1 00:00:05,120 --> 00:00:10,160 I'M KEN FREEBERG AND I WANT TO 2 00:00:10,160 --> 00:00:15,760 WELCOME EVERYONE TODAY. 3 00:00:15,760 --> 00:00:17,160 SEPTEMBER MEETING OF THE AIDS 4 00:00:17,160 --> 00:00:19,640 RESEARCH COMMITTEE OF NIAID AND 5 00:00:19,640 --> 00:00:21,000 WE HAVE A VERY INTERESTING AND 6 00:00:21,000 --> 00:00:22,360 PACKED AGENDA THIS AFTERNOON AND 7 00:00:22,360 --> 00:00:24,120 WE LOOK FORWARD TO HEARING ABOUT 8 00:00:24,120 --> 00:00:29,640 EXCITING NEW SCIENCE BEING 9 00:00:29,640 --> 00:00:30,760 PROPOSED FIRST ORDER OF BUSINESS 10 00:00:30,760 --> 00:00:32,320 IS TRUE AND CONSIDERING APPROVED 11 00:00:32,320 --> 00:00:34,600 THE MINUTES OF OUR JUNE MEETING. 12 00:00:34,600 --> 00:00:36,320 SO I WONDER IF I COULD HAVE A 13 00:00:36,320 --> 00:00:41,120 MOTION TO APPROVE THOSE MINUTES. 14 00:00:41,120 --> 00:00:41,920 >> SO MOVED. 15 00:00:41,920 --> 00:00:43,480 >> SOMEONE SECOND THAT MOTION. 16 00:00:43,480 --> 00:00:44,880 >> WE HAVE SECOND. 17 00:00:44,880 --> 00:00:48,480 >> ALL IN FAVOR OF ACCEPTING 18 00:00:48,480 --> 00:00:49,800 THOSE MINUTES. 19 00:00:49,800 --> 00:00:50,040 >> AYE. 20 00:00:50,040 --> 00:00:53,760 >> ANYONE OPPOSED? 21 00:00:53,760 --> 00:00:54,960 WE WILL APPROVE THE MINUTES OF 22 00:00:54,960 --> 00:01:03,520 THE JUNE MEETING AND THANK YOU, 23 00:01:03,520 --> 00:01:04,680 EVERYONE, I APPRECIATE THAT. 24 00:01:04,680 --> 00:01:05,880 BEFORE I HAPPENED IT OVER TO 25 00:01:05,880 --> 00:01:07,440 Dr. DIEFFENBACH, I WANT TO 26 00:01:07,440 --> 00:01:09,880 TAKE A MOMENT ON BEHALF OF OF 27 00:01:09,880 --> 00:01:12,240 THE AIDS RESEARCH ADVISORY TO 28 00:01:12,240 --> 00:01:15,720 REFLECT AS WHICH OPEN THE 29 00:01:15,720 --> 00:01:17,840 SEPTEMBER TO 22 MEETING WHICH 30 00:01:17,840 --> 00:01:21,320 WILL BE THE LAST MEETING UNDER 31 00:01:21,320 --> 00:01:25,080 THE LEADERSHIP OF ANTHONY FAUCI. 32 00:01:25,080 --> 00:01:28,200 HE HAS LED NIAID SINCE 1984 AND 33 00:01:28,200 --> 00:01:29,840 IT'S REALLY IMPOSSIBLE TO 34 00:01:29,840 --> 00:01:33,240 CAPTURE THE ENORMITY OF HIS 35 00:01:33,240 --> 00:01:35,840 CONTRIBUTIONS AND HIS 36 00:01:35,840 --> 00:01:36,560 EXTRAORDINARY LEADERSHIP OF 37 00:01:36,560 --> 00:01:37,520 NIAID AND THROUGHOUT THE 38 00:01:37,520 --> 00:01:42,000 DIVISION OF AIDS HAS BEEN 39 00:01:42,000 --> 00:01:43,160 UNPARALLEL. 40 00:01:43,160 --> 00:01:44,480 HIS ABILITY TO SEE THE WORLD AND 41 00:01:44,480 --> 00:01:47,000 MAKE IT BETTER HAS BEEN TRULY 42 00:01:47,000 --> 00:01:49,200 ASTONISHING FOR THE MOST 43 00:01:49,200 --> 00:01:52,480 FUNDAMENTAL SCIENTIFIC QUESTIONS 44 00:01:52,480 --> 00:01:53,800 AND TO THE DIFFICULT CLINICAL 45 00:01:53,800 --> 00:01:55,760 PROBLEMS OF OUR LIFETIMES AND TO 46 00:01:55,760 --> 00:01:57,040 THE MANY PUBLIC-HEALTH 47 00:01:57,040 --> 00:02:00,520 CHALLENGES THE WORLD HAS FACED 48 00:02:00,520 --> 00:02:02,280 OVER THE PAST 40 YEARS AND SO 49 00:02:02,280 --> 00:02:07,240 MANY INFECTIOUS AND OTHER 50 00:02:07,240 --> 00:02:08,040 DISEASES. 51 00:02:08,040 --> 00:02:10,200 THEY HAVE PROFOUND LIFE-SAVING 52 00:02:10,200 --> 00:02:11,080 EFFECT ON INDIVIDUALS, 53 00:02:11,080 --> 00:02:12,600 COMMUNITIES AND REALLY ON THE 54 00:02:12,600 --> 00:02:13,280 ENTIRE WORLD. 55 00:02:13,280 --> 00:02:14,920 AND WE, AS A COMMITTEE, WANT TO 56 00:02:14,920 --> 00:02:17,920 THANK HIM ON BEHALF OF PEOPLE 57 00:02:17,920 --> 00:02:19,480 EVERYWHERE AND WE LOOK FORWARD 58 00:02:19,480 --> 00:02:21,600 TO WHAT WILL NO DOUBT BE 59 00:02:21,600 --> 00:02:23,280 CONTINUED EXTRAORDINARY 60 00:02:23,280 --> 00:02:25,640 ACCOMPLISHMENTS AS HE OPENS THE 61 00:02:25,640 --> 00:02:26,880 NEXT CHAPTER. 62 00:02:26,880 --> 00:02:35,400 THANK YOU Dr. ANTHONY, TONY TON 63 00:02:35,400 --> 00:02:35,600 FAUCI. 64 00:02:35,600 --> 00:02:40,040 THANK YOU. 65 00:02:40,040 --> 00:02:42,400 LAND ME AFTER IT OVER TO Dr. 66 00:02:42,400 --> 00:02:46,440 CARL DIEFFENBACH FOR THE 67 00:02:46,440 --> 00:02:47,240 DIRECTOR'S REPORT. 68 00:02:47,240 --> 00:02:49,560 >> I WANT TO THANK YOU KEN FOR 69 00:02:49,560 --> 00:02:54,880 THOSE INCREDIBLY MEANINGFUL 70 00:02:54,880 --> 00:02:55,280 WORDS. 71 00:02:55,280 --> 00:03:00,120 IT'S BEEN A PLEASURE TO BE THE 72 00:03:00,120 --> 00:03:01,920 DIRECTOR OF DIVISION OF AIDS TO 73 00:03:01,920 --> 00:03:07,600 LEAD THE DIVISION SINCE 2008 AND 74 00:03:07,600 --> 00:03:11,120 I THINK WE HAVE APPOINTED 75 00:03:11,120 --> 00:03:12,760 OURSELVES AS WELL AS WE CAN AND 76 00:03:12,760 --> 00:03:18,280 WE CONTINUE TO STRIVE TO MAKE 77 00:03:18,280 --> 00:03:20,280 PROGRESS AGAINST HIV, 78 00:03:20,280 --> 00:03:22,040 SARS-CoV-2, AND NOW MONKEYPOX. 79 00:03:22,040 --> 00:03:25,960 SO, OUR PLATE IS FULL AND WE 80 00:03:25,960 --> 00:03:32,320 WILL CONTINUE TO PUSH FORWARD. 81 00:03:32,320 --> 00:03:33,960 SO, IT'S MY PLEASURE TO WELCOME 82 00:03:33,960 --> 00:03:35,320 YOU TO THE SEPTEMBER MEETING OF 83 00:03:35,320 --> 00:03:39,400 THE AIDS RESEARCH ADVISORY 84 00:03:39,400 --> 00:03:42,280 COMMITTEE AND NEXT SLIDE, 85 00:03:42,280 --> 00:03:42,520 PLEASE. 86 00:03:42,520 --> 00:03:45,440 I WANT TO START BY HONORING 87 00:03:45,440 --> 00:03:49,840 SOMEONE WHO PASSED AWAY AND THE 88 00:03:49,840 --> 00:03:53,280 LAST COUPLE OF WEEKS, NEIL 89 00:03:53,280 --> 00:03:53,760 NATHANSON. 90 00:03:53,760 --> 00:03:55,120 IT'S REALLY IMPORTANT THAT WE 91 00:03:55,120 --> 00:03:55,840 CAN REMEMBER HIM. 92 00:03:55,840 --> 00:03:58,560 I HAD THE PLEASURE OF KNOWING 93 00:03:58,560 --> 00:03:59,760 NEIL WHEN I WAS A GRADUATE 94 00:03:59,760 --> 00:04:01,200 STUDENT AND THE TIME WAS THE 95 00:04:01,200 --> 00:04:03,520 SCHOOL OF HYGIENE AND 96 00:04:03,520 --> 00:04:05,600 PUBLIC-HEALTH AT JOHNS HOPKINS 97 00:04:05,600 --> 00:04:09,800 UNIVERSITY AND WHEN I STARTED 98 00:04:09,800 --> 00:04:14,200 THERE IN 1976 TO WHEN HE THROAT 99 00:04:14,200 --> 00:04:17,600 GO TO PENN IN 1979. 100 00:04:17,600 --> 00:04:19,120 OUR PATHS CROSSED AGAIN YEARS 101 00:04:19,120 --> 00:04:21,440 LATER IN 1998 WHEN HE WAS 102 00:04:21,440 --> 00:04:22,560 APPOINTED DIRECTOR OF THE OFFICE 103 00:04:22,560 --> 00:04:26,480 OF AIDS RESEARCH BY HAROLD 104 00:04:26,480 --> 00:04:26,720 VARMUSS. 105 00:04:26,720 --> 00:04:33,240 AT THAT TIME, HE HAD THIS TO SAA 106 00:04:33,240 --> 00:04:35,120 POWERFUL SCIENTIFIC INTELLECT 107 00:04:35,120 --> 00:04:37,160 GREAT COMPASSION AND LONG 108 00:04:37,160 --> 00:04:38,120 ADMINISTRATIVE EXPERIENCE. 109 00:04:38,120 --> 00:04:42,400 THE TASK TO LEADING THE NIH/AIDS 110 00:04:42,400 --> 00:04:43,520 RESEARCH PROGRAMS AT THIS 111 00:04:43,520 --> 00:04:44,280 CRITICAL TIME. 112 00:04:44,280 --> 00:04:48,760 KEEP IN MIND, WHEN NEIL CAME TO 113 00:04:48,760 --> 00:04:50,760 OAR HE WAS FOLLOWING IN THE 114 00:04:50,760 --> 00:04:52,560 FOOTSTEPS OF BILL PAUL WHO HAD 115 00:04:52,560 --> 00:04:57,280 BEEN BROUGHT INTO HELP IMPLEMENT 116 00:04:57,280 --> 00:04:59,680 THE CHANGES TO OAR AND THE 117 00:04:59,680 --> 00:05:01,160 STRUCTURE OF AIDS RESEARCH 118 00:05:01,160 --> 00:05:02,840 FUNDING THAT BERNIE FIELDS HAD 119 00:05:02,840 --> 00:05:11,160 IDENTIFIED AND PUBLISHED IN THE 120 00:05:11,160 --> 00:05:11,360 MID-90S. 121 00:05:11,360 --> 00:05:15,160 AND HE BUILT STRONGER BRIDGES 122 00:05:15,160 --> 00:05:16,040 BETWEEN THE INSTITUTE AND 123 00:05:16,040 --> 00:05:17,600 CENTERS AND EXPANDING THE ROLE 124 00:05:17,600 --> 00:05:18,640 OF THE INVESTIGATOR COMMUNITY 125 00:05:18,640 --> 00:05:22,880 AND HELPING TO DRAFT THE NIH, 126 00:05:22,880 --> 00:05:24,040 HIV/AIDS STRATEGIC PLAN. 127 00:05:24,040 --> 00:05:27,280 HE WAS ONLY IN THE POSITION FOR 128 00:05:27,280 --> 00:05:30,360 TWO YEARS, HIS CREATIVE AND 129 00:05:30,360 --> 00:05:31,880 POSITIVE INFLUENCE CARRIED 130 00:05:31,880 --> 00:05:33,800 FORWARD AND IS STILL MANY OF HIS 131 00:05:33,800 --> 00:05:39,720 IDEAS ARE STILL IN PLACE TODAY. 132 00:05:39,720 --> 00:05:41,720 I WANTED TO ACKNOWLEDGE KNEEL'S 133 00:05:41,720 --> 00:05:45,800 PASSING SO NEXT SLIDE. 134 00:05:45,800 --> 00:05:51,600 I'M PLEASED TO A NEXT THAT ROBIN 135 00:05:51,600 --> 00:05:52,800 FANFAIR IS JOINING US TODAY AS 136 00:05:52,800 --> 00:05:59,080 AN EX AN EX-OFFICIO MEMBER FILL. 137 00:05:59,080 --> 00:06:00,880 ROBIN IS SERVING AS THE ACTING 138 00:06:00,880 --> 00:06:02,280 DIVISION DIRECTOR AND DIVISION 139 00:06:02,280 --> 00:06:04,680 OF HIV PREVENTION AT CDC AND 140 00:06:04,680 --> 00:06:07,360 PLEASE JOIN ME IN WELCOMING HERE 141 00:06:07,360 --> 00:06:10,240 TODAY AND TO THE ARAC MEETING. 142 00:06:10,240 --> 00:06:11,360 IT'S A PLEASURE TO HAVE YOU WORK 143 00:06:11,360 --> 00:06:11,600 WITH US. 144 00:06:11,600 --> 00:06:12,760 >> THANK YOU SO MUCH FOR THE 145 00:06:12,760 --> 00:06:14,120 WARM WELCOME AND I'M PLEASED TO 146 00:06:14,120 --> 00:06:18,280 BE HERE. 147 00:06:18,280 --> 00:06:27,000 NEXT SLIDE, PLEASE. 148 00:06:27,000 --> 00:06:28,200 I'D LIKE UP TO DATE YOU ON OUR 149 00:06:28,200 --> 00:06:28,480 BUDGET. 150 00:06:28,480 --> 00:06:30,040 THOSE WHO AWE Dr. FAUCI'S 151 00:06:30,040 --> 00:06:31,120 PRESENTATION THIS MORNING HAVE 152 00:06:31,120 --> 00:06:34,640 SEEN THESE SLIDES WHERE HE 153 00:06:34,640 --> 00:06:38,760 TALKED ABOUT WHERE WE WERE IN 154 00:06:38,760 --> 00:06:41,000 FISCAL YEAR 2022 AND WHAT WE'RE 155 00:06:41,000 --> 00:06:46,520 LOOKING AT IS A HOUSE MARK OF A 156 00:06:46,520 --> 00:06:48,040 5.1% INCREASE AND A SENATE MARK 157 00:06:48,040 --> 00:06:52,160 OF A 2% INCREASE. 158 00:06:52,160 --> 00:06:53,640 WE DON'T HAVE A SENSE OF WHERE 159 00:06:53,640 --> 00:06:55,200 WE'LL END UP AT THE END OF THE 160 00:06:55,200 --> 00:06:57,360 DAY. 161 00:06:57,360 --> 00:06:58,520 IMPORTANTLY, THIS IS IN RED AT 162 00:06:58,520 --> 00:07:00,920 THE BOTTOM HERE IS THESE NUMBERS 163 00:07:00,920 --> 00:07:04,480 EXCLUDE THE OAR TRANSFER SO THE 164 00:07:04,480 --> 00:07:05,800 FINAL BUDGET THAT THE DIVISION 165 00:07:05,800 --> 00:07:11,680 OF AIDS WILL HAVE WILL BE FORMED 166 00:07:11,680 --> 00:07:13,560 AFTER THE APPROPRIATIONS BILL 167 00:07:13,560 --> 00:07:19,840 HAS FORMALLY BEEN PASSED. 168 00:07:19,840 --> 00:07:22,960 SO, AS WE DO EVERY YEAR, WHEN WE 169 00:07:22,960 --> 00:07:24,760 KNOW WE'RE STARTING UNDER A 170 00:07:24,760 --> 00:07:25,840 CONTINUING RESOLUTION WE START 171 00:07:25,840 --> 00:07:31,200 AT A VERY CONSERVATIVE POSITION 172 00:07:31,200 --> 00:07:32,000 PLANNING FOR THE WORSE THE AND 173 00:07:32,000 --> 00:07:32,840 HOPING FOR THE BEST. 174 00:07:32,840 --> 00:07:36,760 WE'LL START WITH AN ESTABLISHED 175 00:07:36,760 --> 00:07:37,680 PAYLINE FOR ESTABLISHED 176 00:07:37,680 --> 00:07:39,040 PRINCIPLE INVESTIGATORS OF THE 177 00:07:39,040 --> 00:07:42,360 TENTH PERCENTILE IN UPIs AT 178 00:07:42,360 --> 00:07:45,840 THE 14% STYLE AND THEY WILL 179 00:07:45,840 --> 00:07:47,480 HAVEN'T ANY ADJUSTMENTS AND AT 180 00:07:47,480 --> 00:07:50,320 THIS POINT IN TIME COMPETING 181 00:07:50,320 --> 00:07:51,600 RESEARCH INITIATIVES HAVE BEEN 182 00:07:51,600 --> 00:07:55,440 TENTATIVELY SET FOURTH WITH A 183 00:07:55,440 --> 00:07:58,160 20% CUT IF THIS STAYED AS OUR 184 00:07:58,160 --> 00:07:59,280 FULL FINANCIAL MANAGEMENT PLAN 185 00:07:59,280 --> 00:08:01,960 FOR THE YEAR, WE WOULD HAVE AN 186 00:08:01,960 --> 00:08:03,480 ESTIMATED SUCCESS RATE OF 187 00:08:03,480 --> 00:08:06,080 BETWEEN 18 AND 22%. 188 00:08:06,080 --> 00:08:10,920 NOW, TYPICALLY, WHEN WE GET A 189 00:08:10,920 --> 00:08:13,440 BUDGET, THESE NUMBERS WILL 190 00:08:13,440 --> 00:08:16,040 INCREASE AND HOPEFULLY WE'LL 191 00:08:16,040 --> 00:08:17,600 HAVE THAT EARLY IN THE FISCAL 192 00:08:17,600 --> 00:08:24,360 YEAR AS WE GO FORWARD. 193 00:08:24,360 --> 00:08:28,080 SO, ONE OF THE THINGS WE TALKED 194 00:08:28,080 --> 00:08:30,480 ABOUT AT THE MOST RECENT MEETING 195 00:08:30,480 --> 00:08:32,520 WAS DIVERSITY, EQUITY, INCLUSION 196 00:08:32,520 --> 00:08:35,080 AND ACCESSIBILITY AND LIKE Dr. 197 00:08:35,080 --> 00:08:38,000 FAUCI TALKED ABOUT TODAY, I HAD 198 00:08:38,000 --> 00:08:42,080 MADE A PLEDGE TO BE AT THE 199 00:08:42,080 --> 00:08:46,920 DIVISION WAS GOING TO PUT DEAI 200 00:08:46,920 --> 00:08:48,360 CONSIDERATIONS AS PART THE OF 201 00:08:48,360 --> 00:08:49,240 EVERY FUNDING ACTION AND 202 00:08:49,240 --> 00:08:49,960 EVERYTHING THAT WE'RE 203 00:08:49,960 --> 00:08:53,680 CONSIDERING AS WE GO FORWARD IN 204 00:08:53,680 --> 00:08:55,560 OUR RESEARCH PLAN. 205 00:08:55,560 --> 00:08:57,280 I ALSO SAID I WOULD COME TO YOU 206 00:08:57,280 --> 00:09:00,440 AT EVERY MEETING AND TALK ABOUT 207 00:09:00,440 --> 00:09:03,480 WHAT WE HAVE DONE OR WHAT WE ARE 208 00:09:03,480 --> 00:09:05,600 DOING IN THE AREA OF HIGH VERSE 209 00:09:05,600 --> 00:09:07,120 TEE, EQUITY AND INCLUSION AND 210 00:09:07,120 --> 00:09:12,240 THIS IS THE FIRST ARAC MEETING. 211 00:09:12,240 --> 00:09:13,760 I THOUGHT I WOULD HIGHLIGHT A 212 00:09:13,760 --> 00:09:15,960 COUPLE OF ACTIVITIES THAT ARE ON 213 00:09:15,960 --> 00:09:17,160 GOING AND SOME NEW THINGS THAT 214 00:09:17,160 --> 00:09:20,120 WE'RE STARTING AND LOOK AT THEM 215 00:09:20,120 --> 00:09:22,840 THROUGH THE LENS ABOUT HOW THEY 216 00:09:22,840 --> 00:09:25,680 HAVE HAD AN IMPACT AND SOME OF 217 00:09:25,680 --> 00:09:27,520 THESE THINGS HAVE BEEN GOING FOR 218 00:09:27,520 --> 00:09:32,160 O.P.P. FOR A WHILE AND THIS IS 219 00:09:32,160 --> 00:09:35,800 NOT A FAD THAT WE HAVE SUDDENLY 220 00:09:35,800 --> 00:09:36,080 FOUND. 221 00:09:36,080 --> 00:09:37,560 MANY OF THESE HAVE BEEN GOING ON 222 00:09:37,560 --> 00:09:39,640 FOR A REL 223 00:09:39,640 --> 00:09:43,120 RELATIVITY LONG PERIOD OF TIME. 224 00:09:43,120 --> 00:09:45,320 THEY HAD A PROGRAM THAT START 225 00:09:45,320 --> 00:09:47,680 INSIDE 2015 DESIGNED TO FUND 226 00:09:47,680 --> 00:09:49,840 MENTORED TRAINING PROJECTS FOR 227 00:09:49,840 --> 00:09:51,000 DECREASING HEALTH RELATED 228 00:09:51,000 --> 00:09:53,640 DISPARITIES IN THE HISPANIC AND 229 00:09:53,640 --> 00:09:55,880 LATINO COMMUNITY CALLED 230 00:09:55,880 --> 00:09:57,040 ADELANTE. 231 00:09:57,040 --> 00:10:03,880 A NEW PROGRAM ON ITS SECOND 232 00:10:03,880 --> 00:10:10,440 YEAR, THE -- THIS IS A 233 00:10:10,440 --> 00:10:12,080 INTERESTING PROGRAM DESIGNED TO 234 00:10:12,080 --> 00:10:15,000 ENHANCE EXISTING PROGRAMS AND IN 235 00:10:15,000 --> 00:10:17,320 THE DEVELOPMENT OF NEW WITHIN 236 00:10:17,320 --> 00:10:19,520 THE CFAR NETWORK FOR 237 00:10:19,520 --> 00:10:21,080 COLLABORATION WITH HISTORICALLY 238 00:10:21,080 --> 00:10:22,120 BLACK COLLEGES, UNIVERSITIES AND 239 00:10:22,120 --> 00:10:26,680 OTHER MINORITY-SERVING 240 00:10:26,680 --> 00:10:30,360 INSTITUTIONS. 241 00:10:30,360 --> 00:10:31,360 I KNOW THEY ARE INTERESTED AND 242 00:10:31,360 --> 00:10:33,840 COMMITTED TO AND I SEE THIS 243 00:10:33,840 --> 00:10:34,960 PROGRAM GROWING IN IMPORTANCE 244 00:10:34,960 --> 00:10:35,840 OVER TIME. 245 00:10:35,840 --> 00:10:37,720 THE ONE THING ABOUT THIS PROGRAM 246 00:10:37,720 --> 00:10:38,680 THAT'S DIFFERENT THAN OTHER 247 00:10:38,680 --> 00:10:47,320 THINGS WE DO, THIS A LOUSE ALLOO 248 00:10:47,320 --> 00:10:48,480 REACH UNDERGRADUATE AND HIGH 249 00:10:48,480 --> 00:10:49,560 SCHOOL LEVEL TO HELP BRING 250 00:10:49,560 --> 00:10:51,920 FORWARD THE NEXT GENERATION SO 251 00:10:51,920 --> 00:10:54,200 YOU ARE NOT WAITING FOR SOMEONE 252 00:10:54,200 --> 00:10:56,600 TO MATRICULATE IN A MEDICAL 253 00:10:56,600 --> 00:10:58,320 SCHOOL OR GRADUATE SCHOOL BUT 254 00:10:58,320 --> 00:11:00,200 GET THEM AT THE UNDERGRADUATE 255 00:11:00,200 --> 00:11:01,640 LEVEL AND GET THEM INTERESTED IN 256 00:11:01,640 --> 00:11:03,280 AIDS RESEARCH AND INVOLVED IN 257 00:11:03,280 --> 00:11:04,720 AIDS RESEARCH AND GET STEM 258 00:11:04,720 --> 00:11:06,040 STUDENTS AT THE HIGH SCHOOL 259 00:11:06,040 --> 00:11:06,640 LEVEL ENGAGE. 260 00:11:06,640 --> 00:11:10,120 THIS IS A VERY IMPORTANT PROGRAM 261 00:11:10,120 --> 00:11:12,040 AND WE'RE LOOKING FORWARD TO 262 00:11:12,040 --> 00:11:12,960 SEEING IT GROW. 263 00:11:12,960 --> 00:11:15,560 WITHIN THE HIV EPIDEMIC 264 00:11:15,560 --> 00:11:20,920 INITIATIVES, THAT WE HAVE HAD, 265 00:11:20,920 --> 00:11:22,800 FOCUSED ON EQUITY, FOCUSED 266 00:11:22,800 --> 00:11:25,080 APPROACHES TO REDUCE HIV-RELATED 267 00:11:25,080 --> 00:11:27,600 HEALTH DISPARITIES AND THE CYCLE 268 00:11:27,600 --> 00:11:30,720 WE FUNDED 25 PROJECTS AND 18 TO 269 00:11:30,720 --> 00:11:34,080 CFAR AND SEVEN TO THE NIH/AIDS 270 00:11:34,080 --> 00:11:35,520 RESEARCH CENTER SO AGAIN, THIS 271 00:11:35,520 --> 00:11:37,800 IS NOT JUST ABOUT THE DIVISION 272 00:11:37,800 --> 00:11:40,520 BUT ACROSS NIH PROGRAMS 273 00:11:40,520 --> 00:11:43,600 INVOLVING NIMH AS WELL. 274 00:11:43,600 --> 00:11:46,320 IN TERMS OF SOME OTHER 275 00:11:46,320 --> 00:11:49,960 ACTIVITIES, WE HAVE REISSUED A 276 00:11:49,960 --> 00:11:51,480 PROGRAM ANNOUNCEMENT TO 277 00:11:51,480 --> 00:11:54,320 TRANSGENDER PEOPLE, IMMUNITY 278 00:11:54,320 --> 00:11:56,200 TREATMENT AND PREVENTION OF HIV 279 00:11:56,200 --> 00:11:58,440 AND STIs. 280 00:11:58,440 --> 00:12:02,680 THIS REALLY HAP REAL HELPS US UD 281 00:12:02,680 --> 00:12:05,400 THE BIOLOGY AND SCIO BIOLOGY 282 00:12:05,400 --> 00:12:07,440 WITH TRANS PEOPLE AND AS AN 283 00:12:07,440 --> 00:12:08,640 EXAMPLE OF ONE OF THE PROGRAMS 284 00:12:08,640 --> 00:12:10,760 THE NETWORKS ARE SUPPORTING, IS 285 00:12:10,760 --> 00:12:14,720 THE MINORITY HIV INVESTIGATOR 286 00:12:14,720 --> 00:12:17,920 MENTORING PROGRAM AND HAKEEN 287 00:12:17,920 --> 00:12:18,720 INTERNATIONAL INVESTIGATOR 288 00:12:18,720 --> 00:12:20,120 MENTORING PROGRAM WHICH ARE 289 00:12:20,120 --> 00:12:23,160 ADMINISTERED BY THE ACTG UNDER 290 00:12:23,160 --> 00:12:26,680 REPRESENTED POPULATION 291 00:12:26,680 --> 00:12:28,320 COMMITTEES. 292 00:12:28,320 --> 00:12:29,360 THESE PROGRAMS ENGAGE IN 293 00:12:29,360 --> 00:12:30,560 SCIENCES IN THE HIV FIELD. 294 00:12:30,560 --> 00:12:32,200 THERE ARE OTHER NETWORKS WITH 295 00:12:32,200 --> 00:12:35,000 SIMILAR PROGRAMS SUCH AS THE 296 00:12:35,000 --> 00:12:36,320 HPTN SCHOLARS THAT HAVE BEEN 297 00:12:36,320 --> 00:12:38,960 INCREDIBLY POWERFUL IN BRINGING 298 00:12:38,960 --> 00:12:43,600 FORWARD UP-AND-COMING MINORITY 299 00:12:43,600 --> 00:12:46,440 INVESTIGATORS THAT HAVE BEEN 300 00:12:46,440 --> 00:12:48,920 ABLE TO REACH THEIR GOALS FASTER 301 00:12:48,920 --> 00:12:50,680 THROUGH THIS KIND OF 302 00:12:50,680 --> 00:12:51,120 ACCELERATION. 303 00:12:51,120 --> 00:12:52,320 WHAT I'D LIKE TO SPEND A LITTLE 304 00:12:52,320 --> 00:12:56,360 BIT MORE TIME ON TODAY, IS THE 305 00:12:56,360 --> 00:12:57,640 HANK LEGACY PROJECT DEVELOPED 306 00:12:57,640 --> 00:12:59,160 SOMETHING CALLED THE REP RESEN 307 00:12:59,160 --> 00:13:02,160 TIVE STUDIES RUBRIC TO HELP 308 00:13:02,160 --> 00:13:03,440 ENSURE THAT WE ARE MEETING THE 309 00:13:03,440 --> 00:13:07,760 NEEDS OF THE DIVERSE 310 00:13:07,760 --> 00:13:09,400 REPRESENTATION OF PARTICIPANTS 311 00:13:09,400 --> 00:13:10,600 IN OUR CLINICAL SEARCH. 312 00:13:10,600 --> 00:13:12,880 THIS IS MORE ABOUT THE RSR OR 313 00:13:12,880 --> 00:13:16,760 REPRESENTATIVE STUDIES RUBRIC. 314 00:13:16,760 --> 00:13:18,480 THEY WERE ABLE TO GO DOWN TIE 315 00:13:18,480 --> 00:13:20,440 POINT WHERE THEY HAD 12-ITEM 316 00:13:20,440 --> 00:13:22,680 QUESTIONNAIRE AND THAT COULD BE 317 00:13:22,680 --> 00:13:25,040 APPLIED TO STUD OWE PROTOCOLS TO 318 00:13:25,040 --> 00:13:27,240 FACILITATE ENHANCED INCLUSION OF 319 00:13:27,240 --> 00:13:29,760 UNDER REPRESENTED POPULATIONS IN 320 00:13:29,760 --> 00:13:31,360 THE PROTOCOL. 321 00:13:31,360 --> 00:13:33,360 THEY DID IS EXAM INDIVIDUAL 322 00:13:33,360 --> 00:13:35,240 STUDY PROTOCOLS FOR THEIR 323 00:13:35,240 --> 00:13:36,560 REPRESENTATION OF PEOPLE BASED 324 00:13:36,560 --> 00:13:39,160 ON AGE AND ETHNICITY, GENDER, 325 00:13:39,160 --> 00:13:40,800 AND INJECTION DRUG USE, 326 00:13:40,800 --> 00:13:43,640 PREGNANCY RACE, AND SEX ASSIGNED 327 00:13:43,640 --> 00:13:44,320 AT BIRTH. 328 00:13:44,320 --> 00:13:48,160 SO USING THIS RUBRIC, THE 329 00:13:48,160 --> 00:13:50,680 ANALYSIS COVERED 46 NETWORK 330 00:13:50,680 --> 00:13:53,920 STUDIES AND THAT'S COMPLETED IN 331 00:13:53,920 --> 00:13:54,160 2021. 332 00:13:54,160 --> 00:13:56,160 WHAT WE WERE ABLE TO SEE-THROUGH 333 00:13:56,160 --> 00:13:58,880 THIS ANALYSIS, WAS A WIDESPREAD 334 00:13:58,880 --> 00:14:00,760 SYSTEMATIC EXCLUSION OF UNDER 335 00:14:00,760 --> 00:14:05,120 REPRESENTED POPULATIONS AND IT 336 00:14:05,120 --> 00:14:15,600 WAS MOST OFTEN THE GOAL IS TO 337 00:14:23,040 --> 00:14:33,480 DETERMINE HOW BEST TO OPTIMIZE 338 00:14:40,200 --> 00:14:43,840 UNINTENTIONALLY EXCLUDE KEY 339 00:14:43,840 --> 00:14:50,600 POPULATIONS SOME OF THE THINGS 340 00:14:50,600 --> 00:14:55,440 THAT PEOPLE ARE EXCLUDED FOR WE 341 00:14:55,440 --> 00:15:03,240 DON'T NEED TO EXCLUDE IN AN 342 00:15:03,240 --> 00:15:05,720 ININTENTIONAL WAY. 343 00:15:05,720 --> 00:15:07,520 WHERE WE ARE ON OUR COVID 344 00:15:07,520 --> 00:15:08,000 STUDIES. 345 00:15:08,000 --> 00:15:08,600 MANY OF YOU WHO HAVE 346 00:15:08,600 --> 00:15:10,360 PARTICIPATED IN ACTIVE 2D 347 00:15:10,360 --> 00:15:13,720 REALIZE WE'RE IN LONG-TERM 348 00:15:13,720 --> 00:15:16,520 SAFETY FOLLOW-UP IN EFFICACY OF 349 00:15:16,520 --> 00:15:18,880 A SET OF AGENTS, NO NEW AGENTS 350 00:15:18,880 --> 00:15:23,560 HAVE COME INTO ACTIVE 2D AND 351 00:15:23,560 --> 00:15:24,840 IT'SEN ROLLING IN THE UNITED 352 00:15:24,840 --> 00:15:27,680 STATES AND THAT IS LOOKING AT 353 00:15:27,680 --> 00:15:36,760 THE SHINOGI-66662 PROTEASOME 354 00:15:36,760 --> 00:15:38,000 INHIBITOR AND ALL THE COVID-19 355 00:15:38,000 --> 00:15:39,400 STUDIES ARE ENROLLED AND IN 356 00:15:39,400 --> 00:15:41,400 SAFETY FOLLOW-UP OR AT A POINT 357 00:15:41,400 --> 00:15:43,920 NOW WHERE THEY'RE NEARLY 358 00:15:43,920 --> 00:15:44,160 COMPLETED. 359 00:15:44,160 --> 00:15:50,360 AS YOU ARE AWARE, MODERNA mRNA 360 00:15:50,360 --> 00:15:53,600 1273 WAS APPROVED AS A TWO-DOSE 361 00:15:53,600 --> 00:15:56,600 PRIMARY SERIES AND LICENSED 18 362 00:15:56,600 --> 00:15:57,520 AND OVER. 363 00:15:57,520 --> 00:16:00,640 IT RECEIVED EUA APPROVAL AT A 364 00:16:00,640 --> 00:16:03,480 LOWER DOSE FOR SIX MONTHS AND 365 00:16:03,480 --> 00:16:06,320 UP. 366 00:16:06,320 --> 00:16:07,120 AND NOW MORDECHAI BIVALENT BOOST 367 00:16:07,120 --> 00:16:10,800 WHICH INCLUDES THE ANCESTORIAL 368 00:16:10,800 --> 00:16:13,920 AS WELL AS THE OMICRON BA.4/5 369 00:16:13,920 --> 00:16:16,120 HAS RECEIVED AN EUA FOR 370 00:16:16,120 --> 00:16:17,280 INDIVIDUALS 18 AND ABOVE. 371 00:16:17,280 --> 00:16:18,800 IT'S THE EXPECTATION THAT WITHIN 372 00:16:18,800 --> 00:16:23,160 THE NEXT COUPLE OF WEEKS, THE 373 00:16:23,160 --> 00:16:26,880 FDA WILL OR THE CDC WILL MAKE 374 00:16:26,880 --> 00:16:30,040 RECOMMENDATIONS ON EXTENDING THE 375 00:16:30,040 --> 00:16:33,520 AGE FOR THE BIVALENT BOOST. 376 00:16:33,520 --> 00:16:35,440 NOVAVAX HAS BEEN ISSUED FOR THE 377 00:16:35,440 --> 00:16:37,280 PROTEIN, WHICH IS A TWO-DOSE 378 00:16:37,280 --> 00:16:38,720 PRIMARY SERIES AND I KNOW THIS 379 00:16:38,720 --> 00:16:40,080 IS AVAILABLE BECAUSE IN LOOKING 380 00:16:40,080 --> 00:16:41,360 AROUND WHERE I CAN GET MY 381 00:16:41,360 --> 00:16:43,360 BOOSTER THIS WEEKEND, I SAW 382 00:16:43,360 --> 00:16:45,640 PLACES OFFERING THE NOVAVAX 383 00:16:45,640 --> 00:16:47,320 VACCINE AS A PRIMARY SERIES, 384 00:16:47,320 --> 00:16:50,920 WHICH IS GREAT TO SEE. 385 00:16:50,920 --> 00:16:53,280 THE EUA PACKAGE HAS BEEN 386 00:16:53,280 --> 00:16:57,720 SUBMITTED AND FOR IT'S PRIMARY 387 00:16:57,720 --> 00:17:00,480 SERIES AND THERE'S AN INDICATION 388 00:17:00,480 --> 00:17:06,920 WITH A BETA BIVALENT VACCINE. 389 00:17:06,920 --> 00:17:08,440 SO, ONE OF THE THINGS THAT WE 390 00:17:08,440 --> 00:17:10,360 PRIDE OURSELVES ON IS AS WE 391 00:17:10,360 --> 00:17:12,000 DEVELOP TECHNOLOGIES AND WE HAVE 392 00:17:12,000 --> 00:17:15,280 THESE VERY LARGE GRANTS, LIKE 393 00:17:15,280 --> 00:17:19,120 THE IPCMEDs, WE ENCOURAGE 394 00:17:19,120 --> 00:17:20,840 PEOPLE TO SHARE THE INFORMATION 395 00:17:20,840 --> 00:17:23,920 THAT THEY GATHERED AND TO REALLY 396 00:17:23,920 --> 00:17:25,440 HELP ADVANCE SCIENCE. 397 00:17:25,440 --> 00:17:27,760 ONE OF THE THINGS THAT THE DUKE 398 00:17:27,760 --> 00:17:30,800 GROUP HAS DONE, IS THEY HAVE 399 00:17:30,800 --> 00:17:32,440 DEVELOPED SIGNIFICANTLY 400 00:17:32,440 --> 00:17:35,840 PROTOCOLS FOR THE DEVELOPMENT OF 401 00:17:35,840 --> 00:17:40,000 AN mRNA-LNP-TYPE VACCINE AND 402 00:17:40,000 --> 00:17:44,280 HOW TO SHARE IT. 403 00:17:44,280 --> 00:17:46,640 DUKE HAS SHARED WITH WITH 404 00:17:46,640 --> 00:17:48,720 COLLABORATORS AND THE GOAL IS TO 405 00:17:48,720 --> 00:17:51,040 HELP MAKE THE MESSENGER mRNA 406 00:17:51,040 --> 00:17:53,960 TECHNOLOGY A TRUE PLATFORM FOR 407 00:17:53,960 --> 00:17:58,800 RESEARCH AND THEY'RE 408 00:17:58,800 --> 00:17:59,600 COLLABORATING WITH THE NIAID 409 00:17:59,600 --> 00:18:01,280 VACCINE RESEARCH CENTER WITH A 410 00:18:01,280 --> 00:18:06,160 GROUP CALLED AFRIGEN AND A 411 00:18:06,160 --> 00:18:06,720 W.H.O.-mRNA HUB. 412 00:18:06,720 --> 00:18:08,240 WE'RE TRYING TO GET THE 413 00:18:08,240 --> 00:18:10,760 TECHNOLOGY THAT WE'RE DEVELOP 414 00:18:10,760 --> 00:18:11,440 RECOGNIZE MAIN STREAMED IN A WAY 415 00:18:11,440 --> 00:18:13,920 THAT WILL REALLY HELP TO FOSTER 416 00:18:13,920 --> 00:18:20,080 AND SPEED UP DEVELOPMENT OF 417 00:18:20,080 --> 00:18:30,280 SPECIFIC mRNA IN THE FUTURE. 418 00:18:30,280 --> 00:18:33,360 THERE ARE FIVE PILLARS OF 419 00:18:33,360 --> 00:18:36,040 ADDRESSING GAPS AND IMMUNOLOGY 420 00:18:36,040 --> 00:18:38,720 AND UNDERSTANDING TRANSMISSION, 421 00:18:38,720 --> 00:18:41,080 FOSTERING DEVELOPMENT OF NEW 422 00:18:41,080 --> 00:18:43,200 DIAGNOSTICS AND EVALUATING NEW 423 00:18:43,200 --> 00:18:44,880 TREATMENT STRATEGIES AND 424 00:18:44,880 --> 00:18:46,240 EXISTING IN NEW TREATMENT 425 00:18:46,240 --> 00:18:48,840 STRATEGIES AND OPTIMIZING AND 426 00:18:48,840 --> 00:18:50,240 ADVANCING THE VACCINE REGIMENTS. 427 00:18:50,240 --> 00:18:51,320 NEXT SLIDE, PLEASE. 428 00:18:51,320 --> 00:18:54,800 TO THAT END, THE DIVISION OF 429 00:18:54,800 --> 00:18:57,080 AIDS AND THE ACHG, FOR THOSE 430 00:18:57,080 --> 00:18:59,080 THAT SAW TONY'S TALK THIS 431 00:18:59,080 --> 00:19:04,120 MORNING, REALIZED A TRIAL CALLED 432 00:19:04,120 --> 00:19:13,440 A541A OR STUDY OF TECROVIRIMAT 433 00:19:13,440 --> 00:19:14,720 FOR THE TREATMENT OF HUMAN 434 00:19:14,720 --> 00:19:16,080 MONKEYPOX HAS STARTED. 435 00:19:16,080 --> 00:19:18,280 TO VALUE WAIT THE SAFETY AND 436 00:19:18,280 --> 00:19:20,040 ADVOCACY FOR THE TREATMENT OF 437 00:19:20,040 --> 00:19:23,160 HUMAN MONKEYPOX DISEASE. 438 00:19:23,160 --> 00:19:24,360 OBVIOUSLY, WHAT WE ARE SEEKING 439 00:19:24,360 --> 00:19:29,800 IS FASTER CLINICAL RESOLUTION OF 440 00:19:29,800 --> 00:19:31,920 THE POX LESIONS COMPARED TO 441 00:19:31,920 --> 00:19:32,120 PLACEBO. 442 00:19:32,120 --> 00:19:35,320 KEEP IN MIND, THIS IS A 2-1 443 00:19:35,320 --> 00:19:36,480 RANDOMIZATION SO WE'RE REALLY 444 00:19:36,480 --> 00:19:38,240 STACKING THE DECK IN FAVOR OF 445 00:19:38,240 --> 00:19:40,960 GETTING PEOPLE TREATED. 446 00:19:40,960 --> 00:19:43,680 AND WE'RE DOING LOOKING AT TIMED 447 00:19:43,680 --> 00:19:45,920 RESOLUTION AND THE END POINT IS 448 00:19:45,920 --> 00:19:49,400 CLINICAL RESOLUTION IS WHEN ALL 449 00:19:49,400 --> 00:19:53,440 SKIN LESIONS ARE SCABBED OVER 450 00:19:53,440 --> 00:20:03,040 AND ALL ADVISABLE MUCOLAL 451 00:20:03,040 --> 00:20:05,640 LESIONS ARE SCABBED. 452 00:20:05,640 --> 00:20:10,800 THEY'RE GOING TO LOOK AT THE 453 00:20:10,800 --> 00:20:14,040 FRACTIONAL DOSING NEEDED IT'S 454 00:20:14,040 --> 00:20:16,040 IMPORTANT WE GET NOT JUST SAFETY 455 00:20:16,040 --> 00:20:25,240 DATA BUT ALSO SOME P.K. DATA ON 456 00:20:25,240 --> 00:20:26,160 TECOVIRIMAT AND BECAUSE AT THE 457 00:20:26,160 --> 00:20:27,840 OWNED OF THE DAY, WE COULD GET 458 00:20:27,840 --> 00:20:29,840 IN A SITUATION WHERE THIS 459 00:20:29,840 --> 00:20:31,640 DISEASE WAS NOT JUST CONFINED TO 460 00:20:31,640 --> 00:20:40,320 ONE POPULATION. 461 00:20:40,320 --> 00:20:42,160 THIS IS ACTUALLY THREE ARMS. 462 00:20:42,160 --> 00:20:43,640 THE 2/1 RANDOMIZATION. 463 00:20:43,640 --> 00:20:48,080 THERE'S AN INTENSIVE SUB STUDY 464 00:20:48,080 --> 00:20:52,000 LOOKING AT PK. OF 100 PEOPLE IN 465 00:20:52,000 --> 00:20:55,800 THE RANDOMIZED GROUP. 466 00:20:55,800 --> 00:20:57,400 AND YOU CAN SEE THE REST OF THE 467 00:20:57,400 --> 00:20:58,080 DETAILS THERE. 468 00:20:58,080 --> 00:21:00,320 SO ENROLLMENT IS ELIGIBLE DOWN 469 00:21:00,320 --> 00:21:06,680 TO THREE KILOGRAMS SO RELATIVELY 470 00:21:06,680 --> 00:21:08,080 YOUNG CHILDREN WOULD BE 471 00:21:08,080 --> 00:21:08,960 ELIGIBLE. 472 00:21:08,960 --> 00:21:11,080 QUITE YOUNG CHILDREN LIKE THE 473 00:21:11,080 --> 00:21:14,720 TIME OF BIRTH WOULD BE ELIGIBLE 474 00:21:14,720 --> 00:21:15,720 TO PURPOSE IN THE STUDY. 475 00:21:15,720 --> 00:21:17,960 THE PRIMARY OUTCOME IS TIME TO 476 00:21:17,960 --> 00:21:19,080 CLINICAL RESOLUTION AND THE 477 00:21:19,080 --> 00:21:21,320 DURATION OF FOLLOW-UP IS 57 DAYS 478 00:21:21,320 --> 00:21:24,840 AND AS I WAS SAYING THERE'S A 479 00:21:24,840 --> 00:21:26,600 WEIGHT-BASED TECH ROW VERA MAT 480 00:21:26,600 --> 00:21:29,480 PART OF THIS AND IT IS DEALT 481 00:21:29,480 --> 00:21:39,880 WITH IN THE PROTOCOL. 482 00:21:43,800 --> 00:21:45,360 WE ARE SCHEDULED FOR THE JANUARY 483 00:21:45,360 --> 00:21:46,760 MEETING TO BE VIRTUAL AS WELL. 484 00:21:46,760 --> 00:21:48,520 WE ARE IN DISCUSSIONS NOW AS TO 485 00:21:48,520 --> 00:21:50,480 WHETHER WE'RE GOING TO HAVE AN 486 00:21:50,480 --> 00:21:54,800 AVRS MEETING AT THE ASSOCIATED 487 00:21:54,800 --> 00:21:56,800 WITH THE JANUARY MEETING THAT 488 00:21:56,800 --> 00:21:57,680 REMAINS TO BE SEEN. 489 00:21:57,680 --> 00:21:59,680 SO THE SOONEST WE COULD BE 490 00:21:59,680 --> 00:22:03,480 IN-PERSON WOULD BE JUNE 5th OF 491 00:22:03,480 --> 00:22:03,720 2023. 492 00:22:03,720 --> 00:22:06,680 SO S. I'LL STOP THERE AND ANSWER 493 00:22:06,680 --> 00:22:06,960 QUESTIONS. 494 00:22:06,960 --> 00:22:07,720 >> GREAT. 495 00:22:07,720 --> 00:22:09,560 THANK YOU. 496 00:22:09,560 --> 00:22:13,880 THANK YOU, Dr. DIEFFENBACH. 497 00:22:13,880 --> 00:22:14,200 QUESTIONS? 498 00:22:14,200 --> 00:22:15,000 >> THIS IS KEITH. 499 00:22:15,000 --> 00:22:16,960 I HAVE A QUESTION. 500 00:22:16,960 --> 00:22:18,160 YOU TALKED ABOUT THE 501 00:22:18,160 --> 00:22:19,480 REPRESENTATIVE STUDIES RUBRIC 502 00:22:19,480 --> 00:22:22,520 AND IT JUST -- WHAT STRUCK ME IS 503 00:22:22,520 --> 00:22:24,720 THERE'S UNINTENDED EXCLUSION 504 00:22:24,720 --> 00:22:26,960 OCCURRING SO WHAT IS THE PLAN 505 00:22:26,960 --> 00:22:28,960 FOR LESSONS LEARNED HERE AND 506 00:22:28,960 --> 00:22:31,680 GETTING THESE OUT TO EVERYBODY 507 00:22:31,680 --> 00:22:33,120 SO THAT WE CAN ALL MAKE SURE 508 00:22:33,120 --> 00:22:34,640 THAT WE DON'T MAKE THE SAME 509 00:22:34,640 --> 00:22:34,960 MISTAKES? 510 00:22:34,960 --> 00:22:36,920 >> YEAH, SO THAT IS EXACTLY WHAT 511 00:22:36,920 --> 00:22:38,600 IS GOING ON RIGHT NOW. 512 00:22:38,600 --> 00:22:41,200 SO HANK AND OTHERS ARE PILOTING 513 00:22:41,200 --> 00:22:43,080 THIS WITHIN PROTOCOL DEVELOPMENT 514 00:22:43,080 --> 00:22:45,080 WITHIN EVERY NETWORK SO THAT WE 515 00:22:45,080 --> 00:22:50,080 ARE MORE PRECISE IN OUR LANGUAGE 516 00:22:50,080 --> 00:22:55,320 AND AS WE GO FORWARD AND LET IT 517 00:22:55,320 --> 00:22:57,720 OUT OTHER INVESTIGATORS THAT 518 00:22:57,720 --> 00:22:59,400 NEED THIS AS WELL. 519 00:22:59,400 --> 00:23:01,360 IT IS ACTIVELY GOING ON AND 520 00:23:01,360 --> 00:23:04,480 THANK YOU SEATTLE, THANK YOU TO 521 00:23:04,480 --> 00:23:08,680 HANK AND THE LEGACY TEAM FOR 522 00:23:08,680 --> 00:23:10,280 DOING THIS. 523 00:23:10,280 --> 00:23:13,400 >> JUST TO CONFIRM, CARL, YOU 524 00:23:13,400 --> 00:23:16,120 DID SAY EVERY NETWORK UNDER THE 525 00:23:16,120 --> 00:23:17,840 DIVISION OF AIDS WILL BE 526 00:23:17,840 --> 00:23:19,520 INVOLVED WITH DEVELOPING OR 527 00:23:19,520 --> 00:23:23,040 ADHERING TO OUR REASSESSING 528 00:23:23,040 --> 00:23:25,920 THEIR ACCESSIBILITY AND 529 00:23:25,920 --> 00:23:26,720 INCLUSION PRACTICES? 530 00:23:26,720 --> 00:23:27,720 >> YES. 531 00:23:27,720 --> 00:23:29,120 >> OK. 532 00:23:29,120 --> 00:23:31,320 >> I HAVE A NOTE IN THE CHAT 533 00:23:31,320 --> 00:23:33,360 THAT IT SEEMS LIKE MAYBE ONLY 534 00:23:33,360 --> 00:23:34,840 ACTG IS DOING IT TO START AND 535 00:23:34,840 --> 00:23:37,120 THE OTHER ISSUE IS THAT THE 536 00:23:37,120 --> 00:23:41,800 REPRESENTATIVE STUDIES RUBRIC IS 537 00:23:41,800 --> 00:23:47,080 GOING TO PUBLISH THEIR FINDINGS 538 00:23:47,080 --> 00:23:48,400 BUT OUR GOAL IS TO HAVE IT MOVED 539 00:23:48,400 --> 00:23:49,920 TO EVERY NETWORK. 540 00:23:49,920 --> 00:23:50,440 YES, MELISSA. 541 00:23:50,440 --> 00:23:53,840 >> THANK YOU. 542 00:23:53,840 --> 00:23:59,400 >> MONICA -- 543 00:23:59,400 --> 00:24:02,760 >> THE PROGRAMS HAVE BEEN 544 00:24:02,760 --> 00:24:04,520 AMAZING AND I REALLY WANTED TO 545 00:24:04,520 --> 00:24:06,560 THANK YOU ALL FOR SUPPORTING IT 546 00:24:06,560 --> 00:24:08,720 BECAUSE CFAR'S WERE NEVER ABLE 547 00:24:08,720 --> 00:24:10,520 TO SUPPORT PEOPLE FROM 548 00:24:10,520 --> 00:24:14,680 UNDERGRADUATE OR MASTER-LEVEL 549 00:24:14,680 --> 00:24:17,840 PROGRAMS AND IT IS STARTING THE 550 00:24:17,840 --> 00:24:18,920 PIPELINE EARLIER AND WE HAVE ONE 551 00:24:18,920 --> 00:24:23,040 OF THESE AND IT IS GOING SO 552 00:24:23,040 --> 00:24:27,640 WHEREON OCTOBER AGENT, FIFTH. 553 00:24:27,640 --> 00:24:29,560 I WANT TO ASK IF DISADVANTAGED 554 00:24:29,560 --> 00:24:32,320 STUDENTS FROM SOCIOECONOMIC 555 00:24:32,320 --> 00:24:33,720 DISADVANTAGED BEYOND RACIAL AND 556 00:24:33,720 --> 00:24:35,880 ETHNIC AND MINORITY STATUS FITS 557 00:24:35,880 --> 00:24:39,960 INTO OUR MISSION IN THE CFAR 558 00:24:39,960 --> 00:24:41,400 PROGRAMS BECAUSE WHEN YOU GET TO 559 00:24:41,400 --> 00:24:43,720 A K, THE SOCIOECONOMIC 560 00:24:43,720 --> 00:24:45,400 DISADVANTAGES DOESN'T COUNT AS 561 00:24:45,400 --> 00:24:51,200 MUCH AS BEING IN THE URM 562 00:24:51,200 --> 00:24:53,440 CATEGORY. 563 00:24:53,440 --> 00:24:55,520 >> AT THE NIH LEVEL WE 564 00:24:55,520 --> 00:24:57,040 CATEGORIZE IT AS A DISADVANTAGED 565 00:24:57,040 --> 00:24:58,320 GROUP AS WELL AND I THINK WE 566 00:24:58,320 --> 00:24:59,280 WILL CONTINUE TO DO SO. 567 00:24:59,280 --> 00:25:02,880 >> OK. 568 00:25:02,880 --> 00:25:05,000 THANK YOU. 569 00:25:05,000 --> 00:25:06,080 AUDRY MAKES THE IMPORTANT POINT 570 00:25:06,080 --> 00:25:07,480 IN THE CHAT IT WOULD BE GREAT TO 571 00:25:07,480 --> 00:25:10,120 THINK ABOUT CHECKLISTS FOR DEIA 572 00:25:10,120 --> 00:25:12,760 AND OTHERS AND OTHER GRANT 573 00:25:12,760 --> 00:25:13,080 SUBMISSIONS. 574 00:25:13,080 --> 00:25:16,240 >> THAT IS OUTSIDE OF OUR 575 00:25:16,240 --> 00:25:20,080 PURVIEW BECAUSE IT'S A NIH 576 00:25:20,080 --> 00:25:21,800 POLICY ISSUE. 577 00:25:21,800 --> 00:25:24,240 >> WE CAN GENERATE IT FROM HERE 578 00:25:24,240 --> 00:25:24,880 AND MOVE -- 579 00:25:24,880 --> 00:25:27,160 >> YEAH. 580 00:25:27,160 --> 00:25:29,680 >> OK. 581 00:25:29,680 --> 00:25:30,440 >> I WOULD LIKE TO JUST SAY, WE 582 00:25:30,440 --> 00:25:33,360 HAVE BEEN FLYING UNDER THE RADAR 583 00:25:33,360 --> 00:25:36,200 DOING THESE THINGS, FOR A NUMBER 584 00:25:36,200 --> 00:25:37,880 OF YEARS AND I WOULD LIKE US TO 585 00:25:37,880 --> 00:25:40,320 BE ABLE TO MAKE SURE THAT WE CAN 586 00:25:40,320 --> 00:25:41,920 CONTINUE TO FLY. 587 00:25:41,920 --> 00:25:44,720 I THINK THAT'S OUR GOAL. 588 00:25:44,720 --> 00:25:48,360 >> FAIR ENOUGH. 589 00:25:48,360 --> 00:25:49,560 LET ME ASKED NOTE THAT IT'S 590 00:25:49,560 --> 00:25:51,720 GREAT THE THIRD ARM YOU 591 00:25:51,720 --> 00:25:53,840 MENTIONED IN A 5418 TO GET THAT 592 00:25:53,840 --> 00:25:54,800 INFORMATION FROM THE VERY 593 00:25:54,800 --> 00:25:56,200 BEGINNING IT'S A MAJOR STEP 594 00:25:56,200 --> 00:26:06,680 FORWARD I THINK WITH THE TRIAL. 595 00:26:06,680 --> 00:26:07,960 >> AGREED. 596 00:26:07,960 --> 00:26:09,360 WE CONTINUE NOW WITH THE OFFICE 597 00:26:09,360 --> 00:26:13,000 OF AIDS RESEARCH OAR UPDATE ON 598 00:26:13,000 --> 00:26:14,640 WOMEN'S HEALTH ON HIV ACTIVITIES 599 00:26:14,640 --> 00:26:20,240 IN FISCAL 22 Dr. LESLEY 600 00:26:20,240 --> 00:26:20,480 MARSHAL. 601 00:26:20,480 --> 00:26:21,320 >> CAN YOU HEAR ME? 602 00:26:21,320 --> 00:26:22,800 >> YES. 603 00:26:22,800 --> 00:26:25,600 >> GOOD AFTERNOON, I'M LESLEY 604 00:26:25,600 --> 00:26:26,520 MARSHAL SENIOR SCIENCE ADVISER 605 00:26:26,520 --> 00:26:28,160 FOR WOMEN'S HEALTH AND BIDE OWE 606 00:26:28,160 --> 00:26:29,440 MEDICAL PREVENTION IN THE NIH 607 00:26:29,440 --> 00:26:32,560 OFFICE OF AIDS RESEARCH COMMONLY 608 00:26:32,560 --> 00:26:34,480 REFERRED TO AS NIHIR AND I'M 609 00:26:34,480 --> 00:26:35,480 PLEASED TO BE HERE TODAY TO 610 00:26:35,480 --> 00:26:40,080 PROVIDE YOU AN UPDATE ON NIH/IRI 611 00:26:40,080 --> 00:26:41,640 IN FISCAL YEAR 22 AT THE 612 00:26:41,640 --> 00:26:43,280 INTERSECTION OF WOMEN'S HEALTH 613 00:26:43,280 --> 00:26:48,080 AND HIV/AIDS RESEARCH. 614 00:26:48,080 --> 00:26:49,520 TODAY I'LL PRESENT SOME METRICS 615 00:26:49,520 --> 00:26:51,160 THAT REFLECT TO HIV PANDEMIC AS 616 00:26:51,160 --> 00:26:53,400 IT RELATES TO WOMEN. 617 00:26:53,400 --> 00:26:56,200 AND AN UPDATE ON IMPORTANT NEW 618 00:26:56,200 --> 00:26:57,640 WOMEN'S HEALTH ACTIVITIES AT 619 00:26:57,640 --> 00:26:57,800 NIH. 620 00:26:57,800 --> 00:26:59,800 WE WILL THEN REVIEW AN IMPORTANT 621 00:26:59,800 --> 00:27:01,320 TOPIC, WHAT IS NIH DOING TO 622 00:27:01,320 --> 00:27:03,120 STRENGTHEN THE POSITION OF WOMEN 623 00:27:03,120 --> 00:27:09,320 WITHIN THE HEALTH RESEARCH 624 00:27:09,320 --> 00:27:10,720 WORKFORCE. 625 00:27:10,720 --> 00:27:12,160 IN 2021, 20 MILLION WOMEN AND 626 00:27:12,160 --> 00:27:14,760 GIRLS WERE LIVING WITH HIV. 627 00:27:14,760 --> 00:27:16,800 ABOUT 54% OF ALL PEOPLE LIVING 628 00:27:16,800 --> 00:27:18,120 WITH HIV. 629 00:27:18,120 --> 00:27:20,120 HIV PREVALENCE AMONGST 630 00:27:20,120 --> 00:27:22,080 TRANSGENDER WOMEN IS HIGH WITH A 631 00:27:22,080 --> 00:27:26,360 14-FOLD GREATER RISK OF HIV 632 00:27:26,360 --> 00:27:28,680 ACQUISITION THAN ADULT CISGENDER 633 00:27:28,680 --> 00:27:29,480 WOMEN. 634 00:27:29,480 --> 00:27:30,560 ADOLESCENT GIRLS AND YOUNG WOMEN 635 00:27:30,560 --> 00:27:32,680 WERE TWICE AS LIKELY AS THEIR 636 00:27:32,680 --> 00:27:35,400 PEERS TO BE LIVING WITH HIV AND 637 00:27:35,400 --> 00:27:37,680 SUB SA HER ENTER AFRICA AND 638 00:27:37,680 --> 00:27:39,720 WOMEN LIVING WITH HIV ARE AGING. 639 00:27:39,720 --> 00:27:42,840 AND AGING WOMEN REMAIN AT RISK 640 00:27:42,840 --> 00:27:44,400 FOR HIV. 641 00:27:44,400 --> 00:27:46,000 CDC ANALYSIS REPORTS THAT HIV IS 642 00:27:46,000 --> 00:27:48,240 ON THE RISE AMONG WOMEN 55 YEARS 643 00:27:48,240 --> 00:27:50,600 AND OLDER IN THE U.S. AND IT 644 00:27:50,600 --> 00:27:52,720 HIGHLIGHTS A FUNDAMENTAL GAP IN 645 00:27:52,720 --> 00:27:54,280 UNDERSTANDING ABOUT PREVENTION 646 00:27:54,280 --> 00:27:56,280 AND CONSIDERATIONS ACROSS 647 00:27:56,280 --> 00:28:00,040 LIFESPAN INCLUDING MONKEYPOX. 648 00:28:00,040 --> 00:28:01,480 REGARDING HIV INCIDENTS HALF OF 649 00:28:01,480 --> 00:28:03,560 ALL OF ALL NEW INFECTIONS WERE 650 00:28:03,560 --> 00:28:07,400 AMONG WOMEN BUT THIS IS HEAVILY 651 00:28:07,400 --> 00:28:10,000 RATED AMONGST YOUNG WOMEN IN 652 00:28:10,000 --> 00:28:14,680 EASTERN HALF ACH AVENUE RICKAL. 653 00:28:14,680 --> 00:28:16,480 INCLUDING EXCLUSION FROM 654 00:28:16,480 --> 00:28:17,680 ECONOMIC OPPORTUNITIES, LACK OF 655 00:28:17,680 --> 00:28:19,440 ACCESS TO SECONDARY SCHOOLING 656 00:28:19,440 --> 00:28:21,840 AND GENDER-BASED VIOLENCE. 657 00:28:21,840 --> 00:28:22,880 WOMEN AND GIRLS EXPERIENCE 658 00:28:22,880 --> 00:28:24,400 PHYSICAL OR SEXUAL INTIMATE 659 00:28:24,400 --> 00:28:26,480 PARTNER VIOLENCE ARE 1.5 TIMES 660 00:28:26,480 --> 00:28:32,160 MORE LIKELY TO ACQUIRE HIV. 661 00:28:32,160 --> 00:28:35,200 IMPORTANTLY, RACE OWN 662 00:28:35,200 --> 00:28:36,880 DISCRIMINATION AND HIV STIGMA ON 663 00:28:36,880 --> 00:28:39,760 BARRIERS FOR WOMEN ACCESSING 664 00:28:39,760 --> 00:28:42,600 PREP. 665 00:28:42,600 --> 00:28:44,280 WOMEN AT RISK FOR HIV WILL 666 00:28:44,280 --> 00:28:46,080 SELF-IDENTIFY OR BE IDENTIFIED 667 00:28:46,080 --> 00:28:47,440 BY THEIR HEALTHCARE PROVIDERS 668 00:28:47,440 --> 00:28:48,840 AND TRANSGENDER WOMEN HAVE 669 00:28:48,840 --> 00:28:49,960 LIMITED ENGAGEMENT WITH 670 00:28:49,960 --> 00:28:53,920 HEALTHCARE SERVICES FURTHER 671 00:28:53,920 --> 00:28:56,680 LIMITING EQUITABLE ACCESS TO 672 00:28:56,680 --> 00:28:57,040 PREP. 673 00:28:57,040 --> 00:29:00,000 IN THE U.S., CDC REPORTS THAT 674 00:29:00,000 --> 00:29:02,960 ABOUT 18% OF NEW HIV INFECTIONS 675 00:29:02,960 --> 00:29:06,320 IN 2019 WERE AMONG WOMEN AND 23% 676 00:29:06,320 --> 00:29:09,000 OF ALL PERSONS WITH HIV IN THE 677 00:29:09,000 --> 00:29:10,280 U.S. ARE WOMEN. 678 00:29:10,280 --> 00:29:11,720 PROGRESS TOWARDS EPIDEMIC 679 00:29:11,720 --> 00:29:13,400 CONTROL TARGETS ARE BETTER AMONG 680 00:29:13,400 --> 00:29:15,200 WOMEN OVER ALL ACROSS THE 681 00:29:15,200 --> 00:29:16,480 CASCADE FROM OUR CONSIDERABLY 682 00:29:16,480 --> 00:29:20,120 SOME OPTIMAL FOR RESELECTION 683 00:29:20,120 --> 00:29:22,120 TENSION AND CARE MAKING ON BOARD 684 00:29:22,120 --> 00:29:23,040 TRANSMISSION INEVITABLE. 685 00:29:23,040 --> 00:29:26,480 NEXT SLIDE, PLEASE. 686 00:29:26,480 --> 00:29:28,320 AS HIV EFFECTS GIRLS AND WOMEN 687 00:29:28,320 --> 00:29:30,400 DIFFERENTLY A CROSS THE 688 00:29:30,400 --> 00:29:32,760 LIFESPAN, THE NIH-HIV RESEARCH 689 00:29:32,760 --> 00:29:34,760 AGENDA FOR WOMEN SHOULD BE 690 00:29:34,760 --> 00:29:36,080 TAILORED APPROPRIATELY. 691 00:29:36,080 --> 00:29:37,840 KEY FOCAL AREAS INCLUDE HIV 692 00:29:37,840 --> 00:29:40,000 DURING PREGNANCY AND LACTATION, 693 00:29:40,000 --> 00:29:41,360 EARLY CHILDHOOD CONSEQUENCES OF 694 00:29:41,360 --> 00:29:44,680 HIV EXPOSURE, HIV IN MENOPAUSE, 695 00:29:44,680 --> 00:29:47,760 THE INTERSECTION OF HIV AND 696 00:29:47,760 --> 00:29:48,920 CO-MORBIDITY, IMPLEMENTATION AND 697 00:29:48,920 --> 00:29:50,840 RESEARCH PARTICULARLY ON 698 00:29:50,840 --> 00:29:51,560 PREVENTION, TREATMENT AND 699 00:29:51,560 --> 00:29:53,240 MATERNAL MORBIDITY AND 700 00:29:53,240 --> 00:29:57,320 MORTALITY, GENDER AFFIRMING AND 701 00:29:57,320 --> 00:29:58,600 (INAUDIBLE) HIV CARE FOR 702 00:29:58,600 --> 00:29:59,400 TRANSGENDER PEOPLE AND THE ROLE 703 00:29:59,400 --> 00:30:01,480 OF SEX AND GENDER AND EFFICACY 704 00:30:01,480 --> 00:30:04,280 OF HIV INTERVENTIONS INCLUDING 705 00:30:04,280 --> 00:30:05,840 PREVENTION, TREATMENT AND CURE. 706 00:30:05,840 --> 00:30:16,160 NEXT SLIDE, PLEASE. 707 00:30:41,720 --> 00:30:44,840 -- WITH SCIENCE, HIV TICK MA AND 708 00:30:44,840 --> 00:30:46,160 DISCRIMINATION, CURE, VACCINES 709 00:30:46,160 --> 00:30:51,360 DEVELOPMENT AND MORE AND AS WE 710 00:30:51,360 --> 00:30:52,920 SHIFT TO RESEARCH CONSIDERATIONS 711 00:30:52,920 --> 00:30:54,040 WE'LL BEGIN WITH THE NIH VISION 712 00:30:54,040 --> 00:30:55,600 FOR WOMEN'S HEALTH RESEARCH AND 713 00:30:55,600 --> 00:30:59,360 HOW IT RELATES TO HIV/AIDS. 714 00:30:59,360 --> 00:31:00,880 THE NIH VISION FOR WOMEN'S 715 00:31:00,880 --> 00:31:05,280 HEALTH INCLUDES THREE 716 00:31:05,280 --> 00:31:09,160 PRINCIPLES, INNS INAUGUR INTEGRF 717 00:31:09,160 --> 00:31:10,720 WOMEN'S HEALTH RESEARCH AND 718 00:31:10,720 --> 00:31:12,600 CONSIDER FOR HIV AND CARE WOMEN 719 00:31:12,600 --> 00:31:13,920 SCIENCE CAREER REACHING THEIR 720 00:31:13,920 --> 00:31:16,360 FULL POTENTIAL. 721 00:31:16,360 --> 00:31:18,040 RESEARCH TO IMPROVE WOMEN'S 722 00:31:18,040 --> 00:31:20,560 HEALTH REQUIRES A COMPREHENSIVE 723 00:31:20,560 --> 00:31:21,640 CONSIDERATION OF THE MANY 724 00:31:21,640 --> 00:31:24,360 FACTORS SUCH AS GENDER, AND SEX, 725 00:31:24,360 --> 00:31:26,000 RACE, AND ETHNICITY JUST TO 726 00:31:26,000 --> 00:31:29,800 MENTION A FEW. 727 00:31:29,800 --> 00:31:31,600 THIS FRAMEWORK CAPTURES THESE 728 00:31:31,600 --> 00:31:33,400 INTERNAL AND EXTERNAL FACTORS 729 00:31:33,400 --> 00:31:38,040 AND THEIR INTEGRATION As COULD S 730 00:31:38,040 --> 00:31:39,000 THE LIFE FORCE. 731 00:31:39,000 --> 00:31:42,000 THE STRUCTURE OF NIH AND MAXIMUM 732 00:31:42,000 --> 00:31:43,680 IMPACT OF HIV RESEARCH FOR WOMEN 733 00:31:43,680 --> 00:31:44,480 AND GIRLS. 734 00:31:44,480 --> 00:31:46,520 BOTH THE NIH IR AND THE OFFICE 735 00:31:46,520 --> 00:31:48,320 OF RESEARCH IN WOMEN'S HEALTH 736 00:31:48,320 --> 00:31:49,760 SIT WITHIN THE OFFICE OF THE 737 00:31:49,760 --> 00:31:52,720 DIRECTOR AND THESE OFFICES 738 00:31:52,720 --> 00:31:55,120 COLLABORATE TOGETHER AND ACROSS 739 00:31:55,120 --> 00:31:56,880 OTHER NIH CENTERS AND OFFICES TO 740 00:31:56,880 --> 00:31:58,840 ENSURE SYNERGY AND ADVANCEMENT 741 00:31:58,840 --> 00:32:00,760 OF RESEARCH TOPICS OF INTEREST 742 00:32:00,760 --> 00:32:03,240 FOR WOMEN LIVING WITH AND AT 743 00:32:03,240 --> 00:32:05,880 RISK FOR HIV. 744 00:32:05,880 --> 00:32:08,360 WE'RE NOW GOING TO EXPLORE SOME 745 00:32:08,360 --> 00:32:09,440 IMPORTANT WORK ON DRAWING AT THE 746 00:32:09,440 --> 00:32:10,480 INTERSECTION OF WOMEN'S HEALTH 747 00:32:10,480 --> 00:32:14,480 AND HIV AT THE NIH. 748 00:32:14,480 --> 00:32:16,680 NEXT SLIDE, IN 2021, CONGRESS 749 00:32:16,680 --> 00:32:18,600 REQUESTED AN UPDATE ON AND 750 00:32:18,600 --> 00:32:19,920 FURTHER INVESTMENT IN NIH 751 00:32:19,920 --> 00:32:21,320 EFFORTS RELATED TO WOMEN'S 752 00:32:21,320 --> 00:32:22,360 HEALTH RESEARCH. 753 00:32:22,360 --> 00:32:24,480 WITH A SPECIFIC EMPHASIS ON 754 00:32:24,480 --> 00:32:27,560 RISING MATERNAL MORBIDITY AND 755 00:32:27,560 --> 00:32:28,720 MORTALITY RATES AND RISING RATES 756 00:32:28,720 --> 00:32:30,800 OF CHRONIC, DEBILITATING 757 00:32:30,800 --> 00:32:32,480 CONDITIONS IN WOMEN. 758 00:32:32,480 --> 00:32:34,480 NIH IS ON THE SUB LINES OF THESE 759 00:32:34,480 --> 00:32:38,480 EFFORTS AS DESCRIBED IN THE 760 00:32:38,480 --> 00:32:39,520 COMING SLIDES. 761 00:32:39,520 --> 00:32:41,000 MATERNAL MORBIDITY AND MORTALITY 762 00:32:41,000 --> 00:32:43,240 IS A PUBLIC-HEALTH CRISIS IN THE 763 00:32:43,240 --> 00:32:44,160 UNITED STATES. 764 00:32:44,160 --> 00:32:47,480 WITH AN ESTIMATED 6/10 MATERNAL 765 00:32:47,480 --> 00:32:49,520 DEATHS BEING PREVENTABLE. 766 00:32:49,520 --> 00:32:51,880 DURING 2011 TO 2015 THE U.S. HAD 767 00:32:51,880 --> 00:32:54,640 NEARLY TWICE THE LIVE BIRTH 768 00:32:54,640 --> 00:32:55,840 MATERNAL MORTALITY RATE IN 769 00:32:55,840 --> 00:32:57,840 CANADA AND THE UNITED KINGDOM. 770 00:32:57,840 --> 00:33:00,720 THIS IS EVEN MORE PRONOUNCED 771 00:33:00,720 --> 00:33:01,760 AMONGST WOMEN OF COLOR. 772 00:33:01,760 --> 00:33:03,680 THESE RACIAL AND ETHNIC 773 00:33:03,680 --> 00:33:05,160 DISPARITIES ARE INFLUENCED BY 774 00:33:05,160 --> 00:33:07,200 STRUCTURAL RACISM AND IMPLICIT 775 00:33:07,200 --> 00:33:09,000 BIAS AND RACIALLY BIASED 776 00:33:09,000 --> 00:33:11,920 POLICIES AND PRACTICES. 777 00:33:11,920 --> 00:33:13,960 NEITHER EDUCATION NOR HIGHER 778 00:33:13,960 --> 00:33:15,640 SOCIOECONOMIC STATUS MITIGATE 779 00:33:15,640 --> 00:33:20,360 THE RISKS. 780 00:33:20,360 --> 00:33:23,520 GLOBALLY IN 2021, THERE WERE 781 00:33:23,520 --> 00:33:24,960 1.3 MILLION PREGNANT PEOPLE 782 00:33:24,960 --> 00:33:27,800 LIVING WITH HIV OF WHICH AN 783 00:33:27,800 --> 00:33:31,480 ESTIMATED 81% RECEIVED ANTI 784 00:33:31,480 --> 00:33:35,360 RETRO VIRAL THERAPY TO PREVENT 785 00:33:35,360 --> 00:33:36,080 TRANSMISSION. 786 00:33:36,080 --> 00:33:37,880 ESTIMATING MATERNAL MORTALITY IS 787 00:33:37,880 --> 00:33:38,800 CHALLENGE BECAUSE IT CAN BE 788 00:33:38,800 --> 00:33:40,440 EFFECTED WITH CHANGING POLICIES. 789 00:33:40,440 --> 00:33:42,560 FOR MOST RECENT REPORT FOUND THE 790 00:33:42,560 --> 00:33:45,000 W.H.O. IN 2017 INDICATES THAT 791 00:33:45,000 --> 00:33:47,440 1.2% OF MATERNAL DEATHS GLOBALLY 792 00:33:47,440 --> 00:33:51,760 ARE ESTIMATED TO BE HIV-RELATED. 793 00:33:51,760 --> 00:33:54,040 AND BECAUSE OF CO-MORBIDITY, 794 00:33:54,040 --> 00:33:55,760 PREGNANT WOMEN WITH HIV ARE 795 00:33:55,760 --> 00:33:59,720 LINKED WITH A TWO TO 10 FOLD 796 00:33:59,720 --> 00:34:01,520 INCREASED RISK OF HIV. 797 00:34:01,520 --> 00:34:02,760 OR OF DEATH. 798 00:34:02,760 --> 00:34:03,000 SORRY. 799 00:34:03,000 --> 00:34:08,360 NEXT SLIDE, PLEASE. 800 00:34:08,360 --> 00:34:11,160 IN 2019, NIH INITIATED MATERNAL 801 00:34:11,160 --> 00:34:12,800 MORBIDITY AND MATERNITY EFFORTS 802 00:34:12,800 --> 00:34:14,360 ACROSS THE ORGANIZATION THROUGH 803 00:34:14,360 --> 00:34:16,600 FORMATION OF A ADVISORY CABINET 804 00:34:16,600 --> 00:34:18,880 WITH SEN NER NIH LEADERS AND A 805 00:34:18,880 --> 00:34:20,280 TASK FORCE WITH KEY SUBJECT 806 00:34:20,280 --> 00:34:22,040 MATTER EXPERTS FROM ALL THE 807 00:34:22,040 --> 00:34:25,120 INSTITUTE CENTERS AND OFFICES. 808 00:34:25,120 --> 00:34:27,040 THE NIH RAR DIRECTOR IS A MEMBER 809 00:34:27,040 --> 00:34:28,800 OF THE ADVISORY CABINET AND 810 00:34:28,800 --> 00:34:32,600 MULTIPLE ADVISERS FROM NIH RAR 811 00:34:32,600 --> 00:34:33,680 SCIENCE TEAM SERVE AS MEMBERS OF 812 00:34:33,680 --> 00:34:35,720 THE TASK FORCE. 813 00:34:35,720 --> 00:34:37,120 THE MATERNAL HEALTH AND 814 00:34:37,120 --> 00:34:39,240 PREGNANCY OUTCOMES DIVISION FOR 815 00:34:39,240 --> 00:34:41,000 EVERYONE OR THE IMPROVE 816 00:34:41,000 --> 00:34:43,160 INITIATIVE, WAS THE FIRST 817 00:34:43,160 --> 00:34:44,080 DELIVERED ON THIS FORCE. 818 00:34:44,080 --> 00:34:46,480 IT SUPPORTS RESEARCH FOCUSED ON 819 00:34:46,480 --> 00:34:48,400 REDUCING PREVENTABLE CAUSES OF 820 00:34:48,400 --> 00:34:50,800 MATERNAL DEATHS AND IMPROVING 821 00:34:50,800 --> 00:34:52,280 HEALTH FOR WOMEN BEFORE, DURING 822 00:34:52,280 --> 00:34:54,240 AND AFTER DELIVERY. 823 00:34:54,240 --> 00:34:57,840 AND FISCAL YEAR '22, IMPROVE 824 00:34:57,840 --> 00:34:58,920 RECEIVED $30 MILLION FROM 825 00:34:58,920 --> 00:34:59,680 CONGRESS. 826 00:34:59,680 --> 00:35:01,680 THE ADVISORY CABINET AND THE 827 00:35:01,680 --> 00:35:03,640 TASK MORSE ARE WORKING ON 828 00:35:03,640 --> 00:35:05,760 MECHANISMS TO MAXIMIZE THIS 829 00:35:05,760 --> 00:35:06,920 INVESTMENT IMPACT. 830 00:35:06,920 --> 00:35:08,320 KEY ACTIVITIES OF THE TASK FORCE 831 00:35:08,320 --> 00:35:11,120 ARE NOTED HERE. 832 00:35:11,120 --> 00:35:12,960 I WON'T REVIEW THEM TODAY IN 833 00:35:12,960 --> 00:35:14,840 DETAIL BUT I ENCOURAGE YOU TO 834 00:35:14,840 --> 00:35:15,760 REVIEW THESE OPPORTUNITIES AND 835 00:35:15,760 --> 00:35:19,920 TO SHARE WITHIN YOUR NETWORKS. 836 00:35:19,920 --> 00:35:21,520 WE WILL NOW EXPLORE CRITICAL 837 00:35:21,520 --> 00:35:24,000 TOPICS WHICH IS REPRESENTATION 838 00:35:24,000 --> 00:35:30,440 OF WOMEN IN THE BIOMEDICAL 839 00:35:30,440 --> 00:35:30,680 WORKFORCE. 840 00:35:30,680 --> 00:35:32,280 THEY HAVE THE BARRIERS THAT 841 00:35:32,280 --> 00:35:33,240 WOMEN HAVE EXPERIENCING FOR 842 00:35:33,240 --> 00:35:34,800 DECADES IN THE STEM FIELDS. 843 00:35:34,800 --> 00:35:37,040 FOR EXAMPLE, WOMEN IN ACADEMIA 844 00:35:37,040 --> 00:35:39,520 FACE MORE SEVERE VERSIONS OF 845 00:35:39,520 --> 00:35:41,800 LONGSTANDING GENDER GAPS, CAREER 846 00:35:41,800 --> 00:35:43,680 INTERRUPTIONS CAN HAMPER WOMEN'S 847 00:35:43,680 --> 00:35:46,000 ABILITY TO TENURE, AND COVID-19 848 00:35:46,000 --> 00:35:47,960 HAS HAD A DEVASTATING IMPACT ON 849 00:35:47,960 --> 00:35:49,960 OUR CAREER INVESTIGATORS. 850 00:35:49,960 --> 00:35:51,840 WOMEN ARE MORE LIKELY TO EXIT 851 00:35:51,840 --> 00:35:54,680 THE WORKFORCE BECAUSE OF 852 00:35:54,680 --> 00:35:55,600 PANDEMIC-RELATED HOUSEHOLD 853 00:35:55,600 --> 00:35:57,000 RESPONSIBILITY AND WOMEN'S 854 00:35:57,000 --> 00:35:58,160 DEPARTURES DO EFFECT THE 855 00:35:58,160 --> 00:36:02,680 DIRECTION OF RESEARCH. 856 00:36:02,680 --> 00:36:04,320 NIH IS WORKING TO REMOVE 857 00:36:04,320 --> 00:36:05,480 BARRIERS FOR RECOMMEND IN 858 00:36:05,480 --> 00:36:07,240 RESEARCH CAREERS BY INCREASING 859 00:36:07,240 --> 00:36:09,960 FUNDING FOR RESEARCH WOMEN WITH 860 00:36:09,960 --> 00:36:10,600 HIV/AIDS. 861 00:36:10,600 --> 00:36:11,480 TAKING INTO CONSIDERATION 862 00:36:11,480 --> 00:36:14,640 CHILDCARE COSTS FOR IN AUD 863 00:36:14,640 --> 00:36:15,920 INCREASING DIVERSITY IN THE 864 00:36:15,920 --> 00:36:17,120 FEMALE WORKFORCE BY THE 865 00:36:17,120 --> 00:36:18,720 DIFFERENT MECHANISMS LISTED HERE 866 00:36:18,720 --> 00:36:21,240 AND PROVIDING SUPPLEMENTS FOR 867 00:36:21,240 --> 00:36:26,160 COVID-19 RESEARCH DISRUPTIONS. 868 00:36:26,160 --> 00:36:28,400 THE WOMEN'S HEALTH RESEARCH BY 869 00:36:28,400 --> 00:36:32,760 ANNUAL REPORT FOR FISCAL YEARS 870 00:36:32,760 --> 00:36:33,840 2019-2020, PRESENTS INFORMATION 871 00:36:33,840 --> 00:36:36,040 ABOUT SEX, RACIAL, AND ETHNIC 872 00:36:36,040 --> 00:36:39,000 BREAKDOWN OF THE NIH WORKFORCE 873 00:36:39,000 --> 00:36:40,080 AND GRANTEES. 874 00:36:40,080 --> 00:36:42,160 OVER ALL, WOMEN'S GRANT 875 00:36:42,160 --> 00:36:43,120 APPLICATION OUTCOMES HAVE 876 00:36:43,120 --> 00:36:47,720 IMPROVED IN RECENT YEARS. 877 00:36:47,720 --> 00:36:49,200 APPLICANTS WHO ARE FEMALES FROM 878 00:36:49,200 --> 00:36:50,880 UNDER REPRESENTED RACIAL AND 879 00:36:50,880 --> 00:36:52,080 ETHNIC GROUPS WERE WELL ABOVE 880 00:36:52,080 --> 00:36:54,000 THOSE OF ALL FEMALE APPLICANTS 881 00:36:54,000 --> 00:36:55,360 IN GENERAL AND AFRICAN AMERICAN 882 00:36:55,360 --> 00:36:57,960 FEMALE INVESTIGATORS HAVE THE 883 00:36:57,960 --> 00:36:59,640 LOWEST SUCCESS RATES AMONG ALL 884 00:36:59,640 --> 00:37:01,120 FEMALES FROM UNDER REPRESENTED 885 00:37:01,120 --> 00:37:05,280 RACIAL AND ETHNIC GROUPS. 886 00:37:05,280 --> 00:37:07,800 AND A NEW PUBLICATION FROM WOMEN 887 00:37:07,800 --> 00:37:08,920 LEADERS AT NIH DESCRIBES EFFORTS 888 00:37:08,920 --> 00:37:10,880 TO LEAD BY EXAMPLE THROUGH 889 00:37:10,880 --> 00:37:12,960 ESTABLISHMENT OF PRINCIPLES FOR 890 00:37:12,960 --> 00:37:19,600 IN CONCLUSIVE EX LENS EXCELLENH 891 00:37:19,600 --> 00:37:21,160 ENHANCED FLEXIBILITY OPTIONS, 892 00:37:21,160 --> 00:37:23,640 CREATING CULTURES OF INCLUSION, 893 00:37:23,640 --> 00:37:26,600 REQUIRES LEADERSHIP SUPPORT, 894 00:37:26,600 --> 00:37:27,800 ACTION-ORIENTED ACCOUNTABILITY 895 00:37:27,800 --> 00:37:32,000 AND RESEARCH INTERVENTIONS ARE 896 00:37:32,000 --> 00:37:34,160 BEST PRACTICES. 897 00:37:34,160 --> 00:37:35,800 THE NIH AND WOMEN RESEARCH 898 00:37:35,800 --> 00:37:37,760 PORTFOLIO PRINCIPLES ARE UNDER 899 00:37:37,760 --> 00:37:39,400 SCORED IN NIH UNITE INITIATIVE 900 00:37:39,400 --> 00:37:43,240 AND PROACTIVE IMPLEMENTATION OF 901 00:37:43,240 --> 00:37:44,440 DEIA PRINCIPLES. 902 00:37:44,440 --> 00:37:46,680 WE'RE COMMITTED TO REDUCING 903 00:37:46,680 --> 00:37:48,600 BARRIERS FOR RACIAL EQUITY AND 904 00:37:48,600 --> 00:37:50,680 THE HIV-AIDS RESEARCH WORKFORCE 905 00:37:50,680 --> 00:37:53,200 BY APPLYING A CRITICAL LENS TO 906 00:37:53,200 --> 00:37:54,320 IDENTIFY OPPORTUNITIES AND 907 00:37:54,320 --> 00:37:56,120 IMPLEMENT STRATEGIES TO INCREASE 908 00:37:56,120 --> 00:37:57,880 INCLUSIVITY AND DIVERSITY IN THE 909 00:37:57,880 --> 00:38:00,280 HIV AIDS RESEARCH ENTERPRISE. 910 00:38:00,280 --> 00:38:02,960 AND TO PROVIDE PLATFORM FOR I DO 911 00:38:02,960 --> 00:38:05,800 VERSE VOICES ACROSS THE HIV-AIDS 912 00:38:05,800 --> 00:38:08,320 RESEARCH CONTINUUM. 913 00:38:08,320 --> 00:38:10,000 IN CLOSING, I WANT TO THANK YOU 914 00:38:10,000 --> 00:38:11,560 FOR THE CHANCE TO SHARE THIS 915 00:38:11,560 --> 00:38:13,200 INFORMATION WITH YOU TODAY. 916 00:38:13,200 --> 00:38:14,720 THE NIH IS COMMITTED TO 917 00:38:14,720 --> 00:38:15,800 ADVANCING THE HEALTH AND 918 00:38:15,800 --> 00:38:17,120 WELLBEING OF ALL WOMEN AND WE 919 00:38:17,120 --> 00:38:19,080 WELCOME YOUR THOUGHTS AND 920 00:38:19,080 --> 00:38:19,520 SUGGESTIONS. 921 00:38:19,520 --> 00:38:21,240 THERE ARE MANY WAYS TO STAY 922 00:38:21,240 --> 00:38:27,280 CONNECTED AND LEAVING FOR US ON 923 00:38:27,280 --> 00:38:37,520 SOCIAL MEDIA. 924 00:38:38,960 --> 00:38:40,200 >> THANK YOU FOR THAT REPORT. 925 00:38:40,200 --> 00:38:41,800 WE HAVE A COUPLE OF MINUTES FOR 926 00:38:41,800 --> 00:38:43,200 QUESTIONS. 927 00:38:43,200 --> 00:38:43,480 MELISSA -- 928 00:38:43,480 --> 00:38:45,680 >> THANK YOU FOR THAT 929 00:38:45,680 --> 00:38:47,440 PRESENTATION AND A VERY 930 00:38:47,440 --> 00:38:48,680 COMPREHENSIVE AND HELPFUL. 931 00:38:48,680 --> 00:38:50,440 I GUESS ONE OF THE THINGS THAT I 932 00:38:50,440 --> 00:38:51,400 LEARNED ABOUT AND HEARD ABOUT 933 00:38:51,400 --> 00:38:55,880 OVER THE YEARS IN THE PREVENTION 934 00:38:55,880 --> 00:38:57,560 ARENA IS THAT FOR WOMEN AND 935 00:38:57,560 --> 00:38:59,720 GIRLS AT RISK FOR HIV, MAY NOT 936 00:38:59,720 --> 00:39:03,320 FULLY RECOGNIZE OR BE AWARE OF 937 00:39:03,320 --> 00:39:05,280 THEIR RISK AND I FULLY 938 00:39:05,280 --> 00:39:06,760 APPRECIATE THAT IT EVEN EXISTS. 939 00:39:06,760 --> 00:39:08,720 SO THIS MAKES IT MORE DIFFICULT 940 00:39:08,720 --> 00:39:11,920 TO THEN BE PROACTIVE AND PURSUE 941 00:39:11,920 --> 00:39:13,840 POTENTIAL REMEDIES OR OPTIONS IN 942 00:39:13,840 --> 00:39:15,560 OUR PREVENTION TOOLBOX. 943 00:39:15,560 --> 00:39:16,520 ANY THOUGHTS ABOUT WORK BEING 944 00:39:16,520 --> 00:39:18,280 DONE IN THAT AREA? 945 00:39:18,280 --> 00:39:19,840 ABOUT RAISING AWARENESS AND 946 00:39:19,840 --> 00:39:20,840 HELPING WOMEN AND GIRLS 947 00:39:20,840 --> 00:39:23,440 RECOGNIZE THEIR RISK? 948 00:39:23,440 --> 00:39:25,320 >> I THINK THERE'S A LOT 6 949 00:39:25,320 --> 00:39:27,040 EFFORT BEING PUT INTO THIS AREA 950 00:39:27,040 --> 00:39:29,400 AND ESPECIALLY WITH THE ADVENT 951 00:39:29,400 --> 00:39:33,640 OF NEW INNOVATIVE LONG-ACTING 952 00:39:33,640 --> 00:39:34,040 PREVENTION. 953 00:39:34,040 --> 00:39:37,720 AND I'M HAPPY TO SEE THAT THE 954 00:39:37,720 --> 00:39:40,160 ORGANIZATIONS DEVELOPING THESE 955 00:39:40,160 --> 00:39:42,960 TECHNOLOGIES ARE COMMITTING TO 956 00:39:42,960 --> 00:39:47,760 EQUITABLE ACCESS AND TO 957 00:39:47,760 --> 00:39:48,840 INCORPORATING THAT INTO THEIR 958 00:39:48,840 --> 00:39:51,600 PRACTICE AND I WOULD DEFER TO 959 00:39:51,600 --> 00:39:54,040 CARL OR ANYONE ELSE AT NIAID TO 960 00:39:54,040 --> 00:39:55,040 DISCUSS ON GOING IMPLEMENTATION 961 00:39:55,040 --> 00:39:58,440 EFFORTS IN THIS AREA. 962 00:39:58,440 --> 00:40:00,920 >> I WOULD JUST SAY A QUICK 963 00:40:00,920 --> 00:40:02,680 WORD, WHY THIS WITH 27 964 00:40:02,680 --> 00:40:03,680 INSTITUTES AND CENTERS AT NIH, A 965 00:40:03,680 --> 00:40:05,400 LOT OF THE BEHAVIORAL AND SOCIAL 966 00:40:05,400 --> 00:40:09,200 SCIENCE WORK IS DONE IN 967 00:40:09,200 --> 00:40:10,600 PARTNERSHIP WITH NIAID BY THE 968 00:40:10,600 --> 00:40:14,040 NIMH AND THAT'S WHY DIANNE ROUSH 969 00:40:14,040 --> 00:40:16,280 AND HER TEAM ARE ACTUALLY 970 00:40:16,280 --> 00:40:17,360 CO-HOUSED WITHIN OUR 971 00:40:17,360 --> 00:40:18,320 ORGANIZATION BECAUSE IT IS IS 972 00:40:18,320 --> 00:40:19,840 THIS IMPORTANT INTERSECTION 973 00:40:19,840 --> 00:40:21,320 BETWEEN NOT JUST AVAILABILITY OF 974 00:40:21,320 --> 00:40:23,480 THE BIOMEDICAL INTERVENTION BUT 975 00:40:23,480 --> 00:40:24,760 ALSO HELPING TO MEET PEOPLE 976 00:40:24,760 --> 00:40:27,640 WHERE THEY LIVE SO THEY CAN 977 00:40:27,640 --> 00:40:29,480 UNDERSTAND THEIR RISK AND ALSO 978 00:40:29,480 --> 00:40:31,400 UNDERSTAND THE STIGMA HA THEY 979 00:40:31,400 --> 00:40:35,360 FEEL AND WHAT'S NEEDED TO HELP 980 00:40:35,360 --> 00:40:37,400 THEM DEVELOP THE CULTURAL 981 00:40:37,400 --> 00:40:40,080 COMPETENCY TO ACCESS THE 982 00:40:40,080 --> 00:40:41,880 RELATIVELY COMPLICATED 983 00:40:41,880 --> 00:40:46,440 BIOMEDICAL INTERVENTIONS. 984 00:40:46,440 --> 00:40:50,040 >> GREAT. 985 00:40:50,040 --> 00:40:53,200 WELL, THANK YOU Dr. MARSHAL, 986 00:40:53,200 --> 00:40:53,680 AGAIN. 987 00:40:53,680 --> 00:40:55,000 WHY DON'T WE MOVE. 988 00:40:55,000 --> 00:41:00,320 WE HAVE A NUMBER, WE HAVE SEVEN 989 00:41:00,320 --> 00:41:02,320 CONCEPTS WE ARE GOING TO GO 990 00:41:02,320 --> 00:41:03,040 THROUGH AND WE WILL START WITH 991 00:41:03,040 --> 00:41:06,720 THE BASIC SCIENCES PROGRAM. 992 00:41:06,720 --> 00:41:11,680 Dr. SANDERS AND Dr. NOVAK 993 00:41:11,680 --> 00:41:12,760 OPPORTUNITIES FOR HIV CURE 994 00:41:12,760 --> 00:41:15,320 STRATEGIES AT THE TIME OF OUR 995 00:41:15,320 --> 00:41:16,040 NIGMS INITIATION. 996 00:41:16,040 --> 00:41:16,520 Dr. SANDERS. 997 00:41:16,520 --> 00:41:18,120 >> HELLO. 998 00:41:18,120 --> 00:41:19,960 I WOULD LIKE TO PRESENT TO YOU 999 00:41:19,960 --> 00:41:22,920 THE CONCEPT OPPORTUNITIES FOR 1000 00:41:22,920 --> 00:41:24,960 HIV CURES STRATEGIES AT THE TIME 1001 00:41:24,960 --> 00:41:25,600 OF ART INITIATION. 1002 00:41:25,600 --> 00:41:28,600 THAT MY COLLEAGUELY A NOVAK AND 1003 00:41:28,600 --> 00:41:29,200 I DEVELOPED. 1004 00:41:29,200 --> 00:41:31,120 THIS FUNDING ANNOUNCED WAS 1005 00:41:31,120 --> 00:41:33,360 RECENTLY PUBLISHED AS A NOTICE 1006 00:41:33,360 --> 00:41:34,920 OF SPECIAL INTEREST AND BECAUSE 1007 00:41:34,920 --> 00:41:37,640 OF THE ENTHUSIASM WE RECEIVED SO 1008 00:41:37,640 --> 00:41:39,040 FAR, WE ARE NOT PRESENTING IT AT 1009 00:41:39,040 --> 00:41:41,080 THE AIDS RESEARCH ADVISORY 1010 00:41:41,080 --> 00:41:42,160 COMMITTEE MEETING. 1011 00:41:42,160 --> 00:41:44,400 NEXT SLIDE, PLEASE. 1012 00:41:44,400 --> 00:41:47,320 THE OBJECTIVE IS TO IDENTIFY NEW 1013 00:41:47,320 --> 00:41:48,720 OPPORTUNITIES FOR CURE 1014 00:41:48,720 --> 00:41:51,280 STRATEGIES NEAR THE TIME OF ART 1015 00:41:51,280 --> 00:41:52,720 INITIATION OR AS A REPLACEMENT 1016 00:41:52,720 --> 00:41:56,160 FOR CONVENTIONAL ART AND IT'S 1017 00:41:56,160 --> 00:41:56,960 THE YOU WILL HAT GOAL IS OF 1018 00:41:56,960 --> 00:41:59,240 ACHIEVING A SUSTAINED ART FREE 1019 00:41:59,240 --> 00:41:59,960 HIV REMISSION. 1020 00:41:59,960 --> 00:42:01,840 THE STUDIES SHOULD BE CARRIED 1021 00:42:01,840 --> 00:42:04,400 OUT IN ANIMAL MODELS. 1022 00:42:04,400 --> 00:42:07,640 CLINICAL TRIALS ARE EXCLUDED BUT 1023 00:42:07,640 --> 00:42:12,240 CELLS OR TISSUE SAMPLES CAN BE 1024 00:42:12,240 --> 00:42:12,560 USED. 1025 00:42:12,560 --> 00:42:14,360 THE MECHANISM IS A GRANT AND THE 1026 00:42:14,360 --> 00:42:19,160 ACTIVITY ROAD IS RO1 AND R21. 1027 00:42:19,160 --> 00:42:21,120 THE BACKGROUND IS THAT CURRENT 1028 00:42:21,120 --> 00:42:22,720 HIV APPROACHES ARE FOCUSED 1029 00:42:22,720 --> 00:42:25,680 ALMOST EXCLUSIVELY ON STRATEGIES 1030 00:42:25,680 --> 00:42:28,960 OF THE COMPLETE ART SUPPRESSION. 1031 00:42:28,960 --> 00:42:30,320 RECENT HITS IN THE STRATEGIST 1032 00:42:30,320 --> 00:42:31,640 HOWEVER THAT MOST OF THE 1033 00:42:31,640 --> 00:42:32,960 RESERVOIR BECOMES STABILIZED AND 1034 00:42:32,960 --> 00:42:35,920 AT THE START OF ART AND ALSO THE 1035 00:42:35,920 --> 00:42:40,160 TIMING OF HIV RESERVOIR IS 1036 00:42:40,160 --> 00:42:41,920 COMPLICATED AND UNDER 1037 00:42:41,920 --> 00:42:42,280 INVESTIGATION. 1038 00:42:42,280 --> 00:42:43,560 ALSO SOME APPROACHES IN THE 1039 00:42:43,560 --> 00:42:45,560 ABSENCE OF ART HAVE RESULTED IN 1040 00:42:45,560 --> 00:42:51,120 SUSTAINEDSUN ROW MISSION AND NH. 1041 00:42:51,120 --> 00:42:52,920 ARE THERE OPPORTUNITIES TO 1042 00:42:52,920 --> 00:42:54,680 INTERVENE BEFORE COMPLETE ART 1043 00:42:54,680 --> 00:43:00,200 SUPPRESSION OR AFTER ANN ANALYTL 1044 00:43:00,200 --> 00:43:02,560 AND IT SIMULATES THE IMMUNE 1045 00:43:02,560 --> 00:43:04,040 RESPONSE TIME PROVE THE OUTCOME 1046 00:43:04,040 --> 00:43:08,320 OF AN HIV CURE. 1047 00:43:08,320 --> 00:43:12,320 THIS SLIDE DID ADAPTED FROM A 1048 00:43:12,320 --> 00:43:14,680 FIGURE AND BOB. 1049 00:43:14,680 --> 00:43:15,760 CURRENT CURE STRATEGIES ARE 1050 00:43:15,760 --> 00:43:20,280 DESIGNED TO INTER VEN DURING 1051 00:43:20,280 --> 00:43:22,240 CHRONIC ART WHEN HIV IS 1052 00:43:22,240 --> 00:43:22,520 SUPPRESSED. 1053 00:43:22,520 --> 00:43:24,280 THE OUTCOMES CAN BE NO EFFECT, 1054 00:43:24,280 --> 00:43:29,160 CONTROL OF REBOUND OR 1055 00:43:29,160 --> 00:43:30,320 ERADICATION. 1056 00:43:30,320 --> 00:43:33,000 THE QUESTION IS WHETHER IT WILL 1057 00:43:33,000 --> 00:43:35,040 MAKE A DIFFERENCE TO INTERVENE 1058 00:43:35,040 --> 00:43:36,680 HERE AROUND THE TIME OF ART 1059 00:43:36,680 --> 00:43:38,080 INITIATION OR IN PLACE OF 1060 00:43:38,080 --> 00:43:39,240 CONVENTIONAL ART. 1061 00:43:39,240 --> 00:43:42,320 NEXT SLIDE, PLEASE. 1062 00:43:42,320 --> 00:43:44,320 THE LONGITUDINAL LEVELS OF 1063 00:43:44,320 --> 00:43:46,160 PLASMA AFTER ART NISHTATION WERE 1064 00:43:46,160 --> 00:43:49,200 PUBLISHED RECENTLY AND THERE'S A 1065 00:43:49,200 --> 00:43:51,120 DECAY WHICH AN AVERAGE HALF LIFE 1066 00:43:51,120 --> 00:43:53,200 OF 1.2 DAYS FOR PHASE 1 AND 30 1067 00:43:53,200 --> 00:43:55,240 DAYS FOR PHASE 2. 1068 00:43:55,240 --> 00:43:57,360 AND IN CONCLUSION, ON GOING 1069 00:43:57,360 --> 00:43:58,480 VIRUS PRODUCTION OCCURS MOSTLY 1070 00:43:58,480 --> 00:44:01,120 IN THE FIRST THREE MONTHS OF THE 1071 00:44:01,120 --> 00:44:01,560 INFECTION. 1072 00:44:01,560 --> 00:44:03,640 BETWEEN THREE AND SIX MONTHS, 1073 00:44:03,640 --> 00:44:05,520 HIV PRODUCTION DECLINES MORE 1074 00:44:05,520 --> 00:44:07,040 SLOWLY AFTER WHICH TIME POINT IT 1075 00:44:07,040 --> 00:44:11,120 BECOMES UNDETECTABLE. 1076 00:44:11,120 --> 00:44:13,520 INTERVENTION TO ART AND PLASMA 1077 00:44:13,520 --> 00:44:14,920 VIRUSES IN STEEP DECLINE MAY 1078 00:44:14,920 --> 00:44:17,320 ACCELERATE THE TIME TO FULL 1079 00:44:17,320 --> 00:44:20,040 SUPPRESSION AND MAY REDUCE THE 1080 00:44:20,040 --> 00:44:23,960 SIZE OF THE LATENT RESERVOIR. 1081 00:44:23,960 --> 00:44:28,080 THIS PAPER FROM ABRAMS FROM THE 1082 00:44:28,080 --> 00:44:30,600 OO2 STUDIES A SMALL COHORT OF 1083 00:44:30,600 --> 00:44:33,320 NINE WOMEN WHOSE HIV SUB TYPES C 1084 00:44:33,320 --> 00:44:35,720 THAT LIVED FOR AN AVERAGE OF 4.5 1085 00:44:35,720 --> 00:44:38,040 YEARS WITHOUT ART. 1086 00:44:38,040 --> 00:44:40,040 IT WAS DEMONSTRATED TO 71% OF 1087 00:44:40,040 --> 00:44:42,160 THE VIRAL RESERVOIR WAS MET TO 1088 00:44:42,160 --> 00:44:45,440 THE YEAR PROCEEDING ART. 1089 00:44:45,440 --> 00:44:47,680 ONLY 4% OF RESERVOIR VIRUS MET 1090 00:44:47,680 --> 00:44:50,800 TO THE FIRST YEAR OF INFECTION. 1091 00:44:50,800 --> 00:44:52,440 THE PAPER CONCLUDED THAT THE 1092 00:44:52,440 --> 00:44:54,360 LATE ANT VIRAL RESERVOIR IS 1093 00:44:54,360 --> 00:44:56,960 ESTABLISHED AT THE TIME OF ART 1094 00:44:56,960 --> 00:44:57,240 INITIATION. 1095 00:44:57,240 --> 00:44:59,080 AND REPRESENTS VIRUSES THAT 1096 00:44:59,080 --> 00:45:01,560 EMERGED IN THE YEAR BEFORE ART 1097 00:45:01,560 --> 00:45:02,320 WAS GIVEN. 1098 00:45:02,320 --> 00:45:04,160 OTHER STUDIES IN DIFFERENT 1099 00:45:04,160 --> 00:45:05,400 COHORTS WITH DIFFERENT HIV 1100 00:45:05,400 --> 00:45:07,520 SUPPOSE TYPES ARE ON GOING. 1101 00:45:07,520 --> 00:45:11,960 NEXT SLIDE, PLEASE. 1102 00:45:11,960 --> 00:45:15,880 THIS PAPER DEMONSTRATES THAT AN 1103 00:45:15,880 --> 00:45:17,640 IMMUNOTHERAPY DURING ACUTE SHIFT 1104 00:45:17,640 --> 00:45:20,120 INFECTION IS LONG-TERM 1105 00:45:20,120 --> 00:45:22,200 SUPPRESSION OF A REEMIA IN THE 1106 00:45:22,200 --> 00:45:25,800 ABSENCE OF ART. 1107 00:45:25,800 --> 00:45:30,800 THE ANTIBODIES 3BNC117 AND 1108 00:45:30,800 --> 00:45:33,960 10-1074 POTENTLY REDUCE VERREMIA 1109 00:45:33,960 --> 00:45:36,040 AND IN ADDITION IMMUNE COMPLEX 1110 00:45:36,040 --> 00:45:39,400 FORMATION MAY INCLUDE A VACCINAL 1111 00:45:39,400 --> 00:45:42,480 EFFECT AND ACTIVE PRODUCTION 1112 00:45:42,480 --> 00:45:43,920 STIMULATES THE IMMUNE RESPONSE 1113 00:45:43,920 --> 00:45:46,040 AND Dr. FAUCI PRESENTED THE 1114 00:45:46,040 --> 00:45:56,600 CLINICAL TRIAL USING THESE -- IF 1115 00:45:59,640 --> 00:46:04,560 IT'S SHOWN IN THIS SLIDE. 1116 00:46:04,560 --> 00:46:09,160 THEY WERE GIVEN SHIFT AAV FOR 36 1117 00:46:09,160 --> 00:46:14,560 WEEKS AND AT ONE TIME SHOT OF 1118 00:46:14,560 --> 00:46:18,280 AAV-ENCODED 3BNC117 AND 10-1074 1119 00:46:18,280 --> 00:46:19,760 WAS DELIVERED. 1120 00:46:19,760 --> 00:46:21,600 THE ANTIBODY WAS ALSO 1121 00:46:21,600 --> 00:46:22,800 ADMINISTERED BUT WAS CLEARED 1122 00:46:22,800 --> 00:46:25,040 FAST AFTER THE DEVELOPMENT OF 1123 00:46:25,040 --> 00:46:27,440 ANTIDRUG ANTIBODIES. 1124 00:46:27,440 --> 00:46:29,760 TWO OUR THE FOUR SHOWED AND THIS 1125 00:46:29,760 --> 00:46:34,440 IS THE FAMOUS MONKEY IN RED 1126 00:46:34,440 --> 00:46:36,520 HAVING UNDETECTABLE VIRAL LOADS. 1127 00:46:36,520 --> 00:46:39,040 NEXT SLIDE, PLEASE. 1128 00:46:39,040 --> 00:46:41,040 ENCOURAGING ALSO THE RESULTS 1129 00:46:41,040 --> 00:46:44,560 FROM THE STUDY PRESENTED AT 1130 00:46:44,560 --> 00:46:45,120 2022. 1131 00:46:45,120 --> 00:46:46,320 VOLUNTEERS WERE EITHER TREATED 1132 00:46:46,320 --> 00:46:52,520 WITH OUT A LOAN, ART PLUS 1133 00:46:52,520 --> 00:46:54,760 3BNC117 OR COMBINATION OF ALL 1134 00:46:54,760 --> 00:46:57,680 THREE AND DURING OUT INITIATION 1135 00:46:57,680 --> 00:47:00,800 INCREASED THE PREPORTION OF P24 1136 00:47:00,800 --> 00:47:02,960 POSITIVE CD4 CELLS WITH LATEN 1137 00:47:02,960 --> 00:47:06,840 SEE REVERSAL. 1138 00:47:06,840 --> 00:47:09,720 3BNC117 LED TO A FASTER SECOND 1139 00:47:09,720 --> 00:47:11,680 PHASE PLASMA DECAY AND 1140 00:47:11,680 --> 00:47:13,600 FACILITATED ELIMINATION OF 1141 00:47:13,600 --> 00:47:14,200 INFECTED CELLS. 1142 00:47:14,200 --> 00:47:18,680 OVER ALL, ONE PERSON FROM THIS 1143 00:47:18,680 --> 00:47:20,360 3BNC117 PLUS RMD GROUP CONTINUES 1144 00:47:20,360 --> 00:47:23,400 TO HAVE UNDETECTABLE VIRAL LOAD 1145 00:47:23,400 --> 00:47:24,480 3.7 YEARS AFTER STOPPING ART 1146 00:47:24,480 --> 00:47:29,760 WHICH IS HIGHLIGHTED IN RED. 1147 00:47:29,760 --> 00:47:33,080 SO, THIS SCOPE OF THIS 1148 00:47:33,080 --> 00:47:35,040 INITIATIVE PROPOSAL IS DIVIDED 1149 00:47:35,040 --> 00:47:37,440 INTO BASIC RESEARCH AND TARGETED 1150 00:47:37,440 --> 00:47:38,200 INTERVENTIONS. 1151 00:47:38,200 --> 00:47:41,560 FOR BASIC RESEARCH, SUPPORTING 1152 00:47:41,560 --> 00:47:46,480 ARE FIRST RESEARCH TO MAP HIV 1153 00:47:46,480 --> 00:47:47,560 RESERVOIR AND DIFFERENT TYPES 1154 00:47:47,560 --> 00:47:50,960 AND TISSUE AT VARIOUS TIME POINT 1155 00:47:50,960 --> 00:47:52,400 NEAR ART INITIATION AND THERE'S 1156 00:47:52,400 --> 00:47:54,480 ADJUSTED TOPICS COULD INCLUDE 1157 00:47:54,480 --> 00:47:55,680 COMPARING DIFFERENT HIV SUPPOSE 1158 00:47:55,680 --> 00:47:57,840 TYPES ACUTE VERSUS CHRONIC 1159 00:47:57,840 --> 00:47:59,640 INFECTION AND HUMAN VERSUS 1160 00:47:59,640 --> 00:48:02,000 ANIMAL MODELS AND DIFFERENT 1161 00:48:02,000 --> 00:48:03,880 POPULATIONS AND SECOND ANALYZING 1162 00:48:03,880 --> 00:48:08,280 HIV RESERVOIR DYNAMICS, DOUGH 1163 00:48:08,280 --> 00:48:08,960 KAY RATES AND CLONE 1164 00:48:08,960 --> 00:48:10,400 PROLIFERATION AND PREPORTION OF 1165 00:48:10,400 --> 00:48:12,720 ENACT VERSUS DEFECTIVE VIRUSES 1166 00:48:12,720 --> 00:48:15,000 AND DISTRIBUTION OF ACTIVE 1167 00:48:15,000 --> 00:48:17,000 VERSUS LATENT RESERVOIRS AND 1168 00:48:17,000 --> 00:48:18,240 REACTIVATION POTENTIAL OF LATE 1169 00:48:18,240 --> 00:48:21,520 ANT VIRUSES AT OR NEAR THE TIME 1170 00:48:21,520 --> 00:48:22,280 OF ART INITIATION. 1171 00:48:22,280 --> 00:48:26,080 AND FINALLY, COMPARING RESERVOIR 1172 00:48:26,080 --> 00:48:30,360 OR IMMUNO LOGIC STRATEGIES 1173 00:48:30,360 --> 00:48:31,400 DELIVERED AT DIFFERENT TIMES 1174 00:48:31,400 --> 00:48:32,840 POINTS WERE IN PLACE OF 1175 00:48:32,840 --> 00:48:35,080 CONVENTIONAL ART INCLUDING 1176 00:48:35,080 --> 00:48:36,920 VISUALIZATION STUDIES AND THE 1177 00:48:36,920 --> 00:48:39,360 APPLICANTS CAN USE EITHER CELLS 1178 00:48:39,360 --> 00:48:43,880 ANIMAL MODELS OR EXISTING EX 1179 00:48:43,880 --> 00:48:47,240 VIVO HUMAN CLINICAL SAMPLES AND 1180 00:48:47,240 --> 00:48:48,640 THE ENCOURAGED TEAM SCIENCE WITH 1181 00:48:48,640 --> 00:48:52,760 GROUPS COLLECTING CLINICAL 1182 00:48:52,760 --> 00:48:54,080 SAMPLES FROM CURE TRIALS. 1183 00:48:54,080 --> 00:48:55,720 NEXT SLIDE, PLEASE. 1184 00:48:55,720 --> 00:48:57,120 FOR TARGETED INTERCEPTIONS, WE 1185 00:48:57,120 --> 00:49:00,000 ARE LOOKING FOR FIRST 1186 00:49:00,000 --> 00:49:01,640 IDENTIFYING EXPERIMENTAL CURE 1187 00:49:01,640 --> 00:49:03,440 APPROACHES AND ANIMAL MODELS 1188 00:49:03,440 --> 00:49:06,600 PRIOR TO THE INITIATION OF ART 1189 00:49:06,600 --> 00:49:07,800 AND THAT CONTRIBUTE TO A 1190 00:49:07,800 --> 00:49:10,920 REDUCTION AND RESERVOIR SIZE AND 1191 00:49:10,920 --> 00:49:11,840 INCREASED DECAY RATE OF THE 1192 00:49:11,840 --> 00:49:12,680 RESERVOIR OR POST TREATMENT 1193 00:49:12,680 --> 00:49:15,760 CONTROL OF VIRAL REBOUND AND 1194 00:49:15,760 --> 00:49:17,520 SECOND, IDENTIFYING SHORT-TERM 1195 00:49:17,520 --> 00:49:19,640 STRATEGY IN PRE-CLINICAL MODELS 1196 00:49:19,640 --> 00:49:21,240 INSTEAD OF OR IN COMBINATION 1197 00:49:21,240 --> 00:49:23,360 WITH ART, THAT COULD DIFFER FROM 1198 00:49:23,360 --> 00:49:24,560 LIFE-LONG ART IN ENABLING 1199 00:49:24,560 --> 00:49:27,040 DURABLE CONTROL OF REBOUND WITH 1200 00:49:27,040 --> 00:49:30,120 ONE-TIME OR INTERMITTENT USE AND 1201 00:49:30,120 --> 00:49:31,960 EXAMPLES ARE INHIBITING LATTEN 1202 00:49:31,960 --> 00:49:33,320 SEE ESTABLISHMENT IN THE ART 1203 00:49:33,320 --> 00:49:35,560 START, PREVENTING CLONE ALEX 1204 00:49:35,560 --> 00:49:38,320 PANS OF RESERVOIR CELLS, 1205 00:49:38,320 --> 00:49:39,800 PREVENTING HIV DISSEMINATION, 1206 00:49:39,800 --> 00:49:42,200 AND LIMITING RESERVOIR SEEDING 1207 00:49:42,200 --> 00:49:47,040 IN SANCTUARY SITES. 1208 00:49:47,040 --> 00:49:48,600 PROGRAMS THAT ARE RELATED ARE 1209 00:49:48,600 --> 00:49:51,560 THE MARTIN DELANIE CO LAB TIRES 1210 00:49:51,560 --> 00:49:54,560 RENEWED AT THE END OF 2021 AND 1211 00:49:54,560 --> 00:49:59,080 THE CONSORTIA FOR INNOVATIVE AID 1212 00:49:59,080 --> 00:50:01,320 RESEARCH IN NON HUMAN PRIMATES 1213 00:50:01,320 --> 00:50:04,880 AND FOR INNOVATIVE HIV VACCINE 1214 00:50:04,880 --> 00:50:06,480 AND CURE RESEARCH AS WELL AS 1215 00:50:06,480 --> 00:50:07,920 UNDERSTANDING HIV REBOUND AND 1216 00:50:07,920 --> 00:50:16,920 HIV RESERVOIR DYNAMICS TO 1217 00:50:16,920 --> 00:50:19,160 ELIMINATION AND FOR WHICH THE 1218 00:50:19,160 --> 00:50:24,400 SUBMISSION AND ENDED. 1219 00:50:24,400 --> 00:50:27,680 THEY AND BY THE TIME OF ART AND 1220 00:50:27,680 --> 00:50:28,360 CONVENTIONAL ART. 1221 00:50:28,360 --> 00:50:31,200 NEXT SLIDE, PLEASE. 1222 00:50:31,200 --> 00:50:33,880 WE WOULD LIKE TO THANK Dr. 1223 00:50:33,880 --> 00:50:36,680 MONICA GANDHI FROM THE 1224 00:50:36,680 --> 00:50:37,800 UNIVERSITY OF CALIFORNIA SAN 1225 00:50:37,800 --> 00:50:42,320 FRANCISCO AND Dr. RICHARD FOR 1226 00:50:42,320 --> 00:50:43,720 THE HELP FOR COMMENTS AND 1227 00:50:43,720 --> 00:50:45,440 SUGGESTIONS IN THE PRE REVIEW OF 1228 00:50:45,440 --> 00:50:49,280 THIS CONCEPT, NEXT SLIDE, 1229 00:50:49,280 --> 00:50:49,680 PLEASE. 1230 00:50:49,680 --> 00:50:52,360 THERE ARE OVER ALL IMPRESSION 1231 00:50:52,360 --> 00:50:54,560 WAS THIS IS AN EXCITING AND 1232 00:50:54,560 --> 00:50:55,480 WONDERFUL INITIATIVE AND 1233 00:50:55,480 --> 00:50:57,280 INTERESTING CONCEPT, HOWEVER, WE 1234 00:50:57,280 --> 00:50:59,200 SHOULD MAKE IT CLEAR THAT THIS 1235 00:50:59,200 --> 00:51:00,600 IS NOT A FLOOR FOR CLINICAL 1236 00:51:00,600 --> 00:51:02,200 TRIALS BUT FOR BASIC SCIENCE 1237 00:51:02,200 --> 00:51:05,280 APPROACHES AND EXPERIMENTAL 1238 00:51:05,280 --> 00:51:07,080 SILENT ANIMAL MODELS AND OUR 1239 00:51:07,080 --> 00:51:08,240 RESPONSE IS WE CHANGE THE 1240 00:51:08,240 --> 00:51:10,600 OBJECTIVE AND REPLACED 1241 00:51:10,600 --> 00:51:12,040 INTERVENTION WITH EXPERIMENTS. 1242 00:51:12,040 --> 00:51:16,160 WE SHOULD ALSO KEEP THE R21 1243 00:51:16,160 --> 00:51:18,680 MECHANISM AND THE FOA AND 1244 00:51:18,680 --> 00:51:19,720 ENCOURAGE EARLY STAGE 1245 00:51:19,720 --> 00:51:20,760 INVESTIGATORS TO APPLY. 1246 00:51:20,760 --> 00:51:22,760 IT WAS ENCOURAGING AND WE WILL 1247 00:51:22,760 --> 00:51:24,440 IMPLEMENT IF THE INITIATIVE IS 1248 00:51:24,440 --> 00:51:25,520 APPROVED. 1249 00:51:25,520 --> 00:51:26,600 NEXT SLIDE, PLEASE. 1250 00:51:26,600 --> 00:51:29,240 THE REVIEWERS COMMENT WAS TO 1251 00:51:29,240 --> 00:51:30,600 ENCOURAGE TEAM SCIENCE AND 1252 00:51:30,600 --> 00:51:31,440 COLLABORATIONS WITH GROUPS 1253 00:51:31,440 --> 00:51:33,920 COLLECTING CLINICAL SAMPLES FROM 1254 00:51:33,920 --> 00:51:35,880 CURE TRIALS AND OUR RESPONSE IS 1255 00:51:35,880 --> 00:51:37,240 THAT WE WILL MAKE IN CLEAR IN 1256 00:51:37,240 --> 00:51:39,480 THE FOA IF THE CONCEPT IS 1257 00:51:39,480 --> 00:51:40,480 APPROVED. 1258 00:51:40,480 --> 00:51:41,920 FINALLY, WE WILL REQUEST TO MAKE 1259 00:51:41,920 --> 00:51:43,880 CHANGES TO THE SCOPE OF 1260 00:51:43,880 --> 00:51:45,880 INITIATIVES ON SLIDES 10 AND 11 1261 00:51:45,880 --> 00:51:49,280 TO PROVIDE CLARITY AND WHICH WE 1262 00:51:49,280 --> 00:51:49,720 IMPLEMENTED. 1263 00:51:49,720 --> 00:51:52,120 NEXT SLIDE, PLEASE. 1264 00:51:52,120 --> 00:51:53,760 THE LAST SLIDE IS A REPEAT OF 1265 00:51:53,760 --> 00:51:55,560 THE FIRST SLIDE. 1266 00:51:55,560 --> 00:51:56,520 SHOWING THE INITIATIVE TITLE, 1267 00:51:56,520 --> 00:52:03,600 THE OBJECTIVE AND THE MECHANISM. 1268 00:52:03,600 --> 00:52:04,800 THANK YOU FOR YOUR ATTENTION AND 1269 00:52:04,800 --> 00:52:09,000 THANK YOU VERY MUCH FOR YOUR 1270 00:52:09,000 --> 00:52:09,200 TIME. 1271 00:52:09,200 --> 00:52:11,600 >> THANK YOU Dr. SANDERS. 1272 00:52:11,600 --> 00:52:13,840 FASCINATING DATA AND PROVOCATIVE 1273 00:52:13,840 --> 00:52:15,800 IDEAS PROPOSED HERE. 1274 00:52:15,800 --> 00:52:18,240 WE DO HAVE TIME FOR A FEW 1275 00:52:18,240 --> 00:52:20,240 QUESTIONS IF PEOPLE HAVE 1276 00:52:20,240 --> 00:52:20,800 QUESTIONS. 1277 00:52:20,800 --> 00:52:22,720 LET ME -- PAM JUST PUT IN THE 1278 00:52:22,720 --> 00:52:24,000 CHAT, LET ME REMIND PEOPLE ON 1279 00:52:24,000 --> 00:52:25,920 THE COMMITTEE TO OPEN THE 1280 00:52:25,920 --> 00:52:31,920 ELECTRONIC COUNCIL BOOKS AND GO 1281 00:52:31,920 --> 00:52:33,520 TO THE DAIDS TAB AND THE SUB 1282 00:52:33,520 --> 00:52:35,400 LINE THERE TO BE ABLE TO VOTE ON 1283 00:52:35,400 --> 00:52:41,680 THIS AND THE OTHER CONCEPTS. 1284 00:52:41,680 --> 00:52:51,920 ANY QUESTIONS? 1285 00:53:05,800 --> 00:53:08,240 >> THANK YOU Dr. SANDERS AND 1286 00:53:08,240 --> 00:53:09,120 IT'S AN EXCITING OPPORTUNITY. 1287 00:53:09,120 --> 00:53:19,600 IF PEOPLE CAN GO AND ARE WE 1288 00:53:28,840 --> 00:53:31,280 AHEAD OF SCHEDULE? 1289 00:53:31,280 --> 00:53:36,680 >> ALL RIGHT. 1290 00:53:36,680 --> 00:53:42,600 WE'LL GIVE PEOPLE A MOMENT. 1291 00:53:42,600 --> 00:53:44,240 >> SO IF SOMEONE IS MONITORING 1292 00:53:44,240 --> 00:53:46,520 THE ECB, CAN YOU LET KEN KNOW 1293 00:53:46,520 --> 00:53:50,200 WHEN THE VOTES ARE ALL IN. 1294 00:53:50,200 --> 00:53:52,440 >> CAN I ASK A SILLY QUESTION, 1295 00:53:52,440 --> 00:53:53,880 THIS IS AUDRY, I'M HAVING A HARD 1296 00:53:53,880 --> 00:53:55,440 TIME FINDING EXACTLY WHERE THE 1297 00:53:55,440 --> 00:53:59,320 VOTING ROSTER IS HERE FOR THESE. 1298 00:53:59,320 --> 00:54:02,080 >> IT'S -- WE ALL HAVE THAT SAME 1299 00:54:02,080 --> 00:54:02,760 HARD TIME. 1300 00:54:02,760 --> 00:54:05,120 IF YOU OPEN THE ECB THERE'S A 1301 00:54:05,120 --> 00:54:06,400 TEAM ON THE TOP AND YOU NEED 1302 00:54:06,400 --> 00:54:08,280 THREE E-MAILS, THE ORIGINAL AND 1303 00:54:08,280 --> 00:54:11,240 THERE'S TWO E-MAILS WITH IT WITH 1304 00:54:11,240 --> 00:54:14,480 THE PASSWORDS AND THERE'S THE 1305 00:54:14,480 --> 00:54:19,040 DAIDS TAB ON TOP AND GO DOWN TO 1306 00:54:19,040 --> 00:54:20,240 OPEN SESSION. 1307 00:54:20,240 --> 00:54:21,640 THE THIRD HEADER AND THEN THE 1308 00:54:21,640 --> 00:54:27,920 RIGHT OF THAT VO ON DOCUMENT AND 1309 00:54:27,920 --> 00:54:35,640 THAT GETS YOU TO THE VOTES. 1310 00:54:35,640 --> 00:54:38,600 IT USUALLY TAKES ME SEVERAL 1311 00:54:38,600 --> 00:54:39,840 EFFORTS EVERY MEETING. 1312 00:54:39,840 --> 00:54:40,760 >> THANK YOU. 1313 00:54:40,760 --> 00:54:44,840 I WAS TOO FAR DOWN. 1314 00:54:44,840 --> 00:54:47,160 WHEN YOU RETIRE HE HAVE A JOB 1315 00:54:47,160 --> 00:54:48,800 FOR YOU IN I.T. HERE. 1316 00:54:48,800 --> 00:54:52,000 >> OH, YES. 1317 00:54:52,000 --> 00:54:52,400 [LAUGHTER] 1318 00:54:52,400 --> 00:54:52,840 >> THANK YOU. 1319 00:54:52,840 --> 00:54:56,720 >> THANK YOU. 1320 00:54:56,720 --> 00:54:57,080 >> OK. 1321 00:54:57,080 --> 00:55:00,840 SHALL WE BRING UP THE SECOND 1322 00:55:00,840 --> 00:55:01,600 BASIC SCIENCE. 1323 00:55:01,600 --> 00:55:08,320 >> THERE'S ANOTHER TECHNICAL 1324 00:55:08,320 --> 00:55:09,640 QUESTION. 1325 00:55:09,640 --> 00:55:12,080 >> IT WAS A REQUEST BECAUSE YOU 1326 00:55:12,080 --> 00:55:16,440 GET LOGGED ON AND HAVE TO LOG 1327 00:55:16,440 --> 00:55:19,680 BACK IN. 1328 00:55:19,680 --> 00:55:24,120 >> WHERE DO YOU VOTE ON THE RED 1329 00:55:24,120 --> 00:55:26,840 ONES? 1330 00:55:26,840 --> 00:55:30,360 >> THERE'S A VOTE ON DOCUMENTS. 1331 00:55:30,360 --> 00:55:33,280 THIS IS MEANT TO BE A TRICK AND 1332 00:55:33,280 --> 00:55:37,280 IT WORKS WELL. 1333 00:55:37,280 --> 00:55:38,960 IF YOU JUST OPEN AND CLOSE IT 1334 00:55:38,960 --> 00:55:40,840 EVERY COUPLE OF MINUTES, DURING 1335 00:55:40,840 --> 00:55:42,840 THE PRESENTATIONS IT STAYS OPEN. 1336 00:55:42,840 --> 00:55:44,960 >> THAT'S WHAT I WAS DOING. 1337 00:55:44,960 --> 00:55:48,320 >> YES. 1338 00:55:48,320 --> 00:55:51,240 >> EVERYBODY HAS VOTED SO THANK 1339 00:55:51,240 --> 00:55:52,560 YOU FOR TAKING CARE OF THAT. 1340 00:55:52,560 --> 00:55:53,920 >> WE'RE A SMART CREW HERE. 1341 00:55:53,920 --> 00:55:57,760 YOU ALL UNDERESTIMATE US. 1342 00:55:57,760 --> 00:55:57,920 OK. 1343 00:55:57,920 --> 00:55:58,600 THANK YOU. 1344 00:55:58,600 --> 00:56:02,640 SO, OUR NEXT CONCEPT IS ALSO 1345 00:56:02,640 --> 00:56:03,440 VERY INTERESTING. 1346 00:56:03,440 --> 00:56:05,680 THIS IS ENTITLED PRELIMINARY 1347 00:56:05,680 --> 00:56:08,880 OUTCOMES AND SEE QUELL EYE AFTER 1348 00:56:08,880 --> 00:56:11,680 TREATMENT OF TB OR POST TB IT 1349 00:56:11,680 --> 00:56:14,720 WILL BE PRESENT BID Dr. ROBIN 1350 00:56:14,720 --> 00:56:16,720 HUBNER OF THE EPIDEMIOLOGY 1351 00:56:16,720 --> 00:56:18,240 BRANCH IN THE BASIC SCIENCES 1352 00:56:18,240 --> 00:56:20,000 PROGRAM SOMEONE I HAVE WORKED 1353 00:56:20,000 --> 00:56:24,880 WITH FOR 15 PLUS YEARS AND THANK 1354 00:56:24,880 --> 00:56:25,960 YOU, ROBIN. 1355 00:56:25,960 --> 00:56:27,840 >> I JUST COMMENT IS THERE MUST 1356 00:56:27,840 --> 00:56:30,080 BE A JOKE IN THERE ABOUT HOW 1357 00:56:30,080 --> 00:56:33,200 MANY MDs AND PH.DES IT TAKES 1358 00:56:33,200 --> 00:56:38,000 TO VOTE TODAY, RIGHT. 1359 00:56:38,000 --> 00:56:42,080 ANYWAY, THE NEXT SLIDE PLEASE. 1360 00:56:42,080 --> 00:56:46,360 THIS IS PULMONARY OUTCOMES AND 1361 00:56:46,360 --> 00:56:48,160 SEQUELAE AFTER TREATMENT OF TB 1362 00:56:48,160 --> 00:56:54,360 AND OBSERVATIONAL RESEARCH AND 1363 00:56:54,360 --> 00:56:59,280 MORBIDITY IN TB DISEASE AND HIV 1364 00:56:59,280 --> 00:57:01,040 INFECTED INDIVIDUALS AND THIS IS 1365 00:57:01,040 --> 00:57:09,080 A NEW FOA FIVE-YEARS AND OUR 1366 00:57:09,080 --> 00:57:11,200 PARTNERS ARE NIAID AND NIEHS 1367 00:57:11,200 --> 00:57:16,440 WHICH IS ENVIRONMENTAL HEALTH 1368 00:57:16,440 --> 00:57:18,200 AND CHILDREN TO FOSSIL FUEL AND 1369 00:57:18,200 --> 00:57:23,640 OUTDOOR COOKING, ET CETERA. 1370 00:57:23,640 --> 00:57:26,240 FOR THOSE THAT DON'T KNOW ALL 1371 00:57:26,240 --> 00:57:28,160 I'M SURE MOST YOU DO, 23% OF THE 1372 00:57:28,160 --> 00:57:29,640 WORLD'S POPULATION IS EFFECTED 1373 00:57:29,640 --> 00:57:30,760 BY TUBERCULOSIS AND THERE ARE 1374 00:57:30,760 --> 00:57:33,280 MORE THAN 9 MILLION NEW CASES 1375 00:57:33,280 --> 00:57:35,800 ANNUALLY OF WHICH 1.1 MILLION 1376 00:57:35,800 --> 00:57:38,800 ARE UNDER THE AGE OF 15. 1377 00:57:38,800 --> 00:57:42,040 CURE IS A DISAPPEARANCE OF MTB 1378 00:57:42,040 --> 00:57:44,800 AND THE RESOLUTION OF CLINICAL 1379 00:57:44,800 --> 00:57:47,440 SYMPTOMS AND RESOLVED EXIST 1380 00:57:47,440 --> 00:57:48,960 X-RAY AFTER SIX TO NINE MONTHS 1381 00:57:48,960 --> 00:57:50,120 OF TREATMENT ALTHOUGH TREATMENTS 1382 00:57:50,120 --> 00:57:52,120 ARE SHOTTENNING. 1383 00:57:52,120 --> 00:57:53,800 DESPITE CURE, UP TO 50% OF 1384 00:57:53,800 --> 00:57:55,600 PATIENTS HAVE PERSISTENT 1385 00:57:55,600 --> 00:57:56,680 PULMONARY DYSFUNCTION AT THE 1386 00:57:56,680 --> 00:57:59,040 TIME OF TREATMENT COMPLETION. 1387 00:57:59,040 --> 00:58:00,440 WHAT WE'RE TALKING ABOUT IS THAT 1388 00:58:00,440 --> 00:58:01,960 AS THE PERSON IS LEAVING THE 1389 00:58:01,960 --> 00:58:04,080 CLINIC AND YOU ARE 1390 00:58:04,080 --> 00:58:05,840 CONGRATULATING THEM ON FINISHING 1391 00:58:05,840 --> 00:58:08,000 THEIR SIX TO NINE MONTHS OF 1392 00:58:08,000 --> 00:58:09,880 TREATMENT, THEY'RE WORKING OUT 1393 00:58:09,880 --> 00:58:11,640 THE DOOR WITH LUNGS THAT MAY NOT 1394 00:58:11,640 --> 00:58:12,840 BE FUNCTIONING PROPERLY. 1395 00:58:12,840 --> 00:58:16,440 AND THIS MAY BE PERMANENT 1396 00:58:16,440 --> 00:58:17,240 PULMONARY DAMAGE. 1397 00:58:17,240 --> 00:58:21,880 FOR ADULTS, IT INVOLVES 1398 00:58:21,880 --> 00:58:28,120 INFLAMMATION, EXCESSIVE BRON 1399 00:58:28,120 --> 00:58:28,960 MUCHIECTASIS AND THERE'S ADULT 1400 00:58:28,960 --> 00:58:35,520 WHO'S HAVE HAD TB OF PULMONARY 1401 00:58:35,520 --> 00:58:37,360 ASPERGILLOCIS AND MAY CONTRIBUTE 1402 00:58:37,360 --> 00:58:39,280 SUBSTANTIALLY TO THE COPD BURDEN 1403 00:58:39,280 --> 00:58:41,160 AND PEOPLE WITH T.B. ARE LIKELY 1404 00:58:41,160 --> 00:58:42,600 TO DIE WITHIN THE FIRST FIVE 1405 00:58:42,600 --> 00:58:43,800 YEARS THAN THE GENERAL 1406 00:58:43,800 --> 00:58:44,600 POPULATION AND THEY DIE OF 1407 00:58:44,600 --> 00:58:48,080 THINGS THAT ARE NOT RELATED TO 1408 00:58:48,080 --> 00:58:50,320 TUBERCULOSIS. 1409 00:58:50,320 --> 00:58:51,640 FOR CHILDREN, MUCH OF THE 1410 00:58:51,640 --> 00:58:54,080 DISEASE IS SUBCLINICAL THROUGH 1411 00:58:54,080 --> 00:58:56,360 CHILDHOOD OR THE DAMAGE AND THEY 1412 00:58:56,360 --> 00:58:58,040 CAN DEVELOP SYMPTOMS AND 1413 00:58:58,040 --> 00:58:59,320 RESPIRATORY MORBIDITY AS THEY 1414 00:58:59,320 --> 00:59:02,800 ENTER ADULTHOOD. 1415 00:59:02,800 --> 00:59:04,320 ONE PEDIATRICIAN TOLD ME THE 1416 00:59:04,320 --> 00:59:05,600 KIDS CAN LOOK FINE AND YOU 1417 00:59:05,600 --> 00:59:07,200 STRESS THEM AND YOU REALIZE 1418 00:59:07,200 --> 00:59:09,200 THEIR LUNGS AREN'T FUNCTIONING. 1419 00:59:09,200 --> 00:59:11,600 THE BOTTOM SLIDE THAT'S IN RED 1420 00:59:11,600 --> 00:59:15,480 SAYS POTENTIALLY 1.75 MILLION 1421 00:59:15,480 --> 00:59:17,280 PERSONS WITH HIV MAY HAVE 1422 00:59:17,280 --> 00:59:19,800 PERSISTENT LUNG DAMAGE FROM T.B. 1423 00:59:19,800 --> 00:59:25,640 SO THIS IS NOT A MINOR PROBLEM. 1424 00:59:25,640 --> 00:59:27,880 SO THE SCIENTIFIC QUESTIONS THAT 1425 00:59:27,880 --> 00:59:30,920 WE'RE INTERESTED IN TB DISEASE 1426 00:59:30,920 --> 00:59:32,320 AND THE AFTERMATH ARE THE 1427 00:59:32,320 --> 00:59:34,120 LEADING CAUSE OF DEATH PEOPLE 1428 00:59:34,120 --> 00:59:38,320 LIVING WITH HIV AND AS I SAID, 1429 00:59:38,320 --> 00:59:47,560 IF YOU'VE HAD EVEN IF ARE 1430 00:59:47,560 --> 00:59:47,960 CONSIDERED CURED. 1431 00:59:47,960 --> 00:59:49,320 LUNG FUNCTION IN ADULT AND 1432 00:59:49,320 --> 00:59:53,840 CHILDREN WITH HIV AND WE DON'T 1433 00:59:53,840 --> 00:59:54,600 KNOW MUCH. 1434 00:59:54,600 --> 00:59:57,080 WE DON'T KNOW THE PREVALENCE AND 1435 00:59:57,080 --> 00:59:58,040 CLINICAL FAN FESSTATION OR 1436 00:59:58,040 --> 01:00:00,720 DIFFERENCES BY HIV STATUS IN 1437 01:00:00,720 --> 01:00:01,000 TREATMENT. 1438 01:00:01,000 --> 01:00:03,840 A LOT OF THE DAMAGE THAT'S DONE 1439 01:00:03,840 --> 01:00:05,240 IS DUE TO THE INDIVIDUAL IMMUNE 1440 01:00:05,240 --> 01:00:06,560 RESPONSE SO IF YOU ARE HIV 1441 01:00:06,560 --> 01:00:08,320 EFFECTED AND YOU DON'T HAVE A 1442 01:00:08,320 --> 01:00:09,920 ROBUST IMMUNE RESPONSE, ARE YOU 1443 01:00:09,920 --> 01:00:10,400 BETTER OFF? 1444 01:00:10,400 --> 01:00:11,720 DO YOU END UP WITH LESS DAMAGE 1445 01:00:11,720 --> 01:00:13,240 AT THE END OF TREATMENT THAN 1446 01:00:13,240 --> 01:00:17,360 SOMEONE WHO ISN'T HIV INFECTED. 1447 01:00:17,360 --> 01:00:21,520 WE DON'T KNOW THOSE ANSWERS ARE 1448 01:00:21,520 --> 01:00:23,240 THERE BIOMARKERS, ARE THERE WAYS 1449 01:00:23,240 --> 01:00:28,120 THAT WE CAN POTENTIALLY IDENTIFY 1450 01:00:28,120 --> 01:00:30,240 INDIVIDUALS THAT GET DAMAGE BY 1451 01:00:30,240 --> 01:00:32,120 BIOMARKERS AND THEN PERHAPS 1452 01:00:32,120 --> 01:00:33,320 AMELIORATE THAT DAMAGE DURING 1453 01:00:33,320 --> 01:00:34,080 THIS TREATMENT. 1454 01:00:34,080 --> 01:00:35,800 ARE THERE RISK FACTORS FOR LUNG 1455 01:00:35,800 --> 01:00:38,080 DYSFUNCTION AND SEVERITY OF 1456 01:00:38,080 --> 01:00:39,120 DAMAGE? 1457 01:00:39,120 --> 01:00:41,120 THESE ARE NUTRITIONAL STATUS, 1458 01:00:41,120 --> 01:00:42,200 BEHAVIORAL FACTORS SUCH AS 1459 01:00:42,200 --> 01:00:44,160 ALCOHOL, TOBACCO USE, AND 1460 01:00:44,160 --> 01:00:45,840 ENVIRONMENT ALEX POSE YOU'RES 1461 01:00:45,840 --> 01:00:48,120 AND ARE THERE IMMUNE FACTORS OR 1462 01:00:48,120 --> 01:00:49,960 MECHANISMS WHICH COULD ENHANCE 1463 01:00:49,960 --> 01:00:51,640 PATHOGENESIS AND POTENTIALLY BE 1464 01:00:51,640 --> 01:00:54,480 TARGETS FOR INTERVENTION AND IN 1465 01:00:54,480 --> 01:00:55,360 ADDITION, WE'RE INTERESTED IN 1466 01:00:55,360 --> 01:00:57,200 THE RISK OF RECURRENT TB AND 1467 01:00:57,200 --> 01:01:00,000 OTHER LUNG INFECTIONS, 1468 01:01:00,000 --> 01:01:01,800 CARDIOVASCULAR DISEASE OR COPD. 1469 01:01:01,800 --> 01:01:06,240 I THINK THERE'S A GROWING BELIEF 1470 01:01:06,240 --> 01:01:07,680 THAT PRIOR TB MAY CONTRIBUTE TO 1471 01:01:07,680 --> 01:01:11,800 THE GLOBAL COPD BURDEN AND AS 1472 01:01:11,800 --> 01:01:14,440 ONE PULL MINUTOLOGIST SAID, THEY 1473 01:01:14,440 --> 01:01:17,280 RECEIVE COPD IN THEIR 40s NOT 1474 01:01:17,280 --> 01:01:21,680 LATER IN PEOPLE WHO WERE NOT TB 1475 01:01:21,680 --> 01:01:22,240 PATIENTS. 1476 01:01:22,240 --> 01:01:26,440 AND ARE THERE STRUCTURAL 1477 01:01:26,440 --> 01:01:27,400 BARRIERS, YOU KNOW, THERE'S 1478 01:01:27,400 --> 01:01:29,680 ECONOMIC IMPACTS OF TB TREATMENT 1479 01:01:29,680 --> 01:01:39,640 AND LONG-TERM MORBIDITY AND MANY 1480 01:01:39,640 --> 01:01:40,360 NEXT SLIDE. 1481 01:01:40,360 --> 01:01:42,000 THE BOTTOM LINE, LITTLE IS KNOWN 1482 01:01:42,000 --> 01:01:47,160 ABOUT THE LONG-TERM SEQUAELE OF 1483 01:01:47,160 --> 01:01:48,720 TB MOST TREATMENT AND LESS ABOUT 1484 01:01:48,720 --> 01:01:50,800 HOW HIV IMPACTS HA AND WE'RE 1485 01:01:50,800 --> 01:01:54,720 INTERESTED IN HIV AND HIV 1486 01:01:54,720 --> 01:02:02,000 TREATMENT BIOMARKERS AND ALSO 1487 01:02:02,000 --> 01:02:03,440 THIS IS AIMED AT BETTER 1488 01:02:03,440 --> 01:02:05,320 UNDERSTANDING THE IMPACT OF HIV 1489 01:02:05,320 --> 01:02:07,440 ARC AND IMMUNE RESPONSE AND 1490 01:02:07,440 --> 01:02:09,320 STRATEGIES TO REDUCE THE BURDEN 1491 01:02:09,320 --> 01:02:12,200 OF LONG-TERM SEE QUELLY 1492 01:02:12,200 --> 01:02:17,080 FOLLOWING THE TREATMENT OF TB. 1493 01:02:17,080 --> 01:02:19,040 SO, RESPONSIVE APPLICATIONS WILL 1494 01:02:19,040 --> 01:02:20,200 ENROLL PARTICIPANTS. 1495 01:02:20,200 --> 01:02:23,040 WE ARE NOT INTERESTED IN 1496 01:02:23,040 --> 01:02:25,760 ENROLLING DINOVO CO HEARTS AND 1497 01:02:25,760 --> 01:02:27,320 FOLLOWING THEM FOR 20 YEARS. 1498 01:02:27,320 --> 01:02:31,360 WE KNOW THAT EXISTING COHORTS 1499 01:02:31,360 --> 01:02:34,400 ARE GROUPS OF TB PATIENTS AND 1500 01:02:34,400 --> 01:02:37,600 SUCH AS AN IDEA IN TB REPORTS 1501 01:02:37,600 --> 01:02:39,600 THE CFARCE COMPLETED CLINICAL 1502 01:02:39,600 --> 01:02:42,440 TRIALS IN THE ACTG AND 1503 01:02:42,440 --> 01:02:43,840 PUBLIC-HEALTH DEPARTMENTS SO WE 1504 01:02:43,840 --> 01:02:46,840 WOULD LIKE TO ENROLL THOSE 1505 01:02:46,840 --> 01:02:51,000 PARTICIPANTS AND THEN ADD ON 1506 01:02:51,000 --> 01:02:51,960 ADDITIONAL EVALUATIONS DURING 1507 01:02:51,960 --> 01:02:55,240 THE TREATMENTS AND AT TREATMENT 1508 01:02:55,240 --> 01:02:55,480 END. 1509 01:02:55,480 --> 01:02:56,880 MANY TB PATIENTS AROUND THE 1510 01:02:56,880 --> 01:03:00,680 WORLD NEVER HAVE A PULMONARY 1511 01:03:00,680 --> 01:03:03,720 FUNCTION TEST DONE SO WE'RE 1512 01:03:03,720 --> 01:03:05,520 TALKING ABOUT ADDING THOSE TESTS 1513 01:03:05,520 --> 01:03:07,280 AND EVALUATIONS TO PEOPLE BEING 1514 01:03:07,280 --> 01:03:09,400 TREATED AS PART OF ANOTHER STUDY 1515 01:03:09,400 --> 01:03:10,800 OR A PUBLIC-HEALTH DEPARTMENT OR 1516 01:03:10,800 --> 01:03:12,600 HAVE BEEN TREATED BECAUSE THEY 1517 01:03:12,600 --> 01:03:16,120 WERE PART OF A CLINICAL TRIAL. 1518 01:03:16,120 --> 01:03:18,160 WE ARE NOT INTERESTED IN 1519 01:03:18,160 --> 01:03:21,280 EVALUATING INDIVIDUAL TB DRUGS 1520 01:03:21,280 --> 01:03:22,360 OR DRUG REGISTER MINUTES AND 1521 01:03:22,360 --> 01:03:29,320 WE'RE NOT INTERESTED IN MDR AND 1522 01:03:29,320 --> 01:03:30,040 ONLY XDIP PATIENTS WE KNOW THEIR 1523 01:03:30,040 --> 01:03:31,560 TREATMENT IS MORE COMPLEX AND 1524 01:03:31,560 --> 01:03:34,280 MUCH LONGER AND WILL HAVE MORE 1525 01:03:34,280 --> 01:03:34,640 DAMAGE. 1526 01:03:34,640 --> 01:03:36,840 WHILE WE DON'T MIND A FEW DRUG 1527 01:03:36,840 --> 01:03:38,360 RESISTANT CASES, WE'RE NOT 1528 01:03:38,360 --> 01:03:42,040 LOOKING FOR ENTIRE COHORTS OF 1529 01:03:42,040 --> 01:03:45,600 MDR AND XDR. 1530 01:03:45,600 --> 01:03:49,720 I THINK WE WOULD LIKE TO THANK 1531 01:03:49,720 --> 01:03:53,200 Dr. GUPTA AND Dr. ABRAMS. 1532 01:03:53,200 --> 01:03:54,560 WE WERE INCORPORATED THEIR 1533 01:03:54,560 --> 01:03:56,800 COMMENTS INTO WHAT I JUST 1534 01:03:56,800 --> 01:03:57,200 PRESENTED. 1535 01:03:57,200 --> 01:03:59,560 THEY FELT THAT IT WAS A VERY 1536 01:03:59,560 --> 01:04:00,920 IMPORTANT INITIATIVE. 1537 01:04:00,920 --> 01:04:02,360 THEY WANTED US TO BE MORE 1538 01:04:02,360 --> 01:04:03,600 FLEXIBLE IN OUR INTERPRETATION 1539 01:04:03,600 --> 01:04:06,920 OF COHORTS SO WE HAVE INCLUDED 1540 01:04:06,920 --> 01:04:09,640 INDIVIDUALS WHO HAVE COMPLETED 1541 01:04:09,640 --> 01:04:12,240 ACTG OR IMPACT CLINICAL TRIALS 1542 01:04:12,240 --> 01:04:14,400 AND WHO FOLLOW-UP COULD BE 1543 01:04:14,400 --> 01:04:15,800 EXTENDED TO LOOK AT 1544 01:04:15,800 --> 01:04:18,720 POST-TREATMENT PATHOLOGY AND 1545 01:04:18,720 --> 01:04:20,920 ALSO, WHOSE ALREADY HAVE 1546 01:04:20,920 --> 01:04:22,640 SELECTED BIOSPECIMENS THAT COULD 1547 01:04:22,640 --> 01:04:24,840 BE EXAMINED FOR BIOMARKERS. 1548 01:04:24,840 --> 01:04:26,640 AND WE'RE INCLUDING EXAMINATION 1549 01:04:26,640 --> 01:04:30,160 OF RISK FACTORS AND WE'RE ALLOW 1550 01:04:30,160 --> 01:04:31,920 FOR PROSPECTIVE ENROLLMENT TO 1551 01:04:31,920 --> 01:04:34,080 INCREASE THE STATISTICAL POWER 1552 01:04:34,080 --> 01:04:36,200 BUT WE'RE HOPING THAT WE DO NOT 1553 01:04:36,200 --> 01:04:38,120 HAVE TO ENROLL PATIENTS 1554 01:04:38,120 --> 01:04:40,600 COMPLETE, YOU KNOW, START FROM 1555 01:04:40,600 --> 01:04:42,400 SCRATCH AND THAT WE COULD ALLOW 1556 01:04:42,400 --> 01:04:44,280 PERSPECTIVE ENROLLMENT TO 1557 01:04:44,280 --> 01:04:47,720 INCREASE POWER FOR CERTAIN 1558 01:04:47,720 --> 01:04:48,200 SCIENTIFIC QUESTIONS. 1559 01:04:48,200 --> 01:04:57,800 I THINK THAT'S THE END. 1560 01:04:57,800 --> 01:05:00,520 WE THANK THE REVIEWERS FOR THEIR 1561 01:05:00,520 --> 01:05:01,000 COMMENTS. 1562 01:05:01,000 --> 01:05:02,200 I FELT LIKE I WAS PREACHING TO 1563 01:05:02,200 --> 01:05:02,800 THE CHOIR. 1564 01:05:02,800 --> 01:05:03,880 I WAS TALKING TO THEM. 1565 01:05:03,880 --> 01:05:07,760 >> THANK YOU, Dr. HUBNER. 1566 01:05:07,760 --> 01:05:15,240 WE HAVE A FEW MOMENTS FOR 1567 01:05:15,240 --> 01:05:25,400 QUESTIONS. 1568 01:05:26,280 --> 01:05:30,440 I GUESS NO ONE HAS QUESTIONS. 1569 01:05:30,440 --> 01:05:39,480 >> I HAVE ONE QUESTION. 1570 01:05:39,480 --> 01:05:39,720 ROBIN. 1571 01:05:39,720 --> 01:05:41,320 FIRST OF ALL, YOU ALREADY HEARD 1572 01:05:41,320 --> 01:05:44,720 MY ENTHUSIASM AND IT'S SUCH AN 1573 01:05:44,720 --> 01:05:46,360 IMPORTANT TOPIC AND HOPEFULLY WE 1574 01:05:46,360 --> 01:05:47,600 WILL GET A LOT MORE NEW IN 1575 01:05:47,600 --> 01:05:47,800 SIGHT. 1576 01:05:47,800 --> 01:05:49,760 DO YOU HAVE ANY SENSE OF HOW 1577 01:05:49,760 --> 01:05:52,760 MUCH OF THIS WILL BE -- IS THE 1578 01:05:52,760 --> 01:05:56,320 PEDIATRIC COMPONENT DEPENDENT ON 1579 01:05:56,320 --> 01:05:58,200 GETTING NICHD FUNDING IN 1580 01:05:58,200 --> 01:05:59,320 PARTNERSHIP OR DO YOU THINK -- 1581 01:05:59,320 --> 01:06:01,040 >> I DON'T BELIEVE SO 1582 01:06:01,040 --> 01:06:02,840 NECESSARILY. 1583 01:06:02,840 --> 01:06:04,320 BECAUSE WE DO -- I HAVE BEEN 1584 01:06:04,320 --> 01:06:08,560 WORKING ON THIS WITH OUR OWN 1585 01:06:08,560 --> 01:06:09,200 PEDIATRIC GROUP. 1586 01:06:09,200 --> 01:06:09,480 >> GREAT. 1587 01:06:09,480 --> 01:06:10,680 >> THEY'RE VERY INTERESTED AS 1588 01:06:10,680 --> 01:06:13,840 WELL AS WITH THE TB TEAM. 1589 01:06:13,840 --> 01:06:15,520 SO, I DON'T THINK THAT -- I 1590 01:06:15,520 --> 01:06:17,880 THINK IF WE GET A GOOD PEDIATRIC 1591 01:06:17,880 --> 01:06:19,400 APPLICATION IN IT WOULDN'T 1592 01:06:19,400 --> 01:06:22,680 NECESSARILY RELY ON NICHD IF IT 1593 01:06:22,680 --> 01:06:29,720 WAS VERY HIV FOCUSED. 1594 01:06:29,720 --> 01:06:31,000 >> GREAT, THANK YOU. 1595 01:06:31,000 --> 01:06:32,880 LET ME REMIND EVERYONE ON THE 1596 01:06:32,880 --> 01:06:37,880 COMMITTEE TO OPEN YOUR ECB 1597 01:06:37,880 --> 01:06:39,080 FOLDERS AND VOTE. 1598 01:06:39,080 --> 01:06:44,120 AND OR REOPEN THEM IF THEY'RE 1599 01:06:44,120 --> 01:06:44,360 CLOSED. 1600 01:06:44,360 --> 01:06:46,120 SO PEOPLE CAN DO THAT AND IT 1601 01:06:46,120 --> 01:06:51,600 WOULD BE GREAT. 1602 01:06:51,600 --> 01:06:53,960 AND ONCE WE ARE SET WITH THAT, 1603 01:06:53,960 --> 01:06:57,520 WE HAVE 10 MINUTES TO TAKE A 1604 01:06:57,520 --> 01:06:58,000 BREAK. 1605 01:06:58,000 --> 01:06:59,640 SO, MAYBE YOU CAN LET ME KNOW 1606 01:06:59,640 --> 01:07:05,000 WHEN THE VOTING IS COMPLETE, 1607 01:07:05,000 --> 01:07:08,400 THAT WOULD BE GREAT. 1608 01:07:08,400 --> 01:07:09,840 ALL THE THE VOTES ARE IN. 1609 01:07:09,840 --> 01:07:11,120 >> SUPER. 1610 01:07:11,120 --> 01:07:11,440 THANK YOU. 1611 01:07:11,440 --> 01:07:15,360 >> OK, LET'S TAKE A 10-MINUTE 1612 01:07:15,360 --> 01:07:18,640 BREAK SO I GUESS UNTIL 2:17. 1613 01:07:18,640 --> 01:07:19,680 THANK YOU EVERYONE, WE'LL BEING 1614 01:07:19,680 --> 01:07:38,160 BACK SHORTLY. 1615 01:07:38,160 --> 01:07:39,960 >>IF YOU CAN REOPEN YOUR 1616 01:07:39,960 --> 01:07:42,080 ELECTRONIC COUNCIL BOOKS OR OPEN 1617 01:07:42,080 --> 01:07:46,560 IF THEY'RE STILL OPEN. 1618 01:07:46,560 --> 01:07:51,640 WE CAN BRING UP THE NEXT 1619 01:07:51,640 --> 01:07:54,880 PRESENTATION. 1620 01:07:54,880 --> 01:07:55,280 GREAT. 1621 01:07:55,280 --> 01:07:59,240 SO THIS IS FROM THE VACCINE 1622 01:07:59,240 --> 01:08:00,880 RESEARCH PROGRAM AND LET ME SHUT 1623 01:08:00,880 --> 01:08:02,040 THAT OFF. 1624 01:08:02,040 --> 01:08:08,920 ENTITLED SIN THEY H SNAP H AND M 1625 01:08:08,920 --> 01:08:12,440 LENTED BY ANGELA MALASPINA. 1626 01:08:12,440 --> 01:08:13,240 >> GOOD MORNING. 1627 01:08:13,240 --> 01:08:15,200 GOOD AFTERNOON, EVERYBODY. 1628 01:08:15,200 --> 01:08:22,120 I THINK I GOT STAY WITH MY TIME 1629 01:08:22,120 --> 01:08:22,600 METHOD. 1630 01:08:22,600 --> 01:08:24,200 FROM THE PROGRAM AND WE PRESENT 1631 01:08:24,200 --> 01:08:30,960 IN A NEW CONCEPT SIN NET SNAP-H 1632 01:08:30,960 --> 01:08:32,640 WITH THE THERAPEUTIC RESEARCH 1633 01:08:32,640 --> 01:08:36,440 PROGRAM IN THE BASIC SCIENCES 1634 01:08:36,440 --> 01:08:38,240 PROGRAM WHICH STEPHEN SMILEY AND 1635 01:08:38,240 --> 01:08:40,200 BRIGITTE SANDERS AND OTHERS. 1636 01:08:40,200 --> 01:08:43,200 SO THE OBJECTIVE OF THIS CONCEPT 1637 01:08:43,200 --> 01:08:46,520 IS ADVANCE NUCLEIC PLATFORM FOR 1638 01:08:46,520 --> 01:08:48,320 THE RAPID DEVELOPMENT AND 1639 01:08:48,320 --> 01:08:52,040 TESTING OF PRO FOE LAUGH TICK 1640 01:08:52,040 --> 01:08:56,360 AND VACCINES AND THE ANTIBODIES 1641 01:08:56,360 --> 01:08:58,680 AND ANTIBODIES PREVENTION AND 1642 01:08:58,680 --> 01:09:00,600 TREATMENT AND CURE SO THE 1643 01:09:00,600 --> 01:09:03,800 ADVANTAGES OF THE PLATFORM IS 1644 01:09:03,800 --> 01:09:06,120 FOR EXAMPLE, IN TERMS OF SPEED 1645 01:09:06,120 --> 01:09:07,200 OF MANUFACTURE AND TESTING AND 1646 01:09:07,200 --> 01:09:10,240 SO THE GOAL OF THIS CONCEPT IS 1647 01:09:10,240 --> 01:09:11,560 THE EXPERIENCES AND LESSON 1648 01:09:11,560 --> 01:09:14,800 LEARNED FROM THIS TECHNOLOGY AND 1649 01:09:14,800 --> 01:09:19,960 THEM INTO NIH FOR WE CHOSE THE 1650 01:09:19,960 --> 01:09:21,640 R61/R33 BUY FACE IKA WARD OF 1651 01:09:21,640 --> 01:09:23,520 FIVE YEARS AND THE APPLICANTS 1652 01:09:23,520 --> 01:09:25,360 MAY REQUEST THREE YEARS OF 1653 01:09:25,360 --> 01:09:28,000 SUPPORT FOR R61 PHASE AND TWO 1654 01:09:28,000 --> 01:09:30,200 YEARS FOR R33 PHASE AND WE HAVE 1655 01:09:30,200 --> 01:09:34,000 FIRST YEAR TO THE CAUSE OF 1656 01:09:34,000 --> 01:09:34,360 3 MILLION. 1657 01:09:34,360 --> 01:09:35,560 SO THE KEY FEATURE OF THE 1658 01:09:35,560 --> 01:09:40,920 PROGRAM THIS IS AS I SAID IT'S 1659 01:09:40,920 --> 01:09:43,640 R61 AND R33 AND WE NEGOTIATED 1660 01:09:43,640 --> 01:09:45,760 THE TERMS OF THE AWARD AND TWO 1661 01:09:45,760 --> 01:09:48,040 PHASES SO THERE'S AN INITIAL R61 1662 01:09:48,040 --> 01:09:49,880 PHASE AND WE FOUND ACTIVITIES 1663 01:09:49,880 --> 01:09:54,760 THAT WE PROVIDE NOVEL INSIGHTS 1664 01:09:54,760 --> 01:09:56,640 REGARDING THE IMMUNO AGAINST OR 1665 01:09:56,640 --> 01:10:00,520 RISE IN ANTIBODIES DERIVATIVES 1666 01:10:00,520 --> 01:10:04,800 AND IF THIS PHASE MOVES IT TO 1667 01:10:04,800 --> 01:10:07,600 R33 PHASE AND THE R33 PHASE PRE 1668 01:10:07,600 --> 01:10:08,640 CLINICAL PRODUCT DEVELOPMENT 1669 01:10:08,640 --> 01:10:11,440 ACTIVITIES TO FACILITATE THE 1670 01:10:11,440 --> 01:10:13,360 TRANSLATION OF THE R61 PHASE 1671 01:10:13,360 --> 01:10:15,760 RESEARCH TO CLINICAL VALUATION 1672 01:10:15,760 --> 01:10:18,120 AND THIS PHASE MAY INCLUDE 1673 01:10:18,120 --> 01:10:20,160 EVALUATION IN MODELS OR 1674 01:10:20,160 --> 01:10:22,680 ASSESSMENT OF THE FEASIBILITY 1675 01:10:22,680 --> 01:10:24,600 RIGHT NOW ALSO WE'RE GOING TO 1676 01:10:24,600 --> 01:10:26,360 ENCOURAGE THE TRANSLATION 1677 01:10:26,360 --> 01:10:28,520 BETWEEN ACADEMIA INDUSTRY AND 1678 01:10:28,520 --> 01:10:29,920 GOVERNMENT BECAUSE WE BELIEVE 1679 01:10:29,920 --> 01:10:31,120 THAT THEY WILL LESS STRENGTHEN 1680 01:10:31,120 --> 01:10:32,800 THE LIKELIHOOD OF SUCCESSFUL 1681 01:10:32,800 --> 01:10:39,520 CLINICAL TRANSLATION. 1682 01:10:39,520 --> 01:10:42,240 THE PANDEMIC ESTABLISHED THIS 1683 01:10:42,240 --> 01:10:43,360 APPROACHES AND PEOPLE 1684 01:10:43,360 --> 01:10:44,800 DEVELOPMENT IN TESTING IT SO WE 1685 01:10:44,800 --> 01:10:46,920 SHOW HERE AS AN EXAMPLE THE 1686 01:10:46,920 --> 01:10:48,920 ACCELERATED TIMELINE FOR THE 1687 01:10:48,920 --> 01:10:52,680 MODERNA mRNA 1/73 AND REALLY 1688 01:10:52,680 --> 01:10:55,160 63 DAYS FROM THE FINALIZE 1689 01:10:55,160 --> 01:10:56,480 SEQUENCE TO THE FORCED 1690 01:10:56,480 --> 01:10:59,520 PARTICIPANT ENROLLING PHASE AT 1691 01:10:59,520 --> 01:11:00,640 CLINICAL TRIAL. 1692 01:11:00,640 --> 01:11:02,960 SO DAY THREE WAS TO LEVERAGE AND 1693 01:11:02,960 --> 01:11:05,840 EXPAND SUCCESSES IN NUCLEO ACID 1694 01:11:05,840 --> 01:11:08,960 PLAS FORM TO THE PACE AND THE 1695 01:11:08,960 --> 01:11:11,760 TEST STRATEGIES FOR PREVENTION 1696 01:11:11,760 --> 01:11:13,760 TREATMENT AND CURE. 1697 01:11:13,760 --> 01:11:16,840 SO THE OBJECTIVES ARE REALLY TO 1698 01:11:16,840 --> 01:11:19,120 AVOID WAY APPROACHES CAN BE USED 1699 01:11:19,120 --> 01:11:21,840 FOR DIFFERENT TYPES OF HIV 1700 01:11:21,840 --> 01:11:24,760 IMMUNO AGAINST AND COMPLEX 1701 01:11:24,760 --> 01:11:27,720 REGIMENTS AND THE AN TA VICE TO 1702 01:11:27,720 --> 01:11:29,200 STATUS AND WE UNDERSTAND THAT IT 1703 01:11:29,200 --> 01:11:30,880 WILL BE UNIQUE REQUIREMENTS OF 1704 01:11:30,880 --> 01:11:33,320 OUR VACCINE AND NEEDS TO BLOCK 1705 01:11:33,320 --> 01:11:35,160 INFECTIONS VERSUS ONE THAT COULD 1706 01:11:35,160 --> 01:11:37,320 BE USED TO TREAT HIV INSPECTED 1707 01:11:37,320 --> 01:11:37,880 INDIVIDUAL. 1708 01:11:37,880 --> 01:11:41,760 THE PLATFORM AND ILLICIT 1709 01:11:41,760 --> 01:11:43,080 STRONGER IMMUNO RESPONSES AND 1710 01:11:43,080 --> 01:11:45,440 CAN SUPPORT THE DELIVERY OF 1711 01:11:45,440 --> 01:11:49,080 MULTIPLE BNABS OR BNAB DERIVE 1712 01:11:49,080 --> 01:11:50,080 DIFFERENCE FOR THE PREVENTION, 1713 01:11:50,080 --> 01:11:52,240 TREATMENT AND CURE SO WE WANTED 1714 01:11:52,240 --> 01:11:54,080 TO EXPLORE WHEN THIS PLATFORM 1715 01:11:54,080 --> 01:11:55,440 CAN DO FOR HIV FIELD AND AT THE 1716 01:11:55,440 --> 01:11:57,440 SAME TIME, WE ALSO KNOWLEDGE HIV 1717 01:11:57,440 --> 01:12:00,440 UNIQUE CHALLENGES. 1718 01:12:00,440 --> 01:12:03,440 SO THESE INCLUDE OF COURSE, THE 1719 01:12:03,440 --> 01:12:04,920 ASTRONOMICAL LIST EQUAL 1720 01:12:04,920 --> 01:12:07,000 WEDNESDAY DIVERSITY AND WE KNOW 1721 01:12:07,000 --> 01:12:11,840 SNIFF AND AIDS SURVEILLANCE SO 1722 01:12:11,840 --> 01:12:13,600 HIV RECOGNIZE SYSTEM WHICH 1723 01:12:13,600 --> 01:12:18,000 RELEASE MEANS THAT THE 1724 01:12:18,000 --> 01:12:19,800 ANTIBODIES ARE UNINFECTION OR 1725 01:12:19,800 --> 01:12:21,920 THROUGH EXPLANATION. 1726 01:12:21,920 --> 01:12:25,360 AND SO BNABs INDEX AND WILL 1727 01:12:25,360 --> 01:12:26,800 LIKELY REQUIRE COMPLEX 1728 01:12:26,800 --> 01:12:28,320 IMMUNIZATION REGIMENTS AND THE 1729 01:12:28,320 --> 01:12:33,480 MAY INCLUDE ACTIVATION AND RATE 1730 01:12:33,480 --> 01:12:35,080 ANTIBODY PRODUCTION. 1731 01:12:35,080 --> 01:12:37,160 ALSO IMMUNE RESPONSES AFTER 1732 01:12:37,160 --> 01:12:39,400 INFECTION ARE NOT EFFECTIVE ON 1733 01:12:39,400 --> 01:12:41,080 COVID-19 INFECTION PROVIDING 1734 01:12:41,080 --> 01:12:42,720 AGAINST REINFECTION SO 1735 01:12:42,720 --> 01:12:44,880 PREVENTION OR CONTROL OF HIV MAY 1736 01:12:44,880 --> 01:12:46,280 REQUIRE SUSTAINED PROTECTIVE 1737 01:12:46,280 --> 01:12:48,760 RESPONSES TO MULTIPLE AND BOTH 1738 01:12:48,760 --> 01:12:52,000 THE BROAD AND NEUTRALIZING AND 1739 01:12:52,000 --> 01:12:57,880 WE NEED PROBABLY ALL THE IMMUNE 1740 01:12:57,880 --> 01:12:58,240 SYSTEM. 1741 01:12:58,240 --> 01:13:00,480 IT'S A WELL-ESTABLISHED 1742 01:13:00,480 --> 01:13:03,600 INFECTION AND OVER ALL WITH HIV 1743 01:13:03,600 --> 01:13:06,120 WE HAVE A ANTIGEN PROBLEM AND 1744 01:13:06,120 --> 01:13:08,360 HIV ANTIGEN FOR VACCINES NEEDS 1745 01:13:08,360 --> 01:13:10,120 TO BE SELECTED SO IN THAT 1746 01:13:10,120 --> 01:13:13,360 REGARD, WE CAUTION THAT IT CAN 1747 01:13:13,360 --> 01:13:17,440 SOLVE THE MENTAL CHALLENGES. 1748 01:13:17,440 --> 01:13:18,760 HOWEVER, THERE ARE 1749 01:13:18,760 --> 01:13:21,680 OPPORTUNITIES, AND YEAH, ON THE 1750 01:13:21,680 --> 01:13:23,720 RIGHT ARE DIFFERENT VACCINE PLAS 1751 01:13:23,720 --> 01:13:25,720 FORMS AND THEY'RE EMPLOYED 1752 01:13:25,720 --> 01:13:27,000 COVID-19 VACCINE WHICH IS ON THE 1753 01:13:27,000 --> 01:13:29,680 ONE WITH THE CIRCLE SO AS I 1754 01:13:29,680 --> 01:13:33,240 SAID, AND REALLY LIKE THE 1755 01:13:33,240 --> 01:13:35,240 PROPERTIES IN ALSO THE 1756 01:13:35,240 --> 01:13:37,120 OPPORTUNITIES AND IT WOULD BE 1757 01:13:37,120 --> 01:13:39,880 PROVEN TO BE SAFE AND RAPID, 1758 01:13:39,880 --> 01:13:41,520 SCALABLE AND LOW COST OF 1759 01:13:41,520 --> 01:13:42,080 MANUFACTURING. 1760 01:13:42,080 --> 01:13:45,080 ALSO ALLOW FOR RAPID UTTER A 1761 01:13:45,080 --> 01:13:47,000 TIVE TESTING ON TA HIGHIZATION 1762 01:13:47,000 --> 01:13:49,600 OF CONCEPT AND VERSATILE AND SO 1763 01:13:49,600 --> 01:13:51,720 THEY CAN ACCOMMODATE DIVERSITY 1764 01:13:51,720 --> 01:13:53,720 AND PUBLICITY OF INSERTS FOR 1765 01:13:53,720 --> 01:13:56,880 BROAD COVERAGE AND IT CAN BE 1766 01:13:56,880 --> 01:13:58,880 SPREAD TO SECRETE AND PROTEINS 1767 01:13:58,880 --> 01:14:02,400 SO WE CAN ALSO DO PRACTICE 1768 01:14:02,400 --> 01:14:03,920 CALECHES TO ADDRESS WHAT IS VERY 1769 01:14:03,920 --> 01:14:05,720 IMPORTANT FOR US, A FIN ACTIVITY 1770 01:14:05,720 --> 01:14:07,880 AND DIVERSITY AND IT STILL NEEDS 1771 01:14:07,880 --> 01:14:10,440 AND IT'S PART OF THE GAP THAT I 1772 01:14:10,440 --> 01:14:13,680 THINK THIS INITIATIVE WANTS TO 1773 01:14:13,680 --> 01:14:14,720 COVER. 1774 01:14:14,720 --> 01:14:21,040 ALSO SELF-ADJUVANTED AND IMMUNO 1775 01:14:21,040 --> 01:14:23,760 GENETIC AND ALSO NO SUPPORT OF 1776 01:14:23,760 --> 01:14:25,520 CENTERS FOR THE DEVELOPMENT OF 1777 01:14:25,520 --> 01:14:28,400 THE MEMORY IN PLASMA CELLS. 1778 01:14:28,400 --> 01:14:30,040 EVEN IF WE ARE ALWAYS ON THE 1779 01:14:30,040 --> 01:14:32,000 LOOK OUT FOR INCREASE THE 1780 01:14:32,000 --> 01:14:35,000 INTARGET CELLS FOR HIV, NEXT. 1781 01:14:35,000 --> 01:14:36,840 SO, ON TOP OF CONTINUED 1782 01:14:36,840 --> 01:14:39,640 OPPORTUNITIES FOR THIS PLATFORM, 1783 01:14:39,640 --> 01:14:42,720 ON TOP YOU SEE THE PLASMA DNA 1784 01:14:42,720 --> 01:14:50,480 ANMODIFIED AND FOR EMERGENCY USE 1785 01:14:50,480 --> 01:14:54,320 FOR VACCINE AND WE LIKE SOME 1786 01:14:54,320 --> 01:14:55,040 DISTINCTIVE REPORTS OF THE 1787 01:14:55,040 --> 01:14:58,000 DIFFERENT FORMS THAT WE THINK 1788 01:14:58,000 --> 01:15:00,280 REALLY CAN BE FOR DESIRE ABLE 1789 01:15:00,280 --> 01:15:01,720 RESPONSE AND YOU KNOW, YOU CAN 1790 01:15:01,720 --> 01:15:04,360 SEE FROM THE PROPERTIES OF THIS 1791 01:15:04,360 --> 01:15:08,000 DIFFERENT PLATFORM, FOR EXAMPLE, 1792 01:15:08,000 --> 01:15:10,160 THE MIX T-CELL AN TOE BODY WITH 1793 01:15:10,160 --> 01:15:13,360 THE DNA OR STRONG ANTIBODIES FOR 1794 01:15:13,360 --> 01:15:15,040 MODIFIED mRNA, STRONGER T 1795 01:15:15,040 --> 01:15:16,640 CELLS FOR MODIFY AND ALSO IN 1796 01:15:16,640 --> 01:15:18,680 TERMS OF STABILITY, WE MAY HAVE 1797 01:15:18,680 --> 01:15:21,480 A HIGH STABILITY FOR DNA OR FOR 1798 01:15:21,480 --> 01:15:26,280 EXAMPLE THE CIRCULAR AREA AT THE 1799 01:15:26,280 --> 01:15:27,920 BOTTOM AND DIFFERENT IN TERMS OF 1800 01:15:27,920 --> 01:15:29,920 SUPPRESSION OF ANTIGEN FOR 1801 01:15:29,920 --> 01:15:32,280 EXAMPLE MOST SUSTAIN EXPRESSION 1802 01:15:32,280 --> 01:15:36,080 WITH THE TRANS-AM NOT FIE SO 1803 01:15:36,080 --> 01:15:37,560 THERE'S A LOT OF PROPERTIES OF 1804 01:15:37,560 --> 01:15:42,880 THIS FORM CAN BE HARNESSED FOR 1805 01:15:42,880 --> 01:15:43,040 HIV. 1806 01:15:43,040 --> 01:15:46,560 WE ARE GOING FOR VERY GOOD 1807 01:15:46,560 --> 01:15:47,640 IMPORTANT OPPORTUNITY IN THIS 1808 01:15:47,640 --> 01:15:48,680 INITIATIVE WOULD COME OUT AND 1809 01:15:48,680 --> 01:15:50,840 THESE ARE REALLY COME FROM 1810 01:15:50,840 --> 01:15:53,680 LEVERAGE OF THE LESSONS FROM RNA 1811 01:15:53,680 --> 01:15:55,720 AND DNA VACCINES AND DIFFERENT 1812 01:15:55,720 --> 01:15:59,120 STAGES AND DEVELOPMENT AND FOR 1813 01:15:59,120 --> 01:16:01,200 SARS-CoV-2, HIV, NON-HIV 1814 01:16:01,200 --> 01:16:02,600 INFECTIOUS DISEASES, CANCER AND 1815 01:16:02,600 --> 01:16:06,320 THE DELIVERY OF MABS. 1816 01:16:06,320 --> 01:16:08,640 TO GIVE YOU AN EXAMPLE IS THE 1817 01:16:08,640 --> 01:16:12,800 DATA FROM THE LANDSCAPE FROM 1818 01:16:12,800 --> 01:16:17,880 SEPTEMBER AND DELIVERING 98 IN 1819 01:16:17,880 --> 01:16:20,480 DEVELOPMENT 24RNA AND 117 1820 01:16:20,480 --> 01:16:23,840 CLINICAL VEMMENTS FOR 41RNA AND 1821 01:16:23,840 --> 01:16:26,720 16DNA SO FOR 24% IN TERMS OF THE 1822 01:16:26,720 --> 01:16:30,720 RNA AND 9% FOR DNA. 1823 01:16:30,720 --> 01:16:31,520 MOST OF THE OPPORTUNITIES WILL 1824 01:16:31,520 --> 01:16:35,760 BE BECAUSE OF A LOT OF VACCINE 1825 01:16:35,760 --> 01:16:37,560 AND REALLY CATCHING THE 1826 01:16:37,560 --> 01:16:37,840 MOMENTUM. 1827 01:16:37,840 --> 01:16:39,240 I THINK IT WILL BE IMPORTANT TO 1828 01:16:39,240 --> 01:16:41,080 SPAN THE POOL OF PLATFORM 1829 01:16:41,080 --> 01:16:42,640 DEVELOPER WORKING WITH HIV 1830 01:16:42,640 --> 01:16:44,640 EXPERTS AND ENCOURAGING A 1831 01:16:44,640 --> 01:16:46,920 COLLABORATION WITH JUSTTATIONAL 1832 01:16:46,920 --> 01:16:49,680 FACTORS FOR THIS INITIATIVE. 1833 01:16:49,680 --> 01:16:51,000 I WANT TO YOU THINK ABOUT THE 1834 01:16:51,000 --> 01:16:53,400 RELATIONSHIP TO OTHER AWARDS AND 1835 01:16:53,400 --> 01:16:56,040 PROGRAMS THAT SUPPORT HIV A WORK 1836 01:16:56,040 --> 01:16:58,200 IN NUCLEO APPROACHES AND MINELY 1837 01:16:58,200 --> 01:17:00,160 FOR HIV PREVENTION AND WE KNOW 1838 01:17:00,160 --> 01:17:03,000 THAT OUR HIV INVESTIGATOR ARE 1839 01:17:03,000 --> 01:17:04,400 INNOVATORS AND VERY RESOURCEFUL 1840 01:17:04,400 --> 01:17:06,440 IN SOME WORKING WITH THE 1841 01:17:06,440 --> 01:17:09,120 PLATFORM BEFORE THE PANDEMIC AND 1842 01:17:09,120 --> 01:17:10,800 WHAT IS REALLY HAPPENING NOW AND 1843 01:17:10,800 --> 01:17:12,120 I PUT EXAMPLES OF THE PROGRAM 1844 01:17:12,120 --> 01:17:14,000 THAT WE SUPPOSE SORTED IT TO 1845 01:17:14,000 --> 01:17:18,120 PROBABLY RECOGNIZE ON THE LEFT 1846 01:17:18,120 --> 01:17:21,240 AND LIKE THE CON SORE SHA FOR 1847 01:17:21,240 --> 01:17:23,280 HIV/AIDS VACCINE DEVELOPMENT AND 1848 01:17:23,280 --> 01:17:28,600 THE HIVRAD, HIV VACCINE AND RO1 1849 01:17:28,600 --> 01:17:31,040 AND IT'S NOT COMPLETE 1850 01:17:31,040 --> 01:17:31,880 COMPREHENSIVE THEY'RE DOING WORK 1851 01:17:31,880 --> 01:17:33,320 BUT WHAT IS HAPPENING RIGHT NOW 1852 01:17:33,320 --> 01:17:36,440 IS REALLY ABOUT COMPARING THE 1853 01:17:36,440 --> 01:17:36,920 SAME CON INFRASTRUCTURE 1854 01:17:36,920 --> 01:17:42,160 DELIVERED BY RNADNA TO 1855 01:17:42,160 --> 01:17:44,720 TRADITIONAL AND NEXT, HOWEVER, 1856 01:17:44,720 --> 01:17:46,640 WE DO THINK THAT OUR PORTFOLIO 1857 01:17:46,640 --> 01:17:49,240 STILL NEEDED TO INCLUDE LIMITED 1858 01:17:49,240 --> 01:17:50,640 NUMBER OF DEVELOPERS SO IF YOU 1859 01:17:50,640 --> 01:17:52,800 GO IN THE TABLE AND LOOK AT 1860 01:17:52,800 --> 01:17:59,160 ORGANIZATIONS BIOTECH INVOLVE 1861 01:17:59,160 --> 01:18:08,640 AND AND THE AND BION PECK AND WE 1862 01:18:08,640 --> 01:18:10,040 HAVE 61 TO SAY BUT THESE ARE THE 1863 01:18:10,040 --> 01:18:13,120 ONLY DEVELOPERS WE'VE BEEN 1864 01:18:13,120 --> 01:18:16,720 WORKING WITH. 1865 01:18:16,720 --> 01:18:23,240 ALSO, THE AND THIS TECHNOLOGY 1866 01:18:23,240 --> 01:18:24,720 WILL BE WITH US FOR A WHILE AND 1867 01:18:24,720 --> 01:18:30,000 WE LIKELY EVOLVE AND IMPROVE SO 1868 01:18:30,000 --> 01:18:31,040 NEXT. 1869 01:18:31,040 --> 01:18:36,000 SO, YEAH, I LIKE THE NIAID DATES 1870 01:18:36,000 --> 01:18:39,200 AND ANTIBODY PIPELINE SO 21 AND 1871 01:18:39,200 --> 01:18:41,240 23 AND WHAT IS HAPPENING NOW IN 1872 01:18:41,240 --> 01:18:43,720 THE CLINICAL GOAL IS REALLY TO 1873 01:18:43,720 --> 01:18:47,040 ESTABLISH THE FEASIBILITY ON THE 1874 01:18:47,040 --> 01:18:52,160 NUCLEAR ACID PLATFORM AND USING 1875 01:18:52,160 --> 01:18:53,960 VACCINES THROUGH HUMAN TESTING 1876 01:18:53,960 --> 01:18:55,880 IN EXPERIMENTAL TRIALS SO HERE 1877 01:18:55,880 --> 01:18:58,360 IF YOU GO TO THE TABLE THERE ARE 1878 01:18:58,360 --> 01:19:02,800 SOME PROTOCOLS FOR EXAMPLE THE 1879 01:19:02,800 --> 01:19:07,160 TESTING NOW MULL POLL 1880 01:19:07,160 --> 01:19:07,840 NATIVE-LIKE TIMERS WHERE WE 1881 01:19:07,840 --> 01:19:10,440 REALLY ARE LOOKING AT IMMUNO 1882 01:19:10,440 --> 01:19:13,520 AGAINST WHEN THEY DELIVER THE 1883 01:19:13,520 --> 01:19:16,880 CASE OF SOL YOU ABLE AND WE ALSO 1884 01:19:16,880 --> 01:19:27,800 HAVE A MULTIPLE IMMU IMMU -- IMO 1885 01:19:35,400 --> 01:19:41,960 AGAINST -- 1886 01:19:41,960 --> 01:19:43,880 AND HOPEFULLY WE START THE CYCLE 1887 01:19:43,880 --> 01:19:46,600 TO GO BACK FOR CLINICAL BECAUSE 1888 01:19:46,600 --> 01:19:48,240 THIS PROBABLY IS A STILL PRODUCT 1889 01:19:48,240 --> 01:19:51,240 AND THIS IS STILL AT THE LEVEL 1890 01:19:51,240 --> 01:19:54,320 EXPERIMENTAL TRIAL OR IF THEY'RE 1891 01:19:54,320 --> 01:19:56,400 PROMISING, GO TO THE PRODUCT. 1892 01:19:56,400 --> 01:19:58,080 AND ALSO I THINK IT'S VERY 1893 01:19:58,080 --> 01:20:00,640 IMPORTANT, LESSON LEARNED IS THE 1894 01:20:00,640 --> 01:20:02,640 PREDICTIVE VALUE OF ANIMAL MODEL 1895 01:20:02,640 --> 01:20:04,920 IS THE SAME REGIMENT TESTED IN 1896 01:20:04,920 --> 01:20:06,440 HUMAN ANIMAL MODELS AND WHEN 1897 01:20:06,440 --> 01:20:10,720 THESE MODELS WILL BE VE VALIDATD 1898 01:20:10,720 --> 01:20:12,040 IT WILL BE EASIER AND FASTER TO 1899 01:20:12,040 --> 01:20:13,680 GO TO THE CLINIC. 1900 01:20:13,680 --> 01:20:19,240 SO HERE ARE EXAMPLES OF SCOPE 1901 01:20:19,240 --> 01:20:24,600 RESEARCH SO TO LOOK AT RESPONSES 1902 01:20:24,600 --> 01:20:26,600 AND WE LIKE STRATEGIES FOR 1903 01:20:26,600 --> 01:20:29,680 STABLATION OF IMMUNOGENIC AND 1904 01:20:29,680 --> 01:20:35,960 INCLUDED BY RNA/DNA NEED TO BE 1905 01:20:35,960 --> 01:20:37,280 GOOD SPIKES AND VARIANTS AND 1906 01:20:37,280 --> 01:20:40,600 EPITOPES AND WE LIKE TO SEE 1907 01:20:40,600 --> 01:20:43,360 DEVELOP OF ANTIGEN AND VACCINE 1908 01:20:43,360 --> 01:20:46,920 AND THIS IS A PLATFORM THAT 1909 01:20:46,920 --> 01:20:50,080 REALLY DO WELL IN UNIVERSITY. 1910 01:20:50,080 --> 01:20:52,920 INVESTIGATE CO-DELIVERY OF 1911 01:20:52,920 --> 01:20:59,120 RNA/DNA IMMUNOGENS AND IN 1912 01:20:59,120 --> 01:21:02,960 ADJUVANT AND MABS AND RND/DNA 1913 01:21:02,960 --> 01:21:06,480 FOR DELIVERY OF COMBINATION WITH 1914 01:21:06,480 --> 01:21:08,640 OTHER PLAS FORMS AND I WOULD 1915 01:21:08,640 --> 01:21:10,840 LIKE TO OPTIMIZE REGIMENTS 1916 01:21:10,840 --> 01:21:11,920 INCLUDING ROUTES OF 1917 01:21:11,920 --> 01:21:14,040 ADMINISTRATION, DOSES, AND 1918 01:21:14,040 --> 01:21:16,640 IMMUNIZATION INTERVALS TO 1919 01:21:16,640 --> 01:21:17,800 INCREASE DURABILITY AND EXPLORE 1920 01:21:17,800 --> 01:21:19,480 SUSTAINED DELIVERY TO SPECIFIC 1921 01:21:19,480 --> 01:21:21,720 CELL TYPES AND TISSUES AND 1922 01:21:21,720 --> 01:21:25,320 OPTIMIZE DELIVERY OF MULTIPLE 1923 01:21:25,320 --> 01:21:33,640 BNABS AND BNAB DERIVATIVE. 1924 01:21:33,640 --> 01:21:40,960 TO USE A SIN T -- AND FOLLOWED Y 1925 01:21:40,960 --> 01:21:44,120 INFUSION AND NON ACTIVITY RESORT 1926 01:21:44,120 --> 01:21:47,480 PURE PLOT FORM IMPROVEMENTS. 1927 01:21:47,480 --> 01:21:49,040 SO, YEAH, WE ARE REALLY THANKFUL 1928 01:21:49,040 --> 01:21:53,920 FOR REVIEWER COMMENTS AND 1929 01:21:53,920 --> 01:21:55,440 STEPHEN WALLACE AND RECOMMEND 1930 01:21:55,440 --> 01:21:57,120 CONCEPTS FOR APPROVAL BUT 1931 01:21:57,120 --> 01:21:59,120 REVIEWER SO THESE CONCEPT IS 1932 01:21:59,120 --> 01:22:01,360 TIMELY AND NEEDED AND THEY 1933 01:22:01,360 --> 01:22:03,480 RECOMMEND MORE ON THE NEED FOR 1934 01:22:03,480 --> 01:22:07,400 INCREASED EFFORTS ON SYNTHETIC 1935 01:22:07,400 --> 01:22:11,480 NUKELY I CAN ACID PLATFORMS AND 1936 01:22:11,480 --> 01:22:22,040 WE BELIEVE REGIMENTS THAT PROMIE 1937 01:22:26,240 --> 01:22:28,360 AND EFFECTING EFFECTIVENESS AND 1938 01:22:28,360 --> 01:22:29,720 DURABILITY AND FILL GAPS IN 1939 01:22:29,720 --> 01:22:33,600 IMMUNE LOGICAL STRUCTURE AND 1940 01:22:33,600 --> 01:22:35,120 FORMULATION PROPERTIES OF THESE 1941 01:22:35,120 --> 01:22:37,360 EVOLVING PLATFORMS FOR IMPROVED 1942 01:22:37,360 --> 01:22:38,440 PERFORMANCE IN THE CONTEXT OF 1943 01:22:38,440 --> 01:22:44,520 HIV AND THE UNIQUE CHALLENGES. 1944 01:22:44,520 --> 01:22:46,440 ALSO, WE THANK FOR THE QUESTION 1945 01:22:46,440 --> 01:22:48,880 ABOUT ADDRESSING EQUITY 1946 01:22:48,880 --> 01:22:51,280 DIVERSITY OF FILING FOR THIS 1947 01:22:51,280 --> 01:22:53,040 INITIATIVE AND ACCESS TO THE 1948 01:22:53,040 --> 01:22:54,120 PLATFORM AND VACCINE DEVELOPMENT 1949 01:22:54,120 --> 01:22:58,840 AND THIS INITIATIVE. 1950 01:22:58,840 --> 01:23:00,480 RERESPECT EQUITY AND DIVERSITY 1951 01:23:00,480 --> 01:23:02,400 TO LEVEL OF SCIENCE AND ACCESS 1952 01:23:02,400 --> 01:23:07,080 AND CDA AND PRODUCTS GLOBALLY 1953 01:23:07,080 --> 01:23:07,240 AND. 1954 01:23:07,240 --> 01:23:08,720 THERE ARE A LOT OF ACTIVITIES SO 1955 01:23:08,720 --> 01:23:12,040 WE WANT YOU TO SPEND A LITTLE 1956 01:23:12,040 --> 01:23:13,520 BIT FEW MORE TO GO A LITTLE BIT 1957 01:23:13,520 --> 01:23:16,640 MAYBE REPEATING ALSO WHAT WE'VE 1958 01:23:16,640 --> 01:23:21,600 BEEN SAYING THIS MORNING SO NEXT 1959 01:23:21,600 --> 01:23:21,800 SLIDE. 1960 01:23:21,800 --> 01:23:24,320 SO MAP EQUITY AND DIVERSITY IS 1961 01:23:24,320 --> 01:23:26,360 WE SAID IS PREPARING STRATEGIC 1962 01:23:26,360 --> 01:23:32,160 PLAN FOR DIVERSITY AND THE DEIAO 1963 01:23:32,160 --> 01:23:34,200 ADDRESS THIS CONCEPT TO 1964 01:23:34,200 --> 01:23:36,720 WORKFORCE STRUCTURE, CULTURE AND 1965 01:23:36,720 --> 01:23:39,880 THERE'S SUPPORT AND DID FAUCI 1966 01:23:39,880 --> 01:23:42,840 SAID IN 2021 NIAID ESTABLISHED A 1967 01:23:42,840 --> 01:23:44,480 DIVERSITY COUNCIL TO FIND WAYS 1968 01:23:44,480 --> 01:23:46,640 FOR NIAID FUNDED RESEARCH TO THE 1969 01:23:46,640 --> 01:23:48,640 WAYEST IMPACT POSSIBLE 1970 01:23:48,640 --> 01:23:49,840 ESPECIALLY FOR THOSE MOST 1971 01:23:49,840 --> 01:23:52,640 AFFECTED BY DISEASE. 1972 01:23:52,640 --> 01:23:54,320 SO THEY WILL TAKE ACCESS OF THE 1973 01:23:54,320 --> 01:23:56,880 VACCINE IS BEEN IN THE PUBLIC 1974 01:23:56,880 --> 01:23:58,560 EYE ESPECIALLY ABOUT THE 1975 01:23:58,560 --> 01:24:00,440 DISADVANTAGE A PLATFORM DURING 1976 01:24:00,440 --> 01:24:02,320 THE SARS-CoV-2 PANDEMIC SO WE 1977 01:24:02,320 --> 01:24:04,240 HAVE TO SAY THESE ARE GRANTS AND 1978 01:24:04,240 --> 01:24:07,840 IT'S LIMITED BY THE ACT AND IT 1979 01:24:07,840 --> 01:24:09,920 ENABLES UNIVERSITY NON-PROFIT 1980 01:24:09,920 --> 01:24:13,440 AND MORE BUSINESSES TO OWN, 1981 01:24:13,440 --> 01:24:13,920 PATENT AND COMMERCIALIZE 1982 01:24:13,920 --> 01:24:15,120 INVENTIONS DEVELOPMENT UNDER 1983 01:24:15,120 --> 01:24:17,040 FEDERALLY FUNDED RESEARCH. 1984 01:24:17,040 --> 01:24:18,360 HOWEVER, WE ARE PROUD TO SAY 1985 01:24:18,360 --> 01:24:20,600 THAT OUR HIV SCIENTISTS HAVE 1986 01:24:20,600 --> 01:24:21,920 BEEN SENSITIVE TO THE NEEDS OF 1987 01:24:21,920 --> 01:24:23,720 PEOPLE IN THE DEVELOPING WORLD 1988 01:24:23,720 --> 01:24:26,760 AND ARE ENCOURAGED TO WORK WITH 1989 01:24:26,760 --> 01:24:28,160 LOW/MIDDLE INCOME COUNTRY 1990 01:24:28,160 --> 01:24:29,760 SCIENTISTS TO SHARE TECHNOLOGIES 1991 01:24:29,760 --> 01:24:31,160 BUT OF COURSE INVESTIGATORS 1992 01:24:31,160 --> 01:24:35,520 CANNOT DO IS THE INTELLECTUAL 1993 01:24:35,520 --> 01:24:37,120 PROPERTIES FROM BIO TECHS AS AN 1994 01:24:37,120 --> 01:24:39,800 EXAMPLE GIVEN TODAY FROM THE 1995 01:24:39,800 --> 01:24:42,600 GIVE BACK IS THE WORK THAT WE 1996 01:24:42,600 --> 01:24:45,920 DID SAY UNDER THE APCB PROGRAM 1997 01:24:45,920 --> 01:24:49,320 ARE WORKING TO TRANSFER THE HOW 1998 01:24:49,320 --> 01:24:51,240 TO SOUTH AFRICA TEAMS IN THE 1999 01:24:51,240 --> 01:24:55,600 W.H.O. AND HAVE THE RARE 2000 01:24:55,600 --> 01:24:58,360 INVESTIGATOR IN THI THAILAND. 2001 01:24:58,360 --> 01:24:59,640 THIS IS THE END OF MY 2002 01:24:59,640 --> 01:25:00,320 PRESENTATION. 2003 01:25:00,320 --> 01:25:02,040 PLEASE, ANY QUESTIONS, THANK 2004 01:25:02,040 --> 01:25:02,200 YOU. 2005 01:25:02,200 --> 01:25:04,800 >> THANK YOU, VERY MUCH. 2006 01:25:04,800 --> 01:25:08,080 VERY NICE PRESENTATION. 2007 01:25:08,080 --> 01:25:14,400 VERY EXCITING PROGRESS IN THIS 2008 01:25:14,400 --> 01:25:17,440 AREA. 2009 01:25:17,440 --> 01:25:19,440 QUESTIONS. 2010 01:25:19,440 --> 01:25:21,040 >> I HAVE A CLARIFYING QUESTION. 2011 01:25:21,040 --> 01:25:22,680 YOU ARE GOING TO DO ACTIVE AND 2012 01:25:22,680 --> 01:25:25,280 PASSIVE IMMUNIZATION IN THIS 2013 01:25:25,280 --> 01:25:25,560 MECHANISM. 2014 01:25:25,560 --> 01:25:26,480 >> YOU ARE CORRECT, YES. 2015 01:25:26,480 --> 01:25:27,640 >> AND I GUESS THAT'S FINE. 2016 01:25:27,640 --> 01:25:34,800 I MEAN, THEY'RE BOTH IMPORTANT. 2017 01:25:34,800 --> 01:25:36,400 >> WE HAD THIS WORKSHOP IN MAY 2018 01:25:36,400 --> 01:25:39,360 ABOUT THE DEVELOPMENT OF 2019 01:25:39,360 --> 01:25:41,400 ANTIBODY AND WE HAD A SESSION ON 2020 01:25:41,400 --> 01:25:43,080 PLATFORM DEVELOPMENT AND 2021 01:25:43,080 --> 01:25:45,600 DELIVERY AND REALLY IT WAS A 2022 01:25:45,600 --> 01:25:46,400 GAP. 2023 01:25:46,400 --> 01:25:49,080 THE DELIVERY OF ANTIBODIES SO WE 2024 01:25:49,080 --> 01:25:53,200 SAW IT AS AN OPPORTUNITY AND 2025 01:25:53,200 --> 01:25:55,320 HERE TO (INAUDIBLE) BECAUSE IT'S 2026 01:25:55,320 --> 01:26:00,320 REALLY MORE GLOBAL ACCESS OF 2027 01:26:00,320 --> 01:26:00,520 THIS -- 2028 01:26:00,520 --> 01:26:02,720 >> I WONDER, I MEAN, I GUESS 2029 01:26:02,720 --> 01:26:04,640 IT'S TOO LATE TO CHANGE THE 2030 01:26:04,640 --> 01:26:08,160 TITLE BUT, TO INCLUDE THAT 2031 01:26:08,160 --> 01:26:08,560 ASPECT. 2032 01:26:08,560 --> 01:26:09,200 BUT ANYWAY. 2033 01:26:09,200 --> 01:26:10,360 BECAUSE THERE MAY BE A LOT OF 2034 01:26:10,360 --> 01:26:13,480 PEOPLE WHO WON'T EVEN KNOW ABOUT 2035 01:26:13,480 --> 01:26:13,640 IT. 2036 01:26:13,640 --> 01:26:17,800 >> YEAH. 2037 01:26:17,800 --> 01:26:18,480 OK. 2038 01:26:18,480 --> 01:26:20,480 YEAH. 2039 01:26:20,480 --> 01:26:21,640 WE'VE BEEN VAGUE IN OUR TITLE. 2040 01:26:21,640 --> 01:26:21,840 YEAH. 2041 01:26:21,840 --> 01:26:23,920 AS A PLATFORM BUT YEAH WE WILL 2042 01:26:23,920 --> 01:26:25,160 RECONSIDER THAT, THANK YOU. 2043 01:26:25,160 --> 01:26:33,880 >> OK. 2044 01:26:33,880 --> 01:26:35,040 LET ME ASK PEOPLE TO VOTE. 2045 01:26:35,040 --> 01:26:36,080 WE HAVE A COUPLE OF MINUTES IF 2046 01:26:36,080 --> 01:26:46,520 WE HAVE ANOTHER QUESTION. 2047 01:26:47,960 --> 01:26:50,520 >> THANK YOU Dr. MALASPINA. 2048 01:26:50,520 --> 01:26:51,200 WE WILL CONTINUE. 2049 01:26:51,200 --> 01:26:52,360 WE'RE A LITTLE BIT AHEAD OF 2050 01:26:52,360 --> 01:26:55,080 SCHEDULE WHICH IS ALWAYS NICE. 2051 01:26:55,080 --> 01:27:03,080 MAYBE WE CAN BRING UP THE NEXT 2052 01:27:03,080 --> 01:27:03,680 CONCEPT. 2053 01:27:03,680 --> 01:27:06,560 SO, THIS IS ENTITLED RATIONAL 2054 01:27:06,560 --> 01:27:08,400 SYSTEMATIC CHARACTERIZATION AND 2055 01:27:08,400 --> 01:27:13,720 SELECTION OF ADD YOU VENT WILL 2056 01:27:13,720 --> 01:27:17,240 BE RECOLLECTED BY Dr. MILTON 2057 01:27:17,240 --> 01:27:17,480 MACIEL. 2058 01:27:17,480 --> 01:27:18,880 >> I HOPE YOU CAN HEAR ME. 2059 01:27:18,880 --> 01:27:19,520 IS THAT OK? 2060 01:27:19,520 --> 01:27:20,560 >> YES, GREAT. 2061 01:27:20,560 --> 01:27:21,200 >> GREAT. 2062 01:27:21,200 --> 01:27:22,800 THANK YOU, SO GOOD AFTERNOON FOR 2063 01:27:22,800 --> 01:27:24,880 THOSE IN THE WEST COAST AND GOOD 2064 01:27:24,880 --> 01:27:26,440 MORNING FOR THOSE IN THE WEST 2065 01:27:26,440 --> 01:27:27,560 COAST. 2066 01:27:27,560 --> 01:27:30,360 MY NAME IS MILTON MACIEL FROM 2067 01:27:30,360 --> 01:27:31,840 THE DIVISION OF AIDS AND I'M 2068 01:27:31,840 --> 01:27:36,040 GOING TO INTRODUCE THE RATIONAL 2069 01:27:36,040 --> 01:27:37,600 SYSTEMATIC CHARACTERIZATION 2070 01:27:37,600 --> 01:27:43,720 SELECTION OF ADJUVANTS FOR HIV 2071 01:27:43,720 --> 01:27:44,920 VACCINE CANDIDATES. 2072 01:27:44,920 --> 01:27:51,400 TO OPTIMIZE HIV ADJUVANTS FOR 2073 01:27:51,400 --> 01:27:55,600 DURABILITY AND AND MAGNITUDE OF 2074 01:27:55,600 --> 01:28:01,680 HIV VACCINES -- AND BASED ON THE 2075 01:28:01,680 --> 01:28:03,040 DESIRE IN LARGE PROFOUND AND 2076 01:28:03,040 --> 01:28:05,080 THIS IS A NEW MECHANISM AND IF 2077 01:28:05,080 --> 01:28:06,600 IT'S A BROAD AGENCY ANNOUNCEMENT 2078 01:28:06,600 --> 01:28:08,240 WITH THE DURATION OF FIVE YEARS 2079 01:28:08,240 --> 01:28:10,640 AND WE HOPE THAT WE EXPECT TO 2080 01:28:10,640 --> 01:28:17,640 AWARD ONE CONTRACT. 2081 01:28:17,640 --> 01:28:21,040 SO I'LL START BY BRIEFLY 2082 01:28:21,040 --> 01:28:23,320 REVIEWING NIAID APPROACH TO 2083 01:28:23,320 --> 01:28:26,560 SUPPORT INVESTIGATE AND ADJUVANT 2084 01:28:26,560 --> 01:28:27,320 FOR VACCINE. 2085 01:28:27,320 --> 01:28:30,760 IN 2018, THIS STRATEGIC PLAN 2086 01:28:30,760 --> 01:28:32,400 DEFINED THREE MAJOR AREAS THAT 2087 01:28:32,400 --> 01:28:34,080 NEEDED TO BE ADDRESSED. 2088 01:28:34,080 --> 01:28:36,320 FIRST, FUNDAMENTAL IMMUNOLOGY 2089 01:28:36,320 --> 01:28:42,520 AND ADJUVANT AND DEVELOPMENT IN 2090 01:28:42,520 --> 01:28:43,920 CLIN TAL A VESMENT AND THIRD 2091 01:28:43,920 --> 01:28:48,160 CLINICAL EVALUATION OF 2092 01:28:48,160 --> 01:28:49,120 ADJUVANTED VACCINES. 2093 01:28:49,120 --> 01:28:50,920 SUPPORT SIDE BY SIDE COMPARISON 2094 01:28:50,920 --> 01:28:52,760 IN COMBINATION WITH CLINICAL 2095 01:28:52,760 --> 01:28:54,960 RELEVANT VACCINES AND AG 2096 01:28:54,960 --> 01:28:55,560 PLATFORMS. 2097 01:28:55,560 --> 01:28:56,720 ESTABLISH BOTH SIS FEMALE I CAN 2098 01:28:56,720 --> 01:28:58,880 AND TISSUE-SPECIFIC IMMUNE 2099 01:28:58,880 --> 01:29:02,400 LOGICAL PROFILES AND EMPLOY AND 2100 01:29:02,400 --> 01:29:06,360 THE CALLS IN ENDJOINED ASSAYS 2101 01:29:06,360 --> 01:29:08,600 FOR EXPERIMENT AND CONTINUES 2102 01:29:08,600 --> 01:29:11,520 SCREEN POTENTIAL NEW ADJUVANTS, 2103 01:29:11,520 --> 01:29:14,120 NEXT SLIDE. 2104 01:29:14,120 --> 01:29:14,520 PLEASE. 2105 01:29:14,520 --> 01:29:17,920 THIS TIMELINE SUMMARIZED TWO 2106 01:29:17,920 --> 01:29:19,360 DECADES OF INITIATIVES 2107 01:29:19,360 --> 01:29:20,760 PHOTOGRAPHICKED ON THE 2108 01:29:20,760 --> 01:29:24,680 DEVELOPMENT OF ADJUVANT BUT IT'S 2109 01:29:24,680 --> 01:29:25,880 NOT EXHAUSTINGED LIST. 2110 01:29:25,880 --> 01:29:27,600 AS YOU CAN SEE BELOW THE 2111 01:29:27,600 --> 01:29:28,960 TIMELINE, THE DIVISION OF 2112 01:29:28,960 --> 01:29:31,680 ALLERGY AND KNOWLEDGE OF DATE 2113 01:29:31,680 --> 01:29:33,800 HAS MAINTAINED OVER THE YEARS. 2114 01:29:33,800 --> 01:29:35,120 A LARGE PORTFOLIO FOR THE 2115 01:29:35,120 --> 01:29:41,040 PROGRAMS FOCUS ON ADJUVANT AND 2116 01:29:41,040 --> 01:29:49,280 IN 2021, THE COMPARE ON BA8 FOR 2117 01:29:49,280 --> 01:29:52,400 ALLERGY, CANCER, AND SEVERAL 2118 01:29:52,400 --> 01:29:54,320 DISEASES FORMALLY EXCLUDING TB 2119 01:29:54,320 --> 01:30:00,040 WHICH HAS ITS OWN PROGRAM. 2120 01:30:00,040 --> 01:30:01,320 OUR DIVISION DAIDS JOINED FORCES 2121 01:30:01,320 --> 01:30:10,080 WITH DD AYE T INCLUDE ADJUVANTSR 2122 01:30:10,080 --> 01:30:10,960 IMMUNOGENS. 2123 01:30:10,960 --> 01:30:13,040 ON THE UPPER SIDE OF THIS 2124 01:30:13,040 --> 01:30:15,840 TIMELINE, YOU CAN SEE ACTIVITIES 2125 01:30:15,840 --> 01:30:17,160 FOCUS ODD ANJOU VANT SUPPORT BY 2126 01:30:17,160 --> 01:30:18,760 DATES AND I ADDED THE REFERENCE 2127 01:30:18,760 --> 01:30:24,520 TO THE SEMINAL HVTN 137 PHASE 1 2128 01:30:24,520 --> 01:30:26,680 STUDY ON THE EVALUATION OF THREE 2129 01:30:26,680 --> 01:30:31,120 DIFFERENT TLR AGONIST WITHAL UM 2130 01:30:31,120 --> 01:30:34,360 OR THE BG505SOSIP WHICH I WILL 2131 01:30:34,360 --> 01:30:36,520 SHOW LATER ON IN MORE DETAILS 2132 01:30:36,520 --> 01:30:37,600 ABOUT. 2133 01:30:37,600 --> 01:30:39,840 NOW, NOT SHOWING THIS TIMELINE, 2134 01:30:39,840 --> 01:30:41,520 I THINK WE'LL TRY DEVELOPMENTS 2135 01:30:41,520 --> 01:30:44,600 AND SOME OF WHICH DO INCLUDE A 2136 01:30:44,600 --> 01:30:47,840 FEW ADJUVANTS AND NON HUMAN 2137 01:30:47,840 --> 01:30:49,360 PRIME AT STUDIES WITH OUR 2138 01:30:49,360 --> 01:30:50,440 CLINICAL RESEARCH AND 2139 01:30:50,440 --> 01:30:53,080 DEVELOPMENT BRANCH INTENDED TO 2140 01:30:53,080 --> 01:30:55,320 MIRROR THE STUDY. 2141 01:30:55,320 --> 01:30:59,600 HOWEVER, UNTIL NOW, DAIT HAS NO 2142 01:30:59,600 --> 01:31:02,520 MECHANISM FOCUSED ON THE PRE 2143 01:31:02,520 --> 01:31:05,360 CLINICAL DEVELOPMENT OF 2144 01:31:05,360 --> 01:31:08,800 ADJUVANTS FORMULATIONS WHICH IS 2145 01:31:08,800 --> 01:31:14,120 A GAP WE HOPE FY24 CLINICAL WILL 2146 01:31:14,120 --> 01:31:14,320 COVER. 2147 01:31:14,320 --> 01:31:16,240 I WILL NOW SHOW YOU SOME 2148 01:31:16,240 --> 01:31:17,120 CONCLUSIONS AND HIGHLIGHTS OF 2149 01:31:17,120 --> 01:31:22,040 THE RECENT WORKSHOP RECORD BY 2150 01:31:22,040 --> 01:31:25,240 DAIDS AND THE HIV VACCINE BY ADD 2151 01:31:25,240 --> 01:31:27,040 VIEW VARIANT WHICH THE SUMMARY 2152 01:31:27,040 --> 01:31:30,480 IS PREPARED FOR PUB LA CAME IT'S 2153 01:31:30,480 --> 01:31:31,520 WELL DEVELOPED THE DEVELOPMENT 2154 01:31:31,520 --> 01:31:34,840 OF EFFECTIVE VACCINES FORMIDABLE 2155 01:31:34,840 --> 01:31:35,160 TASK. 2156 01:31:35,160 --> 01:31:36,600 AND AMONG THE UNIQUE CHALLENGES 2157 01:31:36,600 --> 01:31:38,520 WE ARE FACED BY THE LACK OF 2158 01:31:38,520 --> 01:31:42,000 EVIDENCE FOR BROAD NATIONAL 2159 01:31:42,000 --> 01:31:44,240 PROTECTION AND CONSEQUENTLY NO 2160 01:31:44,240 --> 01:31:45,160 DEFINED CORRELATES OF IMMUNITY 2161 01:31:45,160 --> 01:31:46,880 IN OUR PROTECTION AND THE LACK 2162 01:31:46,880 --> 01:31:50,760 OF A HUMAN CHALLENGED MODEL AND 2163 01:31:50,760 --> 01:31:53,920 IN PERFECT ANIMAL MODELS IN 2164 01:31:53,920 --> 01:31:58,680 VACCINES AND THERAPY. 2165 01:31:58,680 --> 01:32:00,000 AND AT THE SAME TIME, OUR 2166 01:32:00,000 --> 01:32:02,480 CURRENT UNDERSTANDING POINTS OUT 2167 01:32:02,480 --> 01:32:04,120 THAT THE HIV VACCINE WILL HAVE 2168 01:32:04,120 --> 01:32:07,320 TO PROPERLY MOBILIZE A IMMUNE 2169 01:32:07,320 --> 01:32:09,800 SYSTEM TO ACTIVATE THE IMMUNE 2170 01:32:09,800 --> 01:32:16,360 RESPONSE WHICH HAS TO BE BY MOT' 2171 01:32:16,360 --> 01:32:20,600 MODEL AND TCL RESPONSE. 2172 01:32:20,600 --> 01:32:21,800 WE BELIEVE THAT INVESTIGATION OF 2173 01:32:21,800 --> 01:32:26,640 THE IMMUNOGENS AND ADJUVANTS IN 2174 01:32:26,640 --> 01:32:30,240 COMBINATION IMPROVE THE NEW 2175 01:32:30,240 --> 01:32:36,440 PLATFORMS OF PIVOTAL TO SUPPORT 2176 01:32:36,440 --> 01:32:37,080 THE VACCINES. 2177 01:32:37,080 --> 01:32:39,120 BEING THAT WAY, THE INITIATIVE 2178 01:32:39,120 --> 01:32:41,400 WILL SUPPORT BIO MEMBER CAL AND 2179 01:32:41,400 --> 01:32:44,040 IMMUNE LOGICAL SYSTEM AND IN 2180 01:32:44,040 --> 01:32:50,680 SCREEN OF HIV IMMUNOGENS AND 2181 01:32:50,680 --> 01:32:52,720 ESTABLISH WITH THE GENERATE 2182 01:32:52,720 --> 01:32:55,280 IMPORTANT KNOWLEDGE TO FURTHER 2183 01:32:55,280 --> 01:32:58,640 DEVELOP THE VACCINE. 2184 01:32:58,640 --> 01:33:00,040 DEVELOPED IN THE PARAMETER FOR 2185 01:33:00,040 --> 01:33:03,160 THIS INITIATIVE, WE SPOKE WITH 2186 01:33:03,160 --> 01:33:05,520 HIV IMMUNO AGAIN AND ADJUVANT 2187 01:33:05,520 --> 01:33:09,040 DEVELOPERS ALIKE INCLUDING OUR 2188 01:33:09,040 --> 01:33:13,720 COLLEAGUES FROM DAIT TO EXPAND 2189 01:33:13,720 --> 01:33:20,800 THE NEGOTIATION THEY CHOSE 2190 01:33:20,800 --> 01:33:22,840 ADJUVANTS BASED ON CONVENIENCE 2191 01:33:22,840 --> 01:33:25,040 OR BIOCHEMICAL, BIO PHYSICAL AND 2192 01:33:25,040 --> 01:33:26,960 IMMUNE LOGICAL COMPARISONS SO 2193 01:33:26,960 --> 01:33:29,120 NEW ADJUVANTS HAVE TESTED FOR 2194 01:33:29,120 --> 01:33:32,280 CLINICAL AND ARE IN CLINICAL 2195 01:33:32,280 --> 01:33:32,520 TRIALS. 2196 01:33:32,520 --> 01:33:34,400 AT THE SAME TIME, ADD VIEW 2197 01:33:34,400 --> 01:33:35,040 DECONGESTANT DEVELOPERS ARE 2198 01:33:35,040 --> 01:33:40,120 RELUCTANT TO SHARE THE 2199 01:33:40,120 --> 01:33:40,840 PROVINCE. 2200 01:33:40,840 --> 01:33:42,360 THOUGH UNDER FIRE FOR 2201 01:33:42,360 --> 01:33:43,000 PRECONCEIVED BY PLIGHT. 2202 01:33:43,000 --> 01:33:45,080 AND UNFORTUNATELY, BOTH SEVERAL 2203 01:33:45,080 --> 01:33:46,640 NEW ADJUVANTS ARE UNDER 2204 01:33:46,640 --> 01:33:47,520 INVESTIGATION BY DIFFERENT 2205 01:33:47,520 --> 01:33:49,600 COMPANIES FOR ALL THE DISEASE 2206 01:33:49,600 --> 01:33:53,040 AND HIV/AIDS PRODUCTS ARE A 2207 01:33:53,040 --> 01:33:56,040 HIGH-RISK AND NOT TAKEN. 2208 01:33:56,040 --> 01:33:57,920 SO NEXT, THE QUESTION IS, HOW 2209 01:33:57,920 --> 01:34:01,080 CAN WE ENGAGE FRUITFUL 2210 01:34:01,080 --> 01:34:05,120 COLLABORATION BETWEEN HIV 2211 01:34:05,120 --> 01:34:06,600 IMMUNOGEN AND HIV DEVELOPERS. 2212 01:34:06,600 --> 01:34:08,640 PART OF THE ANSWER IS TO NETWORK 2213 01:34:08,640 --> 01:34:09,360 THE DIFFERENT GROUPS. 2214 01:34:09,360 --> 01:34:10,880 THE WORKSHOP THAT I MENTIONED A 2215 01:34:10,880 --> 01:34:13,160 WHILE AGO, JUMP STARTED SOME 2216 01:34:13,160 --> 01:34:14,800 CONVERSATIONS BETWEEN THOSE 2217 01:34:14,800 --> 01:34:15,680 GROUPS. 2218 01:34:15,680 --> 01:34:18,440 ALSO, HAVING SET ASIDE FUNDS AS 2219 01:34:18,440 --> 01:34:20,480 THE INITIATIVE IS AN IMPORTANT 2220 01:34:20,480 --> 01:34:22,240 COMPONENT OF THIS ANSWER AS WELL 2221 01:34:22,240 --> 01:34:25,000 AS ENGAGE SMALLER START UP 2222 01:34:25,000 --> 01:34:26,520 ADJUVANT DEVELOPERS WHICH IN THE 2223 01:34:26,520 --> 01:34:29,200 LAST DECADE, BUT ALSO DUE TO THE 2224 01:34:29,200 --> 01:34:30,520 SARS-CoV-2 PANDEMIC EXPANDED 2225 01:34:30,520 --> 01:34:32,600 THE PORTFOLIO AND FINALLY, 2226 01:34:32,600 --> 01:34:34,040 PROVIDE GUIDANCE OF STATE OF THE 2227 01:34:34,040 --> 01:34:37,600 ART ASSAYS, RELEVANT TO 2228 01:34:37,600 --> 01:34:39,400 ASSESSING IMMUNO AND HALF THE 2229 01:34:39,400 --> 01:34:42,240 PANEL OF EXPERTISE OF HIV 2230 01:34:42,240 --> 01:34:45,240 IMMUNOGEN DEVELOPERS. 2231 01:34:45,240 --> 01:34:47,760 I WANT TO SHARE ONE EXAMPLE WHY 2232 01:34:47,760 --> 01:34:51,360 IT'S IMPORTANT TO PROPERLY 2233 01:34:51,360 --> 01:34:53,040 ASSESS IMMUNOGEN FOR PURVIEWING 2234 01:34:53,040 --> 01:34:55,280 PRE CLINICAL DEVELOPMENT. 2235 01:34:55,280 --> 01:34:59,120 THE FORMULATION OF ADJUVANT AND 2236 01:34:59,120 --> 01:35:00,720 IMMUNOGEN, SHOULD NOT PHYSICALLY 2237 01:35:00,720 --> 01:35:03,960 DAMAGE THE IMMUNOGEN OR IMPEDE 2238 01:35:03,960 --> 01:35:08,440 ITS ABILITY TO PRESENT EPITOPES. 2239 01:35:08,440 --> 01:35:10,440 IT INVESTIGATED HOW SEVERAL 2240 01:35:10,440 --> 01:35:13,240 ADJUVANTS OF VARIOUS COMPETITION 2241 01:35:13,240 --> 01:35:20,320 EFFECTED EPITOPES ON TIMERS AND 2242 01:35:20,320 --> 01:35:30,880 WHILE MOST OF THE TASK AS SHOWN, 2243 01:35:34,560 --> 01:35:39,680 A CPG ADJUVANT, LED TO 2244 01:35:39,680 --> 01:35:44,000 CONCLUSION OF THE TIMER FOR THE 2245 01:35:44,000 --> 01:35:47,840 PGT145. 2246 01:35:47,840 --> 01:35:49,120 WITH THE LOWER BLUE-LINE 2247 01:35:49,120 --> 01:35:54,440 HIGHLIGHTED BY THE RED ARROW IN 2248 01:35:54,440 --> 01:35:56,400 THIS BOX. 2249 01:35:56,400 --> 01:35:58,720 FINALLY, I WANT TO PREVIOUSLY 2250 01:35:58,720 --> 01:36:01,920 DISCUSS THE PHASE 1 CLINICAL 2251 01:36:01,920 --> 01:36:03,720 TRIAL PGT145. 2252 01:36:03,720 --> 01:36:06,040 ON THE TABLE ON THE LEFT SHOWS 2253 01:36:06,040 --> 01:36:06,960 THE TRIAL DESIGN. 2254 01:36:06,960 --> 01:36:09,360 THE UPPER PART OF THE TABLE, 2255 01:36:09,360 --> 01:36:15,840 LOOK AT TWO DOSES OF THE TLR78 2256 01:36:15,840 --> 01:36:21,080 GIVEN INTER MUSCULARLY WITH THE 2257 01:36:21,080 --> 01:36:23,040 664GP140 AND THE RESORTS FROM 2258 01:36:23,040 --> 01:36:24,600 PART A INDICATED IT WAS SAFE TO 2259 01:36:24,600 --> 01:36:27,360 PROCEED TO PART B WITH FIVE 2260 01:36:27,360 --> 01:36:29,480 MICRO GRAMS OF THE ANTI-VANT 2261 01:36:29,480 --> 01:36:34,600 WHERE IT'S COMPARED TO TWO OTHER 2262 01:36:34,600 --> 01:36:41,280 RECEPTORS AND THE COMPARE TO BE. 2263 01:36:41,280 --> 01:36:41,680 NEXT. 2264 01:36:41,680 --> 01:36:44,160 THE TABLE WE CAN SEE ON THE 2265 01:36:44,160 --> 01:36:46,200 UPPER-RIGHT, YOU CAN SEE RESULTS 2266 01:36:46,200 --> 01:36:47,960 FROM PART A WHICH INDICATES THAT 2267 01:36:47,960 --> 01:36:55,440 THE FIVE MICRO GRAMS OF 3M052 2268 01:36:55,440 --> 01:36:59,360 ADJUVANTS IN SOME PARTICIPANTS 2269 01:36:59,360 --> 01:37:04,200 ALSO, BOTH DOSE OF THE EDGE 2270 01:37:04,200 --> 01:37:08,720 T-CELL ABLE TO SECRETE IN ALL 2271 01:37:08,720 --> 01:37:11,920 IL2 WITH IN VITRO WITH THE 2272 01:37:11,920 --> 01:37:12,320 ANTIGEN. 2273 01:37:12,320 --> 01:37:15,120 TWO MAIN POINTS WITH THIS LIGHT 2274 01:37:15,120 --> 01:37:16,560 ARM WHILE THIS IS A VERY 2275 01:37:16,560 --> 01:37:18,600 IMPORTANT CLINICAL TRIAL, IT'S 2276 01:37:18,600 --> 01:37:21,480 LIMITED COMPARE ONLY A FEW 2277 01:37:21,480 --> 01:37:23,400 ADJUVANTS WHICH UNDERSTANDABLE 2278 01:37:23,400 --> 01:37:25,040 GIVEN ITS COMPLEXITY AND COST. 2279 01:37:25,040 --> 01:37:29,840 BUT MAYBE MORE IMPORTANTLY, 2280 01:37:29,840 --> 01:37:32,960 WHILE THE 3M052 THAT'S POSITIVE 2281 01:37:32,960 --> 01:37:34,640 RESPONSE, THOSE PRELIMINARY 2282 01:37:34,640 --> 01:37:36,280 RESULTS, BEFORE PART B IS 2283 01:37:36,280 --> 01:37:37,440 COMPLETED, HAVE ALREADY 2284 01:37:37,440 --> 01:37:38,360 MOTIVATED ALL THE CLINICAL 2285 01:37:38,360 --> 01:37:42,520 TRIALS TO ADOPT THESE ADJUVANTS 2286 01:37:42,520 --> 01:37:44,440 AND THIS IS SORT OF IN YOUNG 2287 01:37:44,440 --> 01:37:47,280 EXAMPLE OF HOW ADJUVANT 2288 01:37:47,280 --> 01:37:49,480 ASSESSMENTS ARE UNDERTAKEN. 2289 01:37:49,480 --> 01:37:52,640 NEXT SLIDE, PLEASE. 2290 01:37:52,640 --> 01:37:55,520 SO, APPLICATIONS FOR THE 2291 01:37:55,520 --> 01:37:56,600 RATIONALE SYSTEM 2292 01:37:56,600 --> 01:37:58,760 CHARACTERIZATION SELECT ON 2293 01:37:58,760 --> 01:38:00,120 ADJUVANT FOR RESULTS ARE 2294 01:38:00,120 --> 01:38:01,800 CANDIDATES SHOULD PROPOSE A 2295 01:38:01,800 --> 01:38:04,240 SERIES OF HIV IMMUNOGEN CREATING 2296 01:38:04,240 --> 01:38:07,240 A MATRIX FOR ASSESSMENT OF 2297 01:38:07,240 --> 01:38:07,560 FORMULATIONS. 2298 01:38:07,560 --> 01:38:09,880 AND AS WELL AS BIOCHEMICAL 2299 01:38:09,880 --> 01:38:12,800 IMMUNE LOGICAL BY WHICH THOSE 2300 01:38:12,800 --> 01:38:15,280 FORMULATIONS WILL BE SYSTEM AS 2301 01:38:15,280 --> 01:38:16,480 TICKLY CHER TERRIZED BY IN THE 2302 01:38:16,480 --> 01:38:19,520 SCREEN AND THEY INCLUDE IN VITRO 2303 01:38:19,520 --> 01:38:20,720 SYSTEM AS WELL AS APPROPRIATE 2304 01:38:20,720 --> 01:38:22,760 ANIMAL MODELS AND FINALLY THE 2305 01:38:22,760 --> 01:38:26,080 INVESTIGATION SHOULD GENERATE 2306 01:38:26,080 --> 01:38:29,680 GO/NO-GO CRITERIA BY THE USE OF 2307 01:38:29,680 --> 01:38:31,280 THE METHODS. 2308 01:38:31,280 --> 01:38:33,160 NEXT SLIDE, PLEASE. 2309 01:38:33,160 --> 01:38:35,440 I WANT TO THANK THE REVIEWERS OF 2310 01:38:35,440 --> 01:38:37,200 OUR NEW INITIATIVES AND THE 2311 01:38:37,200 --> 01:38:39,000 HEALTH FOR DISCUSSION THAT 2312 01:38:39,000 --> 01:38:40,200 FOLLOWED DURING OUR MEETING A 2313 01:38:40,200 --> 01:38:41,480 FEW WEEKS AGO. 2314 01:38:41,480 --> 01:38:44,160 REVIEWERS ARE FRANKLY POSITIVE 2315 01:38:44,160 --> 01:38:46,640 AS HIV FUELS AND I QUOTE, 2316 01:38:46,640 --> 01:38:47,920 DESPERATELY NEEDS TO IMPROVE THE 2317 01:38:47,920 --> 01:38:51,120 PROCESS OF ADJUVANT DEVELOPMENT 2318 01:38:51,120 --> 01:38:54,440 AND A DEDICATED MECHANISM FOR 2319 01:38:54,440 --> 01:38:56,000 COMPARING ADJUVANTS RIGOROUSLY 2320 01:38:56,000 --> 01:38:58,120 IN A HEAD-TO-HEAD MANNER MAKES 2321 01:38:58,120 --> 01:38:58,480 SENSE. 2322 01:38:58,480 --> 01:38:59,400 WE RECEIVED SUGGESTIONS AND I 2323 01:38:59,400 --> 01:39:01,160 WANT TO SHARE THOSE. 2324 01:39:01,160 --> 01:39:05,320 FIRST, ABOUT COORDINATING WITH 2325 01:39:05,320 --> 01:39:09,200 DAIT CONTRACTS, MEETINGS, WITH 2326 01:39:09,200 --> 01:39:10,840 OUR INITIATIVE AND WE CONQUER 2327 01:39:10,840 --> 01:39:12,160 WITH THIS IDEA. 2328 01:39:12,160 --> 01:39:14,640 IN FACT, DAIT'S CONTRACTS DO 2329 01:39:14,640 --> 01:39:16,480 HAVE MEETINGS BETWEEN THE GROUPS 2330 01:39:16,480 --> 01:39:17,680 AND WE HAVE HAD INITIAL 2331 01:39:17,680 --> 01:39:20,600 CONVERSATIONS ABOUT INCLUDING 2332 01:39:20,600 --> 01:39:23,120 CONTRACTORS INTO DAIT'S PROGRAMS 2333 01:39:23,120 --> 01:39:24,560 MEETINGS TO HELP CROSS 2334 01:39:24,560 --> 01:39:26,760 POLLINATION AND IN EXCHANGE OF 2335 01:39:26,760 --> 01:39:27,600 IDEAS. 2336 01:39:27,600 --> 01:39:29,560 SECOND, THE SUGGESTION ABOUT 2337 01:39:29,560 --> 01:39:30,760 SPECIFYING THE CHARACTERISTICS 2338 01:39:30,760 --> 01:39:33,280 OF THE IMMUNE RESPONSE DESIRED 2339 01:39:33,280 --> 01:39:36,360 AND SELECT FROM A SET OF 2340 01:39:36,360 --> 01:39:38,600 ADJUVANTS KNOWN TO PROMOTE SUCH 2341 01:39:38,600 --> 01:39:38,880 ACTIVITY. 2342 01:39:38,880 --> 01:39:40,520 WE ALSO CONCUR WITH THIS 2343 01:39:40,520 --> 01:39:43,040 SUGGESTION AND THE CONTRACT CAN 2344 01:39:43,040 --> 01:39:46,000 HAVE LANGUAGE TO REQUIRE THE 2345 01:39:46,000 --> 01:39:47,320 ADJUVANTS PROPOSE THAT 2346 01:39:47,320 --> 01:39:49,600 COMPLIMENT THE IMMUNOGENS AND 2347 01:39:49,600 --> 01:39:50,440 LEAD TO THE DESIRED IMMUNE 2348 01:39:50,440 --> 01:39:50,680 RESPONSE. 2349 01:39:50,680 --> 01:39:52,200 WE BELIEVE IN FACT THAT THE 2350 01:39:52,200 --> 01:39:54,440 INITIAL SELECTION, IN FACT, BE 2351 01:39:54,440 --> 01:39:55,640 GUIDED WITH PREVIOUS EXPERIENCE 2352 01:39:55,640 --> 01:39:57,040 OF OTHER ANTIGENS. 2353 01:39:57,040 --> 01:40:00,960 AND FINALLY, A SUGGEST WILL 2354 01:40:00,960 --> 01:40:02,360 PROVIDING ADDITIONAL SPECIFICITY 2355 01:40:02,360 --> 01:40:05,160 REGARDING WHAT ASPECTS OF THE 2356 01:40:05,160 --> 01:40:08,000 IMMUNO MIGHT BE EVALUATED IN 2357 01:40:08,000 --> 01:40:10,680 COMPARISONS AND WE CONCUR AND 2358 01:40:10,680 --> 01:40:14,440 ALL THE MENU OF METHODOLOGY CAN 2359 01:40:14,440 --> 01:40:16,840 DEPEND ON THE PROPOSE A LOT AND 2360 01:40:16,840 --> 01:40:22,640 WE CAN USE THE HVTN ASSAY 2361 01:40:22,640 --> 01:40:24,080 ALGORITHM TO GUIDE IN THE 2362 01:40:24,080 --> 01:40:27,120 ASSESSMENTS SO IN MY LAST SLIDE, 2363 01:40:27,120 --> 01:40:30,040 PLEASE, SO THIS IS JUST TO 2364 01:40:30,040 --> 01:40:31,680 FINALIZE THIS IS THE MAIN 2365 01:40:31,680 --> 01:40:35,320 OBJECTIVE IS TO FACILITATE THE 2366 01:40:35,320 --> 01:40:38,960 COMBINATIONS AND IS A NEW BROAD 2367 01:40:38,960 --> 01:40:42,160 AGES ANNOUNCEMENT AND FIVE YEARS 2368 01:40:42,160 --> 01:40:44,040 AND THANK YOU SO MUCH AND I LOOK 2369 01:40:44,040 --> 01:40:48,280 FORWARD FOR YOUR QUESTIONS. 2370 01:40:48,280 --> 01:40:52,560 >> THANK YOU, VERY NICE 2371 01:40:52,560 --> 01:40:53,080 PRESENTATION. 2372 01:40:53,080 --> 01:40:54,200 WHILE PEOPLE THINK ABOUT 2373 01:40:54,200 --> 01:40:55,880 QUESTIONS, I WOULD ASK YOU TO 2374 01:40:55,880 --> 01:40:58,280 OPEN, REOPEN YOUR ECBs AND 2375 01:40:58,280 --> 01:41:02,040 VOTE ON THIS CONCEPT AND SEE IF 2376 01:41:02,040 --> 01:41:06,480 WE HAVE ANY QUESTIONS. 2377 01:41:06,480 --> 01:41:06,720 RICH -- 2378 01:41:06,720 --> 01:41:12,440 >> IT SEEMS LIKE A DIFFICULT 2379 01:41:12,440 --> 01:41:13,680 CHESS GAME THAT YOU DON'T REALLY 2380 01:41:13,680 --> 01:41:18,960 KNOW WHERE TO START WITH THE 2381 01:41:18,960 --> 01:41:22,840 ADJUVANT AND MAYBE THE SUM 2382 01:41:22,840 --> 01:41:25,360 ADJUVANTS ARE BETTER FOR 2383 01:41:25,360 --> 01:41:29,040 DIFFERENTIMMUNOGENS? 2384 01:41:29,040 --> 01:41:29,840 >> CORRECT. 2385 01:41:29,840 --> 01:41:32,480 OUR RATIONALE TO PROMOTE THE 2386 01:41:32,480 --> 01:41:34,880 INITIATIVE THAT WAY IS TO CREATE 2387 01:41:34,880 --> 01:41:38,120 THIS MATRIX SO WE CAN INFACT 2388 01:41:38,120 --> 01:41:39,320 SELECT EXACTLY WHAT YOU ARE 2389 01:41:39,320 --> 01:41:41,240 ASKING ABOUT, WHO COMBINES 2390 01:41:41,240 --> 01:41:42,680 BETTER WITH WHO? 2391 01:41:42,680 --> 01:41:47,040 SO, WE STARTED WITH THIS 2392 01:41:47,040 --> 01:41:48,640 WELL-ACCEPTED RATIONALE THAT 2393 01:41:48,640 --> 01:41:54,320 EACH IMMUNOGEN AND ADJUVANT IS A 2394 01:41:54,320 --> 01:41:55,640 UNIQUE MARRIAGE THAT WE EXPAND 2395 01:41:55,640 --> 01:41:57,640 FROM ONE TO THE NEXT AND WE HAVE 2396 01:41:57,640 --> 01:41:59,760 THIS GENERAL IDEA THAT IF YOU 2397 01:41:59,760 --> 01:42:01,640 WORK WITH ONE ANTIGEN WE CAN 2398 01:42:01,640 --> 01:42:05,160 MOVE ON AND PLUG IN WITH THE AIM 2399 01:42:05,160 --> 01:42:06,520 ADJUVANT AND WE NEED TO BE 2400 01:42:06,520 --> 01:42:07,800 PREPARED BEFORE WE MOVE FORWARD 2401 01:42:07,800 --> 01:42:09,680 IN THIS FORMULATIONS TO MAKE 2402 01:42:09,680 --> 01:42:11,360 SURE THAT EACH ONE OF THESE 2403 01:42:11,360 --> 01:42:14,800 MARRIAGE, THIS ANTIGEN, THIS 2404 01:42:14,800 --> 01:42:15,920 ADJUVANT CAN EFFECT WORK AND WE 2405 01:42:15,920 --> 01:42:19,840 ARE PROPOSING THIS PRE CLINICAL 2406 01:42:19,840 --> 01:42:22,800 PLATFORM TO ASSESS THAT. 2407 01:42:22,800 --> 01:42:26,200 >> GREAT. 2408 01:42:26,200 --> 01:42:27,760 >> KEITH, QUESTION? 2409 01:42:27,760 --> 01:42:28,640 YOU ARE ON MUTE. 2410 01:42:28,640 --> 01:42:33,600 >> YEAH, THANK YOU. 2411 01:42:33,600 --> 01:42:35,480 I THINK YOU WERE IN OUR 2412 01:42:35,480 --> 01:42:38,240 CONVERSATION WHEN WE DISCUSSED 2413 01:42:38,240 --> 01:42:41,000 THIS ONE. 2414 01:42:41,000 --> 01:42:44,720 THANK YOU FOR A VERY NICE 2415 01:42:44,720 --> 01:42:45,520 RESPONSIVENESS TO SOME OF OUR 2416 01:42:45,520 --> 01:42:45,800 COMMENTS. 2417 01:42:45,800 --> 01:42:46,680 I REALLY APPRECIATE THAT. 2418 01:42:46,680 --> 01:42:47,960 >> I APPRECIATE YOUR COMMENTS. 2419 01:42:47,960 --> 01:42:50,080 IT WAS REALLY HELPFUL. 2420 01:42:50,080 --> 01:42:52,560 >> I GUESS, WHY I'M STILL A 2421 01:42:52,560 --> 01:42:54,600 LITTLE FUZZY IS SORT OF THE 2422 01:42:54,600 --> 01:42:56,040 CONCEPTS FOR WHAT YOU LOOK AT 2423 01:42:56,040 --> 01:42:59,280 AND WHAT YOU DO, DID THINGS 2424 01:42:59,280 --> 01:43:00,840 ORIGINATE FROM WHOEVER GETS THIS 2425 01:43:00,840 --> 01:43:01,960 BIG CONTRACT? 2426 01:43:01,960 --> 01:43:03,600 O IS THERE MECHANISMS FOR 2427 01:43:03,600 --> 01:43:05,480 OUTSIDE PEOPLE WITH IDEAS TO 2428 01:43:05,480 --> 01:43:06,560 FILTER INTO IT? 2429 01:43:06,560 --> 01:43:09,160 I'M STILL FUZZY ON HOW THIS 2430 01:43:09,160 --> 01:43:12,560 ACTUALLY GETS PROGRAMMED OUT. 2431 01:43:12,560 --> 01:43:16,560 >> THIS IS A BAE SO WE SHOULD 2432 01:43:16,560 --> 01:43:18,920 RECEIVE THE PROPOSAL AND WE GIVE 2433 01:43:18,920 --> 01:43:20,400 THEM LOSE PARAMETERS AND THEY 2434 01:43:20,400 --> 01:43:22,920 TELL US HOW THEY'LL GET THE WORK 2435 01:43:22,920 --> 01:43:26,120 DONE. 2436 01:43:26,120 --> 01:43:28,200 NOW, THEY HAVE SOME FLEXIBILITY 2437 01:43:28,200 --> 01:43:30,760 IN DECIDING ABOUT WHAT TO 2438 01:43:30,760 --> 01:43:31,400 ACCEPT. 2439 01:43:31,400 --> 01:43:33,360 WE CAN ACCEPT PART OF THE 2440 01:43:33,360 --> 01:43:35,440 PROPOSAL AND WE CAN EVEN PRE 2441 01:43:35,440 --> 01:43:38,640 POSE SPECIFIC COMBINATIONS OF 2442 01:43:38,640 --> 01:43:39,800 ADJUVANTS WE WANT TO BE PART OF 2443 01:43:39,800 --> 01:43:42,280 THAT COMPARISON SO THE BA 2444 01:43:42,280 --> 01:43:44,880 MECHANISM GIVES US FLEXIBILITY, 2445 01:43:44,880 --> 01:43:47,200 NOT ONLY TO ACCEPT PARTIAL, PART 2446 01:43:47,200 --> 01:43:51,040 OF THE PROPOSALS BUT ALSO TO 2447 01:43:51,040 --> 01:43:53,240 INCLUDE IF WE, AT THE TIME, WE 2448 01:43:53,240 --> 01:43:55,160 HAVE SOME COMPARE TO BEES AND 2449 01:43:55,160 --> 01:43:59,400 SOME AD ADJUVANT COMING FROM 2450 01:43:59,400 --> 01:44:01,080 CLINICAL TRIALS AND NON HUMAN 2451 01:44:01,080 --> 01:44:02,600 PRIMATES AND EXPERIMENTS THAT WE 2452 01:44:02,600 --> 01:44:04,600 THINK ARE RELEVANT AND WE WOULD 2453 01:44:04,600 --> 01:44:06,520 LIKE TO SEE BEING PERFORMED IN 2454 01:44:06,520 --> 01:44:08,840 THAT SPECIFIC PLATFORM. 2455 01:44:08,840 --> 01:44:14,280 DOES THAT ANSWER YOUR QUESTION? 2456 01:44:14,280 --> 01:44:20,520 THANK YOU. 2457 01:44:20,520 --> 01:44:23,000 >> THANK YOU, VERY MUCH. 2458 01:44:23,000 --> 01:44:25,040 >> THANK YOU SO MUCH. 2459 01:44:25,040 --> 01:44:28,960 >> OUR NEXT CONCEPT IS ENTITLED 2460 01:44:28,960 --> 01:44:31,360 INNOVATION FOR HIV VACCINES 2461 01:44:31,360 --> 01:44:33,840 DISCOVERY IHBD WILL BE PRESENTED 2462 01:44:33,840 --> 01:44:38,360 BY Dr. JOHN WARREN. 2463 01:44:38,360 --> 01:44:40,160 >> THANK YOU. 2464 01:44:40,160 --> 01:44:41,440 HELLO, EVERYONE. 2465 01:44:41,440 --> 01:44:44,160 CAN YOU HEAR ME OK? 2466 01:44:44,160 --> 01:44:44,920 >> YES. 2467 01:44:44,920 --> 01:44:46,600 >> THANK YOU, KEN. 2468 01:44:46,600 --> 01:44:48,880 IT'S IN DEED MY PRIVILEGE TO 2469 01:44:48,880 --> 01:44:50,400 REPRESENT THE VACCINE RESEARCH 2470 01:44:50,400 --> 01:44:53,320 PROGRAM AND ASKING FOR YOUR 2471 01:44:53,320 --> 01:44:53,680 APPROVAL. 2472 01:44:53,680 --> 01:44:56,680 FOR US TO RENEW AND REISSUE THE 2473 01:44:56,680 --> 01:44:58,800 INNOVATION FOR HIV VACCINE 2474 01:44:58,800 --> 01:45:00,000 DISCOVERY INITIATIVE. 2475 01:45:00,000 --> 01:45:07,360 AS MY NOW-RETIRED AND H ESTEEM L 2476 01:45:07,360 --> 01:45:09,600 EQUAL ALAN SHULTZ IT'S LIKELY TO 2477 01:45:09,600 --> 01:45:11,360 REDIVINE VIRAL HOST IMMUNOLOGY 2478 01:45:11,360 --> 01:45:13,000 AS WE CURRENTLY UNDERSTAND IT, 2479 01:45:13,000 --> 01:45:14,440 GIVEN AFTER MORE THAN 30 YEARS 2480 01:45:14,440 --> 01:45:16,240 OF BASIC AND CLINICAL VACCINE 2481 01:45:16,240 --> 01:45:17,200 RESEARCH AND EFFECTIVE VACCINE 2482 01:45:17,200 --> 01:45:24,160 HAS NOT BEEN ACHIEVED. 2483 01:45:24,160 --> 01:45:27,160 SO, THUS, THE OBJECTIVE IN THIS 2484 01:45:27,160 --> 01:45:30,360 RENEWAL IS TO STIMULATE NOVEL 2485 01:45:30,360 --> 01:45:31,760 HIGH-RISK, EYE IMPACT EARLY 2486 01:45:31,760 --> 01:45:33,720 DISCOVERY RESEARCH THAT MAY HAVE 2487 01:45:33,720 --> 01:45:35,800 SIGNIFICANT IMPACT ON THE DESIGN 2488 01:45:35,800 --> 01:45:37,120 DEVELOPMENT OF SUCCESSFUL 2489 01:45:37,120 --> 01:45:39,560 STRATEGIES FOR EFFECTIVE 2490 01:45:39,560 --> 01:45:40,800 VACCINES. 2491 01:45:40,800 --> 01:45:44,160 IT WILL USE MILESTONE DRIVEN 2492 01:45:44,160 --> 01:45:45,960 APPROACHES AND TO FUND 2493 01:45:45,960 --> 01:45:47,360 HIGH-RISK' SEARCH WHICH IS 2494 01:45:47,360 --> 01:45:48,200 SIGNIFICANTLY DIFFERENT FROM 2495 01:45:48,200 --> 01:45:50,440 MOST RO1 PROJECTS. 2496 01:45:50,440 --> 01:45:56,240 THE MECHANISM IS THREE-YEAR PAR 2497 01:45:56,240 --> 01:45:58,120 PROGRAM ANNOUNCEMENT. 2498 01:45:58,120 --> 01:46:00,480 WE SEE PROGRAM SET ASIDE FUNDING 2499 01:46:00,480 --> 01:46:02,960 OF $2 MILLION FOR FISCAL YEAR 2500 01:46:02,960 --> 01:46:03,720 2024. 2501 01:46:03,720 --> 01:46:05,640 FUNDING CAN BE ACHIEVED EITHER 2502 01:46:05,640 --> 01:46:07,880 WITH THIS SET-ASIDE SUPPORT OR 2503 01:46:07,880 --> 01:46:09,680 MEETING THE RO1 PAYLINE. 2504 01:46:09,680 --> 01:46:12,000 THIS INITIATIVE HAS BEEN THE 2505 01:46:12,000 --> 01:46:14,400 PRINCIPLE ENTRY LEVEL SOLICITED 2506 01:46:14,400 --> 01:46:16,600 PROGRAM WITHIN VRP THAT SUPPORTS 2507 01:46:16,600 --> 01:46:18,800 ENTIRELY NEW UNTESTED AIDS 2508 01:46:18,800 --> 01:46:20,560 VACCINE RESEARCH IDEAS. 2509 01:46:20,560 --> 01:46:22,640 AND AS IN PRIOR ITERATIONS IT 2510 01:46:22,640 --> 01:46:24,960 WILL ALSO SEEK TO PROMOTE AND 2511 01:46:24,960 --> 01:46:26,880 ADVANCE CAREER DEVELOPMENT BY 2512 01:46:26,880 --> 01:46:28,280 ATTRACTING NEW INVESTIGATORS, 2513 01:46:28,280 --> 01:46:30,880 EARLY STAGE PIs AND HOPEFULLY 2514 01:46:30,880 --> 01:46:34,400 AT-RISK PIs WITH THEIR NEW 2515 01:46:34,400 --> 01:46:35,000 IDEAS. 2516 01:46:35,000 --> 01:46:37,520 SO, IT'S IMPORTANT THEN TO 2517 01:46:37,520 --> 01:46:39,120 REALIZE THAT THERE REMAINS A 2518 01:46:39,120 --> 01:46:41,360 VITAL NEED TO CULTIVATE NEW 2519 01:46:41,360 --> 01:46:42,560 PARADIGMS THROUGH DISCOVERY 2520 01:46:42,560 --> 01:46:46,920 RESEARCH AND UNTIL AN HIV 2521 01:46:46,920 --> 01:46:48,640 VACCINE IS DURABLE THERE'S A AT 2522 01:46:48,640 --> 01:46:49,400 ANY TIME NEED FOR EARLY 2523 01:46:49,400 --> 01:46:52,000 DISCOVERY AND TRULY INNOVATIVE 2524 01:46:52,000 --> 01:46:53,560 RESEARCH AND TO FULLY LEVERAGE 2525 01:46:53,560 --> 01:46:55,320 THE ACCELERATED SIGNIFICANCE OF 2526 01:46:55,320 --> 01:46:57,000 VACCINE RESEARCH CATALYZED BY 2527 01:46:57,000 --> 01:47:03,240 THE COVID PANDEMIC. 2528 01:47:03,240 --> 01:47:05,640 THERE'S ONE NOTABLE CHANGE FROM 2529 01:47:05,640 --> 01:47:07,000 PRIOR INITIATIVES. 2530 01:47:07,000 --> 01:47:09,480 IN THAT THE PRIMARY FOCUS OF 2531 01:47:09,480 --> 01:47:12,600 THIS INITIATIVE, IT WILL BE IN 2532 01:47:12,600 --> 01:47:14,240 THIS ROW NEWELL, IT WILL BE TO 2533 01:47:14,240 --> 01:47:16,360 SUPPORT NOVEL EXPLORATORY 2534 01:47:16,360 --> 01:47:17,480 RESEARCH TOWARDS A SUCCESSFUL 2535 01:47:17,480 --> 01:47:19,160 VACCINE STRATEGY WITH KNOWS 2536 01:47:19,160 --> 01:47:20,600 PRECEDENCE IN LITERATURE AND 2537 01:47:20,600 --> 01:47:22,160 THOSE SECONDARILY IT WILL 2538 01:47:22,160 --> 01:47:24,640 CONTINUE TO CONSIDER SUPPORT FOR 2539 01:47:24,640 --> 01:47:28,320 WORTHY, NOVEL BASIC VACCINE 2540 01:47:28,320 --> 01:47:29,480 DISCOVERY RESEARCH THAT'S NOT 2541 01:47:29,480 --> 01:47:35,960 FULLY BEEN EXPLOITED. 2542 01:47:35,960 --> 01:47:39,360 SO, IN OUR PRIOR AND ACTIVE, WE 2543 01:47:39,360 --> 01:47:41,920 PLAN TO MANAGE THE ASSOCIATED 2544 01:47:41,920 --> 01:47:44,560 HIGH-RISK USING TWO STRATEGIES. 2545 01:47:44,560 --> 01:47:47,120 THE FIRST, IS THAT -- AND NEXT, 2546 01:47:47,120 --> 01:47:47,560 PLEASE. 2547 01:47:47,560 --> 01:47:53,080 THE FIRST IS THAT BECAUSE RO1 2548 01:47:53,080 --> 01:47:55,840 CAN BE COMPETITIVE IN THE RESKE 2549 01:47:55,840 --> 01:47:57,800 PEER REVIEW LIMITED OR ABSENCE 2550 01:47:57,800 --> 01:48:00,760 OF PRELIMINARY DATA IN THE 2551 01:48:00,760 --> 01:48:01,960 APPLICATIONS SHOULD NOT 2552 01:48:01,960 --> 01:48:03,440 NEGATIVELY IMPACT THE SCORE. 2553 01:48:03,440 --> 01:48:04,480 THIS IS SIGNIFICANTLY DIFFERENT 2554 01:48:04,480 --> 01:48:07,840 FROM MOST RO1 PROJECTS. 2555 01:48:07,840 --> 01:48:11,000 THE SECOND STRATEGY IS INCLUSION 2556 01:48:11,000 --> 01:48:14,080 OF GO/NO GO MILESTONES WITH 2557 01:48:14,080 --> 01:48:16,120 CLEAR METRICS TO BE A CHEERED BY 2558 01:48:16,120 --> 01:48:18,320 THE YEAR 2 PROGRESS REPORT AND 2559 01:48:18,320 --> 01:48:19,640 THESE WILL BE EVALUATED BY 2560 01:48:19,640 --> 01:48:20,960 PROGRAM BEFORE ADDITIONAL 2561 01:48:20,960 --> 01:48:22,200 FUNDING PROVIDED. 2562 01:48:22,200 --> 01:48:26,040 THIS IS A LANGUAGE STANDING USE 2563 01:48:26,040 --> 01:48:30,160 OF GO/NO-GO AND IT IS BACK IN 2564 01:48:30,160 --> 01:48:35,840 THE PROGRAM IN 2006 OR 2007. 2565 01:48:35,840 --> 01:48:37,400 AND BEFORE I GET TO THE 2566 01:48:37,400 --> 01:48:38,600 RESPONSIVE RESEARCH AREAS, I 2567 01:48:38,600 --> 01:48:40,680 WANT TO SAY THAT WE'VE BEEN 2568 01:48:40,680 --> 01:48:42,520 INSTRUCTED THAT THERE ARE NEW 2569 01:48:42,520 --> 01:48:45,840 REVIEW CRITERIA AND THERE ARE 2570 01:48:45,840 --> 01:48:48,360 THREE OF THEM NOW NOT FIVE AND 2571 01:48:48,360 --> 01:48:50,280 IT'S IMPORTANCE IS ONE, 2572 01:48:50,280 --> 01:48:56,160 FEASIBILITY AND RIGOR AS TWO AND 2573 01:48:56,160 --> 01:48:56,400 EXPERTISE. 2574 01:48:56,400 --> 01:48:57,880 I WANT TO MENTION THESE 2575 01:48:57,880 --> 01:48:59,320 APPLICATIONS COME IN PROPOSING 2576 01:48:59,320 --> 01:49:01,360 THEIR WORK FOR THE FULL FOUR 2577 01:49:01,360 --> 01:49:03,600 YEARS AND IF SOME DO NOT 2578 01:49:03,600 --> 01:49:04,760 TRANSITION INTO YEARS THREE AND 2579 01:49:04,760 --> 01:49:06,200 FOUR WITH FULL FUNDING THESE 2580 01:49:06,200 --> 01:49:09,400 INSTEAD MAY HAVE THE OPTION TO 2581 01:49:09,400 --> 01:49:10,680 OBTAIN NEGOTIATED SHUT DOWN 2582 01:49:10,680 --> 01:49:12,240 DOLLARS IN YEAR THREE WITH NO 2583 01:49:12,240 --> 01:49:13,760 FUNDS IN YEAR FOUR AND ANY 2584 01:49:13,760 --> 01:49:15,240 RESULTING SAVINGS WE GO BACK TO 2585 01:49:15,240 --> 01:49:16,920 PROGRAM TO SUPPORT THE NEW 2586 01:49:16,920 --> 01:49:18,480 GRANTS IN THE SECOND OR THIRD 2587 01:49:18,480 --> 01:49:19,280 YEAR. 2588 01:49:19,280 --> 01:49:21,720 APPLICATIONS CYCLE OF THE 2589 01:49:21,720 --> 01:49:22,920 THREE-YEAR PAR OR IT COULD BE 2590 01:49:22,920 --> 01:49:25,880 USED FOR GRANT SUPPLEMENTS. 2591 01:49:25,880 --> 01:49:29,280 THIS SLIDE ACTUALLY SAYS THAT 2592 01:49:29,280 --> 01:49:31,160 THE RESPONSIVE AREAS OF RESEARCH 2593 01:49:31,160 --> 01:49:33,080 AND I'LL JUST GO THROUGH THEM 2594 01:49:33,080 --> 01:49:33,640 QUICKLY. 2595 01:49:33,640 --> 01:49:36,280 THE FIRST ONE HERE IS NOVEL 2596 01:49:36,280 --> 01:49:38,440 VACCINE APPROACHES TO ILLICIT 2597 01:49:38,440 --> 01:49:40,560 DURABLE CELLULAR RESPONSES AND 2598 01:49:40,560 --> 01:49:42,280 HUMORAL PROTECTIVE IMMUNITY AND 2599 01:49:42,280 --> 01:49:44,560 I WANT TO ADD IN ADDITION WE ARE 2600 01:49:44,560 --> 01:49:46,480 INTERESTED IN GENERATING BREADTH 2601 01:49:46,480 --> 01:49:50,360 OF THESE RESPONSES SO THE TWO 2602 01:49:50,360 --> 01:49:52,880 HUGE DELEM AS ARE STILL IN THIS 2603 01:49:52,880 --> 01:49:53,080 FIELD. 2604 01:49:53,080 --> 01:49:55,000 AND WE ALSO WANT TO TARGET 2605 01:49:55,000 --> 01:49:57,120 INNATE INDUCED OR IMPRINTED 2606 01:49:57,120 --> 01:49:58,680 INNATE IMMUNE RESPONSES THAT CAN 2607 01:49:58,680 --> 01:50:02,520 BE RECALLED IN RESPONSE TO 2608 01:50:02,520 --> 01:50:03,960 SUBSEQUENT VACCINATIONS. 2609 01:50:03,960 --> 01:50:07,280 AND NOVEL STRATEGIES FOR BOTH OF 2610 01:50:07,280 --> 01:50:09,160 THESE KINDS OF RESPONSES AND 2611 01:50:09,160 --> 01:50:12,120 THEY'RE RELEVANT TO CERTAIN AN 2612 01:50:12,120 --> 01:50:15,320 TOM I CANAL SITES SO MUCOSAL 2613 01:50:15,320 --> 01:50:25,680 SITES SPECIFICALLY. 2614 01:50:32,720 --> 01:50:35,840 AND NEW MALL MODELS BUT THESE 2615 01:50:35,840 --> 01:50:36,960 HAVE TO BE SPECIFICALLY LINKED 2616 01:50:36,960 --> 01:50:39,520 TO A NOVEL VACCINE INTERVENTION 2617 01:50:39,520 --> 01:50:41,480 STRATEGY FOR PREVENTION OF 2618 01:50:41,480 --> 01:50:43,360 ACQUISITION OR CLEARANCE OF 2619 01:50:43,360 --> 01:50:46,600 VIRUS OR INFECTED CELLS. 2620 01:50:46,600 --> 01:50:49,440 SO, CONTINUING THE RESPONSIVE 2621 01:50:49,440 --> 01:50:50,960 AREAS, HE ENCOURAGE THE USE OF 2622 01:50:50,960 --> 01:50:52,800 CLINICAL SPECIMENS, FOR EXAMPLE, 2623 01:50:52,800 --> 01:50:57,640 FROM THE HVTN STUDIES TO ANSWER 2624 01:50:57,640 --> 01:50:59,480 QUESTION QUESTIONS ABOUT THE 2625 01:50:59,480 --> 01:51:01,400 IMMUNE RESPONSES. 2626 01:51:01,400 --> 01:51:05,880 AND WE'RE ALWAYS INTERESTED IN 2627 01:51:05,880 --> 01:51:08,240 EXPLORING DIFFERENT OR NEW 2628 01:51:08,240 --> 01:51:13,000 ENCODED TARGETS AS AND WE WANT 2629 01:51:13,000 --> 01:51:14,960 TO PROMOTE ARTIFICIAL 2630 01:51:14,960 --> 01:51:15,520 INTELLIGENCE AND MACHINE 2631 01:51:15,520 --> 01:51:17,760 LEARNING APPROACHES ARE 2632 01:51:17,760 --> 01:51:20,840 ENCOURAGED IN THIS. 2633 01:51:20,840 --> 01:51:21,920 SO NONRESPONSE I HAVE RESEARCH, 2634 01:51:21,920 --> 01:51:23,600 BASIC ONCE ARE, WE'RE NOT GOING 2635 01:51:23,600 --> 01:51:24,640 TO SUPPORT PRODUCT DEVELOPMENT 2636 01:51:24,640 --> 01:51:28,080 OR HUMAN CLINICAL TRIALS. 2637 01:51:28,080 --> 01:51:31,120 AND WE'RE NOT GOING TO SUPPORT 2638 01:51:31,120 --> 01:51:33,120 SCRIPT TIVE RESEARCH OR 2639 01:51:33,120 --> 01:51:35,680 STRUCTURAL STUDIES WITHOUT A 2640 01:51:35,680 --> 01:51:38,200 DIRECT APPLICATION TO HIV 2641 01:51:38,200 --> 01:51:38,920 VACCINES. 2642 01:51:38,920 --> 01:51:43,920 AND FAILURE OBVIOUSLY TO PROVIDE 2643 01:51:43,920 --> 01:51:47,440 DETAILS GOING GO/NO-GO MILESTONE 2644 01:51:47,440 --> 01:51:47,800 CRITERIA. 2645 01:51:47,800 --> 01:51:50,560 SO THE HISTORY HERE HAS JUST 2646 01:51:50,560 --> 01:51:54,400 BRIEFLY HAVE BEEN SIX PREVIOUSLY 2647 01:51:54,400 --> 01:51:56,680 IHVD SINCE 2012, THAT'S OF THE 2648 01:51:56,680 --> 01:51:57,880 LAST 10 YEARS WITH SIMILAR 2649 01:51:57,880 --> 01:51:59,200 OBJECTIVES AND 30 APPLICATIONS 2650 01:51:59,200 --> 01:52:00,840 WERE FUNDED IN THIS PERIOD AND 2651 01:52:00,840 --> 01:52:05,880 THE PRIOR THREE-YEAR PAR FOR 2652 01:52:05,880 --> 01:52:08,000 FISCAL YEAR '18 THROUGH '20 AND 2653 01:52:08,000 --> 01:52:10,000 IT FUNDED THREE APPLICATIONS 2654 01:52:10,000 --> 01:52:11,920 WITH SET ASIDE DOLLARS. 2655 01:52:11,920 --> 01:52:14,560 AND CURRENTLY ACTIVE PAR FOR 2656 01:52:14,560 --> 01:52:17,760 FISCAL YEARS 21-23 HAD ONE AWARD 2657 01:52:17,760 --> 01:52:20,840 FOR FISCAL '21 AND NONE WHY 2658 01:52:20,840 --> 01:52:23,080 FUNDED IN '22 AND WE HAD NO SET 2659 01:52:23,080 --> 01:52:25,000 ASIDE FUNDS AND NONE OF THOSE 2660 01:52:25,000 --> 01:52:27,640 MADE PAYLINE AND WE HAD A ROBUST 2661 01:52:27,640 --> 01:52:32,160 SET OF APPLICATIONS, FOR FISCAL 2662 01:52:32,160 --> 01:52:35,040 '23, THE CURRENT PAR IS STILL 2663 01:52:35,040 --> 01:52:37,520 ACTIVE AND THE RECEIPT DATE WAS 2664 01:52:37,520 --> 01:52:39,160 JULY AND END OF JULY THIS YEAR 2665 01:52:39,160 --> 01:52:41,920 AND WE RECEIVED A VERY ROBUST 2666 01:52:41,920 --> 01:52:43,680 SET OF APPLICATIONS AND THESE GO 2667 01:52:43,680 --> 01:52:46,280 TO REVIEW IN NOVEMBER. 2668 01:52:46,280 --> 01:52:48,560 FROM THE PREVIOUS 30 AWARDS, SIX 2669 01:52:48,560 --> 01:52:50,560 PROJECTS HAVE ADVANCED PASS 2670 01:52:50,560 --> 01:52:53,040 INNOVATION GRANT STATES TO 2671 01:52:53,040 --> 01:52:55,440 RECEIVE CONTINUING FUNDING VERY 2672 01:52:55,440 --> 01:52:58,880 RO1s OR OTHER PROJECTS WITHIN 2673 01:52:58,880 --> 01:53:02,560 PO1s OR ADVANCE AWARDS AND I 2674 01:53:02,560 --> 01:53:04,640 THINK ANGELA CHOSE SOME OF THESE 2675 01:53:04,640 --> 01:53:06,280 AND I'LL JUST -- SO BEFORE 2676 01:53:06,280 --> 01:53:09,000 CLOSING, I WANT TO NOTE TWO 2677 01:53:09,000 --> 01:53:12,080 PRIOR IE3D AWARDS AND THESE WERE 2678 01:53:12,080 --> 01:53:17,000 BOTH AWARDED IN FISCAL YEAR 2016 2679 01:53:17,000 --> 01:53:19,120 AND NEXT, AND THE FIRST ONE I'LL 2680 01:53:19,120 --> 01:53:21,280 DESCRIBE IS, THAT TO DREW WISE 2681 01:53:21,280 --> 01:53:22,720 MAN AT THE UNIVERSITY OF 2682 01:53:22,720 --> 01:53:25,560 PENNSYLVANIA WITH HIS MRNA 2683 01:53:25,560 --> 01:53:27,440 BANANA PARTICLE PLATFORMS AND 2684 01:53:27,440 --> 01:53:36,200 THIS OF COURSE, WAS, THIS IS HIS 2685 01:53:36,200 --> 01:53:38,040 PIONEERED FOUNDATIONAL RNA 2686 01:53:38,040 --> 01:53:38,960 MODIFICATION TECHNOLOGY THAT 2687 01:53:38,960 --> 01:53:42,280 PLAYED A CRITICAL ROLE IN BOTH 2688 01:53:42,280 --> 01:53:44,680 OF PFIZER BION TECH FOR COVID 2689 01:53:44,680 --> 01:53:48,080 AND THE SECOND ONE IS FROM LOUIS 2690 01:53:48,080 --> 01:53:51,080 PICKER AND THE VACCINES AND THIS 2691 01:53:51,080 --> 01:53:55,360 IS A VERY EXCITE TECHNOLOGY IS 2692 01:53:55,360 --> 01:53:59,200 ALSO BEING FOLLOWED UP IN MORE 2693 01:53:59,200 --> 01:54:02,720 ADVANCED PROGRAMS SUPPORTED 2694 01:54:02,720 --> 01:54:05,520 RESEARCH AND WE LOOK FORWARD TO 2695 01:54:05,520 --> 01:54:07,640 DEVELOPING THAT FURTHER. 2696 01:54:07,640 --> 01:54:09,640 NEXT, FINALLY. 2697 01:54:09,640 --> 01:54:10,840 NEXT, PLEASE. 2698 01:54:10,840 --> 01:54:16,240 SO, JUST A REPEAT OF THE INITIAL 2699 01:54:16,240 --> 01:54:17,880 SLIDE DESCRIBING ABOUT WHAT WE 2700 01:54:17,880 --> 01:54:20,240 WANT TO DO. 2701 01:54:20,240 --> 01:54:23,320 FINALLY, THE COMMENTS FROM THE 2702 01:54:23,320 --> 01:54:26,320 REVIEWERS. 2703 01:54:26,320 --> 01:54:27,240 NEXT SLIDE. 2704 01:54:27,240 --> 01:54:37,000 NEXT SLIDE, PLEASE. 2705 01:54:37,000 --> 01:54:38,720 >> BOTH WERE STRONGLY IN SUPPORT 2706 01:54:38,720 --> 01:54:39,960 AND HIGHLY RECOMMENDED APPROVAL 2707 01:54:39,960 --> 01:54:45,200 TO RENEW THIS CONCEPT AND AND 2708 01:54:45,200 --> 01:54:50,200 NEVER TESTED FOR THE NEXT. 2709 01:54:50,200 --> 01:55:00,760 AND GOT NO GO APPROACH MANAGING 2710 01:55:01,040 --> 01:55:03,120 THEY MIGHT NOT HAVE ACCESS AND 2711 01:55:03,120 --> 01:55:04,760 ONE HAS BEEN PROPOSED AND FUNDED 2712 01:55:04,760 --> 01:55:15,320 BEFORE REVIEWERS SUGGEST AND FOR 2713 01:55:17,440 --> 01:55:18,640 ADVICE CONCERNING THE NOVELTY OF 2714 01:55:18,640 --> 01:55:20,400 THE PROPOSED RESEARCH AND I'M 2715 01:55:20,400 --> 01:55:21,880 HAPPY TO TAKE YOUR QUESTIONS, 2716 01:55:21,880 --> 01:55:22,680 THANK YOU, VERY MUCH. 2717 01:55:22,680 --> 01:55:23,520 >> GREAT. 2718 01:55:23,520 --> 01:55:26,000 THANK YOU. 2719 01:55:26,000 --> 01:55:26,560 Dr. WARREN. 2720 01:55:26,560 --> 01:55:31,080 FOR A VERY NICE PRESENTATION. 2721 01:55:31,080 --> 01:55:31,520 QUESTIONS? 2722 01:55:31,520 --> 01:55:33,320 LET ME ASK PEOPLE AND REMIND 2723 01:55:33,320 --> 01:55:38,360 PEOPLE TO OPEN THEIR ECBs AND 2724 01:55:38,360 --> 01:55:38,840 VOTE. 2725 01:55:38,840 --> 01:55:39,160 YES, PAUL. 2726 01:55:39,160 --> 01:55:42,160 >> JOHN, HOW DID YOU COME UP 2727 01:55:42,160 --> 01:55:44,000 WITH THE YEARS TO FUND? 2728 01:55:44,000 --> 01:55:45,600 IS IT WHAT IS AVAILABLE OR IT'S 2729 01:55:45,600 --> 01:55:46,680 BEEN SUCCESSFUL IN THE PAST? 2730 01:55:46,680 --> 01:55:48,760 I MEAN I CAN IMAGINE IF YOU COME 2731 01:55:48,760 --> 01:55:54,880 UP WITH SOMETHING AND NOVEL AND 2732 01:55:54,880 --> 01:55:56,560 MAY TAKE MORE TIME TO DEVELOP. 2733 01:55:56,560 --> 01:55:57,960 >> YEARS TO FUND? 2734 01:55:57,960 --> 01:56:00,760 SO, CAN YOU BE A LITTLE MORE 2735 01:56:00,760 --> 01:56:01,280 SPECIFIC? 2736 01:56:01,280 --> 01:56:02,440 >> YOU MEAN -- 2737 01:56:02,440 --> 01:56:04,520 >> YOU MEAN JUST WITHIN THE 2738 01:56:04,520 --> 01:56:05,640 FOUR-YEAR GRANT. 2739 01:56:05,640 --> 01:56:07,040 >> YEAH, THAT'S WHAT I MEAN. 2740 01:56:07,040 --> 01:56:13,840 >> SO, CURRENTLY, WHAT WE DO IS 2741 01:56:13,840 --> 01:56:17,240 IT GOES TO PEER REVIEW AND IT 2742 01:56:17,240 --> 01:56:20,200 GETS SCORED AND ADDS A TYPICAL 2743 01:56:20,200 --> 01:56:23,000 RO1 FUNDED THROUGH PAYLINE, FOR 2744 01:56:23,000 --> 01:56:23,480 EXAMPLE. 2745 01:56:23,480 --> 01:56:24,600 AND I SHOULD HAVE MENTIONED BY 2746 01:56:24,600 --> 01:56:27,760 THE WAY IF NON HUMAN PRIMATES OR 2747 01:56:27,760 --> 01:56:30,480 HUMANIZED MOUSE MODELS ARE USED 2748 01:56:30,480 --> 01:56:33,560 THE INVESTIGATORS WILL HAVE UP 2749 01:56:33,560 --> 01:56:35,560 TO 150,000 OR THERE ABOUTS FOR A 2750 01:56:35,560 --> 01:56:37,920 YEAR TO SUPPORT THOSE ACTIVITIES 2751 01:56:37,920 --> 01:56:41,960 AND THIS GRANT MECHANISM SO, AT 2752 01:56:41,960 --> 01:56:43,880 ONE POINT IN TIME, THIS GRANT 2753 01:56:43,880 --> 01:56:45,960 MECHANISM WAS AN R21 AND R33 2754 01:56:45,960 --> 01:56:48,040 WHICH WAS FIVE-YEARS TO SUPPORT 2755 01:56:48,040 --> 01:56:53,640 OF R33 POST TRANSITION AND IT 2756 01:56:53,640 --> 01:56:55,000 BECAME FIVE YEARS WITH NO 2757 01:56:55,000 --> 01:56:56,760 TRANSITION AND THEN WE WENT BACK 2758 01:56:56,760 --> 01:57:01,120 TO THE RO1 THIS TIME WITH FOUR 2759 01:57:01,120 --> 01:57:02,760 YEARS AND THE AMOUNTS OF MONEY 2760 01:57:02,760 --> 01:57:05,280 THAT WERE USED TO FUND EACH OF 2761 01:57:05,280 --> 01:57:10,920 THOSE DIV DIFFERENT ITERATIONS Y 2762 01:57:10,920 --> 01:57:13,360 BUT IT WAS CONSISTENT OVER TIME. 2763 01:57:13,360 --> 01:57:14,880 I DON'T THINK, I MEAN WE'RE 2764 01:57:14,880 --> 01:57:16,200 ASKING FOR $2 MILLION FOR THE 2765 01:57:16,200 --> 01:57:19,840 FIRST YEAR OF THIS NEW 2766 01:57:19,840 --> 01:57:22,160 THREE-YEAR PAR, BEGINNING FISCAL 2767 01:57:22,160 --> 01:57:23,600 YEAR 24°, IT CERTAINLY WOULD BE 2768 01:57:23,600 --> 01:57:26,040 NICE TO ASK FOR MORE IF THOSE 2769 01:57:26,040 --> 01:57:27,240 ARE AVAILABLE. 2770 01:57:27,240 --> 01:57:30,240 AND SOMETIMES WE CAN GET -- WE 2771 01:57:30,240 --> 01:57:31,800 CAN SUPPLEMENT THESE GRANTS, 2772 01:57:31,800 --> 01:57:33,240 TYPICAL RO1s AS WELL. 2773 01:57:33,240 --> 01:57:36,600 I DON'T KNOW IF THAT ANSWERED 2774 01:57:36,600 --> 01:57:37,200 YOUR QUESTION. 2775 01:57:37,200 --> 01:57:39,640 >> YEAH, THANK YOU. 2776 01:57:39,640 --> 01:57:41,880 >> Dr. JEROME. 2777 01:57:41,880 --> 01:57:42,400 >> YEAH. 2778 01:57:42,400 --> 01:57:44,520 JOHN, THAT'S REALLY NICE AND I 2779 01:57:44,520 --> 01:57:47,120 ALWAYS LOVE THE EMPHASIS ON 2780 01:57:47,120 --> 01:57:47,520 INNOVATION. 2781 01:57:47,520 --> 01:57:48,680 YOU STARTED TO ADDRESS THIS 2782 01:57:48,680 --> 01:57:50,120 RIGHT AT THE END. 2783 01:57:50,120 --> 01:57:51,520 IT STRIKES ME THAT PART OF THIS 2784 01:57:51,520 --> 01:57:53,600 STARTS TO INTERSECT A LITTLE BIT 2785 01:57:53,600 --> 01:57:57,640 WITH THE SNAP--WE HEARD ABOUT 2786 01:57:57,640 --> 01:57:59,920 WITH THE mRNA PLATFORMS AND 2787 01:57:59,920 --> 01:58:03,800 YOU CAN HANDLE THAT -- IS 2788 01:58:03,800 --> 01:58:04,440 SOMETHING OWN HAVE A TIVE OR NOT 2789 01:58:04,440 --> 01:58:07,320 IN THESE CONVERSATIONS THAT YOU 2790 01:58:07,320 --> 01:58:08,120 WANT TO HAVE? 2791 01:58:08,120 --> 01:58:09,760 IS THERE A CROSS-REFERENCE, I 2792 01:58:09,760 --> 01:58:11,880 DON'T KNOW IF YOU DO THIS, I 2793 01:58:11,880 --> 01:58:15,800 MEAN, SOMEONE LOOKS AT THIS AND 2794 01:58:15,800 --> 01:58:19,280 IF FOR MORE PRODUCTS OR 2795 01:58:19,280 --> 01:58:20,440 APPROACHES FARTHER ALONG THE 2796 01:58:20,440 --> 01:58:21,840 DEVELOPMENT OF THE PATHWAY MIGHT 2797 01:58:21,840 --> 01:58:22,720 CONSIDER THIS PROGRAM 2798 01:58:22,720 --> 01:58:26,520 ANNOUNCEMENT OR THIS CONCEPT AS 2799 01:58:26,520 --> 01:58:32,920 WELL? 2800 01:58:32,920 --> 01:58:37,040 >> THOUGHT I SHOULD ADDRESS THAT 2801 01:58:37,040 --> 01:58:38,800 QUESTION AND I THOUGHT I SHOULD 2802 01:58:38,800 --> 01:58:43,920 WRITE SOMETHING DOWN SO IN A 2803 01:58:43,920 --> 01:58:46,640 SENSE SNAP-H IS IN PART OF 2804 01:58:46,640 --> 01:58:50,960 COURSE HIGHLY IMPORTANT 2805 01:58:50,960 --> 01:58:53,160 DEVELOPMENTAL PHASE OF THE 2806 01:58:53,160 --> 01:58:56,480 WISEMAN PLATFORM FOR mRNA LIP 2807 01:58:56,480 --> 01:58:57,800 OWE NANOPARTICLES THAT I DON'T 2808 01:58:57,800 --> 01:59:01,320 KNOW IF YOU KNOW THIS BUT AMONG 2809 01:59:01,320 --> 01:59:04,840 THE 14 NIH-SUPPORTED PATENTS 2810 01:59:04,840 --> 01:59:09,600 SUBMITTED BY DREW WEISMAN AND 2811 01:59:09,600 --> 01:59:11,560 HIS GROUP AT PENN BEFORE MODERNA 2812 01:59:11,560 --> 01:59:16,400 WAS EVEN IN THIS FIELD, NINE OF 2813 01:59:16,400 --> 01:59:17,360 THOSE PATENTS CITE THIS 2814 01:59:17,360 --> 01:59:20,080 INNOVATION GRANT IN 2016. 2815 01:59:20,080 --> 01:59:22,920 SO, IT'S NOT LIKE THIS IS IN A 2816 01:59:22,920 --> 01:59:23,520 VACUUM. 2817 01:59:23,520 --> 01:59:24,600 THESE GRANTS GO SOMEWHERE. 2818 01:59:24,600 --> 01:59:26,720 NOT ALL OF THEM, OBVIOUSLY, MOST 2819 01:59:26,720 --> 01:59:28,160 OF THEM FAIL ACTUALLY, THEY 2820 01:59:28,160 --> 01:59:30,920 DON'T GO ANYWHERE, THEY GET 2821 01:59:30,920 --> 01:59:31,440 FUNDED. 2822 01:59:31,440 --> 01:59:33,760 BUT THEY GO SOMEWHERE AND SAME 2823 01:59:33,760 --> 01:59:36,800 WITH THE PICKER SCOTT HANSON 2824 01:59:36,800 --> 01:59:41,000 APPROACH WITH CMV I FAILED TO 2825 01:59:41,000 --> 01:59:42,640 MENTION THEY'RE BOTH IN CLINICAL 2826 01:59:42,640 --> 01:59:44,200 TRIALS, RIGHT. 2827 01:59:44,200 --> 01:59:46,560 IN ONE WAY OR ANOTHER. 2828 01:59:46,560 --> 01:59:49,200 THE GROUP IS TESTING THE CMV 2829 01:59:49,200 --> 01:59:52,960 VECTOR AND A LOT OF THAT WORK 2830 01:59:52,960 --> 01:59:54,920 WAS -- SO, IN TERMS OF SNAP-H 2831 01:59:54,920 --> 01:59:56,720 AND HOW IT WILL COMMUNICATE WITH 2832 01:59:56,720 --> 01:59:58,920 THE INNOVATION GRANT PROGRAM, 2833 01:59:58,920 --> 02:00:00,880 WHICH WILL WE HOPE WILL ALSO 2834 02:00:00,880 --> 02:00:03,560 INCLUDE FURTHER DEVELOPMENT OF 2835 02:00:03,560 --> 02:00:05,600 NUCLEIC ACID-BASED VACCINES NOT 2836 02:00:05,600 --> 02:00:08,080 JUST RNA BUT DNA WE'LL HAVE TO 2837 02:00:08,080 --> 02:00:09,960 SEE WHERE IT GOES. 2838 02:00:09,960 --> 02:00:12,680 WE WON'T TURN DOWN FURTHER 2839 02:00:12,680 --> 02:00:13,680 DEVELOPMENTAL ASPECTS. 2840 02:00:13,680 --> 02:00:15,760 I MEAN WHAT'S DREW WISEMAN DID 2841 02:00:15,760 --> 02:00:18,760 OVER MANY YEARS, HIS INNOVATION 2842 02:00:18,760 --> 02:00:22,640 GRANT THAT WAS AWARDED IN 2016, 2843 02:00:22,640 --> 02:00:24,440 ACTUALLY GOT TWO NO-COST 2844 02:00:24,440 --> 02:00:25,640 EXTENSIONS AND ITS FINAL REPORT 2845 02:00:25,640 --> 02:00:29,400 I JUST GOT LIKE LAST MONTH. 2846 02:00:29,400 --> 02:00:30,920 EVEN THOUGH IT WAS FUNDED SIX 2847 02:00:30,920 --> 02:00:31,920 YEARS AGO. 2848 02:00:31,920 --> 02:00:34,720 AND HE HAD ALSO DONE ALL KINDS 2849 02:00:34,720 --> 02:00:36,160 OF DEVELOPMENTAL WORK, 2850 02:00:36,160 --> 02:00:40,720 ESPECIALLY THE MODIFICATIONS OF 2851 02:00:40,720 --> 02:00:49,440 THE PSEUDO URIDINE FOR THE 2852 02:00:49,440 --> 02:00:53,080 INNATE SYSTEM SO I HOSTED DREW 2853 02:00:53,080 --> 02:00:55,440 WISEMAN IN 2014 AND HE WAS ONE 2854 02:00:55,440 --> 02:00:56,480 OF THE THINGS HE WAS HOT ABOUT 2855 02:00:56,480 --> 02:00:58,480 THEN WAS SHOWING THE 2856 02:00:58,480 --> 02:00:59,600 NANOPARTICLES BY THEMSELVES 2857 02:00:59,600 --> 02:01:01,640 COULD BE ADJUVANTS AND 2858 02:01:01,640 --> 02:01:04,520 INDEPENDENT OF THE mRNA SO 2859 02:01:04,520 --> 02:01:06,720 THAT WORK HAS BEEN TAKEN ON BY 2860 02:01:06,720 --> 02:01:09,160 OTHER GRANT MECHANISMS AND 2861 02:01:09,160 --> 02:01:10,560 EXPANDED EXTENSIVELY AND WE'RE 2862 02:01:10,560 --> 02:01:11,880 CERTAINLY GOING TO COMMUNICATE 2863 02:01:11,880 --> 02:01:15,200 THAT IF THE SNAP-H GETS TRACTION 2864 02:01:15,200 --> 02:01:18,320 WE HOPE TO CERTAINLY INTERACT 2865 02:01:18,320 --> 02:01:18,840 GOING FORWARD. 2866 02:01:18,840 --> 02:01:19,640 >> GREAT. 2867 02:01:19,640 --> 02:01:22,800 JOHN, WE HAVE A QUESTION FROM 2868 02:01:22,800 --> 02:01:23,400 Dr. HARRIS. 2869 02:01:23,400 --> 02:01:26,280 >> JUST KIND OF A COMMENT AND A 2870 02:01:26,280 --> 02:01:26,880 QUESTION. 2871 02:01:26,880 --> 02:01:29,480 SO, INNOVATION BEING KEY NOVEL 2872 02:01:29,480 --> 02:01:31,440 BEING KEY, MY QUESTION IS 2873 02:01:31,440 --> 02:01:33,080 RELATED TO KEITH'S WAY AND IT 2874 02:01:33,080 --> 02:01:34,360 WOULD BE REALLY NICE IF THE 2875 02:01:34,360 --> 02:01:35,320 DIFFERENT PROGRAMS COULD TALK 2876 02:01:35,320 --> 02:01:39,160 AND HELP THE PIs DETERMINE 2877 02:01:39,160 --> 02:01:41,840 WHICH, YOU KNOW, FOA IS MORE 2878 02:01:41,840 --> 02:01:44,200 APPROPRIATE FOR THEIR INNOVATIVE 2879 02:01:44,200 --> 02:01:44,600 PROPOSAL. 2880 02:01:44,600 --> 02:01:45,840 BECAUSE THERE IS ACTUALLY QUITE 2881 02:01:45,840 --> 02:01:47,640 A NICE THEME THAT IS EMERGING 2882 02:01:47,640 --> 02:01:55,680 HERE BETWEEN THEM BUT I THINK -- 2883 02:01:55,680 --> 02:01:56,040 YOU FROZE UP. 2884 02:01:56,040 --> 02:01:58,040 CAN YOU HEAR ME? 2885 02:01:58,040 --> 02:02:00,320 >> RUBEN, YOU JUST FROZE SO YOU 2886 02:02:00,320 --> 02:02:03,560 WILL UNFREEZE AT SOME POINT 2887 02:02:03,560 --> 02:02:03,760 AND -- 2888 02:02:03,760 --> 02:02:08,720 >> I THOUGHT I FROZE UP. 2889 02:02:08,720 --> 02:02:10,480 >> I'M NOT SURE WHAT HE WAS 2890 02:02:10,480 --> 02:02:10,920 GETTING AT. 2891 02:02:10,920 --> 02:02:12,840 >> WELL, HE WILL COMMUNICATE BY 2892 02:02:12,840 --> 02:02:14,400 CHAT AND THEN WHEN ALWAYS 2893 02:02:14,400 --> 02:02:16,040 FREEZES IN JUST THE MOST 2894 02:02:16,040 --> 02:02:19,480 WONDERFUL POSITIONS THAT WE CAN 2895 02:02:19,480 --> 02:02:19,720 HAVE. 2896 02:02:19,720 --> 02:02:21,040 ZOOM SHOULD ALLOW TO YOU CHOSE 2897 02:02:21,040 --> 02:02:24,120 WHEN YOU FREEZE HOW YOU FREEZE. 2898 02:02:24,120 --> 02:02:25,600 ALL RIGHT. 2899 02:02:25,600 --> 02:02:29,080 WELL, HERE HE GOES. 2900 02:02:29,080 --> 02:02:30,280 ARE YOU BACK? 2901 02:02:30,280 --> 02:02:32,440 >> SO MY BRANCH CHIEF HAS A 2902 02:02:32,440 --> 02:02:35,160 COMMENT IN THE CHAT THAT MAYBE 2903 02:02:35,160 --> 02:02:37,880 PRELIMINARY DATA IS THE KEY SO, 2904 02:02:37,880 --> 02:02:40,880 ONE OF THE THINGS DISCUSSED IN 2905 02:02:40,880 --> 02:02:43,960 OUR CALL WITH THE REVIEWERS WAS 2906 02:02:43,960 --> 02:02:47,240 YOU KNOW, THE DEGREE OF 2907 02:02:47,240 --> 02:02:51,600 PRELIMINARY DATA OR THIS IDEA 2908 02:02:51,600 --> 02:02:53,560 THAT THOSE KINDS OF DATA ARE NOT 2909 02:02:53,560 --> 02:02:56,360 NECESSARILY NEEDED FOR AN 2910 02:02:56,360 --> 02:03:00,360 APPLICATION FOR THIS IHVD AND IN 2911 02:03:00,360 --> 02:03:02,040 MY EXPERIENCE, ALL THESE GRANTS 2912 02:03:02,040 --> 02:03:03,440 COME IN WITH SOME PRELIMINARY 2913 02:03:03,440 --> 02:03:04,720 DATA AND SOMETIMES IT'S 2914 02:03:04,720 --> 02:03:06,120 RELEGATED TO OTHER DISEASE 2915 02:03:06,120 --> 02:03:07,800 SYSTEMS USING THAT APPROACH THAT 2916 02:03:07,800 --> 02:03:11,960 THEY WANT TO APPLY TO HIV. 2917 02:03:11,960 --> 02:03:13,600 SO, WE'RE VERY SERIOUS, THESE 2918 02:03:13,600 --> 02:03:15,960 GET REVIEWED IN BLOCK IN A BLOCK 2919 02:03:15,960 --> 02:03:20,880 WITHIN THE CSR/RO1 REVIEW PANEL 2920 02:03:20,880 --> 02:03:25,480 AND SO THESE ARE REVIEWED AS A 2921 02:03:25,480 --> 02:03:27,600 GROUP AND THE SRO OR THE CHAIR 2922 02:03:27,600 --> 02:03:30,560 IS CAREFUL TO REMIND THE 2923 02:03:30,560 --> 02:03:32,720 REVIEWERS OF THIS FACT THAT THE 2924 02:03:32,720 --> 02:03:34,000 PRELIMINARY DATA AREN'T 2925 02:03:34,000 --> 02:03:35,320 NECESSARILY HAVE TO BE AS 2926 02:03:35,320 --> 02:03:38,200 RIGOROUS AS A TYPICAL RO1. 2927 02:03:38,200 --> 02:03:39,440 >> GREAT. 2928 02:03:39,440 --> 02:03:41,560 THANK YOU Dr. WARREN AND THANK 2929 02:03:41,560 --> 02:03:44,480 YOU FOR REMINDING US THAT FOR 2930 02:03:44,480 --> 02:03:46,760 HIGH-RISK PROPOSALS, THAT SIX 2931 02:03:46,760 --> 02:03:49,960 MOVING ON OUST 30 IS A HIGH 2932 02:03:49,960 --> 02:03:51,480 YIELD AND THEN A PROGRESS BEYOND 2933 02:03:51,480 --> 02:03:54,720 THAT SO LET ME ASK PEOPLE TO 2934 02:03:54,720 --> 02:03:56,720 VOTE IF YOU HAVEN'T ALREADY 2935 02:03:56,720 --> 02:03:57,720 VOTED. 2936 02:03:57,720 --> 02:03:58,440 HOPEFULLY PEOPLE HAVE AND WE 2937 02:03:58,440 --> 02:04:03,280 WILL GET Dr. HARRIS BACK AT 2938 02:04:03,280 --> 02:04:04,680 SOME POINT. 2939 02:04:04,680 --> 02:04:06,960 AND I THINK WE WILL MOVE ON TO 2940 02:04:06,960 --> 02:04:11,160 THE LAST CONCEPT FOR THE VACCINE 2941 02:04:11,160 --> 02:04:12,440 RESEARCH PROGRAM ENTITLED 2942 02:04:12,440 --> 02:04:14,000 INTEGRATED PRE CLINICAL CLINICAL 2943 02:04:14,000 --> 02:04:16,560 AIDS VACCINE DEVELOPMENT IPCAVD 2944 02:04:16,560 --> 02:04:18,320 PROGRAM AND A U19. 2945 02:04:18,320 --> 02:04:23,520 WE'LL BE PRESENTED BY Dr. 2946 02:04:23,520 --> 02:04:23,720 VIJH. 2947 02:04:23,720 --> 02:04:24,200 >> THANK YOU. 2948 02:04:24,200 --> 02:04:25,080 CAN YOU HEAR ME? 2949 02:04:25,080 --> 02:04:25,960 >> YES. 2950 02:04:25,960 --> 02:04:28,120 >> GREAT. 2951 02:04:28,120 --> 02:04:29,080 HELLO, EVERYONE. 2952 02:04:29,080 --> 02:04:31,560 I AM GOING TO PRESENT, IT'S MY 2953 02:04:31,560 --> 02:04:33,640 PRIVILEGE TO PRESENT THE FISCAL 2954 02:04:33,640 --> 02:04:36,720 YEAR 24 CONCEPT INTEGRATED PRE 2955 02:04:36,720 --> 02:04:37,560 CLINICAL/CLINICAL AIDS VACCINE 2956 02:04:37,560 --> 02:04:38,600 DEVELOPMENT PROGRAM. 2957 02:04:38,600 --> 02:04:40,200 THROUGHOUT THE PRESENTATION, I 2958 02:04:40,200 --> 02:04:45,600 WILL USE IPCAVD TO REFER TO THE 2959 02:04:45,600 --> 02:04:45,960 CONCEPT. 2960 02:04:45,960 --> 02:04:48,880 THE IPCAVD IS A LONGSTANDING 2961 02:04:48,880 --> 02:04:50,840 PROGRAM INITIATED IN 1998 AND 2962 02:04:50,840 --> 02:04:52,120 HAS EVOLVED OVER THE YEARS TO 2963 02:04:52,120 --> 02:04:53,080 THE CURRENT STATE. 2964 02:04:53,080 --> 02:04:55,120 THIS IS A REQUEST TO COUNCIL FOR 2965 02:04:55,120 --> 02:04:56,720 APPROVAL OF REISSUE. 2966 02:04:56,720 --> 02:04:59,520 THIS IS A U19 GRANT MECHANISM. 2967 02:04:59,520 --> 02:05:01,800 WHICH IS ACTUALLY A CO-OPERATIVE 2968 02:05:01,800 --> 02:05:02,440 AGREEMENT WHICH REQUIRES 2969 02:05:02,440 --> 02:05:04,360 SIGNIFICANT OVERSIGHT BY 2970 02:05:04,360 --> 02:05:04,760 PROGRAMS. 2971 02:05:04,760 --> 02:05:07,040 A MINIMUM OF TWO PROJECTS THAT I 2972 02:05:07,040 --> 02:05:09,040 SCIENTIFIC PROJECTS AND 2973 02:05:09,040 --> 02:05:10,200 ADMINISTRATIVE CORE ARE 2974 02:05:10,200 --> 02:05:10,600 REQUIRED. 2975 02:05:10,600 --> 02:05:13,000 AND ONE OF THE PROJECT TEST TO 2976 02:05:13,000 --> 02:05:14,720 FOCUS ON MANUFACTURING. 2977 02:05:14,720 --> 02:05:16,120 THE FIRST YEAR TOTAL COST FOR 2978 02:05:16,120 --> 02:05:17,960 THIS CONCEPT IS $4 MILLION. 2979 02:05:17,960 --> 02:05:20,360 FOR A DURATION OF FIVE YEARS. 2980 02:05:20,360 --> 02:05:21,680 AND THE ANTICIPATED NUMBER OF 2981 02:05:21,680 --> 02:05:28,320 AWARDS IS ONE TO TWO. 2982 02:05:28,320 --> 02:05:30,440 THE PURPOSE OF THE REVIEW IS TO 2983 02:05:30,440 --> 02:05:32,920 FACILITATE TRANSLATION OF 2984 02:05:32,920 --> 02:05:34,120 ADVANCED HIV VACCINE CANDIDATES 2985 02:05:34,120 --> 02:05:36,920 FROM PRE CLINICAL STUDIES ALL 2986 02:05:36,920 --> 02:05:39,760 THE WAY THROUGH MANUFACTURING 2987 02:05:39,760 --> 02:05:40,720 REGULATORY FILING UP TO THE 2988 02:05:40,720 --> 02:05:43,560 POINT OF CLINICAL TESTING AND 2989 02:05:43,560 --> 02:05:45,000 CLINICAL TRIALS BEEN BE 2990 02:05:45,000 --> 02:05:45,360 SUPPORTED. 2991 02:05:45,360 --> 02:05:46,960 THE OBJECTIVES OF THE PROGRAM 2992 02:05:46,960 --> 02:05:49,920 ARE, TRANSLATION OF VACCINE 2993 02:05:49,920 --> 02:05:51,920 PLATFORMS THAT ILLICIT PRIMARILY 2994 02:05:51,920 --> 02:05:53,680 BROADLY NEUTRALIZING ANTIBODIES 2995 02:05:53,680 --> 02:05:55,680 AND DOWN-SELECTION OF MA CURE 2996 02:05:55,680 --> 02:05:58,800 HIV VACCINE CANDIDATES BY A 2997 02:05:58,800 --> 02:05:59,600 MULTI-DISCIPLINARY GROUP OF 2998 02:05:59,600 --> 02:06:02,320 EXPERTS SUCH AS IMMUNOLOGIST, 2999 02:06:02,320 --> 02:06:05,040 STRUCTURE BIOLOGISTS AND ANIMAL 3000 02:06:05,040 --> 02:06:06,920 MODELERS, AND OTHERS. 3001 02:06:06,920 --> 02:06:08,960 AND ANOTHER OBJECTIVE IS FOR 3002 02:06:08,960 --> 02:06:10,480 CLINICAL TRIAL READINESS FOR 3003 02:06:10,480 --> 02:06:12,360 TESTING HYPOTHESIS-DRIVEN PROOF 3004 02:06:12,360 --> 02:06:16,280 OF CONCEPT USING THE CGMP 3005 02:06:16,280 --> 02:06:18,560 MANUFACTURED PRODUCTS IN 3006 02:06:18,560 --> 02:06:19,960 EXPERIMENTAL TID PHASE ONE 3007 02:06:19,960 --> 02:06:21,160 CLINICAL TRIALS. 3008 02:06:21,160 --> 02:06:23,200 GIVEN THE RELUCTANCE OF INDUSTRY 3009 02:06:23,200 --> 02:06:24,760 TO TAKE FINANCIAL RISKS TO 3010 02:06:24,760 --> 02:06:27,680 INVEST IN HIV VACCINE 3011 02:06:27,680 --> 02:06:30,760 DEVELOPMENT, THE MAIN OBJECTIVE 3012 02:06:30,760 --> 02:06:33,320 OF THE IPCAVD IS TO POSTER 3013 02:06:33,320 --> 02:06:34,880 PARTNERSHIPS BETWEEN ACADEMIC 3014 02:06:34,880 --> 02:06:36,480 THAT BRINGS IDEAS AND INNOVATION 3015 02:06:36,480 --> 02:06:39,040 TO THE TABLE, PHARMA, BIOTECH, 3016 02:06:39,040 --> 02:06:40,320 CONTRACT MANUFACTURING AND 3017 02:06:40,320 --> 02:06:41,600 ORGANIZATION THAT'S PROVIDE THE 3018 02:06:41,600 --> 02:06:44,640 MANUFACTURING KNOW HOW AND DAIT 3019 02:06:44,640 --> 02:06:47,040 THAT PROVIDE LEADERSHIP TO INSEN 3020 02:06:47,040 --> 02:06:48,320 TA VIVE COMMERCIAL PARTNERS AND 3021 02:06:48,320 --> 02:06:54,640 DERISK HIV DEVELOPMENT. 3022 02:06:54,640 --> 02:06:56,680 I'D LIKE TO PROVIDE AN OVERSIGHT 3023 02:06:56,680 --> 02:07:00,840 OF THE TRANSLATIONAL RESEARCH 3024 02:07:00,840 --> 02:07:04,000 AND THE ACTIVITIES. 3025 02:07:04,000 --> 02:07:06,800 THIS REQUIRES MULTI-DISCIPLINARY 3026 02:07:06,800 --> 02:07:08,480 TEAMS FROM ALL STAKEHOLDERS 3027 02:07:08,480 --> 02:07:09,880 INCLUDING DAIDS, INDUSTRY AND 3028 02:07:09,880 --> 02:07:11,440 THE GRANTEE ORGANIZATION AND 3029 02:07:11,440 --> 02:07:13,600 ALSO REQUIRES EXCELLENT PROJECT 3030 02:07:13,600 --> 02:07:19,960 MANAGERS AND COMMUNICATION 3031 02:07:19,960 --> 02:07:20,720 SKILLS. 3032 02:07:20,720 --> 02:07:22,000 OVER SUES SOUP TO NUTS 3033 02:07:22,000 --> 02:07:22,400 MANUFACTURING. 3034 02:07:22,400 --> 02:07:24,320 IN YEARS ONE TO THREE THE 3035 02:07:24,320 --> 02:07:27,360 GRANTEE FOCUSES ON THE APP 3036 02:07:27,360 --> 02:07:28,640 TIMIZATION STUDIES IN PRE 3037 02:07:28,640 --> 02:07:30,240 CLINICAL MODELS COULD BE SMALL 3038 02:07:30,240 --> 02:07:34,360 ANIMAL MODELING LIKE TRANSGENIC 3039 02:07:34,360 --> 02:07:37,200 MICE AND LARGER ANIMALS LIKE NON 3040 02:07:37,200 --> 02:07:38,160 HUMAN PRIMATES. 3041 02:07:38,160 --> 02:07:40,040 THIS GOES THROUGH DOWN SELECTION 3042 02:07:40,040 --> 02:07:42,920 AND AS WELL AS DECISION AND 3043 02:07:42,920 --> 02:07:43,600 MANUFACTURE ABILITY AND THROUGH 3044 02:07:43,600 --> 02:07:46,640 PRE IND AS WELL AS IND ENABLING 3045 02:07:46,640 --> 02:07:47,920 STUDIES AND IN YEARS THREE TO 3046 02:07:47,920 --> 02:07:51,000 FIVE, BASED ON THE RESEARCH 3047 02:07:51,000 --> 02:07:51,600 GREAT EXPRESSION AND DECISION 3048 02:07:51,600 --> 02:07:54,680 FOR MANUFACTURING ABILITY, THERE 3049 02:07:54,680 --> 02:07:56,840 COULD BE LARGER SCALE RUNS THAT 3050 02:07:56,840 --> 02:07:58,600 TAKE PLACE AND THERE COULD BE 3051 02:07:58,600 --> 02:07:59,800 DEMONSTRATION RUNS AND 3052 02:07:59,800 --> 02:08:04,040 ENGINEERING RUNS LEADING UP TO 3053 02:08:04,040 --> 02:08:05,000 CGMP MANUFACTURING. 3054 02:08:05,000 --> 02:08:07,640 THERE'S A LOT OF OVERSIGHT OF 3055 02:08:07,640 --> 02:08:10,960 DEVELOPMENT OF ANALYTICAL ASSAYS 3056 02:08:10,960 --> 02:08:13,960 METHOD DEVELOPMENT, UPSTREAM AND 3057 02:08:13,960 --> 02:08:16,520 DOWNSTREAM PROCESS DEVELOPMENT, 3058 02:08:16,520 --> 02:08:17,520 QUALITY ASSURANCE AS WELL AS 3059 02:08:17,520 --> 02:08:19,520 REGULATORY AND IND APPLICATION. 3060 02:08:19,520 --> 02:08:22,360 THIS RESULTS IN INVENTORY, 3061 02:08:22,360 --> 02:08:24,120 MULTIPLE INVENTORY AS WELL AS A 3062 02:08:24,120 --> 02:08:27,280 CLINICAL PRODUCT THAT WILL BE 3063 02:08:27,280 --> 02:08:28,960 VILE AND REQUIRES SHORT TERM AND 3064 02:08:28,960 --> 02:08:32,080 LONG-TERM STORAGE OF PRODUCTS 3065 02:08:32,080 --> 02:08:34,040 AND MATERIALS AND A STABILITY 3066 02:08:34,040 --> 02:08:35,400 PROGRAM THAT FOLLOWS GUIDANCE. 3067 02:08:35,400 --> 02:08:38,200 WHEN THE PRODUCT IS AROUND 3068 02:08:38,200 --> 02:08:42,080 THERE'S A HAND OFF OUTSIDE THE 3069 02:08:42,080 --> 02:08:43,280 IPCAVD PROGRAM AND I'M SHOWING 3070 02:08:43,280 --> 02:08:44,640 THIS AT THE BOTTOM. 3071 02:08:44,640 --> 02:08:48,920 THERE'S A SEPARATION OF THE 3072 02:08:48,920 --> 02:08:49,960 IPCAVD ACTIVITIES FROM TESTING 3073 02:08:49,960 --> 02:08:57,720 IN THE CLINIC. 3074 02:08:57,720 --> 02:09:02,920 SO, THE IMPORTANCE OF THE IPCAVD 3075 02:09:02,920 --> 02:09:04,920 IT HAS FOSTERED SEVERAL AND 3076 02:09:04,920 --> 02:09:07,040 UNIQUE PARTNERSHIPS BETWEEN 3077 02:09:07,040 --> 02:09:08,240 ACADEMIC AND DAIDS THAT WOULD 3078 02:09:08,240 --> 02:09:09,400 NOT HAVE OCCURRED WITHOUT THIS 3079 02:09:09,400 --> 02:09:10,960 MECHANISM AND I WILL SHOW YOU A 3080 02:09:10,960 --> 02:09:12,560 FIE EXAMPLES IN THE FOLLOWING 3081 02:09:12,560 --> 02:09:12,800 SLIDES. 3082 02:09:12,800 --> 02:09:14,440 HIV VACCINE DEVELOPMENT IS AT A 3083 02:09:14,440 --> 02:09:14,960 CROSS ROADS. 3084 02:09:14,960 --> 02:09:20,720 GIVEN THE RESULTS OF 703, 703 3085 02:09:20,720 --> 02:09:23,320 AND 4 THE M.P. TRIALS AND 705 3086 02:09:23,320 --> 02:09:24,200 THE TRIALS. 3087 02:09:24,200 --> 02:09:26,440 THIS PRESENTS AN OPPORTUNITY FOR 3088 02:09:26,440 --> 02:09:28,560 US TO TAKE LESSONS LEARNED FROM 3089 02:09:28,560 --> 02:09:30,000 THESE TRIALS AND AS WELL AS 3090 02:09:30,000 --> 02:09:32,160 APPLY STATE OF THE ART 3091 02:09:32,160 --> 02:09:33,280 TECHNOLOGIES GIVEN THE SUCCESSES 3092 02:09:33,280 --> 02:09:37,040 OF THE COVID-19 VACCINE FIELD 3093 02:09:37,040 --> 02:09:43,440 WITH SHORTER MANUFACTURING TIME 3094 02:09:43,440 --> 02:09:44,680 LINES. 3095 02:09:44,680 --> 02:09:46,120 IT'S A STREAM LINE 3096 02:09:46,120 --> 02:09:47,520 INVESTIGATOR-DRIVEN APPROACH TO 3097 02:09:47,520 --> 02:09:49,080 ADVANCE VACCINE RESEARCH 3098 02:09:49,080 --> 02:09:50,760 CONCEPTS FORWARD FOR TESTING AND 3099 02:09:50,760 --> 02:09:52,520 THERE IS NO SIMILAR MECHANISM 3100 02:09:52,520 --> 02:09:55,920 THAT SUPPORTS AN 3101 02:09:55,920 --> 02:09:56,520 INVESTIGATOR-INITIATED UTTER A 3102 02:09:56,520 --> 02:09:58,920 TIVE MULTI-DISCIPLINARY TEAM 3103 02:09:58,920 --> 02:10:01,320 BASED TRANSLATIONAL PROGRAM THAT 3104 02:10:01,320 --> 02:10:03,200 IS SYSTEMATIC AND INTEGRATED AS 3105 02:10:03,200 --> 02:10:06,200 THE IPCAVD. 3106 02:10:06,200 --> 02:10:08,080 DAIDS DOES PROVIDE A 3107 02:10:08,080 --> 02:10:09,000 COMPLIMENTARY APPROACH WHICH IS 3108 02:10:09,000 --> 02:10:10,680 A CONTRACT MECHANISM THAT IS 3109 02:10:10,680 --> 02:10:11,880 GAP-FILLING FOR VACCINE CONCEPTS 3110 02:10:11,880 --> 02:10:14,480 AND IT'S A SUPPORT CONTRACT AND 3111 02:10:14,480 --> 02:10:18,720 IT'S TASK-ORIENTED AND IT'S A 3112 02:10:18,720 --> 02:10:22,360 MULTI-ID/IQ WHICH IS INDEFINITE 3113 02:10:22,360 --> 02:10:25,680 QUANTITY AND PTVDS CONTRACT AND 3114 02:10:25,680 --> 02:10:27,320 THIS ONE, THIS IS A DELIVERABLE 3115 02:10:27,320 --> 02:10:29,320 TO THE GOVERNMENT AND THE FUNDS 3116 02:10:29,320 --> 02:10:31,920 ARE NOT PROVIDED TO THE GRANTEE. 3117 02:10:31,920 --> 02:10:34,520 SORRY, NOT TO THE GRANTEE BUT TO 3118 02:10:34,520 --> 02:10:37,120 THE BIOTECH COMPANY OR ANY 3119 02:10:37,120 --> 02:10:39,720 INVESTIGATOR THAT MAY WANT TO 3120 02:10:39,720 --> 02:10:41,880 GET SOME PRODUCT FILLED AS WELL 3121 02:10:41,880 --> 02:10:43,480 AS DAIDS MAY DECIDE THAT THEY 3122 02:10:43,480 --> 02:10:45,600 WOULD LIKE SOME PRODUCT TO BE 3123 02:10:45,600 --> 02:10:46,000 FILLED. 3124 02:10:46,000 --> 02:10:49,480 NEXT SLIDE, PLEASE. 3125 02:10:49,480 --> 02:10:51,120 IN THE NEXT TWO SLIDES, I WILL 3126 02:10:51,120 --> 02:10:54,880 BE PRESENTING AN OVERVIEW OF THE 3127 02:10:54,880 --> 02:10:56,920 PROGRAMS IN THE LAST 15 YEARS OF 3128 02:10:56,920 --> 02:10:59,200 THE 24 YEARS IT HAS BEEN IN 3129 02:10:59,200 --> 02:11:00,840 EXISTENCE. 3130 02:11:00,840 --> 02:11:07,040 SINCE 1998, TO PRESENT, 33ICCAVD 3131 02:11:07,040 --> 02:11:08,240 AWARDS HAVE BEEN MADE AND THERE 3132 02:11:08,240 --> 02:11:09,440 ARE SEVEN ACTIVE AWARDS. 3133 02:11:09,440 --> 02:11:11,040 THE ACTIVE AWARDS ARE SHOWN IN 3134 02:11:11,040 --> 02:11:13,520 THE SLIDE IN THE YELLOW AS WELL 3135 02:11:13,520 --> 02:11:15,000 AS CORRELATES WITH A OLD TEXT OF 3136 02:11:15,000 --> 02:11:17,560 THE YEAR IT WAS AWARDED AND THE 3137 02:11:17,560 --> 02:11:19,080 YEARS THAT ARE GRAYED OUT 3138 02:11:19,080 --> 02:11:21,840 INDICATES THAT THE AWARD HAS 3139 02:11:21,840 --> 02:11:22,040 ENDED. 3140 02:11:22,040 --> 02:11:24,160 I WOULD ALSO LIKE TO STATE THAT 3141 02:11:24,160 --> 02:11:26,640 THE LINE THAT IS DIVIDING IS 3142 02:11:26,640 --> 02:11:29,360 BASICALLY GROUPING THE DIFFERENT 3143 02:11:29,360 --> 02:11:31,120 IMMUNOGEN DESIGNS SO UP ON THE 3144 02:11:31,120 --> 02:11:32,880 UPPER HALF YOU CAN SEE THE 3145 02:11:32,880 --> 02:11:35,400 VECTOR PLATFORMS WHERE THE LOWER 3146 02:11:35,400 --> 02:11:43,440 HALF IS DESIGN AND I WON'T MENTN 3147 02:11:43,440 --> 02:11:44,520 ALL THE PROGRAMS AND JUST BE 3148 02:11:44,520 --> 02:11:46,960 SELECTIVE TO GET THE POINT 3149 02:11:46,960 --> 02:11:47,200 ACROSS. 3150 02:11:47,200 --> 02:11:50,960 I WOULD LIKE TO FOCUS ON THE 3151 02:11:50,960 --> 02:11:53,440 TRANSLATIONAL OF THE HOWARD 3152 02:11:53,440 --> 02:11:56,160 MEDICAL CENTER PROGRAM. 3153 02:11:56,160 --> 02:11:59,800 Dr. RECEIVED FOUR IPCAVD AWARD 3154 02:11:59,800 --> 02:12:01,880 OVER THE MANY YEARS IN THE 3155 02:12:01,880 --> 02:12:04,320 INITIAL STAGES OF 2005, THIS WAS 3156 02:12:04,320 --> 02:12:07,560 A HEAD-TO-HEAD COMPARISON WITH 3157 02:12:07,560 --> 02:12:11,160 THE 26 ZERO TYPES THAT IS AT 26, 3158 02:12:11,160 --> 02:12:14,520 35, 48 TO DOWN SELECT TO AT 26 3159 02:12:14,520 --> 02:12:16,360 WITH CELL SUBSTRATES AND 3160 02:12:16,360 --> 02:12:17,880 RESULTED IN MANUFACTURING OF 3161 02:12:17,880 --> 02:12:20,040 SMALL SCALE PHASE 1 MATERIAL AND 3162 02:12:20,040 --> 02:12:23,120 IN 2008, IT SUPPORTED AR26 3163 02:12:23,120 --> 02:12:24,880 PLATFORM DEVELOPMENT AND SCALE 3164 02:12:24,880 --> 02:12:27,400 UP OF THE ADD 26 MOSAIC ENVELOPE 3165 02:12:27,400 --> 02:12:30,240 PROCESSES FOR PHASE 2 AND ALSO 3166 02:12:30,240 --> 02:12:31,760 ENGAGE THAT MADE SIGNIFICANT 3167 02:12:31,760 --> 02:12:34,480 FINANCIAL COMMITMENTS AT 3168 02:12:34,480 --> 02:12:35,080 JANSSEN. 3169 02:12:35,080 --> 02:12:36,640 IN 2012, THE LATER YEARS, 3170 02:12:36,640 --> 02:12:39,360 DEVELOP MANUFACTURING PROCESSES 3171 02:12:39,360 --> 02:12:41,240 FOR GENERATE B AND C FOLD ON 3172 02:12:41,240 --> 02:12:43,960 TRIMER AS GP140 PROTEIN BOOST 3173 02:12:43,960 --> 02:12:48,360 AND BY THEN, THEY HAD BOUGHT OUT 3174 02:12:48,360 --> 02:12:50,160 CREW SELL SO THESE EFFORTS 3175 02:12:50,160 --> 02:12:51,440 FOSTERED MANY PARTNERSHIPS THAT 3176 02:12:51,440 --> 02:12:54,520 RESULTED IN EFFICACY TRIALS AND 3177 02:12:54,520 --> 02:12:57,080 705 AS YOU KNOW HAS BEEN 3178 02:12:57,080 --> 02:12:58,000 COMPLETED. 3179 02:12:58,000 --> 02:13:00,520 AND 706 THAT IS CURRENT LEON 3180 02:13:00,520 --> 02:13:02,560 GOING, THIS IS THE TRIAL. 3181 02:13:02,560 --> 02:13:03,840 FURTHERMORE, AS YOU ALREADY 3182 02:13:03,840 --> 02:13:06,040 KNOW, THIS IS ALSO ACCELERATED 3183 02:13:06,040 --> 02:13:08,160 THE COVID-19 R26 PLATFORM AS A 3184 02:13:08,160 --> 02:13:09,960 PLUG AND PLAY WITH LESSONS 3185 02:13:09,960 --> 02:13:14,720 LEARNED FROM THE HIV VACCINE 3186 02:13:14,720 --> 02:13:15,440 FIELD. 3187 02:13:15,440 --> 02:13:16,280 THE PROGRAM HAS BEEN MENTIONED 3188 02:13:16,280 --> 02:13:19,280 PREVIOUSLY BY MY COLLEAGUES 3189 02:13:19,280 --> 02:13:19,560 PREVIOUSLY. 3190 02:13:19,560 --> 02:13:24,240 THIS IS THE OREGON HEALTH 3191 02:13:24,240 --> 02:13:24,520 SCIENCES. 3192 02:13:24,520 --> 02:13:26,560 IT WAS USED FOR FILL FINISH OF 3193 02:13:26,560 --> 02:13:28,200 THE DRUG SUBSTANCE AND THIS 3194 02:13:28,200 --> 02:13:31,880 RESULTED IN A CD8 T-CELL VACCINE 3195 02:13:31,880 --> 02:13:35,240 USING THE ATTENUATED HUMAN CMV 3196 02:13:35,240 --> 02:13:36,840 VACCINE WHICH HAS BEEN TAKEN, 3197 02:13:36,840 --> 02:13:39,160 THE PROCESSES FROM THESE WERE 3198 02:13:39,160 --> 02:13:42,040 TAKE ON BY TECHNOLOGIES TO USED 3199 02:13:42,040 --> 02:13:45,320 THE PRODUCT VIR IN THE 22 TRIAL 3200 02:13:45,320 --> 02:13:48,720 GOING ON IN COLLABORATION WITH 3201 02:13:48,720 --> 02:13:50,480 THE BELINDA GATES FOUNDATION. 3202 02:13:50,480 --> 02:13:54,520 MOVING ON, THIS IS THE PROGRAM 3203 02:13:54,520 --> 02:13:57,600 AND HE ENGAGE INITIALLY PARA 3204 02:13:57,600 --> 02:13:59,840 GONE THAT WAS BY CAT A LYNN WHO 3205 02:13:59,840 --> 02:14:02,680 ENGINEERED A FOUR TO SIX 3206 02:14:02,680 --> 02:14:05,000 NANOPARTICLE AND THIS IS A JP120 3207 02:14:05,000 --> 02:14:07,640 AND IT'S THE GERM LINE TARGETING 3208 02:14:07,640 --> 02:14:10,640 THE VRCO1. 3209 02:14:10,640 --> 02:14:15,680 AND THIS ENTERED INTO THE CLINIC 3210 02:14:15,680 --> 02:14:18,440 IN 301 IN JULY OF THIS YEAR SO 3211 02:14:18,440 --> 02:14:25,640 TEST THE DOSING REGIMENT USING 3212 02:14:25,640 --> 02:14:29,200 3M052-ALUM AND IN 2022, Dr. 3213 02:14:29,200 --> 02:14:32,400 KEVIN SAUNDERS WAS AVOIDED BY 3214 02:14:32,400 --> 02:14:41,080 THE FOR NA NANOPARTICLE PLATFOR. 3215 02:14:41,080 --> 02:14:43,640 I WOULD LIKE TO FOCUS BY Dr. 3216 02:14:43,640 --> 02:14:44,360 DAVID BARNER OF THE WEST STAR 3217 02:14:44,360 --> 02:14:51,280 THAT HAS PARTNERED WITH BIO 3218 02:14:51,280 --> 02:14:52,840 PHARMACEUTICALS OVER MANY YEARS 3219 02:14:52,840 --> 02:14:56,600 AND THE FINISH WAS BUN DID I IDT 3220 02:14:56,600 --> 02:15:06,320 RESULT INSIDE TWO DNA I AM OWE E 3221 02:15:06,320 --> 02:15:08,320 BEGINS AND THE OTHER 3222 02:15:08,320 --> 02:15:09,720 NANOPARTICLE AND THOSE WERE CO 3223 02:15:09,720 --> 02:15:13,160 FORMULATED WITH IL12 AS AN 3224 02:15:13,160 --> 02:15:16,240 ADJUVANT AND TESTED IN THE PRIME 3225 02:15:16,240 --> 02:15:17,560 PROTEIN BOOST. 3226 02:15:17,560 --> 02:15:21,120 IT WOULD BE TRIMER 4571 PROVIDED 3227 02:15:21,120 --> 02:15:25,400 BY THE CRC AND WITH 30M5 TOO 3228 02:15:25,400 --> 02:15:25,680 ALUM. 3229 02:15:25,680 --> 02:15:28,920 THE TWO TRIALS, 304 AND 305 WILL 3230 02:15:28,920 --> 02:15:31,680 START LATER THIS YEAR. 3231 02:15:31,680 --> 02:15:35,880 FINALLY COMING TO THE MRNA 3232 02:15:35,880 --> 02:15:37,680 PLATFORM, EVERYBODY IS FAMILIAR 3233 02:15:37,680 --> 02:15:42,000 WITH THE AWARD TO Dr. HAINES 3234 02:15:42,000 --> 02:15:45,800 AS WELL AS TO Dr. WAISMAN AND 3235 02:15:45,800 --> 02:15:47,720 Dr. HAINES WAS AWARDED TWO AND 3236 02:15:47,720 --> 02:15:51,640 BASICALLY TO PARTNER WITH BION 3237 02:15:51,640 --> 02:15:55,240 TECH, VEVONIK AND A VANITY AND 3238 02:15:55,240 --> 02:16:02,520 CURRENTLY THE FOCUS ON THE V3 3239 02:16:02,520 --> 02:16:04,400 GO-CH848 PRIME BOOST mRNA 3240 02:16:04,400 --> 02:16:07,000 BOOST PLATFORM. 3241 02:16:07,000 --> 02:16:09,480 AND AS YOU KNOW, AS YOU CAN SEE, 3242 02:16:09,480 --> 02:16:11,160 THESE WERE AWARDED PRIOR TO THE 3243 02:16:11,160 --> 02:16:12,080 SUCCESSES OF THE COVID-19 3244 02:16:12,080 --> 02:16:13,800 VACCINE AND THIS WAS ALSO STATED 3245 02:16:13,800 --> 02:16:18,040 VERY WELL BY MY COLLEAGUE, JOHN 3246 02:16:18,040 --> 02:16:19,680 WARREN AND THERE ARE TWO AWARDS 3247 02:16:19,680 --> 02:16:24,160 BY Dr. HAYNES AND Dr. 3248 02:16:24,160 --> 02:16:25,360 WEISSMAN AND THANK YOU TO ALL 3249 02:16:25,360 --> 02:16:27,120 OUR HIV SCIENTISTS AND ALL THE 3250 02:16:27,120 --> 02:16:28,680 MEMBERS WHO ALREADY HAVE THE 3251 02:16:28,680 --> 02:16:30,440 INTERNATIONAL AWARENESS AND 3252 02:16:30,440 --> 02:16:32,440 THESE INVESTIGATORS CAN 3253 02:16:32,440 --> 02:16:36,720 INFORMALLY ADVISE AND PROVIDE NO 3254 02:16:36,720 --> 02:16:39,280 HOW WITHOUT SHARING COMPANY 3255 02:16:39,280 --> 02:16:40,480 INTELLECTUAL PROPERTY WITH 3256 02:16:40,480 --> 02:16:44,560 ENTITIES SUCH AS AFRIGEN IN 3257 02:16:44,560 --> 02:16:47,520 SOUTH AFRICA AND IN THAILAND AND 3258 02:16:47,520 --> 02:16:50,800 THIS HAS BEEN STATED BY Dr. 3259 02:16:50,800 --> 02:16:54,600 FAUCI AND MY COLLEAGUE ANGELA. 3260 02:16:54,600 --> 02:16:58,520 FINALLY, A COUPLE OF IPCAVD 3261 02:16:58,520 --> 02:17:00,240 PROGRAMS DID NOT MAKE IT TO 3262 02:17:00,240 --> 02:17:05,280 MANUFACTURING DUE TO LACK OF 3263 02:17:05,280 --> 02:17:07,240 IMMUNOGEN OR EFFICACY BUT YOU 3264 02:17:07,240 --> 02:17:09,400 CAN SEE THE PROGRAM HAS BEEN 3265 02:17:09,400 --> 02:17:15,200 SUCCESSFUL AND VERY PRODUCTIVE. 3266 02:17:15,200 --> 02:17:16,680 I WOULD LIKE TO TOUCH UPON THE 3267 02:17:16,680 --> 02:17:17,960 SCOPE OF THE INITIATIVE. 3268 02:17:17,960 --> 02:17:21,760 ON THIS SLIDE, THE TEXT IN BOLD 3269 02:17:21,760 --> 02:17:24,480 SHOWS THOSE THAT ARE NEW TO THIS 3270 02:17:24,480 --> 02:17:30,800 PARTICULAR CONCEPT FORT FOR FISL 3271 02:17:30,800 --> 02:17:31,520 YEAR '24. 3272 02:17:31,520 --> 02:17:34,120 CONSIDERED WOULD BE SCOPE IS HIV 3273 02:17:34,120 --> 02:17:37,880 IMMUNOGEN DESIGNED TO IN 3274 02:17:37,880 --> 02:17:39,960 COMBINATION WITH INNATE OR 3275 02:17:39,960 --> 02:17:41,960 ADAPTIVE IMMUNE RESPONSE 3276 02:17:41,960 --> 02:17:44,400 STABILIZED HIV ENVELOPE PROTEIN 3277 02:17:44,400 --> 02:17:45,920 IMMUNOGENS DESIGNED TO MINIMIZE 3278 02:17:45,920 --> 02:17:48,360 RESPONSE OF OFF-TARGET 3279 02:17:48,360 --> 02:17:49,840 EPIDEMIOLOGI' TOPS AND PLATFORMS 3280 02:17:49,840 --> 02:17:51,480 AND ESPECIALLY PLATFORMS THAT 3281 02:17:51,480 --> 02:17:54,760 OFFER ADVANTAGES OF 3282 02:17:54,760 --> 02:17:56,000 DOSE-SPARRING OR ACCELERATED 3283 02:17:56,000 --> 02:17:57,040 MANUFACTURING PROCESSES. 3284 02:17:57,040 --> 02:18:00,200 PRE CLINICAL ANIMAL MODELS. 3285 02:18:00,200 --> 02:18:02,560 THE KNOCK-IN MICE EXPRESSING 3286 02:18:02,560 --> 02:18:08,200 HUMAN IMMUNO GLOBIN GENES FOR 3287 02:18:08,200 --> 02:18:11,400 BNABS BUT THIS TIME AROUND THE 3288 02:18:11,400 --> 02:18:14,920 NON HUMAN PRIMATES AND EFFICACY 3289 02:18:14,920 --> 02:18:16,360 OR CHALLENGE STUDIES ARE NOT 3290 02:18:16,360 --> 02:18:20,360 PRIOR TO AREA OF SUPPORT TO THE 3291 02:18:20,360 --> 02:18:22,160 IPCAVD AND IT'S PRESENTED IN A 3292 02:18:22,160 --> 02:18:23,720 LATER SLIDE. 3293 02:18:23,720 --> 02:18:24,840 THE APPLICANTS WOULD BE 3294 02:18:24,840 --> 02:18:26,760 ENCOURAGED TO SEEK FUNDING 3295 02:18:26,760 --> 02:18:28,640 THROUGH OTHER MECHANISMS THROUGH 3296 02:18:28,640 --> 02:18:30,680 EFFICACY STUDIES AND SUCH AS OUR 3297 02:18:30,680 --> 02:18:32,320 CONTRACT MECHANISM AND THE 3298 02:18:32,320 --> 02:18:34,480 VACCINE EVALUATION UNITS. 3299 02:18:34,480 --> 02:18:36,680 SO SOME OF THE NONRESPONSE I 3300 02:18:36,680 --> 02:18:38,160 HAVE AREAS THAT I WOULD LIKE TO 3301 02:18:38,160 --> 02:18:42,880 ADDRESS ARE BASED ON THE CURRENT 3302 02:18:42,880 --> 02:18:45,040 STATUS OF THE NIH AND THESE ARE 3303 02:18:45,040 --> 02:18:47,880 STUDIES WITH GP1 IMMUNOGENS 3304 02:18:47,880 --> 02:18:49,520 ALONE OR IN COMBINATION AND 3305 02:18:49,520 --> 02:18:51,680 DESIGNED TO YOU ILLICIT 3306 02:18:51,680 --> 02:18:54,120 PRIMARILY NON NEUTRALIZING 3307 02:18:54,120 --> 02:18:55,960 ANTIBODIES AND APPLICATIONS WITH 3308 02:18:55,960 --> 02:18:57,880 MANUFACTURE OF ADJUVANTS BECAUSE 3309 02:18:57,880 --> 02:18:59,960 YOU HAVE OTHER SOURCES OF 3310 02:18:59,960 --> 02:19:02,400 THROUGH WHICH PIs WOULD 3311 02:19:02,400 --> 02:19:04,200 MANUFACTURE THESE ADJUVANTS AND 3312 02:19:04,200 --> 02:19:05,480 DEVELOPMENT IN MANUFACTURE OF 3313 02:19:05,480 --> 02:19:10,920 THERAPEUTIC INTERVENTIONS. 3314 02:19:10,920 --> 02:19:13,040 AS I STATED EARLIER THE FUNDING 3315 02:19:13,040 --> 02:19:15,160 OF CLINICAL STUDIES WILL NOT BE 3316 02:19:15,160 --> 02:19:16,240 SUPPORTED, HOWEVER, THE 3317 02:19:16,240 --> 02:19:17,520 APPLICANTS WOULD BE REQUIRED TO 3318 02:19:17,520 --> 02:19:19,680 SUBMIT A CLINICAL DEVELOPMENT 3319 02:19:19,680 --> 02:19:21,480 PLAN DESCRIBING THE CLINICAL 3320 02:19:21,480 --> 02:19:22,760 STRATEGIES AND PRO TEN SHALL 3321 02:19:22,760 --> 02:19:26,120 PARTNERS FOR TESTING THE 3322 02:19:26,120 --> 02:19:27,200 HYPOTHESIS-DRIVEN PROOF OF 3323 02:19:27,200 --> 02:19:30,840 CONCEPT AND A LETTER OF SUPPORT 3324 02:19:30,840 --> 02:19:32,760 WOULD BE REQUIRED AND A PRODUCT 3325 02:19:32,760 --> 02:19:33,400 DEVELOPMENT PLAN WOULD BE 3326 02:19:33,400 --> 02:19:36,720 REQUIRED IN THE MANUFACTURING 3327 02:19:36,720 --> 02:19:37,760 PROJECT. 3328 02:19:37,760 --> 02:19:39,440 MILESTONE PLAN WITH NO CRITERIA 3329 02:19:39,440 --> 02:19:41,840 AND TIME LINES TO KEEP ON 3330 02:19:41,840 --> 02:19:44,080 SCHEDULE WOULD BE REQUIRED. 3331 02:19:44,080 --> 02:19:45,720 BASED ON EXPERIENCES OVER THE 3332 02:19:45,720 --> 02:19:48,440 YEARS, WITH MANY PROGRAMS, WE 3333 02:19:48,440 --> 02:19:51,320 HAVE ADDED THIS NEW PLAN WHICH 3334 02:19:51,320 --> 02:19:53,720 IS A PRODUCT STORAGE AND 3335 02:19:53,720 --> 02:19:54,720 STABILITY PROGRAM. 3336 02:19:54,720 --> 02:19:57,880 THIS WOULD BE BASICALLY TO HELP 3337 02:19:57,880 --> 02:19:59,520 GRANTEES BE THINKING AHEAD OF 3338 02:19:59,520 --> 02:20:01,320 HOW TO MANAGE THE INVENTORY THAT 3339 02:20:01,320 --> 02:20:03,360 IS GENERATED OUT OF THESE 3340 02:20:03,360 --> 02:20:05,200 PROGRAMS AND THE EXPECTATION IS 3341 02:20:05,200 --> 02:20:06,760 THE GROUND INSTITUTES WILL 3342 02:20:06,760 --> 02:20:07,920 ASSUME RESPONSIBILITY OF 3343 02:20:07,920 --> 02:20:09,800 SUPPORTING STORAGE AND STABILITY 3344 02:20:09,800 --> 02:20:11,480 PROGRAMS THAT FALL OUTSIDE THE 3345 02:20:11,480 --> 02:20:17,240 PROJECT PERIOD. 3346 02:20:17,240 --> 02:20:20,000 AS I MENTIONED EARLIER, THIS IS 3347 02:20:20,000 --> 02:20:21,880 A U19 WHICH IS A CO-OPERATIVE 3348 02:20:21,880 --> 02:20:23,080 AGREEMENT THAT REQUIRES 3349 02:20:23,080 --> 02:20:25,760 SIGNIFICANT OVERSIGHT BY 3350 02:20:25,760 --> 02:20:26,640 PROGRAMS. 3351 02:20:26,640 --> 02:20:27,760 AND AN EXTERNAL ADVISORY 3352 02:20:27,760 --> 02:20:29,200 COMMITTEE OF SCIENTIFIC EXPERTS 3353 02:20:29,200 --> 02:20:32,120 IS IDENTIFIED WITH PROGRAM 3354 02:20:32,120 --> 02:20:32,440 CONCURRENCE. 3355 02:20:32,440 --> 02:20:35,560 BECAUSE THE APPLICANT PROVIDES 3356 02:20:35,560 --> 02:20:38,160 PRE DETERMINED IMMUNO LOGICAL 3357 02:20:38,160 --> 02:20:40,840 MANUFACTURING GO-NO-GO CRITERIA 3358 02:20:40,840 --> 02:20:44,400 IT ALLOWS MONITORING BUDGET FOR 3359 02:20:44,400 --> 02:20:46,080 CGMP MANUFACTURING THAT COULD BE 3360 02:20:46,080 --> 02:20:47,240 LIMITED IF THE MILESTONES ARE 3361 02:20:47,240 --> 02:20:47,960 NOT MET. 3362 02:20:47,960 --> 02:20:50,560 AND PROGRAM ASSESS READINESS FOR 3363 02:20:50,560 --> 02:20:53,360 GNP MANUFACTURING AT THE END OF 3364 02:20:53,360 --> 02:20:54,200 YEAR 2 TO NISH MANUFACTURING IN 3365 02:20:54,200 --> 02:20:54,800 YEAR THREE. 3366 02:20:54,800 --> 02:20:57,000 WE WANT TO SEE THIS AS A SLIGHT 3367 02:20:57,000 --> 02:20:58,200 ACCELERATION BECAUSE WE WILL 3368 02:20:58,200 --> 02:21:00,560 MONITOR IT AND HOPE THAT THE 3369 02:21:00,560 --> 02:21:01,520 MANUFACTURING CAN BEGIN EARLIER 3370 02:21:01,520 --> 02:21:04,360 IN THE YEAR OF THREE RATHER THAN 3371 02:21:04,360 --> 02:21:07,640 LATE YEAR THREE. 3372 02:21:07,640 --> 02:21:15,240 SO I'D LIKE TO REVIEWERS -- I'D 3373 02:21:15,240 --> 02:21:18,280 LIKE TO THANK OUR REVIEWERS TO 3374 02:21:18,280 --> 02:21:20,480 MAKE THIS PROBABLY A BETTER 3375 02:21:20,480 --> 02:21:20,880 PRESENTATION. 3376 02:21:20,880 --> 02:21:22,480 BOTH REVIEWERS EXPRESSED SUPPORT 3377 02:21:22,480 --> 02:21:24,440 FOR THIS PROGRAM AS PROPOSED. 3378 02:21:24,440 --> 02:21:26,360 AND I'D LIKE TO QUOTE FROM ONE 3379 02:21:26,360 --> 02:21:28,720 OF THE REVIEWERS, THIS IS AN 3380 02:21:28,720 --> 02:21:30,400 IMPORTANT PROGRAM WITH A LOT OF 3381 02:21:30,400 --> 02:21:31,480 SUCCESSES WITH INTERESTING 3382 02:21:31,480 --> 02:21:33,600 PRODUCTS MOVING FORWARD. 3383 02:21:33,600 --> 02:21:35,200 DEVELOPING A VACCINE IS AN 3384 02:21:35,200 --> 02:21:36,880 ENORMOUS CHALLENGE CAN YOU CAN 3385 02:21:36,880 --> 02:21:38,560 POINT TO A LOT OF UNIQUE 3386 02:21:38,560 --> 02:21:40,120 EXPERIMENTAL APPROACHES FROM THE 3387 02:21:40,120 --> 02:21:40,480 PROGRAM. 3388 02:21:40,480 --> 02:21:42,160 THIS PROGRAM IS VITAL AND AMONG 3389 02:21:42,160 --> 02:21:43,320 OUR BEST HOPES OF HAVING 3390 02:21:43,320 --> 02:21:44,120 SOMETHING THAT COULD DEVELOP 3391 02:21:44,120 --> 02:21:47,080 INTO AN EFFECTIVE HIV VACCINE. 3392 02:21:47,080 --> 02:21:48,480 AND WE COULDN'T HAVE SAID IT 3393 02:21:48,480 --> 02:21:50,400 BETTER AND WE TOTALLY, THIS IS 3394 02:21:50,400 --> 02:21:51,960 HOW WE FEEL ABOUT THIS PROGRAM 3395 02:21:51,960 --> 02:21:54,600 AND THANK YOU FOR THE OPTIMISM. 3396 02:21:54,600 --> 02:21:56,040 ONE OF THE REVIEWERS EMPHASIZED 3397 02:21:56,040 --> 02:21:57,680 THAT THE CLINICAL TRIAL TIMELINE 3398 02:21:57,680 --> 02:22:02,480 AND FUNDING IS SEPARATE FROM THE 3399 02:22:02,480 --> 02:22:03,720 IPCVED AND IT SHOULD BE NOTED 3400 02:22:03,720 --> 02:22:06,560 AND WE BELIEVE WE HAVE ADDRESSED 3401 02:22:06,560 --> 02:22:09,600 IT IN THE PRESENTATION. 3402 02:22:09,600 --> 02:22:13,200 THERE SEEMS TO BE A BIG EMPHASIS 3403 02:22:13,200 --> 02:22:14,360 ON THE MANUFACTURING AND HOW 3404 02:22:14,360 --> 02:22:16,160 MATURE IS THE CONCEPT AT THE 3405 02:22:16,160 --> 02:22:17,200 TIME THE PRODUCTS ARE PRODUCED 3406 02:22:17,200 --> 02:22:19,440 FOR CLINICAL STUDIES. 3407 02:22:19,440 --> 02:22:22,200 BASICALLY THE SUPPORT ADVANCED 3408 02:22:22,200 --> 02:22:23,000 IMMUNOGENS BEYOND BASIC 3409 02:22:23,000 --> 02:22:24,240 DISCOVERY AND FURTHER ALONG IN 3410 02:22:24,240 --> 02:22:26,520 RESEARCH AND DEVELOPMENT AND 3411 02:22:26,520 --> 02:22:28,280 CONCEPTS SHOULD INCLUDE WELL 3412 02:22:28,280 --> 02:22:29,040 CHARACTERIZED PRODUCT AND 3413 02:22:29,040 --> 02:22:32,680 PROCESS THAT'S CAN GENERATE 3414 02:22:32,680 --> 02:22:33,640 DESIGN RAT TRA BEAUT SCALE FOR 3415 02:22:33,640 --> 02:22:34,680 MANUFACTURING WHAT IS THE REASON 3416 02:22:34,680 --> 02:22:36,680 TO LIMIT THE STUDIES AND THIS IS 3417 02:22:36,680 --> 02:22:38,520 WHAT I ALLUDED TO EARLIER. 3418 02:22:38,520 --> 02:22:40,880 SO THERE ARE OTHER FUNDING 3419 02:22:40,880 --> 02:22:42,160 MECHANISMS IN DAIDS TO SUPPORT 3420 02:22:42,160 --> 02:22:44,680 EFFICACY STUDIES IN ENERGY AND 3421 02:22:44,680 --> 02:22:46,360 CHALLENGE STUDIES CAN TAKE 18 3422 02:22:46,360 --> 02:22:47,360 MONTHS TO TWO YEARS AND NEED TO 3423 02:22:47,360 --> 02:22:49,840 BE REPEATED FOR REPRODUCIBILITY. 3424 02:22:49,840 --> 02:22:51,360 EFFICACY STUDIES ARE NOT 3425 02:22:51,360 --> 02:22:52,800 INCLUDED DUE TO THE NEED TO 3426 02:22:52,800 --> 02:22:54,480 ACCELERATE MANUFACTURING TIME 3427 02:22:54,480 --> 02:22:55,280 LINES. 3428 02:22:55,280 --> 02:22:57,440 FURTHERMORE, RESULTS FROM THE 3429 02:22:57,440 --> 02:22:58,760 NHP STUDY DID NOT TRANSLATE INTO 3430 02:22:58,760 --> 02:23:02,880 THE CLINIC FOR HVTN705 AND THE 3431 02:23:02,880 --> 02:23:06,240 USER OF KNOCK-IN MICE EXPRESSING 3432 02:23:06,240 --> 02:23:07,440 HUMAN ANTIBODIES GENES HAVE 3433 02:23:07,440 --> 02:23:08,960 SUPPORTED TRANSLATION OF 3434 02:23:08,960 --> 02:23:10,880 CONCEPTS, WITH AN IMMUNOGEN THAT 3435 02:23:10,880 --> 02:23:13,920 TARGETS CD4 BINDING CITE 3436 02:23:13,920 --> 02:23:15,920 LINEAGES INTO THE CLINIC AND SO 3437 02:23:15,920 --> 02:23:18,400 WE NEED TO STRIKE A BALANCE 3438 02:23:18,400 --> 02:23:23,480 BETWEEN THESE TYPE OF STUDIES. 3439 02:23:23,480 --> 02:23:26,600 IS IT S THERE AN OBLIGATION FOR 3440 02:23:26,600 --> 02:23:27,920 CLINICAL TRIALS THAT HAVE 3441 02:23:27,920 --> 02:23:29,000 ADVANCED WITH THIS PROGRAM? 3442 02:23:29,000 --> 02:23:30,560 9 APPLICANTS ARE REQUIRED TO 3443 02:23:30,560 --> 02:23:32,160 INCLUDE A DEVELOPMENT PLAN IN 3444 02:23:32,160 --> 02:23:33,000 THE APPLICATION. 3445 02:23:33,000 --> 02:23:36,320 THEY MUST IDENTIFY POTENTIAL 3446 02:23:36,320 --> 02:23:37,480 CLINICAL PARTNERS, IT DOESN'T 3447 02:23:37,480 --> 02:23:39,760 HAVE TO BE A NETWORK PARTNER. 3448 02:23:39,760 --> 02:23:41,400 THERE'S NO OBLIGATION FOR THE 3449 02:23:41,400 --> 02:23:45,760 GRANTEE TO USE THE HVTN TO 3450 02:23:45,760 --> 02:23:47,640 CONDUCT THE TRIAL AND WHAT KIND 3451 02:23:47,640 --> 02:23:50,120 OF TRY TERRIA TARGET NEEDS TO BE 3452 02:23:50,120 --> 02:23:51,640 MET BY THE PRODUCT TO BE A 3453 02:23:51,640 --> 02:23:53,440 VIABLE CANDIDATE FOR THIS 3454 02:23:53,440 --> 02:23:54,520 FUNDING MECHANISM? 3455 02:23:54,520 --> 02:23:56,760 IT DOES NOT SPECIFY OR PROVIDE A 3456 02:23:56,760 --> 02:23:58,640 CUSTOMIZED LIST OF TARGET 3457 02:23:58,640 --> 02:23:59,560 ATTRIBUTES OF TARGETS BECAUSE 3458 02:23:59,560 --> 02:24:04,760 THE GOAL OF THE IPCAVD IS TO 3459 02:24:04,760 --> 02:24:06,560 SUPPORT INNOVATIVE PROOF OF 3460 02:24:06,560 --> 02:24:09,240 CONCEPTS FOR MANUFACTURING HIV 3461 02:24:09,240 --> 02:24:12,760 CANDIDATES FOR CLINICAL TESTING. 3462 02:24:12,760 --> 02:24:15,280 THIS BRINGS ME BACK TO THE SLIDE 3463 02:24:15,280 --> 02:24:16,560 WHERE I REQUEST COUNCIL FOR 3464 02:24:16,560 --> 02:24:19,880 APPROVAL OF REISSUE OF THIS 3465 02:24:19,880 --> 02:24:20,800 LONGSTANDING WE BELIEVE 3466 02:24:20,800 --> 02:24:21,640 PRODUCTIVE PROGRAM AND THANK YOU 3467 02:24:21,640 --> 02:24:24,760 FOR YOUR ATTENTION. 3468 02:24:24,760 --> 02:24:28,960 >> THANK YOU, VERY MUCH. 3469 02:24:28,960 --> 02:24:30,160 VERY INTERESTING AND THANK YOU 3470 02:24:30,160 --> 02:24:32,520 FOR SHARING THE HISTORY OF THE 3471 02:24:32,520 --> 02:24:34,080 MANY SUCCESSES THAT HAVE COME 3472 02:24:34,080 --> 02:24:37,480 THROUGH THIS PROGRAM TO DATE. 3473 02:24:37,480 --> 02:24:39,000 LET ME ASK EVERYONE TO REOPEN 3474 02:24:39,000 --> 02:24:43,920 THEIR ECBs AND TO VOTE ON THIS 3475 02:24:43,920 --> 02:24:45,600 CONCEPT AND HAPPY TO TAKE 3476 02:24:45,600 --> 02:24:49,200 ADDITIONAL QUESTIONS THAT PEOPLE 3477 02:24:49,200 --> 02:24:58,600 MAY HAVE. 3478 02:24:58,600 --> 02:25:02,160 I UNDERSTAND THE RESISTANCE TO 3479 02:25:02,160 --> 02:25:06,200 HAVING NHP CHARGE STUDIES BUT, I 3480 02:25:06,200 --> 02:25:08,080 GUESS THAT INFORMATION IS NEEDED 3481 02:25:08,080 --> 02:25:10,280 A LOT OF TIMES BEFORE THIS WILL 3482 02:25:10,280 --> 02:25:13,000 GO INTO A CLINICAL STUDY, IS 3483 02:25:13,000 --> 02:25:16,640 THAT CORRECT OR NOT CORRECT? 3484 02:25:16,640 --> 02:25:26,720 >> WE HAVE EXAMPLES OF IT BEING 3485 02:25:26,720 --> 02:25:27,880 TRANSLATED IN SOME STUDIES AND 3486 02:25:27,880 --> 02:25:29,440 SOME STUDIES THEY'RE NOT 3487 02:25:29,440 --> 02:25:31,320 TRANSLATED SO WE NEED TO STRIKE 3488 02:25:31,320 --> 02:25:31,840 A BALANCE. 3489 02:25:31,840 --> 02:25:37,720 I MEAN, I CAN SENSE THAT FOR IT 3490 02:25:37,720 --> 02:25:40,400 IS DEFINITELY HELPFUL TO HAVE AN 3491 02:25:40,400 --> 02:25:42,640 STUDY THAT CAN BE REPEATED AND 3492 02:25:42,640 --> 02:25:44,000 THEN TAKE THE PRODUCT TO THE 3493 02:25:44,000 --> 02:25:44,360 CLINIC. 3494 02:25:44,360 --> 02:25:48,800 BUT THAT WOULD BE REALLY LONG 3495 02:25:48,800 --> 02:25:49,040 PROGRAM. 3496 02:25:49,040 --> 02:25:52,600 >> AND THEN A RELATED QUESTION, 3497 02:25:52,600 --> 02:25:54,400 SOMETIMES WE'VE HAD HISTORICALLY 3498 02:25:54,400 --> 02:25:57,560 REAL DIFFICULTIES IN 3499 02:25:57,560 --> 02:25:58,880 MANUFACTURING PRODUCTS AND THIS, 3500 02:25:58,880 --> 02:26:01,280 I GUESS IT'S RELATED TO WHY YOU 3501 02:26:01,280 --> 02:26:03,720 DON'T WANT THESE NHP CHALLENGE 3502 02:26:03,720 --> 02:26:05,200 STUDIES BUT I ASSUME, HAVE YOU 3503 02:26:05,200 --> 02:26:07,400 HAD TO WORK IN PREVIOUSLY WITH 3504 02:26:07,400 --> 02:26:09,360 THESE GROUPS WHERE THE 3505 02:26:09,360 --> 02:26:11,200 MANUFACTURE DIDN'T GO QUITE AS 3506 02:26:11,200 --> 02:26:11,680 PLANNED? 3507 02:26:11,680 --> 02:26:14,960 AND IS THERE FLEXIBILITY THERE? 3508 02:26:14,960 --> 02:26:16,400 >> FLEXIBILITY FOR WHAT? 3509 02:26:16,400 --> 02:26:19,600 >> WELL, IF THEY NEED MORE TIME 3510 02:26:19,600 --> 02:26:21,120 OR AN EXTENSION, THAT WOULD GO 3511 02:26:21,120 --> 02:26:22,080 BACK TO THIS COUNCIL OR 3512 02:26:22,080 --> 02:26:24,240 SOMETHING LIKE THAT? 3513 02:26:24,240 --> 02:26:26,800 >> I MEAN, IT DOES TAKE A LONG 3514 02:26:26,800 --> 02:26:28,440 TIME FOR THESE PROGRAMS TO COME 3515 02:26:28,440 --> 02:26:30,160 THROUGH, ESPECIALLY FOR BUY 3516 02:26:30,160 --> 02:26:31,280 LOGICS AND PROTEINS. 3517 02:26:31,280 --> 02:26:33,440 THE mRNA AND DNAs ARE A 3518 02:26:33,440 --> 02:26:36,120 LITTLE BIT FASTER BUT THEN EVEN 3519 02:26:36,120 --> 02:26:37,920 GIVEN THE WAY WE FUNCTION 3520 02:26:37,920 --> 02:26:40,520 THROUGH A GOVERNMENT GRANT 3521 02:26:40,520 --> 02:26:42,320 MECHANISM, THERE ARE SO MANY 3522 02:26:42,320 --> 02:26:43,480 ISSUES THAT COULD CHARGES THAT 3523 02:26:43,480 --> 02:26:46,400 WOULD COME UP, FOR EXAMPLE, THE 3524 02:26:46,400 --> 02:26:47,600 INSTITUTIONS AND THEY COULD BE 3525 02:26:47,600 --> 02:26:48,880 SOME LEGAL IMPLICATIONS WHEN 3526 02:26:48,880 --> 02:26:50,720 THEY ARE TRYING TO NEGOTIATE 3527 02:26:50,720 --> 02:26:53,560 CONTRACTS TO BE AGREEMENTS WITH 3528 02:26:53,560 --> 02:26:55,080 MANUFACTURERS AND THEN IT'S FOR 3529 02:26:55,080 --> 02:26:57,240 EXAMPLE THE COVID PANDEMIC 3530 02:26:57,240 --> 02:26:58,760 CREATED A TIGHT SUPPLY CHAIN 3531 02:26:58,760 --> 02:27:01,440 ISSUE AND THERE WAS LACK OF 3532 02:27:01,440 --> 02:27:03,040 MATERIALS THAT WAS NEEDED SO ALL 3533 02:27:03,040 --> 02:27:06,240 OF THESE CAN ADD DELAYS TO THE 3534 02:27:06,240 --> 02:27:08,240 PROGRAM SO THEY END UPTAKING A 3535 02:27:08,240 --> 02:27:11,720 WHILE AND I MEAN THEY DO GO INTO 3536 02:27:11,720 --> 02:27:14,240 NO COST EXTENSIONS SO OUR 3537 02:27:14,240 --> 02:27:16,160 ATTEMPT AT THIS FUNDING OPTION 3538 02:27:16,160 --> 02:27:18,440 ANNOUNCEMENT ROUND IS TO TRY TO 3539 02:27:18,440 --> 02:27:20,960 KIND OF SHORTEN THE TIMELINE SO 3540 02:27:20,960 --> 02:27:22,800 WE DON'T GO INTO SEVEN YEARS OF 3541 02:27:22,800 --> 02:27:24,720 PROGRAMS AND YES, THERE ARE 3542 02:27:24,720 --> 02:27:26,280 ISSUES OF MANUFACTURING THAT ARE 3543 02:27:26,280 --> 02:27:27,960 A COUPLE OF PROGRAMS THAT DID 3544 02:27:27,960 --> 02:27:29,400 NOT MAKE IT INTO THE 3545 02:27:29,400 --> 02:27:31,560 MANUFACTURING ITSELF AND YOU 3546 02:27:31,560 --> 02:27:33,840 KNOW, SOME OF THEM HAVE ENDED 3547 02:27:33,840 --> 02:27:35,040 EARLIER BECAUSE THE GROUND ENDED 3548 02:27:35,040 --> 02:27:37,880 BUT WE COULDN'T FINISH GMP 3549 02:27:37,880 --> 02:27:39,080 BECAUSE THE PRODUCT DID NOT GET 3550 02:27:39,080 --> 02:27:41,240 TO THE AMOUNT THAT WE WANTED TO 3551 02:27:41,240 --> 02:27:43,120 THE PURITY AS WELL AS THE 3552 02:27:43,120 --> 02:27:44,280 QUALITY OR WE COULDN'T GET 3553 02:27:44,280 --> 02:27:47,000 ENOUGH MATERIALS FOR THE CLINIC. 3554 02:27:47,000 --> 02:27:49,360 SO WHY WANT TO NAME SPECIFIC 3555 02:27:49,360 --> 02:27:50,360 PROGRAMS, BUT, YES, THERE ARE 3556 02:27:50,360 --> 02:27:51,640 ALL SORTS OF SITUATIONS AND 3557 02:27:51,640 --> 02:27:53,760 THERE'S NO ONE SPECIFIC PROGRAM 3558 02:27:53,760 --> 02:27:56,480 THAT IS LIKE THE OTHER. 3559 02:27:56,480 --> 02:28:00,720 >> THANK YOU. 3560 02:28:00,720 --> 02:28:03,240 Dr. DEIN. 3561 02:28:03,240 --> 02:28:09,840 DIEFFENBACH.>> WE HAVE A PRO BUM 3562 02:28:09,840 --> 02:28:13,480 FOR PRIME AT REEVALUATION. 3563 02:28:13,480 --> 02:28:14,880 THERE ARE WAYS TO GET DOWN 3564 02:28:14,880 --> 02:28:16,200 WITHOUT BEING PART OF THIS GRANT 3565 02:28:16,200 --> 02:28:17,920 AND THAT'S THE POINT, WE HAVE 3566 02:28:17,920 --> 02:28:18,240 FLEXIBILITY. 3567 02:28:18,240 --> 02:28:21,080 THIS IS FOCUSED ON MANUFACTURE 3568 02:28:21,080 --> 02:28:25,800 AND GETTING TOWARDS CLINIC AND 3569 02:28:25,800 --> 02:28:27,080 THE IT COULD BE ELSEWHERE. 3570 02:28:27,080 --> 02:28:31,520 >> THANK YOU. 3571 02:28:31,520 --> 02:28:32,640 OTHER QUESTIONS OR THOUGHTS THAT 3572 02:28:32,640 --> 02:28:38,040 PEOPLE HAVE, PLEASE, VOTE. 3573 02:28:38,040 --> 02:28:41,840 VOTE EARLY AND OFTEN HERE. 3574 02:28:41,840 --> 02:28:49,800 >> THANK YOU, Dr. DIEFFENBACH 3575 02:28:49,800 --> 02:28:50,880 AND COUNCIL. 3576 02:28:50,880 --> 02:28:53,120 OUR LAST CONCEPT WE'RE SWITCHING 3577 02:28:53,120 --> 02:28:59,560 FROM THE VACCINE PROGRAM TO A 3578 02:28:59,560 --> 02:29:00,520 NEW INITIATIVE. 3579 02:29:00,520 --> 02:29:02,760 THE NIH MEDICAL SCIENTIST 3580 02:29:02,760 --> 02:29:03,720 PARTNERSHIP PROGRAM WILL BE 3581 02:29:03,720 --> 02:29:06,440 PRESENTED BY Dr. MATTHEW 3582 02:29:06,440 --> 02:29:06,680 FENTON. 3583 02:29:06,680 --> 02:29:08,320 >> GREAT. 3584 02:29:08,320 --> 02:29:08,640 THANK YOU. 3585 02:29:08,640 --> 02:29:10,800 AND I WANT TO THANK THE 3586 02:29:10,800 --> 02:29:12,920 COMMITTEE FOR THE TIME TODAY TO 3587 02:29:12,920 --> 02:29:16,000 PRESENT THIS BRAND NEW TRANS NIH 3588 02:29:16,000 --> 02:29:17,560 INITIATIVE THAT WE'RE CALLING 3589 02:29:17,560 --> 02:29:20,280 THE NIH MEDICAL SCIENTIST 3590 02:29:20,280 --> 02:29:25,120 PARTNERSHIP PROGRAM OR MSPP. 3591 02:29:25,120 --> 02:29:28,480 SO IT'S BEEN LONG RECOGNIZED IN 3592 02:29:28,480 --> 02:29:30,520 ACADEMIA AND BY NIH THAT WE 3593 02:29:30,520 --> 02:29:33,840 REALLY NEED TO HAVE CONCERTED 3594 02:29:33,840 --> 02:29:36,040 EFFORT TO GROW THE HIGHLY 3595 02:29:36,040 --> 02:29:37,360 VALUABLE PHYSICIAN SCIENTIST 3596 02:29:37,360 --> 02:29:39,200 PIPELINE THAT THIS IS A GREAT OF 3597 02:29:39,200 --> 02:29:41,200 SCIENTISTS THAT REALLY NEED 3598 02:29:41,200 --> 02:29:44,120 EXTRA SUPPORT AND EXTRA 3599 02:29:44,120 --> 02:29:45,560 OPPORTUNITIES FOR WHICH TO ENTER 3600 02:29:45,560 --> 02:29:50,920 THE BIOMEDICAL WORKFORCE. 3601 02:29:50,920 --> 02:29:54,480 AND THERE ARE ALREADY SEVERAL 3602 02:29:54,480 --> 02:29:56,360 EXISTING WELL-SUPPORTED AND 3603 02:29:56,360 --> 02:29:58,080 HIGHLY FUNCTIONAL PROGRAMS AT 3604 02:29:58,080 --> 02:30:00,320 NIH THAT SUPPORT PHYSICIAN 3605 02:30:00,320 --> 02:30:02,800 SCIENTISTS BUT THERE'S ALSO THE 3606 02:30:02,800 --> 02:30:04,360 OPPORTUNITY TO HE CAN PANNED THE 3607 02:30:04,360 --> 02:30:07,680 KIND OF SUPPORT THAT NIH CAN 3608 02:30:07,680 --> 02:30:09,120 PROVIDE WE ARE SUPPORT 3609 02:30:09,120 --> 02:30:10,280 PHYSICIANS SCIENTISTS AND 3610 02:30:10,280 --> 02:30:12,040 TRAINING THROUGH THE MEDICAL 3611 02:30:12,040 --> 02:30:14,920 SCIENTISTS TRAINING PROGRAM OR 3612 02:30:14,920 --> 02:30:17,640 NSTP AND THIS IS A T32 BASED 3613 02:30:17,640 --> 02:30:21,120 PROGRAM THAT IS LED BY NIGMS AND 3614 02:30:21,120 --> 02:30:24,080 THERE'S THE RELATIVELY NEW STARS 3615 02:30:24,080 --> 02:30:25,200 AND STARTS PROGRAM WHICH SAY 3616 02:30:25,200 --> 02:30:28,640 RESEARCH AND RESIDENCY PROGRAM 3617 02:30:28,640 --> 02:30:32,440 AND NIAID IT'S SEV ITSELF HAS AN 3618 02:30:32,440 --> 02:30:34,920 SCIENTIST PATHWAY TO 3619 02:30:34,920 --> 02:30:40,480 INDEPENDENCE AWARD AUGUS A USIND 3620 02:30:40,480 --> 02:30:43,120 R00 AND THE F30 COMBINED DEGREE 3621 02:30:43,120 --> 02:30:45,560 NRSA FELLOWSHIP. 3622 02:30:45,560 --> 02:30:49,400 NOW, SINCE AROUND 2006, OVER 300 3623 02:30:49,400 --> 02:30:50,440 COMBINED DEGREES STUDENTS 3624 02:30:50,440 --> 02:30:52,760 LARGELY IN PARTNERSHIP WITH THE 3625 02:30:52,760 --> 02:30:54,880 MSTP UNIVERSITIES, HAVE PERSUADE 3626 02:30:54,880 --> 02:30:57,560 THEIR PHD DISSERTATION RESEARCH 3627 02:30:57,560 --> 02:30:59,880 IN NIH INTRAMURAL LABORATORIES 3628 02:30:59,880 --> 02:31:02,120 AND THEY'VE GONE ON TO 3629 02:31:02,120 --> 02:31:03,320 SUCCESSFUL CAREERS IN BIOMEDICAL 3630 02:31:03,320 --> 02:31:05,640 AND CLINICAL RESEARCH. 3631 02:31:05,640 --> 02:31:09,160 SO, WE FELT THERE WAS AN 3632 02:31:09,160 --> 02:31:12,080 OPPORTUNITY TO EXPAND THIS NIH 3633 02:31:12,080 --> 02:31:16,040 SUPPORT BEYOND JUST THE 53MSTP 3634 02:31:16,040 --> 02:31:19,880 UNIVERSITIES TO INCLUDE 3635 02:31:19,880 --> 02:31:24,640 ADDITIONAL MEDICAL DENTAL AND 3636 02:31:24,640 --> 02:31:25,600 VET SCHOOLS IN THE U.S. 3637 02:31:25,600 --> 02:31:28,440 THE MSPP IS DESIGNED TO PROVIDE 3638 02:31:28,440 --> 02:31:34,320 A PATHWAY TO ATTRACT TRAINEES 3639 02:31:34,320 --> 02:31:35,720 WHO ARE WOMEN AND UNDER 3640 02:31:35,720 --> 02:31:42,240 REPRESENTED MINORITIES. 3641 02:31:42,240 --> 02:31:44,440 THIS STUDENTS WISHING TO DO 3642 02:31:44,440 --> 02:31:46,560 THEIR DISSERTATION RESEARCH IN A 3643 02:31:46,560 --> 02:31:47,560 INTRAMURAL LABORATORY AND THE 3644 02:31:47,560 --> 02:31:49,600 GOAL IS TO BUILD A PIPELINE OF 3645 02:31:49,600 --> 02:31:52,440 TALENT FOR NOT ONLY THE IRP 3646 02:31:52,440 --> 02:31:54,320 ITSELF BUT LATER FOR THE 3647 02:31:54,320 --> 02:31:56,360 BIOMEDICAL WORKFORCE AS A WHOLE. 3648 02:31:56,360 --> 02:31:59,040 AND THE MSPP WILL ACCEPT 3649 02:31:59,040 --> 02:31:59,960 APPLICATIONS FROM STUDENTS WHO 3650 02:31:59,960 --> 02:32:01,960 WILL BE ATTENDING SCHOOLS AND 3651 02:32:01,960 --> 02:32:04,320 THAT BOTH DO AND DO NOT HAVE 3652 02:32:04,320 --> 02:32:06,000 EXISTING COMBINED DEGREE 3653 02:32:06,000 --> 02:32:06,320 PROGRAMS. 3654 02:32:06,320 --> 02:32:08,200 AND THAT MAKES IT QUITE DISTINCT 3655 02:32:08,200 --> 02:32:11,480 FROM THE OLDER MSTP PROGRAM. 3656 02:32:11,480 --> 02:32:12,640 AND WE ANTICIPATE THAT THE 3657 02:32:12,640 --> 02:32:14,520 PROGRAM WILL OPEN UP BROAD 3658 02:32:14,520 --> 02:32:16,120 POTENTIAL SOURCE OF COMBINED 3659 02:32:16,120 --> 02:32:18,000 DEGREES STUDENTS AND INCLUDING 3660 02:32:18,000 --> 02:32:24,240 THOSE ATTENDING HBCUs AND 3661 02:32:24,240 --> 02:32:26,200 MSIs. 3662 02:32:26,200 --> 02:32:27,280 THE NIAID WILL BE THE NATIONAL 3663 02:32:27,280 --> 02:32:29,160 LEAD INSTITUTE AND COORDINATE 3664 02:32:29,160 --> 02:32:31,080 WITH THE OTHER PARTICIPATING 3665 02:32:31,080 --> 02:32:35,200 INSTITUTES AND WE EXPECT THEY'LL 3666 02:32:35,200 --> 02:32:38,000 BE BETWEEN 12 AND 16 ADDITIONAL 3667 02:32:38,000 --> 02:32:39,400 ICs THAT WILL JOIN ON TO THIS 3668 02:32:39,400 --> 02:32:39,680 PROGRAM. 3669 02:32:39,680 --> 02:32:41,760 THE MSPP WILL USE A COMPLETELY 3670 02:32:41,760 --> 02:32:43,640 NEW FELLOWSHIP GRANT MECHANISM 3671 02:32:43,640 --> 02:32:45,920 CALLED THE FM1 GRANT. 3672 02:32:45,920 --> 02:32:48,440 THAT IT'S BASED ON INDIVIDUAL 3673 02:32:48,440 --> 02:32:51,880 RATHER THAN INSTITUTIONAL 3674 02:32:51,880 --> 02:32:54,120 CRITERIA LIKE THE T32 AND THE 3675 02:32:54,120 --> 02:32:55,320 MSTP PROGRAM. 3676 02:32:55,320 --> 02:32:57,120 THE INITIATIVE WILL HAVE A 3677 02:32:57,120 --> 02:32:58,920 SINGLE ANNUAL RECEIPT DATE IN 3678 02:32:58,920 --> 02:33:01,200 AUGUST AND IT WILL ACCOMMODATE 3679 02:33:01,200 --> 02:33:03,240 TWO TRACKS DEPENDING ON WHETHER 3680 02:33:03,240 --> 02:33:06,840 THE STUDENT OR POSTBAC APPLIES 3681 02:33:06,840 --> 02:33:08,680 BEFORE OR AFTER ACCEPTANCE TO 3682 02:33:08,680 --> 02:33:12,520 MEDICAL, DENTAL OR VETERINARY 3683 02:33:12,520 --> 02:33:12,880 SCHOOL. 3684 02:33:12,880 --> 02:33:14,920 UNDER GRADS AND POST PACKS WILL 3685 02:33:14,920 --> 02:33:17,920 APPLY USING NIAID AS THE 3686 02:33:17,920 --> 02:33:18,720 APPLICANT ORGANIZATION SAUL 3687 02:33:18,720 --> 02:33:22,160 THOUGH THE AWARD WILL BE MADE BY 3688 02:33:22,160 --> 02:33:24,200 THE STUDENTS' RESEARCH INSTITUTE 3689 02:33:24,200 --> 02:33:27,480 OR CENTER EXTRAMURAL DIVISION TO 3690 02:33:27,480 --> 02:33:30,200 THE STUDENTS MEDICAL, DENTAL OR 3691 02:33:30,200 --> 02:33:31,840 VETERINARY SCHOOL AND WE'RE 3692 02:33:31,840 --> 02:33:34,000 NEGOTIATING WITH CSR NOW TO 3693 02:33:34,000 --> 02:33:36,920 REVIEW THE APPLICATIONS AND 3694 02:33:36,920 --> 02:33:39,480 SPECIAL EMPHASIS PANEL. 3695 02:33:39,480 --> 02:33:40,840 NEXT SLIDE. 3696 02:33:40,840 --> 02:33:44,080 SO, THIS IS IT A TIMELINE AND 3697 02:33:44,080 --> 02:33:45,680 MAP FOR THE TWO TRACKS. 3698 02:33:45,680 --> 02:33:47,080 TRACK ONE WHERE THE STUDENTS 3699 02:33:47,080 --> 02:33:49,520 WILL GET THE AWARD AS THEY'RE 3700 02:33:49,520 --> 02:33:51,520 GETTING READY TO ENTER THEIR 3701 02:33:51,520 --> 02:33:52,840 CLINICAL DEGREE SCHOOLS WHEN 3702 02:33:52,840 --> 02:33:55,120 THEY MATRICULATE AND TRACK TWO 3703 02:33:55,120 --> 02:33:58,640 IS ESSENTIALLY A NEAR LATER AS 3704 02:33:58,640 --> 02:34:00,160 THE STUDENTS THEY GET THE AWARD 3705 02:34:00,160 --> 02:34:01,960 AS THEY'RE BEGINNING THEIR 3706 02:34:01,960 --> 02:34:04,120 SECOND YEAR IN MEDICAL, DENTAL 3707 02:34:04,120 --> 02:34:05,400 OR VET SCHOOL. 3708 02:34:05,400 --> 02:34:07,560 AND WHEN THEY'VE COMPLETED THE 3709 02:34:07,560 --> 02:34:08,520 FIRST TWO YEARS, THEN THE 3710 02:34:08,520 --> 02:34:10,640 STUDENT TAKES A LEAVE OF ABSENCE 3711 02:34:10,640 --> 02:34:12,520 AND THEY PHYSICALLY MOVE TO 3712 02:34:12,520 --> 02:34:19,080 TRACTOR-TRATOTHE TRAIN MURAL WHY 3713 02:34:19,080 --> 02:34:20,520 FOUR-YEAR PERIOD AND AT THAT 3714 02:34:20,520 --> 02:34:25,000 POINT THE MSPP GRANT IS ON HOLD. 3715 02:34:25,000 --> 02:34:26,240 AND THEN THEY'RE GETTING READY 3716 02:34:26,240 --> 02:34:28,280 TO START THE THIRD YEAR OF THEIR 3717 02:34:28,280 --> 02:34:30,920 CLINICAL TRAINING, THE INSTITUTE 3718 02:34:30,920 --> 02:34:33,600 THEN WILL AWARD AN EXTENSION, A 3719 02:34:33,600 --> 02:34:35,240 TYPE 4 GRANT, WHICH WILL SUPPORT 3720 02:34:35,240 --> 02:34:37,960 THEIR LAST TWO YEARS OF THEIR 3721 02:34:37,960 --> 02:34:44,560 CLINICAL TRAINING. 3722 02:34:44,560 --> 02:34:46,280 THIS IS TRACK 1 FOR POST BACKS 3723 02:34:46,280 --> 02:34:49,240 AND RISING SENIORS IN COLLEGE. 3724 02:34:49,240 --> 02:34:51,440 AND THEY HAVE THE AUGUST RECEIPT 3725 02:34:51,440 --> 02:34:53,080 DATE AND THEN SHORTLY 3726 02:34:53,080 --> 02:34:56,160 AFTERWARDS, THEY NEED TO APPLY 3727 02:34:56,160 --> 02:34:57,120 SEPARATELY THROUGH AN 3728 02:34:57,120 --> 02:34:59,160 INDEPENDENT PROCESS THROUGH THE 3729 02:34:59,160 --> 02:35:00,120 INTRAMURAL GRADUATE PARTNERSHIP 3730 02:35:00,120 --> 02:35:02,600 PROGRAM AND THEY PORTAL FOR THAT 3731 02:35:02,600 --> 02:35:04,560 PROGRAM OPENS FOR APPLICATIONS 3732 02:35:04,560 --> 02:35:06,480 IN AUGUST THROUGH NOVEMBER. 3733 02:35:06,480 --> 02:35:09,720 WE WOULD THEN CONDUCT PEER 3734 02:35:09,720 --> 02:35:11,840 REVIEW BETWEEN OCTOBER AND 3735 02:35:11,840 --> 02:35:16,200 NOVEMBER OF THAT YEAR AND THE 3736 02:35:16,200 --> 02:35:16,840 COUNCIL JANUARY NIAID COUNCIL 3737 02:35:16,840 --> 02:35:19,520 WILL APPROVE THE APPLICATIONS 3738 02:35:19,520 --> 02:35:21,640 AND WE CAN ISSUE THOSE STUDENTS 3739 02:35:21,640 --> 02:35:23,920 WHAT WE CALL AN APPROVAL LETTER, 3740 02:35:23,920 --> 02:35:25,840 WHICH SIMPLY SAYS THEY'RE 3741 02:35:25,840 --> 02:35:27,400 ELIGIBLE FOR FUNDING BUT THE 3742 02:35:27,400 --> 02:35:30,120 STUDENT CAN USE THAT TO THEN 3743 02:35:30,120 --> 02:35:32,880 SUBMIT TO THE IRP PROGRAM AS 3744 02:35:32,880 --> 02:35:37,200 PART OF THEIR APPLICATION 3745 02:35:37,200 --> 02:35:38,360 PACKAGE. 3746 02:35:38,360 --> 02:35:41,000 IRP PROGRAM INTERVIEWS ALL OF 3747 02:35:41,000 --> 02:35:42,720 THEIR CANDIDATES IN FEBRUARY AND 3748 02:35:42,720 --> 02:35:45,080 MAKES A DECISION BY THE END OF 3749 02:35:45,080 --> 02:35:47,560 THAT MONTH. 3750 02:35:47,560 --> 02:35:48,880 AND THEN NIAID WOULD AT THAT 3751 02:35:48,880 --> 02:35:55,960 POINT, TRANSFER THE GRANT TO THE 3752 02:35:55,960 --> 02:35:59,680 FUTURE INSTITUTE WHEN THEY HAVE 3753 02:35:59,680 --> 02:36:02,280 THE INTRAMURAL LAB AND THEREFORE 3754 02:36:02,280 --> 02:36:04,440 KNOW WHICH INSTITUTE WILL MAKE 3755 02:36:04,440 --> 02:36:09,120 YOU THE AWARD AND WE HAVE TO GO 3756 02:36:09,120 --> 02:36:10,800 TO THAT INSTITUTES COUNCIL AND 3757 02:36:10,800 --> 02:36:13,840 MAY OR JUNE AND THEN WE GET 3758 02:36:13,840 --> 02:36:15,760 FINAL JUST IN TIME INFORMATION 3759 02:36:15,760 --> 02:36:18,600 AND MAKE THAT IC WILL MAKE THE 3760 02:36:18,600 --> 02:36:20,760 AWARD IN JULY OF THAT YEAR. 3761 02:36:20,760 --> 02:36:23,200 AS THEY'RE GETTING READY TO 3762 02:36:23,200 --> 02:36:26,240 MATRICULATE INTO MEDICAL SCHOOL. 3763 02:36:26,240 --> 02:36:27,200 NEXT SLIDE. 3764 02:36:27,200 --> 02:36:31,080 TRACK TWO IS ESSENTIALLY THE 3765 02:36:31,080 --> 02:36:36,880 SAME TIMING AND STEPS AND THE 3766 02:36:36,880 --> 02:36:38,400 STUDENT WILL APPLIANCE AND 3767 02:36:38,400 --> 02:36:41,360 DENTAL OR VET AND IN THEIR YEAR 3768 02:36:41,360 --> 02:36:43,880 AND THEY WOULD THEN GET AT WARD 3769 02:36:43,880 --> 02:36:48,440 IN JUNE OR FULL AFTER FINISHING 3770 02:36:48,440 --> 02:36:50,040 THEIR FIRST YEAR OF SCHOOL AND 3771 02:36:50,040 --> 02:36:51,240 THEY WOULD RECEIVE SUPPORT FOR 3772 02:36:51,240 --> 02:36:52,800 THEY SECOND AND THIRD AND FOURTH 3773 02:36:52,800 --> 02:36:58,720 YEARS OF SCHOOL. 3774 02:36:58,720 --> 02:37:01,240 NOW, SPEAKING OF THE REVIEW 3775 02:37:01,240 --> 02:37:03,160 CRITERIA, SINCE THE TRACK ONE 3776 02:37:03,160 --> 02:37:05,240 STUDENTS WILL NOT KNOW WHICH 3777 02:37:05,240 --> 02:37:08,280 SCHOOL THEY'LL ATTEND AND WHICH 3778 02:37:08,280 --> 02:37:09,480 LAB THEY'LL WORK WITH AT THE 3779 02:37:09,480 --> 02:37:12,440 TIME OF APPLICATION, THIS 3780 02:37:12,440 --> 02:37:14,680 FELLOWSHIP APPLICATION, UNLIKE 3781 02:37:14,680 --> 02:37:16,600 MOST NIH FELLOWSHIP 3782 02:37:16,600 --> 02:37:18,760 APPLICATIONS, WILL NOT REQUIRE 3783 02:37:18,760 --> 02:37:20,760 RESEARCH PROPOSALS OR THE 3784 02:37:20,760 --> 02:37:23,880 IDENTIFICATION OF A DISSERTATION 3785 02:37:23,880 --> 02:37:24,400 MENTOR. 3786 02:37:24,400 --> 02:37:25,800 WHILE TRACK STUDENTS MOST LIKELY 3787 02:37:25,800 --> 02:37:27,920 WILL MOW THE ANSWER TO THOSE 3788 02:37:27,920 --> 02:37:29,600 QUESTIONS AT THE TIME THEY 3789 02:37:29,600 --> 02:37:30,960 SUBMIT, WILL STILL PROPOSE THAT 3790 02:37:30,960 --> 02:37:33,200 THE REVIEW CRITERIA BE THE SAME 3791 02:37:33,200 --> 02:37:35,440 FOR BOTH TRACK ONE AND TRACK TWO 3792 02:37:35,440 --> 02:37:45,840 STUDENTS FOR FAIRNESS. 3793 02:37:54,680 --> 02:37:57,280 AT SCIENTIFIC MEETINGS AND THE 3794 02:37:57,280 --> 02:37:58,000 STUDENTS' STATEMENT OF 3795 02:37:58,000 --> 02:37:59,160 COMMITMENT AND INTEREST IN A 3796 02:37:59,160 --> 02:38:01,000 CAREER IN BIOMEDICAL RESEARCH 3797 02:38:01,000 --> 02:38:03,200 AND LASTLY THE STRENGTHS OF 3798 02:38:03,200 --> 02:38:08,840 THREE LETTERS OF 3799 02:38:08,840 --> 02:38:09,240 RECOMMENDATIONS. 3800 02:38:09,240 --> 02:38:11,480 THE COST OF THE PROGRAM IS 3801 02:38:11,480 --> 02:38:13,280 DESIGNED TO BE ROUGHLY EQUAL TO 3802 02:38:13,280 --> 02:38:14,560 THE CURRENT COST THAT WE HAVE 3803 02:38:14,560 --> 02:38:19,560 UNDER THE MSTP PROGRAM AND IT'S 3804 02:38:19,560 --> 02:38:22,560 BASICALLY AROUND 57,000 A YEAR 3805 02:38:22,560 --> 02:38:24,200 CURRENTLY FOR EACH YEAR OF 3806 02:38:24,200 --> 02:38:25,760 EXTRAMURAL SUPPORT BUT THIS IS 3807 02:38:25,760 --> 02:38:27,960 BASED ON THE NSRA STIPEND 3808 02:38:27,960 --> 02:38:32,040 GUIDELINES SO THAT COST WILL GO 3809 02:38:32,040 --> 02:38:35,600 UP AS THE STAPENS GO UP EVERY 3810 02:38:35,600 --> 02:38:37,120 FEW YEARS, I'M SURE YOU ARE 3811 02:38:37,120 --> 02:38:41,240 AWARE OF THOSE CHANGES IN 3812 02:38:41,240 --> 02:38:41,600 STIPEND. 3813 02:38:41,600 --> 02:38:42,880 THE STUDENTS TAKES A LEAVE OF 3814 02:38:42,880 --> 02:38:45,040 ABSENCE FROM SCHOOL AND FUNDING 3815 02:38:45,040 --> 02:38:48,800 UNDER THE FM1 GRANT AND THE 3816 02:38:48,800 --> 02:38:51,920 INTRAMURAL PROGRAM ACTUALLY 3817 02:38:51,920 --> 02:38:52,920 HIRES THAT STUDENT AS AN FELLOW 3818 02:38:52,920 --> 02:38:55,720 AND COVERS ALL OF THEIR COST AND 3819 02:38:55,720 --> 02:38:59,000 SALARY DURING THE DURATION OF 3820 02:38:59,000 --> 02:38:59,720 THIS PHASE. 3821 02:38:59,720 --> 02:39:01,960 IT'S GOING TO BE IMPORTANT, ONCE 3822 02:39:01,960 --> 02:39:04,480 WE ANNOUNCE THIS NEW TISH TIVE 3823 02:39:04,480 --> 02:39:06,600 FOR NIAID AND OUR IC PARTNERS TO 3824 02:39:06,600 --> 02:39:08,560 LAUNCH SEVERAL OUTREACH 3825 02:39:08,560 --> 02:39:08,880 ACTIVITIES. 3826 02:39:08,880 --> 02:39:10,880 AND INCLUDING PROVIDING PROGRAM 3827 02:39:10,880 --> 02:39:12,680 INFORMATION ON OUR WEBSITE AND 3828 02:39:12,680 --> 02:39:15,800 OUR PARTNERS ICs' WEB SITES BY 3829 02:39:15,800 --> 02:39:18,440 PROVIDING WEBINARS AND WORKSHOPS 3830 02:39:18,440 --> 02:39:20,240 AND AN INSTRUCTION MANUAL FOR 3831 02:39:20,240 --> 02:39:21,680 APPLICANTS TO HELP WALK THEM 3832 02:39:21,680 --> 02:39:24,160 THROUGH THE NIH APPLICATIONS 3833 02:39:24,160 --> 02:39:24,560 PROCESS. 3834 02:39:24,560 --> 02:39:26,160 AND WE NEED TO HAVE GREAT 3835 02:39:26,160 --> 02:39:29,120 OUTREACH TO MEDICAL SCHOOLS AND 3836 02:39:29,120 --> 02:39:30,320 UNDERGRADUATE INSTITUTION AND 3837 02:39:30,320 --> 02:39:33,480 PROFESSIONAL SOCIETIES. 3838 02:39:33,480 --> 02:39:34,880 SO I THANK YOU FOR YOUR TIME AND 3839 02:39:34,880 --> 02:39:39,920 I'M HAPPY TO TAKE ANY QUESTIONS. 3840 02:39:39,920 --> 02:39:41,960 >> THANK YOU, Dr. FENTON. 3841 02:39:41,960 --> 02:39:44,240 VERY EXCITING, EXCITING PROGRAM 3842 02:39:44,240 --> 02:39:47,640 THAT I THINK WILL GENERATE 3843 02:39:47,640 --> 02:39:48,640 TREMENDOUS INTEREST. 3844 02:39:48,640 --> 02:39:53,320 WE HAVE TIME FOR SOME QUESTIONS. 3845 02:39:53,320 --> 02:39:58,560 >> SO, I KNOW I'VE ASKED A LOT 3846 02:39:58,560 --> 02:40:01,920 OF QUESTIONS AND -- 3847 02:40:01,920 --> 02:40:02,600 >> KEEP ASKING. 3848 02:40:02,600 --> 02:40:05,280 >> I'M CONFUSED. 3849 02:40:05,280 --> 02:40:09,120 IF YOU ADMIT OR GIVE A GRANT TO 3850 02:40:09,120 --> 02:40:12,640 AN MSTP STUDENTS, WHAT HAPPENS 3851 02:40:12,640 --> 02:40:13,480 TO THE MONEY? 3852 02:40:13,480 --> 02:40:15,600 DO YOU SHARE THE COST OF THAT 3853 02:40:15,600 --> 02:40:18,440 WITH THE INSTITUTION? 3854 02:40:18,440 --> 02:40:20,320 OR DOES THIS PROGRAM TAKE OVER 3855 02:40:20,320 --> 02:40:21,040 THAT COST? 3856 02:40:21,040 --> 02:40:24,960 >> WELL, FIRST OF ALL, THE MSTP 3857 02:40:24,960 --> 02:40:27,600 PROGRAM IS SUNSETTING ITS OPTION 3858 02:40:27,600 --> 02:40:30,720 OF ALLOWING STUDENTS TO DO THEIR 3859 02:40:30,720 --> 02:40:33,200 DISSERTATION RESEARCH AT THE NIH 3860 02:40:33,200 --> 02:40:33,680 CAMPUS. 3861 02:40:33,680 --> 02:40:35,320 SO THIS PROGRAM IS SUBSTITUTING 3862 02:40:35,320 --> 02:40:35,920 FOR THAT. 3863 02:40:35,920 --> 02:40:38,520 BUT THE WAY IT IS WORKED IN THE 3864 02:40:38,520 --> 02:40:41,960 PAST, IS THAT UNDER THE MSTP, 3865 02:40:41,960 --> 02:40:44,000 THE INSTITUTION RECEIVES A T-32 3866 02:40:44,000 --> 02:40:46,040 GRANT WITH A CERTAIN NUMBER OF 3867 02:40:46,040 --> 02:40:49,640 SLOTS AND THE FUNDS TO SUPPORT 3868 02:40:49,640 --> 02:40:49,960 THOSE SLOTS. 3869 02:40:49,960 --> 02:40:55,080 THE STUDENT THAT MATRICULATE GET 3870 02:40:55,080 --> 02:40:56,240 INTO A SLOT AND IF THAT -- 3871 02:40:56,240 --> 02:40:59,920 AGAIN, THE T32 IS HOUSED AT 3872 02:40:59,920 --> 02:41:01,680 NIGMS SO LET'S SAY A STUDENT 3873 02:41:01,680 --> 02:41:09,720 WANTS TO DO A MIKE OWE BIOLOGY 3874 02:41:09,720 --> 02:41:13,240 DISSERTAT 3875 02:41:13,240 --> 02:41:14,040 DISSERTATION, NIAID WOULD PAY 3876 02:41:14,040 --> 02:41:15,240 FOR THE STUDENT DURING THEIR 3877 02:41:15,240 --> 02:41:16,760 FOUR YEARS OF SCHOOLING. 3878 02:41:16,760 --> 02:41:19,040 >> UNDER THE MSPP PROGRAM, WE'RE 3879 02:41:19,040 --> 02:41:21,800 JUST SIMPLY PAYING DIRECTLY. 3880 02:41:21,800 --> 02:41:23,120 IT'S AN INDIVIDUAL FELLOWSHIP 3881 02:41:23,120 --> 02:41:26,400 GRANT AND BE WE'RE NOT PAYING 3882 02:41:26,400 --> 02:41:28,480 THROUGH A T32. 3883 02:41:28,480 --> 02:41:31,600 >> Dr. GANDHI, QUESTION. 3884 02:41:31,600 --> 02:41:35,000 >> YEAH, I MEAN, I ASKED THIS 3885 02:41:35,000 --> 02:41:37,000 BEFORE BUT I'M TRYING TO 3886 02:41:37,000 --> 02:41:40,440 UNDERSTAND THAT DOES THIS HE CAD 3887 02:41:40,440 --> 02:41:45,320 TO NON MEDICAL PH.Ds IN 3888 02:41:45,320 --> 02:41:46,600 PHARMACY, DENTAL? 3889 02:41:46,600 --> 02:41:49,000 IN A WAY AND NURSING, IN A WAY 3890 02:41:49,000 --> 02:41:51,760 THAT WE DIDN'T, THAT THE MSTP 3891 02:41:51,760 --> 02:41:52,320 DIDN'T SERVE? 3892 02:41:52,320 --> 02:41:53,920 >> WELL, WE'RE DEFINITELY GOING 3893 02:41:53,920 --> 02:41:56,560 TO BE INCLUDING MEDICAL, DENTAL 3894 02:41:56,560 --> 02:41:58,320 AND VETERINARY. 3895 02:41:58,320 --> 02:42:00,400 WE WILL LIKELY INCLUDE SOME OF 3896 02:42:00,400 --> 02:42:03,880 THE OTHER CLINICAL DOCTOR ATS 3897 02:42:03,880 --> 02:42:04,760 BUT ONE OF THE QUESTION THAT 3898 02:42:04,760 --> 02:42:07,120 COME UP RECENTLY ABOUT RNs AND 3899 02:42:07,120 --> 02:42:10,960 WHETHER THIS WOULD BE AN RN PH.D 3900 02:42:10,960 --> 02:42:11,320 OPPORTUNITY. 3901 02:42:11,320 --> 02:42:13,080 BECAUSE OF THE GRANT MECHANISM, 3902 02:42:13,080 --> 02:42:17,080 IT HAS TO BE A COMBINED DOCTORAL 3903 02:42:17,080 --> 02:42:19,360 DEGREE SO, IT WOULDN'T BE A 3904 02:42:19,360 --> 02:42:20,760 PATHWAY FOR SOMEONE WHO WANTED 3905 02:42:20,760 --> 02:42:24,320 DO AN RN, PH.D, THEY WOULD HAVE 3906 02:42:24,320 --> 02:42:28,200 TO GO THROUGH THE REGULAR THD 3907 02:42:28,200 --> 02:42:29,520 FELLOWSHIP GRANT PATHWAY TO DO 3908 02:42:29,520 --> 02:42:29,720 THAT. 3909 02:42:29,720 --> 02:42:32,960 >> THANK YOU. 3910 02:42:32,960 --> 02:42:39,080 >> CAN I ASK YOU TWO QUESTIONS. 3911 02:42:39,080 --> 02:42:41,320 IN THE FOUR CRITERIA YOU LISTED 3912 02:42:41,320 --> 02:42:44,040 I DON'T BELIEVE THAT DIVERSITY 3913 02:42:44,040 --> 02:42:46,960 WAS ONE OF THOSE CRITERIA 3914 02:42:46,960 --> 02:42:47,560 PERHAPS IT WAS. 3915 02:42:47,560 --> 02:42:49,720 WHAT I WANT TODAY ASK AND THIS 3916 02:42:49,720 --> 02:42:57,720 CAME UP EARLIER, HOW FOR THE T32 3917 02:42:57,720 --> 02:43:02,200 IT'S CRITERIA FOR SUCCESS AND 3918 02:43:02,200 --> 02:43:03,040 THE PROGRAM. 3919 02:43:03,040 --> 02:43:05,160 WILL THAT BE VIEWED IN THIS 3920 02:43:05,160 --> 02:43:07,640 PROGRAM INTERNALLY AS ONE OF THE 3921 02:43:07,640 --> 02:43:10,480 CRITERIA IN EVALUATING THE 3922 02:43:10,480 --> 02:43:11,240 APPLICATIONS IS THE FIRST 3923 02:43:11,240 --> 02:43:12,560 QUESTION AND THE SECOND, I 3924 02:43:12,560 --> 02:43:13,960 HADN'T REALIZED BEFORE YOU 3925 02:43:13,960 --> 02:43:17,040 PRESENTED THERE WAS NO RESEARCH 3926 02:43:17,040 --> 02:43:21,640 PROPOSAL NOTED SO HOW WILL 3927 02:43:21,640 --> 02:43:26,200 APPLICANTS AND REVIEWERS KNOW 3928 02:43:26,200 --> 02:43:27,840 WHERE SOMEONE MIGHT END UP OR IS 3929 02:43:27,840 --> 02:43:31,800 THIS TO FIND COMMITTED PEOPLE 3930 02:43:31,800 --> 02:43:33,600 WHO HAVE DONE RESEARCH AND 3931 02:43:33,600 --> 02:43:34,760 EXPECT THEY WILL FIND A GOOD 3932 02:43:34,760 --> 02:43:36,200 PLACE TO GO? 3933 02:43:36,200 --> 02:43:39,480 >> LET ME ANSWER YOUR SECOND 3934 02:43:39,480 --> 02:43:40,800 QUESTION FIRST IF I COULD. 3935 02:43:40,800 --> 02:43:42,680 IF YOU THINK ABOUT A STUDENT 3936 02:43:42,680 --> 02:43:44,840 COMING INTO THE MSTP PROGRAM, 3937 02:43:44,840 --> 02:43:47,160 THEY GET A SLOT ON A T32. 3938 02:43:47,160 --> 02:43:48,960 THEY HAVE NO IDEA WHAT THEIR 3939 02:43:48,960 --> 02:43:51,000 RESEARCH PROJECT IS GOING TO BE, 3940 02:43:51,000 --> 02:43:52,640 WHO THEIR MENTOR IS GOING TO BE, 3941 02:43:52,640 --> 02:43:54,600 WHETHER IT'S IN THE INTRAMURAL 3942 02:43:54,600 --> 02:43:55,360 PROGRAM OR NOT. 3943 02:43:55,360 --> 02:43:59,000 SO THIS ISN'T ALL THAT 3944 02:43:59,000 --> 02:44:00,080 DIFFERENT. 3945 02:44:00,080 --> 02:44:02,880 WE DO PUT -- WE WILL PUT IN THE 3946 02:44:02,880 --> 02:44:04,080 FOA A DESCRIPTION OF THE 3947 02:44:04,080 --> 02:44:05,600 RESEARCHES AVAILABLE THROUGH THE 3948 02:44:05,600 --> 02:44:07,160 INTRAMURAL PROGRAM AND I THINK 3949 02:44:07,160 --> 02:44:09,280 EVERYBODY'S AWARE OF 3950 02:44:09,280 --> 02:44:10,400 HIGH-QUALITY RESEARCH THAT IT 3951 02:44:10,400 --> 02:44:12,840 TAKES PLACE AT THE NIH CAMPUS. 3952 02:44:12,840 --> 02:44:14,600 BUT, THIS IS GOING TO BE VERY 3953 02:44:14,600 --> 02:44:18,240 SIMILAR TO THE EXISTING PROGRAM 3954 02:44:18,240 --> 02:44:21,880 SINCE A STUDENT ON A T32 SLOT IN 3955 02:44:21,880 --> 02:44:25,720 THE MSTP WILL BE IDENTIFIED A 3956 02:44:25,720 --> 02:44:27,120 MENTOR IN A RESEARCH PROJECT IN 3957 02:44:27,120 --> 02:44:29,480 THE COURSE OF THEIR FIRST YEAR 3958 02:44:29,480 --> 02:44:31,840 IN MEDICAL SCHOOL. 3959 02:44:31,840 --> 02:44:34,360 AS FAR AS YOUR FIRST QUESTION, I 3960 02:44:34,360 --> 02:44:38,000 WOULD RATHER HAVE YOU TALK TO MY 3961 02:44:38,000 --> 02:44:38,400 LAWYER. 3962 02:44:38,400 --> 02:44:39,960 THE ANSWER IS, IS THAT IF YOU 3963 02:44:39,960 --> 02:44:43,880 ARE DOING AN INTERN -- AN 3964 02:44:43,880 --> 02:44:45,240 INSTITUTIONAL GRANT, WE CAN 3965 02:44:45,240 --> 02:44:46,640 ENCOURAGE INSTITUTIONS THROUGH 3966 02:44:46,640 --> 02:44:50,560 THE FOA TO DO THEIR BEST TO 3967 02:44:50,560 --> 02:44:53,600 ENCOURAGE AND SUPPORT DIEA AND 3968 02:44:53,600 --> 02:44:56,680 IN THEIR RECRUITMENT PRACTICES. 3969 02:44:56,680 --> 02:45:00,280 WE CANNOT MAKE AN AWARD BASED ON 3970 02:45:00,280 --> 02:45:02,120 RACE, SEX, GENDER OR ANY OF 3971 02:45:02,120 --> 02:45:03,240 THOSE CRITERIA. 3972 02:45:03,240 --> 02:45:06,120 LEGALLY WE'RE NOT ALLOWED TO DO 3973 02:45:06,120 --> 02:45:06,520 THAT. 3974 02:45:06,520 --> 02:45:09,360 BY SAYING THAT WE WANT THIS 3975 02:45:09,360 --> 02:45:13,840 PROGRAM TO -- WE ENCOURAGE 3976 02:45:13,840 --> 02:45:17,160 SCHOOLS HBCUs AND MSIs TO 3977 02:45:17,160 --> 02:45:18,240 PARTICIPATE IN THE PROGRAM BY 3978 02:45:18,240 --> 02:45:19,640 OPENING IT UP TO SCHOOLS OUTSIDE 3979 02:45:19,640 --> 02:45:22,520 OF THE MSTP PROGRAMS TO REACH 3980 02:45:22,520 --> 02:45:27,120 OUT TO MORE DIVERSE COLLEGES AND 3981 02:45:27,120 --> 02:45:27,800 UNIVERSITIES. 3982 02:45:27,800 --> 02:45:30,320 WE'RE HOPING THAT WE WILL 3983 02:45:30,320 --> 02:45:31,240 AUTOMATICALLY INCREASE THE 3984 02:45:31,240 --> 02:45:33,000 DIVERSITY OF THE APPLICANT POOL 3985 02:45:33,000 --> 02:45:35,520 BY DOING THAT BUT WE ACTUALLY 3986 02:45:35,520 --> 02:45:38,200 CAN'T TAKE RACE, SEX, GENDER AND 3987 02:45:38,200 --> 02:45:41,600 INTO ACCOUNT AND DETERMINING 3988 02:45:41,600 --> 02:45:41,840 FUNDING. 3989 02:45:41,840 --> 02:45:42,680 >> THANK YOU. 3990 02:45:42,680 --> 02:45:45,960 THAT'S HELPFUL AND I DO THINK 3991 02:45:45,960 --> 02:45:47,640 THAT BY FOCUSING ON A DIVERSE 3992 02:45:47,640 --> 02:45:51,880 SET OF RESEARCH EXPERIENCES, AND 3993 02:45:51,880 --> 02:45:53,640 VARIOUS POPULATIONS THAT THAT 3994 02:45:53,640 --> 02:45:56,120 CAN BE EXPANDED QUITE WELL. 3995 02:45:56,120 --> 02:45:58,720 SO, I THINK THAT CAN BE 3996 02:45:58,720 --> 02:45:59,600 SUCCESSFUL. 3997 02:45:59,600 --> 02:46:00,880 MONICA, DO YOU HAVE NUR Y YOU 3998 02:46:00,880 --> 02:46:06,760 ARE HAND UP AGAIN OR STILL IN 3999 02:46:06,760 --> 02:46:08,800 UP? 4000 02:46:08,800 --> 02:46:10,120 OR MAYBE NOT AT ALL. 4001 02:46:10,120 --> 02:46:16,320 I DON'T KNOW. 4002 02:46:16,320 --> 02:46:20,640 >> SO STU FOR THIS PROGRAM AND 4003 02:46:20,640 --> 02:46:23,120 FOR WE ALL AGREE NEEDING 4004 02:46:23,120 --> 02:46:26,560 HIGH-QUALITY PHYSICIAN 4005 02:46:26,560 --> 02:46:30,680 SCIENTISTS VETERINARY AS WELL AS 4006 02:46:30,680 --> 02:46:34,880 DENTAL WILL BE REALLY VALUE-ADD. 4007 02:46:34,880 --> 02:46:37,080 QUESTION ABOUT QUESTIONS WILL 4008 02:46:37,080 --> 02:46:39,520 TOPIC AREAS WILL THERE BE SOME 4009 02:46:39,520 --> 02:46:43,440 ATTEMPT TO SORT OF IDENTIFY 4010 02:46:43,440 --> 02:46:44,520 PARTICULAR HIGH VALUE AREAS THAT 4011 02:46:44,520 --> 02:46:47,840 ARE NEEDED BY THE NIH AND ARE 4012 02:46:47,840 --> 02:46:49,600 ALIGNED WITH THE PRIORITIES THAT 4013 02:46:49,600 --> 02:46:50,680 WILL BE GIVEN PREFERENCE? 4014 02:46:50,680 --> 02:46:52,440 I KNOW YOU MENTIONED THAT THERE 4015 02:46:52,440 --> 02:46:55,320 MAY NOT BE A CLEAR PATH TO 4016 02:46:55,320 --> 02:46:59,320 SELECT THE AREAS OF STUDINESSLY 4017 02:46:59,320 --> 02:47:00,840 AND JUST CURIOUS AROUND THE 4018 02:47:00,840 --> 02:47:02,360 TOPIC AREAS THAT WOULD BE 4019 02:47:02,360 --> 02:47:03,240 PRIORITIZE THE? 4020 02:47:03,240 --> 02:47:08,120 >> WELL, YOU KNOW, THE ABILITY 4021 02:47:08,120 --> 02:47:10,520 TO DO THAT PRIORITIZATION IS 4022 02:47:10,520 --> 02:47:12,520 LIMITED GIVEN THAT WE DON'T 4023 02:47:12,520 --> 02:47:15,840 REQUIRE A RESEARCH PROJECT TO BE 4024 02:47:15,840 --> 02:47:17,600 PROPOSED IN THE GRANT 4025 02:47:17,600 --> 02:47:19,240 APPLICATION ITSELF. 4026 02:47:19,240 --> 02:47:21,920 AND AS I SAID BEFORE, AS WE 4027 02:47:21,920 --> 02:47:23,800 DISCUSSED, AT THE TIME THESE 4028 02:47:23,800 --> 02:47:25,720 APPLICATIONS ARE REVIEWED, FOR 4029 02:47:25,720 --> 02:47:29,120 AT LEAST FOR THE TRACK ONE 4030 02:47:29,120 --> 02:47:31,400 STUDENTS, THAT THEY WON'T HAVE A 4031 02:47:31,400 --> 02:47:32,920 CLEAR ANSWER FOR WHERE THEIR 4032 02:47:32,920 --> 02:47:35,280 MENTOR AND HOME INSTITUTIONS 4033 02:47:35,280 --> 02:47:37,880 WILL BE IN THE INTRAMURAL 4034 02:47:37,880 --> 02:47:39,720 PROGRAM AND CHANCES ARE, THEY'RE 4035 02:47:39,720 --> 02:47:44,600 VERY LIKELY TO KNOW THE TYPES OF 4036 02:47:44,600 --> 02:47:45,880 RESEARCH THAT THEY'RE INTERESTED 4037 02:47:45,880 --> 02:47:47,720 IN AND A LOT OF THESE STUDENTS 4038 02:47:47,720 --> 02:47:50,600 ARE GOING TO HAVE PRIOR RESEARCH 4039 02:47:50,600 --> 02:47:53,200 EXPERIENCE AND HAVE VERY STRONG 4040 02:47:53,200 --> 02:47:54,760 IDEAS AT LEAST UP FRONT, OF 4041 02:47:54,760 --> 02:47:56,160 WHERE THEY THINK THEY MIGHT WANT 4042 02:47:56,160 --> 02:47:58,240 TO WORK IN TERMS OF THEIR 4043 02:47:58,240 --> 02:47:59,080 SCIENCE AREAS. 4044 02:47:59,080 --> 02:48:00,880 WE'RE NOT TRYING TO PRIORITIZE 4045 02:48:00,880 --> 02:48:03,600 ONE AREA OVER ANOTHER, IN THE 4046 02:48:03,600 --> 02:48:05,840 CASE OF NIAID, WE'LL BE LOOKING 4047 02:48:05,840 --> 02:48:08,680 AT STUDENTS THAT FIT THE MISSION 4048 02:48:08,680 --> 02:48:11,880 OR FOLLOW THE MISSION AREAS OF 4049 02:48:11,880 --> 02:48:14,200 NIAID AND I THINK THE NEED FOR 4050 02:48:14,200 --> 02:48:15,360 PHYSICIANS SCIENTISTS IS GREAT 4051 02:48:15,360 --> 02:48:17,520 ENOUGH AS WE WANT TO TAKE EVERY 4052 02:48:17,520 --> 02:48:19,400 OPPORTUNITY TO BE ABLE TO TRAIN 4053 02:48:19,400 --> 02:48:21,160 PEOPLE AND THIS CAREER PATH AS 4054 02:48:21,160 --> 02:48:22,280 WE CAN. 4055 02:48:22,280 --> 02:48:25,440 AND TO TROY TO PRE SELECT EARLY 4056 02:48:25,440 --> 02:48:27,480 BASED ON SOME PRIORITIZATION OF 4057 02:48:27,480 --> 02:48:35,480 AN INSTITUTES RESEARCH I THINK 4058 02:48:35,480 --> 02:48:37,080 IS NOT HELPING US GET PEOPLE IN 4059 02:48:37,080 --> 02:48:37,920 THE PIPELINE AS WE WOULD LIKE. 4060 02:48:37,920 --> 02:48:38,800 >> UNDERSTOOD. 4061 02:48:38,800 --> 02:48:39,080 THANK YOU. 4062 02:48:39,080 --> 02:48:39,400 >> GREAT. 4063 02:48:39,400 --> 02:48:39,840 THANK YOU. 4064 02:48:39,840 --> 02:48:41,680 THANK YOU Dr. FENTON. 4065 02:48:41,680 --> 02:48:47,080 LET ME REMIND, ASK PEOPLE TO 4066 02:48:47,080 --> 02:48:51,640 VOTE ON THIS CONCEPT PROPOSAL 4067 02:48:51,640 --> 02:48:52,720 AND PLEASE. 4068 02:48:52,720 --> 02:48:56,800 AND I KNOW THAT Dr. 4069 02:48:56,800 --> 02:48:58,560 DIEFFENBACH WOULD LIKE TO MAKE A 4070 02:48:58,560 --> 02:49:04,280 COUPLE OF ANNOUNCEMENTS BEFORE 4071 02:49:04,280 --> 02:49:04,800 WE CLOSE. 4072 02:49:04,800 --> 02:49:06,640 THANK YOU TO EVERYONE FOR THESE 4073 02:49:06,640 --> 02:49:08,640 REALLY FANTASTIC PRESENTATIONS 4074 02:49:08,640 --> 02:49:12,640 AND AS ALWAYS, A BREADTH OF 4075 02:49:12,640 --> 02:49:15,680 SCIENCE AND INTERESTING EXCITING 4076 02:49:15,680 --> 02:49:17,680 AND IMPORTANT CONCEPT AND 4077 02:49:17,680 --> 02:49:18,000 PROPOSALS. 4078 02:49:18,000 --> 02:49:19,240 SO THANK YOU TO EVERYONE FOR ALL 4079 02:49:19,240 --> 02:49:22,480 OF THEIR EFFORTS HERE. 4080 02:49:22,480 --> 02:49:24,120 >> THANK YOU. 4081 02:49:24,120 --> 02:49:27,240 I WANT TO ECHO YOUR COMMENTS 4082 02:49:27,240 --> 02:49:29,720 ABOUT THE BREADTH AND THE GREAT 4083 02:49:29,720 --> 02:49:31,640 THING ABOUT OUR SCIENCE, USING 4084 02:49:31,640 --> 02:49:33,760 THE COMMITTEE TO HELP 4085 02:49:33,760 --> 02:49:35,600 CROWDSOURCE, IT ONLY IS BETTER 4086 02:49:35,600 --> 02:49:36,560 THROUGH THE INPUT OF THE 4087 02:49:36,560 --> 02:49:37,880 COMMITTEE AND I APPRECIATE 4088 02:49:37,880 --> 02:49:39,640 EVERYBODY'S TIME ENERGY AND 4089 02:49:39,640 --> 02:49:40,760 THOUGHTFUL LESS AS THEY THINK 4090 02:49:40,760 --> 02:49:42,760 ABOUT THE CONCEPTS AND SCIENCE 4091 02:49:42,760 --> 02:49:44,480 REPORTING FORWARD. 4092 02:49:44,480 --> 02:49:47,920 SO, IT'S A TEAM EFFORT AND YOU 4093 02:49:47,920 --> 02:49:50,120 AS OUR ARAC ARE AN IMPORTANT 4094 02:49:50,120 --> 02:49:51,720 PART OF OUR TEAM. 4095 02:49:51,720 --> 02:49:54,880 SECOND, WE HAVE NO PUBLIC 4096 02:49:54,880 --> 02:49:58,400 COMMENTS TODAY AND WE DON'T HAVE 4097 02:49:58,400 --> 02:50:00,200 TO READ INTO THE RECORD. 4098 02:50:00,200 --> 02:50:03,920 AND LAST IS WE NEED AN ON BLOCK 4099 02:50:03,920 --> 02:50:07,400 ACTION BY SHOW OF HANDS OR SOME 4100 02:50:07,400 --> 02:50:10,360 SORT OF VOICE VOTE THAT THE 4101 02:50:10,360 --> 02:50:11,800 ENTIRE PROCEEDINGS HAS BEEN 4102 02:50:11,800 --> 02:50:16,280 ACCEPTED BY THE COMMITTEE. 4103 02:50:16,280 --> 02:50:18,360 SO, IF FOLLOWING ROBERTS RULES 4104 02:50:18,360 --> 02:50:23,600 OF ORDER LET'S HAVE A MOTION TO 4105 02:50:23,600 --> 02:50:25,000 APPROVAL OF TODAY'S ACTIVITIES. 4106 02:50:25,000 --> 02:50:26,440 >> I WILL MAKE A MOTION TO 4107 02:50:26,440 --> 02:50:27,880 APPROVE TODAY'S ACTIVITIES, IF I 4108 02:50:27,880 --> 02:50:28,040 CAN. 4109 02:50:28,040 --> 02:50:29,480 >> AND I GUESS WE'LL NEED A 4110 02:50:29,480 --> 02:50:29,720 SECOND. 4111 02:50:29,720 --> 02:50:31,920 >> SECOND. 4112 02:50:31,920 --> 02:50:42,560 >> AND THEN LET'S HAVE TH AYE AD 4113 02:50:42,800 --> 02:50:44,800 THE NAYs. 4114 02:50:44,800 --> 02:50:46,680 HEARING NONE, WE HAVE OUR BLOCK 4115 02:50:46,680 --> 02:50:48,960 APPROVAL AND I APPRECIATE 4116 02:50:48,960 --> 02:50:52,080 EVERYBODY'S TIME AND ENERGY AND 4117 02:50:52,080 --> 02:50:55,120 EFFORT TODAY. 4118 02:50:55,120 --> 02:50:57,520 AND THANK YOU ALL. 4119 02:50:57,520 --> 02:50:58,960 JUST QUICK REMINDER, JANUARY 4120 02:50:58,960 --> 02:51:01,080 WE'RE NOT IN BETHESDA SO IF YOU 4121 02:51:01,080 --> 02:51:03,560 SHOW UP THERE AND YOU DON'T WORK 4122 02:51:03,560 --> 02:51:06,320 THERE, YOU WILL HAVE TRAVELED 4123 02:51:06,320 --> 02:51:07,320 REALLY UNNECESSARILY BUT ALWAYS 4124 02:51:07,320 --> 02:51:09,520 FUN TO TRAVEL IN JANUARY. 4125 02:51:09,520 --> 02:51:10,760 >> IT'S SO MUCH FUN. 4126 02:51:10,760 --> 02:51:11,400 >> YES. 4127 02:51:11,400 --> 02:51:21,800 >> THANK YOU, EVERYONE!