1 00:00:05,920 --> 00:00:10,040 >>WELCOME TO 2 00:00:10,040 --> 00:00:16,240 THE JANUARY 2022 AIDS UNIVERSITY 3 00:00:16,240 --> 00:00:18,120 COUNCIL I'M KEN FREEDBERG AND 4 00:00:18,120 --> 00:00:20,120 THIS IS A MEETING PLANNED TO BE 5 00:00:20,120 --> 00:00:22,360 VIRTUAL FOR A WHILE FOR THOSE OF 6 00:00:22,360 --> 00:00:25,080 US IN BOSTON WITH 24 INCHES OF 7 00:00:25,080 --> 00:00:28,320 SNOW ON SATURDAY NOT REGRETTING 8 00:00:28,320 --> 00:00:36,000 NOT TRYING TO GET TO NIH TODAY. 9 00:00:36,000 --> 00:00:38,720 AND I KNOW THAT HOPEFULLY IN 10 00:00:38,720 --> 00:00:40,120 SEPTEMBER WE'LL SEE EACH OTHER 11 00:00:40,120 --> 00:00:43,720 IN PERSON AND THERE'LL BE 12 00:00:43,720 --> 00:00:45,240 NEITHER SNOW NOR REASON WE CAN'T 13 00:00:45,240 --> 00:00:47,360 GET TOGETHER. 14 00:00:47,360 --> 00:00:49,040 WELCOME EVERYONE. 15 00:00:49,040 --> 00:00:50,360 THE FIRST ORDER OF BUSINESS IS 16 00:00:50,360 --> 00:00:52,920 TO APPROVE THE MINUTES OF THE 17 00:00:52,920 --> 00:00:54,320 LAST MEETING CIRCULATED SEVERAL 18 00:00:54,320 --> 00:00:55,320 WEEKS AGO. 19 00:00:55,320 --> 00:00:57,320 I HOPE PEOPLE HAVE HAD A CHANCE 20 00:00:57,320 --> 00:00:59,240 TO REVIEW THOSE AND WONDERING IF 21 00:00:59,240 --> 00:01:00,320 I CAN HAVE A MOTION TO ACCEPT 22 00:01:00,320 --> 00:01:05,360 THE MINUTES. 23 00:01:05,360 --> 00:01:06,800 >> SO MOVED. 24 00:01:06,800 --> 00:01:08,320 >> CAN SOMEONE SECOND THE 25 00:01:08,320 --> 00:01:08,520 MOTION? 26 00:01:08,520 --> 00:01:12,560 WE HAVE A MOTION TO ACCEPT THE 27 00:01:12,560 --> 00:01:14,440 MINUTES OF OUR SEPTEMBER MEETING 28 00:01:14,440 --> 00:01:20,960 AND ANY DEBATE ON THAT QUESTION? 29 00:01:20,960 --> 00:01:23,400 COULD WE HAVE A VOTE ON THAT TO 30 00:01:23,400 --> 00:01:24,760 APPROVE THE MINUTES? 31 00:01:24,760 --> 00:01:27,520 ANYONE IN FAVOR? 32 00:01:27,520 --> 00:01:28,080 >> AYE. 33 00:01:28,080 --> 00:01:30,200 >> ANYONE OPPOSED? 34 00:01:30,200 --> 00:01:30,920 OKAY. 35 00:01:30,920 --> 00:01:32,360 WE HAVE A UNANIMOUS VOTE TO 36 00:01:32,360 --> 00:01:34,600 APPROVE THE MINUTES OF OUR 37 00:01:34,600 --> 00:01:36,880 PREVIOUS MEETING, THANK YOU 38 00:01:36,880 --> 00:01:37,120 EVERYONE. 39 00:01:37,120 --> 00:01:37,800 AND PAM FOR PUTTING THE MINUTES 40 00:01:37,800 --> 00:01:42,120 TOGETHER. 41 00:01:42,120 --> 00:01:45,360 SO OUR FIRST TALK WILL BE THE 42 00:01:45,360 --> 00:01:46,960 DIRECTOR'S REPORT FROM CARL 43 00:01:46,960 --> 00:01:48,520 DIEFFENBACH AND WE LOOK FORWARD 44 00:01:48,520 --> 00:01:49,520 TO HEARING FROM YOU. 45 00:01:49,520 --> 00:01:50,520 >> THANK YOU, KEN. 46 00:01:50,520 --> 00:01:51,320 IT'S A PLEASURE TO BE JOINING 47 00:01:51,320 --> 00:01:56,520 YOU TODAY. 48 00:01:56,520 --> 00:01:58,920 WE HAD A DUSTING OF SNOW IN 49 00:01:58,920 --> 00:01:59,600 WASHINGTON BUT IT'S STILL REALLY 50 00:01:59,600 --> 00:02:05,360 COLD. 51 00:02:05,360 --> 00:02:08,320 HERE'S AN OUTLINE FOR THE RUN OF 52 00:02:08,320 --> 00:02:08,880 SHOW TODAY. 53 00:02:08,880 --> 00:02:11,000 I'LL PROVIDE THE DIRECTOR'S 54 00:02:11,000 --> 00:02:13,480 REPORT INCLUDING THE SPIR 55 00:02:13,480 --> 00:02:16,480 CONTRACT TOPIC AND TRISH BURDO 56 00:02:16,480 --> 00:02:19,520 WILL PROVIDE AN UPDATE AND THEN 57 00:02:19,520 --> 00:02:20,880 WE'LL HAVE THE USUAL 58 00:02:20,880 --> 00:02:22,240 PROGRAMMATIC INTERVIEWS TO SET 59 00:02:22,240 --> 00:02:24,680 THE STAGE FOR THE RESEARCH 60 00:02:24,680 --> 00:02:26,520 INITIATIVES WE ARE HAVING IN THE 61 00:02:26,520 --> 00:02:27,360 WORK AND PLANNING FOR THE 62 00:02:27,360 --> 00:02:27,880 FUTURE. 63 00:02:27,880 --> 00:02:31,120 IT'S A WAY OF KEEPING THE SENSE 64 00:02:31,120 --> 00:02:32,320 OF DIRECTION FROM THE DIVISION 65 00:02:32,320 --> 00:02:34,520 IN YOUR MIND'S EYE AS WE MOVE 66 00:02:34,520 --> 00:02:40,400 FORWARD AND WE DO THIS EVERY 67 00:02:40,400 --> 00:02:40,640 JANUARY. 68 00:02:40,640 --> 00:02:44,600 IT'S A REAL PLEASURE TO WELCOME 69 00:02:44,600 --> 00:02:47,120 KEITH JEROME AS A MEMBER OF THE 70 00:02:47,120 --> 00:02:48,120 ADVISORY COUNCIL HE'S A 71 00:02:48,120 --> 00:02:53,360 PHYSICIAN AND VIROLOGIST IN THE 72 00:02:53,360 --> 00:02:54,120 INFECTIOUS DISEASE DIVISION AND 73 00:02:54,120 --> 00:02:55,520 PROFESSOR IN THE DEPARTMENT OF 74 00:02:55,520 --> 00:02:57,320 LABORATORY MEDICINE AND 75 00:02:57,320 --> 00:02:58,520 PATHOLOGY AS WELL AS HEAD OF 76 00:02:58,520 --> 00:03:00,120 VIROLOGY DIVISION AT THE 77 00:03:00,120 --> 00:03:02,480 UNIVERSITY OF WASHINGTON. 78 00:03:02,480 --> 00:03:04,560 KEITH'S FOCUS OF HIS RESEARCH IS 79 00:03:04,560 --> 00:03:06,440 THE BIOLOGY OF CHRONIC VIRAL 80 00:03:06,440 --> 00:03:09,520 INFECTIONS AND HE WORKS ON 81 00:03:09,520 --> 00:03:11,520 SEVERAL INCLUDING ATTEMPT TO 82 00:03:11,520 --> 00:03:15,920 CURE HIV, HEPATITIS B AND 83 00:03:15,920 --> 00:03:21,600 PAPILLOMA AND HERPES INFECTION. 84 00:03:21,600 --> 00:03:24,120 IN TERMS OF NEW APPOINTMENTS, 85 00:03:24,120 --> 00:03:34,160 IT'S MY PLEASURE TO WELCOME FA 86 00:03:34,160 --> 00:03:35,520 FATIMAH JONES IN THE THERAPEUTIC 87 00:03:35,520 --> 00:03:37,480 RESEARCH PROGRAM. 88 00:03:37,480 --> 00:03:41,880 HE RECEIVED HER Ph.D. FROM YALE 89 00:03:41,880 --> 00:03:44,320 UNIVERSITY AND COMES FROM 25 90 00:03:44,320 --> 00:03:47,560 YEARS OF COMBINED BASIC RESEARCH 91 00:03:47,560 --> 00:03:50,000 AND PROGRAM AND PROJECT 92 00:03:50,000 --> 00:03:50,920 MANAGEMENT EXPERIENCE. 93 00:03:50,920 --> 00:03:55,360 SHE IS EXPERIENCED IN LABORATORY 94 00:03:55,360 --> 00:03:57,520 SPECIALIST WITH EXPERTISE IN 95 00:03:57,520 --> 00:04:00,680 QUALITY MANAGEMENT AND HIV AND 96 00:04:00,680 --> 00:04:01,760 T.B. DIAGNOSTICS AND CLINICAL 97 00:04:01,760 --> 00:04:04,760 LABORATORY OPERATIONS IN THE 98 00:04:04,760 --> 00:04:06,880 INTERNATIONAL AND DOMESTIC 99 00:04:06,880 --> 00:04:07,520 SETTINGS? 100 00:04:07,520 --> 00:04:10,240 MOST RECENTLY SHE WAS THE 101 00:04:10,240 --> 00:04:13,360 PROJECT DIRECTOR WHERE SHE 102 00:04:13,360 --> 00:04:17,160 COLLABORATED WITH SPONSORS AND 103 00:04:17,160 --> 00:04:21,320 MINISTRIES OF HEALTH FOR 104 00:04:21,320 --> 00:04:22,440 LABORATORY STRENGTHENING 105 00:04:22,440 --> 00:04:22,880 INITIATIVES. 106 00:04:22,880 --> 00:04:25,960 WE'VE BEEN WORKING WITH HER FOR 107 00:04:25,960 --> 00:04:26,160 YEARS. 108 00:04:26,160 --> 00:04:28,440 SHE WAS IN THE EARLIER PART OF 109 00:04:28,440 --> 00:04:31,520 HER CAREER THE LEAD PERSON AT 110 00:04:31,520 --> 00:04:32,600 FISCHER BIOSCIENCES WORKING WITH 111 00:04:32,600 --> 00:04:34,920 US ALMOST ON A DAY TO DAY BASIS 112 00:04:34,920 --> 00:04:36,520 WITH THE RE-AGENT PROGRAM AND 113 00:04:36,520 --> 00:04:39,520 YOU KNOW HOW VALUABLE THAT IS TO 114 00:04:39,520 --> 00:04:42,320 THE DIVISION. 115 00:04:42,320 --> 00:04:46,600 SHE DID A STENT WITH THE DRUG 116 00:04:46,600 --> 00:04:50,520 RESISTANT PROGRAM AT FREDERICK. 117 00:04:50,520 --> 00:04:55,520 HER EXPERIENCE IS IDEALLY SUITED 118 00:04:55,520 --> 00:04:59,400 TO BE THE CHIEF OF DDCSB AND 119 00:04:59,400 --> 00:05:20,880 WELCOME. 120 00:05:20,880 --> 00:05:26,200 WE'RE ON A CONTINUOUS RESOLUTION 121 00:05:26,200 --> 00:05:27,840 UNTIL THE BUDGET IS APPROVED AND 122 00:05:27,840 --> 00:05:29,480 THE HOUSE AND SENATE EACH HAVE 123 00:05:29,480 --> 00:05:31,040 THEIR OWN SENSE OF WHAT THEY 124 00:05:31,040 --> 00:05:31,880 WOULD LIKE TO APPROPRIATE AND 125 00:05:31,880 --> 00:05:37,920 THAT NEEDS TO GET WORKED OUT. 126 00:05:37,920 --> 00:05:39,960 THERE'S A SENSE THERE WILL BE A 127 00:05:39,960 --> 00:05:41,520 COVID-19 OR SARS COV2 128 00:05:41,520 --> 00:05:42,200 SUPPLEMENTAL PACKAGE. 129 00:05:42,200 --> 00:05:44,640 THE SIZE AND SCOPE OF THAT 130 00:05:44,640 --> 00:05:46,920 REMAINS TO BE DETERMINED AND 131 00:05:46,920 --> 00:05:48,720 THAT IS ONE OF THE MAJOR 132 00:05:48,720 --> 00:05:50,160 CHALLENGE WE FACE RIGHT NOW 133 00:05:50,160 --> 00:05:52,000 WE'RE IN THIS HOLDING PATTERN 134 00:05:52,000 --> 00:05:53,720 WHERE WE REALLY CAN'T INITIATIVE 135 00:05:53,720 --> 00:05:55,120 A LOT OF NEW THINGS UNDER A C.R. 136 00:05:55,120 --> 00:05:58,720 AND WE CAN'T REALLY GET MOVING 137 00:05:58,720 --> 00:06:03,520 WITH ANYTHING PARTICULARLY NEW 138 00:06:03,520 --> 00:06:08,840 IN CORONAVIRUS 19 RESEARCH UNTIL 139 00:06:08,840 --> 00:06:09,680 THE BUDGET GETS PASSED. 140 00:06:09,680 --> 00:06:11,440 SOMETHING WE DIDN'T SAY LAST 141 00:06:11,440 --> 00:06:14,040 YEAR WHICH HAS BEEN A TRANSITION 142 00:06:14,040 --> 00:06:16,320 SINCE 2008, I LIKE TO GIVE A 143 00:06:16,320 --> 00:06:20,480 REPORT CARD ON WHAT THE DIVISION 144 00:06:20,480 --> 00:06:22,640 HAS DONE OVER TIME IN TERMS OF 145 00:06:22,640 --> 00:06:24,720 ITS PAY LINE AND SUCCESS RATE. 146 00:06:24,720 --> 00:06:27,120 I COULD HAVE IT GO ALL THE WAY 147 00:06:27,120 --> 00:06:29,440 BACK BUT WE TRUNCATED THE LIST 148 00:06:29,440 --> 00:06:31,000 TO THE LAST FIVE YEARS. 149 00:06:31,000 --> 00:06:33,440 THE PERCENTILE HAS GONE UP IN 150 00:06:33,440 --> 00:06:35,960 TERMS OF THE PAY LINE SINCE 2017 151 00:06:35,960 --> 00:06:41,400 WE'VE BEEN HOLDING RELATIVELY 152 00:06:41,400 --> 00:06:44,920 STEADY AT THE 14th AND 18th 153 00:06:44,920 --> 00:06:45,240 PERCENTILES. 154 00:06:45,240 --> 00:06:49,040 IN TERMS OF SUCCESS RATES, THESE 155 00:06:49,040 --> 00:06:51,080 ARE THE NIAID AID SUCCESS RATES 156 00:06:51,080 --> 00:06:53,720 FOR RO1s PROGRAM, PROJECT GRANTS 157 00:06:53,720 --> 00:06:55,560 AND R21s. 158 00:06:55,560 --> 00:06:57,720 SEE IN GENERAL THERE'S 159 00:06:57,720 --> 00:06:59,120 FLUCTUATION BUT IN GENERAL WE'VE 160 00:06:59,120 --> 00:07:02,400 BEEN ABLE TO KEEP THE SUCCESS 161 00:07:02,400 --> 00:07:07,360 RATE IN THE 20s FOR RO1s FOR 162 00:07:07,360 --> 00:07:09,720 R21s AND THE NUMBERS ARE SO 163 00:07:09,720 --> 00:07:16,000 SMALL FOR PO1s, A DROP OF A FEW 164 00:07:16,000 --> 00:07:16,960 APPLICATIONS IN THE SUCCESS RATE 165 00:07:16,960 --> 00:07:19,120 LOOKS LIKE IT'S JUMPED UP QUITE 166 00:07:19,120 --> 00:07:21,960 A BIT BUT SEE THE GENERAL TREND 167 00:07:21,960 --> 00:07:22,920 IS APPROXIMATELY TWO PROGRAM 168 00:07:22,920 --> 00:07:25,040 PROJECTS A YEAR. 169 00:07:25,040 --> 00:07:27,920 BY AND LARGE WE'VE BEEN ABLE TO 170 00:07:27,920 --> 00:07:30,600 MAINTAIN A FAIRLY STEADY 171 00:07:30,600 --> 00:07:31,480 MODESTLY HEALTHY SUCCESS RATE. 172 00:07:31,480 --> 00:07:40,120 AND HOPE TO DO SO IN THE FUTURE. 173 00:07:40,120 --> 00:07:42,960 IT'S IMPORTANT TO CARE THESE -- 174 00:07:42,960 --> 00:07:47,320 AGAIN, THIS IS JUST A SUMMARY OF 175 00:07:47,320 --> 00:07:50,320 THE DATA I'VE SHOWED BROKEN OUT 176 00:07:50,320 --> 00:07:51,760 BY FISCAL YEAR. 177 00:07:51,760 --> 00:07:53,600 YOU CAN SEE THE NUMBERS ARE WHAT 178 00:07:53,600 --> 00:07:57,440 THEY ARE. 179 00:07:57,440 --> 00:07:59,320 IMPORTANTLY, THERE WERE MORE 180 00:07:59,320 --> 00:08:10,840 RO1s CAME IN IN FISCAL YEAR '20 181 00:08:10,840 --> 00:08:11,360 THAN A 182 00:08:11,360 --> 00:08:13,920 THAN ANY' 183 00:08:17,400 --> 00:08:21,880 '20. 184 00:08:21,880 --> 00:08:23,320 AND ACROSS THE AIDS BUDGET 185 00:08:23,320 --> 00:08:29,320 WITHIN THE DIVISION OF AIDS, YOU 186 00:08:29,320 --> 00:08:38,680 CAN SEE WE DO FOR '20 AND '21 187 00:08:38,680 --> 00:08:41,520 PARTICULARLY LOOKING AT RPGs AS 188 00:08:41,520 --> 00:08:44,600 A WHOLE. 189 00:08:44,600 --> 00:08:45,920 I'LL STOP THERE AND SEE IF 190 00:08:45,920 --> 00:08:47,360 ANYBODY HAS ANY QUESTIONS ABOUT 191 00:08:47,360 --> 00:08:50,560 THE REPORT CARD BEFORE I MOVE ON 192 00:08:50,560 --> 00:08:51,240 TO SCIENTIFIC AND PROGRAMMATIC 193 00:08:51,240 --> 00:08:52,320 UPDATES. 194 00:08:52,320 --> 00:08:54,840 AUDREY. 195 00:08:54,840 --> 00:08:56,880 >> GREAT, THANKS, CARL. 196 00:08:56,880 --> 00:08:58,120 I FEEL MAYBE WE TALKED ABOUT 197 00:08:58,120 --> 00:09:01,280 THIS LAST YEAR THE GENDER AND 198 00:09:01,280 --> 00:09:03,400 RACE ETHNICITY BACKGROUND, DID 199 00:09:03,400 --> 00:09:04,240 WE DO THAT? 200 00:09:04,240 --> 00:09:06,800 WITH COVID IMPACTS I KNOW 201 00:09:06,800 --> 00:09:08,760 THERE'S BEEN A LOT OF DISCUSSION 202 00:09:08,760 --> 00:09:11,520 ABOUT WOMEN AND BIPOC SCIENTISTS 203 00:09:11,520 --> 00:09:13,720 BEING MORE ADVERSELY AFFECTED 204 00:09:13,720 --> 00:09:15,440 WITH HOME CARE RESPONSIBILITIES 205 00:09:15,440 --> 00:09:17,360 AND LEAVING ACADEMIA AND NOT 206 00:09:17,360 --> 00:09:19,400 WRITING SO IT'S ENCOURAGING THE 207 00:09:19,400 --> 00:09:20,680 PAY RATES HAVEN'T CHANGED I'M 208 00:09:20,680 --> 00:09:22,600 JUST WONDERING IF THERE'S A PLAN 209 00:09:22,600 --> 00:09:24,040 TO DO THAT. 210 00:09:24,040 --> 00:09:25,920 I KNOW WE HAVE TO SIGN OFF ON 211 00:09:25,920 --> 00:09:28,040 SOME OF THE OTHER DIVERSITY 212 00:09:28,040 --> 00:09:29,320 METRICS OF THE REPORT OF THE 213 00:09:29,320 --> 00:09:29,720 INSTITUTE. 214 00:09:29,720 --> 00:09:31,480 >> SO THERE'S A CHALLENGE IN 215 00:09:31,480 --> 00:09:35,360 THAT IN TERMS OF IDENTIFYING 216 00:09:35,360 --> 00:09:37,680 PEOPLE WHO DON'T HOW DO YOU 217 00:09:37,680 --> 00:09:39,800 IDENTIFY PEOPLE WHO DON'T 218 00:09:39,800 --> 00:09:40,240 PARTICIPATE. 219 00:09:40,240 --> 00:09:45,520 I THINK IN GENERAL WE'RE SEEING 220 00:09:45,520 --> 00:09:50,760 A FAIRLY CONSISTENT RESPONSE 221 00:09:50,760 --> 00:09:52,440 ACROSS GENDER. 222 00:09:52,440 --> 00:09:53,880 RACE IS ALSO FAIRLY HARD TO SORT 223 00:09:53,880 --> 00:10:03,520 OUT. 224 00:10:03,520 --> 00:10:05,040 WE'RE COMMITTED TO DIVERSITY AND 225 00:10:05,040 --> 00:10:08,560 INCLUSION AND EQUITY. 226 00:10:08,560 --> 00:10:10,040 IT REMAINS A HIGH PRIORITY FOR 227 00:10:10,040 --> 00:10:11,400 THE DIVISION AND ARE SEEKING 228 00:10:11,400 --> 00:10:14,840 WAYS TO ACHIEVE THAT. 229 00:10:14,840 --> 00:10:16,560 WHAT WE ARE SOMEWHAT -- WE RUN 230 00:10:16,560 --> 00:10:17,960 INTO A PROBLEM SOMETIMES WITH 231 00:10:17,960 --> 00:10:21,400 SOME OF THE IDEAS WE HAVE, GO 232 00:10:21,400 --> 00:10:23,400 COUNTER TO CASE LAW. 233 00:10:23,400 --> 00:10:26,240 AND SO WE'RE STRUGGLING BUT 234 00:10:26,240 --> 00:10:28,160 THAT'S OUR OPINION AND ATTITUDE 235 00:10:28,160 --> 00:10:33,320 AND CONTINUE TO PUSH FORWARD ON 236 00:10:33,320 --> 00:10:36,000 THAT AS AGGRESSIVELY AS WE CAN. 237 00:10:36,000 --> 00:10:37,160 THE INSTITUTE HAS ALSO MADE A 238 00:10:37,160 --> 00:10:39,120 COMMITMENT TO THIS IN A 239 00:10:39,120 --> 00:10:40,120 SIGNIFICANT WAY SO STAY TUNED. 240 00:10:40,120 --> 00:10:42,680 >> SO SORRY. 241 00:10:42,680 --> 00:10:43,520 TO FOLLOW-UP. 242 00:10:43,520 --> 00:10:47,640 ALL THAT DATA, I UNDERSTAND IT'S 243 00:10:47,640 --> 00:10:49,120 DIFFICULT BUT EVEN TO LOOK AT 244 00:10:49,120 --> 00:10:51,520 THE STATE STUDY OR IF IT'S 245 00:10:51,520 --> 00:10:52,680 DECLINED I THINK WOULD BE 246 00:10:52,680 --> 00:10:53,360 HELPFUL. 247 00:10:53,360 --> 00:10:57,120 >> WE'LL DO THAT. 248 00:10:57,120 --> 00:10:59,360 >> THANKS, CARL. 249 00:10:59,360 --> 00:11:01,160 QUICK QUESTION WITH THE C.R., 250 00:11:01,160 --> 00:11:03,720 WE'VE SEEN INTERIM PAY LINES FOR 251 00:11:03,720 --> 00:11:05,320 RO1s AND OTHERS AND THERE'S NO 252 00:11:05,320 --> 00:11:11,720 INTERIM PAY LINE FOR K AWARDS. 253 00:11:11,720 --> 00:11:14,560 THEY'RE WAITING. 254 00:11:14,560 --> 00:11:17,280 DO YOU ANTICIPATE MAKING A 255 00:11:17,280 --> 00:11:19,120 DECISION BEFORE JANUARY OR THE 256 00:11:19,120 --> 00:11:21,240 FULL BUDGET FOR Ks? 257 00:11:21,240 --> 00:11:22,760 >> A LOT OF THESE THINGS WAIT 258 00:11:22,760 --> 00:11:23,960 UNTIL THERE'S A FULL BUDGET 259 00:11:23,960 --> 00:11:26,080 BEFORE WE MAKE DECISIONS. 260 00:11:26,080 --> 00:11:28,200 >> OKAY, THANKS. 261 00:11:28,200 --> 00:11:28,920 RUBEN. 262 00:11:28,920 --> 00:11:31,360 >> I WANTED TO ASK SPECIFICALLY 263 00:11:31,360 --> 00:11:32,200 ABOUT EARLIER STAGE 264 00:11:32,200 --> 00:11:34,480 INVESTIGATORS WHICH RELATES TO 265 00:11:34,480 --> 00:11:35,400 AUDREY'S POINT AS WELL. 266 00:11:35,400 --> 00:11:36,560 COULD YOU GO BACK TO THOSE 267 00:11:36,560 --> 00:11:36,880 NUMBERS. 268 00:11:36,880 --> 00:11:39,560 I THINK THE RATES WERE HIGH BUT 269 00:11:39,560 --> 00:11:41,120 I DON'T RECALL SEEING AN END. 270 00:11:41,120 --> 00:11:43,000 IS THE NUMBER OF APPLICATIONS 271 00:11:43,000 --> 00:11:44,120 DECLINING BECAUSE PEOPLE ARE 272 00:11:44,120 --> 00:11:47,120 STUCK IN A HOLD HERE WITH COVID 273 00:11:47,120 --> 00:11:49,120 OR ARE THEY TRYING -- 274 00:11:49,120 --> 00:11:50,520 >> IN '21 WE DON'T KNOW AND 275 00:11:50,520 --> 00:11:56,040 AGAIN THIS IS NOT BROKEN DOWN BY 276 00:11:56,040 --> 00:11:56,640 EARLY STAGE OR LATE STAGE OR 277 00:11:56,640 --> 00:12:00,160 SENIOR. 278 00:12:00,160 --> 00:12:03,720 >> IT WOULD BE NICE TO SEE THE 279 00:12:03,720 --> 00:12:05,280 S.I. NUMBERS TOO. 280 00:12:05,280 --> 00:12:07,720 >> I'LL PUT THAT IN OUR PLAN. 281 00:12:07,720 --> 00:12:10,920 OUR FEAR IS A LOT OF THE YOUNGER 282 00:12:10,920 --> 00:12:12,480 INVESTIGATORS HAVE DEPARTED TO 283 00:12:12,480 --> 00:12:14,000 COMPANIES AND A LOT OF COMPANIES 284 00:12:14,000 --> 00:12:18,600 ARE HIRING ALSO IN VIROLOGY AND 285 00:12:18,600 --> 00:12:20,600 THAT COULD IMPACT OR E.S.I. 286 00:12:20,600 --> 00:12:23,440 EFFORTS. 287 00:12:23,440 --> 00:12:24,920 >> UNDERSTOOD. 288 00:12:24,920 --> 00:12:27,080 WE FEEL THAT TOO, FRANKLY. 289 00:12:27,080 --> 00:12:27,640 WE'VE BEEN LOSING PEOPLE TO 290 00:12:27,640 --> 00:12:39,520 COMPANIES. 291 00:12:39,520 --> 00:12:42,600 >> ALSO ABOUT Ks. 292 00:12:42,600 --> 00:12:44,840 THE NUMBER OF K APPLICANTS, DO 293 00:12:44,840 --> 00:12:46,480 YOU HAVE INFORMATION ON THAT? 294 00:12:46,480 --> 00:12:47,000 >> NOT FOR THIS YEAR YET. 295 00:12:47,000 --> 00:12:48,280 >> OKAY. 296 00:12:48,280 --> 00:12:56,640 OTHER QUESTIONS? 297 00:12:56,640 --> 00:12:57,720 >> MONICA. 298 00:12:57,720 --> 00:13:00,760 >> ONE QUESTION IS THE BUILD 299 00:13:00,760 --> 00:13:01,600 BACK BETTER INITIATIVE 300 00:13:01,600 --> 00:13:03,560 INFRASTRUCTURE BILL, I'M 301 00:13:03,560 --> 00:13:04,800 WONDERING IF THERE ARE THOUGHTS 302 00:13:04,800 --> 00:13:07,160 WE COULD BRAIN STORM ON FOR 303 00:13:07,160 --> 00:13:09,320 BUILDING BACK NEXT GENERATION 304 00:13:09,320 --> 00:13:09,800 INVESTIGATORS? 305 00:13:09,800 --> 00:13:12,640 I REMEMBER FIVE YEARS AGO WHEN 306 00:13:12,640 --> 00:13:16,200 NIH LAUNCHED THE NEXT GENERATION 307 00:13:16,200 --> 00:13:17,800 INITIATIVE, IT WAS MET WITH A 308 00:13:17,800 --> 00:13:19,640 LOT OF ENTHUSIASM AT LEAST HERE 309 00:13:19,640 --> 00:13:22,840 AT UCSF BECAUSE WHAT IT ENDED UP 310 00:13:22,840 --> 00:13:24,720 DOING A LOT OF YOUNG 311 00:13:24,720 --> 00:13:27,520 INVESTIGATORS APPLIED FOR THINGS 312 00:13:27,520 --> 00:13:31,400 THAT WERE LOWER HANG AND COULD 313 00:13:31,400 --> 00:13:35,680 DO THAT BEFORE THE RO1s AND 314 00:13:35,680 --> 00:13:37,760 WONDER ABOUT ENCOURAGING 315 00:13:37,760 --> 00:13:40,480 NON-INVESTIGATORS TO APPLY FOR 316 00:13:40,480 --> 00:13:42,600 NON-R01s BEFORE THEY GET TO THE 317 00:13:42,600 --> 00:13:50,720 R01s AND RELAUGHING -- 318 00:13:50,720 --> 00:13:53,000 RELEASING THE KP LINE MAY HELP 319 00:13:53,000 --> 00:13:53,920 THEM RECOVER. 320 00:13:53,920 --> 00:13:55,920 >> I THINK WHAT WE'RE STRUGGLING 321 00:13:55,920 --> 00:13:58,080 WITH IS TRYING TO BALANCE 322 00:13:58,080 --> 00:14:07,080 E.S.I.s WITH DIVERSITY AS WELL 323 00:14:07,080 --> 00:14:10,520 WE HAVE A HIGHER PRIORITY TO 324 00:14:10,520 --> 00:14:14,680 PROMOTE DIVERSITY OVER BLANKET 325 00:14:14,680 --> 00:14:15,480 YOUNG INVESTIGATORS. 326 00:14:15,480 --> 00:14:16,320 WE'LL HAVE TO SEE WHAT WE CAN 327 00:14:16,320 --> 00:14:17,200 DO. 328 00:14:17,200 --> 00:14:21,320 >> THANK YOU. 329 00:14:21,320 --> 00:14:22,560 ANITA. 330 00:14:22,560 --> 00:14:24,720 >> JUST TO ADD TO THE CHORUS, 331 00:14:24,720 --> 00:14:26,720 YOU HEARD MY QUESTION TO FAUCI 332 00:14:26,720 --> 00:14:30,320 AS WELL, I THINK THIS IS A 333 00:14:30,320 --> 00:14:31,160 CRUCIAL ISSUE. 334 00:14:31,160 --> 00:14:36,600 WE'RE SEEING THE CHALLENGE OF 335 00:14:36,600 --> 00:14:43,520 RECRUITING TALENT AND HOW MANY 336 00:14:43,520 --> 00:14:49,600 ARE BEING SWAYED FOR PAY AND 337 00:14:49,600 --> 00:14:51,120 THEY'RE NOT GETTING FUNDED WITH 338 00:14:51,120 --> 00:14:53,440 K AWARDS OR THE TRANSITION. 339 00:14:53,440 --> 00:14:57,120 I HOPE WE CAN FIND WAYS TO 340 00:14:57,120 --> 00:14:58,720 INCENTIVIZE AND PROMOTE NEW 341 00:14:58,720 --> 00:15:00,440 PROGRAMS, NEW FUNDING STREAMS 342 00:15:00,440 --> 00:15:01,800 AND GIVE SUPPLEMENTS THAT WILL 343 00:15:01,800 --> 00:15:08,120 NOT TAKE A WHILE TO OBTAIN TO 344 00:15:08,120 --> 00:15:09,680 GET PEOPLE BACK. 345 00:15:09,680 --> 00:15:12,120 >> I THINK IT WOULD BE IMPORTANT 346 00:15:12,120 --> 00:15:19,320 FOR YOU ALL TO WRITE A LETTER TO 347 00:15:19,320 --> 00:15:20,400 MAUREEN ABOUT THIS. 348 00:15:20,400 --> 00:15:27,920 >> THE LETTER TO MAUREEN TO OAR 349 00:15:27,920 --> 00:15:30,720 WOULD BE HELP FFUL 350 00:15:30,720 --> 00:15:33,800 >> I THINK AIDS IS A UNIQUE 351 00:15:33,800 --> 00:15:36,000 SITUATION AND TO PUT EFFORT ON 352 00:15:36,000 --> 00:15:40,120 THIS WOULD BE USEFUL. 353 00:15:40,120 --> 00:15:41,800 THE OTHER IS IF YOU GOT COUNCILS 354 00:15:41,800 --> 00:15:44,320 FROM OTHER INSTITUTES TO DO THIS 355 00:15:44,320 --> 00:15:45,920 TOGETHER WITH YOU WOULD BE QUITE 356 00:15:45,920 --> 00:15:46,160 IMPORTANT. 357 00:15:46,160 --> 00:15:47,800 THAT WOULD BE MY SUGGESTION. 358 00:15:47,800 --> 00:15:48,880 >> OKAY. 359 00:15:48,880 --> 00:15:50,920 AND THE ONLY OTHER QUESTION I 360 00:15:50,920 --> 00:15:52,600 HAVE IS FROM LAST TIME YOU 361 00:15:52,600 --> 00:15:54,200 PRESENTED, I KNOW THERE'S A 362 00:15:54,200 --> 00:16:03,320 DELAY IN GETTING DATA FOR US TO 363 00:16:03,320 --> 00:16:05,640 REVIEW WHEN IT'S SEX 364 00:16:05,640 --> 00:16:06,240 DISAGGREGATED IS THERE A 365 00:16:06,240 --> 00:16:08,360 SOLUTION TO GET UPDATED DATA OR 366 00:16:08,360 --> 00:16:09,960 REAL TIME DATA. 367 00:16:09,960 --> 00:16:12,000 THIS IS GREAT HAVING THIS BUT 368 00:16:12,000 --> 00:16:15,840 NOT SURE HOW MUCH GRANULARITY 369 00:16:15,840 --> 00:16:16,400 WAS AVAILABLE. 370 00:16:16,400 --> 00:16:18,520 >> THIS DATA WAS CLEANED AND 371 00:16:18,520 --> 00:16:19,640 FINALIZED ABOUT A WEEK AGO. 372 00:16:19,640 --> 00:16:21,920 IT TAKES A LONG TIME AT THE END 373 00:16:21,920 --> 00:16:25,320 OF THE FISCAL YEAR AND WE CAN GO 374 00:16:25,320 --> 00:16:27,080 BACK AND LOOK AT '20 AND THAT 375 00:16:27,080 --> 00:16:29,600 WOULD BE WHERE WE WOULD BE. 376 00:16:29,600 --> 00:16:32,960 IT BECOMES A HISTORY LESSON. 377 00:16:32,960 --> 00:16:37,360 IT'S NOT REALLY USEFUL IN REAL 378 00:16:37,360 --> 00:16:40,120 TIME AND THAT'S THE REALITY. 379 00:16:40,120 --> 00:16:44,360 >> WE'LL TAKE THAT UP FROM THE 380 00:16:44,360 --> 00:16:46,080 COMMITTEE AND NOTE TO MAUREEN. 381 00:16:46,080 --> 00:16:51,760 >> THE IDEA IT'S NOT JUST US BUT 382 00:16:51,760 --> 00:16:54,160 OTHER COUNCILS. 383 00:16:54,160 --> 00:16:58,720 TRISH HAD HER HAND UP BUT PUT A 384 00:16:58,720 --> 00:17:01,120 LINK IN THE CHAT TO AN OAR 385 00:17:01,120 --> 00:17:01,720 DOCUMENT. 386 00:17:01,720 --> 00:17:04,120 >> I JUST WANTED TO SAY, CARL, 387 00:17:04,120 --> 00:17:05,320 THE EARLY STAGE INVESTIGATORS IS 388 00:17:05,320 --> 00:17:10,680 ONE THING WE'VE BEEN WORKING ON 389 00:17:10,680 --> 00:17:17,680 HARD FOR THE OAR AND WE HAVE ONE 390 00:17:17,680 --> 00:17:22,360 SPECIAL COMMITTEE ONE HIV AND 391 00:17:22,360 --> 00:17:23,800 COVID AND THERE'S BEEN WORK ON 392 00:17:23,800 --> 00:17:28,760 THAT AND I LISTED RESOURCES 393 00:17:28,760 --> 00:17:29,640 WE'RE PROVIDING AND THEY'RE 394 00:17:29,640 --> 00:17:31,480 COLLECTING THIS INFORMATION OVER 395 00:17:31,480 --> 00:17:36,960 THE ENTIRE NIH FOR EARLY STAGE 396 00:17:36,960 --> 00:17:37,320 INVESTIGATORS. 397 00:17:37,320 --> 00:17:38,480 I THINK MAYBE NEXT TIME WE 398 00:17:38,480 --> 00:17:40,320 SHOULD GET BECAUSE MY UPDATE 399 00:17:40,320 --> 00:17:42,440 DOESN'T INCLUDE THIS BECAUSE 400 00:17:42,440 --> 00:17:44,000 IT'S ONE OF THE TASK FORCE BUT 401 00:17:44,000 --> 00:17:48,000 MAYBE NEXT TIME IF YOU WANT TO 402 00:17:48,000 --> 00:17:51,520 GIVE SOMEONE THAT KIND OF AN 403 00:17:51,520 --> 00:17:52,760 UPDATE IT WILL BE OFFICIAL. 404 00:17:52,760 --> 00:17:54,160 >> WE'LL PUT THAT IN THE MINUTES 405 00:17:54,160 --> 00:17:56,480 AND FOLLOW-UP. 406 00:17:56,480 --> 00:17:57,440 THANK YOU, TRISH. 407 00:17:57,440 --> 00:17:58,320 IF THERE'S NO OTHER POINTS OF 408 00:17:58,320 --> 00:17:59,880 DISCUSSION ON THIS WE'LL MOVE ON 409 00:17:59,880 --> 00:18:02,720 TO SCIENTIFIC AND PROGRAMMATIC 410 00:18:02,720 --> 00:18:03,120 UPDATES. 411 00:18:03,120 --> 00:18:11,240 THIS HAS BEEN A GREAT YEAR. 412 00:18:11,240 --> 00:18:14,560 083 AND O84 DELIVERED RESULTS 413 00:18:14,560 --> 00:18:18,800 AND HAVE A LICENSED INJECTABLE 414 00:18:18,800 --> 00:18:21,080 FOR PREVENTION USABLE BY 415 00:18:21,080 --> 00:18:22,320 EVERYONE WHICH IS A REALLY 416 00:18:22,320 --> 00:18:27,120 IMPORTANT STEP FORWARD. 417 00:18:27,120 --> 00:18:28,480 HERE'S WHEN THEY OCCURRED IN 418 00:18:28,480 --> 00:18:31,400 JULY THE MEN'S STUDY REPORTED 419 00:18:31,400 --> 00:18:34,520 OUT IN NOVEMBER, THE WOMEN'S 420 00:18:34,520 --> 00:18:36,520 STUDY POINTED OUT IN BOTH CASES 421 00:18:36,520 --> 00:18:38,520 THEY ENDED UP BEING 422 00:18:38,520 --> 00:18:39,920 STATISTICALLY SUPERIOR THOUGH IT 423 00:18:39,920 --> 00:18:43,080 WAS A NON-INFERIORITY DESIGN 424 00:18:43,080 --> 00:18:45,200 THAT CROSSED THE MARGIN AND 425 00:18:45,200 --> 00:18:47,880 DEMONSTRATES SUPERIORITY IN BOTH 426 00:18:47,880 --> 00:18:50,200 TRIALS WHICH IS JUST INCREDIBLE 427 00:18:50,200 --> 00:19:04,240 TO GIVE A SENSE OF THE STRENGTH. 428 00:19:04,240 --> 00:19:07,320 AND THE FDA MADE A DECISION AND 429 00:19:07,320 --> 00:19:10,720 THE WAS WHEN THERE WAS SO MUCH 430 00:19:10,720 --> 00:19:12,560 COVID NEWS IT DIDN'T EVEN MAKE 431 00:19:12,560 --> 00:19:14,080 THE FRONT PAGE OF THE NEWSPAPER 432 00:19:14,080 --> 00:19:15,840 AND IT'S GREAT TO HAVE IT 433 00:19:15,840 --> 00:19:17,400 BECAUSE THEY CAN'T TAKE IT AWAY 434 00:19:17,400 --> 00:19:18,920 FROM US NOW AND WE'RE ALSO 435 00:19:18,920 --> 00:19:22,080 CONTINUING TO PUSH HARD ON 436 00:19:22,080 --> 00:19:24,320 MAKING SURE SPECIAL POPULATIONS 437 00:19:24,320 --> 00:19:25,920 CAN GAIN ACCESS. 438 00:19:25,920 --> 00:19:30,800 WE'RE COMPLETING STUDIES IN 439 00:19:30,800 --> 00:19:41,800 TEENS FOR AND WILL BRING THE AGE 440 00:19:41,800 --> 00:19:43,000 OF USE DOWN WHICH IS IMPORTANT 441 00:19:43,000 --> 00:20:04,520 AROUND THE GLOBE. 442 00:20:04,520 --> 00:20:15,560 AND THERE'S ONE ON HOUSEHOLDS 443 00:20:15,560 --> 00:20:18,000 TESTING AND THERE'S A STATIN 444 00:20:18,000 --> 00:20:20,240 VERSUS STANDARD OF CARE. 445 00:20:20,240 --> 00:20:22,960 FINISHING OUT THE STUDIES WE 446 00:20:22,960 --> 00:20:25,080 NEED TO DO ON THE RING WE'RE 447 00:20:25,080 --> 00:20:28,960 LOOKING AT AN OPEN-LABEL SAFETY 448 00:20:28,960 --> 00:20:34,200 TRIALS TO PROVIDE THE DATA 449 00:20:34,200 --> 00:20:44,880 NEEDED TO EXTEND USE AND WITH 450 00:20:44,880 --> 00:20:48,400 705 NOT MEETING END POINTS, 706 451 00:20:48,400 --> 00:20:51,520 HAS BEEN TOLD TO CONTINUE. 452 00:20:51,520 --> 00:20:55,040 THE VACCINES ARE DIFFERENT IN 453 00:20:55,040 --> 00:20:57,000 705 AND 706 AND WE'RE CONTINUING 454 00:20:57,000 --> 00:20:59,040 THE STUDY AND SEE WHAT WILL 455 00:20:59,040 --> 00:21:00,160 HAPPEN IN THE SPRING. 456 00:21:00,160 --> 00:21:05,120 ON THE COVID FRONT, ACTIVE 2 457 00:21:05,120 --> 00:21:07,440 CONTINUES TO BE A WORKHORSE FOR 458 00:21:07,440 --> 00:21:13,440 OUT PATIENT STUDIES HAVING 459 00:21:13,440 --> 00:21:18,680 DEMONSTRATED ACTIVITY FOR 460 00:21:18,680 --> 00:21:19,080 BRE-BIO. 461 00:21:19,080 --> 00:21:21,520 THE INTERFERON BETA IS ABOUT TO 462 00:21:21,520 --> 00:21:24,920 OPEN AND WE'RE GETTING READY TO 463 00:21:24,920 --> 00:21:27,680 OPEN A TRIAL WITH THE PROTEASE 464 00:21:27,680 --> 00:21:32,600 INHIBITOR SO THINGS ARE MOVING 465 00:21:32,600 --> 00:21:36,480 QUITE NICELY WITH ACTIV 2. 466 00:21:36,480 --> 00:21:39,440 THE MONOCLONAL ANTIBODIES. 467 00:21:39,440 --> 00:21:44,120 WE AT EUAs KEEPING IN MIND THE 468 00:21:44,120 --> 00:21:46,280 LILLY GENERATION AND REGENERON 469 00:21:46,280 --> 00:21:46,880 COMBINATION HAVE BEEN 470 00:21:46,880 --> 00:21:53,160 ESSENTIALLY ELIMINATED BY 471 00:21:53,160 --> 00:21:53,400 OMICRON. 472 00:21:53,400 --> 00:21:59,760 THEY ARE BOTH COMPANIES ARE 473 00:21:59,760 --> 00:22:02,920 WORKING ON OMICRON SPECIFIC BUT 474 00:22:02,920 --> 00:22:12,040 BROAD ANTIBODY TO GET AN EUA 475 00:22:12,040 --> 00:22:12,320 RE-ISSUED. 476 00:22:12,320 --> 00:22:16,000 LILY IS STARTING THEIR STUDY AND 477 00:22:16,000 --> 00:22:19,120 THE STATUS OF THE OTHERS ARE 478 00:22:19,120 --> 00:22:23,600 LISTED THERE. 479 00:22:23,600 --> 00:22:31,520 ON THE VACCINE FRONT, THE DATA 480 00:22:31,520 --> 00:22:33,520 FOR THE BOOST CONTINUES TO GROW 481 00:22:33,520 --> 00:22:35,240 AND PLEASED WHERE WE ARE IN THE 482 00:22:35,240 --> 00:22:36,360 STUDIES AND IT'S IMPORTANT WE 483 00:22:36,360 --> 00:22:41,640 START THINKING ABOUT NEXT 484 00:22:41,640 --> 00:22:44,320 GENERATION AND MUCOSAL IMMUNITY 485 00:22:44,320 --> 00:22:46,000 WELLS THE IMMUNITY WE GET GOOD 486 00:22:46,000 --> 00:22:47,600 THE mRNA. 487 00:22:47,600 --> 00:22:51,000 I THINK BEING ABLE TO GET 488 00:22:51,000 --> 00:22:56,920 SIGNIFICANT ANTIBODY AND MUCOSAAL 489 00:22:56,920 --> 00:22:58,520 SURFACE THE NOSE AND RESPIRATORY 490 00:22:58,520 --> 00:23:00,280 TRACT ARE IMPORTANT. 491 00:23:00,280 --> 00:23:01,680 THERE'S A RESEARCH PLAN BEING 492 00:23:01,680 --> 00:23:02,920 DEVELOPED ON THE VACCINE FRONT 493 00:23:02,920 --> 00:23:03,720 TO TAKE US TO THE NEXT 494 00:23:03,720 --> 00:23:14,600 GENERATION. 495 00:23:14,600 --> 00:23:17,720 NOW I NEED TO PRESENT THE SBIR 496 00:23:17,720 --> 00:23:18,360 CONTRACT TOPICS FOR THE YEAR AND 497 00:23:18,360 --> 00:23:19,720 THEN HAVE A VOTE ON THESE. 498 00:23:19,720 --> 00:23:25,120 WE HAVE TWO NEW ONES. 499 00:23:25,120 --> 00:23:27,120 THE PURPOSE IS THIS THERE'S A 500 00:23:27,120 --> 00:23:29,400 PORTION OF THE SBIR FUNDING THAT 501 00:23:29,400 --> 00:23:31,400 GOES OUT THROUGH GRANTS. 502 00:23:31,400 --> 00:23:34,120 THE SBIR CONTRACTS ALLOWS THE 503 00:23:34,120 --> 00:23:35,920 DIVISION TO THINK ABOUT WHAT THE 504 00:23:35,920 --> 00:23:37,920 UNMET SCIENTIFIC PRIORITIES ARE 505 00:23:37,920 --> 00:23:40,320 THAT COULD BE MET BY SMALL 506 00:23:40,320 --> 00:23:41,720 BUSINESSES AND ENCOURAGE 507 00:23:41,720 --> 00:23:42,800 SCIENTIFIC AND TECHNICAL 508 00:23:42,800 --> 00:23:45,600 INNOVATION IN THESE SPECIFICALLY 509 00:23:45,600 --> 00:23:46,720 IDENTIFIED AREAS. 510 00:23:46,720 --> 00:23:50,320 THIS YEAR WE HAVE ONE NEW TOPIC 511 00:23:50,320 --> 00:23:51,720 AND TWO FOR RE-ISSUE. 512 00:23:51,720 --> 00:23:52,480 WE'LL TALK ABOUT THE ONE THAT'S 513 00:23:52,480 --> 00:23:59,360 A NEW TOPIC. 514 00:23:59,360 --> 00:24:01,760 THESE THE POINT OF CARE ONES AND 515 00:24:01,760 --> 00:24:02,720 ADHERENCE ASSAYS AND THE SECOND 516 00:24:02,720 --> 00:24:05,440 WAS LOOKING AT ASSAYS TO 517 00:24:05,440 --> 00:24:07,920 DIFFERENTIATE HIV INFECTION FROM 518 00:24:07,920 --> 00:24:08,720 THIS AND THOSE ARE BEING 519 00:24:08,720 --> 00:24:17,200 REISSUED. 520 00:24:17,200 --> 00:24:19,000 ONE OF THE THINGS IS IMPORTANT 521 00:24:19,000 --> 00:24:20,520 IS WE BUILD A DATABASE THAT'S 522 00:24:20,520 --> 00:24:25,320 BIGGER AND MORE INCLUSIVE THAN 523 00:24:25,320 --> 00:24:27,000 WHAT WE'VE DONE IN THE PAST AND 524 00:24:27,000 --> 00:24:28,320 THERE ARE SO MANY VIRUSES AND 525 00:24:28,320 --> 00:24:34,240 STUDIES BEING ABLE TO TRACK THIS 526 00:24:34,240 --> 00:24:35,000 THAT CATEGORIZES THE STRAINS, 527 00:24:35,000 --> 00:24:40,800 YUM RESPONSES, THE KINDS OF 528 00:24:40,800 --> 00:24:44,320 THINGS DONE WITH THOSE WOULD 529 00:24:44,320 --> 00:24:47,640 BENEFIT THE FIELD BECAUSE WE'RE 530 00:24:47,640 --> 00:24:51,320 NOT THE ORGANIZATION WHO USES 531 00:24:51,320 --> 00:24:53,480 NON-PRESUME AN PRIMATES AND 532 00:24:53,480 --> 00:24:55,040 WE'RE LOOKING TO GET THIS STOOD 533 00:24:55,040 --> 00:25:02,920 UP AS AN SBIR OR CONTRACT. 534 00:25:02,920 --> 00:25:04,840 THIS IS TO ESTABLISH A PROJECT 535 00:25:04,840 --> 00:25:06,800 TEAM TO FIND THE CRITICAL DATA 536 00:25:06,800 --> 00:25:08,280 WE WISH TO COLLECT. 537 00:25:08,280 --> 00:25:10,000 DEVELOP IT INTO SOFTWARE PACKAGE 538 00:25:10,000 --> 00:25:11,440 BUT ALSO DEVELOP THE TOOLS AND 539 00:25:11,440 --> 00:25:14,120 TECHNOLOGIES TO GO OUT AND GET 540 00:25:14,120 --> 00:25:17,240 THE DATA AND CURATE AND THINK 541 00:25:17,240 --> 00:25:20,360 ABOUT THE RE-AGENT PROGRAM WITH 542 00:25:20,360 --> 00:25:22,760 THE ABILITY TO HAVE STRAINS AND 543 00:25:22,760 --> 00:25:26,200 APPROPRIATE RE-AGENTS WILL HELP 544 00:25:26,200 --> 00:25:28,000 BRING A LEVEL OF QUALITY CONTROL 545 00:25:28,000 --> 00:25:30,320 TO THE FIELD AND ULTIMATELY 546 00:25:30,320 --> 00:25:34,720 CREATE A WEBSITE FOR USER ACCESS 547 00:25:34,720 --> 00:25:36,120 AND USE. 548 00:25:36,120 --> 00:25:37,920 ALSO CONTINUE TO CURATE 549 00:25:37,920 --> 00:25:38,240 LITERATURE. 550 00:25:38,240 --> 00:25:39,720 I THINK IT WOULD BE INCREDIBLY 551 00:25:39,720 --> 00:25:45,080 VALUABLE TO THE FIELD. 552 00:25:45,080 --> 00:25:46,080 WE'LL STOP THERE AND WHILE YOU 553 00:25:46,080 --> 00:25:48,560 ALL ARE VOTING WE CAN TAKE A FEW 554 00:25:48,560 --> 00:25:55,600 MORE QUESTIONS. 555 00:25:55,600 --> 00:25:57,320 >> IF PEOPLE COULD VOTE THAT 556 00:25:57,320 --> 00:25:58,040 WOULD BE GREAT. 557 00:25:58,040 --> 00:25:58,640 ANY ADDITIONAL QUESTIONS FOR 558 00:25:58,640 --> 00:26:17,440 CARL? 559 00:26:17,440 --> 00:26:18,920 >> I DON'T HAVE A QUESTION BUT 560 00:26:18,920 --> 00:26:22,640 COMMENT AS A NON-HUMAN PRIMATE 561 00:26:22,640 --> 00:26:23,360 RESEARCHER I'M GLAD YOU'RE 562 00:26:23,360 --> 00:26:24,520 PROVIDING THIS INFORMATION AND 563 00:26:24,520 --> 00:26:25,080 COLLECTING THAT. 564 00:26:25,080 --> 00:26:29,360 I THINK THAT'S GOING TO BE A 565 00:26:29,360 --> 00:26:31,720 GREAT RESOURCE TO THE FIELDS. 566 00:26:31,720 --> 00:26:33,720 I'M VERY SUPPORTIVE OF THAT. 567 00:26:33,720 --> 00:26:34,000 THANK YOU. 568 00:26:34,000 --> 00:26:39,120 >> THANKS, TRISH. 569 00:26:39,120 --> 00:26:40,440 >> ALL RIGHT, WELL, SHALL WE GO 570 00:26:40,440 --> 00:26:46,640 ON THEN? 571 00:26:46,640 --> 00:26:48,680 >> LET'S NOVE TRISHA'S SLIDES 572 00:26:48,680 --> 00:26:52,200 AND WHAT SHE'S GOING TO PRESENT. 573 00:26:52,200 --> 00:26:57,560 >> RIGHT, TRICIA BURDO WITH THE 574 00:26:57,560 --> 00:26:57,880 UPDATE. 575 00:26:57,880 --> 00:26:58,440 >> THANK YOU. 576 00:26:58,440 --> 00:27:00,160 I FIRST WANT TO APOLOGIZE FOR 577 00:27:00,160 --> 00:27:05,720 NOT BEING ON SCREEN TODAY AND 578 00:27:05,720 --> 00:27:07,680 BEING A LITTLE HOARSE. 579 00:27:07,680 --> 00:27:11,000 I ACTUALLY HAVE COVID. 580 00:27:11,000 --> 00:27:12,720 I'LL START NOW. 581 00:27:12,720 --> 00:27:22,800 WE THAT'D 58th MEETING OF THE 582 00:27:22,800 --> 00:27:26,360 OARAC HELD VIRTUALLY AND THIS 583 00:27:26,360 --> 00:27:28,120 FEATURED A REPORT FROM THE 584 00:27:28,120 --> 00:27:31,560 DIRECTOR AND UPDATES FROM THE 585 00:27:31,560 --> 00:27:36,280 HIV, ARB AND OAI WORKING GROUPS 586 00:27:36,280 --> 00:27:38,320 AND PRESENTATION FROM THE CDC 587 00:27:38,320 --> 00:27:39,880 DIRECTOR AND UPDATE FROM THE 588 00:27:39,880 --> 00:27:40,800 WHITE HOUSE OFFICE OF NATIONAL 589 00:27:40,800 --> 00:27:49,520 AIDS POLICY. 590 00:27:49,520 --> 00:27:53,120 SO THE KEY OAR STRATEGIC 591 00:27:53,120 --> 00:27:54,240 ENGAGEMENTS INCLUDED WERE 48 592 00:27:54,240 --> 00:27:57,920 DOMESTIC SESSIONS THAT HAD BEEN 593 00:27:57,920 --> 00:28:01,080 HELD SINCE 2008, A SUMMARY 594 00:28:01,080 --> 00:28:02,320 REPORT WILL BE AVAILABLE ON 595 00:28:02,320 --> 00:28:05,000 OAR'S WEBSITE SOON FOR THAT. 596 00:28:05,000 --> 00:28:08,400 A REPORT OF NIH, EHE ACTIVITIES 597 00:28:08,400 --> 00:28:11,560 IN FY19 DEVELOPED BY THE NIH 598 00:28:11,560 --> 00:28:13,560 AIDS EXECUTIVE COMMITTEE ALSO 599 00:28:13,560 --> 00:28:15,520 AVAILABLE ON OAR WEBSITE. 600 00:28:15,520 --> 00:28:17,240 WE ALSO HAD STRATEGIC 601 00:28:17,240 --> 00:28:18,760 ENGAGEMENTS WITH CONGRESS, THE 602 00:28:18,760 --> 00:28:20,120 WHITE HOUSE, HHS AND OTHER 603 00:28:20,120 --> 00:28:24,080 LEADERS AT THE NIH AND THIS 604 00:28:24,080 --> 00:28:28,480 INCLUDES THE FY22 CONGRESSIONAL 605 00:28:28,480 --> 00:28:31,520 BUDGET AND NIH REPRESENTATION 606 00:28:31,520 --> 00:28:43,920 AND ON THE STEERING COMMITTEE. 607 00:28:43,920 --> 00:28:45,920 FY22 AIDS PROFESSIONAL BUDGET IS 608 00:28:45,920 --> 00:28:49,720 AVAILABLE ON THE OAR WEBSITE FOR 609 00:28:49,720 --> 00:28:50,320 REVIEW. 610 00:28:50,320 --> 00:28:52,080 PER LEGISLATION, THE PJ 611 00:28:52,080 --> 00:28:53,760 ESTIMATES FUNDING NECESSARY TO 612 00:28:53,760 --> 00:28:58,040 CARRY OUT NIH RESEARCH WITHOUT 613 00:28:58,040 --> 00:28:59,360 REGARD TO THE PROBABILITY THAT 614 00:28:59,360 --> 00:29:02,240 SUCH AMOUNTS WILL BE 615 00:29:02,240 --> 00:29:02,560 APPROPRIATED. 616 00:29:02,560 --> 00:29:09,280 SO THE FY2022 PJ BUDGET IS 617 00:29:09,280 --> 00:29:11,440 $3.875 BILLION AN INCREASE OF 618 00:29:11,440 --> 00:29:22,120 25% OVER THE FY2021 ESTIMATE. 619 00:29:22,120 --> 00:29:23,400 . 620 00:29:23,400 --> 00:29:28,200 SO DR. GOODNOW DISCUSSED NEW 621 00:29:28,200 --> 00:29:34,720 MEMBERS WE HAVE TWO NEW AD HOC 622 00:29:34,720 --> 00:29:35,000 MEMBERS. 623 00:29:35,000 --> 00:29:46,800 DR. METHS AND DR. TURNBULL. 624 00:29:46,800 --> 00:29:51,920 SO THE CDC DIRECTOR AND FORMER 625 00:29:51,920 --> 00:30:00,280 OAR CHAIR DR. WOLINSKI OUTLINED 626 00:30:00,280 --> 00:30:01,960 THE ROLE AND HOW THE CDC PLANS 627 00:30:01,960 --> 00:30:03,720 TO ADDRESS EACH PILLAR TO 628 00:30:03,720 --> 00:30:06,680 DIAGNOSE, TREAT, PREVENT AND 629 00:30:06,680 --> 00:30:09,120 RESPOND. 630 00:30:09,120 --> 00:30:12,320 ACROSS EACH PILLAR SHE STRESSED 631 00:30:12,320 --> 00:30:15,520 SOCIAL FACTORS THAT ACT AS 632 00:30:15,520 --> 00:30:32,600 BARRIERS TO IMPROVEMENT. 633 00:30:32,600 --> 00:30:34,520 WE HAD MR. HAROLD PHILLIPS OF 634 00:30:34,520 --> 00:30:36,040 THE OFFICE OF NATIONAL AIDS 635 00:30:36,040 --> 00:30:42,320 POLICY WHO DISCUSSED BIDEN 636 00:30:42,320 --> 00:30:44,280 ADMINISTRATION'S SUPPORT AND YUM 637 00:30:44,280 --> 00:30:46,360 DATES TO THE NATIONAL HIV 638 00:30:46,360 --> 00:30:55,520 STRATEGY AND INTERAGENCY 639 00:30:55,520 --> 00:30:56,640 COLLABORATION. 640 00:30:56,640 --> 00:31:01,200 ALL THE MEETING MINUTES ARE 641 00:31:01,200 --> 00:31:02,880 AVAILABLE ON THE WEBSITE AND THE 642 00:31:02,880 --> 00:31:07,960 NEXT MEETING WILL BE FEBRUARY 24 643 00:31:07,960 --> 00:31:10,200 AGAIN VIRTUAL AND ALSO HAVE AN 644 00:31:10,200 --> 00:31:11,960 ORIENTATION SESSION FOR THE NEW 645 00:31:11,960 --> 00:31:15,320 MEMBERS ON THE 23rd. 646 00:31:15,320 --> 00:31:15,880 THAT'S IT. 647 00:31:15,880 --> 00:31:17,200 THE ONE THING I SKIPPED OVER 648 00:31:17,200 --> 00:31:19,120 LAST WAS WE HAD UPDATES FROM THE 649 00:31:19,120 --> 00:31:21,280 TWO PANELS OF THE WORKING 650 00:31:21,280 --> 00:31:21,680 GROUPS. 651 00:31:21,680 --> 00:31:25,520 AGAIN, THIS IS ALL DETAILED FROM 652 00:31:25,520 --> 00:31:26,720 OAR IN THE HIV INFO GROUP. 653 00:31:26,720 --> 00:31:27,680 THAT'S IT. 654 00:31:27,680 --> 00:31:41,000 THANK YOU. 655 00:31:41,000 --> 00:31:42,560 >> I APPRECIATE ALL THE OUTREACH 656 00:31:42,560 --> 00:31:42,920 AND LISTENING. 657 00:31:42,920 --> 00:31:43,560 IT'S FANTASTIC. 658 00:31:43,560 --> 00:32:03,880 ANY QUESTIONS? 659 00:32:03,880 --> 00:32:10,040 >> WE'LL START WITH THE BASIC 660 00:32:10,040 --> 00:32:16,320 SCIENCES PROGRAM AND DIANA 661 00:32:16,320 --> 00:32:16,560 FINZI. 662 00:32:16,560 --> 00:32:19,600 >> GOOD AFTERNOON, EVERYONE. 663 00:32:19,600 --> 00:32:21,440 GOOD TO SEE YOU ALL. 664 00:32:21,440 --> 00:32:23,520 SO TODAY I'LL GIVE YOU AN 665 00:32:23,520 --> 00:32:25,520 OVERVIEW OF THE BASIC SCIENCES 666 00:32:25,520 --> 00:32:33,800 PROGRAM. 667 00:32:33,800 --> 00:32:34,800 SO LAST YEAR I SPENT A FEW 668 00:32:34,800 --> 00:32:37,200 MINUTES TALKING ABOUT THE IMPACT 669 00:32:37,200 --> 00:32:42,880 THAT SARS HAD ON OUR HIV WORK. 670 00:32:42,880 --> 00:32:48,160 THIS YEAR I'LL MENTION THE 671 00:32:48,160 --> 00:32:50,160 IMPACTS AND GIVE HIGHLIGHTS AN 672 00:32:50,160 --> 00:32:52,520 MENTION ANTICIPATED PRIORITIES 673 00:32:52,520 --> 00:32:55,400 AND FUTURE DIRECTS AND THE 674 00:32:55,400 --> 00:32:56,720 FUTURE INITIATIVE PROPOSALS 675 00:32:56,720 --> 00:32:59,400 PRESENTED AT FUTURE MEETINGS 676 00:32:59,400 --> 00:32:59,920 WITH YOU. 677 00:32:59,920 --> 00:33:02,920 SO MUCH OF WHAT WE AS THE BASIC 678 00:33:02,920 --> 00:33:05,400 SCIENCES PROGRAM DO IS SUPPORT 679 00:33:05,400 --> 00:33:09,360 THE REALLY EARLY STAGE SCIENCE. 680 00:33:09,360 --> 00:33:11,680 THE EARLY INDICATIONS OF WHAT 681 00:33:11,680 --> 00:33:13,760 MIGHT EVENTUALLY LEAD TO BREAKS 682 00:33:13,760 --> 00:33:14,200 THROUGH. 683 00:33:14,200 --> 00:33:15,920 OUR FOUNDATION ARE IN A LARGE 684 00:33:15,920 --> 00:33:18,600 NUMBER OF UNSOLICITED GRANTS AND 685 00:33:18,600 --> 00:33:21,320 ALSO SOLICIT GRANTS IN ORDER TO 686 00:33:21,320 --> 00:33:24,560 INDICATE DIRECTION AND AREAS. 687 00:33:24,560 --> 00:33:26,400 WE WORK WITH OTHER PROGRAMS AND 688 00:33:26,400 --> 00:33:28,840 THERAPEUTICS AND PREVENTION AND 689 00:33:28,840 --> 00:33:33,120 VACCINES AND WE OFTEN SEE OUR 690 00:33:33,120 --> 00:33:35,120 EARLY WORK IMPROVE IN THOSE 691 00:33:35,120 --> 00:33:35,440 AREAS. 692 00:33:35,440 --> 00:33:38,920 THE SPACE IS IN BETWEEN PROGRAMS 693 00:33:38,920 --> 00:33:40,360 CONTINUE TO BE A VERY IMPORTANT 694 00:33:40,360 --> 00:33:41,640 AREA IN THE BASIC SCIENCES 695 00:33:41,640 --> 00:33:43,920 PROGRAM AS WE WORK TO LEVERAGE 696 00:33:43,920 --> 00:33:45,720 RESOURCES WHEN WE THINK WORKING 697 00:33:45,720 --> 00:33:46,880 TOGETHER WILL LIKELY BRING 698 00:33:46,880 --> 00:33:48,560 INSIGHT AND ADVANCES. 699 00:33:48,560 --> 00:33:51,520 AS AN EXAMPLE THAT I'VE GIVEN 700 00:33:51,520 --> 00:33:57,360 BEFORE THAT YOU HEARD BEFORE, WE 701 00:33:57,360 --> 00:33:58,720 ENCOURAGE AND SUPPORT 702 00:33:58,720 --> 00:34:02,200 INVESTIGATORS WHO USUALLY WORK 703 00:34:02,200 --> 00:34:02,800 ON VACCINES TO FOCUS ON HIV 704 00:34:02,800 --> 00:34:07,040 CURE. 705 00:34:07,040 --> 00:34:07,920 REGARDLESS, OUR MAIN FOCUS 706 00:34:07,920 --> 00:34:10,960 CONTINUES TO BE GENERATING NEW 707 00:34:10,960 --> 00:34:14,080 IDEAS, SUPPORTING A WIDE BASE OF 708 00:34:14,080 --> 00:34:15,400 EXPLORATION AND FEEDING THE 709 00:34:15,400 --> 00:34:18,400 PIPELINE WITH DIVERSITY OF 710 00:34:18,400 --> 00:34:18,680 PROJECTS. 711 00:34:18,680 --> 00:34:21,480 SO I HOPE TO GIVE YOU A FEEL FOR 712 00:34:21,480 --> 00:34:22,920 THE GREAT BREADTH OF WHAT WE DO 713 00:34:22,920 --> 00:34:30,840 IN THE BASIC SCIENCES PROGRAM. 714 00:34:30,840 --> 00:34:35,360 OUR PROGRAM IS THE PATHOGENESIS 715 00:34:35,360 --> 00:34:37,720 AND BASIC RESEARCH BRANCH, THE 716 00:34:37,720 --> 00:34:41,680 TARGETED INTERVENTIONS BRANCH 717 00:34:41,680 --> 00:34:45,920 AND THE EPIDEMIOLOGY BRANCH. 718 00:34:45,920 --> 00:34:52,000 DEBT COLLECTIVELY WE OVERSEE 719 00:34:52,000 --> 00:34:55,280 550 GRANTS WITH AN ANNUAL BUDGET 720 00:34:55,280 --> 00:35:00,920 OF AROUND $380 MILLION AND 721 00:35:00,920 --> 00:35:02,520 CONTRACTS THAT PROVIDE SERVICE 722 00:35:02,520 --> 00:35:04,120 TO GRANTEES. 723 00:35:04,120 --> 00:35:05,840 AN EXAMPLE IS THE AIDS RE-AGENT 724 00:35:05,840 --> 00:35:18,800 PROGRAM YOU ALL KNOW AND LOVE. 725 00:35:18,800 --> 00:35:22,080 THE FOCUS IN BASIC SCIENCE IS 726 00:35:22,080 --> 00:35:23,080 MECHANISTIC WORK WITH ATTENTION 727 00:35:23,080 --> 00:35:24,920 TO LATENCY PERSISTENCE AND CURE 728 00:35:24,920 --> 00:35:27,080 AND TARGETED INVENTIONS WE HAVE 729 00:35:27,080 --> 00:35:29,320 AN INCREASE FOCUS ON 730 00:35:29,320 --> 00:35:30,160 NON-TRADITIONAL THERAPEUTICS 731 00:35:30,160 --> 00:35:32,520 SUCH AS GENE AND CELL-BASED 732 00:35:32,520 --> 00:35:34,880 THERAPIES AND BIOLOGICS AND RNA 733 00:35:34,880 --> 00:35:36,040 THERAPEUTICS AND ALSO CONTINUE 734 00:35:36,040 --> 00:35:38,760 TO WORK ON SPECIFIC INTERVENTION 735 00:35:38,760 --> 00:35:41,440 TO VALIDATE HIV TARGETS AND 736 00:35:41,440 --> 00:35:43,080 SMALL-MOLECULE INHIBITERS. 737 00:35:43,080 --> 00:35:45,880 IN EPIDEMIOLOGY, WE MAINTAINED 738 00:35:45,880 --> 00:35:49,680 WORK ON CLINICAL OUTCOMES OF HIV 739 00:35:49,680 --> 00:35:52,200 THROUGH LARGE COHORTS THROUGHOUT 740 00:35:52,200 --> 00:35:54,040 THE WORLD AND ELECTRONIC HEALTH 741 00:35:54,040 --> 00:35:55,880 RECORD RESEARCH. 742 00:35:55,880 --> 00:35:58,760 RECENTLY FOCUSSING MORE ON 743 00:35:58,760 --> 00:36:00,280 TUBERCULOSIS AND THE 744 00:36:00,280 --> 00:36:02,760 INTERSECTION OF T.B. AND HIV. 745 00:36:02,760 --> 00:36:05,400 THE EPIDEMIOLOGY BRANCH HAS ALSO 746 00:36:05,400 --> 00:36:06,400 EXPANDED SUPPORT OF NEW 747 00:36:06,400 --> 00:36:07,960 SURVEILLANCE APPROACHES TO 748 00:36:07,960 --> 00:36:10,600 IDENTIFY PEOPLE WHO ARE AT HIGH 749 00:36:10,600 --> 00:36:14,400 RISK OF INFECTION AND PEOPLE WHO 750 00:36:14,400 --> 00:36:15,560 ARE AT RISK OF INADEQUATE 751 00:36:15,560 --> 00:36:19,520 TREATMENT. 752 00:36:19,520 --> 00:36:26,080 THEN A RELATIVELY NEW AREA LED 753 00:36:26,080 --> 00:36:28,080 BY OUR TEAM IS THE NIH ROLE IN 754 00:36:28,080 --> 00:36:30,360 THE FEDERAL PROGRAM OF ENDING 755 00:36:30,360 --> 00:36:31,720 THE HIV EPIDEMIC. 756 00:36:31,720 --> 00:36:33,480 WE HAVE ESTABLISHED A 757 00:36:33,480 --> 00:36:35,320 PARTNERSHIP WITH OUR COLLEAGUES 758 00:36:35,320 --> 00:36:37,160 WITHIN THE NIH SO THE NATIONAL 759 00:36:37,160 --> 00:36:39,000 INSTITUTE OF MENTAL HEALTH AND 760 00:36:39,000 --> 00:36:41,640 THE OFFICE OF AIDS RESEARCH AS 761 00:36:41,640 --> 00:36:43,720 WELL AS WITH OUTSIDE AGENCIES 762 00:36:43,720 --> 00:36:55,640 SUCH AS THE CDC AND HRSA. 763 00:36:55,640 --> 00:36:58,440 OUR EFFORTS RESULTED IN BETTER 764 00:36:58,440 --> 00:36:59,000 ALIGNMENT ACROSS AGENCIES. 765 00:36:59,000 --> 00:37:00,720 YOU CAN SEE THE BREADTH OF THE 766 00:37:00,720 --> 00:37:09,000 WORK WE DO IS QUITE GREAT. 767 00:37:09,000 --> 00:37:13,200 IT RANGES AT SUBSCIENCE TO 768 00:37:13,200 --> 00:37:15,520 EPIDEMIOLOGY AND DOOIM 769 00:37:18,400 --> 00:37:19,280 DYNAMICS OF HIV TRANSMISSION 770 00:37:19,280 --> 00:37:29,320 BETWEEN PEOPLE. 771 00:37:29,320 --> 00:37:32,920 I HAVE GIVEN A BROAD OVERVIEW 772 00:37:32,920 --> 00:37:37,160 AND NOW WANT TO TOUCH ON 773 00:37:37,160 --> 00:37:37,480 HIGHLIGHTS. 774 00:37:37,480 --> 00:37:39,320 AS I MENTIONED LAST YEAR WE WERE 775 00:37:39,320 --> 00:37:42,400 DEEPLY ENGAGED IN SUPPORTING OUR 776 00:37:42,400 --> 00:37:44,040 COLLEAGUES IN THE DIVISION OF 777 00:37:44,040 --> 00:37:45,120 MICROBIOLOGY AND INFECTIOUS 778 00:37:45,120 --> 00:37:45,520 DISEASES. 779 00:37:45,520 --> 00:37:49,680 I NOTED WE WERE INVOLVED IN MANY 780 00:37:49,680 --> 00:37:50,320 NIH ACTIVITIES INCLUDING THOSE 781 00:37:50,320 --> 00:37:53,080 THAT ARE LISTED HERE. 782 00:37:53,080 --> 00:37:59,240 MOST IMPORTANTLY, EVERY MEMBER 783 00:37:59,240 --> 00:38:00,720 HAS CONTRIBUTED BEHIND THE 784 00:38:00,720 --> 00:38:04,600 SCENES WITH UNQUALIFIED 785 00:38:04,600 --> 00:38:06,040 ENTHUSIASM IN PROVIDING THE 786 00:38:06,040 --> 00:38:07,320 REQUESTED ASSISTANCE AT THE DROP 787 00:38:07,320 --> 00:38:07,840 A HAT. 788 00:38:07,840 --> 00:38:09,120 I'LL BEEN PROUD OF MY GROUP 789 00:38:09,120 --> 00:38:16,800 DURING THIS EXTRAORDINARY TIME. 790 00:38:16,800 --> 00:38:19,960 SO SIMILARLY, WE SAW OUR 791 00:38:19,960 --> 00:38:22,640 GRANTEES RISE TO THE OCCASION 792 00:38:22,640 --> 00:38:24,640 WITH AN OUTPOURING OF EAGERNESS 793 00:38:24,640 --> 00:38:26,120 TO CONTRIBUTE. 794 00:38:26,120 --> 00:38:31,000 I WANT TO GIVE ONE OF MANY 795 00:38:31,000 --> 00:38:31,480 EXAMPLES. 796 00:38:31,480 --> 00:38:34,000 MEMBRANE PROTEIN STRUCTURES ARE 797 00:38:34,000 --> 00:38:36,120 A BIG CHALLENGE TO STUDY OWING 798 00:38:36,120 --> 00:38:41,800 TO THEIR PARTIALLY HYDROPHOBIC 799 00:38:41,800 --> 00:38:43,240 SERVICES. 800 00:38:43,240 --> 00:38:44,120 THE BREAKTHROUGH CAME IN 2002 801 00:38:44,120 --> 00:38:45,400 FROM THE LAB AT THE UNIVERSITY 802 00:38:45,400 --> 00:38:48,520 OF ILLINOIS WITH THE DEVELOPMENT 803 00:38:48,520 --> 00:38:54,640 OF THE LIPID BIO LAYERS 8 TO 16 804 00:38:54,640 --> 00:38:59,360 NANO METERS IN DIAMETER IN 805 00:38:59,360 --> 00:39:02,280 SOLUTIONS BY THESE TWO 806 00:39:02,280 --> 00:39:06,520 ENCIRCLING ANDO PATHIC SCAFFOLD 807 00:39:06,520 --> 00:39:07,480 PROTEINS. 808 00:39:07,480 --> 00:39:09,440 THESE STRUCTURES CREATE A NATIVE 809 00:39:09,440 --> 00:39:10,880 LIKE MEMBRANE ENVIRONMENT TO 810 00:39:10,880 --> 00:39:13,160 ANCHOR PROTEINS AND ALLOW THE 811 00:39:13,160 --> 00:39:15,400 STUDY OF FULL LENGTH MEMBRANE 812 00:39:15,400 --> 00:39:15,720 PROTEINS. 813 00:39:15,720 --> 00:39:18,720 SO ONE OF OUR GRANTEES FROM 814 00:39:18,720 --> 00:39:21,280 HARVARD MEDICAL SCHOOL HAS BEEN 815 00:39:21,280 --> 00:39:24,520 USING THESE NANO DISCS FOR HIV 816 00:39:24,520 --> 00:39:25,640 STRUCTURES AND HERE ON THE 817 00:39:25,640 --> 00:39:28,920 BOTTOM LEFT IS AN EXAMPLE OF HIV 818 00:39:28,920 --> 00:39:33,000 ENVELOPE EMBEDDED IN THE NANO 819 00:39:33,000 --> 00:39:35,520 DISC AND NEXT TO IT THE SAME 820 00:39:35,520 --> 00:39:40,400 PROTEIN WITH AN ANTIBODY BOUND 821 00:39:40,400 --> 00:39:40,720 IT. 822 00:39:40,720 --> 00:39:44,680 WITH SARS HE WAS ABLE TO DO THIS 823 00:39:44,680 --> 00:39:52,480 AND HE PUBLISH THE SPIKE 824 00:39:52,480 --> 00:39:53,920 PROTEIN. 825 00:39:53,920 --> 00:39:58,080 THERE'S PREFUSION STATE ON THE 826 00:39:58,080 --> 00:40:00,160 LEFT OF THE SPIKE PROTEIN AND 827 00:40:00,160 --> 00:40:05,280 THE POST-FUSION THAT OCCURS WHEN 828 00:40:05,280 --> 00:40:06,520 IT BINDS AND FUSES. 829 00:40:06,520 --> 00:40:10,320 THE RECEPTOR BINDING DOMAIN ON 830 00:40:10,320 --> 00:40:12,640 TOP HERE BINDS AND OPENS UP AS 831 00:40:12,640 --> 00:40:14,880 PART OF THIS SPIKE FALLS OUT AND 832 00:40:14,880 --> 00:40:16,440 IN THIS PUBLICATION, THEY 833 00:40:16,440 --> 00:40:19,320 REPORTED A SIGNIFICANT 834 00:40:19,320 --> 00:40:21,800 ACCUMULATION OF THIS POST-FUSION 835 00:40:21,800 --> 00:40:26,320 STRUCTURE WHICH CAN HAPPEN 836 00:40:26,320 --> 00:40:26,640 SPONTANEOUSLY. 837 00:40:26,640 --> 00:40:32,480 AND IF IT HAPPENS BEFORE 838 00:40:32,480 --> 00:40:33,960 PREFUSION THEY'RE NOT FUNCTIONAL 839 00:40:33,960 --> 00:40:34,920 FOR ENTRY. 840 00:40:34,920 --> 00:40:37,120 AS VARIANTS EMERGED HE WAS ABLE 841 00:40:37,120 --> 00:40:39,320 TO APPLY THE SAME TECHNOLOGY AND 842 00:40:39,320 --> 00:40:42,000 MAKE MANY CRITICAL DISCOVERIES 843 00:40:42,000 --> 00:40:44,120 AND MENTOR SOME HARD-WORKING 844 00:40:44,120 --> 00:40:44,520 POST-DOC. 845 00:40:44,520 --> 00:40:49,120 YOU CAN SEE THE LIST THERE OF 846 00:40:49,120 --> 00:40:51,360 THE PAPERS THAT THEY PUBLISHED 847 00:40:51,360 --> 00:40:53,800 AND ARE PUBLISHING. 848 00:40:53,800 --> 00:40:56,200 SO IN THE NEXT SLIDE, I CAN SHOW 849 00:40:56,200 --> 00:40:58,200 YOU THE VERY SIMPLE CHANGE TO 850 00:40:58,200 --> 00:41:03,040 DESCRIBE AND THAT'S A CHANGE OF 851 00:41:03,040 --> 00:41:06,120 ONE AMINO ACID FROM THIS ACID TO 852 00:41:06,120 --> 00:41:10,040 GLYCINE ON AMINO ACID 614, 853 00:41:10,040 --> 00:41:11,440 ROUGHLY HALFWAY THROUGH THIS 854 00:41:11,440 --> 00:41:16,600 PROTEIN. 855 00:41:16,600 --> 00:41:20,840 IT'S JUST UNDER 1300 AMINO 856 00:41:20,840 --> 00:41:21,120 ACIDS. 857 00:41:21,120 --> 00:41:23,000 YOU PROBABLY RECALL ONE OF THE 858 00:41:23,000 --> 00:41:25,960 FIRST VARIANTS BEING THE D TO G 859 00:41:25,960 --> 00:41:29,040 MUTATION THAT RAPIDLY BECAME 860 00:41:29,040 --> 00:41:31,520 DOMINANT GLOBALLY EARLY IN 2020. 861 00:41:31,520 --> 00:41:36,080 SO WHEN THE GROUP MADE THIS ONE 862 00:41:36,080 --> 00:41:39,040 AMINO ACID CHANGE FROM B TO G 863 00:41:39,040 --> 00:41:41,520 THEY SAW THE TITER HOLDING IN 864 00:41:41,520 --> 00:41:44,600 THIS LOOP, THE 630 LOOP WHICH 865 00:41:44,600 --> 00:41:46,120 ALSO RESULTED IN GREATER 866 00:41:46,120 --> 00:41:47,120 STABILITY OF THIS COMBINED 867 00:41:47,120 --> 00:41:51,440 STRUCTURE WITH THE RECEPTOR 868 00:41:51,440 --> 00:41:56,720 BINDING DOMAIN UP FORMATION AND 869 00:41:56,720 --> 00:41:58,960 LESS STRUCTURES INDICATING THE 870 00:41:58,960 --> 00:42:02,800 SINGLE AMINO ACID STABILIZED 871 00:42:02,800 --> 00:42:04,480 THIS PREFUSION STAY. 872 00:42:04,480 --> 00:42:07,160 THEY WERE THERE BE ABLE TO GIVE 873 00:42:07,160 --> 00:42:08,680 A MECHANISTIC EXPLANATION 874 00:42:08,680 --> 00:42:16,400 SHOWING THE ONE AMINNOW -- AMINO 875 00:42:16,400 --> 00:42:18,040 ACID STRAIN LESS PRONE TO 876 00:42:18,040 --> 00:42:23,440 MISFIRING BEFORE BINDING TO THE 877 00:42:23,440 --> 00:42:26,840 DOMAIN AND REDUCED THE PREMATURE 878 00:42:26,840 --> 00:42:29,400 S1 SHEDDING AND INCREASING THE 879 00:42:29,400 --> 00:42:31,680 NUMBER OF TOTAL FUNCTIONAL S 880 00:42:31,680 --> 00:42:37,240 PROTEINS INCORPORATED. 881 00:42:37,240 --> 00:42:40,320 THISAND REDUCED THE PREMATURE S1 882 00:42:40,320 --> 00:42:41,400 SHEDDING AND INCREASING THE 883 00:42:41,400 --> 00:42:42,000 NUMBER OF TOTAL FUNCTIONAL S 884 00:42:42,000 --> 00:42:42,480 PROTEINS INCORPORATED. 885 00:42:42,480 --> 00:42:44,000 THIS THIS GAVE THE VIRUS HIGHER 886 00:42:44,000 --> 00:42:46,720 CHANCE TO INFECT. 887 00:42:46,720 --> 00:42:51,520 NOW GOING BACK TO THE HIV WORK 888 00:42:51,520 --> 00:42:54,120 AND HIGHLIGHTS. 889 00:42:54,120 --> 00:42:55,840 I TOUCHED ON ONE HIGHLIGHT THE 890 00:42:55,840 --> 00:42:57,520 SARS HIGHLIGHT HAVING TO DO WITH 891 00:42:57,520 --> 00:42:59,280 STRUCTURES AND MOLECULES SO FOR 892 00:42:59,280 --> 00:43:01,920 THE SAKE OF TIME ONLY ONE 893 00:43:01,920 --> 00:43:03,520 EXAMPLE ON THE LEVEL OF CELLULAR 894 00:43:03,520 --> 00:43:06,280 BIOLOGY AND ONE ON THE HUMAN 895 00:43:06,280 --> 00:43:12,080 SCALE OF EPIDEMIOLOGY. 896 00:43:12,080 --> 00:43:23,880 SO WE HAVE A PROVIRUS UNAFFECTED 897 00:43:23,880 --> 00:43:27,720 BY ANTIRETROVIRAL THERAPIES AND 898 00:43:27,720 --> 00:43:28,560 INVISIBLE TO THE IMMUNE SYSTEM 899 00:43:28,560 --> 00:43:31,320 AND THIS GRAPH SHOWS THE 900 00:43:31,320 --> 00:43:33,840 STABILITY OF THE FREQUENCY OF 901 00:43:33,840 --> 00:43:35,440 LATENTLY AFFECTED CELLS IN 902 00:43:35,440 --> 00:43:37,360 TREATED PEOPLE OVER TIME. 903 00:43:37,360 --> 00:43:38,360 EACH COLOR IS A DIFFERENT 904 00:43:38,360 --> 00:43:40,680 PERSON'S TRAJECTORY WITH A 905 00:43:40,680 --> 00:43:42,480 BALANCE BETWEEN 906 00:43:42,480 --> 00:43:44,760 SELF-PROLIFERATION AND -- CELL 907 00:43:44,760 --> 00:43:46,720 PROLIFERATION AND CELL DEATH AND 908 00:43:46,720 --> 00:43:50,320 YOU CAN SEE SOMETIMES THERE'S AN 909 00:43:50,320 --> 00:43:55,000 INCREASE IN THE LATENT RESERVOIR 910 00:43:55,000 --> 00:43:58,000 SO THE QUESTION IS WHAT CAN 911 00:43:58,000 --> 00:44:01,120 CAUSE THE LATENT CELLS TO 912 00:44:01,120 --> 00:44:07,520 PROLIFERATE RESULTING IN A 913 00:44:07,520 --> 00:44:09,440 LARGER VIRAL HOUSING. 914 00:44:09,440 --> 00:44:11,840 THERE'S FOUR POSSIBLE MECHANISMS 915 00:44:11,840 --> 00:44:19,520 THAT EACH NEED TO SEE THE 916 00:44:19,520 --> 00:44:19,880 PROLIFERATION. 917 00:44:19,880 --> 00:44:24,560 THE VIRUS IS CARRIED OVER TO THE 918 00:44:24,560 --> 00:44:25,000 PROGENY. 919 00:44:25,000 --> 00:44:29,000 WE HAVE A CD4 CELL WITH THE 920 00:44:29,000 --> 00:44:30,720 PROVIRUS DIVIDES SPONTANEOUSLY 921 00:44:30,720 --> 00:44:33,640 OR SOMETIMES IN RESPONSE TO 922 00:44:33,640 --> 00:44:36,560 CYTOKINES AND PROLIFERATION IS 923 00:44:36,560 --> 00:44:37,800 NON SPECIFIC. 924 00:44:37,800 --> 00:44:40,120 ON THE BOTTOM WE HAVE TWO 925 00:44:40,120 --> 00:44:42,960 DIFFERENT MECHANISMS WHEREBY A 926 00:44:42,960 --> 00:44:45,200 SPECIFIC CLONE CAN DIVIDE. 927 00:44:45,200 --> 00:44:47,520 HERE, A CLONAL POPULATION IS 928 00:44:47,520 --> 00:44:50,040 DRIVEN BY TWO DISTINCT 929 00:44:50,040 --> 00:44:50,320 MECHANISMS. 930 00:44:50,320 --> 00:44:54,720 A SPECIFIC T CELL RECEPTOR OR 931 00:44:54,720 --> 00:44:56,320 PRO-VIRUS INTEGRATED AT THE 932 00:44:56,320 --> 00:45:02,800 SPECIFIC SITE. 933 00:45:02,800 --> 00:45:04,840 ON THE LOWER LEFT ARE DIFFERENT 934 00:45:04,840 --> 00:45:11,440 T CELLS WITH A DIFFERENT 935 00:45:11,440 --> 00:45:21,480 RECEPTOR THIS IS SPECIFIC TO THE 936 00:45:21,480 --> 00:45:21,760 POPULATION. 937 00:45:21,760 --> 00:45:24,200 ON THE RIGHT THERE'S THREE CELLS 938 00:45:24,200 --> 00:45:26,320 WITH PROVIRUS INTEGRATED IN 939 00:45:26,320 --> 00:45:28,320 THREE SITES ON THE CHROMOSOMAL 940 00:45:28,320 --> 00:45:29,440 DNI. 941 00:45:29,440 --> 00:45:32,320 ONE IS INTEGRATED AN SITE THAT 942 00:45:32,320 --> 00:45:34,000 CELL DIVISION HAPPENS MORE 943 00:45:34,000 --> 00:45:34,320 FREQUENTLY. 944 00:45:34,320 --> 00:45:37,040 IN THIS CASE THE DYNAMIC IS 945 00:45:37,040 --> 00:45:41,000 SPECIFIC TO THIS PARTICULAR 946 00:45:41,000 --> 00:45:41,960 INTEGRATED PROVIRAL CLONAL 947 00:45:41,960 --> 00:45:42,280 POPULATION. 948 00:45:42,280 --> 00:45:45,800 TO REPEAT, WE HAVE CLONAL 949 00:45:45,800 --> 00:45:47,080 PROLIFERATION ON THE LOWER LEFT 950 00:45:47,080 --> 00:45:47,880 THAT'S SPECIFIC TO A PARTICULAR 951 00:45:47,880 --> 00:45:50,320 T CELL RECEPTOR AND ON THE LOWER 952 00:45:50,320 --> 00:45:54,520 RIGHT THAT IS SPECIFIC TO A 953 00:45:54,520 --> 00:45:55,520 PARTICULAR PROVIRAL INTEGRATION 954 00:45:55,520 --> 00:46:05,400 SITE. 955 00:46:05,400 --> 00:46:07,800 WE LEARNED ABOUT T CELL RECEPTOR 956 00:46:07,800 --> 00:46:11,480 MODE OF PROLIFERATION FROM 957 00:46:11,480 --> 00:46:13,040 SEVERAL PUBLICATIONS INCLUDING 958 00:46:13,040 --> 00:46:16,080 ONE WHERE THEY COMBINED FOUR 959 00:46:16,080 --> 00:46:25,360 EXPERIMENTAL METHODS. 960 00:46:25,360 --> 00:46:29,440 THE ASSAY AND T CELL RECEPTOR 961 00:46:29,440 --> 00:46:31,560 SEQUENCING AND VIRUS SPECIFIC 962 00:46:31,560 --> 00:46:35,440 PEPTIDE STIMULATION OF CD4 963 00:46:35,440 --> 00:46:40,840 CELLS. 964 00:46:40,840 --> 00:46:44,800 DISREGARD THE HIV INFECTION AND 965 00:46:44,800 --> 00:46:46,360 COLOR. 966 00:46:46,360 --> 00:46:47,880 IT DEPICTS WHAT HAPPENS AFTER 967 00:46:47,880 --> 00:46:53,200 THE T CELL ENCOUNTERS THE 968 00:46:53,200 --> 00:46:55,560 ANTIGEN SHOWN AS THE BLACK 969 00:46:55,560 --> 00:46:56,160 DASHED LINES. 970 00:46:56,160 --> 00:46:59,320 THE INITIAL ONE IS SMALL WITH 971 00:46:59,320 --> 00:47:02,480 THE FIRST ROUND OF ANTIGEN 972 00:47:02,480 --> 00:47:04,880 STIMULATION THE POPULATION 973 00:47:04,880 --> 00:47:05,760 INCREASES DUE TO CELL DIVISION 974 00:47:05,760 --> 00:47:09,240 AND THEN CONTRACTS AND A STABLE 975 00:47:09,240 --> 00:47:11,520 MEMORY POPULATION IS LEFT AS 976 00:47:11,520 --> 00:47:12,720 ANTIGEN IS CLEARED. 977 00:47:12,720 --> 00:47:14,720 WHEN THE MEMORY POPULATION 978 00:47:14,720 --> 00:47:16,600 ENCOUNTERS THAT ANTIGEN AGAIN, 979 00:47:16,600 --> 00:47:18,960 IT FURTHER PROLIFERATES. 980 00:47:18,960 --> 00:47:22,440 THIS IS NORMAL IMMUNE SYSTEM 981 00:47:22,440 --> 00:47:26,920 PHYSIOLOGY WHERE CELLS 982 00:47:26,920 --> 00:47:30,520 PROLIFERATE WITH EXPOSURE TO THE 983 00:47:30,520 --> 00:47:31,120 COGNATE. 984 00:47:31,120 --> 00:47:31,760 NOW WHICH IS WHAT HAPPENS IN THE 985 00:47:31,760 --> 00:47:35,320 PRESENCE OF HIV IN ORANGE. 986 00:47:35,320 --> 00:47:39,920 ON THE LEFT IT SOME CELLS GET 987 00:47:39,920 --> 00:47:42,120 INFECTED WITH HIV. 988 00:47:42,120 --> 00:47:42,880 THE INITIAL HIV INTEGRATION 989 00:47:42,880 --> 00:47:45,280 EVENT IS SHOWN BY THE ORANGE 990 00:47:45,280 --> 00:47:45,880 ARROW. 991 00:47:45,880 --> 00:47:48,800 NOT ALL THESE MEMORY CELLS GET 992 00:47:48,800 --> 00:47:50,360 INFECTED WITH HIV. 993 00:47:50,360 --> 00:47:51,840 THE T CELL RECEPTOR CLONAL 994 00:47:51,840 --> 00:47:54,680 POPULATION THERE ON THE LEFT IS 995 00:47:54,680 --> 00:47:58,800 MIXED SOME INFECTED CELLS 996 00:47:58,800 --> 00:48:01,880 DEPICTED IN ORANGE AND SOME 997 00:48:01,880 --> 00:48:07,400 REMAINING UNAAFFECTED -- 998 00:48:07,400 --> 00:48:10,320 UNAFFECTED IN RIGHT AND SHORTLY 999 00:48:10,320 --> 00:48:12,440 AFTER THE CD4 CELL ENCOUNTERS 1000 00:48:12,440 --> 00:48:15,520 ANTIGEN IT'S INFECTED WITH HIV. 1001 00:48:15,520 --> 00:48:18,120 INSTEAD IN THIS CASE THE 1002 00:48:18,120 --> 00:48:22,320 INTEGRATION OCCURRED EARLY AFTER 1003 00:48:22,320 --> 00:48:24,200 THE CELL SAW ANTIGEN. 1004 00:48:24,200 --> 00:48:26,800 IN THIS CASE ON THE RIGHT, ALL 1005 00:48:26,800 --> 00:48:28,960 OF THE FUTURE PROGENY OF THE T 1006 00:48:28,960 --> 00:48:31,160 CELL RECEPTOR CLONE WILL CARRY 1007 00:48:31,160 --> 00:48:38,520 PROVIRUS. 1008 00:48:38,520 --> 00:48:41,400 IT'S THROUGH THESE TYPES OF 1009 00:48:41,400 --> 00:48:43,680 STUDIES WE'RE GATHERING A BER 1010 00:48:43,680 --> 00:48:45,400 INFORMATION OF BIOLOGY OF WHAT 1011 00:48:45,400 --> 00:48:50,560 DRIVES HIV PERSISTENCE. 1012 00:48:50,560 --> 00:48:53,080 SO NOW MOVING ON TO THE 1013 00:48:53,080 --> 00:48:54,640 POPULATION LEVEL HIGHLIGHT, WE 1014 00:48:54,640 --> 00:48:57,040 HAVE AN EXAMPLE OF AN IMPORTANT 1015 00:48:57,040 --> 00:49:01,400 BINDING FROM OUR LIMITED 1016 00:49:01,400 --> 00:49:04,320 INTERACTION TARGETED 1017 00:49:04,320 --> 00:49:16,720 EPIDEMIOLOGY GRANTS THE ACRONYM 1018 00:49:16,720 --> 00:49:20,120 LITE AND THIS IS LOOKING AT HIV 1019 00:49:20,120 --> 00:49:21,080 INFECTION IN THE UNITED STATES. 1020 00:49:21,080 --> 00:49:24,360 SO THIS PAPER WITH THE TITLE THE 1021 00:49:24,360 --> 00:49:26,800 CRISIS WE'RE NOT TALKING ABOUT 1022 00:49:26,800 --> 00:49:29,320 ONE IN THREE HIV CONVERSIONS 1023 00:49:29,320 --> 00:49:32,200 AMONG SEXUAL AND GENDER 1024 00:49:32,200 --> 00:49:36,120 MINORITIES WERE PERSISTENT 1025 00:49:36,120 --> 00:49:38,000 METHAMPHETAMINE USERS DESCRIBES 1026 00:49:38,000 --> 00:49:48,240 A STUDY ENROLLED OVER 36,000 MSM 1027 00:49:48,240 --> 00:49:51,120 WITH 5,000 COMPLETING BASELINE 1028 00:49:51,120 --> 00:49:55,120 AND NEAR YEAR FOLLOW-UP STUDIES 1029 00:49:55,120 --> 00:49:58,360 AND THE AUTHORS FOUND THAT HIV 1030 00:49:58,360 --> 00:50:01,920 VULNERABILITY INTERSECTS WITH 1031 00:50:01,920 --> 00:50:03,120 METH USE. 1032 00:50:03,120 --> 00:50:07,280 THEY WERE STRIKING SEVEN FOLD 1033 00:50:07,280 --> 00:50:11,440 INCREASE RISK OF HIV COMPARED TO 1034 00:50:11,440 --> 00:50:12,640 NON-USERS. 1035 00:50:12,640 --> 00:50:15,120 AMONG OTHER IMPORTANT FINDINGS 1036 00:50:15,120 --> 00:50:18,000 THEY FOUND BLACK MSM WERE THREE 1037 00:50:18,000 --> 00:50:21,680 TIMES INCREASED RISK COMPARED TO 1038 00:50:21,680 --> 00:50:30,480 WHITE MSM. 1039 00:50:30,480 --> 00:50:34,640 NOW FOCUSSING NOW I WANT TO 1040 00:50:34,640 --> 00:50:35,600 FOCUS ON FUTURE DIRECTION AND GO 1041 00:50:35,600 --> 00:50:37,160 BACK TO THE STUDIES AGAIN AND WE 1042 00:50:37,160 --> 00:50:39,520 HAVE RECEIVED APPLICATIONS FOR 1043 00:50:39,520 --> 00:50:43,000 THE CENTERS FOR HIV STRUCTURAL 1044 00:50:43,000 --> 00:50:43,560 BIOLOGY. 1045 00:50:43,560 --> 00:50:45,440 YOU MAY RECALL THESE CENTERS 1046 00:50:45,440 --> 00:50:49,000 WERE TRANSFERRED FROM NIGMS TO 1047 00:50:49,000 --> 00:50:50,880 NIAID TWO YEARS AGO AND WE'RE 1048 00:50:50,880 --> 00:50:51,800 SUPER EXCITED TO SEE THE RESULTS 1049 00:50:51,800 --> 00:50:54,760 OF THE REVIEWS AND THE FUTURE 1050 00:50:54,760 --> 00:50:55,360 STUDIES THAT WILL BE FUNDING 1051 00:50:55,360 --> 00:51:00,480 UNDER NIAID. 1052 00:51:00,480 --> 00:51:05,360 ALSO VERY EXCITING FOR US, IN 1053 00:51:05,360 --> 00:51:07,120 2021 WE WERE ABLE TO INCREASE OF 1054 00:51:07,120 --> 00:51:09,360 OUR FLAGSHIP FUNDING FOCUSSED ON 1055 00:51:09,360 --> 00:51:11,680 FIND CURE FOR HIV AND INCREASED 1056 00:51:11,680 --> 00:51:15,200 THE NUMBER OF MARTIN DELANEY 1057 00:51:15,200 --> 00:51:16,880 COLLABORATORIES TO 10 GROUPS. 1058 00:51:16,880 --> 00:51:20,280 THE SIX NEW ONES HAVE THE DARKER 1059 00:51:20,280 --> 00:51:21,160 BACKGROUND AND WITH THE 1060 00:51:21,160 --> 00:51:22,320 EXPANSION WE'VE BEEN ABLE TO 1061 00:51:22,320 --> 00:51:25,400 INCREASE THE RATIO OF FEMALES TO 1062 00:51:25,400 --> 00:51:27,720 MALES IN LEADERSHIP POSITIONS. 1063 00:51:27,720 --> 00:51:30,960 WE NOW HAVE 10 FEMALES IN BOLD 1064 00:51:30,960 --> 00:51:46,120 AND 15 MALES. 1065 00:51:46,120 --> 00:51:50,280 TO GIVE ONE EXAMPLE OF A FUTURE 1066 00:51:50,280 --> 00:51:51,000 SCIENTIFIC DIRECTION HOUSED 1067 00:51:51,000 --> 00:51:53,440 WITHIN THE MARTIN DELANEYS AS 1068 00:51:53,440 --> 00:51:55,840 WELL AS OTHER AWARDED GRANTS, WE 1069 00:51:55,840 --> 00:51:59,800 HAVE GENE THERAPY STUDIES AIMED 1070 00:51:59,800 --> 00:52:00,680 AT CURING HIV. 1071 00:52:00,680 --> 00:52:03,240 AMONG THE STRATEGIES WE AIM TO 1072 00:52:03,240 --> 00:52:06,880 GENERATE RESISTANT CELLS AND 1073 00:52:06,880 --> 00:52:08,360 ENHANCE HIV CELLULAR IMMUNE 1074 00:52:08,360 --> 00:52:10,400 RESPONSES, DIRECTLY TARGET PRO 1075 00:52:10,400 --> 00:52:12,680 VIRUS AND ALSO FIND EFFECTIVE 1076 00:52:12,680 --> 00:52:13,960 WAYS TO DELIVER BIOLOGICAL 1077 00:52:13,960 --> 00:52:17,320 MOLECULES. 1078 00:52:17,320 --> 00:52:18,360 NOW, TO GAIN ADDITIONAL STRIDES 1079 00:52:18,360 --> 00:52:21,200 IN THIS AREA, WE HAVE JOINED 1080 00:52:21,200 --> 00:52:22,800 FORCES WITH THE NATIONAL 1081 00:52:22,800 --> 00:52:25,600 INSTITUTE OF HEART, LUNG AND 1082 00:52:25,600 --> 00:52:27,520 BLOOD AS WELL AS THE NIH OFFICE 1083 00:52:27,520 --> 00:52:33,120 OF THE DIRECTOR. 1084 00:52:33,120 --> 00:52:34,880 SO NOW MOVING ON TO 1085 00:52:34,880 --> 00:52:40,040 EPIDEMIOLOGY. 1086 00:52:40,040 --> 00:52:42,760 WE WILL CONTINUE THROUGH OUR 1087 00:52:42,760 --> 00:52:47,480 CENTERS FOR AIDS RESEARCH, OUR 1088 00:52:47,480 --> 00:52:49,720 ACTIVE PARTICIPATION IN THE 1089 00:52:49,720 --> 00:52:51,320 ENDING THE HIV EPIDEMIC 1090 00:52:51,320 --> 00:52:51,640 INITIATIVE. 1091 00:52:51,640 --> 00:52:53,160 OUR ROLE AT THE NIH, IS TO 1092 00:52:53,160 --> 00:52:55,520 DETERMINE HOW BEST TO GET 1093 00:52:55,520 --> 00:52:57,720 EFFECTIVE PREVENTION AND 1094 00:52:57,720 --> 00:52:59,320 TREATMENT TOOLS TO THE PEOPLE 1095 00:52:59,320 --> 00:53:01,080 THAT NEED THEM THROUGH 1096 00:53:01,080 --> 00:53:01,720 IMPLEMENTATION RESEARCH IN 1097 00:53:01,720 --> 00:53:02,320 COLLABORATION WITH COMMUNITY 1098 00:53:02,320 --> 00:53:05,640 PARTNERS. 1099 00:53:05,640 --> 00:53:07,760 AND TO DEVELOP GENERALIZABLE 1100 00:53:07,760 --> 00:53:09,880 KNOWLEDGE FROM LOCAL KNOWLEDGE 1101 00:53:09,880 --> 00:53:16,480 TO OPTIMIZE IMPLEMENTING BEST 1102 00:53:16,480 --> 00:53:16,920 PRACTICES. 1103 00:53:16,920 --> 00:53:19,520 NOW, THIS SLIDE SUMMARIZES OUR 1104 00:53:19,520 --> 00:53:21,520 FUNDING TO DATE FOR SUPPORT TO 1105 00:53:21,520 --> 00:53:27,160 THE EHE INITIATIVE THROUGH THE 1106 00:53:27,160 --> 00:53:31,160 NIH AND THE FUNDING 1107 00:53:31,160 --> 00:53:33,720 ANNOUNCEMENTS WERE DEVELOPED IN 1108 00:53:33,720 --> 00:53:37,960 COLLABORATION WITH CDC AND HRSA 1109 00:53:37,960 --> 00:53:38,320 COLLEAGUES. 1110 00:53:38,320 --> 00:53:40,840 I WANT TO DRAW YOUR ATTENTION TO 1111 00:53:40,840 --> 00:53:43,920 THE 2021 WHERE WE FUNDED 36 1112 00:53:43,920 --> 00:53:46,080 AWARDS TO ADDRESS THE EHE 1113 00:53:46,080 --> 00:53:47,920 PRIORITIES THAT MEET THE LOCAL 1114 00:53:47,920 --> 00:53:49,760 NEEDS AND INVOLVE COLLABORATION 1115 00:53:49,760 --> 00:53:51,240 WITH IMPLEMENTING PARTNERS SUCH 1116 00:53:51,240 --> 00:53:54,920 AS THE HEALTH DEPARTMENTS AND 1117 00:53:54,920 --> 00:53:56,400 RYAN WHITE CLINICS. 1118 00:53:56,400 --> 00:53:58,280 A QUARTER INVOLVE THE 1119 00:53:58,280 --> 00:54:00,240 PARTNERSHIP WITH THE 1120 00:54:00,240 --> 00:54:02,120 HISTORICALLY BLACK COLLEGES AND 1121 00:54:02,120 --> 00:54:02,520 UNIVERSITIES AND 1122 00:54:02,520 --> 00:54:08,680 MINORITY-SERVING INSTITUTIONS. 1123 00:54:08,680 --> 00:54:15,720 SO ALSO IN THE AREA OF 1124 00:54:15,720 --> 00:54:18,960 EPIDEMIOLOGY, WITH U.S. BASED 1125 00:54:18,960 --> 00:54:22,520 FOCUSSED EPIDEMIOLOGY AS WE 1126 00:54:22,520 --> 00:54:24,600 DISCUSSED THE LITE APPLICATION 1127 00:54:24,600 --> 00:54:28,080 MOSTLY ON MSM, WE WERE ASKED 1128 00:54:28,080 --> 00:54:30,160 WHAT WE WERE DOING GAIN 1129 00:54:30,160 --> 00:54:31,720 INFORMATION ON WOMEN WITH 1130 00:54:31,720 --> 00:54:35,440 PARTICULAR CONCERN FOR MINORITY 1131 00:54:35,440 --> 00:54:35,840 WOMEN. 1132 00:54:35,840 --> 00:54:38,280 THIS IS FOCUSSED ON THE EPIDEMIC 1133 00:54:38,280 --> 00:54:39,680 AMONG WOMEN IN THE UNITED STATES 1134 00:54:39,680 --> 00:54:44,640 AND HAS RECEIVED SUPPORT ACROSS 1135 00:54:44,640 --> 00:54:46,840 NIH INSTITUTES AND OFFICES. 1136 00:54:46,840 --> 00:54:48,360 SIMILAR TO THE LITE INITIATIVES 1137 00:54:48,360 --> 00:54:51,200 FOR MSM, WE USE DIGITAL 1138 00:54:51,200 --> 00:54:55,000 APPROACHES TO ENROLL, RETAIN AND 1139 00:54:55,000 --> 00:54:59,320 ANALYZE INDIVIDUAL DATA TO HELP 1140 00:54:59,320 --> 00:55:01,400 IDENTIFY WOMEN VULNERABLE TO HIV 1141 00:55:01,400 --> 00:55:03,280 AND FIND NOVEL WAYS TO REDUCE 1142 00:55:03,280 --> 00:55:09,640 THIS VULNERABILITY. 1143 00:55:09,640 --> 00:55:11,480 FINAL 1144 00:55:11,480 --> 00:55:14,520 FINALLY MY LAST EXAMPLE IS ON 1145 00:55:14,520 --> 00:55:17,240 THE GLOBAL SCALE AND DATABASE TO 1146 00:55:17,240 --> 00:55:19,360 EVALUATE AIDS IT'S A CONSORTIUM 1147 00:55:19,360 --> 00:55:21,760 THAT COLLECTS DATA ON OVER 2 1148 00:55:21,760 --> 00:55:23,360 MILLION PATIENTS AT 430 CLIN 1149 00:55:23,360 --> 00:55:25,760 INNINGS AROUND THE WORLD. 1150 00:55:25,760 --> 00:55:27,640 IN ADDITION TO -- CLINICS AROUND 1151 00:55:27,640 --> 00:55:30,360 THE WORLD IN ADDITION TO 1152 00:55:30,360 --> 00:55:31,520 TREATMENT AND OUTCOMES THEY 1153 00:55:31,520 --> 00:55:33,320 CONTINUE TO GROW THEIR DATA 1154 00:55:33,320 --> 00:55:35,040 SCIENCE SKILLS IN THE EASE OF 1155 00:55:35,040 --> 00:55:39,920 MOVING DATA FROM THE CLINIC TO 1156 00:55:39,920 --> 00:55:40,960 ANALYSIS. 1157 00:55:40,960 --> 00:55:51,120 THE RECENT ADDITION OF SITE ARE 1158 00:55:51,120 --> 00:55:53,400 FOCUSSED ON SPECIFIC POPULATIONS 1159 00:55:53,400 --> 00:55:54,920 SUCH AS ADOLESCENTS, YOUNG ADULT 1160 00:55:54,920 --> 00:55:56,480 OR CHILDREN TO MEASURE FACTORS 1161 00:55:56,480 --> 00:56:05,400 ON A MORE GRANULAR LEVEL. 1162 00:56:05,400 --> 00:56:07,320 TOE SUMMARIZE IN THE BASIC 1163 00:56:07,320 --> 00:56:09,440 SCIENCES AND TARGETED 1164 00:56:09,440 --> 00:56:11,320 INTERVENTIONS WE AIM TO 1165 00:56:11,320 --> 00:56:15,720 STRENGTHEN AND RE-INVIGORATE 1166 00:56:15,720 --> 00:56:19,440 WORK ON STRUCTURAL VIROLOGY AND 1167 00:56:19,440 --> 00:56:26,760 IMMUNOLOGY ON ELIMINATING 1168 00:56:26,760 --> 00:56:27,560 RESIDUAL RESERVOIRS. 1169 00:56:27,560 --> 00:56:31,520 IN EPI, WE'RE PARTNERING WITH 1170 00:56:31,520 --> 00:56:33,600 OTHER INSTITUTES ON OUTCOMES AND 1171 00:56:33,600 --> 00:56:35,040 GAINING AN INCREASE IN 1172 00:56:35,040 --> 00:56:37,160 UNDERSTANDING TRANSMISSIONS AND 1173 00:56:37,160 --> 00:56:45,120 SUPPORT STUDIES TOWARDS EHE. 1174 00:56:45,120 --> 00:56:48,240 I WANT TO END BY THANKING MY 1175 00:56:48,240 --> 00:56:50,120 COLLEAGUES AND AGAIN EXPRESSING 1176 00:56:50,120 --> 00:56:52,640 MY APPRECIATION AND WORKING WITH 1177 00:56:52,640 --> 00:56:57,760 A WONDERFUL GROUP OF COMMITTED 1178 00:56:57,760 --> 00:56:58,120 PEOPLE. 1179 00:56:58,120 --> 00:56:59,880 AND FOR A MOMENT I'D LIKE YOU TO 1180 00:56:59,880 --> 00:57:01,560 FOCUS YOUR ATTENTION ON THE 1181 00:57:01,560 --> 00:57:02,320 THREE PEOPLE IN THE UPPER RIGHT 1182 00:57:02,320 --> 00:57:04,880 HAND CORNER. 1183 00:57:04,880 --> 00:57:11,640 I WANT TO THANK ANN AND JASON 1184 00:57:11,640 --> 00:57:14,200 WHO HELP US STAY FOCUSSED AND 1185 00:57:14,200 --> 00:57:16,880 TONY WHO AFTER 17 YEARS OF TRULY 1186 00:57:16,880 --> 00:57:18,600 OUTSTANDING SERVICE WILL RETIRE 1187 00:57:18,600 --> 00:57:19,120 NEXT MONTH. 1188 00:57:19,120 --> 00:57:23,040 WE WILL MISS HIM AN HIS DEEP AND 1189 00:57:23,040 --> 00:57:25,800 BROAD KNOWLEDGE ABOUT HIV. 1190 00:57:25,800 --> 00:57:27,560 THANK YOU ALL FOR YOUR ATTENTION 1191 00:57:27,560 --> 00:57:30,800 AND I'M HAPPY ANSWER ANY 1192 00:57:30,800 --> 00:57:35,240 QUESTIONS. 1193 00:57:35,240 --> 00:57:35,800 >> THANK YOU. 1194 00:57:35,800 --> 00:57:45,840 THAT WAS GREAT. 1195 00:57:45,840 --> 00:57:47,680 IT'S GREAT TO SEE AWARE AT THIS 1196 00:57:47,680 --> 00:57:53,120 POINT AND MANY REMEMBER THE 1197 00:57:53,120 --> 00:57:55,520 DISCUSSION WE WERE IMPRESSED AS 1198 00:57:55,520 --> 00:57:56,800 PEOPLE DESCRIBED LITE AND THEN 1199 00:57:56,800 --> 00:57:59,080 WE SAID WHAT ABOUT WOMEN AND 1200 00:57:59,080 --> 00:58:02,360 WOMEN OF COLOR AND THE 1201 00:58:02,360 --> 00:58:12,720 DISCUSSION STARTED AND YOU SAID 1202 00:58:12,720 --> 00:58:13,120 WE' 1203 00:58:13,120 --> 00:58:16,960 WE'RE THINK ING ABOUT IT AND WE 1204 00:58:16,960 --> 00:58:19,280 ARE NOT PEOPLE WHO NEED 1205 00:58:19,280 --> 00:58:21,760 IMMEDIATE GRATIFICATION AND IT'S 1206 00:58:21,760 --> 00:58:25,840 GREAT TO SEE IDEAS TURN INTO 1207 00:58:25,840 --> 00:58:27,040 PROPOSALS AND RESULTS. 1208 00:58:27,040 --> 00:58:27,640 THANK YOU. 1209 00:58:27,640 --> 00:58:43,240 QUESTION S FOR DIANA? 1210 00:58:43,240 --> 00:58:45,120 >> THAT WAS AN AMAZING 1211 00:58:45,120 --> 00:58:47,680 PRESENTATION AND HUGE AMOUNT OF 1212 00:58:47,680 --> 00:58:47,880 WORK. 1213 00:58:47,880 --> 00:58:51,480 I AM FROM THE CDC FROM THE 1214 00:58:51,480 --> 00:58:52,400 PUBLIC HEALTH PERSPECTIVE THANK 1215 00:58:52,400 --> 00:58:54,800 YOU FOR THE WORK YOU'RE DOING IN 1216 00:58:54,800 --> 00:58:57,720 THE EPIDEMIOLOGY SPACE. 1217 00:58:57,720 --> 00:59:03,480 IT'S CRITICAL AND WANTED TO ASK 1218 00:59:03,480 --> 00:59:11,480 A FOLLOW-UP ABOUT THE ROLE OF 1219 00:59:11,480 --> 00:59:12,480 THE METHAMPHETAMINE STUDY AND 1220 00:59:12,480 --> 00:59:14,280 ONE OF THE STRESSES IS WE DON'T 1221 00:59:14,280 --> 00:59:17,120 HAVE INTERVENTIONS TO DO FOR 1222 00:59:17,120 --> 00:59:19,680 PEOPLE ON METHAMPHETAMINES AND I 1223 00:59:19,680 --> 00:59:23,960 KNOW IT'S OUTSIDE THE ZONE OF 1224 00:59:23,960 --> 00:59:25,240 WHAT WE DO EVERYDAY BUT 1225 00:59:25,240 --> 00:59:27,520 SOMETHING WE TALK ABOUT AT CDC 1226 00:59:27,520 --> 00:59:32,640 AS WHAT WE CAN DO TO PUSH OTHER 1227 00:59:32,640 --> 00:59:34,080 RESEARCH SIMILAR TO WHAT WE KNOW 1228 00:59:34,080 --> 00:59:37,000 ABOUT OPIOIDS. 1229 00:59:37,000 --> 00:59:40,720 IS THERE ANY AWARENESS OF NEXT 1230 00:59:40,720 --> 00:59:43,920 STEPS AND MAYBE NOT OURS BUT 1231 00:59:43,920 --> 00:59:46,680 ONES WE CAN FACILITATE. 1232 00:59:46,680 --> 00:59:48,520 I'M OBSESSED WITH THIS TOPIC 1233 00:59:48,520 --> 00:59:51,240 BECAUSE WHAT DO WE OFFER ON THE 1234 00:59:51,240 --> 00:59:52,200 PUBLIC SIDE OF THE WORLD AND THE 1235 00:59:52,200 --> 00:59:54,240 ANSWER IS NO REALLY GOOD 1236 00:59:54,240 --> 00:59:55,120 INTERVENTION BUT I'D LOVE YOUR 1237 00:59:55,120 --> 00:59:55,360 THOUGHTS. 1238 00:59:55,360 --> 00:59:55,640 THANK YOU. 1239 00:59:55,640 --> 01:00:01,320 >> THANK YOU. 1240 01:00:01,320 --> 01:00:06,440 MOSTLY THANK YOU TOO FOR BEING 1241 01:00:06,440 --> 01:00:07,720 THERE AT THE CDC. 1242 01:00:07,720 --> 01:00:12,480 I ENJOY COLLABORATING WITH YOU. 1243 01:00:12,480 --> 01:00:14,720 THING THERE THING WAS 1244 01:00:14,720 --> 01:00:16,160 DISCOVERING THAT AND SHOWING 1245 01:00:16,160 --> 01:00:18,280 THAT ASSOCIATION. 1246 01:00:18,280 --> 01:00:20,040 THOUGH WE'RE NOT PRIMARILY 1247 01:00:20,040 --> 01:00:23,280 RESPONSIBLE THERE, WE'RE 1248 01:00:23,280 --> 01:00:28,960 PARTNERING REALLY WELL WITH OUR 1249 01:00:28,960 --> 01:00:32,480 COLLEAGUES IN NIDA WHO SEEM TO 1250 01:00:32,480 --> 01:00:37,160 BE REALLY INTERESTED IN THIS 1251 01:00:37,160 --> 01:00:39,520 FINDING. 1252 01:00:39,520 --> 01:00:44,000 I SEE CARL HAS HIS HAND UP. 1253 01:00:44,000 --> 01:00:46,160 >> IN THE DISCUSSION WITH THE 1254 01:00:46,160 --> 01:00:48,840 BUDGET TODAY, ONE OF THE AREAS 1255 01:00:48,840 --> 01:00:51,080 NIDA IS GETTING A BIG INCREASE 1256 01:00:51,080 --> 01:00:53,400 IN IS SPECIFICALLY TO TARGET 1257 01:00:53,400 --> 01:00:53,920 METHAMPHETAMINE USE. 1258 01:00:53,920 --> 01:00:59,480 IT'S RECOGNIZED AS A SIGNIFICANT 1259 01:00:59,480 --> 01:01:07,440 PROBLEM AND NORA AND THE TEAM 1260 01:01:07,440 --> 01:01:08,480 HAVE BEEN TRYING AND WE'LL SEE 1261 01:01:08,480 --> 01:01:10,200 WHAT WE CAN DO. 1262 01:01:10,200 --> 01:01:15,480 >> HAPPY TO OFFER IF YOU NEED A 1263 01:01:15,480 --> 01:01:16,480 PUBLIC VOICE. 1264 01:01:16,480 --> 01:01:19,040 I'M HAPPY TO BE PART OF THAT 1265 01:01:19,040 --> 01:01:19,360 CONVERSATION. 1266 01:01:19,360 --> 01:01:24,120 >> I THINK THEY ARE VERY AWARE. 1267 01:01:24,120 --> 01:01:26,400 WE'VE HAD FOR A VARIETY OF 1268 01:01:26,400 --> 01:01:27,880 REASONS WE'VE HAD MEETINGS WITH 1269 01:01:27,880 --> 01:01:31,800 THEM ABOUT ANTIBODIES THAT WOULD 1270 01:01:31,800 --> 01:01:35,360 BIND AMPHETAMINES AND THEY'RE 1271 01:01:35,360 --> 01:01:37,760 LITERALLY TRYING TO PUSH EVERY 1272 01:01:37,760 --> 01:01:38,520 BUTTON AT THIS POINT. 1273 01:01:38,520 --> 01:01:40,480 WE'LL CONTINUE TO WORK WITH THEM 1274 01:01:40,480 --> 01:01:44,480 AND ALSO GO OLD FASHIONED 1275 01:01:44,480 --> 01:01:49,320 ACTIVITIES THAT CAN REACH INTO 1276 01:01:49,320 --> 01:01:52,440 COMMUNITY AND DO THE KIND OF 1277 01:01:52,440 --> 01:01:54,040 CLINICAL INTERVENTIONS ARE ALL 1278 01:01:54,040 --> 01:01:57,800 WE HAVE RIGHT NOW THIS IS AN 1279 01:01:57,800 --> 01:01:58,800 EXAMPLE OF WHERE STUDIES LIKE 1280 01:01:58,800 --> 01:02:02,800 ARE GOING ON IN THE CITY HERE 1281 01:02:02,800 --> 01:02:04,320 WHERE THERE'S AN INTERVENTION 1282 01:02:04,320 --> 01:02:07,920 CAN YOU FIRST INTERVENE WITH SAY 1283 01:02:07,920 --> 01:02:12,920 PREP AND GET SOMEBODY ON PREP 1284 01:02:12,920 --> 01:02:19,320 AND THEN WORRY ABOUT HAVING THEM 1285 01:02:19,320 --> 01:02:24,880 TRITATE OFF THEIR AMPHETAMINE 1286 01:02:24,880 --> 01:02:26,440 AND THE GATEWAY DRUG LIKE PREP 1287 01:02:26,440 --> 01:02:27,520 IS AN INTERESTING CONCEPT. 1288 01:02:27,520 --> 01:02:48,040 >> THANKS. 1289 01:02:48,040 --> 01:02:49,720 >> COULD THERE BE VIROLOGY 1290 01:02:49,720 --> 01:02:53,480 UNDERLYING THIS BEHAVIOR? 1291 01:02:53,480 --> 01:02:55,960 >> NIDA HAS PROGRAMS IN RECEPTOR 1292 01:02:55,960 --> 01:02:59,520 DENSITIES AND THINGS LIKE THAT. 1293 01:02:59,520 --> 01:03:13,520 >> THANKS. 1294 01:03:13,520 --> 01:03:16,400 >> THAT STUDY LOOKED AT 1295 01:03:16,400 --> 01:03:16,680 BEHAVIOR. 1296 01:03:16,680 --> 01:03:21,320 >> ANY OTHER QUESTIONS? 1297 01:03:21,320 --> 01:03:24,560 >> MONICA HAS HER HAND UP. 1298 01:03:24,560 --> 01:03:27,880 >> THANK YOU FOR GOING OVER THE 1299 01:03:27,880 --> 01:03:29,160 LITE PREP WORK BECAUSE THAT'S 1300 01:03:29,160 --> 01:03:30,720 IMPORTANT AND WONDERING THE LITE 1301 01:03:30,720 --> 01:03:35,280 TREATMENT GRANTS WE TALKED ABOUT 1302 01:03:35,280 --> 01:03:37,720 LAST TIME AT OARAC ARE GOING TO 1303 01:03:37,720 --> 01:03:40,360 BE LAUNCHED SOON BECAUSE THEY'RE 1304 01:03:40,360 --> 01:03:41,480 COMPLEMENTARY AT GETTING AT THE 1305 01:03:41,480 --> 01:03:55,440 LAST 10% NON-VIROLOGICALLY 1306 01:03:55,440 --> 01:03:55,880 SUPPRESSED GROUP. 1307 01:03:55,880 --> 01:03:58,160 >> YES, WE'RE WORKING ON THAT 1308 01:03:58,160 --> 01:04:01,120 AND WILL HOPEFULLY HAVE RESULT 1309 01:04:01,120 --> 01:04:02,120 TO REPORT AT ONE OF THESE NEXT 1310 01:04:02,120 --> 01:04:16,360 MEETINGS. 1311 01:04:16,360 --> 01:04:18,920 >> ANITA. 1312 01:04:18,920 --> 01:04:19,760 >> THANK YOU, WONDERFUL WORK YOU 1313 01:04:19,760 --> 01:04:22,320 AND YOUR TEAM ARE DOING. 1314 01:04:22,320 --> 01:04:23,360 QUESTIONS ABOUT THE IDEA 1315 01:04:23,360 --> 01:04:28,600 CONSORTIUM BECAUSE I THINK IT'S 1316 01:04:28,600 --> 01:04:30,480 A REAL OPPORTUNITY FOR GETTING 1317 01:04:30,480 --> 01:04:36,200 IMPORTANT EPIDEMIOLOGICAL DATA 1318 01:04:36,200 --> 01:04:39,720 AND ADDING ON A BIO SPECIMEN 1319 01:04:39,720 --> 01:04:42,400 COLLECTION WHICH HASN'T BEEN 1320 01:04:42,400 --> 01:04:45,520 TRADITIONALLY THE IDEA APPROACH. 1321 01:04:45,520 --> 01:04:46,760 I KNOW THE SENTINEL SURVEILLANCE 1322 01:04:46,760 --> 01:04:48,840 PROGRAM WILL ADD ON A T.B. 1323 01:04:48,840 --> 01:04:51,560 COMPONENT AND HAS NCB COMPONENT 1324 01:04:51,560 --> 01:04:53,760 FOR ITS WORK BUT I JUST WONDER 1325 01:04:53,760 --> 01:04:56,720 IF THERE'LL BE SCOPE FOR ADDING 1326 01:04:56,720 --> 01:04:58,920 A BIO REPOSITORY ASPECT TO 1327 01:04:58,920 --> 01:05:00,160 REQUIRE SIGNIFICANT RESOURCES 1328 01:05:00,160 --> 01:05:03,800 BUT WOULD GIVE THE OPPORTUNITY 1329 01:05:03,800 --> 01:05:06,120 TO COLLECT IN A WAY WE DON'T 1330 01:05:06,120 --> 01:05:10,720 HAVE ANY OTHER RESOURCE. 1331 01:05:10,720 --> 01:05:13,000 JUST WONDERING THERE'S AN 1332 01:05:13,000 --> 01:05:13,280 APPROACH. 1333 01:05:13,280 --> 01:05:16,880 >> WE'VE TALKED ABOUT IT AND 1334 01:05:16,880 --> 01:05:18,520 IT'S SOMETHING THAT COMES UP. 1335 01:05:18,520 --> 01:05:24,600 OF COURSE, EXACTLY WHAT YOU SAY, 1336 01:05:24,600 --> 01:05:36,000 IT'S EXPENSIVE. 1337 01:05:36,000 --> 01:05:37,600 THE OTHER IS THE QUALITY OF THE 1338 01:05:37,600 --> 01:05:38,880 SPECIMENS YOU KNOW BETTER THAN 1339 01:05:38,880 --> 01:05:39,400 ANYONE. 1340 01:05:39,400 --> 01:05:41,160 A QUESTION OF HOW THAT CAN BE 1341 01:05:41,160 --> 01:05:43,360 DONE IN A COST EFFECTIVE MANNER 1342 01:05:43,360 --> 01:05:49,720 IS A TRICKY QUESTION. 1343 01:05:49,720 --> 01:05:53,520 IF WE HAD LOTS OF MONEY IT WOULD 1344 01:05:53,520 --> 01:05:54,520 BE SOMETHING WE'D CONSIDER BUT 1345 01:05:54,520 --> 01:06:02,440 YOU HIT THE NAIL ON THE HEAD. 1346 01:06:02,440 --> 01:06:05,480 >> MAYBE NOT COLLECTING FOR THE 1347 01:06:05,480 --> 01:06:09,480 SAKE OF COLLECTING BUT IN 1348 01:06:09,480 --> 01:06:10,960 APPROACHES TO TARGET HYPOTHESES 1349 01:06:10,960 --> 01:06:14,320 TO GET ADDED ON TO ANSWER 1350 01:06:14,320 --> 01:06:16,440 BECAUSE I THINK WE KNOW THE 1351 01:06:16,440 --> 01:06:19,400 VALUE OF EPIDEMIOLOGICAL DATA 1352 01:06:19,400 --> 01:06:21,280 BUT THERE'S MORE WHEN THERE'S 1353 01:06:21,280 --> 01:06:23,120 MORE STRATEGICALLY COLLECTED 1354 01:06:23,120 --> 01:06:25,120 SAMPLES TO ADD VALUE. 1355 01:06:25,120 --> 01:06:30,360 >> I COMPLETELY AGREE AND PARTS 1356 01:06:30,360 --> 01:06:32,240 OF THE OBJECTIVE WHERE AT THE 1357 01:06:32,240 --> 01:06:34,200 EXPENSE OF REPOSITORIES AND 1358 01:06:34,200 --> 01:06:34,800 TRUSTING THE QUALITY OF THE 1359 01:06:34,800 --> 01:06:38,400 SAMPLES AND THAT SORT OF THING 1360 01:06:38,400 --> 01:06:42,000 IS TOO EXPENSIVE FOR WHAT YOU'RE 1361 01:06:42,000 --> 01:06:44,280 TALKING ABOUT, YES. 1362 01:06:44,280 --> 01:06:44,880 WE SHOULD HAVE FURTHER 1363 01:06:44,880 --> 01:06:46,840 CONVERSATION THAT. 1364 01:06:46,840 --> 01:06:51,680 >> GREAT, THANKS, DIANA AND 1365 01:06:51,680 --> 01:06:55,520 AMITA FOR THE DISCUSSION. 1366 01:06:55,520 --> 01:06:57,080 LET'S MOVE ON TO THE VACCINE 1367 01:06:57,080 --> 01:07:03,680 RESEARCH PROGRAM AND MARY 1368 01:07:03,680 --> 01:07:03,920 MAROVICH. 1369 01:07:11,120 --> 01:07:16,440 >> THANKS SO MUCH, KEN. 1370 01:07:16,440 --> 01:07:18,080 YOU THE TRICK. 1371 01:07:18,080 --> 01:07:22,520 >> I'M MARY MAROVICH AND GIVING 1372 01:07:22,520 --> 01:07:23,720 THE UPDATE ON THE VACCINE 1373 01:07:23,720 --> 01:07:30,800 RESEARCH PROGRAM TODAY. 1374 01:07:30,800 --> 01:07:35,080 I'LL GO THROUGH A FEW QUICK 1375 01:07:35,080 --> 01:07:37,640 UPDATES FOR THE COVID-19 1376 01:07:37,640 --> 01:07:39,080 RESPONSE AND FOCUS ON THE 1377 01:07:39,080 --> 01:07:40,200 CURRENT VACCINE STRATEGY WHERE 1378 01:07:40,200 --> 01:07:43,080 WE'RE DOING A LOT OF DISCOVERY 1379 01:07:43,080 --> 01:07:46,560 AND DESIGN AND I'LL REVIEW 1380 01:07:46,560 --> 01:07:47,480 CONCEPTS IN EARLY TESTING AND 1381 01:07:47,480 --> 01:07:49,120 SOME THAT WERE TESTED IN ADVANCE 1382 01:07:49,120 --> 01:07:50,560 STUDIES AND LOOK TO THE FUTURE 1383 01:07:50,560 --> 01:07:55,800 FOR DIRECTIONS OF VACCINES. 1384 01:07:55,800 --> 01:07:58,920 SO THE MISSION IS REALLY 1385 01:07:58,920 --> 01:07:59,520 STANFORD FOR THE VACCINE 1386 01:07:59,520 --> 01:08:01,640 RESEARCH PROGRAM. 1387 01:08:01,640 --> 01:08:03,920 IT'S JUST TO DESIGN A SAFE AND 1388 01:08:03,920 --> 01:08:06,480 EFFECTIVE HIV VACCINE TO HELP US 1389 01:08:06,480 --> 01:08:09,480 GET CONTROL OF THE EPIDEMIC AND 1390 01:08:09,480 --> 01:08:11,920 THE WAY WE DO THAT IS WE HAVE 1391 01:08:11,920 --> 01:08:13,720 THREE DIFFERENT BRANCHES YOU CAN 1392 01:08:13,720 --> 01:08:18,160 SEE ON THE BOTTOM OF THE SLIDE 1393 01:08:18,160 --> 01:08:20,400 FROM SOUP TO NUTS THE PRECLINIC 1394 01:08:20,400 --> 01:08:27,520 AND DEVELOPMENT BRANCH ON THE 1395 01:08:27,520 --> 01:08:36,720 LEFT NEXT THE PROMISING VACCINE 1396 01:08:36,720 --> 01:08:39,520 BRANCH MOVING THEM TO CLINIC AND 1397 01:08:39,520 --> 01:08:42,920 THE MOST PROMISING AND 1398 01:08:42,920 --> 01:08:51,480 MANUFACTURABLE AND STABLE IMMUNO 1399 01:08:51,480 --> 01:08:53,400 IMMUNOGENS WOULD BE MOVED TO THE 1400 01:08:53,400 --> 01:08:53,920 VACCINE CLINICAL RESEARCH 1401 01:08:53,920 --> 01:09:02,720 BRANCH. 1402 01:09:02,720 --> 01:09:05,160 WITH WE HAVE TALENTED STAFF WHO 1403 01:09:05,160 --> 01:09:07,880 SUPPORT ALL THESE BRANCHES AND 1404 01:09:07,880 --> 01:09:12,600 WORK TOGETHER AS A MENTIONED TO 1405 01:09:12,600 --> 01:09:14,920 ADDRESS THE HIV EPIDEMIC BY 1406 01:09:14,920 --> 01:09:16,120 PROMOTING RESEARCH PROGRAMS THAT 1407 01:09:16,120 --> 01:09:17,440 DISCOVER NOVEL VACCINE 1408 01:09:17,440 --> 01:09:18,920 CANDIDATES AND NEW STRATEGIES 1409 01:09:18,920 --> 01:09:23,720 AND CREATIVE STRATEGIES AND USE 1410 01:09:23,720 --> 01:09:26,800 THE SUSTAIN COMMITMENT AND 1411 01:09:26,800 --> 01:09:28,520 INVESTMENT FROM NIAID TO SUPPORT 1412 01:09:28,520 --> 01:09:31,320 THE INVESTIGATORS TO MOVE THE 1413 01:09:31,320 --> 01:09:32,520 FIELD FORWARD. 1414 01:09:32,520 --> 01:09:36,480 WE USE BOTH SCIENCE AND DATABASE 1415 01:09:36,480 --> 01:09:39,560 DECISIONS ALONG WITH PEER REVIEW 1416 01:09:39,560 --> 01:09:44,120 AND THEN SOME MILESTONE APPROACH 1417 01:09:44,120 --> 01:09:47,520 FOR RESEARCH PERFORMANCE AND 1418 01:09:47,520 --> 01:09:53,000 PRACTICE. 1419 01:09:53,000 --> 01:09:55,360 THIS IS ALL THE PEOPLE WHO MAKE 1420 01:09:55,360 --> 01:09:58,920 THIS HAPPEN IN CASE I RAN OUT OF 1421 01:09:58,920 --> 01:09:59,320 TIME. 1422 01:09:59,320 --> 01:10:00,920 FIRST TO ACKNOWLEDGE THE 1423 01:10:00,920 --> 01:10:03,440 COMMUNITY PARTNERS AND 1424 01:10:03,440 --> 01:10:04,480 PARTICIPANTS WITHOUT WHICH WE 1425 01:10:04,480 --> 01:10:07,120 COULD NOT MAKE HEADWAY SO THANKS 1426 01:10:07,120 --> 01:10:09,680 TO THEM AND FOR SENIOR 1427 01:10:09,680 --> 01:10:13,040 MANAGEMENT WITHIN NIAID, 1428 01:10:13,040 --> 01:10:16,160 DR. FAUCI AND DR. DIEFFENBACH 1429 01:10:16,160 --> 01:10:19,080 WHO CONTINUE TO SUPPORT THE 1430 01:10:19,080 --> 01:10:21,280 PROGRAM THROUGH THE UPS AND 1431 01:10:21,280 --> 01:10:23,440 DOWNS AND JIM LANE THE DEPUTY 1432 01:10:23,440 --> 01:10:26,840 DIRECTOR OF MY OFFICE WHO HAS 1433 01:10:26,840 --> 01:10:34,640 DONIO 1434 01:10:34,640 --> 01:10:39,240 DONI 1435 01:10:39,240 --> 01:10:51,560 DONE YAOMAN'S WORK AND THE 1436 01:10:51,560 --> 01:10:54,360 BRANCH CHIEF AND OTHERS IN 1437 01:10:54,360 --> 01:11:03,480 PARTICULAR AND ANGELA AND JULIA 1438 01:11:03,480 --> 01:11:09,520 HUTTER, AND THOSE WHO 1439 01:11:09,520 --> 01:11:10,520 CONTRIBUTED TO THIS PRESENTATION 1440 01:11:10,520 --> 01:11:16,280 AND WERE ABLE TO PULL DATA AND 1441 01:11:16,280 --> 01:11:22,600 REVIEW IT AND TAKE ALL 1442 01:11:22,600 --> 01:11:24,120 RESPONSIBILITY IF ANYTHING'S 1443 01:11:24,120 --> 01:11:24,520 UNCLEAR. 1444 01:11:24,520 --> 01:11:27,520 I ALSO WANTED TO RECOGNIZE THE 1445 01:11:27,520 --> 01:11:28,920 PRINCIPLE INVESTIGATOR LAB SITES 1446 01:11:28,920 --> 01:11:33,680 AND USUAL PARTNERS WHO WORK HARD 1447 01:11:33,680 --> 01:11:35,520 TO CONTINUE AND I THINK IT WAS 1448 01:11:35,520 --> 01:11:38,120 KEN WHO MENTIONED NOBODY'S 1449 01:11:38,120 --> 01:11:41,320 REALLY IN THIS FOR THE SHORT 1450 01:11:41,320 --> 01:11:41,720 TERM. 1451 01:11:41,720 --> 01:11:51,520 IT'S SORT OF A LONG-TERM 1452 01:11:51,520 --> 01:11:54,800 COMMITMENT. 1453 01:11:54,800 --> 01:11:56,280 CAROL HAS MENTIONED SOME OF 1454 01:11:56,280 --> 01:11:59,600 THESE THE ADVANCES WITHIN THE 1455 01:11:59,600 --> 01:12:02,520 COVID VACCINE FIELD. 1456 01:12:02,520 --> 01:12:05,520 I WANT TO MAKE A POINT I CANNOT 1457 01:12:05,520 --> 01:12:09,800 OVER EMPHASIZE THE CONTRIBUTION 1458 01:12:09,800 --> 01:12:11,520 THAT THE HIV/AIDS FIELD HAS MADE 1459 01:12:11,520 --> 01:12:12,720 TO THE SUCCESSES WITHIN THE 1460 01:12:12,720 --> 01:12:15,520 COVID PARTICULARLY VACCINE 1461 01:12:15,520 --> 01:12:23,520 WORLD. 1462 01:12:23,520 --> 01:12:24,920 WE KNOW THESE WERE REMARKABLE 1463 01:12:24,920 --> 01:12:27,040 VACCINATIONS TO COME UP WITH A 1464 01:12:27,040 --> 01:12:28,320 VACCINE WITHIN A YEAR AND 1465 01:12:28,320 --> 01:12:30,960 DEPLOYED BUT WE KNOW THERE WERE 1466 01:12:30,960 --> 01:12:32,800 SUCCESSES BORROWED AND 1467 01:12:32,800 --> 01:12:33,720 INVESTIGATORS IN CLINICAL TRIAL 1468 01:12:33,720 --> 01:12:35,720 SITES BORROWED FROM THE HIV 1469 01:12:35,720 --> 01:12:41,440 FIELD AND A CALL OUT OR SHOUT 1470 01:12:41,440 --> 01:12:41,600 OUT. 1471 01:12:41,600 --> 01:12:46,640 WE USED THE mRNA PLATFORM FOR 1472 01:12:46,640 --> 01:12:48,120 EXPEDIENCY AND THOSE ARE THE 1473 01:12:48,120 --> 01:12:50,040 VACCINE CAME OUT FIRST AND 1474 01:12:50,040 --> 01:12:53,440 MODERNA WAS JUST ISSUED ITS 1475 01:12:53,440 --> 01:12:54,280 BIOLOGICAL LICENSE TODAY FROM 1476 01:12:54,280 --> 01:12:56,520 THE FDA, MANY ARE PROBABLY AWARE 1477 01:12:56,520 --> 01:13:00,680 OF THAT, AND NOW BOTH mRNA s ARE 1478 01:13:00,680 --> 01:13:04,240 FULLY LICENSED PRODUCTS. 1479 01:13:04,240 --> 01:13:11,320 THE FACTOR AD VECTOR HAD 1480 01:13:11,320 --> 01:13:13,440 STABILITY AND ALL THE VACCINES 1481 01:13:13,440 --> 01:13:17,520 HAVE DEMONSTRATED REMARKABLE 1482 01:13:17,520 --> 01:13:20,760 EFFICACY AND CLEARLY EXCEED THE 1483 01:13:20,760 --> 01:13:22,640 NON-INFERIORITY MARGINS GREATER 1484 01:13:22,640 --> 01:13:29,560 THAN 50% ACCURACY AND ALL THESE 1485 01:13:29,560 --> 01:13:38,120 HAVE MET THAT MARK WITH THE 1486 01:13:38,120 --> 01:13:40,800 EXCEPTION OF SANOFI WHICH WE 1487 01:13:40,800 --> 01:13:42,840 EXPECT TO HAVE SOON. 1488 01:13:42,840 --> 01:13:44,800 THE INTERESTING FEATURE IS THERE 1489 01:13:44,800 --> 01:13:48,520 WAS A NICE SUMMARY ON THE 1490 01:13:48,520 --> 01:13:51,040 STRUCTURE OF ENVELOPE SPIKES AND 1491 01:13:51,040 --> 01:13:53,520 PRE FUSION AND STABILIZATION, 1492 01:13:53,520 --> 01:13:56,600 ETCETERA AND CREDIT TO THE VRC 1493 01:13:56,600 --> 01:13:58,160 BECAUSE ALL YOU'LL SEE IN THE 1494 01:13:58,160 --> 01:14:00,280 WHOLE SCREEN OF VACCINES, FIVE 1495 01:14:00,280 --> 01:14:11,560 OF THE SIX USE THE STABILIZED 1496 01:14:11,560 --> 01:14:14,560 S2P THE ONLY VACCINE THAT DID 1497 01:14:14,560 --> 01:14:19,840 NOT USE THAT STABILIZED SPIKE 1498 01:14:19,840 --> 01:14:26,680 WAS THE GEN OX THEY USED THE 1499 01:14:26,680 --> 01:14:30,160 WILD TYPE AND ANYONE WHO WORKS 1500 01:14:30,160 --> 01:14:33,200 IN THE VACCINE FIELD KNOW WE TRY 1501 01:14:33,200 --> 01:14:37,720 TO DEVELOP TRIMERIC ENZYMES AND 1502 01:14:37,720 --> 01:14:39,520 THAT'S TRUE BECAUSE THE NOVA VAX 1503 01:14:39,520 --> 01:14:41,120 AND SANOFI PRODUCTS WERE THE 1504 01:14:41,120 --> 01:14:43,800 MOST DIFFICULT TO MAKE AND THOSE 1505 01:14:43,800 --> 01:14:45,800 ARE IN THE LATER STAGES OF 1506 01:14:45,800 --> 01:14:49,640 STUDYING AND APPROVAL THOUGH 1507 01:14:49,640 --> 01:14:51,080 NOVAVAX WILL BE SUBMITTING THEIR 1508 01:14:51,080 --> 01:14:52,800 UEA SHORTLY IF THEY HAVEN'T 1509 01:14:52,800 --> 01:14:54,920 ALREADY AND DEMONSTRATED 1510 01:14:54,920 --> 01:14:55,160 EFFICACY. 1511 01:14:55,160 --> 01:14:57,520 THANKS TO ALL THE NETWORK FOLKS 1512 01:14:57,520 --> 01:14:58,840 AND ALL THE NIH AND OTHERS WHO 1513 01:14:58,840 --> 01:15:00,640 HAVE WORKED ON THESE STUDIES TO 1514 01:15:00,640 --> 01:15:15,560 THEIR GREAT SUCCESS. 1515 01:15:15,560 --> 01:15:16,600 MULTIPLE STUDIES WERE INVOLVED 1516 01:15:16,600 --> 01:15:22,240 AND FROM THE PREVENTION 1517 01:15:22,240 --> 01:15:24,520 STANDPOINT THE LILLY 1518 01:15:24,520 --> 01:15:28,680 CONVERSATION WAS STUDIED AND 1519 01:15:28,680 --> 01:15:31,320 DEMONSTRATED GOOD EFFICACY AND 1520 01:15:31,320 --> 01:15:34,720 REGENERON STUDY WAS A HOUSEHOLD 1521 01:15:34,720 --> 01:15:39,480 STUDY AND THIS WAS CLASSIC HIV 1522 01:15:39,480 --> 01:15:46,000 AND SAME WITH ASTRAZENECA THE 1523 01:15:46,000 --> 01:15:53,080 ONE IN COMBINATION WITH PREB AND 1524 01:15:53,080 --> 01:15:54,520 VIR CAN HANDLE THE ISSUE FOR 1525 01:15:54,520 --> 01:15:55,600 TREATMENT AND BEING FROM THE HIV 1526 01:15:55,600 --> 01:15:59,320 VACCINE FIELD I THINK WE HAVE 1527 01:15:59,320 --> 01:16:02,480 SOME CAUTION TO FIGURE ABOUT 1528 01:16:02,480 --> 01:16:04,480 USING A MONOCLONAL ANTIBODY IN 1529 01:16:04,480 --> 01:16:06,160 THAT SETTING AND PROTECTING THE 1530 01:16:06,160 --> 01:16:10,320 USE OF THAT ANTIBODY AND CURRENT 1531 01:16:10,320 --> 01:16:10,920 SHORT SUPPLY. 1532 01:16:10,920 --> 01:16:12,920 WE HAVE A LOT OF WORK TO DO 1533 01:16:12,920 --> 01:16:14,200 THERE AND AGAIN I'LL THANK ALL 1534 01:16:14,200 --> 01:16:15,560 THE NETWORKS FOR THEIR 1535 01:16:15,560 --> 01:16:18,280 CONTRIBUTION. 1536 01:16:18,280 --> 01:16:24,120 SO AS I MENTIONED, THE SUCCESS 1537 01:16:24,120 --> 01:16:27,120 OF THE COVID-19 VACCINES WERE 1538 01:16:27,120 --> 01:16:31,080 REALLY A MEDICAL TRIUMPH. 1539 01:16:31,080 --> 01:16:32,200 AND A LOT OF HIV INVESTIGATORS 1540 01:16:32,200 --> 01:16:33,240 CONTRIBUTED TO THAT. 1541 01:16:33,240 --> 01:16:36,600 SO WE HELD A WORKSHOP AT THE END 1542 01:16:36,600 --> 01:16:37,600 OF OCTOBER. 1543 01:16:37,600 --> 01:16:39,600 WE'RE WANTING TO LOOK BACK OFTEN 1544 01:16:39,600 --> 01:16:43,200 THE LESSONS LEARNED ARE WE 1545 01:16:43,200 --> 01:16:46,280 LEVERAGED THE HIV VACCINE 1546 01:16:46,280 --> 01:16:47,160 ENTERPRISE TO CONTRIBUTE TO THE 1547 01:16:47,160 --> 01:16:48,120 COVID VACCINE DEVELOPMENT AND 1548 01:16:48,120 --> 01:16:50,840 WHAT CAN WE MOVE FORWARD WITH. 1549 01:16:50,840 --> 01:16:53,560 YOU'LL REMEMBER IT WAS A 1550 01:16:53,560 --> 01:16:56,360 U.S. GOVERNMENT INTERAGENCY 1551 01:16:56,360 --> 01:16:56,920 COLLABORATION WITH PUBLIC 1552 01:16:56,920 --> 01:16:58,320 PRIVATE PARTNERSHIPS AND SOME 1553 01:16:58,320 --> 01:16:59,280 THING THE VACCINE CONTRIBUTED 1554 01:16:59,280 --> 01:17:01,480 WAS THAT WE KNEW WE HAD TO BUILD 1555 01:17:01,480 --> 01:17:03,200 TRUST AND TRANSPARENCY FROM 1556 01:17:03,200 --> 01:17:06,280 WORKING ALL OF OUR EXPERIENCE IN 1557 01:17:06,280 --> 01:17:08,360 WORKING WITH COMMUNITIES HEAVILY 1558 01:17:08,360 --> 01:17:10,760 IMPACTED AND THOSE HARD TO REACH 1559 01:17:10,760 --> 01:17:15,520 AND KNEW THE POWER OF INCLUSION 1560 01:17:15,520 --> 01:17:16,920 AND EMPHASIZED THAT AND BEING 1561 01:17:16,920 --> 01:17:18,760 COGNIZANT INCLUSION CREATES 1562 01:17:18,760 --> 01:17:19,560 DIVERSITY OF THOUGHT AND 1563 01:17:19,560 --> 01:17:22,280 INCREASE PARTNERSHIPS AND LEVELS 1564 01:17:22,280 --> 01:17:25,880 THE PLAYING FIELD IN TERMS OF 1565 01:17:25,880 --> 01:17:27,560 POWER SHARING AND INFORMS 1566 01:17:27,560 --> 01:17:30,280 DECISION MAKING WAS A MAJOR 1567 01:17:30,280 --> 01:17:30,800 CONTRIBUTION THAT WASN'T 1568 01:17:30,800 --> 01:17:33,400 HARDCORE STRUCTURAL SCIENCE BUT 1569 01:17:33,400 --> 01:17:34,960 A CONTRIBUTION FROM THE HIV 1570 01:17:34,960 --> 01:17:36,720 FIELD AND THE SPILL OVER EFFECT 1571 01:17:36,720 --> 01:17:39,520 WITH THE INVESTMENT IN BASIC 1572 01:17:39,520 --> 01:17:41,240 SCIENCE STRUCTURE AND VACCINE 1573 01:17:41,240 --> 01:17:45,200 DESIGN AND VALIDATE NEW ASSAYS 1574 01:17:45,200 --> 01:17:52,000 AND ONE WAS ADAPTED FOR SARS 2 1575 01:17:52,000 --> 01:17:54,520 AND USED FOR STUDIES AND WE KNOW 1576 01:17:54,520 --> 01:17:56,520 DATA SHARING AND TRANSPARENCY IS 1577 01:17:56,520 --> 01:18:01,120 CRITICAL BECAUSE THE CONSEQUENCE 1578 01:18:01,120 --> 01:18:02,920 WAS PROVIDED THEN ALL THE 1579 01:18:02,920 --> 01:18:04,280 VACATIONS COULD BE DEVELOPED AND 1580 01:18:04,280 --> 01:18:06,080 THE LAST THING TO DRAW THE 1581 01:18:06,080 --> 01:18:07,480 PARALLEL IS THE IDENTIFICATION 1582 01:18:07,480 --> 01:18:16,720 OF CORRELATES OF PROTECTION WE 1583 01:18:16,720 --> 01:18:20,360 NOW HAVE A SUITE OF VACCINES AND 1584 01:18:20,360 --> 01:18:23,240 HAVING PROTECTION ALLOWS VACCINE 1585 01:18:23,240 --> 01:18:24,760 DEVELOPMENT WITHOUT HAVING TO DO 1586 01:18:24,760 --> 01:18:27,200 LARGE SCALE PHASE 3 EFFICACY 1587 01:18:27,200 --> 01:18:28,240 TRIALS AND COULDN'T DO PLACEBO 1588 01:18:28,240 --> 01:18:34,480 CONTROLLED TRIALS AT THIS POINT. 1589 01:18:34,480 --> 01:18:36,880 IT'S TIME CONSUMING AND WE NEED 1590 01:18:36,880 --> 01:18:39,520 TO BE ABLE TO MOVE QUICKER AND 1591 01:18:39,520 --> 01:18:41,520 WHERE HIV DEVELOPMENT IS BUMPING 1592 01:18:41,520 --> 01:18:45,120 UP AGAINST, WE NOW HAVE POWERFUL 1593 01:18:45,120 --> 01:18:46,680 PREVENTION METHODS THAT DOING 1594 01:18:46,680 --> 01:18:48,920 OUR LARGE-SCALE HIV VACCINE 1595 01:18:48,920 --> 01:18:49,960 TRAILS NEED TO BE RECONSIDERED 1596 01:18:49,960 --> 01:18:52,760 IN HOW TO ADDRESS THAT AND IF WE 1597 01:18:52,760 --> 01:18:53,800 CAN HAVE CORRELATES THAT CAN 1598 01:18:53,800 --> 01:18:54,320 HELP INFORM. 1599 01:18:54,320 --> 01:18:56,320 I WANTED TO BRING YOU TO THAT 1600 01:18:56,320 --> 01:19:00,880 AND JUST LET YOU KNOW THAT THAT 1601 01:19:00,880 --> 01:19:06,240 WAS A GREAT WORKSHOP AND 1602 01:19:06,240 --> 01:19:15,160 SUPPORTED BY BOTH SIDES. 1603 01:19:15,160 --> 01:19:17,120 THE TOP HALF IS THE EMPIRICAL 1604 01:19:17,120 --> 01:19:17,520 APPROACH. 1605 01:19:17,520 --> 01:19:20,560 THE TWO-PRONGED APPROACH FOR 1606 01:19:20,560 --> 01:19:23,200 VACCINE STRATEGIES AND YOU'LL 1607 01:19:23,200 --> 01:19:24,680 REMEMBER THAT'S THE RV144 TRYING 1608 01:19:24,680 --> 01:19:28,680 TO BUILD AND REPRODUCE OFF THE 1609 01:19:28,680 --> 01:19:35,280 FINDING OF VE OF 31% AND THE 1610 01:19:35,280 --> 01:19:42,480 IDEA WAS TO MOVE TO AREAS THAT 1611 01:19:42,480 --> 01:19:44,120 WERE HARD HIT LIKE SOUTH AFRICA 1612 01:19:44,120 --> 01:19:46,120 AND THERE WAS A PROTEIN BOOST 1613 01:19:46,120 --> 01:19:48,240 AND UNFORTUNATELY A STUDY WAS 1614 01:19:48,240 --> 01:19:50,560 STOPPED FOR EFFICACY TWO YEARS 1615 01:19:50,560 --> 01:19:51,960 AGO. 1616 01:19:51,960 --> 01:19:55,680 AND SUBSEQUENT WE HAD THE 1617 01:19:55,680 --> 01:19:58,520 COLLABORATION USING THE AD 1618 01:19:58,520 --> 01:20:02,520 VECTOR BOOSTED WITH AN ENVELOPE 1619 01:20:02,520 --> 01:20:05,480 A 705 STUDY IN ADVERSE WOMEN IN 1620 01:20:05,480 --> 01:20:06,760 SOUTH AFRICA IN ADDITION THAT 1621 01:20:06,760 --> 01:20:09,120 WAS STOPPED FOR NON-EFFICACY 1622 01:20:09,120 --> 01:20:13,320 LAST YEAR. 1623 01:20:13,320 --> 01:20:18,480 AND CARL MENTIONED WE HAVE A 1624 01:20:18,480 --> 01:20:20,600 SISTER STUDY 706 CONTINUING WITH 1625 01:20:20,600 --> 01:20:23,280 THE MOSAIC BECAUSE IT HAS AN 1626 01:20:23,280 --> 01:20:26,280 ADDITIONAL BOOST. 1627 01:20:26,280 --> 01:20:31,520 IT HAS THE ADENOVIRUS AND THEN 1628 01:20:31,520 --> 01:20:38,320 GP140 MOSAIC BOOST SO THAT STUDY 1629 01:20:38,320 --> 01:20:41,160 IS BEING MONITORED AND KEEP YOU 1630 01:20:41,160 --> 01:20:42,720 UPDATED HOW IT'S PROGRESSING BUT 1631 01:20:42,720 --> 01:20:44,560 FOR TODAY I THOUGHT WE SHOULD 1632 01:20:44,560 --> 01:20:45,880 FOCUS ON THE THEORETICAL 1633 01:20:45,880 --> 01:20:48,160 APPROACH AND THE BROADLY 1634 01:20:48,160 --> 01:20:49,280 NEUTRALIZING ANTIBODY EFFORTS 1635 01:20:49,280 --> 01:20:54,440 ONGOING WHICH ARE REMARKABLE. 1636 01:20:54,440 --> 01:20:56,960 THE IDEA IS WE WOULD DEVELOP 1637 01:20:56,960 --> 01:21:00,680 VACCINES THAT COULD INDUCE 1638 01:21:00,680 --> 01:21:03,800 NEUTRALIZING ANTIBODIES AND USE 1639 01:21:03,800 --> 01:21:06,080 BROADLY NEUTRALIZING ANTIBODIES 1640 01:21:06,080 --> 01:21:12,240 IN A CONCEPT TO SEE IF IN FACT 1641 01:21:12,240 --> 01:21:13,640 NEUTRALIZING ANTIBODIES COULD BE 1642 01:21:13,640 --> 01:21:15,320 PART OF THE AMP STUDY AND THE 1643 01:21:15,320 --> 01:21:16,760 RESULTS CAME OUT LAST YEAR I'LL 1644 01:21:16,760 --> 01:21:18,720 REVIEW IN A SECOND. 1645 01:21:18,720 --> 01:21:20,160 IDEALLY, WE'D LIKE TO RECRUIT 1646 01:21:20,160 --> 01:21:23,520 ALL THE IMMUNOLOGIC DEFENSES AND 1647 01:21:23,520 --> 01:21:26,040 ADAPTIVE HUMORAL AND CELLULAR 1648 01:21:26,040 --> 01:21:28,120 AND TODAY I'LL FOCUS ON THE 1649 01:21:28,120 --> 01:21:29,720 ELICITATION OF BROADLY 1650 01:21:29,720 --> 01:21:37,240 NEUTRALIZING ANTIBODIES FOR 1651 01:21:37,240 --> 01:21:53,280 SIMPLICITY. 1652 01:21:53,280 --> 01:21:56,120 LET'S TALK ABOUT HOW WE'LL 1653 01:21:56,120 --> 01:21:57,960 NEUTRALIZE THESE FOR VACCINE. 1654 01:21:57,960 --> 01:22:00,680 YOU SEE THE SPIKES, ETCETERA. 1655 01:22:00,680 --> 01:22:02,800 WHAT'S IMPORTANT FOR VACCINE 1656 01:22:02,800 --> 01:22:03,520 DEVELOPMENT AS YOU KNOW YOU HAVE 1657 01:22:03,520 --> 01:22:05,320 TO HAVE VACCINE TARGETS. 1658 01:22:05,320 --> 01:22:09,360 WE HAVE MULTIPLE VACCINE TARGETS 1659 01:22:09,360 --> 01:22:12,920 SUSCEPTIBLE TO NEUTRALIZATION. 1660 01:22:12,920 --> 01:22:13,800 THERE'S MANY EXPERTS LEADING 1661 01:22:13,800 --> 01:22:18,920 THIS FIELD SO WE KNOW HOW TO DO 1662 01:22:18,920 --> 01:22:19,120 THAT. 1663 01:22:19,120 --> 01:22:21,120 WE HAVE HIGHER FIDELITY IN 1664 01:22:21,120 --> 01:22:24,600 ANIMAL MODEL AND PLATFORMS TO 1665 01:22:24,600 --> 01:22:28,040 ACCELERATE AND WE KNOW mRNA IS 1666 01:22:28,040 --> 01:22:30,160 FASTER THAN TRIMERIC PROTEINS 1667 01:22:30,160 --> 01:22:33,600 AND HAVE NEAT DATA BEING 1668 01:22:33,600 --> 01:22:35,280 CREATIVE AS FAR AS IMMUNIZATION 1669 01:22:35,280 --> 01:22:37,800 STRATEGIES AND INTERVALS AND 1670 01:22:37,800 --> 01:22:40,520 USING NANO PARTICLES. 1671 01:22:40,520 --> 01:22:42,120 THOSE ARE ALL THE KEY 1672 01:22:42,120 --> 01:22:44,920 INGREDIENTS WE THINK ARE NEED. 1673 01:22:44,920 --> 01:22:49,200 WE SEE THE IMMUNOGEN DESIGN AND 1674 01:22:49,200 --> 01:22:51,320 YOU TAKE THE SPIKES AND DESIGN 1675 01:22:51,320 --> 01:22:54,480 YOUR HIV ENVELOPE TRIMER AND 1676 01:22:54,480 --> 01:22:56,040 THEN PRIME THE IMMUNE SYSTEM 1677 01:22:56,040 --> 01:23:00,400 WITH THAT IMMUNOGEN AND AN 1678 01:23:00,400 --> 01:23:03,720 EXAMPLE WOULD BE THE ENGINEERED 1679 01:23:03,720 --> 01:23:09,040 GTA WHICH WAS DESIGNED BY 1680 01:23:09,040 --> 01:23:13,120 COLLEAGUES AT THE SCRIPPS AND 1681 01:23:13,120 --> 01:23:14,840 THAT STUDY I'LL REVIEW BECAUSE 1682 01:23:14,840 --> 01:23:17,120 THEY'VE DEMONSTRATED THEY CAN DO 1683 01:23:17,120 --> 01:23:18,520 GERM-LINE TARGETING. 1684 01:23:18,520 --> 01:23:20,640 THEY CAN STIMULATE THE B CELLS. 1685 01:23:20,640 --> 01:23:22,520 WE HIT THE NEXT SLIDE IT WILL 1686 01:23:22,520 --> 01:23:27,720 SHOW THE PRECURSOR. 1687 01:23:27,720 --> 01:23:30,320 SO THE IDEA IS YOU PROVIDE THIS 1688 01:23:30,320 --> 01:23:31,600 TO THE CELLS AND WOULD WANT TO 1689 01:23:31,600 --> 01:23:35,520 TRIGGER AS BROADLY AS YOU COULD 1690 01:23:35,520 --> 01:23:37,400 THESE PRECURSOR CELLS AND THEN 1691 01:23:37,400 --> 01:23:38,080 MOVING TOWARDS THE CENTER THERE 1692 01:23:38,080 --> 01:23:41,960 YOU WOULD HAVE TO TAKE THEM TO 1693 01:23:41,960 --> 01:23:44,000 BOOT CAMP THE IDEA OF BRINGING 1694 01:23:44,000 --> 01:23:47,200 THEM TO THE GYM AND WOULD HAVE 1695 01:23:47,200 --> 01:23:50,040 TO STAY WITHIN THE GERMAL CENTER 1696 01:23:50,040 --> 01:23:54,440 AND UNDER GO ROUNDS OF AFFINITY 1697 01:23:54,440 --> 01:23:55,320 MATURATION WHICH WE NOW 1698 01:23:55,320 --> 01:23:56,920 UNDERSTAND HOW WE AFFECT THAT 1699 01:23:56,920 --> 01:24:02,680 AND STILL NEED TO UNDER GO 1700 01:24:02,680 --> 01:24:06,040 MUTATION AND THROUGH BOOSTING 1701 01:24:06,040 --> 01:24:07,520 WE'RE GROWING IN CONFIDENCE WE 1702 01:24:07,520 --> 01:24:11,560 CAN END UP WITH MATURE B CELLS 1703 01:24:11,560 --> 01:24:13,080 TO PRODUCE BROADLY NEUTRALIZING 1704 01:24:13,080 --> 01:24:22,120 ANTIBODIES. 1705 01:24:22,120 --> 01:24:26,360 SO THIS IS A BIG ADVANCE IN THE 1706 01:24:26,360 --> 01:24:34,600 AANIMAL -- ANIMAL MODEL WHERE 1707 01:24:34,600 --> 01:24:35,920 THEY TAKE ADVANTAGE OF THE 1708 01:24:35,920 --> 01:24:43,520 CRISPR TECHNOLOGY AND ABLE TO 1709 01:24:43,520 --> 01:24:48,520 CUSTOMIZE HUMANIZED B CELL 1710 01:24:48,520 --> 01:24:49,920 RECEPTOR EXPRESSING THE 1711 01:24:49,920 --> 01:24:50,360 PRECURSORS. 1712 01:24:50,360 --> 01:24:55,080 THEY CAN DO THIS WITHIN WEEKS 1713 01:24:55,080 --> 01:24:57,040 AND HAVE MICE WITH FUNCTIONAL B 1714 01:24:57,040 --> 01:24:59,520 CELL RECEPTOR AND TEST 1715 01:24:59,520 --> 01:25:03,600 IMMUNOGENS AND THIS CAN HELP US 1716 01:25:03,600 --> 01:25:05,840 RAPIDLY AND ITERATIVELY OPTIMIZE 1717 01:25:05,840 --> 01:25:08,280 THE VACCINES BECAUSE WE CAN TEST 1718 01:25:08,280 --> 01:25:09,520 THEM IN THE MICE DEVELOPED 1719 01:25:09,520 --> 01:25:12,040 QUICKLY AND THEN CAN GO BACK AND 1720 01:25:12,040 --> 01:25:14,440 MODIFY THE IMMUNOGEN AND PUT IT 1721 01:25:14,440 --> 01:25:16,120 BACK IN MICE. 1722 01:25:16,120 --> 01:25:22,560 THIS WAS A HUGE ADVANCE TO -- 1723 01:25:22,560 --> 01:25:24,280 THESE TYPES OF THINGS WERE 1724 01:25:24,280 --> 01:25:25,080 TAKING YEARS TO DEVELOP. 1725 01:25:25,080 --> 01:25:28,360 TO DO THAT IN A ONE-STOP THING 1726 01:25:28,360 --> 01:25:41,280 OVER WEEKS IS FANTASTIC. 1727 01:25:41,280 --> 01:25:47,840 HERE'S THE PRIMATE MODEL HOW THE 1728 01:25:47,840 --> 01:25:53,520 HIV AND SHIV BOTH CO-EVOLVE 1729 01:25:53,520 --> 01:25:54,680 WITHIN PRIMATES OR HUMANS AND 1730 01:25:54,680 --> 01:25:57,360 THE ONLY TWO SYSTEMS WHERE 1731 01:25:57,360 --> 01:26:02,680 BROADLY NEUTRALIZING ANTIBODIES 1732 01:26:02,680 --> 01:26:04,400 AND WE KNOW THE BODY CAN THEY 1733 01:26:04,400 --> 01:26:07,160 CAN THEM AND WE SEE NON-HUMAN 1734 01:26:07,160 --> 01:26:08,680 PRIMATES DO AND WHAT'S 1735 01:26:08,680 --> 01:26:11,560 INTERESTING IS WHEN THERE'S THIS 1736 01:26:11,560 --> 01:26:13,480 ANTIBODY ENVELOPE CO-EVOLUTION 1737 01:26:13,480 --> 01:26:20,880 THAT HAPPENS THAT CAN INFORM THE 1738 01:26:20,880 --> 01:26:25,560 IMMEDIATE IMMUNOGEN TO DRIVE 1739 01:26:25,560 --> 01:26:29,720 THEM TO SUPPORT THE BROADLY 1740 01:26:29,720 --> 01:26:32,360 NEUTRALIZING ANTIBODIES. 1741 01:26:32,360 --> 01:26:36,360 THIS NON-HUMAN PRIMATE MODEL IS 1742 01:26:36,360 --> 01:26:39,080 TO GUIDE THE PRECURSOR B CELLS 1743 01:26:39,080 --> 01:26:42,760 THROUGH MATURATION AND THIS 1744 01:26:42,760 --> 01:26:44,200 MODEL AS WELL CAN HELP INFORM 1745 01:26:44,200 --> 01:26:45,320 VACCINE DESIGN. 1746 01:26:45,320 --> 01:26:50,440 IT'S BEEN USED TO GUIDE V3s AND 1747 01:26:50,440 --> 01:26:53,560 VARIOUS TYPES OF BROADLY 1748 01:26:53,560 --> 01:26:54,680 NEUTRALIZING ANTIBODIES. 1749 01:26:54,680 --> 01:26:55,640 THIS IS INTEREST THE CHURCHILL 1750 01:26:55,640 --> 01:27:06,160 LAB. 1751 01:27:06,160 --> 01:27:13,480 THE G001 STUDY IS THE ENGINEERED 1752 01:27:13,480 --> 01:27:17,120 GERM LINE TARGETING A NANO 1753 01:27:17,120 --> 01:27:19,920 PARTICLE AND HAS A STRONG 1754 01:27:19,920 --> 01:27:22,440 ADJUVANT AND THIS WAS THE FIRST 1755 01:27:22,440 --> 01:27:25,720 IN HUMAN STUDY TRY AND PRIME 1756 01:27:25,720 --> 01:27:27,440 DIVERSE BROADLY NEUTRALIZING 1757 01:27:27,440 --> 01:27:33,920 ANTIBODIES PRECURSORS. 1758 01:27:33,920 --> 01:27:35,240 THE STUDY STARTED SEVERAL YEARS 1759 01:27:35,240 --> 01:27:43,200 AGO AND THE RESULTS WERE 1760 01:27:43,200 --> 01:27:43,840 PROMISING. 1761 01:27:43,840 --> 01:27:50,480 BASICALLY SO THE THEY PROVIDED 1762 01:27:50,480 --> 01:27:54,000 THIS TWO DIFFERENT DOSES TO 48 1763 01:27:54,000 --> 01:27:55,440 PARTICIPANTS AND FOUND IT WAS 1764 01:27:55,440 --> 01:27:59,120 WELL TOLERATED AND FOUND IN 97% 1765 01:27:59,120 --> 01:28:02,520 OF THE PARTICIPANTS THEY 1766 01:28:02,520 --> 01:28:05,600 DEVELOPED THE POSITIVE B CELLS 1767 01:28:05,600 --> 01:28:08,520 AT A HIGH ENOUGH FREQUENCY THEY 1768 01:28:08,520 --> 01:28:14,440 COULD CONSIDER BOOSTING THOSE 1769 01:28:14,440 --> 01:28:16,560 WITH THE RIGHT BOOST. 1770 01:28:16,560 --> 01:28:25,920 THIS IS WHERE OUR ANIMALHOLDSS -- 1771 01:28:25,920 --> 01:28:33,760 ANIMAL MODELS WE LOOKED AT OVER 1772 01:28:33,760 --> 01:28:35,920 TIME OR 16 WEEKS WHERE THEY 1773 01:28:35,920 --> 01:28:40,360 CHECKED AND ON WEEK 4 THE KD IS 1774 01:28:40,360 --> 01:28:44,440 80 AND AS YOU MOVE DOWN TO WEEK 1775 01:28:44,440 --> 01:28:49,440 NINE IT'S 14 AND DOWN TO 4.5. 1776 01:28:49,440 --> 01:28:55,480 THE VACCINE, THIS HAS INDUCED 1777 01:28:55,480 --> 01:29:00,920 THIS MONOCLONAL ANTIBODIES 1778 01:29:00,920 --> 01:29:03,440 CONTINUING TO BIND WITH AFFINITY 1779 01:29:03,440 --> 01:29:05,200 AND THIS IS THE ANIMAL MODEL 1780 01:29:05,200 --> 01:29:09,760 COMING THROUGH IN HUMANS. 1781 01:29:09,760 --> 01:29:11,320 SO HOW ELSE? 1782 01:29:11,320 --> 01:29:12,760 I TALKED ABOUT THE OTHER 1783 01:29:12,760 --> 01:29:15,280 INGREDIENTS TWEAKING THE 1784 01:29:15,280 --> 01:29:15,560 ADJUVANT. 1785 01:29:15,560 --> 01:29:19,040 THERE'S AN INTERESTING ADJUVANT 1786 01:29:19,040 --> 01:29:23,560 COMING OUT OF THE IRVINE 1787 01:29:23,560 --> 01:29:27,560 LABORATORY A SELF ASSEMBLY WITH 1788 01:29:27,560 --> 01:29:32,200 THE AGONIST NPLA AND DOES 1789 01:29:32,200 --> 01:29:36,520 SELF-ASSEMBLE INTO NANO 1790 01:29:36,520 --> 01:29:37,160 PARTICLES. 1791 01:29:37,160 --> 01:29:39,240 IT'S LIKE WHAT'S BEING USED IN 1792 01:29:39,240 --> 01:29:42,520 THE NOVAVAX VACCINE. 1793 01:29:42,520 --> 01:29:44,840 IT'S ALMOST LIKE A CAGE YOU CAN 1794 01:29:44,840 --> 01:29:49,120 SEE AT THE TOP OF THE SLIDE. 1795 01:29:49,120 --> 01:29:53,440 THIS ADJUVANT IS SUPERIOR 1796 01:29:53,440 --> 01:29:57,240 ANTIBODIES AND NON-GERMAL 1797 01:29:57,240 --> 01:29:59,520 RESPONSES AND MECHANISTICALLY 1798 01:29:59,520 --> 01:30:02,120 THE INVESTIGATORS HAVE SHOWN 1799 01:30:02,120 --> 01:30:08,080 THAT THE SNP ADJUVANT HAS A MASS 1800 01:30:08,080 --> 01:30:09,960 CELL DEPENDENT MANNER AND 1801 01:30:09,960 --> 01:30:11,680 INCREASES ANTIGEN DELIVERY. 1802 01:30:11,680 --> 01:30:12,960 THIS IS IN MANUFACTURING AND IF 1803 01:30:12,960 --> 01:30:17,640 WE GO TO THE NEXT SLIDE I'D LIKE 1804 01:30:17,640 --> 01:30:20,200 TO SHOW YOU SOME DATA USING THE 1805 01:30:20,200 --> 01:30:22,760 ADJUVANT IN NON-HUMAN PRIMATE 1806 01:30:22,760 --> 01:30:29,280 AND ANOTHER BUSY SLIDE. 1807 01:30:29,280 --> 01:30:32,120 USING THIS WITH AN ENVELOPE 1808 01:30:32,120 --> 01:30:41,160 PRIMER AND IN COLLABORATION WITH 1809 01:30:41,160 --> 01:30:44,120 OTHERS THEY DEVELOPED THIS 1810 01:30:44,120 --> 01:30:45,720 PRIMING IMMUNIZATION EVERY OTHER 1811 01:30:45,720 --> 01:30:49,720 DAY THEY DOSED THE ANIMALS. 1812 01:30:49,720 --> 01:30:52,880 IN THAT LONG PRIMING PERIOD IT 1813 01:30:52,880 --> 01:30:57,640 LED TO LONG- LIVED GERMINAL 1814 01:30:57,640 --> 01:30:58,560 CENTERS FOR MONTHS AND THAT'S 1815 01:30:58,560 --> 01:31:01,280 THE ENGINE FOR ANTIBODY 1816 01:31:01,280 --> 01:31:03,480 RESPONSES AND TO KEEP THAT 1817 01:31:03,480 --> 01:31:05,920 ACTIVITY ONGOING IN THE 1818 01:31:05,920 --> 01:31:09,560 PROLIFERATION AND THE AFFINITY 1819 01:31:09,560 --> 01:31:15,520 MATURATION IMPROVED THE MAG 1820 01:31:15,520 --> 01:31:18,920 MAGNITUDE AND COMPARING TWO 1821 01:31:18,920 --> 01:31:19,160 GROUPS. 1822 01:31:19,160 --> 01:31:20,640 GROUP GOT THE SEQUENTIAL 1823 01:31:20,640 --> 01:31:22,200 IMMUNIZATION OVER 12 DAYS AND A 1824 01:31:22,200 --> 01:31:25,360 BOOST AT 10 WEEKS VERSUS GROUP 3 1825 01:31:25,360 --> 01:31:27,520 WHO HAD A SIMILAR SLOW 12 DAY 1826 01:31:27,520 --> 01:31:29,040 IMMUNIZATION AND WERE BOOSTED 1827 01:31:29,040 --> 01:31:32,000 OUT HERE AT WEEK 30 THEN THEY 1828 01:31:32,000 --> 01:31:34,840 LOOKED AT THE GERMAL CENTERS AND 1829 01:31:34,840 --> 01:31:36,520 ANTIBODIES DEVELOPED AND THE 1830 01:31:36,520 --> 01:31:38,800 TYPE OF RESPONSES AND WHAT WE 1831 01:31:38,800 --> 01:31:42,640 CAN SAY IS THERE WERE MULTIPLE B 1832 01:31:42,640 --> 01:31:47,720 CELL OR LINEAGES IDENTIFIED. 1833 01:31:47,720 --> 01:31:49,120 THE TIER 2 NEUTRALIZATION HAS 1834 01:31:49,120 --> 01:31:52,000 BEEN THE BEST SO FAR. 1835 01:31:52,000 --> 01:31:55,280 THE VIRUSES BEING NEUTRALIZED 1836 01:31:55,280 --> 01:31:57,560 AND THE BETTER MEMORY CELLS 1837 01:31:57,560 --> 01:32:04,360 THAT'D PROPENSITY TO RECOGNIZE 1838 01:32:04,360 --> 01:32:05,920 NON-IMMUNODOMINANT EPITOPE. 1839 01:32:05,920 --> 01:32:10,040 WE'RE NOT INTERESTED IN DOMINANT 1840 01:32:10,040 --> 01:32:11,520 EPITOPES AT THE BASE WHICH ARE 1841 01:32:11,520 --> 01:32:11,840 DISTRACTING. 1842 01:32:11,840 --> 01:32:13,680 WE WANT TO EXPAND IT. 1843 01:32:13,680 --> 01:32:17,120 YOU CAN SEE HERE IN GROUP 3 AND 1844 01:32:17,120 --> 01:32:19,360 GROUP 2, FOR EXAMPLE, THEY HAVE 1845 01:32:19,360 --> 01:32:22,680 A MULTITUDE OF RESPONSES 1846 01:32:22,680 --> 01:32:25,360 COMPARED TO GROUP 1 WHICH WAS 1847 01:32:25,360 --> 01:32:28,720 NOT USING THE SNP ADJUVANT. 1848 01:32:28,720 --> 01:32:29,480 CHECKING A LOT OF BOXES THERE 1849 01:32:29,480 --> 01:32:35,240 WE'RE ENCOURAGED BY THAT. 1850 01:32:35,240 --> 01:32:36,920 NOW WE'VE MOVED BACK INTO 1851 01:32:36,920 --> 01:32:37,480 HUMANS. 1852 01:32:37,480 --> 01:32:39,680 THIS IS AN ADJUVANT COMPARISON 1853 01:32:39,680 --> 01:32:41,720 STUDY WHERE WE'RE LOOKING AT 1854 01:32:41,720 --> 01:32:43,960 MULTIPLE ADJUVANTS USING THE 1855 01:32:43,960 --> 01:32:47,800 SAME IMMUNOGEN WHICH IS A 1856 01:32:47,800 --> 01:32:48,760 STABILIZED TRIMER. 1857 01:32:48,760 --> 01:32:51,720 THIS STUDY OPENED A COUPLE YEARS 1858 01:32:51,720 --> 01:32:52,120 AGO. 1859 01:32:52,120 --> 01:32:55,720 IT HAD BEEN RUN INTO SOME SLOW 1860 01:32:55,720 --> 01:32:58,400 DOWNS WITH THE PANDEMIC BUT 1861 01:32:58,400 --> 01:33:00,280 BASICALLY PART A IS WHERE THEY 1862 01:33:00,280 --> 01:33:05,680 WERE DOING AN ESCALATION AND 1863 01:33:05,680 --> 01:33:08,600 SELECT THE HIGHER DOSE OF 5 1864 01:33:08,600 --> 01:33:10,640 MICROGRAMS AND FOUND INTERESTING 1865 01:33:10,640 --> 01:33:12,040 IMMUNE RESPONSES THAT MAY LEAD 1866 01:33:12,040 --> 01:33:17,560 TO A BROADER IMMUNE RESPONSE WAS 1867 01:33:17,560 --> 01:33:19,520 THAT ONE COMPARED TO OTHERS. 1868 01:33:19,520 --> 01:33:27,920 THE STUDY IS COMPLETELY ENROLLED 1869 01:33:27,920 --> 01:33:33,000 AND THEY'RE COMPLETING THESE AND 1870 01:33:33,000 --> 01:33:35,120 WE HAVE A PARALLEL PRIMATE STUDY 1871 01:33:35,120 --> 01:33:37,440 TO MATCH THE STUDY TO AGAIN 1872 01:33:37,440 --> 01:33:39,720 BEGIN TO GET MODELS LINED UP 1873 01:33:39,720 --> 01:33:42,400 WITH HUMANS TO GET MORE 1874 01:33:42,400 --> 01:33:43,560 INFORMATION AND TRY TO 1875 01:33:43,560 --> 01:33:44,120 ACCELERATE THE DEVELOPMENT 1876 01:33:44,120 --> 01:33:55,280 PROCESS. 1877 01:33:55,280 --> 01:33:59,640 THIS IS JUST A SUMMARY SLIDE 1878 01:33:59,640 --> 01:34:02,720 DALE IRVINE PRESENTED AND TIES 1879 01:34:02,720 --> 01:34:05,520 IN THE IDEAS I'VE BEEN BRINGING 1880 01:34:05,520 --> 01:34:08,920 TO YOU AS FAR AS ADJUVANTS, 1881 01:34:08,920 --> 01:34:16,960 IMMUNIZATION REGIMENTS, 1882 01:34:16,960 --> 01:34:18,560 FOLICULAR GERMAL CENTERS AND THE 1883 01:34:18,560 --> 01:34:20,400 ACTIVITIES BEING DONE IN THE 1884 01:34:20,400 --> 01:34:24,880 TRANSLATIONAL BRANCH WHERE THEY 1885 01:34:24,880 --> 01:34:29,600 TAKE THE IMMUNOGENS THAT LOOK 1886 01:34:29,600 --> 01:34:31,080 PROMISING IN THE PRE-CLINICAL 1887 01:34:31,080 --> 01:34:32,080 BRANCH AND ARE MANUFACTURING 1888 01:34:32,080 --> 01:34:34,480 THEM EITHER THROUGH CONTRACT 1889 01:34:34,480 --> 01:34:36,040 RESEARCH ORGANIZATION 1890 01:34:36,040 --> 01:34:37,560 MANUFACTURINGS OR THROUGH SOME 1891 01:34:37,560 --> 01:34:39,040 OF OUR OTHER FUNDED 1892 01:34:39,040 --> 01:34:43,720 INVESTIGATIVE SITES. 1893 01:34:43,720 --> 01:34:48,560 YOU CAN SEE NANO PARTICLES ARE 1894 01:34:48,560 --> 01:34:53,960 LISTED HERE VERY IMMUNOGENIC AND 1895 01:34:53,960 --> 01:34:54,800 MULTIPLE mRNA PROJECT WE'VE 1896 01:34:54,800 --> 01:34:56,760 BEEN FUNDING FOR A LONG TIME NOW 1897 01:34:56,760 --> 01:34:58,600 BEING ABLE TO BE TESTED AND ONE 1898 01:34:58,600 --> 01:35:02,320 OF THEM I'LL DRAW YOUR ATTENTION 1899 01:35:02,320 --> 01:35:10,480 TO WAS THIS MV39 THE TRIMER. 1900 01:35:10,480 --> 01:35:14,880 THIS IS THREE DIFFERENT VERSIONS 1901 01:35:14,880 --> 01:35:17,160 OF THE MD39 I BELIEVE THE STUDY 1902 01:35:17,160 --> 01:35:21,280 IS STARTING AND OPEN I THINK IN 1903 01:35:21,280 --> 01:35:26,720 LATE DECEMBER 302. 1904 01:35:26,720 --> 01:35:29,560 THE HIV mRNA STUDY LAUNCHED IN 1905 01:35:29,560 --> 01:35:31,280 PARALLEL IN ADVANCED FROM THE 1906 01:35:31,280 --> 01:35:40,160 PRIMATE MODEL I JUST PRESENTED. 1907 01:35:40,160 --> 01:35:41,600 HERE'S WHERE WE ARE TRYING TO 1908 01:35:41,600 --> 01:35:43,520 HIGHLIGHT ADJUVANT. 1909 01:35:43,520 --> 01:35:48,120 WE KNOW THERE'S ACCESS TO 1910 01:35:48,120 --> 01:35:54,520 ADJUVANTS AND WORKED WITH THE 1911 01:35:54,520 --> 01:36:00,000 DIVISION AND WE HAVE BEEN ABLE 1912 01:36:00,000 --> 01:36:04,920 TO ACQUIRE AND PRODUCE MANY 1913 01:36:04,920 --> 01:36:07,200 ADJUVANTS ON THE TABLE AND A 1914 01:36:07,200 --> 01:36:10,280 NEWLY COMPENDIUM THE LINK IS 1915 01:36:10,280 --> 01:36:13,040 HERE FOR YOU. 1916 01:36:13,040 --> 01:36:14,880 THAT'S RUN BUT WE'RE 1917 01:36:14,880 --> 01:36:15,560 COLLABORATING WITH THEM AS WELL 1918 01:36:15,560 --> 01:36:18,160 AND TO SHOW YOU THE ACTIVITIES 1919 01:36:18,160 --> 01:36:20,520 ARE HAPPENING TO MAKE SURE WE 1920 01:36:20,520 --> 01:36:25,960 HAVE THE CLINICAL RE-AGENTS FOR 1921 01:36:25,960 --> 01:36:34,840 OUR INVESTIGATE ERS . 1922 01:36:34,840 --> 01:36:50,280 AND HERE'S WHERE WE'RE AND WE 1923 01:36:50,280 --> 01:36:51,560 NEEDED TO TEST VARIOUS VACCINE 1924 01:36:51,560 --> 01:36:53,000 CONCEPTS SO I WANT TO GO TO THE 1925 01:36:53,000 --> 01:36:59,520 NEXT SLIDE TO REMIND YOU ABOUT 1926 01:36:59,520 --> 01:37:05,600 THE AMP STUDY. 1927 01:37:05,600 --> 01:37:12,120 SO THE AMP STUDY I WANTED TO 1928 01:37:12,120 --> 01:37:26,400 MAKE YOU AWARE IF THE VIRUS WAS 1929 01:37:26,400 --> 01:37:31,800 SUSCEPTIBLE AND THE HIGHLIGHT IS 1930 01:37:31,800 --> 01:37:38,360 IN RED, IF THE VIRUS WAS 1931 01:37:38,360 --> 01:37:41,600 SUSCEPTIBLE TO VRC01 THE 1932 01:37:41,600 --> 01:37:44,600 PREVENTIVE EFFICACY WAS 75% WITH 1933 01:37:44,600 --> 01:37:48,720 FW THE VIRUS WAS NOT SENSITIVE 1934 01:37:48,720 --> 01:37:50,880 VRC01 WAS NOT ABLE TO PREVENT 1935 01:37:50,880 --> 01:37:51,160 ACQUISITION. 1936 01:37:51,160 --> 01:37:53,120 THIS WAS A REAL ADVANCE. 1937 01:37:53,120 --> 01:37:55,400 WE KNOW WE CAN USE ANTIBODIES IN 1938 01:37:55,400 --> 01:37:55,720 VIVO. 1939 01:37:55,720 --> 01:38:02,000 AND THIS IS WHERE SOME OF OUR 1940 01:38:02,000 --> 01:38:09,240 NEXT STEPS ARE COMING WHERE 1941 01:38:09,240 --> 01:38:11,320 WE'LL SEE IF WE CAN PREVENT HIV 1942 01:38:11,320 --> 01:38:14,440 INFECTION WITH A TIGHTER 1943 01:38:14,440 --> 01:38:14,840 ANTIBODY. 1944 01:38:14,840 --> 01:38:17,120 AND FUTURE DIRECTIONS, I'LL SUM 1945 01:38:17,120 --> 01:38:17,560 UP. 1946 01:38:17,560 --> 01:38:18,760 THIS IS FOR YOUR INFORMATION. 1947 01:38:18,760 --> 01:38:20,280 I WON'T REVIEW ALL THIS BUT GIVE 1948 01:38:20,280 --> 01:38:22,560 YOU INFORMATION STUDIES BEING 1949 01:38:22,560 --> 01:38:25,800 DONE WITH THE ANTIBODIES MARKED 1950 01:38:25,800 --> 01:38:32,760 IN BLUE WITH THE mRNA s AND THIS 1951 01:38:32,760 --> 01:38:35,760 IS THE CHIP COLLABORATIVE 1952 01:38:35,760 --> 01:38:36,520 IMMUNOGEN PROJECT WHERE WE HAVE 1953 01:38:36,520 --> 01:38:39,520 TO WORK TOGETHER TO PRIORITIZE 1954 01:38:39,520 --> 01:38:46,880 WHICH ENVELOPE IMMUNIMMUNOGENS AND 1955 01:38:46,880 --> 01:38:48,400 THIS IS FOR YOUR INFORMATION AND 1956 01:38:48,400 --> 01:38:50,280 SHOULD BE INCLUDED IN YOUR BOOK 1957 01:38:50,280 --> 01:38:53,800 OR SLIDE DECK AND WOULD HELP US 1958 01:38:53,800 --> 01:39:00,920 SHEPHERD THE BROADLY 1959 01:39:00,920 --> 01:39:02,080 NEUTRALIZING RESPONSE AND SOME 1960 01:39:02,080 --> 01:39:07,480 OF THE TRIMERS USED ONCE PRIMED. 1961 01:39:07,480 --> 01:39:08,760 THESE ARE THE PROTOCOLS IN THE 1962 01:39:08,760 --> 01:39:14,480 PIPELINE FOR YOUR INFORMATION. 1963 01:39:14,480 --> 01:39:15,480 SO THANK YOU FOR ANY ADDITIONAL 1964 01:39:15,480 --> 01:39:21,600 TIME YOU GAVE ME THERE, KEN. 1965 01:39:21,600 --> 01:39:24,040 WE THINK THE FIELD VACCINE 1966 01:39:24,040 --> 01:39:27,720 DEVELOPMENT IS BRIGHT AND WE'RE 1967 01:39:27,720 --> 01:39:28,880 ACKNOWLEDGING THE COMMUNITY AND 1968 01:39:28,880 --> 01:39:32,680 PUBLIC PRIVATE PARTNERSHIPS AND 1969 01:39:32,680 --> 01:39:37,920 TRYING TO TAKE ADVANTAGE OF ALL 1970 01:39:37,920 --> 01:39:42,440 THE ADVANCES. 1971 01:39:42,440 --> 01:39:44,640 >> SO MUCH SCIENCE AND EXCITING 1972 01:39:44,640 --> 01:39:46,160 AND WE'RE A MINUTE BEHIND BUT 1973 01:39:46,160 --> 01:39:47,480 WE'LL TAKE A COUPLE MINUTES FOR 1974 01:39:47,480 --> 01:39:50,720 QUESTION AND I THINK WE'LL CATCH 1975 01:39:50,720 --> 01:39:52,120 UP AFTERWARDS. 1976 01:39:52,120 --> 01:39:53,240 QUESTIONS FOR MARY ABOUT THE 1977 01:39:53,240 --> 01:40:08,240 VACCINE PROGRAM? 1978 01:40:08,240 --> 01:40:10,520 >> IS THERE ANY INDICATION OF 1979 01:40:10,520 --> 01:40:24,280 WHICH ANIMAL MODEL FOR THE 1980 01:40:24,280 --> 01:40:26,880 HUMANS THAT DEVELOP THE BROAD 1981 01:40:26,880 --> 01:40:33,360 NEUTR 1982 01:40:33,360 --> 01:40:34,920 NEUTR 1983 01:40:34,920 --> 01:40:35,640 NEUTRALIZ 1984 01:40:35,640 --> 01:40:36,320 NEUTRALIZ 1985 01:40:36,320 --> 01:40:36,680 NEUTRALIZERS? 1986 01:40:36,680 --> 01:40:40,840 >> THE MOUSE MODELS CAN BE 1987 01:40:40,840 --> 01:40:48,880 CUSTOMIZED AND WE THINK THE 1988 01:40:48,880 --> 01:40:54,000 MOUSE MODEL THOUGH FOR THOSE OF 1989 01:40:54,000 --> 01:40:57,520 US HAVE BEEN IN THE FIELD THE 1990 01:40:57,520 --> 01:40:59,000 MOUSE MODEL HASN'T BEEN FAVORED 1991 01:40:59,000 --> 01:41:03,320 BUT IT'S SO MUCH FASTER WITH THE 1992 01:41:03,320 --> 01:41:04,080 GENETIC TECHNOLOGY. 1993 01:41:04,080 --> 01:41:05,520 SOME GROUPS ALMOST EXCLUSIVELY 1994 01:41:05,520 --> 01:41:07,200 USE THE MOUSE MODEL. 1995 01:41:07,200 --> 01:41:08,720 WE LIKE THE PRIMATE MODEL FOR 1996 01:41:08,720 --> 01:41:10,560 OTHER ATTRIBUTES AND CHALLENGE 1997 01:41:10,560 --> 01:41:13,680 THE FACT THEY DO GENERATE 1998 01:41:13,680 --> 01:41:17,080 BROADLY NEUTRALIZING ANTIBODIES, 1999 01:41:17,080 --> 01:41:18,440 AGAIN, IT'S A SMALL PERCENTAGE 2000 01:41:18,440 --> 01:41:20,320 OF ANIMALS BUT I THINK THE MOUSE 2001 01:41:20,320 --> 01:41:21,680 MODEL WOULD BE THE BIGGEST 2002 01:41:21,680 --> 01:41:23,520 ADVANCE IF I WERE TO ANSWER THAT 2003 01:41:23,520 --> 01:41:23,800 QUESTION. 2004 01:41:23,800 --> 01:41:24,720 >> THANK YOU. 2005 01:41:24,720 --> 01:41:28,000 I THINK THE HUMANIZATION OF THE 2006 01:41:28,000 --> 01:41:33,840 MODEL IS A PRETTY IMPORTANT STEP 2007 01:41:33,840 --> 01:41:34,320 FORWARD. 2008 01:41:34,320 --> 01:41:37,040 SOME DIFFERENCES IN THE 2009 01:41:37,040 --> 01:41:39,280 ACTIVATION THAT DRIVES THE 2010 01:41:39,280 --> 01:41:40,720 ANTIBODY THAT COULD DETERMINE A 2011 01:41:40,720 --> 01:41:43,080 REPERTOIRE ALSO. 2012 01:41:43,080 --> 01:41:45,280 >> I TOTALLY AGREE WITH YOU. 2013 01:41:45,280 --> 01:41:47,200 WE HAVE TO TAKE THAT WITH A 2014 01:41:47,200 --> 01:41:49,640 GRAIN OF SALT THIS WHOLE LIKE 2015 01:41:49,640 --> 01:41:51,520 THE ONLY LIVE TWO YEARS OR 2016 01:41:51,520 --> 01:41:52,440 SOMETHING AND WE'RE TALKING 2017 01:41:52,440 --> 01:41:54,120 ABOUT COMPRESSING ALL THAT. 2018 01:41:54,120 --> 01:41:55,520 IT'S SO EXCITING THOUGH THAT 2019 01:41:55,520 --> 01:41:59,320 SOME OF THE THINGS THAT WE'VE 2020 01:41:59,320 --> 01:42:01,000 SEEN IN THE MOUSE MODEL HAS 2021 01:42:01,000 --> 01:42:07,800 BEGUN TO COME FORWARD IN HUMANS. 2022 01:42:07,800 --> 01:42:10,400 A LOT OF THAT WILL NOT BE 2023 01:42:10,400 --> 01:42:10,680 IDENTICAL. 2024 01:42:10,680 --> 01:42:11,560 >> A LAST QUESTION FROM KEITH 2025 01:42:11,560 --> 01:42:12,520 AND THEN A BREAK. 2026 01:42:12,520 --> 01:42:13,400 >> SURE. 2027 01:42:13,400 --> 01:42:16,400 I ENJOYED THE SLIDE ABOUT THE 2028 01:42:16,400 --> 01:42:19,240 VALUE AND THE WORKSHOP ABOUT THE 2029 01:42:19,240 --> 01:42:21,640 VALUE OF THE HIV EFFORTS TOWARDS 2030 01:42:21,640 --> 01:42:24,360 THE COVID VACCINE AND HAD A 2031 01:42:24,360 --> 01:42:26,880 BULLET ABOUT OF THIS KIND OF 2032 01:42:26,880 --> 01:42:28,600 WORKING IN REVERSE AND BEING 2033 01:42:28,600 --> 01:42:31,920 INVOLVED WITH A HYBRID PROGRAM 2034 01:42:31,920 --> 01:42:34,440 AND A TREMENDOUS NGS AND ROBOTIC 2035 01:42:34,440 --> 01:42:38,960 ROBOTICS AND SO FORTH WE'RE 2036 01:42:38,960 --> 01:42:39,640 THINKING ABOUT WHAT HAPPENS WHEN 2037 01:42:39,640 --> 01:42:42,120 WE GET TO THE PROMISED LAND 2038 01:42:42,120 --> 01:42:44,520 COVID IS MAYBE NOT THE ABSOLUTE 2039 01:42:44,520 --> 01:42:45,600 OVERWHELMING EMERGENCY AND HOW 2040 01:42:45,600 --> 01:42:47,080 TO LEVERAGE THAT. 2041 01:42:47,080 --> 01:42:48,720 I'M WONDERING IF YOU CAN EXPAND 2042 01:42:48,720 --> 01:42:49,800 ON WHETHER THERE'S FORMAL 2043 01:42:49,800 --> 01:42:52,480 EFFORTS TO THINK OF LEVERAGING 2044 01:42:52,480 --> 01:42:54,160 THIS HUGE INVESTMENT MADE OVER 2045 01:42:54,160 --> 01:42:55,520 THE PAST TWO YEARS FOR THINGS 2046 01:42:55,520 --> 01:43:02,400 LIKE HIV AND LONGER TERM 2047 01:43:02,400 --> 01:43:02,680 PROBLEMS. 2048 01:43:02,680 --> 01:43:04,400 >> OH, YEAH. 2049 01:43:04,400 --> 01:43:07,120 I PROBABLY WOULDN'T BE THE 2050 01:43:07,120 --> 01:43:10,280 WORLD'S BEST EXPERT BUT IF I CAN 2051 01:43:10,280 --> 01:43:15,320 MAKE ONE COMMENT SAY FOR EXAMPLE 2052 01:43:15,320 --> 01:43:20,720 REGARDING THE AMP STUDY, WE 2053 01:43:20,720 --> 01:43:26,520 OVEREST MATE THE CIRCULATING 2054 01:43:26,520 --> 01:43:28,520 STRAINS -- OVER ESTIMATED THE 2055 01:43:28,520 --> 01:43:31,240 CIRCULATING STRAINS AND COULD BE 2056 01:43:31,240 --> 01:43:35,520 PROBABLY BETTER INFORMED WITH 2057 01:43:35,520 --> 01:43:36,920 THE EVOLUTION OF THE HIV 2058 01:43:36,920 --> 01:43:38,720 EPIDEMIC WHICH HAS CHANGED GIVEN 2059 01:43:38,720 --> 01:43:44,080 THE TYPE OF VIRUS AND THE OTHER 2060 01:43:44,080 --> 01:43:49,800 CONDITIONS THE ONGOING EPIDEMIC 2061 01:43:49,800 --> 01:43:52,800 FOLKS ARE FACING AND WOULD BE 2062 01:43:52,800 --> 01:44:00,200 WELL SUITED FOR THE RESEARCH IN 2063 01:44:00,200 --> 01:44:05,520 GENER 2064 01:44:05,520 --> 01:44:05,720 GENERAL. 2065 01:44:05,720 --> 01:44:07,840 WE'LL TAKE A BREAK. 2066 01:44:07,840 --> 01:44:11,640 >> HOW ABOUT WE TAKE AN EIGHT 2067 01:44:11,640 --> 01:44:14,560 MINUTE BREAK. 2068 01:44:14,560 --> 01:44:20,080 AND WE HAVE FOUR MORE GROUPS SO 2069 01:44:20,080 --> 01:44:21,520 TAKE A BREAK STRETCH YOUR LEGS 2070 01:44:21,520 --> 01:44:22,280 AND WE'LL BE BACK. 2071 01:44:22,280 --> 01:44:24,960 WELCOME BACK, EVERYONE. 2072 01:44:24,960 --> 01:44:26,400 DOESN'T LOOK LIKE WE LOST TOO 2073 01:44:26,400 --> 01:44:28,560 MANY PEOPLE, IF ANYONE AT ALL. 2074 01:44:28,560 --> 01:44:33,040 AND SO I WAS PROMISED WE'D PICK 2075 01:44:33,040 --> 01:44:34,880 UP A MINUTE OR SO PER PROGRAM SO 2076 01:44:34,880 --> 01:44:36,560 WE'LL END ON TIME. 2077 01:44:36,560 --> 01:44:39,880 LET ME HAND IT OVER TO PETER KIM 2078 01:44:39,880 --> 01:44:40,880 OF THE THERAPEUTICS RESEARCH 2079 01:44:40,880 --> 01:44:41,280 PROGRAM. 2080 01:44:41,280 --> 01:44:42,280 WE LOOK FORWARD TO HEARING FROM 2081 01:44:42,280 --> 01:44:46,440 YOU. 2082 01:44:46,440 --> 01:44:46,840 GREAT. 2083 01:44:46,840 --> 01:44:52,000 HOPEFULLY EVERYONE CAN SEE ME 2084 01:44:52,000 --> 01:44:59,480 AND SO GOOD AFTERNOON EVERYONE. 2085 01:44:59,480 --> 01:45:00,720 IT'S A PLEASURE TO BE HERE TODAY 2086 01:45:00,720 --> 01:45:03,480 AND TO PRESENT TO YOU SOME OF 2087 01:45:03,480 --> 01:45:06,280 THE RECENT ADVANCES AND UPDATES 2088 01:45:06,280 --> 01:45:06,880 TO THE THERAPEUTIC RESEARCH 2089 01:45:06,880 --> 01:45:28,960 PROGRAM. 2090 01:45:28,960 --> 01:45:30,840 IT LOOKS LIKE I DON'T HAVE 2091 01:45:30,840 --> 01:45:31,280 CONTROL. 2092 01:45:31,280 --> 01:45:33,080 >> THERE WASN'T A NEED TO GO 2093 01:45:33,080 --> 01:45:34,360 THAT FAST, PETER. 2094 01:45:34,360 --> 01:45:36,360 >> A CUMULATED ALL THE KEY 2095 01:45:36,360 --> 01:45:42,480 STROKES AND DID IT ALL AT ONCE. 2096 01:45:42,480 --> 01:45:43,720 THERE'S A LAG. 2097 01:45:43,720 --> 01:45:45,560 RYAN, MAYBE YOU CAN TAKE CONTROL 2098 01:45:45,560 --> 01:46:03,880 AND ADVANCE FOR ME. 2099 01:46:03,880 --> 01:46:07,360 IT IS NOT ADVANCING AT ALL, 2100 01:46:07,360 --> 01:46:07,920 PETER? 2101 01:46:07,920 --> 01:46:10,200 DOES IT ADVANCE ON YOUR END OR 2102 01:46:10,200 --> 01:46:17,480 IS IT STUCK? 2103 01:46:17,480 --> 01:46:17,680 OKAY. 2104 01:46:17,680 --> 01:46:20,000 SO JUST TO START AGAIN. 2105 01:46:20,000 --> 01:46:21,720 SO I'D LIKE TO JUST THANK FIRST 2106 01:46:21,720 --> 01:46:24,080 OF ALL BEFORE I HEAD INTO THE 2107 01:46:24,080 --> 01:46:27,840 PRESENTATION THE MANY MEMBERS OF 2108 01:46:27,840 --> 01:46:29,640 THE THERAPEUTIC RESEARCH 2109 01:46:29,640 --> 01:46:29,880 PROGRAM. 2110 01:46:29,880 --> 01:46:32,680 I'M SIMPLY HERE ON THEIR BEHALF 2111 01:46:32,680 --> 01:46:34,000 AND THE WORK I'M ABOUT TO 2112 01:46:34,000 --> 01:46:36,480 PRESENT IS MADE POSSIBLE BECAUSE 2113 01:46:36,480 --> 01:46:39,760 OF THEIR WORK AND EFFORTS THEY 2114 01:46:39,760 --> 01:46:42,480 HAVE PUT INTO THE PROGRAM IN 2115 01:46:42,480 --> 01:46:43,360 ADMINISTRATING THE GRANTS AND 2116 01:46:43,360 --> 01:46:45,120 CONTRACTS WE OVERSEE IN THE PAST 2117 01:46:45,120 --> 01:46:45,320 YEAR. 2118 01:46:45,320 --> 01:46:48,160 I WILL SAY THAT BEING ON A FULL 2119 01:46:48,160 --> 01:46:51,280 100% TELEWORK ENVIRONMENT IS NOT 2120 01:46:51,280 --> 01:46:53,120 ALWAYS EASY BUT OUR STAFF HAD 2121 01:46:53,120 --> 01:46:54,080 REALLY SHOWN A LOT OF RESILIENCE 2122 01:46:54,080 --> 01:46:56,280 THIS PAST YEAR AND IT'S BEEN 2123 01:46:56,280 --> 01:47:01,040 EXCELLENT TO SEE THAT WE CAN 2124 01:47:01,040 --> 01:47:02,840 STILL ADVANCE REALLY CRITICAL 2125 01:47:02,840 --> 01:47:05,680 THERAPEUTIC SCIENCE DESPITE THE 2126 01:47:05,680 --> 01:47:07,520 CHALLENGES THE COVID-19 PANDEMIC 2127 01:47:07,520 --> 01:47:38,720 HAS THROWN OUR WAY. 2128 01:47:38,720 --> 01:47:46,200 SO IMPORTANT TRANSITIONS IN TRP. 2129 01:47:46,200 --> 01:47:53,160 WE HAD BRANCH CHIEFS RETIRE THIS 2130 01:47:53,160 --> 01:47:53,480 YEAR. 2131 01:47:53,480 --> 01:47:53,760 T 2132 01:47:53,760 --> 01:47:54,720 ONE HAD BEEN INVOLVED WITH THE 2133 01:47:54,720 --> 01:47:57,440 DIVISION OF AIDS ON ALMOST SINCE 2134 01:47:57,440 --> 01:48:02,120 THE VERY BEGINNING HAD RETIRED 2135 01:48:02,120 --> 01:48:08,080 THIS PAST YEAR AND DR. JOE 2136 01:48:08,080 --> 01:48:08,880 FITZGIBBON IN THE DRUG 2137 01:48:08,880 --> 01:48:10,160 DEVELOPMENT CLINICAL SCIENCES 2138 01:48:10,160 --> 01:48:12,960 BRANCH CHIEF RETIRED AFTER 20 2139 01:48:12,960 --> 01:48:14,040 YEARS OF SERVICE. 2140 01:48:14,040 --> 01:48:16,680 THEY BOTH LEAVE IMPORTANT 2141 01:48:16,680 --> 01:48:19,440 LEGACIES IN TRP AND OVERALL IN 2142 01:48:19,440 --> 01:48:20,400 THE DIVISION AND THEY'LL BE 2143 01:48:20,400 --> 01:48:26,480 SORELY MISSED. 2144 01:48:26,480 --> 01:48:29,640 AND ONE NEW ANNOUNCEMENT 2145 01:48:29,640 --> 01:48:33,320 PRESENTED DR. FATIMA JONES HAS 2146 01:48:33,320 --> 01:48:35,040 TAKEN OVER AS OF DECEMBER OF 2147 01:48:35,040 --> 01:48:37,680 LAST YEAR. 2148 01:48:37,680 --> 01:48:41,560 I WILL KNOW THAT DR. JONES IS A 2149 01:48:41,560 --> 01:48:43,240 WELCOMED ADDITION TO OUR PROGRAM 2150 01:48:43,240 --> 01:48:45,680 AS MANY PEOPLE HAVE NOTED. 2151 01:48:45,680 --> 01:48:50,480 UNFORTUNATELY, WE DO NOT HAVE A 2152 01:48:50,480 --> 01:48:53,720 REPLACEMENT FOR DR. HAGNER IF 2153 01:48:53,720 --> 01:48:55,760 PEOPLE KNOW OF SOMEONE LOOKING 2154 01:48:55,760 --> 01:49:02,280 TO FIND A CAREER AT THE NIH 2155 01:49:02,280 --> 01:49:12,560 REACH OUT TO ME. 2156 01:49:12,560 --> 01:49:13,840 THE THERAPEUTIC RESEARCH PROGRAM 2157 01:49:13,840 --> 01:49:16,680 HAS IN OPPOSITION TO THE BASIC 2158 01:49:16,680 --> 01:49:19,560 VACCINE RESEARCH PROGRAM HAS 2159 01:49:19,560 --> 01:49:20,480 SOMEWHAT BROADER AGENDA AND 2160 01:49:20,480 --> 01:49:21,360 MISSION. 2161 01:49:21,360 --> 01:49:23,400 OUR GOAL IS TO IMPROVE THE 2162 01:49:23,400 --> 01:49:25,200 HEALTH OF PEOPLE LIVING WITH HIV 2163 01:49:25,200 --> 01:49:28,800 BY DEVELOPING NEW AND IMPROVING 2164 01:49:28,800 --> 01:49:30,640 THERAPEUTICS AND DIAGNOSTICS IN 2165 01:49:30,640 --> 01:49:34,280 ASSOCIATED STRATEGIES TO ACHIEVE 2166 01:49:34,280 --> 01:49:37,440 VIRAL SUPPRESSION AND REMISSION. 2167 01:49:37,440 --> 01:49:38,680 HEALTH OUTCOMES IN PEOPLE LIVING 2168 01:49:38,680 --> 01:49:41,400 WITH HIV ARE NOT JUST ASSOCIATED 2169 01:49:41,400 --> 01:49:43,120 WITH THE HIV INFECTION ITSELF 2170 01:49:43,120 --> 01:49:45,480 AND BASED ON ALSO A NUMBER OF 2171 01:49:45,480 --> 01:49:47,680 CO-INFECTIONS AND COMORBIDITIES. 2172 01:49:47,680 --> 01:49:50,280 WE ALSO FOCUS ON THOSE DISEASES 2173 01:49:50,280 --> 01:49:52,880 TO REALLY MAKE AN OVERALL IMPACT 2174 01:49:52,880 --> 01:49:54,280 ON THE HEALTH OF PEOPLE WITH 2175 01:49:54,280 --> 01:50:01,280 HIV. 2176 01:50:01,280 --> 01:50:04,400 SO THOUGH WE IN TRP HAVE A 2177 01:50:04,400 --> 01:50:06,280 FAIRLY BROAD PORTFOLIO OF GRANTS 2178 01:50:06,280 --> 01:50:08,120 AND CONTRACTS AND COOPERATIVE 2179 01:50:08,120 --> 01:50:11,680 AGREEMENTS THAT ARE BOTH 2180 01:50:11,680 --> 01:50:13,240 TRANSLATIONAL AND CLINICAL IN 2181 01:50:13,240 --> 01:50:15,720 NATURAL, MOST OF OUR ACTIVITIES 2182 01:50:15,720 --> 01:50:17,480 ARE WEIGHTED TOWARDS CLINICAL 2183 01:50:17,480 --> 01:50:20,320 TRIALS WITH MORE THAN 80 2184 01:50:20,320 --> 01:50:22,480 CLINICAL TRIALS ACTIVE AND/OR IN 2185 01:50:22,480 --> 01:50:23,080 DEVELOPMENT. 2186 01:50:23,080 --> 01:50:25,480 THE NUMBER IS SLIGHTLY HIGHER 2187 01:50:25,480 --> 01:50:27,320 THAN MY PRESENTATIONS FROM 2188 01:50:27,320 --> 01:50:28,360 RECENT PAST. 2189 01:50:28,360 --> 01:50:30,600 LAST YEAR WE HAD ABOUT 70 IN 2190 01:50:30,600 --> 01:50:33,840 DEVELOPMENT AND THE REASON BEING 2191 01:50:33,840 --> 01:50:35,280 PARTLY BECAUSE OF THE DELAYS 2192 01:50:35,280 --> 01:50:36,280 CAUSED BY THE COVID-19 PANDEMIC 2193 01:50:36,280 --> 01:50:42,280 AND PARTLY BECAUSE OF A NEW 2194 01:50:42,280 --> 01:50:42,880 SCIENCE WITH IMPORTANT 2195 01:50:42,880 --> 01:51:06,680 OPPORTUNITIES IN THE FIELD. 2196 01:51:06,680 --> 01:51:12,560 IN 2021 WE HAD 16 FOAs AND SOME 2197 01:51:12,560 --> 01:51:14,840 HAD SET ASIDE FUNDING AND SOME 2198 01:51:14,840 --> 01:51:17,840 DID NOT FOR THE SAKE OF KEEPING 2199 01:51:17,840 --> 01:51:21,080 THIS MOVING FORWARD I WILL NOTE 2200 01:51:21,080 --> 01:51:26,600 THAT OUR FOAs AGAIN MATCHING OUR 2201 01:51:26,600 --> 01:51:28,880 OVERALL BROAD AGENDA DIVERSIFIED 2202 01:51:28,880 --> 01:51:32,920 ACROSS NOT ONLY HIV BUT T.B., 2203 01:51:32,920 --> 01:51:34,440 HEPATITIS AND OTHER FIELD OF 2204 01:51:34,440 --> 01:51:34,680 INTEREST. 2205 01:51:34,680 --> 01:51:36,560 THE OTHER NOTE I'LL MAKE IS OVER 2206 01:51:36,560 --> 01:51:38,280 THE PAST COUPLE YEARS I'VE 2207 01:51:38,280 --> 01:51:39,680 NOTICED A TREND TOWARDS 2208 01:51:39,680 --> 01:51:40,640 INCREASING COLLABORATION WITH 2209 01:51:40,640 --> 01:51:43,240 OTHER PROGRAMS, DIVISIONS AND 2210 01:51:43,240 --> 01:51:45,240 I.C.s ACROSS THE NIH WHICH I 2211 01:51:45,240 --> 01:51:46,280 THINK IS AN IMPORTANT AND 2212 01:51:46,280 --> 01:51:46,920 POSITIVE DEVELOPMENT. 2213 01:51:46,920 --> 01:51:48,280 I THINK PART OF THE REASON FOR 2214 01:51:48,280 --> 01:51:52,040 THIS IS THAT WE'RE MAKING A 2215 01:51:52,040 --> 01:51:52,880 CONSCIOUS EFFORT TOWARDS GREATER 2216 01:51:52,880 --> 01:51:54,280 COLLABORATIVE APPROACHES AND 2217 01:51:54,280 --> 01:51:59,040 ALSO IT SPEAKS TO THE CHANGING 2218 01:51:59,040 --> 01:52:00,840 NATURE OF THE SCIENCE WHERE MANY 2219 01:52:00,840 --> 01:52:02,440 PREVIOUSLY DISPARATE AREAS OF 2220 01:52:02,440 --> 01:52:10,080 SCIENCE ARE EMERGING IN 2221 01:52:10,080 --> 01:52:17,680 ADDRESSING HIV OVERALL. 2222 01:52:17,680 --> 01:52:24,000 FROM THIS POINT ON I'LL DELVE 2223 01:52:24,000 --> 01:52:27,080 INTO OUR AREAS OF AREAS OF 2224 01:52:27,080 --> 01:52:31,120 INTERESTING, HIV, HIV-ASSOCIATED 2225 01:52:31,120 --> 01:52:35,040 COMORBIDITITIEY 2226 01:52:35,040 --> 01:52:43,000 COMORBIDITITIIES AND T.B. AND 2227 01:52:43,000 --> 01:52:47,480 HEPATITIS AND TO DEVELOP HOME 2228 01:52:47,480 --> 01:52:50,360 BASED CARE AND POINT-OF-CARE 2229 01:52:50,360 --> 01:52:51,640 HOME-BASED DIAGNOSTICS AND 2230 01:52:51,640 --> 01:52:54,920 REMISSION AND CURE AND ADDRESS 2231 01:52:54,920 --> 01:52:57,760 KEY COMORBIDITIES MAINLY THROUGH 2232 01:52:57,760 --> 01:53:11,680 COLLABORATIONS AS SAID BEFORE. 2233 01:53:11,680 --> 01:53:13,280 THERE SEEMS TO BE A SIGNIFICANT 2234 01:53:13,280 --> 01:53:13,640 LAG. 2235 01:53:13,640 --> 01:53:15,880 I'LL TRY TO SWITCH DEVICES. 2236 01:53:15,880 --> 01:53:18,280 GIVE ME ONE SECOND, PLEASE. 2237 01:53:18,280 --> 01:53:27,920 SORRY ABOUT THIS. 2238 01:53:27,920 --> 01:53:30,280 >> CAN ANYONE ELSE CONFIRM THE 2239 01:53:30,280 --> 01:53:31,080 SLIDES ARE ADVANCING. 2240 01:53:31,080 --> 01:53:33,640 I THINK IT'S LAGGING ON HIS END. 2241 01:53:33,640 --> 01:53:55,480 >> WE CAN SEE THEM ADVANCING. 2242 01:53:55,480 --> 01:53:56,640 ONE RECENT ADVANCE WE WERE ABLE 2243 01:53:56,640 --> 01:53:59,160 TO CONTRIBUTE TO IS THE 2244 01:53:59,160 --> 01:54:00,480 DISCOVERY AND DEVELOPMENT OF A 2245 01:54:00,480 --> 01:54:07,360 NEW FIRST IN CLASS ANTI-HIV 2246 01:54:07,360 --> 01:54:17,040 DRUG, STP 0404 AN INHIBITOR AND 2247 01:54:17,040 --> 01:54:20,720 THEY WERE ABLE TO BOTH DISCOVER 2248 01:54:20,720 --> 01:54:23,440 THIS NEW DRUG WHICH IS A 2249 01:54:23,440 --> 01:54:28,400 NON-CATALYTIC BINDER TOE THE 2250 01:54:28,400 --> 01:54:30,680 INTEGRASE INHIBITION SITE IN HIV 2251 01:54:30,680 --> 01:54:33,680 AND ALSO IS A HIGHLY POTENT NEW 2252 01:54:33,680 --> 01:54:36,520 COMPOUND THAT HAS ALREADY 2253 01:54:36,520 --> 01:54:38,320 ENTERED PHASE 1 CLINICAL TESTING 2254 01:54:38,320 --> 01:54:42,320 AND ALSO HAS POSSIBILITIES FOR 2255 01:54:42,320 --> 01:54:46,880 LONG-ACTING FORMULATION IN 2256 01:54:46,880 --> 01:54:47,880 DEVELOPMENT AND I THINK HAS TO 2257 01:54:47,880 --> 01:54:49,040 NEW CLASSES OF DRUGS ARE 2258 01:54:49,040 --> 01:54:50,880 IMPORTANT TO MAKE SURE WE KEEP 2259 01:54:50,880 --> 01:54:53,000 THE FIELD MOVING AND RESISTANT 2260 01:54:53,000 --> 01:54:54,960 TO DEVELOPMENT OF RESISTANCE TO 2261 01:54:54,960 --> 01:54:59,200 HIV AND I THINK NOW IT'S COMMON 2262 01:54:59,200 --> 01:55:02,280 KNOWLEDGE AND COMMONLY ACCEPTED 2263 01:55:02,280 --> 01:55:04,040 LONG-ACTING FORMULATIONS CAN 2264 01:55:04,040 --> 01:55:05,960 HAVE AN IMPACT ON THE PANDEMIC 2265 01:55:05,960 --> 01:55:08,680 OF HIV AND WE'RE GLAD TO BE 2266 01:55:08,680 --> 01:55:17,760 SUPPORTING GRANTS LIKE THIS. 2267 01:55:17,760 --> 01:55:20,280 IN THE FIELD OF UNDERSTANDING 2268 01:55:20,280 --> 01:55:28,400 HIV AND IV CURE WE IDENTIFIED 2269 01:55:28,400 --> 01:55:29,880 METABOLIC BIOMARKERS THAT MAY 2270 01:55:29,880 --> 01:55:31,560 PREDICT POST-TREATMENT CONTROL 2271 01:55:31,560 --> 01:55:33,920 OF HIV. 2272 01:55:33,920 --> 01:55:37,080 THIS PARTICULAR EXPERIMENT THE 2273 01:55:37,080 --> 01:55:38,800 INVESTIGATORS TOOK SAMPLES OF 2274 01:55:38,800 --> 01:55:43,080 HIV FROM A COHORT OF 2275 01:55:43,080 --> 01:55:48,120 PARTICIPANTS THAT HAD UNDER GONE 2276 01:55:48,120 --> 01:55:55,960 INTERRUPTIONS AND LOOKING AT THE 2277 01:55:55,960 --> 01:55:57,960 MRAZ THAT 2278 01:55:59,440 --> 01:56:02,280 THEY WERE ABLE TO PREDICT TIME 2279 01:56:02,280 --> 01:56:04,080 TO REBOUND WITH 74% CAPACITY AND 2280 01:56:04,080 --> 01:56:07,680 ALSO THE PROBABILITY OF OVERALL 2281 01:56:07,680 --> 01:56:08,920 VIRAL REMISSION WITH THE 97.5% 2282 01:56:08,920 --> 01:56:17,280 CAPACITY. 2283 01:56:17,280 --> 01:56:19,400 THIS IS EARLY WORK AND SOME 2284 01:56:19,400 --> 01:56:20,880 NEEDS TO TAKE PLACE FOR CLINICAL 2285 01:56:20,880 --> 01:56:23,440 UTILITY AND AS PREDICTED 2286 01:56:23,440 --> 01:56:26,280 BIOMARKERS AND DESIGN OF OUR 2287 01:56:26,280 --> 01:56:27,280 CURE HIV CLINICAL TRIALS. 2288 01:56:27,280 --> 01:56:28,880 WE THINK IT'S A PROMISING 2289 01:56:28,880 --> 01:56:30,840 ADVANCEMENT AND LOOK FORWARD TO 2290 01:56:30,840 --> 01:56:31,480 ADVANCING THIS AREA OF RESEARCH 2291 01:56:31,480 --> 01:56:44,480 FURTHER. 2292 01:56:44,480 --> 01:56:47,400 WE ALSO WORKED WITH A LAB AND 2293 01:56:47,400 --> 01:56:50,720 FOUND HIV HAS THE ABILITY TO 2294 01:56:50,720 --> 01:56:57,560 BUILD RECIVILITIAN RESISTANCE AND THEY TOO K 2295 01:56:57,560 --> 01:57:01,240 BLOOD SAMPLES AND FOUND THE 2296 01:57:01,240 --> 01:57:04,880 VIRUSES THAT SUCCESSFULLY REVAKT 2297 01:57:04,880 --> 01:57:09,880 REVAKT -- REACTIVATE ARE 2298 01:57:09,880 --> 01:57:12,920 RESISTANT AND DURING ACUTE 2299 01:57:12,920 --> 01:57:14,080 INFECTION THERE'S HIGH 2300 01:57:14,080 --> 01:57:15,520 RESISTANCE AND AFTER THE FIRST 2301 01:57:15,520 --> 01:57:20,080 YEAR WHILE ON TREATMENT THE 2302 01:57:20,080 --> 01:57:21,200 RESISTANCE GOES DOWN BUT ONCE 2303 01:57:21,200 --> 01:57:23,760 TREATMENT IS TAKEN AWAY AND THE 2304 01:57:23,760 --> 01:57:25,200 VIRUSES REBOUND AGAIN THERE'S A 2305 01:57:25,200 --> 01:57:27,880 HIGH RATE OF RESISTANCE AMONG 2306 01:57:27,880 --> 01:57:29,760 THE VIRUS SHOWING THAT THE HIV 2307 01:57:29,760 --> 01:57:34,600 HAS THE ABILITY TO EVOLVE 2308 01:57:34,600 --> 01:57:35,480 RESISTANCE AGAINST THE 2309 01:57:35,480 --> 01:57:45,760 RESPONSES. 2310 01:57:45,760 --> 01:57:48,080 WE HAVE A CLINICAL TRIAL CALLED 2311 01:57:48,080 --> 01:57:50,880 THE REPRIEVE STUDY AND THEY TOOK 2312 01:57:50,880 --> 01:57:55,000 A SUB COHORT OF PARTICIPANTS 2313 01:57:55,000 --> 01:57:59,880 ENROLLED AND PERFORMED C.T. 2314 01:57:59,880 --> 01:58:08,080 ANGIOGRAPHY LOOKING FOR PLAQUES 2315 01:58:08,080 --> 01:58:12,560 AND THE EXISTENCE OF THE 2316 01:58:12,560 --> 01:58:15,400 CORONARY PLAQUE WAS ASSOCIATED 2317 01:58:15,400 --> 01:58:20,360 WITH IMMUNE AND INFLAMMATION AND 2318 01:58:20,360 --> 01:58:22,920 ACTIVATION MARKERS THOUGH IT WAS 2319 01:58:22,920 --> 01:58:24,400 RARE BUT HIGH-RISK PLAQUE WAS 2320 01:58:24,400 --> 01:58:49,800 SEEN IN 20% OF THE PARTICIPANTS. 2321 01:58:49,800 --> 01:58:52,040 THERE'S A CLINICAL TRIAL TO LOOK 2322 01:58:52,040 --> 01:58:54,120 IN PERSONS WITH HIV AND THIS 2323 01:58:54,120 --> 01:58:55,720 STUDY WILL COMPARE VIRAL CONTROL 2324 01:58:55,720 --> 01:59:02,000 DURING ATI BY STUDY ARMS AND 2325 01:59:02,000 --> 01:59:08,080 HISTORICAL CONTROLS IT'S 2326 01:59:08,080 --> 01:59:12,040 IMPORTANT TO LOOK AT THE 2327 01:59:12,040 --> 01:59:13,120 ANTIBIOTICS WITH OTHER AGENTS TO 2328 01:59:13,120 --> 01:59:18,320 SEE WHAT IMPACT THEY HAVE ON THE 2329 01:59:18,320 --> 01:59:22,320 RESERVOIR AND POSSIBILITY OF HIV 2330 01:59:22,320 --> 01:59:26,480 CURE AND REMISSION. 2331 01:59:26,480 --> 01:59:32,480 BEYOND PASSIVE INFUSION OF BROAD 2332 01:59:32,480 --> 01:59:35,640 NEUTRALIZING ANTIBODIES WE 2333 01:59:35,640 --> 01:59:38,040 BELIEVE THE VACCINES MAY HAVE A 2334 01:59:38,040 --> 01:59:40,280 THERAPEUTIC BENEFIT FOR PERSONS 2335 01:59:40,280 --> 01:59:43,960 LIVING WITH HIV. 2336 01:59:43,960 --> 01:59:45,400 WE'RE FUNDING PHASE 1 CLINICAL 2337 01:59:45,400 --> 01:59:47,400 TRIALS TO EVALUATE THIS CONCEPT 2338 01:59:47,400 --> 01:59:50,280 LOOKING AT THE SAFETY, 2339 01:59:50,280 --> 01:59:51,520 TOLERABILITY AND IMMUNOGENICITY 2340 01:59:51,520 --> 01:59:54,800 OF THE ENVELOPE PROTEIN IN HIV 2341 01:59:54,800 --> 01:59:56,320 INFECTED ADULTS. 2342 01:59:56,320 --> 01:59:57,760 FROM A LARGER PERSPECTIVE WE'RE 2343 01:59:57,760 --> 02:00:00,040 ALSO WORKING IN CONJUNCTION WITH 2344 02:00:00,040 --> 02:00:04,320 THE ACTG TO DEVELOP A PLATFORM 2345 02:00:04,320 --> 02:00:07,200 OR MASTER TRIAL TO TEST MULTIPLE 2346 02:00:07,200 --> 02:00:14,280 IMMUNOGEN FOR RESPONSE FOR 2347 02:00:14,280 --> 02:00:25,600 PEOPLE LIVING WITH HIV. 2348 02:00:25,600 --> 02:00:26,760 PROGRESSING ON THE CASCADE OF 2349 02:00:26,760 --> 02:00:31,040 THE CLINICAL TRIAL WITH THE 2350 02:00:31,040 --> 02:00:36,480 PRIMARY ON THE OBJECTIVE TO 2351 02:00:36,480 --> 02:00:37,960 DIFFERENCES IN THE WEIGHT CHANGE 2352 02:00:37,960 --> 02:00:39,840 OVER 48 WEEKS COMPARED TO 2353 02:00:39,840 --> 02:00:43,760 REMAINING INHIBITER CONTAINING 2354 02:00:43,760 --> 02:00:44,760 REGIMENT. 2355 02:00:44,760 --> 02:00:46,280 IT'S LOOKING TO ABOUT 2200 2356 02:00:46,280 --> 02:00:46,880 PARTICIPANTS AND THOUGH THE 2357 02:00:46,880 --> 02:00:48,880 TRIAL HAS SOME WAYS TO GO IN 2358 02:00:48,880 --> 02:00:50,120 TERMS OF FINALIZING ENROLLMENT, 2359 02:00:50,120 --> 02:00:55,520 WE THINK THE RESULTS OF THIS 2360 02:00:55,520 --> 02:00:59,400 TRIAL WILL SHED IMPORTANT LIGHT 2361 02:00:59,400 --> 02:01:01,880 ON CLINICAL STRATEGIES TO 2362 02:01:01,880 --> 02:01:04,440 OUTCOMES AND PROTECT 2363 02:01:04,440 --> 02:01:07,160 PARTICIPANTS WITH WEIGHT GAIN 2364 02:01:07,160 --> 02:01:10,320 ASSOCIATED WITH THE INHIBITERS 2365 02:01:10,320 --> 02:01:13,840 AND TRF. 2366 02:01:13,840 --> 02:01:15,480 SO BEYOND THIS THOUGH THE TRIALS 2367 02:01:15,480 --> 02:01:17,960 I PRESENTED ARE FAIRLY RANGE 2368 02:01:17,960 --> 02:01:20,080 FROM PHASE 1 TO PHASE 4 CLINICAL 2369 02:01:20,080 --> 02:01:23,760 TRIALS, THERE'S ALSO A NUMBER OF 2370 02:01:23,760 --> 02:01:25,680 REALLY IMPORTANT MECHANISTIC 2371 02:01:25,680 --> 02:01:28,080 CONCEPTS THAT ARE BEING 2372 02:01:28,080 --> 02:01:29,600 DEVELOPED IN THE HIV CURE AND 2373 02:01:29,600 --> 02:01:31,240 REMISSION FIELD. 2374 02:01:31,240 --> 02:01:32,720 TO SUPPORT THE POSSIBILITY OF 2375 02:01:32,720 --> 02:01:35,440 RAPIDLY ADVANCING THESE CONCEPTS 2376 02:01:35,440 --> 02:01:39,880 INTO A CLINICAL TRIAL WITHOUT 2377 02:01:39,880 --> 02:01:42,080 THE DIFFICULTIES ASSOCIATED WITH 2378 02:01:42,080 --> 02:01:43,680 INVESTIGATOR INITIATED GRANTS, 2379 02:01:43,680 --> 02:01:51,480 WE'RE PARTNERING WITH THE ACTG 2380 02:01:51,480 --> 02:01:54,200 AND THEY STARTED A NEW SMALL 2381 02:01:54,200 --> 02:01:56,200 CLINICAL TRIALS UNIT WHEREBY 2382 02:01:56,200 --> 02:01:58,320 THEY'LL ACCEPT PROPOSALS AND 2383 02:01:58,320 --> 02:02:00,880 APPLICATIONS FOR THE SMALL 2384 02:02:00,880 --> 02:02:02,000 CLINICAL TRIALS IN HIV. 2385 02:02:02,000 --> 02:02:05,120 THE RFA IS RUN THROUGH THE ACTG 2386 02:02:05,120 --> 02:02:07,560 AND THEY'LL ACCEPT APPLICATIONS 2387 02:02:07,560 --> 02:02:08,640 TWICE A YEAR AND THOSE ARE 2388 02:02:08,640 --> 02:02:11,040 REVIEWED AND FUNDED AND THE 2389 02:02:11,040 --> 02:02:15,000 TRIALS IMPLEMENTED MUCH MORE 2390 02:02:15,000 --> 02:02:16,160 QUICKLY UTILIZING THE BACKBONE 2391 02:02:16,160 --> 02:02:27,440 AND INFRASTRUCTURE OF THE ACTG. 2392 02:02:27,440 --> 02:02:29,480 OBVIOUSLY, WE'RE NOT ONLY 2393 02:02:29,480 --> 02:02:31,680 INTERESTED IN CURE BY ALSO 2394 02:02:31,680 --> 02:02:34,480 ENDING THE HIV EPIDEMIC AS 2395 02:02:34,480 --> 02:02:37,040 DISCUSSED BY DR. DIEFFENBACH AND 2396 02:02:37,040 --> 02:02:39,960 DR. FINZI AND WE'RE CONTRIBUTING 2397 02:02:39,960 --> 02:02:40,320 EFFORT. 2398 02:02:40,320 --> 02:02:46,360 WE COLLABORATED WITH NIDA AND 2399 02:02:46,360 --> 02:02:54,360 NIMH TO PUT OUT AN APPROACH TO 2400 02:02:54,360 --> 02:02:56,480 ENDING THE HIV EPIDEMIC. 2401 02:02:56,480 --> 02:02:58,760 THE FOA IS CURRENTLY CLOSED AND 2402 02:02:58,760 --> 02:02:59,480 WE'RE EVALUATING OUR 2403 02:02:59,480 --> 02:03:01,440 POSSIBILITIES OF FUNDING THE TOP 2404 02:03:01,440 --> 02:03:02,280 SCORING APPLICATIONS AS WE 2405 02:03:02,280 --> 02:03:09,320 SPEAK. 2406 02:03:09,320 --> 02:03:14,480 BEYOND THAT DR. DIEFFENBACH 2407 02:03:14,480 --> 02:03:16,880 SHARED DETAILS ABOUT UTILIZING 2408 02:03:16,880 --> 02:03:18,600 THE SPIR MECHANISM TO ADVANCE 2409 02:03:18,600 --> 02:03:26,960 AND FOSTER THE DEVELOPMENT OF 2410 02:03:26,960 --> 02:03:27,840 NOVEL POINT OF CARE ASSAYS 2411 02:03:27,840 --> 02:03:30,360 INCLUDING TESTING FOR RESISTANCE 2412 02:03:30,360 --> 02:03:34,280 AND DRUG MONITORING AND 2413 02:03:34,280 --> 02:03:41,160 PHARMACOLOGIC ADHERENCE. 2414 02:03:41,160 --> 02:03:47,120 AS I STATED EARLIER, WE BELIEVE 2415 02:03:47,120 --> 02:03:48,440 RESEARCH ON HIV COMORBIDITIES 2416 02:03:48,440 --> 02:03:50,280 HAVE A SIGNIFICANT IMPACT ON THE 2417 02:03:50,280 --> 02:03:52,520 HEALTH OUTCOMES OF PERSONS WITH 2418 02:03:52,520 --> 02:03:56,080 HIV AND WE REALLY WORKED WITH 2419 02:03:56,080 --> 02:03:57,400 OTHER I.C.s TO DEVELOP 2420 02:03:57,400 --> 02:03:59,880 COLLABORATIONS THAT WOULD IN 2421 02:03:59,880 --> 02:04:00,200 BENEFICIAL. 2422 02:04:00,200 --> 02:04:01,360 AS YOU CAN SEE WE HAVE A 2423 02:04:01,360 --> 02:04:03,320 NATIONAL OF COLLABORATIONS WE 2424 02:04:03,320 --> 02:04:06,720 HAVE ADVANCED IN THE PAST AND WE 2425 02:04:06,720 --> 02:04:08,880 CONTINUE TO DISCUSS WITH OTHER 2426 02:04:08,880 --> 02:04:13,320 I.C.s, INSTITUTES, DIVISIONS AND 2427 02:04:13,320 --> 02:04:15,080 OTHER ORGANIZATIONS TO ADVANCE 2428 02:04:15,080 --> 02:04:16,600 POSITIVE COLLABORATIONS TOWARDS 2429 02:04:16,600 --> 02:04:17,720 THIS EFFORT. 2430 02:04:17,720 --> 02:04:21,040 WE THINK THIS IS AN IMPORTANT 2431 02:04:21,040 --> 02:04:24,680 WAY OF ADVANCING THE SCIENCE, 2432 02:04:24,680 --> 02:04:26,120 NOT ONLY ARE FUNDS LIMITED BUT 2433 02:04:26,120 --> 02:04:27,880 THE LEVEL OF EXPERTISE IS 2434 02:04:27,880 --> 02:04:30,280 LIMITED AND COUNTING ON THE 2435 02:04:30,280 --> 02:04:31,960 EXPERTISE OF OUR COLLEAGUES 2436 02:04:31,960 --> 02:04:40,040 ACROSS THE NIH IS IMPORTANT IN 2437 02:04:40,040 --> 02:04:42,600 ADVANCING THIS FIELD. 2438 02:04:42,600 --> 02:04:46,200 IN THE AREA OF TUBERCULOSIS 2439 02:04:46,200 --> 02:04:50,280 WE'RE LOOKING AT NEW DIAGNOSTICS 2440 02:04:50,280 --> 02:04:52,280 AND TREATMENTS AND VACCINES 2441 02:04:52,280 --> 02:04:53,280 THROUGH CLINICAL AND 2442 02:04:53,280 --> 02:04:54,800 OBSERVATIONAL RESEARCH IN OTHER 2443 02:04:54,800 --> 02:04:58,960 REGIONS BUT ALSO THROUGH THE 2444 02:04:58,960 --> 02:05:04,240 DEVELOPMENT OF FOAs AND RO1s TO 2445 02:05:04,240 --> 02:05:05,840 LOOK AT THE PATHOGENESIS OF T.B. 2446 02:05:05,840 --> 02:05:18,200 AND HIV. 2447 02:05:18,200 --> 02:05:22,760 PEOPLE WITH HIV ARE 15 TO 20 2448 02:05:22,760 --> 02:05:27,160 TIMES MORE LIKELY TO FALL ILL 2449 02:05:27,160 --> 02:05:29,520 WITH T.B. WITH GREATER FATALITY 2450 02:05:29,520 --> 02:05:31,000 RATES AND WHAT'S CONCERNING TO 2451 02:05:31,000 --> 02:05:34,280 MANY IN THE FIELD IS THE RATE OF 2452 02:05:34,280 --> 02:05:37,080 DRUG RESISTANCE IN T.B. IS 2453 02:05:37,080 --> 02:05:38,280 DECREASING AND THAT'S HIGHER IN 2454 02:05:38,280 --> 02:05:41,400 THE HIV INFECTED POPULATIONS 2455 02:05:41,400 --> 02:05:51,440 ACROSS THE WORLD. 2456 02:05:51,440 --> 02:05:58,280 THE T.B. PIPELINE IS THE MOST 2457 02:05:58,280 --> 02:06:00,280 ROBUST AND THERE'S A NUMBER OF 2458 02:06:00,280 --> 02:06:03,200 AGENTS NOT ONLY THE PRE-CLINICAL 2459 02:06:03,200 --> 02:06:05,320 DEVELOPMENT STAGE AND IN PHASE 2460 02:06:05,320 --> 02:06:12,520 1, 2 AND 3 CLINICAL DEVELOPMENT. 2461 02:06:12,520 --> 02:06:17,200 AND AS THE CLINICIANS KNOW IT'S 2462 02:06:17,200 --> 02:06:19,960 NOT A SINGLE TREATMENT, SINGLE 2463 02:06:19,960 --> 02:06:21,920 DRUG TYPE TREATMENT BUT SIMILAR 2464 02:06:21,920 --> 02:06:24,240 TO HIV AND REQUIRES COMBINATION 2465 02:06:24,240 --> 02:06:24,520 APPROACHES. 2466 02:06:24,520 --> 02:06:28,600 TWO OF THE MOST PROMISING NEW 2467 02:06:28,600 --> 02:06:30,280 DRUGS ON THE MARKET ARE THESE 2468 02:06:30,280 --> 02:06:32,840 TWO AND THEY BOTH PROLONG THE 2469 02:06:32,840 --> 02:06:34,960 QTC INTERVAL SO IT WAS IMPORTANT 2470 02:06:34,960 --> 02:06:36,680 TO IDENTIFY WHETHER THE 2471 02:06:36,680 --> 02:06:39,840 COMBINATION OF THESE TWO 2472 02:06:39,840 --> 02:06:40,920 TREATMENTS WOULD BE SAFE FOR 2473 02:06:40,920 --> 02:06:42,080 PARTICIPANTS TO USE FOR THE 2474 02:06:42,080 --> 02:06:43,360 TREATMENT OF T.B. 2475 02:06:43,360 --> 02:06:49,200 SO THE ACTG UNDERTOOK CLINICAL 2476 02:06:49,200 --> 02:06:51,440 TRIAL TO LOOK AT THE 2477 02:06:51,440 --> 02:06:52,720 PROLONGATION IN THIS POPULATION. 2478 02:06:52,720 --> 02:06:55,440 FOR THELY THEY FOUND WHILE THERE 2479 02:06:55,440 --> 02:07:04,480 IS ADDITIVE QTC PROLONGATION THE 2480 02:07:04,480 --> 02:07:11,320 COMBINATION WAS SAFE AND THE 2481 02:07:11,320 --> 02:07:12,840 PROLONGATION DID NOT GO BEYOND 2482 02:07:12,840 --> 02:07:15,000 FOR THE TREATMENT OF PATIENTS 2483 02:07:15,000 --> 02:07:26,320 WITH NORMAL BASELINE QT. 2484 02:07:26,320 --> 02:07:28,440 THERE'S POTENTIAL REGIMENTS THAT 2485 02:07:28,440 --> 02:07:34,280 CAN BE DEVELOPED WITH DRUGS IN 2486 02:07:34,280 --> 02:07:42,400 THE PIPELINE AND WE ARE TESTING 2487 02:07:42,400 --> 02:07:45,800 REGIMENTS IN PARALLEL WITH THE 2488 02:07:45,800 --> 02:07:47,800 IDEA THAT THOSE REG I AMS WITH 2489 02:07:47,800 --> 02:07:51,600 THE GREATEST -- REGIMENTS WITH 2490 02:07:51,600 --> 02:07:57,280 THE GREATEST EFFICACY WOULD BE 2491 02:07:57,280 --> 02:07:57,840 MOVED TO PHASE 3 CLINICAL 2492 02:07:57,840 --> 02:08:00,440 TRIALS. 2493 02:08:00,440 --> 02:08:02,480 AND IN THE FIELD OF HEPATITIS, 2494 02:08:02,480 --> 02:08:04,280 WE'RE LOOKING FOR NOVEL 2495 02:08:04,280 --> 02:08:08,240 TREATMENTS FOR HEPATITIS B CURE 2496 02:08:08,240 --> 02:08:11,600 AND VACCINES FOR PERSONS LIVING 2497 02:08:11,600 --> 02:08:13,680 WITH HIV. 2498 02:08:13,680 --> 02:08:14,320 TREATMENT SIMPLIFICATION FOR 2499 02:08:14,320 --> 02:08:20,600 LONG ACTING TREATMENTS FOR 2500 02:08:20,600 --> 02:08:23,080 HEPATITIS B AND C AND 2501 02:08:23,080 --> 02:08:24,320 DIAGNOSTICS FOR HEPATITIS B AND 2502 02:08:24,320 --> 02:08:26,200 C. 2503 02:08:26,200 --> 02:08:28,640 I THINK MOST PEOPLE KNOW THAT 2504 02:08:28,640 --> 02:08:30,040 T.B. IS THE LEADING CAUSE OF 2505 02:08:30,040 --> 02:08:31,880 MORBIDITY AND MORTALITY IN 2506 02:08:31,880 --> 02:08:35,360 PERSONS WITH HIV, HEPATITIS B 2507 02:08:35,360 --> 02:08:37,560 AND C ARE THE SECOND MOST 2508 02:08:37,560 --> 02:08:42,280 IMPORTANT CAUSE OF MORBIDITY AND 2509 02:08:42,280 --> 02:08:44,680 MORTALITY IN PERSONS LIVING WITH 2510 02:08:44,680 --> 02:08:50,680 HIV WITH MUCH OF THE BURDEN WITH 2511 02:08:50,680 --> 02:08:54,040 PERSONS IN SUB-SAHARAN AFRICA. 2512 02:08:54,040 --> 02:09:01,880 THERE'S A CLINIC STUDY 5379 TEST 2513 02:09:01,880 --> 02:09:04,440 NEW VACCINE AND OBJECTIVES IS TO 2514 02:09:04,440 --> 02:09:08,160 COMPARE THE RESPONSE OF A 2515 02:09:08,160 --> 02:09:09,480 TWO-DOSE REGIMENT OF THIS VERSUS 2516 02:09:09,480 --> 02:09:16,160 THE STANDARD THREE-DOSE REGIMENT 2517 02:09:16,160 --> 02:09:20,680 AND PERSONS WITH HIV AND 2518 02:09:20,680 --> 02:09:22,000 COMPARING THE THREE-DOSE 2519 02:09:22,000 --> 02:09:24,920 REGIMENT VERSUS THE STANDARD 2520 02:09:24,920 --> 02:09:27,080 THREE-DOSE REGIMENT IN THE SAME 2521 02:09:27,080 --> 02:09:29,920 POPULATION AND LASTLY TO 2522 02:09:29,920 --> 02:09:33,440 DETERMINE THE SPIR OF THE 2523 02:09:33,440 --> 02:09:34,800 THREE-DOSE REGIMENT IN THE 2524 02:09:34,800 --> 02:09:37,280 VACCINE NAIVE PERSONS WITH HIV. 2525 02:09:37,280 --> 02:09:39,760 IT'S A PHASE 3/4 STUDY AND 2526 02:09:39,760 --> 02:09:42,720 BELIEVE IN WORKING WITH THE 2527 02:09:42,720 --> 02:09:46,280 COMPANY THIS TRIAL COULD POSE 2528 02:09:46,280 --> 02:09:48,680 IMPORTANT DATA TO IMPROVE 2529 02:09:48,680 --> 02:09:49,480 VACCINES OF PERSONS LIVING WITH 2530 02:09:49,480 --> 02:10:00,880 HIV. 2531 02:10:00,880 --> 02:10:03,720 IN TERMS OF HEPATITIS B CURE WE 2532 02:10:03,720 --> 02:10:04,880 BELIEVE THERE'S A LOT OF WORK 2533 02:10:04,880 --> 02:10:08,680 THAT NEEDS TO HAPPEN IN THE 2534 02:10:08,680 --> 02:10:10,160 CO-INFECTION SPACE AND THE 2535 02:10:10,160 --> 02:10:12,520 DEVELOPMENT OF NEW THERAPEUTICS 2536 02:10:12,520 --> 02:10:15,360 AND DIAGNOSTICS TO NOT ONLY HELP 2537 02:10:15,360 --> 02:10:16,400 OUR CLINICAL TRIAL EFFORTS AND 2538 02:10:16,400 --> 02:10:18,280 USED CLINICALLY TO BETTER 2539 02:10:18,280 --> 02:10:22,360 IDENTIFY AND TREAT PATIENTS WITH 2540 02:10:22,360 --> 02:10:29,760 HPV AND HIV CO-INFECTION. 2541 02:10:29,760 --> 02:10:32,640 IN THE SARS COV2 FRONT, OUR 2542 02:10:32,640 --> 02:10:33,880 PROGRAM IN COLLABORATION WITH 2543 02:10:33,880 --> 02:10:38,280 THE ACTG HAS BEEN HARD AT WORK 2544 02:10:38,280 --> 02:10:41,280 DEVELOPING NOVEL TREATMENTS FOR 2545 02:10:41,280 --> 02:10:42,800 EARLY COVID-19. 2546 02:10:42,800 --> 02:10:47,080 WHAT STARTED OUT AS ONE SINGLE 2547 02:10:47,080 --> 02:10:48,520 STUDY CALLED ACTIV 2 HAS GROWN 2548 02:10:48,520 --> 02:10:51,200 TO A FAMILY OF STUDIES THAT WE 2549 02:10:51,200 --> 02:10:55,720 CALL ACTIV 2X. 2550 02:10:55,720 --> 02:11:01,720 THEY GO BY THE NAME ACTIV 2 AND 2551 02:11:01,720 --> 02:11:04,480 OTHERS AND WE'VE BEEN SUCCESSFUL 2552 02:11:04,480 --> 02:11:07,640 IN A YEAR AND A HALF WE'VE BEEN 2553 02:11:07,640 --> 02:11:11,040 ABLE TO EVALUATE OVER 10 AGENTS 2554 02:11:11,040 --> 02:11:14,280 IN THE PHASE 2 CATEGORY STUDY 2555 02:11:14,280 --> 02:11:16,280 CATEGORY AND THEN ALSO PROGRESS 2556 02:11:16,280 --> 02:11:18,960 SOME OF THEM INTO PHASE 3 AS 2557 02:11:18,960 --> 02:11:23,920 DR. DIEFFENBACH NOTED, WE HAVE 2558 02:11:23,920 --> 02:11:25,480 FINISHED PRELIMINARY EVALUATION 2559 02:11:25,480 --> 02:11:28,360 OF THE MONOCLONAL ANTIBODIES 2560 02:11:28,360 --> 02:11:30,040 SUBMITTED FOR AN EUA 2561 02:11:30,040 --> 02:11:31,600 CONSIDERATION. 2562 02:11:31,600 --> 02:11:35,160 WE'RE ACTIVELY ENROLLING INTO A 2563 02:11:35,160 --> 02:11:39,720 PHASE 3 OF THE POLY CLONAL 2564 02:11:39,720 --> 02:11:42,840 ANTIBODIES AND HAVE SEVERAL 2565 02:11:42,840 --> 02:11:47,480 AGENTS AND A PROTEASE INHIBITER 2566 02:11:47,480 --> 02:11:49,400 AND A COUPLE OF OTHERS EARLIER 2567 02:11:49,400 --> 02:11:51,960 PHASED AGENTS WAITING IN THE 2568 02:11:51,960 --> 02:11:54,680 WINGS TO GET STARTED IN PHASE 3 2569 02:11:54,680 --> 02:12:07,320 EVALUATION. 2570 02:12:07,320 --> 02:12:08,640 WE WERE ABLE TO LOOK AT THIS 2571 02:12:08,640 --> 02:12:11,760 PHASE 3 STUDY AND FOUND THE 2572 02:12:11,760 --> 02:12:13,200 COMBINATION ANTIBODIES WERE 2573 02:12:13,200 --> 02:12:16,280 HIGHLY EFFECTIVE IN REDUCING THE 2574 02:12:16,280 --> 02:12:17,600 RISK OF HOSPITALIZATION AND 2575 02:12:17,600 --> 02:12:19,520 DEATH WITH A 78% REDUCTION IN 2576 02:12:19,520 --> 02:12:19,920 RISK. 2577 02:12:19,920 --> 02:12:24,680 WE ALSO FOUND TREATMENT WITHIN 2578 02:12:24,680 --> 02:12:27,920 THE FIRST FIVE DAYS SHOWED 2579 02:12:27,920 --> 02:12:28,880 SIMILAR EFFICACY EVEN AS 2580 02:12:28,880 --> 02:12:31,080 TREATMENT FROM SIX TO 10 DAYS 2581 02:12:31,080 --> 02:12:33,560 FROM SYSTEM ONSET WHICH IS WE 2582 02:12:33,560 --> 02:12:35,040 BELIEVE A VERY IMPORTANT FINDING 2583 02:12:35,040 --> 02:12:38,320 ESPECIALLY GIVEN THE FACT THAT 2584 02:12:38,320 --> 02:12:39,880 SOMETIMES A DIAGNOSIS OF 2585 02:12:39,880 --> 02:12:42,160 PATIENTS WITH COVID-19 CAN BE 2586 02:12:42,160 --> 02:12:44,680 DELAYED DUE TO DIFFICULTY EITHER 2587 02:12:44,680 --> 02:12:45,720 FINDING A DIAGNOSTIC TEST OR 2588 02:12:45,720 --> 02:12:50,280 GETTING THE RESULTS BACK FROM 2589 02:12:50,280 --> 02:12:52,920 THE LAB. 2590 02:12:52,920 --> 02:12:54,480 SO I'LL END THERE. 2591 02:12:54,480 --> 02:12:59,320 I APOLOGIZE AGAIN FOR THE CHOPPY 2592 02:12:59,320 --> 02:13:00,880 PRESENTATION DUE TO THE INTERNET 2593 02:13:00,880 --> 02:13:01,080 LAG. 2594 02:13:01,080 --> 02:13:04,320 I WOULD LIKE TO ACKNOWLEDGE THE 2595 02:13:04,320 --> 02:13:07,040 MANY PEOPLE WHO ARE IN TRP THAT 2596 02:13:07,040 --> 02:13:07,640 CONTRIBUTE TO THIS WORK. 2597 02:13:07,640 --> 02:13:09,480 THEY'VE DONE A TREMENDOUS JOB IN 2598 02:13:09,480 --> 02:13:13,440 NOT ONLY KEEPING THE SCIENCE OF 2599 02:13:13,440 --> 02:13:16,000 HIV, T.B. AND HEPATITIS MOVING 2600 02:13:16,000 --> 02:13:18,880 FORWARD AND CONTRIBUTING TO THE 2601 02:13:18,880 --> 02:13:19,520 OVERALL U.S. GOVERNMENT COVID-19 2602 02:13:19,520 --> 02:13:22,840 EFFORTS. 2603 02:13:22,840 --> 02:13:25,240 >> THANK YOU FOR THE GREAT 2604 02:13:25,240 --> 02:13:25,680 OVERVIEW. 2605 02:13:25,680 --> 02:13:26,960 A LOT OF ACTIVITY. 2606 02:13:26,960 --> 02:13:28,360 EXCITING ACTIVITY. 2607 02:13:28,360 --> 02:13:31,240 MAYBE WE COULD MAKE ONE QUESTION 2608 02:13:31,240 --> 02:13:34,280 IF ANYONE HAS A BRIEF QUESTION 2609 02:13:34,280 --> 02:13:44,560 FOR PETER. 2610 02:13:44,560 --> 02:13:45,600 WE'VE ALL BEEN IMPRESSED WITH 2611 02:13:45,600 --> 02:13:47,840 THE ACTIVE STUDIES. 2612 02:13:47,840 --> 02:13:49,840 IT'S BEEN FANTASTIC. 2613 02:13:49,840 --> 02:13:50,280 THANK YOU. 2614 02:13:50,280 --> 02:13:50,840 ALL RIGHT. 2615 02:13:50,840 --> 02:13:53,000 WHY DON'T WE MOVE ON TO THE 2616 02:13:53,000 --> 02:13:56,760 PREVENTION SCIENCES PROGRAM. 2617 02:13:56,760 --> 02:14:12,400 AND LOOK FORWARD TO SHERYL 2618 02:14:12,400 --> 02:14:13,000 ZWERSKI'S PRESENTATION. 2619 02:14:13,000 --> 02:14:15,600 >> GOOD AFTERNOON. 2620 02:14:15,600 --> 02:14:17,080 I'M EXCITED TO PRESENT TO YOU 2621 02:14:17,080 --> 02:14:22,280 THE PREVENTION SCIENCES PROGRAM 2622 02:14:22,280 --> 02:14:30,840 OVERVIEW AND UPDATE. 2623 02:14:30,840 --> 02:14:32,680 WE'LL DO A BIT OF BACKGROUND AND 2624 02:14:32,680 --> 02:14:38,200 THEN TALK ABOUT TRANSITIONS AND 2625 02:14:38,200 --> 02:14:40,040 CHANGES IN THE PROGRAM SOME 2626 02:14:40,040 --> 02:14:41,480 HIGHLIGHTS OF WHAT'S UP NEXT FOR 2627 02:14:41,480 --> 02:14:44,480 US, WHAT WE SEE AS SOME OF THE 2628 02:14:44,480 --> 02:14:47,000 HIGH LEVEL CHALLENGES AND 2629 02:14:47,000 --> 02:14:49,120 OPPORTUNITIES AND THEN OF COURSE 2630 02:14:49,120 --> 02:14:55,960 IF TIME PERMITS, QUESTIONS. 2631 02:14:55,960 --> 02:14:57,840 EVERYONE IS AWARE OF THIS AND 2632 02:14:57,840 --> 02:14:59,080 THOUGHT IT WAS IMPORTANT TO SET 2633 02:14:59,080 --> 02:15:01,800 THE STAGE TO REMIND EVERYONE WE 2634 02:15:01,800 --> 02:15:05,640 HAVE JUST UNDER 38 MILLION 2635 02:15:05,640 --> 02:15:08,400 PEOPLE LIVING WITH HIV, 1.7 2636 02:15:08,400 --> 02:15:12,640 MILLION OF THOSE WILL CHILDREN. 2637 02:15:12,640 --> 02:15:16,200 AND THEN 1.5 MILLION PEOPLE 2638 02:15:16,200 --> 02:15:17,320 NEWLY INFECTED AND 150,000 OF 2639 02:15:17,320 --> 02:15:18,480 THOSE ARE CHILDREN UNDER THE AGE 2640 02:15:18,480 --> 02:15:28,000 OF 15 YEARS. 2641 02:15:28,000 --> 02:15:29,680 ALSO AND NO SURPRISE TO ANYONE 2642 02:15:29,680 --> 02:15:33,240 WE CERTAINLY DID NOT ACHIEVE THE 2643 02:15:33,240 --> 02:15:41,880 2020 PREVENTION TARGET. 2644 02:15:41,880 --> 02:15:44,880 BE A CHALLENGE TO MEET THE 2025 2645 02:15:44,880 --> 02:15:46,200 TARGET BUT WE'RE HOPING WITH 2646 02:15:46,200 --> 02:15:51,760 SOME OF THE NEW PREPAREER 2647 02:15:51,760 --> 02:15:59,880 SOME OF THE NEW PREPARE EER PREVENTION 2648 02:15:59,880 --> 02:16:00,720 PROJECTS WE CAN MAKE PROGRESS. 2649 02:16:00,720 --> 02:16:02,000 AND TO REMIND EVERYONE OF HOW 2650 02:16:02,000 --> 02:16:04,440 PERSON IT IS TO KEEP THINKING 2651 02:16:04,440 --> 02:16:10,040 ABOUT KEY POPULATIONS AT RISK 2652 02:16:10,040 --> 02:16:15,080 FOR HIV. 2653 02:16:15,080 --> 02:16:18,680 AND FOCUSSING AND DEVELOPING 2654 02:16:18,680 --> 02:16:19,480 PREVENTIONS AND STRATEGIES FOR 2655 02:16:19,480 --> 02:16:30,440 THESE POPULATIONS. 2656 02:16:30,440 --> 02:16:31,480 THERE'S KEY CHANGES THAT HAVE 2657 02:16:31,480 --> 02:16:42,480 OCCURRED IN THE PAST YEAR. 2658 02:16:42,480 --> 02:16:46,280 AND I DID WANT TO POINT OUT 2659 02:16:46,280 --> 02:16:50,920 THERE WERE THREE REQUIREMENTS 2660 02:16:50,920 --> 02:16:56,280 THAT OCCURRED IN THE PAST YEAR 2661 02:16:56,280 --> 02:16:57,160 THAT HAVE MEANT IMPORTANT 2662 02:16:57,160 --> 02:16:58,280 CHANGES TO THE PROGRAM. 2663 02:16:58,280 --> 02:17:03,560 MOST KNOW THE LONG STANDING 2664 02:17:03,560 --> 02:17:04,960 BRANCH CHIEF FOR THE PRECLINICAL 2665 02:17:04,960 --> 02:17:06,280 BRANCH AND IN THE LAST COUPLE 2666 02:17:06,280 --> 02:17:10,320 YEARS HE HAD SERVED AS THE 2667 02:17:10,320 --> 02:17:11,040 ACTING DEPUTY DIRECTOR FOR THE 2668 02:17:11,040 --> 02:17:18,840 PROGRAM OVERALL. 2669 02:17:18,840 --> 02:17:34,440 HE RETIRED IN 2021 WE HAVE A NEW 2670 02:17:34,440 --> 02:17:34,680 DIRECTOR. 2671 02:17:34,680 --> 02:17:37,880 JAMES CUMMINS STEPPED IN FOR THE 2672 02:17:37,880 --> 02:17:41,840 PRE CLINICAL BRANCH AND WE HAD 2673 02:17:41,840 --> 02:17:44,680 DAVID BYRNES RETIRED WHO HAD 2674 02:17:44,680 --> 02:17:47,280 BEEN A LONG TIME BRANCH CHIEF 2675 02:17:47,280 --> 02:17:52,440 FOR THE CLINICAL PREVENTION 2676 02:17:52,440 --> 02:17:53,920 BRANCH AND WE HAVE A BRANCH 2677 02:17:53,920 --> 02:17:56,480 CHIEF FOR THE BRANCH AND 2678 02:17:56,480 --> 02:17:57,720 DR. TORRES WHO HAS BEEN WORKING 2679 02:17:57,720 --> 02:18:04,360 AND CONTINUES TO WORK ON SOME OF 2680 02:18:04,360 --> 02:18:12,000 THE MICROBICIDE WORK. 2681 02:18:12,000 --> 02:18:17,440 WE ALSO HAD A LONG-TIME STAFF 2682 02:18:17,440 --> 02:18:19,480 MEMBER AND IMPORTANT LEADER IN 2683 02:18:19,480 --> 02:18:21,800 THE PRECLINICAL BRANCH RETIRED 2684 02:18:21,800 --> 02:18:22,840 FROM FEDERAL SERVICE A COUPLE 2685 02:18:22,840 --> 02:18:26,320 YEARS AGO BUT THEN HAD BEEN 2686 02:18:26,320 --> 02:18:28,440 PART-TIME CONTRACTOR WITH US. 2687 02:18:28,440 --> 02:18:31,760 SHE ALSO OFFICIALLY COMPLETELY 2688 02:18:31,760 --> 02:18:32,240 REQUIRED. 2689 02:18:32,240 --> 02:18:48,280 WE HAD MIKE GILBRITH RETIRE AND 2690 02:18:48,280 --> 02:18:50,280 ROBERTA BLACK AND JUDY MILLER 2691 02:18:50,280 --> 02:18:51,080 HAVE TAKEN OVER. 2692 02:18:51,080 --> 02:19:06,280 I WANT TO TAKE A MOMENT AND TAKE 2693 02:19:06,280 --> 02:19:13,360 AND WANT TO THANK THOSE FOR THE 2694 02:19:13,360 --> 02:19:22,320 PRESENTATION FOR THIS AND JUST 2695 02:19:22,320 --> 02:19:25,400 AS A REMINDER OF OUR HIGH LEVEL 2696 02:19:25,400 --> 02:19:27,080 PRIORITIES AND YOU CAN SEE 2697 02:19:27,080 --> 02:19:29,120 THEY'RE DIVIDE INTO TWO MAJOR 2698 02:19:29,120 --> 02:19:31,960 AREAS AND THAT WILL BE HOW I 2699 02:19:31,960 --> 02:19:34,320 APPROACH SOME OF THE 2700 02:19:34,320 --> 02:19:37,360 ACCOMPLISHMENTS AS WELL AS THE 2701 02:19:37,360 --> 02:19:39,320 WAY FORWARD AS A REMINDER, 2702 02:19:39,320 --> 02:19:41,600 DEVELOPMENT OF HIV PREVENTION 2703 02:19:41,600 --> 02:19:43,440 PRODUCTS AND THE ATTENDANT 2704 02:19:43,440 --> 02:19:46,680 PIECES AND ISSUES THAT GO WITH 2705 02:19:46,680 --> 02:19:49,680 THAT CONTINUING TO FURTHER OUR 2706 02:19:49,680 --> 02:19:51,840 UNDERSTANDING OF THE BIOLOGY OF 2707 02:19:51,840 --> 02:19:53,080 HIV SUSCEPTIBILITY WHICH 2708 02:19:53,080 --> 02:19:55,480 HOPEFULLY DOES HELP US IN THE 2709 02:19:55,480 --> 02:19:57,880 DEVELOPMENT OF NEW PREVENTION 2710 02:19:57,880 --> 02:19:58,280 PRODUCTS. 2711 02:19:58,280 --> 02:20:01,080 IMPROVE ENGAGEMENT OF KEY 2712 02:20:01,080 --> 02:20:03,240 POPULATIONS AS I TALKED ABOUT 2713 02:20:03,240 --> 02:20:06,280 WITH THE SLIDE EARLIER AND AS WE 2714 02:20:06,280 --> 02:20:09,280 ALL KNOW THAT IS REALLY VERY 2715 02:20:09,280 --> 02:20:11,160 MUCH A CHALLENGE AND SOMETHING 2716 02:20:11,160 --> 02:20:13,400 THAT WE RECOGNIZE BUT REALLY 2717 02:20:13,400 --> 02:20:15,680 NEED TO DO IN PARTNERSHIP WITH 2718 02:20:15,680 --> 02:20:20,560 OTHER USG AGENCIES INCLUDING 2719 02:20:20,560 --> 02:20:24,520 C.D.C. AS WELL AS OTHERS. 2720 02:20:24,520 --> 02:20:26,520 AND THEN THINKING ABOUT THE 2721 02:20:26,520 --> 02:20:29,880 AREAS OF MATERNAL AND CHILD 2722 02:20:29,880 --> 02:20:32,600 TREATMENT T.B. AND CURE WHERE 2723 02:20:32,600 --> 02:20:36,480 ONE OF OUR MAJOR PRIORITIES IS 2724 02:20:36,480 --> 02:20:38,880 TO IMPROVE HIV TREATMENT AND 2725 02:20:38,880 --> 02:20:41,280 PREVENTION IN BOTH PREGNANT 2726 02:20:41,280 --> 02:20:42,680 WOMEN AND CHILDREN. 2727 02:20:42,680 --> 02:20:46,200 ALSO TO OPTIMIZE STRATEGIES TO 2728 02:20:46,200 --> 02:20:48,640 DIAGNOSE, TREAT AND PREVENT T.B. 2729 02:20:48,640 --> 02:20:50,480 IN THE MATERNAL AND PEDIATRIC 2730 02:20:50,480 --> 02:20:52,240 POPULATIONS AND CONTINUE TO 2731 02:20:52,240 --> 02:20:54,240 EVOLVE THE CURE RESEARCH IN 2732 02:20:54,240 --> 02:21:01,000 INFANTS AND CHILDREN. 2733 02:21:01,000 --> 02:21:06,400 THIS IS TO ILLUSTRATE TO YOU ALL 2734 02:21:06,400 --> 02:21:08,200 THAT WE HAVE A NUMBER OF 2735 02:21:08,200 --> 02:21:12,840 SOLICITED PROGRAMS THAT SPAN THE 2736 02:21:12,840 --> 02:21:15,040 DEVELOPMENT CASCADE ALL THE WAY 2737 02:21:15,040 --> 02:21:16,880 FROM DISCOVERY THROUGH CLINICAL 2738 02:21:16,880 --> 02:21:17,080 STUDIES. 2739 02:21:17,080 --> 02:21:18,680 I'LL BRING YOUR ATTENTION OVER 2740 02:21:18,680 --> 02:21:19,240 TO THE FAR RIGHT. 2741 02:21:19,240 --> 02:21:22,240 THERE WE HAVE THE NETWORKS 2742 02:21:22,240 --> 02:21:29,160 LISTED AS YOU ALL KNOW WE HAVE 2743 02:21:29,160 --> 02:21:35,040 THE MICROBECIDE NETWORK AND THE 2744 02:21:35,040 --> 02:21:44,880 CRITICAL WORK HAS MOVED IN 2745 02:21:44,880 --> 02:22:00,440 DECEMBER OF THE PAST YEAR. 2746 02:22:00,440 --> 02:22:02,320 AND THIS CONTINUES TO BE OUR 2747 02:22:02,320 --> 02:22:05,480 BASE FOR GAP FILLING ACTIVITIES 2748 02:22:05,480 --> 02:22:09,640 ALONG THE SPECTRUM FROM PRE 2749 02:22:09,640 --> 02:22:11,480 CLINICAL TO CLINICAL TESTING AND 2750 02:22:11,480 --> 02:22:13,440 LOOKING FORWARD TO MOVE THE NEXT 2751 02:22:13,440 --> 02:22:17,840 ITERATION APPROVED EARLIER IN 2752 02:22:17,840 --> 02:22:32,080 THE YEAR MOVING FORWARD. 2753 02:22:32,080 --> 02:22:34,280 AND I'LL TAKE SEVERAL SELECT 2754 02:22:34,280 --> 02:22:35,080 ACCOMPLISHMENT HIGHLIGHTS FROM 2755 02:22:35,080 --> 02:22:38,040 THE DIFFERENT AREAS THAT WE WORK 2756 02:22:38,040 --> 02:22:40,160 IN AND CERTAINLY NOT MEANT TO BE 2757 02:22:40,160 --> 02:22:41,480 ALL INCLUSIVE. 2758 02:22:41,480 --> 02:22:44,040 I WANT TO BEFORE I GO INTO THIS 2759 02:22:44,040 --> 02:22:47,560 I WANT TO SAY THAT NOT ONLY IS 2760 02:22:47,560 --> 02:22:50,280 IT THE STAFF IN PREVENTION 2761 02:22:50,280 --> 02:22:51,360 SCIENCES PROGRAM THAT 2762 02:22:51,360 --> 02:22:52,880 CONTRIBUTES TO ALL OF THE WORK 2763 02:22:52,880 --> 02:22:59,240 THAT WE DO, WE REALLY ARE VERY 2764 02:22:59,240 --> 02:23:03,640 MUCH MATRIXED FOR OUR WORK 2765 02:23:03,640 --> 02:23:05,320 ACROSS OUR WHOLE DIVISION OF 2766 02:23:05,320 --> 02:23:10,280 AIDS, THE SCIENTIFIC PROGRAMS AS 2767 02:23:10,280 --> 02:23:12,800 WELL AS OUR COLLEAGUES AND 2768 02:23:12,800 --> 02:23:16,880 ACROSS VARIOUS OTHER I.C.s 2769 02:23:16,880 --> 02:23:29,160 SPECIFICALLY NIMH AND OAR AND 2770 02:23:29,160 --> 02:23:29,400 OTHERS. 2771 02:23:29,400 --> 02:23:33,680 CARL TALKED ABOUT THE APPROVAL 2772 02:23:33,680 --> 02:23:44,520 FOR LONG ACTING CABOTEGRAVIR 2773 02:23:44,520 --> 02:23:50,440 REPRESENTS WORK ACROSS OUR 2774 02:23:50,440 --> 02:23:53,120 PHARMA PARTNERS. 2775 02:23:53,120 --> 02:23:55,120 THE SECOND BULLET RECOGNIZING 2776 02:23:55,120 --> 02:23:58,680 THE ONGOING SAFETY AND P.K. 2777 02:23:58,680 --> 02:24:01,080 TRIALS WE DO IN COLLABORATION 2778 02:24:01,080 --> 02:24:02,120 WITH OUR VACCINE RESEARCH 2779 02:24:02,120 --> 02:24:04,760 PROGRAM COLLEAGUES. 2780 02:24:04,760 --> 02:24:13,080 AND THAT IS MOST OF WHICH ARE 2781 02:24:13,080 --> 02:24:14,320 COLLABORATIONS BETWEEN THE EARLY 2782 02:24:14,320 --> 02:24:16,040 STUDIES CONTRIBUTING TO OUR 2783 02:24:16,040 --> 02:24:17,560 KNOWLEDGE BASE AS TO HOW TO MOVE 2784 02:24:17,560 --> 02:24:20,600 FORWARD IN THIS AREA. 2785 02:24:20,600 --> 02:24:23,160 SOME OF THE OTHER PIECES OF 2786 02:24:23,160 --> 02:24:26,040 CRITICAL WORK THE LAST BULLET 2787 02:24:26,040 --> 02:24:30,280 HERE IS ABOUT MTNO34 WHICH WAS A 2788 02:24:30,280 --> 02:24:35,360 STUDY IN ADOLESCENCE IN YOUNG 2789 02:24:35,360 --> 02:24:37,400 WOMEN IN SOME OF THE AFRICAN 2790 02:24:37,400 --> 02:24:39,400 SITES AND IT'S SOME OF THE 2791 02:24:39,400 --> 02:24:40,480 CRITICAL BRIDGING WORK AND 2792 02:24:40,480 --> 02:24:42,640 THERE'S ACTUALLY THREE OF THOSE 2793 02:24:42,640 --> 02:24:42,880 STUDIES. 2794 02:24:42,880 --> 02:24:44,400 THE OTHER COUPLE I'LL POINT OUT 2795 02:24:44,400 --> 02:24:47,160 AS WE GO LONG BUT THIS IS THE 2796 02:24:47,160 --> 02:24:49,600 WORK -- WE GO ALONG BUT TO 2797 02:24:49,600 --> 02:24:52,600 BRIDGE THE RING INTO THE 2798 02:24:52,600 --> 02:24:53,840 IMPORTANT POPULATIONS. 2799 02:24:53,840 --> 02:24:55,680 THIS WAS REPORTED OUT THIS PAST 2800 02:24:55,680 --> 02:24:59,880 YEAR THAT THE ADHERENCE IN THIS 2801 02:24:59,880 --> 02:25:03,280 YOUNGER GROUP WAS SURPRISINGLY 2802 02:25:03,280 --> 02:25:04,760 HIGHER THAN HAD BEEN FOR 2803 02:25:04,760 --> 02:25:09,840 OBSERVED IN THE ORIGINAL TRIALS 2804 02:25:09,840 --> 02:25:11,560 SO THAT WAS INFORMATION AS WELL 2805 02:25:11,560 --> 02:25:13,680 AS OTHER LESSONS LEARNED IN HOW 2806 02:25:13,680 --> 02:25:16,440 TO BEST CONDUCT STUDIES IN 2807 02:25:16,440 --> 02:25:27,720 ADOLESCENTS FROM THIS TRIAL. 2808 02:25:27,720 --> 02:25:32,400 AND MOVING ON TO THE 100 AND 200 2809 02:25:32,400 --> 02:25:34,000 MILLIGRAM INTRAVAGINAL RING 2810 02:25:34,000 --> 02:25:35,560 COMPARED TO THE ORIGINAL RING 2811 02:25:35,560 --> 02:25:44,200 WHICH WAS THE 28 DAY, 25 MILL 2812 02:25:44,200 --> 02:25:44,520 G 2813 02:25:44,520 --> 02:25:46,040 GRAMS. 2814 02:25:46,040 --> 02:25:48,480 ALL THREE WERE WELL TOLERATED 2815 02:25:48,480 --> 02:25:51,040 AND THERE WERE HIGHER 2816 02:25:51,040 --> 02:25:51,720 CONCENTRATIONS IN TISSUE AS WELL 2817 02:25:51,720 --> 02:25:53,000 AS FLUIDS. 2818 02:25:53,000 --> 02:25:57,280 PROBABLY NOT TERRIBLY SURPRISING 2819 02:25:57,280 --> 02:25:59,560 GIVEN THEY WERE HIGHER DOSAGES 2820 02:25:59,560 --> 02:26:03,680 BUT WAS IMPORTANT FOR US TO KNOW 2821 02:26:03,680 --> 02:26:04,640 THAT INFORMATION. 2822 02:26:04,640 --> 02:26:06,480 I'LL STAY ON AND JUMP DOWN HERE 2823 02:26:06,480 --> 02:26:12,800 TO THE THIRD BULLET STAYING ON 2824 02:26:12,800 --> 02:26:18,960 THE DAPIVIRINE RING AND IT'S 2825 02:26:18,960 --> 02:26:20,480 ALSO IMPORTANT TO THE LABELLING 2826 02:26:20,480 --> 02:26:41,680 FOR THAT PRODUCT. 2827 02:26:41,680 --> 02:26:43,120 THERE'S AN AREA MANY HAVE HEARD 2828 02:26:43,120 --> 02:26:48,440 ABOUT OVER THE YEARS. 2829 02:26:48,440 --> 02:27:08,440 SEVERAL OF THOSE GRANTS AND WE 2830 02:27:08,440 --> 02:27:10,480 HEARD THE PRODUCTS AND WHAT WE 2831 02:27:10,480 --> 02:27:12,880 ARE LEARNING ABOUT THESE 2832 02:27:12,880 --> 02:27:14,320 DELIVERY SYSTEMS FOR HIV 2833 02:27:14,320 --> 02:27:16,560 PREVENTION PRODUCTS AND WE CAN 2834 02:27:16,560 --> 02:27:17,480 TAKE THAT KNOWLEDGE WITH US AS 2835 02:27:17,480 --> 02:27:34,040 WE MOVE FORWARD. 2836 02:27:34,040 --> 02:27:36,120 AND THERE'S A STAFF IN OUR GROUP 2837 02:27:36,120 --> 02:27:43,280 AND ACROSS THE DIVISION WHO 2838 02:27:43,280 --> 02:27:45,080 ORGANIZED A PREGNANCY WORKSHOP 2839 02:27:45,080 --> 02:27:46,120 TO GATHER STAKEHOLDERS TO 2840 02:27:46,120 --> 02:27:47,520 DISCUSS WHAT THE BARRIERS AND 2841 02:27:47,520 --> 02:27:50,200 CHALLENGES ARE AND SOME OF THE 2842 02:27:50,200 --> 02:27:51,080 WAYS FORWARD. 2843 02:27:51,080 --> 02:27:54,480 ALSO, FOLKS WITHIN OUR GROUP 2844 02:27:54,480 --> 02:27:57,640 PARTICIPATED IN THE W.H.O. AND 2845 02:27:57,640 --> 02:27:58,880 IMPACT CALL TO ACTION THE 2846 02:27:58,880 --> 02:28:01,600 WORKING GROUP ON ACCELERATING 2847 02:28:01,600 --> 02:28:06,280 INCLUSION OF PREGNANT WOMEN INTO 2848 02:28:06,280 --> 02:28:07,480 ANTIRETROVIRAL STUDIES AND THIS 2849 02:28:07,480 --> 02:28:09,880 IS BUILDING ON THE IMPORTANT 2850 02:28:09,880 --> 02:28:12,720 WORK FROM THE PREGLAC GROUP YOU 2851 02:28:12,720 --> 02:28:15,440 ALL ARE PROBABLY FAMILIAR WITH 2852 02:28:15,440 --> 02:28:22,080 THAT WAS LED BY NIH ACROSS USG 2853 02:28:22,080 --> 02:28:23,520 AGENCY GROUPS THAT MET FOR QUITE 2854 02:28:23,520 --> 02:28:27,840 SOME TIME AND CAME FORWARD WITH 2855 02:28:27,840 --> 02:28:29,080 RECOMMENDATIONS ABOUT RESEARCH 2856 02:28:29,080 --> 02:28:34,480 IN GENERAL IN PREGNANT WOMEN. 2857 02:28:34,480 --> 02:28:37,000 AND MOVING TO CHILDREN, THE 2858 02:28:37,000 --> 02:28:42,280 IMPACT STUDY THE P.K. DATA 2859 02:28:42,280 --> 02:28:46,280 RESULTED IN A RAPID 2860 02:28:46,280 --> 02:28:48,280 COMMUNICATION ON THE USAGE IN 2861 02:28:48,280 --> 02:28:55,520 YOUNG CHILDREN FOR MDRTB AND 2862 02:28:55,520 --> 02:28:56,640 THERE'LL BE COMMUNICATIONS 2863 02:28:56,640 --> 02:28:58,480 COMING FORWARD ON MORE SPECIFIC 2864 02:28:58,480 --> 02:29:09,200 DOSING MOVING THROUGH THIS YEAR. 2865 02:29:09,200 --> 02:29:13,880 [AUDIO DIGITIZING] 2866 02:29:13,880 --> 02:29:15,200 AND FOR THE SUBMISSION THE 2867 02:29:15,200 --> 02:29:18,280 TREATMENT FOR ADOLESCENTS AND 2868 02:29:18,280 --> 02:29:21,680 THE IMPACT 2014 FOR TREATMENT IN 2869 02:29:21,680 --> 02:29:22,320 ADOLESCENTS AS WELL. 2870 02:29:22,320 --> 02:29:24,600 WE ALSO COLLABORATED WITH OUR 2871 02:29:24,600 --> 02:29:26,680 BASIC SCIENCES PROGRAM 2872 02:29:26,680 --> 02:29:32,400 COLLEAGUES TO LAUNCH THE FIRST 2873 02:29:32,400 --> 02:29:33,280 PEDIATRIC FOCUS COLLABORATORY. 2874 02:29:33,280 --> 02:29:37,360 YOU CAN SEE THE LOGO AT THE 2875 02:29:37,360 --> 02:29:51,680 BOTTOM THE PAID COLLABORATORY. 2876 02:29:51,680 --> 02:29:53,240 AND WE'VE TALKED ABOUT THE 2877 02:29:53,240 --> 02:29:55,680 INCLUSION OF PREGNANT WOMEN 2878 02:29:55,680 --> 02:29:59,920 EARLIER IN HIV RESEARCH BOTH 2879 02:29:59,920 --> 02:30:01,480 PREVENTION AND TREATMENT AND 2880 02:30:01,480 --> 02:30:02,920 PLEAD TO REPORT THE STUDY HAS 2881 02:30:02,920 --> 02:30:06,280 THREE COHORTS WORKING BACKWARD 2882 02:30:06,280 --> 02:30:08,320 IN GESTATION STARTING IN COHORT 2883 02:30:08,320 --> 02:30:12,480 1 WITH THE WOMEN OF THE 36 TO 37 2884 02:30:12,480 --> 02:30:12,680 WEEKS. 2885 02:30:12,680 --> 02:30:26,880 THAT COHORT WAS COMPLETED. 2886 02:30:26,880 --> 02:30:32,440 IT'S LOOKING AT DAPRIVIRINE 2887 02:30:32,440 --> 02:30:34,880 INTRAVAGINAL RING AND THE ORAL 2888 02:30:34,880 --> 02:30:36,720 USAGE AND COHORT 2 IS IN 2889 02:30:36,720 --> 02:30:38,840 PROGRESS AND HOPING TO COMPLETE 2890 02:30:38,840 --> 02:30:40,000 THAT ENROLLMENT BY THE BEGINNING 2891 02:30:40,000 --> 02:30:48,240 OF MARCH. 2892 02:30:48,240 --> 02:30:53,240 I TALKED WITH THE FACT THAT THE 2893 02:30:53,240 --> 02:30:54,920 DAPRIVIRINE ARE CRITICAL 2894 02:30:54,920 --> 02:30:55,520 INFORMATION FOR THESE 2895 02:30:55,520 --> 02:31:02,240 POPULATIONS MOVING FORWARD FOR 2896 02:31:02,240 --> 02:31:04,560 APPROVALS. 2897 02:31:04,560 --> 02:31:08,480 AND AS POINTED OUT WITH THE 2898 02:31:08,480 --> 02:31:11,880 EARLIER SLIDES WE'VE MOVED INTO 2899 02:31:11,880 --> 02:31:13,800 AWAY FROM SOME TOPICAL 2900 02:31:13,800 --> 02:31:14,760 PREVENTION AND IT'S IMPORTANT WE 2901 02:31:14,760 --> 02:31:17,960 HAVE THIS INFORMATION BOTH TO 2902 02:31:17,960 --> 02:31:20,680 COMPLETE THIS WORK ON 2903 02:31:20,680 --> 02:31:23,680 DAPRIVIRINE AND ON THE DELIVERY 2904 02:31:23,680 --> 02:31:28,360 SYSTEMS THAT POINTED OUT FROM 2905 02:31:28,360 --> 02:31:30,080 OTHERS THAT INFORM PREVENTION, 2906 02:31:30,080 --> 02:31:35,760 PRODUCT DEVELOPMENT MOVING 2907 02:31:35,760 --> 02:31:40,160 FORWARD AND A LOT OF THIS 2908 02:31:40,160 --> 02:31:41,360 INFORMATION WILL BE HELPFUL AS 2909 02:31:41,360 --> 02:32:00,160 WE MOVE INTO THAT WORK. 2910 02:32:00,160 --> 02:32:04,160 AND WE LOOK AT THE MAJOR GAPS IN 2911 02:32:04,160 --> 02:32:07,240 HIV PREVENTION RESEARCH. 2912 02:32:07,240 --> 02:32:09,320 ON THE ONE HAND A LOT OF HAS 2913 02:32:09,320 --> 02:32:10,760 CHANGED IN THE PAST YEAR AS YOU 2914 02:32:10,760 --> 02:32:14,280 CAN SEE FROM IS THE SELECT 2915 02:32:14,280 --> 02:32:14,600 HIGHLIGHTS. 2916 02:32:14,600 --> 02:32:15,680 A LOT'S BEEN ACCOMPLISHED BUT WE 2917 02:32:15,680 --> 02:32:17,600 WERE ALREADY AWARE LAST YEAR OF 2918 02:32:17,600 --> 02:32:20,560 THE FACT THAT THESE WERE GOING 2919 02:32:20,560 --> 02:32:22,160 TO BE THE CHALLENGES THAT WE 2920 02:32:22,160 --> 02:32:24,240 WERE FACING. 2921 02:32:24,240 --> 02:32:27,280 AND PARTICULARLY ABOUT ADVANCING 2922 02:32:27,280 --> 02:32:30,840 AND MARY BROUGHT THIS UP IN HER 2923 02:32:30,840 --> 02:32:33,200 PRESENTATION THE CHALLENGES OF 2924 02:32:33,200 --> 02:32:35,040 ADVANCING THE NEXT GENERATION OF 2925 02:32:35,040 --> 02:32:37,480 PREVENTION PRODUCTS INTO HUMAN 2926 02:32:37,480 --> 02:32:38,760 CLINICAL TESTING AND DOING THAT 2927 02:32:38,760 --> 02:32:41,160 IN WAYS THAT GET US THE ANSWERS 2928 02:32:41,160 --> 02:32:47,680 THAT WE NEED AND ARE FEASIBLE TO 2929 02:32:47,680 --> 02:32:52,240 DO. 2930 02:32:52,240 --> 02:32:53,840 CABOTEGRAVIR WILL HOPEFULLY BE 2931 02:32:53,840 --> 02:32:56,080 AVAILABLE SOON AND EFFECT HOW WE 2932 02:32:56,080 --> 02:32:57,640 DO OUR TRIALS MOVING FORWARD AND 2933 02:32:57,640 --> 02:33:00,280 AS SHE SAID WE CANNOT CONTINUE 2934 02:33:00,280 --> 02:33:05,600 TO RELY ON CLINICAL TRIAL 2935 02:33:05,600 --> 02:33:06,040 METHODOLOGY. 2936 02:33:06,040 --> 02:33:08,680 THE RESOURCES BECOME PROHIBITIVE 2937 02:33:08,680 --> 02:33:10,360 AND AS WELL AS THE TIME AND 2938 02:33:10,360 --> 02:33:12,520 SOMETHING WE HAVE TO CONTINUE 2939 02:33:12,520 --> 02:33:17,080 FOCUS ON HOW TO INCREASE CHOICE 2940 02:33:17,080 --> 02:33:18,880 ACROSS POPULATIONS IN NEED OF 2941 02:33:18,880 --> 02:33:20,480 HIV PREVENTION PRODUCTS AND DO 2942 02:33:20,480 --> 02:33:25,360 THAT IN A WAY THAT IS FEASIBLE 2943 02:33:25,360 --> 02:33:43,960 AND TIMELY. 2944 02:33:43,960 --> 02:33:44,760 AND WE HAVE SPOKE WITH 2945 02:33:44,760 --> 02:33:46,600 COLLEAGUES ABOUT INTEGRATING 2946 02:33:46,600 --> 02:33:47,680 BEHAVIORAL AND SOCIAL SCIENCE 2947 02:33:47,680 --> 02:33:53,120 INTO REALLY ALL OF OUR STUDIES 2948 02:33:53,120 --> 02:33:54,560 WE HAVE ALSO WORKED WITH OUR 2949 02:33:54,560 --> 02:34:00,520 CONTRACT IN THE LAST COUPLE OF 2950 02:34:00,520 --> 02:34:03,760 YEARS ON SOME ETHNIC STUDIES ON 2951 02:34:03,760 --> 02:34:06,160 YOUNG GIRLS AND WOMEN IN SOUTH 2952 02:34:06,160 --> 02:34:08,520 AFRICA TO BETTER UNDERSTAND 2953 02:34:08,520 --> 02:34:11,280 DECISION MAKE AND HOW TO CREATE 2954 02:34:11,280 --> 02:34:13,880 DESIRE FOR PREVENTION PRODUCTS 2955 02:34:13,880 --> 02:34:15,200 IN THIS POPULATION. 2956 02:34:15,200 --> 02:34:20,480 IT'S VERY CLEAR TO US WE'RE 2957 02:34:20,480 --> 02:34:23,600 GOING TO NEED TO WE'RE GOING TO 2958 02:34:23,600 --> 02:34:26,600 TAKE THE NEXT STEPS AND EXPAND 2959 02:34:26,600 --> 02:34:28,320 THE POPULATIONS WE'RE FOCUSSING 2960 02:34:28,320 --> 02:34:30,120 ON TO BETTER UNDERSTAND AND 2961 02:34:30,120 --> 02:34:32,120 ENGAGE KEY POPULATIONS AS A 2962 02:34:32,120 --> 02:34:34,280 CHALLENGE AROUND REQUIRED MUCH 2963 02:34:34,280 --> 02:34:37,120 MORE INNOVATION AND SIGNIFICANT 2964 02:34:37,120 --> 02:34:39,640 PARTNERSHIP AND THEN MAKING SURE 2965 02:34:39,640 --> 02:34:40,200 THAT WE'RE FILLING EARLY 2966 02:34:40,200 --> 02:34:56,400 PREVENTION GAPS. 2967 02:34:56,400 --> 02:35:01,440 WE HAVE A NUMBER OF UNSOLICITED 2968 02:35:01,440 --> 02:35:06,840 GRANTS AS WELL AS SOLICITED 2969 02:35:06,840 --> 02:35:07,080 PROGRAMS. 2970 02:35:07,080 --> 02:35:09,480 AROUND NOTICE AREA OF PREVENTION 2971 02:35:09,480 --> 02:35:11,080 RESEARCH AND THE CLINICAL 2972 02:35:11,080 --> 02:35:12,840 PREVENTION RESEARCH IS THE HIV 2973 02:35:12,840 --> 02:35:17,240 PREVENTION TRIALS NETWORK, THE 2974 02:35:17,240 --> 02:35:19,360 HP10 AND THE MAJOR SPECIFIC AIMS 2975 02:35:19,360 --> 02:35:21,240 ARE VERY MUCH ALIGNED WITH WHAT 2976 02:35:21,240 --> 02:35:24,880 WE'RE TRYING TO ACCOMPLISH IN 2977 02:35:24,880 --> 02:35:25,280 OUR PROGRAM. 2978 02:35:25,280 --> 02:35:33,280 NOVEL HIV PREVENTION METHODS AND 2979 02:35:33,280 --> 02:35:42,960 IMPROVING DELIVERY SYSTEMS AND 2980 02:35:42,960 --> 02:35:44,680 INTEGRATED AND SOCIO BEHAVIORAL 2981 02:35:44,680 --> 02:35:47,480 PREVENTION STRATEGIES WHICH ARE 2982 02:35:47,480 --> 02:35:51,480 KEY TOTALLY NECESSARY TO BEING 2983 02:35:51,480 --> 02:35:54,040 ABLE TO IMPLEMENT THIS WORK AND 2984 02:35:54,040 --> 02:35:55,880 CONSIDER THE WHOLE PERSON. 2985 02:35:55,880 --> 02:35:57,920 BUT I THINK THOSE OF YOU WHO 2986 02:35:57,920 --> 02:36:00,280 HAVE WORKED IN THIS AREA ALSO 2987 02:36:00,280 --> 02:36:03,120 RECOGNIZED THERE'S A NUMBER OF 2988 02:36:03,120 --> 02:36:06,120 CHALLENGES OFTEN TIMES WE ARE 2989 02:36:06,120 --> 02:36:10,280 LOOKING AT COMMUNITY RANDOMIZED 2990 02:36:10,280 --> 02:36:11,720 STUDIES, FACILITY RANDOMIZED 2991 02:36:11,720 --> 02:36:13,680 STUDIES WHICH ARE NEEDED BUT 2992 02:36:13,680 --> 02:36:15,080 PRESENT THEIR OWN CHALLENGES AND 2993 02:36:15,080 --> 02:36:17,440 THIS IS AN AREA THAT I THINK 2994 02:36:17,440 --> 02:36:20,480 WE'VE GOT TO BE WORKING TOGETHER 2995 02:36:20,480 --> 02:36:22,800 ON THINKING A LOT MORE AS WE 2996 02:36:22,800 --> 02:36:25,680 ALWAYS ARE THIS IS AN AREA TO 2997 02:36:25,680 --> 02:36:26,320 OPTIMIZE FOR SURE AS WE MOVE 2998 02:36:26,320 --> 02:36:41,840 FORWARD. 2999 02:36:41,840 --> 02:36:50,280 OPTIMIZING PATERNAL AND CHILD 3000 02:36:50,280 --> 02:36:53,760 REGIMENT S AND GETTING APPROVALS 3001 02:36:53,760 --> 02:36:59,360 AND LICENSURE FOR TREATMENTS IN 3002 02:36:59,360 --> 02:37:01,120 THE MATERNAL AND CHILD 3003 02:37:01,120 --> 02:37:04,000 POPULATIONS AND HIV AND T.B. IS 3004 02:37:04,000 --> 02:37:05,960 OFTEN YEARS BEHIND NON-PREGNANT 3005 02:37:05,960 --> 02:37:06,200 ADULTS. 3006 02:37:06,200 --> 02:37:07,360 WE'RE VERY FOCUSSED ON MOVING 3007 02:37:07,360 --> 02:37:11,440 THAT FORWARD. 3008 02:37:11,440 --> 02:37:16,280 ONE ISSUE IS CHILD FRIEND LLY 3009 02:37:16,280 --> 02:37:23,520 FORMULATIONS FOR THE YOUNGEST 3010 02:37:23,520 --> 02:37:24,680 CHILDREN AND INCLUDING PREGNANT 3011 02:37:24,680 --> 02:37:34,280 AND LACTATING WHICH WE'RE 3012 02:37:34,280 --> 02:37:36,000 COMMITTED TO THINK OF 3013 02:37:36,000 --> 02:37:38,360 ADOLESCENTS BEING SENSITIVE TO 3014 02:37:38,360 --> 02:37:41,000 THEIR NEEDS AS WE THINK NOT ONLY 3015 02:37:41,000 --> 02:37:45,680 OF THE PRODUCTS AND 3016 02:37:45,680 --> 02:37:46,280 IMPLEMENTATION BUT THE TRIALS 3017 02:37:46,280 --> 02:37:50,360 ARE BEING CONDUCTS AND LOGISTICS 3018 02:37:50,360 --> 02:37:52,080 AND CONTINUING OUR PROGRESS 3019 02:37:52,080 --> 02:37:55,480 TOWARDS HIV-FREE REMISSIONS IN 3020 02:37:55,480 --> 02:38:04,040 THE YOUNGEST POPULATIONS. 3021 02:38:04,040 --> 02:38:06,320 AND THIS ALIGNS WITH WHAT WE'RE 3022 02:38:06,320 --> 02:38:09,920 TRYING TO ACCOMPLISH IMPROVING 3023 02:38:09,920 --> 02:38:13,200 TREATMENT OF HIV AS WELL AS T.B. 3024 02:38:13,200 --> 02:38:14,920 PREVENTION AND TREATMENT 3025 02:38:14,920 --> 02:38:17,280 FOCUSSING ON COMPLICATIONS AND 3026 02:38:17,280 --> 02:38:18,760 CO-INFECTIONS OF IMPORTANCE IN 3027 02:38:18,760 --> 02:38:21,360 THESE POPULATIONS AND MOVING 3028 02:38:21,360 --> 02:38:34,800 TOWARDS ART-FREE REMISSION. 3029 02:38:34,800 --> 02:38:37,080 I WANTED TO POINT OUT I SEE THIS 3030 02:38:37,080 --> 02:38:40,760 AS A MAJOR OPPORTUNITY FOR US 3031 02:38:40,760 --> 02:38:42,200 REALLY PROVIDES ALL THESE 3032 02:38:42,200 --> 02:38:44,520 DIFFERENT SERVICES, THE GAP 3033 02:38:44,520 --> 02:38:48,080 FILLING SERVICES AND THE 3034 02:38:48,080 --> 02:38:50,240 PRECLINICAL AREA AND ANIMAL 3035 02:38:50,240 --> 02:38:53,520 MODELS AND BIO ANALYTICAL 3036 02:38:53,520 --> 02:38:54,920 SUPPORT, MANUFACTURING, QUALITY 3037 02:38:54,920 --> 02:39:01,520 SUPPORT AND THEN AS I MENTIONED 3038 02:39:01,520 --> 02:39:08,240 SPECIFICALLY THE ETHNOGRAPHIC 3039 02:39:08,240 --> 02:39:09,240 WORK AND OPPORTUNITIES MOVING 3040 02:39:09,240 --> 02:39:16,480 FORWARD. 3041 02:39:16,480 --> 02:39:17,480 THAT JUST BRINGS US BACK TO OUR 3042 02:39:17,480 --> 02:39:23,400 PRIORITIES. 3043 02:39:23,400 --> 02:39:26,480 VERY BRIEFLY, I WANTED TO 3044 02:39:26,480 --> 02:39:27,280 MENTION A COUPLE THINGS IN THE 3045 02:39:27,280 --> 02:39:29,120 COVID WORK SINCE LAST YEAR. 3046 02:39:29,120 --> 02:39:32,240 ONE, AS I THINK YOU ALL 3047 02:39:32,240 --> 02:39:33,840 REMEMBER, WE WORKED ON WITH 3048 02:39:33,840 --> 02:39:37,400 REGENERON ON THEIR STUDY FOR 3049 02:39:37,400 --> 02:39:40,680 PREVENTION AND THAT EUA WAS AIM 3050 02:39:40,680 --> 02:39:44,200 TO BE EXPANDED TO INCLUDE 3051 02:39:44,200 --> 02:39:46,640 POST-EXPOSURE PROPHYLAXIS BASED 3052 02:39:46,640 --> 02:39:50,160 ON THE CO-VPN STUDY. 3053 02:39:50,160 --> 02:39:52,600 WE RECENTLY I'M PROUD TO SAY 3054 02:39:52,600 --> 02:39:58,840 COMPLETED ENROLLMENT OF IMPACT 3055 02:39:58,840 --> 02:40:01,880 2032 THE REMDESIVIR STUDY IN 3056 02:40:01,880 --> 02:40:05,640 P.K. AND PREGNANT WOMEN AND MORE 3057 02:40:05,640 --> 02:40:10,320 COMING ON THAT HOPEFULLY BEFORE 3058 02:40:10,320 --> 02:40:12,880 LONG AND HAD STAFF THAT WORKED 3059 02:40:12,880 --> 02:40:14,360 ON COVID AND STAFF WHO WORKED 3060 02:40:14,360 --> 02:40:17,600 WITH DMID ON THE VACCINE STUDIES 3061 02:40:17,600 --> 02:40:23,560 IN PREGNANT WOMEN. 3062 02:40:23,560 --> 02:40:24,280 THANK YOU VERY MUCH AND I'M 3063 02:40:24,280 --> 02:40:28,800 HAPPY TO TAKE QUESTIONS. 3064 02:40:28,800 --> 02:40:31,080 >> THANK YOU, SHERYL, THAT WAS 3065 02:40:31,080 --> 02:40:33,320 GREAT AND IMPORTANT FOCUS ON KEY 3066 02:40:33,320 --> 02:40:36,480 POPULATIONS AND THE PREVENTION 3067 02:40:36,480 --> 02:40:38,600 MODALITIES. 3068 02:40:38,600 --> 02:40:42,280 AUDREY, QUESTION THEN STEPHAUN. 3069 02:40:42,280 --> 02:40:44,600 >> IT WAS EXCITING TO SEE WHERE 3070 02:40:44,600 --> 02:40:50,000 YOU ALL SEE ADOLESCENTS AND I 3071 02:40:50,000 --> 02:40:51,280 GUESS COMBINATION PREVENTION 3072 02:40:51,280 --> 02:40:53,920 FITTING IN THE AGENDA. 3073 02:40:53,920 --> 02:41:03,640 THAT'S EXCITING. 3074 02:41:03,640 --> 02:41:07,880 I'M CURIOUS WITH WITHDRAWAL OF 3075 02:41:07,880 --> 02:41:09,640 THE RING HOW YOU ALL ENVISION 3076 02:41:09,640 --> 02:41:10,880 THAT PLAYING OUT BECAUSE I KNOW 3077 02:41:10,880 --> 02:41:17,280 IN SOME OF THE WORK WE'VE BEEN 3078 02:41:17,280 --> 02:41:20,280 DOING COLLEAGUES ARE SEEING THE 3079 02:41:20,280 --> 02:41:21,440 RING CONTINUING TO BE PART OF 3080 02:41:21,440 --> 02:41:23,600 THE CHOICE. 3081 02:41:23,600 --> 02:41:25,640 HOW DOES IT FIT WITH NIH PART OF 3082 02:41:25,640 --> 02:41:27,560 THE FUNDING MECHANISM AND THE 3083 02:41:27,560 --> 02:41:31,560 SECOND PART, FOR THE CONTRACT 3084 02:41:31,560 --> 02:41:32,280 ETHNOGRAPHIC WORK HAVE YOU 3085 02:41:32,280 --> 02:41:36,640 TALKED ABOUT RFAs IN THAT SPACE? 3086 02:41:36,640 --> 02:41:38,920 I KNOW COLLEAGUES EXCITED TO DO 3087 02:41:38,920 --> 02:41:49,320 THAT AND I'M SURE THERE'S SXE D 3088 02:41:49,320 --> 02:41:50,680 EXPEDIENCY REASONS FOR USING 3089 02:41:50,680 --> 02:41:51,120 CONTRACTORS. 3090 02:41:51,120 --> 02:41:51,840 . 3091 02:41:51,840 --> 02:41:53,320 >> STARTING WITH THE SECOND 3092 02:41:53,320 --> 02:41:54,680 QUESTION FIRST, YOU'RE RIGHT. 3093 02:41:54,680 --> 02:41:56,840 TO GET THINGS GOING IT WAS AN 3094 02:41:56,840 --> 02:42:00,800 EFFICIENT WAY TO MOVE FORWARD AS 3095 02:42:00,800 --> 02:42:01,800 AS QUICKLY AS POSSIBLE. 3096 02:42:01,800 --> 02:42:04,200 THE ETHNOGRAPHIC WORK. 3097 02:42:04,200 --> 02:42:06,080 THAT'S EXACTLY WHAT WE'RE 3098 02:42:06,080 --> 02:42:08,000 FOCUSSING ON RIGHT NOW, OKAY, 3099 02:42:08,000 --> 02:42:11,240 WHAT ARE THE NEXT STEPS. 3100 02:42:11,240 --> 02:42:12,840 TAKING WHAT WE'VE LEARNED AND 3101 02:42:12,840 --> 02:42:15,400 MAKING SURE WE DISSEMINATE THAT 3102 02:42:15,400 --> 02:42:17,640 BOTH TO THE SCIENTIFIC COMMUNITY 3103 02:42:17,640 --> 02:42:20,920 BUT REALLY TO HOPEFULLY THE 3104 02:42:20,920 --> 02:42:21,600 PIECES OF INFORMATION THAT WILL 3105 02:42:21,600 --> 02:42:24,840 BE USEFUL TO HAVE IMPLEMENTERS 3106 02:42:24,840 --> 02:42:28,000 THAT MAYBE WE'VE ALREADY LEARNED 3107 02:42:28,000 --> 02:42:30,680 AND CLEARLY THERE ARE NEXT STEPS 3108 02:42:30,680 --> 02:42:32,880 AND WHAT SHOULD THOSE BE. 3109 02:42:32,880 --> 02:42:35,240 I KNOW WE'RE CONSIDERING HAVING 3110 02:42:35,240 --> 02:42:37,560 A DISCUSSION AND POTENTIALLY 3111 02:42:37,560 --> 02:42:38,800 WORKSHOP BUT MORE TO COME ON 3112 02:42:38,800 --> 02:42:42,800 THAT AS WE MOVE FORWARD BUT 3113 02:42:42,800 --> 02:42:50,280 YOU'RE EXACTLY RIGHT. 3114 02:42:50,280 --> 02:42:54,280 BACK TO THE DAPRIVIRINE RING 3115 02:42:54,280 --> 02:42:54,560 QUESTION. 3116 02:42:54,560 --> 02:42:58,120 NIH AS I SAID IS VERY MUCH 3117 02:42:58,120 --> 02:42:59,840 COMMITTED TO COMPLETING THESE 3118 02:42:59,840 --> 02:43:00,680 BRIDGING STUDIES WHICH WILL BE 3119 02:43:00,680 --> 02:43:06,320 REQUIRED TO MOVE IT FORWARD. 3120 02:43:06,320 --> 02:43:09,680 I THINK THE RING RECEIVED 3121 02:43:09,680 --> 02:43:13,240 APPROVAL A YEAR, YEAR AND A HALF 3122 02:43:13,240 --> 02:43:22,480 AGO AND WHO PRE-QUALIFICATION. 3123 02:43:22,480 --> 02:43:24,480 I WILL SAY THE REGULATORY 3124 02:43:24,480 --> 02:43:28,600 SPONSORS FOR ALL OF THAT WORK I 3125 02:43:28,600 --> 02:43:31,120 DON'T WANT TO SPEAK FOR THEM. 3126 02:43:31,120 --> 02:43:32,760 I DO KNOW THEY ARE VERY 3127 02:43:32,760 --> 02:43:35,560 COMMITTED TO AS ARE WE, TO 3128 02:43:35,560 --> 02:43:37,680 MAKING SURE THAT THERE'S CHOICE 3129 02:43:37,680 --> 02:43:40,360 FOR POPULATIONS AND REALLY ALL 3130 02:43:40,360 --> 02:43:42,400 POPULATIONS BUT PARTICULARLY AS 3131 02:43:42,400 --> 02:43:45,560 YOU POINTED OUT SUB-SAHARAN 3132 02:43:45,560 --> 02:43:48,040 AFRICA WHERE MUCH MORE CHOICE IS 3133 02:43:48,040 --> 02:43:51,760 NEEDED AND WE NEEDED TO GET 3134 02:43:51,760 --> 02:43:52,920 EVERY AVAILABLE POSSIBILITY OUT 3135 02:43:52,920 --> 02:43:54,280 THERE. 3136 02:43:54,280 --> 02:43:56,600 I KNOW THEY HAVE FILED AND/OR 3137 02:43:56,600 --> 02:43:58,280 ARE PLANNING ON FILING IN 3138 02:43:58,280 --> 02:44:01,560 VARIOUS COUNTRIES IN SUB-SAHARAN 3139 02:44:01,560 --> 02:44:03,280 AFRICA AND MY UNDERSTANDING IS 3140 02:44:03,280 --> 02:44:18,840 THE EXPECT TO SEE THOSE THROUGH 3141 02:44:18,840 --> 02:44:19,680 AND WE HOPE THEY'LL BE ABLE TO 3142 02:44:19,680 --> 02:44:36,880 MOVE FORWARD. 3143 02:44:36,880 --> 02:44:40,120 >> AND WOMEN MAY BE ALLOWED TO 3144 02:44:40,120 --> 02:44:43,120 USE THE PRODUCT AND ANYWAY, I'M 3145 02:44:43,120 --> 02:44:44,000 SURE IT WILL BE INTERESTING TO 3146 02:44:44,000 --> 02:44:45,240 SEE HOW IT UNFOLDS. 3147 02:44:45,240 --> 02:44:46,880 >> MORE TO COME ON THAT. 3148 02:44:46,880 --> 02:44:49,640 I'M CERTAIN. 3149 02:44:49,640 --> 02:44:56,440 >> IMPORTANT DISCUSSIONS. 3150 02:44:56,440 --> 02:44:57,600 STEPHAUN, LAST QUESTION FOR 3151 02:44:57,600 --> 02:44:57,880 SHERYL. 3152 02:44:57,880 --> 02:44:59,760 >> AUDREY ASKED MY QUESTION SO 3153 02:44:59,760 --> 02:45:02,440 JUST A COMMENT TO SAY I THINK 3154 02:45:02,440 --> 02:45:04,880 IT'S REALLY IMPORTANT AND I GOT 3155 02:45:04,880 --> 02:45:05,960 FROM YOUR SLIDE THAT TALKING 3156 02:45:05,960 --> 02:45:06,520 ABOUT THE IMPORTANCE OF 3157 02:45:06,520 --> 02:45:08,280 COMMUNITY ENGAGEMENT AND I THINK 3158 02:45:08,280 --> 02:45:09,320 THAT'S BEEN A THEME IN THIS 3159 02:45:09,320 --> 02:45:11,080 MEETING AND OTHER MEETINGS. 3160 02:45:11,080 --> 02:45:15,120 I THINK IT'S IMPORTANT ALSO TO 3161 02:45:15,120 --> 02:45:16,480 CONSIDER THE COMPLICATED NATURE 3162 02:45:16,480 --> 02:45:18,040 OF CLINICAL TRIALS AND WITH THE 3163 02:45:18,040 --> 02:45:19,280 ONGOING DISCUSSIONS HOW TRIALS 3164 02:45:19,280 --> 02:45:20,840 WILL BE DESIGNED GOING FORWARD, 3165 02:45:20,840 --> 02:45:22,280 I WANTED TO COMMUNICATE HERE 3166 02:45:22,280 --> 02:45:23,960 THAT I THINK IT'S REALLY 3167 02:45:23,960 --> 02:45:26,920 IMPORTANT THAT COMMUNITIES ARE 3168 02:45:26,920 --> 02:45:30,880 ENGAGED IN THESE CONVERSATIONS 3169 02:45:30,880 --> 02:45:31,640 MEANINGFULLY SO PEOPLE CAN 3170 02:45:31,640 --> 02:45:33,240 UNDERSTAND WHAT'S HAPPENING IN 3171 02:45:33,240 --> 02:45:34,480 THE ENTERPRISE AND HOW THINGS 3172 02:45:34,480 --> 02:45:35,440 ARE MOVING FORWARD. 3173 02:45:35,440 --> 02:45:37,560 I WANTED TO MAKE THAT COMMENT. 3174 02:45:37,560 --> 02:45:39,440 >> THANK YOU. 3175 02:45:39,440 --> 02:45:40,280 COULDN'T AGREE MORE. 3176 02:45:40,280 --> 02:45:40,880 I THINK THAT'S ALWAYS BEEN THE 3177 02:45:40,880 --> 02:45:45,560 CASE. 3178 02:45:45,560 --> 02:45:47,280 WE'VE SEEN OVER THE PAST COUPLE 3179 02:45:47,280 --> 02:45:50,240 YEARS IT'S BECOME MORE 3180 02:45:50,240 --> 02:45:50,920 IMPORTANT. 3181 02:45:50,920 --> 02:45:51,480 VERY COMMITTED TO THAT. 3182 02:45:51,480 --> 02:45:53,240 >> THANK YOU FOR BRINGING THAT 3183 02:45:53,240 --> 02:45:54,200 UP. 3184 02:45:54,200 --> 02:45:55,760 VERY IMPORTANT POINT. 3185 02:45:55,760 --> 02:45:56,600 OKAY. 3186 02:45:56,600 --> 02:45:57,480 WE ARE GOING TO KEEP MOVING AND 3187 02:45:57,480 --> 02:46:10,080 I'M GOING TO TURN IT OVER FOR 3188 02:46:10,080 --> 02:46:12,600 THE OFFICE OF CLINICAL SITE 3189 02:46:12,600 --> 02:46:13,720 OVERSIGHT REPORT. 3190 02:46:13,720 --> 02:46:24,320 >> MY NAME IS MANIZHE PAYTON OF 3191 02:46:24,320 --> 02:46:26,560 THE DIVISION OF AIDS SUPPORTING 3192 02:46:26,560 --> 02:46:27,720 THE SCIENTIFIC AND PROGRAMMATIC 3193 02:46:27,720 --> 02:47:02,040 PRIORITIES ACROSS THE DIVISION. 3194 02:47:02,040 --> 02:47:10,760 I'LL GIVE AN OVERVIEW AND WE ARE 3195 02:47:10,760 --> 02:47:12,200 GIVING OVERALL SITE CAPABILITIES 3196 02:47:12,200 --> 02:47:12,760 AND PERFORMANCE. 3197 02:47:12,760 --> 02:47:15,480 WE DO THIS BY WORKING WITH EACH 3198 02:47:15,480 --> 02:47:18,640 OF THE FOUR SCIENTIFIC PROGRAMS 3199 02:47:18,640 --> 02:47:21,040 OF AIDS INCLUDING THE VACCINE 3200 02:47:21,040 --> 02:47:26,560 PROGRAM AND PREVENTION PROGRAMS 3201 02:47:26,560 --> 02:47:27,960 AND AS WELL AS WITH OUR 3202 02:47:27,960 --> 02:47:29,560 COLLEAGUES IN THE OFFICE OF 3203 02:47:29,560 --> 02:47:30,360 POLICY AND CLINICAL RESEARCH 3204 02:47:30,360 --> 02:47:33,640 OPERATIONS. 3205 02:47:33,640 --> 02:47:35,680 WE COLLABORATE EXTENSIVELY 3206 02:47:35,680 --> 02:47:38,200 INTERNALLY AND EXTERNALLY TO 3207 02:47:38,200 --> 02:47:39,720 ACHIEVE OUR MISSION. 3208 02:47:39,720 --> 02:47:43,200 EXTERNALLY WE WORK WITH OUR 3209 02:47:43,200 --> 02:47:45,640 COLLEAGUES AT THE AIDS NETWORK 3210 02:47:45,640 --> 02:47:46,720 AND COMMUNITY STAKEHOLDERS AND 3211 02:47:46,720 --> 02:47:51,280 CLINICAL SITES WORLDWIDE. 3212 02:47:51,280 --> 02:47:54,320 WE HAVE A TALENTED GROUP OF 3213 02:47:54,320 --> 02:47:56,960 INDIVIDUALS IN OUR OFFICE 3214 02:47:56,960 --> 02:47:58,280 PASSIONATE ABOUT SUPPORTING OUR 3215 02:47:58,280 --> 02:48:00,080 SITES AND OUR MISSION. 3216 02:48:00,080 --> 02:48:01,320 THEY'VE DEMONSTRATED 3217 02:48:01,320 --> 02:48:02,000 EXTRAORDINARY FLEXIBILITY SINCE 3218 02:48:02,000 --> 02:48:04,440 THE BEGINNING OF THE PANDEMIC 3219 02:48:04,440 --> 02:48:06,280 AND MANY HAVE TAKEN ON 3220 02:48:06,280 --> 02:48:08,680 ADDITIONAL RESPONSIBILITIES 3221 02:48:08,680 --> 02:48:09,800 RELATED TO COVID RESEARCH. 3222 02:48:09,800 --> 02:48:12,360 THEY'VE BEEN ABLE TO PIVOT 3223 02:48:12,360 --> 02:48:15,640 QUICKLY AND TRAILED BLAZED TO 3224 02:48:15,640 --> 02:48:18,280 COME UP WITH WAYS TO INNOVATE IN 3225 02:48:18,280 --> 02:48:19,240 THIS ENVIRONMENT. 3226 02:48:19,240 --> 02:48:21,800 THE OFFICE IS LED BY MYSELF AND 3227 02:48:21,800 --> 02:48:25,000 THE DEPUTY DIRECTOR OF OUR 3228 02:48:25,000 --> 02:48:25,240 OFFICE. 3229 02:48:25,240 --> 02:48:27,840 AND OUR OFFICE CONSISTS OF FOUR 3230 02:48:27,840 --> 02:48:28,280 BRANCHES. 3231 02:48:28,280 --> 02:48:34,120 START FROM THE LEFT, THE ASIA 3232 02:48:34,120 --> 02:48:38,080 AMERICAS BRANCH AND THE AFRICA 3233 02:48:38,080 --> 02:48:39,920 AND DOMESTIC PARTNERS BRANCH. 3234 02:48:39,920 --> 02:48:42,360 THEY'RE BOTH STAFFED BY PROGRAM 3235 02:48:42,360 --> 02:48:43,760 OFFICERS THAT MANAGE A PORTFOLIO 3236 02:48:43,760 --> 02:48:51,280 OF COMPETITIVE GRANTS CONTAINING 3237 02:48:51,280 --> 02:48:52,280 DAIDS, HIV/AIDS SITES AND THEY 3238 02:48:52,280 --> 02:48:54,400 FORM THE ENTERPRISE. 3239 02:48:54,400 --> 02:48:58,000 THEN WE HAVE THE MONITORING 3240 02:48:58,000 --> 02:48:59,400 OPERATIONS BRANCH. 3241 02:48:59,400 --> 02:49:03,080 THIS BRANCH OVERSEES THE 3242 02:49:03,080 --> 02:49:04,800 MONITORING FUNCTION ACROSS ALL 3243 02:49:04,800 --> 02:49:06,400 DAIDS CLINICAL RESEARCH SITE TO 3244 02:49:06,400 --> 02:49:07,440 FULFILL OUR REGULATORY 3245 02:49:07,440 --> 02:49:11,840 RESPONSIBILITY AS A SPONSOR TO 3246 02:49:11,840 --> 02:49:14,120 ENSURE PROTOCOL REQUIREMENTS, 3247 02:49:14,120 --> 02:49:15,240 REGULATIONS AND INTEGRATE OF 3248 02:49:15,240 --> 02:49:21,160 DATA AND SAFETY OF PARTICIPANTS. 3249 02:49:21,160 --> 02:49:23,640 THE FOURTH IS THE PHARMACEUTICAL 3250 02:49:23,640 --> 02:49:24,560 AFFAIRS BRANCH. 3251 02:49:24,560 --> 02:49:26,360 THE BRANCH IS STAFFED WITH 3252 02:49:26,360 --> 02:49:30,840 TRAINED PHARMACISTS AND PHARMACY 3253 02:49:30,840 --> 02:49:32,680 SPECIALISTS WHO PROVIDE 3254 02:49:32,680 --> 02:49:33,400 PHARMACEUTICAL PRODUCT EXPERTISE 3255 02:49:33,400 --> 02:49:35,840 TO TEAMS AND OVERSEE AND SUPPORT 3256 02:49:35,840 --> 02:49:39,280 ALL THE SITE PHARMACIES IN 3257 02:49:39,280 --> 02:49:40,480 CONDUCTING DAIDS SPONSORED 3258 02:49:40,480 --> 02:49:46,040 CLINICAL TRIALS. 3259 02:49:46,040 --> 02:49:46,680 THE CORE BUSINESS IS DESCRIBED 3260 02:49:46,680 --> 02:49:52,360 HERE. 3261 02:49:52,360 --> 02:49:53,880 FIRST RESPONSIBLE FOR MONITORING 3262 02:49:53,880 --> 02:49:56,040 AND SITE OVERSIGHT FOR OVER 200 3263 02:49:56,040 --> 02:49:57,120 SITES WORLDWIDE. 3264 02:49:57,120 --> 02:49:59,680 WE MONITOR THE SITES TO FULFILL 3265 02:49:59,680 --> 02:50:00,680 OUR REGULATORY RESPONSIBILITY AS 3266 02:50:00,680 --> 02:50:02,960 A SPONSOR AND ASSURE THE SAFETY 3267 02:50:02,960 --> 02:50:04,920 OF PARTICIPANTS AND DATA 3268 02:50:04,920 --> 02:50:05,400 QUALITY. 3269 02:50:05,400 --> 02:50:09,240 OUR STAFF EACH HAVE A PORTFOLIO 3270 02:50:09,240 --> 02:50:10,800 OF BETWEEN 15 AND 20 CLINICAL 3271 02:50:10,800 --> 02:50:12,240 RESEARCH SITES AND THE 3272 02:50:12,240 --> 02:50:14,320 ASSOCIATED GRANTS FOR WHICH THEY 3273 02:50:14,320 --> 02:50:15,880 HAVE OVERSIGHT RESPONSIBILITY. 3274 02:50:15,880 --> 02:50:18,480 AND AS YOU KNOW EACH OF OUR 3275 02:50:18,480 --> 02:50:21,840 SITES CAN PARTICIPATE IN UP TO 3276 02:50:21,840 --> 02:50:23,160 FOUR OF THE HIV/AIDS NETWORKS 3277 02:50:23,160 --> 02:50:24,680 AND WORK CLOSELY WITH THE SITES 3278 02:50:24,680 --> 02:50:27,000 TO FACILITATE THE INDIVIDUAL 3279 02:50:27,000 --> 02:50:28,360 CHALLENGES AND CONTEXTUAL ISSUES 3280 02:50:28,360 --> 02:50:34,280 TO ALLOW THEM TO OPTIMALLY 3281 02:50:34,280 --> 02:50:35,080 PARTICIPATE. 3282 02:50:35,080 --> 02:50:36,760 THE MONITORING IS OUT SOURCED TO 3283 02:50:36,760 --> 02:50:40,880 A CONTRACTOR CURRENTLY PPD OUR 3284 02:50:40,880 --> 02:50:42,080 EYES AND EARS ON THE GROUND 3285 02:50:42,080 --> 02:50:44,040 PERFORMING THE ON SITE AND IN 3286 02:50:44,040 --> 02:50:45,880 REMOTE MONITORING ACTIVITIES. 3287 02:50:45,880 --> 02:50:47,880 AND CURRENTLY, DAIDS IS 3288 02:50:47,880 --> 02:50:48,480 MONITORING OVER 90 CLINICAL 3289 02:50:48,480 --> 02:50:59,200 TRIALS. 3290 02:50:59,200 --> 02:51:01,320 AND SEVERAL DAIDS SPONSORED 3291 02:51:01,320 --> 02:51:02,280 TRIALS CONTRIBUTED DATA TO 3292 02:51:02,280 --> 02:51:03,800 MARKETING AUTHORIZATION 3293 02:51:03,800 --> 02:51:06,280 APPLICATIONS AND TRIGGERED 3294 02:51:06,280 --> 02:51:07,520 REGULATORY INSPECTIONS AT THESE 3295 02:51:07,520 --> 02:51:07,800 SITES. 3296 02:51:07,800 --> 02:51:10,200 THE SITES HAVE BEEN INSPECTED BY 3297 02:51:10,200 --> 02:51:13,080 THE USFDA, EUROPEAN MEDICINES 3298 02:51:13,080 --> 02:51:15,800 AGENCY, THE AMA AND MANY 3299 02:51:15,800 --> 02:51:18,040 NATIONAL REGULATORY AUTHORITIES 3300 02:51:18,040 --> 02:51:20,480 OUTSIDE THE U.S. SUCH AS THE 3301 02:51:20,480 --> 02:51:25,880 SOUTH AFRICA HEALTH PRODUCTS 3302 02:51:25,880 --> 02:51:27,680 REGULATORY AUTHORITY THE THAI 3303 02:51:27,680 --> 02:51:28,840 FDA AND MANY OTHER REGULATORY 3304 02:51:28,840 --> 02:51:35,920 AUTHORITIES. 3305 02:51:35,920 --> 02:51:38,240 IN ADDITION THE PHARMACEUTICAL 3306 02:51:38,240 --> 02:51:39,880 AFFAIRS BRANCH HAS DISTRIBUTION 3307 02:51:39,880 --> 02:51:45,720 AND MANAGEMENT OF STUDY SITES 3308 02:51:45,720 --> 02:51:47,200 AND IT'S INTEGRAL TO THE TEAM 3309 02:51:47,200 --> 02:51:49,320 AND WORK WITH THE TEAMS TO 3310 02:51:49,320 --> 02:51:50,880 DEVELOP AND OVERSEE STUDY 3311 02:51:50,880 --> 02:51:52,280 PRODUCT REQUIREMENTS. 3312 02:51:52,280 --> 02:51:57,960 WORKING VERY CLOSELY WITH OUR 3313 02:51:57,960 --> 02:51:59,960 CONTRACTOR, OUR CLINICAL 3314 02:51:59,960 --> 02:52:01,600 RESEARCH PRODUCT MANAGEMENT 3315 02:52:01,600 --> 02:52:07,840 CENTER DISTRIBUTES STUDY PRODUCT 3316 02:52:07,840 --> 02:52:09,520 IN THE HIGHLY REGULATED 3317 02:52:09,520 --> 02:52:10,400 ENVIRONMENT AND CURRENTLY 3318 02:52:10,400 --> 02:52:12,520 DISTRIBUTE STUDY PRODUCT TO 27 3319 02:52:12,520 --> 02:52:13,080 COUNTRIES WORLDWIDE AND ARE 3320 02:52:13,080 --> 02:52:21,880 COUNTING. 3321 02:52:21,880 --> 02:52:26,560 OVER THE PAST FEW YEARS THE 3322 02:52:26,560 --> 02:52:30,280 PANDEMIC HAS HAD US LOOK AT 3323 02:52:30,280 --> 02:52:33,520 NOVEL WAYS OBTAIN OUR GOALS AND 3324 02:52:33,520 --> 02:52:34,880 IT'S NOT OPTIMAL FOR OPERATING 3325 02:52:34,880 --> 02:52:35,960 IN A PANDEMIC VARIETY AND 3326 02:52:35,960 --> 02:52:37,840 CONTINUE TO EVALUATE AND ASSESS 3327 02:52:37,840 --> 02:52:39,280 OUR ORGANIZATIONAL PRIORITIES TO 3328 02:52:39,280 --> 02:52:41,200 ENSURE THEY CONTINUE TO REMAIN 3329 02:52:41,200 --> 02:52:41,840 RELEVANT AND PRACTICAL FOR THESE 3330 02:52:41,840 --> 02:52:46,880 TIMES. 3331 02:52:46,880 --> 02:52:50,080 AND THE FIRST IS TO IMPLEMENT 3332 02:52:50,080 --> 02:52:52,440 REMOTE APPROACHES TO OVERSIGHT. 3333 02:52:52,440 --> 02:52:54,040 WE ACKNOWLEDGE WE'RE OPERATING 3334 02:52:54,040 --> 02:53:04,440 IN A CON TRAVESTRAINED SITES AND WE 3335 02:53:04,440 --> 02:53:06,280 MAINTAIN A REGULATORY 3336 02:53:06,280 --> 02:53:07,160 RESPONSIBILITY TO PERFORM 3337 02:53:07,160 --> 02:53:09,720 MONITORING AND IMPLEMENTED A 3338 02:53:09,720 --> 02:53:17,080 REMOTE MODEL THAT FACILITATES 3339 02:53:17,080 --> 02:53:17,640 REMOTE MONITORING. 3340 02:53:17,640 --> 02:53:18,960 OUR MODEL CONTINUES TO EVOLVE 3341 02:53:18,960 --> 02:53:21,920 BASED ON FEEDBACK FROM OUR 3342 02:53:21,920 --> 02:53:23,760 EXTERNAL STAKEHOLDERS. 3343 02:53:23,760 --> 02:53:25,760 IN ADDITION, DAIDS IS EVALUATING 3344 02:53:25,760 --> 02:53:28,440 HOW TO INCORPORATE A CENTRALIZED 3345 02:53:28,440 --> 02:53:30,160 MONITORING COMPONENT TO OUR 3346 02:53:30,160 --> 02:53:31,680 ENTERPRISE TO STRENGTHEN OUR 3347 02:53:31,680 --> 02:53:33,720 OVERSIGHT OF PATIENT SAFETY, 3348 02:53:33,720 --> 02:53:36,400 INTEGRATE AND DATA QUALITY. 3349 02:53:36,400 --> 02:53:38,880 OUR ABILITY TO INTERACT ON SITE 3350 02:53:38,880 --> 02:53:41,800 HAS DIMINISHED AND THAT IMPACTS 3351 02:53:41,800 --> 02:53:43,120 SEVERAL FORMS WE PLANNED TO 3352 02:53:43,120 --> 02:53:45,040 PROVIDE TRAINING AND SUPPORT TO 3353 02:53:45,040 --> 02:53:48,040 SITES ON ISSUES SUCH AS DAIDS 3354 02:53:48,040 --> 02:53:51,000 REQUIREMENT AND INVESTIGATOR 3355 02:53:51,000 --> 02:53:51,400 RESPONSIBILITIES. 3356 02:53:51,400 --> 02:53:53,880 WE'RE PLANNING TO HOST A VIRTUAL 3357 02:53:53,880 --> 02:53:58,120 SITE TRAINING EVENT THIS YEAR TO 3358 02:53:58,120 --> 02:53:59,480 PROVIDE RESEARCH TRAINING IN AN 3359 02:53:59,480 --> 02:54:01,040 INTERACTIVE MANNER TO FACILITATE 3360 02:54:01,040 --> 02:54:06,280 REMOTE PARTICIPATION. 3361 02:54:06,280 --> 02:54:09,760 THE TIMING IS SUBJECT TO 3362 02:54:09,760 --> 02:54:12,400 CHANGING EVENTS AROUND THE 3363 02:54:12,400 --> 02:54:12,720 PANDEMIC. 3364 02:54:12,720 --> 02:54:14,720 OUR OFFICE IS GROUNDED IN THE 3365 02:54:14,720 --> 02:54:16,880 PRINCIPLE OF PARTNERSHIP AND 3366 02:54:16,880 --> 02:54:20,160 ENGAGEMENT WITH OUR STAKEHOLDERS 3367 02:54:20,160 --> 02:54:21,240 INTERNALLY AS WELL AS EXTERNALLY 3368 02:54:21,240 --> 02:54:23,280 WITH OUR NETWORK, COMMUNITY AND 3369 02:54:23,280 --> 02:54:24,200 SITE COLLEAGUES. 3370 02:54:24,200 --> 02:54:26,320 WE CAN'T ADVANCE THESE 3371 02:54:26,320 --> 02:54:27,480 INITIATIVES WITHOUT CLOSE 3372 02:54:27,480 --> 02:54:30,160 COLLABORATION WITH OUR PARTNERS. 3373 02:54:30,160 --> 02:54:31,200 THEIR FEEDBACK IS INSTRUMENTAL 3374 02:54:31,200 --> 02:54:37,440 IN DEFINING OUR PATH FORWARD. 3375 02:54:37,440 --> 02:54:40,000 WE'VE ALSO BEEN INVOLVED IN 3376 02:54:40,000 --> 02:54:41,560 ADVANCING THE NIAID RESEARCH 3377 02:54:41,560 --> 02:54:41,880 AGENDA. 3378 02:54:41,880 --> 02:54:45,840 OUR OFFICE IS INVOLVED IN THE 3379 02:54:45,840 --> 02:54:46,680 ACTIV 2 PROJECT DRIVING FORWARD 3380 02:54:46,680 --> 02:54:48,480 SITE ACTIVITIES AND MONITORING 3381 02:54:48,480 --> 02:54:49,680 AND STUDY PRODUCT DISTRIBUTION 3382 02:54:49,680 --> 02:54:52,440 AND MANAGEMENT FOR THE COVID 3383 02:54:52,440 --> 02:55:02,240 TREATMENT PROTOCOL. 3384 02:55:02,240 --> 02:55:08,080 LASTLY, WE RECOGNIZE WE'RE 3385 02:55:08,080 --> 02:55:09,480 SEEING IF THERE'S OPPORTUNITIES 3386 02:55:09,480 --> 02:55:13,040 FOR US TO SUPPORT OUR SITES AND 3387 02:55:13,040 --> 02:55:19,080 FACILITATE THEIR PARTICIPATION 3388 02:55:19,080 --> 02:55:23,240 IN RESEARCH THIS MEANS BEING 3389 02:55:23,240 --> 02:55:24,400 FLEXIBLE WITH TIME LINES AND 3390 02:55:24,400 --> 02:55:25,360 BRINGING INFORMATION TO SITE 3391 02:55:25,360 --> 02:55:27,960 FORUMS AND LISTENING TO OUR 3392 02:55:27,960 --> 02:55:28,520 SITES ABOUT THEIR SPECIFIC 3393 02:55:28,520 --> 02:55:34,600 NEEDS. 3394 02:55:34,600 --> 02:55:36,080 AS WE LOOK FORWARD, WE'RE 3395 02:55:36,080 --> 02:55:38,880 PLANNING TO USE THE LESSONS 3396 02:55:38,880 --> 02:55:41,120 WE'VE LEARNED TO EVOLVE OUR 3397 02:55:41,120 --> 02:55:42,880 PROCESSES TO SUPPORT THIS 3398 02:55:42,880 --> 02:55:44,960 CHANGING LANDSCAPE. 3399 02:55:44,960 --> 02:55:50,800 WE CONTINUE TO SYSTEMICALLY LOOK 3400 02:55:50,800 --> 02:55:52,520 AT ESTABLISHMENT OF SITES, NEW 3401 02:55:52,520 --> 02:55:53,760 LOCATIONS WHERE RESEARCH IS 3402 02:55:53,760 --> 02:55:57,640 CONDUCTED, MONITORING ACTIVITIES 3403 02:55:57,640 --> 02:55:59,320 AS WELL AS PHARMACY SUPPORT. 3404 02:55:59,320 --> 02:56:01,040 WE'RE GROUNDED IN LISTENING TO 3405 02:56:01,040 --> 02:56:03,080 OUR STAKEHOLDERS AND ANALYZING 3406 02:56:03,080 --> 02:56:06,320 THEIR FEEDBACK TO INFORMING 3407 02:56:06,320 --> 02:56:10,080 REFINEMENTS TO THEIR PROCESSES. 3408 02:56:10,080 --> 02:56:13,880 WE WANT TO CONTINUE TO PARTNER 3409 02:56:13,880 --> 02:56:16,040 WITH SITES AND WE KNOW SITES ARE 3410 02:56:16,040 --> 02:56:16,760 NOT PERFORMING AT OPTIMAL 3411 02:56:16,760 --> 02:56:18,600 CAPACITY BECAUSE OF SOME OF 3412 02:56:18,600 --> 02:56:20,480 THESE CHALLENGES SUCH AS SUPPLY 3413 02:56:20,480 --> 02:56:21,960 CHAIN ISSUES OR STAFFING 3414 02:56:21,960 --> 02:56:24,280 CHALLENGES AND THESE CHALLENGES 3415 02:56:24,280 --> 02:56:26,080 IMPACT SITE PERFORMANCE. 3416 02:56:26,080 --> 02:56:27,400 WE WANT TO CONTINUE TO DIALOGUE 3417 02:56:27,400 --> 02:56:29,320 WITH THE SITES TO UNDERSTAND THE 3418 02:56:29,320 --> 02:56:30,960 NATURE OF THESE CHALLENGES TO 3419 02:56:30,960 --> 02:56:33,080 DETERMINE HOW WE MAY BE ABLE TO 3420 02:56:33,080 --> 02:56:34,360 BETTER SUPPORT THEM AND JOINTLY 3421 02:56:34,360 --> 02:56:36,880 WORK ON SOLUTIONS. 3422 02:56:36,880 --> 02:56:38,360 WE STRIVE TO BE TRANSPARENT AND 3423 02:56:38,360 --> 02:56:40,760 PRACTICAL IN OUR APPROACHES TO 3424 02:56:40,760 --> 02:56:43,280 FULFILLING OUR REGULATORY 3425 02:56:43,280 --> 02:56:44,440 RESPONSIBILITIES. 3426 02:56:44,440 --> 02:56:46,000 AND WE CAN'T DO EVERYTHING AT 3427 02:56:46,000 --> 02:56:46,280 ONCE. 3428 02:56:46,280 --> 02:56:49,120 WE ALSO WORK WITH OUR 3429 02:56:49,120 --> 02:56:51,000 STAKEHOLDERS INTERNALLY AND 3430 02:56:51,000 --> 02:56:55,280 EXTERNALLY TO PRIORITIZE 3431 02:56:55,280 --> 02:56:57,280 IMPLEMENTATION FACILITATING 3432 02:56:57,280 --> 02:56:59,240 DAIDS SCIENTIFIC PRIORITIES. 3433 02:56:59,240 --> 02:57:00,920 SO WITH THAT, I'M GOING TO 3434 02:57:00,920 --> 02:57:01,200 CLOSE. 3435 02:57:01,200 --> 02:57:03,480 THIS IS A BRIEF OVERVIEW OF OUR 3436 02:57:03,480 --> 02:57:04,720 OFFICE AND WHERE WE'RE HEADED 3437 02:57:04,720 --> 02:57:05,640 AND I'M HAPPY TO TAKE ANY 3438 02:57:05,640 --> 02:57:05,880 QUESTIONS. 3439 02:57:05,880 --> 02:57:14,200 THANK YOU. 3440 02:57:14,200 --> 02:57:15,760 >> IT'S BEEN A NICE OVERVIEW AND 3441 02:57:15,760 --> 02:57:17,920 IT'S BEEN A CHALLENGING TIME TO 3442 02:57:17,920 --> 02:57:19,880 TRY TO DO THIS AND APPRECIATE 3443 02:57:19,880 --> 02:57:23,720 YOUR EFFORTS TO MAINTAIN THESE 3444 02:57:23,720 --> 02:57:26,320 SITES AND NETWORKS AMIDST ALL 3445 02:57:26,320 --> 02:57:28,480 THE COMPLEXITIES. 3446 02:57:28,480 --> 02:57:28,760 THANK YOU. 3447 02:57:28,760 --> 02:57:45,600 QUESTIONS? 3448 02:57:45,600 --> 02:57:48,520 IF PEOPLE THINK OF QUESTIONS 3449 02:57:48,520 --> 02:57:50,360 AFTERWARDS YOU CAN REACH OUT BY 3450 02:57:50,360 --> 02:58:01,360 EMAIL. 3451 02:58:01,360 --> 02:58:03,920 >> GREAT AND IMPORTANT WORK. 3452 02:58:03,920 --> 02:58:05,640 THE QUALITY OF DATA COLLECTION 3453 02:58:05,640 --> 02:58:06,600 AND SAMPLE COLLECTION AND 3454 02:58:06,600 --> 02:58:08,120 MANAGING THE OPERATIONS OF 3455 02:58:08,120 --> 02:58:08,680 CLINICAL TRIALS IS REALLY 3456 02:58:08,680 --> 02:58:16,320 IMPORTANT. 3457 02:58:16,320 --> 02:58:19,160 WHAT DO YOU SEE AS MAJOR GAPS IN 3458 02:58:19,160 --> 02:58:23,160 HELPING YOU FULFILL A MISSION OF 3459 02:58:23,160 --> 02:58:25,040 OPTIMIZING OPERATIONS AND USING 3460 02:58:25,040 --> 02:58:28,480 DIGITAL PLATFORMS TO HAVE REAL 3461 02:58:28,480 --> 02:58:30,440 TIME DASHBOARDS TO SEE HOW 3462 02:58:30,440 --> 02:58:31,680 QUALITY IS GOING AND HOW WELL 3463 02:58:31,680 --> 02:58:32,640 THEY'LL BE DOING AND MANAGING 3464 02:58:32,640 --> 02:58:45,080 OUR TRIALS? 3465 02:58:45,080 --> 02:58:47,720 >> THERE'LL ALWAYS BE TECHNOLOGY 3466 02:58:47,720 --> 02:58:49,480 TO GIVE US THE PROGRESS OF OUR 3467 02:58:49,480 --> 02:58:50,600 TRIALS AND DATA. 3468 02:58:50,600 --> 02:58:52,080 ONE OF THE IMPORTANT INITIATIVES 3469 02:58:52,080 --> 02:58:53,840 IS THE CENTRALIZED MONITORING 3470 02:58:53,840 --> 02:58:55,760 INITIATIVE WHERE WE'LL BE ABLE 3471 02:58:55,760 --> 02:58:57,560 TO APPLY STATISTICAL 3472 02:58:57,560 --> 02:58:58,680 METHODOLOGIES TO DATA QUALITY 3473 02:58:58,680 --> 02:59:00,480 AND TO THE DATA TO ASSESS THE 3474 02:59:00,480 --> 02:59:02,800 QUALITY OF DATA AND IDENTIFY 3475 02:59:02,800 --> 02:59:04,200 TRENDS THAT REMOVE OUR 3476 02:59:04,200 --> 02:59:07,000 REQUIREMENT TO BE ON SITE OR TO 3477 02:59:07,000 --> 02:59:09,280 PERFORM SOME OF THE TRADITIONAL 3478 02:59:09,280 --> 02:59:10,360 ONSITE MONITORING. 3479 02:59:10,360 --> 02:59:12,080 WE'RE EXCITED TO GET THAT OFF 3480 02:59:12,080 --> 02:59:12,520 THE GROUND. 3481 02:59:12,520 --> 02:59:14,920 THERE'S ALSO INITIATIVES IN 3482 02:59:14,920 --> 02:59:18,280 TERMS OF REMOTE ACTIVITIES THAT 3483 02:59:18,280 --> 02:59:20,680 CAN BE PARTICIPANT FACING, 3484 02:59:20,680 --> 02:59:22,680 ELECTRONIC INFORMED CONSENT TO 3485 02:59:22,680 --> 02:59:24,480 HELP FACILITATE THE AND THE 3486 02:59:24,480 --> 02:59:26,160 ADVANCEMENT OF SOME OF THE 3487 02:59:26,160 --> 02:59:27,280 ANALYTICS THAT MAY BE AVAILABLE 3488 02:59:27,280 --> 02:59:29,600 TO US TO BE ABLE TO TREND 3489 02:59:29,600 --> 02:59:33,040 PROGRESS TO BE ABLE TO LOOK AT 3490 02:59:33,040 --> 02:59:34,280 PORTFOLIOS AND CAPACITY OF 3491 02:59:34,280 --> 02:59:34,480 SITES. 3492 02:59:34,480 --> 02:59:35,560 THAT'S BEEN CHALLENGING FOR US 3493 02:59:35,560 --> 02:59:37,280 TO BE PREDICTIVE ABOUT CAPACITY 3494 02:59:37,280 --> 02:59:39,160 AND WHAT THE DRIVERS OF CAPACITY 3495 02:59:39,160 --> 02:59:42,240 ARE AT THE SITES BUT WE'RE STILL 3496 02:59:42,240 --> 02:59:44,520 TRYING TO COBBLE TOGETHER THE 3497 02:59:44,520 --> 02:59:46,080 CHARACTERISTICS OF SITES TO BE 3498 02:59:46,080 --> 02:59:48,520 ABLE TO SEE IF THERE'S ANY WAY 3499 02:59:48,520 --> 02:59:50,080 WE CAN GATHER ANY INFORMATION 3500 02:59:50,080 --> 02:59:51,880 ABOUT WHAT SOME OF THE DRIVERS 3501 02:59:51,880 --> 02:59:54,120 MIGHT BE ONE OF THE KEY DRIVERS, 3502 02:59:54,120 --> 02:59:59,200 SOME OF THE KEY DRIVERS. 3503 02:59:59,200 --> 03:00:02,400 THAT'S A LONG TERM GOAL. 3504 03:00:02,400 --> 03:00:04,960 WE'VE BEEN TREMENDOUSLY 3505 03:00:04,960 --> 03:00:09,040 IMPRESSED BY THE DEDICATION AND 3506 03:00:09,040 --> 03:00:13,640 PERSEVERANCE OF THE SITES TO 3507 03:00:13,640 --> 03:00:13,880 CONTINUE. 3508 03:00:13,880 --> 03:00:15,360 IT'S BEEN A MOTIVATING AND 3509 03:00:15,360 --> 03:00:16,920 INSPIRING TO SEE THE DEDICATION 3510 03:00:16,920 --> 03:00:18,640 OF THE FOLKS ON THE GROUND AND 3511 03:00:18,640 --> 03:00:20,760 WE REALLY -- PART OF WHAT WE'RE 3512 03:00:20,760 --> 03:00:22,880 DOING IS JUST LISTENING AND 3513 03:00:22,880 --> 03:00:23,600 EMPATHIZING AND UNDERSTANDING 3514 03:00:23,600 --> 03:00:26,440 WHAT THE ISSUES ARE TO TRY TO 3515 03:00:26,440 --> 03:00:28,440 SEE HOW WE MAY BE ABLE TO WORK 3516 03:00:28,440 --> 03:00:37,760 WITH THEM TO SOLUTION. 3517 03:00:37,760 --> 03:00:44,280 >> REMARKABLE ON BOTH SIDES. 3518 03:00:44,280 --> 03:00:47,720 WE ARE GOING TO FINISH UP WITH 3519 03:00:47,720 --> 03:00:53,080 THE REPORT AND THE OFFICE OF 3520 03:00:53,080 --> 03:00:57,920 POLICY AND OPERATIONS. 3521 03:00:57,920 --> 03:01:00,280 >> THANK YOU FOR THE 3522 03:01:00,280 --> 03:01:00,600 OPPORTUNITY. 3523 03:01:00,600 --> 03:01:03,320 I PROMISE TO BE BRIEF GIVEN THIS 3524 03:01:03,320 --> 03:01:05,000 IS THE FINAL PRESENTATION. 3525 03:01:05,000 --> 03:01:07,720 SO WHAT I WANT TO DO IS GIVE AN 3526 03:01:07,720 --> 03:01:10,120 EVERY VIEW OF THE AIDES OFFICE 3527 03:01:10,120 --> 03:01:13,640 FOR POLICY AND CLINIC RESEARCH 3528 03:01:13,640 --> 03:01:18,760 ALSO KNOWN AS OPCRO. 3529 03:01:18,760 --> 03:01:21,880 I'M GOING TO START BY GIVING A 3530 03:01:21,880 --> 03:01:31,840 HIGH LEVEL INTRODUCTION OF CROW 3531 03:01:31,840 --> 03:01:36,680 AND TALKING ABOUT THE HIV 3532 03:01:36,680 --> 03:01:37,440 CLINICAL TRIALS NETWORK 3533 03:01:37,440 --> 03:01:39,880 PORTFOLIO AND IN TALKING ABOUT 3534 03:01:39,880 --> 03:01:41,680 THE KEY INFRASTRUCTURE CONTACTS 3535 03:01:41,680 --> 03:01:43,920 AND WHAT OUR ROLE HAS BEEN IN 3536 03:01:43,920 --> 03:01:49,160 SPONSOR OVERSIGHT FOR ACTIV 2. 3537 03:01:49,160 --> 03:01:51,000 SO THIS IS THE DAIDS 3538 03:01:51,000 --> 03:01:54,560 ORGANIZATIONAL STRUCTURE AND 3539 03:01:54,560 --> 03:01:55,360 DIDN'T THINK I'D BE THE FIRST TO 3540 03:01:55,360 --> 03:02:12,680 SHOW THIS. 3541 03:02:12,680 --> 03:02:15,520 ON THE FAR LEFT IS OPCRO OF 3542 03:02:15,520 --> 03:02:17,680 WHICH I'M THE DIRECTOR AND THE 3543 03:02:17,680 --> 03:02:23,160 SCIENTIFIC PROGRAMS ARE LAID OUT 3544 03:02:23,160 --> 03:02:25,200 THERE AND THEN OXO. 3545 03:02:25,200 --> 03:02:31,080 SO AS WITH THE OFFICE OF 3546 03:02:31,080 --> 03:02:35,680 CLINICAL SITE AND OVERSIGHT WE 3547 03:02:35,680 --> 03:02:37,240 COLLABORATE ACROSS THE DIVISION 3548 03:02:37,240 --> 03:02:41,000 AND SINCE MOST OF OUR RESOURCES 3549 03:02:41,000 --> 03:02:42,520 ARE GEARED TOWARDS THE CLINICAL 3550 03:02:42,520 --> 03:02:45,520 TRIALS NETWORKS WE WORK WITH 3551 03:02:45,520 --> 03:02:47,240 PREVENTION SCIENTISTS AND THE 3552 03:02:47,240 --> 03:02:51,760 VACCINE PREVENTION PROGRAMS NOT 3553 03:02:51,760 --> 03:02:53,880 SO MUCH WITH BASIC SCIENCES AND 3554 03:02:53,880 --> 03:02:54,800 NOW WE DON'T EVEN PASS EACH 3555 03:02:54,800 --> 03:03:08,120 OTHER IN THE HALLWAY. 3556 03:03:08,120 --> 03:03:09,280 WE'RE VERY DIVERSE GROUP 3557 03:03:09,280 --> 03:03:13,880 ORGANIZED INTO FOUR TEAMS AND 3558 03:03:13,880 --> 03:03:16,480 THREE BRANCHES. 3559 03:03:16,480 --> 03:03:18,920 THE FOUR TEAMS COME UNDER THE 3560 03:03:18,920 --> 03:03:21,240 OPCRO OFFICE OF THE DIRECTOR. 3561 03:03:21,240 --> 03:03:25,080 WE DEAL WITH POLICIES AND 3562 03:03:25,080 --> 03:03:30,320 PROCEDURES INCLUDING REGULATORY 3563 03:03:30,320 --> 03:03:38,120 COMPLIANCE AND WE DO IT BY 3564 03:03:38,120 --> 03:03:40,440 OVERSEEING MONITORING AND 3565 03:03:40,440 --> 03:03:42,000 REPORTING IN OUR TEAM AND 3566 03:03:42,000 --> 03:03:43,520 CLINICAL TRIALS AGREEMENTS AND 3567 03:03:43,520 --> 03:03:44,080 OTHER AGREEMENTS IN OUR CTA 3568 03:03:44,080 --> 03:03:48,320 TEAM. 3569 03:03:48,320 --> 03:03:50,200 DATA MANAGEMENT AND TRIAL MASTER 3570 03:03:50,200 --> 03:03:53,560 FILE OVERSIGHT WHICH IS THE 3571 03:03:53,560 --> 03:03:54,200 NEWEST TEAM IN THE OFFICE OF THE 3572 03:03:54,200 --> 03:04:06,240 DIRECTOR. 3573 03:04:06,240 --> 03:04:11,400 WE HAVE THE CLINICAL RESOURCES 3574 03:04:11,400 --> 03:04:18,680 BRANCH IN WHICH AND THIS ALLOWS 3575 03:04:18,680 --> 03:04:22,320 US TO DO OUR WORK. 3576 03:04:22,320 --> 03:04:24,520 SO THAT BRANCH SERVES AS A 3577 03:04:24,520 --> 03:04:26,120 TECHNICAL INTERFACE TO ENSURE 3578 03:04:26,120 --> 03:04:28,200 APPROPRIATE DELIVERY OF SERVICES 3579 03:04:28,200 --> 03:04:29,880 ACCORDING TO CONTRACT 3580 03:04:29,880 --> 03:04:30,920 REQUIREMENTS AND THEY ALSO 3581 03:04:30,920 --> 03:04:33,040 REVIEW THE RESOURCE REQUIREMENTS 3582 03:04:33,040 --> 03:04:34,320 FOR CLINICAL TRIALS AND 3583 03:04:34,320 --> 03:04:39,120 COORDINATE ACCESS TO RESOURCES 3584 03:04:39,120 --> 03:04:40,600 WITHIN DAIDS ACCESS TO THE 3585 03:04:40,600 --> 03:04:42,480 CONTRACT RESOURCES AND PROVIDE 3586 03:04:42,480 --> 03:04:44,280 RESOURCES FOR CLINICAL RESEARCH 3587 03:04:44,280 --> 03:04:52,920 TRAINING IN SEARCH SITUATIONS. 3588 03:04:52,920 --> 03:04:58,280 AND THE BRANCH PROVIDES 3589 03:04:58,280 --> 03:04:59,480 REGULATORY MANAGEMENT AND 3590 03:04:59,480 --> 03:05:01,160 GUIDANCE AND SURVEILLANCE. 3591 03:05:01,160 --> 03:05:06,280 THE MEMBERS SERVE AS AUTHORIZED 3592 03:05:06,280 --> 03:05:12,200 REPRESENTATIVES AND THEY'RE THE 3593 03:05:12,200 --> 03:05:14,440 LIAISONS WITH HEALTH AUTHORITIES 3594 03:05:14,440 --> 03:05:17,280 PARTICULARLY THE FDA THERE IS IS 3595 03:05:17,280 --> 03:05:24,720 THE PROTOCOL REGISTRATION TEAM. 3596 03:05:24,720 --> 03:05:25,960 IN MATERIALS OF HUMAN SUBJECT 3597 03:05:25,960 --> 03:05:27,680 PROTECTION OVERSIGHT IS LOCATED 3598 03:05:27,680 --> 03:05:30,800 IN A BRANCH WHICH STANDS FOR 3599 03:05:30,800 --> 03:05:33,640 PROTECTION OF PARTICIPANTS, 3600 03:05:33,640 --> 03:05:36,480 EVALUATION AND POLICY AND EASIER 3601 03:05:36,480 --> 03:05:40,000 TO REMEMBER THE HUMAN SUBJECTS 3602 03:05:40,000 --> 03:05:42,320 PROTECTION AND POLICY AND 3603 03:05:42,320 --> 03:05:48,080 PROVIDE SUBJECT MATTER EXPERTISE 3604 03:05:48,080 --> 03:05:50,400 INCLUDING IRB AND ETHICS 3605 03:05:50,400 --> 03:05:52,080 REQUIREMENTS AND DEVELOP AND 3606 03:05:52,080 --> 03:05:56,760 MAINTAIN DAIDS POLICY DOCUMENTS. 3607 03:05:56,760 --> 03:05:58,760 THERE ALSO ARE OFFICIAL LIAISON 3608 03:05:58,760 --> 03:05:59,560 TO THE HHS OFFICE OF HUMAN 3609 03:05:59,560 --> 03:06:12,760 PROTECTIONS. 3610 03:06:12,760 --> 03:06:18,720 WE DEPEND ON GOOD COLLABORATION. 3611 03:06:18,720 --> 03:06:22,960 WE WE'RE INTENSELY COLLABORATIVE 3612 03:06:22,960 --> 03:06:24,960 INSIDE DAIDS AND OUTSIDE OF 3613 03:06:24,960 --> 03:06:25,480 DAIDS. 3614 03:06:25,480 --> 03:06:28,080 THIS IS AS TYPICAL AS YOU CAN BE 3615 03:06:28,080 --> 03:06:29,840 OF A MODEL OF HOW UPDATES 3616 03:06:29,840 --> 03:06:38,880 OVERSIGHT OF TRIALS. 3617 03:06:38,880 --> 03:06:41,920 WE PROVIDE FUNDING TO OUR 3618 03:06:41,920 --> 03:06:44,600 CLINICAL TRIALS NETWORKS AND 3619 03:06:44,600 --> 03:06:48,000 SOME FUNDING AS WELL TO THE 3620 03:06:48,000 --> 03:06:48,560 CLINICAL RESEARCH SITE 3621 03:06:48,560 --> 03:06:50,280 ASSOCIATED WITH THAT NETWORK. 3622 03:06:50,280 --> 03:06:51,560 THEN THE NETWORK IS RESPONSIBLE 3623 03:06:51,560 --> 03:06:57,240 FOR THE CONDUCT OF THE TRIAL. 3624 03:06:57,240 --> 03:06:59,080 THERE'S A LEADERSHIP AND 3625 03:06:59,080 --> 03:07:01,640 OPERATIONAL CENTER AND 3626 03:07:01,640 --> 03:07:05,720 LABORATORY CENTER AND WE 3627 03:07:05,720 --> 03:07:11,840 COLLABORATE WITH ALL OF THOSE 3628 03:07:11,840 --> 03:07:14,240 AND THIS IS A SCHEMATIC THAT 3629 03:07:14,240 --> 03:07:16,360 SHOWS DIFFERENT PHASES OF THE 3630 03:07:16,360 --> 03:07:20,440 TRIAL OF A NETWORK TRIAL. 3631 03:07:20,440 --> 03:07:24,840 WE PARTICIPATE LESS IN PROTOCOL 3632 03:07:24,840 --> 03:07:26,320 INFORMED CONCEPT DEVELOPMENT 3633 03:07:26,320 --> 03:07:28,400 UNLESS BY CONSULT OR THERE'S AN 3634 03:07:28,400 --> 03:07:32,280 NIAID AND NEED FOR A PRE-NIAID 3635 03:07:32,280 --> 03:07:35,800 MEETING AND REGULATORY AFFAIRS 3636 03:07:35,800 --> 03:07:37,680 PARTICIPATES AND WE START TO 3637 03:07:37,680 --> 03:07:40,200 PARTICIPATE MORE HEAVILY WHEN WE 3638 03:07:40,200 --> 03:07:45,880 GET TO SCIENTIFIC REVIEW. 3639 03:07:45,880 --> 03:07:49,000 WE PROVIDE SEVERAL OF OUR GROUPS 3640 03:07:49,000 --> 03:07:54,120 FOR FORMAL COMMENTS AND HSP AND 3641 03:07:54,120 --> 03:08:03,640 THE PHARMACO VIGILANCE TEAM AND 3642 03:08:03,640 --> 03:08:07,000 THERE'S A NUMBER OF ACTIVITIES 3643 03:08:07,000 --> 03:08:10,840 AS THE TRIAL FINALLY GRADUATES 3644 03:08:10,840 --> 03:08:14,240 TO VERSION 1.0 AND BEYOND. 3645 03:08:14,240 --> 03:08:17,360 SO A NEW REQUIREMENT FROM US IS 3646 03:08:17,360 --> 03:08:20,240 THAT IF THE TRIAL HAS BEEN 3647 03:08:20,240 --> 03:08:22,360 PRIORITIZED AND REGISTRATIONAL 3648 03:08:22,360 --> 03:08:25,480 AND PRIORITIZES NEEDING A TRIAL 3649 03:08:25,480 --> 03:08:28,720 MASTER FILE THEN THAT HAS TO BE 3650 03:08:28,720 --> 03:08:32,400 ESTABLISHED BEFORE THE TRIAL CAN 3651 03:08:32,400 --> 03:08:32,600 BEGIN. 3652 03:08:32,600 --> 03:08:34,280 AND AT THIS POINT IS WHEN THE 3653 03:08:34,280 --> 03:08:36,400 PROTOCOL IS SUBMITTED TO THE FDA 3654 03:08:36,400 --> 03:08:38,320 AND TO THE SITES TO WORK ON AS 3655 03:08:38,320 --> 03:08:40,800 WELL. 3656 03:08:40,800 --> 03:08:43,280 THEN OUR MOST HEAVY STATE OF 3657 03:08:43,280 --> 03:08:45,600 INVOLVEME 3658 03:08:45,600 --> 03:08:47,920 INVOLVEMENT IS INSPECTION 3659 03:08:47,920 --> 03:08:49,720 PREPAREDNESS WHICH IS AN 3660 03:08:49,720 --> 03:08:51,880 ALL-HANDS ON DECK SITUATION IF A 3661 03:08:51,880 --> 03:08:53,640 TRIAL OR EVEN A SITE COMES UP 3662 03:08:53,640 --> 03:08:57,880 FOR REGULATORY INSPECTION. 3663 03:08:57,880 --> 03:09:01,960 SO I WILL SAY THIS WAS THE 3664 03:09:01,960 --> 03:09:04,360 SIMPLICITY I CAN MAKE THIS 3665 03:09:04,360 --> 03:09:04,960 SLIDE. 3666 03:09:04,960 --> 03:09:06,640 SIMPLEST I CAN MAKE THE SLIDE. 3667 03:09:06,640 --> 03:09:07,880 THE PROCESS HAS BECOME MORE AND 3668 03:09:07,880 --> 03:09:10,000 MORE COMPLICATED OVER THE LAST 3669 03:09:10,000 --> 03:09:11,560 SEVERAL YEARS AS THE REGULATORY 3670 03:09:11,560 --> 03:09:14,960 REQUIREMENTS HAVE EVOLVED. 3671 03:09:14,960 --> 03:09:16,680 SO FOR THOSE OF YOU WHO HAVE 3672 03:09:16,680 --> 03:09:20,080 NEVER HEARD OF A TRIAL MASTER 3673 03:09:20,080 --> 03:09:21,480 FILE, IT'S A COLLECTION OF 3674 03:09:21,480 --> 03:09:23,080 ESSENTIAL DOCUMENTS FOR THE 3675 03:09:23,080 --> 03:09:29,160 TRIAL THE REGULATORS USE IT AS A 3676 03:09:29,160 --> 03:09:32,880 WAY TO RECONSTRUCT WHAT YOU'VE 3677 03:09:32,880 --> 03:09:38,240 DONE LIKE A LAB NOTEBOOK AND FOR 3678 03:09:38,240 --> 03:09:40,480 A SINGLE TRIAL CONSISTS OF 3679 03:09:40,480 --> 03:09:42,080 THOUSAND OF DOCUMENTS. 3680 03:09:42,080 --> 03:09:47,680 IT SOUNDS SIMPLE LIKE YOU'RE 3681 03:09:47,680 --> 03:09:50,880 JUST FILING DUALITIES AWAY AND 3682 03:09:50,880 --> 03:09:52,920 LIKE EVERYTHING WE LAY OUR HANDS 3683 03:09:52,920 --> 03:09:55,040 ON IT'S VERY COMPLEX. 3684 03:09:55,040 --> 03:10:00,040 SO THAT IS AN EMA REQUIREMENT 3685 03:10:00,040 --> 03:10:02,280 AND THE REASON WE CARE IS 3686 03:10:02,280 --> 03:10:04,280 BECAUSE MOST OF OUR PRODUCTS AT 3687 03:10:04,280 --> 03:10:06,680 THIS POINT WE DO GLOBAL RESEARCH 3688 03:10:06,680 --> 03:10:07,920 SO WE DO FALL UNDER THE 3689 03:10:07,920 --> 03:10:13,280 REGULATIONS AND MOST OF OUR 3690 03:10:13,280 --> 03:10:15,640 PRODUCTS WILL BE MOST WANT TO 3691 03:10:15,640 --> 03:10:18,280 USE IT INTERNATIONALLY 3692 03:10:18,280 --> 03:10:28,440 ESPECIALLY IN THE HIV WORLD. 3693 03:10:28,440 --> 03:10:30,440 THEY'LL SEEK EME APPROVAL. 3694 03:10:30,440 --> 03:10:34,640 I'LL TALK MORE HOW WE DO THIS. 3695 03:10:34,640 --> 03:10:37,880 WE COLLABORATE HEAVILY ACROSS 3696 03:10:37,880 --> 03:10:38,520 THE DIVISION AND HAVE 3697 03:10:38,520 --> 03:10:47,160 ESTABLISHED GOOD PARTNERSHIPS 3698 03:10:47,160 --> 03:10:52,280 AND WE WORK WITH OUR SISTER 3699 03:10:52,280 --> 03:10:52,480 OFFICES. 3700 03:10:52,480 --> 03:10:56,400 REALLY, OUR OFFICE CONSISTS OF A 3701 03:10:56,400 --> 03:11:00,120 LITTLE OVER 30 PEOPLE ABOUT 32 3702 03:11:00,120 --> 03:11:01,920 PEOPLE AND SPARED YOU FROM THE 3703 03:11:01,920 --> 03:11:03,680 ORGANIZATIONAL SLIDE BECAUSE IT 3704 03:11:03,680 --> 03:11:09,280 WAS TOO MESSY BUT I DO WANT TO 3705 03:11:09,280 --> 03:11:10,280 EMPHASIZE THIS TYPE OF WORK 3706 03:11:10,280 --> 03:11:14,080 REQUIRES A TYPE OF PERSON WHO IS 3707 03:11:14,080 --> 03:11:14,560 WILLING AND ABLE TO BE 3708 03:11:14,560 --> 03:11:19,760 COLLABORATIVE. 3709 03:11:19,760 --> 03:11:23,200 THE REGULATORY SUPPORT CONTRACT 3710 03:11:23,200 --> 03:11:25,720 IS PART OF WHAT EXTENDS OUR 3711 03:11:25,720 --> 03:11:26,200 STAFFING ESSENTIALLY. 3712 03:11:26,200 --> 03:11:31,400 SO WE CAN GET THE WORK DONE FOR 3713 03:11:31,400 --> 03:11:32,080 A LARGE CLINICAL RESEARCH 3714 03:11:32,080 --> 03:11:32,480 PORTFOLIO. 3715 03:11:32,480 --> 03:11:35,960 SO THIS IS A FULL SERVICE 3716 03:11:35,960 --> 03:11:37,480 REGULATORY SUPPORT CONTRACT THAT 3717 03:11:37,480 --> 03:11:39,080 PROVIDES COMPREHENSIVE 3718 03:11:39,080 --> 03:11:40,200 REGULATORY SUPPORT SERVICES FOR 3719 03:11:40,200 --> 03:11:41,680 ALL DADE SUPPORTED NETWORK AND 3720 03:11:41,680 --> 03:11:45,480 SOME NON-NETWORK TRIALS. 3721 03:11:45,480 --> 03:11:48,160 THAT SUPPORT ENABLES US TO MEET 3722 03:11:48,160 --> 03:11:49,480 OUR REQUIREMENTS AND CARRY OUT 3723 03:11:49,480 --> 03:11:54,600 THE CORE MISSION OF THE OFFICE 3724 03:11:54,600 --> 03:11:58,280 WHICH IS TO SUPPORT CLINICAL 3725 03:11:58,280 --> 03:12:00,400 TRIALS RESEARCH. 3726 03:12:00,400 --> 03:12:02,840 I WON'T GO THROUGH ALL OF THIS 3727 03:12:02,840 --> 03:12:04,520 SINCE IT IS THE END OF THE DAY 3728 03:12:04,520 --> 03:12:08,000 BUT THEY PROVIDE A SIGNIFICANT 3729 03:12:08,000 --> 03:12:09,000 AMOUNT OF SUPPORT WITH RESPECT 3730 03:12:09,000 --> 03:12:12,680 TO EACH TEAM AND EACH BRANCH 3731 03:12:12,680 --> 03:12:15,360 WITHIN OPCRO. 3732 03:12:15,360 --> 03:12:31,160 THEY PROVIDI -- PROVIDE IND 3733 03:12:31,160 --> 03:12:32,000 SUPPORT AND TO OUR CLINICAL 3734 03:12:32,000 --> 03:12:33,680 TRIALS AGREEMENTS TEAM WHICH IS 3735 03:12:33,680 --> 03:12:35,280 REALLY ONLY FOUR PEOPLE. 3736 03:12:35,280 --> 03:12:36,480 OUR PROTOCOL REGISTRATION PEOPLE 3737 03:12:36,480 --> 03:12:40,400 WHICH IS TWO. 3738 03:12:40,400 --> 03:12:45,480 OUR SAFETY REPORTING TEAM AND 3739 03:12:45,480 --> 03:12:47,360 THEY OVERSEE THE REPORTING 3740 03:12:47,360 --> 03:12:50,880 SYSTEM AND DO THE INITIAL TRIAGE 3741 03:12:50,880 --> 03:12:54,280 OF EVENTS FOR THE MEDICAL 3742 03:12:54,280 --> 03:12:58,560 OFFICERS TO REVIEW. 3743 03:12:58,560 --> 03:13:02,280 THEY ALSO SUPPORT FOR 3744 03:13:02,280 --> 03:13:02,880 INSPECTION-RELATED ACTIVITIES 3745 03:13:02,880 --> 03:13:08,440 AND THE MASTER TRIAL AND WE HAVE 3746 03:13:08,440 --> 03:13:09,720 THIS INTERESTING AND USEFUL 3747 03:13:09,720 --> 03:13:13,160 HABIT OF INSPECTING OURSELVES 3748 03:13:13,160 --> 03:13:14,840 OCCASIONALLY AND WHEN WE KNOW A 3749 03:13:14,840 --> 03:13:17,120 PRODUCT IS BEING SUBMITTED BY 3750 03:13:17,120 --> 03:13:20,080 THE MANUFACTURER WE HAVE 3751 03:13:20,080 --> 03:13:20,960 INSPECTIONS AS OURSELVES AS A 3752 03:13:20,960 --> 03:13:22,480 SPONSOR AND SOME OF THE SITES WE 3753 03:13:22,480 --> 03:13:26,080 THINK ARE MOST LIKELY TO BE 3754 03:13:26,080 --> 03:13:29,280 INSPECTED AND USUALLY THAT 3755 03:13:29,280 --> 03:13:36,600 GENERATES AN INSPECTION WORKING 3756 03:13:36,600 --> 03:13:43,800 GROUP AND THEY ADDRESS REMAINING 3757 03:13:43,800 --> 03:13:45,240 ISSUES IT WHICH HAVE BEEN 3758 03:13:45,240 --> 03:13:45,680 SUCCESSFUL. 3759 03:13:45,680 --> 03:13:48,280 THE OTHER THING THE RC HAS DONE 3760 03:13:48,280 --> 03:13:55,640 OVER THE LAST TWO YEARS IS 3761 03:13:55,640 --> 03:13:57,480 SUPPORT FOR COVID-19 WITH 3762 03:13:57,480 --> 03:14:00,000 RESPECT TO PROGRAM MANAGEMENT OR 3763 03:14:00,000 --> 03:14:03,880 ACTIV 2 AND HELP WITH THE 3764 03:14:03,880 --> 03:14:05,440 CORRELATES WORK BY DOING 3765 03:14:05,440 --> 03:14:09,480 SUBMISSIONS FOR THE DRUG MASTER 3766 03:14:09,480 --> 03:14:16,480 TRIALS AND THE VACCINE INDs. 3767 03:14:16,480 --> 03:14:20,040 I WANTED TO TALK A LITTLE BIT 3768 03:14:20,040 --> 03:14:25,680 ABOUT ACTIV 2 BECAUSE IT'S BEEN 3769 03:14:25,680 --> 03:14:28,360 AN INCREDIBLY DEMANDING TIME AS 3770 03:14:28,360 --> 03:14:30,320 IT HAS FOR US AND FOR EVERYONE 3771 03:14:30,320 --> 03:14:35,400 ACROSS THE DIVISION AND MOST 3772 03:14:35,400 --> 03:14:41,280 PEOPLE ACROSS THE WORLD. 3773 03:14:41,280 --> 03:14:42,280 THIS HAS BEEN DIFFERENT FROM 3774 03:14:42,280 --> 03:14:44,480 OTHER TRIALS WHERE WE 3775 03:14:44,480 --> 03:14:45,640 SUBCONTRACTED AND CONTRACTED 3776 03:14:45,640 --> 03:14:48,280 WHAT WE USUALLY DELEGATE TO THE 3777 03:14:48,280 --> 03:14:49,280 NETWORKS IN TERMS OF CONDUCT OF 3778 03:14:49,280 --> 03:15:09,040 THE TRIAL TO A CONTRACTOR. 3779 03:15:09,040 --> 03:15:13,480 THE MAIN TRIAL WELL ALL ARE 3780 03:15:13,480 --> 03:15:15,480 ADAPTIVE TREATMENT TRIALS FOR 3781 03:15:15,480 --> 03:15:17,440 PATIENTS WITH COVID-19. 3782 03:15:17,440 --> 03:15:18,760 THEY HAVE OVERSIGHT OF THE 3783 03:15:18,760 --> 03:15:22,320 TRIALS AND FUNDED UNDER THE SS 3784 03:15:22,320 --> 03:15:26,280 COF CONTRACT WHICH I WILL TALK 3785 03:15:26,280 --> 03:15:28,240 ABOUT AND SUPPORT SERVICES 3786 03:15:28,240 --> 03:15:28,480 CONTRACT. 3787 03:15:28,480 --> 03:15:31,880 SORRY, I DIDN'T SPELL THAT OUT 3788 03:15:31,880 --> 03:15:33,760 WHICH IS HELD BY PHARMACEUTICAL 3789 03:15:33,760 --> 03:15:38,320 DEVELOPMENT A PPD FULL SERVICE 3790 03:15:38,320 --> 03:15:46,520 CONTRACT ORGANIZATION. 3791 03:15:46,520 --> 03:15:47,800 THEY OVERSEE MANY OPERATIONAL 3792 03:15:47,800 --> 03:15:49,960 ASPECTS. 3793 03:15:49,960 --> 03:15:52,440 SO WHAT THAT LOOKS LIKE AND THE 3794 03:15:52,440 --> 03:15:56,000 WAY IN WHICH THAT IS DIFFERENT 3795 03:15:56,000 --> 03:15:59,520 IS DAIDS STILL THE REGULATORY 3796 03:15:59,520 --> 03:15:59,760 SPONSOR. 3797 03:15:59,760 --> 03:16:01,640 BUT THE NETWORK IS LESS INVOLVED 3798 03:16:01,640 --> 03:16:05,720 IN FACT THE LLC AND THE SDMC ARE 3799 03:16:05,720 --> 03:16:08,880 NOT REALLY INVOLVED AT ALL. 3800 03:16:08,880 --> 03:16:10,360 IT HAS MINIMAL INVOLVEMENT IN 3801 03:16:10,360 --> 03:16:13,920 TERMS OF HELPING WITH THE 3802 03:16:13,920 --> 03:16:18,880 LABORATORY DATA MANAGEMENT 3803 03:16:18,880 --> 03:16:19,200 SYSTEM. 3804 03:16:19,200 --> 03:16:20,880 THE NETWORK AND PROTOCOL TEAM 3805 03:16:20,880 --> 03:16:25,280 ARE STILL THE NETWORK AND THE 3806 03:16:25,280 --> 03:16:25,960 NETWORK IS INVOLVED IN THE TRIAL 3807 03:16:25,960 --> 03:16:27,680 AND THE LABS. 3808 03:16:27,680 --> 03:16:33,480 THE VIROLOGY IS PROCESSED IN 3809 03:16:33,480 --> 03:16:36,400 ACTG LABS AND NOT PPD BUT THE 3810 03:16:36,400 --> 03:16:39,200 GENERAL LABS ARE ALL PROCESSED 3811 03:16:39,200 --> 03:16:40,880 BY ONE OF PPD'S LABS. 3812 03:16:40,880 --> 03:16:44,720 A CENTRAL LABORATORY. 3813 03:16:44,720 --> 03:16:49,680 AND OUR SITES AND THERE ARE ALSO 3814 03:16:49,680 --> 03:16:52,080 A HOST OF OTHER SITES THAT HAVE 3815 03:16:52,080 --> 03:16:54,560 BEEN RECRUITED AND ARE 3816 03:16:54,560 --> 03:17:10,520 CONTRACTED TO PPD DIRECTLY. 3817 03:17:10,520 --> 03:17:12,360 AND PROVIDE OVERSIGHT IN A WAY 3818 03:17:12,360 --> 03:17:15,080 IN WHICH WE HAVE NOT BEFORE. 3819 03:17:15,080 --> 03:17:19,080 I WOULD SAY THIS HAS INVOLVED 3820 03:17:19,080 --> 03:17:21,080 EVERY LEVEL OF EVERY PROGRAM AND 3821 03:17:21,080 --> 03:17:25,640 OFFICE THAT IS INVOLVED WITH 3822 03:17:25,640 --> 03:17:29,080 THIS TRIAL. 3823 03:17:29,080 --> 03:17:32,360 PETER KIM AND PAYTON AND I MEET 3824 03:17:32,360 --> 03:17:34,960 REGULARLY AND INVOLVED IN A 3825 03:17:34,960 --> 03:17:36,280 PROTOCOL LEVEL WHICH IS HONESTLY 3826 03:17:36,280 --> 03:17:44,680 NOT WHAT WE USUALLY DO. 3827 03:17:44,680 --> 03:17:46,360 WE PROVIDE OVERSIGHT IN 3828 03:17:46,360 --> 03:17:48,920 PHARMACEUTICAL MANAGEMENT AND 3829 03:17:48,920 --> 03:17:50,160 MONITORING, SAFETY, DATA 3830 03:17:50,160 --> 03:17:52,440 MANAGEMENT AND HUMAN SUBJECTS 3831 03:17:52,440 --> 03:17:52,720 PROTECTION. 3832 03:17:52,720 --> 03:17:56,400 IT'S A COMPLEX TRIAL AND THE 3833 03:17:56,400 --> 03:17:57,560 FIRST PLATFORM TRIAL THAT DAIDS 3834 03:17:57,560 --> 03:18:03,280 HAS DONE AND IT HAS BEEN QUITE 3835 03:18:03,280 --> 03:18:06,480 AN EDUCATIONAL EXPERIENCE AND I 3836 03:18:06,480 --> 03:18:08,120 WOULD SAY I'VE BEEN TOUCHED AND 3837 03:18:08,120 --> 03:18:11,240 PLEASED BY THE WAY OUR STAFF HAS 3838 03:18:11,240 --> 03:18:11,480 RESPONDED. 3839 03:18:11,480 --> 03:18:13,280 THEY HAVE RESPONDED 3840 03:18:13,280 --> 03:18:13,600 MAGNIFICENTLY. 3841 03:18:13,600 --> 03:18:20,960 THEY HAVE RISEN TO THE OCCASION. 3842 03:18:20,960 --> 03:18:24,160 EVERYONE HAS BEEN WORKING PRETTY 3843 03:18:24,160 --> 03:18:25,760 MUCH FOR THE PAST TWO YEARS AND 3844 03:18:25,760 --> 03:18:30,000 AT THE MOMENT THERE'S NOT REALLY 3845 03:18:30,000 --> 03:18:50,320 AN END IN SITE. 3846 03:18:50,320 --> 03:18:55,280 THE ACTIV 2 TRIAL IS UNDER THE 3847 03:18:55,280 --> 03:19:01,400 HIV SUPPORT SERVICES CONTRACT 3848 03:19:01,400 --> 03:19:06,480 AND IT ALOUD -- ALLOWED US TO 3849 03:19:06,480 --> 03:19:08,280 PIVOT IN A SIGNIFICANT WAY TO 3850 03:19:08,280 --> 03:19:13,160 COVID-19 AND WE USED THE 3851 03:19:13,160 --> 03:19:15,440 CONTRACT FOR OTHER OUTBREAKS 3852 03:19:15,440 --> 03:19:16,800 INCLUDING ZIKA AND OTHERS. 3853 03:19:16,800 --> 03:19:18,240 IT'S A FULL SERVICE CONTRACT 3854 03:19:18,240 --> 03:19:20,760 THAT PROVIDES A WIDE RANGE OF 3855 03:19:20,760 --> 03:19:21,920 CLINICAL AND LABORATORY AND 3856 03:19:21,920 --> 03:19:24,800 TRAINING RELATED SERVICES IN 3857 03:19:24,800 --> 03:19:28,480 SUPPORT OF OUR TRIALS. 3858 03:19:28,480 --> 03:19:31,000 IT FACILITATES AN AGILE RESPONSE 3859 03:19:31,000 --> 03:19:31,960 INCLUDING PUBLIC HEALTH 3860 03:19:31,960 --> 03:19:33,600 EMERGENCIES AND PROVIDES AD HOC 3861 03:19:33,600 --> 03:19:38,680 AND RECURRING SERVICES TO ENSURE 3862 03:19:38,680 --> 03:19:41,480 DAIDS NEEDS SPONSOR OBLIGATIONS 3863 03:19:41,480 --> 03:19:44,800 AND PROVIDE AS A BROAD RANGE OF 3864 03:19:44,800 --> 03:19:47,200 GAP FILLING AND ROUTINE CLINICAL 3865 03:19:47,200 --> 03:19:48,560 LABORATORY TRAINING AND OTHER 3866 03:19:48,560 --> 03:19:50,320 RELATED RESEARCH SUPPORT 3867 03:19:50,320 --> 03:20:00,880 SERVICES FOR DAIDS. 3868 03:20:00,880 --> 03:20:02,720 SO THIS IS AN EXAMPLE OF THE 3869 03:20:02,720 --> 03:20:06,200 URGENT WORK WE'VE IMPLEMENTED 3870 03:20:06,200 --> 03:20:08,360 INCLUDES ACTIV 2. 3871 03:20:08,360 --> 03:20:09,960 I MENTIONED ZIKA SUPPORT BEFORE. 3872 03:20:09,960 --> 03:20:13,440 SOME OF THE GAP FILLING WORK HAS 3873 03:20:13,440 --> 03:20:16,480 BEEN THIS OVER 30 WORK 3874 03:20:16,480 --> 03:20:20,920 ASSIGNMENTS ESSENTIALLY 3875 03:20:20,920 --> 03:20:22,480 SUBCONTRACTS THAT HAVE A RANGE 3876 03:20:22,480 --> 03:20:25,720 OF CONSULTANTS AND PROVIDE 3877 03:20:25,720 --> 03:20:28,120 PRE-IND SUPPORT AND DEVELOPMENT 3878 03:20:28,120 --> 03:20:30,520 AND GLP LAB AUDITS. 3879 03:20:30,520 --> 03:20:32,880 A HUGE PROGRAM. 3880 03:20:32,880 --> 03:20:39,480 WE'VE CONDUCTED 150 GCL AUDITS 3881 03:20:39,480 --> 03:20:41,760 AND PROVIDED IN-COUNTRY 3882 03:20:41,760 --> 03:20:44,800 APPLICANT REPRESENTATION FOR 3883 03:20:44,800 --> 03:20:49,040 DAIDS SPONSORED TRIALS. 3884 03:20:49,040 --> 03:20:51,000 WE ALSO PROVIDED CLINICAL SITE 3885 03:20:51,000 --> 03:20:54,720 SUPPORT AND AD HOC TECHNOLOGY 3886 03:20:54,720 --> 03:20:57,040 AND MANAGEMENT SUPPORT AND AD 3887 03:20:57,040 --> 03:20:59,000 HOC TRAINING AND IN-PERSON 3888 03:20:59,000 --> 03:21:02,280 TRAINING WHEN THAT WAS A THING 3889 03:21:02,280 --> 03:21:04,400 WHEN NECESSARY. 3890 03:21:04,400 --> 03:21:05,240 THAT IS IT. 3891 03:21:05,240 --> 03:21:07,560 SO THANK YOU FOR YOUR ATTENTION. 3892 03:21:07,560 --> 03:21:09,280 I REALIZE A FEW PEOPLE HAVE HAD 3893 03:21:09,280 --> 03:21:15,600 TO DROP OFF BUT IF THERE'S ANY 3894 03:21:15,600 --> 03:21:20,840 QUESTION 3895 03:21:20,840 --> 03:21:22,320 QUESTIONS. 3896 03:21:22,320 --> 03:21:23,160 >> THANK YOU. 3897 03:21:23,160 --> 03:21:24,480 IMPORTANT WORK TO ENSURE THE 3898 03:21:24,480 --> 03:21:26,880 QUALITY AND SAFETY OF THE DATA 3899 03:21:26,880 --> 03:21:28,120 AND EVIDENCE AND COULD NOT BE 3900 03:21:28,120 --> 03:21:30,280 MORE IMPORTANT NOW FOR US TO ALL 3901 03:21:30,280 --> 03:21:31,840 UNDERSTAND HOW MUCH WE CAN TRUST 3902 03:21:31,840 --> 03:21:33,840 THE DATA THAT HAS COME OUT OF 3903 03:21:33,840 --> 03:21:35,000 THE STUDIES AND IT'S CRITICAL. 3904 03:21:35,000 --> 03:21:37,040 AT ONE POINT YOU SAID IT SOUNDS 3905 03:21:37,040 --> 03:21:39,320 SIMPLE AND I THOUGHT, NO, NONE 3906 03:21:39,320 --> 03:21:43,200 OF US THINK IT'S SIMPLE IS THANK 3907 03:21:43,200 --> 03:21:43,360 YOU. 3908 03:21:43,360 --> 03:21:43,840 THANKS TO EVERYONE. 3909 03:21:43,840 --> 03:21:46,080 I'M GOING HAND IT TO CARL WHO I 3910 03:21:46,080 --> 03:21:50,600 THINK HAS A QUICK ONE-MINUTE -- 3911 03:21:50,600 --> 03:21:53,960 YES. 3912 03:21:53,960 --> 03:21:58,280 THANKS TO EVERYONE. 3913 03:21:58,280 --> 03:22:15,440 >> I NEED THE LIAISONS TO RAISE 3914 03:22:15,440 --> 03:22:16,400 THEIR HANDS. 3915 03:22:16,400 --> 03:22:16,680 THANK YOU. 3916 03:22:16,680 --> 03:22:18,800 THAT WAS IT. 3917 03:22:18,800 --> 03:22:20,480 >> THANK YOU. 3918 03:22:20,480 --> 03:22:22,320 THANKS TO EVERYONE. 3919 03:22:22,320 --> 03:22:23,200 GREAT PRESENTATIONS. 3920 03:22:23,200 --> 03:22:24,200 GREAT WORK. 3921 03:22:24,200 --> 03:22:26,320 WE WILL NOT BE IN PERSON IN 3922 03:22:26,320 --> 03:22:28,040 JUNE. 3923 03:22:28,040 --> 03:22:29,880 WE HOPEFULLY WILL BE IN PERSON 3924 03:22:29,880 --> 03:22:30,320 IN SEPTEMBER. 3925 03:22:30,320 --> 03:22:31,720 TAKE CARE, STAY WELL AND WE'LL 3926 03:22:31,720 --> 03:22:32,280 STAY IN TOUCH. 3927 03:22:32,280 --> 00:00:00,000 THANKS TO EVERYONE.