1 00:00:05,038 --> 00:00:11,711 >> HELLO, AND WELCOME, EVERYONE. 2 00:00:11,778 --> 00:00:13,346 I'M ELAINE ABRAMS, THE CHAIR OF 3 00:00:13,413 --> 00:00:13,780 THIS COMMITTEE. 4 00:00:13,847 --> 00:00:21,354 I'D LIKE TO WELCOME YOU TO THE Y 5 00:00:21,421 --> 00:00:21,788 COMMITTEE MEETING. 6 00:00:21,855 --> 00:00:23,156 WE HAVE A PACKED AGENDA. 7 00:00:23,223 --> 00:00:24,824 I'M VERY PLEASED TO SEE 8 00:00:24,891 --> 00:00:27,894 EVERYBODY HERE, AND THOSE FOLKS 9 00:00:27,961 --> 00:00:31,531 WHO ARE JOINING US ON ZOOM. 10 00:00:31,598 --> 00:00:34,868 WE'LL START BY DISCUSSING THE 11 00:00:34,934 --> 00:00:37,303 MINUTES FROM THE JANUARY 30TH 12 00:00:37,370 --> 00:00:39,706 MEETING, WHICH CAN BE FOUND IN 13 00:00:39,773 --> 00:00:43,343 THE ELECTRONIC COUNCIL BOOK, AND 14 00:00:43,410 --> 00:00:47,447 ARE THERE ANY COMMENTS ON THE 15 00:00:47,514 --> 00:00:50,750 MINUTES? 16 00:00:50,817 --> 00:00:54,888 IF NOT, COULD I HAVE A MOVE TO 17 00:00:54,954 --> 00:01:00,827 APPROVE THE MINUTES? 18 00:01:00,894 --> 00:01:01,127 AND SECOND? 19 00:01:01,194 --> 00:01:04,330 ALL IN FAVOR? 20 00:01:04,397 --> 00:01:05,098 OKAY, FANTASTIC. 21 00:01:05,165 --> 00:01:08,902 SO I WILL NOW TURN THE MEETING 22 00:01:08,968 --> 00:01:12,272 OVER TO CARL DIEFFENBACH, WHO 23 00:01:12,338 --> 00:01:13,373 WILL PROVIDE THE DIRECTOR'S 24 00:01:13,440 --> 00:01:19,212 REPORT. 25 00:01:19,279 --> 00:01:20,146 >> THANK YOU, ELAINE. 26 00:01:20,213 --> 00:01:21,481 IT REALLY IS A PLEASURE TO SEE 27 00:01:21,548 --> 00:01:22,782 ALL OF YOU IN ONE PLACE AND NOT 28 00:01:22,849 --> 00:01:24,884 IN A LITTLE 2 BY 2 ON A SCREEN. 29 00:01:24,951 --> 00:01:26,152 AS DIANE SAID, IT'S REALLY GREAT 30 00:01:26,219 --> 00:01:27,387 TO SEE PEOPLE IN THREE 31 00:01:27,454 --> 00:01:31,724 DIMENSIONS. 32 00:01:31,791 --> 00:01:33,726 SO I'D LIKE TO START BY 33 00:01:33,793 --> 00:01:34,828 WELCOMING YOU, BUT ALSO TO 34 00:01:34,894 --> 00:01:35,995 INTRODUCE YOU TO THE NEW MEMBERS 35 00:01:36,062 --> 00:01:37,564 OF OUR COMMITTEE. 36 00:01:37,630 --> 00:01:40,600 SO I'VE GOT A WHOLE SERIES OF 37 00:01:40,667 --> 00:01:42,168 PEOPLE AND OTHER APPOINTMENTS 38 00:01:42,235 --> 00:01:43,336 HERE AT THE NIH. 39 00:01:43,403 --> 00:01:46,306 SO FIRST UP IS DR. GRACE 40 00:01:46,372 --> 00:01:48,274 ALDROVANDI, WHO IS A 41 00:01:48,341 --> 00:01:49,476 PHYSICIAN-SCIENTIST AND CHIEF OF 42 00:01:49,542 --> 00:01:50,710 THE DIVISION OF INFECTIOUS 43 00:01:50,777 --> 00:01:53,313 DISEASES AT THE UCLA MATTEL 44 00:01:53,379 --> 00:01:54,047 CHILDREN'S HOSPITAL AND 45 00:01:54,113 --> 00:01:56,449 PROFESSOR OF PEDIATRICS AT THE 46 00:01:56,516 --> 00:01:57,584 GEFFEN SCHOOL OF MEDICINE AT 47 00:01:57,650 --> 00:01:58,418 UCLA. 48 00:01:58,485 --> 00:01:59,986 SHE CURRENTLY SERVES AS THE P.I. 49 00:02:00,053 --> 00:02:01,621 OF THE LABORATORY CENTERS FOR 50 00:02:01,688 --> 00:02:03,790 THE ACTG AND THE IMPACT 51 00:02:03,857 --> 00:02:04,324 NETWORKS. 52 00:02:04,390 --> 00:02:06,860 HER RESEARCH INTERESTS INCLUDE 53 00:02:06,926 --> 00:02:08,528 PATHOGENESIS OF HIV IN WOMEN AND 54 00:02:08,595 --> 00:02:11,231 CHILDREN AND EFFECTS OF BREAST 55 00:02:11,297 --> 00:02:13,533 MILK IN THE MICROBIOME ON INFANT 56 00:02:13,600 --> 00:02:14,601 HEALTH AND LABORATORY 57 00:02:14,667 --> 00:02:18,238 DIAGNOSTICS. 58 00:02:18,304 --> 00:02:22,609 DR. SEEMA SHAH, ACTUALLY SEEMA 59 00:02:22,675 --> 00:02:24,444 SHAH, J.D., IS THE ASSOCIATE 60 00:02:24,511 --> 00:02:26,546 PROFESSOR IN PEDIATRICS AT 61 00:02:26,613 --> 00:02:27,447 NORTHWESTERN UNIVERSITY AND 62 00:02:27,514 --> 00:02:30,283 FOUNDER'S BOARD PROFESSOR OF 63 00:02:30,350 --> 00:02:33,186 MEDICAL ETHICS AT THE LURIE 64 00:02:33,253 --> 00:02:33,887 CHILDREN'S HOSPITAL. 65 00:02:33,953 --> 00:02:35,288 SHE'S ALSO THE DIRECTOR OF 66 00:02:35,355 --> 00:02:38,057 RESEARCH ETHICS AND LEADS 67 00:02:38,124 --> 00:02:39,359 PEDIATRIC RESEARCH ETHICS 68 00:02:39,425 --> 00:02:42,195 PROGRAMS AT THE HOSPITAL. 69 00:02:42,262 --> 00:02:47,534 SHE'S ALSO A FORMER MEMBER OF OF 70 00:02:47,600 --> 00:02:48,902 THE BIOETHICS PROGRAM HERE AT 71 00:02:48,968 --> 00:02:51,070 THE NIH, AND IT IS REALLY A 72 00:02:51,137 --> 00:02:53,573 PLEASURE TO HAVE SEEMA BACK 73 00:02:53,640 --> 00:02:54,574 SERVING ON ONE OF OUR 74 00:02:54,641 --> 00:02:55,308 COMMITTEES. 75 00:02:55,375 --> 00:02:56,943 WE WORK SO WELL TOGETHER WITH 76 00:02:57,010 --> 00:03:02,415 HER AND THE GROUP IN THE PAST. 77 00:03:02,482 --> 00:03:04,717 NEXT IS KELLY GEBO, PROFESSOR OF 78 00:03:04,784 --> 00:03:06,519 MEDICINE AND EPIDEMIOLOGY AT THE 79 00:03:06,586 --> 00:03:07,520 JOHNS HOPKINS SCHOOL OF 80 00:03:07,587 --> 00:03:08,688 MEDICINE, WHERE SHE COMPLETED 81 00:03:08,755 --> 00:03:15,028 HER MEDICAL DEGREES AND INTERNAL 82 00:03:15,094 --> 00:03:15,995 MEDICINE RESIDENCY AND 83 00:03:16,062 --> 00:03:16,529 FELLOWSHIP. 84 00:03:16,596 --> 00:03:18,064 SHE IS A ROBERT WOOD JOHNSON 85 00:03:18,131 --> 00:03:20,133 CLINICAL SCHOLAR, AND RECEIVED 86 00:03:20,199 --> 00:03:21,367 AN M.P.H. FROM BLOOMBERG. 87 00:03:21,434 --> 00:03:23,303 SO THAT, WE HAVE IN COMMON FOR 88 00:03:23,369 --> 00:03:28,274 B,WE'RE BOTH GRADUATES OF 89 00:03:28,341 --> 00:03:28,575 BLOOMBERG. 90 00:03:28,641 --> 00:03:31,878 HE RESEARCH IS FOCUSED ON 91 00:03:31,945 --> 00:03:33,713 COVID-19, HIV AND OTHER 92 00:03:33,780 --> 00:03:36,015 INFECTIOUS DISEASES. 93 00:03:36,082 --> 00:03:38,151 SHE'S SERVED AS A MENTOR OR 94 00:03:38,217 --> 00:03:39,719 CO-MENTOR ON 10 JUNIOR 95 00:03:39,786 --> 00:03:42,155 INVESTIGATOR TRAINING AWARDS. 96 00:03:42,221 --> 00:03:47,193 NEXT IS TIM HENRICH. 97 00:03:47,260 --> 00:03:51,297 TIM HENRICH IS A PHYSICIAN 98 00:03:51,364 --> 00:03:52,699 SCIENTIST AND I.D. CLINICIAN, 99 00:03:52,765 --> 00:03:54,200 PROFESSOR OF MEDICINE NE 100 00:03:54,267 --> 00:03:55,702 DIVISION OF EXPERIMENTAL 101 00:03:55,768 --> 00:03:57,804 MEDICINE AT UCSF, WHERE HE RUNS 102 00:03:57,870 --> 00:03:59,472 A TRANSLATIONAL INFECTIOUS 103 00:03:59,539 --> 00:04:00,807 DISEASE RESEARCH PROGRAM 104 00:04:00,873 --> 00:04:04,477 FOCUSING ON HIV, SARS-COV-2, AND 105 00:04:04,544 --> 00:04:07,714 HUMAN HERPES VIRUSES. 106 00:04:07,780 --> 00:04:09,382 DR. HENRICH IS ALSO INVOLVED IN 107 00:04:09,449 --> 00:04:12,518 THE DESIGN AND IMPLEMENTATION OF 108 00:04:12,585 --> 00:04:14,621 NOVEL NANO AND MICRO 109 00:04:14,687 --> 00:04:16,356 TECHNOLOGIES AND PET-BASED 110 00:04:16,422 --> 00:04:17,457 IMAGING APPROACHES TO 111 00:04:17,523 --> 00:04:17,957 CHARACTERIZE RESERVOIRS. 112 00:04:18,024 --> 00:04:22,495 MOST RECENTLY, DR. HENRICH HAS 113 00:04:22,562 --> 00:04:25,531 STUDIED LONG COVID, AND THE 114 00:04:25,598 --> 00:04:27,200 OTHER IMMUNOLOGICAL SEQUELAE OF 115 00:04:27,266 --> 00:04:31,137 SARS-COV-2 INFECTION. 116 00:04:31,204 --> 00:04:36,809 NEXT IS DR. RAPHI LANDOVITZ, 117 00:04:36,876 --> 00:04:38,111 PROFESSOR OF MEDICINE AND 118 00:04:38,177 --> 00:04:39,979 INTERIM CHIEF IN THE DIVISION OF 119 00:04:40,046 --> 00:04:41,748 INFECTIOUS DISEASES AT THE 120 00:04:41,814 --> 00:04:42,949 GEFFEN SCHOOL OF MEDICINE AT 121 00:04:43,016 --> 00:04:43,716 UCLA. 122 00:04:43,783 --> 00:04:46,386 HE'S ALSO BEEN A MAJOR PLAYER IN 123 00:04:46,452 --> 00:04:50,490 THE HPTN AND SERVED AS THE 124 00:04:50,556 --> 00:04:55,628 CO-DIRECTOR, THE CO-CHAIR OF THE 125 00:04:55,695 --> 00:04:56,295 O83 TRIAL. 126 00:04:56,362 --> 00:05:00,566 HE'S PLAYED A MAJOR ROLE IN THE 127 00:05:00,633 --> 00:05:02,535 CHIPTS CENTER AND HIS RESEARCH 128 00:05:02,602 --> 00:05:04,570 CONTINUES TO FOCUS ON 129 00:05:04,637 --> 00:05:09,075 OPTIMIZATION AND USE OF 130 00:05:09,142 --> 00:05:14,347 ANTIRETROVIRALS FOR TREATMENT 131 00:05:14,414 --> 00:05:15,415 AND PREVENTION. 132 00:05:15,481 --> 00:05:24,424 NEXT IS LISHOMWA NDHLOVU, 133 00:05:24,490 --> 00:05:26,592 PROFESSOR OF IMMUNOLOGY IN 134 00:05:26,659 --> 00:05:28,127 MEDICINE, DIVISION OF INFECTIOUS 135 00:05:28,194 --> 00:05:31,764 DISEASES, SECONDARY APPOINTMENT 136 00:05:31,831 --> 00:05:33,433 AT THE RESEARCH INSTITUTE AT 137 00:05:33,499 --> 00:05:34,333 WEILL CORNELL. 138 00:05:34,400 --> 00:05:37,170 HIS TEAM COMBINES IMMUNOLOGY AND 139 00:05:37,236 --> 00:05:39,205 VIROLOGY AND EPIGENETIC METHODS, 140 00:05:39,272 --> 00:05:40,473 EXPLORING MOLECULAR MECHANISMS 141 00:05:40,540 --> 00:05:43,943 OF HIV PATHOGENESIS AND 142 00:05:44,010 --> 00:05:45,178 PERSISTENCE THROUGH PRE-CLINICAL 143 00:05:45,244 --> 00:05:48,247 AND CLINICAL INVESTIGATIONS. 144 00:05:48,314 --> 00:05:52,485 NEXT IS LINDA KOENIG, WHO'S OUR 145 00:05:52,552 --> 00:05:54,387 EX-OFFICIO ALTERNATE FROM THE 146 00:05:54,454 --> 00:05:58,825 CDC, HERE FOR THIS MEETING. 147 00:05:58,891 --> 00:06:01,928 AND I'D LIKE TO ANNOUNCE THAT ON 148 00:06:01,994 --> 00:06:05,064 THE 8TH OF APRIL, FRANCISCO RUIZ 149 00:06:05,131 --> 00:06:07,500 WAS NAMED THE DIRECTOR OF OFFICE 150 00:06:07,567 --> 00:06:11,637 OF NATIONAL AIDS POLICY, AND HIS 151 00:06:11,704 --> 00:06:12,939 APPOINTMENT IS REALLY IMPORTANT 152 00:06:13,005 --> 00:06:17,543 FOR US AS A LEADER TO HELP US 153 00:06:17,610 --> 00:06:20,646 BRING ABOUT THE EVOLUTION OF THE 154 00:06:20,713 --> 00:06:23,249 EHE PROGRAM AND CONTINUE TO HELP 155 00:06:23,316 --> 00:06:25,752 US GET TO A PLACE WHERE WE'RE 156 00:06:25,818 --> 00:06:28,488 FULLY IMPLEMENTING THE NATIONAL 157 00:06:28,554 --> 00:06:30,623 HIV/AIDS STRATEGY AS WELL AS THE 158 00:06:30,690 --> 00:06:33,226 EHE PROGRAM. 159 00:06:33,292 --> 00:06:42,368 SO HE WAS AT CDC BEFORE JOINING 160 00:06:42,435 --> 00:06:42,902 ONAP. 161 00:06:42,969 --> 00:06:43,669 THIS WAS TALKED ABOUT THIS 162 00:06:43,736 --> 00:06:45,638 MORNING BUT I REALLY WANT TO 163 00:06:45,705 --> 00:06:47,206 SPEND JUST A MOMENT MORE TALKING 164 00:06:47,273 --> 00:06:48,708 ABOUT THE NIAID LANGUAGE GUIDE 165 00:06:48,775 --> 00:06:50,343 AND HOW WE FORESEE IT BEING 166 00:06:50,409 --> 00:06:58,217 USED. 167 00:06:58,284 --> 00:07:00,186 SO WHAT WE WILL ENVISION IS 168 00:07:00,253 --> 00:07:02,355 THERE WILL BE A SERIES OF SLIDES 169 00:07:02,421 --> 00:07:03,990 THAT WHEN NIAID OR DAIDS 170 00:07:04,056 --> 00:07:05,525 SPONSORS A MEETING, WHETHER IT'S 171 00:07:05,591 --> 00:07:07,126 A NETWORK OR GROUP MEETING, THAT 172 00:07:07,193 --> 00:07:08,861 THE SLIDE WILL BE USED TO START 173 00:07:08,928 --> 00:07:10,930 THE MEETING, SETTING THE STAGE 174 00:07:10,997 --> 00:07:15,168 FOR THE IMPORTANCE OF THE NEED 175 00:07:15,234 --> 00:07:17,136 TO END THE USE OF STIGMATIZING 176 00:07:17,203 --> 00:07:18,771 LANGUAGE. 177 00:07:18,838 --> 00:07:20,206 TO PUT THAT IN THE POSITIVE, TO 178 00:07:20,273 --> 00:07:22,108 SAY WE'RE GOING TO FOCUS ON 179 00:07:22,175 --> 00:07:24,277 LANGUAGE THAT IS PERSON-CENTERED 180 00:07:24,343 --> 00:07:27,113 AND PERSON-FIRST. 181 00:07:27,180 --> 00:07:30,449 THIS IS AN AREA THAT WE'VE BEEN 182 00:07:30,516 --> 00:07:31,584 EMPHASIZING SINCE 2017, WHEN WE 183 00:07:31,651 --> 00:07:34,520 PUBLISHED OUR FIRST VERSION OF 184 00:07:34,587 --> 00:07:38,024 THIS LANGUAGE GUIDE, AND THE URL 185 00:07:38,090 --> 00:07:41,861 THERE IS THE LINK TO THE GUIDE. 186 00:07:41,928 --> 00:07:42,929 SO THIS IS WHAT IT LOOKS LIKE 187 00:07:42,995 --> 00:07:44,363 WHEN YOU GO TO THE WEBSITE. 188 00:07:44,430 --> 00:07:47,967 THE BIG BLUE BOX ALLOWS YOU TO 189 00:07:48,034 --> 00:07:50,002 DOWNLOAD THE LANGUAGE GUIDE, AND 190 00:07:50,069 --> 00:07:52,471 AT THE SAME TIME, YOU CAN SEE 191 00:07:52,538 --> 00:07:53,406 UNDER THERE ARE SUPPORTING 192 00:07:53,472 --> 00:07:54,106 MATERIALS. 193 00:07:54,173 --> 00:07:58,911 AND THESE REPRESENT SLIDES AND 194 00:07:58,978 --> 00:08:00,012 TEMPLATES THAT, DEPENDING ON 195 00:08:00,079 --> 00:08:02,181 YOUR USE AND WHETHER IT'S A 196 00:08:02,248 --> 00:08:03,616 MEETING INVITATION TORE A 197 00:08:03,683 --> 00:08:05,585 SPEAKER'S INVITATION, OR A 198 00:08:05,651 --> 00:08:07,453 SPECIFIC TEMPLATE INTRODUCTORY 199 00:08:07,520 --> 00:08:08,988 SLIDE, IT ALLOWS YOU AS A 200 00:08:09,055 --> 00:08:14,560 MEETING ORGANIZER TO TAILOR YOUR 201 00:08:14,627 --> 00:08:17,463 NEEDS SO THAT YOU HAVE THE 202 00:08:17,530 --> 00:08:18,564 ABILITY TO USE THIS LANGUAGE 203 00:08:18,631 --> 00:08:26,172 GUIDE AS WE GO FORWARD WITH OUR 204 00:08:26,239 --> 00:08:28,274 DAIDS-SPECIFIC MEETINGS. 205 00:08:28,341 --> 00:08:29,442 I'LL JUST SPEND A MOMENT GOING 206 00:08:29,508 --> 00:08:34,814 OVER THE BUDGET. 207 00:08:34,881 --> 00:08:36,415 WHEN WE MET IN JANUARY, WE STILL 208 00:08:36,482 --> 00:08:37,683 DIDN'T HAVE A BUDGET. 209 00:08:37,750 --> 00:08:41,254 WE WERE STILL UNDER THE -- WHERE 210 00:08:41,320 --> 00:08:42,154 THERE WAS STILL A POSSIBILITY OF 211 00:08:42,221 --> 00:08:45,391 A FAIRLY SUBSTANTIAL CUT. 212 00:08:45,458 --> 00:08:46,525 COULD YOU GO BACK A SLIDE? 213 00:08:46,592 --> 00:08:47,526 YOU'RE GOING JUST A LITTLE FAST 214 00:08:47,593 --> 00:08:50,596 FOR ME. 215 00:08:50,663 --> 00:08:50,863 BACK ONE. 216 00:08:50,930 --> 00:08:54,400 THANK YOU. 217 00:08:54,467 --> 00:08:55,167 THAT'S THE SLIDE. 218 00:08:55,234 --> 00:08:57,370 SO WHAT WE ENDED UP HAVING IS 219 00:08:57,436 --> 00:08:59,972 ESSENTIALLY A FLAT BUDGET FOR 220 00:09:00,039 --> 00:09:04,710 THE YEAR, WHICH WAS THE BEST BAD 221 00:09:04,777 --> 00:09:06,212 OUTCOME WE COULD ASK FOR, AND 222 00:09:06,279 --> 00:09:08,414 WE'LL SEE WHAT HAPPENS NEXT 223 00:09:08,481 --> 00:09:09,615 YEAR. 224 00:09:09,682 --> 00:09:12,018 WHAT WE HAVE SEEN, THOUGH, IS, 225 00:09:12,084 --> 00:09:13,119 BECAUSE OF THE FINANCIAL 226 00:09:13,185 --> 00:09:16,322 MANAGEMENT PLAN, WE HAVE AN 227 00:09:16,389 --> 00:09:19,959 ESTABLISHED PAYLINE FOR PIs OF 228 00:09:20,026 --> 00:09:22,828 TENTH PERCENTILE FOR NEW PIs, 229 00:09:22,895 --> 00:09:27,700 A 14TH PERCENTILE. 230 00:09:27,767 --> 00:09:28,668 NONCOMPETING GRANTS ARE BEING 231 00:09:28,734 --> 00:09:30,636 AWARDED AT 100%. 232 00:09:30,703 --> 00:09:32,605 COMPETING INVESTIGATOR-INITIATED 233 00:09:32,672 --> 00:09:36,108 AWARDS ARE BEING RELEASED AT THE 234 00:09:36,175 --> 00:09:38,344 90 PERCENT LEVEL, AND THERE'S NO 235 00:09:38,411 --> 00:09:40,479 ADJUSTMENT TO Ks, Ts AND 236 00:09:40,546 --> 00:09:42,148 Fs OR SBIR GRANTS. 237 00:09:42,214 --> 00:09:43,149 RESEARCH INITIATIVES HAVE BEEN 238 00:09:43,215 --> 00:09:44,850 CUT BY UP TO 20%. 239 00:09:44,917 --> 00:09:47,286 THIS GIVES US A PROPOSED SUCCESS 240 00:09:47,353 --> 00:09:49,021 RATE AT THE END OF THE DAY OF 241 00:09:49,088 --> 00:09:53,492 BETWEEN 16 AND 20%. 242 00:09:53,559 --> 00:09:56,062 THE PRESIDENT'S BUDGET FOR 2025 243 00:09:56,128 --> 00:09:57,330 HAS BEEN RELEASED. 244 00:09:57,396 --> 00:10:01,934 IT HAS A SMALL INCREASE PROPOSED 245 00:10:02,001 --> 00:10:03,669 OF $19 MILLION OVER 2024. 246 00:10:03,736 --> 00:10:05,938 KEEPING IN MIND, HOWEVER, THAT 247 00:10:06,005 --> 00:10:09,942 THE GROUPS IN CONGRESS ARE WHO 248 00:10:10,009 --> 00:10:14,513 WERE PROPOSING -- OKAY. 249 00:10:14,580 --> 00:10:15,848 I THINK THE EARTHQUAKE OR 250 00:10:15,915 --> 00:10:17,049 SOMETHING IS MAKING THE SLIDES 251 00:10:17,116 --> 00:10:21,153 CHANGE. 252 00:10:21,220 --> 00:10:22,621 ARE STILL PROPOSING FAIRLY 253 00:10:22,688 --> 00:10:23,856 SIGNIFICANT CUTS, SO WE'RE IN 254 00:10:23,923 --> 00:10:28,294 FOR ANOTHER ROUND OF ACTIVITIES 255 00:10:28,361 --> 00:10:29,595 GOING INTO -- SO IT WILL BE 256 00:10:29,662 --> 00:10:30,596 INTERESTING TO SEE WHERE WE ARE 257 00:10:30,663 --> 00:10:34,533 WHEN WE COME BACK IN SEPTEMBER. 258 00:10:34,600 --> 00:10:36,268 AND THEN WHEN WE GET TOGETHER IN 259 00:10:36,335 --> 00:10:38,771 JANUARY WITH ANY LUCK AT ALL, 260 00:10:38,838 --> 00:10:41,841 WE'LL HAVE A BUDGET HOPEFULLY BY 261 00:10:41,907 --> 00:10:49,715 JANUARY. 262 00:10:49,782 --> 00:10:52,651 SO THAT'S WHERE WE ARE WITH THE 263 00:10:52,718 --> 00:10:53,986 FY 25 PRESIDENT'S BUDGET AT A 264 00:10:54,053 --> 00:10:57,056 .3% INCREASE. 265 00:10:57,123 --> 00:10:59,125 SO THERE'S A COUPLE OF 266 00:10:59,191 --> 00:11:00,226 SCIENTIFIC AND PROGRAM UPDATES I 267 00:11:00,292 --> 00:11:03,863 WANT TO TALK ABOUT. 268 00:11:03,929 --> 00:11:05,798 NOT THE TRADITIONAL 269 00:11:05,865 --> 00:11:06,465 SCIENCE-BASED ONES WE'VE DONE IN 270 00:11:06,532 --> 00:11:09,735 THE PAST. 271 00:11:09,802 --> 00:11:11,370 AGAIN, THE STRATEGIC PLAN THAT 272 00:11:11,437 --> 00:11:12,738 GENIE TALKED ABOUT TODAY IS 273 00:11:12,805 --> 00:11:15,641 REALLY AN IMPORTANT PART OF 274 00:11:15,708 --> 00:11:19,678 WHERE WE ARE FOCUSING. 275 00:11:19,745 --> 00:11:21,881 THIS TIES IN VERY NICELY WITH 276 00:11:21,947 --> 00:11:22,882 WHERE WE AS A DIVISION ARE IN 277 00:11:22,948 --> 00:11:24,750 THE MIDDLE OF -- OR BEGINNING 278 00:11:24,817 --> 00:11:27,353 THE PROCESS OF LOOKING AT THE 279 00:11:27,420 --> 00:11:28,554 SIZE, SCOPE AND FUTURE DIRECTION 280 00:11:28,621 --> 00:11:31,223 OF OUR CLINICAL TRIALS 281 00:11:31,290 --> 00:11:32,691 ENTERPRISE, BECAUSE AS WE ARE 282 00:11:32,758 --> 00:11:37,963 MOVING THAT FORWARD, AND LOOKING 283 00:11:38,030 --> 00:11:43,102 AT FIRST 2027 AND THEN 2034, 284 00:11:43,169 --> 00:11:45,838 WHICH WOULD BE THE NEXT MAJOR 285 00:11:45,905 --> 00:11:47,006 RENEWAL, WE NEED TO KEEP IN MIND 286 00:11:47,073 --> 00:11:49,208 THAT THIS IS GOING TO BE TIED TO 287 00:11:49,275 --> 00:11:50,643 THE NIAID STRATEGIC PLAN. 288 00:11:50,709 --> 00:11:52,311 SO WHERE WE ARE RIGHT NOW IS 289 00:11:52,378 --> 00:11:56,682 WE'VE HAD THE RFI CLOSED, WE ARE 290 00:11:56,749 --> 00:11:58,117 GOING TO SPEND A SIGNIFICANT 291 00:11:58,184 --> 00:12:00,386 AMOUNT OF TIME GOING THROUGH THE 292 00:12:00,453 --> 00:12:03,889 INPUT THAT WE RECEIVE FROM THE 293 00:12:03,956 --> 00:12:06,492 COMMUNITY WITH THE IDEA, THEN, 294 00:12:06,559 --> 00:12:09,995 WE WILL UPDATE YOU IN SEPTEMBER, 295 00:12:10,062 --> 00:12:16,802 AND THEN AGAIN, IN JANUARY ABOUT 296 00:12:16,869 --> 00:12:18,003 PROGRESS NOT JUST ON THE 297 00:12:18,070 --> 00:12:19,405 STRATEGIC PLAN, BUT ALSO ON OUR 298 00:12:19,472 --> 00:12:20,406 PROGRESS TOWARD DEFINING THE 299 00:12:20,473 --> 00:12:21,373 SIZE, SCOPE AND FUTURE 300 00:12:21,440 --> 00:12:22,875 DIRECTIONS OF THE CLINICAL 301 00:12:22,942 --> 00:12:26,612 TRIALS ENTERPRISE. 302 00:12:26,679 --> 00:12:27,913 WE WILL NOT BE PUBLISHING 303 00:12:27,980 --> 00:12:29,748 ANYTHING IN FISCAL YEAR '25 ON 304 00:12:29,815 --> 00:12:31,584 THE NETWORKS. 305 00:12:31,650 --> 00:12:33,285 WE WILL -- IN 2025, WE'LL BE 306 00:12:33,352 --> 00:12:37,189 GOING INTO A RUN SILENT, RUN 307 00:12:37,256 --> 00:12:38,124 DEEP AFTER THE COUNCIL MEETING 308 00:12:38,190 --> 00:12:40,292 IN JANUARY AND WRITING THE 309 00:12:40,359 --> 00:12:40,826 FUNDING OPPORTUNITY 310 00:12:40,893 --> 00:12:42,928 ANNOUNCEMENTS, WHICH WILL BE 311 00:12:42,995 --> 00:12:46,532 RELEASED AND DISCUSSED AND DEALT 312 00:12:46,599 --> 00:12:50,069 WITH AS WE GO FORWARD. 313 00:12:50,136 --> 00:12:51,704 TO PUT THAT IN CONTEXT. 314 00:12:51,770 --> 00:12:55,941 HERE'S THE PROPOSED 315 00:12:56,008 --> 00:12:57,076 ORGANIZATIONAL STRUCTURE FOR OUR 316 00:12:57,143 --> 00:12:57,943 STRATEGIC PLAN, STARTING WITH 317 00:12:58,010 --> 00:12:59,445 THE VISION, MISSION, PRIORITIES, 318 00:12:59,512 --> 00:13:01,013 OBJECTIVES AND FOCUS AREAS. 319 00:13:01,080 --> 00:13:02,047 AS JEANIE SAID THIS MORNING, YOU 320 00:13:02,114 --> 00:13:04,416 MAY HAVE MISSED IT, BUT IT WAS 321 00:13:04,483 --> 00:13:06,452 KIND OF AN OFF-HAND REMARK, THIS 322 00:13:06,519 --> 00:13:10,289 STRUCTURE IS IMPOSED UPON US BY 323 00:13:10,356 --> 00:13:11,824 THE NIH O.D. THAT WE HAVE TO 324 00:13:11,891 --> 00:13:12,992 FOLLOW THIS KIND OF STRUCTURE. 325 00:13:13,058 --> 00:13:16,162 THE IDEA IS THAT ALL STRATEGIC 326 00:13:16,228 --> 00:13:20,900 PLANS WILL HAVE A SIMILAR SHAPE. 327 00:13:20,966 --> 00:13:24,803 THE PYRAMID, ACROSS THE 328 00:13:24,870 --> 00:13:25,104 INSTITUTES. 329 00:13:25,171 --> 00:13:27,006 AND AS I WAS SAYING, WE ARE IN 330 00:13:27,072 --> 00:13:29,508 THE MIDDLE OF THE NETWORK 331 00:13:29,575 --> 00:13:30,943 RESCOPING, THE NETWORK 332 00:13:31,010 --> 00:13:31,377 COMPETITION. 333 00:13:31,443 --> 00:13:36,749 TO DATE, WE'VE HAD ALL OF THE 334 00:13:36,815 --> 00:13:39,385 NETWORKS COME IN AND PRESENT 335 00:13:39,451 --> 00:13:41,020 THEIR PROGRESS TO DATE, WHAT 336 00:13:41,086 --> 00:13:42,421 THEY ARE SEEKING TO ACHIEVE IN 337 00:13:42,488 --> 00:13:44,723 THE NEXT 3 1/2 YEARS, AND THEIR 338 00:13:44,790 --> 00:13:47,359 VISION THEN FOR THE NEXT SEVEN. 339 00:13:47,426 --> 00:13:48,561 THAT HAS NOW BEEN COMPLETED. 340 00:13:48,627 --> 00:13:54,266 WE'VE HAD OUR FIRST WEBINAR THAT 341 00:13:54,333 --> 00:13:55,568 WAS JUST THIS PAST WEEK. 342 00:13:55,634 --> 00:13:59,171 WE HAD OVER 250 MEMBERS OF 343 00:13:59,238 --> 00:14:00,172 COMMUNITY AND STAKEHOLDERS ON 344 00:14:00,239 --> 00:14:05,344 THAT CALL. 345 00:14:05,411 --> 00:14:07,980 IT WAS REALLY INSIGHTFUL TO HEAR 346 00:14:08,047 --> 00:14:09,114 THE QUESTIONS AND TO GET THE 347 00:14:09,181 --> 00:14:09,448 FEEDBACK. 348 00:14:09,515 --> 00:14:13,085 WE ARE GOING TO HAVE ADDITIONAL 349 00:14:13,152 --> 00:14:18,090 CALLS. 350 00:14:18,157 --> 00:14:19,525 CAN WE GO BACK A SLIDE, PLEASE? 351 00:14:19,592 --> 00:14:21,894 I REALIZE YOU WANT TO SPEED ME 352 00:14:21,961 --> 00:14:23,329 UP BUT -- WE ARE GOING TO HAVE 353 00:14:23,395 --> 00:14:27,866 ADDITIONAL EVENT THROUGHS THROUE 354 00:14:27,933 --> 00:14:28,367 SUMMER. 355 00:14:28,434 --> 00:14:29,568 WHEN WE GET TO THE FALL MEETING, 356 00:14:29,635 --> 00:14:32,204 WE WILL HAVE A DRAFT PLAN AS A 357 00:14:32,271 --> 00:14:34,173 STRAW DOG FOR YOU AS A COMMITTEE 358 00:14:34,240 --> 00:14:38,210 TO GET INPUT INTO BASED ON YOUR 359 00:14:38,277 --> 00:14:39,345 FEEDBACK AND OTHER CONSULTATIONS 360 00:14:39,411 --> 00:14:42,615 THAT WE WILL HAVE THROUGH THE 361 00:14:42,681 --> 00:14:43,682 FALL AND INTO THE WINTER. 362 00:14:43,749 --> 00:14:45,417 WE WILL COME BACK TO YOU AS A 363 00:14:45,484 --> 00:14:49,822 COMMITTEE IN JANUARY OF 2025 364 00:14:49,888 --> 00:14:51,123 WITH A FINAL VIEW OF WHERE WE 365 00:14:51,190 --> 00:14:57,029 THINK WE HAVE ACHIEVED A DEGREE 366 00:14:57,096 --> 00:14:59,431 OF COVERAGE OF GETTING THE BEST 367 00:14:59,498 --> 00:15:01,533 INPUT WE CAN AND ALSO BEING SURE 368 00:15:01,600 --> 00:15:03,135 THAT WE'RE SOLICITING THE BEST 369 00:15:03,202 --> 00:15:05,971 SCIENCE AS WE GO FORWARD. 370 00:15:06,038 --> 00:15:11,010 WE WILL WRITE THE FOAs, AGAIN 371 00:15:11,076 --> 00:15:11,910 PUBLISHING THEM IN 2026. 372 00:15:11,977 --> 00:15:13,212 WE WILL DO THE SAME SORT OF 373 00:15:13,279 --> 00:15:14,647 THING THAT WE DID BEFORE, THAT 374 00:15:14,713 --> 00:15:18,350 WE'LL HAVE STAGGERED RELEASE OF 375 00:15:18,417 --> 00:15:21,553 SITE FOAs AND LEADERSHIP GROUP 376 00:15:21,620 --> 00:15:26,258 FFOAs WITH APPLICATIONS COMING 377 00:15:26,325 --> 00:15:27,860 BACK TO THE COUNCIL FOR FINAL 378 00:15:27,926 --> 00:15:31,363 REVIEW IN SEPTEMBER OF 2027, 379 00:15:31,430 --> 00:15:34,667 WITH A RENEWAL START DATE OF 380 00:15:34,733 --> 00:15:35,534 DECEMBER 2027, WHICH WILL BE ON 381 00:15:35,601 --> 00:15:41,707 SCHEDULE. 382 00:15:41,774 --> 00:15:42,975 SO THESE ARE OUR FUTURE 383 00:15:43,042 --> 00:15:43,342 MEETINGS. 384 00:15:43,409 --> 00:15:45,577 KEEP IN MIND THAT FOR THE 385 00:15:45,644 --> 00:15:47,012 FORESEEABLE FUTURE, ALL THE 386 00:15:47,079 --> 00:15:48,347 JANUARY COUNCIL MEETINGS WILL 387 00:15:48,414 --> 00:15:49,648 REMAIN VIRTUAL. 388 00:15:49,715 --> 00:15:52,051 WE'VE HAD SUCH GOOD LUCK WITH 389 00:15:52,117 --> 00:15:54,987 SNOWSTORMS IN PREVIOUS YEARS 390 00:15:55,054 --> 00:15:56,622 THAT THERE ALWAYS SEEMS TO BE A 391 00:15:56,689 --> 00:15:57,723 MASSIVE SNOWSTORM THAT MADE IT 392 00:15:57,790 --> 00:16:00,459 SO WE HAD TO GO VIRTUAL, SO WHY 393 00:16:00,526 --> 00:16:02,628 NOT JUST GO WITH THE INEVITABLE 394 00:16:02,695 --> 00:16:04,697 AND AS YOU CAN SEE JANUARY 26, 395 00:16:04,763 --> 00:16:07,232 YOU CAN THEN CARRY THAT INTO THE 396 00:16:07,299 --> 00:16:09,635 FUTURE, BUT SEPTEMBER AND JUNE 397 00:16:09,702 --> 00:16:11,070 MEETINGS WILL BE HYBRID AND IN 398 00:16:11,136 --> 00:16:13,472 PERSON LIKE THIS ONE. 399 00:16:13,539 --> 00:16:18,277 AND WITH THAT, I WILL CLOSE AND 400 00:16:18,344 --> 00:16:19,178 OPEN THE FLOOR TO QUESTIONS. 401 00:16:19,244 --> 00:16:21,880 SO THANK YOU. 402 00:16:21,947 --> 00:16:22,781 YOU CAN TAKE THE SLIDES DOWN 403 00:16:22,848 --> 00:16:32,925 NOW. 404 00:16:37,896 --> 00:16:46,372 IT'S OPEN FOR QUESTIONS. 405 00:16:46,438 --> 00:16:47,473 >> I THINK IT WAS VERY CLEAR. 406 00:16:47,539 --> 00:16:47,806 THANK YOU. 407 00:16:47,873 --> 00:16:49,742 >> ALL RIGHT. 408 00:16:49,808 --> 00:16:52,411 >> SO WE'LL MOVE ON NOW TO 409 00:16:52,478 --> 00:16:58,283 DR. ANNE NEILAN TO PROVIDE THE 410 00:16:58,350 --> 00:17:00,753 OFFICE OF AIDS RESEARCH ADVISORY 411 00:17:00,819 --> 00:17:04,022 COUNCIL BRIEFING. 412 00:17:04,089 --> 00:17:05,724 >> GOOD AFTERNOON, EVERYONE. 413 00:17:05,791 --> 00:17:06,759 I'M ANNE NEILAN. 414 00:17:06,825 --> 00:17:11,130 HAPPY TO BE THE OARAC LIAISON TO 415 00:17:11,196 --> 00:17:11,330 ARAC. 416 00:17:11,397 --> 00:17:12,765 THANKS FOR THE OPPORTUNITY TO 417 00:17:12,831 --> 00:17:14,166 PRESENT TODAY ON BEHALF OF OARAC 418 00:17:14,233 --> 00:17:15,567 AND GIVE A DEBRIEF AND SOME OF 419 00:17:15,634 --> 00:17:18,337 THE HIGHLIGHTS OF THE LAST OARAC 420 00:17:18,404 --> 00:17:19,538 MEETING WHICH WAS THE 65TH 421 00:17:19,605 --> 00:17:21,840 MEETING AND SHARE A FEW OTHER 422 00:17:21,907 --> 00:17:26,745 OAR-RELATED UPDATES. 423 00:17:26,812 --> 00:17:30,282 SO FIRST, LEADERSHIP 424 00:17:30,349 --> 00:17:30,816 TRANSITIONS. 425 00:17:30,883 --> 00:17:38,690 LAST YEAR DR. BILL KAPOGIA NNIS 426 00:17:38,757 --> 00:17:41,660 LEFT FOR A POSITION AT BARDA 427 00:17:41,727 --> 00:17:43,929 WITHIN THE HHS ADMINISTRATION 428 00:17:43,996 --> 00:17:46,331 FOR STRATEGIC PREPAREDNESS AND 429 00:17:46,398 --> 00:17:46,765 RESPONSE. 430 00:17:46,832 --> 00:17:51,170 AND THEN EFFECTIVE 431 00:17:51,236 --> 00:17:55,207 DECEMBER 17TH, 2023, DR. DIANA 432 00:17:55,274 --> 00:17:58,310 FINZI TOOK THE ROLE AS ACTING 433 00:17:58,377 --> 00:18:00,345 DIRECTOR WHILE THE SEARCH 434 00:18:00,412 --> 00:18:01,814 CONCLUDES. 435 00:18:01,880 --> 00:18:03,482 DIRECTOR OF THE BASIC SCIENCES 436 00:18:03,549 --> 00:18:04,283 PROGRAM IN THE DIVISION OF AIDS 437 00:18:04,349 --> 00:18:06,452 HERE AT NIAID. 438 00:18:06,518 --> 00:18:08,253 DR. FINZI IS AN IMMUNOLOGIST BY 439 00:18:08,320 --> 00:18:09,421 TRAINING AND HAS BEEN AT NIAID 440 00:18:09,488 --> 00:18:12,724 FOR OVER 20 YEARS. 441 00:18:12,791 --> 00:18:15,427 ALSO REAR ADMIRAL TIMOTHY HOLTZ 442 00:18:15,494 --> 00:18:16,395 RETIRED FROM THE U.S. PUBLIC 443 00:18:16,462 --> 00:18:17,529 HEALTH SERVICE AND FROM HIS ROLE 444 00:18:17,596 --> 00:18:21,133 AS OAR DEPUTY DIRECTOR ON 445 00:18:21,200 --> 00:18:22,668 MARCH 31ST, AND WHILE THE SEARCH 446 00:18:22,734 --> 00:18:25,103 FOR A PERMANENT DEP DEDIRECTOR 447 00:18:25,170 --> 00:18:29,141 IS ALSO ONGOING, CAPTAIN MARY 448 00:18:29,208 --> 00:18:31,109 GLENSHAW IS SERVING AS ACTING 449 00:18:31,176 --> 00:18:33,045 DEPUTY DIRECTOR AND AS THE 450 00:18:33,111 --> 00:18:34,246 DESIGNATED FEDERAL OFFICIAL FOR 451 00:18:34,313 --> 00:18:39,051 OARAC, A POSITION ALSO FORMERLY 452 00:18:39,117 --> 00:18:41,353 HELD BY REAR ADMIRAL HOLTZ. 453 00:18:41,420 --> 00:18:43,322 THE 65TH OARAC MEETING WAS HELD 454 00:18:43,388 --> 00:18:45,390 VIRTUALLY ON FEBRUARY 22ND, AND 455 00:18:45,457 --> 00:18:47,192 THAT MEETING AGENDA FEATURED A 456 00:18:47,259 --> 00:18:50,662 REPORT FROM DR. FINZI, UPDATES 457 00:18:50,729 --> 00:18:54,366 ON OAR'S PLANS FOR THE NEXT NIH 458 00:18:54,433 --> 00:19:05,143 STRATEGIC PLAN FOR NIH A HIV AND 459 00:19:06,011 --> 00:19:09,781 HIV-RELATED RESEARCH. 460 00:19:09,848 --> 00:19:11,216 HIGHLIGHTS OF THAT MEETING ALSO 461 00:19:11,283 --> 00:19:12,618 INCLUDED OARAC MEMBERS WHO 462 00:19:12,684 --> 00:19:14,753 COMPLETED THEIR TERMS, AND WERE 463 00:19:14,820 --> 00:19:15,821 PARTICIPATING IN THEIR LAST 464 00:19:15,888 --> 00:19:18,557 MEETING AS OF FEBRUARY 2024. 465 00:19:18,624 --> 00:19:20,826 SO OUTGOING MEMBERS INCLUDED 466 00:19:20,893 --> 00:19:21,460 KATHLEEN COLLINS OF THE 467 00:19:21,527 --> 00:19:23,562 UNIVERSITY OF MICHIGAN, VERONICA 468 00:19:23,629 --> 00:19:25,531 MILLER OF THE UNIVERSITY OF 469 00:19:25,597 --> 00:19:27,633 CALIFORNIA, BERKELEY SCHOOL OF 470 00:19:27,699 --> 00:19:29,935 PUBLIC HEALTH, RICARDO RIVERO, 471 00:19:30,002 --> 00:19:30,903 UNIVERSITY OF ILLINOIS AT 472 00:19:30,969 --> 00:19:31,904 CHICAGO COLLEGE OF MEDICINE, AND 473 00:19:31,970 --> 00:19:34,406 JOHN SLEASMAN, FROM DUKE 474 00:19:34,473 --> 00:19:37,476 UNIVERSITY SCHOOL OF MEDICINE. 475 00:19:37,543 --> 00:19:39,177 DR. FINZI ALSO WELCOMED THE FIVE 476 00:19:39,244 --> 00:19:40,445 INCOMING AD HOC MEMBERS ON THE 477 00:19:40,512 --> 00:19:42,614 RIGHT SOON TO BE FULL VOTING 478 00:19:42,681 --> 00:19:43,181 MEMBERS. 479 00:19:43,248 --> 00:19:43,882 COURTNEY FLETCHER OF THE 480 00:19:43,949 --> 00:19:46,018 UNIVERSITY OF NEBRASKA MEDICAL 481 00:19:46,084 --> 00:19:56,528 CENTER, SONIA FLORES, ANNA MARIA 482 00:19:56,595 --> 00:19:58,163 MANDALAKAS, DIANE SANTA MARIA 483 00:19:58,230 --> 00:20:00,699 AND SARA SAWYER FROM UNIVERSITY 484 00:20:00,766 --> 00:20:01,099 OF COLORADO. 485 00:20:01,166 --> 00:20:04,570 ALSO AT THAT MEETING DR. IVY 486 00:20:04,636 --> 00:20:05,938 TURNBULL WAS OWE FENGSLY 487 00:20:06,004 --> 00:20:10,042 RECOGNIZED AS OARAC CHAIRPERSON. 488 00:20:10,108 --> 00:20:14,179 THIS SLIDE HIGHLIGHT TWO OAR 489 00:20:14,246 --> 00:20:15,514 ENGAGEMENTS THAT OCCURRED LATE 490 00:20:15,581 --> 00:20:17,049 IN 2023 AND THOSE WERE 491 00:20:17,115 --> 00:20:18,483 NOVEMBER 2023 ON THE LEFT THERE, 492 00:20:18,550 --> 00:20:20,986 THE OAR SIGNATURE PROGRAM ON 493 00:20:21,053 --> 00:20:23,655 TECHNOLOGY ADVANCES FOR HIV 494 00:20:23,722 --> 00:20:24,489 RESEARCH. 495 00:20:24,556 --> 00:20:26,592 COLLABORATED WITH OAR'S IC 496 00:20:26,658 --> 00:20:28,427 PARTNERS TO CONVENE A TWO-DAY 497 00:20:28,493 --> 00:20:30,395 COMMUNITY-ORIENTED WORKSHOP ON 498 00:20:30,462 --> 00:20:31,697 ADVANCING HIV TESTING TECHNOLOGY 499 00:20:31,763 --> 00:20:32,931 DEVELOPMENT. 500 00:20:32,998 --> 00:20:34,132 HAROLD PHILLIPS, WHO'S GOT A 501 00:20:34,199 --> 00:20:35,667 QUOTE THERE ON THE LEFT IN 502 00:20:35,734 --> 00:20:37,235 ITALICS IN HIS ROLE AS DIRECTOR 503 00:20:37,302 --> 00:20:38,837 OF THE WHITE HOUSE OFFICE OF 504 00:20:38,904 --> 00:20:41,239 NATIONAL AIDS POLICY, WAS 505 00:20:41,306 --> 00:20:43,976 FEATURED SPEAKER AT THIS TIMELY 506 00:20:44,042 --> 00:20:44,476 WORKSHOP. 507 00:20:44,543 --> 00:20:46,612 THEN ON THE RIGHT, DECEMBER 1ST, 508 00:20:46,678 --> 00:20:51,116 2023 WAS THE 35TH WORLD AIDS 509 00:20:51,183 --> 00:20:54,252 DAY, AND OAR LED THE NIH 510 00:20:54,319 --> 00:20:57,089 OBSERVANCE WITH A VIRTUAL EVENT 511 00:20:57,155 --> 00:20:58,190 ENTITLED ACHIEVING EXCELLENCE 512 00:20:58,256 --> 00:20:59,958 AND EQUITY IN HIV RESEARCH. 513 00:21:00,025 --> 00:21:00,859 IF YOU'RE INTERESTED IN MORE 514 00:21:00,926 --> 00:21:01,827 INFORMATION ABOUT THESE EVENTS, 515 00:21:01,893 --> 00:21:06,732 THERE'S THE QR CODE ON THE SLIDE 516 00:21:06,798 --> 00:21:07,499 OR ON THE WEBSITE. 517 00:21:07,566 --> 00:21:10,002 SO THE REST OF THE MEETING 518 00:21:10,068 --> 00:21:10,902 FOCUSED ON THE DEVELOPMENT OF 519 00:21:10,969 --> 00:21:12,704 THE NEXT STRATEGIC PLAN FOR HIV 520 00:21:12,771 --> 00:21:14,606 AND HIV-RELATED RESEARCH WHICH 521 00:21:14,673 --> 00:21:16,441 IS GOING TO COVER FISCAL YEARS 522 00:21:16,508 --> 00:21:18,543 2026 AND 2030. 523 00:21:18,610 --> 00:21:21,713 THE OFFICE IS LOOKING TO -- OAR 524 00:21:21,780 --> 00:21:23,115 IS LOOKING TO OARAC AND THE 525 00:21:23,181 --> 00:21:24,316 BROADER COMMUNITY FOR INPUT AS 526 00:21:24,383 --> 00:21:25,784 IT WORKS TO DETERMINE HIV 527 00:21:25,851 --> 00:21:28,820 RESEARCH PRIORITIES, GAPS AND 528 00:21:28,887 --> 00:21:30,555 AREAS OF FOCUS. 529 00:21:30,622 --> 00:21:32,190 DR. FINZI NOTED AT THAT MEETING 530 00:21:32,257 --> 00:21:34,192 THE OPPORTUNITIES AND THE 531 00:21:34,259 --> 00:21:36,028 CHALLENGES WE FACE GIVEN MAJOR 532 00:21:36,094 --> 00:21:37,462 GAPS THAT PERSIST DESPITE 533 00:21:37,529 --> 00:21:39,431 PROGRESS ALONG THE HIV CURVE 534 00:21:39,498 --> 00:21:41,533 CONTINUUM AND JUST COMMENTED HOW 535 00:21:41,600 --> 00:21:42,934 THIS NIH HIV STRATEGIC PLAN 536 00:21:43,001 --> 00:21:47,339 WHICH PROVIDES FUNDING GUIDANCE 537 00:21:47,406 --> 00:21:48,874 FOR ALL THE DECISIONS IN THE 538 00:21:48,940 --> 00:21:51,243 SETTING OF BUDGETS NOT BEING 539 00:21:51,309 --> 00:21:52,244 LIMITED HAS THE POTENTIAL TO BE 540 00:21:52,310 --> 00:21:54,279 A VERY IMPACTFUL DOCUMENT SO 541 00:21:54,346 --> 00:21:57,149 FOLKS ARE REALLY WORKING HARD ON 542 00:21:57,215 --> 00:21:59,885 THIS. 543 00:21:59,951 --> 00:22:02,387 CAPTAIN GLENSHAW AND DR. RACHEL 544 00:22:02,454 --> 00:22:03,255 ANDERSON WENT OVER THE STUFF 545 00:22:03,321 --> 00:22:05,090 THAT'S ON THIS SLIDE, AND 546 00:22:05,157 --> 00:22:05,857 DESCRIBED THE MANY ACTIVITIES 547 00:22:05,924 --> 00:22:08,527 THEY'VE BEEN UNDERTAKING TO 548 00:22:08,593 --> 00:22:10,028 PREPARE FOR THE DEVELOPMENT OF 549 00:22:10,095 --> 00:22:14,099 THE NEXT FIVE-YEAR PLAN. 550 00:22:14,166 --> 00:22:15,167 O.A.R. PROPOSED A NEW FRAMEWORK 551 00:22:15,233 --> 00:22:17,135 THAT REFLECTS THE HIV RESEARCH 552 00:22:17,202 --> 00:22:17,736 CONTINUUM, AND THIS FRAMEWORK 553 00:22:17,803 --> 00:22:19,971 HERE IS BASED ON THREE 554 00:22:20,038 --> 00:22:21,506 FOUNDATIONAL PRINCIPLES THAT 555 00:22:21,573 --> 00:22:22,741 THEY HIGHLIGHTED. 556 00:22:22,808 --> 00:22:24,176 THE FIRST FOUNDATIONAL PRINCIPLE 557 00:22:24,242 --> 00:22:26,478 IS THAT RESEARCH TO IDENTIFY AND 558 00:22:26,545 --> 00:22:28,113 ADDRESS HIV-RELATED HEALTH 559 00:22:28,180 --> 00:22:29,614 DISPARITIES IS ESSENTIAL TO 560 00:22:29,681 --> 00:22:31,683 ENSURE THAT THE BENEFITS OF 561 00:22:31,750 --> 00:22:33,351 SCIENTIFIC ADVANCES REACH ALL 562 00:22:33,418 --> 00:22:34,319 PEOPLE AND COMMUNITIES AFFECTED 563 00:22:34,386 --> 00:22:38,924 BY HIV. 564 00:22:38,990 --> 00:22:40,759 INCLUDES GROUPS THAT HAVE BEEN 565 00:22:40,826 --> 00:22:42,027 HISTORICALLY UNDERREPRESENTED 566 00:22:42,094 --> 00:22:42,961 AND UNDERSERVED. 567 00:22:43,028 --> 00:22:44,062 THE SECOND PRINCIPLE WAS THAT 568 00:22:44,129 --> 00:22:47,899 RESEARCH MUST ADDRESS THE UNIQUE 569 00:22:47,966 --> 00:22:49,835 NEEDS OF PEOPLE WITH HIV, 570 00:22:49,901 --> 00:22:52,137 INCLUDING THOSE BORN WITH HIV. 571 00:22:52,204 --> 00:22:55,540 AND THIRD, THAT ENGAGEMENT AND 572 00:22:55,607 --> 00:22:56,208 PARTNERSHIP WITH COMMUNITIES 573 00:22:56,274 --> 00:22:57,509 AFFECTED BY HIV ARE ESSENTIAL AT 574 00:22:57,576 --> 00:23:00,812 EVERY STAGE OF RESEARCHMENT THE 575 00:23:00,879 --> 00:23:01,546 PROPOSED FRAMEWORK IS HERE ON 576 00:23:01,613 --> 00:23:02,781 THE SLIDE AND IT INCLUDES THE 577 00:23:02,848 --> 00:23:04,449 THREE BROAD RESEARCH GOALS AND 578 00:23:04,516 --> 00:23:05,951 ONE CAPACITY-BUILDING GOAL THAT 579 00:23:06,017 --> 00:23:09,421 WILL BE LINKED TO OBJECTIVES AND 580 00:23:09,488 --> 00:23:10,188 SO-CALLED TOPICAL PRIORITIES, 581 00:23:10,255 --> 00:23:12,290 AND THIS UPDATED FRAMEWORK 582 00:23:12,357 --> 00:23:13,492 REFLECTS THE INCREASING 583 00:23:13,558 --> 00:23:17,329 INTERSECTION OF HIV PREVENTION, 584 00:23:17,395 --> 00:23:18,730 TREATMENT, COMORBIDITIES AND 585 00:23:18,797 --> 00:23:19,731 RESEARCH ACROSS THE CONTINUUM. 586 00:23:19,798 --> 00:23:23,668 TO DEVELOP THIS FRAMEWORK, 587 00:23:23,735 --> 00:23:25,203 O.A.R. SUBJECT MATTER EXPERTS 588 00:23:25,270 --> 00:23:27,706 CONTRIBUTED ANTITHE NIH HIV/AIDS 589 00:23:27,773 --> 00:23:28,907 EXECUTIVE COMMITTEE WILL BOTH 590 00:23:28,974 --> 00:23:30,208 REMAIN INVOLVED THROUGHOUT THE 591 00:23:30,275 --> 00:23:31,309 STRATEGIC PLANNING PROCESS, AND 592 00:23:31,376 --> 00:23:33,411 INPUT WAS ALSO PROVIDED BY MANY 593 00:23:33,478 --> 00:23:35,714 PEOPLE, INCLUDING RESEARCHERS, 594 00:23:35,781 --> 00:23:37,015 PRACTITIONERS, COMMUNITY 595 00:23:37,082 --> 00:23:38,750 ADVOCATES, FEDERAL PARTNERS AND 596 00:23:38,817 --> 00:23:40,519 THE PUBLIC, MANY OF YOU PROBABLY 597 00:23:40,585 --> 00:23:43,822 SAW THE RFI THAT O.A.R. ISSUED 598 00:23:43,889 --> 00:23:44,890 AND THAT CLOSED IN MARCH AND 599 00:23:44,956 --> 00:23:46,391 THAT RECEIVED MORE THAN 200 600 00:23:46,458 --> 00:23:48,059 RESPONSES FROM A REALLY WIDE 601 00:23:48,126 --> 00:23:49,261 ARRAY OF PEOPLE FILLING THAT 602 00:23:49,327 --> 00:23:51,029 OUT. 603 00:23:51,096 --> 00:23:52,063 O.A.R. IS GOING TO CONTINUE TO 604 00:23:52,130 --> 00:23:54,499 GATHER AND SYNTHESIZE INPUT 605 00:23:54,566 --> 00:23:56,902 THROUGH OCTOBER 2024, AND THEN 606 00:23:56,968 --> 00:23:58,770 WE'LL DRAFT THE PLAN AND 607 00:23:58,837 --> 00:24:00,305 COORDINATE REVIEW WITH THE 608 00:24:00,372 --> 00:24:02,607 OARAC, AND ALSO ACROSS NIH, WITH 609 00:24:02,674 --> 00:24:04,075 THE ULTIMATE GOAL OF LAUNCHING 610 00:24:04,142 --> 00:24:05,744 THE NEW PLAN IN THE SUMMER OF 611 00:24:05,811 --> 00:24:08,079 2025. 612 00:24:08,146 --> 00:24:09,214 I THINK THAT WAS THE BIGGEST 613 00:24:09,281 --> 00:24:12,584 PART OF THE MEETING. 614 00:24:12,651 --> 00:24:14,085 THE MEETING ALSO CLOSED WITH 615 00:24:14,152 --> 00:24:14,753 UPDATES FROM THE ADVISORY 616 00:24:14,820 --> 00:24:16,855 COUNCILS ON THIS SLIDE, 617 00:24:16,922 --> 00:24:18,490 INCLUDING ARAC, AS WELL AS 618 00:24:18,557 --> 00:24:19,891 UPDATES FROM THE HIV CLINICAL 619 00:24:19,958 --> 00:24:21,226 GUIDELINES WORKING GROUPS, WHICH 620 00:24:21,293 --> 00:24:22,294 DEVELOPED THE CLINICAL 621 00:24:22,360 --> 00:24:24,062 GUIDELINES THAT MANY OF US HEERY 622 00:24:24,129 --> 00:24:28,233 LHERERELY ON AS CLINICAL 623 00:24:28,300 --> 00:24:29,000 PRACTITIONERS IN THE U.S. AND 624 00:24:29,067 --> 00:24:34,906 AROUND THE WORLD. 625 00:24:34,973 --> 00:24:36,408 SINCE THE LAST O.A.R. MEETING 626 00:24:36,474 --> 00:24:37,943 THERE HAVE BEEN SOME OTHER 627 00:24:38,009 --> 00:24:39,611 NOTABLE EVENTS TO HIGHLIGHT AND 628 00:24:39,678 --> 00:24:40,478 ADDITIONAL INFORMATION ON EACH 629 00:24:40,545 --> 00:24:42,380 OF THESE IS ALSO AVAILABLE ON 630 00:24:42,447 --> 00:24:43,548 THE O.A.R. WEBSITE. 631 00:24:43,615 --> 00:24:45,383 SO ON THE TOPMOST LEFT, IN 632 00:24:45,450 --> 00:24:46,551 MARCH, O.A.R. AND THE NIH OFFICE 633 00:24:46,618 --> 00:24:49,454 OF RESEARCH ON WOMEN'S HEALTH 634 00:24:49,521 --> 00:24:51,857 CO-SPONSORED A TWO-DAY VIRTUAL 635 00:24:51,923 --> 00:24:53,058 WORKSHOP THAT REVIEWED THE STATE 636 00:24:53,124 --> 00:24:56,461 OF SCIENCE ON HIV IN WOMEN AND 637 00:24:56,528 --> 00:24:57,729 THE GOAL WAS TO INFORM THE 638 00:24:57,796 --> 00:24:58,964 FUTURE RESEARCH AGENDA. 639 00:24:59,030 --> 00:25:00,799 THERE WERE A WIDE ARRAY OF 640 00:25:00,866 --> 00:25:02,367 TOPICS RELATED TO WOMEN, GIRLS 641 00:25:02,434 --> 00:25:03,969 AND GENDER-DIVERSE INDIVIDUALS. 642 00:25:04,035 --> 00:25:05,403 SESSIONS ALSO HIGHLIGHTED 643 00:25:05,470 --> 00:25:08,039 INTERVENTIONS AND CHALLENGES TO 644 00:25:08,106 --> 00:25:10,308 ADVANCING HEALTH EQUITY FOR 645 00:25:10,375 --> 00:25:11,309 WOMEN WITH AND WHO ARE AFFECTED 646 00:25:11,376 --> 00:25:12,310 BY HIV. 647 00:25:12,377 --> 00:25:14,946 IN APRIL ON THE TOP RIGHT, THE 648 00:25:15,013 --> 00:25:16,147 O.A.R. DIRECTOR'S SEMINAR WAS 649 00:25:16,214 --> 00:25:21,286 GIVEN BY DR. SARAH JIANELLA 650 00:25:21,353 --> 00:25:21,720 WEIBEL. 651 00:25:21,786 --> 00:25:23,922 HER TALK, THE LAST GIFT PROGRAM 652 00:25:23,989 --> 00:25:26,524 LESSONS LEARNED FROM ALTRUISTIC 653 00:25:26,591 --> 00:25:27,626 PARTICIPANTS ENROLLED IN HIV 654 00:25:27,692 --> 00:25:29,594 CURE RESEARCH AT THE END OF LIFE 655 00:25:29,661 --> 00:25:30,829 DISCUSSED HER PATH AS AN EARLY 656 00:25:30,896 --> 00:25:32,664 CAREER INVESTIGATOR IN AREAS 657 00:25:32,731 --> 00:25:34,733 SUCH AS HIV RESERVOIR, 658 00:25:34,799 --> 00:25:35,600 TRANSMISSION, COINFECTION AND 659 00:25:35,667 --> 00:25:37,402 ALSO INCLUDED SEX AND 660 00:25:37,469 --> 00:25:39,237 GENDER-RELATED ISSUES. 661 00:25:39,304 --> 00:25:40,338 ALSO IN APRIL, O.A.R. SPONSORED 662 00:25:40,405 --> 00:25:42,173 A HYBRID WORKSHOP DURING THE 663 00:25:42,240 --> 00:25:43,909 INTERNATIONAL WORKSHOP ON HIV 664 00:25:43,975 --> 00:25:44,442 AND WOMEN. 665 00:25:44,509 --> 00:25:46,978 AND THE WORKSHOP PROVIDED AN 666 00:25:47,045 --> 00:25:48,046 OPPORTUNITY FOR PARTNERS TO 667 00:25:48,113 --> 00:25:49,581 DISCUSS ISSUES, GAPS AND OTHER 668 00:25:49,648 --> 00:25:51,149 OPPORTUNITIES AGAIN FOCUSED ON 669 00:25:51,216 --> 00:25:52,017 IMPROVING THE LIVES OF WOMEN. 670 00:25:52,083 --> 00:25:55,053 AND FINALLY, O.A.R. HEARD ITS -- 671 00:25:55,120 --> 00:25:56,454 HELD ITS THIRD WORKSHOP FOR 672 00:25:56,521 --> 00:25:58,223 EARLY CAREER INVESTIGATORS IN 673 00:25:58,290 --> 00:25:59,124 HIV. 674 00:25:59,190 --> 00:26:01,326 FURTHERING EFFORTS TO CONTINUE 675 00:26:01,393 --> 00:26:02,560 TO SUPPORT AND PROVIDE KNOWLEDGE 676 00:26:02,627 --> 00:26:04,729 AND RESOURCES AND MENTORING TO 677 00:26:04,796 --> 00:26:05,697 THE UPCOMING GENERATION OF 678 00:26:05,764 --> 00:26:06,998 INVESTIGATORS. 679 00:26:07,065 --> 00:26:08,733 THERE WERE NEARLY 600 ATTENDEES 680 00:26:08,800 --> 00:26:09,901 FROM ACROSS THE WORLD, SO IT WAS 681 00:26:09,968 --> 00:26:19,778 A REALLY WELL-ATTENDED EVENT. 682 00:26:19,844 --> 00:26:21,212 THE O.A.R. WEBSITE POSTS 683 00:26:21,279 --> 00:26:22,247 RECORDINGS OF ALL THE MEETINGS 684 00:26:22,314 --> 00:26:23,415 AND THE NEXT ONE IS GOING TO BE 685 00:26:23,481 --> 00:26:25,150 HELD ON JUNE 20TH, 2024. 686 00:26:25,216 --> 00:26:26,618 IN ADDITION TO THE USUAL 687 00:26:26,685 --> 00:26:27,786 UPDATES, THAT MEETING IS GOING 688 00:26:27,852 --> 00:26:30,288 TO FEATURE A LOT OF TIME SPENT 689 00:26:30,355 --> 00:26:31,856 ON THE PROGRESS ON THE 690 00:26:31,923 --> 00:26:32,791 DEVELOPMENT OF THE NEXT 691 00:26:32,857 --> 00:26:34,359 STRATEGIC PLAN, REMARKS FROM THE 692 00:26:34,426 --> 00:26:35,360 NEW WHITE HOUSE OFFICE OF 693 00:26:35,427 --> 00:26:36,861 NATIONAL AIDS POLICY DIRECTOR, 694 00:26:36,928 --> 00:26:38,563 WHO WE WERE JUST INTRODUCED TO 695 00:26:38,630 --> 00:26:41,132 ON THE SCREEN BY 696 00:26:41,199 --> 00:26:42,734 DR. DIEFFENBACH, FRANCISCO RUIZ, 697 00:26:42,801 --> 00:26:45,870 AND A FOCUS ON ISSUES RELATED TO 698 00:26:45,937 --> 00:26:47,505 HIV CURE AND LONG TERM 699 00:26:47,572 --> 00:26:48,673 SURVIVORSHIP WITH PRESENTATIONS 700 00:26:48,740 --> 00:26:49,808 FROM BOTH INVESTIGATORS AS WELL 701 00:26:49,874 --> 00:26:51,109 AS COMMUNITY PERSPECTIVES. 702 00:26:51,176 --> 00:26:52,410 AND THE MEETING WILL BE 703 00:26:52,477 --> 00:26:52,677 VIDEOCAST. 704 00:26:52,744 --> 00:26:57,816 THANK YOU. 705 00:26:57,882 --> 00:27:00,318 I THINK I CAN ANSWER QUESTIONS. 706 00:27:00,385 --> 00:27:08,760 YES, I CAN ANSWER QUESTIONS. 707 00:27:08,827 --> 00:27:11,596 >> ANY QUESTIONS ONLINE? 708 00:27:11,663 --> 00:27:13,198 >> THANK YOU. 709 00:27:13,264 --> 00:27:16,167 >> THANK YOU VERY MUCH. 710 00:27:16,234 --> 00:27:16,501 OKAY. 711 00:27:16,568 --> 00:27:20,305 WE'RE GOING TO MOVE TO THE 712 00:27:20,372 --> 00:27:22,474 CONCEPT REVIEW AT THIS POINT. 713 00:27:22,540 --> 00:27:24,409 I'LL ASK ALL THE VOTING MEMBERS 714 00:27:24,476 --> 00:27:27,679 TO OPEN YOUR ELECTRONIC COUNCIL 715 00:27:27,746 --> 00:27:30,648 BOOK SO THAT YOU CAN VOTE AT THE 716 00:27:30,715 --> 00:27:34,586 END OF EACH CONCEPT OR, IN THIS 717 00:27:34,652 --> 00:27:37,922 CASE, AT THE END OF A, B AND C, 718 00:27:37,989 --> 00:27:41,593 AND I WILL KEEP REMINDING YOU TO 719 00:27:41,659 --> 00:27:42,360 VOTE REGULARLY THROUGHOUT THE 720 00:27:42,427 --> 00:27:44,763 REST OF THE MEETING. 721 00:27:44,829 --> 00:27:48,066 SO WE'RE GOING TO START WITH A 722 00:27:48,133 --> 00:27:49,667 PRESENTATION BY DIANE LAWRENCE 723 00:27:49,734 --> 00:27:51,503 FROM THE BASIC SCIENCE PROGRAM 724 00:27:51,569 --> 00:27:54,406 ON THE MARTIN DELANEY 725 00:27:54,472 --> 00:27:56,608 COLLABORATORIES FOR HIV CURE 726 00:27:56,674 --> 00:27:56,875 RESEARCH. 727 00:27:56,941 --> 00:27:57,909 ARE YOU GOING TO DO A TAG TEAM 728 00:27:57,976 --> 00:28:00,211 OR TAKE QUESTIONS IN BETWEEN? 729 00:28:00,278 --> 00:28:01,846 QUESTIONS IN BETWEEN. 730 00:28:01,913 --> 00:28:02,047 OKAY. 731 00:28:02,113 --> 00:28:02,947 >> YES. 732 00:28:03,014 --> 00:28:04,883 EXPWH 733 00:28:04,949 --> 00:28:06,117 >> SO WE'LL START WITH YOU AND 734 00:28:06,184 --> 00:28:06,885 THEN HAVE SOME QUESTIONS. 735 00:28:06,951 --> 00:28:07,452 GO AHEAD. 736 00:28:07,519 --> 00:28:11,923 >> THANK YOU VERY MUCH. 737 00:28:11,990 --> 00:28:13,658 AS SHE POINTED OUT, MY NAME IS 738 00:28:13,725 --> 00:28:14,459 DIANE LAWRENCE. 739 00:28:14,526 --> 00:28:15,860 I AM A PROGRAM OFFICER IN THE 740 00:28:15,927 --> 00:28:17,128 BASIC SCIENCE PROGRAM DIVISION 741 00:28:17,195 --> 00:28:18,930 OF AIDS AND I'M HERE WITH MY 742 00:28:18,997 --> 00:28:21,099 COLLEAGUE, TANIA LOMBO, FROM THE 743 00:28:21,166 --> 00:28:23,435 PREVENTION SCIENCES PROGRAM, AND 744 00:28:23,501 --> 00:28:24,269 WE'RE HERE TO REQUEST APPROVAL 745 00:28:24,335 --> 00:28:26,571 FOR A THREE-PART CONCEPT FOR THE 746 00:28:26,638 --> 00:28:28,106 MARTIN DELANEY COLLABORATORIES 747 00:28:28,173 --> 00:28:29,774 FOR HIV CURE RESEARCH. 748 00:28:29,841 --> 00:28:33,044 SO I'LL BE PRESENTING THE FIRST 749 00:28:33,111 --> 00:28:34,345 PART, AND TANIA WILL BE 750 00:28:34,412 --> 00:28:35,346 PRESENTING THE SECOND PART, AND 751 00:28:35,413 --> 00:28:39,184 THEN I'LL BE BACK TO PRESENT THE 752 00:28:39,250 --> 00:28:40,852 FINAL PART OF THE CONCEPT, AND 753 00:28:40,919 --> 00:28:43,755 WE'LL HAVE QUESTIONS AFTER EACH 754 00:28:43,822 --> 00:28:45,423 ONE AND THE OPPORTUNITY TO VOTE, 755 00:28:45,490 --> 00:28:48,259 I GUESS, AFTER EACH ONE. 756 00:28:48,326 --> 00:28:49,561 OKAY. 757 00:28:49,627 --> 00:28:50,028 INDEPENDENTLY? 758 00:28:50,095 --> 00:28:50,228 GREAT. 759 00:28:50,295 --> 00:28:51,329 SO I WILL GO AHEAD AND GET 760 00:28:51,396 --> 00:28:58,636 STARTED. 761 00:28:58,703 --> 00:29:01,606 SO THE FIRST PART IS THE 762 00:29:01,673 --> 00:29:03,041 CONCEPT -- WE'RE CALLING CONCEPT 763 00:29:03,108 --> 00:29:05,677 A, THE ADULT -- WE CALL IT 764 00:29:05,743 --> 00:29:07,645 INFORMALLY, THIS IS THE 765 00:29:07,712 --> 00:29:08,813 LONGEST-RUNNING PART OF THE 766 00:29:08,880 --> 00:29:11,349 COLLABORATORY PROGRAM. 767 00:29:11,416 --> 00:29:13,751 AND THE PURPOSE IS TO ACCELERATE 768 00:29:13,818 --> 00:29:14,953 INNOVATIVE, DYNAMIC AND HIGHLY 769 00:29:15,019 --> 00:29:16,621 COLLABORATIVE RESEARCH SPANNING 770 00:29:16,688 --> 00:29:17,255 BASIC, TRANSLATIONAL AND 771 00:29:17,322 --> 00:29:19,424 CLINICAL BUT NOT INCLUDING 772 00:29:19,491 --> 00:29:20,525 CLINICAL TRIALS THROUGH 773 00:29:20,592 --> 00:29:21,626 PARTNERSHIPS ACROSS ACADEMIA, 774 00:29:21,693 --> 00:29:23,161 INDUSTRY, GOVERNMENT, AND 775 00:29:23,228 --> 00:29:23,728 COMMUNITY. 776 00:29:23,795 --> 00:29:25,263 AND THE OVERALL GOAL IS TO 777 00:29:25,330 --> 00:29:29,200 DEVELOP EFFECTIVE STRATEGIES FOR 778 00:29:29,267 --> 00:29:31,035 ACHIEVING CONTROL OF HIV REBOUND 779 00:29:31,102 --> 00:29:33,671 IN THE ABSENCE OF ANTIRETROVIRAL 780 00:29:33,738 --> 00:29:35,306 TREATMENT OR THE ERADICATION OF 781 00:29:35,373 --> 00:29:37,509 HIV FROM THE BODY. 782 00:29:37,575 --> 00:29:39,043 THIS WILL BE A REISSUE. 783 00:29:39,110 --> 00:29:41,012 THIS WOULD BE OUR FOURTH 784 00:29:41,079 --> 00:29:44,816 ITERATION OF THE PROGRAM. 785 00:29:44,883 --> 00:29:46,618 AND AS IN THE PAST, WE WILL ONLY 786 00:29:46,684 --> 00:29:47,585 ALLOW NEW APPLICATIONS FOR THIS 787 00:29:47,652 --> 00:29:47,919 PROGRAM. 788 00:29:47,986 --> 00:29:49,787 SO WE'RE USING THE 789 00:29:49,854 --> 00:29:51,956 UM1 COOPERATIVE AGREEMENT 790 00:29:52,023 --> 00:29:53,491 MECHANISM, AND WE ANTICIPATE A 791 00:29:53,558 --> 00:29:55,894 FLAT BUDGET FOR THE PROGRAM SO 792 00:29:55,960 --> 00:29:58,096 WE EXPECT TO SUPPORT 7 TO 793 00:29:58,163 --> 00:30:01,065 8 AWARDS BASED ON THE CURRENT 794 00:30:01,132 --> 00:30:01,799 COSTS. 795 00:30:01,866 --> 00:30:02,667 JUST AS AN ESTIMATE. 796 00:30:02,734 --> 00:30:04,035 AND WE HOPE TO CONTINUE 797 00:30:04,102 --> 00:30:06,504 PARTNERING WITH SEVERAL OTHER 798 00:30:06,571 --> 00:30:07,505 NIH INSTITUTES ON THIS 799 00:30:07,572 --> 00:30:09,340 INITIATIVE, AND WE'VE ALSO BEGUN 800 00:30:09,407 --> 00:30:10,675 DISCUSSIONS WITH THE NATIONAL 801 00:30:10,742 --> 00:30:12,243 INSTITUTE ON AGING AS ANOTHER 802 00:30:12,310 --> 00:30:15,480 POTENTIAL PARTNER. 803 00:30:15,547 --> 00:30:18,783 SO WHY DO WE STILL NEED AN HIV 804 00:30:18,850 --> 00:30:21,152 CURE? 805 00:30:21,219 --> 00:30:23,354 AS OF THE LATEST UPDATES FROM UN 806 00:30:23,421 --> 00:30:25,790 AIDS, THERE ARE AN ESTIMATED 807 00:30:25,857 --> 00:30:26,558 39 MILLION PEOPLE WORLDWIDE 808 00:30:26,624 --> 00:30:30,562 LIVING WITH HIV. 809 00:30:30,628 --> 00:30:31,462 DESPITE SUBSTANTIAL GLOBAL 810 00:30:31,529 --> 00:30:32,764 INVESTMENT AND SUCCESSES IN HIV 811 00:30:32,830 --> 00:30:34,632 PREVENTION AND TREATMENT, NEW 812 00:30:34,699 --> 00:30:36,501 DIAGNOSES ARE STILL HAPPENING 813 00:30:36,568 --> 00:30:37,902 AND ARE RISING SHARPLY IN SOME 814 00:30:37,969 --> 00:30:41,739 PARTS OF THE WORLD. 815 00:30:41,806 --> 00:30:44,676 ALSO THERE ARE MORE THAN 816 00:30:44,742 --> 00:30:45,810 9 MILLION PEOPLE LIVING WITH HIV 817 00:30:45,877 --> 00:30:47,779 THAT DO NOT HAVE ACCESS TO 818 00:30:47,845 --> 00:30:48,646 ANTIRETROVIRAL TREATMENT SO 819 00:30:48,713 --> 00:30:51,382 FINDING WAYS TO ELIMINATE OR 820 00:30:51,449 --> 00:30:56,554 ERADICATE PERSISTENT HIV OR TO 821 00:30:56,621 --> 00:30:57,755 INTRODUCE LONG-TERM CONTROL 822 00:30:57,822 --> 00:30:59,924 WOULD REDUCE CO-MORBID ITS AND 823 00:30:59,991 --> 00:31:02,227 DEATHS AND RELIEVE THE BURDEN 824 00:31:02,293 --> 00:31:03,428 AND STIGMA ASSOCIATED WITH 825 00:31:03,494 --> 00:31:05,296 LIFELONG TREATMENT SO WE BELIEVE 826 00:31:05,363 --> 00:31:06,397 THIS WOULD BE A COMPONENT TO 827 00:31:06,464 --> 00:31:07,865 ENDING THE EPIDEMIC ONCE AR FOR 828 00:31:07,932 --> 00:31:08,533 ALL. 829 00:31:08,600 --> 00:31:10,001 SO THERE'S REASON TO HAVE HOPE 830 00:31:10,068 --> 00:31:14,239 THAT WE CAN ACHIEVE THIS GOAL. 831 00:31:14,305 --> 00:31:16,107 THERE ARE FIVE REPORTS SO FAR OF 832 00:31:16,174 --> 00:31:19,944 CURE BY -- INDIVIDUALS CURED BY 833 00:31:20,011 --> 00:31:20,812 ALLOGENEIC STEM CELL TRANSPLANT 834 00:31:20,878 --> 00:31:23,748 FOR CANCER TREATMENT AND 835 00:31:23,815 --> 00:31:24,616 MULTIPLE INDIVIDUALS WITH 836 00:31:24,682 --> 00:31:26,351 EVIDENCE OF NATURAL CONTROL OR 837 00:31:26,417 --> 00:31:27,151 POST-TREATMENT CONTROL IN THE 838 00:31:27,218 --> 00:31:30,054 ABSENCE OF A SPECIFIC CURE 839 00:31:30,121 --> 00:31:31,256 INTERVENTION. 840 00:31:31,322 --> 00:31:32,357 COMOWN SEVERAL GROUPS HAVE 841 00:31:32,423 --> 00:31:34,125 DEMONSTRATED STRATEGIES THAT 842 00:31:34,192 --> 00:31:37,929 DELAY VIRAL REBOUND FOLLOWING 843 00:31:37,996 --> 00:31:39,030 TREATMENT INTERRUPTION IN ANIMAL 844 00:31:39,097 --> 00:31:40,598 MODELS, BUT THERE'S BEEN LIMITED 845 00:31:40,665 --> 00:31:41,699 SUCCESS WITH CLINICAL 846 00:31:41,766 --> 00:31:42,567 INTERVENTIONS THAT EITHER 847 00:31:42,634 --> 00:31:44,202 CONTROL REBOUND OR SIGNIFICANTLY 848 00:31:44,269 --> 00:31:47,338 REDUCE THE REPLICATION COMPETENT 849 00:31:47,405 --> 00:31:48,439 RESERVOIR. 850 00:31:48,506 --> 00:31:50,308 SO THE SEARCH FOR AN EFFECTIVE 851 00:31:50,375 --> 00:31:51,743 CURE HAS BEEN INCREDIBLY 852 00:31:51,809 --> 00:31:54,045 COMPLEX, AN IN 2011, THE MARTIN 853 00:31:54,112 --> 00:31:54,846 DELANEY COLLABORATORY PROGRAM 854 00:31:54,912 --> 00:31:57,448 WAS DEVELOPED FOR EXACTLY THIS 855 00:31:57,515 --> 00:31:59,217 PURPOSE, BRINGING TOGETHER 856 00:31:59,284 --> 00:32:00,852 ACADEMIC RESEARCHERS, PRIVATE 857 00:32:00,918 --> 00:32:02,820 SECTOR PARTNERS, COMMUNITY 858 00:32:02,887 --> 00:32:03,921 PARTNERS AND GOVERNMENT. 859 00:32:03,988 --> 00:32:06,791 THE PROGRAM IS NAMED FOR MARTIN 860 00:32:06,858 --> 00:32:08,393 DELANEY, FOUNDER OF PROJECT 861 00:32:08,459 --> 00:32:11,029 INFORM AND OUTSPOKEN ADVOCATE 862 00:32:11,095 --> 00:32:12,130 FOR HIV RESEARCH. 863 00:32:12,196 --> 00:32:13,765 COLLABORATORIES HAVE GENERATED 864 00:32:13,831 --> 00:32:14,732 NEARLY 1300 RESEARCH 865 00:32:14,799 --> 00:32:15,867 PUBLICATIONS SINCE THE PROGRAM 866 00:32:15,933 --> 00:32:17,168 BEGAN. 867 00:32:17,235 --> 00:32:20,071 AND IT'S GROWN FROM THE ORIGINAL 868 00:32:20,138 --> 00:32:23,808 THREE COLLABORATORIES TO SIX IN 869 00:32:23,875 --> 00:32:27,011 2016 AND THEN WITH A THIRD 870 00:32:27,078 --> 00:32:29,113 ITERATION IN 2021, THERE WERE 10 871 00:32:29,180 --> 00:32:30,948 COLLABORATORIES FUNDED INCLUDING 872 00:32:31,015 --> 00:32:33,618 A NEW PEDIATRIC AWARD SHOWN ON 873 00:32:33,685 --> 00:32:34,118 THIS MAP. 874 00:32:34,185 --> 00:32:39,057 SO I WOULD NOTE THAT THE MAP IS 875 00:32:39,123 --> 00:32:40,725 SHOWING THE ADMINISTRATIVE HUB 876 00:32:40,792 --> 00:32:42,327 FOR THE AWARDS BUT COLLECTIVELY, 877 00:32:42,393 --> 00:32:44,128 THEY REPRESENT MORE THAN 300 878 00:32:44,195 --> 00:32:45,096 INDEPENDENT LABORATORIES FROM 879 00:32:45,163 --> 00:32:52,837 AROUND THE WORLD. 880 00:32:52,904 --> 00:32:54,872 THE CURRENT STRUCTURE INVOLVES 881 00:32:54,939 --> 00:32:56,140 FLEXIBLE DYNAMIC MILESTONE 882 00:32:56,207 --> 00:32:59,410 DRIVEN RESEARCH PLANS, I'LL TRY 883 00:32:59,477 --> 00:33:01,379 TO WALK YOU THROUGH THE FIRST 884 00:33:01,446 --> 00:33:03,915 RESEARCH FOCUS OR RF1 IS FOCUSED 885 00:33:03,981 --> 00:33:06,117 ON BASIC RESEARCH TO EXPAND 886 00:33:06,184 --> 00:33:08,086 KNOWLEDGE ABOUT PERSISTENT 887 00:33:08,152 --> 00:33:09,187 RESERVOIRS, REBOUND OR POST 888 00:33:09,253 --> 00:33:12,223 TREATMENT CONTROL. 889 00:33:12,290 --> 00:33:15,093 RF2 IS TRANSLATIONAL RESEARCH 890 00:33:15,159 --> 00:33:17,729 FOCUSED ON DURABLE HIV CONTROL 891 00:33:17,795 --> 00:33:21,866 STRATEGIES, AND THE THIRD IS 892 00:33:21,933 --> 00:33:22,867 TRANSLATIONAL STRATEGIES TO 893 00:33:22,934 --> 00:33:24,369 REDUCE THE RESERVOIR SIZE, 894 00:33:24,435 --> 00:33:26,704 EITHER BY ELIMINATION OR 895 00:33:26,771 --> 00:33:29,674 PERMANENT INACTIVATION. 896 00:33:29,741 --> 00:33:30,975 COLLABORATORY LEADERSHIP, THE 897 00:33:31,042 --> 00:33:32,510 LEADERS AND EXECUTIVE COMMITTEE 898 00:33:32,577 --> 00:33:35,947 DEVELOPED MILESTONES AND MAKE 899 00:33:36,013 --> 00:33:37,482 CRITICAL DECISIONS AS THE 900 00:33:37,548 --> 00:33:39,951 SCIENCE EVOLVES AND A SCIENTIFIC 901 00:33:40,017 --> 00:33:41,052 ADVISORY BOARD FOR EACH 902 00:33:41,119 --> 00:33:42,487 COLLABORATORY PROVIDES ANNUAL 903 00:33:42,553 --> 00:33:44,455 FEEDBACK ON PROGRESS AND 904 00:33:44,522 --> 00:33:45,156 PRIORITIES. 905 00:33:45,223 --> 00:33:46,424 AND BECAUSE THIS IS A 906 00:33:46,491 --> 00:33:47,959 COOPERATIVE AGREEMENT, THERE ARE 907 00:33:48,025 --> 00:33:55,400 SEVERAL NIH PROGRAM OFFICERS AND 908 00:33:55,466 --> 00:33:58,369 OTHER STAFF INVOLVED IN THE 909 00:33:58,436 --> 00:33:59,804 SCIENTIFIC AND OTHER ASPECTS OF 910 00:33:59,871 --> 00:34:00,238 THIS PROGRAM. 911 00:34:00,304 --> 00:34:01,539 THERE ARE LEADERS AND 912 00:34:01,606 --> 00:34:02,206 INVESTIGATORS INVOLVED IN EACH 913 00:34:02,273 --> 00:34:04,275 OF THE THREE RESEARCH FOCI, AND 914 00:34:04,342 --> 00:34:06,144 WE REQUIRE INVOLVEMENT OF AT 915 00:34:06,210 --> 00:34:08,112 LEAST ONE PRIVATE SECTOR PARTNER 916 00:34:08,179 --> 00:34:10,948 TO BE MATERIALLY AND 917 00:34:11,015 --> 00:34:12,483 INTELLECTUALLY INVOLVED IN EACH 918 00:34:12,550 --> 00:34:13,851 COLLABORATORY, AND WE ALSO 919 00:34:13,918 --> 00:34:16,254 REQUIRE A COMMUNITY ENGAGEMENT 920 00:34:16,320 --> 00:34:17,588 PLAN THAT INCLUDES COMMUNITY 921 00:34:17,655 --> 00:34:19,624 PARTNERS SUCH AS ADVOCATES AND 922 00:34:19,690 --> 00:34:22,794 COMMUNITY-BASED ORGANIZATIONS TO 923 00:34:22,860 --> 00:34:25,329 INCREASE CURE LITERACY, RESEARCH 924 00:34:25,396 --> 00:34:27,131 LITERACY, AS WELL AS A COMMUNITY 925 00:34:27,198 --> 00:34:28,065 ADVISORY BOARD TO PROVIDE 926 00:34:28,132 --> 00:34:29,634 FEEDBACK TO COLLABORATORY 927 00:34:29,700 --> 00:34:31,536 LEADERSHIP ADDRESSING, FOR 928 00:34:31,602 --> 00:34:37,975 EXAMPLE, SEPTEMBERABILITY AND A. 929 00:34:38,042 --> 00:34:39,811 EACH COLLABORATORY IS ENCOURAGED 930 00:34:39,877 --> 00:34:40,945 TO LEVERAGE OUTSIDE 931 00:34:41,012 --> 00:34:42,180 COLLABORATIONS AND RESOURCES, 932 00:34:42,246 --> 00:34:44,015 INCLUDING INDEPENDENT AND 933 00:34:44,081 --> 00:34:44,582 NETWORK CLINICAL TRIALS, AND 934 00:34:44,649 --> 00:34:46,451 OTHER FUNDED RESEARCH OR 935 00:34:46,517 --> 00:34:48,519 PROGRAMS FOR ACCESS TO 936 00:34:48,586 --> 00:34:50,188 BIOSPECIMENS, ANIMALS, AND 937 00:34:50,254 --> 00:34:55,860 TECHNOLOGY. 938 00:34:55,927 --> 00:34:57,195 THE PROGRAM HAS BROUGHT VALUE TO 939 00:34:57,261 --> 00:35:03,734 THE FIELD BY ENCOURAGING 940 00:35:03,801 --> 00:35:05,736 PARTNERSHIPS, LEVERAGING SHARED 941 00:35:05,803 --> 00:35:09,140 AND COMPLEMENTARY RESOURCES AND 942 00:35:09,207 --> 00:35:11,742 PIVOTING QUICKLY AS TECHNOLOGY 943 00:35:11,809 --> 00:35:11,976 EVOLVES. 944 00:35:12,043 --> 00:35:16,914 IT INCREASES RI CORE WITH 945 00:35:16,981 --> 00:35:18,716 COORDINATED EFFORTS TO DISSOLVE 946 00:35:18,783 --> 00:35:24,789 CYST KREP SEES IN THE FIELD. 947 00:35:24,856 --> 00:35:27,191 EVERY COLLABORATORY IS UNIQUE 948 00:35:27,258 --> 00:35:28,526 WITH THEIR OWN IDEAS, EXPERTISE 949 00:35:28,593 --> 00:35:29,827 AND PARTNERSHIPS. 950 00:35:29,894 --> 00:35:31,128 THERE'S REALLY NO WAY TO COVER 951 00:35:31,195 --> 00:35:33,231 ALL OF THE COLLABORATORIES IN 952 00:35:33,297 --> 00:35:34,665 ONE SHORT PRESENTATION HERE, SO 953 00:35:34,732 --> 00:35:36,734 JUST TO GIVE YOU AN EXAMPLE OF 954 00:35:36,801 --> 00:35:38,402 THE BREADTH OF RESEARCH BEING 955 00:35:38,469 --> 00:35:41,672 CARRIED OUT ACROSS THE PROGRAM, 956 00:35:41,739 --> 00:35:43,541 I'VE SHOWN HERE SEVERAL EXAMPLES 957 00:35:43,608 --> 00:35:44,942 OF HIGH-THROUGHPUT TECHNOLOGIES 958 00:35:45,009 --> 00:35:47,311 TO UNDERSTAND HIV RESERVOIR 959 00:35:47,378 --> 00:35:49,714 DYNAMICS IN BLOOD CELLS AND 960 00:35:49,780 --> 00:35:53,651 TISSUES, EPIGENETICS, CELL 961 00:35:53,718 --> 00:35:59,123 BIOLOGY -- AND IMPROVING IMMUNE 962 00:35:59,190 --> 00:35:59,390 CLEARANCE. 963 00:35:59,457 --> 00:36:02,293 AND LIPID NANOPARTICLE DELIVERY, 964 00:36:02,360 --> 00:36:03,728 GENOME EDITING AND CELL 965 00:36:03,794 --> 00:36:04,729 ENGINEERING APPROACHES. 966 00:36:04,795 --> 00:36:06,030 MANY COLLABORATORY INVESTIGATORS 967 00:36:06,097 --> 00:36:09,000 LINLEVERAGE A WIDE RANGE OF 968 00:36:09,066 --> 00:36:10,001 BIOSPECIMENS THROUGH THEIR 969 00:36:10,067 --> 00:36:10,968 INVOLVEMENT WITH CLINICAL 970 00:36:11,035 --> 00:36:14,038 COHORTS AND TRIALS SUCH AS ACTG, 971 00:36:14,105 --> 00:36:17,542 GATES FOUNDATION, AMFAR, AND 972 00:36:17,608 --> 00:36:18,643 INTERNATIONAL AND 973 00:36:18,709 --> 00:36:19,243 INDUSTRY-SPONSORED TRIALS AND 974 00:36:19,310 --> 00:36:20,611 THERE IS SUBSTANTIAL EFFORT 975 00:36:20,678 --> 00:36:22,079 ACROSS THE COLLABORATORIES TO 976 00:36:22,146 --> 00:36:23,147 COORDINATE ANIMAL AND HUMAN 977 00:36:23,214 --> 00:36:28,853 STUDIES. 978 00:36:28,920 --> 00:36:29,921 SOME HIGH LEVEL EXAMPLES OF 979 00:36:29,987 --> 00:36:31,489 RECENT FINDINGS THAT DEMONSTRATE 980 00:36:31,556 --> 00:36:32,723 THE ACCOMPLISHMENTS ACROSS ALL 981 00:36:32,790 --> 00:36:34,559 OF THE COLLABORATORIES ARE SHOWN 982 00:36:34,625 --> 00:36:36,093 HERE. 983 00:36:36,160 --> 00:36:37,628 FIRST MULTIPLE COLLABORATORIES 984 00:36:37,695 --> 00:36:39,497 HAVE IDENTIFIED DIFFERENT 985 00:36:39,564 --> 00:36:43,100 COMBINATION INTERVENTIONS THAT 986 00:36:43,167 --> 00:36:44,969 CONTROL VIRAL REBOUND AFTER ART 987 00:36:45,036 --> 00:36:46,170 INTERRUPTION IN DIFFERENT ANIMAL 988 00:36:46,237 --> 00:36:46,837 MODELS. 989 00:36:46,904 --> 00:36:47,805 TANIA WILL BE TALKING ABOUT ONE 990 00:36:47,872 --> 00:36:48,806 EXAMPLE OF THIS IN THE NEXT 991 00:36:48,873 --> 00:36:52,143 PRESENTATION. 992 00:36:52,209 --> 00:36:54,845 THEY'VE DEVELOPED NOVEL LATENCY 993 00:36:54,912 --> 00:36:59,450 REVERSAL APPROACHES INCLUDING 994 00:36:59,517 --> 00:37:02,386 DRUGS AND CRISPR SCREENING AND 995 00:37:02,453 --> 00:37:04,522 OTHER APPROACHES TO IDENTIFY 996 00:37:04,589 --> 00:37:07,158 MODULATORS AND MECHANISMS THAT 997 00:37:07,224 --> 00:37:09,560 REGULATE EXPRESSION OF LATENT 998 00:37:09,627 --> 00:37:12,630 HIV AND MAKE -- WITH 999 00:37:12,697 --> 00:37:13,931 REACTIVATION, MAKE RESERVOIR 1000 00:37:13,998 --> 00:37:15,700 CELLS MORE SUSCEPTIBLE TO 1001 00:37:15,766 --> 00:37:16,334 KILLING. 1002 00:37:16,400 --> 00:37:17,468 SEVERAL GROUPS HAVE COORDINATED 1003 00:37:17,535 --> 00:37:18,803 STUDIES TO COMPARE THE 1004 00:37:18,869 --> 00:37:21,005 PERFORMANCE AND SENSITIVITY AND 1005 00:37:21,072 --> 00:37:23,541 SPECIFICITY OF VARIOUS ASSAYS TO 1006 00:37:23,608 --> 00:37:25,176 QUANTIFY THE INTACT HIV 1007 00:37:25,242 --> 00:37:26,410 RESERVOIR, AND THEY'VE SHOWN 1008 00:37:26,477 --> 00:37:29,714 THAT VARIATIONS OF THE IPDA 1009 00:37:29,780 --> 00:37:31,082 ASSAY, FOR EXAMPLE, CAN BE USED 1010 00:37:31,148 --> 00:37:32,984 TO MEASURE SIV RESERVOIRS. 1011 00:37:33,050 --> 00:37:33,784 CURRENTLY SEVERAL LABS ARE 1012 00:37:33,851 --> 00:37:36,587 WORKING TO VALIDATE ASSAYS FOR 1013 00:37:36,654 --> 00:37:37,722 MEASURING DIFFERENT HIV 1014 00:37:37,788 --> 00:37:38,923 SUBTYPES. 1015 00:37:38,990 --> 00:37:41,325 AND FINALLY, AS SEVERAL OF THE 1016 00:37:41,392 --> 00:37:42,927 COLLABORATORIES ARE USING SINGLE 1017 00:37:42,994 --> 00:37:44,829 CELL MOTEOMICS APPROACHES IN 1018 00:37:44,895 --> 00:37:47,031 HUMANS AND ANIMAL MODELS TO 1019 00:37:47,098 --> 00:37:48,432 BETTER UNDERSTAND MECHANISMS 1020 00:37:48,499 --> 00:37:50,568 THAT DRIVES RESERVOIR EXPANSION 1021 00:37:50,635 --> 00:37:52,937 AND DECAY. 1022 00:37:53,004 --> 00:37:55,239 SO WE JUST REALLY WANT TO 1023 00:37:55,306 --> 00:37:56,240 EMPHASIZE, THESE ARE THINGS THAT 1024 00:37:56,307 --> 00:37:57,575 REALLY COULD NOT BE DONE WITHOUT 1025 00:37:57,642 --> 00:37:59,543 THE EXTENSIVE MULTIDISCIPLINARY 1026 00:37:59,610 --> 00:38:00,544 EXPERTISE WITHIN ALL OF THE 1027 00:38:00,611 --> 00:38:01,779 COLLABORATORIES. 1028 00:38:01,846 --> 00:38:03,280 AND AT THIS POINT, IT'S BECOME 1029 00:38:03,347 --> 00:38:04,382 CLEAR THAT COMBINATION 1030 00:38:04,448 --> 00:38:06,250 STRATEGIES WILL BE NEEDED FOR AN 1031 00:38:06,317 --> 00:38:08,919 EFFECTIVE CURE, SO IT WOULD BE 1032 00:38:08,986 --> 00:38:09,687 IMPORTANT TO CONTINUE THESE 1033 00:38:09,754 --> 00:38:12,089 EFFORTS. 1034 00:38:12,156 --> 00:38:16,594 SO OUR GOALS FOR REISSUE ARE TO 1035 00:38:16,661 --> 00:38:19,463 MAINTAIN THE CURRENT OVERALL 1036 00:38:19,530 --> 00:38:20,197 SCIENTIFIC AND MANAGEMENT 1037 00:38:20,264 --> 00:38:20,765 STRUCTURE WITHIN THE 1038 00:38:20,831 --> 00:38:21,732 COLLABORATORIES. 1039 00:38:21,799 --> 00:38:23,034 WE ANTICIPATE EACH WILL STILL 1040 00:38:23,100 --> 00:38:24,602 HAVE THREE RESEARCH FOCI WITH 1041 00:38:24,669 --> 00:38:26,570 BASIC AND TRANSLATIONAL GOALS, 1042 00:38:26,637 --> 00:38:28,673 AND IN THE FUTURE, WE'D LIKE TO 1043 00:38:28,739 --> 00:38:29,740 EMPHASIZE SYNERGY ACROSS THE 1044 00:38:29,807 --> 00:38:31,976 FOCUS AREAS AND DEVELOPMENT OF 1045 00:38:32,043 --> 00:38:33,077 STRATEGIES WITH THE GREATEST 1046 00:38:33,144 --> 00:38:34,478 PROMISE FOR FUTURE CLINICAL 1047 00:38:34,545 --> 00:38:37,581 DEVELOPMENT. 1048 00:38:37,648 --> 00:38:39,016 WE EXPECT TO HAVE GREATER 1049 00:38:39,083 --> 00:38:40,084 FLEXIBILITY IN THE SCIENTIFIC 1050 00:38:40,151 --> 00:38:42,153 OBJECTIVES OF THE RESEARCH FOCI, 1051 00:38:42,219 --> 00:38:43,287 SO EACH COLLABORATORY WILL HAVE 1052 00:38:43,354 --> 00:38:45,489 THE FREEDOM TO DECIDE WHETHER TO 1053 00:38:45,556 --> 00:38:47,992 FOCUS ON BOTH CONTROL AND 1054 00:38:48,059 --> 00:38:49,293 ERADICATION OR IF THEY'D LIKE TO 1055 00:38:49,360 --> 00:38:50,661 SPECIALIZE IN ONE OR THE OTHER, 1056 00:38:50,728 --> 00:38:52,296 DEPENDING ON THE TEAM'S UNIQUE 1057 00:38:52,363 --> 00:38:58,502 STRENGTHS AND CAPABILITIES. 1058 00:38:58,569 --> 00:39:01,739 BASED ON FEEDBACK FROM MULTIPLE 1059 00:39:01,806 --> 00:39:02,907 BOARDS, THE FUTURE PROGRAM WOULD 1060 00:39:02,973 --> 00:39:04,709 SUPPORT A ROBUST MODEL FOR 1061 00:39:04,775 --> 00:39:06,477 STRONG ACADEMIC COMMUNITY 1062 00:39:06,544 --> 00:39:07,778 PARTNERSHIPS, EMPHASIZING 1063 00:39:07,845 --> 00:39:09,513 COMMUNITY EDUCATION AND RESEARCH 1064 00:39:09,580 --> 00:39:11,816 LITERACY, AND RECOGNIZING THE 1065 00:39:11,882 --> 00:39:14,952 IMPORTANCE OF SOCIOBEHAVIORAL 1066 00:39:15,019 --> 00:39:15,686 RESEARCH ON THE ACCEPTABILITY 1067 00:39:15,753 --> 00:39:16,687 AND FEASIBILITY OF POTENTIAL 1068 00:39:16,754 --> 00:39:18,289 CURE STRATEGIES. 1069 00:39:18,355 --> 00:39:20,357 TO EXPAND HIV CURE RESEARCH TO A 1070 00:39:20,424 --> 00:39:21,559 MORE DIVERSE RANGE OF 1071 00:39:21,625 --> 00:39:23,594 PARTICIPANTS AND HIV SUBTYPES, 1072 00:39:23,661 --> 00:39:24,495 INTERNATIONAL PARTNERSHIPS WILL 1073 00:39:24,562 --> 00:39:26,030 BE STRONGLY ENCOURAGED, AND WE 1074 00:39:26,097 --> 00:39:27,565 PLAN TO ALLOW FOREIGN 1075 00:39:27,631 --> 00:39:34,105 APPLICATIONS FOR THE FIRST TIME. 1076 00:39:34,171 --> 00:39:36,173 WE WANT TO EXPAND INVOLVEMENT OF 1077 00:39:36,240 --> 00:39:37,007 EARLY CAREER INVESTIGATORS 1078 00:39:37,074 --> 00:39:37,875 ACROSS THE PROGRAM. 1079 00:39:37,942 --> 00:39:38,809 SEVERAL COLLABORATORIES ALREADY 1080 00:39:38,876 --> 00:39:40,077 DO A GREAT JOB OF THIS, BUT WE 1081 00:39:40,144 --> 00:39:42,713 WANT TO MAKE A MORE FORMAL 1082 00:39:42,780 --> 00:39:43,914 COMMITMENT TO SUPPORTING THE 1083 00:39:43,981 --> 00:39:45,249 NEXT GENERATION OF HIV CURE 1084 00:39:45,316 --> 00:39:45,583 RESEARCHERS. 1085 00:39:45,649 --> 00:39:47,852 AND FINALLY, WE WANT TO 1086 00:39:47,918 --> 00:39:49,520 FACILITATE COLLABORATION ACROSS 1087 00:39:49,587 --> 00:39:50,988 THE COLLABORATORY GROUPS THROUGH 1088 00:39:51,055 --> 00:39:52,523 A COORDINATION CENTER. 1089 00:39:52,590 --> 00:39:53,924 SO I'LL BE TALKING MORE ABOUT 1090 00:39:53,991 --> 00:39:55,826 THESE LAST TWO POINTS WHEN WE 1091 00:39:55,893 --> 00:39:59,897 GET TO CONCEPT C. 1092 00:39:59,964 --> 00:40:01,031 SO WE'RE VERY GRATEFUL FOR THE 1093 00:40:01,098 --> 00:40:05,770 REVIEW OF THIS CONCEPT BY RICH 1094 00:40:05,836 --> 00:40:14,578 D'AQUILA AND LE AND LOUIS SHACK. 1095 00:40:14,645 --> 00:40:16,013 THEY FELT THAT IT NOT ONLY 1096 00:40:16,080 --> 00:40:17,882 CONTRIBUTES TO THE HIV CURE 1097 00:40:17,948 --> 00:40:20,951 FIELD BUT ALSO IMPACTS AND IS 1098 00:40:21,018 --> 00:40:22,286 IMPACTED BY THE BROADER HIV 1099 00:40:22,353 --> 00:40:24,021 FIELD. 1100 00:40:24,088 --> 00:40:25,990 THEY ALSO NOTED THAT SINCE WE 1101 00:40:26,056 --> 00:40:27,658 HAVEN'T YET REACHED THE GOAL OF 1102 00:40:27,725 --> 00:40:29,693 FINDING A CURE AND WOULD BE 1103 00:40:29,760 --> 00:40:31,061 FURTHER BEHIND WITHOUT THIS 1104 00:40:31,128 --> 00:40:32,663 UNIQUE PROGRAM, CONTINUATION OF 1105 00:40:32,730 --> 00:40:33,764 THE COLLABORATORIES WAS 1106 00:40:33,831 --> 00:40:36,667 COMPELLING. 1107 00:40:36,734 --> 00:40:38,736 AS I INDICATED IN THE 1108 00:40:38,803 --> 00:40:40,271 PRESENTATION, WE PLAN TO 1109 00:40:40,337 --> 00:40:41,372 INCREASE FLEXIBILITY IN THE 1110 00:40:41,438 --> 00:40:44,475 RESEARCH FOCI. 1111 00:40:44,542 --> 00:40:47,745 THE SCIENTIFIC AREAS FOR 1112 00:40:47,812 --> 00:40:49,180 SPECIALIZATION AS A POSSIBILITY, 1113 00:40:49,246 --> 00:40:51,248 AND THE REVIEWERS FELT THAT 1114 00:40:51,315 --> 00:40:54,885 THFTION IMPORTANT. 1115 00:40:54,952 --> 00:40:55,186 THIS 1116 00:40:55,252 --> 00:40:55,553 WAS IMPORTANT. 1117 00:40:55,619 --> 00:40:56,754 AND THEY INDICATED THAT THEY 1118 00:40:56,821 --> 00:40:58,055 FELT THAT TRANSLATIONAL 1119 00:40:58,122 --> 00:41:00,057 POTENTIAL AND FEASIBILITY OF THE 1120 00:41:00,124 --> 00:41:01,592 PROPOSED INTERVENTIONS FOR 1121 00:41:01,659 --> 00:41:02,660 CLINICAL DEVELOPMENT IS 1122 00:41:02,726 --> 00:41:03,561 IMPORTANT AND SHOULD BE 1123 00:41:03,627 --> 00:41:04,662 CONSIDERED IN THE REVIEW 1124 00:41:04,728 --> 00:41:05,462 PROCESS. 1125 00:41:05,529 --> 00:41:07,164 SO WE PLAN TO INCORPORATE THIS 1126 00:41:07,231 --> 00:41:12,436 IN THE INITIATIVE. 1127 00:41:12,503 --> 00:41:14,305 THE REVIEWERS NOTED THAT 1128 00:41:14,371 --> 00:41:16,540 COMMUNITY EFFORTS SHOULD REALLY 1129 00:41:16,607 --> 00:41:17,708 EMPHASIZE EDUCATION AND 1130 00:41:17,775 --> 00:41:19,376 AWARENESS OF CURE RESEARCH, AND 1131 00:41:19,443 --> 00:41:21,879 WE AGREE AND I'VE INCORPORATED 1132 00:41:21,946 --> 00:41:23,314 THAT INTO THE PRESENTATION, AND 1133 00:41:23,380 --> 00:41:26,717 THEY SUGGESTED THAT FUTURE 1134 00:41:26,784 --> 00:41:28,586 COLLABORATORIES SHOULD FOCUS ON 1135 00:41:28,652 --> 00:41:29,787 THE COMBINATION APPROACHES AND 1136 00:41:29,854 --> 00:41:32,857 NOT DEPEND ON ANY PARTICULAR 1137 00:41:32,923 --> 00:41:33,324 CLASS OF INTERVENTION. 1138 00:41:33,390 --> 00:41:34,758 SO WE PLAN TO HIGHLIGHT THE NEED 1139 00:41:34,825 --> 00:41:38,462 FOR CONTINUED INNOVATION AND 1140 00:41:38,529 --> 00:41:39,263 DEVELOPING COMBINATION 1141 00:41:39,330 --> 00:41:39,563 STRATEGIES. 1142 00:41:39,630 --> 00:41:40,931 AND FINALLY, WE HAD SOME 1143 00:41:40,998 --> 00:41:42,633 DISCUSSION ABOUT HOW FURTHER 1144 00:41:42,700 --> 00:41:43,734 EXPANSION OF THE PROGRAM MAY NOT 1145 00:41:43,801 --> 00:41:45,936 BE HELPFUL, BUT THERE WAS 1146 00:41:46,003 --> 00:41:47,137 CONCERN THAT KEEPING THE NUMBER 1147 00:41:47,204 --> 00:41:48,806 OF COLLABORATORIES THE SAME 1148 00:41:48,873 --> 00:41:52,209 WOULD DISADVANTAGE NEW GROUPS. 1149 00:41:52,276 --> 00:41:53,878 SO I TRIED TO CLARIFY IN THE 1150 00:41:53,944 --> 00:41:56,280 PRESENTATION THAT WE DO NOT PLAN 1151 00:41:56,347 --> 00:41:59,016 TO ALLOW RENEWAL APPLICATIONS, 1152 00:41:59,083 --> 00:42:00,584 SIMILAR TO HOW WE'VE DONE IT IN 1153 00:42:00,651 --> 00:42:01,485 THE PAST. 1154 00:42:01,552 --> 00:42:03,654 WE FEEL THAT THIS ENCOURAGES NEW 1155 00:42:03,721 --> 00:42:05,122 AND EXISTING GROUPS TO BE ON A 1156 00:42:05,189 --> 00:42:09,493 LEVEL PLAYING FIELD. 1157 00:42:09,560 --> 00:42:11,028 AND THAT IS THE END, AND I'M 1158 00:42:11,095 --> 00:42:20,671 HAPPY TO TAKE ANY QUESTIONS. 1159 00:42:20,738 --> 00:42:26,043 >> ARE THERE ANY QUESTIONS? 1160 00:42:26,110 --> 00:42:28,112 >> THANKS, THAT'S REAL EXCITING. 1161 00:42:28,178 --> 00:42:29,947 SO JUST TO -- 1162 00:42:30,014 --> 00:42:33,017 >> IF YOU INTRODUCE YOURSELF? 1163 00:42:33,083 --> 00:42:37,788 >> KEITH JEROME FROM SEATTLE. 1164 00:42:37,855 --> 00:42:41,692 TO PARAPHRASE THE KIND OF THREE 1165 00:42:41,759 --> 00:42:44,161 RESEARCH FOCI THAT YOU 1166 00:42:44,228 --> 00:42:45,229 DESCRIBED, THERE'S A BASIC 1167 00:42:45,296 --> 00:42:46,597 SCIENCE COMPONENT, TRANSLATIONAL 1168 00:42:46,664 --> 00:42:47,631 FOR CONTROL OF THE RESERVOIR, 1169 00:42:47,698 --> 00:42:49,166 CONTROL OF REBOUND, THIRD ONE 1170 00:42:49,233 --> 00:42:50,301 BEING CONTROL OF REBOUND -- 1171 00:42:50,367 --> 00:42:51,268 >> THE CURRENT ONES, YES. 1172 00:42:51,335 --> 00:42:53,904 >> -- CURRENTLY, AND SO IT 1173 00:42:53,971 --> 00:42:55,372 WASN'T CLEAR TO ME, ARE THOSE 1174 00:42:55,439 --> 00:42:56,907 GOING TO BE CALLED OUT AGAIN IN 1175 00:42:56,974 --> 00:42:59,310 THE NEW RFA AS SUCH, OR ARE 1176 00:42:59,376 --> 00:43:01,979 THOSE JUST THREE AREAS OF 1177 00:43:02,046 --> 00:43:04,381 POTENTIAL RESEARCH BECAUSE 1178 00:43:04,448 --> 00:43:06,784 YOU'RE WANTING TO GIVE GROUPS 1179 00:43:06,850 --> 00:43:11,455 FLEXIBILITY AND THE ABILITY TO 1180 00:43:11,522 --> 00:43:14,024 SPECIALIZE WHICH I REALLY LIKE, 1181 00:43:14,091 --> 00:43:17,461 HOW WILL YOU DIRECT -- REVIEW 1182 00:43:17,528 --> 00:43:19,863 BASICALLY TO PUT A SPECIALIZED 1183 00:43:19,930 --> 00:43:21,098 COLLABORATORY ON SORT OF AN EVEN 1184 00:43:21,165 --> 00:43:23,534 PLAYING FIELD WITH A MORE 1185 00:43:23,600 --> 00:43:28,439 BROADLY DIRECTED ONE? 1186 00:43:28,505 --> 00:43:32,910 >> SO FIRST OF ALL, I THINK 1187 00:43:32,977 --> 00:43:34,278 WE -- THERE'S DETAILS THAT WILL 1188 00:43:34,345 --> 00:43:35,179 BE MORE CLEAR WHEN THE 1189 00:43:35,245 --> 00:43:37,214 INITIATIVE COMES OUT BUT AT THIS 1190 00:43:37,281 --> 00:43:38,415 POINT WE FEEL THE IMPORTANCE OF 1191 00:43:38,482 --> 00:43:39,783 BOTH BASIC SCIENCE AND 1192 00:43:39,850 --> 00:43:43,721 TRANSLATIONAL RESEARCH, AND JUST 1193 00:43:43,787 --> 00:43:45,222 IF I UNDERSTAND YOUR LAST 1194 00:43:45,289 --> 00:43:47,458 QUESTION, SO IF THERE'S AN 1195 00:43:47,524 --> 00:43:48,158 EXISTING PROGRAM WHO WOULD BE 1196 00:43:48,225 --> 00:43:50,094 APPLYING IN THE FUTURE, THEY 1197 00:43:50,160 --> 00:43:51,562 WOULD NEED TO ADHERE TO THE NEW 1198 00:43:51,628 --> 00:43:52,096 STRUCTURE. 1199 00:43:52,162 --> 00:43:54,665 SO WHATEVER THAT STRUCTURE MAY 1200 00:43:54,732 --> 00:43:54,832 BE. 1201 00:43:54,898 --> 00:43:56,500 >> I THINK I WASN'T SUPER CLEAR. 1202 00:43:56,567 --> 00:43:57,601 >> OH, SORRY. 1203 00:43:57,668 --> 00:44:01,105 >> SO EVERYBODY IS NEW, SO NEW 1204 00:44:01,171 --> 00:44:04,408 COLLABORATORY A MIGHT BE VERY 1205 00:44:04,475 --> 00:44:06,844 MUCH FOCUSED ON CONTROL OF 1206 00:44:06,910 --> 00:44:09,213 REBOUND, JUST AS AN EXAMPLE. 1207 00:44:09,279 --> 00:44:10,381 ANOTHER ONE MIGHT BE MORE 1208 00:44:10,447 --> 00:44:10,881 BROAD-BASED. 1209 00:44:10,948 --> 00:44:12,182 WE HAVE SORT OF THE THREE THINGS 1210 00:44:12,249 --> 00:44:15,552 THAT YOU MENTIONED. 1211 00:44:15,619 --> 00:44:18,756 SO I JUST AM CURIOUS AS TO HOW 1212 00:44:18,822 --> 00:44:19,923 YOU WILL PRESENT THIS OR 1213 00:44:19,990 --> 00:44:20,924 ENCOURAGE YOU TO BE THOUGHTFUL 1214 00:44:20,991 --> 00:44:22,292 ABOUT HOW YOU PRESENT THIS TO 1215 00:44:22,359 --> 00:44:25,662 REVIEW PANELS SO THAT A FOCUSED 1216 00:44:25,729 --> 00:44:28,699 COLLABORATORY MIGHT BE COMPETING 1217 00:44:28,766 --> 00:44:30,367 ON A LEVEL PLAYING FIELD WITH 1218 00:44:30,434 --> 00:44:33,804 ONE THAT IS MORE BROADLY 1219 00:44:33,871 --> 00:44:34,238 DIRECTED. 1220 00:44:34,304 --> 00:44:38,609 DOES THAT MAKE SENSE, THAT FOCUS 1221 00:44:38,675 --> 00:44:41,278 VERSUS BREADTH IN HOW YOU ENSURE 1222 00:44:41,345 --> 00:44:42,212 AN EVEN REVIEW PROCESS. 1223 00:44:42,279 --> 00:44:42,813 >> RIGHT. 1224 00:44:42,880 --> 00:44:44,148 WELL, I THINK ALL OF THEM WOULD 1225 00:44:44,214 --> 00:44:48,719 NEED TO SHOW THE CAPACITY FOR 1226 00:44:48,786 --> 00:44:49,620 FUTURE CLINICAL DEVELOPMENT, ALL 1227 00:44:49,686 --> 00:44:51,488 OF THEM WOULD NEED TO SHOW 1228 00:44:51,555 --> 00:44:53,590 SYNERGY AMONG THEIR BASIC AND 1229 00:44:53,657 --> 00:44:55,159 TRANSLATIONAL EFFORTS. 1230 00:44:55,225 --> 00:44:57,795 I THINK ALL OF THEM WILL NEED TO 1231 00:44:57,861 --> 00:44:59,797 SHOW, AS THEY'VE DONE IN THE 1232 00:44:59,863 --> 00:45:03,934 PAST, ADAPTABILITY TO CHANGING 1233 00:45:04,001 --> 00:45:05,469 SCIENCE, SO I THINK OVERALL THE 1234 00:45:05,536 --> 00:45:08,405 GOAL IS TO FIND AN AVENUE 1235 00:45:08,472 --> 00:45:11,809 TOWARDS A CURE. 1236 00:45:11,875 --> 00:45:16,213 SO I THINK HOW THEY DO THAT WILL 1237 00:45:16,280 --> 00:45:20,350 LIKELY NEED TO REMAIN SIMILAR IN 1238 00:45:20,417 --> 00:45:24,688 TERMS OF FOCI TO ENHANCE BASIC 1239 00:45:24,755 --> 00:45:25,789 SCIENCE AND BETTER UNDERSTANDING 1240 00:45:25,856 --> 00:45:27,391 ABOUT THE RESERVOIRS, AND 1241 00:45:27,458 --> 00:45:29,493 TRANSLATIONAL APPROACHES THAT 1242 00:45:29,560 --> 00:45:32,096 WILL ADDRESS EITHER CURE -- 1243 00:45:32,162 --> 00:45:33,363 SORRY -- EITHER CONTROL OR 1244 00:45:33,430 --> 00:45:35,766 ERADICATION OR BOTH. 1245 00:45:35,833 --> 00:45:37,968 AND HOWEVER THEY CHOOSE TO 1246 00:45:38,035 --> 00:45:40,070 PRESENT THAT, I THINK THE 1247 00:45:40,137 --> 00:45:43,440 REVIEWERS ULTIMATELY WILL BE 1248 00:45:43,507 --> 00:45:46,076 LOOKING AT THE OVERALL 1249 00:45:46,143 --> 00:45:48,645 INSTRUCTIONS FOR THE PROGRAM. 1250 00:45:48,712 --> 00:45:49,980 SO CARL, DID YOU WANT TO HAVE 1251 00:45:50,047 --> 00:45:51,081 ANOTHER COMMENT THERE? 1252 00:45:51,148 --> 00:45:53,016 >> I'D JUST POINT OUT THAT WE 1253 00:45:53,083 --> 00:45:54,451 HAVE A CALL WITH REVIEWERS 1254 00:45:54,518 --> 00:45:55,319 BEFOREHAND, SO WE'LL MAKE IT 1255 00:45:55,385 --> 00:45:56,920 CLEAR TO THEM THAT ALL 1256 00:45:56,987 --> 00:45:58,222 APPLICATIONS SHOULD BE REVIEWED 1257 00:45:58,288 --> 00:45:59,723 ON THEIR OWN MERIT, WHETHER 1258 00:45:59,790 --> 00:46:01,258 THEY'RE SPECIALIZED IN ONE AREA 1259 00:46:01,325 --> 00:46:07,297 OR IF THEY'RE BROAD-BASED. 1260 00:46:07,364 --> 00:46:10,367 >> HI, SEEMA SHAH. 1261 00:46:10,434 --> 00:46:12,002 SO I JUST WANTED TO BUILD ON 1262 00:46:12,069 --> 00:46:15,339 THAT BECAUSE I THINK IT WOULD BE 1263 00:46:15,405 --> 00:46:18,942 REALLY IMPORTANT IN THAT CALL TO 1264 00:46:19,009 --> 00:46:22,980 BE CLEAR TO REVIEWERS THE 1265 00:46:23,046 --> 00:46:24,414 POTENTIAL REVIEW OF BROAD 1266 00:46:24,481 --> 00:46:25,048 APPLICATIONS, I THINK WHAT YOU 1267 00:46:25,115 --> 00:46:26,083 WERE SUGGESTING. 1268 00:46:26,150 --> 00:46:27,317 BUT I THINK A LOT OF TIMES 1269 00:46:27,384 --> 00:46:31,788 REVIEW COMMITTEES TEND TO -- YOU 1270 00:46:31,855 --> 00:46:32,656 KNOW, SAYING SOMETHING IS VAGUE 1271 00:46:32,723 --> 00:46:34,358 OR UNCLEAR OR THERE ISN'T 1272 00:46:34,424 --> 00:46:35,459 SUPPORT FOR A CERTAIN STRATEGY 1273 00:46:35,526 --> 00:46:39,696 IS AN EASY CRITIQUE, AND I THINK 1274 00:46:39,763 --> 00:46:43,467 FOCUSED -- TEND TO DO BETTER SO 1275 00:46:43,534 --> 00:46:45,369 IF THERE'S REALLY THIS EMPHASIS 1276 00:46:45,435 --> 00:46:47,304 ON WANTING TO FUND BROAD 1277 00:46:47,371 --> 00:46:48,672 ADAPTABLE STRATEGIES, IT MAY BE 1278 00:46:48,739 --> 00:46:49,773 IMPORTANT TO EMPHASIZE THAT. 1279 00:46:49,840 --> 00:46:51,141 SO I JUST WANTED TO UNDERSCORE 1280 00:46:51,208 --> 00:46:57,047 WHAT YOU WERE SAYING AND -- IF 1281 00:46:57,114 --> 00:46:57,614 THAT -- 1282 00:46:57,681 --> 00:46:59,883 >> GENERALLY, I THINK WE WERE 1283 00:46:59,950 --> 00:47:01,385 EXPRESSING THE SAME CONCERNS, 1284 00:47:01,451 --> 00:47:03,420 ALTHOUGH I THINK MINE WAS SORT 1285 00:47:03,487 --> 00:47:05,289 OF ON OPPOSITE SIDE OF THE FENCE 1286 00:47:05,355 --> 00:47:09,326 THERE ACTUALLY. 1287 00:47:09,393 --> 00:47:11,862 THIS PARTICULAR MECHANISM HAS 1288 00:47:11,929 --> 00:47:15,332 FAVORED THE BIGGEST, BROADEST 1289 00:47:15,399 --> 00:47:16,833 GROUP OF PEOPLE DOING EVERYTHING 1290 00:47:16,900 --> 00:47:20,704 YOU CAN DO. 1291 00:47:20,771 --> 00:47:22,506 AND THAT MAY BE A VERY VALID WAY 1292 00:47:22,573 --> 00:47:23,106 TO DO THINGS. 1293 00:47:23,173 --> 00:47:26,810 IT PROBABLY IS NOT THE ONLY WAY. 1294 00:47:26,877 --> 00:47:28,645 SO I THINK THAT AS A PROGRAM, A 1295 00:47:28,712 --> 00:47:30,214 DIVERSITY OF APPROACHES, WE 1296 00:47:30,280 --> 00:47:31,748 DON'T KNOW HOW TO CURE THIS 1297 00:47:31,815 --> 00:47:34,051 VIRUS, SO I THINK DIVERSITY OF 1298 00:47:34,117 --> 00:47:35,152 APPROACH IS ACTUALLY IMPORTANT. 1299 00:47:35,219 --> 00:47:35,852 >> RIGHT. 1300 00:47:35,919 --> 00:47:37,354 I'M HOPING THAT BY THE TIME WE 1301 00:47:37,421 --> 00:47:40,324 GET TO CONCEPT C, YOU COULD SEE 1302 00:47:40,390 --> 00:47:42,559 HOW THERE WOULD BE A POTENTIAL 1303 00:47:42,626 --> 00:47:44,661 FOR COORDINATION OF DIFFERENT 1304 00:47:44,728 --> 00:47:48,665 GROUPS THAT MIGHT HAVE 1305 00:47:48,732 --> 00:47:49,766 COMPLEMENTARY BUT MORE 1306 00:47:49,833 --> 00:47:50,834 SPECIALIZED APPROACHES AS WELL 1307 00:47:50,901 --> 00:47:52,703 AS THE MORE BROAD. 1308 00:47:52,769 --> 00:47:53,937 >> QUICK SEPARATE QUESTION. 1309 00:47:54,004 --> 00:47:54,338 >> YES. 1310 00:47:54,404 --> 00:47:56,707 >> FOR THE FOREIGN APPLICATIONS, 1311 00:47:56,773 --> 00:47:58,675 WOULD THEY BE STANDALONE FOREIGN 1312 00:47:58,742 --> 00:48:00,077 APPLICATIONS OR IS THE IDEA THAT 1313 00:48:00,143 --> 00:48:03,180 IT WOULD BE -- COULD IT BE 1314 00:48:03,247 --> 00:48:05,616 ENTIRELY FOREIGN OR -- 1315 00:48:05,682 --> 00:48:06,817 COLLABORATING WITH U.S.-BASED 1316 00:48:06,883 --> 00:48:07,484 SITES? 1317 00:48:07,551 --> 00:48:13,156 >> I THINK WE WOULD BE OPEN TO 1318 00:48:13,223 --> 00:48:14,091 MULTIPLE POSSIBILITIES THERE. 1319 00:48:14,157 --> 00:48:15,058 SO AS LONG AS THE SCIENTIFIC 1320 00:48:15,125 --> 00:48:17,261 MERIT IS WHAT IT NEED TO BE AND, 1321 00:48:17,327 --> 00:48:19,229 YOU KNOW, ALL OF THESE PROGRAMS 1322 00:48:19,296 --> 00:48:21,698 ARE VERY COLLABORATIVE AND MANY 1323 00:48:21,765 --> 00:48:23,333 ALREADY INCLUDE FOREIGN 1324 00:48:23,400 --> 00:48:24,001 COLLABORATIONS. 1325 00:48:24,067 --> 00:48:27,504 SO -- BUT WE'VE NEVER ALLOWED A 1326 00:48:27,571 --> 00:48:29,740 FOREIGN APPLICATION COMING IN 1327 00:48:29,806 --> 00:48:30,907 BEFORE, SO ANYWAY, YEAH. 1328 00:48:30,974 --> 00:48:31,708 >> THANK YOU. 1329 00:48:31,775 --> 00:48:32,142 >> GREAT. 1330 00:48:32,209 --> 00:48:37,848 THANK YOU. 1331 00:48:37,914 --> 00:48:39,249 >> ARE THERE ANY QUESTIONS 1332 00:48:39,316 --> 00:48:39,850 ONLINE? 1333 00:48:39,916 --> 00:48:40,884 YOU GUYS CAN ASK QUESTIONS IF 1334 00:48:40,951 --> 00:48:41,685 YOU'D LIKE. 1335 00:48:41,752 --> 00:48:43,720 >> YES, I HAVE A QUESTION. 1336 00:48:43,787 --> 00:48:53,897 HI, THIS IS CINDY DE DERDEYN, 1337 00:48:53,964 --> 00:48:56,400 UNIVERSITY OF WASHINGTON, 1338 00:48:56,466 --> 00:48:57,167 SEATTLE. 1339 00:48:57,234 --> 00:48:58,135 TO ENCOURAGE PEOPLE PUTTING IN 1340 00:48:58,201 --> 00:48:59,870 THESE APPLICATIONS TO FOCUS ON 1341 00:48:59,936 --> 00:49:01,238 THE LIMITATIONS OF THE ANIMAL 1342 00:49:01,305 --> 00:49:04,207 MODELS AND DO SOME COMPARATIVE 1343 00:49:04,274 --> 00:49:06,176 STUDIES, YOU KNOW, A LOT OF 1344 00:49:06,243 --> 00:49:08,545 THESE -- I FEEL LIKE IT'S GOTTEN 1345 00:49:08,612 --> 00:49:09,846 VERY NARROW IN TERMS OF, YOU 1346 00:49:09,913 --> 00:49:17,354 KNOW, USING THE BARCODED SIV AND 1347 00:49:17,421 --> 00:49:18,522 THESE SHORT WINDOWS BEFORE ART 1348 00:49:18,588 --> 00:49:22,993 IS INITIATED, AND THAT IT'S 1349 00:49:23,060 --> 00:49:24,294 COMING OUT THAT THERE REALLY ARE 1350 00:49:24,361 --> 00:49:25,562 DIFFERENCES BETWEEN THESE 1351 00:49:25,629 --> 00:49:27,664 RESERVOIRS AND SIV IN THE ANIMAL 1352 00:49:27,731 --> 00:49:30,400 MODELS AND PEOPLE IN REAL LIFE 1353 00:49:30,467 --> 00:49:32,469 WHO ARE ON TREATMENT AND MAY 1354 00:49:32,536 --> 00:49:33,870 HAVE BEEN INFECTED FOR YEARS 1355 00:49:33,937 --> 00:49:35,372 BEFORE THEY WENT ON TREATMENT. 1356 00:49:35,439 --> 00:49:37,574 SO I WONDER IF THIS WAS AN 1357 00:49:37,641 --> 00:49:39,142 OPPORTUNITY TO HAVE THAT BE A 1358 00:49:39,209 --> 00:49:44,448 FOCUS OR A FEATURE OR A PRIORITY 1359 00:49:44,514 --> 00:49:46,083 OF SOME OF THESE COLLABORATORIES 1360 00:49:46,149 --> 00:49:46,917 TO BETTER UNDERSTAND WHAT ARE 1361 00:49:46,983 --> 00:49:48,618 THE LIMITATIONS OF THE ANIMAL 1362 00:49:48,685 --> 00:49:50,253 MODELS, AND HOW DO MAKE THEM 1363 00:49:50,320 --> 00:49:52,789 MORE TRANSLATABLE. 1364 00:49:52,856 --> 00:49:54,024 >> ABSOLUTELY. 1365 00:49:54,091 --> 00:49:54,891 I THINK THAT WOULD BE AN 1366 00:49:54,958 --> 00:49:55,926 EXCELLENT -- THANK YOU FOR 1367 00:49:55,992 --> 00:49:57,527 BRINGING THAT UP. 1368 00:49:57,594 --> 00:50:04,201 THE GOAL IS TO MOVE TOWARDS A 1369 00:50:04,267 --> 00:50:05,702 CLINICAL CURE, SO I THINK 1370 00:50:05,769 --> 00:50:06,703 DEFINITELY THAT THIS CERTAINLY 1371 00:50:06,770 --> 00:50:10,407 WOULD BE A GREAT OPPORTUNITY TO 1372 00:50:10,474 --> 00:50:13,143 HAVE DIFFERENT GROUPS LOOKING AT 1373 00:50:13,210 --> 00:50:19,015 DIFFERENT MODELS AND WAYS TO 1374 00:50:19,082 --> 00:50:19,850 DEMONSTRATE THE PRELIMINARY 1375 00:50:19,916 --> 00:50:22,919 STUDIES THAT COULD BE MOST 1376 00:50:22,986 --> 00:50:24,221 PROMISING TOWARDS A CLINICAL 1377 00:50:24,287 --> 00:50:27,624 STRATEGY. 1378 00:50:27,691 --> 00:50:29,092 >> I BELIEVE THERE'S ONE LAST 1379 00:50:29,159 --> 00:50:29,726 QUESTION ONLINE. 1380 00:50:29,793 --> 00:50:31,261 THEN WE'RE GOING TO HAVE TO MOVE 1381 00:50:31,328 --> 00:50:31,428 ON. 1382 00:50:31,495 --> 00:50:36,299 >> YES, THIS IS TIM HENRICH FROM 1383 00:50:36,366 --> 00:50:36,600 UCSF. 1384 00:50:36,666 --> 00:50:39,436 I THINK ONE OF THE REAL 1385 00:50:39,503 --> 00:50:40,837 STRENGTHS OF THE DELANEY 1386 00:50:40,904 --> 00:50:41,905 COLLABORATORIES IS REALLY THE 1387 00:50:41,972 --> 00:50:44,107 FLEXIBILITY TO ADAPT TO DATA 1388 00:50:44,174 --> 00:50:45,742 THAT'S GENERATED TO HAVE A GROUP 1389 00:50:45,809 --> 00:50:48,378 THAT CAN RAPIDLY RESPOND WITHOUT 1390 00:50:48,445 --> 00:50:50,814 HAVING TO BE FOCUSED ON TOO MANY 1391 00:50:50,881 --> 00:50:52,582 SPECIFIC PROJECT OUTCOMES AND 1392 00:50:52,649 --> 00:50:53,683 PEOPLE HAVE THAT FLEXIBILITY. 1393 00:50:53,750 --> 00:50:56,686 BUT I ALSO WONDERED, YOU KNOW, I 1394 00:50:56,753 --> 00:50:59,189 GUESS FOR HISTORICAL OBVIOUS 1395 00:50:59,256 --> 00:51:00,891 REASONS THAT ELIMINATING 1396 00:51:00,957 --> 00:51:03,160 CLINICAL TRIALS WITHIN THE 1397 00:51:03,226 --> 00:51:04,361 GEOCOLLABORATORIES NOT JUST FOR 1398 00:51:04,428 --> 00:51:05,929 FUNDING ISSUES BUT REGULATORY 1399 00:51:05,996 --> 00:51:07,497 AND OTHER ISSUES, BUT WHETHER 1400 00:51:07,564 --> 00:51:09,900 THERE'S A WAY TO CHALLENGE A 1401 00:51:09,966 --> 00:51:11,968 RELATIVELY STRICT POLICY OF NOT 1402 00:51:12,035 --> 00:51:13,170 HAVING CLINICAL TRIALS OUTSIDE 1403 00:51:13,236 --> 00:51:15,005 OF SPECIFIC MECHANISMS TO DO 1404 00:51:15,071 --> 00:51:17,607 SMALLER PATHOGENESIS, WHETHER 1405 00:51:17,674 --> 00:51:19,709 THEY INVOLVE APIs OR OTHER 1406 00:51:19,776 --> 00:51:21,344 TYPES OF QUESTIONS THAT ACTUALLY 1407 00:51:21,411 --> 00:51:23,580 MAY BE IMPORTANT WHEN LOOKING AT 1408 00:51:23,647 --> 00:51:25,182 THESE PATHOBIOLOGICAL MECHANISMS 1409 00:51:25,248 --> 00:51:26,583 ON A SMALLER SCALE. 1410 00:51:26,650 --> 00:51:28,952 NOT FOR A LARGE CLINICAL TRIAL, 1411 00:51:29,019 --> 00:51:31,955 BUT WONDERING IF THAT COULD ALSO 1412 00:51:32,022 --> 00:51:33,957 BE A COMPONENT GOING FORWARD ON 1413 00:51:34,024 --> 00:51:35,225 SOME OF THESE CLINICAL 1414 00:51:35,292 --> 00:51:35,692 COLLABORATORIES. 1415 00:51:35,759 --> 00:51:36,560 >> AS FAR AS PILOT STUDIES? 1416 00:51:36,626 --> 00:51:37,828 IS THAT WHAT YOU'RE SUGGESTING? 1417 00:51:37,894 --> 00:51:40,297 >> YES, KIND OF SMALLER PILOT 1418 00:51:40,363 --> 00:51:42,699 STUDIES THAT ARE NOT 1419 00:51:42,766 --> 00:51:43,600 AGENCY-DEFINED INTERVENTIONS. 1420 00:51:43,667 --> 00:51:45,302 >> YEAH, I MEAN, WE'VE 1421 00:51:45,368 --> 00:51:47,237 DEFINITELY BEEN DISCUSSING THAT 1422 00:51:47,304 --> 00:51:49,706 QUITE A BIT AS FAR AS HOW TO 1423 00:51:49,773 --> 00:51:53,443 SUPPORT SUCH SMALL PILOT STUDIES 1424 00:51:53,510 --> 00:51:55,178 AND SOME OF MY COLLEAGUES HERE 1425 00:51:55,245 --> 00:51:56,613 MIGHT WISH TO ANSWER THAT 1426 00:51:56,680 --> 00:51:59,449 POTENTIALLY BUT WE DEFINITELY 1427 00:51:59,516 --> 00:52:01,184 ARE LOOKING AT A POSSIBLE WAY TO 1428 00:52:01,251 --> 00:52:04,020 SUPPORT THOSE TYPES OF STUDIES. 1429 00:52:04,087 --> 00:52:06,556 >> TIM, THIS IS CARL. 1430 00:52:06,623 --> 00:52:08,592 I'D JUST MAKE THE POINT THAT WE 1431 00:52:08,658 --> 00:52:11,328 WORKED WITH ACTG TO HAVE 1432 00:52:11,394 --> 00:52:12,529 SPECIFIC SOLICITATION TO 1433 00:52:12,596 --> 00:52:13,530 ACCOMMODATE SMALL CLINICAL 1434 00:52:13,597 --> 00:52:13,763 TRIALS. 1435 00:52:13,830 --> 00:52:15,031 WE FOUND IN THE SECOND ITERATION 1436 00:52:15,098 --> 00:52:16,600 WHEN WE ALLOWED CLINICAL TRIALS 1437 00:52:16,666 --> 00:52:18,435 IT WAS REALLY A BIG DISTRACTION 1438 00:52:18,502 --> 00:52:19,769 TO TRY TO SQUEEZE A CLINICAL 1439 00:52:19,836 --> 00:52:21,471 TRIAL INTO THE FIVE-YEAR FUNDING 1440 00:52:21,538 --> 00:52:22,506 PLAN OF THE COLLABORATORY, SO IT 1441 00:52:22,572 --> 00:52:24,808 WAS A BIG DISTRACTION 1442 00:52:24,875 --> 00:52:25,709 FINANCIALLY AS WELL AS JUST THE 1443 00:52:25,775 --> 00:52:26,710 ATTENTION FROM THE SCIENCE TO 1444 00:52:26,776 --> 00:52:28,745 JUST THE LOGISTICS OF CARRYING 1445 00:52:28,812 --> 00:52:29,513 OUT CLINICAL TRIALS. 1446 00:52:29,579 --> 00:52:31,047 SO THE FEEDBACK WE RECEIVED WHEN 1447 00:52:31,114 --> 00:52:35,385 WE DID AN EVALUATION FROM AN 1448 00:52:35,452 --> 00:52:36,353 INDEPENDENT GROUP WAS THAT IT'S 1449 00:52:36,419 --> 00:52:41,258 PROBABLY BEST TO CONTINUE THAT. 1450 00:52:41,324 --> 00:52:42,225 THOSE TRIALS ARE BEST DONE 1451 00:52:42,292 --> 00:52:43,460 OUTSIDE THE COLLABORATORY 1452 00:52:43,527 --> 00:52:46,329 STRUCTURE UNDER SEPARATE FUND 1453 00:52:46,396 --> 00:52:47,397 FUNDING. 1454 00:52:47,464 --> 00:52:49,199 >> SO I THINK WE'LL MOVE ON TO 1455 00:52:49,266 --> 00:52:51,735 THE NEXT PRESENTATION, AND IF 1456 00:52:51,801 --> 00:52:55,205 YOU CAN EITHER VOTE NOW OR WAIT 1457 00:52:55,272 --> 00:53:04,648 UNTIL WE'VE DONE ALL THREE. 1458 00:53:04,714 --> 00:53:07,751 >> MY NAME IS TANIA LOMBO, 1459 00:53:07,817 --> 00:53:08,618 PROGRAM OFFICER AT THE 1460 00:53:08,685 --> 00:53:11,588 PREVENTION SCIENCES PROGRAM. 1461 00:53:11,655 --> 00:53:14,824 TO PRESENT CONCEPT B INITIATIVE 1462 00:53:14,891 --> 00:53:16,960 FOR APPROVAL TITLED MART TIN 1463 00:53:17,027 --> 00:53:18,161 DELANEY COLLABORATORIES FOR 1464 00:53:18,228 --> 00:53:20,897 PEDIATRIC HIV CURE RESEARCH. 1465 00:53:20,964 --> 00:53:22,098 THE PURPOSE OF THIS INITIATIVE 1466 00:53:22,165 --> 00:53:24,167 WILL BE TO ACCELERATE RESEARCH 1467 00:53:24,234 --> 00:53:26,102 TO ADDRESS MAJOR OBSTACLES TO 1468 00:53:26,169 --> 00:53:28,605 THE ERADICATION OF HIV INFECTION 1469 00:53:28,672 --> 00:53:31,007 OR LONG-TERM ART-FREE CONTROL OF 1470 00:53:31,074 --> 00:53:32,742 VIRAL REBOUND IN PEDIATRIC 1471 00:53:32,809 --> 00:53:36,746 INDIVIDUAL LIVING WITH HIV. 1472 00:53:36,813 --> 00:53:39,282 THIS INITIATIVE WILL FOSTER A 1473 00:53:39,349 --> 00:53:41,251 COLLABORATIVE AND DYNAMIC 1474 00:53:41,318 --> 00:53:42,619 PROGRAM STRUCTURE, LEVERAGING 1475 00:53:42,686 --> 00:53:45,488 SHARED RESOURCES, FACILITATING 1476 00:53:45,555 --> 00:53:46,990 COLLABORATIONS AMONG ACADEMIA, 1477 00:53:47,057 --> 00:53:49,259 INDUSTRY, GOVERNMENT, AND 1478 00:53:49,326 --> 00:53:51,127 COMMUNITY, WHILE TRAINING THE 1479 00:53:51,194 --> 00:53:52,662 NEXT GENERATION OF PEDIATRIC HIV 1480 00:53:52,729 --> 00:53:55,365 CURE RESEARCHERS. 1481 00:53:55,432 --> 00:53:56,833 THIS IS A REISSUE, AND THE PLAN 1482 00:53:56,900 --> 00:53:59,369 IS TO USE THE UM1 GRANT 1483 00:53:59,436 --> 00:53:59,703 MECHANISM. 1484 00:53:59,769 --> 00:54:02,906 WE HAD ANTICIPATED ONE AWARD, 1485 00:54:02,973 --> 00:54:04,374 AND HERE YOU CAN SEE OUR 1486 00:54:04,441 --> 00:54:05,675 POTENTIAL CO-FUNDING PARTNERS 1487 00:54:05,742 --> 00:54:11,247 WITHIN NIH. 1488 00:54:11,314 --> 00:54:14,317 FROM THE 2023 REPORT, WE KNOW 1489 00:54:14,384 --> 00:54:16,653 FROM THE GLOBAL POPULATION, 1490 00:54:16,720 --> 00:54:18,288 LIVING WITH HIV, AN ALARMING 1491 00:54:18,355 --> 00:54:20,557 NUMBER OF 1.5 MILLION CHILDREN 1492 00:54:20,624 --> 00:54:22,759 LIVE WITH THIS VIRUS. 1493 00:54:22,826 --> 00:54:27,464 AND ONLY 57% RECEIVE 1494 00:54:27,530 --> 00:54:28,865 ANTIRETROVIRAL TREATMENT. 1495 00:54:28,932 --> 00:54:32,335 THIS REALITY AND PARTICULAR 1496 00:54:32,402 --> 00:54:34,170 CONSIDERATIONS PROMPTED US TO 1497 00:54:34,237 --> 00:54:36,406 INITIATE A SEPARATE 1498 00:54:36,473 --> 00:54:37,507 COLLABORATORY SOLELY DEDICATED 1499 00:54:37,574 --> 00:54:40,710 TO PEDIATRIC POPULATIONS. 1500 00:54:40,777 --> 00:54:42,245 BEFORE I COME TO THOSE DETAILS, 1501 00:54:42,312 --> 00:54:45,382 I WANT TO REVIEW WITH YOU SOME 1502 00:54:45,448 --> 00:54:46,616 UNIQUE IMMUNOLOGIC 1503 00:54:46,683 --> 00:54:47,751 CONSIDERATIONS FOR PEDIATRIC HIV 1504 00:54:47,817 --> 00:54:51,588 CURE RESEARCH. 1505 00:54:51,655 --> 00:54:54,824 SO WE KNOW THE IMMUNOLOGIC 1506 00:54:54,891 --> 00:54:56,326 ENVIRONMENT OF THE FETUS IN 1507 00:54:56,393 --> 00:54:58,928 UTERO IS ANTI-INFLAMMATORY WITH 1508 00:54:58,995 --> 00:55:00,664 POTENTIAL IMPLICATIONS FOR 1509 00:55:00,730 --> 00:55:03,600 RESERVOIR SIZE AND STABILITY. 1510 00:55:03,667 --> 00:55:04,067 THE ANTI-INFLAMMATORY 1511 00:55:04,134 --> 00:55:06,770 ENVIRONMENT PROMOTES LOW IMMUNE 1512 00:55:06,836 --> 00:55:09,706 ACTIVATION, AND LOW EXPIRATION 1513 00:55:09,773 --> 00:55:14,277 EXPRESSIONOF CCR5. 1514 00:55:14,344 --> 00:55:16,279 AS IS SHOWN IN THIS PICTURE, AND 1515 00:55:16,346 --> 00:55:18,381 THIS SLIDE, THE TIMING OF 1516 00:55:18,448 --> 00:55:20,450 EXPOSURE IS KNOWN, SO THE 1517 00:55:20,517 --> 00:55:22,886 PERINATAL HIV INFECTION ALLOWS A 1518 00:55:22,952 --> 00:55:25,689 RAPID ART INITIATION. 1519 00:55:25,755 --> 00:55:27,857 USUALLY BETWEEN THE 48 HOURS OF 1520 00:55:27,924 --> 00:55:30,694 LIFE TO 3 MONTHS OF AGE. 1521 00:55:30,760 --> 00:55:33,396 AND THIS IS PROVIDING AN 1522 00:55:33,463 --> 00:55:34,597 OPPORTUNITY, A WINDOW OF 1523 00:55:34,664 --> 00:55:36,032 OPPORTUNITY TO INTERVENE VERY 1524 00:55:36,099 --> 00:55:38,935 EARLY IN THE COURSE OF INFECT 1525 00:55:39,002 --> 00:55:42,372 INFECTION. 1526 00:55:42,439 --> 00:55:43,640 FROM THE VIROLOGIC 1527 00:55:43,707 --> 00:55:45,108 CONSIDERATIONS, WE KNOW THERE IS 1528 00:55:45,175 --> 00:55:46,242 A DIFFERENT DISTRIBUTION OF CELL 1529 00:55:46,309 --> 00:55:47,677 TYPES CONTAINING THE HIV 1530 00:55:47,744 --> 00:55:54,517 RESERVOIR COMPARED TO ADULTS. 1531 00:55:54,584 --> 00:55:56,720 WE KNOW FROM EARLY TREATMENT 1532 00:55:56,786 --> 00:55:58,988 STUDIES THAT THE RESERVOIRS IN 1533 00:55:59,055 --> 00:56:01,458 CHILDREN ARE GENERALLY SMALLER, 1534 00:56:01,524 --> 00:56:04,094 MORE HOMOGENEOUS, AND THE 1535 00:56:04,160 --> 00:56:06,296 RESERVOIR HAS A FASTER DECAY, 1536 00:56:06,362 --> 00:56:08,098 AND IN PARTICULAR, THERE IS A 1537 00:56:08,164 --> 00:56:09,599 MINIMAL CENTRAL NERVOUS SYSTEM 1538 00:56:09,666 --> 00:56:12,569 RESERVOIR. 1539 00:56:12,635 --> 00:56:16,506 HERE I'M LISTING A FEW CASES OF 1540 00:56:16,573 --> 00:56:17,907 ART 3 REMISSION THAT HAVE BEEN 1541 00:56:17,974 --> 00:56:19,976 REPORTED IN PERINATAL INFECTIONS 1542 00:56:20,043 --> 00:56:25,582 SUCH AS THE MISSISSIPPI BABY, 1543 00:56:25,648 --> 00:56:27,584 FRENCH PERINATAL COHORT CHILD 1544 00:56:27,650 --> 00:56:30,453 STUDY AN THE SOUTH AFRICAN CHILD 1545 00:56:30,520 --> 00:56:33,389 STUDY. 1546 00:56:33,456 --> 00:56:36,126 SHOWING VERY EARLY ART IN 1547 00:56:36,192 --> 00:56:41,131 NEONATES WITH IN UTERO HIV SHOW 1548 00:56:41,197 --> 00:56:44,400 REDUCED VIRAL RESERVOIRS AND 1549 00:56:44,467 --> 00:56:46,803 ENABLED MORE THAN 48 WEEK 1550 00:56:46,870 --> 00:56:49,939 ART-FREE REMISSION IN 1551 00:56:50,006 --> 00:56:51,808 4 PARTICIPANTS. 1552 00:56:51,875 --> 00:56:52,609 PRACTICAL EXAMPLES JUSTIFY THE 1553 00:56:52,675 --> 00:56:54,511 NEED OF A HIGHLY COORDINATED 1554 00:56:54,577 --> 00:56:56,679 RESEARCH EFFORTS TO FIND AN HIV 1555 00:56:56,746 --> 00:56:58,014 CURE FOR CHILDREN LIVING WITH 1556 00:56:58,081 --> 00:56:59,315 HIV. 1557 00:56:59,382 --> 00:57:02,485 SO OUR INSTITUTE RESPO RESPONDEO 1558 00:57:02,552 --> 00:57:05,522 THIS NEED BY AWARDING IN 2021 1559 00:57:05,588 --> 00:57:12,829 THE FIRST PEDIATRIC MDC 1560 00:57:12,896 --> 00:57:14,998 COLLABORATORY. 1561 00:57:15,064 --> 00:57:16,733 IT FUNCTIONS MAINLY UNDER THE 1562 00:57:16,800 --> 00:57:18,168 SAME PREMISE AS THE ADULT 1563 00:57:18,234 --> 00:57:19,702 COUNTERPART WITH A FEW 1564 00:57:19,769 --> 00:57:21,237 DIFFERENCES. 1565 00:57:21,304 --> 00:57:23,173 THIS GROUP IS HIGHLY 1566 00:57:23,239 --> 00:57:25,241 INTEGRATIVE, COLLABORATIVE AND 1567 00:57:25,308 --> 00:57:26,442 SYNERGISTIC, AND WORKING VERY 1568 00:57:26,509 --> 00:57:31,447 ACTIVE ON BUILDIN BUILDING STRAC 1569 00:57:31,514 --> 00:57:32,682 PARTNERSHIPS WITH OTHER 1570 00:57:32,749 --> 00:57:33,750 COLLABORATORIES, OTHER NETWORKS 1571 00:57:33,817 --> 00:57:35,118 AND OTHER STAKEHOLDERS TO 1572 00:57:35,185 --> 00:57:36,553 DELIVERY SOURCES AND TO BUILD 1573 00:57:36,619 --> 00:57:40,256 EFFECTIVE PARTNERSHIPS. 1574 00:57:40,323 --> 00:57:42,659 THE PEDIATRIC MDC HAS AN EXTRA 1575 00:57:42,725 --> 00:57:44,160 FOCUS AS YOU SEE IN THE FIGURE 1576 00:57:44,227 --> 00:57:47,063 HERE, RESEARCH FOCUS 4, 1577 00:57:47,130 --> 00:57:48,832 DEDICATED TO ASSAY DEVELOPMENT 1578 00:57:48,898 --> 00:57:50,466 OPTIMIZATION AND IMAGING. 1579 00:57:50,533 --> 00:57:52,602 AND AS A REMINDER, THE MAIN 1580 00:57:52,669 --> 00:57:53,503 OBJECTIVE OF THIS COLLABORATORY 1581 00:57:53,570 --> 00:57:56,573 IS TO ACHIEVE AND SUSTAIN 1582 00:57:56,639 --> 00:57:58,408 ART-TREE CONTROL OF HIV 1583 00:57:58,474 --> 00:58:01,344 REPLICATION IN PEDIATRIC 1584 00:58:01,411 --> 00:58:02,512 POPULATIONS. 1585 00:58:02,579 --> 00:58:04,848 THE NEXT SLIDE THAT I WANT TO 1586 00:58:04,914 --> 00:58:07,784 REVIEW WITH YOU A FEW SCIENTIFIC 1587 00:58:07,851 --> 00:58:08,418 ACCOMPLISHMENTS AND INTERESTING 1588 00:58:08,484 --> 00:58:14,991 PROGRESS OF THIS COLLABORATORY. 1589 00:58:15,058 --> 00:58:16,726 SO JUST TO REMIND EVERYONE, THE 1590 00:58:16,793 --> 00:58:18,895 COLLABORATORY IS PART OF THE 1591 00:58:18,962 --> 00:58:23,399 LARGER AILDZ AIDS MDC PROGRAM. 1592 00:58:23,466 --> 00:58:24,100 FOR THESE FOUR EXAMPLES, I WANT 1593 00:58:24,167 --> 00:58:25,401 TO BRING YOUR ATTENTION TO THE 1594 00:58:25,468 --> 00:58:26,436 FIRST ONE WHERE THE RESEARCHERS 1595 00:58:26,502 --> 00:58:29,739 ARE USING EARLY ART COUPLED WITH 1596 00:58:29,806 --> 00:58:32,709 AAV-VECTORED DELIVERY OF ECD4-IG 1597 00:58:32,775 --> 00:58:36,412 AND 10-1074. 1598 00:58:36,479 --> 00:58:38,615 THEY HAVE FOUND SUBSTANTIAL 1599 00:58:38,681 --> 00:58:41,885 DELAYED VIRUS REBOUND IN 1600 00:58:41,951 --> 00:58:44,287 PERINATALLY SHIV-INFECTED INFANT 1601 00:58:44,354 --> 00:58:48,424 MACAQUES FOLLOWING A ATI. 1602 00:58:48,491 --> 00:58:49,525 ANOTHER GROUP IS LOOKING AT 1603 00:58:49,592 --> 00:58:52,762 EARLY LIFE INNATE IMMUNE SEX 1604 00:58:52,829 --> 00:58:53,930 DIFFERENCES SELECTIVELY 1605 00:58:53,997 --> 00:58:55,465 INFLUENCE VERTICAL HIV 1606 00:58:55,531 --> 00:58:57,000 TRANSMISSION AND MODULATE 1607 00:58:57,066 --> 00:58:57,567 POST-TREATMENT CONTROL IN 1608 00:58:57,634 --> 00:58:59,969 CHILDREN. 1609 00:59:00,036 --> 00:59:02,238 SOME PRELIMINARY ANALYSES OF 1610 00:59:02,305 --> 00:59:03,907 HOST GENETIC AND IMMUNE MARKERS 1611 00:59:03,973 --> 00:59:07,710 HAVE IDENTIFIED POTENTIAL HOST 1612 00:59:07,777 --> 00:59:08,778 IMMUNOGENETIC FACTORS 1613 00:59:08,845 --> 00:59:09,812 CONTRIBUTING TO VIRAL CONTROL, 1614 00:59:09,879 --> 00:59:12,482 AND FINALLY, ONE OF OUR GROUPS 1615 00:59:12,548 --> 00:59:15,084 IN SOUTH AFRICA IS LEADING UP A 1616 00:59:15,151 --> 00:59:15,985 COLLABORATIVE PROJECT TO 1617 00:59:16,052 --> 00:59:17,921 UNDERSTAND THE MECHANISMS AND 1618 00:59:17,987 --> 00:59:20,857 CELL SOURCES OF HIV PERSISTENCE 1619 00:59:20,924 --> 00:59:24,694 IN CSF AND ITS IMPLICATIONS IN 1620 00:59:24,761 --> 00:59:25,929 NEUROPATHOGENESIS AND 1621 00:59:25,995 --> 00:59:36,472 CONSEQUENCES TO CNS INFECTION. 1622 00:59:36,539 --> 00:59:42,145 I WANT TO SHOW MAIN RESULTS IN 1623 00:59:42,211 --> 00:59:47,116 AAV-DRIVEN EXPRESSION OF ECD4-IG 1624 00:59:47,183 --> 00:59:52,922 AND 10-1074, 7 OUT OF 10 1625 00:59:52,989 --> 00:59:57,193 AAV-TREATED INFANT MACAQUES 1626 00:59:57,260 --> 00:59:58,928 REMAINED AVIREMIC FOR MORE THAN 1627 00:59:58,995 --> 01:00:00,363 30 WEEKS AFTER ATI. 1628 01:00:00,430 --> 01:00:03,266 THE PERSISTENCE OF MONOCLONAL 1629 01:00:03,333 --> 01:00:08,004 ANTIBANTIBODIES IN THE RED DOTSS 1630 01:00:08,071 --> 01:00:09,706 SUPPRESSED IN THE CONTEXT OF THE 1631 01:00:09,772 --> 01:00:10,373 ANTIBODY EXPRESSION. 1632 01:00:10,440 --> 01:00:12,241 SO THE BOTTOM LINE OF THESE 1633 01:00:12,308 --> 01:00:13,176 RESULTS ARE SHOWING THAT THERE 1634 01:00:13,242 --> 01:00:15,745 IS A CLEAR CORRELATION BETWEEN 1635 01:00:15,812 --> 01:00:16,980 THE EXPRESSION OF THE ANTIBODIES 1636 01:00:17,046 --> 01:00:18,314 AND THE VIRUS SUPPRESSION. 1637 01:00:18,381 --> 01:00:19,983 THIS IS A VERY PROMISING STORY 1638 01:00:20,049 --> 01:00:22,051 COMING FROM THE PEDIATRIC MDC, 1639 01:00:22,118 --> 01:00:26,189 AND CURRENTLY OUR RESEARCH IS 1640 01:00:26,255 --> 01:00:27,523 EVALUATING PATHS TO MOVE TO 1641 01:00:27,590 --> 01:00:33,696 CLINICAL EVALUATION. 1642 01:00:33,763 --> 01:00:36,232 LAST BUT NOT LEAST, THE FIRST 1643 01:00:36,299 --> 01:00:37,667 COLLABORATORY IS HIGHLY FOCUSED 1644 01:00:37,734 --> 01:00:45,408 ON BRINGING -- THEY ARE WORKING 1645 01:00:45,475 --> 01:00:45,942 ON DIFFERENT FRONTS. 1646 01:00:46,009 --> 01:00:47,276 FIRST THEY ARE OPTIMIZING 1647 01:00:47,343 --> 01:00:49,679 STRATEGIES TO REACH NEW 1648 01:00:49,746 --> 01:00:52,181 STAKEHOLDERS, AND DEVELOPMENT OF 1649 01:00:52,248 --> 01:00:58,254 RESEARCH LITERACY MATERIALS, 1650 01:00:58,321 --> 01:00:59,455 SUPPORT KNOWLEDGE DISSEMINATION 1651 01:00:59,522 --> 01:01:01,090 INVOLVING VOICES OF PEDIATRIC 1652 01:01:01,157 --> 01:01:02,725 HIV CURE, IN THIS WAY, TO ENABLE 1653 01:01:02,792 --> 01:01:04,994 COMMUNITY PARTICIPATION AND 1654 01:01:05,061 --> 01:01:06,763 DISCUSSIONS TO SHAPE THE 1655 01:01:06,829 --> 01:01:09,599 PEDIATRIC CURE AGENDA. 1656 01:01:09,665 --> 01:01:13,636 SO MOVING FORWARD, WHEN WE ARE 1657 01:01:13,703 --> 01:01:16,606 LOOKING ON THE REISSUE OF THIS 1658 01:01:16,672 --> 01:01:18,307 PEDIATRIC MDC AS PART OF THE 1659 01:01:18,374 --> 01:01:19,642 GLOBAL PROGRAM, WE WANT TO BUILD 1660 01:01:19,709 --> 01:01:21,511 ON THE CURRENT FRAMEWORK 1661 01:01:21,577 --> 01:01:22,178 ALLOWING GREATER FLEXIBILITY 1662 01:01:22,245 --> 01:01:26,649 WITHIN THE RESEARCH FOCI, IN 1663 01:01:26,716 --> 01:01:28,051 PARTICULAR FOR THE PEDIATRIC, WE 1664 01:01:28,117 --> 01:01:32,188 ARE LOOKING TO STIMULATE CERTAIN 1665 01:01:32,255 --> 01:01:34,023 AREAS AS DESCRIBED IN THESE 1666 01:01:34,090 --> 01:01:35,558 BULLET POINTS. 1667 01:01:35,625 --> 01:01:37,193 FIRST, CHARACTERIZATION OF THE 1668 01:01:37,260 --> 01:01:39,162 RESERVOIR LATENCY AND DYNAMICS 1669 01:01:39,228 --> 01:01:39,996 ACROSS DEVELOPMENTAL STAGES 1670 01:01:40,063 --> 01:01:41,097 INCLUDING DIFFICULT TO ACCESS 1671 01:01:41,164 --> 01:01:44,167 TISSUES SUCH AS CNS. 1672 01:01:44,233 --> 01:01:47,870 SECOND, THE FUTURE PEDIATRIC MDC 1673 01:01:47,937 --> 01:01:49,072 WILL EXPAND ON TAILORED 1674 01:01:49,138 --> 01:01:51,374 STRATEGIES FOR PEDIATRIC HIV 1675 01:01:51,441 --> 01:01:52,975 RESERVOIR, AND KEEP THE 1676 01:01:53,042 --> 01:01:53,810 DEVELOPMENT OF SPECIALIZED AND 1677 01:01:53,876 --> 01:01:56,079 NEW TOOLS IN VITRO AND OTHER 1678 01:01:56,145 --> 01:01:58,247 MODELS, ASSAYS, IMAGING, AND 1679 01:01:58,314 --> 01:01:59,449 ANIMAL MODELS TAILORED TO 1680 01:01:59,515 --> 01:02:02,752 PEDIATRIC RESEARCH. 1681 01:02:02,819 --> 01:02:07,790 THE FUTURE SHOULD KEEP AN EYE ON 1682 01:02:07,857 --> 01:02:09,926 INCLUSION OF DIVERSIFIED 1683 01:02:09,992 --> 01:02:10,893 PEDIATRIC POPULATIONS INCLUDING 1684 01:02:10,960 --> 01:02:14,030 THOSE WITH CO-INFECTIONS OR WITH 1685 01:02:14,097 --> 01:02:15,698 CHRONIC SUBSTANCE USE OR 1686 01:02:15,765 --> 01:02:16,399 EXPOSURE. 1687 01:02:16,466 --> 01:02:20,403 FINALLY, AN ASPECT THAT WE 1688 01:02:20,470 --> 01:02:22,772 WILL -- IS TO PRIORITIZE AND 1689 01:02:22,839 --> 01:02:23,773 STRATEGIZE THE INCLUSION OF 1690 01:02:23,840 --> 01:02:26,042 PRODUCT DEVELOPMENT FRAMEWORK 1691 01:02:26,109 --> 01:02:29,912 FOR PRE-CLINICAL TO CLINICAL 1692 01:02:29,979 --> 01:02:32,448 TRANSLATION OF PROMISING HIV 1693 01:02:32,515 --> 01:02:33,983 REMISSION STRATEGIES. 1694 01:02:34,050 --> 01:02:36,018 AND WE THINK THAT THIS ACTIVITY 1695 01:02:36,085 --> 01:02:38,321 WILL REQUIRE NOT ONLY INTRINSIC 1696 01:02:38,387 --> 01:02:39,755 INFRASTRUCTURE AND 1697 01:02:39,822 --> 01:02:41,290 COLLABORATIONS, BUT ALSO 1698 01:02:41,357 --> 01:02:42,592 COLLABORATION WITH EXTERNAL 1699 01:02:42,658 --> 01:02:47,430 PARTNERS. 1700 01:02:47,497 --> 01:02:48,731 IN THE AREA OF COMMUNITY 1701 01:02:48,798 --> 01:02:52,201 ENGAGEMENT PROGRAM, KEEP 1702 01:02:52,268 --> 01:02:53,936 EXPANDING THE HEALTH LITERACY, 1703 01:02:54,003 --> 01:02:54,937 KNOWLEDGE DISSEMINATION, WITH 1704 01:02:55,004 --> 01:02:56,572 THE ULTIMATE GOAL TO SHARE THE 1705 01:02:56,639 --> 01:02:57,974 PEDIATRIC HIV CURE AGENDA. 1706 01:02:58,040 --> 01:03:00,643 WE ARE LOOKING TO INCLUDE AND 1707 01:03:00,710 --> 01:03:03,212 EXPAND SOASH R. SOCIOBEHAVIORAL 1708 01:03:03,279 --> 01:03:04,347 ASPECTS IN PARTICULAR TO 1709 01:03:04,413 --> 01:03:05,615 PEDIATRIC HIV CURE RESEARCH, BY 1710 01:03:05,681 --> 01:03:07,150 INCLUDING END USER ACCEPTABILITY 1711 01:03:07,216 --> 01:03:11,387 OF PROMISING HIV CURE 1712 01:03:11,454 --> 01:03:12,121 STRATEGIES, AND LOOKING AT THE 1713 01:03:12,188 --> 01:03:13,289 INTERSECTION OF MENTAL HEALTH 1714 01:03:13,356 --> 01:03:15,925 AND HIV PERSISTENCE. 1715 01:03:15,992 --> 01:03:17,894 AND FINALLY AS PART OF THE 1716 01:03:17,960 --> 01:03:21,497 GLOBAL MDC PROGRAM, THE 1717 01:03:21,564 --> 01:03:23,332 PEDIATRIC EMPHASIS WILL TRAIN 1718 01:03:23,399 --> 01:03:24,700 THE NEXT GENERATION OF PEDIATRIC 1719 01:03:24,767 --> 01:03:26,169 HIV CURE RESEARCHERS AND SHOULD 1720 01:03:26,235 --> 01:03:28,037 BE AN ACTIVE PARTICIPANT OF 1721 01:03:28,104 --> 01:03:30,473 FUTURE CROSS-MDC COLLABORATIONS 1722 01:03:30,540 --> 01:03:31,407 AND COORDINATIONS THROUGH THE 1723 01:03:31,474 --> 01:03:32,975 NEW COORDINATION CENTER. 1724 01:03:33,042 --> 01:03:34,177 AND DIANE IS GOING TO EXPLAIN 1725 01:03:34,243 --> 01:03:35,778 THAT A LITTLE MORE IN THE NEXT 1726 01:03:35,845 --> 01:03:37,880 PRESENTATION. 1727 01:03:37,947 --> 01:03:40,049 SO WE HAD THE PLEASURE TO MEET 1728 01:03:40,116 --> 01:03:42,785 DR. ELAINE ABRAMS AND GRACE 1729 01:03:42,852 --> 01:03:43,519 ALDROVANDI. 1730 01:03:43,586 --> 01:03:45,821 THEY REVIEWED THIS PROPOSAL AND 1731 01:03:45,888 --> 01:03:48,024 AGREED THAT IT SHOULD BE 1732 01:03:48,090 --> 01:03:49,125 APPROVED, AND THEY AGREE THAT 1733 01:03:49,192 --> 01:03:50,760 THE PEDIATRIC MDC WILL BE 1734 01:03:50,826 --> 01:03:52,695 PROVIDING A HOME FOR AND 1735 01:03:52,762 --> 01:03:54,764 FOSTERING INTERDISCIPLINARY 1736 01:03:54,830 --> 01:03:56,532 COLLABORATION THAT SHOULD 1737 01:03:56,599 --> 01:03:57,200 ACCELERATE SCIENTIFIC INQUIRY 1738 01:03:57,266 --> 01:03:58,000 AND ACHIEVEMENTS. 1739 01:03:58,067 --> 01:03:59,702 THEY WANTED US TO CLARIFY THE 1740 01:03:59,769 --> 01:04:01,804 MEANING OF "TRANSLATIONAL 1741 01:04:01,871 --> 01:04:03,873 READINESS" WITHIN THE PEDIATRIC 1742 01:04:03,940 --> 01:04:04,607 MDC. 1743 01:04:04,674 --> 01:04:07,376 WE WORKED THIS OUT IN THE -- AND 1744 01:04:07,443 --> 01:04:09,879 WE DESCRIBED WHAT WILL BE THE 1745 01:04:09,946 --> 01:04:14,217 EXPECTATIONS OF THIS POTENTIAL 1746 01:04:14,283 --> 01:04:16,352 FRAMEWORK FOR DEVELOPMENT, AND 1747 01:04:16,419 --> 01:04:18,621 PROGRAM WILL BE SURE TO WORK ON 1748 01:04:18,688 --> 01:04:21,791 THE FUTURE INITIATIVE TO INCLUDE 1749 01:04:21,857 --> 01:04:23,993 EXPECTATIONS AND REVIEW CRITERIA 1750 01:04:24,060 --> 01:04:26,929 TO ENSURE THAT THERE'S A 1751 01:04:26,996 --> 01:04:28,331 FRAMEWORK FOR POSITIVELY 1752 01:04:28,397 --> 01:04:30,099 ADVANCING PROMISING HIV 1753 01:04:30,166 --> 01:04:31,033 PREVENTION STRATEGIES TO 1754 01:04:31,100 --> 01:04:34,770 CLINICAL TESTING FOR CHILDREN. 1755 01:04:34,837 --> 01:04:36,973 WITH THIS, I FINISH, AND I'M 1756 01:04:37,039 --> 01:04:38,808 HAPPY TO TAKE ANY QUESTIONS OR 1757 01:04:38,874 --> 01:04:39,909 FEEDBACK IF THERE IS TIME. 1758 01:04:39,976 --> 01:04:44,413 THANK YOU. 1759 01:04:44,480 --> 01:04:46,882 >> I'M GOING TO START ONLINE. 1760 01:04:46,949 --> 01:04:56,392 ANY QUESTIONS? 1761 01:04:56,459 --> 01:05:00,896 AND HOW ABOUT ANYBODY HERE? 1762 01:05:00,963 --> 01:05:01,097 OKAY. 1763 01:05:01,163 --> 01:05:09,505 THANK YOU VERY MUCH. 1764 01:05:09,572 --> 01:05:10,940 FOLKS CAN VOTE NOW OR AFTER THE 1765 01:05:11,007 --> 01:05:21,317 NEXT PRESENTATION. 1766 01:05:28,591 --> 01:05:28,991 THANKS AGAIN. 1767 01:05:29,058 --> 01:05:29,525 HELLO. 1768 01:05:29,592 --> 01:05:31,160 THE FINAL CONCEPT THAT WE'LL BE 1769 01:05:31,227 --> 01:05:35,464 PRESENTING TODAY IS THE MARTIN 1770 01:05:35,531 --> 01:05:36,632 DELANEY CLAB TRIS COORDINATION 1771 01:05:36,699 --> 01:05:41,337 CENTER, AND THE PUMPS PURPOSE A 1772 01:05:41,404 --> 01:05:42,505 SIL TATE COMMUNICATION, 1773 01:05:42,571 --> 01:05:43,406 COLLABORATION AND COORDINATION 1774 01:05:43,472 --> 01:05:47,109 AMONG THE INDIVIDUAL MARTIN 1775 01:05:47,176 --> 01:05:48,978 DELANEY COLLABORATORIES AND KEY 1776 01:05:49,045 --> 01:05:49,845 STAKE OLDERS. 1777 01:05:49,912 --> 01:05:52,048 THIS WOULD BE A NEW INITIATIVE 1778 01:05:52,114 --> 01:05:58,354 USING THE U01, AND $.5 MILLION, 1779 01:05:58,421 --> 01:05:59,889 THIS WOULD INCREASE IN YEARS 1780 01:05:59,955 --> 01:06:01,490 2 THROUGH A 5 TO SUPPORT A 1781 01:06:01,557 --> 01:06:02,191 SPECIAL PROGRAM THAT I'LL TALK 1782 01:06:02,258 --> 01:06:03,826 ABOUT FOR NEXT GENERATION 1783 01:06:03,893 --> 01:06:04,126 RESEARCHERS. 1784 01:06:04,193 --> 01:06:05,828 SO WE ANTICIPATE FUNDING ONE 1785 01:06:05,895 --> 01:06:12,234 AWARD. 1786 01:06:12,301 --> 01:06:15,304 SO THE EARLIER PRESENTATIONS -- 1787 01:06:15,371 --> 01:06:16,372 THIS SHOWS THE ORGANIZATION OF 1788 01:06:16,439 --> 01:06:17,707 THE ENTIRE PROGRAM. 1789 01:06:17,773 --> 01:06:19,008 SO IF YOU START AT THE BOTTOM OF 1790 01:06:19,075 --> 01:06:21,844 THE SLIDE, YOU'LL SEE WE HAVE 1791 01:06:21,911 --> 01:06:23,713 OUR TRANS-NIH PROGRAM MANAGEMENT 1792 01:06:23,779 --> 01:06:26,449 TEAM, WHICH INCLUDES NIAID, AND 1793 01:06:26,515 --> 01:06:29,185 OUR PARTNER INSTITUTES. 1794 01:06:29,251 --> 01:06:33,122 FROM NIH. 1795 01:06:33,189 --> 01:06:36,192 AND BASICALLY MONITOR THE 1796 01:06:36,258 --> 01:06:37,259 OVERALL PROGRESS OF EACH 1797 01:06:37,326 --> 01:06:37,793 COLLABORATORY. 1798 01:06:37,860 --> 01:06:40,563 THEN WITHIN DAIDS, THERE ARE 1799 01:06:40,629 --> 01:06:42,531 SEVEN PROGRAM OFFICERS, 1800 01:06:42,598 --> 01:06:45,468 INCLUDING MYSELF AND TANIA, WHO 1801 01:06:45,534 --> 01:06:47,336 ARE FROM THREE DIFFERENT 1802 01:06:47,403 --> 01:06:48,637 BRANCHES THAT OVERSEE THE 1803 01:06:48,704 --> 01:06:49,271 DIFFERENT COLLABORATORY AWARDS. 1804 01:06:49,338 --> 01:06:50,706 THUS WE HAVE ADDITIONAL PROGRAM 1805 01:06:50,773 --> 01:06:51,774 OFFICERS AND PROJECT SCIENTISTS 1806 01:06:51,841 --> 01:06:53,843 THAT ARE INVOLVED INFORMALLY IN 1807 01:06:53,909 --> 01:06:56,412 THE PROGRAMS. 1808 01:06:56,479 --> 01:06:58,948 EACH COLLABORATORY HAS THEIR OWN 1809 01:06:59,014 --> 01:07:00,015 UNIQUE INTERACTIONS WITH PRIVATE 1810 01:07:00,082 --> 01:07:02,151 SECTOR PARTNERS, COMMUNITY 1811 01:07:02,218 --> 01:07:03,252 PARTNERS, CLINICAL RESEARCHES, 1812 01:07:03,319 --> 01:07:06,989 NETWORKS SUCH AS ACTG AND IMPACT 1813 01:07:07,056 --> 01:07:09,392 AS AN EXAMPLE, INTERNATIONAL 1814 01:07:09,458 --> 01:07:10,693 PARTNERS, AND OTHER FUNDERS 1815 01:07:10,760 --> 01:07:12,194 INCLUDING GATES FOUNDATION AND 1816 01:07:12,261 --> 01:07:16,165 AMFAR. 1817 01:07:16,232 --> 01:07:19,468 SO THE RATIONALE FOR 1818 01:07:19,535 --> 01:07:20,870 COORDINATION IS THAT WE FEEL 1819 01:07:20,936 --> 01:07:21,604 FACILITATING COMMUNICATION 1820 01:07:21,670 --> 01:07:23,139 ACROSS THE PROGRAM WILL HELP 1821 01:07:23,205 --> 01:07:25,474 MANAGE THE COMPLEXITY, AND 1822 01:07:25,541 --> 01:07:26,876 PROVIDING OPPORTUNITIES FOR 1823 01:07:26,942 --> 01:07:28,511 SYNERGY WILL ADD VALUE FOR 1824 01:07:28,577 --> 01:07:30,579 OVERCOMING THE COMMON SCIENTIFIC 1825 01:07:30,646 --> 01:07:32,114 CHALLENGES THAT ALL THE 1826 01:07:32,181 --> 01:07:33,416 COLLABORATORIES ARE FACING. 1827 01:07:33,482 --> 01:07:34,550 COMMUNICATION AND COLLABORATION 1828 01:07:34,617 --> 01:07:35,951 AND COORDINATION ACROSS THE 1829 01:07:36,018 --> 01:07:38,220 PROGRAM WILL STRENGTHEN THE 1830 01:07:38,287 --> 01:07:38,788 COLLABORATORY'S COLLECTIVE 1831 01:07:38,854 --> 01:07:40,723 EFFORTS AND HAVING A CENTRALIZED 1832 01:07:40,790 --> 01:07:43,259 INFRASTRUCTURE TO UNIFY THE 1833 01:07:43,325 --> 01:07:45,161 PROGRAM AND ALLOW THE MDCs TO 1834 01:07:45,227 --> 01:07:48,697 MORE EFFICIENTLY WORK TOGETHER 1835 01:07:48,764 --> 01:07:51,333 TO OPTIMIZE CURE STRATEGIES. 1836 01:07:51,400 --> 01:07:55,037 SO THE VISION FOR THE PROGRAM IS 1837 01:07:55,104 --> 01:07:56,839 TO SUPPORT INTEGRATION OF THE 1838 01:07:56,906 --> 01:07:59,542 SCIENCE AND OPERATIONS OF THE 1839 01:07:59,608 --> 01:08:01,043 COLLABORATORIES, WHILE STILL 1840 01:08:01,110 --> 01:08:02,378 ALLOWING THE INDIVIDUAL GROUPS 1841 01:08:02,445 --> 01:08:04,113 TO FOCUS ON THEIR UNIQUE 1842 01:08:04,180 --> 01:08:06,315 SCIENCE. 1843 01:08:06,382 --> 01:08:08,150 SO THE COORDINATION CENTER 1844 01:08:08,217 --> 01:08:09,118 ESSENTIALLY WILL HELP THE GEARS 1845 01:08:09,185 --> 01:08:10,352 TURNING SMOOTHLY SIMILAR TO 1846 01:08:10,419 --> 01:08:12,721 OTHER SUCCESSFUL NIAID-SUPPORTED 1847 01:08:12,788 --> 01:08:14,223 COORDINATION CENTERS, INCLUDING 1848 01:08:14,290 --> 01:08:16,392 HANK FOR THE HIV CLINICAL TRIALS 1849 01:08:16,459 --> 01:08:20,696 NETWORK, AND THE CREEDS 1850 01:08:20,763 --> 01:08:22,031 COORDINATION CENTER FOR EMERGING 1851 01:08:22,097 --> 01:08:24,300 INFECTIOUS DISEASES. 1852 01:08:24,366 --> 01:08:25,835 SO KEY ROLES WILL INCLUDE 1853 01:08:25,901 --> 01:08:26,602 FACILITATING THE EXCHANGE OF 1854 01:08:26,669 --> 01:08:29,438 IDEAS AND BEST PRACTICES, 1855 01:08:29,505 --> 01:08:31,173 COORDINATING CRITICAL ACTIVITIES 1856 01:08:31,240 --> 01:08:31,941 AND ENGAGING EXTERNAL 1857 01:08:32,007 --> 01:08:34,877 STAKEHOLDERS FOR NEEDED 1858 01:08:34,944 --> 01:08:35,578 CONSULTATIONS. 1859 01:08:35,644 --> 01:08:37,213 SIMILAR TO THE FUNCTION OF, FOR 1860 01:08:37,279 --> 01:08:38,581 EXAMPLE, THE UC BERKELEY FORUM 1861 01:08:38,647 --> 01:08:41,884 FOR COLLABORATIVE RESEARCH. 1862 01:08:41,951 --> 01:08:43,219 WHILE COLLABORATORIES GENERALLY 1863 01:08:43,285 --> 01:08:45,521 HAVE BEEN SUPPORTIVE OF EARLY 1864 01:08:45,588 --> 01:08:47,056 STAGE INVESTIGATORS, WE'VE NEVER 1865 01:08:47,122 --> 01:08:48,324 HAD A FORMAL MECHANISM FOR THIS 1866 01:08:48,390 --> 01:08:50,659 IN THE PROGRAM. 1867 01:08:50,726 --> 01:08:52,862 SO IN YEARS 2 THROUGH 5, THE 1868 01:08:52,928 --> 01:08:53,529 COORDINATION CENTER WILL SUPPORT 1869 01:08:53,596 --> 01:08:55,130 A PROGRAM TO CONNECT, SUPPORT 1870 01:08:55,197 --> 01:08:56,499 AND MENTOR A SELECT GROUP OF 1871 01:08:56,565 --> 01:08:57,867 EARLY STAGE INVESTIGATORS FROM 1872 01:08:57,933 --> 01:09:00,169 OUTSIDE THE COLLABORATORY 1873 01:09:00,236 --> 01:09:01,904 NETWORK. ANOTHER IMPORTANT 1874 01:09:01,971 --> 01:09:04,540 FUNCTION WILL BE TO 1875 01:09:04,607 --> 01:09:05,975 COORDINATE -- SHOWN IN THE 1876 01:09:06,041 --> 01:09:07,576 CENTER HERE, TO COORDINATE A 1877 01:09:07,643 --> 01:09:08,811 GROUP OF COMMUNITY AND 1878 01:09:08,878 --> 01:09:09,778 SCIENTIFIC CONSULTANTS WHO WILL 1879 01:09:09,845 --> 01:09:11,080 PROVIDE FEEDBACK ON THE PROGRAM 1880 01:09:11,146 --> 01:09:13,682 AS A WHOLE TO THE 1881 01:09:13,749 --> 01:09:20,589 COLLABORATORIES AND TO NIH. 1882 01:09:20,656 --> 01:09:21,957 SO THE OBJECTIVE OF THE PROGRAM 1883 01:09:22,024 --> 01:09:25,528 IS TO ESTABLISH A COMPREHENSIVE 1884 01:09:25,594 --> 01:09:26,529 CENTRALIZED -- ESTABLISH A 1885 01:09:26,595 --> 01:09:27,162 COMPREHENSIVE COORDINATION 1886 01:09:27,229 --> 01:09:29,231 CENTER THAT SERVES AS A PLATFORM 1887 01:09:29,298 --> 01:09:31,534 FOR A MORE INTEGRATED AND 1888 01:09:31,600 --> 01:09:34,370 STRATEGIC COLLABORATORY RESEARCH 1889 01:09:34,436 --> 01:09:36,338 PROGRAM. 1890 01:09:36,405 --> 01:09:37,640 THE COORDINATION CENTER WOULD 1891 01:09:37,706 --> 01:09:38,841 PROVIDE CENTRALIZED SUPPORT FOR 1892 01:09:38,908 --> 01:09:39,675 ACTIVITIES AND COLLABORATION 1893 01:09:39,742 --> 01:09:40,943 ACROSS THE PROGRAM. 1894 01:09:41,010 --> 01:09:42,578 SERVE AS A NEUTRAL HUB FOR 1895 01:09:42,645 --> 01:09:43,946 EFFECTIVE COMMUNICATION AT 1896 01:09:44,013 --> 01:09:45,347 MULTIPLE LEVELS. 1897 01:09:45,414 --> 01:09:47,216 AND WOULD DEVELOP A 1898 01:09:47,283 --> 01:09:48,851 PUBLIC-FACING WEBSITE THAT WOULD 1899 01:09:48,918 --> 01:09:50,352 PROVIDE CENTRALIZED INFORMATION 1900 01:09:50,419 --> 01:09:52,254 ABOUT THE PROGRAM AND HELP 1901 01:09:52,321 --> 01:09:53,889 ENGAGE EXTERNAL STAKEHOLDERS AND 1902 01:09:53,956 --> 01:10:00,729 NEXT GENERATION RESEARCHERS. 1903 01:10:00,796 --> 01:10:02,064 SO JUST TO SHOW SOME EXAMPLES OF 1904 01:10:02,131 --> 01:10:03,399 OPPORTUNITIES FOR WHAT THE 1905 01:10:03,465 --> 01:10:05,868 COORDINATION CENTER COULD DO, 1906 01:10:05,935 --> 01:10:06,869 CURRENTLY THE COLLABORATORIES 1907 01:10:06,936 --> 01:10:09,071 ARE REQUIRED TO ATTEND ONE JOINT 1908 01:10:09,138 --> 01:10:10,839 SCIENTIFIC MEETING A YEAR, AND 1909 01:10:10,906 --> 01:10:14,176 BASED ON FEEDBACK FROM MULTIPLE 1910 01:10:14,243 --> 01:10:17,246 INVESTIGATORS AND SAB MEMBERS, 1911 01:10:17,313 --> 01:10:18,480 IT SEEMS IT WOULD BE MORE 1912 01:10:18,547 --> 01:10:20,316 HELPFUL TO HAVE MORE FREQUENT 1913 01:10:20,382 --> 01:10:21,650 OPPORTUNITIES FOR INTERACTIONS. 1914 01:10:21,717 --> 01:10:24,820 SO THE COORDINATION CENTER COULD 1915 01:10:24,887 --> 01:10:26,922 ORGANIZE THESE 1916 01:10:26,989 --> 01:10:27,523 CROSS-COLLABORATORY SCIENTIFIC 1917 01:10:27,590 --> 01:10:31,293 MEETINGS AND ALSO ESTABLISH 1918 01:10:31,360 --> 01:10:32,161 TOPICS OF SPECIFIC WORKING 1919 01:10:32,227 --> 01:10:33,896 GROUPS AS THE NEED ARISES. 1920 01:10:33,963 --> 01:10:35,097 FOR EXAMPLE, THE QUESTION THAT 1921 01:10:35,164 --> 01:10:37,199 CAME UP EARLIER ON DIFFERENT 1922 01:10:37,266 --> 01:10:40,235 ANIMAL MODELS AND THERE IS NO 1923 01:10:40,302 --> 01:10:41,470 PERFECT ANIMAL MODEL, BUT 1924 01:10:41,537 --> 01:10:43,072 DIFFERENT ANIMAL MODELS CAN BE 1925 01:10:43,138 --> 01:10:43,973 USEFUL FOR DIFFERENT THINGS AND 1926 01:10:44,039 --> 01:10:47,009 HOW CAN WE COORDINATE THE USE OF 1927 01:10:47,076 --> 01:10:51,780 ANIMAL MODELS TO MOST E 1928 01:10:51,847 --> 01:10:53,282 EFFICIENTLY HEAD TOWARDS A 1929 01:10:53,349 --> 01:10:57,620 CLINICAL SOLUTION. 1930 01:10:57,686 --> 01:10:59,288 ALSO THE COORDINATION CENTER 1931 01:10:59,355 --> 01:11:00,789 COULD FACILITATE CONSULTATIONS 1932 01:11:00,856 --> 01:11:03,025 WITH CLINICAL TRIAL NETWORKS, 1933 01:11:03,092 --> 01:11:04,727 INTERNATIONAL ORGANIZATIONS, 1934 01:11:04,793 --> 01:11:06,495 REGULATORY AGENCIES, INDUSTRY 1935 01:11:06,562 --> 01:11:08,030 AND COMMUNITY, JUST TO GET 1936 01:11:08,097 --> 01:11:08,797 ADDITIONAL PERSPECTIVES THAT 1937 01:11:08,864 --> 01:11:12,301 COULD BENEFIT THE ENTIRE PROG 1938 01:11:12,368 --> 01:11:13,836 PROGRAM. 1939 01:11:13,902 --> 01:11:15,104 THE COORDINATION CENTER ALSO 1940 01:11:15,170 --> 01:11:16,238 COULD PROMOTE EFFECTIVE 1941 01:11:16,305 --> 01:11:19,041 COMMUNICACOMMUNICATION AND ADMIE 1942 01:11:19,108 --> 01:11:19,975 SUPPORT BY COORDINATING 1943 01:11:20,042 --> 01:11:20,909 INFORMATION AND RESEARCH 1944 01:11:20,976 --> 01:11:21,710 EXCHANGE ACROSS THE 1945 01:11:21,777 --> 01:11:23,479 COLLABORATORIES, ESTABLISHING 1946 01:11:23,545 --> 01:11:24,246 HARMONIZED POLICIES AND MAN 1947 01:11:24,313 --> 01:11:28,951 AMOMANAGEMENT PRACTICES, TRACKIG 1948 01:11:29,018 --> 01:11:30,819 AND DISSEMINATING OVERALL 1949 01:11:30,886 --> 01:11:33,188 PROGRESS AND OUTPUTS AND 1950 01:11:33,255 --> 01:11:33,822 ORGANIZING EXTERNAL SCIENTIFIC 1951 01:11:33,889 --> 01:11:34,623 AND COMMUNITY FEEDBACK FOR THE 1952 01:11:34,690 --> 01:11:38,761 ENTIRE PROGRAM. 1953 01:11:38,827 --> 01:11:40,029 THE COORDINATION CENTER WOULD BE 1954 01:11:40,095 --> 01:11:41,296 EXPECTED TO SUPPORT INDIVIDUAL 1955 01:11:41,363 --> 01:11:42,398 COLLABORATORY EFFORTS TO FOSTER 1956 01:11:42,464 --> 01:11:44,233 AND EVALUATE THEIR COMMUNITY 1957 01:11:44,299 --> 01:11:46,435 PARTNERSHIPS AND ACTIVITIES, AND 1958 01:11:46,502 --> 01:11:47,336 TO FACILITATE COMMUNICATION 1959 01:11:47,403 --> 01:11:48,971 ACROSS THE TEAMS TO BROADEN AND 1960 01:11:49,038 --> 01:11:52,341 STRENGTHEN THESE EFFORTS. 1961 01:11:52,408 --> 01:11:53,142 THE COORDINATION CENTER WOULD 1962 01:11:53,208 --> 01:11:54,677 HELP THE COLLABORATORIES PROMOTE 1963 01:11:54,743 --> 01:11:56,512 CONSISTENT USE OF PLAIN LANGUAGE 1964 01:11:56,578 --> 01:11:58,380 RESEARCH SUMMARIES AND ADHERENCE 1965 01:11:58,447 --> 01:12:00,916 TO THE NIAID HIV LANGUAGE GUIDE, 1966 01:12:00,983 --> 01:12:02,785 WHICH AS WE'VE HEARD HAS BEEN 1967 01:12:02,851 --> 01:12:04,520 RECENTLY UPDATED. 1968 01:12:04,586 --> 01:12:07,256 AND IT COULD ALSO HELP THE 1969 01:12:07,322 --> 01:12:07,923 COLLABORATORIES IDENTIFY 1970 01:12:07,990 --> 01:12:11,660 STRATEGIES TO SUPPORT 1971 01:12:11,727 --> 01:12:12,861 SOCIOBEHAVIORAL RESEARCH FOCUSED 1972 01:12:12,928 --> 01:12:16,899 ON ACCEPTABILITY OF POTENTIAL 1973 01:12:16,965 --> 01:12:17,599 CURE INTERVENTIONS. 1974 01:12:17,666 --> 01:12:19,635 AS I MENTIONED, THE COORDINATION 1975 01:12:19,702 --> 01:12:20,836 CENTER WOULD DEVELOP A FORMAL 1976 01:12:20,903 --> 01:12:24,573 PROGRAM TO ENGAGE TALENTED, 1977 01:12:24,640 --> 01:12:25,441 INDEPENDENT EARLY STAGE 1978 01:12:25,507 --> 01:12:27,076 INVESTIGATORS FROM OUTSIDE THE 1979 01:12:27,142 --> 01:12:29,678 CURRENT COLLABORATORY PROGRAM. 1980 01:12:29,745 --> 01:12:31,914 THEY WOULD WORK WITH NIH TO 1981 01:12:31,980 --> 01:12:33,549 DEVELOP THE SOLICITATION, MANAGE 1982 01:12:33,615 --> 01:12:34,616 THE APPLICATION PROCESS AND 1983 01:12:34,683 --> 01:12:35,851 ORGANIZE THE REVIEW. 1984 01:12:35,918 --> 01:12:37,820 SO WE ENVISION THAT AWARDEES 1985 01:12:37,886 --> 01:12:40,322 WOULD RECEIVE UP TO TWO YEARS OF 1986 01:12:40,389 --> 01:12:41,824 FUNDING, AND THIS WOULD BE IN 1987 01:12:41,890 --> 01:12:44,093 TWO COHORTS, SO YEARS TWO TO 1988 01:12:44,159 --> 01:12:45,894 THREE WOULD BE ONE COHORT AND 1989 01:12:45,961 --> 01:12:47,696 THEN IN YEARS FOUR TO FIVE, 1990 01:12:47,763 --> 01:12:48,664 ANOTHER COHORT WOULD BE 1991 01:12:48,731 --> 01:12:49,531 SUPPORTED. 1992 01:12:49,598 --> 01:12:52,568 AND WE'RE LOOKING AT DIFFERENT 1993 01:12:52,634 --> 01:12:54,903 MODELS TO DEVELOP THIS PROGRAM 1994 01:12:54,970 --> 01:13:01,610 AND FOR EXAMPLE, THE CFAR CNIHR 1995 01:13:01,677 --> 01:13:03,078 PROGRAM AS WELL AS THE CENTERS 1996 01:13:03,145 --> 01:13:04,947 FOR HIV STRUCTURAL BIOLOGY 1997 01:13:05,013 --> 01:13:05,814 COLLABORATIVE DEVELOPMENT 1998 01:13:05,881 --> 01:13:08,250 AWARDS, JUST AS SOME GREAT 1999 01:13:08,317 --> 01:13:10,619 EXAMPLES, AND I WOULD NOTE THAT 2000 01:13:10,686 --> 01:13:15,958 ALUMNI OF THE 2013CNIHL PROGRAM 2001 01:13:16,024 --> 01:13:18,260 WITH THE CFARs, THIS WAS A 2002 01:13:18,327 --> 01:13:19,962 CURE-FOCUSED INITIATIVE IN 2013, 2003 01:13:20,028 --> 01:13:22,898 AND ALUMNI FROM THAT PARTICULAR 2004 01:13:22,965 --> 01:13:25,167 COHORT ARE NOW ESTABLISHED CURE 2005 01:13:25,234 --> 01:13:29,905 INVESTIGATORS, INCLUDING 2006 01:13:29,972 --> 01:13:31,440 DR. NDHLOVU, WHO'S ON OUR 2007 01:13:31,507 --> 01:13:31,774 COUNCIL TODAY. 2008 01:13:31,840 --> 01:13:33,041 SO JUST WANTED TO POINT THAT 2009 01:13:33,108 --> 01:13:33,509 OUT. 2010 01:13:33,575 --> 01:13:34,843 ALL RIGHT. 2011 01:13:34,910 --> 01:13:36,512 SO WE FEEL THAT A COORDINATION 2012 01:13:36,578 --> 01:13:38,680 CENTER WOULD BE IMPORTANT TO 2013 01:13:38,747 --> 01:13:39,681 ENHANCE SYNERGY AND 2014 01:13:39,748 --> 01:13:40,215 COLLABORATION ACROSS THE 2015 01:13:40,282 --> 01:13:41,650 COLLABORATORY PROGRAM, 2016 01:13:41,717 --> 01:13:43,385 PARTICULARLY IF THE PROGRAMS ARE 2017 01:13:43,452 --> 01:13:45,420 MORE SPECIALIZED THAN THE 2018 01:13:45,487 --> 01:13:48,524 CURRENT BROADER APPROACHES. 2019 01:13:48,590 --> 01:13:50,726 AND BY SUPPORTING STRATEGIC 2020 01:13:50,793 --> 01:13:52,795 COMMUNICATIONS, LEVERAGING 2021 01:13:52,861 --> 01:13:53,896 COMPLEMENTARY STRENGTHS AND 2022 01:13:53,962 --> 01:13:55,430 FACILITATING TEAM SCIENCE, THE 2023 01:13:55,497 --> 01:13:56,198 COLLABORATORIES CAN WORK 2024 01:13:56,265 --> 01:13:58,367 TOGETHER TO ADVANCE PROMISING 2025 01:13:58,433 --> 01:14:00,302 CLINICAL STRATEGIES FOR HIV 2026 01:14:00,369 --> 01:14:02,504 CURE. 2027 01:14:02,571 --> 01:14:05,040 SO WE ARE VERY THANKFUL FOR THE 2028 01:14:05,107 --> 01:14:06,442 EXCELLENT DISCUSSION FROM ALL OF 2029 01:14:06,508 --> 01:14:09,144 THE REVIEWERS FROM THE PREVIOUS 2030 01:14:09,211 --> 01:14:11,280 TWO PARTS OF THE CONCEPT. 2031 01:14:11,346 --> 01:14:13,448 SO THEY FELT THAT A COORDINATION 2032 01:14:13,515 --> 01:14:20,556 CENTER WOULD BE VALUABLE TO 2033 01:14:20,622 --> 01:14:21,790 INCREASE SYNERGY, REDUCE 2034 01:14:21,857 --> 01:14:22,424 ADMINISTRATIVE BURDEN AND 2035 01:14:22,491 --> 01:14:24,726 PROVIDE A SPACE FOR SHARING AND 2036 01:14:24,793 --> 01:14:25,494 COLLECTIVE SCIENTIFIC PROBLEM 2037 01:14:25,561 --> 01:14:26,595 SOLVING ACROSS THE PROGRAM, AND 2038 01:14:26,662 --> 01:14:29,665 THEY NOTED THAT HANC IS AN 2039 01:14:29,731 --> 01:14:30,833 EXCELLENT EXAMPLE OF THE ABILITY 2040 01:14:30,899 --> 01:14:32,201 TO BUILD WORKING GROUPS AS 2041 01:14:32,267 --> 01:14:33,602 NEEDED AS VALUABLE RESOURCES FOR 2042 01:14:33,669 --> 01:14:36,238 THE PROGRAM. 2043 01:14:36,305 --> 01:14:38,674 THE REVIEWERS FELT THAT ROLES 2044 01:14:38,740 --> 01:14:40,209 AND RESPONSIBILITIES NEEDED TO 2045 01:14:40,275 --> 01:14:42,244 BE CAREFULLY DELINEATED TO MAKE 2046 01:14:42,311 --> 01:14:43,345 SURE THAT THE COORDINATION 2047 01:14:43,412 --> 01:14:45,647 CENTER COULD ADD VALUE AND MEET 2048 01:14:45,714 --> 01:14:47,182 COLLABORATORY NEEDS WITHOUT 2049 01:14:47,249 --> 01:14:48,750 CREATING UNDUE BURDEN THAT WOULD 2050 01:14:48,817 --> 01:14:49,384 SLOW PROGRESS. 2051 01:14:49,451 --> 01:14:51,587 SO WE COMPLETELY AGREE AND WILL 2052 01:14:51,653 --> 01:14:53,222 PLAN TO CAREFULLY DEFINE THESE 2053 01:14:53,288 --> 01:14:56,024 ROLES AND EXPECTATIONS. 2054 01:14:56,091 --> 01:14:57,826 AND I WOULD NOTE THAT BECAUSE OF 2055 01:14:57,893 --> 01:15:00,028 THE COOPERATIVE AGREEMENT 2056 01:15:00,095 --> 01:15:01,263 MECHANISM, DAIDS STAFF WILL BE 2057 01:15:01,330 --> 01:15:02,898 DIRECTLY INVOLVED IN THE 2058 01:15:02,965 --> 01:15:04,466 COORDINATION CENTER AND WILL 2059 01:15:04,533 --> 01:15:05,934 CONTINUOUSLY EVALUATE AND ADJUST 2060 01:15:06,001 --> 01:15:07,669 AS NEEDED. 2061 01:15:07,736 --> 01:15:10,339 THERE WAS A CONCERN OF 2062 01:15:10,405 --> 01:15:14,476 POTENTIALLY CONFLICTING FEEDBACK 2063 01:15:14,543 --> 01:15:18,647 FROM THE CROSS MDC ADVISORS AND 2064 01:15:18,714 --> 01:15:19,448 INDIVIDUAL SCIENTIFIC ADVISORY 2065 01:15:19,514 --> 01:15:20,549 BOARDS, SO WE'VE TRIED TO 2066 01:15:20,616 --> 01:15:22,150 CLARIFY IN THE PRESENTATION THAT 2067 01:15:22,217 --> 01:15:25,988 THE COORDINATING -- COORDINATION 2068 01:15:26,054 --> 01:15:28,190 CENTER SCIENTIFIC CONSULTANTS 2069 01:15:28,257 --> 01:15:29,291 WILL PROVIDE FEEDBACK ON THE 2070 01:15:29,358 --> 01:15:30,726 PROGRAM AS A WHOLE AND WOULD NOT 2071 01:15:30,792 --> 01:15:32,261 SUPERSEDE THE VERY VALUABLE 2072 01:15:32,327 --> 01:15:34,229 FEEDBACK FROM THE INDIVIDUAL 2073 01:15:34,296 --> 01:15:35,097 COLLABORATORY SCIENTIFIC 2074 01:15:35,163 --> 01:15:37,733 ADVISORY BOARDS. 2075 01:15:37,799 --> 01:15:39,568 AND FINALLY, THE REVIEWERS FELT 2076 01:15:39,635 --> 01:15:41,370 THAT A FORMAL PROGRAM TO ENGAGE 2077 01:15:41,436 --> 01:15:42,437 AND SUPPORT EARLY STAGE 2078 01:15:42,504 --> 01:15:44,306 INVESTIGATORS WAS VERY MUCH 2079 01:15:44,373 --> 01:15:45,874 NEEDED, AND THEY WANTED 2080 01:15:45,941 --> 01:15:46,775 ADDITIONAL DETAILS TO CLARIFY 2081 01:15:46,842 --> 01:15:47,809 HOW THE PROGRAM WOULD WORK. 2082 01:15:47,876 --> 01:15:49,444 SO I TRIED TO INCORPORATE THAT 2083 01:15:49,511 --> 01:15:51,980 INTO THE PRESENTATION, AND WOULD 2084 01:15:52,047 --> 01:15:53,215 NOTE THAT DAIDS WILL BE WORKING 2085 01:15:53,282 --> 01:15:54,983 WITH THE COORDINATION CENTER TO 2086 01:15:55,050 --> 01:15:59,755 FINALIZE THE REMAINING DETAILS. 2087 01:15:59,821 --> 01:16:01,523 HAPPY TO TAKE QUESTIONS AND 2088 01:16:01,590 --> 01:16:03,392 TANIA CAN COME UP AS WELL AND 2089 01:16:03,458 --> 01:16:06,762 ANY QUESTIONS ON THE FIRST -- I 2090 01:16:06,828 --> 01:16:08,096 GUESS THE COORDINATION CENTER 2091 01:16:08,163 --> 01:16:10,399 AND THEN ANY REMAINING QUESTIONS 2092 01:16:10,465 --> 01:16:14,670 FROM THE PROGRAM AS A WHOLE. 2093 01:16:14,736 --> 01:16:18,540 >> WE HAVE A QUESTION ONLINE. 2094 01:16:18,607 --> 01:16:18,840 DR. DERDEYN. 2095 01:16:18,907 --> 01:16:20,075 >> HI. 2096 01:16:20,142 --> 01:16:22,711 THIS IS CINDY DERDEYN AGAIN IN 2097 01:16:22,778 --> 01:16:23,145 SEATTLE. 2098 01:16:23,211 --> 01:16:25,013 THIS DOES SOUND LIKE A REALLY 2099 01:16:25,080 --> 01:16:25,447 GREAT IDEA. 2100 01:16:25,514 --> 01:16:29,484 MY QUESTION IS, I GUESS THIS 2101 01:16:29,551 --> 01:16:31,486 WOULD -- THERE WOULD BE A P.I. 2102 01:16:31,553 --> 01:16:35,090 OR SOMEONE, YOU KNOW, AN 2103 01:16:35,157 --> 01:16:35,457 APPLICATION. 2104 01:16:35,524 --> 01:16:36,725 WOULD THAT PERSON HAVE TO BE A 2105 01:16:36,792 --> 01:16:39,461 PERSON WHO DOESN'T HAVE A 2106 01:16:39,528 --> 01:16:41,663 COLLABORATORY OR WOULD YOU BE 2107 01:16:41,730 --> 01:16:43,532 ABLE TO BE P.I. OF A 2108 01:16:43,598 --> 01:16:44,499 COLLABORATORY AND THE 2109 01:16:44,566 --> 01:16:44,967 COORDINATING CENTER? 2110 01:16:45,033 --> 01:16:46,435 I WAS KIND OF UNCLEAR ON HOW 2111 01:16:46,501 --> 01:16:48,403 THAT WOULD WORK. 2112 01:16:48,470 --> 01:16:50,539 >> AT THIS POINT, WE CERTAINLY 2113 01:16:50,605 --> 01:16:54,176 ANTICIPATE THAT THERE WOULD BE 2114 01:16:54,242 --> 01:16:57,512 OPPORTUNITIES FOR PIs WHO ARE 2115 01:16:57,579 --> 01:17:00,649 COLLABORATING OR INVOLVED IN ONE 2116 01:17:00,716 --> 01:17:02,117 OR MORE INDIVIDUAL 2117 01:17:02,184 --> 01:17:03,218 COLLABORATORIES, BUT THE 2118 01:17:03,285 --> 01:17:04,019 COORDINATION CENTER WOULD NEED 2119 01:17:04,086 --> 01:17:08,190 TO BE A NEUTRAL -- A NEUTRAL 2120 01:17:08,256 --> 01:17:10,292 BODY TO MAKE SURE THAT NO ONE 2121 01:17:10,359 --> 01:17:12,027 PARTICULAR COLLABORATORY WAS 2122 01:17:12,094 --> 01:17:15,664 GETTING SPECIAL TREATMENT, FOR 2123 01:17:15,731 --> 01:17:18,100 EXAMPLE, SO AT THIS POINT, I 2124 01:17:18,166 --> 01:17:20,902 WOULD SAY THAT IT WOULD BE 2125 01:17:20,969 --> 01:17:23,538 UNLIKELY THAT WE WOULD ALLOW THE 2126 01:17:23,605 --> 01:17:28,176 SAME PI FOR A COLLABORATORY AND 2127 01:17:28,243 --> 01:17:28,610 COORDINATION CENTER. 2128 01:17:28,677 --> 01:17:29,778 RIGHT NOW WE DON'T ALLOW THE 2129 01:17:29,845 --> 01:17:31,847 SAME PI TO APPLY FOR BOTH THE 2130 01:17:31,913 --> 01:17:33,181 PEDIATRIC AND THE ADULT 2131 01:17:33,248 --> 01:17:35,684 COLLABORATORY. 2132 01:17:35,751 --> 01:17:38,987 SO -- DOES THAT HELP? 2133 01:17:39,054 --> 01:17:41,390 >> YEAH, THAT HELPS A LOT, AND 2134 01:17:41,456 --> 01:17:42,591 IT MAKES SENSE THAT YOU MIGHT 2135 01:17:42,657 --> 01:17:45,994 WANT TO BE A PERSON WHO IS 2136 01:17:46,061 --> 01:17:46,862 SOMEWHAT NEUTRAL. 2137 01:17:46,928 --> 01:17:48,196 SO THAT MAKES A LOT OF SENSE. 2138 01:17:48,263 --> 01:17:52,601 THANK YOU FOR THE CLARIFICATION. 2139 01:17:52,667 --> 01:17:57,039 >> THE PRIMARY ROLE FOR THIS IS 2140 01:17:57,105 --> 01:17:57,939 ADMINISTRATIVE, BUT CLEARLY, 2141 01:17:58,006 --> 01:17:59,374 THERE ALSO WOULD NEED TO BE 2142 01:17:59,441 --> 01:18:01,676 ENOUGH SCIENTIFIC BACKGROUND BY 2143 01:18:01,743 --> 01:18:04,179 COORDINATION CENTER STAFF BUT 2144 01:18:04,246 --> 01:18:10,619 CERTAINLY THERE COULD BE 2145 01:18:10,685 --> 01:18:13,388 OPPORTUNITIES TO BE INVOLVED IN 2146 01:18:13,455 --> 01:18:14,823 MULTIPLE COLLABORATORIES, BUT 2147 01:18:14,890 --> 01:18:16,792 THE P.I. OF THE COORDINATION 2148 01:18:16,858 --> 01:18:18,427 CENTER WOULD HAVE A VERY 2149 01:18:18,493 --> 01:18:23,231 DIFFERENT ROLE THAN THE P.I. OF 2150 01:18:23,298 --> 01:18:26,101 A -- 2151 01:18:26,168 --> 01:18:32,240 >> IT'S GREA TO SEE -- ON MERITS 2152 01:18:32,307 --> 01:18:32,974 OF THE PROGRAM. 2153 01:18:33,041 --> 01:18:34,643 MY QUESTION WAS DIRECTED ON THE 2154 01:18:34,709 --> 01:18:35,243 JUNIOR INVESTIGATORS IN THAT 2155 01:18:35,310 --> 01:18:36,278 PROGRAM. 2156 01:18:36,344 --> 01:18:37,813 YOU MENTIONED THEY WERE LIKELY 2157 01:18:37,879 --> 01:18:39,915 GOING TO BE FROM OUTSIDE OF THE 2158 01:18:39,981 --> 01:18:41,416 COLLABORATORIES OR IS IT OPEN TO 2159 01:18:41,483 --> 01:18:42,217 BOTH? 2160 01:18:42,284 --> 01:18:44,052 AND AS A FOLLOW-UP QUESTION, 2161 01:18:44,119 --> 01:18:50,292 LOOKING BACK AT THE CNIHR 2162 01:18:50,358 --> 01:18:51,426 PROGRAM, WE DID HAVE MENTORS 2163 01:18:51,493 --> 01:18:52,527 ATTACHED TO THAT PROGRAM, I 2164 01:18:52,594 --> 01:18:54,429 WASN'T SURE IF THAT WAS BEING 2165 01:18:54,496 --> 01:18:55,263 DISCUSSED OR ADJUDICATED. 2166 01:18:55,330 --> 01:18:56,898 >> YES, I THINK GENERALLY THE 2167 01:18:56,965 --> 01:19:05,207 IDEA IS TO BRING IN NEW IDEAS, 2168 01:19:05,273 --> 01:19:06,741 NEW MORE JUNIOR INVESTIGATORS 2169 01:19:06,808 --> 01:19:08,043 WHO WE THINK IT WOULD PROBABLY 2170 01:19:08,110 --> 01:19:09,478 WORK BETTER TO HAVE THEM BE 2171 01:19:09,544 --> 01:19:11,012 ALREADY INDEPENDENT SO THAT 2172 01:19:11,079 --> 01:19:13,982 THEY'RE NOT GETTING CONFLICTING 2173 01:19:14,049 --> 01:19:16,384 ADVICE FROM THEIR OWN MENTORS 2174 01:19:16,451 --> 01:19:17,452 VERSUS SOMEONE FROM THE 2175 01:19:17,519 --> 01:19:18,687 COLLABORATORY, BUT YES, I THINK 2176 01:19:18,753 --> 01:19:22,090 THE IDEA WOULD BE TO INCORPORATE 2177 01:19:22,157 --> 01:19:23,625 SOME SORT OF SCIENTIFIC 2178 01:19:23,692 --> 01:19:25,694 COLLABORATION AND MENTORSHIP 2179 01:19:25,760 --> 01:19:27,562 WITH THE COLLABORATORY, SO THE 2180 01:19:27,629 --> 01:19:29,331 IDEA IS TO SORT OF BRING THEM IN 2181 01:19:29,397 --> 01:19:31,900 TO ONE OR MORE COLLABORATORIES, 2182 01:19:31,967 --> 01:19:35,237 AND GET THEM ENGAGED. 2183 01:19:35,303 --> 01:19:36,371 I THINK THERE ARE DIFFERENT 2184 01:19:36,438 --> 01:19:37,772 MODELS THAT WE'RE CONSIDERING SO 2185 01:19:37,839 --> 01:19:39,074 THE SENIOR PROGRAM, FOR EXAMPLE, 2186 01:19:39,141 --> 01:19:41,877 IS A TWO-PHASE PROCESS WHERE THE 2187 01:19:41,943 --> 01:19:43,712 FIRST PHASE IS CONCEPTUAL AND 2188 01:19:43,778 --> 01:19:44,913 THE SECOND PHASE INVOLVES 2189 01:19:44,980 --> 01:19:49,284 WORKING WITH A SPECIFIC CFAR 2190 01:19:49,351 --> 01:19:50,619 INVESTIGATOR TO WRITE THE 2191 01:19:50,685 --> 01:19:51,753 APPLICATION BASICALLY. 2192 01:19:51,820 --> 01:19:54,322 SO THAT'S ONE MODEL, THERE ARE 2193 01:19:54,389 --> 01:19:56,625 OTHER WAYS TO DO IT, SO WE'RE 2194 01:19:56,691 --> 01:19:58,026 DEFINITELY LOOKING AT DIFFERENT 2195 01:19:58,093 --> 01:19:58,426 OPPORTUNITIES. 2196 01:19:58,493 --> 01:20:00,328 BUT THE OVERALL IDEA IS TO BRING 2197 01:20:00,395 --> 01:20:01,696 PEOPLE IN WHO NORMALLY WOULD 2198 01:20:01,763 --> 01:20:04,933 MAYBE NOT HAVE AS MUCH 2199 01:20:05,000 --> 01:20:08,937 CONNECTION WITH THE PROGRAM. 2200 01:20:09,004 --> 01:20:14,943 >> OTHER QUESTIONS? 2201 01:20:15,010 --> 01:20:16,111 >> A GENERAL QUESTION. 2202 01:20:16,178 --> 01:20:18,780 SO YOU HAVE 300 OF THE TOP LABS 2203 01:20:18,847 --> 01:20:22,817 IN THIS NOW WHO ARE GOING TO 2204 01:20:22,884 --> 01:20:24,252 HAVE A COORDINATING CENTER, 2205 01:20:24,319 --> 01:20:25,887 WHICH IS GREAT, AND YOU 2206 01:20:25,954 --> 01:20:26,988 OBVIOUSLY WANT TO HAVE AS MANY 2207 01:20:27,055 --> 01:20:28,523 NEW PEOPLE ENTERING THE FIELD AS 2208 01:20:28,590 --> 01:20:29,658 POSSIBLE, SO I'D LOVE TO HEAR 2209 01:20:29,724 --> 01:20:31,059 WHAT YOUR NEW THOUGHTS ARE IN 2210 01:20:31,126 --> 01:20:35,530 TERMS OF REALLY JUST FINDING 2211 01:20:35,597 --> 01:20:36,531 NON-CONFLICTED QUALIFIED 2212 01:20:36,598 --> 01:20:37,799 REVIEWERS FOR THIS, WHICH I KNOW 2213 01:20:37,866 --> 01:20:40,936 HAS BEEN AN ONGOING CHALLENGE. 2214 01:20:41,002 --> 01:20:42,571 >> FOR THE PROGRAM AS A WHOLE OR 2215 01:20:42,637 --> 01:20:43,905 FOR THE COORDINATION CENTER? 2216 01:20:43,972 --> 01:20:45,440 >> FOR THE PROGRAM AS A WHOLE. 2217 01:20:45,507 --> 01:20:46,074 >> RIGHT. 2218 01:20:46,141 --> 01:20:53,615 YEAH, THAT'S AN EXCELLENT POINT. 2219 01:20:53,682 --> 01:20:54,950 I THINK THEY'RE OUT THERE. 2220 01:20:55,016 --> 01:20:57,586 I THINK WE HAVE TO LOOK AT THE 2221 01:20:57,652 --> 01:21:02,090 FUNCTION OF THE ENTIRE PROGRAM 2222 01:21:02,157 --> 01:21:03,992 AND THAT'S AN EXCELLENT 2223 01:21:04,059 --> 01:21:04,359 CONSIDERATION. 2224 01:21:04,426 --> 01:21:07,462 I KNOW I'M INVOLVED IN A 2225 01:21:07,529 --> 01:21:10,398 DP2 PROGRAM, WHICH IS 2226 01:21:10,465 --> 01:21:11,733 NIAID-WIDE, THERE'S ALSO AN NIH 2227 01:21:11,800 --> 01:21:13,268 VERSION, SO FINDING REVIEWERS TO 2228 01:21:13,335 --> 01:21:17,439 ADDRESS THE BROADER GOALS AND 2229 01:21:17,505 --> 01:21:19,274 CONCEPTS ASSOCIATED WITH THE 2230 01:21:19,341 --> 01:21:22,877 APPLICATIONS IS IMPORTANT, 2231 01:21:22,944 --> 01:21:24,679 AND -- BUT I THINK WE DEFINITELY 2232 01:21:24,746 --> 01:21:27,916 RECOGNIZE THAT THAT'S A CRITICAL 2233 01:21:27,983 --> 01:21:33,622 NEED FOR HAVING A FAIR AND -- A 2234 01:21:33,688 --> 01:21:35,056 FAIR REVIEW WITH APPROPRIATE 2235 01:21:35,123 --> 01:21:39,894 EXPERTISE FOR SURE. 2236 01:21:39,961 --> 01:21:46,268 >> I SEE RAPHI HAS A QUESTION. 2237 01:21:46,334 --> 01:21:49,504 >> JUST AN EXHORTATION AS THE 2238 01:21:49,571 --> 01:21:51,373 U01 COORDINATING CENTER 2239 01:21:51,439 --> 01:21:53,041 SOLICITATION IS CRAFTED, JUST TO 2240 01:21:53,108 --> 01:21:56,778 BE CLEAR ABOUT THE SCOPE OF THE 2241 01:21:56,845 --> 01:21:57,746 COORDINATING CENTER. 2242 01:21:57,812 --> 01:22:01,683 AND I JUST BRING THAT UP KNOWING 2243 01:22:01,750 --> 01:22:04,519 THAT BOTH THE THERAPEUTICS AND 2244 01:22:04,586 --> 01:22:06,054 THE PREVENTION NETWORKS WITH 2245 01:22:06,121 --> 01:22:09,891 WHICH THE MDC'S REPORTS ARE 2246 01:22:09,958 --> 01:22:10,992 COLLABORATING OR PROMISING 2247 01:22:11,059 --> 01:22:12,761 INTERVENTIONS TO GO INTO 2248 01:22:12,827 --> 01:22:15,363 CLINICAL TRIALS APPROPRIATELY 2249 01:22:15,430 --> 01:22:16,498 FIREWALLING LARGELY THOSE TWO 2250 01:22:16,564 --> 01:22:19,467 ACTIVITIES, BULL THE ISSUES OF 2251 01:22:19,534 --> 01:22:22,404 RISKS TO PARTNERS WHEN TREATMENT 2252 01:22:22,470 --> 01:22:23,171 INTERRUPTIONS ARE ASSOCIATED 2253 01:22:23,238 --> 01:22:24,739 WITH SOME OF THESE CURE 2254 01:22:24,806 --> 01:22:26,641 STRATEGIES, WOULD THAT FALL 2255 01:22:26,708 --> 01:22:28,043 WITHIN THE SCOPE OF THIS 2256 01:22:28,109 --> 01:22:29,678 COORDINATING CENTER TO HELP 2257 01:22:29,744 --> 01:22:31,079 THINK ABOUT OR WOULD THAT BE 2258 01:22:31,146 --> 01:22:32,781 RELEGATED TO, FOR EXAMPLE, HANK 2259 01:22:32,847 --> 01:22:33,848 OR ANOTHER GROUP? 2260 01:22:33,915 --> 01:22:34,849 I THINK JUST BEING CLEAR ABOUT 2261 01:22:34,916 --> 01:22:37,285 THAT WOULD BE HELPFUL IN NOT 2262 01:22:37,352 --> 01:22:38,486 HAVING CONFLICTING PARALLEL 2263 01:22:38,553 --> 01:22:44,826 INITIATIVES. 2264 01:22:44,893 --> 01:22:46,795 >> SO I'M NOT SURE -- AS FAR AS 2265 01:22:46,861 --> 01:22:49,164 WOULD THAT SPECIFIC TOPIC BE 2266 01:22:49,230 --> 01:22:50,532 PART OF THE COMMUNITY? 2267 01:22:50,598 --> 01:22:51,966 OR PART OF THE SCIENTIFIC 2268 01:22:52,033 --> 01:22:53,702 OBJECTIVES? 2269 01:22:53,768 --> 01:22:56,037 I WASN'T CLEAR EXACTLY. 2270 01:22:56,104 --> 01:22:59,474 >> I GUESS WHATEVER IS DECIDED 2271 01:22:59,541 --> 01:23:00,408 INTERNALLY, WHETHER OR NOT 2272 01:23:00,475 --> 01:23:02,844 THERE'S OVERLAP WITH HANC OR 2273 01:23:02,911 --> 01:23:03,712 NOT, JUST TO BE CLEAR ABOUT 2274 01:23:03,778 --> 01:23:06,681 WHETHER OR NOT THAT DOMAIN WOULD 2275 01:23:06,748 --> 01:23:08,550 FALL WITHIN THIS SOLICITATION 2276 01:23:08,616 --> 01:23:10,885 AND THE SCOPE OF THIS PROPOSED 2277 01:23:10,952 --> 01:23:11,953 COORDINATING CENTER OR NOT, JUST 2278 01:23:12,020 --> 01:23:13,688 SO PROPOSING GROUPS COULD 2279 01:23:13,755 --> 01:23:16,324 ADDRESS THAT OR NOT 2280 01:23:16,391 --> 01:23:17,759 APPROPRIATELY. 2281 01:23:17,826 --> 01:23:18,460 >> RIGHT. 2282 01:23:18,526 --> 01:23:20,128 WELL, I THINK CERTAINLY -- SO 2283 01:23:20,195 --> 01:23:21,329 ONE ROLE FOR THE COORDINATION 2284 01:23:21,396 --> 01:23:22,731 CENTER WOULD BE TO HELP THE 2285 01:23:22,797 --> 01:23:25,033 INDIVIDUAL COLLABORATORIES 2286 01:23:25,100 --> 01:23:27,202 ADDRESS SPECIFIC ISSUES RELATED 2287 01:23:27,268 --> 01:23:28,636 TO THE TYPES OF STRATEGIES THAT 2288 01:23:28,703 --> 01:23:31,172 THEY'RE DEVELOPING. 2289 01:23:31,239 --> 01:23:32,407 SO -- BUT AS FAR AS OVERLAP, I 2290 01:23:32,474 --> 01:23:38,613 THINK WE CERTAINLY COULD BE 2291 01:23:38,680 --> 01:23:41,082 WORKING WITH HANC, BUT AS FAR AS 2292 01:23:41,149 --> 01:23:44,352 THE OVERLAP, YEAH, I DON'T THINK 2293 01:23:44,419 --> 01:23:46,654 THE -- WE DEFINITELY WOULD BE 2294 01:23:46,721 --> 01:23:52,260 CONSIDERING THE ROLE FOR HANC AS 2295 01:23:52,327 --> 01:23:53,595 A COMPLEMENTARY RESOURCE, SO I 2296 01:23:53,661 --> 01:23:54,929 DON'T THINK WE WOULD BE 2297 01:23:54,996 --> 01:23:55,930 ADDRESSING THAT DIRECTLY. 2298 01:23:55,997 --> 01:24:00,068 >> I THINK BECAUSE OF THE FOCUS 2299 01:24:00,135 --> 01:24:01,302 OF THE COLLABORATORIES, WE 2300 01:24:01,369 --> 01:24:02,604 THOUGHT MOSTLY ABOUT THE 2301 01:24:02,670 --> 01:24:03,471 ACCEPTABILITY OF THE STRATEGIES 2302 01:24:03,538 --> 01:24:05,907 BEING DEVELOPED AND SO FORTH. 2303 01:24:05,974 --> 01:24:08,510 AND THE CLINICAL GROUPS WOULD BE 2304 01:24:08,576 --> 01:24:11,579 MOSTLY FOCUSED AROUND TREATMENT 2305 01:24:11,646 --> 01:24:13,248 INTERRUPTION, BUT TO BRING THOSE 2306 01:24:13,314 --> 01:24:14,115 COMMUNITY GROUPS TOGETHER, TO 2307 01:24:14,182 --> 01:24:15,316 HAVE THAT DIALOGUE TOGETHER AND 2308 01:24:15,383 --> 01:24:16,518 WORK TOGETHER SO THERE'S A 2309 01:24:16,584 --> 01:24:17,719 SEAMLESS HANDOFF FROM ONE TO THE 2310 01:24:17,786 --> 01:24:17,919 OTHER. 2311 01:24:17,986 --> 01:24:19,154 SO I THINK IT'S A GREAT IDEA, 2312 01:24:19,220 --> 01:24:22,457 AND I THINK THAT'S WHERE THE 2313 01:24:22,524 --> 01:24:23,124 COORDINATING CENTER COULD REALLY 2314 01:24:23,191 --> 01:24:23,324 HELP. 2315 01:24:23,391 --> 01:24:24,759 >> RIGHT, BRINGING IN THOSE 2316 01:24:24,826 --> 01:24:26,428 TYPES OF CONSUL TAIGS I THINK 2317 01:24:26,494 --> 01:24:27,195 WOULD BE EXCELLENT. 2318 01:24:27,262 --> 01:24:29,664 >> I CAN JUST ADD THAT ONE OF MY 2319 01:24:29,731 --> 01:24:32,200 GOALS IN SUGGESTING HA NC AS A 2320 01:24:32,267 --> 01:24:34,068 BODY FOR YOU ALL TO WORK WITH 2321 01:24:34,135 --> 01:24:36,571 WAS SO THAT YOU DON'T HAVE TO 2322 01:24:36,638 --> 01:24:38,339 START FROM SCRATCH, BECAUSE HANC 2323 01:24:38,406 --> 01:24:40,241 HAS A LOT OF INFRASTRUCTURE 2324 01:24:40,308 --> 01:24:44,813 ALREADY IN PLACE AND SO IF YOU 2325 01:24:44,879 --> 01:24:47,048 CAN'T USE THE INFRASTRUCTURE, 2326 01:24:47,115 --> 01:24:51,219 MAYBE CULLING IDEAS ABOUT HOW TO 2327 01:24:51,286 --> 01:24:51,853 CREATE THAT INFRASTRUCTURE SO 2328 01:24:51,920 --> 01:24:54,155 YOU CAN KIND OF GET THE BALL 2329 01:24:54,222 --> 01:24:54,889 ROLLING OUT THE GATE. 2330 01:24:54,956 --> 01:24:55,890 >> RIGHT, RIGHT. 2331 01:24:55,957 --> 01:24:59,861 THANK YOU VERY MUCH. 2332 01:24:59,928 --> 01:25:01,696 >> DO YOU JUST WANT TO INTRODUCE 2333 01:25:01,763 --> 01:25:03,298 YOURSELF AS WE FINISH UP? 2334 01:25:03,364 --> 01:25:05,200 >> I'M SORRY. 2335 01:25:05,266 --> 01:25:10,405 I'M LOUIS SHACKELFORD, HE/HIM 2336 01:25:10,472 --> 01:25:12,640 PROGRAMS, THE VACCINE TRIALS 2337 01:25:12,707 --> 01:25:15,510 NETWORK BASED OUT OF FRED 2338 01:25:15,577 --> 01:25:16,878 HUTCHINS, SEATTLE, WASHINGTON. 2339 01:25:16,945 --> 01:25:17,612 >> THANK YOU. 2340 01:25:17,679 --> 01:25:18,880 OKAY. 2341 01:25:18,947 --> 01:25:19,881 I THINK WE'VE ADDRESSED ALL OF 2342 01:25:19,948 --> 01:25:20,615 THE QUESTIONS. 2343 01:25:20,682 --> 01:25:23,618 I WANT TO THANK YOU BOTH FOR THE 2344 01:25:23,685 --> 01:25:24,486 PRESENTATIONS. 2345 01:25:24,552 --> 01:25:26,154 AND ASK ALL THE VOTING MEMBERS 2346 01:25:26,221 --> 01:25:27,822 TO PLACE THEIR VOTES. 2347 01:25:27,889 --> 01:25:38,366 IN THE MEANTIME, I'LL INVITE 2348 01:25:39,100 --> 01:25:40,168 CAROLYN WILLIAMS TO THE PODIUM 2349 01:25:40,235 --> 01:25:50,712 TO TELL US ABOUT THAT IDEA. 2350 01:25:52,547 --> 01:25:53,915 >> IS EVERYONE THROUGH VOTING? 2351 01:25:53,982 --> 01:26:01,022 I DON'T WANT TO -- ALL RIGHT. 2352 01:26:01,089 --> 01:26:03,491 I'M CARLY WILLIAMS, TODAY I'D 2353 01:26:03,558 --> 01:26:04,626 LIKE TO PRESENT TO YOU A LIMITED 2354 01:26:04,692 --> 01:26:06,060 COMPETITION FOR THE 2355 01:26:06,127 --> 01:26:08,997 INTERNATIONAL EPI DATABASES TO 2356 01:26:09,063 --> 01:26:10,331 EVALUATE AIDS PROGRAM, WHICH 2357 01:26:10,398 --> 01:26:13,601 BRINGS TOGETHER EPIDEMIOLOGY 2358 01:26:13,668 --> 01:26:15,003 SCIENCE ACROSS MANY INSTITUTES 2359 01:26:15,069 --> 01:26:17,038 AT THE NIH TO STUDY THE IMPACT 2360 01:26:17,105 --> 01:26:20,141 OF THE HIV EPIDEMIC AND THE 2361 01:26:20,208 --> 01:26:21,543 TREATMENT OF HIV GLOBALLY. 2362 01:26:21,609 --> 01:26:22,677 IT'S A LIMITED COMPETITION. 2363 01:26:22,744 --> 01:26:25,313 IT WILL BE A U01 AS IT HAS BEEN 2364 01:26:25,380 --> 01:26:26,948 BEFORE, A COOPERATIVE AGREEMENT. 2365 01:26:27,015 --> 01:26:29,350 THIS IS A REISSUE FOR FIVE YEARS 2366 01:26:29,417 --> 01:26:32,220 WITH NIAID'S CONTRIBUTION AT 2367 01:26:32,287 --> 01:26:32,554 $9.2 MILLION. 2368 01:26:32,620 --> 01:26:34,088 AS YOU CAN SEE, WE'VE HAD MANY 2369 01:26:34,155 --> 01:26:35,356 INSTITUTES THAT HAVE CO-FUNDED 2370 01:26:35,423 --> 01:26:37,191 WITH US IN THE PAST, AND HAVE 2371 01:26:37,258 --> 01:26:38,626 EXPRESSED AN INTEREST TO 2372 01:26:38,693 --> 01:26:40,295 CONTINUE WITH US AS WELL AS 2373 01:26:40,361 --> 01:26:41,963 MAYBE BRINGING IN SOME OTHER 2374 01:26:42,030 --> 01:26:49,070 INSTITUTES. 2375 01:26:49,137 --> 01:26:52,507 SO THIS INCLUDES 44 COUNTRIES 2376 01:26:52,574 --> 01:26:53,041 AND 388 CLINICAL SITES. 2377 01:26:53,107 --> 01:26:54,175 WE HAVE MORE THAN 2 MILLION 2378 01:26:54,242 --> 01:26:57,745 PEOPLE LIVING WITH HIV WHO HAVE 2379 01:26:57,812 --> 01:26:58,980 CONTRIBUTED DATA TO THE DATABASE 2380 01:26:59,047 --> 01:27:01,182 WITH ABOUT 200,000 CHILDREN BOTH 2381 01:27:01,249 --> 01:27:04,552 WITH HIV AND EXPOSED TO HIV 2382 01:27:04,619 --> 01:27:06,321 DURING PREGNANCY. 2383 01:27:06,387 --> 01:27:07,088 THE PROGRAM SUPPORTS THE 2384 01:27:07,155 --> 01:27:09,924 COLLECTION OF DATA AT THE 2385 01:27:09,991 --> 01:27:10,825 CLINICAL LEVEL FROM CLINICS THAT 2386 01:27:10,892 --> 01:27:12,627 RANGE FROM SMALL RURAL 2387 01:27:12,694 --> 01:27:14,262 FACILITIES TO LARGE TERTIARY 2388 01:27:14,329 --> 01:27:16,297 CARE HOSPITALS ACROSS THESE 2389 01:27:16,364 --> 01:27:16,965 REGIONS. 2390 01:27:17,031 --> 01:27:20,101 AND THEY CONDUCT RESEARCH AT THE 2391 01:27:20,168 --> 01:27:22,270 CLINIC LEVEL AND AT THE REGIONAL 2392 01:27:22,337 --> 01:27:25,206 LEVEL, AS WELL AS ACROSS THE 2393 01:27:25,273 --> 01:27:27,342 COUNTRY, THE PROJECT INVOLVES 2394 01:27:27,408 --> 01:27:28,543 BRINGING ALONG RESEARCHERS 2395 01:27:28,610 --> 01:27:30,411 WITHIN THE PROGRAM, INVITING OUT 2396 01:27:30,478 --> 01:27:32,647 TO OTHER INVESTIGATORS, AND IT 2397 01:27:32,714 --> 01:27:33,748 CAN SERVE AS A PLATFORM FOR 2398 01:27:33,815 --> 01:27:38,753 OTHER RESEARCH PROJECTS. 2399 01:27:38,820 --> 01:27:41,789 SO IEDEA IS VERY MUCH A DATA 2400 01:27:41,856 --> 01:27:42,323 SCIENCE PROGRAM. 2401 01:27:42,390 --> 01:27:45,159 IT SITS NEXT TO AN R24 GRANT 2402 01:27:45,226 --> 01:27:50,999 CALLED HA HARMONIST WITH A SUITF 2403 01:27:51,065 --> 01:27:52,367 SOFTWARE THAT REALLY HELPS US 2404 01:27:52,433 --> 01:27:54,502 DAYS TAKE DATA FROM THE CLINIC, 2405 01:27:54,569 --> 01:27:56,771 WHICH THEN GOES TO A REGIONAL 2406 01:27:56,838 --> 01:27:59,273 DATASET, IT GOES THROUGH A SET 2407 01:27:59,340 --> 01:28:02,477 OF SOFTWARE PROGRAMS TO 2408 01:28:02,543 --> 01:28:06,648 STANDARDIZE IT, BRINGING IT INTO 2409 01:28:06,714 --> 01:28:08,916 THE IEDEA DATA STANDARD, 2410 01:28:08,983 --> 01:28:09,984 EVALUATE THE QUALITY OF THAT 2411 01:28:10,051 --> 01:28:11,219 DATA AND THEN BRING THAT BACK TO 2412 01:28:11,285 --> 01:28:11,919 THE CLINIC TO IMPROVE THE 2413 01:28:11,986 --> 01:28:13,855 QUALITY OF DATA, ENGAGE WITH THE 2414 01:28:13,921 --> 01:28:16,090 INVESTIGATORS IN THE FIELD, WHY 2415 01:28:16,157 --> 01:28:16,991 DOES THE DATA LOOK LIKE THIS, 2416 01:28:17,058 --> 01:28:18,359 WHY IS THIS MISSING, WHY IS 2417 01:28:18,426 --> 01:28:20,261 THAT -- TO CREATE DATASETS THAT 2418 01:28:20,328 --> 01:28:23,264 ARE ACCURATE REPRESENTATIONS OF 2419 01:28:23,331 --> 01:28:24,799 WHAT IS IN THE CLINIC DATASET, 2420 01:28:24,866 --> 01:28:27,435 WHICH CAN THEN BE USED FOR A 2421 01:28:27,502 --> 01:28:28,269 SPECIFIC ANALYSIS. 2422 01:28:28,336 --> 01:28:30,038 SOMETIMES THEY'RE USED FOR 2423 01:28:30,104 --> 01:28:31,005 GLOBAL DATASETS. 2424 01:28:31,072 --> 01:28:34,742 WE HAVE NOW A MULTIUSE DATASET 2425 01:28:34,809 --> 01:28:36,244 THAT IS A MORE STATIC DATASET 2426 01:28:36,310 --> 01:28:37,645 THAT'S A LITTLE BIT FASTER FOR 2427 01:28:37,712 --> 01:28:43,117 PEOPLE TO ACCESS, AND THEN MOVE 2428 01:28:43,184 --> 01:28:47,288 INTO ANALYSES. 2429 01:28:47,355 --> 01:28:48,556 OF COURSE A CONSORTIUM THIS BIG 2430 01:28:48,623 --> 01:28:53,461 IS REALLY ALL ABOUT NETWORKING. 2431 01:28:53,528 --> 01:28:54,662 AND ABOUT HOW WE BRING PEOPLE 2432 01:28:54,729 --> 01:28:55,229 TOGETHER. 2433 01:28:55,296 --> 01:28:55,963 WHEN WE STARTED THIS PROGRAM, 2434 01:28:56,030 --> 01:28:57,031 ONE OF THE ELEMENTS WE TRIED TO 2435 01:28:57,098 --> 01:28:58,666 PUSH OUT WAS A CONCEPT OF 2436 01:28:58,733 --> 01:28:59,600 CULTURES OF TRUST IN WHICH 2437 01:28:59,667 --> 01:29:01,235 PEOPLE ARE WORKING WITH EACH 2438 01:29:01,302 --> 01:29:03,104 OTHER WITH A VERY WELL-DEFINED 2439 01:29:03,171 --> 01:29:05,773 SET OF RESEARCH PROCEDURES, 2440 01:29:05,840 --> 01:29:07,809 MANAGEMENT OF DATA, AND 2441 01:29:07,875 --> 01:29:10,244 ADHERENCE TO THE CONCEPT OF THE 2442 01:29:10,311 --> 01:29:11,579 NETWORK. 2443 01:29:11,646 --> 01:29:13,247 SO THE ANALYSES CAN BE CONDUCTED 2444 01:29:13,314 --> 01:29:15,917 WITHIN THE COHORT, MAYBE THEY 2445 01:29:15,983 --> 01:29:22,590 ARE A BI- OR TRI-REGIONAL 2446 01:29:22,657 --> 01:29:25,693 PROJECT WORKING TOGETHER, THE 2447 01:29:25,760 --> 01:29:28,496 COHORT STUDY DATA ON ADOLESCENTS 2448 01:29:28,563 --> 01:29:30,164 AND YOUNG ADULTS. 2449 01:29:30,231 --> 01:29:33,301 THE SENTINEL RESEARCH, PERSONS 2450 01:29:33,367 --> 01:29:35,803 OVER 40 YEARS OLD, OR THE TBSRN, 2451 01:29:35,870 --> 01:29:37,739 WHICH IS SPECIFIC DATA THAT ARE 2452 01:29:37,805 --> 01:29:39,507 COLLECTED TO ADDRESS SOME GAPS 2453 01:29:39,574 --> 01:29:41,409 IN DATA THAT WE'VE IDENTIFIED 2454 01:29:41,476 --> 01:29:49,917 OVER THE COURSE OF IEDEA. 2455 01:29:49,984 --> 01:29:52,120 THE REGIONS ALL COLLABORATE 2456 01:29:52,186 --> 01:29:53,755 TOGETHER TO DO THE WORK OF 2457 01:29:53,821 --> 01:29:55,823 RUNNING A CONSORTIUM LIKE THIS, 2458 01:29:55,890 --> 01:29:56,991 SO ONE REGION MAY BE HANDLING 2459 01:29:57,058 --> 01:30:00,495 THE MEETINGS, ONE REGION MAY BE 2460 01:30:00,561 --> 01:30:04,132 WORKING WITH THE CALLS IN 2461 01:30:04,198 --> 01:30:05,500 BETWEEN, SO THE WORK IS 2462 01:30:05,566 --> 01:30:07,568 DISTRIBUTED OUT ACROSS THE 2463 01:30:07,635 --> 01:30:08,102 REGION. 2464 01:30:08,169 --> 01:30:10,738 AS I MENTIONED, THERE'S ALSO 2465 01:30:10,805 --> 01:30:12,406 COLLABORATIONS OUTSIDE OF THE 2466 01:30:12,473 --> 01:30:16,911 CONSORTIUM WITH, SAY, THE WHO, 2467 01:30:16,978 --> 01:30:19,180 UND AIDS OR PEPFAR ENTITIES. 2468 01:30:19,247 --> 01:30:20,882 THE CONSORTIUM IS VERY WELL 2469 01:30:20,948 --> 01:30:22,450 ESTABLISHED NOW AND HAS A PRETTY 2470 01:30:22,517 --> 01:30:26,687 STANDARD RATE OF PRODUCTION OF 2471 01:30:26,754 --> 01:30:28,422 PAPERS, IN EACH CYCLE THEY'VE 2472 01:30:28,489 --> 01:30:29,257 PRODUCED OVER A THOUSAND PAPERS 2473 01:30:29,323 --> 01:30:30,458 IN THE LAST TWO ROUNDS OF 2474 01:30:30,525 --> 01:30:33,194 INVESTIGATIONS, AND YOU CAN SEE 2475 01:30:33,261 --> 01:30:35,429 MANY ARE AT THE REGIONAL LEVEL, 2476 01:30:35,496 --> 01:30:37,632 WITH A FEW THAT ARE 2477 01:30:37,698 --> 01:30:42,637 MULTIREGIONAL PAPERS. 2478 01:30:42,703 --> 01:30:44,839 TO DESCRIBE THE BREADTH OF 2479 01:30:44,906 --> 01:30:47,441 RESEARCH IN IEDEA IS QUITE 2480 01:30:47,508 --> 01:30:48,776 DIFFICULT AND I ENCOURAGE PEOPLE 2481 01:30:48,843 --> 01:30:50,745 WHO ARE INTERESTED TO GO TO THE 2482 01:30:50,812 --> 01:30:53,080 WEBSITE AT IEDEA.ORG AND YOU CAN 2483 01:30:53,147 --> 01:30:54,515 SEE THE FULL LIST OF 2484 01:30:54,582 --> 01:30:55,149 PUBLICATIONS FROM THE GROUP. 2485 01:30:55,216 --> 01:30:56,517 BUT THERE HAVE BEEN BIG PAPERS 2486 01:30:56,584 --> 01:30:59,287 THAT HAVE COME OUT OVER THE LAST 2487 01:30:59,353 --> 01:31:01,022 MANY YEARS. 2488 01:31:01,088 --> 01:31:02,423 THE WHEN TO START PAPERS FROM 2489 01:31:02,490 --> 01:31:04,992 THE CONSORTIUM AROUND 2007, I 2490 01:31:05,059 --> 01:31:06,427 BELIEVE THAT PAPER WAS 2491 01:31:06,494 --> 01:31:09,063 PUBLISHED, LOOKING AT LOST TO 2492 01:31:09,130 --> 01:31:10,264 FOLLOW-UP, SOME RESEARCH ON 2493 01:31:10,331 --> 01:31:11,999 CANCER AND CARDIOVASCULAR 2494 01:31:12,066 --> 01:31:13,534 OUTCOMES, EACH OF WHICH 2495 01:31:13,601 --> 01:31:14,502 CONTRIBUTE AT THE REGIONAL AND 2496 01:31:14,569 --> 01:31:18,005 GLOBAL LEVEL. 2497 01:31:18,072 --> 01:31:19,340 BECAUSE WE SIT WITHIN REGIONS 2498 01:31:19,407 --> 01:31:20,474 AND SUPPORT THE INVESTIGATORS 2499 01:31:20,541 --> 01:31:22,210 WITHIN THOSE REGIONS, IT'S A 2500 01:31:22,276 --> 01:31:24,345 FANTASTIC PLACE TO GET YOUR 2501 01:31:24,412 --> 01:31:24,712 ADVANCED DEGREE. 2502 01:31:24,779 --> 01:31:26,414 WE'VE HAD A LOT OF INVESTIGATORS 2503 01:31:26,480 --> 01:31:28,416 WHO'VE MOVED THROUGH THE RAM IN 2504 01:31:28,482 --> 01:31:30,384 EACH OF THE REGIONS, AND 2505 01:31:30,451 --> 01:31:33,654 ACHIEVING UPPER LEVEL DESCREES, 2506 01:31:33,721 --> 01:31:36,290 WHETHER THEY'RE MASTER'S, 2507 01:31:36,357 --> 01:31:39,961 DOCTORAL, EARLY STAGE OR -- 2508 01:31:40,027 --> 01:31:40,962 ACHIEVEMENTS. 2509 01:31:41,028 --> 01:31:47,468 THE P.I. RECEIVED HER PH.D. US 2510 01:31:47,535 --> 01:31:50,504 USING IEDEA DATA. 2511 01:31:50,571 --> 01:31:53,040 THIS WINTER, THERE WAS DATA ON 2512 01:31:53,107 --> 01:31:55,209 DOLUTEGRAVIR SO I WANTED TO TALK 2513 01:31:55,276 --> 01:31:58,045 ABOUT THE THINGS IEDEA DOES IN 2514 01:31:58,112 --> 01:31:59,447 THE AREA WHICH I THINK IS REALLY 2515 01:31:59,513 --> 01:32:00,248 INTERESTING WHICH IS MODELING 2516 01:32:00,314 --> 01:32:01,482 AND USING THIS BIG DATA 2517 01:32:01,549 --> 01:32:02,884 STRUCTURE TO ANSWER SOME 2518 01:32:02,950 --> 01:32:03,451 FUNDAMENTAL QUESTIONS. 2519 01:32:03,517 --> 01:32:04,752 ONE OF THE BIGGEST QUESTIONS FOR 2520 01:32:04,819 --> 01:32:05,753 COUNTRIES IS FORECASTING THEIR 2521 01:32:05,820 --> 01:32:07,989 NEEDS AND UNDERSTANDING THE 2522 01:32:08,055 --> 01:32:08,990 POPULATIONS OF PEOPLE WHO ARE 2523 01:32:09,056 --> 01:32:11,058 INFECTED WITH HIV WITHIN THE 2524 01:32:11,125 --> 01:32:12,860 COMMUNITY, AND A QUESTION AROSE 2525 01:32:12,927 --> 01:32:14,095 ABOUT HOW MANY CHILDREN ARE 2526 01:32:14,161 --> 01:32:16,731 THERE WHO ARE HIV INFECTED. 2527 01:32:16,797 --> 01:32:18,099 SO WORKING WITH THE SPECTRUM 2528 01:32:18,165 --> 01:32:21,669 TEAM ON THEIR PEDIATRIC SPECTRUM 2529 01:32:21,736 --> 01:32:24,071 MODEL, IEDEA CONTRIBUTED NEW 2530 01:32:24,138 --> 01:32:25,206 PARAMETERS FOR THAT MODEL, AND 2531 01:32:25,273 --> 01:32:26,574 IT SHOWED A NUMBER OF THINGS. 2532 01:32:26,641 --> 01:32:28,409 ONE WAS, FEWER CHILDREN WERE 2533 01:32:28,476 --> 01:32:31,779 ACTUALLY GETTING INFECTED 2534 01:32:31,846 --> 01:32:32,079 PERINATALLY. 2535 01:32:32,146 --> 01:32:33,381 SO THERE WAS A LOWER NUMBER OF 2536 01:32:33,447 --> 01:32:35,983 CHILDREN WHO WERE INITIALLY 2537 01:32:36,050 --> 01:32:37,285 INFECTED, BUT UNFORTUNATELY 2538 01:32:37,351 --> 01:32:38,619 AMONG THOSE CHILDREN WHO WERE 2539 01:32:38,686 --> 01:32:39,587 INFECTED, THEY WERE STARTING 2540 01:32:39,654 --> 01:32:41,622 CARE LATER THAN HAD BEEN 2541 01:32:41,689 --> 01:32:43,157 ANTICIPATED, SO MORTALITY RATES 2542 01:32:43,224 --> 01:32:44,725 WHY ACTUALLY HIGHER IN THOSE 2543 01:32:44,792 --> 01:32:45,793 CHILDREN THAN WE HAD 2544 01:32:45,860 --> 01:32:46,661 ANTICIPATED. 2545 01:32:46,727 --> 01:32:50,331 AND THOSE TWO ELEMENTS COMBINED 2546 01:32:50,398 --> 01:32:51,098 TOGETHER MEAN THAT THERE ARE 2547 01:32:51,165 --> 01:32:53,601 MANY FEWER CHILDREN LIVING WITH 2548 01:32:53,668 --> 01:32:55,169 HIV TODAY. 2549 01:32:55,236 --> 01:32:56,737 27% LOWER, A THIRD LOWER. 2550 01:32:56,804 --> 01:32:58,572 SO A BIG SHIFT IN OUR 2551 01:32:58,639 --> 01:32:59,674 UNDERSTANDING ABOUT WHERE THE 2552 01:32:59,740 --> 01:33:01,475 EPIDEMIC IS AND HOW TO 2553 01:33:01,542 --> 01:33:05,479 ANTICIPATE AND FORECAST NEEDS. 2554 01:33:05,546 --> 01:33:07,515 ANOTHER AREA WHERE IT'S BEEN 2555 01:33:07,581 --> 01:33:08,382 ABLE TO CONTRIBUTE IS LOOKING AT 2556 01:33:08,449 --> 01:33:14,522 THE U.S. AND LOOKING AT THE HIV 2557 01:33:14,588 --> 01:33:15,022 EPIDEMIC. 2558 01:33:15,089 --> 01:33:17,391 IN THE TOP GRAPH HERE WE SEE 2559 01:33:17,458 --> 01:33:19,527 THREE TIMES 2010, 2020 AND 2030. 2560 01:33:19,593 --> 01:33:21,629 THIS IS THE PROPORTION OF ALL 2561 01:33:21,696 --> 01:33:23,597 PEOPLE WHO HAVE HIV. 2562 01:33:23,664 --> 01:33:28,970 SO IN 2010, WE SEE THAT WE HAVE 2563 01:33:29,036 --> 01:33:31,505 THIS PRETTY SIMPLE CURVE HERE, 2564 01:33:31,572 --> 01:33:32,073 NORMAL DISTRIBUTION OF HIV 2565 01:33:32,139 --> 01:33:32,640 INFECTION. 2566 01:33:32,707 --> 01:33:33,841 THE MEDIAN AGE OF PEOPLE WHO 2567 01:33:33,908 --> 01:33:37,511 HAVE HIV IS ABOUT 46 YEARS IN 2568 01:33:37,578 --> 01:33:38,946 THE UNITED STATES. 2569 01:33:39,013 --> 01:33:40,581 AND OVER TIME, THESE CURVES SEEM 2570 01:33:40,648 --> 01:33:42,650 TO BE SHIFTING OVER TO OLDER AGE 2571 01:33:42,717 --> 01:33:44,719 GROUPS, WHICH MAKES SENSE AS WE 2572 01:33:44,785 --> 01:33:45,820 HAVE THERAPY. 2573 01:33:45,886 --> 01:33:47,221 UNFORTUNATELY, THOUGH, WE ALSO 2574 01:33:47,288 --> 01:33:49,323 HAVE A NEW GROUP OF PEOPLE WHO 2575 01:33:49,390 --> 01:33:54,628 ARE INFECTED WHO BECOME A PARENT 2576 01:33:54,695 --> 01:33:56,030 IN 2020 AND REMAIN IN 2030. 2577 01:33:56,097 --> 01:33:58,065 THESE ARE NEW YOUNG INFECTIONS 2578 01:33:58,132 --> 01:33:59,834 ANTICIPATED TO OCCUR. 2579 01:33:59,900 --> 01:34:04,338 IF THERE IS NO PROGRESS ON THE 2580 01:34:04,405 --> 01:34:04,672 INITIATIVE. 2581 01:34:04,739 --> 01:34:08,342 BUT IF WE ARE SUCCESSFUL WITH 2582 01:34:08,409 --> 01:34:11,045 THE MB HIV EPIDEMIC, WE SEE THE 2583 01:34:11,112 --> 01:34:12,013 CURVE MOVES OVER TOWARD THE 2584 01:34:12,079 --> 01:34:13,781 RIGHT WITH PEOPLE AGING, BUT 2585 01:34:13,848 --> 01:34:16,884 WITHOUT, THIS GROUP HERE, THIS 2586 01:34:16,951 --> 01:34:18,886 LARGER GROUP OF YOUNG PEOPLE 2587 01:34:18,953 --> 01:34:19,653 GETTING INFECTED. 2588 01:34:19,720 --> 01:34:22,189 SO YOU CAN SEE THAT THIS BUMP IS 2589 01:34:22,256 --> 01:34:24,859 WIDER AND BIGGER THAN THIS BUMP, 2590 01:34:24,925 --> 01:34:28,329 WHICH IS NOW LEAVING WITH MORE 2591 01:34:28,396 --> 01:34:31,065 YOUNG PEOPLE NOT INFECTED. 2592 01:34:31,132 --> 01:34:33,801 SO A HOPEFUL LOOK FOR THE 2013. 2593 01:34:33,868 --> 01:34:36,303 WE SEE HERE WITHOUT THE SUCCESS 2594 01:34:36,370 --> 01:34:40,941 OF THE PROGRAM, 54,000 PEOPLE 2595 01:34:41,008 --> 01:34:43,144 UNDER 30 INFECTED WITH HIV, 2596 01:34:43,210 --> 01:34:45,012 WHEREAS WITH SUCCESS IN THE 2597 01:34:45,079 --> 01:34:45,780 PROGRAM, ONLY 16,000. 2598 01:34:45,846 --> 01:34:48,482 SO THESE ARE THE KIND OF 2599 01:34:48,549 --> 01:34:49,984 SUBSTANTIVE PROGRESS THAT WE 2600 01:34:50,051 --> 01:34:52,953 SHOULD HOPE TO BE ABLE TO SEE IF 2601 01:34:53,020 --> 01:34:54,021 IT'S SUCCESSFUL, BUT THEN WE 2602 01:34:54,088 --> 01:34:56,057 ALSO HAVE TO NOTE THAT THE 2603 01:34:56,123 --> 01:34:57,725 PREVALENCE OF THE EPIDEMIC, THE 2604 01:34:57,792 --> 01:35:00,327 NUMBER OF PEOPLE WHO REMAIN 2605 01:35:00,394 --> 01:35:01,695 HIV-INFECTED WILL CONTINUE, AND 2606 01:35:01,762 --> 01:35:03,898 WE WILL CONTINUE TO HAVE A 2607 01:35:03,964 --> 01:35:06,700 NUMBER OF PEOPLE WITH LONG-TERM 2608 01:35:06,767 --> 01:35:07,301 COMORBIDITIES ASSOCIATED WITH 2609 01:35:07,368 --> 01:35:08,769 THEIR HIV INFECTION. 2610 01:35:08,836 --> 01:35:10,204 BECAUSE THIS IS A LARGE PROGRAM 2611 01:35:10,271 --> 01:35:11,572 AND WE'RE RECOMPETING IT AGAIN 2612 01:35:11,639 --> 01:35:13,607 FOR THE FIFTH TIME, WE ASKED FOR 2613 01:35:13,674 --> 01:35:16,744 AN EXTERNAL EVALUATION OF THE 2614 01:35:16,811 --> 01:35:18,746 PROGRAM WHICH WAS CONDUCTED BY A 2615 01:35:18,813 --> 01:35:19,647 CONTRACTING GROUP. 2616 01:35:19,713 --> 01:35:20,948 AND THEY INTERVIEWED OTHER 2617 01:35:21,015 --> 01:35:22,817 PROGRAM OFFICERS ACROSS THE NIH 2618 01:35:22,883 --> 01:35:24,552 ABOUT THEIR INTERACTION WITH THE 2619 01:35:24,618 --> 01:35:26,520 PROGRAM AS WELL AS MEMBERS OF 2620 01:35:26,587 --> 01:35:29,990 THE WHO TEAM, WHO USE THE DATA. 2621 01:35:30,057 --> 01:35:31,425 AND THE RESULTS OF THIS 2622 01:35:31,492 --> 01:35:35,863 EVALUATION WERE QUITE FAVORABLE. 2623 01:35:35,930 --> 01:35:37,832 IEDEA IS SEEN AS A HIGHLY 2624 01:35:37,898 --> 01:35:39,133 SUCCESSFUL PROGRAM THAT IS 2625 01:35:39,200 --> 01:35:41,068 CRITICAL FOR GLOBAL HEALTH. 2626 01:35:41,135 --> 01:35:42,403 THIS CONFLICT THAT WE HAVE 2627 01:35:42,470 --> 01:35:44,171 BETWEEN BEING A LARGE COHORT 2628 01:35:44,238 --> 01:35:46,907 STUDY THAT FOLLOWS MILLIONS OF 2629 01:35:46,974 --> 01:35:49,710 PATIENTS VERSUS HAVING THESE 2630 01:35:49,777 --> 01:35:54,515 SUBCOHORTS OF THE SENTINEL 2631 01:35:54,582 --> 01:35:57,251 RESEARCH NETWORK, THE SMALL 2632 01:35:57,318 --> 01:35:59,920 COHORTS SEEM TO BE PLAYING A 2633 01:35:59,987 --> 01:36:02,223 ROLE, THE TRAINING HAS BEEN 2634 01:36:02,289 --> 01:36:04,391 IMPACTFUL, THERE WAS A BIG 2635 01:36:04,458 --> 01:36:05,493 CONFLICT BETWEEN OUR HOPE TO 2636 01:36:05,559 --> 01:36:07,661 EXPAND AND TO INCLUDE ADDITIONAL 2637 01:36:07,728 --> 01:36:10,030 QUESTIONS BUT YET WANTING TO 2638 01:36:10,097 --> 01:36:12,032 MAINTAIN OUR FOCUS, THE OPINION 2639 01:36:12,099 --> 01:36:13,434 OF REVIEWERS IS QUITE MIXED ON 2640 01:36:13,501 --> 01:36:16,036 THE ADDITION OF CLINICAL TRIALS 2641 01:36:16,103 --> 01:36:17,404 TO THE PROJECT AND YOU'LL NOTICE 2642 01:36:17,471 --> 01:36:19,440 THAT THIS INITIATIVE IS GOING 2643 01:36:19,507 --> 01:36:22,209 OUT WITHOUT CLINICAL TRIALS. 2644 01:36:22,276 --> 01:36:23,644 THE LIMITATIONS TO THE PROGRAM 2645 01:36:23,711 --> 01:36:25,713 WERE PERCEIVED TO BE MOSTLY 2646 01:36:25,779 --> 01:36:26,914 FINANCIAL, THAT IF THERE WAS 2647 01:36:26,981 --> 01:36:28,082 MORE FUNDING, THERE COULD BE 2648 01:36:28,149 --> 01:36:29,950 MORE SCIENCE. 2649 01:36:30,017 --> 01:36:32,586 SO IS WE'RE BUYING WHAT WE GET. 2650 01:36:32,653 --> 01:36:34,722 THERE WERE NOT ANY SUGGESTIONS 2651 01:36:34,788 --> 01:36:36,157 OF ANY AREAS OF THE CONSORTIUM 2652 01:36:36,223 --> 01:36:37,892 THAT WE SHOULD DISCONTINUE. 2653 01:36:37,958 --> 01:36:39,994 IT WAS FELT THAT WE SHOULD ALLOW 2654 01:36:40,060 --> 01:36:45,166 THINGS TO MOVE NATURALLY IF 2655 01:36:45,232 --> 01:36:46,367 SOMETHING WERE TO BE NOT 2656 01:36:46,433 --> 01:36:47,468 WORTHWHILE IN THE FUTURE, IT 2657 01:36:47,535 --> 01:36:48,903 COULD JUST DROP OUT, BUT AT THIS 2658 01:36:48,969 --> 01:36:51,605 TIME, THERE WAS NO NEED FOR 2659 01:36:51,672 --> 01:36:53,140 NIAID TO ASK FOR 2660 01:36:53,207 --> 01:36:57,278 DISCONTINUATION. 2661 01:36:57,344 --> 01:36:59,446 SO WE'RE MAINTAINING A LOT OF 2662 01:36:59,513 --> 01:37:00,047 THE FUNDAMENTAL STRUCTURE OF 2663 01:37:00,114 --> 01:37:02,183 IDEA FROM ROUND FOUR TO ROUND 2664 01:37:02,249 --> 01:37:02,750 FIVE. 2665 01:37:02,816 --> 01:37:06,153 THE SENTINEL RESEARCH NETWORKS 2666 01:37:06,220 --> 01:37:09,924 ASSISTED BY NIDDK AND AAA, 2667 01:37:09,990 --> 01:37:11,025 HEART, LUNG AND BLOOD, MENTAL 2668 01:37:11,091 --> 01:37:12,526 HEALTH, THOSE COHORTS WILL 2669 01:37:12,593 --> 01:37:14,595 CONTINUE THE 2670 01:37:14,662 --> 01:37:16,330 TUBERCULOSIS-SPECIFIC SRN WILL 2671 01:37:16,397 --> 01:37:19,166 CONTINUE, THE WORK OF THE 2672 01:37:19,233 --> 01:37:22,436 NATIONAL CANCER INSTITUTE, THE 2673 01:37:22,503 --> 01:37:23,771 SPECIFIC WORK THAT THEY DO 2674 01:37:23,837 --> 01:37:25,506 LINKING TO REGISTRIES AND 2675 01:37:25,573 --> 01:37:29,210 IMPROVING CANCER DIAGNOSIS WILL 2676 01:37:29,276 --> 01:37:31,345 CONTINUE, STUDY THES OF PREGNANT 2677 01:37:31,412 --> 01:37:33,247 WOMEN AND UNEXPOSE AND INFECTED 2678 01:37:33,314 --> 01:37:33,747 CHILDREN ALSO. 2679 01:37:33,814 --> 01:37:35,182 THE FAMILY CYST ON DATA SCIENCE 2680 01:37:35,249 --> 01:37:37,218 AND THE WORK WITH THE NATIONAL 2681 01:37:37,284 --> 01:37:40,588 LIBRARY OF MEDICINE TO INCREASE 2682 01:37:40,654 --> 01:37:43,524 THE FAIRNESS OF OUR DATA, 2683 01:37:43,591 --> 01:37:49,463 FINDABLE, ACCESSIBLE, PUSHING TO 2684 01:37:49,530 --> 01:37:51,432 INCLUDE THAT DATA IN THE NIAID 2685 01:37:51,498 --> 01:37:53,267 DATA ECOSYSTEM, WORKING TO 2686 01:37:53,334 --> 01:37:54,768 DEVELOP EVER BETTER DATA 2687 01:37:54,835 --> 01:37:55,669 VISUALIZATION SO THAT THE 2688 01:37:55,736 --> 01:37:57,171 RESULTS OF THE STUDY ARE CLEAR 2689 01:37:57,238 --> 01:38:00,908 TO ALL POPULATIONS, AND THEN 2690 01:38:00,975 --> 01:38:02,910 MAINTAINING THE FOGARTY LINKS 2691 01:38:02,977 --> 01:38:04,345 FOR OUR TRAINING PROGRAMS AND 2692 01:38:04,411 --> 01:38:07,181 THEIR LINKAGE WITH THEIR VERY 2693 01:38:07,248 --> 01:38:08,849 STRONG D43 PROGRAM, AS WELL AS A 2694 01:38:08,916 --> 01:38:12,519 NEED TO SUPPORT EARLY STAGE 2695 01:38:12,586 --> 01:38:13,821 INVESTIGATORS, PEOPLE AFTER 2696 01:38:13,887 --> 01:38:15,356 THEIR INITIAL TRAINING, AND 2697 01:38:15,422 --> 01:38:17,758 NEEDING SUPPORT TO BE ABLE TO 2698 01:38:17,825 --> 01:38:21,262 MAINTAIN THEIR WORK IN RESEARCH. 2699 01:38:21,328 --> 01:38:23,364 CHANGES FROM FOUR TO FIVE, IT'S 2700 01:38:23,430 --> 01:38:24,765 REALLY MORE JUST A -- I DON'T 2701 01:38:24,832 --> 01:38:26,066 KNOW IF THE WORD CHANGE IS 2702 01:38:26,133 --> 01:38:28,702 APPROPRIATE HERE, BUT WE WILL 2703 01:38:28,769 --> 01:38:30,204 CONTINUE TO COLLECT DATA TO 2704 01:38:30,271 --> 01:38:31,939 IMPROVE GAPS IN DATA COLLECTION, 2705 01:38:32,006 --> 01:38:34,441 PARTICULARLY AS WE ALL KNOW THAT 2706 01:38:34,508 --> 01:38:36,377 PEPFAR IS IN A MOMENT OF 2707 01:38:36,443 --> 01:38:37,945 TRANSITION OR UNCERTAINTY, AND 2708 01:38:38,012 --> 01:38:42,316 BEING SURE THAT IDEA IS ABLE TO 2709 01:38:42,383 --> 01:38:44,952 CONTINUE TO SERVE THE RESEARCH 2710 01:38:45,019 --> 01:38:46,453 AGENDA EVEN WITH THESE 2711 01:38:46,520 --> 01:38:48,222 UNCERTAINTIES WITH PEPFAR. 2712 01:38:48,289 --> 01:38:50,591 THINGS LIKE THE COLLECTION OF 2713 01:38:50,658 --> 01:38:52,526 CD4 AND VIRAL LOADS, DATA ON 2714 01:38:52,593 --> 01:38:52,893 DRUG RESISTANCE. 2715 01:38:52,960 --> 01:38:54,328 THESE ARE THINGSING THAT ARE NOT 2716 01:38:54,395 --> 01:38:55,963 OFTEN AVAILABLE INTERNATIONALLY 2717 01:38:56,030 --> 01:38:57,431 AND IDEA WILL BE THERE TO FILL 2718 01:38:57,498 --> 01:39:01,602 THOSE GAPS. 2719 01:39:01,669 --> 01:39:03,003 REALLY LIKE TO INCREASE THE 2720 01:39:03,070 --> 01:39:04,405 EMPHASIS ON DATA LINKAGES TO 2721 01:39:04,471 --> 01:39:06,607 OTHER DATA SOURCES, THE CANCER 2722 01:39:06,674 --> 01:39:08,909 REGISTRY, THE DEATH REGISTRY, 2723 01:39:08,976 --> 01:39:10,311 UNDERSTANDING HOW PEOPLE ARE 2724 01:39:10,377 --> 01:39:14,181 MOVING AROUND WITHIN A COMMUNITY 2725 01:39:14,248 --> 01:39:15,316 AND CHANGING HEALTHCARE 2726 01:39:15,382 --> 01:39:17,751 SETTINGS. 2727 01:39:17,818 --> 01:39:19,253 WORKING ON THE CREATION OF THE 2728 01:39:19,320 --> 01:39:21,622 MULTIUSE DATASET, WHICH IS THIS 2729 01:39:21,689 --> 01:39:22,856 THIS STANDING DATASET I 2730 01:39:22,923 --> 01:39:24,692 MENTIONED THAT WILL ACCELERATE 2731 01:39:24,758 --> 01:39:26,226 THE WAY THAT IDEA IS ABLE TO GET 2732 01:39:26,293 --> 01:39:30,264 DATA TO INVESTIGATORS, THE 2733 01:39:30,331 --> 01:39:32,199 STANDING DATASET WILL EXIST. 2734 01:39:32,266 --> 01:39:33,133 EXPANDING SUPPORT AND TRAINING 2735 01:39:33,200 --> 01:39:34,535 FOR MID CAREER INVESTIGATORS. 2736 01:39:34,601 --> 01:39:38,005 AND THEN TO CONTINUE TO PUSH AND 2737 01:39:38,072 --> 01:39:39,807 TO SUPPORT IEDEA INVESTIGATORS 2738 01:39:39,873 --> 01:39:42,776 TO GET ANCILLARY GRANT FUNDING, 2739 01:39:42,843 --> 01:39:44,545 NIH GRANTS AREN'T EASY TO GET, 2740 01:39:44,611 --> 01:39:47,247 AND ANY HELP THAT WE CAN GIVE TO 2741 01:39:47,314 --> 01:39:51,719 IMPROVE THEIR WORK IN THAT AREA. 2742 01:39:51,785 --> 01:39:55,489 WE HAD DR. ELAINE ABRAMS AND 2743 01:39:55,556 --> 01:40:04,131 RAPHI LIND V LI LANDOVITZ. 2744 01:40:04,198 --> 01:40:05,399 THEY WERE VERY PLEASED TO SEE 2745 01:40:05,466 --> 01:40:08,535 THE SUCCESS OF TRAINING YOUNG 2746 01:40:08,602 --> 01:40:08,902 INVESTIGATORS. 2747 01:40:08,969 --> 01:40:11,372 THERE WAS SOME CONCERN ABOUT THE 2748 01:40:11,438 --> 01:40:13,307 R24, THE HARMNIST DATA SCIENCE 2749 01:40:13,374 --> 01:40:14,742 PROGRAM, THAT IT IS SUCH AN 2750 01:40:14,808 --> 01:40:16,143 IMPORTANT PART OF THE GROUP BUT 2751 01:40:16,210 --> 01:40:19,279 ACTUALLY FUNDED OUTSIDE OF 2752 01:40:19,346 --> 01:40:19,947 IEDEA. 2753 01:40:20,013 --> 01:40:21,482 HARMNIST WORKS FOR OTHER PEOPLE 2754 01:40:21,548 --> 01:40:22,383 AS WELL. 2755 01:40:22,449 --> 01:40:26,019 THEY ARE CRUCIAL TO IEDEA BUT 2756 01:40:26,086 --> 01:40:26,820 THEY ALSO SUPPORT SOME OTHER 2757 01:40:26,887 --> 01:40:29,690 PROGRAMS SO THEY AREN'T JUST AN 2758 01:40:29,757 --> 01:40:31,225 INSIDE IEDEA GROUP. 2759 01:40:31,291 --> 01:40:32,292 THERE WAS CONCERN ABOUT HOW 2760 01:40:32,359 --> 01:40:35,863 COULD WE CONTINUE TO EVALUATE 2761 01:40:35,929 --> 01:40:38,265 CARE IN THIS UNCERTAIN GLOBAL 2762 01:40:38,332 --> 01:40:38,732 FUNDING ENVIRONMENT. 2763 01:40:38,799 --> 01:40:42,536 I THINK WE NEED TO RELY ON THE U 2764 01:40:42,603 --> 01:40:43,604 COOPERATIVE AGREEMENT MECHANISM 2765 01:40:43,670 --> 01:40:45,205 TO BE ABLE TO BE FLEXIBLE TO 2766 01:40:45,272 --> 01:40:46,874 FIGURE OUT WHERE WE MAY OR MAY 2767 01:40:46,940 --> 01:40:48,409 NOT NEED TO MAKE CHANGES IF 2768 01:40:48,475 --> 01:40:51,512 THERE ARE SUBSTANTIAL 2769 01:40:51,578 --> 01:40:53,881 UNCERTAINTIES. 2770 01:40:53,947 --> 01:40:56,483 THE REVIEWERS WERE EAGER TO SEE 2771 01:40:56,550 --> 01:40:58,452 IEDEA STAY FOCUSED ON THE LARGE 2772 01:40:58,519 --> 01:40:59,186 DATA SCIENCE. 2773 01:40:59,253 --> 01:41:03,223 THEY AGREED THAT CLINICAL TRIALS 2774 01:41:03,290 --> 01:41:04,191 WERE NOT A GOOD DIRECTION FOR 2775 01:41:04,258 --> 01:41:05,826 THE PROGRAM TO CONSIDER GOING, 2776 01:41:05,893 --> 01:41:07,461 AND WE WILL BE SURE THAT THAT'S 2777 01:41:07,528 --> 01:41:09,730 WELL EXPRESSED AND DESCRIBED IN 2778 01:41:09,797 --> 01:41:10,664 THE NOFO. 2779 01:41:10,731 --> 01:41:12,266 THERE WAS SOME CONCERN ABOUT THE 2780 01:41:12,332 --> 01:41:14,201 SPEED AT WHICH IDEA CAN MOVE. 2781 01:41:14,268 --> 01:41:17,171 IT IS A VERY LARGE GROUP, MOVING 2782 01:41:17,237 --> 01:41:18,405 DATA MORE RAPIDLY, GETTING 2783 01:41:18,472 --> 01:41:22,576 RESULTS OUT MORE QUICKLY. 2784 01:41:22,643 --> 01:41:25,245 I THINK NOW IN THE POST-COVID 2785 01:41:25,312 --> 01:41:26,647 WORLD, THE ROLE OF 2786 01:41:26,713 --> 01:41:28,449 PREPUBLICATION RELEASE OF 2787 01:41:28,515 --> 01:41:29,249 INFORMATION, I WAS THINKING 2788 01:41:29,316 --> 01:41:31,318 ABOUT THAT AFTER WE TALKED TO 2789 01:41:31,385 --> 01:41:33,287 THE REVIEWERS, AND WAYS IN WHICH 2790 01:41:33,353 --> 01:41:34,955 WE CAN COMMUNICATE RESULTS IN 2791 01:41:35,022 --> 01:41:37,090 OTHER WAYS. 2792 01:41:37,157 --> 01:41:39,259 IT ALSO WILL REQUIRE, AGAIN, 2793 01:41:39,326 --> 01:41:40,794 MORE EMPHASIS ON THIS DATA 2794 01:41:40,861 --> 01:41:43,230 SCIENCE TO REALLY ACCELERATE THE 2795 01:41:43,297 --> 01:41:44,598 MOVEMENT OF DATA. 2796 01:41:44,665 --> 01:41:46,467 THERE WERE SOME QUESTIONS FROM 2797 01:41:46,533 --> 01:41:48,335 THE REVIEWERS ABOUT BEING ABLE 2798 01:41:48,402 --> 01:41:49,670 TO EXPAND INTO AREAS WHICH WE 2799 01:41:49,736 --> 01:41:51,939 NOW SEE AS SO IMPORTANT, 2800 01:41:52,005 --> 01:41:54,441 INCLUDING PREP AND STI 2801 01:41:54,508 --> 01:41:55,175 EPIDEMIOLOGY AND CARE. 2802 01:41:55,242 --> 01:42:01,114 I THINK THIS AGAIN EMPHASIZES 2803 01:42:01,181 --> 01:42:03,283 THAT IEDEA IS ALREADY A VERY 2804 01:42:03,350 --> 01:42:04,818 WIDE AND BIG PROGRAM, AND 2805 01:42:04,885 --> 01:42:06,119 UNDERSTANDING WHERE TO PUT THE 2806 01:42:06,186 --> 01:42:07,454 FOCUS, THERE IS A LOT OF 2807 01:42:07,521 --> 01:42:08,489 INTEREST FROM THE INVESTIGATORS 2808 01:42:08,555 --> 01:42:11,258 TO MOVE INTO THESE AREAS, BUT 2809 01:42:11,325 --> 01:42:13,293 RESOURCES MAY NOT BE THERE TO 2810 01:42:13,360 --> 01:42:17,231 SUPPORT THAT. 2811 01:42:17,297 --> 01:42:20,133 SO THIS IS THE INTERNATIONAL EPI 2812 01:42:20,200 --> 01:42:21,635 DATABASES TO EVALUATE AIDS. 2813 01:42:21,702 --> 01:42:23,270 AS I MENTIONED IT'S A LIMITED 2814 01:42:23,337 --> 01:42:24,371 COMPETITION FOR FIVE YEARS, AND 2815 01:42:24,438 --> 01:42:29,843 IT WILL BE A MULTI-IC PROGRAM. 2816 01:42:29,910 --> 01:42:30,911 >> THANKS A LOT. 2817 01:42:30,978 --> 01:42:37,251 ARE THERE QUESTIONS IN THE ROOM? 2818 01:42:37,317 --> 01:42:37,918 SEEMA? 2819 01:42:37,985 --> 01:42:40,854 >> THANK YOU, CARLY, THAT WAS A 2820 01:42:40,921 --> 01:42:43,023 REALLY NIGHT PRESENTATION, 2821 01:42:43,090 --> 01:42:44,892 IMPORTANT WORK, TO SUMMARIZE ALL 2822 01:42:44,958 --> 01:42:46,960 OF IT IS HARD, I IMAGINE. 2823 01:42:47,027 --> 01:42:48,262 I'M JUST CURIOUS, I'VE BEEN 2824 01:42:48,328 --> 01:42:49,563 THINKING A LOT ABOUT GLOBAL 2825 01:42:49,630 --> 01:42:52,099 HEALTH EQUITY LATELY, EVEN IN MY 2826 01:42:52,165 --> 01:42:53,934 OWN RESEARCH, AND ONE OF THE 2827 01:42:54,001 --> 01:42:54,968 THINGS THAT INCREASINGLY IS 2828 01:42:55,035 --> 01:42:56,770 COMING UP IS ARE THERE 2829 01:42:56,837 --> 01:42:57,538 OPPORTUNITIES FOR PEOPLE BASED 2830 01:42:57,604 --> 01:43:00,140 IN LOW AND MIDDLE INCOME 2831 01:43:00,207 --> 01:43:01,642 COUNTRIES TO DIRECT RESEARCH 2832 01:43:01,708 --> 01:43:05,312 PRIORITIES AND TO HAVE 2833 01:43:05,379 --> 01:43:06,246 OPPORTUNITIES TO BE FIRST AND 2834 01:43:06,313 --> 01:43:07,614 SENIOR AUTHORS, AND I WASN'T 2835 01:43:07,681 --> 01:43:09,049 SURE IF THE EXTERNAL REVIEW 2836 01:43:09,116 --> 01:43:12,519 LOOKED AT THAT, IF YOU HAVE AN 2837 01:43:12,586 --> 01:43:14,121 OPPORTUNITY TO LOOK AT THE 2838 01:43:14,187 --> 01:43:14,755 PUBLICATIONS THAT HAVE COME OUT 2839 01:43:14,821 --> 01:43:18,525 OF THIS, HOW OFTEN DOES THAT 2840 01:43:18,592 --> 01:43:18,959 HAPPEN? 2841 01:43:19,026 --> 01:43:21,028 AND IT MIGHT BE SOMETHING TO 2842 01:43:21,094 --> 01:43:23,230 THINK ABOUT, MAYBE NOT 2843 01:43:23,297 --> 01:43:26,333 NECESSARILY EXCLUSIVELY NOW BUT 2844 01:43:26,400 --> 01:43:27,301 FOR THE FUTURE? 2845 01:43:27,367 --> 01:43:30,270 >> SO THEY DID DO A HUGE REVIEW 2846 01:43:30,337 --> 01:43:33,807 OF THE PUBLICATIONS. 2847 01:43:33,874 --> 01:43:35,142 ONE OF THE THINGS THEY FOUND IN 2848 01:43:35,208 --> 01:43:37,110 DOING A BIG NETWORK ANALYSIS OF 2849 01:43:37,177 --> 01:43:38,845 THE PUBLICATION IS REGIONS 2850 01:43:38,912 --> 01:43:43,216 PUBLISHED WITHIN REGIONS. 2851 01:43:43,283 --> 01:43:44,851 REALLY SOME OF THE ANALYSES THEY 2852 01:43:44,918 --> 01:43:46,086 DID WASN'T QUITE AS GRIPPING AS 2853 01:43:46,153 --> 01:43:50,724 I HAD HOPED FOR. 2854 01:43:50,791 --> 01:43:55,996 FIRST AUTHORSHIP BY SITES IS -- 2855 01:43:56,063 --> 01:43:57,431 SO ALL DATA BELONG AT THE CLINIC 2856 01:43:57,497 --> 01:43:58,031 LEVEL. 2857 01:43:58,098 --> 01:44:00,033 WHENEVER AN ANALYSIS IS 2858 01:44:00,100 --> 01:44:01,134 REQUESTED, THE REQUEST GOES DOWN 2859 01:44:01,201 --> 01:44:02,302 TO THE CLINIC LEVEL AND SAYS DO 2860 01:44:02,369 --> 01:44:03,704 YOU WANT TO PARTICIPATE IN THIS 2861 01:44:03,770 --> 01:44:04,171 PROJECT. 2862 01:44:04,237 --> 01:44:06,106 SO THE INVESTIGATORS AT THAT 2863 01:44:06,173 --> 01:44:10,344 SITE ARE IN OR OUT. 2864 01:44:10,410 --> 01:44:12,379 ONCE YOU'RE IN ON AN ANALYSIS, 2865 01:44:12,446 --> 01:44:13,013 YOU'RE IN. 2866 01:44:13,080 --> 01:44:14,381 YOU CAN'T DROP OUT LATER BECAUSE 2867 01:44:14,448 --> 01:44:15,716 YOUR CLINIC DOESN'T LOOK GOOD OR 2868 01:44:15,782 --> 01:44:17,017 SOMETHING, BUT YOU'RE IN. 2869 01:44:17,084 --> 01:44:18,485 AND EACH REGION HAS A CERTAIN 2870 01:44:18,552 --> 01:44:21,188 NUMBER OF AUTHORSHIPS ON ANY 2871 01:44:21,254 --> 01:44:23,790 MULTIREGIONAL PROJECT TO ENSURE 2872 01:44:23,857 --> 01:44:24,891 THAT PEOPLE DOWN ALL THE WAY TO 2873 01:44:24,958 --> 01:44:27,995 THE CLINIC LEVEL ARE ABLE TO 2874 01:44:28,061 --> 01:44:29,963 PARTICIPATE. 2875 01:44:30,030 --> 01:44:31,164 SOME SITES ARE VERY SMALL AND 2876 01:44:31,231 --> 01:44:35,802 THEY HAVE A NURSE WHO IS NOT 2877 01:44:35,869 --> 01:44:37,738 ENGAGED IN THE SCIENTIFIC 2878 01:44:37,804 --> 01:44:39,139 PROJECT, BUT THERE IS A VERY 2879 01:44:39,206 --> 01:44:40,574 ACTIVE DEVIER TO PUSH DOWN TO 2880 01:44:40,641 --> 01:44:45,512 THE LOCAL LEVEL. 2881 01:44:45,579 --> 01:44:49,883 THE FOGARTY MEASUREMENT PROGRAM, 2882 01:44:49,950 --> 01:44:54,888 THE FMPERS ARE TWO LUCKY PEOPLE 2883 01:44:54,955 --> 01:44:58,058 PER REGION GET PICKED TO BE THE 2884 01:44:58,125 --> 01:44:58,592 FMPERS. 2885 01:44:58,659 --> 01:45:00,594 THE GOAL IS TO WRITE TWO PAPERS 2886 01:45:00,661 --> 01:45:01,662 AND MAKE PRESENTATIONS. 2887 01:45:01,728 --> 01:45:03,830 THERE IS MONEY AVAILABLE FOR 2888 01:45:03,897 --> 01:45:05,265 THEM TO TRAVEL TO INTERNATIONAL 2889 01:45:05,332 --> 01:45:07,000 MEETINGS, AND PEOPLE WHO ARE 2890 01:45:07,067 --> 01:45:09,536 ABLE TO GO THROUGH THE FMP 2891 01:45:09,603 --> 01:45:13,340 PROGRAM HAVE A GREAT 2892 01:45:13,407 --> 01:45:17,044 OPPORTUNITY, BUT AS ALWAYS, 2893 01:45:17,110 --> 01:45:19,946 THERE ARE -- MAKING IT POSSIBLE 2894 01:45:20,013 --> 01:45:22,282 FOR PEOPLE WHO HAVE TOO MUCH 2895 01:45:22,349 --> 01:45:24,051 WORK AT THE CLINIC LEVEL TO 2896 01:45:24,117 --> 01:45:26,119 ACTUALLY PARTICIPATE ALSO IN 2897 01:45:26,186 --> 01:45:28,422 RESEARCH IS DIFFICULT. 2898 01:45:28,488 --> 01:45:29,489 I THINK EVERYONE IS REALLY 2899 01:45:29,556 --> 01:45:32,559 COMMITTED TO IT, BUT THE REALITY 2900 01:45:32,626 --> 01:45:33,060 OF IT IS DIFFICULT. 2901 01:45:33,126 --> 01:45:35,996 I CAN TRY AND LOOK AT FIRST 2902 01:45:36,063 --> 01:45:37,064 AUTHORSHIPS, BUT WE TALK ABOUT 2903 01:45:37,130 --> 01:45:40,901 IT A LOT. 2904 01:45:40,967 --> 01:45:42,736 >> WE PROBABLY HAVE TIME FOR ONE 2905 01:45:42,803 --> 01:45:46,373 MORE BRIEF QUESTION AND ANSWER. 2906 01:45:46,440 --> 01:45:51,244 ANYONE ONLINE? 2907 01:45:51,311 --> 01:45:53,480 ANYONE ELSE IN THE ROOM? 2908 01:45:53,547 --> 01:45:54,247 NO? 2909 01:45:54,314 --> 01:45:57,117 OKAY. 2910 01:45:57,184 --> 01:45:57,651 SO THANK YOU. 2911 01:45:57,718 --> 01:46:00,053 I'LL ASK EVERYONE TO PLEASE 2912 01:46:00,120 --> 01:46:05,659 VOTE, AND WE WILL TAKE A 2913 01:46:05,726 --> 01:46:08,161 15-MINUTE BREAK, AND WE'LL 2914 01:46:08,228 --> 01:46:11,364 RECONVENE AT 3:00 P.M. 2915 01:46:11,431 --> 01:46:14,801 FOR THE EAST COAST PEOPLE. 2916 01:46:14,868 --> 01:46:15,469 AND APPROPRIATE TIME FOR THE 2917 01:46:15,535 --> 01:46:17,037 REST OF YOU. 2918 01:46:17,104 --> 01:46:21,875 THANKS, EVERYONE. 2919 01:46:21,942 --> 01:46:26,546 THANKS, EVERYONE. 2920 01:46:26,613 --> 01:46:28,849 WE'LL START THE SECOND HALF AND 2921 01:46:28,915 --> 01:46:33,220 INTRODUCE STUART SHAPRIO TO 2922 01:46:33,286 --> 01:46:34,755 INTRODUCE CHAVDI. 2923 01:46:34,821 --> 01:46:36,289 >> HELLO. 2924 01:46:36,356 --> 01:46:40,861 I'M STUART SHAPRIO IN THE 2925 01:46:40,927 --> 01:46:44,131 VACCINE PROGRAM, THE CONSORTIA 2926 01:46:44,197 --> 01:46:47,000 FOR HIV/AIDS VACCINE DEVELOPMENT 2927 01:46:47,067 --> 01:46:48,001 AND IMMUNOLOGY. 2928 01:46:48,068 --> 01:46:49,436 THE OBJECTIVE OF THIS INITIATIVE 2929 01:46:49,503 --> 01:46:53,740 IS TO FUND A COORDINATED 2930 01:46:53,807 --> 01:46:55,842 MULTIDISCIPLINARY EFFORT FOCUSED 2931 01:46:55,909 --> 01:46:58,812 ON BOTH PRE-CLINICAL HIV VACCINE 2932 01:46:58,879 --> 01:47:00,647 DISCOVERY, TRANSLATIONAL VACCINE 2933 01:47:00,714 --> 01:47:04,050 DESIGN AND DEVELOPMENT, CLINICAL 2934 01:47:04,117 --> 01:47:05,452 VACCINE MANUFACTURE, AND 2935 01:47:05,519 --> 01:47:08,622 ULTIMATELY, PROOF OF CONCEPT 2936 01:47:08,688 --> 01:47:10,557 THAT OUR INVESTIGATORS CAN 2937 01:47:10,624 --> 01:47:12,192 INDUCE BROADLY NEUTRALIZING 2938 01:47:12,259 --> 01:47:16,463 ANTIBODIES, OR BNABs, TO AT 2939 01:47:16,530 --> 01:47:17,664 LEAST THREE DIFFERENT BNAB 2940 01:47:17,731 --> 01:47:19,232 TARGETS, AND ALSO INCLUSION OF 2941 01:47:19,299 --> 01:47:20,734 OTHER COOPERATING IMMUNE 2942 01:47:20,801 --> 01:47:21,001 RESPONSES. 2943 01:47:21,067 --> 01:47:23,603 THIS WILL BE A COOPERATIVE 2944 01:47:23,670 --> 01:47:25,472 AGREEMENT. 2945 01:47:25,539 --> 01:47:27,107 THIS IS A NEW INITIATIVE, SO 2946 01:47:27,174 --> 01:47:30,811 ALTHOUGH IT'S A FOLLOW-ON FROM 2947 01:47:30,877 --> 01:47:31,912 THREE PREVIOUS BIG SCIENCE 2948 01:47:31,978 --> 01:47:35,949 FUNDING INITIATIVES, THIS IS A 2949 01:47:36,016 --> 01:47:36,950 CHANGE SCOPE, SO WE'RE CALLING 2950 01:47:37,017 --> 01:47:38,552 IT A NEW INITIATIVE, AND THIS IS 2951 01:47:38,618 --> 01:47:40,353 GOING TO BE FOR AWARDS FOR FIVE 2952 01:47:40,420 --> 01:47:42,722 YEARS WITH A FIRST-YEAR TOTAL 2953 01:47:42,789 --> 01:47:45,592 COST OF $33 MILLION TO FUND TWO 2954 01:47:45,659 --> 01:47:49,362 TO THREE AWARDS. 2955 01:47:49,429 --> 01:47:50,564 SO I HAVE TO START OFF BY 2956 01:47:50,630 --> 01:47:52,365 TELLING YOU HOW WE GOT TO WHERE 2957 01:47:52,432 --> 01:47:54,234 WE ARE, AND WHAT OUR GOAL IS 2958 01:47:54,301 --> 01:47:57,470 WITH THIS NEW INITIATIVE. 2959 01:47:57,537 --> 01:48:00,774 OUR GOAL IS NOT TO DEVELOP THE 2960 01:48:00,841 --> 01:48:01,842 VACCINE, BUT RATHER TO DEVELOP 2961 01:48:01,908 --> 01:48:03,710 THE UNDERLYING SCIENCE, SO THAT 2962 01:48:03,777 --> 01:48:08,715 PHARMA CAN TAKE OVER THE PROCESS 2963 01:48:08,782 --> 01:48:10,984 AND DEVELOP VACCINE PRODUCTS AND 2964 01:48:11,051 --> 01:48:13,787 THE DIVISION OF AIDS ONLY HAS TO 2965 01:48:13,854 --> 01:48:15,989 FUND THE CLINICAL TRIALS NETWORK 2966 01:48:16,056 --> 01:48:17,824 TO TEST THOSE PRODUCTS. 2967 01:48:17,891 --> 01:48:18,692 THIS IS THE WAY THE TREATMENT 2968 01:48:18,758 --> 01:48:21,761 RESEARCH PROGRAM HANDLES 2969 01:48:21,828 --> 01:48:22,729 ANTIRETROVIRAL DRUG DEVELOPMENT. 2970 01:48:22,796 --> 01:48:27,100 WHERE ARE WE IN THE DEVELOPMENT 2971 01:48:27,167 --> 01:48:28,935 OF AN HIV VACCINE THAT 2972 01:48:29,002 --> 01:48:30,537 INTRODUCES BROADLY NEUTRALIZING 2973 01:48:30,604 --> 01:48:31,037 ANTIBODIES? 2974 01:48:31,104 --> 01:48:32,472 WELL, WE'RE ALSO AT THE 2975 01:48:32,539 --> 01:48:33,840 DELINEATION OF THE SCIENCE AND 2976 01:48:33,907 --> 01:48:36,076 PROOF OF CONCEPT FOR THE 2977 01:48:36,142 --> 01:48:38,545 DEVELOPMENT OF A BNAB INDUCING 2978 01:48:38,612 --> 01:48:39,079 HIV VACCINE. 2979 01:48:39,145 --> 01:48:40,213 HOW DID WE GET HERE? 2980 01:48:40,280 --> 01:48:41,348 WE GOT HERE WITH A PORTFOLIO 2981 01:48:41,414 --> 01:48:46,186 THAT INCLUDES THREE ITERATIONS 2982 01:48:46,253 --> 01:48:53,093 OF BIG SCIENCE FUNDING, CHAVI, 2983 01:48:53,159 --> 01:48:54,995 CHAVI-ID AND CHAVD AS WELL AS 2984 01:48:55,061 --> 01:48:56,296 MULTIPLE SMALLER GRANT AND 2985 01:48:56,363 --> 01:48:56,730 CONTRACT PROGRAMS. 2986 01:48:56,796 --> 01:48:58,932 BUT WHAT REMAINS TO BE DONE IS 2987 01:48:58,999 --> 01:49:00,567 PROOF OF SON O'CONNOR SEPTEMBER 2988 01:49:00,634 --> 01:49:02,202 THAT MULTIPLE BNAB LINEAGES CAN 2989 01:49:02,269 --> 01:49:03,970 BE INDUCED, AND WE WANT THEM TO 2990 01:49:04,037 --> 01:49:05,605 BE INDUCED IN PHASE ONE CLINICAL 2991 01:49:05,672 --> 01:49:07,240 TRIALS OR IN A RIGOROUS ANIMAL 2992 01:49:07,307 --> 01:49:10,443 MODEL LIKE NON-HUMAN PRIMATES. 2993 01:49:10,510 --> 01:49:12,846 DEFINITION FOR THE RULES FOR 2994 01:49:12,913 --> 01:49:16,383 SELECTING PRIMES AND BOOSTS FOR 2995 01:49:16,449 --> 01:49:20,220 BNAB INDUCTION, AND ADDITION OF 2996 01:49:20,287 --> 01:49:20,820 COOPERATING IMMUNE RESPONSES. 2997 01:49:20,887 --> 01:49:22,289 SO WHAT IS REQUESTED IS ANOTHER 2998 01:49:22,355 --> 01:49:23,390 FIVE YEARS OF BIG SCIENCE 2999 01:49:23,456 --> 01:49:25,792 FUNDING. 3000 01:49:25,859 --> 01:49:27,794 SO I HAVE TO EXPLAIN THE ROLE 3001 01:49:27,861 --> 01:49:31,498 THAT CHAVD PLAYS IN THE 3002 01:49:31,564 --> 01:49:36,069 LANDSCAPE OF HIV VACCINE PROG 3003 01:49:36,136 --> 01:49:38,338 PROGRAMS WE HAVE MULTIPLE WAYS 3004 01:49:38,405 --> 01:49:39,539 FOR FUNDING PRE-CLINICAL 3005 01:49:39,606 --> 01:49:40,040 RESEARCH. 3006 01:49:40,106 --> 01:49:43,310 WE HAVE MULTIPLE WAYS FOR 3007 01:49:43,376 --> 01:49:44,044 FUNDING MANUFACTURE AND 3008 01:49:44,110 --> 01:49:44,911 TRANSLATIONAL RESEARCH, AND WE 3009 01:49:44,978 --> 01:49:47,347 HAVE SOME CLINICAL TRIALS 3010 01:49:47,414 --> 01:49:51,184 NETWORKS THAT ARE EITHER FUNDED 3011 01:49:51,251 --> 01:49:53,620 BY US OR AFFILIATED TO DO 3012 01:49:53,687 --> 01:49:53,987 CLINICAL TRIALS. 3013 01:49:54,054 --> 01:49:55,789 WE ONLY HAVE ONE MECHANISM, AND 3014 01:49:55,855 --> 01:49:58,091 THAT'S CHAVD, THAT ALLOWS AN 3015 01:49:58,158 --> 01:50:02,295 INVESTIGATOR TO GO FROM AN IDEA 3016 01:50:02,362 --> 01:50:03,363 ALL THE WAY THROUGH THE 3017 01:50:03,430 --> 01:50:06,232 DEVELOPMENT OF THAT IDEA 3018 01:50:06,299 --> 01:50:08,101 PRECLINICALLY INTO GMP 3019 01:50:08,168 --> 01:50:09,502 MANUFACTURE TO DELIVER PRODUCTS 3020 01:50:09,569 --> 01:50:11,905 TO THE HVTN FOR CLINICAL TRIALS. 3021 01:50:11,972 --> 01:50:22,082 AND THAT IS CHAVD. 3022 01:50:22,148 --> 01:50:24,384 SO THE ROLE OF THE CHAVI 3023 01:50:24,451 --> 01:50:25,652 ITERATIONS IN HIV VACCINE 3024 01:50:25,719 --> 01:50:27,520 DEVELOPMENT IS PROFOUND. 3025 01:50:27,587 --> 01:50:30,156 BEFORE WAS THE EMPIRICAL 3026 01:50:30,223 --> 01:50:31,458 APPROACH, THEY WOULD FORMULATE A 3027 01:50:31,524 --> 01:50:33,960 VACCINE BASED ON A REASONABLE 3028 01:50:34,027 --> 01:50:35,695 HYPOTHESIS, THEN CONDUCT PHASE 3029 01:50:35,762 --> 01:50:37,797 ONE, PHASE TWO AND PHASE THREE 3030 01:50:37,864 --> 01:50:39,432 CLINICAL TRIALS, LOOKING FOR AN 3031 01:50:39,499 --> 01:50:42,469 EFFICACY SIGNAL IN PHASE 2B OR 3032 01:50:42,535 --> 01:50:42,702 PHASE 3. 3033 01:50:42,769 --> 01:50:44,237 THEY WOULD THEN PERFORM IMMUNE 3034 01:50:44,304 --> 01:50:46,039 CORRELATES OF PROTECTION 3035 01:50:46,106 --> 01:50:48,008 ANALYSIS USING SAMPLES FROM THAT 3036 01:50:48,074 --> 01:50:53,580 EFFICACY STUDY AND THEN REDESIGN 3037 01:50:53,646 --> 01:50:55,515 THE VACCINE TO ENHANCE THE 3038 01:50:55,582 --> 01:50:56,616 CORRELATIVE IMMUNE RESPONSES AND 3039 01:50:56,683 --> 01:50:58,485 THEN GO BACK TO THE START OF 3040 01:50:58,551 --> 01:50:59,486 CLINICAL DEVELOPMENT WITH PHASE 3041 01:50:59,552 --> 01:51:02,188 1, THEN PHASE 2, THEN PHASE 3042 01:51:02,255 --> 01:51:04,391 3 CLINICAL TRIALS LOOKING FOR AN 3043 01:51:04,457 --> 01:51:06,459 INCREASED EFFICACY SIGNAL IN 3044 01:51:06,526 --> 01:51:08,862 PHASE 3. 3045 01:51:08,928 --> 01:51:11,131 THE DIVISION OF AIDS WITH THE 3046 01:51:11,197 --> 01:51:13,900 COLLABORATION OF OTHERS HAS 3047 01:51:13,967 --> 01:51:15,402 FUNDED SEVEN LARGE SCALE 3048 01:51:15,468 --> 01:51:17,370 EFFICACY STUDIES FOLLOWING THIS 3049 01:51:17,437 --> 01:51:19,139 APPROACH. 3050 01:51:19,205 --> 01:51:23,443 ONLY ONE SHOWED MINIMAL EFFIC 3051 01:51:23,510 --> 01:51:24,644 EFFICACY, AND THE FOLLOW-UP 3052 01:51:24,711 --> 01:51:28,314 TRIAL TO THAT BASED ON THE 3053 01:51:28,381 --> 01:51:29,949 ANALYSIS, CORRELATES ANALYSIS OF 3054 01:51:30,016 --> 01:51:32,619 EFFICACY TRIAL SAMPLES FAILED TO 3055 01:51:32,685 --> 01:51:38,858 SHOW ANY EFFICACY AT ALL. 3056 01:51:38,925 --> 01:51:41,995 SO IN 2003, LEADING HIV VACCINE 3057 01:51:42,062 --> 01:51:44,097 INVESTIGATORS GOT TOGETHER AND 3058 01:51:44,164 --> 01:51:46,499 PUT TOGETHER AN ARTICLE IN 3059 01:51:46,566 --> 01:51:47,801 SCIENCE MAGAZINE THAT CALLED FOR 3060 01:51:47,867 --> 01:51:50,970 A NEW APPROACH TO HIV VACCINE 3061 01:51:51,037 --> 01:51:51,304 DEVELOPMENT. 3062 01:51:51,371 --> 01:51:54,474 THEY CALLED FOR A NEW WAY OF 3063 01:51:54,541 --> 01:51:55,241 THINKING ABOUT PROBLEMS, 3064 01:51:55,308 --> 01:51:58,178 BASICALLY WHAT THEY WERE CALLING 3065 01:51:58,244 --> 01:52:01,781 FOR WAS LARGE SCALE 3066 01:52:01,848 --> 01:52:03,483 COLLABORATIONS TO BREAK THROUGH 3067 01:52:03,550 --> 01:52:05,819 THE BARRIER OF OUR UNDERSTANDING 3068 01:52:05,885 --> 01:52:09,089 TO MAKE AN HIV VACCINE. 3069 01:52:09,155 --> 01:52:12,926 THE DIVISION OF AIDS ROSE THO TO 3070 01:52:12,992 --> 01:52:15,095 THAT CHALLENGE BY FUNDING THE 3071 01:52:15,161 --> 01:52:18,031 CENTER FOR HIV/AIDS VACCINE 3072 01:52:18,098 --> 01:52:18,631 IMMUNOLOGY OR CHA VEE. 3073 01:52:18,698 --> 01:52:29,275 THICHAVI.THIS WAS FUNDED -- WITY 3074 01:52:29,342 --> 01:52:30,710 LARGE BUDGET, $15 MILLION IN THE 3075 01:52:30,777 --> 01:52:33,179 FIRST YEAR, RISING TO ABOUT 3076 01:52:33,246 --> 01:52:34,147 $48 MILLION A YEAR FOR THE 3077 01:52:34,214 --> 01:52:37,317 SUBSEQUENT SIX YEARS. 3078 01:52:37,383 --> 01:52:42,122 PLEASE NOTE THAT THE GOAL WAS 3079 01:52:42,188 --> 01:52:43,690 NOT TO MAKE THE HIV VACCINE. 3080 01:52:43,756 --> 01:52:47,527 THE GOAL WAS TO INVESTIGATE THE 3081 01:52:47,594 --> 01:52:48,928 ROAD BLOCKS TO HIV VACCINE 3082 01:52:48,995 --> 01:52:50,663 DEVELOPMENT AS IN WHY THE 3083 01:52:50,730 --> 01:52:52,098 INITIAL IMMUNE RESPONSE OF 3084 01:52:52,165 --> 01:52:55,602 PEOPLE INFECTED WITH HIV FAILED 3085 01:52:55,668 --> 01:52:58,071 TO CONTROL AND ELIMINATE THE 3086 01:52:58,138 --> 01:53:02,041 VIRUS. 3087 01:53:02,108 --> 01:53:05,678 CHAVI WAS IN IK CYST TENSE FOR 3088 01:53:05,745 --> 01:53:07,514 SEVEN YEARS AND MADE MULTIPLE 3089 01:53:07,580 --> 01:53:08,615 DISCOVERIES THAT LED TO WHAT IS 3090 01:53:08,681 --> 01:53:14,220 NOW THE PATH THAT HIV VA VACCINE 3091 01:53:14,287 --> 01:53:15,054 DEVELOPMENT IS TAKING. 3092 01:53:15,121 --> 01:53:16,289 FIRST OF ALL THEY ENROLLED A 3093 01:53:16,356 --> 01:53:17,824 COHORT OF ABOUT 300 INDIVIDUALS 3094 01:53:17,891 --> 01:53:20,693 WHO HAD BEEN ACUTELY INFECTED. 3095 01:53:20,760 --> 01:53:22,395 THEY FOLLOWED THOSE INDIVIDUALS 3096 01:53:22,462 --> 01:53:24,597 FOR TWO TO FIVE YEARS, AND THIS 3097 01:53:24,664 --> 01:53:26,799 WAS BEFORE THE RECOMMENDATION 3098 01:53:26,866 --> 01:53:29,169 WAS FOR PEOPLE TO BE PUT ON 3099 01:53:29,235 --> 01:53:31,371 TREATMENT AS SOON AS THEY WERE 3100 01:53:31,437 --> 01:53:32,705 DIAGNOSED. 3101 01:53:32,772 --> 01:53:34,107 THEN THE RECOMMENDATION WAS FOR 3102 01:53:34,174 --> 01:53:36,576 PEOPLE TO ONLY BE PUT ON 3103 01:53:36,643 --> 01:53:38,745 TREATMENT WHEN THEIR CD4 COUNT 3104 01:53:38,811 --> 01:53:39,579 DROPPED TO A CERTAIN LEVEL, SO 3105 01:53:39,646 --> 01:53:40,947 MANY OF THESE PEOPLE WERE 3106 01:53:41,014 --> 01:53:43,116 FOLLOWED FOR TWO TO FIVE YEARS 3107 01:53:43,183 --> 01:53:46,986 WITH FREQUENT BLOOD DRAWS SO 3108 01:53:47,053 --> 01:53:47,720 INVESTIGATORS COULD LOOK AT WHAT 3109 01:53:47,787 --> 01:53:49,689 WERE THE IMMUNE RESPONSES AND 3110 01:53:49,756 --> 01:53:52,525 HOW WAS THE VIRUS EVOLVING IN 3111 01:53:52,592 --> 01:53:53,092 RESPONSE TO THOSE IMMUNE 3112 01:53:53,159 --> 01:53:56,496 RESPONSES. 3113 01:53:56,563 --> 01:53:58,331 THIS TRIAL COULD NOT BE REPEATED 3114 01:53:58,398 --> 01:53:59,399 TODAY BECAUSE THAT WOULD BE 3115 01:53:59,465 --> 01:54:00,767 UNETHICAL. 3116 01:54:00,833 --> 01:54:02,936 WHAT CHAVI DISCOVERED WAS THAT 3117 01:54:03,002 --> 01:54:06,072 EARLY IMMUNE RESPONSES PARTIALLY 3118 01:54:06,139 --> 01:54:07,006 BUT DO NOT FULLY CONTROL THE 3119 01:54:07,073 --> 01:54:08,575 VIRUS. 3120 01:54:08,641 --> 01:54:10,944 EARLY CD8 POSITIVE T-CELL 3121 01:54:11,010 --> 01:54:13,413 RESPONSES DID REDUCE INITIAL 3122 01:54:13,479 --> 01:54:16,149 VIREMIA, BUT ESCAPED VARIANTS 3123 01:54:16,216 --> 01:54:18,218 EASILY AND QUICKLY AROSE. 3124 01:54:18,284 --> 01:54:19,919 EARLY NEUTRALIZING ANTIBODY 3125 01:54:19,986 --> 01:54:21,888 RESPONSES WERE NARROWLY TYPE 3126 01:54:21,955 --> 01:54:24,524 SPECIFIC AND ESCAPED FROM EASILY 3127 01:54:24,591 --> 01:54:26,359 ALSO. 3128 01:54:26,426 --> 01:54:29,095 HOWEVER, LATER INFECTION, AFTER 3129 01:54:29,162 --> 01:54:30,763 TWO TO THREE YEARS, MANY PEOPLE, 3130 01:54:30,830 --> 01:54:35,702 10 TO 20% OF PEOPLE, DEVELOPED 3131 01:54:35,768 --> 01:54:37,003 BROADLY NEUTRALIZING ANTIBODIES. 3132 01:54:37,070 --> 01:54:38,204 THESE COULD BE ISOLATED FROM 3133 01:54:38,271 --> 01:54:42,208 THEIR BLOODSTREAM AS MONOCLONAL 3134 01:54:42,275 --> 01:54:44,143 ANTIBODY, AND THOSE MONOCLONAL 3135 01:54:44,210 --> 01:54:45,745 ANTIBODIES WERE STUDIES AND IT 3136 01:54:45,812 --> 01:54:47,614 WAS REALIZED THAT THEY WERE NOT 3137 01:54:47,680 --> 01:54:50,516 IN THE GERMLINE, THEY WERE THE 3138 01:54:50,583 --> 01:54:53,253 RESULT OF SIGNIFICANT AMOUNT OF 3139 01:54:53,319 --> 01:54:55,355 SOMATIC HYPERMUTATION OR 3140 01:54:55,421 --> 01:54:56,990 EVOLUTION OF THE ANTIBODIES IN 3141 01:54:57,056 --> 01:54:58,725 RESPONSE TO THE EVOLUTION OF THE 3142 01:54:58,791 --> 01:55:01,594 VIRUS. 3143 01:55:01,661 --> 01:55:04,330 THIS WAS A BREAKTHROUGH IN OUR 3144 01:55:04,397 --> 01:55:04,764 UNDERSTANDING. 3145 01:55:04,831 --> 01:55:09,669 FROM THIS, THE B CELL 3146 01:55:09,736 --> 01:55:10,803 LINEAGE-BASED HYPOTHESIS WAS 3147 01:55:10,870 --> 01:55:11,871 DEVELOPED. 3148 01:55:11,938 --> 01:55:13,072 SO THE NEW UNDERSTANDING, AND 3149 01:55:13,139 --> 01:55:14,941 THIS WAS BASED ON PRIOR RESEARCH 3150 01:55:15,008 --> 01:55:19,746 DONE AT THE VRC, WHERE THEY HAD 3151 01:55:19,812 --> 01:55:21,414 OBSERVED THE PASSIVE TRANSFER OF 3152 01:55:21,481 --> 01:55:22,715 NEUTRALIZING ANTIBODIES INTO 3153 01:55:22,782 --> 01:55:24,117 NON-HUMAN PRIMATES, WOULD 3154 01:55:24,183 --> 01:55:26,452 PROTECT THOSE NON-HUMAN PRIMATES 3155 01:55:26,519 --> 01:55:34,827 FROM MUCOSAL INFECTION BY SHIV, 3156 01:55:34,894 --> 01:55:41,200 O.HOWEVER, WHAT CHAVI SHOWED WAS 3157 01:55:41,267 --> 01:55:43,403 THAT ANTIHIV BROADLY 3158 01:55:43,469 --> 01:55:44,937 NEUTRALIZING ANTIBODIES ARE NOT 3159 01:55:45,004 --> 01:55:46,472 ENCODED IN THE GERMLINE. 3160 01:55:46,539 --> 01:55:50,443 SO HOW ARE THEY TO BE INDUCED? 3161 01:55:50,510 --> 01:55:53,046 WELL, RARE BNAB PRECURSOR B 3162 01:55:53,112 --> 01:55:55,148 CELLS MUST BE ENGAGED AND 3163 01:55:55,214 --> 01:55:56,683 UNDERGO SOMATIC HYPERMUTATION IN 3164 01:55:56,749 --> 01:56:00,086 THEIR ANTIBODY GENES TO EVOLVE 3165 01:56:00,153 --> 01:56:02,522 INTO ANTIHIV BNABs. 3166 01:56:02,588 --> 01:56:05,191 HIV VACCINE DESIGN THUS 3167 01:56:05,258 --> 01:56:06,292 REQUIRES, ONE, IDENTIFICATION OF 3168 01:56:06,359 --> 01:56:08,394 THE RARE BNAB PRECURSORS THAT 3169 01:56:08,461 --> 01:56:12,131 CAN EVOLVE INTO BNABs, TWO, 3170 01:56:12,198 --> 01:56:13,199 DESIGN OF IMMUNOGEN CONSTRUCTS 3171 01:56:13,266 --> 01:56:16,436 THAT CAN ENGAGE BNAB PRECURSOR, 3172 01:56:16,502 --> 01:56:18,604 AND THREE, DESIGN OF BOOSTING 3173 01:56:18,671 --> 01:56:21,007 IMMUNOGENS THAT CAN GUIDE 3174 01:56:21,074 --> 01:56:22,875 SOMATIC HYPERMUTATION FORMAT 3175 01:56:22,942 --> 01:56:26,679 RANGE OF MOTION OF THOSE INITIAL 3176 01:56:26,746 --> 01:56:28,081 NARROWLY TYPE SPECIFIC 3177 01:56:28,147 --> 01:56:32,118 ANTIBODIES INTO BNABs. 3178 01:56:32,185 --> 01:56:33,720 DR. FAUCI RECOGNIZED THIS AS A 3179 01:56:33,786 --> 01:56:35,154 PARADIGM SHIFT IN THINKING ABOUT 3180 01:56:35,221 --> 01:56:37,223 HIV VACCINE DEVELOPMENT AND 3181 01:56:37,290 --> 01:56:38,658 LABELED IT THE THEORETICAL 3182 01:56:38,725 --> 01:56:41,294 APPROACH. 3183 01:56:41,361 --> 01:56:43,029 SO AS CHAVI WAS COMING TO AN 3184 01:56:43,096 --> 01:56:44,630 END, WE HAD TO DECIDE WHAT TO 3185 01:56:44,697 --> 01:56:47,200 DO, AND WE GOT ADVICE FROM THE 3186 01:56:47,266 --> 01:56:50,370 AVRS, OUR AIDS VACCINE RESEARCH 3187 01:56:50,436 --> 01:56:51,304 SUBCOMMITTEE, THAT NOW WAS THE 3188 01:56:51,371 --> 01:56:53,473 TIME, OR THEN WAS THE TIME, TO 3189 01:56:53,539 --> 01:56:56,743 FUND A LARGE SCALE INITIATIVE IN 3190 01:56:56,809 --> 01:56:59,746 DEVELOPMENT OF THOSE IMMUNOGENS 3191 01:56:59,812 --> 01:57:02,014 THAT COULD INDUCE BNABs. 3192 01:57:02,081 --> 01:57:05,017 AND SO WE DID THAT WITH THE 3193 01:57:05,084 --> 01:57:07,587 CENTER FOR HIV/AIDS VACCINE 3194 01:57:07,653 --> 01:57:12,525 IMMUNOLOGY AND I MU GENERAL IMMN 3195 01:57:12,592 --> 01:57:16,596 DISCOVERY, OR CHAVI-ID, AND THE 3196 01:57:16,662 --> 01:57:22,268 GOAL WAS TO DEVELOP IMMUNOGENS, 3197 01:57:22,335 --> 01:57:24,203 A U19 MECHANISM FOR SEVEN YEARS 3198 01:57:24,270 --> 01:57:26,873 WITH A $31.5 MILLION SETASIDE TO 3199 01:57:26,939 --> 01:57:27,974 FUND ONE TO TWO AWARDS. 3200 01:57:28,040 --> 01:57:31,844 TWO AWARDS WERE FUNDED IN 2012, 3201 01:57:31,911 --> 01:57:34,013 AND THEY WERE EXTREMELY 3202 01:57:34,080 --> 01:57:36,315 PRODUCTIVE BETWEEN 2012 AND 3203 01:57:36,382 --> 01:57:37,316 2019. 3204 01:57:37,383 --> 01:57:40,153 THEY DEFINED THE FIVE ENVELOPE 3205 01:57:40,219 --> 01:57:43,423 PROTEIN TARGET SITES FOR BNAB 3206 01:57:43,489 --> 01:57:43,990 INDUCTION. 3207 01:57:44,056 --> 01:57:47,093 THEY DEFINED MORE BNAB LINEAGES. 3208 01:57:47,160 --> 01:57:49,929 THEY DEFINED THE STRUCTURAL 3209 01:57:49,996 --> 01:57:51,097 SHORTCUT OR REDUCTIONIST 3210 01:57:51,164 --> 01:57:54,600 APPROACH TO BNAB INDUCTION TO 3211 01:57:54,667 --> 01:57:56,335 COMPLEMENT LIN YANK HJ BASED 3212 01:57:56,402 --> 01:57:57,336 DESIGN. 3213 01:57:57,403 --> 01:57:59,739 AND MANY IMMUNOGENS WERE 3214 01:57:59,806 --> 01:58:01,607 DESIGNED AND ANIMAL-TESTED TO 3215 01:58:01,674 --> 01:58:06,212 ENGAGE KNOWN GERMLINE BNAB 3216 01:58:06,279 --> 01:58:07,113 PRECURSORS, AND THE FIRST 3217 01:58:07,180 --> 01:58:08,981 CLINICAL TRIAL TO RECRUIT RARE 3218 01:58:09,048 --> 01:58:11,050 GERMLINE BNAB PRECURSORS IN 3219 01:58:11,117 --> 01:58:13,586 HUMANS WAS SUCCESSFUL. 3220 01:58:13,653 --> 01:58:15,021 SO AS THAT WAS COMING TO AN END, 3221 01:58:15,087 --> 01:58:16,556 WE HAD TO DECIDE WHAT TO FOLLOW 3222 01:58:16,622 --> 01:58:17,990 THAT UP WITH. 3223 01:58:18,057 --> 01:58:20,193 WE DECIDED TO FOLLOW THAT UP 3224 01:58:20,259 --> 01:58:24,230 WITH MORE SEVEN-YEAR BIG SCIENCE 3225 01:58:24,297 --> 01:58:27,099 AWARDS TO ACTUALLY GET THE 3226 01:58:27,166 --> 01:58:30,369 INVESTIGATORS TO DESIGN MORE 3227 01:58:30,436 --> 01:58:32,238 IMMUNOGENS AND MANUFACTURE THEM 3228 01:58:32,305 --> 01:58:33,339 AND GET THEM INTO CLINICAL 3229 01:58:33,406 --> 01:58:35,541 TRIALS. 3230 01:58:35,608 --> 01:58:38,377 ONCE AGAIN, THERE WAS A SETASIDE 3231 01:58:38,444 --> 01:58:41,647 FOR $34.5 MILLION TO FUND ONE TO 3232 01:58:41,714 --> 01:58:42,515 TWO AWARDS. 3233 01:58:42,582 --> 01:58:44,217 AND TWO AWARDS WERE FUNDED. 3234 01:58:44,283 --> 01:58:48,287 AND THOSE ARE TO BE IN EXISTENCE 3235 01:58:48,354 --> 01:58:50,890 FROM 2019 UNTIL 2026, WHICH IS 3236 01:58:50,957 --> 01:58:53,559 TWO MORE YEARS IN THE FUTURE. 3237 01:58:53,626 --> 01:58:55,962 HOWEVER, THEY HAVE BEEN 3238 01:58:56,028 --> 01:58:58,831 INCREDIBLY PRODUCTIVE, EVEN WITH 3239 01:58:58,898 --> 01:59:01,000 THE PROBLEM OF HAVING TO STOP 3240 01:59:01,067 --> 01:59:03,503 AND SUS SPENT RESEARCH PARTIALLY 3241 01:59:03,569 --> 01:59:05,438 DURING THE COVID PANDEMIC. 3242 01:59:05,505 --> 01:59:10,376 THEY HAVE DEVELOPED IMMUNOGENS 3243 01:59:10,443 --> 01:59:15,381 THAT HAVE GONE INTO 11 3244 01:59:15,448 --> 01:59:16,682 EXPERIMENTAL PHASE ONE CLINICAL 3245 01:59:16,749 --> 01:59:18,518 TRIALS THROUGH THE VTN. 3246 01:59:18,584 --> 01:59:21,988 THEY HAVE MANUFACTURED NINE 3247 01:59:22,054 --> 01:59:24,290 DESIGN PRIMING IMMUNOGENS AND 3248 01:59:24,357 --> 01:59:26,392 NINE BOOSTING IMMUNOGENS FOR VTN 3249 01:59:26,459 --> 01:59:26,826 TRIALS. 3250 01:59:26,893 --> 01:59:31,731 THEY HAVE ADDED THE MRNA-LIPID 3251 01:59:31,797 --> 01:59:32,865 NANOPARTICLE PLATFORM TO 3252 01:59:32,932 --> 01:59:34,700 ACCELERATE AND IMPROVE IMMUNOGEN 3253 01:59:34,767 --> 01:59:35,735 DESIGN AND EVALUATION. 3254 01:59:35,801 --> 01:59:38,371 THEY HAVE DEVELOPED MULTIPLE 3255 01:59:38,437 --> 01:59:39,539 KNOCK-IN MOUSE MODELS FOR 3256 01:59:39,605 --> 01:59:42,475 TESTING BNAB INDUCING 3257 01:59:42,542 --> 01:59:43,242 IMMUNOGENS, AND THESE ARE NOT 3258 01:59:43,309 --> 01:59:44,710 JUST BEING USED BY THESE TWO 3259 01:59:44,777 --> 01:59:47,914 GROUPS, BUT THEY'RE ALSO BEING 3260 01:59:47,980 --> 01:59:50,249 USED BY HIV VACCINE DEVELOPERS 3261 01:59:50,316 --> 01:59:51,517 AROUND THE COUNTRY AND AROUND 3262 01:59:51,584 --> 01:59:56,455 THE WORLD INDEED. 3263 01:59:56,522 --> 01:59:58,724 THEY HAVE DESIGNED PRIMING AND 3264 01:59:58,791 --> 01:59:59,859 BOOSTING IMMUNOGENS TO ENGAGE 3265 01:59:59,926 --> 02:00:02,161 4 OF THE 5 BNAB TARGET SITES, 3266 02:00:02,228 --> 02:00:05,531 AND THEY'VE ALSO DEVELOPED THE 3267 02:00:05,598 --> 02:00:07,967 SLOW AND/OR FRACTIONATED DOSING 3268 02:00:08,034 --> 02:00:09,936 REGIMENS THAT HAVE BEEN SHOWN TO 3269 02:00:10,002 --> 02:00:11,370 PROMOTE GERMINAL CENTER 3270 02:00:11,437 --> 02:00:13,105 DEVELOPMENT AND SOMATIC 3271 02:00:13,172 --> 02:00:14,540 HYPERMUTATION IN ANIMALS, AND 3272 02:00:14,607 --> 02:00:17,209 THOSE REGIMENS HAVE GOTTEN IN TO 3273 02:00:17,276 --> 02:00:20,046 HVTN CLINICAL TRIALS. 3274 02:00:20,112 --> 02:00:22,248 SO WHAT WE WERE PROPOSING FOR 3275 02:00:22,315 --> 02:00:27,987 THE SCOPE OF THIS NEW 3276 02:00:28,054 --> 02:00:32,191 INITIATIVE, CHAVDI, THESE ARE 3277 02:00:32,258 --> 02:00:32,825 THE TWO MOST IMPORTANT POINTS OF 3278 02:00:32,892 --> 02:00:33,092 THE SCOPE. 3279 02:00:33,159 --> 02:00:34,427 FIRST OF ALL, WE WANT THEM TO 3280 02:00:34,493 --> 02:00:38,030 DESIGN THE RULES FOR PRIME AND 3281 02:00:38,097 --> 02:00:40,199 BOOST IMMUNOGEN DESIGN. 3282 02:00:40,266 --> 02:00:41,567 THIS HAS TO BE TURNED INTO A 3283 02:00:41,634 --> 02:00:41,901 SCIENCE. 3284 02:00:41,968 --> 02:00:44,604 RIGHT NOW THEY'RE JUST 3285 02:00:44,670 --> 02:00:47,573 CONSTRUCTING MULTIPLE CONSTRUCTS 3286 02:00:47,640 --> 02:00:50,009 FOR EACH BNAB TARGET. 3287 02:00:50,076 --> 02:00:51,177 THEY'RE TAKING THEM THROUGH 3288 02:00:51,243 --> 02:00:54,113 MULTIPLE ROUNDS OF TESTING IN 3289 02:00:54,180 --> 02:00:56,782 MOUSE MODELS, IN NON-HUMAN 3290 02:00:56,849 --> 02:00:57,750 PRIMATES BEFORE THEY GET THEM 3291 02:00:57,817 --> 02:00:59,452 INTO HUMANS. 3292 02:00:59,518 --> 02:01:01,420 THIS IS EXTREMELY LABORIOUS. 3293 02:01:01,487 --> 02:01:03,556 THIS IS NOT SOMETHING THAT 3294 02:01:03,623 --> 02:01:05,358 INDUSTRY WILL EVER TAKE OVER. 3295 02:01:05,424 --> 02:01:07,893 SO WE WANT THEM TO WORK OUT THE 3296 02:01:07,960 --> 02:01:09,395 SCIENCE BEHIND THIS, TO 3297 02:01:09,462 --> 02:01:11,030 UNDERSTAND THE INTERPLAY BETWEEN 3298 02:01:11,097 --> 02:01:16,102 B CELL FREQUENCY, IMMUNOGENICITY 3299 02:01:16,168 --> 02:01:17,903 AND DOSE TO RATIONALLY SELECT 3300 02:01:17,970 --> 02:01:19,872 PRIMING AND BOOSTING IMMUNOGENS. 3301 02:01:19,939 --> 02:01:22,708 SO THAT OTHER PEOPLE CAN DO 3302 02:01:22,775 --> 02:01:23,042 THIS. 3303 02:01:23,109 --> 02:01:24,777 WE ALSO NEED THEM TO UNDERSTAND 3304 02:01:24,844 --> 02:01:27,546 THE DYNAMICS OF GERMINAL CENTER 3305 02:01:27,613 --> 02:01:30,383 MAINTENANCE AND BOOST TIMING, 3306 02:01:30,449 --> 02:01:33,119 AND THEN WE WANT THEM TO GO ON 3307 02:01:33,185 --> 02:01:37,123 FOR FROM UNDERSTANDING THE 3308 02:01:37,189 --> 02:01:40,926 SCIENCE TO ACTUAL DESIGN, GMP 3309 02:01:40,993 --> 02:01:42,028 MANUFACTURE AND GET INTO 3310 02:01:42,094 --> 02:01:43,129 CLINICAL TRIALS THE TESTING OF 3311 02:01:43,195 --> 02:01:45,464 MORE PRIMING AND BOOSTING 3312 02:01:45,531 --> 02:01:46,866 IMMUNOGENS TO UNDERSTAND HOW TO 3313 02:01:46,932 --> 02:01:50,102 GUIDE SOMATIC HYPERMUTATION OF 3314 02:01:50,169 --> 02:01:53,072 MULTIPLE BNAB LINEAGES AT THE 3315 02:01:53,139 --> 02:01:55,141 SAME TIME WITHOUT INTERFERENCE, 3316 02:01:55,207 --> 02:01:56,475 AND TO ACTUALLY DEMONSTRATE THAT 3317 02:01:56,542 --> 02:01:59,211 THEY CAN GET TO A REASONABLE 3318 02:01:59,278 --> 02:02:01,681 TITER OF BROADLY NEUTRALIZING 3319 02:02:01,747 --> 02:02:02,915 ANTIBODIES. 3320 02:02:02,982 --> 02:02:03,516 NEUTRALIZING ANTIBODIES THAT 3321 02:02:03,582 --> 02:02:07,920 WILL NEUTRALIZE AT LEAST 50% OF 3322 02:02:07,987 --> 02:02:11,023 THE GLOBAL -- HIV ISOLATES. 3323 02:02:11,090 --> 02:02:12,491 AND WE WANT THEM TO DO THAT IN 3324 02:02:12,558 --> 02:02:14,393 EITHER A RIGOROUS NON-HUMAN 3325 02:02:14,460 --> 02:02:18,798 PRIMATE MODEL OR IN PHASE ONE 3326 02:02:18,864 --> 02:02:19,498 CLINICAL TRIALS. 3327 02:02:19,565 --> 02:02:21,033 AND WE ALSO WANT THEM TO HARNESS 3328 02:02:21,100 --> 02:02:22,668 THE TECHNOLOGY TO COMBINE PRIMES 3329 02:02:22,735 --> 02:02:25,438 AND BOOSTS IN SIMPLIFIED OR 3330 02:02:25,504 --> 02:02:26,739 SINGLE SHOT REGIMENS. 3331 02:02:26,806 --> 02:02:27,840 WE KNOW THERE ARE PEOPLE THAT 3332 02:02:27,907 --> 02:02:29,408 ARE WORKING ON THESE 3333 02:02:29,475 --> 02:02:32,611 TECHNOLOGIES. 3334 02:02:32,678 --> 02:02:33,879 BUT WE WANT TO EXPAND THE SCOPE 3335 02:02:33,946 --> 02:02:35,414 A LITTLE BIT MORE. 3336 02:02:35,481 --> 02:02:38,851 WE WANT THEM TO EXPAND THE SCOPE 3337 02:02:38,918 --> 02:02:40,820 TO WORK ON THERAPEUTIC HIV 3338 02:02:40,886 --> 02:02:47,293 VACCINE RESEARCH. 3339 02:02:47,359 --> 02:02:48,594 WE USE SOME OF THE SAME PRODUCTS 3340 02:02:48,661 --> 02:02:51,297 THAT THEY ARE DESIGNING FOR 3341 02:02:51,363 --> 02:02:52,565 PREVENTIVE VACCINES, BUT WE WANT 3342 02:02:52,631 --> 02:02:54,867 THEM TO WORK WITH THE 3343 02:02:54,934 --> 02:02:55,601 THERAPEUTIC VACCINE PEOPLE TO 3344 02:02:55,668 --> 02:02:57,670 GET THESE INTO TESTING IN PEOPLE 3345 02:02:57,737 --> 02:02:58,738 WHO ARE LIVING WITH HIV. 3346 02:02:58,804 --> 02:03:00,940 BECAUSE WE WANT TO SEE HOW THESE 3347 02:03:01,006 --> 02:03:02,675 PERFORM IN PEOPLE WHO HAVE 3348 02:03:02,742 --> 02:03:05,177 ALREADY BEEN PRIMED TO HIV 3349 02:03:05,244 --> 02:03:05,444 ANTIGENS. 3350 02:03:05,511 --> 02:03:08,114 THIS IS THE HARDEST CASE 3351 02:03:08,180 --> 02:03:10,883 SCENARIO. 3352 02:03:10,950 --> 02:03:13,652 AND WE CAN CONTRIBUTE -- OUR 3353 02:03:13,719 --> 02:03:16,789 INVESTIGATORS IN CHAVDI CAN 3354 02:03:16,856 --> 02:03:19,125 CONTRIBUTE TO THE THERAPEUTIC 3355 02:03:19,191 --> 02:03:20,960 VACCINE PEOPLE THEIR GMP 3356 02:03:21,026 --> 02:03:24,897 MANUFACTURING CAPABILITY, BUT WT 3357 02:03:24,964 --> 02:03:30,536 THEY, BUTTHEY CAN GET AN EARLY N 3358 02:03:30,603 --> 02:03:31,771 HOW WELL THESE PRODUCTS DO IN 3359 02:03:31,837 --> 02:03:33,005 PEOPLE AND AN EARLY READ ON 3360 02:03:33,072 --> 02:03:34,640 WHETHER OR NOT THE IMMUNE 3361 02:03:34,707 --> 02:03:36,408 RESPONSES THAT THESE PRODUCTS 3362 02:03:36,475 --> 02:03:39,145 WILL INDUCE WILL ACTUALLY IMPACT 3363 02:03:39,211 --> 02:03:41,647 THE COURSE OF INFECTION. 3364 02:03:41,714 --> 02:03:45,184 WE ALSO WANT THEN TO BE ABLE TO 3365 02:03:45,251 --> 02:03:48,654 WORK ON OTHER COOPERATING IMMUNE 3366 02:03:48,721 --> 02:03:49,688 RESPONSES, PROOF THAT OTHER 3367 02:03:49,755 --> 02:03:51,724 IMMUNE RESPONSES WILL COOPERATE 3368 02:03:51,791 --> 02:03:56,295 WITH BNABs, TO ALLOW LOWER 3369 02:03:56,362 --> 02:03:58,130 TITERS TO BE PROTECTED, BUT NOT 3370 02:03:58,197 --> 02:03:59,799 JUST PROOF OF THAT IN A 3371 02:03:59,865 --> 02:04:01,567 NON-HUMAN PRIMATE CHALLENGE 3372 02:04:01,634 --> 02:04:02,868 MODEL BUT WE WANT THEM TO DIG 3373 02:04:02,935 --> 02:04:04,170 MORE DEEPLY INTO THAT TO 3374 02:04:04,236 --> 02:04:05,371 DETERMINE THE MECHANISTIC 3375 02:04:05,437 --> 02:04:07,540 CORRELATE OF THIS COOPERATION. 3376 02:04:07,606 --> 02:04:09,608 SO THAT WE KNOW WHAT TO MEASURE 3377 02:04:09,675 --> 02:04:11,544 IN PHASE ONE CLINICAL STUDIES, 3378 02:04:11,610 --> 02:04:15,648 AND WHAT TO OPTIMIZE IN PHASE 3379 02:04:15,714 --> 02:04:18,751 TWO STUDIES BEFORE EFFICACY 3380 02:04:18,818 --> 02:04:22,922 STUDIES TO AVOID RETURNING TO 3381 02:04:22,988 --> 02:04:23,889 RISKY EMPIRICAL VACCINE 3382 02:04:23,956 --> 02:04:24,190 DEVELOPMENT. 3383 02:04:24,256 --> 02:04:25,891 WHAT WILL NOT BE ALLOWED IS 3384 02:04:25,958 --> 02:04:27,092 APPLICATIONS JUST FOCUSED ON 3385 02:04:27,159 --> 02:04:28,627 THERAPEUTIC HIV VACCINE RESEARCH 3386 02:04:28,694 --> 02:04:29,762 OR ON APPLICATIONS JUST FOCUSED 3387 02:04:29,829 --> 02:04:31,497 ON T-CELL OR OTHER COOPERATING 3388 02:04:31,564 --> 02:04:33,165 IMMUNE RESPONSES. 3389 02:04:33,232 --> 02:04:36,602 SO WE HAD THIS PRE-REVIEWED BY 3390 02:04:36,669 --> 02:04:40,206 TWO ARAC MEMBERS, DR. CYNTHIA 3391 02:04:40,272 --> 02:04:43,409 DERDEYN, WHO IS ON THE LINE, AND 3392 02:04:43,475 --> 02:04:45,578 DR. REUBEN HARRIS, WHO MAY JOIN 3393 02:04:45,644 --> 02:04:47,813 BUT HE'S AT A CONFERENCE IN 3394 02:04:47,880 --> 02:04:49,348 CHINA SO HE MAY NOT JOIN. 3395 02:04:49,415 --> 02:04:51,116 THE REVIEWERS WERE GENERALLY 3396 02:04:51,183 --> 02:04:52,418 SUPPORTIVE OF THE INITIATIVE, 3397 02:04:52,484 --> 02:04:55,421 AND WE THANK THEM FOR THEIR 3398 02:04:55,487 --> 02:04:58,057 CONSTRUCTIVE FEEDBACK. 3399 02:04:58,123 --> 02:04:59,892 ONE OF THE THINGS THAT WAS SAID 3400 02:04:59,959 --> 02:05:02,261 WAS THAT OVERALL CHAVDI SERVES 3401 02:05:02,328 --> 02:05:03,762 AS A FLAGSHIP WITH HIGH 3402 02:05:03,829 --> 02:05:05,397 VISIBILITY WITHIN THE PORTFOLIO 3403 02:05:05,464 --> 02:05:07,700 OF THE VACCINE RESEARCH PROGRAM 3404 02:05:07,766 --> 02:05:10,302 THAT IS CRITICAL FOR SUCCESS. 3405 02:05:10,369 --> 02:05:12,137 THERE IS AN UNEQUIVOCAL NEED FOR 3406 02:05:12,204 --> 02:05:13,105 THE SCIENCE THAT WILL BE 3407 02:05:13,172 --> 02:05:15,608 SUPPORTED BY THIS PROGRAM. 3408 02:05:15,674 --> 02:05:18,143 ALSO, AN IMPORTANT ASPECT OF 3409 02:05:18,210 --> 02:05:20,913 CHAVDI WILL BE THE FOCUS ON 3410 02:05:20,980 --> 02:05:22,114 TRANSLATABILITY OF THE 3411 02:05:22,181 --> 02:05:23,883 SUCCESSFUL VACCINE APPROACHES 3412 02:05:23,949 --> 02:05:26,385 INTO CLINICAL MANUFACTURING AND 3413 02:05:26,452 --> 02:05:27,920 TESTING. 3414 02:05:27,987 --> 02:05:30,489 BUT ON THE LESS POSITIVE SIDE, 3415 02:05:30,556 --> 02:05:32,291 THEY SAID THAT APPLICANTS SHOULD 3416 02:05:32,358 --> 02:05:34,326 PROVIDE CLEAR MILESTONES HALFWAY 3417 02:05:34,393 --> 02:05:35,628 AND FULL TERM MILESTONES, AND 3418 02:05:35,694 --> 02:05:38,831 THEY SHOULD BE HELD ACCOUNTABLE. 3419 02:05:38,898 --> 02:05:40,132 WELL, THIS IS NATURAL TO ASSUME 3420 02:05:40,199 --> 02:05:41,333 BECAUSE WE'RE GIVING THEM SO 3421 02:05:41,400 --> 02:05:44,737 MUCH MONEY, AND WE EXPECT MORE 3422 02:05:44,803 --> 02:05:45,170 ACCOUNTABILITY FROM 3423 02:05:45,237 --> 02:05:46,138 INVESTIGATORS THAT ARE WORKING 3424 02:05:46,205 --> 02:05:47,740 WITH A LARGE CHUNK OF MONEY THAN 3425 02:05:47,806 --> 02:05:49,308 WE EXPECT FROM INVESTIGATORS 3426 02:05:49,375 --> 02:05:51,610 WORKING WITH SMALLER CHUNKS OF 3427 02:05:51,677 --> 02:05:52,311 MONEY. 3428 02:05:52,378 --> 02:05:56,315 SO WE WILL INSTITUTE A CRITICAL 3429 02:05:56,382 --> 02:05:57,983 REVIEW AT THE END OF THE THIRD 3430 02:05:58,050 --> 02:06:02,154 YEAR OF THE FIVE YEARS, AND THE 3431 02:06:02,221 --> 02:06:04,423 LEVEL OF FUNDING IN YEARS FOUR 3432 02:06:04,490 --> 02:06:06,091 AND FIVE WILL DEPEND ON THE 3433 02:06:06,158 --> 02:06:11,997 SUCCESS OF THAT REVIEW. 3434 02:06:12,064 --> 02:06:15,200 ANOTHER COMMENT WAS MADE, SINCE 3435 02:06:15,267 --> 02:06:16,735 THE GOAL IS DURABLE PROTECTION 3436 02:06:16,802 --> 02:06:19,405 OF UNINFECTED PEOPLE FROM NEW 3437 02:06:19,471 --> 02:06:22,174 HIV INFECTIONS, THE MECHANISM 3438 02:06:22,241 --> 02:06:23,475 SHOULD ALLOW FOR OTHER 3439 02:06:23,542 --> 02:06:24,843 INNOVATIVE AFFINITY-BASED 3440 02:06:24,910 --> 02:06:25,778 APPROACHES TO PREVENT INFORECAST 3441 02:06:25,844 --> 02:06:29,415 SHUCH AS NANOPARTICLES. 3442 02:06:29,481 --> 02:06:30,449 WELL, WE THOUGHT ABOUT THIS. 3443 02:06:30,516 --> 02:06:31,517 WE ARE SUPPORTING THE 3444 02:06:31,583 --> 02:06:32,785 DEVELOPMENT OF THOSE SUCH 3445 02:06:32,851 --> 02:06:34,753 PRODUCTS THROUGH OTHER 3446 02:06:34,820 --> 02:06:36,455 MECHANISMS. 3447 02:06:36,522 --> 02:06:38,424 AND WE THINK THAT THE JOB OF 3448 02:06:38,490 --> 02:06:42,628 CHAVD TO DEVELOP THE SCIENCE OF 3449 02:06:42,695 --> 02:06:46,465 BE NAB INDUCTION IS IMPORTANT 3450 02:06:46,532 --> 02:06:47,766 ENOUGH AND IS GOING TO BE ENOUGH 3451 02:06:47,833 --> 02:06:50,669 WORK THAT WE DON'T WANT THEM TO 3452 02:06:50,736 --> 02:06:52,071 BE DISTRACTED BY STUFF THAT 3453 02:06:52,137 --> 02:06:54,807 WE'RE FUNDING WITH OTHER 3454 02:06:54,873 --> 02:06:57,977 INITIATIVES. 3455 02:06:58,043 --> 02:06:59,778 SO I RETURN TO THE INITIAL 3456 02:06:59,845 --> 02:07:01,046 INITIATIVE SLIDE, THE CONSORTIUM 3457 02:07:01,113 --> 02:07:04,383 FOR HIV VACCINE DEVELOPMENT AND 3458 02:07:04,450 --> 02:07:05,351 IMMUNOLOGY, AND I'VE LAID OUT 3459 02:07:05,417 --> 02:07:07,052 WHAT THE OBJECTIVE IS. 3460 02:07:07,119 --> 02:07:09,888 IT'S GOING TO BE A COOPERATIVE 3461 02:07:09,955 --> 02:07:12,291 AGREEMENT, FIVE-YEAR AWARDS WITH 3462 02:07:12,358 --> 02:07:13,325 $33 MILLION SETASIDE FOR TWO TO 3463 02:07:13,392 --> 02:07:15,427 THREE AWARDS. 3464 02:07:15,494 --> 02:07:18,397 SO THANK YOU FOR LISTEN NG. 3465 02:07:18,464 --> 02:07:19,465 ING. 3466 02:07:19,531 --> 02:07:21,867 I'I'LL TAKE QUESTIONS. 3467 02:07:21,934 --> 02:07:24,636 >> WHO WOULD LIKE TO START WITH 3468 02:07:24,703 --> 02:07:25,237 QUESTIONS? 3469 02:07:25,304 --> 02:07:32,878 ANYONE IN THE ROOM? 3470 02:07:32,945 --> 02:07:37,316 RM I DOI DON'T SEE ANYONE ONLIN. 3471 02:07:37,383 --> 02:07:37,983 CINDY, GO AHEAD. 3472 02:07:38,050 --> 02:07:38,417 >> YES. 3473 02:07:38,484 --> 02:07:40,486 THANKS SO MUCH, STUART. 3474 02:07:40,552 --> 02:07:41,854 THAT WAS A NICE PRESENTATION. 3475 02:07:41,920 --> 02:07:44,523 I JUST SORT OF WANTED TO 3476 02:07:44,590 --> 02:07:49,995 REITERATE THAT I THINK THERE 3477 02:07:50,062 --> 02:07:52,464 SHOULD BE SOME LIMITS ON 3478 02:07:52,531 --> 02:07:52,998 REPEATING THINGS THAT HAVE 3479 02:07:53,065 --> 02:07:54,533 ALREADY BEEN DONE, YOU KNOW, 3480 02:07:54,600 --> 02:07:59,705 THINGS LIKE BNAB KNOCK-IN MICE, 3481 02:07:59,772 --> 02:08:01,273 THAT'S BEEN DONE SORT OF 3482 02:08:01,340 --> 02:08:01,607 EXHAUSTIVELY. 3483 02:08:01,673 --> 02:08:02,808 I THINK PROPOSING THAT IN THIS 3484 02:08:02,875 --> 02:08:06,378 NEW INITIATIVE WOULD NOT BE A 3485 02:08:06,445 --> 02:08:07,946 MAJOR ADVANCEMENT, AND I THINK, 3486 02:08:08,013 --> 02:08:12,985 YOU KNOW, FINDING NEW BNABs 3487 02:08:13,052 --> 02:08:14,620 AND WE HAVE SO MANY NOW, SO I 3488 02:08:14,686 --> 02:08:16,555 THINK HAVING SOME LIMITATION OR 3489 02:08:16,622 --> 02:08:18,490 ENCOURAGING SOMEWHERE IN THE 3490 02:08:18,557 --> 02:08:19,391 ANNOUNCEMENT THAT WE'RE NOT JUST 3491 02:08:19,458 --> 02:08:20,793 GOING TO REPEAT THE THINGS THAT 3492 02:08:20,859 --> 02:08:24,129 HAVE BEEN DONE BUT REALLY GOING 3493 02:08:24,196 --> 02:08:25,664 TO ADVANCE AND BUILD ON WHAT'S 3494 02:08:25,731 --> 02:08:28,300 BEEN DONE, YOU KNOW, IN THE -- 3495 02:08:28,367 --> 02:08:32,004 PROBABLY MOSTLY IN THE LAST -- 3496 02:08:32,071 --> 02:08:33,172 BUT IN THE FIELD GOING FORWARD. 3497 02:08:33,238 --> 02:08:36,475 BECAUSE I THINK SOME OF THOSE 3498 02:08:36,542 --> 02:08:39,578 ARE -- THEY'RE EASY TO DO BUT 3499 02:08:39,645 --> 02:08:40,579 THEY'RE NOT GOING TO ADVANCE TO 3500 02:08:40,646 --> 02:08:42,181 WHERE I THINK THAT YOU WANT THIS 3501 02:08:42,247 --> 02:08:44,483 TO GO. 3502 02:08:44,550 --> 02:08:47,352 >> SO I COMPLETELY AGREE WITH 3503 02:08:47,419 --> 02:08:49,254 YOU, AND IF YOU WILL HAVE 3504 02:08:49,321 --> 02:08:50,889 NOTICED -- YOU WILL HAVE NOTICED 3505 02:08:50,956 --> 02:08:53,692 FROM THE SUBSEQUENT -- FROM EACH 3506 02:08:53,759 --> 02:08:56,495 ITERATION AND EACH ITERATION 3507 02:08:56,562 --> 02:08:58,597 INITIATIVE SLIDE, WE'RE ASKING 3508 02:08:58,664 --> 02:09:00,265 THEM TO DO MORE, BECAUSE THEIR 3509 02:09:00,332 --> 02:09:01,900 MISSION EVOLVES AS THE SCIENCE 3510 02:09:01,967 --> 02:09:07,506 HAS EVOLVED. 3511 02:09:07,573 --> 02:09:09,174 WE DON'T WANT THEM TO GO BACK TO 3512 02:09:09,241 --> 02:09:10,776 MAKING MORE KNOCK-IN MOUSE 3513 02:09:10,843 --> 02:09:13,579 MODELS OR ISOLATING MORE BROADLY 3514 02:09:13,645 --> 02:09:14,546 NEUTRALIZING MONOCLONAL 3515 02:09:14,613 --> 02:09:15,013 ANTIBODIES. 3516 02:09:15,080 --> 02:09:15,781 THEY CERTAINLY HAVE ENOUGH OF 3517 02:09:15,848 --> 02:09:16,181 THOSE. 3518 02:09:16,248 --> 02:09:18,016 WE WANT THEM TO FOCUS IN THIS 3519 02:09:18,083 --> 02:09:20,085 NEXT ITERATION ON THE GMP 3520 02:09:20,152 --> 02:09:21,186 MANUFACTURING OF PRODUCTS THAT 3521 02:09:21,253 --> 02:09:25,390 WILL BE DLIMPED DELIVERED TO THN 3522 02:09:25,457 --> 02:09:26,758 BECAUSE WE WANT THEM TO PROVE 3523 02:09:26,825 --> 02:09:27,926 THE CONCEPT IN PHASE ONE 3524 02:09:27,993 --> 02:09:29,061 CLINICAL TRIALS THAT THEY CAN 3525 02:09:29,128 --> 02:09:31,997 INDUCE BNABs. 3526 02:09:32,064 --> 02:09:33,699 AND WE WANT THEM TO WORK OUT THE 3527 02:09:33,765 --> 02:09:35,000 SCIENCE BECAUSE THEY WILL HAVE 3528 02:09:35,067 --> 02:09:36,969 TESTED SO MANY DIFFERENT 3529 02:09:37,035 --> 02:09:39,037 PRODUCTS, THEY SHOULD BE ABLE TO 3530 02:09:39,104 --> 02:09:44,409 ACCUMULATE ENOUGH DATA WITH THE 3531 02:09:44,476 --> 02:09:46,545 VTN LABS TO WORK OUT THE SCIENCE 3532 02:09:46,612 --> 02:09:49,314 BEHIND THE DESIGN OF NEW PRIMING 3533 02:09:49,381 --> 02:09:53,719 AND BOOSTING IMMUNOGENS. 3534 02:09:53,785 --> 02:09:56,255 THE NIAID, THE DIVISION OF AIDS, 3535 02:09:56,321 --> 02:09:58,457 WE DID NOT ESSENTIALLY FUND 3536 02:09:58,524 --> 02:10:00,192 PRODUCT DEVELOPMENT. 3537 02:10:00,259 --> 02:10:02,728 WE FUND THE DEVELOPMENT OF THE 3538 02:10:02,794 --> 02:10:05,597 SCIENCE THAT ENABLES PRODUCT 3539 02:10:05,664 --> 02:10:11,236 DEVELOPMENT. 3540 02:10:11,303 --> 02:10:15,707 >> ARE THERE OTHER QUESTIONS? 3541 02:10:15,774 --> 02:10:15,908 OKAY. 3542 02:10:15,974 --> 02:10:22,281 THANK YOU FOR THAT. 3543 02:10:22,347 --> 02:10:24,149 PLEASE, EVERYBODY, PUT IN YOUR 3544 02:10:24,216 --> 02:10:28,487 VOTE. 3545 02:10:28,554 --> 02:10:29,588 MARTINA, DO YOU WANT TO -- I 3546 02:10:29,655 --> 02:10:31,990 THINK YOU'RE NEXT. 3547 02:10:32,057 --> 02:10:40,999 MARINA, YOU WANT TO COME UP? 3548 02:10:41,066 --> 02:10:42,701 >> GOOD AFTERNOON. 3549 02:10:42,768 --> 02:10:44,770 >> WE CAN'T HEAR YOU VERY WELL. 3550 02:10:44,836 --> 02:10:45,304 MOVE THE MIC. 3551 02:10:45,370 --> 02:10:46,638 >> HELLO? 3552 02:10:46,705 --> 02:10:48,373 NO? 3553 02:10:48,440 --> 02:10:49,441 OH. 3554 02:10:49,508 --> 02:10:50,075 GOOD AFTERNOON. 3555 02:10:50,142 --> 02:10:51,944 MY NAME IS MARINA PROTOPOPOVA. 3556 02:10:52,010 --> 02:10:56,748 I AM A PROGRAM OFFICER AND HERE 3557 02:10:56,815 --> 02:10:58,584 TO PRESENT THE CONCEPT FOR A NEW 3558 02:10:58,650 --> 02:10:59,451 INITIATIVE, ADVANCING 3559 02:10:59,518 --> 02:11:00,752 TRANSLATION OF LONG-ACTING 3560 02:11:00,819 --> 02:11:02,554 STRATEGIES FOR HIV AND 3561 02:11:02,621 --> 02:11:03,555 HIV-ASSOCIATED COINFORECASTS. 3562 02:11:03,622 --> 02:11:05,857 IN SHORT, AT LAST. 3563 02:11:05,924 --> 02:11:09,127 THIS CONCEPT WAS DEVELOPED BY 3564 02:11:09,194 --> 02:11:11,563 TWO PROGRAMS, THERAPEUTICS 3565 02:11:11,630 --> 02:11:12,998 RESEARCH PROGRAM AND PREVENTION 3566 02:11:13,065 --> 02:11:15,000 SCIENCES PROGRAM, AND I'M HERE 3567 02:11:15,067 --> 02:11:17,636 ON BEHALF OF A GROUP PROGRAM 3568 02:11:17,703 --> 02:11:18,937 OFFICERS WHO ARE WORKING TO 3569 02:11:19,004 --> 02:11:21,907 DEVELOP THIS INITIATIVE. 3570 02:11:21,974 --> 02:11:28,580 THE MAIN OBJECTIVE OF OUR NEW 3571 02:11:28,647 --> 02:11:29,948 INITIATIVE IS PRODUCT 3572 02:11:30,015 --> 02:11:30,382 DEVELOPMENT. 3573 02:11:30,449 --> 02:11:33,986 WE ACTUALLY -- OBJECTIVE IS TO 3574 02:11:34,052 --> 02:11:35,821 BUT SORT PRE-CLINICAL ACTIVITIES 3575 02:11:35,887 --> 02:11:37,022 FOR DEVELOPMENT OF SAFE AND 3576 02:11:37,089 --> 02:11:39,224 EFFECTIVE LONG-ACTING/SUSTAINED 3577 02:11:39,291 --> 02:11:40,292 RELEASE TECHNOLOGIES FOR 3578 02:11:40,359 --> 02:11:42,160 PREVENTION AND TREATMENT OF HIV 3579 02:11:42,227 --> 02:11:43,862 AND HIV-ASSOCIATED COINFECTIONS, 3580 02:11:43,929 --> 02:11:46,798 AND TO ULTIMATELY PROVIDE 3581 02:11:46,865 --> 02:11:48,033 INFORMATION AND PROVIDE THE DATA 3582 02:11:48,100 --> 02:11:50,902 TO BE INCLUDED INTO SUBMISSION 3583 02:11:50,969 --> 02:11:53,772 OF IND APPLICATION TO THE FDA. 3584 02:11:53,839 --> 02:11:57,009 SO THE MAIN OVERALL GOAL IS 3585 02:11:57,075 --> 02:11:58,810 WE'RE AIMING TO FACILITATE THE 3586 02:11:58,877 --> 02:12:01,813 TRANSLATION OF INNOVATIVE 3587 02:12:01,880 --> 02:12:03,048 TECHNOLOGIES, 3588 02:12:03,115 --> 02:12:03,982 LONG-ACTING/SUSTAINED RELEASE, 3589 02:12:04,049 --> 02:12:05,384 FROM R & D TO IND. 3590 02:12:05,450 --> 02:12:10,122 THIS IS NEW, IT'S RFA GRANT, 3591 02:12:10,188 --> 02:12:13,925 ACTIVITY CODE IT'S R61/R33, NO 3592 02:12:13,992 --> 02:12:15,627 CLINICAL TRIALS, DURATION OF 3593 02:12:15,694 --> 02:12:16,928 AWARD FIVE YEARS, TWO YEARS FOR 3594 02:12:16,995 --> 02:12:18,230 THE FIRST PHASE, THREE YEARS FOR 3595 02:12:18,297 --> 02:12:20,299 THE SECOND. 3596 02:12:20,365 --> 02:12:23,769 FIRST TOTAL COST FOR INITIATIVE 3597 02:12:23,835 --> 02:12:26,138 $4 MILLION, EXPECTING TO FUND 3598 02:12:26,204 --> 02:12:26,872 THREE TO FOUR APPLICATIONS. 3599 02:12:26,938 --> 02:12:30,008 AGAIN, PARTNERS, WE ARE PARTNERS 3600 02:12:30,075 --> 02:12:32,210 ON DEVELOPING THE LONG-ACTING 3601 02:12:32,277 --> 02:12:33,679 SUSTAINED RELEASE THERAPEUTICS, 3602 02:12:33,745 --> 02:12:35,047 THERAPEUTICS RESEARCH PROGRAM 3603 02:12:35,113 --> 02:12:36,481 AND PREVENTION SCIENCES PROGRAM. 3604 02:12:36,548 --> 02:12:40,585 THIS INITIATIVE WILL ADDRESS THE 3605 02:12:40,652 --> 02:12:42,354 PRIORITIES OF O.A.R., OFFICE FOR 3606 02:12:42,421 --> 02:12:44,189 AIDS RESEARCH, DEVELOP NEXT 3607 02:12:44,256 --> 02:12:46,258 GENERATION EFFECTIVE TREATMENTS, 3608 02:12:46,325 --> 02:12:48,427 REDUCE HIV INCIDENCE AND HALT 3609 02:12:48,493 --> 02:12:51,029 THE SPREAD OF HIV INFECTION BY 3610 02:12:51,096 --> 02:12:52,564 DEFINING HIGHLY EFFECTIVE 3611 02:12:52,631 --> 02:12:54,266 PREVENTION STRATEGIES, AND 3612 02:12:54,333 --> 02:13:02,441 ADDRESS HIV COMORBIDITIES AND, 3613 02:13:02,507 --> 02:13:05,711 INFECTIONS AND COMPLICATIONS. 3614 02:13:05,777 --> 02:13:07,779 THIS IS A RAPIDLY DEVELOPING 3615 02:13:07,846 --> 02:13:09,081 FIELD, AND BECAUSE DEVELOPMENT 3616 02:13:09,147 --> 02:13:10,282 OF -- BECAUSE SAFE, EFFECTIVE 3617 02:13:10,349 --> 02:13:12,451 AND ACCEPTABLE STRATEGIES WILL 3618 02:13:12,517 --> 02:13:14,519 SIMPLIFY DOSING REQUIREMENTS AND 3619 02:13:14,586 --> 02:13:16,288 POTENTIALLY LEAD TO IMPROVED 3620 02:13:16,355 --> 02:13:17,823 ADHERENCE AND REDUCE EMERGENCE 3621 02:13:17,889 --> 02:13:20,125 OF DRUG RESISTANCE. 3622 02:13:20,192 --> 02:13:22,294 BECAUSE IN HIV, WE LOOK AT THAT 3623 02:13:22,361 --> 02:13:25,530 HERE AND STILL VARIES BETWEEN 3624 02:13:25,597 --> 02:13:27,966 27% TO 80 ACROSS DIFFERENT 3625 02:13:28,033 --> 02:13:29,501 POPULATIONS IN VARIOUS STUDIES. 3626 02:13:29,568 --> 02:13:33,538 IN HIV AND TB, WE'RE LOOKING AT 3627 02:13:33,605 --> 02:13:36,775 THE LONG -- UP TO 24 MONTHS 3628 02:13:36,842 --> 02:13:40,045 TREATMENT REGIMEN FOR 3629 02:13:40,112 --> 02:13:40,946 TUBERCULOSIS, ADHERENCE IS 3630 02:13:41,012 --> 02:13:43,882 CRITICAL, ESPECIALLY FOR DRUG 3631 02:13:43,949 --> 02:13:47,686 RESISTANT -- IN HBV WITH 3632 02:13:47,753 --> 02:13:48,253 LONG-ACTING ANTIRETROVIRALS 3633 02:13:48,320 --> 02:13:50,422 MOVING IN THE CLINIC, THE 3634 02:13:50,489 --> 02:13:51,857 COMPATIBLE -- DEVELOPMENT OF 3635 02:13:51,923 --> 02:13:54,359 COMPATIBLE LO LONG-ACTING 3636 02:13:54,426 --> 02:13:55,794 TREATMENTS FOR HBV WILL BE 3637 02:13:55,861 --> 02:13:57,095 REQUIRED, AND GLOBALLY, WE'RE 3638 02:13:57,162 --> 02:14:00,132 LOOKING AT HIV AND HCV, AND THIS 3639 02:14:00,198 --> 02:14:01,933 WOULD BE A VERY IMPORTANT 3640 02:14:02,000 --> 02:14:04,536 SOLUTION TO THE PROBLEM IF WE 3641 02:14:04,603 --> 02:14:08,340 CAN DETECT AND TREAT THE HCV, 3642 02:14:08,407 --> 02:14:10,275 AND THIS IS WHY THE DEVELOPMENT 3643 02:14:10,342 --> 02:14:11,910 OF LONG-ACTING FORMULATION TO BE 3644 02:14:11,977 --> 02:14:13,879 USED AS A SINGLE DOSE 3645 02:14:13,945 --> 02:14:18,250 ALTERNATIVE WILL HELP EY ELIMINE 3646 02:14:18,316 --> 02:14:18,784 HCV. 3647 02:14:18,850 --> 02:14:20,285 UNDERSTANDING THE CRITICAL NEED 3648 02:14:20,352 --> 02:14:22,587 AND PROMISE POTENTIAL AND THE 3649 02:14:22,654 --> 02:14:24,723 CHALLENGES, THE DIVISION HAD 3650 02:14:24,790 --> 02:14:26,825 SEVERAL INITIATIVES AND IT HAS 3651 02:14:26,892 --> 02:14:29,127 PUT ENORMOUS RESOURCES TO 3652 02:14:29,194 --> 02:14:30,529 DEVELOP THIS FIELD FORWARD, TO 3653 02:14:30,595 --> 02:14:34,366 MOVE THIS FIELD FORWARD AND 3654 02:14:34,433 --> 02:14:38,770 DEVELOP PROMISING TECHNOLOGIES. 3655 02:14:38,837 --> 02:14:44,609 OUIN BOTH PROGRAMS -- HAS VERY 3656 02:14:44,676 --> 02:14:47,245 PROMISING INTERESTING 3657 02:14:47,312 --> 02:14:51,516 TECHNOLOGIES THAT ALREADY SHOWED 3658 02:14:51,583 --> 02:14:52,818 HIGH POTENTIAL. 3659 02:14:52,884 --> 02:14:56,354 SO WE HAVE TWO TECHNOLOGIES ALL 3660 02:14:56,421 --> 02:14:57,289 RIGHT ALREADY IN CLINICAL TRIALS 3661 02:14:57,355 --> 02:14:59,758 AND THEY WERE DEVELOPED WITH OUR 3662 02:14:59,825 --> 02:15:00,292 FUNDING. 3663 02:15:00,358 --> 02:15:06,631 WE HAVE THE TECHNOLOGY IN -- 3664 02:15:06,698 --> 02:15:08,033 THEY JUST MARK DIFFERENT COLORS 3665 02:15:08,099 --> 02:15:11,269 SO WE'RE LOOKING AT THE 3666 02:15:11,336 --> 02:15:14,239 TECHNOLOGIES ARE IN BLUE. 3667 02:15:14,306 --> 02:15:18,810 THEY ARE ENTER IND DEVELOPMENT 3668 02:15:18,877 --> 02:15:22,080 OR JUST ABOUT TO ENTER, AND IN 3669 02:15:22,147 --> 02:15:23,281 GREEN, THIS IS JUST EXAMPLES OF 3670 02:15:23,348 --> 02:15:26,318 THE TECHNOLOGY THAT ARE OUT 3671 02:15:26,384 --> 02:15:30,722 THERE THAT THEY ALREADY HAVE 3672 02:15:30,789 --> 02:15:33,091 POTENTIAL TO TREAT OR PREVENT 3673 02:15:33,158 --> 02:15:39,064 HIV AND GETTING NOW EVEN TB AND 3674 02:15:39,130 --> 02:15:44,469 HPV, THAT THHBV, PROBABLY IN A , 3675 02:15:44,536 --> 02:15:47,005 THEY WILL BE ENTERING THE 3676 02:15:47,072 --> 02:15:48,106 PRE-IND DEVELOPMENT STUDIES. 3677 02:15:48,173 --> 02:15:52,210 WITH THAT, WHILE WE CELEBRATE 3678 02:15:52,277 --> 02:15:54,846 THE SUCCESSES OF OUR FUNDING AND 3679 02:15:54,913 --> 02:15:58,116 OUR INVESTIGATORS, WE ALSO 3680 02:15:58,183 --> 02:16:01,753 UNDERSTAND THAT THERE IS -- THEY 3681 02:16:01,820 --> 02:16:03,088 ARE GETTING INTO THE SO-CALLED 3682 02:16:03,154 --> 02:16:05,924 VALLEY OF DEATH IN DRUG 3683 02:16:05,991 --> 02:16:09,561 DEVELOPMENT, WHERE ACTUALLY 3684 02:16:09,628 --> 02:16:11,530 GETTING THROUGH -- THROUGH IND 3685 02:16:11,596 --> 02:16:14,866 DEVELOPMENT, IND DIRECT 3686 02:16:14,933 --> 02:16:16,568 PRE-CLINICAL STUDIES, FILING IND 3687 02:16:16,635 --> 02:16:19,938 IN EARLY PHASE ONE AND CLINICAL 3688 02:16:20,005 --> 02:16:24,743 TRIALS, WILL REQUIRE FUNDING 3689 02:16:24,809 --> 02:16:26,611 PARTNERSHIPS, EXPERTISE, SO FOR 3690 02:16:26,678 --> 02:16:28,079 US AS A FUNDING AGENCY, IT'S 3691 02:16:28,146 --> 02:16:31,483 VERY IMPORTANT TO HELP 3692 02:16:31,550 --> 02:16:33,451 INVESTIGATE, TO AID 3693 02:16:33,518 --> 02:16:34,319 INVESTIGATORS TO SUCCEED GOING 3694 02:16:34,386 --> 02:16:37,923 THROUGH THE VALLEY OF DEATH AND 3695 02:16:37,989 --> 02:16:39,891 FOR US IS VERY IMPORTANT TO 3696 02:16:39,958 --> 02:16:42,193 ADVANCE PROMISE IN TECHNOLOGY 3697 02:16:42,260 --> 02:16:42,994 TOWARDS CLINICAL TRIALS. 3698 02:16:43,061 --> 02:16:47,766 SO IT'S CRITICAL, IDENTIFY GAPS, 3699 02:16:47,832 --> 02:16:49,868 REMOVE THE ROADBLOCKS AND 3700 02:16:49,935 --> 02:16:50,635 PROVIDE TIMELY FUNDING TO 3701 02:16:50,702 --> 02:16:52,470 SUPPORT THE RESOURCES. 3702 02:16:52,537 --> 02:16:54,005 AND WE BELIEVE THAT OUR PROPOSED 3703 02:16:54,072 --> 02:16:55,874 NEW CONCEPT, NEW INITIATIVE, 3704 02:16:55,941 --> 02:16:58,410 WILL FILL THIS GAP, THAT WILL 3705 02:16:58,476 --> 02:17:00,879 PROVIDE THE FUNDING TO ENABLE 3706 02:17:00,946 --> 02:17:02,414 PRE-CLINICAL PRODUCT 3707 02:17:02,480 --> 02:17:05,216 DEVELOPMENT, PRE-IND STUDIES, 3708 02:17:05,283 --> 02:17:06,084 IND-DIRECTED PRE-CLINICAL 3709 02:17:06,151 --> 02:17:09,154 DEVELOPMENT. 3710 02:17:09,220 --> 02:17:11,389 THE SCOPE. 3711 02:17:11,456 --> 02:17:15,927 SCOPE OF THIS INITIATIVE IS -- 3712 02:17:15,994 --> 02:17:17,128 LOOKING AT THE FUNDING 3713 02:17:17,195 --> 02:17:19,297 PRE-CLINICAL RESEARCH TO MEET 3714 02:17:19,364 --> 02:17:20,298 PRE-CLINICAL RESEARCH 3715 02:17:20,365 --> 02:17:22,500 REQUIREMENTS, SO WE'RE LOOKING 3716 02:17:22,567 --> 02:17:24,336 AT MOSTLY THE TWO SECTIONS OF 3717 02:17:24,402 --> 02:17:24,869 IND. 3718 02:17:24,936 --> 02:17:27,706 SO IT'S ANIMAL TOX PHARMACOLOGY 3719 02:17:27,772 --> 02:17:30,442 AND THE CHEMISTRY MANUFACTURING 3720 02:17:30,508 --> 02:17:32,611 AND CONTROL. 3721 02:17:32,677 --> 02:17:34,012 SO THE SCOPE MAY INCLUDE BUT NOT 3722 02:17:34,079 --> 02:17:36,014 LIMITED TO IND-DIRECTED 3723 02:17:36,081 --> 02:17:36,881 PHARMACOLOGY AND TOXICOLOGY 3724 02:17:36,948 --> 02:17:38,316 STUDIES TO ADDRESS REGULATORY 3725 02:17:38,383 --> 02:17:40,218 REQUIREMENTS FOR CLINICAL 3726 02:17:40,285 --> 02:17:41,086 SAFETY, TOXICOLOGY AND DRUG 3727 02:17:41,152 --> 02:17:44,322 DOSING PARAMETERS. 3728 02:17:44,389 --> 02:17:45,657 SPECIALIZED TOXICITY TET 3729 02:17:45,724 --> 02:17:46,758 TESTING. 3730 02:17:46,825 --> 02:17:47,626 ADVANCED IN VIVO EFFICACY 3731 02:17:47,692 --> 02:17:49,327 STUDIES IN APPROPRIATE MODELS TO 3732 02:17:49,394 --> 02:17:50,729 CONFIRM OR ESTABLISH EFFICACIOUS 3733 02:17:50,795 --> 02:17:52,063 DOSE, WHICH WILL BE VERY 3734 02:17:52,130 --> 02:17:56,301 IMPORTANT HERE, ES PESH LI ESPEN 3735 02:17:56,368 --> 02:17:57,802 LIEU OF CONDUCTING THE 3736 02:17:57,869 --> 02:17:58,903 TOXICOLOGY STUDIES AND 3737 02:17:58,970 --> 02:18:00,005 DETERMINING WHAT IS THE SAFE 3738 02:18:00,071 --> 02:18:00,739 DOSE. 3739 02:18:00,805 --> 02:18:02,507 PROCESS DEVELOPMENT AND 3740 02:18:02,574 --> 02:18:04,576 ANALYTICAL DEVELOPMENT SCALEUP 3741 02:18:04,643 --> 02:18:06,177 PRODUCTION, GMP MANUFACTURING, 3742 02:18:06,244 --> 02:18:08,480 STABILITY TESTING BASED ON FDA 3743 02:18:08,546 --> 02:18:10,649 GUIDANCE, REGULATORY ACTIVITY, 3744 02:18:10,715 --> 02:18:12,951 INCLUDING PREIND MEETINGS, AND 3745 02:18:13,018 --> 02:18:15,420 WE ALSO PURPOSELY INCLUDED -- WE 3746 02:18:15,487 --> 02:18:16,955 SAW IT WAS VERY IMPORTANT TO 3747 02:18:17,022 --> 02:18:18,189 INCLUDE HERE, NON-CLINICAL 3748 02:18:18,256 --> 02:18:20,792 STUDIES OF CLINICAL STAGE 3749 02:18:20,859 --> 02:18:21,960 PRODUCTS, BECAUSE GETTING FROM 3750 02:18:22,027 --> 02:18:23,261 PHASE ONE TO PHASE TWO AND 3751 02:18:23,328 --> 02:18:27,499 FURTHER WILL REQUIRE SPECIALIZED 3752 02:18:27,565 --> 02:18:38,043 TOXICOLOGY TOXICITY TESTING, 3753 02:18:40,912 --> 02:18:41,446 CARCINOGENICITY. 3754 02:18:41,513 --> 02:18:42,681 SO OUT OF SCOPE, IT WILL BE 3755 02:18:42,747 --> 02:18:43,682 CLINICAL TRIALS AND EARLY 3756 02:18:43,748 --> 02:18:46,317 DEVELOPMENTAL WORK, AND WE WILL 3757 02:18:46,384 --> 02:18:48,053 REFER INVESTIGATORS TO A 3758 02:18:48,119 --> 02:18:51,089 DIFFERENT INITIATIVE THAT WE 3759 02:18:51,156 --> 02:18:53,491 HAVE ONGOING IN THE DIVISION. 3760 02:18:53,558 --> 02:18:54,693 ELIGIBILITY. 3761 02:18:54,759 --> 02:18:57,429 BESIDES SMALL BUSINESSES, IT 3762 02:18:57,495 --> 02:19:00,765 WILL OPEN -- THE ACADEMIC 3763 02:19:00,832 --> 02:19:04,502 INVESTIGATORS WILL BE ELIGIBLE 3764 02:19:04,569 --> 02:19:06,337 TO APPLY, FOREIGN INSTITUTIONS, 3765 02:19:06,404 --> 02:19:07,539 AS PART OF THE DEVELOPMENT. 3766 02:19:07,605 --> 02:19:08,740 BUT THERE ARE REQUIREMENTS. 3767 02:19:08,807 --> 02:19:11,009 THE REQUIREMENTS WE WILL BE 3768 02:19:11,076 --> 02:19:12,977 LOOKING AT MATURE ENOUGH 3769 02:19:13,044 --> 02:19:13,678 TECHNOLOGY THAT ALREADY 3770 02:19:13,745 --> 02:19:15,280 DEMONSTRATED THERAPEUTIC EFFECT 3771 02:19:15,346 --> 02:19:17,382 AND APPROPRIATE ANIMAL MODELS 3772 02:19:17,449 --> 02:19:18,850 AND INTERMITTENT DOSING FROM 3773 02:19:18,917 --> 02:19:19,751 EITHER SINGLE ADMINISTRATION OR 3774 02:19:19,818 --> 02:19:23,221 CONTINUOUS DOSING. 3775 02:19:23,288 --> 02:19:24,389 AND IN THE HIV COMMUNITY IT'S 3776 02:19:24,456 --> 02:19:30,261 GOING TO BE A MINIMUM OF ONE ONE 3777 02:19:30,328 --> 02:19:32,397 EVERY THREE MONTHS DOSING AND 3778 02:19:32,464 --> 02:19:35,100 TB, HBV OR HCV, A MINIMUM OF 3779 02:19:35,166 --> 02:19:36,735 ONCE A MONTH DOSING. 3780 02:19:36,801 --> 02:19:38,703 SO PROPOSED STRATEGY HAS 3781 02:19:38,770 --> 02:19:39,270 DEMONSTRATED COMPETITIVE 3782 02:19:39,337 --> 02:19:40,438 ADVANTAGE. 3783 02:19:40,505 --> 02:19:42,173 WHAT WE'RE TALKING ABOUT, WE'RE 3784 02:19:42,240 --> 02:19:45,443 TALKING ABOUT THE DURATION OF 3785 02:19:45,510 --> 02:19:48,947 THOSE IN IMPROVEMENT OF VOLUMES, 3786 02:19:49,013 --> 02:19:52,450 VISIBILITY OF SCALE TORE 3787 02:19:52,517 --> 02:19:54,185 COST-EFFECTIVENESS, THE -- TO 3788 02:19:54,252 --> 02:19:57,922 NAME JUST AS EXAMPLES. 3789 02:19:57,989 --> 02:20:00,725 RESEARCH PLAN MUST INCLUDE 3790 02:20:00,792 --> 02:20:01,493 TARGET PRODUCT PROFILE AND 3791 02:20:01,559 --> 02:20:03,361 ADDRESS ALL IND COMPONENTS, 3792 02:20:03,428 --> 02:20:06,798 WHILE WE SAY IT WILL FUND A 3793 02:20:06,865 --> 02:20:07,699 MAJORITY OF THE PRE-CLINICAL 3794 02:20:07,766 --> 02:20:09,200 RESEARCH, IT'S TWO SECTIONS, 3795 02:20:09,267 --> 02:20:10,201 HOWEVER, UNDERSTANDING THE WHOLE 3796 02:20:10,268 --> 02:20:11,236 PROGRAM WOULD BE VERY IMPORTANT 3797 02:20:11,302 --> 02:20:14,873 TO ACTUALLY -- TO FORMULATE WHAT 3798 02:20:14,939 --> 02:20:17,842 STUDIES WILL BE NEEDED. 3799 02:20:17,909 --> 02:20:20,612 MILESTONES AND GO/NO-GO 3800 02:20:20,678 --> 02:20:22,313 DECISIONS WITH THE TIMELINE ARE 3801 02:20:22,380 --> 02:20:24,682 VERY -- WILL BE REQUIRED. 3802 02:20:24,749 --> 02:20:30,088 AND ADDRESS IPIS P ISSUES TO ENE 3803 02:20:30,155 --> 02:20:31,456 FREEDOM TO OPERATE AND DATA 3804 02:20:31,523 --> 02:20:32,590 SHARING, AND THE PRODUCT 3805 02:20:32,657 --> 02:20:34,993 DEVELOPMENT ITSELF REQUIRES 3806 02:20:35,059 --> 02:20:36,327 MULTIDISCIPLINARY EXPERTISE. 3807 02:20:36,394 --> 02:20:39,230 SO IT REQUIRES PEOPLE FROM 3808 02:20:39,297 --> 02:20:41,299 COMING TOGETHER IN PARTNERSHIP 3809 02:20:41,366 --> 02:20:42,066 BE COLLABORATIONS. 3810 02:20:42,133 --> 02:20:43,735 SO WE UNDERSTAND THAT 3811 02:20:43,802 --> 02:20:46,504 PARTICIPATION OF CROs ONE WAY 3812 02:20:46,571 --> 02:20:49,073 OR ANOTHER WILL BE -- WE 3813 02:20:49,140 --> 02:20:50,675 ANTICIPATE IT WILL BE NEEDED, SO 3814 02:20:50,742 --> 02:20:53,778 WE WILL REQUIRE INDUSTRY OR 3815 02:20:53,845 --> 02:20:59,317 TRANSLATIONAL PARTNER OR ADVI 3816 02:20:59,384 --> 02:20:59,551 ADVISOR. 3817 02:20:59,617 --> 02:21:00,952 WE ACTUALLY KNOW THIS BECAUSE OF 3818 02:21:01,019 --> 02:21:01,619 TRANSLATIONAL RESEARCH. 3819 02:21:01,686 --> 02:21:02,854 ALSO PART OF THE REQUIREMENT 3820 02:21:02,921 --> 02:21:05,623 WILL BE EXPERT ADVISORY BOARD OF 3821 02:21:05,690 --> 02:21:08,693 INDEPENDENT EXPERTS IN RELEVANT 3822 02:21:08,760 --> 02:21:12,797 AREAS FORMED SOON AFTERWARDS TO 3823 02:21:12,864 --> 02:21:13,598 GUIDE AND HELP THE INVESTIGATOR 3824 02:21:13,665 --> 02:21:18,503 AND THE TEAM IN THE ACTIVITIES. 3825 02:21:18,570 --> 02:21:19,470 MECHANISM. 3826 02:21:19,537 --> 02:21:29,180 IT WILL USE BIPHASIC R61/R33. 3827 02:21:29,247 --> 02:21:31,282 FIRST PHASE IS FOR TWO YEARS TO 3828 02:21:31,349 --> 02:21:33,818 OBTAIN CRITICAL RESEARCH TO 3829 02:21:33,885 --> 02:21:36,154 FURTHER DEMONSTRATE THE 3830 02:21:36,221 --> 02:21:38,223 FEASIBILITY AND COMPETITIVE 3831 02:21:38,289 --> 02:21:42,060 ADVANTAGE, AND R33 PHRASE WILL 3832 02:21:42,126 --> 02:21:43,394 ENABLE PRE-CLINICAL DEVELOPMENT 3833 02:21:43,461 --> 02:21:44,829 BEFORE IND SUBMISSION. 3834 02:21:44,896 --> 02:21:46,464 SO MILESTONES WILL BE REQUIRED 3835 02:21:46,531 --> 02:21:49,868 FOR BOTH PHASES, AND TO 3836 02:21:49,934 --> 02:21:51,803 FACILITATE CLINICAL TRANSLATION, 3837 02:21:51,870 --> 02:21:53,838 WE WILL REQUIRE A PLAN FOR 3838 02:21:53,905 --> 02:21:57,242 PRE-IND MEETING AND SUBMITTING 3839 02:21:57,308 --> 02:21:58,309 PRE-IND PACKAGE TO THE FDA. 3840 02:21:58,376 --> 02:21:59,344 TRANSITION MILESTONES FROM ONE 3841 02:21:59,410 --> 02:22:01,813 PHASE TO ANOTHER IS ALSO 3842 02:22:01,880 --> 02:22:03,548 CRITICAL HERE, BECAUSE THEY WILL 3843 02:22:03,615 --> 02:22:06,818 DEFINE SUCCESS DURING THE FIRST 3844 02:22:06,885 --> 02:22:08,586 PHASE AND CONSIDERATION FOR 3845 02:22:08,653 --> 02:22:10,521 FURTHER FUNDING AND WILL BE 3846 02:22:10,588 --> 02:22:12,924 NEGOTIATED WITH NIH STAFF. 3847 02:22:12,991 --> 02:22:14,125 WITH THE TRANSITION OF HOW IT'S 3848 02:22:14,192 --> 02:22:14,792 GOING TO LOOK. 3849 02:22:14,859 --> 02:22:21,766 SO BEFORE THE END OF R61, THE 3850 02:22:21,833 --> 02:22:24,269 AWARDEES SUBMIT THE TRANSITION 3851 02:22:24,335 --> 02:22:26,004 PACKAGE TO SAY THIS IS THE 3852 02:22:26,070 --> 02:22:29,173 PROGRESS -- OUR PROGRESS O UNDER 3853 02:22:29,240 --> 02:22:31,175 THE GRANT AND DESCRIBE THE 3854 02:22:31,242 --> 02:22:32,777 ADVANCEMENT TOWARDS THOSE 3855 02:22:32,844 --> 02:22:35,546 NEGOTIATED MILESTONES. 3856 02:22:35,613 --> 02:22:37,916 AND THE DISCONTINUATION OF R33. 3857 02:22:37,982 --> 02:22:38,950 WE UNDERSTAND THAT WE'RE LOOKING 3858 02:22:39,017 --> 02:22:41,719 AT THE RESEARCH, AND IT'S KIND 3859 02:22:41,786 --> 02:22:48,426 OF -- IT CAN BE SOMEWHAT 3860 02:22:48,493 --> 02:22:49,427 CIRCUMSTANCES AND THOSE 3861 02:22:49,494 --> 02:22:51,496 MILESTONES MAY BE REVISED, NOT 3862 02:22:51,562 --> 02:22:52,897 LARGELY BUT SOME MODIFIED AND 3863 02:22:52,964 --> 02:22:55,600 WILL BE NEGOTIATED WITH THE NIH 3864 02:22:55,667 --> 02:22:59,470 TO DETERMINE ELIGIBILITY FOR THE 3865 02:22:59,537 --> 02:23:02,674 AWARD PRIOR TO R33 AWARD. 3866 02:23:02,740 --> 02:23:04,976 SO R33 FUNDING DECISION WILL BE 3867 02:23:05,043 --> 02:23:06,711 BASED ON SUCCESSFUL COMPLETION 3868 02:23:06,778 --> 02:23:08,012 OF TRANSITION MILESTONES, 3869 02:23:08,079 --> 02:23:10,014 DEMONSTRATE ITS STRONG POTENTIAL 3870 02:23:10,081 --> 02:23:12,717 FOR TRANSLATION TO CLINICAL 3871 02:23:12,784 --> 02:23:13,985 TRIALS, PROGRAMMATIC PRIORITIES 3872 02:23:14,052 --> 02:23:19,257 AND AVAILABILITY OF FUNDS. 3873 02:23:19,324 --> 02:23:23,494 SO AGAIN, WE WERE -- THIS SLIDE 3874 02:23:23,561 --> 02:23:24,395 DEMONSTRATES WHERE WE ARE IN 3875 02:23:24,462 --> 02:23:27,098 TERMS OF OUR INITIATIVE AND 3876 02:23:27,165 --> 02:23:29,968 RESOURCES, AND THIS PARTICULAR 3877 02:23:30,034 --> 02:23:34,205 NEW INITIATIVE AT LAST WILL FEEL 3878 02:23:34,272 --> 02:23:37,375 MUCH NOTICEABLE TO OVERCOME 3879 02:23:37,442 --> 02:23:40,211 TRANSLATIONAL GAP IN WHAT WE 3880 02:23:40,278 --> 02:23:40,645 CURRENTLY HAVE. 3881 02:23:40,712 --> 02:23:44,782 THE SO IT WILL ALSO -- IT'S VERY 3882 02:23:44,849 --> 02:23:46,317 COHESIVE WITH ALL THE 3883 02:23:46,384 --> 02:23:47,285 INITIATIVES AND RESOURCES THAT 3884 02:23:47,352 --> 02:23:50,054 WE CURRENTLY HAVE. 3885 02:23:50,121 --> 02:23:51,789 TO ADVANCE INNOVATIVE TECHNOLOGY 3886 02:23:51,856 --> 02:23:55,493 AND TO IND AND CLINICAL TRIALS. 3887 02:23:55,560 --> 02:23:58,563 SO IN ADDITION TO JUST GOING 3888 02:23:58,629 --> 02:24:05,970 THROUGH, SO -- IT'S R01, IT'S 3889 02:24:06,037 --> 02:24:07,138 HYPOTHESIS DRIVEN MECHANISM. 3890 02:24:07,205 --> 02:24:10,808 WE ALSO HAVE SUSTAINED RELEASE 3891 02:24:10,875 --> 02:24:11,776 TREATMENT OR PREVENTION, AND 3892 02:24:11,843 --> 02:24:19,083 THIS INITIATIVE HAD BEEN -- BEEN 3893 02:24:19,150 --> 02:24:22,820 REISSUED SEVERAL TIMES, MORE 3894 02:24:22,887 --> 02:24:24,122 THAN 10 YEARS, BEEN QUITE 3895 02:24:24,188 --> 02:24:24,789 SUCCESSFUL. 3896 02:24:24,856 --> 02:24:28,793 LAST YEAR WE PUT FORWARD AND 3897 02:24:28,860 --> 02:24:30,328 IT'S ALREADY SHOWN INTEREST IN A 3898 02:24:30,395 --> 02:24:32,163 PLANNING STRATEGY GRANT, SO WE 3899 02:24:32,230 --> 02:24:34,065 ACTUALLY CONNECT THE 3900 02:24:34,132 --> 02:24:37,468 PRE-CLINICAL PROGRAM WITH THE 3901 02:24:37,535 --> 02:24:38,703 CLINICAL TRIALS. 3902 02:24:38,770 --> 02:24:41,105 SO THE ACTUAL LAYOUT, THE 3903 02:24:41,172 --> 02:24:44,242 PRE-IND STRATEGY TO ALLOW -- SO 3904 02:24:44,308 --> 02:24:50,114 WE ARE MOVING FROM OUR -- TO THE 3905 02:24:50,181 --> 02:24:50,948 CLINICAL TRIALS WITH THIS 3906 02:24:51,015 --> 02:24:51,716 PLANNING STRATEGY. 3907 02:24:51,783 --> 02:24:53,785 I DIDN'T MENTION, BUT THE 3908 02:24:53,851 --> 02:24:59,424 SUSTAINED RELEASE TREATMENT FOR 3909 02:24:59,490 --> 02:25:01,092 STRAT-T, WE FOCUS ONLY ON 3910 02:25:01,159 --> 02:25:01,793 INNOVATIVE TECHNOLOGY. 3911 02:25:01,859 --> 02:25:05,363 THIS IS WHERE THE EARLY 3912 02:25:05,430 --> 02:25:07,432 DEVELOPMENT, THE WORK. 3913 02:25:07,498 --> 02:25:14,806 THE CLINICAL TRIAL, THE GLOBAL 3914 02:25:14,872 --> 02:25:17,909 CLINICAL NETWORKS A AND, AGAIN, 3915 02:25:17,975 --> 02:25:20,411 WILL ALLOW THE TRANSLATION FROM 3916 02:25:20,478 --> 02:25:22,580 R ARND D TO IND IN THE CLINICAL 3917 02:25:22,647 --> 02:25:26,384 TRIALS TO LABEL THIS. 3918 02:25:26,451 --> 02:25:27,819 AS SBIR OPPORTUNITIES ARE STILL 3919 02:25:27,885 --> 02:25:29,587 THERE BUT IT'S OPEN FOR SMALL 3920 02:25:29,654 --> 02:25:29,887 BUSINESSES. 3921 02:25:29,954 --> 02:25:33,257 WE ALSO HAVE RESOURCES, VERY 3922 02:25:33,324 --> 02:25:35,126 VALUABLE. 3923 02:25:35,193 --> 02:25:38,896 IT'S A -- PROGRAM IN EXISTENCE 3924 02:25:38,963 --> 02:25:42,533 FOR THE LAST 10 YEARS AND HELPED 3925 02:25:42,600 --> 02:25:44,502 TREMENDOUSLY TO MOVE THE FIELD 3926 02:25:44,569 --> 02:25:44,735 FORWARD. 3927 02:25:44,802 --> 02:25:46,504 IT'S A RESEARCH PROGRAM THAT 3928 02:25:46,571 --> 02:25:47,705 RECEIVES BROAD BASED SCIENTIFIC 3929 02:25:47,772 --> 02:25:48,773 SUPPORT TO INVESTIGATORS WHO ARE 3930 02:25:48,840 --> 02:25:51,409 WORKING IN THAT FIELD, AND IT'S 3931 02:25:51,476 --> 02:25:57,515 VERY SUCCESSFUL, MANY WORKSHOPS, 3932 02:25:57,582 --> 02:26:00,151 PUBLICATIONS THERE ARE FANTASTIC 3933 02:26:00,218 --> 02:26:02,019 ABILITIES, THE WEBSITE, ANY 3934 02:26:02,086 --> 02:26:02,587 INVESTIGATOR WORKING IN THE 3935 02:26:02,653 --> 02:26:04,789 FIELD CAN SEE, THEY CAN TRACK 3936 02:26:04,856 --> 02:26:07,825 THE PRE-CLINICAL, CLINICAL, 3937 02:26:07,892 --> 02:26:11,496 REGULATORY MITIGATIONS FOR THE 3938 02:26:11,562 --> 02:26:17,735 HIV AND THE HIV COINFECTION, IN 3939 02:26:17,802 --> 02:26:19,937 MODEL SERVICED, SO IT'S A GREAT 3940 02:26:20,004 --> 02:26:22,206 RESOURCE BUT LAST BUT NOT LEAST 3941 02:26:22,273 --> 02:26:30,314 IT'S THE CLINICAL CONTRACT 3942 02:26:30,381 --> 02:26:33,384 SERVICES PROGRAM, TO HELP FIELD 3943 02:26:33,451 --> 02:26:37,822 INVESTIGATORS, OUR CONTRACTORS 3944 02:26:37,889 --> 02:26:39,724 DOING THE SERVICES, AND THIS IS 3945 02:26:39,790 --> 02:26:48,833 VERY VALUABLE RESOURCE. 3946 02:26:48,900 --> 02:26:51,135 SO THE TWO REVIEWERS WERE -- OF 3947 02:26:51,202 --> 02:26:52,737 THIS CONCEPT, IT'S DR. KEITH 3948 02:26:52,803 --> 02:26:56,574 JEROME AND RICHARD D'AQUILA. 3949 02:26:56,641 --> 02:26:58,643 I WOULD LIKE TO TAKE THIS 3950 02:26:58,709 --> 02:27:01,379 OPPORTUNITY TO THANK THEM AGAIN 3951 02:27:01,445 --> 02:27:02,280 FOR THEIR FEEDBACK, QUESTIONS 3952 02:27:02,346 --> 02:27:02,980 AND DISCUSSIONS. 3953 02:27:03,047 --> 02:27:06,017 IT WAS A GREAT DISCUSSION WE HAD 3954 02:27:06,083 --> 02:27:07,652 AND THEIR FEEDBACK WAS VERY, 3955 02:27:07,718 --> 02:27:09,086 VERY IMPORTANT TO US, AND 3956 02:27:09,153 --> 02:27:12,390 ENCOURAGING. 3957 02:27:12,456 --> 02:27:14,725 BOTH REVIEWERS WERE 3958 02:27:14,792 --> 02:27:15,660 ENTHUSIASTICALLY SUPPORTIVE OF 3959 02:27:15,726 --> 02:27:18,396 THIS CONCEPT, AND COMMENTED THAT 3960 02:27:18,462 --> 02:27:20,264 THIS INITIATIVE WILL HAVE 3961 02:27:20,331 --> 02:27:22,433 SUBSTANTIAL IMPACT ON THE FIELD, 3962 02:27:22,500 --> 02:27:24,101 AND TECHNOLOGICALLY WITHIN 3963 02:27:24,168 --> 02:27:26,003 REACH, GIVEN THE CURRENT 3964 02:27:26,070 --> 02:27:27,605 PIPELINE. 3965 02:27:27,672 --> 02:27:29,373 IT ESSENTIAL CHALLENGE ACTUALLY 3966 02:27:29,440 --> 02:27:30,808 MOVING EARLY STAGE RESEARCH 3967 02:27:30,875 --> 02:27:32,109 THROUGH SO CALLED VALLEY OF 3968 02:27:32,176 --> 02:27:35,713 DEATH AND OUR PROGRAM, THE 3969 02:27:35,780 --> 02:27:36,948 INITIATIVE WILL ADDRESS THIS 3970 02:27:37,014 --> 02:27:39,650 NEED IN A POWERFUL WAY, AND 3971 02:27:39,717 --> 02:27:40,985 ALMOST SURELY LEAD TO NEW 3972 02:27:41,052 --> 02:27:43,154 VALUABLE THERAPEUTICS, WHICH IS 3973 02:27:43,221 --> 02:27:45,756 VERY ENCOURAGING, THANK YOU. 3974 02:27:45,823 --> 02:27:48,960 AND ALSO IT'S A PLUS THAT AT 3975 02:27:49,026 --> 02:27:52,330 LAST IS BEING DIRECTED TO 3976 02:27:52,396 --> 02:27:53,864 ACADEMIC INNOVATORS AND EARLY 3977 02:27:53,931 --> 02:27:58,803 STAGE COMMERCIAL ENTITIES, 3978 02:27:58,869 --> 02:27:59,971 PARTICULARLY REMOVING POTENTIAL 3979 02:28:00,037 --> 02:28:01,239 ROADBLOCK FOR SOME ACADEMIC 3980 02:28:01,305 --> 02:28:01,706 GROUPS. 3981 02:28:01,772 --> 02:28:04,575 AND WE HAVE SOME VERY EXCITING 3982 02:28:04,642 --> 02:28:07,011 DEVELOPMENTS AND VERY 3983 02:28:07,078 --> 02:28:08,312 INTERESTING TECHNOLOGY AND GREAT 3984 02:28:08,379 --> 02:28:10,615 PROMISE FROM ACADEMIC 3985 02:28:10,681 --> 02:28:14,385 INSTITUTIONS AS WELL, AND THE 3986 02:28:14,452 --> 02:28:16,153 FACT THAT THIS MECHANISM ALLOWS 3987 02:28:16,220 --> 02:28:20,825 SOME FLEXIBILITY IN NEGOTIATING 3988 02:28:20,891 --> 02:28:24,095 R33 MILESTONE TO ALLOW TO FOCUS 3989 02:28:24,161 --> 02:28:25,463 ON THE END GOALS. 3990 02:28:25,529 --> 02:28:26,764 SUGGESTION WAS MADE THAT TO 3991 02:28:26,831 --> 02:28:29,066 INCLUDE THE LINKS TO ALL OUR 3992 02:28:29,133 --> 02:28:31,569 PROGRAMS THAT THEY FUND 3993 02:28:31,636 --> 02:28:33,871 OPPORTUNITY AND RESOURCES TO 3994 02:28:33,938 --> 02:28:38,609 HELP IN EVENTUAL RFA, TO HELP 3995 02:28:38,676 --> 02:28:39,877 INVESTIGATORS TO LEARN ABOUT ALL 3996 02:28:39,944 --> 02:28:40,378 THAT IS AVAILABLE. 3997 02:28:40,444 --> 02:28:44,348 AND THIS IS THE -- OUR AT LAST 3998 02:28:44,415 --> 02:28:45,316 INITIATIVE, AND WE'LL BE HAPPY 3999 02:28:45,383 --> 02:28:46,250 TO ANSWER QUESTIONS. 4000 02:28:46,317 --> 02:28:51,822 THANK YOU. 4001 02:28:51,889 --> 02:28:53,958 >> THANK YOU VERY MUCH. 4002 02:28:54,025 --> 02:28:54,158 OKAY. 4003 02:28:54,225 --> 02:28:54,892 LET START ONLINE. 4004 02:28:54,959 --> 02:29:03,501 ANY QUESTIONS THERE? 4005 02:29:03,567 --> 02:29:11,976 HOW ABOUT IN THE ROOM? 4006 02:29:12,043 --> 02:29:13,377 WE'LL PROBABLY NEED SOME 4007 02:29:13,444 --> 02:29:14,812 AFTERNOON DRINKS BEFORE WE START 4008 02:29:14,879 --> 02:29:16,514 GETTING MORE QUESTIONS. 4009 02:29:16,580 --> 02:29:17,148 RAPHI, GO AHEAD. 4010 02:29:17,214 --> 02:29:17,915 >> THANKS. 4011 02:29:17,982 --> 02:29:19,417 JUST TWO QUICK QUESTIONS. 4012 02:29:19,483 --> 02:29:24,689 IS THE INTENT THAT THERE WOULD 4013 02:29:24,755 --> 02:29:25,790 BE ONE AWARD FOR THIS? 4014 02:29:25,856 --> 02:29:28,392 IT DOESN'T SAY ON THE SLIDE, AND 4015 02:29:28,459 --> 02:29:32,196 I APOLOGIZE IF I MISSED -- 4016 02:29:32,263 --> 02:29:32,563 >> I APOLOGIZE. 4017 02:29:32,630 --> 02:29:34,365 WE ARE LOOKING AT THE POTENTIAL 4018 02:29:34,432 --> 02:29:37,802 OF UP TO FOUR AWARDS HERE. 4019 02:29:37,868 --> 02:29:39,036 I REMOVED BY MISTAKE. 4020 02:29:39,103 --> 02:29:39,470 I'M SO SORRY. 4021 02:29:39,537 --> 02:29:40,638 >> NO WORRIES. 4022 02:29:40,705 --> 02:29:42,073 AND THEN MY OTHER QUESTION WAS, 4023 02:29:42,139 --> 02:29:44,942 HAVE THERE BEEN BACK CHANNEL 4024 02:29:45,009 --> 02:29:47,044 DISCUSSIONS WITHIN THE INSTITUTE 4025 02:29:47,111 --> 02:29:51,949 ABOUT THE REGULATORY SUPPORT 4026 02:29:52,016 --> 02:29:54,885 THAT THE INSTITUTES ARE WILLING 4027 02:29:54,952 --> 02:29:59,357 TO PROVIDE TO SUCCESSFUL 4028 02:29:59,423 --> 02:30:00,658 GRANTEES OF THIS NEW MECHANISM? 4029 02:30:00,725 --> 02:30:01,992 BECAUSE IT JUST STRIKES ME THAT 4030 02:30:02,059 --> 02:30:04,995 THE COMPLEXITY OF NEW DRUG 4031 02:30:05,062 --> 02:30:06,831 DEVELOPMENT HAS ENORMOUS 4032 02:30:06,897 --> 02:30:08,833 REGULATORY COMPLICATIONS, AND DO 4033 02:30:08,899 --> 02:30:11,669 THE INSTITUTES HAVE EITHER 4034 02:30:11,736 --> 02:30:13,003 CONSULTANTS OR IS THERE IN-HOUSE 4035 02:30:13,070 --> 02:30:15,506 EXPERIENCE THAT CAN HELP 4036 02:30:15,573 --> 02:30:18,008 INVESTIGATORS NAVIGATE THIS 4037 02:30:18,075 --> 02:30:19,009 TOWARDS AN EYE -- HEADING 4038 02:30:19,076 --> 02:30:20,845 TOWARDS THE CLINICAL TRIALS THAT 4039 02:30:20,911 --> 02:30:22,513 WOULD BE FUNDED THROUGH OTHER 4040 02:30:22,580 --> 02:30:23,514 MECHANISMS? 4041 02:30:23,581 --> 02:30:28,486 >> THANKS FOR THE QUESTION. 4042 02:30:28,552 --> 02:30:31,455 IN OUR CONTRACTS, FOR EXAMPLE, 4043 02:30:31,522 --> 02:30:32,757 THE THERAPEUTIC RESEARCH PROGRAM 4044 02:30:32,823 --> 02:30:34,158 AND BASIC SCIENCES PROGRAM, WE 4045 02:30:34,225 --> 02:30:35,626 DON'T HAVE REGULATORY GUIDANCE, 4046 02:30:35,693 --> 02:30:37,161 PER SE, BUT WE DO HAVE OUR 4047 02:30:37,228 --> 02:30:38,963 CONTRACTORS THAT IN PARTICULAR 4048 02:30:39,029 --> 02:30:41,165 FIELDS, THEY CAN PROVIDE 4049 02:30:41,232 --> 02:30:43,401 REGULATORY -- WHAT IS REQUIRED 4050 02:30:43,467 --> 02:30:48,506 FOR, LET'S SAY, SAFETY 4051 02:30:48,572 --> 02:30:51,275 PHARMACOLOGY OR C & C. 4052 02:30:51,342 --> 02:30:52,910 PRETTY SURE THAT PREVENTION 4053 02:30:52,977 --> 02:30:55,780 SCIENCES PROGRAM MIGHT OFFER 4054 02:30:55,846 --> 02:30:58,482 REGULATORY SUPPORT SERVICES. 4055 02:30:58,549 --> 02:31:01,719 BULL WHAT IS IMPORTANT HERE, AND 4056 02:31:01,786 --> 02:31:04,121 W --BUT WHAT IS IMPORTANT HERE,T 4057 02:31:04,188 --> 02:31:05,489 WE ARE LOOKING AT IN THIS 4058 02:31:05,556 --> 02:31:10,694 PARTICULAR INITIATIVE, WE 4059 02:31:10,761 --> 02:31:16,066 HAVE OUR -- LIKE A PAR HERE THAT 4060 02:31:16,133 --> 02:31:17,968 24 PLANNING FOR PRODUCT DEVELOPT 4061 02:31:18,035 --> 02:31:20,571 STRATEGY, THIS IS ACTUALLY -- IT 4062 02:31:20,638 --> 02:31:23,741 WOULD BE A GREAT OPPORTUNITY FOR 4063 02:31:23,808 --> 02:31:28,345 INVESTIGATORS AND TO SIT A 4064 02:31:28,412 --> 02:31:32,817 SPECIFIC WAY WHILE REGULATORY 4065 02:31:32,883 --> 02:31:34,819 CONSULTANTS, OR A PART OF THE 4066 02:31:34,885 --> 02:31:36,320 TEAM, ARE VERY IMPORTANT. 4067 02:31:36,387 --> 02:31:43,127 SO THAT IS HAVING DESIGN THE 4068 02:31:43,194 --> 02:31:44,161 STRATEGIES TO ACTUALLY PROPOSE 4069 02:31:44,228 --> 02:31:47,698 WHAT IS NEEDED FOR THIS RFA AND 4070 02:31:47,765 --> 02:31:51,735 ACTUALLY WE DO -- AS ONE OF OUR 4071 02:31:51,802 --> 02:31:55,506 SCOPES HERE, IN THE SCOPE IS ONE 4072 02:31:55,573 --> 02:31:57,041 OF THE REGULATORY ACTIVITIES 4073 02:31:57,107 --> 02:31:58,442 INCLUDING PREIND MEETINGS WITH 4074 02:31:58,509 --> 02:31:59,009 THE FDA. 4075 02:31:59,076 --> 02:32:01,879 SO WE DO ANTICIPATE THAT THERE 4076 02:32:01,946 --> 02:32:03,747 WOULD BE REGULATORY CONSULTANT 4077 02:32:03,814 --> 02:32:07,985 OR IN ANY -- OR IT CAN BE THE 4078 02:32:08,052 --> 02:32:13,190 OFFICE OR A CONSULTANT, ONE THAT 4079 02:32:13,257 --> 02:32:15,226 PROVIDES REGULATORY -- AS A PART 4080 02:32:15,292 --> 02:32:15,659 OF THE TEAM. 4081 02:32:15,726 --> 02:32:20,898 I HOPE I ANSWERED YOUR QUESTION. 4082 02:32:20,965 --> 02:32:22,366 >> THANKS, IT'S PROBABLY JUST 4083 02:32:22,433 --> 02:32:25,002 WORTH SOME THOUGHT ABOUT THE 4084 02:32:25,069 --> 02:32:27,304 WORDING IN THE RFA ABOUT THAT 4085 02:32:27,371 --> 02:32:27,771 COMPONENT. 4086 02:32:27,838 --> 02:32:28,706 >> OKAY. 4087 02:32:28,772 --> 02:32:33,277 THANK YOU. 4088 02:32:33,344 --> 02:32:35,012 >> I DON'T SEE ANY ADDITIONAL 4089 02:32:35,079 --> 02:32:37,348 QUESTIONS. 4090 02:32:37,414 --> 02:32:40,384 THANK YOU VERY MUCH. 4091 02:32:40,451 --> 02:32:43,053 EVERYBODY PLEASE ENTER YOUR 4092 02:32:43,120 --> 02:32:45,923 VOTE, AND I'LL INTRODUCE KEITH 4093 02:32:45,990 --> 02:32:48,559 CRAWFORD, WHO'S GOING TO PRESENT 4094 02:32:48,626 --> 02:32:55,366 THE LAST CONCEPT. 4095 02:32:55,432 --> 02:32:58,035 OF THE DAY. 4096 02:32:58,102 --> 02:32:59,603 >> SO I'M THE PERSON STANDING 4097 02:32:59,670 --> 02:33:01,505 BETWEEN YOU AND HAPPY HOUR, SO 4098 02:33:01,572 --> 02:33:04,742 I'M GOING TO GET RIGHT INTO IT. 4099 02:33:04,808 --> 02:33:05,209 I'M KEITH CRAWFORD. 4100 02:33:05,276 --> 02:33:06,844 I'M A PROGRAM OFFICER IN THE 4101 02:33:06,911 --> 02:33:07,878 THERAPEUTICS RESEARCH PROGRAM, 4102 02:33:07,945 --> 02:33:10,447 AND I'M GOING TO PRESENT ON THE 4103 02:33:10,514 --> 02:33:12,750 VIROLOGY QUALITY ASSURANCE 4104 02:33:12,816 --> 02:33:13,083 PROGRAM. 4105 02:33:13,150 --> 02:33:14,285 AND THE OBJECTIVE OF THIS 4106 02:33:14,351 --> 02:33:16,120 PROGRAM IS TO PROVIDE 4107 02:33:16,186 --> 02:33:17,755 COMPREHENSIVE QUALITY ASSESSMENT 4108 02:33:17,821 --> 02:33:20,057 PROGRAM FOR THE DAIDS 4109 02:33:20,124 --> 02:33:23,561 LABORATORIES THAT PROVIDE 4110 02:33:23,627 --> 02:33:25,195 VIROLOGIC ASSAYS PRIMARILY FOR 4111 02:33:25,262 --> 02:33:28,465 HIV BUT OTHER VIRAL PATHOGENS IN 4112 02:33:28,532 --> 02:33:30,234 SUPPORTING THE DAIDS CLINICAL 4113 02:33:30,301 --> 02:33:30,968 RESEARCH PROGRAM. 4114 02:33:31,035 --> 02:33:33,604 THIS IS A REISSUE OF A CONTRACT. 4115 02:33:33,671 --> 02:33:36,173 IT'S A 7-YEAR CONTRACT AND THERE 4116 02:33:36,240 --> 02:33:40,077 WILL BE ONE AWARD. 4117 02:33:40,144 --> 02:33:45,883 SO DAIDS HAS AN ARAIL ARRAY OF Y 4118 02:33:45,950 --> 02:33:46,884 ASSURANCE PROGRAMS, SO IN 4119 02:33:46,951 --> 02:33:49,587 ADDITION TO THE VQA, WE HAVE THE 4120 02:33:49,653 --> 02:33:51,121 CPQA OR THE CLINICAL 4121 02:33:51,188 --> 02:33:52,656 PHARMACOLOGY QUALITY ASSURANCE 4122 02:33:52,723 --> 02:33:55,492 PROGRAM, WE HAVE THE IQA, THE 4123 02:33:55,559 --> 02:33:56,594 IMMUNOLOGY QUALITY ASSURANCE 4124 02:33:56,660 --> 02:33:56,827 PROGRAM. 4125 02:33:56,894 --> 02:33:59,930 WE HAVE THE TBQA, QUALITY 4126 02:33:59,997 --> 02:34:03,867 ASAWRASSURANCE PROGRAM THAT SUPS 4127 02:34:03,934 --> 02:34:04,635 TUBERCULOSIS RESEARCH, AND WE 4128 02:34:04,702 --> 02:34:06,070 HAVE A HOST OF OTHERS. 4129 02:34:06,136 --> 02:34:07,471 AND THESE ARE, YOU MIGHT SAY, 4130 02:34:07,538 --> 02:34:09,540 THE FRONT LINE OF OUR QUALITY 4131 02:34:09,607 --> 02:34:11,609 ASSURANCE PROGRAMS. 4132 02:34:11,675 --> 02:34:13,277 THE VIROLOGY QUALITY ASSURANCE 4133 02:34:13,344 --> 02:34:18,849 PROGRAM GOES ALL THE WAY BACK TO 4134 02:34:18,916 --> 02:34:19,049 1988. 4135 02:34:19,116 --> 02:34:22,519 RUSH UNIVERSITY HELD THE PRIOR 4136 02:34:22,586 --> 02:34:24,088 CONTRACT FOR OVER TWO DECADES, 4137 02:34:24,154 --> 02:34:28,225 AND THE CURRENT CONTRACT IS HELD 4138 02:34:28,292 --> 02:34:29,326 BY DUKE UNIVERSITY. 4139 02:34:29,393 --> 02:34:32,796 WE HAVE OVER 100 LABS THAT 4140 02:34:32,863 --> 02:34:35,599 PARTICIPATE IN THE V/Q A PROGRAM 4141 02:34:35,666 --> 02:34:38,736 ACROSS 30 COUNTRIES. 4142 02:34:38,802 --> 02:34:40,070 SO AGAIN, THE OVERVIEW. 4143 02:34:40,137 --> 02:34:41,705 PROVIDING QUALITY ASSURANCE AND 4144 02:34:41,772 --> 02:34:44,775 PROFICIENCY TESTING FOR 4145 02:34:44,842 --> 02:34:47,044 VIROLOGIC-BASED ASSAYS FOR HIV, 4146 02:34:47,111 --> 02:34:47,978 BUT ALSO OTHER PATHOGENS. 4147 02:34:48,045 --> 02:34:51,682 SO WE HAVE DONE PROFICIENCY 4148 02:34:51,749 --> 02:34:54,752 TESTING FOR HEPATITIS C RNA IN 4149 02:34:54,818 --> 02:34:56,587 THE PAST, AND WE ALSO DID SOME 4150 02:34:56,654 --> 02:34:59,890 VERY EARLY WORK WITH COVID-19 IN 4151 02:34:59,957 --> 02:35:01,725 DEVELOPING NEUTRALIZING ASSAYS 4152 02:35:01,792 --> 02:35:04,361 OR EXPLORING DIFFERENT 4153 02:35:04,428 --> 02:35:07,331 NEUTRALIZING ASSAYS. 4154 02:35:07,398 --> 02:35:08,866 IT'S KEY TO POINT OUT THAT THIS 4155 02:35:08,932 --> 02:35:13,370 PROGRAM IS ISO-ACCREDITED, WHICH 4156 02:35:13,437 --> 02:35:15,005 MEANS IT MEETS THE HIGHEST 4157 02:35:15,072 --> 02:35:16,073 STANDARD FOR EFFICIENCY TESTING 4158 02:35:16,140 --> 02:35:17,107 PROVIDERS. 4159 02:35:17,174 --> 02:35:18,075 IT IMPLEMENTS STANDARDS NOT JUST 4160 02:35:18,142 --> 02:35:20,678 FOR EXISTING ASSAYS, BUT IS ALSO 4161 02:35:20,744 --> 02:35:23,047 LOOKING AT THE EVOLUTION OF NEW 4162 02:35:23,113 --> 02:35:24,782 TECHNOLOGIES AND NEW PLATFORMS 4163 02:35:24,848 --> 02:35:28,152 FOR VIROLOGIC ASSAYS. 4164 02:35:28,218 --> 02:35:29,987 THE SUPPORT ASSAY VALIDATION 4165 02:35:30,054 --> 02:35:31,121 FROM THESE LABS, AND THEY ASSIST 4166 02:35:31,188 --> 02:35:33,657 THE LABS IN OPTIMIZING THEIR 4167 02:35:33,724 --> 02:35:36,493 ASSAYS. 4168 02:35:36,560 --> 02:35:37,995 AND THIS POINT I THINK IS REALLY 4169 02:35:38,062 --> 02:35:41,331 IMPORTANT, ENSURING THE VALIDITY 4170 02:35:41,398 --> 02:35:44,601 OF INTER- AND INTRA-LABORATORY 4171 02:35:44,668 --> 02:35:46,136 COMPARABILITY OF THE VIROLOGIC 4172 02:35:46,203 --> 02:35:46,570 LABORATORY DATA. 4173 02:35:46,637 --> 02:35:51,942 THIS IS REALLY KEY BECAUSE 4174 02:35:52,009 --> 02:35:52,509 MULTICENTER CLINICAL TRIALS 4175 02:35:52,576 --> 02:35:56,013 WHERE WE CAN TAKE DAY TA FROM 4176 02:35:56,080 --> 02:35:58,982 LABS ALL AROUND THE WORLD 4177 02:35:59,049 --> 02:36:00,284 BECAUSE WE KNOW THAT THOSE LABS 4178 02:36:00,350 --> 02:36:03,120 ARE PERFORMING THE ASSAYS AT THE 4179 02:36:03,187 --> 02:36:08,292 BEST QUALITY. 4180 02:36:08,358 --> 02:36:10,994 SO THE VQA HAS THREE PRIMARY 4181 02:36:11,061 --> 02:36:12,196 OPERATIONS. 4182 02:36:12,262 --> 02:36:15,933 WE HAVE THE QUANTITATIVE HIV RNA 4183 02:36:15,999 --> 02:36:18,836 OR VIRAL LOAD PROGRAM, WE HAVE 4184 02:36:18,902 --> 02:36:20,537 THE QUALITATIVE HIV NUCLEIC ACID 4185 02:36:20,604 --> 02:36:23,674 TESTING PROGRAM, AND WE HAVE THE 4186 02:36:23,741 --> 02:36:24,908 HIV DRUG RESISTANCE AND 4187 02:36:24,975 --> 02:36:25,976 SEQUENCING PROGRAM. 4188 02:36:26,043 --> 02:36:27,611 SO I'LL JUST TAKE A QUICK LOOK 4189 02:36:27,678 --> 02:36:29,379 AT THESE THREE PROGRAMS AND HOW 4190 02:36:29,446 --> 02:36:31,115 THEY WORK. 4191 02:36:31,181 --> 02:36:33,717 OF COURSE THE QUANTITATIVE IS 4192 02:36:33,784 --> 02:36:35,185 GOING TO ASSESS THE LAB'S 4193 02:36:35,252 --> 02:36:36,920 ABILITY TO DO VIRAL LOAD 4194 02:36:36,987 --> 02:36:38,155 TESTING. 4195 02:36:38,222 --> 02:36:40,324 THESE PT PANELS CAN BE PREPARED 4196 02:36:40,390 --> 02:36:43,627 IN PLASMA OR DRY BLOODSPOTS. 4197 02:36:43,694 --> 02:36:46,263 WE ALSO CAN PREPARE THEM IN CSF 4198 02:36:46,330 --> 02:36:48,232 AND MAY HAVE THE ABILITY TO 4199 02:36:48,298 --> 02:36:52,069 DEVELOP THEM AND OTHER MATRICES 4200 02:36:52,136 --> 02:36:53,303 SUCH AS BREAST MILK, FOR 4201 02:36:53,370 --> 02:36:54,037 EXAMPLE. 4202 02:36:54,104 --> 02:36:57,241 THE PANEL CONSISTS OF A RANGE OF 4203 02:36:57,307 --> 02:36:59,309 DIFFERENT CONCENTRATIONS OF 4204 02:36:59,376 --> 02:37:02,146 VIRAL RNA RANGING FROM VERY HIGH 4205 02:37:02,212 --> 02:37:03,981 CONCENTRATIONS TO CONCENTRATIONS 4206 02:37:04,047 --> 02:37:06,216 CLOSE TO THE LIMIT OF DETECTION 4207 02:37:06,283 --> 02:37:07,751 OF THE ASSAY. 4208 02:37:07,818 --> 02:37:09,286 THERE ARE A NUMBER OF 4209 02:37:09,353 --> 02:37:10,521 REPLICATES, SO THESE ARE 4210 02:37:10,587 --> 02:37:14,958 INTERSPERSED THROUGHOUT THE 4211 02:37:15,025 --> 02:37:16,827 PANEL IN A MANNER THAT IS 4212 02:37:16,894 --> 02:37:18,028 RANDOMIZED BUT IT'S BLINDED, OF 4213 02:37:18,095 --> 02:37:20,664 COURSE, TO THE LABS, AND THEY 4214 02:37:20,731 --> 02:37:23,634 HAVE TO CORRECTLY DETERMINE THE 4215 02:37:23,700 --> 02:37:28,572 CONCENTRATIONS IN THE PANEL. 4216 02:37:28,639 --> 02:37:30,841 THE QUALITATIVE NUCLEIC ACID 4217 02:37:30,908 --> 02:37:32,643 TESTING PROGRAM, AGAIN, THIS IS 4218 02:37:32,709 --> 02:37:36,480 TO DETECT TOTAL VIRAL NUCLEIC 4219 02:37:36,547 --> 02:37:38,348 ACIDS IN CLINICAL SAMPLES. 4220 02:37:38,415 --> 02:37:39,750 THIS PANEL IS PERFORMED 4221 02:37:39,817 --> 02:37:40,050 DIFFERENTLY. 4222 02:37:40,117 --> 02:37:42,519 SO WE TAKE A U1 CELL LINE THAT 4223 02:37:42,586 --> 02:37:47,124 HAS A KNOWN NUMBER OF COPIES OF 4224 02:37:47,191 --> 02:37:50,294 PROVIRAL DNA AND ANNE, AND THOSE 4225 02:37:50,360 --> 02:37:52,262 CELLS ARE DILUTED INTO 4226 02:37:52,329 --> 02:37:54,832 UNINFECTED PPMCs. 4227 02:37:54,898 --> 02:38:00,771 SO WE GENERATE A RANGE OF 4228 02:38:00,838 --> 02:38:01,738 CONCENTRATIONS OF THE DILUTED 4229 02:38:01,805 --> 02:38:04,241 CELLS, AND GERNTION THIS IS A 4230 02:38:04,308 --> 02:38:05,275 QUALITATIVE ASSAY, SO WE WANT TO 4231 02:38:05,342 --> 02:38:06,577 KNOW IS THE SAMPLE REACTIVE OR 4232 02:38:06,643 --> 02:38:10,480 IS IT NON-REACTIVE? 4233 02:38:10,547 --> 02:38:13,317 THIS IS PREPARED IN EITHER WHOLE 4234 02:38:13,383 --> 02:38:18,188 BLOOD OR DRIED BLOODSPOTS, AND 4235 02:38:18,255 --> 02:38:19,389 GLOBALLY WE HAVE 18 LABS THAT 4236 02:38:19,456 --> 02:38:20,057 ARE PARTICIPATING. 4237 02:38:20,123 --> 02:38:21,692 THE LABS ARE GOING TO GET TWO OF 4238 02:38:21,758 --> 02:38:22,860 THESE PANELS EACH YEAR. 4239 02:38:22,926 --> 02:38:25,028 AND THEN WE HAVE THE HIV DRUG 4240 02:38:25,095 --> 02:38:26,763 RESISTANCE OR SEQUENCING 4241 02:38:26,830 --> 02:38:29,066 PROGRAM, AND THE GOAL OF THIS IS 4242 02:38:29,132 --> 02:38:30,934 TO SHOW THE ABILITY OF THE LABS 4243 02:38:31,001 --> 02:38:32,603 TO IDENTIFY THE PRESENCE OF 4244 02:38:32,669 --> 02:38:35,105 MUTATIONS THAT ARE KNOWN TO 4245 02:38:35,172 --> 02:38:37,107 CONFER RESISTANCE TO 4246 02:38:37,174 --> 02:38:41,245 ANTIRETROVIRAL DRUGS. 4247 02:38:41,311 --> 02:38:44,014 MOST OF OUR LABS ARE DOING 4248 02:38:44,081 --> 02:38:45,415 SANGER SEQUENCING BUT WE DO HAVE 4249 02:38:45,482 --> 02:38:46,750 SOME LABS IN INCREASING NUMBERS 4250 02:38:46,817 --> 02:38:48,051 THAT DO NEXT GENERATION 4251 02:38:48,118 --> 02:38:48,719 SEQUENCING. 4252 02:38:48,785 --> 02:38:54,291 AND AGAIN, THE FOCUS IS THE POL 4253 02:38:54,358 --> 02:38:56,393 REGION CONTAINING RT, PR AND IN 4254 02:38:56,460 --> 02:38:56,593 GENES. 4255 02:38:56,660 --> 02:38:57,861 WE HAVE 53 LABS THAT 4256 02:38:57,928 --> 02:39:01,665 PARTICIPATE, INCLUDING SOME W HO 4257 02:39:01,732 --> 02:39:02,566 LABS. 4258 02:39:02,633 --> 02:39:04,067 THEY'RE SURVEILLANCE LABS. 4259 02:39:04,134 --> 02:39:07,871 AND THE LABS ARE GOING TO GET 4260 02:39:07,938 --> 02:39:13,877 TWO OF THESE -- WE HAVE A NUMBER 4261 02:39:13,944 --> 02:39:18,415 OF ISOLATES HERE, STOCK 4262 02:39:18,482 --> 02:39:20,517 CONCENTRATIONS, AND THEY 4263 02:39:20,584 --> 02:39:23,787 REPRESENT VARIOUS DIFFERENT 4264 02:39:23,854 --> 02:39:24,488 VIRAL SUBTYPES, AND YOU CAN SEE 4265 02:39:24,554 --> 02:39:27,524 SOME OF THESE ISOLATES HAVE A 4266 02:39:27,591 --> 02:39:32,229 NUMBER OF RESISTANCE MUTATIONS 4267 02:39:32,296 --> 02:39:33,463 SPANNING THE DIFFERENT TARGET 4268 02:39:33,530 --> 02:39:34,197 GENES. 4269 02:39:34,264 --> 02:39:36,199 SOME HAVE MORE THAN ONE MUTATION 4270 02:39:36,266 --> 02:39:37,634 IN ONE SITE, SOME ONLY HAVE A 4271 02:39:37,701 --> 02:39:41,204 SINGLE MUTATION. 4272 02:39:41,271 --> 02:39:46,944 THE VQA HAS A COLLABORATION WITH 4273 02:39:47,010 --> 02:39:50,981 THE KILL MAN JA KILIMANJARO CHRN 4274 02:39:51,048 --> 02:39:53,050 MEDICAL CENTER IN TANZANIA. 4275 02:39:53,116 --> 02:39:54,351 WE ESTABLISHED THIS 4276 02:39:54,418 --> 02:39:55,018 COLLABORATION SO WE COULD 4277 02:39:55,085 --> 02:39:56,353 PROVIDE MATERIALS THAT REFLECT 4278 02:39:56,420 --> 02:39:58,121 WHAT THE LABS ARE LIKELY TO SEE 4279 02:39:58,188 --> 02:40:01,959 WHEN THEY ENROLL PATIENT INS IN 4280 02:40:02,025 --> 02:40:02,759 THEIR CLINICAL STUDIES. 4281 02:40:02,826 --> 02:40:05,195 SO AS MANY OF YOU KNOW, TANZANIA 4282 02:40:05,262 --> 02:40:07,664 HAS A FAIRLY HIGH PREVALENCE OF 4283 02:40:07,731 --> 02:40:10,200 SUBTYPE A VIRUS, ALSO SUBTYPE D 4284 02:40:10,267 --> 02:40:12,736 VIRUS, AND SOME SUBTYPE C. 4285 02:40:12,803 --> 02:40:14,838 AND HERE'S JUST AN EXAMPLE OF 4286 02:40:14,905 --> 02:40:17,574 SOME OF THE SAMPLES THAT WE 4287 02:40:17,641 --> 02:40:20,477 RECENTLY RECEIVE FROM TANZANIA, 4288 02:40:20,544 --> 02:40:22,846 AND YOU CAN SEE HERE, THE 4289 02:40:22,913 --> 02:40:24,047 SUBTYPE DIVERSITY, ALMOST HALF 4290 02:40:24,114 --> 02:40:26,550 OF THESE ARE SUBTYPE A1, WE HAVE 4291 02:40:26,616 --> 02:40:35,425 A FEW SUBTYPE Cs, AND WE HAVE 4292 02:40:35,492 --> 02:40:38,061 COMMON -- REVERSE TRANSCRIPTASE 4293 02:40:38,128 --> 02:40:41,665 AND INTERGRACE, THESE ARE 4294 02:40:41,732 --> 02:40:42,833 MUTATIONS WE DON'T HAVE 4295 02:40:42,899 --> 02:40:43,867 CURRENTLY REPRESENTED IN OUR 4296 02:40:43,934 --> 02:40:45,035 REPOSITORY. 4297 02:40:45,102 --> 02:40:46,803 WE ALSO HAVE THE ABILITY TO 4298 02:40:46,870 --> 02:40:48,472 ENGINEER INFECTIOUS MOLECULAR 4299 02:40:48,538 --> 02:40:48,705 CLONES. 4300 02:40:48,772 --> 02:40:51,641 SO WE CAN ACTUALLY INTRODUCE 4301 02:40:51,708 --> 02:40:54,945 MUTATIONS INTO ANY OF THESE 4302 02:40:55,012 --> 02:40:58,849 SITES OF THE REVERSE 4303 02:40:58,915 --> 02:41:00,283 TRANSCRIPTASE REGION, THIS IS A 4304 02:41:00,350 --> 02:41:01,918 WAY THAT WE CAN ACTUALLY PUT 4305 02:41:01,985 --> 02:41:03,587 SPECIFIC TYPES OF MUTATIONS IN 4306 02:41:03,653 --> 02:41:06,823 THE MATERIAL THAT GOES INTO THE 4307 02:41:06,890 --> 02:41:08,058 PANELS. 4308 02:41:08,125 --> 02:41:09,726 I WANT TO JUST TAKE A COUPLE 4309 02:41:09,793 --> 02:41:13,397 SLIDES TO DESCRIBE A NEW PILOT 4310 02:41:13,463 --> 02:41:18,568 PROGRAM WHICH IS FOCUSED ON LABS 4311 02:41:18,635 --> 02:41:22,606 THAT DO MEASUREMENTS OF THE 4312 02:41:22,672 --> 02:41:23,173 RESERVOIR. 4313 02:41:23,240 --> 02:41:24,741 THIS IS A COLLABORATION WITH THE 4314 02:41:24,808 --> 02:41:26,476 MARTIN DELANEY COLLABORATIVE, 4315 02:41:26,543 --> 02:41:28,712 AND YOU HEARD MY COLLEAGUES 4316 02:41:28,779 --> 02:41:30,514 DIANE AND TANIA TALK ABOUT THE 4317 02:41:30,580 --> 02:41:32,149 MARTIN DELANEY EARLIER, SO YOU 4318 02:41:32,215 --> 02:41:34,885 KNOW MANY OF THESE LABS ARE 4319 02:41:34,951 --> 02:41:36,386 DOING RESERVOIR ASSAYS. 4320 02:41:36,453 --> 02:41:39,623 MANY OF THEM ARE DOING INTACT 4321 02:41:39,689 --> 02:41:41,658 PROVIRAL DNA ASSAYS. 4322 02:41:41,725 --> 02:41:44,294 BUT THERE ARE VARIATIONS IN HOW 4323 02:41:44,361 --> 02:41:45,896 THEY'RE DOING THESE ASSAYS, SO 4324 02:41:45,962 --> 02:41:47,831 THE QUESTION BECOMES, OKAY, HOW 4325 02:41:47,898 --> 02:41:51,234 DO WE INTERPRET THIS, HOW DO WE 4326 02:41:51,301 --> 02:41:52,636 COMPARE HOW THESE DIFFERENT 4327 02:41:52,702 --> 02:41:54,504 ASSAYS ARE PERFORMING. 4328 02:41:54,571 --> 02:41:56,206 SO ONE OF THE GOALS OF THIS 4329 02:41:56,273 --> 02:41:58,608 PILOT PROGRAM IS TO LOOK AT 4330 02:41:58,675 --> 02:42:01,711 RELATIVE ASSAY PERFORMANCE 4331 02:42:01,778 --> 02:42:03,847 ACROSS THE DIFFERENT LABS, 4332 02:42:03,914 --> 02:42:05,415 BENCHMARKING, LOOKING AT 4333 02:42:05,482 --> 02:42:07,384 INTERLAB REPRODUCIBILITY. 4334 02:42:07,451 --> 02:42:09,586 WE'RE ALSO HOPING TO ESTABLISH 4335 02:42:09,653 --> 02:42:11,188 WHAT ARE THE KEY METRICS THAT 4336 02:42:11,254 --> 02:42:14,458 WE'RE GOING TO USE TO EVALUATE 4337 02:42:14,524 --> 02:42:18,462 PERFORMANCE OF THESE ASSAYS BOTH 4338 02:42:18,528 --> 02:42:19,596 WITHIN AND BETWEEN THE LABS OVER 4339 02:42:19,663 --> 02:42:20,430 TIME. 4340 02:42:20,497 --> 02:42:22,132 SO THE ULTIMATE GOAL IS TO 4341 02:42:22,199 --> 02:42:26,470 DEVELOP A PROFICIENCY TESTING 4342 02:42:26,536 --> 02:42:28,672 PROGRAM THAT WE CAN USE WITH 4343 02:42:28,738 --> 02:42:29,973 LABS THAT ARE DOING PREUR 4344 02:42:30,040 --> 02:42:39,249 CLDOING PURECLINICAL RESEARCH AG 4345 02:42:39,316 --> 02:42:41,084 THE RESERVOIR. 4346 02:42:41,151 --> 02:42:42,686 THE RAVEN COHORT IS A REPOSITORY 4347 02:42:42,752 --> 02:42:44,888 OF PLASMA AND PBMCs THAT ARE 4348 02:42:44,955 --> 02:42:46,556 COLLECTED LONGITUDALLY FROM 4349 02:42:46,623 --> 02:42:49,626 PEOPLE LIVING WITH HIV THAT HAVE 4350 02:42:49,693 --> 02:42:54,631 BOTH SUBTYPE B AND SUBTYPE C 4351 02:42:54,698 --> 02:42:57,634 VIRUS THROUGH A COLLABORATION 4352 02:42:57,701 --> 02:42:59,236 WITH SOUTH AFRICA FOR THE 4353 02:42:59,302 --> 02:42:59,936 SUBTYPE C. 4354 02:43:00,003 --> 02:43:00,770 AND IT'S IMPORTANT TO UNDERSTAND 4355 02:43:00,837 --> 02:43:03,340 THAT THIS MATERIAL IS HIGHLY 4356 02:43:03,406 --> 02:43:04,975 PEDIGREED. 4357 02:43:05,041 --> 02:43:06,743 SO THE SAMPLES IN THIS 4358 02:43:06,810 --> 02:43:09,146 REPOSITORY HAVE BEEN ANALYZED 4359 02:43:09,212 --> 02:43:12,983 BLI QVOA CELL ASSOCIATED RNA, 4360 02:43:13,049 --> 02:43:16,186 INTACT PROVIRAL DNA OF DIFFERENT 4361 02:43:16,253 --> 02:43:19,789 ASSAYS TO MEASURE THE RESERVOIR. 4362 02:43:19,856 --> 02:43:26,897 WE THINK THIS IS IDEAL MATERIAL. 4363 02:43:26,963 --> 02:43:30,300 THIS FOCUSES ON PROVIRAL DNA AND 4364 02:43:30,367 --> 02:43:30,934 ITS VARIATIONS. 4365 02:43:31,001 --> 02:43:32,435 WHAT WOULD THE PANELS LOOK LIKE. 4366 02:43:32,502 --> 02:43:35,805 SO WE WOULD HAVE A PANEL OF 4367 02:43:35,872 --> 02:43:39,042 PBMCs FROM RAVEN REPOSITORY, 4368 02:43:39,109 --> 02:43:39,643 AND THIS WOULD COME FROM 4369 02:43:39,709 --> 02:43:41,645 INDIVIDUALS THAT HAVE BEEN 4370 02:43:41,711 --> 02:43:44,614 CHARACTERIZED TO HAVE A HIGH 4371 02:43:44,681 --> 02:43:47,817 RESERVOIR OR LOW RESERVOIR, THIS 4372 02:43:47,884 --> 02:43:52,088 WOULD ALL BE MIXED INTO A PANEL. 4373 02:43:52,155 --> 02:43:54,491 WE HAVE PGH >> TRUSTEE CROSBIE: 4374 02:43:54,558 --> 02:44:03,967 HAVE AN ANALYTICAL DELUSIONSERID 4375 02:44:04,034 --> 02:44:09,139 SERIAL DELUSIONS OF J-LAT CELLS, 4376 02:44:09,206 --> 02:44:10,974 DILUTED INTO NEGATIVE JURKAT 4377 02:44:11,041 --> 02:44:12,075 CELLS, SO WE HAVE THESE 4378 02:44:12,142 --> 02:44:12,976 DELUSIONS IN THIS PANEL THAT 4379 02:44:13,043 --> 02:44:16,046 HAVE BEEN SENT OUT TO A LAB, 4380 02:44:16,112 --> 02:44:17,814 BEING ANALYZED AS WE SPEAK, AND 4381 02:44:17,881 --> 02:44:20,917 WE SHOULD BE HAVING THE RESULTS 4382 02:44:20,984 --> 02:44:25,855 IN PERHAPS A MONTH. 4383 02:44:25,922 --> 02:44:27,624 EACH SITE WILL PERFORM THEIR 4384 02:44:27,691 --> 02:44:29,359 IPDA ASSAYS, SUBMIT THEIR DATA 4385 02:44:29,426 --> 02:44:31,361 TO THE VQA AND OUR AMAZING 4386 02:44:31,428 --> 02:44:33,430 STATISTICAL TEAM WILL LOOK AT 4387 02:44:33,496 --> 02:44:35,966 THE RESULTS AND TRY TO LOOK AT 4388 02:44:36,032 --> 02:44:37,767 PATTERNS OR SEE WHAT WE CAN 4389 02:44:37,834 --> 02:44:42,839 LEARN FROM THIS PILOT 4390 02:44:42,906 --> 02:44:52,048 INTERVENTION. 4391 02:44:52,115 --> 02:44:53,583 SO WE HAD TWO EXCELLENT 4392 02:44:53,650 --> 02:44:55,885 REVIEWERS FOR THIS PROJECT. 4393 02:44:55,952 --> 02:44:57,454 WE HAD DR. KEITH JEROME AT 4394 02:44:57,520 --> 02:45:01,391 UNIVERSITY OF WASHINGTON. 4395 02:45:01,458 --> 02:45:10,433 WE HAD DR. LISHOMWA NDHLOVU. 4396 02:45:10,500 --> 02:45:13,336 SOME OF THE COMMENTS FOCUSING ON 4397 02:45:13,403 --> 02:45:17,307 CROSS-SUBTYPE IPDAs IN OUR 4398 02:45:17,374 --> 02:45:24,080 PILOT THAT I'VE JUST DESCRIBED, 4399 02:45:24,147 --> 02:45:26,516 PILOTING IPDAs TOWARDS CERTAIN 4400 02:45:26,583 --> 02:45:29,686 TYPES OF VIRUSES. 4401 02:45:29,753 --> 02:45:33,490 THE RAVEN COHORT AS I POINTED 4402 02:45:33,556 --> 02:45:35,992 OUT CONTAINS MATERIAL FROM 4403 02:45:36,059 --> 02:45:37,694 SUBTYPES B AND C SO WE DO HAVE 4404 02:45:37,761 --> 02:45:38,461 MATERIAL FROM DIFFERENT 4405 02:45:38,528 --> 02:45:39,029 SUBTYPES. 4406 02:45:39,095 --> 02:45:40,330 BUT OUR PILOT PROGRAM IS GOING 4407 02:45:40,397 --> 02:45:42,666 TO START OUT FOCUSING ON SUBTYPE 4408 02:45:42,732 --> 02:45:44,734 B, BECAUSE EVERYBODY CAN DO 4409 02:45:44,801 --> 02:45:46,603 THAT, AGAIN, WE DON'T KNOW WHAT 4410 02:45:46,670 --> 02:45:47,937 DIRECTION THIS PILOT IS GOING TO 4411 02:45:48,004 --> 02:45:48,371 GO. 4412 02:45:48,438 --> 02:45:50,707 IT'S A PILOT SO WE'RE GOING TO 4413 02:45:50,774 --> 02:45:53,109 MINIMIZE THE VARIABLES, FOCUS ON 4414 02:45:53,176 --> 02:45:54,210 SUBTYPE B AND THEN WHEN WE SEE 4415 02:45:54,277 --> 02:45:56,513 WHAT TYPE OF RESULTS WE GET, 4416 02:45:56,579 --> 02:45:57,514 HOPEFULLY AT SOME POINT WE WILL 4417 02:45:57,580 --> 02:46:03,320 BE ABLE TO EXPAND AND LOOK AT 4418 02:46:03,386 --> 02:46:04,187 IPDAs THAT EITHER CAN BE USED 4419 02:46:04,254 --> 02:46:06,189 FOR ALL SUBTYPES OR SPECIFIC FOR 4420 02:46:06,256 --> 02:46:11,328 CERTAIN TYPES OF SUBTYPES. 4421 02:46:11,394 --> 02:46:11,928 A QUESTION CAME YOU THE ABOUT 4422 02:46:11,995 --> 02:46:14,297 LABS THAT PARTICIPATE IN V/Q A 4423 02:46:14,364 --> 02:46:17,534 VQA ANDWHAT TYPES OF CHALLENGEST 4424 02:46:17,600 --> 02:46:18,668 THEY HAVE. 4425 02:46:18,735 --> 02:46:20,637 INDEED SOME OF THE LABS DO HAVE 4426 02:46:20,704 --> 02:46:22,339 CHALLENGES IN PARTICIPATING. 4427 02:46:22,405 --> 02:46:24,507 THE VQA STARTS OUT BY VALIDATING 4428 02:46:24,574 --> 02:46:27,143 AND OPTIMIZING THE ASSAYS THAT 4429 02:46:27,210 --> 02:46:29,379 THESE LABS ARE USING. 4430 02:46:29,446 --> 02:46:30,880 THERE ARE A NUMBER OF 4431 02:46:30,947 --> 02:46:31,981 PRELIMINARY ASSESSMENTS THAT 4432 02:46:32,048 --> 02:46:35,051 LABS HAVE TO PARTICIPATE IN 4433 02:46:35,118 --> 02:46:37,320 BEFORE THEY BECOME FULL MEMBERS 4434 02:46:37,387 --> 02:46:39,956 OR PARTICIPANTS IN THE VQA 4435 02:46:40,023 --> 02:46:41,291 PROGRAM. 4436 02:46:41,358 --> 02:46:43,326 WHEN PANELS ARE SENT OUT, IF A 4437 02:46:43,393 --> 02:46:50,166 LAB FAILS A PANEL, THE VQA HELPS 4438 02:46:50,233 --> 02:46:51,768 WITH TROUBLESHOOTING AND MAKES 4439 02:46:51,835 --> 02:46:52,736 RECOMMENDATIONS AND THEY CAN GET 4440 02:46:52,802 --> 02:46:54,337 ANOTHER PANEL TO SEE IF THEY 4441 02:46:54,404 --> 02:46:55,238 CORRECTED THE PROBLEMS. 4442 02:46:55,305 --> 02:46:57,540 BUT IF THERE ARE LABS THAT 4443 02:46:57,607 --> 02:46:59,976 CONSISTENTLY HAVE PERFORMANCE 4444 02:47:00,043 --> 02:47:01,311 ISSUES, THEN THEY WILL HAVE TO 4445 02:47:01,378 --> 02:47:02,412 WITHDRAW FROM THE PROGRAM. 4446 02:47:02,479 --> 02:47:03,113 THE POINT IS RAISED ABOUT 4447 02:47:03,179 --> 02:47:06,449 WHETHER THE APPLICANTS FOR THE 4448 02:47:06,516 --> 02:47:09,686 CONTRACT SHOULD DEMONSTRATE THE 4449 02:47:09,753 --> 02:47:10,553 CAPABILITY FOR CONDUCTING NEW 4450 02:47:10,620 --> 02:47:13,556 VIRAL ASSAYS, SO THIS COULD BE 4451 02:47:13,623 --> 02:47:15,325 FOR EMERGING PATHOGENS, FOR 4452 02:47:15,392 --> 02:47:17,727 EXAMPLE, OR PANDEMIC RESPONSE, 4453 02:47:17,794 --> 02:47:21,064 OR JUST PIVOTING OR OPTIMIZING 4454 02:47:21,131 --> 02:47:24,634 ASSAYS TO HIV OR OTHER VIRUSES. 4455 02:47:24,701 --> 02:47:26,936 WE AGREE THAT THAT IS IMPORTANT. 4456 02:47:27,003 --> 02:47:31,574 THIS IS A KEY EVALUATION 4457 02:47:31,641 --> 02:47:32,442 CRITERIA WHICH WILL BE 4458 02:47:32,509 --> 02:47:35,178 IDENTIFIED IN THE SOLICITATION. 4459 02:47:35,245 --> 02:47:36,379 I WILL STOP THERE AND TAKE ANY 4460 02:47:36,446 --> 02:47:36,679 QUESTIONS. 4461 02:47:36,746 --> 02:47:44,020 THANK YOU FOR YOUR TIME. 4462 02:47:44,087 --> 02:47:44,854 >> THANK YOU VERY MUCH. 4463 02:47:44,921 --> 02:47:50,260 ARE THERE QUESTIONS IN THE ROOM? 4464 02:47:50,326 --> 02:47:50,460 GRACE? 4465 02:47:50,527 --> 02:47:51,227 >> HEY, KEITH. 4466 02:47:51,294 --> 02:47:56,032 LET ME JUST SAY, I LOVE THE VQA. 4467 02:47:56,099 --> 02:47:57,567 I INTERACT WITH THEM A LOT. 4468 02:47:57,634 --> 02:47:59,002 THEY ARE REALLY CRITICAL FOR THE 4469 02:47:59,068 --> 02:48:01,805 CLINICAL TRIALS NETWORK, AND 4470 02:48:01,871 --> 02:48:04,374 I -- FROM THE OLD DAYS WHERE WE 4471 02:48:04,441 --> 02:48:05,208 WENT AROUND TEACHING EVERYBODY 4472 02:48:05,275 --> 02:48:08,378 HOW TO DO QUANTITATIVE HIV RNA 4473 02:48:08,445 --> 02:48:11,114 TO NOW, IT HAS JUST BEEN 4474 02:48:11,181 --> 02:48:12,382 COMPLETELY TRANSFORMATIVE, AND 4475 02:48:12,449 --> 02:48:14,350 THEY CONTINUE TO HELP THE LABS 4476 02:48:14,417 --> 02:48:15,485 WITH THEIR VALIDATIONS, ET 4477 02:48:15,552 --> 02:48:17,821 CETERA. 4478 02:48:17,887 --> 02:48:21,090 HOWEVER, I DO THINK HAVING THE 4479 02:48:21,157 --> 02:48:23,693 VQA CREATE THE PROFICIENCY 4480 02:48:23,760 --> 02:48:25,395 PANELS AS THEY'RE DOING GIVEN 4481 02:48:25,462 --> 02:48:28,064 THAT WHO HAS STANDARDS, THERE'S 4482 02:48:28,131 --> 02:48:29,165 A LOT OF QUALITY PROVIDERS UP 4483 02:48:29,232 --> 02:48:33,036 THERE WHO HAVE STANDARD HIV, 4484 02:48:33,102 --> 02:48:34,737 RNA, DNA PANELS, I'M NOT SURE 4485 02:48:34,804 --> 02:48:38,641 THAT'S THE BEST USE OF THE VQA 4486 02:48:38,708 --> 02:48:38,908 RESOURCES. 4487 02:48:38,975 --> 02:48:39,609 THEY'VE DONE THIS FOREVER. 4488 02:48:39,676 --> 02:48:42,645 THEY WERE THE FIRST PEOPLE TO DO 4489 02:48:42,712 --> 02:48:44,981 THIS. 4490 02:48:45,048 --> 02:48:46,316 BUT I WOULD LIKE NOW TO SEE 4491 02:48:46,382 --> 02:48:47,750 THOSE RESOURCES MORE IN WHAT YOU 4492 02:48:47,817 --> 02:48:49,385 WERE DESCRIBING WITH THE 4493 02:48:49,452 --> 02:48:52,188 RESERVOIRS AND THE IPDA, SO THAT 4494 02:48:52,255 --> 02:48:53,623 THEIR RESOURCES FOR CREATING 4495 02:48:53,690 --> 02:48:56,025 PANELS, OBVIOUSLY I THINK THEY 4496 02:48:56,092 --> 02:48:59,729 SHOULD STILL DISTRIBUTE AND HELP 4497 02:48:59,796 --> 02:49:01,197 THE LABS COULD BE BETTER SPENT 4498 02:49:01,264 --> 02:49:02,732 ON MORE CUTTING EDGE PROGRAMS 4499 02:49:02,799 --> 02:49:04,367 WHERE WE DON'T HAVE QUALITY 4500 02:49:04,434 --> 02:49:07,136 ASSURANCE MATERIALS. 4501 02:49:07,203 --> 02:49:08,505 BUT GREAT PROGRAM. 4502 02:49:08,571 --> 02:49:09,873 >> WELL, THANK YOU VERY MUCH, 4503 02:49:09,939 --> 02:49:12,308 GRACE, AND CERTAINLY YOUR 4504 02:49:12,375 --> 02:49:13,510 GUIDANCE HAS BEEN WELL 4505 02:49:13,576 --> 02:49:14,777 APPRECIATED AND HAS HELPED US 4506 02:49:14,844 --> 02:49:16,813 OVER THE YEARS. 4507 02:49:16,880 --> 02:49:19,015 I THINK WHEN WE START 4508 02:49:19,082 --> 02:49:19,983 CONSIDERING THE QUESTION THAT 4509 02:49:20,049 --> 02:49:23,119 YOU'RE POSING, KEEPING IN MIND 4510 02:49:23,186 --> 02:49:25,388 THAT, AGAIN, THIS IS A GLOBAL 4511 02:49:25,455 --> 02:49:27,790 PROGRAM, SO THERE'S SOME 4512 02:49:27,857 --> 02:49:30,860 COUNTRIES THAT MAY STILL REQUIRE 4513 02:49:30,927 --> 02:49:32,295 SOME OF THE SERVICES THAT WE 4514 02:49:32,362 --> 02:49:33,663 PROVIDE, SO I THINK THAT'S ONE 4515 02:49:33,730 --> 02:49:38,134 WAY THAT WE NEED TO THINK ABOUT 4516 02:49:38,201 --> 02:49:39,235 THIS, BUT I THINK YOU'RE 4517 02:49:39,302 --> 02:49:40,336 ABSOLUTELY RIGHT, AND I THINK 4518 02:49:40,403 --> 02:49:41,271 THAT THE WORK THAT WE'RE DOING 4519 02:49:41,337 --> 02:49:43,306 WITH THE PILOT FOR THE RESERVOIR 4520 02:49:43,373 --> 02:49:48,177 ASSAYS IS AN EXAMPLE OF WHAT THE 4521 02:49:48,244 --> 02:49:49,045 VQA CAN DO. 4522 02:49:49,112 --> 02:49:50,013 THERE HAS BEEN SOME WORK THAT 4523 02:49:50,079 --> 02:49:53,550 THE VQA HAS DONE WITH SOME OF 4524 02:49:53,616 --> 02:49:57,587 THE SINGLE COPY ASSAYS, SO THIS 4525 02:49:57,654 --> 02:49:59,822 IS A DIRECTION THAT WE COULD GO. 4526 02:49:59,889 --> 02:50:01,991 ONE OF THE THINGS I THINK THIS 4527 02:50:02,058 --> 02:50:05,461 REALTHAT'S REALLY EXCITING ABOUR 4528 02:50:05,528 --> 02:50:06,329 QUALITY ASSURANCE PROGRAM IS WE 4529 02:50:06,396 --> 02:50:10,233 CAN PIVOT AND WE CAN FOLLOW THE 4530 02:50:10,300 --> 02:50:11,634 SCIENCE, SO WHEN WE AWARD THESE 4531 02:50:11,701 --> 02:50:14,137 CONTRACTS, WE'RE AWARDING THEM 4532 02:50:14,203 --> 02:50:18,541 TO TEAMS THAT HAVE THE PROPER 4533 02:50:18,608 --> 02:50:20,643 PERSONNEL AND RESOURCES TO GO IN 4534 02:50:20,710 --> 02:50:22,078 WHAT DIRECTION THAT THE SCIENCE 4535 02:50:22,145 --> 02:50:25,415 IS GOING IN. 4536 02:50:25,481 --> 02:50:27,584 SO WE HEAR YOU, AND AGAIN, WE 4537 02:50:27,650 --> 02:50:31,854 HAVE AN ADVISORY BOARD FOR THE 4538 02:50:31,921 --> 02:50:33,489 VQA AS WE DO FOR ALL OF OUR 4539 02:50:33,556 --> 02:50:34,791 PROGRAMS, SO THESE TYPES OF 4540 02:50:34,857 --> 02:50:35,992 SUGGESTIONS CAN BE MADE, AND WE 4541 02:50:36,059 --> 02:50:40,263 CAN FOLLOW THE SCIENCE. 4542 02:50:40,330 --> 02:50:41,464 THANK YOU FOR THAT QUESTION. 4543 02:50:41,531 --> 02:50:44,067 >> CINDY, I SEE YOUR HAND UP. 4544 02:50:44,133 --> 02:50:48,538 >> YEAH, SO THAT WAS A NICE 4545 02:50:48,605 --> 02:50:48,871 PRESENTATION. 4546 02:50:48,938 --> 02:50:50,840 I DO NOT DO THIS ASSAY, SO I 4547 02:50:50,907 --> 02:50:53,076 JUST WAS CURIOUS, YOU KNOW, WHAT 4548 02:50:53,142 --> 02:50:55,745 IS THE EXPERIMENTAL VARIATION 4549 02:50:55,812 --> 02:51:00,350 ACROSS LABS AND HOW DO YOU 4550 02:51:00,416 --> 02:51:04,787 DEFINE FAILURE? 4551 02:51:04,854 --> 02:51:06,556 HOW MUCH VARIATION IS THERE IN 4552 02:51:06,623 --> 02:51:07,690 THIS ASSAY THAT'S CONSIDERED 4553 02:51:07,757 --> 02:51:07,991 ACCEPTABLE? 4554 02:51:08,057 --> 02:51:09,025 >> RIGHT, SO THAT'S A GOOD 4555 02:51:09,092 --> 02:51:10,560 POINT, AND THAT'S GOING TO 4556 02:51:10,627 --> 02:51:12,695 DEPEND, EACH OF THESE ASSAYS 4557 02:51:12,762 --> 02:51:15,098 IS -- IT'S GOING TO VARY, BUT 4558 02:51:15,164 --> 02:51:16,633 THAT IS SOMETHING THAT IS 4559 02:51:16,699 --> 02:51:19,369 TRACKED VERY CAREFULLY BY OUR 4560 02:51:19,435 --> 02:51:25,208 STATISTICAL TEAM, SO EVERY TIME 4561 02:51:25,274 --> 02:51:26,609 WE SEND OUT A PANEL, ALL OF THE 4562 02:51:26,676 --> 02:51:28,144 DATA IS COLLECTED, ALL OF THE 4563 02:51:28,211 --> 02:51:29,278 PERFORMANCE IS TRACKED SO WE CAN 4564 02:51:29,345 --> 02:51:30,580 SEE IF LABS ARE PERFORMING 4565 02:51:30,647 --> 02:51:33,416 WITHIN WHAT IS THE ACCEPTABLE 4566 02:51:33,483 --> 02:51:37,520 RANGE FOR THAT PARTICULAR ASSAY, 4567 02:51:37,587 --> 02:51:38,521 SO ALL OF THAT IS TRACKED. 4568 02:51:38,588 --> 02:51:42,458 AND IF LABS GO OUTSIDE OF THAT, 4569 02:51:42,525 --> 02:51:43,926 THEN THEY MAY HAVE TO REPEAT THE 4570 02:51:43,993 --> 02:51:47,330 ASSAY OR MAY HAVE TO TWEAK HOW 4571 02:51:47,397 --> 02:51:49,932 THEIR ASSAY IS DOING OR DO SOME 4572 02:51:49,999 --> 02:51:50,767 PROBLEM SHOOTING, BUT THAT IS 4573 02:51:50,833 --> 02:51:52,869 SOMETHING THAT IS REGULATED VERY 4574 02:51:52,935 --> 02:51:53,436 CLOSELY. 4575 02:51:53,503 --> 02:51:55,038 AND AS I ALSO OVERSEE SOME OF 4576 02:51:55,104 --> 02:52:00,543 THESE OTH OTHER QUALITY ASSURANE 4577 02:52:00,610 --> 02:52:01,444 PROGRAMS, THE MECHANISM IS THE 4578 02:52:01,511 --> 02:52:01,744 SAME. 4579 02:52:01,811 --> 02:52:03,680 SO WE HAVE VERY SOLID 4580 02:52:03,746 --> 02:52:04,647 STATISTICAL SUPPORT TO MAKE SURE 4581 02:52:04,714 --> 02:52:06,616 THAT THE ASSAYS PERFORM WITHIN A 4582 02:52:06,683 --> 02:52:07,450 CERTAIN LIMIT. 4583 02:52:07,517 --> 02:52:08,451 I HOPE THAT ANSWERS YOUR 4584 02:52:08,518 --> 02:52:11,421 QUESTION. 4585 02:52:11,487 --> 02:52:15,658 >> ANY ADDITIONAL QUESTIONS? 4586 02:52:15,725 --> 02:52:15,892 OKAY. 4587 02:52:15,958 --> 02:52:17,493 I WANT TO MAKE SURE EVERYBODY 4588 02:52:17,560 --> 02:52:18,995 HAS VOTED. 4589 02:52:19,062 --> 02:52:21,330 KEITH, I THINK WE CAN -- THANK 4590 02:52:21,397 --> 02:52:21,664 YOU VERY MUCH. 4591 02:52:21,731 --> 02:52:21,998 >> THANK YOU. 4592 02:52:22,065 --> 02:52:27,937 YOU CAN GO TO HAPPY HOUR. 4593 02:52:28,004 --> 02:52:34,844 >> SO PLEASE VOTE FOR ALL THE 4594 02:52:34,911 --> 02:52:35,111 CONCEPTS. 4595 02:52:35,178 --> 02:52:37,914 >> SAVE AND SUBMIT THE VOTE, IT 4596 02:52:37,980 --> 02:52:38,881 WOULD BE APPRECIATED. 4597 02:52:38,948 --> 02:52:40,349 >> SUBMIT IS AT THE TOP OF THE 4598 02:52:40,416 --> 02:52:45,054 PAGE. 4599 02:52:45,121 --> 02:52:46,689 JUST WANT TO REMIND EVERYONE, 4600 02:52:46,756 --> 02:52:49,358 OUR NEXT MEETING IS ON MONDAY, 4601 02:52:49,425 --> 02:52:49,692 SEPTEMBER 9TH. 4602 02:52:49,759 --> 02:52:53,529 IT WILL BE IN THIS ROOM AGAIN. 4603 02:52:53,596 --> 02:52:57,500 BRING YOUR LUNCH, AND WE' IT WIL 4604 02:52:57,567 --> 02:52:58,801 ALSO BE HYBRID FORMAT. 4605 02:52:58,868 --> 02:53:00,136 I THINK IF THERE'S NOTHING 4606 02:53:00,203 --> 02:53:01,237 ELSE -- CARL, DO YOU HAVE -- 4607 02:53:01,304 --> 02:53:02,905 >> THANK YOU ALL FOR YOUR 4608 02:53:02,972 --> 02:53:03,473 ATTENDANCE. 4609 02:53:03,539 --> 02:53:06,409 IT'S REALLY GREAT TO SEE 4610 02:53:06,476 --> 02:53:08,678 EVERYBODY, AND AFTER A 4611 02:53:08,745 --> 02:53:09,746 PRODUCTIVE MEETING. 4612 02:53:09,812 --> 02:53:10,947 USUALLY WE HAVE TIME FOR PUBLIC 4613 02:53:11,013 --> 02:53:12,048 COMMENT. 4614 02:53:12,115 --> 02:53:13,249 NO PUBLIC COMMENT REQUESTS WERE 4615 02:53:13,316 --> 02:53:14,083 RECEIVED. 4616 02:53:14,150 --> 02:53:17,854 SO WE ARE FREE TO ADJOURN. 4617 02:53:17,920 --> 02:53:19,522 >> SO LET'S ADJOURN THE MEETING. 4618 02:53:19,589 THANK YOU, EVERYONE.