075 THINGS IN TERM OF MENTAL HEALTH 395 00:19:39,075 --> 00:19:39,375 STRESS. 396 00:19:39,375 --> 00:19:41,277 WE'RE RUNNING DIGITAL STUDIES 397 00:19:41,277 --> 00:19:43,212 WITH THE WEARABLES FOR MENTAL 398 00:19:43,212 --> 00:19:45,915 HEALTH CONDITIONS. 399 00:19:45,915 --> 00:19:48,584 SPECIFICALLY TRYING TO FOLLOW 400 00:19:48,584 --> 00:19:49,285 THINGS LIKE DEPRESSION. 401 00:19:49,285 --> 00:19:53,155 WE'RE RUNNING A STUDY MEASURED 402 00:19:53,155 --> 00:19:55,691 FOR WELLNESS MARKERS IF YOU WILL 403 00:19:55,691 --> 00:19:57,493 AS WELL AS RUNNING THROUGH AN 404 00:19:57,493 --> 00:19:59,028 INTERVENTION AND THIS IS FAIRLY 405 00:19:59,028 --> 00:20:00,463 PRELIMINARY AND WHAT WE 406 00:20:00,463 --> 00:20:02,298 DISCOVERED IS THAT YOU ACTUALLY 407 00:20:02,298 --> 00:20:03,733 CAN START MAKING CORRELATIONS 408 00:20:03,733 --> 00:20:06,035 BETWEEN MEASUREMENTS ON A DEVICE 409 00:20:06,035 --> 00:20:08,204 AND MENTAL HEALTH STATE, 410 00:20:08,204 --> 00:20:09,338 WELLNESS STATES. 411 00:20:09,338 --> 00:20:11,307 THIS IS AGAIN SOMEWHAT 412 00:20:11,307 --> 00:20:13,242 PRELIMINARY BUT SHOWS DATA. 413 00:20:13,242 --> 00:20:15,311 THERE'S VO2 MAX AND THIS IS 414 00:20:15,311 --> 00:20:18,447 HAPPINESS OF ALL THINGS AND DOES 415 00:20:18,447 --> 00:20:19,982 PAY TO SEGREGATE MALES AND 416 00:20:19,982 --> 00:20:20,783 FEMALES BECAUSE THE BASELINE ARE 417 00:20:20,783 --> 00:20:23,953 VERY DIFFERENT. 418 00:20:23,953 --> 00:20:25,688 YOU CAN PICK UP SIGNIFICANT 419 00:20:25,688 --> 00:20:27,256 SIGNALS BETWEEN THOSE HAPPY 420 00:20:27,256 --> 00:20:32,094 VERSUS NOT IN TERMS OF VO2 MAX 421 00:20:32,094 --> 00:20:34,997 AMONG MALES AND FEMALES 422 00:20:34,997 --> 00:20:38,434 BREATHING RATE DIFFERS AND YOU 423 00:20:38,434 --> 00:20:40,436 GET MARKERS AND WE ARE TRYING TO 424 00:20:40,436 --> 00:20:43,673 BRING MARKERS FOR COGNITION AND 425 00:20:43,673 --> 00:20:45,708 DEMENTIA WHICH CAN BE USEFUL AND 426 00:20:45,708 --> 00:20:47,543 THE POWER IS YOU'RE COLLECTING 427 00:20:47,543 --> 00:20:49,312 ALL PASSIVELY AND WE THINK IT'S 428 00:20:49,312 --> 00:20:50,079 QUITE VALUABLE. 429 00:20:50,079 --> 00:20:52,848 THE OTHER AREA IS GLUCOSE 430 00:20:52,848 --> 00:20:57,687 MONITORING I MYSELF AM A TYPE II 431 00:20:57,687 --> 00:20:57,954 DIABETIC. 432 00:20:57,954 --> 00:20:59,922 IT'S PERFECT FOR MENTAL HEALTH 433 00:20:59,922 --> 00:21:01,958 BECAUSE DIABETES IS VERY 434 00:21:01,958 --> 00:21:02,291 HETEROGENEOUS. 435 00:21:02,291 --> 00:21:04,260 WE LUMP IT ALL TOGETHER AND THE 436 00:21:04,260 --> 00:21:06,696 WAY WE TREAT IT SHOULDN'T BE BY 437 00:21:06,696 --> 00:21:08,030 LUMPING IT BECAUSE THERE'S 438 00:21:08,030 --> 00:21:09,732 DIFFERENT TREATMENTS FOR 439 00:21:09,732 --> 00:21:11,667 DIFFERENT CONDITIONS. 440 00:21:11,667 --> 00:21:13,769 WE DISCOVERED THE CONTINUOUS 441 00:21:13,769 --> 00:21:14,637 GLUCOSE MONITORING MEASURE EVERY 442 00:21:14,637 --> 00:21:17,807 FIVE MINUTES AND PUT THEM ON 443 00:21:17,807 --> 00:21:21,510 NORMAL AND PRE-DIABETICS AND 444 00:21:21,510 --> 00:21:25,047 HAVE GONE ON TO SHOW DIFFERENT 445 00:21:25,047 --> 00:21:26,582 PEOPLE SPIKE TO DIFFERENT FOODS. 446 00:21:26,582 --> 00:21:28,551 55 PEOPLE RUNNING THROUGH THE 447 00:21:28,551 --> 00:21:32,688 EXACT SAME AMOUNT OF CARBS AND 448 00:21:32,688 --> 00:21:33,489 DIFFERENT PEOPLE SPIKE TO 449 00:21:33,489 --> 00:21:35,257 DIFFERENT FOODS. 450 00:21:35,257 --> 00:21:37,526 THIS PERSON'S A BREAD SPIKER, 451 00:21:37,526 --> 00:21:41,931 THIS IS A GRAPE SPIKER AND MOST 452 00:21:41,931 --> 00:21:46,702 PEOPLE ARE WHITE RICE SPIKERS 453 00:21:46,702 --> 00:21:49,639 AND THINK OF THIS FROM AN 454 00:21:49,639 --> 00:21:50,306 ALZHEIMER'S STANDPOINT. 455 00:21:50,306 --> 00:21:51,907 CAN YOU SUB TYPE. 456 00:21:51,907 --> 00:21:53,709 WHICH FOODS WILL RESPOND TO 457 00:21:53,709 --> 00:21:55,277 WHICH SUBTYPES. 458 00:21:55,277 --> 00:21:58,180 IT TURNS OUT IF YOU'RE INSULIN 459 00:21:58,180 --> 00:21:59,448 RESISTANT YOU'RE ON AVERAGE 460 00:21:59,448 --> 00:22:03,719 GOING TO BE A POTATO AND PASTA 461 00:22:03,719 --> 00:22:05,221 SPIKER AND IT'S DIFFERENT IF YOU 462 00:22:05,221 --> 00:22:09,225 HAVE DIFFERENT SUBTYPES. 463 00:22:09,225 --> 00:22:11,394 YOUR LIFESTYLE WE'VE WRITTEN 464 00:22:11,394 --> 00:22:15,264 ALGORITHMS TO MATCH LIFESTYLES 465 00:22:15,264 --> 00:22:16,465 WITH PEOPLE'S RESPONSE AND 466 00:22:16,465 --> 00:22:17,266 USEFUL HEALTH THINGS. 467 00:22:17,266 --> 00:22:20,302 THE LAST THING IS THE IDEA OF 468 00:22:20,302 --> 00:22:21,270 HOME MICROSAMPLING. 469 00:22:21,270 --> 00:22:23,539 HERE'S HOW IT WORKS. 470 00:22:23,539 --> 00:22:26,142 YOU TAKE LITTLE DROPS OF BLOOD, 471 00:22:26,142 --> 00:22:29,612 MAIL TO US AND WE'LL DO DEEP 472 00:22:29,612 --> 00:22:31,981 PROFILES AND DIFFERENT OMICS AND 473 00:22:31,981 --> 00:22:35,051 MEASURE ABOUT 7,000 MARKERS IN A 474 00:22:35,051 --> 00:22:37,119 FAIRLY QUANTITATIVE FASHION. 475 00:22:37,119 --> 00:22:39,455 THESE ARE FAIRLY STABLE. 476 00:22:39,455 --> 00:22:41,991 WE'VE DONE A LOT OF WORK AND 477 00:22:41,991 --> 00:22:43,826 HAVE SEVERAL METHOD FOR 478 00:22:43,826 --> 00:22:45,628 COLLECTIONS. 479 00:22:45,628 --> 00:22:53,669 LIPIDS ARE A MIXED BAG AND IF 480 00:22:53,669 --> 00:22:57,073 YOU DRINK AN ENSURE SHAKE SOME 481 00:22:57,073 --> 00:22:58,040 PEOPLE IT WILL BE 482 00:22:58,040 --> 00:23:02,111 PRO-INFLAMMATORY FOR OTHERS 483 00:23:02,111 --> 00:23:02,578 ANTI-INFLAMMATORY. 484 00:23:02,578 --> 00:23:03,713 VERY DIFFERENT RESPONSE. 485 00:23:03,713 --> 00:23:06,348 THIS IS ONE PERSON WHO GOT A 486 00:23:06,348 --> 00:23:09,051 MICROSAMPLE EVERY HOUR FOR SEVEN 487 00:23:09,051 --> 00:23:11,220 STRAIGHT DAYS DURING WAKING 488 00:23:11,220 --> 00:23:14,690 HOURS WHILE WEARING A CGN AND 489 00:23:14,690 --> 00:23:18,694 SMART WATCH MEASURING FLEW COSE 490 00:23:18,694 --> 00:23:22,498 AND ACTIVITY AND -- GLUCOSE AND 491 00:23:22,498 --> 00:23:23,365 ACTIVITY AND WE'RE TRYING TO 492 00:23:23,365 --> 00:23:25,201 MATCH THEIR PHYSIOLOGY WITH 493 00:23:25,201 --> 00:23:26,702 LIFESTYLE AND STEPS AND OTHER 494 00:23:26,702 --> 00:23:30,706 THINGS THEY DO AND YOU CAN GET 495 00:23:30,706 --> 00:23:33,275 THOUSANDS OF CORRELATIONS. 496 00:23:33,275 --> 00:23:36,879 WE CAN MAKE CORRELATIONS BETWEEN 497 00:23:36,879 --> 00:23:42,218 ACTIVITY AND OTHER CYTOKINES AND 498 00:23:42,218 --> 00:23:42,451 LIPIDS. 499 00:23:42,451 --> 00:23:45,688 YOU CAN SEE THE PEPTIDES AND 500 00:23:45,688 --> 00:23:47,189 GLUCOSE AND YOU MEASURE 501 00:23:47,189 --> 00:23:49,458 PRECISELY FOR THIS PERSON AND 502 00:23:49,458 --> 00:23:51,560 TURNS OUT YOUR BLOOD IS BOUNCING 503 00:23:51,560 --> 00:23:51,794 AROUND. 504 00:23:51,794 --> 00:23:53,863 IT'S TOTAL BLOOD AND WE THINK 505 00:23:53,863 --> 00:23:54,697 IT'S FOLLOWING A PATTERN THAT'S 506 00:23:54,697 --> 00:23:58,100 SIMILAR TO STRESS. 507 00:23:58,100 --> 00:24:01,971 SO WE CAN MEASURE THE BLOOD. 508 00:24:01,971 --> 00:24:02,505 IT'S CONTROVERSIAL. 509 00:24:02,505 --> 00:24:03,973 THAT'S IT. 510 00:24:03,973 --> 00:24:06,709 HERE'S A SUMMARY. 511 00:24:06,709 --> 00:24:12,148 DEEP DATA LINK IS POWERFUL AND 512 00:24:12,148 --> 00:24:12,848 LONGITUDINAL MONITORING IS VERY 513 00:24:12,848 --> 00:24:13,749 POWERFUL AND HERE'S THE PEOPLE 514 00:24:13,749 --> 00:24:14,150 WHO DID THE WORK. 515 00:24:14,150 --> 00:24:24,293 THANKS. 516 00:24:39,475 --> 00:24:40,776 >> NOW RHODA AU FROM BOSTON 517 00:24:40,776 --> 00:24:41,844 UNIVERSITY. 518 00:24:41,844 --> 00:24:46,882 >> ONE THING I HOPE YOU TAKE 519 00:24:46,882 --> 00:24:52,454 AWAY IS DIGITAL BIOMARKERS AND 520 00:24:52,454 --> 00:24:53,756 PHENOTYPING HAVE NOT THE SAME 521 00:24:53,756 --> 00:24:57,393 THING AND WE HOPE TO GET TO 522 00:24:57,393 --> 00:24:57,693 BIOMARKERS. 523 00:24:57,693 --> 00:25:00,196 JUST TO GIVE YOU A LITTLE BIT OF 524 00:25:00,196 --> 00:25:01,931 CONTEXT WHERE DIGITAL NOW 525 00:25:01,931 --> 00:25:04,233 STANDS, SINCE THE LAST SUM IT 526 00:25:04,233 --> 00:25:06,635 WE'VE BEEN VERY PRODUCTIVE AS WE 527 00:25:06,635 --> 00:25:08,571 HEARD IN THE LAST COUPLE DAYS 528 00:25:08,571 --> 00:25:10,039 AND WILL FOR THE REMAINDER OF 529 00:25:10,039 --> 00:25:10,573 TODAY. 530 00:25:10,573 --> 00:25:14,176 WE'VE BEEN GENERATING LOTS OF 531 00:25:14,176 --> 00:25:14,743 SCIENCE IN THE ALZHEIMER'S 532 00:25:14,743 --> 00:25:15,744 DISEASE SPACE OVER THE LAST FEW 533 00:25:15,744 --> 00:25:21,383 YEARS. 534 00:25:21,383 --> 00:25:23,118 WHERE DOES DIGITAL FIT IN? 535 00:25:23,118 --> 00:25:25,554 THERE'S A FAIR NUMBER OF GROWING 536 00:25:25,554 --> 00:25:27,556 PUBLICATION INTERESTS IN THE 537 00:25:27,556 --> 00:25:29,792 AREA OF DIGITAL. 538 00:25:29,792 --> 00:25:32,061 IF YOU LOOK AT SPECIFICALLY AT 539 00:25:32,061 --> 00:25:33,495 THE CONCEPT OF DIGITAL 540 00:25:33,495 --> 00:25:35,531 BIOMARKERS YOU'LL FIND THAT'S A 541 00:25:35,531 --> 00:25:39,235 SMALLER SUBSET BUT ONE OF THE 542 00:25:39,235 --> 00:25:40,636 THINGS THAT'S VERY IMPORTANT TO 543 00:25:40,636 --> 00:25:42,972 REALIZE ABOUT THE LITERATURE 544 00:25:42,972 --> 00:25:45,741 TODAY IS THE ACTUAL NUMBER OF 545 00:25:45,741 --> 00:25:48,711 STUDIES DOING WORK RELATED TO 546 00:25:48,711 --> 00:25:51,580 DISCOVERY VALIDATION OF A 547 00:25:51,580 --> 00:25:53,282 DIGITAL BIOMARKER IS EVEN A 548 00:25:53,282 --> 00:25:54,516 SMALLER SUBSET. 549 00:25:54,516 --> 00:25:56,719 THE TAKE HOME MESSAGE IS IT'S 550 00:25:56,719 --> 00:25:57,519 NOW OF GREAT INTEREST. 551 00:25:57,519 --> 00:25:59,521 IT'S NO LONGER EMERGING. 552 00:25:59,521 --> 00:26:01,457 IT'S MOVING INTO THE MAINSTREAM 553 00:26:01,457 --> 00:26:02,725 BUT WE HAVE MANY MANY THINGS 554 00:26:02,725 --> 00:26:07,830 STILL LEFT TO DO. 555 00:26:07,830 --> 00:26:10,199 THE FDA TAKEN AN INTEREST IN THE 556 00:26:10,199 --> 00:26:12,401 CONCEPT OF DIGITAL BIOMARKERS 557 00:26:12,401 --> 00:26:13,769 AND STARTED TO PROVIDE SOME 558 00:26:13,769 --> 00:26:14,270 DEFINITION. 559 00:26:14,270 --> 00:26:16,105 I THINK THE MOST IMPORTANT THING 560 00:26:16,105 --> 00:26:19,608 IS WHEN WE'RE GOING TO DIGITAL, 561 00:26:19,608 --> 00:26:25,314 WE'RE TRYING TO CREATE OBJECTIVE 562 00:26:25,314 --> 00:26:29,218 MEASURES. 563 00:26:29,218 --> 00:26:32,121 IN THAT SENSE IT'S NO DIFFERENT 564 00:26:32,121 --> 00:26:35,491 FROM BIOMARKERS AND THE DIGITAL 565 00:26:35,491 --> 00:26:38,160 ERA IS HERE NOW. 566 00:26:38,160 --> 00:26:40,129 AS WE JUST HEARD THERE'S LOTS 567 00:26:40,129 --> 00:26:43,165 AND LOTS OF DEVICES, 568 00:26:43,165 --> 00:26:45,200 APPLICATIONS IN HOME SENSORS, 569 00:26:45,200 --> 00:26:45,467 ETCETERA. 570 00:26:45,467 --> 00:26:46,068 THIS IS GOING TO CONTINUE TO 571 00:26:46,068 --> 00:26:47,269 GROW. 572 00:26:47,269 --> 00:26:49,305 SO WE REALLY NEED TO THINK ABOUT 573 00:26:49,305 --> 00:26:52,541 HOW WE'RE GOING TO HARNESS THIS 574 00:26:52,541 --> 00:26:53,742 EXTRAORDINARY RESOURCE THAT 575 00:26:53,742 --> 00:26:56,412 WE'RE GENERATING ON A CONTINUOUS 576 00:26:56,412 --> 00:26:57,279 BASIS. 577 00:26:57,279 --> 00:27:00,316 SO IF WE THINK ABOUT DIGITAL 578 00:27:00,316 --> 00:27:02,685 BIOMARKERS TODAY WE'RE REALLY 579 00:27:02,685 --> 00:27:03,953 LOOKING AT ONES OBVIOUSLY 580 00:27:03,953 --> 00:27:07,923 DIAGNOSTIC AND THEN THE ONES 581 00:27:07,923 --> 00:27:11,794 THAT ARE REACTIVE TO TREATMENTS 582 00:27:11,794 --> 00:27:13,262 WHICH IS WHAT CLINICAL TRIALS IS 583 00:27:13,262 --> 00:27:15,731 INTERESTED IN AND THE CONCEPT OF 584 00:27:15,731 --> 00:27:18,200 ONGOING MONITORING FOR CHANGES 585 00:27:18,200 --> 00:27:19,601 RELATED TO THE DISEASE OF 586 00:27:19,601 --> 00:27:21,370 INTEREST WHICH IN THIS CASE IS 587 00:27:21,370 --> 00:27:22,738 ALZHEIMER'S DISEASE. 588 00:27:22,738 --> 00:27:26,709 SO IF WE THINK ABOUT ALL THE 589 00:27:26,709 --> 00:27:28,544 DIFFERENT WAYS IN WHICH WE CAN 590 00:27:28,544 --> 00:27:30,412 COLLECT DIGITAL DATA WHICH 591 00:27:30,412 --> 00:27:32,014 MICHAEL JUST TALKED ABOUT, I 592 00:27:32,014 --> 00:27:34,750 THINK THE IMPORTANT THING TO 593 00:27:34,750 --> 00:27:37,319 REMEMBER TODAY RIGHT NOW MUCH OF 594 00:27:37,319 --> 00:27:39,521 WHAT WE DO IS REALLY FALLING IN 595 00:27:39,521 --> 00:27:41,590 THE REALM OF DIGITAL 596 00:27:41,590 --> 00:27:42,257 PHENOTYPING. 597 00:27:42,257 --> 00:27:44,293 WE'RE MEASURING LOTS AND LOTS OF 598 00:27:44,293 --> 00:27:44,593 THINGS. 599 00:27:44,593 --> 00:27:49,031 THE GOAL HERE IS HOW DO WE GET 600 00:27:49,031 --> 00:27:53,302 FROM WHAT I SAY IS MOSTLY 601 00:27:53,302 --> 00:27:55,504 DERIVED MEASURES FROM DIGITAL 602 00:27:55,504 --> 00:27:55,838 DEVICES. 603 00:27:55,838 --> 00:27:59,074 THESE ARE DIGITAL MEASURES OF 604 00:27:59,074 --> 00:28:00,442 BEHAVIORS OF INTEREST. 605 00:28:00,442 --> 00:28:03,879 AND I THINK THE REAL GOAL IS HOW 606 00:28:03,879 --> 00:28:06,281 DO WE GET TO THIS NEW REALITY OF 607 00:28:06,281 --> 00:28:08,484 WHAT A DIGITAL BIOMARKER IS 608 00:28:08,484 --> 00:28:09,051 LIKELY TO BE. 609 00:28:09,051 --> 00:28:10,652 BECAUSE OF THE WAY IN WHICH 610 00:28:10,652 --> 00:28:12,054 WE'RE COLLECTING THE DATA 611 00:28:12,054 --> 00:28:12,988 THROUGH ALL THESE DIFFERENT 612 00:28:12,988 --> 00:28:16,058 TYPES OF APPLICATIONS, DEVICES, 613 00:28:16,058 --> 00:28:18,694 SENSORS, ETCETERA, I THINK WHAT 614 00:28:18,694 --> 00:28:20,996 WE HAVE TO RETHINK IS WHAT DOES 615 00:28:20,996 --> 00:28:23,599 THE BIOMARKER SIGNAL REALLY LOOK 616 00:28:23,599 --> 00:28:23,899 LIKE? 617 00:28:23,899 --> 00:28:26,068 I THINK IT'S GOING TO BE VERY 618 00:28:26,068 --> 00:28:28,837 DYNAMIC, FLOWING, CHANGING 619 00:28:28,837 --> 00:28:29,805 REFLECTING THE HETEROGENEITY IN 620 00:28:29,805 --> 00:28:33,075 ALL THESE BEHAVIORS OF INTEREST. 621 00:28:33,075 --> 00:28:35,844 SO I THINK THAT'S THE REAL 622 00:28:35,844 --> 00:28:36,111 CHALLENGE. 623 00:28:36,111 --> 00:28:37,079 I'M GOING TO JUST SHIFT A LITTLE 624 00:28:37,079 --> 00:28:38,680 BIT AND TALK ABOUT SOME OF THE 625 00:28:38,680 --> 00:28:45,754 WORK THAT MY COLLEAGUES HAVE 626 00:28:45,754 --> 00:28:53,729 DONE IN LOOKING AT SOME OF THE 627 00:28:53,729 --> 00:28:55,831 VOICE RECORDINGS THROUGH THE 628 00:28:55,831 --> 00:28:57,299 FRAMINGHAM HEART STUDY. 629 00:28:57,299 --> 00:29:00,102 WHAT'S IMPORTANT ABOUT WHAT THE 630 00:29:00,102 --> 00:29:02,237 PAPER HAS DONE IS USING 631 00:29:02,237 --> 00:29:03,705 AUTOMATED PROCESSING. 632 00:29:03,705 --> 00:29:08,410 IT'S COMPLETELY DATA SCIENCE 633 00:29:08,410 --> 00:29:10,712 A.I.-DRIVEN, HANDS FREE. 634 00:29:10,712 --> 00:29:14,216 THERE'S NO MANUAL INTERVENTION. 635 00:29:14,216 --> 00:29:16,685 THEY TOOK RECORDINGS WE HAVE 636 00:29:16,685 --> 00:29:17,319 BEEN COLLECTING SINCE 2005 IN 637 00:29:17,319 --> 00:29:20,622 THE COHORT AND FOLLOWED THEM 638 00:29:20,622 --> 00:29:22,691 LONGITUDINALLY FOR INCIDENT 639 00:29:22,691 --> 00:29:28,297 CHANGES IN MCI AND 2 DEMENTIA. 640 00:29:28,297 --> 00:29:32,835 THE TEAM TOOK ALL THOSE 641 00:29:32,835 --> 00:29:36,238 RECORDINGS, PROCESSED THEM, 642 00:29:36,238 --> 00:29:36,805 EXTRACTED AUTOMATED 643 00:29:36,805 --> 00:29:42,711 TRANSCRIPTIONS AND ANALYZED 644 00:29:42,711 --> 00:29:44,012 THAT. 645 00:29:44,012 --> 00:29:46,515 IN LOOKING AT THE ABILITY OF 646 00:29:46,515 --> 00:29:49,184 PREDICTION OF LATER ONSET 647 00:29:49,184 --> 00:29:51,753 DEMENTIA THEY FOUND IT'S THE 648 00:29:51,753 --> 00:29:54,656 SPEECH RELATED MEASURES THAT 649 00:29:54,656 --> 00:29:58,660 WERE MOST PREDICTIVE COMPARED TO 650 00:29:58,660 --> 00:30:00,596 SOME OTHER MEASURES OF INTEREST 651 00:30:00,596 --> 00:30:06,068 THAT ARE TYPICALLY USED TO 652 00:30:06,068 --> 00:30:06,468 EVALUATE DEMENTIA. 653 00:30:06,468 --> 00:30:12,774 AND I THINK WHAT'S IMPORTANT IS 654 00:30:12,774 --> 00:30:14,776 THAT THE SPEECH ALONE WAS ABLE 655 00:30:14,776 --> 00:30:18,113 TO PREDICT WITH ALMOST AS GREAT 656 00:30:18,113 --> 00:30:19,581 AS SENSITIVITY IF YOU COMBINE 657 00:30:19,581 --> 00:30:19,781 THEM. 658 00:30:19,781 --> 00:30:22,384 YOU DON'T GET A LOT OF ADDED 659 00:30:22,384 --> 00:30:25,287 VALUE BY ADDING IN ADDITIONAL 660 00:30:25,287 --> 00:30:27,089 INFORMATION AND THIS HIGHLIGHTS 661 00:30:27,089 --> 00:30:30,592 HOW MUCH SPEECH AS A POTENTIAL 662 00:30:30,592 --> 00:30:33,262 MEASURE OF COGNITION AND AS A 663 00:30:33,262 --> 00:30:35,264 MEASURE PREDICTIVE OF LATER 664 00:30:35,264 --> 00:30:38,767 POTENTIAL ONSET OF DEMENTIA CAN 665 00:30:38,767 --> 00:30:42,037 BE VERY POWERFUL. 666 00:30:42,037 --> 00:30:43,906 AND THE REASON I LIKE TO 667 00:30:43,906 --> 00:30:46,842 HIGHLIGHT DIGITAL VOICE IS 668 00:30:46,842 --> 00:30:54,249 BECAUSE IT'S SO EASY TO COLLECT. 669 00:30:54,249 --> 00:30:57,219 IN ADDITION TO THE FRAMINGHAM 670 00:30:57,219 --> 00:30:58,954 HEART STUDY SINCE 2005 THE 671 00:30:58,954 --> 00:31:00,055 ALZHEIMER'S RESEARCH CENTERS ARE 672 00:31:00,055 --> 00:31:02,691 ABOUT TO LAUNCH AND START 673 00:31:02,691 --> 00:31:03,825 COLLECTING DIGITAL VOICE AS WELL 674 00:31:03,825 --> 00:31:09,765 AS PART OF THEIR UDS4.0 AND WE 675 00:31:09,765 --> 00:31:14,369 HAVE ADNI. 676 00:31:14,369 --> 00:31:16,772 WHAT'S HAPPENING IS BECAUSE IT'S 677 00:31:16,772 --> 00:31:21,076 SO EASY TO COMPLEX AND SPEAKING 678 00:31:21,076 --> 00:31:22,711 IS A COGNITIVELY COMPLEX TASK 679 00:31:22,711 --> 00:31:24,880 IT'S ABLE TO PUSH FORWARD AT A 680 00:31:24,880 --> 00:31:26,682 SCALABLE LEVEL QUICKLY. 681 00:31:26,682 --> 00:31:28,917 IF WE THINK WHERE WE ARE TODAY, 682 00:31:28,917 --> 00:31:31,019 WE'VE BEEN COLLECTING LOTS OF 683 00:31:31,019 --> 00:31:33,155 DATA AND NOW WE'RE STARTING TO 684 00:31:33,155 --> 00:31:36,858 COLLECT DIGITAL DATA. 685 00:31:36,858 --> 00:31:42,531 HERE'S THE PROBLEM, THE 686 00:31:42,531 --> 00:31:43,165 INTEROPERABILITY PLATFORMS 687 00:31:43,165 --> 00:31:44,566 ACTUALLY CAN'T STORE ALL THIS 688 00:31:44,566 --> 00:31:46,702 DIGITAL DATA AND THEREFORE WE 689 00:31:46,702 --> 00:31:49,538 HAVE A DISCONNECT AS A RESULT 690 00:31:49,538 --> 00:31:52,341 WHAT'S HAPPENING IS WE HAVE ALL 691 00:31:52,341 --> 00:31:54,109 THIS GREAT CLINICAL AND 692 00:31:54,109 --> 00:31:56,044 BIOMARKER DATA AND GREAT DIGITAL 693 00:31:56,044 --> 00:31:57,346 DATA YET WE'RE NOT ABLE TO DO 694 00:31:57,346 --> 00:32:00,082 THE SCIENCE OF COMBINING THEM 695 00:32:00,082 --> 00:32:00,349 TOGETHER. 696 00:32:00,349 --> 00:32:03,752 SO AS WE THINK ABOUT HOW TO GO 697 00:32:03,752 --> 00:32:05,487 FORWARD, BLOOD CONTINUES TO LEAD 698 00:32:05,487 --> 00:32:07,556 THE CHANGE AND IT'S ALSO EASY TO 699 00:32:07,556 --> 00:32:09,758 COLLECT, STORE AND THEN ANALYZE 700 00:32:09,758 --> 00:32:11,293 AND WE HAVE. 701 00:32:11,293 --> 00:32:13,495 WE'VE ANALYZED IT FROM A NUMBER 702 00:32:13,495 --> 00:32:17,733 OF NOW EMERGING BIOMARKERS AS 703 00:32:17,733 --> 00:32:19,968 WELL GENETIC, GENOMICS, 704 00:32:19,968 --> 00:32:20,235 ETCETERA. 705 00:32:20,235 --> 00:32:22,471 I LIKE TO THINK ABOUT DIGITAL IN 706 00:32:22,471 --> 00:32:22,971 THE SAME WAY. 707 00:32:22,971 --> 00:32:25,774 THERE'S LOTS AND LOTS OF DEVICES 708 00:32:25,774 --> 00:32:28,076 NOW THAT CAN COLLECT DIGITAL 709 00:32:28,076 --> 00:32:28,644 DATA. 710 00:32:28,644 --> 00:32:32,080 YOU CAN ACTUALLY STORE THE DATA 711 00:32:32,080 --> 00:32:33,782 LIKE YOU WOULD BLOOD AND THEN 712 00:32:33,782 --> 00:32:39,421 YOU CAN PUSH THIS DATA OUT AND 713 00:32:39,421 --> 00:32:42,791 SHARE IT IN THIS KAY START TO 714 00:32:42,791 --> 00:32:44,926 MOVE TO THE DIGITAL BIOMARKER 715 00:32:44,926 --> 00:32:46,261 REALITY I PRESENTED EARLIER AND 716 00:32:46,261 --> 00:32:49,064 I'D LIKE TO THINK ABOUT DIGITAL 717 00:32:49,064 --> 00:32:52,567 THEN AS BEING THE NEW BLOOD. 718 00:32:52,567 --> 00:32:54,703 SO AS WE SORT OF MOVE INTO THIS 719 00:32:54,703 --> 00:32:57,372 REALM WHERE WE NEED TO NOW 720 00:32:57,372 --> 00:32:59,908 COMBINE ALL THESE DIFFERENT 721 00:32:59,908 --> 00:33:00,609 BIOMARKERS OF INTEREST TOGETHER 722 00:33:00,609 --> 00:33:02,678 I THINK WHAT WE WANT TO TAKE 723 00:33:02,678 --> 00:33:04,780 TAKEAWAY FROM US IS WE'RE AT A 724 00:33:04,780 --> 00:33:07,115 POINT WHERE WE KNOW LONGER HAVE 725 00:33:07,115 --> 00:33:08,216 TO BE PATIENT WAITING FOR THIS 726 00:33:08,216 --> 00:33:11,787 TO HAPPEN BECAUSE IT'S NOW READY 727 00:33:11,787 --> 00:33:13,522 TO HAPPEN TODAY. 728 00:33:13,522 --> 00:33:20,829 WITH THAT I ENDED EARLY. 729 00:33:20,829 --> 00:33:23,365 >> THANK YOU SO MUCH, DR. AU. 730 00:33:23,365 --> 00:33:25,600 THE NEXT SPEAKER IS LEE 731 00:33:25,600 --> 00:33:26,468 GOLDSTEIN ALSO FROM BOSTON 732 00:33:26,468 --> 00:33:26,768 UNIVERSITY. 733 00:33:26,768 --> 00:33:36,912 WELCOME. 734 00:33:40,949 --> 00:33:41,983 >> THANK YOU. 735 00:33:41,983 --> 00:33:43,218 I'VE BEEN ASKED TO TALK ABOUT 736 00:33:43,218 --> 00:33:45,287 OCULAR BIOMARKERS WITH THE FOCUS 737 00:33:45,287 --> 00:33:46,521 ON THE LENS. 738 00:33:46,521 --> 00:33:49,291 MY DISCLOSURES ARE LISTED BELOW. 739 00:33:49,291 --> 00:33:51,760 TO REMIND YOU FROM JUNIOR HIGH 740 00:33:51,760 --> 00:33:52,594 SCHOOL OR HIGH SCHOOL BIOLOGY 741 00:33:52,594 --> 00:33:55,063 THE LENS IS PART OF THE EYE. 742 00:33:55,063 --> 00:33:58,900 IT'S NOT A PIECE OF GLASS IN 743 00:33:58,900 --> 00:34:01,536 YOUR HEAD IT'S A LIVING TISSUE 744 00:34:01,536 --> 00:34:03,472 IN THE EYE AND WILL REMAIN A 745 00:34:03,472 --> 00:34:05,240 LIVING TISSUE LONGER THAN YOU'LL 746 00:34:05,240 --> 00:34:07,042 BE ALIVE. 747 00:34:07,042 --> 00:34:09,144 OFTEN BY AS MANY AS DAYS TO 748 00:34:09,144 --> 00:34:09,711 WEEKS. 749 00:34:09,711 --> 00:34:15,417 IT'S IN THE ANTERIOR COMPARTMENT 750 00:34:15,417 --> 00:34:21,623 BEHIND THE CORNEA AND AQUEOUS 751 00:34:21,623 --> 00:34:24,259 FLUID AND RECITES HERE. 752 00:34:24,259 --> 00:34:25,694 IT GROWS THROUGHOUT LIFE 753 00:34:25,694 --> 00:34:26,762 ACTUALLY BEFORE LIFE AND 754 00:34:26,762 --> 00:34:28,163 CONTINUES AFTER LIFE, BELIEVE IT 755 00:34:28,163 --> 00:34:28,830 OR NOT. 756 00:34:28,830 --> 00:34:32,401 YOU HAVE THE OLDEST PROTEIN IN 757 00:34:32,401 --> 00:34:34,302 THE BODY ONE OF THE FEW PLACES 758 00:34:34,302 --> 00:34:35,771 WHERE YOU HAVE PROTEIN FROM 759 00:34:35,771 --> 00:34:37,672 BEFORE BIRTH AND WE USE THIS FOR 760 00:34:37,672 --> 00:34:38,707 ANOTHER TYPE OF TECHNOLOGY TO 761 00:34:38,707 --> 00:34:41,143 LOOK AT MOLECULAR AGING. 762 00:34:41,143 --> 00:34:42,711 WE HAVE SOME PUBLICATIONS ON 763 00:34:42,711 --> 00:34:44,913 THAT I WON'T GET INTO HERE. 764 00:34:44,913 --> 00:34:48,550 THESE ARE POTENTIALLY RELATED 765 00:34:48,550 --> 00:34:50,085 STEM CELLS THAT RESIDE THROUGH 766 00:34:50,085 --> 00:34:55,490 LIFE AND DIFFERENTIATE INTO 767 00:34:55,490 --> 00:34:57,759 FIBER CELLS AND GROWS LIKE A 768 00:34:57,759 --> 00:35:01,430 TREE WITH GROWTH RINGS AND THE 769 00:35:01,430 --> 00:35:05,200 PATHOLOGY IS UNDER THE IRIS AT 770 00:35:05,200 --> 00:35:08,036 THE POSTERIOR REGION WHICH IS 771 00:35:08,036 --> 00:35:10,705 NOT LONG THE OPTICAL AXIS. 772 00:35:10,705 --> 00:35:13,141 THE DOESN'T IMPAIR VISION AND 773 00:35:13,141 --> 00:35:17,045 THE CELLS ARE VERY MUCH ALIVE 774 00:35:17,045 --> 00:35:18,914 AND THE ONES IN THE CENTER ARE 775 00:35:18,914 --> 00:35:21,550 OLDER THAN YOU ARE AND THE 776 00:35:21,550 --> 00:35:22,184 DIFFERENTIATION PROCESS OCCURS 777 00:35:22,184 --> 00:35:24,653 WHERE I'LL SHOW YOU THE 778 00:35:24,653 --> 00:35:24,920 PATHOLOGY. 779 00:35:24,920 --> 00:35:29,758 THERE'S RELATIONSHIP WITH 780 00:35:29,758 --> 00:35:34,329 NEURONS AT THE TERMINAL DE RIFF 781 00:35:34,329 --> 00:35:38,733 TIFS FROM STEM CELLS AND 782 00:35:38,733 --> 00:35:41,403 POST-MITOTIC AND THE MACHINERY 783 00:35:41,403 --> 00:35:45,807 FOR REGENERATING BETA PATHOLOGY 784 00:35:45,807 --> 00:35:46,741 IS PRESENT. 785 00:35:46,741 --> 00:35:50,712 BACK IN 2003 WE REPORTED IN THE 786 00:35:50,712 --> 00:35:53,682 LANCET THIS USUAL FINDING TOO 787 00:35:53,682 --> 00:35:57,786 UNUSUAL FOR PSYCHIATRISTS 788 00:35:57,786 --> 00:36:03,825 REPORTING OPHTHALMALGIC FINDINGS 789 00:36:03,825 --> 00:36:07,295 AND IT TURNS OUT WE HAVE BETA 790 00:36:07,295 --> 00:36:10,599 AMYLOID AND IT'S EQUIVALENT TO 791 00:36:10,599 --> 00:36:11,967 LATE PLAQUE. 792 00:36:11,967 --> 00:36:13,301 THE MOLECULAR PATHOLOGY BEFORE 793 00:36:13,301 --> 00:36:14,469 THIS IS THE KEY. 794 00:36:14,469 --> 00:36:16,438 WE WON'T LOOK FOR THE CATARACT. 795 00:36:16,438 --> 00:36:19,474 THIS IS A SIGNATURE TIME PART. 796 00:36:19,474 --> 00:36:22,544 THESE ARE VARIOUS PAPERS RELATED 797 00:36:22,544 --> 00:36:23,044 TO THIS. 798 00:36:23,044 --> 00:36:26,314 WE COLLECTED A BUNCH OF LENSES 799 00:36:26,314 --> 00:36:29,084 FROM ANATOMIC DONORS WHO DONATED 800 00:36:29,084 --> 00:36:30,785 EYES AND BRAIN. 801 00:36:30,785 --> 00:36:38,193 ALL THESE WERE A.D. PATHOLOGY 802 00:36:38,193 --> 00:36:40,729 CONTROLLED CASES AND HERE'S THE 803 00:36:40,729 --> 00:36:43,431 CATARACT AND IT'S ABETA. 804 00:36:43,431 --> 00:36:45,267 THIS IS AMYLOID PANELOLOGY IN 805 00:36:45,267 --> 00:36:48,737 THE LENS OF THE EYE. 806 00:36:48,737 --> 00:36:51,540 HERE'S AN AGE RELATED NUCLEAR 807 00:36:51,540 --> 00:36:54,743 CATARACT THAT HAS NOTHING TO DO 808 00:36:54,743 --> 00:36:56,244 WITH ALZHEIMER'S DISEASE. 809 00:36:56,244 --> 00:36:58,079 COMORBID IN THE SAME LENS. 810 00:36:58,079 --> 00:37:00,682 YOU SEE DIFFERENT POLYMORPHIC 811 00:37:00,682 --> 00:37:01,583 EXPRESSION AND IT'S AGE 812 00:37:01,583 --> 00:37:01,850 DEPENDENT. 813 00:37:01,850 --> 00:37:09,791 WE DON'T SEE THIS IN ANY OTHER 814 00:37:09,791 --> 00:37:12,227 NON-A.D. DEMENTING DISORDER BY 815 00:37:12,227 --> 00:37:17,032 VIRAL PENETRANT AND ANATOMICALLY 816 00:37:17,032 --> 00:37:27,576 DISTINCT AND PATHOPHYSIOLIGIALLY 817 00:37:34,583 --> 00:37:41,022 AND LOOK AT CATARACTS AND THE 818 00:37:41,022 --> 00:37:44,225 PHENOTYPE IS IDENTICAL TO WHAT 819 00:37:44,225 --> 00:37:52,300 WE SEE IN A.D. AND IS SHOWING 820 00:37:52,300 --> 00:37:54,536 FROM THE BRAIN IN THIS DISORDER. 821 00:37:54,536 --> 00:37:56,071 I DRAW YOUR ATTENTION TO THIS 822 00:37:56,071 --> 00:37:57,105 ONE RIGHT HERE. 823 00:37:57,105 --> 00:38:00,241 THIS IS FROM AN 18 MONTH OLD 824 00:38:00,241 --> 00:38:07,215 WITHOUT ANY EVIDENCE OF THE 825 00:38:07,215 --> 00:38:08,817 SIGNATURE SUPER NUCLEAR CATARACT 826 00:38:08,817 --> 00:38:12,253 AND SEE THE AGE DEPENDENCE HERE. 827 00:38:12,253 --> 00:38:14,556 YOU'LL SEE RIGHT HERE, THIS IS 828 00:38:14,556 --> 00:38:16,391 AN EARLIER SLIDE, THE SAME CASE 829 00:38:16,391 --> 00:38:17,058 RIGHT HERE. 830 00:38:17,058 --> 00:38:19,294 WHEN WE LOOK AT THE A BETA IN 831 00:38:19,294 --> 00:38:22,731 THAT REGION OF THE LENS, THIS IS 832 00:38:22,731 --> 00:38:25,867 MORE ABETA THEN WHAT WE SEE IN A 833 00:38:25,867 --> 00:38:29,237 LENS FROM AN INSTATE FAD CASE 834 00:38:29,237 --> 00:38:33,475 FROM A 57 AND 59-YEAR-OLD. 835 00:38:33,475 --> 00:38:36,344 EXTRAORDINARY AMOUNTS OF A BETA. 836 00:38:36,344 --> 00:38:38,179 WE SEE IT IN DOWN SYNDROME EARLY 837 00:38:38,179 --> 00:38:41,316 BEFORE YOU SEE ELEVATED A BETA 838 00:38:41,316 --> 00:38:43,018 IN THE DOWN SYNDROME BRAIN. 839 00:38:43,018 --> 00:38:47,322 MOREOVER IT PRECEDES THE SUPER 840 00:38:47,322 --> 00:38:47,922 NUCLEAR PHENOTYPE. 841 00:38:47,922 --> 00:38:49,658 SO THIS IS EXTRAORDINARY LEVELS 842 00:38:49,658 --> 00:38:52,093 OF A BETA WE CAN DETECT. 843 00:38:52,093 --> 00:38:53,695 WE TO THE THERE'S A 844 00:38:53,695 --> 00:38:59,167 CO-LOCALIZATION OF THE PATHOLOGY 845 00:38:59,167 --> 00:39:02,604 AND WE KNOW WHAT CAUSES THE 846 00:39:02,604 --> 00:39:04,406 CATARACT ITSELF, LIGHT 847 00:39:04,406 --> 00:39:07,375 SCATTERING FROM THE A BETA AND 848 00:39:07,375 --> 00:39:08,777 ALPHA B CRYSTALLIN. 849 00:39:08,777 --> 00:39:10,011 WE LEARNED SOMETHING ABOUT THE 850 00:39:10,011 --> 00:39:11,846 BRAIN FROM LOOKING IN THE LENS. 851 00:39:11,846 --> 00:39:15,150 WE CAN SEE THE INTERACTION 852 00:39:15,150 --> 00:39:18,353 BETWEEN ALPHA B CRYSTALLIN AND 853 00:39:18,353 --> 00:39:21,256 HAVE A PAPER COMING OUT SOON AND 854 00:39:21,256 --> 00:39:27,595 KNOW IT'S A BETA BY CHEMICAL AND 855 00:39:27,595 --> 00:39:28,463 MASS SPECTOMETRY METHODS. 856 00:39:28,463 --> 00:39:33,802 THIS LED TO OUR INITIAL 857 00:39:33,802 --> 00:39:41,443 DEVELOPMENT WORK STARTED WITH 858 00:39:41,443 --> 00:39:44,446 THE AMERICAN HEALTH ASSISTANCE 859 00:39:44,446 --> 00:39:45,747 ACROSS TOWN AND COMMERCIALIZED 860 00:39:45,747 --> 00:39:49,417 THROUGH A COMPANY I STARTED AND 861 00:39:49,417 --> 00:39:51,786 DISCLOSED, BY THE WAY, TO PICK 862 00:39:51,786 --> 00:39:54,723 UP NOT THE CATARACT BUT THE 863 00:39:54,723 --> 00:39:55,690 MOLECULAR PATHOLOGY. 864 00:39:55,690 --> 00:40:02,731 THIS IS BASED ON A FLUORESCENT A 865 00:40:02,731 --> 00:40:07,435 BETA BINDING AND IT'S BEEN 866 00:40:07,435 --> 00:40:09,771 COMPOUNDED ON ATOM CAL 867 00:40:09,771 --> 00:40:16,711 APPLICATION AND COMBINES ABETA. 868 00:40:16,711 --> 00:40:20,782 WE CAN APPLY THIS TO THE EYE 869 00:40:20,782 --> 00:40:26,054 DIRECTLY AND DETECTING USING 870 00:40:26,054 --> 00:40:28,923 FLUORESCENCE LIFE TIME DECAY 871 00:40:28,923 --> 00:40:29,257 SPECTROSCOPY. 872 00:40:29,257 --> 00:40:33,161 WE WANT TO PICK UP THE MOLECULAR 873 00:40:33,161 --> 00:40:34,028 SIGNATURES AND HAVE LATER 874 00:40:34,028 --> 00:40:36,731 VERSIONS OF THIS AND WE HAVE 875 00:40:36,731 --> 00:40:42,203 EARLY CLINICAL DATA THE COMPANY 876 00:40:42,203 --> 00:40:43,872 CONDUCTED SHOWING IT'S 877 00:40:43,872 --> 00:40:44,172 EFFICACIOUS. 878 00:40:44,172 --> 00:40:45,940 THIS IS A DRUG DEVICE PRODUCT 879 00:40:45,940 --> 00:40:47,776 AND IT'S RECEIVED FDA 880 00:40:47,776 --> 00:40:57,786 BREAKTHROUGH DESIGNATION STATUS. 881 00:40:57,786 --> 00:41:00,321 IN SUMMARY WE SHOWED THE A BETA 882 00:41:00,321 --> 00:41:03,024 PHENOTYPE SPECIFIC TO LATE ONSET 883 00:41:03,024 --> 00:41:04,592 ALZHEIMER'S DISEASE. 884 00:41:04,592 --> 00:41:07,796 WE SEE THE SAME PHENOTYPE IN 885 00:41:07,796 --> 00:41:09,464 DOWN SYNDROME. 886 00:41:09,464 --> 00:41:13,168 AND WE WORKED THIS OUT IN THE 887 00:41:13,168 --> 00:41:14,736 TG2 TRANSGENIC MOUSE A COUPLE 888 00:41:14,736 --> 00:41:16,037 YEARS AGO. 889 00:41:16,037 --> 00:41:18,006 WE SHOWED THERE'S AN AGE 890 00:41:18,006 --> 00:41:18,706 DEPENDENCE TO THIS EXPRESSION. 891 00:41:18,706 --> 00:41:23,912 I MENTIONED EARLIER ABOUT THE 892 00:41:23,912 --> 00:41:27,782 AQUEOUS HUMOR EQUIVALENT TO ACF 893 00:41:27,782 --> 00:41:31,319 AND WERE THE FIRST TO REPORT A 894 00:41:31,319 --> 00:41:35,490 BETA HERE AND IT TURNS OUT THE A 895 00:41:35,490 --> 00:41:37,158 BETA 40 TO 42 THE CONCENTRATION 896 00:41:37,158 --> 00:41:40,228 IS SIMILAR TO CSF. 897 00:41:40,228 --> 00:41:41,429 USING THE TECHNOLOGY I JUST 898 00:41:41,429 --> 00:41:45,333 SHOWED YOU THERE'S POTENTIAL TO 899 00:41:45,333 --> 00:41:50,705 USE THIS OPTICAL PERISENTISIS 900 00:41:50,705 --> 00:41:53,675 AND LOOK AT A BETA GENERATION 901 00:41:53,675 --> 00:41:54,142 USING THE TECHNOLOGY. 902 00:41:54,142 --> 00:41:58,146 THAT'S IN THE FUTURE BUT HAS 903 00:41:58,146 --> 00:41:58,746 POSSIBILITY. 904 00:41:58,746 --> 00:42:00,448 I MENTIONED WHY WE GET THE 905 00:42:00,448 --> 00:42:02,250 CATARACT THE FOCAL SCATTER IN 906 00:42:02,250 --> 00:42:06,621 WHICH THE A BETA ACCUMULATES AND 907 00:42:06,621 --> 00:42:08,890 RECEIVED FDA BREAKTHROUGH DEVICE 908 00:42:08,890 --> 00:42:11,492 DESIGNATION AND AS MENTIONED 909 00:42:11,492 --> 00:42:13,828 YESTERDAY THIS TAKES A HECK OF A 910 00:42:13,828 --> 00:42:16,598 LONG TIME IN THE LIFE SPAN OF 911 00:42:16,598 --> 00:42:19,868 ONE LAB, ONE GROUP TO DEVELOP 912 00:42:19,868 --> 00:42:22,203 THESE TECHNOLOGIES FROM THE 913 00:42:22,203 --> 00:42:25,139 FLOOR UP TO INITIAL DISCOVERY 914 00:42:25,139 --> 00:42:26,374 AND THANKFUL FOR NIH SUPPORT TO 915 00:42:26,374 --> 00:42:29,944 TRY TO DO THE VALIDATION STUDIES 916 00:42:29,944 --> 00:42:31,212 AND COLLABORATIONS AS WE MOVE TO 917 00:42:31,212 --> 00:42:35,817 THE CLINIC. 918 00:42:35,817 --> 00:42:40,688 THANK YOU VERY MUCH. 919 00:42:40,688 --> 00:42:42,423 >> THANK YOU. 920 00:42:42,423 --> 00:42:47,996 NEXT SPEAKER IS DR. MATTHIAS 921 00:42:47,996 --> 00:42:50,732 ARNOLD FROM HELMHOLTZ 922 00:42:50,732 --> 00:42:51,032 UNIVERSITY. 923 00:42:51,032 --> 00:42:52,934 WELCOME. 924 00:42:52,934 --> 00:42:54,535 >> THANK YOU VERY MUCH. 925 00:42:54,535 --> 00:42:56,771 SO I'VE BEEN INSTRUCTED BY NIH 926 00:42:56,771 --> 00:43:03,144 TO NOT WASTE MY TIME WITH 927 00:43:03,144 --> 00:43:07,282 ACKNOWLEDGE MANIES. 928 00:43:07,282 --> 00:43:09,751 -- ACKNOWLEDGEMENTS AND THE 929 00:43:09,751 --> 00:43:14,088 WORK IS THE WORK OF MANY IN THE 930 00:43:14,088 --> 00:43:18,359 METABOLISM CONSORTIUM AND 931 00:43:18,359 --> 00:43:23,765 WITHOUT THE PARTICIPANTS OF THE 932 00:43:23,765 --> 00:43:27,201 STUDIES AND I'LL TALK ABOUT HOW 933 00:43:27,201 --> 00:43:29,504 METABOLOMIC CAN HELP BROADEN THE 934 00:43:29,504 --> 00:43:32,573 PORTFOLIO OF BIOMARKERS WE HAVE 935 00:43:32,573 --> 00:43:34,575 FOR ALZHEIMER'S DISEASE. 936 00:43:34,575 --> 00:43:36,077 METABOLOMICS IS THE STUDY OF THE 937 00:43:36,077 --> 00:43:37,845 HUMAN METABOLOME. 938 00:43:37,845 --> 00:43:41,316 AND TO GIVE YOU AN IDEA OF WHAT 939 00:43:41,316 --> 00:43:42,250 WE'RE WORKING WITH AND WE PUT 940 00:43:42,250 --> 00:43:45,820 THE CONTENT MUCH A PLATFORM THAT 941 00:43:45,820 --> 00:43:47,188 WE'RE REGULARLY USING ON THE TOP 942 00:43:47,188 --> 00:43:48,923 LEFT OF THE SLIDE. 943 00:43:48,923 --> 00:43:51,693 WHAT YOU SEE IS METABOLOMICS NOT 944 00:43:51,693 --> 00:43:54,796 ONLY COVERS THE BUILDING BLOCKS 945 00:43:54,796 --> 00:44:01,736 OF NUCLEOTIDES OR AMINO ACIDS 946 00:44:01,736 --> 00:44:05,473 FOR PROTEINS BUT COVERS AND 947 00:44:05,473 --> 00:44:10,345 COVER LIPIDS. 948 00:44:10,345 --> 00:44:15,183 WHAT IS ALSO IMPORTANT AND ARE 949 00:44:15,183 --> 00:44:22,724 BY FUNCTION AND CLASS BEHIND BY 950 00:44:22,724 --> 00:44:27,829 ENZYMATIC REACTIONS AND IT'S 951 00:44:27,829 --> 00:44:34,736 HIGHLY DYNAMIC. 952 00:44:34,736 --> 00:44:36,270 THERE ARE SIGNIFICANT CHANGES. 953 00:44:36,270 --> 00:44:40,408 SAME IS TRUE IF YOU TAKE IN 954 00:44:40,408 --> 00:44:42,510 FOOD, YOU EXERCISE OR ANYTHING 955 00:44:42,510 --> 00:44:50,051 ELSE AND IT REACHES A STEADY 956 00:44:50,051 --> 00:44:54,522 STATE AFTER. 957 00:44:54,522 --> 00:44:57,225 AND THERE'S INTAKE OF DRUGS OR 958 00:44:57,225 --> 00:44:59,861 SUPPLEMENTS AND ALSO THE GUT 959 00:44:59,861 --> 00:45:01,829 BIOMEDICAL COMPOSITION. 960 00:45:01,829 --> 00:45:03,765 THOSE ARE ONLY A FEW EXAMPLES 961 00:45:03,765 --> 00:45:06,734 AND SHOW THE DYNAMIC READ OF 962 00:45:06,734 --> 00:45:17,045 HUMAN PHYSIOLOGY. 963 00:45:18,346 --> 00:45:19,781 AND THERE'S DIFFERENT PHENOTYPES 964 00:45:19,781 --> 00:45:23,751 AND WE SEE A FEW METABOLITES ARE 965 00:45:23,751 --> 00:45:25,853 DISEASE SPECIFIC ALONE WHEREAS 966 00:45:25,853 --> 00:45:27,922 MANY METABOLITES HAVE MANY 967 00:45:27,922 --> 00:45:33,261 DIFFERENT DISEASES AND THIS 968 00:45:33,261 --> 00:45:34,962 STAND TO REASON BECAUSE THEY 969 00:45:34,962 --> 00:45:36,998 COME WITH CHRONIC INFLAMMATION. 970 00:45:36,998 --> 00:45:38,733 WE'LL SEE INFLAMMATORY MARKERS 971 00:45:38,733 --> 00:45:40,701 POPPING UP FOR EACH AND EVERY 972 00:45:40,701 --> 00:45:41,335 ONE OF THEM. 973 00:45:41,335 --> 00:45:42,737 WHAT IS ALSO IMPORTANT IS MANY 974 00:45:42,737 --> 00:45:45,840 OF THE CHRONIC CONDITIONS THAT 975 00:45:45,840 --> 00:45:53,281 ARE OBSERVED IN PATIENTS WITH 976 00:45:53,281 --> 00:45:54,582 COGNITIVE IMPAIRMENT YOU HAVE 977 00:45:54,582 --> 00:45:57,251 CARDIOVASCULAR DISEASE AND 978 00:45:57,251 --> 00:45:57,718 HYPERTENSION. 979 00:45:57,718 --> 00:46:00,054 THE MISSION OF OUR CONSORTIUM 980 00:46:00,054 --> 00:46:01,789 WAS TO MAP OUT THE ALZHEIMER'S 981 00:46:01,789 --> 00:46:02,390 DISEASE METABOLOME. 982 00:46:02,390 --> 00:46:03,791 WHAT WE HAVE DONE IN THE LAST 983 00:46:03,791 --> 00:46:05,927 DECADE OR SO WAS TO GENERATE 984 00:46:05,927 --> 00:46:10,731 MORE THAN 60,000 METABOLOMIC 985 00:46:10,731 --> 00:46:14,068 PROFILES UP ALZHEIMER'S DISEASE 986 00:46:14,068 --> 00:46:16,370 STUDY IN BLOOD BRAIN AND MOUSE 987 00:46:16,370 --> 00:46:17,705 MODELS WITH ALZHEIMER'S DISEASE 988 00:46:17,705 --> 00:46:20,441 AND WE HAVE BEEN USING DIFFERENT 989 00:46:20,441 --> 00:46:21,776 TECHNOLOGIES THERE TO IDENTIFY 990 00:46:21,776 --> 00:46:22,677 THOSE PATHWAYS THAT ARE RELEVANT 991 00:46:22,677 --> 00:46:26,114 TO ALZHEIMER'S DISEASE. 992 00:46:26,114 --> 00:46:27,849 IN ADDITION TO JUST GENERATING 993 00:46:27,849 --> 00:46:29,984 THE DATA AND MAKING IT AVAILABLE 994 00:46:29,984 --> 00:46:33,821 WE HAVE INVESTED A LOT OF EFFORT 995 00:46:33,821 --> 00:46:34,956 INTO TECHNOLOGY STANDARDIZATION 996 00:46:34,956 --> 00:46:37,758 INCLUDING QUALITY CONTROL 997 00:46:37,758 --> 00:46:39,827 PROCEDURES AND WE ALSO DID 998 00:46:39,827 --> 00:46:41,095 CROSS-PLATFORM COMPARISONS TO 999 00:46:41,095 --> 00:46:42,029 IDENTIFY THOSE THAT GIVE THE 1000 00:46:42,029 --> 00:46:43,865 MOST ROBUST DATA AND HAVE 1001 00:46:43,865 --> 00:46:46,801 DESCRIBED ALL OF THIS IN 1002 00:46:46,801 --> 00:46:49,637 ADDITION TO MAKING THE METHODS 1003 00:46:49,637 --> 00:46:51,372 AVAILABLE AND OUR METHOD KEEP 1004 00:46:51,372 --> 00:46:57,445 EVOLVING AS WE LEARN MORE SO WE 1005 00:46:57,445 --> 00:46:59,380 CONTINUE TO CALL FOR PROCESSING 1006 00:46:59,380 --> 00:47:02,450 ANALYSIS UP STUDY WE PUBLISH. 1007 00:47:02,450 --> 00:47:05,553 NOW, IF WE LOOK AT THE 1008 00:47:05,553 --> 00:47:06,454 METABOLITE ASSOCIATIONS WE SEE 1009 00:47:06,454 --> 00:47:08,556 FOR ALZHEIMER'S DISEASE IN BLOOD 1010 00:47:08,556 --> 00:47:14,729 AND BRAIN ON A PATHWAY WE SEE 1011 00:47:14,729 --> 00:47:16,931 INFLAMMATION, OXIDATIVE STRESS, 1012 00:47:16,931 --> 00:47:20,001 CHOLESTEROL METABOLISM AND 1013 00:47:20,001 --> 00:47:25,039 COMPLEX LIPID METABOLISM AND 1014 00:47:25,039 --> 00:47:27,041 LOOKING AT THE SINGLE METABOLITE 1015 00:47:27,041 --> 00:47:28,075 LEVER SHOWN IN THE DIAGRAM IN 1016 00:47:28,075 --> 00:47:30,011 THE MIDDLE THAT IS COMING FROM 1017 00:47:30,011 --> 00:47:32,713 THE COHORT WHERE WE HAVE HAIR, 1018 00:47:32,713 --> 00:47:38,286 BLOOD AND BRAIN SAMPLES, WE SEE 1019 00:47:38,286 --> 00:47:42,190 LESS THAN 20% OF THE METABOLITES 1020 00:47:42,190 --> 00:47:42,823 SHOW CONSISTENT ASSOCIATIONS 1021 00:47:42,823 --> 00:47:44,392 ACROSS COMPARTMENTS. 1022 00:47:44,392 --> 00:47:46,761 AT THE SINGLE METABOLITE LEVEL 1023 00:47:46,761 --> 00:47:48,329 THESE ARE MORE COMPLEX. 1024 00:47:48,329 --> 00:47:50,731 THIS IS ALSO TRUE IF YOU COMPARE 1025 00:47:50,731 --> 00:47:53,267 THE RESULTS WE GET FROM BLOOD 1026 00:47:53,267 --> 00:47:54,135 METABOLOMICS FROM ONE COHORT 1027 00:47:54,135 --> 00:47:55,469 COMPARED TO ANOTHER. 1028 00:47:55,469 --> 00:47:58,172 WE WERE ASKING OURSELVES WHAT 1029 00:47:58,172 --> 00:48:00,274 MIGHT CONTRIBUTE TO THE 1030 00:48:00,274 --> 00:48:03,644 HETEROGENEITY WE'RE SEEING. 1031 00:48:03,644 --> 00:48:06,080 WE INVESTIGATED IF THIS COULD BE 1032 00:48:06,080 --> 00:48:10,718 LINKED TO DISEASE HETEROGENEITY. 1033 00:48:10,718 --> 00:48:14,522 WE INVESTIGATED TWO AND LOOKED 1034 00:48:14,522 --> 00:48:17,758 IF THE METABOLITE ASSOCIATIONS 1035 00:48:17,758 --> 00:48:18,726 WITH ALZHEIMER'S DISEASE WE 1036 00:48:18,726 --> 00:48:21,996 OBSERVED AND THE MAJORITY OF 1037 00:48:21,996 --> 00:48:24,765 ASSOCIATIONS WERE DIFFERENT. 1038 00:48:24,765 --> 00:48:26,500 HOW CAN WE USE IT TO COME UP 1039 00:48:26,500 --> 00:48:28,402 WITH SOMETHING THAT COULD BE 1040 00:48:28,402 --> 00:48:32,640 USED AS A BIOMARKER IN 1041 00:48:32,640 --> 00:48:33,641 ALZHEIMER'S DISEASE AND I'LL 1042 00:48:33,641 --> 00:48:39,547 GIVE ONE EXAMPLE. 1043 00:48:39,547 --> 00:48:46,787 HERE WE HYPOTHESIZED CAPTURING 1044 00:48:46,787 --> 00:48:47,922 HETEROGENEITY AND USING PRIOR 1045 00:48:47,922 --> 00:48:50,725 KNOWLEDGE USING A CLASS OF 1046 00:48:50,725 --> 00:48:54,729 METABOLITES THAT ARE ESTABLISHED 1047 00:48:54,729 --> 00:48:56,731 MARKERS FOR MITOCHONDRIA AND 1048 00:48:56,731 --> 00:49:02,737 THOSE METABOLITES ARE MEDIATORS 1049 00:49:02,737 --> 00:49:04,672 OF THE CYCLE TRANSPORTED IN AND 1050 00:49:04,672 --> 00:49:09,543 OUT OF MITOCHONDRIA AND 1051 00:49:09,543 --> 00:49:11,245 BIOMARKERS FOR COMPLEX 1052 00:49:11,245 --> 00:49:12,780 CONDITIONS LIKE TYPE II DIABETES 1053 00:49:12,780 --> 00:49:13,481 AND ALZHEIMER'S DISEASE. 1054 00:49:13,481 --> 00:49:19,086 IN ADDITION THEY'RE IN ROUTINELY 1055 00:49:19,086 --> 00:49:22,823 USED TO DETECT ERRORS AND SO 1056 00:49:22,823 --> 00:49:25,960 AREN'T CLINICAL ASSAYS AVAILABLE 1057 00:49:25,960 --> 00:49:27,061 AND THERE'S A STRONG COMPLEX 1058 00:49:27,061 --> 00:49:29,130 COMPONENT TO THE METABOLITES 1059 00:49:29,130 --> 00:49:32,333 WHICH ALLOW US TO INVESTIGATE 1060 00:49:32,333 --> 00:49:33,801 HOW MUCH OF THE DYSREGULATION IN 1061 00:49:33,801 --> 00:49:35,870 THIS PARTICULAR PATHWAY IS 1062 00:49:35,870 --> 00:49:37,271 LINKED TO GENETICS AND 1063 00:49:37,271 --> 00:49:39,740 MODIFIABLE FACTORS. 1064 00:49:39,740 --> 00:49:44,178 WHAT WE DID WAS WE USED FASTING 1065 00:49:44,178 --> 00:49:54,555 SERUM LEVELS OF 23 L-CARNITINE 1066 00:49:54,555 --> 00:49:56,123 AND THEN PERFORMED 1067 00:49:56,123 --> 00:49:57,692 IDENTIFICATION AND THAT SHOWED 1068 00:49:57,692 --> 00:49:59,694 THESE METABOLITES CLUSTER 1069 00:49:59,694 --> 00:50:02,463 PARTICIPANTS INTO GROUPS OF RISK 1070 00:50:02,463 --> 00:50:04,265 AND RESILIENCE TO ALZHEIMER'S 1071 00:50:04,265 --> 00:50:04,765 DISEASE. 1072 00:50:04,765 --> 00:50:06,300 WE SAW GENETIC EFFECTS TO 1073 00:50:06,300 --> 00:50:10,104 IMPAIRMENT OF THE TCA CYCLE LATE 1074 00:50:10,104 --> 00:50:11,772 IN THE DISEASE AND THE GENETIC 1075 00:50:11,772 --> 00:50:13,908 MARKERS CAN BE USED FOR SUB 1076 00:50:13,908 --> 00:50:14,975 STRATIFICATION AND MODIFIABLE 1077 00:50:14,975 --> 00:50:17,345 EFFECTS POINT TO A KEY ROLE OF 1078 00:50:17,345 --> 00:50:19,647 BETTER OXIDATION THAT MAY BE 1079 00:50:19,647 --> 00:50:20,915 MODIFIED FOR INSTANCE WITH 1080 00:50:20,915 --> 00:50:24,852 THERAPEUTIC INTERVENTIONS AND 1081 00:50:24,852 --> 00:50:26,721 NON THERMALOGIC INTERVENTIONS 1082 00:50:26,721 --> 00:50:30,391 AND WANTED TO COME UP WITH A 1083 00:50:30,391 --> 00:50:32,193 COMPOSITE MARKER AND CAME UP 1084 00:50:32,193 --> 00:50:34,729 WITH A FITNESS METRIC OR AGING 1085 00:50:34,729 --> 00:50:37,565 CLOCK DERIVED IN A HEALTHY 1086 00:50:37,565 --> 00:50:39,600 POPULATION-BASED COHORT AND 1087 00:50:39,600 --> 00:50:43,938 TRANSFERRED WHICH SHOWED US THIS 1088 00:50:43,938 --> 00:50:45,740 CORE WAS FOLLOWING THE 1089 00:50:45,740 --> 00:50:47,608 CLUSTERING STRUCTURE WE OBSERVED 1090 00:50:47,608 --> 00:50:51,812 AND ALSO ASSOCIATED 1091 00:50:51,812 --> 00:50:53,514 CROSS-SECTIONALLY WITH 1092 00:50:53,514 --> 00:50:55,850 BIOMARKERS INCLUDING ENERGETIC 1093 00:50:55,850 --> 00:50:57,885 STATUS IN THE BRAIN AFTER A PET 1094 00:50:57,885 --> 00:51:01,021 AND PREDICTIVE FOR FUTURE 1095 00:51:01,021 --> 00:51:07,395 COGNITIVE PROJECTIONS. 1096 00:51:07,395 --> 00:51:09,330 IN ORDER TO ESTIMATE WE 1097 00:51:09,330 --> 00:51:14,468 CONDUCTED A CLINICAL TRIAL USING 1098 00:51:14,468 --> 00:51:18,706 THE MOST EXTREME FIT QUARTILE OF 1099 00:51:18,706 --> 00:51:20,941 INDIVIDUALS AS A TREATMENT GROUP 1100 00:51:20,941 --> 00:51:24,612 AND CONTROL GROUP WERE THOSE 1101 00:51:24,612 --> 00:51:27,381 LEAST FIT AND THEN LOOKED AT HOW 1102 00:51:27,381 --> 00:51:29,383 THE TWO GROUPS ARE DIFFERENT 1103 00:51:29,383 --> 00:51:30,317 AFTER 18 MONTHS. 1104 00:51:30,317 --> 00:51:35,890 WHAT WE OBSERVED THERE IS WE GET 1105 00:51:35,890 --> 00:51:38,726 TO ESTIMATE WHAT WAS PUBLISHED 1106 00:51:38,726 --> 00:51:39,660 IN THE TRIAL. 1107 00:51:39,660 --> 00:51:42,596 AND WHAT IS ALSO NOTEWORTHY HERE 1108 00:51:42,596 --> 00:51:44,932 IS WE HAVE MUCH LESS IN OUR 1109 00:51:44,932 --> 00:51:45,166 STUDIES. 1110 00:51:45,166 --> 00:51:47,902 LESS THAN 200 INDIVIDUALS PER 1111 00:51:47,902 --> 00:51:51,972 ARM OF THE SIMULATED TRIAL AND 1112 00:51:51,972 --> 00:51:53,941 THE POWER CALCULATION INDICATED 1113 00:51:53,941 --> 00:51:55,209 WE NEED MORE THAN 800 AND THE 1114 00:51:55,209 --> 00:51:59,146 TRIAL HAD MORE THAN 800 1115 00:51:59,146 --> 00:52:00,614 INDIVIDUALS PER TREATMENT ARM. 1116 00:52:00,614 --> 00:52:02,716 IN ADDITION WE WANTED TO SEE IF 1117 00:52:02,716 --> 00:52:03,984 THERE ARE RISK FACTORS THAT 1118 00:52:03,984 --> 00:52:05,052 INFLUENCE POTENTIAL TREATMENT 1119 00:52:05,052 --> 00:52:06,053 BENEFIT IF YOU WOULD FIND A 1120 00:52:06,053 --> 00:52:06,720 TREATMENT THAT ACTS ON THE 1121 00:52:06,720 --> 00:52:09,089 SCORE. 1122 00:52:09,089 --> 00:52:11,158 WHAT WE SAW THERE IS WHILE APOE 1123 00:52:11,158 --> 00:52:15,696 4 HAD NO ROLE UP THIS, WE SAW 1124 00:52:15,696 --> 00:52:17,531 ACTUALLY FEMALES WOULD BENEFIT 1125 00:52:17,531 --> 00:52:20,935 MUCH MORE FROM MODULATING BIO 1126 00:52:20,935 --> 00:52:22,736 ENERGETIC AGE BY A FACTOR OF 1127 00:52:22,736 --> 00:52:27,575 ALMOST 2 THAN MALES IN CONTRAST 1128 00:52:27,575 --> 00:52:29,844 TO RECENT PUBLICATIONS SHOWED 1129 00:52:29,844 --> 00:52:33,547 FEMALES HAD MUCH LESS OR NO 1130 00:52:33,547 --> 00:52:33,848 BENEFIT. 1131 00:52:33,848 --> 00:52:36,183 SO WHAT I TRIED TO CONVEY IN THE 1132 00:52:36,183 --> 00:52:38,719 TALK IS THE BLOOD METABOLOME IS 1133 00:52:38,719 --> 00:52:41,889 A HUMAN PHYSIOLOGY THAT 1134 00:52:41,889 --> 00:52:45,993 NEVERTHELESS PROVIDERS ROBUST 1135 00:52:45,993 --> 00:52:49,930 MARKERS FOR HUMAN DISEASE 1136 00:52:49,930 --> 00:52:50,564 INCLUDING ALZHEIMER'S DISEASE 1137 00:52:50,564 --> 00:52:53,501 AND RESILIENCE AND THE TARGETING 1138 00:52:53,501 --> 00:52:55,836 SUCH METABOLIC ASPECTS LIKE THE 1139 00:52:55,836 --> 00:52:58,672 CAPACITY WITH PHARMACOLOGIC 1140 00:52:58,672 --> 00:53:02,009 INTERVENTIONS CAN BE A PROMISING 1141 00:53:02,009 --> 00:53:02,776 TREATMENT STRATEGY FOR 1142 00:53:02,776 --> 00:53:04,411 ALZHEIMER'S DISEASE AND SIMILAR 1143 00:53:04,411 --> 00:53:07,248 COMPOSITE MEASURES LIKE THIS FOR 1144 00:53:07,248 --> 00:53:08,182 OTHER PATHWAYS FOR ALZHEIMER'S 1145 00:53:08,182 --> 00:53:09,416 DISEASE NOT ONLY HAVE THE 1146 00:53:09,416 --> 00:53:12,152 POTENTIAL AS PRECISION MEDICINE 1147 00:53:12,152 --> 00:53:14,255 BIOMARKERS BUT CAN ACCELERATE 1148 00:53:14,255 --> 00:53:16,857 CLINICAL TRIALS BECAUSE OF THE 1149 00:53:16,857 --> 00:53:19,493 DYNAMIC NATURE OF THE METABOLOME 1150 00:53:19,493 --> 00:53:20,561 AND IDENTIFY NOVEL THERAPIES FOR 1151 00:53:20,561 --> 00:53:20,995 ALZHEIMER'S DISEASE. 1152 00:53:20,995 --> 00:53:31,171 THANK YOU. 1153 00:53:32,706 --> 00:53:34,141 >> NEXT IS ERIK JOHNSON FROM 1154 00:53:34,141 --> 00:53:34,542 EMORY UNIVERSITY. 1155 00:53:34,542 --> 00:53:44,618 THANK YOU. 1156 00:53:44,618 --> 00:53:47,354 >> THANK YOU FOR SETTING UP MY 1157 00:53:47,354 --> 00:53:48,522 PRESENTATION SO NICELY. 1158 00:53:48,522 --> 00:53:50,024 I'LL TALK ABOUT BIOMARKERS FROM 1159 00:53:50,024 --> 00:53:52,459 A PROTEOMIC ANGLE. 1160 00:53:52,459 --> 00:53:53,894 I'LL START WITH WORK WE DID A 1161 00:53:53,894 --> 00:53:55,229 FEW YEARS AGO IN BRAIN. 1162 00:53:55,229 --> 00:54:00,534 WE LOOKED AT THE PROTEOME IN THE 1163 00:54:00,534 --> 00:54:04,104 ROSS MAP AND COHORT ACROSS THE 1164 00:54:04,104 --> 00:54:07,007 SPECTRUM OF ALZHEIMER'S DISEASE 1165 00:54:07,007 --> 00:54:12,680 BY MASS SPECTOMETRY AND WE USED 1166 00:54:12,680 --> 00:54:14,782 TMTMS TO MEASURE OVER 1500 1167 00:54:14,782 --> 00:54:17,217 PROTEEPZ AND OVER 500 INDIVIDUAL 1168 00:54:17,217 --> 00:54:17,451 TISSUES. 1169 00:54:17,451 --> 00:54:18,719 THAT'S A VERY LARGE SET OF DATA 1170 00:54:18,719 --> 00:54:20,654 AND THE WAY WE TRY TO INTERPRET 1171 00:54:20,654 --> 00:54:23,223 THAT TO UNDERSTAND THE DISEASE 1172 00:54:23,223 --> 00:54:26,527 WE USE A PROTEIN COEXPRESSION 1173 00:54:26,527 --> 00:54:27,561 THAT CLUSTERS PROTEINS INTO 1174 00:54:27,561 --> 00:54:29,430 GROUPS WE CALL MODULES. 1175 00:54:29,430 --> 00:54:32,199 AND YOU CAN ANNOTATE THEM THE 1176 00:54:32,199 --> 00:54:33,334 DIFFERENT GROUPS BY THEIR 1177 00:54:33,334 --> 00:54:35,936 PRIMARY BIOLOGICAL PROCESSES OR 1178 00:54:35,936 --> 00:54:36,637 ONCOLOGIES. 1179 00:54:36,637 --> 00:54:38,305 THAT IS WHAT IS SHOWN AROUND THE 1180 00:54:38,305 --> 00:54:39,974 CIRCLE IN THE SPOKES ON THE 1181 00:54:39,974 --> 00:54:42,009 OUTSIDE OF THE ONTOLOGY AND 1182 00:54:42,009 --> 00:54:42,610 DIFFERENT MODULES. 1183 00:54:42,610 --> 00:54:44,945 YOU CAN SEE A VERY DIVERSE SET 1184 00:54:44,945 --> 00:54:45,779 OF ONTOLOGIES HERE. 1185 00:54:45,779 --> 00:54:49,149 I WANT TO TALK ABOUT TWO OF THEM 1186 00:54:49,149 --> 00:54:52,553 PARTICULARLY TODAY AND THAT IS 1187 00:54:52,553 --> 00:54:57,257 THE M42 MODULE AND ALSO THE M7 1188 00:54:57,257 --> 00:54:59,259 SIGNALLING AND METABOLISM 1189 00:54:59,259 --> 00:54:59,526 MODULE. 1190 00:54:59,526 --> 00:55:01,829 THE REASON IS THIS MODULE WE 1191 00:55:01,829 --> 00:55:04,832 IDENTIFIED WAS ONE WITH THE 1192 00:55:04,832 --> 00:55:05,833 STRONGEST CORRELATION TO 1193 00:55:05,833 --> 00:55:06,700 ALZHEIMER'S DISEASE PATHOLOGY IN 1194 00:55:06,700 --> 00:55:09,036 THE BRAIN. 1195 00:55:09,036 --> 00:55:14,341 AND THE MAP KINASE MODULE HAD 1196 00:55:14,341 --> 00:55:16,477 THE STRONGEST CORRELATION TO 1197 00:55:16,477 --> 00:55:16,910 FUNCTION. 1198 00:55:16,910 --> 00:55:18,712 IT WASN'T LARGE BUT THEY HAD A 1199 00:55:18,712 --> 00:55:19,980 COLLECTION OF PROTEINS THAT 1200 00:55:19,980 --> 00:55:22,116 SEEMED TO BE HIGHLY ASSOCIATED 1201 00:55:22,116 --> 00:55:25,152 WITH AMYLOID BETA DEPOSITION IN 1202 00:55:25,152 --> 00:55:27,187 THE BRAIN SHOWN ON THE LEFT. 1203 00:55:27,187 --> 00:55:30,724 AND THEHISTO CHEMISTRY HAS BEEN 1204 00:55:30,724 --> 00:55:33,594 PERFORMED BY A NUMBER OF GROUPS 1205 00:55:33,594 --> 00:55:34,728 DEMONSTRATING THIS. 1206 00:55:34,728 --> 00:55:38,732 ONE PROTEIN WAS FROM A MODULE 1207 00:55:38,732 --> 00:55:40,634 THAT STANDS FOR SPARK RELATED 1208 00:55:40,634 --> 00:55:42,703 MODULE PROTEIN 1. 1209 00:55:42,703 --> 00:55:44,304 AN EXTRA CELLULAR MATRIX 1210 00:55:44,304 --> 00:55:44,738 PROTEIN. 1211 00:55:44,738 --> 00:55:46,006 IT'S NOT SOMETHING WE TYPICALLY 1212 00:55:46,006 --> 00:55:48,509 ASSOCIATE OR HAVE KNOWN IN THE 1213 00:55:48,509 --> 00:55:51,378 PAST TO BE ASSOCIATED WITH 1214 00:55:51,378 --> 00:55:51,845 ALZHEIMER'S. 1215 00:55:51,845 --> 00:55:54,848 IT'S A MORPHOGENIC PROTEIN 1216 00:55:54,848 --> 00:55:57,084 SIGNALLING AND INVOLVES THE 1217 00:55:57,084 --> 00:56:00,988 SIGNALLING PATHWAY AND PROMOTES 1218 00:56:00,988 --> 00:56:04,124 ANGIOGENESIS AND A HEPARAN 1219 00:56:04,124 --> 00:56:04,858 BINDING PROTEIN AS WELL AS 1220 00:56:04,858 --> 00:56:06,160 OTHERS IN THE MODULE. 1221 00:56:06,160 --> 00:56:09,396 IF YOU LOOK AT BIO FLUIDS IN 1222 00:56:09,396 --> 00:56:10,998 ALZHEIMER'S DISEASE BY MULTIPLE 1223 00:56:10,998 --> 00:56:14,702 TECHNIQUES YOU CAN SEE IT'S 1224 00:56:14,702 --> 00:56:15,602 INCREASED. 1225 00:56:15,602 --> 00:56:18,672 CSF AND PLASMA AND SEEMS TO BE 1226 00:56:18,672 --> 00:56:19,707 RATHER SPECIFIC FOR ALZHEIMER'S 1227 00:56:19,707 --> 00:56:21,408 DISEASE WHICH MAKES SENSE 1228 00:56:21,408 --> 00:56:23,310 BECAUSE IT'S ASSOCIATED WITH 1229 00:56:23,310 --> 00:56:26,413 AMYLOID BETA. 1230 00:56:26,413 --> 00:56:28,982 WE'VE LOOKED AT ALS AND 1231 00:56:28,982 --> 00:56:30,584 PARKINSON'S DISEASE TO SEE THE 1232 00:56:30,584 --> 00:56:31,285 SPECIFICITY. 1233 00:56:31,285 --> 00:56:32,920 NOW, WE'RE INTERESTED IN LOOKING 1234 00:56:32,920 --> 00:56:35,589 AT HOW THIS PROTEIN CHANGED OVER 1235 00:56:35,589 --> 00:56:37,224 TIME AND ONE WAY YOU CAN DO THAT 1236 00:56:37,224 --> 00:56:46,066 IS TO LOOK IN A COHORT LIKE THE 1237 00:56:46,066 --> 00:56:50,404 THIS COHORT THE POWER OF ADAD IS 1238 00:56:50,404 --> 00:56:52,005 YOU KNOW WITH FAIRLY GOOD 1239 00:56:52,005 --> 00:56:53,173 PRECISION WHEN PEOPLE WILL 1240 00:56:53,173 --> 00:56:58,112 DEVELOP THE DISEASE AND PUT THIS 1241 00:56:58,112 --> 00:57:02,316 INTO A LONGITUDINAL CONTEXT AND 1242 00:57:02,316 --> 00:57:03,517 I'M SHOWING TWO MEASURES HERE. 1243 00:57:03,517 --> 00:57:07,721 FIRST IS THE A BETA 42 OVER 40 1244 00:57:07,721 --> 00:57:11,992 RATIO A GOOD MARKER OF PLAQUE 1245 00:57:11,992 --> 00:57:16,363 DEPOSITION AND THE PEOPLE WITH 1246 00:57:16,363 --> 00:57:19,199 AUTOSOMAL MUTATION CARRIERS HAVE 1247 00:57:19,199 --> 00:57:20,634 INCREASED LEVELS EARLY ON IN 1248 00:57:20,634 --> 00:57:23,070 LIFE BECAUSE THEY PRODUCE MORE 1249 00:57:23,070 --> 00:57:25,305 42 COMPARED TO 40 AND AS THEY 1250 00:57:25,305 --> 00:57:28,342 DEVELOP PLAQUE THAT DECREASES. 1251 00:57:28,342 --> 00:57:30,577 IF YOU LOOK AT WHEN THE CHANGE 1252 00:57:30,577 --> 00:57:33,547 OCCURS COMPARED TO A CONTROL OR 1253 00:57:33,547 --> 00:57:34,915 NON-CARRIER, THAT'S ABOUT 18 1254 00:57:34,915 --> 00:57:39,353 YEARS PRIOR TO SYMPTOM ONSET 1255 00:57:39,353 --> 00:57:42,589 COMPARED TO ONSET OF 0. 1256 00:57:42,589 --> 00:57:44,291 THAT STARTS TO INCREASE IN 1257 00:57:44,291 --> 00:57:48,462 CARRIERS EARLY AS THE A BETA 42 1258 00:57:48,462 --> 00:57:50,631 TO 40 IS CHANGES AND IF YOU LOOK 1259 00:57:50,631 --> 00:57:52,566 AT THE ABSOLUTE CHANGE THAT 1260 00:57:52,566 --> 00:57:54,701 OCCURS ABOUT 29 YEARS PRIOR TO 1261 00:57:54,701 --> 00:57:57,704 SYMPTOM ONSET. 1262 00:57:57,704 --> 00:57:59,873 AND SO IF WE THEN PUT THIS INTO 1263 00:57:59,873 --> 00:58:01,208 THE BROADER CONTEXT OF SOME OF 1264 00:58:01,208 --> 00:58:02,709 THE OTHER PROTEINS WE MEASURED 1265 00:58:02,709 --> 00:58:06,713 IN THE COHORT YOU CAN SEE THE 1266 00:58:06,713 --> 00:58:09,950 PROTEINS ARE CHANGING VERY EARLY 1267 00:58:09,950 --> 00:58:13,954 ALONG WITH A BETA 42 OVER 40. 1268 00:58:13,954 --> 00:58:17,224 EARLIER THAN P TAU 217 AND CSF 1269 00:58:17,224 --> 00:58:20,127 THE RED IS SHOWING THE INCREASE 1270 00:58:20,127 --> 00:58:20,928 UP CARRIERS. 1271 00:58:20,928 --> 00:58:24,832 YOU CAN SEE IT'S INCREASING EVEN 1272 00:58:24,832 --> 00:58:26,733 EARLIER THAN P TAU 217 AND USE 1273 00:58:26,733 --> 00:58:28,335 OTHER MARKERS WE ASSOCIATE WITH 1274 00:58:28,335 --> 00:58:30,637 HOW THEY'RE RELATED TO THE BRAIN 1275 00:58:30,637 --> 00:58:32,206 MODULES WE MEASURE TRANSLATING 1276 00:58:32,206 --> 00:58:33,674 THE BRAIN TO THE CSF. 1277 00:58:33,674 --> 00:58:36,944 THESE ARE PROTEINS WE MAP TO THE 1278 00:58:36,944 --> 00:58:38,278 BRAIN MODULES TO UNDERSTAND OVER 1279 00:58:38,278 --> 00:58:40,581 TIME HOW THE BRAIN IS CHANGING 1280 00:58:40,581 --> 00:58:43,250 IN THE EVOLUTION OF AUTOSOMAL 1281 00:58:43,250 --> 00:58:43,684 ALZHEIMER'S DISEASE. 1282 00:58:43,684 --> 00:58:46,520 WE SEE EARLY CHANGES IN A BETA 1283 00:58:46,520 --> 00:58:49,356 PLAQUE FOLLOWED BY SYNAPTIC 1284 00:58:49,356 --> 00:58:52,226 CHANGES IN GLUCOSE METABOLISM 1285 00:58:52,226 --> 00:58:54,528 AND RESPONSE AND INTEGRITY AND 1286 00:58:54,528 --> 00:58:57,531 IMMUNE CHANGES ASSOCIATED WITH 1287 00:58:57,531 --> 00:58:59,967 COGNITIVE DECLINE AND CORTICAL 1288 00:58:59,967 --> 00:59:01,768 ATROPHY AND METABOLISM CHANGES. 1289 00:59:01,768 --> 00:59:03,537 PUTTING THESE BIOMARKERS THEN 1290 00:59:03,537 --> 00:59:06,707 INTO CONTEXT TO UNDERSTAND THE 1291 00:59:06,707 --> 00:59:09,076 NATURAL HISTORY OF AUTOSOMAL 1292 00:59:09,076 --> 00:59:10,143 DOMINANCE. 1293 00:59:10,143 --> 00:59:12,946 IT'S SUMMARIZED IN A FIGURE LIKE 1294 00:59:12,946 --> 00:59:14,715 THIS SEEING THE EARLY CHANGES 1295 00:59:14,715 --> 00:59:20,354 WITH A BETA PLAQUE AND FOLLOWED 1296 00:59:20,354 --> 00:59:24,291 BY METABOLISM THAT CHANGE OVER 1297 00:59:24,291 --> 00:59:26,894 TIME AND PATTERNS. 1298 00:59:26,894 --> 00:59:30,731 GETTING BACK TO SMOC1 WE THINK 1299 00:59:30,731 --> 00:59:35,602 THE PROTEINS ARE NOT INCIDENTAL 1300 00:59:35,602 --> 00:59:39,506 BIOMARKERS AND MAY BE GOOD 1301 00:59:39,506 --> 00:59:39,907 THERAPEUTICS. 1302 00:59:39,907 --> 00:59:44,544 I'M GOING TO SHOW YOU SOME NEW 1303 00:59:44,544 --> 00:59:46,246 DATA FROM THE COHORT WHERE WE 1304 00:59:46,246 --> 00:59:49,016 HAVE A PERSON WHO HAS SHOWN 1305 00:59:49,016 --> 00:59:51,685 EXTREME RESILIENCE TO THE 1306 00:59:51,685 --> 00:59:54,621 MUTATION THAT CAUSES ONE OF THE 1307 00:59:54,621 --> 00:59:58,292 MUTATIONS THAT CAUSES AUTOSOMAL 1308 00:59:58,292 --> 00:59:59,860 DOMINANCE AND NOW 20 YEARS PAST 1309 00:59:59,860 --> 01:00:02,729 WHEN WE EXPECTED THEM TO DEVELOP 1310 01:00:02,729 --> 01:00:04,331 THE DISEASE AND A CLEAR OUTLIER 1311 01:00:04,331 --> 01:00:06,700 FROM THE REST OF THE MUTATION 1312 01:00:06,700 --> 01:00:06,967 CARRIERS. 1313 01:00:06,967 --> 01:00:08,635 IF YOU LOOK AT THE AMOUNT OF 1314 01:00:08,635 --> 01:00:10,037 AMYLOID IN THIS INDIVIDUAL'S 1315 01:00:10,037 --> 01:00:11,471 BRAIN IT'S VERY HIGH. 1316 01:00:11,471 --> 01:00:14,441 HERE'S THE ESTIMATE HERE. 1317 01:00:14,441 --> 01:00:16,343 IN FACT THIS IT WILL BASICALLY 1318 01:00:16,343 --> 01:00:18,712 WHERE THE COHORT ENDS, 1319 01:00:18,712 --> 01:00:20,047 UNFORTUNATELY FOR THESE 1320 01:00:20,047 --> 01:00:22,282 INDIVIDUALS BUT HE'S AT THE TOP 1321 01:00:22,282 --> 01:00:25,919 OF THE ESTIMATE HERE AT 100% AND 1322 01:00:25,919 --> 01:00:27,888 BASICALLY DRIVING THE REST OF 1323 01:00:27,888 --> 01:00:28,789 THIS BECAUSE HE'S THE ONLY 1324 01:00:28,789 --> 01:00:30,023 PERSON OUT HERE. 1325 01:00:30,023 --> 01:00:36,096 IF YOU LOOK AT THE LEVELS OF 1326 01:00:36,096 --> 01:00:38,432 SMOC THEY'RE NOT THE SAME LEVEL 1327 01:00:38,432 --> 01:00:42,703 AS THE AMYLOID BETA. 1328 01:00:42,703 --> 01:00:51,144 IT'S SUGGESTIVE AND THIS COULD 1329 01:00:51,144 --> 01:00:53,480 BE AN MOLECULE IN THE 1330 01:00:53,480 --> 01:00:54,614 PATHOGENESIS OF THE DISEASE. 1331 01:00:54,614 --> 01:00:55,849 WE CAN THEN TAKE THE SAME 1332 01:00:55,849 --> 01:00:58,618 APPROACH WE'VE DONE IN BRAIN AND 1333 01:00:58,618 --> 01:01:02,189 APPLY IT TO CSF AND MEASURE 1334 01:01:02,189 --> 01:01:04,091 THOUSANDS OF PROTEINS IN THE CSF 1335 01:01:04,091 --> 01:01:06,727 AND HAVE DONE THIS IN A RECENT 1336 01:01:06,727 --> 01:01:13,300 STUDY USING TWO PROTEOMIC 1337 01:01:13,300 --> 01:01:14,401 PLATFORMS MASS SPEC AND BUILD 1338 01:01:14,401 --> 01:01:18,572 THE SAME TYPE OF NETWORKS AND 1339 01:01:18,572 --> 01:01:21,675 UNDERSTAND WHAT'S CHANGING IN 1340 01:01:21,675 --> 01:01:22,175 ALZHEIMER'S DISEASE. 1341 01:01:22,175 --> 01:01:23,176 TO HIGHLIGHT HERE WE CAN 1342 01:01:23,176 --> 01:01:25,612 IDENTIFY MODULES STRONGLY 1343 01:01:25,612 --> 01:01:29,182 ASSOCIATED WITH APOE 4 IN CSF. 1344 01:01:29,182 --> 01:01:32,319 THIS DETOXIFICATION OF THE 1345 01:01:32,319 --> 01:01:33,153 KINASE SIGNALLING AGAIN 1346 01:01:33,153 --> 01:01:38,725 METALATION WHICH IS SIMILAR TO 1347 01:01:38,725 --> 01:01:41,461 YOU BICK WIT INATION AND 1348 01:01:41,461 --> 01:01:46,299 ASSOCIATED WITH APOE 4 RAND CSF 1349 01:01:46,299 --> 01:01:52,305 AND WANTED TO FOCUS ON THE 1350 01:01:52,305 --> 01:01:54,207 GLYCOLYSIS MODULE. 1351 01:01:54,207 --> 01:01:56,243 THIS WAS RELATED TO COGNITIVE 1352 01:01:56,243 --> 01:01:59,246 FUNCTION IN CSF NOT JUST BRAIN 1353 01:01:59,246 --> 01:02:02,049 WE CAN OBSERVE AND SEE HOW IT'S 1354 01:02:02,049 --> 01:02:03,984 INCREASED IN ALZHEIMER'S DISEASE 1355 01:02:03,984 --> 01:02:07,354 COMPARED TO CONTROLS AND THIS IS 1356 01:02:07,354 --> 01:02:08,889 TRYING TO USE THIS IN A CLINICAL 1357 01:02:08,889 --> 01:02:13,794 TRIAL CONTEXT TO USE THIS CSF 1358 01:02:13,794 --> 01:02:16,563 PROTEOMIC ANALYSIS TO REALLY TRY 1359 01:02:16,563 --> 01:02:19,599 TO TRANSLATE THAT INTO POTENTIAL 1360 01:02:19,599 --> 01:02:21,568 BIOMARKERS AT A PROTEOMIC LEVEL 1361 01:02:21,568 --> 01:02:22,335 IN CSF. 1362 01:02:22,335 --> 01:02:25,105 THE WAY WE'RE THINKING OF DOING 1363 01:02:25,105 --> 01:02:27,207 THIS I'LL DESCRIBE BRIEFLY AN 1364 01:02:27,207 --> 01:02:29,843 EXAMPLE THE MEDICATION CALLED 1365 01:02:29,843 --> 01:02:36,583 ATAMO X ITINE APPROVED FOR 1366 01:02:36,583 --> 01:02:39,753 ATTENTION DEFICIT HYPER ACTIVITY 1367 01:02:39,753 --> 01:02:42,189 DISORDER MAINLY IN CHILDREN AND 1368 01:02:42,189 --> 01:02:44,491 NOREPINEPHRINE REUP TAKE 1369 01:02:44,491 --> 01:02:46,193 INHIBITOR AND IN ALZHEIMER'S 1370 01:02:46,193 --> 01:02:51,598 DISEASE ONCE OF THE EARLIEST 1371 01:02:51,598 --> 01:02:54,701 CHANGES IS LOCUS SER EELIUS AND 1372 01:02:54,701 --> 01:02:57,404 THERE'S PRE CLINICAL WORK THAT 1373 01:02:57,404 --> 01:02:58,905 SHOWED THIS COULD POTENTIALLY BE 1374 01:02:58,905 --> 01:03:02,342 A DISEASE MODIFYING PATHWAY 1375 01:03:02,342 --> 01:03:02,609 TARGETED. 1376 01:03:02,609 --> 01:03:07,814 SO THERE WAS A CLINICAL TRIAL AT 1377 01:03:07,814 --> 01:03:14,254 EMORY A SMALL ONE WHERE WE 1378 01:03:14,254 --> 01:03:16,323 TESTED THIS COMPOUND AND CROSS 1379 01:03:16,323 --> 01:03:26,766 OVER OF THE DESIGN TRIAL. 1380 01:03:27,467 --> 01:03:37,944 WE LOOKED AT AND IF WE LOOKED AT 1381 01:03:40,780 --> 01:03:41,882 A COMBINATION OF PROTEINS THAT 1382 01:03:41,882 --> 01:03:45,252 GAVE US A BETTER PREDICTION IN 1383 01:03:45,252 --> 01:03:46,720 TERMS OF A RATIO. 1384 01:03:46,720 --> 01:03:48,355 ILLUSTRATING THE PROTEOMIC 1385 01:03:48,355 --> 01:03:51,057 APPROACH AND TO WRAP UP I KNOW 1386 01:03:51,057 --> 01:03:54,127 I'M OUT OF TIME WE'LL DO WORK 1387 01:03:54,127 --> 01:03:57,564 HERE IN SPORADIC EARLY ONSET 1388 01:03:57,564 --> 01:03:58,231 ALZHEIMER'S DISEASE LOOKING AT 1389 01:03:58,231 --> 01:04:01,635 BRAIN CSF AND PLASMA. 1390 01:04:01,635 --> 01:04:03,203 WE'RE SEEING INTERESTING 1391 01:04:03,203 --> 01:04:04,905 FINDINGS IN EARLY ONSET COMPARED 1392 01:04:04,905 --> 01:04:06,706 TO OTHER TYPE OF ALZHEIMER'S 1393 01:04:06,706 --> 01:04:08,375 DISEASE FINALLY IN DOWN SYNDROME 1394 01:04:08,375 --> 01:04:09,409 WHICH HAS ALREADY BEEN TALKED 1395 01:04:09,409 --> 01:04:10,644 ABOUT AT THE CONFERENCE TO LOOK 1396 01:04:10,644 --> 01:04:13,647 AT THE PROTEOMIC CHANGES FOR 1397 01:04:13,647 --> 01:04:15,182 DOWN SYNDROME. 1398 01:04:15,182 --> 01:04:18,718 AND FINALLY THE GNPC IS AN 1399 01:04:18,718 --> 01:04:23,023 EFFORT YOU'LL HEAR ABOUT OVER 1400 01:04:23,023 --> 01:04:26,560 THE NEXT YEAR AND IT'S USING 1401 01:04:26,560 --> 01:04:29,529 COHORTS AROUND THE WORLD WITH 1402 01:04:29,529 --> 01:04:31,798 PLASMA-BASED PROTEOMICS TO 1403 01:04:31,798 --> 01:04:32,933 BETTER UNDERSTAND THE DISEASE 1404 01:04:32,933 --> 01:04:33,767 AND ITS BIOMARKERS. 1405 01:04:33,767 --> 01:04:34,100 MORE TO COME. 1406 01:04:34,100 --> 01:04:44,244 THANKS. 1407 01:04:49,849 --> 01:04:53,220 >> OUR NEXT SPEAKER IS ROB 1408 01:04:53,220 --> 01:04:54,387 RISSMAN FROM THE UNIVERSITY OF 1409 01:04:54,387 --> 01:04:56,022 SOUTHERN CLINICAL RESEARCH. 1410 01:04:56,022 --> 01:04:57,857 >> THANK YOU FOR THAT. 1411 01:04:57,857 --> 01:05:02,562 I WANT TO THANK ERIKA AND LAURIE 1412 01:05:02,562 --> 01:05:09,102 FOR INVITING ME AND HELPING ME 1413 01:05:09,102 --> 01:05:11,705 ASSEMBLE MY SLIDES. 1414 01:05:11,705 --> 01:05:14,708 I'LL TALK ABOUT ATNV BIOMARKERS 1415 01:05:14,708 --> 01:05:18,712 HOW TO USE IN BIOMARKER TO 1416 01:05:18,712 --> 01:05:23,650 INCREASE INCLUSIVITY IN CLINICAL 1417 01:05:23,650 --> 01:05:27,621 TRIALS. 1418 01:05:27,621 --> 01:05:32,492 AND THIS IS PROBABLY THE LARGEST 1419 01:05:32,492 --> 01:05:34,294 COHORT STUDY OF DIVERSE ETHNIC 1420 01:05:34,294 --> 01:05:35,862 GROUPS IN THE COUNTRY. 1421 01:05:35,862 --> 01:05:38,331 THUS FAR WE'VE COLLECTED A HUGE 1422 01:05:38,331 --> 01:05:39,566 AMOUNT OF DATA. 1423 01:05:39,566 --> 01:05:44,170 WE HAVE THOUSANDS OF PEOPLE FROM 1424 01:05:44,170 --> 01:05:45,772 DIFFERENT DIVERSE GROUPS A WIDE 1425 01:05:45,772 --> 01:05:47,707 VARIETY OF AGES. 1426 01:05:47,707 --> 01:05:50,377 ALL KIND OF BIO SPECIMENS AND 1427 01:05:50,377 --> 01:05:51,811 IMAGING SAMPLES WHICH ARE ALL 1428 01:05:51,811 --> 01:05:52,812 AVAILABLE FOR SHARING THROUGH A 1429 01:05:52,812 --> 01:05:54,648 DATA LINK YOU CAN SEE AT THE 1430 01:05:54,648 --> 01:05:55,749 BOTTOM THERE. 1431 01:05:55,749 --> 01:06:00,287 SO ONE VERY IMPORTANT PART ABOUT 1432 01:06:00,287 --> 01:06:02,422 THIS COHORT IS THE ABILITY TO 1433 01:06:02,422 --> 01:06:04,457 EXPAND DATA FROM NON-DIVERSE 1434 01:06:04,457 --> 01:06:06,726 COHORTS FROM SOME OF OUR 1435 01:06:06,726 --> 01:06:08,828 CLINICAL TRIALS TO BE ABLE TO 1436 01:06:08,828 --> 01:06:10,430 ESTABLISH CUT OFFS AND RANGES 1437 01:06:10,430 --> 01:06:13,033 THAT CAN BE POTENTIALLY USED TO 1438 01:06:13,033 --> 01:06:15,769 HELP THESE ETHNIC GROUPS GET 1439 01:06:15,769 --> 01:06:16,436 INTO CLINICAL TRIALS. 1440 01:06:16,436 --> 01:06:20,940 JUST AS AN EXAMPLE OF HOW THE 1441 01:06:20,940 --> 01:06:26,646 DATA CAN BE USED USING SOME 1442 01:06:26,646 --> 01:06:28,248 IMAGING STUFF. 1443 01:06:28,248 --> 01:06:30,283 AS WE ALL KNOW TAU IS VERY MUCH 1444 01:06:30,283 --> 01:06:32,485 RELATED TO CELL LOSS AND 1445 01:06:32,485 --> 01:06:35,922 COGNITIVE CHANGE IN NON-HISPANIC 1446 01:06:35,922 --> 01:06:36,156 WHITES. 1447 01:06:36,156 --> 01:06:36,756 WE'VE KNOWN THIS FOR A LONG 1448 01:06:36,756 --> 01:06:36,956 TIME. 1449 01:06:36,956 --> 01:06:38,958 IT'S NOT NECESSARILY THE CASE IN 1450 01:06:38,958 --> 01:06:40,927 ALL ETHNIC GROUPS. 1451 01:06:40,927 --> 01:06:43,496 INDEED IN HER STUDY SHE FOUND 1452 01:06:43,496 --> 01:06:45,065 THERE WAS SOMETHING ELSE DRIVING 1453 01:06:45,065 --> 01:06:46,066 COGNITIVE IMPAIRMENT THAT 1454 01:06:46,066 --> 01:06:46,700 DOESN'T SEEM TO BE TAU. 1455 01:06:46,700 --> 01:06:51,938 SO WITH THE ABILITY OF THIS 1456 01:06:51,938 --> 01:06:53,440 COHORT BEING SO SENSITIVE TO 1457 01:06:53,440 --> 01:06:57,477 DETECTION OF DIFFERENCES BETWEEN 1458 01:06:57,477 --> 01:06:58,345 ETHNIC GROUPS WE THOUGHT TO 1459 01:06:58,345 --> 01:07:01,548 LEVERAGE THIS AND UNDERSTAND HOW 1460 01:07:01,548 --> 01:07:04,551 TO USE THESE DEVELOPS TO 1461 01:07:04,551 --> 01:07:07,520 INCREASE CLINICAL TRIAL 1462 01:07:07,520 --> 01:07:07,821 RECRUITMENT. 1463 01:07:07,821 --> 01:07:09,255 AND AS AN EXAMPLE OF WHAT 1464 01:07:09,255 --> 01:07:12,392 HAPPENS WHEN YOU DON'T DO ANY 1465 01:07:12,392 --> 01:07:14,694 SPECIAL WORK YOU JUST BRING 1466 01:07:14,694 --> 01:07:17,263 PEOPLE IN, YOU TEST THEM 1467 01:07:17,263 --> 01:07:22,535 COGNITIVELY AND DO PET SCANS YOU 1468 01:07:22,535 --> 01:07:24,971 GET A HIGH LEVEL OF SCREEN AND 1469 01:07:24,971 --> 01:07:26,906 THIS IS WITHOUT PLASMA 1470 01:07:26,906 --> 01:07:28,174 SCREENING. 1471 01:07:28,174 --> 01:07:30,510 WE ALL HEARD A LOT ABOUT PLASMA 1472 01:07:30,510 --> 01:07:31,311 NOT ONLY IN THE LITERATURE BUT 1473 01:07:31,311 --> 01:07:33,480 IN THE CONFERENCE. 1474 01:07:33,480 --> 01:07:35,482 WE'RE TALKING ABOUT USING PLASMA 1475 01:07:35,482 --> 01:07:41,121 P TAU 217 OR A BETA 242/40 TO 1476 01:07:41,121 --> 01:07:44,224 UNDERSTAND HOW MUCH AMYLOID IS 1477 01:07:44,224 --> 01:07:46,426 IN SOMEONE'S BRAIN. 1478 01:07:46,426 --> 01:07:48,895 SCREEN FAIL IS VERY HIGH. 1479 01:07:48,895 --> 01:07:51,765 PART OF THE REASON THAT IS, IS 1480 01:07:51,765 --> 01:07:53,433 BECAUSE AND WE BRING PEOPLE IN 1481 01:07:53,433 --> 01:07:55,034 AND TAKE ALL COMERS. 1482 01:07:55,034 --> 01:07:56,269 WE DON'T DO SPECIAL PROCEDURES 1483 01:07:56,269 --> 01:07:59,572 TO SEE WHETHER OR NOT TO 1484 01:07:59,572 --> 01:07:59,839 PRESCREEN. 1485 01:07:59,839 --> 01:08:01,908 AGAIN BECAUSE WE HAVE DONE THIS 1486 01:08:01,908 --> 01:08:07,280 IN THE PAST ALL THESE TRIALS 1487 01:08:07,280 --> 01:08:12,852 SUCH AS A4 HAD A HIGH LEVEL OF 1488 01:08:12,852 --> 01:08:14,320 SCREEN YEARS AND TOOK ALMOST 1489 01:08:14,320 --> 01:08:18,725 FOUR YEARS TO TAKE THE TRIAL NO 1490 01:08:18,725 --> 01:08:21,895 WITH STANDING COVID BUT THE MAIN 1491 01:08:21,895 --> 01:08:24,364 CAUSE WAS DUE TO TWO NEGATIVE 1492 01:08:24,364 --> 01:08:25,565 PET SCANS. 1493 01:08:25,565 --> 01:08:27,834 WE WANT TO GET PEOPLE IN MORE 1494 01:08:27,834 --> 01:08:29,169 QUICKLY USING A PLASMA BIOMARKER 1495 01:08:29,169 --> 01:08:31,504 AND SEE HOW WE CAN IMPROVE THIS. 1496 01:08:31,504 --> 01:08:36,576 AND WE'RE USING THIS RIGHT NOW 1497 01:08:36,576 --> 01:08:47,086 IN THE HEAD TRIAL IT'S A NOT 1498 01:08:47,720 --> 01:08:49,889 ONLY TO REDUCE SCREENING TIME 1499 01:08:49,889 --> 01:08:52,125 AND BURDEN AND REDUCE INCLUSION 1500 01:08:52,125 --> 01:08:54,294 OF DIVERSE PARTICIPANTS TO GET 1501 01:08:54,294 --> 01:08:56,529 MORE THAN JUST NON-HISPANIC 1502 01:08:56,529 --> 01:08:57,630 WHITES INTO THE TRIALS IS THE 1503 01:08:57,630 --> 01:08:58,865 MAIN GOAL. 1504 01:08:58,865 --> 01:09:02,635 THIS IS HOW IT LOOKED. 1505 01:09:02,635 --> 01:09:05,705 AGAIN, THIS IS PREDOMINANTLY IN 1506 01:09:05,705 --> 01:09:07,640 NON-HISPANIC WHITES AND USING 1507 01:09:07,640 --> 01:09:08,308 PLASMA BIOMARKERS WE CAN DO WELL 1508 01:09:08,308 --> 01:09:11,478 AT PREDICTING AMYLOID PET. 1509 01:09:11,478 --> 01:09:15,348 YOU CAN SEE THE PTAU 217 RATIO 1510 01:09:15,348 --> 01:09:17,383 WITH MASS SPECTOMETRY. 1511 01:09:17,383 --> 01:09:20,887 YOU CAN SEE A HIGH LEVEL OF THIS 1512 01:09:20,887 --> 01:09:22,622 AND ABLE TO DETECT PEOPLE WITH 1513 01:09:22,622 --> 01:09:24,457 AMYLOID AND BRAIN. 1514 01:09:24,457 --> 01:09:28,361 WHEN WE COMBINE THAT WITH A BETA 1515 01:09:28,361 --> 01:09:30,296 42 AND 40 IT GOES HIGHER. 1516 01:09:30,296 --> 01:09:31,965 WE PRACTICALLY HAVE AN 1517 01:09:31,965 --> 01:09:32,365 IDENTIFICATION. 1518 01:09:32,365 --> 01:09:36,002 A TREMENDOUS TOOL TO GET PEOPLE 1519 01:09:36,002 --> 01:09:36,870 THROUGH QUICKLY INTO THE 1520 01:09:36,870 --> 01:09:38,304 SCREENING PROCESS AND GET THEM 1521 01:09:38,304 --> 01:09:39,706 HOPEFULLY TREATED. 1522 01:09:39,706 --> 01:09:40,907 BEING THIS IS A BLOOD BIOMARKER 1523 01:09:40,907 --> 01:09:42,275 YOU DON'T NECESSARILY HAVE TO GO 1524 01:09:42,275 --> 01:09:43,243 TO A CLINIC. 1525 01:09:43,243 --> 01:09:44,878 YOU CAN HAVE IT DONE REMOTELY 1526 01:09:44,878 --> 01:09:48,147 AND GO IT ALL KINDS OF PLACES 1527 01:09:48,147 --> 01:09:50,717 FOR IT, IT COULD BE SOMETHING TO 1528 01:09:50,717 --> 01:09:51,784 ATTRACT ETHNIC GROUPS AND 1529 01:09:51,784 --> 01:09:53,019 DIVERSE COMMUNITIES TO GET 1530 01:09:53,019 --> 01:09:53,686 INVOLVED IN TRIALS AND GET THE 1531 01:09:53,686 --> 01:09:57,957 HELP THEY NEED. 1532 01:09:57,957 --> 01:10:02,695 SO SURE ENOUGH WHEN WE USE 1533 01:10:02,695 --> 01:10:04,864 PLASMA PRESCREENING SEE IN THE 1534 01:10:04,864 --> 01:10:07,066 ORANGISH REDDISH LINE WE REDUCED 1535 01:10:07,066 --> 01:10:10,303 SCREEN FAILS DRAMATICALLY. 1536 01:10:10,303 --> 01:10:13,473 WE'RE UP PRACTICALLY LIKE 75 1537 01:10:13,473 --> 01:10:15,842 PLUS PERCENT SCREEN FAILS. 1538 01:10:15,842 --> 01:10:19,646 THAT'S OUTRAGEOUS NO WONDER A4 1539 01:10:19,646 --> 01:10:20,547 TOOK US 10 YEARS. 1540 01:10:20,547 --> 01:10:22,549 IT WASN'T JUST COVID. 1541 01:10:22,549 --> 01:10:25,084 WE'RE ABLE TO REALLY REDUCE THE 1542 01:10:25,084 --> 01:10:26,052 NEGATIVE PET SCANS AND GET 1543 01:10:26,052 --> 01:10:26,920 PEOPLE IN THROUGH THE SCREENING 1544 01:10:26,920 --> 01:10:29,389 PROCESS QUICKLY. 1545 01:10:29,389 --> 01:10:30,723 SO AGAIN THE POINT ISN'T REALLY 1546 01:10:30,723 --> 01:10:34,627 TO REDUCE THE NUMBER OF 1547 01:10:34,627 --> 01:10:37,397 POSITIVE PET SCANS BUT REDUCE 1548 01:10:37,397 --> 01:10:40,099 THE NUMBER OF NEGATIVE PET SCANS 1549 01:10:40,099 --> 01:10:46,072 AN DO NOT INCREASE THE BURDEN 1550 01:10:46,072 --> 01:10:47,507 FOR PEOPLE AND HOW DO WE LEVEL 1551 01:10:47,507 --> 01:10:50,810 THE PLAYING FIELD FOR DIFFERENT 1552 01:10:50,810 --> 01:10:51,444 GROUPS? 1553 01:10:51,444 --> 01:10:52,879 HERE'S DATA FROM HENRY FROM USC 1554 01:10:52,879 --> 01:10:55,848 AND YOU CAN SEE HERE BY USING 1555 01:10:55,848 --> 01:10:58,551 PLASMA BIOMARKERS WE CAN REALLY 1556 01:10:58,551 --> 01:11:00,286 START TO INCREASE THE NUMBER OF 1557 01:11:00,286 --> 01:11:03,590 PEOPLE WHO ARE PET ELIGIBLE. 1558 01:11:03,590 --> 01:11:06,225 SO AGAIN WE DID A PRESCREENER 1559 01:11:06,225 --> 01:11:10,196 AND EVERYONE DEEMED POSITIVE 1560 01:11:10,196 --> 01:11:12,632 WOULD GET A CONFIRMATORY PET 1561 01:11:12,632 --> 01:11:14,701 SCAN AND NOT AT THE POINT 1562 01:11:14,701 --> 01:11:17,337 BELIEVING WE CAN USE PLASMA 1563 01:11:17,337 --> 01:11:20,006 BIOMARKERS AS THE SOLE SCREENING 1564 01:11:20,006 --> 01:11:22,609 TECHNIQUE FOR GETTING PEOPLE 1565 01:11:22,609 --> 01:11:24,744 INTO A LOWER AMYLOID TREATMENT 1566 01:11:24,744 --> 01:11:28,281 AND WE DRAMATICALLY INCREASE THE 1567 01:11:28,281 --> 01:11:30,116 NUMBER OF PEOPLE WHO WERE PET 1568 01:11:30,116 --> 01:11:31,684 ELIGIBLE AND WERE ABLE IT COME 1569 01:11:31,684 --> 01:11:34,387 INTO THE TRIAL. 1570 01:11:34,387 --> 01:11:36,923 BASED ON ALL THESE DATA WE 1571 01:11:36,923 --> 01:11:38,491 PROPOSED TO TAKE SOME NEXT STEPS 1572 01:11:38,491 --> 01:11:44,130 TO EXPAND UPON THESE. 1573 01:11:44,130 --> 01:11:46,366 AGAIN, WHEN WE HAVE DONE THIS IN 1574 01:11:46,366 --> 01:11:49,669 THE PAST WE'VE HAD MOSTLY 1575 01:11:49,669 --> 01:11:50,303 NON-HISPANIC WHITES AND NEED TO 1576 01:11:50,303 --> 01:11:50,970 IMPROVE THAT AND GET THIS OUT TO 1577 01:11:50,970 --> 01:11:55,375 ALL THE DIFFERENT COMMUNITIES. 1578 01:11:55,375 --> 01:11:57,110 OUR INITIAL WORK DID NOT INCLUDE 1579 01:11:57,110 --> 01:11:57,744 DIVERSE PARTICIPANTS. 1580 01:11:57,744 --> 01:12:01,247 THE IDEA HERE FOR USING THE 1581 01:12:01,247 --> 01:12:03,650 HATCH COHORT AND OUR ONGOING 1582 01:12:03,650 --> 01:12:05,218 WORK IS TO CHANGE THIS. 1583 01:12:05,218 --> 01:12:06,719 WE'RE GOING TO ESTABLISH CUT 1584 01:12:06,719 --> 01:12:09,055 OFFS AND RANGES FOR ALL KINDS OF 1585 01:12:09,055 --> 01:12:10,390 ETHNIC GROUPS AND DO THAT WITH 1586 01:12:10,390 --> 01:12:13,693 THE FOLLOWING AIMS. 1587 01:12:13,693 --> 01:12:15,395 THIS IS AN RO1 SENT YESTERDAY. 1588 01:12:15,395 --> 01:12:19,232 IT'S ACTUALLY GOING TO HAPPEN 1589 01:12:19,232 --> 01:12:19,932 THANKS TO HER. 1590 01:12:19,932 --> 01:12:22,301 SHE DID KEEP ME IN SUSPENSE FOR 1591 01:12:22,301 --> 01:12:24,504 A LONG TIME AND KNOWS HOW TO 1592 01:12:24,504 --> 01:12:25,238 TORTURE ME. 1593 01:12:25,238 --> 01:12:28,574 WE'RE GOING TO LOOK AT NOVEL AND 1594 01:12:28,574 --> 01:12:30,043 EMERGING PLASMA BIOMARKERS 1595 01:12:30,043 --> 01:12:34,580 AMONGST THE DIFFERENT ETHNIC 1596 01:12:34,580 --> 01:12:35,515 GROUPS. 1597 01:12:35,515 --> 01:12:36,916 LOOKING AT THE PHOSPHO TAU 1598 01:12:36,916 --> 01:12:40,086 SPECIES AND A BETA SPECIES AND 1599 01:12:40,086 --> 01:12:43,756 LOOKING AT NTBR AND 1600 01:12:43,756 --> 01:12:45,291 PREDOMINANTLY USING MASS SPEC 1601 01:12:45,291 --> 01:12:47,160 AND WITH AMINO ASSAYS BECAUSE 1602 01:12:47,160 --> 01:12:47,994 THEY'RE SO HIGH THROUGHPUT. 1603 01:12:47,994 --> 01:12:51,698 THE IDEA IS TO TAKE A LOOK AND 1604 01:12:51,698 --> 01:12:54,634 EXAMINE HOW THEY RELATE TO 1605 01:12:54,634 --> 01:12:56,235 AMYLOID AND TAU PET. 1606 01:12:56,235 --> 01:12:57,704 WE'RE GOING TO BE USING OUR 1607 01:12:57,704 --> 01:13:00,239 CUT-OFFS AND THINGS WE USED FOR 1608 01:13:00,239 --> 01:13:00,907 NON-HISPANIC WHITES AND SEEING 1609 01:13:00,907 --> 01:13:04,977 HOW THEY MEASURE UP AND WHERE 1610 01:13:04,977 --> 01:13:06,312 THEY ARE IN OTHER ETHNIC GROUPS. 1611 01:13:06,312 --> 01:13:08,147 IN ADDITION TO LOOKING AT THESE 1612 01:13:08,147 --> 01:13:12,652 THINGS CROSS SECTIONALLY FROM A 1613 01:13:12,652 --> 01:13:14,087 SCREENING BASIS AND PREDICTION 1614 01:13:14,087 --> 01:13:16,322 BASIS WE'LL ALSO LOOK AT THEM 1615 01:13:16,322 --> 01:13:16,856 LONGITUDINALLY. 1616 01:13:16,856 --> 01:13:17,824 OVER THE NEXT FIVE YEARS WE'RE 1617 01:13:17,824 --> 01:13:20,626 GOING TO BE LOOKING AT HOW 1618 01:13:20,626 --> 01:13:23,129 PLASMA BIOMARKERS ARE CHANGING 1619 01:13:23,129 --> 01:13:25,364 AND HOW THOSE CHANGE IN TERMS OF 1620 01:13:25,364 --> 01:13:27,133 CHANGES IN COGNITION. 1621 01:13:27,133 --> 01:13:30,703 HOW THEY CHANGE IN TERMS OF 1622 01:13:30,703 --> 01:13:34,540 AMYLOID PET WORSENING AND TAU 1623 01:13:34,540 --> 01:13:36,609 PET WORSENING USING THE COHORT. 1624 01:13:36,609 --> 01:13:37,844 IT SHOULD BE AN EXCITING FIVE 1625 01:13:37,844 --> 01:13:40,780 YEARS AND I THINK IT WILL BE A 1626 01:13:40,780 --> 01:13:43,149 SEMINOLE STUDY TO TELL US HOW 1627 01:13:43,149 --> 01:13:45,118 BLOOD BIOMARKERS CHANGE AND 1628 01:13:45,118 --> 01:13:46,619 EVERYTHING ENDS UP IN GROUPS 1629 01:13:46,619 --> 01:13:49,021 BECAUSE WE HAVE SUCH A 1630 01:13:49,021 --> 01:13:50,623 TREMENDOUSLY CHARACTERIZED 1631 01:13:50,623 --> 01:13:53,526 COHORT. 1632 01:13:53,526 --> 01:13:54,127 ANYWAY I'LL STOP THERE. 1633 01:13:54,127 --> 01:14:01,634 THANK YOU FOR YOUR ATTENTION. 1634 01:14:01,634 --> 01:14:03,936 >> WE'RE NOW GOING TO SHIFT TO 1635 01:14:03,936 --> 01:14:05,438 OUR FIVE-PARENT PRESENTATIONS. 1636 01:14:05,438 --> 01:14:09,642 THE REST OF THE PANELISTS COULD 1637 01:14:09,642 --> 01:14:15,615 COME UP IT WILL BE IPSIT AND 1638 01:14:15,615 --> 01:14:17,750 NILUFER AND JESSICA AND ERIN. 1639 01:14:17,750 --> 01:14:19,318 COME UP AND BRING YOUR NAME 1640 01:14:19,318 --> 01:14:22,622 TAGS. 1641 01:14:22,622 --> 01:14:27,827 WE'LL GET STARTED HERE. 1642 01:14:27,827 --> 01:14:33,900 >> WE'LL START THIS PANEL OFF 1643 01:14:33,900 --> 01:14:38,704 WITH IP SET VAHIA FROM HARVARD 1644 01:14:38,704 --> 01:14:48,915 UNIVERSITY. 1645 01:14:58,424 --> 01:15:07,867 >> I'M A GERIATRIC SCIENTIST AND 1646 01:15:07,867 --> 01:15:08,801 PRESENT A CLINICIAN RESEARCHER 1647 01:15:08,801 --> 01:15:12,471 PERSPECTIVE ON OUR WORK IN 1648 01:15:12,471 --> 01:15:14,640 DIGITAL BIOMARKERS. 1649 01:15:14,640 --> 01:15:15,775 AND REALLY TEE OFF FROM WHERE 1650 01:15:15,775 --> 01:15:17,877 THE REST OF THE PANEL HAS GONE 1651 01:15:17,877 --> 01:15:19,212 WHICH IS DEMONSTRATING HOW THESE 1652 01:15:19,212 --> 01:15:21,380 ARE MOVING FROM THE INITIAL 1653 01:15:21,380 --> 01:15:26,586 PROOF OF CONCEPT VALIDATION 1654 01:15:26,586 --> 01:15:37,096 QUICKLY INTO AND I'M GOING TO 1655 01:15:45,638 --> 01:15:48,941 FOCUS LARGELY ON MOTION BASED 1656 01:15:48,941 --> 01:15:49,976 BIOMARKERS THOUGH AS WE'VE HEARD 1657 01:15:49,976 --> 01:15:51,510 THERE'S A NUMBER OF DIGITAL 1658 01:15:51,510 --> 01:15:53,145 BIOMARKERS USING SENSORY 1659 01:15:53,145 --> 01:15:55,848 MODALITIES INCLUDING VOICE AND 1660 01:15:55,848 --> 01:15:56,182 SOUND. 1661 01:15:56,182 --> 01:15:57,750 I HAVE MORE DATA THAN I'M 1662 01:15:57,750 --> 01:16:01,921 PRESENTING HERE BUT THIS WAS AT 1663 01:16:01,921 --> 01:16:06,459 THE SUGGESTION OF THE ORGANIZERS 1664 01:16:06,459 --> 01:16:08,394 AND RECOGNIZING THE ABSORPTION 1665 01:16:08,394 --> 01:16:09,228 CAPACITY FOR MORE DATA IS NOT 1666 01:16:09,228 --> 01:16:10,596 WHAT IT WAS ON DAY ONE. 1667 01:16:10,596 --> 01:16:13,933 YOU CAN SEE IN THE FIRST FIGURE 1668 01:16:13,933 --> 01:16:17,503 ON THE TOP LEFT BY GATHERING 1669 01:16:17,503 --> 01:16:20,673 DATA FROM RADIO WAVE BASED 1670 01:16:20,673 --> 01:16:22,341 SENSOR THAT EFFECTIVELY 1671 01:16:22,341 --> 01:16:26,712 FUNCTIONS AS AN IN-ROOM SAUNA IN 1672 01:16:26,712 --> 01:16:27,980 PEOPLE'S NATURAL LIVING 1673 01:16:27,980 --> 01:16:28,714 ENVIRONMENT WE'RE ABLE TO MAP 1674 01:16:28,714 --> 01:16:30,483 MOTION BASED ON HOW THE WAVES 1675 01:16:30,483 --> 01:16:33,686 BOUNCE OFFER THE BODY AND LAYER 1676 01:16:33,686 --> 01:16:35,221 IT AGAINST SPATIAL LOCATION AND 1677 01:16:35,221 --> 01:16:35,922 TIME STAMPING IT. 1678 01:16:35,922 --> 01:16:37,023 THE FIRST FIGURE DEMONSTRATES 1679 01:16:37,023 --> 01:16:41,694 HOW WE WERE ABLE TO DO AN N OF 1 1680 01:16:41,694 --> 01:16:44,730 STUDY DEMONSTRATING INCREASE IN 1681 01:16:44,730 --> 01:16:49,535 APATHY BY MAPPING LONGITUDINALLY 1682 01:16:49,535 --> 01:16:51,537 BY HOW MUCH TIME THE PERSON 1683 01:16:51,537 --> 01:16:53,773 SPENDS ON THE COUCH IN THE ROOM 1684 01:16:53,773 --> 01:16:58,377 AND AS THE TIME SPENT INCREASED 1685 01:16:58,377 --> 01:16:59,345 WE WERE ABLE TO MEASURE AGAINST 1686 01:16:59,345 --> 01:17:04,717 AN APATHY MARKER AND RADIO WAVE 1687 01:17:04,717 --> 01:17:06,252 SENSING CAN CAPTURE ACTIVATION. 1688 01:17:06,252 --> 01:17:08,487 WE TRACK ALL THE MOVEMENT THIS 1689 01:17:08,487 --> 01:17:11,457 PERSON MAKES IN THE ROOM FOR 24 1690 01:17:11,457 --> 01:17:13,092 HOURS LONGITUDINALLY GOING 1691 01:17:13,092 --> 01:17:13,759 FORWARD. 1692 01:17:13,759 --> 01:17:15,161 ONCE YOU PROCESS THE DATA USING 1693 01:17:15,161 --> 01:17:18,030 A SIGNAL PROCESSING APPROACH YOU 1694 01:17:18,030 --> 01:17:19,432 CAN DIFFERENTIATE A LOW ACTIVITY 1695 01:17:19,432 --> 01:17:22,635 FROM A HIGH ACTIVITY DAY AND 1696 01:17:22,635 --> 01:17:25,104 PICK UP QUITE EARLY WHETHER THIS 1697 01:17:25,104 --> 01:17:27,406 IS BECOMING PATHOLOGICAL AND 1698 01:17:27,406 --> 01:17:30,276 DRIFTING TO AGITATION. 1699 01:17:30,276 --> 01:17:31,577 WITH THIS EARLY VALIDATION IN 1700 01:17:31,577 --> 01:17:36,515 PLACE WE RECENTLY RESO LY RECEI 1701 01:17:36,515 --> 01:17:40,686 THE N RAT STUDY WHICH IS NIA 1702 01:17:40,686 --> 01:17:41,087 FUNDED. 1703 01:17:41,087 --> 01:17:42,655 WE'RE ADDING DATA FROM THE 1704 01:17:42,655 --> 01:17:46,926 MARKER INTO A STUDY LOOKING AT 1705 01:17:46,926 --> 01:17:52,565 WHETHER IT IMPACTS BRAIN BIO 1706 01:17:52,565 --> 01:17:54,467 ENNER GENETICS AND WITH THE 1707 01:17:54,467 --> 01:17:56,802 BIOMARKER IT'S ONE OF THE EARLY 1708 01:17:56,802 --> 01:17:58,504 STUDIES WITH DIGITAL PHENOTYPING 1709 01:17:58,504 --> 01:18:03,009 WITH GENETIC MARKERS AND THE 1710 01:18:03,009 --> 01:18:05,177 STUDY ASSOCIATIONS BETWEEN 1711 01:18:05,177 --> 01:18:06,078 THESE. 1712 01:18:06,078 --> 01:18:07,847 AND LOOKED AT THE A2 COLLECTIVE 1713 01:18:07,847 --> 01:18:09,882 TO PUT MOTION-BASED BIOMARKERS 1714 01:18:09,882 --> 01:18:13,819 IN THE CLINICAL SERVICE. 1715 01:18:13,819 --> 01:18:15,254 HERE WE USE WEARABLES AND THE 1716 01:18:15,254 --> 01:18:16,989 FIGURE ON THE BOTTOM LEFT IS A 1717 01:18:16,989 --> 01:18:18,991 MARK UP OF A DASHBOARD AS PART 1718 01:18:18,991 --> 01:18:20,126 OF THE STUDY AND HERE WE'RE 1719 01:18:20,126 --> 01:18:22,728 GOING TO LOOK AT WHETHER GIVING 1720 01:18:22,728 --> 01:18:27,767 CLINICIANS ACCESS TO MOTION DATA 1721 01:18:27,767 --> 01:18:30,836 IMPACTS THE PRACT IS AND SEEING 1722 01:18:30,836 --> 01:18:34,006 IF ADDING WEARABLE DATA ON THE 1723 01:18:34,006 --> 01:18:35,141 DASHBOARD IN SESSION LETS 1724 01:18:35,141 --> 01:18:36,175 CLINICIANS BETTER IDENTIFY 1725 01:18:36,175 --> 01:18:37,576 MEDICATION EFFECTS AND SIDE 1726 01:18:37,576 --> 01:18:43,249 EFFECTS AND NON-EFFECTS. 1727 01:18:43,249 --> 01:18:45,184 IT'S GOING TO FOCUS ON HIGH-RISK 1728 01:18:45,184 --> 01:18:51,390 PSYCHOTICS AND MOOD DISORDERS IN 1729 01:18:51,390 --> 01:18:52,825 PEOPLE WITH DEMENTIA. 1730 01:18:52,825 --> 01:18:54,260 AS IT PLAYS OUT IT'S THROWING 1731 01:18:54,260 --> 01:18:56,362 OUT IN REAL TIME COMPLICATED 1732 01:18:56,362 --> 01:18:57,063 QUESTIONS. 1733 01:18:57,063 --> 01:18:59,265 I'VE SPOTLIGHTED SOME OF THE 1734 01:18:59,265 --> 01:18:59,899 CHALLENGES AND OPPORTUNITIES 1735 01:18:59,899 --> 01:19:02,068 THAT HAVEN'T BEEN DISCUSSED SO 1736 01:19:02,068 --> 01:19:02,501 FAR. 1737 01:19:02,501 --> 01:19:05,104 A BIG ONE IS HAVING ALL THE DATA 1738 01:19:05,104 --> 01:19:06,539 DOES IT ACTUALLY TRANSLATE TO 1739 01:19:06,539 --> 01:19:08,074 ANYTHING IN TERMS OF CHANGING 1740 01:19:08,074 --> 01:19:08,707 CLINICAL PRACTICE. 1741 01:19:08,707 --> 01:19:10,943 WHAT'S THE IMPACT OF ACCESS TO 1742 01:19:10,943 --> 01:19:14,713 DATA ON CLINICAL DECISION 1743 01:19:14,713 --> 01:19:15,681 MAKING. 1744 01:19:15,681 --> 01:19:17,149 WHAT ARE THE RIGHT DATA SCREENS 1745 01:19:17,149 --> 01:19:21,153 TO USE FOR SPECIFIC USE CASES OR 1746 01:19:21,153 --> 01:19:21,454 INDICATIONS. 1747 01:19:21,454 --> 01:19:22,822 WHEN DO WE USE VOICE. 1748 01:19:22,822 --> 01:19:28,327 WHEN DO WITH USE SOUND AND 1749 01:19:28,327 --> 01:19:30,696 MOTION? 1750 01:19:30,696 --> 01:19:34,333 AND UPDATE TRAINING CURRICULA 1751 01:19:34,333 --> 01:19:36,001 AND REFLECT HOW ALL THE DATA 1752 01:19:36,001 --> 01:19:37,136 SHOULD BECOME PART OF STANDARD 1753 01:19:37,136 --> 01:19:37,870 OF CARE. 1754 01:19:37,870 --> 01:19:41,540 FINALLY THE BIG ONE IS GOING TO 1755 01:19:41,540 --> 01:19:45,311 BE AS WE START GETTING USED TO 1756 01:19:45,311 --> 01:19:46,812 USING HIGHLY INTRUSIVE 1757 01:19:46,812 --> 01:19:48,380 TECHNOLOGIES IN PEOPLE'S NATURAL 1758 01:19:48,380 --> 01:19:51,283 LIVING ENVIRONMENTS WE HAVE TO 1759 01:19:51,283 --> 01:19:57,823 THINK OF WHAT MALFEASANCE MEANS 1760 01:19:57,823 --> 01:19:58,858 AND THERE'S MUCH WORK TO BE 1761 01:19:58,858 --> 01:19:59,058 DONE. 1762 01:19:59,058 --> 01:20:07,566 THANK YOU. 1763 01:20:07,566 --> 01:20:10,436 >> THE NEXT PANELIST I THINK 1764 01:20:10,436 --> 01:20:14,874 WILL BE TAG TEAMED WITH MY 1765 01:20:14,874 --> 01:20:22,448 CO-CHAIR, DONNA WILCOCK AND 1766 01:20:22,448 --> 01:20:22,648 ERIN. 1767 01:20:22,648 --> 01:20:26,185 >> SO GOOD MORNING, EVERYONE. 1768 01:20:26,185 --> 01:20:28,921 I WAS TALKING ABOUT VASCULAR 1769 01:20:28,921 --> 01:20:30,289 CONTRIBUTIONS TO COGNITIVE 1770 01:20:30,289 --> 01:20:33,792 IMPAIRMENT AND DEMENTIA. 1771 01:20:33,792 --> 01:20:36,295 AND SPECIFICALLY THE MARK VACD 1772 01:20:36,295 --> 01:20:38,164 CONSORTIUM AND THE PROGRESS MADE 1773 01:20:38,164 --> 01:20:40,266 BY THAT CONSORTIUM. 1774 01:20:40,266 --> 01:20:43,202 FIRST I THOUGHT IT WOULD BE A 1775 01:20:43,202 --> 01:20:44,370 GOOD INTRODUCTION TO GIVE AN 1776 01:20:44,370 --> 01:20:46,639 OVERVIEW OF WHAT WE THINK ABOUT 1777 01:20:46,639 --> 01:20:48,641 WHEN WE THINK ABOUT VASCULAR 1778 01:20:48,641 --> 01:20:49,742 CONTRIBUTIONS TO COGNITIVE 1779 01:20:49,742 --> 01:20:53,779 IMPAIRMENT AND DEMENTIA FROM NOW 1780 01:20:53,779 --> 01:20:55,748 ON I'LL SAY VCID. 1781 01:20:55,748 --> 01:20:58,717 THE PATHOLOGIES IS AN UMBRELLA 1782 01:20:58,717 --> 01:21:01,487 FOR MANY VASCULAR PATHOLOGIES 1783 01:21:01,487 --> 01:21:12,031 RANGING FROM INFARCTS AND MICRO 1784 01:21:12,765 --> 01:21:15,834 BLEEDS AND SMALL VESSEL 1785 01:21:15,834 --> 01:21:18,704 HEMORRHAGIC STROKE TO LARGE 1786 01:21:18,704 --> 01:21:22,474 VESSEL ISCHEMIC AND HEMORRHAGIC 1787 01:21:22,474 --> 01:21:27,546 STROKE CONTRIBUTING TO COGNITIVE 1788 01:21:27,546 --> 01:21:27,813 FUNCTION. 1789 01:21:27,813 --> 01:21:36,922 SO THE MARK VCID IS A CONSORTIUM 1790 01:21:36,922 --> 01:21:41,560 IN ITS SECOND PHASE AND IN YEAR 1791 01:21:41,560 --> 01:21:47,366 EIGHT AT THIS POINT AN NINDS 1792 01:21:47,366 --> 01:21:48,634 FUNDED CONSORTIUM. 1793 01:21:48,634 --> 01:21:51,437 WE HAVE SEVEN SITES AROUND THE 1794 01:21:51,437 --> 01:21:52,738 NATION AND THE NEW ITERATION 1795 01:21:52,738 --> 01:21:55,841 FUNDED A COUPLE YEARS AGO WE NOW 1796 01:21:55,841 --> 01:21:58,310 HAVE NINE SITES WITHIN THE 1797 01:21:58,310 --> 01:22:00,346 CONSORTIUM THAT COORDINATING 1798 01:22:00,346 --> 01:22:02,681 CENTER IS HOUSED AT MGH. 1799 01:22:02,681 --> 01:22:06,685 AND THE GOAL OF MARK VCID IS NOT 1800 01:22:06,685 --> 01:22:10,256 ONLY TO IDENTIFY CANDIDATE 1801 01:22:10,256 --> 01:22:14,693 BIOMARKERS FOR VCID IN 1802 01:22:14,693 --> 01:22:16,228 PARTICULAR CEREBRAL SMALL VESSEL 1803 01:22:16,228 --> 01:22:18,530 DISEASE AND CROSS-SITE VALIDATE 1804 01:22:18,530 --> 01:22:21,000 AMONG THE NINE SITES THESE 1805 01:22:21,000 --> 01:22:22,735 BIOMARKERS TO ENSURE ROBUSTNESS 1806 01:22:22,735 --> 01:22:28,474 AND VALIDITY. 1807 01:22:28,474 --> 01:22:31,176 WHAT ARE THE MARK VCID 1808 01:22:31,176 --> 01:22:31,777 BIOMARKERS. 1809 01:22:31,777 --> 01:22:33,345 THERE'S A NUMBER OF NEURO 1810 01:22:33,345 --> 01:22:36,849 IMAGING BIOMARKERS AND I'M NOT A 1811 01:22:36,849 --> 01:22:38,250 NEURO IMAGIST SO I CAN'T GO INTO 1812 01:22:38,250 --> 01:22:41,520 DETAIL BUT THESE ARE THE KITS 1813 01:22:41,520 --> 01:22:44,590 BEING CROSS-SITE VALIDATED 1814 01:22:44,590 --> 01:22:47,393 INCLUDING AN IMAGING BASED 1815 01:22:47,393 --> 01:22:50,696 ALGORITHM FOR ARTERIAL SCLEROSIS 1816 01:22:50,696 --> 01:22:52,665 AND VASCULAR REACTIVITY GIVING 1817 01:22:52,665 --> 01:22:53,465 US INFORMATION ABOUT THE 1818 01:22:53,465 --> 01:22:58,704 FUNCTION OF THE VESSEL AND HOW 1819 01:22:58,704 --> 01:23:05,210 FUNCTIONAL THE IMPROVED 1820 01:23:05,210 --> 01:23:06,111 CHARACTERIZATION FOR WHITE 1821 01:23:06,111 --> 01:23:08,414 MATTER CHANGE AND FREE WATER 1822 01:23:08,414 --> 01:23:10,182 WHICH IS ANOTHER MEASURE OF 1823 01:23:10,182 --> 01:23:14,687 INFLAMMATION AND WHITE MATTER 1824 01:23:14,687 --> 01:23:14,987 INTEGRITY. 1825 01:23:14,987 --> 01:23:19,291 MARK VCID HAD A PLACENTAL GROWTH 1826 01:23:19,291 --> 01:23:21,794 FACTOR AND THAT LOOKS LIKE A 1827 01:23:21,794 --> 01:23:23,228 PROMISING BIOMARKER FOR CEREBRAL 1828 01:23:23,228 --> 01:23:25,964 SMALL VESSEL DISEASE ON THE 1829 01:23:25,964 --> 01:23:29,034 BOTTOM RIGHT AND THE GRAPH IS 1830 01:23:29,034 --> 01:23:31,103 YOU CAN SEE THE DIAGNOSTIC 1831 01:23:31,103 --> 01:23:33,172 ACCURACY OF PLACENTA GROWTH 1832 01:23:33,172 --> 01:23:39,178 FACTOR FOR VASCULAR DEMENTIA WAS 1833 01:23:39,178 --> 01:23:45,984 POINT 89 AND FOR VCI IT WAS .74. 1834 01:23:45,984 --> 01:23:48,220 IT'S A PROMISING BIOMARKER WE'RE 1835 01:23:48,220 --> 01:23:49,421 CONTINUING TO LOOK AT. 1836 01:23:49,421 --> 01:23:55,160 IN THINKING OF THE CHALLENGES OF 1837 01:23:55,160 --> 01:24:01,867 BIOMARKER FOR VCI D WE HAVE A 1838 01:24:01,867 --> 01:24:05,671 LACK OF BIOMARKERS TO VALIDATE 1839 01:24:05,671 --> 01:24:07,306 BEYOND NEUROPATHOLOGY OUR 1840 01:24:07,306 --> 01:24:10,709 IMAGING OF ESPECIALLY THE SMALL 1841 01:24:10,709 --> 01:24:15,848 SELF INSULTS IN THE BRAIN IS 1842 01:24:15,848 --> 01:24:16,982 QUITE POOR AND USED WHITE MATTER 1843 01:24:16,982 --> 01:24:22,154 INNENCE TI AS AN INDICATOR -- 1844 01:24:22,154 --> 01:24:23,655 INTENSITY AS AN INDICATOR AND 1845 01:24:23,655 --> 01:24:25,057 IT'S THE TIP OF THE ICEBERG WHEN 1846 01:24:25,057 --> 01:24:25,624 IT COMES TO VASCULAR 1847 01:24:25,624 --> 01:24:29,061 PATHOLOGIES. 1848 01:24:29,061 --> 01:24:32,264 AND AMYLOID ACCUMULATION 1849 01:24:32,264 --> 01:24:32,898 INDEPENDENTLY CONTRIBUTE TO 1850 01:24:32,898 --> 01:24:33,799 WHITE MATTER INTENSITY. 1851 01:24:33,799 --> 01:24:35,100 WHEN WE THINK ABOUT THE REAL 1852 01:24:35,100 --> 01:24:37,469 WORLD MANY TIMES WE HAVE 1853 01:24:37,469 --> 01:24:39,705 PATIENTS WHO HAVE BOTH VASCULAR 1854 01:24:39,705 --> 01:24:43,442 CONTRIBUTIONS TO THEIR COGNITIVE 1855 01:24:43,442 --> 01:24:44,443 IMPAIRMENT AS WELL AS ALZHEIMER 1856 01:24:44,443 --> 01:24:46,545 CONTRIBUTIONS. 1857 01:24:46,545 --> 01:24:47,679 UNDERSTANDING HOW MUCH OF THAT 1858 01:24:47,679 --> 01:24:50,149 WMH IS BEING CONTRIBUTED TO 1859 01:24:50,149 --> 01:24:53,051 AMYLOID VERSUS VASCULAR INSULTS 1860 01:24:53,051 --> 01:24:54,486 IS CHALLENGING. 1861 01:24:54,486 --> 01:24:56,054 EVEN OUR PARENT PATHOLOGIC 1862 01:24:56,054 --> 01:24:59,057 ASSESSMENT OF PATHOLOGIES IS 1863 01:24:59,057 --> 01:25:00,426 MINIMALLY INFORMATIVE BECAUSE WE 1864 01:25:00,426 --> 01:25:03,962 DO A LOT OF RANDOM SAMPLING IN 1865 01:25:03,962 --> 01:25:05,798 NEURO PATHOLOGY SO IT'S HIT OR 1866 01:25:05,798 --> 01:25:08,767 MISS WHETHER IN THAT PIECE OF 1867 01:25:08,767 --> 01:25:11,937 TISSUE YOU WILL FIND A MICRO 1868 01:25:11,937 --> 01:25:14,139 INFARCT OR NOT IT'S DEFINED AS 1869 01:25:14,139 --> 01:25:15,174 PRESENCE OR ABSENCE OF THE 1870 01:25:15,174 --> 01:25:18,710 HALLMARKS ARE NOT QUANTIFIABLE. 1871 01:25:18,710 --> 01:25:26,185 WE HAVE A LACK OF QUANTIFY WITH 1872 01:25:26,185 --> 01:25:27,719 CAA AND WE'RE MISSING PATHOLOGY. 1873 01:25:27,719 --> 01:25:28,520 WITH THAT I'LL WRAP UP AND WE'LL 1874 01:25:28,520 --> 01:25:28,754 MOVE ON. 1875 01:25:28,754 --> 01:25:35,561 THANK YOU. 1876 01:25:35,561 --> 01:25:36,028 >> THANK YOU. 1877 01:25:36,028 --> 01:25:43,669 SO I'M GOING TO TALK ABOUT THE 1878 01:25:43,669 --> 01:25:46,138 CLEAR AD U19 LONGITUDINAL 1879 01:25:46,138 --> 01:25:46,805 BIOMARKERS OF ALZHEIMER'S 1880 01:25:46,805 --> 01:25:50,709 DISEASE IN MULTI-ETHNIC 1881 01:25:50,709 --> 01:25:51,009 POPULATIONS. 1882 01:25:51,009 --> 01:25:53,445 AND AS WE HEARD IN THE PREVIOUS 1883 01:25:53,445 --> 01:25:55,647 TALK THIS IS A LARGE CONSORTIUM 1884 01:25:55,647 --> 01:25:57,983 EFFORT LED BY THE MAYO CLINIC 1885 01:25:57,983 --> 01:26:00,652 AND INDIANA UNIVERSITY WITH 13 1886 01:26:00,652 --> 01:26:02,688 SITES AND OVER 100 1887 01:26:02,688 --> 01:26:03,255 INVESTIGATORS. 1888 01:26:03,255 --> 01:26:06,692 ON THE TOP LEFT THERE YOU SEE 1889 01:26:06,692 --> 01:26:10,362 THE PRECISION BIOMARKER 1890 01:26:10,362 --> 01:26:10,629 FRAMEWORK. 1891 01:26:10,629 --> 01:26:14,132 WE ALL HEARD ABOUT AMYLOID TAU 1892 01:26:14,132 --> 01:26:17,069 NEURODEGENERATION AS BIOMARKERS 1893 01:26:17,069 --> 01:26:23,075 OF KEY NEUROPA PAPATHOLOGIES AN 1894 01:26:23,075 --> 01:26:24,843 THERE'S MORE UNDER THE ICEBERG 1895 01:26:24,843 --> 01:26:27,379 IT'S A COMPLEX DISEASE AND WE 1896 01:26:27,379 --> 01:26:29,548 HEARD ABOUT IT THROUGHOUT THE 1897 01:26:29,548 --> 01:26:30,382 TALKS. 1898 01:26:30,382 --> 01:26:32,885 I WON'T BELABOR THAT. 1899 01:26:32,885 --> 01:26:38,524 THE PREMISE OF CLEAR AD IS THERE 1900 01:26:38,524 --> 01:26:40,225 ARE COMPLEX MOLECULAR 1901 01:26:40,225 --> 01:26:41,593 PERTURBATIONS IN THE BRAIN AND 1902 01:26:41,593 --> 01:26:46,365 WE HEARD ABOUT THESE 1903 01:26:46,365 --> 01:26:48,267 PERTURBATIONS IN MANY 1904 01:26:48,267 --> 01:26:49,001 MULTI-OMICS TALKS. 1905 01:26:49,001 --> 01:26:53,772 AND CLEAR AD AIMS TO IDENTIFY 1906 01:26:53,772 --> 01:26:56,441 NOT ONLY THE CENTRAL MOLECULAR 1907 01:26:56,441 --> 01:26:58,076 SIGNATURES OF DISEASE BUT ALSO 1908 01:26:58,076 --> 01:27:02,214 TO CAPTURE THEM IN PERIPHERY IN 1909 01:27:02,214 --> 01:27:06,685 THE SO CALLED CENTRALLY LINKED 1910 01:27:06,685 --> 01:27:08,987 PERIPHERAL MOLECULAR SIGNATURES. 1911 01:27:08,987 --> 01:27:13,325 ON THE TOP RIGHT IS THE 1912 01:27:13,325 --> 01:27:15,594 FRAMEWORK FOR THE PROGRAM. 1913 01:27:15,594 --> 01:27:19,965 THE MOLECULAR PERTURBATIONS WILL 1914 01:27:19,965 --> 01:27:23,201 BE CAPTURED USING A PENTAOMICS 1915 01:27:23,201 --> 01:27:25,504 APPROACH LOOK AT THE BIOLOGICAL 1916 01:27:25,504 --> 01:27:27,739 PATHWAYS THAT THESE 1917 01:27:27,739 --> 01:27:29,741 PERTURBATIONS FALL INTO IN A 1918 01:27:29,741 --> 01:27:32,044 TIERED MECHANISM. 1919 01:27:32,044 --> 01:27:38,684 THE CENTER OF THE TIER ARE THOSE 1920 01:27:38,684 --> 01:27:41,053 BIOLOGICAL PATHWAYS THAT ARE 1921 01:27:41,053 --> 01:27:44,489 MOST PROVEN IN ALZHEIMER'S 1922 01:27:44,489 --> 01:27:44,723 DISEASE. 1923 01:27:44,723 --> 01:27:46,091 THE OUTER TIER PATHWAYS ARE 20 1924 01:27:46,091 --> 01:27:49,194 MORE AND THE OUTER MOST TIER IS 1925 01:27:49,194 --> 01:27:50,696 THE DISCOVERY SPACE. 1926 01:27:50,696 --> 01:27:52,197 WE'LL BE TAKING A LOOK AT THESE 1927 01:27:52,197 --> 01:27:57,135 PERTURBATIONS IN THE CONTEXT OF 1928 01:27:57,135 --> 01:27:58,604 THE ENVIRONMENT IN THE CONTEXT 1929 01:27:58,604 --> 01:28:00,138 OF ALZHEIMER'S DISEASE 1930 01:28:00,138 --> 01:28:04,176 COPATHOLOGIES AND COMORBIDITIES 1931 01:28:04,176 --> 01:28:09,915 IN MULTI-ETHNIC POPULATIONS 1932 01:28:09,915 --> 01:28:10,716 COMPRISING AFRICAN AMERICAN AND 1933 01:28:10,716 --> 01:28:12,751 LATIN AMERICANS AND NON-HISPANIC 1934 01:28:12,751 --> 01:28:15,253 WHITES AND WE'LL BE CORRELATING 1935 01:28:15,253 --> 01:28:18,690 THE MULTI-OMICS MEASURES AND 1936 01:28:18,690 --> 01:28:20,292 BIOLOGICAL PERTURBATIONS TO A 1937 01:28:20,292 --> 01:28:21,426 VARIETY OF ENDO PHENOTYPES 1938 01:28:21,426 --> 01:28:22,728 INCLUDING BUT NOT LIMITED TO 1939 01:28:22,728 --> 01:28:26,298 COGNITIVE IMAGING AND THE 1940 01:28:26,298 --> 01:28:27,432 ROUTINELY MEASURED PERIPHERAL 1941 01:28:27,432 --> 01:28:31,837 BIOMARKERS OF ATN. 1942 01:28:31,837 --> 01:28:34,706 SO THE LOWER LEFT ARE THE 1943 01:28:34,706 --> 01:28:38,043 EXPECTED OUTCOMES OF IDENTIFYING 1944 01:28:38,043 --> 01:28:39,277 THE SIGNATURES WHERE IN THE 1945 01:28:39,277 --> 01:28:42,247 FUTURE THE SIGNATURES WILL THEN 1946 01:28:42,247 --> 01:28:45,417 BECOME THE PRECISION BIOMARKERS. 1947 01:28:45,417 --> 01:28:48,053 THE PROGRAM AIMS TO ESTABLISH AN 1948 01:28:48,053 --> 01:28:50,689 APPROACH, A PIPELINE FOR 1949 01:28:50,689 --> 01:28:54,359 PRECISION BIOMARKERS IN 1950 01:28:54,359 --> 01:28:54,793 ALZHEIMER'S DISEASE. 1951 01:28:54,793 --> 01:28:57,729 WE'LL IDENTIFY NOT ONLY THE 1952 01:28:57,729 --> 01:29:00,532 PRECISION SIGNATURES BUT THAT 1953 01:29:00,532 --> 01:29:02,467 THESE SIGNATURES CAN THEMSELVES 1954 01:29:02,467 --> 01:29:04,302 BECOME THERAPEUTIC TARGETS AS WE 1955 01:29:04,302 --> 01:29:08,206 HEARD FROM OTHER SPEAKERS TODAY. 1956 01:29:08,206 --> 01:29:11,076 AND IMPORTANTLY THE PROGRAM ALSO 1957 01:29:11,076 --> 01:29:13,011 OFFERS A TWO-YEAR SCHOLARSHIP. 1958 01:29:13,011 --> 01:29:14,513 IF YOU'D LIKE TO LEARN MORE 1959 01:29:14,513 --> 01:29:17,282 ABOUT IT, PLEASE CHECK OUT OUR 1960 01:29:17,282 --> 01:29:21,286 WEBSITE CLEAR AD.org. 1961 01:29:21,286 --> 01:29:26,525 SOME OUTCOMES OF THE PROGRAM YOU 1962 01:29:26,525 --> 01:29:31,263 CAN FIND ON THE WEBSITE AND 1963 01:29:31,263 --> 01:29:33,165 EXAMPLES ON THE LOWER RIGHT HAND 1964 01:29:33,165 --> 01:29:35,434 CORNER AND HIGHLIGHT A 1965 01:29:35,434 --> 01:29:42,107 PUBLICATION FROM OUR GROUP P 1966 01:29:42,107 --> 01:29:46,712 PUBLICATION USING SINGLE NUCLEI 1967 01:29:46,712 --> 01:29:50,215 RNA SEQ IN A BRAIN TISSUE. 1968 01:29:50,215 --> 01:29:54,686 WE HAVE IDENTIFIED A MOLECULAR 1969 01:29:54,686 --> 01:30:00,826 DUO, A SMAT 3NGEEFA PERTURBED 1970 01:30:00,826 --> 01:30:03,261 AND MAY UNDER LIE BLOOD BRAIN 1971 01:30:03,261 --> 01:30:04,129 BARRIER DYSFUNCTION IN 1972 01:30:04,129 --> 01:30:06,698 ALZHEIMER'S DISEASE. 1973 01:30:06,698 --> 01:30:09,868 BOTH BASED ON OUR DATA EXTERNAL 1974 01:30:09,868 --> 01:30:12,838 DATA AS WELL AS MODEL SYSTEMS 1975 01:30:12,838 --> 01:30:15,373 INCLUDING INDUCED PLURIPOTENT 1976 01:30:15,373 --> 01:30:19,077 STEM CELL DERIVED PERICYTES. 1977 01:30:19,077 --> 01:30:22,047 THE SMAT 3 WHICH IS PERTURBED IN 1978 01:30:22,047 --> 01:30:26,685 PERICYTES WHEN MEASURED IN BLOOD 1979 01:30:26,685 --> 01:30:29,054 ALSO DOES CORRELATE WITH NEURO 1980 01:30:29,054 --> 01:30:30,122 IMAGING BIOMARKERS OF 1981 01:30:30,122 --> 01:30:33,091 ALZHEIMER'S DISEASE SPECIFICALLY 1982 01:30:33,091 --> 01:30:38,230 AMYLOID DEPOSITION AND CORTICAL 1983 01:30:38,230 --> 01:30:45,670 ATROPHY THEREBY PROVIDING A LINK 1984 01:30:45,670 --> 01:30:46,705 BETWEEN ALZHEIMER'S DISEASE AND 1985 01:30:46,705 --> 01:30:50,675 CENTRAL PERIPHERY LINK. 1986 01:30:50,675 --> 01:30:53,044 WITH THAT I'LL STOP. 1987 01:30:53,044 --> 01:30:57,682 >> SO OUR NEXT SPEAKER IS 1988 01:30:57,682 --> 01:30:58,717 JESSICA FAUL FROM THE UNIVERSITY 1989 01:30:58,717 --> 01:30:59,951 OF MICHIGAN. 1990 01:30:59,951 --> 01:31:03,188 I HAVE TO SAY, GO BLUE. 1991 01:31:03,188 --> 01:31:05,991 >> SO WE'LL SWITCH GEARS A 1992 01:31:05,991 --> 01:31:07,192 LITTLE BIT AND TAKE A BIG 1993 01:31:07,192 --> 01:31:08,527 PICTURE VIEW. 1994 01:31:08,527 --> 01:31:10,395 WHAT WE FELT WAS NEEDED WAS TO 1995 01:31:10,395 --> 01:31:16,334 REPLICATE THE WORK DONE ON BLOOD 1996 01:31:16,334 --> 01:31:17,102 BRAIN BARRIER BUT USING A 1997 01:31:17,102 --> 01:31:19,604 REPRESENTATIVE POPULATION BASED 1998 01:31:19,604 --> 01:31:22,274 AND DIVERSE SAMPLE AND WE HAD A 1999 01:31:22,274 --> 01:31:23,575 LONGITUDINAL PANEL STUDY WITH A 2000 01:31:23,575 --> 01:31:25,744 REPRESENTATIVE SAMPLE OF ADULTS 2001 01:31:25,744 --> 01:31:27,279 IN THE U.S. OVER AGE 50 EVERY 2002 01:31:27,279 --> 01:31:29,748 TWO YEARS WITH AN OVERSAMPLING 2003 01:31:29,748 --> 01:31:31,483 OF RACE AND ETHNIC MINORITIES. 2004 01:31:31,483 --> 01:31:37,055 WE MEASURED A BETA 42/40 RATIO 2005 01:31:37,055 --> 01:31:39,858 AND P TAU 181 AND REPRESENTATIVE 2006 01:31:39,858 --> 01:31:42,127 SUBSET OF PARTICIPANTS BORN IN 2007 01:31:42,127 --> 01:31:43,128 1959 AND EARLIER. 2008 01:31:43,128 --> 01:31:49,167 SO THE SUB SAMPLE WAS ABOUT 2009 01:31:49,167 --> 01:31:49,901 4,000 PEOPLE. 2010 01:31:49,901 --> 01:31:55,106 BEFORE THIS WE HAD TO SHOW THIS 2011 01:31:55,106 --> 01:31:56,675 WAS FEASIBLE AND WE'RE 2012 01:31:56,675 --> 01:31:58,977 COLLECTING BLOOD IN PARTICIPANTS 2013 01:31:58,977 --> 01:32:01,446 HOME SHIPPED TO A LABORATORY AND 2014 01:32:01,446 --> 01:32:02,681 DEVIATING FROM CLINICAL BEST 2015 01:32:02,681 --> 01:32:03,849 PRACTICE. 2016 01:32:03,849 --> 01:32:05,684 THIS LINKS TO THE PUBLICATION 2017 01:32:05,684 --> 01:32:06,885 FROM THE PILOT STUDY. 2018 01:32:06,885 --> 01:32:09,688 WE LEARNED IT WAS POSSIBLE WITH 2019 01:32:09,688 --> 01:32:10,689 SOME CAVEATS. 2020 01:32:10,689 --> 01:32:12,524 WE WERE ABLE TO USE PLASMA FOR 2021 01:32:12,524 --> 01:32:16,228 THE A BETA 42 AND 40 MEASUREMENT 2022 01:32:16,228 --> 01:32:18,563 BUT COULD ONLY LOOK AT IT AS A 2023 01:32:18,563 --> 01:32:20,031 RATIO BECAUSE THE TOTAL AMOUNT 2024 01:32:20,031 --> 01:32:22,033 OF A BETA DECLINED BECAUSE OF 2025 01:32:22,033 --> 01:32:23,368 THE DELAY PROCESSING ABOUT THE 2026 01:32:23,368 --> 01:32:27,806 THE RATIO REMAINED CONSTANT. 2027 01:32:27,806 --> 01:32:30,809 NFL AND G FAB WERE UNCHANGED AN 2028 01:32:30,809 --> 01:32:33,345 FOR P TAU WE HAD TO SWITCH TO 2029 01:32:33,345 --> 01:32:36,147 SERUM BECAUSE OF THE THEY ARE IN 2030 01:32:36,147 --> 01:32:38,083 PROCESSING LEADS TO ARTIFICIALLY 2031 01:32:38,083 --> 01:32:39,951 HIGH PHOSPHORYLATION AND WEREN'T 2032 01:32:39,951 --> 01:32:43,388 ABLE TO USE THE PLASMA SAMPLE. 2033 01:32:43,388 --> 01:32:44,623 WE USED THE ASSAY AND THEN IN 2034 01:32:44,623 --> 01:32:47,058 THE STUDY WE COMPARED IT TO OUR 2035 01:32:47,058 --> 01:32:48,326 COGNITIVE TESTS. 2036 01:32:48,326 --> 01:32:52,898 HERE WE'RE LOOKING AT MEDIA AND 2037 01:32:52,898 --> 01:32:54,366 ADELAY RECALL AND BACKWARDS 2038 01:32:54,366 --> 01:32:57,369 COUNTING AS A TOTAL SCORE FROM 0 2039 01:32:57,369 --> 01:33:00,205 TO 27 AND APPLIED THE DIAGNOSTIC 2040 01:33:00,205 --> 01:33:02,274 ALGORITHM VALIDATED IN OTHER 2041 01:33:02,274 --> 01:33:03,875 STUDIES TO PREDICT DEMENTIA 2042 01:33:03,875 --> 01:33:04,109 STATUS. 2043 01:33:04,109 --> 01:33:06,378 ON THE FAR SIDE YOU CAN SEE SOME 2044 01:33:06,378 --> 01:33:08,580 DESCRIPTIVES AND I WANTED TO 2045 01:33:08,580 --> 01:33:12,484 POINT OUT WE ALSO HAD APOE E4 2046 01:33:12,484 --> 01:33:14,519 ALLELE STATUS FROM PRIOR 2047 01:33:14,519 --> 01:33:15,954 GENOTYPING EFFORTS AND WHAT WE 2048 01:33:15,954 --> 01:33:18,690 FOUND THE MARKERS GENERALLY WERE 2049 01:33:18,690 --> 01:33:21,393 MODERATELY CORRELATED. 2050 01:33:21,393 --> 01:33:25,764 SO SPECIFICALLY NFL G FAB AND A 2051 01:33:25,764 --> 01:33:28,867 BETA 42/40 WAS ONLY WEAKLY 2052 01:33:28,867 --> 01:33:32,170 RELATED TO PAV OF P TAU FOR THE 2053 01:33:32,170 --> 01:33:35,006 MOST PART THEY MEASURE 2054 01:33:35,006 --> 01:33:36,708 DISTINCTIVE THINK AND SAW THE 2055 01:33:36,708 --> 01:33:40,245 AGE-RELATED PATTERNS WE EXPECTED 2056 01:33:40,245 --> 01:33:43,682 BUT NO DIFFERENCES FOR THE A 2057 01:33:43,682 --> 01:33:45,750 BETA 42/40 RATIO. 2058 01:33:45,750 --> 01:33:49,955 WE WERE LOOKING FOR RACE AND 2059 01:33:49,955 --> 01:33:51,489 ETHNIC DIFFERENCES AND WE DIDN'T 2060 01:33:51,489 --> 01:33:53,525 SEE DIFFERENCES IN MEANS ACROSS 2061 01:33:53,525 --> 01:33:55,093 THE BIOMARKERS BUT SEE A 2062 01:33:55,093 --> 01:33:56,227 DIFFERENCE IN HOW WELL THEY 2063 01:33:56,227 --> 01:33:58,263 PREDICTED OUTCOMES. 2064 01:33:58,263 --> 01:34:00,632 SO IN OUR SAMPLE NFL P TAU AND G 2065 01:34:00,632 --> 01:34:04,035 FAB WERE PREDICTIVE OF COGNITIVE 2066 01:34:04,035 --> 01:34:05,971 SCORE CROSS SECTIONALLY IN THE 2067 01:34:05,971 --> 01:34:08,907 ENTIRE SAMPLE AND THE A BETA 2068 01:34:08,907 --> 01:34:11,676 42/40 WAS PREDICTIVE OF 2069 01:34:11,676 --> 01:34:13,011 COGNITIVE SCORE IN THE WHITE 2070 01:34:13,011 --> 01:34:13,445 SAMPLE. 2071 01:34:13,445 --> 01:34:15,113 AND NFL WAS REALLY THE ONLY 2072 01:34:15,113 --> 01:34:17,582 MARKER THAT CONSISTENTLY 2073 01:34:17,582 --> 01:34:19,351 PREDICTED COGNITIVE FUNCTIONING 2074 01:34:19,351 --> 01:34:24,089 ACROSS ALL THE RACE/ETHNIC 2075 01:34:24,089 --> 01:34:24,990 GROUPS. 2076 01:34:24,990 --> 01:34:27,792 THIS SLIDE LOOKS WONKY SHOWING 2077 01:34:27,792 --> 01:34:31,596 THE RELATIONSHIP WITH THE CROSS 2078 01:34:31,596 --> 01:34:33,565 SECTIONAL COGNITIVE SCORE. 2079 01:34:33,565 --> 01:34:36,735 WHEN WE LOOKED AT THE MARKERS 2080 01:34:36,735 --> 01:34:37,669 TOGETHER, NFL COMES OUTS THE 2081 01:34:37,669 --> 01:34:39,671 STRONGEST PREDICTOR OF COGNITIVE 2082 01:34:39,671 --> 01:34:39,938 FUNCTION. 2083 01:34:39,938 --> 01:34:42,774 WE ALSO HAD THE ABILITY TO LOOK 2084 01:34:42,774 --> 01:34:43,942 LONGITUDINALLY FOUR YEARS OUT 2085 01:34:43,942 --> 01:34:46,711 FROM THE TIME OF MEASUREMENT AND 2086 01:34:46,711 --> 01:34:48,313 THE TABLE SHOWS WHAT THAT LOOKS 2087 01:34:48,313 --> 01:34:49,681 LIKE AND AGAIN NFL WAS THE 2088 01:34:49,681 --> 01:34:53,351 MARKER THAT WAS ABLE TO PREDICT 2089 01:34:53,351 --> 01:34:54,686 DEMENTIA AND DEATH TWO AND FOUR 2090 01:34:54,686 --> 01:34:58,223 YEAR AFTER THE MEASUREMENT OF 2091 01:34:58,223 --> 01:34:59,024 THE BIOMARKER. 2092 01:34:59,024 --> 01:35:02,594 AND AGAIN CONSISTENT ACROSS RACE 2093 01:35:02,594 --> 01:35:04,963 AND ETHNIC GROUPS IN CONCLUSION 2094 01:35:04,963 --> 01:35:06,464 THE MARKERS CAN BE MEASURED IN 2095 01:35:06,464 --> 01:35:09,267 POPULATION-BASED STUDIES WITH 2096 01:35:09,267 --> 01:35:11,036 CAVEATS AND APPROPRIATE 2097 01:35:11,036 --> 01:35:11,302 PROTOCOLS. 2098 01:35:11,302 --> 01:35:13,304 THE BIOMARKERS RELATED TO 2099 01:35:13,304 --> 01:35:15,440 CROSS-SECTIONAL AND LONGITUDINAL 2100 01:35:15,440 --> 01:35:17,709 FUNCTIONING AND SAW LITTLE 2101 01:35:17,709 --> 01:35:19,344 EVIDENCE OF RACE AND ETHNIC 2102 01:35:19,344 --> 01:35:20,311 DIFFERENCES IN MEANS BUT SOME 2103 01:35:20,311 --> 01:35:21,846 ABILITY TO PREDICT OUTCOMES. 2104 01:35:21,846 --> 01:35:25,984 NFL FOR US WAS THE STRONGEST 2105 01:35:25,984 --> 01:35:28,286 PREDICTOR OF COGNITION CROSS 2106 01:35:28,286 --> 01:35:31,389 SECTIONALLY AND LONGITUDINAL TO 2107 01:35:31,389 --> 01:35:34,292 PREDICT DEMENTIA ONSET BUT AS 2108 01:35:34,292 --> 01:35:37,262 ROB MENTIONED THE STRENGTH OF 2109 01:35:37,262 --> 01:35:39,697 THE BIOMARKERS IS TO HELP 2110 01:35:39,697 --> 01:35:40,865 DIFFERENTIATE BETWEEN DIFFERENT 2111 01:35:40,865 --> 01:35:43,101 KINDS OF DEMENTIAS. 2112 01:35:43,101 --> 01:35:44,602 WE HAVE MEASURED THESE 2113 01:35:44,602 --> 01:35:46,671 LONGITUDINALLY AND MEASUREMENTS 2114 01:35:46,671 --> 01:35:47,972 SIX YEARS LATER NOW AND JUST 2115 01:35:47,972 --> 01:35:51,242 STARTING TO LOOK AT THOSE AND 2116 01:35:51,242 --> 01:35:52,177 THINK THAT WILL HELPFUL IN 2117 01:35:52,177 --> 01:35:52,844 UNDERSTANDING HOW THEY CHANGE 2118 01:35:52,844 --> 01:35:53,311 OVER TIME. 2119 01:35:53,311 --> 01:35:56,681 ONE THING WE NEED IN THE FIELD 2120 01:35:56,681 --> 01:35:57,949 IS A PLATFORM COMPARISON. 2121 01:35:57,949 --> 01:35:58,716 WE'RE ALL USING DIFFERENT TYPES 2122 01:35:58,716 --> 01:35:59,684 OF TECHNIQUES TO MEASURE THESE 2123 01:35:59,684 --> 01:36:03,488 THINGS AND I THINK FOR US TO 2124 01:36:03,488 --> 01:36:05,023 BEGIN TO UNDERSTAND HOW ALL OF 2125 01:36:05,023 --> 01:36:06,257 THESE STUDY RELATE TO ONE 2126 01:36:06,257 --> 01:36:08,259 ANOTHER THAT TYPE OF WORK WOULD 2127 01:36:08,259 --> 01:36:08,760 BE HELPFUL. 2128 01:36:08,760 --> 01:36:10,695 I ALSO WANTED TO MAKE A PLUG 2129 01:36:10,695 --> 01:36:13,731 THAT ALL THE DATA WE PRODUCE ARE 2130 01:36:13,731 --> 01:36:14,065 PUBLICALLY -- 2131 01:36:14,065 --> 01:36:18,603 [NO AUDIO] 2132 01:36:18,603 --> 01:36:29,047 RELEASED LATER THIS YEAR. 2133 01:36:36,287 --> 01:36:38,189 >> I'LL TRY THAT AGAIN. 2134 01:36:38,189 --> 01:36:42,694 >> I WANT TO START BY THANKING 2135 01:36:42,694 --> 01:36:48,633 THE NIA FOR THE SIN INVITATION. 2136 01:36:48,633 --> 01:36:52,003 WE HAVE A NON FOR PROFIT TO 2137 01:36:52,003 --> 01:36:54,572 SUPPORT THE MISSION OF THE NIH 2138 01:36:54,572 --> 01:36:57,075 AND ONE OF THE KEY SUCCESSES IN 2139 01:36:57,075 --> 01:36:58,710 TACKLING THE MOST PRESSING 2140 01:36:58,710 --> 01:37:02,180 HEALTH CHALLENGES IS PARTNERING 2141 01:37:02,180 --> 01:37:06,684 WITH WORLD CLASS ORGANIZATIONS 2142 01:37:06,684 --> 01:37:11,055 AND SCIENTIST AND CREATES 2143 01:37:11,055 --> 01:37:12,290 PUBLIC-PRIVATE PARTNERSHIPS AND 2144 01:37:12,290 --> 01:37:16,828 ADVOCACY GROUPS TO ACCELERATE 2145 01:37:16,828 --> 01:37:17,695 BIOMEDICAL INNOVATION ACROSS A 2146 01:37:17,695 --> 01:37:19,864 RANGE OF DISEASES. 2147 01:37:19,864 --> 01:37:23,067 AND THE FNIH HAS LED SEVERAL 2148 01:37:23,067 --> 01:37:25,803 INITIATIVES RESPONSIVE TO THE 2149 01:37:25,803 --> 01:37:26,704 UNMET NEEDS IN ALZHEIMER'S 2150 01:37:26,704 --> 01:37:28,573 DISEASE RESEARCH AND IN LINE 2151 01:37:28,573 --> 01:37:32,043 WITH PET TRACERS, FLUID 2152 01:37:32,043 --> 01:37:33,645 BIOMARKERS AND THE DISEASE 2153 01:37:33,645 --> 01:37:35,180 MODIFYING THERAPEUTICS RECENTLY. 2154 01:37:35,180 --> 01:37:42,687 THESE INCLUDE OVERSIGHTS OF THE 2155 01:37:42,687 --> 01:37:52,764 AD 2156 01:38:00,672 --> 01:38:00,939 AD 2157 01:38:00,939 --> 01:38:01,573 ADNI PUBLIC-PRIVATE PARTNERSHIPS 2158 01:38:01,573 --> 01:38:02,473 AND WITH THE CONSORTIUM IN I AM 2159 01:38:02,473 --> 01:38:03,942 PROVING HEALTH THROUGH MEASURES. 2160 01:38:03,942 --> 01:38:05,710 WE LEAD A CROSS-SECTOR EFFORTS 2161 01:38:05,710 --> 01:38:08,346 TO IDENTIFY AND VALIDATE AND 2162 01:38:08,346 --> 01:38:09,480 QUALIFY POTENTIAL BIOMARKERS TO 2163 01:38:09,480 --> 01:38:11,816 ADVANCE DRUG DEVELOPMENT AND 2164 01:38:11,816 --> 01:38:16,654 ALSO SUPPORT REGULATORY DECISION 2165 01:38:16,654 --> 01:38:16,921 MAKING. 2166 01:38:16,921 --> 01:38:19,624 AMONG THE GOALS ARE TO DEVELOP 2167 01:38:19,624 --> 01:38:20,291 EVIDENCE TO QUALIFY BIOMARKERS 2168 01:38:20,291 --> 01:38:28,766 FOR SPECIFIC APPLICATIONS IN 2169 01:38:28,766 --> 01:38:31,703 DIAGNOSING DISEASE AND IMPROVING 2170 01:38:31,703 --> 01:38:32,570 CLINI 2171 01:38:32,570 --> 01:38:34,205 CLINICAL PRACTICE AND WITHIN THE 2172 01:38:34,205 --> 01:38:35,573 THEMES OF THE SUMMIT IS THAT THE 2173 01:38:35,573 --> 01:38:38,676 DATA THAT IS GENERATED OR 2174 01:38:38,676 --> 01:38:42,180 FINDINGS GENERATED WITHIN THE 2175 01:38:42,180 --> 01:38:45,016 BIOMARKER CONSORTIUM PROJECT ARE 2176 01:38:45,016 --> 01:38:46,084 MADE BROADLY AVAILABLE TO THE 2177 01:38:46,084 --> 01:38:47,085 SCIENTIFIC COMMUNITY. 2178 01:38:47,085 --> 01:38:48,620 THERE ARE FOUR THERAPEUTIC AREAS 2179 01:38:48,620 --> 01:38:49,921 UNDER THE BIOMARKER CONSORTIUM 2180 01:38:49,921 --> 01:38:52,824 BUT FOR THE PURPOSES OF MY 2181 01:38:52,824 --> 01:38:54,359 PRESENTATION I'LL FOCUS ON OUR 2182 01:38:54,359 --> 01:38:56,694 NEUROSCIENCE COMMITTEE WHICH IS 2183 01:38:56,694 --> 01:39:00,698 COMPRISED OF REPRESENTS FROM THE 2184 01:39:00,698 --> 01:39:03,635 NIH, FDA, BIO TECHNOLOGY AND BIO 2185 01:39:03,635 --> 01:39:05,236 PHARMACEUTICAL COMPANIES AND 2186 01:39:05,236 --> 01:39:07,105 PATIENT ADVOCACY ORGANIZATIONS. 2187 01:39:07,105 --> 01:39:13,444 THE FNIH HAS CONCEPT IDEATION TO 2188 01:39:13,444 --> 01:39:14,579 COMPREHENSIVE PROJECT PLANNING 2189 01:39:14,579 --> 01:39:15,513 AND THROUGH PROJECT EXECUTION. 2190 01:39:15,513 --> 01:39:18,383 SO WE HAVE A NUMBER OF ACTIVE 2191 01:39:18,383 --> 01:39:21,219 PROJECTS THAT ARE INVESTIGATING 2192 01:39:21,219 --> 01:39:22,687 ANALYTICAL VALIDATION OF FLUID 2193 01:39:22,687 --> 01:39:23,788 AND IMAGING BIOMARKERS AND FOR 2194 01:39:23,788 --> 01:39:25,823 THE INTEREST OF TIME I DO 2195 01:39:25,823 --> 01:39:30,261 ENCOURAGE YOU TO UTILIZE THAT QR 2196 01:39:30,261 --> 01:39:33,998 CODE TAKING US TO THE BIOMARKER 2197 01:39:33,998 --> 01:39:34,499 CONSORTIUM WEBSITE FOR 2198 01:39:34,499 --> 01:39:35,500 INFORMATION ON THE PROJECTS. 2199 01:39:35,500 --> 01:39:40,038 AND I DID WANT TO MENTION TOO 2200 01:39:40,038 --> 01:39:40,571 THE NEUROSCIENCE STEERING 2201 01:39:40,571 --> 01:39:43,141 COMMITTEE IS ENGAGED IN 2202 01:39:43,141 --> 01:39:44,075 PRIORITIZING AND OUTLINE NEW 2203 01:39:44,075 --> 01:39:45,376 PROJECT CONCEPTS DONE IN THE 2204 01:39:45,376 --> 01:39:49,047 COMING MONTHS AND A FEW OF THE 2205 01:39:49,047 --> 01:39:49,781 POTENTIAL AREAS THROUGH 2206 01:39:49,781 --> 01:39:50,982 DISCUSSIONS WITH OUR PARTNERS 2207 01:39:50,982 --> 01:39:54,285 THAT HAVE BEEN HIGHLIGHTED FOR 2208 01:39:54,285 --> 01:39:56,454 NEURAL INFLAMMATION, DIGITAL 2209 01:39:56,454 --> 01:40:01,726 MEASURES AND TDP43 AND I WANTED 2210 01:40:01,726 --> 01:40:04,162 TO TOUCH ON IN DEVELOPMENT 2211 01:40:04,162 --> 01:40:05,063 PROJECTS. 2212 01:40:05,063 --> 01:40:10,134 THE FIRST BEING THE AD BIO 2213 01:40:10,134 --> 01:40:11,469 SIGNATURE PROJECT AND A 2214 01:40:11,469 --> 01:40:17,075 SIGNATURE OF AMYLOID POSITIVE 2215 01:40:17,075 --> 01:40:20,178 COHORTS OF M INDIVIDUALS. 2216 01:40:20,178 --> 01:40:23,381 THE IDEA WE WOULD LEVERAGE DATA 2217 01:40:23,381 --> 01:40:25,483 EXISTING WITHIN PRE CLINICAL AND 2218 01:40:25,483 --> 01:40:28,319 AD COHORTS WITH A FOCUS ON 2219 01:40:28,319 --> 01:40:31,022 DIVERSITY WITHIN THE SELECTION 2220 01:40:31,022 --> 01:40:32,957 OF PARTICIPANTS, PERFORM 2221 01:40:32,957 --> 01:40:34,459 ADDITIONAL BIOMARKER ASSESSMENTS 2222 01:40:34,459 --> 01:40:37,261 TO FILL IN ANY DATA GAPS, 2223 01:40:37,261 --> 01:40:40,031 HARMONIZE TO THE POINT MADE OF 2224 01:40:40,031 --> 01:40:45,603 DIFFERENT PLATFORMS AND 2225 01:40:45,603 --> 01:40:52,243 INVESTIGATE EMERGING BLOOD 2226 01:40:52,243 --> 01:40:53,044 BASED BIOMARKERS. 2227 01:40:53,044 --> 01:40:53,911 IF YOU WAND MORE INFORMATION 2228 01:40:53,911 --> 01:40:55,213 COME FIND ME. 2229 01:40:55,213 --> 01:40:56,614 YOU HAVE MY E-MAIL IF YOU'D LIKE 2230 01:40:56,614 --> 01:40:59,917 TO CONNECT OUTSIDE THE SUMMIT 2231 01:40:59,917 --> 01:41:05,089 AND I'LL END BY BRIEFLY 2232 01:41:05,089 --> 01:41:09,460 INTRODUCING OUR WORK TO 2233 01:41:09,460 --> 01:41:10,695 COMPREHENSIVELY INVESTIGATE THE 2234 01:41:10,695 --> 01:41:13,064 CLINICAL RELEVANCE AND 2235 01:41:13,064 --> 01:41:14,699 BIOLOGICAL CONTEXT OF VARIOUS 2236 01:41:14,699 --> 01:41:17,068 SYNAPTIC MARKERS IN ALZHEIMER'S 2237 01:41:17,068 --> 01:41:18,903 DISEASE AND PSYCHOSIS SPECTRUM 2238 01:41:18,903 --> 01:41:20,972 DISORDERS AND ELUCIDATING THEIR 2239 01:41:20,972 --> 01:41:22,640 ASSOCIATION WITH DISEASE 2240 01:41:22,640 --> 01:41:23,241 PATHOLOGY. 2241 01:41:23,241 --> 01:41:26,677 THAT WILL ENTAIL META-ANALYSIS 2242 01:41:26,677 --> 01:41:27,645 AS WELL AS COMPARISONS BETWEEN 2243 01:41:27,645 --> 01:41:30,681 THE FLUID SYNAPTIC MARKERS AND 2244 01:41:30,681 --> 01:41:32,550 VALIDATING THEM AGAINST PET 2245 01:41:32,550 --> 01:41:36,921 IMAGING AND MEASUREMENTS IN 2246 01:41:36,921 --> 01:41:37,255 BRAIN TISSUE. 2247 01:41:37,255 --> 01:41:38,956 YOU ENCOURAGE TO YOU REACH OUT 2248 01:41:38,956 --> 01:41:41,526 KNOW COLLEGIATE THE FNIH AND HER 2249 01:41:41,526 --> 01:41:42,827 E-MAIL IS HERE IF YOU ARE 2250 01:41:42,827 --> 01:41:43,127 INTERESTED. 2251 01:41:43,127 --> 01:41:51,602 THANK YOU SO MUCH. 2252 01:41:51,602 --> 01:41:53,004 >> OKAY. 2253 01:41:53,004 --> 01:41:56,374 SO I THINK WE DID A GREAT JOB ON 2254 01:41:56,374 --> 01:41:58,443 TIME WITH THAT SESSION. 2255 01:41:58,443 --> 01:42:03,714 SO TO KICK OFF THE DISCUSSION 2256 01:42:03,714 --> 01:42:04,949 PORTION OF THIS SESSION 2257 01:42:04,949 --> 01:42:09,654 DR. RHODA AU AND I PRIMARILY 2258 01:42:09,654 --> 01:42:11,756 RHODA PUT TOGETHER SOME TALKING 2259 01:42:11,756 --> 01:42:13,324 POINTS FOR US TO THINK ABOUT 2260 01:42:13,324 --> 01:42:18,196 WHEN WE THINK ABOUT GAPS IN 2261 01:42:18,196 --> 01:42:19,530 OPPORTUNITIES AND WITH RESPECT 2262 01:42:19,530 --> 01:42:22,467 TO DISCOVERY I THINK THE THEMES 2263 01:42:22,467 --> 01:42:24,035 THAT CAME ACROSS TODAY FROM ALL 2264 01:42:24,035 --> 01:42:26,370 OF OUR SPEAKERS ARE THAT WE NEED 2265 01:42:26,370 --> 01:42:30,975 TO DIVERSIFY AND IDENTIFY NOVEL 2266 01:42:30,975 --> 01:42:31,876 BIOMARKERS, NEXT GENERATION 2267 01:42:31,876 --> 01:42:34,512 BIOMARKERS AND WE NEED TO BE 2268 01:42:34,512 --> 01:42:36,047 REPRESENTATIVE IN OUR SAMPLE 2269 01:42:36,047 --> 01:42:40,117 WHEN WE ARE LOOKING AT 2270 01:42:40,117 --> 01:42:41,052 BIOMARKERS. 2271 01:42:41,052 --> 01:42:43,221 WE ALSO NEED CLEAR VALIDATION 2272 01:42:43,221 --> 01:42:46,457 AND I THINK JESSICA BROUGHT THIS 2273 01:42:46,457 --> 01:42:47,692 UP WE'RE ALL USING DIFFERENT 2274 01:42:47,692 --> 01:42:49,827 PLATFORMS TO MEASURE OUR PLASMA 2275 01:42:49,827 --> 01:42:53,297 BIOMARKERS WHEN WE'RE WORKING IN 2276 01:42:53,297 --> 01:42:53,965 INDIVIDUAL GROUPS. 2277 01:42:53,965 --> 01:42:59,070 WE'VE GOT TO MAKE SURE THAT'S 2278 01:42:59,070 --> 01:42:59,403 REPRODUCIBLE. 2279 01:42:59,403 --> 01:43:02,206 IT'S GOOD TO DO INDIVIDUAL WORK 2280 01:43:02,206 --> 01:43:05,810 BUT WE THESE MULTI-MODAL 2281 01:43:05,810 --> 01:43:07,011 VALIDATION ACROSS DIFFERENT 2282 01:43:07,011 --> 01:43:10,047 PLATFORMS TO REALLY VALIDATE 2283 01:43:10,047 --> 01:43:11,048 THESE BIOMARKERS BEFORE WE ROLL 2284 01:43:11,048 --> 01:43:12,717 THEM OUT IN CLINIC. 2285 01:43:12,717 --> 01:43:15,820 THE EXPOSOME I THINK HAS BEEN 2286 01:43:15,820 --> 01:43:18,689 DISCUSSED BY SEVERAL SPEAKERS. 2287 01:43:18,689 --> 01:43:20,558 WE KNOW IT'S CONTRIBUTORY BUT I 2288 01:43:20,558 --> 01:43:22,159 THINK WE NEED TO CONSIDER 2289 01:43:22,159 --> 01:43:26,697 EXPOSOME AS INTEGRATIVE AND 2290 01:43:26,697 --> 01:43:29,600 MULTIDIMENSIONAL AND THINK OF 2291 01:43:29,600 --> 01:43:34,639 THE CLINICAL UTILITY OF OUR 2292 01:43:34,639 --> 01:43:35,273 BIOMARKERS FOR DIAGNOSIS AND 2293 01:43:35,273 --> 01:43:37,074 CONSIDER HOW WE'LL GET THEM TO 2294 01:43:37,074 --> 01:43:38,643 FDA APPROVAL AND THEN HOW ARE WE 2295 01:43:38,643 --> 01:43:40,811 GOING TO INTEGRATE THEM AND 2296 01:43:40,811 --> 01:43:43,314 WHERE ARE WE GOING TO INTEGRATE 2297 01:43:43,314 --> 01:43:48,452 THEM WITHIN THE HEALTH CARE 2298 01:43:48,452 --> 01:43:48,953 SYSTEM. 2299 01:43:48,953 --> 01:43:51,522 THE OPPORTUNITIES ARE SCALABLE 2300 01:43:51,522 --> 01:43:52,757 ACCURATE ASSESSMENT AND 2301 01:43:52,757 --> 01:43:53,791 BIOMARKERS REPRESENT SUCH AN 2302 01:43:53,791 --> 01:43:55,326 OPPORTUNITY IN THIS AREA FOR US 2303 01:43:55,326 --> 01:43:59,063 TO BE SCALABLE AND ALSO 2304 01:43:59,063 --> 01:44:01,532 INCLUSIVE IN OUR SCIENCE AND 2305 01:44:01,532 --> 01:44:02,166 CARE. 2306 01:44:02,166 --> 01:44:07,238 AND WE NEED TO BE DOING TRUE 2307 01:44:07,238 --> 01:44:10,675 COMPREHENSIVE CHARACTERIZATION 2308 01:44:10,675 --> 01:44:13,544 OF BIOMARKERS. 2309 01:44:13,544 --> 01:44:15,813 SO GAP AND OPPORTUNITIES WITH 2310 01:44:15,813 --> 01:44:20,785 THE SCIENTIFIC ENGINE. 2311 01:44:20,785 --> 01:44:23,220 THE FRONT END INFRASTRUCTURE 2312 01:44:23,220 --> 01:44:26,457 LOW-COST DATA COLLECTION IS 2313 01:44:26,457 --> 01:44:26,691 IDEAL. 2314 01:44:26,691 --> 01:44:29,060 WE NEED DATA INGESTION AND NEED 2315 01:44:29,060 --> 01:44:30,695 TO BE WORK WITH THE FDA AS EARLY 2316 01:44:30,695 --> 01:44:33,898 AS POSSIBLE TO REALLY MOVE THESE 2317 01:44:33,898 --> 01:44:36,300 BIOMARKERS FORWARD TO THE 2318 01:44:36,300 --> 01:44:36,601 CLINIC. 2319 01:44:36,601 --> 01:44:40,504 ON THE BACK HAND WE NEED DATA 2320 01:44:40,504 --> 01:44:41,939 PREPARATION, DATA 2321 01:44:41,939 --> 01:44:45,276 DEIDENTIFICATION, DATA 2322 01:44:45,276 --> 01:44:47,912 HARMONIZATION IS KEY FOR SO MANY 2323 01:44:47,912 --> 01:44:51,282 OF THESE STUDIES. 2324 01:44:51,282 --> 01:44:53,651 DATA SHARING AND RE-USE I THINK 2325 01:44:53,651 --> 01:44:55,019 WE'RE ALL IN AGREEMENT. 2326 01:44:55,019 --> 01:44:58,689 OPEN DATA SHARING IS THE WAY 2327 01:44:58,689 --> 01:45:00,424 FORWARD FOR THE WHOLE FIELD. 2328 01:45:00,424 --> 01:45:02,693 SO WE NEED TO THINK IN THOSE 2329 01:45:02,693 --> 01:45:02,893 TERMS. 2330 01:45:02,893 --> 01:45:06,097 WE NEED TO THINK ABOUT HOW WE 2331 01:45:06,097 --> 01:45:07,498 CONSENT OUR PARTICIPANTS. 2332 01:45:07,498 --> 01:45:09,300 WE NEED TO THINK ABOUT THE 2333 01:45:09,300 --> 01:45:11,402 ETHICS OF THE DATA SHARING AND 2334 01:45:11,402 --> 01:45:12,870 CLINICAL STUDIES AND TRIALS. 2335 01:45:12,870 --> 01:45:13,738 I KNOW THERE'S BEEN A LOT OF 2336 01:45:13,738 --> 01:45:17,041 FRUSTRATION FROM THE ACADEMIC 2337 01:45:17,041 --> 01:45:20,011 COMMUNITY ABOUT ACCESS TO 2338 01:45:20,011 --> 01:45:22,580 SAMPLES FROM CLINICAL TRIALS SO 2339 01:45:22,580 --> 01:45:26,017 WE CAN APPLY OUR OWN SCIENTIFIC 2340 01:45:26,017 --> 01:45:27,752 HYPOTHESES AND MOVE THOSE FIELDS 2341 01:45:27,752 --> 01:45:27,985 FORWARD. 2342 01:45:27,985 --> 01:45:32,256 I THINK IF WE HAD SOME MORE OPEN 2343 01:45:32,256 --> 01:45:34,558 SCIENCE AROUND CLINICAL TRIALS 2344 01:45:34,558 --> 01:45:38,696 THAT WOULD MOVE THE SCIENCE MORE 2345 01:45:38,696 --> 01:45:38,929 RAPIDLY. 2346 01:45:38,929 --> 01:45:40,297 INTEROPERABILITY IS IMPORTANT. 2347 01:45:40,297 --> 01:45:42,700 ON THE DATA ANALYTICS SIDE AS WE 2348 01:45:42,700 --> 01:45:45,136 GET THESE BIG DATA SETS IT'S 2349 01:45:45,136 --> 01:45:47,071 GOING TO BE MULTI-DIMENSIONAL 2350 01:45:47,071 --> 01:45:47,471 DATA. 2351 01:45:47,471 --> 01:45:48,639 WE'LL HAVE A LOT OF MODELLING 2352 01:45:48,639 --> 01:45:52,677 AND CLEARLY THERE'S A SPACE HERE 2353 01:45:52,677 --> 01:45:55,212 FOR THE USE OF A.I. AND 2354 01:45:55,212 --> 01:45:58,749 OBVIOUSLY WE NEED TO RAMP UP OUR 2355 01:45:58,749 --> 01:46:03,721 DATA SCIENTIST WORKFORCE WHO CAN 2356 01:46:03,721 --> 01:46:05,423 SPEAK ALZHEIMER'S AND DEMENTIA. 2357 01:46:05,423 --> 01:46:06,691 THAT'S BEEN A CHALLENGE IS 2358 01:46:06,691 --> 01:46:10,728 FINDING DATA SCIENTISTS WHO CAN 2359 01:46:10,728 --> 01:46:14,699 HAVE ENOUGH UNDERSTANDING OF THE 2360 01:46:14,699 --> 01:46:17,034 SCIENCE WE'RE TRYING TO DO. 2361 01:46:17,034 --> 01:46:19,770 WE HAVE A LOT OF OPPORTUNITIES. 2362 01:46:19,770 --> 01:46:22,440 THERE'S A LOT OF NON-PROPRIETARY 2363 01:46:22,440 --> 01:46:24,008 TOOL AND YOU DON'T HAVE TO BUY 2364 01:46:24,008 --> 01:46:25,376 LICENSE AND EXPENSIVE SOFTWARE 2365 01:46:25,376 --> 01:46:26,711 TO DO SOME OF THIS WORK. 2366 01:46:26,711 --> 01:46:28,479 AND MANY PEOPLE ARE PUTTING 2367 01:46:28,479 --> 01:46:30,648 THEIR DATA ANALYTIC CODES OUT 2368 01:46:30,648 --> 01:46:33,150 ONLINE SO YOU CAN REPRODUCE 2369 01:46:33,150 --> 01:46:35,686 THEIR ANALYSIS ON YOUR OWN DATA 2370 01:46:35,686 --> 01:46:36,253 SETS. 2371 01:46:36,253 --> 01:46:39,724 WE NEED ACCESSIBLE AND GLOBALLY 2372 01:46:39,724 --> 01:46:41,559 REPRESENTATIVE DATA RESOURCES 2373 01:46:41,559 --> 01:46:46,731 AND I THANK THE NIH FOR TRYING 2374 01:46:46,731 --> 01:46:48,232 TO BUILD A LOT OF THESE 2375 01:46:48,232 --> 01:46:50,735 INTERNATIONAL AS WELL AS 2376 01:46:50,735 --> 01:46:51,736 NATIONAL REPOSITORIES. 2377 01:46:51,736 --> 01:46:53,437 WE NEED TO ADVANCE COMPUTATIONAL 2378 01:46:53,437 --> 01:46:55,339 APPROACHES AND I SEE THIS AS 2379 01:46:55,339 --> 01:46:57,208 BEING A RAPIDLY ACCELERATING 2380 01:46:57,208 --> 01:46:59,143 AREA OVER THE NEXT FEW YEARS. 2381 01:46:59,143 --> 01:46:59,677 WE NEED EQUAL OPPORTUNITY 2382 01:46:59,677 --> 01:47:02,680 SCIENCE. 2383 01:47:02,680 --> 01:47:05,116 SO WITH THAT AND WITH THOSE 2384 01:47:05,116 --> 01:47:07,084 BROAD GAPS IN OPPORTUNITIES WHEN 2385 01:47:07,084 --> 01:47:09,954 IT COMES TO BIOMARKERS WE'LL 2386 01:47:09,954 --> 01:47:12,156 OPEN THIS UP FOR A DISCUSSION 2387 01:47:12,156 --> 01:47:14,425 WITHIN THE PANEL BUT ALSO 2388 01:47:14,425 --> 01:47:15,926 OBVIOUSLY IDEALLY WE WOULD HAVE 2389 01:47:15,926 --> 01:47:17,828 QUESTIONS FROM THE AUDIENCE. 2390 01:47:17,828 --> 01:47:18,963 PLEASE COME TO THE MICROPHONES 2391 01:47:18,963 --> 01:47:19,930 WITH ANY QUESTIONS OR POINTS 2392 01:47:19,930 --> 01:47:30,274 YOU'D LIKE TO MAKE. 2393 01:47:32,676 --> 01:47:34,345 >> HI THERE. 2394 01:47:34,345 --> 01:47:35,012 SOME MIND BLOWING PRESENTATIONS 2395 01:47:35,012 --> 01:47:38,149 THIS MORNING. 2396 01:47:38,149 --> 01:47:42,720 MY QUESTION DIRECTED TO THE 2397 01:47:42,720 --> 01:47:47,091 ONES -- PLEASE DON'T TAKE THIS 2398 01:47:47,091 --> 01:47:53,764 PERSONALLY AND MIKE SNYDER AND 2399 01:47:53,764 --> 01:47:56,500 RHODA AU AND THE DIGITAL 2400 01:47:56,500 --> 01:47:56,801 BIOMARKERS. 2401 01:47:56,801 --> 01:47:59,537 THE CAPABILITIES AND POTENTIAL 2402 01:47:59,537 --> 01:48:02,406 IS AMAZING BUT WONDERING IF YOU 2403 01:48:02,406 --> 01:48:04,542 MIGHT BE WILLING THERE'S A 2404 01:48:04,542 --> 01:48:05,376 DIFFERENCE BETWEEN RESEARCH AND 2405 01:48:05,376 --> 01:48:06,744 CLINICAL PRACTICE. 2406 01:48:06,744 --> 01:48:11,015 BIG DIFFERENCE. 2407 01:48:11,015 --> 01:48:14,251 COULD YOU ADDRESS, PLEASE, THE 2408 01:48:14,251 --> 01:48:19,924 ISSUES OF THE RISKS, SAFETY AND 2409 01:48:19,924 --> 01:48:20,157 PRIVACY? 2410 01:48:20,157 --> 01:48:22,726 >> WHO WOULD LIKE TO TAKE THAT 2411 01:48:22,726 --> 01:48:32,603 QUESTION? 2412 01:48:32,603 --> 01:48:33,170 >> THANK YOU. 2413 01:48:33,170 --> 01:48:36,106 I THINK ABOUT PRIVACY, GET OVER 2414 01:48:36,106 --> 01:48:36,273 IT. 2415 01:48:36,273 --> 01:48:37,341 NOTHING'S REALLY PRIVATE. 2416 01:48:37,341 --> 01:48:38,709 YOU HAVE CAMERAS ON TRAFFIC 2417 01:48:38,709 --> 01:48:39,009 LIGHTS. 2418 01:48:39,009 --> 01:48:44,048 WE ALL HAVE CREDIT CARDS AND 2419 01:48:44,048 --> 01:48:48,385 THEY'RE HAVE PRIVATE INFORMATION 2420 01:48:48,385 --> 01:48:49,453 IS THE ANSWER BY THE WAY AND 2421 01:48:49,453 --> 01:48:52,189 THERE'S PRIVATE DATA OUT THERE 2422 01:48:52,189 --> 01:48:54,892 AND THE QUESTION IS WE'LL GET 2423 01:48:54,892 --> 01:48:57,528 THEM USED AND OBVIOUSLY MY 2424 01:48:57,528 --> 01:49:02,600 THINKING IS WE SHOULD HAVE LAWS 2425 01:49:02,600 --> 01:49:05,169 AND WE WANT TO PROMOTE DATA. 2426 01:49:05,169 --> 01:49:07,538 I THINK DATA ARE INCREDIBLY 2427 01:49:07,538 --> 01:49:07,805 VALUABLE. 2428 01:49:07,805 --> 01:49:11,308 IT'S A LOT OF WORK ACTUALLY TO 2429 01:49:11,308 --> 01:49:12,743 GO THROUGH ALL THESE PRIVACIES 2430 01:49:12,743 --> 01:49:13,878 TO RUN THE STUDIES BECAUSE 2431 01:49:13,878 --> 01:49:16,080 PEOPLE ARE VERY CONCERNED BUT I 2432 01:49:16,080 --> 01:49:18,716 CAN'T SAY I'VE NEVER SEEN ANYONE 2433 01:49:18,716 --> 01:49:21,252 WHO'S BEEN ABUSED BY THEIR 2434 01:49:21,252 --> 01:49:21,919 WEARABLE DATA. 2435 01:49:21,919 --> 01:49:24,788 I MAY BE WRONG ABOUT THAT BUT I 2436 01:49:24,788 --> 01:49:26,357 HAVEN'T SEEN IT MUCH AND THE 2437 01:49:26,357 --> 01:49:27,358 BENEFITS OUT WEIGH THE RISK. 2438 01:49:27,358 --> 01:49:31,395 I GUESS I'M SAYING I THINK THE 2439 01:49:31,395 --> 01:49:33,330 DATA IS SUPER VALUABLE. 2440 01:49:33,330 --> 01:49:34,665 SOME ARE QUITE ACCURATE. 2441 01:49:34,665 --> 01:49:37,401 SOME LESS SO BUT THE DELTAS ARE 2442 01:49:37,401 --> 01:49:39,236 USUALLY FINE WITH CHANGES. 2443 01:49:39,236 --> 01:49:42,773 I JUST THINK IT'S INCREDIBLY 2444 01:49:42,773 --> 01:49:45,776 VALUABLE THINGS TO BRING IN. 2445 01:49:45,776 --> 01:49:47,978 I THINK WE CAN SECURE AS MUCH AS 2446 01:49:47,978 --> 01:49:50,381 WE CAN AND GENOMIC DATA AND FIRE 2447 01:49:50,381 --> 01:49:53,117 WALLS AND ALL THIS SORT OF 2448 01:49:53,117 --> 01:49:53,684 STUFF. 2449 01:49:53,684 --> 01:49:55,586 HOPEFULLY IT WON'T BE ABUSED BUT 2450 01:49:55,586 --> 01:49:58,422 NOTHING IS TOTALLY UNHACKABLE. 2451 01:49:58,422 --> 01:50:00,724 SO I THINK AGAIN THE BENEFITS 2452 01:50:00,724 --> 01:50:02,559 OUTWEIGH THE RISKS. 2453 01:50:02,559 --> 01:50:05,296 I MYSELF AS A PERSONAL LEVEL 2454 01:50:05,296 --> 01:50:07,765 HAVE ABOUT TWO PETABYTES OF MY 2455 01:50:07,765 --> 01:50:09,867 DATA ONLINE INCLUDING ANY GENOME 2456 01:50:09,867 --> 01:50:12,436 SEQUENCE AND SO FAR NO ONE HAS 2457 01:50:12,436 --> 01:50:15,472 ABUSED ME FOR IT AND I'VE GOTTEN 2458 01:50:15,472 --> 01:50:16,307 INTERESTING ADVICE OUT THERE BUT 2459 01:50:16,307 --> 01:50:18,442 THAT'S MY TWO CENTS ON IT. 2460 01:50:18,442 --> 01:50:22,579 >> I ASSUME YOU HAVEN'T APPLIED 2461 01:50:22,579 --> 01:50:24,481 FOR LONG-TERM CARE YET? 2462 01:50:24,481 --> 01:50:26,917 >> NOT YET. 2463 01:50:26,917 --> 01:50:28,652 >> THIS IS AN EXAMPLE OF ONE OF 2464 01:50:28,652 --> 01:50:29,386 THE RISKS. 2465 01:50:29,386 --> 01:50:33,857 >> IT COULD BE, YEAH. 2466 01:50:33,857 --> 01:50:34,725 >> IPSIT DO YOU HAVE ANYTHING TO 2467 01:50:34,725 --> 01:50:40,230 ADD TO THIS DISCUSSION? 2468 01:50:40,230 --> 01:50:42,733 >> AS SOMEONE WHO GIVES MY 2469 01:50:42,733 --> 01:50:45,436 PATIENTS WEARABLES THIS IS WITH 2470 01:50:45,436 --> 01:50:49,473 MY CLINICIAN HAT ON, 2471 01:50:49,473 --> 01:50:50,407 TRANSPARENCY IS KEY AND 2472 01:50:50,407 --> 01:50:53,110 ENGENDERS TRUST AND IF YOU CAN 2473 01:50:53,110 --> 01:50:55,045 TELL SOMEONE EXACTLY WHAT YOU'RE 2474 01:50:55,045 --> 01:50:57,314 COLLECTING AND CAN CONTROL AND 2475 01:50:57,314 --> 01:50:58,682 CAN'T CONTROL AND EXPLAIN WHAT 2476 01:50:58,682 --> 01:51:00,584 THEY'RE GOING TO GET OUT OF IT, 2477 01:51:00,584 --> 01:51:02,086 I THINK PEOPLE ARE QUITE WILLING 2478 01:51:02,086 --> 01:51:04,188 TO SHARE THEIR DATA IF YOU CAN 2479 01:51:04,188 --> 01:51:05,556 CONVEY TO THEM EXACTLY HOW THIS 2480 01:51:05,556 --> 01:51:06,724 IS GOING TO HELP THEM. 2481 01:51:06,724 --> 01:51:10,494 THIS IS THE ONE-ON-ONE 2482 01:51:10,494 --> 01:51:11,095 DOCTOR-PATIENT LEVEL. 2483 01:51:11,095 --> 01:51:12,363 IT'S HARDER AT SCALE. 2484 01:51:12,363 --> 01:51:13,464 THE OTHER POINT IS THE QUALITY 2485 01:51:13,464 --> 01:51:16,467 OF DATA AND PRECISION YOU NEED 2486 01:51:16,467 --> 01:51:18,702 FOR CLINICAL PRACTICE IS QUITE A 2487 01:51:18,702 --> 01:51:20,170 LOWER STANDARD BAR THAN FOR 2488 01:51:20,170 --> 01:51:21,071 RESEARCH. 2489 01:51:21,071 --> 01:51:23,640 WE USE THE TERM DIGITAL 2490 01:51:23,640 --> 01:51:24,541 CO-LATERAL INFORMATION TO 2491 01:51:24,541 --> 01:51:27,444 CAPTURE WHAT WE DO WITH PATIENTS 2492 01:51:27,444 --> 01:51:28,645 WHERE YOU WANT ADDITIONAL 2493 01:51:28,645 --> 01:51:29,313 SOURCES OF INFORMATION. 2494 01:51:29,313 --> 01:51:30,748 THEY DON'T NEED TO BE PERFECT. 2495 01:51:30,748 --> 01:51:33,050 THE WORK OF CLINICAL PRACTICE 2496 01:51:33,050 --> 01:51:35,519 OFTEN COMES TO INTEGRATING 2497 01:51:35,519 --> 01:51:37,688 VARIOUS SOURCES OF DATA AND WHAT 2498 01:51:37,688 --> 01:51:40,357 THE PATIENT TELLS YOU TO GENETIC 2499 01:51:40,357 --> 01:51:45,763 MARKERS AND COMING UP WITH A 2500 01:51:45,763 --> 01:51:53,103 PLAN. 2501 01:51:53,103 --> 01:51:54,705 AND IN THE END WE HEARD TRUST IS 2502 01:51:54,705 --> 01:51:55,873 KEY. 2503 01:51:55,873 --> 01:51:58,709 >> RHODA ANYTHING TO ADD? 2504 01:51:58,709 --> 01:52:00,010 >> VALUE PROPOSITION IS WHAT 2505 01:52:00,010 --> 01:52:00,744 YOU'RE TALKING ABOUT. 2506 01:52:00,744 --> 01:52:02,346 YOU NEED TO GIVE VALUE BACK FROM 2507 01:52:02,346 --> 01:52:04,248 THE RESEARCH SAMPLING AND ALSO 2508 01:52:04,248 --> 01:52:05,616 ON THE CLINICAL STANDPOINT. 2509 01:52:05,616 --> 01:52:12,189 I DO THINK WE'RE GOING TO MOVE 2510 01:52:12,189 --> 01:52:17,127 TO A CASE WHERE OUR WEARABLE 2511 01:52:17,127 --> 01:52:27,604 APPLICATIONS WILL GIVE DATA. 2512 01:52:29,039 --> 01:52:30,641 FITBIT GIVES YOU STEPS AND SO 2513 01:52:30,641 --> 01:52:32,342 FORTH AND FROM A CLINICAL CARE 2514 01:52:32,342 --> 01:52:33,677 STANDPOINT I THINK WE'LL START 2515 01:52:33,677 --> 01:52:37,347 WITH THEM AS MEASURES NOT 2516 01:52:37,347 --> 01:52:38,182 BIOMARKERS. 2517 01:52:38,182 --> 01:52:40,984 I THINK THERE'S VALUE IN GETTING 2518 01:52:40,984 --> 01:52:41,785 THIS INFORMATION. 2519 01:52:41,785 --> 01:52:44,288 SHARING IT WITH YOUR CLINICAL 2520 01:52:44,288 --> 01:52:48,559 CARE TEAM WITH A LOWER LEVEL OF 2521 01:52:48,559 --> 01:52:50,194 ACCURACY DEPENDENCY AT THAT 2522 01:52:50,194 --> 01:52:50,727 POINT. 2523 01:52:50,727 --> 01:52:54,731 THAT'S WHY I DIFFERENTIATE 2524 01:52:54,731 --> 01:52:57,201 BETWEEN DIGITAL PHENOTYPING 2525 01:52:57,201 --> 01:52:58,001 MEASURES VERSUS BIOMARKERS WHICH 2526 01:52:58,001 --> 01:53:00,938 WILL TAKE US A KWLIEL TO GET 2527 01:53:00,938 --> 01:53:02,806 THERE BUT AT LEAST WE'LL BE ABLE 2528 01:53:02,806 --> 01:53:03,640 TO PENETRATE. 2529 01:53:03,640 --> 01:53:06,343 WE'RE ALREADY STARTING TO 2530 01:53:06,343 --> 01:53:07,344 PENETRATE WITH THE DIGITAL 2531 01:53:07,344 --> 01:53:08,078 DEVICES. 2532 01:53:08,078 --> 01:53:09,947 THE OTHER THING WE DO IS AT 2533 01:53:09,947 --> 01:53:11,582 LEAST IN THE RESEARCH WE'RE 2534 01:53:11,582 --> 01:53:12,816 DOING IS GIVING PARTICIPANTS A 2535 01:53:12,816 --> 01:53:13,750 CHOICE. 2536 01:53:13,750 --> 01:53:16,253 SO WE WILL HAVE A SET OF 2537 01:53:16,253 --> 01:53:18,355 DIFFERENT APPLICATIONS, 2538 01:53:18,355 --> 01:53:23,927 WEARABLES AND IN-HOME SENSOR AND 2539 01:53:23,927 --> 01:53:25,796 ALLOW THEM TO CHOOSE WHAT THEY 2540 01:53:25,796 --> 01:53:27,764 FEEL COMFORTABLE WITH TO GIVE 2541 01:53:27,764 --> 01:53:29,032 THEM THE VALUE PROPOSITION 2542 01:53:29,032 --> 01:53:30,667 THAT'S IMPORTANT TO THEM AND WE 2543 01:53:30,667 --> 01:53:32,536 MAKE SURE TO COLLECT THE RAW 2544 01:53:32,536 --> 01:53:34,605 DIGITAL DATA STREAMS. 2545 01:53:34,605 --> 01:53:38,509 IT TURNS OUT ACROSS ALL THESE 2546 01:53:38,509 --> 01:53:40,544 SMARTPHONE, WEARABLE, THEY'RE 2547 01:53:40,544 --> 01:53:42,546 ALL THE SAME SENSORS AND 2548 01:53:42,546 --> 01:53:44,081 COLLECTING THE SAME KIND OF DATA 2549 01:53:44,081 --> 01:53:46,717 JUST WITH DIFFERENT KINDS OF 2550 01:53:46,717 --> 01:53:47,851 DEVICES. 2551 01:53:47,851 --> 01:53:49,887 SO WE GET THE RAW IT'S GOING TO 2552 01:53:49,887 --> 01:53:51,155 BE OVERLAPPING. 2553 01:53:51,155 --> 01:53:52,422 SO THEY GET THEIR CHOICE IN 2554 01:53:52,422 --> 01:53:54,725 ORDER TO MAKE SURE IT BRINGS 2555 01:53:54,725 --> 01:53:57,027 VALUE TO THEM AND WE'RE GETTING 2556 01:53:57,027 --> 01:53:57,227 DATA. 2557 01:53:57,227 --> 01:53:59,096 THIS IS WHERE THE DATA 2558 01:53:59,096 --> 01:54:00,697 HARMONIZATION COMES IN TO 2559 01:54:00,697 --> 01:54:02,032 AGGREGATE AND GET TO THE SAME 2560 01:54:02,032 --> 01:54:05,102 MEASURES EVEN THOUGH IT'S COMING 2561 01:54:05,102 --> 01:54:07,104 FROM DIFFERENT SOURCES. 2562 01:54:07,104 --> 01:54:09,072 >> THANK YOU FOR YOUR THOUGHTFUL 2563 01:54:09,072 --> 01:54:09,806 RESPONSES. 2564 01:54:09,806 --> 01:54:11,575 LET'S KEEP THAT PART OF THE 2565 01:54:11,575 --> 01:54:12,309 DIALOGUE. 2566 01:54:12,309 --> 01:54:15,546 >> MICROPHONE TO MY RIGHT, 2567 01:54:15,546 --> 01:54:15,946 PLEASE. 2568 01:54:15,946 --> 01:54:20,050 >> YES, WONDERFUL PRESENTATIONS. 2569 01:54:20,050 --> 01:54:24,021 I ENJOYED IT SANDIN JONES. 2570 01:54:24,021 --> 01:54:25,489 I DRUTH THE CLINICAL BIOMARKERS 2571 01:54:25,489 --> 01:54:29,092 LABORATORY AND WHEN I STARTED IT 2572 01:54:29,092 --> 01:54:32,095 I REALIZED IT'S ALMOST MYTHICAL 2573 01:54:32,095 --> 01:54:33,797 TO CONSIDER BIOMARKERS AND 2574 01:54:33,797 --> 01:54:35,999 WONDERFUL TO SEE THE PROGRESS. 2575 01:54:35,999 --> 01:54:37,467 I'M INTERESTED IN THE 2576 01:54:37,467 --> 01:54:39,403 CONNECTIVITY TO MODIFIABLE 2577 01:54:39,403 --> 01:54:40,304 OUTCOMES. 2578 01:54:40,304 --> 01:54:43,574 THAT'S WHERE WE WANT TO GO. 2579 01:54:43,574 --> 01:54:44,608 THAT'S SOMETHING I DIDN'T HEAR A 2580 01:54:44,608 --> 01:54:47,377 LOT ABOUT BUT I KNOW YOU ALL 2581 01:54:47,377 --> 01:54:49,646 HAVE TERRIFIC IDEAS ON THAT. 2582 01:54:49,646 --> 01:54:53,650 HOW WE CAN USE THESE MORE 2583 01:54:53,650 --> 01:54:55,085 DIRECTLY TO CONNECT TO 2584 01:54:55,085 --> 01:55:01,124 MODIFIABLE OUTCOMES. 2585 01:55:01,124 --> 01:55:05,095 >> YEAH, I CAN LET OTHER 2586 01:55:05,095 --> 01:55:07,464 PANELISTS CHIME IN. 2587 01:55:07,464 --> 01:55:12,302 ROB PROBABLY HAS THOUGHTS ON 2588 01:55:12,302 --> 01:55:13,837 THIS TOO. 2589 01:55:13,837 --> 01:55:20,544 I THINK THE FLUID BIOMARKERS ARE 2590 01:55:20,544 --> 01:55:23,113 IMPERFECT WHEN IT COMES TO 2591 01:55:23,113 --> 01:55:30,721 TRACKING THE EFFICACY OF THE 2592 01:55:30,721 --> 01:55:34,291 APPROVED DRUGS. 2593 01:55:34,291 --> 01:55:37,060 EVEN THOUGH THOSE PLASMA 2594 01:55:37,060 --> 01:55:39,229 BIOMARKERS ARE VERY GOOD 2595 01:55:39,229 --> 01:55:40,530 DISTINGUISHING WHO HAS AND 2596 01:55:40,530 --> 01:55:42,532 DOESN'T HAVE AMYLOID AND ONCE 2597 01:55:42,532 --> 01:55:44,134 THEY'RE ON THE DRUG THEY DON'T 2598 01:55:44,134 --> 01:55:45,168 HELP US TRACK THE CLEARANCE AS 2599 01:55:45,168 --> 01:55:47,104 WELL AS WE WOULD LIKE. 2600 01:55:47,104 --> 01:55:49,806 AND SO WE'RE STILL STUCK WITH I 2601 01:55:49,806 --> 01:55:50,374 THINK PET LIKE ENDS AT THIS 2602 01:55:50,374 --> 01:55:53,110 POINT. 2603 01:55:53,110 --> 01:55:55,512 I THINK AS WE DEVELOP NEW 2604 01:55:55,512 --> 01:55:57,914 THERAPEUTICS IT'S GOING TO BE 2605 01:55:57,914 --> 01:56:00,250 CRITICALLY IMPORTANT THAT WE 2606 01:56:00,250 --> 01:56:04,021 DEVELOP IN PARALLEL TARGET 2607 01:56:04,021 --> 01:56:06,156 ENGAGEMENT BIOMARKERS SO THAT WE 2608 01:56:06,156 --> 01:56:07,190 CAN HAVE THE READ OUT THAT 2609 01:56:07,190 --> 01:56:08,659 YOU'RE TALKING ABOUT. 2610 01:56:08,659 --> 01:56:12,462 AND SO I WOULD ENCOURAGE ANYONE 2611 01:56:12,462 --> 01:56:13,597 WITH A DRUG DEVELOPMENT PROGRAM 2612 01:56:13,597 --> 01:56:15,832 TO ALSO BE THINKING ABOUT A 2613 01:56:15,832 --> 01:56:21,038 CLEAR TARGET ENGAGEMENT 2614 01:56:21,038 --> 01:56:22,239 MODIFIABLE OUTCOME BIOMARKER 2615 01:56:22,239 --> 01:56:26,710 THAT THEY WILL DEVELOP IN 2616 01:56:26,710 --> 01:56:31,081 PARALLEL WITH THE DRUG. 2617 01:56:31,081 --> 01:56:33,684 >> I AGREE WITH WHAT YOU'RE 2618 01:56:33,684 --> 01:56:34,785 SAYING DONNA DEFINITELY. 2619 01:56:34,785 --> 01:56:37,454 I THINK WE'RE GETTING THERE IN 2620 01:56:37,454 --> 01:56:40,157 TERMS OF USING PLASMA BIOMARKERS 2621 01:56:40,157 --> 01:56:43,794 OR CSF BIOMARKER PHARMACO 2622 01:56:43,794 --> 01:56:45,629 DYNAMICALLY WATCHING THEM CHANGE 2623 01:56:45,629 --> 01:56:46,730 AS AMYLOID CHANGE. 2624 01:56:46,730 --> 01:56:47,331 WE'RE STILL EARLY DAYS. 2625 01:56:47,331 --> 01:56:49,366 IT'S IN DEVELOPMENT. 2626 01:56:49,366 --> 01:56:52,602 I AGREE PERHAPS AT THE MOMENT 2627 01:56:52,602 --> 01:56:54,705 PET IS STILL NEEDED. 2628 01:56:54,705 --> 01:56:56,106 FOR EXAMPLE IN THE A4 TRIAL 2629 01:56:56,106 --> 01:56:58,175 WHICH WAS NEGATIVE, WE DID SEE 2630 01:56:58,175 --> 01:57:01,678 SOME CHANGE IN AMYLOID 2631 01:57:01,678 --> 01:57:02,579 ACCUMULATION THAT WAS ONLY 2632 01:57:02,579 --> 01:57:03,580 VISIBLE BY PET. 2633 01:57:03,580 --> 01:57:06,249 WHEN YOU LOOK AT P TAU, 217 IT 2634 01:57:06,249 --> 01:57:07,684 WAS NOT SIGNIFICANT. 2635 01:57:07,684 --> 01:57:14,725 I THINK AS THE ASSAYS GET 2636 01:57:14,725 --> 01:57:17,127 REFINED AND BETTER BUT WE'RE NOT 2637 01:57:17,127 --> 01:57:26,169 QUITE THERE YET. 2638 01:57:26,169 --> 01:57:28,872 >> ERIN. 2639 01:57:28,872 --> 01:57:31,141 >> FOR THE AD BIOSIGNATURE IT'S 2640 01:57:31,141 --> 01:57:32,943 BEEN DISCUSSED AT A HIGH LEVEL 2641 01:57:32,943 --> 01:57:34,044 WE COULD AS DATA SETS BECOME 2642 01:57:34,044 --> 01:57:36,380 AVAILABLE SO ACCESS MAY BE A 2643 01:57:36,380 --> 01:57:37,714 CHALLENGE BUT IF WE GET 2644 01:57:37,714 --> 01:57:38,615 INTERVENTION TRIAL DATA WE CAN 2645 01:57:38,615 --> 01:57:41,118 LOOK AT OTHER CONTEXT OF USE 2646 01:57:41,118 --> 01:57:43,387 INCLUDING THOSE WITH THE 2647 01:57:43,387 --> 01:57:44,020 MODIFIABLE OUTCOMES. 2648 01:57:44,020 --> 01:57:45,155 I APPRECIATE YOUR QUESTION. 2649 01:57:45,155 --> 01:57:45,422 THANK YOU. 2650 01:57:45,422 --> 01:57:48,892 >> I THINK IN THE INTEREST OF 2651 01:57:48,892 --> 01:57:50,494 TIME WE HAVE 12 MINUTES TO GET 2652 01:57:50,494 --> 01:57:52,696 TO THESE QUESTIONS. 2653 01:57:52,696 --> 01:57:54,631 I'M GOING TO ALTERNATE THE 2654 01:57:54,631 --> 01:57:58,835 MICROPHONE TO MY LEFT, PLEASE. 2655 01:57:58,835 --> 01:58:01,271 >> IAN KRIEGER. 2656 01:58:01,271 --> 01:58:02,706 REMARKABLE SESSION AND I'LL 2657 01:58:02,706 --> 01:58:06,276 OFFER A COMMENT BUT A PREAMBLE 2658 01:58:06,276 --> 01:58:09,479 IS I'M WILDLY ENTHUSIASTIC ABOUT 2659 01:58:09,479 --> 01:58:12,115 EVERYTHING YOU'RE DOING BUT -- I 2660 01:58:12,115 --> 01:58:16,553 HOPE THAT ALL OF YOU THAT WORK 2661 01:58:16,553 --> 01:58:18,488 IN THE BIOMARKER SPACE AND NIA 2662 01:58:18,488 --> 01:58:22,592 AND ITS ROLE IN LEADERSHIP WITH 2663 01:58:22,592 --> 01:58:26,329 PARTNERS LIKE FDA AND CMS WHILE 2664 01:58:26,329 --> 01:58:28,732 DIVE DEEPLY INTO THE ETHICS AND 2665 01:58:28,732 --> 01:58:31,067 APPLYING THIS IN REAL WORLD 2666 01:58:31,067 --> 01:58:32,602 SETTINGS. 2667 01:58:32,602 --> 01:58:34,004 THERE'S ENORMOUS POWER IN WHAT 2668 01:58:34,004 --> 01:58:35,939 YOU ARE OFFERING TO NOT ONLY 2669 01:58:35,939 --> 01:58:38,275 CLINICIANS BUT TO THEIR CURRENT 2670 01:58:38,275 --> 01:58:41,178 AND FUTURE PATIENTS, WHOLE HUMAN 2671 01:58:41,178 --> 01:58:42,379 BEINGS. 2672 01:58:42,379 --> 01:58:43,914 IN THE SAME WAY THIS CONFERENCE, 2673 01:58:43,914 --> 01:58:45,916 THIS SUMMIT IS FOCUSSED ON 2674 01:58:45,916 --> 01:58:47,551 PRECISION MEDICINE, WE NEED TO 2675 01:58:47,551 --> 01:58:49,753 WORK HARD REALLY HARD TO MAKE 2676 01:58:49,753 --> 01:58:55,692 SURE WE HAVE PRECISION IN THE 2677 01:58:55,692 --> 01:59:01,698 WAY INFORMATION IS DISCLOSED AND 2678 01:59:01,698 --> 01:59:04,334 THEN ACTION OF THE DISCLOSURE 2679 01:59:04,334 --> 01:59:06,703 DIRECTED THE RECIPIENTS OF THE 2680 01:59:06,703 --> 01:59:08,338 BIOMARKER IS AT LEAST AS 2681 01:59:08,338 --> 01:59:09,940 SIGNIFICANT IN TERMS DISEASE 2682 01:59:09,940 --> 01:59:11,741 PROCESSES AND THE RELEVANT 2683 01:59:11,741 --> 01:59:13,977 APPLICATIONS OF HOW TO TACKLE 2684 01:59:13,977 --> 01:59:17,214 THOSE DISEASES AND THE 2685 01:59:17,214 --> 01:59:18,715 MANIFESTATIONS OF SYMPTOMS. 2686 01:59:18,715 --> 01:59:24,621 THERE IS ENORMOUS DANGER THAT 2687 01:59:24,621 --> 01:59:26,523 WE'RE ALREADY LIVING WITH IN 2688 01:59:26,523 --> 01:59:30,594 UNLEASHING THIS KIND OF DATA 2689 01:59:30,594 --> 01:59:33,029 DIRECT TO CONSUMER NEVER MIND 2690 01:59:33,029 --> 01:59:34,331 WHEN IT'S FILTERED THROUGH 2691 01:59:34,331 --> 01:59:35,999 CLINICIANS THE PATIENT MAY OR 2692 01:59:35,999 --> 01:59:38,702 MAY NOT HAVE A DEEP MEANINGFUL 2693 01:59:38,702 --> 01:59:39,069 RELATIONSHIP. 2694 01:59:39,069 --> 01:59:41,872 AND FEW OF US ACTUALLY HAVE A 2695 01:59:41,872 --> 01:59:44,641 DEEP PERSONAL RELATIONSHIP. 2696 01:59:44,641 --> 01:59:46,543 WE HAVE THIS MASSIVE TURNOVER ON 2697 01:59:46,543 --> 01:59:48,845 WHICH CLINICIAN WE SEE ON WHICH 2698 01:59:48,845 --> 01:59:50,113 VISIT ABOUT WHICH SPECIFIC 2699 01:59:50,113 --> 01:59:53,683 COMPLAINT OR RISK FACTOR. 2700 01:59:53,683 --> 01:59:55,719 SO IF WE ARE GOING TO GO DOWN 2701 01:59:55,719 --> 01:59:57,454 THIS COURSE, YOU CAN'T GET THE 2702 01:59:57,454 --> 02:00:02,726 HORSE BACK INSIDE THE BARN. 2703 02:00:02,726 --> 02:00:05,128 BUT WE CAN CHOOSE WHETHER WE 2704 02:00:05,128 --> 02:00:08,865 PERSONALIZE IN A CULTURALLY 2705 02:00:08,865 --> 02:00:11,401 SENSITIVE AND RESPONSIVE WAY 2706 02:00:11,401 --> 02:00:12,435 WHEN PEOPLE GET THIS 2707 02:00:12,435 --> 02:00:16,540 INFORMATION, ARE THEY EQUIPPED 2708 02:00:16,540 --> 02:00:18,508 TO INTERPRET IT OR ASSISTED IN 2709 02:00:18,508 --> 02:00:19,843 INTERPRETING IT AND KNOWING WHAT 2710 02:00:19,843 --> 02:00:22,112 TO DO WITH THE INFORMATION AND 2711 02:00:22,112 --> 02:00:24,281 WHAT GOD HELP US AND THEM, THEY 2712 02:00:24,281 --> 02:00:26,016 OUGHT NOT DO WITH THE 2713 02:00:26,016 --> 02:00:26,349 INFORMATION. 2714 02:00:26,349 --> 02:00:28,151 I'LL END ON THIS. 2715 02:00:28,151 --> 02:00:30,387 WE ALL KNOW DISCLOSURE OF A 2716 02:00:30,387 --> 02:00:33,189 DIAGNOSIS OF ALZHEIMER'S CAN BE 2717 02:00:33,189 --> 02:00:35,792 DONE WELL OR DONE BADLY AND WHEN 2718 02:00:35,792 --> 02:00:37,394 IT IS DONE BADLY THE LITERATURE 2719 02:00:37,394 --> 02:00:40,830 IS RICH ABOUT THE ELEVATION IN 2720 02:00:40,830 --> 02:00:41,131 SUICIDALITY. 2721 02:00:41,131 --> 02:00:43,934 SO LET'S DO THIS WELL. 2722 02:00:43,934 --> 02:00:46,069 LET'S PLAN BEFORE ALL OF THE 2723 02:00:46,069 --> 02:00:51,474 HORSES ARE OUT OF ALL THE BARNS 2724 02:00:51,474 --> 02:00:55,946 AND MAKE SURE THAT WE'RE BEING 2725 02:00:55,946 --> 02:00:56,813 PERSONALIZED IN A WAY DISCLOSURE 2726 02:00:56,813 --> 02:00:59,149 IS DONE AND PROACTIVE IN GIVING 2727 02:00:59,149 --> 02:01:02,018 PEOPLE TOOLS TO UTILIZE THE 2728 02:01:02,018 --> 02:01:05,021 INFORMATION THAT'S DISCLOSED IN 2729 02:01:05,021 --> 02:01:06,122 A SCIENTIFICALLY ACCURATE AND 2730 02:01:06,122 --> 02:01:06,790 MEANINGFUL WAY TO IMPROVE THEIR 2731 02:01:06,790 --> 02:01:10,527 QUALITY OF LIFE. 2732 02:01:10,527 --> 02:01:15,565 >> SO, I 110% AGREE WITH 2733 02:01:15,565 --> 02:01:18,001 EVERYTHING YOU JUST SAID. 2734 02:01:18,001 --> 02:01:22,806 I WAS RELIEVED TO SEE THE QUEST 2735 02:01:22,806 --> 02:01:25,108 DIRECT TO CONSUMER WAS PULLED 2736 02:01:25,108 --> 02:01:25,442 BACK. 2737 02:01:25,442 --> 02:01:27,177 THERE WAS A BACKLASH. 2738 02:01:27,177 --> 02:01:28,445 I KNOW SOMEONE ELSE IS PUTTING 2739 02:01:28,445 --> 02:01:32,349 OUT DIRECT TO CONSUMER WHICH IS 2740 02:01:32,349 --> 02:01:32,616 WORRYING. 2741 02:01:32,616 --> 02:01:35,552 I THINK THIS IS A MOVING FIELD 2742 02:01:35,552 --> 02:01:39,923 AND A MOVING TARGET AND SO RIGHT 2743 02:01:39,923 --> 02:01:41,725 NOW I DON'T KNOW THAT THERE'S A 2744 02:01:41,725 --> 02:01:44,394 NEED TO DO PLASMA BIOMARKERS 2745 02:01:44,394 --> 02:01:47,697 CLINICALLY UNLESS SOMEONE HAS A 2746 02:01:47,697 --> 02:01:48,598 COGNITIVE COMPLAINT BECAUSE THEN 2747 02:01:48,598 --> 02:01:50,400 THEY CAN POTENTIALLY BE 2748 02:01:50,400 --> 02:01:56,473 CANDIDATES FOR THE NEW DRUGS. 2749 02:01:56,473 --> 02:01:58,775 I THINK AS THE HEAD TRIAL READS 2750 02:01:58,775 --> 02:02:02,712 OUT IN A COUPLE YEARS WHERE 2751 02:02:02,712 --> 02:02:05,215 WE'RE LOOKING AT WHETHER 2752 02:02:05,215 --> 02:02:06,616 TREATMENT'S EFFECTIVE THAT WILL 2753 02:02:06,616 --> 02:02:08,418 CHANGE THE LANDSCAPE OF HOW WE 2754 02:02:08,418 --> 02:02:11,955 DO BIOMARKERS CLINICALLY IF 2755 02:02:11,955 --> 02:02:14,057 PRE-CLINICAL A.D. TREATMENT IS 2756 02:02:14,057 --> 02:02:15,892 NOW APPROVED. 2757 02:02:15,892 --> 02:02:20,263 SO I THINK WE HAVE -- I THINK WE 2758 02:02:20,263 --> 02:02:24,668 ALL APPRECIATE YOUR POINT ABOUT 2759 02:02:24,668 --> 02:02:25,935 HOW ETHICALLY AND RESPONSIBLY WE 2760 02:02:25,935 --> 02:02:27,470 HAVE TO MANAGE THE DATA AND WHAT 2761 02:02:27,470 --> 02:02:29,706 WE SHARE WITH THE PATIENTS BUT I 2762 02:02:29,706 --> 02:02:31,675 WILL SAY A LOT OF OUR RESEARCH 2763 02:02:31,675 --> 02:02:32,242 PARTICIPANTS WANT THIS 2764 02:02:32,242 --> 02:02:32,676 INFORMATION BACK. 2765 02:02:32,676 --> 02:02:34,210 I THINK IT'S JUST A CASE OF HOW 2766 02:02:34,210 --> 02:02:37,747 WE GIVE IT BACK TO THEM AND THE 2767 02:02:37,747 --> 02:02:40,016 KIND OF COUNSELLING THEY ARE GET 2768 02:02:40,016 --> 02:02:46,022 AHEAD OF HEARING THOSE RESULTS. 2769 02:02:46,022 --> 02:02:48,324 >> I TOO AGREE. 2770 02:02:48,324 --> 02:02:50,160 HAVING SAID THAT THERE ARE 2771 02:02:50,160 --> 02:02:52,996 FRAMEWORKS ALREADY IN PLACE. 2772 02:02:52,996 --> 02:02:56,900 WE SEE PATIENTS IN THE PRIMARY 2773 02:02:56,900 --> 02:02:58,501 CARE SETTING. 2774 02:02:58,501 --> 02:03:00,136 WE TELL THEM THEY HAVE PROSTATE 2775 02:03:00,136 --> 02:03:00,570 CANCER. 2776 02:03:00,570 --> 02:03:02,605 WE MEASURE THEIR LIPIDS AND LOOK 2777 02:03:02,605 --> 02:03:04,274 AT THEIR EKG AND TELL THEM 2778 02:03:04,274 --> 02:03:07,777 YOU'RE AT RISK OF STROKE, A 2779 02:03:07,777 --> 02:03:08,445 HEART ATTACK. 2780 02:03:08,445 --> 02:03:09,345 WE DELIVER THESE THINGS AND DONE 2781 02:03:09,345 --> 02:03:11,381 IN A FRAMEWORK. 2782 02:03:11,381 --> 02:03:13,083 WE CAN BORROW FROM THE SAME 2783 02:03:13,083 --> 02:03:18,121 FRAME WORK BUT WE NEED TO ALSO 2784 02:03:18,121 --> 02:03:19,389 BE COGNIZANT OF THE FACT THE 2785 02:03:19,389 --> 02:03:21,324 BIOMARKERS CANNOT BE JUST THE 2786 02:03:21,324 --> 02:03:22,692 PROPERTY OF THE SUB, SUB, SUB 2787 02:03:22,692 --> 02:03:26,696 SPECIALIST. 2788 02:03:26,696 --> 02:03:33,036 IT UP TO PRIMARY CARE 2789 02:03:33,036 --> 02:03:33,970 PHYSICIANS BECAUSE WE'RE DEALING 2790 02:03:33,970 --> 02:03:36,473 WITH AN EPIDEMIC AND DEALING 2791 02:03:36,473 --> 02:03:37,140 WITH POTENTIALLY DANGEROUS 2792 02:03:37,140 --> 02:03:38,208 INFORMATION WHICH IT COULD BE WE 2793 02:03:38,208 --> 02:03:43,279 CAN BORROW FROM THE EXISTING 2794 02:03:43,279 --> 02:03:44,280 FRAMEWORKS. 2795 02:03:44,280 --> 02:03:45,615 WE NEED TO BE COGNIZANT OF THE 2796 02:03:45,615 --> 02:03:48,752 FACT THAT IT CANNOT JUST BE THE 2797 02:03:48,752 --> 02:03:51,387 SUB SPECIALIST AND TERTIARY CARE 2798 02:03:51,387 --> 02:03:51,755 CENTERS. 2799 02:03:51,755 --> 02:03:54,057 WE NEED TO TRAIN PHYSICIANS 2800 02:03:54,057 --> 02:03:56,226 APPROPRIATELY AND TRAIN MORE 2801 02:03:56,226 --> 02:03:58,461 NEUROLOGISTS, MORE BEHAVIORAL 2802 02:03:58,461 --> 02:04:00,563 NEUROLOGISTS, MORE NEURAL 2803 02:04:00,563 --> 02:04:02,565 PATHOLOGISTS WHO ARE WELL VERSED 2804 02:04:02,565 --> 02:04:05,168 IN THE SCIENCE AND NEED TO TRAIN 2805 02:04:05,168 --> 02:04:06,369 MORE SCIENTISTS WELL VERSED IN 2806 02:04:06,369 --> 02:04:08,772 THE REAL LIFE APPLICATIONS. 2807 02:04:08,772 --> 02:04:12,242 >> I JUST WANT TO ADD QUICKLY IN 2808 02:04:12,242 --> 02:04:13,843 THE REALM OF DIGITAL IT'S 2809 02:04:13,843 --> 02:04:15,411 ALREADY OUT THERE. 2810 02:04:15,411 --> 02:04:20,283 I TOLD YOU IT'S $35 BILLION AND 2811 02:04:20,283 --> 02:04:20,950 GLOBAL. 2812 02:04:20,950 --> 02:04:22,051 THERE AREN'T RESOURCES AVAILABLE 2813 02:04:22,051 --> 02:04:23,453 AND I THINK WE ALSO NEED TO 2814 02:04:23,453 --> 02:04:25,722 THINK ABOUT HOW WE TURN THIS 2815 02:04:25,722 --> 02:04:26,956 AROUND INTO SORT OF THINKING 2816 02:04:26,956 --> 02:04:29,993 ABOUT THE CITIZEN SCIENTISTS. 2817 02:04:29,993 --> 02:04:31,861 GENETICS ALREADY DID THAT WITH 2818 02:04:31,861 --> 02:04:32,328 THE COMMERCIALIZATION. 2819 02:04:32,328 --> 02:04:37,400 WE NEED TO DO A BETTER JOB OF 2820 02:04:37,400 --> 02:04:38,635 PUSHING THIS OUT THERE IN THE 2821 02:04:38,635 --> 02:04:39,869 GREATER CONTEXT IN MY CASE I 2822 02:04:39,869 --> 02:04:42,305 LIKE TO THINK ABOUT PRECISION 2823 02:04:42,305 --> 02:04:44,407 BRAIN HEALTH SO YOU'RE THINKING 2824 02:04:44,407 --> 02:04:45,475 ABOUT YOUR HEALTH ACROSS YOUR 2825 02:04:45,475 --> 02:04:47,010 ENTIRE LIFE SPAN. 2826 02:04:47,010 --> 02:04:50,046 WE THINK OF THIS AS LIFE COURSE 2827 02:04:50,046 --> 02:04:50,280 ANYWAYS. 2828 02:04:50,280 --> 02:04:52,248 SO YOU'RE LEARNING HOW TO USE 2829 02:04:52,248 --> 02:04:54,517 THESE DIFFERENT DEVICES YOU 2830 02:04:54,517 --> 02:04:56,586 ALREADY ARE FEEDING BACK 2831 02:04:56,586 --> 02:04:57,220 INFORMATION AND EDUCATING. 2832 02:04:57,220 --> 02:04:59,889 SO THIS IS SORT OF A PUBLIC 2833 02:04:59,889 --> 02:05:00,924 AWARENESS, PUBLIC EDUCATION 2834 02:05:00,924 --> 02:05:03,026 MOVEMENT THAT NEEDS TO GO. 2835 02:05:03,026 --> 02:05:06,696 I DO THINK WE HAVE SOME OF THESE 2836 02:05:06,696 --> 02:05:08,565 DIRECT TO CONSUMER PRODUCTS TO 2837 02:05:08,565 --> 02:05:09,566 LEARN LESSONS FROM THAT. 2838 02:05:09,566 --> 02:05:11,734 I WANT TO MAKE SURE WE 2839 02:05:11,734 --> 02:05:13,803 DIFFERENTIATE BETWEEN WHAT CAN 2840 02:05:13,803 --> 02:05:15,705 BE DRIVEN THROUGH OUR HEALTH 2841 02:05:15,705 --> 02:05:17,173 CARE VERSUS WHAT'S HAPPENING 2842 02:05:17,173 --> 02:05:18,675 ALREADY. 2843 02:05:18,675 --> 02:05:19,876 >> THANK YOU. 2844 02:05:19,876 --> 02:05:21,444 IN THE INTEREST OF TIME WE ARE 2845 02:05:21,444 --> 02:05:22,812 GOING TO DO QUICK QUESTIONS, 2846 02:05:22,812 --> 02:05:25,215 QUICK ANSWERS. 2847 02:05:25,215 --> 02:05:25,949 SO GO AHEAD. 2848 02:05:25,949 --> 02:05:31,287 >> DR. RISSMAN AS WE EMBARKED IN 2849 02:05:31,287 --> 02:05:32,388 THE PAST DECADE IMPROVING 2850 02:05:32,388 --> 02:05:33,656 SAMPLES AND BLOOD BIOMARKERS. 2851 02:05:33,656 --> 02:05:35,825 YOU HEARD ABOUT METABOLOMICS AND 2852 02:05:35,825 --> 02:05:38,628 THE FANTASTIC POWER THAT IT CAN 2853 02:05:38,628 --> 02:05:42,165 INFORM AND WE ARE ADDING OUR 2854 02:05:42,165 --> 02:05:43,066 PARTNERS WITH THE PROTEOME. 2855 02:05:43,066 --> 02:05:45,101 I HOPE WE CAN TAKE THE LESSONS 2856 02:05:45,101 --> 02:05:47,537 FROM THE ADNI AND LINKAGES TO 2857 02:05:47,537 --> 02:05:50,006 THE MARKERS AND BE ABLE TO APPLY 2858 02:05:50,006 --> 02:05:52,742 TO THE FANTASTIC DIVERSE COHORT 2859 02:05:52,742 --> 02:05:54,444 YOU ARE WORKING ON WITH THE 2860 02:05:54,444 --> 02:05:55,211 FANTASTIC TEAM. 2861 02:05:55,211 --> 02:05:57,180 HOW CAN WE BRIDGE THIS KNOWLEDGE 2862 02:05:57,180 --> 02:05:59,883 SO WE CAN QUICKLY MOVE AND 2863 02:05:59,883 --> 02:06:02,218 DEFINE WHAT IS DIFFERENT IN 2864 02:06:02,218 --> 02:06:02,719 DIVERSE POPULATIONS. 2865 02:06:02,719 --> 02:06:04,687 >> THANKS, REMA. 2866 02:06:04,687 --> 02:06:06,456 >> IT'S A GOOD QUESTION. 2867 02:06:06,456 --> 02:06:14,163 THE KEY HERE IS THROUGH DATA 2868 02:06:14,163 --> 02:06:17,033 SHARING AND ALL THE AND THERE'S 2869 02:06:17,033 --> 02:06:19,369 FREE SHARING SOON IT'S 2870 02:06:19,369 --> 02:06:19,769 GENERATED. 2871 02:06:19,769 --> 02:06:21,371 SO ALL THE THINGS CAN BE 2872 02:06:21,371 --> 02:06:25,642 COMPARED TO DATA SETS SUCH AS 2873 02:06:25,642 --> 02:06:26,709 ADNI OR EVEN OTHER CLINICAL 2874 02:06:26,709 --> 02:06:29,078 TRIAL DATA SETS LIKE THE A4 JUST 2875 02:06:29,078 --> 02:06:29,646 RELEASED OR HEAD SCREENING 2876 02:06:29,646 --> 02:06:31,180 SAMPLE. 2877 02:06:31,180 --> 02:06:33,349 >> WORKING ON HARMONIZATION OF 2878 02:06:33,349 --> 02:06:35,952 THE METABOLOMICS AND SURE OUR 2879 02:06:35,952 --> 02:06:37,954 PARTNERS WITH PROTEOMICS IF 2880 02:06:37,954 --> 02:06:40,023 WE'RE ABLE TO DO THIS WE CAN 2881 02:06:40,023 --> 02:06:41,524 COMPARE AND CONNECT THE DATA 2882 02:06:41,524 --> 02:06:41,724 SETS. 2883 02:06:41,724 --> 02:06:42,992 >> I AGREE. 2884 02:06:42,992 --> 02:06:43,493 >> SOUNDS GREAT. 2885 02:06:43,493 --> 02:06:45,962 PLEASE GO AHEAD. 2886 02:06:45,962 --> 02:06:49,098 >> HI. 2887 02:06:49,098 --> 02:06:50,533 IT'S A QUESTION FOR LEE. 2888 02:06:50,533 --> 02:06:56,272 I LIKE THE APPROACH OF USING 2889 02:06:56,272 --> 02:06:57,340 OCULAR IMAGING TO DIAGNOSE. 2890 02:06:57,340 --> 02:06:59,842 I THINK IT'S FANTASTIC. 2891 02:06:59,842 --> 02:07:02,178 MORE PEOPLE GO REGULARLY THROUGH 2892 02:07:02,178 --> 02:07:05,181 THEIR LIFE TIME TO HAVE THESE 2893 02:07:05,181 --> 02:07:06,716 TESTS. 2894 02:07:06,716 --> 02:07:09,619 I WANTED TO KNOW GIVEN THAT AN 2895 02:07:09,619 --> 02:07:14,357 AMYLOID IS ASSOCIATED WITH AMD 2896 02:07:14,357 --> 02:07:19,896 THAT RPE CELLS EXPRESS ALPHA B 2897 02:07:19,896 --> 02:07:21,998 CYST TALIN. 2898 02:07:21,998 --> 02:07:24,834 IS THERE AN ASSOCIATION WITH AND 2899 02:07:24,834 --> 02:07:27,270 IN THE PATIENTS AND NUMBER 2, 2900 02:07:27,270 --> 02:07:32,308 GIVEN THERE'S CLEAR GENETIC 2901 02:07:32,308 --> 02:07:35,511 ANCESTRY ASSOCIATION WITH AMD 2902 02:07:35,511 --> 02:07:36,980 INCIDENTS, ARE YOU SEEING THAT 2903 02:07:36,980 --> 02:07:40,950 IN YOUR STUDIES? 2904 02:07:40,950 --> 02:07:41,451 HAVE YOU DONE A DIVERSE 2905 02:07:41,451 --> 02:07:47,190 POPULATION STUDY? 2906 02:07:47,190 --> 02:07:47,657 >> YES. 2907 02:07:47,657 --> 02:07:50,093 THE SITUATION IN THE RETINA IS A 2908 02:07:50,093 --> 02:07:54,364 BIT MORE COMPLEX. 2909 02:07:54,364 --> 02:07:57,266 ACTUALLY DR. RISSMAN AND OTHERS 2910 02:07:57,266 --> 02:08:00,503 HAVE DONE WORK IN THAT AS WELL. 2911 02:08:00,503 --> 02:08:03,039 IT'S A LITTLE BIT MORE COMPLEX. 2912 02:08:03,039 --> 02:08:05,908 AND IT'S NOT AT ALL AS CLEAR AS 2913 02:08:05,908 --> 02:08:09,178 IT IS IN THE LENS, NO PUN 2914 02:08:09,178 --> 02:08:11,647 INTENDED THERE WHERE IT'S VERY 2915 02:08:11,647 --> 02:08:12,015 STRAIGHTFORWARD. 2916 02:08:12,015 --> 02:08:15,752 THERE'S AD ASSOCIATED AMYLOID 2917 02:08:15,752 --> 02:08:18,721 DEVELOPMENT IN THE LENS WE 2918 02:08:18,721 --> 02:08:20,289 WORKED OUT IN MOLECULAR 2919 02:08:20,289 --> 02:08:23,226 PHENOTYPE AND WE'VE SEEN IT IN 2920 02:08:23,226 --> 02:08:25,161 DOWN SYNDROME AND TRANSGENIC 2921 02:08:25,161 --> 02:08:29,932 MICE AND IT'S AN A DIRECT AND 2922 02:08:29,932 --> 02:08:30,366 EARLY MARKER. 2923 02:08:30,366 --> 02:08:33,002 IT'S NOT INFLUENCED BY OTHER 2924 02:08:33,002 --> 02:08:34,370 COMPLICATIONS IN THE RETINA, FOR 2925 02:08:34,370 --> 02:08:35,204 EXAMPLE. 2926 02:08:35,204 --> 02:08:36,305 I THINK THERE'S STILL WORK TO BE 2927 02:08:36,305 --> 02:08:40,376 DONE AND OTHER COMPARTMENTS 2928 02:08:40,376 --> 02:08:41,577 INCLUDE THE AQUEOUS AND 2929 02:08:41,577 --> 02:08:43,212 COLLEAGUES HAVE SHOWN A BETA IN 2930 02:08:43,212 --> 02:08:43,713 BOTH. 2931 02:08:43,713 --> 02:08:46,716 I THINK IT'S AN OPTICALLY 2932 02:08:46,716 --> 02:08:48,084 ACCESSIBLE COMPARTMENT TO LOOK 2933 02:08:48,084 --> 02:08:50,486 AT THE KINETICS AND DYNAMICS OF 2934 02:08:50,486 --> 02:08:51,888 THE FRONT OF OF THE EYE THAT MAY 2935 02:08:51,888 --> 02:08:54,424 GIVE US SOME TOOLS NOT ONLY FOR 2936 02:08:54,424 --> 02:08:55,625 DOING DISCRIMINATION FOR STUDIES 2937 02:08:55,625 --> 02:08:58,528 BUT ALSO LOOKING AT DYNAMICS 2938 02:08:58,528 --> 02:09:06,235 WHERE WE DON'T HAVE TO DO LPs 2939 02:09:06,235 --> 02:09:07,236 AND SUCH. 2940 02:09:07,236 --> 02:09:10,406 I THINK THERE'S WORK TO DO. 2941 02:09:10,406 --> 02:09:14,343 ROBERT I THINK YOU AGREE WITH 2942 02:09:14,343 --> 02:09:14,844 THAT. 2943 02:09:14,844 --> 02:09:17,213 >> OKAY MAYBE YOU CAN DISCUSS 2944 02:09:17,213 --> 02:09:17,914 OFFLINE DURING THE BREAK. 2945 02:09:17,914 --> 02:09:20,650 THESE ARE GOING TO BE THE LAST 2946 02:09:20,650 --> 02:09:22,618 TWO QUESTIONS SO WE'LL GET TO 2947 02:09:22,618 --> 02:09:24,821 BOTH OF YOU, I HOPE IF THEY'RE 2948 02:09:24,821 --> 02:09:25,621 QUICK QUESTIONS AND ANSWERS. 2949 02:09:25,621 --> 02:09:27,390 ON MY RIGHT, PLEASE. 2950 02:09:27,390 --> 02:09:29,959 >> THANKS, DONNA. 2951 02:09:29,959 --> 02:09:32,028 I WAS ENCOURAGED BY YOUR 2952 02:09:32,028 --> 02:09:34,697 STATEMENT ABOUT THE AVAILABILITY 2953 02:09:34,697 --> 02:09:37,233 OF DATA KNOW THAT PEOPLE CAN GO 2954 02:09:37,233 --> 02:09:39,068 AND LOOK FOR REPRODUCIBILITY AND 2955 02:09:39,068 --> 02:09:40,136 FIND THEIR SIGNAL AND SEE 2956 02:09:40,136 --> 02:09:42,705 WHETHER IT VALIDATES. 2957 02:09:42,705 --> 02:09:45,274 WITH MY PHILANTHROPY FUNDER HAT 2958 02:09:45,274 --> 02:09:47,176 ON IT'S AN IMPORTANT PART OF 2959 02:09:47,176 --> 02:09:47,844 CONFIRMING THE CONFIDENCE IN THE 2960 02:09:47,844 --> 02:09:50,079 SCIENCE AND RESEARCH THAT WE DO. 2961 02:09:50,079 --> 02:09:53,883 ON THE OTHER HAND IF I PUT MY 2962 02:09:53,883 --> 02:09:57,253 RESEARCHER HAT ON, IT'S SO HARD 2963 02:09:57,253 --> 02:09:59,122 TO FIND THE TIME TO ANALYZE YOUR 2964 02:09:59,122 --> 02:10:02,725 OWN DATA, GOSH, WHERE DO YOU 2965 02:10:02,725 --> 02:10:06,262 FIND THAT TIME TO VALIDATE AND 2966 02:10:06,262 --> 02:10:06,929 TAKE ADVANTAGE OF THE WEALTH OF 2967 02:10:06,929 --> 02:10:08,564 DATA OUT THERE AND IF YOU THINK 2968 02:10:08,564 --> 02:10:11,033 OF WHAT JOURNALS AND FUNDERS DID 2969 02:10:11,033 --> 02:10:14,737 AND SUZANNA LOOKING AT YOU AS 2970 02:10:14,737 --> 02:10:16,772 WELL FROM A POLICY POINT OF VIEW 2971 02:10:16,772 --> 02:10:18,341 OR CULTURE POINT OF VIEW THERE 2972 02:10:18,341 --> 02:10:22,445 WAS A TIME WHEN SHARING WASN'T 2973 02:10:22,445 --> 02:10:24,814 MANDATED BUT THEN IT BECAME THE 2974 02:10:24,814 --> 02:10:25,248 NORM. 2975 02:10:25,248 --> 02:10:26,349 PEOPLE HAD TO DO IT AND FIGURE 2976 02:10:26,349 --> 02:10:29,152 OUT A WAY TO DO IT TO GET THEIR 2977 02:10:29,152 --> 02:10:31,354 GRANT AND THEIR PAPER AND THEN 2978 02:10:31,354 --> 02:10:34,690 SIMILARLY TO DATA BEHIND THE 2979 02:10:34,690 --> 02:10:36,092 FIGURE AND YOU WERE SAYING THE 2980 02:10:36,092 --> 02:10:39,262 NICE PAPER YOU JUST HAD COMING 2981 02:10:39,262 --> 02:10:45,201 OUT WITH THE TAU PET AND GWAS 2982 02:10:45,201 --> 02:10:47,336 REQUIRES THE UNDERLYING DATA AND 2983 02:10:47,336 --> 02:10:48,504 NOBODY WAS DOING THAT IN 2984 02:10:48,504 --> 02:10:49,639 GRADUATE SCHOOL AND TRAINING. 2985 02:10:49,639 --> 02:10:51,841 I'M WONDERING IS THERE A NEED 2986 02:10:51,841 --> 02:10:53,142 FOR A PUSH HERE WHETHER IT'S 2987 02:10:53,142 --> 02:10:57,313 FROM THE JOURNALS AND/OR THE 2988 02:10:57,313 --> 02:10:58,281 FUNDERS TO SAY YOU NEED TO 2989 02:10:58,281 --> 02:10:59,649 ACTUALLY GO AND LOOK AT THE DATA 2990 02:10:59,649 --> 02:11:02,418 THAT'S OUT THERE AND VALIDATE 2991 02:11:02,418 --> 02:11:04,954 WHAT YOU FOUND IN AT LEAST TWO 2992 02:11:04,954 --> 02:11:06,722 DIFFERENT DATA SETS BECAUSE 2993 02:11:06,722 --> 02:11:09,325 GOSH, AS A WES LAB BIO CHEMIST 2994 02:11:09,325 --> 02:11:12,128 WITHOUT A PUSH I PROBABLY WON'T 2995 02:11:12,128 --> 02:11:13,262 DO THAT COMPUTATIONAL WORK 2996 02:11:13,262 --> 02:11:15,598 BECAUSE IT'S NOT WHAT I'M GOOD 2997 02:11:15,598 --> 02:11:15,765 AT. 2998 02:11:15,765 --> 02:11:17,200 >> I THINK IT'S JOURNAL TO 2999 02:11:17,200 --> 02:11:21,704 JOURNAL BUT AS EDITOR-IN-CHIEF 3000 02:11:21,704 --> 02:11:26,709 ON ALZHEIMER'S AND DEMENTIA WHEN 3001 02:11:26,709 --> 02:11:30,713 WE GET BIOMEDICAL SUBMISSIONS WE 3002 02:11:30,713 --> 02:11:33,983 REQUIRE A VALIDATION COHORT IN 3003 02:11:33,983 --> 02:11:35,318 ANY OF THE FLUID BIOMARKER WORK. 3004 02:11:35,318 --> 02:11:38,020 SO I KNOW IT'S GOING TO VARY 3005 02:11:38,020 --> 02:11:39,822 JOURNAL TO JOURNAL BUT GENERALLY 3006 02:11:39,822 --> 02:11:42,725 WE LOOK FOR THAT AS A ROBUSTNESS 3007 02:11:42,725 --> 02:11:44,393 OF THE SCIENCE. 3008 02:11:44,393 --> 02:11:48,331 >> YEAH, I WOULD JUST SAY 3009 02:11:48,331 --> 02:11:49,832 THERE'S CHALLENGES ON THE 3010 02:11:49,832 --> 02:11:53,302 DIGITAL FRONT BECAUSE MANY OF 3011 02:11:53,302 --> 02:11:56,639 THE PLATFORM CAN'T ACCEPT THE 3012 02:11:56,639 --> 02:11:58,174 DIGITAL DATA STREAM TO CONNECT 3013 02:11:58,174 --> 02:11:59,008 WITH THE CLINICAL DATA. 3014 02:11:59,008 --> 02:12:01,611 ONE, WE HAVE TO SOLVE THAT AND 3015 02:12:01,611 --> 02:12:03,512 FIGURE OUT THE INTEROPERABILITY 3016 02:12:03,512 --> 02:12:04,981 BETWEEN PLATFORMS TO BRING IT 3017 02:12:04,981 --> 02:12:06,549 BECAUSE WE DON'T HAVE AS MUCH AS 3018 02:12:06,549 --> 02:12:11,120 DATA YET ON THE DIGITAL FRONT. 3019 02:12:11,120 --> 02:12:13,122 SO WE'RE SORT OF A LITTLE BIT 3020 02:12:13,122 --> 02:12:14,357 FURTHER BEHIND IN TERMS OF BEING 3021 02:12:14,357 --> 02:12:18,694 ABLE TO PUSH THIS FORWARD. 3022 02:12:18,694 --> 02:12:19,929 >> THANKS, RHODA. 3023 02:12:19,929 --> 02:12:21,897 I THINK WE CAN DISCUSS THIS ALL 3024 02:12:21,897 --> 02:12:25,301 DAY BUT I ACTUALLY THINK A.I. 3025 02:12:25,301 --> 02:12:29,372 MAY HAVE A PLACE IN HELPING US 3026 02:12:29,372 --> 02:12:34,710 DO THESE RAPID VALIDATION AND 3027 02:12:34,710 --> 02:12:37,546 EXISTING DATA SETS AND TAKE AWAY 3028 02:12:37,546 --> 02:12:38,581 SOME BURDEN ON THE INDIVIDUAL 3029 02:12:38,581 --> 02:12:39,215 SCIENTISTS BUT THAT MAY BE IN 3030 02:12:39,215 --> 02:12:42,518 THE FUTURE. 3031 02:12:42,518 --> 02:12:45,054 >> SO WE ACTUALLY HAVE TWO 3032 02:12:45,054 --> 02:12:46,255 QUESTIONS FROM ONLINE 3033 02:12:46,255 --> 02:12:48,391 PARTICIPANTS AND I'M HAPPY TO 3034 02:12:48,391 --> 02:12:50,293 LEAVE THEM AS FOOD FOR THOUGHT 3035 02:12:50,293 --> 02:12:53,029 IF THERE ISN'T TIME TO ADDRESS 3036 02:12:53,029 --> 02:12:53,229 BOTH. 3037 02:12:53,229 --> 02:12:56,232 ONE QUESTION IS HOW LONG CAN A 3038 02:12:56,232 --> 02:12:59,635 SAMPLE BE STORED AT MINUS 80 3039 02:12:59,635 --> 02:13:02,004 DEGREES CELSIUS FOR THE 3040 02:13:02,004 --> 02:13:02,705 ASSESSMENT AND THE OTHER 3041 02:13:02,705 --> 02:13:04,640 QUESTION IS SEVERAL OF THE 3042 02:13:04,640 --> 02:13:06,208 PRESENTATIONS FOCUSSED 3043 02:13:06,208 --> 02:13:08,611 SPECIFICALLY ON AD OR VASCULAR. 3044 02:13:08,611 --> 02:13:09,812 HOW DO WE LEVERAGE THIS EXCITING 3045 02:13:09,812 --> 02:13:11,747 WORK IN THINKING ABOUT THE 3046 02:13:11,747 --> 02:13:14,050 REALITY WHICH IS PRESENTED AT 3047 02:13:14,050 --> 02:13:17,386 THE BEGINNING FROM PATRICIA 3048 02:13:17,386 --> 02:13:19,655 BOYLE'S WORK SHOWING MOST OLDER 3049 02:13:19,655 --> 02:13:21,857 ADULTS AT AUTOPSY HAVE MULTIPLE 3050 02:13:21,857 --> 02:13:22,458 PATHOLOGIES AND IN DIFFERENT 3051 02:13:22,458 --> 02:13:25,361 COMBINATIONS? 3052 02:13:25,361 --> 02:13:28,264 >> I'LL SPEAK TO THE SECOND 3053 02:13:28,264 --> 02:13:29,832 QUESTION REAL QUICK BECAUSE I 3054 02:13:29,832 --> 02:13:30,966 ORIGINALLY THOUGHT I HAD MORE 3055 02:13:30,966 --> 02:13:33,369 THAN FIVE MINUTES SO THE SLIDES 3056 02:13:33,369 --> 02:13:38,974 I WENT WERE COVERING BIOMARKERS. 3057 02:13:38,974 --> 02:13:40,509 I THINK THERE'S INCREDIBLE 3058 02:13:40,509 --> 02:13:42,678 PROGRESS BEING MADE ON 3059 02:13:42,678 --> 02:13:46,482 IDENTIFICATION OF BIOMARKERS FOR 3060 02:13:46,482 --> 02:13:46,716 TDP43. 3061 02:13:46,716 --> 02:13:49,852 WE DO HAVE THE ALPHASIN IT'S A 3062 02:13:49,852 --> 02:13:54,156 YES OR NO ANSWER. 3063 02:13:54,156 --> 02:13:58,227 IT'S NOT QUANTIFIABLE AND 3064 02:13:58,227 --> 02:14:01,564 DOESN'T GIVE REGIONAL 3065 02:14:01,564 --> 02:14:02,398 INFORMATION BUT AT LEAST 3066 02:14:02,398 --> 02:14:02,665 PROGRESS. 3067 02:14:02,665 --> 02:14:05,368 THERE'S NOVEL APPROACHES FOR 3068 02:14:05,368 --> 02:14:10,973 TDP43 ONE OF WHICH IS LOOKING AT 3069 02:14:10,973 --> 02:14:13,008 CRYPTIC PEPTIDES PRODUCED 3070 02:14:13,008 --> 02:14:15,978 BECAUSE THE TDP IS NOW 3071 02:14:15,978 --> 02:14:17,246 DYSFUNCTIONAL IN THE BRAIN. 3072 02:14:17,246 --> 02:14:20,416 YOU GET PEPTIDE CAN BE MEASURED 3073 02:14:20,416 --> 02:14:23,018 IN CSF AND PLASMA. 3074 02:14:23,018 --> 02:14:24,754 THAT'S AN INTERESTING BIOMARKER 3075 02:14:24,754 --> 02:14:25,121 APPROACH. 3076 02:14:25,121 --> 02:14:27,123 THERE'S GOING TO BE MANY OTHERS. 3077 02:14:27,123 --> 02:14:30,025 I WOULD SAY THERE'S INCREDIBLE 3078 02:14:30,025 --> 02:14:31,026 PROGRESS BEING MADE ON THESE AND 3079 02:14:31,026 --> 02:14:33,963 IF WE'RE GOING TO GET TO A 3080 02:14:33,963 --> 02:14:35,264 PRECISION MEDICINE PLACE WE'RE 3081 02:14:35,264 --> 02:14:36,499 GOING TO NEED BIOMARKERS FOR ALL 3082 02:14:36,499 --> 02:14:41,537 OF THESE DIFFERENT PATHOLOGIES 3083 02:14:41,537 --> 02:14:44,306 SO THAT WE CAN CONSIDER WHAT THE 3084 02:14:44,306 --> 02:14:46,008 RELATIVE CONTRIBUTION OF EACH OF 3085 02:14:46,008 --> 02:14:48,611 THOSE ARE TO THE OVER ALL 3086 02:14:48,611 --> 02:14:50,513 COGNITIVE CLINICAL PRESENTATION 3087 02:14:50,513 --> 02:15:00,122 OF THE PATIENTS. 3088 02:15:00,122 --> 02:15:01,056 >> SOMETHING ABOUT THE SECOND 3089 02:15:01,056 --> 02:15:01,857 QUESTION IT'S MORE COMPLICATED 3090 02:15:01,857 --> 02:15:05,261 THAN THAT BECAUSE IF YOU LOOK AT 3091 02:15:05,261 --> 02:15:07,296 THE DIFFERENT BRAIN REGIONS 3092 02:15:07,296 --> 02:15:10,166 YOU'LL SEE HETEROGENEITY IN THE 3093 02:15:10,166 --> 02:15:11,367 SAME PERSON ABOUT THE AMOUNT AND 3094 02:15:11,367 --> 02:15:14,703 TYPE OF PATHOLOGIES. 3095 02:15:14,703 --> 02:15:21,544 THOUGH IT CONTINUES TO BE THE 3096 02:15:21,544 --> 02:15:22,711 DEFINITIVE DIAGNOSES FOR THE 3097 02:15:22,711 --> 02:15:25,314 DISORDERS MAYBE THERE'S A SECOND 3098 02:15:25,314 --> 02:15:26,715 LAYER BECAUSE THE SECOND 3099 02:15:26,715 --> 02:15:28,784 PATHOLOGY COULD BE ARRIVED UPON 3100 02:15:28,784 --> 02:15:33,589 BY DIFFERENT MOLECULAR PATHWAYS. 3101 02:15:33,589 --> 02:15:34,690 UNDER CLEAR AD WE'LL LOOK AT 3102 02:15:34,690 --> 02:15:39,962 COHORTS IN WHICH WE HAVE BOTH 3103 02:15:39,962 --> 02:15:45,034 AUTOPSY MATERIAL AND 3104 02:15:45,034 --> 02:15:46,735 ANTI-MORTEM, LONGITUDINALLY 3105 02:15:46,735 --> 02:15:48,103 COLLECTED PERIPHERAL BLOOD AND 3106 02:15:48,103 --> 02:15:50,706 WE'LL BE ABLE TO CONNECT THE 3107 02:15:50,706 --> 02:15:52,041 MOLECULAR PATHWAYS WHICH IS 3108 02:15:52,041 --> 02:15:52,875 GOING TO BE ESSENTIAL AND FOR 3109 02:15:52,875 --> 02:15:58,714 THE DONORS IN SEVEN BRAIN 3110 02:15:58,714 --> 02:15:58,981 REGIONS. 3111 02:15:58,981 --> 02:16:00,916 COMPARISON FROM DONOR TO DONOR 3112 02:16:00,916 --> 02:16:03,252 AND FROM EACH WITH A DIFFERENT 3113 02:16:03,252 --> 02:16:03,519 REGION. 3114 02:16:03,519 --> 02:16:05,354 AS TO THE MINUS 80 QUESTION IT 3115 02:16:05,354 --> 02:16:07,723 DEPENDS ON WHAT YOU'RE 3116 02:16:07,723 --> 02:16:09,358 MEASURING, HOW YOU'RE MEASURING 3117 02:16:09,358 --> 02:16:10,359 AND ALL OF THAT. 3118 02:16:10,359 --> 02:16:12,862 I THINK SOMETHING THAT WE NEED 3119 02:16:12,862 --> 02:16:20,436 TO BE THINKING VERY CAREFULLY 3120 02:16:20,436 --> 02:16:23,172 ABOUT WAS WHAT MATHIAS MENTIONED 3121 02:16:23,172 --> 02:16:27,576 IT COMES BEFORE THE INNOVATIVE 3122 02:16:27,576 --> 02:16:29,211 QUESTIONS OF THE DATA AND HOW DO 3123 02:16:29,211 --> 02:16:32,548 WE GET AND STORE THE SAMPLES. 3124 02:16:32,548 --> 02:16:33,682 WE NEED TO PAY CAREFUL ATTENTION 3125 02:16:33,682 --> 02:16:35,351 TO THE STANDARD OPERATING 3126 02:16:35,351 --> 02:16:36,018 PROCEDURES. 3127 02:16:36,018 --> 02:16:37,453 THEY MAY NOT BE GLORIOUS BUT 3128 02:16:37,453 --> 02:16:40,055 THEY'RE ESSENTIAL FOR US TO BE 3129 02:16:40,055 --> 02:16:41,357 ABLE TO GET USABLE DATA. 3130 02:16:41,357 --> 02:16:43,926 WE NEED TO MAKE THESE BROADLY 3131 02:16:43,926 --> 02:16:44,793 AVAILABLE. 3132 02:16:44,793 --> 02:16:46,862 WE NEED TO MAKE AVAILABLE OUR 3133 02:16:46,862 --> 02:16:51,033 METADATA OF HOW WE COLLECTED THE 3134 02:16:51,033 --> 02:16:52,768 SAMPLES AND HOW WE PROCESS THEM 3135 02:16:52,768 --> 02:16:55,671 AND THEN HOW WE ANALYZE THEM. 3136 02:16:55,671 --> 02:16:58,574 WE NEED TO CAREFULLY THINK ABOUT 3137 02:16:58,574 --> 02:17:01,210 THE VARIABLES THAT CONTRIBUTE TO 3138 02:17:01,210 --> 02:17:03,679 THE VARIABILITY OF THE SIGNAL 3139 02:17:03,679 --> 02:17:05,748 WE'RE GETTING, TAKE THAT INTO 3140 02:17:05,748 --> 02:17:07,349 ACCOUNT BEFORE WE DO ALL SORTS 3141 02:17:07,349 --> 02:17:10,185 OF COMPARISONS. 3142 02:17:10,185 --> 02:17:12,655 NOT A DEFINITIVE ANSWER OF DON'T 3143 02:17:12,655 --> 02:17:14,456 USE ANYTHING BEYOND THIS MANY 3144 02:17:14,456 --> 02:17:15,758 YEARS BECAUSE IT'S VARIABLE AND 3145 02:17:15,758 --> 02:17:18,694 YOU NEED TO DETECT THE EXTENT OF 3146 02:17:18,694 --> 02:17:19,228 VARIABILITY. 3147 02:17:19,228 --> 02:17:22,097 >> I'M GOING TO GIVE ERIN 10 3148 02:17:22,097 --> 02:17:24,366 SECONDS AND RHODA 10 SECONDS AND 3149 02:17:24,366 --> 02:17:26,268 THEN WE'RE WRAPPING UP SO WE GET 3150 02:17:26,268 --> 02:17:28,337 A BREAK. 3151 02:17:28,337 --> 02:17:32,341 >> I COMPLETELY AGREE. 3152 02:17:32,341 --> 02:17:34,710 I ENCOURAGE THE PERSON ASKING TO 3153 02:17:34,710 --> 02:17:36,645 REACH OUT TO THE ASSAY PLATFORM 3154 02:17:36,645 --> 02:17:37,279 PROVIDER. 3155 02:17:37,279 --> 02:17:39,548 THEY SHOULD HAVE THAT DATA 3156 02:17:39,548 --> 02:17:39,815 AVAILABLE. 3157 02:17:39,815 --> 02:17:44,987 IT'S PART OF THE ANALYTICAL V 3158 02:17:44,987 --> 02:17:45,621 VALIDA 3159 02:17:45,621 --> 02:17:45,921 VALIDATION. 3160 02:17:45,921 --> 02:17:49,091 >> ON THE DIGITAL FRONT, DIGITAL 3161 02:17:49,091 --> 02:17:49,892 IS THE NEW BLOOD. 3162 02:17:49,892 --> 02:17:51,427 YOU'LL BE ABLE TO TAKE THE 3163 02:17:51,427 --> 02:17:54,897 DIGITAL DATA AND BE ABLE TO 3164 02:17:54,897 --> 02:17:57,800 RE-ANALYZE IT MANY DIFFERENT 3165 02:17:57,800 --> 02:17:58,767 WAYS IN ORDER TO DEVELOP THESE 3166 02:17:58,767 --> 02:18:02,037 BIOMARKERS OF INTEREST. 3167 02:18:02,037 --> 02:18:03,439 >> OKAY. 3168 02:18:03,439 --> 02:18:06,442 WITH THAT WE'LL CLOSE THE 3169 02:18:06,442 --> 02:18:08,978 SESSION AND RECONVENE AT 11:00. 3170 02:18:08,978 --> 02:18:09,678 IS THAT RIGHT? 3171 02:18:09,678 --> 02:18:10,713 SO 11:00. 3172 02:18:10,713 --> 02:18:11,213 THANK YOU SO MUCH. 3173 02:18:11,213 --> 02:18:11,313 3174 02:18:23,593 --> 02:18:25,194 >> WE'VE SEEN BRILLIANT 3175 02:18:25,194 --> 02:18:26,996 ENGINEERING TO REMOVE AND 3176 02:18:26,996 --> 02:18:27,830 CONNECT PARTS AND IN THIS 3177 02:18:27,830 --> 02:18:30,600 SESSION I HOPE WE CAN BRING THE 3178 02:18:30,600 --> 02:18:32,368 POWER OF THIS BIG DATA AND THE 3179 02:18:32,368 --> 02:18:35,004 DEVELOPMENTS THAT CAME OUT OF 3180 02:18:35,004 --> 02:18:45,548 OPEN SCIENCE TO EVEN ACCELERATE 3181 02:18:48,418 --> 02:18:51,087 DUE TO OPEN SCIENCE WE'VE SEEN 3182 02:18:51,087 --> 02:18:52,755 REPOSITORIES OF BIG DATA 3183 02:18:52,755 --> 02:18:56,726 GENERATED WITH SIGNIFICANT 3184 02:18:56,726 --> 02:19:00,897 FUNDING, OMICS DATA I COPY FROM 3185 02:19:00,897 --> 02:19:06,335 THE SLIDE AND WE ARE GOING TO 3186 02:19:06,335 --> 02:19:10,406 TALK ABOUT WHAT WE LEARNED AND 3187 02:19:10,406 --> 02:19:12,708 HOW DID WE SHARE AND WHAT ARE 3188 02:19:12,708 --> 02:19:14,710 LIMITATIONS WE ENCOUNTERED AND 3189 02:19:14,710 --> 02:19:17,513 WHAT CAN BE DONE BETTER. 3190 02:19:17,513 --> 02:19:19,048 WE'LL HEAR FROM A SERIES OF 3191 02:19:19,048 --> 02:19:20,316 SPEAKERS ON THE ADVANTAGES AND 3192 02:19:20,316 --> 02:19:21,851 LIMITATIONS THAT REMAIN FROM THE 3193 02:19:21,851 --> 02:19:23,386 INITIAL SERIES OF REPOSITORIES 3194 02:19:23,386 --> 02:19:26,489 THAT HAVE BEEN PUT TOGETHER THAT 3195 02:19:26,489 --> 02:19:29,058 ENABLE SHARING OF BIG DATA AND 3196 02:19:29,058 --> 02:19:30,893 CERTAINLY RESULTED IN MAJOR NEW 3197 02:19:30,893 --> 02:19:31,627 INSIGHTS. 3198 02:19:31,627 --> 02:19:33,830 AS WE LOOK FORWARD WE ALREADY 3199 02:19:33,830 --> 02:19:35,164 HEARD FROM THE SESSION 3200 02:19:35,164 --> 02:19:36,732 PROCEEDING THIS AND THROUGHOUT 3201 02:19:36,732 --> 02:19:38,634 THE PAST TWO DAYS THE DATA THAT 3202 02:19:38,634 --> 02:19:41,070 WE ENVISION THAT IS GOING TO 3203 02:19:41,070 --> 02:19:44,106 COME NEXT IS A WHOLE AREA OF 3204 02:19:44,106 --> 02:19:48,511 DATA FROM CHEMICAL EXPOSURES, 3205 02:19:48,511 --> 02:19:52,748 DATABASES ON PHOTOMICS AND 3206 02:19:52,748 --> 02:19:54,650 THINGS WE INGEST AND THINGS WE 3207 02:19:54,650 --> 02:19:59,689 TAKE AND ASSOCO -- SOCIO 3208 02:19:59,689 --> 02:20:01,757 ECONOMIC AND SLEEP PATTERNS AN 3209 02:20:01,757 --> 02:20:04,727 MOVE FROM STATIC DATA THAT IS 3210 02:20:04,727 --> 02:20:06,062 MORE DYNAMIC AND TRULY 3211 02:20:06,062 --> 02:20:08,898 REPRESENTATIVE ON OUR METABOLIC 3212 02:20:08,898 --> 02:20:10,066 HEALTH AND I'M A BIG ADVOCATE 3213 02:20:10,066 --> 02:20:14,604 FOR METABOLOMICS BECAUSE WE LEAD 3214 02:20:14,604 --> 02:20:15,505 A METABOLOMICS CONSORTIUM AND 3215 02:20:15,505 --> 02:20:17,273 IT'S DYNAMIC AND CAPTURES 3216 02:20:17,273 --> 02:20:19,041 INFLUENCES ON HEALTH IN REAL 3217 02:20:19,041 --> 02:20:19,342 TIME. 3218 02:20:19,342 --> 02:20:22,612 THE ELECTRONIC MEDICAL RECORDS, 3219 02:20:22,612 --> 02:20:24,747 THE DIGITAL RECORDINGS AND POWER 3220 02:20:24,747 --> 02:20:27,717 OF CONNECTING OUR SENSORS WHEN 3221 02:20:27,717 --> 02:20:29,385 OF US HAVE INCLUDING MYSELF. 3222 02:20:29,385 --> 02:20:30,353 I MONITOR A LOT OF THINGS ABOUT 3223 02:20:30,353 --> 02:20:32,755 MY HEALTH, CONNECTING ALL THIS 3224 02:20:32,755 --> 02:20:34,991 WITH MY METABOLOMIC PROFILE 3225 02:20:34,991 --> 02:20:36,392 TAUGHT ME PERSONALLY HOW TO LIVE 3226 02:20:36,392 --> 02:20:37,994 AND EAT BETTER. 3227 02:20:37,994 --> 02:20:39,595 I HOPE THIS WILL OVERCOME MY 3228 02:20:39,595 --> 02:20:41,364 GENETIC SUSCEPTIBILITIES. 3229 02:20:41,364 --> 02:20:43,366 WE'LL SEE A WHOLE AREA OF NEW 3230 02:20:43,366 --> 02:20:44,367 DATA COMING IN. 3231 02:20:44,367 --> 02:20:49,338 DRUGS RESPONSE AND VARIATIONS OF 3232 02:20:49,338 --> 02:20:51,007 RESPONSE, CLINICAL TRIALS THAT 3233 02:20:51,007 --> 02:20:52,408 FAILED OR SUCCEEDED AND DRUGS ON 3234 02:20:52,408 --> 02:20:55,211 THE MARKET, WHO IS ON IT? 3235 02:20:55,211 --> 02:20:57,179 HOW ARE THEY DOING? 3236 02:20:57,179 --> 02:21:00,216 WE'LL HEAR ABOUT THIS AS PART OF 3237 02:21:00,216 --> 02:21:02,351 THE FUTURE AND MOVING FORWARD 3238 02:21:02,351 --> 02:21:03,686 AND THINKING GLOBALLY IT'S 3239 02:21:03,686 --> 02:21:05,388 CRITICAL NO MATTER HOW BIG DATA 3240 02:21:05,388 --> 02:21:07,323 WE PRODUCE THE POWER OF 3241 02:21:07,323 --> 02:21:10,026 CONNECTING ALL OF US AND OUR 3242 02:21:10,026 --> 02:21:10,893 DATA SETS IS POWERFUL. 3243 02:21:10,893 --> 02:21:12,695 AS WE LOOK FORWARD, PART OF THE 3244 02:21:12,695 --> 02:21:15,164 THINGS WE WANT TO DISCUSSION IN 3245 02:21:15,164 --> 02:21:16,732 THE SESSION ARE WE READY TO 3246 02:21:16,732 --> 02:21:18,868 THINK ABOUT DATA THAT DOESN'T 3247 02:21:18,868 --> 02:21:19,235 MOVE? 3248 02:21:19,235 --> 02:21:20,303 DATA THAT IS STATIONARY AND 3249 02:21:20,303 --> 02:21:23,005 WHERE WE CAN VISIT THE DATA, DO 3250 02:21:23,005 --> 02:21:26,342 WHAT WE NEED TO DO IN THE CLOUD 3251 02:21:26,342 --> 02:21:28,544 AND ALL OF OUR COMPUTATIONS. 3252 02:21:28,544 --> 02:21:30,212 IS THIS THE RIGHT THING TO DO 3253 02:21:30,212 --> 02:21:31,681 MOVING FORWARD. 3254 02:21:31,681 --> 02:21:34,584 OUR EXPERTS WILL TACKLE THIS AND 3255 02:21:34,584 --> 02:21:36,285 WE HAVE TO ADOPT WHAT WAS 3256 02:21:36,285 --> 02:21:38,254 INITIALLY PIONEERED AND 3257 02:21:38,254 --> 02:21:39,989 INNOVATED BY THE DUTCH. 3258 02:21:39,989 --> 02:21:40,957 WE WORKED CLOSELY WITH THE DUTCH 3259 02:21:40,957 --> 02:21:44,760 ON TE THE DATA AND THE CONCEPT 3260 02:21:44,760 --> 02:21:47,630 OF THE DIGITAL TWINNING TO 3261 02:21:47,630 --> 02:21:49,332 PARTICIPATE AND SHARE THE DATA 3262 02:21:49,332 --> 02:21:55,204 THEY WANT AND THE ISSUE OF 3263 02:21:55,204 --> 02:21:56,072 EMPOWERING INDIVIDUALS. 3264 02:21:56,072 --> 02:21:58,207 AND WE INTO HE HAD TO GIVE MORE 3265 02:21:58,207 --> 02:22:01,944 POWER TO THE INDIVIDUALS IN 3266 02:22:01,944 --> 02:22:02,812 CONTROLLING THEIR DATA WITHOUT 3267 02:22:02,812 --> 02:22:04,347 DISRUPTING ANALYSES WE WANT TO 3268 02:22:04,347 --> 02:22:04,513 DO. 3269 02:22:04,513 --> 02:22:05,414 THE CLOUD COMPUTING AND 3270 02:22:05,414 --> 02:22:07,183 RESOURCES NEEDED. 3271 02:22:07,183 --> 02:22:09,952 WHO IS LIKE ME WAS AN ISSUE 3272 02:22:09,952 --> 02:22:11,020 BROUGHT UP BY THE ADVOCACY 3273 02:22:11,020 --> 02:22:11,253 GROUPS. 3274 02:22:11,253 --> 02:22:12,655 WE BELIEVE IN IT. 3275 02:22:12,655 --> 02:22:13,322 WE WORK ON IT. 3276 02:22:13,322 --> 02:22:15,057 WE WANT TO BE ABLE TO CONNECT, 3277 02:22:15,057 --> 02:22:18,861 INFORM THE PATIENTS THROUGH THIS 3278 02:22:18,861 --> 02:22:21,464 BIG DATA AND WHO MIGHT RESPOND 3279 02:22:21,464 --> 02:22:25,067 LIKE THEM IS KEY. 3280 02:22:25,067 --> 02:22:27,069 INTEROPERABILITY BETWEEN THE 3281 02:22:27,069 --> 02:22:28,304 MEGA PLATFORMS ARE IMPORTANT. 3282 02:22:28,304 --> 02:22:29,038 SUSTAINABILITY OF THE RESOURCES 3283 02:22:29,038 --> 02:22:30,306 AND WHAT IT TAKES TO SUSTAIN 3284 02:22:30,306 --> 02:22:35,077 THEM IS A TOPIC OF DISCUSSION. 3285 02:22:35,077 --> 02:22:36,746 ENFORCING STANDARDS DOESN'T 3286 02:22:36,746 --> 02:22:37,213 WORK. 3287 02:22:37,213 --> 02:22:38,481 WE CANNOT FORCE SPEAKERS TO 3288 02:22:38,481 --> 02:22:39,682 FOLLOW STANDARDS. 3289 02:22:39,682 --> 02:22:41,450 THE NEXT BEST THING IS TO COME 3290 02:22:41,450 --> 02:22:43,386 UP WITH DATA HARMONIZATION 3291 02:22:43,386 --> 02:22:45,454 APPROACHES FOR ALL THE DATA WE 3292 02:22:45,454 --> 02:22:47,523 GENERATE INCLUDING OUR 3293 02:22:47,523 --> 02:22:49,425 METABOLOMICS AND OTHER OMICS IS 3294 02:22:49,425 --> 02:22:52,728 SOMETHING WE ARE WORKING ON SO 3295 02:22:52,728 --> 02:22:55,031 THIS TOPIC IS KEY THE DYNAMIC 3296 02:22:55,031 --> 02:22:57,400 DATA WE TALKED ABOUT IT GLOBAL 3297 02:22:57,400 --> 02:23:00,770 AND MOVING BOUNDARIES SO WE CAN 3298 02:23:00,770 --> 02:23:02,838 ACCELERATE AND REAL LIFE DATA OF 3299 02:23:02,838 --> 02:23:04,240 COURSE IS CENTRAL BUT MOVING 3300 02:23:04,240 --> 02:23:06,709 FORWARD WHAT I HAVE SEEN IN THE 3301 02:23:06,709 --> 02:23:09,445 SUMMIT AND WHAT I HAVE SEEN AS 3302 02:23:09,445 --> 02:23:10,579 BRILLIANT ENGINEERING THROUGH 3303 02:23:10,579 --> 02:23:14,450 THE PAST DECADE BY WORK WITH NIA 3304 02:23:14,450 --> 02:23:17,520 AND BEING FUNDED THROUGH LARGE 3305 02:23:17,520 --> 02:23:21,957 INITIATIVES WE ARE MOVING 3306 02:23:21,957 --> 02:23:22,258 BOUNDARIES. 3307 02:23:22,258 --> 02:23:26,462 ALZHEIMER'S ALL OF A SUDDEN IS 3308 02:23:26,462 --> 02:23:28,531 DEPRESSION AND PARKINSON'S AND 3309 02:23:28,531 --> 02:23:33,436 THE MORE WE LOOK AT BIG DATA 3310 02:23:33,436 --> 02:23:35,304 MORE COMMON AND HAVING INSTITUTE 3311 02:23:35,304 --> 02:23:36,739 SUPPORT THIS OR NOT IS PERHAPS 3312 02:23:36,739 --> 02:23:38,874 NOT OPTIMAL. 3313 02:23:38,874 --> 02:23:41,477 THERE'S A LOT OF COMMON AND 3314 02:23:41,477 --> 02:23:44,747 LEARN FROM THE EXPERIENCES, 3315 02:23:44,747 --> 02:23:46,282 CONNECT DATA AND RESEARCH 3316 02:23:46,282 --> 02:23:47,616 COMMUNITIES, WORK AS 3317 02:23:47,616 --> 02:23:48,150 COMMUNITIES. 3318 02:23:48,150 --> 02:23:49,985 IT'S A NEW PARADIGM OF DOING 3319 02:23:49,985 --> 02:23:51,821 RESEARCH THAT HAS TRANSFORMED 3320 02:23:51,821 --> 02:23:54,123 AND WE'RE THOUGHT GOING TO GO 3321 02:23:54,123 --> 02:23:54,490 BACK. 3322 02:23:54,490 --> 02:23:56,292 I THINK IT ALREADY WE HAVE MOVED 3323 02:23:56,292 --> 02:24:00,262 FORWARD AND IT'S NO WAY BACK 3324 02:24:00,262 --> 02:24:00,730 INDEED. 3325 02:24:00,730 --> 02:24:02,631 CONNECTING GLOBALLY AND THEN 3326 02:24:02,631 --> 02:24:03,733 FROM DATA TO KNOWLEDGE. 3327 02:24:03,733 --> 02:24:05,301 WE GATHER BIG DATA AT THE END OF 3328 02:24:05,301 --> 02:24:06,368 THE DAY. 3329 02:24:06,368 --> 02:24:09,171 IF WE CANNOT TRANSLATE THIS TO , 3330 02:24:09,171 --> 02:24:09,972 INFORM EACH INDIVIDUAL ABOUT 3331 02:24:09,972 --> 02:24:12,208 THEIR HEALTH, THEIR TRAJECTORY 3332 02:24:12,208 --> 02:24:13,909 FOR DISEASE WE HAVEN'T REALLY 3333 02:24:13,909 --> 02:24:17,012 DONE WHAT WE'RE SUPPOSED TO DO. 3334 02:24:17,012 --> 02:24:19,315 AND HOW WE MOVE FROM BIG DATA TO 3335 02:24:19,315 --> 02:24:19,582 KNOWLEDGE. 3336 02:24:19,582 --> 02:24:24,754 WITH THIS I'M GOING TO MOVE ON 3337 02:24:24,754 --> 02:24:28,290 TO THE FIRST SPEAKER, DR. METTE 3338 02:24:28,290 --> 02:24:28,924 PETERS FROM HIRN AND PRIOR WAS 3339 02:24:28,924 --> 02:24:32,828 AT SABLING AND ENABLED ALL OF US 3340 02:24:32,828 --> 02:24:43,172 THROUGH MANY YEARS. 3341 02:24:52,148 --> 02:24:54,016 >> WE HAVE DATA ENABLEMENT WHEN 3342 02:24:54,016 --> 02:24:55,885 IT COMES TO INFRASTRUCTURE AND 3343 02:24:55,885 --> 02:24:57,052 INTRAOPERABILITY AND HOW TO 3344 02:24:57,052 --> 02:24:58,254 IMPROVE THE USE OF DATA ACROSS 3345 02:24:58,254 --> 02:25:02,258 ALL THESE DATA RESOURCES. 3346 02:25:02,258 --> 02:25:05,694 NOW, THE NIA IS SUPPORTING A 3347 02:25:05,694 --> 02:25:06,762 WHOLE VARIETY OF DIFFERENT 3348 02:25:06,762 --> 02:25:09,431 RESEARCH DATA THAT IS BROADLY 3349 02:25:09,431 --> 02:25:11,667 AVAILABLE TO THE COMMUNITY. 3350 02:25:11,667 --> 02:25:13,369 THIS IS CLEARLY NOT LIMITED TO 3351 02:25:13,369 --> 02:25:15,471 WHAT I HAVE ON THE SLIDE AS YOU 3352 02:25:15,471 --> 02:25:17,139 HEARD OVER THE PAST COUPLE OF 3353 02:25:17,139 --> 02:25:17,540 DAYS. 3354 02:25:17,540 --> 02:25:20,776 THERE'S MANY MANY OTHER DATA 3355 02:25:20,776 --> 02:25:23,045 RESOURCES OUT THERE. 3356 02:25:23,045 --> 02:25:28,350 THIS VARES FROM MOUSE AND ANIMAL 3357 02:25:28,350 --> 02:25:28,584 MODELS. 3358 02:25:28,584 --> 02:25:31,453 IT'S ABOUT THE AVAILABILITY OF 3359 02:25:31,453 --> 02:25:33,155 IN TISSUE RESOURCES AND CELL 3360 02:25:33,155 --> 02:25:37,560 LINES AND CELL TYPE SUCH AS 3361 02:25:37,560 --> 02:25:39,461 IPSCs. 3362 02:25:39,461 --> 02:25:49,205 IT'S DATA FROM LARGE STUDIES AN 3363 02:25:49,205 --> 02:25:52,942 SUPPORTING THE MANAGEMENT AND 3364 02:25:52,942 --> 02:25:55,778 DISTRIBUTION OF THAT DATA. 3365 02:25:55,778 --> 02:25:57,513 THERE'S A WHOLE VARIETY OF TOOLS 3366 02:25:57,513 --> 02:25:59,682 OF DATA PROCESSING AND ANALYSIS 3367 02:25:59,682 --> 02:26:02,218 TOOLS AND DATA VISUALIZATION OR 3368 02:26:02,218 --> 02:26:03,686 QUERY TOOLS THAT AGAIN ARE 3369 02:26:03,686 --> 02:26:04,720 AVAILABLE TO THE RESEARCH 3370 02:26:04,720 --> 02:26:08,691 COMMUNITY. 3371 02:26:08,691 --> 02:26:10,159 WHAT WE'VE HEARD OVER THE PAST 3372 02:26:10,159 --> 02:26:12,628 COUPLE DAYS IS THE IMPORTANCE OF 3373 02:26:12,628 --> 02:26:16,732 THE DATA RESOURCES BEING FAIR. 3374 02:26:16,732 --> 02:26:18,767 SO IS THE DATA AVAILABLE IS IT 3375 02:26:18,767 --> 02:26:22,671 FINDABLE BY HUMANS AND COMPUTERS 3376 02:26:22,671 --> 02:26:23,239 AND MACHINES? 3377 02:26:23,239 --> 02:26:25,908 ONCE YOU FIND THE DATA, IS IT 3378 02:26:25,908 --> 02:26:26,208 ACCESSIBLE? 3379 02:26:26,208 --> 02:26:32,615 IS THERE A STANDARDIZED WAY THAT 3380 02:26:32,615 --> 02:26:36,685 A USER HAS AUTHORIZATION? 3381 02:26:36,685 --> 02:26:40,222 IS THE DATA INTEROPERABLE. 3382 02:26:40,222 --> 02:26:42,992 CAN YOU INTEROPERATE THAT DATA 3383 02:26:42,992 --> 02:26:44,727 WITH SAY OTHER STUDIES OR ACROSS 3384 02:26:44,727 --> 02:26:46,662 DATA MODALITIES. 3385 02:26:46,662 --> 02:26:48,731 CAN YOU OPERATE THAT DATA WITH 3386 02:26:48,731 --> 02:26:52,034 TOOLS THAT IS NECESSARY FOR THE 3387 02:26:52,034 --> 02:26:52,301 ANALYSIS? 3388 02:26:52,301 --> 02:26:55,304 IS THE DATA FORMAT MACHINE 3389 02:26:55,304 --> 02:26:55,804 READABLE FOR EXAMPLE? 3390 02:26:55,804 --> 02:26:59,108 AND CAN YOU REUSE THAT DATA? 3391 02:26:59,108 --> 02:27:04,680 DOES IT HAVE THE NECESSARY STUDY 3392 02:27:04,680 --> 02:27:07,182 METHODS, DESCRIPTION METADATA, 3393 02:27:07,182 --> 02:27:09,451 QC INFORMATION, THE BATCH 3394 02:27:09,451 --> 02:27:11,420 VARIABLES YOU'LL NEED IN ORDER 3395 02:27:11,420 --> 02:27:16,926 TO REALLY TAKE ADVANTAGE OF THAT 3396 02:27:16,926 --> 02:27:17,426 DATA? 3397 02:27:17,426 --> 02:27:23,332 AND THOSE HAVE BEEN VIEWED FROM 3398 02:27:23,332 --> 02:27:24,733 TWO DIFFERENT VIEWS. 3399 02:27:24,733 --> 02:27:27,469 ONE IS FAIRNESS WITHIN DATA 3400 02:27:27,469 --> 02:27:28,103 RESOURCES AND FAIRNESS BETWEEN 3401 02:27:28,103 --> 02:27:31,674 THE DATA RESOURCES. 3402 02:27:31,674 --> 02:27:35,311 AND I WOULD ARGUE THAT NIA 3403 02:27:35,311 --> 02:27:36,812 SUPPORTED DATA RESOURCES MORE OR 3404 02:27:36,812 --> 02:27:40,049 LESS MEET THE FAIR PRINCIPLES 3405 02:27:40,049 --> 02:27:42,117 WITHIN BUT THE FAIRNESS BETWEEN 3406 02:27:42,117 --> 02:27:43,085 IS A MUCH MORE COMPLICATED 3407 02:27:43,085 --> 02:27:45,454 QUESTION. 3408 02:27:45,454 --> 02:27:48,757 AND THERE IS WORK BEING DONE IN 3409 02:27:48,757 --> 02:27:53,262 THAT AREA THAT WE ARE MOVING 3410 02:27:53,262 --> 02:27:54,530 TOWARDS THE ECO SYSTEM AND I 3411 02:27:54,530 --> 02:28:00,602 WANT TO MENTION A COUPLE 3412 02:28:00,602 --> 02:28:00,869 EXAMPLES. 3413 02:28:00,869 --> 02:28:09,745 ONE IS THE NATIONAL ALZHEIMER'S 3414 02:28:09,745 --> 02:28:13,782 DATA CENTER AND SHARING PLATFORM 3415 02:28:13,782 --> 02:28:16,552 ORIGINATING AND INTEGRATING DATA 3416 02:28:16,552 --> 02:28:22,925 FROM IMAGING DATA FROM 3417 02:28:22,925 --> 02:28:26,061 GENOTYPING DATA AND OTHER OMICS 3418 02:28:26,061 --> 02:28:32,434 DATA AND LINKED TO THE SAME 3419 02:28:32,434 --> 02:28:33,836 IDENTIFIER AND MAKE THE DATA 3420 02:28:33,836 --> 02:28:34,503 AVAILABLE FOR RESEARCH USE. 3421 02:28:34,503 --> 02:28:39,174 TO HAVE THE ABILITY TO LINK DATA 3422 02:28:39,174 --> 02:28:41,844 ACROSS RESOURCES. 3423 02:28:41,844 --> 02:28:43,412 SARAH BIBER WILL TALK MORE ABOUT 3424 02:28:43,412 --> 02:28:44,880 THAT IN A BIT. 3425 02:28:44,880 --> 02:28:48,117 THERE'S ALSO EXAMPLES OF LINKING 3426 02:28:48,117 --> 02:28:49,985 DATA FROM RELATED STUDIES. 3427 02:28:49,985 --> 02:28:51,453 THERE'S EFFORTS LINKING DATA 3428 02:28:51,453 --> 02:28:55,257 FROM THE SAME INDIVIDUALS FROM 3429 02:28:55,257 --> 02:28:59,495 AD KNOWLEDGE PORTAL. 3430 02:28:59,495 --> 02:29:02,765 AND DATA IN LONI THAT IS INDEXED 3431 02:29:02,765 --> 02:29:04,733 AND DISCOVERABLE THROUGH THE AD 3432 02:29:04,733 --> 02:29:07,269 KNOWLEDGE PORTAL AND MULTIPLE 3433 02:29:07,269 --> 02:29:08,437 PORTALS HAVE OR IN THE PROCESS 3434 02:29:08,437 --> 02:29:11,673 OF ENABLING THE ACCESS WITH DATA 3435 02:29:11,673 --> 02:29:16,678 FROM THE PORTALS INTO CLOUD WORK 3436 02:29:16,678 --> 02:29:16,912 SPACES. 3437 02:29:16,912 --> 02:29:20,749 AND ENABLE ACCESS TO OTHER DATA 3438 02:29:20,749 --> 02:29:30,959 RESOURCES NOT LIMITED TO AD/A 3439 02:29:30,959 --> 02:29:31,493 DRD DATA. 3440 02:29:31,493 --> 02:29:34,530 AND WE HAVE ADDRESSED IF HE 3441 02:29:34,530 --> 02:29:36,265 QUESTIONS OF FAIRNESS AND CRASS 3442 02:29:36,265 --> 02:29:40,069 THE DATA INFRASTRUCTURES. 3443 02:29:40,069 --> 02:29:42,171 THAT QUESTION OF 3444 02:29:42,171 --> 02:29:42,771 INTEROPERABILITY AND HERE'S 3445 02:29:42,771 --> 02:29:48,310 COMMUNITY INPUT WE GOT THROUGH 3446 02:29:48,310 --> 02:29:48,744 THE WORKSHOP. 3447 02:29:48,744 --> 02:29:54,383 ONE IT'S IMPORTANT TO BUILD ON 3448 02:29:54,383 --> 02:29:55,617 EFFORTS. 3449 02:29:55,617 --> 02:29:56,752 THE QUESTION OF FINDABILITY. 3450 02:29:56,752 --> 02:29:57,753 DOESN'T MATTER WHAT DATA 3451 02:29:57,753 --> 02:29:58,454 RESOURCES ARE OUT THERE IF YOU 3452 02:29:58,454 --> 02:30:00,122 CAN'T FIND THEM. 3453 02:30:00,122 --> 02:30:02,925 AND THAT CAME UP VERY 3454 02:30:02,925 --> 02:30:03,225 FREQUENTLY. 3455 02:30:03,225 --> 02:30:04,726 IT'S IMPORTANT TO THINK ABOUT 3456 02:30:04,726 --> 02:30:05,794 BUILDING CENTRALIZED DATA 3457 02:30:05,794 --> 02:30:16,171 DISCOVERY AND SEARCH. 3458 02:30:28,584 --> 02:30:32,754 WE HAD AN IN DEPTH DISCUSSION 3459 02:30:32,754 --> 02:30:36,725 OF A.I. AND ENHANCING FOR DATA 3460 02:30:36,725 --> 02:30:38,994 LINKAGES THINKING THE WHOLE LIFE 3461 02:30:38,994 --> 02:30:40,729 SPAN EXPOSOME AND DIGITAL HEALTH 3462 02:30:40,729 --> 02:30:41,263 TECHNOLOGIES. 3463 02:30:41,263 --> 02:30:43,732 THE LINKING TO IMAGING AND OMICS 3464 02:30:43,732 --> 02:30:44,066 DATA. 3465 02:30:44,066 --> 02:30:47,469 WE NEED A WAY OF PRESERVING THE 3466 02:30:47,469 --> 02:30:50,672 PRIVACY OF THAT DATA BUT ALSO 3467 02:30:50,672 --> 02:30:56,778 ENABLE THAT ABILITY TO LINK THE 3468 02:30:56,778 --> 02:30:58,380 DATA TOGETHER. 3469 02:30:58,380 --> 02:30:59,681 AND EDUCATION ON TRAINING 3470 02:30:59,681 --> 02:31:01,350 RESOURCES WHEN IT COMES TO CLOUD 3471 02:31:01,350 --> 02:31:04,019 COMPUTE AND TO MAKE THE MODEL 3472 02:31:04,019 --> 02:31:06,088 SYSTEM DATA TO MAKE THEM BETTER 3473 02:31:06,088 --> 02:31:12,728 KNOWN AND ACCESSIBLE AND 3474 02:31:12,728 --> 02:31:14,530 INTEROPERABLE AND LAST BUT NOT 3475 02:31:14,530 --> 02:31:15,898 LEAST THE IMPORTANCE OF 3476 02:31:15,898 --> 02:31:19,101 FOSTERING DIVERSITY, EQUITY, 3477 02:31:19,101 --> 02:31:23,005 INCLUSIVITY AND ACCESSIBILITY 3478 02:31:23,005 --> 02:31:24,740 BOTH IN REPRESENTATION OF THE 3479 02:31:24,740 --> 02:31:26,275 COMMUNITIES THE DATA REPRESENT 3480 02:31:26,275 --> 02:31:33,382 AND THE USERS OF THE DATA AND 3481 02:31:33,382 --> 02:31:36,051 ALSO BEYOND CARE. 3482 02:31:36,051 --> 02:31:37,219 DON'T FORGET THE COLLECTIVE 3483 02:31:37,219 --> 02:31:39,154 BENEFITS OF THE DATA AND THE 3484 02:31:39,154 --> 02:31:40,122 AUTHORITY TO CONTROL THE 3485 02:31:40,122 --> 02:31:43,492 RESPONSIBILITY AND THE AFFECTS. 3486 02:31:43,492 --> 02:31:46,762 NOW, IF WE ARE GOING TO MANAGE 3487 02:31:46,762 --> 02:31:49,932 THIS WE DO NEED STANDARDS. 3488 02:31:49,932 --> 02:31:51,366 SO LOOKING AT THE STANDARDS AN 3489 02:31:51,366 --> 02:31:56,738 PEOPLE TO ADOPT SOME STANDARDS. 3490 02:31:56,738 --> 02:32:00,976 THE NIA DATA RESOURCES ARE 3491 02:32:00,976 --> 02:32:04,313 DISTRIBUTED ACROSS A VARIETY OF 3492 02:32:04,313 --> 02:32:04,947 REPOSITORIES AND THERE'S DATA 3493 02:32:04,947 --> 02:32:06,448 BEYOND THE ECO SYSTEM. 3494 02:32:06,448 --> 02:32:10,285 SO WE NEED THE ABILITY TO LINK. 3495 02:32:10,285 --> 02:32:12,721 WE NEED STANDARDS THAT CAN LINK 3496 02:32:12,721 --> 02:32:15,490 THIS DATA. 3497 02:32:15,490 --> 02:32:16,725 AND THERE ARE MULTIPLE 3498 02:32:16,725 --> 02:32:20,429 INITIATIVES DEVELOPING THE 3499 02:32:20,429 --> 02:32:24,733 STANDARDS AND GENOMICS AND 3500 02:32:24,733 --> 02:32:28,437 HEALTH THE POLICY ORGANIZATION 3501 02:32:28,437 --> 02:32:30,973 AND THE NIH CLOUD PLATFORM 3502 02:32:30,973 --> 02:32:36,745 INTEROPERABILITY PROGRAM AND 3503 02:32:36,745 --> 02:32:38,981 NCBI SORT OF IMPLEMENTING OTHER 3504 02:32:38,981 --> 02:32:44,720 STANDARDS IN CREATING A 3505 02:32:44,720 --> 02:32:47,089 FEDERATED SYSTEM AND STANDARDS 3506 02:32:47,089 --> 02:32:49,925 THE HL7 FIRE STANDARD 3507 02:32:49,925 --> 02:32:50,492 FACILITATES THE EXCHANGE OF 3508 02:32:50,492 --> 02:32:55,030 HEALTH CARE INFORMATION. 3509 02:32:55,030 --> 02:32:57,299 NOW, I'LL TALK ABOUT A SPECIFIC 3510 02:32:57,299 --> 02:33:00,402 EXAMPLE OF DATA INTEGRATION IN 3511 02:33:00,402 --> 02:33:05,274 APPLICATION OF STANDARDS. 3512 02:33:05,274 --> 02:33:07,909 THAT IS BASED ON THE 3513 02:33:07,909 --> 02:33:10,779 ACCELERATING MEDICINE 3514 02:33:10,779 --> 02:33:11,079 INITIATIVE. 3515 02:33:11,079 --> 02:33:13,482 IT'S GENERATED UNPRECEDENTED 3516 02:33:13,482 --> 02:33:16,351 AMOUNTS OF DATA FROM 3517 02:33:16,351 --> 02:33:17,152 ALZHEIMER'S, PARKINSON'S AND 3518 02:33:17,152 --> 02:33:18,720 SCHIZOPHRENIA AND OTHER 3519 02:33:18,720 --> 02:33:19,554 DISEASES. 3520 02:33:19,554 --> 02:33:20,489 THIS PROVIDES AN OPPORTUNITY TO 3521 02:33:20,489 --> 02:33:22,924 TAKE ADVANTAGE OF THE DATA TO 3522 02:33:22,924 --> 02:33:25,127 LOOK AT COMMONALITIES ACROSS 3523 02:33:25,127 --> 02:33:28,864 THESE DISEASES AND ALSO 3524 02:33:28,864 --> 02:33:30,265 DIFFERENCES ACROSS THE DISEASES 3525 02:33:30,265 --> 02:33:32,634 BY TAKING A LARGE SCALE NETWORK 3526 02:33:32,634 --> 02:33:34,469 ANALYSIS APPROACH. 3527 02:33:34,469 --> 02:33:36,038 TO DO THIS THOUGH WELL FIRST OF 3528 02:33:36,038 --> 02:33:39,474 ALL THIS HAS LED TO WHAT IS 3529 02:33:39,474 --> 02:33:41,209 CALLED THE BIOLOGY OF 3530 02:33:41,209 --> 02:33:42,611 INFLAMMATION WHICH IS A CONCEPT 3531 02:33:42,611 --> 02:33:48,717 PROPOSED TO LEVERAGE DATA FROM 3532 02:33:48,717 --> 02:33:54,623 EXISTING PROGRAMS AND BIOLOGY 3533 02:33:54,623 --> 02:33:56,658 AND ANALYSIS AND INCREASE THE 3534 02:33:56,658 --> 02:33:57,592 INTEROPERABILITY OF DATA AND 3535 02:33:57,592 --> 02:34:00,228 BEING ABLE TO IDENTIFY OR BUILD 3536 02:34:00,228 --> 02:34:02,464 THE PROTECTIVE MODEL OF 3537 02:34:02,464 --> 02:34:04,733 INFLAMMATION COMMON AND SPECIFIC 3538 02:34:04,733 --> 02:34:09,471 TO DISEASES IN IDENTIFY 3539 02:34:09,471 --> 02:34:12,741 INFLAMMATORY AND IMMUNE 3540 02:34:12,741 --> 02:34:23,285 SIGNATURES -- THE NIH TO ADDRESS 3541 02:35:05,894 --> 02:35:10,165 CHALLENGES HAS INVESTED UP A 3542 02:35:10,165 --> 02:35:11,133 PROTOTYPE OF INFRASTRUCTURE. 3543 02:35:11,133 --> 02:35:14,035 THIS IS FUNDING OVER THREE YEARS 3544 02:35:14,035 --> 02:35:15,504 THROUGH THE COMMON FUND VENTURE 3545 02:35:15,504 --> 02:35:17,906 PROGRAM WHICH WILL FUND A 3546 02:35:17,906 --> 02:35:20,041 PLATFORM THAT WILL CREATE A 3547 02:35:20,041 --> 02:35:22,310 CENTRALIZED SYSTEM ARCHITECTURE 3548 02:35:22,310 --> 02:35:27,215 FOR FEDERATED DATA SHARING AND 3549 02:35:27,215 --> 02:35:30,919 START DEVELOPING A DATA MODEL 3550 02:35:30,919 --> 02:35:34,689 SCALABLE AND DATA HARMONIZATION 3551 02:35:34,689 --> 02:35:36,691 AND DATA QUERIZATION. 3552 02:35:36,691 --> 02:35:39,194 THE INTENT IS FOR THIS TO BE A 3553 02:35:39,194 --> 02:35:42,898 POWERFUL TOOL ITSELF BUT BE ABLE 3554 02:35:42,898 --> 02:35:46,201 TO SCALE WHAT IS DEVELOPED TO 3555 02:35:46,201 --> 02:35:48,737 AMP SBI AND NEEDS GOING IN THE 3556 02:35:48,737 --> 02:35:58,480 FUTURE 3557 02:35:58,480 --> 02:36:00,849 >> THE NEXT SPEAKER FROM OXFORD 3558 02:36:00,849 --> 02:36:04,486 UNIVERSITY IS DR. GALLACHER AND 3559 02:36:04,486 --> 02:36:06,488 HAVE SEEN EXAMPLES OF SUCCESS OF 3560 02:36:06,488 --> 02:36:07,856 DATA SHARING IN THE U.K. WITH 3561 02:36:07,856 --> 02:36:16,064 THE U.K. BIO BANK AND MORE. 3562 02:36:16,064 --> 02:36:18,133 >> THANK YOU FOR INVITATION AND 3563 02:36:18,133 --> 02:36:20,402 ORGANIZATION AND IT'S A 3564 02:36:20,402 --> 02:36:25,307 PRIVILEGE TO JOIN YOU IN WHAT A 3565 02:36:25,307 --> 02:36:29,744 DESCRIBE AS A VIBRANT COMMUNITY. 3566 02:36:29,744 --> 02:36:34,382 YOU CAN BUILD DIFFERENT 3567 02:36:34,382 --> 02:36:37,085 KNOWLEDGE NETWORKS. 3568 02:36:37,085 --> 02:36:42,324 WE'LL BE TALKING ABOUT HOW WE 3569 02:36:42,324 --> 02:36:43,258 HAVE DEVELOPED DATA PLATFORM 3570 02:36:43,258 --> 02:36:46,161 FOCUSSED ON DATA TRANSLATION AND 3571 02:36:46,161 --> 02:36:51,766 THIS MEANS BRINGING TOGETHER 3572 02:36:51,766 --> 02:36:56,771 COHORT AND BEGINNING TO EXTEND 3573 02:36:56,771 --> 02:37:01,510 INTO LABORATORY DATA. 3574 02:37:01,510 --> 02:37:03,311 FOR INTEREST OF BACKGROUND 3575 02:37:03,311 --> 02:37:06,181 THERE'S THREE LEGS TO THE 3576 02:37:06,181 --> 02:37:07,048 TRIPOD. 3577 02:37:07,048 --> 02:37:12,854 WE HAVE A FRAMEWORK WHICH IS 3578 02:37:12,854 --> 02:37:17,826 ABOUT 64 SITES. 3579 02:37:17,826 --> 02:37:19,995 A LARGE REGISTRY PROBABLY THE 3580 02:37:19,995 --> 02:37:20,862 LARGEST IN THE U.K. 3581 02:37:20,862 --> 02:37:23,164 WE HAVE AN EXPERIMENTAL MEDICINE 3582 02:37:23,164 --> 02:37:25,166 PROGRAM BRIDGING THE GAP BETWEEN 3583 02:37:25,166 --> 02:37:28,069 DISCOVERY AND HELPING COMPANIES 3584 02:37:28,069 --> 02:37:29,704 MAKE DECISION IN TERMS OF DRUG 3585 02:37:29,704 --> 02:37:30,005 DEVELOPMENT. 3586 02:37:30,005 --> 02:37:33,575 I'LL BE TALKING ABOUT OUR DATA 3587 02:37:33,575 --> 02:37:37,178 PORTAL TRYING TO IMPLEMENT MANY 3588 02:37:37,178 --> 02:37:44,586 OF THE THINGS METTE WAS 3589 02:37:44,586 --> 02:37:45,487 DESCRIBING AND WE'RE A 3590 02:37:45,487 --> 02:37:46,121 PUBLIC-PRIVATE PARTNERSHIP AND 3591 02:37:46,121 --> 02:37:56,598 THERE ARE ARE OUR PARTNERS. 3592 02:38:34,903 --> 02:38:37,205 IF YOU'RE A GRAND OLD MAN OR 3593 02:38:37,205 --> 02:38:38,873 WOMEN OF SCIENCE YOU CAN DO WHAT 3594 02:38:38,873 --> 02:38:39,641 YOU WANT. 3595 02:38:39,641 --> 02:38:43,011 IF YOU'RE AN EARLY CAREER 3596 02:38:43,011 --> 02:38:46,481 RESEARCHE 3597 02:38:46,481 --> 02:38:48,717 RESEARCHER IN MALAWI YOU NEED 3598 02:38:48,717 --> 02:38:51,886 PLATFORMS LIKE THIS AND OUR USE 3599 02:38:51,886 --> 02:38:54,456 IS VERY MUCH WITH THE EARLY 3600 02:38:54,456 --> 02:38:56,391 PRE-RESEARCHERS AND RESEARCHERS 3601 02:38:56,391 --> 02:38:58,827 WHO DID NOT COME FROM HIGH END 3602 02:38:58,827 --> 02:38:59,694 COMPUTING ACCESS BACKGROUNDS. 3603 02:38:59,694 --> 02:39:01,463 LET'S LOOK AT THE ARCHITECTURE. 3604 02:39:01,463 --> 02:39:03,164 WE'LL TAKE DATA IN ANY FORMAT 3605 02:39:03,164 --> 02:39:03,999 YOU WANT TO PROVIDE IT. 3606 02:39:03,999 --> 02:39:05,867 THE GOAL IS TO MAKE IT AS EASY 3607 02:39:05,867 --> 02:39:07,268 AS POSSIBLE FOR YOU. 3608 02:39:07,268 --> 02:39:10,338 WE THEN CURATE IT TO STANDARDS 3609 02:39:10,338 --> 02:39:18,513 AND IT DEPEND ON THE MODALITY. 3610 02:39:18,513 --> 02:39:20,081 YOU IT'S INTEROPERABLE WITH 3611 02:39:20,081 --> 02:39:20,649 OTHER PLATFORMS. 3612 02:39:20,649 --> 02:39:23,351 FROM A USERS POINT OF VIEW THE 3613 02:39:23,351 --> 02:39:25,787 DATA BECOMES DISCOVERABLE 3614 02:39:25,787 --> 02:39:27,856 THROUGH A SUITE OF 3615 02:39:27,856 --> 02:39:30,825 DISCOVERABILITY AND BROKER 3616 02:39:30,825 --> 02:39:32,727 ACCESS BETWEEN THE USER AND DATA 3617 02:39:32,727 --> 02:39:34,663 CONTROLLER OR THE DATA PROVIDER. 3618 02:39:34,663 --> 02:39:37,465 SO IF YOU NEEDED TO ACCESS FIVE 3619 02:39:37,465 --> 02:39:39,434 DAT SETS YOU WOULD NEED TO 3620 02:39:39,434 --> 02:39:40,735 CONTACT US ONCE. 3621 02:39:40,735 --> 02:39:42,771 WE THEN DISTRIBUTE THE ACCESS 3622 02:39:42,771 --> 02:39:45,907 REQUEST TO THE DATA CONTROLLERS 3623 02:39:45,907 --> 02:39:50,445 AND BRING REPLIES BACK TO YOU. 3624 02:39:50,445 --> 02:39:52,414 IT MAKES IT A MORE STREAMLINE 3625 02:39:52,414 --> 02:39:54,849 OPERATION BUT THE MEAT IS IN THE 3626 02:39:54,849 --> 02:39:59,087 DATA ANALYSIS LAYER YOU CAN HAVE 3627 02:39:59,087 --> 02:40:04,726 YOUR OWN PRIVATE LABORATORY 3628 02:40:04,726 --> 02:40:07,696 SPACE AND CONFIGURE AND THAT'S 3629 02:40:07,696 --> 02:40:08,730 YOUR PRIVILEGE. 3630 02:40:08,730 --> 02:40:12,734 THE CONFIGURATION IS MORE OF AN 3631 02:40:12,734 --> 02:40:15,336 EXERCISE WE CAN DO ON YOUR 3632 02:40:15,336 --> 02:40:15,570 BEHALF. 3633 02:40:15,570 --> 02:40:16,738 AND WE WILL THEN PROVIDE YOU 3634 02:40:16,738 --> 02:40:19,274 WITH THE TOOLS SO YOU CAN COME 3635 02:40:19,274 --> 02:40:20,709 TO THE DATA. 3636 02:40:20,709 --> 02:40:24,713 DATA NEVER LEAVE AS IN NEVER 3637 02:40:24,713 --> 02:40:30,218 LEAVE THE DATA PORTAL. 3638 02:40:30,218 --> 02:40:31,419 AND WITHIN THE DATA WE CAN 3639 02:40:31,419 --> 02:40:32,554 PROVIDE YOU WITH THE TOOLS YOU 3640 02:40:32,554 --> 02:40:33,354 REQUIRE. 3641 02:40:33,354 --> 02:40:35,323 I DON'T THINK WE'VE COME ACROSS 3642 02:40:35,323 --> 02:40:36,324 ANY SOFTWARE REQUESTS SO FAR 3643 02:40:36,324 --> 02:40:38,993 THAT WE HAVEN'T BEEN ABLE TO 3644 02:40:38,993 --> 02:40:39,227 PROVIDE. 3645 02:40:39,227 --> 02:40:41,629 THIS REALLY REDUCES A 3646 02:40:41,629 --> 02:40:43,565 DUPLICATION OF EFFORT AND COST 3647 02:40:43,565 --> 02:40:46,568 ON BEHALF OF THE SCIENTIFIC 3648 02:40:46,568 --> 02:40:46,835 COMMUNITY. 3649 02:40:46,835 --> 02:40:49,003 AND THEN THE MORE DIFFICULT 3650 02:40:49,003 --> 02:40:50,071 ACCESS IS KNOWLEDGE MANAGEMENT 3651 02:40:50,071 --> 02:40:52,307 ENVIRONMENT BECAUSE IT'S HARD TO 3652 02:40:52,307 --> 02:40:54,442 GET HOLD OF THE KNOWLEDGE IN ANY 3653 02:40:54,442 --> 02:40:56,745 SENSE OF COMPLETENESS. 3654 02:40:56,745 --> 02:41:01,916 TO REITERATE SOME OF THE 3655 02:41:01,916 --> 02:41:07,455 COMMENTS OTHER PEOPLE HAVE MADE 3656 02:41:07,455 --> 02:41:09,557 DATA IS ONE THING AND MEANING IT 3657 02:41:09,557 --> 02:41:10,625 WILL DATA ANOTHER AND DEVELOPED 3658 02:41:10,625 --> 02:41:12,761 PREPROCESSING PIPELINES TO DATA 3659 02:41:12,761 --> 02:41:18,433 THAT RELEVANT TO THE SPECIALISTS 3660 02:41:18,433 --> 02:41:20,468 CAN BE RELEVANT TO A BROADER 3661 02:41:20,468 --> 02:41:20,769 HYPOTHESIS. 3662 02:41:20,769 --> 02:41:22,904 IF YOU'RE A GENETICISTS YOU'D 3663 02:41:22,904 --> 02:41:24,606 LIKE TO SEE THE SEQUENCE POWER 3664 02:41:24,606 --> 02:41:27,008 BUT IF YOU WANT TO LOOK AT 3665 02:41:27,008 --> 02:41:29,944 GENETICS DATA YOU JUST WANT TO 3666 02:41:29,944 --> 02:41:30,879 KNOW THE GENOTYPE AND CAN ARGUE 3667 02:41:30,879 --> 02:41:32,180 THAT IN MANY WAYS. 3668 02:41:32,180 --> 02:41:37,852 I WAS INTERESTED IN THE CORE 3669 02:41:37,852 --> 02:41:43,691 DIGITAL PHENOTYPES. 3670 02:41:43,691 --> 02:41:47,529 THEY'RE CONFUSED AND PEOPLE CAN 3671 02:41:47,529 --> 02:41:48,763 STANDARDIZE THE DATA. 3672 02:41:48,763 --> 02:41:50,765 SO WE NEED TO CREATE RESEARCH 3673 02:41:50,765 --> 02:41:52,500 FOR COHORTS. 3674 02:41:52,500 --> 02:41:54,502 WE HAD SEVERAL GOES AT THIS AND 3675 02:41:54,502 --> 02:41:57,272 FAILED MICHELLY UNTIL WE DECIDED 3676 02:41:57,272 --> 02:42:00,542 TO FOCUS ON DATA DISCOVERY. 3677 02:42:00,542 --> 02:42:08,183 AT THAT POINT THE PROBLEM BECAME 3678 02:42:08,183 --> 02:42:08,583 MANAGEABLE. 3679 02:42:08,583 --> 02:42:11,186 AND CURATE TO A PARTICULAR 3680 02:42:11,186 --> 02:42:13,488 STANDARD AND HAVE 18 THEMES 3681 02:42:13,488 --> 02:42:16,758 BROKEN INTO DOMAINS, FAMILIES 3682 02:42:16,758 --> 02:42:21,596 AND OBJECTS AND THE COGNITIVE 3683 02:42:21,596 --> 02:42:23,631 DATA AND THE VARIABLES. 3684 02:42:23,631 --> 02:42:24,766 THIS HAS INCREDIBLE UTILITY. 3685 02:42:24,766 --> 02:42:27,202 IF YOU WERE TO GO TO A BRAND NEW 3686 02:42:27,202 --> 02:42:28,503 DATA SET WITH AN EXPERIMENT 3687 02:42:28,503 --> 02:42:31,806 WE'VE DONE AND SAY WE WANT TO 3688 02:42:31,806 --> 02:42:32,607 IDENTIFY 25 VARIABLES OF 3689 02:42:32,607 --> 02:42:34,342 INTEREST IT WILL PROBABLY TAKE 3690 02:42:34,342 --> 02:42:35,376 YOU FROM SCRATCH BECAUSE YOUR 3691 02:42:35,376 --> 02:42:39,280 NOT FAMILIAR WITH THE DATA SET 3692 02:42:39,280 --> 02:42:42,116 AND IT'S USUALLY ANNOTATED AND 3693 02:42:42,116 --> 02:42:44,419 IF IT'S IN A STANDARD FORMAT YOU 3694 02:42:44,419 --> 02:42:46,888 ARE FAMILIAR WITH THE SAME WORK 3695 02:42:46,888 --> 02:42:48,523 LOAD TAKES AROUND 15 MINUTES. 3696 02:42:48,523 --> 02:42:49,757 NOW, THIS MEANS WE DEAL WITH THE 3697 02:42:49,757 --> 02:42:52,160 HARD WORK AND DO THE HEAVY 3698 02:42:52,160 --> 02:42:54,796 LIFTING BUT IT HAS INCREDIBLE 3699 02:42:54,796 --> 02:42:55,430 BENEFITS FOR YOURSELVES IN THE 3700 02:42:55,430 --> 02:42:58,867 COMMUNITY. 3701 02:42:58,867 --> 02:43:00,235 THE REAL QUESTION HERE IS DOES 3702 02:43:00,235 --> 02:43:04,005 IT WORK? 3703 02:43:04,005 --> 02:43:07,275 HERE WE HAVE A DASHBOARD WE MAKE 3704 02:43:07,275 --> 02:43:07,709 AVAILABLE PUBLICLY. 3705 02:43:07,709 --> 02:43:09,377 THIS IS AVAILABLE TO OUR FUNDERS 3706 02:43:09,377 --> 02:43:14,716 AND THE USING COMMUNITY. 3707 02:43:14,716 --> 02:43:20,488 WE HAVE AND MANAGE COHORTS AND A 3708 02:43:20,488 --> 02:43:24,759 THOUSAND USERS IN DIFFERENT 3709 02:43:24,759 --> 02:43:29,397 COUNTRIES AND RECEIVED ACCESS 3710 02:43:29,397 --> 02:43:29,864 REQUEST. 3711 02:43:29,864 --> 02:43:32,333 THEY'RE GROWING YEAR ON YEAR. 3712 02:43:32,333 --> 02:43:35,470 WE HAD A DIP IN 2020 WITH COVID 3713 02:43:35,470 --> 02:43:37,238 BUT SO FAR THIS YEAR SURPASSED 3714 02:43:37,238 --> 02:43:42,710 THE 2023 LEVELS OF INTEREST. 3715 02:43:42,710 --> 02:43:44,679 INTERESTINGLY THE STATISTIC I 3716 02:43:44,679 --> 02:43:47,415 LIKE MOST IS THIS ONE HERE BY 3717 02:43:47,415 --> 02:43:49,450 PUBLISHING THE DATA WE GET 3718 02:43:49,450 --> 02:43:50,385 RELATIVELY RAPID TURNAROUND 3719 02:43:50,385 --> 02:43:53,554 TIMES FOR DECISIONS BY THE 3720 02:43:53,554 --> 02:43:56,090 COHORT P.I.s AND THAT IS REALLY 3721 02:43:56,090 --> 02:43:56,858 HELPFUL TO EVERYBODY INVOLVED. 3722 02:43:56,858 --> 02:44:02,330 SO WHAT ABOUT THE ? 3723 02:44:02,330 --> 02:44:04,766 THE FUTURE IS DIVERSIFYING THE 3724 02:44:04,766 --> 02:44:06,301 RESEARCH COMMUNITIES TO AREAS OF 3725 02:44:06,301 --> 02:44:09,771 INTEREST IN TERM OF DATA 3726 02:44:09,771 --> 02:44:11,306 MODALITY OR RESEARCH QUESTION. 3727 02:44:11,306 --> 02:44:14,042 THOUGH YOU MIGHT HAVE ONE BIG 3728 02:44:14,042 --> 02:44:17,078 POOL OF DATA WE CUT IT INTO BITS 3729 02:44:17,078 --> 02:44:20,748 TO MAKE IT MORE ACCESSIBLE AND 3730 02:44:20,748 --> 02:44:23,051 COMMUNITIES HAVING AN IDENTITY 3731 02:44:23,051 --> 02:44:25,486 AND CREATE SPECIALISMS. 3732 02:44:25,486 --> 02:44:28,756 AND ANOTHER FUTURE WE'RE WORKING 3733 02:44:28,756 --> 02:44:33,094 ON IS METADATA AND DATA LED 3734 02:44:33,094 --> 02:44:33,394 FEDERATION. 3735 02:44:33,394 --> 02:44:36,097 THE IDEAL IS YOU HAVE MANY 3736 02:44:36,097 --> 02:44:39,534 PLATFORMS BUT THEY HAVE A 3737 02:44:39,534 --> 02:44:42,937 SIBLING RELATIONSHIP IN TERMS OF 3738 02:44:42,937 --> 02:44:43,338 DATA ACCESS. 3739 02:44:43,338 --> 02:44:44,772 IF YOU LOOK TO THE RIGHT YOU 3740 02:44:44,772 --> 02:44:48,576 HAVE TO HAVE EFFECTIVELY A 3741 02:44:48,576 --> 02:44:51,412 SINGLE DATA PLATFORM TO AGREE A 3742 02:44:51,412 --> 02:44:52,347 SUBMISSION LAYER PROCESS. 3743 02:44:52,347 --> 02:44:54,582 ONLY THEN CAN THEY ACT AS 3744 02:44:54,582 --> 02:45:00,755 SIBLINGS AS EQUALS IN THE DATA 3745 02:45:00,755 --> 02:45:04,158 SHARING. 3746 02:45:04,158 --> 02:45:06,527 WE HAVE A SOLUTION BUT REQUIRES 3747 02:45:06,527 --> 02:45:07,395 TRUST BEING DEVELOPED ACROSS 3748 02:45:07,395 --> 02:45:08,563 DATA PLATFORMS. 3749 02:45:08,563 --> 02:45:14,702 ONE WAY OF DEVELOPING THIS TRUST 3750 02:45:14,702 --> 02:45:21,576 AND THIS IS PARTICULARLY HAVE 3751 02:45:21,576 --> 02:45:24,045 GOVERNANCE NEUTRAL SECURE 3752 02:45:24,045 --> 02:45:26,748 ENVIRONMENTS. 3753 02:45:26,748 --> 02:45:27,849 ONE PLATFORM CAN PROVIDE THE 3754 02:45:27,849 --> 02:45:32,286 INFRASTRUCTURE BUT BASICALLY 3755 02:45:32,286 --> 02:45:35,890 LOOKING AT THE PLATFORMS AN AND 3756 02:45:35,890 --> 02:45:39,494 IT'S ERASED AND THERE'S NO 3757 02:45:39,494 --> 02:45:44,532 LEGACY IN TERMS OF GOVERNANCE. 3758 02:45:44,532 --> 02:45:44,665 . 3759 02:45:44,665 --> 02:45:45,566 WE TRIED TO BE USER FACING. 3760 02:45:45,566 --> 02:45:48,770 THE QUESTIONS ARE TOUGH AND NEED 3761 02:45:48,770 --> 02:45:49,737 TO BE PERSISTENT. 3762 02:45:49,737 --> 02:45:52,774 THOUGH WE LOOK FOR SPECIFICS WE 3763 02:45:52,774 --> 02:45:55,977 DEVELOPED GENERIC SOLUTIONS, 3764 02:45:55,977 --> 02:45:58,780 STANDARDIZATION OF STREAMLINING 3765 02:45:58,780 --> 02:46:00,515 AND INCREMENTAL IMPROVEMENT AND 3766 02:46:00,515 --> 02:46:01,783 THINK STRATEGICALLY. 3767 02:46:01,783 --> 02:46:03,284 THERE'S A BROADER FOCUS HERE. 3768 02:46:03,284 --> 02:46:07,355 AND I JUST LEAVE YOU WITH THE 3769 02:46:07,355 --> 02:46:10,191 COLLABORATION RAPID DATA ACCESS, 3770 02:46:10,191 --> 02:46:11,692 TRUSTWORTHINESS AND USER-LED 3771 02:46:11,692 --> 02:46:12,627 DEVELOPMENT AND OPTIMIZING 3772 02:46:12,627 --> 02:46:15,530 INFORMATION BECAUSE IT'S NOT 3773 02:46:15,530 --> 02:46:24,205 ABOUT THE TECHNOLOGY IT'S ABOUT 3774 02:46:24,205 --> 02:46:25,106 THE PEOPLE. 3775 02:46:25,106 --> 02:46:27,308 THANK YOU. 3776 02:46:27,308 --> 02:46:31,079 >> NEXT IS DR. ANNA GREENWOOD 3777 02:46:31,079 --> 02:46:31,946 FROM SAGE BIO NETWORKS. 3778 02:46:31,946 --> 02:46:42,123 THANK YOU. 3779 02:46:54,335 --> 02:46:56,804 >> I WANT TO TALK ABOUT A NODE 3780 02:46:56,804 --> 02:47:00,975 OF REPOSITORIES. 3781 02:47:00,975 --> 02:47:03,077 THE PREVIOUS ALZHEIMER'S SUMMITS 3782 02:47:03,077 --> 02:47:04,412 EMPHASIZED A NEED FOR OPEN 3783 02:47:04,412 --> 02:47:04,912 SCIENCE. 3784 02:47:04,912 --> 02:47:07,482 THIS HAS BEEN A RECURRING THEME 3785 02:47:07,482 --> 02:47:11,919 WE HEARD STARTING IN 2012 AND 3786 02:47:11,919 --> 02:47:12,753 THROUGH THE THREE DAYS WE'VE 3787 02:47:12,753 --> 02:47:19,093 BEEN MEETING SO FAR. 3788 02:47:19,093 --> 02:47:20,528 THE MORE WE CAN MAKE SCIENCE 3789 02:47:20,528 --> 02:47:22,864 ACCESSIBLE AND REPEATABLE AND 3790 02:47:22,864 --> 02:47:26,200 TRANSPARENT WE CAN ACCELERATE 3791 02:47:26,200 --> 02:47:29,537 DISCOVERIES AND BRIDGE THE 3792 02:47:29,537 --> 02:47:30,138 TRANSLATIONAL GAP. 3793 02:47:30,138 --> 02:47:32,640 DATA SHARING IS ONE OF THE MANY 3794 02:47:32,640 --> 02:47:33,808 TOOLS IN THE TOOL KIT OF OPEN 3795 02:47:33,808 --> 02:47:36,844 SCIENCE BUT IT'S REALLY NOT EASY 3796 02:47:36,844 --> 02:47:44,085 TO SHARE DATA. 3797 02:47:44,085 --> 02:47:46,554 THIS IS ANALYSIS FROM YEARS AGO 3798 02:47:46,554 --> 02:47:48,356 AND IN MANUSCRIPTS WHERE PEOPLE 3799 02:47:48,356 --> 02:47:49,824 SAID THEY'D SHARE DATA ON 3800 02:47:49,824 --> 02:47:52,293 REQUEST, LESS THAN 10% OF THOSE 3801 02:47:52,293 --> 02:47:53,427 AUTHORS ACTUALLY FOLLOWED 3802 02:47:53,427 --> 02:47:54,428 THROUGH WITH THAT REQUEST. 3803 02:47:54,428 --> 02:48:03,004 IT'S REALLY DIFFICULT TO SHARE 3804 02:48:03,004 --> 02:48:03,204 DATA. 3805 02:48:03,204 --> 02:48:05,673 THE REASON IS MULTIFACETS BUT WE 3806 02:48:05,673 --> 02:48:09,277 NEED A VARIETY OF INCENTIVES AND 3807 02:48:09,277 --> 02:48:10,178 PROCESSES. 3808 02:48:10,178 --> 02:48:12,046 GRANTS AND DEDICATED FUNDING TO 3809 02:48:12,046 --> 02:48:16,217 SUPPORT THE CURATION AND SHARING 3810 02:48:16,217 --> 02:48:19,220 OF DATA IS REQUIRED THEN 3811 02:48:19,220 --> 02:48:20,755 INCENTIVES WHETHER THOSE BE 3812 02:48:20,755 --> 02:48:22,056 COMPETITION LEADER BOARDS TO GET 3813 02:48:22,056 --> 02:48:23,191 PEOPLE EXCITED ABOUT SHARING 3814 02:48:23,191 --> 02:48:25,626 DATA OR WHAT WE FIND AS THE 3815 02:48:25,626 --> 02:48:26,961 COORDINATING CENTER TO BE THE 3816 02:48:26,961 --> 02:48:29,130 MOST EFFECTIVE IS A HEAVY STICK 3817 02:48:29,130 --> 02:48:32,767 TO MAKE SURE THAT PEOPLE REALLY 3818 02:48:32,767 --> 02:48:35,102 ARE SHARING THE DATA REQUIRED BY 3819 02:48:35,102 --> 02:48:40,675 THEIR FUNDING SOURCES. 3820 02:48:40,675 --> 02:48:41,976 PEOPLE AND INFRASTRUCTURE ARE 3821 02:48:41,976 --> 02:48:44,745 ANOTHER CORE COMPONENT OF 3822 02:48:44,745 --> 02:48:55,156 SUPPORTING DATA SHARING. 3823 02:48:57,625 --> 02:49:01,329 AND LOOK AT DATA CENTERS FOR 3824 02:49:01,329 --> 02:49:02,964 EXCEPTIONAL LONGEVITY. 3825 02:49:02,964 --> 02:49:04,432 YOU HEARD ABOUT THE EXCEPTIONAL 3826 02:49:04,432 --> 02:49:08,769 LONGEVITY STUDIES ON THE FIRST 3827 02:49:08,769 --> 02:49:10,738 DAY OF THE CONFERENCE. 3828 02:49:10,738 --> 02:49:13,441 TOGETHER THESE CONSORTIA ARE 3829 02:49:13,441 --> 02:49:16,844 GENERATING A RICH RESOURCE OF 3830 02:49:16,844 --> 02:49:19,046 MULTI-OMIC PROFILING DATA ON 3831 02:49:19,046 --> 02:49:20,748 LONGITUDINAL COHORTS AND 3832 02:49:20,748 --> 02:49:24,752 CROSS-SECTIONAL COHORTS AND ALSO 3833 02:49:24,752 --> 02:49:30,491 ANIMAL MODELS AND EARLY 3834 02:49:30,491 --> 02:49:34,895 TRANSLATIONAL STUDIES WE 3835 02:49:34,895 --> 02:49:35,863 DEVELOPED AN INTERCONNECTED 3836 02:49:35,863 --> 02:49:38,633 SUITE OF PLATFORMS TO HELP SHARE 3837 02:49:38,633 --> 02:49:39,700 THE DATA FROM THESE PROGRAMS. 3838 02:49:39,700 --> 02:49:45,573 I'LL TELL YOU ABOUT THESE TODAY. 3839 02:49:45,573 --> 02:49:47,875 AT THE HEART ARE TWO DATA 3840 02:49:47,875 --> 02:49:50,878 PORTALS ENABLING ACCESS TO 3841 02:49:50,878 --> 02:49:54,248 LONGEVITY DATA RELIED ON A 3842 02:49:54,248 --> 02:49:54,815 SHARED INFRASTRUCTURE OUR 3843 02:49:54,815 --> 02:49:56,751 SYNAPSE PLATFORM. 3844 02:49:56,751 --> 02:49:59,153 THE ELITE PORTAL AND EXCEPTIONAL 3845 02:49:59,153 --> 02:50:00,821 RESOURCES PORTAL AND AD 3846 02:50:00,821 --> 02:50:02,890 KNOWLEDGE PORTAL. 3847 02:50:02,890 --> 02:50:04,158 THE ELITE PORTAL IS CURRENTLY IN 3848 02:50:04,158 --> 02:50:05,960 A BETA VERSION. 3849 02:50:05,960 --> 02:50:12,933 IT'S PUBLICALLY ACCESSIBLE. 3850 02:50:12,933 --> 02:50:15,970 AND THE OFFICIAL LAUNCH WILL 3851 02:50:15,970 --> 02:50:20,241 HAPPEN THIS FALL. 3852 02:50:20,241 --> 02:50:24,478 IT HAS DATA FROM CENTENARIANS 3853 02:50:24,478 --> 02:50:26,314 AND COGNITIVE TRAITS AND 3854 02:50:26,314 --> 02:50:30,918 MULTI-OMICS DATA FROM HUMAN AND 3855 02:50:30,918 --> 02:50:31,819 ANIMAL MODEL SYSTEMS. 3856 02:50:31,819 --> 02:50:34,188 AND THE AD KNOWLEDGE PORTAL HAS 3857 02:50:34,188 --> 02:50:35,723 BEEN AROUND A LOT LONGER. 3858 02:50:35,723 --> 02:50:43,531 OVER SO YEARS OLD NOW. 3859 02:50:43,531 --> 02:50:45,566 AND HAVE DATA FROM DATA TYPES 3860 02:50:45,566 --> 02:50:48,436 AND HUMAN SUBJECTS FROM OVER 3861 02:50:48,436 --> 02:50:50,338 30,000 HUMAN SPECIMENS AND THIS 3862 02:50:50,338 --> 02:50:52,340 HAS BEEN WIDELY USED. 3863 02:50:52,340 --> 02:50:55,209 JUST SINCE 2022 WE HAD 4800 3864 02:50:55,209 --> 02:50:57,578 UNIQUE USERS WHO HAVE DOWNLOADED 3865 02:50:57,578 --> 02:51:03,050 OVER 3. 8 MILLION FILES. 3866 02:51:03,050 --> 02:51:06,620 AND THIS IS REALLY A RICH SET OF 3867 02:51:06,620 --> 02:51:06,821 DATA. 3868 02:51:06,821 --> 02:51:08,756 IT'S QUITE DIVERSE REFLECTING 3869 02:51:08,756 --> 02:51:14,061 THE DIVERSITY OF PROGRAMS THAT 3870 02:51:14,061 --> 02:51:15,730 IT'S SHARING DATA FROM AND HUMAN 3871 02:51:15,730 --> 02:51:20,768 AND MODEL SYSTEM DATA. 3872 02:51:20,768 --> 02:51:24,872 A WIDE DIVERSITY OF DATA TYPES 3873 02:51:24,872 --> 02:51:27,775 AND TRANSCRIPTOMIC DATA AND 3874 02:51:27,775 --> 02:51:29,310 PROTEOMICS AND METABOLOMICS AND 3875 02:51:29,310 --> 02:51:31,312 MANY STUDIES YOU HEARD ABOUT 3876 02:51:31,312 --> 02:51:33,347 OVER THE PAST FEW DAYS YOU CAN 3877 02:51:33,347 --> 02:51:36,817 FIND THE DATA IN THE AD 3878 02:51:36,817 --> 02:51:38,152 KNOWLEDGE PORTAL. 3879 02:51:38,152 --> 02:51:40,755 A LARGE FOCUS IS MULTI-OMIC DATA 3880 02:51:40,755 --> 02:51:42,056 FROM HUMANS. 3881 02:51:42,056 --> 02:51:46,127 FROM AN INDIVIDUAL POSTMORTEM 3882 02:51:46,127 --> 02:51:47,261 BRAIN THERE'S RICH MULTI-LAYERED 3883 02:51:47,261 --> 02:51:48,863 DATA FROM THE SAME SUBJECTS. 3884 02:51:48,863 --> 02:51:54,301 YOU CAN GET GENETIC DATA, 3885 02:51:54,301 --> 02:52:00,307 EPIGENETIC DATA, TRANSCRIPTOMICS 3886 02:52:00,307 --> 02:52:03,344 FROM THE SAME INDIVIDUAL WHY 3887 02:52:03,344 --> 02:52:04,412 ALLOWSES FOR A RICH DISSECTION 3888 02:52:04,412 --> 02:52:06,280 OF THE UNDER PINNING OF 3889 02:52:06,280 --> 02:52:06,981 ALZHEIMER'S DISEASE. 3890 02:52:06,981 --> 02:52:12,052 WE WORKED HARD TO MAKE THE 3891 02:52:12,052 --> 02:52:16,123 PORTAL PRETTY EASY FOR USERS TO 3892 02:52:16,123 --> 02:52:16,624 FIND RESOURCES. 3893 02:52:16,624 --> 02:52:18,993 THERE'S A SIMPLE PROCESS TO 3894 02:52:18,993 --> 02:52:22,963 EXPLORE THE DATA THAT'S 3895 02:52:22,963 --> 02:52:24,765 AVAILABLE AND THEN BROWSING AND 3896 02:52:24,765 --> 02:52:26,333 LOCATING THE DATA OF INTEREST. 3897 02:52:26,333 --> 02:52:28,335 THEN WE ALLOW DATA TO BE 3898 02:52:28,335 --> 02:52:31,772 ACCESSED IN MULTIPLE WAYS. 3899 02:52:31,772 --> 02:52:33,541 WE PERMIT USERS TO DOWNLOAD THE 3900 02:52:33,541 --> 02:52:35,443 DATA ONCE THEY'VE GONE THROUGH 3901 02:52:35,443 --> 02:52:37,044 THE CONTROLLED ACCESS REQUEST 3902 02:52:37,044 --> 02:52:39,146 PROCESS THEY CAN DOWNLOAD DATA 3903 02:52:39,146 --> 02:52:42,149 OR OUT IT ON THEIR OWN CLOUD 3904 02:52:42,149 --> 02:52:45,453 SYSTEMS BUT WE'RE WORKING WITH 3905 02:52:45,453 --> 02:52:50,591 EXISTING BIO INFORMATICS 3906 02:52:50,591 --> 02:52:54,295 PLATFORMS TO BUILD BRIDGES WHERE 3907 02:52:54,295 --> 02:52:56,530 THE DATA IN THE AD KNOWLEDGE 3908 02:52:56,530 --> 02:53:00,734 PORTAL CAN BE ANALYZED IN THESE 3909 02:53:00,734 --> 02:53:03,537 POWERFUL PLATFORMS. 3910 02:53:03,537 --> 02:53:04,505 ONE OF THE THINGS WE WORK HARD 3911 02:53:04,505 --> 02:53:05,873 TO DO IS NOT JUST GET THE DATA 3912 02:53:05,873 --> 02:53:08,742 OUT THERE AND HAVE THE PORTAL, 3913 02:53:08,742 --> 02:53:11,345 BUT WE FOUND THAT PROVIDING USER 3914 02:53:11,345 --> 02:53:12,980 SUPPORT HELPS FACILITATE DATA 3915 02:53:12,980 --> 02:53:13,180 REUSE. 3916 02:53:13,180 --> 02:53:15,749 WE HAVE A DISCUSSION FORUM WHERE 3917 02:53:15,749 --> 02:53:18,586 PEOPLE CAN ASK ANY QUESTION 3918 02:53:18,586 --> 02:53:20,754 ABOUT THE DATA AND SOMETIMES 3919 02:53:20,754 --> 02:53:26,193 USERS WILL EVEN ANSWER OTHER'S 3920 02:53:26,193 --> 02:53:27,127 QUESTIONS AND HAVE EXAMPLES HOW 3921 02:53:27,127 --> 02:53:29,930 TO WORK WITH THE DATA. 3922 02:53:29,930 --> 02:53:32,766 WE HAVE A NEWS LETTER AND DATA 3923 02:53:32,766 --> 02:53:33,601 RELEASE NOTES SAYING WHENEVER 3924 02:53:33,601 --> 02:53:35,803 DATA HAS BEEN UPDATED AND THEN 3925 02:53:35,803 --> 02:53:40,508 WE HAVE HANDS ON WORKSHOPS. 3926 02:53:40,508 --> 02:53:43,244 WE HAD ONE AT THE ALZHEIMER'S 3927 02:53:43,244 --> 02:53:43,844 ASSOCIATION CONFERENCE THIS 3928 02:53:43,844 --> 02:53:45,479 SUMMER AND HAVE THEM THROUGHOUT 3929 02:53:45,479 --> 02:53:46,814 THE YEAR VIRTUALLY OR IN PERSON 3930 02:53:46,814 --> 02:53:48,749 TO GET PEOPLE FAMILIAR WITH HOW 3931 02:53:48,749 --> 02:53:53,454 TO WORK WITH THE DATA. 3932 02:53:53,454 --> 02:53:57,892 AND THESE EFFORTS HAVE BORNE 3933 02:53:57,892 --> 02:53:58,092 FRUIT. 3934 02:53:58,092 --> 02:54:00,394 WITH FIND MOST THE DATA REUSE 3935 02:54:00,394 --> 02:54:03,430 HAS DEMONSTRATED BY PUBLICATIONS 3936 02:54:03,430 --> 02:54:04,765 THAT REFERENCE THE AD KNOWLEDGE 3937 02:54:04,765 --> 02:54:06,867 PORTAL COMES FROM SECONDARY DATA 3938 02:54:06,867 --> 02:54:07,268 USE. 3939 02:54:07,268 --> 02:54:08,836 THOUGH DATA CONTRIBUTORS ARE 3940 02:54:08,836 --> 02:54:12,740 FAMILIAR WITH THE DATA AND 3941 02:54:12,740 --> 02:54:20,915 PUBLISH AS WELL THE MAJORITY 3942 02:54:20,915 --> 02:54:21,448 REPRESENT PEOPLE IN THE 3943 02:54:21,448 --> 02:54:24,685 COMMUNITY AS WE SEE AS A TRUE 3944 02:54:24,685 --> 02:54:26,987 TESTAMENT TO THE POWER OF OPEN 3945 02:54:26,987 --> 02:54:27,221 SCIENCE. 3946 02:54:27,221 --> 02:54:31,825 WE'RE CONTINUING TO IMPROVE 3947 02:54:31,825 --> 02:54:32,760 THESE PORTALS AND 3948 02:54:32,760 --> 02:54:33,127 INFRASTRUCTURE. 3949 02:54:33,127 --> 02:54:34,662 SOME OF THE NEW IMPROVEMENTS 3950 02:54:34,662 --> 02:54:38,098 COMING IN THE NEXT PHASE OF OUR 3951 02:54:38,098 --> 02:54:38,933 COORDINATING CENTER GRANTS 3952 02:54:38,933 --> 02:54:42,002 INCLUDE THE ABILITY TO SEARCH 3953 02:54:42,002 --> 02:54:44,538 FOR DATA BY PROPERTIES OF AN 3954 02:54:44,538 --> 02:54:46,440 INDIVIDUAL BY CHARACTERISTICS OF 3955 02:54:46,440 --> 02:54:48,742 AN INDIVIDUAL AND IMPROVED 3956 02:54:48,742 --> 02:54:49,577 NAVIGATION WE'RE CONTINUALLY 3957 02:54:49,577 --> 02:54:55,516 TRYING TO MAKE THIS EASIER FOR 3958 02:54:55,516 --> 02:54:56,183 USERS. 3959 02:54:56,183 --> 02:54:58,852 AND WE ARE CONTINUING TO EXPAND 3960 02:54:58,852 --> 02:55:01,622 THE DATA AS NEW TECHNOLOGIES AND 3961 02:55:01,622 --> 02:55:04,458 DATA ARE MADE AVAILABLE. 3962 02:55:04,458 --> 02:55:08,629 A BIG FOCUS ON IMPROVING 3963 02:55:08,629 --> 02:55:10,464 DIVERSITY IN OUR SAMPLES. 3964 02:55:10,464 --> 02:55:14,702 AND IN MY LAST COUPLE MINUTES I 3965 02:55:14,702 --> 02:55:16,837 WANTED TO MENTION A 3966 02:55:16,837 --> 02:55:19,239 COMPLEMENTARY PLATFORM CALLED 3967 02:55:19,239 --> 02:55:26,614 AGORA TO HELP DEMOCRATIZE THE 3968 02:55:26,614 --> 02:55:28,082 RESOURCES TO A BROADER 3969 02:55:28,082 --> 02:55:29,850 COMMUNITY. 3970 02:55:29,850 --> 02:55:32,119 IT'S AN DATA EXPLORER WHERE WE 3971 02:55:32,119 --> 02:55:38,926 HAVE TAKEN THE DATA FROM THE AD 3972 02:55:38,926 --> 02:55:40,961 KNOWLEDGE PORTAL AND REANALYZED 3973 02:55:40,961 --> 02:55:43,197 THAT AND PROCESSED IT AND 3974 02:55:43,197 --> 02:55:45,499 SUMMARIZED IT IN A CURATED WAY. 3975 02:55:45,499 --> 02:55:51,038 YOU CAN GO TO AGORA AND LOOK AT 3976 02:55:51,038 --> 02:55:54,341 ANY GENE OF INTEREST AND SEE HOW 3977 02:55:54,341 --> 02:55:56,777 IT'S ASSOCIATED WITH ALZHEIMER'S 3978 02:55:56,777 --> 02:56:03,217 DISEASE AND COMPARE ACROSS THE 3979 02:56:03,217 --> 02:56:05,552 GENES USING THE GENE COMPARISON 3980 02:56:05,552 --> 02:56:05,919 TOOL. 3981 02:56:05,919 --> 02:56:08,022 ONCE YOU FIND A GENE OF INTEREST 3982 02:56:08,022 --> 02:56:10,324 WE HAVE A RICH SET TO HELP YOU 3983 02:56:10,324 --> 02:56:12,726 UNDERSTAND HOW THE GENE MAY BE 3984 02:56:12,726 --> 02:56:13,327 INTERACTING WITH ALZHEIMER'S 3985 02:56:13,327 --> 02:56:23,470 DISEASE. 3986 02:56:24,905 --> 02:56:25,939 AND INFORMATION HOW TRACTABLE 3987 02:56:25,939 --> 02:56:28,742 THE INFORMATION MIGHT BE. 3988 02:56:28,742 --> 02:56:31,145 AND WITH THAT I WANTED TO 3989 02:56:31,145 --> 02:56:32,312 QUICKLY ACKNOWLEDGE THE LARGE 3990 02:56:32,312 --> 02:56:34,148 TEAM OF PEOPLE AT SAGE WHO 3991 02:56:34,148 --> 02:56:35,716 CONTRIBUTED TO THE WORK AND 3992 02:56:35,716 --> 02:56:40,754 PARTICULARLY I WANTED TO THANK 3993 02:56:40,754 --> 02:56:44,024 ERICA, LAURIE AND SUSANA FOR HER 3994 02:56:44,024 --> 02:56:50,531 AMAZING VISION AND LEADERSHIP. 3995 02:56:50,531 --> 02:56:56,737 >> THE NEXT SPEAKER IS MY 3996 02:56:56,737 --> 02:57:00,607 CO-CHAIR GUSTAVO 3997 02:57:00,607 --> 02:57:02,810 JIMENEZ-MAGGIORA FROM UNIVERSITY 3998 02:57:02,810 --> 02:57:03,310 OF SOUTHERN CALIFORNIA. 3999 02:57:03,310 --> 02:57:13,554 >> THANK YOU. 4000 02:57:13,887 --> 02:57:16,924 >> I WANTED TO START BY THANKING 4001 02:57:16,924 --> 02:57:19,226 THE SUMMIT ORGANIZERS FOR 4002 02:57:19,226 --> 02:57:21,495 INVITING ME TO PRESENT ON ACTC 4003 02:57:21,495 --> 02:57:23,664 AND OUR APPROACH TO CLINICAL 4004 02:57:23,664 --> 02:57:24,198 TRIALS DATA AND RESOURCE 4005 02:57:24,198 --> 02:57:30,370 SHARING. 4006 02:57:30,370 --> 02:57:31,772 IT'S THE ALZHEIMER'S CLINICAL 4007 02:57:31,772 --> 02:57:33,574 TRIALS CONSORTIUM. 4008 02:57:33,574 --> 02:57:37,811 IT'S AN NIA PROGRAM THAT IT LED 4009 02:57:37,811 --> 02:57:42,483 JOINTLY BY THE UNIVERSITY OF 4010 02:57:42,483 --> 02:57:47,488 SOUTHERN CALIFORNIA AND HARVARD 4011 02:57:47,488 --> 02:57:51,592 AND THE MAYO CLINIC TO ESTABLISH 4012 02:57:51,592 --> 02:57:56,130 A STANDING INFRASTRUCTURE THAT 4013 02:57:56,130 --> 02:57:58,799 IS COMPOSED OF 35 SITES AS WELL 4014 02:57:58,799 --> 02:57:59,933 AS EXPERT-LED UNITS AND 4015 02:57:59,933 --> 02:58:05,339 COMMITTEES. 4016 02:58:05,339 --> 02:58:07,007 ACTC HAS A LONG STANDING 4017 02:58:07,007 --> 02:58:08,742 COMMITMENT TO OPEN SCIENCE 4018 02:58:08,742 --> 02:58:10,177 ALIGNED WITH NIA EXPECTATIONS AS 4019 02:58:10,177 --> 02:58:13,680 WELL AS WITH THE PRINCIPLES OF 4020 02:58:13,680 --> 02:58:16,750 FAIR DATA AND COLLABORATION FOR 4021 02:58:16,750 --> 02:58:18,352 ALZHEIMER'S PREVENTION. 4022 02:58:18,352 --> 02:58:24,591 TO MEET THIS COMMITMENT WE 4023 02:58:24,591 --> 02:58:26,293 SUPPORT BROAD AND TIMELY TRIAL 4024 02:58:26,293 --> 02:58:34,635 DATA DESIGN TO PROTECT INTEGRITY 4025 02:58:34,635 --> 02:58:40,574 AND PRIVACY AND HAS ANONYMIZED 4026 02:58:40,574 --> 02:58:42,476 BIO SPECIMEN AND ANALYSIS, 4027 02:58:42,476 --> 02:58:44,745 INSTRUMENTS AND EXPERTRY IN 4028 02:58:44,745 --> 02:58:49,016 TRIAL DESIGN AND DOCUMENTS. 4029 02:58:49,016 --> 02:58:52,319 OUR GOAL IS TO SHARE DATA AT TWO 4030 02:58:52,319 --> 02:58:53,854 CRITICAL TIME POINTS IN THE 4031 02:58:53,854 --> 02:58:55,088 STUDY LIFE CYCLE. 4032 02:58:55,088 --> 02:58:56,757 THE FIRST OF WHICH IS ONE YEAR 4033 02:58:56,757 --> 02:58:58,859 AFTER THE COMPLETION OF 4034 02:58:58,859 --> 02:59:00,761 ENROLLMENT WHERE WE SHARE ALL 4035 02:59:00,761 --> 02:59:04,698 THE SCREENING DATA FOR A TRIAL. 4036 02:59:04,698 --> 02:59:06,333 AND THE SECOND TIME POINT IS ONE 4037 02:59:06,333 --> 02:59:11,972 YEAR AFTER THE REPORTING OF THE 4038 02:59:11,972 --> 02:59:14,174 TRIAL RESULTS WHERE WE SHARE THE 4039 02:59:14,174 --> 02:59:14,741 DATA SET. 4040 02:59:14,741 --> 02:59:16,743 TO FACILITATE OUR APPROACH I'D 4041 02:59:16,743 --> 02:59:18,979 LIKE TO QUICKLY SHARE CASE STUDY 4042 02:59:18,979 --> 02:59:20,747 OF OUR EFFORT TO SHARE THE A4 4043 02:59:20,747 --> 02:59:23,650 TRIAL DATA. 4044 02:59:23,650 --> 02:59:27,588 IT WAS A PHASE III RANDOMIZED 4045 02:59:27,588 --> 02:59:28,255 CLINICAL TRIAL LOOKING AT 4046 02:59:28,255 --> 02:59:38,799 EFFICACY AND SAFETY OF THE USE 4047 02:59:39,666 --> 02:59:45,272 OF SOLEANEZEW ZUMAB AND SCREENED 4048 02:59:45,272 --> 02:59:48,742 PARTICIPANTS BETWEEN THE AGES OF 4049 02:59:48,742 --> 02:59:59,286 65 AND 85 CLINICALLY NORMAL OF 4050 03:00:11,098 --> 03:00:12,065 THE PARTICIPANTS WHO FAILED TO 4051 03:00:12,065 --> 03:00:14,301 BE ENROLLED IN THE MAIN STUDY 4052 03:00:14,301 --> 03:00:18,805 WERE ENROLLED INTO AN 4053 03:00:18,805 --> 03:00:20,741 OBSERVATIONAL COHORT AND WERE 4054 03:00:20,741 --> 03:00:23,677 FOLLOWED UP FOR THE SAME PERIOD 4055 03:00:23,677 --> 03:00:25,512 USING THE SAME PROTOCOL. 4056 03:00:25,512 --> 03:00:28,048 IF LEWD LIKE MORE INFORMATION 4057 03:00:28,048 --> 03:00:33,620 ABOUT THE TRIALS, I ENCOURAGE 4058 03:00:33,620 --> 03:00:36,456 YOU TO VISIT CLINICAL TRIALS DOT 4059 03:00:36,456 --> 03:00:37,090 GOV. 4060 03:00:37,090 --> 03:00:40,260 WE SHARED THE SCREENING DATA SET 4061 03:00:40,260 --> 03:00:44,665 FOR A4 AT THE END OF 2018. 4062 03:00:44,665 --> 03:00:48,669 AND THE FINAL DATA SET WHICH 4063 03:00:48,669 --> 03:00:50,504 INCLUDES PLACEBO AND TREATMENT 4064 03:00:50,504 --> 03:00:52,739 ARMS DATA WAS SHARED RECENTLY A 4065 03:00:52,739 --> 03:00:55,075 FEW WEEKS AGO. 4066 03:00:55,075 --> 03:00:59,546 THIS DATA SET INCLUDES CLINICAL, 4067 03:00:59,546 --> 03:01:03,717 COGNITIVE AND LAB DATA AS WELL 4068 03:01:03,717 --> 03:01:05,986 AS BIOMARKER DATA THAT INCLUDE 4069 03:01:05,986 --> 03:01:08,522 FLUID AS WELL AS IMAGING 4070 03:01:08,522 --> 03:01:09,589 BIOMARKER DATA. 4071 03:01:09,589 --> 03:01:12,426 AN ENORMOUS AMOUNT OF NEURAL 4072 03:01:12,426 --> 03:01:15,262 IMAGING DATA ACROSS MODALITIES 4073 03:01:15,262 --> 03:01:18,765 AND GENETIC DATA. 4074 03:01:18,765 --> 03:01:20,100 I'D LIKE TO SHARE RESULT OF THE 4075 03:01:20,100 --> 03:01:30,644 EFFORTS WITH YOU AT THIS POINT. 4076 03:01:30,644 --> 03:01:34,348 FOR SCREENING DATA THE DATA WAS 4077 03:01:34,348 --> 03:01:36,216 SHARED USING LONI AND THE TWO 4078 03:01:36,216 --> 03:01:39,252 PANELS ON THE RIGHT-HAND SIDE OF 4079 03:01:39,252 --> 03:01:41,621 THE SLIDE QUANTIFY THE NUMBER OF 4080 03:01:41,621 --> 03:01:43,590 APPROVED REQUESTS THAT WE HAVE 4081 03:01:43,590 --> 03:01:46,960 RECEIVED OVER THE PAST FIVE 4082 03:01:46,960 --> 03:01:47,461 YEARS. 4083 03:01:47,461 --> 03:01:50,230 MORE THAN 1500 REQUESTS HAVE 4084 03:01:50,230 --> 03:01:56,069 BEEN APPROVED BY INVESTIGATORS 4085 03:01:56,069 --> 03:01:58,739 FROM OVER 60 COUNTRIES AND THEY 4086 03:01:58,739 --> 03:02:01,842 DOWNLOADED IMAGING DATA AND 4087 03:02:01,842 --> 03:02:04,211 ULTIMATELY A LITTLE BIT MORE 4088 03:02:04,211 --> 03:02:14,988 THAN 2,000 AL ALOE ALLO QUATS 4089 03:02:14,988 --> 03:02:19,292 HAVE BEEN SHARED AND CLOSE TO 70 4090 03:02:19,292 --> 03:02:24,398 PEER-REVIEWED PUBLICATIONS HAVE 4091 03:02:24,398 --> 03:02:31,438 REFERENCED THE SCREENING DATA 4092 03:02:31,438 --> 03:02:33,273 AND WHAT WE LEARNED WAS 4093 03:02:33,273 --> 03:02:35,742 SOMETHING OTHER SPEAKERS HAVE 4094 03:02:35,742 --> 03:02:37,144 MENTIONED IS THE DATA 4095 03:02:37,144 --> 03:02:39,146 PREPARATION PROCESS WAS 4096 03:02:39,146 --> 03:02:40,280 EXTREMELY LABOR INTENSIVE 4097 03:02:40,280 --> 03:02:42,249 ESPECIALLY BECAUSE WE WANTED TO 4098 03:02:42,249 --> 03:02:44,418 MAKE SURE WE APPLIED THE STATE 4099 03:02:44,418 --> 03:02:47,721 OF THE ART IN TERMS OF METHODS 4100 03:02:47,721 --> 03:02:55,562 TO DE-EYE -- DE-IDENTIFY AND 4101 03:02:55,562 --> 03:02:57,431 DEFACE THE DATA TYPE WE'RE 4102 03:02:57,431 --> 03:02:57,664 SHARING. 4103 03:02:57,664 --> 03:03:00,767 FAST FORWARDING FIVE YEARS WE 4104 03:03:00,767 --> 03:03:06,640 RECENTLY SHARED THE A4 FINAL 4105 03:03:06,640 --> 03:03:10,310 STUDY DATA. 4106 03:03:10,310 --> 03:03:12,012 I'M HAPPY TO REPORT WE APPROVED 4107 03:03:12,012 --> 03:03:16,216 MORE THAN 100 REQUESTS FROM 4108 03:03:16,216 --> 03:03:26,093 INVESTIGATORS FROM 15 COUNTRIES. 4109 03:03:26,093 --> 03:03:28,762 THIS INCLUDES MORE THAN 15,000 4110 03:03:28,762 --> 03:03:32,766 LONGITUDINAL MULTI-MODAL IMAGING 4111 03:03:32,766 --> 03:03:35,969 STUDIES. 4112 03:03:35,969 --> 03:03:37,804 ANOTHER THING WE LEARNED IS 4113 03:03:37,804 --> 03:03:39,906 DIFFERENT COMMUNITIES WITHIN THE 4114 03:03:39,906 --> 03:03:42,542 ALZHEIMER'S FIELD TEND TO 4115 03:03:42,542 --> 03:03:44,711 GRAVITATE TOWARDS DIFFERENT 4116 03:03:44,711 --> 03:03:44,978 PLATFORMS. 4117 03:03:44,978 --> 03:03:47,581 SO TO TRY TO MEET INVESTIGATORS 4118 03:03:47,581 --> 03:03:50,317 WHERE THEY ARE WE DECIDED TO 4119 03:03:50,317 --> 03:03:53,453 SHARE THE DATA FOR THIS ROUND ON 4120 03:03:53,453 --> 03:03:54,321 MULTIPLE PLATFORMS. 4121 03:03:54,321 --> 03:04:00,293 SO WE'VE SHARED THE DATA ON THE 4122 03:04:00,293 --> 03:04:01,728 GRIP PLATFORM WHICH IS A 4123 03:04:01,728 --> 03:04:03,630 COLLABORATION WITH OUR PARTNERS 4124 03:04:03,630 --> 03:04:06,333 AT GATES VENTURES AND SHARED THE 4125 03:04:06,333 --> 03:04:09,903 DATA ON SYNAPSE WHICH TENDS TO 4126 03:04:09,903 --> 03:04:14,407 BE FAIRLY FIM FAMILIAR TO THE 4127 03:04:14,407 --> 03:04:16,743 OMICS AND SHARING THE DATA ON 4128 03:04:16,743 --> 03:04:18,845 LONI AS WELL BECAUSE WE KNOW 4129 03:04:18,845 --> 03:04:20,213 IMAGEERS ARE ESPECIALLY 4130 03:04:20,213 --> 03:04:28,121 COMFORTABLE USING THE APPROACH. 4131 03:04:28,121 --> 03:04:30,257 AND TO SHARE THE LESSONS LEARNED 4132 03:04:30,257 --> 03:04:34,227 WE DEVELOPED A MANUSCRIPT TO TRY 4133 03:04:34,227 --> 03:04:39,633 TO DOCUMENT SOME 69 LESSONS 4134 03:04:39,633 --> 03:04:40,934 LEARNED IN THE EXPERT PART OF 4135 03:04:40,934 --> 03:04:44,738 THE SPECIAL ISSUE PUBLISHED IN 4136 03:04:44,738 --> 03:04:55,115 JPAD A FEW WEEKS AGO. 4137 03:04:56,816 --> 03:04:58,552 THERE'S PUBLICATIONS THAT 4138 03:04:58,552 --> 03:05:00,987 REFERENCED THE A4 SCREENING 4139 03:05:00,987 --> 03:05:01,321 DATA. 4140 03:05:01,321 --> 03:05:11,498 SO THIS IS AN ARTICLE THAT THAT 4141 03:05:11,498 --> 03:05:13,433 EXPLORE THE RELATIONSHIP BETWEEN 4142 03:05:13,433 --> 03:05:16,536 AD BIOMARKERS AND ANCESTRALLY 4143 03:05:16,536 --> 03:05:25,245 DIVERSE INDIVIDUALS. 4144 03:05:25,245 --> 03:05:28,748 THE INVESTIGATORS FOUND 4145 03:05:28,748 --> 03:05:30,684 NON-HISPANIC BLACK PARTICIPANTS 4146 03:05:30,684 --> 03:05:33,520 HAD LOWER MEASURES OF AMYLOID 4147 03:05:33,520 --> 03:05:35,155 RELATIVE TO NON-HISPANIC WHITE 4148 03:05:35,155 --> 03:05:38,525 PARTICIPANTS AND THIS AFFECT WAS 4149 03:05:38,525 --> 03:05:40,460 STRONGEST IN PARTICIPANTS THAT 4150 03:05:40,460 --> 03:05:42,495 WERE APOE 4 CARRIERS. 4151 03:05:42,495 --> 03:05:45,398 THE FINDINGS HAVE IMPLICATIONS 4152 03:05:45,398 --> 03:05:47,834 FOR FUTURE AD PREVENTION TRIALS 4153 03:05:47,834 --> 03:05:49,569 AND I THINK ARE ONE EXAMPLE OF 4154 03:05:49,569 --> 03:05:52,072 PRECISION MEDICINE APPROACHES 4155 03:05:52,072 --> 03:05:56,743 THAT MAY BE APPLICABLE TO 4156 03:05:56,743 --> 03:06:01,748 TRIALS. 4157 03:06:01,748 --> 03:06:03,783 TO CONCLUDE WITH NEXT STEPS IN 4158 03:06:03,783 --> 03:06:05,385 OUR TRIAL SHARING EFFORTS. 4159 03:06:05,385 --> 03:06:11,324 FIRST, WE PLAN TO CONTINUE TO 4160 03:06:11,324 --> 03:06:12,592 DEVELOP OUR TOOLS AND 4161 03:06:12,592 --> 03:06:15,629 INFRASTRUCTURE TO SUPPORT 4162 03:06:15,629 --> 03:06:18,598 PRECISE REQUEST FOR DATA 4163 03:06:18,598 --> 03:06:29,142 DOCUMENTATION ACROSS DATA TYPES 4164 03:06:29,576 --> 03:06:32,579 AND PLAN TO PARTNER TO IMPROVE 4165 03:06:32,579 --> 03:06:33,613 PRIVACY PROTECTING APPROACHES 4166 03:06:33,613 --> 03:06:36,449 FOR THE DIFFERENT TYPE OF 4167 03:06:36,449 --> 03:06:39,819 COMPLEX DATA TYPE AND ONE 4168 03:06:39,819 --> 03:06:41,154 EXAMPLE WOULD BE WORK WE'RE 4169 03:06:41,154 --> 03:06:43,890 HOPING TO DO WITH RHODA AND HER 4170 03:06:43,890 --> 03:06:45,558 GROUP TO DE-IDENTIFY A LARGE 4171 03:06:45,558 --> 03:06:51,631 COLLECTION OF AUDIO DATA WE HAVE 4172 03:06:51,631 --> 03:06:56,403 FOR THE TRIAL AND TRYING TO 4173 03:06:56,403 --> 03:07:00,740 PROVIDE AN OPEN SOURCE TOOL TO 4174 03:07:00,740 --> 03:07:02,008 SUPPORT ANALYSIS AND 4175 03:07:02,008 --> 03:07:06,313 VISUALIZATION AND AN APPROACH WE 4176 03:07:06,313 --> 03:07:09,616 USE A.I. DATA EXPLORATION TOOLS 4177 03:07:09,616 --> 03:07:12,686 VIA NATURAL LANGUAGE PROMPTS TO 4178 03:07:12,686 --> 03:07:14,754 SUPPORT MORE ACCESSIBLE 4179 03:07:14,754 --> 03:07:15,522 APPROACHES TO EXPLORING THESE 4180 03:07:15,522 --> 03:07:24,898 COMPLEX DATA. 4181 03:07:24,898 --> 03:07:26,533 WE WANT IT INTEGRATED INTO THE 4182 03:07:26,533 --> 03:07:28,735 BROADER ECO SYSTEM THROUGH THE 4183 03:07:28,735 --> 03:07:32,739 FAIR PRINCIPLES AND MAKE SURE WE 4184 03:07:32,739 --> 03:07:35,241 ARE PROMOTING SECONDARY USE OF 4185 03:07:35,241 --> 03:07:37,510 TRIAL DATA AND RESOURCE TO DRIVE 4186 03:07:37,510 --> 03:07:41,147 PRECISION MEDICINE APPROACHES TO 4187 03:07:41,147 --> 03:07:46,553 ACCELERATE THERAPEUTIC 4188 03:07:46,553 --> 03:07:46,853 DEVELOPMENT. 4189 03:07:46,853 --> 03:07:49,222 I WANT TO CONCLUDE BY 4190 03:07:49,222 --> 03:07:51,257 ACKNOWLEDGING THE PARTICIPANTS 4191 03:07:51,257 --> 03:07:56,496 AND THEIR FAMILIES AND STUDY 4192 03:07:56,496 --> 03:07:56,763 PARTNERS. 4193 03:07:56,763 --> 03:08:04,738 THANK YOU FOR YOUR ATTENTION. 4194 03:08:04,738 --> 03:08:11,945 >> THE NEXT TALK IS FROM MARIA 4195 03:08:11,945 --> 03:08:12,545 CARRILLO WITH THE ALZHEIMER'S 4196 03:08:12,545 --> 03:08:17,784 ASSOCIATION. 4197 03:08:17,784 --> 03:08:18,618 >> THANK YOU FOR THE NATIONAL 4198 03:08:18,618 --> 03:08:20,053 INSTITUTE ON AGING FOR 4199 03:08:20,053 --> 03:08:21,621 LEADERSHIP AND PLANNING OUT SO 4200 03:08:21,621 --> 03:08:23,556 MANY SUMMITS THAT HAVE LAID OUT 4201 03:08:23,556 --> 03:08:32,799 THE MILESTONES WE WORK WITH AND 4202 03:08:32,799 --> 03:08:34,768 PROGRESS WE'RE MAKING AND FOR 4203 03:08:34,768 --> 03:08:37,203 THE TALK I WANT TO THANK 4204 03:08:37,203 --> 03:08:44,744 DR. SNYDER AT THE ALZHEIMER'S 4205 03:08:44,744 --> 03:08:49,048 ASSOCIATION AND DR. EDDELMIER. 4206 03:08:49,048 --> 03:08:56,756 THEY'RE THE LEADS FOR ALZ NET. 4207 03:08:56,756 --> 03:09:00,760 YOU'D LIKE TO THANK CO-PRINCIPLE 4208 03:09:00,760 --> 03:09:01,461 INVESTIGATORS. 4209 03:09:01,461 --> 03:09:08,735 I THINK WE HEARD THROUGHOUT THE 4210 03:09:08,735 --> 03:09:12,639 THREE DAYS WE HAVE THE POTENTIAL 4211 03:09:12,639 --> 03:09:14,607 FOR PRECISION MEDICINE WE HAVE 4212 03:09:14,607 --> 03:09:16,743 BEEN SUPPORTIVE OF NOT ONLY 4213 03:09:16,743 --> 03:09:18,578 PRECISION MEDICINE BROADLY BUT 4214 03:09:18,578 --> 03:09:23,416 OF THE AMP AD PROGRAM SINCE THE 4215 03:09:23,416 --> 03:09:24,284 INCEPTION. 4216 03:09:24,284 --> 03:09:26,019 AND CONTINUE TO BE THERE'S GREAT 4217 03:09:26,019 --> 03:09:26,653 VALUE AND PROMISE STARTING TO 4218 03:09:26,653 --> 03:09:28,788 DELIVER AS YOU HEARD OVER THE 4219 03:09:28,788 --> 03:09:39,032 LAST FEW DAYS. 4220 03:09:41,835 --> 03:09:44,737 YOU HEARD ABOUT SHARING REAL 4221 03:09:44,737 --> 03:09:46,239 WORLD DATA AS MUCH AS WE CAN AND 4222 03:09:46,239 --> 03:09:47,474 HOW DO WE GATHER THE KNOWLEDGE 4223 03:09:47,474 --> 03:09:52,879 AND SHARE IT IN A WAY THAT IS 4224 03:09:52,879 --> 03:09:59,452 OPEN AND HAS THE APPROPRIATE 4225 03:09:59,452 --> 03:10:00,620 CONSENT AND MAXIMIZING FOR THE 4226 03:10:00,620 --> 03:10:01,521 PANEL THAT DRIVE HOME WHAT WE 4227 03:10:01,521 --> 03:10:11,431 NEED TO DO AND WHY. 4228 03:10:11,431 --> 03:10:13,967 WHEN WE FUND RESEARCH KNOW IT 4229 03:10:13,967 --> 03:10:15,268 IMPACTS DIAGNOSIS AND TREATMENT 4230 03:10:15,268 --> 03:10:18,738 AND LEADS TO BETTER CARE BUT 4231 03:10:18,738 --> 03:10:20,740 THAT BETTER CARE DRIVES MORE 4232 03:10:20,740 --> 03:10:22,041 RESEARCH BECAUSE IT'S A CIRCLE 4233 03:10:22,041 --> 03:10:25,378 THAT WE HAVE TO CONTINUE TO IT 4234 03:10:25,378 --> 03:10:28,648 RATE ON TO IMPROVE PRACTICE AND 4235 03:10:28,648 --> 03:10:33,419 IMPROVE QUALITY CARE AND PATIENT 4236 03:10:33,419 --> 03:10:41,427 EXPERIENCE ITSELF AND DRIVE 4237 03:10:41,427 --> 03:10:42,395 HEALTH EQUITY AND WHO SHOULD 4238 03:10:42,395 --> 03:10:45,498 TALK THEM AND SHOULDN'T AND WHY. 4239 03:10:45,498 --> 03:10:47,934 WE WANT TO DO A LOT OF THESE 4240 03:10:47,934 --> 03:10:49,602 THINGS WITH ALZ NET ON THE 4241 03:10:49,602 --> 03:10:49,869 RIGHT. 4242 03:10:49,869 --> 03:10:52,238 I WON'T BELABOR THEM BECAUSE OF 4243 03:10:52,238 --> 03:10:56,743 TIME BUT IT'S A VOLUNTARY HEALTH 4244 03:10:56,743 --> 03:11:02,315 CARE PROVIDER NETWORK. 4245 03:11:02,315 --> 03:11:04,183 THEY ENROLL THEM IN BEING 4246 03:11:04,183 --> 03:11:07,153 EVALUATED FOR TREATMENT WITH A 4247 03:11:07,153 --> 03:11:08,154 NOVEL TREATMENT APPROVED BY FDA 4248 03:11:08,154 --> 03:11:12,358 AFTER 2021. 4249 03:11:12,358 --> 03:11:15,261 THE KEY TO THE MIDDLE PORTION IS 4250 03:11:15,261 --> 03:11:16,729 EVALUATED FOR TREATMENT. 4251 03:11:16,729 --> 03:11:22,936 WE WANT TO FOLLOW THEM EVEN 4252 03:11:22,936 --> 03:11:25,438 AFTER THE EVALUATION WHETHER 4253 03:11:25,438 --> 03:11:26,439 THEY DECIDE ON TREATMENT OR NOT 4254 03:11:26,439 --> 03:11:28,775 BECAUSE SOMETIMES YOU GET MORE 4255 03:11:28,775 --> 03:11:31,477 INFORMATION WHEN YOU FOLLOW 4256 03:11:31,477 --> 03:11:33,613 THOSE WHO CHOSE OR COULD NOT BE 4257 03:11:33,613 --> 03:11:44,090 ELIGIBLE FOR THE TREATMENT. 4258 03:11:46,225 --> 03:11:48,728 HERE'S A SNAPSHOT OF THE 4259 03:11:48,728 --> 03:11:51,598 QUESTIONS WE CAN ADDRESS WITH 4260 03:11:51,598 --> 03:11:51,831 ALZ NET. 4261 03:11:51,831 --> 03:11:56,402 YOU CAN PROBABLY THINK OF 4262 03:11:56,402 --> 03:11:57,337 QUESTIONS THAT ARE BETTER ONES 4263 03:11:57,337 --> 03:12:01,407 THAN WE AND THE NETWORK WILL BE 4264 03:12:01,407 --> 03:12:03,509 AVAILABLE FOR YOU TO DOWNLOAD 4265 03:12:03,509 --> 03:12:03,810 DATA. 4266 03:12:03,810 --> 03:12:04,844 I WON'T GO THROUGH THEM BECAUSE 4267 03:12:04,844 --> 03:12:10,316 YOU CAN READ AND ACCESS THE 4268 03:12:10,316 --> 03:12:14,821 SLIDES THESE ARE QUESTIONS WE'VE 4269 03:12:14,821 --> 03:12:16,389 BEEN ASKING THE LAST THREE DAYS. 4270 03:12:16,389 --> 03:12:22,562 ALZ NET CONTINUES TO DPROE. 4271 03:12:22,562 --> 03:12:26,466 IT'S A VOLUNTARY PROVIDER 4272 03:12:26,466 --> 03:12:26,966 REGISTRY. 4273 03:12:26,966 --> 03:12:29,335 OUR LARGEST SITE IS AT INDIANA 4274 03:12:29,335 --> 03:12:32,739 UNIVERSITY. 4275 03:12:32,739 --> 03:12:35,241 THEY'LL START ENROLLING WE HAVE 4276 03:12:35,241 --> 03:12:37,510 PATIENTS ENROLLED THAT WILL BE 4277 03:12:37,510 --> 03:12:39,612 FOLLOWED EVERY SIX MONTHS WITH 4278 03:12:39,612 --> 03:12:43,549 THEIR PROVIDERS GIVING US 4279 03:12:43,549 --> 03:12:45,618 INFORMATION WE ARE PROVIDING 4280 03:12:45,618 --> 03:12:46,919 MONETARY INCENTIVE TO PROVIDERS 4281 03:12:46,919 --> 03:12:48,988 AND CLINICS TO PAY FOR THEIR 4282 03:12:48,988 --> 03:12:52,025 TIME FOR PARTICIPANTING IN ALZ 4283 03:12:52,025 --> 03:12:54,127 NET. 4284 03:12:54,127 --> 03:12:55,828 IF WITH YOU WANT MORE DETAILS 4285 03:12:55,828 --> 03:12:57,664 LOOK AT THE QR CODE OR E-MAIL 4286 03:12:57,664 --> 03:13:00,733 ANY OF US AT THE END OF THE 4287 03:13:00,733 --> 03:13:02,201 CONVERSATION. 4288 03:13:02,201 --> 03:13:03,936 THIS IS THE TYPE OF DATA WE'RE 4289 03:13:03,936 --> 03:13:04,737 COLLECTING. 4290 03:13:04,737 --> 03:13:07,040 WE TRIED OUR HARDEST TO PUT A 4291 03:13:07,040 --> 03:13:08,341 WISH LIST IN. 4292 03:13:08,341 --> 03:13:11,811 AT THE SAME TIME NOT MAKE IT SO 4293 03:13:11,811 --> 03:13:14,013 ONEROUS FOR THE CLINICIANS TO 4294 03:13:14,013 --> 03:13:16,582 NEED MORE THAN 15 MINUTES TO 4295 03:13:16,582 --> 03:13:17,183 INPUT THIS WHOEVER THEY 4296 03:13:17,183 --> 03:13:23,556 DESIGNATE IN THEIR CLINIC. 4297 03:13:23,556 --> 03:13:25,591 SO IMPORTANT TO HAVE INFORMATION 4298 03:13:25,591 --> 03:13:27,927 BUT NOT TOO MUCH WE CAN'T MAKE 4299 03:13:27,927 --> 03:13:34,667 THIS A USABLE FORMAT FOR THOSE 4300 03:13:34,667 --> 03:13:36,335 PARTICIPATING THIS IS MORE THAN 4301 03:13:36,335 --> 03:13:37,303 THE MEDICARE AND MEDICAID 4302 03:13:37,303 --> 03:13:37,770 REGISTRY USES. 4303 03:13:37,770 --> 03:13:39,272 WE ACKNOWLEDGE THAT. 4304 03:13:39,272 --> 03:13:45,211 WE DO THINK THAT REGISTRY IS 4305 03:13:45,211 --> 03:13:49,949 FAIRLY UNHELPFUL ABOUT SAFETY 4306 03:13:49,949 --> 03:13:51,751 AND OTHER EVENTS WE THINK WILL 4307 03:13:51,751 --> 03:13:52,752 BE VERY IMPORTANT. 4308 03:13:52,752 --> 03:13:55,455 WE ARE ENGAGED IN THINKING ABOUT 4309 03:13:55,455 --> 03:13:59,158 HOW WE CAN CREATE A BROADER 4310 03:13:59,158 --> 03:14:01,627 PLATFORM AND THIS WAS ACTUALLY 4311 03:14:01,627 --> 03:14:03,629 VERY WELL SPELLED OUT IN A 4312 03:14:03,629 --> 03:14:05,331 RECENT PROPOSAL WE PUT TOGETHER 4313 03:14:05,331 --> 03:14:08,935 AND WE CONTINUE TO WORK TOWARDS 4314 03:14:08,935 --> 03:14:12,739 HOPING THAT THIS WILL BECOME OUR 4315 03:14:12,739 --> 03:14:13,773 VISION AND RIGHT NOW THE 4316 03:14:13,773 --> 03:14:15,708 ALZHEIMER'S VISION IS THE ONLY 4317 03:14:15,708 --> 03:14:18,411 INVESTOR. 4318 03:14:18,411 --> 03:14:20,813 WE DON'T HAVE ANY PUBLIC-PRIVATE 4319 03:14:20,813 --> 03:14:22,782 PARTNERS YET. 4320 03:14:22,782 --> 03:14:24,751 DEEPLY PHENOTYPED DATA IS 4321 03:14:24,751 --> 03:14:27,420 ANYTHING UNDERWAY AND WORKING 4322 03:14:27,420 --> 03:14:29,655 CLOSELY TO DO THAT AND HAPPY TO 4323 03:14:29,655 --> 03:14:31,124 TALK ABOUT THAT LATER THOUGH 4324 03:14:31,124 --> 03:14:33,226 SARA WILL BE UP HERE HERSELF 4325 03:14:33,226 --> 03:14:33,526 TALKING. 4326 03:14:33,526 --> 03:14:36,529 IF YOU HAVE ANY QUESTIONS ABOUT 4327 03:14:36,529 --> 03:14:39,665 THAT, PLEASE LET ME KNOW. 4328 03:14:39,665 --> 03:14:41,267 SO ALZ NET IS DESIGN TO WORK 4329 03:14:41,267 --> 03:14:42,168 COLLABORATIVELY WITH OTHER 4330 03:14:42,168 --> 03:14:42,401 STUDIES. 4331 03:14:42,401 --> 03:14:43,436 I HAVE TWO I WANT TO SHARE 4332 03:14:43,436 --> 03:14:45,772 INFORMATION ABOUT. 4333 03:14:45,772 --> 03:14:48,541 THE FIRST IS COVERAGE WITH 4334 03:14:48,541 --> 03:14:49,675 DEVELOPMENT AND THE CENTER FOR 4335 03:14:49,675 --> 03:14:52,645 MEDICARE AND MEDICAID 4336 03:14:52,645 --> 03:14:53,513 REQUIREMENT FOR PHASE IV 4337 03:14:53,513 --> 03:14:54,947 INFORMATION ON SAFETY AND 4338 03:14:54,947 --> 03:14:55,515 EFFICACY. 4339 03:14:55,515 --> 03:14:57,250 THE PRIMARY PURPOSE OF THIS 4340 03:14:57,250 --> 03:14:59,652 STUDY IS TO INVESTIGATE THAT 4341 03:14:59,652 --> 03:15:00,253 LONG-TERM EFFECTIVENESS AND 4342 03:15:00,253 --> 03:15:03,322 SAFETY OF NEW TREATMENTS. 4343 03:15:03,322 --> 03:15:05,191 THIS IS OUR FIRST AFFILIATED 4344 03:15:05,191 --> 03:15:08,961 STUDY BECAUSE CLINICIANS CAN 4345 03:15:08,961 --> 03:15:09,629 UTILIZE ALZ NET TO ENROLL. 4346 03:15:09,629 --> 03:15:13,299 OF PATIENTS AND NO THE DO DOUBLE 4347 03:15:13,299 --> 03:15:18,204 DUTY OF ENROLLING THEM IN CMS 4348 03:15:18,204 --> 03:15:19,772 AND ALZ NET AND WE KNEW THAT WAS 4349 03:15:19,772 --> 03:15:22,508 THE REASON WHY WE HAD IT APPLY 4350 03:15:22,508 --> 03:15:24,744 FOR A CD THOUGH WE AT THE 4351 03:15:24,744 --> 03:15:26,813 ASSOCIATION PUBLICLY STATED WHEN 4352 03:15:26,813 --> 03:15:28,748 THERE'S TRADITIONAL APPROVAL WE 4353 03:15:28,748 --> 03:15:29,816 DID NOT FEEL COVERAGE WITH 4354 03:15:29,816 --> 03:15:32,118 EVIDENCE DEVELOPMENT WAS 4355 03:15:32,118 --> 03:15:34,353 APPROPRIATE FOR CMS TO LAUNCH 4356 03:15:34,353 --> 03:15:37,356 HOWEVER WE ARE HERE. 4357 03:15:37,356 --> 03:15:39,525 ON THE RIGHT SIDE YOU SEE THE 4358 03:15:39,525 --> 03:15:42,595 LATEST ASSIGNED AS A CONTRACT 4359 03:15:42,595 --> 03:15:49,335 WITH AN AFFILIATED STUDY THAT 4360 03:15:49,335 --> 03:15:56,676 FULFILLS THE APPROVAL OF IT TO 4361 03:15:56,676 --> 03:15:58,477 FOLLOW SAFETY OUTCOMES. 4362 03:15:58,477 --> 03:15:59,312 WE'RE COLLABORATING WITH THEM 4363 03:15:59,312 --> 03:16:04,016 AND ARE GOING TO BE CONDUCTING 4364 03:16:04,016 --> 03:16:08,754 REGULAR ALMOST MONTHLY REPORT 4365 03:16:08,754 --> 03:16:09,989 OUTS ON SAFETY DATA TO REPORT 4366 03:16:09,989 --> 03:16:11,424 BACK TO THE FDA. 4367 03:16:11,424 --> 03:16:14,527 WE HAVE BEEN COLLABORATING 4368 03:16:14,527 --> 03:16:15,761 CLOSELY WITH THE FDA THE PAST 4369 03:16:15,761 --> 03:16:17,530 THREE YEARS ON ALZ NET AND THEY 4370 03:16:17,530 --> 03:16:21,634 HAVE IT AS A RECOMMENDED 4371 03:16:21,634 --> 03:16:24,737 REGISTRY FOR THE CLINGS AND 4372 03:16:24,737 --> 03:16:27,773 PROVIDERS TO PUT THEIR PATIENT'S 4373 03:16:27,773 --> 03:16:31,143 DATA IN TO HELP FDA AND ALL THE 4374 03:16:31,143 --> 03:16:32,178 COMMUNITY UNDERSTAND HOW THESE 4375 03:16:32,178 --> 03:16:34,814 DRUGS ARE BEHAVING IN REAL WORLD 4376 03:16:34,814 --> 03:16:36,749 SETTING AND ALIGNED WITH THE 4377 03:16:36,749 --> 03:16:37,717 WORK WE'RE DOING. 4378 03:16:37,717 --> 03:16:39,185 I THINK WE'LL HEAR FROM THE FDA 4379 03:16:39,185 --> 03:16:39,619 LATER TODAY. 4380 03:16:39,619 --> 03:16:43,322 ONE THING I WANTED TO FOCUS ON 4381 03:16:43,322 --> 03:16:43,656 IS ARIA. 4382 03:16:43,656 --> 03:16:44,991 I'LL BREEZE THROUGH THIS BECAUSE 4383 03:16:44,991 --> 03:16:45,958 WE KNOW WHAT IT IS. 4384 03:16:45,958 --> 03:16:47,593 IT'S A SAFETY THINGS WE'RE 4385 03:16:47,593 --> 03:16:51,264 MANAGING TO LOOK AT THROUGH NOT 4386 03:16:51,264 --> 03:16:55,701 ONLY THE PMR REGISTRY BUT THE 4387 03:16:55,701 --> 03:16:57,536 COVERAGE STUDY. 4388 03:16:57,536 --> 03:17:00,840 IN 2010 THE FDA DID NOTICE THERE 4389 03:17:00,840 --> 03:17:03,643 WERE ANOMALIES HAPPENING ACROSS 4390 03:17:03,643 --> 03:17:06,045 THE CLASS OF MONOCLONAL 4391 03:17:06,045 --> 03:17:06,746 ANTIBODIES. 4392 03:17:06,746 --> 03:17:10,349 WE CREATED A WORK GROUP THAT IN 4393 03:17:10,349 --> 03:17:15,588 2011 PUBLISHED THE PAPER IN 4394 03:17:15,588 --> 03:17:18,958 ORDER TO NAME ARIA E AND H. 4395 03:17:18,958 --> 03:17:20,359 TODAY WE'RE RE-EVALUATING WHAT 4396 03:17:20,359 --> 03:17:22,929 THE WORK GROUP LOOKED AT THAT 4397 03:17:22,929 --> 03:17:24,463 TIME. 4398 03:17:24,463 --> 03:17:26,766 WE HAVE NOT A LOT OF INFORMATION 4399 03:17:26,766 --> 03:17:30,469 ABOUT WHAT THE EDEMA WAS YOU 4400 03:17:30,469 --> 03:17:33,739 CAUSED IN THE DRUG STUDIED AN 4401 03:17:33,739 --> 03:17:36,409 STILL DON'T KNOW AS MUCH AS WE 4402 03:17:36,409 --> 03:17:38,844 WANT BUT WANT TO KNOW MORE. 4403 03:17:38,844 --> 03:17:44,583 WE HAVE TWO FEDERAL PARTNERS THE 4404 03:17:44,583 --> 03:17:49,121 NIA WITH THE WORK GROUP MEMBERS 4405 03:17:49,121 --> 03:17:51,023 AND THEY'RE INSIGHTS BUT THEY'RE 4406 03:17:51,023 --> 03:17:53,225 NOT OFFICIAL WORK GROUP MEMBERS 4407 03:17:53,225 --> 03:17:54,994 AND WHY THERE'S AN ASTERISK 4408 03:17:54,994 --> 03:17:55,194 THERE. 4409 03:17:55,194 --> 03:17:55,728 THESE ARE QUESTIONS WE'RE 4410 03:17:55,728 --> 03:18:00,333 ASKING. 4411 03:18:00,333 --> 03:18:02,101 YOU THINK WE UNDERSTAND WE KNOW 4412 03:18:02,101 --> 03:18:04,737 MORE NOT ENOUGH. 4413 03:18:04,737 --> 03:18:06,973 WE'RE WORKING WITH THE FDA TO 4414 03:18:06,973 --> 03:18:09,208 UNDERSTAND PATIENT LEVEL DATA 4415 03:18:09,208 --> 03:18:10,142 AND HAVE MANY COMPANIES ASKING 4416 03:18:10,142 --> 03:18:12,411 THEM TO SHARE THEIR DATA WITH US 4417 03:18:12,411 --> 03:18:14,914 ON ARIA. 4418 03:18:14,914 --> 03:18:18,918 YOU CAN IMAGINE THERE ARE SUM 4419 03:18:18,918 --> 03:18:20,519 RELUCTANCE FOR COMPANIES TO 4420 03:18:20,519 --> 03:18:21,420 SHARE DATA BUT WE'RE WORKING 4421 03:18:21,420 --> 03:18:23,122 HARD ON TRYING TO GET IT. 4422 03:18:23,122 --> 03:18:26,025 THIS IS MY FINAL SLIDE. 4423 03:18:26,025 --> 03:18:27,626 I WANTED TO SHARE OUR VISION. 4424 03:18:27,626 --> 03:18:30,896 YOU CAN PUT ANY DEMENTIA IN THE 4425 03:18:30,896 --> 03:18:32,698 MIDDLE BUT WE'LL DO ALZHEIMER'S 4426 03:18:32,698 --> 03:18:34,767 BECAUSE THIS IS THE SUMMIT. 4427 03:18:34,767 --> 03:18:35,868 WE KNOW THERE ARE BRAIN CHANGES 4428 03:18:35,868 --> 03:18:36,802 THAT HAPPEN AND TALKED ABOUT 4429 03:18:36,802 --> 03:18:38,537 THEM AND NOT ONLY WITH 4430 03:18:38,537 --> 03:18:39,472 BIOMARKERS BUT PERHAPS OMICS 4431 03:18:39,472 --> 03:18:42,141 DATA WE WILL BE ABLE TO 4432 03:18:42,141 --> 03:18:44,610 DETERMINE WHAT UNDER LIES THE 4433 03:18:44,610 --> 03:18:44,844 CHANGES. 4434 03:18:44,844 --> 03:18:48,014 AND ULTIMATELY WE WANT THERAPIES 4435 03:18:48,014 --> 03:18:48,414 FOR EACH OF THOSE. 4436 03:18:48,414 --> 03:18:51,117 AND THAT IS GOING TO BE A 4437 03:18:51,117 --> 03:18:54,020 PERSONALIZED APPROACH AND WE'RE 4438 03:18:54,020 --> 03:18:57,423 CLOSER THAN EVER AND I'VE COME 4439 03:18:57,423 --> 03:18:59,959 OUT WITH MORE HOPE AND THIS IS A 4440 03:18:59,959 --> 03:19:01,027 SLIDE MODIFIED FROM RON 4441 03:19:01,027 --> 03:19:01,660 PETERSON. 4442 03:19:01,660 --> 03:19:04,030 IN PARTICULAR WE HAVE SOME DRUGS 4443 03:19:04,030 --> 03:19:06,065 THAT ARE GOING TO TACKLE THIS 4444 03:19:06,065 --> 03:19:08,734 SIDE OF THE CIRCLE BUT ON TOP OF 4445 03:19:08,734 --> 03:19:11,404 THAT YOU HEARD FROM LAURA BAKER 4446 03:19:11,404 --> 03:19:12,972 AND OTHERS RISK FACTOR 4447 03:19:12,972 --> 03:19:13,572 INTERVENTIONS CAN OFFER GREAT 4448 03:19:13,572 --> 03:19:18,511 HOPE. 4449 03:19:18,511 --> 03:19:23,282 THAT IS A GOOD WRAP AROUND HOW 4450 03:19:23,282 --> 03:19:25,117 WE AT THE ALZHEIMER'S 4451 03:19:25,117 --> 03:19:27,620 ASSOCIATION AND EXCITED TO 4452 03:19:27,620 --> 03:19:28,687 PARTICIPATE IN THE PANEL AND 4453 03:19:28,687 --> 03:19:30,423 THANK YOU FOR THE LEADERSHIP AND 4454 03:19:30,423 --> 03:19:32,758 LOOKING FORWARD TO THE 4455 03:19:32,758 --> 03:19:33,125 DISCUSSION. 4456 03:19:33,125 --> 03:19:36,729 I WANT TO THANK OUR PARTNERS AND 4457 03:19:36,729 --> 03:19:43,469 GILL AND MIKE AND DR. SNIDER AND 4458 03:19:43,469 --> 03:19:44,737 EDELMIER. 4459 03:19:44,737 --> 03:19:52,745 THANK YOU VERY MUCH. 4460 03:19:52,745 --> 03:20:00,986 >> I'D LIKE TO INVITE THE 4461 03:20:00,986 --> 03:20:01,520 FIVE-PARENT PRESENTATION 4462 03:20:01,520 --> 03:20:11,697 SPEAKERS. 4463 03:20:30,883 --> 03:20:38,257 LIKED TO INVITE DR. CHRIS 4464 03:20:38,257 --> 03:20:39,024 SWANSON-FISHER TO START THE 4465 03:20:39,024 --> 03:20:39,825 FIRST PRESENTATION. 4466 03:20:39,825 --> 03:20:41,594 >> THANK YOU AND GOOD MORNING OR 4467 03:20:41,594 --> 03:20:46,966 GOOD AFTERNOON TO EVERYBODY. 4468 03:20:46,966 --> 03:20:53,439 I'M PROGRAM DIRECTOR AT NINDS 4469 03:20:53,439 --> 03:20:55,541 THANK YOU FOR THE LEADERSHIP OF 4470 03:20:55,541 --> 03:20:56,742 THE SUMMIT AND PUTTING TOGETHER 4471 03:20:56,742 --> 03:20:58,410 THIS CRUCIAL SESSION TODAY. 4472 03:20:58,410 --> 03:21:01,347 I KNOW MANY HAVE HEARD OVER THE 4473 03:21:01,347 --> 03:21:03,215 LAST TWO DAYS AS WELL AS WE 4474 03:21:03,215 --> 03:21:04,950 BELIEVE JUST NOW FROM ANNA ABOUT 4475 03:21:04,950 --> 03:21:09,121 THE BREADTH OF THE DATA TO BE 4476 03:21:09,121 --> 03:21:12,625 EXPLORED IN THE ANG 80 KNOWLEDGE 4477 03:21:12,625 --> 03:21:14,260 PORTAL AND PROVIDE AN OVERVIEW 4478 03:21:14,260 --> 03:21:17,563 WHERE THE ACCELERATING MEDICINE 4479 03:21:17,563 --> 03:21:18,764 PARTNERSHIP FOR PARKINSON'S 4480 03:21:18,764 --> 03:21:20,399 DISEASE IS AND WHERE WE'RE 4481 03:21:20,399 --> 03:21:23,869 HEADING NEXT. 4482 03:21:23,869 --> 03:21:27,673 AMP AD IS A PUBLIC-PRIVATE 4483 03:21:27,673 --> 03:21:32,745 PARTNERSHIP AS WELL AS INDUSTRY 4484 03:21:32,745 --> 03:21:38,117 PARTNERS AND THE MICHAEL J FOX 4485 03:21:38,117 --> 03:21:40,085 FOUNDATION AND ALLIANCE FOR 4486 03:21:40,085 --> 03:21:40,386 PARKINSON'S. 4487 03:21:40,386 --> 03:21:43,522 IT WAS LAUNCHED IN 2018 WITH THE 4488 03:21:43,522 --> 03:21:47,159 GOAL TO HELP ADVANCE PATHWAYS 4489 03:21:47,159 --> 03:21:49,995 AND BIOMARKERS FOR PARKINSON'S 4490 03:21:49,995 --> 03:21:51,363 DISEASE TO ENABLE CLINICAL TRIAL 4491 03:21:51,363 --> 03:21:54,033 DESIGN BY DEVELOPING AND LAMPING 4492 03:21:54,033 --> 03:21:56,735 THE AMP KNOWLEDGE PLATFORM. 4493 03:21:56,735 --> 03:21:58,103 WE'RE FAMILIAR WITH PLATFORMS WE 4494 03:21:58,103 --> 03:22:00,272 HEARD ABOUT OVER THE LAST COUPLE 4495 03:22:00,272 --> 03:22:03,342 DAYS AND IN THE SESSION. 4496 03:22:03,342 --> 03:22:07,613 WE GENERATED ROBUST MOLECULAR 4497 03:22:07,613 --> 03:22:08,480 CHARACTERIZATION AND IDENTIFYING 4498 03:22:08,480 --> 03:22:09,648 NOVEL BIOMARKERS AN TARGETS. 4499 03:22:09,648 --> 03:22:14,053 YOU CAN SEE ON THE RIGHT WE HAVE 4500 03:22:14,053 --> 03:22:17,423 EIGHT UNIFIED COHORT WITHIN THE 4501 03:22:17,423 --> 03:22:17,690 PLATFORM. 4502 03:22:17,690 --> 03:22:24,363 THEY HAVE LONGITUDINAL 4503 03:22:24,363 --> 03:22:32,404 HARMONIZED CLINICAL DATA AND WE 4504 03:22:32,404 --> 03:22:34,907 HAVE RNA SEQUENCING DATA FROM 4505 03:22:34,907 --> 03:22:40,346 BLOOD AS WELL AS MATCH PLASMA 4506 03:22:40,346 --> 03:22:42,781 AND LONGITUDINAL PROTEOMICS DATA 4507 03:22:42,781 --> 03:22:45,951 AND RNA SEQUENCING DATA AS WELL. 4508 03:22:45,951 --> 03:22:49,655 AND FEDERATED DATA FROM THE 4509 03:22:49,655 --> 03:22:53,993 PARKINSON'S GP2 YOU HEARD FROM 4510 03:22:53,993 --> 03:22:58,964 MONDAY AS WELL TO PROVIDE 4511 03:22:58,964 --> 03:23:00,366 GENOTYPING FROM PEOPLE WITH 4512 03:23:00,366 --> 03:23:04,403 PARKINSON'S DISEASE AND RELATED 4513 03:23:04,403 --> 03:23:04,670 DISORDERS. 4514 03:23:04,670 --> 03:23:08,440 A CORNERSTONE IS DATA 4515 03:23:08,440 --> 03:23:08,807 DEMOCRATIZATION. 4516 03:23:08,807 --> 03:23:13,245 I THINK IT'S BEEN ENABLED 4517 03:23:13,245 --> 03:23:19,051 THROUGH OUR AMP PLATFORM AND AN 4518 03:23:19,051 --> 03:23:21,587 ENVIRONMENT WORK WITH PARTNERS 4519 03:23:21,587 --> 03:23:24,757 TO LEVERAGE TERRA WORK SPACES IN 4520 03:23:24,757 --> 03:23:27,126 THE CLOUD AND ABLE TO FEDERATE 4521 03:23:27,126 --> 03:23:29,862 THE DATA THROUGH GP2 AND 4522 03:23:29,862 --> 03:23:32,164 CURRENTLY HAVE OVER 800 USERS 4523 03:23:32,164 --> 03:23:33,966 WHO HAVE ACCESSED THE DATA FROM 4524 03:23:33,966 --> 03:23:36,035 AROUND THE WORLD AND AT THE SAME 4525 03:23:36,035 --> 03:23:39,405 TIME WE WANT TO BUILD UPON THE 4526 03:23:39,405 --> 03:23:41,473 KNOWLEDGE PORTAL BY RECENTLY 4527 03:23:41,473 --> 03:23:44,143 LAUNCHING THE TARGET EXPLORER 4528 03:23:44,143 --> 03:23:46,512 TOOL MODELLED AT THE PLATFORM TO 4529 03:23:46,512 --> 03:23:48,714 SERVE AS A PUBLIC RESOURCE FOR 4530 03:23:48,714 --> 03:23:51,050 OPEN ACCESS TO NOMINATE GENES 4531 03:23:51,050 --> 03:23:52,584 AND PROTEINS FROM MODELLED FROM 4532 03:23:52,584 --> 03:23:55,688 THE DATA THAT CAN BE IMPLICATED 4533 03:23:55,688 --> 03:23:59,491 IN PARKINSON'S DISEASE. 4534 03:23:59,491 --> 03:24:00,726 AND THERE'S WORK STREAMS 4535 03:24:00,726 --> 03:24:03,062 FOCUSSING ON THE BIOMARKERS AND 4536 03:24:03,062 --> 03:24:06,999 KNOX DRUG TARGETS AND CURRENTLY 4537 03:24:06,999 --> 03:24:12,938 WE HAVE OVER 13,000 TRAR -- 4538 03:24:12,938 --> 03:24:16,008 TARGETS ON PROTEOMIC DATA SETS. 4539 03:24:16,008 --> 03:24:17,910 BASED ON RESOURCES ESTABLISHED 4540 03:24:17,910 --> 03:24:19,211 THROUGH THE AMP PHASE FROM 2018 4541 03:24:19,211 --> 03:24:22,981 TO THE LAST YEAR A NUMBER OF KEY 4542 03:24:22,981 --> 03:24:24,516 STAKEHOLDERS INCLUDING THE AC 4543 03:24:24,516 --> 03:24:26,618 FIX PARTNERS AND SUBJECT MATTER 4544 03:24:26,618 --> 03:24:28,987 EXPERTS AND KEY OPINION LEADERS 4545 03:24:28,987 --> 03:24:30,589 STARTED TO LOOK AT THE SUCCESS 4546 03:24:30,589 --> 03:24:32,224 OF PHASE 1 AND START TO THINK 4547 03:24:32,224 --> 03:24:33,459 WHERE WE CAN MOVE NEXT WHICH WE 4548 03:24:33,459 --> 03:24:36,762 WANT TO ENABLE THE PRECISION 4549 03:24:36,762 --> 03:24:39,665 MEDICINE APPROACH. 4550 03:24:39,665 --> 03:24:41,533 WE DECIDED TO LOOK BEYOND 4551 03:24:41,533 --> 03:24:45,571 PARKINSON'S DISEASE COHORTS AND 4552 03:24:45,571 --> 03:24:52,745 LOOK INTO OTHER DISEASES AND 4553 03:24:52,745 --> 03:24:53,779 PRODROMAL PARKINSON'S DISEASE 4554 03:24:53,779 --> 03:24:56,749 AND OTHER ATYPICAL 4555 03:24:56,749 --> 03:24:57,082 PARKINSONISMS. 4556 03:24:57,082 --> 03:24:59,318 THE NEW PARTNERSHIP CALLED THE 4557 03:24:59,318 --> 03:25:01,820 AMP PARKINSON'S DISEASE AND ED 4558 03:25:01,820 --> 03:25:06,258 DISORDER OR AMP PDRD WAS 4559 03:25:06,258 --> 03:25:08,727 OFFICIALLY LAUNCHED THIS PAST 4560 03:25:08,727 --> 03:25:17,002 JULY AND SIGNED ON NINDS AND 4561 03:25:17,002 --> 03:25:21,473 INDUSTRY PARTNERS. 4562 03:25:21,473 --> 03:25:22,207 WE ARE GROWING. 4563 03:25:22,207 --> 03:25:27,279 IF YOU'RE INTERESTED IN LEARNING 4564 03:25:27,279 --> 03:25:31,150 MORE ABOUT THE INITIATIVE ARD 4565 03:25:31,150 --> 03:25:32,851 CONTRIBUTING DATA FOR 4566 03:25:32,851 --> 03:25:34,153 PARKINSON'S OR OTHER RELATED 4567 03:25:34,153 --> 03:25:35,754 DISORDER COHORTS, PLEASE DO 4568 03:25:35,754 --> 03:25:38,657 REACH OUT TO ME AND IF YOU'RE 4569 03:25:38,657 --> 03:25:40,259 INTERESTED AS A PRIVATE PARTNER 4570 03:25:40,259 --> 03:25:42,027 AND POTENTIALLY JOINING THE 4571 03:25:42,027 --> 03:25:44,730 ORGANIZATION I CAN CERTAINLY 4572 03:25:44,730 --> 03:25:47,866 ANTIBIOTIC -- INTRODUCE YOU TO 4573 03:25:47,866 --> 03:25:49,568 MY COLLEAGUES TO FACILITATE THE 4574 03:25:49,568 --> 03:25:50,436 COVERINGS. 4575 03:25:50,436 --> 03:25:52,438 WE'LL EXPAND THE WORK IN PHASE 1 4576 03:25:52,438 --> 03:25:54,740 INCLUDING DISCOVERY AND 4577 03:25:54,740 --> 03:25:56,074 VALIDATION OF BIOMARKERS. 4578 03:25:56,074 --> 03:25:57,910 WE'VE BEEN HEARING ABOUT THE 4579 03:25:57,910 --> 03:26:00,446 SEED AMPLIFICATION ASSAY. 4580 03:26:00,446 --> 03:26:04,149 I WILL NOTE MY COLLEAGUE DIANNE 4581 03:26:04,149 --> 03:26:06,885 STEVENSON IS IN THE AUDIENCE AND 4582 03:26:06,885 --> 03:26:08,720 THE CRITICAL PATH TO PARKINSON'S 4583 03:26:08,720 --> 03:26:10,489 DISEASE SUBMITTED A LETTER OF 4584 03:26:10,489 --> 03:26:12,691 SUPPORT TO THE FDA WHICH 4585 03:26:12,691 --> 03:26:14,693 RECEIVED A SUPPORT FROM THE FDA 4586 03:26:14,693 --> 03:26:19,698 TO ENABLE THE UTILITY OF THE CSF 4587 03:26:19,698 --> 03:26:24,102 AMPLIFICATION ASSAY TO ENRICH 4588 03:26:24,102 --> 03:26:25,737 FOR CLINICAL TRIAL DESIGN AS A 4589 03:26:25,737 --> 03:26:27,339 RISK SUSCEPTIBILITY MARKER AND I 4590 03:26:27,339 --> 03:26:29,374 THINK THERE'S SYNERGY WITH THAT 4591 03:26:29,374 --> 03:26:31,844 WORK FOR WHERE WE'RE GOING IN 4592 03:26:31,844 --> 03:26:36,181 THE NEXT PHASE OF AMP PRAD AND 4593 03:26:36,181 --> 03:26:42,654 ENABLE MULTI SCALE ANALYSIS 4594 03:26:42,654 --> 03:26:43,522 NETWORK. 4595 03:26:43,522 --> 03:26:45,691 >> OUR NEXT SPEAKER IS 4596 03:26:45,691 --> 03:26:48,727 DR. TIMOTHY HOHMAN FROM 4597 03:26:48,727 --> 03:26:52,631 VANDERBILT UNIVERSITY. 4598 03:26:52,631 --> 03:26:55,934 >> IT'S MY PRIVILEGE TO PRESENT 4599 03:26:55,934 --> 03:26:57,669 ON THE ALZHEIMER'S SEQUENCING 4600 03:26:57,669 --> 03:26:59,972 PROJECT PHENOTYPE HARMONIZATION 4601 03:26:59,972 --> 03:27:00,739 CONSORTIUM. 4602 03:27:00,739 --> 03:27:02,574 YOU HEARD EARLIER THIS WEEK 4603 03:27:02,574 --> 03:27:03,675 ABOUT THE ALZHEIMER'S SEQUENCING 4604 03:27:03,675 --> 03:27:05,611 PROJECT AND THE AMAZING DIVERSE 4605 03:27:05,611 --> 03:27:07,513 DATA BEING COLLECTED AS PART OF 4606 03:27:07,513 --> 03:27:08,313 THE PROJECT. 4607 03:27:08,313 --> 03:27:10,949 AND A LOT OF THE DATA SETS THAT 4608 03:27:10,949 --> 03:27:13,218 COME IN TO THE SEQUENCING 4609 03:27:13,218 --> 03:27:14,953 PROJECTS COME FROM DIFFERENT 4610 03:27:14,953 --> 03:27:16,188 COHORTS THAT USE DIFFERENT 4611 03:27:16,188 --> 03:27:17,155 PROTOCOLS IN DATA COLLECTION. 4612 03:27:17,155 --> 03:27:18,357 WE'VE HAD TO TACKLE THE 4613 03:27:18,357 --> 03:27:20,859 CHALLENGE OF HOW DO WE INTEGRATE 4614 03:27:20,859 --> 03:27:22,227 THOSE DATA COLLECTED IN VERY 4615 03:27:22,227 --> 03:27:25,964 DIFFERENT WAYS AND MAKE THEM 4616 03:27:25,964 --> 03:27:27,699 AVAILABLE TO RESEARCHERS FOR 4617 03:27:27,699 --> 03:27:28,433 GENOMIC DATA ANALYSIS. 4618 03:27:28,433 --> 03:27:30,636 WE ESTABLISHED A TEAM OF ABOUT 4619 03:27:30,636 --> 03:27:35,240 13 DOMAIN EXPERTS AROUND THE 4620 03:27:35,240 --> 03:27:36,074 COUNTRY WHO ALREADY HAD 4621 03:27:36,074 --> 03:27:38,744 ESTABLISHED METHODOLOGIES FOR 4622 03:27:38,744 --> 03:27:39,678 THE DIFFERENT DOMAINS WE HAVE 4623 03:27:39,678 --> 03:27:41,013 LISTED ON THE LEFT. 4624 03:27:41,013 --> 03:27:43,882 WE HARMONIZED DATA AND DOMAINS 4625 03:27:43,882 --> 03:27:50,188 OF RISK FACTORS AND COGNITIVE 4626 03:27:50,188 --> 03:27:52,524 DATA WITH DIFFUSION AND 4627 03:27:52,524 --> 03:27:53,458 STRUCTURAL IMAGE AND NEURAL 4628 03:27:53,458 --> 03:27:54,526 PATHOLOGY DATA. 4629 03:27:54,526 --> 03:27:58,931 WHEN WE DO THE DATA 4630 03:27:58,931 --> 03:28:00,332 HARMONIZATION THE GOAL IS TO 4631 03:28:00,332 --> 03:28:01,133 MAKE AVAILABLE FOR SEQUENCE 4632 03:28:01,133 --> 03:28:02,668 ANALYSIS AND INCLUDE EVERYONE IN 4633 03:28:02,668 --> 03:28:04,036 THE COHORT. 4634 03:28:04,036 --> 03:28:06,672 WE ALREADY HARMONIZED COGNITIVE 4635 03:28:06,672 --> 03:28:08,140 DATA FOR MORE THAN 80,000 4636 03:28:08,140 --> 03:28:11,310 PARTICIPANTS AND MADE THEM 4637 03:28:11,310 --> 03:28:14,179 AVAILABLE TO THE COMMUNITY. 4638 03:28:14,179 --> 03:28:15,914 ALL THE DATA ARE AVAILABLE AND 4639 03:28:15,914 --> 03:28:18,684 SEND THEM BACK TO THE INDIVIDUAL 4640 03:28:18,684 --> 03:28:20,519 COHORTS FOR PEOPLE USING THE 4641 03:28:20,519 --> 03:28:23,589 DATA AND JUST WANT HARMONIZED 4642 03:28:23,589 --> 03:28:25,324 PHENOTYPES FOR YOUR COHORT FOR 4643 03:28:25,324 --> 03:28:26,525 ADNI OR THE A4 STUDY YOU HEARD 4644 03:28:26,525 --> 03:28:35,934 ABOUT TODAY. 4645 03:28:35,934 --> 03:28:36,802 THERE'S DIFFERENT PLATFORMS SET 4646 03:28:36,802 --> 03:28:38,870 UP TO SOLVE DIFFERENT TYPES OF 4647 03:28:38,870 --> 03:28:40,739 PROBLEMS AND ONE WAS SET UP TO 4648 03:28:40,739 --> 03:28:44,776 DEAL WITH SHARING GENOMIC DATA 4649 03:28:44,776 --> 03:28:48,714 AND SHARE IMAGING DATA. 4650 03:28:48,714 --> 03:28:50,549 WE HELPED FACILITATE A NICE 4651 03:28:50,549 --> 03:28:51,583 COLLABORATION TO MAKE IT EASIER 4652 03:28:51,583 --> 03:28:54,186 ON THE USERS AND MAKE IT 4653 03:28:54,186 --> 03:29:00,726 POSSIBLE TO ACCESS RAW DATA FOR 4654 03:29:00,726 --> 03:29:02,060 USERS OF THAT. 4655 03:29:02,060 --> 03:29:05,497 AND WE HEARD AN OPPORTUNITY TO 4656 03:29:05,497 --> 03:29:08,367 DO WORK SHOP AND WEBINARS. 4657 03:29:08,367 --> 03:29:10,135 EACH YEAR WE PUT ON A WORKSHOP 4658 03:29:10,135 --> 03:29:12,037 WHERE WE GIVE HANDS ON TRAINING 4659 03:29:12,037 --> 03:29:13,705 TO THE RESEARCH COMMUNITY TO 4660 03:29:13,705 --> 03:29:15,841 LEARN HU TO DO DATA 4661 03:29:15,841 --> 03:29:16,842 HARMONIZATION, HOW TO TAKE THE 4662 03:29:16,842 --> 03:29:19,111 PHENOTYPES WE GENERATED AN USE 4663 03:29:19,111 --> 03:29:22,214 THEM IN YOUR OWN ANALYSES AND 4664 03:29:22,214 --> 03:29:22,914 WINDOW TO THE TYPE OF WORK WE 4665 03:29:22,914 --> 03:29:27,052 DO. 4666 03:29:27,052 --> 03:29:30,989 AND ON THE TOP RIGHT WE 4667 03:29:30,989 --> 03:29:32,024 INTEGRATED WITH GREAT PROGRAMS 4668 03:29:32,024 --> 03:29:33,592 YOU HEARD ABOUT TODAY. 4669 03:29:33,592 --> 03:29:36,461 WE WORKED WITH THE AD KNOWLEDGE 4670 03:29:36,461 --> 03:29:38,397 PORTAL FOR NEURAL PATHOLOGY DATA 4671 03:29:38,397 --> 03:29:43,335 AND STARTED WORKING WITH CARD 4672 03:29:43,335 --> 03:29:44,736 AND THE GPT 2 PLATFORM ON COMMON 4673 03:29:44,736 --> 03:29:47,472 DATA ELEMENTS TO BE EXTRACTED 4674 03:29:47,472 --> 03:29:51,677 FROM NEURAL PATH OLOGY SLIDES 4675 03:29:51,677 --> 03:29:54,646 AND INTEGRATE ACROSS DISEASES. 4676 03:29:54,646 --> 03:29:56,748 WE WORKED WITH THE NATIONAL 4677 03:29:56,748 --> 03:29:57,649 ALZHEIMER'S COORDINATING CENTER 4678 03:29:57,649 --> 03:29:59,484 YOU'LL HEAR MORE ABOUT IN 4679 03:29:59,484 --> 03:30:03,121 MINUTES AND HAD A CHANCE TO WORK 4680 03:30:03,121 --> 03:30:06,058 WITH FOLKS WHO DO ARTIFICIAL 4681 03:30:06,058 --> 03:30:07,659 INTELLIGENCE AND MACHINE 4682 03:30:07,659 --> 03:30:07,926 LEARNING. 4683 03:30:07,926 --> 03:30:09,428 THEY'RE HELPFUL FOR DATA 4684 03:30:09,428 --> 03:30:09,761 HARMONIZATION. 4685 03:30:09,761 --> 03:30:11,563 WE USE THE APPROACHES UP OUR 4686 03:30:11,563 --> 03:30:13,031 HARMONIZATION METHODS BUT THE 4687 03:30:13,031 --> 03:30:14,666 REASON WE WERE ESTABLISHED WAS 4688 03:30:14,666 --> 03:30:17,836 BECAUSE A LOT OF PEOPLE WHO DO 4689 03:30:17,836 --> 03:30:19,371 A.I. AND M.L. WORK WATCH THE TO 4690 03:30:19,371 --> 03:30:21,306 USE DATA FROM GENOMICS AND 4691 03:30:21,306 --> 03:30:24,643 NEURAL IMAGES BUT MAY NOT HAVE 4692 03:30:24,643 --> 03:30:25,477 THE EXPERTISE. 4693 03:30:25,477 --> 03:30:26,945 ONE HUGE DELIVERABLE ARE THE 4694 03:30:26,945 --> 03:30:29,481 A.I. READY DATA SETS THAT CAN GO 4695 03:30:29,481 --> 03:30:31,049 INTO WORK GROUPS THAT HAVE 4696 03:30:31,049 --> 03:30:32,684 EXPERTISE IN THAT AREA AND 4697 03:30:32,684 --> 03:30:33,985 ACCELERATE SOME OF THE 4698 03:30:33,985 --> 03:30:35,854 DISCOVERIES THAT CAN COME FROM 4699 03:30:35,854 --> 03:30:37,089 THAT AND YOU'LL HEAR MORE ON 4700 03:30:37,089 --> 03:30:42,227 THAT IN A FEW MINUTES. 4701 03:30:42,227 --> 03:30:44,229 ONE OTHER COLLABORATION IS WITH 4702 03:30:44,229 --> 03:30:45,664 A MILLION VETERANS PROGRAM AS 4703 03:30:45,664 --> 03:30:46,732 PART OF THE V.A. 4704 03:30:46,732 --> 03:30:49,534 THIS IS ONE OF THE FIRST 4705 03:30:49,534 --> 03:30:50,569 COLLABORATIONS BETWEEN THE V.A. 4706 03:30:50,569 --> 03:30:52,738 AND NIA TO MAKE IT POSSIBLE TO 4707 03:30:52,738 --> 03:30:56,441 DO GENOMIC DATA ANALYSIS ACROSS 4708 03:30:56,441 --> 03:30:57,342 THAT REALLY CDC PROGRAM IN THE 4709 03:30:57,342 --> 03:30:59,111 V.A. AND THE ADSP. 4710 03:30:59,111 --> 03:31:01,513 WE JUST STARTED THIS PROJECT AND 4711 03:31:01,513 --> 03:31:04,449 GOT UNDERWAY AND EXCITED TO 4712 03:31:04,449 --> 03:31:05,650 INTEGRATE ELECTRONIC HEALTH 4713 03:31:05,650 --> 03:31:08,053 REPORT DATA TO GET PHENOTYPES 4714 03:31:08,053 --> 03:31:11,022 AND PULLING IN CLINICAL IMAGES 4715 03:31:11,022 --> 03:31:14,826 TO PULL IN AD RELEVANT FROM DATA 4716 03:31:14,826 --> 03:31:16,361 AND WITH THE GOAL OF DOING JOINT 4717 03:31:16,361 --> 03:31:17,229 ANALYSIS IN THE FUTURE. 4718 03:31:17,229 --> 03:31:18,830 FINALLY YOU CAN READ MORE ABOUT 4719 03:31:18,830 --> 03:31:24,736 THE DATA WE HAVE HERE ON OUR 4720 03:31:24,736 --> 03:31:32,210 DATA EXPLORER TOOL AND WE TRY TO 4721 03:31:32,210 --> 03:31:34,980 MAKE THE DATA ACCESSIBLE TO 4722 03:31:34,980 --> 03:31:36,581 FOLKS ACROSS DIFFERENT LEVELS OF 4723 03:31:36,581 --> 03:31:36,948 EXPERTISE. 4724 03:31:36,948 --> 03:31:39,384 IF YOU'RE AN IMAGEER AND WANT TO 4725 03:31:39,384 --> 03:31:41,586 WORK WITH RAW IMAGING DATA IT'S 4726 03:31:41,586 --> 03:31:43,021 AVAILABLE BUT IF YOU NEVER 4727 03:31:43,021 --> 03:31:44,956 LOOKED AT AN IMAGE BUT 4728 03:31:44,956 --> 03:31:47,559 INTERESTED IN GENOMIC ANALYSIS 4729 03:31:47,559 --> 03:31:52,464 ON AMYLOID STAT STATUS AND 4730 03:31:52,464 --> 03:31:54,733 THOUGH THE DATA ARE COMING FROM 4731 03:31:54,733 --> 03:31:56,468 COMPLEX IMAGING ANALYSES. 4732 03:31:56,468 --> 03:32:03,675 AND SO HOPEFULLY YOU'LL CHECK 4733 03:32:03,675 --> 03:32:06,778 US -- US OUT AND THE 4734 03:32:06,778 --> 03:32:08,680 PARTICIPANTS WHO MAKE THEIR DATA 4735 03:32:08,680 --> 03:32:09,614 AVAILABLE FOR US TO MAKE AN 4736 03:32:09,614 --> 03:32:10,081 IMPACT ON THE DISEASE. 4737 03:32:10,081 --> 03:32:19,658 THANK YOU VERY MUCH. 4738 03:32:19,658 --> 03:32:21,660 >> THE NEXT SPEAKER IS DR. BIBER 4739 03:32:21,660 --> 03:32:22,160 FROM THE UNIVERSITY OF 4740 03:32:22,160 --> 03:32:29,067 WASHINGTON. 4741 03:32:29,067 --> 03:32:29,968 >> HELLO. 4742 03:32:29,968 --> 03:32:31,069 THANKS SO MUCH TO THE ORGANIZERS 4743 03:32:31,069 --> 03:32:32,737 FOR INVITING ME. 4744 03:32:32,737 --> 03:32:33,872 I'M THRILLED TO HAVE THE 4745 03:32:33,872 --> 03:32:35,040 OPPORTUNITY TO LEARN FROM ALL OF 4746 03:32:35,040 --> 03:32:41,479 YOU AND TO HIGHLIGHT THE WORK TO 4747 03:32:41,479 --> 03:32:42,948 REVOLUTIONIZE INTEROPERABILITY 4748 03:32:42,948 --> 03:32:47,519 AND DISCOVERY AND ACCESS FOR 4749 03:32:47,519 --> 03:32:48,720 ADRC PROGRAM DATA. 4750 03:32:48,720 --> 03:32:50,922 IT'S THE CENTRALIZED 4751 03:32:50,922 --> 03:32:52,224 COLLABORATORY AND COMMUNICATION 4752 03:32:52,224 --> 03:32:54,359 HUB FOR THE ALZHEIMER'S DISEASE 4753 03:32:54,359 --> 03:32:56,561 RESEARCH CENTERS PROGRAM OF 35 4754 03:32:56,561 --> 03:32:59,064 CENTERS ACROSS 24 STATES. 4755 03:32:59,064 --> 03:33:02,267 OVER THE PAST 2R5 YEARS WE BUILT 4756 03:33:02,267 --> 03:33:06,605 ONE OF THE LARGEST AND 4757 03:33:06,605 --> 03:33:07,539 COMPREHENSIVE LONGITUDINAL 4758 03:33:07,539 --> 03:33:08,173 NEUROPATHOLOGICAL DATA SETS IN 4759 03:33:08,173 --> 03:33:08,506 THE WORLD. 4760 03:33:08,506 --> 03:33:11,643 WE HAVE DATA ON MORE THAN 51,000 4761 03:33:11,643 --> 03:33:14,579 PARTICIPANTS WITH UP TO 19 YEARS 4762 03:33:14,579 --> 03:33:17,182 OF DATA ON SOME. 4763 03:33:17,182 --> 03:33:19,417 THIS INCLUDES PARTICIPANTS 4764 03:33:19,417 --> 03:33:21,653 HEALTHY, AT RISK AND WITH 4765 03:33:21,653 --> 03:33:22,621 DEMENTIA SYSTEMS. 4766 03:33:22,621 --> 03:33:25,957 THE UNIFORM DATA SET WHICH HAS 4767 03:33:25,957 --> 03:33:28,727 COLLECTED WITH ADRC SINCE 2005 4768 03:33:28,727 --> 03:33:32,330 IS STANDARDIZED AND LONGITUDINAL 4769 03:33:32,330 --> 03:33:34,699 AND CONSISTS OF ROBUST CRITERIA 4770 03:33:34,699 --> 03:33:36,735 BASED DIAGNOSES CONSIDERED GOLD 4771 03:33:36,735 --> 03:33:41,740 STANDARD BY THE FIELD. 4772 03:33:41,740 --> 03:33:43,808 IT HOUSES NEURAL PATHOLOGY DATA. 4773 03:33:43,808 --> 03:33:47,812 60% OF PARTICIPANTS ARE BRAIN 4774 03:33:47,812 --> 03:33:50,582 DONORS WITH PURE AND MIXED 4775 03:33:50,582 --> 03:33:50,982 ETIOLOGY. 4776 03:33:50,982 --> 03:33:53,718 IT HAS ENABLED MAJOR 4777 03:33:53,718 --> 03:33:54,386 BREAKTHROUGHS IN THE FIELD AND 4778 03:33:54,386 --> 03:33:58,023 USED TO GENERATE OVER 1300 4779 03:33:58,023 --> 03:33:58,957 PUBLICATIONS TO DATE. 4780 03:33:58,957 --> 03:34:00,959 ADDITIONALLY OVER THE PAST THREE 4781 03:34:00,959 --> 03:34:03,028 YEARS THREES BEEN OVER 100% 4782 03:34:03,028 --> 03:34:04,062 INCREASE IN THE AVERAGE NUMBER 4783 03:34:04,062 --> 03:34:07,999 OF DATA REQUESTS PER MONTH. 4784 03:34:07,999 --> 03:34:13,338 WE'RE NOW AT MORE THAN 100. 4785 03:34:13,338 --> 03:34:16,775 MUCH OF THE DATA IS STANDARDIZED 4786 03:34:16,775 --> 03:34:20,512 AND THERE'S DATA DRIVEN STANDARD 4787 03:34:20,512 --> 03:34:22,914 ALIGNED WITH THE DEVELOPMENTS. 4788 03:34:22,914 --> 03:34:24,683 THE LATEST VERSION WILL NOW 4789 03:34:24,683 --> 03:34:26,851 CAPTURE DATA ON USE OF DISEASE 4790 03:34:26,851 --> 03:34:28,553 MODIFYING DRUGS, SOCIAL 4791 03:34:28,553 --> 03:34:30,689 DETERMINATES OF HEALTH AND MILD 4792 03:34:30,689 --> 03:34:32,257 BEHAVIORAL IMPAIRMENT, 4793 03:34:32,257 --> 03:34:36,428 BIOMARKERS AND DIGITAL VOICE 4794 03:34:36,428 --> 03:34:36,728 RECORDINGS. 4795 03:34:36,728 --> 03:34:38,697 OUR CURRENT TOOLS HAVE BEEN 4796 03:34:38,697 --> 03:34:42,167 TRANSLATED INTO OVER 32 4797 03:34:42,167 --> 03:34:43,368 LANGUAGES AND USED IN 140 4798 03:34:43,368 --> 03:34:44,736 INTERNATIONAL RESEARCH STUDIES 4799 03:34:44,736 --> 03:34:47,372 OVER THE PAST FIVE YEARS. 4800 03:34:47,372 --> 03:34:48,773 TO FURTHER EMPOWER THE RESEARCH 4801 03:34:48,773 --> 03:34:52,177 COMMUNITY TO TACKLE THE MOST 4802 03:34:52,177 --> 03:34:53,545 COMPLEX AND PRESSING CHALLENGES 4803 03:34:53,545 --> 03:34:55,714 WE'VE ESTABLISHED A ONE STOP 4804 03:34:55,714 --> 03:34:57,449 SHOP FOR PARTICIPANT DATA. 4805 03:34:57,449 --> 03:35:01,519 THE FLEXIBLE AND MODERN CLOUD 4806 03:35:01,519 --> 03:35:04,456 BASED DATA PLATFORM IS MORE 4807 03:35:04,456 --> 03:35:05,957 MULTI-MODAL AND INTEROPERABLE 4808 03:35:05,957 --> 03:35:08,727 AND PROVIDES EASY ACCESS TO 4809 03:35:08,727 --> 03:35:10,929 INCREASING QUANTITIES OF DATA 4810 03:35:10,929 --> 03:35:13,264 STANDARDIZED AND HARMONIZED AND 4811 03:35:13,264 --> 03:35:13,698 INTEGRATE. 4812 03:35:13,698 --> 03:35:17,502 GO TO NACC DATA DOT ORG TO LEARN 4813 03:35:17,502 --> 03:35:18,403 MORE. 4814 03:35:18,403 --> 03:35:24,376 WE MIGRATED OUR EXISTING DATA 4815 03:35:24,376 --> 03:35:25,577 PLATFORM WITH PET DATA. 4816 03:35:25,577 --> 03:35:27,679 WE'RE ALSO IN THE PROCESS OF 4817 03:35:27,679 --> 03:35:30,281 BUILDING OUT NEW PIPELINES TO 4818 03:35:30,281 --> 03:35:33,818 INTEGRATE DIGITAL DATA AND 4819 03:35:33,818 --> 03:35:35,754 BIOMARKERS AND E.H.R. AND CLAIMS 4820 03:35:35,754 --> 03:35:37,222 DATA. 4821 03:35:37,222 --> 03:35:41,226 WE'RE EXPANDING INTEROPERABILITY 4822 03:35:41,226 --> 03:35:47,966 TO INTEGRATE MORE MODALITIES. 4823 03:35:47,966 --> 03:35:52,737 SO FAR INCLUDES FLUID DATA AND 4824 03:35:52,737 --> 03:35:54,873 MULTIOMICS DATA. 4825 03:35:54,873 --> 03:35:57,308 LASTLY, IT'S PROVIDING THE 4826 03:35:57,308 --> 03:35:59,210 INFORMATICS AND INFRASTRUCTURE 4827 03:35:59,210 --> 03:36:02,647 TO ENABLE MAJOR CROSS PROGRAM 4828 03:36:02,647 --> 03:36:05,016 INITIATIVES SUCH AS SCAN AND 4829 03:36:05,016 --> 03:36:05,316 CLARITY. 4830 03:36:05,316 --> 03:36:07,719 THIS TOO HAS MADE DATA STREAMS 4831 03:36:07,719 --> 03:36:10,055 AVAILABLE INCLUDING AT 4832 03:36:10,055 --> 03:36:15,827 STANDARDIZED MRI AND PET, FLUID 4833 03:36:15,827 --> 03:36:17,262 BIOMARKER AND IT WILL SERVE AS A 4834 03:36:17,262 --> 03:36:21,666 ONE STOP SHOP FOR RESEARCHERS TO 4835 03:36:21,666 --> 03:36:23,368 SEARCH, VISUALIZE ALL MODALITIES 4836 03:36:23,368 --> 03:36:26,104 FOR PARTICIPANTS ACROSS 4837 03:36:26,104 --> 03:36:26,438 REPOSITORIES. 4838 03:36:26,438 --> 03:36:29,307 THE DATA FRONT DOOR SELF-SERVICE 4839 03:36:29,307 --> 03:36:30,942 COMPONENTS INCLUDE QUICK ACCESS 4840 03:36:30,942 --> 03:36:34,012 FILES, REAL TIME DASH BOARDS AND 4841 03:36:34,012 --> 03:36:36,147 SELECTION TOOL FOR BUILDING DATA 4842 03:36:36,147 --> 03:36:36,714 SETS. 4843 03:36:36,714 --> 03:36:39,651 WE'RE ALSO PILOTING A SECURE 4844 03:36:39,651 --> 03:36:41,086 ENVIRONMENT WITH THE LINKAGE 4845 03:36:41,086 --> 03:36:41,820 PLATFORM. 4846 03:36:41,820 --> 03:36:45,390 OUR QUICK ACCESS FILE ENABLES 4847 03:36:45,390 --> 03:36:47,092 RESEARCHERS TO ACCESS DATA 4848 03:36:47,092 --> 03:36:48,726 WITHIN 24 HOURS BY SIGNING A 4849 03:36:48,726 --> 03:36:49,794 DATA USE AGREEMENT AND 4850 03:36:49,794 --> 03:36:52,397 SUBMITTING A 15-MINUTE DATA 4851 03:36:52,397 --> 03:36:52,730 REQUEST. 4852 03:36:52,730 --> 03:36:56,134 IT PROVIDES REAL TIME 4853 03:36:56,134 --> 03:36:57,535 INFORMATION HOW MUCH MRI AND PET 4854 03:36:57,535 --> 03:36:59,537 DATA IS AVAILABLE. 4855 03:36:59,537 --> 03:37:01,439 OUR NEW NEW SECURE ENCLAVE 4856 03:37:01,439 --> 03:37:03,675 ENABLES RESEARCHERS PART OF OUR 4857 03:37:03,675 --> 03:37:07,679 PILOT STUDY TO ANALYZE E.H.R. 4858 03:37:07,679 --> 03:37:10,849 AND CLAIMS DATA FROM CONCEPTS 4859 03:37:10,849 --> 03:37:12,250 PARTICIPANTS. 4860 03:37:12,250 --> 03:37:13,418 OUR COHORT BROWSER TOOL ONLINE 4861 03:37:13,418 --> 03:37:16,221 IN THE NEXT YEAR WILL ENABLE 4862 03:37:16,221 --> 03:37:17,956 RESEARCHERS TO BUILD THEIR OWN 4863 03:37:17,956 --> 03:37:19,924 MULTI-MODAL DATA SETS WITH 4864 03:37:19,924 --> 03:37:21,292 PARTICIPANT DATA AVAILABLE ON 4865 03:37:21,292 --> 03:37:23,161 THE PLATFORM OR PARTNER 4866 03:37:23,161 --> 03:37:23,995 REPOSITORIES. 4867 03:37:23,995 --> 03:37:27,198 WE EXPECT MAKING ALL THESE DATA 4868 03:37:27,198 --> 03:37:28,466 MODALITIES AVAILABLE FOR THE 4869 03:37:28,466 --> 03:37:29,901 PARTICIPANTS WILL EMPOWER 4870 03:37:29,901 --> 03:37:30,935 RESEARCHERS TO ANSWER NEW 4871 03:37:30,935 --> 03:37:36,741 QUESTIONS TO ADVANCE THE FIELD. 4872 03:37:36,741 --> 03:37:39,244 AND DE-UTILIZATION. 4873 03:37:39,244 --> 03:37:41,746 WE'RE TALKING NEARLY 20,000 4874 03:37:41,746 --> 03:37:42,480 PARTICIPANTS WITH MORE THAN 12 4875 03:37:42,480 --> 03:37:45,150 DATA TYPES AVAILABLE FOR EACH. 4876 03:37:45,150 --> 03:37:48,019 I'M ALSO SXIETED TO SHARE HOW WE 4877 03:37:48,019 --> 03:37:49,787 PLAN TO FURTHER LEVERAGE DATA TO 4878 03:37:49,787 --> 03:37:50,655 DRIVE DISCOVERY AND TRANSLATION 4879 03:37:50,655 --> 03:37:54,425 AS PART OF OUR RENEWAL 4880 03:37:54,425 --> 03:37:54,726 APPLICATION. 4881 03:37:54,726 --> 03:37:55,860 WE'LL LAUNCH A RESEARCH 4882 03:37:55,860 --> 03:37:58,196 NAVIGATOR TEAM TO SUPPORT 4883 03:37:58,196 --> 03:38:00,732 RESEARCHERS IN MATCHING THE DATA 4884 03:38:00,732 --> 03:38:02,567 TO QUESTIONS AND PROVIDER 4885 03:38:02,567 --> 03:38:04,736 ONRAMPS TO RESPONSIBLE A.I. 4886 03:38:04,736 --> 03:38:06,871 WE'LL FACILITATE COMPUTATIONAL 4887 03:38:06,871 --> 03:38:09,674 ANALYSIS BY PROVIDING A SECURE 4888 03:38:09,674 --> 03:38:11,609 ENVIRONMENT EQUIPPED WITH BUILT 4889 03:38:11,609 --> 03:38:13,611 IN TOOLS LIKE JUPYTER NOTEBOOKS 4890 03:38:13,611 --> 03:38:15,880 AND GPUs AVAILABLE TO DEVELOP 4891 03:38:15,880 --> 03:38:20,618 AND TEST ALGORITHMS TO 4892 03:38:20,618 --> 03:38:22,086 SUBSIDIZED FEE FOR SERVICE MOLE 4893 03:38:22,086 --> 03:38:25,356 AND THE ENCLAVE WILL ENABLE 4894 03:38:25,356 --> 03:38:26,558 DISCOVERIES THROUGH 4895 03:38:26,558 --> 03:38:27,692 COLLABORATION WITH PARTNERS AND 4896 03:38:27,692 --> 03:38:29,427 GATE VENTURES AND CATTLE AND 4897 03:38:29,427 --> 03:38:31,229 SAGE BIO NETWORKS. 4898 03:38:31,229 --> 03:38:36,167 TO SUPPORT TRANSPARENT, 4899 03:38:36,167 --> 03:38:38,336 RESPONSIBLE AND EXPLAINABLE 4900 03:38:38,336 --> 03:38:40,405 RESEARCH IT WILL PARTNER TO HAVE 4901 03:38:40,405 --> 03:38:44,108 AN OPEN REPOSITORY OF A.I. 4902 03:38:44,108 --> 03:38:44,409 ALGORITHMS. 4903 03:38:44,409 --> 03:38:46,244 IT WILL ENABLE THE RESEARCH 4904 03:38:46,244 --> 03:38:50,682 COMMUNITY TO VALIDATE ALGORITHMS 4905 03:38:50,682 --> 03:38:54,552 CONDUCT DEEPER MULE TIE MODEL 4906 03:38:54,552 --> 03:38:56,754 ANALYSIS AND TEST DIFFERENT 4907 03:38:56,754 --> 03:38:58,756 POPULATIONS AN SAVE RESOURCES BY 4908 03:38:58,756 --> 03:39:00,225 ENABLING RESEARCHERS TO BUILD 4909 03:39:00,225 --> 03:39:02,460 OFF EACH OTHER TOOLS RATHER THAN 4910 03:39:02,460 --> 03:39:03,695 RECREATING THE WHEEL. 4911 03:39:03,695 --> 03:39:05,863 WE HOPE THESE INITIATIVES WILL 4912 03:39:05,863 --> 03:39:07,565 FURTHER DEMOCRATIZE AND BUILD 4913 03:39:07,565 --> 03:39:08,199 TRUST IN THE RESEARCH. 4914 03:39:08,199 --> 03:39:10,168 >> THANK YOU. 4915 03:39:10,168 --> 03:39:15,673 OUR NEXT SPEAKER IS ANDY SAKIN 4916 03:39:15,673 --> 03:39:19,544 FROM INDIANA UNIVERSITY. 4917 03:39:19,544 --> 03:39:21,145 >> WE'VE BEEN HEARING ABOUT A 4918 03:39:21,145 --> 03:39:23,114 TREMENDOUS VOLUME OF DATA FOR 4919 03:39:23,114 --> 03:39:25,683 TWO AND A HALF DAYS ESPECIALLY 4920 03:39:25,683 --> 03:39:27,385 IN THIS SESSION. 4921 03:39:27,385 --> 03:39:28,219 JUST EXTRAORDINARY. 4922 03:39:28,219 --> 03:39:30,154 IT USED TO BE WHAT MY COLLEAGUE 4923 03:39:30,154 --> 03:39:35,226 CALLED DATA PENIA AND HAVE RAIN 4924 03:39:35,226 --> 03:39:37,328 EXPLOSION OF EXTREMELY VALUABLE 4925 03:39:37,328 --> 03:39:37,528 DATA. 4926 03:39:37,528 --> 03:39:39,697 HOW DO WE ANALYZE AND EXTRACT 4927 03:39:39,697 --> 03:39:41,599 THE IMPORTANT INFORMATION FROM 4928 03:39:41,599 --> 03:39:43,901 THIS COMPLEX MATRIX? 4929 03:39:43,901 --> 03:39:46,537 HOW DO WE PUT CUTTING PLANES TO 4930 03:39:46,537 --> 03:39:48,740 THE HAIR BALL OF THE 4931 03:39:48,740 --> 03:39:52,744 CONNECTIVITY OF THE DATA 4932 03:39:52,744 --> 03:39:53,845 DIFFERENT SETS? 4933 03:39:53,845 --> 03:39:56,147 ONE IMPORTANT PROGRAM TRYING TO 4934 03:39:56,147 --> 03:39:57,115 BRING ADVANCED ANALYTIC 4935 03:39:57,115 --> 03:40:00,718 STRATEGIES TO THE FIELD IS A.I. 4936 03:40:00,718 --> 03:40:03,454 AND MACHINE LEARNING CONSORTIUM. 4937 03:40:03,454 --> 03:40:05,757 I MENTIONED GIVING A TELEGRAPHIC 4938 03:40:05,757 --> 03:40:07,725 DESCRIPTION OF THE GENETICS 4939 03:40:07,725 --> 03:40:12,497 INITIATIVES ON MONDAY, THAT WAS 4940 03:40:12,497 --> 03:40:14,299 ADDED LATER IN THE GAME OF 2021. 4941 03:40:14,299 --> 03:40:16,167 THE FIRST TWO PROJECTS AND 4942 03:40:16,167 --> 03:40:17,235 THERE'S A LIST IN THE UPPER 4943 03:40:17,235 --> 03:40:20,738 CORNER OF THE EIGHT PROGRAMS 4944 03:40:20,738 --> 03:40:22,340 FUNNED THROUGH THE INITIATIVE. 4945 03:40:22,340 --> 03:40:25,043 THE FIRST TWO INCLUDING WHAT WE 4946 03:40:25,043 --> 03:40:28,079 CALL A.I. FOR AD CONSORTIUM WITH 4947 03:40:28,079 --> 03:40:32,950 FIVE P.I.s AND MANY OTHER 4948 03:40:32,950 --> 03:40:35,086 INVESTIGATORS WAS FUNDED AND 4949 03:40:35,086 --> 03:40:35,687 ANOTHER AND SIX ADDITIONAL 4950 03:40:35,687 --> 03:40:41,826 JOINED A YEAR LATER. 4951 03:40:41,826 --> 03:40:45,330 WITH HAVE REGULAR MEETINGS AND 4952 03:40:45,330 --> 03:40:46,431 DO DATA SHARING CROSS GROUPS 4953 03:40:46,431 --> 03:40:46,964 WHICH HAS BEEN EXCITING. 4954 03:40:46,964 --> 03:40:52,704 I WANTED TO GIVE A FEEL FOR SOME 4955 03:40:52,704 --> 03:40:55,106 OF THE WORK GOING ON. 4956 03:40:55,106 --> 03:41:00,745 ONE OF THE MAJOR FOES DID BE 4957 03:41:00,745 --> 03:41:05,817 FOSI IS THE IMAGING AND FLUID 4958 03:41:05,817 --> 03:41:08,186 BIOMARKERS AND SO ON. 4959 03:41:08,186 --> 03:41:10,988 THE CONSORTIUM FOR PHENOTYPE 4960 03:41:10,988 --> 03:41:12,657 HARMONIZATION CAME A YEAR INTO 4961 03:41:12,657 --> 03:41:12,857 THIS. 4962 03:41:12,857 --> 03:41:18,930 WE HAD TO START AND DO SOME OF 4963 03:41:18,930 --> 03:41:22,400 THIS WITHIN A.I. M.L. AND DO 4964 03:41:22,400 --> 03:41:30,341 THIS ON A LARGE SCALE BASIS. 4965 03:41:30,341 --> 03:41:35,413 TAKING IMAGE WE CAN USE DEEP 4966 03:41:35,413 --> 03:41:37,215 LEARNING APPROACHES AND ASK THE 4967 03:41:37,215 --> 03:41:39,684 INFORMATIVE FEATURES AND DOING 4968 03:41:39,684 --> 03:41:42,620 GROUP ANALYSES AND VARIOUS 4969 03:41:42,620 --> 03:41:44,055 STRATEGIES BUT NOW WE HAVE OTHER 4970 03:41:44,055 --> 03:41:46,858 TOOLS THAT COULD TELL US WHAT 4971 03:41:46,858 --> 03:41:48,659 FEATURES MAY BE MAXIMALLY INFORM 4972 03:41:48,659 --> 03:41:51,896 AND MAY SERVE AS BETTER 4973 03:41:51,896 --> 03:41:52,997 PHENOTYPES FOR CLINICAL TRIALS 4974 03:41:52,997 --> 03:41:55,166 AND SO ON. 4975 03:41:55,166 --> 03:41:59,203 IN THE UPPER RIGHT IS AN EXAMPLE 4976 03:41:59,203 --> 03:42:00,805 OF ANALYSIS OF TAU PET BY DEEP 4977 03:42:00,805 --> 03:42:07,745 LEARNING AT INDIANA UNIVERSITY. 4978 03:42:07,745 --> 03:42:10,615 THE LOWER IMAGE SHOWS A 4979 03:42:10,615 --> 03:42:11,282 CONVENTIONAL GROUP ANALYSIS WITH 4980 03:42:11,282 --> 03:42:11,883 TAU PET. 4981 03:42:11,883 --> 03:42:15,653 THE UPPER IMAGE IS WHAT A DEEP 4982 03:42:15,653 --> 03:42:18,055 LEARNING ALGORITHM IDENTIFIES AS 4983 03:42:18,055 --> 03:42:22,994 THE MOST INFORMATIVE FEATURE 4984 03:42:22,994 --> 03:42:26,697 AREA AROUND THE INTER-RHINAL 4985 03:42:26,697 --> 03:42:30,134 CORTEX AND MAY BE A BETTER 4986 03:42:30,134 --> 03:42:32,737 PHENOTYPE. 4987 03:42:32,737 --> 03:42:35,239 WE HAVE 3 BILLION BASE CARES OF 4988 03:42:35,239 --> 03:42:39,277 PAIRS IN THE GENOME AND 60,000 4989 03:42:39,277 --> 03:42:41,045 GENOMES BY THE RELEASE THIS YEAR 4990 03:42:41,045 --> 03:42:42,780 AND ANOTHER 80,000 THE YEAR 4991 03:42:42,780 --> 03:42:42,980 AFTER. 4992 03:42:42,980 --> 03:42:46,384 HOW DO WE INTERROGATE 3 BILLION 4993 03:42:46,384 --> 03:42:48,920 BASES TIMES 80,000 INDIVIDUALS 4994 03:42:48,920 --> 03:42:54,392 OR MORE AGGREGATING DATA FROM 4995 03:42:54,392 --> 03:42:55,760 U.K. BIO BANK AND OTHER 4996 03:42:55,760 --> 03:42:57,161 SEQUENCING SOURCES? 4997 03:42:57,161 --> 03:42:59,530 ONE WAY IS TO USE DEEP LEARNING 4998 03:42:59,530 --> 03:43:01,399 APPROACHES OR LARGE LANGUAGE 4999 03:43:01,399 --> 03:43:02,967 MODEL STRATEGIES. 5000 03:43:02,967 --> 03:43:04,735 ONE EXAMPLE SHOWN IN THE LOWER 5001 03:43:04,735 --> 03:43:08,739 LEFT PANEL WAS SOMETHING WE 5002 03:43:08,739 --> 03:43:11,409 CALLED SWAT CNN A SLIDING WINDOW 5003 03:43:11,409 --> 03:43:16,547 THROUGH THE GENOME AND DOES 5004 03:43:16,547 --> 03:43:18,216 CONVOLUTIONAL ANALYSIS TO FIND 5005 03:43:18,216 --> 03:43:18,850 INFORMATIVE FEATURES AND GETTING 5006 03:43:18,850 --> 03:43:26,991 COMPARED TO THE 5007 03:43:26,991 --> 03:43:27,158 AT 5008 03:43:27,158 --> 03:43:28,292 UNIVERSITY OF PENNSYLVANIA 5009 03:43:28,292 --> 03:43:30,061 STUDY PUBLISHED IN NATURE 5010 03:43:30,061 --> 03:43:31,562 COMMUNICATIONS EARLIER THIS 5011 03:43:31,562 --> 03:43:34,198 YEAR BY YAN ET AL, LOOKED AT 5012 03:43:34,198 --> 03:43:38,369 MRI FROM 28,000 INDIVIDUALS 5013 03:43:38,369 --> 03:43:43,307 AND LOOKED FOR MOLECULAR 5014 03:43:43,307 --> 03:43:46,410 SUBTYPES, MORPHOLOGIC 5015 03:43:46,410 --> 03:43:48,045 SUBTYPES MAXIMALLY 5016 03:43:48,045 --> 03:43:50,715 ASSOCIATED WITH GENETIC DATA 5017 03:43:50,715 --> 03:43:52,617 AND FOUND FOUR SUBTYPES. 5018 03:43:52,617 --> 03:43:54,619 THERE'S MANY WAYS TO SLIGHTS 5019 03:43:54,619 --> 03:43:56,921 THEM UP, WE NEED TO FIND THE 5020 03:43:56,921 --> 03:43:58,222 MOST ACTIONABLE AS WE TALKED 5021 03:43:58,222 --> 03:43:59,290 ABOUT MONDAY. THIS IS A 5022 03:43:59,290 --> 03:44:01,592 STRATEGY FOR EXTRACTING THE 5023 03:44:01,592 --> 03:44:02,760 INFORMATIVE INFORMATION FROM 5024 03:44:02,760 --> 03:44:03,995 VERY LARGE VERY HIGH 5025 03:44:03,995 --> 03:44:06,397 DIMENSIONAL DATA SETS. AND 5026 03:44:06,397 --> 03:44:08,566 WE'LL HAVE MUCH PROMISE. ONE 5027 03:44:08,566 --> 03:44:09,567 IMPORTANT PRINCIPLE THOUGH 5028 03:44:09,567 --> 03:44:11,068 IS WE CAN'T JUST RUN THIS AS 5029 03:44:11,068 --> 03:44:12,203 A BLACK BOX THROW THINGS 5030 03:44:12,203 --> 03:44:13,804 INTO THE HOPPER AND SEE WHAT 5031 03:44:13,804 --> 03:44:16,374 COMES OUT OF THE OTHER END 5032 03:44:16,374 --> 03:44:17,675 AND WHAT ARE THESE 5033 03:44:17,675 --> 03:44:19,410 MULTI-LAYERED NETWORK ANAL 5034 03:44:19,410 --> 03:44:20,478 SEE. WE NEED TO UNDERSTAND 5035 03:44:20,478 --> 03:44:22,213 WHY THEY, WHO. IF I FINDS A 5036 03:44:22,213 --> 03:44:24,115 DRUG TARGET WHICH IS DRUG 5037 03:44:24,115 --> 03:44:26,117 REPURPOSING TARGET ONE OF 5038 03:44:26,117 --> 03:44:27,351 THE STRATEGIES THAT 5039 03:44:27,351 --> 03:44:28,786 (INDISCERNIBLE) IS LEADING 5040 03:44:28,786 --> 03:44:29,287 FOR THE GROUP OR FINDS 5041 03:44:29,287 --> 03:44:32,657 INFORMATIVE REGION, OR A NEW 5042 03:44:32,657 --> 03:44:34,125 GENETIC LOCI THAT'S 5043 03:44:34,125 --> 03:44:34,959 DETECTED, WE HAVE TO 5044 03:44:34,959 --> 03:44:36,460 UNDERSTAND WHY IT WORKS. SO 5045 03:44:36,460 --> 03:44:38,729 WE NEED MAXIMALLY 5046 03:44:38,729 --> 03:44:40,197 INFORMATIVE OPEN STRATEGIES 5047 03:44:40,197 --> 03:44:42,199 FOR THAT. THAT'S A MAJOR 5048 03:44:42,199 --> 03:44:44,101 PRINCIPLE FOR THE GROUP. I 5049 03:44:44,101 --> 03:44:46,370 WILL STOP THERE. BUT I THINK 5050 03:44:46,370 --> 03:44:47,805 YOU CAN SEE THE POTENTIAL 5051 03:44:47,805 --> 03:44:50,207 PROMISE OF THESE APPROACHES 5052 03:44:50,207 --> 03:44:51,576 AND CONSORTIUMS. 5053 03:44:51,576 --> 03:44:55,246 >> THANK YOU, DR. SAYKIN. OUR 5054 03:44:55,246 --> 03:44:59,116 NEXT SPEAKER IS DR. EUGENE 5055 03:44:59,116 --> 03:45:03,120 HINDERER FROM TUFTS UNIVERSITY. 5056 03:45:03,120 --> 03:45:06,691 >> THANKS. GOOD AFTERNOON. MY 5057 03:45:06,691 --> 03:45:08,826 NAME IS EUGENE HINDERER, FROM 5058 03:45:08,826 --> 03:45:11,095 TUFTS CLINICAL AND TRANSLATIONAL 5059 03:45:11,095 --> 03:45:13,264 SCIENCE INSTITUTE. SINCE 2019 5060 03:45:13,264 --> 03:45:15,166 OUR TEAM HAS BEEN HARD AT WORK 5061 03:45:15,166 --> 03:45:17,335 DEVELOPING TAP DISCOVERY. AI 5062 03:45:17,335 --> 03:45:18,803 PLACED PLATFORM FOR MULTI-SCALE 5063 03:45:18,803 --> 03:45:20,471 CLINICAL AND LABORATORY DATA 5064 03:45:20,471 --> 03:45:22,707 ANALYSIS, AUTOMATED DATA MINING, 5065 03:45:22,707 --> 03:45:24,809 AND KNOWLEDGE ENHANCED MACHINE 5066 03:45:24,809 --> 03:45:26,877 LEARNING. OUR AIM IS TO PROVIDE 5067 03:45:26,877 --> 03:45:28,446 ACADEMIC RESEARCHERS WITH 5068 03:45:28,446 --> 03:45:30,014 COMMERCIAL GRADE TOOLS AN 5069 03:45:30,014 --> 03:45:31,449 INNOVATIVE INFRASTRUCTURE TO 5070 03:45:31,449 --> 03:45:34,218 ACCELERATE RESEARCH AND CREATE 5071 03:45:34,218 --> 03:45:36,687 ACTIONABLE METRICAL DISCOVERIES. 5072 03:45:36,687 --> 03:45:38,990 FIRST AND MOST MOW WE DESIGNED 5073 03:45:38,990 --> 03:45:40,324 AN OPEN SCIENCE PLATFORM WITH 5074 03:45:40,324 --> 03:45:43,094 FEATURES AND PERFORMANCE OF 5075 03:45:43,094 --> 03:45:44,528 COMMERCIAL GRADE INFORMATICS 5076 03:45:44,528 --> 03:45:46,864 SYSTEM. TO NAME MANY KEY ASPECTS 5077 03:45:46,864 --> 03:45:48,733 OF THIS PLATFORM FIRST IT IS 5078 03:45:48,733 --> 03:45:51,569 DESIGNED FOR ALL TYPES OF U 5079 03:45:51,569 --> 03:45:52,903 CRUISERS FROM CLINICS EYE 5080 03:45:52,903 --> 03:45:54,472 BIOLOGISTS TO CHEMISTS. T IT 5081 03:45:54,472 --> 03:45:56,107 INCLUDES SEAMLESS ACTS IS TO 5082 03:45:56,107 --> 03:45:57,341 BILLIONS OF KNOWLEDGE 5083 03:45:57,341 --> 03:45:58,876 ASSOCIATIONS FOR USER IN YOUR 5084 03:45:58,876 --> 03:46:02,079 MODELS, CONTAINS DATA RANGELING 5085 03:46:02,079 --> 03:46:03,180 TOOLS WITH INTERNAL CALL CHECKS, 5086 03:46:03,180 --> 03:46:04,815 USE BEST IN CLASS MACHINE 5087 03:46:04,815 --> 03:46:09,220 LEARNING MODELS TO HANDLE 5088 03:46:09,220 --> 03:46:11,722 MULTI-SCALE CLINICAL OMIC AND 5089 03:46:11,722 --> 03:46:13,691 IMAGING DATA USED TOGETHER IN A 5090 03:46:13,691 --> 03:46:17,028 MODEL THAT GOES BEYONDS COMMON 5091 03:46:17,028 --> 03:46:19,563 MACHINE LEARNING ALGORITHMS TO 5092 03:46:19,563 --> 03:46:20,965 ADAPT WORKLOADS AND MILLION 5093 03:46:20,965 --> 03:46:23,300 SCALE REASONING. ALLOWING DATA 5094 03:46:23,300 --> 03:46:27,505 DRIVEN MULTI-SCALE ANALYTICS AND 5095 03:46:27,505 --> 03:46:29,974 BIOMEMECAL INFORMATICS IN ONE 5096 03:46:29,974 --> 03:46:32,543 DISCOVERY. WHAT WE CALL THE 5097 03:46:32,543 --> 03:46:35,646 VIRTUOUS LOOP AT TOP RIGHT. TAP 5098 03:46:35,646 --> 03:46:37,982 DISCOVERY ALSO SAVES WORKLOADS 5099 03:46:37,982 --> 03:46:39,717 TO USE WITH EXISTING DATA SETS 5100 03:46:39,717 --> 03:46:41,385 FOR REPRODUCIBILITY AND NEW DATA 5101 03:46:41,385 --> 03:46:42,386 SETS FOR EXPERIMENTAL 5102 03:46:42,386 --> 03:46:44,789 CONSISTENCY. TO SHARE WITH 5103 03:46:44,789 --> 03:46:47,091 COLLABORATORS. EVERYTHING TO 5104 03:46:47,091 --> 03:46:47,725 REINFORCE BEST SCIENTIFIC 5105 03:46:47,725 --> 03:46:49,827 PRACTICES. FOR ADVANCED 5106 03:46:49,827 --> 03:46:52,630 ANALYSIS, A PLATFORM INCLUDES 5107 03:46:52,630 --> 03:46:53,931 INTEGRATED EXMANGE AI METHODS, 5108 03:46:53,931 --> 03:46:55,900 WHAT IF SCREENS AND AUTOED MATED 5109 03:46:55,900 --> 03:46:58,002 RURAL GENERATOR ON COUNTER 5110 03:46:58,002 --> 03:47:00,671 FACTUALS. WE INCLUDED 5111 03:47:00,671 --> 03:47:01,338 BIOINFORMATICS INDIVIDUALS TO 5112 03:47:01,338 --> 03:47:03,541 ASSIST USER IN UNDERSTANDING AND 5113 03:47:03,541 --> 03:47:05,309 SHARING RESULTS 6789 DOMAIN 5114 03:47:05,309 --> 03:47:07,478 SPECIFIC TOOLS LIKE GENOME 5115 03:47:07,478 --> 03:47:10,047 BROWSERS, VIEWERS CHEMICAL EDIT 5116 03:47:10,047 --> 03:47:11,682 TORRS AND PATHWAY VISUALS. ALL 5117 03:47:11,682 --> 03:47:14,218 LIVE LINKERRED WITHIN ALL AI AND 5118 03:47:14,218 --> 03:47:16,454 ML RESULTS AND BIOCHEMICAL 5119 03:47:16,454 --> 03:47:18,355 INFORMATICS CAPABILITIES. IN 5120 03:47:18,355 --> 03:47:21,425 ADDITION, USER DEFINED KNOWLEDGE 5121 03:47:21,425 --> 03:47:23,227 GRAFTS SUPPORTED BY INTERNAL 5122 03:47:23,227 --> 03:47:24,562 KNOWLEDGE REPOSITORY OF OPEN 5123 03:47:24,562 --> 03:47:25,996 SCIENCE KNOWLEDGE HELP PLACE 5124 03:47:25,996 --> 03:47:27,031 RESULTS IN CONTEXT OF DISEASE 5125 03:47:27,031 --> 03:47:29,467 AND PHENOTYPES, PATHWAYS AND 5126 03:47:29,467 --> 03:47:30,601 HALLMARKS, AND ALL THE WAY DOWN 5127 03:47:30,601 --> 03:47:32,503 TO PROTEINS AND CHEMICALS AND 5128 03:47:32,503 --> 03:47:35,906 PROCESSES. THIS AGE 5129 03:47:35,906 --> 03:47:36,941 UNDERSTANDING GIVING NEXT STEPS 5130 03:47:36,941 --> 03:47:38,843 TO EXPLORATION TOWARDS NEW 5131 03:47:38,843 --> 03:47:40,177 DISCOVERIES. LASTLY, TWO 5132 03:47:40,177 --> 03:47:42,413 FEATURES THAT ARE ON THE HORIZON 5133 03:47:42,413 --> 03:47:44,582 BEFORE U OUR Q1 PUBLIC REELS 5134 03:47:44,582 --> 03:47:46,784 WILL INCLUDE ADDING POWERFUL LLM 5135 03:47:46,784 --> 03:47:48,519 CAPABILITIES TO FURTHER ENHANCE 5136 03:47:48,519 --> 03:47:49,987 EXPLANATION AND CONTEXT 5137 03:47:49,987 --> 03:47:52,490 BUILDING, AND FEATURES TO 5138 03:47:52,490 --> 03:47:53,424 AUTOMATICICALLY GENERATE METHOD 5139 03:47:53,424 --> 03:47:55,626 SECTION IN SUPPORTING FIGURES TO 5140 03:47:55,626 --> 03:47:58,662 ASSIST IN EASE OF PUBLICATIONS. 5141 03:47:58,662 --> 03:48:00,598 TO FULLY APPRECIATE TAP 5142 03:48:00,598 --> 03:48:01,832 DISCOVERIES CAPABILITIES I WANT 5143 03:48:01,832 --> 03:48:03,934 TO POINT OUT BUN OF OUR PILOT 5144 03:48:03,934 --> 03:48:05,402 PROJECTS, WHICH IDENTIFIED 5145 03:48:05,402 --> 03:48:06,537 POTENTIAL DRUG TARGETS 5146 03:48:06,537 --> 03:48:08,405 ASSOCIATED WITH SIGNIFICANT 5147 03:48:08,405 --> 03:48:09,106 COGNITIVE DECLINE IN 5148 03:48:09,106 --> 03:48:13,677 ALZHEIMERALZHEIMER'SDISEASE. WEA 5149 03:48:13,677 --> 03:48:19,483 FROM THE ROZ MAP STUDIES MOST 5150 03:48:19,483 --> 03:48:21,418 MODEM RNA SEQ DEMOGRAPHICS AND 5151 03:48:21,418 --> 03:48:23,921 COGNITIVE DECLINE ASSESSMENTS 5152 03:48:23,921 --> 03:48:26,056 FROM 146 INDIVIDUALS AND 5153 03:48:26,056 --> 03:48:28,025 CONTAINED OVER 56,000 FEATURE 5154 03:48:28,025 --> 03:48:28,559 VARIABLES. 5155 03:48:28,559 --> 03:48:31,562 WE TRAIN NINE MACHINE LEARNING 5156 03:48:31,562 --> 03:48:32,797 ALGORITHMS WITH HYPERFEATURE 5157 03:48:32,797 --> 03:48:35,232 OPTS MYIZATION WITH SELECTED 5158 03:48:35,232 --> 03:48:37,168 PREDICTIVE AND HIGH COGNITIVE 5159 03:48:37,168 --> 03:48:39,069 DECLINE AMONG SUBJECTS. WHILE WE 5160 03:48:39,069 --> 03:48:40,371 IDENTIFIED MANY DISEASE RELATED 5161 03:48:40,371 --> 03:48:41,705 FEATURES THE SYSTEM FLAGGED ONE 5162 03:48:41,705 --> 03:48:43,274 FEATURE CONSISTENTLY ACROSS THE 5163 03:48:43,274 --> 03:48:45,176 NINE MODELS WHICH WAS THE 5164 03:48:45,176 --> 03:48:48,479 EXPRESSION OF GENE CALLED 5165 03:48:48,479 --> 03:48:51,248 QUINNOID DIQDPR. MORE ON THAT IN 5166 03:48:51,248 --> 03:48:52,583 A MOMENT. USING THE PLATFORM 5167 03:48:52,583 --> 03:48:55,553 CAPABILITIES I MENTIONED 5168 03:48:55,553 --> 03:48:56,687 EARLIER, WE WERE ABLE TO 5169 03:48:56,687 --> 03:48:57,721 INVESTIGATE OUR RESULTS IN REAL 5170 03:48:57,721 --> 03:48:59,089 TIME RATHER THAN NEEDING TO END 5171 03:48:59,089 --> 03:49:00,891 THE STORY HERE OR MOVE TO 5172 03:49:00,891 --> 03:49:04,495 EXTERNAL TOOLS. USING OUR 5173 03:49:04,495 --> 03:49:07,698 MATHEMATICAL H H EQUIPOISE SCRE, 5174 03:49:07,698 --> 03:49:09,366 WE EXAMINE THE MODEL CONFIDENCE 5175 03:49:09,366 --> 03:49:10,835 AND PREDICTIONS ALLOWING US TO 5176 03:49:10,835 --> 03:49:12,970 UNDERSTAND THE ROBUSTNESS OF OUR 5177 03:49:12,970 --> 03:49:15,272 MODEL. WE USE PLATFORMS RURAL 5178 03:49:15,272 --> 03:49:17,174 GENERATOR FEATURE TO IDENTIFY 5179 03:49:17,174 --> 03:49:21,111 MINIMUM SET OF RULES BE MINIMUM 5180 03:49:21,111 --> 03:49:22,246 PERTURBATIONS TO CHANGE 5181 03:49:22,246 --> 03:49:23,581 PRETICKETED OUTCOMES. THE 5182 03:49:23,581 --> 03:49:25,449 CLINICAL OBSERVATION OF COG ANY 5183 03:49:25,449 --> 03:49:27,651 GIVE DECLINE. WE EXPLORED GENES 5184 03:49:27,651 --> 03:49:29,320 LIKE REQUEST,DPR, RELATE TO 5185 03:49:29,320 --> 03:49:31,222 KNOWN PHENOTYPES PATHWAYS SMALL 5186 03:49:31,222 --> 03:49:33,023 MOLECULE LIGANDS, USING OUR 5187 03:49:33,023 --> 03:49:34,658 KNOWLEDGE GRAPH TOOL, WHICH 5188 03:49:34,658 --> 03:49:36,994 GIVES US BETTER INSIGHT IN TO 5189 03:49:36,994 --> 03:49:39,096 POSSIBLE DISEASE MECHANISMS. 5190 03:49:39,096 --> 03:49:42,266 OUR NETWORK GRAPH ALLOWED TO 5191 03:49:42,266 --> 03:49:43,734 FURTHER VISUALIZE COMMONALITIES 5192 03:49:43,734 --> 03:49:45,402 AMONG SHARED GENE FEATURES, 5193 03:49:45,402 --> 03:49:46,637 CELLULAR LOCATION AND REGULATORY 5194 03:49:46,637 --> 03:49:48,973 PROCESSES. AND THIS IS CRITICAL 5195 03:49:48,973 --> 03:49:51,308 FOR ZEROING MECHANISMS AT PLAY 5196 03:49:51,308 --> 03:49:52,543 THAT INVOLVE OUR TARGET FEATURES 5197 03:49:52,543 --> 03:49:54,345 IN THE CONTEXT OF ALZHEIMER'S 5198 03:49:54,345 --> 03:49:57,648 PATHOLOGY. FINALLY, WE USE MANY 5199 03:49:57,648 --> 03:49:59,149 DOMAIN STANDARD BIOINFORMATICS 5200 03:49:59,149 --> 03:50:00,818 TOOLS INCLUDING A GENOME BROWSER 5201 03:50:00,818 --> 03:50:03,053 CHEMICAL VIEWER AND EDITOR AND 5202 03:50:03,053 --> 03:50:04,488 3-D PROTEIN VISUALIZER TO 5203 03:50:04,488 --> 03:50:05,689 FURTHER EXPLORE AND VET OUR 5204 03:50:05,689 --> 03:50:08,759 MODELS. CIRCLING BACK TO 5205 03:50:08,759 --> 03:50:10,561 IDENTIFICATION OF QDPR, WE WERE 5206 03:50:10,561 --> 03:50:12,263 ABLE TO USE THE TOOLS I JUST 5207 03:50:12,263 --> 03:50:14,231 DESCRIBED ALONG WITH THE 5208 03:50:14,231 --> 03:50:15,933 TRANSCRIPTOMICS MODEL OF AD TO 5209 03:50:15,933 --> 03:50:17,935 IMPLICATE KEY COMPONENTS OF THE 5210 03:50:17,935 --> 03:50:19,470 OXIDATIVE STRESS RESPONSE AND 5211 03:50:19,470 --> 03:50:20,471 MITOCHONDRIAL DYSFUNCTION AS 5212 03:50:20,471 --> 03:50:22,573 DRIVING FACTORS FOR OUR COG I 5213 03:50:22,573 --> 03:50:24,575 INTIVE DECLINE IN OUR MODEL. 5214 03:50:24,575 --> 03:50:26,010 PROMISINGLY A PARALLEL STUDY 5215 03:50:26,010 --> 03:50:28,112 CONNECTED BY MIT INVESTIGATING 5216 03:50:28,112 --> 03:50:29,313 SINGLE CELL TRANSCRIPT OMICS 5217 03:50:29,313 --> 03:50:32,783 USING THE SAME CORTAID FEWED 5218 03:50:32,783 --> 03:50:34,785 QDPR AS ONE OF FOUR GENES 5219 03:50:34,785 --> 03:50:35,886 EXPRESSION SIGNATURES 5220 03:50:35,886 --> 03:50:37,454 CONSISTENTLY DEFINED A 5221 03:50:37,454 --> 03:50:40,090 SUBPOPULATION OF PATHOLOGICAL 5222 03:50:40,090 --> 03:50:41,358 OLIGODENDROCYTES IN ALZHEIMER'S 5223 03:50:41,358 --> 03:50:43,794 POSITIVE SUBJECTS. SO TO 5224 03:50:43,794 --> 03:50:45,863 CONCLUDE, AS AI ENABLED 5225 03:50:45,863 --> 03:50:47,665 TECHNOLOGY IS LIKE TAP DISCOVERY 5226 03:50:47,665 --> 03:50:50,034 CONTINUE TO EVOLVE AND ENTER THE 5227 03:50:50,034 --> 03:50:51,302 MAINSTREAM, WE BELIEVE THEY WILL 5228 03:50:51,302 --> 03:50:53,370 DRIVE ACCELERATED INSIGHT AND 5229 03:50:53,370 --> 03:50:54,738 ACTIONABLE INFORMATION. WHAT WE 5230 03:50:54,738 --> 03:50:57,508 LIKE TO CALL AI 3. WE BELIEVE 5231 03:50:57,508 --> 03:50:59,276 TAP DISCOVERY IS A PIONEER IN 5232 03:50:59,276 --> 03:51:01,512 THIS REGARDS. AND WE PREPARE TO 5233 03:51:01,512 --> 03:51:03,080 GO LIVE -- I'M SORRY. WE INVITE 5234 03:51:03,080 --> 03:51:06,550 YOU TO JOIN US IN THIS CHART. 5235 03:51:06,550 --> 03:51:07,351 THANK YOU. 5236 03:51:07,351 --> 03:51:16,727 >> THANK YOU. SO NOW WE WOULD 5237 03:51:16,727 --> 03:51:20,130 LIKE TO DESCRIBE SOME OF THE 5238 03:51:20,130 --> 03:51:21,265 GAPS AND OPPORTUNITIES THIS 5239 03:51:21,265 --> 03:51:24,868 GROUP OF EXPERTS IDENTIFIED. SO 5240 03:51:24,868 --> 03:51:27,838 FIRST AND FOREMOST, WE DIVIDED 5241 03:51:27,838 --> 03:51:29,740 GAPS AND OPPORTUNITIES INTO 5242 03:51:29,740 --> 03:51:33,310 MULTIPLE DOMAINS. AND I THINK 5243 03:51:33,310 --> 03:51:35,846 THAT MANY OF THE TALKS ALREADY 5244 03:51:35,846 --> 03:51:37,181 TOUCHED ON SOME THESE ISSUES BUT 5245 03:51:37,181 --> 03:51:39,083 I WILL TAKE A MINUTE TO 5246 03:51:39,083 --> 03:51:40,718 HIGHLIGHT SOME OF THOSE ISSUES 5247 03:51:40,718 --> 03:51:43,387 THAT WERE DISCUSSED. SO IN THE 5248 03:51:43,387 --> 03:51:47,758 DOMAIN OF DATA DISCOVERY -- 5249 03:51:47,758 --> 03:51:48,759 DISCOVERABILITY INTEROPERABILITY 5250 03:51:48,759 --> 03:51:51,028 AND SUSTAINABILITY, WE 5251 03:51:51,028 --> 03:51:52,363 IDENTIFIED OPPORTUNITIES TO 5252 03:51:52,363 --> 03:51:56,200 IMPROVE THE FINDIBILITY OF DATA 5253 03:51:56,200 --> 03:51:59,136 SETS, TO ENCOURAGE 5254 03:51:59,136 --> 03:52:01,038 STANDARDIZATION OF BOTH DATA AND 5255 03:52:01,038 --> 03:52:02,806 METADATA. AS WELL AS TO 5256 03:52:02,806 --> 03:52:05,576 ENCOURAGE HARMONIZATION APPROACH 5257 03:52:05,576 --> 03:52:08,112 SUCH AS THOSE DECLINED BY DR. 5258 03:52:08,112 --> 03:52:11,115 HOHMAN. WE ALSO DISCUSSED 5259 03:52:11,115 --> 03:52:13,017 ESTABLISHING TECHNICAL 5260 03:52:13,017 --> 03:52:14,485 STANDARDS, THAT FOR DATA 5261 03:52:14,485 --> 03:52:16,887 FEDERATION, FEDERATED LEARNING, 5262 03:52:16,887 --> 03:52:19,223 AND DIGITAL TWINS TECHNOLOGIES. 5263 03:52:19,223 --> 03:52:24,061 AND FINALLY WE DISCUSSED THE 5264 03:52:24,061 --> 03:52:28,565 OPPORTUNITIES AVAILABLE TO 5265 03:52:28,565 --> 03:52:29,533 ENSURE DATA SHARING PROGRAMS ARE 5266 03:52:29,533 --> 03:52:32,002 SUSTAINABLE OVER THE LONG RUN BY 5267 03:52:32,002 --> 03:52:34,204 DEVELOPING FUNDING MODELS THAT 5268 03:52:34,204 --> 03:52:36,774 CAN SUPPORT DATA STORAGE 5269 03:52:36,774 --> 03:52:39,777 SECURITY AND CURATION. IN TERMS 5270 03:52:39,777 --> 03:52:42,246 OF DATA OPPORTUNITIES FOR DATA 5271 03:52:42,246 --> 03:52:45,582 DIGITAL DATA PLATFORMS THERE WAS 5272 03:52:45,582 --> 03:52:47,217 QUITE A BIT OF CONSIST CUSHION 5273 03:52:47,217 --> 03:52:49,019 ABOUT THE DIFFERENT MODELS THAT 5274 03:52:49,019 --> 03:52:50,888 ARE AVAILABLE AND INTEREST IN 5275 03:52:50,888 --> 03:52:52,656 SUPPORTING HYBRID DATA ACCESS 5276 03:52:52,656 --> 03:52:54,625 MODELS WHERE THEY MIGHT BE A 5277 03:52:54,625 --> 03:52:56,727 COMBINATION OF ENCLAVE APPROACH, 5278 03:52:56,727 --> 03:52:58,595 DOWNLOAD OR AGGRAVATED OR 5279 03:52:58,595 --> 03:53:01,398 FEDERATED APPROACHES. IN TERMS 5280 03:53:01,398 --> 03:53:03,934 OF THE OPPORTUNITIES AVAILABLE 5281 03:53:03,934 --> 03:53:05,736 FOR REAL WORLD DATA INTEGRATION 5282 03:53:05,736 --> 03:53:08,305 WITH SOME OF OUR COHORT DATA, 5283 03:53:08,305 --> 03:53:09,740 SOME OF THOSE OPPORTUNITIES 5284 03:53:09,740 --> 03:53:12,076 DESCRIBED BY DR. COREO IN HER 5285 03:53:12,076 --> 03:53:15,512 RELATION, WE DISCUSSED THE 5286 03:53:15,512 --> 03:53:18,115 OPPORTUNITIES AVAILABLE TO 5287 03:53:18,115 --> 03:53:19,817 INTEGRATE INFORMATION ABOUT THE 5288 03:53:19,817 --> 03:53:22,019 CLINICAL USE OF FIRST GENERATION 5289 03:53:22,019 --> 03:53:24,021 DISEASE MODIFYING THERAPIES FROM 5290 03:53:24,021 --> 03:53:26,690 NATIONAL TREATMENT REGISTERS, 5291 03:53:26,690 --> 03:53:30,994 SUCH AS ALSNET TO DEVELOP 5292 03:53:30,994 --> 03:53:31,995 THERAPIES TREATMENT PLANS AN 5293 03:53:31,995 --> 03:53:37,134 PRICING MODELS AND USE OF 5294 03:53:37,134 --> 03:53:39,336 PRIVACY PREPRESERVING RECORD 5295 03:53:39,336 --> 03:53:42,106 LINKERRING APPROACHES LINKS 5296 03:53:42,106 --> 03:53:43,273 BETWEEN REAL WORLD DATA AND 5297 03:53:43,273 --> 03:53:46,143 RESEARCH COHORT. IN TERMS OF 5298 03:53:46,143 --> 03:53:47,311 DATA RELATED TO OPPORTUNITIES 5299 03:53:47,311 --> 03:53:49,079 AVAILABLE FOR AI AND MACHINE 5300 03:53:49,079 --> 03:53:51,815 LEARNING AND DEEP LEARNING, WE 5301 03:53:51,815 --> 03:53:53,150 DISCUSSED THE YOU ARE GENERAL 5302 03:53:53,150 --> 03:53:55,752 NEED TO DEFINE GUIDELINES FOR 5303 03:53:55,752 --> 03:53:58,188 THE ETHICAL RESPONSIBLE 5304 03:53:58,188 --> 03:53:59,490 REPRODUCIBLE EXPLAINABLE 5305 03:53:59,490 --> 03:54:02,159 CRITICAL AND TRUSTWORTHY USE OF 5306 03:54:02,159 --> 03:54:06,563 AI. AND ALSO THINKING ABOUT THE 5307 03:54:06,563 --> 03:54:11,835 ENVIRONMENTAL IMPACTEDS OF USING 5308 03:54:11,835 --> 03:54:13,871 AI ESPECIALLY FOR MODEL TRAINING 5309 03:54:13,871 --> 03:54:17,074 AND INFERENCE. IN MANY TERMS OF 5310 03:54:17,074 --> 03:54:19,076 OPPORTUNITIES FOR THE EX ANDED 5311 03:54:19,076 --> 03:54:20,644 USE OF CLINICAL TRIALS DATA WE 5312 03:54:20,644 --> 03:54:23,547 DISCUSSED THE OPPORTUNITY TO 5313 03:54:23,547 --> 03:54:25,816 INCENTIVIZE THE DEVELOPMENT OF 5314 03:54:25,816 --> 03:54:27,784 PRECISION MEDICINE APPROACH IN 5315 03:54:27,784 --> 03:54:30,654 TRIAL DESIGN AND IMPLEMENTATION 5316 03:54:30,654 --> 03:54:32,623 IN THE DOMAIN OF OPEN SCIENCE 5317 03:54:32,623 --> 03:54:36,693 AND TEAM SCIENCE PRACTICES WE 5318 03:54:36,693 --> 03:54:40,230 WERE ALL VERY MUCH IN SUPPORT OF 5319 03:54:40,230 --> 03:54:41,598 THINKING ABOUT THE OPPORTUNITIES 5320 03:54:41,598 --> 03:54:43,934 TO ENGAGE ALL STAKEHOLDERS IN 5321 03:54:43,934 --> 03:54:48,005 THE DATA SHARING PROCESS TO 5322 03:54:48,005 --> 03:54:49,573 ENSURE THAT THERE'S EQUITY IN 5323 03:54:49,573 --> 03:54:52,109 TERMS OF THE BENEFITS AND RISKS 5324 03:54:52,109 --> 03:54:53,911 ASSOCIATED WITH DATA SHARING. 5325 03:54:53,911 --> 03:54:55,646 AND WE SEE THAT AS ALSO 5326 03:54:55,646 --> 03:54:56,880 INCLUDING PARTICIPANTS IN THAT 5327 03:54:56,880 --> 03:54:57,781 DISCUSSION AS WELL AS 5328 03:54:57,781 --> 03:55:02,986 COMMUNITIES. WE TALKED ABOUT 5329 03:55:02,986 --> 03:55:06,089 EXPANDING TRAINING PROGRAMS IN 5330 03:55:06,089 --> 03:55:12,229 DATA SCIENCE TO PROMOTE THE 5331 03:55:12,229 --> 03:55:14,131 EXPANSION OF SKILLS NECESSARY TO 5332 03:55:14,131 --> 03:55:15,132 WORK WITH THESE COMPLEX DATA 5333 03:55:15,132 --> 03:55:21,238 SETS. AND ALSO TO DEVELOP 5334 03:55:21,238 --> 03:55:23,807 REALLY RESEARCH INTO TEAM 5335 03:55:23,807 --> 03:55:25,242 SCIENCE SPECIFICALLY SO THE 5336 03:55:25,242 --> 03:55:28,011 SCIENCE OF TEAM SCIENCE IF YOU 5337 03:55:28,011 --> 03:55:30,547 WILL, TO BETTER UNDERSTAND 5338 03:55:30,547 --> 03:55:31,882 STRATEGIES THAT CAN EFFICIENTLY 5339 03:55:31,882 --> 03:55:34,117 AND COST EFFECTIVELY USE THE 5340 03:55:34,117 --> 03:55:36,286 LARGE TECHNICAL AND HUMAN 5341 03:55:36,286 --> 03:55:37,487 RESOURCES WITHIN AN OPEN SCIENCE 5342 03:55:37,487 --> 03:55:39,756 FRAMEWORK. FINALLY, THERE WAS 5343 03:55:39,756 --> 03:55:43,427 QUITE A BIT OF DISCUSSION ABOUT 5344 03:55:43,427 --> 03:55:47,231 ENSURING THAT THE TRANSPARENCY 5345 03:55:47,231 --> 03:55:49,933 AND RECIPROCITY WHEN SHARING 5346 03:55:49,933 --> 03:55:53,870 WITH INVESTIGATORS BOTH IN THE 5347 03:55:53,870 --> 03:55:55,706 U.S. AS WELL AS OUTSIDE THE U.S. 5348 03:55:55,706 --> 03:55:57,908 MAKING SURE THAT US-BASED 5349 03:55:57,908 --> 03:55:59,476 INVESTIGATORS CAN ACCESS 5350 03:55:59,476 --> 03:56:01,345 INTERNATIONAL DATA AND SAMPLES. 5351 03:56:01,345 --> 03:56:04,715 SO WITH THAT, I WOULD LIKE TO 5352 03:56:04,715 --> 03:56:08,919 OPEN UP THE SESSION FOR 5353 03:56:08,919 --> 03:56:11,455 QUESTIONS, BOTH OUR SPEAKERS AS 5354 03:56:11,455 --> 03:56:15,259 WELL AS TO THE AUDIENCE AND FOR 5355 03:56:15,259 --> 03:56:16,927 QUESTIONS FROM THE AUDIENCE, I 5356 03:56:16,927 --> 03:56:23,834 WANTED TO ASK IF THE INDIVIDUAL 5357 03:56:23,834 --> 03:56:24,635 COULD PRESENT THEMSELVESES WITH 5358 03:56:24,635 --> 03:56:26,203 HAIR NAME AS WELL AS 5359 03:56:26,203 --> 03:56:31,875 AFFILIATION. SO MAYBE WE CAN 5360 03:56:31,875 --> 03:56:32,209 START WITH -- 5361 03:56:32,209 --> 03:56:35,479 >> WE HAVE AN ONLINE PARTICIPANT 5362 03:56:35,479 --> 03:56:37,714 ASKING A QUESTION ABOUT THE A 5363 03:56:37,714 --> 03:56:42,486 FORCE STUDY. AND ACTC.C. THE A 5364 03:56:42,486 --> 03:56:44,554 FORCE IS IT DI IS VALUABLE TO 5365 03:56:44,554 --> 03:56:46,189 RESEARCH ERGS. DOES ACTK 5366 03:56:46,189 --> 03:56:47,190 CONSIDER SHARING DATA FROM OTHER 5367 03:56:47,190 --> 03:56:48,525 CLINICAL TRIALS? 5368 03:56:48,525 --> 03:56:50,927 >> THAT IS AN EXCELLENT 5369 03:56:50,927 --> 03:56:55,065 QUESTION. THANK YOU. SO WE ARE 5370 03:56:55,065 --> 03:56:57,434 WORKING ON APPLYING THE SAME 5371 03:56:57,434 --> 03:56:59,503 METHODS THAT I DESCRIBED HAVE 5372 03:56:59,503 --> 03:57:07,377 BEEN USED FOR THE A FORCE STUDY 5373 03:57:07,377 --> 03:57:09,579 RESPECTIVELY AND PERSPECTIVELY. 5374 03:57:09,579 --> 03:57:13,884 ONE EXAMPLE OF PROSPECTIVE 5375 03:57:13,884 --> 03:57:16,453 PROJECT WE WILL BE EMBARKING ON 5376 03:57:16,453 --> 03:57:18,789 SOON IS SHARING THE 5377 03:57:18,789 --> 03:57:19,389 PRE-RANDOMIZATION DATA FOR THE 5378 03:57:19,389 --> 03:57:21,825 HEAD STUDY SCHEDULED TO COMPLETE 5379 03:57:21,825 --> 03:57:22,926 ENROLLMENT BEFORE THE ENDS OF 5380 03:57:22,926 --> 03:57:28,999 THIS YEAR. SO WE EXPECT 5381 03:57:28,999 --> 03:57:30,067 PRE-RANDOMIZATION DATA FOR AHEAD 5382 03:57:30,067 --> 03:57:31,968 WILL BE AVAILABLE BY THE END OF 5383 03:57:31,968 --> 03:57:33,503 NEXT YEAR. 5384 03:57:33,503 --> 03:57:36,606 >> INCENTIVIZING -- PUTTING OUT 5385 03:57:36,606 --> 03:57:38,075 THERE MANY OF THE CLINICAL 5386 03:57:38,075 --> 03:57:39,876 STUDIES THAT WERE COMPLETED, 5387 03:57:39,876 --> 03:57:42,079 THOSE THAT FAILED AND THOSE THAT 5388 03:57:42,079 --> 03:57:44,081 ENABLED APPROVAL OF SOME DRUGS, 5389 03:57:44,081 --> 03:57:47,718 WHATEVER IF WE START WITH THE 5390 03:57:47,718 --> 03:57:49,319 ONES AND PUT THIS BIG DATA OUT 5391 03:57:49,319 --> 03:57:50,921 THERE, I'M SURE THERE'S GOING TO 5392 03:57:50,921 --> 03:57:52,989 BE MUCH MORE TO LEARN FROM THE 5393 03:57:52,989 --> 03:57:56,526 BIG DATA ON THIS INDIVIDUALS AND 5394 03:57:56,526 --> 03:57:57,961 RESPONSES AND VARIATIONS AND 5395 03:57:57,961 --> 03:58:00,764 PERHAPS DEFINING SOME SUBGROUPS 5396 03:58:00,764 --> 03:58:02,632 OF INDIVIDUALS WHOP MIGHT BE 5397 03:58:02,632 --> 03:58:04,334 FUNDERS WHO ARE MISSED IN THE 5398 03:58:04,334 --> 03:58:06,970 ACTION SO THESE DRUGS COULD BE 5399 03:58:06,970 --> 03:58:08,505 PROVES INTO BIOLOGY WHICH IS 5400 03:58:08,505 --> 03:58:12,042 VERY POWERFUL. 5401 03:58:12,042 --> 03:58:14,678 >> CONTAINER MAYOR CLINIC. QUICK 5402 03:58:14,678 --> 03:58:18,515 COMMENT AND A QUESTION. COMMENT 5403 03:58:18,515 --> 03:58:19,983 IS I APPRECIATED THE FACT 5404 03:58:19,983 --> 03:58:21,551 SHARING DATA ACCORDING TO NOT 5405 03:58:21,551 --> 03:58:23,019 ONLY FAIR BUT ALSO CARE 5406 03:58:23,019 --> 03:58:25,088 PRINCIPLES WAS HIGHLIGHTED HERE. 5407 03:58:25,088 --> 03:58:27,491 AND THAT'S SOMETHING THAT WE 5408 03:58:27,491 --> 03:58:28,925 NEED TO CONTINUE TO HARP UPON. 5409 03:58:28,925 --> 03:58:32,996 THANK YOU FOR BRINGING THAT UP. 5410 03:58:32,996 --> 03:58:34,664 THE QUESTION PERTAINS TO ALL THE 5411 03:58:34,664 --> 03:58:37,100 DATA RESOURCES, IT IS WONDERFUL 5412 03:58:37,100 --> 03:58:39,970 TO SEE THE INITIATIVES BRINGING 5413 03:58:39,970 --> 03:58:42,739 TOGETHER THE VARIETY OF DATA 5414 03:58:42,739 --> 03:58:46,410 RESOURCES IS EXEMPLIFIED IN THE 5415 03:58:46,410 --> 03:58:47,577 NAC DATA FRONT DOOR THAT 5416 03:58:47,577 --> 03:58:50,247 BRINGING TO NAC AND THE AD 5417 03:58:50,247 --> 03:58:52,215 KNOWLEDGE PORTAL BUT THERE IS 5418 03:58:52,215 --> 03:58:55,318 FAR MORE BEYOND THAT. AT THESE 5419 03:58:55,318 --> 03:58:56,420 MEETINGS WE HAVE BEEN DISCUSSING 5420 03:58:56,420 --> 03:58:58,121 IT WILL BE USEFUL TO HAVE A 5421 03:58:58,121 --> 03:59:03,293 DATABASE OF DATABASES. ARE THERE 5422 03:59:03,293 --> 03:59:06,596 PLANS FROM THE NIH, ALZHEIMER'S 5423 03:59:06,596 --> 03:59:09,566 ASSOCIATION AND OTHER FUNDERS TO 5424 03:59:09,566 --> 03:59:10,834 BUILD SOMETHING LIKE THAT 5425 03:59:10,834 --> 03:59:13,904 BECAUSE WE ONLY KNOW WHAT WE 5426 03:59:13,904 --> 03:59:14,104 KNOW. 5427 03:59:14,104 --> 03:59:17,674 >> I THINK YOU DID ONE OF OUR -- 5428 03:59:17,674 --> 03:59:18,809 DO YOU WANT TO TAKE THAT 5429 03:59:18,809 --> 03:59:19,075 QUESTION? 5430 03:59:19,075 --> 03:59:22,446 >> I THINK THAT IS AN EXCELLENT 5431 03:59:22,446 --> 03:59:23,880 SUGGESTION. THE DEVIL IN THE 5432 03:59:23,880 --> 03:59:28,351 DETAIL OF COURSE. WHAT SORT OF 5433 03:59:28,351 --> 03:59:32,155 INFORMATION WOULD BE INFORMATIVE 5434 03:59:32,155 --> 03:59:34,057 FRANKLY, PARTICULAR RESEARCH 5435 03:59:34,057 --> 03:59:36,092 QUESTIONS? HOW FORTHCOMING WOULD 5436 03:59:36,092 --> 03:59:38,395 THE DIFFERENT DATABASES BE IN 5437 03:59:38,395 --> 03:59:43,366 ALLOWING THAT TO HAPPEN? I WOULD 5438 03:59:43,366 --> 03:59:45,135 REALLY WELCOME THIS, THE TROUBLE 5439 03:59:45,135 --> 03:59:46,570 IS HAVING WHAT YOU MIGHT 5440 03:59:46,570 --> 03:59:49,806 DESCRIBE AS A TRUSTED THIRD 5441 03:59:49,806 --> 03:59:50,907 PARTY, WHICH CAN BE GOVERNMENT 5442 03:59:50,907 --> 03:59:52,709 FUNDED BUT IT DOESN'T MATTER, 5443 03:59:52,709 --> 03:59:55,712 THE POINT IS THEY ARE TRUSTED AS 5444 03:59:55,712 --> 03:59:57,914 INDEPENDENT THIRD PARTIES TO 5445 03:59:57,914 --> 03:59:58,715 REPRESENT ALL DIFFERENT 5446 03:59:58,715 --> 04:00:01,651 DATABASES. THE ISSUE THEN COMES 5447 04:00:01,651 --> 04:00:03,553 DOWN TO CONSISTENT DATA MODELS, 5448 04:00:03,553 --> 04:00:08,725 SO YOU ARE COMPARING APPLES WITH 5449 04:00:08,725 --> 04:00:11,828 APPLES EXPLICITLY. I THINK IT 5450 04:00:11,828 --> 04:00:13,330 WOULD WORK BUT I WOULD CERTAINLY 5451 04:00:13,330 --> 04:00:17,534 SUPPORT IT. 5452 04:00:17,534 --> 04:00:19,703 >> AID DO WANT TO POINT OUT 5453 04:00:19,703 --> 04:00:23,473 THERE IS A EFFORT IN BETA BY NLM 5454 04:00:23,473 --> 04:00:27,244 TO CATALOG DATA SETS ACROSS ITS 5455 04:00:27,244 --> 04:00:29,379 FOCUSING PRIMARILY ON DB GAP AND 5456 04:00:29,379 --> 04:00:32,516 ALL THE DATA RESOURCES. IT IS 5457 04:00:32,516 --> 04:00:36,152 IN BETA, THAT NEEDS TO BE SCOPED 5458 04:00:36,152 --> 04:00:38,788 BEYOND THAT BUT FINDING THE DATA 5459 04:00:38,788 --> 04:00:43,126 IS CLEARLY A BEGINNING. 5460 04:00:43,126 --> 04:00:45,529 >> IT IS A GREAT QUESTION, I 5461 04:00:45,529 --> 04:00:46,630 JUST THINK ONE OF THE THINGS 5462 04:00:46,630 --> 04:00:47,531 THAT WOULD BE REALLY IMPORTANT 5463 04:00:47,531 --> 04:00:49,299 IS TO TRY TO CONNECT THE 5464 04:00:49,299 --> 04:00:51,301 CLINICAL DATA THAT WE HAVE IN 5465 04:00:51,301 --> 04:00:53,470 SOME OF OUR CLINICAL DATA SETS, 5466 04:00:53,470 --> 04:00:56,306 TO THE OMICS DATA THAT WE HAVE 5467 04:00:56,306 --> 04:00:59,509 ON AGORA AND SAGE AND ET CETERA 5468 04:00:59,509 --> 04:01:00,810 THOSE LINKS WE ARE TRYING TO 5469 04:01:00,810 --> 04:01:04,014 TEST WITH SARAH AND DR. 5470 04:01:04,014 --> 04:01:05,382 (INDISCERNIBLE) WITH THE 5471 04:01:05,382 --> 04:01:05,949 TREATMENT LEVEL DATA WE ARE 5472 04:01:05,949 --> 04:01:09,286 TRYING TO GATHER IN ALSNET. BUT 5473 04:01:09,286 --> 04:01:11,021 THAT IS SOMETHING THAT I DON'T 5474 04:01:11,021 --> 04:01:12,489 KNOW IF WE HAVE MANAGED TO DO. 5475 04:01:12,489 --> 04:01:15,058 I'M NOT A DATA SCIENTIST. I KNOW 5476 04:01:15,058 --> 04:01:16,993 WE WILL ATTEMPT TO DO IT WITH 5477 04:01:16,993 --> 04:01:19,195 NAC. BUT I MEAN, I THINK IT IS 5478 04:01:19,195 --> 04:01:20,797 REALLY GREAT POINT. 5479 04:01:20,797 --> 04:01:22,299 >> WE HAVE SEEN BIG INTEREST 5480 04:01:22,299 --> 04:01:23,833 FROM THE NON-PROFIT 5481 04:01:23,833 --> 04:01:25,068 ORGANIZATIONS IN BRINGING 5482 04:01:25,068 --> 04:01:27,504 TOGETHER SOME OF THESE BIG 5483 04:01:27,504 --> 04:01:28,538 REPOSITORIES, CREATING A 5484 04:01:28,538 --> 04:01:32,342 DIALOGUE AND WORKING, MAYBE WE 5485 04:01:32,342 --> 04:01:33,777 MENTIONED ISSUE OF 5486 04:01:33,777 --> 04:01:34,544 STANDARDIZATION AND USE IT IN 5487 04:01:34,544 --> 04:01:36,446 DIFFERENT WAYS, META, WHEN I 5488 04:01:36,446 --> 04:01:40,350 TALK ABOUT STANDARDIZATION, I -- 5489 04:01:40,350 --> 04:01:42,385 THE OMICS DATA WE REPRODUCE 5490 04:01:42,385 --> 04:01:44,754 OMICS DATA THIS IS NOT GOING TO 5491 04:01:44,754 --> 04:01:46,756 HAPPEN IN ME TAN LOAMICS BUT 5492 04:01:46,756 --> 04:01:48,024 STANDARD DIEDING EVERYTHING ELSE 5493 04:01:48,024 --> 04:01:50,360 TO MAKE BIOREPOSITORIES WORK, 5494 04:01:50,360 --> 04:01:51,928 COLLABORATE, LEARN TOGETHER, AND 5495 04:01:51,928 --> 04:01:53,496 IMPROVE THE WHOLE PROCESS, IS 5496 04:01:53,496 --> 04:02:00,103 THIS HAPPENING? ANNA? ARE THESE 5497 04:02:00,103 --> 04:02:01,571 REPOSITORIES MEETING, 5498 04:02:01,571 --> 04:02:02,672 COLLABORATING, DISCUSSING THE 5499 04:02:02,672 --> 04:02:05,675 FUTURE HOW IT CAN WORK FOR ALL 5500 04:02:05,675 --> 04:02:05,942 OF US? 5501 04:02:05,942 --> 04:02:08,511 >> YES. I THINK THE IN HIA HAS 5502 04:02:08,511 --> 04:02:09,946 BEEN DOING A GREAT JOB AND THIS 5503 04:02:09,946 --> 04:02:11,648 IS LED BY META OVER THE PAST 5504 04:02:11,648 --> 04:02:14,084 YEAR BRINGING TOGETHER THESE 5505 04:02:14,084 --> 04:02:15,352 REPOSITORIES TO START HAVING 5506 04:02:15,352 --> 04:02:16,553 THESE CONVERSATIONS ABOUT WHAT 5507 04:02:16,553 --> 04:02:20,757 IS REALLY REQUIRED. THERE IS 5508 04:02:20,757 --> 04:02:22,425 THIS EFFORT TO ACCEPTOR 5509 04:02:22,425 --> 04:02:24,227 EVERYTHING AROUND USE CASES. 5510 04:02:24,227 --> 04:02:25,762 BECAUSE AS JOHN WAS POINTING 5511 04:02:25,762 --> 04:02:27,564 OUT, THE DEVIL IS IN THE DETAILS 5512 04:02:27,564 --> 04:02:32,102 HERE. SO WHAT ARE THE REARS 5513 04:02:32,102 --> 04:02:34,638 TRYING TO ASK AND HOW CAN WE 5514 04:02:34,638 --> 04:02:36,873 HELP ANSWER IT WITH THE WAY WE 5515 04:02:36,873 --> 04:02:38,675 BILL OUR SYSTEMS AND DEVELOP OUR 5516 04:02:38,675 --> 04:02:40,977 INTEROPERABILITY. 5517 04:02:40,977 --> 04:02:42,278 >> QUESTION FROM THE AUDIENCE. 5518 04:02:42,278 --> 04:02:44,314 >> HI. SARAH (INDISCERNIBLE) 5519 04:02:44,314 --> 04:02:46,549 FROM MICHIGAN STATE UNIVERSITY. 5520 04:02:46,549 --> 04:02:47,651 FIRST THANK YOU TO EVERYBODY 5521 04:02:47,651 --> 04:02:49,219 INVOLVED IN THIS CONFERENCE. I'M 5522 04:02:49,219 --> 04:02:50,353 RELATIVELY NEW TO THE FIELD AND 5523 04:02:50,353 --> 04:02:52,122 IT'S BEEN REALLY GREAT TO HEAR 5524 04:02:52,122 --> 04:02:53,356 ALL THE RESOURCES AND ALL THE 5525 04:02:53,356 --> 04:02:55,392 THINGS THAT ARE AVAILABLE AND 5526 04:02:55,392 --> 04:02:57,093 HEAR FROM SUCH WONDERFUL EXPERTS 5527 04:02:57,093 --> 04:02:58,461 AND TO GET A GREAT IDEA OF WHERE 5528 04:02:58,461 --> 04:03:00,463 THE FIELD IS HEADING IN THE 5529 04:03:00,463 --> 04:03:02,499 FUTURE AS WELL. TO MY QUESTION, 5530 04:03:02,499 --> 04:03:03,400 IT KIND OF BUILDS OFF THE 5531 04:03:03,400 --> 04:03:06,269 PREVIOUS QUESTION, IN IN TERMS 5532 04:03:06,269 --> 04:03:08,038 OF MAKING NEW INVESTIGATORS OR 5533 04:03:08,038 --> 04:03:09,939 OTHER INVESTIGATORS IN THE FIELD 5534 04:03:09,939 --> 04:03:12,242 AWARE OF THESE RESOURCES, APART 5535 04:03:12,242 --> 04:03:13,510 FROM COMING TO WONDERFUL 5536 04:03:13,510 --> 04:03:16,179 CONFERENCES AND SYMPOSIUMS SUCH 5537 04:03:16,179 --> 04:03:18,048 AS THIS, ARE THERE EFFORTS WHICH 5538 04:03:18,048 --> 04:03:20,417 TO REACH OUT AND TO MAKE PEOPLE 5539 04:03:20,417 --> 04:03:22,118 AWARE OF WHAT IS AVAILABLE, 5540 04:03:22,118 --> 04:03:23,987 CONNECT RESEARCHERS THAT MIGHT 5541 04:03:23,987 --> 04:03:26,589 HAVE SIMILAR FIELDS OR SIMILAR 5542 04:03:26,589 --> 04:03:27,624 INTERESTS SO THAT WE CAN START 5543 04:03:27,624 --> 04:03:29,325 TO BRING THE PEOPLE TOGETHER NOT 5544 04:03:29,325 --> 04:03:31,594 JUST THE DATA? 5545 04:03:31,594 --> 04:03:34,831 >> MAYBE I CAN START. ONE OF THE 5546 04:03:34,831 --> 04:03:36,433 WAYS IN WHICH WE TRY TO DO THAT 5547 04:03:36,433 --> 04:03:38,435 IS TO PROVIDE PLATFORMS A THE 5548 04:03:38,435 --> 04:03:39,402 ALZHEIMER'S ASSOCIATION 5549 04:03:39,402 --> 04:03:40,870 INTERNATIONAL CONFERENCE. SO EF 5550 04:03:40,870 --> 04:03:43,106 WITH FOR EXAMPLE SHARED BOOTH 5551 04:03:43,106 --> 04:03:45,175 WITH GAIN.ORG WITH ADDI 5552 04:03:45,175 --> 04:03:48,178 ALZHEIMER'S DATA INITIATIVE, AND 5553 04:03:48,178 --> 04:03:53,049 WE ALSO HAVE SESSIONS FOR THE 5554 04:03:53,049 --> 04:03:55,652 PRECISION MEDICINE PROGRAMS, IT 5555 04:03:55,652 --> 04:03:58,354 IS A LOT OF DAYS PRE-MEETINGS AT 5556 04:03:58,354 --> 04:04:00,924 AIC AND WE HAVE HAD SUCCESSFULLY 5557 04:04:00,924 --> 04:04:02,392 HAD THEM A FEW YEARS IN A ROW. 5558 04:04:02,392 --> 04:04:03,660 SO THERE'S LOTS OF OPPORTUNITIES 5559 04:04:03,660 --> 04:04:05,095 AT THE CONFERENCES IN ORDER TO 5560 04:04:05,095 --> 04:04:06,763 ENGAGE WITH ALL OF THESE GROUPS 5561 04:04:06,763 --> 04:04:09,532 INCLUDING THE EDST AND NAC AND 5562 04:04:09,532 --> 04:04:11,835 SO MANY OTHERS, THERE'S 5563 04:04:11,835 --> 04:04:14,304 WORKSHOPS AND YOU HEARD DR. 5564 04:04:14,304 --> 04:04:15,772 HOHMAN MENTION WORKSHOPS TO 5565 04:04:15,772 --> 04:04:17,907 TEACH PEOPLE HOW TO USE THESE 5566 04:04:17,907 --> 04:04:19,242 BECAUSE THESE ARE BIG DATA SETS, 5567 04:04:19,242 --> 04:04:21,444 IF YOU ARE NOT A DATA SCIENTIST 5568 04:04:21,444 --> 04:04:22,812 LIKE ME YOU GET LOST AND YOU 5569 04:04:22,812 --> 04:04:24,380 DONE KNOW WHERE TO START. SO 5570 04:04:24,380 --> 04:04:26,382 THESE ARE SOME EFFORTS. PERHAPS 5571 04:04:26,382 --> 04:04:27,784 THERE'S -- ONE OF THE CHALLENGES 5572 04:04:27,784 --> 04:04:29,519 WE CAN TAKE ON IS TO TRY TO 5573 04:04:29,519 --> 04:04:32,422 FIGURE OUT HOW TO CENTRALIZE 5574 04:04:32,422 --> 04:04:34,424 THOSE IN ONE PLACE SO THEY 5575 04:04:34,424 --> 04:04:35,859 ADVERTISE AND NOT JUST -- THEY 5576 04:04:35,859 --> 04:04:37,293 ARE SCATTERED ACROSS LIKE THAT 5577 04:04:37,293 --> 04:04:39,162 TYPE OF A CONFERENCE AND MAIN WE 5578 04:04:39,162 --> 04:04:41,965 CAN MAKE MORE AN EFFORT TO 5579 04:04:41,965 --> 04:04:45,835 CENTRALIZE ALL OF THE 5580 04:04:45,835 --> 04:04:46,669 OPPORTUNITIES AVAILABLE FOR 5581 04:04:46,669 --> 04:04:47,971 PEOPLE. THANK YOU FOR THAT 5582 04:04:47,971 --> 04:04:48,204 COMMENT. 5583 04:04:48,204 --> 04:04:50,240 >> I WANT TO ADD TO THAT. I 5584 04:04:50,240 --> 04:04:52,041 THINK PART OF BRINGING PEOPLING 5585 04:04:52,041 --> 04:04:53,943 TO INVOLVES ENCOURAGING AND 5586 04:04:53,943 --> 04:04:55,278 EMPOWERING BIOMEDICAL 5587 04:04:55,278 --> 04:04:57,680 RESEARCHERS TO USE AI ENABLED 5588 04:04:57,680 --> 04:04:59,048 TOOLS BECAUSE IT IS A BARRIER TO 5589 04:04:59,048 --> 04:05:01,417 ENTRY TO A LOT OF THEM, THEY GET 5590 04:05:01,417 --> 04:05:02,786 INTIMIDATED. THIS IS ALL NEW 5591 04:05:02,786 --> 04:05:03,820 SCIENCE. SO ONE OF THE THINGS 5592 04:05:03,820 --> 04:05:08,691 THAT WE TRY TO INCORPORATE INTO 5593 04:05:08,691 --> 04:05:13,196 OUR PLATFORM ARE SORT OF 5594 04:05:13,196 --> 04:05:19,469 EXTENSIVE GUIDANCE SYSTEM AND 5595 04:05:19,469 --> 04:05:20,603 JUST BASICALLY ON BOARDING 5596 04:05:20,603 --> 04:05:22,505 PEOPLE INTO THE PROCESS AND 5597 04:05:22,505 --> 04:05:24,073 GUIDING THEM THROUGH IT. WE SET 5598 04:05:24,073 --> 04:05:26,943 ASIDE A LOT OF TIME FOR ONE ON 5599 04:05:26,943 --> 04:05:29,112 ONE MEETINGS OR HELP SESSIONS AS 5600 04:05:29,112 --> 04:05:32,182 WELL. SO THERE IS A LOT 5601 04:05:32,182 --> 04:05:33,349 OUTREACH WHEN YOU ARE BUILDING A 5602 04:05:33,349 --> 04:05:34,117 PLATFORM THAT NEEDS TO BE 5603 04:05:34,117 --> 04:05:36,152 CONSIDERED JUST TO SORT OF BREAK 5604 04:05:36,152 --> 04:05:37,387 DOWN BARRIERS TO ENTRY FROM 5605 04:05:37,387 --> 04:05:38,721 PEOPLE WANTING TO -- THAT WANT 5606 04:05:38,721 --> 04:05:41,891 TO USE THE TECHNOLOGY BUT FEEL 5607 04:05:41,891 --> 04:05:46,095 LIKE MAYBE THEY AREN'T READY. 5608 04:05:46,095 --> 04:05:48,932 >> BUILDING ON THAT, I WANT TO 5609 04:05:48,932 --> 04:05:51,901 GIVE -- FIRST OF ALL, GRATITUDE 5610 04:05:51,901 --> 04:05:54,571 TO EVERYONE WHO IS CREATING 5611 04:05:54,571 --> 04:05:58,675 THESE RESOURCES THAT BENCH 5612 04:05:58,675 --> 04:06:00,677 SCIENTISTS CAN NOW ENTER INTO 5613 04:06:00,677 --> 04:06:02,512 THE DATA SCIENCE WORLD. AND I 5614 04:06:02,512 --> 04:06:04,581 WANT TO GIVE A SPECIAL SHOUT OUT 5615 04:06:04,581 --> 04:06:11,754 TO ANNA GRE GREENWOOD WHO HAS SE 5616 04:06:11,754 --> 04:06:17,393 BIONETWORKS, EVERY TIME WE OFFER 5617 04:06:17,393 --> 04:06:23,633 COURSE IN NIAT PRE-DONNING GRANT 5618 04:06:23,633 --> 04:06:27,937 FOR PRE-FELLOWS GIVES A LECTURE 5619 04:06:27,937 --> 04:06:32,542 ON THE AMP AD RESOURCE. AND HOW 5620 04:06:32,542 --> 04:06:35,144 WE UTILIZE THAT RESOURCE TO 5621 04:06:35,144 --> 04:06:39,749 ACTUALLY -- THIS IS CATHY ROGERS 5622 04:06:39,749 --> 04:06:42,418 COURSE, AND DEVELOPMENT WHERE 5623 04:06:42,418 --> 04:06:44,087 THE GRADUATE STUDENTS, 5624 04:06:44,087 --> 04:06:45,722 PRE-DOCTORAL FELLOWS AND 5625 04:06:45,722 --> 04:06:47,090 GRADUATE STUDENTS AT LARGE USE 5626 04:06:47,090 --> 04:06:50,526 THE AMP AD TO SELECT A TARGET, 5627 04:06:50,526 --> 04:06:52,195 BUILD A PROGRAM OR RESEARCH 5628 04:06:52,195 --> 04:06:55,832 AROUND THAT, AND ACTUALLY MOVE 5629 04:06:55,832 --> 04:06:58,401 THAT INTO A COMMERCIALIZATION 5630 04:06:58,401 --> 04:07:00,103 PLAN. SO THE POINT HERE IS IS 5631 04:07:00,103 --> 04:07:03,273 THAT, THE NEXT GENERATION OF 5632 04:07:03,273 --> 04:07:06,175 DATA SCIENTIST, BENCH SCIENTISTS 5633 04:07:06,175 --> 04:07:08,978 COMING TOGETHER, IS ACTUALLY 5634 04:07:08,978 --> 04:07:10,079 BEING BUILT THROUGH SOME OF 5635 04:07:10,079 --> 04:07:12,715 THESE TRAINING PROGRAMS. I KNOW 5636 04:07:12,715 --> 04:07:15,084 IT IS A LOT MORE WORK FOR ALL OF 5637 04:07:15,084 --> 04:07:18,755 YOU BUT IF YOU CAN FOLLOW ANNA'S 5638 04:07:18,755 --> 04:07:21,291 LEAD HERE, THAT WOULD BE GREAT. 5639 04:07:21,291 --> 04:07:25,628 >> WE SECOND THIS AND MUCH 5640 04:07:25,628 --> 04:07:29,065 GRATITUDE, AMAZING WORK YOU HAVE 5641 04:07:29,065 --> 04:07:30,433 DONE AND GREAT DEDICATION 5642 04:07:30,433 --> 04:07:35,405 THROUGHOUT THE YEARS. THANK YOU 5643 04:07:35,405 --> 04:07:36,806 >> A QUESTION ON THE RIGHT. 5644 04:07:36,806 --> 04:07:40,576 >> I'M MARINA FROM UCSF, I ONLY 5645 04:07:40,576 --> 04:07:42,412 A COMPUTATIONAL SCIENTIST. I AM 5646 04:07:42,412 --> 04:07:45,481 AMAZING AD ALL THE AMAZING DATA 5647 04:07:45,481 --> 04:07:46,950 SHARING EFFORTS THAT WERE 5648 04:07:46,950 --> 04:07:47,951 MENTIONED DURING SESSION AND I 5649 04:07:47,951 --> 04:07:50,253 HAVE BEEN SLACKING MY GRADUATE 5650 04:07:50,253 --> 04:07:51,921 STUDENTS AND TAKING PICTURES 5651 04:07:51,921 --> 04:07:53,356 THROUGHOUT THE PRESENTATIONS. 5652 04:07:53,356 --> 04:07:54,691 ALSO THE COMPUTATIONAL TOOLS 5653 04:07:54,691 --> 04:07:56,993 THAT WERE PRESENTED. I HAVE A 5654 04:07:56,993 --> 04:07:59,195 THOUGHT AND A QUESTION. THOUGHT 5655 04:07:59,195 --> 04:08:00,129 WAS STEMMING FROM THE QUESTION 5656 04:08:00,129 --> 04:08:03,666 ASKED EARLIER, ONE APPROACH TO 5657 04:08:03,666 --> 04:08:05,468 CONSIDER MIGHT BE, I DON'T KNOW 5658 04:08:05,468 --> 04:08:06,602 IF THIS HAS BEEN DONE IN THE 5659 04:08:06,602 --> 04:08:09,505 ALZHEIMER'S SPACE IS TO LAUNCH 5660 04:08:09,505 --> 04:08:12,308 SOME COMPUTATIONAL CHALLENGES 5661 04:08:12,308 --> 04:08:13,743 BASED ON SOME OF THESE 5662 04:08:13,743 --> 04:08:15,545 INCREDIBLE RESOURCES. WE HAVE 5663 04:08:15,545 --> 04:08:17,547 BEEN TALKING A LOT ABOUT 5664 04:08:17,547 --> 04:08:19,248 BRINGING THE DISCOVERY SCIENCES 5665 04:08:19,248 --> 04:08:21,050 OR CLINICIANS TO THE DATA BUT WE 5666 04:08:21,050 --> 04:08:22,352 ALSO WANT TO ATTRACT 5667 04:08:22,352 --> 04:08:23,252 COMPUTATIONAL PEOPLE WHO MIGHT 5668 04:08:23,252 --> 04:08:25,054 NOT BE WORKING MANY THE 5669 04:08:25,054 --> 04:08:26,589 ALZHEIMER'S SPACE AND THIS MIGHT 5670 04:08:26,589 --> 04:08:30,393 BE AN OPPORTUNITY TO EXPLORE. 5671 04:08:30,393 --> 04:08:32,996 THE QUESTION THAT I HAVE IS IN 5672 04:08:32,996 --> 04:08:36,099 THE CONTEXT OF THE PATIENT 5673 04:08:36,099 --> 04:08:37,467 SESSION YESTERDAY MORNING, WHAT 5674 04:08:37,467 --> 04:08:39,235 ARE YOUR THOUGHTS? I DON'T KNOW 5675 04:08:39,235 --> 04:08:40,670 THE ANSWER TO THIS, ABOUT 5676 04:08:40,670 --> 04:08:42,238 BRIDGING THE COMPUTATIONAL 5677 04:08:42,238 --> 04:08:44,273 EFFORTS THE DATA SHARING TO ALSO 5678 04:08:44,273 --> 04:08:45,842 BRING BACK TO THE COMMUNITY AND 5679 04:08:45,842 --> 04:08:50,980 THE PATIENTS AND HOW DO WE GO -- 5680 04:08:50,980 --> 04:08:55,284 >> ANNA, DID YOU WANT TO TALK 5681 04:08:55,284 --> 04:08:55,785 ABOUT THE PETITION? 5682 04:08:55,785 --> 04:08:58,621 >> SURE. SAGE BIONETWORKS THEY 5683 04:08:58,621 --> 04:08:59,555 HAVE THEIR JUNE CHALLENGE 5684 04:08:59,555 --> 04:09:02,492 PLATFORM WHICH IS AMAZE. AT NAC 5685 04:09:02,492 --> 04:09:04,293 ONE THING WE ARE PUSHING FORWARD 5686 04:09:04,293 --> 04:09:06,662 ARE SOME OF THESE DATA 5687 04:09:06,662 --> 04:09:07,797 CHALLENGES, PARTICULARLY DURING 5688 04:09:07,797 --> 04:09:09,899 RENEWAL PERIOD TO HELP BUT WE 5689 04:09:09,899 --> 04:09:11,234 WANT TO BRING TOGETHER SOME OF 5690 04:09:11,234 --> 04:09:13,202 THESE LONG STANDING DATA STREAMS 5691 04:09:13,202 --> 04:09:16,939 LIKE UNIFORM DATA SET WITH RICH 5692 04:09:16,939 --> 04:09:19,275 PHENOTYPIC DATA WITH NEW DATA 5693 04:09:19,275 --> 04:09:20,443 STREAMS, BIOMARKER DATA, ET 5694 04:09:20,443 --> 04:09:23,613 CETERA. SO WE WANT TO BRING 5695 04:09:23,613 --> 04:09:24,814 TOGETHER KNOWING THESE 5696 04:09:24,814 --> 04:09:25,848 CHALLENGES ARE INCREDIBLY 5697 04:09:25,848 --> 04:09:28,084 EFFECTIVE WAY THE CREATE 5698 04:09:28,084 --> 04:09:29,819 DEMOCRATIZE RESEARCH PROCESS 5699 04:09:29,819 --> 04:09:31,954 GREAT NEW ON LAMPS. WE ARE 5700 04:09:31,954 --> 04:09:33,523 INCREDIBLY EXCITED -- ONRAMPS 5701 04:09:33,523 --> 04:09:35,224 AND WE ARE EXCITED TO DRIVE 5702 04:09:35,224 --> 04:09:37,326 THOSE FORWARD. OVER THE NEXT 5703 04:09:37,326 --> 04:09:41,431 COUPLE OF YEARS. 5704 04:09:41,431 --> 04:09:49,439 >> MARINA WANT TO -- YOU HAVE 5705 04:09:49,439 --> 04:09:50,440 ANYTHING? 5706 04:09:50,440 --> 04:09:53,810 >> YEP. SO I THINK WHAT WE WOULD 5707 04:09:53,810 --> 04:09:58,247 LOVE TO BE ABLE DO AND AGAIN 5708 04:09:58,247 --> 04:09:59,615 ALSMAP JUST BUILDING OUT ALL OF 5709 04:09:59,615 --> 04:10:02,051 THESE PORTIONS OF IT, IS TO 5710 04:10:02,051 --> 04:10:03,519 CREATE AN OPPORTUNITY FOR 5711 04:10:03,519 --> 04:10:05,888 PATIENTS THEMSELVES WHO ARE IN 5712 04:10:05,888 --> 04:10:07,256 THESE -- TAKING THESE 5713 04:10:07,256 --> 04:10:08,157 MEDICATIONS, TO COMMUNICATE 5714 04:10:08,157 --> 04:10:11,094 AMONG EACH OTHER. TO CREATE A 5715 04:10:11,094 --> 04:10:12,328 COMMUNITY OF AND EMPOWER THEM 5716 04:10:12,328 --> 04:10:13,663 NOT ONLY TO PERHAPS ASK 5717 04:10:13,663 --> 04:10:16,032 QUESTIONS OF EACH OTHER BUT THEN 5718 04:10:16,032 --> 04:10:18,267 EVEN LOOK AT THE DATA AVAILABLE. 5719 04:10:18,267 --> 04:10:20,470 THEY ARE PART OF IT. THEY 5720 04:10:20,470 --> 04:10:21,938 CONTRIBUTE TO IT. SO THAT IS 5721 04:10:21,938 --> 04:10:25,475 SORT OF I WOULD SAUCY ALSNET 5722 04:10:25,475 --> 04:10:28,811 2.0, WE ARE TRYING TO BUILD IT 5723 04:10:28,811 --> 04:10:30,279 AND CREATE OPPORTUNITIES FOR A 5724 04:10:30,279 --> 04:10:32,582 COMMUNITY. AND TO GIVE BACK TO 5725 04:10:32,582 --> 04:10:35,118 THEM AND HAVE THEM GIVE EVEN 5726 04:10:35,118 --> 04:10:36,352 MORE, BECAUSE THEY PROBABLY 5727 04:10:36,352 --> 04:10:37,353 WOULD BE MORE THAN WILLING TO 5728 04:10:37,353 --> 04:10:38,488 TALK TO EACH OTHER ABOUT WHAT 5729 04:10:38,488 --> 04:10:40,790 THEY ARE EXPERIENCING. THANK 5730 04:10:40,790 --> 04:10:41,357 YOU. 5731 04:10:41,357 --> 04:10:44,360 >> I THINK IT IS A HUGE POINT. 5732 04:10:44,360 --> 04:10:48,865 WHO IS LIKE ME AND HOW CAN I 5733 04:10:48,865 --> 04:10:53,102 LEARN FROM OTHERS -- THE ISSUE 5734 04:10:53,102 --> 04:10:55,571 THAT WAS RAISED BY THE ADVOCACY 5735 04:10:55,571 --> 04:10:57,106 GROUPS, WAS INCREDIBLY 5736 04:10:57,106 --> 04:10:59,509 IMPORTANT. THERE IS THE 5737 04:10:59,509 --> 04:11:00,743 QUESTION, WHAT -- HOW CAN I 5738 04:11:00,743 --> 04:11:04,814 LEARN AND WHO IS LIKE ME? AND WE 5739 04:11:04,814 --> 04:11:07,750 ARE REALLY BUILDK PLATFORMS AN 5740 04:11:07,750 --> 04:11:08,985 RESOURCES TO GET COMMUNITIESING 5741 04:11:08,985 --> 04:11:10,486 TO TO FIND OTHERS WHO ARE LIKE 5742 04:11:10,486 --> 04:11:12,588 THEM -- COMMUNITIES TOGETHER TO 5743 04:11:12,588 --> 04:11:14,624 FIND OTHERS LEARN TOGETHER AND 5744 04:11:14,624 --> 04:11:15,758 OPTIMIZE TREATMENT STRATEGIES 5745 04:11:15,758 --> 04:11:17,360 AND CARE MOVING FORWARD SO WE 5746 04:11:17,360 --> 04:11:20,796 TAKE THIS VERY SERIOUSLY AND 5747 04:11:20,796 --> 04:11:23,032 THERE IS MORE THAT IS INSPIRING 5748 04:11:23,032 --> 04:11:25,568 US FROM THE EUROPEAN MODELS. 5749 04:11:25,568 --> 04:11:27,170 AGAIN THE DUTCH ARE PUTTING THE 5750 04:11:27,170 --> 04:11:28,371 POWER BACK IN THE HANDS OF THE 5751 04:11:28,371 --> 04:11:29,605 PEOPLE THAT CONTRIBUTE THE DATA 5752 04:11:29,605 --> 04:11:32,508 SO THAT THROUGH THE DIGITAL 5753 04:11:32,508 --> 04:11:33,743 PRINTS THEY CAN ENABLE AND 5754 04:11:33,743 --> 04:11:36,212 DECIDE WHAT DATA TO SHARE AND 5755 04:11:36,212 --> 04:11:38,014 THEY ARE PART OF LEARNING, WE 5756 04:11:38,014 --> 04:11:39,482 IMMEDIATE TO MAKE DATA SIMPLE 5757 04:11:39,482 --> 04:11:41,350 ENOUGH TO LEARN AND TO 5758 04:11:41,350 --> 04:11:44,453 UNDERSTAND. FROM US METABOLISM 5759 04:11:44,453 --> 04:11:48,324 IS CARDIOVASCULAR HEALTH, THERE 5760 04:11:48,324 --> 04:11:50,560 IS A LOT WE CAN SHARE. I HOPE WE 5761 04:11:50,560 --> 04:11:52,128 CAN DO THIS WITH A POINTER. AS 5762 04:11:52,128 --> 04:11:55,565 WE START TO LOOK AT THE POINTER 5763 04:11:55,565 --> 04:11:59,202 BASELINE WITH THE TEAM, TO BE 5764 04:11:59,202 --> 04:12:00,870 ABLE TO REDUCE COMPLEXITY OF A 5765 04:12:00,870 --> 04:12:02,104 THOUSAND THINGS WE MEASURE AND 5766 04:12:02,104 --> 04:12:04,874 BE ABLE TO TELL THEM I CAN GIVE 5767 04:12:04,874 --> 04:12:08,411 YOU SOMETHING MORE THAN GLUCOSE 5768 04:12:08,411 --> 04:12:10,179 THAT WOULD TELL YOU SOMETHING 5769 04:12:10,179 --> 04:12:10,513 ABOUT THAT. 5770 04:12:10,513 --> 04:12:12,348 >> I JUST BRIEFLY ALSO MENTION 5771 04:12:12,348 --> 04:12:14,417 THAT FOR THE ACCELERATING 5772 04:12:14,417 --> 04:12:17,053 MEDICINES PARTNERSHIP AT THE 5773 04:12:17,053 --> 04:12:18,955 NEXT PLACE FOR PARKINSON DISEASE 5774 04:12:18,955 --> 04:12:20,823 AND RELATED DATES ORDERS WE ARE 5775 04:12:20,823 --> 04:12:22,291 INTEGRATED PERSONS WITH LIVED 5776 04:12:22,291 --> 04:12:23,292 EXPERIENCE PATIENTS AND 5777 04:12:23,292 --> 04:12:26,429 CAREGIVERS INTO OUR STEERING 5778 04:12:26,429 --> 04:12:27,463 COMMITTEE AS WELL AS BOSHING 5779 04:12:27,463 --> 04:12:30,132 GROUPS AND THIS IS A MODEL WE 5780 04:12:30,132 --> 04:12:32,034 RECENTLY -- WORKING GROUPS. THIS 5781 04:12:32,034 --> 04:12:34,704 IS ALSO A MODEL FOR ACCELERATING 5782 04:12:34,704 --> 04:12:36,939 MEDICINE. 5783 04:12:36,939 --> 04:12:39,075 >> MIGHT MAKE A COMMENT ON 5784 04:12:39,075 --> 04:12:43,946 REDUCING COMPLEXITY. COMPLEXITY 5785 04:12:43,946 --> 04:12:45,448 BRINGS INFORMATION, YOU CAN 5786 04:12:45,448 --> 04:12:48,084 REDUCE COMPLEXITY AND REDUCE THE 5787 04:12:48,084 --> 04:12:50,086 FORMATIVENESS OF THE DATA. I 5788 04:12:50,086 --> 04:12:54,123 THINK THE REALLY SUIT IS 5789 04:12:54,123 --> 04:12:54,890 MAXIMIZING SCIENTIFIC 5790 04:12:54,890 --> 04:12:57,193 OPPORTUNITY. THAT DOES MEAN THAT 5791 04:12:57,193 --> 04:13:00,263 THERE IS A TRADE OFF HERE OF 5792 04:13:00,263 --> 04:13:01,864 CONSTRAINING SOME INTELLECTUAL 5793 04:13:01,864 --> 04:13:04,300 FREEDOM. ONE EXAMPLE. IF YOU GO 5794 04:13:04,300 --> 04:13:06,602 TO THE UK AND YOU HAVE TO GET A 5795 04:13:06,602 --> 04:13:12,141 PLUG ADAPTER. IT IS A REAL PAIN. 5796 04:13:12,141 --> 04:13:13,242 JUST IMAGINE EVERY CITY IN THE 5797 04:13:13,242 --> 04:13:16,979 UK HAD A DIFFERENT PLUG ADAPTER. 5798 04:13:16,979 --> 04:13:17,780 YOUR OPPORTUNITY WOULD BE 5799 04:13:17,780 --> 04:13:19,548 LIMITED BUT YOUR FREEDOM WOULD 5800 04:13:19,548 --> 04:13:21,350 BE WONDERFUL IF YOU LIVE IN THAT 5801 04:13:21,350 --> 04:13:24,887 CITCITY. THERE REALLY IS A CASER 5802 04:13:24,887 --> 04:13:27,590 CENTRALIZATION DISCUSSION 5803 04:13:27,590 --> 04:13:29,492 COMMUNITY-LED LIMITATION OF %- 5804 04:13:29,492 --> 04:13:32,461 LIKE CONSTRAINING OF INNOVATION 5805 04:13:32,461 --> 04:13:34,463 IN ORDER TO MAINTAIN AND 5806 04:13:34,463 --> 04:13:36,132 MAXIMIZE OPPORTUNITIES. BECAUSE 5807 04:13:36,132 --> 04:13:38,000 IT WILL BE OPPORTUNITY WHICH 5808 04:13:38,000 --> 04:13:39,402 ACTUALLY BRINGS RESULT AND 5809 04:13:39,402 --> 04:13:42,271 GENERATES THE WORK, NOT SOME 5810 04:13:42,271 --> 04:13:44,373 CRACK POT ACADEMIC HAVING A 5811 04:13:44,373 --> 04:13:46,809 BRIGHT IDEA HOW WE WOULD LIKE TO 5812 04:13:46,809 --> 04:13:51,714 MAKE THIS DATA, IT IS 5813 04:13:51,714 --> 04:13:53,015 HYPOTHESIS. I KNOW THE THOUGHTS 5814 04:13:53,015 --> 04:13:56,552 ARE NOT NORMALLY ENCOURAGED, BUT 5815 04:13:56,552 --> 04:13:58,688 I DO PUT TO YOU WOULD YOU RATHER 5816 04:13:58,688 --> 04:14:04,960 HAVE TO HAVE ONE IN PLACE OR 50 5817 04:14:04,960 --> 04:14:05,261 IN PLACE. 5818 04:14:05,261 --> 04:14:06,929 >> I THINK WE HAVE TIME FOR ONE 5819 04:14:06,929 --> 04:14:07,263 LAST QUESTION. 5820 04:14:07,263 --> 04:14:07,830 >> NO. 5821 04:14:07,830 --> 04:14:08,664 >> NO. 5822 04:14:08,664 --> 04:14:11,233 >> WE DON'T. OKAY. 5823 04:14:11,233 --> 04:14:14,704 >> COULD I JUST MAKE A POINT 5824 04:14:14,704 --> 04:14:16,605 THOUGH THAT I WAS OF 5825 04:14:16,605 --> 04:14:17,306 (OVERLAPPING SPEAKERS) FOR THOSE 5826 04:14:17,306 --> 04:14:19,041 OF YOU THAT ARE NEW TO THE 5827 04:14:19,041 --> 04:14:21,243 FIELD, AND ALSO YOU THAT ARE 5828 04:14:21,243 --> 04:14:22,378 WONDERING WHAT RESOURCES ARE OUT 5829 04:14:22,378 --> 04:14:23,746 THERE. AS YOU HEAR, THERE IS A 5830 04:14:23,746 --> 04:14:26,549 LOT OF COLLABORATIVE WORK GOING 5831 04:14:26,549 --> 04:14:27,583 ON BETWEEN THESE DATA 5832 04:14:27,583 --> 04:14:28,718 REPOSITORIES. REACH OUT TO ONE 5833 04:14:28,718 --> 04:14:32,021 OF THEM. REACH OUT TO THE AD 5834 04:14:32,021 --> 04:14:34,023 KNOWLEDGE PORTAL DISCUSSION 5835 04:14:34,023 --> 04:14:35,458 FORUM, POSE A QUESTION AND THEY 5836 04:14:35,458 --> 04:14:37,026 CAN HELP YOU NAVIGATE THIS 5837 04:14:37,026 --> 04:14:38,260 ECOSYSTEM. 5838 04:14:38,260 --> 04:14:39,962 >> THANK YOU. WITH THAT WE WANT 5839 04:14:39,962 --> 04:14:42,565 TO THANK OUR SESSION 7 SPEAKERS. 5840 04:14:42,565 --> 04:14:46,736 >> THANKS TO ALL THE SPEAKERS 5841 04:14:46,736 --> 04:14:48,070 AND THANK YOU TO THE AUDIENCE. 5842 04:14:48,070 --> 04:14:48,637 >> THANK YOU. 5843 04:14:48,637 --> 04:14:50,906 >> WE ARE GOING TO TAKE AN HOUR 5844 04:14:50,906 --> 04:14:52,608 BREAK FOR LUNCH, BUT BEFORE WE 5845 04:14:52,608 --> 04:14:54,944 DO, SARAH WOULD YOU LIKE TO 5846 04:14:54,944 --> 04:14:56,612 BRIEFLY TALK ABOUT THIS FLASH 5847 04:14:56,612 --> 04:14:58,114 SIGHT THAT IS UP? 5848 04:14:58,114 --> 04:15:00,649 >> ACTUALLY I JUST THANK YOU FOR 5849 04:15:00,649 --> 04:15:03,219 THE OPPORTUNITY TO MENTION THIS. 5850 04:15:03,219 --> 04:15:05,988 SO ANDY AND MYSELF AND CATHY ARE 5851 04:15:05,988 --> 04:15:09,225 SPECIAL EDITORS FOR -- I'M 5852 04:15:09,225 --> 04:15:11,327 SORRY, GUEST ED TOFERS FOR 5853 04:15:11,327 --> 04:15:14,029 SPECIAL INTERVIEW OF ALZHEIMER'S 5854 04:15:14,029 --> 04:15:16,499 DEMENTIA, WILL BE FOCUSED ON THE 5855 04:15:16,499 --> 04:15:18,868 40TH ANNIVERSARY OF ADRC PROGRAM 5856 04:15:18,868 --> 04:15:21,570 AND 25TH OF NAC. THE GOAL IS TO 5857 04:15:21,570 --> 04:15:23,572 HIGHLIGHT IMPACT THESE PROGRAMS 5858 04:15:23,572 --> 04:15:27,143 HAVE HAD ON ADVANCING ADRD 5859 04:15:27,143 --> 04:15:28,778 TRANSLATION DISCOVERY AND 5860 04:15:28,778 --> 04:15:29,545 ONGOING CLINICAL ROLE IN 5861 04:15:29,545 --> 04:15:31,147 TACKLING THE PRESSING CHALLENGES 5862 04:15:31,147 --> 04:15:32,415 IN THE FIELD MANY WHICH 5863 04:15:32,415 --> 04:15:33,582 DISCUSSED TODAY SO IF YOU ARE 5864 04:15:33,582 --> 04:15:35,017 INTERESTED IN SUBMITTING TO THE 5865 04:15:35,017 --> 04:15:37,019 OPEN CALL FOR THAT, THAT IS DUE 5866 04:15:37,019 --> 04:15:39,388 ON DECEMBER 31 AND WE THOUGHT IT 5867 04:15:39,388 --> 04:15:41,624 WOULD BE A BIG OPPORTUNITY, SO 5868 04:15:41,624 --> 04:15:43,926 MANY PEOPLE TALKED ABOUT USING 5869 04:15:43,926 --> 04:15:47,696 MAP DATA AS WELL AS OTHER ADRC 5870 04:15:47,696 --> 04:15:49,398 DATA, VERY INTERESTING WAYS AT 5871 04:15:49,398 --> 04:15:50,299 THIS CONFERENCE SO THANKS, 5872 04:15:50,299 --> 04:15:53,538 EVERYONE. 5873 04:15:56,000 --> 04:15:57,334 >> GOOD AFTERNOON, EVERYONE, 5874 04:15:57,334 --> 04:15:58,402 WELCOME TO THE NEAR FINAL 5875 04:15:58,402 --> 04:16:00,137 SESSION OF THIS ABSOLUTELY 5876 04:16:00,137 --> 04:16:00,904 FANTASTIC MEETING. 5877 04:16:00,904 --> 04:16:02,840 IT'S SUCH AN HONOR TO WITNESS 5878 04:16:02,840 --> 04:16:04,174 FIRSTHAND THE TRUE 5879 04:16:04,174 --> 04:16:06,343 TRANSFORMATION TAKING PLACE IN 5880 04:16:06,343 --> 04:16:08,112 THE FIELD OF ALZHEIMER'S DISEASE 5881 04:16:08,112 --> 04:16:09,513 THANKS ON THE PIONEERING EFFORTS 5882 04:16:09,513 --> 04:16:10,748 OF ALL OF YOU THAT HAVE BEEN 5883 04:16:10,748 --> 04:16:13,150 SHARED AT THIS GROUNDBREAKING 5884 04:16:13,150 --> 04:16:13,517 MEETING. 5885 04:16:13,517 --> 04:16:15,319 THESE LAST THREE DAYS HAVE MEANT 5886 04:16:15,319 --> 04:16:17,288 SO MUCH FOR ME ON MY JOURNEY, 5887 04:16:17,288 --> 04:16:18,922 THE LAST ALZHEIMER'S DISEASE 5888 04:16:18,922 --> 04:16:23,193 SUMMIT I ATTENDED WAS IN 2015 25 5889 04:16:23,193 --> 04:16:24,728 AND THE WORLD WAS A DIFFERENT 5890 04:16:24,728 --> 04:16:25,062 PLACE. 5891 04:16:25,062 --> 04:16:26,797 FOR MANY OF YOU WHO HAVE BEEN IN 5892 04:16:26,797 --> 04:16:28,799 THIS FIELD FOR SO LONG, YOU 5893 04:16:28,799 --> 04:16:30,000 REMEMBER IF YOU THINK BACK TO 5894 04:16:30,000 --> 04:16:31,935 TEN YEARS AGO, THE NAPA 5895 04:16:31,935 --> 04:16:33,604 INITIATIVE WAS JUST KICKING OFF, 5896 04:16:33,604 --> 04:16:36,240 THE BAPANUS TRIALS WERE JUST 5897 04:16:36,240 --> 04:16:40,811 READING OUT AND WE WERE 5898 04:16:40,811 --> 04:16:43,247 STARTING TO USE TERMS LIKE DATA 5899 04:16:43,247 --> 04:16:46,083 SHARING, BACK IN 2015. 5900 04:16:46,083 --> 04:16:49,386 TEN YEARS AGO, I WAS ASKED TO 5901 04:16:49,386 --> 04:16:50,888 WRITE A MANUSCRIPT AROUND MY 5902 04:16:50,888 --> 04:16:52,323 PERSONAL AND PROFESSIONAL 5903 04:16:52,323 --> 04:16:54,825 JOURNEY, AND IT WAS A CALL TO 5904 04:16:54,825 --> 04:16:57,161 ACTION PUBLISHED AS A 5905 04:16:57,161 --> 04:17:00,097 PERSPECTIVE REVIEW ENTITLED: 5906 04:17:00,097 --> 04:17:01,098 ALZHEIMER'S DISEASE, FROM 5907 04:17:01,098 --> 04:17:02,733 RESEARCHER TO CAREGIVER, A 5908 04:17:02,733 --> 04:17:04,935 PERSONAL JOURNEY AND CALL TO 5909 04:17:04,935 --> 04:17:05,169 ACTION. 5910 04:17:05,169 --> 04:17:06,370 THAT WAS WHEN MY MOTHER WAS 5911 04:17:06,370 --> 04:17:08,772 STILL ALIVE, AND STILL TO THIS 5912 04:17:08,772 --> 04:17:11,709 DAY, IT KEEPS ME UP AT NIGHT, 5913 04:17:11,709 --> 04:17:12,910 OFTENTIMES IN THE PAST FEELING 5914 04:17:12,910 --> 04:17:14,211 HOPELESS THAT I COULDN'T HELP 5915 04:17:14,211 --> 04:17:16,647 HER, BUT TODAY I'M JUST SO 5916 04:17:16,647 --> 04:17:17,514 INVIGORATED TO SEE THE PROGRESS 5917 04:17:17,514 --> 04:17:20,384 IN THIS FIELD AND TRULY HAVE 5918 04:17:20,384 --> 04:17:22,252 HOPE FOR THE FUTURE. 5919 04:17:22,252 --> 04:17:24,421 TODAY, WE GATHER IN THIS UNIQUE 5920 04:17:24,421 --> 04:17:27,157 SESSION TO FOCUS ON REGULATORY 5921 04:17:27,157 --> 04:17:31,428 SCIENCES, A TOPIC THAT IS SO 5922 04:17:31,428 --> 04:17:33,630 OVERLOOKED AND WAY TOO OFTEN 5923 04:17:33,630 --> 04:17:34,098 MISINTERPRETED. 5924 04:17:34,098 --> 04:17:36,567 SO WHAT DOES THE TERM REGULATORY 5925 04:17:36,567 --> 04:17:38,969 INNOVATION TRULY MEAN? 5926 04:17:38,969 --> 04:17:41,405 TODAY, IN THIS UNIQUE PANEL, YOU 5927 04:17:41,405 --> 04:17:44,575 WILL HEAR FROM DISTINGUISHED 5928 04:17:44,575 --> 04:17:45,976 LEADERS ACROSS DIFFERENT CENTERS 5929 04:17:45,976 --> 04:17:48,278 AND DIVISIONS AT THE FDA TO 5930 04:17:48,278 --> 04:17:51,281 SHARE THEIR INSIGHTS AND 5931 04:17:51,281 --> 04:17:51,582 EXAMPLES. 5932 04:17:51,582 --> 04:17:54,685 THE THEMES OF MODEL INFORMED 5933 04:17:54,685 --> 04:17:56,353 DRUG DEVELOPMENT, PATIENT 5934 04:17:56,353 --> 04:17:57,855 FOCUSED DRUG DEVELOPMENT, 5935 04:17:57,855 --> 04:17:59,289 COMPLEXIN NOTICE VAI TV TRIAL 5936 04:17:59,289 --> 04:18:01,024 DESIGNS, BIOMARKERS INCLUDING 5937 04:18:01,024 --> 04:18:02,793 REASONABLY LIKELY SURROGATE 5938 04:18:02,793 --> 04:18:05,295 ENDPOINTS, AND ACCELERATED 5939 04:18:05,295 --> 04:18:06,830 APPROVAL, WERE PIONEERED IN 5940 04:18:06,830 --> 04:18:09,233 NEARLY ALL CASES IN ALZHEIMER'S 5941 04:18:09,233 --> 04:18:11,201 DISEASE AT THE FDA. 5942 04:18:11,201 --> 04:18:13,637 SUCH NOVEL STRATEGIES HAVE PAVED 5943 04:18:13,637 --> 04:18:15,706 THE PATH IN THAT OTHER DISEASE 5944 04:18:15,706 --> 04:18:17,341 AREAS ARE FOLLOWING. 5945 04:18:17,341 --> 04:18:18,642 THE PRINCIPLES YOU WILL HEAR 5946 04:18:18,642 --> 04:18:21,278 ABOUT IN THIS SESSION ARE BEING 5947 04:18:21,278 --> 04:18:23,147 APPLIED ACROSS MANY DISORDERS, 5948 04:18:23,147 --> 04:18:24,882 INCLUDING RARE CHRONIC 5949 04:18:24,882 --> 04:18:26,550 PROGRESSIVE DISORDERS THAT ARE 5950 04:18:26,550 --> 04:18:29,586 HAVING APPROVALS FOR THE FIRST 5951 04:18:29,586 --> 04:18:29,920 TIME. 5952 04:18:29,920 --> 04:18:32,122 HOW UNPRECEDENTED IS THAT? 5953 04:18:32,122 --> 04:18:33,424 DETERMINING THE SAFETY AND 5954 04:18:33,424 --> 04:18:34,591 EFFECTIVENESS OF NEW MEDICATIONS 5955 04:18:34,591 --> 04:18:37,027 IS VERY, VERY HARD TO DO. 5956 04:18:37,027 --> 04:18:38,929 TWHEAN FROM MY YEARS THERE -- I 5957 04:18:38,929 --> 04:18:40,297 KNOW THAT FROM MY YEARS IN 5958 04:18:40,297 --> 04:18:41,365 INDUSTRY, BUT THE REGULATORY 5959 04:18:41,365 --> 04:18:43,066 SIDE OF THIS I THINK VERY FEW 5960 04:18:43,066 --> 04:18:45,335 APPRECIATE HOW DIFFICULT THIS 5961 04:18:45,335 --> 04:18:45,736 IS. 5962 04:18:45,736 --> 04:18:48,071 OUR AGENCY COLLEAGUES ARE 5963 04:18:48,071 --> 04:18:49,506 PARTNERS WITH US AT CRITICAL 5964 04:18:49,506 --> 04:18:51,341 PATH INSTITUTE, AND WE'RE SO 5965 04:18:51,341 --> 04:18:52,543 GRATEFUL FOR THE LONG TIME 5966 04:18:52,543 --> 04:18:54,978 SUPPORT AND FUNDING OF THE 5967 04:18:54,978 --> 04:18:59,016 NEARLY 20 YEARS SINCE CPATH WAS 5968 04:18:59,016 --> 04:18:59,349 FOUNDED. 5969 04:18:59,349 --> 04:19:01,952 IN ALZHEIMER'S DISEASE THE C 5970 04:19:01,952 --> 04:19:03,587 PATH COALITION AGAINST MAJOR 5971 04:19:03,587 --> 04:19:04,488 DISEASES WAS ONE OF THE FIRST TO 5972 04:19:04,488 --> 04:19:05,923 TAKE ON THE TASK OF SHARING 5973 04:19:05,923 --> 04:19:07,458 CLINICAL TRIAL DATA FROM 5974 04:19:07,458 --> 04:19:09,092 ALZHEIMER'S TRIALS MOST OF WHICH 5975 04:19:09,092 --> 04:19:12,596 HAD FAILED IN THEIR GOAL TO 5976 04:19:12,596 --> 04:19:13,163 ACHIEVE DISEASE-MODIFYING 5977 04:19:13,163 --> 04:19:13,430 ACTIVITY. 5978 04:19:13,430 --> 04:19:15,432 THIS DATA WAS USED TO ACHIEVE 5979 04:19:15,432 --> 04:19:19,503 THE FIRST-EVER IN SILICO DRUG 5980 04:19:19,503 --> 04:19:22,139 DISEASE TRIAL MODEL IN 2013. 5981 04:19:22,139 --> 04:19:24,208 THIS ACHIEVEMENT SET THE 5982 04:19:24,208 --> 04:19:25,108 LANDSCAPE OF WHAT YOU'RE GOING 5983 04:19:25,108 --> 04:19:27,845 TO HEAR ABOUT TODAY ON THE FDA'S 5984 04:19:27,845 --> 04:19:30,681 NEW QUANTITATIVE CENTER, 5985 04:19:30,681 --> 04:19:32,082 QUANTITATIVE MEDICINE CENTER OF 5986 04:19:32,082 --> 04:19:34,051 EXCELLENCE THAT YOU'RE GOING TO 5987 04:19:34,051 --> 04:19:34,718 HEAR OF. 5988 04:19:34,718 --> 04:19:37,354 WE ALSO ACHIEVED IN 2015 THE 5989 04:19:37,354 --> 04:19:39,656 FIRST EVER LETTER OF SUPPORT FOR 5990 04:19:39,656 --> 04:19:41,492 ALZHEIMER'S BIOMARKERS, WAY A 5991 04:19:41,492 --> 04:19:44,461 LONG TIME AGO WHEN IT WAS A BETA 5992 04:19:44,461 --> 04:19:49,800 AND CFS AND TAONCFS AND WE KNOW 5993 04:19:49,800 --> 04:19:50,701 HOW THAT'S BEEN TRANSFORMED TO 5994 04:19:50,701 --> 04:19:52,202 BLOOD BASED BIOMARKERS. 5995 04:19:52,202 --> 04:19:53,971 JUST A FEW WEEKS AGO, 5996 04:19:53,971 --> 04:19:55,272 FAST-FORWARD TO TODAY, THE FDA 5997 04:19:55,272 --> 04:19:57,274 JUST SIGNED A LETTER OF 5998 04:19:57,274 --> 04:19:59,676 SUPPORT,IC CHRISTINE MENTIONED 5999 04:19:59,676 --> 04:20:02,312 THIS, FOR THE USE OF CFSS OFFICE 6000 04:20:02,312 --> 04:20:04,281 NEW CLEE INTO SUPPORT CLINICAL 6001 04:20:04,281 --> 04:20:06,250 TRIALS OF DISORDERS THAT SHARE A 6002 04:20:06,250 --> 04:20:10,354 COMMON BIOLOGY OF SINUCLIIN, 6003 04:20:10,354 --> 04:20:12,256 THIS WAS A LANDMARK BECAUSE IT 6004 04:20:12,256 --> 04:20:13,657 TOOK ONLY THREE MONTHS AND SHOWS 6005 04:20:13,657 --> 04:20:15,225 THE URGENCY ACROSS DIVISIONS. 6006 04:20:15,225 --> 04:20:16,727 IN THIS SESSION, YOU WILL HEAR 6007 04:20:16,727 --> 04:20:19,229 FROM LEADERS AT THE CENTERS OF 6008 04:20:19,229 --> 04:20:22,733 EXCELLENCE IN MULTIPLE DIVISIONS 6009 04:20:22,733 --> 04:20:26,136 AND HOW THEY'RE APPROACHING AND 6010 04:20:26,136 --> 04:20:27,104 ADVANCING THERAPEUTIC INNOVATION 6011 04:20:27,104 --> 04:20:28,105 AND REGULATORY SCIENCE. 6012 04:20:28,105 --> 04:20:29,306 IT'S MY HOPE THAT YOU CAN 6013 04:20:29,306 --> 04:20:31,041 GENERATE IDEAS FROM THIS 6014 04:20:31,041 --> 04:20:32,576 DISCUSSION TODAY AND GENERATE 6015 04:20:32,576 --> 04:20:34,645 WAYS THAT YOU CAN WORK IN 6016 04:20:34,645 --> 04:20:36,747 PARTNERSHIP WITH THE AGENCY TO 6017 04:20:36,747 --> 04:20:37,814 ACCELERATE YOUR PROGRESS IN YOUR 6018 04:20:37,814 --> 04:20:39,049 OWN RESEARCH AND TRIALS. 6019 04:20:39,049 --> 04:20:47,357 THANK YOU. 6020 04:20:47,357 --> 04:20:49,526 JUST SPEAKING FOR THE FIRST 6021 04:20:49,526 --> 04:20:54,898 SPEAKER IN THE SESSION I THINK 6022 04:20:54,898 --> 04:21:05,609 IS DR. B DR. BU BURACCHIO. 6023 04:21:19,122 --> 04:21:26,563 >> I'M TERESA BURACCHIO, I'M THE 6024 04:21:26,563 --> 04:21:30,033 DIRECTOR OF NEUROSCIENCE IN THE 6025 04:21:30,033 --> 04:21:31,702 CENTER FOR DRUGS. 6026 04:21:31,702 --> 04:21:32,803 OTHER NEUROLOGIC DISEASES AS 6027 04:21:32,803 --> 04:21:34,004 WELL WHEN WE'RE TALKING ABOUT 6028 04:21:34,004 --> 04:21:40,777 PRECISION THERAPIES. 6029 04:21:40,777 --> 04:21:43,747 SO, THIS MANTRA, RIGHT DRUG SHES 6030 04:21:43,747 --> 04:21:45,415 RIGHT PERSON, RIGHT TIME, I HAVE 6031 04:21:45,415 --> 04:21:46,817 SEEN ON A COUPLE SLIDES HERE 6032 04:21:46,817 --> 04:21:48,352 ALREADY AND HAS BEEN AROUND FOR 6033 04:21:48,352 --> 04:21:49,920 WHILE, BUT I USE THIS AS 6034 04:21:49,920 --> 04:21:51,855 SHORTHAND A LOT WHEN I THINK 6035 04:21:51,855 --> 04:21:53,256 ABOUT PRECISION MEDICINE IS WHAT 6036 04:21:53,256 --> 04:21:54,257 DOES IT MEAN TO ME AT THE 6037 04:21:54,257 --> 04:21:55,692 AGENCY, AND THIS IS WHAT I 6038 04:21:55,692 --> 04:21:55,892 THINK. 6039 04:21:55,892 --> 04:21:57,427 I THINK ABOUT THE RIGHT DRUG, IS 6040 04:21:57,427 --> 04:22:02,599 IT TARGETING THE RIGHT TARGETS 6041 04:22:02,599 --> 04:22:04,234 IN THE PATHOLOGIC PROCESS OF THE 6042 04:22:04,234 --> 04:22:05,869 DISEASE, ARE WE TREATING A 6043 04:22:05,869 --> 04:22:07,604 PERSON WHO HAS THOSE TARGETS, 6044 04:22:07,604 --> 04:22:11,208 WHO MANIFESTS THOSE PATHOLOGIC 6045 04:22:11,208 --> 04:22:12,743 PROCESSES, IN ALMOST ALL OF OUR 6046 04:22:12,743 --> 04:22:13,744 NEUROLOGIC I GO DISEASES THE 6047 04:22:13,744 --> 04:22:16,013 RIGHT TIME IS AS SOON AS 6048 04:22:16,013 --> 04:22:17,214 POSSIBLE -- NEUROLOGIC DISEASES, 6049 04:22:17,214 --> 04:22:18,882 THE RIGHT TIME IS AS SOON AS 6050 04:22:18,882 --> 04:22:20,183 POSSIBLE IF NOT YESTERDAY. 6051 04:22:20,183 --> 04:22:21,952 SO WE WANT TO GO AS EARLY AS 6052 04:22:21,952 --> 04:22:22,219 POSSIBLE. 6053 04:22:22,219 --> 04:22:23,487 IT'S IMPORTANT TO NOTE, THOUGH, 6054 04:22:23,487 --> 04:22:25,455 THAT WE CAN ONLY ADDRESS THIS TO 6055 04:22:25,455 --> 04:22:27,991 SOME EXTENT IN DRUG DEVELOPMENT 6056 04:22:27,991 --> 04:22:29,826 AND APPROVING A DRUG IS ONLY THE 6057 04:22:29,826 --> 04:22:31,361 FIRST STEP IN THE PROCESS. 6058 04:22:31,361 --> 04:22:32,796 A LOT OF WHAT HAPPENS WITH 6059 04:22:32,796 --> 04:22:34,564 PRECISION MEDICINE HAPPENS AFTER 6060 04:22:34,564 --> 04:22:36,400 DRUG APPROVAL, AND WHEN WE SEE 6061 04:22:36,400 --> 04:22:38,935 HOW THE DRUG IS USED IN THE REAL 6062 04:22:38,935 --> 04:22:39,169 WORLD. 6063 04:22:39,169 --> 04:22:41,104 SO A LOT OF THE DISCUSSION THAT 6064 04:22:41,104 --> 04:22:42,873 IS WE'VE HAD TODAY ARE HOW TO 6065 04:22:42,873 --> 04:22:44,174 LEVERAGE DATA THAT'S ACCRUING 6066 04:22:44,174 --> 04:22:46,076 BOTH IN THE REAL WORLD AND 6067 04:22:46,076 --> 04:22:47,711 THROUGH RESEARCH STUDIES, SO 6068 04:22:47,711 --> 04:22:49,446 IT'S IMPORTANT TO UNDERSTAND HOW 6069 04:22:49,446 --> 04:22:51,181 TO APPLY THOSE PRINCIPLES EVEN 6070 04:22:51,181 --> 04:22:52,849 AFTER A DRUG IS APPROVED. 6071 04:22:52,849 --> 04:22:54,451 THERE'S ONLY SO MANY THINGS WE 6072 04:22:54,451 --> 04:22:55,719 CAN ACCOUNT FOR WITHIN THE 6073 04:22:55,719 --> 04:22:57,554 SETTING OF A CLINICAL TRIAL, BUT 6074 04:22:57,554 --> 04:22:59,189 WHEN IT GOES OUT, A DRUG GOES 6075 04:22:59,189 --> 04:23:00,757 OUT INTO THE REAL WORLD IS WHEN 6076 04:23:00,757 --> 04:23:02,192 WE REALLY START TO SEE HOW WE 6077 04:23:02,192 --> 04:23:05,228 CAN USE THESE DRUGS OPTIMALLY IN 6078 04:23:05,228 --> 04:23:10,467 THE CLINIC. 6079 04:23:10,467 --> 04:23:14,404 SO AS I MENTIONED, WE THINK 6080 04:23:14,404 --> 04:23:15,739 BROADLY AT THE AGENCY, ALTHOUGH 6081 04:23:15,739 --> 04:23:17,074 ALZHEIMER'S DISEASE IS A REALLY 6082 04:23:17,074 --> 04:23:18,909 LARGE PORTION OF OUR PORTFOLIO 6083 04:23:18,909 --> 04:23:20,110 WITHIN THE OFFICE OF 6084 04:23:20,110 --> 04:23:21,878 NEUROSCIENCE, WE SEE ALL 6085 04:23:21,878 --> 04:23:23,814 NEUROLOGIC DISEASES. 6086 04:23:23,814 --> 04:23:26,016 SO WE HAVE A LOT OF EXAMPLES OF 6087 04:23:26,016 --> 04:23:27,884 TARGETED THERAPIES IN NEUROLOGY, 6088 04:23:27,884 --> 04:23:30,721 AND THNTS AN EXHAUSTIVE LIST -- 6089 04:23:30,721 --> 04:23:32,889 THNTS AN EXHAUSTIVE LIST -- THIS 6090 04:23:32,889 --> 04:23:34,524 IS NOT AN EXHAUSTIVE LIST, IT'S 6091 04:23:34,524 --> 04:23:36,426 SOME OF THE MORE RECENT 6092 04:23:36,426 --> 04:23:36,960 APPROVALS. 6093 04:23:36,960 --> 04:23:38,395 ALZHEIMER'S DISEASE IS ONE OF 6094 04:23:38,395 --> 04:23:39,429 THE MORE RECENT APPROVALS THAT 6095 04:23:39,429 --> 04:23:41,264 WE'VE HAD IN A LONG LITANY OF 6096 04:23:41,264 --> 04:23:43,667 DRUGS OF TARGETED THERAPIES, AND 6097 04:23:43,667 --> 04:23:45,635 I'LL POINT OUT A FEW NOTABLE 6098 04:23:45,635 --> 04:23:46,837 ONES THAT I THINK HAVE BEEN 6099 04:23:46,837 --> 04:23:49,773 PRETTY EXCITING FOR US, WHICH IS 6100 04:23:49,773 --> 04:23:56,580 THE ALS SOD1 MUTATION WHICH IS 6101 04:23:56,580 --> 04:23:57,581 AN ANTI-SENSE AL GOA NUCLEOTIDE 6102 04:23:57,581 --> 04:24:03,587 THAT BINDS SOD1 mRNA AND SOD1 6103 04:24:03,587 --> 04:24:05,889 TROWKS GIVE AN ACCELERATED 6104 04:24:05,889 --> 04:24:06,990 APPROVAL TO THAT DRUG AND THAT 6105 04:24:06,990 --> 04:24:08,191 GOT A LOT OF PRESS AT THE TIME 6106 04:24:08,191 --> 04:24:10,393 AND IT WAS A PRETTY EXCITING 6107 04:24:10,393 --> 04:24:12,696 APPLICATION FOR US TO REVIEW AS 6108 04:24:12,696 --> 04:24:13,330 WELL. 6109 04:24:13,330 --> 04:24:15,766 AND ANOTHER JUST EXAMPLE OF A 6110 04:24:15,766 --> 04:24:18,268 TARGETED THERAPY THAT HAS HAD A 6111 04:24:18,268 --> 04:24:25,609 BIG EFFECT IS THE HEREDITARY 6112 04:24:25,609 --> 04:24:26,510 TRANCETHYRETEN-MEDIATED 6113 04:24:26,510 --> 04:24:27,844 AMYLOIDOSIS FOR POLYNEUROPATHY, 6114 04:24:27,844 --> 04:24:29,646 AN EXAMPLE WHERE WE'VE BEEN ABLE 6115 04:24:29,646 --> 04:24:31,748 TO HAVE A HIGH QUALITY BIOMARKER 6116 04:24:31,748 --> 04:24:33,483 THAT'S VERY RELIABLE AND 6117 04:24:33,483 --> 04:24:34,785 REDUCTIONS WERE REALLY 6118 04:24:34,785 --> 04:24:37,220 PREDICTIVE OF BENEFITS. 6119 04:24:37,220 --> 04:24:38,622 THAT RECEIVED A STANDARD 6120 04:24:38,622 --> 04:24:40,390 APPROVAL, NOT AN ACCELERATED 6121 04:24:40,390 --> 04:24:41,558 APPROVAL, BUT I THINK IT REALLY 6122 04:24:41,558 --> 04:24:43,426 SHOWED HOW A VERY TARGETED 6123 04:24:43,426 --> 04:24:45,829 THERAPY COULD HAVE A LARGE 6124 04:24:45,829 --> 04:24:46,830 IMPACT. 6125 04:24:46,830 --> 04:24:48,598 NOW, WE KNOW ALSO, THOUGH, THAT 6126 04:24:48,598 --> 04:24:51,368 DISEASES ARE COMPLEX, AND EVEN 6127 04:24:51,368 --> 04:24:55,005 THOUGH WE TARGET ONE PIECE OF 6128 04:24:55,005 --> 04:24:57,140 THE DISEASE, IT'S REALLY A PIECE 6129 04:24:57,140 --> 04:24:58,375 OF THE PUZZLE. 6130 04:24:58,375 --> 04:25:00,277 AND THERE'S A LOT, MANY OTHER 6131 04:25:00,277 --> 04:25:01,645 TARGETS THAT COULD BE TARGETED. 6132 04:25:01,645 --> 04:25:03,180 SO WE RECOGNIZE THAT IN A 6133 04:25:03,180 --> 04:25:04,915 SETTING OF ALZHEIMER'S DISEASE, 6134 04:25:04,915 --> 04:25:06,783 ALTHOUGH WE NOW HAVE SOME 6135 04:25:06,783 --> 04:25:08,652 AMYLOID TARGETED THERAPIES, THAT 6136 04:25:08,652 --> 04:25:09,820 THAT'S NOT GOING ON CURE THE 6137 04:25:09,820 --> 04:25:11,154 DISEASE AND WE NEED TO CONTINUE 6138 04:25:11,154 --> 04:25:13,557 TO UNDERSTAND OTHER TARGETS AS 6139 04:25:13,557 --> 04:25:13,890 WELL. 6140 04:25:13,890 --> 04:25:15,592 AND IT'S GOING TO BE, AND IT MAY 6141 04:25:15,592 --> 04:25:17,928 NOT JUST BE DRUGS THERE, MAY BE 6142 04:25:17,928 --> 04:25:21,131 OTHER MODIFIABLE FACTORS IN 6143 04:25:21,131 --> 04:25:22,432 LIFESTYLE THAT WILL ALSO COME 6144 04:25:22,432 --> 04:25:23,300 INTO PLAY. 6145 04:25:23,300 --> 04:25:25,735 SO WE DO RECOGNIZE THAT, AND, 6146 04:25:25,735 --> 04:25:28,572 YOU KNOW, IT'S NOT THAT THE 6147 04:25:28,572 --> 04:25:29,973 AMYLOID BETA DIRECTED ANTIBODIES 6148 04:25:29,973 --> 04:25:31,308 ARE GOING TO BE THE ANSWER, BUT 6149 04:25:31,308 --> 04:25:35,545 THEY'LL BE ONE PIECE OF THE 6150 04:25:35,545 --> 04:25:36,046 ANSWER. 6151 04:25:36,046 --> 04:25:39,182 SO WHAT IS CRITICAL FOR DRUG 6152 04:25:39,182 --> 04:25:40,917 DEVELOPMENT AND HAVING PRECISION 6153 04:25:40,917 --> 04:25:42,686 THERAPIES OR TARGETED THERAPIES 6154 04:25:42,686 --> 04:25:44,955 IS HAVING A BIOLOGIC BASED 6155 04:25:44,955 --> 04:25:47,924 DEFINITION OF A DISEASE, AND 6156 04:25:47,924 --> 04:25:49,459 THIS HAS REALLY ONLY BEEN 6157 04:25:49,459 --> 04:25:50,560 POSSIBLE IN THE LAST 20 YEARS OR 6158 04:25:50,560 --> 04:25:52,395 SO IN ALZHEIMER'S DISEASE WHEN 6159 04:25:52,395 --> 04:25:53,163 WE'VE HAD THE DEVELOPMENT 6160 04:25:53,163 --> 04:25:54,831 ACCURATE AND RELIABLE BIOMARKERS 6161 04:25:54,831 --> 04:25:56,233 THAT PROVIDE AN INCREASED 6162 04:25:56,233 --> 04:25:58,668 UNDERSTANDING OF THE DISEASE 6163 04:25:58,668 --> 04:26:00,837 PROCESSES IN VIVO. 6164 04:26:00,837 --> 04:26:03,673 AND MORE RECENTLY WEEIVEL ABLE 6165 04:26:03,673 --> 04:26:04,875 TO -- WE'VE BEEN ABLE TO MOVE 6166 04:26:04,875 --> 04:26:06,610 USING THESE BIOMARKERS FROM 6167 04:26:06,610 --> 04:26:08,278 DIAGNOSES BASED ON PHENOTYPE OR 6168 04:26:08,278 --> 04:26:09,713 CLINICAL SYMPTOMS TO DIAGNOSES 6169 04:26:09,713 --> 04:26:11,781 THAT ARE INFORMED BY ACTUAL 6170 04:26:11,781 --> 04:26:13,083 BIOMARKERS OF DISEASE PATHOLOGY 6171 04:26:13,083 --> 04:26:15,952 THAT WE CAN MEASURE IN LINE. 6172 04:26:15,952 --> 04:26:18,788 AND IT'S REALLY CRITICAL TO DRUG 6173 04:26:18,788 --> 04:26:19,689 DEVELOPMENT BECAUSE FOR A NUMBER 6174 04:26:19,689 --> 04:26:20,624 OF REASONS, AND I HIGHLIGHTED A 6175 04:26:20,624 --> 04:26:22,459 FEW OF THEM HERE, WHICH IS, YOU 6176 04:26:22,459 --> 04:26:25,228 KNOW, ALLOWS US FOR MORE PRECISE 6177 04:26:25,228 --> 04:26:26,429 DEFINITIONS OF DISEASE 6178 04:26:26,429 --> 04:26:27,764 POPULATIONS, IT FACILITATES THE 6179 04:26:27,764 --> 04:26:28,965 DEVELOPMENT OF TARGETED 6180 04:26:28,965 --> 04:26:30,267 THERAPIES, THE KEY PIECE OF THIS 6181 04:26:30,267 --> 04:26:32,869 IS REDUCING HETEROGENEITY IN 6182 04:26:32,869 --> 04:26:35,238 CLINICAL TRIALS, THE MORE 6183 04:26:35,238 --> 04:26:36,306 HOMOGENOUS WE CAN HAVE A 6184 04:26:36,306 --> 04:26:37,307 POPULATION, THE BETTER WE'LL BE 6185 04:26:37,307 --> 04:26:39,276 ABLE TO DEDUCT A SIGNAL, 6186 04:26:39,276 --> 04:26:40,343 ALTHOUGH AS I SAID WE DO 6187 04:26:40,343 --> 04:26:41,344 RECOGNIZE THAT WHEN THIS ROLLS 6188 04:26:41,344 --> 04:26:42,746 OUT INTO THE REAL WORLD, THERE 6189 04:26:42,746 --> 04:26:44,714 WILL BE MORE HETEROGENEITY THAT 6190 04:26:44,714 --> 04:26:46,816 WE'LL NEED TO UNDERSTAND. 6191 04:26:46,816 --> 04:26:49,653 IT'S INFORMATIVE TO PRESCRIBERS 6192 04:26:49,653 --> 04:26:51,087 TO IDENTIFY OPTIMAL THERAPIES 6193 04:26:51,087 --> 04:26:52,756 FOR PATIENTS, AND A CRITICAL 6194 04:26:52,756 --> 04:26:54,157 PIECE OF THIS IS THAT IT'S GOING 6195 04:26:54,157 --> 04:26:56,559 ON ALLOW US TO MOVE AS EARLY AS 6196 04:26:56,559 --> 04:26:58,094 POSSIBLE IN TREATING THESE 6197 04:26:58,094 --> 04:26:59,729 DISEASES AND IDEALLY I THINK WE 6198 04:26:59,729 --> 04:27:01,798 ALL WANT TO MOVE BEFORE SYMPTOMS 6199 04:27:01,798 --> 04:27:02,465 EVEN BEGIN. 6200 04:27:02,465 --> 04:27:07,771 WE WANT TO INTERVENE AS EARLY AS 6201 04:27:07,771 --> 04:27:08,271 POSSIBLE. 6202 04:27:08,271 --> 04:27:10,407 SO SOME EXAMPLES OF THIS IN 6203 04:27:10,407 --> 04:27:13,743 ALZHEIMER'S, WHICH I THINK 6204 04:27:13,743 --> 04:27:16,813 EVERYONE KNOWS ARE THE REVISED 6205 04:27:16,813 --> 04:27:18,148 CRITERIA FOR DIAGNOSING AND 6206 04:27:18,148 --> 04:27:24,054 STAGING PUBLISHED EARLY THIS 6207 04:27:24,054 --> 04:27:26,122 YEAR, AND IN BOTH OF THESE OUR 6208 04:27:26,122 --> 04:27:27,857 GUIDANCE IS ALIGNED VERY WELL 6209 04:27:27,857 --> 04:27:29,960 FOR THE CRITERIA FOR DIAGNOSIS 6210 04:27:29,960 --> 04:27:31,628 AND STAGE AND GO OUR GUIDANCE IS 6211 04:27:31,628 --> 04:27:34,130 BASED ON HAVING A BIOLOGIC BASED 6212 04:27:34,130 --> 04:27:36,333 DEFINITION OF DISEASE, WHICH IS 6213 04:27:36,333 --> 04:27:38,601 INFORMED BY BIOMARKERS, AS WELL 6214 04:27:38,601 --> 04:27:40,503 AS CLINICAL STAGING, AND IN OUR 6215 04:27:40,503 --> 04:27:42,038 GUIDANCE WE'RE ABLE TO, WE DO 6216 04:27:42,038 --> 04:27:46,076 GIVE SOME SPECIFIC OUTLINES FOR 6217 04:27:46,076 --> 04:27:47,610 WHAT DIFFERENT CLINICAL STAGES 6218 04:27:47,610 --> 04:27:48,912 OF DISEASE ARE. 6219 04:27:48,912 --> 04:27:51,114 WE DON'T ENDORSE ANY SPECIFIC 6220 04:27:51,114 --> 04:27:52,649 BIOMARKERS IN THE ALZHEIMER'S 6221 04:27:52,649 --> 04:27:54,050 DISEASE GUIDANCE BECAUSE WE 6222 04:27:54,050 --> 04:27:55,852 DOMENT IT TO BE FLEXIBLE AND WE 6223 04:27:55,852 --> 04:27:57,687 DO WANT IT TO BE ABLE TO BE 6224 04:27:57,687 --> 04:27:59,189 ADAPTABLE AND EVOLVE AS THE 6225 04:27:59,189 --> 04:28:00,957 SCIENCE EVOLVES, BUT THE 6226 04:28:00,957 --> 04:28:05,996 CLINICAL STAGING IS PRETTY WELL 6227 04:28:05,996 --> 04:28:06,896 UNDERSTOOD ALREADY BY THE 6228 04:28:06,896 --> 04:28:08,631 PUBLIC, SO WE DO HAVE THAT IN 6229 04:28:08,631 --> 04:28:09,466 OUR GUIDANCE. 6230 04:28:09,466 --> 04:28:12,469 BUT IT DOES OVERALL ALLOW FOR 6231 04:28:12,469 --> 04:28:14,537 TIE TO THE CURRENT REVISED 6232 04:28:14,537 --> 04:28:16,106 CRITERIA FOR DIAGNOSIS AND 6233 04:28:16,106 --> 04:28:17,273 STAGING OF ALZHEIMER'S DISEASE, 6234 04:28:17,273 --> 04:28:20,010 AND IT ALSO ALLOWS AS THOSE 6235 04:28:20,010 --> 04:28:21,678 CRITERIA TO EVOLVE AND GROW 6236 04:28:21,678 --> 04:28:25,348 SWINE TISK KNOWLEDGE THAT OUR 6237 04:28:25,348 --> 04:28:25,982 GUIDE -- SCIENTIFIC KNOWLEDGE 6238 04:28:25,982 --> 04:28:28,885 THAT OUR GUIDANCE WILL ALLOW FOR 6239 04:28:28,885 --> 04:28:29,652 THAT. 6240 04:28:29,652 --> 04:28:33,223 IT'S IMPORTANT TO NOTE THAT THIS 6241 04:28:33,223 --> 04:28:35,692 IS ALSO HAPPENING IN OTHER 6242 04:28:35,692 --> 04:28:36,693 NEURODEGENERATIVE DISEASES AS 6243 04:28:36,693 --> 04:28:37,961 WELL, SO THERE ARE INTEGRATED 6244 04:28:37,961 --> 04:28:39,496 STAGING SYSTEMS THAT HAVE BEEN 6245 04:28:39,496 --> 04:28:40,630 PROPOSED FOR HUNTINGTON'S 6246 04:28:40,630 --> 04:28:46,503 DISEASE AND MOST RECENTLY FOR 6247 04:28:46,503 --> 04:28:49,672 NEURONALLING SYNUCL HE IN 6248 04:28:49,672 --> 04:28:51,107 DISEASE WHICH INCLUDES 6249 04:28:51,107 --> 04:28:53,109 PARKINSON'S WITH NEURO BODIES 6250 04:28:53,109 --> 04:28:57,047 AND WE FIND THESE STAGING ARE 6251 04:28:57,047 --> 04:28:59,149 VERY USEFUL TO US TO HELP US 6252 04:28:59,149 --> 04:29:00,650 GIVE ADVICE ON DRUG DEVELOPMENT 6253 04:29:00,650 --> 04:29:03,720 AND HELPS US COME UP WITH COMMON 6254 04:29:03,720 --> 04:29:05,688 LANGUAGE THAT WHEN WE TALK WITH 6255 04:29:05,688 --> 04:29:07,991 ACADEMIA, WITH INDUSTRY, WITH 6256 04:29:07,991 --> 04:29:09,025 ADVOCACY GROUPS AND OTHER 6257 04:29:09,025 --> 04:29:09,859 GOVERNMENT AGENCIES AS WELL, 6258 04:29:09,859 --> 04:29:11,094 THAT WE KNOW THE POPULATION THAT 6259 04:29:11,094 --> 04:29:12,295 WE'RE TALKING ABOUT THAT WAS 6260 04:29:12,295 --> 04:29:14,030 ENROLLED IN THE CLINICAL TRIALS, 6261 04:29:14,030 --> 04:29:17,300 AND THEN WE KNOW HOW TO INFORM 6262 04:29:17,300 --> 04:29:19,069 PRESCRIBERS LATER ON HOW TO 6263 04:29:19,069 --> 04:29:21,805 OPTIMALLY USE THOSE, USE THE 6264 04:29:21,805 --> 04:29:23,406 DEFINITIONS THAT WERE USED IN 6265 04:29:23,406 --> 04:29:25,208 THE CLINICAL TRIALS AND CLINICAL 6266 04:29:25,208 --> 04:29:26,009 PRACTICE. 6267 04:29:26,009 --> 04:29:28,578 SO THESE GUIDELINES OR THESE 6268 04:29:28,578 --> 04:29:30,346 STAGING SYSTEMS ARE REALLY A 6269 04:29:30,346 --> 04:29:32,749 BRIDGE BETWEEN RESEARCH AND 6270 04:29:32,749 --> 04:29:34,384 CLINICAL PRACTICE, AND EVEN IF 6271 04:29:34,384 --> 04:29:36,352 CLINICAL PRACTICE ISN'T THERE 6272 04:29:36,352 --> 04:29:38,755 YET, AS WE DEVELOP NEW DRUGS AND 6273 04:29:38,755 --> 04:29:40,290 THE SCIENCE EVOLVES, CLINICAL 6274 04:29:40,290 --> 04:29:41,291 PRACTICE WILL GET THERE. 6275 04:29:41,291 --> 04:29:43,526 SO THESE ARE REALLY FORWARD 6276 04:29:43,526 --> 04:29:44,828 LOOKING DOCUMENTS, BUT WHAT IS 6277 04:29:44,828 --> 04:29:46,496 THE FUTURE IN CLINICAL PRACTICE 6278 04:29:46,496 --> 04:29:48,298 IS SORT OF OUR CURRENT TIME IN 6279 04:29:48,298 --> 04:29:49,399 DRUG DEVELOPMENT RIGHT NOW. 6280 04:29:49,399 --> 04:29:52,335 SO THESE ARE, I CONSIDER THEM 6281 04:29:52,335 --> 04:29:55,305 ESSENTIAL FOR THE WORK THAT WE 6282 04:29:55,305 --> 04:29:56,306 DO. 6283 04:29:56,306 --> 04:29:57,407 NOW, THERE ARE A LOT OF 6284 04:29:57,407 --> 04:29:59,142 DIFFERENT USES OF BIOMARKERS IN 6285 04:29:59,142 --> 04:30:00,677 DRUG DEVELOPMENT, AND I LISTED 6286 04:30:00,677 --> 04:30:02,846 THE MAIN USES THAT WE SEE HERE. 6287 04:30:02,846 --> 04:30:05,582 THERE'S A LOT OF FOCUS ON 6288 04:30:05,582 --> 04:30:06,683 SURROGATE ENDPOINTS AS PRIMARY 6289 04:30:06,683 --> 04:30:08,351 END POITS, AND THAT'S A PRETTY 6290 04:30:08,351 --> 04:30:09,886 HIGH BAR. 6291 04:30:09,886 --> 04:30:11,488 BUT I THINK BIOMARKERS CAN BE 6292 04:30:11,488 --> 04:30:13,456 USED IN ANY STAGE OF DEVELOPMENT 6293 04:30:13,456 --> 04:30:15,325 REALLY, AND WE FIND THEM 6294 04:30:15,325 --> 04:30:17,393 INFORMATIVE FOR A VARIETY OF 6295 04:30:17,393 --> 04:30:17,827 PURPOSES. 6296 04:30:17,827 --> 04:30:20,263 FOR INDUSTRY, PROOF CONCEPT IS 6297 04:30:20,263 --> 04:30:21,931 WHERE THEY COME IN A LOT, AND 6298 04:30:21,931 --> 04:30:23,233 THAT'S MAYBE A LITTLE LESS 6299 04:30:23,233 --> 04:30:24,767 IMPORTANT FOR US BECAUSE THAT 6300 04:30:24,767 --> 04:30:25,635 USUALLY HAPPENS AT THE STAGE 6301 04:30:25,635 --> 04:30:27,170 BEFORE THEY COME AND ENGAGE WITH 6302 04:30:27,170 --> 04:30:30,340 US AT THE AGENCY. 6303 04:30:30,340 --> 04:30:33,309 BUT DIAGNOSTIC BIOMARKERS ARE 6304 04:30:33,309 --> 04:30:35,912 USED FOR ENROLLMENT IN CLINICAL 6305 04:30:35,912 --> 04:30:36,579 TRIALS, FOR ENRICHMENT IN 6306 04:30:36,579 --> 04:30:37,680 POPULATIONS THAT ARE MORE LIKELY 6307 04:30:37,680 --> 04:30:38,982 TO PROGRESS OR DEVELOP THE 6308 04:30:38,982 --> 04:30:42,352 OUTCOME OF INTEREST DURING A 6309 04:30:42,352 --> 04:30:43,586 TRIAL, FOR MONITORING FOR 6310 04:30:43,586 --> 04:30:44,687 SAFETY, AND THEN OF COURSE THERE 6311 04:30:44,687 --> 04:30:47,190 IS THE SURROGATE ENDPOINT BUT 6312 04:30:47,190 --> 04:30:49,159 ALSO WE DO CONSIDER BIOMARKER AS 6313 04:30:49,159 --> 04:30:50,894 WELL WHEN WE'RE LOOKING AT 6314 04:30:50,894 --> 04:30:51,995 CLINICAL OUTCOME MEASURES, SO 6315 04:30:51,995 --> 04:30:54,430 THEY CAN BE SUPPORTIVE AND SHOW 6316 04:30:54,430 --> 04:30:56,299 UP ON A DYNAMIC RESPONSE THAT IS 6317 04:30:56,299 --> 04:30:57,901 SUPPORTIVE OF ANY IMPACT WE SEE 6318 04:30:57,901 --> 04:31:01,504 ON CLINICAL OUTCOME MEASURES. 6319 04:31:01,504 --> 04:31:03,373 DID I WANT TO HIGHLIGHT TWO 6320 04:31:03,373 --> 04:31:04,240 IMPORTANT THINGS THAT HAVE 6321 04:31:04,240 --> 04:31:05,675 ALREADY BEEN DISCUSSED. 6322 04:31:05,675 --> 04:31:07,644 DIANE MENTIONED ONE ABOUT WE 6323 04:31:07,644 --> 04:31:09,512 RECENTLY ISSUED A LETTER OF 6324 04:31:09,512 --> 04:31:13,550 SUPPORT ENCOURAGING THE USE OF 6325 04:31:13,550 --> 04:31:16,052 SYNUCLEAN BASED BIOMARKERS, THE 6326 04:31:16,052 --> 04:31:18,788 ASSAY IN CLINICAL TRIALS RISK OF 6327 04:31:18,788 --> 04:31:20,657 SUSCEPTIBILITY BIOMARKER AND 6328 04:31:20,657 --> 04:31:22,792 ALSO WITHIN NIH WE HAVE ACCEPTED 6329 04:31:22,792 --> 04:31:24,928 A LETTER OF INTENT TO QUALIFY 6330 04:31:24,928 --> 04:31:27,897 NEURO FILAMENT AS A BIOMARKER OF 6331 04:31:27,897 --> 04:31:29,299 RARE NEURODEGENERATIVE DISEASES. 6332 04:31:29,299 --> 04:31:30,166 THIS REALLY HIGHLIGHTS THE 6333 04:31:30,166 --> 04:31:31,834 IMPORTANT ROLES THAT 6334 04:31:31,834 --> 04:31:33,269 PUBLIC/PRIVATE PARTNERSHIPS AND 6335 04:31:33,269 --> 04:31:34,437 DATA SHARING AND ALL OF THE 6336 04:31:34,437 --> 04:31:36,105 GREAT THINGS WE HEARD ABOUT 6337 04:31:36,105 --> 04:31:38,174 EARLIER IN THE LAST SESSION H 6338 04:31:38,174 --> 04:31:40,109 THE IMPORTANCE OF THESE TO US AT 6339 04:31:40,109 --> 04:31:43,213 THE FDA TO DRUG DEVELOPMENT AT 6340 04:31:43,213 --> 04:31:45,415 LARGE, THAT WE CAN, YOU KNOW, 6341 04:31:45,415 --> 04:31:47,317 THESE ARE THINGS THAT YES, WE 6342 04:31:47,317 --> 04:31:52,555 CAN ACCEPT NEURO FILAMENT AND 6343 04:31:52,555 --> 04:31:54,624 CLINICAL TRIALS WITHOUT 6344 04:31:54,624 --> 04:31:55,825 NECESSARILY HAVING THESE 6345 04:31:55,825 --> 04:31:58,895 INITIATIVES UNDERWAY, BUT I 6346 04:31:58,895 --> 04:32:00,296 THINK THIS IS -- IT'S A LOT MORE 6347 04:32:00,296 --> 04:32:01,631 WORK FOR US AND FOR EVERYBODY 6348 04:32:01,631 --> 04:32:04,067 ELSE IF WE'RE DOING THESE ALL IN 6349 04:32:04,067 --> 04:32:05,902 SILOS, SO HAVING THESE SORT OF 6350 04:32:05,902 --> 04:32:06,970 PUBLIC/PRIVATE PARTNERSHIPS, 6351 04:32:06,970 --> 04:32:08,004 HAVING THESE INITIATIVES WHERE 6352 04:32:08,004 --> 04:32:10,306 PEOPLE ARE WORKING TOGETHER 6353 04:32:10,306 --> 04:32:11,708 REALLY HELPS MOVE THE FIELD AND 6354 04:32:11,708 --> 04:32:12,909 BRINGS EVERYBODY ALONG WITH IT 6355 04:32:12,909 --> 04:32:14,677 AND MAKES OUR JOB A LITTLE BIT 6356 04:32:14,677 --> 04:32:16,879 EASIER TOO. 6357 04:32:16,879 --> 04:32:19,382 I ALSO WANT TO HIGHLIGHT THE 6358 04:32:19,382 --> 04:32:21,351 IMPORTANCE OF DIVERSE 6359 04:32:21,351 --> 04:32:21,651 POPULATIONS. 6360 04:32:21,651 --> 04:32:23,953 WE REALLY, YOU KNOW, PRECISION 6361 04:32:23,953 --> 04:32:27,056 MEDICINE NEEDS TO CONSIDER THE 6362 04:32:27,056 --> 04:32:28,124 POPULATIONS THAT WE'LL BE USING 6363 04:32:28,124 --> 04:32:29,759 WITH DRUGS P IN THE REAL WORLD. 6364 04:32:29,759 --> 04:32:31,961 OFTEN OUR CLINICAL TRIALS ARE 6365 04:32:31,961 --> 04:32:33,596 LIMITED TO, YOU KNOW, PEOPLE WHO 6366 04:32:33,596 --> 04:32:35,231 ARE WILLING TO PARTICIPATE IN 6367 04:32:35,231 --> 04:32:37,333 CLINICAL TRIALS, SO THERE'S AN 6368 04:32:37,333 --> 04:32:38,434 INHERENT SELECTION BIAS THERE, 6369 04:32:38,434 --> 04:32:40,503 BUT WE REALLY NEED TO UNDERSTAND 6370 04:32:40,503 --> 04:32:44,440 HOW BIOMARKERS PERFORM IN A REAL 6371 04:32:44,440 --> 04:32:46,075 WORLD POPULATION, AND WE DO HAVE 6372 04:32:46,075 --> 04:32:48,044 A GUIDANCE THAT I HIGHLIGHTED 6373 04:32:48,044 --> 04:32:48,478 HERE. 6374 04:32:48,478 --> 04:32:50,113 IT'S NOT CURRENTLY A REQUIREMENT 6375 04:32:50,113 --> 04:32:52,315 BUT WE DO ASK COMPANIES, WE 6376 04:32:52,315 --> 04:32:54,050 RECOMMEND THAT THEY DEVELOP A 6377 04:32:54,050 --> 04:32:56,019 DIVERSITY ACTION PLAN TO IMPROVE 6378 04:32:56,019 --> 04:32:58,121 ENROLLMENT AND PARTICIPANTS FROM 6379 04:32:58,121 --> 04:32:59,122 UNDERREPRESENTED POPULATIONS AND 6380 04:32:59,122 --> 04:33:00,757 CLINICAL STUDIES, AND THIS MAY 6381 04:33:00,757 --> 04:33:02,725 BE INFORMATIVE FOR CLINICAL 6382 04:33:02,725 --> 04:33:07,330 RESEARCH BEYOND JUST CLINICAL 6383 04:33:07,330 --> 04:33:07,563 TRIALS. 6384 04:33:07,563 --> 04:33:08,765 I ALSO WANT TO HIGHLIGHT SOME 6385 04:33:08,765 --> 04:33:10,266 RECENT COLLABORATIVE WORK WE'VE 6386 04:33:10,266 --> 04:33:15,305 HAD WITH THE NIA, MY OUTSTANDING 6387 04:33:15,305 --> 04:33:17,173 COLLEAGUES HERE, SUZANNA AND 6388 04:33:17,173 --> 04:33:19,075 LAURA AND NADA ARE IN THE 6389 04:33:19,075 --> 04:33:21,678 EXPROOM WE WORK -- IN THE ROOM 6390 04:33:21,678 --> 04:33:23,313 AND WE CLOSELY WITH THEM. 6391 04:33:23,313 --> 04:33:24,947 ABOUT A YEAR AGO WE HAD A 6392 04:33:24,947 --> 04:33:25,715 COLLABORATIVE MEETING AND THOSE 6393 04:33:25,715 --> 04:33:27,583 OF US WHO WORK IN THE 6394 04:33:27,583 --> 04:33:28,451 ALZHEIMER'S DISEASE SPACE CAME 6395 04:33:28,451 --> 04:33:29,919 TOGETHER AND DISCUSSED COMMON 6396 04:33:29,919 --> 04:33:31,087 CHALLENGES WE'RE FACING BOTH IN 6397 04:33:31,087 --> 04:33:32,322 RESEARCH AND DRUG DEVELOPMENT 6398 04:33:32,322 --> 04:33:34,057 AND EARLIER THIS YEAR WE 6399 04:33:34,057 --> 04:33:35,692 EXECUTED A MEMORANDUM OF 6400 04:33:35,692 --> 04:33:37,327 UNDERSTANDING BETWEEN NIA AND 6401 04:33:37,327 --> 04:33:41,297 FDA AND SPECIFICALLY WITH CD HE 6402 04:33:41,297 --> 04:33:44,467 R AND CBER AND CDRH AND THIS 6403 04:33:44,467 --> 04:33:45,568 WILL ALLOW US TO DISCUSS 6404 04:33:45,568 --> 04:33:46,769 RESEARCH PRIORITIES ACROSS THE 6405 04:33:46,769 --> 04:33:48,671 AGENCY AND WILL FURTHER 6406 04:33:48,671 --> 04:33:49,539 FACILITATE COLLABORATION AND 6407 04:33:49,539 --> 04:33:50,940 WE'RE HAVING ONGOING DISCUSSIONS 6408 04:33:50,940 --> 04:33:52,275 ABOUT MORE COLLABORATIVE 6409 04:33:52,275 --> 04:33:54,577 INTERACTIONS TO COME. 6410 04:33:54,577 --> 04:33:56,512 SO I'LL WRAP IT UP HERE WITH THE 6411 04:33:56,512 --> 04:33:59,148 TAKE HOME POINTS THAT WE FEEL 6412 04:33:59,148 --> 04:34:00,583 THAT BIOLOGIC BASED DEFINITIONS 6413 04:34:00,583 --> 04:34:02,418 OF DISEASE ARE REALLY CRITICAL 6414 04:34:02,418 --> 04:34:03,519 FOR DRUG DEVELOPMENT. 6415 04:34:03,519 --> 04:34:05,488 THEY ALLOW FOR MORE PRECISE 6416 04:34:05,488 --> 04:34:06,923 CHARACTERIZATION OF DISEASE 6417 04:34:06,923 --> 04:34:07,990 POPULATIONS, AND IT'S IMPORTANT 6418 04:34:07,990 --> 04:34:11,627 THAT THE FRAMEWORKS TO DEFINE 6419 04:34:11,627 --> 04:34:13,563 END STAGE DISEASES FOR 6420 04:34:13,563 --> 04:34:14,464 STANDARDIZATION THAT THEY ARE 6421 04:34:14,464 --> 04:34:16,065 FLEXIBLE AND ALLOW FOR ADDITION 6422 04:34:16,065 --> 04:34:18,000 AND IS REVISIONS AS SCIENTIFIC 6423 04:34:18,000 --> 04:34:20,603 KNOWLEDGE EVOLVES, AND WE DO 6424 04:34:20,603 --> 04:34:22,705 FOLLOW THOSE, FOLLOW 9 SCIENCE 6425 04:34:22,705 --> 04:34:24,774 AND MAKE SURE THAT WE'RE AWARE 6426 04:34:24,774 --> 04:34:26,476 OF ALL THE LATEST THINKING ON, 6427 04:34:26,476 --> 04:34:29,145 YOU KNOW, HOW TO DEFINE AND 6428 04:34:29,145 --> 04:34:31,347 STAGE DISEASES, THAT INCLUSION 6429 04:34:31,347 --> 04:34:32,949 OF DIVERSE POPULATIONS IS 6430 04:34:32,949 --> 04:34:35,818 ESSENTIAL, AND KEY POINT HERE, 6431 04:34:35,818 --> 04:34:36,786 PRE-COMPETITIVE EFFORTS AND DATA 6432 04:34:36,786 --> 04:34:39,188 SHARING ARE CRITICAL TO SUCCESS 6433 04:34:39,188 --> 04:34:40,323 IN THIS SPACE. 6434 04:34:40,323 --> 04:34:50,500 THANK YOU. 6435 04:35:17,493 --> 04:35:27,503 >> 6436 04:35:39,449 --> 04:35:41,951 >> SORRY, WE'RE LOOKING FOR THE 6437 04:35:41,951 --> 04:35:45,588 FDA SLIDES ON QUANTITATIVE 6438 04:35:45,588 --> 04:35:46,422 MEDICINE, CENTER OF EXCELLENCE. 6439 04:35:46,422 --> 04:35:47,523 HERE WE ARE. 6440 04:35:47,523 --> 04:35:49,625 THE NEXT ONE AFTER THIS. 6441 04:35:49,625 --> 04:35:51,127 HERE WE ARE. 6442 04:35:51,127 --> 04:35:52,995 INTRODUCTION TO CD HE R 6443 04:35:52,995 --> 04:35:55,731 QUANTITATIVE MEDICINE CENTER OF 6444 04:35:55,731 --> 04:35:59,802 EXCELLENCE. 6445 04:35:59,802 --> 04:36:00,002 OKAY. 6446 04:36:00,002 --> 04:36:00,970 >> THANK YOU VERY MUCH. 6447 04:36:00,970 --> 04:36:03,673 THANK YOU, EVERYONE, FOR GIVING 6448 04:36:03,673 --> 04:36:06,509 US AN OPPORTUNITY TO COME AND 6449 04:36:06,509 --> 04:36:10,246 SHARE WITH YOU ALL ONE OF THE 6450 04:36:10,246 --> 04:36:13,516 RECENT CDER INITIATIVES, C DE R 6451 04:36:13,516 --> 04:36:15,818 QUANTITATIVE MEDICINE CENTER OF 6452 04:36:15,818 --> 04:36:17,019 EXCELLENCE. 6453 04:36:17,019 --> 04:36:21,090 CDER. 6454 04:36:21,090 --> 04:36:21,958 ALL RIGHT. 6455 04:36:21,958 --> 04:36:24,227 IT DID MOVE. 6456 04:36:24,227 --> 04:36:26,095 OKAY. 6457 04:36:26,095 --> 04:36:27,630 WELL, I THINK THERE ARE A NUMBER 6458 04:36:27,630 --> 04:36:28,631 OF DIFFERENT DEFINITIONS THAT 6459 04:36:28,631 --> 04:36:32,468 ARE OUT THERE FOR WHAT IS 6460 04:36:32,468 --> 04:36:33,135 QUANTITATIVE MEDICINE. 6461 04:36:33,135 --> 04:36:35,404 OUR OPERATING DEFINITION IS THAT 6462 04:36:35,404 --> 04:36:37,473 THIS INVOLVES DEVELOPMENT AND 6463 04:36:37,473 --> 04:36:40,343 APPLICATION OF EXPOSURE-BASED 6464 04:36:40,343 --> 04:36:45,147 MODELS THAT ARE ROOTED IN OUR 6465 04:36:45,147 --> 04:36:48,317 UNDERSTANDING OF BIOLOGY AND 6466 04:36:48,317 --> 04:36:51,053 PHYSIOLOGY AND USE THE 6467 04:36:51,053 --> 04:36:52,488 QUANTITATIVE METHOD TO USE THIS 6468 04:36:52,488 --> 04:36:53,589 INFORMATION ACROSS WIDE VARIETY 6469 04:36:53,589 --> 04:36:56,292 OF SOURCES OF INFORMATION, 6470 04:36:56,292 --> 04:36:58,060 COMING FROM NONCLINICAL, 6471 04:36:58,060 --> 04:36:59,128 CLINICAL, ALL THE WAY UP TO REAL 6472 04:36:59,128 --> 04:36:59,695 WORLD DATA. 6473 04:36:59,695 --> 04:37:00,997 THE PURPOSE OF DOING THIS 6474 04:37:00,997 --> 04:37:05,268 EXERCISE IS TO INFORM DRUG 6475 04:37:05,268 --> 04:37:07,003 DEVELOPMENT AND MORE 6476 04:37:07,003 --> 04:37:08,104 IMPORTANT -- REGULATORY DECISION 6477 04:37:08,104 --> 04:37:09,038 MAKE AND GO MORE IMPORTANTLY AT 6478 04:37:09,038 --> 04:37:10,506 THE END OF THE DAY, INFORM THE 6479 04:37:10,506 --> 04:37:10,973 PATIENT CARE. 6480 04:37:10,973 --> 04:37:12,275 IN OUR OPINION, WE HAVE SEEN 6481 04:37:12,275 --> 04:37:15,545 DOING THIS HELPS STREAMLINE P 6482 04:37:15,545 --> 04:37:17,313 AND ACCELERATE DRUG DEVELOPMENT 6483 04:37:17,313 --> 04:37:18,614 THROUGH ALL THE PRODUCT LIFE 6484 04:37:18,614 --> 04:37:18,848 CYCLE. 6485 04:37:18,848 --> 04:37:21,150 DURING THE PREMARKET STAGE, IT'S 6486 04:37:21,150 --> 04:37:24,086 USEFUL FOR IDENTIFYING AND 6487 04:37:24,086 --> 04:37:26,389 QUANTIFYING UNCERTAINTIES AND 6488 04:37:26,389 --> 04:37:28,024 HELP ADDRESS THOSE UNCERTAINTIES 6489 04:37:28,024 --> 04:37:31,093 IN THE LIFE CYCLE, AND MOST 6490 04:37:31,093 --> 04:37:34,363 IMPORTANTLY IN REGULATORY MAKING 6491 04:37:34,363 --> 04:37:36,032 SPACE, CONTRIBUTE TO THE 6492 04:37:36,032 --> 04:37:37,433 TOTALITY OF UNDERSTANDING OF A 6493 04:37:37,433 --> 04:37:40,002 DRUG'S BENEFITS AND RISKS. 6494 04:37:40,002 --> 04:37:42,138 WE HAVE HAD A RICH HISTORY OF 6495 04:37:42,138 --> 04:37:43,339 APPLICATION OF QUANTITATIVE 6496 04:37:43,339 --> 04:37:46,943 MEDICINE APPROACHES AT CDER. 6497 04:37:46,943 --> 04:37:48,945 HERE ARE FIVE OF THE EXAMPLES, 6498 04:37:48,945 --> 04:37:51,881 I'M PRETTY SURE THERE ARE A LOT 6499 04:37:51,881 --> 04:37:52,415 MORE. 6500 04:37:52,415 --> 04:37:54,283 I'LL TOUCH BRIEFLY ON SEVERAL OF 6501 04:37:54,283 --> 04:37:54,517 THESE. 6502 04:37:54,517 --> 04:37:56,152 SPHIRTS MODEL INFORMED DRUG 6503 04:37:56,152 --> 04:37:56,552 DEVELOPMENT. 6504 04:37:56,552 --> 04:37:58,554 -- FIRST IS MODEL INFORMED DRUG 6505 04:37:58,554 --> 04:37:59,188 DEVELOPMENT. 6506 04:37:59,188 --> 04:38:00,523 THIS INITIATIVE HAS BEEN AROUND 6507 04:38:00,523 --> 04:38:04,560 FOR CLOSE TO TWO DECADES BUT SIX 6508 04:38:04,560 --> 04:38:06,095 AND SEVEN IT WAS IDENTIFIED AS 6509 04:38:06,095 --> 04:38:10,366 ONE OF THE ENHANCEMENTS AS PART 6510 04:38:10,366 --> 04:38:12,101 OF -- AND WE HAVE A REGULATORY 6511 04:38:12,101 --> 04:38:14,437 ENGAGEMENT PATHWAY FOR APPLYING 6512 04:38:14,437 --> 04:38:16,272 MODEL INFORMED APPROACHES FOR 6513 04:38:16,272 --> 04:38:20,009 VARIOUS DRUG DEVELOPMENT 6514 04:38:20,009 --> 04:38:20,376 DECISION-MAKING. 6515 04:38:20,376 --> 04:38:22,645 SECOND IS COMPLEXIN NOTICE 6516 04:38:22,645 --> 04:38:24,180 VAITIVE TRIAL DESIGN, THIS IS A 6517 04:38:24,180 --> 04:38:25,681 PROGRAM ALONG WITH MODEL 6518 04:38:25,681 --> 04:38:26,582 INFORMED DRUG DEVELOPMENT AT THE 6519 04:38:26,582 --> 04:38:28,117 OFFICE OF CLINICAL PHARMACOLOGY, 6520 04:38:28,117 --> 04:38:30,152 RUN OUT OF THE OFFICE OF 6521 04:38:30,152 --> 04:38:31,687 STATISTICS, PRIMARILY FOCUSING 6522 04:38:31,687 --> 04:38:35,091 VERY COMPLEX AND INNOVATIVE 6523 04:38:35,091 --> 04:38:38,060 TRIALS WHICH INVOLVE ADAPTIVE 6524 04:38:38,060 --> 04:38:39,895 DESIGNS, YOU NAME IT, ALL THESE 6525 04:38:39,895 --> 04:38:44,634 UNIQUE FEATURES, IT BE ABLE TO 6526 04:38:44,634 --> 04:38:46,035 BEST LEVERAGE THE TRIALS TO BE 6527 04:38:46,035 --> 04:38:47,236 ABLE TO INFORM THE DRUG 6528 04:38:47,236 --> 04:38:47,637 DEVELOPMENT. 6529 04:38:47,637 --> 04:38:48,437 THE THIRD AND PROBABLY MORE 6530 04:38:48,437 --> 04:38:49,639 RELEVANT TO THIS PARTICULAR 6531 04:38:49,639 --> 04:38:51,841 AUDIENCE THE FIT FOR PURPOSE 6532 04:38:51,841 --> 04:38:53,142 INITIATIVE, A JOINT PROGRAM RUN 6533 04:38:53,142 --> 04:38:56,746 OUT BY THE OFFICE OF CLINICAL 6534 04:38:56,746 --> 04:38:58,180 PHARMACOLOGY, IN COLLABORATION 6535 04:38:58,180 --> 04:39:02,652 WITH THE OFFICE OF NEW -- 6536 04:39:02,652 --> 04:39:04,987 WHEREIN VARIOUS APPROACHES, 6537 04:39:04,987 --> 04:39:06,922 EITHER TECHNICAL APPROACHES FOR 6538 04:39:06,922 --> 04:39:09,892 CONDUCTING DATA ANALYSIS OR FOR 6539 04:39:09,892 --> 04:39:11,394 DEVELOPING DISEASE PROGRESSION 6540 04:39:11,394 --> 04:39:13,696 MODELS FOR SPECIFIC APPLICATIONS 6541 04:39:13,696 --> 04:39:16,599 THAT ARE DEEMED TO BE FIT FOR 6542 04:39:16,599 --> 04:39:18,300 APPLICATION IN A SPECIFIC 6543 04:39:18,300 --> 04:39:18,534 CONTEXT. 6544 04:39:18,534 --> 04:39:20,836 ONE OF THE EXAMPLES THAT WE HAVE 6545 04:39:20,836 --> 04:39:24,874 UNDER THIS IS IN THE ALZHEIMER'S 6546 04:39:24,874 --> 04:39:26,942 DISEASE FOR INFORMING CLINICAL 6547 04:39:26,942 --> 04:39:30,479 TRIALS USING SIMULATION 6548 04:39:30,479 --> 04:39:31,547 APPROACHES. 6549 04:39:31,547 --> 04:39:33,215 THESE ARE ALL WHAT I MENTIONED 6550 04:39:33,215 --> 04:39:34,850 ARE IN THE NEW DRUG SPACE. 6551 04:39:34,850 --> 04:39:36,819 WE ALSO HAVE SIMILAR EFFORTS OF 6552 04:39:36,819 --> 04:39:38,788 APPLICATION OF QUANTITATIVE 6553 04:39:38,788 --> 04:39:39,789 APPROACHES IN THE LIFE CYCLE 6554 04:39:39,789 --> 04:39:41,957 SPACE, IN OUR OFFICE OF 6555 04:39:41,957 --> 04:39:43,392 GENERATIVE DRUGS WHERE THEY HAVE 6556 04:39:43,392 --> 04:39:46,662 A SPECIFIC PROGRAM FOR MODEL 6557 04:39:46,662 --> 04:39:48,097 INTEGRATED EVIDENCE WHERE 6558 04:39:48,097 --> 04:39:51,267 MODELING APPROACHES ARE USED FOR 6559 04:39:51,267 --> 04:39:52,568 BIOAVAILABILITY, IN VERY COMPLEX 6560 04:39:52,568 --> 04:39:53,803 SITUATIONS WHERE YOU CANNOT 6561 04:39:53,803 --> 04:39:57,406 CONDUCT THE ROUTINE CLINICAL 6562 04:39:57,406 --> 04:39:59,575 STUDIES THAT INFORM THE APPROVAL 6563 04:39:59,575 --> 04:40:04,180 OF GENERATIVE PRODUCTS. 6564 04:40:04,180 --> 04:40:08,384 SIMILARLY BEING IN THE OFFICE OE 6565 04:40:08,384 --> 04:40:11,087 OF QUALITY, THERE'S BEEN 6566 04:40:11,087 --> 04:40:12,988 PHYSICIAN LOGICS BASED MODELING 6567 04:40:12,988 --> 04:40:14,290 APPROACHES TO BE ABLE TO HELP 6568 04:40:14,290 --> 04:40:16,692 INFORM THE PRODUCT QUALITY, 6569 04:40:16,692 --> 04:40:17,993 INFORMING THIS SPECIFICATIONS 6570 04:40:17,993 --> 04:40:20,196 UPON RELEASE AND THINGS OF THAT 6571 04:40:20,196 --> 04:40:20,763 NATURE. 6572 04:40:20,763 --> 04:40:23,365 SO THIS IS NOT NEW IN A SENSE, 6573 04:40:23,365 --> 04:40:25,101 EVEN THOUGH WE ARE USING NEW 6574 04:40:25,101 --> 04:40:26,535 TERMS HERE. 6575 04:40:26,535 --> 04:40:28,604 SO GIVEN THIS KIND OF A RICH 6576 04:40:28,604 --> 04:40:31,474 HISTORY, WE THOUGHT WE ARE IN 6577 04:40:31,474 --> 04:40:33,109 VERY INTERESTING TIMES WHERE WE 6578 04:40:33,109 --> 04:40:36,212 CAN BRING ALL THESE EFFORTS TO 6579 04:40:36,212 --> 04:40:39,014 BE ABLE TO ACTUALLY MAKE MUCH 6580 04:40:39,014 --> 04:40:40,316 PROGRESS TO LEARN FROM ONE 6581 04:40:40,316 --> 04:40:41,951 ANOTHER, AND THAT WAS THE 6582 04:40:41,951 --> 04:40:47,823 MOTIVATION FOR US TO COME UP 6583 04:40:47,823 --> 04:40:50,493 WITH THE CDER QUANTITATIVE 6584 04:40:50,493 --> 04:40:51,694 MEDICINE CENTER FOR EXCELLENCE. 6585 04:40:51,694 --> 04:40:53,028 THE VARIOUS FOCUS AREAS WHICH I 6586 04:40:53,028 --> 04:40:54,330 HAVE MENTIONED HERE ARE THE ONES 6587 04:40:54,330 --> 04:40:56,699 WHERE WE WOULD COME TOGETHER TO 6588 04:40:56,699 --> 04:40:58,701 COORDINATE, COLLABORATE AND 6589 04:40:58,701 --> 04:40:59,502 OPERATIONALIZE APPLICATION OF 6590 04:40:59,502 --> 04:41:03,606 MANY OF THESE APPROACHES, 6591 04:41:03,606 --> 04:41:05,274 APPLYING PHARMACOSTATISTICAL 6592 04:41:05,274 --> 04:41:07,009 MODELS, MECHANISTIC MODELING, 6593 04:41:07,009 --> 04:41:09,078 MACHINE LEARNING AND ARTIFICIAL 6594 04:41:09,078 --> 04:41:10,312 INTELLIGENCE, YOU HAVE HEARD 6595 04:41:10,312 --> 04:41:11,514 ABOUT THAT THIS MORNING, THIS IS 6596 04:41:11,514 --> 04:41:13,182 THE THING THAT IS UP AND COMING 6597 04:41:13,182 --> 04:41:15,451 ADDING TO THE TOOLKIT OF 6598 04:41:15,451 --> 04:41:16,585 QUANTITATIVE RESEARCH THAT WE 6599 04:41:16,585 --> 04:41:19,355 HAVE, APPLYING THEN FOR BETTER 6600 04:41:19,355 --> 04:41:21,357 UNDERSTANDING OF BIOMARKER 6601 04:41:21,357 --> 04:41:25,261 ENDPOINT RELATIONSHIPS, 6602 04:41:25,261 --> 04:41:28,264 DR. BURACCHIO TALKED ABOUT 6603 04:41:28,264 --> 04:41:29,565 BIOMARKERS IN THE SPAN OF NEW 6604 04:41:29,565 --> 04:41:30,866 DRUG DEVELOPMENT AND LASTLY TO 6605 04:41:30,866 --> 04:41:33,402 BE ABLE TO APPLY THESE MODELS TO 6606 04:41:33,402 --> 04:41:36,038 ANTICIPATE HOW TO, HOW WOULD THE 6607 04:41:36,038 --> 04:41:39,975 TRIALS PLAY OUT IF WE WERE TO 6608 04:41:39,975 --> 04:41:42,144 RUN IN SILICO PREDICTIONS OF 6609 04:41:42,144 --> 04:41:43,379 THOSE SO WE ARE BETTER INFORMED 6610 04:41:43,379 --> 04:41:44,513 WITH RESPECT TO WHAT INFORMATION 6611 04:41:44,513 --> 04:41:45,981 TO COLLECT, WHEN TO COLLECT AND 6612 04:41:45,981 --> 04:41:47,616 HOW TO ACTUALLY DESIGN THESE 6613 04:41:47,616 --> 04:41:50,152 TRIALS AND OPERATIONALIZE THEM. 6614 04:41:50,152 --> 04:41:51,353 SO WE BELIEVE WITH THE 6615 04:41:51,353 --> 04:41:53,656 ESTABLISHMENT OF THE CDER 6616 04:41:53,656 --> 04:41:55,090 QUANTITATIVE MEDICINE CENTER OF 6617 04:41:55,090 --> 04:41:57,059 EXCELLENCE, WE WILL HELP 6618 04:41:57,059 --> 04:41:59,562 FACILITATE CONTINUOUS EVOLUTION 6619 04:41:59,562 --> 04:42:01,831 CONSISTENT APPLICATION OF 6620 04:42:01,831 --> 04:42:02,965 APPROACHES FOR DRUG DEVELOPMENT 6621 04:42:02,965 --> 04:42:05,034 AND REGULATORY DECISION-MAKING. 6622 04:42:05,034 --> 04:42:07,536 THIS EFFORT BRINGS TOGETHER FIVE 6623 04:42:07,536 --> 04:42:09,972 DIFFERENT SUPER OFFICES WITHIN 6624 04:42:09,972 --> 04:42:13,509 THE CENTER -- CD HE R OFFICES, 6625 04:42:13,509 --> 04:42:16,779 WITH SPONSORSHIP COMING FROM OUR 6626 04:42:16,779 --> 04:42:19,081 CENTER DIRECTOR, AND IT PULLS IN 6627 04:42:19,081 --> 04:42:22,685 ALL THE RELEVANT DISCIPLINES 6628 04:42:22,685 --> 04:42:25,321 ENGAGED IN THE NEW DRUG SPACE, 6629 04:42:25,321 --> 04:42:27,957 AS WELL AS IN THE LIFE CYCLE, 6630 04:42:27,957 --> 04:42:31,460 RANGING FROM OFFICE OF 6631 04:42:31,460 --> 04:42:32,862 TRANSLATIONAL SCIENCES WITH 6632 04:42:32,862 --> 04:42:33,963 OFFICE BIOSTATISTICS AND OFFICE 6633 04:42:33,963 --> 04:42:37,700 OF CLINICAL PHARMACOLOGY, OFFICE 6634 04:42:37,700 --> 04:42:41,403 OF NEW DRUG POLICY, QUALITY 6635 04:42:41,403 --> 04:42:42,838 RESEARCH AS WELL AS QUALITY 6636 04:42:42,838 --> 04:42:44,440 ASSESSMENTS, AND LASTLY FROM THE 6637 04:42:44,440 --> 04:42:46,108 OFFICE OF GENERIC DRUGS WITH THE 6638 04:42:46,108 --> 04:42:46,775 OFFICE OF RESEARCH STANDARDS. 6639 04:42:46,775 --> 04:42:49,845 SO THIS PROVIDES AN OPPORTUNITY 6640 04:42:49,845 --> 04:42:51,513 TO PULL TOGETHER THE EFFORTS 6641 04:42:51,513 --> 04:42:53,682 THAT ARE ACROSS ALL THESE 6642 04:42:53,682 --> 04:42:56,752 OFFICES TO BE ABLE TO 6643 04:42:56,752 --> 04:42:57,820 COORDINATE, COLLABORATE AND 6644 04:42:57,820 --> 04:43:01,023 LEARN FROM ONE ANOTHER AND BE 6645 04:43:01,023 --> 04:43:04,193 ABLE TO OPERATIONALIZE MANY OF 6646 04:43:04,193 --> 04:43:06,729 THESE CONCEPTS FOR CONSISTENT 6647 04:43:06,729 --> 04:43:10,599 APPLICATION THROUGHOUT THE 6648 04:43:10,599 --> 04:43:10,866 LANDSCAPE. 6649 04:43:10,866 --> 04:43:13,702 SO THE PRIMARY FOCUS. 6650 04:43:13,702 --> 04:43:15,871 CDER QUANTITATIVE MEDICINE 6651 04:43:15,871 --> 04:43:16,438 CENTER OF EXCELLENCE CAN BE 6652 04:43:16,438 --> 04:43:17,773 BUCKETED INTO THESE THREE MAIN 6653 04:43:17,773 --> 04:43:19,141 AREAS AND I'LL TALK THROUGH EACH 6654 04:43:19,141 --> 04:43:20,542 ONE OF THESE VERY QUICKLY. 6655 04:43:20,542 --> 04:43:21,710 THE FIRST IS WITH APPLIED 6656 04:43:21,710 --> 04:43:23,112 SCIENCE POLICY. 6657 04:43:23,112 --> 04:43:25,648 SO WE HAVE GATHERED A LOT OF 6658 04:43:25,648 --> 04:43:27,283 EXPERIENCE AND COMFORT LEVEL 6659 04:43:27,283 --> 04:43:31,020 WITH APPLICATION OF QUANTITATIVE 6660 04:43:31,020 --> 04:43:32,655 APPROACHES IN DIFFERENT AREAS, 6661 04:43:32,655 --> 04:43:35,257 WHICH CAN HELP US FOSTER 6662 04:43:35,257 --> 04:43:36,692 DEVELOPMENT OF GOOD PRACTICES 6663 04:43:36,692 --> 04:43:40,329 WHICH ARE EVIDENCE-BASED AND TO 6664 04:43:40,329 --> 04:43:43,499 HELP INFORM NEW GUIDANCES, WHICH 6665 04:43:43,499 --> 04:43:45,567 WILL IN TURN HELP WITH THE 6666 04:43:45,567 --> 04:43:49,738 CONSISTENT APPLICATION OF 6667 04:43:49,738 --> 04:43:50,039 APPROACHES. 6668 04:43:50,039 --> 04:43:51,907 WE'LL ALSO BE EMBARKING UPON 6669 04:43:51,907 --> 04:43:53,142 KNOWLEDGE MANAGEMENT WHICH 6670 04:43:53,142 --> 04:43:55,778 INVOLVES CATALOGING VARIOUS 6671 04:43:55,778 --> 04:43:57,746 PRECEDENCES WHICH BECOME THE 6672 04:43:57,746 --> 04:43:59,048 SUBSTRATES FOR EVENTUAL 6673 04:43:59,048 --> 04:44:00,683 DEVELOPMENT OF POLICIES AS WE 6674 04:44:00,683 --> 04:44:02,451 DID FORWARD AND BE ABLE TO 6675 04:44:02,451 --> 04:44:04,086 DISSEMINATE THIS SO THAT WE CAN 6676 04:44:04,086 --> 04:44:07,489 RAISE THE AWARENESS OF THE 6677 04:44:07,489 --> 04:44:08,223 APPLICABILITY OF THESE 6678 04:44:08,223 --> 04:44:09,792 APPROACHES AND IN WHICH CONTEXT 6679 04:44:09,792 --> 04:44:11,093 THEY MIGHT BE USEFUL, AND THAT 6680 04:44:11,093 --> 04:44:12,728 CONNECTS TO THE SECOND FOCUS 6681 04:44:12,728 --> 04:44:14,663 AREA, WHICH IS MULTIDISCIPLINARY 6682 04:44:14,663 --> 04:44:16,198 EDUCATION AND EXCHANGE. 6683 04:44:16,198 --> 04:44:19,268 THE FIRST IS THE EDUCATIONAL 6684 04:44:19,268 --> 04:44:19,835 ENRICHMENT. 6685 04:44:19,835 --> 04:44:21,470 THE EFFORTS HERE IS TO BE ABLE 6686 04:44:21,470 --> 04:44:24,306 TO MAKE SURE THAT THE LEARNINGS 6687 04:44:24,306 --> 04:44:27,276 ARE MADE AVAILABLE TONT ONLY 6688 04:44:27,276 --> 04:44:28,477 STAFF -- TO NOT ONLY STAFF 6689 04:44:28,477 --> 04:44:30,679 WITHIN THE CENTER BUT ALSO THE 6690 04:44:30,679 --> 04:44:33,148 VARIOUS STAKEHOLDERS SO THAT 6691 04:44:33,148 --> 04:44:35,384 THERE IS AN INCREASED AWARENESS 6692 04:44:35,384 --> 04:44:36,585 ABOUT THE AVAILABILITY OF 6693 04:44:36,585 --> 04:44:38,087 VARIOUS APPROACHES, WHEN THEY 6694 04:44:38,087 --> 04:44:40,422 CAN BE USEFUL TO BE APPLIED, AND 6695 04:44:40,422 --> 04:44:42,925 WHAT ARE THE PROS AND CONS OF 6696 04:44:42,925 --> 04:44:44,960 SPECIFIC APPLICATIONS. 6697 04:44:44,960 --> 04:44:47,429 AND TO THIS END, WE'LL ALSO BE 6698 04:44:47,429 --> 04:44:48,197 ENGAGING WITH THE COMMUNITY 6699 04:44:48,197 --> 04:44:53,435 THROUGH STAKEHOLDER ENGAGEMENT 6700 04:44:53,435 --> 04:44:54,436 ACTIVITIES WHEREIN WE'RE TRYING 6701 04:44:54,436 --> 04:44:58,073 TO LEARN FROM THE PEOPLE ON THE 6702 04:44:58,073 --> 04:44:59,141 OUTSIDE, ACOMPLYING IS 6703 04:44:59,141 --> 04:45:00,442 DEVELOPING SOME OF THESE 6704 04:45:00,442 --> 04:45:02,211 APPROACHES TO BE ABLE TO BE 6705 04:45:02,211 --> 04:45:05,981 PREPARED FOR THE FUTURE WHERE WE 6706 04:45:05,981 --> 04:45:08,117 WILL BE -- AS PART OF SUBMISSION 6707 04:45:08,117 --> 04:45:09,752 SO WE CAN HAVE AN INFORMED 6708 04:45:09,752 --> 04:45:10,419 DIALOGUE. 6709 04:45:10,419 --> 04:45:12,488 LASTLY, THIS IS PREDOMINANTLY AN 6710 04:45:12,488 --> 04:45:13,255 IN-HOUSE ACTIVITY WITH RESPECT 6711 04:45:13,255 --> 04:45:14,890 TO STRATEGIC PLANNING AND 6712 04:45:14,890 --> 04:45:16,091 COORDINATION, SO WE ARE 6713 04:45:16,091 --> 04:45:17,426 CURRENTLY IN THE PROCESS OF 6714 04:45:17,426 --> 04:45:19,261 PULLING TOGETHER ALL THE VARIOUS 6715 04:45:19,261 --> 04:45:22,698 ACTIVITIES THAT ARE HAPPENING 6716 04:45:22,698 --> 04:45:24,867 ACROSS DIFFERENT OFFICES AND PUT 6717 04:45:24,867 --> 04:45:26,769 FORTH A PLAN FOR COORDINATING 6718 04:45:26,769 --> 04:45:28,504 ALL THESE EFFORTS AS WE GO 6719 04:45:28,504 --> 04:45:29,038 FORWARD. 6720 04:45:29,038 --> 04:45:30,939 SO I HOPE THIS PROVIDES A HIGH 6721 04:45:30,939 --> 04:45:33,075 LEVEL OVERVIEW OF THE CENTER AND 6722 04:45:33,075 --> 04:45:34,443 THE FOCUS AREAS, AND BEFORE I 6723 04:45:34,443 --> 04:45:35,711 CLOSE, I WOULD LIKE TO TOUCH UP 6724 04:45:35,711 --> 04:45:38,914 ON SOME OF THE KEY HIGHLIGHTS OF 6725 04:45:38,914 --> 04:45:40,549 THE OPPORTUNITIES FOR 6726 04:45:40,549 --> 04:45:42,551 QUANTITATIVE MEDICINE APPROACHES 6727 04:45:42,551 --> 04:45:44,386 IN ADVANCING NEW THERAPIES 6728 04:45:44,386 --> 04:45:46,688 ESPECIALLY IN THIS AREA OF 6729 04:45:46,688 --> 04:45:48,257 NEURODEGENERATIVE DISEASES. 6730 04:45:48,257 --> 04:45:50,192 I THINK THERE IS GOING TO BE 6731 04:45:50,192 --> 04:45:53,028 SOME OVERLAP IN WHAT 6732 04:45:53,028 --> 04:45:54,763 DR. BURACCHIO PRESENTED. 6733 04:45:54,763 --> 04:45:56,098 THE QUANTITATIVE MEDICINE 6734 04:45:56,098 --> 04:45:57,666 APPROACHES CAN BE VERY USEFUL IN 6735 04:45:57,666 --> 04:45:59,201 UNDERSTANDING THE PROGRESSION OF 6736 04:45:59,201 --> 04:46:02,237 DISEASE AND ALSO VARIOUS SOURCES 6737 04:46:02,237 --> 04:46:04,873 OF AVAILABILITY TO BE ABLE TO 6738 04:46:04,873 --> 04:46:06,742 IDENTIFY -- OF VARIABILITY TO BE 6739 04:46:06,742 --> 04:46:07,943 ABLE TO IDENTIFY AND HELP 6740 04:46:07,943 --> 04:46:08,877 ADDRESS THEM. 6741 04:46:08,877 --> 04:46:11,180 THE SECOND ASPECT IS AROUND 6742 04:46:11,180 --> 04:46:12,815 IDENTIFICATION OF BIOMARKERS AND 6743 04:46:12,815 --> 04:46:13,682 CHARACTERIZING THEIR 6744 04:46:13,682 --> 04:46:14,583 RELATIONSHIPS WITH THE ENDPOINTS 6745 04:46:14,583 --> 04:46:15,284 OF INTEREST. 6746 04:46:15,284 --> 04:46:16,752 SOMETIMES THESE ARE PROGNOSTIC 6747 04:46:16,752 --> 04:46:18,187 IN NATURE, SOMETIMES THEY ARE 6748 04:46:18,187 --> 04:46:20,055 PREDICTIVE IN NATURE, BUT I 6749 04:46:20,055 --> 04:46:23,325 THINK FUNDAMENTALLY WE WILL HAVE 6750 04:46:23,325 --> 04:46:24,760 ESPECIALLY IN AREAS WHERE THESE 6751 04:46:24,760 --> 04:46:26,095 ARE SLOW MOVING OR SLOWLY 6752 04:46:26,095 --> 04:46:28,063 PROGRESSING AREAS, THAT IT IS 6753 04:46:28,063 --> 04:46:29,898 ESSENTIAL FOR US TO BE ABLE TO 6754 04:46:29,898 --> 04:46:32,568 HAVE A GOOD UNDERSTANDINGS OF 6755 04:46:32,568 --> 04:46:35,737 VARIOUS MARKERS AND THE PATHWAY 6756 04:46:35,737 --> 04:46:37,139 AND HOW THEY ARE RELATED TO ONE 6757 04:46:37,139 --> 04:46:38,707 ANOTHER TO BE ABLE TONT ONLY 6758 04:46:38,707 --> 04:46:40,008 TARGET THOSE, BUT ALSO TO BE 6759 04:46:40,008 --> 04:46:42,177 ABLE TO MEASURE -- TO NOT ONLY 6760 04:46:42,177 --> 04:46:43,178 TARGET THOSE BUT ALSO TO BE ABLE 6761 04:46:43,178 --> 04:46:45,147 TO MEASURE AND USE THEM TO 6762 04:46:45,147 --> 04:46:47,249 IDENTIFY TREATMENT OR EVEN 6763 04:46:47,249 --> 04:46:47,950 INFORM PATIENT SELECTION, WHICH 6764 04:46:47,950 --> 04:46:50,619 COMES TO THE NEXT POINT, WHERE 6765 04:46:50,619 --> 04:46:52,187 QUANTITATIVE MEDICINE APPROACHES 6766 04:46:52,187 --> 04:46:54,356 CAN BE VERY USEFUL FOR INFORMING 6767 04:46:54,356 --> 04:46:56,425 CLINICAL TRIAL DESIGN, 6768 04:46:56,425 --> 04:46:57,192 ENRICHMENT, IDENTIFYING THE 6769 04:46:57,192 --> 04:46:59,728 RIGHT PATIENTS WHO MIGHT BENEFIT 6770 04:46:59,728 --> 04:47:02,197 FROM THE TREATMENT. 6771 04:47:02,197 --> 04:47:05,734 ONE OF THE RIGHT -- ON WHAT 6772 04:47:05,734 --> 04:47:09,238 DR. BURACCHIO ADDED, FIND THE 6773 04:47:09,238 --> 04:47:10,772 RIGHT PATIENT AND AT THE RIGHT 6774 04:47:10,772 --> 04:47:11,206 TIME. 6775 04:47:11,206 --> 04:47:12,641 SO QUANTITATIVE MEDICINE 6776 04:47:12,641 --> 04:47:14,710 APPROACHES ARE OFTEN USEFUL FOR 6777 04:47:14,710 --> 04:47:15,878 INFORMING THOSE SELECTION. 6778 04:47:15,878 --> 04:47:17,880 THEY CAN BE VERY USEFUL FOR 6779 04:47:17,880 --> 04:47:19,414 INFORMING THE ENDPOINT SELECTION 6780 04:47:19,414 --> 04:47:21,817 AS WELL AS TIMING OF ASSESSMENTS 6781 04:47:21,817 --> 04:47:26,221 DEPENDING UPON THE TRAJECT RIDS 6782 04:47:26,221 --> 04:47:27,322 OF RESPONSE EFFORTS AS WELL AS 6783 04:47:27,322 --> 04:47:28,423 TREATMENT EFFORTS AND LASTLY 6784 04:47:28,423 --> 04:47:30,492 OFTEN USED FOR OPTIMIZING DOSE, 6785 04:47:30,492 --> 04:47:32,027 DOSING REGIMENS, BRIDGING 6786 04:47:32,027 --> 04:47:34,763 BETWEEN PRESENTATIONS, MIGHT 6787 04:47:34,763 --> 04:47:36,965 COME WITH FROM ONE DRUG ROUTE OF 6788 04:47:36,965 --> 04:47:37,966 ADMINISTRATION, IF THEY WERE TO 6789 04:47:37,966 --> 04:47:40,102 CHANGE FOR OTHER ROUTES OF 6790 04:47:40,102 --> 04:47:41,770 ADMINISTRATIONS, THESE 6791 04:47:41,770 --> 04:47:43,405 APPROACHES BRING IN A CERTAIN 6792 04:47:43,405 --> 04:47:45,140 ELEMENT OF EFFICIENCY SUCH THAT 6793 04:47:45,140 --> 04:47:46,475 WE CAN LEVERAGE IF OUR 6794 04:47:46,475 --> 04:47:47,643 UNDERSTANDING FROM PREVIOUS 6795 04:47:47,643 --> 04:47:52,381 EFFORTS TO BE ABLE TO HELP 6796 04:47:52,381 --> 04:47:53,615 INFORM THESE MODIFICATIONS. 6797 04:47:53,615 --> 04:47:56,585 SO LASTLY, BEFORE I CLOSE, I 6798 04:47:56,585 --> 04:47:58,854 WOULD POINT OUT SEVERAL 6799 04:47:58,854 --> 04:48:00,389 RESOURCES THAT ARE OUT THERE, 6800 04:48:00,389 --> 04:48:02,457 THE QUANTITATIVE MEDICINE CENTER 6801 04:48:02,457 --> 04:48:03,258 OF EXCELLENCE, AS WELL AS OUR 6802 04:48:03,258 --> 04:48:04,560 CONTACT INFORMATION, SO IF YOU 6803 04:48:04,560 --> 04:48:05,761 HAVE A GOOD IDEA AND YOU ARE 6804 04:48:05,761 --> 04:48:06,828 INTERESTED IN REACHING OUT TO 6805 04:48:06,828 --> 04:48:08,830 US, THAT COULD BE THE INBOX, AND 6806 04:48:08,830 --> 04:48:15,270 WE ALSO HAVE A SUITE OF 6807 04:48:15,270 --> 04:48:16,505 EDUCATIONAL RESOURCES THAT WE 6808 04:48:16,505 --> 04:48:18,373 WORK CLOSELY WITH THE CRITICAL 6809 04:48:18,373 --> 04:48:21,443 PATH INSTITUTE TO MAKE THEM 6810 04:48:21,443 --> 04:48:22,978 ONLINE, THIS IS THE CONTENT THAT 6811 04:48:22,978 --> 04:48:28,116 IS AVAILABLE ON OUR WEBSITE AND 6812 04:48:28,116 --> 04:48:29,952 ALSO INFORMATION FOR HEARING 6813 04:48:29,952 --> 04:48:31,153 ABOUT VARIOUS PRIORITIES AND 6814 04:48:31,153 --> 04:48:32,821 OPPORTUNITIES HA WE SHOULD 6815 04:48:32,821 --> 04:48:34,556 PROBABLY START THINKING ABOUT 6816 04:48:34,556 --> 04:48:45,100 AND PRIORITIZE AS WE GO FORWARD. 6817 04:48:45,100 --> 04:48:46,501 >> THANK YOU SO MUCH. 6818 04:48:46,501 --> 04:48:48,870 WHAT A GREAT EXAMPLE OF THE 6819 04:48:48,870 --> 04:48:49,938 CROSS-CENTER COLLABORATIONS. 6820 04:48:49,938 --> 04:48:51,540 I THINK NEXT I'LL TURN IT OVER 6821 04:48:51,540 --> 04:48:53,942 TO DR. LIU WHO IS GOING TO TALK 6822 04:48:53,942 --> 04:48:56,678 ABOUT THE CENTER FOR BIOLOGICS 6823 04:48:56,678 --> 04:49:07,155 EVALUATION AND RESEARCH AND 6824 04:49:11,760 --> 04:49:12,894 >> ALL RIGHT. 6825 04:49:12,894 --> 04:49:13,662 GOOD AFTERNOON. 6826 04:49:13,662 --> 04:49:15,597 FIRST I WOULD LIKE TO THANK THE 6827 04:49:15,597 --> 04:49:17,366 ORGANIZERS FOR THE INVITATION. 6828 04:49:17,366 --> 04:49:20,202 IT HAS BEEN A FANTASTIC MEETING 6829 04:49:20,202 --> 04:49:22,104 AND IT'S A PRETTY GREAT PLEASURE 6830 04:49:22,104 --> 04:49:23,605 TO BE HERE. 6831 04:49:23,605 --> 04:49:28,610 SO WE HAVE HEARD QUITE A BIT 6832 04:49:28,610 --> 04:49:31,046 ABOUT -- IN THE PAST THREE DAYS 6833 04:49:31,046 --> 04:49:33,248 AND IN FACT THE OFFICE OF 6834 04:49:33,248 --> 04:49:34,316 THERAPEUTIC PRODUCTS ACTUALLY 6835 04:49:34,316 --> 04:49:36,184 OVERSEES A LOT OF THESE 6836 04:49:36,184 --> 04:49:36,551 PRODUCTS. 6837 04:49:36,551 --> 04:49:38,587 SO FOR TODAY, I WOULD LIKE TO 6838 04:49:38,587 --> 04:49:41,657 JUST GIVE A VERY HIGH LEVEL 6839 04:49:41,657 --> 04:49:42,958 OVERVIEW OF OPPORTUNITIES TO 6840 04:49:42,958 --> 04:49:46,228 INTERACT WITH THE OFFICE OF 6841 04:49:46,228 --> 04:49:46,995 THERAPEUTIC PRODUCTS, AND I HOPE 6842 04:49:46,995 --> 04:49:49,197 THIS INFORMATION WILL BE HELPFUL 6843 04:49:49,197 --> 04:49:52,267 TO ALL THE GREAT WORK THAT YOU 6844 04:49:52,267 --> 04:49:54,102 ARE DOING. 6845 04:49:54,102 --> 04:49:55,971 SO THE OFFICE OF THERAPEUTIC 6846 04:49:55,971 --> 04:49:59,474 PRODUCTS OTP IS A SUPER OFFICE 6847 04:49:59,474 --> 04:50:02,010 THAT WAS ESTABLISHED BACK IN 6848 04:50:02,010 --> 04:50:02,477 2023. 6849 04:50:02,477 --> 04:50:06,748 THIS OFFICE OVERSEES A VARIETY 6850 04:50:06,748 --> 04:50:09,718 OF PRODUCTS, INCLUDING CELL 6851 04:50:09,718 --> 04:50:11,553 THERAPY, GENE THERAPY, 6852 04:50:11,553 --> 04:50:14,623 THERAPEUTIC VACCINES, 6853 04:50:14,623 --> 04:50:16,491 TRANSPLANTATION, HUMAN TISSUE 6854 04:50:16,491 --> 04:50:17,225 PRODUCTS, COMBINATION PRODUCTS 6855 04:50:17,225 --> 04:50:18,393 AND DEVICE, YOU NAME IT. 6856 04:50:18,393 --> 04:50:20,729 WE HAVE SIX OFFICES AND THREE OF 6857 04:50:20,729 --> 04:50:23,732 THE OFFICES ARE FOR 6858 04:50:23,732 --> 04:50:24,599 MANUFACTURING REVIEW, AND ONE 6859 04:50:24,599 --> 04:50:26,468 OFFICE IS FOR CLINICAL REVIEW 6860 04:50:26,468 --> 04:50:31,473 AND THEN ONE OFFICE IS 6861 04:50:31,473 --> 04:50:33,342 PHARMACOLOGY TOXICOLOGY REVIEW 6862 04:50:33,342 --> 04:50:35,977 AND ALSO OFFICE OF REVIEW 6863 04:50:35,977 --> 04:50:39,481 MANAGEMENT AND REGULATORY 6864 04:50:39,481 --> 04:50:39,715 REVIEW. 6865 04:50:39,715 --> 04:50:41,350 THERE ARE MANY OPPORTUNITIES TO 6866 04:50:41,350 --> 04:50:44,219 INTERACT WITH OTP DURING THE 6867 04:50:44,219 --> 04:50:45,587 PRODUCT DEVELOPMENT. 6868 04:50:45,587 --> 04:50:49,424 WE HIGHLY ENCOURAGE OUR SPONSORS 6869 04:50:49,424 --> 04:50:51,827 TO UTILIZE ALL THE MILESTONES, 6870 04:50:51,827 --> 04:50:58,967 FOR EXAMPLE THE PRE-IND AND ONE 6871 04:50:58,967 --> 04:51:00,969 AND TWO, IN ADDITION, EARLY IN 6872 04:51:00,969 --> 04:51:02,704 THE NONBINDING REGULATORY ADVICE 6873 04:51:02,704 --> 04:51:05,507 CAN BE OBTAINED FOR 6874 04:51:05,507 --> 04:51:06,742 MANUFACTURING, FOR ANIMAL 6875 04:51:06,742 --> 04:51:09,978 STUDIES, FOR CLINICAL 6876 04:51:09,978 --> 04:51:11,780 DEVELOPMENT THROUGH THE INDIRECT 6877 04:51:11,780 --> 04:51:14,182 MEETING WHICH STANDS FOR INITIAL 6878 04:51:14,182 --> 04:51:15,951 TARGETED ENGAGEMENT FOR 6879 04:51:15,951 --> 04:51:18,220 REGULATORY DEVICE ON C DE R 6880 04:51:18,220 --> 04:51:18,587 PRODUCTS. 6881 04:51:18,587 --> 04:51:20,722 WE ALSO HAVE MANY OTHER 6882 04:51:20,722 --> 04:51:22,324 OPPORTUNITIES AND FOR ENHANCED 6883 04:51:22,324 --> 04:51:24,926 COMMUNICATION WITH OTP FOR ALL 6884 04:51:24,926 --> 04:51:26,895 STAKEHOLDERS, AND THIS SLIDE 6885 04:51:26,895 --> 04:51:29,865 PROVIDES SOME EXAMPLES OF SUCH 6886 04:51:29,865 --> 04:51:30,432 OPPORTUNITIES. 6887 04:51:30,432 --> 04:51:32,033 THE PATIENT FOCUSED DRUG 6888 04:51:32,033 --> 04:51:33,702 DEVELOPMENT MEETINGS, PATIENT 6889 04:51:33,702 --> 04:51:35,670 LISTENING SESSIONS, AND 6890 04:51:35,670 --> 04:51:37,406 REGENERATIVE MEDICINE EDUCATION 6891 04:51:37,406 --> 04:51:40,175 WEBINARS ARE ALL PART OUR 6892 04:51:40,175 --> 04:51:43,011 COLLABORATIVE EFFORT TO CONNECT 6893 04:51:43,011 --> 04:51:44,980 WITH PATIENT COMMUNITIES AND TO 6894 04:51:44,980 --> 04:51:49,484 BETTER UNDERSTAND PATIENT 6895 04:51:49,484 --> 04:51:50,452 PERSPECTIVES, EXPERIENCE. 6896 04:51:50,452 --> 04:51:53,221 FOR RARE DISEASES, THE RDEA 6897 04:51:53,221 --> 04:51:55,490 PROGRAM IS DESIGNED TO PROVIDE A 6898 04:51:55,490 --> 04:51:58,160 PLATFORM FOR OUR SPONSORS TO 6899 04:51:58,160 --> 04:51:59,461 COLLABORATE WITH THE FDA THROUGH 6900 04:51:59,461 --> 04:52:06,668 THE DEVELOPMENT OF NOVEL 6901 04:52:06,668 --> 04:52:08,303 ENDPOINTS AND START WAS VERY 6902 04:52:08,303 --> 04:52:10,071 WELL RECEIVED AND CAN PROVIDE 6903 04:52:10,071 --> 04:52:13,909 ANOTHER PATHWAY FOR RARE DISEASE 6904 04:52:13,909 --> 04:52:15,310 DRUG THERAPEUTICS -- DRUG 6905 04:52:15,310 --> 04:52:16,845 DEVELOPERS TO ENGAGE WITH THE 6906 04:52:16,845 --> 04:52:20,682 FDA AND TO ACCELERATE DRUG 6907 04:52:20,682 --> 04:52:20,982 DEVELOPMENT. 6908 04:52:20,982 --> 04:52:23,852 FOR TECHNOLOGY FOCUSED PROGRAMS, 6909 04:52:23,852 --> 04:52:25,487 WE HAVE THE PLATFORM TECHNOLOGY 6910 04:52:25,487 --> 04:52:26,254 DESIGNATION. 6911 04:52:26,254 --> 04:52:30,192 THIS ONE IS DESIGNED FOR 6912 04:52:30,192 --> 04:52:31,393 TECHNOLOGIES THAT ARE WELL 6913 04:52:31,393 --> 04:52:33,228 UNDERSTOOD AND REPRODUCIBLE AND 6914 04:52:33,228 --> 04:52:35,564 WE HOPE TO LEVERAGE THE 6915 04:52:35,564 --> 04:52:37,199 NONCLINICAL DATA AND 6916 04:52:37,199 --> 04:52:39,501 MANUFACTURING DATA OF THESE 6917 04:52:39,501 --> 04:52:42,137 TECHNOLOGIES AND FOR 6918 04:52:42,137 --> 04:52:43,438 ACCELERATING PRODUCT DEVELOPMENT 6919 04:52:43,438 --> 04:52:45,140 FOR OTHER PRODUCTS. 6920 04:52:45,140 --> 04:52:48,143 ON THE OTHER HAND, THE CBER 6921 04:52:48,143 --> 04:52:51,346 ADVANCED TECHNOLOGY TEAM 6922 04:52:51,346 --> 04:52:52,881 MEETINGS FOCUS ON NOVEL 6923 04:52:52,881 --> 04:52:54,716 TECHNOLOGIES THAT HAVE THE 6924 04:52:54,716 --> 04:52:56,384 POTENTIAL TO HAVE SIGNIFICANT 6925 04:52:56,384 --> 04:52:59,354 IMPACT ON PRODUCT DEVELOPMENT. 6926 04:52:59,354 --> 04:53:02,290 THE ENHANCED COMMUNICATIONS ARE 6927 04:53:02,290 --> 04:53:03,925 ALSO OFFERED THROUGH OUR 6928 04:53:03,925 --> 04:53:06,328 EXPEDITED PROGRAMS, FOR EXAMPLE, 6929 04:53:06,328 --> 04:53:07,762 FAST TRACK, BREAK THROUGH 6930 04:53:07,762 --> 04:53:09,431 THERAPY AND RMAT. 6931 04:53:09,431 --> 04:53:10,732 I'M GOING TO TALK A LITTLE BIT 6932 04:53:10,732 --> 04:53:13,368 MORE ABOUT THE RMAT DESIGNATION 6933 04:53:13,368 --> 04:53:17,839 AS IT IS RATHER UNIQUE TO OTP 6934 04:53:17,839 --> 04:53:20,909 REGULATED PRODUCTS. 6935 04:53:20,909 --> 04:53:24,112 SO RMAT STANDS FOR REGENERATIVE 6936 04:53:24,112 --> 04:53:25,013 MEDICINE ADVANCED THERAPY. 6937 04:53:25,013 --> 04:53:29,484 THE PROGRAM WAS ESTABLISHEDS BY 6938 04:53:29,484 --> 04:53:31,186 THE 21ST CENTURY CURES ACT IN 6939 04:53:31,186 --> 04:53:34,155 2016 AND IS BASICALLY 6940 04:53:34,155 --> 04:53:38,326 REGENERATIVE MEDICINE ADVANCED 6941 04:53:38,326 --> 04:53:38,894 THERAPIES. 6942 04:53:38,894 --> 04:53:39,995 THE FOLLOWING PROVIDES A 6943 04:53:39,995 --> 04:53:41,763 DEFINITION OF REGENERATIVE 6944 04:53:41,763 --> 04:53:42,731 MEDICINE THERAPY. 6945 04:53:42,731 --> 04:53:46,568 LTS DEFINED BY THE FACT AS CELL 6946 04:53:46,568 --> 04:53:47,669 THERAPY, THERAPEUTIC TISSUE 6947 04:53:47,669 --> 04:53:48,803 ENGINEERING PRODUCTS, HUMAN CELL 6948 04:53:48,803 --> 04:53:51,172 AND TISSUE PRODUCTS, OR ANY 6949 04:53:51,172 --> 04:53:53,241 COMBINATION PRODUCT USING SUCH 6950 04:53:53,241 --> 04:53:55,010 THERAPIES OR PRODUCTS. 6951 04:53:55,010 --> 04:53:55,977 COMBINATION PRODUCT CAN BE 6952 04:53:55,977 --> 04:53:58,780 ELIGIBLE FOR RMAT DESIGNATION 6953 04:53:58,780 --> 04:54:01,249 WHEN THE BIOLOGICAL COMPONENT 6954 04:54:01,249 --> 04:54:02,851 PROVIDES THE GREATEST 6955 04:54:02,851 --> 04:54:04,986 CONTRIBUTION TO THE OVERALL 6956 04:54:04,986 --> 04:54:06,087 INTENDED EFFECTS OF THE 6957 04:54:06,087 --> 04:54:08,290 COMBINATION PRODUCT. 6958 04:54:08,290 --> 04:54:10,692 IN ADDITION, GENE THERAPIES, 6959 04:54:10,692 --> 04:54:12,327 INCLUDING GENETICALLY MODIFIED 6960 04:54:12,327 --> 04:54:14,429 CELLS, THAT LEAD TO A SUSTAINED 6961 04:54:14,429 --> 04:54:18,700 EFFECT ON CELLS OR TISSUES, SUCH 6962 04:54:18,700 --> 04:54:22,304 AS ANTI-VIRAL GENE THERAPY, 6963 04:54:22,304 --> 04:54:24,172 MEDIATED GENE THERAPY ARE ALSO 6964 04:54:24,172 --> 04:54:26,241 CONSIDERED AS REGENERATIVE 6965 04:54:26,241 --> 04:54:30,512 MEDICINE THERAPY. 6966 04:54:30,512 --> 04:54:32,814 FOR RMAT DESIGNATION AN 6967 04:54:32,814 --> 04:54:34,015 INVESTIGATIONAL DRUG MUST MEET 6968 04:54:34,015 --> 04:54:35,951 THE DEFINITION OF REGENERATIVE 6969 04:54:35,951 --> 04:54:37,819 MEDICINE THERAPY. 6970 04:54:37,819 --> 04:54:39,588 THE DRUG MUST BE INTENDED TO 6971 04:54:39,588 --> 04:54:41,690 TREAT, MODIFY, REVERSE OR CURE A 6972 04:54:41,690 --> 04:54:43,425 SERIOUS OR LIFE-THREATENING 6973 04:54:43,425 --> 04:54:46,661 DISEASE OR CONDITION, IN 6974 04:54:46,661 --> 04:54:48,763 ADDITION, PRELIMINARY CLINICAL 6975 04:54:48,763 --> 04:54:50,765 EVIDENCE NEEDS TO SUPPORT THAT 6976 04:54:50,765 --> 04:54:52,500 THE DRUG HAS THE POE TECIALG TO 6977 04:54:52,500 --> 04:54:54,569 ADDRESS UNMET -- POTENTIAL TO 6978 04:54:54,569 --> 04:54:56,438 ADDRESS UNMET NEEDS FOR SUCH 6979 04:54:56,438 --> 04:54:58,173 DISEASE OR CONDITION. 6980 04:54:58,173 --> 04:55:01,576 MUCH THE VANGDZ OF THE RMAT 6981 04:55:01,576 --> 04:55:02,544 DESIGNATION INCLUDE ALL OF THE 6982 04:55:02,544 --> 04:55:04,613 BENEFIT OF THE FAST TRACK AND 6983 04:55:04,613 --> 04:55:05,513 BREAKTHROUGH DESIGNATION 6984 04:55:05,513 --> 04:55:06,915 PROGRAMS, INCLUDING EARLY 6985 04:55:06,915 --> 04:55:08,783 INTERACTIONS WITH FDA TO DISCUSS 6986 04:55:08,783 --> 04:55:11,419 ANY POTENTIAL SURROGATE OR 6987 04:55:11,419 --> 04:55:12,821 INTERMEDIATE ENDPOINTS TO 6988 04:55:12,821 --> 04:55:16,024 SUPPORT ACCELERATED APPROVAL. 6989 04:55:16,024 --> 04:55:17,559 THE STATUTE ALSO ADDRESSES 6990 04:55:17,559 --> 04:55:19,427 POTENTIAL WAYS TO SUPPORT 6991 04:55:19,427 --> 04:55:22,364 ACCELERATED APPROVAL AND SATISFY 6992 04:55:22,364 --> 04:55:25,667 POST-APPROVAL REQUIREMENTS. 6993 04:55:25,667 --> 04:55:27,235 I DON'T HAVE TIME TO GO INTO ALL 6994 04:55:27,235 --> 04:55:29,137 THE DETAILS OF ALL THE WONDERFUL 6995 04:55:29,137 --> 04:55:31,439 PROGRAMS, BUT I DOMENT TO SHARE 6996 04:55:31,439 --> 04:55:32,974 THIS PIE CHART WITH YOU -- BUT I 6997 04:55:32,974 --> 04:55:34,309 DO WANT TO SHARE THIS PIE CHART 6998 04:55:34,309 --> 04:55:34,843 WITH YOU. 6999 04:55:34,843 --> 04:55:40,849 AS OF DECEMBER 2023, WE RECEIVED 7000 04:55:40,849 --> 04:55:42,283 270 RMAT DESIGNATION REQUESTS. 7001 04:55:42,283 --> 04:55:45,520 OF THESE, 99 WERE GRANTED. 7002 04:55:45,520 --> 04:55:48,390 AND AS SHOWN IN THIS PIE CHART, 7003 04:55:48,390 --> 04:55:52,761 NEUROLOGY HAS THE MOST RMAT 7004 04:55:52,761 --> 04:55:55,997 DESIGNATION REQUESTS. 7005 04:55:55,997 --> 04:55:59,467 I THINK THIS IS A GREAT 7006 04:55:59,467 --> 04:56:01,503 REPRESENTATION FOR THE INTEREST 7007 04:56:01,503 --> 04:56:03,038 FOR THE DEVELOPMENT OF 7008 04:56:03,038 --> 04:56:04,706 REGENERATIVE MEDICINE, PRECISION 7009 04:56:04,706 --> 04:56:05,907 MEDICINE FOR NEUROLOGICAL 7010 04:56:05,907 --> 04:56:09,511 DISORDERS INCLUDING ALZHEIMER'S 7011 04:56:09,511 --> 04:56:09,744 DISEASE. 7012 04:56:09,744 --> 04:56:12,414 WITH THAT, HERE IS OUR CONTACT 7013 04:56:12,414 --> 04:56:15,283 INFORMATION AND A LOT OF 7014 04:56:15,283 --> 04:56:16,584 WEBSITE, THE RESOURCES PROVIDED 7015 04:56:16,584 --> 04:56:16,785 THERE. 7016 04:56:16,785 --> 04:56:23,425 THANK YOU. 7017 04:56:23,425 --> 04:56:26,461 >> THANK YOU SO MUCH, DR. LIU. 7018 04:56:26,461 --> 04:56:28,430 I'M HAPPY TO TURN IT OVER TO MY 7019 04:56:28,430 --> 04:56:31,066 COLLEAGUE AND PARTNER 7020 04:56:31,066 --> 04:56:33,201 DR. MICHELLE CAMPBELL WHO WORKS 7021 04:56:33,201 --> 04:56:35,970 SO MUCH ACROSS NEURAL PROGRAMS, 7022 04:56:35,970 --> 04:56:37,439 PATIENT FOCUSED DEVELOPMENT. 7023 04:56:37,439 --> 04:56:38,306 >> THANK YOU. 7024 04:56:38,306 --> 04:56:40,809 I'LL SPEND THE NEXT COUPLE 7025 04:56:40,809 --> 04:56:41,509 MINUTES TALKING ABOUT HOW WE 7026 04:56:41,509 --> 04:56:44,846 WANT TO CAPTURE THE LIVED 7027 04:56:44,846 --> 04:56:46,848 EXPERIENCE. 7028 04:56:46,848 --> 04:56:48,917 I'M IN THE OFFICE OF 7029 04:56:48,917 --> 04:56:50,552 NEUROSCIENCE IN C DE R BUT THE 7030 04:56:50,552 --> 04:56:52,654 PROGRAMS I'LL BE TALKING ABOUT 7031 04:56:52,654 --> 04:56:54,923 ARE ACROSS ALL THREE MEDICAL 7032 04:56:54,923 --> 04:56:57,525 PRODUCT CENTERS INCLUDING CBER 7033 04:56:57,525 --> 04:56:58,460 AS WELL. 7034 04:56:58,460 --> 04:57:00,228 PATIENT FOCUSED DRUG DISWOMENT A 7035 04:57:00,228 --> 04:57:03,498 SYSTEM ABILITY APPROACH TO HELP 7036 04:57:03,498 --> 04:57:04,666 ENSURE THAT THE PATIENT'S 7037 04:57:04,666 --> 04:57:05,467 EXPERIENCES, PERSPECTIVES AND 7038 04:57:05,467 --> 04:57:07,001 NEEDS ARE CAPTURED AND 7039 04:57:07,001 --> 04:57:07,769 MEANINGFULLY INCORPORATED INTO 7040 04:57:07,769 --> 04:57:10,739 DRUG DEVELOPMENT AND EVALUATION. 7041 04:57:10,739 --> 04:57:12,340 SO FIRST AND FOREMOST IN OUR 7042 04:57:12,340 --> 04:57:14,476 EVERY DAY AS DR. BURACCHIO SAID 7043 04:57:14,476 --> 04:57:16,211 WHAT, WE THINK ABOUT, SO FOR US, 7044 04:57:16,211 --> 04:57:17,979 WE ALSO THINK ABOUT AS WE WANT 7045 04:57:17,979 --> 04:57:19,948 TO HAVE TREATMENTS THAT ARE 7046 04:57:19,948 --> 04:57:20,615 CLINICALLY MEANINGFUL TO 7047 04:57:20,615 --> 04:57:22,050 PATIENTS THAT DEMONSTRATES THAT 7048 04:57:22,050 --> 04:57:23,585 THEY IMPROVE HOW THEY FEEL, 7049 04:57:23,585 --> 04:57:27,856 FUNCTION OR SURVIVE. 7050 04:57:27,856 --> 04:57:30,024 PATIENT FOCUSED DRUG DEVELOPMENT 7051 04:57:30,024 --> 04:57:31,659 IS REALLY CAUTERIZED AND PULLED 7052 04:57:31,659 --> 04:57:33,328 OUT AND SPECIFICALLY LISTED. 7053 04:57:33,328 --> 04:57:36,364 BACK IN 2012 THIS REALLY CAME 7054 04:57:36,364 --> 04:57:38,333 ABOUT, AND SO IT'S BEEN A 7055 04:57:38,333 --> 04:57:40,769 PLEASURE TO WORK IN THIS SPACE 7056 04:57:40,769 --> 04:57:42,337 SINCE ITS INFANCY OF REALLY HOW 7057 04:57:42,337 --> 04:57:45,573 DO WE APPLY THIS TO DRUG 7058 04:57:45,573 --> 04:57:47,342 DEVELOPMENT, BECAUSE IT HAS 7059 04:57:47,342 --> 04:57:48,743 GROWN AMAZINGLY IN THE LAST 7060 04:57:48,743 --> 04:57:50,278 DECADE WITH HOW DO WE 7061 04:57:50,278 --> 04:57:53,214 INCORPORATE PATIENT FOCUSED DRUG 7062 04:57:53,214 --> 04:57:54,649 DEVELOPMENT THROUGHOUT THE DRUG 7063 04:57:54,649 --> 04:57:55,650 DEVELOPMENT LIFE CYCLE. 7064 04:57:55,650 --> 04:57:57,485 ILT IMPORTANT TO NOTE THAT FOR 7065 04:57:57,485 --> 04:57:59,254 PATIENT FOCUSED DRUG DEVELOPMENT 7066 04:57:59,254 --> 04:58:01,322 FDA IS JUST ONE STAKEHOLDER. 7067 04:58:01,322 --> 04:58:02,390 INDUSTRY, ACADEMIA EXPSK 7068 04:58:02,390 --> 04:58:03,658 PATIENTS AND THEIR FAMILIES ARE 7069 04:58:03,658 --> 04:58:05,026 OTHER KEY STAKEHOLDERS THAT NEED 7070 04:58:05,026 --> 04:58:06,761 TO BE THOUGHT ABOUT WHEN WE'RE 7071 04:58:06,761 --> 04:58:08,463 CONSIDERING HOW TO DEVELOP DRUGS 7072 04:58:08,463 --> 04:58:10,965 AND THERAPIES FOR ALZHEIMER'S, 7073 04:58:10,965 --> 04:58:12,600 AND I THINK YOUR PANEL YESTERDAY 7074 04:58:12,600 --> 04:58:15,436 MORNING REALLY HIGHLIGHTED THAT 7075 04:58:15,436 --> 04:58:17,305 ABOUT HOW PEOPLE TALKED ABOUT 7076 04:58:17,305 --> 04:58:18,606 THEIR EXPERIENCE WS THEIR LOVED 7077 04:58:18,606 --> 04:58:19,908 ONES AND WHAT WERE THOSE 7078 04:58:19,908 --> 04:58:21,709 OPPORTUNITIES FOR THEM TO LEARN 7079 04:58:21,709 --> 04:58:24,512 MORE ABOUT IF THEY HAVE A RISK 7080 04:58:24,512 --> 04:58:25,914 FOR DEVELOPMENT, AND I THINK 7081 04:58:25,914 --> 04:58:28,383 THAT WAS A REALLY GREAT EXAMPLE 7082 04:58:28,383 --> 04:58:29,784 AND THEY WERE PROVIDING SOME 7083 04:58:29,784 --> 04:58:32,187 REALLY GREAT EXAMPLES OF HOW TO 7084 04:58:32,187 --> 04:58:34,622 INCORPORATE THEIR THOUGHTS INTO 7085 04:58:34,622 --> 04:58:36,124 EITHER CLINICAL PRACTICE, 7086 04:58:36,124 --> 04:58:40,295 CLINICAL RESEARCH AND CLINICAL 7087 04:58:40,295 --> 04:58:42,297 TRIALS. 7088 04:58:42,297 --> 04:58:42,664 SPECIFIC. 7089 04:58:42,664 --> 04:58:44,966 LY FOR FDA, SPECIFIC THINGS WE 7090 04:58:44,966 --> 04:58:46,434 HAVE LED IN OUR UNDERTAKING 7091 04:58:46,434 --> 04:58:48,736 FIRST AND FOREMOST WAS OUR FDA 7092 04:58:48,736 --> 04:58:51,472 LED PATIENT FOCUSED DRUG 7093 04:58:51,472 --> 04:58:52,774 DEVELOPMENT MEETINGS THAT CAME 7094 04:58:52,774 --> 04:58:54,642 OUT OF FIVE, WE WERE MANDATED TO 7095 04:58:54,642 --> 04:58:56,277 HAVE SO MANY MEETINGS AND WITH 7096 04:58:56,277 --> 04:58:57,812 SO MANY DISEASES AND DISORDERS, 7097 04:58:57,812 --> 04:58:59,013 WE HAD TO FIGURE OUT WHICH ONES 7098 04:58:59,013 --> 04:59:00,148 TO START WITH. 7099 04:59:00,148 --> 04:59:02,417 WE DID DO SUCCESSFULLY EXCEED 7100 04:59:02,417 --> 04:59:06,454 OUR MANDATES AND WE LEARNED FROM 7101 04:59:06,454 --> 04:59:07,655 DISEASES THAT HAVE MAYBE A 7102 04:59:07,655 --> 04:59:10,124 LARGER POPULATION OF FOLKS, AND 7103 04:59:10,124 --> 04:59:11,292 RARE DISEASE AS WELL. 7104 04:59:11,292 --> 04:59:12,460 WHAT WE LEARNED, WHICH I THINK 7105 04:59:12,460 --> 04:59:14,629 FOR A LOT OF US IN THIS AUDIENCE 7106 04:59:14,629 --> 04:59:18,633 WE KNOW, BUT IT REALLY, REALLY 7107 04:59:18,633 --> 04:59:20,268 RANG TRUE AND IS THE HALLMARK OF 7108 04:59:20,268 --> 04:59:22,804 HOW WE PRACTICE PFDD IS PATIENTS 7109 04:59:22,804 --> 04:59:24,105 ARE THE EXPERTS OF THEIR 7110 04:59:24,105 --> 04:59:25,206 CONDITIONS, AND WE SHOULD REALLY 7111 04:59:25,206 --> 04:59:27,108 BE TALKING TO THEM BECAUSE WE 7112 04:59:27,108 --> 04:59:29,043 KNOW THAT IN DRUG DEVELOPMENT, 7113 04:59:29,043 --> 04:59:30,345 SOMETIMES WHAT IS BEING CAPTURED 7114 04:59:30,345 --> 04:59:31,880 IS ACTUALLY NOT WHAT'S 7115 04:59:31,880 --> 04:59:32,747 MEANINGFUL TO PATIENTS. 7116 04:59:32,747 --> 04:59:36,084 SO WE REALLY NEED TO MAKE SURE 7117 04:59:36,084 --> 04:59:38,019 WE'RE TAKING INTO THOSE 7118 04:59:38,019 --> 04:59:39,120 EXPERIENCES INTO OUR DRUG 7119 04:59:39,120 --> 04:59:39,454 DEVELOPMENT. 7120 04:59:39,454 --> 04:59:40,755 IT'S ALSO IMPORTANT TO NOTE THAT 7121 04:59:40,755 --> 04:59:42,657 WHEN WE'RE APPLYING PATIENT 7122 04:59:42,657 --> 04:59:44,192 FOCUSED DRUG DEVELOPMENTS INTO 7123 04:59:44,192 --> 04:59:45,260 CLINICAL TRIAL DESIGN, WE ALSO 7124 04:59:45,260 --> 04:59:47,662 HAVE TO BALANCE ALL THE OTHER 7125 04:59:47,662 --> 04:59:48,897 THINGS WE'VE BEEN TALKING ABOUT, 7126 04:59:48,897 --> 04:59:50,298 WHAT DO WE THINK THE DRUG GOING 7127 04:59:50,298 --> 04:59:53,034 TO DO, DHUNG WE THINK WE'LL SEE 7128 04:59:53,034 --> 04:59:54,802 AN EFFECT, WILL WE BE ABLE TO 7129 04:59:54,802 --> 04:59:56,104 CHANGE THIS CONCEPT THAT IS 7130 04:59:56,104 --> 04:59:57,839 REALLY IMPORTANT TO FAMILIES AND 7131 04:59:57,839 --> 05:00:01,042 TO PATIENT FROM THAT TREATMENT. 7132 05:00:01,042 --> 05:00:03,311 WE HAVE SUCCESSFULLY 7133 05:00:03,311 --> 05:00:05,947 TRANSITIONED FROM FDA LED PFFD 7134 05:00:05,947 --> 05:00:08,549 MEETINGS WHICH WE STILL WILL 7135 05:00:08,549 --> 05:00:10,652 HOST AS NEEDED TO A VERY 7136 05:00:10,652 --> 05:00:12,186 SUCCESSFUL EXTERNALLY LED 7137 05:00:12,186 --> 05:00:14,956 PATIENT FOCUSED DRUG DEVELOPMENT 7138 05:00:14,956 --> 05:00:16,591 PROGRAM WHERE PATIENT GROUPS 7139 05:00:16,591 --> 05:00:19,761 WILL SUBMIT LETTERS OF INTENT TO 7140 05:00:19,761 --> 05:00:21,562 CDER, WANTING TO HOST MEETINGS, 7141 05:00:21,562 --> 05:00:23,498 AND ONCE YOU ENGAGE WITH THE 7142 05:00:23,498 --> 05:00:24,832 PATIENT FOCUSED DRUG DEVELOPMENT 7143 05:00:24,832 --> 05:00:26,668 STAFF ON HOW TO DO THAT, SO THEY 7144 05:00:26,668 --> 05:00:28,102 DO HAVE SOMEONE TO WORK WITH, 7145 05:00:28,102 --> 05:00:31,706 THEY WORK WITH US, AND REVIEW 7146 05:00:31,706 --> 05:00:33,675 DIVISIONS ABOUT HOSTING THESE 7147 05:00:33,675 --> 05:00:35,543 MEETINGS. 7148 05:00:35,543 --> 05:00:37,078 AGAIN, WHILE SOME OF THESE ARE 7149 05:00:37,078 --> 05:00:38,913 HOSTED OUT OF C DE R, ALL THREE 7150 05:00:38,913 --> 05:00:39,714 OF THE MEDICAL PRODUCT CENTERS 7151 05:00:39,714 --> 05:00:40,915 ARE FULLY INVOLVED AND 7152 05:00:40,915 --> 05:00:43,318 PARTICIPATE IN THESE MEETING AS 7153 05:00:43,318 --> 05:00:43,551 WELL. 7154 05:00:43,551 --> 05:00:45,153 SO THAT IS A GREAT VENUE FOR 7155 05:00:45,153 --> 05:00:45,486 THAT. 7156 05:00:45,486 --> 05:00:47,155 SO WE HAVE SOME UPCOMING 7157 05:00:47,155 --> 05:00:47,422 MEETINGS. 7158 05:00:47,422 --> 05:00:49,424 WE HAVE A MEETING IN I WANT TO 7159 05:00:49,424 --> 05:00:50,992 SAY TWO WEEKS, MAYBE THREE AT 7160 05:00:50,992 --> 05:00:52,927 THIS POINT, IF I CAN REMEMBER 7161 05:00:52,927 --> 05:00:56,698 CORRECTLY MY CALENDAR, FOR 7162 05:00:56,698 --> 05:00:59,000 DEMENTIA WITH LEWY BODY ON 7163 05:00:59,000 --> 05:01:01,035 OCTOBER 15 AND THEN THERE'S ONE 7164 05:01:01,035 --> 05:01:02,503 ON HUNTINGTON'S IN NOVEMBER, 7165 05:01:02,503 --> 05:01:06,641 WE'VE ALSO HAD SOME OTHER 7166 05:01:06,641 --> 05:01:07,608 EXTERNAL PATIENT MEANS AND SOME 7167 05:01:07,608 --> 05:01:11,112 OF THE OTHER ADRD RELATED 7168 05:01:11,112 --> 05:01:11,379 DEMENTIAS. 7169 05:01:11,379 --> 05:01:14,082 WE HAVE A PATIENT FOCUSED DRUG 7170 05:01:14,082 --> 05:01:15,183 DEVELOPMENT METHODOLOGICAL 7171 05:01:15,183 --> 05:01:16,684 GUIDANCE SERIES, AND THIS IS, I 7172 05:01:16,684 --> 05:01:18,252 WILL SAY, AS SOMEONE WHO HELPED 7173 05:01:18,252 --> 05:01:19,988 CONTRIBUTE TO IT, IT WAS A LABOR 7174 05:01:19,988 --> 05:01:21,189 OF LOVE, AND YOU'LL PROBABLY 7175 05:01:21,189 --> 05:01:22,724 NEVER SEE A GUIDANCE SERIES EVER 7176 05:01:22,724 --> 05:01:23,591 LIKE THAT AGAIN. 7177 05:01:23,591 --> 05:01:24,926 SO I'M GOING TO HOLD OFF, I 7178 05:01:24,926 --> 05:01:26,361 THINK MY NEXT SLIDE IS ACTUAL ON 7179 05:01:26,361 --> 05:01:27,795 THAT SERIES, AND I'LL TALK A 7180 05:01:27,795 --> 05:01:29,163 LITTLE BIT MORE ABOUT THAT. 7181 05:01:29,163 --> 05:01:31,599 WHILE WE ARE NOT A FUNDING 7182 05:01:31,599 --> 05:01:34,335 AGENCY LIKE OUR COLLEAGUES AT 7183 05:01:34,335 --> 05:01:36,604 NIA AND NIH, WE DID FUND A PILOT 7184 05:01:36,604 --> 05:01:37,839 PROGRAM IN TRYING TO ADVANCE 7185 05:01:37,839 --> 05:01:41,342 DEVELOPMENT OF CLINICAL OUTCOME 7186 05:01:41,342 --> 05:01:42,443 ASSESSMENTS IN SPECIFIC DISEASE 7187 05:01:42,443 --> 05:01:45,279 AREAS OR CONCEPT AREAS. 7188 05:01:45,279 --> 05:01:48,282 SO REALLY WE ARE FULLY TRENCHED 7189 05:01:48,282 --> 05:01:50,284 IN PUSHING FORWARD PATIENT 7190 05:01:50,284 --> 05:01:55,223 FOCUSED DRUG DEVELOPMENT IN MANY 7191 05:01:55,223 --> 05:01:55,656 WAYS. 7192 05:01:55,656 --> 05:01:57,458 THE OTHER PIECE IS PATIENT 7193 05:01:57,458 --> 05:01:58,059 EXPERIENCE DATA. 7194 05:01:58,059 --> 05:02:00,161 THIS ALSO CAME OUT OF 21ST 7195 05:02:00,161 --> 05:02:02,363 CERTAIN TRI CURES AND HAS A 7196 05:02:02,363 --> 05:02:04,565 REALLY BIG DEFINITION -- REALLY 7197 05:02:04,565 --> 05:02:06,300 BROAD DEFINITION OF WHAT IS IT. 7198 05:02:06,300 --> 05:02:08,269 PATIENTS HAVE A PLETHORA OF 7199 05:02:08,269 --> 05:02:09,237 INFORMATION THAT THEY WANT TO 7200 05:02:09,237 --> 05:02:10,438 SHARE, AND THEY WANT US TO SEE 7201 05:02:10,438 --> 05:02:14,475 IT AND TO BE INFORMED BY IT. 7202 05:02:14,475 --> 05:02:15,943 REALLY PATIENT EXPERIENCE DATA, 7203 05:02:15,943 --> 05:02:17,678 THIS IS NOT THE FINAL LIST. 7204 05:02:17,678 --> 05:02:19,213 IT IS JUST A SNIPPET OF WHAT 7205 05:02:19,213 --> 05:02:20,848 THAT CAN LOOK LIKE. 7206 05:02:20,848 --> 05:02:22,817 SO IT CAN BE SOMETHING SUCH AS 7207 05:02:22,817 --> 05:02:24,152 PATIENT LISTENING SESSIONS OR 7208 05:02:24,152 --> 05:02:26,821 PATIENT FOCUSED DRUG DEVELOPMENT 7209 05:02:26,821 --> 05:02:27,422 SESSIONS, PATIENT EXPERIENCE 7210 05:02:27,422 --> 05:02:29,090 DATA IS THE CLINICAL OUTCOME 7211 05:02:29,090 --> 05:02:31,359 ASSESS THAMENTS ARE USED IN 7212 05:02:31,359 --> 05:02:32,827 CLINICAL TRIALS TO SUPPORT OUR 7213 05:02:32,827 --> 05:02:33,995 CLINICAL TRIAL ENDPOINTS, IT 7214 05:02:33,995 --> 05:02:35,263 COULD BE PATIENT PREFERENCE 7215 05:02:35,263 --> 05:02:36,230 STUDIES PARTICULARLY ON SAFETY 7216 05:02:36,230 --> 05:02:37,865 THAT A LOT OF WORK PARTICULARLY 7217 05:02:37,865 --> 05:02:40,735 IN GENE THERAPIES WITH MY CBER 7218 05:02:40,735 --> 05:02:41,936 COLLEAGUES LOOKING AT SAFETY 7219 05:02:41,936 --> 05:02:44,238 PROFILES AND WHAT IS SOMEONE'S 7220 05:02:44,238 --> 05:02:46,974 RISK TOLERANCE FOR THESE 7221 05:02:46,974 --> 05:02:47,341 NEUROTHERAPIES. 7222 05:02:47,341 --> 05:02:49,710 THEY CAN INCLUDE QUALITATIVE 7223 05:02:49,710 --> 05:02:52,246 INFORMATION ON BENEFIT/RISK AND 7224 05:02:52,246 --> 05:02:53,414 CLINICAL MEANINGFULNESS, WHICH 7225 05:02:53,414 --> 05:02:55,550 IS REALLY A CONVERSATION WE HAVE 7226 05:02:55,550 --> 05:02:56,851 EVERY DAY ABOUT WHAT WE'RE 7227 05:02:56,851 --> 05:02:57,952 REVIEWING DATA, IT'S IMPORTANT 7228 05:02:57,952 --> 05:02:59,921 TO NOTE THAT WHEN WE TALK ABOUT 7229 05:02:59,921 --> 05:03:01,589 CLINICAL MEANINGFULNESS, WE ARE 7230 05:03:01,589 --> 05:03:04,058 REALLY INTERESTED IN MEANINGFUL 7231 05:03:04,058 --> 05:03:04,525 WITHIN PATIENT CHANGE. 7232 05:03:04,525 --> 05:03:06,494 SO WHAT IS HAPPENING AT THE 7233 05:03:06,494 --> 05:03:08,029 PATIENT LEVEL, AND IS IT 7234 05:03:08,029 --> 05:03:09,263 MEANINGFUL TO THEM, BECAUSE WE 7235 05:03:09,263 --> 05:03:10,998 KNOW THAT SOMETIMES THE MINIMAL 7236 05:03:10,998 --> 05:03:12,867 AMOUNT OF CHANGE IS OFTEN MAY 7237 05:03:12,867 --> 05:03:14,769 NOT BE MEANINGFUL TO THEM. 7238 05:03:14,769 --> 05:03:16,504 SO THERE ARE MULTIPLE WAYS THAT 7239 05:03:16,504 --> 05:03:18,673 WE CAN ACTUALLY EXPLORE THIS, 7240 05:03:18,673 --> 05:03:19,774 AND PATIENT EXPERIENCE DATA 7241 05:03:19,774 --> 05:03:20,808 THROUGH QUALITATIVE METHODS IS 7242 05:03:20,808 --> 05:03:22,944 ONE OF THOSE WAYS. 7243 05:03:22,944 --> 05:03:25,046 SO THE METHODOLOGICAL GUIDANCES 7244 05:03:25,046 --> 05:03:26,647 SERIES, YOU WILL NEVER SEE AN 7245 05:03:26,647 --> 05:03:28,082 FDA GUIDANCE EVER LOOK LIKE THIS 7246 05:03:28,082 --> 05:03:28,316 AGAIN. 7247 05:03:28,316 --> 05:03:29,617 I'M JUST GOING TO TELL YOU THAT 7248 05:03:29,617 --> 05:03:31,252 RIGHT NOW. 7249 05:03:31,252 --> 05:03:33,554 IT IS A FOUR PART GUIDANCE 7250 05:03:33,554 --> 05:03:36,190 SERIES, AND IT IS AN EXTREMELY 7251 05:03:36,190 --> 05:03:38,926 LENGTHY GUIDANCE SERIES. 7252 05:03:38,926 --> 05:03:41,562 EACH GUIDANCE IS ABOUT 40 PAGES. 7253 05:03:41,562 --> 05:03:42,997 SO NOT TO SCARE YOU ANY MORE OFF 7254 05:03:42,997 --> 05:03:44,966 OF THAT, WHY IS THIS SO 7255 05:03:44,966 --> 05:03:47,368 REVOLUTIONARY THOUGH FOR PATIENT 7256 05:03:47,368 --> 05:03:48,236 FOCUSED DRUG DEVELOPMENT? 7257 05:03:48,236 --> 05:03:51,539 BECAUSE WE BASICALLY WROTE AN 7258 05:03:51,539 --> 05:03:52,306 ENCYCLOPEDIA/COOKBOOK FOR 7259 05:03:52,306 --> 05:03:54,342 EVERYONE, SO WHAT WE DID AND WE 7260 05:03:54,342 --> 05:03:57,545 WERE UNDER OUR 281ST CENTURY 7261 05:03:57,545 --> 05:03:58,746 CURES WE WERE MANDATED TO PUT 7262 05:03:58,746 --> 05:04:00,515 THIS TOGETHER BUT IT WAS ALREADY 7263 05:04:00,515 --> 05:04:01,349 SOMETHING WE WERE ALREADY 7264 05:04:01,349 --> 05:04:03,584 THINKING ABOUT DOING OURSELVES 7265 05:04:03,584 --> 05:04:06,521 WITHOUT HAVING HAD IT ADDED INTO 7266 05:04:06,521 --> 05:04:08,156 PADUFFA EFER, WE WERE REALLY 7267 05:04:08,156 --> 05:04:09,557 THINKING ABOUT HOW DO WE 7268 05:04:09,557 --> 05:04:10,558 APPROACH THIS. 7269 05:04:10,558 --> 05:04:12,326 FIRST TWO GUIDANCE IS ABOUT HOW 7270 05:04:12,326 --> 05:04:14,162 DO WE COLLECT COMPREHENSIVE AND 7271 05:04:14,162 --> 05:04:15,363 REPRESENTATIVE INPUTS, 7272 05:04:15,363 --> 05:04:16,264 YESTERDAY'S PANEL WAS A GREAT 7273 05:04:16,264 --> 05:04:18,432 WAY TO SHOW THE DIVERSITY IN THE 7274 05:04:18,432 --> 05:04:21,202 SPACE AND WHY WE NEED TO DO THIS 7275 05:04:21,202 --> 05:04:21,836 QUALITATIVE WORK. 7276 05:04:21,836 --> 05:04:24,472 FROM GUIDANCE ONE YOU GO INTO 7277 05:04:24,472 --> 05:04:26,007 GUIDANCE TWO WHICH IS HOW DO WE 7278 05:04:26,007 --> 05:04:28,609 START APPLYING SCIENTIFIC RIGOR 7279 05:04:28,609 --> 05:04:30,178 TO CAPTURING QUALITATIVE 7280 05:04:30,178 --> 05:04:30,511 INFORMATION. 7281 05:04:30,511 --> 05:04:32,046 FIRST TWO GUIDE ANS ONE AND TWO 7282 05:04:32,046 --> 05:04:33,447 WERE WRITTEN, IF YOU LOOK AT 7283 05:04:33,447 --> 05:04:34,882 THEM, FOR PATIENT GROUPS IN MIND 7284 05:04:34,882 --> 05:04:36,083 BECAUSE WE KNOW THAT THEY'RE 7285 05:04:36,083 --> 05:04:37,618 OFTEN STARTING A LOT OF THIS 7286 05:04:37,618 --> 05:04:40,021 DATA COLLECTION EFFORTS. 7287 05:04:40,021 --> 05:04:41,789 GUIDANCES THREE AND FOUR SHIFT A 7288 05:04:41,789 --> 05:04:42,657 LITTLE BIT AND THEY'RE 7289 05:04:42,657 --> 05:04:43,891 DEFINITELY MORE TECHNICAL, I 7290 05:04:43,891 --> 05:04:45,593 WILL SAY, AND THESE WERE 7291 05:04:45,593 --> 05:04:47,795 DEFINITELY FOR INDUSTRY, BECAUSE 7292 05:04:47,795 --> 05:04:51,432 WHAT GUIDANCE THREE DOES, EACH 7293 05:04:51,432 --> 05:04:52,600 GUIDANCE BUILDS UPON THEMSELVES. 7294 05:04:52,600 --> 05:04:54,268 SO GUIDANCE THREE IS SAYING, 7295 05:04:54,268 --> 05:04:55,937 WELL, YOU'VE TAKEN WHEUF DONE IN 7296 05:04:55,937 --> 05:04:57,905 ONE AND TWO -- TAKEN WHAT YOU'VE 7297 05:04:57,905 --> 05:04:59,640 DONE IN ONE AND TWO AND 7298 05:04:59,640 --> 05:05:00,708 COLLECTED ALL THIS INFORMATION, 7299 05:05:00,708 --> 05:05:03,144 BUT NOW HOW DO WE SELECT A: CAL 7300 05:05:03,144 --> 05:05:04,579 OUTCOME ASSESSMENT, DO WE NEED 7301 05:05:04,579 --> 05:05:05,947 TO DEVELOP ONE OR MODIFY ONE AND 7302 05:05:05,947 --> 05:05:07,081 WHAT IS THE EVIDENTIARY 7303 05:05:07,081 --> 05:05:08,316 STANDARDS HA WE NEED FOR ALL 7304 05:05:08,316 --> 05:05:11,586 FOUR TYPES OF CLINICAL OUTCOME 7305 05:05:11,586 --> 05:05:12,253 ASSESSMENTS WHERE WE WANT TO USE 7306 05:05:12,253 --> 05:05:13,888 THEM TO SUPPORT OUR TRIAL 7307 05:05:13,888 --> 05:05:15,056 ENDPOINTS, AND THEN GUIDANCE 7308 05:05:15,056 --> 05:05:16,390 FOUR REALLY TALKS ABOUT HOW DO 7309 05:05:16,390 --> 05:05:18,226 WE GO FROM THE ENDPOINTS OR FROM 7310 05:05:18,226 --> 05:05:20,361 THE OUTCOME ASSESSMENT INTO IT 7311 05:05:20,361 --> 05:05:22,530 SUPPORTING THE CLINICAL TRIAL 7312 05:05:22,530 --> 05:05:22,797 ENDPOINT. 7313 05:05:22,797 --> 05:05:24,932 I WILL TELL YOU RIGHT NOW THEY 7314 05:05:24,932 --> 05:05:26,567 ARE A HEAVY READ. 7315 05:05:26,567 --> 05:05:28,202 I COMPLETELY ADMIT TO THAT. 7316 05:05:28,202 --> 05:05:29,737 BUT DON'T BE AFRAID OF THEM. 7317 05:05:29,737 --> 05:05:31,305 THERE ARE FOLKS OUT THERE WHO 7318 05:05:31,305 --> 05:05:32,473 COMPLETELY UNDERSTAND THEM. 7319 05:05:32,473 --> 05:05:33,608 WE UNDERSTAND THEM. 7320 05:05:33,608 --> 05:05:35,276 SO IF YOU COME AND GET ADVICE TO 7321 05:05:35,276 --> 05:05:36,577 US EARLY WE CAN HELP PROVIDE 7322 05:05:36,577 --> 05:05:38,079 SOME UNDERSTANDING OF WHAT'S IN 7323 05:05:38,079 --> 05:05:38,279 THERE. 7324 05:05:38,279 --> 05:05:39,947 AND I CAN'T GO TOO FAR WITHOUT 7325 05:05:39,947 --> 05:05:41,682 QUICKLY MENTIONING DIGITAL 7326 05:05:41,682 --> 05:05:42,917 HEALTH TECHNOLOGY, WHICH IS 7327 05:05:42,917 --> 05:05:45,086 ALONG WITH AI AND MACHINE 7328 05:05:45,086 --> 05:05:46,954 LEARNING ARE SOME OF THE 7329 05:05:46,954 --> 05:05:48,656 NEUROOPPORTUNITIES FOR US TO 7330 05:05:48,656 --> 05:05:50,124 COLLECT INFORMATION, AND I KNOW 7331 05:05:50,124 --> 05:05:52,560 WE HAD THE MORNING SESSION 7332 05:05:52,560 --> 05:05:54,095 HIGHLIGHTED SOME ASPECTS WITH 7333 05:05:54,095 --> 05:05:54,829 DIGITAL HEALTH TECHNOLOGY. 7334 05:05:54,829 --> 05:05:57,598 SO THIS IS OUR DEFINITION OF 7335 05:05:57,598 --> 05:05:58,799 DIGITAL HEALTH TECHNOLOGIES FOR 7336 05:05:58,799 --> 05:06:00,034 ALL THREE MEDICAL PRODUCT 7337 05:06:00,034 --> 05:06:01,702 CENTERS AND YOU CAN FIND THIS IN 7338 05:06:01,702 --> 05:06:04,572 THE FDA NIH BEST GLOSSARY. 7339 05:06:04,572 --> 05:06:06,674 BUT OUR DEFINITION IS AN 7340 05:06:06,674 --> 05:06:08,109 EXTREMELY BROAD DEFINITION AS 7341 05:06:08,109 --> 05:06:10,177 IT'S A SYSTEM THAT USES 7342 05:06:10,177 --> 05:06:12,480 COMPUTING PLATFORMS, 7343 05:06:12,480 --> 05:06:14,248 CONNECTIVITY, SOFTWARE AND 7344 05:06:14,248 --> 05:06:16,384 SENSORS FOR HEALTHCARE USES, AND 7345 05:06:16,384 --> 05:06:17,418 YOU CAN SEE ON THE RIGHT-HAND 7346 05:06:17,418 --> 05:06:18,386 SIDE WHAT SOME OF THOSE 7347 05:06:18,386 --> 05:06:19,053 POTENTIAL USES COULD BE. 7348 05:06:19,053 --> 05:06:22,356 SO IT IS AN EXTREMELY BROAD 7349 05:06:22,356 --> 05:06:22,590 THING. 7350 05:06:22,590 --> 05:06:24,258 BUT WHAT DO I WANT YOU TO KNOW? 7351 05:06:24,258 --> 05:06:25,660 FIRST AND FOREMOST, WE HAVE A 7352 05:06:25,660 --> 05:06:26,427 GUIDANCE OUT. 7353 05:06:26,427 --> 05:06:27,728 WE'VE MENTIONED A COUPLE 7354 05:06:27,728 --> 05:06:29,130 GUIDANCES TO EVERYONE TODAY, 7355 05:06:29,130 --> 05:06:30,598 PLEASE KNOW THAT THESE GUIDE ANS 7356 05:06:30,598 --> 05:06:33,901 SHOULD NEVER BE READ AS A SINGLE 7357 05:06:33,901 --> 05:06:34,168 GUIDANCE. 7358 05:06:34,168 --> 05:06:35,936 THERE IS PROBABLY A GUIDANCE OF 7359 05:06:35,936 --> 05:06:37,138 A NUMBER OF 207 IKS THAT 7360 05:06:37,138 --> 05:06:38,472 COMPLEMENT THE OTHER GUIDANCE 7361 05:06:38,472 --> 05:06:40,107 THAT YOU'RE READING. 7362 05:06:40,107 --> 05:06:44,812 SO OUR FINAL GUIDANCE CAME OUT 7363 05:06:44,812 --> 05:06:46,914 IN DECEMBER, AND IT REALLY 7364 05:06:46,914 --> 05:06:49,750 FOCUSES ON WHAT IS NEEDED FOR 7365 05:06:49,750 --> 05:06:52,153 COLLECTING REMOTE DATA IN 7366 05:06:52,153 --> 05:06:53,521 CLINICAL INVESTIGATIONS. 7367 05:06:53,521 --> 05:06:58,626 IT REALLY TALKS ABOUT THE HAVE 7368 05:06:58,626 --> 05:06:59,794 ADDITION AND VERIFICATION WORK 7369 05:06:59,794 --> 05:07:01,128 THAT IS NEEDED FROM THE DEVICE 7370 05:07:01,128 --> 05:07:02,997 THAT THE DIGITAL HEALTH 7371 05:07:02,997 --> 05:07:03,998 TECHNOLOGY STANDPOINTS. 7372 05:07:03,998 --> 05:07:07,068 IT DOES NOT TALK ABOUT HOW YOU 7373 05:07:07,068 --> 05:07:08,703 TAKE THE DATA THAT'S BEEN 7374 05:07:08,703 --> 05:07:10,438 COLLECTED AND HOW IS THAT DATA 7375 05:07:10,438 --> 05:07:12,973 THEN EITHER GOING TO BE USED TO 7376 05:07:12,973 --> 05:07:15,142 SUPPORT A DIGITALLY DERIVED 7377 05:07:15,142 --> 05:07:18,045 BIOMARKER OR A DIGITALLY DERIVED 7378 05:07:18,045 --> 05:07:18,312 ENDPOINT. 7379 05:07:18,312 --> 05:07:19,480 AND WE KNOW THAT THERE'S A BIG 7380 05:07:19,480 --> 05:07:22,416 FOCUS IN WANTING TO USE DHT'S TO 7381 05:07:22,416 --> 05:07:24,852 SUPPORT DIGITALLY DERIVED 7382 05:07:24,852 --> 05:07:26,153 ENDPOINTS AND WE WOULD SAY THAT 7383 05:07:26,153 --> 05:07:28,589 ONCE THE CONTEXT OF USE HAS BEEN 7384 05:07:28,589 --> 05:07:29,890 DETERMINED, WE WILL THEN NEED TO 7385 05:07:29,890 --> 05:07:31,058 THROW IN WHAT WE KNOW ABOUT THE 7386 05:07:31,058 --> 05:07:32,493 EVIDENCE WE NEED FOR ENDPOINTS 7387 05:07:32,493 --> 05:07:35,029 IN THERE AS WELL. 7388 05:07:35,029 --> 05:07:38,599 SO MY FINAL REMARKS, HOW DO WE 7389 05:07:38,599 --> 05:07:39,934 REALLY IMPLEMENT PATIENT FOCUSED 7390 05:07:39,934 --> 05:07:41,469 DRUG DEVELOPMENT IN ALZHEIMER'S. 7391 05:07:41,469 --> 05:07:43,637 FIRST AND FOREMOST AS 7392 05:07:43,637 --> 05:07:44,538 DR. BURACCHIO SAID, WE NEED TO 7393 05:07:44,538 --> 05:07:45,740 INCORPORATE AND LEVERAGE WHAT IS 7394 05:07:45,740 --> 05:07:47,375 KNOWN WITH THE BIOLOGY OF THE 7395 05:07:47,375 --> 05:07:49,110 DISEASE, AND I WOULD SAY EVEN MY 7396 05:07:49,110 --> 05:07:50,644 CLINICAL PHARMACOLOGY 7397 05:07:50,644 --> 05:07:51,379 COLLEAGUES, THE INFORMATION 7398 05:07:51,379 --> 05:07:52,613 THEY'RE DOING, THIS IS GOING TO 7399 05:07:52,613 --> 05:07:54,181 BE EXTREMELY IMPORTANT IN HOW 7400 05:07:54,181 --> 05:07:56,016 WE'LL APPROACH PATIENT FOCUSED 7401 05:07:56,016 --> 05:07:56,650 DRUG DEVELOPMENT. 7402 05:07:56,650 --> 05:07:59,320 WE NEED TO EMPLOY QUALITATIVE 7403 05:07:59,320 --> 05:08:01,622 METHOD OLINGSZ TO COLLECT THE 7404 05:08:01,622 --> 05:08:03,023 LIVED -- METH ODOLOGIES TO 7405 05:08:03,023 --> 05:08:03,991 COLLECT LIVED EXPERIENCE 7406 05:08:03,991 --> 05:08:04,792 INFORMATION THROUGHOUT THE 7407 05:08:04,792 --> 05:08:06,961 SPECTRUM AND STAGES OF AD AND TO 7408 05:08:06,961 --> 05:08:09,263 WANT HEAR FROM BOTH PERSONS WITH 7409 05:08:09,263 --> 05:08:10,998 AD PARTICULARLY IF IT'S BEEN 7410 05:08:10,998 --> 05:08:11,766 EARLIER IDENTIFIED AND THOSE 7411 05:08:11,766 --> 05:08:13,968 THAT MAY BE AT A HIGHER RISK OF 7412 05:08:13,968 --> 05:08:15,069 DEVELOPING, WE HEARD FROM THOSE 7413 05:08:15,069 --> 05:08:16,270 FOLKS YESTERDAY AND THAT'S A 7414 05:08:16,270 --> 05:08:17,471 GREAT OPPORTUNITY, AS WELL AS 7415 05:08:17,471 --> 05:08:19,240 FAMILIES AND CAREGIVERS AND THE 7416 05:08:19,240 --> 05:08:20,975 FULL SPECTRUM IS CRITICALLY 7417 05:08:20,975 --> 05:08:21,942 IMPORTANT TO KIND OF KNOW 7418 05:08:21,942 --> 05:08:23,811 BECAUSE WHAT MAY BE IMPORTANT AT 7419 05:08:23,811 --> 05:08:26,213 ONE POINT MOST LIKELY WILL SHIFT 7420 05:08:26,213 --> 05:08:28,549 OVER TIME FROM WHAT WE'VE HEARD 7421 05:08:28,549 --> 05:08:31,051 FROM OUR EXPERIENCES TALKING TO 7422 05:08:31,051 --> 05:08:31,318 FAMILIES. 7423 05:08:31,318 --> 05:08:33,154 AND FINALLY, WE WANT TO CONSIDER 7424 05:08:33,154 --> 05:08:34,088 IMPLEMENTING ALL DIFFERENT TYPES 7425 05:08:34,088 --> 05:08:36,424 OF CLINICAL OUTCOME ASSESSMENTS 7426 05:08:36,424 --> 05:08:38,592 P WHEN WE CAN INTO OUR CLINICAL 7427 05:08:38,592 --> 05:08:38,926 TRIALS. 7428 05:08:38,926 --> 05:08:40,461 THIS ALSO CAN INCLUDE INCLUDING 7429 05:08:40,461 --> 05:08:42,763 USE OF DIGITAL HEALTH 7430 05:08:42,763 --> 05:08:45,933 TECHNOLOGIES, SO THIS IS WHEN WE 7431 05:08:45,933 --> 05:08:47,034 ALWAYS SAY COME EARLY AND OFTEN 7432 05:08:47,034 --> 05:08:48,669 AND TALK TO US SO WE CAN GIVE 7433 05:08:48,669 --> 05:08:50,971 THE BEST ADVICE AND APPROACHES 7434 05:08:50,971 --> 05:08:53,941 ON HOW TO LEVERAGE AL TYPES HAD 7435 05:08:53,941 --> 05:08:54,809 OF ASSESSMENTS. 7436 05:08:54,809 --> 05:08:56,444 WITH THAT, I TURN IT BACK TO 7437 05:08:56,444 --> 05:09:00,147 YOU. 7438 05:09:00,147 --> 05:09:00,281 S. 7439 05:09:00,281 --> 05:09:04,618 >> SO I THINK WE HAVE FIVE 7440 05:09:04,618 --> 05:09:05,519 MINUTES, IF ANYBODY IN THE 7441 05:09:05,519 --> 05:09:06,787 AUDIENCE HAS ANY QUESTIONS, THEY 7442 05:09:06,787 --> 05:09:08,722 CAN COME UP TO THE MICROPHONE 7443 05:09:08,722 --> 05:09:12,026 AND ASK QUESTIONS OF ANY OF THE 7444 05:09:12,026 --> 05:09:12,460 PANELISTS. 7445 05:09:12,460 --> 05:09:22,937 WE MIGHT HAVE A FEW ONLINE. 7446 05:10:02,243 --> 05:10:03,110 >> THANK YOU. 7447 05:10:03,110 --> 05:10:05,212 SO WE HAVE AN ONLINE QUESTION 7448 05:10:05,212 --> 05:10:06,947 ABOUT FDA GUIDELINES. 7449 05:10:06,947 --> 05:10:09,383 SO SOME FDA GUIDELINES AVAILABLE 7450 05:10:09,383 --> 05:10:10,684 ONLINE ARE DRAFTS. 7451 05:10:10,684 --> 05:10:12,419 MY UNDERSTANDING IS THAT THEY'RE 7452 05:10:12,419 --> 05:10:14,622 NOT THE FINAL OR OFFICIAL 7453 05:10:14,622 --> 05:10:16,257 VERSIONS, SO HOW SHOULD THE 7454 05:10:16,257 --> 05:10:17,892 AUDIENCE LOOK AT THEM 7455 05:10:17,892 --> 05:10:25,165 CRITICALLY? 7456 05:10:25,165 --> 05:10:28,536 >> SO THE DRAFTS, WE I SHALL 7457 05:10:28,536 --> 05:10:29,970 INITIALLY PUT OUT GUIDE ANS AS 7458 05:10:29,970 --> 05:10:30,204 DRAFTS. 7459 05:10:30,204 --> 05:10:32,473 THEY EMPLOY OUT FOR A PUBLIC 7460 05:10:32,473 --> 05:10:33,807 COMMENT PERIOD. 7461 05:10:33,807 --> 05:10:36,410 WE THEN WILL -- THEY GO OUT FOR 7462 05:10:36,410 --> 05:10:37,545 A PUBLIC COMMENT PERIOD. 7463 05:10:37,545 --> 05:10:40,047 WE THEN WILL TAKE THE PUBLIC 7464 05:10:40,047 --> 05:10:41,348 COMMENT AND DISCERN IF WE NEED 7465 05:10:41,348 --> 05:10:43,183 TO MAKE REVISIONS TO THE 7466 05:10:43,183 --> 05:10:44,852 GUIDANCE BASED ON THE PUBLIC 7467 05:10:44,852 --> 05:10:46,687 COMMENTS THAT WE RECEIVE. 7468 05:10:46,687 --> 05:10:48,656 SOMETIMES WE WILL MAKE REVISIONS 7469 05:10:48,656 --> 05:10:50,291 PRETTY QUICKLY DEPENDING ON THE 7470 05:10:50,291 --> 05:10:52,059 TYPE OF COMMENTS WE GOT. 7471 05:10:52,059 --> 05:10:54,929 OTHER TIMES, WE WILL TAKE THOSE 7472 05:10:54,929 --> 05:10:55,829 COMMENTS UNDER CONSIDERATION, 7473 05:10:55,829 --> 05:10:57,965 BUT WE MAY NOT FEEL THAT ANY 7474 05:10:57,965 --> 05:11:00,935 IMMEDIATE CHANGES ARE NEEDED. 7475 05:11:00,935 --> 05:11:02,670 WE TYPICALLY DO REVISIT 7476 05:11:02,670 --> 05:11:03,804 GUIDANCES EVERY FEW YEARS, I 7477 05:11:03,804 --> 05:11:05,506 CAN'T REMEMBER, I THINK THERE'S 7478 05:11:05,506 --> 05:11:06,941 A RECOMMENDATION OF, YOU KNOW, 7479 05:11:06,941 --> 05:11:08,475 EVERY FIVE YEARS OR SO WE SHOULD 7480 05:11:08,475 --> 05:11:09,910 REVISIT THEM AND SEE IF THEY 7481 05:11:09,910 --> 05:11:11,779 NEEDED TO BE UP2K5EU9D AND WE 7482 05:11:11,779 --> 05:11:13,647 WILL UP-- UPDATED AND WE WILL 7483 05:11:13,647 --> 05:11:14,848 UPDATE THEM AS NEEDED. 7484 05:11:14,848 --> 05:11:17,084 IF IT IS AN AREA OR FIELD WHERE 7485 05:11:17,084 --> 05:11:20,220 THERE'S STILL A LOT OF EVOLVING 7486 05:11:20,220 --> 05:11:21,422 THINKING AND CHANGES IN 7487 05:11:21,422 --> 05:11:23,190 SCIENTIFIC KNOWLEDGE, GUIDE ANS 7488 05:11:23,190 --> 05:11:25,593 CAN REMAIN IN DRAFT FOR A FAIR 7489 05:11:25,593 --> 05:11:27,761 AMOUNT OF TIME, BECAUSE WE KNOW 7490 05:11:27,761 --> 05:11:29,296 THAT THEY'RE GOING TO NEED TO BE 7491 05:11:29,296 --> 05:11:31,699 CONTINUED TO BE UPDATED, AND WE 7492 05:11:31,699 --> 05:11:33,567 MAY IN SOME CASES WE MAY NEVER 7493 05:11:33,567 --> 05:11:35,869 BE ABLE TO ISSUE A FINAL 7494 05:11:35,869 --> 05:11:36,136 GUIDANCE. 7495 05:11:36,136 --> 05:11:38,572 I'LL SAY THAT IN PARTICULAR WITH 7496 05:11:38,572 --> 05:11:40,374 THE ALWAYS ALZHEIMER'S DISEASE 7497 05:11:40,374 --> 05:11:41,775 GUIDANCE, WE'VE HAD NOW THREE 7498 05:11:41,775 --> 05:11:42,009 DRAFTS. 7499 05:11:42,009 --> 05:11:44,211 IT WILL BE UPDATED AGAIN HAD THE 7500 05:11:44,211 --> 05:11:46,847 FUTURE, I THINK AS WE CONTINUE 7501 05:11:46,847 --> 05:11:48,916 AS OUR KNOWLEDGE CHANGED, YOU 7502 05:11:48,916 --> 05:11:50,451 KNOW, AND WE MOVE ALONG. 7503 05:11:50,451 --> 05:11:52,853 BUT THAT IS ONE THAT I FIND IS 7504 05:11:52,853 --> 05:11:53,821 PARTICULARLY, WILL BE 7505 05:11:53,821 --> 05:11:55,556 PARTICULARLY CHALLENGING TO MAKE 7506 05:11:55,556 --> 05:11:57,558 IN A FINAL FORM BECAUSE THE 7507 05:11:57,558 --> 05:11:59,526 FIELD IS SO RAPIDLY EVOLVING 7508 05:11:59,526 --> 05:12:01,161 RIGHT NOW. 7509 05:12:01,161 --> 05:12:03,697 SO, YOU KNOW, I THINK THE DRAFT 7510 05:12:03,697 --> 05:12:04,832 GUIDANCES THAT ARE OUT THERE, 7511 05:12:04,832 --> 05:12:07,534 EVEN THOUGH THEY SAY DRAFT, DO 7512 05:12:07,534 --> 05:12:09,970 REPRESENT OUR CURRENT THINKING, 7513 05:12:09,970 --> 05:12:11,939 AND JUST BECAUSE IT DOESN'T SAY 7514 05:12:11,939 --> 05:12:14,308 FINAL DOESN'T MEAN THAT IT'S, 7515 05:12:14,308 --> 05:12:16,644 YOU KNOW, NOT REPRESENTATIVE OUR 7516 05:12:16,644 --> 05:12:17,044 THINKING. 7517 05:12:17,044 --> 05:12:20,114 IT'S JUST THAT IT MAY BE UPDATED 7518 05:12:20,114 --> 05:12:27,821 AGAIN IN THE FUTURE. 7519 05:12:27,821 --> 05:12:29,356 >> MAYO CLINIC. 7520 05:12:29,356 --> 05:12:29,957 THANK YOU VERY MUCH. 7521 05:12:29,957 --> 05:12:32,593 THANK YOU, NIA, FOR BRINGING OUR 7522 05:12:32,593 --> 05:12:35,562 COLLEAGUES AT FDA TO US. 7523 05:12:35,562 --> 05:12:38,399 SO WE'VE HEARD AT THESE MEETINGS 7524 05:12:38,399 --> 05:12:40,701 THAT THERE ARE HUNDREDS OF 7525 05:12:40,701 --> 05:12:43,871 POTENTIAL THERAPEUTIC TARGETS, 7526 05:12:43,871 --> 05:12:46,507 AND INVESTIGATORS ARE WORKING ON 7527 05:12:46,507 --> 05:12:51,111 HUNDREDS OF THEM, MAYBE TENS OF 7528 05:12:51,111 --> 05:12:53,213 THEM OR TOWARDS A HUNDRED OF 7529 05:12:53,213 --> 05:12:57,451 THEM ARE IN LATER STAGES IN OUR 7530 05:12:57,451 --> 05:13:00,087 LABS, AND I ALSO APPRECIATED THE 7531 05:13:00,087 --> 05:13:02,389 PIPELINE OF ENCOURAGING 7532 05:13:02,389 --> 05:13:03,524 INVESTIGATORS TO MEET WITH FDA 7533 05:13:03,524 --> 05:13:06,660 IN THE PRE-PREIND STAGES, BUT 7534 05:13:06,660 --> 05:13:08,929 CONSIDERING THAT, EVEN FROM FDA 7535 05:13:08,929 --> 05:13:11,265 THERE ARE 600 THERAPEUTIC 7536 05:13:11,265 --> 05:13:12,566 TARGETS, WHEN IS A REALLY GOOD 7537 05:13:12,566 --> 05:13:14,668 TIME TO GET TOGETHER WITH OUR 7538 05:13:14,668 --> 05:13:16,503 COLLEAGUES AT THE FDA TO DISCUSS 7539 05:13:16,503 --> 05:13:22,976 THE NEXT STEPS? 7540 05:13:22,976 --> 05:13:24,912 >> SO IN THE EARLIEST STAGES 7541 05:13:24,912 --> 05:13:26,547 WHEN YOU'RE STILL IN DISCOVERY, 7542 05:13:26,547 --> 05:13:28,782 WE WEREN'T ABLE TO GIVE TOO MUCH 7543 05:13:28,782 --> 05:13:31,618 SPECIFIC FEEDBACK ON A GIVEN 7544 05:13:31,618 --> 05:13:32,619 DRUG DEVELOPMENT PROGRAM AT THE 7545 05:13:32,619 --> 05:13:33,420 DISCOVERY STAGE. 7546 05:13:33,420 --> 05:13:34,688 THOSE SORTS OF STAGES ARE BETTER 7547 05:13:34,688 --> 05:13:37,291 FOR BROADER SCIENTIFIC MEETINGS, 7548 05:13:37,291 --> 05:13:39,293 YOU KNOW, SUCH AS MEETINGS 7549 05:13:39,293 --> 05:13:41,929 ORGANIZED BY NIA OR OTHER GROUPS 7550 05:13:41,929 --> 05:13:43,330 WHERE THE SORT OF STATE OF THE 7551 05:13:43,330 --> 05:13:45,833 SCIENCE IS DISCUSSED AND WE CAN 7552 05:13:45,833 --> 05:13:47,601 GIVE MORE BROADER FEEDBACK. 7553 05:13:47,601 --> 05:13:51,572 IT'S USUALLY WHEN A PRODUCT IS 7554 05:13:51,572 --> 05:13:55,242 READY TO MOVE INTO ITS FIRST 7555 05:13:55,242 --> 05:13:57,111 HUMAN STUDIES THAT WE START 7556 05:13:57,111 --> 05:13:58,679 BECOMING ENGAGED. 7557 05:13:58,679 --> 05:14:02,216 IF THERE ARE PARTICULAR ISSUES 7558 05:14:02,216 --> 05:14:03,650 WITH THE INTERACT MEETINGS, WE 7559 05:14:03,650 --> 05:14:05,419 ALSO DO HAVE THE INTERACT 7560 05:14:05,419 --> 05:14:07,287 MEETINGS, THEY STARTED IN CBER 7561 05:14:07,287 --> 05:14:09,690 BUT WE DO HAVE THEM IN CDER AS 7562 05:14:09,690 --> 05:14:11,458 WELL NOW, WHERE IF THERE'S 7563 05:14:11,458 --> 05:14:13,527 REALLY UNIQUE ASPECTS OF 7564 05:14:13,527 --> 05:14:15,062 DEVELOPMENT PERHAPS, YOU KNOW, 7565 05:14:15,062 --> 05:14:17,364 UNIQUE CHALLENGES THAT ARE NOT 7566 05:14:17,364 --> 05:14:18,565 COMMON AND ARE NOT ALREADY 7567 05:14:18,565 --> 05:14:19,867 ADDRESSED BY SOME OF THE 7568 05:14:19,867 --> 05:14:22,603 GUIDANCES THAT COME OUT, THOSE 7569 05:14:22,603 --> 05:14:24,505 ARE WHAT THOSE MEETINGS ARE 7570 05:14:24,505 --> 05:14:26,106 INTENDED FOR FOR REALLY UNIQUE 7571 05:14:26,106 --> 05:14:27,207 SITUATIONS, BUT EVEN THEN, 7572 05:14:27,207 --> 05:14:29,843 THAT'S USUALLY AT A STAGE WHERE 7573 05:14:29,843 --> 05:14:33,347 A DRUG OR A COUPLE OF DRUGS THAT 7574 05:14:33,347 --> 05:14:34,782 MEET A SPECIFIC TARGET ARE BEING 7575 05:14:34,782 --> 05:14:36,750 CONSIDERED FOR FURTHER 7576 05:14:36,750 --> 05:14:37,050 DEVELOPMENT. 7577 05:14:37,050 --> 05:14:39,253 SO THAT'S, WE USUALLY GET 7578 05:14:39,253 --> 05:14:40,788 INVOLVED A LITTLE AFTER THE 7579 05:14:40,788 --> 05:14:42,422 DISCOVERY PHASE, BUT WHEN WE'RE 7580 05:14:42,422 --> 05:14:43,957 STILL AT THE DISCOVERY PHASE, 7581 05:14:43,957 --> 05:14:45,392 YOU KNOW, THERE IS STILL 7582 05:14:45,392 --> 05:14:46,160 OPPORTUNITIES FOR ENGAGEMENT, 7583 05:14:46,160 --> 05:14:47,528 BUT THAT'S USUALLY GOING TO BE 7584 05:14:47,528 --> 05:14:50,330 AT A MORE GENERAL FORUM. 7585 05:14:50,330 --> 05:14:55,335 >> I JUST WONDERED, FOR INTERACT 7586 05:14:55,335 --> 05:14:57,237 MEETINGS, OFTENTIMES WE ADVISE 7587 05:14:57,237 --> 05:14:58,939 OUR SPONSORS TO COME TO US WHEN 7588 05:14:58,939 --> 05:15:01,141 THEY FINISH THEIR FIRST APPROVAL 7589 05:15:01,141 --> 05:15:04,111 CONCEPT STUDY. 7590 05:15:04,111 --> 05:15:06,046 HAVING STARTED ENABLING ANIMAL 7591 05:15:06,046 --> 05:15:07,581 STUDIES, SO THAT TYPICALLY IS A 7592 05:15:07,581 --> 05:15:11,418 GOOD TIME TO COME TALK TO US FOR 7593 05:15:11,418 --> 05:15:12,686 YOUR INTERACT MEETING. 7594 05:15:12,686 --> 05:15:13,887 REALLY THERE'S NO BAD TIME TO 7595 05:15:13,887 --> 05:15:14,922 COME TALK TO US. 7596 05:15:14,922 --> 05:15:16,557 DOESN'T MATTER WHERE IN THE 7597 05:15:16,557 --> 05:15:17,891 CLINICAL DEVELOPMENT STAGE YOU 7598 05:15:17,891 --> 05:15:19,726 ARE, AND JUST COME AND TALK TO 7599 05:15:19,726 --> 05:15:26,967 US, WE'LL FIGURE OUT A WAY. 7600 05:15:26,967 --> 05:15:29,236 >> -- FOR DR. BURACCHIO OR 7601 05:15:29,236 --> 05:15:31,104 ANYONE WHO CHOOSES TO FIELD IT. 7602 05:15:31,104 --> 05:15:32,673 I'M WONDERING HOW YOU WOULD 7603 05:15:32,673 --> 05:15:33,740 ENCOURAGE US TO BE THINKING 7604 05:15:33,740 --> 05:15:35,943 ABOUT THE INVOLVEMENT OF WHAT 7605 05:15:35,943 --> 05:15:39,213 BIOMARKER PANELS, AS THE 7606 05:15:39,213 --> 05:15:40,981 TECHNOLOGIES EVOLVE AND AS THE 7607 05:15:40,981 --> 05:15:42,816 COMPLEXITY OF POTENTIAL 7608 05:15:42,816 --> 05:15:45,319 THERAPIES EVOLVE, IN A PRECISION 7609 05:15:45,319 --> 05:15:46,353 MEDICINE CONTEXT BECAUSE THAT'S 7610 05:15:46,353 --> 05:15:56,864 THE THEME OF THE SUMMIT HERE. 7611 05:15:57,965 --> 05:15:59,399 >> I'LL START AND OTHERS CAN 7612 05:15:59,399 --> 05:16:01,268 JOIN ME. 7613 05:16:01,268 --> 05:16:03,437 P I THINK THAT'S A VERY GOOD 7614 05:16:03,437 --> 05:16:06,173 QUESTION WITH RESPECT TO HOW 7615 05:16:06,173 --> 05:16:08,141 SCIENCE WILL EVOLVE AND HOW 7616 05:16:08,141 --> 05:16:13,814 TECHNOLOGIES WILL ENABLE US. 7617 05:16:13,814 --> 05:16:14,815 HISTORICALLY WE HAVE BEEN TRYING 7618 05:16:14,815 --> 05:16:16,984 TO IDENTIFY THAT CRITICAL 7619 05:16:16,984 --> 05:16:18,652 BIOMARKER, THAT ONE KEY 7620 05:16:18,652 --> 05:16:20,187 BIOMARKER, AND WE DO REALIZE 7621 05:16:20,187 --> 05:16:24,591 THAT DISEASES ARE VERY 7622 05:16:24,591 --> 05:16:25,792 HETEROGENEOUS, THERE IS NO -- I 7623 05:16:25,792 --> 05:16:27,294 SHOULD NOT SAY THERE IS NO. 7624 05:16:27,294 --> 05:16:28,328 RARELY THERE IS INSTANCES THERE 7625 05:16:28,328 --> 05:16:30,497 IS ONLY ONE CHOKE POINT IF 7626 05:16:30,497 --> 05:16:32,566 EXPIEFD ADDRESSED THAT WOULD -- 7627 05:16:32,566 --> 05:16:33,667 IDENTIFIED AND ADDRESSED THAT 7628 05:16:33,667 --> 05:16:35,068 WOULD HELP TREAT A DISEASE KIND 7629 05:16:35,068 --> 05:16:36,370 OF SITUATION. 7630 05:16:36,370 --> 05:16:37,905 SO OBVIOUSLY APPEARS THE SCIENCE 7631 05:16:37,905 --> 05:16:39,673 EVOLVES AND TECHNOLOGIES COME 7632 05:16:39,673 --> 05:16:41,842 UP, MAYBE THERE WILL BE A SHIFT 7633 05:16:41,842 --> 05:16:43,610 TOWARDS PANELS OF BIOMARKERS 7634 05:16:43,610 --> 05:16:47,347 WHICH ARE GOING TO HAVE A -- AS 7635 05:16:47,347 --> 05:16:50,083 OPPOSED TO A SINGLE STAND ALONE 7636 05:16:50,083 --> 05:16:51,251 BIOMARKER BY ITSELF MAY NOT HAVE 7637 05:16:51,251 --> 05:16:53,353 THE ABILITY TO INFORM US, AND I 7638 05:16:53,353 --> 05:16:54,888 THINK WE'LL HAVE TO START 7639 05:16:54,888 --> 05:16:57,724 GETTING COMFORTABLE WITH THE 7640 05:16:57,724 --> 05:16:58,926 VARIOUS QUANTITATIVE AREAS TO BE 7641 05:16:58,926 --> 05:17:00,394 ABLE TO ANALYZE SUCH 7642 05:17:00,394 --> 05:17:00,694 INFORMATION. 7643 05:17:00,694 --> 05:17:02,195 WE KNOW HOW TO CREATE A SINGLE 7644 05:17:02,195 --> 05:17:02,462 RESPONSE. 7645 05:17:02,462 --> 05:17:04,531 WE KNOW HOW TO LOOK AT COMPOSITE 7646 05:17:04,531 --> 05:17:05,866 OF ENDPOINTS, FOR EXAMPLE. 7647 05:17:05,866 --> 05:17:08,235 SO THERE ARE SOME LEARNINGS 7648 05:17:08,235 --> 05:17:09,870 THERE AND PROBABLY THERE ARE 7649 05:17:09,870 --> 05:17:10,971 METHODOLOGIES WHICH WE WILL HAVE 7650 05:17:10,971 --> 05:17:12,406 TO START GETTING COMFORTABLE AT 7651 05:17:12,406 --> 05:17:16,109 SOME POINT OR TIME AS TO HOW TO 7652 05:17:16,109 --> 05:17:17,644 BEST INTEGRATE THE INFORMATION 7653 05:17:17,644 --> 05:17:20,280 ACROSS THE PANEL OF BIOMARKERS, 7654 05:17:20,280 --> 05:17:22,916 FIGURE OUT WHAT THEY MEAN, AND 7655 05:17:22,916 --> 05:17:25,152 CORRELATE THEM TO THE CLINICAL 7656 05:17:25,152 --> 05:17:25,419 OUTCOMES. 7657 05:17:25,419 --> 05:17:27,054 SO I THINK THIS WILL BE 7658 05:17:27,054 --> 05:17:28,689 SOMETHING THAT WE LOOK FORWARD 7659 05:17:28,689 --> 05:17:30,490 TO AND WILL BE SOMETHING THAT IT 7660 05:17:30,490 --> 05:17:36,330 WILL EVOLVE OVER A PERIOD OF 7661 05:17:36,330 --> 05:17:41,601 TIME. 7662 05:17:41,601 --> 05:17:42,336 OTHERS? 7663 05:17:42,336 --> 05:17:44,338 >> WE ALREADY ARE USING 7664 05:17:44,338 --> 05:17:46,640 BIOMARKERS WITHIN OUR CLINICAL 7665 05:17:46,640 --> 05:17:49,843 TRIALS AS FAR AS I MENTIONED FOR 7666 05:17:49,843 --> 05:17:51,578 ENRICHMENT, FOR ENROLLMENT 7667 05:17:51,578 --> 05:17:52,779 CRITERIA, FOR ENRICHMENT, AND IF 7668 05:17:52,779 --> 05:17:55,382 IT'S BEING USED IN DEVELOPMENT, 7669 05:17:55,382 --> 05:17:57,284 YOU KNOW, THERE'S ALWAYS 7670 05:17:57,284 --> 05:17:58,452 EXPLORATORY ENDPOINTS, IF IT'S 7671 05:17:58,452 --> 05:18:00,320 GOING TO BE USED TO SORT OF 7672 05:18:00,320 --> 05:18:01,321 TRACK CHANGES DURING THE COURSE 7673 05:18:01,321 --> 05:18:03,590 OF A CLINICAL TRIAL, WE 7674 05:18:03,590 --> 05:18:04,825 GENERALLY RECOMMEND THAT THOSE 7675 05:18:04,825 --> 05:18:08,762 BE INCLUDED AS EXPLORATORY 7676 05:18:08,762 --> 05:18:09,963 OUTCOME MEASURES IN THE TRIALS 7677 05:18:09,963 --> 05:18:11,498 HELP GENERATE THE DATA THAT WE 7678 05:18:11,498 --> 05:18:14,134 NEED TO THEN FURTHER SUPPORT 7679 05:18:14,134 --> 05:18:17,738 THEIR USE AS EITHER HIGHER IN 7680 05:18:17,738 --> 05:18:19,606 THE HIERARCHY OR EVEN AS A 7681 05:18:19,606 --> 05:18:21,108 SURROGATE ENDPOINT EVENTUALLY. 7682 05:18:21,108 --> 05:18:31,351 >> THANK YOU. 7683 05:18:35,555 --> 05:18:37,324 >> SAYS BEING AROUND DATA 7684 05:18:37,324 --> 05:18:38,392 SHARING THAT I THINK EVERYBODY 7685 05:18:38,392 --> 05:18:40,727 MAY NOT SRN OUR PREDICTIVE 7686 05:18:40,727 --> 05:18:42,596 SAFETY TESTING CONSORTIUM WAS 7687 05:18:42,596 --> 05:18:43,697 ABLE TO ACHIEVE A LETTER OF 7688 05:18:43,697 --> 05:18:45,198 SUPPORT IN SIX MONTHS, THEY HAVE 7689 05:18:45,198 --> 05:18:47,834 A MICRORNA PANEL TO PROJECT 7690 05:18:47,834 --> 05:18:50,470 PANCREATIC DRUG INDUCED TOXICITY 7691 05:18:50,470 --> 05:18:51,838 IN NONCLINICAL SPECIES. 7692 05:18:51,838 --> 05:18:54,007 THE REASON WHY IT TOOK SO FAST, 7693 05:18:54,007 --> 05:18:56,410 SIX MONTHS, IS SEVEN INDUSTRY 7694 05:18:56,410 --> 05:18:57,844 SPONSORS CONTRIBUTED DATA TO 7695 05:18:57,844 --> 05:18:58,378 SUPPORT THAT SUCCESS. 7696 05:18:58,378 --> 05:19:01,114 SO LTS A COMPOSITE, IT'S 7697 05:19:01,114 --> 05:19:02,416 MICRORNAS WHICH IS PRETTY 7698 05:19:02,416 --> 05:19:03,517 EXCITING AND I THINK IT SENDS 7699 05:19:03,517 --> 05:19:04,718 THE MESSAGE THAT WE'RE ALL 7700 05:19:04,718 --> 05:19:12,192 SAYING HERE ABOUT DATA SHARING. 7701 05:19:12,192 --> 05:19:13,493 >> I THINK WE'RE OUT OF TIME SO 7702 05:19:13,493 --> 05:19:15,562 WE'LL PASS IT TO THE NEXT PANEL, 7703 05:19:15,562 --> 05:19:16,229 LAST PANEL. 7704 05:19:16,229 --> 05:19:26,773 SO THANKS MY FELLOW COLLEAGUES. 7705 05:19:42,622 --> 05:19:45,358 >> GOOD AFTERNOON. 7706 05:19:45,358 --> 05:19:47,227 AS WE'RE TRYING TO CONCLUDE THE 7707 05:19:47,227 --> 05:19:50,964 SUMMIT FEST IT'S AND -- 7708 05:19:50,964 --> 05:19:53,033 FESTIVITIES AND WALK AWAY REALLY 7709 05:19:53,033 --> 05:19:55,268 BOTH HUMBLED AND INSPIRED AND 7710 05:19:55,268 --> 05:19:56,903 FULL OF REALISTIC OPTIMISM, IT 7711 05:19:56,903 --> 05:20:02,542 IS MY PLEASURE TO INTRODUCE OUR 7712 05:20:02,542 --> 05:20:05,178 COLLEAGUES, DR. STACY 7713 05:20:05,178 --> 05:20:07,180 CARRINGTON-LAWRENCE FROM ACTING 7714 05:20:07,180 --> 05:20:08,682 DIRECTOR AT THE DIVISION OF 7715 05:20:08,682 --> 05:20:10,117 AGING BIOLOGY, WHO IS GOING ON 7716 05:20:10,117 --> 05:20:11,551 SHARE WITH US THE HIGHLIGHTS AND 7717 05:20:11,551 --> 05:20:17,224 KEY TAKE AWAYS OF THE 7718 05:20:17,224 --> 05:20:19,126 GEROSCIENCE SUMMIT THAT WAS HELD 7719 05:20:19,126 --> 05:20:19,759 RECENTLY. 7720 05:20:19,759 --> 05:20:22,295 FOLLOWING HER PRESENTATION, 7721 05:20:22,295 --> 05:20:25,465 DR. ERIN HARRELL, DIRECTOR OF 7722 05:20:25,465 --> 05:20:26,233 BEHAVIORAL SOCIAL RESEARCH WILL 7723 05:20:26,233 --> 05:20:28,301 SHARE WITH US THE KEY TAKE AWAYS 7724 05:20:28,301 --> 05:20:29,069 AND HIGHLIGHTS FROM THE 7725 05:20:29,069 --> 05:20:31,138 COGNITIVE AGING SUMMIT THAT WAS 7726 05:20:31,138 --> 05:20:32,606 ALSO HELD RECENTLY. 7727 05:20:32,606 --> 05:20:34,007 AND THE REASON BEING WE REALLY 7728 05:20:34,007 --> 05:20:37,844 WANT TO ILLUSTRATE NIA'S 7729 05:20:37,844 --> 05:20:39,846 COMPREHENSIVE APPROACH AND 7730 05:20:39,846 --> 05:20:41,548 INTEGRATIVE APPROACH IN BRINGING 7731 05:20:41,548 --> 05:20:45,185 TOGETHER THE INVESTIGATION OF 7732 05:20:45,185 --> 05:20:47,053 AGING, AGE RELATED DISORDERS, 7733 05:20:47,053 --> 05:20:48,355 OUTSIDE OF ALZHEIMER'S AND 7734 05:20:48,355 --> 05:20:50,423 RELATED DEMENTIAS, AND IN ALL 7735 05:20:50,423 --> 05:20:55,562 THESE DIMENSIONS, INCLUDING 7736 05:20:55,562 --> 05:20:59,199 OBVIOUSLY -- SO THANK YOU, 7737 05:20:59,199 --> 05:21:00,834 STACY, AND THE PODIUM IS YOURS. 7738 05:21:00,834 --> 05:21:02,736 >> GREAT, THANK YOU, SUZANNA. 7739 05:21:02,736 --> 05:21:04,104 I HOPE EVERYONE IS ABLE TO HEAR 7740 05:21:04,104 --> 05:21:04,938 ME OKAY. 7741 05:21:04,938 --> 05:21:06,072 >> YES. 7742 05:21:06,072 --> 05:21:08,041 >> OKAY. 7743 05:21:08,041 --> 05:21:09,809 SO AGAIN, GOOD AFTERNOON, 7744 05:21:09,809 --> 05:21:10,076 EVERYONE. 7745 05:21:10,076 --> 05:21:14,147 I WANT TO THANK SUZANNA, ERIKA, 7746 05:21:14,147 --> 05:21:16,917 AS WELL AS LAURIE FOR INVITING 7747 05:21:16,917 --> 05:21:18,418 ME OR GIVING ME THE OPPORTUNITY 7748 05:21:18,418 --> 05:21:21,254 SHARE A BRIEF SUMMARY OF THE 7749 05:21:21,254 --> 05:21:22,455 FOURTH GEROSCIENCE SUMMIT THAT 7750 05:21:22,455 --> 05:21:26,626 WAS SPONSORED BY NIA BACK IN 7751 05:21:26,626 --> 05:21:26,826 2023. 7752 05:21:26,826 --> 05:21:28,628 SO FIRST, I'LL GIVE SORT OF A 7753 05:21:28,628 --> 05:21:30,931 BRIEF OVERVIEW OF GEROSCIENCE. 7754 05:21:30,931 --> 05:21:32,098 I KNOW MANY OF YOU PROBABLY 7755 05:21:32,098 --> 05:21:33,433 ALREADY KNOW WHAT IT IS, BUT FOR 7756 05:21:33,433 --> 05:21:34,768 THOSE WHO DON'T, I'LL JUST 7757 05:21:34,768 --> 05:21:36,937 BRIEFLY GO THROUGH IT, THEN I 7758 05:21:36,937 --> 05:21:38,238 WILL TALK ABOUT SOME ACTIVITIES 7759 05:21:38,238 --> 05:21:41,074 THAT ARE GOING ON AT NIH IN 7760 05:21:41,074 --> 05:21:43,843 RESPONSE TO GEROSCIENCE, AS WELL 7761 05:21:43,843 --> 05:21:46,346 AS THE OVERVIEW OF THE SUMMIT 7762 05:21:46,346 --> 05:21:50,083 THAT WE RECENTLY HAD. 7763 05:21:50,083 --> 05:21:51,918 SO BRIEFLY, THE GEROSCIENCE 7764 05:21:51,918 --> 05:21:53,987 HYPOTHESIS ASSERTS THAT ANY 7765 05:21:53,987 --> 05:21:55,188 INTERVENTIONS THAT SLOW THE 7766 05:21:55,188 --> 05:21:56,723 AGING PROCESS WILL DELAY THE 7767 05:21:56,723 --> 05:21:58,491 ONSET OF MULTIPLE AGE RELATED 7768 05:21:58,491 --> 05:22:00,227 DISEASES AND FUNCTIONAL 7769 05:22:00,227 --> 05:22:00,794 DECLINES. 7770 05:22:00,794 --> 05:22:03,430 HOWEVER, TESTING HYPOTHESIS AND 7771 05:22:03,430 --> 05:22:04,497 APPLYING THE KNOWLEDGE GAINED 7772 05:22:04,497 --> 05:22:05,932 ARE COMPLICATED BY A MULTITUDE 7773 05:22:05,932 --> 05:22:07,000 OF FACTORS. 7774 05:22:07,000 --> 05:22:11,738 THE CROSS-SCALES OF RESEARCH 7775 05:22:11,738 --> 05:22:13,039 FROM MOLECULAR TO POPULATIONS 7776 05:22:13,039 --> 05:22:15,242 RANGING FROM DIFFERENCES IN 7777 05:22:15,242 --> 05:22:17,978 MULTIMORBIDITIES RELATED TO AGE, 7778 05:22:17,978 --> 05:22:20,480 SEX, ETHNICITY, TO A COMPLEX 7779 05:22:20,480 --> 05:22:21,514 INTERPLAY AMONG MOLECULAR 7780 05:22:21,514 --> 05:22:22,882 DRIVERS OF AGING. 7781 05:22:22,882 --> 05:22:27,354 THE GOALS OF USING A GEROSCIENCE 7782 05:22:27,354 --> 05:22:28,788 APPROACH INCLUDE TO SEEK OUT 7783 05:22:28,788 --> 05:22:30,624 INTERVENTIONS THAT SLOW OR 7784 05:22:30,624 --> 05:22:33,927 REVERSE CELLULAR MOLECULAR AGE 7785 05:22:33,927 --> 05:22:35,895 RELATED CHANGES, TO VALIDATE 7786 05:22:35,895 --> 05:22:37,864 NOVEL INTERVENTIONS THAT ENGAGE 7787 05:22:37,864 --> 05:22:40,934 THE HALLMARKS OF AGING, AND TO 7788 05:22:40,934 --> 05:22:42,569 DETERMINE THEIR IMPACT ON 7789 05:22:42,569 --> 05:22:44,437 AGE-RELATED DISEASES AND OVERALL 7790 05:22:44,437 --> 05:22:46,940 FUNCTION, AS WELL AS TO SUPPORT 7791 05:22:46,940 --> 05:22:48,608 THE SPECTRUM OF TRANSLATIONAL 7792 05:22:48,608 --> 05:22:52,078 RESEARCH NEEDED TO VALIDATE 7793 05:22:52,078 --> 05:22:53,513 GEROSCIENCE INTERVENTIONS INTO 7794 05:22:53,513 --> 05:22:58,251 CLINICAL PRACTICE. 7795 05:22:58,251 --> 05:23:00,186 ONE OF THE MAJOR ACTIVITIES FOR 7796 05:23:00,186 --> 05:23:04,357 GEROSCIENCE AT NIH IS THE GSIG. 7797 05:23:04,357 --> 05:23:08,295 IN 2012 DOCTORS SIERRA AND RON 7798 05:23:08,295 --> 05:23:10,163 KOHANSKI, BOTH FORMER DIRECTORS 7799 05:23:10,163 --> 05:23:15,268 OF DWIFTION AGE -- DIVISION OF 7800 05:23:15,268 --> 05:23:19,039 AGING BIOLOGY ESTABLISHED GSIG, 7801 05:23:19,039 --> 05:23:20,006 GEROSCIENCE INTEREST GROUP. 7802 05:23:20,006 --> 05:23:21,541 THE OBJECTIVES OF THE GROUP ARE 7803 05:23:21,541 --> 05:23:22,442 TO STIMULATE INTEREST IN THE 7804 05:23:22,442 --> 05:23:26,146 BASIC SCIENCE OF AGING ACROSS 7805 05:23:26,146 --> 05:23:26,913 INSTITUTES, CENTERS AND OFFICES 7806 05:23:26,913 --> 05:23:30,650 AT NI H AND TO FACILITATE 7807 05:23:30,650 --> 05:23:31,751 EDUCATION, COMMUNICATION AND 7808 05:23:31,751 --> 05:23:32,085 COLLABORATION. 7809 05:23:32,085 --> 05:23:35,255 THE GROUP WHICH NOW INCLUDES 7810 05:23:35,255 --> 05:23:36,456 ABOUT 19 OF THE 27 INSTITUTES 7811 05:23:36,456 --> 05:23:40,493 AND CENTERS AT NIH MEETS 7812 05:23:40,493 --> 05:23:42,796 REGULARLY AND PROVIDES 7813 05:23:42,796 --> 05:23:44,564 EDUCATIONAL WEBINARS FOR NIH 7814 05:23:44,564 --> 05:23:46,966 STAFF ON TOPICS IN GEROSCIENCE, 7815 05:23:46,966 --> 05:23:48,802 CONTRIBUTES TO CONCEPTS AND 7816 05:23:48,802 --> 05:23:51,104 FUNDING OPPORTUNITIES AND 7817 05:23:51,104 --> 05:23:52,205 PUBLISHES PERSPECTIVE PAPERS ON 7818 05:23:52,205 --> 05:23:54,174 AREAS OF INTEREST TO THE 7819 05:23:54,174 --> 05:23:56,076 GEROSCIENCE COMMUNITY. 7820 05:23:56,076 --> 05:24:00,547 IN ADDITION, THE GSIG HOAS THE 7821 05:24:00,547 --> 05:24:01,848 GEROSCIENCE -- HOSTS THE 7822 05:24:01,848 --> 05:24:03,483 GEROSCIENCE SUMMITS THAT OCCUR 7823 05:24:03,483 --> 05:24:04,884 APPROXIMATELY EVERY THREE YEARS. 7824 05:24:04,884 --> 05:24:06,686 THERE HAVE BEEN FOUR SUMMITS SO 7825 05:24:06,686 --> 05:24:09,923 FAR SINCE 2013, WITH THE FOURTH 7826 05:24:09,923 --> 05:24:18,932 SUMMIT TAKING PLACE IN 2023. 7827 05:24:18,932 --> 05:24:21,668 SO NIA IN PARTNERSHIP WITH THE 7828 05:24:21,668 --> 05:24:23,069 GSIG CONVENED THE FOURTH 7829 05:24:23,069 --> 05:24:25,071 GEROSCIENCE SUMMIT ON APRIL 24 7830 05:24:25,071 --> 05:24:27,607 THROUGH THE 26 OF 2023. 7831 05:24:27,607 --> 05:24:29,142 AND THE GOAL OF THE SUMMIT WAS 7832 05:24:29,142 --> 05:24:31,311 TO EXPLORE TOPICS AT THE 7833 05:24:31,311 --> 05:24:32,545 FOREFRONT OF THE GEROSCIENCE 7834 05:24:32,545 --> 05:24:34,047 FIELD AND TO CONSIDER NOVEL WAYS 7835 05:24:34,047 --> 05:24:36,349 TO ADVANCE THIS RAPIDLY EVOLVING 7836 05:24:36,349 --> 05:24:37,684 AREA OF RESEARCH. 7837 05:24:37,684 --> 05:24:38,752 THE EVENT HIGHLIGHTED THE NEED 7838 05:24:38,752 --> 05:24:41,588 TO FURTHER DEVELOP THE FIELD IN 7839 05:24:41,588 --> 05:24:43,356 AN EQUITABLE AND INCLUSIVE WAY 7840 05:24:43,356 --> 05:24:45,091 AND HEALTH DISPARITIES IN AGING 7841 05:24:45,091 --> 05:24:46,860 WAS A CENTRAL THEME CARRIED 7842 05:24:46,860 --> 05:24:49,729 THROUGHOUT THE SUMMIT. 7843 05:24:49,729 --> 05:24:51,664 THE INTENT OF THE THREE-DAY 7844 05:24:51,664 --> 05:24:53,133 WORKSHOP WAS TO ASSESS THE 7845 05:24:53,133 --> 05:24:56,302 STATEMENT OF THE SCIENCE AND 7846 05:24:56,302 --> 05:24:57,470 GEROSCIENCE, LEARN FROM EARLY 7847 05:24:57,470 --> 05:24:59,139 AND MID CAREER RESEARCHERS 7848 05:24:59,139 --> 05:25:00,573 WORKING IN THE SPACE, CONVENE A 7849 05:25:00,573 --> 05:25:02,509 DIVERSE GROUP OF STAKEHOLDERS TO 7850 05:25:02,509 --> 05:25:03,843 FACILITATE NEW COLLABORATIONS 7851 05:25:03,843 --> 05:25:05,044 AND TO DETERMINE THE BARRIERS TO 7852 05:25:05,044 --> 05:25:10,383 PROGRESS AND EXPLORE POTENTIAL 7853 05:25:10,383 --> 05:25:10,650 SOLUTIONS. 7854 05:25:10,650 --> 05:25:12,385 THERE WERE ALSO SEVERAL 7855 05:25:12,385 --> 05:25:12,986 CHALLENGES THAT ACTUALLY DROVE 7856 05:25:12,986 --> 05:25:14,888 THE AGENDA FOR THE SUMMIT, AND 7857 05:25:14,888 --> 05:25:15,989 THEY INCLUDED THE NEED TO 7858 05:25:15,989 --> 05:25:17,824 DEVELOP AND IMPLEMENT 7859 05:25:17,824 --> 05:25:19,592 GEROSCIENCE FOR THE BENEFIT OF 7860 05:25:19,592 --> 05:25:21,461 ALL, AND THIS WOULD INCLUDE THE 7861 05:25:21,461 --> 05:25:22,562 DISCIPLINES OF PRECISION 7862 05:25:22,562 --> 05:25:24,431 MEDICINE CHRKS WE HEARD QUAIT A 7863 05:25:24,431 --> 05:25:25,765 BIT -- WHICH WE HEARD QUITE A 7864 05:25:25,765 --> 05:25:28,735 BIT ABOUT FROM YOUR SUMMIT, 7865 05:25:28,735 --> 05:25:29,803 MINORITY HEALTH AND HEALTH 7866 05:25:29,803 --> 05:25:30,770 DISPARITIES AS WELL AS THE NEED 7867 05:25:30,770 --> 05:25:33,072 FOR GEROSCIENCE RESEARCH TO 7868 05:25:33,072 --> 05:25:35,708 ADDRESS CO-MORE MID TIZ, 7869 05:25:35,708 --> 05:25:37,811 MULTIMORBIDITY AND GERIATRIC 7870 05:25:37,811 --> 05:25:38,878 SYNDROMES, ADVANCING THE 7871 05:25:38,878 --> 05:25:40,146 DEVELOPMENT OF MEASURES 7872 05:25:40,146 --> 05:25:42,649 REPORTING HEALTH AND FUNCTION IN 7873 05:25:42,649 --> 05:25:45,051 AGING, AND THE IMPORTANCE OF 7874 05:25:45,051 --> 05:25:47,654 EVIDENCE-BASED INCLUSIVE 7875 05:25:47,654 --> 05:25:48,521 GEROSCIENCE IN MEDICAL PRACTICE 7876 05:25:48,521 --> 05:25:50,390 AND FEASIBILITY DESIGN AND 7877 05:25:50,390 --> 05:25:52,325 IMPLEMENTATION OF GEROSCIENCE IN 7878 05:25:52,325 --> 05:25:54,794 CLINICAL TRIALS. 7879 05:25:54,794 --> 05:25:57,197 THEREFORE, THE AGENDA WAS BROKEN 7880 05:25:57,197 --> 05:25:58,531 OUT INTO EIGHT SESSION THEMES 7881 05:25:58,531 --> 05:26:00,600 THAT WERE DESIGNED TO ADDRESS 7882 05:26:00,600 --> 05:26:02,135 CHALLENGES IN THE FIELD. 7883 05:26:02,135 --> 05:26:04,204 ON DAY ONE, SESSIONS INCLUDED 7884 05:26:04,204 --> 05:26:05,572 THE BIOLOGICAL DETERMINANTS OF 7885 05:26:05,572 --> 05:26:08,074 HEALTH AND DISPARITIES IN AGING, 7886 05:26:08,074 --> 05:26:09,342 WHICH PROVIDED AN INTRODUCTION 7887 05:26:09,342 --> 05:26:12,312 AND OVERVIEW OF THE NIH DEATH 7888 05:26:12,312 --> 05:26:14,714 DISPARITIES FRAMEWORK FOR 7889 05:26:14,714 --> 05:26:16,483 RESEARCH -- HEALTH DISPARITIES 7890 05:26:16,483 --> 05:26:18,017 FRAMEWORK FOR RESEARCH AND 7891 05:26:18,017 --> 05:26:20,253 IMPACTS ON AGING RELATED HEALTH 7892 05:26:20,253 --> 05:26:22,188 OUTCOMES AND OVERVIEW OF BASIC 7893 05:26:22,188 --> 05:26:23,957 AND TRANSLATIONAL CANCER BIOLOGY 7894 05:26:23,957 --> 05:26:25,258 RESEARCH, UNDERSTANDING AND 7895 05:26:25,258 --> 05:26:27,126 REDUCING CANCER HEALTH 7896 05:26:27,126 --> 05:26:28,328 DISPARITIES WAS ALSO PRESENTED, 7897 05:26:28,328 --> 05:26:32,432 AND PERSPECTIVES ON FRAMING 7898 05:26:32,432 --> 05:26:33,833 FUNDAMENTAL BIOLOGICAL RESEARCH 7899 05:26:33,833 --> 05:26:35,702 TO EXPAND PROGRESS IN ADDRESS 7900 05:26:35,702 --> 05:26:38,238 HEALTH DISPARITIES OF THE AGING 7901 05:26:38,238 --> 05:26:41,875 WAS ALSO DISCUSSED. 7902 05:26:41,875 --> 05:26:43,643 THE SECOND SESSION IN DAY ONE 7903 05:26:43,643 --> 05:26:45,945 FOLK TUSKED ON POPULATIONS FOR 7904 05:26:45,945 --> 05:26:47,814 GEROSCIENCE RESEARCH -- FOCUSED 7905 05:26:47,814 --> 05:26:48,248 ON. 7906 05:26:48,248 --> 05:26:49,782 THIS FOCUSED ON STUDIES THAT 7907 05:26:49,782 --> 05:26:51,551 REVEALED DIFFERENCES RELATED TO 7908 05:26:51,551 --> 05:26:53,052 CHARACTERISTICS, DIFFERENCES IN 7909 05:26:53,052 --> 05:26:55,788 RATES OF AGING RELATED TO 7910 05:26:55,788 --> 05:26:57,690 CHARACTERISTICS SUCH AS FAMILIAL 7911 05:26:57,690 --> 05:27:00,260 LIFE SPAN, EARLY DISEASE OR 7912 05:27:00,260 --> 05:27:02,362 CHRONIC INFECTION, AS WELL AS 7913 05:27:02,362 --> 05:27:04,898 WITHIN POPULATION HETEROGENEITY 7914 05:27:04,898 --> 05:27:07,834 AND RATES OF AGING. 7915 05:27:07,834 --> 05:27:09,469 THERE WERE REPORTS FROM SEVERAL 7916 05:27:09,469 --> 05:27:12,839 MAJOR FINDINGS FROM THESE WELL 7917 05:27:12,839 --> 05:27:13,873 STUDIED POPULATIONS THAT WERE 7918 05:27:13,873 --> 05:27:15,141 PRESENTED DURING THE SESSION IN 7919 05:27:15,141 --> 05:27:18,311 ORDER TO EXPLORE HOW THESE 7920 05:27:18,311 --> 05:27:19,646 STUDIES MIGHT BE FORMED -- MIGHT 7921 05:27:19,646 --> 05:27:21,514 INFORM BIOLOGICAL RESEARCH AND 7922 05:27:21,514 --> 05:27:22,382 HEALTH DISPARITIES. 7923 05:27:22,382 --> 05:27:27,220 AND FINALLY, ON DAY ONE, OH, 7924 05:27:27,220 --> 05:27:31,257 SORRY, I'LL TRY AND GO BACK. 7925 05:27:31,257 --> 05:27:32,926 MULTIMORBIDITIES AND GERIATRIC 7926 05:27:32,926 --> 05:27:34,360 SYNDROMES TO EXPLORE THE IDEA 7927 05:27:34,360 --> 05:27:36,529 THAT BOTH MULTIMORBIDITY AND 7928 05:27:36,529 --> 05:27:38,531 GERIATRIC SYNDROMES ARE EMERGENT 7929 05:27:38,531 --> 05:27:41,134 PROPERTIES OF UNDERLYING GLOBAL 7930 05:27:41,134 --> 05:27:41,434 INSTABILITY. 7931 05:27:41,434 --> 05:27:43,169 THAT IS INTRINSICALLY CEKED WITH 7932 05:27:43,169 --> 05:27:45,271 THE BIOLOGY OF THE AGING. 7933 05:27:45,271 --> 05:27:46,272 AND ONE OF THE CRITICAL 7934 05:27:46,272 --> 05:27:47,473 QUESTIONS THAT WAS ADDRESSED IN 7935 05:27:47,473 --> 05:27:50,977 THIS SESSION WAS HOW WE CAN USE 7936 05:27:50,977 --> 05:27:52,946 OTHER MORE RELEVANT ANIMAL 7937 05:27:52,946 --> 05:27:54,781 MODELS FOR GEROSCIENCE RESEARCH 7938 05:27:54,781 --> 05:27:57,216 ON MULTIMORBIDITIES AND 7939 05:27:57,216 --> 05:27:58,084 GERIATRIC SYNDROMES. 7940 05:27:58,084 --> 05:27:59,519 DAY TWO SESSIONS INCLUDED 7941 05:27:59,519 --> 05:28:01,254 METHODS FOR MEASURING HEALTH, 7942 05:28:01,254 --> 05:28:02,922 THE SESSION EXPLORED DIFFERENT 7943 05:28:02,922 --> 05:28:04,357 METHODS FOR MEASURING HEALTH 7944 05:28:04,357 --> 05:28:06,526 ACROSS THE LIFE SPAN INCLUDING 7945 05:28:06,526 --> 05:28:07,827 DEFICIT ACCUMULATION AND FRAILTY 7946 05:28:07,827 --> 05:28:10,897 IN DISEASE, AS WELL AS GERIATRIC 7947 05:28:10,897 --> 05:28:13,666 MOBILITY ASSESSMENTS. 7948 05:28:13,666 --> 05:28:14,734 MATHEMATICAL MODELING OF AGING 7949 05:28:14,734 --> 05:28:16,736 AND HEALTH FOR GEROSCIENCE. 7950 05:28:16,736 --> 05:28:18,471 THIS SESSION FOCUSED ON MODELING 7951 05:28:18,471 --> 05:28:20,440 TO ASSESS WHICH LIFE CONDITIONS 7952 05:28:20,440 --> 05:28:22,742 OR INTERVENTIONS SLOW OR 7953 05:28:22,742 --> 05:28:24,911 ACCELERATE AGING. 7954 05:28:24,911 --> 05:28:26,446 ESPECIALLY IN THE CONTEXT OF 7955 05:28:26,446 --> 05:28:28,748 CLINICAL OUTCOMES, WITH THE GOAL 7956 05:28:28,748 --> 05:28:30,416 OF IDENTIFYING PARAMETERS TO 7957 05:28:30,416 --> 05:28:31,951 MEASURE RATES OF AGING AS WELL 7958 05:28:31,951 --> 05:28:35,054 AS TO INDICATE WHICH TYPES OF 7959 05:28:35,054 --> 05:28:37,423 INTERVENTIONS MAY BE MOST 7960 05:28:37,423 --> 05:28:39,292 EFFECTIVE IN CHANGING RATES OF 7961 05:28:39,292 --> 05:28:39,492 AGING. 7962 05:28:39,492 --> 05:28:43,329 AND THE FINAL SESSION ON DAY TWO 7963 05:28:43,329 --> 05:28:45,098 FOCUSED ON CHALLENGES IN THE 7964 05:28:45,098 --> 05:28:47,634 DEVELOPMENT OF BIOMARKERS FOR 7965 05:28:47,634 --> 05:28:49,268 AGING AND GEROSCIENCE. 7966 05:28:49,268 --> 05:28:52,005 THESE CHALLENGES INCLUDE A 7967 05:28:52,005 --> 05:28:53,306 COMPLEX HETEROGENEITY AND ANY 7968 05:28:53,306 --> 05:28:54,807 HEALTH METRIC WHEN MEASURED 7969 05:28:54,807 --> 05:28:55,942 AGAINST AGE. 7970 05:28:55,942 --> 05:28:58,444 VARIATION IN ORGAN AND TISSUE 7971 05:28:58,444 --> 05:28:59,746 FUNCTION COMPARED BETWEEN 7972 05:28:59,746 --> 05:29:01,614 INDIVIDUALS AND VARIATIONS IN 7973 05:29:01,614 --> 05:29:03,016 LIFE HISTORIES THAT IMPACT 7974 05:29:03,016 --> 05:29:07,420 HEALTH AT ANY AGE. 7975 05:29:07,420 --> 05:29:08,621 THESE MAY IMPACT HEALTH IN WAYS 7976 05:29:08,621 --> 05:29:12,225 THAT MAY BE ADAPTIVE OR 7977 05:29:12,225 --> 05:29:13,026 MALADAPTIVE. 7978 05:29:13,026 --> 05:29:14,761 WE FINISHED ON DAY THREE WITH 7979 05:29:14,761 --> 05:29:15,728 TWO SESSIONS. 7980 05:29:15,728 --> 05:29:17,096 ONE ON GEROSCIENCE AS MEDICINE 7981 05:29:17,096 --> 05:29:19,232 IN THE CLINIC AND THE COMMUNITY, 7982 05:29:19,232 --> 05:29:20,800 WHICH HAD PRESENTATIONS THAT 7983 05:29:20,800 --> 05:29:21,901 DISCUSSED AREAS IN WHICH 7984 05:29:21,901 --> 05:29:24,771 GEROSCIENCE COULD ADVANCE CARE 7985 05:29:24,771 --> 05:29:27,273 OF OLDER ADULTS WITH THE GOAL TO 7986 05:29:27,273 --> 05:29:28,141 FACILITATE COMMUNICATION AMONG 7987 05:29:28,141 --> 05:29:30,143 RESEARCHERS AND PROVIDERS AND 7988 05:29:30,143 --> 05:29:31,110 THEIR PATIENTS, AS WELL AS TO 7989 05:29:31,110 --> 05:29:32,445 IMPROVE OUR UNDERSTANDING AND 7990 05:29:32,445 --> 05:29:34,714 INTEGRATION OF GEROSCIENCE IN 7991 05:29:34,714 --> 05:29:37,350 CLINICAL PRACTICE OR PATIENT 7992 05:29:37,350 --> 05:29:37,784 CARE. 7993 05:29:37,784 --> 05:29:39,852 THE FINAL SESSION ON DAY THREE 7994 05:29:39,852 --> 05:29:42,622 WAS ON GEROSCIENCE CLINICAL 7995 05:29:42,622 --> 05:29:43,022 TRIALS. 7996 05:29:43,022 --> 05:29:44,691 THIS SESSION TIMED ADDRESS THE 7997 05:29:44,691 --> 05:29:46,426 CHALLENGES ASSOCIATED WITH 7998 05:29:46,426 --> 05:29:47,527 DEVELOPING AND CARRYING OUT 7999 05:29:47,527 --> 05:29:48,961 GEROSCIENCE BASED CLINICAL 8000 05:29:48,961 --> 05:29:50,930 TRIALS THAT ARE INCLUSIVE AND 8001 05:29:50,930 --> 05:29:53,666 INCORPORATE SOCIAL DETERMINANTS 8002 05:29:53,666 --> 05:29:55,735 OF HEALTH, IN ORDER TO TEST 8003 05:29:55,735 --> 05:29:57,136 INTERVENTION THAT IS CAN AFFECT 8004 05:29:57,136 --> 05:29:59,238 MULTIPLE CONDITIONS OF AGING. 8005 05:29:59,238 --> 05:30:01,741 SO OVERALL, THE SPEAKERS AND 8006 05:30:01,741 --> 05:30:02,408 PANELISTS RECOMMENDED SEVERAL 8007 05:30:02,408 --> 05:30:03,376 THINGS TO KEEP IN MIND AND TO 8008 05:30:03,376 --> 05:30:05,478 AIM FOR IN THE FUTURE AND SOME 8009 05:30:05,478 --> 05:30:08,448 OF THESE WILL PROBABLY BE VERY 8010 05:30:08,448 --> 05:30:10,717 FAMILIAR TO YOU ALL. 8011 05:30:10,717 --> 05:30:12,151 I'VE HEARD ABOUT THIS SEVERAL 8012 05:30:12,151 --> 05:30:15,088 TIMES OVER THE COURSE OF THE AD 8013 05:30:15,088 --> 05:30:15,321 SUMMIT. 8014 05:30:15,321 --> 05:30:17,857 AND THAT IS, GIVEN HETEROGENEITY 8015 05:30:17,857 --> 05:30:20,226 IN AGING, INCLUDING DIFFERENT 8016 05:30:20,226 --> 05:30:24,964 LIFE CONTEXTS, PANELISTS AND 8017 05:30:24,964 --> 05:30:26,065 SPEAKERS THOUGHT PRECISION 8018 05:30:26,065 --> 05:30:30,002 MEDICINE WOULD BETTER TAILOR 8019 05:30:30,002 --> 05:30:31,337 THERAPEUTIC INTERVENTIONS THAT 8020 05:30:31,337 --> 05:30:33,673 WOULD BE APPLICABLE TO A LARGE 8021 05:30:33,673 --> 05:30:36,175 PROPORTION OF THE POPULATION. 8022 05:30:36,175 --> 05:30:37,810 THEY ALSO RECOMMENDED MOVING WAY 8023 05:30:37,810 --> 05:30:40,079 FROM SINGLE DISEASE RESPONSES 8024 05:30:40,079 --> 05:30:42,582 AND MORE TOWARDS STRUCTURAL 8025 05:30:42,582 --> 05:30:44,484 CHANGE, MULTILEVEL 8026 05:30:44,484 --> 05:30:46,119 INTERVENTIONS, AND 8027 05:30:46,119 --> 05:30:47,286 INTERDISCIPLINARY APPROACHES. 8028 05:30:47,286 --> 05:30:48,521 THEY ALSO STRESSED THE 8029 05:30:48,521 --> 05:30:50,156 IMPORTANCE OF DEVELOPING ACROSS 8030 05:30:50,156 --> 05:30:52,358 SPEE -- A CROSS-SPECIES 8031 05:30:52,358 --> 05:30:53,793 FRAMEWORK TO TRANSLATE INSIGHTS 8032 05:30:53,793 --> 05:30:56,095 GAINED FROM ANIMAL MODELS TO THE 8033 05:30:56,095 --> 05:30:56,629 CLINIC. 8034 05:30:56,629 --> 05:30:58,164 PRESENTERS ALSO MENTIONED AGING 8035 05:30:58,164 --> 05:31:00,333 BEING A SERIES OF OUTCOMES WITH 8036 05:31:00,333 --> 05:31:02,802 DIVERSE CONTRIBUTING FACTORS. 8037 05:31:02,802 --> 05:31:04,270 RATHER THAN A SET OF OUTCOMES 8038 05:31:04,270 --> 05:31:06,139 ARISE FRG A SMALL SET OF 8039 05:31:06,139 --> 05:31:08,007 PROCESSES, AGING OUTCOMES ARE 8040 05:31:08,007 --> 05:31:09,842 LIKELY SHAPED IN COMPLEX WAYS BY 8041 05:31:09,842 --> 05:31:12,678 A LARGE NUMBER OF FACTORS AND 8042 05:31:12,678 --> 05:31:14,447 MORE ACCURATELY MODELING OF 8043 05:31:14,447 --> 05:31:16,282 AGING WILL BE IMPORTANT TO 8044 05:31:16,282 --> 05:31:22,188 ADVANCE GEROSCIENCE. 8045 05:31:22,188 --> 05:31:23,089 FINALLY, BIOMARKERS WERE ALSO 8046 05:31:23,089 --> 05:31:24,390 DISCUSSED QUITE A BIT AND 8047 05:31:24,390 --> 05:31:26,793 PRESENTERS INDICATED THAT 8048 05:31:26,793 --> 05:31:28,161 BIOMARKERS SHOULD BE 8049 05:31:28,161 --> 05:31:29,762 MULTIFACTORIAL AND HAVE MEASURED 8050 05:31:29,762 --> 05:31:31,631 THAT ARE SHORT -- HAVE MEASURES 8051 05:31:31,631 --> 05:31:32,832 THAT SHORT-TERM FOR CLINICAL 8052 05:31:32,832 --> 05:31:34,267 TRIALS, BE PREDICTORS OF 8053 05:31:34,267 --> 05:31:39,172 DISEASE, SO BEFORE THE ONSET OF 8054 05:31:39,172 --> 05:31:41,040 DISEASE, INDICATE CURRENT HEALTH 8055 05:31:41,040 --> 05:31:42,775 VERSUS FUTURE HEALTH, VERSUS 8056 05:31:42,775 --> 05:31:46,612 TRAJECTORIES OF AGING, 8057 05:31:46,612 --> 05:31:49,015 BIOMARKERS SHOULD IDENTIFY 8058 05:31:49,015 --> 05:31:50,116 ORGANISM HEALTH VERSUS 8059 05:31:50,116 --> 05:31:52,218 CRECIALTION ORGAN OR DISEASE 8060 05:31:52,218 --> 05:31:53,820 SPECIFIC -- CRECIALTION ORGAN OR 8061 05:31:53,820 --> 05:31:56,689 DISEASE SPECIFIC, DISEASE 8062 05:31:56,689 --> 05:31:58,224 SPECIFIC VERSUS HALLMARK 8063 05:31:58,224 --> 05:31:59,425 SPECIFIC FACTORS, AND ALSO THE 8064 05:31:59,425 --> 05:32:02,628 PANELISTS AND SPEAKERS OF THE 8065 05:32:02,628 --> 05:32:04,130 SUMMIT STRESSED THE NEED TO MORE 8066 05:32:04,130 --> 05:32:05,464 CAREFULLY CONSIDER THE 8067 05:32:05,464 --> 05:32:06,966 STRATIFICATION OF PATIENTS FOR 8068 05:32:06,966 --> 05:32:08,167 INTERVENTIONS IN THE TRACKING OF 8069 05:32:08,167 --> 05:32:12,438 RESPONSES TO INTERVENTIONS. 8070 05:32:12,438 --> 05:32:13,105 SO THERE WERE SEVERAL 8071 05:32:13,105 --> 05:32:15,408 OPPORTUNITIES THAT WERE ALSO 8072 05:32:15,408 --> 05:32:17,043 IDENTIFIED FOR GEROSCIENCE 8073 05:32:17,043 --> 05:32:18,644 RESEARCH, INCLUDING DESIGNING 8074 05:32:18,644 --> 05:32:21,447 MULTILEVEL AFROACHES ADDRESS AGE 8075 05:32:21,447 --> 05:32:22,949 RELATED -- TO ADDRESS -- MURLT 8076 05:32:22,949 --> 05:32:25,451 LEVEL APPROACHES TO ADDRESS AGE 8077 05:32:25,451 --> 05:32:28,087 RELATED HEALTH DISSPARES, 8078 05:32:28,087 --> 05:32:29,088 EXPLORING AND TESTING 8079 05:32:29,088 --> 05:32:31,257 GEROSCIENCE BASED INTERVENTIONS 8080 05:32:31,257 --> 05:32:32,892 FOR CHRONIC DISEASE PATIENTS AND 8081 05:32:32,892 --> 05:32:33,659 SURVIVORS, DEVELOPING RESEARCH 8082 05:32:33,659 --> 05:32:36,395 MODELS TO STUDY AND TREAT 8083 05:32:36,395 --> 05:32:38,464 MULTIMORBIDITY, IDENTIFYING AND 8084 05:32:38,464 --> 05:32:40,766 IMPLEMENTING AGE RELATED HEALTH 8085 05:32:40,766 --> 05:32:42,535 OUTCOME MEASURES, DEVELOPING AND 8086 05:32:42,535 --> 05:32:44,070 VALIDATE PREDICTIVE BIOMARKERS 8087 05:32:44,070 --> 05:32:48,007 OF AGING, AND QUITE IMPORTANT 8088 05:32:48,007 --> 05:32:49,642 AND SOMETHING I THINK THAT WE 8089 05:32:49,642 --> 05:32:51,611 DON'T DO ENOUGH OF IS TO IMPROVE 8090 05:32:51,611 --> 05:32:53,312 OUR COMMUNICATION AND TRAINING 8091 05:32:53,312 --> 05:32:56,749 IN THE GEROSCIENCE SPACE. 8092 05:32:56,749 --> 05:32:58,517 FINALLY, I WANTED TO CALL YOUR 8093 05:32:58,517 --> 05:33:00,553 ATTENTION TO A SPECIAL ISSUE OF 8094 05:33:00,553 --> 05:33:03,089 THE JOURNAL OF GERONTOLOGY. 8095 05:33:03,089 --> 05:33:04,757 IT CONTAINS SEVERAL ARTICLES 8096 05:33:04,757 --> 05:33:06,926 FROM PARTICIPANTS OF THE FOURTH 8097 05:33:06,926 --> 05:33:08,995 SUMMIT AND IT WAS RECENTLY 8098 05:33:08,995 --> 05:33:11,297 RELEASED ABOUT A WEEK OR TWO 8099 05:33:11,297 --> 05:33:13,165 AGO, AND IT CAN BE ACCESSED 8100 05:33:13,165 --> 05:33:15,167 USING THE QR CODE ON THE SCREEN. 8101 05:33:15,167 --> 05:33:16,335 I WANT TO AGAIN THANK YOU FOR 8102 05:33:16,335 --> 05:33:18,504 YOUR TIME AND ATTENTION, I'M 8103 05:33:18,504 --> 05:33:21,440 HAPPY TO ANSWER ANY QUESTIONS. 8104 05:33:21,440 --> 05:33:23,175 >> THANK YOU, STACY, THANK YOU 8105 05:33:23,175 --> 05:33:23,576 VERY MUCH. 8106 05:33:23,576 --> 05:33:30,383 NOW IT'S MY PLEASURE TO INVITE 8107 05:33:30,383 --> 05:33:33,152 ERIN HARRELL TO PRESENT THE 8108 05:33:33,152 --> 05:33:34,654 HIGHLIGHTS FROM THE COGNITIVE 8109 05:33:34,654 --> 05:33:42,261 AGING SUMMIT. 8110 05:33:42,261 --> 05:33:43,596 >> GOOD AFTERNOON, EVERYONE. 8111 05:33:43,596 --> 05:33:46,332 IT'S A PLEASURE TO BE HERE TODAY 8112 05:33:46,332 --> 05:33:47,867 TO PRESENT SOME OF THE KEY TAKE 8113 05:33:47,867 --> 05:33:49,835 AWAYS FROM THE COGNITIVE AGING 8114 05:33:49,835 --> 05:33:50,069 SUMMIT. 8115 05:33:50,069 --> 05:33:52,505 I AM DR. ERIN HARRELL FROM THE 8116 05:33:52,505 --> 05:33:54,006 DIVISION OF BEHAVIORAL AND 8117 05:33:54,006 --> 05:33:56,175 SOCIAL RESEARCH, AND I WOULD 8118 05:33:56,175 --> 05:33:59,178 LIKE TO START BY JUST GIVING A 8119 05:33:59,178 --> 05:34:02,515 LITTLE BIT OF BACKGROUND ABOUT 8120 05:34:02,515 --> 05:34:06,619 THE COGNITIVE AGING SUMMIT. 8121 05:34:06,619 --> 05:34:08,220 SO THE COGNITIVE AGING SUMMITS 8122 05:34:08,220 --> 05:34:09,989 ARE MADE POSSIBLE DUE TO THE 8123 05:34:09,989 --> 05:34:12,291 McKNIGHT BRAIN RESEARCH 8124 05:34:12,291 --> 05:34:13,392 FOUNDATION'S DECADE LONG 8125 05:34:13,392 --> 05:34:14,961 PARTNERSHIP WITH THE FOUNDATION 8126 05:34:14,961 --> 05:34:17,730 FOR THE NATIONAL INSTITUTES OF 8127 05:34:17,730 --> 05:34:17,997 HEALTH. 8128 05:34:17,997 --> 05:34:19,966 THE MISSION OF THE McKNIGHT 8129 05:34:19,966 --> 05:34:22,268 BRAIN RESEARCH FOUNDATION IS TO 8130 05:34:22,268 --> 05:34:24,770 BETTER UNDERSTAND AND ALLEVIATE 8131 05:34:24,770 --> 05:34:26,505 AGE-RELATED COGNITIVE DECLINE 8132 05:34:26,505 --> 05:34:27,840 AND MEMORY LOSS, AND THIS 8133 05:34:27,840 --> 05:34:29,141 MISSION HAS LED TO FOUR 8134 05:34:29,141 --> 05:34:31,544 COGNITIVE AGING SUMMITS WITH 8135 05:34:31,544 --> 05:34:33,245 JOINT COLLABORATIONS BETWEEN THE 8136 05:34:33,245 --> 05:34:34,647 DIVISION OF NEUROSCIENCE AND THE 8137 05:34:34,647 --> 05:34:36,482 DIVISION OF BEHAVIORAL AND 8138 05:34:36,482 --> 05:34:42,221 SOCIAL RESEARCH. 8139 05:34:42,221 --> 05:34:43,389 UNLIKE CONFERENCES THAT 8140 05:34:43,389 --> 05:34:44,924 GENERALLY TAKE PLACE EVERY YEAR, 8141 05:34:44,924 --> 05:34:46,559 EVEN THE GEROSCIENCE SUMMITS 8142 05:34:46,559 --> 05:34:48,427 THAT TAKE PLACE GENERALLY EVERY 8143 05:34:48,427 --> 05:34:51,430 THREE YEARS, THE COGNITIVE AGING 8144 05:34:51,430 --> 05:34:52,798 SUMMITS DO NOT OCCUR EVERY YEAR 8145 05:34:52,798 --> 05:34:54,900 EVEN ON A REGULAR BASIS. 8146 05:34:54,900 --> 05:34:57,269 IN FACT, THE LAST SUMMIT TOOK 8147 05:34:57,269 --> 05:35:00,039 PLACE SEVEN YEARS AGO IN 2017 8148 05:35:00,039 --> 05:35:02,575 AND WAS FOCUSED ON COGNITIVE 8149 05:35:02,575 --> 05:35:04,410 RESILIENCE AND RESERVE. 8150 05:35:04,410 --> 05:35:07,046 AS WITH THE FIRST AND SECOND 8151 05:35:07,046 --> 05:35:10,016 SUMMITS, OUTCOMES FROM SUMMIT 8152 05:35:10,016 --> 05:35:11,884 THREE INCLUDED A SPECIAL ISSUE 8153 05:35:11,884 --> 05:35:13,953 IN NEUROBIOLOGY OF AGING WITH 8154 05:35:13,953 --> 05:35:15,488 PAPERS RELATED TO EACH SESSION 8155 05:35:15,488 --> 05:35:19,291 OF THE SUMMIT AND ALSO THE RFA 8156 05:35:19,291 --> 05:35:20,593 WHICH YOU MIGHT RECALL HAVING 8157 05:35:20,593 --> 05:35:23,329 BEEN MENTIONED DURING SESSION 8158 05:35:23,329 --> 05:35:24,764 ONE WHEN SOMEONE WAS TALKING 8159 05:35:24,764 --> 05:35:29,668 ABOUT THE COGNITIVE SUPER AGERS. 8160 05:35:29,668 --> 05:35:31,103 CO-SPONSORED BY THE McKNIGHT 8161 05:35:31,103 --> 05:35:32,438 BRAIN RESEARCH FOUNDATION, THE 8162 05:35:32,438 --> 05:35:34,040 RFA WAS AN OUTGROWTH OF THE 8163 05:35:34,040 --> 05:35:36,909 SUMMIT AND FOCUSED ON RESERVE 8164 05:35:36,909 --> 05:35:38,310 AND RESILIENCE. 8165 05:35:38,310 --> 05:35:40,279 TITLED NETWORK FOR 8166 05:35:40,279 --> 05:35:41,280 IDENTIFICATION, EVALUATION AND 8167 05:35:41,280 --> 05:35:43,449 TRACKING OF OLDER PERSONS WITH 8168 05:35:43,449 --> 05:35:45,317 SUPERIOR COGNITIVE PERFORMANCE 8169 05:35:45,317 --> 05:35:47,620 FOR THEIR CHRONOLOGICAL AGE, 8170 05:35:47,620 --> 05:35:50,489 THIS INITIAL TIFER SUPPORTS TWO 8171 05:35:50,489 --> 05:35:53,426 NETWORKS TO IDENTIFY AND FOLLOW 8172 05:35:53,426 --> 05:35:55,327 COGNITIVE SUPER AGERS AND 8173 05:35:55,327 --> 05:35:56,962 CONDUCT RESEARCH ACROSS MULTIPLE 8174 05:35:56,962 --> 05:36:00,599 SITES ON ADULTS 85 YEARS AND 8175 05:36:00,599 --> 05:36:01,901 OLDER WITH COGNITIVE PERFORMANCE 8176 05:36:01,901 --> 05:36:04,303 SIMILAR TO THOSE 20 TO 30 YEARS 8177 05:36:04,303 --> 05:36:05,304 YOUNGER THAN THEM. 8178 05:36:05,304 --> 05:36:07,139 ALTHOUGH THESE COGNITIVE SUPER 8179 05:36:07,139 --> 05:36:08,808 AGERS ARE BELIEVED TO CONSTITUTE 8180 05:36:08,808 --> 05:36:13,179 A VERY SMALL MINORITY OF THE 8181 05:36:13,179 --> 05:36:15,481 POPULATION, THEY REPRESENT AN 8182 05:36:15,481 --> 05:36:16,148 UNPARALLELED RESOURCE FOR US TO 8183 05:36:16,148 --> 05:36:19,318 BE ABLE TO STUDY THE BEHAVIORAL, 8184 05:36:19,318 --> 05:36:21,053 ENVIRONMENTAL, HEALTH, NEURAL 8185 05:36:21,053 --> 05:36:23,489 AND GENETIC PROFILES OF OLDER 8186 05:36:23,489 --> 05:36:25,024 INDIVIDUALS THAT LEAD TO 8187 05:36:25,024 --> 05:36:26,859 SUPERIOR COGNITIVE AND BRAIN 8188 05:36:26,859 --> 05:36:31,997 FUNCTION IN ADVANCED AGE. 8189 05:36:31,997 --> 05:36:33,999 SO LET'S TAKE A LOOK AT THIS 8190 05:36:33,999 --> 05:36:34,633 YEAR'S SUMMIT. 8191 05:36:34,633 --> 05:36:36,502 SO SUMMIT FOUR TOOK PLACE IN 8192 05:36:36,502 --> 05:36:38,604 MARCH OF THIS YEAR, AND FFS 8193 05:36:38,604 --> 05:36:39,939 FOCUSED ON PRECISION DAIRK AND 8194 05:36:39,939 --> 05:36:41,740 IT WAS FOCUSED ON PRECISION 8195 05:36:41,740 --> 05:36:43,609 AGING AND BRAIN HEALTH, EXPLORED 8196 05:36:43,609 --> 05:36:46,879 AGE RELATED COGNITIVE CHANGE, 8197 05:36:46,879 --> 05:36:48,314 FOIKSING ON INDIVIDUAL 8198 05:36:48,314 --> 05:36:49,048 DIFFERENCES AND THE DEVELOPMENT 8199 05:36:49,048 --> 05:36:51,016 OF PERSONAL BIASED APPROACHES 8200 05:36:51,016 --> 05:36:52,017 FOR NEW YORK STOCK EXCHANGE OR 8201 05:36:52,017 --> 05:36:53,486 GAINING COGNITIVE HEALTH. 8202 05:36:53,486 --> 05:36:56,122 THE SUMMIT WAS COMPRISED OF SIX 8203 05:36:56,122 --> 05:36:57,890 SESSIONS WHICH I WILL BRIEFLY 8204 05:36:57,890 --> 05:37:01,060 DISCUSS AND HIGHLIGHT SHORTLY. 8205 05:37:01,060 --> 05:37:02,695 BUT THERE WILL ALSO BE A SPECIAL 8206 05:37:02,695 --> 05:37:04,096 ISSUE WITH MORE IN DEPTH 8207 05:37:04,096 --> 05:37:05,531 ARTICLES RELATED TO EACH SESSION 8208 05:37:05,531 --> 05:37:07,166 THAT WILL BE PUBLISHED IN THE 8209 05:37:07,166 --> 05:37:09,268 NAWR OH BIOLOGY OF AGING. 8210 05:37:09,268 --> 05:37:10,803 IN THE INTERIM, I DO ENCOURAGE 8211 05:37:10,803 --> 05:37:12,338 YOU TO VISIT OUR WEBSITE AND 8212 05:37:12,338 --> 05:37:15,074 REVIEW OUR EXECUTIVE SUMMARY AND 8213 05:37:15,074 --> 05:37:16,475 SESSION VIDEO RECORDINGS FOR 8214 05:37:16,475 --> 05:37:18,677 MORE DETAILED INFORMATION. 8215 05:37:18,677 --> 05:37:20,412 AND THERE IS A QR CODE THERE 8216 05:37:20,412 --> 05:37:24,350 THAT WILL TAKE YOU TO OUR SITE. 8217 05:37:24,350 --> 05:37:26,785 SO NOW I'LL JUST START BY GIVING 8218 05:37:26,785 --> 05:37:28,454 SOME BRIEF HIGHLIGHTS FROM EACH 8219 05:37:28,454 --> 05:37:30,055 SESSION, STARTING WITH SESSION 8220 05:37:30,055 --> 05:37:31,724 ONE, WHICH WAS THE BLOOD, 8221 05:37:31,724 --> 05:37:34,226 METABOLISM AND SYSTEMIC 8222 05:37:34,226 --> 05:37:34,627 ENVIRONMENT. 8223 05:37:34,627 --> 05:37:37,062 IN THIS SESSION, SPEAKERS 8224 05:37:37,062 --> 05:37:38,631 EMPHASIZED THAT BECAUSE BRAIN 8225 05:37:38,631 --> 05:37:41,667 HEALTH AND BODY HEALTH ARE 8226 05:37:41,667 --> 05:37:42,902 INTRICATELY LINKED, IMPROVEMENTS 8227 05:37:42,902 --> 05:37:45,571 IN LIFESTYLE FACTORS ALSO MAY 8228 05:37:45,571 --> 05:37:47,339 BENEFITED COGNITION AS 8229 05:37:47,339 --> 05:37:48,774 INDIVIDUALS AGE. 8230 05:37:48,774 --> 05:37:50,209 HIGHLIGHTS FROM THIS SESSION 8231 05:37:50,209 --> 05:37:52,144 INCLUDED RESEARCH THAT SHOWED 8232 05:37:52,144 --> 05:37:54,046 LEVELS OF SEVERAL INFLAMMATORY 8233 05:37:54,046 --> 05:37:56,949 PROTEINS INCREASE IN THE BRAIN 8234 05:37:56,949 --> 05:37:58,817 WITH AGE AND THAT HIGHER 8235 05:37:58,817 --> 05:38:00,152 ESTROGEN LEVELS DURING PREGNANCY 8236 05:38:00,152 --> 05:38:02,688 CAN LEAD TO INCREASED BRAIN 8237 05:38:02,688 --> 05:38:05,191 FUNCTIONAL CONNECTIVITY. 8238 05:38:05,191 --> 05:38:06,859 SAY KEY TAKE AWAY FOR THIS 8239 05:38:06,859 --> 05:38:08,694 SESSION IS THAT FUTURE RESEARCH 8240 05:38:08,694 --> 05:38:10,763 INTO SPECIFIC MECHANISMS BY 8241 05:38:10,763 --> 05:38:12,965 WHICH PLASMA PROTEIN AND HORMONE 8242 05:38:12,965 --> 05:38:15,734 LEVELS AFFECT BRAIN FUNCTION MAY 8243 05:38:15,734 --> 05:38:18,137 HELP INFORM INDIVIDUALIZED 8244 05:38:18,137 --> 05:38:24,343 THERAPEUTIC INTERVENTIONS. 8245 05:38:24,343 --> 05:38:25,911 SESSION TWO WAS THE STRUCTURAL 8246 05:38:25,911 --> 05:38:27,079 AND SOCIAL ENVIRONMENT. 8247 05:38:27,079 --> 05:38:28,814 IN THIS SESSION, SPEAKERS 8248 05:38:28,814 --> 05:38:31,050 ADDRESSED THE COGNITIVE EFFECTS 8249 05:38:31,050 --> 05:38:34,620 OF SOCIODEMOGRAPHIC FACTORS, THE 8250 05:38:34,620 --> 05:38:36,055 BUILT ENVIRONMENT AND 8251 05:38:36,055 --> 05:38:37,289 INTERPERSONAL SOCIAL 8252 05:38:37,289 --> 05:38:39,024 DETERMINANTS OF HEALTH, ALL OF 8253 05:38:39,024 --> 05:38:40,226 WHICH MAY CONTRIBUTE TO 8254 05:38:40,226 --> 05:38:41,760 INDIVIDUAL DIFFERENCES ACROSS 8255 05:38:41,760 --> 05:38:44,296 THE LIFE COURSE. 8256 05:38:44,296 --> 05:38:46,165 THE STETION HIGHLIGHTED THE NEED 8257 05:38:46,165 --> 05:38:46,932 FOR -- THE SESSION HIGHLIGHTED 8258 05:38:46,932 --> 05:38:49,335 THE NEED FOR FURTHER RESEARCH TO 8259 05:38:49,335 --> 05:38:50,436 DISENTANGLE THE IMASKTS 8260 05:38:50,436 --> 05:38:51,403 FREQUENTLY INTERSECTING SOCIAL 8261 05:38:51,403 --> 05:38:54,373 AND EXPERIENTIAL FACTORS ON 8262 05:38:54,373 --> 05:38:56,342 INDIVIDUAL COGNITIVE HEALTH 8263 05:38:56,342 --> 05:38:57,876 OUTCOMES, SHOWING HOW STRESSORS 8264 05:38:57,876 --> 05:38:59,745 LIKE PERCEIVED DISCRIMINATION 8265 05:38:59,745 --> 05:39:03,115 AND LACK OF EQUITABLE ACCESS TO 8266 05:39:03,115 --> 05:39:06,385 EDUCATION CORRELATE WITH 8267 05:39:06,385 --> 05:39:07,119 INFLAMMATION IN THE BRAIN AS 8268 05:39:07,119 --> 05:39:10,889 WELL AS INCREASED DEPRESSIVE 8269 05:39:10,889 --> 05:39:12,224 SYMPTOMS. 8270 05:39:12,224 --> 05:39:14,393 AND WHILE RESILIENCE PATHWAYS 8271 05:39:14,393 --> 05:39:15,828 APPEAR TO BE PROTECTIVE OF 8272 05:39:15,828 --> 05:39:18,430 MEMORY FUNCTION IN CONTEXT TO 8273 05:39:18,430 --> 05:39:19,965 THESE STRESSORS. 8274 05:39:19,965 --> 05:39:22,167 KEY TAKE AWAYS WERE THAT 8275 05:39:22,167 --> 05:39:23,135 IMPROVING OUR UNDERSTANDING OF 8276 05:39:23,135 --> 05:39:26,105 THESE FACTORS CAN INFORM POLICY 8277 05:39:26,105 --> 05:39:29,608 AS WELL AS NEIGHBORHOOD LEVEL 8278 05:39:29,608 --> 05:39:29,942 INTERVENTIONS. 8279 05:39:29,942 --> 05:39:32,711 SESSION THREE WAS THE GENETIC 8280 05:39:32,711 --> 05:39:33,012 ENVIRONMENT. 8281 05:39:33,012 --> 05:39:35,080 THIS SESSION FOCUSED ON THE ROLE 8282 05:39:35,080 --> 05:39:37,416 OF SPECIFIC CHROMOSOMES, GENES, 8283 05:39:37,416 --> 05:39:39,485 AND PROTEINS IN SHAPING 8284 05:39:39,485 --> 05:39:44,290 COGNITIVE AGING AND DISEASE. 8285 05:39:44,290 --> 05:39:45,424 RESEARCH PRESENTED HIGHLIGHTED 8286 05:39:45,424 --> 05:39:47,259 CORRELATIONS BETWEEN COGNITIVE 8287 05:39:47,259 --> 05:39:48,761 DECLINE AND GENE EXPRESSION 8288 05:39:48,761 --> 05:39:51,263 THROUGHOUT NEURONAL CELLS AND ON 8289 05:39:51,263 --> 05:39:51,964 THE X CHROMOSOME. 8290 05:39:51,964 --> 05:39:54,500 THE KEY TAKE AWAY BEING THAT 8291 05:39:54,500 --> 05:39:56,769 FURTHER RESEARCH ON SEX AND GENE 8292 05:39:56,769 --> 05:39:57,970 INTERACTIONS MAY CONTRIBUTE TO 8293 05:39:57,970 --> 05:40:00,406 THE DEVELOPMENT OF TARGETED AND 8294 05:40:00,406 --> 05:40:01,407 PERSONALIZED INTERVENTIONS TO 8295 05:40:01,407 --> 05:40:07,212 IMPROVE COGNITIVE HEALTH. 8296 05:40:07,212 --> 05:40:09,281 SESSION FOUR WAS THE CIRCUIT 8297 05:40:09,281 --> 05:40:09,581 ENVIRONMENT. 8298 05:40:09,581 --> 05:40:12,151 THIS SESSION EXAMINED HOW GENE 8299 05:40:12,151 --> 05:40:13,118 EXPRESSION, CELLULAR ACTIVITIES 8300 05:40:13,118 --> 05:40:15,087 AND BRAIN MORPHOLOGY CAN AFFECT 8301 05:40:15,087 --> 05:40:18,057 LEARNING, MEMORY AND NAVIGATION. 8302 05:40:18,057 --> 05:40:20,893 RESEARCH PRESENTED SHOWED HOW 8303 05:40:20,893 --> 05:40:23,162 AGING RESULTS IN LOSS OF 8304 05:40:23,162 --> 05:40:25,364 SYNAPTIC DENSITY AND 8305 05:40:25,364 --> 05:40:28,334 INCONSISTENCY IN SPATIAL FIRING 8306 05:40:28,334 --> 05:40:29,034 PATTERNS. 8307 05:40:29,034 --> 05:40:32,171 AND THAT IN BOTH HUMAN AND 8308 05:40:32,171 --> 05:40:36,208 ANIMAL EXPERIMENTS, UPREGULATION 8309 05:40:36,208 --> 05:40:38,410 OF THE PER 1 GENE, HIGHER LEVELS 8310 05:40:38,410 --> 05:40:41,146 OF ESTROGENS, AND CONSISTENCY IN 8311 05:40:41,146 --> 05:40:42,581 NEURONAL FIRING CORRESPOND WITH 8312 05:40:42,581 --> 05:40:44,283 BETTER ABILITY TO LEARN AND 8313 05:40:44,283 --> 05:40:45,651 REMEMBER SPATIAL ENVIRONMENTS IN 8314 05:40:45,651 --> 05:40:49,121 YOUNG INDIVIDUALS. 8315 05:40:49,121 --> 05:40:51,123 THE KEY TAKE AWAY IS THAT 8316 05:40:51,123 --> 05:40:52,291 FURTHER STUDIES CAN HELP 8317 05:40:52,291 --> 05:40:53,659 IDENTIFY OTHER GENES, THEIR 8318 05:40:53,659 --> 05:40:54,927 MECHANISM OF ACTION, AND 8319 05:40:54,927 --> 05:40:56,028 POSSIBLE INTERVENTIONS TO 8320 05:40:56,028 --> 05:41:01,934 PROTECT AGAINST AGE-RELATED 8321 05:41:01,934 --> 05:41:02,167 DECLINE. 8322 05:41:02,167 --> 05:41:04,770 SESSION FIVE WAS COMORBIDITIES 8323 05:41:04,770 --> 05:41:06,538 AND THE SLEEP ENVIRONMENT, AND 8324 05:41:06,538 --> 05:41:07,973 THIS SESSION SPEAKERS EXPLORED 8325 05:41:07,973 --> 05:41:12,010 THE IMPORTANCE OF SLEEP, 8326 05:41:12,010 --> 05:41:13,946 CARDIOVASCULAR DISEASE AND 8327 05:41:13,946 --> 05:41:15,381 DEPRESSION AND RISK FOR 8328 05:41:15,381 --> 05:41:17,349 COGNITIVE DECLINE AND DEMENTIA, 8329 05:41:17,349 --> 05:41:19,218 HIGHLIGHTING THE CENTRALLY ROLE 8330 05:41:19,218 --> 05:41:20,886 THAT SLEEP PLAYS IN LEARNING AND 8331 05:41:20,886 --> 05:41:22,187 MEMORY BY HELPING CLEAR THE 8332 05:41:22,187 --> 05:41:24,056 BRAIN OF MISS FOLDED PROTEINS 8333 05:41:24,056 --> 05:41:26,892 AND OTHER DEBRIS THAT COULD LEAD 8334 05:41:26,892 --> 05:41:28,394 TO NEURODEGENERATION. 8335 05:41:28,394 --> 05:41:29,728 THE KEY TAKE AWAY FROM THIS 8336 05:41:29,728 --> 05:41:31,797 SESSION IS THAT FUTURE STUDIES 8337 05:41:31,797 --> 05:41:34,333 THAT PROBE HOW COMORBIDITIES AND 8338 05:41:34,333 --> 05:41:35,834 SLEEP AFFECT RISK FOR COGNITIVE 8339 05:41:35,834 --> 05:41:37,403 DECLINE NEED TO TAKE PLACE IN 8340 05:41:37,403 --> 05:41:43,175 EARLY AND MIDLIFE. 8341 05:41:43,175 --> 05:41:45,444 AND THE FINAL AND SIXTH SESSION, 8342 05:41:45,444 --> 05:41:47,379 STUDY DESIGN AND INTERVENTION 8343 05:41:47,379 --> 05:41:48,714 ENVIRONMENT, PRESENTERS DELVED 8344 05:41:48,714 --> 05:41:51,750 INTO NOVEL METHODS FOR DELAYING 8345 05:41:51,750 --> 05:41:53,051 COGNITIVE DECLINE AND REVIEWED 8346 05:41:53,051 --> 05:41:55,354 THE RESULTS FROM SEVERAL RECENT 8347 05:41:55,354 --> 05:41:56,789 INTERVENTION TRIALS, 8348 05:41:56,789 --> 05:41:57,656 HIGHLIGHTING THAT TREATMENT 8349 05:41:57,656 --> 05:41:59,291 RESPONSES WITHIN INTERVENTIONS 8350 05:41:59,291 --> 05:42:00,025 ARE COMPLEX. 8351 05:42:00,025 --> 05:42:01,493 I THINK WE'VE SEEN THAT 8352 05:42:01,493 --> 05:42:03,896 HIGHLIGHTED IN THE AD SUMMIT. 8353 05:42:03,896 --> 05:42:05,998 A KEY TAKE AWAY IS THAT THE USE 8354 05:42:05,998 --> 05:42:08,500 OF METHODOLOGICAL DESIGNS LIKE 8355 05:42:08,500 --> 05:42:10,903 DIGITAL TWINS AND OTHER AI BASED 8356 05:42:10,903 --> 05:42:12,771 METHODS MAY HELP RESEARCHERS 8357 05:42:12,771 --> 05:42:15,307 DESIGN MULTIFACTOR INTERVENTIONS 8358 05:42:15,307 --> 05:42:17,176 THAT TARGET INDIVIDUALS BASED ON 8359 05:42:17,176 --> 05:42:21,146 GENETIC AND LIFESTYLE RISK 8360 05:42:21,146 --> 05:42:21,780 FACTORS. 8361 05:42:21,780 --> 05:42:23,115 AGAIN, I THANK YOU FOR THE 8362 05:42:23,115 --> 05:42:24,516 OPPORTUNITY TO BE ABLE TO SHARE 8363 05:42:24,516 --> 05:42:26,285 SOME OF THE KEY TAKE AWAYS AND 8364 05:42:26,285 --> 05:42:28,253 HIGHLIGHTS FROM OUR COGNITIVE 8365 05:42:28,253 --> 05:42:29,087 AGING SUMMIT FOUR THAT TOOK 8366 05:42:29,087 --> 05:42:31,290 PLACE IN MARCH OF THIS IMREER, 8367 05:42:31,290 --> 05:42:32,858 AND AGAIN -- OF THIS YEAR, AND 8368 05:42:32,858 --> 05:42:34,593 AGAIN, I ENCOURAGE YOU TO VISIT 8369 05:42:34,593 --> 05:42:36,895 OUR WEBSITE WHICH YOU CAN SEE 8370 05:42:36,895 --> 05:42:38,530 TALKS FROM THE SESSIONS AND ALSO 8371 05:42:38,530 --> 05:42:41,266 SEE UPDATES ONCE THE SPECIAL 8372 05:42:41,266 --> 05:42:43,469 ISSUE IN NEUROBIOLOGY OF AGING 8373 05:42:43,469 --> 05:42:52,444 HAS BEEN RELEASED. 8374 05:42:52,444 --> 05:42:53,979 >> THANK YOU, ERIN. 8375 05:42:53,979 --> 05:42:57,616 WELL, AND FINALLY, I AM AT A 8376 05:42:57,616 --> 05:42:58,750 LOSS FOR WORDS. 8377 05:42:58,750 --> 05:43:00,219 THAT DOESN'T HAPPEN VERY OFTEN, 8378 05:43:00,219 --> 05:43:00,986 AS YOU KNOW. 8379 05:43:00,986 --> 05:43:03,956 BUT FROM ALL OF US AT THE NIA, 8380 05:43:03,956 --> 05:43:07,559 FROM ALL OF MY COLLEAGUES WHO 8381 05:43:07,559 --> 05:43:09,561 HAVE CONTRIBUTED AND MADE THE 8382 05:43:09,561 --> 05:43:11,196 SUMMIT POSSIBLE, NOT JUST THE 8383 05:43:11,196 --> 05:43:13,065 SUMMIT POSSIBLE, FOR ALL OF US 8384 05:43:13,065 --> 05:43:16,668 AT THE NIA, PARTICULARLY MY 8385 05:43:16,668 --> 05:43:17,769 COLLEAGUES WHO DEVELOPED THE 8386 05:43:17,769 --> 05:43:19,538 INITIATIVES THAT LED TO THE 8387 05:43:19,538 --> 05:43:22,808 PROGRAMS, THAT LED TO THE 8388 05:43:22,808 --> 05:43:24,209 PROGRESS YOU HEARD ABOUT IN THE 8389 05:43:24,209 --> 05:43:26,612 LAST THREE DAYS, AN ENORMOUS 8390 05:43:26,612 --> 05:43:29,448 GRATITUDE TO ALL OF YOU. 8391 05:43:29,448 --> 05:43:31,984 ALL OF THE SUMMIT SPEAKERS, 8392 05:43:31,984 --> 05:43:34,887 PANELISTS, CO-CHAIRS, WHO ARE 8393 05:43:34,887 --> 05:43:36,021 GOING TO CONTINUE TO WORK OVER 8394 05:43:36,021 --> 05:43:37,890 THE NEXT FEW WEEKS TO CONTINUE 8395 05:43:37,890 --> 05:43:41,260 TO REFINE THE GAPS AND 8396 05:43:41,260 --> 05:43:43,161 OPPORTUNITIES AND FINALIZE THE 8397 05:43:43,161 --> 05:43:45,597 PRODUCT FROM THIS SUMMIT THAT WE 8398 05:43:45,597 --> 05:43:49,067 WILL THEN TAKE AND TRANSLATE 8399 05:43:49,067 --> 05:43:51,603 INTO TACTICAL STEPS AND BUILD IT 8400 05:43:51,603 --> 05:43:53,238 AND REFRESH THE RESEARCH 8401 05:43:53,238 --> 05:43:56,508 FRAMEWORK FOR ADRD THAT WILL BE 8402 05:43:56,508 --> 05:43:59,478 POINTED TO THE CONTINUED 8403 05:43:59,478 --> 05:44:02,180 EVOLUTION OF PRECISION MEDICINE 8404 05:44:02,180 --> 05:44:04,816 RESEARCH ENTERPRISE WITH THE 8405 05:44:04,816 --> 05:44:06,919 PARTICIPANTS, PATIENTS AND THEIR 8406 05:44:06,919 --> 05:44:08,754 FAMILIES AND ITS EPICENTER. 8407 05:44:08,754 --> 05:44:12,057 A SPECIAL DEBT OF GRATITUDE TO 8408 05:44:12,057 --> 05:44:15,527 THE PARTICIPANTS IN THE PANEL, 8409 05:44:15,527 --> 05:44:17,195 PARTICIPANTS AS DIRECT PARTNERS 8410 05:44:17,195 --> 05:44:17,863 OF THE RESEARCH. 8411 05:44:17,863 --> 05:44:19,831 THAT FOR ME WAS THE SUMMIT OF 8412 05:44:19,831 --> 05:44:22,234 THE SUMMIT, IF I CAN PICK A 8413 05:44:22,234 --> 05:44:22,501 FAVORITE. 8414 05:44:22,501 --> 05:44:24,970 AND AGAIN, THANK YOU ALL. 8415 05:44:24,970 --> 05:44:27,072 SAFE TRAVEL HOME. 8416 05:44:27,072 --> 05:44:28,974 WE REST TONIGHT, BUT TOMORROW, 8417 05:44:28,974 --> 05:44:29,641 WE CONTINUE. 8418 05:44:29,641 --> 05:44:39,818 THANK YOU. 8419 05:44:45,090 --> 05:44:55,300 [3:32 P.M. EST] 8420 06:42:13,301 --> 06:42:13,935 RESISTENT MOUSE 8421 06:42:13,935 --> 06:42:16,805 AND START TO SEE INCREASE IN 8422 06:42:16,805 --> 06:42:19,875 MICE IN ALLERGEN ABSORPTION 8423 06:42:19,875 --> 06:42:22,077 NAÏVE NOT ALLERGIC MICE AND IS 8424 06:42:22,077 --> 06:42:23,478 STEADY STATE AND WHAT IS 8425 06:42:23,478 --> 06:42:25,747 INTERESTING IS IF YOU TAKE 8426 06:42:25,747 --> 06:42:27,783 SUSCEPTIBLE MICE HERE WITH SILO 8427 06:42:27,783 --> 06:42:30,252 STATIN AND WE HAVE IMPAIRED 8428 06:42:30,252 --> 06:42:31,953 FUNCTION AND SILO STATIN DIDN'T 8429 06:42:31,953 --> 06:42:33,889 DO MUCH AND IS CONSISTENT ADDING 8430 06:42:33,889 --> 06:42:36,258 UP TO THIS WORKING MODEL THAT 8431 06:42:36,258 --> 06:42:38,226 SENSITIZED TOLERANT AND 8432 06:42:38,226 --> 06:42:40,362 RESISTENT GROUP OVER HERE IN RED 8433 06:42:40,362 --> 06:42:43,065 HAD AN OVERACTIVE OR HIGHLY 8434 06:42:43,065 --> 06:42:45,534 ACTIVE D PEP 1 THAT IS CLEARING 8435 06:42:45,534 --> 06:42:48,336 ACTIVE LEUKO TRYINES BAD ACTORS 8436 06:42:48,336 --> 06:42:52,240 IN THE GUT REDUCING ABSORPTION 8437 06:42:52,240 --> 06:42:56,511 AND WHAT IS EXCITING IS LEUKO 8438 06:42:56,511 --> 06:42:57,279 TRYINES ARE POTENTIALLY PRESENT 8439 06:42:57,279 --> 06:43:02,050 NOT AT STEADY STATE AND ALLERGIC 8440 06:43:02,050 --> 06:43:03,251 REACTION AND SENSITIZATION AND 8441 06:43:03,251 --> 06:43:04,753 PHYSIOLOGY OF THE GUT AND 8442 06:43:04,753 --> 06:43:08,557 ALLERGENS GETTING ACROSS AND NEW 8443 06:43:08,557 --> 06:43:10,625 WAYS TO THINK ABOUT THESE. 8444 06:43:10,625 --> 06:43:12,928 AGAIN THOUGH THIS IS A FAIRLY 8445 06:43:12,928 --> 06:43:14,996 DRUGGED PATHWAY IN HUMANS AND 8446 06:43:14,996 --> 06:43:16,965 ALSO MEANT WE HAD A BUNCH OF 8447 06:43:16,965 --> 06:43:19,067 TOOLS AT DISPOSAL TO MESS WITH 8448 06:43:19,067 --> 06:43:21,136 THIS IN MICE AND SEE DO WE ALTAR 8449 06:43:21,136 --> 06:43:24,873 WHAT WE THINK WE ARE ALTARING? 8450 06:43:24,873 --> 06:43:26,608 ONE DRUG IS THIS WIDELY USED 8451 06:43:26,608 --> 06:43:29,444 DRUG IN PATIENTS WITH A-S MA AND 8452 06:43:29,444 --> 06:43:32,814 IT HITS ONE OF THE TWO RECEPTORS 8453 06:43:32,814 --> 06:43:36,184 OF THE LEUKO TRYINES AND TO OUR 8454 06:43:36,184 --> 06:43:39,387 DISMAY WHEN WE USE MONTI LEUKAS 8455 06:43:39,387 --> 06:43:40,956 WE DIDN'T CHANGE THE RESPONSE 8456 06:43:40,956 --> 06:43:43,725 WHATSOEVER TO ANAFILL AXIS THAT 8457 06:43:43,725 --> 06:43:45,927 IS TEMPERATURE DROP AND ANAFILL 8458 06:43:45,927 --> 06:43:48,864 AXIS SCORE AND WE ARE TAKING 8459 06:43:48,864 --> 06:43:51,299 SUSCEPTIBLE MICE WITH IMPAIRED D 8460 06:43:51,299 --> 06:43:54,302 PEP 1 AND HEIGHTENED LEUKO 8461 06:43:54,302 --> 06:43:56,938 TRYINES GIVING INHIBITOR DIDN'T 8462 06:43:56,938 --> 06:43:58,573 SEEM TO PROTECT AND SCRATCHING 8463 06:43:58,573 --> 06:44:00,142 HEADS ABOUT THIS FOR A WHILE AND 8464 06:44:00,142 --> 06:44:01,710 REALIZE WHAT WE ARE DOING IS 8465 06:44:01,710 --> 06:44:03,378 HITTING ONE OF THE TWO RECEPTORS 8466 06:44:03,378 --> 06:44:05,647 AND MAY HAVE REDUNDANCY HERE AND 8467 06:44:05,647 --> 06:44:08,216 WHAT WE THINK IS GOING ON AND WE 8468 06:44:08,216 --> 06:44:09,518 WENT UPSTREAM AND USED A 8469 06:44:09,518 --> 06:44:10,952 DIFFERENT DRUG THAT IS 8470 06:44:10,952 --> 06:44:14,389 CLINICALLY USED NOT WIDELY USED 8471 06:44:14,389 --> 06:44:17,659 ANYMORE AND WE COULD ACTUALLY 8472 06:44:17,659 --> 06:44:18,627 INHIBIT PRODUCTION OF THESE 8473 06:44:18,627 --> 06:44:20,162 WHICH IS KNOCK THE WHOLE THING 8474 06:44:20,162 --> 06:44:22,631 OUT AND DID THAT AND IT IS 8475 06:44:22,631 --> 06:44:23,999 REALLY EXCITING AND COMPLETELY 8476 06:44:23,999 --> 06:44:26,601 WIPED OUT RESPONSE AND NO 8477 06:44:26,601 --> 06:44:29,671 ANAFILL AXIS IN SUSCEPTIBLE MICE 8478 06:44:29,671 --> 06:44:32,741 AND EXCITING WE LOST ALLERGEN 8479 06:44:32,741 --> 06:44:36,511 ABSORPTION AND ARGUED PATHWAY 8480 06:44:36,511 --> 06:44:40,148 THAT IS REGULATING THE RESPONSE 8481 06:44:40,148 --> 06:44:43,451 AND SERUM UPTAKE AND THEREBY 8482 06:44:43,451 --> 06:44:46,421 TRIGGERING OF SUBMUCOSAL MASS 8483 06:44:46,421 --> 06:44:48,857 CELLS AND ANAFILL AXIS RESPONSE 8484 06:44:48,857 --> 06:44:50,659 AND EXCITING PROOF OF PRINCIPLE 8485 06:44:50,659 --> 06:44:53,094 TYPE OF EXPERIMENT IF YOU BYPASS 8486 06:44:53,094 --> 06:44:56,898 GUT AND GIVE PEANUT TO MICE AND 8487 06:44:56,898 --> 06:44:58,233 PRE-TREATED THEM WITH SDIELUTIN 8488 06:44:58,233 --> 06:45:01,469 NOW THEY RESPOND IT IS NOT JUST 8489 06:45:01,469 --> 06:45:04,573 AN INHIBITOR OF ANAFILL AXIS 8490 06:45:04,573 --> 06:45:06,441 RESPONSE AND WHAT IT IS REALLY 8491 06:45:06,441 --> 06:45:10,212 DOING IS REGULATING HOW MUCH 8492 06:45:10,212 --> 06:45:11,446 ALLERGEN GETS ACROSS TO MASS 8493 06:45:11,446 --> 06:45:13,081 CELLS AND IS EXCITING AND WANT 8494 06:45:13,081 --> 06:45:14,716 TO UNDERSTAND IS THIS TRUE IN 8495 06:45:14,716 --> 06:45:15,517 HUMANS? 8496 06:45:15,517 --> 06:45:18,620 I WILL LEAVE YOU WITH KIND OF 8497 06:45:18,620 --> 06:45:19,554 TANTALIZING LEADS AND ARE 8498 06:45:19,554 --> 06:45:21,523 WORKING ON THIS NOW AND WHERE WE 8499 06:45:21,523 --> 06:45:23,959 I THINK NEED TO GO AND THERE HAS 8500 06:45:23,959 --> 06:45:25,760 ACTUALLY BEEN DATA OUT THERE FOR 8501 06:45:25,760 --> 06:45:28,597 A LONG TIME AND KEPT SEEING 8502 06:45:28,597 --> 06:45:30,632 ALLERGEN ABSORPTION DIFFERENCES 8503 06:45:30,632 --> 06:45:32,634 IN MICE LOOKED BACK THIS SEEMS 8504 06:45:32,634 --> 06:45:34,703 WEIRD WHY DO YOU WANT ALLERGENS 8505 06:45:34,703 --> 06:45:37,572 IN TACT WHEN MEASURING IN SERUM 8506 06:45:37,572 --> 06:45:40,675 WE ARE MEASURING IN TACT 8507 06:45:40,675 --> 06:45:43,111 ALLERGENS NOT DIGESTING UP FOR 8508 06:45:43,111 --> 06:45:44,446 NUTRIENTS YOU ARE DOING SOME OF 8509 06:45:44,446 --> 06:45:47,649 THAT AND GETTING ATTACKED 8510 06:45:47,649 --> 06:45:49,351 ALLERGENS ACROSS AND MASS CELL 8511 06:45:49,351 --> 06:45:51,620 AND IGE HAS TO RECOGNIZE THAT 8512 06:45:51,620 --> 06:45:52,854 STRUCTURE AND IF YOU LOOK BACK 8513 06:45:52,854 --> 06:45:54,623 EVEN IN THE 20S AND 30S THAT 8514 06:45:54,623 --> 06:45:56,324 PEOPLE HAVE BEEN DESCRIBING THIS 8515 06:45:56,324 --> 06:45:58,326 PATHWAY IN HUMANS USING ALL 8516 06:45:58,326 --> 06:46:00,195 SORTS OF WEIRD THINGS IF YOU 8517 06:46:00,195 --> 06:46:02,497 WANT A FUN AND INTERESTING 8518 06:46:02,497 --> 06:46:03,898 BIZARRE READ I HIGHLY RECOMMEND 8519 06:46:03,898 --> 06:46:05,467 READING THIS ONE AND WHERE 8520 06:46:05,467 --> 06:46:07,535 AUTHORS THAT ACTUALLY HAVE A 8521 06:46:07,535 --> 06:46:08,637 STRIKING SIMILARITY TO PATIENTS 8522 06:46:08,637 --> 06:46:12,240 ALSO TESTED IN THE STUDY AND 8523 06:46:12,240 --> 06:46:16,211 INGESTED TISSUE FIBRINO GIN AND 8524 06:46:16,211 --> 06:46:17,646 CLOTTING FACTOR AND MEASURED 8525 06:46:17,646 --> 06:46:19,414 CLOTTING TIME AND SHOWED IT 8526 06:46:19,414 --> 06:46:20,548 CHANGES IN A SLIGHTLY 8527 06:46:20,548 --> 06:46:23,418 FRIGHTENING WAY AND YOU CAN DO 8528 06:46:23,418 --> 06:46:26,988 THIS WITH OVALBUMI AND WITH 8529 06:46:26,988 --> 06:46:29,391 PEANUT AND DONE ALL SORTS OF 8530 06:46:29,391 --> 06:46:31,159 THINGS AND ARGUES PATHWAY IS 8531 06:46:31,159 --> 06:46:32,861 OPERATIONAL IN HUMANS AS WELL 8532 06:46:32,861 --> 06:46:34,663 AND FUN TO SPECULATE AS TO WHY 8533 06:46:34,663 --> 06:46:36,197 AND HAVE THOUGHTS IF ANYBODY 8534 06:46:36,197 --> 06:46:37,699 WANTS TO TALK ABOUT IT AT THE 8535 06:46:37,699 --> 06:46:40,669 END AND WHAT IS EXCITING IS 8536 06:46:40,669 --> 06:46:42,203 TAKING D PEP 1 WE DESCRIBED IN 8537 06:46:42,203 --> 06:46:44,039 THE MICE AND LINE IT UP WITH 8538 06:46:44,039 --> 06:46:45,907 HUMANS AND ACTUALLY THE HUMANS 8539 06:46:45,907 --> 06:46:47,642 HAVE THE VERSION THAT MATCHES 8540 06:46:47,642 --> 06:46:49,277 VERY MUCH THE SENSITIVE GROUP 8541 06:46:49,277 --> 06:46:51,646 AND ACTUALLY IN MOST OF THE 8542 06:46:51,646 --> 06:46:53,248 STUDIES, MOST PATIENTS -- 8543 06:46:53,248 --> 06:46:54,616 ACTUALLY THESE ARE HEALTHY 8544 06:46:54,616 --> 06:46:58,086 VOLUNTEERS NO THE JUST ALLERGIC 8545 06:46:58,086 --> 06:47:00,388 PATIENTS ABSORB ALLERGENS AND 8546 06:47:00,388 --> 06:47:03,892 THIS IS NORMAL STEADY STATE AND 8547 06:47:03,892 --> 06:47:05,794 B6 MICE ARE WEIRD MICE HERE 8548 06:47:05,794 --> 06:47:07,729 POINT MUTATION RESULTING IN 8549 06:47:07,729 --> 06:47:09,564 CHANGE IN D PEP 1 ACTIVITY. 8550 06:47:09,564 --> 06:47:12,467 THERE IS ACTUALLY A PRETTY 8551 06:47:12,467 --> 06:47:13,902 STRIKING HOMOLOGY HERE. 8552 06:47:13,902 --> 06:47:15,603 THIS IS THE MODEL I WILL SUM UP 8553 06:47:15,603 --> 06:47:15,904 HERE. 8554 06:47:15,904 --> 06:47:17,605 I WOULD LOVE TO HAVE A 8555 06:47:17,605 --> 06:47:18,640 DISCUSSION AND QUESTIONS. 8556 06:47:18,640 --> 06:47:22,410 SO WE THINK WHAT IS HAPPENING IN 8557 06:47:22,410 --> 06:47:24,879 SENSITIZED TOLERANCE STATE IS 8558 06:47:24,879 --> 06:47:28,383 POTENTIALLY THERE IS A LOW LEVEL 8559 06:47:28,383 --> 06:47:30,618 OF LEUKO TRINES; RIGHT? 8560 06:47:30,618 --> 06:47:32,420 A LITTLE C AND A LITTLE D AND 8561 06:47:32,420 --> 06:47:35,657 NOT A LOT AND REGULATING HOW 8562 06:47:35,657 --> 06:47:38,126 MUCH ALEARTHINS GET ACROSS AND 8563 06:47:38,126 --> 06:47:41,663 HAVING IGE LOADED ON A MASS CELL 8564 06:47:41,663 --> 06:47:44,065 ALEARTHINS CAN'T GET ACROSS AND 8565 06:47:44,065 --> 06:47:45,600 TAKEN UP IN TACT AND IN TACT 8566 06:47:45,600 --> 06:47:47,669 PART OF THIS IS IMPORTANT AS A 8567 06:47:47,669 --> 06:47:50,338 WHOLE PEANUT AND PROTEIN 8568 06:47:50,338 --> 06:47:53,141 EPITOPES NEEDING TO BE 8569 06:47:53,141 --> 06:47:54,609 RECOGNIZED BY ANTIBODIES AND 8570 06:47:54,609 --> 06:47:56,678 WHAT HAPPENS IS THEY HAVE BEEN 8571 06:47:56,678 --> 06:47:59,013 SENSITIZED AND NOW HAVE A LOT 8572 06:47:59,013 --> 06:48:03,184 MORE ASIS ENNO LEUKO TRYINES 8573 06:48:03,184 --> 06:48:05,019 WHETHER D PEP 1 OR IN MICE AND 8574 06:48:05,019 --> 06:48:08,056 PART OF THE PATHWAY AND NOT JUST 8575 06:48:08,056 --> 06:48:11,192 D PEP 1 AND ALLERGENS GET ACROSS 8576 06:48:11,192 --> 06:48:12,727 AND MAGIC ARROW HERE AND 8577 06:48:12,727 --> 06:48:14,262 FIGURING OUT CELLULAR MECHANISM 8578 06:48:14,262 --> 06:48:16,431 FOR THIS DON'T THINK IT IS A 8579 06:48:16,431 --> 06:48:19,367 LEAKY GUT BUT ACTIVE PROCESS AND 8580 06:48:19,367 --> 06:48:23,371 NOW PEANUT GETS ACROSS AND 8581 06:48:23,371 --> 06:48:25,874 ALLERGEN GET AS CROSS 8582 06:48:25,874 --> 06:48:27,542 DEREGULATING MASS CELLS ENDING 8583 06:48:27,542 --> 06:48:30,245 UP WITH ANAPHYLACTIC RESPONSE 8584 06:48:30,245 --> 06:48:32,947 AND MEASURE PROCESS AND ARROW 8585 06:48:32,947 --> 06:48:34,315 MEASURING WHAT IS IN THE BLOOD 8586 06:48:34,315 --> 06:48:35,650 STREAM AND ONE OF THE MOST 8587 06:48:35,650 --> 06:48:36,851 EXCITING THINGS I HAVE BEEN ABLE 8588 06:48:36,851 --> 06:48:40,121 TO DO BY MOVING TO MORJ WESTERN 8589 06:48:40,121 --> 06:48:41,656 WHICH I'M EXCITED ABOUT IS PROOF 8590 06:48:41,656 --> 06:48:44,192 OF CONCEPT TRIAL THAT IS 8591 06:48:44,192 --> 06:48:45,326 STARTING HOPEFULLY IN THE FALL 8592 06:48:45,326 --> 06:48:47,562 AND DO A PROOF OF CONCEPT TRIAL 8593 06:48:47,562 --> 06:48:51,032 IN HUMANS ASKING CAN WE MODULATE 8594 06:48:51,032 --> 06:48:53,368 ALLERGEN ABSORPTION IN SOMEONE 8595 06:48:53,368 --> 06:48:56,304 WHO MAYBE HAS A FOOD ALEARTHY 8596 06:48:56,304 --> 06:48:59,674 AND WON'T GET ALLERGEN AND DO 8597 06:48:59,674 --> 06:49:02,210 REAL DEAL TEST CAN WE BLOCK 8598 06:49:02,210 --> 06:49:04,279 ANAFILL AXIS UPTAKE INTO THE 8599 06:49:04,279 --> 06:49:05,914 BLOOD STREAM. PEOPLE HAVE BEEN 8600 06:49:05,914 --> 06:49:07,615 DOING THIS IN HEALTHY VOLUNTEERS 8601 06:49:07,615 --> 06:49:09,517 AND IS A TIME COURSE FROM A 8602 06:49:09,517 --> 06:49:12,153 REALLY ELEGANT STUDY LOOKING AT 8603 06:49:12,153 --> 06:49:14,489 ABSORPTION OF PEANUT ALLERGENS 8604 06:49:14,489 --> 06:49:16,224 INTO THE BLOOD STREAM IN 8605 06:49:16,224 --> 06:49:18,993 PATIENTS YOU CAN SEE HOW FAST IT 8606 06:49:18,993 --> 06:49:21,129 HAPPENS THIS IS 10 MINUTES HERE 8607 06:49:21,129 --> 06:49:24,499 AND TWO DAYS OUT HERE AND MOST 8608 06:49:24,499 --> 06:49:28,102 PEOPLE DO THIS AND CAN THEY 8609 06:49:28,102 --> 06:49:29,704 ABSORB ALLERGENS INTO THE BLOOD 8610 06:49:29,704 --> 06:49:33,575 STREAM AND DO THIS WITH OR 8611 06:49:33,575 --> 06:49:35,410 WITHOUT TREATMENT AND GIVES 8612 06:49:35,410 --> 06:49:38,112 ANGLE FOR THERAPEUTICALLY 8613 06:49:38,112 --> 06:49:39,547 INTERVENING AND PREVENTING 8614 06:49:39,547 --> 06:49:41,182 ANAFILL AXIS AND WITH THAT I 8615 06:49:41,182 --> 06:49:43,585 WANT TO STOP AND THANK AMAZING 8616 06:49:43,585 --> 06:49:45,954 GROUP THAT IS LAB PARTY STILL AT 8617 06:49:45,954 --> 06:49:47,822 YALE AND NORTHWESTERN AND IS THE 8618 06:49:47,822 --> 06:49:49,757 GROUP THAT GETS TOGETHER EVERY 8619 06:49:49,757 --> 06:49:52,760 SUMMER IN CHICAGO IN BOTH SITES 8620 06:49:52,760 --> 06:49:54,996 AND WORK TOGETHER AS A TEAM AND 8621 06:49:54,996 --> 06:49:57,031 LAURA AND ELYSE IS AT YALE AND 8622 06:49:57,031 --> 06:50:00,034 LAURA IS INCREDIBLE DEDICATED 8623 06:50:00,034 --> 06:50:04,305 PHD WILLING TO TAKE ON THAT FOR 8624 06:50:04,305 --> 06:50:06,741 GENETIC TEAM AND STUDIES AND 8625 06:50:06,741 --> 06:50:09,944 DOING STUDIES AT TWO DIFFERENT 8626 06:50:09,944 --> 06:50:10,578 INSTITUTIONS ALL HIGHLIGHTED 8627 06:50:10,578 --> 06:50:13,948 HERE IN RED AND ARE AN 8628 06:50:13,948 --> 06:50:15,450 INCREDIBLE GROUP AND WE HAVE HAD 8629 06:50:15,450 --> 06:50:17,819 HELP FROM A NUMBER OF DIFFERENT 8630 06:50:17,819 --> 06:50:21,289 LABS AND WYLAN LAB AMAZING DOING 8631 06:50:21,289 --> 06:50:22,624 BEAUTIFUL WORK AT YALE LOOKING 8632 06:50:22,624 --> 06:50:24,859 AT GUT IMMUNE SYSTEM TELLING US 8633 06:50:24,859 --> 06:50:27,562 A LOT AND HELPED WITH A BIT OF 8634 06:50:27,562 --> 06:50:29,631 STUDIES AND POINTING OUT THIS IS 8635 06:50:29,631 --> 06:50:31,566 HUSBAND ADAM MOVING TO 8636 06:50:31,566 --> 06:50:32,934 NORTHWESTERN AND TOLD TRAINEES 8637 06:50:32,934 --> 06:50:34,602 TODAY WE ARE ABLE TO HAVE A 8638 06:50:34,602 --> 06:50:37,338 JOINT LAB SUPER FUN AND NEW 8639 06:50:37,338 --> 06:50:38,640 SPACE WE MOVED INTO NOW MORE 8640 06:50:38,640 --> 06:50:41,276 THAN A YEAR AGO AND IS A JOY TO 8641 06:50:41,276 --> 06:50:42,944 REALLY BE ABLE TO DO THIS WORK 8642 06:50:42,944 --> 06:50:44,312 WITH HIM. 8643 06:50:44,312 --> 06:50:46,147 WE HAVE A NUMBER OF GREAT 8644 06:50:46,147 --> 06:50:47,315 FUNDERS THAT REALLY HAVE STUCK 8645 06:50:47,315 --> 06:50:49,517 WITH US WHILE DOING -- YOU KNOW, 8646 06:50:49,517 --> 06:50:51,819 WE WERE REALLY WRONG ABOUT IGA 8647 06:50:51,819 --> 06:50:53,454 AT BEGINNING I THINK AND HAD TO 8648 06:50:53,454 --> 06:50:55,390 COME BACK TO BASELINE SAYING 8649 06:50:55,390 --> 06:50:57,158 WHAT ELSE COULD IT BE AND STUCK 8650 06:50:57,158 --> 06:50:59,127 WITH US THROUGH ALL OF THAT AND 8651 06:50:59,127 --> 06:51:01,296 INTERESTED IN THE NEW CENTER 8652 06:51:01,296 --> 06:51:04,265 STARTING AT NORTHWESTERN Q.R. 8653 06:51:04,265 --> 06:51:05,667 CODE CAN LEARN ABOUT WHO IS IN 8654 06:51:05,667 --> 06:51:07,969 IT AND WHAT WE ARE DOG AND 8655 06:51:07,969 --> 06:51:09,504 SHOUTOUT TO [INDISCERNIBLE] AT 8656 06:51:09,504 --> 06:51:12,373 YALE AND CLASSMATE OF LAURA'S 8657 06:51:12,373 --> 06:51:15,176 FROM DIFFERENT VANTAGE POINT 8658 06:51:15,176 --> 06:51:18,146 STUMBLED ON SAME EXACT PATHWAY 8659 06:51:18,146 --> 06:51:19,714 ALLERGEN ABSORPTION FROM 8660 06:51:19,714 --> 06:51:21,816 DIFFERENT VANTAGE POINTS 8661 06:51:21,816 --> 06:51:23,518 REGULATING ASPECTS OF ALLERGY 8662 06:51:23,518 --> 06:51:25,353 AND COSIGNED PAPERS TOGETHER AND 8663 06:51:25,353 --> 06:51:28,222 FUN AND WONDERFUL SYNERGISTIC 8664 06:51:28,222 --> 06:51:29,357 COLLABORATION BETWEEN OUR LAB 8665 06:51:29,357 --> 06:51:30,558 AND THEIR LAB AND WITH THAT 8666 06:51:30,558 --> 06:51:41,069 WOULD LOVE TO TAKE QUESTIONS. 8667 06:51:50,378 --> 06:51:53,114 >> GREAT TALK. IT IS REALLY 8668 06:51:53,114 --> 06:51:55,783 STRIKING HOW QUICKLY ALL OF THIS 8669 06:51:55,783 --> 06:51:57,552 HAPPENS AS YOU POINTED OUT A 8670 06:51:57,552 --> 06:51:58,019 COUPLE TIMES. 8671 06:51:58,019 --> 06:51:58,453 >> YEAH. 8672 06:51:58,453 --> 06:52:00,054 >> HAS THAT MADE YOU WONDER 8673 06:52:00,054 --> 06:52:02,123 WHETHER EXPOSURE THAT HAPPENS IS 8674 06:52:02,123 --> 06:52:07,595 HAPPENING IN THE ORAL MUCOSA OR 8675 06:52:07,595 --> 06:52:09,597 ES AFTER GAUS BEFORE IT GETS TO 8676 06:52:09,597 --> 06:52:12,934 GUT AND LOOKING AT IT IN SALIVA 8677 06:52:12,934 --> 06:52:13,601 OR TISSUES THERE. 8678 06:52:13,601 --> 06:52:15,136 >> IT IS ABSOLUTELY A PERFECT 8679 06:52:15,136 --> 06:52:17,171 QUESTION AND IF YOU DON'T THINK 8680 06:52:17,171 --> 06:52:19,874 ABOUT ALLERGY PEOPLE WITH FOOD 8681 06:52:19,874 --> 06:52:22,076 ALLERGY CAN RESPOND SOMETIMES 8682 06:52:22,076 --> 06:52:23,945 WITHIN MINUTES BEING EXPOSED TO 8683 06:52:23,945 --> 06:52:26,080 AN ALLERGEN AND WHAT THAT HAS 8684 06:52:26,080 --> 06:52:28,650 ARGUED IN THE FIELD; RIGHT? 8685 06:52:28,650 --> 06:52:31,019 NOT JUST OUR LAB THINKING ABOUT 8686 06:52:31,019 --> 06:52:33,821 THIS AND MAYBE ALLERGENS ARE 8687 06:52:33,821 --> 06:52:35,356 GETTING ABSORBED THROUGH ORAL 8688 06:52:35,356 --> 06:52:37,291 MUCOSA AND HOW IT IS GETTING IN 8689 06:52:37,291 --> 06:52:38,593 AND ONE THING I WILL SAY IS MOST 8690 06:52:38,593 --> 06:52:42,530 OF THE MOUSE STUDIES WE BYPASS 8691 06:52:42,530 --> 06:52:44,332 MOUSE AND LIKE PEANUTS AND IF 8692 06:52:44,332 --> 06:52:46,200 YOU FEED THEM THEY ARE HAPPY AND 8693 06:52:46,200 --> 06:52:48,703 WILL EAT THEM AND STUDIES AND 8694 06:52:48,703 --> 06:52:51,172 TIMING AND EVERYTHING TO DO 8695 06:52:51,172 --> 06:52:52,707 ORALLY GAF AUJ IT AND NOT GOING 8696 06:52:52,707 --> 06:52:54,008 THROUGH MOUTH BUT GETTING 8697 06:52:54,008 --> 06:52:55,943 THROUGH AND ADMINISTERED TO THE 8698 06:52:55,943 --> 06:52:57,412 STOMACH AND THEN INTO THE GUT. 8699 06:52:57,412 --> 06:53:00,648 WE CAN REALLY FIND THE ALLERGEN 8700 06:53:00,648 --> 06:53:02,617 IN THE BLOOD WITHIN 30 MINUTES 8701 06:53:02,617 --> 06:53:05,119 TO AN HOUR AND IS DETECTING IT 8702 06:53:05,119 --> 06:53:06,921 IN THE SERUM AND WHATEVER IS 8703 06:53:06,921 --> 06:53:08,222 HAPPENING IS HAPPENING QUICKLY 8704 06:53:08,222 --> 06:53:10,591 NO MATTER WHERE IT IS IN MUCOSA. 8705 06:53:10,591 --> 06:53:13,261 >> MAY BE STOMACH TOO AND 8706 06:53:13,261 --> 06:53:14,896 EVERYONE THINKS OF GUT AS 8707 06:53:14,896 --> 06:53:16,097 DOWNSTREAM OF THAT. 8708 06:53:16,097 --> 06:53:17,665 >> ABSOLUTELY. GOOD THOUGHT. 8709 06:53:17,665 --> 06:53:18,566 >> REALLY INTERESTING. 8710 06:53:18,566 --> 06:53:21,269 >> GREAT TALK. I HAD A COUPLE 8711 06:53:21,269 --> 06:53:22,837 QUESTIONS AND FIRST ONE IS 8712 06:53:22,837 --> 06:53:24,238 SENSITIZED TOLERANT GROUP AND 8713 06:53:24,238 --> 06:53:26,607 LOOKING AT SYSTEMIC AND GUT IGA 8714 06:53:26,607 --> 06:53:28,676 AND DID YOU LOOK AT OTHER 8715 06:53:28,676 --> 06:53:31,379 SYSTEMIC ANTIBODIES LIKE 8716 06:53:31,379 --> 06:53:32,346 CIRCULATING IGA. 8717 06:53:32,346 --> 06:53:32,980 >> WE DID. 8718 06:53:32,980 --> 06:53:35,183 >> YOU MENTIONED IGG AND ANY 8719 06:53:35,183 --> 06:53:37,585 PATTERN TO BE ABSORBING AND 8720 06:53:37,585 --> 06:53:37,885 PREVENTING. 8721 06:53:37,885 --> 06:53:40,021 >> NO. MOST OF THE WORK TO DATE 8722 06:53:40,021 --> 06:53:43,458 IS DONE USING BLOOD SAMPLES IS 8723 06:53:43,458 --> 06:53:46,594 EASIER AND LESS SMELLY THAN 8724 06:53:46,594 --> 06:53:50,565 STOOL AND MOST LOOKED AT IGA AND 8725 06:53:50,565 --> 06:53:52,500 IT MATCHED THE SAME AND WAS SAME 8726 06:53:52,500 --> 06:53:53,935 AS STOOL AND IF ANYTHING IS 8727 06:53:53,935 --> 06:53:55,470 HIGHER IN ALLERGICS. 8728 06:53:55,470 --> 06:53:57,438 >> THAT IS INTERESTING AND 8729 06:53:57,438 --> 06:53:59,340 SECOND QUESTION QUICKLY IF NOT 8730 06:53:59,340 --> 06:54:01,209 COMING THROUGH ESOPHAGUS OR 8731 06:54:01,209 --> 06:54:03,845 STOMACH IS A BIG BARRIER IN THE 8732 06:54:03,845 --> 06:54:05,847 GUT AND MUCUS AND TIGHT 8733 06:54:05,847 --> 06:54:06,147 JUNCTIONS. 8734 06:54:06,147 --> 06:54:06,614 >> YEAH. 8735 06:54:06,614 --> 06:54:10,618 >> IMMUNE RESPONSES CAN EFFECT 8736 06:54:10,618 --> 06:54:11,652 DIFFERENT JUNCTIONS. 8737 06:54:11,652 --> 06:54:12,987 >> YEAH. 8738 06:54:12,987 --> 06:54:18,626 >> PORES OR BIGGER PORES AND 8739 06:54:18,626 --> 06:54:21,796 EPITHELIAL CELLS AND LOOKING AT 8740 06:54:21,796 --> 06:54:23,664 THOSE AND IF CHANGED WITH REGARD 8741 06:54:23,664 --> 06:54:25,299 TO LEUKO TRYINES. 8742 06:54:25,299 --> 06:54:29,670 >> MY BIAS IS PARACELLULAR 8743 06:54:29,670 --> 06:54:33,541 ALLERGEN ABSORPTION OR PASSAGE 8744 06:54:33,541 --> 06:54:36,277 OR YOU WANT TO CALL IT IS NOT 8745 06:54:36,277 --> 06:54:38,613 MOST COMMON WAY TO GET IT ACROSS 8746 06:54:38,613 --> 06:54:41,315 AND LEAKY GUT LOSS OF JUNCTIONS 8747 06:54:41,315 --> 06:54:42,617 BETWEEN EPITHILIUM AND IS DATA 8748 06:54:42,617 --> 06:54:44,685 TO SUPPORT THAT CERTAINLY. 8749 06:54:44,685 --> 06:54:46,621 WHEN WE IMAGE WHAT WE SEE IS 8750 06:54:46,621 --> 06:54:49,490 LOTS -- IF YOU FLUORESCENTLY TAG 8751 06:54:49,490 --> 06:54:51,359 AN ALLERGEN LIKE OVA WE ARE 8752 06:54:51,359 --> 06:54:53,227 USING YOU CAN FIND IT ACTUALLY 8753 06:54:53,227 --> 06:54:55,696 TRANCE CELLULARLY BEING 8754 06:54:55,696 --> 06:54:56,664 TRANSPORTED THROUGH GUT 8755 06:54:56,664 --> 06:54:57,799 EPITHILIUM AND IN PARTICULAR 8756 06:54:57,799 --> 06:54:59,233 POPULATION IN THE GUT THAT IS 8757 06:54:59,233 --> 06:55:03,137 GOOD AT TAKING UP LARGE POCKETS 8758 06:55:03,137 --> 06:55:05,773 OF -- OF NOT JUST ALLERGENS BUT 8759 06:55:05,773 --> 06:55:07,708 THINGS IN THE GUT AND GOES 8760 06:55:07,708 --> 06:55:09,510 THROUGH CELL BODY AND TRANCE 8761 06:55:09,510 --> 06:55:12,113 CELLULAR TO THE OTHER SIDE AND 8762 06:55:12,113 --> 06:55:14,615 THINK THAT IT IS HOW IT IS 8763 06:55:14,615 --> 06:55:16,751 PROTECTED AND IN TACT AND NOT 8764 06:55:16,751 --> 06:55:20,555 ONES TO DESCRIBE THIS WORK FROM 8765 06:55:20,555 --> 06:55:21,823 RON NEWBURY. 8766 06:55:21,823 --> 06:55:22,557 >> GABBA CELLS. 8767 06:55:22,557 --> 06:55:24,692 >> I THINK THAT IS WHERE THIS IS 8768 06:55:24,692 --> 06:55:24,926 GOING. 8769 06:55:24,926 --> 06:55:25,259 >> UH-HUH. 8770 06:55:25,259 --> 06:55:28,930 >> THIS IS ACTUALLY REGULATED BY 8771 06:55:28,930 --> 06:55:31,399 PATHWAY WE DESCRIBED AND HOW 8772 06:55:31,399 --> 06:55:34,001 MUCH ALLERGEN TRANSPORT 8773 06:55:34,001 --> 06:55:35,503 HAPPENING AT THAT LEVEL AND 8774 06:55:35,503 --> 06:55:36,604 DON'T UNDERSTAND HOW. 8775 06:55:36,604 --> 06:55:40,641 >> DON'T THINK THEY EFFECT GABBA 8776 06:55:40,641 --> 06:55:42,210 CELL NUMBERS FOR EXAMPLE. 8777 06:55:42,210 --> 06:55:42,610 >> DON'T KNOW. 8778 06:55:42,610 --> 06:55:43,411 >> OKAY. 8779 06:55:43,411 --> 06:55:45,079 >> THAT IS SOME WHERE THERE IS 8780 06:55:45,079 --> 06:55:46,747 CONNECTION THERE WHERE DIRECT OR 8781 06:55:46,747 --> 06:55:47,648 INDIRECT AND DON'T KNOW. 8782 06:55:47,648 --> 06:55:50,251 >> THANK YOU VERY MUCH. 8783 06:55:50,251 --> 06:55:50,585 INTERESTING. 8784 06:55:50,585 --> 06:55:52,753 >> HEY. GREAT TALK. 8785 06:55:52,753 --> 06:55:53,221 >> [INDISCERNIBLE]. 8786 06:55:53,221 --> 06:55:57,525 >> YES. SO I HAVE TWO QUESTIONS 8787 06:55:57,525 --> 06:55:58,926 AND FIRST IS DO YOU THINK 8788 06:55:58,926 --> 06:56:00,461 DIFFERENCE IN ABSORPTION PLAYS 8789 06:56:00,461 --> 06:56:02,964 ALSO A ROLE AND NOT ONLY IN 8790 06:56:02,964 --> 06:56:05,666 CHALLENGE BUT DURING 8791 06:56:05,666 --> 06:56:08,169 SENSITIZATION BREAKDOWN? 8792 06:56:08,169 --> 06:56:10,605 SECOND QUESTION IS OTHER 8793 06:56:10,605 --> 06:56:13,140 ALLERGEN ABSORPTION CHANGES 8794 06:56:13,140 --> 06:56:13,608 THROUGHOUT LIFESPAN. 8795 06:56:13,608 --> 06:56:15,009 >> GREAT QUESTIONS AND QUESTIONS 8796 06:56:15,009 --> 06:56:16,177 WE WOULD LOVE TO ANSWER. 8797 06:56:16,177 --> 06:56:18,613 IF I HAD TO SPECULATE AND WE 8798 06:56:18,613 --> 06:56:20,014 HAVE NOT DONE ANYTHING YET AND 8799 06:56:20,014 --> 06:56:23,651 WILL START TO DO SOME OF THIS 8800 06:56:23,651 --> 06:56:24,418 NOW. 8801 06:56:24,418 --> 06:56:25,953 IF PATHWAY IS OPERATIONAL FOR 8802 06:56:25,953 --> 06:56:27,822 ORAL TOLERANCE AND BET IT IS 8803 06:56:27,822 --> 06:56:29,590 IMPORTANT FOR ORAL TOLERANCE AND 8804 06:56:29,590 --> 06:56:31,259 DON'T KNOW HOW AND DON'T KNOW IF 8805 06:56:31,259 --> 06:56:33,027 THAT IS EVEN TRUE AND IS MY 8806 06:56:33,027 --> 06:56:35,663 GUESS AND WHY I THINK THIS IS A 8807 06:56:35,663 --> 06:56:36,831 HOMEO STATIC MECHANISM AND IF 8808 06:56:36,831 --> 06:56:38,599 YOU MESS WITH IT DOES IT CHANGE 8809 06:56:38,599 --> 06:56:40,668 AND WE ARE TRYING TO FIGURE IT 8810 06:56:40,668 --> 06:56:42,603 OUT RIGHT NOW AND HAVEN'T -- WE 8811 06:56:42,603 --> 06:56:46,374 DON'T HAVE ANY DATA YET JUST 8812 06:56:46,374 --> 06:56:46,674 HYPOTHESES. 8813 06:56:46,674 --> 06:56:49,610 IDEA OF IT CHANGING OVER A LIFE 8814 06:56:49,610 --> 06:56:50,978 OR ESPECIALLY AT YOUNG AGE 8815 06:56:50,978 --> 06:56:54,782 VERSUS IS A GREAT THOUGHT AND WE 8816 06:56:54,782 --> 06:56:56,250 HAVE LIKE 8 MILLION EXPERIMENTS 8817 06:56:56,250 --> 06:56:58,219 WE ARE TRYING TO DO AND TRYING 8818 06:56:58,219 --> 06:57:00,388 TO DO IT WITH PEDIATRIC SAMPLES 8819 06:57:00,388 --> 06:57:02,723 TO SEE IF WE CAN LOOK AT THIS. 8820 06:57:02,723 --> 06:57:04,492 WE HAVEN'T -- WE ARE STARTING 8821 06:57:04,492 --> 06:57:06,027 PROOF OF CONCEPT TRIAL I TOLD 8822 06:57:06,027 --> 06:57:08,429 YOU ABOUT WE WILL DO WITH ADULTS 8823 06:57:08,429 --> 06:57:09,697 AND FOR SAFETY REASONS AND OTHER 8824 06:57:09,697 --> 06:57:13,301 THINGS WE HAVE TO START WITH 8825 06:57:13,301 --> 06:57:15,670 ADU 8826 06:57:15,670 --> 06:57:15,903 ADULTS. 8827 06:57:15,903 --> 06:57:17,271 >> I WOULD LOVE TO DO IT AND 8828 06:57:17,271 --> 06:57:19,907 DON'T KNOW TO DO A HUMAN TRIAL 8829 06:57:19,907 --> 06:57:21,809 TO TEST THAT YET AND CAN TRY TO 8830 06:57:21,809 --> 06:57:26,614 DO IN MICE AND GETS HARDER 8831 06:57:26,614 --> 06:57:32,353 TRYING TO GAF AUJ THINGS. 8832 06:57:32,353 --> 06:57:37,858 >> SOMETHING NOT RELATED TO THIS 8833 06:57:37,858 --> 06:57:40,161 STUDYING INFECTION AND BREAKDOWN 8834 06:57:40,161 --> 06:57:41,996 TOLERANCE AND FOUND MICE WITH 8835 06:57:41,996 --> 06:57:44,765 INFLUENZA AND GIVE OVA YOU HAVE 8836 06:57:44,765 --> 06:57:49,303 RESPONSES IN LYMPH NODE AND 8837 06:57:49,303 --> 06:57:50,071 CONTRIBUTES TO BREAKDOWN 8838 06:57:50,071 --> 06:57:50,371 TOLERANCE. 8839 06:57:50,371 --> 06:57:50,638 >> YEAH. 8840 06:57:50,638 --> 06:57:52,974 >> QUESTION IS ANTIGEN ORALLY. 8841 06:57:52,974 --> 06:57:53,374 >> YEAH. 8842 06:57:53,374 --> 06:57:55,176 >> IN LYMPH NODE. 8843 06:57:55,176 --> 06:57:58,612 >> I BET WITH THIS AND HAPPY TO 8844 06:57:58,612 --> 06:58:03,184 SHARE PROTOCOL AND OVA ALIZA 8845 06:58:03,184 --> 06:58:05,653 FROM BLOOD IS FINICKY AND IF YOU 8846 06:58:05,653 --> 06:58:07,688 WANT TO TRY THAT IS MY BET HOW 8847 06:58:07,688 --> 06:58:08,656 IT IS GETTING THERE. 8848 06:58:08,656 --> 06:58:09,957 >> THANK YOU. 8849 06:58:09,957 --> 06:58:11,292 >> WONDERFUL, STEPHANIE. 8850 06:58:11,292 --> 06:58:12,326 >> GREAT TO SEE YOU. 8851 06:58:12,326 --> 06:58:13,995 >> GREAT TO SEE YOU. 8852 06:58:13,995 --> 06:58:15,329 >> SORRY I DIDN'T TALK ABOUT 8853 06:58:15,329 --> 06:58:15,730 [INDISCERNIBLE]. 8854 06:58:15,730 --> 06:58:18,499 >> THIS IS BETTER THAN THAT. 8855 06:58:18,499 --> 06:58:20,634 I HAVE A QUESTION IF YOU LOOKED 8856 06:58:20,634 --> 06:58:22,403 AT D PEP 1 VARIANCE IN YOUR 8857 06:58:22,403 --> 06:58:23,504 POPULATION AND PREDICTION IS 8858 06:58:23,504 --> 06:58:25,873 LEVEL OF BIOCHEMICAL ACTIVITY 8859 06:58:25,873 --> 06:58:29,677 MIGHT CORRELATE TO HOW SEVERE 8860 06:58:29,677 --> 06:58:31,312 ALLERGEN OR ALLERGIC RESPONSE 8861 06:58:31,312 --> 06:58:31,579 MIGHT BE. 8862 06:58:31,579 --> 06:58:33,447 HUGE QUESTION THAT WE HAVE BEEN 8863 06:58:33,447 --> 06:58:37,018 TRYING TO TACKLE AND FAILED. 8864 06:58:37,018 --> 06:58:39,186 GWAS STUDIES NOT PULLING THEM 8865 06:58:39,186 --> 06:58:41,489 OUT D PEP 1 ITSELF AND DOESN'T 8866 06:58:41,489 --> 06:58:43,791 HAVE TO BE IT AND COULD BE 8867 06:58:43,791 --> 06:58:45,860 ANYTHING ALONG THE PATHWAY AND 8868 06:58:45,860 --> 06:58:48,295 SCOURING GWAS DATA BASE AND 8869 06:58:48,295 --> 06:58:50,197 PROBLEM FOR US IS WHERE WOULD WE 8870 06:58:50,197 --> 06:58:52,533 -- WE WOULD PREDICT TO SEE 8871 06:58:52,533 --> 06:58:53,367 BIGGEST DIFFERENCE BETWEEN 8872 06:58:53,367 --> 06:58:56,270 PATIENTS WHO HAVE IGE AND PASS 8873 06:58:56,270 --> 06:58:57,872 ORAL FOOD CHALLENGE VERSUS THOSE 8874 06:58:57,872 --> 06:59:00,908 THAT HAVE IGE AND FAIL AT ORAL 8875 06:59:00,908 --> 06:59:02,510 FOOD CHALLENGE AND PROBLEM NOT 8876 06:59:02,510 --> 06:59:04,612 HEALTHY VERSUS ALLERGIC 8877 06:59:04,612 --> 06:59:06,847 POPULATION WHICH IS WHERE GWAS 8878 06:59:06,847 --> 06:59:08,416 DATA IS AND SECOND PROBLEM TO 8879 06:59:08,416 --> 06:59:10,618 THAT IS IF YOU PASS ORAL FOOD 8880 06:59:10,618 --> 06:59:13,320 CHALLENGE IF SENSITIZED YOU ARE 8881 06:59:13,320 --> 06:59:15,656 -- YOU ARE NOT FOOD ALLERGIC AND 8882 06:59:15,656 --> 06:59:17,324 TRYING TO GET RIGHT DATA BASE OR 8883 06:59:17,324 --> 06:59:19,960 SAMPLES TO DO A PROOF OF CONCEPT 8884 06:59:19,960 --> 06:59:21,996 TRIAL THERE AS WELL AND IS A 8885 06:59:21,996 --> 06:59:23,597 LITTLE HARD AND THINK WE MIGHT 8886 06:59:23,597 --> 06:59:24,565 HAVE IDENTIFIED A GROUP TO DO 8887 06:59:24,565 --> 06:59:26,901 THIS AND HAVE TO -- IT WILL TAKE 8888 06:59:26,901 --> 06:59:27,435 A LITTLE WHILE. 8889 06:59:27,435 --> 06:59:29,303 >> VERY EXCITING. THANKS. 8890 06:59:29,303 --> 06:59:31,138 >> IF YOU THINK ABOUT THE 8891 06:59:31,138 --> 06:59:35,409 STUDIES LIKE NOW THE IDEA IS WE 8892 06:59:35,409 --> 06:59:37,344 SHOULD GIVE FOOD OR THIS TYPE OF 8893 06:59:37,344 --> 06:59:38,412 FOOD TO CHILDREN. 8894 06:59:38,412 --> 06:59:38,913 >> YEAH. 8895 06:59:38,913 --> 06:59:40,514 >> SO LIKE TO SENSITIZE THEM AND 8896 06:59:40,514 --> 06:59:42,183 NOW YOU ARE SAYING THERE IS 8897 06:59:42,183 --> 06:59:44,018 SOMETHING THAT ALLOWS THE FOOD 8898 06:59:44,018 --> 06:59:46,620 PASSAGE AND IS REGULATED ABOUT I 8899 06:59:46,620 --> 06:59:50,591 THIS MOLECULE. 8900 06:59:50,591 --> 06:59:53,994 HOW COME ONES WHICH HAVE THIS OR 8901 06:59:53,994 --> 06:59:57,865 B6 OR ONES WHICH ALLOW FOOD OR 8902 06:59:57,865 --> 07:00:01,068 ABT R- ANTIGEN PASSAGE AND 8903 07:00:01,068 --> 07:00:02,603 DEVELOPING ALLERGY REACTIONS 8904 07:00:02,603 --> 07:00:05,272 THAT ANYTHING POTENTIALLY GOING 8905 07:00:05,272 --> 07:00:06,140 THROUGH INTESTINE AND OTHER SIDE 8906 07:00:06,140 --> 07:00:09,643 HOW IS IT POSSIBLE WE CAN 8907 07:00:09,643 --> 07:00:10,778 DESENSITIZE BY FEEDING. 8908 07:00:10,778 --> 07:00:12,680 >> RIGHT. YOU HAVE MULTIPLE 8909 07:00:12,680 --> 07:00:14,315 QUESTIONS IMBEDDED IN THAT. 8910 07:00:14,315 --> 07:00:14,882 >> I KNOW. 8911 07:00:14,882 --> 07:00:17,017 >> LEAP TRIAL AND ORAL TOLERANCE 8912 07:00:17,017 --> 07:00:19,153 AND WHAT I WOULD CALL REAL ORAL 8913 07:00:19,153 --> 07:00:21,122 TOLERANCE THAT I THINK IS THE 8914 07:00:21,122 --> 07:00:23,257 BASIS OF TRIALS SHOWING EARLY 8915 07:00:23,257 --> 07:00:24,325 EXPOSURE BEING IMPORTANT WHAT 8916 07:00:24,325 --> 07:00:26,627 YOU ARE DOING IS INDUCING T 8917 07:00:26,627 --> 07:00:29,296 REGULARS AND NOT INDUCING IGE 8918 07:00:29,296 --> 07:00:31,265 AND NEVER GETTING TO SENSITIZED 8919 07:00:31,265 --> 07:00:33,334 PHASE AND THINK THAT IS BECAUSE 8920 07:00:33,334 --> 07:00:34,602 THE -- THE QUOTE ON QUOTE 8921 07:00:34,602 --> 07:00:36,637 NATURAL RESPONSE IN THE GUT IS 8922 07:00:36,637 --> 07:00:38,539 TO TOLERATE WHATEVER IS COMING 8923 07:00:38,539 --> 07:00:39,173 IN. 8924 07:00:39,173 --> 07:00:40,007 RIGHT? 8925 07:00:40,007 --> 07:00:40,274 >> YEAH. 8926 07:00:40,274 --> 07:00:42,910 >> BUT THEN HOW CAN YOU LIKE IF 8927 07:00:42,910 --> 07:00:45,079 YOU HAVE OVA PASSING THROUGH, 8928 07:00:45,079 --> 07:00:47,648 HOW DO YOU DEVELOP ALSO AN 8929 07:00:47,648 --> 07:00:49,984 ALLERGIC REACTION TO OVA BUT 8930 07:00:49,984 --> 07:00:52,186 DEVELOP RESPONSE, IG RESPONSES 8931 07:00:52,186 --> 07:00:56,290 AGAINST PEANUT WHICH GOES 8932 07:00:56,290 --> 07:00:56,724 THROUGH. 8933 07:00:56,724 --> 07:00:58,559 >> I WOULD ARGUE THEY WILL BE 8934 07:00:58,559 --> 07:01:00,861 IDENTICAL IF YOU MAKE IGE 8935 07:01:00,861 --> 07:01:02,096 RESPONSE AND PUT ALL THEM 8936 07:01:02,096 --> 07:01:03,731 THROUGH YOU HAVE ALLERGIC 8937 07:01:03,731 --> 07:01:06,300 REACTION TO EITHER IN GROUP THAT 8938 07:01:06,300 --> 07:01:07,268 PASSAGES THEM AND COMPLICATION 8939 07:01:07,268 --> 07:01:09,603 HERE IS I DON'T -- WE HAVE TO BE 8940 07:01:09,603 --> 07:01:11,205 CAREFUL IN THINKING ABOUT WHERAL 8941 07:01:11,205 --> 07:01:14,141 EARTH JI AND WE ARE MEASURING IN 8942 07:01:14,141 --> 07:01:16,377 BLOOD AND NICE SURROGATE READ 8943 07:01:16,377 --> 07:01:18,612 OUT GOTTEN ACROSS GUT AND DON'T 8944 07:01:18,612 --> 07:01:20,881 THINK ALLERGEN IN THE BLOOD IS 8945 07:01:20,881 --> 07:01:22,183 RELEVANT SITE FOR TOLERANCE AND 8946 07:01:22,183 --> 07:01:23,951 IS A READ OUT FOR US AND WHERE 8947 07:01:23,951 --> 07:01:27,521 ALL OF THE ACTION IS, IS IN THE 8948 07:01:27,521 --> 07:01:32,359 GUT ITSELF AND SURROGATE FOR 8949 07:01:32,359 --> 07:01:34,528 ALLEN TO GET ACROSS AND BAE NEEJ 8950 07:01:34,528 --> 07:01:36,197 IN THE GUT ITSELF THOUGH IS THAT 8951 07:01:36,197 --> 07:01:39,266 KIND OF -- WE CAN TALK MORE AT 8952 07:01:39,266 --> 07:01:39,700 DINNER. 8953 07:01:39,700 --> 07:01:43,504 >> REALLY INTERESTING TALK. 8954 07:01:43,504 --> 07:01:44,638 I HAVE A QUESTION ABOUT 8955 07:01:44,638 --> 07:01:46,173 SOMETHING YOU MENTIONED IN 8956 07:01:46,173 --> 07:01:47,274 BEGINNING OF TALK THAT IS 8957 07:01:47,274 --> 07:01:53,280 QUESTION OF WHAT MAKES ALLERGEN 8958 07:01:53,280 --> 07:01:55,916 AN ALLERGEN AND WRITTEN ABOUT IT 8959 07:01:55,916 --> 07:01:57,084 AND IN PARTICULAR SOMETHING THAT 8960 07:01:57,084 --> 07:01:59,119 STRUCK ME WHEN RESEARCHING THEM 8961 07:01:59,119 --> 07:02:00,955 IS LOTS ARE STORAGE PROTEINS IN 8962 07:02:00,955 --> 07:02:04,592 TET PRO MERS OR HEXO MERS AND 8963 07:02:04,592 --> 07:02:06,961 MORE STABLE FORMATIONS GETTING 8964 07:02:06,961 --> 07:02:08,562 DIGESTED LESS IN THE STOMACH AND 8965 07:02:08,562 --> 07:02:11,565 ABLE TO BE MORE IN INTACT FORM 8966 07:02:11,565 --> 07:02:14,301 WHEN POTENTIALLY CROSS A 8967 07:02:14,301 --> 07:02:14,568 BARRIER. 8968 07:02:14,568 --> 07:02:14,868 >> WHY HE. 8969 07:02:14,868 --> 07:02:16,971 >> HAVE PEOPLE COMPARED 8970 07:02:16,971 --> 07:02:20,507 DIFFERENT PROTEINS, PROTEINS 8971 07:02:20,507 --> 07:02:22,910 NONALLERGENS FOR WHAT PROPORTION 8972 07:02:22,910 --> 07:02:25,512 OF THE PROTEIN MAKES IT THROUGH 8973 07:02:25,512 --> 07:02:27,181 FOR EXAMPLE INTO THE 8974 07:02:27,181 --> 07:02:27,514 BLOODSTREAM? 8975 07:02:27,514 --> 07:02:28,916 >> WE CAN HAND WAVE A LOT ABOUT 8976 07:02:28,916 --> 07:02:31,051 THIS AND YOU NAILED A COUPLE OF 8977 07:02:31,051 --> 07:02:33,454 THEM ALREADY THAT IS PERFECT AND 8978 07:02:33,454 --> 07:02:34,922 ALLERGENS ARE SEED STORAGE 8979 07:02:34,922 --> 07:02:36,557 PROTEINS AND YOU ARE RIGHT AND 8980 07:02:36,557 --> 07:02:38,025 THEY ARE MORE STABLE AND THOUGHT 8981 07:02:38,025 --> 07:02:40,127 IS THEY ARE SMALL AND STABLE AND 8982 07:02:40,127 --> 07:02:42,763 MEANS THEY CAN PASS THROUGH 8983 07:02:42,763 --> 07:02:44,965 ACIDIC ENVIRONMENT OF STOMACH 8984 07:02:44,965 --> 07:02:46,667 AND STILL IN TACT THAT IS 8985 07:02:46,667 --> 07:02:48,736 IMPORTANT FOR TRIGGERING 8986 07:02:48,736 --> 07:02:49,903 RESPONSE AND PEOPLE HAVE LOOKED 8987 07:02:49,903 --> 07:02:52,139 AND ARGUED THAT YES THESE ARE 8988 07:02:52,139 --> 07:02:55,743 MORE LIKELY TO MAKE IT INTO THE 8989 07:02:55,743 --> 07:02:56,310 INTESTINE. 8990 07:02:56,310 --> 07:02:58,612 I DON'T KNOW OF ANYBODY WHO HAS 8991 07:02:58,612 --> 07:02:59,647 ARGUED FOR -- MOST PEOPLE DON'T 8992 07:02:59,647 --> 07:03:00,848 LOOK IN THE BLOOD. 8993 07:03:00,848 --> 07:03:02,583 IT IS A LITTLE PAIN TO DO AND I 8994 07:03:02,583 --> 07:03:04,251 CAN -- I DON'T -- IF YOU ASKED 8995 07:03:04,251 --> 07:03:08,255 ME A COUPLE YEARS AGO WOULD I 8996 07:03:08,255 --> 07:03:09,223 ANTICIPATE SEEING IN TACT 8997 07:03:09,223 --> 07:03:11,258 ALLERGENS IN THE BLOOD I WOULD 8998 07:03:11,258 --> 07:03:13,527 SAY NO AND DESPITE LITERATURE ON 8999 07:03:13,527 --> 07:03:15,496 HUMANS FOR THIS IN 80 YEARS AND 9000 07:03:15,496 --> 07:03:16,997 NOT SOMETHING WE THINK ABOUT AND 9001 07:03:16,997 --> 07:03:19,733 THEY ARE MOSTLY BROKEN UP IN THE 9002 07:03:19,733 --> 07:03:20,567 GUT; RIGHT? 9003 07:03:20,567 --> 07:03:22,369 ANSWER TO THAT LAST PART IS NO 9004 07:03:22,369 --> 07:03:23,570 AND SOMETHING WE SHOULD THINK 9005 07:03:23,570 --> 07:03:26,240 ABOUT IN TERMS WHAT MAKES 9006 07:03:26,240 --> 07:03:28,275 ALEARTH JEN ALEARTH JEN AND 9007 07:03:28,275 --> 07:03:29,209 AGREE WITH YOU. 9008 07:03:29,209 --> 07:03:30,678 >> RELATEBLY I HAVE A FOLLOW-UP 9009 07:03:30,678 --> 07:03:32,413 QUESTION AND WHEN LOOKING FOR 9010 07:03:32,413 --> 07:03:34,615 OVA IN THE BLOOD YOU USE 9011 07:03:34,615 --> 07:03:36,583 PRESUMABLY ANTIBODY AGAINST OVA. 9012 07:03:36,583 --> 07:03:38,018 >> WHY HE. 9013 07:03:38,018 --> 07:03:39,920 >> IT RECOGNIZES IN TACT. 9014 07:03:39,920 --> 07:03:40,187 >> YES. 9015 07:03:40,187 --> 07:03:43,023 >> YOU DON'T NECESSARILY KNOW 9016 07:03:43,023 --> 07:03:47,928 IFFA OVA FRAGMENTS ARE IN THE 9017 07:03:47,928 --> 07:03:48,162 BLOOD. 9018 07:03:48,162 --> 07:03:48,862 >> THAT IS RIGHT. 9019 07:03:48,862 --> 07:03:50,864 >> IT WOULD BE INTERESTING FOR A 9020 07:03:50,864 --> 07:03:52,766 COMPLICATED EXPERIENCE TO SEE IF 9021 07:03:52,766 --> 07:03:55,436 ACTUALLY IT IS A DIFFERENCE IN 9022 07:03:55,436 --> 07:03:59,039 ABSORPTION OR NOT ABSORPTION AND 9023 07:03:59,039 --> 07:04:00,774 DIFFERENCE IN IN TACT VERSUS NOT 9024 07:04:00,774 --> 07:04:02,209 IN TACT AND FRAGMENTED. 9025 07:04:02,209 --> 07:04:04,445 >> WE THOUGHT ABOUT THIS BY 9026 07:04:04,445 --> 07:04:06,447 NONINTACT DO YOU MEAN AMINO 9027 07:04:06,447 --> 07:04:08,215 ACIDS OR FRAGMENTS? 9028 07:04:08,215 --> 07:04:09,316 >> I GUESS BOTH. 9029 07:04:09,316 --> 07:04:12,219 >> YEAH. AMINO ACIDS I THINK 9030 07:04:12,219 --> 07:04:15,255 ARE VERY CLEARLY REGULATED FOR 9031 07:04:15,255 --> 07:04:16,924 NUTRIENT REASONS IN A DIFFERENT 9032 07:04:16,924 --> 07:04:18,592 WAY AND DON'T THINK AND THINK WE 9033 07:04:18,592 --> 07:04:28,669 ARE