1 00:00:07,741 --> 00:00:08,809 >> ALL RIGHT. LADIES AND 2 00:00:08,809 --> 00:00:09,977 GENTLEMEN, I WOULD LIKE TO 3 00:00:09,977 --> 00:00:12,679 WELCOME YOU TO THE BREAKOUT 4 00:00:12,679 --> 00:00:16,083 SESSION ON EXPANDING DRUG 5 00:00:16,083 --> 00:00:16,450 INDICATIONS. 6 00:00:16,450 --> 00:00:18,252 MY NAME IS [INDISCERNIBLE]. I'M 7 00:00:18,252 --> 00:00:24,491 ONE OF THE INTRAMURAL 8 00:00:24,491 --> 00:00:25,292 INVESTIGA 9 00:00:25,292 --> 00:00:30,264 INVESTIGATORS IN NIAD AND ALSO A 10 00:00:30,264 --> 00:00:31,832 CO-ORGANIZER AND MEMBER OF 11 00:00:31,832 --> 00:00:35,002 STEERING COMMITTEE FOR THIS 12 00:00:35,002 --> 00:00:41,575 MEETING SO SOME -- I WILL A 13 00:00:41,575 --> 00:00:43,343 LITTLE INTRODUCE THE SESSION AND 14 00:00:43,343 --> 00:00:45,946 WILL HAVE SIX WONDERFUL SPAESHGS 15 00:00:45,946 --> 00:00:47,614 TO TALK ABOUT THEIR EXPERIENCE 16 00:00:47,614 --> 00:00:49,049 IN THIS ARENA. 17 00:00:49,049 --> 00:00:51,852 AFTER THAT WE WILL HAVE Q & A 18 00:00:51,852 --> 00:00:52,185 SESSION. 19 00:00:52,185 --> 00:00:56,023 I HOPE THAT MANY OF YOU ALREADY 20 00:00:56,023 --> 00:00:57,457 PARTICIPATED IN THE PREVIOUS 21 00:00:57,457 --> 00:00:58,759 SPLIT-OUT SESSIONS. 22 00:00:58,759 --> 00:01:02,696 YOU KNOW THAT YOU CAN POST 23 00:01:02,696 --> 00:01:07,868 QUESTIONS USING THE QUESTION 24 00:01:07,868 --> 00:01:10,003 PANEL ON THE RIGHT SIDE. 25 00:01:10,003 --> 00:01:15,008 DRUGS ACHIEVED ALREADY GREATER 26 00:01:15,008 --> 00:01:16,543 SUCCESS FOR SECOND INDICATION 27 00:01:16,543 --> 00:01:18,345 COMPARED TO ORIGINAL INDICATION 28 00:01:18,345 --> 00:01:20,681 AND PERHAPS THE MOST LUSTROUS 29 00:01:20,681 --> 00:01:26,553 EXAMPLE OF THIS IS GOP1 AGONISTS 30 00:01:26,553 --> 00:01:28,221 ANTIDIABETIC DRUGS BEING 31 00:01:28,221 --> 00:01:29,756 CURRENTLY REPURPOSED FOR 32 00:01:29,756 --> 00:01:32,292 TREATMENT OF OBESITY AND 33 00:01:32,292 --> 00:01:35,462 NEVERTHELESS AS PATH TOWARDS 34 00:01:35,462 --> 00:01:37,097 TREATING NEW DISEASES 35 00:01:37,097 --> 00:01:39,700 REPURPOSING SEEMS TO BE MUCH 36 00:01:39,700 --> 00:01:41,868 MORE ADVANTAGEOUS TO ACADEMIC 37 00:01:41,868 --> 00:01:43,737 INVESTIGATORS AND IN PUBLIC 38 00:01:43,737 --> 00:01:47,074 COMPARED TO PEOPLE IN 39 00:01:47,074 --> 00:01:47,674 PHARMACEUTICAL INDUSTRY AND 40 00:01:47,674 --> 00:01:49,609 [INDISCERNIBLE] FROM N CAPS WILL 41 00:01:49,609 --> 00:01:51,044 EXPLAIN MANY REASONS THIS MIGHT 42 00:01:51,044 --> 00:01:52,179 BE THE CASE. 43 00:01:52,179 --> 00:01:56,483 WE WILL THEN HERE A FEW SUCCESS 44 00:01:56,483 --> 00:01:57,884 STORIES FACILITATED BY THE 45 00:01:57,884 --> 00:02:00,387 ORPHAN DRUG ACT EFFECTIVE 46 00:02:00,387 --> 00:02:01,722 LEGISLATIVE SOLUTION TO PART OF 47 00:02:01,722 --> 00:02:02,255 THIS PROBLEM. 48 00:02:02,255 --> 00:02:05,592 FOR THOSE THAT ARE WORKING ON 49 00:02:05,592 --> 00:02:07,594 CHRONIC UNTREATABLE DISEASES 50 00:02:07,594 --> 00:02:09,629 EFFECTING LARGER PROPORTION OF 51 00:02:09,629 --> 00:02:11,732 POPULATION THAN ONE COVERED BY 52 00:02:11,732 --> 00:02:15,869 OR FAN DRUG ACT, I WANT TO 53 00:02:15,869 --> 00:02:21,842 HIGHLIGHT THAT LACK OF ACCESS TO 54 00:02:21,842 --> 00:02:24,378 THERAPEUTIC AGENTS LIMIT ABILITY 55 00:02:24,378 --> 00:02:27,748 TO FULFILL NIH MISSION. 56 00:02:27,748 --> 00:02:30,150 SAYING LACK OF ACCESS I SAY 57 00:02:30,150 --> 00:02:32,652 THREE MAJOR CATEGORIES OF DRUGS 58 00:02:32,652 --> 00:02:35,522 ONE IS DRUGS ARE FDA APPROVED 59 00:02:35,522 --> 00:02:37,457 THAT ARE PROHIBITIVELY EXPENSIVE 60 00:02:37,457 --> 00:02:40,027 AND NONE CAN REALLY GO AND BUY 61 00:02:40,027 --> 00:02:43,764 THEM FOR PROOF OF PRINCIPLE 62 00:02:43,764 --> 00:02:53,206 CLINICAL TRIAL. 63 00:02:53,206 --> 00:02:55,042 REASONABLE SAFETY PROFILE THAT 64 00:02:55,042 --> 00:02:58,412 DIDN'T HAVE SUFFICIENT EFFICACY 65 00:02:58,412 --> 00:03:01,281 FOR PRIMARY INDICATION. 66 00:03:01,281 --> 00:03:04,051 THEORETICALLY DRUGS MIGHT BE 67 00:03:04,051 --> 00:03:06,686 RESEQUENCED IN PRACTICAL SENSE 68 00:03:06,686 --> 00:03:08,555 THEY ARE UNUSABLE. 69 00:03:08,555 --> 00:03:10,691 WE CAN'T CROSS-REFERENCE INDS 70 00:03:10,691 --> 00:03:11,858 THAT ARE SUPPORTED INFORMATION 71 00:03:11,858 --> 00:03:16,630 THAT IS NOT IN PUBLIC DOMAIN. 72 00:03:16,630 --> 00:03:19,933 LAST CATEGORY OF DRUGS ARE IN 73 00:03:19,933 --> 00:03:21,835 DEVELOPMENT FOR PRIMARY 74 00:03:21,835 --> 00:03:22,335 INDICATION. 75 00:03:22,335 --> 00:03:24,638 SOMETIMES DRUG COMPANY MAY NOT 76 00:03:24,638 --> 00:03:29,676 BE WILLING TO ENGAGE IN 77 00:03:29,676 --> 00:03:32,813 DEVELOPING SAME DRUG FOR 78 00:03:32,813 --> 00:03:34,948 SECONDARY INDICATION THAT IS 79 00:03:34,948 --> 00:03:37,717 SOMETIMES BASED ON 80 00:03:37,717 --> 00:03:39,920 UNSUBSTANTIATED FEAR THAT 81 00:03:39,920 --> 00:03:41,254 SOMEHOW SECONDARY INDICATION MAY 82 00:03:41,254 --> 00:03:43,090 CHALLENGE OR PREVENT PRIMARY 83 00:03:43,090 --> 00:03:46,593 INDICATION TO BE SUCCESSFUL. 84 00:03:46,593 --> 00:03:51,164 THIS FEAR IS NOT SUBSTANTIATED. 85 00:03:51,164 --> 00:03:56,703 SO, I MENTIONED NIH MISSION DR. 86 00:03:56,703 --> 00:04:00,273 BARR CONTINUE OELI NEW NIH 87 00:04:00,273 --> 00:04:01,675 DIRECTOR MENTIONED AS WELL 88 00:04:01,675 --> 00:04:03,510 MISSION TO SEEK FUNDAMENTAL 89 00:04:03,510 --> 00:04:05,045 KNOWLEDGE ABOUT NATURE AND 90 00:04:05,045 --> 00:04:07,714 BEHAVIOR OF LIVING SYSTEMS TO 91 00:04:07,714 --> 00:04:09,683 APPLY KNOWLEDGE TO ENHANCE 92 00:04:09,683 --> 00:04:13,887 HEALTH AND LENGTHEN LIFE AND 93 00:04:13,887 --> 00:04:15,522 REDUCE ILLNESS AND DISABILITY. 94 00:04:15,522 --> 00:04:19,259 WE CAN DO IT EFFECTIVELY IN 95 00:04:19,259 --> 00:04:22,496 ANIMAL MODELS AND IN VITRO 96 00:04:22,496 --> 00:04:24,564 STUDIES AND DO IT BY 97 00:04:24,564 --> 00:04:26,867 ESTABLISHING CORRELATION BETWEEN 98 00:04:26,867 --> 00:04:28,401 BIOMARKERS REFLECTING DISEASE 99 00:04:28,401 --> 00:04:32,472 PROCESS AND CLINICAL OUTCOMES 100 00:04:32,472 --> 00:04:33,974 FOR EXAMPLE OF DISEASE 101 00:04:33,974 --> 00:04:34,608 PROGRESSION. 102 00:04:34,608 --> 00:04:37,811 HOWEVER, IN ORDER TO DO FINAL 103 00:04:37,811 --> 00:04:39,012 STEP IN KNOWLEDGE ACQUISITION 104 00:04:39,012 --> 00:04:43,483 THAT IS IN STEP OF VALIDATION WE 105 00:04:43,483 --> 00:04:47,654 NEED ACCESS TO DRUGS BECAUSE 106 00:04:47,654 --> 00:04:49,790 ONLY WAY THAT YOU CAN VALIDATE 107 00:04:49,790 --> 00:04:53,460 KNOWLEDGE IS IN INTERVENTIONAL 108 00:04:53,460 --> 00:04:56,863 CLINICAL TRIAL TAKING DRUG 109 00:04:56,863 --> 00:04:58,398 INHIBITING PROPOSED DISEASE 110 00:04:58,398 --> 00:05:01,401 MECHANISM AND SHOWING THAT IF IT 111 00:05:01,401 --> 00:05:03,036 INHIBITS DISEASE MECHANISM IT 112 00:05:03,036 --> 00:05:07,440 ALSO INHIBITS DISEASE 113 00:05:07,440 --> 00:05:10,010 PROGRESSION AND LAST STEP IS 114 00:05:10,010 --> 00:05:13,013 MOST IMPORTANT IN YURN ANY TO 115 00:05:13,013 --> 00:05:20,554 TRANSLATING DRUGS TO HUMAN 116 00:05:20,554 --> 00:05:26,459 HEA 117 00:05:26,459 --> 00:05:27,093 HEALTH. 118 00:05:27,093 --> 00:05:30,964 INTRAMURAL RESEARCH PROGRAM IS 119 00:05:30,964 --> 00:05:34,000 UNIQUELY AMENABLE TO THIS LAST 120 00:05:34,000 --> 00:05:36,269 STEP IN KNOWLEDGE VALIDATION AND 121 00:05:36,269 --> 00:05:39,639 THANKS TO NIH CLINICAL CENTER 122 00:05:39,639 --> 00:05:42,576 THESE ARE DEEPLY PHENOTYPING 123 00:05:42,576 --> 00:05:46,546 DISEASES DEVELOPING BIOMARKERS 124 00:05:46,546 --> 00:05:48,582 WITH CLINICAL VALUE AND 125 00:05:48,582 --> 00:05:51,885 PREDICTIVE MODELS USING TOOLS IN 126 00:05:51,885 --> 00:05:54,020 PROOF OF PRINCIPLE CLINICAL 127 00:05:54,020 --> 00:05:56,289 TRIALS MAKING THEM ECONOMICAL 128 00:05:56,289 --> 00:06:00,560 AND ASSURING THAT THE KNOWLEDGE 129 00:06:00,560 --> 00:06:03,997 IS GAINED WHETHER TRIAL IS 130 00:06:03,997 --> 00:06:05,665 POSITIVE OR NEGATIVE. 131 00:06:05,665 --> 00:06:08,501 INDEED, WE LIVE IN A TIME WHEN 132 00:06:08,501 --> 00:06:12,572 INCREASING PREVALENCE OF CHRONIC 133 00:06:12,572 --> 00:06:23,116 DISEASES THREATENS VIABILITIES 134 00:06:23,583 --> 00:06:25,452 AND AREA I WORK THAT IS 135 00:06:25,452 --> 00:06:27,721 MARGINALLY THUS FAR AND LIKELY 136 00:06:27,721 --> 00:06:30,423 THAT EFFECTIVE TREATMENTS OF 137 00:06:30,423 --> 00:06:31,224 DISEASES WILL REQUIRE 138 00:06:31,224 --> 00:06:33,293 DEVELOPMENT OF THERAPEUTIC 139 00:06:33,293 --> 00:06:35,295 COMBINATIONS SIMULTANEOUSLY 140 00:06:35,295 --> 00:06:38,531 TARGETING MULTIPLE DISEASE 141 00:06:38,531 --> 00:06:39,666 MECHANISMS THAT REPRESENTS 142 00:06:39,666 --> 00:06:41,368 CHALLENGE BEYOND EVERYTHING THAT 143 00:06:41,368 --> 00:06:45,905 I MENTIONED THUS FAR THAT WE ARE 144 00:06:45,905 --> 00:06:49,209 HAPPY TO HAVE DOCTORS TO ADDRESS 145 00:06:49,209 --> 00:06:51,544 THIS PROBLEM AND UNDOUBTEDLY 146 00:06:51,544 --> 00:06:54,247 EXPANDING ACCESS TO EXISTING 147 00:06:54,247 --> 00:06:56,116 DRUGS FOR PROOF OF PRINCIPLE 148 00:06:56,116 --> 00:06:58,184 CLINICAL TRIALS HAS POTENTIAL TO 149 00:06:58,184 --> 00:07:00,020 BENEFIT STAKEHOLDERS AND HOPE 150 00:07:00,020 --> 00:07:02,956 THIS SESSION WILL TRANSFORM 151 00:07:02,956 --> 00:07:08,561 VISION TO SEE WIN/WIN SOLUTIONS 152 00:07:08,561 --> 00:07:09,029 GOING FORWARD. 153 00:07:09,029 --> 00:07:10,697 WITH THAT I WILL THANK YOU FOR 154 00:07:10,697 --> 00:07:11,398 BEING HERE. 155 00:07:11,398 --> 00:07:19,272 I WILL GIVE THE SPEAKER TO DR. 156 00:07:19,272 --> 00:07:19,639 COLIS. 157 00:07:19,639 --> 00:07:22,075 >> THANK YOU. THAT WAS A GREAT 158 00:07:22,075 --> 00:07:25,111 INTRODUCTION TO THE SESSION. 159 00:07:25,111 --> 00:07:29,049 I'M CHRISTINE AND I'M EXTRAMURAL 160 00:07:29,049 --> 00:07:35,355 PROGRAM DIRECTOR THAT I HEAD UP 161 00:07:35,355 --> 00:07:37,757 AN OFFICE CALLED OFFICE OF -- 162 00:07:37,757 --> 00:07:40,794 HERE AT THE NIH. 163 00:07:40,794 --> 00:07:42,562 I WILL TELL YOU ABOUT TWO 164 00:07:42,562 --> 00:07:45,198 DIFFERENT SORT OF SCENARIOS THAT 165 00:07:45,198 --> 00:07:48,301 FIT INTO THIS SPACE. 166 00:07:48,301 --> 00:07:52,339 THE FIRST IS A DRUG 167 00:07:52,339 --> 00:07:54,908 REPOSITIONING SCENARIO. 168 00:07:54,908 --> 00:07:59,112 THIS IS A CASE WHERE WHEN I 169 00:07:59,112 --> 00:08:03,750 FIRST JOINED AND WAS BROUGHT ON 170 00:08:03,750 --> 00:08:06,686 BOARD IN 2012 TO LEAD FOR 171 00:08:06,686 --> 00:08:09,222 PROGRAM REPOSITIONING WHERE DR. 172 00:08:09,222 --> 00:08:12,092 COLLINS HAD ACTUALLY ESTABLISHED 173 00:08:12,092 --> 00:08:13,393 PARTNERSHIPS WITH LARGE 174 00:08:13,393 --> 00:08:16,629 PHARMACEUTICAL COMPANIES PFIZER 175 00:08:16,629 --> 00:08:22,369 AND [INDISCERNIBLE] JANSSEN AND 176 00:08:22,369 --> 00:08:25,138 NEGOTIATED THAT THEY WOULD 177 00:08:25,138 --> 00:08:27,640 ACTUALLY MAKE AVAILABLE SOME 178 00:08:27,640 --> 00:08:29,409 CLINIC-READY ASSETS THAT HAD NOT 179 00:08:29,409 --> 00:08:37,417 MADE IT TO MARKET YET GENERALLY 180 00:08:37,417 --> 00:08:39,552 DEPRIORITIZED BY THEM AND 181 00:08:39,552 --> 00:08:41,421 REFERRED TO OFTEN AS SHELFED 182 00:08:41,421 --> 00:08:42,989 COMPOUNDS IF THEY WOULD MAKE 183 00:08:42,989 --> 00:08:51,564 THEM KNOWN TO RESEARCH COMMUNITY 184 00:08:51,564 --> 00:08:54,300 NIH THROUGH MCATS COULD PROVIDE 185 00:08:54,300 --> 00:08:55,969 CLINICAL TRIALS EXPLORING 186 00:08:55,969 --> 00:08:59,806 INDICATIONS FOR WELL-DEVELOPED 187 00:08:59,806 --> 00:09:03,143 ASSETS AND A THREE-WAY 188 00:09:03,143 --> 00:09:06,346 PARTNERSHIP WAS ESTABLISHED AND 189 00:09:06,346 --> 00:09:10,784 IN IT PHARMACEUTICAL COMPANIES 190 00:09:10,784 --> 00:09:12,986 AGREED TO MAKE AVAILABLE 191 00:09:12,986 --> 00:09:14,621 KNOWLEDGE OF THESE ASSETS THAT 192 00:09:14,621 --> 00:09:16,389 WOULD BE SORT OF MINIMAL 193 00:09:16,389 --> 00:09:18,024 KNOWLEDGE THAT WOULD BE OR WE 194 00:09:18,024 --> 00:09:20,560 WOULD PUT IN PUBLIC DOMAIN. 195 00:09:20,560 --> 00:09:25,598 WE POSTED IT ON THE MCATS 196 00:09:25,598 --> 00:09:25,965 WEBSITE. 197 00:09:25,965 --> 00:09:28,501 AND THROUGH THIS PROCESS THAT I 198 00:09:28,501 --> 00:09:29,903 WILL EXPLAIN MORE ABOUT THE 199 00:09:29,903 --> 00:09:33,306 PROCESS THROUGH THAT PROCESS FOR 200 00:09:33,306 --> 00:09:35,341 PROJECTS THAT WOULD END UP 201 00:09:35,341 --> 00:09:36,910 MOVING FORWARD EVENTUALLY AND 202 00:09:36,910 --> 00:09:39,112 TRIALS MOVING FORWARD, COMPANIES 203 00:09:39,112 --> 00:09:41,114 MADE CLINICAL SUPPLIES AVAILABLE 204 00:09:41,114 --> 00:09:45,285 AT NO COST TO NIH AND NO COST TO 205 00:09:45,285 --> 00:09:47,487 INVESTIGATORS AND THAT CLINICAL 206 00:09:47,487 --> 00:09:48,988 SUPPLY INCLUDED MATCH PLACEBO 207 00:09:48,988 --> 00:09:54,094 AND THEY MADE A PI ACTIVE 208 00:09:54,094 --> 00:09:55,595 PHARMACEUTICAL INGREEDIENT 209 00:09:55,595 --> 00:09:57,764 AVAILABLE IF PRECLINICAL STUDIES 210 00:09:57,764 --> 00:09:59,732 WERE NEEDED. 211 00:09:59,732 --> 00:10:01,267 THAT IS THEIR CONTRIBUTION 212 00:10:01,267 --> 00:10:02,869 THROUGH THIS PARTNERSHIP AND 213 00:10:02,869 --> 00:10:05,004 TURNING TO ACADEMIC 214 00:10:05,004 --> 00:10:07,574 INVESTIGATORS AND NIH INTRAMURAL 215 00:10:07,574 --> 00:10:10,176 PROGRAM TO SEE IF RESEARCHERS 216 00:10:10,176 --> 00:10:13,480 HAD IDEAS FOR INDICATIONS THAT 217 00:10:13,480 --> 00:10:16,249 THESE WELL-DEVELOPED ASSETS 218 00:10:16,249 --> 00:10:17,884 MIGHT BE GOOD FOR. 219 00:10:17,884 --> 00:10:20,820 THE -- YOU KNOW VALUE FOR THEM 220 00:10:20,820 --> 00:10:23,957 YOU KNOW IF YOU IMAGINE THAT YOU 221 00:10:23,957 --> 00:10:28,127 ARE A RESEARCHER SITTING IN AN 222 00:10:28,127 --> 00:10:31,498 ACADEMIC INSTITUTION OR SITTING 223 00:10:31,498 --> 00:10:36,302 AT IRP AND HAVE WHAT YOU BELIEVE 224 00:10:36,302 --> 00:10:40,340 TO BE A STRONG HYPOTHESIS FOR 225 00:10:40,340 --> 00:10:43,042 PARTICULAR ACTION AND MODULATION 226 00:10:43,042 --> 00:10:46,746 FOR TARGET WITH SMALL MOLECULE 227 00:10:46,746 --> 00:10:50,116 COULD HAVE POSITIVE IMPACT ON 228 00:10:50,116 --> 00:10:52,485 DISEASE AND YOU WANT TO PURSUE 229 00:10:52,485 --> 00:10:54,854 THAT AND KNOW IT WILL TAKE YOU 230 00:10:54,854 --> 00:10:56,656 OVER A DECADE AND GET TO POINT 231 00:10:56,656 --> 00:10:58,191 YOU ARE TAKING SOMETHING INTO 232 00:10:58,191 --> 00:10:59,225 THE CLINIC. 233 00:10:59,225 --> 00:11:01,494 THROUGH THIS PROGRAM WE WERE 234 00:11:01,494 --> 00:11:05,331 GETTING CLINIC READY ASSETS FROM 235 00:11:05,331 --> 00:11:08,501 PHARMACOMPANY IF YOUR TARGET 236 00:11:08,501 --> 00:11:10,103 MATCHED WITH MECHANISM OF ACTION 237 00:11:10,103 --> 00:11:14,173 OF DRUG BEING OFFERED BY 238 00:11:14,173 --> 00:11:14,807 PHARMACEUTICAL COMPANY YOU COULD 239 00:11:14,807 --> 00:11:19,546 TEST IN HUMANS IN LESS THAN A 240 00:11:19,546 --> 00:11:20,013 YEAR. 241 00:11:20,013 --> 00:11:26,386 THE -- SO IT IS THAT NEW IDEA OF 242 00:11:26,386 --> 00:11:31,024 NEW USE FOR THESE WELL DEVELOPED 243 00:11:31,024 --> 00:11:36,229 ASSETS THAT WE WERE TURNING TO 244 00:11:36,229 --> 00:11:39,632 ACADEMIC PARTNERS FOR AND 245 00:11:39,632 --> 00:11:42,835 NIHNCATS WOULD PROVIDE SUPPORT 246 00:11:42,835 --> 00:11:44,003 FOR CLINICAL TRIALS. 247 00:11:44,003 --> 00:11:46,706 ANOTHER IMPORTANT THING WE 248 00:11:46,706 --> 00:11:50,343 OFFERED WAS WE HAD BEFORE THIS 249 00:11:50,343 --> 00:11:53,746 INITIATIVE WAS LAUNCHED NIH HAD 250 00:11:53,746 --> 00:11:58,017 NEGOTIATED WITH EACH OF THE 251 00:11:58,017 --> 00:11:59,452 PHARMACEUTICAL COMPANIES 252 00:11:59,452 --> 00:12:00,553 COLLABORATIVE RESEARCH 253 00:12:00,553 --> 00:12:03,690 AGREEMENTS THAT WE CALLED 254 00:12:03,690 --> 00:12:06,826 TEMPLATE COLLABORATION RESOU 255 00:12:06,826 --> 00:12:08,194 SEARCH AGREEMENTS. 256 00:12:08,194 --> 00:12:10,330 EACH OF THE PHARMACEUTICAL 257 00:12:10,330 --> 00:12:12,966 COMPANIES SERVING AS A STARTING 258 00:12:12,966 --> 00:12:14,934 POINT FOR NEGOTIATION WITH 259 00:12:14,934 --> 00:12:16,669 ACADEMIC INSTITUTION AND IRP 260 00:12:16,669 --> 00:12:20,573 THAT WOULD COMMENT WITH AN IDEA 261 00:12:20,573 --> 00:12:21,174 FOR COLLABORATION. 262 00:12:21,174 --> 00:12:22,709 WITHOUT GOING INTO TOO MUCH 263 00:12:22,709 --> 00:12:24,777 DETAIL OF THE PROCESS, IT KICKS 264 00:12:24,777 --> 00:12:26,379 OFF WITH A PRE-APPLICATION FROM 265 00:12:26,379 --> 00:12:30,016 THE INVESTIGATORS. 266 00:12:30,016 --> 00:12:32,285 NIH WE ADVERTIZED FUNDING 267 00:12:32,285 --> 00:12:34,754 OPPORTUNITY ALONG WITH A LIST OF 268 00:12:34,754 --> 00:12:37,657 ASSETS COMING FROM THE COMPANIES 269 00:12:37,657 --> 00:12:45,465 THAT WERE ORDERED ACCORDING TO 270 00:12:45,465 --> 00:12:46,833 MECHANISM OF ACTION AND SEND US 271 00:12:46,833 --> 00:12:49,702 A PRE-APPLICATION AND IDEA IT IS 272 00:12:49,702 --> 00:12:51,571 A VERY SHORT PRE-APPLICATION AND 273 00:12:51,571 --> 00:12:53,873 NO THE ASKING FOR MONEY AT THIS 274 00:12:53,873 --> 00:12:55,808 POINT YOU DON'T HAVE ENOUGH 275 00:12:55,808 --> 00:12:56,709 INFORMATION AND JUST ENOUGH FOR 276 00:12:56,709 --> 00:12:58,645 YOU TO TELL I WANT TO ACTUALLY 277 00:12:58,645 --> 00:13:02,715 TALK WITH THIS COMPANY ABOUT TO 278 00:13:02,715 --> 00:13:05,151 LEARN MORE ABOUT THIS PARTICULAR 279 00:13:05,151 --> 00:13:06,152 ASSET THEY HAVE. 280 00:13:06,152 --> 00:13:08,454 IT MIGHT BE USEFUL FOR THE 281 00:13:08,454 --> 00:13:12,558 DISEASE I'M STUDYING THAT WENT 282 00:13:12,558 --> 00:13:16,629 THROUGH EXTERNAL REVIEW. 283 00:13:16,629 --> 00:13:19,866 PRE-APPLICATIONS WENT THROUGH 284 00:13:19,866 --> 00:13:20,533 EXTERNAL REVIEW. 285 00:13:20,533 --> 00:13:23,169 IF YOU MADE IT THROUGH THAT GATE 286 00:13:23,169 --> 00:13:25,371 YOU HAVE CONTACT WITH ASSET 287 00:13:25,371 --> 00:13:27,540 PROVIDER AND FIRST THING TO DO 288 00:13:27,540 --> 00:13:29,442 IS SIGN NON-DISCLOSURE AGREEMENT 289 00:13:29,442 --> 00:13:33,513 AND ACADEMIC RESEARCHER AND IRP 290 00:13:33,513 --> 00:13:34,714 RESEARCHER IS SHARING 291 00:13:34,714 --> 00:13:35,615 INFORMATION WITH THE COMPANY 292 00:13:35,615 --> 00:13:38,518 THAT IS TRYING TO CONVINCE THEM 293 00:13:38,518 --> 00:13:40,453 THAT THIS WOULD BE A WORTHWHILE 294 00:13:40,453 --> 00:13:44,057 THING FOR NIH TO INVEST IN AND 295 00:13:44,057 --> 00:13:45,758 PURSUE AND COMPANY IN MEANTIME 296 00:13:45,758 --> 00:13:49,495 IS NOW DISCLOSING MUCH MORE DATA 297 00:13:49,495 --> 00:13:53,599 THAN WE WOULD HAVE PUT ON OUR 298 00:13:53,599 --> 00:13:53,866 WEBSITE. 299 00:13:53,866 --> 00:13:55,702 SO, BOTH PARTIES AT THAT POINT 300 00:13:55,702 --> 00:13:59,005 WOULD HAVE TO AGREE IT IS WORTH 301 00:13:59,005 --> 00:14:00,973 MOVING FORWARD WITH AND FULL 302 00:14:00,973 --> 00:14:02,208 APPLICATION REQUESTING FUNDING 303 00:14:02,208 --> 00:14:07,780 SHOULD BE SUBMITTED TO NCATS. 304 00:14:07,780 --> 00:14:08,948 COMPANIES MIGHT SAY WE DON'T 305 00:14:08,948 --> 00:14:11,017 FEEL CONVINCED OR HAVE DONE 306 00:14:11,017 --> 00:14:13,086 OTHER STUDIES CLOSELY RELATED TO 307 00:14:13,086 --> 00:14:14,854 THIS DISEASE AND DON'T THINK IT 308 00:14:14,854 --> 00:14:16,422 WILL WORK AND DON'T WANT TO 309 00:14:16,422 --> 00:14:17,090 PURSUE IT. 310 00:14:17,090 --> 00:14:19,859 IN THAT CASE NO APPLICATION 311 00:14:19,859 --> 00:14:20,793 WOULD COME TO US. 312 00:14:20,793 --> 00:14:24,564 ACADEMIC RESEARCHER MIGHT HAVE 313 00:14:24,564 --> 00:14:26,766 LOOKED AT IT AND SAID YEAH. 314 00:14:26,766 --> 00:14:28,868 THIS PARTICULAR SIDE EFFECT THAT 315 00:14:28,868 --> 00:14:31,404 YOU WERE SEEING WHILE IT IS 316 00:14:31,404 --> 00:14:32,772 STILL, YOU KNOW, REASONABLE 317 00:14:32,772 --> 00:14:34,974 SAFETY PROFILE FOR THIS 318 00:14:34,974 --> 00:14:35,708 PARTICULAR LOCATION POPULATION 319 00:14:35,708 --> 00:14:37,643 THAT WON'T WORK AND IT DOESN'T 320 00:14:37,643 --> 00:14:43,483 GET PURSUED OR MOVE FORWARD. 321 00:14:43,483 --> 00:14:45,918 ALL THESE ASSETS HAVE AND FAILED 322 00:14:45,918 --> 00:14:48,554 TO HAVE SAFETY PROFILES 323 00:14:48,554 --> 00:14:49,789 GENERALLY DISCONTINUED FOR 324 00:14:49,789 --> 00:14:51,290 BUSINESS REASONS AND REALLY 325 00:14:51,290 --> 00:14:53,526 THERE WAS NO REASON 326 00:14:53,526 --> 00:14:55,027 SCIENTIFICALLY THAT WE COULDN'T 327 00:14:55,027 --> 00:14:56,796 ACTUALLY CONTINUE TO PURSUE 328 00:14:56,796 --> 00:14:57,130 THEM. 329 00:14:57,130 --> 00:14:59,398 WE NEEDED STRONG HYPOTHESIS AND 330 00:14:59,398 --> 00:15:00,967 EVIDENCE THAT THERE WAS A GOOD 331 00:15:00,967 --> 00:15:04,337 TIE BETWEEN THE MECHANISM OF 332 00:15:04,337 --> 00:15:07,473 ACTION AND OF DRUG AND DISEASE 333 00:15:07,473 --> 00:15:11,043 THAT THE INVESTIGATOR WAS 334 00:15:11,043 --> 00:15:11,711 INTERESTED IN. 335 00:15:11,711 --> 00:15:13,479 FOR THE -- FOR THE APPLICATIONS 336 00:15:13,479 --> 00:15:19,819 THAT CAME TO THE NIH THEY WENT 337 00:15:19,819 --> 00:15:23,956 THROUGH PEER REVIEW WE AS I SAID 338 00:15:23,956 --> 00:15:28,027 PROVIDED SUPPORT FOR PHASE 1 IF 339 00:15:28,027 --> 00:15:29,996 NEEDED AND PHASE 2 CLINICAL 340 00:15:29,996 --> 00:15:32,165 TRIALS AS WELL AS NON-CLINICAL 341 00:15:32,165 --> 00:15:34,867 STUDIES THAT MIGHT BE NEEDED. 342 00:15:34,867 --> 00:15:38,738 FOR EXAMPLE WE HAD A CASE WHERE 343 00:15:38,738 --> 00:15:42,909 WE HAD AN ASSET THAT HAD BEEN 344 00:15:42,909 --> 00:15:47,547 DEVELOPED BY ASTO ZEN EBBINGA 345 00:15:47,547 --> 00:15:50,983 THAT WAS EXCLUSIVELY EXPLORED 346 00:15:50,983 --> 00:15:53,586 FOR VARIOUS ONCOLOGY INDICATIONS 347 00:15:53,586 --> 00:15:55,321 AND THEY HAD ONLY DONE TOP 348 00:15:55,321 --> 00:15:57,857 STUDIES FOR SHORT-TERM USE OR 349 00:15:57,857 --> 00:15:59,025 SHORT-TERM ADMINISTRATION AND 350 00:15:59,025 --> 00:16:01,994 NEW IDEA WAS TO USE THIS FOR 351 00:16:01,994 --> 00:16:04,564 ALZHEIMER'S THAT WOULD BE 352 00:16:04,564 --> 00:16:05,598 CHRONIC ADMINISTRATION. 353 00:16:05,598 --> 00:16:08,968 WE HAD TO SUPPORT NON-CLINICAL 354 00:16:08,968 --> 00:16:10,670 STUDIES TO MAKE SURE THAT THIS 355 00:16:10,670 --> 00:16:13,272 WOULD BE OKAY TO ADMINISTER THIS 356 00:16:13,272 --> 00:16:16,909 DRUG AT A LOWER DOSE AND MUCH 357 00:16:16,909 --> 00:16:18,477 LONGER PERIOD OF TIME. 358 00:16:18,477 --> 00:16:21,247 THAT WOULD BE EXAMPLE OF 359 00:16:21,247 --> 00:16:22,448 NON-CLINICAL STUDIES THAT WOULD 360 00:16:22,448 --> 00:16:25,184 HAVE TO BE DONE WITH AN ALREADY 361 00:16:25,184 --> 00:16:26,886 WELL-DEVELOPED ASSET THAT HAS 362 00:16:26,886 --> 00:16:30,323 BEEN THROUGH ALREADY CLINICAL 363 00:16:30,323 --> 00:16:30,690 TRIALS. 364 00:16:30,690 --> 00:16:35,161 AND SO THROUGH THE MODEL WHAT 365 00:16:35,161 --> 00:16:38,598 MCATS WAS TRYING TO TEST WAS THE 366 00:16:38,598 --> 00:16:41,868 MODEL OF PARTNERSHIP. 367 00:16:41,868 --> 00:16:46,005 IF A COMPANY MAKES LIMITED 368 00:16:46,005 --> 00:16:48,241 INFORMATION ABOUT ASSETS 369 00:16:48,241 --> 00:16:50,309 AVAILABLE WILL IT BE SUFFICIENT 370 00:16:50,309 --> 00:16:52,879 TO JUMP START POTENTIAL 371 00:16:52,879 --> 00:16:54,780 PARTNERSHIP AND COLLABORATION? 372 00:16:54,780 --> 00:16:59,452 YOU KNOW, OUR HOPE WAS THAT WE 373 00:16:59,452 --> 00:17:01,487 WOULD DEMONSTRATE THIS MODEL 374 00:17:01,487 --> 00:17:06,659 COULD WORK AND USING TEMPLATE 375 00:17:06,659 --> 00:17:09,528 COLLABORATION AGREEMENTS AS A 376 00:17:09,528 --> 00:17:11,297 STARTING POINT WOULD RELIEVE 377 00:17:11,297 --> 00:17:12,932 NEGOTIATION AND BURDEN OFF THE 378 00:17:12,932 --> 00:17:15,401 LEGAL TEAMS AND COMPANIES AND 379 00:17:15,401 --> 00:17:18,170 THAT THIS WOULD ACTUALLY BE A 380 00:17:18,170 --> 00:17:21,240 WORTHWHILE THING FOR COMPANIES 381 00:17:21,240 --> 00:17:24,010 TO PURSUE ON THEIR OWN WITHOUT 382 00:17:24,010 --> 00:17:28,981 HAVING NCATS OR NIH AND IN FACT 383 00:17:28,981 --> 00:17:31,250 ASTROZEN EBBING KA IF YOU GOOGLE 384 00:17:31,250 --> 00:17:33,286 NOW AND WANT YOU TO PAY 385 00:17:33,286 --> 00:17:34,687 ATTENTION TO THE SESSION AND 386 00:17:34,687 --> 00:17:38,090 WHEN IT IS OVER AND GOOGLE 387 00:17:38,090 --> 00:17:39,592 ASTROZEN EBBINGA YOU WILL SEE 388 00:17:39,592 --> 00:17:43,129 THEY HAVE DONE WHAT WE DID WITH 389 00:17:43,129 --> 00:17:46,365 OUR PROGRAM. 390 00:17:46,365 --> 00:17:49,235 THEY HAVE A SET OF COMPOUNDS 391 00:17:49,235 --> 00:17:52,905 AVAILABLE FOR EXPLORATION IN 392 00:17:52,905 --> 00:17:53,806 PRECLINICAL STUDIES AND HAVE 393 00:17:53,806 --> 00:17:55,608 SOME AVAILABLE FOR EXPLORATION 394 00:17:55,608 --> 00:17:59,312 ON CLINICAL STUDIES AFTER YOUR 395 00:17:59,312 --> 00:18:01,981 IDEA AND PROPOSAL MAKES IT 396 00:18:01,981 --> 00:18:05,017 THROUGH A REVIEW PROCESS 397 00:18:05,017 --> 00:18:07,587 CONDUCTED BY ASTO ZEN EBBINGA 398 00:18:07,587 --> 00:18:09,355 THAT THEY DECIDE WOULD BE WORTH 399 00:18:09,355 --> 00:18:12,391 PURSUING AND EVEN THOUGH ASSETS 400 00:18:12,391 --> 00:18:13,960 ARE DEVELOPED BY THEM IT STILL 401 00:18:13,960 --> 00:18:17,930 TAKES TIME AND RESOURCES ON 402 00:18:17,930 --> 00:18:20,566 THEIR PART TO PURSUE A 403 00:18:20,566 --> 00:18:23,002 PARTNERSHIP OR COLLABORATION 404 00:18:23,002 --> 00:18:24,704 WITH ANYBODY. 405 00:18:24,704 --> 00:18:28,507 THIS WAS A MODEL THAT WAS 406 00:18:28,507 --> 00:18:30,643 SPECIFICALLY DEVELOPED FOR DRUG 407 00:18:30,643 --> 00:18:31,811 REPOSITIONING. 408 00:18:31,811 --> 00:18:32,578 REPOSITIONING SOMETHING THAT 409 00:18:32,578 --> 00:18:36,983 HASN'T MADE IT TO MARKET YET 410 00:18:36,983 --> 00:18:37,917 ACTUALLY. 411 00:18:37,917 --> 00:18:39,518 MOST COMMON QUERY MY OFFICE 412 00:18:39,518 --> 00:18:40,953 DWETS IS ACTUALLY FROM PEOPLE 413 00:18:40,953 --> 00:18:45,124 WHO ACTUALLY WANT TO PURSUE 414 00:18:45,124 --> 00:18:47,426 REPURPOSING A MARKETED DRUG. 415 00:18:47,426 --> 00:18:48,361 THIS IS NATURAL. 416 00:18:48,361 --> 00:18:50,096 THESE ARE THE THINGS THAT PEOPLE 417 00:18:50,096 --> 00:18:51,230 KNOW THE MOST ABOUT. 418 00:18:51,230 --> 00:18:54,700 SO, OF COURSE, THIS IS WHAT 419 00:18:54,700 --> 00:18:59,372 PEOPLE WANT TO PURSUE. 420 00:18:59,372 --> 00:19:01,173 UNFORTUNATELY, THIS IS EXTREMELY 421 00:19:01,173 --> 00:19:01,507 CHALLENGING. 422 00:19:01,507 --> 00:19:05,044 THERE IS LIMITED PATHS TO A 423 00:19:05,044 --> 00:19:06,312 RETURN ON INVESTMENT. 424 00:19:06,312 --> 00:19:09,548 WHEN YOU HAVE TO, YOU KNOW, 425 00:19:09,548 --> 00:19:12,718 STILL PAY FOR CLINICAL TRIALS 426 00:19:12,718 --> 00:19:13,586 AND EVERYTHING. 427 00:19:13,586 --> 00:19:17,423 REASON THERE IS A LIMITED 428 00:19:17,423 --> 00:19:20,226 ABILITY TO RECOUP INVESTMENT YOU 429 00:19:20,226 --> 00:19:23,863 MAKE IS BECAUSE IN MOST CASES 430 00:19:23,863 --> 00:19:26,699 DRUGS ALREADY HAVE GENERIC 431 00:19:26,699 --> 00:19:28,401 COMPETITORS ON THE MARKET. 432 00:19:28,401 --> 00:19:30,503 IF THEY DON'T HAVE THEM NOW THEY 433 00:19:30,503 --> 00:19:35,274 WILL SHORTLY HAVE GENETIC 434 00:19:35,274 --> 00:19:38,044 COMPETITORS ON THE MARKET YOU 435 00:19:38,044 --> 00:19:40,546 MIGHT BE ABLE TO BE AWARDED A 436 00:19:40,546 --> 00:19:44,050 USE PATENT FOR THIS MARKETED 437 00:19:44,050 --> 00:19:46,085 DRUG BECAUSE THERE ARE GENERIC 438 00:19:46,085 --> 00:19:48,754 COMPETITORS ON THE MARKET, THERE 439 00:19:48,754 --> 00:19:55,561 IS NOTHING TO PREVENT THE PAYERS 440 00:19:55,561 --> 00:19:59,532 REIMBURSING FOR GENERIC OR 441 00:19:59,532 --> 00:20:01,267 PHYSICIAN TO PRESCRIBE GENERIC 442 00:20:01,267 --> 00:20:06,238 OR PATIENT TO REREQUEST THE 443 00:20:06,238 --> 00:20:07,573 GENERIC DRUG BECAUSE THEY HAVE 444 00:20:07,573 --> 00:20:08,808 THE EXPANDED LABEL FOR IT. 445 00:20:08,808 --> 00:20:12,912 IT MAKES IT EXTREMELY DIFFICULT. 446 00:20:12,912 --> 00:20:15,681 THERE ARE PATHS THAT WILL WORK. 447 00:20:15,681 --> 00:20:18,484 THEY HAVE BEEN MENTIONED THAT 448 00:20:18,484 --> 00:20:19,719 CHANGING FORMULATION IS A 449 00:20:19,719 --> 00:20:21,387 STRATEGY THAT WILL WORK AND WE 450 00:20:21,387 --> 00:20:25,958 WILL HEAR MORE ABOUT THAT IN THE 451 00:20:25,958 --> 00:20:26,225 SESSION. 452 00:20:26,225 --> 00:20:30,629 ANYTHING WHERE YOU CHANGE ROUTE 453 00:20:30,629 --> 00:20:32,098 OF ADMINISTRATION OR CHANGE 454 00:20:32,098 --> 00:20:35,601 ACTIVE INGREDIENTS TO HAVE TWO 455 00:20:35,601 --> 00:20:37,536 ACTIVE INGREDIENTS AND 456 00:20:37,536 --> 00:20:38,804 COMBINATION THERAPY OR IF YOU 457 00:20:38,804 --> 00:20:41,474 CHANGE SO YOU HAVE AN EXTENDED 458 00:20:41,474 --> 00:20:44,143 RELEASE FORMULATION, THESE ARE 459 00:20:44,143 --> 00:20:46,812 THINGS WHERE YOU WOULD HAVE THAT 460 00:20:46,812 --> 00:20:48,180 HAVING THAT PATENT THAT WOULD 461 00:20:48,180 --> 00:20:50,616 ACTUALLY BE USEFUL OR HAVING 462 00:20:50,616 --> 00:20:52,651 EXCLUSIVITY FROM THE FDA WOULD 463 00:20:52,651 --> 00:20:55,821 BE USEFUL AND AS LONG AS THERE 464 00:20:55,821 --> 00:20:58,624 IS A GENETIC COMPETITOR IT IS 465 00:20:58,624 --> 00:21:00,559 EXTREMELY NO WAY FOR YOU TO 466 00:21:00,559 --> 00:21:01,827 RECOUP THAT INVESTMENT. 467 00:21:01,827 --> 00:21:05,498 WHEN I SAY THAT, THAT IS FROM 468 00:21:05,498 --> 00:21:08,267 THE PERSPECTIVE FROM A DRUG 469 00:21:08,267 --> 00:21:11,737 DEVELOPER, FROM A DRUG 470 00:21:11,737 --> 00:21:13,405 DEVELOPER'S PERSPECTIVE THERE IS 471 00:21:13,405 --> 00:21:16,575 LITTLE MOTATION FOR THIS REASON 472 00:21:16,575 --> 00:21:20,045 HAVING GENERICS ON THE MARKET 473 00:21:20,045 --> 00:21:21,881 THINKING FROM PERSPECTIVE FROM A 474 00:21:21,881 --> 00:21:24,250 PAYER AND INSURANCE COMPANIES 475 00:21:24,250 --> 00:21:27,319 THEY ARE ONES THAT WOULD STAND 476 00:21:27,319 --> 00:21:28,554 TO BENEFIT. 477 00:21:28,554 --> 00:21:30,089 IF YOU IMAGINE THAT SOMEBODY HAS 478 00:21:30,089 --> 00:21:34,059 AN IDEA FOR REPURPOSING A 479 00:21:34,059 --> 00:21:35,060 MARKETED DRUG TO TREAT A 480 00:21:35,060 --> 00:21:37,930 CONDITION THAT IS COSTLY TO THE 481 00:21:37,930 --> 00:21:38,964 HEALTHCARE SYSTEM BECAUSE OF A 482 00:21:38,964 --> 00:21:42,735 LARGE NUMBER OF PATIENTS OR 483 00:21:42,735 --> 00:21:46,806 BECAUSE AND NO TREATMENT IS 484 00:21:46,806 --> 00:21:49,575 AVAILABLE OR CURRENT TREATMENTS 485 00:21:49,575 --> 00:21:51,544 ARE EXPENSIVE AND THERE IS SEC 486 00:21:51,544 --> 00:21:52,745 WELLY AND NOT TREATMENT 487 00:21:52,745 --> 00:21:54,280 AVAILABLE THAT MAKE IT COSTLY TO 488 00:21:54,280 --> 00:21:57,850 THE HEALTHCARE SYSTEM AND FROM 489 00:21:57,850 --> 00:21:59,818 PAYER'S PERSPECTIVE DISEASES ARE 490 00:21:59,818 --> 00:22:02,121 COSTING LOTS OF MONEY AND IF WE 491 00:22:02,121 --> 00:22:04,523 CAN TREAT IT WAY GENERIC DRUG 492 00:22:04,523 --> 00:22:07,293 THAT COULD BE INEXPENSIVE COULD 493 00:22:07,293 --> 00:22:10,362 MAKE A SIGNIFICANT DIFFERENCE 494 00:22:10,362 --> 00:22:12,398 FOR THEM. 495 00:22:12,398 --> 00:22:14,133 SO FAR WE ARE NOT THOUGHT ABOUT 496 00:22:14,133 --> 00:22:16,936 THE PAYERS OR FOCUSED ON PAYERS 497 00:22:16,936 --> 00:22:19,705 AND SPACE OF REPURPOSING GENERIC 498 00:22:19,705 --> 00:22:21,040 DRUGS THIS IS SPACE WE WILL NEED 499 00:22:21,040 --> 00:22:24,243 TO GET INTO AND IS THE COMMUNITY 500 00:22:24,243 --> 00:22:26,645 WE HAVE TO ENGAGE AND AS YOU 501 00:22:26,645 --> 00:22:27,713 KNOW THAT IS NOT SOMETHING THEY 502 00:22:27,713 --> 00:22:30,983 ARE THINKING ABOUT THAT WILL 503 00:22:30,983 --> 00:22:37,122 TAKE VERY INTENTIONAL 504 00:22:37,122 --> 00:22:39,291 INTERACTIONS WITH THEM TO 505 00:22:39,291 --> 00:22:41,794 EXPLAIN TO THEM WHY THIS WILL BE 506 00:22:41,794 --> 00:22:43,596 BENEFICIAL TO THEM AND WHY THIS 507 00:22:43,596 --> 00:22:46,632 IS SOMETHING THEY SHOULD START 508 00:22:46,632 --> 00:22:50,469 TO THINK ABOUT. 509 00:22:50,469 --> 00:22:55,774 I'LL STOP THERE AND HAND IT TO 510 00:22:55,774 --> 00:22:57,309 DEDETO INTRODUCE THE NEXT 511 00:22:57,309 --> 00:22:58,410 PANELIST, I SHOULD SAY. 512 00:22:58,410 --> 00:23:02,715 >> THANK YOU. THIS WAS A VERY 513 00:23:02,715 --> 00:23:04,984 NICE INTRODUCTION AND KNOW ABOUT 514 00:23:04,984 --> 00:23:07,920 THE ASTROZEN EBBINGA PROGRAM 515 00:23:07,920 --> 00:23:12,558 THAT IS PRETTY AWESOME. NEXT 516 00:23:12,558 --> 00:23:18,030 SPEAKER IS ANJUNG. 517 00:23:18,030 --> 00:23:25,838 TELL US ABOUT YOURSELF AND YOUR 518 00:23:25,838 --> 00:23:26,038 WORK. 519 00:23:26,038 --> 00:23:30,809 >> THANK YOU DEDEAND CHRISTINE 520 00:23:30,809 --> 00:23:32,578 FOR THAT OVERVIEW. 521 00:23:32,578 --> 00:23:36,048 I HAVE BEEN WORKING IN THE 522 00:23:36,048 --> 00:23:42,454 PHARMACEUTICAL BIOTECH CRO 523 00:23:42,454 --> 00:23:45,424 INDUSTRY AND CAREER PARTNER AT A 524 00:23:45,424 --> 00:23:47,092 VENTURE FUND AND RECENT PRODUCT 525 00:23:47,092 --> 00:23:51,630 IS STARTING MY OWN COMPANY 526 00:23:51,630 --> 00:23:54,633 CALLED RIA THERAPEUTIC THAT IS 527 00:23:54,633 --> 00:23:58,003 NAMED AFTER MY FATHER WHO PASSED 528 00:23:58,003 --> 00:24:02,374 AWAY FROM ALS HE WAS DIAGNOSED 529 00:24:02,374 --> 00:24:05,544 IN DECEMBER OF 2010 AND AFTER 530 00:24:05,544 --> 00:24:07,379 DIAGNOSIS I BECAME INVOLVED IN 531 00:24:07,379 --> 00:24:10,582 ALS COMMUNITY IF YOU WILL WENT 532 00:24:10,582 --> 00:24:14,653 TO CONFERENCES TALKING WITH ALS 533 00:24:14,653 --> 00:24:16,488 RESEARCHERS AND CLINICIANS AND 534 00:24:16,488 --> 00:24:19,158 YOU KNOW EVEN JOINED THE BOARD 535 00:24:19,158 --> 00:24:21,694 OF THE MUSCULAR DISTROPHY 536 00:24:21,694 --> 00:24:24,396 ASSOCIATION AND LARGEST 537 00:24:24,396 --> 00:24:26,198 NON-PROFIT FOR NEUROMUSCULAR 538 00:24:26,198 --> 00:24:28,033 DISEASES IN THE US AND IN NUMBER 539 00:24:28,033 --> 00:24:32,237 OF YEARS I CAME ACROSS SEVERAL 540 00:24:32,237 --> 00:24:35,374 CLINICAL STAGE DRUGS THAT WERE 541 00:24:35,374 --> 00:24:37,810 ALL DRUGS THAT AT LEAST WENT 542 00:24:37,810 --> 00:24:38,577 THROUGH PHASE 2. 543 00:24:38,577 --> 00:24:40,980 THEY ALL WERE ORIGINALLY 544 00:24:40,980 --> 00:24:42,314 DEVELOPED FOR NEUROLOGICAL 545 00:24:42,314 --> 00:24:44,583 INDICATIONS THAT WERE, YOU KNOW, 546 00:24:44,583 --> 00:24:47,019 NOT ALS. 547 00:24:47,019 --> 00:24:50,990 AND, YOU KNOW, DEPRIORITIZED IF 548 00:24:50,990 --> 00:24:53,726 YOU WILL FOR MOSTLY BUSINESS 549 00:24:53,726 --> 00:24:55,094 REASONS THAT CERTAINLY SOME NONE 550 00:24:55,094 --> 00:24:56,895 OF THEM WERE DUE TO SAFETY 551 00:24:56,895 --> 00:24:58,330 REASONS THAT IS IMPORTANT. 552 00:24:58,330 --> 00:25:00,432 WHEN I CAME ACROSS THEM I'M NOT 553 00:25:00,432 --> 00:25:01,700 A SCIENTIST. 554 00:25:01,700 --> 00:25:03,402 I KNEW ENOUGH THAT THEY LOOKED 555 00:25:03,402 --> 00:25:06,138 LIKE THEY COULD HAVE POTENTIAL 556 00:25:06,138 --> 00:25:07,673 IN ALS. 557 00:25:07,673 --> 00:25:12,544 I WENT TO REAL ALS EXPERTS AND 558 00:25:12,544 --> 00:25:15,647 ASKED THEM TO CONDUCT DILIGENCE 559 00:25:15,647 --> 00:25:18,917 ON VARIOUS DRUGS AND MECHANISMS 560 00:25:18,917 --> 00:25:21,387 AND TARGETS AND POTENTIAL TO 561 00:25:21,387 --> 00:25:25,157 TREAT ALS AND SMALL MOLECULE AND 562 00:25:25,157 --> 00:25:27,893 BLOOD BRAIN BARRIER AND OFFER 563 00:25:27,893 --> 00:25:29,561 PROTECTION AROUND THE MOTOR 564 00:25:29,561 --> 00:25:29,795 NEURON. 565 00:25:29,795 --> 00:25:31,897 AND THE EXPERTS CAME BACK TO ME 566 00:25:31,897 --> 00:25:34,299 AND SAID ABSOLUTELY THERE WERE 567 00:25:34,299 --> 00:25:36,268 REASONS AND BIOLOGIC RATIONALE 568 00:25:36,268 --> 00:25:38,337 WHY THESE DRUGS COULD WORK AND I 569 00:25:38,337 --> 00:25:41,540 WENT BACK TO EACH OF THE 570 00:25:41,540 --> 00:25:44,643 COMPANIES AND SAID YOU DON'T 571 00:25:44,643 --> 00:25:46,979 APPEAR TO BE YOU KNOW PUTTING 572 00:25:46,979 --> 00:25:52,785 LOTS OF PRIORITY ON XOUCOMPOUND 573 00:25:52,785 --> 00:25:53,919 AND DEVELOPMENT AND THERE IS 574 00:25:53,919 --> 00:25:55,120 OPPORTUNITY HERE AND I WILL TELL 575 00:25:55,120 --> 00:25:58,924 YOU ABOUT IT AND ALS IS A HIGHLY 576 00:25:58,924 --> 00:26:01,226 UNMET NEED AND DEADLY DISEASE 577 00:26:01,226 --> 00:26:04,430 AND NOT WELL-UNDERSTOOD AND VAST 578 00:26:04,430 --> 00:26:06,865 MAJORITY OF LS PATIENTS HAVE 579 00:26:06,865 --> 00:26:09,868 SPORADIC ALS THAT IS NOT 580 00:26:09,868 --> 00:26:11,437 NECESSARILY HAVING DEFINED 581 00:26:11,437 --> 00:26:13,906 ETIOLOGY OR GENETIC MAKEUP. 582 00:26:13,906 --> 00:26:18,210 IT TOOK A WHILE AND ALMOST FOUR 583 00:26:18,210 --> 00:26:19,011 YEARS. 584 00:26:19,011 --> 00:26:22,414 BUT, RIA HAS LICENSED FIVE 585 00:26:22,414 --> 00:26:25,551 CLINICAL STAGE COMPOUNDS AND 586 00:26:25,551 --> 00:26:26,885 COMPLETED AT LEAST PHASE 2. 587 00:26:26,885 --> 00:26:29,488 YOU KNOW, I KIND OF JOKE THAT WE 588 00:26:29,488 --> 00:26:32,458 ARE THE ONLY BIOTECH IN THE 589 00:26:32,458 --> 00:26:34,660 WORLD THAT HAS MORE DRUGS THAN 590 00:26:34,660 --> 00:26:35,894 PEOPLE, BELIEVE IT OR NOT. 591 00:26:35,894 --> 00:26:38,063 WHAT WE HAVE BEEN WORKING ON 592 00:26:38,063 --> 00:26:43,735 RECENTLY IS TRYING TO DEVELOP 593 00:26:43,735 --> 00:26:45,070 DRUGS FURTHER AND THERE IS GAP 594 00:26:45,070 --> 00:26:46,839 FILLING TO DO AND DRUGS ARE 595 00:26:46,839 --> 00:26:48,907 OLDER AND HAVE TO BE 596 00:26:48,907 --> 00:26:51,043 MANUFACTURED AT NEW SITES AND 597 00:26:51,043 --> 00:26:52,277 VALIDATE MANUFACTURING PROCESSES 598 00:26:52,277 --> 00:26:54,646 AND HAVE TO GO THROUGH 599 00:26:54,646 --> 00:26:58,383 REGULATORY PATHWAY TALKING TO 600 00:26:58,383 --> 00:27:01,220 REGULATORY AGENCIES ABOUT A NEW 601 00:27:01,220 --> 00:27:04,590 INDICATION AND WE ARE CURRENTLY 602 00:27:04,590 --> 00:27:09,428 GOING THROUGH THAT HOPING TO 603 00:27:09,428 --> 00:27:14,333 LAUNCH A 5-ARM PLATFORM WITH 604 00:27:14,333 --> 00:27:19,004 DRUGS AND MECHANISMS AND 605 00:27:19,004 --> 00:27:24,109 TREATMENT OF ALS THAT IS AN 606 00:27:24,109 --> 00:27:26,378 AMBITIOUS TREATMENT AND 607 00:27:26,378 --> 00:27:29,314 HIGHLIGHTING ABOUT PROJECTS IS 608 00:27:29,314 --> 00:27:33,085 IF YOU LOOK AT FUTURE OF 609 00:27:33,085 --> 00:27:33,886 NEURODEGENERATIVE DISEASES AND 610 00:27:33,886 --> 00:27:37,256 DR. STOT WILL TALK ABOUT THIS 611 00:27:37,256 --> 00:27:38,891 SPECIFICALLY AROUND PARKINSON'S 612 00:27:38,891 --> 00:27:43,629 AND NUMBER OF NEURODEGENERATIVE 613 00:27:43,629 --> 00:27:50,469 DISEASES WILL REQUIRE 614 00:27:50,469 --> 00:27:56,542 COMBINATION TREATMENT IN THE 615 00:27:56,542 --> 00:28:00,579 FUTURE ALL THESE REQUIRE 616 00:28:00,579 --> 00:28:02,714 COCKTAILS OF DRUGS WITH 617 00:28:02,714 --> 00:28:08,620 DIFFERENT MECHANISMS AND ALS IS 618 00:28:08,620 --> 00:28:11,223 NOT GOING TO BE DIFFERENT THAN 619 00:28:11,223 --> 00:28:13,458 THAT. MULTIFACTORIAL DISEASE 620 00:28:13,458 --> 00:28:17,362 AND IN ADDITION TO DEVELOPING 621 00:28:17,362 --> 00:28:18,397 DRUGS INDIVIDUALLY AS A 622 00:28:18,397 --> 00:28:19,865 MONOTHERAPY WE HAVE STARTED TO 623 00:28:19,865 --> 00:28:22,935 DO COMBINATION DEVELOPMENT IN 624 00:28:22,935 --> 00:28:25,304 PRECLINICAL ALS MODEL TESTING 625 00:28:25,304 --> 00:28:27,472 DRUGS BY THEMSELVES AND IN 626 00:28:27,472 --> 00:28:29,007 COMBINATION WITH EACH OATH AND 627 00:28:29,007 --> 00:28:32,544 INVEEF TROE MODELS AND IN VIVO 628 00:28:32,544 --> 00:28:35,147 MODELS THAT IS LIKE A BAIK OFF 629 00:28:35,147 --> 00:28:37,683 AND TRYING TO FIND BEST 630 00:28:37,683 --> 00:28:47,492 COMBINATION AND EVENTUALLY MOVE 631 00:28:47,492 --> 00:28:49,595 FORWARD AND NOT FOR PAINT AT 632 00:28:49,595 --> 00:28:51,330 HEART FOR SURE AND CERTAINLY IS 633 00:28:51,330 --> 00:28:53,732 MORE CHALLENGING FROM THE 634 00:28:53,732 --> 00:28:55,434 PERSPECTIVE OF THESE FIVE DRUGS 635 00:28:55,434 --> 00:28:56,969 THAT THEY ARE IN SENSE THEY ARE 636 00:28:56,969 --> 00:28:59,004 A NEW CHEMICAL ENTITY AND 637 00:28:59,004 --> 00:29:02,274 LOOKING AT COMBINATION 638 00:29:02,274 --> 00:29:06,078 DEVELOPMENT IN ONCOLOGY IT IS 639 00:29:06,078 --> 00:29:09,615 APPROVED DRUGLIKE NTRUDA ANDS 640 00:29:09,615 --> 00:29:12,150 DOENS OF APPROVED DRUG AND IN 641 00:29:12,150 --> 00:29:16,588 CASE OF ALS YOU DON'T HAVE A 642 00:29:16,588 --> 00:29:25,964 TRULY ESTABLISHED STANDARD OF 643 00:29:25,964 --> 00:29:29,368 CARE NETWORKS AND LOOKING AT 644 00:29:29,368 --> 00:29:34,139 COMBINING CHEMICAL ENTITIES 645 00:29:34,139 --> 00:29:37,409 DEVELOPING THIS WAY THAT IS RARE 646 00:29:37,409 --> 00:29:42,714 IN OUR INDUSTRY TO DO AND 647 00:29:42,714 --> 00:29:44,449 FINDING DRUGS UNDER ONE ROOF AND 648 00:29:44,449 --> 00:29:48,887 TRYING TO GET FIVE BIOTECHES TO 649 00:29:48,887 --> 00:29:51,823 COLLABORATE ON COMBINATION 650 00:29:51,823 --> 00:29:55,260 DEVELOPMENT THAT WILL BE 651 00:29:55,260 --> 00:30:05,804 CHALLENGING TO SAY THE LEAST 652 00:30:10,542 --> 00:30:10,676 AND. 653 00:30:10,676 --> 00:30:13,412 ONE THING THAT IS GIVEN A 654 00:30:13,412 --> 00:30:15,881 BACKGROUND WORKING AT BIG 655 00:30:15,881 --> 00:30:17,149 PHARMA-AND AT A VENTURE FUND AND 656 00:30:17,149 --> 00:30:19,885 MY -- YOU KNOW, MY WORK 657 00:30:19,885 --> 00:30:22,087 EXPERIENCE WAS PRIMARILY AROUND 658 00:30:22,087 --> 00:30:24,556 LICENSING AND MERGERS AND 659 00:30:24,556 --> 00:30:26,024 ACQUISITIONS AND KNEW THAT IT 660 00:30:26,024 --> 00:30:28,927 WOULD BE A LOT MORE CHALLENGING 661 00:30:28,927 --> 00:30:32,698 TO PITCH THIS STORY, IF YOU 662 00:30:32,698 --> 00:30:35,267 WILL, TO POTENTIAL INVESTORS IF 663 00:30:35,267 --> 00:30:38,203 THESE WERE APPROVED DRUGS THAT 664 00:30:38,203 --> 00:30:41,707 WERE BEING REPURPOSED. 665 00:30:41,707 --> 00:30:44,076 AGAIN, AS CHRISTINE AND 666 00:30:44,076 --> 00:30:46,078 DEDETALKED ABOUT, THESE DRUGS 667 00:30:46,078 --> 00:30:49,715 WOULD REPURPOSE WAY I SEE IT AND 668 00:30:49,715 --> 00:30:51,650 BCS AND BIG PHARMA-AND THEY SEE 669 00:30:51,650 --> 00:30:53,752 IT AS THESE ARE OLDER DRUGS THAT 670 00:30:53,752 --> 00:30:56,188 HAVE GENERICS AND SOMEBODY IS 671 00:30:56,188 --> 00:30:58,423 TRYING TO CREATE A NEW VERSION 672 00:30:58,423 --> 00:31:00,959 OR COULD BE REFORMULATED OR 673 00:31:00,959 --> 00:31:02,928 COULD BE A DIFFERENT STRENGTH, 674 00:31:02,928 --> 00:31:04,563 ET CETERA. 675 00:31:04,563 --> 00:31:15,107 EFFECTIVELY THESE ARE DRUGS WITH 676 00:31:17,943 --> 00:31:28,420 GENERIC COMPOUNDS AVAILABLE -- 677 00:32:21,640 --> 00:32:24,342 OVERALL, I WOULD HAVE TO SAY 678 00:32:24,342 --> 00:32:27,512 THAT MY PERSONAL EXPERIENCE HAS 679 00:32:27,512 --> 00:32:30,749 BEEN IT IS MORE CHALLENGING TO 680 00:32:30,749 --> 00:32:33,518 PIT YOUR STORY WITH REPURPOSED 681 00:32:33,518 --> 00:32:37,189 DRUGS UNFAIRLY, PERHAPS, TO 682 00:32:37,189 --> 00:32:40,992 INVESTORS AND PHARMACEUTICAL 683 00:32:40,992 --> 00:32:45,197 COMPANIES THAN NEW CHEMICAL 684 00:32:45,197 --> 00:32:45,463 ENTITIES. 685 00:32:45,463 --> 00:32:47,032 I WILL PAUSE AND PASS IT OVER 686 00:32:47,032 --> 00:32:49,100 AND I'M HAPPY TO ANSWER 687 00:32:49,100 --> 00:32:50,402 ADDITIONAL QUESTIONS THAT 688 00:32:50,402 --> 00:32:52,470 CERTAINLY POTENTIAL ROLE OF THE 689 00:32:52,470 --> 00:32:57,642 NIH AND HOW THEY COULD PLAY WHAT 690 00:32:57,642 --> 00:33:00,812 ROLE THEY COULD PLAY WITH A 691 00:33:00,812 --> 00:33:02,914 REPOSITORY FOR QUOTE ON QUOTE 692 00:33:02,914 --> 00:33:04,149 SHELFED PHARMACEUTICAL ASSETS 693 00:33:04,149 --> 00:33:07,886 THAT WE HAVE TO HAVE A CARROT 694 00:33:07,886 --> 00:33:10,288 APPROACH AND OFFER INCREASED 695 00:33:10,288 --> 00:33:12,257 LEVELS OF PROTECTION FOR 696 00:33:12,257 --> 00:33:13,658 PHARMACEUTICAL COMPANIES TO BE 697 00:33:13,658 --> 00:33:14,926 REALLY MORE INTERESTED IN 698 00:33:14,926 --> 00:33:17,529 PARTICIPATING IN PROGRAMS SUCH 699 00:33:17,529 --> 00:33:21,833 AS A ONE THAT CHRISTINE 700 00:33:21,833 --> 00:33:26,538 DESCRIBED EARLIER. 701 00:33:26,538 --> 00:33:29,374 >> GREAT. THANK YOU. THIS WAS 702 00:33:29,374 --> 00:33:30,475 REALLY INTERESTING PERSPECTIVE. 703 00:33:30,475 --> 00:33:33,345 YOU KNOW, I DO WANT TO SAY THAT 704 00:33:33,345 --> 00:33:36,648 SOMETIMES YOU MENTIONED THAT -- 705 00:33:36,648 --> 00:33:39,517 THAT YOUR COMPANY MAY HAVE FEWER 706 00:33:39,517 --> 00:33:42,821 PEOPLE THAN DRUGS AND WAS 707 00:33:42,821 --> 00:33:47,893 IMPRESSED BY PLENARY SPEAKERS 708 00:33:47,893 --> 00:33:50,762 WHO MANAGED TO BRING DRUG TO FDA 709 00:33:50,762 --> 00:33:53,031 APPROVAL WITH MINIMAL STAFFING; 710 00:33:53,031 --> 00:33:53,498 RIGHT? 711 00:33:53,498 --> 00:34:00,238 ONE OF THOSE PEOPLE THAT I 712 00:34:00,238 --> 00:34:04,976 TOTALLY ADMIRE IS NEXT SPEAKER 713 00:34:04,976 --> 00:34:08,547 RAPHAELA WITH, YOU KNOW, A SMALL 714 00:34:08,547 --> 00:34:10,749 GROUP WITH DRAGS FOR FDA 715 00:34:10,749 --> 00:34:14,085 APPROVALS FOR PATIENTS AND 716 00:34:14,085 --> 00:34:14,920 RAPHAELA, PLEASE. 717 00:34:14,920 --> 00:34:25,430 >> THANK YOU VERY MUCH DEDETO 718 00:34:26,498 --> 00:34:28,733 THIS PANEL AND MEETING AND 719 00:34:28,733 --> 00:34:29,801 VIOLATING A LITTLE BIT 720 00:34:29,801 --> 00:34:31,269 CONVENTION THAT I HAVE SLIDES 721 00:34:31,269 --> 00:34:33,171 THAT I HOPE THAT THESE WILL 722 00:34:33,171 --> 00:34:34,773 ACTUALLY HELP TO TELL THE STORY 723 00:34:34,773 --> 00:34:36,441 I WANT TO TELL YOU. 724 00:34:36,441 --> 00:34:46,985 LET ME SEE IF I CAN SHARE THIS. 725 00:34:48,353 --> 00:34:50,388 WHAT YOU SEE IS THE CLINICAL 726 00:34:50,388 --> 00:34:52,557 CENTER AND HOPE YOU SEE THIS 727 00:34:52,557 --> 00:34:53,825 WITH TRANSLATIONAL RESEARCH 728 00:34:53,825 --> 00:34:57,128 CURSE AND I'M CHIEF OF THE 729 00:34:57,128 --> 00:34:59,931 TRANSLATIONAL AUTO INFLAMMATORY 730 00:34:59,931 --> 00:35:01,266 TRANSLATION SECTION AND 731 00:35:01,266 --> 00:35:02,400 RHEUMATOLOGIST IN TRANSLATIONAL 732 00:35:02,400 --> 00:35:04,469 RESEARCH AND PASSION IS TO SEE 733 00:35:04,469 --> 00:35:08,006 AND TREAT YOUNG CHILDREN AND 734 00:35:08,006 --> 00:35:12,544 ADULTS WITH RARE INFLAMMATORY 735 00:35:12,544 --> 00:35:14,646 CONDITIONS REFERRED TO US FROM 736 00:35:14,646 --> 00:35:16,047 NATIONAL AND INTERNATIONAL 737 00:35:16,047 --> 00:35:22,954 SOURCES AND PATIENTS ARE OFTEN 738 00:35:22,954 --> 00:35:25,423 TO COMMUNITIES AND NO GOOD 739 00:35:25,423 --> 00:35:26,925 TREATMENTS AND GOAL TO DISCOVER 740 00:35:26,925 --> 00:35:29,561 GENETIC CAUSE AND BY DOING SO 741 00:35:29,561 --> 00:35:34,232 IDENTIFY PATHOGENIC PATHWAYS 742 00:35:34,232 --> 00:35:36,234 BIOMARKERS ALLOWING US TO 743 00:35:36,234 --> 00:35:38,636 DEVELOP ON TREATMENT WITH 744 00:35:38,636 --> 00:35:41,473 PROTOCOLS WITH TARGETED AGENCIES 745 00:35:41,473 --> 00:35:43,575 WHEN EFFECTIVE IMPROVE LIVES OF 746 00:35:43,575 --> 00:35:45,110 CHILDREN AND UNBURDEN AND ALLOW 747 00:35:45,110 --> 00:35:48,546 THEM TO BE TREATED IN 748 00:35:48,546 --> 00:35:52,550 COMMUNITIES AND ALSO BY SEEKING 749 00:35:52,550 --> 00:35:54,853 REGULATORY APPROVAL MAKING IT 750 00:35:54,853 --> 00:35:57,288 POSSIBLE AND WE HAVE A LARGE 751 00:35:57,288 --> 00:36:01,659 COHORT OF OVER 600 PATIENTS IN 752 00:36:01,659 --> 00:36:03,128 WIDE [INDISCERNIBLE] THAT HAVE 753 00:36:03,128 --> 00:36:06,064 NOT GENETICALLY SOLVED AND CLOSE 754 00:36:06,064 --> 00:36:08,533 TO 50% AND BE ABLE TO IDENTIFY 755 00:36:08,533 --> 00:36:10,502 PATHWAYS THAT COULD BE TARGETED 756 00:36:10,502 --> 00:36:13,738 THAT BRINGS US TO NEXT PROBLEM. 757 00:36:13,738 --> 00:36:16,808 WE ARE ABLE TO UNCOVER 758 00:36:16,808 --> 00:36:20,311 PARTICULAR REGIONS USING EX-HOME 759 00:36:20,311 --> 00:36:22,881 AND WHOLE GENOME SEQUENCES IN 760 00:36:22,881 --> 00:36:24,983 2011 AND CAUSES MANY ARE 761 00:36:24,983 --> 00:36:26,818 [INDISCERNIBLE] IN PATIENTS WITH 762 00:36:26,818 --> 00:36:29,387 AUTO INFLAMMATORY PHENOTYPES AND 763 00:36:29,387 --> 00:36:30,889 HOWEVER EACH DISEASE IS RARE AND 764 00:36:30,889 --> 00:36:33,858 NO THE JUST RARE BUT ULTRA RARE. 765 00:36:33,858 --> 00:36:35,694 MOST CONDITIONS SHOWN HERE HAVE 766 00:36:35,694 --> 00:36:40,065 A PREVALENCE OF LESS THAN 320 IN 767 00:36:40,065 --> 00:36:44,736 THE UNITED STATES OF LESS THAN A 768 00:36:44,736 --> 00:36:47,839 MILLION AND 550 PATIENTS THAT 769 00:36:47,839 --> 00:36:49,541 WILL BE WORLDWIDE WITH A 770 00:36:49,541 --> 00:36:50,975 PARTICULAR DISEASE AND WELL 771 00:36:50,975 --> 00:36:54,479 DEFINED PATHWAYS GIVING IDEAS 772 00:36:54,479 --> 00:36:57,015 WHERE TO TREAT MANY IMMUNE 773 00:36:57,015 --> 00:37:01,853 CYTOKINES THAT IS INTERFERON 774 00:37:01,853 --> 00:37:05,523 IL18 AND HYPOACTIVATION AND 775 00:37:05,523 --> 00:37:06,691 MODIFIERS OF AUTO IMMUNE 776 00:37:06,691 --> 00:37:08,560 RESPONSES AND PATIENTS ARE 777 00:37:08,560 --> 00:37:11,596 SPREAD THROUGHOUT THE WORLD AND 778 00:37:11,596 --> 00:37:13,231 WE HAVE INCREDIBLE OPPORTUNITY 779 00:37:13,231 --> 00:37:15,333 TO RECRUIT THEM AND FORM COHORTS 780 00:37:15,333 --> 00:37:19,070 OF PATIENTS NEEDED TO MAKE 781 00:37:19,070 --> 00:37:20,905 CLINICAL OBSERVATIONS PHENOTYPE 782 00:37:20,905 --> 00:37:23,675 OF DISEASE AND DO BASICALLY 783 00:37:23,675 --> 00:37:25,043 TREATMENTS AND HOWEVER OUT OF 784 00:37:25,043 --> 00:37:31,716 THE 73 GENETICALLY DEFINED AUTO 785 00:37:31,716 --> 00:37:32,617 INFLAMMATORY DISEASES SYSTEMIC 786 00:37:32,617 --> 00:37:34,853 WE HAVE DRUGS APPROVED FOR FIVE 787 00:37:34,853 --> 00:37:38,389 OF THOSE DISEASES AND ABILITY TO 788 00:37:38,389 --> 00:37:40,592 DISCOVER THOSE DISEASES FAR 789 00:37:40,592 --> 00:37:42,360 OUTSPACES OUR ABILITY TO APPROVE 790 00:37:42,360 --> 00:37:44,229 TREATMENTS BASICALLY. 791 00:37:44,229 --> 00:37:47,298 TREATMENT IS IMPORTANT. 792 00:37:47,298 --> 00:37:49,300 PATIENTS PRESENT WITH SYSTEMIC 793 00:37:49,300 --> 00:37:53,204 AND ORGAN INFLAMMATION THAT 794 00:37:53,204 --> 00:37:55,807 LEADS TO RAPID DEVELOPMENT AND 795 00:37:55,807 --> 00:37:57,876 PROGRESSION OF ORGAN DAMAGE 796 00:37:57,876 --> 00:38:00,578 DISABILITY AND MORTALITY FOR 797 00:38:00,578 --> 00:38:04,916 MANY DISEASES IS AROUND 30% IN 798 00:38:04,916 --> 00:38:06,684 ADOLESCENTS BEFORE THEY HIT 799 00:38:06,684 --> 00:38:08,219 CHILDHOOD AND ORGAN DAMAGE 800 00:38:08,219 --> 00:38:10,121 EFFECTS ORGANS WE SEE HERE AND 801 00:38:10,121 --> 00:38:11,589 TREATMENT APPROACHES ARE 802 00:38:11,589 --> 00:38:15,426 CURRENTLY TARGETED TO BLOCK 803 00:38:15,426 --> 00:38:15,760 INFLAMMATION. 804 00:38:15,760 --> 00:38:18,296 THERE ARE GREAT OPPORTUNITIES TO 805 00:38:18,296 --> 00:38:21,833 ACTUALLY IN THE FUTURE POSSESS 806 00:38:21,833 --> 00:38:24,135 DRUGS EFFECTING PATHWAYS WITH 807 00:38:24,135 --> 00:38:26,938 IMPACT ON TISSUE DIFFERENTIATION 808 00:38:26,938 --> 00:38:28,506 THAT DERIVE ORGAN DAMAGE. 809 00:38:28,506 --> 00:38:31,643 I WAS ASKED BY DEDETO TELL YOU 810 00:38:31,643 --> 00:38:33,778 ABOUT TWO SUCCESS STORIES OF 811 00:38:33,778 --> 00:38:35,880 GETTING DRUGS APPROVED FOR TWO 812 00:38:35,880 --> 00:38:39,350 RARE DISEASES THAT I HAVE -- 813 00:38:39,350 --> 00:38:43,955 THAT I HAVE HEADED OR HAVE LED. 814 00:38:43,955 --> 00:38:45,723 ALSO, TO BASICALLY POINT TO THE 815 00:38:45,723 --> 00:38:48,660 BUMPS THAT WE HAVE. THE FIRST 816 00:38:48,660 --> 00:38:52,597 DISEASE IS ACTUALLY A DISEASE 817 00:38:52,597 --> 00:38:54,933 THAT IS NEONATAL ONSET SYSTEM 818 00:38:54,933 --> 00:38:58,736 DISEASE THAT I HAVE BEEN 819 00:38:58,736 --> 00:38:59,337 STUDYING AND HAVE 820 00:38:59,337 --> 00:39:01,339 [INDISCERNIBLE] OF IN 2000 AND 821 00:39:01,339 --> 00:39:03,441 HAVE IDENTIFIED THE GENETIC 822 00:39:03,441 --> 00:39:05,710 CAUSE FOR FAMILIAL DISEASE THAT 823 00:39:05,710 --> 00:39:07,445 PRESENTS WITH CODE INDUCED 824 00:39:07,445 --> 00:39:09,781 FEVERS AND NEUTROPHILIC 825 00:39:09,781 --> 00:39:11,482 DECARRIER AND IN TWO YEARS WE 826 00:39:11,482 --> 00:39:15,053 USED ACTUALLY GENE AND SEARCH 827 00:39:15,053 --> 00:39:17,855 PRIOR TO EX-HOME GENOME 828 00:39:17,855 --> 00:39:20,458 SEQUENCING TARGETED APPROACH AND 829 00:39:20,458 --> 00:39:22,894 SEVERE PHENOTYPE THAT PRESENTED 830 00:39:22,894 --> 00:39:25,730 WITH FEVER AND NEUTROPHILIC 831 00:39:25,730 --> 00:39:31,536 CARRIER AND LED TO RAPID 832 00:39:31,536 --> 00:39:32,403 PROGRESSION PRESENTED WITH 833 00:39:32,403 --> 00:39:34,672 ANJIETS AND HEARING LOSS AVEND 834 00:39:34,672 --> 00:39:37,342 MUSCULAR DISTROPHY AND FINDING 835 00:39:37,342 --> 00:39:40,078 OF MUTATION AT THAT TIME 836 00:39:40,078 --> 00:39:41,179 COINCIDED WITH DISCOVERY THAT 837 00:39:41,179 --> 00:39:44,282 THIS MOLECULE IS ASSOCIATED WITH 838 00:39:44,282 --> 00:39:48,186 IL1 ACTIVATING PATHWAY THAT IS 839 00:39:48,186 --> 00:39:49,821 INFLAMOSOME AND RAISED QUESTION 840 00:39:49,821 --> 00:39:52,590 WHERE I1 IS DRIVING A MAJOR 841 00:39:52,590 --> 00:39:54,425 COMPONENT OF DISEASE PHENOTYPE 842 00:39:54,425 --> 00:39:57,829 WE SEE IN THOSE PATIENTS AND 843 00:39:57,829 --> 00:39:59,864 RARER DISEASE AFTER THAT, WE 844 00:39:59,864 --> 00:40:01,532 IDENTIFIED LOSS OF FUNCTION 845 00:40:01,532 --> 00:40:03,901 MUTATIONS AND PATIENTS 846 00:40:03,901 --> 00:40:06,938 PRESENTING WITH PUFTULA SKIN 847 00:40:06,938 --> 00:40:10,108 LESIONS AND AFTO MILITIS AND 848 00:40:10,108 --> 00:40:14,913 LACK OF IL1 RECEPTOR ANTAGONIST 849 00:40:14,913 --> 00:40:18,216 MADE INTO RECOMBINANT MEDICATION 850 00:40:18,216 --> 00:40:21,352 SOLD AND MARKETED AND THAT DRUG 851 00:40:21,352 --> 00:40:23,388 HAS BEEN AVAILABLE AND LED TO 852 00:40:23,388 --> 00:40:25,590 THE DEVELOPMENT OF TRANSLATIONAL 853 00:40:25,590 --> 00:40:28,226 STUDY USING [INDISCERNIBLE] 854 00:40:28,226 --> 00:40:31,195 RECOMBINANT IL1 RECEPTOR 855 00:40:31,195 --> 00:40:33,698 ANTAGONIST TO TREAT PATIENTS 856 00:40:33,698 --> 00:40:38,202 WITH NO. NOMAD AND MAJOR 857 00:40:38,202 --> 00:40:39,671 RESPONSES WE HAVE SEEN MADE 858 00:40:39,671 --> 00:40:42,240 CLEAR THAT IL1 HAD A MAJOR ROLE 859 00:40:42,240 --> 00:40:44,042 IN THAT AND WROTE A 860 00:40:44,042 --> 00:40:45,810 TRANSLATIONAL PROTOCOL AND AT 861 00:40:45,810 --> 00:40:49,614 THAT TIME NEGOTIATIONS WITH MGEN 862 00:40:49,614 --> 00:40:52,083 WHO MARKETED MEDICATION APPROVED 863 00:40:52,083 --> 00:40:55,953 FOR TREATMENT OF RHEUMATOID 864 00:40:55,953 --> 00:40:57,722 ARTHRITIS FAILED APPROVAL INCEP 865 00:40:57,722 --> 00:41:00,091 SIS AND INTELLECTUAL PROPERTY 866 00:41:00,091 --> 00:41:03,094 RIGHTS IT COULD NT BE SIGNED AND 867 00:41:03,094 --> 00:41:07,799 COULD CO-REFERENCE IND AND NIH 868 00:41:07,799 --> 00:41:11,502 PHARMACY AGREED TO PURCHASING 869 00:41:11,502 --> 00:41:13,971 AKINRA. WE WERE ABLE TO CONDUCT 870 00:41:13,971 --> 00:41:15,506 STUDY AND DO OBSERVATIONS BUT 871 00:41:15,506 --> 00:41:17,375 NOT WITH SUPPORT THAT WE 872 00:41:17,375 --> 00:41:19,777 INITIALLY HOPED TO GET AND HAD 873 00:41:19,777 --> 00:41:23,014 TO GENERATE ACCESS DATA BASE 874 00:41:23,014 --> 00:41:24,482 BECAUSE CASE REPORT FORMS COULD 875 00:41:24,482 --> 00:41:27,185 NT BE ENTERED INTO COMPANY DATA 876 00:41:27,185 --> 00:41:31,022 BASE THAT WE INITIALLY ACTUALLY 877 00:41:31,022 --> 00:41:33,491 HOPED FOR. 878 00:41:33,491 --> 00:41:35,593 IT WASN'T AVAILABLE. 879 00:41:35,593 --> 00:41:38,796 ROAD GOT BUMPIER AND GOT TO FDA 880 00:41:38,796 --> 00:41:40,598 APPROVAL AFTER 10 YEARS AND 881 00:41:40,598 --> 00:41:43,234 THERE WERE SEVERAL 882 00:41:43,234 --> 00:41:43,601 MODIFICATIONS. 883 00:41:43,601 --> 00:41:44,902 AND SEVERAL HEADACHES. 884 00:41:44,902 --> 00:41:46,971 AFTER THE DRUG HAD BEEN VERY 885 00:41:46,971 --> 00:41:49,974 BENEFICIAL TO PATIENTS, PARENTS 886 00:41:49,974 --> 00:41:51,676 GOT VERY CONCERNED ABOUT 887 00:41:51,676 --> 00:41:52,577 CONTINUED ACCESS AND 888 00:41:52,577 --> 00:41:54,579 PARTICULARLY IN THE CONTEXT WHEN 889 00:41:54,579 --> 00:41:59,217 RIGHTS OF AKIN RA WAS SOLD TO 890 00:41:59,217 --> 00:42:02,754 SOBY IN 2008 AND NO INDICATION 891 00:42:02,754 --> 00:42:04,389 FOR INCREASING INDICATION OF 892 00:42:04,389 --> 00:42:05,723 OBTAINING APPROVAL AND WHAT IS 893 00:42:05,723 --> 00:42:07,258 HEARD AND IF TOLD IF DRUG IS 894 00:42:07,258 --> 00:42:09,794 ALREADY APPROVED WHY NOT GET IT 895 00:42:09,794 --> 00:42:13,197 OFF LABEL? 896 00:42:13,197 --> 00:42:15,566 FAMILY OF ORGANIZATION OR AUTO 897 00:42:15,566 --> 00:42:19,203 INFLAMMATORY ALLIANCE CONDUCTED 898 00:42:19,203 --> 00:42:21,305 STUDY TO ASK WHICH PATIENTS BY 899 00:42:21,305 --> 00:42:24,575 2008 WERE ABLE TO GET THE DRUG 900 00:42:24,575 --> 00:42:25,743 THROUGH INSURANCE THAT IS LESS 901 00:42:25,743 --> 00:42:28,045 THAN 50% WERE ABLE TO GET DRUG 902 00:42:28,045 --> 00:42:30,948 THROUGH INSURANCE AND EXTENDED 903 00:42:30,948 --> 00:42:32,884 STUDY MULTIPLE TIMES TO SUPPLY 904 00:42:32,884 --> 00:42:36,587 DRUG FOR PATIENTS AND WERE ABLE 905 00:42:36,587 --> 00:42:40,458 TO GENERATE A CREEDA WITH SOBY 906 00:42:40,458 --> 00:42:42,660 AND SOME RIGHTS AND RESTRICTIONS 907 00:42:42,660 --> 00:42:45,530 AND PATENT OR LICENSE WAS 908 00:42:45,530 --> 00:42:48,966 TRANSFERRED OR REMOVED AND BASED 909 00:42:48,966 --> 00:42:54,105 ON CONTINUED PUSHING FROM THE 910 00:42:54,105 --> 00:42:56,774 FAMILY ORGANIZATION THAT WROTE 911 00:42:56,774 --> 00:43:00,978 LETTERS AND SOBY AGREED TO 912 00:43:00,978 --> 00:43:03,281 FILING AN OR FAN DESIGNATION TO 913 00:43:03,281 --> 00:43:05,483 AKIN RA AND SUPPORT THE 914 00:43:05,483 --> 00:43:10,188 SUBMISSION OF THE DATA THAT WE 915 00:43:10,188 --> 00:43:16,260 ACTUALLY HAD COLLECTED AND THAT, 916 00:43:16,260 --> 00:43:19,864 AGAIN, WBUMPY AGAIN AND FDA AND 917 00:43:19,864 --> 00:43:21,732 SOBY FILED APPLICATION SPENT 918 00:43:21,732 --> 00:43:23,801 MONTHS AT NIH CLEANING DATA 919 00:43:23,801 --> 00:43:26,204 GETTING IT IN DATABASE THAT 920 00:43:26,204 --> 00:43:28,406 WOULD BE ACCEPTABLE FOR 921 00:43:28,406 --> 00:43:30,975 REGULATORY ADMISSION AND FALL OF 922 00:43:30,975 --> 00:43:33,978 2011 FAILED AND FDA FELT THAT WE 923 00:43:33,978 --> 00:43:37,148 NEEDED A RANDOMIZED CONTROL 924 00:43:37,148 --> 00:43:40,351 STUDY TO APPROVE EFFICACY THAT 925 00:43:40,351 --> 00:43:43,454 LED TO AN AN APPEAL BY THE 926 00:43:43,454 --> 00:43:45,957 COMPANY AND FDA INVITED THE 927 00:43:45,957 --> 00:43:48,125 PANEL THAT CONSISTED OF EXPERTS 928 00:43:48,125 --> 00:43:50,795 IN THE FIELD AS WELL AS PATIENTS 929 00:43:50,795 --> 00:43:55,032 AND PARENTS AND AFTER THAT, 930 00:43:55,032 --> 00:43:58,769 DECIDED ON THE FACT THAT OUR 931 00:43:58,769 --> 00:44:02,039 DATA WAS SIGNIFICANT AND WAS 932 00:44:02,039 --> 00:44:03,608 SUFFICIENT FOR APPROVAL THAT 933 00:44:03,608 --> 00:44:05,343 RESTED ON FACT THAT WE HAD 934 00:44:05,343 --> 00:44:08,746 CONVERTED A RANDOMIZED CONTROL 935 00:44:08,746 --> 00:44:11,916 STUDY THAT WE COULDN'T DO WITH 936 00:44:11,916 --> 00:44:14,418 ADDING AN OPEN LABEL WITHDRAWAL 937 00:44:14,418 --> 00:44:16,454 STUDY FOR PATIENTS. 938 00:44:16,454 --> 00:44:18,322 WHAT WE SAW WAS WITHIN THREE 939 00:44:18,322 --> 00:44:21,526 MONTHS PATIENTS NORMALIZE THEIR 940 00:44:21,526 --> 00:44:24,862 SYMPTOMS AND INFLAMMATORY 941 00:44:24,862 --> 00:44:25,429 MARKERS. 942 00:44:25,429 --> 00:44:27,665 WHEN WE WITHDREW PATIENTS AFTER 943 00:44:27,665 --> 00:44:29,467 THREE MONTHS AND 2 TO 5 DAYS 944 00:44:29,467 --> 00:44:31,435 THEY HAD REBOUND FLAIRS AND 945 00:44:31,435 --> 00:44:34,238 SYMPTOMS REOCCURRED AND 946 00:44:34,238 --> 00:44:35,172 INFLAMMATORY MARKERS WERE HIGHER 947 00:44:35,172 --> 00:44:36,908 THAN THEY WERE AT BASELINE AND 948 00:44:36,908 --> 00:44:39,911 WE WERE WORRIED ABOUT PERMANENT 949 00:44:39,911 --> 00:44:41,746 ORGAN DAMAGE AND STOPPED THE 950 00:44:41,746 --> 00:44:43,714 TRIAL OR ARM OF THE STUDY THAT 951 00:44:43,714 --> 00:44:46,350 IS BEING NOT ETHICALLY 952 00:44:46,350 --> 00:44:48,853 SUPPORTABLE AFTER 11 PATIENTS 953 00:44:48,853 --> 00:44:50,354 HAD BEEN WITHDRAWN. 954 00:44:50,354 --> 00:44:52,823 THAT COMPONENT WAS LATER DECIDED 955 00:44:52,823 --> 00:44:55,359 TO BE UNETHICAL GIVEN SEVERITY 956 00:44:55,359 --> 00:44:56,794 OF THIS DISEASE THAT ACTUALLY 957 00:44:56,794 --> 00:45:00,331 ALLOWED THE APPROVAL OF THE 958 00:45:00,331 --> 00:45:03,901 STUDY AND APPROVAL OF THE DATA 959 00:45:03,901 --> 00:45:07,438 AND MADE A HUGE DIFFERENCE IN 960 00:45:07,438 --> 00:45:09,674 FACT TO CHILDREN WITH THIS 961 00:45:09,674 --> 00:45:10,074 DISEASE. 962 00:45:10,074 --> 00:45:12,476 NOW THEY WEREN'T IN FACT ABLE TO 963 00:45:12,476 --> 00:45:16,414 OBTAIN THE DRUG THROUGH THE 964 00:45:16,414 --> 00:45:16,847 INSURANCE. 965 00:45:16,847 --> 00:45:20,585 AND THE -- ALTHOUGH AKINRA WAS 966 00:45:20,585 --> 00:45:24,522 REPURPOSED IT WAS APPROVED FOR 967 00:45:24,522 --> 00:45:25,056 RHEUMATOID ARTHRITIS AND 968 00:45:25,056 --> 00:45:27,391 [INDISCERNIBLE] TO OTHER 969 00:45:27,391 --> 00:45:29,727 STRATEGIES TO PLOT IL1 970 00:45:29,727 --> 00:45:34,699 RECOMBINANT IL1 RECEPTOR AND 971 00:45:34,699 --> 00:45:36,601 ANTIBODY FOR BETA WE WERE 972 00:45:36,601 --> 00:45:39,203 AVAILABLE AND NOT APPROVED IN 973 00:45:39,203 --> 00:45:41,038 CONTEXT OF AGENTS BEING 974 00:45:41,038 --> 00:45:44,408 SUCCESSFUL AND COMPANIES 975 00:45:44,408 --> 00:45:46,077 ACTUALLY ADDRESSED US AND GOT 976 00:45:46,077 --> 00:45:49,180 RARE OR FIRST APPROVAL IN A RARE 977 00:45:49,180 --> 00:45:51,415 DISEASE THAT IS UNUSUAL TO 978 00:45:51,415 --> 00:45:54,385 OBTAIN DRUG FOR PATIENTS WITH 979 00:45:54,385 --> 00:45:57,321 RARE DISEASES WITHOUT APPROVAL 980 00:45:57,321 --> 00:46:00,224 AS YOU HAVE HEARD IS A CONSTANT 981 00:46:00,224 --> 00:46:02,493 BATTLE AND WORKS SOMETIMES AND 982 00:46:02,493 --> 00:46:04,795 ALLOWED US TO ACTUALLY CONSIDER 983 00:46:04,795 --> 00:46:15,339 [INDISCERNIBLE] A LONGER ACTING 984 00:46:16,107 --> 00:46:19,143 IL1 INHIBITOR FOR SECOND 985 00:46:19,143 --> 00:46:19,410 DISEASE. 986 00:46:19,410 --> 00:46:24,615 WE CONVINCED INITIATOR STUDY 987 00:46:24,615 --> 00:46:28,285 SUPPORTED DRUG AT BEGINNING TO 988 00:46:28,285 --> 00:46:30,421 TREAT PATIENTS WHO BASICALLY HAD 989 00:46:30,421 --> 00:46:34,659 BEEN TREATED WITH ANAKINRA AND 990 00:46:34,659 --> 00:46:36,927 FDA HEARING PRESENTATION ABOUT 991 00:46:36,927 --> 00:46:39,196 DISEASES THAT ENCOURAGED 992 00:46:39,196 --> 00:46:40,431 REGENERAL RANT TO FILE A 993 00:46:40,431 --> 00:46:43,868 SUPPLEMENT ALIBI LOGICAL LICENSE 994 00:46:43,868 --> 00:46:46,137 APPLICATION FOR RELONO CREPT FOR 995 00:46:46,137 --> 00:46:48,305 INDICATION DIRA THAT CONSIDERED 996 00:46:48,305 --> 00:46:51,542 AND ACTUALLY AFTER A BRIEFING 997 00:46:51,542 --> 00:46:54,679 DOCUMENT WITH FDA AND FOUND THAT 998 00:46:54,679 --> 00:46:57,014 ALL PATIENTS PREVIOUSLY HAD BEEN 999 00:46:57,014 --> 00:47:02,219 TREATED WITH ANAKINRA WOULD 1000 00:47:02,219 --> 00:47:06,957 CONSIDER CO-FILING TO INDUCE 1001 00:47:06,957 --> 00:47:07,958 REMISSION AND [INDISCERNIBLE] TO 1002 00:47:07,958 --> 00:47:10,027 MAINTAIN REMISSION IN DISEASE 1003 00:47:10,027 --> 00:47:13,597 WHERE WE HAD LITERALLY AGAIN AN 1004 00:47:13,597 --> 00:47:15,633 AMAZING RESPONSE TO TREATMENT 1005 00:47:15,633 --> 00:47:17,802 AND PATIENTS WERE ACTUALLY 1006 00:47:17,802 --> 00:47:20,771 LACKING OR MAKING PROTEIN IL1 1007 00:47:20,771 --> 00:47:24,341 RECEPTOR ANTAGONIST THAT AKINRA 1008 00:47:24,341 --> 00:47:26,944 WAS A REPLACEMENT AND TREATMENT 1009 00:47:26,944 --> 00:47:33,451 WITH RELONOCEPT WORKED WITH 1010 00:47:33,451 --> 00:47:36,587 DAILY INJECTIONS THAT ARE 1011 00:47:36,587 --> 00:47:38,522 PAINFUL AND CHALLENGING FOR 1012 00:47:38,522 --> 00:47:40,024 PATIENTS AND TOOK A WHILE TO 1013 00:47:40,024 --> 00:47:43,160 DWET SOBY TO CONVINCE TO FILE 1014 00:47:43,160 --> 00:47:45,596 FOR A RARE DISEASE AND NIH AND 1015 00:47:45,596 --> 00:47:48,966 ACTUALLY DIET ALLOWED ME TO HIRE 1016 00:47:48,966 --> 00:47:51,702 A ZERO TO CLEAN DATA THAT WAS 1017 00:47:51,702 --> 00:47:52,903 COLLECTED ON A NATURAL HISTORY 1018 00:47:52,903 --> 00:47:56,107 STUDY AND HAD TO BE PULLED OUT 1019 00:47:56,107 --> 00:47:59,009 RETROSPECTIVELY TO GENERATE DATA 1020 00:47:59,009 --> 00:48:01,445 CLEAN ENOUGH TO BE CONSIDERED 1021 00:48:01,445 --> 00:48:03,781 FOR REGULATORY SUBMISSION AND 1022 00:48:03,781 --> 00:48:05,816 AGREED TO FILING REGULATORY 1023 00:48:05,816 --> 00:48:07,084 COMPONENT COULDN'T BE TAKEN OVER 1024 00:48:07,084 --> 00:48:09,720 BY INVESTIGATORS HAD TO BE DONE 1025 00:48:09,720 --> 00:48:14,358 BY COMPANY AS WELL AS WRITING 1026 00:48:14,358 --> 00:48:20,064 THE LABEL AND 2020FDA APPROVES 1027 00:48:20,064 --> 00:48:21,165 ANAKINRA AND [INDISCERNIBLE] FOR 1028 00:48:21,165 --> 00:48:22,066 TREATMENT OF [INDISCERNIBLE] AND 1029 00:48:22,066 --> 00:48:25,603 AFTER 13 YEARS AND 7 YEARS OF 1030 00:48:25,603 --> 00:48:28,172 USING AN IL1 TRIAL AND ACTUALLY 1031 00:48:28,172 --> 00:48:30,474 ENROLLING PATIENTS IN THE 1032 00:48:30,474 --> 00:48:33,444 NATURAL HISTORY STUDY AND ALSO 1033 00:48:33,444 --> 00:48:37,615 SHOWED THAT DATA COLLECTED IN 1034 00:48:37,615 --> 00:48:38,883 PROSPECTIVE WAY IN NATURAL 1035 00:48:38,883 --> 00:48:41,218 HISTORY STUDY COULD BE USED FOR 1036 00:48:41,218 --> 00:48:44,989 DRUG APPROVAL BASED ON DATA IN 1037 00:48:44,989 --> 00:48:48,359 PATIENTS RECEIVING AKINRA AND 1038 00:48:48,359 --> 00:48:49,927 RECEIVED [INDISCERNIBLE] AND 1039 00:48:49,927 --> 00:48:51,695 STUDIES WERE OPEN LABELED AND 1040 00:48:51,695 --> 00:48:53,764 USING HISTORICAL DATA WE COULD 1041 00:48:53,764 --> 00:48:57,368 SHOW ALL PATIENTS BEING REPORTED 1042 00:48:57,368 --> 00:49:02,640 WITH DIRA AND RETROSPECTIVELY 1043 00:49:02,640 --> 00:49:04,942 DIAGNOSED DIDN'T SURVIVE AND 1044 00:49:04,942 --> 00:49:07,478 DIED MEDIAN YEARS AND PROLONGED 1045 00:49:07,478 --> 00:49:09,013 HOSPITALIZATION AND WE USED 1046 00:49:09,013 --> 00:49:12,416 HOSPITALIZATION DATES AS WELL AS 1047 00:49:12,416 --> 00:49:16,220 HISTORICAL DATA ON DEATH AND 1048 00:49:16,220 --> 00:49:17,788 MORTALITY TO F- ACTUALLY GET 1049 00:49:17,788 --> 00:49:19,924 OPEN LABEL DRUG APPROVED AND 1050 00:49:19,924 --> 00:49:22,827 WERE LESS SUCCESSFUL WITH 1051 00:49:22,827 --> 00:49:24,862 ANOTHER CONDITION THAT WE 1052 00:49:24,862 --> 00:49:28,265 IDENTIFIED IN 2011 AND LOSS OF 1053 00:49:28,265 --> 00:49:30,835 FUNCTION MUTATIONS IN 1054 00:49:30,835 --> 00:49:31,936 PROETEOSOME CAUSE INFLAMMATORY 1055 00:49:31,936 --> 00:49:35,439 DISEASE PRESENTING WITH 1056 00:49:35,439 --> 00:49:37,875 NEUTROPHILIC PANNO CHOELITIS AND 1057 00:49:37,875 --> 00:49:40,744 FAT WITH METABOLIC SYNDROME AND 1058 00:49:40,744 --> 00:49:43,347 PATIENTS HAD STRONG INTERFERON 1059 00:49:43,347 --> 00:49:44,682 SIGNATURE SUGGESTING THAT IT 1060 00:49:44,682 --> 00:49:46,684 MIGHT BE A LARGE DRIVER THAT IS 1061 00:49:46,684 --> 00:49:48,819 SUPPORTED BY BASIC RESEARCH 1062 00:49:48,819 --> 00:49:51,455 FINDINGS IN DRIVING DISEASE 1063 00:49:51,455 --> 00:49:57,561 MANIFESTATIONS AND IN 2011, 1064 00:49:57,561 --> 00:50:00,464 MARKETED BY ASTROZEN EBBINGA WAS 1065 00:50:00,464 --> 00:50:03,000 ON THE MARKET. WEREN'T TO 1066 00:50:03,000 --> 00:50:04,201 DEVELOP OR OBTAIN THAT. 1067 00:50:04,201 --> 00:50:06,136 WASN'T APPROVED FOR THE DISEASE. 1068 00:50:06,136 --> 00:50:08,772 IT WAS ACTUALLY IN TRIALS FOR 1069 00:50:08,772 --> 00:50:11,609 LUPUS AND BECAUSE THE DISEASE 1070 00:50:11,609 --> 00:50:13,077 WAS QUITE SIGNIFICANT AND 1071 00:50:13,077 --> 00:50:20,584 ACTUALLY CAUSES SEVERE GROWTH 1072 00:50:20,584 --> 00:50:22,253 RETARDATION IN CHILDREN AND 1073 00:50:22,253 --> 00:50:24,455 BLOCKING INTERFERON SIGNALING 1074 00:50:24,455 --> 00:50:26,757 FROM LILY DRUG WAS NOT APPROVED 1075 00:50:26,757 --> 00:50:28,659 AT THAT TIME FOR RHEUMATOID 1076 00:50:28,659 --> 00:50:31,862 ARTHRITIS AND THEY MADE IT 1077 00:50:31,862 --> 00:50:32,263 AVAILABLE. 1078 00:50:32,263 --> 00:50:34,598 THIS WAS LUCKY AND TREATMENT 1079 00:50:34,598 --> 00:50:35,933 IMPROVED DISEASE SIGNIFICANTLY 1080 00:50:35,933 --> 00:50:39,803 AND LED TO COMPLETE REMISSION OF 1081 00:50:39,803 --> 00:50:42,840 STEROIDS IN 50% OF PATIENTS 1082 00:50:42,840 --> 00:50:45,643 DEVELOPING BIOMARKET TO QUANTIFY 1083 00:50:45,643 --> 00:50:48,579 MEASURING INTERFERON SIGNALING 1084 00:50:48,579 --> 00:50:51,548 NORMALIZING 50% OF PATIENTS WITH 1085 00:50:51,548 --> 00:50:53,984 CANDLE LONG TERM AND AFTER 1086 00:50:53,984 --> 00:50:56,987 ENCOURAGING APPROVAL OF DRUG FDA 1087 00:50:56,987 --> 00:51:00,791 DECIDED IN 2021 NOT TO APPROVE 1088 00:51:00,791 --> 00:51:04,261 THE OPEN LABEL DATA STUDY WAS 1089 00:51:04,261 --> 00:51:07,197 EXPANDED IN ACCESS PROTOCOL AND 1090 00:51:07,197 --> 00:51:11,001 EXPANDED IN NOVEL DISEASES LATER 1091 00:51:11,001 --> 00:51:12,670 AND AS SUGGESTION WAS THAT WE 1092 00:51:12,670 --> 00:51:16,140 HAD INSUFFICIENT DATA TO SUPPORT 1093 00:51:16,140 --> 00:51:19,677 OR INADEQUATE DATA TO SUPPORT 1094 00:51:19,677 --> 00:51:21,879 RISK BENEFIT RATIO AND WE NEEDED 1095 00:51:21,879 --> 00:51:24,148 HIGHER DOSES THAT HAD BEEN USED 1096 00:51:24,148 --> 00:51:27,151 OR HIGHER EXPOSURE THAN ACTUALLY 1097 00:51:27,151 --> 00:51:31,221 HAD BEEN USED FOR RHEUMATOID 1098 00:51:31,221 --> 00:51:33,791 ARTHRITIS AND CONCERNS ABOUT 1099 00:51:33,791 --> 00:51:35,793 SIDE-EFFECTS AND TREATMENT IS 1100 00:51:35,793 --> 00:51:37,561 APPROVED OR RECOMMENDED BY 1101 00:51:37,561 --> 00:51:39,463 EXPERTS THAT IS ONLY AVAILABLE 1102 00:51:39,463 --> 00:51:42,299 TREATMENT MAKING MAJOR IMPACT ON 1103 00:51:42,299 --> 00:51:43,467 THIS OTHER RARE DISEASE. 1104 00:51:43,467 --> 00:51:48,439 WE NEED TO BASICALLY OBTAIN IT 1105 00:51:48,439 --> 00:51:50,741 OFF LABEL. 1106 00:51:50,741 --> 00:51:53,844 SO, I THINK I HAVE BEEN TRYING 1107 00:51:53,844 --> 00:51:55,713 TO SHOW THAT WE CAN MAKE 1108 00:51:55,713 --> 00:51:56,280 DIFFERENCES. 1109 00:51:56,280 --> 00:51:59,650 THESE DISEASES ARE OFTEN MODELS 1110 00:51:59,650 --> 00:52:03,253 FOR DRUG DEVELOPMENT AND PATHWAY 1111 00:52:03,253 --> 00:52:05,823 IS DEFINED AND IS VERY SPECIFIC 1112 00:52:05,823 --> 00:52:08,258 AND CLINICAL DISEASE 1113 00:52:08,258 --> 00:52:10,160 MANIFESTATIONS OR ORGAN 1114 00:52:10,160 --> 00:52:11,362 MANIFESTATIONS ARE DISEASE 1115 00:52:11,362 --> 00:52:12,997 SPECIFIC AND TARGETED TREATMENTS 1116 00:52:12,997 --> 00:52:15,065 USING CONDITIONS ALLOW FOR PROOF 1117 00:52:15,065 --> 00:52:18,102 OF MECHANISM AND VALIDATION OF 1118 00:52:18,102 --> 00:52:20,070 BIOMARKERS OPTIMIZING DOSING AND 1119 00:52:20,070 --> 00:52:22,406 IN FACT WE CAN ENROLL PATIENTS 1120 00:52:22,406 --> 00:52:25,009 OR CONTINUE TO ACTUALLY SEE THEM 1121 00:52:25,009 --> 00:52:28,212 EITHER LONG-TERM OR ENROLL THEM 1122 00:52:28,212 --> 00:52:29,513 BACK ON NATURAL HISTORY STUDY 1123 00:52:29,513 --> 00:52:32,282 AND LOOK AT IMPACT OF 1124 00:52:32,282 --> 00:52:34,351 MODIFICATIONS OF ORGAN DAMAGE 1125 00:52:34,351 --> 00:52:36,587 LONG-TERM AND PROVIDE PROOF OF 1126 00:52:36,587 --> 00:52:38,722 CONCEPT THAT BLOCKING A SPECIFIC 1127 00:52:38,722 --> 00:52:42,159 MECHANISM HAS AN IMPACT ON 1128 00:52:42,159 --> 00:52:45,095 DISEASE MANIFESTATIONS AND WE 1129 00:52:45,095 --> 00:52:47,331 HAVE TO CHANGE TRAJECTORY OF 1130 00:52:47,331 --> 00:52:51,101 DRUG APPROVALS OF ULTRA RARE 1131 00:52:51,101 --> 00:52:54,104 DISEASES MAKING IT FASTER AND 1132 00:52:54,104 --> 00:52:56,106 CHALLENGES TO TACKLE AND 1133 00:52:56,106 --> 00:52:58,008 PARTNERSHIPS WITH FDA AND 1134 00:52:58,008 --> 00:53:07,484 PRIVATE SECTORS AND PHARMA-AND 1135 00:53:07,484 --> 00:53:11,321 NIH WILL GET US TO TEARING DOWN 1136 00:53:11,321 --> 00:53:12,856 BARRIERS RISK AVERSION BY 1137 00:53:12,856 --> 00:53:14,124 PHARMACEUTICAL COMPANIES TO MAKE 1138 00:53:14,124 --> 00:53:16,493 DRUGS AVAILABLE FOR PATIENTS 1139 00:53:16,493 --> 00:53:18,696 WITH RARE DISEASES AND 1140 00:53:18,696 --> 00:53:20,164 TRADITIONAL HAVE NO GOOD FILE 1141 00:53:20,164 --> 00:53:22,900 DESIGN TRADITIONAL DESIGNS 1142 00:53:22,900 --> 00:53:24,234 WORKING THROUGH FOUR PHASES 1143 00:53:24,234 --> 00:53:26,770 DON'T WORK AND PARTICULARLY NOT 1144 00:53:26,770 --> 00:53:28,205 ULTRA RARE DISEASES 1145 00:53:28,205 --> 00:53:29,707 RANDOMIZATION IS NOT POSSIBLE OR 1146 00:53:29,707 --> 00:53:31,075 NOT ETHICAL. 1147 00:53:31,075 --> 00:53:33,444 WE HAVE TO WORK WITH REGULATORY 1148 00:53:33,444 --> 00:53:35,446 AGENCIES TO DEFINE OUTCOMES THAT 1149 00:53:35,446 --> 00:53:38,882 COULD BE RECOGNIZED FOR 1150 00:53:38,882 --> 00:53:40,184 REGULATORY APPROVAL. 1151 00:53:40,184 --> 00:53:43,654 WE HAVE TO DEFINE ECRFS AND 1152 00:53:43,654 --> 00:53:46,123 IDENTIFY AND MEASURE OUTCOMES IN 1153 00:53:46,123 --> 00:53:47,925 NATURAL HISTORY STUDIES. 1154 00:53:47,925 --> 00:53:49,860 WE HAVE TO OVERCOME 1155 00:53:49,860 --> 00:53:51,361 LOGISTICS AND GIANT LOGISTICS 1156 00:53:51,361 --> 00:53:53,530 THAT PATIENTS ARE DISTRIBUTED 1157 00:53:53,530 --> 00:53:55,499 GLOBALLY THAT IS IMPORTANT TO 1158 00:53:55,499 --> 00:53:56,867 FORM GLOBAL NETWORKS THAT WE 1159 00:53:56,867 --> 00:53:58,702 HAVE ACTUALLY STARTED TO DO AND 1160 00:53:58,702 --> 00:54:02,306 THIS IS A PROBLEM THAT NEEDS TO 1161 00:54:02,306 --> 00:54:05,309 BE GLOBALLY ADVANCED. 1162 00:54:05,309 --> 00:54:07,811 GENERATED UP TO PLATFORM TRIAL 1163 00:54:07,811 --> 00:54:09,880 DESIGNS ALLOWING US TO ADD 1164 00:54:09,880 --> 00:54:11,181 DISEASES AND TREATMENTS WITHOUT 1165 00:54:11,181 --> 00:54:15,252 HAVING TO GO THROUGH PROTOCOL 1166 00:54:15,252 --> 00:54:17,054 DEVELOPMENT DEVELOPING MODULAR 1167 00:54:17,054 --> 00:54:18,388 OUTCOMES LONGITUDINALLY THAT 1168 00:54:18,388 --> 00:54:20,424 COULD BE ASSESSED AND TALKING 1169 00:54:20,424 --> 00:54:21,825 ABOUT COLLABORATIONS AND 1170 00:54:21,825 --> 00:54:23,594 DEVELOPING A CLINICAL TRIAL 1171 00:54:23,594 --> 00:54:27,664 INFRASTRUCTURE AT NIH THAT 1172 00:54:27,664 --> 00:54:29,967 ALLOWS ALSO TO SHARE DATA FROM 1173 00:54:29,967 --> 00:54:32,936 CLINICAL TRIALS GENERATED 1174 00:54:32,936 --> 00:54:33,370 INTRAMURALLY WITH 1175 00:54:33,370 --> 00:54:34,238 [INDISCERNIBLE] AND PREPARING 1176 00:54:34,238 --> 00:54:37,374 THEM EASILY FOR REGULATORY 1177 00:54:37,374 --> 00:54:37,674 SUBMISSION. 1178 00:54:37,674 --> 00:54:41,678 WITH THAT, I AM GOING TO STOP 1179 00:54:41,678 --> 00:54:42,646 HERE. 1180 00:54:42,646 --> 00:54:47,151 I HAVE NOSTALGIC SLIDES I HAVE 1181 00:54:47,151 --> 00:54:48,085 TO SHOW YOU. 1182 00:54:48,085 --> 00:54:50,721 TAKES A VILLAGE TO DO THAT AND 1183 00:54:50,721 --> 00:54:53,290 WORK AND REGULATORY WORK WAS 1184 00:54:53,290 --> 00:54:56,393 DONE ACTUALLY BY PEOPLE AT NIH 1185 00:54:56,393 --> 00:55:00,797 AND NORISSA'S DEALT WITH DATA 1186 00:55:00,797 --> 00:55:02,399 MANAGEMENT AND WITH THE CURRENT 1187 00:55:02,399 --> 00:55:04,501 TEAM. 1188 00:55:04,501 --> 00:55:05,803 THANK YOU VERY MUCH. 1189 00:55:05,803 --> 00:55:07,638 >> THANK YOU VERY MUCH. 1190 00:55:07,638 --> 00:55:12,142 YEAH. YOU KNOW, LISTENING TO 1191 00:55:12,142 --> 00:55:16,713 YOU, THERE CAN'T BE A BUSINESS 1192 00:55:16,713 --> 00:55:21,718 MODEL FOR DEVELOPING THESE 1193 00:55:21,718 --> 00:55:22,352 DRUGS. 1194 00:55:22,352 --> 00:55:25,822 PHARMACOMPANY HAVE ENGAGED IN 1195 00:55:25,822 --> 00:55:30,594 THAT FOR A DIFFERENT REASON. 1196 00:55:30,594 --> 00:55:33,463 THIS IS A SOCIETAL MODEL NOT 1197 00:55:33,463 --> 00:55:39,670 ONLY FOR SUFFERING THAT FAMILIES 1198 00:55:39,670 --> 00:55:41,605 ARE EXPERIENCING AND FOR COST 1199 00:55:41,605 --> 00:55:43,907 THAT UNTREATED DISEASES 1200 00:55:43,907 --> 00:55:47,110 ACCUMULATE AND MAYBE ENGAGEMENT 1201 00:55:47,110 --> 00:55:50,514 OF PAYERS IS REASONABLE AND THE 1202 00:55:50,514 --> 00:55:55,619 END TREATING THE DISEASES NOT 1203 00:55:55,619 --> 00:55:58,722 JUST ALLEVIATING SUFFERING AND 1204 00:55:58,722 --> 00:56:04,861 IS LESS COSTLY THAN TREATING 1205 00:56:04,861 --> 00:56:05,462 PATIENTS. 1206 00:56:05,462 --> 00:56:07,531 PETER IS THE NEXT SPEAKER. 1207 00:56:07,531 --> 00:56:09,533 THANK YOU, PETER. 1208 00:56:09,533 --> 00:56:13,503 >> HI. THANK YOU FOR INVITING 1209 00:56:13,503 --> 00:56:14,204 ME TODAY. 1210 00:56:14,204 --> 00:56:16,840 I'M PETER AND VICE PRESIDENT OF 1211 00:56:16,840 --> 00:56:18,308 CLINICAL DEVELOPMENT AT INSIGHT 1212 00:56:18,308 --> 00:56:20,811 AND TRAINED AS A PEDIATRIC 1213 00:56:20,811 --> 00:56:21,912 HEMATOLOGIST AND ONCOLOGIST AND 1214 00:56:21,912 --> 00:56:25,215 HAVE BEEN IN INDUSTRY FOR 20 1215 00:56:25,215 --> 00:56:27,084 YEARS OR SO WORKING ACROSS 1216 00:56:27,084 --> 00:56:28,885 DIFFERENT NUMBER OF COMPANIES 1217 00:56:28,885 --> 00:56:30,354 AND APPRECIATE PRESENTATIONS 1218 00:56:30,354 --> 00:56:31,321 COMING BEFORE IN THIS SESSION 1219 00:56:31,321 --> 00:56:33,657 AND DURING THE DAY TALKING ABOUT 1220 00:56:33,657 --> 00:56:35,792 VALUE OF COLLABORATION AND 1221 00:56:35,792 --> 00:56:39,363 PUBLIC AND PRIVATE FDA 1222 00:56:39,363 --> 00:56:49,806 COLLABORATION AIT IS IMPORTANT 1223 00:56:49,806 --> 00:56:51,642 WE DON'T HAVE TIME AND RESOURCES 1224 00:56:51,642 --> 00:56:53,910 TO DO EVERYTHING OR ALL OF THE 1225 00:56:53,910 --> 00:56:55,379 IDEAS AND MANY IDEAS OUT THERE 1226 00:56:55,379 --> 00:56:59,816 HAVE TO BE EXPLORED AND CAN BE 1227 00:56:59,816 --> 00:57:02,219 THROUGH COLLABORATIONS. 1228 00:57:02,219 --> 00:57:04,087 I WANT TO HIGHLIGHT IN INTEREST 1229 00:57:04,087 --> 00:57:06,890 OF TIME EXAMPLES WHERE PROJECTS 1230 00:57:06,890 --> 00:57:10,327 WORKED ON AND PHARMACEUTICAL 1231 00:57:10,327 --> 00:57:13,163 COMPANY HAD PRIORITIZATION OF 1232 00:57:13,163 --> 00:57:14,731 INDICATIONS AND COLLABORATIONS 1233 00:57:14,731 --> 00:57:16,300 EXTERNALLY AND THROUGH NIH THAT 1234 00:57:16,300 --> 00:57:20,070 WE WERE ABLE TO PROVIDE 1235 00:57:20,070 --> 00:57:21,672 TREATMENTS FOR PATIENTS WITH 1236 00:57:21,672 --> 00:57:23,540 RARE DISEASES FOR DISEASES THAT 1237 00:57:23,540 --> 00:57:25,142 DIDN'T HAVE AVAILABLE TREATMENTS 1238 00:57:25,142 --> 00:57:29,913 AND NIH IS REALLY CRITICAL IN 1239 00:57:29,913 --> 00:57:32,182 SUPPORTING THAT DEVELOPMENT. 1240 00:57:32,182 --> 00:57:33,684 FIRST [INDISCERNIBLE] IS A DRUG 1241 00:57:33,684 --> 00:57:34,985 BEING DEVELOPED THAT IS A DRUG 1242 00:57:34,985 --> 00:57:38,655 THAT IS BEING DEVELOPED FOR A 1243 00:57:38,655 --> 00:57:43,860 NUMBER OF CANCERS AND LUNG 1244 00:57:43,860 --> 00:57:46,129 CANCER THAT IS INTERESTED IN AND 1245 00:57:46,129 --> 00:57:47,731 COLLABORATION WITH RESEARCH LABS 1246 00:57:47,731 --> 00:57:50,801 LOOKING AT TARGETS THIS DRUG 1247 00:57:50,801 --> 00:57:53,337 MIGHT HAVE AND ONE LAB LOOKED AT 1248 00:57:53,337 --> 00:57:55,806 DRUGS ROLE IN EPIDERMAL GROWTH 1249 00:57:55,806 --> 00:58:02,179 FACTOR RECEPTOR INHIBITION. 1250 00:58:02,179 --> 00:58:06,683 FRIEND IN LAB SAID I'M LOOKING 1251 00:58:06,683 --> 00:58:10,554 AT RED ONCHA GENE AND HE GAVE 1252 00:58:10,554 --> 00:58:13,090 SOME IT WAS AN INHIBITOR OF 1253 00:58:13,090 --> 00:58:17,327 RECEIPT ON KA GENE THAT IS AKEY 1254 00:58:17,327 --> 00:58:21,665 DRIVER IN THOSE WITH MEDULLARY 1255 00:58:21,665 --> 00:58:22,733 CANCER WHICH IS A RARE CONDITION 1256 00:58:22,733 --> 00:58:25,369 AND AT TIME NO AVAILABLE 1257 00:58:25,369 --> 00:58:28,338 TREATMENTS SOMEONE AT NIH EXPERT 1258 00:58:28,338 --> 00:58:32,976 IN THIS CANCER AND SAW 1259 00:58:32,976 --> 00:58:35,379 PRECLINICAL DATA SHOWING THIS 1260 00:58:35,379 --> 00:58:40,650 AND BEING AT NIH CENTER FOR 1261 00:58:40,650 --> 00:58:43,253 EXCELLENCE AND HE BEING AN 1262 00:58:43,253 --> 00:58:44,988 EXPERT INITIATED A PILOT STUDY 1263 00:58:44,988 --> 00:58:49,292 AND SHOWED IN THE FIRST JUST 1264 00:58:49,292 --> 00:58:53,463 HANDFUL OF PATIENTS A NUMBER OF 1265 00:58:53,463 --> 00:58:55,699 GOOD RESPONSES AND IN PATIENTS 1266 00:58:55,699 --> 00:58:57,801 AND ULTIMATELY THE COMPANY 1267 00:58:57,801 --> 00:58:59,536 DECIDED TO DO A REGISTRATION 1268 00:58:59,536 --> 00:59:02,639 STUDY AND HAD CONVERSATIONS WITH 1269 00:59:02,639 --> 00:59:05,108 FDA AROUND THE DESIGN OF THIS. 1270 00:59:05,108 --> 00:59:06,943 IT IS IMPORTANT WE DON'T OPERATE 1271 00:59:06,943 --> 00:59:08,812 IN A VACUUM AND HAVE DISCUSSIONS 1272 00:59:08,812 --> 00:59:11,815 WITH EXPERT PHYSICIANS WITH FDA 1273 00:59:11,815 --> 00:59:16,987 AND PATIENTS WHAT IS MEANINGFUL 1274 00:59:16,987 --> 00:59:18,588 AND RELEVANT ENDPOINT STUDY 1275 00:59:18,588 --> 00:59:20,457 DESIGN AND AS A COMPANY DID 1276 00:59:20,457 --> 00:59:23,326 REGISTRATION STUDY AND NIH 1277 00:59:23,326 --> 00:59:24,761 POSITION WAS LEAD INVESTIGATOR 1278 00:59:24,761 --> 00:59:26,163 ON THAT AT THE TIME. 1279 00:59:26,163 --> 00:59:27,964 THAT ENDED UP BEING AN 1280 00:59:27,964 --> 00:59:30,534 INDICATION FOR THE DRUG THAT 1281 00:59:30,534 --> 00:59:32,569 BECAME AVAILABLE FOR THIS RARE 1282 00:59:32,569 --> 00:59:34,104 TYPE OF THYROID CANCER. 1283 00:59:34,104 --> 00:59:35,772 THE OTHER EXAMPLE I WILL MENTION 1284 00:59:35,772 --> 00:59:38,475 THAT IS AN INTERESTING CASE THAT 1285 00:59:38,475 --> 00:59:45,315 IS A DRUG ALTROMBAFAG A GROWTH 1286 00:59:45,315 --> 00:59:48,952 FACTOR SUPPORTING DEVELOPMENT OF 1287 00:59:48,952 --> 00:59:50,654 BLOOD PLATELETS AND WAS BEING 1288 00:59:50,654 --> 00:59:51,688 DEVELOPED FOR A COUPLE 1289 00:59:51,688 --> 00:59:53,223 INDICATIONS WITH THE COMPANY. 1290 00:59:53,223 --> 00:59:57,494 AND WE WERE CONTACTED BY THE NIH 1291 00:59:57,494 --> 01:00:00,597 BY A PHYSICIAN AT NIH ONE OF THE 1292 01:00:00,597 --> 01:00:04,034 WORLD'S EXPERTS IN APLASTIC 1293 01:00:04,034 --> 01:00:06,436 ANEMIA THAT, AGAIN, NOT A LOT OF 1294 01:00:06,436 --> 01:00:08,505 TREATMENTS AVAILABLE SHORT OF 1295 01:00:08,505 --> 01:00:10,674 BONE MARROW TRANSPLANT AND NOT 1296 01:00:10,674 --> 01:00:15,946 EVERYONE HAS A DONOR AVAILABLE. 1297 01:00:15,946 --> 01:00:19,749 MANY PEOPLE WOULD USE 1298 01:00:19,749 --> 01:00:21,551 HEMATOPOIETIC GROWTH FACTOR AND 1299 01:00:21,551 --> 01:00:22,953 NUMBER OF THESE WERE AVAILABLE 1300 01:00:22,953 --> 01:00:26,790 AND DIDN'T WORK AND THEY WERE 1301 01:00:26,790 --> 01:00:27,757 PRETTY EXPENSIVE AND PEOPLE 1302 01:00:27,757 --> 01:00:29,693 WOULD TRY THEM AND GIVE THEM FOR 1303 01:00:29,693 --> 01:00:31,695 A LONG PERIOD OF TIME AND THEY 1304 01:00:31,695 --> 01:00:33,363 DIDN'T WORK AND INTERESTINGLY 1305 01:00:33,363 --> 01:00:35,065 PHYSICIAN AT NIH CONTACTED US 1306 01:00:35,065 --> 01:00:37,567 AND WANTED TO DO A STUDY TO 1307 01:00:37,567 --> 01:00:40,570 PROVE THAT IT DID NOT WORK FOR 1308 01:00:40,570 --> 01:00:41,071 APLASTIC ANEMIA. 1309 01:00:41,071 --> 01:00:43,707 THIS IS PROBABLY NIH IS THE ONLY 1310 01:00:43,707 --> 01:00:47,644 PLACE YOU COULD DO THIS STUD. 1311 01:00:47,644 --> 01:00:50,013 YOU KNOW MOST PHYSICIANS AND 1312 01:00:50,013 --> 01:00:51,515 PHARMACEUTICAL COMPANIES WON'T 1313 01:00:51,515 --> 01:00:53,683 DO A STUDY TO PROVE A DRUG 1314 01:00:53,683 --> 01:00:54,484 DOESN'T WORK. 1315 01:00:54,484 --> 01:00:56,987 WE SAID FINE. WE HAD NO 1316 01:00:56,987 --> 01:00:59,456 SPECIFIC INTERESTS IN APLASTIC 1317 01:00:59,456 --> 01:01:01,558 ANEMIA AND IF THIS WOULD HELP 1318 01:01:01,558 --> 01:01:03,493 PATIENTS AND PHYSICIANS 1319 01:01:03,493 --> 01:01:04,928 UNDERSTAND HOW BEST TO TREAT IT 1320 01:01:04,928 --> 01:01:07,664 WE WILL DO IT AND IT TURNED OUT 1321 01:01:07,664 --> 01:01:09,533 THAT THE DRUG WORKED FOR 1322 01:01:09,533 --> 01:01:11,101 APLASTIC ANEMIA. 1323 01:01:11,101 --> 01:01:15,539 SO, THE NIH CONDUCTED A FAIRLY 1324 01:01:15,539 --> 01:01:17,440 EXTENSIVE STUDY SINGLE ARM STUDY 1325 01:01:17,440 --> 01:01:20,310 DIDN'T HAVE CONTROL GROUP 1326 01:01:20,310 --> 01:01:21,778 RELATIVELY RARE CONDITION AND 1327 01:01:21,778 --> 01:01:23,847 GENERATED ENCOURAGING DATA THAT 1328 01:01:23,847 --> 01:01:26,816 FROM THE NIH STUDY ENDED UP 1329 01:01:26,816 --> 01:01:30,654 SUPPORTING FDA APPROVAL FOR 1330 01:01:30,654 --> 01:01:31,321 APLASTIC ANEMIA. 1331 01:01:31,321 --> 01:01:32,856 THERE ARE DIFFERENT WAYS THAT 1332 01:01:32,856 --> 01:01:35,292 COLLABORATIONS CAN WORK AND YOU 1333 01:01:35,292 --> 01:01:37,928 CAN HAND OVER ENTIRE DRUG IF 1334 01:01:37,928 --> 01:01:39,663 PHARMACOMPANY HAS NO INTEREST IN 1335 01:01:39,663 --> 01:01:41,731 DRUG AND HAND OVER DRUG TO NIH 1336 01:01:41,731 --> 01:01:44,167 AND LET THEM GO WITH IT AND HAND 1337 01:01:44,167 --> 01:01:46,469 OVER A PORTION OF THE 1338 01:01:46,469 --> 01:01:47,804 DEVELOPMENT IF INDICATIONS ARE 1339 01:01:47,804 --> 01:01:51,775 RARE WHERE NIH HAS PARTICULAR 1340 01:01:51,775 --> 01:01:53,343 EXPERTISE AND TRANSLATIONAL 1341 01:01:53,343 --> 01:01:54,945 SCIENCE THAT WAS TALKED ABOUT 1342 01:01:54,945 --> 01:01:56,680 BEFORE AND HANDING OVER PARTS OF 1343 01:01:56,680 --> 01:01:58,515 DEVELOPMENT THERE AND YOU CAN 1344 01:01:58,515 --> 01:02:03,253 GET FDA APPROVAL THROUGH NIH 1345 01:02:03,253 --> 01:02:04,588 COLLABORATIONS AND COMPANY 1346 01:02:04,588 --> 01:02:06,256 SPONSORED TRIALS WITH KEY 1347 01:02:06,256 --> 01:02:08,191 INVOLVEMENT OF NIH EXPERTS OR IN 1348 01:02:08,191 --> 01:02:12,262 CASE OF APLASTIC ANEMIA THAT IS 1349 01:02:12,262 --> 01:02:14,631 APPROVAL BASED SOLELY ON STUDIES 1350 01:02:14,631 --> 01:02:15,732 DONE AT NIH. 1351 01:02:15,732 --> 01:02:17,133 I WILL CLOSE THERE. 1352 01:02:17,133 --> 01:02:20,070 I WILL SAY THAT THERE ARE 1353 01:02:20,070 --> 01:02:21,438 OBSTACLES AT PHARMACEUTICAL 1354 01:02:21,438 --> 01:02:23,106 COMPANIES AND CLEARLY THERE ARE 1355 01:02:23,106 --> 01:02:24,841 CONCERNS IF YOU GO INTO NEW 1356 01:02:24,841 --> 01:02:27,677 INDICATION YOU WILL GET FINDINGS 1357 01:02:27,677 --> 01:02:29,746 THAT ADVERSELY EFFECT APPROVED 1358 01:02:29,746 --> 01:02:30,914 INDICATIONS AND SAFETY PROFILE 1359 01:02:30,914 --> 01:02:33,116 AND QUESTIONS AROUND RESOURCES 1360 01:02:33,116 --> 01:02:34,551 INVOLVED AND OPPORTUNITIES FOR 1361 01:02:34,551 --> 01:02:37,253 EXPANDING INDICATIONS THAT ARE 1362 01:02:37,253 --> 01:02:40,690 PARTICULARLY IN RARE DISEASES 1363 01:02:40,690 --> 01:02:43,827 OFTEN AT NIH CENTERS FOR 1364 01:02:43,827 --> 01:02:45,629 EXCELLENTS AND PATIENTS AROUND 1365 01:02:45,629 --> 01:02:46,796 THE WORLD COME THERE AND 1366 01:02:46,796 --> 01:02:48,098 OPPORTUNITY FOR US TO EXPLORE 1367 01:02:48,098 --> 01:02:50,000 NEW INDICATIONS AND PROVIDE 1368 01:02:50,000 --> 01:02:54,337 VALUE FOR PATIENTS AND NEW 1369 01:02:54,337 --> 01:03:00,710 OPPORTUNITIES FOR THERAPEUTICS. 1370 01:03:00,710 --> 01:03:03,146 I'LL PAUSE THERE. I CAN TAKE 1371 01:03:03,146 --> 01:03:04,314 QUESTIONS FOR LATER. 1372 01:03:04,314 --> 01:03:11,821 >> I WAS LAUGHING AND SAID 1373 01:03:11,821 --> 01:03:13,089 CLINICAL TRIAL AND INDEED IS 1374 01:03:13,089 --> 01:03:17,627 POSSIBLE AT NIH AND WILL TAKE 1375 01:03:17,627 --> 01:03:18,762 SERIOUSLY IN THIS KNOWLEDGE 1376 01:03:18,762 --> 01:03:20,196 ASPECT OF DISEASES. 1377 01:03:20,196 --> 01:03:25,368 IT IS -- IT IS VERY FRUSTRATING 1378 01:03:25,368 --> 01:03:29,639 WHEN PHARMACEUTICAL COMPANIES 1379 01:03:29,639 --> 01:03:32,609 ABANDON DRUG WITHOUT 1380 01:03:32,609 --> 01:03:37,247 UNDERSTANDING WHY IT DIDN'T WORK 1381 01:03:37,247 --> 01:03:39,382 UNDERSTANDING IS ESSENTIAL FOR 1382 01:03:39,382 --> 01:03:42,719 DEVELOPMENT OF BETTER DRUGS THAT 1383 01:03:42,719 --> 01:03:50,627 IS WHAT WE DO AT NIH CLINICAL 1384 01:03:50,627 --> 01:03:54,698 CENT 1385 01:03:54,698 --> 01:03:56,166 CENTER. 1386 01:03:56,166 --> 01:03:58,234 RAPH 1387 01:03:58,234 --> 01:04:00,070 RAPHAELA PRESENTATION NOT ALL 1388 01:04:00,070 --> 01:04:04,340 NIH IS UNIQUELY PHENOTYPED AND 1389 01:04:04,340 --> 01:04:07,877 LEVEL OF MEASUREMENTS AND 1390 01:04:07,877 --> 01:04:10,413 PHENOTYPING OF DISEASE THAT IS 1391 01:04:10,413 --> 01:04:12,716 INTRAMURAL RESEARCH PROGRAM IS 1392 01:04:12,716 --> 01:04:14,217 UNPRECEDENTED AND BEEN AT 1393 01:04:14,217 --> 01:04:16,119 UNIVERSITY AND IT IS 1394 01:04:16,119 --> 01:04:16,553 UNPRECEDENTED. 1395 01:04:16,553 --> 01:04:18,321 YEAH. I THINK THAT IS ONE OF 1396 01:04:18,321 --> 01:04:20,323 THE REASONS WE WANT TO REALLY 1397 01:04:20,323 --> 01:04:22,792 ORGANIZE THIS MEETING BECAUSE I 1398 01:04:22,792 --> 01:04:25,895 THINK THAT A LOT OF -- A LOT OF 1399 01:04:25,895 --> 01:04:27,430 DRUG COMPANIES DON'T UNDERSTAND 1400 01:04:27,430 --> 01:04:31,801 HOW UNIQUE THIS ENVIRONMENT IS 1401 01:04:31,801 --> 01:04:35,105 FOR -- THANK YOU. 1402 01:04:35,105 --> 01:04:38,675 THIS IS DEFINITELY SOMEBODY THAT 1403 01:04:38,675 --> 01:04:41,111 UNDERSTANDS AND HAS BEEN AT NIH 1404 01:04:41,111 --> 01:04:46,149 AND IS AT THERAPEUTICS. 1405 01:04:46,149 --> 01:04:46,683 PLEASE. 1406 01:04:46,683 --> 01:04:48,885 >> AS DEDIMENSIONED I'M A 1407 01:04:48,885 --> 01:04:51,221 PHYSICIAN SCIENTISTS PREVIOUS 1408 01:04:51,221 --> 01:04:54,224 INVESTIGATOR AT NIH WITH 1409 01:04:54,224 --> 01:04:56,526 RESEARCH FOCUS AT T-CELL 1410 01:04:56,526 --> 01:04:57,360 PATHOGENESIS AND INFORMATION 1411 01:04:57,360 --> 01:05:00,363 THAT IS FUNDAMENTAL INFLAMMATION 1412 01:05:00,363 --> 01:05:03,633 IN MOST ALLERGIC DISEASES AND 1413 01:05:03,633 --> 01:05:06,069 ASTHMA WORKED ON PROJECTS TO 1414 01:05:06,069 --> 01:05:07,370 REPOSITION AND APPROVE DRUGS 1415 01:05:07,370 --> 01:05:09,906 WON'T GET INTO THAT AND LEFT NIH 1416 01:05:09,906 --> 01:05:13,143 IN 2016 AND JOINED A SMALL 1417 01:05:13,143 --> 01:05:16,780 COMPANY AND NOT BIOSCIENCES TO 1418 01:05:16,780 --> 01:05:22,485 DEVELOP A DRUG DRAMA PRAMA 1419 01:05:22,485 --> 01:05:26,389 PECHLEL STORY THAT I WILL 1420 01:05:26,389 --> 01:05:28,625 BRIEFLY TELL YOU WITH DRUG 1421 01:05:28,625 --> 01:05:30,860 REPURPOSING NEW INDICATIONS AND 1422 01:05:30,860 --> 01:05:32,862 ALSO VERY MUCH INVOLVING 1423 01:05:32,862 --> 01:05:34,230 ACADEMIC INDUSTRY COLLABORATION 1424 01:05:34,230 --> 01:05:36,733 AND COLLABORATIONS WITH NIH AND 1425 01:05:36,733 --> 01:05:40,370 ALSO INTERESTINGLY WITH ANJAN 1426 01:05:40,370 --> 01:05:44,140 AND SIMON ON THIS PANEL. 1427 01:05:44,140 --> 01:05:45,708 STRONG NEUROSCIENCE RUNNING 1428 01:05:45,708 --> 01:05:49,846 THROUGH WITH ALS AND 1429 01:05:49,846 --> 01:05:50,380 PARKINSON'S. 1430 01:05:50,380 --> 01:05:53,650 PRAMA PECHLEL IS AN APPROVED 1431 01:05:53,650 --> 01:05:57,320 DOPAMINE AGONIST DRUG USED IN 1432 01:05:57,320 --> 01:05:59,823 TREATMENT OF PARKINSON'S DISEASE 1433 01:05:59,823 --> 01:06:02,192 AND YEARS BACK INVESTIGATORS 1434 01:06:02,192 --> 01:06:05,295 FOUND IT WAS NEUROPROTECTIVE 1435 01:06:05,295 --> 01:06:07,730 AGAINST OXIDATIVE STRESS HAVING 1436 01:06:07,730 --> 01:06:11,434 CLINICAL ACTIVITY AND 1437 01:06:11,434 --> 01:06:13,469 NEUROPROTECTIVE DISEASES AND 1438 01:06:13,469 --> 01:06:14,904 CONCENTRATIONS REQUIRED WOULD BE 1439 01:06:14,904 --> 01:06:17,173 TOXIC BECAUSE OF DOPAMINE 1440 01:06:17,173 --> 01:06:20,109 ACTIVITY AND JAMES AT UVA 1441 01:06:20,109 --> 01:06:24,380 HYPOTHESIZED THAT RIGHT-HANDED 1442 01:06:24,380 --> 01:06:28,418 ANAN TOMORROWER DECHL OR 1443 01:06:28,418 --> 01:06:30,019 DEPROEPO PECHLEL WOULD HAVE THIS 1444 01:06:30,019 --> 01:06:32,589 EFFECT AND NOT DOPAMINE TOXICITY 1445 01:06:32,589 --> 01:06:34,557 AND WAS RIGHT AND DID EARLY 1446 01:06:34,557 --> 01:06:37,527 PILOT INVESTIGATIONS AND 1447 01:06:37,527 --> 01:06:40,597 PARKINSON'S AND ALS AND LICENSED 1448 01:06:40,597 --> 01:06:43,833 DRUGS TO SMALL 1449 01:06:43,833 --> 01:06:44,801 BIOPHARMABIOSCIENCES AND WENT 1450 01:06:44,801 --> 01:06:46,269 FORWARD WITH CLINICAL 1451 01:06:46,269 --> 01:06:47,470 DEVELOPMENT WITH PROOF OF 1452 01:06:47,470 --> 01:06:49,973 CONCEPT PHASE 2 STUDY IN ALS 1453 01:06:49,973 --> 01:06:51,708 THAT WAS SUCCESSFUL AND PHASE 3 1454 01:06:51,708 --> 01:06:54,844 OF FAILED TO REPLICATE PRIMARY 1455 01:06:54,844 --> 01:06:56,846 ENDPOINT AND DURING CLINICAL 1456 01:06:56,846 --> 01:07:00,183 DEVELOPMENT THEY NOTICED THAT IT 1457 01:07:00,183 --> 01:07:02,485 LOWERED EO SINOFILL ACCOUNTS AND 1458 01:07:02,485 --> 01:07:06,422 SAME TIME ANTI-IL5 BIOLOGICS 1459 01:07:06,422 --> 01:07:09,325 WERE SHOWN TO EFFECTIVELY TREAT 1460 01:07:09,325 --> 01:07:13,029 ASTHMA BY LOWERING EO SINOFILL 1461 01:07:13,029 --> 01:07:16,532 ACCOUNTS AND IT IS A SMALL 1462 01:07:16,532 --> 01:07:23,806 MOLECULE TAKEN ORAL LY 1463 01:07:23,806 --> 01:07:26,910 THERAPEUTIC ADVANCE AND PIFR 1464 01:07:26,910 --> 01:07:29,279 OTED DEVELOPMENT TO 1465 01:07:29,279 --> 01:07:29,879 [INDISCERNIBLE] DISEASES AT 1466 01:07:29,879 --> 01:07:31,414 WHICH POINT THAT IS WHEN I 1467 01:07:31,414 --> 01:07:33,716 JOINED AND WE COMPLETED A 1468 01:07:33,716 --> 01:07:37,253 CLINICAL PROOF OF CONCEPT STUDY 1469 01:07:37,253 --> 01:07:39,355 IN [INDISCERNIBLE] SYNDROME PART 1470 01:07:39,355 --> 01:07:43,826 OF COOPERATIVE RESEARCH AND 1471 01:07:43,826 --> 01:07:46,029 DEVELOPMENT AGREEMENT WITH AMY 1472 01:07:46,029 --> 01:07:48,765 CLEEON AT NAEID AND LATER 1473 01:07:48,765 --> 01:07:52,402 COMPANY I HEADED UP A PHASE 2 1474 01:07:52,402 --> 01:07:55,171 PROOF OF CONCEPT TRIAL AND IT 1475 01:07:55,171 --> 01:07:57,407 WAS SUCCESSFUL. WE ARE IN PHASE 1476 01:07:57,407 --> 01:07:59,275 3 OF THE DRUG. 1477 01:07:59,275 --> 01:08:01,511 LOTS OF REPURPOSING AND SORT OF 1478 01:08:01,511 --> 01:08:04,847 WHAT -- YOU KNOW, TRYING TO FIND 1479 01:08:04,847 --> 01:08:06,649 WHERE DOES THIS DRUG HAVE A HOME 1480 01:08:06,649 --> 01:08:09,252 IN TERMS OF TREATING DISEASE 1481 01:08:09,252 --> 01:08:13,056 THAT HAS GONE ALONG THE WAY AND 1482 01:08:13,056 --> 01:08:15,158 THINK THAT REALLY RIGHT NOW 1483 01:08:15,158 --> 01:08:17,093 SEEING THE FRUIT OF THAT IN 1484 01:08:17,093 --> 01:08:19,395 PHASE 3 TRIALS. 1485 01:08:19,395 --> 01:08:22,565 I WILL STOP THERE FOR INTEREST 1486 01:08:22,565 --> 01:08:23,299 OF TIME. 1487 01:08:23,299 --> 01:08:24,934 I WILL JOIN THE DISCUSSION 1488 01:08:24,934 --> 01:08:25,335 LATER. 1489 01:08:25,335 --> 01:08:28,338 >> THANK YOU VERY MUCH. 1490 01:08:28,338 --> 01:08:33,876 LAST SPEAKER IS SIMON. 1491 01:08:33,876 --> 01:08:37,613 SIMON SCOTT. 1492 01:08:37,613 --> 01:08:40,583 HE IS FROM THE FRON PROFIT 1493 01:08:40,583 --> 01:08:43,886 SECTOR WITH AN INTERESTING STORY 1494 01:08:43,886 --> 01:08:45,722 TO SAY. 1495 01:08:45,722 --> 01:08:49,525 >> THANK YOU I'M SIMON AND 1496 01:08:49,525 --> 01:08:52,061 DIRECTOR THAT IS WITH A RESEARCH 1497 01:08:52,061 --> 01:08:54,530 CHARITY IN THE UK AND FUND 1498 01:08:54,530 --> 01:08:56,332 RESEARCH INTERNATIONALLY 1499 01:08:56,332 --> 01:08:58,401 PRECLINICAL AND CLINICAL FOCUSED 1500 01:08:58,401 --> 01:09:01,070 ON DISEASE MODIFICATION FOR 1501 01:09:01,070 --> 01:09:02,538 PARKINSON'S AND BEEN WITH THE 1502 01:09:02,538 --> 01:09:03,539 ORGANIZATION FOR FIVE YEARS AND 1503 01:09:03,539 --> 01:09:05,441 BEFORE THAT DID IDEAS OF 1504 01:09:05,441 --> 01:09:09,145 RESEARCH IN ACADEMIC AND BIOTECH 1505 01:09:09,145 --> 01:09:11,247 RESEARCH IN LAB AND CLINICAL AND 1506 01:09:11,247 --> 01:09:17,820 ORGANIZATION WAS FOUNDED IN 2005 1507 01:09:17,820 --> 01:09:20,456 BY FOUR JA GENTLEMEN FOCUSED ON 1508 01:09:20,456 --> 01:09:23,292 LACK OF RESEARCH IN ACTUALLY 1509 01:09:23,292 --> 01:09:24,761 CURING THE CONDITION AND IN 2011 1510 01:09:24,761 --> 01:09:31,801 WHEN THEY FOUND THEIR FEET THEY 1511 01:09:31,801 --> 01:09:34,470 INITIATED TRIALS PROGRAM ILCT 1512 01:09:34,470 --> 01:09:36,773 STARTING OUT AT DRUG REPURPOSING 1513 01:09:36,773 --> 01:09:39,876 PROGRAM THAT TOOK INSPIRATION 1514 01:09:39,876 --> 01:09:45,581 FROM NIH SYNAPSE PROGRAM IN 1515 01:09:45,581 --> 01:09:45,782 2003. 1516 01:09:45,782 --> 01:09:50,520 THIS WAS THE COMMITTEE TO 1517 01:09:50,520 --> 01:09:51,421 IDENTIFY NEOPROTECTIVE AGENTS 1518 01:09:51,421 --> 01:09:55,024 FOR PARKINSON'S AND EMPHASIS WAS 1519 01:09:55,024 --> 01:09:57,960 TO HAVE AN INTERNATIONAL 1520 01:09:57,960 --> 01:10:02,031 COMMITTEE OF PARKINSON'S EXPERTS 1521 01:10:02,031 --> 01:10:05,868 AND MEET EVERY YEAR WITH PURPOSE 1522 01:10:05,868 --> 01:10:08,504 OF EVALUATING MOLECULES WITH 1523 01:10:08,504 --> 01:10:10,106 EVIDENCE OF DISEASE FOR 1524 01:10:10,106 --> 01:10:12,809 MODIFICATION OF PARKINSON'S 1525 01:10:12,809 --> 01:10:14,143 ACCELERATING THEM INTO CLINICAL 1526 01:10:14,143 --> 01:10:16,946 TRIALS AND INVOLVES A TWO-DAY 1527 01:10:16,946 --> 01:10:18,681 FACE-TO-FACE MEETING THAT IS 1528 01:10:18,681 --> 01:10:22,952 HELD IN LONDON OR GRAND RAPIDS 1529 01:10:22,952 --> 01:10:25,221 MICHIGAN WITH PARTNERS VAN 1530 01:10:25,221 --> 01:10:28,925 HANDLE INSTITUTE AND BASIC AIM 1531 01:10:28,925 --> 01:10:32,795 IS TO DEBATE EVALUATE AND RANK 1532 01:10:32,795 --> 01:10:35,431 AND PRIORITIZE A SET OF DOSSIERS 1533 01:10:35,431 --> 01:10:37,433 WE PRESENT TO THE COMMITTEE EACH 1534 01:10:37,433 --> 01:10:39,702 YEAR MADE UP OF 23 LEADING 1535 01:10:39,702 --> 01:10:40,903 EXPERTS IN THE WORLD AND ARE 1536 01:10:40,903 --> 01:10:44,173 BEST OF THE BEST AND WONDERFUL 1537 01:10:44,173 --> 01:10:45,508 PEOPLE AND PRESENT TWO WEEKS 1538 01:10:45,508 --> 01:10:48,377 BEFORE A MEETING WITH SET OF 1539 01:10:48,377 --> 01:10:51,481 DOSSIERS 15 TO 20 DOSSIERS, 20 1540 01:10:51,481 --> 01:10:53,149 PAGES EACH AND IN EACH WE HAVE 1541 01:10:53,149 --> 01:10:54,750 EVERYTHING WE KNOW ABOUT A 1542 01:10:54,750 --> 01:10:59,822 PARTICULAR MOLECULE THAT HAS 1543 01:10:59,822 --> 01:11:05,962 PRESENTED SOME EVIDENCE AND THEY 1544 01:11:05,962 --> 01:11:10,099 ARE WRITTEN IN HOUSE BY RESEARCH 1545 01:11:10,099 --> 01:11:13,903 TEAMS IN PARKINSON'S AND 2012 1546 01:11:13,903 --> 01:11:16,272 SINCE THEN 239 DOSSIERS 1547 01:11:16,272 --> 01:11:17,940 PRESENTED TO THE COMMITTEE 1548 01:11:17,940 --> 01:11:20,309 REPRESENTING TOTAL OF 171 AGENTS 1549 01:11:20,309 --> 01:11:24,781 NOT ALL ARE REPURPOSED MOLECULES 1550 01:11:24,781 --> 01:11:26,482 AND SO MUCH AGENCY YOU CAN 1551 01:11:26,482 --> 01:11:29,819 INCREASE AND LOOKING TOWARDS 1552 01:11:29,819 --> 01:11:31,687 CHEMICAL ENTITIES HOPING TO 1553 01:11:31,687 --> 01:11:32,889 ACCELERATE THEM TO THE CLINIC 1554 01:11:32,889 --> 01:11:35,691 AND PROGRAM ASSOCIATED WITH 20 1555 01:11:35,691 --> 01:11:40,563 COMPLETED TRIALS AND 21 ONGOING 1556 01:11:40,563 --> 01:11:48,271 STUDIES. 1557 01:11:48,271 --> 01:11:51,073 IN ADDITION TO PRIORITIZING 1558 01:11:51,073 --> 01:11:52,808 MOLECULES COMMITTEE HAS AVENUE 1559 01:11:52,808 --> 01:11:55,344 FOR FUNDING IF A MOLECULE IS 1560 01:11:55,344 --> 01:11:56,479 CONSIDERED NOT READY FOR PRIME 1561 01:11:56,479 --> 01:11:58,381 TIME TO GO TO A CLINICAL TRIAL 1562 01:11:58,381 --> 01:12:02,485 THEY CAN SEND IT BACK TO -- 1563 01:12:02,485 --> 01:12:10,293 THROUGH A PROGRAM WE CALL ILTT 1564 01:12:10,293 --> 01:12:12,862 RESEARCH ACCELERATION PROGRAM 1565 01:12:12,862 --> 01:12:15,932 AND ASK RESEARCHERS TO -- TO DO 1566 01:12:15,932 --> 01:12:17,300 A PARTICULAR STUDY. 1567 01:12:17,300 --> 01:12:19,268 JUST WANTED TO GO THROUGH A 1568 01:12:19,268 --> 01:12:21,671 COUPLE OF EXAMPLES QUICKLY AT 1569 01:12:21,671 --> 01:12:22,371 THIS TIME. 1570 01:12:22,371 --> 01:12:24,473 ONE MOLECULE THAT IS PREVIOUSLY 1571 01:12:24,473 --> 01:12:26,509 BEING DISCUSSED HERE TODAY IS 1572 01:12:26,509 --> 01:12:30,079 GOP1 AGONISTS THAT IS SHOWING 1573 01:12:30,079 --> 01:12:31,547 ENCOURAGING DATA IN PARKINSON'S 1574 01:12:31,547 --> 01:12:35,818 AND TO CURE IT FUNDED AN EARLY 1575 01:12:35,818 --> 01:12:38,888 STUDY WITH THIS MOLECULE OR 1576 01:12:38,888 --> 01:12:40,790 EX-ENO TIED AND PHASE 3 CLINICAL 1577 01:12:40,790 --> 01:12:42,892 TRIAL COMING TO END IN FEBRUARY 1578 01:12:42,892 --> 01:12:44,894 OF THIS YEAR AND RESULTS OF THAT 1579 01:12:44,894 --> 01:12:47,396 COME IN MIDDLE OF THE YEAR AND 1580 01:12:47,396 --> 01:12:48,664 REPRESENTS A CHALLENGE IN TERMS 1581 01:12:48,664 --> 01:12:51,100 OF NEXT STEPS GOING TO 1582 01:12:51,100 --> 01:12:52,969 REGULATORS AND IF THE RESULTS 1583 01:12:52,969 --> 01:12:53,703 ARE POSITIVE. 1584 01:12:53,703 --> 01:12:57,440 BUT IF THE RESULTS ARE POSITIVE 1585 01:12:57,440 --> 01:12:59,141 IT ALSO REPRESENTS EXCELLENT 1586 01:12:59,141 --> 01:13:00,810 OPPORTUNITY AS AJ WAS SUGGESTING 1587 01:13:00,810 --> 01:13:03,379 IN TERMS OF POTENTIAL FOR 1588 01:13:03,379 --> 01:13:05,681 COMBINATION THERAPIES. 1589 01:13:05,681 --> 01:13:08,517 WE ALSO HAVE ANBROCHLEL WHICH IS 1590 01:13:08,517 --> 01:13:11,053 A RESPIRATORY MEDICATION 1591 01:13:11,053 --> 01:13:14,123 LICENSED IN EUROPE BUT NOT IN UK 1592 01:13:14,123 --> 01:13:17,660 OR AMERICA AND DRUG SCREENING 1593 01:13:17,660 --> 01:13:28,137 STUDY COMMON RISK FACTOR IS 1594 01:13:37,313 --> 01:13:39,715 [INDISCERNIBLE] AND SETTING UP 1595 01:13:39,715 --> 01:13:43,252 KAZ 3 CLINICAL TRIAL TO TEST IN 1596 01:13:43,252 --> 01:13:53,796 THE UK -- TAKING 21 PILLS A DAY 1597 01:14:00,736 --> 01:14:02,938 FOR 6 MONTHS ON TOP OF DOPAMINE 1598 01:14:02,938 --> 01:14:05,308 MEDICATION THEY WERE TAKING AND 1599 01:14:05,308 --> 01:14:07,376 HEROIC EFFORT IT IS A 1600 01:14:07,376 --> 01:14:09,512 [INDISCERNIBLE] TASTING PILL AND 1601 01:14:09,512 --> 01:14:11,547 REFORMULATED THAT DOWN TO THREE 1602 01:14:11,547 --> 01:14:12,982 PILLS A DAY. 1603 01:14:12,982 --> 01:14:18,521 BUT THIS IS ONE OF THE HURDLES 1604 01:14:18,521 --> 01:14:20,156 YOU FACE WITH DRUG REPURPOSING 1605 01:14:20,156 --> 01:14:23,626 OF COURSE AND MOLECULES 1606 01:14:23,626 --> 01:14:25,194 PRIORITIZED BY THE COMMITTEE 1607 01:14:25,194 --> 01:14:28,197 GOING INTO THIRD PARTY CLINICAL 1608 01:14:28,197 --> 01:14:33,502 TRIAL PLATFORMS FOR EXAMPLE 1609 01:14:33,502 --> 01:14:34,337 AUSTRALIAN PARKINSON'S 1610 01:14:34,337 --> 01:14:37,073 [INDISCERNIBLE] AND THREE ARMS 1611 01:14:37,073 --> 01:14:39,141 VERSUS PLACEBO AND IN UK SETTING 1612 01:14:39,141 --> 01:14:42,411 UP A PLATFORM FOR PARKINSON'S 1613 01:14:42,411 --> 01:14:44,847 CALLED EJS OR [INDISCERNIBLE] 1614 01:14:44,847 --> 01:14:47,249 ACCELERATING CLINICAL TRIALS OF 1615 01:14:47,249 --> 01:14:49,018 PARKINSON'S AT PD AND SOMETHING 1616 01:14:49,018 --> 01:14:50,786 TO KEEP AN EYE OUT FOR AND IF 1617 01:14:50,786 --> 01:14:53,589 INTERESTED IN OUR WORK WE HAD A 1618 01:14:53,589 --> 01:14:55,825 12 YEAR REVIEW MANUSCRIPT 1619 01:14:55,825 --> 01:14:57,526 CURRENTLY AT JOURNAL OF 1620 01:14:57,526 --> 01:15:01,464 PARKINSON'S PROVIETDING NOT ONLY 1621 01:15:01,464 --> 01:15:02,999 LESSONS WE HAVE LEARNED AND 1622 01:15:02,999 --> 01:15:06,202 SUMMARY OF MOLECULES THAT HAVE 1623 01:15:06,202 --> 01:15:11,540 BEEN NONCONFIDENTIAL MOLECULES 1624 01:15:11,540 --> 01:15:13,242 BEING EVALUATED BY THE COMMITTEE 1625 01:15:13,242 --> 01:15:15,077 AND BEYOND THAT I WILL STOP AND 1626 01:15:15,077 --> 01:15:17,246 SET ENOUGH AND WILL HAND IT BACK 1627 01:15:17,246 --> 01:15:18,447 TO DEDE. 1628 01:15:18,447 --> 01:15:21,050 >> THANK YOU VERY MUCH, SIMON. 1629 01:15:21,050 --> 01:15:23,652 OKAY. I THINK WE HAVE ALL 1630 01:15:23,652 --> 01:15:26,689 PANELISTS AVAILABLE. 1631 01:15:26,689 --> 01:15:31,460 AND I CAN SEE ONE QUESTION THAT 1632 01:15:31,460 --> 01:15:35,031 CHRISTINE ANSWERED IN CHAT AND 1633 01:15:35,031 --> 01:15:40,169 MAYBE CAN ANSWER IT HERE AND 1634 01:15:40,169 --> 01:15:42,037 QUESTION IS INTEREST OF PAYERS 1635 01:15:42,037 --> 01:15:44,273 MAKING GENERATIVE DRUGS 1636 01:15:44,273 --> 01:15:45,808 AVAILABLE FOR NEW USES AND 1637 01:15:45,808 --> 01:15:48,344 LARGEST US PAYERS ARE FEDERAL 1638 01:15:48,344 --> 01:15:50,146 AND STATE GOVERNMENTS. 1639 01:15:50,146 --> 01:15:52,515 IS THERE ANY THOUGHT FOR NIH TO 1640 01:15:52,515 --> 01:15:55,418 SUPPORT STUDIES WITH THE AIM TO 1641 01:15:55,418 --> 01:15:57,720 REDUCE DRUG COSTS FOR MEDICARE 1642 01:15:57,720 --> 01:15:58,587 AND MEDICAID? 1643 01:15:58,587 --> 01:16:00,956 >> IT IS A GREAT QUESTION THAT 1644 01:16:00,956 --> 01:16:03,726 I'M GLAD THERE IS SOMEBODY OUT 1645 01:16:03,726 --> 01:16:06,028 THERE WHO IS THINKING ABOUT CMS 1646 01:16:06,028 --> 01:16:07,263 AND THINKING ABOUT THAT 1647 01:16:07,263 --> 01:16:11,534 PERSPECTIVE THAT IS IN A 1648 01:16:11,534 --> 01:16:12,802 FANTASTIC POSITION PARTICULARLY 1649 01:16:12,802 --> 01:16:15,037 TO HELP US IDENTIFY EVEN, YOU 1650 01:16:15,037 --> 01:16:18,274 KNOW, WHAT ARE SOME THINGS THAT 1651 01:16:18,274 --> 01:16:20,776 ARE PARTICULARLY COSTLY TO THE 1652 01:16:20,776 --> 01:16:22,244 HEALTHCARE SYSTEM. 1653 01:16:22,244 --> 01:16:24,647 WE HAVE ACTUALLY SPOKEN WITH 1654 01:16:24,647 --> 01:16:25,881 THEM AND SPOKE WITH THEM A 1655 01:16:25,881 --> 01:16:27,550 NUMBER OF TIMES AND THERE ARE 1656 01:16:27,550 --> 01:16:29,251 SOME LIMITATIONS THAT WE RUN 1657 01:16:29,251 --> 01:16:33,722 INTO WITH PARTNERING WITH CMS 1658 01:16:33,722 --> 01:16:35,257 AND ARE LIMITATIONS IN TERMS 1659 01:16:35,257 --> 01:16:38,160 WHAT THEY ARE ABLE TO DO AND -- 1660 01:16:38,160 --> 01:16:39,228 AND NOT DO. 1661 01:16:39,228 --> 01:16:42,364 THEY GIVE US A REALLY, REALLY 1662 01:16:42,364 --> 01:16:43,933 GOOD PERSPECTIVE FROM THAT -- 1663 01:16:43,933 --> 01:16:46,102 YOU KNOW, PAYER -- THAT PAYER 1664 01:16:46,102 --> 01:16:47,436 SIDE OF THINGS. 1665 01:16:47,436 --> 01:16:49,505 WE HAVE SPOKEN WITH THEM ABOUT 1666 01:16:49,505 --> 01:16:52,575 IDEAS WHAT IT IS WE WANT TO DO 1667 01:16:52,575 --> 01:16:56,278 AND FROM A -- JUST FROM A 1668 01:16:56,278 --> 01:16:59,081 PERSPECTIVE IT MAKES SENSE TO 1669 01:16:59,081 --> 01:17:00,816 THEM AND WOULD BE WORTH PURSUING 1670 01:17:00,816 --> 01:17:05,721 AND IS HARD FOR THEM TO ENGAGE 1671 01:17:05,721 --> 01:17:10,092 DIRECTLY WITH US ON THINGS WE 1672 01:17:10,092 --> 01:17:15,631 WANT TO DO AND GREAT THOUGHT. 1673 01:17:15,631 --> 01:17:18,133 WE SPOKE WITH THE VA THAT HAS 1674 01:17:18,133 --> 01:17:20,836 OWN CLOSED ECOSYSTEM IN A WAY. 1675 01:17:20,836 --> 01:17:24,139 YOU HAVE RESEARCH CONDUCTED AT 1676 01:17:24,139 --> 01:17:27,209 VA AND AS WELL AS SEEING 1677 01:17:27,209 --> 01:17:29,445 PATIENTS AND OWN SORT OF PAYER 1678 01:17:29,445 --> 01:17:31,614 SYSTEM. WE SPOKE WITH THEM AND 1679 01:17:31,614 --> 01:17:33,716 IS ANOTHER PLACE IT MIGHT BE A 1680 01:17:33,716 --> 01:17:37,853 GOOD WAY TO PILOT STRATEGIES FOR 1681 01:17:37,853 --> 01:17:40,489 ENGAGING PAYERS. 1682 01:17:40,489 --> 01:17:44,727 >> OKAY. YOU KNOW, I THINK 1683 01:17:44,727 --> 01:17:47,062 PUBLIC VERY OFTEN TALKS ABOUT, 1684 01:17:47,062 --> 01:17:50,232 YOU KNOW, AI DESIGNING DRUGS. 1685 01:17:50,232 --> 01:17:57,473 IT DOESN'T SEEM TO ME THAT 1686 01:17:57,473 --> 01:17:59,041 BOTTLENECK IN DRUG DEVELOPMENT 1687 01:17:59,041 --> 01:18:01,977 IS DESIGNING A DRUG THAT ENGAGES 1688 01:18:01,977 --> 01:18:03,779 TARGET; RIGHT? 1689 01:18:03,779 --> 01:18:06,348 BOTTLENECK IS VALIDATING THE 1690 01:18:06,348 --> 01:18:08,517 TARGET THAT YOU HAVE RIGHT 1691 01:18:08,517 --> 01:18:12,421 TARGET AND DOING CLINICAL 1692 01:18:12,421 --> 01:18:12,922 TRIALS. 1693 01:18:12,922 --> 01:18:14,890 RIGHT? 1694 01:18:14,890 --> 01:18:16,959 SO S 1695 01:18:16,959 --> 01:18:20,729 SO, IN A PREVIOUS SESSION IT WAS 1696 01:18:20,729 --> 01:18:22,865 MENTIONED THAT SOMETIMES THE 1697 01:18:22,865 --> 01:18:25,935 WINNER DRUG IS NOT THE FIRST 1698 01:18:25,935 --> 01:18:26,201 DRUG. 1699 01:18:26,201 --> 01:18:30,372 IT IS THE BEST DRUG; RIGHT? 1700 01:18:30,372 --> 01:18:33,909 CLEARLY YOU KNOW ONE OF THE 1701 01:18:33,909 --> 01:18:36,378 ISSUES THAT -- THAT, YOU KNOW, 1702 01:18:36,378 --> 01:18:38,080 WE ALREADY DISCUSSED IS THERE IS 1703 01:18:38,080 --> 01:18:41,650 NOT ACTUALLY A BUSINESS MODEL 1704 01:18:41,650 --> 01:18:48,090 FOR THE PHARMATO -- TO REPURPOSE 1705 01:18:48,090 --> 01:18:50,893 DRUGS THAT ARE ALREADY PATENT 1706 01:18:50,893 --> 01:18:54,763 BUT MAY BE A BUSINESS MODEL OF 1707 01:18:54,763 --> 01:18:57,366 PROVING TARGET USING THESE 1708 01:18:57,366 --> 01:18:59,034 DRUGS; RIGHT? 1709 01:18:59,034 --> 01:19:01,370 SO, USING THAT, YOU KNOW, PROOF 1710 01:19:01,370 --> 01:19:03,572 OF PRINCIPLE TRIAL THAT SAYS 1711 01:19:03,572 --> 01:19:05,708 INDEED, YOU KNOW, THIS TYPE OF 1712 01:19:05,708 --> 01:19:07,543 ENGAGING THIS TYPE OF TARGET HAS 1713 01:19:07,543 --> 01:19:12,514 A POTENTIAL TO LIMIT THE 1714 01:19:12,514 --> 01:19:12,781 DISEASE. 1715 01:19:12,781 --> 01:19:15,284 THEN KIND OF OPEN IT FOR 1716 01:19:15,284 --> 01:19:17,419 PHARMATO COME UP AND DEVELOP 1717 01:19:17,419 --> 01:19:18,354 BETTER DRUGS. 1718 01:19:18,354 --> 01:19:22,224 SO, CAN YOU GUYS THINK ABOUT, 1719 01:19:22,224 --> 01:19:24,727 YOU KNOW, NON-PROFIT AND 1720 01:19:24,727 --> 01:19:25,127 GOVERNMENT? 1721 01:19:25,127 --> 01:19:31,066 WHO IS -- WOULD THERE BE A 1722 01:19:31,066 --> 01:19:32,835 SOLUTION FOR TESTING DRUGS THAT 1723 01:19:32,835 --> 01:19:38,207 MIGHT NOT HAVE ANY LONGER YOU 1724 01:19:38,207 --> 01:19:39,475 KNOW BUSINESS MODEL. 1725 01:19:39,475 --> 01:19:43,212 REALLY USING THEM FOR THIS LAST 1726 01:19:43,212 --> 01:19:45,281 STAGE OF KNOWLEDGE ACQUISITION 1727 01:19:45,281 --> 01:19:48,384 ABOUT HEALTH AND DISEASES AND 1728 01:19:48,384 --> 01:19:51,720 OPENING THAT VALIDATED TARGET 1729 01:19:51,720 --> 01:19:56,125 FOR PHARMA COMPANIES. 1730 01:19:56,125 --> 01:20:01,897 >> IF I CAN START A THING THAT 1731 01:20:01,897 --> 01:20:03,699 SOMEBODY MENTIONED EARLIER THAT 1732 01:20:03,699 --> 01:20:06,468 JUST PHARMA COMPANIES SHARING 1733 01:20:06,468 --> 01:20:08,637 ALL OF THE INFORMATION; RIGHT? 1734 01:20:08,637 --> 01:20:12,441 WHETHER DRUGS ARE SUCCESSFUL OR 1735 01:20:12,441 --> 01:20:19,081 NOT SUCCESSFUL, THE ABILITY AND 1736 01:20:19,081 --> 01:20:20,082 AVAILABILITY OF ALL THAT 1737 01:20:20,082 --> 01:20:21,750 INFORMATION COULD BE EXTREMELY 1738 01:20:21,750 --> 01:20:28,757 USEFUL TO A THIRD PARTY. 1739 01:20:28,757 --> 01:20:29,158 KRE 1740 01:20:29,158 --> 01:20:30,926 CERTAINLY, I WOULD SAY THAT THE 1741 01:20:30,926 --> 01:20:34,029 NIH HAS A VERY RESOURCE-RICH 1742 01:20:34,029 --> 01:20:35,864 ENVIRONMENT IN TERMS OF EXPERTS 1743 01:20:35,864 --> 01:20:38,400 AND PEOPLE AND COMPUTATIONAL 1744 01:20:38,400 --> 01:20:40,669 EXPERTS, ET CETERA. 1745 01:20:40,669 --> 01:20:43,472 AND, YOU KNOW, AT PHARMACEUTICAL 1746 01:20:43,472 --> 01:20:44,873 COMPANIES WE ARE SHARING PERHAPS 1747 01:20:44,873 --> 01:20:50,179 AFTER THE DRUG IS OFF PATENT 1748 01:20:50,179 --> 01:20:53,248 PERHAPS AFTER THEY FULLY 1749 01:20:53,248 --> 01:20:54,983 ADVANTED IT AND DEPOSIT 1750 01:20:54,983 --> 01:20:57,019 INFORMATION TO A THIRD PARTY 1751 01:20:57,019 --> 01:20:58,053 LOOKING AT OTHER INFORMATION AND 1752 01:20:58,053 --> 01:21:01,190 YOU WANT IT TO BE IN A SECURE 1753 01:21:01,190 --> 01:21:02,658 ENVIRONMENT THAT I THINK THAT 1754 01:21:02,658 --> 01:21:05,627 NEW DISCOVERIES COULD BE MADE 1755 01:21:05,627 --> 01:21:08,697 FROM THERE. 1756 01:21:08,697 --> 01:21:10,899 >> JUST ON TOP OF THAT IF IN 1757 01:21:10,899 --> 01:21:14,403 SOME WAYS INCENTIVIZES THAT 1758 01:21:14,403 --> 01:21:14,670 PROCESS. 1759 01:21:14,670 --> 01:21:15,337 >> ABSOLUTELY. 1760 01:21:15,337 --> 01:21:19,208 >> REGULATORY MASTER FILE AND 1761 01:21:19,208 --> 01:21:20,709 PRECLINICAL AND SAFETY DATA 1762 01:21:20,709 --> 01:21:21,944 AROUND PARTICULARLY THERE IS NOT 1763 01:21:21,944 --> 01:21:23,812 MUCH DOWNSIDE BUT IN SOME WAY TO 1764 01:21:23,812 --> 01:21:26,181 TRY TO INCENTIVIZE THAT PROCESS 1765 01:21:26,181 --> 01:21:29,017 FOR COMPANIES THAT I THINK ARE 1766 01:21:29,017 --> 01:21:32,388 ONE WAY TO FACILITATE THAT. 1767 01:21:32,388 --> 01:21:35,624 IT IS A TOUGH BOTTLENECK THAT I 1768 01:21:35,624 --> 01:21:40,195 ABSOLUTELY AGREE. 1769 01:21:40,195 --> 01:21:42,898 >> WE TALKED WITH CHRISTINE 1770 01:21:42,898 --> 01:21:43,332 BEFORE. 1771 01:21:43,332 --> 01:21:45,033 IF PEOPLE -- I -- I REALLY 1772 01:21:45,033 --> 01:21:46,401 DIDN'T KNOW A LOT OF THINGS 1773 01:21:46,401 --> 01:21:47,503 ABOUT PHARMA. 1774 01:21:47,503 --> 01:21:48,036 RIGHT? 1775 01:21:48,036 --> 01:21:50,072 IF YOU DON'T UNDERSTAND THOSE 1776 01:21:50,072 --> 01:21:52,074 REALITIES, YOU MAY COME TO VERY 1777 01:21:52,074 --> 01:21:54,243 WRONG CONCLUSIONS; RIGHT? 1778 01:21:54,243 --> 01:21:57,212 SO, YOU KNOW, THERE MAY BE 1779 01:21:57,212 --> 01:22:00,749 PEOPLE TALKING ABOUT GREED; 1780 01:22:00,749 --> 01:22:01,650 RIGHT? 1781 01:22:01,650 --> 01:22:08,056 REALITY IS IT IS DIFFICULT TO DO 1782 01:22:08,056 --> 01:22:09,725 DRUG DEVELOPMENT AND FAILURES 1783 01:22:09,725 --> 01:22:14,930 ARE COSTLY THAT IT CAN BASICALLY 1784 01:22:14,930 --> 01:22:16,231 TEACH ANY SMALL COMPANY AND THEY 1785 01:22:16,231 --> 01:22:19,468 HAVE USUALLY ONE OR A FEW DRUGS. 1786 01:22:19,468 --> 01:22:23,105 AND, YOU KNOW, FAILURE IS REALLY 1787 01:22:23,105 --> 01:22:25,040 INCREDIBLY COSTLY. 1788 01:22:25,040 --> 01:22:27,810 AND EVEN THOUGH THEY MAY HAVE 1789 01:22:27,810 --> 01:22:31,246 COLLECTED USEFUL DATA AND INVEST 1790 01:22:31,246 --> 01:22:34,716 LOTS OF MONEY INTO DEVELOPMENT 1791 01:22:34,716 --> 01:22:39,721 OF THE DRUG AND ONCE DRUG IS 1792 01:22:39,721 --> 01:22:44,426 ABANDONED THERE IS NOT REALLY 1793 01:22:44,426 --> 01:22:46,929 ANYBODY OR ANY ENTITY THAT OWNS 1794 01:22:46,929 --> 01:22:51,567 THE HISTORY OF THE DRUG OR OWNS 1795 01:22:51,567 --> 01:22:54,803 DATA; RIGHT? 1796 01:22:54,803 --> 01:22:59,274 THAT IS PHENOMENAL WASTE OF 1797 01:22:59,274 --> 01:23:03,345 PATIENT'S PARTICIPATION AND COST 1798 01:23:03,345 --> 01:23:06,715 AND EVERYTHING. 1799 01:23:06,715 --> 01:23:09,718 NON-PROFIT ENTITY THAT WOULD 1800 01:23:09,718 --> 01:23:19,027 CURATE DATA OR I DON'T KNOW 1801 01:23:19,027 --> 01:23:21,997 REGULATORY APPROVAL AND LAW IF 1802 01:23:21,997 --> 01:23:26,501 DRUG IS ABANDONED THAT IND 1803 01:23:26,501 --> 01:23:31,607 PACKET BECOMES AVAILABLE FOR -- 1804 01:23:31,607 --> 01:23:36,111 AND CLEARLY I HEAR YOU. 1805 01:23:36,111 --> 01:23:39,481 I'M FOR WIN/WIN SOLUTIONS AND 1806 01:23:39,481 --> 01:23:41,250 BELIEVE THERE COULD BE SOLUTIONS 1807 01:23:41,250 --> 01:23:46,121 THAT ARE WIN/WIN FOR COMPANIES 1808 01:23:46,121 --> 01:23:47,522 INCENTIVIZING THE DRUG TO 1809 01:23:47,522 --> 01:23:49,424 DEPOSIT IT ACTUALLY. YOU EITHER 1810 01:23:49,424 --> 01:23:51,426 GET NOTHING OR SOMETHING BACK 1811 01:23:51,426 --> 01:23:53,028 POTENTIALLY IF THE DRUG WORKS. 1812 01:23:53,028 --> 01:23:55,564 >> I THINK SORRY GO AHEAD. 1813 01:23:55,564 --> 01:24:00,235 >> COMMON YOU MAY BE ON THE SAME 1814 01:24:00,235 --> 01:24:01,837 WAVELENGTH AND THINK THAT CARROT 1815 01:24:01,837 --> 01:24:03,505 APPROACH WILL WORKING BETTER 1816 01:24:03,505 --> 01:24:06,308 THAN A STICK AND AGREED WITH 1817 01:24:06,308 --> 01:24:09,177 COMMENT EARLIER ABOUT 1818 01:24:09,177 --> 01:24:10,712 INCENTIVIZATION AND WOULD WORK 1819 01:24:10,712 --> 01:24:13,115 BETTER THAN A SORT OF A YOU KNOW 1820 01:24:13,115 --> 01:24:14,383 A THREAT IF YOU WILL. 1821 01:24:14,383 --> 01:24:19,354 >> YES. SIMILARLY INCENTIVIZING 1822 01:24:19,354 --> 01:24:23,792 FOR RESCUER OF DRUG IN TERMS OF 1823 01:24:23,792 --> 01:24:28,263 IP AND IN UNITED STATES ALL 1824 01:24:28,263 --> 01:24:29,398 INCENTIVES GET PERVERSELY TURNED 1825 01:24:29,398 --> 01:24:33,235 AROUND AND IF YOU COULD 1826 01:24:33,235 --> 01:24:34,870 INCENTIVIZE PRESERVATION FOR IP 1827 01:24:34,870 --> 01:24:37,372 FOR THAT RESCUER ENTITY AGAIN. 1828 01:24:37,372 --> 01:24:40,475 AND FIGURING OUT HOW TO DO THAT 1829 01:24:40,475 --> 01:24:42,711 FROM A LEGAL POINT OF VIEW IS 1830 01:24:42,711 --> 01:24:46,348 EASIER SAID THAN DONE. YEAH. 1831 01:24:46,348 --> 01:24:51,353 >> YEAH. DR. BERTAGNOLLI, THE 1832 01:24:51,353 --> 01:24:55,257 NIH DIRECTOR HAD A PROVOCATIVE 1833 01:24:55,257 --> 01:24:57,926 SLIDE THAT SAID OUT OF 7,000 1834 01:24:57,926 --> 01:24:59,828 HUMAN DISEASES WE HAVE 1835 01:24:59,828 --> 01:25:06,168 TREATMENTS FOR FIVE% OF THEM. 1836 01:25:06,168 --> 01:25:08,103 IT WAS MIND BOGGLING TO ME. 1837 01:25:08,103 --> 01:25:11,807 YEAH. YOU KNOW, THERE IS -- 1838 01:25:11,807 --> 01:25:15,077 THERE IS ENORMOUS COST TO THE 1839 01:25:15,077 --> 01:25:20,315 GOVERNMENT FOR HEALTHCARE OF THE 1840 01:25:20,315 --> 01:25:30,726 UNTREATABLE DISEASES. 1841 01:25:40,002 --> 01:25:42,471 IT TOOK NIH DIRECTOR TO 1842 01:25:42,471 --> 01:25:46,908 NEGOTIATE THESE THINGS; RIGHT? 1843 01:25:46,908 --> 01:25:49,111 WE ARE VERY CAPABLE PEOPLE AND 1844 01:25:49,111 --> 01:25:51,079 SURE I WOULDN'T BE ABLE TO 1845 01:25:51,079 --> 01:25:52,848 NEGOTIATE THAT; RIGHT? 1846 01:25:52,848 --> 01:25:59,554 IT TAKES THE -- IT TAKES THE 1847 01:25:59,554 --> 01:26:03,091 LEADERSHIP THAT BASICALLY 1848 01:26:03,091 --> 01:26:06,561 LEADERSHIP HAS TO BUY INTO THE 1849 01:26:06,561 --> 01:26:10,999 IDEA THAT THIS IS IMPORTANT FOR 1850 01:26:10,999 --> 01:26:13,502 SOCIETY AND HEALTHCARE AND 1851 01:26:13,502 --> 01:26:16,772 FINDING WIN/WIN SOLUTION THAT WE 1852 01:26:16,772 --> 01:26:19,875 ARE BOTH FOR GOVERNMENT AND 1853 01:26:19,875 --> 01:26:23,745 TAXPAYERS AND PHARMAINDUSTRY AND 1854 01:26:23,745 --> 01:26:31,820 ONE OTHER QUESTION WE WERE 1855 01:26:31,820 --> 01:26:33,755 DISCUSSING IS TO SKOOSH SECURE 1856 01:26:33,755 --> 01:26:37,692 IP RIGHTS; RIGHT? 1857 01:26:37,692 --> 01:26:40,595 THERE IS SO MUCH IN LITERATURE 1858 01:26:40,595 --> 01:26:44,900 AND THERE HAS BEEN DUE TOOMICS 1859 01:26:44,900 --> 01:26:47,803 TECHNOLOGIES AND DUE TO THESE 1860 01:26:47,803 --> 01:26:51,606 INSILICO STUDIES, THERE REALLY 1861 01:26:51,606 --> 01:26:58,613 IS ALMOST EVERY MONTH YOU FIND 1862 01:26:58,613 --> 01:27:01,283 INSILICO STUDY WITH BIOFORMATIC 1863 01:27:01,283 --> 01:27:02,984 APPROACH TO TRY TO FIND DRUGS 1864 01:27:02,984 --> 01:27:06,254 FOR NEW INDICATIONS AND THERE 1865 01:27:06,254 --> 01:27:09,925 ARE THESE HUNDREDS OF DRUG 1866 01:27:09,925 --> 01:27:11,293 DISEASE MATCHES. 1867 01:27:11,293 --> 01:27:13,228 OF COURSE, VAST MAJORITY OF THEM 1868 01:27:13,228 --> 01:27:17,099 WILL NEVER BE TESTED. 1869 01:27:17,099 --> 01:27:25,073 AND IT IS EVEN DIFFICULT TO 1870 01:27:25,073 --> 01:27:28,076 PRIORITIZE AMONG THESE. 1871 01:27:28,076 --> 01:27:30,445 THEY SHOULD BE TESTED AND 1872 01:27:30,445 --> 01:27:31,980 QUESTION IS ALSO IF THESE 1873 01:27:31,980 --> 01:27:38,620 STUDIES ARE NOW IN PUBLIC DOMAIN 1874 01:27:38,620 --> 01:27:41,857 WILL THEY INFRINGE IP RIGHTS? 1875 01:27:41,857 --> 01:27:44,860 WHAT IS THE PATENT PROCESS? 1876 01:27:44,860 --> 01:27:47,662 IF YOU HAVE OR DEVELOP NOW VERY 1877 01:27:47,662 --> 01:27:51,700 STRONG IN VIVO HUMAN DATA THAT 1878 01:27:51,700 --> 01:27:54,603 SUGGESTS THAT THERE IS A TARGET 1879 01:27:54,603 --> 01:27:57,506 LINKING THE DISEASE; RIGHT? 1880 01:27:57,506 --> 01:28:00,709 AND BASED ON THAT, YOU WANT TO 1881 01:28:00,709 --> 01:28:06,281 TROO ET THAT DISEASE, WILL THE 1882 01:28:06,281 --> 01:28:08,150 EXAMINER INVALIDATE THAT PATTERN 1883 01:28:08,150 --> 01:28:12,220 BECAUSE THERE IS COMPUTATIONAL 1884 01:28:12,220 --> 01:28:15,724 STUDY ALREADY THAT SUGGESTS 1885 01:28:15,724 --> 01:28:18,894 THERE MIGHT BE THIS TARGET 1886 01:28:18,894 --> 01:28:20,795 DISEASE RELATIONSHIP? 1887 01:28:20,795 --> 01:28:25,867 DO YOU HAVE ANY IDEA ON -- ABOUT 1888 01:28:25,867 --> 01:28:32,407 THAT? 1889 01:28:32,407 --> 01:28:35,577 >> I GUESS I WILL MAYBE TAKE A 1890 01:28:35,577 --> 01:28:37,546 STAB AT IT. 1891 01:28:37,546 --> 01:28:39,548 SO, FIRST OF ALL THE MOST DATA 1892 01:28:39,548 --> 01:28:41,983 YOU WILL HAVE IS GOING TO BE FOR 1893 01:28:41,983 --> 01:28:43,585 STUFF ALREADY ON THE MARKET. 1894 01:28:43,585 --> 01:28:47,022 YOU WON'T HAVE IT SO MUCH FOFR 1895 01:28:47,022 --> 01:28:48,023 PROPRIETARY DRUGS. 1896 01:28:48,023 --> 01:28:50,926 IT IS ALREADY AN AREA THAT WILL 1897 01:28:50,926 --> 01:28:55,430 BE VERY, VERY DIFFICULT FOR THE 1898 01:28:55,430 --> 01:28:57,532 REASONS THAT I DESCRIBED. 1899 01:28:57,532 --> 01:29:00,802 THE -- YOU KNOW, YOU POTENTIALLY 1900 01:29:00,802 --> 01:29:02,604 STILL HAVE THE -- EVEN IF YOU 1901 01:29:02,604 --> 01:29:04,773 WOULDN'T GET THE PATENT, I 1902 01:29:04,773 --> 01:29:07,776 SUPPOSE YOU MIGHT STILL HAVE 1903 01:29:07,776 --> 01:29:09,211 EXCLUSIVITY GRANTED FROM FDA. 1904 01:29:09,211 --> 01:29:11,847 IF THERE ARE GENERICS ON THE 1905 01:29:11,847 --> 01:29:15,650 MARKET, IT REALLY DOESN'T DO YOU 1906 01:29:15,650 --> 01:29:16,184 GOOD. 1907 01:29:16,184 --> 01:29:18,420 AND IT HAS BEEN PROPOSED AND 1908 01:29:18,420 --> 01:29:22,824 HEARD PEOPLE PROPOSE THE IDEA OF 1909 01:29:22,824 --> 01:29:23,925 WHAT IF YOUR PRESCRIPTION HAS TO 1910 01:29:23,925 --> 01:29:31,800 BE ACTUALLY TIED TO A SPECIFIC 1911 01:29:31,800 --> 01:29:32,400 LAB 1912 01:29:32,400 --> 01:29:32,734 LABEL? 1913 01:29:32,734 --> 01:29:36,671 DANGER THERE IS WE ARE DEPENDENT 1914 01:29:36,671 --> 01:29:38,740 ON ABILITY TO PRESCRIBE LABEL 1915 01:29:38,740 --> 01:29:39,641 AND PARTICULARLY FOR RARE 1916 01:29:39,641 --> 01:29:42,244 DISEASES AND TAKING AWAY THAT 1917 01:29:42,244 --> 01:29:45,313 ABILITY IT WOULD HAVE COMPLETELY 1918 01:29:45,313 --> 01:29:46,581 OPPOSITE EFFECT WHAT YOU ARE 1919 01:29:46,581 --> 01:29:48,850 INTENDING WHEN YOU SAY YOU WANT 1920 01:29:48,850 --> 01:29:54,289 TO TIE IT TO THE -- THE LABEL. 1921 01:29:54,289 --> 01:29:55,523 SO, YEAH. 1922 01:29:55,523 --> 01:29:58,159 >> ALL RIGHT LOOKS WE HAVE 1923 01:29:58,159 --> 01:30:00,495 MANAGED TO GET TO THE END OF THE 1924 01:30:00,495 --> 01:30:00,795 SESSION. 1925 01:30:00,795 --> 01:30:02,597 THANK YOU ALL. 1926 01:30:02,597 --> 01:30:05,233 WE WILL MONITOR IF WE HAVE 1927 01:30:05,233 --> 01:30:06,501 UNANSWERED QUESTIONS. 1928 01:30:06,501 --> 01:30:08,937 I WILL TRY TO SEND THEM YOUR 1929 01:30:08,937 --> 01:30:09,137 WAY. 1930 01:30:09,137 --> 01:30:11,773 THANK YOU FOR COMING AND 1931 01:30:11,773 --> 01:30:13,241 PARTICIPATING AND HOPE THAT IT 1932 01:30:13,241 --> 01:30:16,111 WAS USEFUL FOR OUR LISTENERS. 1933 01:30:16,111 --> 01:30:16,678 THANK YOU. 1934 01:30:16,678 --> 01:30:19,281 >> THANK YOU. 1935 01:30:19,281 --> 01:30:21,716 >> THANK YOU. 1936 01:30:21,716 --> 01:30:27,589 >> SO, ON BEHALF OF NIH AND 1937 01:30:27,589 --> 01:30:29,991 FIRST INDUSTRY DAY, I WOULD LIKE 1938 01:30:29,991 --> 01:30:32,093 TO WELCOME EVERYBODY TO THE 1939 01:30:32,093 --> 01:30:33,094 DIAGNOSTICS PANEL AND THERE IS 1940 01:30:33,094 --> 01:30:35,764 THOUGHT ABOUT NIH WE STUDY 1941 01:30:35,764 --> 01:30:39,901 SIMPLY THE BASIC BIOLOGY AND 1942 01:30:39,901 --> 01:30:41,403 CHEMISTRY OF LIFE. 1943 01:30:41,403 --> 01:30:42,871 WE ACTUALLY WORK WITH A NUMBER 1944 01:30:42,871 --> 01:30:47,442 OF TECHNOLOGIES IN ADDITION TO 1945 01:30:47,442 --> 01:30:49,778 BASIC BIOLOGY AND WILL STUDY 1946 01:30:49,778 --> 01:30:52,213 THERAPEUTICS AND VACCINES AND 1947 01:30:52,213 --> 01:30:54,950 DEVICES AND WEARABLES. EHEALTH 1948 01:30:54,950 --> 01:30:59,788 AND DIGITAL HEALTH AND HAVE A 1949 01:30:59,788 --> 01:31:00,989 CONCENTRATED FOCUS ON 1950 01:31:00,989 --> 01:31:01,690 DIAGNOS 1951 01:31:01,690 --> 01:31:02,057 DIAGNOSTICS. 1952 01:31:02,057 --> 01:31:05,827 WE HAVE ASSEMBLED A STRONG PANEL 1953 01:31:05,827 --> 01:31:08,430 FROM LATER COMPANIES TO PRESENT 1954 01:31:08,430 --> 01:31:09,698 EXCITING INNOVATIONS THAT ARE 1955 01:31:09,698 --> 01:31:11,199 GOING ON IN THE FIELD. 1956 01:31:11,199 --> 01:31:15,136 SO, FIRST, WE ARE GOING TO HAVE 1957 01:31:15,136 --> 01:31:19,808 A PRESENTATION BY THE VARIOUS 1958 01:31:19,808 --> 01:31:22,344 INVESTIGATORS AND COMPANY 1959 01:31:22,344 --> 01:31:22,644 EXECUTIVES. 1960 01:31:22,644 --> 01:31:25,246 PLEASE PUT QUESTIONS IN THE 1961 01:31:25,246 --> 01:31:25,613 CHAT. 1962 01:31:25,613 --> 01:31:29,317 WE WILL GET TO THEM AND WILL 1963 01:31:29,317 --> 01:31:31,786 START OFF WITH DR. DANIELLE 1964 01:31:31,786 --> 01:31:34,756 PELLA A SENIOR INVESTIGATOR IN 1965 01:31:34,756 --> 01:31:36,658 THE LABORATORY OF BIOORGANIC 1966 01:31:36,658 --> 01:31:39,728 CHEMISTRY IN THE NATIONAL 1967 01:31:39,728 --> 01:31:43,365 INSTITUTE OF DIE BEETIS AND 1968 01:31:43,365 --> 01:31:45,467 DIGESTIVE AND KIDNEY DISORDERS. 1969 01:31:45,467 --> 01:31:48,803 >> THANK YOU VERY MUCH. 1970 01:31:48,803 --> 01:31:51,706 I WILL SHARE MY SCREEN. 1971 01:31:51,706 --> 01:31:58,380 >> OKAY. HOPEFULLY YOU CAN SEE 1972 01:31:58,380 --> 01:32:04,419 MY SCREEN AND THANK YOU FOR THE 1973 01:32:04,419 --> 01:32:11,793 INTRODUCTION TO PRESENT TO YOU 1974 01:32:11,793 --> 01:32:15,296 TOD 1975 01:32:15,296 --> 01:32:15,530 TODAY. 1976 01:32:15,530 --> 01:32:17,999 I WILL TELL YOU I'M NOT A 1977 01:32:17,999 --> 01:32:19,267 PROFESSIONAL DIAGNOSTIC 1978 01:32:19,267 --> 01:32:23,772 DEVELOPER BUT REALLY MOSTLY AN 1979 01:32:23,772 --> 01:32:26,608 ORGANIC CHEMIST AND INTEREST IN 1980 01:32:26,608 --> 01:32:29,244 MOLECULE CALLED PEPTIDE NUCLEIC 1981 01:32:29,244 --> 01:32:31,780 ACID I WILL TELL YOU ABOUT TODAY 1982 01:32:31,780 --> 01:32:33,715 AND FUNDAMENTAL INTEREST IN THIS 1983 01:32:33,715 --> 01:32:35,316 LED DOWN THE ROAD TO AN INTEREST 1984 01:32:35,316 --> 01:32:36,885 IN TRANSLATION THAT IS 1985 01:32:36,885 --> 01:32:39,721 SPECIFICALLY FOR DOING HIV 1986 01:32:39,721 --> 01:32:42,490 DIAGNOSTICS LEADING TO CREATIVE 1987 01:32:42,490 --> 01:32:44,592 PARTNER CALLS ULTRA TECH AND 1988 01:32:44,592 --> 01:32:50,432 LOTS OF THE WORK IS FOCUSED BY 1989 01:32:50,432 --> 01:32:51,699 OFFICE OF AIDS INSTITUTE AND 1990 01:32:51,699 --> 01:32:53,168 RESEARCH AND STARTING OFF SAYING 1991 01:32:53,168 --> 01:32:55,236 A BIT ABOUT THE IMPORTANCE OF 1992 01:32:55,236 --> 01:32:57,639 DIAGNOSTICS IN THE REALM OF HIV 1993 01:32:57,639 --> 01:32:59,808 THAT IS ESSENTIAL TO FIGURE OUT 1994 01:32:59,808 --> 01:33:02,043 THE VIRUS AND WHO HAS IT OR 1995 01:33:02,043 --> 01:33:06,080 DOESN'T AND WILL HELP SPREAD THE 1996 01:33:06,080 --> 01:33:08,716 VIRUS IDEALLY AND PHYSICIANS 1997 01:33:08,716 --> 01:33:10,285 NEED THIS TO DECIDE WHAT 1998 01:33:10,285 --> 01:33:11,886 TREATMENT AND WHO WILL NEED 1999 01:33:11,886 --> 01:33:14,889 MEDICATIONS AND HIV TESTING 2000 01:33:14,889 --> 01:33:15,857 INVOLVES RAPID DETECTIONS THAT 2001 01:33:15,857 --> 01:33:21,095 IS USUALLY LOOKING FOR HIV VIRAL 2002 01:33:21,095 --> 01:33:23,665 ANTIGENS AND RAPID TESTS REQUIRE 2003 01:33:23,665 --> 01:33:26,601 FOLLOW UP TESTING AND HIV GOLD 2004 01:33:26,601 --> 01:33:29,471 STANDARD TO CONFIRM INFECTION IS 2005 01:33:29,471 --> 01:33:33,608 NUCLEIC ACID BASED TEST THAT 2006 01:33:33,608 --> 01:33:36,411 SIGNALS PRESENCE OF HRNA AND 2007 01:33:36,411 --> 01:33:39,147 AFTER HIV INFECTION IS CONFIRMED 2008 01:33:39,147 --> 01:33:40,582 DIAGNOSTICS ARE REQUIRED FOR THE 2009 01:33:40,582 --> 01:33:42,984 PATIENT FOR THE REST OF THE 2010 01:33:42,984 --> 01:33:44,285 PATIENT'S COURSE OF TREATMENT 2011 01:33:44,285 --> 01:33:46,654 AND REST OF THEIR LIFE AND 2012 01:33:46,654 --> 01:33:48,823 ROUTINE DIAGNOSTIC TESTING IS 2013 01:33:48,823 --> 01:33:51,726 ESSENTIAL IN WHAT IS HIV VIRAL 2014 01:33:51,726 --> 01:33:56,097 LOAD MONITORING THAT MEASURES 2015 01:33:56,097 --> 01:33:59,701 LEVELS OF HIV RNA IN INFECTED 2016 01:33:59,701 --> 01:34:00,935 INDIVIDUAL AND WHEN TO START 2017 01:34:00,935 --> 01:34:02,470 TREATMENT AND MAKE SURE THAT 2018 01:34:02,470 --> 01:34:03,271 MEDICATIONS ARE WORKING 2019 01:34:03,271 --> 01:34:05,373 CORRECTLY AND TARGET OF THE TEST 2020 01:34:05,373 --> 01:34:08,810 IS LOW AND IDEALLY VIRAL LOAD OF 2021 01:34:08,810 --> 01:34:12,580 100 COPIES OF M MILLIMETER OF 2022 01:34:12,580 --> 01:34:14,649 PLASMA OR LESS IS IDEAL AND 2023 01:34:14,649 --> 01:34:17,785 PHYSICIANS NEED TO KNOW IF 2024 01:34:17,785 --> 01:34:18,987 INCREASES IN VIRAL LOAD TO 2025 01:34:18,987 --> 01:34:21,523 INDICATE DEVELOPING RESISTANCE 2026 01:34:21,523 --> 01:34:23,958 TO CURRENT SIGNALING MEDICATIONS 2027 01:34:23,958 --> 01:34:27,695 NEED TO BE CHANGED TO SOMETHING 2028 01:34:27,695 --> 01:34:32,734 EL 2029 01:34:32,734 --> 01:34:32,934 ELSE. 2030 01:34:32,934 --> 01:34:35,803 THERE ARE MANY EXAMPLES OF USING 2031 01:34:35,803 --> 01:34:39,707 THIS TEST SUCCESSFULLY AND IN 2032 01:34:39,707 --> 01:34:44,412 WEALTHIER NATIONS SUCH AS OURS 2033 01:34:44,412 --> 01:34:46,881 AND DETECTION AND DIAGNOSIS AND 2034 01:34:46,881 --> 01:34:49,551 VIRAL MONITORING AND CHALLENGING 2035 01:34:49,551 --> 01:34:52,654 TO IMPLEMENT INTO RESOURCE 2036 01:34:52,654 --> 01:35:03,197 MONITORING SETTINGS AND NEED IS 2037 01:35:03,765 --> 01:35:06,234 GREAT 2038 01:35:06,234 --> 01:35:06,501 GREATEST. 2039 01:35:06,501 --> 01:35:08,436 MY RESOURCE GOAL WAS TO SEE IF 2040 01:35:08,436 --> 01:35:10,772 WE COULD TAKE AN APPROACH FOR 2041 01:35:10,772 --> 01:35:14,576 TESTING FOR HIVRNA AND MOVE IT 2042 01:35:14,576 --> 01:35:15,877 CLOSER TO PATIENT POINT OF CARE 2043 01:35:15,877 --> 01:35:19,113 AND CHALLENGE TO AVOID USING 2044 01:35:19,113 --> 01:35:22,850 TYPICAL AMPLIFICATION STRATEGIES 2045 01:35:22,850 --> 01:35:27,722 USING PRELIM RACES AND RESEARCH 2046 01:35:27,722 --> 01:35:29,557 IS GEARED FOR CHEMISTRY AND 2047 01:35:29,557 --> 01:35:32,293 UNDERSTANDING OF MOLECULES 2048 01:35:32,293 --> 01:35:35,863 CALLED PEPTIDE NUCLEIC ACIDS AND 2049 01:35:35,863 --> 01:35:37,699 MOLECULES COULD BE BENEFICIAL IN 2050 01:35:37,699 --> 01:35:42,036 THIS LANDSCAPE AND TELLING YOU 2051 01:35:42,036 --> 01:35:44,906 ABOUT PEPTIDE NUCLEIC ACID AND 2052 01:35:44,906 --> 01:35:46,641 BASIC STRUCTURE OF MOLECULE IS 2053 01:35:46,641 --> 01:35:49,143 SHOWN HERE AND IT FEATURES A 2054 01:35:49,143 --> 01:35:52,547 BACKBONE THAT IS NOT A NATURALLY 2055 01:35:52,547 --> 01:35:54,349 OCCURRING BACKBONE BUT ONE MADE 2056 01:35:54,349 --> 01:35:56,818 IN THE LAB ATTACHED IN BACKBONE 2057 01:35:56,818 --> 01:36:00,722 ARE NUCLEAR BASIS OF DNA AND 2058 01:36:00,722 --> 01:36:02,256 SYNTHETIC MOLECULES WE MAKE 2059 01:36:02,256 --> 01:36:03,725 USING CHEMICAL METHODS THAT 2060 01:36:03,725 --> 01:36:05,960 DON'T OCCUR IN NATURE AND 2061 01:36:05,960 --> 01:36:08,830 SEQUENCE OF NUCLEOTIDES WE CAN 2062 01:36:08,830 --> 01:36:10,365 MAKE LONGER IF NEEDED. 2063 01:36:10,365 --> 01:36:13,101 WHAT IS FASCINATING ABOUT 2064 01:36:13,101 --> 01:36:15,203 MOLECULES IS THEY BIND TO 2065 01:36:15,203 --> 01:36:17,939 SEQUENCES WELL AND MOLECULE 2066 01:36:17,939 --> 01:36:19,741 EXPOSED TO COMPLEMENTARY DNA 2067 01:36:19,741 --> 01:36:21,376 WILL BIND AND HAVE A NICE 2068 01:36:21,376 --> 01:36:23,344 MELTING TEMPERATURE TO BE 2069 01:36:23,344 --> 01:36:24,212 CHARACTERIZED. 2070 01:36:24,212 --> 01:36:29,384 PNA IS A FASCINATING MOLECULE. 2071 01:36:29,384 --> 01:36:33,721 IT OFTEN BINDS STRONGLY THAN 2072 01:36:33,721 --> 01:36:35,089 COMPLIMENTARY NUCLEOTIDES ITSELF 2073 01:36:35,089 --> 01:36:37,892 AND IS FASCINATING PNA DOESN'T 2074 01:36:37,892 --> 01:36:40,628 EXIST NATURALLY AND CAN'T BE 2075 01:36:40,628 --> 01:36:45,066 DEGRADED BY PRO TEASES OR 2076 01:36:45,066 --> 01:36:48,603 NUCLEASES AND DETECTION DEVICES 2077 01:36:48,603 --> 01:36:50,405 IS SHELF STABLE PART OF 2078 01:36:50,405 --> 01:36:51,606 MOTIVATION MOVING THIS FORWARD 2079 01:36:51,606 --> 01:36:55,777 AND SETTING IT UP DETECTING HIV 2080 01:36:55,777 --> 01:37:00,548 RNA AND DEVELOPING SYSTEM USING 2081 01:37:00,548 --> 01:37:02,717 ELIZA PROTOCOLS AND STARTING OFF 2082 01:37:02,717 --> 01:37:05,987 WITH A SEQUENCE OF HIV VIRUS AND 2083 01:37:05,987 --> 01:37:09,257 SEQUENCE IS SHOWN HERE 27 BASIS 2084 01:37:09,257 --> 01:37:14,095 AND MADE 2PNAS COMPLEMENTARY TO 2085 01:37:14,095 --> 01:37:15,363 ADJACENT REGIONS. 2086 01:37:15,363 --> 01:37:19,133 ONE IS COLOR CODED IN BLUE AND 2087 01:37:19,133 --> 01:37:21,169 IN GREEN AND ASSAY ATTACHING 2088 01:37:21,169 --> 01:37:25,540 GREEN PNA AND USING COVALENT 2089 01:37:25,540 --> 01:37:26,874 ATTACHMENT CHEMISTRY AND FREE 2090 01:37:26,874 --> 01:37:27,909 SOLUTION TO [INDISCERNIBLE] AND 2091 01:37:27,909 --> 01:37:32,413 HAS A BIOTIN GROUP AND IDEA HERE 2092 01:37:32,413 --> 01:37:35,850 PRESENCE OF HIV RNAPNAS WOULD 2093 01:37:35,850 --> 01:37:40,321 ADHERE TO PROSPECTIVE SEQUENCES 2094 01:37:40,321 --> 01:37:42,757 PERFORM ONES SURFACE AND HELD 2095 01:37:42,757 --> 01:37:45,460 TOGETHER WITH HYDROGEN BONDING 2096 01:37:45,460 --> 01:37:49,030 AND TAKE ADVANTAGE OF STANDARD 2097 01:37:49,030 --> 01:37:51,065 ELIZA REAGENTS AND IN PARTICULAR 2098 01:37:51,065 --> 01:37:53,367 THIS COMBINATION WITH CONJUGATES 2099 01:37:53,367 --> 01:37:57,405 WAS COMMERCIALLY AVAILABLE 2100 01:37:57,405 --> 01:37:59,607 BINDING TO BIOTIN ON THE SURFACE 2101 01:37:59,607 --> 01:38:02,443 AND SUBSTRATE FOR THE ENZYMES TO 2102 01:38:02,443 --> 01:38:03,711 DEVELOP A NEGATIVE COLOR IN 2103 01:38:03,711 --> 01:38:06,214 WELLS THAT YOU ARE SEEING HERE 2104 01:38:06,214 --> 01:38:08,015 INDICATING PRESENCE OF HIV AND 2105 01:38:08,015 --> 01:38:09,851 FOR NONPRESENCE OF HIV. 2106 01:38:09,851 --> 01:38:13,654 WE SET IT UP AND PNA WORKED AND 2107 01:38:13,654 --> 01:38:15,590 DETECTION LIMIT WAS NOT SO GOOD 2108 01:38:15,590 --> 01:38:18,626 AND GETTING LIMIT MUCH LOWER TO 2109 01:38:18,626 --> 01:38:21,095 BE CLOSE TO BEING CLINICALLY 2110 01:38:21,095 --> 01:38:22,764 RELEVANT AND HAD IDEAS TO DO 2111 01:38:22,764 --> 01:38:25,967 THIS AND RESEARCH FOR YEARS 2112 01:38:25,967 --> 01:38:28,302 LOOKED AT CHEMICAL BACKBONE 2113 01:38:28,302 --> 01:38:31,105 PROPERTIES OF NUCLEIC ACIDS AND 2114 01:38:31,105 --> 01:38:34,375 HAVE BEEN INTERESTED IN 2115 01:38:34,375 --> 01:38:35,543 INCORPORATING GROUPS LOOKING 2116 01:38:35,543 --> 01:38:39,013 LIKE THIS WITH SPECIFIC 2117 01:38:39,013 --> 01:38:40,848 STEREOCHEMISTRY WITH TWO AMEANS 2118 01:38:40,848 --> 01:38:42,550 COMING OFF THE RING AND FIND 2119 01:38:42,550 --> 01:38:44,285 THAT BINDING PROPERTIES WORK 2120 01:38:44,285 --> 01:38:47,822 BETTER AND THIS EXAMPLE HAS 2121 01:38:47,822 --> 01:38:49,824 THREE CYCLOPENTAINS IN THE 2122 01:38:49,824 --> 01:38:52,393 BACKBONE COMPARED TO ITS 2123 01:38:52,393 --> 01:38:54,395 PREDECESSOR THAT HAS NO 2124 01:38:54,395 --> 01:38:56,564 CYCLOPENTAINS THAT IS BETTER AND 2125 01:38:56,564 --> 01:38:59,200 SHOWING IT MUCH FURTHER AND THIS 2126 01:38:59,200 --> 01:39:01,135 EXAMPLE HAS CYCLOPENTAINS AT 2127 01:39:01,135 --> 01:39:03,638 EVERY POSITION AND IT IS 2128 01:39:03,638 --> 01:39:05,807 INCREASED 50 DEGREES COMPARED TO 2129 01:39:05,807 --> 01:39:09,577 THE ANALOG WITHOUT CRICOPEN TEEN 2130 01:39:09,577 --> 01:39:13,080 IN THE BACKBONE AND USING 2131 01:39:13,080 --> 01:39:14,348 STRATEGY EFFECTIVELY TO EFFECT 2132 01:39:14,348 --> 01:39:15,683 BINDING IN THE SYSTEM AND GOING 2133 01:39:15,683 --> 01:39:22,190 TO BASIC IDEA INCORPORATING 2134 01:39:22,190 --> 01:39:23,524 CYCLOPENTAINS IN HERE GOING FROM 2135 01:39:23,524 --> 01:39:26,294 0 TO 4 CAN INCREASE BINDING OF 2136 01:39:26,294 --> 01:39:28,863 GREEN PNA TO RESPECTIVE RNA 2137 01:39:28,863 --> 01:39:31,165 TARGET HELPING TO IMPROVE SIGNAL 2138 01:39:31,165 --> 01:39:34,468 BY HOLDING NUCLEIC ACID ON 2139 01:39:34,468 --> 01:39:36,604 SURFACE BETTER AND SOLUTION PNA 2140 01:39:36,604 --> 01:39:38,773 FIND ADDING BIOTINS TO THE END 2141 01:39:38,773 --> 01:39:43,811 IS HELPFUL FOR IMPROVING SIGNAL 2142 01:39:43,811 --> 01:39:45,713 AND MULTIVAILIENT FASHION IS 2143 01:39:45,713 --> 01:39:46,914 SHOWN HERE AND THOSE TOGETHER 2144 01:39:46,914 --> 01:39:49,317 HELP TO IMPROVE SIGNAL 2145 01:39:49,317 --> 01:39:50,351 SUBSTANTIALLY AND CARRY THIS 2146 01:39:50,351 --> 01:39:52,620 WITH OPTIMIZED SYSTEM ABLE TO 2147 01:39:52,620 --> 01:39:55,490 WORK WITH NIH TESTING HANDFUL OF 2148 01:39:55,490 --> 01:39:58,492 CLINICAL PATIENT SAMPLES WITH 2149 01:39:58,492 --> 01:40:00,895 VARIETY OF VIRAL LOADS 2150 01:40:00,895 --> 01:40:02,697 PHOTOGRAPH OF 96 WELL PLATE WITH 2151 01:40:02,697 --> 01:40:05,733 PATIENT SAMPLES SEEING NICE 2152 01:40:05,733 --> 01:40:08,936 RANGE WITH COLOR AND TESTING 2153 01:40:08,936 --> 01:40:10,071 SIMULTANEOUSLY WITH SYSTEM AND 2154 01:40:10,071 --> 01:40:11,839 [INDISCERNIBLE] SYSTEMS SHOWN 2155 01:40:11,839 --> 01:40:14,609 HERE AND QUANTIFYING VIRAL LOADS 2156 01:40:14,609 --> 01:40:17,044 AND CORRELATE THAT WITH 2157 01:40:17,044 --> 01:40:18,613 ABSORBANCE WE GET FROM OUR 2158 01:40:18,613 --> 01:40:20,348 METHOD AND IN HUNDREDS OF COPIES 2159 01:40:20,348 --> 01:40:22,450 THAT IS A CLINICALLY RELEVANT 2160 01:40:22,450 --> 01:40:25,119 RANGE AND NICE AND PUBLISHED AND 2161 01:40:25,119 --> 01:40:26,921 PATENTED AND THOUGHT IT WOULD BE 2162 01:40:26,921 --> 01:40:30,825 GOOD FOR TRANSLATION AND WANTED 2163 01:40:30,825 --> 01:40:33,761 TO WORK WITH COMBINASE TO 2164 01:40:33,761 --> 01:40:35,096 TRANSLATE THIS AND DIFFICULTY 2165 01:40:35,096 --> 01:40:37,732 CAME IN AND I'M A PRINCIPLE 2166 01:40:37,732 --> 01:40:39,600 INVESTIGATOR AND WORK IN A LAB 2167 01:40:39,600 --> 01:40:41,435 AND FAMILIAR WITH LABORATORY 2168 01:40:41,435 --> 01:40:44,839 TECHNIQUES AND CHEMISTRY AND 2169 01:40:44,839 --> 01:40:45,406 COMPOSITION WITH COMPANIES 2170 01:40:45,406 --> 01:40:47,441 BECAME CLEAR THAT FORMAT WASN'T 2171 01:40:47,441 --> 01:40:48,609 SUITABLE FOR ANYTHING THAT COULD 2172 01:40:48,609 --> 01:40:50,912 BE DEVELOPED WHERE WE WANTED TO 2173 01:40:50,912 --> 01:40:52,747 GO IN TRANSLATION SPHERE AND 2174 01:40:52,747 --> 01:40:54,749 ENZYMES WE ARE USING ARE NOT 2175 01:40:54,749 --> 01:40:56,417 DESIRABLE AND WEAK POINT IN 2176 01:40:56,417 --> 01:40:58,653 ASSAY AND THEY CAN HAVE SOME 2177 01:40:58,653 --> 01:40:59,587 CHALLENGES WITH WORKING. 2178 01:40:59,587 --> 01:41:03,758 THE OTHER THING THAT WAS A REAL 2179 01:41:03,758 --> 01:41:06,661 CHALLENGE TO ELIMINATE IS GET 2180 01:41:06,661 --> 01:41:09,163 RID OF PIPETTING AND PIPETTING 2181 01:41:09,163 --> 01:41:13,668 STEPS ARE LABORIOUS AND WORKING 2182 01:41:13,668 --> 01:41:15,469 TO ELIMINATE NEED FOR PIPETTING 2183 01:41:15,469 --> 01:41:16,537 AND SIGNAL SHOULD BE SOMETHING 2184 01:41:16,537 --> 01:41:18,973 TO BE CONVERTED TO A DIGITAL 2185 01:41:18,973 --> 01:41:21,676 READ OUT AND AFTER ALL THIS I 2186 01:41:21,676 --> 01:41:23,244 DESCENDED INTO TALKING WITH A 2187 01:41:23,244 --> 01:41:25,046 NUMBER OF COMPANIES AND TALKED 2188 01:41:25,046 --> 01:41:27,448 TO A LOT OF DIFFERENT PEOPLE AND 2189 01:41:27,448 --> 01:41:29,750 IDEAS AND ONE THAT HAS 2190 01:41:29,750 --> 01:41:31,652 TRANSLATED FORWARD IS ONE WITH 2191 01:41:31,652 --> 01:41:32,720 COMPANY CALLED ULTRA TECH AND 2192 01:41:32,720 --> 01:41:36,991 THEY ARE LOCATED IN IRELAND AND 2193 01:41:36,991 --> 01:41:40,728 I WILL SHOW GENERIC SLIDES WHERE 2194 01:41:40,728 --> 01:41:43,664 THEY ARE HEADED WITH THIS ASSAY 2195 01:41:43,664 --> 01:41:44,198 AND NOW. 2196 01:41:44,198 --> 01:41:47,902 WITH METHODS THEY WENT AND USED 2197 01:41:47,902 --> 01:41:50,037 RPNAS WITH CYCLO PENTAINS TO PUT 2198 01:41:50,037 --> 01:41:53,541 THEM ON DIFFERENT TYPES OF BEADS 2199 01:41:53,541 --> 01:41:56,243 TO ALLOW MOLECULES TO BE 2200 01:41:56,243 --> 01:41:57,745 EXTRACTED FROM BIOLOGICAL 2201 01:41:57,745 --> 01:41:58,412 SOLUTIONS. 2202 01:41:58,412 --> 01:42:01,315 THIS IS ALSO COMBINED WITH 2203 01:42:01,315 --> 01:42:02,783 DIFFERENT CODED MICROPARTICLES 2204 01:42:02,783 --> 01:42:06,187 AND ALLOW COMPLEXES WITH THE 2205 01:42:06,187 --> 01:42:08,856 ACTUAL ANOLITE TO BE TRANSPORTED 2206 01:42:08,856 --> 01:42:11,792 IN A DEVICE AND ULTRA TECH HAS A 2207 01:42:11,792 --> 01:42:15,196 LOT OF EXPERTISE IN MICROCHIP 2208 01:42:15,196 --> 01:42:18,032 ARENA THAT IS GOOD AT 2209 01:42:18,032 --> 01:42:19,834 MANUFACTURING MICROCHIPS WITH 2210 01:42:19,834 --> 01:42:23,437 SPECIFIC MICROCHIP WITH C MOSS 2211 01:42:23,437 --> 01:42:24,872 SILICON CHIP THEY ENGINEERED 2212 01:42:24,872 --> 01:42:27,475 THAT WILL BE ITEM THAT DETECTS 2213 01:42:27,475 --> 01:42:30,878 AND QUANTIFIES NUCLEIC ACID IN 2214 01:42:30,878 --> 01:42:33,214 ORIGINAL SAMPLE AND DETAILS 2215 01:42:33,214 --> 01:42:35,850 SYNTHETIC PNA PROBES THAT ARE 2216 01:42:35,850 --> 01:42:38,052 DESIGNED ARE REPRESENTED BY 2217 01:42:38,052 --> 01:42:40,221 KEYCHAIN PNA PROBES THAT ARE 2218 01:42:40,221 --> 01:42:42,723 SPECIAL PNAS ONE SIDE OF THEM 2219 01:42:42,723 --> 01:42:45,760 SHOWN IN BLUE HERE IS ABLE TO 2220 01:42:45,760 --> 01:42:47,828 RECOGNIZE TARGET RNA AND OTHER 2221 01:42:47,828 --> 01:42:49,530 PART HERE FREE IN THIS DEPICTION 2222 01:42:49,530 --> 01:42:52,333 IS ACTUALLY THE PART THAT BINDS 2223 01:42:52,333 --> 01:42:54,468 TO A CODED BEAD THAT THEN ALLOWS 2224 01:42:54,468 --> 01:42:58,105 THE SAMPLE TO BE TRANSPORTED AND 2225 01:42:58,105 --> 01:43:03,344 MIXED AROUND AND SEC SLIDE PNA 2226 01:43:03,344 --> 01:43:05,279 KEYCHAIN IS BOUND TO 2227 01:43:05,279 --> 01:43:06,414 COMPLEMENTARY STRAND ON THE BEAD 2228 01:43:06,414 --> 01:43:08,949 THAT IS TRANSPORTED TO SURFACE 2229 01:43:08,949 --> 01:43:10,751 OF CHIP THAT IS SPECIALLY 2230 01:43:10,751 --> 01:43:14,488 DESIGNED SO SIGNALS ARE DIRECTLY 2231 01:43:14,488 --> 01:43:17,324 READ THAT TRANSLATES TO INSTANT 2232 01:43:17,324 --> 01:43:19,360 ELECTRONIC SIGNAL AND EXAMPLE TO 2233 01:43:19,360 --> 01:43:22,663 REMOVE TYPICAL TYPES OF 2234 01:43:22,663 --> 01:43:24,298 BIOLOGICAL AMPLIFICATION AS MUCH 2235 01:43:24,298 --> 01:43:26,400 AS WE CAN AND FOCUS ON 2236 01:43:26,400 --> 01:43:28,402 ELECTRONIC AND COMPLETELY 2237 01:43:28,402 --> 01:43:30,304 SYNTHETIC SYSTEM FOR GENERATING 2238 01:43:30,304 --> 01:43:32,073 AN ACTUAL SIGNAL AND TARGETS FOR 2239 01:43:32,073 --> 01:43:42,583 THIS ARE HIV AND OTHER VIRAL 2240 01:43:42,817 --> 01:43:43,417 INFECTIN 2241 01:43:43,417 --> 01:43:45,886 -- WHAT A DEVICE WOULD LOOK LIKE 2242 01:43:45,886 --> 01:43:48,389 CALLED UBE HEALTH AND THERE IS 2243 01:43:48,389 --> 01:43:49,790 NO PRODUCT AVAILABLE CURRENTLY 2244 01:43:49,790 --> 01:43:52,626 AND GOAL IS TO HAVE SINGLE USE 2245 01:43:52,626 --> 01:43:55,262 PRODUCT TO GET SOMETHING TO BE 2246 01:43:55,262 --> 01:43:57,098 TESTED. 2247 01:43:57,098 --> 01:43:59,834 FEELING IS THIS IS ACHIEVABLE IN 2248 01:43:59,834 --> 01:44:02,837 THE NEAR FUTURE AND 2249 01:44:02,837 --> 01:44:06,073 ACKNOWLEDGING LAB AND SMALL LAB 2250 01:44:06,073 --> 01:44:07,775 MOSTLY POST DOCS AND POST 2251 01:44:07,775 --> 01:44:09,543 BACKAND WOULD LIKE TO SUPPORT 2252 01:44:09,543 --> 01:44:12,913 WHAT TRANSLATION I CAN AND ENJOY 2253 01:44:12,913 --> 01:44:17,017 WORKING WITH ULTRA TECH WITH 2254 01:44:17,017 --> 01:44:18,819 BRIAN AND TIM AND LEARNING AS 2255 01:44:18,819 --> 01:44:20,955 MUCH AS I CAN ABOUT ADVANCING 2256 01:44:20,955 --> 01:44:23,824 DIAGNOSTIC SYSTEMS AND 2257 01:44:23,824 --> 01:44:25,559 ACKNOWLEDGING INTRAMURAL PROGRAM 2258 01:44:25,559 --> 01:44:27,762 AND OFFICE OF AIDS RESEARCH TO 2259 01:44:27,762 --> 01:44:30,664 LET ME STEP OUT OF COMFORT ZONE 2260 01:44:30,664 --> 01:44:32,867 OF CHEMISTRY AND EXPLORE THIS 2261 01:44:32,867 --> 01:44:35,870 TRANSLATIONAL SPACE. 2262 01:44:35,870 --> 01:44:41,308 THANK YOU. 2263 01:44:41,308 --> 01:44:43,310 >> THANK YOU VERY MUCH. 2264 01:44:43,310 --> 01:44:46,413 REMINDER TO THE AUDIENCE TO MEEZ 2265 01:44:46,413 --> 01:44:48,149 CONVEY QUESTIONS THAT WE WOULD 2266 01:44:48,149 --> 01:44:49,950 BE HAPPY TO ASK. 2267 01:44:49,950 --> 01:44:53,754 I HAVE ONE QUICK QUESTION. 2268 01:44:53,754 --> 01:44:55,489 IT IS FOR DR. PELA WHILE WAITING 2269 01:44:55,489 --> 01:44:57,458 FOR OTHERS AND IF WE DON'T GET 2270 01:44:57,458 --> 01:44:59,160 MORE WE WILL MOVE ON AND HAVE 2271 01:44:59,160 --> 01:45:01,629 TIME, BY THE WAY, AT THE END OF 2272 01:45:01,629 --> 01:45:03,631 ALL OF THE PRESENTATIONS. 2273 01:45:03,631 --> 01:45:05,132 PLEASE GET YOUR QUESTIONS IN. 2274 01:45:05,132 --> 01:45:08,636 YOU ARE NOT OUT OF LUCK IF YOU 2275 01:45:08,636 --> 01:45:11,172 DON'T DO IT WHEN THE SPEAKER HAS 2276 01:45:11,172 --> 01:45:11,505 FINISHED. 2277 01:45:11,505 --> 01:45:13,807 IF YOU CAN COMMENT ON THE 2278 01:45:13,807 --> 01:45:15,910 SUCCESS STORY YOU SHOWED ABOUT 2279 01:45:15,910 --> 01:45:18,712 THE IMPORTANCE OF COMMERCIAL 2280 01:45:18,712 --> 01:45:22,550 DEVELOPMENT AND INPUT EXPERTISE 2281 01:45:22,550 --> 01:45:24,852 THAT WORKING WITH THE COMPANY 2282 01:45:24,852 --> 01:45:27,354 PARTNER BRINGS TO, YOU KNOW, 2283 01:45:27,354 --> 01:45:30,457 BENCH RESEARCHERS VERY 2284 01:45:30,457 --> 01:45:31,592 RESPECTFULLY SUCH AS YOURSELF. 2285 01:45:31,592 --> 01:45:34,094 >> SURE. I THINK THAT WORKING 2286 01:45:34,094 --> 01:45:36,764 IN A LAB WE HAVE OUR OWN VISIONS 2287 01:45:36,764 --> 01:45:39,466 HOW THINGS WORK ON THE BENCH. 2288 01:45:39,466 --> 01:45:42,469 WE ALL HAVE OUR SORT OF COMFORT 2289 01:45:42,469 --> 01:45:43,838 ZONE WITH DIFFERENT TECHNIQUES. 2290 01:45:43,838 --> 01:45:46,807 WHEN IT COMES TO ACTUALLY MOVING 2291 01:45:46,807 --> 01:45:52,279 A PRODUCT INTO THE REAL WORLD 2292 01:45:52,279 --> 01:45:54,348 SPACE, IT IS ANOTHER WORLD THAT 2293 01:45:54,348 --> 01:45:56,217 IS A COMPLETELY DIFFERENT WORLD 2294 01:45:56,217 --> 01:45:58,919 AND ONE I ABSORB SLOWLY THROUGH 2295 01:45:58,919 --> 01:45:59,753 TALKING WITH THE DIFFERENT 2296 01:45:59,753 --> 01:46:02,022 COMMERCIAL PARTNERS AS WELL. 2297 01:46:02,022 --> 01:46:03,958 I WILL ALSO SAY THAT ONE OF THE 2298 01:46:03,958 --> 01:46:05,559 INTERESTING THINGS IS TALKING 2299 01:46:05,559 --> 01:46:06,961 WITH A NUMBER OF DIFFERENT 2300 01:46:06,961 --> 01:46:08,796 COMPANIES AS I GO THROUGH THE 2301 01:46:08,796 --> 01:46:10,164 PROCESS AND THINK THAT EVERY 2302 01:46:10,164 --> 01:46:13,067 COMPANY HAS A VERY DIFFERENT 2303 01:46:13,067 --> 01:46:16,070 TYPE OF APPROACH. 2304 01:46:16,070 --> 01:46:17,504 IT BECAME CLEAR CERTAIN 2305 01:46:17,504 --> 01:46:18,906 APPROACHES WOULDN'T WORK WITH ME 2306 01:46:18,906 --> 01:46:20,374 AND WHERE I AM I GUESS. 2307 01:46:20,374 --> 01:46:22,977 I LIKE MORE RADICAL APPROACHES 2308 01:46:22,977 --> 01:46:24,678 WHICH IS WHERE ULTRA TECH IS 2309 01:46:24,678 --> 01:46:27,514 TAKING THINGS AND WE SEEM TO 2310 01:46:27,514 --> 01:46:28,215 WORK WELL TOGETHER. 2311 01:46:28,215 --> 01:46:30,884 I THINK THAT IT IS A HIGH RISK 2312 01:46:30,884 --> 01:46:34,555 PROJECT THAT THEY ARE TRYING TO 2313 01:46:34,555 --> 01:46:36,257 TAKE ON. 2314 01:46:36,257 --> 01:46:38,659 I AM HAPPY TO SUPPORT THEM. 2315 01:46:38,659 --> 01:46:40,861 THEY SEEM TO WORK WELL WITH ME. 2316 01:46:40,861 --> 01:46:42,563 HAVING COMMERCIAL INSIGHT I 2317 01:46:42,563 --> 01:46:44,765 THINK IS GREAT HONESTLY AND 2318 01:46:44,765 --> 01:46:46,400 FORCED ME TO THINK MORE 2319 01:46:46,400 --> 01:46:47,835 CAREFULLY ABOUT MY OWN RESEARCH 2320 01:46:47,835 --> 01:46:50,170 AND HOW NEW PROJECTS MAY NEED TO 2321 01:46:50,170 --> 01:46:51,939 SORT OF COME TOGETHER TO SORT OF 2322 01:46:51,939 --> 01:46:54,008 FURTHER THEM TO GO OUT OF MY LAB 2323 01:46:54,008 --> 01:46:55,809 AND BE USEFUL SOMEWHERE ELSE. 2324 01:46:55,809 --> 01:46:56,677 >> THANK YOU. 2325 01:46:56,677 --> 01:47:00,314 YOU KNOW, IT IS VERY MUCH A 2326 01:47:00,314 --> 01:47:04,485 BENEFICIAL SYMBIOTIC 2327 01:47:04,485 --> 01:47:07,755 RELATIONSHIP THAT WE PROVIDE A 2328 01:47:07,755 --> 01:47:10,758 LOT OF LEADER KNOWLEDGE AND WE 2329 01:47:10,758 --> 01:47:13,327 LEVERAGE COMPANY'S KNOWLEDGE IN 2330 01:47:13,327 --> 01:47:16,230 HOW TO GET TECHNOLOGIES 2331 01:47:16,230 --> 01:47:17,831 PROGRESSED TO PATIENTS THAT NEED 2332 01:47:17,831 --> 01:47:18,699 THEM. 2333 01:47:18,699 --> 01:47:19,833 THANKS VERY MUCH. 2334 01:47:19,833 --> 01:47:21,769 AGAIN, PLEASE PUT IN QUESTIONS 2335 01:47:21,769 --> 01:47:24,505 AS THEY COME UP. 2336 01:47:24,505 --> 01:47:26,240 WE WILL NOW SWITCH TO 2337 01:47:26,240 --> 01:47:28,642 [INDISCERNIBLE] WHO IS A 2338 01:47:28,642 --> 01:47:31,445 DIRECTOR OF CORPORATE BUSINESS 2339 01:47:31,445 --> 01:47:33,547 DEVELOPMENT TO TALK ABOUT 2340 01:47:33,547 --> 01:47:38,052 DIAGNOSTIC DEVELOPMENT 2341 01:47:38,052 --> 01:47:39,353 >> THANK YOU VERY MUCH, MICHAEL. 2342 01:47:39,353 --> 01:47:40,954 APPRECIATE THE OPPORTUNITY HERE 2343 01:47:40,954 --> 01:47:43,757 TO CHAT AND SPEAK WITH THE 2344 01:47:43,757 --> 01:47:45,492 AUDIENCE HERE AT NIH AND BOTH 2345 01:47:45,492 --> 01:47:46,360 PRESENT A LITTLE ON THE 2346 01:47:46,360 --> 01:47:46,927 CORPORATE SIDE. 2347 01:47:46,927 --> 01:47:49,997 SO A LITTLE BIT ABOUT MYSELF. 2348 01:47:49,997 --> 01:47:52,266 I HAVE A DOCTORATE IN 2349 01:47:52,266 --> 01:47:53,267 BIOCHEMISTRY AND MOLECULAR 2350 01:47:53,267 --> 01:47:54,468 BIOLOGY THAT GOES BACK QUITE A 2351 01:47:54,468 --> 01:47:55,135 FEW YEARS. 2352 01:47:55,135 --> 01:47:56,236 HAD THE OPPORTUNITY TO WORK AT 2353 01:47:56,236 --> 01:47:59,039 THE CUTTING EDGE OF PCR REALTIME 2354 01:47:59,039 --> 01:48:01,909 PCR AND WATCH FOR EVOLUTION IN 2355 01:48:01,909 --> 01:48:03,410 DNA SEQUENCING DURING THE COURSE 2356 01:48:03,410 --> 01:48:04,078 OF MY TIMES. 2357 01:48:04,078 --> 01:48:06,480 I DO KIND OF IDENTIFY AS AN 2358 01:48:06,480 --> 01:48:09,650 ESCAPED LAB RAT, AND HAVE LEFT 2359 01:48:09,650 --> 01:48:10,951 THE -- AFTER 20 YEARS OF 2360 01:48:10,951 --> 01:48:12,586 ACADEMIC RESEARCH MOVED INTO 2361 01:48:12,586 --> 01:48:13,821 PRODUCT DEVELOPMENT IN THE 2362 01:48:13,821 --> 01:48:15,989 PRIVATE SECTOR AROUND 2004, SO 2363 01:48:15,989 --> 01:48:17,191 ABOUT 20 YEARS AGO. 2364 01:48:17,191 --> 01:48:18,826 AND AFTER A STINT IN THE LAB 2365 01:48:18,826 --> 01:48:21,595 THERE, MOVED INTO TECHNOLOGY 2366 01:48:21,595 --> 01:48:22,996 DEVELOPMENT, WHICH INCLUDED 2367 01:48:22,996 --> 01:48:24,531 TECHNOLOGY SCOUTING AND 2368 01:48:24,531 --> 01:48:25,966 EVALUATIONS, AND ALSO BEEN 2369 01:48:25,966 --> 01:48:28,602 MANAGING LICENSING AND PATENT 2370 01:48:28,602 --> 01:48:30,204 FILINGS FOR INNOVATION PROGRAMS. 2371 01:48:30,204 --> 01:48:34,942 SO ULTIMATELY THE COMPANY I WAS 2372 01:48:34,942 --> 01:48:39,079 WITH WAS ACQUIRED BY QIAGEN, I'M 2373 01:48:39,079 --> 01:48:40,714 NOW CURRENTLY DIRECTOR OF GLOBAL 2374 01:48:40,714 --> 01:48:43,350 LICENSING WITHIN THE IP AND 2375 01:48:43,350 --> 01:48:44,485 LICENSING TEAM IN CORPORATE 2376 01:48:44,485 --> 01:48:46,387 BUSINESS DEVELOPMENT. 2377 01:48:46,387 --> 01:48:47,921 WHILE THE COMPANY IS GERMAN, I'M 2378 01:48:47,921 --> 01:48:50,457 BASED HERE IN MARYLAND, WHICH IS 2379 01:48:50,457 --> 01:48:51,425 WHERE AMERICA'S HEADQUARTERS ARE 2380 01:48:51,425 --> 01:48:53,227 LOCATED SO WE'RE RIGHT IN THE 2381 01:48:53,227 --> 01:48:54,628 MIDST OF THE AREA FOR 2382 01:48:54,628 --> 01:48:55,696 INTERACTING WITH A LOT OF THE 2383 01:48:55,696 --> 01:48:57,364 NIH AND OTHER FINE INSTITUTIONS 2384 01:48:57,364 --> 01:48:59,433 THAT ARE HERE IN THE 2385 01:48:59,433 --> 01:48:59,967 WASHINGTON, D.C. AREA. 2386 01:48:59,967 --> 01:49:02,803 BUT WE ARE TRULY A GLOBAL 2387 01:49:02,803 --> 01:49:05,973 COMPANY IN APPROACH. 2388 01:49:05,973 --> 01:49:11,545 IN WAY OF THE SLIDE THAT I HAVE 2389 01:49:11,545 --> 01:49:15,182 HERE, MANY RECOGNIZE THE BRA 2390 01:49:15,182 --> 01:49:16,183 BRANDING, SO THIS IS SOMETHING 2391 01:49:16,183 --> 01:49:17,251 WE'LL COME BACK TO THE A OTHER 2392 01:49:17,251 --> 01:49:17,651 TIMES. 2393 01:49:17,651 --> 01:49:19,186 WE'VE BEEN AROUND SINCE ABOUT 2394 01:49:19,186 --> 01:49:20,921 1984. 2395 01:49:20,921 --> 01:49:23,724 THIS IS -- I NEED TO PUT OUR 2396 01:49:23,724 --> 01:49:25,359 DISCLAIMERS IN ABOUT FORWARD 2397 01:49:25,359 --> 01:49:26,560 LOOKING AND HISTORICAL 2398 01:49:26,560 --> 01:49:27,194 STATEMENTS ON HERE. 2399 01:49:27,194 --> 01:49:29,263 BUT REALLY WHERE WE'RE COMING 2400 01:49:29,263 --> 01:49:31,465 THROUGH IS WE ARE A FACILITATOR 2401 01:49:31,465 --> 01:49:32,466 IN MANY WAYS. 2402 01:49:32,466 --> 01:49:34,168 WE ARE A TECHNOLOGY-BASED 2403 01:49:34,168 --> 01:49:36,603 COMPANY THAT FOCUSES PRIMARILY 2404 01:49:36,603 --> 01:49:39,773 AROUND NUCLEIC ACID TESTING AND 2405 01:49:39,773 --> 01:49:41,642 ANALYSIS, AND ALL OF ITS VARIOUS 2406 01:49:41,642 --> 01:49:43,277 SPECTRUMS, WITH THE GOAL OF 2407 01:49:43,277 --> 01:49:44,711 MAKING IMPROVEMENTS IN LIFE 2408 01:49:44,711 --> 01:49:45,245 POSSIBLE. 2409 01:49:45,245 --> 01:49:46,346 REALIZING THAT THIS IS NOT 2410 01:49:46,346 --> 01:49:48,515 SOMETHING WE CAN DO ON OUR OWN, 2411 01:49:48,515 --> 01:49:50,617 BUT RATHER SOMETHING THAT WE DO 2412 01:49:50,617 --> 01:49:52,586 WITH A VARIETY OF DIFFERENT 2413 01:49:52,586 --> 01:49:54,655 PARTNERS ACROSS THE SPECTRUM. 2414 01:49:54,655 --> 01:49:56,023 AND I'LL ELABORATE MORE ON 2415 01:49:56,023 --> 01:49:56,290 THOSE. 2416 01:49:56,290 --> 01:49:58,058 WHEN YOU LOOK AT OUR BUSINESS AS 2417 01:49:58,058 --> 01:50:00,561 A WHOLE AND OUR INTERESTS, WE 2418 01:50:00,561 --> 01:50:03,630 ARE LOOKING AT A PHRASE THAT WE 2419 01:50:03,630 --> 01:50:05,599 CALL SAMPLE TO INCITE. 2420 01:50:05,599 --> 01:50:07,568 AS THE GENETIC AND GENOMICS 2421 01:50:07,568 --> 01:50:11,271 REVOLUTION HAS EVOLVED, THE 2422 01:50:11,271 --> 01:50:13,574 TECHNICAL DETAILS AND 2423 01:50:13,574 --> 01:50:14,575 COMPLEXITIES OF THE TESTS THAT 2424 01:50:14,575 --> 01:50:17,845 ARE BEING RUN ON PEOPLE'S 2425 01:50:17,845 --> 01:50:20,347 SAMPLES FOR DNA AND RNA AND 2426 01:50:20,347 --> 01:50:21,348 EPIGENETICS HAVE BECOME 2427 01:50:21,348 --> 01:50:22,883 INCREASINGLY COMPLEX AND HIGHLY 2428 01:50:22,883 --> 01:50:24,184 SPECIALIZED TO THE EXTENT THAT 2429 01:50:24,184 --> 01:50:26,053 MANY OF THE PRACTITIONERS OR 2430 01:50:26,053 --> 01:50:27,921 PEOPLE ASKING QUESTIONS AT THE 2431 01:50:27,921 --> 01:50:30,557 FRONT END ARE NOT SKILLED IN THE 2432 01:50:30,557 --> 01:50:32,493 DETAILS OF THE WAYS OF GETTING 2433 01:50:32,493 --> 01:50:34,795 THE ANSWER, BUT NEED THOSE 2434 01:50:34,795 --> 01:50:37,531 ANSWERS IN ORDER TO PROVIDE THE 2435 01:50:37,531 --> 01:50:42,102 GUIDANCE TO PATIENTS AND/OR 2436 01:50:42,102 --> 01:50:43,737 OTHER SORTS OF PEOPLE ASKING 2437 01:50:43,737 --> 01:50:47,708 QUESTIONS OF NUCLEIC ACIDS. 2438 01:50:47,708 --> 01:50:52,646 SO THIS HAS BEEN A CORNERSTONE 2439 01:50:52,646 --> 01:50:53,180 FOR US. 2440 01:50:53,180 --> 01:50:54,848 WE ARE A SOLID MID CAP COMPANY, 2441 01:50:54,848 --> 01:50:56,350 WE'RE PUBLICLY HELD ON THE 2442 01:50:56,350 --> 01:50:57,651 NEW YORK STOCK EXCHANGE. 2443 01:50:57,651 --> 01:51:00,721 THESE NUMBERS ARE HERE FROM OUR 2444 01:51:00,721 --> 01:51:03,123 2022 PERFORMANCE, AGGREGATING 2445 01:51:03,123 --> 01:51:03,790 OUR 2023 PERFORMANCE STILL. 2446 01:51:03,790 --> 01:51:05,759 THIS IS ABOUT $2 BILLION WHEN WE 2447 01:51:05,759 --> 01:51:07,828 ARE TRULY A GLOBAL COMPANY 2448 01:51:07,828 --> 01:51:11,265 COVERING THE AMERICAS, EUROPEAN, 2449 01:51:11,265 --> 01:51:13,834 MIDDLE EAST AFRICA AS WELL AS 2450 01:51:13,834 --> 01:51:15,602 THE ASIAN PACIFIC MARKETS. 2451 01:51:15,602 --> 01:51:16,803 FUNDAMENTALLY, WE ARE INTERESTED 2452 01:51:16,803 --> 01:51:19,640 IN SELLING CONSUMABLES AND KITS. 2453 01:51:19,640 --> 01:51:24,211 THESE ARE THE NUCLEIC ISOLATION 2454 01:51:24,211 --> 01:51:26,313 KITS, THEY ARE PCR ASSAYS. 2455 01:51:26,313 --> 01:51:27,080 INSTRUMENTS ARE A MEANS OF 2456 01:51:27,080 --> 01:51:29,149 MAKING IT EASIER FOR CUSTOMERS 2457 01:51:29,149 --> 01:51:32,219 TO USE OUR KITS, AND EASIER AND 2458 01:51:32,219 --> 01:51:34,321 LESS TIME-INTENSIVE TO ARRIVING 2459 01:51:34,321 --> 01:51:36,590 AT THE RESULTS THAT THEY NEED 2460 01:51:36,590 --> 01:51:40,360 FROM THE SAMPLES THAT THEY HAVE. 2461 01:51:40,360 --> 01:51:42,062 WE COVER A RATHER BROAD SPECTRUM 2462 01:51:42,062 --> 01:51:44,698 WHEN I SAY THE CUSTOMERS, WHICH 2463 01:51:44,698 --> 01:51:47,234 INCLUDES ABOUT A 50/50 SPLIT 2464 01:51:47,234 --> 01:51:48,835 BETWEEN CLINICAL AND MOLECULAR 2465 01:51:48,835 --> 01:51:50,704 DIAGNOSTIC CUSTOMER BASE, AND 2466 01:51:50,704 --> 01:51:52,673 THE LIFE SCIENCES OR BASIC 2467 01:51:52,673 --> 01:51:53,473 RESEARCH BASE. 2468 01:51:53,473 --> 01:51:58,312 A COMPANY IS MORE THAN 6,000 -- 2469 01:51:58,312 --> 01:51:59,780 AT THIS TIME WITH OVER HALF A 2470 01:51:59,780 --> 01:52:01,081 MILLION CUSTOMERS WORLDWIDE THAT 2471 01:52:01,081 --> 01:52:02,516 RELY ON OUR PRODUCTS. 2472 01:52:02,516 --> 01:52:03,750 AND WHEN YOU LOOK AT THE 2473 01:52:03,750 --> 01:52:04,952 PRODUCTS AND WHO IS USING IT, 2474 01:52:04,952 --> 01:52:09,957 ONE OF THE THINGS THAT WE HAVE A 2475 01:52:09,957 --> 01:52:11,158 REALLY NEAT TIME WHEN IT COMES 2476 01:52:11,158 --> 01:52:13,660 TIME FOR NOBEL PRIZES IS SEEING 2477 01:52:13,660 --> 01:52:14,661 HOW MANY OF THE WINNERS THAT 2478 01:52:14,661 --> 01:52:15,963 YEAR IN CHEMISTRY AND MEDICINE 2479 01:52:15,963 --> 01:52:18,165 END UP HAVING THEIR LAB PHOTOS 2480 01:52:18,165 --> 01:52:20,434 WITH A QIAGEN BOX IN THE 2481 01:52:20,434 --> 01:52:20,734 BACKGROUND. 2482 01:52:20,734 --> 01:52:22,402 WE'RE PRETTY CONFIDENT THIS IS 2483 01:52:22,402 --> 01:52:23,737 NOT AN INTENTIONAL THING ON 2484 01:52:23,737 --> 01:52:26,273 THEIR PART, WE CERTAINLY AREN'T 2485 01:52:26,273 --> 01:52:27,240 LOBBYING FOR THEM TO DO THAT, 2486 01:52:27,240 --> 01:52:29,209 BUT I THINK IT REALLY KIND OF 2487 01:52:29,209 --> 01:52:30,410 HIGHLIGHTS JUST HOW UBIQUITOUS 2488 01:52:30,410 --> 01:52:32,179 WE ARE IN THE SPACE OF DNA AND 2489 01:52:32,179 --> 01:52:34,247 NUCLEIC AND RNA ANALYSIS. 2490 01:52:34,247 --> 01:52:36,249 THAT'S THE STARTING POINT FOR 2491 01:52:36,249 --> 01:52:40,921 EXTRACTING. 2492 01:52:40,921 --> 01:52:42,222 WHEN YOU LOOK AT OUR BUSINESS 2493 01:52:42,222 --> 01:52:43,991 FOCUSES, THIS SLIDE REALLY, I 2494 01:52:43,991 --> 01:52:46,393 THINK, ENCAPSULATES THE FOUR 2495 01:52:46,393 --> 01:52:47,561 MAJOR FOCUS AREAS FOR OUR 2496 01:52:47,561 --> 01:52:48,996 COMPANY. 2497 01:52:48,996 --> 01:52:52,165 THAT IS REALLY THE KNOWLEDGE 2498 01:52:52,165 --> 01:52:54,601 ABOUT DNA/RNA PROTEINS, WHILE WE 2499 01:52:54,601 --> 01:52:57,404 FOCUS PRIMARILY ON DNA/RNA, 2500 01:52:57,404 --> 01:52:58,939 PRIMARILY THESE ARE THE 2501 01:52:58,939 --> 01:53:00,273 PRECURSORS GOING INTO PROTEINS 2502 01:53:00,273 --> 01:53:01,341 DOING THE WORK FOR THE COMPANY, 2503 01:53:01,341 --> 01:53:03,644 AND WE RECOGNIZE THAT THERE IS 2504 01:53:03,644 --> 01:53:06,513 ALWAYS GOING TO BE A NEED FOR 2505 01:53:06,513 --> 01:53:07,814 THIS TO BE ONE PIECE OF THE 2506 01:53:07,814 --> 01:53:10,217 OVERALL PUZZLE THAT IS ANYTHING 2507 01:53:10,217 --> 01:53:12,419 IN BIOLOGY. 2508 01:53:12,419 --> 01:53:13,587 WHEN YOU LOOK AT SPECIFIC AREAS 2509 01:53:13,587 --> 01:53:15,255 IN WHICH WE'VE TARGETED, 2510 01:53:15,255 --> 01:53:16,590 TUBERCULOSIS IS ONE AREA WHERE 2511 01:53:16,590 --> 01:53:19,092 WE HAVE A MAJOR IMPACT ON THE 2512 01:53:19,092 --> 01:53:23,330 MARKET THROUGH OUR TB TEST 2513 01:53:23,330 --> 01:53:24,898 FRANCHISE, WHICH IS ACTUALLY 2514 01:53:24,898 --> 01:53:26,833 BASED HERE IN MARYLAND FOR 2515 01:53:26,833 --> 01:53:27,934 MANUFACTURING AND PRODUCT 2516 01:53:27,934 --> 01:53:31,605 DEVELOPMENT. 2517 01:53:31,605 --> 01:53:32,973 THIS IS A GLOBAL ISSUE, BUT IT 2518 01:53:32,973 --> 01:53:36,143 AFFECTS THE FIRST WORLD AS MUCH 2519 01:53:36,143 --> 01:53:37,678 AS -- AS WELL AS 2520 01:53:37,678 --> 01:53:38,478 RESOURCE-CHALLENGED AREAS AND 2521 01:53:38,478 --> 01:53:41,048 WE'VE APPROACHED THIS FROM 2522 01:53:41,048 --> 01:53:41,848 MULTIPLE WAYS. 2523 01:53:41,848 --> 01:53:42,916 CANCER REMAINS A LEADING 2524 01:53:42,916 --> 01:53:43,950 INTEREST FOR US. 2525 01:53:43,950 --> 01:53:46,453 WE HAVE DIAGNOSTICS FRANCHISE 2526 01:53:46,453 --> 01:53:49,256 THAT IS FOCUSED ON VARIOUS TYPES 2527 01:53:49,256 --> 01:53:52,459 OF CANCER DIAGNOSTICS. 2528 01:53:52,459 --> 01:53:53,894 AND ALSO THIS IS AN AREA WHERE 2529 01:53:53,894 --> 01:53:54,961 WITH THE AMOUNT OF RESEARCH THAT 2530 01:53:54,961 --> 01:53:56,063 GOES ON IN TERMS OF REALLY 2531 01:53:56,063 --> 01:53:57,731 TRYING TO UNDERSTAND THE 2532 01:53:57,731 --> 01:53:59,466 COMPLEXITIES AND THE TIES TO 2533 01:53:59,466 --> 01:54:01,168 GENETIC CHANGES THAT ARE 2534 01:54:01,168 --> 01:54:02,335 HAPPENING THROUGH SOMATIC 2535 01:54:02,335 --> 01:54:05,906 MUTATIONS AND RECOMBINATIONS IN 2536 01:54:05,906 --> 01:54:07,107 CANCER, WHERE IT ALSO OVERLAPSE 2537 01:54:07,107 --> 01:54:09,710 WITH OUR RESEARCH PRODUCTS AND 2538 01:54:09,710 --> 01:54:12,546 TOOLS. 2539 01:54:12,546 --> 01:54:13,880 FINALLY AS A FOCUS AREA, 2540 01:54:13,880 --> 01:54:15,082 INFECTIOUS DISEASE, WHICH HAS 2541 01:54:15,082 --> 01:54:16,316 REALLY COME ABOUT, A LOT OF 2542 01:54:16,316 --> 01:54:17,718 PEOPLE HAVE REALLY KIND OF 2543 01:54:17,718 --> 01:54:19,352 GAINED A DIFFERENT APPRECIATION 2544 01:54:19,352 --> 01:54:26,026 IN LIGHT OF THE PAN DEME PANDEMS 2545 01:54:26,026 --> 01:54:28,228 AFTERMATH AS TO HOW MUCH IMPACT 2546 01:54:28,228 --> 01:54:31,064 A VIRAL PATHOGEN CAN HAVE ON NOT 2547 01:54:31,064 --> 01:54:32,466 JUST INDIVIDUALS BUT GLOBAL 2548 01:54:32,466 --> 01:54:36,970 ECONOMIES ALL AT THE SAME TIME. 2549 01:54:36,970 --> 01:54:38,605 SO THIS SLIDE KIND OF GOES A 2550 01:54:38,605 --> 01:54:39,806 LITTLE MORE DEEPER INTO HOW WE 2551 01:54:39,806 --> 01:54:43,310 VIEW A SAMPLE INSIGHT AND THE 2552 01:54:43,310 --> 01:54:44,177 COMPLEXITIES ALONG THIS. 2553 01:54:44,177 --> 01:54:45,278 YOU'LL SEE SORT OF THREE COLUMNS 2554 01:54:45,278 --> 01:54:46,813 HERE STARTING WITH THE VARIOUS 2555 01:54:46,813 --> 01:54:50,283 TYPES OF SAMPLES THAT WE CAN 2556 01:54:50,283 --> 01:54:51,718 PROCESS, AND EACH OF THOSE 2557 01:54:51,718 --> 01:54:52,919 SAMPLES REQUIRES A DIFFERENT SET 2558 01:54:52,919 --> 01:54:56,757 OF CIRCUMSTANCES, REAGENTS, FOR 2559 01:54:56,757 --> 01:54:58,925 THE EFFECTIVE AND EFFICIENT 2560 01:54:58,925 --> 01:55:00,360 EXTRACTION OF THE TARGETED 2561 01:55:00,360 --> 01:55:02,329 MATERIAL. 2562 01:55:02,329 --> 01:55:09,002 TARGETED NANOLYTES, CIRCULATING 2563 01:55:09,002 --> 01:55:10,871 FREE DNA, SMALL INDIVIDUAL AND 2564 01:55:10,871 --> 01:55:11,605 ENVIRONMENTAL DNAs THAT COULD 2565 01:55:11,605 --> 01:55:15,008 BE RNAs AND SO DEPENDING UPON 2566 01:55:15,008 --> 01:55:18,712 THE NATURE OF THE QUESTION, MUCH 2567 01:55:18,712 --> 01:55:23,083 OF THIS WORKFLOW IS DICTATED BY 2568 01:55:23,083 --> 01:55:26,052 THE SAMPLE, THE TYPE OF 2569 01:55:26,052 --> 01:55:27,354 QUESTION, AND WHAT IS THE 2570 01:55:27,354 --> 01:55:27,954 ANALYTICAL APPLICATION THAT'S 2571 01:55:27,954 --> 01:55:30,423 BEING USED ON THIS. 2572 01:55:30,423 --> 01:55:33,927 YOU CAN VIEW IT AS SORT OF A 2573 01:55:33,927 --> 01:55:34,961 COMBINATIONAL MATRIX ALONG HERE. 2574 01:55:34,961 --> 01:55:36,329 MUCH OF WHAT WE DO WHEN WORKING 2575 01:55:36,329 --> 01:55:37,597 WITH CUSTOMERS IS HELP THEM 2576 01:55:37,597 --> 01:55:39,633 IDENTIFY WITH THEIR PARTICULAR 2577 01:55:39,633 --> 01:55:43,436 STARTING SAMPLE, THEIR 2578 01:55:43,436 --> 01:55:44,104 PARTICULAR QUESTION AT THE END, 2579 01:55:44,104 --> 01:55:45,238 WHAT ARE THE MOST EFFECTIVE WAYS 2580 01:55:45,238 --> 01:55:47,941 TO GET THE ANSWER OUT OF THAT 2581 01:55:47,941 --> 01:55:50,577 SAMPLE AND FOR THEM TO USE THAT 2582 01:55:50,577 --> 01:55:53,113 SAMPLE TO EITHER ADVANCE THEIR 2583 01:55:53,113 --> 01:55:59,953 RESEARCH OR HELP TREAT PATIENTS. 2584 01:55:59,953 --> 01:56:01,655 ANOTHER WAY OF LOOKING AT OUR 2585 01:56:01,655 --> 01:56:03,123 FOCUS AREA KIND OF BREAKS DOWN 2586 01:56:03,123 --> 01:56:04,524 INTO THE ACTUAL BUSINESS UNITS, 2587 01:56:04,524 --> 01:56:06,426 AND WE'VE HAD SOME CHANGES 2588 01:56:06,426 --> 01:56:07,494 OURSELF IN TERMS OF RESPONDING 2589 01:56:07,494 --> 01:56:09,496 TO THE PANDEMIC AND RESPONDING 2590 01:56:09,496 --> 01:56:10,597 TO GLOBAL CHANGES, RESPONDING 2591 01:56:10,597 --> 01:56:12,432 SOME OF OUR OWN EFFORTS AS WELL 2592 01:56:12,432 --> 01:56:15,502 GOING BACK INTO 2019. 2593 01:56:15,502 --> 01:56:17,103 WHAT YOU'LL SEE ACROSS THE TOP 2594 01:56:17,103 --> 01:56:19,105 ROW HERE IS REALLY WHAT WE CALL 2595 01:56:19,105 --> 01:56:21,308 OUR FIVE PILLARS OF GROWTH. 2596 01:56:21,308 --> 01:56:23,376 FOCUSING ON THE FIRST TWO, WHERE 2597 01:56:23,376 --> 01:56:24,911 THESE ARE AREAS THAT WERE WELL 2598 01:56:24,911 --> 01:56:26,346 ESTABLISHED AND HAVE BEEN AROUND 2599 01:56:26,346 --> 01:56:27,781 IN QIAGEN IN THE FIRST CASE 2600 01:56:27,781 --> 01:56:33,053 SINCE OUR FOUNDING IN 1984, ON 2601 01:56:33,053 --> 01:56:34,387 SAMPLE ISOLATION TECHNOLOGY TO 2602 01:56:34,387 --> 01:56:36,122 ONE OF OUR MAJOR INVESTMENTS 2603 01:56:36,122 --> 01:56:38,592 INTO DIAGNOSTICS OR QUANTIFERON 2604 01:56:38,592 --> 01:56:40,393 AROUND 2010. 2605 01:56:40,393 --> 01:56:43,730 AND THIS PARTICULAR ONE, THE 2606 01:56:43,730 --> 01:56:45,498 QUANTIFERON TUBERCULOSIS TEST IS 2607 01:56:45,498 --> 01:56:46,600 AN IMMUNE RESPONSE TEST AND IT 2608 01:56:46,600 --> 01:56:49,603 IS NOT A NUCLEIC ACID TEST, BUT 2609 01:56:49,603 --> 01:56:51,838 RATHER A TEST ON A PLATFORM 2610 01:56:51,838 --> 01:56:53,807 CALLED INTERFERON GAMMA 2611 01:56:53,807 --> 01:56:54,975 RELEASING ASSAY, WHICH INSTEAD 2612 01:56:54,975 --> 01:56:58,378 OF ACTUALLY TRYING TO IDENTIFY 2613 01:56:58,378 --> 01:56:59,813 AND ACTUALLY TAG THE PATHOGEN 2614 01:56:59,813 --> 01:57:01,348 ITSELF AND PULL IT OUT, IS 2615 01:57:01,348 --> 01:57:07,654 ACTUALLY A WAY OF LOOKING AT THE 2616 01:57:07,654 --> 01:57:08,355 PATIENT'S IMMUNE RESPONSE AND 2617 01:57:08,355 --> 01:57:10,023 WHETHER THEY HAVE AN IMMUNE 2618 01:57:10,023 --> 01:57:12,058 MEMORY FOR THE PA PATHOGEN IN 2619 01:57:12,058 --> 01:57:14,995 QUESTION FOR THIS. 2620 01:57:14,995 --> 01:57:16,363 THREE OTHER AREAS WE'VE BEEN 2621 01:57:16,363 --> 01:57:17,197 PRETTY EXCITED ABOUT BRINGING 2622 01:57:17,197 --> 01:57:19,165 INTO PLAY ARE ACTUALLY THREE OF 2623 01:57:19,165 --> 01:57:21,134 OUR INSTRUMENT SYSTEMS THAT WERE 2624 01:57:21,134 --> 01:57:23,203 LAUNCHED EITHER SHORTLY BEFORE, 2625 01:57:23,203 --> 01:57:24,404 WITHIN ABOUT A YEAR BEFORE THE 2626 01:57:24,404 --> 01:57:27,474 PANDEMIC STARTED IN THE CASE OF 2627 01:57:27,474 --> 01:57:30,744 THE QIASTAT VX OR THE FIRST YEAR 2628 01:57:30,744 --> 01:57:32,946 OF THE PANDEMIC IN THE CASE OF 2629 01:57:32,946 --> 01:57:33,947 THE HIGH-THROUGHPUT TESTING 2630 01:57:33,947 --> 01:57:36,650 SYSTEM FOR THE CLINICAL LABS AND 2631 01:57:36,650 --> 01:57:38,618 THE DIGITAL PCR PLATFORM FOR THE 2632 01:57:38,618 --> 01:57:40,921 RESEARCH AREA TO HELP PROVIDE A 2633 01:57:40,921 --> 01:57:42,055 DIFFERENT WAY AND ENHANCEMENTS 2634 01:57:42,055 --> 01:57:45,091 IN TERMS OF SENSITIVITY AND 2635 01:57:45,091 --> 01:57:46,660 LOWER LIMITS OF DETECTION OF PCR 2636 01:57:46,660 --> 01:57:52,532 IN THE RESEARCH SETTINGS. 2637 01:57:52,532 --> 01:57:53,700 BELOW THAT YOU'LL SEE WE ALSO 2638 01:57:53,700 --> 01:57:55,802 HAVE OTHER AREAS OF FOCUS. 2639 01:57:55,802 --> 01:57:57,604 WE ARE VERY STRONG AND ACTIVE IN 2640 01:57:57,604 --> 01:57:58,204 THE GENOMICS FIELD. 2641 01:57:58,204 --> 01:57:59,739 THIS IS FROM BOTH THE SAMPLE 2642 01:57:59,739 --> 01:58:01,808 PREP AND LIBRARY PREPARATION, 2643 01:58:01,808 --> 01:58:04,678 ESPECIALLY AROUND TARGETED DNA 2644 01:58:04,678 --> 01:58:04,978 SEQUENCING. 2645 01:58:04,978 --> 01:58:07,514 WE HAVE A WHOLE BUSINESS 2646 01:58:07,514 --> 01:58:08,982 DIVISION IN HUMAN IDENTIFICATION 2647 01:58:08,982 --> 01:58:10,550 AND FORENSICS THAT SPANS THE 2648 01:58:10,550 --> 01:58:12,652 ENTIRE WORKFLOW AS WELL. 2649 01:58:12,652 --> 01:58:14,854 THIS IS NOT A MARKET THAT PEOPLE 2650 01:58:14,854 --> 01:58:16,790 TYPICALLY IN OUR CLINICAL AND 2651 01:58:16,790 --> 01:58:18,091 BASIC RESEARCH SETTINGS HEAR 2652 01:58:18,091 --> 01:58:19,659 ABOUT, BUT THIS IS A VERY 2653 01:58:19,659 --> 01:58:20,627 IMPORTANT MARKET SEGMENT WHEN 2654 01:58:20,627 --> 01:58:24,130 YOU LOOK AT NOT ONLY THE COURT 2655 01:58:24,130 --> 01:58:25,098 CASES THAT ARE UTILIZING 2656 01:58:25,098 --> 01:58:27,100 EVIDENCE THAT IS COMING IN HERE, 2657 01:58:27,100 --> 01:58:30,070 BUT ALSO TO SUPPORT MASS 2658 01:58:30,070 --> 01:58:32,339 CASUALTY INCIDENCES AND BODY 2659 01:58:32,339 --> 01:58:34,407 IDENTIFICATIONS FROM THOSE, WHAT 2660 01:58:34,407 --> 01:58:35,742 WHETHER THEY BE NATURAL 2661 01:58:35,742 --> 01:58:37,277 DISASTERS OR WARTIME DISASTERS 2662 01:58:37,277 --> 01:58:38,812 WHERE THERE ARE HUMAN REMAINS 2663 01:58:38,812 --> 01:58:41,281 THAT NEED TO BE REPATRIATED AND 2664 01:58:41,281 --> 01:58:42,282 IDENTIFIED SO THAT FAMILIES CAN 2665 01:58:42,282 --> 01:58:44,050 HAVE CLOSURES ON THEIR LOVED 2666 01:58:44,050 --> 01:58:48,388 ONES. 2667 01:58:48,388 --> 01:58:49,756 ONCOLOGY IS ALSO TIED INTO SOME 2668 01:58:49,756 --> 01:58:51,157 OF THESE TESTING PLATFORMS, 2669 01:58:51,157 --> 01:58:52,459 ESPECIALLY THE PCR TYPES OF 2670 01:58:52,459 --> 01:58:55,395 SYSTEMS WE HAVE AND THE NEXT 2671 01:58:55,395 --> 01:58:57,063 GENERATION DNA SEQUENCING, AND 2672 01:58:57,063 --> 01:58:58,298 OF COURSE WITH SEQUENCING AND 2673 01:58:58,298 --> 01:59:00,900 SOME OF THE MASSIVELY PARALLEL 2674 01:59:00,900 --> 01:59:04,070 THINGS COMING OUT INITIALLY WITH 2675 01:59:04,070 --> 01:59:05,271 MICROWAVES, THE ABILITY TO 2676 01:59:05,271 --> 01:59:09,542 MANAGE THE EXTREMELY LARGE LOAD 2677 01:59:09,542 --> 01:59:11,378 OF NUCLEIC ACID SEQUENCE DATA 2678 01:59:11,378 --> 01:59:14,114 THAT IS COMING OUT WITH THE 2679 01:59:14,114 --> 01:59:16,082 GENOMICS REVOLUTION IS A MAJOR 2680 01:59:16,082 --> 01:59:18,284 COMPONENT AND ESSENTIAL TO 2681 01:59:18,284 --> 01:59:19,185 UNDERSTANDING WHAT IS HAPPENING 2682 01:59:19,185 --> 01:59:21,121 FROM THE SAMPLE AND THE AMOUNT 2683 01:59:21,121 --> 01:59:24,057 OF DATA THAT'S COMING OUT. 2684 01:59:24,057 --> 01:59:27,994 QIAGEN IS THE WORLD'S LEADER IN 2685 01:59:27,994 --> 01:59:30,397 BIOINFORMATICS ANALYSIS AND 2686 01:59:30,397 --> 01:59:32,932 INTERPRETATION COMING OFF OF 2687 01:59:32,932 --> 01:59:34,567 NUCLEIC ACID SEQUENCING AND ALSO 2688 01:59:34,567 --> 01:59:36,970 OTHER TYPES OF NUCLEIC ACID 2689 01:59:36,970 --> 01:59:37,537 TESTING. 2690 01:59:37,537 --> 01:59:38,938 OUR BUSINESS DIVISION HERE IS 2691 01:59:38,938 --> 01:59:40,874 SPLIT OUT GLOBALLY BETWEEN THE 2692 01:59:40,874 --> 01:59:43,410 UNITED STATES AND EUROPE, BUT WE 2693 01:59:43,410 --> 01:59:44,778 HAVE -- AND IT ALSO COVERS 2694 01:59:44,778 --> 01:59:46,579 RESEARCH APPLICATIONS AS WELL AS 2695 01:59:46,579 --> 01:59:50,650 CLINICAL INSIGHTS APPLICATIONS. 2696 01:59:50,650 --> 01:59:52,786 THE FINAL POINT I LIKE TO ALSO 2697 01:59:52,786 --> 01:59:54,254 BRING OUT TO PEOPLE THAT IS 2698 01:59:54,254 --> 01:59:55,455 REALLY AGAIN NOT INSIDE THE 2699 01:59:55,455 --> 01:59:58,625 COMMON KNOWLEDGE OF QIAGEN BUT 2700 01:59:58,625 --> 02:00:00,360 AS AN OEM PROVIDER. 2701 02:00:00,360 --> 02:00:01,161 BECAUSE WE DO RECOGNIZE THAT HE 2702 02:00:01,161 --> 02:00:03,563 WITH CANNOT MEET AND ADDRESS 2703 02:00:03,563 --> 02:00:06,800 EVERY INVESTIGATOR'S NEED BUT WE 2704 02:00:06,800 --> 02:00:08,368 HAVE TECHNICAL REAGENT AND 2705 02:00:08,368 --> 02:00:10,003 INSTRUMENT CAPABILITIES THAT CAN 2706 02:00:10,003 --> 02:00:11,871 BE UTILIZED BY OTHER COMPANIES. 2707 02:00:11,871 --> 02:00:15,275 WE HAVE A VERY STRONG OEM 2708 02:00:15,275 --> 02:00:18,745 BUSINESS THAT SPANS A RANGE FROM 2709 02:00:18,745 --> 02:00:19,846 ENZYMES, SIMPLY ISOLATED 2710 02:00:19,846 --> 02:00:22,582 ENZYMES, WHICH SUPPORT MANY OF 2711 02:00:22,582 --> 02:00:24,384 THE NGS SEQUENCING KITS THAT ARE 2712 02:00:24,384 --> 02:00:25,652 ON THE MARKET TO WHOLE KITS THAT 2713 02:00:25,652 --> 02:00:28,388 ARE LABELED FOR OUR PARTNERS, TO 2714 02:00:28,388 --> 02:00:30,023 INSTRUMENT SYSTEMS THAT OUR 2715 02:00:30,023 --> 02:00:33,526 PARTNERS HAVE THAT UTILIZE -- 2716 02:00:33,526 --> 02:00:36,362 THAT CARRY 5 10K CLEARS WITH 2717 02:00:36,362 --> 02:00:39,966 THEIR ASSAYS FOR FDA APPROVAL 2718 02:00:39,966 --> 02:00:41,401 BUT PLATFORMS YOU WILL NOT 2719 02:00:41,401 --> 02:00:43,103 REGULARLY SEE IN THE QIAGEN 2720 02:00:43,103 --> 02:00:43,470 CATALOG. 2721 02:00:43,470 --> 02:00:44,437 SO THIS BUSINESS TO BUSINESS 2722 02:00:44,437 --> 02:00:45,872 OFFERING HAS ALSO BEEN A VERY 2723 02:00:45,872 --> 02:00:46,573 IMPORTANT PART IN THE WAY THAT 2724 02:00:46,573 --> 02:00:48,508 WE WORK. 2725 02:00:48,508 --> 02:00:49,909 I KIND OF LIKE TO WRAP THAT 2726 02:00:49,909 --> 02:00:50,944 AROUND THE FACT THAT IT 2727 02:00:50,944 --> 02:00:52,112 HOPEFULLY IS STARTING TO COME 2728 02:00:52,112 --> 02:00:54,647 ACROSS THAT QIAGEN IS A VERY 2729 02:00:54,647 --> 02:00:55,748 COLLEGIAL COMPANY TO WORK WITH. 2730 02:00:55,748 --> 02:00:56,816 WE'RE VERY FLEXIBLE WHEN IT 2731 02:00:56,816 --> 02:00:59,886 COMES TO PARTNERING AND REALLY 2732 02:00:59,886 --> 02:01:01,521 ARE LOOKING FOR WAYS THAT WE CAN 2733 02:01:01,521 --> 02:01:04,491 OPTIMIZE THE VALUE FOR BOTH THE 2734 02:01:04,491 --> 02:01:05,892 COMPANY AS WELL AS THE PARTNERS 2735 02:01:05,892 --> 02:01:09,028 THAT WE'RE WORKING WITH. 2736 02:01:09,028 --> 02:01:11,798 I'D LIKE TO SORT OF WRAPPING UP 2737 02:01:11,798 --> 02:01:14,767 ON MY SIDE OF TWO OTHER POINTS 2738 02:01:14,767 --> 02:01:15,401 OF QIAGEN AS A COMPANY, I 2739 02:01:15,401 --> 02:01:16,603 MENTIONED IT EARLIER BUT WE 2740 02:01:16,603 --> 02:01:17,804 TRULY ARE A GLOBAL COMPANY. 2741 02:01:17,804 --> 02:01:21,975 WHEN YOU LOOK AT THE DIAGNOSTICS 2742 02:01:21,975 --> 02:01:23,643 MARKET ESPECIALLY, THIS MARKET 2743 02:01:23,643 --> 02:01:26,779 GLOBALLY IS VERY MUCH SEGMENTED 2744 02:01:26,779 --> 02:01:27,780 INTO WHICH MARKET REGION YOU'RE 2745 02:01:27,780 --> 02:01:28,548 GOING TO. 2746 02:01:28,548 --> 02:01:30,517 BOTH FROM THE SIZE AND 2747 02:01:30,517 --> 02:01:31,551 ECONOMIC -- IN TERMS OF ECONOMIC 2748 02:01:31,551 --> 02:01:34,554 OPPORTUNITY FOR THAT MARKET, AS 2749 02:01:34,554 --> 02:01:35,855 WELL AS REGULATORY OVERSIGHT FOR 2750 02:01:35,855 --> 02:01:37,357 GETTING APPROVALS AND USING IN 2751 02:01:37,357 --> 02:01:39,259 THOSE MARKETS. 2752 02:01:39,259 --> 02:01:42,428 I'VE MENTIONED THE QUANTIFERON 2753 02:01:42,428 --> 02:01:46,366 TB ASSAY WHICH IS FULLY 2754 02:01:46,366 --> 02:01:47,567 U.S.-APPROVED IBB ASSAY 2755 02:01:47,567 --> 02:01:48,568 AVAILABLE IN THE UNITED STATES 2756 02:01:48,568 --> 02:01:51,504 AND OTHER COUNTRIES AROUND 2757 02:01:51,504 --> 02:01:52,372 EUROPE, BUT IT IS ONE THAT 2758 02:01:52,372 --> 02:01:53,806 REQUIRES A LEVEL OF COMPLEXITY 2759 02:01:53,806 --> 02:01:57,310 THAT IS NOT READILY AVAILABLE IN 2760 02:01:57,310 --> 02:02:00,213 EMERGING COMPANIES IN LOWER 2761 02:02:00,213 --> 02:02:01,147 RESOURCE PARTS OF THE WORLD. 2762 02:02:01,147 --> 02:02:02,348 WE HAVE CREATED A VERSION OF 2763 02:02:02,348 --> 02:02:04,317 THIS THAT IS BASED ON MORE OF A 2764 02:02:04,317 --> 02:02:10,323 LATERAL FLOW READOUT CALLED THE 2765 02:02:10,323 --> 02:02:12,525 QIA REACH PROGRAM MUCH MORE 2766 02:02:12,525 --> 02:02:14,227 STANDALONE, DOES NOT REQUIRE THE 2767 02:02:14,227 --> 02:02:15,261 HIGH COMPLEXITY LABORATORY 2768 02:02:15,261 --> 02:02:17,197 SETTINGS TO HELP RUN THAT TO 2769 02:02:17,197 --> 02:02:18,865 BRING TB TESTING INTO MORE OF A 2770 02:02:18,865 --> 02:02:21,601 LARGER POPULATION SCREENING 2771 02:02:21,601 --> 02:02:22,468 WORLD. 2772 02:02:22,468 --> 02:02:26,639 SIMILARLY, WITH OUR HPV ASSAYS, 2773 02:02:26,639 --> 02:02:30,210 ONE OF OUR FIRST REAL AREAS INTO 2774 02:02:30,210 --> 02:02:33,313 DIAGNOSTICS, WE HAVE A CARE HPV 2775 02:02:33,313 --> 02:02:36,883 TETEST THAT TAKES US DOWN TO SEF 2776 02:02:36,883 --> 02:02:38,484 SAMPLING INSTEAD OF HAVING TO GO 2777 02:02:38,484 --> 02:02:42,388 TO A GYNECOLOGIST TO OBTAIN THE 2778 02:02:42,388 --> 02:02:46,292 SAMPLE OR PAP SMEARS. 2779 02:02:46,292 --> 02:02:47,293 SO THESE ARE AREAS THAT WE'VE 2780 02:02:47,293 --> 02:02:48,027 COME THROUGH. 2781 02:02:48,027 --> 02:02:52,098 IN LIGHT OF THE PANDEMIC ALSO, 2782 02:02:52,098 --> 02:02:53,733 THE AWARENESS OF INFECTIOUS 2783 02:02:53,733 --> 02:02:55,435 DISEASE IDENTIFICATION FOR 2784 02:02:55,435 --> 02:02:57,770 PUBLIC HEALTH, MONITORING AND 2785 02:02:57,770 --> 02:02:59,973 IDENTIFICATION AND HELPING TO 2786 02:02:59,973 --> 02:03:01,841 BOTH SUPPORT AND START 2787 02:03:01,841 --> 02:03:05,778 RESPONDING FOR PANDEMICS IN A 2788 02:03:05,778 --> 02:03:07,614 FASTER, MORE EFFICIENT MANNER. 2789 02:03:07,614 --> 02:03:09,749 HAS INVOLVED US IN MANY MORE 2790 02:03:09,749 --> 02:03:10,817 PUBLIC HEALTH LABORATORIES, 2791 02:03:10,817 --> 02:03:14,153 MILITARY ORGANIZATIONS WHERE THE 2792 02:03:14,153 --> 02:03:15,922 PUBLIC HEALTH OF WAR FIGHTERS IS 2793 02:03:15,922 --> 02:03:17,257 IMPORTANT, AS WELL AS EMERGING 2794 02:03:17,257 --> 02:03:19,459 COUNTRIES THAT DO NOT 2795 02:03:19,459 --> 02:03:21,427 HAVE THE ACCESS TO SORT OF THE 2796 02:03:21,427 --> 02:03:23,162 MODERN MEDICAL LABORATORY 2797 02:03:23,162 --> 02:03:26,032 SYSTEMS THAT HELP REALLY -- 2798 02:03:26,032 --> 02:03:27,667 ENABLE THE WORLD TO RESPOND MORE 2799 02:03:27,667 --> 02:03:28,968 QUICKLY AND EFFECTIVELY AGAINST 2800 02:03:28,968 --> 02:03:30,069 EMERGING PATHOGENS. 2801 02:03:30,069 --> 02:03:33,573 WE ARE HEARING FROM GLOBAL 2802 02:03:33,573 --> 02:03:36,576 CLIMATE CHANGE EXPERTS AND 2803 02:03:36,576 --> 02:03:37,710 ENVIRONMENTAL AND ECOLOGISTS 2804 02:03:37,710 --> 02:03:39,279 THAT THIS IS CHANGING THE NATURE 2805 02:03:39,279 --> 02:03:42,215 OF ZOONOTIC INFECTIONS, WHERE 2806 02:03:42,215 --> 02:03:43,616 WE'RE LIKELY TO SEE MORE 2807 02:03:43,616 --> 02:03:45,952 TRANSFER OF ANIMAL PATHOGENS 2808 02:03:45,952 --> 02:03:47,487 INTERACTING WITH HUMANS, AND 2809 02:03:47,487 --> 02:03:48,554 THAT CLIMATE CHANGE IS ONE OF 2810 02:03:48,554 --> 02:03:51,291 THE THINGS THAT'S LEADING SOME 2811 02:03:51,291 --> 02:03:54,360 OF THESE CONTACTS BETWEEN THESE 2812 02:03:54,360 --> 02:03:55,561 THINGS SO THIS IS A WAY THAT WE 2813 02:03:55,561 --> 02:03:58,598 CAN HELP ADDRESS THAT. 2814 02:03:58,598 --> 02:04:00,066 FINALLY COMING BACK TO THE FACT 2815 02:04:00,066 --> 02:04:01,134 THAT, AS I MENTIONED, THE GLOBE 2816 02:04:01,134 --> 02:04:02,468 IS CHANGING, AND IT'S CHANGING 2817 02:04:02,468 --> 02:04:03,736 IN A VARIETY OF DIFFERENT WAYS 2818 02:04:03,736 --> 02:04:06,272 THAT WE HAVEN'T -- OVER THE LAST 2819 02:04:06,272 --> 02:04:11,844 10 YEARS THAT WE HAVE NOT SEEN 2820 02:04:11,844 --> 02:04:13,179 IN DECADES THAT FORMED THE END 2821 02:04:13,179 --> 02:04:14,681 OF OUR 20TH CENTURY. 2822 02:04:14,681 --> 02:04:16,416 TO HELP ADDRESS THIS, QIAGEN IS 2823 02:04:16,416 --> 02:04:19,052 VERY MUCH AWARE OF THE NEED TO 2824 02:04:19,052 --> 02:04:21,688 REDUCE OUR CARBON FOOTPRINT. 2825 02:04:21,688 --> 02:04:24,157 FOR BETTER OR FOR WORSE, THE 2826 02:04:24,157 --> 02:04:25,892 MEDICAL INDUSTRY, DIAGNOSTICS, 2827 02:04:25,892 --> 02:04:29,062 HAS BECOME ONE OF A -- REALLY 2828 02:04:29,062 --> 02:04:31,864 FOCUSED ON SINGLE USE PLASTICS. 2829 02:04:31,864 --> 02:04:34,200 AND PLASTIC AS A VERSATILE 2830 02:04:34,200 --> 02:04:35,368 MATERIAL HAS BEEN A REALLY 2831 02:04:35,368 --> 02:04:37,337 IMPORTANT PART, IF YOU LOOK AT 2832 02:04:37,337 --> 02:04:38,638 QIAGEN KITS, THE FIRST AMOUNT OF 2833 02:04:38,638 --> 02:04:40,406 WEIGHT IS ACTUALLY IN THE LIQUID 2834 02:04:40,406 --> 02:04:42,909 REAGENT BUFFERS, BUT THE NEXT 2835 02:04:42,909 --> 02:04:44,544 MASS OF THE KITS ARE TYPICALLY 2836 02:04:44,544 --> 02:04:46,079 IN PLASTICS. 2837 02:04:46,079 --> 02:04:48,614 THAT GOES NOT ONLY FOR THE 2838 02:04:48,614 --> 02:04:49,582 ACTUAL TUBES AND COLUMNS IN 2839 02:04:49,582 --> 02:04:52,418 THERE BUT ALSO HOW IT HAS BEEN 2840 02:04:52,418 --> 02:04:54,721 PACKAGED FROM THINGS LIKE ZIPLOC 2841 02:04:54,721 --> 02:04:56,055 BAGS TO BLISTER PACKS. 2842 02:04:56,055 --> 02:04:57,023 THESE ARE ALL EFFORTS THAT WE 2843 02:04:57,023 --> 02:05:01,260 ARE LOOKING AT AND EVALUATING 2844 02:05:01,260 --> 02:05:04,130 WAYS THAT WE CAN REDUCE OUR 2845 02:05:04,130 --> 02:05:07,433 CARBON FOOT PRINT, INCREASE 2846 02:05:07,433 --> 02:05:09,402 RECYCLABLITY TO OTHER MODES WE 2847 02:05:09,402 --> 02:05:12,905 CAN GO IN AND TO OVERALL REALLY 2848 02:05:12,905 --> 02:05:14,207 BE GOOD GLOBAL CITIZENS WHEN IT 2849 02:05:14,207 --> 02:05:15,274 COMES TO ENVIRONMENTAL 2850 02:05:15,274 --> 02:05:15,775 PRACTICES. 2851 02:05:15,775 --> 02:05:17,477 ON THE FRONT OF SOCIAL ON THERE, 2852 02:05:17,477 --> 02:05:19,779 WE ARE A GLOBAL COMPANY. 2853 02:05:19,779 --> 02:05:21,080 ONE OF THE THINGS I REALLY ENJOY 2854 02:05:21,080 --> 02:05:22,181 ABOUT BEING IN A GLOBAL COMPANY 2855 02:05:22,181 --> 02:05:25,585 IS THE EXPOSURE TO A VARIETY OF 2856 02:05:25,585 --> 02:05:27,987 CULTURES, AND THIS GOES BACK TO 2857 02:05:27,987 --> 02:05:30,823 MANY YEARS AND DECADES AS QIAGEN 2858 02:05:30,823 --> 02:05:31,591 HAS BEEN GLOBAL. 2859 02:05:31,591 --> 02:05:33,893 UNFORTUNATE THAT WE DO HAVE A 2860 02:05:33,893 --> 02:05:38,464 STRONG -- WE HAVE A STRONG 2861 02:05:38,464 --> 02:05:40,900 CULTURE THAT FOSTERS DIVERSE AND 2862 02:05:40,900 --> 02:05:41,634 AND INCLUSION AND THIS IS 2863 02:05:41,634 --> 02:05:42,535 SOMETHING THAT GOES ACROSS ALL 2864 02:05:42,535 --> 02:05:43,503 OF OUR ASPECTS OF BUSINESS. 2865 02:05:43,503 --> 02:05:44,804 WE'RE HAPPY TO SAY THAT WHEN WE 2866 02:05:44,804 --> 02:05:46,539 LOOK AT OUR WOMEN IN LEADERSHIP, 2867 02:05:46,539 --> 02:05:48,441 WE ARE MAKING IMPROVEMENTS IN 2868 02:05:48,441 --> 02:05:50,877 BRINGING THAT UP. 2869 02:05:50,877 --> 02:05:53,780 IF WERE TO LOOK AT GENDER 2870 02:05:53,780 --> 02:05:55,982 DISTRIBUTION ACROSS THE ENTIRE 2871 02:05:55,982 --> 02:06:00,219 COMPANY WE'RE RIGHT ABOUT AT 50% 2872 02:06:00,219 --> 02:06:01,120 FEMALE, 50% MALE ACCORDING TO 2873 02:06:01,120 --> 02:06:04,624 THE BINARY BUT ALSO VERY MUCH 2874 02:06:04,624 --> 02:06:06,125 INCLUSION AND ACTIVE COMMUNITY 2875 02:06:06,125 --> 02:06:07,126 OF PEOPLE THAT DO NOT FALL 2876 02:06:07,126 --> 02:06:08,561 WITHIN THE BINARY RANGE OF MALE 2877 02:06:08,561 --> 02:06:09,662 OR FEMALE ON THEM. 2878 02:06:09,662 --> 02:06:11,197 AS SCIENTISTS, WE RECOGNIZE THAT 2879 02:06:11,197 --> 02:06:13,266 THIS IS A SPECTRUM AND THAT THIS 2880 02:06:13,266 --> 02:06:14,467 IS IMPORTANT TO THESE PEOPLE TO 2881 02:06:14,467 --> 02:06:16,202 BRING THEIR THOUGHTS IN ORDER TO 2882 02:06:16,202 --> 02:06:18,538 MAINTAIN THE INNOVATIONS THAT WE 2883 02:06:18,538 --> 02:06:20,473 HAVE AND INJI NEWT THAT KEEPS US 2884 02:06:20,473 --> 02:06:22,575 AT THE FOREFRONT OF OUR 2885 02:06:22,575 --> 02:06:23,776 INDUSTRY. 2886 02:06:23,776 --> 02:06:26,946 FINALLY IN TERMS OF GOVERNANCE 2887 02:06:26,946 --> 02:06:27,914 ENSURING RESPONSIBILITY OF 2888 02:06:27,914 --> 02:06:28,948 CORPORATE PRACTICE, WE EXTEND 2889 02:06:28,948 --> 02:06:30,283 THAT OUT TO OUR SUPPLY CHAIN AS 2890 02:06:30,283 --> 02:06:33,019 WELL AS OUR EMPLOYEES AND HOW WE 2891 02:06:33,019 --> 02:06:34,153 HELP WORK WITH THOSE. 2892 02:06:34,153 --> 02:06:35,354 SUPPLY CHAIN HAS BEEN 2893 02:06:35,354 --> 02:06:36,756 PARTICULARLY IMPORTANT AS WE'VE 2894 02:06:36,756 --> 02:06:38,124 SEEN OVER THE LAST FIVE YEARS 2895 02:06:38,124 --> 02:06:40,626 NOW AND HOW THE PANDEMIC HAS 2896 02:06:40,626 --> 02:06:44,697 PROVIDED DISRUPTION ON GLOBAL 2897 02:06:44,697 --> 02:06:46,332 SUPPLY CHAIN, WE'VE SEEN HOW 2898 02:06:46,332 --> 02:06:47,967 WARS AND WARFARE ARE IMPACTING 2899 02:06:47,967 --> 02:06:48,935 SUPPLY CHAIN. 2900 02:06:48,935 --> 02:06:52,605 MOST RECENTLY WITH NOW THE 2901 02:06:52,605 --> 02:06:54,874 HOOTIE AND YEMEN APLAQUING 2902 02:06:54,874 --> 02:06:56,375 SUPPLY CHAIN GOING THROUGH THE 2903 02:06:56,375 --> 02:06:57,143 SUEZ AND RED SEA. 2904 02:06:57,143 --> 02:06:59,212 WE'VE ALSO SEE THAT IN SUPPLY 2905 02:06:59,212 --> 02:07:01,948 CHAIN AND CLIMATE IMPACTS WHERE 2906 02:07:01,948 --> 02:07:03,282 THE PANAMA CANAL IS HAVING TO 2907 02:07:03,282 --> 02:07:04,484 REDUCE THE NUMBER OF SHIPS THAT 2908 02:07:04,484 --> 02:07:05,551 CAN TRANSIT THE CANAL BECAUSE 2909 02:07:05,551 --> 02:07:07,186 THE DROUGHT IS LOWERING THE 2910 02:07:07,186 --> 02:07:10,122 LEVELS OF THE LAKES AND REDUCING 2911 02:07:10,122 --> 02:07:11,023 THE NUMBER -- 2912 02:07:11,023 --> 02:07:12,458 >> WE'RE GOING TO NEED TO ASK 2913 02:07:12,458 --> 02:07:15,761 YOU TO WRAP UP. 2914 02:07:15,761 --> 02:07:18,364 >> SO OVERALL, QIAGEN IS REALLY 2915 02:07:18,364 --> 02:07:20,433 WELL ABLE TO SUPPORT OUR 2916 02:07:20,433 --> 02:07:21,968 CUSTOMERS AS WE MOVE FORWARD, 2917 02:07:21,968 --> 02:07:23,269 AND I THANK YOU AGAIN FOR YOUR 2918 02:07:23,269 --> 02:07:25,338 TIME AND WELCOME THE OPPORTUNITY 2919 02:07:25,338 --> 02:07:26,672 TO ANSWER ANY QUESTIONS THAT YOU 2920 02:07:26,672 --> 02:07:27,974 HAVE DURING OUR DISCUSSION 2921 02:07:27,974 --> 02:07:30,977 SECTION. 2922 02:07:30,977 --> 02:07:33,446 >> I DO HAVE A QUESTION FOR THE 2923 02:07:33,446 --> 02:07:35,748 DIAGNOSTIC COMPANIES THAT WE 2924 02:07:35,748 --> 02:07:37,817 HAVE, BUT I'M GOING TO HOLD IT 2925 02:07:37,817 --> 02:07:38,918 UNTIL LAST TO SEE HOW MUCH TIME 2926 02:07:38,918 --> 02:07:41,320 WE HAVE LEFT. 2927 02:07:41,320 --> 02:07:43,489 SO FOR THE MOMENT, I'M GOING TO 2928 02:07:43,489 --> 02:07:47,226 GO ON TO JONATHAN COHEN, FOUNDER 2929 02:07:47,226 --> 02:07:54,166 AND CEO OF 2020 GENE SYSTEMS. 2930 02:07:54,166 --> 02:07:55,968 >> THANK YOU VERY MUCH, MICHAEL. 2931 02:07:55,968 --> 02:07:57,670 VERY NICE TO -- I APPRECIATE THE 2932 02:07:57,670 --> 02:08:00,006 OPPORTUNITY TO BE WITH YOU THIS 2933 02:08:00,006 --> 02:08:03,509 AFTERNOON. 2934 02:08:03,509 --> 02:08:04,510 I'M GOING TO SHARE A COUPLE OF 2935 02:08:04,510 --> 02:08:05,077 SLIDES. 2936 02:08:05,077 --> 02:08:06,279 I ASSUME THOSE ARE VISIBLE AT 2937 02:08:06,279 --> 02:08:10,883 THIS POINT? 2938 02:08:10,883 --> 02:08:11,517 >> YES. 2939 02:08:11,517 --> 02:08:12,718 >> SO WE ARE LOCATED JUST 2940 02:08:12,718 --> 02:08:14,587 OUTSIDE OF OUR NATION'S CAPITOL 2941 02:08:14,587 --> 02:08:20,092 IN GAIT BU GAITHERSBURG, MARYLA. 2942 02:08:20,092 --> 02:08:21,193 >> WE'RE SEEING YOUR DECK BUT 2943 02:08:21,193 --> 02:08:22,461 IT'S NOT IN PRESENTATION MODE. 2944 02:08:22,461 --> 02:08:23,229 >> THANK YOU FOR THAT. 2945 02:08:23,229 --> 02:08:33,506 IS THAT BETTER? 2946 02:08:34,040 --> 02:08:34,607 >> THAT IS GREAT. 2947 02:08:34,607 --> 02:08:35,007 THANK YOU. 2948 02:08:35,007 --> 02:08:36,142 >> THANK YOU FOR THAT. 2949 02:08:36,142 --> 02:08:38,978 I WANT TO TOUCH ON A LITTLE BIT 2950 02:08:38,978 --> 02:08:40,179 ABOUT OUR COMPANY AND OUR 2951 02:08:40,179 --> 02:08:44,550 RELATIONSHIP WITH THE NIH, WHICH 2952 02:08:44,550 --> 02:08:45,851 IS LOCATED ONLY A COUPLE MILES 2953 02:08:45,851 --> 02:08:49,488 FROM US, BECAUSE WE'VE HAD A 2954 02:08:49,488 --> 02:08:50,890 VARIED ARRAY OF INTERACTIONS 2955 02:08:50,890 --> 02:08:53,426 OVER THE YEARS. 2956 02:08:53,426 --> 02:08:54,794 FIRST OF ALL, WE ARE A CLINICAL 2957 02:08:54,794 --> 02:08:58,030 LAB COMPANY, SO WHILE REALLY 2958 02:08:58,030 --> 02:08:59,966 THERE'S TWO TYPES OF DIAGNOSTICS 2959 02:08:59,966 --> 02:09:03,069 COMPANIES, THERE ARE COMPANIES 2960 02:09:03,069 --> 02:09:04,370 LIKE QIAGEN THAT YOU JUST HEARD 2961 02:09:04,370 --> 02:09:06,572 FROM THAT MAKE AND SELL KITS, 2962 02:09:06,572 --> 02:09:10,476 BUT USUALLY VERY OFTEN, THOSE 2963 02:09:10,476 --> 02:09:14,647 KITS ARE USED BY HIGH 2964 02:09:14,647 --> 02:09:16,382 COMPLEXITY -- WHICH WERE 2965 02:09:16,382 --> 02:09:17,450 REFERRED TO AND WE ARE ONE SUCH 2966 02:09:17,450 --> 02:09:17,850 LAB. 2967 02:09:17,850 --> 02:09:19,118 SO WE DEVELOP AND COMMERCIALIZE 2968 02:09:19,118 --> 02:09:20,653 WHAT ARE CALLED LAB-DEVELOPED 2969 02:09:20,653 --> 02:09:23,522 TESTS. 2970 02:09:23,522 --> 02:09:25,791 AND WE HAVE LICENSURE FROM BOTH 2971 02:09:25,791 --> 02:09:33,432 CLIE YA, WCLIA, COLLEGE OF AMERN 2972 02:09:33,432 --> 02:09:34,433 PATHOLOGISTS, WE HAVE 2973 02:09:34,433 --> 02:09:35,635 HISTORICALLY HAD A FOCUS ON 2974 02:09:35,635 --> 02:09:36,969 EARLY CANCER DETECTION AND THAT 2975 02:09:36,969 --> 02:09:38,804 REMAINS SO. 2976 02:09:38,804 --> 02:09:40,673 WE LIKE MANY LABS PIVOTED DURING 2977 02:09:40,673 --> 02:09:42,975 THE PANDEMIC AND WERE A BIG 2978 02:09:42,975 --> 02:09:45,878 PROVIDER OF COVID PCR TESTS HERE 2979 02:09:45,878 --> 02:09:48,981 IN MARYLAND AND IN THIS REGION. 2980 02:09:48,981 --> 02:09:50,850 WE BECAME ACTUALLY THIS YEAR, WE 2981 02:09:50,850 --> 02:09:53,252 WERE RANKED NUMBER ONE FASTEST 2982 02:09:53,252 --> 02:09:55,454 GROWING COMPANY IN THE STATE OF 2983 02:09:55,454 --> 02:09:56,889 MARYLAND BY REVENUE, LARGELY 2984 02:09:56,889 --> 02:09:58,758 BECAUSE OF OUR COVID TESTING 2985 02:09:58,758 --> 02:10:03,229 LAST YEAR. 2986 02:10:03,229 --> 02:10:04,430 BUT OUR MAIN FOCUS NOW IS 2987 02:10:04,430 --> 02:10:08,467 SOMETHING CALLED AN MSAD. 2988 02:10:08,467 --> 02:10:10,569 HERE IN WASHINGTON WHEN SOMEBODY 2989 02:10:10,569 --> 02:10:11,704 BECOMES IMPORTANT, IT GETS AN 2990 02:10:11,704 --> 02:10:12,004 ACRONYM. 2991 02:10:12,004 --> 02:10:13,739 THIS ACRONYM STANDS FOR 2992 02:10:13,739 --> 02:10:16,242 MULTI-CANCER EARLY DETECTION. 2993 02:10:16,242 --> 02:10:20,579 THIS WAS AN APPROACH PIONEERED 2994 02:10:20,579 --> 02:10:27,653 BY A COMPANY THAT HAS AN MCED ON 2995 02:10:27,653 --> 02:10:28,988 THE MARKET, OURS IS VERY 2996 02:10:28,988 --> 02:10:30,556 DIFFERENT BUT PRIMARILY BASED ON 2997 02:10:30,556 --> 02:10:31,724 PROTEINS, NOT CIRCULATING TUMOR 2998 02:10:31,724 --> 02:10:37,163 DNA. 2999 02:10:37,163 --> 02:10:38,364 I'M ALSO GOING TO MENTION ABOUT 3000 02:10:38,364 --> 02:10:39,765 AN ENTITY THAT WE HAVE THAT I 3001 02:10:39,765 --> 02:10:42,501 BELIEVE IS UNIQUE AND COULD BE 3002 02:10:42,501 --> 02:10:44,036 OF INTEREST TO SOME IN THE 3003 02:10:44,036 --> 02:10:44,704 AUDIENCE THIS AFTERNOON. 3004 02:10:44,704 --> 02:10:46,038 WE HAVE CREATED WHAT WE THINK IS 3005 02:10:46,038 --> 02:10:49,475 THE FIRST ACCELERATOR FACILITY 3006 02:10:49,475 --> 02:10:52,945 FOR COMPANIES THAT ARE DEVEL 3007 02:10:52,945 --> 02:10:54,313 DEVELOPING OR HAVE DEVELOPED 3008 02:10:54,313 --> 02:10:55,981 LAB-DEVELOPED TESTS OR LDTs 3009 02:10:55,981 --> 02:10:59,485 THAT WANT TO LAUNCH IN THE 3010 02:10:59,485 --> 02:11:00,820 UNITED STATES MARKET WITHOUT THE 3011 02:11:00,820 --> 02:11:02,855 COST AND BURDEN OF EITHER 3012 02:11:02,855 --> 02:11:04,657 GETTING AN FDA APPROVAL FOR A 3013 02:11:04,657 --> 02:11:08,360 KIT, AN IVD KIT, OR BUILDING OUT 3014 02:11:08,360 --> 02:11:10,529 THEIR OWN LAB AND STAFFING IT 3015 02:11:10,529 --> 02:11:12,198 AND EQUIPPING IT. 3016 02:11:12,198 --> 02:11:13,933 SO I JUST HAVE A FEW SLIDES TO 3017 02:11:13,933 --> 02:11:16,435 SHARE WITH YOU. 3018 02:11:16,435 --> 02:11:20,806 I KNOW THAT WE'RE SHORT ON TIME. 3019 02:11:20,806 --> 02:11:24,977 THE MCED, SINCE THIS IS AN NIH 3020 02:11:24,977 --> 02:11:27,713 SYMPOSIUM, I WOULD LIKE TO SPEND 3021 02:11:27,713 --> 02:11:29,348 A LITTLE TIME ON THE 3022 02:11:29,348 --> 02:11:32,551 GOVERNMENT'S INTEREST IN 3023 02:11:32,551 --> 02:11:33,486 MCEDs, AND AS WE OFTEN SAY 3024 02:11:33,486 --> 02:11:36,555 HERE IN WASHINGTON, BOTH SIDES 3025 02:11:36,555 --> 02:11:38,424 OF PENNSYLVANIA AVENUE HAVE 3026 02:11:38,424 --> 02:11:39,759 EXPRESSED INTEREST -- OR NOT 3027 02:11:39,759 --> 02:11:41,927 JUST EXPRESSED INTEREST, HAVE 3028 02:11:41,927 --> 02:11:46,732 TAKEN ACTION TO ADVANCE THIS 3029 02:11:46,732 --> 02:11:47,166 FIELD. 3030 02:11:47,166 --> 02:11:51,103 CONGRESS HAS A BILL THAT HAS 3031 02:11:51,103 --> 02:11:51,871 REMARKABLE BIPARTISAN SUPPORT, 3032 02:11:51,871 --> 02:11:55,374 WELL OVER 200 MEMBERS, SENATE 3033 02:11:55,374 --> 02:11:57,676 AND HOUSE, REPUBLICAN AND 3034 02:11:57,676 --> 02:11:59,545 DEMOCRAT, TO CREATE A PATHWAY 3035 02:11:59,545 --> 02:12:05,985 FOR CMS TO COVER THESE TESTS, 3036 02:12:05,985 --> 02:12:10,189 AND TO STORE S SHORTEN THE TIMEE 3037 02:12:10,189 --> 02:12:10,689 ASSOCIATED WITH THAT. 3038 02:12:10,689 --> 02:12:13,192 THEY HAVE INCLUDED PRESIDENT 3039 02:12:13,192 --> 02:12:14,093 BIDEN'S CANCER MOONSHOT PROGRAM 3040 02:12:14,093 --> 02:12:15,294 AS A PRIORITY AND FUNDING FROM 3041 02:12:15,294 --> 02:12:18,697 THAT PROGRAM HAS FLOWED TO THE 3042 02:12:18,697 --> 02:12:21,300 U.S. NCI NATIONAL CANCER 3043 02:12:21,300 --> 02:12:23,269 INSTITUTE, MICHAEL'S 3044 02:12:23,269 --> 02:12:26,872 ORGANIZATION, TO BASICALLY 3045 02:12:26,872 --> 02:12:28,374 SUPPORT RANDOMIZED CLINICAL 3046 02:12:28,374 --> 02:12:30,442 TRIALS. 3047 02:12:30,442 --> 02:12:33,879 PROGRAM KNOWN AS VANGUARD AND 3048 02:12:33,879 --> 02:12:35,281 THEY'RE GOING TO BE SELECTING A 3049 02:12:35,281 --> 02:12:39,351 SMALL NUMBER OF MCEDs FOR THAT 3050 02:12:39,351 --> 02:12:42,087 PROGRAM. 3051 02:12:42,087 --> 02:12:44,356 THAT PROCESS OF SELECTION IS 3052 02:12:44,356 --> 02:12:44,924 UNDERWAY. 3053 02:12:44,924 --> 02:12:48,961 WE ARE PART OF IT, AND WE ARE 3054 02:12:48,961 --> 02:12:52,898 HOPING TO BE -- TO HAVE A TEST 3055 02:12:52,898 --> 02:12:56,635 THAT IS DEEMED TO BE COMPETITIVE 3056 02:12:56,635 --> 02:12:58,070 AND WORTHY OF PARTICIPATION IN 3057 02:12:58,070 --> 02:13:02,975 THIS VERY IMPORTANT LONG -- IT 3058 02:13:02,975 --> 02:13:04,743 WILL TAKE MANY YEARS, BUT 3059 02:13:04,743 --> 02:13:05,344 RANDOMIZED CLINICAL TRIALS TO 3060 02:13:05,344 --> 02:13:08,113 SHOW THAT THESE TESTS ULTIMATELY 3061 02:13:08,113 --> 02:13:09,748 SAVE LIVES FOR MANY DIFFERENT 3062 02:13:09,748 --> 02:13:13,152 CANCERS AND ALSO HAVE VALUE TO 3063 02:13:13,152 --> 02:13:16,956 THE HEALTHCARE SYSTEM. 3064 02:13:16,956 --> 02:13:18,858 OUR TEST IS DIFFERENT THAN MOST 3065 02:13:18,858 --> 02:13:20,259 OF THE COMPETING TESTS THAT WE 3066 02:13:20,259 --> 02:13:25,030 KNOW OF IN THAT IT IS MAINLY 3067 02:13:25,030 --> 02:13:25,631 PROTEIN-BASED. 3068 02:13:25,631 --> 02:13:26,799 WE DO ALSO INCLUDE SOME 3069 02:13:26,799 --> 02:13:28,901 INFLAMMATORY AND METABOLIC 3070 02:13:28,901 --> 02:13:31,203 MARKERS, AND IT'S GROWING RATHER 3071 02:13:31,203 --> 02:13:31,503 FAST. 3072 02:13:31,503 --> 02:13:35,007 WE SELL THE TEST, IT'S ON THE 3073 02:13:35,007 --> 02:13:36,642 MARKET, ONE TEST FOR CANCER.COM. 3074 02:13:36,642 --> 02:13:41,914 WE GET, OH, YOU KNOW, 15 OR SO 3075 02:13:41,914 --> 02:13:45,284 DIRECT CONSUMER ORDERS A DAY. 3076 02:13:45,284 --> 02:13:46,385 WE USE TELEMEDICINE. 3077 02:13:46,385 --> 02:13:48,554 THERE ARE 600 PLACES PEOPLE CAN 3078 02:13:48,554 --> 02:13:51,090 GET A BLOOD DRAW THROUGHOUT THE 3079 02:13:51,090 --> 02:13:51,657 UNITED STATES. 3080 02:13:51,657 --> 02:13:55,461 WE ALSO SELL TO EMPLOYERS, AND 3081 02:13:55,461 --> 02:13:57,763 SOME MEDICAL ORGANIZATIONS THAT 3082 02:13:57,763 --> 02:13:59,832 SPECIALIZE IN PREVENTION AND 3083 02:13:59,832 --> 02:14:01,066 LIFESTYLE MEDICINE. 3084 02:14:01,066 --> 02:14:03,235 AND ALSO OCCUPATIONAL HEALTH. 3085 02:14:03,235 --> 02:14:06,939 THE EMPLOYERS ARE TYPICALLY ONES 3086 02:14:06,939 --> 02:14:09,375 WHERE THEIR EMPLOYEES ARE 3087 02:14:09,375 --> 02:14:12,444 BELIEVED TO HAVE HIGHER 3088 02:14:12,444 --> 02:14:13,712 INCIDENCE IN DEATH FOR A VARIETY 3089 02:14:13,712 --> 02:14:14,947 OF CANCERS, SUCH AS FIRE 3090 02:14:14,947 --> 02:14:15,915 DEPARTMENTS. 3091 02:14:15,915 --> 02:14:17,249 FIRE DEPARTMENTS COMPRISE CLOSE 3092 02:14:17,249 --> 02:14:19,652 TO HALF OF OUR CUSTOMERS AT THIS 3093 02:14:19,652 --> 02:14:20,419 POINT THROUGHOUT THE UNITED 3094 02:14:20,419 --> 02:14:23,589 STATES. 3095 02:14:23,589 --> 02:14:25,224 AND WE USE MACHINE LEARNING 3096 02:14:25,224 --> 02:14:26,992 ALGORITHMS BUILT FROM DATA IN 3097 02:14:26,992 --> 02:14:29,695 PART OF THE WORLD, NAMELY THE 3098 02:14:29,695 --> 02:14:31,263 FAR EAST, WHERE THESE TESTS ARE 3099 02:14:31,263 --> 02:14:34,199 NOT JUST COMMON BUT UNIVERSAL. 3100 02:14:34,199 --> 02:14:36,235 AND WE HAVE DEMONSTRATED THAT 3101 02:14:36,235 --> 02:14:39,038 THESE ALGORITHMS SUBSTANTIALLY 3102 02:14:39,038 --> 02:14:43,142 IMPROVE DIAGNOSTIC ACCURACY. 3103 02:14:43,142 --> 02:14:45,344 OUR ADVANTAGES OVER THE GALLERY 3104 02:14:45,344 --> 02:14:48,314 TEST FROM GRAIL AND OTHER 3105 02:14:48,314 --> 02:14:50,382 EMERGING CT DNA ARE THE 3106 02:14:50,382 --> 02:14:51,917 PROVERBIAL BETTER, FASTER, 3107 02:14:51,917 --> 02:14:55,387 CHEAPER, BETTER ACCURACY FOR 3108 02:14:55,387 --> 02:14:59,358 EARLY STAGE CANCERS, MORE 3109 02:14:59,358 --> 02:15:00,025 SENSITIVE, WHICH IS WHAT YOU 3110 02:15:00,025 --> 02:15:05,264 WANT IN A SCREENING TEST. 3111 02:15:05,264 --> 02:15:11,036 AND ALSO FASTER ACCESS BY VIRTUE 3112 02:15:11,036 --> 02:15:12,805 OF OUR RECENT VALIDATIONS OF THE 3113 02:15:12,805 --> 02:15:14,740 TEST WITH CAPILLARY BLOOD, WE 3114 02:15:14,740 --> 02:15:16,175 ACTUALLY ARE MOVING THE TEST 3115 02:15:16,175 --> 02:15:19,144 INTO PHARMACY COUNTERS, AT 3116 02:15:19,144 --> 02:15:19,845 SUPERMARKET CHAINS. 3117 02:15:19,845 --> 02:15:22,848 WE HAVE ONE AGREEMENT IN PLACE 3118 02:15:22,848 --> 02:15:25,284 ALREADY. 3119 02:15:25,284 --> 02:15:26,352 IN THE SECOND QUARTER, WE EXPECT 3120 02:15:26,352 --> 02:15:27,987 TO HAVE THAT AT LEAST AS A 3121 02:15:27,987 --> 02:15:30,089 PILOT, SO EASY ACCESS THROUGH 3122 02:15:30,089 --> 02:15:32,958 CAPILLARY COLLECTION, EVENTUALLY 3123 02:15:32,958 --> 02:15:34,093 HOME-BASED, WHICH WOULD BE HARD 3124 02:15:34,093 --> 02:15:37,162 TO DO WITH CT DNA, WHICH 3125 02:15:37,162 --> 02:15:41,433 TYPICALLY REQUIRES MORE PLASMA, 3126 02:15:41,433 --> 02:15:42,234 AND MUCH CHEAPER. 3127 02:15:42,234 --> 02:15:46,305 THESE TESTS -- OUR TEST IS UNDER 3128 02:15:46,305 --> 02:15:49,208 $200 FOR THE BASIC VERSION, 3129 02:15:49,208 --> 02:15:51,076 VERSUS $1,000 FOR THE GRAIL 3130 02:15:51,076 --> 02:15:52,611 GALLERY TEST. 3131 02:15:52,611 --> 02:16:01,353 SO IT'S BETTER, FASTER, CHEAPER. 3132 02:16:01,353 --> 02:16:02,554 I WANT TO COME BACK TO THE 3133 02:16:02,554 --> 02:16:06,592 ENTITY THAT I MENTIONED IN MY 3134 02:16:06,592 --> 02:16:09,128 INTRODUCTION, WHAT WE CALL 3135 02:16:09,128 --> 02:16:10,996 CLIAX, CLINICAL LAB INNOVATION 3136 02:16:10,996 --> 02:16:11,530 ACCELERATOR. 3137 02:16:11,530 --> 02:16:13,165 WE, WORKING WITH REGULATORY 3138 02:16:13,165 --> 02:16:15,467 COUNCIL, HAVE COME UP WITH A 3139 02:16:15,467 --> 02:16:18,771 COMPLIANT MODEL THAT ALLOWS US 3140 02:16:18,771 --> 02:16:19,972 TO ESSENTIALLY SHARE OUR SPACE, 3141 02:16:19,972 --> 02:16:26,879 OUR EQUIPMENT, OUR LICENSURE, 3142 02:16:26,879 --> 02:16:29,248 AND THE IDEA IS THAT A COMPANY 3143 02:16:29,248 --> 02:16:31,016 THAT EITHER BECAUSE OF THEIR 3144 02:16:31,016 --> 02:16:33,652 SIZE OR THEIR GEOGRAPHY, AN 3145 02:16:33,652 --> 02:16:34,720 OVERSEAS COMPANY, FOR EXAMPLE, 3146 02:16:34,720 --> 02:16:35,921 TO COME INTO THE UNITED STATES 3147 02:16:35,921 --> 02:16:40,526 AND TO LEASE SPACE, TO EQUIP IT 3148 02:16:40,526 --> 02:16:41,860 WITH EXPENSIVE INSTRUMENTATION 3149 02:16:41,860 --> 02:16:46,865 FROM COMPANIES LIKE QIAGEN OR 3150 02:16:46,865 --> 02:16:48,500 OTHERS, TO STAFF IT WITH THE 3151 02:16:48,500 --> 02:16:51,003 PERSONNEL THAT ARE REQUIRED 3152 02:16:51,003 --> 02:16:54,540 UNDER CLIA CAN BE FORMIDABLE. 3153 02:16:54,540 --> 02:16:56,508 AND THE IDEA WOULD BE TO -- WE 3154 02:16:56,508 --> 02:16:58,343 HAVE CREATED A TURNKEY SOLUTION. 3155 02:16:58,343 --> 02:17:00,079 RIGHT NOW WE HAVE ONE COMPANY 3156 02:17:00,079 --> 02:17:01,413 FROM AUSTRALIA THAT LAUNCHED 3157 02:17:01,413 --> 02:17:07,119 THEIR PRODUCT THROUGH OUR CLIA 3158 02:17:07,119 --> 02:17:09,521 X, IT HAPPENS TO FOCUS ON 3159 02:17:09,521 --> 02:17:10,622 PROSTATE CANCER, BUT WE ARE 3160 02:17:10,622 --> 02:17:13,859 INTERESTED IN OTHERS BUT WE ARE 3161 02:17:13,859 --> 02:17:14,493 PARTICULARLY LOOKING FOR 3162 02:17:14,493 --> 02:17:17,629 COMPANIES THAT WE CAN HELP SELL 3163 02:17:17,629 --> 02:17:19,164 THEIR PRODUCT, THEIR TESTS TO 3164 02:17:19,164 --> 02:17:20,766 OUR CUSTOMERS. 3165 02:17:20,766 --> 02:17:24,803 OF WHICH WE NOW HAVE ABOUT 3166 02:17:24,803 --> 02:17:29,408 15,000, BUT THESE ARE TESTS FOR 3167 02:17:29,408 --> 02:17:30,809 WELLNESS PREVENTION SCREENING 3168 02:17:30,809 --> 02:17:33,912 EARLY DETECTION, NOT FOR PEOPLE 3169 02:17:33,912 --> 02:17:35,881 WITH A CONFIRMED DIAGNOSIS THAT 3170 02:17:35,881 --> 02:17:38,283 ARE BEING TREATED, EITHER AT A 3171 02:17:38,283 --> 02:17:41,553 HOSPITAL OR OUTPATIENT. 3172 02:17:41,553 --> 02:17:43,088 THAT IS NOT OUR FOCUS. 3173 02:17:43,088 --> 02:17:44,389 WE DO NOT HAVE A SALES TEAM THAT 3174 02:17:44,389 --> 02:17:48,660 CALLS ON MEDICAL SPECIALISTS. 3175 02:17:48,660 --> 02:17:50,062 SO THINGS LIKE EARLY DETECTION 3176 02:17:50,062 --> 02:17:52,164 OF CARDIOVASCULAR DISEASE, 3177 02:17:52,164 --> 02:17:54,767 ALZHEIMER'S, WE ARE VERY, VERY 3178 02:17:54,767 --> 02:17:57,302 INTERESTED IN NUTRITION AND FOOD 3179 02:17:57,302 --> 02:17:58,737 AS MEDICINE. 3180 02:17:58,737 --> 02:18:03,642 WAYS PEOPLE CAN IMPROVE THEIR -- 3181 02:18:03,642 --> 02:18:07,813 BOTH THE LONGEVITY AND QUALITY 3182 02:18:07,813 --> 02:18:10,015 OF LIFE THROUGH A HEALTHY DIET 3183 02:18:10,015 --> 02:18:13,519 AND EXERCISE PROGRAM. 3184 02:18:13,519 --> 02:18:16,555 BIOMARKERS ASSOCIATED WITH 3185 02:18:16,555 --> 02:18:19,491 AGING, SUCH AS INFLAMMATORY 3186 02:18:19,491 --> 02:18:22,694 MARKERS AND TELOMERE LENGTH AND 3187 02:18:22,694 --> 02:18:23,028 THE LIKE. 3188 02:18:23,028 --> 02:18:24,263 THESE ARE THE PRODUCTS THAT WE 3189 02:18:24,263 --> 02:18:27,933 WOULD LIKE TO HELP LAUNCH AND 3190 02:18:27,933 --> 02:18:32,204 MARKET IN THE UNITED STATES TO 3191 02:18:32,204 --> 02:18:34,840 OUR CUSTOMERS FOR WELLNESS, 3192 02:18:34,840 --> 02:18:38,644 EARLY DETECTION PREVENTION. 3193 02:18:38,644 --> 02:18:41,847 AND I WOULD ALSO LIKE JUST TO IN 3194 02:18:41,847 --> 02:18:43,415 CLOSING, I'D BE REMISS NOT TO 3195 02:18:43,415 --> 02:18:44,683 POINT OUT THAT WE HAVE HAD A 3196 02:18:44,683 --> 02:18:46,451 LONG AND PRODUCTIVE HISTORY OF 3197 02:18:46,451 --> 02:18:47,853 WORKING WITH NIH AT DIFFERENT 3198 02:18:47,853 --> 02:18:50,355 LEVELS, SO EARLY IN OUR COMPANY 3199 02:18:50,355 --> 02:18:52,324 LIFE, WE HAD WHAT'S CALLED A 3200 02:18:52,324 --> 02:18:53,792 CRADA, COOPERATIVE RESEARCH AND 3201 02:18:53,792 --> 02:18:54,459 DEVELOPMENT AGREEMENT. 3202 02:18:54,459 --> 02:18:57,229 WE ACTUALLY -- OUR FIRST LAB WAS 3203 02:18:57,229 --> 02:19:00,866 IN AN NIH NCI FACILITY IN 3204 02:19:00,866 --> 02:19:01,266 GAITHERSBURG. 3205 02:19:01,266 --> 02:19:03,268 WE HAD THAT FOR ABOUT TWO YEARS. 3206 02:19:03,268 --> 02:19:07,406 WE ACTUALLY HAD SOME BE BENCH SE 3207 02:19:07,406 --> 02:19:08,207 THERE. 3208 02:19:08,207 --> 02:19:10,175 WE HAD LICENSE AGREEMENTS WITH 3209 02:19:10,175 --> 02:19:11,677 NIH AND WE HAD BEEN THE 3210 02:19:11,677 --> 02:19:13,679 RECIPIENT OF SEVERAL MILLION 3211 02:19:13,679 --> 02:19:19,484 DOLLARS OF SBIR GRANTS AND 3212 02:19:19,484 --> 02:19:19,985 CONTRACTS. 3213 02:19:19,985 --> 02:19:20,652 NOT RECENTLY. 3214 02:19:20,652 --> 02:19:22,854 THESE GO BACK SEVEN, EIGHT, NINE 3215 02:19:22,854 --> 02:19:24,456 YEARS, BUT AT VARIOUS POINTS IN 3216 02:19:24,456 --> 02:19:26,458 OUR TRAJECTORY, IN OUR COMPANY'S 3217 02:19:26,458 --> 02:19:27,192 TRAJECTORY, THEY WERE VERY 3218 02:19:27,192 --> 02:19:27,859 IMPORTANT. 3219 02:19:27,859 --> 02:19:34,433 SO LICENSE AGREEMENTS, CRADAs, 3220 02:19:34,433 --> 02:19:36,301 SBIR GRANTS, AND HOPEFULLY THIS 3221 02:19:36,301 --> 02:19:38,036 VANGUARD PROGRAM, VERY EXCITING 3222 02:19:38,036 --> 02:19:40,138 VANGUARD PROGRAM THAT I REFERRED 3223 02:19:40,138 --> 02:19:41,573 TO, WHICH IS SUPPORTED BY THE 3224 02:19:41,573 --> 02:19:43,175 WHITE HOUSE CANCER MOONSHOT, IS 3225 02:19:43,175 --> 02:19:46,345 SOMETHING ELSE THAT WE ARE 3226 02:19:46,345 --> 02:19:48,580 HOPING TO PARTICIPATE IN. 3227 02:19:48,580 --> 02:19:50,282 AND THEN FINALLY, THIS CLINICAL 3228 02:19:50,282 --> 02:19:53,652 LAB INNOVATION AK SE RAY TORE 3229 02:19:53,652 --> 02:19:55,654 CAN CERTAINLY FIT, WE HAVE HAD 3230 02:19:55,654 --> 02:19:56,889 INQUIRIES FROM THE NIH'S 3231 02:19:56,889 --> 02:19:57,589 INTRAMURAL PROGRAM. 3232 02:19:57,589 --> 02:20:00,926 NOTHING THAT HAS SO FAR 3233 02:20:00,926 --> 02:20:03,295 MATERIALIZED, BUT THIS COULD BE 3234 02:20:03,295 --> 02:20:05,931 SOMETHING THAT AN NIH 3235 02:20:05,931 --> 02:20:07,532 INVESTIGATOR THAT WOULD LIKE TO 3236 02:20:07,532 --> 02:20:08,867 COMMERCIALIZE THEIR ASSAY, IF 3237 02:20:08,867 --> 02:20:12,304 THEY BELIEVE THERE IS A MARKET, 3238 02:20:12,304 --> 02:20:14,072 WE WOULD LIKE TO HEAR FROM THEM. 3239 02:20:14,072 --> 02:20:17,442 AS WELL AS EXTRAMURAL GRANTEES 3240 02:20:17,442 --> 02:20:22,914 AND LICENSEES FROM THE NIH. 3241 02:20:22,914 --> 02:20:23,882 SO THAT CONCLUDES MY 3242 02:20:23,882 --> 02:20:24,549 PRESENTATION. 3243 02:20:24,549 --> 02:20:27,719 MY CONTACT INFORMATION MAY BE -- 3244 02:20:27,719 --> 02:20:30,555 IS VISIBLE ON THIS SLIDE. 3245 02:20:30,555 --> 02:20:31,623 AND I CERTAINLY WILL LOOK 3246 02:20:31,623 --> 02:20:34,359 FORWARD TO ANY QUESTIONS. 3247 02:20:34,359 --> 02:20:36,895 THANK YOU FOR YOUR TIME THIS 3248 02:20:36,895 --> 02:20:39,231 AFTERNOON. 3249 02:20:39,231 --> 02:20:40,565 >> THANK YOU VERY MUCH, 3250 02:20:40,565 --> 02:20:40,999 JONATHAN. 3251 02:20:40,999 --> 02:20:42,267 YES, WE'LL HAVE A COUPLE 3252 02:20:42,267 --> 02:20:46,905 QUESTIONS AT THE END. 3253 02:20:46,905 --> 02:20:48,674 FOR THE MOMENT, WE'RE GOING TO 3254 02:20:48,674 --> 02:20:50,342 MOVE ON TO DR. TOM NUTMAN, 3255 02:20:50,342 --> 02:20:51,843 SENIOR INVESTIGATOR AT THE 3256 02:20:51,843 --> 02:20:54,246 NATIONAL INSTITUTE OF ALLERGY 3257 02:20:54,246 --> 02:21:02,587 AND INFECTIOUS DISEASES. 3258 02:21:02,587 --> 02:21:03,455 >> THANK YOU VERY MUCH. 3259 02:21:03,455 --> 02:21:06,391 I ASSUME YOU CAN SEE MY SLIDES. 3260 02:21:06,391 --> 02:21:07,592 I THINK I'M A LITTLE BIT OF A 3261 02:21:07,592 --> 02:21:10,562 FISH OUT OF WATER HERE IN THIS 3262 02:21:10,562 --> 02:21:11,196 SESSION. 3263 02:21:11,196 --> 02:21:16,134 BUT I'M GOING TO TALK ABOUT, I 3264 02:21:16,134 --> 02:21:20,706 THINK, SOME INNOVATIONS THAT WE 3265 02:21:20,706 --> 02:21:24,009 IDENTIFIED AND THEN HOW WE 3266 02:21:24,009 --> 02:21:26,511 OVERCAME WHAT I'LL CALL ROAD 3267 02:21:26,511 --> 02:21:27,746 BLOCKS FOR PUBLIC HEALTH 3268 02:21:27,746 --> 02:21:28,714 DIAGNOSTIC NEEDS AND I'M GOING 3269 02:21:28,714 --> 02:21:34,252 TO USE THIS -- I'M GOING TO USE 3270 02:21:34,252 --> 02:21:36,822 A VERY SET OF SERIOUS PARASITIC 3271 02:21:36,822 --> 02:21:40,025 INFECTIONS CALLED THE FILARIAL 3272 02:21:40,025 --> 02:21:41,760 INFECTIONS TO SORT OF ILLUSTRATE 3273 02:21:41,760 --> 02:21:44,830 THE PROBLEMS AND HOW ONE CAN 3274 02:21:44,830 --> 02:21:47,199 OVERCOME THEM FOR ULTIMATELY 3275 02:21:47,199 --> 02:21:51,303 POINT OF CARE DIAGNOSTICS. 3276 02:21:51,303 --> 02:21:53,238 SO I STUDIED AND HAVE STUDIED 3277 02:21:53,238 --> 02:21:55,140 FOR ALMOST MY ENTIRE CAREER 3278 02:21:55,140 --> 02:21:56,208 THESE NEGLECTED TROPICAL 3279 02:21:56,208 --> 02:21:57,409 DISEASES, AND THESE ARE 3280 02:21:57,409 --> 02:22:00,178 NEGLECTED NOT ONLY BY FUNDING 3281 02:22:00,178 --> 02:22:04,082 AGENCIES, BUT ALSO BY MOST 3282 02:22:04,082 --> 02:22:06,084 MINISTRIES OF HEALTH IN THE 3283 02:22:06,084 --> 02:22:11,223 AREAS WHERE THESE EXIST TWO OF 3284 02:22:11,223 --> 02:22:14,593 THE INFECTIONS I'M GOING TO TALK 3285 02:22:14,593 --> 02:22:15,827 ABOUT TODAY, I'LL EXPLAIN A 3286 02:22:15,827 --> 02:22:16,762 LITTLE BIT ABOUT WHAT THEY ARE 3287 02:22:16,762 --> 02:22:19,297 IN A SECOND, BUT YOU CAN SEE THE 3288 02:22:19,297 --> 02:22:23,368 NUMBER OF CA OF EACH OF THESE 3289 02:22:23,368 --> 02:22:24,669 AROUND THE WORLD AND YOU CAN SEE 3290 02:22:24,669 --> 02:22:28,874 THE POPULATION AT RISK, WHICH 3291 02:22:28,874 --> 02:22:34,513 EXCEEDS 1 BILLION PEOPLE ALSO 3292 02:22:34,513 --> 02:22:36,081 KNOWN AS RIVER BLINDNESS, IT'S 3293 02:22:36,081 --> 02:22:40,886 THE SECOND LEADING CAUSE OF 3294 02:22:40,886 --> 02:22:42,287 INFECTIOUS BLINDNESS AROUND THE 3295 02:22:42,287 --> 02:22:44,022 WORLD. 3296 02:22:44,022 --> 02:22:45,690 LYMPHATIC -- IS COMMONLY 3297 02:22:45,690 --> 02:22:48,326 REFERRED TO AS ELEPHANTIASIS 3298 02:22:48,326 --> 02:22:50,729 BECAUSE OF THE SORT OF CLINICAL 3299 02:22:50,729 --> 02:22:54,566 DEVASTATION AS SHOWN HERE, 3300 02:22:54,566 --> 02:22:55,834 PHOTOGRAPH THAT WAS ON THE COVER 3301 02:22:55,834 --> 02:22:57,736 OF "THE NEW YORK TIMES" MAGAZINE 3302 02:22:57,736 --> 02:23:04,276 SECTION ON THE TOP AND A WHO 3303 02:23:04,276 --> 02:23:05,811 STATUE IN FRONT OF WHO 3304 02:23:05,811 --> 02:23:08,680 HEADQUARTERS IN GENEVA SHOWING A 3305 02:23:08,680 --> 02:23:10,248 YOUNG BOY LEAVING AFRICAN 3306 02:23:10,248 --> 02:23:13,952 ELDERLY MEN TO THE FIELDS 3307 02:23:13,952 --> 02:23:16,555 BECAUSE THEY'VE ALL BEEN BLINDED 3308 02:23:16,555 --> 02:23:23,662 BY ONCO -- THE MOST DEVASTATING 3309 02:23:23,662 --> 02:23:25,197 CONSEQUENCES ARE ELEPHANTIASIS 3310 02:23:25,197 --> 02:23:27,399 AND THESE ARE CLINICAL PICTURES 3311 02:23:27,399 --> 02:23:27,833 SHOWN HERE. 3312 02:23:27,833 --> 02:23:32,771 AS YOU CAN IMAGINE, THESE HAVE 3313 02:23:32,771 --> 02:23:36,041 DEVASTATING CONSEQUENCES. 3314 02:23:36,041 --> 02:23:37,008 IF YOU LOOK AROUND THE WORLD 3315 02:23:37,008 --> 02:23:39,411 WHERE THESE EXIST, THEY EXIST IN 3316 02:23:39,411 --> 02:23:41,913 LARGELY UNDERRESOURCED LOW AND 3317 02:23:41,913 --> 02:23:45,517 MIDDLE INCOME COUNTRIES, AND SO 3318 02:23:45,517 --> 02:23:46,485 ALL DIAGNOSTICS THAT ARE BEING 3319 02:23:46,485 --> 02:23:53,492 USED FOR THESE TYPICALLY HAVE 3320 02:23:53,492 --> 02:23:58,330 LITTLE LIKELIHOOD OF PROVIDING 3321 02:23:58,330 --> 02:24:02,033 COMMERCIAL VALUE TO COMPANIES 3322 02:24:02,033 --> 02:24:05,670 THAT ARE CONSIDERED -- WHO ARE 3323 02:24:05,670 --> 02:24:08,273 WILLING TO COMMIT TO 3324 02:24:08,273 --> 02:24:10,242 COMMERCIALIZING PRODUCTS OR 3325 02:24:10,242 --> 02:24:13,345 MAKING THEM AT SCALE IN A 3326 02:24:13,345 --> 02:24:14,246 MANUFACTURABLE WAY. 3327 02:24:14,246 --> 02:24:16,715 AND SO LARGELY I JUST WANT TO 3328 02:24:16,715 --> 02:24:18,583 LAY OUT THE PROBLEMS AND ROAD 3329 02:24:18,583 --> 02:24:23,722 BLOCKS IN THESE NTD DIAGNOSTICS, 3330 02:24:23,722 --> 02:24:25,056 INCLUDE THE DISEASES AND USES 3331 02:24:25,056 --> 02:24:26,258 ARE EXCLUSIVELY LIMITED TO LOW 3332 02:24:26,258 --> 02:24:29,761 AND MIDDLE INCOME COUNTRIES, AND 3333 02:24:29,761 --> 02:24:31,396 THESE DIAGNOSTICS ARE UNLIKE 3334 02:24:31,396 --> 02:24:32,297 MOST DIAGNOSTICS BECAUSE WE'RE 3335 02:24:32,297 --> 02:24:35,267 NOT LOOKING AT NECESSARILY AT 3336 02:24:35,267 --> 02:24:36,434 ONLY THE INDIVIDUAL, DO THEY 3337 02:24:36,434 --> 02:24:38,436 HAVE THE INFECTION OR DO THEY 3338 02:24:38,436 --> 02:24:38,970 NOT. 3339 02:24:38,970 --> 02:24:41,907 WE'RE OFTEN NEEDING TO ASSESS 3340 02:24:41,907 --> 02:24:44,676 ENTIRE DISTRICTS OF POPULATIONS 3341 02:24:44,676 --> 02:24:45,744 OR COMMUNITIES TO UNDERSTAND THE 3342 02:24:45,744 --> 02:24:47,212 PREVALENCE OF THESE INFECTIONS 3343 02:24:47,212 --> 02:24:51,750 AND THEN HOW TO DEAL WITH THEM. 3344 02:24:51,750 --> 02:24:53,852 AND THE ONLY TIME THAT WE USE 3345 02:24:53,852 --> 02:24:55,620 THEM AT THE INDIVIDUAL LEVEL ARE 3346 02:24:55,620 --> 02:24:57,455 IN THESE RESEARCH-RICH 3347 02:24:57,455 --> 02:24:59,224 COUNTRIES, SUCH AS THE U.S., AND 3348 02:24:59,224 --> 02:25:04,029 WE DO USE THEM HERE BECAUSE 3349 02:25:04,029 --> 02:25:10,602 THESE DO AFFECT TRAVELERS, 3350 02:25:10,602 --> 02:25:12,137 REFUGEES WHO NEED TESTING. 3351 02:25:12,137 --> 02:25:15,507 MOTOR COMMERCIAL ENT TEES ARE 3352 02:25:15,507 --> 02:25:17,809 GENERALLY UNWILLING TO 3353 02:25:17,809 --> 02:25:20,779 UNDERWRITE THE RESEARCH COST TO 3354 02:25:20,779 --> 02:25:22,847 MAKE A MANUFACTURABLE DIAGNOSTIC 3355 02:25:22,847 --> 02:25:24,149 DEVICE, AND AS SORT OF A -- 3356 02:25:24,149 --> 02:25:26,585 WE'LL JUST SORT OF STAND ON A 3357 02:25:26,585 --> 02:25:29,521 SOAP BOX A LITTLE BIT TO SAY 3358 02:25:29,521 --> 02:25:31,056 THAT UNLIKE THE PHARMACEUTICAL 3359 02:25:31,056 --> 02:25:32,924 COMPANIES SUCH AS MERCK OR GSK 3360 02:25:32,924 --> 02:25:39,798 OR PFIZER THAT HAVE LARGE 3361 02:25:39,798 --> 02:25:42,000 DONATION PROGRAMS FOR MASS DRUG 3362 02:25:42,000 --> 02:25:43,001 ADMINISTRATION CAMPAIGNS ACROSS 3363 02:25:43,001 --> 02:25:46,137 THE WORLD, LARGE DIAGNOSTIC 3364 02:25:46,137 --> 02:25:47,172 FIRMS HAVE NOT GENERALLY BEEN 3365 02:25:47,172 --> 02:25:49,741 WILLING TO OVERLOOK COMMERCIAL 3366 02:25:49,741 --> 02:25:50,108 CONSTRAINTS. 3367 02:25:50,108 --> 02:25:51,343 BUT I'M GOING TO TELL YOU A 3368 02:25:51,343 --> 02:25:53,278 STORY ABOUT HOW WE'VE OVERCOME 3369 02:25:53,278 --> 02:25:55,480 SOME OF THESE. 3370 02:25:55,480 --> 02:25:57,882 AND THE STORY GOES BACK TO 3371 02:25:57,882 --> 02:26:01,286 REALLY THE 1980s, 1991, 3372 02:26:01,286 --> 02:26:02,821 REPORTED IN SCIENCE, THE 3373 02:26:02,821 --> 02:26:07,092 IDENTIFICATION OF AN IMMUNOGENIC 3374 02:26:07,092 --> 02:26:07,726 ONCOSPECIFIC ANTIGEN THAT COULD 3375 02:26:07,726 --> 02:26:09,594 BE USED AS A SPECIFIC AND EARLY 3376 02:26:09,594 --> 02:26:12,030 MARKER OF INFECTION, AND WE 3377 02:26:12,030 --> 02:26:13,665 WROTE IN THE FINAL PARAGRAPH OF 3378 02:26:13,665 --> 02:26:15,667 THIS THAT THE POTENTIAL USES OF 3379 02:26:15,667 --> 02:26:19,404 THIS WOULD BE TO DIAGNOSE 3380 02:26:19,404 --> 02:26:20,572 INDIVIDUALS TO DO PRIMARY 3381 02:26:20,572 --> 02:26:24,876 SURVEILLANCE IN AREAS OF UNKN 3382 02:26:24,876 --> 02:26:25,977 UNKNOWN -- TO DETECT EARLY 3383 02:26:25,977 --> 02:26:31,182 INFECTIONS OR AS A MARKER OF 3384 02:26:31,182 --> 02:26:33,918 TRANSMISSION, AND ULTIMATELY TO 3385 02:26:33,918 --> 02:26:35,120 BE USED NATIONWIDE TO CERTIFY 3386 02:26:35,120 --> 02:26:36,187 THAT SOME OF THESE INFECTIONS 3387 02:26:36,187 --> 02:26:37,422 HAVE BEEN ELIMINATED. 3388 02:26:37,422 --> 02:26:38,857 WE'RE IN THE PROCESS OF -- WE'VE 3389 02:26:38,857 --> 02:26:40,292 DONE THIS ALREADY IN SEVERAL 3390 02:26:40,292 --> 02:26:43,328 COUNTRIES AROUND THE WORLD. 3391 02:26:43,328 --> 02:26:48,600 AND SO IN 1991, WE IDENTIFIED 3392 02:26:48,600 --> 02:26:52,570 THIS AND PUBLISHED THIS MARKER, 3393 02:26:52,570 --> 02:26:56,141 AND IT TOOK US 8 OR 9 YEARS TO 3394 02:26:56,141 --> 02:26:59,978 FIND ANY COMMERCIAL GROUP WHO 3395 02:26:59,978 --> 02:27:04,683 WAS WILLING TO EVEN MAKE A 3396 02:27:04,683 --> 02:27:05,684 PROTOTYPE, BUT SHOWN HERE IS A 3397 02:27:05,684 --> 02:27:09,821 COMPANY FROM AUSTRALIA AT THE 3398 02:27:09,821 --> 02:27:12,924 TIME, AMRAD ICT, AND THEY 3399 02:27:12,924 --> 02:27:14,926 DEVELOPED -- PIGGY BACKED, IN A 3400 02:27:14,926 --> 02:27:17,662 MATTER OF TWO OR THREE WEEKS, 3401 02:27:17,662 --> 02:27:18,863 FROM AN EXISTING TEST THAT THEY 3402 02:27:18,863 --> 02:27:21,533 HAD DONE, THEY PIGGY BACKED THIS 3403 02:27:21,533 --> 02:27:22,400 ANTIGEN AND CAME UP WITH 3404 02:27:22,400 --> 02:27:24,869 SOMETHING THAT WORKED 3405 02:27:24,869 --> 02:27:26,538 EXTRAORDINARILY WELL. 3406 02:27:26,538 --> 02:27:28,740 THEY PUT -- DID A PRODUCTION RUN 3407 02:27:28,740 --> 02:27:30,141 OF 20,000 AND WE DID FIELD 3408 02:27:30,141 --> 02:27:35,513 TESTING IN AFRICA AND SHOWED THE 3409 02:27:35,513 --> 02:27:36,581 SENSITIVITY WAS HIGH, 3410 02:27:36,581 --> 02:27:40,785 SPECIFICITY WAS GREATER THAN 3411 02:27:40,785 --> 02:27:41,119 98%. 3412 02:27:41,119 --> 02:27:46,124 IT PICKED UP ALL-COMERS WHO WERE 3413 02:27:46,124 --> 02:27:48,026 INFECTED, TRULY INFECTED, AND IT 3414 02:27:48,026 --> 02:27:51,730 WAS USEFUL IN ASSESSING REPREU 3415 02:27:51,730 --> 02:27:53,164 DESENSE OF INFECTION AND SUCCESS 3416 02:27:53,164 --> 02:27:54,933 OF THESE CONTROL PROGRAMS IN 3417 02:27:54,933 --> 02:27:56,267 LARGE FIELD TESTINGS ACROSS 3418 02:27:56,267 --> 02:28:01,172 AFRICA AND THE AMERICAS. 3419 02:28:01,172 --> 02:28:03,942 BUT HERE'S THE PROBLEM. 3420 02:28:03,942 --> 02:28:09,114 IN 2001, BINEX BOUGHT ANRAB AND 3421 02:28:09,114 --> 02:28:10,382 THEY MADE A COMMERCIAL DECISION 3422 02:28:10,382 --> 02:28:11,416 THAT THIS WAS NOT GOING TO BE 3423 02:28:11,416 --> 02:28:13,284 ANYTHING THAT WAS GOING TO FIT 3424 02:28:13,284 --> 02:28:18,323 INTO A COMMERCIAL -- THEIR SORT 3425 02:28:18,323 --> 02:28:20,725 OF FUTURE COMMERCIAL ROLES AND 3426 02:28:20,725 --> 02:28:22,160 THEY DISCARDED IT. 3427 02:28:22,160 --> 02:28:25,563 AND AS YOU ARE ALL WELL AWARE IN 3428 02:28:25,563 --> 02:28:27,298 THE DIAGNOSTIC WORLD AND THE 3429 02:28:27,298 --> 02:28:28,266 PHARMACEUTICAL WORLD AND 3430 02:28:28,266 --> 02:28:29,868 EVERYWHERE ELSE, THERE ARE LOTS 3431 02:28:29,868 --> 02:28:32,804 OF MERGERS AND ACQUISITIONS 3432 02:28:32,804 --> 02:28:33,805 BECAUSE I'M GOING TO GET BACK TO 3433 02:28:33,805 --> 02:28:36,941 THIS IN A SECOND, BUT OLE. 3434 02:28:36,941 --> 02:28:39,711 AR BOUGHT BINEX IN 2005, ABBOTT 3435 02:28:39,711 --> 02:28:42,113 BOUGHT ALEER IN 2017, AND THEN 3436 02:28:42,113 --> 02:28:43,548 ABBOTT BOUGHT STANDARD 3437 02:28:43,548 --> 02:28:45,617 DIAGNOSTICS IN 2021. 3438 02:28:45,617 --> 02:28:46,818 AND THIS IS GOING TO BE 3439 02:28:46,818 --> 02:28:49,554 IMPORTANT AS I GET TO SOME OF MY 3440 02:28:49,554 --> 02:28:51,422 LATER DISCUSSION. 3441 02:28:51,422 --> 02:28:53,124 SO FORTUNATELY FOR US, 10 YEARS 3442 02:28:53,124 --> 02:28:56,261 OR 11 YEARS LATER, THE BILL AND 3443 02:28:56,261 --> 02:28:58,329 MELINDA GATES FOUNDATION WAS 3444 02:28:58,329 --> 02:29:03,368 WILLING TO PARTNER WITH PATH AND 3445 02:29:03,368 --> 02:29:08,940 US TO COME UP WITH A WAY TO GET 3446 02:29:08,940 --> 02:29:11,176 TO COMMERCIALIZATION OF A VERY 3447 02:29:11,176 --> 02:29:12,610 USEFUL PRODUCT, AND SO THEY 3448 02:29:12,610 --> 02:29:16,047 PROVIDED MONEY TO PATH TO DO ALL 3449 02:29:16,047 --> 02:29:17,615 OF THE LANDSCAPING AND TO US AND 3450 02:29:17,615 --> 02:29:21,352 THEM TO DO ALL OF THE RESEARCH 3451 02:29:21,352 --> 02:29:26,624 AND DEVELOPMENT AND VALIDATION 3452 02:29:26,624 --> 02:29:27,926 TO ULTIMATELY BE ABLE TO 3453 02:29:27,926 --> 02:29:31,496 TRANSFER THIS INITIAL LAB BASED 3454 02:29:31,496 --> 02:29:35,133 TEST AND FORMALLY COMMERCIALIZED 3455 02:29:35,133 --> 02:29:36,601 TEST TO A KIND OF LONG-STANDING 3456 02:29:36,601 --> 02:29:37,435 COMMERCIAL PARTNER, AND THEY 3457 02:29:37,435 --> 02:29:40,705 WERE ABLE TO NEGOTIATE 3458 02:29:40,705 --> 02:29:41,506 COMMERCIAL TERMS SUCH THAT IT 3459 02:29:41,506 --> 02:29:43,808 COULD BE SOLD AT COST, PLUS A 3460 02:29:43,808 --> 02:29:47,846 FEW CENTS, TO WHO OR MINISTRIES 3461 02:29:47,846 --> 02:29:50,148 OF HEALTH OR NGOs AND THE WAY 3462 02:29:50,148 --> 02:29:53,117 THEY WERE ABLE TO SELL THIS WAS 3463 02:29:53,117 --> 02:29:55,320 TO GUARANTEE PROCUREMENT ON A 3464 02:29:55,320 --> 02:29:56,521 YEARLY BASIS, A CERTAIN NUMBER 3465 02:29:56,521 --> 02:29:59,390 OF TESTS PER YEAR, SO EVEN IF A 3466 02:29:59,390 --> 02:30:00,625 COMPANY IS ONLY MAKING A FEW 3467 02:30:00,625 --> 02:30:03,228 CENTS ON THIS, IF YOU CAN SELL A 3468 02:30:03,228 --> 02:30:04,796 MILLION OF THEM, THEN AT LEAST 3469 02:30:04,796 --> 02:30:07,298 YOU'RE GOING TO COVER YOUR COSTS 3470 02:30:07,298 --> 02:30:08,733 ON SOME OF THE OTHER THINGS. 3471 02:30:08,733 --> 02:30:09,801 AND THERE WAS AN AGREEMENT TO 3472 02:30:09,801 --> 02:30:11,836 ALLOW THE COMPANIES TO SELL 3473 02:30:11,836 --> 02:30:13,271 COMMERCIALLY THE PRODUCTS AT 3474 02:30:13,271 --> 02:30:17,508 MARKET PRICES IF NEEDED IN MORE 3475 02:30:17,508 --> 02:30:21,579 RESOURCED AREAS. 3476 02:30:21,579 --> 02:30:25,950 WE WERE REALLY LUCKY THAT THIS 3477 02:30:25,950 --> 02:30:30,221 PRIVATE PARTNER, PRIVATE PUBLIC 3478 02:30:30,221 --> 02:30:34,826 PARTNERSHIP WAS SUCCESSFUL AND 3479 02:30:34,826 --> 02:30:38,897 WE WERE ABLE TO MOVE THIS INTO 3480 02:30:38,897 --> 02:30:44,035 COMMERCIAL MANUFACTURING SPACE 3481 02:30:44,035 --> 02:30:45,770 WITH STANDARD DIAGNOSTICS IN 3482 02:30:45,770 --> 02:30:50,041 KOREA THAT HAD -- THIS IS JUST A 3483 02:30:50,041 --> 02:30:51,609 PICTURE OF THIS, AND THE POINT 3484 02:30:51,609 --> 02:30:55,346 ABOUT THIS WAS THAT IT WAS AN 3485 02:30:55,346 --> 02:30:57,882 RDT WITH A VERY LONG READ WINDOW 3486 02:30:57,882 --> 02:30:58,917 AND END POINT STABILITY. 3487 02:30:58,917 --> 02:30:59,717 YOU CAN IMAGINE SINCE THESE 3488 02:30:59,717 --> 02:31:03,421 TESTS ARE DEPLOYED IN RURAL AR 3489 02:31:03,421 --> 02:31:06,190 AREAS OF AFRICA WHERE THERE'S NO 3490 02:31:06,190 --> 02:31:11,529 ELECTRICITY THAT HAVING A TEST 3491 02:31:11,529 --> 02:31:13,197 STABLE AT ROOM TEMPERATURE OR IN 3492 02:31:13,197 --> 02:31:14,499 HIGH TEMPERATURE FOR LONG SHELF 3493 02:31:14,499 --> 02:31:19,103 LIFE AND THAT THE RESULTS COULD 3494 02:31:19,103 --> 02:31:20,939 BE STABLE -- LARGELY 3495 02:31:20,939 --> 02:31:25,443 INDEFINITELY, WAS AN IMPORTANT 3496 02:31:25,443 --> 02:31:29,614 PART AND ULTIMATELY IN 2015 WAS 3497 02:31:29,614 --> 02:31:32,850 LAUNCHED AS -- IGG 4 AND TO 3498 02:31:32,850 --> 02:31:33,985 DATE, MILLIONS HAVE BEEN 3499 02:31:33,985 --> 02:31:39,057 UTILIZED ACROSS THE WORLD. 3500 02:31:39,057 --> 02:31:40,725 AROUND THE SAME TIME, WE HAD 3501 02:31:40,725 --> 02:31:42,627 DISCOVERED AND PUBLISHED IN 2012 3502 02:31:42,627 --> 02:31:44,629 A SECOND ANTIGEN FOR THIS 3503 02:31:44,629 --> 02:31:46,264 LYMPHATIC FI FILARIASIS THAT HAD 3504 02:31:46,264 --> 02:31:47,532 THE SAME KINDS OF PROPERTIES, 3505 02:31:47,532 --> 02:31:49,901 HIGH SENSITIVITY, HIGH 3506 02:31:49,901 --> 02:31:54,238 SPECIFICITY AND BECAUSE A LOT OF 3507 02:31:54,238 --> 02:31:57,342 THESE INFECTIONS EXIST TOGETHER 3508 02:31:57,342 --> 02:32:00,278 IN THE SAME AREA OF COENDEMIC, 3509 02:32:00,278 --> 02:32:05,883 WE WERE ABLE TO COMMERCIALIZE 3510 02:32:05,883 --> 02:32:08,820 BOTH AND -- WHICH WAS 3511 02:32:08,820 --> 02:32:09,721 RESEARCH-ONLY AS WELL AS TO ADD 3512 02:32:09,721 --> 02:32:12,957 THIS ANTIGEN TO THE SD BIOLINE 3513 02:32:12,957 --> 02:32:15,493 PORTFOLIO, AND NOW WE HAD A 3514 02:32:15,493 --> 02:32:17,395 BIPLEX TEST COMMERCIALLY 3515 02:32:17,395 --> 02:32:20,498 AVAILABLE, SOLD AT COST, THAT 3516 02:32:20,498 --> 02:32:30,875 COULD DETECT BOTH ONC 3517 02:32:31,476 --> 02:32:32,343 ONCHOCERCIASIS -- SPECIFIC 3518 02:32:32,343 --> 02:32:33,244 ANTIGEN. 3519 02:32:33,244 --> 02:32:37,882 SO I'M GOING TO END UP SHORTLY 3520 02:32:37,882 --> 02:32:39,684 ON THE LESSONS LEARNED AND 3521 02:32:39,684 --> 02:32:40,618 CAUTIONS, I'D LIKE TO SORT OF 3522 02:32:40,618 --> 02:32:42,820 PUT OUT THERE, DIAGNOSTICS FOR 3523 02:32:42,820 --> 02:32:44,088 PUBLIC HEALTH DECISION-MAKING 3524 02:32:44,088 --> 02:32:48,092 WHICH IS WHAT MOST OF THESE ARE 3525 02:32:48,092 --> 02:32:49,394 AND GIVES YOU THE VERY LARGE 3526 02:32:49,394 --> 02:32:52,597 SORT OF POPULATION -- TARGET 3527 02:32:52,597 --> 02:32:54,232 POPULATION TO WHICH THESE TESTS 3528 02:32:54,232 --> 02:32:56,768 ARE GOING TO BE USED, ARE 3529 02:32:56,768 --> 02:32:59,804 DIFFICULT SELL TO MOST COMPAN 3530 02:32:59,804 --> 02:33:00,938 COMPANIES. 3531 02:33:00,938 --> 02:33:03,341 AS YOU CAN SEE WE WENT FROM 1989 3532 02:33:03,341 --> 02:33:09,614 ESSENTIALLY TO 2015 BEFORE A 3533 02:33:09,614 --> 02:33:10,915 VERY USABLE TEST WAS ACTUALLY 3534 02:33:10,915 --> 02:33:14,052 ABLE TO BE PUT OUT THERE IN 3535 02:33:14,052 --> 02:33:16,054 LARGE SCALE, SO MAKING THE POINT 3536 02:33:16,054 --> 02:33:20,825 THAT IT DOES REQUIRE PATIENTS IF 3537 02:33:20,825 --> 02:33:22,360 YOU'RE IN THIS SPACE. 3538 02:33:22,360 --> 02:33:23,594 THE OTHER THING I THINK IS 3539 02:33:23,594 --> 02:33:24,495 REALLY IMPORTANT TO MAKE SURE 3540 02:33:24,495 --> 02:33:28,800 THAT THE USE CASES AND THE 3541 02:33:28,800 --> 02:33:31,636 TARGET PROFILES ARE DEFINED AND 3542 02:33:31,636 --> 02:33:33,738 CAN BE MET IN ADVANCE OF 3543 02:33:33,738 --> 02:33:36,007 COMMERCIALIZATION SO THAT WHEN 3544 02:33:36,007 --> 02:33:37,675 THERE IS A COMMERCIALIZED 3545 02:33:37,675 --> 02:33:38,976 PRODUCT, YOU CAN ACTUALLY GO OUT 3546 02:33:38,976 --> 02:33:42,513 THERE AND GET A BUY-IN FROM 3547 02:33:42,513 --> 02:33:45,683 PEOPLE WHO NEED IT AND I THINK 3548 02:33:45,683 --> 02:33:48,419 THIS DOESN'T COME UP OFTEN, 3549 02:33:48,419 --> 02:33:49,620 PARTICULARLY AS WE'RE TALKING 3550 02:33:49,620 --> 02:33:52,957 TODAY, BUT TO ENSURE SUSTA 3551 02:33:52,957 --> 02:33:54,225 SUSTAINABILITY GIVEN MERGERS AND 3552 02:33:54,225 --> 02:33:54,559 ACQUISITIONS. 3553 02:33:54,559 --> 02:33:56,861 SO I MENTIONED IN THAT EARLIER 3554 02:33:56,861 --> 02:33:59,697 SLIDE THAT SD WAS PURCHASED BY 3555 02:33:59,697 --> 02:34:03,101 ABBOTT, AND WE DON'T HAVE ANY 3556 02:34:03,101 --> 02:34:05,837 GUARANTEE THAT -- IN ANOTHER 3557 02:34:05,837 --> 02:34:09,574 YEAR OR SO, WHEN OUR INITIAL 3558 02:34:09,574 --> 02:34:12,910 SORT OF AGREEMENT ENDS, WHETHER 3559 02:34:12,910 --> 02:34:13,911 A VERY LARGE COMPANY LIKE THIS 3560 02:34:13,911 --> 02:34:22,553 IS GOING TO BE WILLING TO TAKE 3561 02:34:22,553 --> 02:34:23,955 TO DO SOMETHING THAT IS OF GREAT 3562 02:34:23,955 --> 02:34:26,124 BENEFIT TO THE WORLD BUT NOT 3563 02:34:26,124 --> 02:34:29,360 NECESSARILY TO THE COMPANY'S 3564 02:34:29,360 --> 02:34:32,830 BOTTOM LINE. 3565 02:34:32,830 --> 02:34:34,499 AS I'M GOING TO MAKE IN THE NEXT 3566 02:34:34,499 --> 02:34:35,299 SLIDE, DON'T IGNORE THESE 3567 02:34:35,299 --> 02:34:38,136 SMALLER COMPANIES BECAUSE I 3568 02:34:38,136 --> 02:34:39,570 THINK I'M GOING TO SHOW YOU SOME 3569 02:34:39,570 --> 02:34:40,571 EXAMPLES OF WHERE THAT HAS MADE 3570 02:34:40,571 --> 02:34:47,111 A BIG DIFFERENCE. 3571 02:34:47,111 --> 02:34:49,447 SO THINGS IN MY OWN GROUP I'M 3572 02:34:49,447 --> 02:34:50,381 INVOLVED IN AND SOME OF WHICH 3573 02:34:50,381 --> 02:34:54,552 HAVE GONE QUITE A LONG WAY TO 3574 02:34:54,552 --> 02:35:00,358 COMMERCIALIZATION, WE HAVE 3575 02:35:00,358 --> 02:35:03,327 ANOTHER PARASITE WHERE 3576 02:35:03,327 --> 02:35:04,929 COMMERCIALIZED PRODUCT HAS BEEN 3577 02:35:04,929 --> 02:35:06,364 DEVELOPED, THERE'S NEW SECOND 3578 02:35:06,364 --> 02:35:08,833 GENERATIONS OF THESE RUTs THAT 3579 02:35:08,833 --> 02:35:12,203 I'VE JUST DISCUSSED, AND THEN 3580 02:35:12,203 --> 02:35:14,071 LISTED BELOW ARE SOME OTHER 3581 02:35:14,071 --> 02:35:16,607 INTERACTIONS THAT ARE COMING TO 3582 02:35:16,607 --> 02:35:22,647 THE MARKETPLACE SOON, AND I WILL 3583 02:35:22,647 --> 02:35:26,150 MENTION THAT THOUGH I TALKED 3584 02:35:26,150 --> 02:35:28,519 ABOUT ANTIBODY DETECTION HERE 3585 02:35:28,519 --> 02:35:31,689 TODAY, WE ARE WORKING ON POINT 3586 02:35:31,689 --> 02:35:33,257 OF CARE NUCLEIC ACID TESTS AND 3587 02:35:33,257 --> 02:35:39,063 HAVE MULTIPLE PARTNERS FOR POINT 3588 02:35:39,063 --> 02:35:43,801 OF CARE HIGHLY SENSITIVE, HIGHLY 3589 02:35:43,801 --> 02:35:46,404 SPECIFIC DNA OR OTHER -- OR 3590 02:35:46,404 --> 02:35:49,640 URINE OR CSF FOR A VARIETY OF 3591 02:35:49,640 --> 02:35:51,609 DIFFERENT SYNDROMES AS WELL AS 3592 02:35:51,609 --> 02:35:56,080 OTHER PARASITIC INFECTIONS. 3593 02:35:56,080 --> 02:35:57,381 WITH THAT, I'LL STOP AND JUST 3594 02:35:57,381 --> 02:35:58,516 NOTE THAT A NUMBER OF -- 3595 02:35:58,516 --> 02:35:59,517 OBVIOUSLY A NUMBER OF PEOPLE 3596 02:35:59,517 --> 02:36:00,851 HAVE BEEN INVOLVED IN MANY OF 3597 02:36:00,851 --> 02:36:05,656 THESE DIFFERENT PROJECTS PROJECM 3598 02:36:05,656 --> 02:36:07,425 LISTING HERE MY MAJOR 3599 02:36:07,425 --> 02:36:08,025 COLLABORATORS ON THE PROJECT. 3600 02:36:08,025 --> 02:36:15,666 WITH THAT, I'LL STOP. 3601 02:36:15,666 --> 02:36:17,268 >> THANK YOU, TOM. 3602 02:36:17,268 --> 02:36:18,703 WE HAVE A QUESTION FOR YOU AS 3603 02:36:18,703 --> 02:36:20,905 WELL BUT WE'LL HOLD IT UNTIL THE 3604 02:36:20,905 --> 02:36:21,305 END. 3605 02:36:21,305 --> 02:36:25,443 SO ONE THING THAT THIS PANEL, 3606 02:36:25,443 --> 02:36:28,412 AMONG MANY THINGS, THAT IS SO 3607 02:36:28,412 --> 02:36:29,647 WONDERFULLY DEMONSTRATES IS THE 3608 02:36:29,647 --> 02:36:32,516 DIFFERENT SIZES AND STAGES OF 3609 02:36:32,516 --> 02:36:34,185 THE COMPANIES THAT WE WORK WITH, 3610 02:36:34,185 --> 02:36:36,587 YOU HAVE ONE THAT'S GLOBAL AND 3611 02:36:36,587 --> 02:36:38,422 WORLDWIDE LIKE QIAGEN, YOU HAVE 3612 02:36:38,422 --> 02:36:41,559 ONE THAT HAS OBTAINED A HUGE 3613 02:36:41,559 --> 02:36:43,661 AMOUNT OF SUCCESS IN ABOUT A 3614 02:36:43,661 --> 02:36:46,297 DECADE AND REALLY BECOME A A 3615 02:36:46,297 --> 02:36:47,598 REGIONAL PLAYER, AND THAT'S 3616 02:36:47,598 --> 02:36:49,233 2020, AND NOW WE HAVE SOMETHING 3617 02:36:49,233 --> 02:36:54,405 ON THE EARLIER SIDE AND THAT IS 3618 02:36:54,405 --> 02:36:57,909 RACHEL ZAYAS, FOUNDER AND CEO OF 3619 02:36:57,909 --> 02:36:58,643 AGED DIAGNOSTICS. 3620 02:36:58,643 --> 02:36:59,477 >> THANK YOU, MICHAEL. 3621 02:36:59,477 --> 02:37:00,211 APPRECIATE IT. 3622 02:37:00,211 --> 02:37:01,979 ALL RIGHT. 3623 02:37:01,979 --> 02:37:02,747 HELLO, GOOD AFTERNOON. 3624 02:37:02,747 --> 02:37:05,816 MY NAME IS RACHEL ZAYAS, FOUNDER 3625 02:37:05,816 --> 02:37:08,486 AND CEO OF AGED DIAGNOSTICS. 3626 02:37:08,486 --> 02:37:11,589 WHEN I WAS WORKING AT MIT IN 3627 02:37:11,589 --> 02:37:13,991 CANCER RESEARCH AT THE KOCH 3628 02:37:13,991 --> 02:37:15,393 INSTITUTE, I REALIZED THE TOOLS 3629 02:37:15,393 --> 02:37:16,627 WE WERE USING WERE NOT BEING 3630 02:37:16,627 --> 02:37:17,828 WELL TRANSLATED INTO THE CLINIC. 3631 02:37:17,828 --> 02:37:20,164 I SAW AN OPPORTUNITY TO IMPROVE 3632 02:37:20,164 --> 02:37:21,465 THE LIVES OF PATIENTS. 3633 02:37:21,465 --> 02:37:22,667 OUR TEAM IS WORKING TOGETHER TO 3634 02:37:22,667 --> 02:37:25,636 CREATE THE FIRST ACCURATE BLOOD 3635 02:37:25,636 --> 02:37:31,642 TEST FOR FATTY LIVER DISEASE. 3636 02:37:31,642 --> 02:37:33,077 EARLY DETECTION, INTERVENTION 3637 02:37:33,077 --> 02:37:34,445 AND IMPROVED OUTCOMES FOR 3638 02:37:34,445 --> 02:37:38,683 PATIENTS AND THEIR FAMILIES. 3639 02:37:38,683 --> 02:37:39,884 DID YOU KNOW ONE IN THREE 3640 02:37:39,884 --> 02:37:41,852 AMERICANS OR 100 MILLION PEOPLE 3641 02:37:41,852 --> 02:37:43,120 IN THE UNITED STATES HAVE FATTY 3642 02:37:43,120 --> 02:37:43,721 LIVER DISEASE? 3643 02:37:43,721 --> 02:37:44,889 THIS DISEASE IS NOT ASSOCIATED 3644 02:37:44,889 --> 02:37:46,624 WITH ALCOHOL CONSUMPTION, BUT 3645 02:37:46,624 --> 02:37:48,592 RATHER DIABETES, OBESITY AND 3646 02:37:48,592 --> 02:37:49,260 METABOLIC SYNDROME. 3647 02:37:49,260 --> 02:37:55,933 IT IS CALLED NON-ALCOHOLIC STATA 3648 02:37:55,933 --> 02:38:00,104 HEPATITIS OR NASH. 3649 02:38:00,104 --> 02:38:02,273 AT LATER STAGES IT'S NO LONGER 3650 02:38:02,273 --> 02:38:03,240 TREATABLE OR REVERSIBLE. 3651 02:38:03,240 --> 02:38:05,309 THERE ARE VERY FEW EFFECTIVE 3652 02:38:05,309 --> 02:38:06,410 NONINVASIVE DIAGNOSTIC TOOLS 3653 02:38:06,410 --> 02:38:10,114 THAT CAN DIFFERENTIATE THE 3654 02:38:10,114 --> 02:38:11,582 BENIGN OR ADVANCED FORM. 3655 02:38:11,582 --> 02:38:12,616 A PICTURE IS WORTH A THOUSAND 3656 02:38:12,616 --> 02:38:15,386 WORDS SO I SHOW THIS MAP TO 3657 02:38:15,386 --> 02:38:16,854 PAINT THE GLOBAL INSTANCE OF 3658 02:38:16,854 --> 02:38:18,723 FATTY LIVER DISEASE. 3659 02:38:18,723 --> 02:38:20,024 UNITED STATES IS LEADING THIS 3660 02:38:20,024 --> 02:38:21,359 EPIDEMIC WITH MORE THAN 33% OF 3661 02:38:21,359 --> 02:38:23,661 THE U.S. POPULATION BEING HIGH 3662 02:38:23,661 --> 02:38:26,163 RISK, THE EUROPEAN UNION, 3663 02:38:26,163 --> 02:38:28,799 SOUTHEAST ASIA AND AUSTRALIA ARE 3664 02:38:28,799 --> 02:38:33,104 FOLLOWING CLOSE BEHIND. 3665 02:38:33,104 --> 02:38:34,538 SO THERE ARE TWO TYPES OF FATTY 3666 02:38:34,538 --> 02:38:35,606 LIVER DISEASE. 3667 02:38:35,606 --> 02:38:38,376 FIRST THERE'S A BENIGN FORM OF 3668 02:38:38,376 --> 02:38:39,777 LIVER DISEASE OF WHICH 3669 02:38:39,777 --> 02:38:40,878 80 MILLION PATIENTS IN THE 3670 02:38:40,878 --> 02:38:42,446 UNITED STATES HAVE THIS BENIGN 3671 02:38:42,446 --> 02:38:43,014 FORM. 3672 02:38:43,014 --> 02:38:46,050 THEN THERE'S NON-ALCOHOLIC, 3673 02:38:46,050 --> 02:38:46,751 NASH. 3674 02:38:46,751 --> 02:38:47,651 20 MILLION PATIENTS IN THE 3675 02:38:47,651 --> 02:38:50,020 UNITED STATES HAVE NASH. 3676 02:38:50,020 --> 02:38:51,355 THE CHALLENGE FOR PHYSICIANS IS 3677 02:38:51,355 --> 02:38:53,457 THAT THERE ARE ZERO TOOLS THAT 3678 02:38:53,457 --> 02:38:54,759 CAN DIFFERENTIATE THE BENIGN 3679 02:38:54,759 --> 02:38:56,060 FROM ADVANCED FORM OF FATTY 3680 02:38:56,060 --> 02:38:58,062 LIVER DISEASE. 3681 02:38:58,062 --> 02:38:59,497 IMAGING TOOLS ARE INACCURATE. 3682 02:38:59,497 --> 02:39:02,867 IF THERE IS SIGNIFICANT FAT OR 3683 02:39:02,867 --> 02:39:04,668 FLUID BETWEEN THE CHEST WALL AND 3684 02:39:04,668 --> 02:39:05,970 THE LIVER THESE TOOLS HAVE BEEN 3685 02:39:05,970 --> 02:39:07,338 KNOWN TO HAVE FAILED RESULTS IN 3686 02:39:07,338 --> 02:39:09,907 UP TO 60% OF PATIENTS. 3687 02:39:09,907 --> 02:39:11,442 THE SOLE DIAGNOSTIC TEST IS A 3688 02:39:11,442 --> 02:39:12,476 LIVER BIOPSY. 3689 02:39:12,476 --> 02:39:15,346 THESE ARE EXPENSIVE, INVASIVE, 3690 02:39:15,346 --> 02:39:16,714 PRO TO -- AND BLEEDING, 3691 02:39:16,714 --> 02:39:18,115 THEREFORE, THEY CANNOT SERVE THE 3692 02:39:18,115 --> 02:39:19,483 POPULATION AT LARGE. 3693 02:39:19,483 --> 02:39:21,185 AT AGED, WE'RE DEVELOPING THE 3694 02:39:21,185 --> 02:39:22,353 FIRST ACCURATE BLOOD TEST FOR 3695 02:39:22,353 --> 02:39:25,089 NASH AND A SECOND TOOL THAT CAN 3696 02:39:25,089 --> 02:39:27,291 STAGE LIVER FIBROSIS. 3697 02:39:27,291 --> 02:39:29,627 OUR TOOLS WILL HELP 3698 02:39:29,627 --> 02:39:30,561 HEPATOLOGISTS IMPROVE PATIENT 3699 02:39:30,561 --> 02:39:31,796 OUTCOMES, REDUCE THE BURDEN ON 3700 02:39:31,796 --> 02:39:33,364 HEALTH INSURERS AND AID IN EARLY 3701 02:39:33,364 --> 02:39:36,500 DETECTION AND INTERVENTION. 3702 02:39:36,500 --> 02:39:38,769 HERE'S HOW OUR TECHNOLOGY WORKS. 3703 02:39:38,769 --> 02:39:39,637 WE TAKE A PATIENT BLOOD SAMPLE 3704 02:39:39,637 --> 02:39:41,472 AND WE ISOLATE VERY SPECIFIC 3705 02:39:41,472 --> 02:39:43,574 BIOMARCS ASSOCIATED WITH THE 3706 02:39:43,574 --> 02:39:44,442 EPIGENOME, THEN WE TREAT THE 3707 02:39:44,442 --> 02:39:46,010 SAMPLE WITH THE SET OF 3708 02:39:46,010 --> 02:39:47,645 NASH-SPECIFIC PROBES AND A SET 3709 02:39:47,645 --> 02:39:49,713 OF LIVER DAMAGE PROBES. 3710 02:39:49,713 --> 02:39:51,182 WE APPLY TARGETED NEXT 3711 02:39:51,182 --> 02:39:52,149 GENERATION SEQUENCING ASSESSMENT 3712 02:39:52,149 --> 02:39:53,884 TO QUANTIFY THE CONCENTRATION OF 3713 02:39:53,884 --> 02:39:59,290 THESE BIOMARKERS IN CIRCULATION. 3714 02:39:59,290 --> 02:40:00,591 WE CAN STATE WITH HIGH CLINICAL 3715 02:40:00,591 --> 02:40:02,560 ACCURACY IF THE PERSON HAS NASH 3716 02:40:02,560 --> 02:40:04,628 AND WHAT STATE OF LIVER FIBROSIS 3717 02:40:04,628 --> 02:40:04,895 THEY HAVE. 3718 02:40:04,895 --> 02:40:06,564 THERE ARE THREE CORE ASPECTS TO 3719 02:40:06,564 --> 02:40:09,166 OUR TECHNOLOGY. 3720 02:40:09,166 --> 02:40:10,534 FIRST AT FOREMOST WE HAVE THE 3721 02:40:10,534 --> 02:40:13,137 FIRST TOOL THAT CAN ACCURATELY 3722 02:40:13,137 --> 02:40:14,138 DIFFERENTIATE SIMPLE STAY PTOSIS 3723 02:40:14,138 --> 02:40:16,307 FROM NASH FROM PERIPHERAL BLOOD. 3724 02:40:16,307 --> 02:40:17,641 SECOND AND OF EQUAL IMPORTANCE, 3725 02:40:17,641 --> 02:40:19,877 WE CAN STAGE LIVER FIBROSIS. 3726 02:40:19,877 --> 02:40:22,246 THERE ARE FOUR STAGES OF LIVER 3727 02:40:22,246 --> 02:40:23,481 FIBROSIS AND AFTER STAGE TWO, 3728 02:40:23,481 --> 02:40:28,519 THIS INCREASES BOTH HEPATIC AND 3729 02:40:28,519 --> 02:40:29,186 CARDIOVASCULAR MANIFESTATIONS BY 3730 02:40:29,186 --> 02:40:31,822 UP TO 80% SO IT'S CLINICALLY 3731 02:40:31,822 --> 02:40:33,824 RELEVANT TO DIAGNOSE NASH AND 3732 02:40:33,824 --> 02:40:34,758 STAGED FIBROSIS IN THE SAME 3733 02:40:34,758 --> 02:40:35,292 PATIENT AT THE SAME TIME. 3734 02:40:35,292 --> 02:40:36,760 LAST BUT NOT LEAST, WE CAN 3735 02:40:36,760 --> 02:40:38,295 EXCLUDE OTHER FORMS OF CHRONIC 3736 02:40:38,295 --> 02:40:39,630 LIVER DISEASE BY TARGETING 3737 02:40:39,630 --> 02:40:40,631 REGIONS THAT ARE ONLY FOUND IN 3738 02:40:40,631 --> 02:40:41,298 NASH AND ONLY FOUND IN THE 3739 02:40:41,298 --> 02:40:44,268 LIVER. 3740 02:40:44,268 --> 02:40:45,336 THE MARKET OPPORTUNITY IS VAST 3741 02:40:45,336 --> 02:40:46,971 AND GROWING. 3742 02:40:46,971 --> 02:40:49,106 GLOBALLY THERE ARE MORE THAN 3743 02:40:49,106 --> 02:40:50,207 2 BILLION PATIENTS CONSIDERED 3744 02:40:50,207 --> 02:40:54,278 HIGH RISK AND REQUIRE ROUTINE 3745 02:40:54,278 --> 02:40:56,547 LIVER SCREENING. 3746 02:40:56,547 --> 02:40:59,316 -- SPEND MORE THAN $100 BILLION 3747 02:40:59,316 --> 02:41:00,284 ON DIRECT MANAGEMENT FOR THIS 3748 02:41:00,284 --> 02:41:04,755 SPECIFIC TYPE OF LIVER DISEASE. 3749 02:41:04,755 --> 02:41:06,991 WHICH EQUATES TO MORE THAN A 3750 02:41:06,991 --> 02:41:09,226 $27 BILLION MARKET OPPORTUNITY. 3751 02:41:09,226 --> 02:41:11,662 WE HAVE MULTIPLE PATENTS PENDING 3752 02:41:11,662 --> 02:41:12,830 BOTH ON THE BIOMARKERS AS WELL 3753 02:41:12,830 --> 02:41:14,832 AS THE METHODS TO ASSESS THESE 3754 02:41:14,832 --> 02:41:15,733 BIOMARKERS SYNTHETICALLY IN 3755 02:41:15,733 --> 02:41:16,901 CIRCULATION. 3756 02:41:16,901 --> 02:41:20,070 OUR COMPETITIVE ADVANTAGE IS 3757 02:41:20,070 --> 02:41:22,339 THAT WE -- FIRST ACCURATE BLOOD 3758 02:41:22,339 --> 02:41:23,207 TEST FOR NASH. 3759 02:41:23,207 --> 02:41:25,075 WE'D BE LESS EXPENSIVE THAN THE 3760 02:41:25,075 --> 02:41:27,311 GOLD STANDARD WHICH ARE LIVER 3761 02:41:27,311 --> 02:41:29,413 BIOPSIES AS WELL AS MOST 3762 02:41:29,413 --> 02:41:31,181 EXPENSIVE IMAGING MODALITIES. 3763 02:41:31,181 --> 02:41:32,716 WE EXPECT TO BE THE MOST 3764 02:41:32,716 --> 02:41:33,951 ACCURATE TOOL FOR DECADES TO 3765 02:41:33,951 --> 02:41:36,921 COME BY TARGETING HIGHLY 3766 02:41:36,921 --> 02:41:38,022 INNOVATIVE GENETIC REGIONS. 3767 02:41:38,022 --> 02:41:39,423 SO WE'VE HAD EXCITING TRACTION 3768 02:41:39,423 --> 02:41:40,024 TO DATE. 3769 02:41:40,024 --> 02:41:42,793 WE HAD RECEIVED A GRANT FROM THE 3770 02:41:42,793 --> 02:41:44,061 NATIONAL SCIENCE FOUNDATION IN 3771 02:41:44,061 --> 02:41:45,696 LATE 2018 TO CONDUCT CUSTOMER 3772 02:41:45,696 --> 02:41:48,165 DISCOVERY TO VALIDATE PRODUCT 3773 02:41:48,165 --> 02:41:49,133 MARKET FIT. 3774 02:41:49,133 --> 02:41:50,234 ONCE AGAIN WE HAVE MULTIPLE 3775 02:41:50,234 --> 02:41:50,701 PATENTS PENDING. 3776 02:41:50,701 --> 02:41:52,336 IN SOME OF OUR EARLY YEARS OF 3777 02:41:52,336 --> 02:41:55,306 RESEARCH AND DEVELOPMENT, WE 3778 02:41:55,306 --> 02:41:56,507 UTILIZED OPEN SOURCE DATASETS 3779 02:41:56,507 --> 02:41:58,709 FROM NIH AND THE CANCER GENOMICS 3780 02:41:58,709 --> 02:42:00,578 CLOUD TO BE ABLE TO DETERMINE IF 3781 02:42:00,578 --> 02:42:04,315 OUR BIOMARKERS WERE EFFICACIOUS 3782 02:42:04,315 --> 02:42:05,449 EVEN DIRECTLY ON THE LIVER. 3783 02:42:05,449 --> 02:42:06,984 WE'VE BEEN FUNDED BY 3784 02:42:06,984 --> 02:42:07,418 HEALTHWORKS. 3785 02:42:07,418 --> 02:42:09,853 THIS IS THE INVESTMENT ARM OF 3786 02:42:09,853 --> 02:42:10,387 CAREFIRST BLUE CROSS/BLUE 3787 02:42:10,387 --> 02:42:10,821 SHIELD. 3788 02:42:10,821 --> 02:42:14,058 WE PRESENTED WORK AT THE ANNUAL 3789 02:42:14,058 --> 02:42:15,559 LIVER DISEASE CONFERENCE AND 3790 02:42:15,559 --> 02:42:16,760 PUBLISHED WORK IN ABSTRACT FORM 3791 02:42:16,760 --> 02:42:17,661 IN HEPATOLOGY. 3792 02:42:17,661 --> 02:42:19,630 IN 2021, WE RECEIVED OUR FIRST 3793 02:42:19,630 --> 02:42:23,901 FINANCING ROUND, AND THIS 3794 02:42:23,901 --> 02:42:25,669 ALLOWED US TO CONDUCT A PILOT 3795 02:42:25,669 --> 02:42:29,740 STUDY IN PERIPHERAL BLOOD. 3796 02:42:29,740 --> 02:42:31,275 SO TO DATE, WE'VE CONDUCTED 3797 02:42:31,275 --> 02:42:33,043 SEVERAL PILOT STUDIES AND 3798 02:42:33,043 --> 02:42:34,678 IDENTIFIED A SET OF BIOMARKERS 3799 02:42:34,678 --> 02:42:37,248 AND HAVE BETWEEN 90 AND 90% 3800 02:42:37,248 --> 02:42:37,781 EFFICACY, DIFFERENTIATING 3801 02:42:37,781 --> 02:42:39,783 BETWEEN THE BENIGN AND ADVANCED 3802 02:42:39,783 --> 02:42:40,985 FORM OF FATTY LIVER DISEASE. 3803 02:42:40,985 --> 02:42:42,987 WE'VE RECENTLY MOVED INTO TEST 3804 02:42:42,987 --> 02:42:44,488 METHOD VERIFICATION, WHERE WE'RE 3805 02:42:44,488 --> 02:42:46,390 EXPANDING THE SAMPLE SIZE TO 500 3806 02:42:46,390 --> 02:42:47,791 PATIENT SAMPLES. 3807 02:42:47,791 --> 02:42:48,892 WE'VE RECENTLY PARTNERED WITH 3808 02:42:48,892 --> 02:42:50,561 THE HENRY JACKSON FOUNDATION. 3809 02:42:50,561 --> 02:42:52,329 THIS IS A CONGRESSIONALLY 3810 02:42:52,329 --> 02:42:53,764 MANDATED NON-PROFIT FOCUSED ON 3811 02:42:53,764 --> 02:42:55,866 THE ADVANCEMENT OF U.S. MILITARY 3812 02:42:55,866 --> 02:42:56,467 MEDICINE. 3813 02:42:56,467 --> 02:42:58,335 OUR HEADQUARTERS ARE SITUATED 3814 02:42:58,335 --> 02:42:59,937 OUT OF HJF AND THIS HAS HELPED 3815 02:42:59,937 --> 02:43:02,673 US TO UTILIZE RESOURCES WITHIN 3816 02:43:02,673 --> 02:43:03,007 DOD. 3817 02:43:03,007 --> 02:43:06,844 WE HAVE MULTIPLE CRADAs AND 3818 02:43:06,844 --> 02:43:07,945 MATERIAL TRANSFER AGREEMENTS 3819 02:43:07,945 --> 02:43:09,179 WITH WALTER REED MILITARY 3820 02:43:09,179 --> 02:43:10,748 CENTER, INCLUDING THE 3821 02:43:10,748 --> 02:43:11,382 GASTROENTEROLOGY DEPARTMENT AS 3822 02:43:11,382 --> 02:43:13,617 WELL AS THE AMERICAN GENOME 3823 02:43:13,617 --> 02:43:14,218 CENTER. 3824 02:43:14,218 --> 02:43:15,886 WE PLAN TO PURSUE A LARGER 3825 02:43:15,886 --> 02:43:16,854 CLINICAL TRIAL NEXT YEAR AND 3826 02:43:16,854 --> 02:43:19,123 THEN PURSUE BOTH PAYOR 3827 02:43:19,123 --> 02:43:20,224 REIMBURSEMENT AND REGULATORY 3828 02:43:20,224 --> 02:43:20,524 HURDLES. 3829 02:43:20,524 --> 02:43:22,426 WE PLAN TO LAUNCH AS A SERVICE 3830 02:43:22,426 --> 02:43:23,861 AS A LAB DEVELOPED TEST BY THE 3831 02:43:23,861 --> 02:43:28,332 END OF NEXT YEAR. 3832 02:43:28,332 --> 02:43:30,234 SO WHERE THE TEAM PLANS TO TAKE 3833 02:43:30,234 --> 02:43:31,368 THIS TECHNOLOGY TO MARKET, WE 3834 02:43:31,368 --> 02:43:32,903 HAVE 100 YEARS IN HEPATOLOGY, 75 3835 02:43:32,903 --> 02:43:34,438 YEARS IN BUSINESS, 40 YEARS IN 3836 02:43:34,438 --> 02:43:34,772 GENETICS. 3837 02:43:34,772 --> 02:43:36,840 WE'VE HAD FIVE PREVIOUS EXITS 3838 02:43:36,840 --> 02:43:39,343 AND CLOSED ON MORE THAN 3839 02:43:39,343 --> 02:43:41,278 825 MILLION IN FUNDING IN OUR 3840 02:43:41,278 --> 02:43:45,983 PREVIOUS PURSUITS. 3841 02:43:45,983 --> 02:43:47,718 SO ONCE AGAIN OUR TOOLS DO NOT 3842 02:43:47,718 --> 02:43:49,253 REQUIRE FDA APPROVAL TO GET TO 3843 02:43:49,253 --> 02:43:50,487 MARKET BUT RATHER CLIA APPROVAL 3844 02:43:50,487 --> 02:43:52,189 IN WHICH WE CAN LAUNCH AS A 3845 02:43:52,189 --> 02:43:52,690 LAB-DEVELOPED TEST. 3846 02:43:52,690 --> 02:43:54,591 WE'VE HAD TWO STUDIES IN 3847 02:43:54,591 --> 02:43:56,026 PERIPHERAL BLOOD THAT WE'VE 3848 02:43:56,026 --> 02:43:57,328 CONDUCT AND WE HAVE TWO MORE 3849 02:43:57,328 --> 02:43:58,429 STUDIES UNDERWAY WITH THE 3850 02:43:58,429 --> 02:44:02,700 ADDITIONAL SAMPLE SIZE FROM 3851 02:44:02,700 --> 02:44:03,801 ABOUT 2,000 PATIENT SAMPLES. 3852 02:44:03,801 --> 02:44:07,571 WE NOD ABOUT -- WE PLAN TO 3853 02:44:07,571 --> 02:44:10,541 LAUNCH BY Q3 OF NEXT YEAR. 3854 02:44:10,541 --> 02:44:12,042 SO OUR TOOLS CAN BE REIMBURSED 3855 02:44:12,042 --> 02:44:14,678 AT A RATE BETWEEN 650 TO $1,500 3856 02:44:14,678 --> 02:44:15,546 PER PATIENT PER TOOL. 3857 02:44:15,546 --> 02:44:17,681 WE UTILIZE A COMBINATION OF 3858 02:44:17,681 --> 02:44:20,184 THESE FOR REIMBURSEMENT AND WE 3859 02:44:20,184 --> 02:44:23,253 LAUNCH IN THE DC, MARYLAND, 3860 02:44:23,253 --> 02:44:23,854 VIRGINIA AREA. 3861 02:44:23,854 --> 02:44:25,322 WE ARE CURRENTLY RAISING CAPITAL 3862 02:44:25,322 --> 02:44:27,791 TO REACH THE FOLLOWING 3863 02:44:27,791 --> 02:44:28,959 MILESTONES. 3864 02:44:28,959 --> 02:44:30,027 TEST METHOD VERIFICATION WHERE 3865 02:44:30,027 --> 02:44:32,229 WE EXPAND THE SAMPLE SIZE TO 500 3866 02:44:32,229 --> 02:44:34,898 MORE PATIENT SAMPLES, TEST 3867 02:44:34,898 --> 02:44:35,999 METHOD OPTIMIZATION WHERE WE 3868 02:44:35,999 --> 02:44:37,501 COMPARE A COMBINATION OF 3869 02:44:37,501 --> 02:44:38,502 TARGETED BIOMARKERS AND LAST BUT 3870 02:44:38,502 --> 02:44:41,071 NOT LEAST, THE ROLE BUSINESS 3871 02:44:41,071 --> 02:44:42,373 DEVELOPMENT MILESTONES INCLUDING 3872 02:44:42,373 --> 02:44:43,841 CLINICAL AND REGULATORY 3873 02:44:43,841 --> 02:44:45,442 PURSUITS. 3874 02:44:45,442 --> 02:44:47,678 SO WE ARE HUNGRY, HUMBLE AND 3875 02:44:47,678 --> 02:44:48,545 YEARNING FOR PROGRESS. 3876 02:44:48,545 --> 02:44:50,981 OUR MISSION IS NOT ONLY TO HELP 3877 02:44:50,981 --> 02:44:52,049 PATIENTS AGE BUT LOOK BACK AND 3878 02:44:52,049 --> 02:44:53,951 SAY THAT THEY HAVE AGED 3879 02:44:53,951 --> 02:44:54,251 GRACEFULLY. 3880 02:44:54,251 --> 02:45:04,428 THANK YOU. 3881 02:45:06,830 --> 02:45:08,065 >> THANK YOU VERY MUCH, RACHEL. 3882 02:45:08,065 --> 02:45:09,633 SO I'D LIKE TO HAVE EVERYBODY 3883 02:45:09,633 --> 02:45:14,905 BACK ON AND I'LL GO THROUGH SOME 3884 02:45:14,905 --> 02:45:15,639 QUESTIONS. 3885 02:45:15,639 --> 02:45:18,175 SOME OF THESE ARE GOING TO BE 3886 02:45:18,175 --> 02:45:21,345 DIRECTED AT SPECIFIC PEOPLE, 3887 02:45:21,345 --> 02:45:23,914 HOWEVER, IF YOU HAVE ADDITIONAL 3888 02:45:23,914 --> 02:45:28,485 COMMENTS, PLEASE DO WEIGH IN. 3889 02:45:28,485 --> 02:45:34,091 SO TO START OFF FOR DAN, HIV 3890 02:45:34,091 --> 02:45:35,058 DIAGNOSTICS, IS THERE ANY 3891 02:45:35,058 --> 02:45:36,660 CHALLENGE THAT YOU'VE HAD IN 3892 02:45:36,660 --> 02:45:38,629 TRYING TO GARNER INTEREST FROM 3893 02:45:38,629 --> 02:45:46,136 THE OUTSIDE COMMUNITY AND THE 3894 02:45:46,136 --> 02:45:46,737 PERCEPTION/MISPERCEPTION THAT 3895 02:45:46,737 --> 02:45:50,274 THESE TREATMENTS FOR AIDS, HIV, 3896 02:45:50,274 --> 02:45:51,508 IT'S A WELL MANAGED CHRONIC 3897 02:45:51,508 --> 02:45:54,077 CONDITION SO WHY IS SO MUCH MORE 3898 02:45:54,077 --> 02:45:55,212 BEING DONE ON IT? 3899 02:45:55,212 --> 02:45:56,747 I'M NOT ASKING YOU TO JUSTIFY 3900 02:45:56,747 --> 02:45:57,314 IT. 3901 02:45:57,314 --> 02:45:59,116 CAN YOU SAY HOW YOU -- YOU KNOW, 3902 02:45:59,116 --> 02:46:02,719 WHEN YOU APPROACH OUTSIDE 3903 02:46:02,719 --> 02:46:04,121 PARTNERS TO WORK WITH HOW YOU 3904 02:46:04,121 --> 02:46:06,456 COMMUNICATE WHAT A MAJOR HEALTH 3905 02:46:06,456 --> 02:46:08,826 PROBLEM THIS REMAINS? 3906 02:46:08,826 --> 02:46:10,661 >> SURE, YEAH, IT'S ABSOLUTELY 3907 02:46:10,661 --> 02:46:11,495 TRUE. 3908 02:46:11,495 --> 02:46:13,564 THERE'S PLENTY OF GOOD 3909 02:46:13,564 --> 02:46:16,200 DIAGNOSTIC KITS FOR HIV, AND I 3910 02:46:16,200 --> 02:46:18,569 WOULD SAY TO LOTS OF PEOPLE, 3911 02:46:18,569 --> 02:46:20,070 IT'S FAIRLY WELL MANAGED AS LONG 3912 02:46:20,070 --> 02:46:22,506 AS YOU HAVE ENOUGH MONEY. 3913 02:46:22,506 --> 02:46:23,540 AND YOU'RE FORTUNATE ENOUGH TO 3914 02:46:23,540 --> 02:46:25,075 LIVE IN A WEALTHY COUNTRY SUCH 3915 02:46:25,075 --> 02:46:28,479 AS OURS, OR EUROPE, OR JAPAN OR 3916 02:46:28,479 --> 02:46:30,881 CHINA. 3917 02:46:30,881 --> 02:46:33,717 BUT IF YOU GO TO A DIFFERENT 3918 02:46:33,717 --> 02:46:35,085 LOCALE IN THE WORLD, IT'S NOT SO 3919 02:46:35,085 --> 02:46:38,889 WELL MANAGED. 3920 02:46:38,889 --> 02:46:43,694 THE IS THAT TIS T STATISTICS I K 3921 02:46:43,694 --> 02:46:45,429 TO ARE IN AFRICA, IN PARTICULAR 3922 02:46:45,429 --> 02:46:46,930 WHERE THE DISEASE IS REALLY 3923 02:46:46,930 --> 02:46:48,732 BORNE BY YOUNG WOMEN IN A LOT OF 3924 02:46:48,732 --> 02:46:51,468 WAYS, IN WHICH CASE IT'S YOUNG 3925 02:46:51,468 --> 02:46:54,104 WOMEN WHO ARE PURSUED BY OLDER 3926 02:46:54,104 --> 02:46:55,339 MEN, AND THOSE OLDER MEN WILL 3927 02:46:55,339 --> 02:46:58,175 PASS THE DISEASE ON. 3928 02:46:58,175 --> 02:46:59,443 AND SO ANYTHING YOU CAN DO TO 3929 02:46:59,443 --> 02:47:02,112 SORT OF, LIKE, PREVENT AND BLOCK 3930 02:47:02,112 --> 02:47:04,815 THE PROGRESSION OF THAT CYCLE IS 3931 02:47:04,815 --> 02:47:08,752 GOING TO BE A BENEFIT. 3932 02:47:08,752 --> 02:47:10,287 YES, IT'S CERTAINLY AN UPHILL 3933 02:47:10,287 --> 02:47:11,688 BATTLE TO FIND PEOPLE WILLING TO 3934 02:47:11,688 --> 02:47:12,956 SORT OF TAKE ON A DIFFERENT 3935 02:47:12,956 --> 02:47:15,893 APPROACH TO HIV DIAGNOSTICS. 3936 02:47:15,893 --> 02:47:18,896 I THINK THERE'S INTEREST THERE. 3937 02:47:18,896 --> 02:47:21,565 I THINK I'LL KIND OF HIGHLIGHT 3938 02:47:21,565 --> 02:47:22,266 SOMETHING THAT TOM WAS 3939 02:47:22,266 --> 02:47:24,034 MENTIONING TO, WHICH WAS THAT -- 3940 02:47:24,034 --> 02:47:25,402 YEAH, THERE'S REALLY NOT MUCH OF 3941 02:47:25,402 --> 02:47:29,239 A COMMERCIAL INCENTIVE A LOT OF 3942 02:47:29,239 --> 02:47:30,674 TIMES BECAUSE PROFITS ARE 3943 02:47:30,674 --> 02:47:32,876 ESSENTIAL FOR COMPANIES. 3944 02:47:32,876 --> 02:47:37,180 THAT BEING SAID, I THINK ALSO 3945 02:47:37,180 --> 02:47:39,016 FOR ME, I TRY TO CAST IT AS WELL 3946 02:47:39,016 --> 02:47:40,784 AS SORT OF A MORE GLOBAL 3947 02:47:40,784 --> 02:47:43,420 PLATFORM THAT ONE COULD 3948 02:47:43,420 --> 02:47:44,621 POTENTIALLY BUILD ON FOR OTHER 3949 02:47:44,621 --> 02:47:45,455 THINGS AS WELL. 3950 02:47:45,455 --> 02:47:47,624 IF THERE'S AN INTEREST TO GO IN 3951 02:47:47,624 --> 02:47:51,795 A NOVEL DIRECTION. 3952 02:47:51,795 --> 02:47:52,896 SO IT'S JUST SORT OF A 3953 02:47:52,896 --> 02:47:53,864 COMBINATION OF DIFFERENT THINGS, 3954 02:47:53,864 --> 02:47:56,400 AND I'M SURE, TOM, YOU'VE HAD 3955 02:47:56,400 --> 02:47:57,434 SORT OF SIMILAR EXPERIENCES AS 3956 02:47:57,434 --> 02:48:01,271 WELL. 3957 02:48:01,271 --> 02:48:03,140 >> CERTAINLY AGREE WITH WHAT 3958 02:48:03,140 --> 02:48:04,808 DANIEL HAS SAID, BUT I THINK 3959 02:48:04,808 --> 02:48:06,043 THIS ALSO REALLY LEADS INTO SORT 3960 02:48:06,043 --> 02:48:07,077 OF WHAT'S THE ECONOMIC MODEL. 3961 02:48:07,077 --> 02:48:08,545 AND ALSO WHAT'S THE ACTUAL 3962 02:48:08,545 --> 02:48:08,946 UTILITY. 3963 02:48:08,946 --> 02:48:10,647 WE PUT THIS SESSION AS 3964 02:48:10,647 --> 02:48:12,749 DIAGNOSTICS, BUT THERE'S 3965 02:48:12,749 --> 02:48:14,484 ACTUALLY SUBGROUPINGS IN TERMS 3966 02:48:14,484 --> 02:48:16,820 OF HOW THE ON-LABEL INDICATIONS 3967 02:48:16,820 --> 02:48:17,154 ARE USED. 3968 02:48:17,154 --> 02:48:19,690 IS IT A DIAGNOSTIC, IS IT A 3969 02:48:19,690 --> 02:48:23,460 SCREENING ASI, ASSAY, MONITORIG 3970 02:48:23,460 --> 02:48:23,760 ASSAY. 3971 02:48:23,760 --> 02:48:25,963 EACH OF THOSE TYPES OF ASSAYS 3972 02:48:25,963 --> 02:48:28,298 RUNS A SORT OF CLINICAL TRIAL 3973 02:48:28,298 --> 02:48:28,966 EXPRESS. 3974 02:48:28,966 --> 02:48:30,701 THE QUANTIFERON TB ASSAY, FOR 3975 02:48:30,701 --> 02:48:31,768 EXAMPLE, IN THE UNITED STATES 3976 02:48:31,768 --> 02:48:33,937 HAS AN ON-LABEL INDICATION FOR 3977 02:48:33,937 --> 02:48:35,439 TB DIAGNOSIS. 3978 02:48:35,439 --> 02:48:38,408 HOWEVER, THE U.S. CDC AND THE 3979 02:48:38,408 --> 02:48:39,743 WORLD HEALTH ORGANIZATION 3980 02:48:39,743 --> 02:48:40,911 RECOGNIZE AND RECOMMEND THAT 3981 02:48:40,911 --> 02:48:42,813 THIS PRODUCT BE USED FOR PUBLIC 3982 02:48:42,813 --> 02:48:45,983 HEALTH SCREENING PURPOSES. 3983 02:48:45,983 --> 02:48:47,951 WE AS A MANUFACTURER CANNOT 3984 02:48:47,951 --> 02:48:51,288 ADVERTISE FOR OFF-LABEL USES, 3985 02:48:51,288 --> 02:48:54,024 BUT WE CAN CERTAINLY SELL TO THE 3986 02:48:54,024 --> 02:48:55,559 PRACTITIONERS AND LABS WHO MAY 3987 02:48:55,559 --> 02:48:57,494 CHOOSE TO USE IT FOR THEIR OWN 3988 02:48:57,494 --> 02:48:58,462 PURPOSES AND THINGS ON HERE. 3989 02:48:58,462 --> 02:48:59,663 GOING BACK TO DAN'S CASE IN 3990 02:48:59,663 --> 02:49:01,898 TERMS OF HIV, I WOULD SAY YEAH, 3991 02:49:01,898 --> 02:49:03,767 THIS IS ACTUALLY A VERY DYNAMIC 3992 02:49:03,767 --> 02:49:04,868 AREA, THE FACT THAT IT HAS 3993 02:49:04,868 --> 02:49:08,205 BECOME A CHRONIC DISEASE IN THE 3994 02:49:08,205 --> 02:49:09,172 FIRST WORLD AND THE CIRCUMSTANCE 3995 02:49:09,172 --> 02:49:12,009 THAT DAN APPLIES INTO THE 3996 02:49:12,009 --> 02:49:13,176 EMERGING WORLD CERTAINLY IS A 3997 02:49:13,176 --> 02:49:15,178 REASON FOR DOING MUCH WIDE EARLY 3998 02:49:15,178 --> 02:49:17,581 TESTING, NOT FOR DIAGNOSIS, BUT 3999 02:49:17,581 --> 02:49:18,649 FOR IDENTIFYING THE PEOPLE WHO 4000 02:49:18,649 --> 02:49:21,018 NEED TO BE IN MANY WAYS ISOLATED 4001 02:49:21,018 --> 02:49:22,552 SOCIALLY OR WHATEVER WAY TO 4002 02:49:22,552 --> 02:49:26,289 PREVENT THAT FROM BEING 4003 02:49:26,289 --> 02:49:27,724 TRANSMITTED AND EXPANDING UPON 4004 02:49:27,724 --> 02:49:28,325 THAT EPIDEMIC. 4005 02:49:28,325 --> 02:49:30,727 THE EXPANSION AND THE 4006 02:49:30,727 --> 02:49:31,695 EPIDEMIOLOGY WHERE DIAGNOSIS 4007 02:49:31,695 --> 02:49:32,996 INTERPLAYS WITH THAT IS AN 4008 02:49:32,996 --> 02:49:36,433 IMPORTANT PART OF THE DYNAMIC IN 4009 02:49:36,433 --> 02:49:41,638 DIFFERENT REGIONS OF THE WORLD. 4010 02:49:41,638 --> 02:49:43,106 >> TOM, DO YOU WANT TO WEIGH IN 4011 02:49:43,106 --> 02:49:44,841 ON YOUR EXPERIENCE WITH 4012 02:49:44,841 --> 02:49:45,809 IMPORTANT GLOBAL MEDICAL NEEDS 4013 02:49:45,809 --> 02:49:52,716 THAT ARE NOT GOING TO BE ALL IN 4014 02:49:52,716 --> 02:49:53,684 U.S. MARKET -- 4015 02:49:53,684 --> 02:49:57,054 >> RIGHT, I THINK YOU BOTH SORT 4016 02:49:57,054 --> 02:49:59,890 OF MENTIONED THE ISSUE, THAT IN 4017 02:49:59,890 --> 02:50:02,059 ALL THE TPPs, FOR EXAMPLE, FOR 4018 02:50:02,059 --> 02:50:05,929 MANY OF THESE PUBLIC HEALTH 4019 02:50:05,929 --> 02:50:10,567 NEEDS AND DIAGNOSTICS, BESIDES 4020 02:50:10,567 --> 02:50:11,935 BEING -- YOU KNOW, HAVING A 4021 02:50:11,935 --> 02:50:14,438 HIGH DEGREE OF SENSITIVITY AND 4022 02:50:14,438 --> 02:50:16,473 SPECIFICITY AND POSITIVE 4023 02:50:16,473 --> 02:50:17,107 PREDICTIVE VALUE, THE OTHER HAS 4024 02:50:17,107 --> 02:50:21,344 TO DO WITH THE FACT THAT -- HAS 4025 02:50:21,344 --> 02:50:23,480 TO DO WITH COST AND A COST HAS 4026 02:50:23,480 --> 02:50:26,016 TO BE LESS THAN, YOU KNOW, 4027 02:50:26,016 --> 02:50:29,019 IDEALLY LESS THAN A DOLLAR PER 4028 02:50:29,019 --> 02:50:32,055 TEST, AND ACCEPTABLE IS, YOU 4029 02:50:32,055 --> 02:50:35,859 KNOW, $2. 4030 02:50:35,859 --> 02:50:43,166 AND SO IN GENERAL, I'M STILL A 4031 02:50:43,166 --> 02:50:49,406 BELIEVER THAT IT IS INCUMBENT 4032 02:50:49,406 --> 02:50:52,342 UPON THE BIG MANUFACTURERS WHO 4033 02:50:52,342 --> 02:50:53,443 ARE MAKING BILLIONS AND BILLIONS 4034 02:50:53,443 --> 02:50:58,582 OF DOLLARS AS YOU POINTED OUT 4035 02:50:58,582 --> 02:51:01,985 THAT IN SOME WAYS THAT THEY 4036 02:51:01,985 --> 02:51:07,757 UTILIZE SOME OF THAT PROFIT TO, 4037 02:51:07,757 --> 02:51:09,192 YOU KNOW, MAKE A PRODUCT 4038 02:51:09,192 --> 02:51:12,496 AVAILABLE WHERE IT'S NEEDED. 4039 02:51:12,496 --> 02:51:14,297 AND NOT TO SAY THAT IT SHOULD BE 4040 02:51:14,297 --> 02:51:17,701 AT THE EXPENSE OF THINGS THAT 4041 02:51:17,701 --> 02:51:22,973 YOU'RE DOING, BUT I THINK WE'RE 4042 02:51:22,973 --> 02:51:24,141 SPENDING A LOT OF TIME AND 4043 02:51:24,141 --> 02:51:28,812 EFFORT TROYING TO DEVELOP, YOU 4044 02:51:28,812 --> 02:51:33,083 KNOW, POINT OF CARE NUCLEIC ACID 4045 02:51:33,083 --> 02:51:36,453 AMPLIFICATION TESTS YOU CAN GET 4046 02:51:36,453 --> 02:51:37,487 WITHOUT ANY INSTRUMENTATION AND 4047 02:51:37,487 --> 02:51:38,955 WITHOUT ANY MACHINES, AND WE CAN 4048 02:51:38,955 --> 02:51:40,023 DO THIS. 4049 02:51:40,023 --> 02:51:44,194 AND I SORT OF POINT THIS OUT TO 4050 02:51:44,194 --> 02:51:45,162 FUNDERS AND OTHER THINGS, AND 4051 02:51:45,162 --> 02:51:47,964 IT'S IN THE CONTEXT OF HIV. 4052 02:51:47,964 --> 02:51:50,066 THERE'S NOT A CORNER OF AFRICA 4053 02:51:50,066 --> 02:51:51,668 WHERE YOU CAN'T GET AN HIV VIRAL 4054 02:51:51,668 --> 02:51:52,002 LOAD. 4055 02:51:52,002 --> 02:51:55,772 SO WHY CAN'T WE UTILIZE, YOU 4056 02:51:55,772 --> 02:51:57,107 KNOW, MACHINERY AND THE OTHER 4057 02:51:57,107 --> 02:52:01,077 STUFF THAT IS OUT THERE TO TAKE 4058 02:52:01,077 --> 02:52:02,412 SOME OF THESE -- LET'S CALL IT 4059 02:52:02,412 --> 02:52:04,047 BETTER TESTS, THINGS THAT ARE 4060 02:52:04,047 --> 02:52:10,187 GOING TO WORK, AND EVEN USE 4061 02:52:10,187 --> 02:52:10,787 EXISTING INFRASTRUCTURE IF WE 4062 02:52:10,787 --> 02:52:11,354 HAVE TO. 4063 02:52:11,354 --> 02:52:16,193 I DO BELIEVE THAT THERE'S A 4064 02:52:16,193 --> 02:52:18,161 GREAT NEED TO SORT OF MAKE SOME 4065 02:52:18,161 --> 02:52:20,130 OF THESE, YOU KNOW, HUGELY 4066 02:52:20,130 --> 02:52:23,466 BENEFICIAL SORTS OF THINGS 4067 02:52:23,466 --> 02:52:26,336 AVAILABLE TO PEOPLE, AND WHEN 4068 02:52:26,336 --> 02:52:28,138 YOU POINT OUT WITH FATTY LIVER, 4069 02:52:28,138 --> 02:52:29,105 FOR EXAMPLE, PEOPLE THINK, OH, 4070 02:52:29,105 --> 02:52:30,473 YEAH, THIS IS JUST A DISEASE, 4071 02:52:30,473 --> 02:52:33,910 YOU KNOW, OF HIGH-INCOME 4072 02:52:33,910 --> 02:52:36,713 COUNTRIES, BUT NOBODY'S EVER 4073 02:52:36,713 --> 02:52:38,281 LOOKED, YOU KNOW, IN THE PLACES 4074 02:52:38,281 --> 02:52:41,418 WHERE THERE ARE MILLIONS AND 4075 02:52:41,418 --> 02:52:42,118 MILLIONS OF OTHER PEOPLE. 4076 02:52:42,118 --> 02:52:45,021 SO I DO THINK THAT WE JUST HAVE 4077 02:52:45,021 --> 02:52:46,423 TO HAVE A GLOBAL REACH IF WE 4078 02:52:46,423 --> 02:52:49,092 CAN. 4079 02:52:49,092 --> 02:52:50,026 >> THAT'S TRUE. 4080 02:52:50,026 --> 02:52:54,397 ONE THING I'D LIKE TO MENTION 4081 02:52:54,397 --> 02:52:56,132 IS, AND ESPECIALLY DAN AND TOM'S 4082 02:52:56,132 --> 02:52:58,935 WORK POINTS TO IS THAT WE DO 4083 02:52:58,935 --> 02:53:01,671 HAVE A MISSION FOCUS ON GLOBAL 4084 02:53:01,671 --> 02:53:03,673 HEALTH RATHER THAN, YOU KNOW, 4085 02:53:03,673 --> 02:53:06,409 JUST THE BLOCKBUSTER MARKETS. 4086 02:53:06,409 --> 02:53:10,146 AND WE DO WORK WITH FOUNDATIONS 4087 02:53:10,146 --> 02:53:12,949 AND NON-PROFIT COMPANIES WHO ARE 4088 02:53:12,949 --> 02:53:17,287 TRYING TO ADDRESS GLOBAL MEDICAL 4089 02:53:17,287 --> 02:53:18,188 NEEDS AND HAVE THE CHALLENGE 4090 02:53:18,188 --> 02:53:19,356 THAT THEY'RE GOING AFTER THINGS 4091 02:53:19,356 --> 02:53:21,324 WHICH ARE GLOBALLY IMPORTANT, 4092 02:53:21,324 --> 02:53:23,026 BUT NOT GOING TO, YOU KNOW, HAVE 4093 02:53:23,026 --> 02:53:25,328 A GREAT RETURN TO ANY INVESTORS. 4094 02:53:25,328 --> 02:53:29,332 AND SO THEY CAN ALSO LOOK TO NIH 4095 02:53:29,332 --> 02:53:32,402 AS A VERY WILLING PARTNER IN 4096 02:53:32,402 --> 02:53:34,838 THESE TYPES OF -- IN THESE TYPES 4097 02:53:34,838 --> 02:53:38,742 OF CIRCUMSTANCES. 4098 02:53:38,742 --> 02:53:40,677 GO AHEAD, TOM. 4099 02:53:40,677 --> 02:53:41,645 >> CAN I JUST POINT OUT 4100 02:53:41,645 --> 02:53:42,646 SOMETHING? 4101 02:53:42,646 --> 02:53:43,747 I THINK IT WAS BROUGHT UP AS 4102 02:53:43,747 --> 02:53:46,983 WELL BY OUR COLLEAGUES FROM 4103 02:53:46,983 --> 02:53:47,250 MARYLAND. 4104 02:53:47,250 --> 02:53:49,286 YOU KNOW, A LOT OF THE -- WE'LL 4105 02:53:49,286 --> 02:53:55,191 JUST CALL IT INTRAMURAL BASE 4106 02:53:55,191 --> 02:53:58,194 DISCOVERY HAS CERTAINLY BEEN 4107 02:53:58,194 --> 02:54:03,233 USED AS A NIDUS FOR SBIR GRANTS 4108 02:54:03,233 --> 02:54:10,407 BY BIOTECH AND STARTUPS AND 4109 02:54:10,407 --> 02:54:14,444 OTHER SMALL COMPANIES WITH THE 4110 02:54:14,444 --> 02:54:17,080 IDEA THAT IT CAN ACTUALLY GET 4111 02:54:17,080 --> 02:54:18,615 THEM OVER THE HURDLE TO SORT OF 4112 02:54:18,615 --> 02:54:23,320 SHOW THAT THEY CAN GET A PRODUCT 4113 02:54:23,320 --> 02:54:24,888 TOWARDS COMMERCIALIZATION AND 4114 02:54:24,888 --> 02:54:26,756 THEN ALLOW THEM TO GO FOR 4115 02:54:26,756 --> 02:54:29,492 ADDITIONAL, YOU KNOW, ADDITIONAL 4116 02:54:29,492 --> 02:54:31,661 FUNDING, UNDERWRITING IN SOME 4117 02:54:31,661 --> 02:54:32,195 OTHER WAY. 4118 02:54:32,195 --> 02:54:35,231 SO I JUST THINK -- I THINK WE 4119 02:54:35,231 --> 02:54:37,200 CERTAINLY HAVE BEEN INVOLVED AND 4120 02:54:37,200 --> 02:54:40,904 IT SOUNDS LIKE, YOU KNOW, OTHERS 4121 02:54:40,904 --> 02:54:42,038 HAVE -- ON THE CALL HAVE BEEN IN 4122 02:54:42,038 --> 02:54:46,876 SOME WAYS BENEFITED FROM SOME OF 4123 02:54:46,876 --> 02:54:47,477 THAT INTERACTION. 4124 02:54:47,477 --> 02:54:48,945 >> IF I COULD ALSO COMMENT ON 4125 02:54:48,945 --> 02:54:50,580 THIS, THIS IS AN IMPORTANT 4126 02:54:50,580 --> 02:54:54,317 QUESTION, AND THAT IS, YOU KNOW, 4127 02:54:54,317 --> 02:54:58,188 THE UNMET NEED IN SERVING 4128 02:54:58,188 --> 02:54:59,723 DIVERSE WORLDWIDE COMMUNITIES IS 4129 02:54:59,723 --> 02:55:01,358 OBVIOUSLY THERE. 4130 02:55:01,358 --> 02:55:04,327 THE CHALLENGE FOR COMPANIES IS 4131 02:55:04,327 --> 02:55:06,529 THAT THEY HAVE A FIDUCIARY DUTY 4132 02:55:06,529 --> 02:55:08,998 TO THEIR SHA SHAREHOLDERS. 4133 02:55:08,998 --> 02:55:10,633 NOW, IN THE CASE OF A LARGE 4134 02:55:10,633 --> 02:55:15,839 PUBLIC COMPANY LI LIKE QIAGEN, 4135 02:55:15,839 --> 02:55:16,973 THEIR SHAREHOLDERS ALMOST ALWAYS 4136 02:55:16,973 --> 02:55:17,874 WANT A FINANCIAL RETURN. 4137 02:55:17,874 --> 02:55:18,875 HOWEVER, THERE ARE OTHER 4138 02:55:18,875 --> 02:55:19,976 FINANCING MODELS I WOULD LIKE TO 4139 02:55:19,976 --> 02:55:20,477 SHARE. 4140 02:55:20,477 --> 02:55:23,947 ONE OF WHICH, 20/20 I HAVE TO 4141 02:55:23,947 --> 02:55:27,484 SAY WAS A PIONEER IN AND HAVE 4142 02:55:27,484 --> 02:55:28,985 DONE WELL IN WHICH IS CALLED 4143 02:55:28,985 --> 02:55:30,920 PUBLIC EQUITY CROWD FUNDING 4144 02:55:30,920 --> 02:55:32,655 WHICH BECAME LEGAL ABOUT A 4145 02:55:32,655 --> 02:55:37,494 DECADE AGO OR SO, REG -- WE WERE 4146 02:55:37,494 --> 02:55:39,329 AN EARLY SUCCESS IN DOING THAT, 4147 02:55:39,329 --> 02:55:42,399 WE ACTUALLY RAISED OVER 4148 02:55:42,399 --> 02:55:42,999 10 MILLION IN EQUITY CROWD 4149 02:55:42,999 --> 02:55:43,900 FUNDING. 4150 02:55:43,900 --> 02:55:44,901 THE CHALLENGE OF THIS WILL IS 4151 02:55:44,901 --> 02:55:46,569 THAT INVESTORS INVEST -- THEY 4152 02:55:46,569 --> 02:55:47,771 CERTAINLY WANT A FINANCIAL 4153 02:55:47,771 --> 02:55:49,773 RETURN, BUT IT'S NOT NECESSARILY 4154 02:55:49,773 --> 02:55:52,242 THEIR ONLY MOTIVATION. 4155 02:55:52,242 --> 02:55:54,444 EQUITY CROWD FUNDING -- OFTEN 4156 02:55:54,444 --> 02:55:55,779 PEOPLE WILL INVEST IN A REGION 4157 02:55:55,779 --> 02:55:59,349 OR THEIR OWN CITY FOR ECONOMIC 4158 02:55:59,349 --> 02:56:00,750 DEVELOPMENT. 4159 02:56:00,750 --> 02:56:02,519 THEY WILL OFTEN INVEST IN A 4160 02:56:02,519 --> 02:56:03,353 DISEASE THAT THEY CARE ABOUT. 4161 02:56:03,353 --> 02:56:04,988 IT COULD BE SOMETHING IMPACTING 4162 02:56:04,988 --> 02:56:07,157 THEIR FAMILY, IT COULD BE SIMPLY 4163 02:56:07,157 --> 02:56:08,758 FOR PHILANTHROPIC REASONS. 4164 02:56:08,758 --> 02:56:13,263 SO THERE ARE MODELS, 4165 02:56:13,263 --> 02:56:14,030 PARTICULARLY FOR SMALL 4166 02:56:14,030 --> 02:56:14,297 COMPANIES. 4167 02:56:14,297 --> 02:56:15,865 I THINK DANIEL MENTIONED, IF I'M 4168 02:56:15,865 --> 02:56:17,901 NOT MISTAKEN, DON'T JUST THINK 4169 02:56:17,901 --> 02:56:21,805 ABOUT THE ABBOTTS AND ROCHE AND 4170 02:56:21,805 --> 02:56:25,208 THE SIEMENS AND QIAGEN, NO 4171 02:56:25,208 --> 02:56:27,811 DISRESPECT TO RAY, BUT THERE'S 4172 02:56:27,811 --> 02:56:29,679 AN ENTIRE ECOSYSTEM, AND THERE'S 4173 02:56:29,679 --> 02:56:31,614 NOTHING WRONG WITH A COMPANY 4174 02:56:31,614 --> 02:56:35,151 SAYING OUR MISSION IS TO ATTACK 4175 02:56:35,151 --> 02:56:38,321 DISEASE X IN COUNTRY Y. 4176 02:56:38,321 --> 02:56:40,256 BE VERY CLEAR ABOUT IT, AND 4177 02:56:40,256 --> 02:56:42,192 HOPEFULLY YOU'LL HAVE ENOUGH 4178 02:56:42,192 --> 02:56:43,460 SHAREHOLDERS, ENOUGH INVESTORS, 4179 02:56:43,460 --> 02:56:46,696 AND YOU COUPLE THAT WITH GRANTS 4180 02:56:46,696 --> 02:56:49,199 FROM GATES FOUNDATION, SBIR AND 4181 02:56:49,199 --> 02:56:50,834 SO ON AND SO FORTH, YOU CAN 4182 02:56:50,834 --> 02:56:51,901 CREATE A VIABLE BUSINESS. 4183 02:56:51,901 --> 02:56:53,803 IT MAY BE A SMALL BUSINESS, IT'S 4184 02:56:53,803 --> 02:56:55,672 NOT GOING TO BE A BILLION DOLLAR 4185 02:56:55,672 --> 02:56:56,673 COMPANY, IT PROBABLY WON'T WIND 4186 02:56:56,673 --> 02:56:58,641 UP ON THE NEW YORK STOCK 4187 02:56:58,641 --> 02:56:59,943 EXCHANGE, BUT IT'S SERVING ITS 4188 02:56:59,943 --> 02:57:01,711 MISSION. 4189 02:57:01,711 --> 02:57:03,813 AND SO EQUITY CROWD FUND 4190 02:57:03,813 --> 02:57:04,647 SOMETHING SOMETHING THAT'S A 4191 02:57:04,647 --> 02:57:07,350 VERY IMPORTANT TOOL THAT I THINK 4192 02:57:07,350 --> 02:57:08,218 CAN ADVANCE A LOT OF THESE 4193 02:57:08,218 --> 02:57:13,056 GOALS. 4194 02:57:13,056 --> 02:57:14,524 >> TO YOUR POINT, I THINK WHAT 4195 02:57:14,524 --> 02:57:15,758 WE'RE SEEING IN RECENT YEARS IS 4196 02:57:15,758 --> 02:57:20,555 AN INCREASE IN GLOBAL 4197 02:57:20,555 --> 02:57:24,092 STEWARDSHIP, CERTAINLY THE ESG 4198 02:57:24,092 --> 02:57:28,530 MOMOVEMENT IS MOVING INTO THE 4199 02:57:28,530 --> 02:57:30,465 PUBLIC MARKETS NOW WHERE SCC IS 4200 02:57:30,465 --> 02:57:31,132 LOOKING AT VARIOUS 4201 02:57:31,132 --> 02:57:32,000 CERTIFICATIONS FOR COMPANIES AND 4202 02:57:32,000 --> 02:57:33,235 ARE DOING ACTIVITIES IN THIS 4203 02:57:33,235 --> 02:57:34,736 PLACE, AND THE FACT THAT, YOU 4204 02:57:34,736 --> 02:57:38,807 KNOW, THERE IS I THINK AN 4205 02:57:38,807 --> 02:57:39,741 INCREASING RATE IN GLOBAL 4206 02:57:39,741 --> 02:57:40,709 STEWARDSHIP IN GENERAL. 4207 02:57:40,709 --> 02:57:43,712 A RECOGNITION THAT WE DON'T -- 4208 02:57:43,712 --> 02:57:45,213 IN THE UNITED STATES AND WE HAVE 4209 02:57:45,213 --> 02:57:46,281 NOTHING TO DO WITH WHAT'S GOING 4210 02:57:46,281 --> 02:57:46,715 ON AROUND US. 4211 02:57:46,715 --> 02:57:48,216 SO I THINK WE'RE SEEING AN 4212 02:57:48,216 --> 02:57:48,950 AWARENESS. 4213 02:57:48,950 --> 02:57:51,620 CERTAINLY FROM QIAGEN IN OUR 4214 02:57:51,620 --> 02:57:53,888 HISTORY, IT COMES BACK TO GLOBAL 4215 02:57:53,888 --> 02:57:54,422 STEWARDNESS. 4216 02:57:54,422 --> 02:57:55,624 I'VE GIVEN YOU SOME HIGHLIGHTS. 4217 02:57:55,624 --> 02:57:56,524 WE ACTUALLY HAVE DIFFERENT 4218 02:57:56,524 --> 02:57:58,260 PRODUCTS BASED ON -- FROM THE 4219 02:57:58,260 --> 02:58:00,829 SAME INITIAL INVESTMENT THAT THE 4220 02:58:00,829 --> 02:58:01,863 MANIFESTATION OF THE PRODUCT, 4221 02:58:01,863 --> 02:58:03,231 HOW IT ACTUALLY GETS IT, AND 4222 02:58:03,231 --> 02:58:04,666 ALSO THINGS LIKE THE FALSE 4223 02:58:04,666 --> 02:58:06,134 POSITIVE, FALSE NEGATIVE RATIOS, 4224 02:58:06,134 --> 02:58:07,369 THE THRESHOLDS THAT ARE USEFUL 4225 02:58:07,369 --> 02:58:09,638 FOR A PARTICULAR PURPOSE CAN 4226 02:58:09,638 --> 02:58:15,010 VARY ACCORDINGLY. 4227 02:58:15,010 --> 02:58:17,379 BUT QIAGEN HAS EVOLVED INTO A 4228 02:58:17,379 --> 02:58:20,882 LATE STAGE DEVELOPMENT COMPANY. 4229 02:58:20,882 --> 02:58:22,183 WE REALLY THRIVE ON WORKING WITH 4230 02:58:22,183 --> 02:58:23,918 THE SMALLER COMPANIES AND 4231 02:58:23,918 --> 02:58:26,021 STARTUP COMPANIES, AND FROM THIS 4232 02:58:26,021 --> 02:58:27,522 SIDE, WE HAVE A TOOLS 4233 02:58:27,522 --> 02:58:28,523 ORGANIZATION AS WELL AS THE 4234 02:58:28,523 --> 02:58:29,324 DIAGNOSTIC. 4235 02:58:29,324 --> 02:58:31,192 WE'RE FAMILIAR WITH THE ENTIRE 4236 02:58:31,192 --> 02:58:32,394 SPECTRUM ACROSS THERE, AND SO 4237 02:58:32,394 --> 02:58:34,296 YOU CAN GET A LOT -- THERE'S A 4238 02:58:34,296 --> 02:58:35,397 LOT OF EXPERTISE AVAILABLE IN 4239 02:58:35,397 --> 02:58:36,631 WORKING WITH IT, BUT WE 4240 02:58:36,631 --> 02:58:39,267 ABSOLUTELY ARE ONLY ONE PART OF 4241 02:58:39,267 --> 02:58:45,440 IT, AND ONE APROA. T APPROACH. 4242 02:58:45,440 --> 02:58:47,008 >> RACHEL, DO YOU HAVE A COMMENT 4243 02:58:47,008 --> 02:58:47,742 YOU'D LIKE TO MAKE? 4244 02:58:47,742 --> 02:58:50,178 >> I WAS GOING TO SAY SOMEBODY 4245 02:58:50,178 --> 02:58:52,781 WITH THEIR BOOTS ON THE GROUND 4246 02:58:52,781 --> 02:58:54,516 AS AN EARLY STAGE FOUNDER AND 4247 02:58:54,516 --> 02:58:56,251 EARLY STAGE COMPANY, I HAVE SEEN 4248 02:58:56,251 --> 02:58:59,988 A LOT OF -- WITH A GLOBAL FOCUS, 4249 02:58:59,988 --> 02:59:03,158 SO IT'S NOT JUST AN IMPACT IN 4250 02:59:03,158 --> 02:59:04,759 THE UNITED STATES BUT WHAT'S 4251 02:59:04,759 --> 02:59:07,696 OUR -- WHAT IS OUR 4252 02:59:07,696 --> 02:59:10,932 COMMERCIALIZATION PLAN IN THE EU 4253 02:59:10,932 --> 02:59:13,601 IN SOUTH AMERICA AND PLACES OF 4254 02:59:13,601 --> 02:59:16,071 THAT, SO THERE REALLY AND TRULY 4255 02:59:16,071 --> 02:59:17,839 ARE IMPACT, FOR EXAMPLE, WITH 4256 02:59:17,839 --> 02:59:19,708 FATTY LIVER DISEASE, BUT THE 4257 02:59:19,708 --> 02:59:21,476 BURDEN OF DISEASE HASN'T BEEN 4258 02:59:21,476 --> 02:59:24,379 ENTIRELY REALIZED DUE TO THE 4259 02:59:24,379 --> 02:59:27,115 LACK OF FOCUS, ATTENTION, 4260 02:59:27,115 --> 02:59:29,517 EFFECTIVE DIAGNOSTIC TOOLS, SO I 4261 02:59:29,517 --> 02:59:33,388 SEE THAT A LOT FROM EARLY STAGE 4262 02:59:33,388 --> 02:59:35,290 VCs, SOME OF THE LARGER VCs 4263 02:59:35,290 --> 02:59:37,258 AS WELL FOCUSED ON THE SEED 4264 02:59:37,258 --> 02:59:38,360 SERIES A COMPANY, SO REALLY 4265 02:59:38,360 --> 02:59:39,661 THAT'S PART OF THE DISCUSSION 4266 02:59:39,661 --> 02:59:43,098 AND THE STRATEGY FOR A LOT OF 4267 02:59:43,098 --> 02:59:44,532 THE COMPANIES RIGHT NOW, WHAT IS 4268 02:59:44,532 --> 02:59:45,667 OUR PLAN OUTSIDE OF THE UNITED 4269 02:59:45,667 --> 02:59:46,768 STATES AS WELL, BECAUSE I THINK 4270 02:59:46,768 --> 02:59:49,304 IT'S LEADING A LOT OF -- LEAVING 4271 02:59:49,304 --> 02:59:50,038 A LOT OF OPPORTUNITY ON THE 4272 02:59:50,038 --> 02:59:51,573 TABLE TO ONLY FOCUS IN THE 4273 02:59:51,573 --> 02:59:52,006 UNITED STATES. 4274 02:59:52,006 --> 02:59:53,742 TOM, YOU BROUGHT UP A GREAT 4275 02:59:53,742 --> 02:59:56,611 POINT EARLIER WHERE YOU MENTION 4276 02:59:56,611 --> 02:59:58,880 THAT WE THINK OF FATTY LIVER 4277 02:59:58,880 --> 03:00:00,415 DISEASE AS A WESTERNIZED DIET, 4278 03:00:00,415 --> 03:00:01,950 AND TO AN EXTENT, IT IS, BUT 4279 03:00:01,950 --> 03:00:05,987 THAT'S NOT THE ONLY ETIOLOGY. 4280 03:00:05,987 --> 03:00:08,823 I THINK WE'VE BEEN -- AS I THINK 4281 03:00:08,823 --> 03:00:10,058 WE'VE BEEN LED TO BELIEVE. 4282 03:00:10,058 --> 03:00:11,659 SO WHAT ELSE IS FATTY LIVER 4283 03:00:11,659 --> 03:00:12,694 DISEASE, WHAT IS THE INCIDENCE 4284 03:00:12,694 --> 03:00:13,962 AND PREVALENCE AND HOW IS THAT 4285 03:00:13,962 --> 03:00:15,130 CHANGING OVER TIME AND WHY. 4286 03:00:15,130 --> 03:00:16,664 SO I THINK THAT THESE QUESTIONS 4287 03:00:16,664 --> 03:00:19,401 ARE YET TO BE ANSWERED AND 4288 03:00:19,401 --> 03:00:24,105 THERE'S A LOT TO IDENTIFY THERE. 4289 03:00:24,105 --> 03:00:26,207 >> I'M GOING TO GIVE RACHEL THE 4290 03:00:26,207 --> 03:00:27,509 LAST WORD. 4291 03:00:27,509 --> 03:00:30,011 WE WANT TO THANK ALL THE 4292 03:00:30,011 --> 03:00:33,715 PANELISTS FOR A TRULY GREAT 4293 03:00:33,715 --> 03:00:35,550 SESSION ON A VERY IMPORTANT 4294 03:00:35,550 --> 03:00:39,320 TECHNICAL APPROACH, IMPORTANT 4295 03:00:39,320 --> 03:00:39,921 GLOBAL HEALTH CONCERNS. 4296 03:00:39,921 --> 03:00:41,856 SO I JUST WANT TO REMIND THE 4297 03:00:41,856 --> 03:00:45,693 AUDIENCE BEFORE I END THIS ZOOM 4298 03:00:45,693 --> 03:00:47,328 SESSION TO PLEASE GO TO THE 4299 03:00:47,328 --> 03:00:49,364 CONCLUDING REMARKS BY NINA 4300 03:00:49,364 --> 03:00:51,132 SCHOR, ASSOCIATE DIRECTOR OF 4301 03:00:51,132 --> 03:00:53,401 NIH, FOR INTRAMURAL RESEARCH, 4302 03:00:53,401 --> 03:00:56,037 AND THANK YOU AGAIN TO THE 4303 03:00:56,037 --> 03:00:57,405 PANEL, AND HAVE A GOOD REST OF 4304 03:00:57,405 --> 03:00:59,808 YOUR DAY. 4305 03:00:59,808 --> 03:01:00,208 >> THANK YOU. 4306 03:01:00,208 --> 03:01:10,452 >> THANK YOU. 4307 03:01:12,620 --> 03:01:14,856 >> HELLO, AND GOOD AFTERNOON 4308 03:01:14,856 --> 03:01:16,224 FROM BETHESDA, MARYLAND. 4309 03:01:16,224 --> 03:01:16,991 WELCOME AND THANK YOU FOR 4310 03:01:16,991 --> 03:01:19,694 JOINING THE BIOMARKERS AND NOVEL 4311 03:01:19,694 --> 03:01:20,562 OUT COME PANEL. 4312 03:01:20,562 --> 03:01:22,664 WE HAVE AN EXCELLENT LINE OF 4313 03:01:22,664 --> 03:01:24,365 PANELISTS FROM BOTH THE NIH AND 4314 03:01:24,365 --> 03:01:25,900 INDUSTRY. 4315 03:01:25,900 --> 03:01:29,304 MI AM THE MODERATOR OF THIS PANL 4316 03:01:29,304 --> 03:01:29,871 DISCUSSION. 4317 03:01:29,871 --> 03:01:31,372 I'M A RHEUMATOLOGIST BY TRAINING 4318 03:01:31,372 --> 03:01:33,441 AND HEAD OF THE LUPUS CLINICAL 4319 03:01:33,441 --> 03:01:34,776 TRIALS UNIT, WHICH IS PART OF 4320 03:01:34,776 --> 03:01:36,978 THE NATIONAL INSTITUTES OF 4321 03:01:36,978 --> 03:01:37,812 ARTHRITIS, MUSCULOSKELETAL AND 4322 03:01:37,812 --> 03:01:39,113 SKIN DISEASES OF THE INTRAMURAL 4323 03:01:39,113 --> 03:01:41,182 RESEARCH PROGRAM OF THE NIH AND 4324 03:01:41,182 --> 03:01:43,117 HERE IN BETHESDA, MARYLAND. 4325 03:01:43,117 --> 03:01:44,919 I WILL BEGIN BY INTRODUCING ALL 4326 03:01:44,919 --> 03:01:46,855 OF THE PANELISTS FOLLOWED BY A 4327 03:01:46,855 --> 03:01:47,722 BRIEF PRESENTATION BY EACH OF 4328 03:01:47,722 --> 03:01:49,724 THEM. 4329 03:01:49,724 --> 03:01:50,658 PLEASE POST YOUR QUESTIONS IN 4330 03:01:50,658 --> 03:01:53,094 THE LIVE INTERACTION CHAT DURING 4331 03:01:53,094 --> 03:01:54,496 OR AFTER EACH SESSION. 4332 03:01:54,496 --> 03:01:56,331 IF YOUR QUESTION IS DIRECTED TO 4333 03:01:56,331 --> 03:01:58,066 A SPECIFIC PANELIST, PLEASE 4334 03:01:58,066 --> 03:01:59,033 MENTION THEIR NAME IN YOUR 4335 03:01:59,033 --> 03:01:59,901 QUESTION. 4336 03:01:59,901 --> 03:02:01,236 WE WILL RESPOND TO YOUR 4337 03:02:01,236 --> 03:02:04,038 QUESTIONS AT THE END AFTER ALL 4338 03:02:04,038 --> 03:02:05,073 PRESENTATIONS BY OUR PANELISTS 4339 03:02:05,073 --> 03:02:09,644 ARE DONE. 4340 03:02:09,644 --> 03:02:13,915 TH -- WHO WILL SOON BE STARTING 4341 03:02:13,915 --> 03:02:15,183 HIS CAREER AS A MEDICAL STUDENT, 4342 03:02:15,183 --> 03:02:17,919 SO THANK YOU, AMID, FOR 4343 03:02:17,919 --> 03:02:18,686 MODERATING. 4344 03:02:18,686 --> 03:02:20,455 SO I WILL BEGIN BY INTRODUCING 4345 03:02:20,455 --> 03:02:23,958 THE PANELISTS AND THEN I WILL -- 4346 03:02:23,958 --> 03:02:25,260 THEN THEY WILL START THEIR 4347 03:02:25,260 --> 03:02:25,894 PRESENTATIONS. 4348 03:02:25,894 --> 03:02:26,928 AND THEN AFTER THAT, WE WILL DO 4349 03:02:26,928 --> 03:02:27,929 Q & A. 4350 03:02:27,929 --> 03:02:34,736 SO THE FIRST PANELIST IS RICHARD 4351 03:02:34,736 --> 03:02:38,673 SIEGAL, UNIVERSITY OF 4352 03:02:38,673 --> 03:02:39,240 PENNSYLVANIA SCHOOL OF MED 4353 03:02:39,240 --> 03:02:40,742 SIRNTION AND WORKED FOR 20 YEARS 4354 03:02:40,742 --> 03:02:42,443 AT THE NATIONAL INSTITUTES OF 4355 03:02:42,443 --> 03:02:43,444 HEALTH INTRAMURAL RESEARCH 4356 03:02:43,444 --> 03:02:45,413 PROGRAM IN BETHESDA, MARYLAND, 4357 03:02:45,413 --> 03:02:47,715 WHERE HE WAS CHIEF OF THE 4358 03:02:47,715 --> 03:02:48,850 AUTOIMMUNITY BRANCH AND THE 4359 03:02:48,850 --> 03:02:51,986 CLINICAL DIRECTOR OF NIAMS. 4360 03:02:51,986 --> 03:02:53,488 BASIC AND TRANSLATIONAL RESEARCH 4361 03:02:53,488 --> 03:02:56,691 IN CYTOKINE BIOLOGY, FOCUSED ON 4362 03:02:56,691 --> 03:02:58,760 TNF SUPER FAMILY AND RECEPTORS. 4363 03:02:58,760 --> 03:03:01,229 HE JOINED NOVARTIS IN 2018 AS 4364 03:03:01,229 --> 03:03:02,730 THE GLOBAL HEAD OF TRANSLATIONAL 4365 03:03:02,730 --> 03:03:04,599 MEDICINE FOR IMMUNOLOGY. 4366 03:03:04,599 --> 03:03:06,568 AFTER A LONG CAREER IN ACADEMY 4367 03:03:06,568 --> 03:03:07,669 AND RESEARCH. 4368 03:03:07,669 --> 03:03:09,404 AS THE HEAD OF THE 4369 03:03:09,404 --> 03:03:11,172 TRANSCRIPTIONAL MEDICINE FOR 4370 03:03:11,172 --> 03:03:12,106 IMMUNOLOGY, DR. SIEGEL HAS 4371 03:03:12,106 --> 03:03:16,477 OVERSEEN THE TRANSITION OF NEW 4372 03:03:16,477 --> 03:03:18,913 PLEAK ALREADY ENTITIES IN THE 4373 03:03:18,913 --> 03:03:21,482 LAB TO CREATE A BROAD SPECTRUM 4374 03:03:21,482 --> 03:03:26,988 OF AUTOIMMUNE CONDITIONS. 4375 03:03:26,988 --> 03:03:28,590 IN SEPTEMBER OF 2023, HE WAS 4376 03:03:28,590 --> 03:03:30,558 APPOINTED IP I YOU A KNOLL 4377 03:03:30,558 --> 03:03:31,893 RESEARCH DISEASE AREA HEAD AND 4378 03:03:31,893 --> 03:03:32,827 IS LOOKING FORWARD TO CONTINUING 4379 03:03:32,827 --> 03:03:34,028 HIS COMMITMENT IN BRIDGING THE 4380 03:03:34,028 --> 03:03:35,263 GAP BETWEEN LAB AND CLINICAL 4381 03:03:35,263 --> 03:03:36,798 RESEARCH AND DISCOVERING NEW 4382 03:03:36,798 --> 03:03:38,333 TREATMENTS TO IMPROVE THE LIVES 4383 03:03:38,333 --> 03:03:40,335 OF PATIENTS WITH AUTOIMMUNE AND 4384 03:03:40,335 --> 03:03:46,908 INFLAMMATORY DISEASES. 4385 03:03:46,908 --> 03:03:51,112 OUR SECOND PANEL IS SEAN ANJAN 4386 03:03:51,112 --> 03:04:01,789 ARALI -- OFAPPLIED PRECISION OMA 4387 03:04:01,789 --> 03:04:03,491 LASKER CLINICAL RESEARCH TENURE 4388 03:04:03,491 --> 03:04:06,260 TRACK INVESTIGATOR, NIH 4389 03:04:06,260 --> 03:04:06,761 DISTINGUISHED SCHOLAR. 4390 03:04:06,761 --> 03:04:09,864 HE HAS A JOINT APPOINTMENT AND 4391 03:04:09,864 --> 03:04:11,699 IS AN ASSOCIATE PROFESSOR OF 4392 03:04:11,699 --> 03:04:14,002 MEDICINE AT JOHNS HOPKINS SCHOOL 4393 03:04:14,002 --> 03:04:14,369 OF MEDICINE. 4394 03:04:14,369 --> 03:04:16,270 HIS RESEARCH MISSION IS TO 4395 03:04:16,270 --> 03:04:17,605 IMPROVE LUNG TRANSPLANT SURVIVAL 4396 03:04:17,605 --> 03:04:21,743 BY DEVELOPING BETTER DIAGNOSTIC 4397 03:04:21,743 --> 03:04:24,412 AND THERAPIES OF TRANSPLANT 4398 03:04:24,412 --> 03:04:24,812 REJECTION. 4399 03:04:24,812 --> 03:04:28,182 HIS LAB HAS SHOWN THAT A NOVEL 4400 03:04:28,182 --> 03:04:30,918 BLOOD TEST -- DNA RELIABLY 4401 03:04:30,918 --> 03:04:33,254 IDENTIFIES ORGANS AFFECTED BY 4402 03:04:33,254 --> 03:04:35,390 DISEASE PROVIDING A WHOLE BODY 4403 03:04:35,390 --> 03:04:37,792 MOLECULAR INJURY SCAN AND 4404 03:04:37,792 --> 03:04:38,493 IDENTIFIES HIGH RISK PATIENTS 4405 03:04:38,493 --> 03:04:40,762 WHO COULD BENEFIT FROM TAILORED 4406 03:04:40,762 --> 03:04:42,930 STRATEGY TO PREVENT EARLY DEATH. 4407 03:04:42,930 --> 03:04:44,432 HE ESTABLISHED A MULTICENTER 4408 03:04:44,432 --> 03:04:45,867 CONSORTIUM AND IS DIRECTOR OF 4409 03:04:45,867 --> 03:04:48,703 THE GENOMIC RESEARCH ALLIANCE 4410 03:04:48,703 --> 03:04:51,639 FOR TRANSPLANT OR GRAFT, A 4411 03:04:51,639 --> 03:04:53,708 HIGHLY COLLABORATIVE CONSORTIUM 4412 03:04:53,708 --> 03:04:54,809 WITH RESEARCH INFRASTRUCTURE AND 4413 03:04:54,809 --> 03:04:56,277 A LARGE AND DIVERSE PATIENT 4414 03:04:56,277 --> 03:04:58,012 COHORT TO TEST NOVEL THERAPIES 4415 03:04:58,012 --> 03:04:59,280 AND DIAGNOSTIC. 4416 03:04:59,280 --> 03:05:00,615 THE FIRST INTERVENTION CLINICAL 4417 03:05:00,615 --> 03:05:03,451 TRIAL IS PLANNED TO START IN 4418 03:05:03,451 --> 03:05:05,420 2024, AND -- EARLY DETECTION AND 4419 03:05:05,420 --> 03:05:09,357 TREATMENT OF REJECTION GUIDED 4420 03:05:09,357 --> 03:05:11,025 BY -- DNA IMPROVE NON-TRANSPLANT 4421 03:05:11,025 --> 03:05:11,893 OUTCOMES. 4422 03:05:11,893 --> 03:05:19,967 OUR THIRD PANELIST IS MOHAN 4423 03:05:19,967 --> 03:05:23,204 PURUSHOTHAMAN, PROGENTEC 4424 03:05:23,204 --> 03:05:24,305 DIAGNOSTICS, ACTIVELY INVOLVED 4425 03:05:24,305 --> 03:05:26,841 IN EXPLORING NEW TECHNOLOGIES IN 4426 03:05:26,841 --> 03:05:27,909 THE DIAGNOSTICS AND THIER PEW 4427 03:05:27,909 --> 03:05:28,376 TICK AREA. 4428 03:05:28,376 --> 03:05:31,079 HE HOLDS A PH.D. FROM THE JOHNS 4429 03:05:31,079 --> 03:05:32,413 HOPKINS UNIVERSITY WITH A FOCUS 4430 03:05:32,413 --> 03:05:35,016 IN PHARMACEUTICAL PRICING, AND 4431 03:05:35,016 --> 03:05:36,851 PRIOR TO OBTAINING HIS PH.D., HE 4432 03:05:36,851 --> 03:05:38,753 WAS A RESEARCH FELLOW AT 4433 03:05:38,753 --> 03:05:42,857 HARVARD. 4434 03:05:42,857 --> 03:05:47,795 DR. PURUSHOTHAMA NHAS A STRONG 4435 03:05:47,795 --> 03:05:49,630 RECORD IN THERAPEUTIC AND 4436 03:05:49,630 --> 03:05:50,398 DIAGNOSTIC TRACTS. 4437 03:05:50,398 --> 03:05:52,033 HE HAS SEVERAL YEARS OF 4438 03:05:52,033 --> 03:05:54,869 EXPERIENCE IN THE PHARMA 4439 03:05:54,869 --> 03:05:57,538 INDUSTRY FOLLOWED BY STRATEGIC 4440 03:05:57,538 --> 03:05:59,640 ADVISER SO VARIOUS 4441 03:05:59,640 --> 03:06:00,541 PHARMACEUTICAL COMPANIES 4442 03:06:00,541 --> 03:06:02,310 WORLDWIDE, HE SPENT ABOUT FIVE 4443 03:06:02,310 --> 03:06:03,845 YEARS AT ROCHE AND SPEARHEADED 4444 03:06:03,845 --> 03:06:05,346 FORMULATION OF LIFECYCLE PRICING 4445 03:06:05,346 --> 03:06:06,647 STRATEGIES FOR A LARGE NUMBER OF 4446 03:06:06,647 --> 03:06:07,648 PRODUCTS. 4447 03:06:07,648 --> 03:06:09,851 AND THEN HE HAS BUILT A 4448 03:06:09,851 --> 03:06:10,985 SUCCESSFUL PRACTICE AT NET 4449 03:06:10,985 --> 03:06:13,221 MARGIN, WHICH EVENTUALLY WAS 4450 03:06:13,221 --> 03:06:14,655 ACQUIRED BY ALLIANCE LIFE 4451 03:06:14,655 --> 03:06:15,156 SCIENCES. 4452 03:06:15,156 --> 03:06:17,458 AND THEN HE WAS THERE FOR GLOBAL 4453 03:06:17,458 --> 03:06:20,228 PRACTICE LEAD FOR PRICE AND 4454 03:06:20,228 --> 03:06:22,330 MARKETING UNTIL 2014, AND IN 4455 03:06:22,330 --> 03:06:23,498 THESE CHALLENGING ASSIGNMENTS, 4456 03:06:23,498 --> 03:06:24,799 HE GUIDED THE DEVELOPMENT OF 4457 03:06:24,799 --> 03:06:26,000 STRATEGIES FOR A NUMBER OF 4458 03:06:26,000 --> 03:06:27,435 PRODUCTS ACROSS MULTIPLE 4459 03:06:27,435 --> 03:06:29,337 THERAPEUTIC AREAS AND GLOBAL 4460 03:06:29,337 --> 03:06:29,871 MARKETS. 4461 03:06:29,871 --> 03:06:32,206 AND HE HAS BEEN AN ENTREPRENEUR 4462 03:06:32,206 --> 03:06:33,441 RESPONSIBLE FOR GIVING SHAPE TO 4463 03:06:33,441 --> 03:06:36,177 MULTIPLE BUSINESS CONCEPTS AT 4464 03:06:36,177 --> 03:06:37,445 THE CORE OF NEW BUSINESS 4465 03:06:37,445 --> 03:06:39,981 VENTURES AND HE HAS DESIGN AND 4466 03:06:39,981 --> 03:06:42,283 DEVELOPED AN ENTERPRISE SOFTWARE 4467 03:06:42,283 --> 03:06:43,785 THAT HAS NOW BECOME THE LEADING 4468 03:06:43,785 --> 03:06:46,721 PRODUCT USED BY A LARGE NUMBER 4469 03:06:46,721 --> 03:06:49,924 OF MAJOR PHARMA COMPANIES. 4470 03:06:49,924 --> 03:06:55,363 OUR FOURTH PANELIST IS PETER 4471 03:06:55,363 --> 03:06:56,364 BIRBILO, STAFF SCIENTIST IN THE 4472 03:06:56,364 --> 03:06:58,966 LAB OF SENSORY BIOLOGY, NATIONAL 4473 03:06:58,966 --> 03:07:01,569 INSTITUTES OF DENTAL AND 4474 03:07:01,569 --> 03:07:04,071 CRANIOFACIAL RESEARCH AT NIDCR 4475 03:07:04,071 --> 03:07:04,939 AT THE NIH. 4476 03:07:04,939 --> 03:07:06,507 HE RECEIVED HIS PH.D. IN 4477 03:07:06,507 --> 03:07:08,342 PHARMACOLOGY AND TOXICOLOGY FROM 4478 03:07:08,342 --> 03:07:10,411 THE UNIVERSITY OF RHODE ISLAND. 4479 03:07:10,411 --> 03:07:12,814 HIS RESEARCH IS DIRECTED AT 4480 03:07:12,814 --> 03:07:14,048 GENERATING HIGH DEFINITION 4481 03:07:14,048 --> 03:07:15,550 ANTIBODY PROFILES IN CANCER AND 4482 03:07:15,550 --> 03:07:17,118 INFECTIONS AND AUTOIMMUNE 4483 03:07:17,118 --> 03:07:17,685 DISEASES. 4484 03:07:17,685 --> 03:07:18,820 WHICH COULD PROVIDE 4485 03:07:18,820 --> 03:07:20,354 COMPREHENSIVE AND INEXPENSIVE 4486 03:07:20,354 --> 03:07:21,989 CLINICAL TOOLS FOR DISEASE 4487 03:07:21,989 --> 03:07:25,927 PREDICTION, DIAGNOSIS, AND 4488 03:07:25,927 --> 03:07:27,361 MONITORING OF TREATMENT FOR A 4489 03:07:27,361 --> 03:07:28,663 SPECTRUM OF HUMAN DISEASES. 4490 03:07:28,663 --> 03:07:32,934 HIS WORK ON THE LUCIFERASE 4491 03:07:32,934 --> 03:07:36,103 SYSTEMS THAT USES LIGHT EMITTING 4492 03:07:36,103 --> 03:07:38,372 LUCIFERASE FUSION PROTEIN AND 4493 03:07:38,372 --> 03:07:39,907 ASSAY FORMATS TO DETECT ROBUST 4494 03:07:39,907 --> 03:07:40,675 ANTIBODY MARKERS. 4495 03:07:40,675 --> 03:07:42,443 AND THIS IS CLINICALLY 4496 03:07:42,443 --> 03:07:45,146 RELEVANT -- THIS CLINICALLY 4497 03:07:45,146 --> 03:07:46,547 RELEVANT NOVEL BIOMARKER HAS 4498 03:07:46,547 --> 03:07:47,949 INDICATION FOR USE IN A VARIETY 4499 03:07:47,949 --> 03:07:50,284 OF AUTOIMMUNE CONDITIONS SUCH AS 4500 03:07:50,284 --> 03:07:53,754 SJOGREN'S DISEASE, SCLERODERMA 4501 03:07:53,754 --> 03:07:54,388 AND -- NEPHROPATHY. 4502 03:07:54,388 --> 03:07:57,658 HE DEVELOPED A SIMPLE AND ROBUST 4503 03:07:57,658 --> 03:07:59,861 IMMUNOCAPTURE METHOD BASED ON 4504 03:07:59,861 --> 03:08:00,962 LUCIFERASE FUSION PROTEINS 4505 03:08:00,962 --> 03:08:02,730 COUPLED WITH NEW MAGNETS FOR THE 4506 03:08:02,730 --> 03:08:04,432 CLINICAL MEASUREMENT OF ANTIBODY 4507 03:08:04,432 --> 03:08:06,734 LEVELS THAT CAN BE USED FOR THE 4508 03:08:06,734 --> 03:08:09,036 ULTRA RAPID DIAGNOSIS, LESS THAN 4509 03:08:09,036 --> 03:08:11,639 ONE MINUTE OF PATIENTS WITH 4510 03:08:11,639 --> 03:08:14,709 SJOGREN'S DISEASE, HPV 4511 03:08:14,709 --> 03:08:15,810 ASSOCIATED ADENOCARCINOMA AND 4512 03:08:15,810 --> 03:08:17,111 MANY OTHER SUCH DISEASE 4513 03:08:17,111 --> 03:08:17,945 ENTITIES. 4514 03:08:17,945 --> 03:08:19,213 SO THANK YOU, PETER. 4515 03:08:19,213 --> 03:08:23,384 NOW OUR LAST BUT NOT LEAST 4516 03:08:23,384 --> 03:08:33,194 PANELIST IS DR. CHRIS LEPTAK, 4517 03:08:33,194 --> 03:08:35,496 HIS GRADUATE WORK INCLUDED AN MD 4518 03:08:35,496 --> 03:08:42,970 AND PH.D. IN MYOBIOLOGY -- AFTEE 4519 03:08:42,970 --> 03:08:47,008 DID HIS RESIDENCY TRAINING AND 4520 03:08:47,008 --> 03:08:47,875 BRIGHAM AND WOMEN'S HOSPITAL AND 4521 03:08:47,875 --> 03:08:48,876 MASS GENERAL HOSPITAL. 4522 03:08:48,876 --> 03:08:52,647 HE JOINED FDA IN THE GASTROENT 4523 03:08:52,647 --> 03:08:54,849 ROLLING DIVISION. 4524 03:08:54,849 --> 03:08:56,984 PRIMARY FOCUS ON -- AND 4525 03:08:56,984 --> 03:08:57,985 BIOLOGICAL PRODUCT DEVELOP M. 4526 03:08:57,985 --> 03:08:59,287 AFTER JOINING THE OFFICE OF NEW 4527 03:08:59,287 --> 03:09:00,621 DRUG GUIDANCE AND POLICY TEAM, 4528 03:09:00,621 --> 03:09:03,424 HE BECAME OND'S FIRST BIOMARKER 4529 03:09:03,424 --> 03:09:05,493 AND COMPANION DIAGNOSTIC LEAD, 4530 03:09:05,493 --> 03:09:06,827 RESPONSIBLE FOR DEVELOPING 4531 03:09:06,827 --> 03:09:08,763 GUIDANCE AND EVIDENCE 4532 03:09:08,763 --> 03:09:10,031 REQUIREMENTS TO SUPPORT 4533 03:09:10,031 --> 03:09:11,399 REGULATORY ACCEPTANCE. 4534 03:09:11,399 --> 03:09:14,936 HE SERVED AS CHAIR OF -- 4535 03:09:14,936 --> 03:09:18,839 COMMITTEE, GREU THE GROUP OF SER 4536 03:09:18,839 --> 03:09:20,374 STAFF FOR NOVEL SURROGATE END 4537 03:09:20,374 --> 03:09:22,576 POINTS AND ACCEPTANCE OF DDT 4538 03:09:22,576 --> 03:09:23,811 QUALIFICATION SUBMISSIONS. 4539 03:09:23,811 --> 03:09:25,613 FOUNDED AND CHAIRED AN FDA WIDE 4540 03:09:25,613 --> 03:09:26,948 BIOMARKER WORKING GROUP AND 4541 03:09:26,948 --> 03:09:28,916 AFTER 14 YEARS OF WORKING AT 4542 03:09:28,916 --> 03:09:31,886 FDA, HE JOINED GREENLEAF IN 2021 4543 03:09:31,886 --> 03:09:33,487 AS EXECUTIVE VICE PRESIDENT OF 4544 03:09:33,487 --> 03:09:34,755 DRUG AND BIOLOGICAL PRODUCTS. 4545 03:09:34,755 --> 03:09:37,325 HE SPECIALIZES IN REGULATORY USE 4546 03:09:37,325 --> 03:09:40,528 OF NOVEL CLINICAL END POINTS, 4547 03:09:40,528 --> 03:09:42,596 INCLUDING -- FOR BOTH 4548 03:09:42,596 --> 03:09:44,532 TRADITIONAL AND ACCELERATED 4549 03:09:44,532 --> 03:09:45,733 MARKETING APPROVAL AND 4550 03:09:45,733 --> 03:09:47,034 SCIENTIFIC ADVANCE, ADVICE AND 4551 03:09:47,034 --> 03:09:48,336 TECHNICAL DIRECTION ON CRITICAL 4552 03:09:48,336 --> 03:09:49,470 ASPECT OF DRUG DEVELOPMENT. 4553 03:09:49,470 --> 03:09:54,709 SO AS YOU CAN SEE, WE HAVE A 4554 03:09:54,709 --> 03:09:55,943 EXCELLENT LINEUP OF PANELISTS 4555 03:09:55,943 --> 03:09:57,311 AND WE ARE ALL LOOKING FORWARD 4556 03:09:57,311 --> 03:10:01,282 TO HEAR FROM THEM AND SEE HOW WE 4557 03:10:01,282 --> 03:10:03,250 CAN LEARN FROM THEM IN THIS 4558 03:10:03,250 --> 03:10:07,388 FIRST EVER NIH INDUSTRY SEMINAR. 4559 03:10:07,388 --> 03:10:09,357 SO THANK YOU TO ALL OF THE 4560 03:10:09,357 --> 03:10:11,125 PANELISTS, AND THEN I WOULD 4561 03:10:11,125 --> 03:10:14,929 REQUEST RICHARD TO PLEASE TAKE 4562 03:10:14,929 --> 03:10:15,162 IT AWAY. 4563 03:10:15,162 --> 03:10:19,333 THANK YOU. 4564 03:10:19,333 --> 03:10:19,967 >> THANK YOU. 4565 03:10:19,967 --> 03:10:27,108 CAN YOU ALL SEE MY SCREEN? 4566 03:10:27,108 --> 03:10:27,842 >> YES. 4567 03:10:27,842 --> 03:10:28,275 >> GREAT. 4568 03:10:28,275 --> 03:10:29,710 SO REALLY, THANK YOU, VERY HAPPY 4569 03:10:29,710 --> 03:10:31,912 TO BE HERE. 4570 03:10:31,912 --> 03:10:36,817 AS SARFARAZ SAID, I SPENT 20 4571 03:10:36,817 --> 03:10:38,786 YEARS AS A LAB INVESTIGATOR AND 4572 03:10:38,786 --> 03:10:40,454 ALSO AS CLINICAL DIRECTOR SO I'M 4573 03:10:40,454 --> 03:10:41,422 REALLY FAMILIAR WITH THE LAB AND 4574 03:10:41,422 --> 03:10:42,723 CLINICAL PROGRAMS AT NIH AND 4575 03:10:42,723 --> 03:10:44,492 REALLY HAPPY TO REFLECT ON BOTH 4576 03:10:44,492 --> 03:10:46,927 SOME OF THE WAYS THAT WE NOW IN 4577 03:10:46,927 --> 03:10:50,064 MY NEW POSITION AT NOVARTIS 4578 03:10:50,064 --> 03:10:53,467 LARGE PHARMA COMPANY WITH A VERY 4579 03:10:53,467 --> 03:10:56,837 LARGE RESEARCH GROUP INTERACT 4580 03:10:56,837 --> 03:11:00,674 WITH BOTH EXTERNAL PARTNERS AND 4581 03:11:00,674 --> 03:11:01,976 NIH IN PARTICULAR, AND I'LL KIND 4582 03:11:01,976 --> 03:11:04,412 OF GIVE TWO CASE STUDIES OF 4583 03:11:04,412 --> 03:11:05,513 PARTLY ONE FROM THE WORK I DID 4584 03:11:05,513 --> 03:11:07,581 AT NIH, AND HOW WE TRIED TO 4585 03:11:07,581 --> 03:11:10,518 DEVELOP A NOVEL THERAPEUTIC AND 4586 03:11:10,518 --> 03:11:13,387 THEN ALSO A VERY SUCCESSFUL CASE 4587 03:11:13,387 --> 03:11:15,256 WHERE NOVARTIS DEVELOPED A 4588 03:11:15,256 --> 03:11:16,657 THERAPEUTIC WITH THE NIH 4589 03:11:16,657 --> 03:11:17,658 CLINICAL CENTER AS THE MAIN 4590 03:11:17,658 --> 03:11:20,861 CLINICAL SITE. 4591 03:11:20,861 --> 03:11:23,064 SO I THINK THE WAY I'VE COME TO 4592 03:11:23,064 --> 03:11:26,300 SEE THAT THE INTERFACE BETWEEN 4593 03:11:26,300 --> 03:11:27,068 INTERNAL/EXTERNAL IS REALLY 4594 03:11:27,068 --> 03:11:28,536 AROUND THE CYCLE OF DISCOVERY. 4595 03:11:28,536 --> 03:11:30,237 SO WE THINK OF DRUG DEVELOPMENT 4596 03:11:30,237 --> 03:11:31,872 AS A PIPELINE BUT IT REALLY MUCH 4597 03:11:31,872 --> 03:11:33,307 MORE OF A CYCLE WHERE TARGETS 4598 03:11:33,307 --> 03:11:37,044 ARE IDENTIFIED, BIOMARCS ARE BIE 4599 03:11:37,044 --> 03:11:38,479 DISCOVERED AND DRUG CANDIDATES 4600 03:11:38,479 --> 03:11:40,448 ARE ADVANCED IN PRE-CLINICAL 4601 03:11:40,448 --> 03:11:43,084 TESTING AND CLINICAL TRIALS. 4602 03:11:43,084 --> 03:11:44,952 IMPORTANTLY TISSUE SAMPLES ARE 4603 03:11:44,952 --> 03:11:45,820 COLLECTED IN THOSE TRIALS, WHICH 4604 03:11:45,820 --> 03:11:47,888 CAN BE A VERY IMPORTANT PART OF 4605 03:11:47,888 --> 03:11:49,657 GOING BACK INTO HUMAN TISSUE AND 4606 03:11:49,657 --> 03:11:50,991 DATA ANALYSIS, BOTH 4607 03:11:50,991 --> 03:11:52,493 INTERVENTIONAL TRIALS AND LARGE 4608 03:11:52,493 --> 03:11:55,196 CONSORTIA OF NON-INTERVENTIONAL 4609 03:11:55,196 --> 03:11:59,433 TRIALS, AND ALL THOSE DIFFERENT 4610 03:11:59,433 --> 03:12:02,103 PHASES CAN BE MARKED BY INTERNAL 4611 03:12:02,103 --> 03:12:03,637 AND EXTERNAL COLLABORATION. 4612 03:12:03,637 --> 03:12:04,972 SO BOTH COLLABORATIONS WITH 4613 03:12:04,972 --> 03:12:06,173 SINGLE LABS AND INSTITUTIONS TO 4614 03:12:06,173 --> 03:12:07,241 REBLIND THAT EVERY SINGLE 4615 03:12:07,241 --> 03:12:08,109 CLINICAL TRIAL IS A 4616 03:12:08,109 --> 03:12:10,344 COLLABORATION, THERE'S NO KNOW 4617 03:12:10,344 --> 03:12:11,679 NOVARTIS CLINIC, MERCK CLINIC. 4618 03:12:11,679 --> 03:12:12,980 EVERYTHING IS DONE EXTERNALLY 4619 03:12:12,980 --> 03:12:14,615 WITH UNIVERSITIES AND THE NIH 4620 03:12:14,615 --> 03:12:16,617 CLINICAL CENTER AND THE CLINIC. 4621 03:12:16,617 --> 03:12:19,854 WE ALSO PARTICIPATE, OUR LARGER 4622 03:12:19,854 --> 03:12:21,722 PHARMA COMPANIES PARTICIPATE IN 4623 03:12:21,722 --> 03:12:22,656 PUBLIC-PRIVATE NETWORKS. 4624 03:12:22,656 --> 03:12:24,391 IN THE U.S., THE ADVANCING 4625 03:12:24,391 --> 03:12:26,660 MEDICINES PARTNERSHIP IS REALLY 4626 03:12:26,660 --> 03:12:27,962 THE PREMIERE ONE OVER THE LAST 4627 03:12:27,962 --> 03:12:28,829 10 YEARS NOW, THEY'RE ABOUT TO 4628 03:12:28,829 --> 03:12:30,297 HAVE A TENTH ANNIVERSARY. 4629 03:12:30,297 --> 03:12:32,466 AND THEN ALSO IN EUROPE, THERE'S 4630 03:12:32,466 --> 03:12:35,736 A VERY STRONG ORGANIZATION 4631 03:12:35,736 --> 03:12:37,905 SPONSORED BY THE EU, INNOVATIVE 4632 03:12:37,905 --> 03:12:39,974 MEDICINE INITIATIVES, NOW CALLED 4633 03:12:39,974 --> 03:12:40,908 INNOVATIVE HEALTH INITIATIVES 4634 03:12:40,908 --> 03:12:43,844 THAT ARE ALSO PUBLIC-PRIVATE 4635 03:12:43,844 --> 03:12:46,447 PARTNERSHIPS. 4636 03:12:46,447 --> 03:12:48,082 IN ADDITION, AS HAS BEEN DONE 4637 03:12:48,082 --> 03:12:53,687 OFTEN AT NIH, SPONSORED TRIALS, 4638 03:12:53,687 --> 03:12:54,421 INVESTIGATOR INITIATED TRIALS 4639 03:12:54,421 --> 03:12:55,489 CAN HAVE ADDITIONAL RESEARCH 4640 03:12:55,489 --> 03:12:58,058 THAT CAN GO BACK INTO THE 4641 03:12:58,058 --> 03:13:02,329 PIPELINE. 4642 03:13:02,329 --> 03:13:03,230 COLLABORATIONS FROM THE PHARMA 4643 03:13:03,230 --> 03:13:04,298 POINT OF VIEW COME IN MANY 4644 03:13:04,298 --> 03:13:05,065 TYPES, AND IT'S IMPORTANT TO 4645 03:13:05,065 --> 03:13:06,267 REMEMBER THAT UNIVERSITIES AND 4646 03:13:06,267 --> 03:13:10,437 NIH ARE JUST ONE TYPE, THROUGH 4647 03:13:10,437 --> 03:13:13,741 CRADAs, MTAs, CTAs AND 4648 03:13:13,741 --> 03:13:14,942 NOVARTIS DOES A LOT OF THAT ALL 4649 03:13:14,942 --> 03:13:16,977 OVER THE WORLD. 4650 03:13:16,977 --> 03:13:19,513 THERE'S ALSO THE PUBLIC-PRIVATE 4651 03:13:19,513 --> 03:13:21,982 PARTNERSHIPS THAT I MENTIONED, 4652 03:13:21,982 --> 03:13:23,083 MEETINGS. 4653 03:13:23,083 --> 03:13:24,552 ONE IMPORTANT THING TO MENTION 4654 03:13:24,552 --> 03:13:28,455 THAT HAS COME UP AND WAS SAID IN 4655 03:13:28,455 --> 03:13:29,890 SOME OF THE TALKS EARLIER, IT IS 4656 03:13:29,890 --> 03:13:31,358 MUCH EASIER, THERE'S A 4657 03:13:31,358 --> 03:13:32,293 COMPLETELY DIFFERENT PATHWAY TO 4658 03:13:32,293 --> 03:13:33,661 PARTNER WITH A SMALL BIOTECH, 4659 03:13:33,661 --> 03:13:35,896 WHICH IS I THINK THE BIGGEST 4660 03:13:35,896 --> 03:13:37,965 DISADVANTAGE OF NIH, NOT BEING 4661 03:13:37,965 --> 03:13:40,501 ABLE TO EASILY SPIN OFF FOR 4662 03:13:40,501 --> 03:13:41,835 BIOTECH, IT JUST A STANDARD 4663 03:13:41,835 --> 03:13:43,871 METHOD OF OPERATION OF MANY 4664 03:13:43,871 --> 03:13:44,638 ACADEMIC LABS. 4665 03:13:44,638 --> 03:13:46,173 SO ONCE THERE'S A SMALL BIOTECH, 4666 03:13:46,173 --> 03:13:48,642 NO MATTER HOW SMALL, THAT GOES 4667 03:13:48,642 --> 03:13:49,910 TO PARTNERING, AND THERE'S A 4668 03:13:49,910 --> 03:13:51,278 WHOLE ARMY OF PEOPLE THAT WORK 4669 03:13:51,278 --> 03:13:52,446 AT EVERY PHARMA COMPANIES THAT 4670 03:13:52,446 --> 03:13:53,981 ARE SCANNING THE WORLD FOR 4671 03:13:53,981 --> 03:13:55,182 POTENTIAL PARTNERING. 4672 03:13:55,182 --> 03:13:57,251 AND SO THE ACADEMIC PARTNERSHIPS 4673 03:13:57,251 --> 03:13:59,320 HAVE TO BE MUCH MORE SPEARHEADED 4674 03:13:59,320 --> 03:14:02,723 BY THE SCIENTISTS, THE 4675 03:14:02,723 --> 03:14:03,757 SCIENTIST-SCIENTIST INTERACTIONS 4676 03:14:03,757 --> 03:14:04,592 BUT THEY ALSO CAN BE VERY 4677 03:14:04,592 --> 03:14:05,259 PRODUCTIVE. 4678 03:14:05,259 --> 03:14:07,962 PHARMA COMPANIES ALSO SPONSOR 4679 03:14:07,962 --> 03:14:09,496 THROUGH MOST PHARMA COMPANIES 4680 03:14:09,496 --> 03:14:12,466 HAVE VENTURE CAPITAL ARMS THAT 4681 03:14:12,466 --> 03:14:14,235 SPONSOR WITHOUT OBLIGATION TO 4682 03:14:14,235 --> 03:14:19,573 DEVELOP EVEN EARLIER STARTUPS 4683 03:14:19,573 --> 03:14:22,743 AND THERE'S ALSO INCUBATORS OR 4684 03:14:22,743 --> 03:14:26,814 NETWORKING. 4685 03:14:26,814 --> 03:14:28,115 SO THE FIRST CASE STUDY I WANT 4686 03:14:28,115 --> 03:14:31,852 TO TALK ABOUT IS SOMETHING CLOSE 4687 03:14:31,852 --> 03:14:33,053 TO ACTIVITIES THAT I DID FOR A 4688 03:14:33,053 --> 03:14:33,921 LONG TIME AT NIH. 4689 03:14:33,921 --> 03:14:38,092 I WAS STUDYING IN TNF FAMILY 4690 03:14:38,092 --> 03:14:41,028 BIOLOGY AND WE MADE THE 4691 03:14:41,028 --> 03:14:41,996 OBSERVATION ALONG WITH A NUMBER 4692 03:14:41,996 --> 03:14:45,165 OF OTHER COLLEAGUES FROM NIH 4693 03:14:45,165 --> 03:14:47,568 THAT ONE OF THOSE FAMILY 4694 03:14:47,568 --> 03:14:51,171 MEMBERS, TL1A WHEN OVEREXPRESSED 4695 03:14:51,171 --> 03:14:53,941 CAUSED A INTESTINAL INFLAMMATION 4696 03:14:53,941 --> 03:14:55,409 WITH SOME SIMILARITIES TO 4697 03:14:55,409 --> 03:14:57,011 CROHN'S DISEASE AND UC, AND THIS 4698 03:14:57,011 --> 03:15:00,281 SAME CYTOKINE IS ALSO A MAJOR 4699 03:15:00,281 --> 03:15:01,915 GENETIC RISK FOR THE DEVELOPMENT 4700 03:15:01,915 --> 03:15:04,318 OF CROHN'S AND ULCERATIVE 4701 03:15:04,318 --> 03:15:04,718 COLIGHT. 4702 03:15:04,718 --> 03:15:06,654 SO THAT WAS BACK IN 2010. 4703 03:15:06,654 --> 03:15:09,723 SO THIS IS KIND OF A TYPICAL 4704 03:15:09,723 --> 03:15:10,124 THING. 4705 03:15:10,124 --> 03:15:11,659 I WAS A JUNIOR INVESTIGATOR AT 4706 03:15:11,659 --> 03:15:15,863 THAT TIME, AND WE MADE 4707 03:15:15,863 --> 03:15:17,798 ANTIBODIES AGAINST THE HUMAN 4708 03:15:17,798 --> 03:15:19,333 CYTOKINE, FILED AN INVENTION 4709 03:15:19,333 --> 03:15:21,135 REPORT AS WE'RE ENCOURAGED TO 4710 03:15:21,135 --> 03:15:24,505 DO, WHICH WAS GRANTED, WE ALSO 4711 03:15:24,505 --> 03:15:26,440 CHARACTERIZED THE SNP AND THE 4712 03:15:26,440 --> 03:15:28,342 FUNCTIONAL IMPLICATIONS OF THE 4713 03:15:28,342 --> 03:15:32,046 PROMOTOR SNP THAT'S LINKED TO 4714 03:15:32,046 --> 03:15:33,580 SUSCEPTIBILITY. 4715 03:15:33,580 --> 03:15:34,782 I WENT AROUND TO MANY COMPANIES 4716 03:15:34,782 --> 03:15:36,016 AND DID -- PARTNERSHIPS. 4717 03:15:36,016 --> 03:15:38,419 THIS IS WHERE I JUST RECOGNIZED 4718 03:15:38,419 --> 03:15:40,287 JUST MAKING A MONOCLONAL 4719 03:15:40,287 --> 03:15:42,056 ANTIBODY WITH A PA NENT ON IT IS 4720 03:15:42,056 --> 03:15:45,092 NOT SUS A VALUABLE COMMODITY FOR 4721 03:15:45,092 --> 03:15:46,060 BIOTECH OR PHARMA BECAUSE IT'S 4722 03:15:46,060 --> 03:15:49,063 SO EASY TO MAKE MONOCLONAL 4723 03:15:49,063 --> 03:15:51,332 ANTIBODIES. 4724 03:15:51,332 --> 03:15:54,301 NEVERTHELESS, AS AN NIH 4725 03:15:54,301 --> 03:15:56,136 INVESTIGATOR, THERE'S A LICENSE 4726 03:15:56,136 --> 03:15:58,238 TO A STARTUP THAT AS FAR AS I 4727 03:15:58,238 --> 03:16:01,208 KNOW HAS NOT DEVELOPED THE 4728 03:16:01,208 --> 03:16:02,142 ANTIBODY, BUT I THINK THAT WAS 4729 03:16:02,142 --> 03:16:06,347 SORT OF OUR EXPERIENCE AND ONE 4730 03:16:06,347 --> 03:16:07,214 ASPECT IN PARTNERING. 4731 03:16:07,214 --> 03:16:08,882 BUT I JUST WANT TO CONTRAST THAT 4732 03:16:08,882 --> 03:16:12,152 TO WHAT HAPPENED AT A VERY 4733 03:16:12,152 --> 03:16:15,989 COMMERCIALLY ORIENTED ACADEMIC 4734 03:16:15,989 --> 03:16:17,057 SETTING, CEDARS-SINAI, WHERE 4735 03:16:17,057 --> 03:16:20,160 ANOTHER INVESTIGATOR, WHO WAS A 4736 03:16:20,160 --> 03:16:22,129 GASTROENTEROLOGIST, FOUND A 4737 03:16:22,129 --> 03:16:24,631 SIMILAR OBSERVATION IN MICE BUT 4738 03:16:24,631 --> 03:16:30,104 THEN AS HAPPENS IN ACADEMIA, THE 4739 03:16:30,104 --> 03:16:31,438 UNIVERSITY CO-SPONSORED THE 4740 03:16:31,438 --> 03:16:32,873 STARTUP, THE STARTUP BECAME A 4741 03:16:32,873 --> 03:16:36,877 PUBLIC COMPANY, DEVELOPED THE 4742 03:16:36,877 --> 03:16:38,245 ANTITHERAPEUTIC ANTIBODY AND 4743 03:16:38,245 --> 03:16:38,979 IMPORTANTLY FOR THIS 4744 03:16:38,979 --> 03:16:41,382 CONVERSATION, DEVELOPED A 4745 03:16:41,382 --> 03:16:42,416 COMPLEMENTARY DIAGNOSTIC BASED 4746 03:16:42,416 --> 03:16:44,785 ON THOSE SNPs THAT WE HAD ALSO 4747 03:16:44,785 --> 03:16:46,320 WORKED ON, AND THEN VERY 4748 03:16:46,320 --> 03:16:47,988 EXCITING FOR THE FIELD, AND I 4749 03:16:47,988 --> 03:16:49,323 VIEW THIS AS GREAT SUCCESS OF 4750 03:16:49,323 --> 03:16:52,793 ALL OF OUR WORK IN THIS AREA, A 4751 03:16:52,793 --> 03:16:55,229 CLINICAL TRIAL DEMONSTRATED THAT 4752 03:16:55,229 --> 03:16:57,531 THE ANTIBODY WAS EFFECTIVE AND 4753 03:16:57,531 --> 03:16:59,600 ALSO THE BIOMARKER PREDICTED 4754 03:16:59,600 --> 03:17:01,502 SIGNIFICANT ENRICHMENT OF 4755 03:17:01,502 --> 03:17:02,403 REMISSION AND THEN THIS COMPANY 4756 03:17:02,403 --> 03:17:06,306 WAS ACQUIRED BY MERCK FOR 4757 03:17:06,306 --> 03:17:07,341 $10.8 BILLION, AND THE 4758 03:17:07,341 --> 03:17:09,209 SPONSOR -- THIS IS THE POTENTIAL 4759 03:17:09,209 --> 03:17:14,214 THAT NIH RARELY EXPERIENCES, THE 4760 03:17:14,214 --> 03:17:15,482 LEADING INVESTOR AT THE 4761 03:17:15,482 --> 03:17:16,417 UNIVERSITY EXPERIENCED A VERY 4762 03:17:16,417 --> 03:17:17,951 LARGE CAPITAL GAIN FROM THEIR 4763 03:17:17,951 --> 03:17:18,285 INVESTMENT. 4764 03:17:18,285 --> 03:17:20,687 BUT I THINK THAT ILLUSTRATES 4765 03:17:20,687 --> 03:17:22,890 SOME OF THE ADVANTAGES AND 4766 03:17:22,890 --> 03:17:25,626 PITFALLS OF THE NIH IRP AS A 4767 03:17:25,626 --> 03:17:27,494 PLACE, THERE'S BEEN MANY MORE 4768 03:17:27,494 --> 03:17:28,595 SUCCESSFUL EFFORTS THAN THIS 4769 03:17:28,595 --> 03:17:29,696 ONE, BUT I THINK IT DOES 4770 03:17:29,696 --> 03:17:31,965 ILLUSTRATE SOME OF THE ISSUES. 4771 03:17:31,965 --> 03:17:33,634 THE SECOND ONE, IT'S A VERY 4772 03:17:33,634 --> 03:17:37,604 DIFFERENT STORY SINCE THIS WAS 4773 03:17:37,604 --> 03:17:39,106 PN3 KINASE DELTA, AN ENZYME 4774 03:17:39,106 --> 03:17:41,408 DOWNSTREAM OF B CELERY SPEP TORE 4775 03:17:41,408 --> 03:17:42,876 AND OTHER SIGNALING MOLECULES, 4776 03:17:42,876 --> 03:17:45,045 AND IT WAS REALIZED IN THE EARLY 4777 03:17:45,045 --> 03:17:47,848 TWO THOUSANDS THAT THIS COULD BE 4778 03:17:47,848 --> 03:17:49,216 A GOOD DRUG TARGET, SO THIS 4779 03:17:49,216 --> 03:17:53,754 STORY BEGAN THE OPPOSITE WAY, SO 4780 03:17:53,754 --> 03:17:55,322 IN 2010, AT MY GROUP, BEFORE MY 4781 03:17:55,322 --> 03:17:57,191 TIME IN NOVARTIS, THIS WAS 4782 03:17:57,191 --> 03:18:00,394 IDENTIFIED AS A POTENTIAL TARGET 4783 03:18:00,394 --> 03:18:02,196 TO WHERE MULTIPLE DIFFERENT 4784 03:18:02,196 --> 03:18:04,731 AUTOIMMUNE DISEASES, AND IT WAS 4785 03:18:04,731 --> 03:18:06,266 A -- A CLINICAL CANDIDATE WAS 4786 03:18:06,266 --> 03:18:07,901 MADE, IT WAS A FIRST IN HUMAN 4787 03:18:07,901 --> 03:18:09,269 AND REALLY WITH NO INTENTION OF 4788 03:18:09,269 --> 03:18:11,905 GOING INTO A GENETIC DISEASE 4789 03:18:11,905 --> 03:18:14,408 TARGET, BUT THEN IN 2013, ALMOST 4790 03:18:14,408 --> 03:18:16,477 EXACTLY 10 YEARS AGO, MIKE 4791 03:18:16,477 --> 03:18:19,213 LEONARDO AND NIAID AND OTHER 4792 03:18:19,213 --> 03:18:20,848 INVESTIGATORS IN THE UK 4793 03:18:20,848 --> 03:18:21,982 DISCOVERED A GENETIC SYNDROME 4794 03:18:21,982 --> 03:18:24,051 CAUSED AN IMMUNODYSREGULATION 4795 03:18:24,051 --> 03:18:25,486 SYNDROME CAUSED BY GAIN OF 4796 03:18:25,486 --> 03:18:27,254 FUNCTION MUTATIONS IN THIS EXACT 4797 03:18:27,254 --> 03:18:28,889 ENZYME. 4798 03:18:28,889 --> 03:18:30,524 AND THAT LED TO VERY RAPID 4799 03:18:30,524 --> 03:18:31,825 COLLABORATION BECAUSE IT'S MUCH 4800 03:18:31,825 --> 03:18:33,160 MORE STRAIGHTFORWARD AND THIS IS 4801 03:18:33,160 --> 03:18:37,364 WHERE I THINK THE NIH AS AN 4802 03:18:37,364 --> 03:18:38,732 ENTITY THAT STUDIES A LOT OF 4803 03:18:38,732 --> 03:18:40,167 RARE DISEASES CAN REALLY SHINE. 4804 03:18:40,167 --> 03:18:41,935 IT WAS QUICKLY REALIZED THAT 4805 03:18:41,935 --> 03:18:43,470 THESE PATIENT, NIH WAS THE 4806 03:18:43,470 --> 03:18:46,507 LARGEST CENTER WITH NIAID AND 4807 03:18:46,507 --> 03:18:48,842 HIS PATIENTS, WOULD BE A GREAT 4808 03:18:48,842 --> 03:18:51,578 WAY TO TEST THE EFFICACY OF THIS 4809 03:18:51,578 --> 03:18:53,680 MOLECULE IN A SYNDROME THAT'S 4810 03:18:53,680 --> 03:18:55,315 CAUSED BY GAIN OF FUNCTION 4811 03:18:55,315 --> 03:18:57,284 ACTIVITY. 4812 03:18:57,284 --> 03:18:59,152 AND SO VERY QUICKLY, A TRIAL WAS 4813 03:18:59,152 --> 03:19:00,787 SET UP, AND YOU CAN SEE THE 4814 03:19:00,787 --> 03:19:02,222 TIMELINE, NOT TOO BAD, JUST 4815 03:19:02,222 --> 03:19:04,958 ABOUT A YEAR AND A HALF FROM 4816 03:19:04,958 --> 03:19:06,627 DISCOVERY PUBLICATION TO 4817 03:19:06,627 --> 03:19:08,929 CLINICAL TRIAL START, AND THEN A 4818 03:19:08,929 --> 03:19:10,464 YEAR LATER, THERE WAS A POSITIVE 4819 03:19:10,464 --> 03:19:12,566 PROOF OF CONCEPT, WHICH YOU CAN 4820 03:19:12,566 --> 03:19:13,767 ACHIEVE VERY QUICKLY IN A RARE 4821 03:19:13,767 --> 03:19:15,969 DISEASE. 4822 03:19:15,969 --> 03:19:17,170 UNFORTUNATELY, THE BIGGER 4823 03:19:17,170 --> 03:19:19,139 AMBITIONS FOR THIS MOLECULE TO 4824 03:19:19,139 --> 03:19:22,776 TREAT SJOGREN'S DISEASE AND 4825 03:19:22,776 --> 03:19:24,278 RHEUMATOID ARTHRITIS ARE NOT 4826 03:19:24,278 --> 03:19:25,612 REALIZED, THE TRIAL RESULTS WERE 4827 03:19:25,612 --> 03:19:27,714 LARGELY NEGATIVE AND THERE WERE 4828 03:19:27,714 --> 03:19:29,316 SOME INTERESTING ADVERSE EVENTS 4829 03:19:29,316 --> 03:19:33,720 WHICH HAPPENED -- PATIENTS, 4830 03:19:33,720 --> 03:19:35,155 BUT -- AND THIS IS WHERE I THINK 4831 03:19:35,155 --> 03:19:37,424 IT'S ANOTHER LESSON IN A RARE 4832 03:19:37,424 --> 03:19:39,159 DISEASE ONLY POPULATION, THIS 4833 03:19:39,159 --> 03:19:43,497 MAY NOT BE AN APPROPRIATE DRUG 4834 03:19:43,497 --> 03:19:46,333 TARGET FOR LARGE PHARMA, EVEN 4835 03:19:46,333 --> 03:19:48,101 THOUGH NOVARTIS HAD DONE A LOT 4836 03:19:48,101 --> 03:19:50,404 WITH TREATING RARE INFLAMMATORY 4837 03:19:50,404 --> 03:19:52,272 SYNDROMES WITH IL-1 INHIBITION 4838 03:19:52,272 --> 03:19:54,374 WAS DECIDED TO OUTLICENSE, BUT 4839 03:19:54,374 --> 03:19:56,043 THAT IS ALSO A PATHWAY THAT CAN 4840 03:19:56,043 --> 03:19:58,111 HAPPEN, SO THIS WAS MOLECULES 4841 03:19:58,111 --> 03:20:01,014 OUTLICENSED TO AN ORPHAN DRUG 4842 03:20:01,014 --> 03:20:02,950 COMPANY BUT OUR GROUP ACTUALLY 4843 03:20:02,950 --> 03:20:04,384 CONTINUED THE PIVOTAL TRIAL 4844 03:20:04,384 --> 03:20:06,053 WHICH WAS THEN STARTED AND 4845 03:20:06,053 --> 03:20:09,056 APPROVAL WAS GRANTED JUST LAST 4846 03:20:09,056 --> 03:20:09,489 YEAR. 4847 03:20:09,489 --> 03:20:12,626 I THINK SOME OF THE KEY FEATURES 4848 03:20:12,626 --> 03:20:14,394 THAT MADE THIS A REALLY 4849 03:20:14,394 --> 03:20:16,396 SUCCESSFUL PARTNERSHIP WERE THAT 4850 03:20:16,396 --> 03:20:18,899 NIAID AND MIKE AND OTHERS WERE 4851 03:20:18,899 --> 03:20:23,503 VERY OPEN TO PARTNERING, AND THE 4852 03:20:23,503 --> 03:20:24,371 TECH TRANSFER OFFICE WAS REALLY, 4853 03:20:24,371 --> 03:20:26,807 I THINK, GREAT AND EVEN IN 4854 03:20:26,807 --> 03:20:28,041 BENDING THE TYPE OF CLINICAL 4855 03:20:28,041 --> 03:20:30,210 TRIAL AGREEMENT WHICH IS NOT 4856 03:20:30,210 --> 03:20:31,945 FRIENDLY AND WE CAN TALK ABOUT 4857 03:20:31,945 --> 03:20:35,482 THAT IN THE Q & A, TO INDUSTRY 4858 03:20:35,482 --> 03:20:36,450 PARTNERSHIPS, BUT IT WORKED AND 4859 03:20:36,450 --> 03:20:38,118 MOST OF THE DATA, ABOUT HALF THE 4860 03:20:38,118 --> 03:20:39,519 PATIENTS IN THE PIVOTAL TRIAL 4861 03:20:39,519 --> 03:20:42,089 WERE AT NIH, AND THEN -- SO I 4862 03:20:42,089 --> 03:20:43,490 THINK IT'S A GREAT STORY. 4863 03:20:43,490 --> 03:20:45,359 VERY RARELY DO YOU GO 10 YEARS 4864 03:20:45,359 --> 03:20:46,593 FROM DISCOVERY OF A DISEASE TO 4865 03:20:46,593 --> 03:20:48,261 AN FDA-APPROVED THERAPY, BUT 4866 03:20:48,261 --> 03:20:50,964 THIS REALLY WAS A GREAT SUCCESS 4867 03:20:50,964 --> 03:20:53,266 IN THAT WAY. 4868 03:20:53,266 --> 03:20:55,268 SO JUST TO WRAP UP, I THINK I 4869 03:20:55,268 --> 03:21:00,774 WANTED TO SAY SOME POINTS AND TO 4870 03:21:00,774 --> 03:21:01,842 JUST KIND OF LEAVE FOR THE 4871 03:21:01,842 --> 03:21:02,776 DISCUSSION, BUT I THINK WHERE 4872 03:21:02,776 --> 03:21:04,511 THINGS CAN GO RIGHT AS WAS SEEN 4873 03:21:04,511 --> 03:21:06,046 THERE, AND I HEARD SOME GREAT 4874 03:21:06,046 --> 03:21:07,447 STORIES EARLIER IN THE DAY, AND 4875 03:21:07,447 --> 03:21:09,483 I THINK MANY OF YOU ARE AWARE, 4876 03:21:09,483 --> 03:21:10,550 THE PARTNER IN THE COMPANY NEEDS 4877 03:21:10,550 --> 03:21:13,620 TO HAVE THE SAME GOAL. 4878 03:21:13,620 --> 03:21:15,155 THAT HAS TO BE REALLY SPELLED 4879 03:21:15,155 --> 03:21:17,024 OUT, IT CAN'T JUST BE A KIND OF 4880 03:21:17,024 --> 03:21:18,225 VAGUE THING, IT HAS TO BE 4881 03:21:18,225 --> 03:21:19,493 SPELLED OUT AND ALSO THE DETAILS 4882 03:21:19,493 --> 03:21:22,629 OF IP PUBLICATION STRATEGY MUST 4883 03:21:22,629 --> 03:21:23,830 BE SPELLED OUT UP FRONT. 4884 03:21:23,830 --> 03:21:26,700 IF THE ACADEMIC PARTNER HAS IP 4885 03:21:26,700 --> 03:21:28,035 AT STAKE, WHICH WASN'T THE CASE 4886 03:21:28,035 --> 03:21:31,004 HERE, THAT CAN BE BETTER 4887 03:21:31,004 --> 03:21:31,972 ACCOMPLISHED POTENTIALLY WITH 4888 03:21:31,972 --> 03:21:33,774 BUSINESS DEVELOPMENT AS A 4889 03:21:33,774 --> 03:21:34,975 SPINOFF COMPANY AND THAT IS THE 4890 03:21:34,975 --> 03:21:35,809 PARTICULAR CHALLENGE OF NIH THAT 4891 03:21:35,809 --> 03:21:37,344 IS DIFFICULT TO DO IN THE 4892 03:21:37,344 --> 03:21:40,280 CURRENT FRAMEWORK. 4893 03:21:40,280 --> 03:21:41,815 IT ALSO REALLY NEEDS SCIENTIST 4894 03:21:41,815 --> 03:21:42,883 CHAMPIONS ON BOTH SIDES. 4895 03:21:42,883 --> 03:21:44,651 I'VE BEEN INVOLVED IN A NUMBER 4896 03:21:44,651 --> 03:21:46,186 OF BILATERAL CLAB WRAITIONS AND 4897 03:21:46,186 --> 03:21:47,888 BECAUSE THERE'S NO ARMY OF 4898 03:21:47,888 --> 03:21:49,356 PARTNERING BUSINESS PEOPLE TO 4899 03:21:49,356 --> 03:21:51,792 HELP, IT REALLY HAS TO BE DRIVEN 4900 03:21:51,792 --> 03:21:54,995 BY THE SCIENTISTS WORKING WITH 4901 03:21:54,995 --> 03:21:57,264 THE TECH -- OFFICE TO GET A 4902 03:21:57,264 --> 03:22:00,600 PARTNERSHIP SIGNED AND ALSO FOR 4903 03:22:00,600 --> 03:22:01,234 FOLLOW-UP OF THE RESULTS. 4904 03:22:01,234 --> 03:22:03,103 THERE IS THIS ISSUE AS WAS 4905 03:22:03,103 --> 03:22:04,871 DISCUSSED EARLIER IN THIS 4906 03:22:04,871 --> 03:22:05,972 MEETING, YOU SHOULD DEFINITELY 4907 03:22:05,972 --> 03:22:08,542 REACH OUT TO BIOTECH AND PHARMA 4908 03:22:08,542 --> 03:22:12,145 IF YOU WANT TO USE A DRUG FOR 4909 03:22:12,145 --> 03:22:14,314 AN -- BUT THAT CAN BE A PROBLEM, 4910 03:22:14,314 --> 03:22:15,215 ESPECIALLY DEPENDING ON THE 4911 03:22:15,215 --> 03:22:17,451 STAGE OF DEVELOPMENT, IF IT IN 4912 03:22:17,451 --> 03:22:21,354 SENSITIVE STAGES, TYPICALLY 4913 03:22:21,354 --> 03:22:23,256 PHASE THREE IS THE HARDEST AND 4914 03:22:23,256 --> 03:22:24,658 TYPICALLY UP TO EACH COMPANY, 4915 03:22:24,658 --> 03:22:28,595 EACH CIRCUMSTA CIRCUMSTANCE, ANE 4916 03:22:28,595 --> 03:22:32,499 IP CAN BE AN ISSUE AS ONE OF THE 4917 03:22:32,499 --> 03:22:33,867 NIAMS COLLABORATIONS WE WERE 4918 03:22:33,867 --> 03:22:37,270 INVOLVED WITH. HOWEVER, 4919 03:22:37,270 --> 03:22:38,405 PUBLICATIONS ARE NOT AN ISSUE. 4920 03:22:38,405 --> 03:22:40,273 ONCE YOU HAVE A TRIAL, FIRST OF 4921 03:22:40,273 --> 03:22:42,008 ALL, IT HAS TO BE PUBLIC, AND 4922 03:22:42,008 --> 03:22:43,210 EVERYBODY REALLY DOES WANT TO 4923 03:22:43,210 --> 03:22:45,312 PUBLISH THAT, WHETHER 4924 03:22:45,312 --> 03:22:46,179 DEVELOPMENT GOES ON OR NOT. 4925 03:22:46,179 --> 03:22:48,949 SO THAT'S NOT A LIMITATION. 4926 03:22:48,949 --> 03:22:53,487 IN A LIN C CLINICAL STATE YOUR . 4927 03:22:53,487 --> 03:22:55,322 WHERE PUBLICATIONS ARE LIMITED 4928 03:22:55,322 --> 03:22:59,259 IS IN THE CLINICAL PHASE. 4929 03:22:59,259 --> 03:23:00,927 -- DID SHARE THIS FEELING THAT 4930 03:23:00,927 --> 03:23:02,562 NIH IS JUST TOO TOUGH TO 4931 03:23:02,562 --> 03:23:04,264 COLLABORATE WITH, THE IRP, AND 4932 03:23:04,264 --> 03:23:05,565 THE TECH TRANSFER MODEL, THE 4933 03:23:05,565 --> 03:23:07,667 PAYMENT ISSUE OF HOW CRADAs 4934 03:23:07,667 --> 03:23:08,702 ARE FUNDED IS VERY DIFFERENT 4935 03:23:08,702 --> 03:23:09,402 THAN ANY OTHER PLACE IN THE 4936 03:23:09,402 --> 03:23:09,870 WORLD. 4937 03:23:09,870 --> 03:23:11,938 THAT IS MORE RESTRICTIVE. 4938 03:23:11,938 --> 03:23:13,707 THE BLOCK GRANT IS MUCH -- IS 4939 03:23:13,707 --> 03:23:16,309 UNUSUAL COMPARED TO A 4940 03:23:16,309 --> 03:23:18,545 PER-PATIENT FEES THAT ARE 4941 03:23:18,545 --> 03:23:21,314 STANDARD EVERY EVERYWHERE ELSE E 4942 03:23:21,314 --> 03:23:24,084 WORLD FOR CLINICAL 4943 03:23:24,084 --> 03:23:25,252 COLLABORATIONS BUT IT CAN BE 4944 03:23:25,252 --> 03:23:25,819 DONE. 4945 03:23:25,819 --> 03:23:28,522 IT HAPPENS WE HAVE A GREAT 4946 03:23:28,522 --> 03:23:37,831 COLLABORATION, OUR GROUP, WITH 4947 03:23:37,831 --> 03:23:41,234 BIBI -- WE'RE DOING ANKYLOSING 4948 03:23:41,234 --> 03:23:43,236 SPONDYLITIS WORK, AND AT A 4949 03:23:43,236 --> 03:23:44,271 CONSORTIUM LEVEL, THAT'S ALSO 4950 03:23:44,271 --> 03:23:44,604 POSSIBLE. 4951 03:23:44,604 --> 03:23:45,672 SO I THINK EVERYTHING IS 4952 03:23:45,672 --> 03:23:47,707 POSSIBLE BUT THERE ARE SPECIFIC 4953 03:23:47,707 --> 03:23:49,576 ISSUES WITHIN NIH THAT MAKE IT 4954 03:23:49,576 --> 03:23:50,811 MORE DIFFICULT THAT NEED TO BE 4955 03:23:50,811 --> 03:23:52,579 WORKED THROUGH. 4956 03:23:52,579 --> 03:23:54,014 SO OVERVIEW HOPEFULLY THAT WAS 4957 03:23:54,014 --> 03:23:55,615 HELPFUL AS GIVING SOME OF MY 4958 03:23:55,615 --> 03:23:57,317 EXPERIENCES AND I'LL PASS IT 4959 03:23:57,317 --> 03:23:57,517 BACK. 4960 03:23:57,517 --> 03:23:58,418 >> THANK YOU SO MUCH, RICHARD. 4961 03:23:58,418 --> 03:24:02,255 THAT WAS VERY INSIGHTFUL AND 4962 03:24:02,255 --> 03:24:04,257 YOUR UNIQUE PERSPECTIVE OF BOTH 4963 03:24:04,257 --> 03:24:05,125 INSIDE AND OUTSIDE. 4964 03:24:05,125 --> 03:24:06,927 SO WE ARE NOW GOING TO MOVE ON 4965 03:24:06,927 --> 03:24:08,428 TO OUR NEXT SPEAKER, BUT BEFORE 4966 03:24:08,428 --> 03:24:10,630 I DO THAT, I JUST WANTED TO 4967 03:24:10,630 --> 03:24:15,101 REMIND EVERYONE THAT THE LIVE 4968 03:24:15,101 --> 03:24:15,969 INTERACTION CHAT IS SORT OF A 4969 03:24:15,969 --> 03:24:18,138 TEAL BAR ACROSS YOUR SCREEN. 4970 03:24:18,138 --> 03:24:20,540 PLEASE POST YOUR QUESTIONS 4971 03:24:20,540 --> 03:24:22,042 THERE, EITHER FOR -- IN GENERAL 4972 03:24:22,042 --> 03:24:24,578 FOR ALL OF THE PANELISTS OR ANY 4973 03:24:24,578 --> 03:24:25,712 SPECIFIC QUESTIONS FOR RICHARD 4974 03:24:25,712 --> 03:24:27,180 OR ALL THE REST OF THE PANELISTS 4975 03:24:27,180 --> 03:24:28,815 WHO ARE COMING AFTER HIM, AND WE 4976 03:24:28,815 --> 03:24:29,816 WILL GET TO YOUR QUESTIONS AFTER 4977 03:24:29,816 --> 03:24:30,116 THAT. 4978 03:24:30,116 --> 03:24:37,991 WITH THAT, I WILL NOW ASK DR 4979 03:24:37,991 --> 03:24:47,868 DR. SEAN AGBOR TO GO AHEAD. 4980 03:24:47,868 --> 03:24:52,239 >> LET ME SEE IF I CAN GIVE YOU 4981 03:24:52,239 --> 03:24:55,008 A PERSPECTIVE FOR A TENURE TRACK 4982 03:24:55,008 --> 03:24:55,976 INVESTIGATOR WITHIN THE NIH, 4983 03:24:55,976 --> 03:24:56,543 DEVELOPING THINGS LIKE WHAT 4984 03:24:56,543 --> 03:24:57,644 WE'RE DOING IN THE LAB THAT 4985 03:24:57,644 --> 03:24:59,946 COULD BE BROUGHT TO PATIENTS AND 4986 03:24:59,946 --> 03:25:01,047 SOME OF THE CHALLENGES THAT 4987 03:25:01,047 --> 03:25:03,049 WE'RE FACING WITH THAT. 4988 03:25:03,049 --> 03:25:05,552 I'LL TALK A LITTLE BIT ABOUT 4989 03:25:05,552 --> 03:25:06,820 CELL FREE DNA FOR EARLY 4990 03:25:06,820 --> 03:25:08,521 DETECTION OF DISEASE, TREATMENT 4991 03:25:08,521 --> 03:25:13,560 EFFECT, OR TISSUE INJURY. 4992 03:25:13,560 --> 03:25:14,961 SO WHAT ARE CELL FREE DNA? 4993 03:25:14,961 --> 03:25:16,196 JUST AN OVERVIEW. 4994 03:25:16,196 --> 03:25:20,166 WHEN CELLS IN THE BODY DIE OR GO 4995 03:25:20,166 --> 03:25:21,201 THROUGH DIFFERENT PROCESSES, 4996 03:25:21,201 --> 03:25:22,535 THEY ARE RELEASED, THEIR 4997 03:25:22,535 --> 03:25:23,203 CONTENTS. 4998 03:25:23,203 --> 03:25:25,071 SOME OF THAT CONTENT END UP IN 4999 03:25:25,071 --> 03:25:26,506 YOUR SICK LAITION OR IN YOUR 5000 03:25:26,506 --> 03:25:26,873 BLOOD. 5001 03:25:26,873 --> 03:25:29,676 PART OF THAT CONTENT OF THE CELL 5002 03:25:29,676 --> 03:25:32,145 IS DNA, SO THAT CELL-FREE DNA, 5003 03:25:32,145 --> 03:25:34,848 THAT'S DNA THAT'S OUT OF A CELL, 5004 03:25:34,848 --> 03:25:36,416 CIRCULATING IN BLOOD, OR IT 5005 03:25:36,416 --> 03:25:38,184 COULD BE IN OTHER BIOLOGIC 5006 03:25:38,184 --> 03:25:38,718 FLUIDS. 5007 03:25:38,718 --> 03:25:41,021 IT IS REALLY QUITE ABUNDANT IN 5008 03:25:41,021 --> 03:25:41,588 BLOOD. 5009 03:25:41,588 --> 03:25:43,323 IN HEALTHY PATIENTS, IT CAN HAVE 5010 03:25:43,323 --> 03:25:47,093 UP TO $10 BILLION, WHICH SOURCE 5011 03:25:47,093 --> 03:25:49,062 OF BIOMOLECULES, SO WE STARTED 5012 03:25:49,062 --> 03:25:50,730 OUT TO SAY BIOMARKER. 5013 03:25:50,730 --> 03:25:52,499 AND WE'VE DEVELOPED SOME NOVEL 5014 03:25:52,499 --> 03:25:55,168 APPROACHES IN WHICH A VIAL OF 5015 03:25:55,168 --> 03:25:57,637 BLOOD, YOU CAN EXTRACT PLASMA 5016 03:25:57,637 --> 03:26:00,140 FROM THAT AND WITH THAT, YOU CAN 5017 03:26:00,140 --> 03:26:03,243 THEN TARGET TISSUE-SPECIFIC DNA 5018 03:26:03,243 --> 03:26:04,878 SIGNATURES LIKE EPIGENETIC 5019 03:26:04,878 --> 03:26:07,013 FINGERPRINTS THAT ARE PRESERVED 5020 03:26:07,013 --> 03:26:09,783 ON CELL-FREE DNA AS IT LEAVES 5021 03:26:09,783 --> 03:26:12,585 THE CELL, AND YOU CAN THEN TEASE 5022 03:26:12,585 --> 03:26:15,789 OUT WHICH TISSUES IN THE BODY 5023 03:26:15,789 --> 03:26:18,491 ARE UNDERGOING INJURY PROVIDING 5024 03:26:18,491 --> 03:26:20,293 A WHOLE BODY MOLECULAR INJURY 5025 03:26:20,293 --> 03:26:21,361 SCAN. 5026 03:26:21,361 --> 03:26:22,796 I'LL SHOW YOU A FEW EXAMPLES AND 5027 03:26:22,796 --> 03:26:26,533 THEN I'LL GO TO SOME STUDIES. 5028 03:26:26,533 --> 03:26:29,803 IMAGINE THAT THESE ARE TWO 5029 03:26:29,803 --> 03:26:30,603 PATIENTS -- NOT IMAGINE, THESE 5030 03:26:30,603 --> 03:26:32,105 ARE INDEED TWO PATIENTS WITH 5031 03:26:32,105 --> 03:26:33,006 COVID-19 WHO DIED. 5032 03:26:33,006 --> 03:26:35,642 IF YOU LOOK AT THESE PATIENTS, 5033 03:26:35,642 --> 03:26:39,245 THE CELL FREE DNA IS HIGH IN THE 5034 03:26:39,245 --> 03:26:41,114 EARLY TIME OF THEIR 5035 03:26:41,114 --> 03:26:42,549 HOSPITALIZATION, THE LEVELS ARE 5036 03:26:42,549 --> 03:26:44,451 HIGH, THE LEVELS DECREASE OVER 5037 03:26:44,451 --> 03:26:45,852 TIME AS THESE PATIENTS ARE 5038 03:26:45,852 --> 03:26:47,387 TREATED. 5039 03:26:47,387 --> 03:26:49,823 UNFORTUNATELY, BETWEEN THE 10 5040 03:26:49,823 --> 03:26:51,024 AND DAY 14, THESE PATIENTS GO 5041 03:26:51,024 --> 03:26:52,926 INTO A SECOND PHASE OF COVID 5042 03:26:52,926 --> 03:26:55,095 THAT WE CALL THE INFLAMMATORY 5043 03:26:55,095 --> 03:27:01,901 PHASE OF COVID. 5044 03:27:01,901 --> 03:27:05,839 EXPONENTIAL RISE IN THEIR DNA 5045 03:27:05,839 --> 03:27:06,773 UNTIL UNFORTUNATELY THESE 5046 03:27:06,773 --> 03:27:07,140 PATIENTS DIE. 5047 03:27:07,140 --> 03:27:08,708 WE PRESENTED DIFFERENT TISSUE 5048 03:27:08,708 --> 03:27:09,709 TYPES THAT'S BEEN INJURED IN 5049 03:27:09,709 --> 03:27:12,045 THESE PATIENTS OVER TIME. 5050 03:27:12,045 --> 03:27:14,948 COMPARE THAT THEN WITH THE 5051 03:27:14,948 --> 03:27:16,716 FOLLOWING TWO PATIENTS WITH 5052 03:27:16,716 --> 03:27:19,786 COVID-19 WHO IN THIS CASE 5053 03:27:19,786 --> 03:27:20,353 SURVIVED. 5054 03:27:20,353 --> 03:27:21,988 IF YOU LOOK AGAIN, AT THE TIME 5055 03:27:21,988 --> 03:27:23,757 OF ADMISSION, THEIR CELL-FREE 5056 03:27:23,757 --> 03:27:25,658 DNA IS HIGH BUT NOT AS HIGH AS 5057 03:27:25,658 --> 03:27:28,495 THE PATIENT WHO DIED. 5058 03:27:28,495 --> 03:27:30,363 THE TRENDS OF THEIR CELL FREE 5059 03:27:30,363 --> 03:27:33,099 DNA ALSO DIFFERS, AND THE TISSUE 5060 03:27:33,099 --> 03:27:34,734 TYPES PRODUCED IN THEIR 5061 03:27:34,734 --> 03:27:37,137 CELL-FREE DNA OVERTIME ALSO 5062 03:27:37,137 --> 03:27:38,238 DIFFERS FROM THE PATIENTS WHO 5063 03:27:38,238 --> 03:27:40,573 DIED. 5064 03:27:40,573 --> 03:27:42,442 SO USING THIS EXAMPLE OF 5065 03:27:42,442 --> 03:27:44,077 COVID-19, WE DEMONSTRATED THAT 5066 03:27:44,077 --> 03:27:47,781 WITH A VIAL OF BLOOD, YOU CAN 5067 03:27:47,781 --> 03:27:50,450 TEASE OUT A CERTAIN SET OF UP TO 5068 03:27:50,450 --> 03:27:52,986 42 DIFFERENT TISSUE TYPES, 5069 03:27:52,986 --> 03:27:53,987 WHETHER OR NOT THEY HAVE BEEN 5070 03:27:53,987 --> 03:27:55,522 INJURED AND IF SO, BY HOW MUCH, 5071 03:27:55,522 --> 03:27:58,158 AND WITH THAT INJURY, YOU SHOW 5072 03:27:58,158 --> 03:27:59,359 DIFFERENT TRENDS IN THE PATIENTS 5073 03:27:59,359 --> 03:28:01,561 WHO HAVE DIFFERENT OUTCOMES. 5074 03:28:01,561 --> 03:28:03,229 MORE IMPORTANTLY IS THE NEXT 5075 03:28:03,229 --> 03:28:06,099 SLIDE. 5076 03:28:06,099 --> 03:28:09,702 SO THIS ASSAY CAN PICK UP 5077 03:28:09,702 --> 03:28:10,703 DIFFERENT TISSUES. 5078 03:28:10,703 --> 03:28:12,605 THIS IS A GROUP OF RESEARCHERS, 5079 03:28:12,605 --> 03:28:14,507 PARTICULARLY FROM AROUND THE 5080 03:28:14,507 --> 03:28:16,342 WORLD, WHO HAVE HELPED TO BUILD 5081 03:28:16,342 --> 03:28:17,977 SOME OF THESE PLATFORMS, 5082 03:28:17,977 --> 03:28:20,847 INCLUDING OUR LAB AS WELL. 5083 03:28:20,847 --> 03:28:22,582 SO YOU CAN PICK UP INJURY FROM 5084 03:28:22,582 --> 03:28:24,884 DIFFERENT TISSUE TYPES USING 5085 03:28:24,884 --> 03:28:25,652 THIS. 5086 03:28:25,652 --> 03:28:28,221 NEXT POINT IS, YOU CAN PICK UP 5087 03:28:28,221 --> 03:28:31,591 INJURY SO MUCH MORE EARLY. 5088 03:28:31,591 --> 03:28:34,027 IF YOU IMAGINE THIS AS A LONG 5089 03:28:34,027 --> 03:28:36,729 TRANSPLANT COHORT HERE WHICH WE 5090 03:28:36,729 --> 03:28:38,531 STUDIED, AT TIME ZERO IS THE 5091 03:28:38,531 --> 03:28:42,135 TIME A PATIENT WITH LONG 5092 03:28:42,135 --> 03:28:43,236 TRANSPLANT DEVELOP REJECTION. 5093 03:28:43,236 --> 03:28:44,871 IF YOU LOOK AT CELL-FREE DNA AT 5094 03:28:44,871 --> 03:28:46,639 THAT TIME, THE LEVELS ARE HIGH. 5095 03:28:46,639 --> 03:28:50,577 BUT MORE IMPORTANTLY, TWO TO 5096 03:28:50,577 --> 03:28:52,011 FOUR MONTHS BEFORE THAT PATIENT 5097 03:28:52,011 --> 03:28:54,881 SHOWS ANY CLINICAL SIGNS OF 5098 03:28:54,881 --> 03:28:57,283 REJECTION, BEFORE THE BIOPSY OF 5099 03:28:57,283 --> 03:28:59,052 THAT PATIENT SHOWS SIGNS OF 5100 03:28:59,052 --> 03:29:00,753 REJECTION, THEY HAVE ELEVATIONS 5101 03:29:00,753 --> 03:29:02,856 IN CELL-FREE DNA, A TOOL FOR 5102 03:29:02,856 --> 03:29:04,757 EARLY DETECTION. 5103 03:29:04,757 --> 03:29:06,926 WE SHOWED THE SAME THING IN 5104 03:29:06,926 --> 03:29:08,962 HEART TRANSPLANTATION AS WELL. 5105 03:29:08,962 --> 03:29:12,065 AND WE'VE GONE FORTH TO SHOW THE 5106 03:29:12,065 --> 03:29:14,267 SAME PRINCIPLES IN DISEASES 5107 03:29:14,267 --> 03:29:16,569 BEYOND TRANSPLANTATION. 5108 03:29:16,569 --> 03:29:19,639 THIS IS SMALL SYSTEM 5109 03:29:19,639 --> 03:29:20,306 INFLAMMATORY SYNDROME IN 5110 03:29:20,306 --> 03:29:22,375 CHILDREN, WHICH IS AN 5111 03:29:22,375 --> 03:29:23,576 INFLAMMATORY SYNDROME THAT 5112 03:29:23,576 --> 03:29:24,911 CHILDREN GET AFTER THEY GET 5113 03:29:24,911 --> 03:29:27,313 COVID-19. 5114 03:29:27,313 --> 03:29:29,115 WE SHOWED THE SAME PRINCIPLE 5115 03:29:29,115 --> 03:29:30,950 THERE IN COVID-19 AS WELL. 5116 03:29:30,950 --> 03:29:34,254 IN TRANSPLANTS, IN 5117 03:29:34,254 --> 03:29:35,889 GRAFT-VERSUS-HOST DISEASE, 5118 03:29:35,889 --> 03:29:36,990 PULMONARY HYPERTENSION, AND 5119 03:29:36,990 --> 03:29:41,694 OTHER DISEASES AS WELL. 5120 03:29:41,694 --> 03:29:43,930 SO THE SECOND THING WE COULD 5121 03:29:43,930 --> 03:29:46,199 OFFER IN ADDITION TO THIS 5122 03:29:46,199 --> 03:29:49,169 BIOMARKER IS A -- PHENOTYPE 5123 03:29:49,169 --> 03:29:49,569 PATIENT COHORT. 5124 03:29:49,569 --> 03:29:51,804 WHAT WE HAVE IS A CONSORTIUM OF 5125 03:29:51,804 --> 03:29:55,241 CENTERS HERE IN THE DMV 5126 03:29:55,241 --> 03:29:55,975 MID-ATLANTIC REGION. 5127 03:29:55,975 --> 03:29:59,746 THIS IS AN NHLBI-SPONSORED 5128 03:29:59,746 --> 03:30:02,182 CONSORTIUM BETWEEN THE NHLBI AND 5129 03:30:02,182 --> 03:30:05,752 FIVE HOSPITALS WITHIN THIS AREA 5130 03:30:05,752 --> 03:30:07,754 THAT PERFORM HEART AND LUNG 5131 03:30:07,754 --> 03:30:08,154 TRANSPLANT. 5132 03:30:08,154 --> 03:30:10,723 WE HAVE A LARGE PHENOTYPE COHORT 5133 03:30:10,723 --> 03:30:12,692 FROM THIS AS WELL. 5134 03:30:12,692 --> 03:30:15,728 SO WITH THESE TWO, A BIOMARKER 5135 03:30:15,728 --> 03:30:17,764 AND THIS POPULATION, WE'VE BEEN 5136 03:30:17,764 --> 03:30:18,965 FORTUNATE TO HAVE SOME 5137 03:30:18,965 --> 03:30:22,602 PARTNERSHIPS WITH INDUSTRY. 5138 03:30:22,602 --> 03:30:25,972 THE FIRST WAS TRULY REMARKABLE 5139 03:30:25,972 --> 03:30:27,941 DURING COVID-19. 5140 03:30:27,941 --> 03:30:29,275 THIS IS AN EXAMPLE OF AN 5141 03:30:29,275 --> 03:30:33,146 INDUSTRY PARTNERSHIP WITH KDX 5142 03:30:33,146 --> 03:30:34,347 THAT WENT FROM BEGINNING TO 5143 03:30:34,347 --> 03:30:37,317 FINISH LINE VERY QUICKLY. 5144 03:30:37,317 --> 03:30:40,853 IN THIS STUDY WHICH WE'RE USING 5145 03:30:40,853 --> 03:30:42,055 CELL-FREE DNA TO MONITOR 5146 03:30:42,055 --> 03:30:43,923 PATIENTS INSTEAD OF BIOPSY, 5147 03:30:43,923 --> 03:30:47,093 WHICH IS THE GOLD STANDARD NOW, 5148 03:30:47,093 --> 03:30:48,228 THIS WAS ALSO WITHIN THE 5149 03:30:48,228 --> 03:30:50,029 COVID-19 PANDEMIC, AND THERE ARE 5150 03:30:50,029 --> 03:30:54,167 A LOT OF RULES WHERE THE NIH 5151 03:30:54,167 --> 03:30:57,070 TECH TRANSFER PEOPLE WORKED IN 5152 03:30:57,070 --> 03:30:59,339 MY VIEW REALLY SEAMLESSLY WITH 5153 03:30:59,339 --> 03:31:00,974 THE INDUSTRY PARTNERS TO REALLY 5154 03:31:00,974 --> 03:31:02,008 GET THIS TO WORK. 5155 03:31:02,008 --> 03:31:04,510 AND SO IT WAS A MULTICENTER 5156 03:31:04,510 --> 03:31:06,613 STUDY, FOUR CENTERS, AND WITHIN 5157 03:31:06,613 --> 03:31:08,147 ONLY 18 MONTHS, FROM THE 5158 03:31:08,147 --> 03:31:09,382 BEGINNING OF THE STUDY, THAT 5159 03:31:09,382 --> 03:31:13,319 PAPER WAS PUBLISHED, LOOKING AT 5160 03:31:13,319 --> 03:31:15,655 THE PUBLICATIONS THERE, AND THEY 5161 03:31:15,655 --> 03:31:17,991 STUDIED AND PROPOSED A 5162 03:31:17,991 --> 03:31:19,158 MONITORING PROTOCOL THAT HAS 5163 03:31:19,158 --> 03:31:21,327 BEEN ADOPTED BY MULTIPLE CENTERS 5164 03:31:21,327 --> 03:31:24,264 ACROSS THE U.S. AND CANADA. 5165 03:31:24,264 --> 03:31:26,199 SORE THE INDUSTRY PARTNERS 5166 03:31:26,199 --> 03:31:27,900 WORKED VERY QUICKLY, AND THEY 5167 03:31:27,900 --> 03:31:29,135 GET THE KIND OF RESOURCES THAT 5168 03:31:29,135 --> 03:31:32,405 WAS JUST AMAZING, SEAMLESSLY PUT 5169 03:31:32,405 --> 03:31:34,841 TOGETHER, TO BRING THIS TO 5170 03:31:34,841 --> 03:31:37,310 COMPLETION. 5171 03:31:37,310 --> 03:31:38,711 COMPARE THAT TO ANOTHER 5172 03:31:38,711 --> 03:31:39,946 PARTNERSHIP, THIS TIME WITH 5173 03:31:39,946 --> 03:31:41,247 DIFFERENT INDUSTRY, WE'RE TRYING 5174 03:31:41,247 --> 03:31:44,083 TO PROPOSE A RANDOMIZED CONTROL 5175 03:31:44,083 --> 03:31:47,920 TRIAL OF CELL-FREE DNA AGAINST 5176 03:31:47,920 --> 03:31:49,922 BIOPSY OR -- BIOPSY WHICH IS THE 5177 03:31:49,922 --> 03:31:51,991 CURRENT GOLD STANDARD TO LOOK 5178 03:31:51,991 --> 03:31:53,960 FOR TRANSPLANT REJECTION. 5179 03:31:53,960 --> 03:31:59,032 SO THAT STUDY DID NOT GO AS THE 5180 03:31:59,032 --> 03:32:03,403 PRIOR STUDY. 5181 03:32:03,403 --> 03:32:04,637 WE TOGETHER ARE WORKING WITH 5182 03:32:04,637 --> 03:32:05,338 INDUSTRY PARTNERS. 5183 03:32:05,338 --> 03:32:08,441 WE WROTE THE PROTOCOL WITH OUR 5184 03:32:08,441 --> 03:32:13,713 TECH TRANSFER ESTABLISHED SOME 5185 03:32:13,713 --> 03:32:16,482 CRADA OR SOME AGREEMENT WITH 5186 03:32:16,482 --> 03:32:18,451 INDUSTRY, THIS WAS SUPPOSED TO 5187 03:32:18,451 --> 03:32:21,421 BE -- I THINK A 25-CENTER STUDY 5188 03:32:21,421 --> 03:32:22,455 NATIONALLY AND IN CANADA. 5189 03:32:22,455 --> 03:32:24,324 WE CALLED A MEETING, 5190 03:32:24,324 --> 03:32:25,258 INVESTIGATORS FROM ALL THE 5191 03:32:25,258 --> 03:32:26,926 CENTERS THAT CAME TO THE 5192 03:32:26,926 --> 03:32:28,695 MEETING, A LOT OF ENTHUSIASM 5193 03:32:28,695 --> 03:32:29,495 BUILT IN THE FIELD. 5194 03:32:29,495 --> 03:32:33,966 WE HA HAD A PRELIMINARY MEETING 5195 03:32:33,966 --> 03:32:35,435 WITH THE FDA AND THEN 5196 03:32:35,435 --> 03:32:36,202 UNFORTUNATELY, THE COMPANY 5197 03:32:36,202 --> 03:32:37,970 PULLED THEIR FUNDS, AND THAT 5198 03:32:37,970 --> 03:32:39,605 STUDY DID NOT PROCEED TO 5199 03:32:39,605 --> 03:32:40,907 CONCLUSION. 5200 03:32:40,907 --> 03:32:46,446 SO THOSE ARE TWO EXAMPLES 5201 03:32:46,446 --> 03:32:49,382 THAT -- OUR INTERACTIONS WITH 5202 03:32:49,382 --> 03:32:50,016 INDUSTRY. 5203 03:32:50,016 --> 03:32:52,452 SO WHAT WE HAVE HERE, AND 5204 03:32:52,452 --> 03:32:54,921 ACTIVELY, I MEAN, I REALLY 5205 03:32:54,921 --> 03:32:56,022 APPRECIATE THE TALK TODAY FROM 5206 03:32:56,022 --> 03:32:58,658 OTHERS ABOUT THIS APPROACH TO 5207 03:32:58,658 --> 03:33:00,727 ACTIVELY SOUGHT OUT INDUSTRY, 5208 03:33:00,727 --> 03:33:02,061 HOPEFULLY WE CAN TALK TO TECH 5209 03:33:02,061 --> 03:33:03,196 TRANSFER AND EXPLORE THAT. 5210 03:33:03,196 --> 03:33:05,932 BECAUSE WHAT WE HAVE IS WE'RE 5211 03:33:05,932 --> 03:33:08,468 DEVELOPING BIOMARKERS THAT CAN 5212 03:33:08,468 --> 03:33:11,637 DO THINGS OR CAN BRING NEW LIGHT 5213 03:33:11,637 --> 03:33:12,705 INTO DIFFERENT DRUGS OR 5214 03:33:12,705 --> 03:33:15,908 DIFFERENT WAYS IN WHICH WE THINK 5215 03:33:15,908 --> 03:33:17,443 ABOUT DISEASE. 5216 03:33:17,443 --> 03:33:21,581 THESE BIOMARKER CELL FREE DARN S 5217 03:33:21,581 --> 03:33:23,383 ABLE TO PROVIDE A WHOLE 5218 03:33:23,383 --> 03:33:24,150 MOLECULAR INJURY SCAN. 5219 03:33:24,150 --> 03:33:25,184 NOW THE QUESTION IS, WHAT DO YOU 5220 03:33:25,184 --> 03:33:26,285 DO WITH THIS? 5221 03:33:26,285 --> 03:33:29,222 AS AN NIH LAB, TRYING TO DEVELOP 5222 03:33:29,222 --> 03:33:34,827 THESE METHODS THAT COULD COME 5223 03:33:34,827 --> 03:33:35,995 INTO PATIENTS VERY QUICKLY. 5224 03:33:35,995 --> 03:33:37,263 I THINK RELATIONSHIP WITH 5225 03:33:37,263 --> 03:33:38,264 INDUSTRIES WOULD BE CRITICAL IN 5226 03:33:38,264 --> 03:33:38,698 DOING THAT. 5227 03:33:38,698 --> 03:33:42,135 AND I WILL STOP HERE. 5228 03:33:42,135 --> 03:33:45,872 >> THANK YOU SO MUCH, DR. AGBOR, 5229 03:33:45,872 --> 03:33:47,874 FOR THAT VERY INTERESTING 5230 03:33:47,874 --> 03:33:49,876 PERSPECTIVE FROM THE INTRAMURAL 5231 03:33:49,876 --> 03:33:52,145 NIH PERSPECTIVE. 5232 03:33:52,145 --> 03:33:53,446 NOW WE'LL SWITCH BACK TO 5233 03:33:53,446 --> 03:33:59,252 INDUSTRY AND OUR NEXT SPEAKER IS 5234 03:33:59,252 --> 03:34:09,562 DR. PURUSHOTHAMAN. 5235 03:34:13,032 --> 03:34:13,833 PLEASE TAKE IT AWAY. 5236 03:34:13,833 --> 03:34:15,134 >> HELLO, EVERYONE. 5237 03:34:15,134 --> 03:34:16,068 THANK YOU AND GOOD AFTERNOON. 5238 03:34:16,068 --> 03:34:17,403 THANK YOU FOR BEING HERE FOR THE 5239 03:34:17,403 --> 03:34:18,337 PRESENTATION. 5240 03:34:18,337 --> 03:34:20,873 I HOPE EVERYONE CAN SEE THE 5241 03:34:20,873 --> 03:34:23,543 SCREEN. 5242 03:34:23,543 --> 03:34:28,548 SO LET ME START OFF, THANK YOU, 5243 03:34:28,548 --> 03:34:30,249 DR. HASNI AND NIH FOR ORGANIZING 5244 03:34:30,249 --> 03:34:31,851 THIS GREAT OPPORTUNITY. 5245 03:34:31,851 --> 03:34:33,252 EXCITED TO BE HERE. 5246 03:34:33,252 --> 03:34:41,527 SO I AM THE CEO OF PROGENTEC 5247 03:34:41,527 --> 03:34:41,861 DIAGNOSTICS. 5248 03:34:41,861 --> 03:34:47,600 SO A LITTLE BIT ABOUT PROGENTEC. 5249 03:34:47,600 --> 03:34:48,835 WE ARE A DIGITAL HEALTH COMPANY, 5250 03:34:48,835 --> 03:34:50,770 IN THE AUTOIMMUNE SPACE WHERE WE 5251 03:34:50,770 --> 03:34:53,940 ARE FOCUSED ON BRINGING TOGETHER 5252 03:34:53,940 --> 03:34:55,007 BIOLOGIC SIGNALS AS WELL AS 5253 03:34:55,007 --> 03:34:58,411 DIGITAL SIGNALS TOGETHER INTO AN 5254 03:34:58,411 --> 03:34:59,312 AI ENVIRONMENT AND COMBINING 5255 03:34:59,312 --> 03:35:01,080 THAT WITH VARIOUS INTERVENTIONS, 5256 03:35:01,080 --> 03:35:06,686 BOTH DIGITAL AS WELL AS VIRTUAL, 5257 03:35:06,686 --> 03:35:09,322 TO BRING ABOUT MEANINGFUL 5258 03:35:09,322 --> 03:35:10,723 DIFFERENCE TO PATIENTS. 5259 03:35:10,723 --> 03:35:11,757 OUR FIRST FORAY INTO THE SPACE 5260 03:35:11,757 --> 03:35:12,992 HAS BEEN IN LUPUS, WE'RE NOW 5261 03:35:12,992 --> 03:35:15,261 WORKING ON A FEW OTHER SIMILAR 5262 03:35:15,261 --> 03:35:15,828 CONDITIONS. 5263 03:35:15,828 --> 03:35:17,063 THE CHALLENGE HAS YOU CAN 5264 03:35:17,063 --> 03:35:21,234 IMAGINE IN THE AUTOIMMUNE WORLD 5265 03:35:21,234 --> 03:35:22,401 IS THAT MOST OF THE TREATMENT 5266 03:35:22,401 --> 03:35:23,870 PARTICULARLY FOR THE DISEASES WE 5267 03:35:23,870 --> 03:35:24,904 ARE TALKING ABOUT HERE, LUPUS, 5268 03:35:24,904 --> 03:35:26,572 YOU KNOW, THE TREEMENT AND 5269 03:35:26,572 --> 03:35:28,074 MANAGEMENT IS OFTEN VERY 5270 03:35:28,074 --> 03:35:29,108 REACTIVE. 5271 03:35:29,108 --> 03:35:31,110 SO OFTENTIMES, YOU KNOW, YOU 5272 03:35:31,110 --> 03:35:33,479 TREAT THESE PATIENTS ON 5273 03:35:33,479 --> 03:35:36,983 SYMPTOMATOLOGY, AND ALL OF THIS 5274 03:35:36,983 --> 03:35:38,784 LEADS TO POOR PATIENT OUTCOMES 5275 03:35:38,784 --> 03:35:40,419 AND POTENTIALLY ALSO QUITE A BIT 5276 03:35:40,419 --> 03:35:45,825 OF THE RESOURCES BEING USED UP 5277 03:35:45,825 --> 03:35:48,895 FOR SUBOPTIMAL OUT K OUTCOMES IE 5278 03:35:48,895 --> 03:35:49,228 PATIENTS. 5279 03:35:49,228 --> 03:35:50,696 SO OUR APPROACH HAS BEEN 5280 03:35:50,696 --> 03:35:51,964 SOMEWHAT UNIQUE AND WHAT WE TRY 5281 03:35:51,964 --> 03:35:56,369 TO DO HERE IS WE HAVE A 5282 03:35:56,369 --> 03:35:57,937 DATA-DRIVEN PLATFORM, WE BRING 5283 03:35:57,937 --> 03:36:02,975 TOGETHER PL -- WE USE SIGNALS TO 5284 03:36:02,975 --> 03:36:07,647 GIVE US THAT PREDICTIVE ABILITY 5285 03:36:07,647 --> 03:36:09,916 AND WE THEN USE DIGITAL AND 5286 03:36:09,916 --> 03:36:10,750 VIRTUAL INTERVENTIONS TO MAKE A 5287 03:36:10,750 --> 03:36:12,084 DIFFERENCE TO THESE PATIENTS. 5288 03:36:12,084 --> 03:36:13,386 ALL OF THIS COMES TOGETHER INTO 5289 03:36:13,386 --> 03:36:17,223 A PLATFORM THAT ALLOWS THE 5290 03:36:17,223 --> 03:36:19,292 PHYSICIAN TO KIND OF TAKE THIS 5291 03:36:19,292 --> 03:36:21,027 PATIENT THROUGH A MORE OF A 5292 03:36:21,027 --> 03:36:23,996 PROACTIVE CARE MANAGEMENT. 5293 03:36:23,996 --> 03:36:25,865 SO OUR INITIAL FORAY HAS BEEN 5294 03:36:25,865 --> 03:36:26,566 INTO LUPUS. 5295 03:36:26,566 --> 03:36:28,968 WE ARE ALSO WORKING ON MS AND A 5296 03:36:28,968 --> 03:36:34,273 FEW OTHER AUTOIMMUNE CONDITIONS. 5297 03:36:34,273 --> 03:36:36,976 NOW, TALKING ABOUT PARTNERSHIP 5298 03:36:36,976 --> 03:36:41,948 WITH NIH AS A SMALL COMPANY, 5299 03:36:41,948 --> 03:36:43,215 STARTUP COMPANY, WE HAVE BEEN 5300 03:36:43,215 --> 03:36:45,051 ENGAGED WITH NIH FOR QUITE SOME 5301 03:36:45,051 --> 03:36:47,853 TIME AND IT BEEN SOMEWHAT 5302 03:36:47,853 --> 03:36:50,823 CENTRAL TO OUR R & D EFFORTS IN 5303 03:36:50,823 --> 03:36:51,424 SOME WAY. 5304 03:36:51,424 --> 03:36:52,458 SO LOOKING AT MORE OF THE 5305 03:36:52,458 --> 03:36:53,726 EXTRAMURAL SIDE, WE HAVE BEEN, 5306 03:36:53,726 --> 03:36:55,261 YOU KNOW, VERY ACTIVELY INVOLVED 5307 03:36:55,261 --> 03:36:57,663 IN GETTING SBIR GRANT, ONE OF 5308 03:36:57,663 --> 03:37:00,366 OUR COMMERCIAL READINESS 5309 03:37:00,366 --> 03:37:01,767 PROGRAM, OUR GRANT IS CURRENTLY 5310 03:37:01,767 --> 03:37:05,638 BEING EVALUATED, NIH HAS BEEN 5311 03:37:05,638 --> 03:37:08,240 INSTRUMENTAL IN TAKING US TO 5312 03:37:08,240 --> 03:37:10,576 VARIOUS -- PARTICULAR TO THE BIO 5313 03:37:10,576 --> 03:37:11,911 CONFERENCE, ALLOWING US TO PITCH 5314 03:37:11,911 --> 03:37:14,013 TO INVESTORS WHO ALL OF THAT HAS 5315 03:37:14,013 --> 03:37:14,847 BEEN GOING ON. 5316 03:37:14,847 --> 03:37:16,782 BUT I THINK THE FOCUS HERE TODAY 5317 03:37:16,782 --> 03:37:19,852 IS ON THE INTRAMURAL SIDE, THE 5318 03:37:19,852 --> 03:37:21,454 COLLABORATION THAT WE HAVE BEEN 5319 03:37:21,454 --> 03:37:25,958 ABLE TO ESTABLISH WITH NIAMS. 5320 03:37:25,958 --> 03:37:28,561 SO THIS STARTED SOMETIME IN 2020 5321 03:37:28,561 --> 03:37:31,897 WITH DR. HASNI REACHING OUT TO 5322 03:37:31,897 --> 03:37:33,532 US AND BASED ON THAT, WE WERE 5323 03:37:33,532 --> 03:37:37,637 ABLE TO IDENTIFY AN OPPORTUNITY 5324 03:37:37,637 --> 03:37:39,105 AND REALLY WORK OUT THE DETAILS 5325 03:37:39,105 --> 03:37:40,539 FOR A COLLABORATIVE ARRANGEMENT, 5326 03:37:40,539 --> 03:37:41,474 AND SINCE THEN, WE HAVE 5327 03:37:41,474 --> 03:37:46,145 ESTABLISHED A CRADA AGREEMENT 5328 03:37:46,145 --> 03:37:47,613 LATE 2021, EARLY 2022, AND SINCE 5329 03:37:47,613 --> 03:37:51,417 THEN, WE HAVE BEEN CONTINUING 5330 03:37:51,417 --> 03:37:54,253 DISCUSSIONS IN VARIOUS ASPECTS, 5331 03:37:54,253 --> 03:37:55,621 EVERYTHING FROM AVAILABILITY OF 5332 03:37:55,621 --> 03:37:57,289 RESOURCES TO LOGISTICS AND A 5333 03:37:57,289 --> 03:38:01,260 NUMBER OF OTHER POTENTIAL ISSUES 5334 03:38:01,260 --> 03:38:02,561 BUT WE FEEL THAT THE PROJECT 5335 03:38:02,561 --> 03:38:11,570 THAT WE HAVE WORKED OUT WILL SEE 5336 03:38:11,570 --> 03:38:13,406 GOALS REALIZED BY THE END OF 5337 03:38:13,406 --> 03:38:14,106 THIS YEAR. 5338 03:38:14,106 --> 03:38:15,875 SO THE OVERALL STRUCTURE AND 5339 03:38:15,875 --> 03:38:18,010 FRAMEWORK WE AGREED TO WITH THE 5340 03:38:18,010 --> 03:38:21,313 GROUP ESSENTIALLY INVOLVED THE 5341 03:38:21,313 --> 03:38:25,017 COMPANY TAKING ON 100 LUPUS 5342 03:38:25,017 --> 03:38:27,486 PATIENTS FROM OUT OF THE NATURAL 5343 03:38:27,486 --> 03:38:30,089 HISTORY COHORT OF PATIENTS, AND 5344 03:38:30,089 --> 03:38:32,892 FOLLOWING THEM LONGITUDINALLY 5345 03:38:32,892 --> 03:38:34,660 OVER TIME AND DURING THIS TIME 5346 03:38:34,660 --> 03:38:35,294 COLLECTING BIOLOGIC SAMPLES SO 5347 03:38:35,294 --> 03:38:36,996 WE CAN LOOK AT BIOMARKERS OF 5348 03:38:36,996 --> 03:38:39,298 INTEREST TO US THAT WOULD 5349 03:38:39,298 --> 03:38:41,067 SUPPORT SOME OF THE TECHNOLOGIES 5350 03:38:41,067 --> 03:38:45,271 THAT WE HAVE DEVELOPED IN HOUSE. 5351 03:38:45,271 --> 03:38:49,575 IN ADDITION TO THAT, ALSO ON 5352 03:38:49,575 --> 03:38:51,210 ONBOARD THESE PATIENTS IN OUR 5353 03:38:51,210 --> 03:38:53,846 COMPREHENSIVE MANAGEMENT CARE 5354 03:38:53,846 --> 03:38:55,748 SOLUTION PROGRAM, UNDER THIS, 5355 03:38:55,748 --> 03:38:57,850 THESE PATIENTS ARE, YOU KNOW, 5356 03:38:57,850 --> 03:39:01,320 GIVEN SMALL DEVICES TO CAPTURE 5357 03:39:01,320 --> 03:39:05,458 PROs, SURVEYS, BIOMETRIC DANA 5358 03:39:05,458 --> 03:39:07,293 AND OTHER DATA COMPONENTS THAT 5359 03:39:07,293 --> 03:39:10,896 ARE PART OF THAT PROGRAM. 5360 03:39:10,896 --> 03:39:13,332 AND IN TERMS OF THE FRAMEWORK 5361 03:39:13,332 --> 03:39:16,402 THAT WAS AGREED ON TO PURSUE 5362 03:39:16,402 --> 03:39:19,605 THESE GOALS, THE NIH WAS 5363 03:39:19,605 --> 03:39:22,742 RESPONSIBLE UNDER THIS FRAMEWORK 5364 03:39:22,742 --> 03:39:25,144 TO IDENTIFY -- FROM OUT OF THE 5365 03:39:25,144 --> 03:39:28,681 COHORT INTO THE STUDY. 5366 03:39:28,681 --> 03:39:29,348 AND HELP 5367 03:39:29,348 --> 03:39:31,117 US COLLECT BIOLOGIC SAMPLES, 5368 03:39:31,117 --> 03:39:35,287 PATIENT D DATA, PATIENT-REPORTED 5369 03:39:35,287 --> 03:39:36,989 OUTCOMES AND OTHER DATA THAT IS 5370 03:39:36,989 --> 03:39:37,256 REQUIRED. 5371 03:39:37,256 --> 03:39:38,758 FROM OUR PERSPECTIVE, WE WERE 5372 03:39:38,758 --> 03:39:40,826 OBVIOUSLY GETTING THESE SAMPLES, 5373 03:39:40,826 --> 03:39:45,164 ANALYZING THEM AND COMING UP 5374 03:39:45,164 --> 03:39:48,000 WITH OUR PROPRIETARY TEST 5375 03:39:48,000 --> 03:39:49,568 INDICES THAT WERE PASSED -- 5376 03:39:49,568 --> 03:39:51,570 THEY'RE TO BE PASSED BACK TO THE 5377 03:39:51,570 --> 03:39:53,572 PHYSICIAN, AND IN ADDITION TO 5378 03:39:53,572 --> 03:39:56,909 THAT, THE SOFTWARE SUPPORT 5379 03:39:56,909 --> 03:39:58,043 DEVICES, EVERYTHING ELSE THAT'S 5380 03:39:58,043 --> 03:40:00,379 REQUIRED TO ONBOARD THEM ONTO 5381 03:40:00,379 --> 03:40:01,547 OUR COMPREHENSIVE MANAGEMENT 5382 03:40:01,547 --> 03:40:02,982 CARE SOLUTION. 5383 03:40:02,982 --> 03:40:04,416 AND IT GOES WITHOUT SAYING ALL 5384 03:40:04,416 --> 03:40:05,818 OF THE DATA COLLECTION 5385 03:40:05,818 --> 03:40:07,920 AGGREGATION ANALYSIS OF DIGITAL 5386 03:40:07,920 --> 03:40:09,622 AND BIOMETRIC DATA, ALL OF THIS, 5387 03:40:09,622 --> 03:40:11,724 THESE ARE ALSO COMPONENTS OF 5388 03:40:11,724 --> 03:40:14,527 THIS VERY INNOVATIVE 5389 03:40:14,527 --> 03:40:19,431 COLLABORATIVE FRAMEWORK. 5390 03:40:19,431 --> 03:40:22,168 SO LOOKING AT SOME KEY TAKEAWAYS 5391 03:40:22,168 --> 03:40:24,236 AND SOME GENERAL OBSERVATIONS 5392 03:40:24,236 --> 03:40:28,374 HERE, NOW, OBVIOUSLY THE NATURAL 5393 03:40:28,374 --> 03:40:32,211 HISTORY COHORT, THE LUPUS PHASE 5394 03:40:32,211 --> 03:40:33,479 IS A UNIQUE COLLABORATION 5395 03:40:33,479 --> 03:40:35,648 OPPORTUNITY FOR ANYONE DOING 5396 03:40:35,648 --> 03:40:36,849 RESEARCH WORK IN LUPUS. 5397 03:40:36,849 --> 03:40:38,450 SO WE FOUND THAT TO BE AN 5398 03:40:38,450 --> 03:40:41,487 EXTREMELY VALUABLE, YOU KNOW, 5399 03:40:41,487 --> 03:40:44,456 ASSET, AND WANTED TO, YOU KNOW, 5400 03:40:44,456 --> 03:40:48,494 AGAIN, THE FACT THAT IT HAS THE 5401 03:40:48,494 --> 03:40:50,696 LONGITUDINAL NATURE OF THAT IN 5402 03:40:50,696 --> 03:40:53,199 THE AVAILABILITY OF WELL 5403 03:40:53,199 --> 03:40:54,166 CHARACTERIZED PATIENT DATA, ALL 5404 03:40:54,166 --> 03:40:56,101 OF THOSE ARE OF IMMENSE VALUE TO 5405 03:40:56,101 --> 03:40:59,071 ANYONE DOING WORK IN THIS SPACE. 5406 03:40:59,071 --> 03:41:01,307 I THINK WHAT WE REALLY 5407 03:41:01,307 --> 03:41:03,809 APPRECIATE HERE IS THE FACT THAT 5408 03:41:03,809 --> 03:41:07,780 THE SOLUTION THAT WE HAVE IS 5409 03:41:07,780 --> 03:41:11,383 SOMEWHAT A NOVEL AND ALSO IT'S 5410 03:41:11,383 --> 03:41:13,853 GOT SOME VERY UNIQUE PARAMETERS, 5411 03:41:13,853 --> 03:41:15,654 COMBINING DIGITAL AND BIOMARKER 5412 03:41:15,654 --> 03:41:17,156 SIGNALS SO PROVIDE DEEPER 5413 03:41:17,156 --> 03:41:18,791 INSIGHTS TO A PHYSICIAN MANAGING 5414 03:41:18,791 --> 03:41:21,660 THESE CONDITIONS, AND MAKING AN 5415 03:41:21,660 --> 03:41:23,429 IMPACT, YOU KNOW, WHEN YOU THINK 5416 03:41:23,429 --> 03:41:24,797 IN TERMS OF IMPLEMENTING 5417 03:41:24,797 --> 03:41:28,500 SOMETHING LIKE THIS, IT ALWAYS 5418 03:41:28,500 --> 03:41:30,169 POSES SOME CHALLENGES. 5419 03:41:30,169 --> 03:41:31,570 BUT WE WERE PARTICULARLY 5420 03:41:31,570 --> 03:41:33,939 IMPRESSED WITH NIH'S WILLINGNESS 5421 03:41:33,939 --> 03:41:35,507 TO ENTERTAIN THESE KINDS OF 5422 03:41:35,507 --> 03:41:40,179 APPROACHES AND REALLY SUPPORT US 5423 03:41:40,179 --> 03:41:41,180 AND PROVIDE THAT OPPORTUNITY SO 5424 03:41:41,180 --> 03:41:42,014 THAT WAS SOMETHING THAT WE 5425 03:41:42,014 --> 03:41:43,215 THOUGHT WAS VERY, VERY 5426 03:41:43,215 --> 03:41:48,020 ENCOURAGING FOR US AS A WELL. 5427 03:41:48,020 --> 03:41:50,155 IN TERMS OF SOME OF THE -- I 5428 03:41:50,155 --> 03:41:50,756 WON'T SAY CHALLENGES BUT THE 5429 03:41:50,756 --> 03:41:52,291 FACT THAT IT TAKES US LONGER TO 5430 03:41:52,291 --> 03:41:55,227 IMPLEMENT SOMETHING LIKE THIS, 5431 03:41:55,227 --> 03:41:55,828 OBVIOUSLY THE FACT THAT I 5432 03:41:55,828 --> 03:41:57,463 MENTIONED BEFORE THE NOVEL 5433 03:41:57,463 --> 03:42:00,099 APPROACHES, YOU KNOW, AND 5434 03:42:00,099 --> 03:42:02,167 OBVIOUSLY THAT REQUIRES -- THAT 5435 03:42:02,167 --> 03:42:03,969 POSES ITS OWN UNIQUE CHALLENGES, 5436 03:42:03,969 --> 03:42:06,238 REQUIRES DECISION-MAKING, 5437 03:42:06,238 --> 03:42:09,408 BECOMES -- IT INVOLVES MULTIPLE 5438 03:42:09,408 --> 03:42:10,276 AGENCIES AND ALL OF THAT, SO 5439 03:42:10,276 --> 03:42:14,013 THERE ARE SOME CHALLENGES THAT 5440 03:42:14,013 --> 03:42:14,880 COME UP FROM THAT. 5441 03:42:14,880 --> 03:42:16,682 THE OTHER AREA, AND I THINK THIS 5442 03:42:16,682 --> 03:42:18,884 HAS BEEN TALKED ABOUT BEFORE, 5443 03:42:18,884 --> 03:42:20,986 BUT AS A SMALL COMPANY, A 5444 03:42:20,986 --> 03:42:23,956 STARTUP, WE ARE ALWAYS FACING, 5445 03:42:23,956 --> 03:42:27,726 YOU KNOW, FUNDING AND OTHER 5446 03:42:27,726 --> 03:42:29,261 ISSUES AND IN MOST OF THESE 5447 03:42:29,261 --> 03:42:30,996 STUDIES, WE ARE REQUIRED TO DRAW 5448 03:42:30,996 --> 03:42:34,900 ON OUR OWN CAPITAL IN MOST 5449 03:42:34,900 --> 03:42:36,101 CASES, INVESTMENT CAPITAL. 5450 03:42:36,101 --> 03:42:37,736 SO THIS WAS SOME OF THE THINGS 5451 03:42:37,736 --> 03:42:40,339 THAT WE AS A COMPANY FACE. 5452 03:42:40,339 --> 03:42:42,074 I JUST WANT TO KIND OF EMPHASIZE 5453 03:42:42,074 --> 03:42:46,011 THAT AS A SMALL COMPANY, THIS 5454 03:42:46,011 --> 03:42:48,380 BECOMES FURTHER ENHANCED AS A 5455 03:42:48,380 --> 03:42:51,917 BIGGER ISSUE FOR US. 5456 03:42:51,917 --> 03:42:55,955 OTHER AREAS OF INTEREST, FROM 5457 03:42:55,955 --> 03:42:57,222 PROGENTEC'S PERSPECTIVE, WE HAVE 5458 03:42:57,222 --> 03:42:58,958 BEEN LOOKING AT TWO OTHER AREAS 5459 03:42:58,958 --> 03:43:00,259 WHERE WE HAVE BEEN DOING QUITE A 5460 03:43:00,259 --> 03:43:05,731 BIT OF WORK, AND THESE ARE FROM 5461 03:43:05,731 --> 03:43:07,766 OUR PERSPECTIVE MANAGING LUPUS 5462 03:43:07,766 --> 03:43:10,436 PATIENTS, THESE ARE MAJOR 5463 03:43:10,436 --> 03:43:12,037 CHALLENGES AND HUGE UNMET NEEDS 5464 03:43:12,037 --> 03:43:12,571 IN THIS SPACE. 5465 03:43:12,571 --> 03:43:14,606 SO THE FIRST IS EARLY 5466 03:43:14,606 --> 03:43:15,474 CLASSIFICATION OF LUPUS 5467 03:43:15,474 --> 03:43:16,709 PATIENTS. 5468 03:43:16,709 --> 03:43:18,344 AND WE CURRENTLY HAVE A STUDY 5469 03:43:18,344 --> 03:43:20,579 THAT'S GOING ON WITH A HUNDRED 5470 03:43:20,579 --> 03:43:22,114 PATIENT, BUT WE ARE OBVIOUSLY 5471 03:43:22,114 --> 03:43:24,216 LOOKING FOR OTHER WAYS TO WORK 5472 03:43:24,216 --> 03:43:27,753 WITHIN NIH OR OTHER AGENCIES AND 5473 03:43:27,753 --> 03:43:30,055 OTHER INSTITUTIONS TO SEE WHAT 5474 03:43:30,055 --> 03:43:32,124 WE CAN DO TO FURTHER VALIDATE 5475 03:43:32,124 --> 03:43:35,627 THESE TECHNOLOGIES. 5476 03:43:35,627 --> 03:43:37,396 SIMILARLY, THE OTHER AREA OF 5477 03:43:37,396 --> 03:43:40,966 INTEREST IS LUPUS NEPHRITIS, A 5478 03:43:40,966 --> 03:43:41,967 HUGE UNMET NEED WHERE THERE'S A 5479 03:43:41,967 --> 03:43:43,869 LOT OF WORK THAT IS YET TO BEGUN 5480 03:43:43,869 --> 03:43:46,758 AND WE BELIEVE THAT WE HAVE A SOLUTION 5481 03:43:46,758 --> 03:43:48,259 THAT COULD PROVIDE ANSWERS, AND 5482 03:43:48,259 --> 03:43:49,994 WE'RE WORKING ON THAT. 5483 03:43:49,994 --> 03:43:51,963 AGAIN, I THINK THERE'S ALWAYS 5484 03:43:51,963 --> 03:43:56,234 ROOM FOR FURTHER -- WORKING 5485 03:43:56,234 --> 03:43:59,270 CLOSELY WITH NIH AND OTHER 5486 03:43:59,270 --> 03:44:00,371 INSTITUTIONS ON TAKING SOME OF 5487 03:44:00,371 --> 03:44:02,340 THESE FORWARD. 5488 03:44:02,340 --> 03:44:04,575 BY WAY OF GENERAL SUGGESTIONS, I 5489 03:44:04,575 --> 03:44:06,110 THINK THIS CONFERENCE ITSELF IS 5490 03:44:06,110 --> 03:44:08,212 A GREAT WAY TO GET PEOPLE AROUND 5491 03:44:08,212 --> 03:44:09,313 AND DISCUSS SOME OF THESE 5492 03:44:09,313 --> 03:44:09,747 ISSUES. 5493 03:44:09,747 --> 03:44:11,616 I THINK IT WOULD BE GREAT IF WE 5494 03:44:11,616 --> 03:44:15,053 CAN HAVE SOMETHING LIKE THIS ON 5495 03:44:15,053 --> 03:44:16,287 A PERIODIC BASIS. 5496 03:44:16,287 --> 03:44:17,922 I'M NOT SURE IF THERE IS ALREADY 5497 03:44:17,922 --> 03:44:19,223 SUCH AN INSTITUTION, BUT SOME 5498 03:44:19,223 --> 03:44:22,360 KIND OF AN NIH INDUSTRY 5499 03:44:22,360 --> 03:44:23,327 COLLABORATORY GROUP THAT CAN 5500 03:44:23,327 --> 03:44:26,230 FURTHER SOME OF THESE OBJECTIVES 5501 03:44:26,230 --> 03:44:27,165 AND GOALS WOULD BE ANOTHER 5502 03:44:27,165 --> 03:44:28,800 SUGGESTION THAT WE WOULD HAVE. 5503 03:44:28,800 --> 03:44:32,737 AND WITH THAT, I WANT TO JUST 5504 03:44:32,737 --> 03:44:34,505 STOP HERE, THANK EVERYBODY, AND 5505 03:44:34,505 --> 03:44:39,911 HAPPY TO TAKE ANY QUESTIONS, AND 5506 03:44:39,911 --> 03:44:40,578 DR. HASNI, I'M HANDING IT BACK 5507 03:44:40,578 --> 03:44:41,012 TO YOU. 5508 03:44:41,012 --> 03:44:44,048 >> THANK YOU SO MUCH. 5509 03:44:44,048 --> 03:44:46,150 SO THAT WAS GREAT, AND AGAIN, 5510 03:44:46,150 --> 03:44:49,887 REMINDER IS THAT PLEASE PUT YOUR 5511 03:44:49,887 --> 03:44:51,923 QUESTIONS IN THE -- SORT OF THE 5512 03:44:51,923 --> 03:44:54,759 TEAL BAR ACROSS YOUR SCREEN FOR 5513 03:44:54,759 --> 03:44:57,261 THAT LIVE INTERACTION AND YOU'LL 5514 03:44:57,261 --> 03:44:59,664 GET Q & A AT THE END OF THE 5515 03:44:59,664 --> 03:45:05,369 SESSION. 5516 03:45:05,369 --> 03:45:08,806 NEXT IS DR. PETER BURBELO. 5517 03:45:08,806 --> 03:45:10,575 PLEASE TAKE IT AWAY. 5518 03:45:10,575 --> 03:45:14,078 >> CAN YOU SEE MY SCREEN? 5519 03:45:14,078 --> 03:45:18,616 >> YES, WE CAN SEE YOUR SCREEN. 5520 03:45:18,616 --> 03:45:20,118 >> HOW ABOUT RIGHT NOW, ARE WE 5521 03:45:20,118 --> 03:45:20,718 GOOD TO GO? 5522 03:45:20,718 --> 03:45:25,957 >> WE ARE GOOD. 5523 03:45:25,957 --> 03:45:27,125 >> GOOD AFTERNOON. 5524 03:45:27,125 --> 03:45:29,994 MY NAME IS PETER BURBELO. 5525 03:45:29,994 --> 03:45:31,229 I'M GOING TO BE TELLING YOU 5526 03:45:31,229 --> 03:45:32,797 REALLY A LOT MORE BASIC 5527 03:45:32,797 --> 03:45:33,865 INFORMATION ABOUT ANTIBODY 5528 03:45:33,865 --> 03:45:35,833 PROFILING AND AUTOIMMUNE AND 5529 03:45:35,833 --> 03:45:40,438 INFECTIOUS DISEASES, AND I WILL 5530 03:45:40,438 --> 03:45:42,373 TOUCH UPON A LITTLE BIT OF MY 5531 03:45:42,373 --> 03:45:45,209 INTERACTIONS WITH COMPANIES. 5532 03:45:45,209 --> 03:45:49,680 AGAIN, MY RESEARCH FOCUSES ON 5533 03:45:49,680 --> 03:45:51,415 USING A TECHNOLOGY I DEVELOPED 5534 03:45:51,415 --> 03:45:53,417 TO MEASURE ANTIBODIES, AND JUST 5535 03:45:53,417 --> 03:45:56,354 A LITTLE REFRESHER HOOR ON THE 5536 03:45:56,354 --> 03:45:57,688 LEFT, ANTIBODY, OF COURSE, ARE 5537 03:45:57,688 --> 03:46:01,359 TARGETING DIFFERENT PROTEINS AND 5538 03:46:01,359 --> 03:46:03,060 MOST PICK UP REALLY THESE LINEAR 5539 03:46:03,060 --> 03:46:06,631 EPITOPES REALLY WELL, BUT THE 5540 03:46:06,631 --> 03:46:07,999 CONFIRMATIONAL EPITOPES REQUIRE 5541 03:46:07,999 --> 03:46:09,066 PROPER FOLDING. 5542 03:46:09,066 --> 03:46:10,401 I'VE SORT OF SOLVED THAT ISSUE 5543 03:46:10,401 --> 03:46:12,136 BY DEVELOPING A TECHNOLOGY THAT 5544 03:46:12,136 --> 03:46:14,739 I CALL LUCIFERASE 5545 03:46:14,739 --> 03:46:19,043 IMMUNOPRECIPITATION SYSTEMS OR 5546 03:46:19,043 --> 03:46:22,180 LIPS FOR SHORT THAT USES 5547 03:46:22,180 --> 03:46:23,881 CHIMERIC ANTIGENS AS SHOWN HERE, 5548 03:46:23,881 --> 03:46:25,750 I BUILD CUSTOM-MADE ANTIGENS IN 5549 03:46:25,750 --> 03:46:28,386 MA NAILIAN EXPRESSION FACTORS 5550 03:46:28,386 --> 03:46:30,488 AND EXPRESS THEM IN CELLS. 5551 03:46:30,488 --> 03:46:32,123 BECAUSE THE ANTIGEN IS DIRECTLY 5552 03:46:32,123 --> 03:46:34,292 TAGGED WITH THIS LUCIFERASE 5553 03:46:34,292 --> 03:46:36,360 REPORTER, I DON'T NEED TO PURIFY 5554 03:46:36,360 --> 03:46:37,929 IT SO I CAN BUILD A TEST REALLY 5555 03:46:37,929 --> 03:46:39,730 QUITE QUICKLY, AS FAST AS I CAN 5556 03:46:39,730 --> 03:46:42,233 CLONE IT IN. 5557 03:46:42,233 --> 03:46:47,238 AND I'VE USED THAT TO MEASURE 5558 03:46:47,238 --> 03:46:49,874 ANTIBODIES IN THE SOLUTION PHASE 5559 03:46:49,874 --> 03:46:54,078 ASSAY, CAPTURED WITH BEADS AND 5560 03:46:54,078 --> 03:46:55,980 THE OUTPUT IS THIS LIGHT UNIT. 5561 03:46:55,980 --> 03:46:57,381 SHOWN ON THE RIGHT IS SORT OF 5562 03:46:57,381 --> 03:46:58,950 THE TYPICAL TYPE DATA THAT 5563 03:46:58,950 --> 03:47:02,520 YOU'LL BE SEEING, IS THAT OVER 5564 03:47:02,520 --> 03:47:04,622 QUITE A WIDE DYNAMIC RANGE OF 5565 03:47:04,622 --> 03:47:08,059 DETECTION, I CAN DETECT THESE 5566 03:47:08,059 --> 03:47:10,361 VISIBLE LIGHT UNITS AS SHOWN 5567 03:47:10,361 --> 03:47:11,462 HERE. 5568 03:47:11,462 --> 03:47:13,397 SO BEING AT NIH, I CAN DO SORT 5569 03:47:13,397 --> 03:47:14,599 OF ONE-STOP SHOPPING. 5570 03:47:14,599 --> 03:47:15,800 THERE'S SO MANY PEOPLE WORKING 5571 03:47:15,800 --> 03:47:18,402 ON SO MANY DIFFERENT HUMAN 5572 03:47:18,402 --> 03:47:19,704 DISEASES AND INFECTIOUS 5573 03:47:19,704 --> 03:47:22,473 DISEASES, AND SO I'VE BUILT 5574 03:47:22,473 --> 03:47:24,809 PROBABLY OVER 1500 TARGETS FOR 5575 03:47:24,809 --> 03:47:26,310 AUTOIMMUNE INFECTIOUS DISEASE, 5576 03:47:26,310 --> 03:47:27,912 AS I MENTIONED, I CAN PRODUCE 5577 03:47:27,912 --> 03:47:30,848 THESE REALLY QUICKLY, AND I TEST 5578 03:47:30,848 --> 03:47:32,817 THEM IN A 96-WELL FORMAT, 5579 03:47:32,817 --> 03:47:34,285 PROVIDING THIS REALLY HIGH 5580 03:47:34,285 --> 03:47:36,087 DEFINITION OUTPUT. 5581 03:47:36,087 --> 03:47:37,822 I'VE HAD A BIG FOCUS ON 5582 03:47:37,822 --> 03:47:39,457 AUTOIMMUNE TESTING, AS I'LL GET 5583 03:47:39,457 --> 03:47:40,458 INTO IT. 5584 03:47:40,458 --> 03:47:43,394 PUBLISHED A LOT, OVER 130 PAPERS 5585 03:47:43,394 --> 03:47:45,229 ON LOTS OF AGENTS. 5586 03:47:45,229 --> 03:47:47,531 I HAVE SEVERAL PATENTS, 5587 03:47:47,531 --> 03:47:48,266 INCLUDING ONE I'LL TALK ABOUT 5588 03:47:48,266 --> 03:47:52,670 VERY QUICKLY THAT USES THESE 5589 03:47:52,670 --> 03:47:55,239 MAGNETS FOR REALLY ULTRA RAPID 5590 03:47:55,239 --> 03:47:57,541 DETECTION OF ANTIBODIES, BUT MY 5591 03:47:57,541 --> 03:47:58,175 OVERARCHING GOAL REALLY IS TO 5592 03:47:58,175 --> 03:48:02,213 TRY TO DEVELOP A PANORAMIC 5593 03:48:02,213 --> 03:48:03,114 ANTIBODY SCREEN, SO LET'S GET 5594 03:48:03,114 --> 03:48:06,684 STARTED. 5595 03:48:06,684 --> 03:48:09,220 SO HERE'S AN EXAMPLE HERE ON THE 5596 03:48:09,220 --> 03:48:10,621 LEFT OF A REAL PROBLEM WE HAVE. 5597 03:48:10,621 --> 03:48:12,023 THERE ARE A LOT OF PEOPLE WITH 5598 03:48:12,023 --> 03:48:12,356 LYME DISEASE. 5599 03:48:12,356 --> 03:48:15,826 IT'S ABOUT A $500 MILLION 5600 03:48:15,826 --> 03:48:17,862 MARKET, AND BACK OVER A DECADE 5601 03:48:17,862 --> 03:48:21,265 AND A HALF AGO, I SCREENED A 5602 03:48:21,265 --> 03:48:23,334 BUNCH OF LYME ANTIGENS AND 5603 03:48:23,334 --> 03:48:28,139 BASICALLY ENDED UP IDENTIFYING 5604 03:48:28,139 --> 03:48:29,373 SEVERAL ANTIGENS THAT ARE USEFUL 5605 03:48:29,373 --> 03:48:31,375 AND I MADE A CONGLOMERATE 5606 03:48:31,375 --> 03:48:31,609 ANTIGEN. 5607 03:48:31,609 --> 03:48:34,946 AS YOU CAN SEE HERE, IT PICKS UP 5608 03:48:34,946 --> 03:48:36,380 REALLY QUITE NICE, AGAIN, ON 5609 03:48:36,380 --> 03:48:37,949 THIS LOG 10 SCALE, ALL OF THE 5610 03:48:37,949 --> 03:48:39,583 LIME PATIENTS AS BEING POSITIVE 5611 03:48:39,583 --> 03:48:40,918 WITH THIS CUTOFF BEING THE 5612 03:48:40,918 --> 03:48:45,656 DOTTED LINE. 5613 03:48:45,656 --> 03:48:49,060 AND COMPARED TO THE EXISTING 5614 03:48:49,060 --> 03:48:52,129 BEST ASSAY OUT THERE, WHICH HAS 5615 03:48:52,129 --> 03:48:53,631 76% SENSITIVITY, SO AGAIN, 5616 03:48:53,631 --> 03:48:55,733 PICKING UP ONLY ABOUT 76% OF THE 5617 03:48:55,733 --> 03:48:58,035 SAMPLES, I COULD PICK UP 94% 5618 03:48:58,035 --> 03:48:59,236 WITH 100% SPECIFICITY. 5619 03:48:59,236 --> 03:49:00,604 JUST SHOWING I COULD BUILD A 5620 03:49:00,604 --> 03:49:03,574 BETTER TEST. 5621 03:49:03,574 --> 03:49:06,410 MY INTERACTION WITH THE COMPANY 5622 03:49:06,410 --> 03:49:07,712 IS THE COMPANY THOUGHT THE 5623 03:49:07,712 --> 03:49:08,913 TARGET WAS REALLY GREAT AND THEY 5624 03:49:08,913 --> 03:49:12,183 LICENSED IT, BUT I THINK THEY'RE 5625 03:49:12,183 --> 03:49:13,951 WORKING ON IT BUT HAVEN'T HAD 5626 03:49:13,951 --> 03:49:16,187 TOO MUCH MORE INTERACTION. 5627 03:49:16,187 --> 03:49:22,259 BUT IT JI JUST GIVES YOU THE TYA 5628 03:49:22,259 --> 03:49:23,794 FLAVOR OF THE TYPES OF ASSAYS I 5629 03:49:23,794 --> 03:49:24,462 CAN BUILD. 5630 03:49:24,462 --> 03:49:25,963 DURING THE PANDEMIC, I WAS LUCKY 5631 03:49:25,963 --> 03:49:27,231 ENOUGH TO WORK WITH SOME OF THE 5632 03:49:27,231 --> 03:49:29,333 FIRST SAMPLES IN THE U.S. 5633 03:49:29,333 --> 03:49:31,302 INFECTED WITH SARS-COV-2, AND I 5634 03:49:31,302 --> 03:49:34,572 BUILT SORT OF IN REALTIME A 5635 03:49:34,572 --> 03:49:40,578 NUCLEIC CASS PID AS -- SPIKE, O0 5636 03:49:40,578 --> 03:49:42,213 STUDY, ONE OF PROBABLY 25,000 5637 03:49:42,213 --> 03:49:45,716 SAMPLES I ANALYZED, WE LOOKED AT 5638 03:49:45,716 --> 03:49:47,818 BOTH NUCLEIC CAPSID AND JUST 5639 03:49:47,818 --> 03:49:50,621 SHOWING YOU AGAIN THAT WE COULD 5640 03:49:50,621 --> 03:49:51,589 DETECT ANTIBODIES IN SOME OF 5641 03:49:51,589 --> 03:49:52,690 THESE PATIENTS REALLY QUITE 5642 03:49:52,690 --> 03:49:57,795 EARLY. 5643 03:49:57,795 --> 03:49:59,263 SO FOR INFECTIOUS DISEASE, I 5644 03:49:59,263 --> 03:50:00,664 CANNOT ONLY LOOK AT ONE ANTIGEN, 5645 03:50:00,664 --> 03:50:02,967 I CAN BUILD PANELS, FOR EXAMPLE, 5646 03:50:02,967 --> 03:50:07,038 THE HIV PROTEOME SHOWN ON THE 5647 03:50:07,038 --> 03:50:08,439 RIGHT, WE'VE USED THAT TO LOOK 5648 03:50:08,439 --> 03:50:09,673 AT DIFFERENT SUBSETS OF PEOPLE 5649 03:50:09,673 --> 03:50:11,042 WITH HIV, FOR EXAMPLE, ONE OF 5650 03:50:11,042 --> 03:50:12,476 THE FIRST PERSONS CURED OF HIV 5651 03:50:12,476 --> 03:50:14,812 CALLED THE BERLIN PATIENT HAS 5652 03:50:14,812 --> 03:50:18,716 REALLY LOW ANTIBODIES, BUT SO 5653 03:50:18,716 --> 03:50:23,287 AGAIN, USING THIS PLATFORM FOR 5654 03:50:23,287 --> 03:50:24,388 INFECTIOUS DISEASE IS REALLY 5655 03:50:24,388 --> 03:50:25,122 QUITE OBVIOUS. 5656 03:50:25,122 --> 03:50:28,859 WE HAVE EVEN USED TO IDENTIFY 5657 03:50:28,859 --> 03:50:30,961 NEW HUMAN PATHOGENS AS WELL AS 5658 03:50:30,961 --> 03:50:33,864 ANIMAL PATHOGENS USING THIS, WE 5659 03:50:33,864 --> 03:50:35,132 ACTUALLY WERE THE FIRST TO 5660 03:50:35,132 --> 03:50:37,601 DESCRIBE A HEPATITIS-LIKE C 5661 03:50:37,601 --> 03:50:40,971 VIRUS OUTSIDE OF PRIMATES. 5662 03:50:40,971 --> 03:50:42,840 BUT SO AGAIN, ONE VISION I HAVE 5663 03:50:42,840 --> 03:50:44,708 IS TO GET A COMPANY POTENTIALLY 5664 03:50:44,708 --> 03:50:46,710 TO BUILD THIS PANORAMIC SCREEN 5665 03:50:46,710 --> 03:50:49,280 FOR INFECTIOUS AND AUTOIMMUNE AS 5666 03:50:49,280 --> 03:50:50,481 YOU'LL SEE. 5667 03:50:50,481 --> 03:50:52,483 ANOTHER IS TO BUILD REALLY RAPID 5668 03:50:52,483 --> 03:50:56,654 TESTS, AND SO HBV16, AS MANY OF 5669 03:50:56,654 --> 03:50:58,322 YOU KNOW, CAN CAUSE HEAD AND 5670 03:50:58,322 --> 03:50:59,657 NECK CANCER, AND THERE WAS A 5671 03:50:59,657 --> 03:51:03,160 SMALL COHORT WHERE I USED 5672 03:51:03,160 --> 03:51:03,727 MULTIPLE ANTIGENS, I'M ONLY 5673 03:51:03,727 --> 03:51:05,963 SHOWING YOU ONE, THAT WE PICKED 5674 03:51:05,963 --> 03:51:07,498 UP SEVERAL, EIGHT OR NINE 5675 03:51:07,498 --> 03:51:10,134 PATIENTS WITH ANTIBODIES TO HPV, 5676 03:51:10,134 --> 03:51:11,702 MOST LIKELY DRIVING THE DISEASE, 5677 03:51:11,702 --> 03:51:17,208 AND USING THESE SAME LUCIFERASE 5678 03:51:17,208 --> 03:51:20,511 FUSION PROTEINS, I CAN DETECT 5679 03:51:20,511 --> 03:51:22,246 VERY, VERY RAPIDLY, IN ONE 5680 03:51:22,246 --> 03:51:24,281 MINUTE, MANY OF THOSE SAME 5681 03:51:24,281 --> 03:51:25,082 POSITIVES. 5682 03:51:25,082 --> 03:51:26,617 THE ASSAY ISN'T READY FOR PRIME 5683 03:51:26,617 --> 03:51:29,120 TIME, I'M STILL THINKING THERE'S 5684 03:51:29,120 --> 03:51:30,588 MAYBE A BETTER FORMAT, BUT I'M 5685 03:51:30,588 --> 03:51:33,023 JUST GOING TO LEAVE IT THERE. 5686 03:51:33,023 --> 03:51:35,759 SO AUTOIMMUNE DISEASES, AS YOU 5687 03:51:35,759 --> 03:51:39,163 MAY KNOW, PRESENT REALLY SEVERAL 5688 03:51:39,163 --> 03:51:41,132 CHALLENGES. 5689 03:51:41,132 --> 03:51:42,266 ONE INHERENT CHALLENGE IS THAT 5690 03:51:42,266 --> 03:51:44,502 THEY'RE OFTEN INCREDIBLY 5691 03:51:44,502 --> 03:51:47,037 HETEROGENEOUS AND YOU NEED 5692 03:51:47,037 --> 03:51:48,105 MULTIPLE ANTIGEN TARGETS TO PICK 5693 03:51:48,105 --> 03:51:50,774 UP POSITIVITY. 5694 03:51:50,774 --> 03:51:55,980 AGAIN, WE'VE DONE THAT IN TYPE A 5695 03:51:55,980 --> 03:51:57,181 PANEL THAT CAN PICK UP MOST OF 5696 03:51:57,181 --> 03:52:00,584 THE SAMPLES, AND THIS IS QUITE 5697 03:52:00,584 --> 03:52:01,318 OLD. 5698 03:52:01,318 --> 03:52:03,621 BUT MORE RECENTLY EVEN, ADULT 5699 03:52:03,621 --> 03:52:08,025 ONSET TYPE 1 DIABETES HAVE, 5700 03:52:08,025 --> 03:52:09,660 WE'VE DONE A STUDY WHERE WE CAN 5701 03:52:09,660 --> 03:52:12,296 DETECT THESE ANTIBODIES A DECADE 5702 03:52:12,296 --> 03:52:13,130 OR TWO DECADE BEFOREHAND. 5703 03:52:13,130 --> 03:52:14,665 IN CHILDREN, WE KNOW THESE 5704 03:52:14,665 --> 03:52:17,268 ANTIBODIES ARE PRESENT IN FIVE 5705 03:52:17,268 --> 03:52:18,936 TO 10 YEARS BEFORE THEY ACTUALLY 5706 03:52:18,936 --> 03:52:23,374 REQUIRE INSULIN, AND THERE'S NOW 5707 03:52:23,374 --> 03:52:25,476 AN FDA-APPROVED DRUG THAT 5708 03:52:25,476 --> 03:52:27,545 TARGETS CD3 THAT CAN DELAY THIS. 5709 03:52:27,545 --> 03:52:29,079 SO THERE'S BIG INTEREST IN 5710 03:52:29,079 --> 03:52:31,682 REALLY IDENTIFYING PATIENTS AT 5711 03:52:31,682 --> 03:52:33,450 RISK, AND WE'VE DONE SIMILAR 5712 03:52:33,450 --> 03:52:34,752 THINGS, I'M NOT GOING TO GO INTO 5713 03:52:34,752 --> 03:52:38,489 THE BIG DETAILS, BUT I IN LUPUS, 5714 03:52:38,489 --> 03:52:39,990 WE'VE IDENTIFIED DIFFERENT 5715 03:52:39,990 --> 03:52:41,625 SUBSETS AND IN SCLERODERMA, 5716 03:52:41,625 --> 03:52:43,594 WHICH IS EVEN MORE HETEROGENEOUS 5717 03:52:43,594 --> 03:52:45,596 WE'VE IDENTIFIED ALSO 5718 03:52:45,596 --> 03:52:47,198 INFORMATIVE ANTIGENS. 5719 03:52:47,198 --> 03:52:50,100 I'M JUST SHOWING YOU ONE PATIENT 5720 03:52:50,100 --> 03:52:52,203 HERE AT THE TOP, THIS THREE 5721 03:52:52,203 --> 03:52:55,573 CLUSTER UP HERE, USING SAMPLES 5722 03:52:55,573 --> 03:52:57,908 FROM THE ARMY ACROSS THE STREET, 5723 03:52:57,908 --> 03:52:58,709 BIOBANK SAMPLES. 5724 03:52:58,709 --> 03:53:00,844 SOME OF THESE PATIENTS HAVE 5725 03:53:00,844 --> 03:53:02,446 ANTIBODIES 27 YEARS BEFORE THE 5726 03:53:02,446 --> 03:53:03,847 ONSET, BEFORE THEY'RE DIAGNOSED 5727 03:53:03,847 --> 03:53:09,386 WITH SCLERODERMA. 5728 03:53:09,386 --> 03:53:10,854 OR 16, 17 YEARS, SO IT REALLY 5729 03:53:10,854 --> 03:53:11,956 SHOWS YOU THE OPPORTUNITY THAT 5730 03:53:11,956 --> 03:53:16,026 WE CAN HOPEFULLY HAVE. 5731 03:53:16,026 --> 03:53:17,294 ONE, BEING IN THE DENTAL 5732 03:53:17,294 --> 03:53:18,529 INSTITUTE, I'M PARTICULARLY 5733 03:53:18,529 --> 03:53:20,598 INTERESTED IN A DISEASE CALLED 5734 03:53:20,598 --> 03:53:22,967 SJOGREN'S DISEASE, WHICH CAUSES 5735 03:53:22,967 --> 03:53:25,502 ESSENTIALLY ORAL AND OCULAR 5736 03:53:25,502 --> 03:53:26,904 DRYNESS, TYPICALLY CHARACTERIZED 5737 03:53:26,904 --> 03:53:28,439 BY INFLAMMATION, AND AGAIN, 5738 03:53:28,439 --> 03:53:30,641 SHOWING YOU HOW A TEST I 5739 03:53:30,641 --> 03:53:32,276 DEVELOPED FOR ONE OF THE COMMON 5740 03:53:32,276 --> 03:53:36,647 ANTIGENS CALLED SSB THAT PICKS 5741 03:53:36,647 --> 03:53:40,484 UP ONLY 52% AND THE LIPS ASSAY 5742 03:53:40,484 --> 03:53:41,719 CAN PICK UP 76%. 5743 03:53:41,719 --> 03:53:43,420 SO HOW CAN ALL OF THESE PROFILES 5744 03:53:43,420 --> 03:53:45,222 BE USEFUL? 5745 03:53:45,222 --> 03:53:46,924 WELL, HERE'S ONE TO START WITH. 5746 03:53:46,924 --> 03:53:50,127 SO SJOGREN'S IS NOT ONLY A 5747 03:53:50,127 --> 03:53:52,062 DISEASE THAT AFFECTS JUST THE 5748 03:53:52,062 --> 03:53:53,364 SALIVARY GLAND, THEY HAVE 5749 03:53:53,364 --> 03:53:54,798 INCREASED RISK OF LYMPHOMA, AND 5750 03:53:54,798 --> 03:53:58,269 THEY HAVE A LOT OF DIVERSE EXTRA 5751 03:53:58,269 --> 03:54:01,105 GLANDULAR SYMPTOMS. 5752 03:54:01,105 --> 03:54:03,741 AND I'VE DEVELOPED THE PANEL OF 5753 03:54:03,741 --> 03:54:06,043 THESE SPECIFIC TARGETS IN 5754 03:54:06,043 --> 03:54:08,245 DIFFERENT TISSUES, SO FOR 5755 03:54:08,245 --> 03:54:10,581 EXAMPLE, ANTIBODIES TO AQUAPORIN 5756 03:54:10,581 --> 03:54:11,749 4 FOUND IN A FEW PATIENTS, AND 5757 03:54:11,749 --> 03:54:14,018 WE FOUND SOME OF THEM TO HAVE 5758 03:54:14,018 --> 03:54:14,585 NEUROPATHY. 5759 03:54:14,585 --> 03:54:15,586 THERE'S EVEN A SUBSET OF 5760 03:54:15,586 --> 03:54:19,156 PATIENTS WHO HAVE ANTIBODY TO A 5761 03:54:19,156 --> 03:54:21,659 RECEPTOR ON THE SURFACE THAT 5762 03:54:21,659 --> 03:54:23,193 ASSOCIATE WITH AUTONOMIC 5763 03:54:23,193 --> 03:54:23,627 DYSFUNCTION. 5764 03:54:23,627 --> 03:54:25,496 WE'VE HAD MARKERS OF THYROID, 5765 03:54:25,496 --> 03:54:29,433 LIVER, STOMACH, EVEN 5766 03:54:29,433 --> 03:54:31,302 INTERSTITIAL LUNG DISEASE. 5767 03:54:31,302 --> 03:54:33,704 AND SO AGAIN, I THINK THIS SORT 5768 03:54:33,704 --> 03:54:36,473 OF LOOKS AT SORT OF THE 5769 03:54:36,473 --> 03:54:38,375 PERSONALIZED DIAGNOSIS THAT IS 5770 03:54:38,375 --> 03:54:41,879 POSSIBLE USING THIS TECHNOLOGY. 5771 03:54:41,879 --> 03:54:44,048 BUT FOLLOWING ON ON SOME OF 5772 03:54:44,048 --> 03:54:45,983 THESE MARKERS, THE ONES THAT ARE 5773 03:54:45,983 --> 03:54:49,753 ON THE SURFACE, LIKE WHICH I 5774 03:54:49,753 --> 03:54:52,456 JUST TOLD YOU, CHOLINERGIC 5775 03:54:52,456 --> 03:54:53,924 RECEPTOR OR AQUAPORIN RECEPTOR, 5776 03:54:53,924 --> 03:54:55,392 AGAIN, IF THERE ARE ANTIBODIES 5777 03:54:55,392 --> 03:54:57,394 TO PROTEINS THAT ARE ON THE 5778 03:54:57,394 --> 03:54:58,595 SURFACE, WE GENERALLY THINK OF 5779 03:54:58,595 --> 03:55:00,998 THEM AS POTENTIALLY BEING 5780 03:55:00,998 --> 03:55:03,300 PATHOGENIC BECAUSE THE ANTIBODY 5781 03:55:03,300 --> 03:55:06,003 CAN DISRUPT THE SIGNALING OR THE 5782 03:55:06,003 --> 03:55:08,839 FUNCTION OF THAT PROTEIN ON THE 5783 03:55:08,839 --> 03:55:09,973 SURFACE, AS WELL AS PROTEINS 5784 03:55:09,973 --> 03:55:11,075 THAT ARE SECRETED. 5785 03:55:11,075 --> 03:55:13,577 ANYTHING THAT'S REALLY 5786 03:55:13,577 --> 03:55:16,480 EXTRACELLULAR HAS ACCESS TO 5787 03:55:16,480 --> 03:55:17,247 THESE ANTIBODIES, AND I'VE BEEN 5788 03:55:17,247 --> 03:55:19,016 ON A BUNCH OF PAPERS WHERE WE 5789 03:55:19,016 --> 03:55:22,753 WERE SORT OF THE FIRST TO 5790 03:55:22,753 --> 03:55:24,254 DESCRIBE ANTICYTOKINE ANTIBODIES 5791 03:55:24,254 --> 03:55:26,490 ASSOCIATED WITH OPPORTUNISTIC 5792 03:55:26,490 --> 03:55:27,691 INFECTION IN A BUNCH OF 5793 03:55:27,691 --> 03:55:30,694 DIFFERENT DISEASES. 5794 03:55:30,694 --> 03:55:32,863 WE'VE FOUND, INTERESTINGLY IN 5795 03:55:32,863 --> 03:55:34,665 COVID TIMES, THESE SAME 5796 03:55:34,665 --> 03:55:36,400 ANTIBODIES TURNED OUT TO BE 5797 03:55:36,400 --> 03:55:41,638 REALLY A MAJOR MORBIDITY MARKER 5798 03:55:41,638 --> 03:55:44,274 CAUSING MORBIDITY AND MORTALITY 5799 03:55:44,274 --> 03:55:48,278 OF OLDER MEN AND COVID. 5800 03:55:48,278 --> 03:55:50,748 BUT AGAIN, IF THE ANTIBODY, SOME 5801 03:55:50,748 --> 03:55:53,117 OF THESE MOLECULES ARE QUITE 5802 03:55:53,117 --> 03:55:57,388 LARGE AND DIFFICULT TO DETECT 5803 03:55:57,388 --> 03:55:58,489 ANTIBODIES TO, AND SO THERE'S A 5804 03:55:58,489 --> 03:56:01,625 REAL OPPORTUNITY, AGAIN, WITH 5805 03:56:01,625 --> 03:56:03,527 LIPS TO DETECT THESE ANTIBODIES. 5806 03:56:03,527 --> 03:56:05,362 I'M JUST SHOWING YOU HERE ON THE 5807 03:56:05,362 --> 03:56:07,664 LEFT THAT YOU CAN ACTUALLY 5808 03:56:07,664 --> 03:56:09,099 MONITOR PROTEINURIA IN PATIENTS 5809 03:56:09,099 --> 03:56:12,469 WITH AUTOIMMUNE KIDNEY DISEASE. 5810 03:56:12,469 --> 03:56:15,005 YOU CAN SEE ON THE RIGHT, Y 5811 03:56:15,005 --> 03:56:20,544 AXIS, PATIENT IS EXCRETING ABOUT 5812 03:56:20,544 --> 03:56:24,248 10 GRAMS OF PROTEIN AND THE 5813 03:56:24,248 --> 03:56:25,349 ANTIBODY IS STILL ABOVE THIS 5814 03:56:25,349 --> 03:56:26,350 DOTTED BLUE LINE, AND IF YOU 5815 03:56:26,350 --> 03:56:28,218 TREAT THIS PATIENT, YOU SEE HOW 5816 03:56:28,218 --> 03:56:29,653 NICELY THESE TWO TRACK. 5817 03:56:29,653 --> 03:56:32,456 HERE'S A PATIENT THAT'S 5818 03:56:32,456 --> 03:56:33,357 UNDERGOING RELAPSE AND 5819 03:56:33,357 --> 03:56:33,791 REMITTING. 5820 03:56:33,791 --> 03:56:35,325 YOU CAN SEE HOW THE ANTIBODY 5821 03:56:35,325 --> 03:56:37,060 ACTUALLY IN SOME CASES CAN 5822 03:56:37,060 --> 03:56:38,362 PREDICT THE RELAPSE. 5823 03:56:38,362 --> 03:56:40,464 AND SO THIS IS REALLY QUITE 5824 03:56:40,464 --> 03:56:43,167 EXCITING IN THE FIELD OF 5825 03:56:43,167 --> 03:56:44,301 MEMBRANOUS, THIS SEEMS TO BE ONE 5826 03:56:44,301 --> 03:56:45,436 OF THE WAYS THAT YOU DON'T NEED 5827 03:56:45,436 --> 03:56:47,371 TO DO BIOPSY, YOU CAN SORT OF 5828 03:56:47,371 --> 03:56:52,576 TRACK THE DISEASE. 5829 03:56:52,576 --> 03:56:53,710 ONE OF THE LAST THINGS I WANT TO 5830 03:56:53,710 --> 03:56:54,678 SORT OF LEAVE YOU WITH IS 5831 03:56:54,678 --> 03:56:56,780 THERE'S A BIG OPPORTUNITY IN THE 5832 03:56:56,780 --> 03:57:01,985 FACT THAT THIS PROBABLY 5833 03:57:01,985 --> 03:57:02,886 UNRECOGNIZED AUTOIMMUNITY IN 5834 03:57:02,886 --> 03:57:05,389 MANY DISEASES, ESPECIALLY THESE 5835 03:57:05,389 --> 03:57:06,256 PATHOGENIC ANTIBODIES THAT CAN 5836 03:57:06,256 --> 03:57:08,659 ACTUALLY CAUSE DISEASE. 5837 03:57:08,659 --> 03:57:10,427 THIS IS A STUDY THAT'S ONGOING 5838 03:57:10,427 --> 03:57:13,630 AND EXPANDING, IS THAT WE FOUND 5839 03:57:13,630 --> 03:57:16,667 THAT ABOUT 25% OF HIV PATIENTS 5840 03:57:16,667 --> 03:57:19,136 HAVE ANTIBOL DETO THE 5841 03:57:19,136 --> 03:57:20,504 CD4 RECEPTOR. 5842 03:57:20,504 --> 03:57:24,308 AGAIN, HIV BINDS TO THAT 5843 03:57:24,308 --> 03:57:26,043 RECEPTOR AND IT'S KEY, AND THESE 5844 03:57:26,043 --> 03:57:27,077 ANTIBODIES APPEAR TO BE 5845 03:57:27,077 --> 03:57:28,479 PATHOGENIC BECAUSE, AGAIN, IF 5846 03:57:28,479 --> 03:57:32,516 YOU HAVE THESE ANTIBODIES, YOUR 5847 03:57:32,516 --> 03:57:34,618 REBOUND OF CD4 COUNTS IS MUCH, 5848 03:57:34,618 --> 03:57:36,587 MUCH IMPAIRED COMPARED TO 5849 03:57:36,587 --> 03:57:38,222 PATIENTS WHO DO NOT HAVE THESE 5850 03:57:38,222 --> 03:57:38,755 ANTIBODIES. 5851 03:57:38,755 --> 03:57:42,493 SO AGAIN, THIS IS SORT OF STILL 5852 03:57:42,493 --> 03:57:44,795 AN EVOLVING AREA OF PATHOGENIC 5853 03:57:44,795 --> 03:57:45,596 ANTIBODIES IN DIFFERENT 5854 03:57:45,596 --> 03:57:47,297 DISEASES. 5855 03:57:47,297 --> 03:57:49,800 SO I JUST AGAIN WANT TO END AND 5856 03:57:49,800 --> 03:57:51,468 SAY THAT I'VE HAD SOME 5857 03:57:51,468 --> 03:57:54,304 INDUSTRIAL COLLABORATIONS, BUT 5858 03:57:54,304 --> 03:57:55,405 MAINLY THEY'RE INTERESTED IN A 5859 03:57:55,405 --> 03:57:55,973 SINGLE TARGET. 5860 03:57:55,973 --> 03:57:57,274 MY GOAL IS POTENTIALLY FOR 5861 03:57:57,274 --> 03:57:59,243 DEVELOPMENT OF SOME TYPE OF 5862 03:57:59,243 --> 03:58:00,744 PANORAMIC SCREENING PLATFORM, 5863 03:58:00,744 --> 03:58:03,146 AND WE COULD PROPOSE TO USE THAT 5864 03:58:03,146 --> 03:58:06,416 FOR BETTER DIAGNOSIS AND 5865 03:58:06,416 --> 03:58:06,783 TREATMENT. 5866 03:58:06,783 --> 03:58:09,186 MANY OF THE AUTOANTIBODIES AND 5867 03:58:09,186 --> 03:58:10,521 AUTOIMMUNE DISEASE ARE PRESENT 5868 03:58:10,521 --> 03:58:13,023 YEARS BEFORE, SO WE CAN USE 5869 03:58:13,023 --> 03:58:14,324 THOSE TO POTENTIALLY INTERVENE 5870 03:58:14,324 --> 03:58:17,261 IN THE AUTOIMMUNE DISEASE, AND 5871 03:58:17,261 --> 03:58:19,663 WE'VE ALSO AS I SHOWED YOU IN 5872 03:58:19,663 --> 03:58:21,198 THE MEMBRANOUS SOME OF THESE 5873 03:58:21,198 --> 03:58:22,633 ANTIBODIES GO UP AND DOWN AND 5874 03:58:22,633 --> 03:58:23,901 ARE GREAT MARKERS IN RESUMMONS 5875 03:58:23,901 --> 03:58:26,904 RESPONSE TOTREATMENT. 5876 03:58:26,904 --> 03:58:27,437 I'LL STOP THERE. 5877 03:58:27,437 --> 03:58:27,971 THANK YOU VERY MUCH. 5878 03:58:27,971 --> 03:58:29,606 >> THANK YOU SO MUCH, PETE TER. 5879 03:58:29,606 --> 03:58:33,644 TR.THAT WAS AN EXCELLENT OVERVIW 5880 03:58:33,644 --> 03:58:35,846 OF THE WORK THAT YOU'VE DONE AND 5881 03:58:35,846 --> 03:58:36,880 SOME POTENTIAL COLLABORATIONS 5882 03:58:36,880 --> 03:58:38,048 AND SO FORTH. 5883 03:58:38,048 --> 03:58:48,559 NOW I WOULD REQUEST DR. LEPTAK 5884 03:58:50,294 --> 03:58:51,328 TO PLEASE TAKE IT AWAY. 5885 03:58:51,328 --> 03:58:51,595 THANK YOU. 5886 03:58:51,595 --> 03:58:53,463 >> THE PREVIOUS PRESENTER, IF 5887 03:58:53,463 --> 03:58:55,232 THEY COULD STOP SHARING THEIR 5888 03:58:55,232 --> 03:58:55,465 SCREEN? 5889 03:58:55,465 --> 03:58:56,867 I'M NOT ABLE TO SHARE. 5890 03:58:56,867 --> 03:59:07,077 THERE WE GO. 5891 03:59:17,554 --> 03:59:18,789 HOPEFULLY EVERYONE CAN SEE THE 5892 03:59:18,789 --> 03:59:19,222 SCREEN? 5893 03:59:19,222 --> 03:59:20,357 >> WE CAN SEE THE SCREEN BUT WE 5894 03:59:20,357 --> 03:59:23,193 ARE LIKE IN THE PRESENTER'S -- 5895 03:59:23,193 --> 03:59:23,760 >> THERE WE GO. 5896 03:59:23,760 --> 03:59:25,228 >> OKAY, PERFECT. 5897 03:59:25,228 --> 03:59:25,562 >> EXCELLENT. 5898 03:59:25,562 --> 03:59:26,797 THANK YOU ALL FOR THE 5899 03:59:26,797 --> 03:59:28,498 OPPORTUNITY TO PARTICIPATE IN 5900 03:59:28,498 --> 03:59:32,235 THE PANEL DISCUSSION TODAY. 5901 03:59:32,235 --> 03:59:33,904 AS BASED ON MY BACKGROUND, I 5902 03:59:33,904 --> 03:59:35,639 THINK WHAT I BRING TO THE 5903 03:59:35,639 --> 03:59:39,509 CONVERSATION IS THE UTILITY AND 5904 03:59:39,509 --> 03:59:40,677 IMPORTANCE OF THE COLLABORATION, 5905 03:59:40,677 --> 03:59:42,112 BUT THEN BRINGING IN ONE OF THE 5906 03:59:42,112 --> 03:59:44,081 SISTER AGENCIES AS PART OF THE 5907 03:59:44,081 --> 03:59:44,915 OVERALL DISCUSSION, THAT WOULD 5908 03:59:44,915 --> 03:59:49,086 BE NAMELY THE FDA. 5909 03:59:49,086 --> 03:59:51,221 CERTAINLY JUST TO BORROW AN OLD 5910 03:59:51,221 --> 03:59:54,324 ADAGE, IT REALLY DOES TAKE A 5911 03:59:54,324 --> 03:59:56,960 VILLAGE TO IDENTIFY AND 5912 03:59:56,960 --> 03:59:59,896 ULTIMATELY -- THAT INCLUDES A 5913 03:59:59,896 --> 04:00:01,632 BROAD ARRAY OF PARTNERSHIPS FROM 5914 04:00:01,632 --> 04:00:03,567 INDUSTRY, NIH, FDA, PATIENT 5915 04:00:03,567 --> 04:00:04,401 ADVOCACY, ET CETERA. 5916 04:00:04,401 --> 04:00:06,269 AND IT'S THOSE COLLABORATIVE 5917 04:00:06,269 --> 04:00:08,872 EFFORTS THAT ULTIMATELY YIELD 5918 04:00:08,872 --> 04:00:10,641 THE GREATEST FRUIT BECAUSE IT'S 5919 04:00:10,641 --> 04:00:12,509 ALMOST IMPOSSIBLE FOR A GIVEN 5920 04:00:12,509 --> 04:00:14,044 ENTITY JUST BASED ON RESEARCH 5921 04:00:14,044 --> 04:00:16,780 LIMITATIONS ALONE TO DEVELOP A 5922 04:00:16,780 --> 04:00:18,215 BIOMARKER THAT ULTIMATELY CAN 5923 04:00:18,215 --> 04:00:19,950 HELP A PATIENT POPULATION, 5924 04:00:19,950 --> 04:00:21,051 EITHER THROUGH DRUG DEVELOPMENT 5925 04:00:21,051 --> 04:00:22,052 OR DIAGNOSTIC DEVELOPMENT, ET 5926 04:00:22,052 --> 04:00:24,888 CETERA. 5927 04:00:24,888 --> 04:00:27,758 MUCH LIKE ALL OF MY TALKS, WHILE 5928 04:00:27,758 --> 04:00:29,226 I WAS AT THE FDA, I'M CERTAINLY 5929 04:00:29,226 --> 04:00:33,330 NO LONGER SPEAKING FOR THE FDA. 5930 04:00:33,330 --> 04:00:35,098 NOR AM I SORT OF ENDORSING A 5931 04:00:35,098 --> 04:00:35,932 PARTICULAR COMPANY POSITION AND 5932 04:00:35,932 --> 04:00:40,237 I DON'T HAVE ANY DISCLOSURES. 5933 04:00:40,237 --> 04:00:41,638 SO CERTAINLY AS YOU'VE SEEN FROM 5934 04:00:41,638 --> 04:00:43,940 THE TALKS TODAY, THE BIOMARKERS 5935 04:00:43,940 --> 04:00:47,010 ARE ACCEPTED TO BEI BE OF A BROD 5936 04:00:47,010 --> 04:00:49,980 VARIETY, INCLUDING MOLECULAR, 5937 04:00:49,980 --> 04:00:50,747 HISTOLOGIC, RADIOGRAPHIC, 5938 04:00:50,747 --> 04:00:51,481 DIGITAL, ET CETERA. 5939 04:00:51,481 --> 04:00:52,282 ALL OF THOSE FALL INTO THE 5940 04:00:52,282 --> 04:00:54,818 RUBRIC OF A DEFINED 5941 04:00:54,818 --> 04:00:56,219 CHARACTERISTIC THAT'S BEEN AT 5942 04:00:56,219 --> 04:00:59,723 THE CRUX OF HOW FDA AND OTHER 5943 04:00:59,723 --> 04:01:01,391 AGENCIES HAVE LOOKED AT 5944 04:01:01,391 --> 04:01:02,926 BIOMARKERS FOR DECADES. 5945 04:01:02,926 --> 04:01:05,262 AND THE KEY ASPECT HERE IS THE 5946 04:01:05,262 --> 04:01:07,130 DEFINED CHARACTERISTIC PIECE OF 5947 04:01:07,130 --> 04:01:08,799 THIS. 5948 04:01:08,799 --> 04:01:09,800 SO I THINK IT'S IMPORTANT 5949 04:01:09,800 --> 04:01:11,168 WHETHER YOU'RE IN INDUSTRY OR IN 5950 04:01:11,168 --> 04:01:15,038 NIH THAT YOU REALLY SIT DOWN AND 5951 04:01:15,038 --> 04:01:16,540 ARTICULATE WHAT YOU MEAN BY THE 5952 04:01:16,540 --> 04:01:17,140 BIOMARKER. 5953 04:01:17,140 --> 04:01:19,810 BECAUSE THE TERM KIND OF COMES 5954 04:01:19,810 --> 04:01:22,279 UP VERY LOOSELY, SO FOR 5955 04:01:22,279 --> 04:01:23,113 INSTANCE, ARE YOU TALKING ABOUT 5956 04:01:23,113 --> 04:01:25,382 A CHANGE FROM BASELINE, ARE YOU 5957 04:01:25,382 --> 04:01:26,983 TALKING ABOUT A CHANGE OVER 5958 04:01:26,983 --> 04:01:28,251 TIME, ARE YOU TALKING ABOUT A 5959 04:01:28,251 --> 04:01:28,685 MEAN CHANGE. 5960 04:01:28,685 --> 04:01:31,321 YOU KNOW, ALL THOSE KIND OF 5961 04:01:31,321 --> 04:01:33,223 NUANCES BECOME IMPORTANT AS YOU 5962 04:01:33,223 --> 04:01:33,857 START TO LOOK AT THE DATA THAT 5963 04:01:33,857 --> 04:01:37,360 YOU'RE COLLECTING AND HOW IT 5964 04:01:37,360 --> 04:01:39,763 MIGHT BE ADMISSIBLE AS PART OF A 5965 04:01:39,763 --> 04:01:43,433 FUTURE DRUG DEVELOPMENT EFFORT. 5966 04:01:43,433 --> 04:01:44,501 I WOULD ALSO LIKE TO DRAW 5967 04:01:44,501 --> 04:01:45,802 ATTENTION TO A COLLABORATIVE 5968 04:01:45,802 --> 04:01:47,237 EFFORT THAT I WAS INVOLVED WITH 5969 04:01:47,237 --> 04:01:48,672 AS PART OF NIH AND FDA, AND THAT 5970 04:01:48,672 --> 04:01:51,508 WAS THE DEVELOPMENT OF THE BEST 5971 04:01:51,508 --> 04:01:54,111 RESOURCE, WHICH IS ON THE 5972 04:01:54,111 --> 04:01:55,145 NATIONAL LIBRARY OF MEDICINE. 5973 04:01:55,145 --> 04:01:57,848 IT'S PERIODICALLY UPDATED, 5974 04:01:57,848 --> 04:01:59,282 BASICALLY INCLUDES CONSENSUS 5975 04:01:59,282 --> 04:02:01,151 DEFINITIONS IN THE BIOMARKER 5976 04:02:01,151 --> 04:02:02,819 SPACE, AND THERE'S OTHER 5977 04:02:02,819 --> 04:02:03,720 ANCILLARY INFORMATION THERE THAT 5978 04:02:03,720 --> 04:02:04,821 I THINK IS VERY HELPFUL. 5979 04:02:04,821 --> 04:02:06,189 SO I JUST WANTED TO HIGHLIGHT 5980 04:02:06,189 --> 04:02:08,825 FOR THOSE THAT MIGHT NOT BE 5981 04:02:08,825 --> 04:02:10,594 AWARE. 5982 04:02:10,594 --> 04:02:11,561 WHAT'S UNIQUE ABOUT THE 5983 04:02:11,561 --> 04:02:12,963 REGULATORY ASPECT OF BIOMARKERS 5984 04:02:12,963 --> 04:02:16,399 IS THAT ALTHOUGH BIOMARKERS ARE 5985 04:02:16,399 --> 04:02:18,068 USED BY MANY DIFFERENT 5986 04:02:18,068 --> 04:02:19,569 COMMUNITIES INCLUDING CLINICAL 5987 04:02:19,569 --> 04:02:21,338 AND BASIC SCIENCE AND THE LIKE, 5988 04:02:21,338 --> 04:02:21,972 WHEN YOU TALK ABOUT THE 5989 04:02:21,972 --> 04:02:23,373 INCLUSION OF BIOMARKER 5990 04:02:23,373 --> 04:02:26,843 INFORMATION IN A DRUG PROGRAM, 5991 04:02:26,843 --> 04:02:28,512 WHETHER OR NOT IT'S 5992 04:02:28,512 --> 04:02:29,746 REGULATORY-READY, QUOTE-UNQUOTE, 5993 04:02:29,746 --> 04:02:31,047 THERE ARE KIND OF THREE CORE 5994 04:02:31,047 --> 04:02:32,315 FACTORS THAT COME INTO PLAY. 5995 04:02:32,315 --> 04:02:33,650 ONE IS AROUND THE 5996 04:02:33,650 --> 04:02:35,919 REPRODUCIBILITY OF THE DATA, AND 5997 04:02:35,919 --> 04:02:39,222 THAT ULTIMATELY SCIENCE IS A 5998 04:02:39,222 --> 04:02:40,257 COLLABORATIVE PROCESS, AND 5999 04:02:40,257 --> 04:02:42,092 ULTIMATELY YOU START FROM THE 6000 04:02:42,092 --> 04:02:43,293 PUBLISHED SCIENTIFIC LITERATURE, 6001 04:02:43,293 --> 04:02:46,129 AT LEAST THAT'S WHAT MOST FOLKS 6002 04:02:46,129 --> 04:02:46,296 DO. 6003 04:02:46,296 --> 04:02:50,000 THAT LITERATURE, YOU KNOW, HAS 6004 04:02:50,000 --> 04:02:51,835 ITS VALUE BUT THERE ARE ALSO 6005 04:02:51,835 --> 04:02:52,636 CHALLENGES IN THAT THERE'S A 6006 04:02:52,636 --> 04:02:53,937 HIGH RATE OF DISCORDANT 6007 04:02:53,937 --> 04:02:58,542 INFORMATION IN THE LITERATURE 6008 04:02:58,542 --> 04:02:59,743 AROUND BIOMARKER DATA. 6009 04:02:59,743 --> 04:03:02,245 MUCH OF THAT COMES FROM NOT 6010 04:03:02,245 --> 04:03:03,780 NECESSARILY THAT ANY GIVEN LAB 6011 04:03:03,780 --> 04:03:05,315 HAD DONE SOMETHING RIGHT OR DONE 6012 04:03:05,315 --> 04:03:07,284 SOMETHING WRONG, BUT EACH DID SO 6013 04:03:07,284 --> 04:03:10,487 DIFFERENTLY, AND THE METHOD 6014 04:03:10,487 --> 04:03:11,888 SECTION OF SCIENTIFIC 6015 04:03:11,888 --> 04:03:13,223 PUBLICATIONS ARE USUALLY NOT 6016 04:03:13,223 --> 04:03:15,625 SPECIFIC ENOUGH TO KIND OF DO 6017 04:03:15,625 --> 04:03:16,726 METADATA ANALYSIS ACROSS STUDIES 6018 04:03:16,726 --> 04:03:18,395 AND THE LIKE. 6019 04:03:18,395 --> 04:03:19,830 AND ONE OF THOSE MAIN PROBLEMS 6020 04:03:19,830 --> 04:03:21,765 IS AROUND THE USE OF THE 6021 04:03:21,765 --> 04:03:23,834 MEASUREMENT METHOD OR THE 6022 04:03:23,834 --> 04:03:24,501 ANALYTIC, ESPECIALLY FOR ANY 6023 04:03:24,501 --> 04:03:27,137 TYPE OF A NOVEL BIOMARKER, 6024 04:03:27,137 --> 04:03:28,672 THERE'S LIKELY NOT AN EXISTING 6025 04:03:28,672 --> 04:03:30,974 ASSAY OR DEVICE, SO THESE ARE 6026 04:03:30,974 --> 04:03:32,843 BEING HOME-GROWN IN THE LABS 6027 04:03:32,843 --> 04:03:34,845 WHERE THESE ARE BEING STUDIED, 6028 04:03:34,845 --> 04:03:37,814 WHICH IS PERFECTLY FINE, BUT AS 6029 04:03:37,814 --> 04:03:40,684 THAT MATURES, THE ANALYTIC 6030 04:03:40,684 --> 04:03:41,251 PERFORMANCE CHARACTERISTICS 6031 04:03:41,251 --> 04:03:45,922 BECOME MORE AND MORE IMPORTANT, 6032 04:03:45,922 --> 04:03:46,990 AND IT'S ALWAYS A CHICKEN AND 6033 04:03:46,990 --> 04:03:48,225 EGG PROBLEM, HOW MUCH DO YOU 6034 04:03:48,225 --> 04:03:49,559 INVEST IN THE PERFORMANCE OF 6035 04:03:49,559 --> 04:03:50,760 YOUR ANALYTIC WHEN YOU DON'T 6036 04:03:50,760 --> 04:03:52,262 KNOW IF THE BIOMARKER IS 6037 04:03:52,262 --> 04:03:55,365 VALUABLE OR NOT. 6038 04:03:55,365 --> 04:03:56,666 SO THAT IS KIND OF ONE OF THE 6039 04:03:56,666 --> 04:03:57,033 CHALLENGES. 6040 04:03:57,033 --> 04:03:59,870 THE OTHER IS THAT CERTAINLY AS 6041 04:03:59,870 --> 04:04:01,905 TECHNOLOGY BECOMES MORE COMPLEX 6042 04:04:01,905 --> 04:04:05,442 AND INNOVATIVE, IT ALSO BECOMES 6043 04:04:05,442 --> 04:04:11,047 LESS PORTABLE, IF YOU WILL, ANDT 6044 04:04:11,047 --> 04:04:14,417 FROM A BIOMARKER DEVELOPMENT 6045 04:04:14,417 --> 04:04:15,018 PERSPECTIVE IS WHETHER OR NOT 6046 04:04:15,018 --> 04:04:16,920 IT'S GOING TO BE USED IN A DRUG 6047 04:04:16,920 --> 04:04:18,622 PROGRAM AND ULTIMATELY LEAD TO 6048 04:04:18,622 --> 04:04:21,024 THAT DRUG'S APPROVAL, WILL THAT 6049 04:04:21,024 --> 04:04:21,825 TECHNOLOGY IN FACT BE AVAILABLE 6050 04:04:21,825 --> 04:04:23,360 FOR PRESCRIBERS SO THEY CAN 6051 04:04:23,360 --> 04:04:24,294 ULTIMATELY DECIDE WHETHER OR NOT 6052 04:04:24,294 --> 04:04:25,729 A GIVEN PATIENT SHOULD OR SHOULD 6053 04:04:25,729 --> 04:04:28,665 NOT GO ON A THERAPY. 6054 04:04:28,665 --> 04:04:29,633 AND THE WAY TO DO THAT, IF 6055 04:04:29,633 --> 04:04:31,001 THERE'S A BIOMARKER SELECTION OR 6056 04:04:31,001 --> 04:04:32,435 ROLE IN THAT DEVELOPMENT EFFORT 6057 04:04:32,435 --> 04:04:33,737 IS WHETHER OR NOT THAT TEST IS 6058 04:04:33,737 --> 04:04:35,171 ALSO AVAILABLE. 6059 04:04:35,171 --> 04:04:37,140 OR SOMETHING THAT'S AT LEAST 6060 04:04:37,140 --> 04:04:40,977 PERFORMING TO THE SAME STANDARD. 6061 04:04:40,977 --> 04:04:42,412 WHEN YOU'RE DOING COLLABORATIVE 6062 04:04:42,412 --> 04:04:43,747 EFFORT AROUND BIOMARKERS, I LIKE 6063 04:04:43,747 --> 04:04:46,683 TO THINK ABOUT THIS VERY SIMPLY. 6064 04:04:46,683 --> 04:04:48,852 ULTIMATELY SCIENCE AND MEDICINE 6065 04:04:48,852 --> 04:04:52,188 TO A LARGE DEGREE IS MORE OF AN 6066 04:04:52,188 --> 04:04:52,856 ART THAN A SCIENCE. 6067 04:04:52,856 --> 04:04:55,458 WE CERTAINLY KNOW WHAT WE KNOW, 6068 04:04:55,458 --> 04:04:58,795 BUT WHEN YOU'RE PUTTING TOGETHER 6069 04:04:58,795 --> 04:05:00,063 A CLINICAL PROGRAM, I THINK IT'S 6070 04:05:00,063 --> 04:05:01,331 REALLY HELPFUL TO ARTICULATE 6071 04:05:01,331 --> 04:05:03,233 WHAT ARE YOUR ASSUMPTIONS GOING 6072 04:05:03,233 --> 04:05:04,034 INTO THAT, ESPECIALLY AROUND 6073 04:05:04,034 --> 04:05:06,770 SOME OF THE KEY ASPECTS OF THE 6074 04:05:06,770 --> 04:05:08,939 CLINICAL TRIAL AND THAT COULD 6075 04:05:08,939 --> 04:05:10,473 INCLUDE THE BIOMARKER ITSELF, 6076 04:05:10,473 --> 04:05:11,474 METHOD OF MEASUREMENT, WHAT 6077 04:05:11,474 --> 04:05:13,343 POPULATION IS BEING ENROLLED AND 6078 04:05:13,343 --> 04:05:14,244 ALSO THE END POINT. 6079 04:05:14,244 --> 04:05:15,412 AND I THINK IF YOU CAN 6080 04:05:15,412 --> 04:05:18,048 ARTICULATE IN ADVANCE WHERE YOUR 6081 04:05:18,048 --> 04:05:19,582 ASSUMPTIONS LIE, IF THINGS DON'T 6082 04:05:19,582 --> 04:05:23,653 GO AS YOU HAD PLANNED, WHICH 6083 04:05:23,653 --> 04:05:24,521 UNFORTUNATELY HAPPENS MORE OFTEN 6084 04:05:24,521 --> 04:05:27,390 THAN NOT, IT ALLOWS YOU TO LEARN 6085 04:05:27,390 --> 04:05:30,226 FROM THOSE NEGATIVE RESULTS IN A 6086 04:05:30,226 --> 04:05:31,594 WAY, BUT IT'S DIFFICULT WHEN 6087 04:05:31,594 --> 04:05:32,929 THINGS DIDN'T GO WELL AND IF YOU 6088 04:05:32,929 --> 04:05:34,097 DO THAT SORT OF PRE-PLANNING, 6089 04:05:34,097 --> 04:05:36,933 THEN IT'S VERY EASY TO GET INTO 6090 04:05:36,933 --> 04:05:38,568 THESE POST HOC ANALYSES WHICH 6091 04:05:38,568 --> 04:05:40,337 KIND OF GO DOWN RABBIT HOLES AND 6092 04:05:40,337 --> 04:05:43,173 KIND OF UNDERMINE WHAT YOU COULD 6093 04:05:43,173 --> 04:05:44,708 HAVE LEARNED FROM THOSE NEGATIVE 6094 04:05:44,708 --> 04:05:44,941 RESULTS. 6095 04:05:44,941 --> 04:05:46,376 SO IN GENERAL, I WOULD SAY AS 6096 04:05:46,376 --> 04:05:47,644 YOU START ANY OF THESE EFFORTS, 6097 04:05:47,644 --> 04:05:49,412 WHATEVER THAT EFFORT MAY BE, 6098 04:05:49,412 --> 04:05:51,514 JUST TAKE THE TIME TO PUT IN THE 6099 04:05:51,514 --> 04:05:55,819 EFFORT UP FRONT AROUND THE CORE 6100 04:05:55,819 --> 04:05:56,820 ELEMENTS AND WHAT YOU KNOW, WHAT 6101 04:05:56,820 --> 04:05:58,254 YOU THINK YOU KNOW, AND WHAT YOU 6102 04:05:58,254 --> 04:05:59,656 NEED TO KNOW IN ORDER FOR THIS 6103 04:05:59,656 --> 04:06:04,861 TO BE HELPFUL IN THE FUTURE. 6104 04:06:04,861 --> 04:06:06,296 IT'S HELPFUL AROUND A BIOMARKER 6105 04:06:06,296 --> 04:06:07,897 TO TALK ABOUT ITS CONTEXT OF 6106 04:06:07,897 --> 04:06:08,064 USE. 6107 04:06:08,064 --> 04:06:09,766 THE EXAMPLES THAT ARE GIVEN HERE 6108 04:06:09,766 --> 04:06:12,402 ARE FROM A CLINICAL TRIAL 6109 04:06:12,402 --> 04:06:14,137 PERSPECTIVE, BUT THESE COULD BE 6110 04:06:14,137 --> 04:06:15,805 MODIFIED FOR WHATEVER YOUR USE 6111 04:06:15,805 --> 04:06:16,673 MAY BE. 6112 04:06:16,673 --> 04:06:21,111 MANY OF THE USE CASES INVOLVE 6113 04:06:21,111 --> 04:06:21,978 IDENTIFYING THE RIGHT PATIENT 6114 04:06:21,978 --> 04:06:22,912 POPULATION THAT YOU WANT TO 6115 04:06:22,912 --> 04:06:24,114 ENROLL IN YOUR STUDY. 6116 04:06:24,114 --> 04:06:25,415 AS WAS MENTIONED BY SOME OF THE 6117 04:06:25,415 --> 04:06:26,750 PREVIOUS PRESENTERS, MANY 6118 04:06:26,750 --> 04:06:29,819 DISEASE ENTITIES HAVE A 6119 04:06:29,819 --> 04:06:31,454 HETEROGENEITY PROBLEM, SO ONE OF 6120 04:06:31,454 --> 04:06:34,357 THE THINGS YOU CAN DO WITH THE 6121 04:06:34,357 --> 04:06:36,526 BIOMARKER DATA IS TO HELP TO 6122 04:06:36,526 --> 04:06:37,494 HOMOGENIZE THE PATIENTS THAT ARE 6123 04:06:37,494 --> 04:06:38,862 ENROLLED SO THEY'RE MORE SIMILAR 6124 04:06:38,862 --> 04:06:40,063 THAN DISSIMILAR, AT LEAST AS A 6125 04:06:40,063 --> 04:06:43,466 PROOF OF CONCEPT SO THAT YOU CAN 6126 04:06:43,466 --> 04:06:45,468 KIND OF BUILD FROM THERE. 6127 04:06:45,468 --> 04:06:50,940 IT A BIT OF A KIND OF 6128 04:06:50,940 --> 04:06:52,776 INTERESTING CONVERSATION WITH 6129 04:06:52,776 --> 04:06:54,277 THE AGENCY. 6130 04:06:54,277 --> 04:06:54,978 ULTIMATELY THEY WANT A DRUG TO 6131 04:06:54,978 --> 04:06:56,846 BE STUDIED IN AS BROAD A 6132 04:06:56,846 --> 04:06:59,783 POPULATION AS POSSIBLE. 6133 04:06:59,783 --> 04:07:02,118 BUT I THINK IN THE EARLY PROOF 6134 04:07:02,118 --> 04:07:03,186 OF CONCEPT STAGE, THEY'RE 6135 04:07:03,186 --> 04:07:04,854 CERTAINLY OPEN TO HAVING A MORE 6136 04:07:04,854 --> 04:07:06,389 HOMOGENEOUS POPULATION TO AT 6137 04:07:06,389 --> 04:07:07,690 LEAST IDENTIFY THE PROOF OF 6138 04:07:07,690 --> 04:07:08,792 CONCEPT, AND THEN YOU CAN EXPAND 6139 04:07:08,792 --> 04:07:13,063 FROM THERE. 6140 04:07:13,063 --> 04:07:15,265 WHEN YOU WANT TO VALIDATE A 6141 04:07:15,265 --> 04:07:16,699 BIOMARKER, ULTIMATELY IT'S THE 6142 04:07:16,699 --> 04:07:19,202 BENEFIT AND RISK OF HOW THAT 6143 04:07:19,202 --> 04:07:20,503 BIOMARKER IS USED IN A CLINICAL 6144 04:07:20,503 --> 04:07:21,371 TRIAL CONTEXT THAT DETERMINES 6145 04:07:21,371 --> 04:07:22,939 WHAT TYPE OF DATA IS NEEDED TO 6146 04:07:22,939 --> 04:07:25,408 SUPPORT THAT USE. 6147 04:07:25,408 --> 04:07:26,810 AND ESSENTIALS FOR A VALIDATION 6148 04:07:26,810 --> 04:07:29,412 EFFORT IS AGAIN THE SPECIFICITY 6149 04:07:29,412 --> 04:07:30,814 OF THE BIOMARKER DEFINE WHAT YOU 6150 04:07:30,814 --> 04:07:32,282 MEAN BY THE BIOMARKER IN GREAT 6151 04:07:32,282 --> 04:07:35,452 DETAIL, AND THERE'S RESOURCES 6152 04:07:35,452 --> 04:07:38,955 AVAILABLE ON BEST THAT TALK 6153 04:07:38,955 --> 04:07:39,556 ABOUT THE DIFFERENT COMPONENTS 6154 04:07:39,556 --> 04:07:40,857 OF A BIOMARKER DESCRIPTION. 6155 04:07:40,857 --> 04:07:44,060 YOU WANT TO SPECIFY THE TOOL OR 6156 04:07:44,060 --> 04:07:45,295 INSTRUMENT AND ULTIMATELY THE 6157 04:07:45,295 --> 04:07:46,629 SETTING IN WHICH IT WOULD BE 6158 04:07:46,629 --> 04:07:47,497 USED AND THEN TRY TO THINK 6159 04:07:47,497 --> 04:07:48,698 THROUGH THE POTENTIAL BENEFITS 6160 04:07:48,698 --> 04:07:54,838 AND RISKS ONE THING TO HIGHLIGHT 6161 04:07:54,838 --> 04:07:56,239 MORE GEARED TOWARDS THE 6162 04:07:56,239 --> 04:07:57,307 RESEARCHERS BUT IT ALSO APPLIES 6163 04:07:57,307 --> 04:07:58,875 TO INDUSTRY, IF THERE'S A 6164 04:07:58,875 --> 04:08:02,612 BIOMARKER AND/OR ASSOCIATED 6165 04:08:02,612 --> 04:08:05,081 MEASUREMENT METHOD OUT THERE, 6166 04:08:05,081 --> 04:08:06,850 AND SORT OF MARKETED IN 6167 04:08:06,850 --> 04:08:08,918 SOMETHING YOU CAN PURCHASE AS A 6168 04:08:08,918 --> 04:08:10,053 KIT OR OTHERWISE DOESN'T MEAN 6169 04:08:10,053 --> 04:08:12,355 THAT IT'S REGULATORY-READY FOR 6170 04:08:12,355 --> 04:08:13,790 USE OUTSIDE OF THE CONTEXT IN 6171 04:08:13,790 --> 04:08:16,693 WHICH IT WAS DEVELOPED. 6172 04:08:16,693 --> 04:08:17,760 SO JUST BECAUSE YOU EITHER HAVE 6173 04:08:17,760 --> 04:08:20,864 A TEST OR A BIOMARKER IN ONE 6174 04:08:20,864 --> 04:08:24,634 POPULATION, HOW IT'S BEING USED 6175 04:08:24,634 --> 04:08:25,835 IN A DIFFERENT DISEASE 6176 04:08:25,835 --> 04:08:26,970 POPULATION OR A DIFFERENT 6177 04:08:26,970 --> 04:08:27,971 CONTEXT DOESN'T MEAN YOU HAVE TO 6178 04:08:27,971 --> 04:08:29,239 START FROM SCRATCH, BUT YOU MAY 6179 04:08:29,239 --> 04:08:31,274 HAVE TO DO SOME ADDITIONAL 6180 04:08:31,274 --> 04:08:32,609 ANALYTIC AND/OR CLINICAL 6181 04:08:32,609 --> 04:08:33,476 VALIDATION TO MAKE SURE THAT 6182 04:08:33,476 --> 04:08:35,478 TEST IS REGULATORY-READY FOR ITS 6183 04:08:35,478 --> 04:08:38,882 NEW INTENDED USE. 6184 04:08:38,882 --> 04:08:39,516 ULTIMATELY WHEN YOU'RE TALKING 6185 04:08:39,516 --> 04:08:42,619 ABOUT A DISEASE AND THE 6186 04:08:42,619 --> 04:08:43,820 BIOMARKERS AND HOW THEY MAY 6187 04:08:43,820 --> 04:08:45,688 INTERPLAY AS PART OF A CLINICAL 6188 04:08:45,688 --> 04:08:46,923 DEVELOPMENT EFFORT, I THINK IT'S 6189 04:08:46,923 --> 04:08:48,925 HELPFUL TO KIND OF GO THROUGH 6190 04:08:48,925 --> 04:08:50,193 QUICKLY A PARADIGM WHERE YOU 6191 04:08:50,193 --> 04:08:52,162 TALK ABOUT A NORMAL PHYSIOLOGY 6192 04:08:52,162 --> 04:08:53,963 THAT CHANGES ULTIMATELY BECOMES 6193 04:08:53,963 --> 04:08:56,366 DEFINED BY A DISEASE THROUGH 6194 04:08:56,366 --> 04:08:58,568 CONSENSUS DEFINITIONS OF SIGNS 6195 04:08:58,568 --> 04:08:59,636 AND SYMPTOMS. 6196 04:08:59,636 --> 04:09:01,204 IF THAT DISEASE IS CHRONIC, IT 6197 04:09:01,204 --> 04:09:02,305 MAY HAVE PERIODS WHERE IT'S 6198 04:09:02,305 --> 04:09:04,174 BEING ACTIVE OR QUIESCENT SO YOU 6199 04:09:04,174 --> 04:09:07,577 MAY WANT TO MONITOR IT, AND ALSO 6200 04:09:07,577 --> 04:09:10,980 IF IT IS CHRONIC AND THERE'S 6201 04:09:10,980 --> 04:09:12,482 LONG-TERM SEQUELAE FROM HAVING 6202 04:09:12,482 --> 04:09:15,685 THAT DISEASE, YOU ALSO WANT TO 6203 04:09:15,685 --> 04:09:17,587 LOOK AT PROGNOSTIC BIOMARKERS 6204 04:09:17,587 --> 04:09:18,521 AROUND FUTURE COMPLICATIONS. 6205 04:09:18,521 --> 04:09:20,123 AND THEN ONCE A THERAPY IS IN 6206 04:09:20,123 --> 04:09:21,090 PLAY, YOU CERTAINLY ARE GOING TO 6207 04:09:21,090 --> 04:09:22,859 WANT TO LOOK AT OFF-TARGET 6208 04:09:22,859 --> 04:09:24,093 EFFECTS FROM A SAFETY 6209 04:09:24,093 --> 04:09:25,028 PERSPECTIVE, YOU'RE GOING TO 6210 04:09:25,028 --> 04:09:26,529 WANT TO SHOW PROOF OF CONCEPT, 6211 04:09:26,529 --> 04:09:28,898 AND THEN ULTIMATELY WHETHER OR 6212 04:09:28,898 --> 04:09:29,866 NOT THERE'S SOMETHING BENEFICIAL 6213 04:09:29,866 --> 04:09:31,534 TO THE PATIENT THAT IS 6214 04:09:31,534 --> 04:09:32,235 CLINICALLY MEANINGFUL. 6215 04:09:32,235 --> 04:09:33,836 ONE AREA OF COLLABORATION THAT I 6216 04:09:33,836 --> 04:09:39,576 WOULD HIGHLIGHT WHERE NIH AND 6217 04:09:39,576 --> 04:09:40,543 OTHER COLLABORATIONS WITH COME 6218 04:09:40,543 --> 04:09:42,212 INTO PLAY IS AROUND THIS NORMAL 6219 04:09:42,212 --> 04:09:43,279 PHYSIOLOGY PIECE. 6220 04:09:43,279 --> 04:09:46,649 SO IF YOU IDENTIFY A BIOMARKER 6221 04:09:46,649 --> 04:09:47,584 OF INTEREST AND YOU WANT TO KNOW 6222 04:09:47,584 --> 04:09:50,320 WHAT IS THE NORMAL VARIATION, 6223 04:09:50,320 --> 04:09:54,424 OUTSIDE OF ANY OTHER IMPACT, 6224 04:09:54,424 --> 04:09:57,794 CERTACERTAINLY OUTSIDE OF A DRUG 6225 04:09:57,794 --> 04:09:58,728 CONTEXT, YOU WANT TO KNOW OVER 6226 04:09:58,728 --> 04:09:59,896 THE COURSE OF A DAY, OVER THE 6227 04:09:59,896 --> 04:10:01,764 COURSE OF GENDER, ETHNICITY, 6228 04:10:01,764 --> 04:10:04,167 WHAT ARE ALL THE FACTORS THAT 6229 04:10:04,167 --> 04:10:05,535 IMPACT WHAT THE NATURAL 6230 04:10:05,535 --> 04:10:06,836 VARIABILITY OF THAT BIOMARKER 6231 04:10:06,836 --> 04:10:10,974 MAY BE. 6232 04:10:10,974 --> 04:10:11,808 MANY TIMES THAT IS ONE OF THE 6233 04:10:11,808 --> 04:10:17,046 STSTUMBLING BLOCKS FOR MANY NOVL 6234 04:10:17,046 --> 04:10:18,014 BIOMARKER DEVELOPMENT EFFORTS 6235 04:10:18,014 --> 04:10:18,881 BECAUSE TO GATHER THAT 6236 04:10:18,881 --> 04:10:20,750 INFORMATION USUALLY TAKES TIME 6237 04:10:20,750 --> 04:10:22,151 AND RESOURCES THAT A GIVEN 6238 04:10:22,151 --> 04:10:25,388 ENTITY DOESN'T HAVE. 6239 04:10:25,388 --> 04:10:28,024 AND SO IT'S THAT TYPE OF NORMAL 6240 04:10:28,024 --> 04:10:34,430 BIOLOGY, WHILE NOT SECTI -- WHIT 6241 04:10:34,430 --> 04:10:37,300 SEXY AND MANY TIMES NOT FUNDED 6242 04:10:37,300 --> 04:10:38,368 IT'S CRITICAL FOR A BIOMARKER 6243 04:10:38,368 --> 04:10:39,535 STUDY TO DETERMINE HEY, IS THE 6244 04:10:39,535 --> 04:10:40,803 CHANGE I'M SEEING ABOVE AND 6245 04:10:40,803 --> 04:10:42,238 BEYOND NORMAL VARIATION, AND 6246 04:10:42,238 --> 04:10:44,507 MORE IMPORTANTLY, IS THAT CHANGE 6247 04:10:44,507 --> 04:10:45,742 ABOVE AND BEYOND NORMAL 6248 04:10:45,742 --> 04:10:47,277 VARIATION MEANINGFUL TO THE 6249 04:10:47,277 --> 04:10:49,078 PATIENT, HOW IS IT BENEFITING 6250 04:10:49,078 --> 04:10:49,679 THEM? 6251 04:10:49,679 --> 04:10:51,247 AND IF YOU DON'T KNOW WHAT THAT 6252 04:10:51,247 --> 04:10:52,348 NORMAL VARIATION IS, IT'S KIND 6253 04:10:52,348 --> 04:10:54,651 OF HARD TO HAVE A USEFUL 6254 04:10:54,651 --> 04:10:58,354 CONVERSATION AROUND IT. 6255 04:10:58,354 --> 04:11:00,356 SO I'M GOING TO END WITH TWO 6256 04:11:00,356 --> 04:11:01,691 SLIDES, JUST BASED ON MY TIME 6257 04:11:01,691 --> 04:11:05,728 WITH THE FDA AND COLLABORATING 6258 04:11:05,728 --> 04:11:07,930 WITH NIH, WITH INDUSTRY, WITH 6259 04:11:07,930 --> 04:11:09,632 SMALL BIOTECH, WITH PATIENT 6260 04:11:09,632 --> 04:11:11,868 GROUPS AND NOW MY ROLE AS A 6261 04:11:11,868 --> 04:11:13,403 PHARMACEUTICAL CONSULTANT WHERE 6262 04:11:13,403 --> 04:11:15,171 THESE COLLABORATIVE EFFORTS ARE 6263 04:11:15,171 --> 04:11:16,406 STILL VERY MUCH IN PLAY. 6264 04:11:16,406 --> 04:11:17,807 THE FIRST IS INADEQUATE AND 6265 04:11:17,807 --> 04:11:18,808 INAPPROPRIATE PLANNING. 6266 04:11:18,808 --> 04:11:21,477 SO ULTIMATELY YOU CAN HAVE THE 6267 04:11:21,477 --> 04:11:22,745 BEST IDEAS BUT IF YOU DON'T HAVE 6268 04:11:22,745 --> 04:11:24,847 THE RESOURCES, TIME OR FUNDING 6269 04:11:24,847 --> 04:11:28,618 TO COMPLETE THAT FULL STUDY, 6270 04:11:28,618 --> 04:11:29,485 REALLY SCALE BACK YOUR EFFORTS 6271 04:11:29,485 --> 04:11:30,853 TO SOMETHING THAT'S ACHIEVABLE 6272 04:11:30,853 --> 04:11:31,854 WITHIN THE RESOURCES AND TIME 6273 04:11:31,854 --> 04:11:35,591 THAT YOU HAVE. 6274 04:11:35,591 --> 04:11:37,627 MANY TIMES I THINK PEOPLE GO IN 6275 04:11:37,627 --> 04:11:38,695 WITH THE BEST INTENTIONS BUT 6276 04:11:38,695 --> 04:11:40,096 THEY DON'T ACHIEVE THEIR GOAL 6277 04:11:40,096 --> 04:11:43,366 AND THEY DON'T ACHIEVE SOMETHING 6278 04:11:43,366 --> 04:11:44,167 AS A MILESTONE BECAUSE THEIR 6279 04:11:44,167 --> 04:11:45,268 GOALS DIDN'T MATCH WHAT THEIR 6280 04:11:45,268 --> 04:11:45,802 OPPORTUNITIES WERE AT THE 6281 04:11:45,802 --> 04:11:49,005 BEGINNING. 6282 04:11:49,005 --> 04:11:50,907 I VERY MUCH WANT TO DO A CALLOUT 6283 04:11:50,907 --> 04:11:52,642 AROUND THE VALIDATION METHOD FOR 6284 04:11:52,642 --> 04:11:54,610 THE BIOMARKER AND HOW YOU'RE 6285 04:11:54,610 --> 04:11:57,680 MEASURING IT AND INTERPRETING 6286 04:11:57,680 --> 04:11:58,448 IT. 6287 04:11:58,448 --> 04:12:00,983 IF THIS ISN'T SOME TYPE OF 6288 04:12:00,983 --> 04:12:02,518 LABORATORY-DEVELOPED TEST OR LDT 6289 04:12:02,518 --> 04:12:04,153 IN A LAB AND YOU'RE DOING YOUR 6290 04:12:04,153 --> 04:12:05,521 BEST AS PART OF AN INITIAL 6291 04:12:05,521 --> 04:12:07,590 BIOMARKER DEVELOPMENT EFFORT, 6292 04:12:07,590 --> 04:12:10,993 JUST ALWAYS BE AWARE THAT ANY 6293 04:12:10,993 --> 04:12:11,961 DECISIONS YOU'RE MAKING BASED ON 6294 04:12:11,961 --> 04:12:13,763 THAT BIOMARKER ARE VERY 6295 04:12:13,763 --> 04:12:15,331 DEPENDENT UPON THE QUALITY OF 6296 04:12:15,331 --> 04:12:17,767 THE ASSAY EMPLOYED. 6297 04:12:17,767 --> 04:12:21,738 AND YOU MAY MAKE DECISIONS THAT 6298 04:12:21,738 --> 04:12:23,573 ARE WRONG JUST BASED ON THE FACT 6299 04:12:23,573 --> 04:12:25,842 THAT THE ANALYTIC METHOD IS NOT 6300 04:12:25,842 --> 04:12:32,682 UP TO THE SPECS NEEDED. 6301 04:12:32,682 --> 04:12:35,084 ALSO JUST BE CAREFUL OF 6302 04:12:35,084 --> 04:12:36,352 OVERINTERPRETING FROM DIFFERENT 6303 04:12:36,352 --> 04:12:37,420 RESOURCES, AS I SAID IN THE 6304 04:12:37,420 --> 04:12:38,888 PUBLISHED LITERATURE, MANY TIMES 6305 04:12:38,888 --> 04:12:41,057 SOME OF THE STUDIES ARE NOT 6306 04:12:41,057 --> 04:12:41,391 REPRODUCIBLE. 6307 04:12:41,391 --> 04:12:42,392 GREAT PLACE TO START BUT NOT 6308 04:12:42,392 --> 04:12:50,533 ALWAYS THE BEST PLACE TO END. 6309 04:12:50,533 --> 04:12:51,134 THERE'S A LOT OF INFORMATION 6310 04:12:51,134 --> 04:12:52,068 THAT'S OUT THERE THAT'S PUBLIC 6311 04:12:52,068 --> 04:12:53,603 FROM A REGULATORY PERSPECTIVE, 6312 04:12:53,603 --> 04:12:55,838 AND IT REALLY WOULD ENCOURAGE 6313 04:12:55,838 --> 04:12:57,240 YOU, WHATEVER YOUR GOALS ARE, TO 6314 04:12:57,240 --> 04:12:59,008 LOOK AT THOSE RESOURCES, BECAUSE 6315 04:12:59,008 --> 04:13:01,310 THEY REALLY ARE QUITE HELPFUL. 6316 04:13:01,310 --> 04:13:02,578 SO IN THE BIOMARKER DEVELOPMENT 6317 04:13:02,578 --> 04:13:04,380 SPACE, BASED ON THE CURES 6318 04:13:04,380 --> 04:13:06,449 LEGISLATION BACK IN 2017, NOW 6319 04:13:06,449 --> 04:13:10,553 THE SUBMISSIONS ARE MADE PUBLIC 6320 04:13:10,553 --> 04:13:11,754 AND FDA'S GUIDANCE AND 6321 04:13:11,754 --> 04:13:12,722 RECOMMENDATIONS ARE ALSO MADE 6322 04:13:12,722 --> 04:13:13,689 PUBLIC. 6323 04:13:13,689 --> 04:13:16,793 AND THE INFORMATION IS IN A 6324 04:13:16,793 --> 04:13:17,460 SEARCHABLE DATABASE, SO WHETHER 6325 04:13:17,460 --> 04:13:19,095 YOU'RE DOING AN IMAGING 6326 04:13:19,095 --> 04:13:20,196 BIOMARKER OR SOMETHING IN THE 6327 04:13:20,196 --> 04:13:22,832 DIGITAL ARENA, WHY NOT LOOK AT 6328 04:13:22,832 --> 04:13:25,568 THE ADVICE THAT OTHER GROUPS ARE 6329 04:13:25,568 --> 04:13:27,203 RECEIVING AND THEN APPLY TO YOUR 6330 04:13:27,203 --> 04:13:30,473 OWN DEVELOPMENT EFFORT. 6331 04:13:30,473 --> 04:13:31,741 EVEN IF YOU HAVE NO DESIRE TO 6332 04:13:31,741 --> 04:13:33,176 INTERFACE WITH FDA, I JUST THINK 6333 04:13:33,176 --> 04:13:35,011 IT'S GOOD SCIENTIFIC PRACTICE 6334 04:13:35,011 --> 04:13:37,580 THAT THESE KIND OF EXCHANGES 6335 04:13:37,580 --> 04:13:39,982 TAKE PLACE AND PEOPLE CONSIDER 6336 04:13:39,982 --> 04:13:41,384 THEM. 6337 04:13:41,384 --> 04:13:42,819 THE SECOND IS CERTAINLY IN THE 6338 04:13:42,819 --> 04:13:44,787 BIOMARKERS, MANY FOLKS ARE 6339 04:13:44,787 --> 04:13:47,890 TRYING TO GET DRUGS TO PATIENTS 6340 04:13:47,890 --> 04:13:49,125 FASTER, ESPECIALLY WHEN THEY 6341 04:13:49,125 --> 04:13:50,993 DON'T HAVE EXISTING THERAPY OR 6342 04:13:50,993 --> 04:13:52,061 INADEQUATE THERAPY AND THEY'RE 6343 04:13:52,061 --> 04:13:54,263 LOOKING AT NOVEL SURROGATES AND 6344 04:13:54,263 --> 04:13:55,698 THERE'S AN OPPORTUNITY TO LOOK 6345 04:13:55,698 --> 04:13:57,300 AT THOSE RESOURCES TO SEE, HEY, 6346 04:13:57,300 --> 04:14:00,002 AM I HITTING ALL OF THE RELEVANT 6347 04:14:00,002 --> 04:14:02,538 AREAS THAT AT LEAST A REGULATOR 6348 04:14:02,538 --> 04:14:03,439 IS CONCERNED ABOUT? 6349 04:14:03,439 --> 04:14:04,841 FINAL WILL BE AROUND DATA 6350 04:14:04,841 --> 04:14:05,641 MANAGEMENT. 6351 04:14:05,641 --> 04:14:07,677 MAKE SURE YOU TRY TO PRESPECIFY 6352 04:14:07,677 --> 04:14:09,345 YOUR PROTOCOLS, YOUR S.O.P.s 6353 04:14:09,345 --> 04:14:10,580 AND DOCUMENT SO THAT ULTIMATELY 6354 04:14:10,580 --> 04:14:12,849 IF THERE'S A QUESTION ON THE 6355 04:14:12,849 --> 04:14:14,784 DATA ITSELF OR EVEN BETWEEN 6356 04:14:14,784 --> 04:14:15,751 LABS, YOU CAN KIND OF GO BACK 6357 04:14:15,751 --> 04:14:17,186 AND SEE WHERE THE PROBLEMS MAY 6358 04:14:17,186 --> 04:14:17,954 HAVE ARISEN. 6359 04:14:17,954 --> 04:14:20,857 THE OTHER THING I WOULD 6360 04:14:20,857 --> 04:14:22,692 ENCOURAGE, AND THIS IS FOR THE 6361 04:14:22,692 --> 04:14:24,827 LONGITUDINAL EFFORTS AROUND 6362 04:14:24,827 --> 04:14:26,529 NATURAL HISTORY STUDIES AND THE 6363 04:14:26,529 --> 04:14:27,597 LIKE, REALLY GO OUT OF YOUR WAY 6364 04:14:27,597 --> 04:14:28,998 TO MAKE SURE THAT YOU'RE USING 6365 04:14:28,998 --> 04:14:30,132 CASE DEFINITIONS FOR THE DISEASE 6366 04:14:30,132 --> 04:14:31,467 THAT ARE BROADLY ACCEPTED AND 6367 04:14:31,467 --> 04:14:33,970 THAT YOU'RE USING DATA STANDARDS 6368 04:14:33,970 --> 04:14:36,939 WHEN THEY EXIST. 6369 04:14:36,939 --> 04:14:40,476 ONE OF THE BIGGEST CHALLENGES AT 6370 04:14:40,476 --> 04:14:41,811 LEAST THAT WE HAD AT THE FDA 6371 04:14:41,811 --> 04:14:43,746 WHEN TRYING TO FIND WHAT IS THAT 6372 04:14:43,746 --> 04:14:45,014 NATURAL VARIABILITY, WE WOULD GO 6373 04:14:45,014 --> 04:14:46,516 TO NIH WHERE THEY WOULD BE DOING 6374 04:14:46,516 --> 04:14:47,984 THESE DECADES-LONG NATURAL 6375 04:14:47,984 --> 04:14:49,752 HISTORY STUDIES ONLY TO FIND OUT 6376 04:14:49,752 --> 04:14:51,187 THAT WE COULDN'T USE THE DATA 6377 04:14:51,187 --> 04:14:52,388 BECAUSE EITHER THE CASE 6378 04:14:52,388 --> 04:14:53,689 DEFINITION FOR THE DISEASE 6379 04:14:53,689 --> 04:14:54,891 DEPARTMENT MATCH WHAT'S BEING 6380 04:14:54,891 --> 04:14:56,592 DONE IN CLINICAL TRIALS OR THAT 6381 04:14:56,592 --> 04:14:57,693 THE DATA STANDARDS WERE EITHER 6382 04:14:57,693 --> 04:14:59,562 NOT THERE OR DIFFERENT. 6383 04:14:59,562 --> 04:15:01,097 SO IT REALLY IS HELPFUL IF WE 6384 04:15:01,097 --> 04:15:02,632 THINK OF THIS AS A COMMUNITY 6385 04:15:02,632 --> 04:15:03,933 EFFORT, THINK OF NOT ONLY YOUR 6386 04:15:03,933 --> 04:15:05,701 OWN NEEDS, BUT THOSE OF THE 6387 04:15:05,701 --> 04:15:06,536 COMMUNITY, BECAUSE THAT'S GOING 6388 04:15:06,536 --> 04:15:08,371 TO BE CRITICAL FOR ANY TYPE OF 6389 04:15:08,371 --> 04:15:10,339 ADVANCEMENT IN THE FIELD. 6390 04:15:10,339 --> 04:15:14,310 AND THEN FINALLY, WHEN YOU'RE 6391 04:15:14,310 --> 04:15:15,545 DOING YOUR BIOMARKER DEVELOPMENT 6392 04:15:15,545 --> 04:15:17,947 EFFORT, CERTAINLY FOR INVESTORS, 6393 04:15:17,947 --> 04:15:21,384 ALWAYS TO SAY WHY YOU'RE NEW, 6394 04:15:21,384 --> 04:15:24,754 WHILE YOU'RE NOVEL, THE EXACT 6395 04:15:24,754 --> 04:15:26,622 OPPOSITE, WHAT MAKES MY PROJECT 6396 04:15:26,622 --> 04:15:27,490 SIMILAR TO OTHERS RATHER THAN 6397 04:15:27,490 --> 04:15:28,491 WHAT MAKES IT DIFFERENT. 6398 04:15:28,491 --> 04:15:30,793 IN ALL SERIOUS ANY, YOUR IDEA 6399 04:15:30,793 --> 04:15:32,762 MAY NOT BE ALL THAT SPECIAL AND 6400 04:15:32,762 --> 04:15:33,863 THAT'S A GOOD THING, NOT 6401 04:15:33,863 --> 04:15:35,164 NECESSARILY A BAD THING. 6402 04:15:35,164 --> 04:15:36,098 AND WITH THAT, I LOOK FORWARD TO 6403 04:15:36,098 --> 04:15:37,166 YOUR QUESTIONS. 6404 04:15:37,166 --> 04:15:37,433 >> GREAT. 6405 04:15:37,433 --> 04:15:44,040 THANK YOU SO MUCH, DR. LEPTAK, 6406 04:15:44,040 --> 04:15:45,675 FOR A WONDERFUL PRESENTATION AND 6407 04:15:45,675 --> 04:15:47,009 ALL OUR PANELISTS FOR SHARING 6408 04:15:47,009 --> 04:15:53,916 THEIR WISDOM AND INSIGHT. 6409 04:15:53,916 --> 04:15:56,953 AS WE REFER TO A QUESTION, I 6410 04:15:56,953 --> 04:15:58,187 THINK WE'LL START OUT AND I'LL 6411 04:15:58,187 --> 04:15:59,689 ASK EACH OF OUR PANELISTS TO 6412 04:15:59,689 --> 04:16:03,125 SORT OF ANSWER, MAYBE WITH A 6413 04:16:03,125 --> 04:16:05,995 ONE-LINER, A GENERAL QUESTION 6414 04:16:05,995 --> 04:16:07,563 THAT WHAT CAN BE DONE TO IMPROVE 6415 04:16:07,563 --> 04:16:09,298 THE PROCESS OF BUILDING A 6416 04:16:09,298 --> 04:16:12,401 PARTNERSHIP BETWEEN NIH, IRB AND 6417 04:16:12,401 --> 04:16:13,269 INDUSTRY, WHAT WOULD BE ONE 6418 04:16:13,269 --> 04:16:15,671 THING THAT YOU MAY SUGGEST OR 6419 04:16:15,671 --> 04:16:18,107 ONE THING THAT WE SHOULD FOCUS 6420 04:16:18,107 --> 04:16:19,742 ON FROM THE NIH SIDE OR THE 6421 04:16:19,742 --> 04:16:20,309 INDUSTRY SIDE? 6422 04:16:20,309 --> 04:16:21,844 SO I'LL START WITH RICHARD AND 6423 04:16:21,844 --> 04:16:23,279 THEN KIND OF GO DOWN HOW WE 6424 04:16:23,279 --> 04:16:28,250 PRESENTED. 6425 04:16:28,250 --> 04:16:29,652 >> SURE, THANKS. 6426 04:16:29,652 --> 04:16:31,120 I THINK ONE THING IS JUST 6427 04:16:31,120 --> 04:16:34,423 AWARENESS FROM THE NIH SIDE, BUT 6428 04:16:34,423 --> 04:16:36,892 MY COLLEAGUES AT LEAST AT KNOW 6429 04:16:36,892 --> 04:16:39,695 NOVARTIS, THERE WASN'T UNIVERSAL 6430 04:16:39,695 --> 04:16:41,230 KNOWLEDGE OF THE NIH CLINICAL 6431 04:16:41,230 --> 04:16:42,431 CENTER AND THE TYPES OF DISEASE 6432 04:16:42,431 --> 04:16:44,066 THAT ARE STUDIED AND HOW 6433 04:16:44,066 --> 04:16:44,634 COLLABORATIONS COULD GO. 6434 04:16:44,634 --> 04:16:46,302 I THINK ON THE NIH SIDE, THE KEY 6435 04:16:46,302 --> 04:16:49,505 THING FOR ME, AND IT CAME UP IN 6436 04:16:49,505 --> 04:16:50,139 ONE OF THE QUESTIONS, IS JUST 6437 04:16:50,139 --> 04:16:51,374 TRYING TO HAVE THE TYPES OF 6438 04:16:51,374 --> 04:16:53,142 AGREEMENTS A LITTLE BIT MORE IN 6439 04:16:53,142 --> 04:16:54,710 LINE WITH THE REST OF THE WORLD. 6440 04:16:54,710 --> 04:16:57,246 SO NIH, I THINK AS FAR AS I CAN 6441 04:16:57,246 --> 04:16:59,382 TELL, IS TRULY UNIQUE, WHICH IS 6442 04:16:59,382 --> 04:17:00,750 NOT A GOOD THING, IN TERMS OF 6443 04:17:00,750 --> 04:17:02,318 CRADAs AND CLINICAL TRIAL 6444 04:17:02,318 --> 04:17:03,185 AGREEMENTS. 6445 04:17:03,185 --> 04:17:04,654 AND THEN -- SO TRYING TO 6446 04:17:04,654 --> 04:17:09,258 HARMONIZE A LITTLE BETTER WOULD 6447 04:17:09,258 --> 04:17:10,326 I THINK GO A LONG WAY. 6448 04:17:10,326 --> 04:17:11,861 >> THANK YOU, RICHARD. 6449 04:17:11,861 --> 04:17:12,061 SEAN? 6450 04:17:12,061 --> 04:17:13,763 >> I'M TELLING YOU, I CANNOT 6451 04:17:13,763 --> 04:17:18,234 AGREE WITH YOU MORE. 6452 04:17:18,234 --> 04:17:25,341 EVEN WITHIN THE NIH, DIFFERENT 6453 04:17:25,341 --> 04:17:28,477 INSTITUTES HAVE JUST -- THEIR 6454 04:17:28,477 --> 04:17:29,145 APPROACH COULD BE A LITTLE 6455 04:17:29,145 --> 04:17:29,712 DIFFERENT. 6456 04:17:29,712 --> 04:17:33,949 AS AN NIH INVESTIGATOR, YOU 6457 04:17:33,949 --> 04:17:37,553 ALMOST COME WITH THAT IDEA IN 6458 04:17:37,553 --> 04:17:38,087 MIND. 6459 04:17:38,087 --> 04:17:40,022 WE PARTNERED WITH CARE DX, ONE 6460 04:17:40,022 --> 04:17:43,292 OF THE COMPANIES THAT WORK ON 6461 04:17:43,292 --> 04:17:43,826 CELL FREE DNA. 6462 04:17:43,826 --> 04:17:47,730 IT IS GREAT THAT WE BUILD 6463 04:17:47,730 --> 04:17:48,731 RELATIONSHIPS, SO SOMETIMES YOU 6464 04:17:48,731 --> 04:17:51,767 SEE THEM LITERALLY HITTING THEIR 6465 04:17:51,767 --> 04:17:56,772 HEAD ON THE WALL, AND I THINK 6466 04:17:56,772 --> 04:17:57,273 OUR REGULATIONS FOLLOW 6467 04:17:57,273 --> 04:17:58,941 GOVERNMENT RULES. 6468 04:17:58,941 --> 04:18:00,142 IT LITERALLY TAKES AN ACT OF 6469 04:18:00,142 --> 04:18:01,977 CONGRESS TO CHANGE THEM. 6470 04:18:01,977 --> 04:18:04,346 BUT YOUR POINT IS WELL TAKEN, 6471 04:18:04,346 --> 04:18:08,784 THAT OUR RULES NEED TO SOMEHOW 6472 04:18:08,784 --> 04:18:10,286 ALIGN WITH THE REST OF THE WORLD 6473 04:18:10,286 --> 04:18:11,754 AND IT DELAYS OUR PARTNERSHIP 6474 04:18:11,754 --> 04:18:13,022 WITH INDUSTRY, I COULD NOT AGREE 6475 04:18:13,022 --> 04:18:13,222 MORE. 6476 04:18:13,222 --> 04:18:14,390 >> I THINK THERE'S A QUESTION 6477 04:18:14,390 --> 04:18:16,325 RELATED TO THAT SPECIFIC POINT, 6478 04:18:16,325 --> 04:18:17,259 BUT WE'LL COME TO THAT A LITTLE 6479 04:18:17,259 --> 04:18:18,994 BIT LATER AND MAYBE I'LL ASK 6480 04:18:18,994 --> 04:18:23,733 RICHARD IF HE CAN ANSWER THAT. 6481 04:18:23,733 --> 04:18:25,367 BUT MOHAN, DO YOU HAVE ANY 6482 04:18:25,367 --> 04:18:26,569 INSIGHT OR ANYTHING YOU WOULD 6483 04:18:26,569 --> 04:18:28,137 SAY, ONE THING THAT WE CAN 6484 04:18:28,137 --> 04:18:28,370 CHANGE? 6485 04:18:28,370 --> 04:18:32,608 >> ABSOLUTELY, DR. HASNI. 6486 04:18:32,608 --> 04:18:34,376 FROM MY PERSPECTIVE, IT'S HOW DO 6487 04:18:34,376 --> 04:18:36,278 WE MAKE THIS MORE 6488 04:18:36,278 --> 04:18:37,379 BUSINESS-FRIENDLY, RIGHT, 6489 04:18:37,379 --> 04:18:39,882 PARTICULARLY FOR STARTUPS. 6490 04:18:39,882 --> 04:18:42,752 AND AGAIN, THEY HAVE UNIQUE 6491 04:18:42,752 --> 04:18:45,955 CHALLENGES IN EVERYTHING FROM 6492 04:18:45,955 --> 04:18:47,389 FUNDING TO DEALING WITH SYSTEMS 6493 04:18:47,389 --> 04:18:48,524 AND VARIOUS OTHER 6494 04:18:48,524 --> 04:18:49,158 CONSIDERATIONS. 6495 04:18:49,158 --> 04:18:50,693 AND THAT WOULD BE MY SUGGESTION, 6496 04:18:50,693 --> 04:18:51,827 ANYTHING THAT WE CAN DO TO 6497 04:18:51,827 --> 04:18:58,400 GETTING THOSE PROCESSES WHEN IN 6498 04:18:58,400 --> 04:19:00,169 DOUBT, THAT WOULD BE GREAT. 6499 04:19:00,169 --> 04:19:00,770 GLL PETER, ANYTHING FROM YOUR 6500 04:19:00,770 --> 04:19:01,137 SIDE? 6501 04:19:01,137 --> 04:19:02,404 >> I THINK I HEARD THIS EARLIER, 6502 04:19:02,404 --> 04:19:05,007 BUT I WAS EXTRAMURAL BEFORE I 6503 04:19:05,007 --> 04:19:08,344 CAME TO NIH, AND I HAD DEVELOPED 6504 04:19:08,344 --> 04:19:11,380 A TECHNOLOGY, AND WHEN I APPLIED 6505 04:19:11,380 --> 04:19:13,382 TO A TOP UNIVERSITY, THEY WERE 6506 04:19:13,382 --> 04:19:15,017 GOING TO SPIN A COMPANY, AND SO 6507 04:19:15,017 --> 04:19:19,722 I THINK IT'S THAT -- WE DON'T 6508 04:19:19,722 --> 04:19:21,924 HAVE THAT DNA AT NIH SO MUCH, 6509 04:19:21,924 --> 04:19:27,096 THAT, YOU KNOW, WE'RE MORE INTO 6510 04:19:27,096 --> 04:19:27,997 RESEARCH AND NOT REALLY PUSHING 6511 04:19:27,997 --> 04:19:30,833 IT OUT THE DOOR, THE REAL TEST, 6512 04:19:30,833 --> 04:19:32,301 AND I THINK THERE'S SO MANY 6513 04:19:32,301 --> 04:19:34,603 BARRIERS TO EVEN -- LEGALLY, YOU 6514 04:19:34,603 --> 04:19:35,137 CAN'T DO THAT. 6515 04:19:35,137 --> 04:19:37,773 SO I'LL STOP THERE. 6516 04:19:37,773 --> 04:19:38,374 >> THANK YOU. 6517 04:19:38,374 --> 04:19:40,943 CHRIS, DO YOU HAVE ANY ONE-LINER 6518 04:19:40,943 --> 04:19:41,177 ADVICE? 6519 04:19:41,177 --> 04:19:42,912 >> YEAH, I WOULD SAY -- I WOULD 6520 04:19:42,912 --> 04:19:44,246 ECHO WHAT I HAD SHARED DURING MY 6521 04:19:44,246 --> 04:19:48,617 TALK, THAT IT'S THE THESE LONGIL 6522 04:19:48,617 --> 04:19:49,518 NATURAL HISTORY STUDIES THAT ARE 6523 04:19:49,518 --> 04:19:50,619 SO IMPORTANT ESPECIALLY IN THE 6524 04:19:50,619 --> 04:19:53,722 RARE DISEASE INTAIS AS SPACE AS 6525 04:19:53,722 --> 04:19:54,590 OTHERS, THAT THOSE TYPE OF 6526 04:19:54,590 --> 04:19:55,825 EFFORTS, MANY TIMES ARE 6527 04:19:55,825 --> 04:19:59,628 SPEARHEADED BY NIH AND ITS 6528 04:19:59,628 --> 04:20:01,130 COMMUNITY, THAT WHEN YOU'RE 6529 04:20:01,130 --> 04:20:01,797 DESIGNING THOSE TRIALS, TO THINK 6530 04:20:01,797 --> 04:20:03,732 BROADLY AND HAVE AS MANY INPUTS 6531 04:20:03,732 --> 04:20:07,236 ON WHAT DATA IS COLLECTED AND 6532 04:20:07,236 --> 04:20:09,071 HOW SO THAT IT HAS THE GREATEST 6533 04:20:09,071 --> 04:20:09,305 UTILITY. 6534 04:20:09,305 --> 04:20:13,542 >> THANK YOU SO MUCH. 6535 04:20:13,542 --> 04:20:14,543 SO THERE ARE A NUMBER OF 6536 04:20:14,543 --> 04:20:15,744 QUESTIONS THERE, I THINK TWO 6537 04:20:15,744 --> 04:20:16,345 QUESTIONS, THE FIRST IS 6538 04:20:16,345 --> 04:20:18,981 SPECIFICALLY FOR RICHARD ABOUT 6539 04:20:18,981 --> 04:20:21,016 HOW SENIOR DO THE PHARMA 6540 04:20:21,016 --> 04:20:22,351 CHAMPIONS HAVE TO BE IN ORDER TO 6541 04:20:22,351 --> 04:20:25,621 MAKE THINGS HAPPEN? 6542 04:20:25,621 --> 04:20:26,755 RICHARD, DO YOU WANT TO RESPOND 6543 04:20:26,755 --> 04:20:27,356 TO THAT? 6544 04:20:27,356 --> 04:20:28,657 >> YEAH, SURE. 6545 04:20:28,657 --> 04:20:29,892 SO I THINK IT REALLY DEPENDS 6546 04:20:29,892 --> 04:20:31,060 WHAT KIND OF AGREEMENT YOU'RE 6547 04:20:31,060 --> 04:20:31,827 TALKING ABOUT. 6548 04:20:31,827 --> 04:20:34,697 IF IT'S AN AGREEMENT WHERE YOUR 6549 04:20:34,697 --> 04:20:36,098 LAB, AN NIH LAB WOULD 6550 04:20:36,098 --> 04:20:38,400 COLLABORATE WITH A RESEARCH 6551 04:20:38,400 --> 04:20:41,904 GROUP AT A COMPANY TO SAY DO 6552 04:20:41,904 --> 04:20:42,872 TRANSLATIONAL RESEARCH ON A 6553 04:20:42,872 --> 04:20:44,707 DISEASE MODEL WITH A TOOL 6554 04:20:44,707 --> 04:20:47,543 COMPOUND, THAT IS A SCIENTIST TO 6555 04:20:47,543 --> 04:20:49,445 SCIENTIST KIND OF BILATERAL 6556 04:20:49,445 --> 04:20:50,579 THING AND IT DOESN'T NEED HIGH 6557 04:20:50,579 --> 04:20:52,815 LEVEL SUPPORT SO THE SCIENTIST 6558 04:20:52,815 --> 04:20:53,816 YOU WOULD BE MEETING WOULD 6559 04:20:53,816 --> 04:20:55,317 LIKELY BE THE SCIENTIST THAT 6560 04:20:55,317 --> 04:20:56,185 WOULD THEN BE THE CHAMPION ON 6561 04:20:56,185 --> 04:20:57,419 THE COMPANY SIDE. 6562 04:20:57,419 --> 04:20:59,922 BUT THE MANAGEMENT GETS INVOLVED 6563 04:20:59,922 --> 04:21:02,024 BUT THAT, I THINK IS MORE 6564 04:21:02,024 --> 04:21:02,324 STREAMLINED. 6565 04:21:02,324 --> 04:21:04,226 FOR THE LARGE CONSORTIA OR FOR 6566 04:21:04,226 --> 04:21:05,327 CLINICAL TRIAL AGREEMENT, THAT'S 6567 04:21:05,327 --> 04:21:07,696 WHERE YOU NEED USUALLY HIGHER 6568 04:21:07,696 --> 04:21:12,701 LEVEL SUPPORT, IF IT'S A 6569 04:21:12,701 --> 04:21:13,702 CONSORTIA, IT'S GREAT BUT THIS 6570 04:21:13,702 --> 04:21:15,304 IS A MULTIMILLION DOLLAR 6571 04:21:15,304 --> 04:21:16,705 COMMITMENT ON THE SIDE OF EACH 6572 04:21:16,705 --> 04:21:17,806 SPONSORING COMPANY, SO THAT JUST 6573 04:21:17,806 --> 04:21:19,942 TAKES A LOT OF TRY ANGULATION, 6574 04:21:19,942 --> 04:21:21,243 HAVING PUSHED ONE OF THOSE 6575 04:21:21,243 --> 04:21:25,147 THROUGH AND THEN THE CLINICAL 6576 04:21:25,147 --> 04:21:26,749 JUST USUALLY TAKES A HIGHER 6577 04:21:26,749 --> 04:21:27,950 LEVEL BECAUSE AS WE'LL MAYBE 6578 04:21:27,950 --> 04:21:29,184 TALK ABOUT, THAT'S ONE OF THE 6579 04:21:29,184 --> 04:21:32,588 HARDEST AGREEMENTS TO GET SIGNED 6580 04:21:32,588 --> 04:21:34,089 WITH NIH INTRAMURAL. 6581 04:21:34,089 --> 04:21:34,823 EXPWR THANK YOU SO MUCH. 6582 04:21:34,823 --> 04:21:35,925 I THINK SOMEBODY COMMENTED FROM 6583 04:21:35,925 --> 04:21:38,427 OUR EARLIER DISCUSSION THAT WE 6584 04:21:38,427 --> 04:21:41,664 HAD, IS THAT -- REDUCE THE SBIR 6585 04:21:41,664 --> 04:21:45,067 GRANT REVIEW TIME, SO ONE OF THE 6586 04:21:45,067 --> 04:21:46,368 THINGS WE CAN DO 6587 04:21:46,368 --> 04:21:46,802 PROGRAMMATICALLY. 6588 04:21:46,802 --> 04:21:47,803 THANK YOU SO MUCH, RICHARD. 6589 04:21:47,803 --> 04:21:49,305 I THINK ONE THING THAT HAS BEEN 6590 04:21:49,305 --> 04:21:51,273 HIGHLIGHTED BOTH FROM NIH SIDE 6591 04:21:51,273 --> 04:21:55,411 AND FROM OUR OUTSIDE INDUSTRY 6592 04:21:55,411 --> 04:21:58,080 PANELISTS IS SOME NIH AGREEMENTS 6593 04:21:58,080 --> 04:21:59,415 OR DOING BUSINESS WITH NIH IS 6594 04:21:59,415 --> 04:22:00,516 NOT INDUSTRY-FRIENDLY. 6595 04:22:00,516 --> 04:22:02,751 AND THERE IS A QUESTION HERE 6596 04:22:02,751 --> 04:22:06,488 WHICH MAYBE I WOULD ASK CHRIS, 6597 04:22:06,488 --> 04:22:08,457 RICHARD AND PERHAPS MOHAN TO 6598 04:22:08,457 --> 04:22:10,292 RESPOND, THAT THERE IS A 6599 04:22:10,292 --> 04:22:11,927 CONSISTENT THEME THAT IT'S NOT 6600 04:22:11,927 --> 04:22:12,895 INDUSTRY-FRIENDLY. 6601 04:22:12,895 --> 04:22:15,764 SO NOW SOMEWHAT FROM -- SOMEONE 6602 04:22:15,764 --> 04:22:18,667 FROM INSIDE NIH IS ASKING WHY 6603 04:22:18,667 --> 04:22:20,069 INDUSTRY AGREEMENTS ARE NOT 6604 04:22:20,069 --> 04:22:27,843 PREPARED IN A MANNER THAT'S -- 6605 04:22:27,843 --> 04:22:29,712 THEY'RE THE SOLE BURDEN OF 6606 04:22:29,712 --> 04:22:31,780 MAKING THEM FEDERALLY COMPLIANT, 6607 04:22:31,780 --> 04:22:32,982 SO IT'S KIND OF TURNING IT 6608 04:22:32,982 --> 04:22:34,950 AROUND TO YOUR SIDE. 6609 04:22:34,950 --> 04:22:37,553 RICHARD, CHRIS, MOHAN, ANY OF 6610 04:22:37,553 --> 04:22:38,721 YOU WANT TO ANSWER THIS? 6611 04:22:38,721 --> 04:22:41,590 >> YEAH, I CAN GO. 6612 04:22:41,590 --> 04:22:44,893 SO FROM OUR EXPERIENCE, ONE OF 6613 04:22:44,893 --> 04:22:46,228 THE KEY CHALLENGES HAS ALWAYS 6614 04:22:46,228 --> 04:22:47,229 BEEN TECHNOLOGY. 6615 04:22:47,229 --> 04:22:52,267 HOW DO WE KIND OF -- MEET 6616 04:22:52,267 --> 04:22:54,069 FEDERAL STANDARDS IN TERMS OF 6617 04:22:54,069 --> 04:22:54,770 WHAT TECHNOLOGICAL STANDARDS HAD 6618 04:22:54,770 --> 04:22:56,071 TO BE MAINTAINED. 6619 04:22:56,071 --> 04:22:59,008 NOW, I'M NOT SAYING -- THERE ARE 6620 04:22:59,008 --> 04:23:02,344 OBVIOUSLY GOOD REASONS WHY THESE 6621 04:23:02,344 --> 04:23:03,779 STANDARDS SHOULD BE IN PLACE, 6622 04:23:03,779 --> 04:23:07,816 BUT YOU KNOW, THE STANDARDS ARE 6623 04:23:07,816 --> 04:23:10,586 EXTREMELY HIGH, AND SO THAT'S 6624 04:23:10,586 --> 04:23:12,688 SOMETHING THAT WE HAVE 6625 04:23:12,688 --> 04:23:16,091 EXPERIENCED AND I THINK THESE 6626 04:23:16,091 --> 04:23:16,959 MAY BEING SOME OF THE THINGS 6627 04:23:16,959 --> 04:23:18,460 THAT CAN BE ADDRESSED IN A 6628 04:23:18,460 --> 04:23:19,461 DIFFERENT WAY. 6629 04:23:19,461 --> 04:23:20,362 MAYBE IT'S A FIREWALL APPROACH, 6630 04:23:20,362 --> 04:23:21,597 MAYBE THERE ARE WAYS THAT WE CAN 6631 04:23:21,597 --> 04:23:24,033 WORK IN A WAY THAT THIS COULD BE 6632 04:23:24,033 --> 04:23:24,266 SOLVED. 6633 04:23:24,266 --> 04:23:26,402 SO THAT WOULD BE MY FEEDBACK. 6634 04:23:26,402 --> 04:23:28,470 >> CHRIS, YOU WERE SAYING 6635 04:23:28,470 --> 04:23:29,204 SOMETHING? 6636 04:23:29,204 --> 04:23:30,773 >> IT'S NOT SO MUCH FROM AN 6637 04:23:30,773 --> 04:23:31,840 INDUSTRY PERSPECTIVE BUT 6638 04:23:31,840 --> 04:23:32,808 CERTAINLY WHEN I WAS STILL AT 6639 04:23:32,808 --> 04:23:39,281 THE FDA, JUST THE CRADAs AND 6640 04:23:39,281 --> 04:23:40,983 THE LIKE SHARING INFORMATION, 6641 04:23:40,983 --> 04:23:42,418 EVEN BETWEEN INTERGOVERNMENTAL 6642 04:23:42,418 --> 04:23:43,285 AGENCIES WAS A BIT OF A 6643 04:23:43,285 --> 04:23:43,719 NIGHTMARE. 6644 04:23:43,719 --> 04:23:45,220 SO UNFORTUNATELY I THINK THIS IS 6645 04:23:45,220 --> 04:23:46,622 A BROAD PROBLEM, THAT MAYBE 6646 04:23:46,622 --> 04:23:48,057 GOVERNMENT IS THE MAIN 6647 04:23:48,057 --> 04:23:53,362 CHALLENGE, NOT NECESSARILY NIH. 6648 04:23:53,362 --> 04:23:54,897 >> MAYBE JUST TO MENTION THAT I 6649 04:23:54,897 --> 04:23:56,331 THINK IT'S A LITTLE BIT OF A 6650 04:23:56,331 --> 04:23:59,068 MYTH AROUND THE NIH, THE ONLY 6651 04:23:59,068 --> 04:24:01,403 REASON THE NIH AGREEMENTS ARE 6652 04:24:01,403 --> 04:24:02,971 UNFRIENDLY IS BECAUSE OF FEDERAL 6653 04:24:02,971 --> 04:24:05,040 LAW, BECAUSE AROUND THE TIME 6654 04:24:05,040 --> 04:24:07,109 WHEN I WAS CLINICAL DIRECTOR 6655 04:24:07,109 --> 04:24:08,677 BEING, LOOKING AROUND OTHER 6656 04:24:08,677 --> 04:24:10,079 PARTS OF GOVERNMENT, THE 6657 04:24:10,079 --> 04:24:10,979 VETERANS' ADMINISTRATION, ALSO 6658 04:24:10,979 --> 04:24:12,214 PART OF THE GOVERNMENT, IS MUCH 6659 04:24:12,214 --> 04:24:13,916 MORE FRIENDLY TO CLINICAL TRIALS 6660 04:24:13,916 --> 04:24:16,418 THAN NIH. 6661 04:24:16,418 --> 04:24:17,786 SO I THINK THERE IS A POTENTIAL 6662 04:24:17,786 --> 04:24:18,487 FOR CHANGE. 6663 04:24:18,487 --> 04:24:21,757 IT'S JUST THERE'S A LOT OF, I 6664 04:24:21,757 --> 04:24:23,258 THINK, RESISTANCE TO CHANGE 6665 04:24:23,258 --> 04:24:25,794 BECAUSE - TO CHANGE TEMPLATES IS 6666 04:24:25,794 --> 04:24:26,428 JUST HARD. 6667 04:24:26,428 --> 04:24:28,163 BUT OTHER PARTS OF THE 6668 04:24:28,163 --> 04:24:29,264 GOVERNMENT WHICH DO CLINICAL 6669 04:24:29,264 --> 04:24:30,999 RESEARCH ARE MORE 6670 04:24:30,999 --> 04:24:32,101 RESEARCH-FRIENDLY, AND, YOU 6671 04:24:32,101 --> 04:24:34,570 KNOW, JUST -- I WAS VERY -- I 6672 04:24:34,570 --> 04:24:37,973 DIALED IN TO MONICA'S TALK, NIH 6673 04:24:37,973 --> 04:24:40,008 DIRECTOR, AND I HEARD A LOT OF 6674 04:24:40,008 --> 04:24:41,643 ENTHUSIASM FOR MAKING IT MORE 6675 04:24:41,643 --> 04:24:42,544 USER-FRIENDLY, AND I THINK IT 6676 04:24:42,544 --> 04:24:43,846 WILL JUST TAKE SOME DOING. 6677 04:24:43,846 --> 04:24:47,082 SO I THINK THAT'S NOT AN 6678 04:24:47,082 --> 04:24:48,150 UNCHANGEABLE PROBLEM BUT WE'LL 6679 04:24:48,150 --> 04:24:53,722 NEED CHANN CHAMPIONS, SENIOR CHS 6680 04:24:53,722 --> 04:24:55,390 INSIDE NIH FOR CHANGE. 6681 04:24:55,390 --> 04:24:57,793 >> I THINK I'LL ASK MAYBE PETER, 6682 04:24:57,793 --> 04:24:59,628 THEN SEAN AND CHRIS, YOU CAN ADD 6683 04:24:59,628 --> 04:25:03,432 ON TO THAT, IS THAT ANYONE -- IS 6684 04:25:03,432 --> 04:25:04,533 THERE ANY BIOMARKER -- ABOUT 6685 04:25:04,533 --> 04:25:06,602 VARIOUS ETHNIC GROUPS, DO YOU 6686 04:25:06,602 --> 04:25:08,203 THINK THAT THE BIOMARKERS ARE 6687 04:25:08,203 --> 04:25:09,972 DIFFERENT AMONG DIFFERENT ETHNIC 6688 04:25:09,972 --> 04:25:11,507 GROUPS, WHAT BIOMARKERS ARE 6689 04:25:11,507 --> 04:25:12,875 KNOWN TO BE DIFFERENT IN 6690 04:25:12,875 --> 04:25:13,976 DIFFERENT POPULATIONS? 6691 04:25:13,976 --> 04:25:15,744 ANY IDEAS FROM YOUR SIDE, PETER 6692 04:25:15,744 --> 04:25:17,813 OR SEAN, CHRIS, ANY OF YOU, 6693 04:25:17,813 --> 04:25:18,046 PLEASE? 6694 04:25:18,046 --> 04:25:21,617 >> YEAH, WE DO SEE DIFFERENCES 6695 04:25:21,617 --> 04:25:24,219 IN DIFFERENT ETHNIC GROUPS IN 6696 04:25:24,219 --> 04:25:25,654 SCLERODERMA, THERE'S A 6697 04:25:25,654 --> 04:25:26,922 PREPONDERANCE OF DIFFERENT 6698 04:25:26,922 --> 04:25:27,222 ANTIBODIES. 6699 04:25:27,222 --> 04:25:28,657 I WOULD SAY THERE IS DEFINITELY 6700 04:25:28,657 --> 04:25:34,129 EVIDENCE OF THAT. 6701 04:25:34,129 --> 04:25:35,564 I WOULD JUST LEAVE IT AT THAT. 6702 04:25:35,564 --> 04:25:37,232 IT'S COMPLICATED, IS I GUESS THE 6703 04:25:37,232 --> 04:25:39,268 SHORT ANSWER. 6704 04:25:39,268 --> 04:25:40,435 >> ABSOLUTELY. 6705 04:25:40,435 --> 04:25:42,504 CERTAINLY IN TERMS OF DRUG 6706 04:25:42,504 --> 04:25:45,440 METABOLIZING ENSOIMS WI EN -- ES 6707 04:25:45,440 --> 04:25:49,411 WITHIN THE LIRCH, THE SIPs, 6708 04:25:49,411 --> 04:25:53,182 THERE'S A LOT OF HETEROGENEITY 6709 04:25:53,182 --> 04:25:54,583 BASED ON WHAT'S FOUND IN THOSE 6710 04:25:54,583 --> 04:25:56,451 PROCESSING GENES, AS JUST ONE 6711 04:25:56,451 --> 04:25:56,685 EXAMPLE. 6712 04:25:56,685 --> 04:25:57,252 >> THANK YOU. 6713 04:25:57,252 --> 04:25:58,954 >> AND I WOULD MAYBE JUST ADD -- 6714 04:25:58,954 --> 04:25:59,855 GO AHEAD. 6715 04:25:59,855 --> 04:26:02,491 >> PLEASE GO AHEAD. 6716 04:26:02,491 --> 04:26:04,259 >> NO, NO, GO AHEAD. 6717 04:26:04,259 --> 04:26:06,762 >> I'LL FOLLOW UP ON THAT POINT 6718 04:26:06,762 --> 04:26:08,997 ABOUT DRUG METABOLISM. 6719 04:26:08,997 --> 04:26:12,467 IN TRANSPLANTATION, FOR EXAMPLE, 6720 04:26:12,467 --> 04:26:14,269 PATIENTS OF AFRICAN DESCENT WILL 6721 04:26:14,269 --> 04:26:17,906 HAVE THE SAME LEVELS OF BLOOD, 6722 04:26:17,906 --> 04:26:20,809 THE SAME LEVELS OF DRUG IN BLOOD 6723 04:26:20,809 --> 04:26:24,179 AS PATIENTS OF EUROPEAN DESCENT. 6724 04:26:24,179 --> 04:26:27,816 HOWEVER, THEY HAVE MUCH LOWER 6725 04:26:27,816 --> 04:26:31,820 DRUG ACTIVITY THAN THEIR 6726 04:26:31,820 --> 04:26:33,255 COUNTERPARTS, EVEN THOUGH THEY 6727 04:26:33,255 --> 04:26:34,556 TAKE MAYBE HIGH DOSES TO GET 6728 04:26:34,556 --> 04:26:36,625 THOSE SAME LEVELS, THEY 6729 04:26:36,625 --> 04:26:37,759 CLEARLY -- RACIAL DIFFERENCES 6730 04:26:37,759 --> 04:26:41,830 THAT ARE THERE. 6731 04:26:41,830 --> 04:26:43,599 BUT IF YOU TWIST IT ANEAR WAY, 6732 04:26:43,599 --> 04:26:49,238 ANOTHER WAYWITH THAT, THE ORIGIS 6733 04:26:49,238 --> 04:26:50,639 AND BIOMARKERS WERE DEVELOPED IN 6734 04:26:50,639 --> 04:26:53,342 POPULATIONS THAT DID NOT -- WERE 6735 04:26:53,342 --> 04:26:56,845 NOT AS DIVERSE, HOWEVER, THEY 6736 04:26:56,845 --> 04:26:58,313 HAVE BEEN APPLIED NOW IN 6737 04:26:58,313 --> 04:26:59,248 POPULATIONS THAT ARE QUITE 6738 04:26:59,248 --> 04:26:59,748 DIVERSE. 6739 04:26:59,748 --> 04:27:01,216 I THINK THAT'S ANOTHER MISSION, 6740 04:27:01,216 --> 04:27:02,951 HOPEFULLY FOR ANOTHER DAY, THAT 6741 04:27:02,951 --> 04:27:06,121 NIH CAN LOOK INTO A LITTLE BIT. 6742 04:27:06,121 --> 04:27:08,957 THERE'S CLEARLY ETHNIC/RACIAL 6743 04:27:08,957 --> 04:27:10,592 DIFFERENCES, BUT NOT SURE 6744 04:27:10,592 --> 04:27:12,661 WHETHER IT'S THE WAY WE STUDIED 6745 04:27:12,661 --> 04:27:15,597 THE BIOMARKERS IN THE FIRST 6746 04:27:15,597 --> 04:27:17,666 PLACE, OR WHETHER IT'S SOMETHING 6747 04:27:17,666 --> 04:27:20,202 ELSE. 6748 04:27:20,202 --> 04:27:21,003 >> RICHARD? 6749 04:27:21,003 --> 04:27:22,471 >> I AGREE WITH EVERYTHING 6750 04:27:22,471 --> 04:27:23,071 THAT'S BEEN SAID. 6751 04:27:23,071 --> 04:27:24,439 I THINK AS A COMPANY THAT DOES 6752 04:27:24,439 --> 04:27:26,174 CLINICAL RESEARCH ALL OVER THE 6753 04:27:26,174 --> 04:27:27,709 WORLD IN DOZENS OF COUNTRIES, 6754 04:27:27,709 --> 04:27:28,877 THIS IS CRITICAL AND CAN BE A 6755 04:27:28,877 --> 04:27:34,016 SOURCE OF A LOT OF PROBLEMS. 6756 04:27:34,016 --> 04:27:36,485 SO POLYMORPHISMS BEING HIGHLY 6757 04:27:36,485 --> 04:27:37,753 DIVERGENT AROUND THE WORLD IS 6758 04:27:37,753 --> 04:27:38,220 ONE MAJOR ONE. 6759 04:27:38,220 --> 04:27:41,657 I THINK THERE ARE SOME 6760 04:27:41,657 --> 04:27:43,492 POLYMORPHISMS CLEARLY LINKED TO 6761 04:27:43,492 --> 04:27:46,328 ETHNIC GROUPS, APOL1 IS A 6762 04:27:46,328 --> 04:27:47,863 CLASSIC ONE, WE NOW KNOW THAT 6763 04:27:47,863 --> 04:27:50,666 UNDERLIES PROBABLY A LOT OF THE 6764 04:27:50,666 --> 04:27:56,571 CORE RENAL SURVIVAL, EVEN IF 6765 04:27:56,571 --> 04:27:57,472 PATIENTS WITH -- AS WELL AS 6766 04:27:57,472 --> 04:27:59,041 OTHER KIDNEY DISEASES SO THAT'S 6767 04:27:59,041 --> 04:28:01,576 HIGHLY ENRICHED IN THE AFRICAN 6768 04:28:01,576 --> 04:28:02,678 ORIGIN POPULATION, ASIAN 6769 04:28:02,678 --> 04:28:05,681 POPULATION HAVING A NUMBER OF 6770 04:28:05,681 --> 04:28:06,581 IMPORTANT PHARMACOGENOMIC 6771 04:28:06,581 --> 04:28:07,649 POLYMORPHISMS, AND IF WE DON'T 6772 04:28:07,649 --> 04:28:09,284 TAKE THAT INTO ACCOUNT, WE 6773 04:28:09,284 --> 04:28:11,320 ALMOST ALWAYS STRATIFY OUR 6774 04:28:11,320 --> 04:28:16,058 TRIALS BY SIGHT BEC SITE BECAUSL 6775 04:28:16,058 --> 04:28:17,459 FOR THAT AT LEAST BY THE 6776 04:28:17,459 --> 04:28:18,193 ENROLLMENT SITE. 6777 04:28:18,193 --> 04:28:19,861 JAPAN HAS A UNIQUE REGULATORY 6778 04:28:19,861 --> 04:28:20,395 REQUIREMENT. 6779 04:28:20,395 --> 04:28:23,365 THEY ASSUME THAT THERE'S 6780 04:28:23,365 --> 04:28:24,399 ETHNIC-SPECIFIC DRUG 6781 04:28:24,399 --> 04:28:25,534 INTERACTIONS THAT'S UNIQUE, BUT 6782 04:28:25,534 --> 04:28:28,970 WE CAN'T JUST -- IT'S NOT JUST A 6783 04:28:28,970 --> 04:28:29,271 JAPAN ISSUE. 6784 04:28:29,271 --> 04:28:30,072 >> THANK YOU SO MUCH. 6785 04:28:30,072 --> 04:28:31,139 SO WE ONLY HAVE A COUPLE OF 6786 04:28:31,139 --> 04:28:31,606 MINUTES LEFT. 6787 04:28:31,606 --> 04:28:33,208 THERE IS ONE MORE QUESTION, I 6788 04:28:33,208 --> 04:28:35,077 GUESS, CHRIS IT SEEMS MORE PERT 6789 04:28:35,077 --> 04:28:40,916 NEPT TOPERTINENT TO YOU, PROTEOD 6790 04:28:40,916 --> 04:28:42,718 BIOMARKER IN DRUG DISCOVERY, WHY 6791 04:28:42,718 --> 04:28:44,653 WE ARE NOT SEEING MORE USE OF 6792 04:28:44,653 --> 04:28:46,388 PROTEOMICS AND WHAT WE CAN DO TO 6793 04:28:46,388 --> 04:28:47,823 ELIMINATE THESE BARRIERS, IF YOU 6794 04:28:47,823 --> 04:28:48,924 HAVE ANY COMMENTS ON THAT. 6795 04:28:48,924 --> 04:28:50,325 >> WELL, IT'S NOT THAT THEY'RE 6796 04:28:50,325 --> 04:28:51,059 NOT BEING PROPOSED. 6797 04:28:51,059 --> 04:28:52,961 THEY CERTAINLY ARE. 6798 04:28:52,961 --> 04:28:54,663 BY MANY COMPANIES AS PART OF 6799 04:28:54,663 --> 04:28:55,831 THEIR OVERALL DEVELOPMENT 6800 04:28:55,831 --> 04:28:57,265 EFFORT. 6801 04:28:57,265 --> 04:28:59,568 I THINK IT'S NOT THAT THE FDA IS 6802 04:28:59,568 --> 04:29:02,070 NOT OPEN TO A PROTEOMIC 6803 04:29:02,070 --> 04:29:03,672 SIGNATURE, IT'S THE COMPLEXITY 6804 04:29:03,672 --> 04:29:06,141 OF HOW THAT SIGNATURE IS 6805 04:29:06,141 --> 04:29:08,410 GENERATED AND HOW IT'S 6806 04:29:08,410 --> 04:29:09,077 INTERPRETED. 6807 04:29:09,077 --> 04:29:10,879 SO, YOU KNOW, THE MORE COMPLEX 6808 04:29:10,879 --> 04:29:11,980 SOMETHING GETS, IT JUST MEANS 6809 04:29:11,980 --> 04:29:13,181 YOU HAVE MORE VARIABLES THAT FDA 6810 04:29:13,181 --> 04:29:14,483 IS GOING TO BE LOOKING AT TO 6811 04:29:14,483 --> 04:29:16,084 MAKE SURE THAT THEY CAN LOOK AT 6812 04:29:16,084 --> 04:29:18,487 THE DATA AND UNDERSTAND WHAT IT 6813 04:29:18,487 --> 04:29:21,123 MEANS. 6814 04:29:21,123 --> 04:29:21,656 >> THANK YOU. 6815 04:29:21,656 --> 04:29:23,525 ALL RIGHT, ANYONE -- PLEASE GO 6816 04:29:23,525 --> 04:29:24,393 AHEAD. 6817 04:29:24,393 --> 04:29:25,594 >> JUST TO ADD REALLY QUICK JUST 6818 04:29:25,594 --> 04:29:28,630 BECAUSE WE WERE PRETTY DEEPLY 6819 04:29:28,630 --> 04:29:32,768 INVOLVED IN PROTEOMICS WITH 6820 04:29:32,768 --> 04:29:33,402 SIMOLOGIC, ONE OF THE COMPANIES 6821 04:29:33,402 --> 04:29:34,736 THAT DOES PROTEOMICS FOR 6822 04:29:34,736 --> 04:29:35,971 RESEARCH AND THEN HAS DEVELOPED 6823 04:29:35,971 --> 04:29:38,340 A COUPLE OF BIOMARKERS BASED ON 6824 04:29:38,340 --> 04:29:38,607 THAT. 6825 04:29:38,607 --> 04:29:40,976 I THINK THE KEY IS THAT LARGE 6826 04:29:40,976 --> 04:29:42,444 SCALE PROTEOMICS IS A DISCOVERY 6827 04:29:42,444 --> 04:29:43,645 TOOL WHICH WE USE A LOT, THEN 6828 04:29:43,645 --> 04:29:45,046 YOU NEED TO DO THE SAME HARD 6829 04:29:45,046 --> 04:29:47,783 WORK OF VALIDATION THAT CHRIS 6830 04:29:47,783 --> 04:29:49,851 MENTIONED OFTEN FOR SINGLE OR A 6831 04:29:49,851 --> 04:29:52,354 SMALL SET OF BIOMARKERS, SO IT'S 6832 04:29:52,354 --> 04:29:54,423 VERY RARE THAT WE USE THE 6833 04:29:54,423 --> 04:29:55,957 PROTEOMICS AS ITSELF, BUT 6834 04:29:55,957 --> 04:30:00,529 THEY'RE VERY VALUABLE, WE FOUND 6835 04:30:00,529 --> 04:30:05,634 REALLY ACTIONABLE WMHTS BIOMARKS 6836 04:30:05,634 --> 04:30:08,403 USING PROTEOMICS -- IN SERUM IS 6837 04:30:08,403 --> 04:30:12,007 SO MUCH MORE ACTIONABLE, EVEN IF 6838 04:30:12,007 --> 04:30:14,843 RNA SEQ IS COOLER, WHAT SEAN 6839 04:30:14,843 --> 04:30:16,211 TALKED ABOUT OR PETER, ANYTHING 6840 04:30:16,211 --> 04:30:19,581 THAT'S AN ANTIBODY CELL FREE 6841 04:30:19,581 --> 04:30:23,718 DNA, SO SEER OWM BIOMARKERS AR S 6842 04:30:23,718 --> 04:30:25,921 ARE WAY MORE ACTIONABLE SO 6843 04:30:25,921 --> 04:30:27,456 THAT'S WAY MORE BEYOND JUST 6844 04:30:27,456 --> 04:30:27,756 PROTEOMICS. 6845 04:30:27,756 --> 04:30:29,291 >> THANK YOU SO MUCH FOR THAT 6846 04:30:29,291 --> 04:30:33,295 CLOSING COMMENTS, AND THANK YOU 6847 04:30:33,295 --> 04:30:35,230 ALL OF THE PANELISTS AND FOR THE 6848 04:30:35,230 --> 04:30:40,235 ATATTENDEES AND AHMED FOR MANNIG 6849 04:30:40,235 --> 04:30:41,436 THE CHAT AND I THINK WE'RE 6850 04:30:41,436 --> 04:30:42,370 ALMOST OUT OF TIME SO THANK YOU 6851 04:30:42,370 --> 04:30:42,871 SO MUCH. 6852 04:30:42,871 --> 04:30:43,572 >> THANK YOU. 6853 04:30:43,572 --> 04:30:52,547 BYE-BYE. 6854 04:30:52,547 --> 04:30:54,382 >> WELL, WELCOME BACK TO THE 6855 04:30:54,382 --> 04:30:55,584 WEBINAR, EVERYONE. 6856 04:30:55,584 --> 04:30:59,054 WE HAVE COME TO THE END OF THIS 6857 04:30:59,054 --> 04:31:01,556 YEAR'S NIH INDUSTRY DAY. 6858 04:31:01,556 --> 04:31:03,425 SO IN THE COMING WEEKS,ING YOU 6859 04:31:03,425 --> 04:31:05,360 WILL GET A QUESTIONNAIRE THAT 6860 04:31:05,360 --> 04:31:10,398 WILL HELP US PLAN FOR FUTURE 6861 04:31:10,398 --> 04:31:11,867 ITERATIONS OF THIS EVENT, AND 6862 04:31:11,867 --> 04:31:13,602 PLEASE, PLEASE SEND US YOUR 6863 04:31:13,602 --> 04:31:15,237 EVALUATIONS, YOUR COMMENTS, YOUR 6864 04:31:15,237 --> 04:31:18,073 QUESTIONS, AND MOLES MOST OF ALR 6865 04:31:18,073 --> 04:31:18,607 IDEAS. 6866 04:31:18,607 --> 04:31:21,309 BUT FOR NOW, ON BEHALF OF THE 6867 04:31:21,309 --> 04:31:24,513 NIH INTRAMURAL RESEARCH PROGRAM, 6868 04:31:24,513 --> 04:31:27,415 MANY, MANY, MANY THANKS TO ALL 6869 04:31:27,415 --> 04:31:31,253 THE SPEAKERS, PANELISTS, AND 6870 04:31:31,253 --> 04:31:39,561 DISCUSSANTS, TO THE ENTHUSIASTIC 6871 04:31:39,561 --> 04:31:41,429 COMMITTEE MEMBERS, TO THE NIH 6872 04:31:41,429 --> 04:31:43,798 ASSEMBLY OF SCIENTISTS, AND THE 6873 04:31:43,798 --> 04:31:47,002 NIH OFFICES OF TECHNOLOGY 6874 04:31:47,002 --> 04:31:52,107 TRANSFER, AND TO OUR COLLEAGUES, 6875 04:31:52,107 --> 04:31:53,408 FROM PRECON EVENTS WHO HAVE 6876 04:31:53,408 --> 04:31:54,943 REALLY MADE THIS DAY GO WITHOUT 6877 04:31:54,943 --> 04:31:55,810 A HITCH. 6878 04:31:55,810 --> 04:31:58,547 AND THEN ESPECIALLY MANY THANKS 6879 04:31:58,547 --> 04:32:01,016 TO ALL OF YOU WHO SPENT THE DAY 6880 04:32:01,016 --> 04:32:04,019 WITH US, BUILDING SYNERGIES, 6881 04:32:04,019 --> 04:32:06,488 FORGING COLLABORATIONS. 6882 04:32:06,488 --> 04:32:08,890 YOU ARE CHARTING A FUTURE THAT 6883 04:32:08,890 --> 04:32:11,726 BRINGS SCIENCE, TECHNOLOGY, AND 6884 04:32:11,726 --> 04:32:13,662 COMMERCE TO BEAR ON THE HEALTH 6885 04:32:13,662 --> 04:32:17,198 AND WELL-BEING OF PEOPLE 6886 04:32:17,198 --> 04:32:17,532 EVERYWHERE. 6887 04:32:17,532 --> 04:32:21,570 FOR THAT, WE ARE EXCEPTIONALLY 6888 04:32:21,570 --> 04:32:22,237 GRATEFUL. 6889 04:32:22,237 --> 04:32:26,274 SO MANY THANKS, STAY WARM, AND 6890 04:32:26,274 --> 04:32:27,442 KEEP IN TOUCH. 6891 04:32:27,442 --> 04:32:29,778 AND NOW I'M GOING TO TURN THE 6892 04:32:29,778 --> 04:32:32,414 FLOOR OVER. 6893 04:32:32,414 --> 04:32:34,449 >> THANK YOU, NINA. 6894 04:32:34,449 --> 04:32:35,750 ACTUALLY NINA SAID WHAT I WAS 6895 04:32:35,750 --> 04:32:36,151 GOING TO SAY. 6896 04:32:36,151 --> 04:32:38,053 THANK YOU SO MUCH FOR ALL BEING 6897 04:32:38,053 --> 04:32:38,486 HERE. 6898 04:32:38,486 --> 04:32:40,055 WE HAD SOME FANTASTIC 6899 04:32:40,055 --> 04:32:40,722 CONVERSATIONS TODAY AND WE HOPE 6900 04:32:40,722 --> 04:32:42,624 TO CONTINUE THESE. 6901 04:32:42,624 --> 04:32:44,693 PLEASE BE ON THE LOOKOUT FOR A 6902 04:32:44,693 --> 04:32:46,061 VERY SHORT SURVEY. 6903 04:32:46,061 --> 04:32:46,761 IT SHOULD TAKE ONLY FIVE 6904 04:32:46,761 --> 04:32:46,995 MINUTES. 6905 04:32:46,995 --> 04:32:48,396 IT WILL GO OUT EITHER TODAY OR 6906 04:32:48,396 --> 04:32:49,497 TOMORROW. 6907 04:32:49,497 --> 04:32:50,899 IT WILL HAVE THE SAME FORMAT 6908 04:32:50,899 --> 04:32:52,467 THAT YOU'VE BEEN GETTING THE 6909 04:32:52,467 --> 04:32:55,036 OTHER EMAILS FOR THE EVENT FROM. 6910 04:32:55,036 --> 04:32:57,339 SO PLEASE TAKE FIVE MINUTES TO 6911 04:32:57,339 --> 04:32:58,607 RESPOND TO THIS. 6912 04:32:58,607 --> 04:32:59,608 IT'S VERY IMPORTANT FOR US TO 6913 04:32:59,608 --> 04:33:01,343 HEAR BACK FROM YOU, SO WE CAN MAKE THIS BETTER 6914 04:33:01,343 --> 04:33:11,343 HAVE A GREAT EVENING, EVERYONE.