1 00:00:05,640 --> 00:00:10,240 IT IS MY PLEASURE ALSO 2 00:00:10,240 --> 00:00:15,720 SPECIFICALLY TODAY TO WELCOME 3 00:00:15,720 --> 00:00:22,840 MR. LOUIS SHACKLEFORD, WHO HAS 4 00:00:22,840 --> 00:00:29,320 KINDLY AGREED TO STEP IN AND 5 00:00:29,320 --> 00:00:33,600 FILL THE SHOES OF S TEPHAUN, I'M 6 00:00:33,600 --> 00:00:36,080 NOT SURE, MAYBE THE TWO OF US 7 00:00:36,080 --> 00:00:38,480 COULD FILL HIS SHOES. 8 00:00:38,480 --> 00:00:41,480 IN THE MEANTIME, LOUIS IS ACTING 9 00:00:41,480 --> 00:00:46,320 EXTERNAL RELATIONS DIRECTOR FOR 10 00:00:46,320 --> 00:00:54,160 HVTN AND PUBLIC HEALTH 11 00:00:54,160 --> 00:00:56,040 COMMUNICATIONS, WORK INCLUDES 12 00:00:56,040 --> 00:00:59,400 GUIDING STAKEHOLDER ENGAGEMENT 13 00:00:59,400 --> 00:01:00,640 STRATEGIES, SPEARHEADING 14 00:01:00,640 --> 00:01:01,520 COMMUNITY PARTNERSHIPS, EXTERNAL 15 00:01:01,520 --> 00:01:03,480 STUDY COMMUNICATIONS, DEVELOPING 16 00:01:03,480 --> 00:01:04,360 RESEARCH AWARENESS AND 17 00:01:04,360 --> 00:01:07,000 EDUCATIONAL INITIATIVES FOR 18 00:01:07,000 --> 00:01:08,080 DOMESTIC AND GLOBAL HIV COVID 19 00:01:08,080 --> 00:01:09,720 VACCINE TRIALS. 20 00:01:09,720 --> 00:01:18,560 JOHN ME IN WELCOMING HIM TO 21 00:01:18,560 --> 00:01:19,840 ARAC. 22 00:01:19,840 --> 00:01:26,920 IT IS MY PLEASURE TO LET YOU 23 00:01:26,920 --> 00:01:28,440 KNOW THAT JEANNE MARRAZZO HAS 24 00:01:28,440 --> 00:01:31,080 BEEN SELECTED AS NIAID DIRECTOR, 25 00:01:31,080 --> 00:01:32,400 NO STRANGER TO HIV RESEARCH. 26 00:01:32,400 --> 00:01:36,440 SHE HAS BEEN A FIXTURE IN OUR 27 00:01:36,440 --> 00:01:37,520 COMMUNITIES FOR A VERY LONG 28 00:01:37,520 --> 00:01:37,720 TIME. 29 00:01:37,720 --> 00:01:40,440 IT IS GOING TO BE A REAL 30 00:01:40,440 --> 00:01:43,320 PLEASURE TO HAVE HER AS THE 31 00:01:43,320 --> 00:01:45,160 NIAID DIRECTOR. 32 00:01:45,160 --> 00:01:46,800 SHE STARTS IN TWO WEEKS, WHICH 33 00:01:46,800 --> 00:01:54,480 IS SO MUCH FASTER THAN WE 34 00:01:54,480 --> 00:01:56,160 THOUGHT COULD HAPPEN AND WE'RE 35 00:01:56,160 --> 00:02:06,400 REALLY EXCITED. 36 00:02:18,720 --> 00:02:21,720 TO I WISH I HAD THE SLIDE TO 37 00:02:21,720 --> 00:02:25,880 SHOW YOU, BECAUSE THE ENTIRE 38 00:02:25,880 --> 00:02:30,800 DIRECTOR SUITE IN BUILDING 31 39 00:02:30,800 --> 00:02:32,960 HAS BEEN STRIPPED OF EVERYTHING 40 00:02:32,960 --> 00:02:35,400 TO CONCRETE AND POSTS BECAUSE OF 41 00:02:35,400 --> 00:02:36,480 AN ASBESTOS ISSUE AND NOW THEY 42 00:02:36,480 --> 00:02:37,920 HAVE TO BUILD IT BACK UP. 43 00:02:37,920 --> 00:02:39,360 SO HOPEFULLY SHE WILL HAVE A 44 00:02:39,360 --> 00:02:43,280 SENSE OF WHAT SHE CAN DO AND 45 00:02:43,280 --> 00:02:45,480 HELP DESIGN HER NEW OFFICE. 46 00:02:45,480 --> 00:02:46,800 IN TERMS OF RETIREMENTS, TWO 47 00:02:46,800 --> 00:02:48,200 PEOPLE THAT HAVE RECENTLY 48 00:02:48,200 --> 00:02:48,440 RETIRED. 49 00:02:48,440 --> 00:02:50,280 YOU KNOW I'M NOT ALLOWED TO SAY 50 00:02:50,280 --> 00:02:51,480 THAT ABOUT DR. FAUCI. 51 00:02:51,480 --> 00:02:53,560 HE'S MOVED ON. 52 00:02:53,560 --> 00:02:54,880 MARY HAS RETIRED. 53 00:02:54,880 --> 00:02:58,640 MARY RETIRED IN EARLY AUGUST, 54 00:02:58,640 --> 00:03:02,560 AFTER 12 YEARS OF LEADING THE 55 00:03:02,560 --> 00:03:03,760 HIV VACCINE RESEARCH PROGRAM IN 56 00:03:03,760 --> 00:03:06,760 THE DIVISION OF AIDS. 57 00:03:06,760 --> 00:03:07,760 SHE WAS RESPONSIBLE FOR 58 00:03:07,760 --> 00:03:10,680 OVERSEEING SO MANY OF THE LARGE 59 00:03:10,680 --> 00:03:15,480 HIV VACCINE TRIALS INCLUDING THE 60 00:03:15,480 --> 00:03:17,880 AMP STUDIES, SHE REALLY HELPED 61 00:03:17,880 --> 00:03:19,440 DRIVE THE COVID VACCINE PROGRAM 62 00:03:19,440 --> 00:03:22,960 AND WAS ESSENTIAL IN HELPING TO 63 00:03:22,960 --> 00:03:24,680 GET ALL THE THOSE ACTIVITIES 64 00:03:24,680 --> 00:03:29,640 STOOD UP. 65 00:03:29,640 --> 00:03:32,280 WHEN JOHN MASCOLA SET UP HIS 66 00:03:32,280 --> 00:03:34,480 PROGRAM, HE HAND PICKED HIS TEAM 67 00:03:34,480 --> 00:03:36,760 OF PEOPLE TO HELP DRIVE THE 68 00:03:36,760 --> 00:03:39,280 VACCINE WORK. 69 00:03:39,280 --> 00:03:42,120 HE PICKED MARY AND HE PICKED 70 00:03:42,120 --> 00:03:44,000 COLLEAGUES FROM MHRP, AND THEY 71 00:03:44,000 --> 00:03:45,760 TOGETHER WORKING WITH DIVISION 72 00:03:45,760 --> 00:03:47,160 STAFF AND ACROSS THE GOVERNMENT 73 00:03:47,160 --> 00:03:50,880 REALLY HELPED PUSH THE TRIALS 74 00:03:50,880 --> 00:03:51,120 FORWARD. 75 00:03:51,120 --> 00:03:54,720 SHE ALSO LED ON THE MONOCLONAL 76 00:03:54,720 --> 00:03:55,920 ANTIBODY WORK. 77 00:03:55,920 --> 00:03:58,600 SHE HAS MOVED ON AND RETIRED, 78 00:03:58,600 --> 00:04:02,040 AND JIM LANE HAS BEEN THE LUCKY 79 00:04:02,040 --> 00:04:02,920 RECIPIENT, PULLED THE GOLDEN 80 00:04:02,920 --> 00:04:04,560 TICKET AND GETS TO BE ACTING 81 00:04:04,560 --> 00:04:07,200 DIRECTOR OF THE VACCINE RESEARCH 82 00:04:07,200 --> 00:04:08,160 PROGRAM. 83 00:04:08,160 --> 00:04:12,200 JIM IS AN EXPERIENCED CLINICAL 84 00:04:12,200 --> 00:04:14,320 IMMUNOLOGIST IN THE LAB, SO IT'S 85 00:04:14,320 --> 00:04:19,360 A PLEASURE TO WELCOME JIM TO THE 86 00:04:19,360 --> 00:04:22,400 TABLE AND WORKING WITH HIM QUITE 87 00:04:22,400 --> 00:04:23,640 CLOSELY. 88 00:04:23,640 --> 00:04:26,440 THE SEARCH FOR THE VACCINE 89 00:04:26,440 --> 00:04:29,200 RESEARCH PROGRAM DIRECTOR OPENS 90 00:04:29,200 --> 00:04:32,760 THE SAME DAY AS JEANNE SHOWS UP 91 00:04:32,760 --> 00:04:35,080 HERE IN BETHESDA, SO IF YOU HAVE 92 00:04:35,080 --> 00:04:38,360 CANDIDATES THAT ARE INTERESTED, 93 00:04:38,360 --> 00:04:40,440 JIM WOULD LIKE TO KNOW AND 94 00:04:40,440 --> 00:04:43,080 STRONGLY ENCOURAGE YOU TO SEND 95 00:04:43,080 --> 00:04:44,160 NAMES, ADDRESSES, RÉSUMÉS. 96 00:04:44,160 --> 00:04:47,120 WE WILL BE MOUNTING A GLOBAL 97 00:04:47,120 --> 00:04:49,840 SEARCH AND WE'RE LOOKING FOR A 98 00:04:49,840 --> 00:04:54,400 STRONG CANDIDATE TO TRY TO FILL 99 00:04:54,400 --> 00:04:55,560 MARY'S SHOES. 100 00:04:55,560 --> 00:04:56,840 I'D LIKE TO WELCOME CATHERINE 101 00:04:56,840 --> 00:04:58,040 YEN, WHO REALLY HAS BEEN IN THE 102 00:04:58,040 --> 00:04:59,880 DIVISION FOR A VERY LONG TIME, 103 00:04:59,880 --> 00:05:01,800 BUT SHE'S NOW TAKEN THE ROLE OF 104 00:05:01,800 --> 00:05:04,440 CHIEF OF PROTECTION OF 105 00:05:04,440 --> 00:05:05,320 PARTICIPANTS, EVALUATION, AND 106 00:05:05,320 --> 00:05:07,600 POLICY BRANCH IN THE OFFICE FOR 107 00:05:07,600 --> 00:05:15,920 POLICY IN CLINICAL RESEARCH 108 00:05:15,920 --> 00:05:16,280 OPTIONS; OPCRO. 109 00:05:16,280 --> 00:05:18,760 THIS IS A PROMOTION FOR HER AND 110 00:05:18,760 --> 00:05:20,760 SHE'S LOOKING FORWARD TO 111 00:05:20,760 --> 00:05:22,200 FULFILLING THE ROLES. 112 00:05:22,200 --> 00:05:23,600 GREAT TO HAVE CATHERINE IN THIS 113 00:05:23,600 --> 00:05:23,800 ROLE. 114 00:05:23,800 --> 00:05:26,200 NOW THE FUN PART OF THE 115 00:05:26,200 --> 00:05:27,520 PRESENTATION TODAY, THE BUDGET 116 00:05:27,520 --> 00:05:27,760 UPDATE. 117 00:05:27,760 --> 00:05:31,440 SO THIS IS THE STATE OF PLAY WE 118 00:05:31,440 --> 00:05:33,960 WERE A YEAR AGO. 119 00:05:33,960 --> 00:05:36,080 WE HAD FISCAL YEAR 23 BUDGET 120 00:05:36,080 --> 00:05:38,400 PASSED, IT HAD A NICE INCREASE 121 00:05:38,400 --> 00:05:41,880 FOR US OF 3.8%, BUT COMPARED TO 122 00:05:41,880 --> 00:05:46,800 OTHER INSTITUTES WE WERE A 123 00:05:46,800 --> 00:05:49,080 LITTLE LOWER BUT PLEASED WITH 124 00:05:49,080 --> 00:05:50,960 3.8%. 125 00:05:50,960 --> 00:05:54,880 FAST FORWARD TO NOW, HUGH MADE 126 00:05:54,880 --> 00:05:57,520 THE POINT WHEN HE SHOWED THIS 127 00:05:57,520 --> 00:05:59,680 SLIDE TWO BIGGEST GROWTH AREAS 128 00:05:59,680 --> 00:06:03,000 ARE AT YOUR RIGHT, THE BLUE 129 00:06:03,000 --> 00:06:04,200 CIRCLE THAT'S OD, APPARENTLY 130 00:06:04,200 --> 00:06:09,440 USED TO BE THE SIZE OF NIDCR OR 131 00:06:09,440 --> 00:06:11,160 BUILDING AND FACILITIES. 132 00:06:11,160 --> 00:06:15,120 AND NIA HAS ALSO UNDERGONE 133 00:06:15,120 --> 00:06:15,760 EXPLOSIVE GROWTH. 134 00:06:15,760 --> 00:06:17,960 WHAT WE SEE WHEN WE LOOK AT 135 00:06:17,960 --> 00:06:22,960 FISCAL YEAR 24 IS EVEN UNDER THE 136 00:06:22,960 --> 00:06:25,160 BEST SCENARIO WE'RE AT LEVEL 137 00:06:25,160 --> 00:06:27,920 FUNDING IN THE PRESIDENT'S 138 00:06:27,920 --> 00:06:28,960 BUDGET. 139 00:06:28,960 --> 00:06:31,840 THIS SLIDE SHOWS FOR NIAID WHAT 140 00:06:31,840 --> 00:06:34,360 THE HOUSE AND SENATE MARKS ARE. 141 00:06:34,360 --> 00:06:36,760 YOU SEE THE HOUSE MARK 142 00:06:36,760 --> 00:06:39,520 REPRESENTS A 22.9% CUT FOR 143 00:06:39,520 --> 00:06:40,000 NIAID. 144 00:06:40,000 --> 00:06:43,320 AND THE SENATE MARK IS LEVEL 145 00:06:43,320 --> 00:06:43,800 FUNDING. 146 00:06:43,800 --> 00:06:46,720 THE HOUSE HAS BEEN OUT OF 147 00:06:46,720 --> 00:06:47,080 SESSION. 148 00:06:47,080 --> 00:06:49,240 THEY COME BACK TOMORROW. 149 00:06:49,240 --> 00:06:51,680 AND THEN THE DISCUSSIONS WILL 150 00:06:51,680 --> 00:06:54,920 BEGIN IN EARNEST ABOUT A 151 00:06:54,920 --> 00:06:56,560 CONTINUING RESOLUTION OR PASSING 152 00:06:56,560 --> 00:06:59,400 A BUDGET FOR THE -- ULTIMATELY 153 00:06:59,400 --> 00:07:01,840 WE'LL GET TO PASSING A BUDGET 154 00:07:01,840 --> 00:07:04,000 FOR FISCAL YEAR 24. 155 00:07:04,000 --> 00:07:07,760 THE BEST BETS ARE THAT THE 156 00:07:07,760 --> 00:07:13,960 SENATE WILL HELP TO GUIDE TO A 157 00:07:13,960 --> 00:07:14,840 LEVEL CLEAN CONTINUING 158 00:07:14,840 --> 00:07:16,240 RESOLUTION, HOPEFULLY IT WILL 159 00:07:16,240 --> 00:07:18,760 PASS BY THE 34th OR 35th OF 160 00:07:18,760 --> 00:07:19,160 SEPTEMBER. 161 00:07:19,160 --> 00:07:20,480 BECAUSE THAT'S THE WAY THINGS 162 00:07:20,480 --> 00:07:21,640 WORK IN WASHINGTON. 163 00:07:21,640 --> 00:07:23,280 YOU JUST EXTEND OVER THE WEEKEND 164 00:07:23,280 --> 00:07:24,720 AND THEN MONDAY HOPEFULLY THEY 165 00:07:24,720 --> 00:07:26,240 WILL HAVE SOMETHING SIGNED. 166 00:07:26,240 --> 00:07:27,440 NOW WE'LL SEE WHAT HAPPENS WITH 167 00:07:27,440 --> 00:07:27,640 THAT. 168 00:07:27,640 --> 00:07:30,080 BUT IT'S GOING TO BE A BUMPY 169 00:07:30,080 --> 00:07:32,560 RIDE FOR A WHILE. 170 00:07:32,560 --> 00:07:34,680 SO, WE'RE STARTING THE YEAR VERY 171 00:07:34,680 --> 00:07:35,160 CONSERVATIVELY. 172 00:07:35,160 --> 00:07:36,680 WE'RE GOING TO START WITH AN 173 00:07:36,680 --> 00:07:38,640 ESTABLISHED PAYLINE OF THE 8th 174 00:07:38,640 --> 00:07:42,440 PERCENTILE WITH NEW P.I.s WHO 175 00:07:42,440 --> 00:07:44,720 QUALIFY AT THE 12th 176 00:07:44,720 --> 00:07:45,040 PERCENTILE. 177 00:07:45,040 --> 00:07:48,560 THE INSTITUTE HAS MADE THE 178 00:07:48,560 --> 00:07:51,640 STRATEGIC DECISION NOT TO CUT 179 00:07:51,640 --> 00:07:55,360 NON-COMPETING AND COMPETING 180 00:07:55,360 --> 00:07:56,480 GRANTS, OTHER INSTITUTES HAVE 181 00:07:56,480 --> 00:07:58,440 DONE THAT ROUTINELY. 182 00:07:58,440 --> 00:08:01,480 WE'RE OPTING TO MAINTAIN POINT 183 00:08:01,480 --> 00:08:03,440 OF VIEW NO ADJUSTMENTS SHOULD BE 184 00:08:03,440 --> 00:08:03,680 MADE. 185 00:08:03,680 --> 00:08:05,640 WE'RE STARTING WITH A BUDGET 186 00:08:05,640 --> 00:08:07,520 EXERCISE THAT REDUCES RESEARCH 187 00:08:07,520 --> 00:08:10,240 INITIATIVES BY 30% AND ALL OF 188 00:08:10,240 --> 00:08:12,760 THIS TOTALED UP LISA TO SUCCESS 189 00:08:12,760 --> 00:08:15,040 RATE OF -- LEADS TO A SUCCESS 190 00:08:15,040 --> 00:08:16,680 READ BETWEEN 13 AND 16%. 191 00:08:16,680 --> 00:08:18,360 WE'LL SEE WHAT HAPPENS WHEN WE 192 00:08:18,360 --> 00:08:22,080 GET A FORMAL BUDGET FOR THE 193 00:08:22,080 --> 00:08:22,240 YEAR. 194 00:08:22,240 --> 00:08:23,680 WE'LL MAKE ADJUSTMENTS BASED ON 195 00:08:23,680 --> 00:08:27,080 DOLLARS AVAILABLE TO THE 196 00:08:27,080 --> 00:08:29,440 PAYLINE, AS -- ONCE A FORMAL 197 00:08:29,440 --> 00:08:35,320 BUDGET IS ADOPTED FOR FISCAL 198 00:08:35,320 --> 00:08:35,560 YEAR 24. 199 00:08:35,560 --> 00:08:37,160 WE'LL PROBABLY BE TALKING ABOUT 200 00:08:37,160 --> 00:08:38,720 THIS AGAIN IN JANUARY, MAYBE BY 201 00:08:38,720 --> 00:08:44,200 THEN WE'LL HAVE THE FINAL 202 00:08:44,200 --> 00:08:44,400 BUDGET. 203 00:08:44,400 --> 00:08:49,720 JUST A COUPLE SMALL SCIENTIFIC 204 00:08:49,720 --> 00:08:50,120 UPDATES. 205 00:08:50,120 --> 00:08:56,640 I SHOULD HAVE TURNED IT OFF. 206 00:08:56,640 --> 00:08:57,080 APOLOGIZE. 207 00:08:57,080 --> 00:08:58,280 A COUPLE SCIENTIFIC UPDATES. 208 00:08:58,280 --> 00:09:00,280 FIRST IS THE FINAL ACTION FROM 209 00:09:00,280 --> 00:09:02,880 THE U.S. PREVENTIVE SERVICES 210 00:09:02,880 --> 00:09:05,720 TASK FORCE HAS BEEN PUBLISHED, 211 00:09:05,720 --> 00:09:13,720 MAKING LONG-ACTING PrEP AND 212 00:09:13,720 --> 00:09:16,440 ORAL PrEP BOTH TDF AVAILABLE 213 00:09:16,440 --> 00:09:18,520 OR RECOMMENDED AS GRADE A UNDER 214 00:09:18,520 --> 00:09:20,720 THE WAY THE LEGISLATION HAS BEEN 215 00:09:20,720 --> 00:09:23,120 WRITTEN, BOTH THESE SHOULD ALL 216 00:09:23,120 --> 00:09:24,640 BE AVAILABLE THROUGH INSURANCE 217 00:09:24,640 --> 00:09:26,840 FREE OF CHARGE. 218 00:09:26,840 --> 00:09:29,360 HOWEVER MANY ARE AWARE THERE'S 219 00:09:29,360 --> 00:09:32,320 MOVEMENT FROM THE FIFTH CIRCUIT 220 00:09:32,320 --> 00:09:34,080 TO STRIP THESE KINDS OF THINGS 221 00:09:34,080 --> 00:09:36,240 OUT OF THE LEGISLATION SO WE'LL 222 00:09:36,240 --> 00:09:37,520 SEE WHAT HAPPENS. 223 00:09:37,520 --> 00:09:39,200 FOR NOW, IF THERE IS NO CHANGE, 224 00:09:39,200 --> 00:09:41,400 WE SHOULD BE ABLE TO GET TO A 225 00:09:41,400 --> 00:09:43,560 GOOD PLACE AND HAVE THESE 226 00:09:43,560 --> 00:09:44,120 AVAILABLE. 227 00:09:44,120 --> 00:09:47,400 IT'S REALLY INTERESTING TO THINK 228 00:09:47,400 --> 00:09:50,800 ABOUT GOING BACK TO 2008, 2009, 229 00:09:50,800 --> 00:09:54,280 WHEN WE STARTED THE IPREX TRIAL, 230 00:09:54,280 --> 00:09:57,480 THINKING ABOUT WHAT A RISK 231 00:09:57,480 --> 00:10:01,080 PEOPLE THOUGHT THAT WAS. 232 00:10:01,080 --> 00:10:05,680 HERE WE ARE NOW 15, 18 YEARS 233 00:10:05,680 --> 00:10:07,560 LATER, IT HAS GRADE A FROM 234 00:10:07,560 --> 00:10:09,160 PREVENTIVE SERVICES TASK FORCE. 235 00:10:09,160 --> 00:10:16,960 CONTRAST THAT TO WHAT IS SEEN 236 00:10:16,960 --> 00:10:19,560 WITH INJECTABLE CAV WHERE THE 237 00:10:19,560 --> 00:10:20,960 TIME HAS SHRUNK, A FANTASTIC 238 00:10:20,960 --> 00:10:21,960 PLACE TO BE. 239 00:10:21,960 --> 00:10:23,280 WE LOOK FORWARD TO OPPORTUNITIES 240 00:10:23,280 --> 00:10:24,520 BECAUSE CHOICE IS WHAT THIS IS 241 00:10:24,520 --> 00:10:24,840 ABOUT. 242 00:10:24,840 --> 00:10:26,480 IT WOULD BE GOOD TO HAVE 243 00:10:26,480 --> 00:10:28,160 ADDITIONAL CHOICES THAT HAVE A 244 00:10:28,160 --> 00:10:31,840 GRADE A, THAT WOULD BE ALLOWED 245 00:10:31,840 --> 00:10:37,880 FOR PEOPLE AT RISK OF ACQUIRING 246 00:10:37,880 --> 00:10:38,440 HIV. 247 00:10:38,440 --> 00:10:44,000 SEPTEMBER 1, THE FINDINGS FROM 248 00:10:44,000 --> 00:10:54,560 THE AC TIV-2/AIDS TRIALS, EIGHT 249 00:10:57,200 --> 00:11:04,640 MANUSCRIPTS INCLUDED, A TOUR DU 250 00:11:04,640 --> 00:11:11,080 FORCE, CONGRATULATIONS TO THE 251 00:11:11,080 --> 00:11:12,680 ACTIV-2 TEAM, IN THE DIVISION, 252 00:11:12,680 --> 00:11:13,760 ACTG AND SITES. 253 00:11:13,760 --> 00:11:17,120 I ENCOURAGE YOU TO LOOK AT THIS 254 00:11:17,120 --> 00:11:20,200 BECAUSE WE'RE NOT DONE WITH 255 00:11:20,200 --> 00:11:24,440 THERAPEUTICS IN COVID, BY ANY 256 00:11:24,440 --> 00:11:24,640 MEANS. 257 00:11:24,640 --> 00:11:28,960 NOW I GET TO MOVE THROUGH TWO 258 00:11:28,960 --> 00:11:31,360 CONCEPTS FOR APPROVAL. 259 00:11:31,360 --> 00:11:32,320 I'LL EXPLAIN WHY. 260 00:11:32,320 --> 00:11:36,480 ONE OF THE AREAS THAT WE'RE 261 00:11:36,480 --> 00:11:40,800 TRYING TO ADJUST IS HOW WE 262 00:11:40,800 --> 00:11:43,280 ADVANCE THE RESEARCH THAT IS 263 00:11:43,280 --> 00:11:44,520 DONE THROUGH CERTAIN PROGRAMS IN 264 00:11:44,520 --> 00:11:45,480 THE DIVISION. 265 00:11:45,480 --> 00:11:48,240 ONE OF THE PROGRAMS THAT IS 266 00:11:48,240 --> 00:11:49,880 CONGRESSIONALLY MANDATED WAS THE 267 00:11:49,880 --> 00:11:52,720 ENDING THE HIV EPIDEMIC, AND THE 268 00:11:52,720 --> 00:11:53,920 FUNDING HAD BEEN GIVEN TO THE 269 00:11:53,920 --> 00:11:56,360 DIVISION ON A YEARLY BASIS, AND 270 00:11:56,360 --> 00:11:58,960 WE WERE GIVEN INSTRUCTIONS THAT 271 00:11:58,960 --> 00:12:01,920 THOSE FUNDS WERE TO MOVE THROUGH 272 00:12:01,920 --> 00:12:04,320 THE CENTERS PROGRAMS OF THE 273 00:12:04,320 --> 00:12:06,880 DIVISION OF AIDS, THE NIH, THE 274 00:12:06,880 --> 00:12:09,440 CFARs AND THROUGH THE AHRQ 275 00:12:09,440 --> 00:12:10,760 PROGRAMS OF NIMH. 276 00:12:10,760 --> 00:12:15,240 AND SINCE 2018 TILL NOW, WE HAVE 277 00:12:15,240 --> 00:12:16,560 MOVED THAT MONEY AT $26 MILLION 278 00:12:16,560 --> 00:12:19,960 A YEAR THROUGH THOSE VEHICLES, 279 00:12:19,960 --> 00:12:26,320 AND IT HAS CREATED A LOT OF 280 00:12:26,320 --> 00:12:28,720 WORK FOR THE GRANTEES IN TERMS 281 00:12:28,720 --> 00:12:31,000 OF WRITING SUPPLEMENT REQUESTS, 282 00:12:31,000 --> 00:12:34,720 OR DIVISION STAFF FOR REVIEW 283 00:12:34,720 --> 00:12:36,800 PURPOSES, AS WELL AS THE GRANTS 284 00:12:36,800 --> 00:12:39,200 MANAGEMENT PEOPLE TO PUT THESE 285 00:12:39,200 --> 00:12:40,520 TOGETHER AND GET THEM FUNDED. 286 00:12:40,520 --> 00:12:43,600 SO WHAT WE'RE DOING THROUGH THIS 287 00:12:43,600 --> 00:12:45,880 NOSI IS TO CHANGE HOW WE'RE 288 00:12:45,880 --> 00:12:47,960 SOLICITING THIS RESEARCH FOR THE 289 00:12:47,960 --> 00:12:50,480 IMPLEMENTATION SCIENCE TO 290 00:12:50,480 --> 00:12:53,080 ADDRESS THE GOALS OF HHS ENDING 291 00:12:53,080 --> 00:12:54,480 THE EPIDEMIC. 292 00:12:54,480 --> 00:13:01,480 WE'RE GOING TO MOVE TO A 293 00:13:01,480 --> 00:13:02,800 SOLICITATION FOR R01s, R21s, 294 00:13:02,800 --> 00:13:03,480 R34s THAT WILL ALLOW 295 00:13:03,480 --> 00:13:08,160 INVESTIGATORS THAT ARE WORKING 296 00:13:08,160 --> 00:13:10,160 WITHIN A SPECIFIC JURISDICTION, 297 00:13:10,160 --> 00:13:12,560 ALL LAID OUT, ADDRESSING 298 00:13:12,560 --> 00:13:15,520 PRINCIPLES OF EHE TO APPLY FOR 299 00:13:15,520 --> 00:13:18,440 FUNDING TO TAKE WHAT WE'VE 300 00:13:18,440 --> 00:13:19,640 LEARNED FROM ALL OF THESE 301 00:13:19,640 --> 00:13:21,840 HUNDREDS OF SUPPLEMENTS THAT WE 302 00:13:21,840 --> 00:13:24,480 HAVE FUNDED AND PUT THIS INTO 303 00:13:24,480 --> 00:13:25,320 MAYBE SOME MULTI-YEAR PROJECTS 304 00:13:25,320 --> 00:13:30,080 WHERE WE CAN REALLY LOOK AT 305 00:13:30,080 --> 00:13:31,720 IMPLEMENTATION WITH OUR PARTNERS 306 00:13:31,720 --> 00:13:33,560 AT CDC AND HRSA, TAKING THE WORK 307 00:13:33,560 --> 00:13:37,200 WE'VE SUPPORTED TO THE NEXT STEP 308 00:13:37,200 --> 00:13:40,160 BY TAKING THIS ACTION. 309 00:13:40,160 --> 00:13:44,240 THIS IS A NECESSARY PROCESS TO 310 00:13:44,240 --> 00:13:47,600 HELP TO PUT THIS MONEY IN A 311 00:13:47,600 --> 00:13:48,240 DIFFERENT FORM, DIFFERENT 312 00:13:48,240 --> 00:13:52,640 PLACES, WHERE IT CAN TRULY HAVE 313 00:13:52,640 --> 00:13:56,360 GREATER IMPACT THAN THE YEARLY 314 00:13:56,360 --> 00:13:56,880 SUPPLEMENTS, STOP-START, 315 00:13:56,880 --> 00:14:00,200 STOP-START, TRYING TO BUILD A 316 00:14:00,200 --> 00:14:01,720 SUPER HIGHWAY FOR RESEARCH AND 317 00:14:01,720 --> 00:14:02,920 IMPLEMENTATION SCIENCE THAT 318 00:14:02,920 --> 00:14:04,560 WE'RE SUPPORTING UNDER THIS 319 00:14:04,560 --> 00:14:08,720 PROGRAM BY PUBLISHING THIS NOSI. 320 00:14:08,720 --> 00:14:09,720 THE PARTNERSHIPS OF THE GROUPS 321 00:14:09,720 --> 00:14:10,720 OF THE INSTITUTES THAT ARE 322 00:14:10,720 --> 00:14:13,360 ALREADY PART OF THE CFAR PROGRAM 323 00:14:13,360 --> 00:14:14,400 ARE AN ESSENTIAL PART. 324 00:14:14,400 --> 00:14:18,920 YOU SEE THAT'S WHY ALL THOSE 325 00:14:18,920 --> 00:14:20,560 INSTITUTES OAR ARE LISTED WE 326 00:14:20,560 --> 00:14:21,400 LOW. 327 00:14:21,400 --> 00:14:23,040 I'VE EXPLAINED THIS BACKGROUND 328 00:14:23,040 --> 00:14:23,560 ALREADY. 329 00:14:23,560 --> 00:14:26,440 SO THE BOTTOM LINE IS 330 00:14:26,440 --> 00:14:29,320 COLLECTIVELY WE FUNDED OVER 400 331 00:14:29,320 --> 00:14:33,600 COMMUNITY-BASED ORGANIZATIONS, 332 00:14:33,600 --> 00:14:35,520 ACADEMIC INSTITUTIONS, HEALTH 333 00:14:35,520 --> 00:14:36,160 DEPARTMENTS. 334 00:14:36,160 --> 00:14:37,320 AND LOCAL BUSINESSES TO CONDUCT 335 00:14:37,320 --> 00:14:38,160 THIS RESEARCH. 336 00:14:38,160 --> 00:14:39,720 IT'S REALLY NOW TIME TO TAKE THE 337 00:14:39,720 --> 00:14:45,440 BEST OF THIS WORK AND APPLY IT 338 00:14:45,440 --> 00:14:47,440 IN A MORE JUDICIOUS WAY. 339 00:14:47,440 --> 00:14:50,160 AGAIN, IN TERMS OF PRIORITY 340 00:14:50,160 --> 00:14:54,000 TOPIC AREAS, WE WANT TO IMPROVE 341 00:14:54,000 --> 00:14:56,800 ENGAGEMENT AND REENGAGEMENT FOR 342 00:14:56,800 --> 00:14:58,960 TESTING, TREATMENT, CARE 343 00:14:58,960 --> 00:14:59,280 SERVICES. 344 00:14:59,280 --> 00:15:02,120 AND THIS STUDY CAN FOCUS ON 345 00:15:02,120 --> 00:15:04,480 PEOPLE EXPERIENCING UNSTABLE 346 00:15:04,480 --> 00:15:06,400 HOUSING OR HOMELESSNESS, WITHIN 347 00:15:06,400 --> 00:15:08,240 COMMUNITIES AFFECTED BY CLUSTERS 348 00:15:08,240 --> 00:15:10,960 AND OUTBREAKS AS WELL AS SCALE 349 00:15:10,960 --> 00:15:12,840 UP STRATEGIES TO DELIVER 350 00:15:12,840 --> 00:15:14,040 PREVENTION AND TREATMENT 351 00:15:14,040 --> 00:15:15,320 SERVICES TO ADDRESS 352 00:15:15,320 --> 00:15:16,000 COMORBIDITIES AND CO-INFECTIONS. 353 00:15:16,000 --> 00:15:19,520 ALL OF THIS IS DONE IN 354 00:15:19,520 --> 00:15:21,000 PARTNERSHIP WITH THE 355 00:15:21,000 --> 00:15:22,240 COMMUNITY-BASED ORGANIZATION, 356 00:15:22,240 --> 00:15:25,400 AND WITHIN THE CONCEPT OF 357 00:15:25,400 --> 00:15:28,680 WORKING WITH HRSA OR CDC 358 00:15:28,680 --> 00:15:30,480 PARTNERS WITHIN ONE OF THE 359 00:15:30,480 --> 00:15:32,000 JURISDICTIONS AT THIS POINT. 360 00:15:32,000 --> 00:15:38,480 SO THAT'S THE PURPOSE OF THIS 361 00:15:38,480 --> 00:15:38,800 SPECIFIC NOSI. 362 00:15:38,800 --> 00:15:41,960 I'LL TAKE QUESTIONS ON THIS, AND 363 00:15:41,960 --> 00:15:45,280 THEN I KNOW I'M RUNNING LATE. 364 00:15:45,280 --> 00:15:47,320 SO IF THERE ARE ANY QUESTIONS, 365 00:15:47,320 --> 00:15:48,880 I'LL TAKE THEM. 366 00:15:48,880 --> 00:15:52,360 IF YOU WOULD VOTE ON THIS 367 00:15:52,360 --> 00:15:53,760 CONCEPT IN THE ECB, IN THE 368 00:15:53,760 --> 00:15:56,120 MEANTIME. 369 00:15:56,120 --> 00:16:02,200 370 00:16:02,200 --> 00:16:08,800 371 00:16:08,800 --> 00:16:12,080 AS WE WERE GOING THROUGH AND 372 00:16:12,080 --> 00:16:13,640 PUTTING TOGETHER THE INITIATIVE 373 00:16:13,640 --> 00:16:15,520 I JUST DISCUSSED, WE REALIZED 374 00:16:15,520 --> 00:16:19,200 THAT WE DID NOT HAVE A SIMPLE 375 00:16:19,200 --> 00:16:21,600 MECHANISM FOR TAKING IN THESE 376 00:16:21,600 --> 00:16:23,360 SIMILAR KINDS OF SUPPLEMENT 377 00:16:23,360 --> 00:16:25,880 REQUESTS FOR THE CFARs 378 00:16:25,880 --> 00:16:26,440 PROGRAM. 379 00:16:26,440 --> 00:16:28,960 SO THIS INITIATIVE IS TO CREATE 380 00:16:28,960 --> 00:16:32,120 COMPETING REVISIONS TO THE 381 00:16:32,120 --> 00:16:35,760 EXISTING CFAR GRANTS AS WELL AS 382 00:16:35,760 --> 00:16:39,440 DEVELOPMENTAL CFARs TO ALLOW 383 00:16:39,440 --> 00:16:41,720 THEM TO APPLY FOR, THROUGH THIS 384 00:16:41,720 --> 00:16:43,480 METHOD, TO TAKE PROGRAMS THAT 385 00:16:43,480 --> 00:16:46,000 THEY HAVE BEEN -- WE'VE BEEN 386 00:16:46,000 --> 00:16:48,000 FUNDING, SUPPLEMENTS YEAR BY 387 00:16:48,000 --> 00:16:50,720 YEAR BY YEAR, TO ESSENTIALLY 388 00:16:50,720 --> 00:16:55,640 COMPETE FOR THOSE AND PUT THEM 389 00:16:55,640 --> 00:16:57,200 IN THE PARENT GRANT, A 390 00:16:57,200 --> 00:16:58,360 STREAMLINING EXERCISE TO TAKE 391 00:16:58,360 --> 00:17:00,120 EXISTING PROGRAMS THAT WE'VE 392 00:17:00,120 --> 00:17:02,960 BEEN COMPETING FOR THE CFARs 393 00:17:02,960 --> 00:17:05,440 ON A YEARLY BASIS AND LITERALLY 394 00:17:05,440 --> 00:17:09,640 BUNDLE THEM AND THEN PUT THEM 395 00:17:09,640 --> 00:17:11,280 WITHIN THE PARENT AWARD. 396 00:17:11,280 --> 00:17:13,800 THIS WILL STREAMLINE THE WORK 397 00:17:13,800 --> 00:17:15,840 FOR THE CFARs, FOR PROGRAM 398 00:17:15,840 --> 00:17:16,760 STAFF, AND FOR GRANTS 399 00:17:16,760 --> 00:17:17,080 MANAGEMENT. 400 00:17:17,080 --> 00:17:19,600 SO THAT'S WHY YOU SEE 20 AWARDS 401 00:17:19,600 --> 00:17:20,800 HERE, BECAUSE THERE ARE 20 402 00:17:20,800 --> 00:17:24,080 CFARs, AND THE HOPE IS THAT 403 00:17:24,080 --> 00:17:25,160 ULTIMATELY EVERY CFAR WILL 404 00:17:25,160 --> 00:17:26,160 CHOOSE TO APPLY. 405 00:17:26,160 --> 00:17:27,280 IT'S IN THEIR BEST INTEREST 406 00:17:27,280 --> 00:17:29,440 BECAUSE WE'RE NOT GOING TO HAVE 407 00:17:29,440 --> 00:17:31,840 THESE SUPPLEMENTS ANYMORE, AS WE 408 00:17:31,840 --> 00:17:32,360 GO FORWARD. 409 00:17:32,360 --> 00:17:34,160 THE TIMES OF PROGRAMS WE'RE 410 00:17:34,160 --> 00:17:36,400 GOING TO PUT INTO THIS ARE 411 00:17:36,400 --> 00:17:38,000 PROGRAMS THAT ARE REALLY 412 00:17:38,000 --> 00:17:43,640 IMPORTANT TO THE DIVISION AND 413 00:17:43,640 --> 00:17:46,160 THE GRANTEES, ADELANTE LOOKS AT 414 00:17:46,160 --> 00:17:49,040 PROGRAMS FOR HEALTH DISPARITIES 415 00:17:49,040 --> 00:17:50,880 AMONG HISPANIC AND LATINX 416 00:17:50,880 --> 00:17:55,480 POPULATIONS, ONE OF MY FAVORITE 417 00:17:55,480 --> 00:17:57,960 PROGRAMS IS THE CDEIPI PROGRAM, 418 00:17:57,960 --> 00:18:00,920 TAKING HIGH SCHOOL UNDERGRADUATE 419 00:18:00,920 --> 00:18:02,680 AND GRADUATE STUDENTS, 420 00:18:02,680 --> 00:18:04,200 POSTDOCTORAL FELLOWS, BRINGING 421 00:18:04,200 --> 00:18:14,040 THEM TO OTHER INSTITUTIONS TO 422 00:18:14,040 --> 00:18:15,800 EXPAND HORIZONS. 423 00:18:15,800 --> 00:18:17,640 AFRICUE TO RECRUIT, MENTOR, 424 00:18:17,640 --> 00:18:19,840 SUPPORT EARLY AND MID-CAREER 425 00:18:19,840 --> 00:18:22,600 MENTORS FROM AFRICA TO BECOME 426 00:18:22,600 --> 00:18:28,720 INDEPENDENT SCIENTISTS PURSUING 427 00:18:28,720 --> 00:18:30,360 HIV CURE RESEARCH. 428 00:18:30,360 --> 00:18:32,120 WE REALLY NEED THESE TO BE BUILT 429 00:18:32,120 --> 00:18:33,320 IN A MULTI-YEAR WAY, IF I COULD 430 00:18:33,320 --> 00:18:37,720 ASK YOU TO VOTE FOR THIS IN THE 431 00:18:37,720 --> 00:18:46,600 ECB, I WOULD APPRECIATE THAT. 432 00:18:46,600 --> 00:18:49,440 ANY QUESTIONS ON EITHER OF THESE 433 00:18:49,440 --> 00:18:50,400 WHILE YOU'RE VOTING? 434 00:18:50,400 --> 00:18:50,640 AUDREY? 435 00:18:50,640 --> 00:18:54,640 >> I'LL SAY IT'S IMPORTANT, OUR 436 00:18:54,640 --> 00:18:57,920 UNC CFAR, I HAD A STUDENT FROM 437 00:18:57,920 --> 00:18:59,680 NC CENTRAL WORK WITH ME LAST 438 00:18:59,680 --> 00:19:01,880 YEAR WHO WAS ACCEPTED TO ONE OF 439 00:19:01,880 --> 00:19:03,840 THE NIH SUMMER TRAINING PROGRAMS 440 00:19:03,840 --> 00:19:05,280 AFTER THAT, AND SHE'S PLANNING 441 00:19:05,280 --> 00:19:07,320 TO GO TO GRAD SCHOOL. 442 00:19:07,320 --> 00:19:14,560 YEAH, I THINK IT'S REALLY A 443 00:19:14,560 --> 00:19:15,600 GREAT PROGRAM. 444 00:19:15,600 --> 00:19:16,920 >> MONICA? 445 00:19:16,920 --> 00:19:20,280 >> I AGREE, CDEIPI IS AMAZING. 446 00:19:20,280 --> 00:19:20,880 NO MORE ADMINISTRATIVE 447 00:19:20,880 --> 00:19:22,000 SUPPLEMENTS WOULD SAY MAYBE YOU 448 00:19:22,000 --> 00:19:23,440 WANT MORE EQUIPMENT OR WE'RE 449 00:19:23,440 --> 00:19:25,400 GOING TO FOCUS ON THIS? 450 00:19:25,400 --> 00:19:27,240 >> WE WON'T HAVE THESE RECURRING 451 00:19:27,240 --> 00:19:32,680 SUPPLEMENTS BUT THESE ARE 452 00:19:32,680 --> 00:19:32,920 RECURRING. 453 00:19:32,920 --> 00:19:42,760 EVERY YEAR WE ASK FOR AN 454 00:19:42,760 --> 00:19:43,160 ADELANTE OR CDEIPI. 455 00:19:43,160 --> 00:19:43,480 >> PERFECT. 456 00:19:43,480 --> 00:19:45,360 >> THERE WILL BE OTHER PROGRAMS 457 00:19:45,360 --> 00:19:47,640 THAT ARE ANNUAL, THOSE WERE JUST 458 00:19:47,640 --> 00:19:49,600 LISTED AS EXAMPLES. 459 00:19:49,600 --> 00:19:52,240 BUT YES, IF YOUR FREEZER BREAKS 460 00:19:52,240 --> 00:19:59,440 WE'LL STILL BE ABLE TO HELP YOU. 461 00:19:59,440 --> 00:20:02,200 AND TO REMIND YOU THE NEXT 462 00:20:02,200 --> 00:20:04,920 COUNCIL MEETING WILL BE VIRTUAL 463 00:20:04,920 --> 00:20:07,680 ON TUESDAY, THE 30th OF 464 00:20:07,680 --> 00:20:09,680 JANUARY, NOT JANUARY 29th, AND 465 00:20:09,680 --> 00:20:10,960 OTHER DATES FOR UPCOMING 466 00:20:10,960 --> 00:20:12,080 MEETINGS ARE LISTED THERE. 467 00:20:12,080 --> 00:20:16,960 THAT'S IT FOR ME. 468 00:20:16,960 --> 00:20:24,600 ANY ADDITIONAL QUESTIONS FOR ME? 469 00:20:24,600 --> 00:20:28,520 MELISSA? 470 00:20:28,520 --> 00:20:35,920 >> PRE-EXPOSURE PROPHYLAXIS, 471 00:20:35,920 --> 00:20:38,000 TRUVADA, LONG ACTING CAB, I'M 472 00:20:38,000 --> 00:20:39,400 HERE TO REMEMBER COMMUNITY, 473 00:20:39,400 --> 00:20:44,720 COMMUNITY PARTNERSHIPS, COMMUNIT 474 00:20:44,720 --> 00:20:45,760 ADVOCACY, ENGAGEMENT, WORLDWIDE 475 00:20:45,760 --> 00:20:50,160 THERE'S CONCERN ABOUT ACCESS TO 476 00:20:50,160 --> 00:20:51,920 CAB-LA. 477 00:20:51,920 --> 00:20:54,120 I RECOGNIZE WE'RE RESEARCH 478 00:20:54,120 --> 00:20:55,160 INITIATIVE, WE DELIVER RESULTS, 479 00:20:55,160 --> 00:20:57,800 BUT WHAT IS THE ROLE OR WHOSE 480 00:20:57,800 --> 00:21:01,200 JOB IS IT TO ADDRESS SOME OF 481 00:21:01,200 --> 00:21:02,720 THESE BARRIERS THAT WE'RE 482 00:21:02,720 --> 00:21:03,840 EXPERIENCING WORLDWIDE FOR 483 00:21:03,840 --> 00:21:06,680 PEOPLE TO HAVE ACCESS TO THE 484 00:21:06,680 --> 00:21:08,040 CHOICE THAT YOU DESCRIBE? 485 00:21:08,040 --> 00:21:10,880 IN TERMS OF THE PROBLEMS AND 486 00:21:10,880 --> 00:21:12,880 CHALLENGES WITH PURCHASE 487 00:21:12,880 --> 00:21:14,480 AGREEMENTS, DRUG PRICING, OTHER 488 00:21:14,480 --> 00:21:15,880 NEGOTIATIONS, AGAIN I RECOGNIZE 489 00:21:15,880 --> 00:21:19,080 THIS IS A RESEARCH ENDEAVOR THAT 490 00:21:19,080 --> 00:21:20,160 WE'RE HERE FOR. 491 00:21:20,160 --> 00:21:23,680 BUT, YOU KNOW, WE CONDUCT 492 00:21:23,680 --> 00:21:26,960 RESEARCH TO CREATE THIS CHOICE, 493 00:21:26,960 --> 00:21:29,560 CREATE OPPORTUNITIES FOR PEOPLE 494 00:21:29,560 --> 00:21:30,800 TO HAVE THE BEST RESOURCES 495 00:21:30,800 --> 00:21:33,320 AVAILABLE THAT THEY NEED TO 496 00:21:33,320 --> 00:21:34,000 PROTECT THEMSELVES. 497 00:21:34,000 --> 00:21:37,480 AND, AGAIN, I KNOW THIS IS 498 00:21:37,480 --> 00:21:40,520 OUTSIDE OUR DIRECT PURVIEW, BUT 499 00:21:40,520 --> 00:21:42,480 BECAUSE WE HAVE DELIVERED THIS 500 00:21:42,480 --> 00:21:45,360 RESULT, IT TOOK SO MUCH EFFORT 501 00:21:45,360 --> 00:21:46,920 THROUGH SYSTEMS AND NETWORKS AND 502 00:21:46,920 --> 00:21:49,920 COMMUNITY AND SITES, ET CETERA, 503 00:21:49,920 --> 00:21:51,680 EVEN PUSHING THROUGH A PANDEMIC 504 00:21:51,680 --> 00:21:55,160 THAT COULD HAVE DERAILED THAT 505 00:21:55,160 --> 00:21:56,200 STUDY, PEOPLE HAVE DEEPLY 506 00:21:56,200 --> 00:21:57,600 INVESTED IN IT AND IT'S A 507 00:21:57,600 --> 00:22:03,200 STRUGGLE THAT WE DON'T HAVE THE 508 00:22:03,200 --> 00:22:04,920 ACCESS THAT WAS EXPECTED. 509 00:22:04,920 --> 00:22:06,880 IF YOU COULD SHARE WHOSE JOB OR 510 00:22:06,880 --> 00:22:09,200 WHOSE ROLE OR WHAT MORE CAN BE 511 00:22:09,200 --> 00:22:10,640 DONE, IF ANYTHING, AND TO 512 00:22:10,640 --> 00:22:14,120 COMMUNICATE THESE CONCERNS TO 513 00:22:14,120 --> 00:22:16,520 THE LEADERSHIP AS IT'S 514 00:22:16,520 --> 00:22:16,880 TRANSITIONING. 515 00:22:16,880 --> 00:22:17,720 >> LEADERSHIP UP AND DOWN THE 516 00:22:17,720 --> 00:22:19,280 CHAIN IS VERY AWARE OF CONCERNS 517 00:22:19,280 --> 00:22:22,000 AND ISSUES THAT WE'RE FACING. 518 00:22:22,000 --> 00:22:24,520 I THINK THE FIRST BIGGEST 519 00:22:24,520 --> 00:22:26,600 CHALLENGE IS YOU'RE GETTING 520 00:22:26,600 --> 00:22:28,040 ENOUGH OF THE PRODUCT 521 00:22:28,040 --> 00:22:31,120 MANUFACTURED, SO THAT IT IS 522 00:22:31,120 --> 00:22:32,080 AVAILABLE, IN-COUNTRY APPROVAL, 523 00:22:32,080 --> 00:22:34,920 WORK WITH PARTNERS SUCH AS 524 00:22:34,920 --> 00:22:36,760 PEPFAR, CLINTON HEALTH 525 00:22:36,760 --> 00:22:39,080 INITIATIVE, AND OTHER GROUPS 526 00:22:39,080 --> 00:22:41,800 THAT HAVE DONE SUPERB JOB ON 527 00:22:41,800 --> 00:22:42,720 CONTROLLING PRICING FOR 528 00:22:42,720 --> 00:22:44,880 ANTI-RETRO VIRALS. 529 00:22:44,880 --> 00:22:47,400 NIH HAS NO VEHICLE OR HANDLE 530 00:22:47,400 --> 00:22:51,800 OTHER THAN OUR ABILITY TO LOBBY 531 00:22:51,800 --> 00:22:56,280 AND BE PART OF CONVERSATIONS TO 532 00:22:56,280 --> 00:22:57,480 HELP AFFECT THOSE KINDS OF 533 00:22:57,480 --> 00:23:03,960 THINGS BUT JUST CONTINUE TO 534 00:23:03,960 --> 00:23:04,200 ADVOCATE. 535 00:23:04,200 --> 00:23:04,600 >> THANK YOU. 536 00:23:04,600 --> 00:23:06,560 THANK YOU FOR BRINGING UP THAT 537 00:23:06,560 --> 00:23:07,760 CRITICAL ISSUE. 538 00:23:07,760 --> 00:23:09,320 I WANT TO REMIND EVERYBODY 539 00:23:09,320 --> 00:23:11,400 PLEASE INTRODUCE YOURSELF WHEN 540 00:23:11,400 --> 00:23:13,800 YOU'RE SPEAKING, FOR THE FOLKS 541 00:23:13,800 --> 00:23:14,480 ON ZOOM. 542 00:23:14,480 --> 00:23:18,200 AND NOW ASK THE OFFICE OF AIDS 543 00:23:18,200 --> 00:23:19,720 RESEARCH TO COME UP AND GIVE 544 00:23:19,720 --> 00:23:20,600 THEIR REPORT. 545 00:23:20,600 --> 00:23:22,120 I GATHER IT'S A TAG TEAM. 546 00:23:22,120 --> 00:23:24,280 IS IT A TAG TEAM PRESENTATION? 547 00:23:24,280 --> 00:23:24,480 >> YES. 548 00:23:24,480 --> 00:23:26,840 >> IF YOU COULD EACH INTRODUCE 549 00:23:26,840 --> 00:23:28,880 YOURSELF AS YOU SPEAK. 550 00:23:28,880 --> 00:23:30,560 >> THANK YOU. 551 00:23:30,560 --> 00:23:34,920 I'M DR. PAUL GAIST, NIH OFFICE 552 00:23:34,920 --> 00:23:36,920 OF AIDS RESEARCH. 553 00:23:36,920 --> 00:23:39,560 IS THIS BETTER? 554 00:23:39,560 --> 00:23:41,840 BETTER, BETTER? 555 00:23:41,840 --> 00:23:42,080 OKAY. 556 00:23:42,080 --> 00:23:43,560 THANK YOU. 557 00:23:43,560 --> 00:23:46,000 PAUL GAIST, NIH OFFICE OF AIDS 558 00:23:46,000 --> 00:23:47,440 RESEARCH, SENIOR SCIENCE 559 00:23:47,440 --> 00:23:47,680 ADVISER. 560 00:23:47,680 --> 00:23:49,760 AND MY COLLEAGUES WILL INTRODUCE 561 00:23:49,760 --> 00:23:54,000 THEMSELVES AS THEY COME TO THE 562 00:23:54,000 --> 00:23:54,680 PODIUM. 563 00:23:54,680 --> 00:23:57,160 OUR PRESENTATION TODAY ACTUALLY 564 00:23:57,160 --> 00:24:02,640 IS A NICE SEGUE AND ROLL-THROUGH 565 00:24:02,640 --> 00:24:04,120 FROM WHAT DR. DIEFFENBACH WAS 566 00:24:04,120 --> 00:24:06,240 JUST SAYING ABOUT BRINGING 567 00:24:06,240 --> 00:24:07,320 PEOPLE TOGETHER, CONCENTRATING 568 00:24:07,320 --> 00:24:08,760 RESOURCES, THINKING HOW OUR 569 00:24:08,760 --> 00:24:12,040 RESEARCH CAN APPLY TO EHE AND 570 00:24:12,040 --> 00:24:13,880 OTHER TYPES OF PROGRAMS. 571 00:24:13,880 --> 00:24:15,560 WE APPRECIATE THE OPPORTUNITY TO 572 00:24:15,560 --> 00:24:17,280 PRESENT TO YOU TODAY. 573 00:24:17,280 --> 00:24:19,240 BEGINNING WITH DISCUSSIONS 574 00:24:19,240 --> 00:24:22,080 BETWEEN THE FORMER NIH OFFICE OF 575 00:24:22,080 --> 00:24:23,080 AIDS RESEARCH DIRECTOR MAUREEN 576 00:24:23,080 --> 00:24:26,720 GOODENOW AND DIRECTOR OF NIMH'S 577 00:24:26,720 --> 00:24:27,840 DIVISION OF AIDS RESEARCH DIANNE 578 00:24:27,840 --> 00:24:29,360 RAUSCH, A CORE PLANNING GROUP 579 00:24:29,360 --> 00:24:35,280 WAS CHARGED WITH INCREASING AND 580 00:24:35,280 --> 00:24:37,520 EVOLVING NIH'S ACTIVITIES, IN 581 00:24:37,520 --> 00:24:39,320 THE HIV AND PHARMACY SPACE. 582 00:24:39,320 --> 00:24:42,120 THIS AREA OF INTEREST WAS THEN 583 00:24:42,120 --> 00:24:51,760 SUPPORTED AND AMPLIFIED BY BILL 584 00:24:51,760 --> 00:24:52,280 CAPPAGIANIS. 585 00:24:52,280 --> 00:24:53,720 TODAY WE'LL FOCUS ON ORGANIZED 586 00:24:53,720 --> 00:24:55,480 MEETING HELD AT THE END OF JUNE, 587 00:24:55,480 --> 00:24:57,880 KEY PART OF THE LARGER 588 00:24:57,880 --> 00:25:00,080 CONTINUING EFFORT AT NIH TO 589 00:25:00,080 --> 00:25:01,200 EXPLORE AND EXPAND RESEARCH AND 590 00:25:01,200 --> 00:25:08,160 OPPORTUNITIES IN THIS SPACE. 591 00:25:08,160 --> 00:25:09,280 NEXT SLIDE PLEASE. 592 00:25:09,280 --> 00:25:11,680 A CORE PLANNING GROUP WAS 593 00:25:11,680 --> 00:25:13,320 ASSEMBLED WHICH THEN RECEIVED A 594 00:25:13,320 --> 00:25:15,720 GREAT RESPONSE WHEN WE FORMED 595 00:25:15,720 --> 00:25:17,840 THE NIH HIV AND PHARMACY 596 00:25:17,840 --> 00:25:18,480 PLANNING GROUP. 597 00:25:18,480 --> 00:25:21,080 TO DATE AS YOU SEE THERE'S A 598 00:25:21,080 --> 00:25:23,240 TOTAL OF TEN NIH ICOS 599 00:25:23,240 --> 00:25:24,600 PARTICIPATING, AND WE WOULD LIKE 600 00:25:24,600 --> 00:25:33,000 TO POINT OUT AND THANK OUR NIAID 601 00:25:33,000 --> 00:25:34,320 REPRESENTATIVES AND TAKE THE 602 00:25:34,320 --> 00:25:36,720 OPPORTUNITY TO RECOGNIZE TODAY'S 603 00:25:36,720 --> 00:25:39,960 MEETING HERE, THE NIH OFFICE OF 604 00:25:39,960 --> 00:25:42,200 AIDS RESEARCH ADVISORY COUNCIL 605 00:25:42,200 --> 00:25:49,840 MEMBER DR. ANN KNEELEN, THE 606 00:25:49,840 --> 00:25:50,760 LIAISON. 607 00:25:50,760 --> 00:25:53,160 THIS WAS THE LOGO AND TITLE OF 608 00:25:53,160 --> 00:25:55,200 THE MEETING HELD VIRTUALLY OVER 609 00:25:55,200 --> 00:25:58,800 TWO DAYS ON JUNE 28 AND 29 WITH 610 00:25:58,800 --> 00:26:02,000 OVER 300 PARTICIPANTS, OVER 40 611 00:26:02,000 --> 00:26:02,400 SPEAKERS. 612 00:26:02,400 --> 00:26:03,320 SPEAKERS AND ATTENDEES 613 00:26:03,320 --> 00:26:04,720 REPRESENTED A DIVERSE SWATH FROM 614 00:26:04,720 --> 00:26:07,880 ACROSS THE U.S. GOVERNMENT, 615 00:26:07,880 --> 00:26:09,000 COMMUNITY, ACADEMIC, BUSINESS 616 00:26:09,000 --> 00:26:09,760 SECTORS. 617 00:26:09,760 --> 00:26:10,880 SPEAKERS AND OTHER MEETING 618 00:26:10,880 --> 00:26:12,480 PARTICIPANTS WERE SELECTED BY 619 00:26:12,480 --> 00:26:14,120 THE PLANNING GROUP, SPECIFICALLY 620 00:26:14,120 --> 00:26:15,000 FOR THEIR INVOLVEMENT AND 621 00:26:15,000 --> 00:26:20,040 EXPERIENCE IN THE AREAS OF HIV, 622 00:26:20,040 --> 00:26:21,920 PHARMACY SPACE, IN MOST CASES 623 00:26:21,920 --> 00:26:22,760 BOTH. 624 00:26:22,760 --> 00:26:23,760 NEXT SLIDE PLEASE. 625 00:26:23,760 --> 00:26:25,080 THE OVERALL STRUCTURE AND 626 00:26:25,080 --> 00:26:26,600 SESSIONS OF MEETING ARE 627 00:26:26,600 --> 00:26:27,960 REPRESENTED ON THIS SLIDE. 628 00:26:27,960 --> 00:26:30,000 BEGINNING WITH A STAGE SETTING 629 00:26:30,000 --> 00:26:31,760 OPENING PLENARY FOLLOWED BY 630 00:26:31,760 --> 00:26:33,520 FOCUS ON COMMUNITY INTERESTS, 631 00:26:33,520 --> 00:26:35,240 MEETING WAS ORGANIZED BY THE 632 00:26:35,240 --> 00:26:37,680 FOUR APPROACHES LISTED HERE AND 633 00:26:37,680 --> 00:26:39,640 A PANEL PRESENTATION DISCUSSION 634 00:26:39,640 --> 00:26:41,040 FORMAT FOR EACH. 635 00:26:41,040 --> 00:26:43,120 CLOSING SESSION INCLUDING 636 00:26:43,120 --> 00:26:47,280 MEETING SUMMARY REPORT-OUT BY 637 00:26:47,280 --> 00:26:48,680 DR. EL-NAHAL. 638 00:26:48,680 --> 00:26:50,720 I TURN THE PODIUM OVER TO HIM TO 639 00:26:50,720 --> 00:26:55,280 PROVIDE MORE DETAIL ABOUT 640 00:26:55,280 --> 00:26:57,040 DISCUSSIONS AND OUTCOMES WHICH 641 00:26:57,040 --> 00:26:59,200 WE'VE UPDATED FOR THE PURPOSES 642 00:26:59,200 --> 00:27:02,400 OF YOUR MEETING TODAY. 643 00:27:02,400 --> 00:27:02,800 DR. EL-NAHAL? 644 00:27:02,800 --> 00:27:08,200 >> THANK YOU, PAUL. 645 00:27:08,200 --> 00:27:11,160 HI. 646 00:27:11,160 --> 00:27:12,480 I'M WALID EL-NAHAL, AAAS FELLOW, 647 00:27:12,480 --> 00:27:18,720 NIH OFFICE OF AIDS RESEARCH, AND 648 00:27:18,720 --> 00:27:20,400 I SERVED AT THIS MEETING IN 649 00:27:20,400 --> 00:27:20,600 JUNE. 650 00:27:20,600 --> 00:27:22,480 I'LL TAKE YOU THROUGH THE 651 00:27:22,480 --> 00:27:28,280 HIGHLIGHTS AND SUMMARIZE KEY 652 00:27:28,280 --> 00:27:30,560 TAKEWAYS, FIRST AN OUTLINE. 653 00:27:30,560 --> 00:27:32,600 I'M GOING TO TALK ABOUT 654 00:27:32,600 --> 00:27:33,960 POTENTIAL OF PHARMACIES TO 655 00:27:33,960 --> 00:27:35,920 PROVIDE HIV SERVICES, A KEY 656 00:27:35,920 --> 00:27:37,560 COMPONENT OF LOTS OF TALKS THAT 657 00:27:37,560 --> 00:27:39,960 HAPPENED AT THIS MEETING. 658 00:27:39,960 --> 00:27:43,120 I'LL GO OVER EXIST MOMENTUM 659 00:27:43,120 --> 00:27:45,000 WHICH IS DEMONSTRATED AT THE 660 00:27:45,000 --> 00:27:47,480 MEETING FROM JUST A VERY LARGE 661 00:27:47,480 --> 00:27:48,600 GROUP OF DIVERSE INTERESTED 662 00:27:48,600 --> 00:27:51,680 PARTIES FROM ALL SORTS OF 663 00:27:51,680 --> 00:27:51,880 SECTORS. 664 00:27:51,880 --> 00:27:53,680 I'M GOING TO BRIEFLY SAMPLE SOME 665 00:27:53,680 --> 00:27:54,280 CURRENT RESEARCH LANDSCAPE WE 666 00:27:54,280 --> 00:27:56,720 HEARD ABOUT AT THE MEETING IN 667 00:27:56,720 --> 00:27:58,480 JUNE, AND I'LL TRANSITION INTO 668 00:27:58,480 --> 00:28:03,000 TALKING ABOUT BARRIERS TO HIV 669 00:28:03,000 --> 00:28:04,320 SERVICES DELIVERED IN PHARMACIES 670 00:28:04,320 --> 00:28:06,280 AND PIVOT TO WE'VE TALKED ABOUT 671 00:28:06,280 --> 00:28:07,920 BARRIERS, WHAT THEN IS THE NEED 672 00:28:07,920 --> 00:28:09,240 FOR FUTURE RESEARCH TO TRY AND 673 00:28:09,240 --> 00:28:10,800 ADDRESS SOME OF THOSE BARRIERS 674 00:28:10,800 --> 00:28:13,040 AND LASTLY I'LL HAND IT OVER TO 675 00:28:13,040 --> 00:28:15,360 MIKE TO TALK ABOUT SOME 676 00:28:15,360 --> 00:28:22,600 OPPORTUNITIES MOVING FORWARD IN 677 00:28:22,600 --> 00:28:23,800 THIS INITIATIVE. 678 00:28:23,800 --> 00:28:25,640 FIRST, FROM THE MEETING IN JOIN, 679 00:28:25,640 --> 00:28:26,640 I'LL OPEN TALKING ABOUT 680 00:28:26,640 --> 00:28:28,920 POTENTIAL OF PHARMACIES TO 681 00:28:28,920 --> 00:28:30,440 PROVIDE HIV SERVICES, SUMMARIZED 682 00:28:30,440 --> 00:28:31,320 IN THIS WORD CLOUD GENERATED ON 683 00:28:31,320 --> 00:28:34,320 THE DAY OF THE MEETING BY 684 00:28:34,320 --> 00:28:35,000 PARTICIPANTS THEMSELVES, WHEN 685 00:28:35,000 --> 00:28:36,800 ASKED ABOUT KIND OF WHY YOU 686 00:28:36,800 --> 00:28:39,440 THINK PHARMACIES HAVE VALUE AS 687 00:28:39,440 --> 00:28:41,400 AVENUE FOR DELIVERING HIV 688 00:28:41,400 --> 00:28:43,280 SERVICES, THESE WERE SOME WORDS. 689 00:28:43,280 --> 00:28:46,640 I'LL HONE IN ON THE BIGGEST 690 00:28:46,640 --> 00:28:49,200 WORD, IN THE CENTER, ACCESS 691 00:28:49,200 --> 00:28:50,680 WHICH REALLY SUMMARIZES THIS 692 00:28:50,680 --> 00:28:50,880 WELL. 693 00:28:50,880 --> 00:28:52,440 AND, AGAIN, LOTS OF SPEAKERS ON 694 00:28:52,440 --> 00:28:54,080 THE DAY OF MEETING TALKED ABOUT 695 00:28:54,080 --> 00:28:54,720 THAT. 696 00:28:54,720 --> 00:28:56,400 THE REASON WE BELIEVE PHARMACIES 697 00:28:56,400 --> 00:28:59,040 ARE AN OPPORTUNITY TO INCREASE 698 00:28:59,040 --> 00:29:00,560 ACCESS IS BECAUSE THERE'S 60,000 699 00:29:00,560 --> 00:29:02,200 PHARMACIES ACROSS THE UNITED 700 00:29:02,200 --> 00:29:04,120 STATES, 90% OF THE U.S. 701 00:29:04,120 --> 00:29:05,120 POPULATION LIVES WITHIN FIVE 702 00:29:05,120 --> 00:29:07,960 MILES OF THE COMMUNITY PHARMACY. 703 00:29:07,960 --> 00:29:09,320 THIS MAP WAS PRESENTED AND 704 00:29:09,320 --> 00:29:10,840 RECENTLY PUBLISHED AT THE 705 00:29:10,840 --> 00:29:13,560 MEETING IN JUNE. 706 00:29:13,560 --> 00:29:15,200 BASICALLY DEMONSTRATES THE BLUE 707 00:29:15,200 --> 00:29:18,040 DOTS ON THE MAP DEMONSTRATE THE 708 00:29:18,040 --> 00:29:18,920 SIGNIFICANT NUMBER OF PHARMACIES 709 00:29:18,920 --> 00:29:20,400 AVAILABLE AND HOW THEY ARE 710 00:29:20,400 --> 00:29:23,640 WIDELY SPREAD ACROSS THE MAP, 711 00:29:23,640 --> 00:29:26,160 COMPARED TO SOME TRADITIONAL 712 00:29:26,160 --> 00:29:28,360 YELLOW TRIANGLES, PrEP 713 00:29:28,360 --> 00:29:29,640 PRESCRIBING LOCATIONS, 714 00:29:29,640 --> 00:29:31,080 PHARMACIES FAR OUTNUMBER OTHER 715 00:29:31,080 --> 00:29:32,520 AVENUES THROUGH WHICH WE'VE 716 00:29:32,520 --> 00:29:35,480 DELIVERED CARE. 717 00:29:35,480 --> 00:29:41,280 NOT JUST DOMESTICALLY, LEFT IS 718 00:29:41,280 --> 00:29:44,680 ATLANTA, RIGHT IS SUB-SAHARAN 719 00:29:44,680 --> 00:29:45,600 AFRICA. 720 00:29:45,600 --> 00:29:47,160 WE HEARD FROM SPEAKERS THERE ARE 721 00:29:47,160 --> 00:29:49,280 THOUSANDS OF PHARMACIES IN 722 00:29:49,280 --> 00:29:50,480 UNDERSERVED AREAS PRESENTING 723 00:29:50,480 --> 00:29:51,880 OPPORTUNITY TO MITIGATE SOME 724 00:29:51,880 --> 00:29:53,840 HEALTH DISPARITIES WE'VE BECOME 725 00:29:53,840 --> 00:29:54,760 FAMILIAR WITH. 726 00:29:54,760 --> 00:29:58,040 THEY ALSO AS A RESULT PRESENT AN 727 00:29:58,040 --> 00:29:59,000 OPPORTUNITY TO ADDRESS 728 00:29:59,000 --> 00:30:00,200 INEQUITIES, PHARMACIES ARE OPEN 729 00:30:00,200 --> 00:30:01,800 LONG HOURS AND ACCESSIBLE AT 730 00:30:01,800 --> 00:30:02,600 CONVENIENT HOURS. 731 00:30:02,600 --> 00:30:04,480 THEY CAN BE COST EFFECTIVE. 732 00:30:04,480 --> 00:30:06,320 ONE OF THE SPEAKERS MENTIONED 733 00:30:06,320 --> 00:30:08,280 THAT FOR EACH DOLLAR SPENT ON 734 00:30:08,280 --> 00:30:09,840 CARE DELIVERED THROUGH 735 00:30:09,840 --> 00:30:11,000 PHARMACIES WE COULD POTENTIALLY 736 00:30:11,000 --> 00:30:13,760 SAVE $3 ON THE BACK END FOR HIV 737 00:30:13,760 --> 00:30:15,920 DIAGNOSIS, TREATMENT, AND CARE. 738 00:30:15,920 --> 00:30:16,840 THERE'S ALSO OBVIOUSLY LESSONS 739 00:30:16,840 --> 00:30:18,040 LEARNED FROM THE COVID-19 740 00:30:18,040 --> 00:30:18,360 PANDEMIC. 741 00:30:18,360 --> 00:30:20,440 WE'RE ALL FAMILIAR WITH THE IDEA 742 00:30:20,440 --> 00:30:22,320 THAT PHARMACIES WERE A HUGE 743 00:30:22,320 --> 00:30:24,280 SOURCE OF DELIVERING CARE DURING 744 00:30:24,280 --> 00:30:25,480 THE PANDEMIC THROUGH DELIVERY OF 745 00:30:25,480 --> 00:30:26,800 MILLIONS AND MILLIONS OF 746 00:30:26,800 --> 00:30:28,200 VACCINATIONS, AS WELL AS 747 00:30:28,200 --> 00:30:29,080 MILLIONS OF TESTS. 748 00:30:29,080 --> 00:30:30,840 WE WANT TO TAKE THOSE 749 00:30:30,840 --> 00:30:32,160 OPPORTUNITIES AND LEARN FROM 750 00:30:32,160 --> 00:30:33,680 THEM AS RELATES TO HIV WHICH 751 00:30:33,680 --> 00:30:34,960 WAS, AGAIN, A FOCUS OF SOME OF 752 00:30:34,960 --> 00:30:37,480 THE TALKS AT THE MEETING. 753 00:30:37,480 --> 00:30:39,160 SO, THAT WAS JUST A BRIEF 754 00:30:39,160 --> 00:30:42,400 OVERVIEW OF HOW SOME PRESENTERS 755 00:30:42,400 --> 00:30:43,680 TALKED ABOUT WHY THERE'S SO MUCH 756 00:30:43,680 --> 00:30:44,880 POTENTIAL IN THIS SPACE. 757 00:30:44,880 --> 00:30:47,120 WHAT I WANT TO DO NEXT IS 758 00:30:47,120 --> 00:30:49,120 DEMONSTRATE AMOUNT OF MOMENTUM 759 00:30:49,120 --> 00:30:51,080 THERE IS FOR PHARMACY-BASED HIV 760 00:30:51,080 --> 00:30:52,800 SERVICES, CAPTURED BY THE FACT 761 00:30:52,800 --> 00:30:55,560 THERE WERE SO MANY FOLKS FROM 762 00:30:55,560 --> 00:30:56,560 VARIOUS SECTORS TALKING ABOUT 763 00:30:56,560 --> 00:30:59,400 THIS WORK AND DOING WORK IN THIS 764 00:30:59,400 --> 00:30:59,600 AREA. 765 00:30:59,600 --> 00:31:01,240 ONE NOTED 15 STATES AUTHORIZED 766 00:31:01,240 --> 00:31:07,480 PHARMACIST PRESCRIPTION OF 767 00:31:07,480 --> 00:31:08,800 PrEP AND PEP, INCLUDED IN THE 768 00:31:08,800 --> 00:31:09,600 NATIONAL STRATEGY WHICH HAROLD 769 00:31:09,600 --> 00:31:11,000 SPOKE ABOUT AT THE MEETING. 770 00:31:11,000 --> 00:31:11,960 U.S. PUBLIC HEALTH SERVICES WAS 771 00:31:11,960 --> 00:31:14,520 AT THE MEETING AND SPOKE ABOUT 772 00:31:14,520 --> 00:31:15,600 EHE PHARMACY TASK FORCE. 773 00:31:15,600 --> 00:31:17,680 WE HEARD DURING THE MEETING IN 774 00:31:17,680 --> 00:31:23,920 JUNIPER SPECK ACTIVES OF 775 00:31:23,920 --> 00:31:26,760 ADVOCATES, THE COALITION HOSTED 776 00:31:26,760 --> 00:31:28,720 A ROUNDTABLE AND IN ATTENDANCE 777 00:31:28,720 --> 00:31:30,000 AS WELL. 778 00:31:30,000 --> 00:31:36,040 AND WE SAW PRESENTED THIS 779 00:31:36,040 --> 00:31:38,240 GROWING LITERATURE ON PHARMACIES 780 00:31:38,240 --> 00:31:39,760 FOR HIV CARE, CULMINATING IN THE 781 00:31:39,760 --> 00:31:41,440 MEETING IN JUNE TO SUMMARIZE THE 782 00:31:41,440 --> 00:31:41,720 RESEARCH. 783 00:31:41,720 --> 00:31:44,120 THE TAKEAWAY FROM THE LAST SLIDE 784 00:31:44,120 --> 00:31:46,200 IS THAT WE HAVE FOLKS FROM 785 00:31:46,200 --> 00:31:47,520 FEDERAL GOVERNMENT, STATE 786 00:31:47,520 --> 00:31:48,440 GOVERNMENT, ACADEMIA, INDUSTRY, 787 00:31:48,440 --> 00:31:49,600 THE COMMUNITY ALL VERY INVESTED 788 00:31:49,600 --> 00:31:51,240 IN THIS WORK AND WORKING TO TRY 789 00:31:51,240 --> 00:31:52,240 AND ADVANCE IT. 790 00:31:52,240 --> 00:31:53,960 SO THE NEXT THING I'LL DO IS GO 791 00:31:53,960 --> 00:31:55,920 OVER SOME OF THE CURRENT 792 00:31:55,920 --> 00:31:57,400 RESEARCH LANDSCAPE, THIS IS NOT 793 00:31:57,400 --> 00:31:59,040 MEANT TO BE COMPREHENSIVE. 794 00:31:59,040 --> 00:32:00,440 IT'S REALLY JUST THE SAMPLING WE 795 00:32:00,440 --> 00:32:02,160 GOT AT THE MEETING FROM THE 796 00:32:02,160 --> 00:32:03,960 VARIOUS PRESENTERS WHO SPOKE ON 797 00:32:03,960 --> 00:32:04,800 TOPICS OF RESEARCH AND THE WORK 798 00:32:04,800 --> 00:32:07,880 THEY ARE DOING IN THIS AREA. 799 00:32:07,880 --> 00:32:09,960 SO DURING THE MEETING IN JUNE WE 800 00:32:09,960 --> 00:32:13,440 GOT TO SEE QUALITATIVE DATA THAT 801 00:32:13,440 --> 00:32:15,520 DEMONSTRATED INTEREST FROM 802 00:32:15,520 --> 00:32:16,480 PATIENTS, WILLINGNESS FROM 803 00:32:16,480 --> 00:32:18,280 PHARMACISTS TO PROVIDE SERVICES. 804 00:32:18,280 --> 00:32:20,480 WE SAW PILOTS, MULTI-CENTER 805 00:32:20,480 --> 00:32:21,320 STUDIES DEMONSTRATING SUCCESSFUL 806 00:32:21,320 --> 00:32:22,520 TESTING OF HUNDREDS OF 807 00:32:22,520 --> 00:32:24,160 PARTICIPANTS FOR HIV, INCLUDING 808 00:32:24,160 --> 00:32:26,360 SOME POPULATIONS THAT REALLY 809 00:32:26,360 --> 00:32:27,080 HISTORICALLY ARE UNDERTESTED, 810 00:32:27,080 --> 00:32:28,320 WHICH MEANS COULD SUGGEST IT'S A 811 00:32:28,320 --> 00:32:30,160 GREAT WAY TO REACH NEWER 812 00:32:30,160 --> 00:32:30,760 POPULATIONS. 813 00:32:30,760 --> 00:32:32,720 WE SAW EXAMPLES OF 814 00:32:32,720 --> 00:32:34,160 COLLABORATIONS BETWEEN ACADEMIA, 815 00:32:34,160 --> 00:32:35,640 COMMUNITY AND RETAIL PHARMACIES, 816 00:32:35,640 --> 00:32:39,280 OVER A RANGE OF DIFFERENT 817 00:32:39,280 --> 00:32:40,480 HIV-RELATED SERVICES AND 818 00:32:40,480 --> 00:32:41,440 PROGRAMS. 819 00:32:41,440 --> 00:32:43,840 WE SAW GREAT EXAMPLES OF 820 00:32:43,840 --> 00:32:45,720 PHARMACIES BEING LEVERAGED AS A 821 00:32:45,720 --> 00:32:46,280 MEANS DELIVERING PrEP, 822 00:32:46,280 --> 00:32:51,720 SPEAKING TO THE POINT RAISED 823 00:32:51,720 --> 00:32:53,280 EARLIER, CORNER PHARMACY 824 00:32:53,280 --> 00:32:56,080 OFFERING COUNSELING, TESTING, 825 00:32:56,080 --> 00:32:56,440 PRESCRIPTION. 826 00:32:56,440 --> 00:32:57,640 WE SAW MULTI-DISCIPLINARY WORK 827 00:32:57,640 --> 00:32:59,840 WITH TEAMS INCLUDING NURSE 828 00:32:59,840 --> 00:33:01,360 NAVIGATORS, PHARMACISTS, REMOTE 829 00:33:01,360 --> 00:33:03,120 PHYSICIANS TO INCREASE PrEP 830 00:33:03,120 --> 00:33:03,320 ACCESS. 831 00:33:03,320 --> 00:33:05,520 IN RURAL COMMUNITIES WE SAW 832 00:33:05,520 --> 00:33:06,960 EXAMPLE OF TELEPrEP STUDIES TO 833 00:33:06,960 --> 00:33:08,200 EXTEND REACH AND COVERAGE OF 834 00:33:08,200 --> 00:33:12,320 PrEP TO FOLKS WE HAVEN'T 835 00:33:12,320 --> 00:33:13,720 HISTORICALLY ENGAGED WELL 836 00:33:13,720 --> 00:33:14,240 OTHERWISE. 837 00:33:14,240 --> 00:33:15,600 WE ALSO SAW INVESTIGATIONS OF 838 00:33:15,600 --> 00:33:17,040 PHARMACIES AS AVENUE FOR 839 00:33:17,040 --> 00:33:17,680 LONG-ACTING THERAPY FOR HIV 840 00:33:17,680 --> 00:33:19,640 WHICH AGAIN TO THE POINT BROUGHT 841 00:33:19,640 --> 00:33:21,080 UP EARLIER WE KNOW HAS BEEN A 842 00:33:21,080 --> 00:33:23,600 CHALLENGE FOR LOTS OF CLINICS TO 843 00:33:23,600 --> 00:33:25,480 ADMINISTER AND PATIENTS TO 844 00:33:25,480 --> 00:33:25,920 ACCESS. 845 00:33:25,920 --> 00:33:28,080 WE SAW TRAINING PROGRAMS FOR 846 00:33:28,080 --> 00:33:29,520 PHARMACISTS IN MEDICATION 847 00:33:29,520 --> 00:33:30,840 MANAGEMENT TO INCREASE 848 00:33:30,840 --> 00:33:31,920 PROPORTION OF VIRALLY SUPPRESSED 849 00:33:31,920 --> 00:33:33,120 PEOPLE LIVING WITH HIV. 850 00:33:33,120 --> 00:33:35,880 AND WE SAW PROGRAMS FROM LARGE 851 00:33:35,880 --> 00:33:41,120 RETAIL PHARMACIES IN ADDITION 852 00:33:41,120 --> 00:33:42,440 SMALLER COMMUNITY PHARMACIES, 853 00:33:42,440 --> 00:33:44,280 THAT SOUNDED LIKE IT WAS 854 00:33:44,280 --> 00:33:47,000 DOMESTIC BUT WE SAW GREAT WORK 855 00:33:47,000 --> 00:33:48,440 INTERNATIONALLY, AGAIN PILOTS 856 00:33:48,440 --> 00:33:51,400 AND TRIALS OF DRUG DISPENSING 857 00:33:51,400 --> 00:33:53,240 OUTLETS TO FACILITATE 858 00:33:53,240 --> 00:33:58,080 SELF-TESTING AMONG YOUNG WOMEN 859 00:33:58,080 --> 00:34:00,520 IN TANZANIA AND PrEP DELIVERY 860 00:34:00,520 --> 00:34:01,800 PATHWAYS IN KENYA. 861 00:34:01,800 --> 00:34:03,240 THAT WAS A WHIRLWIND AND I 862 00:34:03,240 --> 00:34:05,160 COVERED A LOT OF STUDIES AND 863 00:34:05,160 --> 00:34:06,520 LISTED WAYS PHARMACIES HAVE BEEN 864 00:34:06,520 --> 00:34:08,440 USED TO DELIVER CARE BUT THE BIG 865 00:34:08,440 --> 00:34:09,880 PICTURE TAKEAWAY FROM THE MANY 866 00:34:09,880 --> 00:34:12,360 PRESENTATIONS WE HAD DURING THE 867 00:34:12,360 --> 00:34:13,720 MEETING WAS THAT WHEN YOU'RE 868 00:34:13,720 --> 00:34:15,480 THINKING ABOUT THIS SPACE OF HIV 869 00:34:15,480 --> 00:34:19,080 AND PHARMACY AS A MEANS OF 870 00:34:19,080 --> 00:34:19,960 DELIVERING SERVICES THERE'S 871 00:34:19,960 --> 00:34:22,680 RESEARCH DESIGNED DIVERSITY, WE 872 00:34:22,680 --> 00:34:25,440 SAW TRIALS, PILOTS, QUALITATIVE 873 00:34:25,440 --> 00:34:26,840 RESEARCH, OBSERVATIONAL STUDIES, 874 00:34:26,840 --> 00:34:28,280 OUTCOME DIVERSITY, FOLKS LOOKING 875 00:34:28,280 --> 00:34:30,800 AT TREATMENT, LOOKING AT PrEP, 876 00:34:30,800 --> 00:34:32,080 LOOKING AT COMORBIDITIES, TARGET 877 00:34:32,080 --> 00:34:33,080 POPULATION AND GEOGRAPHIC 878 00:34:33,080 --> 00:34:35,480 DIVERSITY AS I MENTIONED, WORK 879 00:34:35,480 --> 00:34:38,120 BEING DONE DOMESTICALLY AND 880 00:34:38,120 --> 00:34:38,720 INTERNATIONALLY. 881 00:34:38,720 --> 00:34:40,320 AND THANKFULLY THERE'S A BROAD 882 00:34:40,320 --> 00:34:41,640 RANGE OF COLLABORATORS FROM 883 00:34:41,640 --> 00:34:42,920 ACADEMIA TO COMMUNITY TO HEALTH 884 00:34:42,920 --> 00:34:44,360 DEPARTMENTS SO A LOT OF INTEREST 885 00:34:44,360 --> 00:34:48,200 AND A LOT OF ENGAGEMENT. 886 00:34:48,200 --> 00:34:49,480 THE BIG SUMMARY WAS THAT THERE'S 887 00:34:49,480 --> 00:34:52,680 A GROWING BODY OF DATA THAT 888 00:34:52,680 --> 00:34:53,360 SUGGESTS PHARMACY-BASED HIV 889 00:34:53,360 --> 00:34:56,520 SERVICE DELIVERY IS OF INTEREST 890 00:34:56,520 --> 00:34:58,240 TO PATIENTS, HIGHLY FEASIBLE, 891 00:34:58,240 --> 00:35:00,040 IT'S EFFECTIVE FOR REACHING 892 00:35:00,040 --> 00:35:02,320 HIGHER PROPORTION OF THE 893 00:35:02,320 --> 00:35:04,400 POPULATION, COST AND TIME 894 00:35:04,400 --> 00:35:07,680 EFFECTIVE, COULD BE USED TO 895 00:35:07,680 --> 00:35:09,760 MITIGATE STIGMA AND CAN INCLUDE 896 00:35:09,760 --> 00:35:10,960 PREVENTION, DIAGNOSIS, 897 00:35:10,960 --> 00:35:12,280 TREATMENT, AND OTHER SERVICES 898 00:35:12,280 --> 00:35:13,560 THAT ARE GAINING INCREASED 899 00:35:13,560 --> 00:35:15,520 ATTENTION LIKE MANAGEMENT OF 900 00:35:15,520 --> 00:35:17,440 COMORBIDITIES FOR PEOPLE LIVING 901 00:35:17,440 --> 00:35:17,760 WITH HIV. 902 00:35:17,760 --> 00:35:19,960 I TALKED ABOUT THE WORK THAT'S 903 00:35:19,960 --> 00:35:21,720 BEEN DONE, SOME SUCCESSES WE'VE 904 00:35:21,720 --> 00:35:23,320 SEEN IN THIS SPACE. 905 00:35:23,320 --> 00:35:25,840 THROUGHOUT THE MEETING WE ALSO 906 00:35:25,840 --> 00:35:27,800 HEARD VARIOUS BARRIERS TO 907 00:35:27,800 --> 00:35:28,800 DELIVERING HIV CARE IN 908 00:35:28,800 --> 00:35:29,200 PHARMACIES. 909 00:35:29,200 --> 00:35:32,720 LOTS OF THESE WERE THREADED 910 00:35:32,720 --> 00:35:33,400 THROUGHOUT PRESENTATIONS, I'LL 911 00:35:33,400 --> 00:35:36,440 LIST THEM THAT CAME UP 912 00:35:36,440 --> 00:35:37,120 REPEATEDLY? 913 00:35:37,120 --> 00:35:37,320 JUNE. 914 00:35:37,320 --> 00:35:38,760 TALK OF ISSUES OF SCOPE OF 915 00:35:38,760 --> 00:35:40,440 PRACTICE WHICH VARIES FROM STATE 916 00:35:40,440 --> 00:35:42,280 TO STATE FOR PHARMACISTS. 917 00:35:42,280 --> 00:35:44,360 ISSUES RELATED TO WORKFORCE 918 00:35:44,360 --> 00:35:44,840 TRAINING. 919 00:35:44,840 --> 00:35:46,720 ISSUES OF SCALABILITY AND 920 00:35:46,720 --> 00:35:47,920 SUSTAINABILITY OF INTERVENTIONS. 921 00:35:47,920 --> 00:35:50,680 ISSUES RELATED TO REIMBURSEMENT 922 00:35:50,680 --> 00:35:51,000 FOR SERVICES. 923 00:35:51,000 --> 00:35:52,640 ISSUE OF PHARMACY DESERTS, I 924 00:35:52,640 --> 00:35:54,320 MENTIONED PHARMACIES ARE WIDELY 925 00:35:54,320 --> 00:35:56,040 AVAILABLE BUT NOT EVERYWHERE, OF 926 00:35:56,040 --> 00:35:56,520 COURSE. 927 00:35:56,520 --> 00:36:04,160 WE HEARD ABOUT BARRIERS TO 928 00:36:04,160 --> 00:36:06,240 IMPLEMENTING BARRIERS TO TEGS ON 929 00:36:06,240 --> 00:36:07,440 SITES, PROMOTING HEALTHY 930 00:36:07,440 --> 00:36:11,480 BEHAVIORS, LINKAGE TO CARE, 931 00:36:11,480 --> 00:36:12,160 WORKFLOW INTEGRATION, PHARMACIST 932 00:36:12,160 --> 00:36:13,760 BANDWIDTH, A LONG LIST OF 933 00:36:13,760 --> 00:36:15,440 BARRIERS, SO YOU WOULD TAKE EACH 934 00:36:15,440 --> 00:36:17,920 OF THOSE AND THINK IF YOU'RE 935 00:36:17,920 --> 00:36:18,520 LOOKING FROM RESEARCH 936 00:36:18,520 --> 00:36:20,240 PERSPECTIVE HOW DO I TURN A 937 00:36:20,240 --> 00:36:21,440 BARRIER INTO A RESEARCH QUESTION 938 00:36:21,440 --> 00:36:23,640 THAT IF WE ADDRESS ALLOWS US TO 939 00:36:23,640 --> 00:36:25,200 OVERCOME THAT BARRIER, SO WE DID 940 00:36:25,200 --> 00:36:28,360 THAT EXERCISE AT THE END OF THE 941 00:36:28,360 --> 00:36:30,560 MEETING AND I'LL GO THROUGH THAT 942 00:36:30,560 --> 00:36:31,800 AND LIST EACH BARRIER AND 943 00:36:31,800 --> 00:36:33,400 BRIEFLY THINK OF THE BIG PICTURE 944 00:36:33,400 --> 00:36:35,480 RESEARCH QUESTIONS THAT WOULD BE 945 00:36:35,480 --> 00:36:37,560 ASSOCIATED WITH THAT IF WE 946 00:36:37,560 --> 00:36:39,280 ADDRESSED COULD POTENTIALLY 947 00:36:39,280 --> 00:36:39,960 SURMOUNT SOME OBSTACLES TO 948 00:36:39,960 --> 00:36:42,040 DELIVERING CARE THIS WAY. 949 00:36:42,040 --> 00:36:43,240 STARTING WITH IMPLEMENTATION, 950 00:36:43,240 --> 00:36:45,320 HOW DO YOU BEST IMPLEMENT 951 00:36:45,320 --> 00:36:45,960 PHARMACY-BASED INTERVENTIONS AND 952 00:36:45,960 --> 00:36:49,400 THINK ABOUT THE FACT THE CONTEXT 953 00:36:49,400 --> 00:36:51,040 DIFFERS FROM WALMART OR 954 00:36:51,040 --> 00:36:53,040 WALGREEN'S TO A SMALL COMMUNITY 955 00:36:53,040 --> 00:36:55,000 PHARMACY, THEY HAVE DIFFERENT 956 00:36:55,000 --> 00:36:57,160 LEVELS OF RESOURCES, DIFFERENT 957 00:36:57,160 --> 00:36:58,120 STAFFING, DIFFERENT COMMUNITIES 958 00:36:58,120 --> 00:36:59,680 THEY SERVE SO THAT CONTEXT IS 959 00:36:59,680 --> 00:37:02,600 IMPORTANT AND HOW DOES 960 00:37:02,600 --> 00:37:03,040 IMPLEMENTATION VARY. 961 00:37:03,040 --> 00:37:04,560 TESTING, HOW DO YOU THINK ABOUT 962 00:37:04,560 --> 00:37:06,120 NEWER TECHNOLOGIES AND MAKE SURE 963 00:37:06,120 --> 00:37:08,200 WE'RE MAKING IT AS EASY AS 964 00:37:08,200 --> 00:37:10,400 POSSIBLE TO TEST ON SITE AND 965 00:37:10,400 --> 00:37:11,400 BETTER LEVERAGE TESTING 966 00:37:11,400 --> 00:37:12,360 TECHNOLOGIES WE ALREADY HAVE. 967 00:37:12,360 --> 00:37:14,560 WHEN IT COMES TO PROMOTING 968 00:37:14,560 --> 00:37:15,840 HEALTHY BEHAVIORS, HOW CAN WE 969 00:37:15,840 --> 00:37:18,280 USE BEHAVIORAL AND SOCIAL 970 00:37:18,280 --> 00:37:19,160 SCIENCE TO SUPPORT 971 00:37:19,160 --> 00:37:20,160 PHARMACY-BASED INTERVENTION, 972 00:37:20,160 --> 00:37:21,000 MAKE SURE THESE INTERVENTIONS 973 00:37:21,000 --> 00:37:24,080 ARE BEING DONE IN A WAY THAT 974 00:37:24,080 --> 00:37:25,520 CENTERS POPULATION WE'RE 975 00:37:25,520 --> 00:37:27,320 INTERESTED IN PROVIDING CARE FOR 976 00:37:27,320 --> 00:37:29,440 AND ENGAGES THEM AS PARTNERS TO 977 00:37:29,440 --> 00:37:30,960 MAKE SURE IT'S COMMUNITY DRIVEN 978 00:37:30,960 --> 00:37:33,480 AND ADDRESSING THEIR NEEDS, NOT 979 00:37:33,480 --> 00:37:35,240 ONLY ACCEPTABLE BUT ENTICING TO 980 00:37:35,240 --> 00:37:36,000 USE THESE SERVICES. 981 00:37:36,000 --> 00:37:38,080 NEXT IS THE ISSUE OF LINKAGE TO 982 00:37:38,080 --> 00:37:38,320 CARE. 983 00:37:38,320 --> 00:37:39,960 WHAT'S THE BEST WAY TO MAKE SURE 984 00:37:39,960 --> 00:37:41,920 THE CARE ISN'T JUST STOPPING AT 985 00:37:41,920 --> 00:37:43,320 DING OR DIAGNOSIS BUT WE'RE 986 00:37:43,320 --> 00:37:45,080 LINKING SOMEONE TO CARE TO 987 00:37:45,080 --> 00:37:46,840 CONTINUE TO GET TREATMENT, SO 988 00:37:46,840 --> 00:37:48,680 HOW DO YOU BUILD PARTNERSHIPS 989 00:37:48,680 --> 00:37:49,800 BETWEEN PHARMACIES AND HEALTH 990 00:37:49,800 --> 00:37:50,760 DEPARTMENTS OR THE CLINICS THAT 991 00:37:50,760 --> 00:37:52,440 ARE GOING TO BE PROVIDING 992 00:37:52,440 --> 00:37:54,280 LONG-TERM CARE FOR FOLKS? 993 00:37:54,280 --> 00:37:59,080 WORKFLOW INTEGRATION, A LOT OF 994 00:37:59,080 --> 00:38:00,600 SERVICES ARE ALREADY OFFERED. 995 00:38:00,600 --> 00:38:02,280 IF THIS ISN'T DONE EFFICIENTLY 996 00:38:02,280 --> 00:38:03,720 IT WILL OVERWHELM THE FOLKS 997 00:38:03,720 --> 00:38:08,400 INVOLVED WHICH BRINGS ME TO THE 998 00:38:08,400 --> 00:38:13,120 LAST POINT OF PHARMACIST 999 00:38:13,120 --> 00:38:14,600 BANDWIDTH, SUPPORTING THE 1000 00:38:14,600 --> 00:38:16,800 PHARMACISTS DOING THIS WORK. 1001 00:38:16,800 --> 00:38:18,040 REMAINING, FIRST SCOPE OF 1002 00:38:18,040 --> 00:38:18,760 PRACTICE, A COMPLICATED QUESTION 1003 00:38:18,760 --> 00:38:20,560 THAT CAME UP MULTIPLE TIMES. 1004 00:38:20,560 --> 00:38:22,320 THE SCOPE OF PRACTICE VARIES 1005 00:38:22,320 --> 00:38:24,080 ACROSS STATE TO STATE. 1006 00:38:24,080 --> 00:38:26,000 AGAIN WITHOUT ADVOCATING FOR ANY 1007 00:38:26,000 --> 00:38:27,120 POLICIES AS A FEDERAL GOVERNMENT 1008 00:38:27,120 --> 00:38:28,880 EMPLOYEE I'M GOING TO MENTION 1009 00:38:28,880 --> 00:38:32,920 THIS TOPIC OF WHAT POLICIES CAN 1010 00:38:32,920 --> 00:38:41,440 FACILITATE THAT WORK NEEDS TO BE 1011 00:38:41,440 --> 00:38:42,200 LOOKED@. 1012 00:38:42,200 --> 00:38:44,520 AND WHAT IS SCOPE OF 1013 00:38:44,520 --> 00:38:46,040 PHARMACISTS, JUST FOCUSED ON 1014 00:38:46,040 --> 00:38:48,000 VIRAL SUPPRESSION OR THINGS LIKE 1015 00:38:48,000 --> 00:38:49,440 COMORBIDITIES, MANAGEMENT OF 1016 00:38:49,440 --> 00:38:54,040 MENTAL HEALTH, OF SUBSTANCE USE 1017 00:38:54,040 --> 00:39:02,680 DISORDER AND HOW CAN WE LEVERAGE 1018 00:39:02,680 --> 00:39:03,560 THEM. 1019 00:39:03,560 --> 00:39:05,200 HOW DO WE TRAIN A TEAM? 1020 00:39:05,200 --> 00:39:06,880 AND THE ISSUE THAT PHARMACIES 1021 00:39:06,880 --> 00:39:08,280 ARE DIFFERENT ACROSS THE COUNTRY 1022 00:39:08,280 --> 00:39:09,720 IN AMOUNT OF RESOURCES THAT ARE 1023 00:39:09,720 --> 00:39:12,560 DIFFERENT, HOW DO WE SCALE 1024 00:39:12,560 --> 00:39:14,880 ACROSS LOCAL CONTEXTS. 1025 00:39:14,880 --> 00:39:16,600 THE NEXT POINT IS ISSUE OF 1026 00:39:16,600 --> 00:39:17,720 REIMBURSEMENT WHICH CAME UP OVER 1027 00:39:17,720 --> 00:39:19,800 AND OVER, WHAT IS COST 1028 00:39:19,800 --> 00:39:20,480 EFFECTIVENESS OF DELIVERING 1029 00:39:20,480 --> 00:39:22,080 INTERVENTION THIS WAY AND HOW 1030 00:39:22,080 --> 00:39:24,160 DOES THAT TIE TO REIMBURSEMENT. 1031 00:39:24,160 --> 00:39:25,840 THE POINT MADE IF THESE SERVICES 1032 00:39:25,840 --> 00:39:27,560 ARE NOT REIMBURSED IT'S GOING TO 1033 00:39:27,560 --> 00:39:33,240 BE DIFFICULT TO SUSTAIN THEM. 1034 00:39:33,240 --> 00:39:34,040 PHARMACIES ARE GEOGRAPHICALLY 1035 00:39:34,040 --> 00:39:35,520 WIDELY PRESENT BUT THERE IS THE 1036 00:39:35,520 --> 00:39:37,800 ISSUE THAT NOT EVERY PLACE HAS A 1037 00:39:37,800 --> 00:39:38,720 CLOSE ACCESS TO PHARMACY EVEN 1038 00:39:38,720 --> 00:39:40,240 THOUGH A LOT DO. 1039 00:39:40,240 --> 00:39:41,520 THAT'S JUST ONE DIMENSION OF THE 1040 00:39:41,520 --> 00:39:43,080 BROADER ISSUE OF HOW DO WE THINK 1041 00:39:43,080 --> 00:39:44,080 ABOUT SOCIAL DETERMINANTS OF 1042 00:39:44,080 --> 00:39:45,600 HEALTH AND MAKE SURE WE'RE 1043 00:39:45,600 --> 00:39:47,240 INCORPORATING THEM INTO THIS 1044 00:39:47,240 --> 00:39:49,280 RESEARCH IN A WAY THAT MITIGATES 1045 00:39:49,280 --> 00:39:50,560 DISPARITIES AND OUTCOMES WE'RE 1046 00:39:50,560 --> 00:39:52,600 SEEING AND HOW CAN PHARMACIES -- 1047 00:39:52,600 --> 00:39:53,720 HOW CAN WE LEVERAGE PHARMACIES 1048 00:39:53,720 --> 00:39:54,920 TO DO THAT. 1049 00:39:54,920 --> 00:39:58,520 LASTLY I'LL MOVE INTO MY QUICK 1050 00:39:58,520 --> 00:39:58,840 SUMMARY. 1051 00:39:58,840 --> 00:40:00,240 PHARMACY-BASED HIV SERVICES HAVE 1052 00:40:00,240 --> 00:40:01,120 TREMENDOUS POTENTIAL TO IMPROVE 1053 00:40:01,120 --> 00:40:01,640 HEALTH. 1054 00:40:01,640 --> 00:40:03,240 PEOPLE FROM MANY SECTORS ARE 1055 00:40:03,240 --> 00:40:05,480 VERY MOTIVATED TO ADVANCE THIS 1056 00:40:05,480 --> 00:40:05,680 WORK. 1057 00:40:05,680 --> 00:40:07,480 VERY TALENTED PEOPLE ARE 1058 00:40:07,480 --> 00:40:08,560 STUDYING AND IMPLEMENTING THIS 1059 00:40:08,560 --> 00:40:09,040 ALREADY. 1060 00:40:09,040 --> 00:40:10,520 AND THE BODY OF LITERATURE 1061 00:40:10,520 --> 00:40:12,640 AROUND IT IS GROWING, REALLY 1062 00:40:12,640 --> 00:40:13,400 PROVING ITS VALUE. 1063 00:40:13,400 --> 00:40:15,560 BUT THERE'S PLENTY OF ROOM TO 1064 00:40:15,560 --> 00:40:17,240 GROW AND SEVERAL BARRIERS TO 1065 00:40:17,240 --> 00:40:17,640 OVERCOME. 1066 00:40:17,640 --> 00:40:19,760 SO THE QUESTION WE POSE TO THE 1067 00:40:19,760 --> 00:40:22,280 AUDIENCE IN JUNE, HOW CAN WE ALL 1068 00:40:22,280 --> 00:40:24,800 IN OUR RESPECTIVE ROLES HELP 1069 00:40:24,800 --> 00:40:27,600 OVERCOME BARRIERS, AND WHEN WE 1070 00:40:27,600 --> 00:40:29,600 TURN INTERNALLY AT THE NIH HOW 1071 00:40:29,600 --> 00:40:31,040 CAN WE HELP FOSTER RESEARCH TO 1072 00:40:31,040 --> 00:40:32,840 ANSWER THOSE QUESTIONS I PUT ON 1073 00:40:32,840 --> 00:40:36,480 THE BOARD AND OVERSOME THESE 1074 00:40:36,480 --> 00:40:37,360 ISSUES. 1075 00:40:37,360 --> 00:40:45,920 I'LL PASS IT TO MIKE TO TALK 1076 00:40:45,920 --> 00:40:46,760 ABOUT THE NEXT STEPS. 1077 00:40:46,760 --> 00:40:46,920 >> 1078 00:40:46,920 --> 00:40:51,920 >> I'M MIKE STIRRATT, PLEASED TO 1079 00:40:51,920 --> 00:40:53,320 PARTNER ON THE CO-CHAIRING OF 1080 00:40:53,320 --> 00:40:55,400 OUR HIV AND PHARMACY PLANNING 1081 00:40:55,400 --> 00:40:55,720 COMET. 1082 00:40:55,720 --> 00:40:57,440 SINCE OUR TIME IS TIGHT WE'LL 1083 00:40:57,440 --> 00:40:59,440 MENTION BRIEFLY SOME OF THE NEXT 1084 00:40:59,440 --> 00:41:00,560 STEPS FOR OUR PLANNING 1085 00:41:00,560 --> 00:41:00,800 COMMITTEE. 1086 00:41:00,800 --> 00:41:02,280 WE'RE WORKING RIGHT NOW ON 1087 00:41:02,280 --> 00:41:04,160 GETTING THE VIDEO POSTED FROM 1088 00:41:04,160 --> 00:41:05,680 OUR TWO-DAY MEETING IN JUNE, SO 1089 00:41:05,680 --> 00:41:06,880 THAT'S AVAILABLE TO THE PUBLIC. 1090 00:41:06,880 --> 00:41:09,080 THAT SHOULD BE AVAILABLE VERY 1091 00:41:09,080 --> 00:41:09,520 QUICKLY. 1092 00:41:09,520 --> 00:41:10,400 WE'RE ALSO TALKING ABOUT 1093 00:41:10,400 --> 00:41:12,600 OPPORTUNITIES TO DO A MEETING 1094 00:41:12,600 --> 00:41:14,680 SUMMARY THAT WE'LL PUBLISH AND 1095 00:41:14,680 --> 00:41:16,880 EFFORT TO COLLABORATE ON A 1096 00:41:16,880 --> 00:41:17,960 SPECIAL ISSUE JOURNAL SUPPLEMENT 1097 00:41:17,960 --> 00:41:21,920 THAT WOULD HIGHLIGHT WORK IN THE 1098 00:41:21,920 --> 00:41:23,880 PHARMACY SPACE, 1099 00:41:23,880 --> 00:41:24,640 PHARMACY-DELIVERED HIV TESTING 1100 00:41:24,640 --> 00:41:25,600 AND PrEP. 1101 00:41:25,600 --> 00:41:27,560 WE'RE PLEASED TO HAVE NIAID AS 1102 00:41:27,560 --> 00:41:29,440 OUR PARTNERS FROM THE VERY 1103 00:41:29,440 --> 00:41:31,640 BEGINNING, AND NIAID HAS 1104 00:41:31,640 --> 00:41:33,720 RECENTLY ISSUED A NUMBER OF 1105 00:41:33,720 --> 00:41:34,600 ADMINISTRATIVE SUPPLEMENTS 1106 00:41:34,600 --> 00:41:36,000 THROUGH EHE FUNDING WHICH ARE 1107 00:41:36,000 --> 00:41:41,560 SET TO PURCHASE PILOT PROJECTS 1108 00:41:41,560 --> 00:41:43,320 AND DELIVERY OF SERVICES THROUGH 1109 00:41:43,320 --> 00:41:44,440 PHARMACISTS AND PHARMACIES, A 1110 00:41:44,440 --> 00:41:46,280 GREAT PLATFORM TO BUILD ON FOR 1111 00:41:46,280 --> 00:41:47,360 FUTURE RESEARCH INITIATIVE. 1112 00:41:47,360 --> 00:41:49,040 WE LOOK FORWARD TO TAKING THESE 1113 00:41:49,040 --> 00:41:55,720 EFFORTS FORWARD IN THE FUTURE. 1114 00:41:55,720 --> 00:41:59,760 WORK IN HIV HAS BENEFITED FROM 1115 00:41:59,760 --> 00:42:01,520 COLLABORATION, THIS IS A 1116 00:42:01,520 --> 00:42:04,240 COLLABORATIVE EFFORT, AND WE'RE 1117 00:42:04,240 --> 00:42:08,200 GRATEFUL FOR THE PLANNING GROUP, 1118 00:42:08,200 --> 00:42:09,720 THANK YOU FOR THE CONTRIBUTIONS 1119 00:42:09,720 --> 00:42:12,360 AND HANG YOU TO THE ARAC TO 1120 00:42:12,360 --> 00:42:13,800 PRESENT THIS. 1121 00:42:13,800 --> 00:42:15,000 THERE'S PROMISE AND POTENTIAL 1122 00:42:15,000 --> 00:42:20,360 FOR RESEARCH TO SCALE, SPEED, 1123 00:42:20,360 --> 00:42:21,240 STRENGTHEN PHARMACIST AND 1124 00:42:21,240 --> 00:42:22,520 PHARMACY-DELIVERED PrEP AND 1125 00:42:22,520 --> 00:42:22,720 CARE. 1126 00:42:22,720 --> 00:42:23,960 AND LOOK FORWARD TO WORKING WITH 1127 00:42:23,960 --> 00:42:25,160 YOU ON THAT FRONT. 1128 00:42:25,160 --> 00:42:25,600 THANK YOU. 1129 00:42:25,600 --> 00:42:28,920 >> THANK YOU FOR SHARING THIS 1130 00:42:28,920 --> 00:42:31,360 INCREDIBLY IMPORTANT WORK WITH 1131 00:42:31,360 --> 00:42:32,000 US. 1132 00:42:32,000 --> 00:42:34,680 AND FOR THE TAG TEAM 1133 00:42:34,680 --> 00:42:35,200 PRESENTATION. 1134 00:42:35,200 --> 00:42:37,360 WE DON'T HAVE TIME FOR QUESTIONS 1135 00:42:37,360 --> 00:42:38,400 UNFORTUNATELY BUT IF YOU STAY 1136 00:42:38,400 --> 00:42:40,280 AROUND DURING THE BREAK I'M SURE 1137 00:42:40,280 --> 00:42:43,360 MANY PEOPLE WANT TO CHAT WITH 1138 00:42:43,360 --> 00:42:43,840 YOU. 1139 00:42:43,840 --> 00:42:49,440 THERE'S NOTHING TO VOTE ON. 1140 00:42:49,440 --> 00:42:54,720 WE'RE GOING TO MOVE TO TWO NEW 1141 00:42:54,720 --> 00:42:58,760 CONCEPTS, AND WE'RE STARTING 1142 00:42:58,760 --> 00:42:59,960 WITH GERARD LACOURCIERE 1143 00:42:59,960 --> 00:43:04,040 PRESENTING ONLINE ON STRATEGIES 1144 00:43:04,040 --> 00:43:05,600 FOR ELIMINATING HIV PROTEIN. 1145 00:43:05,600 --> 00:43:09,960 >> CAN YOU HEAR ME? 1146 00:43:09,960 --> 00:43:10,200 >> YES. 1147 00:43:10,200 --> 00:43:12,080 >> OKAY. 1148 00:43:12,080 --> 00:43:13,640 I'M PRESENTING TODAY FOR 1149 00:43:13,640 --> 00:43:16,800 APPROVAL MY CONCEPT, STRATEGIES 1150 00:43:16,800 --> 00:43:19,840 FOR ELIMINATING HIV PROTEINS. 1151 00:43:19,840 --> 00:43:21,960 NEXT SLIDE PLEASE. 1152 00:43:21,960 --> 00:43:23,440 THIS ONE-TIME INITIATIVE IS 1153 00:43:23,440 --> 00:43:25,240 DEVELOPMENT OF MOLECULES THAT 1154 00:43:25,240 --> 00:43:28,640 TARGET HIV PROTEINS, OR RNA FOR 1155 00:43:28,640 --> 00:43:30,680 DEGRADATION OR INTERFERE WITH 1156 00:43:30,680 --> 00:43:32,880 TRANSLATION INTO PROTEIN. 1157 00:43:32,880 --> 00:43:35,400 WHILE UNPROVEN, THIS NEW TYPE OF 1158 00:43:35,400 --> 00:43:36,920 DRUG HAS POTENTIAL TO ELIMINATE 1159 00:43:36,920 --> 00:43:38,920 HIV PROTEINS THAT HAVE PROVEN 1160 00:43:38,920 --> 00:43:41,400 DIFFICULT TO TARGET VIA 1161 00:43:41,400 --> 00:43:43,160 TRADITIONAL DRUG DISCOVERY 1162 00:43:43,160 --> 00:43:45,680 METHODOLOGIES, A NEW INITIATIVE, 1163 00:43:45,680 --> 00:43:47,560 PROPOSING GRANT MECHANISM, 1164 00:43:47,560 --> 00:43:52,040 METHOD OF SOLITICATION AN RFA, 1165 00:43:52,040 --> 00:43:54,560 PROPOSING BOTH R21 AND R01 1166 00:43:54,560 --> 00:43:57,200 GRANT, TWO TO FIVE YEARS, 1167 00:43:57,200 --> 00:43:59,880 ESTIMATED BUDGET OF $2 MILLION, 1168 00:43:59,880 --> 00:44:01,760 ANTICIPATING TO FUND BETWEEN 1169 00:44:01,760 --> 00:44:04,920 FOUR TO FIVE AWARDS. 1170 00:44:04,920 --> 00:44:05,720 NEXT SLIDE. 1171 00:44:05,720 --> 00:44:08,040 CURRENT DRUGS USED TO CONTROL 1172 00:44:08,040 --> 00:44:09,720 INFECTION BLOCK ACTIVITY OF 1173 00:44:09,720 --> 00:44:12,440 ENZYMES CRITICAL TO VIRAL LIFE 1174 00:44:12,440 --> 00:44:15,280 CYCLE INCLUDING REVERSE 1175 00:44:15,280 --> 00:44:15,920 TRANSCRIPTATION, INTEGRASE, 1176 00:44:15,920 --> 00:44:18,800 PROTEASE, BLOCKED DIFFUSION OF 1177 00:44:18,800 --> 00:44:20,200 VIRUS THROUGH HOST CELL 1178 00:44:20,200 --> 00:44:21,760 RECEPTORS, STRATEGIES MAY BE 1179 00:44:21,760 --> 00:44:23,800 SUCCESSFUL TARGETING ALL HIV 1180 00:44:23,800 --> 00:44:25,920 PROTEINS, THIS INITIATIVE SEEKS 1181 00:44:25,920 --> 00:44:26,760 TO APPLY NEW THERAPEUTIC 1182 00:44:26,760 --> 00:44:29,720 STRATEGIES THAT ARE CAPABLE OF 1183 00:44:29,720 --> 00:44:30,720 TARGETING ALL HIV PROTEINS. 1184 00:44:30,720 --> 00:44:33,480 THIS CAN BE ACHIEVED BY THE 1185 00:44:33,480 --> 00:44:36,000 TARGETED DEGRADATION OF PROTEINS 1186 00:44:36,000 --> 00:44:39,480 OR ENCODING RNA OR DEVELOPMENT 1187 00:44:39,480 --> 00:44:42,640 OF SMALL MOLECULES THAT PREVENT 1188 00:44:42,640 --> 00:44:43,400 PROCESSING. 1189 00:44:43,400 --> 00:44:44,200 WE'LL REMOVE BIOLOGICAL 1190 00:44:44,200 --> 00:44:47,240 FUNCTIONS OF THE TARGETED 1191 00:44:47,240 --> 00:44:49,080 PROTEIN, MAY OVERCOME RESISTANCE 1192 00:44:49,080 --> 00:44:50,400 AND DRUG TOXICITY. 1193 00:44:50,400 --> 00:44:52,160 THIS CAN BE EXPANDED TO HIV 1194 00:44:52,160 --> 00:44:53,480 TARGETS WHICH HAVE BEEN 1195 00:44:53,480 --> 00:44:56,640 DIFFICULT TO INHIBIT. 1196 00:44:56,640 --> 00:45:02,040 NEXT SLIDE. 1197 00:45:02,040 --> 00:45:05,840 SO ONE INTRACELLULAR PRO 1198 00:45:05,840 --> 00:45:07,440 PROTEIN CAN BE REMOVED CAN BE 1199 00:45:07,440 --> 00:45:10,520 ACCOMPLISHED WITH A SMALL 1200 00:45:10,520 --> 00:45:18,440 MOLECULE, PROTEOLYSIS TARGETING 1201 00:45:18,440 --> 00:45:22,280 CHIMERA, BIFUNCTIONAL MOLECULE, 1202 00:45:22,280 --> 00:45:27,640 PROTEIN OF INTEREST, SECOND 1203 00:45:27,640 --> 00:45:29,200 LIGAND TARGETS UBIQUITINATION 1204 00:45:29,200 --> 00:45:29,800 PATHWAY, WHEN INTERNALIZED, 1205 00:45:29,800 --> 00:45:33,040 PROTEIN OF INTEREST IS PRESENT, 1206 00:45:33,040 --> 00:45:38,880 AS WELL AS E3 LIGASE, IT WILL 1207 00:45:38,880 --> 00:45:41,000 UBIQUINATE PROTEIN OF INTEREST, 1208 00:45:41,000 --> 00:45:42,080 DIRECTED TO PROTEASOME, REMOVING 1209 00:45:42,080 --> 00:45:45,600 IT FROM THE CELL. 1210 00:45:45,600 --> 00:45:46,480 NEXT SLIDE. 1211 00:45:46,480 --> 00:45:48,880 PROTEIN DEGRADATION IS AN 1212 00:45:48,880 --> 00:45:50,600 EXPANDING AREA OF THERAPEUTIC 1213 00:45:50,600 --> 00:45:50,920 DEVELOPMENT. 1214 00:45:50,920 --> 00:45:53,800 IT'S BEEN SHOWN TO BE EFFECTIVE 1215 00:45:53,800 --> 00:45:56,320 STRATEGY FOR TARGETING 1216 00:45:56,320 --> 00:45:57,840 UNDRUGGABLE PROTEINS. 1217 00:45:57,840 --> 00:45:59,480 MULTIPLE PROTACS HAVE BEEN 1218 00:45:59,480 --> 00:46:04,280 DEVELOPED AND REPORTED FOR 1219 00:46:04,280 --> 00:46:05,280 ONCOLOGY, AUTOIMMUNE 1220 00:46:05,280 --> 00:46:06,400 INFLAMMATION, AND 1221 00:46:06,400 --> 00:46:07,480 NEURODEGENERATIVE TARGETS. 1222 00:46:07,480 --> 00:46:09,240 THERE IS AT LEAST ONE 1223 00:46:09,240 --> 00:46:11,880 PUBLICATION THAT I'M AWARE OF, 1224 00:46:11,880 --> 00:46:13,600 ONE ANTI-VIRAL PROTAC THAT'S 1225 00:46:13,600 --> 00:46:15,560 BEEN DEVELOPED, THIS ONE WAS 1226 00:46:15,560 --> 00:46:18,400 TARGETING PROTEASE OF THE 1227 00:46:18,400 --> 00:46:19,720 HEPATITIS C VIRUS. 1228 00:46:19,720 --> 00:46:22,320 PROTEIN DEGRADATION IS AN AREA 1229 00:46:22,320 --> 00:46:24,360 OF INTEREST IN BIG PHARMA AND 1230 00:46:24,360 --> 00:46:25,880 BIOTECH, AND IN REVIEW THAT CAME 1231 00:46:25,880 --> 00:46:28,920 OUT A COUPLE YEARS AGO, IT WAS 1232 00:46:28,920 --> 00:46:31,360 REPORTED THAT THERE WERE 15 1233 00:46:31,360 --> 00:46:32,840 PROTACs IN CLINICAL 1234 00:46:32,840 --> 00:46:34,600 DEVELOPMENT, FOCUSED ON ONCOLOGY 1235 00:46:34,600 --> 00:46:35,880 AND AUTOIMMUNE TARGETS. 1236 00:46:35,880 --> 00:46:38,760 EARLIER THIS YEAR ONE OF THESE 1237 00:46:38,760 --> 00:46:41,640 MOLECULES TRANSITIONED TO PHASE 1238 00:46:41,640 --> 00:46:44,160 3, PROTAC WHICH IS BEING 1239 00:46:44,160 --> 00:46:45,480 DEVELOPED, MOVING CLOSER TO 1240 00:46:45,480 --> 00:46:46,560 LICENSED PRODUCT. 1241 00:46:46,560 --> 00:46:49,600 THERE IS THE CLINICAL AND 1242 00:46:49,600 --> 00:46:50,240 REGULATORY PATHWAY ESTABLISHED, 1243 00:46:50,240 --> 00:46:52,920 AND THESE TYPE OF MOLECULES ARE 1244 00:46:52,920 --> 00:46:55,880 FORMULATED FOR ORAL DELIVERY. 1245 00:46:55,880 --> 00:46:57,800 SO, PROTACs HAVE BEEN AROUND 1246 00:46:57,800 --> 00:46:58,960 FOR 20 YEARS. 1247 00:46:58,960 --> 00:47:01,560 THEY ARE THE MOST WIDELY KNOWN 1248 00:47:01,560 --> 00:47:03,600 AND WIDELY USED PROTEIN 1249 00:47:03,600 --> 00:47:07,200 DEGRADATION PLATFORMS. 1250 00:47:07,200 --> 00:47:07,520 NEXT SLIDE. 1251 00:47:07,520 --> 00:47:09,960 IN THE LAST FEW YEARS THERE HAVE 1252 00:47:09,960 --> 00:47:12,880 BEEN NEW PLATFORMS DEVELOPED AND 1253 00:47:12,880 --> 00:47:16,440 REPORTED WHICH ALSO ARE CAPABLE 1254 00:47:16,440 --> 00:47:18,840 OF DEGRADING CELLULAR PROTEIN. 1255 00:47:18,840 --> 00:47:24,520 I'LL HIGHLIGHT TWO ADDITIONAL 1256 00:47:24,520 --> 00:47:25,600 PLATFORMS, FIRST IS AUTACs, 1257 00:47:25,600 --> 00:47:27,480 SIMILAR TO WHAT I JUST DESCRIBED 1258 00:47:27,480 --> 00:47:30,520 WITH THE PROTAC, A LIGAND THAT 1259 00:47:30,520 --> 00:47:32,080 TARGETS CELLULAR PRODUCT, 1260 00:47:32,080 --> 00:47:38,200 CONNECTED TO A LINKER, BUT THIS 1261 00:47:38,200 --> 00:47:42,120 LIGAND WILL RECRUIT COMPONENT OF 1262 00:47:42,120 --> 00:47:43,760 THE AUTOPHAGOSOMAL PATHWAY TO 1263 00:47:43,760 --> 00:47:45,200 TARGET DEGRADATION OF CELLULAR 1264 00:47:45,200 --> 00:47:50,640 COMPONENTS, SHOWN TO BE 1265 00:47:50,640 --> 00:47:51,520 EFFECTIVE IN DEGRADING PROTEINS, 1266 00:47:51,520 --> 00:47:55,560 ONE EXAMPLE IT WAS ABLE TO 1267 00:47:55,560 --> 00:47:56,880 DEGRADE ORGANELLE, SPECIFICALLY 1268 00:47:56,880 --> 00:47:58,520 BIND TO DYSFUNCTIONAL 1269 00:47:58,520 --> 00:48:00,680 MITOCHONDRIA AND DEGRADE IT. 1270 00:48:00,680 --> 00:48:03,120 ANOTHER PLATFORM WHICH HAS BEEN 1271 00:48:03,120 --> 00:48:05,760 REPORTED THAT CAN DEGRADE 1272 00:48:05,760 --> 00:48:09,440 CELLULAR PROTEINS IS A LYTAC, 1273 00:48:09,440 --> 00:48:15,040 THIS PLATFORM IS USED TO DEGRADE 1274 00:48:15,040 --> 00:48:16,600 MEMBRANE BOUND PROTEINS, THE 1275 00:48:16,600 --> 00:48:19,080 EXAMPLE IN THE FIGURE A FULL 1276 00:48:19,080 --> 00:48:20,840 LENGTH ANTIBODY WHICH TARGETS 1277 00:48:20,840 --> 00:48:23,800 EITHER INTRACELLULAR PROTEIN OR 1278 00:48:23,800 --> 00:48:24,880 MEMBRANE-BOUND PROTEIN 1279 00:48:24,880 --> 00:48:27,600 CONJUGATED TO LINKER, CONTAINING 1280 00:48:27,600 --> 00:48:34,080 A LIGAND WHICH BINDS TO LYSOSOME 1281 00:48:34,080 --> 00:48:36,040 RECEPTOR, INTERACTS WITH THE 1282 00:48:36,040 --> 00:48:37,320 LYSOSOME TARGETING RECEPTOR TO 1283 00:48:37,320 --> 00:48:40,120 BECOME INTERNALIZED, SENT TO THE 1284 00:48:40,120 --> 00:48:41,320 LYSOSOME DEGRADED. 1285 00:48:41,320 --> 00:48:46,000 THERE'S AN EXAMPLE HOW THIS WAS 1286 00:48:46,000 --> 00:48:48,320 EFFECTIVE IN DEGRADING THE PD-L1 1287 00:48:48,320 --> 00:48:58,840 RECEPTOR ON THE CELL SURFACE. 1288 00:49:00,880 --> 00:49:11,240 YOU CAN TAR TARGETS RNA. 1289 00:49:12,320 --> 00:49:15,240 RIBOTAC IS SIMILAR, I WILLING 1290 00:49:15,240 --> 00:49:20,720 AND -- A LIGAND AT ONE END, THE 1291 00:49:20,720 --> 00:49:22,000 SECOND LIGAND RECRUITS RNA, 1292 00:49:22,000 --> 00:49:22,880 CELLULAR RNA. 1293 00:49:22,880 --> 00:49:26,280 IF THE RNA IS PRESENT IN THE 1294 00:49:26,280 --> 00:49:31,680 CELL, SMALL MOLECULE BINDS IT 1295 00:49:31,680 --> 00:49:33,520 WAS DELIVER RNAASE AND DEGRADE 1296 00:49:33,520 --> 00:49:35,680 IT, PROTEIN WILL NOT BE 1297 00:49:35,680 --> 00:49:36,160 TRANSLATED. 1298 00:49:36,160 --> 00:49:37,560 THERE ARE OTHER STRATEGIES WHICH 1299 00:49:37,560 --> 00:49:42,520 CAN TARGET RNA FOR DEGRADATION 1300 00:49:42,520 --> 00:49:52,320 SUCH AS siRNA OR CAS13. 1301 00:49:52,320 --> 00:49:55,760 IT WAS SUCCESSFUL IN DEGRADING 1302 00:49:55,760 --> 00:50:02,960 NON-CODING RNA, MAINRY LY 1303 00:50:02,960 --> 00:50:06,120 microRNA 21, ALSO DEGRADATION 1304 00:50:06,120 --> 00:50:07,000 OF SARS-COV-2. 1305 00:50:07,000 --> 00:50:10,280 SO, IN ADDITION TO TARGETING RNA 1306 00:50:10,280 --> 00:50:12,800 FOR DEGRADATION, RNA CAN BE 1307 00:50:12,800 --> 00:50:15,720 TARGETED WITH SMALL MOLECULES OR 1308 00:50:15,720 --> 00:50:18,040 NUCLEOTIDE BASED THERAPY TO 1309 00:50:18,040 --> 00:50:20,400 PREVENT RNA PROCESSING, SPLICING 1310 00:50:20,400 --> 00:50:24,080 OR TRANSLATION. 1311 00:50:24,080 --> 00:50:27,920 THIS EXAMPLE SHOWN HERE, IT'S 1312 00:50:27,920 --> 00:50:29,200 FOCUSED ON PROTEIN 1313 00:50:29,200 --> 00:50:30,840 ALPHA-SYNUCLEIN, UPREGULATED IN 1314 00:50:30,840 --> 00:50:32,520 DEVELOPMENT OF PARKINSON'S 1315 00:50:32,520 --> 00:50:34,680 DISEASE, LONG BEEN CONSIDERED 1316 00:50:34,680 --> 00:50:35,360 THERAPEUTIC TARGET. 1317 00:50:35,360 --> 00:50:37,240 THE PROTEIN HAS NOT BEEN ABLE TO 1318 00:50:37,240 --> 00:50:40,160 BE INHIBITED WITH SMALL 1319 00:50:40,160 --> 00:50:42,480 MOLECULES, SO WHAT THIS PAPER 1320 00:50:42,480 --> 00:50:48,280 SHOWED WAS A SMALL MOLECULE WAS 1321 00:50:48,280 --> 00:50:50,880 DEVELOPED, BINDS TO THIS 1322 00:50:50,880 --> 00:50:53,200 STRUCTURAL ELEMENT PRESENT IN 1323 00:50:53,200 --> 00:50:54,720 THE FIVE PRIME UNTRANSLATED 1324 00:50:54,720 --> 00:50:58,120 REGION OF THE mRNA BEFORE THE 1325 00:50:58,120 --> 00:51:00,640 START CODON, FOUND WHEN THIS IS 1326 00:51:00,640 --> 00:51:03,160 BOUND IN THIS PART OF THE 1327 00:51:03,160 --> 00:51:04,600 STEM-LOOP IT BLOCKS RIBOSOME 1328 00:51:04,600 --> 00:51:06,840 FROM MOVING FORWARD AND 1329 00:51:06,840 --> 00:51:07,520 TRANSLATING PROTEIN. 1330 00:51:07,520 --> 00:51:11,680 EVEN THOUGH RNA IS PRESENT, THE 1331 00:51:11,680 --> 00:51:12,440 SMALL MOLECULE BLOCKS 1332 00:51:12,440 --> 00:51:13,640 TRANSLATION OF THE RNA INTO 1333 00:51:13,640 --> 00:51:14,720 PROTEIN AND ESSENTIALLY NO 1334 00:51:14,720 --> 00:51:16,400 PROTEIN IS MADE. 1335 00:51:16,400 --> 00:51:18,360 SO SMALL MOLECULES THAT TARGET 1336 00:51:18,360 --> 00:51:23,880 RNA ARE ALSO AN INTEREST TO BIG 1337 00:51:23,880 --> 00:51:27,040 PHARMA AND SMALL BIOTECHS, I 1338 00:51:27,040 --> 00:51:30,720 WANT TO HIGHLIGHT IN 2020 THE 1339 00:51:30,720 --> 00:51:35,160 FDA APPROVED FIRST SMALL 1340 00:51:35,160 --> 00:51:38,280 MOLECULE WHICH TARGETS RNA, 1341 00:51:38,280 --> 00:51:41,040 EVRYSDI USED IN TREATMENT OF 1342 00:51:41,040 --> 00:51:42,440 SPINAL MUSCULAR ATROPHY. 1343 00:51:42,440 --> 00:51:43,440 NEXT SLIDE. 1344 00:51:43,440 --> 00:51:47,280 SO, WHAT WE WANT TO ACCOMPLISH, 1345 00:51:47,280 --> 00:51:51,960 WE WOULD LIKE TO SUPPORT 1346 00:51:51,960 --> 00:51:53,320 PROJECTS THAT DESIGN, OPTIMIZE, 1347 00:51:53,320 --> 00:51:55,360 STRATEGIES FOR TARGETING HIV 1348 00:51:55,360 --> 00:52:00,560 PROTEINS, RNA THAT ENCODES THEM 1349 00:52:00,560 --> 00:52:00,960 FOR DEGRADATION. 1350 00:52:00,960 --> 00:52:02,280 SUPPORT SMALL MOLECULE PROJECTS 1351 00:52:02,280 --> 00:52:07,560 THAT INTERFERE WITH PROCESS IN 1352 00:52:07,560 --> 00:52:08,920 TRANSCRIPTION AND TRANSLATION, 1353 00:52:08,920 --> 00:52:11,600 THAT TARGET HOST CELL PROTEINS 1354 00:52:11,600 --> 00:52:13,760 IF PRE-VALIDATED HIV DEPENDENCY 1355 00:52:13,760 --> 00:52:17,440 FACTORS, ESSENTIAL FOR HIV 1356 00:52:17,440 --> 00:52:18,080 REPLICATION, SUPPORT TECHNOLOGY 1357 00:52:18,080 --> 00:52:19,760 DEVELOPMENT SPECIFICALLY FOCUSED 1358 00:52:19,760 --> 00:52:22,400 ON HIV TARGET, AND ALSO SUPPORT 1359 00:52:22,400 --> 00:52:25,920 PROOF OF CONCEPT STUDIES IN HIV 1360 00:52:25,920 --> 00:52:33,120 INFECTED CELLS IN SMALL ANIMAL 1361 00:52:33,120 --> 00:52:33,360 MODELS. 1362 00:52:33,360 --> 00:52:34,560 APPLICATIONS PROPOSING ANY OF 1363 00:52:34,560 --> 00:52:37,520 THE FOLLOWING RESEARCH TOPICS 1364 00:52:37,520 --> 00:52:41,200 WILL NOT BE SUPPORTED, ANIMAL 1365 00:52:41,200 --> 00:52:42,400 MODELS USING NON-HUMAN PRIMATE, 1366 00:52:42,400 --> 00:52:44,720 AND THIS INITIATIVE WILL NOT 1367 00:52:44,720 --> 00:52:48,240 SUPPORT CLINICAL TRIALS. 1368 00:52:48,240 --> 00:52:50,640 NEXT SLIDE. 1369 00:52:50,640 --> 00:52:53,120 SO WHERE DOES THIS FIT? 1370 00:52:53,120 --> 00:52:56,200 FOCUSED ON DRUG DISCOVERY, FITS 1371 00:52:56,200 --> 00:52:59,800 WELL INTO THE BASIC RESEARCH 1372 00:52:59,800 --> 00:53:01,360 PORTFOLIO. 1373 00:53:01,360 --> 00:53:03,320 EXPECTATION WOULD BE THAT AS 1374 00:53:03,320 --> 00:53:04,760 COMPOUNDS ARE DEVELOPED THEY 1375 00:53:04,760 --> 00:53:07,040 WOULD MOVE, PROGRESS TOWARDS 1376 00:53:07,040 --> 00:53:08,000 PRE-CLINICAL AND CLINICAL 1377 00:53:08,000 --> 00:53:10,320 CANDIDATES, SO IT'S RIGHT AT THE 1378 00:53:10,320 --> 00:53:12,960 CUSP OF BASIC RESEARCH AND 1379 00:53:12,960 --> 00:53:13,720 TRANSLATIONAL RESEARCH. 1380 00:53:13,720 --> 00:53:16,080 THERE HAVE BEEN SOME OTHER 1381 00:53:16,080 --> 00:53:19,520 AWARDS OR PROGRAMS ISSUED OVER 1382 00:53:19,520 --> 00:53:22,080 THE YEARS, WHICH ARE SIMILAR TO 1383 00:53:22,080 --> 00:53:24,280 WHAT I'M PROPOSING, ALL OF THEM 1384 00:53:24,280 --> 00:53:26,080 HAVE EXPIRED AND THERE ARE NO 1385 00:53:26,080 --> 00:53:26,920 ACTIVE PROGRAMS TO SUPPORT THIS 1386 00:53:26,920 --> 00:53:33,440 TYPE OF WORK AT THE MOMENT. 1387 00:53:33,440 --> 00:53:37,120 NEXT SLIDE. 1388 00:53:37,120 --> 00:53:38,800 SO, PRE-ARAC REVIEWERS, DR. 1389 00:53:38,800 --> 00:53:40,200 HARRIS AND DR. JEROME, I THANK 1390 00:53:40,200 --> 00:53:45,160 THEM FOR THEIR TIME AND FEEDBACK 1391 00:53:45,160 --> 00:53:46,680 IN DEVELOPING THIS INITIATIVE. 1392 00:53:46,680 --> 00:53:48,880 AT THE MEETING THEY RECOMMENDED 1393 00:53:48,880 --> 00:53:50,600 APPROVAL OF THIS PROPOSED 1394 00:53:50,600 --> 00:53:51,160 INITIATIVE. 1395 00:53:51,160 --> 00:53:53,240 I WILL JUST GO THROUGH SOME 1396 00:53:53,240 --> 00:53:55,560 COMMENTS MADE DURING THE REVIEW, 1397 00:53:55,560 --> 00:53:57,400 AND OUR RESPONSE TO THEM. 1398 00:53:57,400 --> 00:54:01,240 IT MIGHT BE USEFUL TO SPECIFY 1399 00:54:01,240 --> 00:54:02,960 WHETHER YOU INTEND siRNA OR 1400 00:54:02,960 --> 00:54:10,640 CASS 13 OR OTHER MECHANISMS TO 1401 00:54:10,640 --> 00:54:12,960 BE CONSIDERED RESPONSIVE. 1402 00:54:12,960 --> 00:54:14,480 YES, WE'LL CONSIDER TO BE 1403 00:54:14,480 --> 00:54:14,760 RESPONSIVE. 1404 00:54:14,760 --> 00:54:17,960 IF YOU FAVOR SMALL ANIMAL MODELS 1405 00:54:17,960 --> 00:54:20,160 SINCE THIS FIELD IS RELATIVELY 1406 00:54:20,160 --> 00:54:25,480 NEW IT MAY BE USEFUL TO CLARIFY. 1407 00:54:25,480 --> 00:54:27,520 YES, LIMITED TO SMALL ANIMAL 1408 00:54:27,520 --> 00:54:33,680 MODELS AS PROOF OF CONCEPT. 1409 00:54:33,680 --> 00:54:35,480 CITE/LIST PRECEDENCE FOR 1410 00:54:35,480 --> 00:54:37,000 PROTACs, DURING MY 1411 00:54:37,000 --> 00:54:40,840 PRESENTATION I DID NOT INCLUDE 1412 00:54:40,840 --> 00:54:43,240 REFERENCE FOR THE PROTAC 1413 00:54:43,240 --> 00:54:44,960 GENERATED AGAINST HEPATITIS C 1414 00:54:44,960 --> 00:54:45,800 PROTEASE PROTEIN. 1415 00:54:45,800 --> 00:54:49,560 I DID INCLUDE IT IN THIS TALK. 1416 00:54:49,560 --> 00:54:53,080 AND THE RESPONSE TO THE GENERAL 1417 00:54:53,080 --> 00:54:55,240 QUESTION, I DON'T HAVE A GOOD 1418 00:54:55,240 --> 00:54:55,640 ANSWER. 1419 00:54:55,640 --> 00:55:02,160 IT IS A GAP THAT WE ALSO SEE IN 1420 00:55:02,160 --> 00:55:03,240 TERMS OF HIV THERAPEUTIC 1421 00:55:03,240 --> 00:55:04,440 DEVELOPMENT, THAT'S ONE OF THE 1422 00:55:04,440 --> 00:55:06,280 REASONS I'M PROPOSING THIS 1423 00:55:06,280 --> 00:55:08,440 INITIATIVE IS TO STIMULATE MORE 1424 00:55:08,440 --> 00:55:09,840 INTEREST IN DEVELOPING THESE 1425 00:55:09,840 --> 00:55:13,120 TYPE OF THERAPEUTICS. 1426 00:55:13,120 --> 00:55:15,880 NEXT SLIDE. 1427 00:55:15,880 --> 00:55:20,480 IN ADDITION TO SMALL MOLECULES 1428 00:55:20,480 --> 00:55:28,360 CONSIDER TARGETING WITH ODN OR 1429 00:55:28,360 --> 00:55:30,880 NUCLEIC ARSED BASED THERAPIES, 1430 00:55:30,880 --> 00:55:31,400 YES. 1431 00:55:31,400 --> 00:55:32,640 RESEARCH MAY INCLUDE TECHNOLOGY 1432 00:55:32,640 --> 00:55:35,440 DEVELOPMENT IF FOCUSED ON HIV 1433 00:55:35,440 --> 00:55:37,880 TARGETS, WE AGREE AND WILL BE 1434 00:55:37,880 --> 00:55:39,400 WRITTEN TO INCLUDE TECHNOLOGY 1435 00:55:39,400 --> 00:55:39,960 DEVELOPMENT. 1436 00:55:39,960 --> 00:55:41,160 AND RESEARCH MAY INCLUDE 1437 00:55:41,160 --> 00:55:43,680 CELLULAR TARGETS IF BONE A FIGHT 1438 00:55:43,680 --> 00:55:46,640 HIV DEPENDENCY FACTORS ESSENTIAL 1439 00:55:46,640 --> 00:55:47,840 FOR HIV REPLICATION, AND WE 1440 00:55:47,840 --> 00:55:51,000 AGREE AND THE RFA WILL ALLOW 1441 00:55:51,000 --> 00:55:54,520 HOST TARGETS IF PRE-VALIDATED AS 1442 00:55:54,520 --> 00:55:56,560 ESSENTIAL FOR HIV REPLICATION. 1443 00:55:56,560 --> 00:55:59,640 NEXT SLIDE. 1444 00:55:59,640 --> 00:56:05,680 AND THIS IS MY FINAL SLIDE. 1445 00:56:05,680 --> 00:56:07,320 >> EXCELLENT. 1446 00:56:07,320 --> 00:56:09,040 THANK YOU SO MUCH. 1447 00:56:09,040 --> 00:56:14,320 THE PRESENTATION IS OPEN FOR 1448 00:56:14,320 --> 00:56:15,440 QUESTIONS. 1449 00:56:15,440 --> 00:56:17,720 >> THAT'S REALLY INTERESTING AND 1450 00:56:17,720 --> 00:56:17,920 NOVEL. 1451 00:56:17,920 --> 00:56:20,120 MONICA GANDHI, UCSF. 1452 00:56:20,120 --> 00:56:21,680 THAT'S NOVEL IN TERMS OF 1453 00:56:21,680 --> 00:56:24,720 THERAPEUTIC TARGETS BUT YOU 1454 00:56:24,720 --> 00:56:27,520 MENTIONED THE QUESTION 1455 00:56:27,520 --> 00:56:28,000 PHARMACEUTICAL COMPANIES 1456 00:56:28,000 --> 00:56:28,880 INTERACTING, WOULD THIS BE 1457 00:56:28,880 --> 00:56:30,120 SOMETHING YOU ENVISION A GROUP 1458 00:56:30,120 --> 00:56:33,280 IN ACADEMIA DOES WITH A 1459 00:56:33,280 --> 00:56:38,000 PHARMACEUTICAL COMPANY, AND IF 1460 00:56:38,000 --> 00:56:40,200 SO IS IT SBIR OR SOMETHING? 1461 00:56:40,200 --> 00:56:42,040 >> I'LL CONSIDER THAT. 1462 00:56:42,040 --> 00:56:45,560 THANK YOU. 1463 00:56:45,560 --> 00:56:51,120 >> ARE THERE OTHER QUESTIONS? 1464 00:56:51,120 --> 00:56:53,000 >> JUST A COMMENT. 1465 00:56:53,000 --> 00:56:55,760 RUBEN HARRIS. 1466 00:56:55,760 --> 00:56:59,480 WELL SUMMARIZEED, GERARD. 1467 00:56:59,480 --> 00:57:00,200 THANK YOU. 1468 00:57:00,200 --> 00:57:01,360 >> THANKS. 1469 00:57:01,360 --> 00:57:04,280 >> ANY QUESTIONS ONLINE? 1470 00:57:04,280 --> 00:57:08,200 1471 00:57:08,200 --> 00:57:11,040 >> KEITH JEROME, ONE OF THE 1472 00:57:11,040 --> 00:57:11,840 REVIEWERS. 1473 00:57:11,840 --> 00:57:14,800 I WANT TO SAY THAT, GERARD, THIS 1474 00:57:14,800 --> 00:57:15,840 IS VERY RESPONSIVE TO COMMENTS 1475 00:57:15,840 --> 00:57:16,720 WE HAD. 1476 00:57:16,720 --> 00:57:19,360 I'LL MAKE THE POINT THAT TO 1477 00:57:19,360 --> 00:57:22,960 REITERATE, I THINK THIS IS A 1478 00:57:22,960 --> 00:57:26,080 REALLY PROMISING APPROACH, AND 1479 00:57:26,080 --> 00:57:26,920 VERY IMPORTANT COMPLEMENT, 1480 00:57:26,920 --> 00:57:28,720 FILLING A GAP IN THE CURRENT 1481 00:57:28,720 --> 00:57:30,440 PORTFOLIO, AN AREA THAT SHOULD 1482 00:57:30,440 --> 00:57:32,440 BE RESEARCHED, IT'S JUST NOT 1483 00:57:32,440 --> 00:57:39,560 BEING ADDRESSED RIGHT NOW. 1484 00:57:39,560 --> 00:57:41,720 >> WITH THAT COMMENT, I'LL URGE 1485 00:57:41,720 --> 00:57:45,360 EVERYBODY TO PLEASE VOTE. 1486 00:57:45,360 --> 00:57:46,640 AND WE'LL THANK YOU. 1487 00:57:46,640 --> 00:57:49,440 WE'LL MOVE TO THE NEXT 1488 00:57:49,440 --> 00:57:59,720 PRESENTATION. 1489 00:58:03,560 --> 00:58:06,680 1490 00:58:06,680 --> 00:58:09,160 >> BRING THE MIC CLOSER. 1491 00:58:09,160 --> 00:58:13,880 >> THIS IS LIMITED INTERACTION 1492 00:58:13,880 --> 00:58:15,760 TARGETED EPIDEMIOLOGY, LITE. 1493 00:58:15,760 --> 00:58:17,280 TRANSMISSION AND TREATMENT AMONG 1494 00:58:17,280 --> 00:58:20,520 VULNERABLE POPULATIONS IN LATIN 1495 00:58:20,520 --> 00:58:21,520 AMERICA, LITE-LA. 1496 00:58:21,520 --> 00:58:23,960 THE PURPOSE IS TO SUPPORT STATUS 1497 00:58:23,960 --> 00:58:25,600 NEUTRAL RESEARCH TO IMPROVE 1498 00:58:25,600 --> 00:58:27,480 PREVENTION AND TREATMENT IN 1499 00:58:27,480 --> 00:58:29,440 LATIN AMERICA BY USING REMOTE 1500 00:58:29,440 --> 00:58:33,120 METHODS TO ENROLL, TEST, FOLLOW 1501 00:58:33,120 --> 00:58:35,680 NEGATIVE PERSONS OR VULNERABLE 1502 00:58:35,680 --> 00:58:37,440 AND PEOPLE LIVING WITH HIV NOT 1503 00:58:37,440 --> 00:58:39,480 LIKELY TO BE VIRALLY SUPPRESSED, 1504 00:58:39,480 --> 00:58:41,680 FOCUSING ON PERSONAL AND 1505 00:58:41,680 --> 00:58:43,240 STRUCTURAL FACTORS IMPACTING HIV 1506 00:58:43,240 --> 00:58:46,760 ACQUISITION OR AMONG PEOPLE WITH 1507 00:58:46,760 --> 00:58:48,280 HIV, HIV VIREMIA, IDENTIFYING 1508 00:58:48,280 --> 00:58:51,800 SUBGROUPS AND HOT SPOTS WITH 1509 00:58:51,800 --> 00:58:54,200 INCREASED RISK, ADDRESSING A GAP 1510 00:58:54,200 --> 00:59:00,320 IN KNOWLEDGE THOSE MOST 1511 00:59:00,320 --> 00:59:06,920 VULNERABLE TO ACQUIRING, THE 1512 00:59:06,920 --> 00:59:08,440 GRANTEES RECEIVE TWO YEARS OF 1513 00:59:08,440 --> 00:59:11,160 FUNDING TO DEVELOP LARGE COHORTS 1514 00:59:11,160 --> 00:59:13,360 AND THEN MEET MILESTONES IN 1515 00:59:13,360 --> 00:59:17,840 TERMS OF RECRUITMENT AND NUMBER 1516 00:59:17,840 --> 00:59:19,160 OF PEOPLE WHO SEROCONVERT. 1517 00:59:19,160 --> 00:59:21,200 IF THEY ARE SUCCESSFUL THEY GET 1518 00:59:21,200 --> 00:59:24,840 ADDITIONAL THREE YEARS OF 1519 00:59:24,840 --> 00:59:25,080 FUNDING. 1520 00:59:25,080 --> 00:59:28,320 NIAID FUNDING FOR $2 MILLION, WE 1521 00:59:28,320 --> 00:59:30,960 EXPECT 1 TO 2 AWARDS. 1522 00:59:30,960 --> 00:59:32,240 NIMH, NICHD AND NIDA SUPPORTED 1523 00:59:32,240 --> 00:59:32,840 THE LITE INITIATIVES IN THE 1524 00:59:32,840 --> 00:59:34,600 UNITED STATES IN THE PAST, 1525 00:59:34,600 --> 00:59:35,760 HOPING THEY WILL COME BACK IN 1526 00:59:35,760 --> 00:59:40,920 FOR THIS ONE AS WELL. 1527 00:59:40,920 --> 00:59:42,280 THE PROBLEM IS IN LATIN AMERICA 1528 00:59:42,280 --> 00:59:44,960 GLOBALLY THIS IS DATA FROM 2010 1529 00:59:44,960 --> 00:59:48,040 TO 2020, GLOBALLY THERE'S BEEN A 1530 00:59:48,040 --> 00:59:50,160 NICE DECLINE IN INCIDENCE OF 1531 00:59:50,160 --> 00:59:52,320 HIV, OVER TIME, OVER THAT TIME 1532 00:59:52,320 --> 00:59:55,040 PERIOD, BUT IN CONTRAST IN LATIN 1533 00:59:55,040 --> 00:59:57,120 AMERICA THERE'S BEEN INCREASE IN 1534 00:59:57,120 --> 00:59:58,880 HIV INCIDENCE, I WAS ABLE TO GET 1535 00:59:58,880 --> 01:00:01,240 THIS DATA HOT OFF THE PRESSES, 1536 01:00:01,240 --> 01:00:04,640 FOR GOING FROM 2010 TO 2022, 1537 01:00:04,640 --> 01:00:06,120 LET'S SEE IF I CAN USE THIS 1538 01:00:06,120 --> 01:00:08,480 MOUSE HERE. 1539 01:00:08,480 --> 01:00:08,680 YEAH. 1540 01:00:08,680 --> 01:00:11,360 WE CAN SEE IN TERMS OF NOW TWO 1541 01:00:11,360 --> 01:00:13,760 YEARS MORE, WE HAVE AN 8% 1542 01:00:13,760 --> 01:00:15,520 INCREASE IN HIV INCIDENCE IN 1543 01:00:15,520 --> 01:00:16,840 LATIN AMERICA. 1544 01:00:16,840 --> 01:00:19,560 AND THAT'S IN CONTRAST TO 38% 1545 01:00:19,560 --> 01:00:23,320 DECREASE IN GLOBAL, WHICH IS 1546 01:00:23,320 --> 01:00:24,960 DRIVEN BY THESE HETEROSEXUAL 1547 01:00:24,960 --> 01:00:26,920 EPIDEMICS IN AFRICA, REALLY 1548 01:00:26,920 --> 01:00:31,040 SUCCESSFUL REDUCTION IN HIV 1549 01:00:31,040 --> 01:00:31,320 INCIDENCE. 1550 01:00:31,320 --> 01:00:32,160 BUT THE LATIN AMERICAN EPIDEMIC 1551 01:00:32,160 --> 01:00:35,320 WHICH I WOULD POINT OUT HAS 1552 01:00:35,320 --> 01:00:37,280 TWICE AS MANY CASES AS EUROPE 1553 01:00:37,280 --> 01:00:39,920 AND NORTH AMERICA PUT TOGETHER, 1554 01:00:39,920 --> 01:00:44,280 IS REALLY A HOMOSEXUAL EPIDEMIC, 1555 01:00:44,280 --> 01:00:44,840 NOT HETEROSEXUAL. 1556 01:00:44,840 --> 01:00:47,360 I NEED TO POINT OUT A QUARTER OF 1557 01:00:47,360 --> 01:00:49,440 CASES IN LATIN AMERICA ARE 1558 01:00:49,440 --> 01:00:51,320 OCCURRING IN WOMEN NOT 1559 01:00:51,320 --> 01:00:53,080 HOMOSEXUAL, WHO ARE 1560 01:00:53,080 --> 01:00:53,840 HETEROSEXUAL, AND THREE-QUARTERS 1561 01:00:53,840 --> 01:00:57,440 IN MANY WHO HAVE SEX WITH MEN, 1562 01:00:57,440 --> 01:00:59,320 THAT'S ILLUSTRATED OVER HERE. 1563 01:00:59,320 --> 01:01:02,040 WE'RE ABOUT HALF OF THE CASES 1564 01:01:02,040 --> 01:01:04,120 AMONG MSM. 1565 01:01:04,120 --> 01:01:05,760 SMALL PROPORTION AMONG 1566 01:01:05,760 --> 01:01:07,280 TRANSGENDER WOMEN. 1567 01:01:07,280 --> 01:01:08,720 THERE'S RED GROUP, WHICH IS 1568 01:01:08,720 --> 01:01:09,840 PARTNERS OF THE AFFECTED GROUPS, 1569 01:01:09,840 --> 01:01:10,680 THIS IS THE WOMEN. 1570 01:01:10,680 --> 01:01:11,800 IT HAS TO BE THE WOMEN. 1571 01:01:11,800 --> 01:01:13,080 IF THEY WERE MEN THEY WOULD BE 1572 01:01:13,080 --> 01:01:16,160 OVER THERE IN THE GOLD SECTION. 1573 01:01:16,160 --> 01:01:18,160 AND SO WHAT'S HAPPENING IS 1574 01:01:18,160 --> 01:01:21,080 THERE'S MSM IN A HIGHLY 1575 01:01:21,080 --> 01:01:22,320 STIGMATIZED POPULATION WHO ARE 1576 01:01:22,320 --> 01:01:24,040 HAVING SEX WITH MEN AND ALSO 1577 01:01:24,040 --> 01:01:26,440 WITH WOMEN, AND THESE WOMEN ARE 1578 01:01:26,440 --> 01:01:27,440 BASICALLY UNAWARE OF THE FACT 1579 01:01:27,440 --> 01:01:28,160 THEY ARE AT RISK. 1580 01:01:28,160 --> 01:01:31,240 SO THIS IS A VERY HARD GROUP TO 1581 01:01:31,240 --> 01:01:32,360 FIND BECAUSE THEY DON'T EVEN 1582 01:01:32,360 --> 01:01:34,840 KNOW THEY ARE AT HIGH RISK OF 1583 01:01:34,840 --> 01:01:35,080 HIV. 1584 01:01:35,080 --> 01:01:38,240 BUT WE CAN FIND THIS GROUP. 1585 01:01:38,240 --> 01:01:41,600 SO THE QUESTION IS THE EPIDEMIC 1586 01:01:41,600 --> 01:01:42,560 LIKE LOOKS THE UNITED STATES 1587 01:01:42,560 --> 01:01:45,080 EXCEPT IN THE UNITED STATES 1588 01:01:45,080 --> 01:01:47,480 WOMEN CONSTITUTE 7% OF THE 1589 01:01:47,480 --> 01:01:48,280 ANNUAL CASES. 1590 01:01:48,280 --> 01:01:49,560 AND WE'VE BEEN SUCCESSFUL IN THE 1591 01:01:49,560 --> 01:01:51,960 UNITED STATES ROLLING OUT PrEP 1592 01:01:51,960 --> 01:01:56,040 AND ROLLING OUT THERAPY, GETTING 1593 01:01:56,040 --> 01:01:59,760 PEOPLE TO U EQUALS U, 1594 01:01:59,760 --> 01:02:00,360 UNDETECTABLE QUALITIES 1595 01:02:00,360 --> 01:02:01,520 UNTRANSMITTIBLE, THIS ISN'T 1596 01:02:01,520 --> 01:02:03,360 HAPPENING IN LATIN AMERICA. 1597 01:02:03,360 --> 01:02:05,200 PrEP STUDIES HAVE SHOWN 1598 01:02:05,200 --> 01:02:08,080 VIRTUALLY NONE OR ZERO USE IN 1599 01:02:08,080 --> 01:02:08,760 MOST COUNTRIES. 1600 01:02:08,760 --> 01:02:11,240 AND ALSO IN TERMS OF VIRAL 1601 01:02:11,240 --> 01:02:12,880 SUPPRESSION, IT'S BEEN SMALL 1602 01:02:12,880 --> 01:02:14,080 INCREASES OVER TIME, ABOUT 20% 1603 01:02:14,080 --> 01:02:16,400 OF PEOPLE LIVING WITH HIV DON'T 1604 01:02:16,400 --> 01:02:17,920 KNOW THEY HAVE HIV, ANOTHER 15% 1605 01:02:17,920 --> 01:02:20,680 KNOW THAT THEY HAVE IT BUT ARE 1606 01:02:20,680 --> 01:02:21,880 NOT ON THERAPY. 1607 01:02:21,880 --> 01:02:23,160 OVERALL 40% OF PEOPLE LIVING 1608 01:02:23,160 --> 01:02:28,400 WITH HIV ARE NOT SUPPRESSED. 1609 01:02:28,400 --> 01:02:33,240 SO, IN THE LIFE STUDIES, THIS IS 1610 01:02:33,240 --> 01:02:34,680 THE ORIGINAL THREE STUDIES, FOUR 1611 01:02:34,680 --> 01:02:36,960 FUNDED UNDER THE FIRST LITE. 1612 01:02:36,960 --> 01:02:39,280 GRANTEES THE SHOW SUCCESS IN 1613 01:02:39,280 --> 01:02:40,000 FINDING HIGHLY VULNERABLE MEN 1614 01:02:40,000 --> 01:02:43,640 WHO HAVE SEX WITH MEN, 1615 01:02:43,640 --> 01:02:45,200 TRANSGENDER WOMEN, USING THESE 1616 01:02:45,200 --> 01:02:47,360 GAY DATAING APPS WIDELY USED IN 1617 01:02:47,360 --> 01:02:52,080 THE UNITED STATES, ALSO WIDELY 1618 01:02:52,080 --> 01:02:53,040 USED IN LATIN AMERICA. 1619 01:02:53,040 --> 01:03:02,480 GRINDR IS THE NUMBER ONE. 1620 01:03:02,480 --> 01:03:05,840 GRANTEES IN LITE 1 THAT USE THE 1621 01:03:05,840 --> 01:03:09,440 DATING APPS TO ACCUMULATE THE 1622 01:03:09,440 --> 01:03:19,920 NUMBER OF PARTICIPANTS, FOR 1623 01:03:20,240 --> 01:03:22,920 EXAMPLE STUDYING 5,000 USING 1624 01:03:22,920 --> 01:03:25,680 GRINDR AND OTHER DATING APPS, 1625 01:03:25,680 --> 01:03:28,200 FOUND 11% THAT DEVELOPED OVER 1626 01:03:28,200 --> 01:03:32,120 FOUR YEARS, HIGHER INCIDENCE IN 1627 01:03:32,120 --> 01:03:37,720 BLACKS VERSUS LATINOS AND 1628 01:03:37,720 --> 01:03:39,760 WHITES, HALF OF THE 1629 01:03:39,760 --> 01:03:43,840 SEROCONVERSIONS WERE PEOPLE WHO 1630 01:03:43,840 --> 01:03:45,480 USE METH. 1631 01:03:45,480 --> 01:03:50,400 RENDINA USED THE GRINDR AND APPS 1632 01:03:50,400 --> 01:03:51,080 TO ACCUMULATE CASES, SCREENED 1633 01:03:51,080 --> 01:03:52,960 14,000 THROUGHOUT THE UNITED 1634 01:03:52,960 --> 01:03:55,880 STATES AND PUERTO RICO. 1635 01:03:55,880 --> 01:03:57,840 LOWER NUMBERS OF INFECTIONS, 1636 01:03:57,840 --> 01:04:01,480 STILL SUBSTANTIAL, SAME RACIAL 1637 01:04:01,480 --> 01:04:04,080 DIFFERENCES. 1638 01:04:04,080 --> 01:04:05,840 THE WIRTZ AND REISNER STUDY USED 1639 01:04:05,840 --> 01:04:08,480 CLINICS FOR HALF OF SUBJECTS, ON 1640 01:04:08,480 --> 01:04:10,880 THE EAST COAST AND IN THE SOUTH. 1641 01:04:10,880 --> 01:04:14,360 SOCIAL MEDIA BUT NOT THE DATING 1642 01:04:14,360 --> 01:04:17,440 APPS, FACEBOOK AND OTHER ONES, 1643 01:04:17,440 --> 01:04:19,840 LOWER NUMBER OF HIV 1644 01:04:19,840 --> 01:04:20,400 SEROCONVERSIONS, SHOWS 1645 01:04:20,400 --> 01:04:25,120 IMPORTANCE OF THESE GAY DATING 1646 01:04:25,120 --> 01:04:27,720 APPS IN TERMS OF FINDING HIGHLY 1647 01:04:27,720 --> 01:04:28,960 VULNERABLE PEOPLE, AND IT MAKES 1648 01:04:28,960 --> 01:04:29,400 SENSE. 1649 01:04:29,400 --> 01:04:31,120 YOU HAVE SOMETHING ON YOUR PHONE 1650 01:04:31,120 --> 01:04:34,200 THAT CAN FIND YOUR DATING 1651 01:04:34,200 --> 01:04:37,280 PARTNER FOR THE NIGHT AS EASILY 1652 01:04:37,280 --> 01:04:38,840 AS ORDERING PIZZA, IT MAKES 1653 01:04:38,840 --> 01:04:39,840 SINCE THIS IS FINDING PEOPLE 1654 01:04:39,840 --> 01:04:41,680 VERY MUCH AT RISK. 1655 01:04:41,680 --> 01:04:43,000 IN TERMS OF PAPERS THAT CAME OUT 1656 01:04:43,000 --> 01:04:45,160 OF THE FIRST GROUP OF LITE 1657 01:04:45,160 --> 01:04:48,240 STUDIES, I PLUGGED IN THE GRANT 1658 01:04:48,240 --> 01:04:50,120 NUMBERS FOR THREE GRANTS INTO 1659 01:04:50,120 --> 01:04:54,040 PubMed, AND PULLED OUT THE 1660 01:04:54,040 --> 01:04:57,560 PAPERS THAT WERE -- GENERATED, A 1661 01:04:57,560 --> 01:05:01,280 HOLD OF 86 IN THE FIVE-YEAR 1662 01:05:01,280 --> 01:05:02,600 PERIOD. 1663 01:05:02,600 --> 01:05:07,080 HERE WE'RE COMPARING PEOPLE WHO 1664 01:05:07,080 --> 01:05:10,560 SEROCONVERT TO THOSE WHO DON'T, 1665 01:05:10,560 --> 01:05:11,680 JUST THESE TWO, METH USE BY 1666 01:05:11,680 --> 01:05:13,960 GROVE AND THE OTHER IN THE 1667 01:05:13,960 --> 01:05:14,800 TRANSGENDER POPULATION, MAKES 1668 01:05:14,800 --> 01:05:16,600 SENSE BECAUSE OF COURSE YOU 1669 01:05:16,600 --> 01:05:18,440 CAN'T WAIT TO PUBLISH UNTIL ALL 1670 01:05:18,440 --> 01:05:19,480 YOU'VE ACCUMULATED ALL YOUR 1671 01:05:19,480 --> 01:05:20,960 CASES, THEY HAVE TO BE WORKING 1672 01:05:20,960 --> 01:05:26,680 FROM DAY ONE TO BE RE-FUNDED. 1673 01:05:26,680 --> 01:05:29,760 I THINK WHAT WAS KEY WAS THAT 1674 01:05:29,760 --> 01:05:31,720 USING THESE SOCIAL MEDIA AND 1675 01:05:31,720 --> 01:05:33,680 REMOTE METHODS WITH VERY LARGE 1676 01:05:33,680 --> 01:05:37,200 COHORTS, WORKING ALMOST IN REAL 1677 01:05:37,200 --> 01:05:38,960 TIME, I MEAN PARTICIPANTS ARE AN 1678 01:05:38,960 --> 01:05:40,840 E-MAIL AWAY FROM THE 1679 01:05:40,840 --> 01:05:42,240 INVESTIGATORS, AND SO THEY DID 1680 01:05:42,240 --> 01:05:44,760 QUITE A FEW STUDIES ON PrEP, 1681 01:05:44,760 --> 01:05:46,400 23% OF PAPERS DEALT WITH PrEP 1682 01:05:46,400 --> 01:05:48,240 INCLUDING THIS ONE THAT DEALT 1683 01:05:48,240 --> 01:05:51,200 WITH EFFECT ON PrEP USE IN THE 1684 01:05:51,200 --> 01:05:59,840 UNITED STATES THAT SWITCHED FROM 1685 01:05:59,840 --> 01:06:01,240 GILEAD FROM AND THERE WERE 1686 01:06:01,240 --> 01:06:03,120 LAWSUITS THAT SAID THEY ENGAGED 1687 01:06:03,120 --> 01:06:04,120 PEOPLE BY WITHHOLDING, A 1688 01:06:04,120 --> 01:06:06,000 CHILLING EFFECT ON USE OF PrEP 1689 01:06:06,000 --> 01:06:07,720 WHERE PEOPLE STOPPED USING IT OR 1690 01:06:07,720 --> 01:06:09,080 THEY DECIDED NOT TO USE IT 1691 01:06:09,080 --> 01:06:11,440 BECAUSE THEY THOUGHT IT WAS 1692 01:06:11,440 --> 01:06:13,760 DANGEROUS, NOT MANY PAPERS ON 1693 01:06:13,760 --> 01:06:14,640 TREATMENTS BUT LITE STUDIES, 1694 01:06:14,640 --> 01:06:17,200 THAT WAS NOT A FACTOR. 1695 01:06:17,200 --> 01:06:19,800 THEY WEREN'T FUNDED TO DO THAT. 1696 01:06:19,800 --> 01:06:21,520 AND I THINK THE ABILITY TO WORK 1697 01:06:21,520 --> 01:06:24,360 IN REAL TIME IS SHOWN IN THEIR 1698 01:06:24,360 --> 01:06:26,800 STUDIES OF COVID WHICH 41% OF 1699 01:06:26,800 --> 01:06:30,080 PAPERS DEALT WITH THE COVID 1700 01:06:30,080 --> 01:06:30,760 EPIDEMIC, BECAUSE THEY COULD 1701 01:06:30,760 --> 01:06:33,480 PIVOT ON A DIME AND NOW SWITCH 1702 01:06:33,480 --> 01:06:37,640 WHEN WE HAD THE PANDEMIC, BOTH 1703 01:06:37,640 --> 01:06:43,800 THE GROVE AND WIRTZ REISNER WERE 1704 01:06:43,800 --> 01:06:46,400 SUPPLEMENTED TO WORK WITH COVID, 1705 01:06:46,400 --> 01:06:50,120 AND NOW HE'S WORKING WITH Mpox 1706 01:06:50,120 --> 01:06:51,760 IN GAY POPULATIONS, LETS THEM 1707 01:06:51,760 --> 01:06:52,960 LOOK INTO THE WEEDS IN TERMS OF 1708 01:06:52,960 --> 01:06:54,280 YOU HAVE A LARGE NUMBER OF 1709 01:06:54,280 --> 01:06:57,240 PEOPLE AT HIGH RISK OF HIV AND 1710 01:06:57,240 --> 01:07:01,520 YOU CAN LOOK AT, YOU KNOW, 1711 01:07:01,520 --> 01:07:03,080 SUICIDE AND WHATEVER, THE LATIN 1712 01:07:03,080 --> 01:07:04,360 AMERICA INVESTIGATORS WILL NOW 1713 01:07:04,360 --> 01:07:08,560 BE ABLE TO FOCUS ON TREATMENT 1714 01:07:08,560 --> 01:07:10,200 AND CONDUCT PREVENTION OR 1715 01:07:10,200 --> 01:07:10,960 BEHAVIORAL CLINICAL TRIALS, 1716 01:07:10,960 --> 01:07:21,480 THOSE WERE NOT ALLOWED UNDER 1717 01:07:24,800 --> 01:07:26,600 FIRST LITE STUDIES. 1718 01:07:26,600 --> 01:07:28,240 SO ARE THESE DATING APPS 1719 01:07:28,240 --> 01:07:29,440 AVAILABLE IN LATIN AMERICA? 1720 01:07:29,440 --> 01:07:32,960 AND THEY ARE. 1721 01:07:32,960 --> 01:07:36,240 I MEAN, THIS STUDY ENROLLED 1722 01:07:36,240 --> 01:07:37,560 56,000 PEOPLE, 18 COUNTRIES. 1723 01:07:37,560 --> 01:07:39,760 AND THEY HAVE BEEN ABLE TO 1724 01:07:39,760 --> 01:07:41,720 ENROLL SEXUAL AND GENDER 1725 01:07:41,720 --> 01:07:45,320 MINORITIES, JUST HAVE BEEN 1726 01:07:45,320 --> 01:07:47,840 SUCCESSFULLY USED, ALSO IN LATIN 1727 01:07:47,840 --> 01:07:48,160 AMERICA. 1728 01:07:48,160 --> 01:07:50,640 WHAT ARE THE QUESTIONS THEY CAN 1729 01:07:50,640 --> 01:07:51,960 ANSWER, PREVENTION QUESTIONS? 1730 01:07:51,960 --> 01:07:53,720 IT'S REALLY BASICALLY WHAT ARE 1731 01:07:53,720 --> 01:07:57,560 THE SUBGROUPS OF MSM AND 1732 01:07:57,560 --> 01:07:59,760 TRANSGENDER PEOPLE WITH HIGHEST 1733 01:07:59,760 --> 01:08:01,200 VULNERABILITY, ROLE OF SUBSTANCE 1734 01:08:01,200 --> 01:08:02,680 USE, IS THAT A FACTOR IN LATIN 1735 01:08:02,680 --> 01:08:06,120 AMERICA, WE DON'T KNOW. 1736 01:08:06,120 --> 01:08:08,520 WHAT ABOUT ALCOHOL? 1737 01:08:08,520 --> 01:08:12,160 DO SPECIFIC PRACTICES INCREASE 1738 01:08:12,160 --> 01:08:13,880 VULNERABLE, CONDOM USE, WHAT 1739 01:08:13,880 --> 01:08:18,680 ABOUT SEX WORK, HIV INCIDENCE IN 1740 01:08:18,680 --> 01:08:20,680 INCARCERATED POPULATIONS, HOW 1741 01:08:20,680 --> 01:08:21,640 ABOUT CAB-LA IMPACT USE? 1742 01:08:21,640 --> 01:08:24,720 WHAT IS LENGTH OF TIME FROM HIV 1743 01:08:24,720 --> 01:08:26,800 DIAGNOSIS TO VIRAL SUPPRESSION? 1744 01:08:26,800 --> 01:08:29,400 WHY ARE SOME MSM AND TRANSGENDER 1745 01:08:29,400 --> 01:08:30,840 PEOPLE LESS LIKELY TO BE 1746 01:08:30,840 --> 01:08:32,360 RETAINED IN CARE AND SUPPRESSED, 1747 01:08:32,360 --> 01:08:34,560 WHAT'S THE ROLE OF ALCOHOL AND 1748 01:08:34,560 --> 01:08:36,880 SUBSTANCE USE, WHAT ARE 1749 01:08:36,880 --> 01:08:37,960 STRUCTURAL FACTORS ASSOCIATED 1750 01:08:37,960 --> 01:08:42,680 WITH POOR RETENTION AND VIRAL 1751 01:08:42,680 --> 01:08:45,760 SUPPRESSION, WHAT'S EFFECT OF 1752 01:08:45,760 --> 01:08:53,080 COST, OF POVERTY, HOW CAN NEW 1753 01:08:53,080 --> 01:08:54,440 AND REVISED TREATMENT PROGRAMS 1754 01:08:54,440 --> 01:09:00,640 IMPROVE RETENTION AND VIRAL 1755 01:09:00,640 --> 01:09:01,000 SUPPRESSION. 1756 01:09:01,000 --> 01:09:02,480 THE RFA REQUIREMENTS ARE 1757 01:09:02,480 --> 01:09:04,400 SIMILAR, REQUIRED TO DEVELOP 1758 01:09:04,400 --> 01:09:09,320 LARGE, MORE THAN 5,000 PEOPLE, 1759 01:09:09,320 --> 01:09:10,480 COHORTS, CONTACTED REMOTELY AND 1760 01:09:10,480 --> 01:09:13,760 THEY HAVE HIGHLY VULNERABLE TO 1761 01:09:13,760 --> 01:09:16,280 HIV, IT'S LIKELY THAT MSM OR 1762 01:09:16,280 --> 01:09:17,560 TRANSGENDER PEOPLE WILL BE 1763 01:09:17,560 --> 01:09:19,120 STUDIES BUT THIS COULD FUND 1764 01:09:19,120 --> 01:09:20,120 STUDIES OF COMMERCIAL SEX 1765 01:09:20,120 --> 01:09:21,520 WORKERS AND LOOK AT WOMEN BUT 1766 01:09:21,520 --> 01:09:24,160 THEY WOULD HAVE TO FIND A WAY TO 1767 01:09:24,160 --> 01:09:25,440 FIND LARGE NUMBERS AND FIND 1768 01:09:25,440 --> 01:09:27,640 THOSE MOST AT RISK OF HIV. 1769 01:09:27,640 --> 01:09:30,200 THE GRANTEES WOULD BE REQUIRED 1770 01:09:30,200 --> 01:09:33,480 TO DEVELOP INNOVATIVE METHODS OF 1771 01:09:33,480 --> 01:09:34,880 DIGITAL ENROLLMENT, REMOTE 1772 01:09:34,880 --> 01:09:36,520 TESTING AND FOLLOW-UP, AS IT'S 1773 01:09:36,520 --> 01:09:38,080 MILESTONE DESIGNED WHERE THEY 1774 01:09:38,080 --> 01:09:42,440 HAVE TO MEET INITIAL MILESTONES 1775 01:09:42,440 --> 01:09:44,840 FOR RETENTION AND ACCUMULATING 1776 01:09:44,840 --> 01:09:46,600 PARTICIPANTS AND HIGH RISK IN 1777 01:09:46,600 --> 01:09:48,760 TERMS OF SEROCONVERSION TO GET 1778 01:09:48,760 --> 01:09:52,240 THE SECOND PHASE OF FUNDING, 1779 01:09:52,240 --> 01:09:54,600 AFTER TWO YEARS TO GET THE LAST 1780 01:09:54,600 --> 01:09:55,920 THREE YEARS. 1781 01:09:55,920 --> 01:09:57,640 GRANTEES WILL BE REQUIRED TO 1782 01:09:57,640 --> 01:09:59,080 REFER PARTICIPANTS TESTING HIV 1783 01:09:59,080 --> 01:10:01,160 POSITIVE TO CARE AND CONTINUE 1784 01:10:01,160 --> 01:10:02,280 FOLLOW-UP TO DOCUMENT RETENTION 1785 01:10:02,280 --> 01:10:05,320 AND CARE IN VIRAL SUPPRESSION. 1786 01:10:05,320 --> 01:10:10,360 THIS IS NOT DONE IN THE ORIGINAL 1787 01:10:10,360 --> 01:10:13,720 LITE STUDIES, AND CONDUCT 1788 01:10:13,720 --> 01:10:15,720 EPIDEMIOLOGY STUDIES. 1789 01:10:15,720 --> 01:10:18,320 REVIEWERS WERE D'AQUILA AND 1790 01:10:18,320 --> 01:10:19,400 SHACKLEFORD, THIS IS CRITICALLY 1791 01:10:19,400 --> 01:10:21,720 IMPORTANT TO BEGIN STUDY OF HIV 1792 01:10:21,720 --> 01:10:23,520 AND VIREMIA RISK GIVEN TRENDS 1793 01:10:23,520 --> 01:10:25,560 ARE GOING THE WRONG WAY, LITE 1794 01:10:25,560 --> 01:10:28,200 APPROACH IS SMART GIVEN EARLIER 1795 01:10:28,200 --> 01:10:28,600 SUCCESS. 1796 01:10:28,600 --> 01:10:30,240 THEY WOULD NOTE ADD REQUIREMENT 1797 01:10:30,240 --> 01:10:32,200 FOR ENROLLING SPECIFIC RACES AND 1798 01:10:32,200 --> 01:10:33,960 ETHNIC GROUPS BUT INVESTIGATORS 1799 01:10:33,960 --> 01:10:35,720 SHOULD ENROLL ACROSS RACES 1800 01:10:35,720 --> 01:10:39,040 INCLUDING INDIGENOUS AND BLACK 1801 01:10:39,040 --> 01:10:39,840 PARTICIPANTS. 1802 01:10:39,840 --> 01:10:41,640 THE AMERICAN LITES REQUIRED 50% 1803 01:10:41,640 --> 01:10:43,840 MINORITY, AND THAT'S NOT BEING 1804 01:10:43,840 --> 01:10:44,560 DONE HERE. 1805 01:10:44,560 --> 01:10:47,960 BUT WE AGREE IT'S A GOOD IDEA, 1806 01:10:47,960 --> 01:10:50,800 AT LEAST TO ENCOURAGE PEOPLE, 1807 01:10:50,800 --> 01:10:52,920 EVEN REQUIRE INVESTIGATORS TO 1808 01:10:52,920 --> 01:10:55,200 ENROLL ACROSS RACES, ALSO ACROSS 1809 01:10:55,200 --> 01:10:57,080 SES STATUS, THAT HAS BEEN SHOWN 1810 01:10:57,080 --> 01:10:59,240 THAT LOWER INCOME IS ASSOCIATED 1811 01:10:59,240 --> 01:11:03,080 WITH HIGHER RISKS OF HIV. 1812 01:11:03,080 --> 01:11:05,400 IT'S IMPORTANT TO REQUIRE 1813 01:11:05,400 --> 01:11:06,360 IN-COUNTRY INVESTIGATOR TO BRING 1814 01:11:06,360 --> 01:11:07,880 KNOWLEDGE OF CULTURE AND LOCAL 1815 01:11:07,880 --> 01:11:10,200 RISK GROUPS AND MEDICAL CARE 1816 01:11:10,200 --> 01:11:15,320 ACCESS IN INDIGENOUS PEOPLES. 1817 01:11:15,320 --> 01:11:17,880 REALLY IT WOULD BE NICE IF THE 1818 01:11:17,880 --> 01:11:19,360 INVESTIGATORS SPOKE SPANISH OR 1819 01:11:19,360 --> 01:11:21,680 PORTUGUESE, AND WE AGREE WITH 1820 01:11:21,680 --> 01:11:25,600 THE REVIEWERS AND RFA WILL 1821 01:11:25,600 --> 01:11:26,280 REQUIRE IN-COUNTRY 1822 01:11:26,280 --> 01:11:32,280 CO-INVESTIGATORS WHERE 1823 01:11:32,280 --> 01:11:33,720 PARTICIPANTS ARE RECREATED. 1824 01:11:33,720 --> 01:11:34,160 SORRY. 1825 01:11:34,160 --> 01:11:35,800 CONSIDER IF THERE ARE 1826 01:11:35,800 --> 01:11:37,880 DIFFERENCES ACROSS COUNTRIES IN 1827 01:11:37,880 --> 01:11:43,240 PrEP ROLLOUT, ART ACCESS, ART 1828 01:11:43,240 --> 01:11:45,960 SUPPRESSION, OF VIREMIA SET THE 1829 01:11:45,960 --> 01:11:47,600 STAGE FOR STUDYING CORRELATES OF 1830 01:11:47,600 --> 01:11:49,880 BETTER SUCCESS, WE CAN MAKE THIS 1831 01:11:49,880 --> 01:11:51,760 A REVIEW CRITERIA, APPLICANTS 1832 01:11:51,760 --> 01:11:54,000 REQUIRED TO JUSTIFY INCLUDING 1833 01:11:54,000 --> 01:11:57,120 PARTICIPANTS FROM COUNTRIES 1834 01:11:57,120 --> 01:11:59,320 BASED ON HIV INCIDENCE, PrEP 1835 01:11:59,320 --> 01:12:00,840 ROLLOUT, ANOTHER COMMENT IF 1836 01:12:00,840 --> 01:12:02,720 SMARTPHONE APPS AND/OR CELL DATA 1837 01:12:02,720 --> 01:12:04,000 ACCESS ARE TO BE USED ENSURE 1838 01:12:04,000 --> 01:12:06,320 THERE ARE WAYS BUILT INTO THE 1839 01:12:06,320 --> 01:12:07,960 STUDY PLAN TO ENABLE 1840 01:12:07,960 --> 01:12:09,680 PARTICIPANTS TO MAINTAIN 1841 01:12:09,680 --> 01:12:12,760 CONSISTENT SMARTPHONE DATA PLAN 1842 01:12:12,760 --> 01:12:13,520 ACCESS, ALTERNATIVE TECHNOLOGY 1843 01:12:13,520 --> 01:12:17,680 USING DUMB PHONE, I LOVE THAT, 1844 01:12:17,680 --> 01:12:20,440 ACCESSIBLE TEXTING MIGHT BE 1845 01:12:20,440 --> 01:12:21,160 CONSIDERED. 1846 01:12:21,160 --> 01:12:24,280 LEVELS OF SMARTPHONE OWNERSHIP 1847 01:12:24,280 --> 01:12:28,760 ARE HIGH, THE USE OF GAY DATING 1848 01:12:28,760 --> 01:12:31,560 APPS HAS WORKED PREVIOUSLY. 1849 01:12:31,560 --> 01:12:32,560 THOSE WERE CROSS-SECTIONAL 1850 01:12:32,560 --> 01:12:33,360 STUDIES. 1851 01:12:33,360 --> 01:12:35,200 LONGITUDINAL STUDIES WILL BE 1852 01:12:35,200 --> 01:12:36,960 HARDER, INVESTIGATORS SHOULD 1853 01:12:36,960 --> 01:12:39,360 OUTLINE PLANS AND ALTERNATE 1854 01:12:39,360 --> 01:12:41,840 PLANS IF ORIGINAL APPROACH 1855 01:12:41,840 --> 01:12:43,200 FAILS. 1856 01:12:43,200 --> 01:12:47,040 RETENTION IS UH3 MILESTONE. 1857 01:12:47,040 --> 01:12:52,720 ANOTHER COMMENT WAS THAT UG3/UH3 1858 01:12:52,720 --> 01:12:55,680 MECHANISM IS A PLUS, FLEXIBILITY 1859 01:12:55,680 --> 01:12:57,520 IS ENCOURAGED TO ADAPT RETENTION 1860 01:12:57,520 --> 01:12:57,960 STRATEGIES. 1861 01:12:57,960 --> 01:12:59,320 NIH WILL NEGOTIATE MILESTONES 1862 01:12:59,320 --> 01:13:02,120 BEFORE FUNDING TO ENSURE THEY 1863 01:13:02,120 --> 01:13:04,320 ARE REASONABLE. 1864 01:13:04,320 --> 01:13:05,720 UG3/UH3 MECHANISM ALLOWS NIH TO 1865 01:13:05,720 --> 01:13:07,480 FUND INNOVATION BUT NOT BE 1866 01:13:07,480 --> 01:13:09,680 OBLIGATED TO A FAILING PROJECT. 1867 01:13:09,680 --> 01:13:10,880 LITE EXPERIENCE HAS BEEN THAT AT 1868 01:13:10,880 --> 01:13:13,600 THE NIH PROGRAM OFFICERS CAN 1869 01:13:13,600 --> 01:13:15,040 WORK WITH THE GRANTEES AND -- I 1870 01:13:15,040 --> 01:13:16,600 MEAN PROGRAM OFFICERS FROM 1871 01:13:16,600 --> 01:13:18,520 CO-FUNDING INSTITUTES CAN WORK 1872 01:13:18,520 --> 01:13:21,040 WITH GRANTEES TO MAKE MILESTONES 1873 01:13:21,040 --> 01:13:23,440 FEASIBLE AND DURING INITIAL 1874 01:13:23,440 --> 01:13:24,760 PHASE COLLABORATION BETWEEN 1875 01:13:24,760 --> 01:13:25,960 INVESTIGATORS AND THE NIH STAFF 1876 01:13:25,960 --> 01:13:29,480 CAN GUIDE THEM TO SWITCH 1877 01:13:29,480 --> 01:13:31,680 APPROACHES QUICKLY FOR SUCCESS. 1878 01:13:31,680 --> 01:13:34,520 AND THEN THE FINAL COMMENT ON 1879 01:13:34,520 --> 01:13:37,480 EVALUATING -- SORRY ABOUT THAT. 1880 01:13:37,480 --> 01:13:39,720 EVALUATING LONG ACTING PrEP IS 1881 01:13:39,720 --> 01:13:40,520 ENCOURAGED, GIVEN STUDIES WILL 1882 01:13:40,520 --> 01:13:41,720 BE STARTING CLOSE TO WHEN THIS 1883 01:13:41,720 --> 01:13:44,360 ROLLS OUT AND THERE MAY BE 1884 01:13:44,360 --> 01:13:45,200 DIFFERENCES IN ACCESS/COST 1885 01:13:45,200 --> 01:13:46,920 COMPARED TO UNITED STATES AND 1886 01:13:46,920 --> 01:13:48,400 MAYBE ACROSS LATIN AMERICA. 1887 01:13:48,400 --> 01:13:49,840 SO WE ABSOLUTELY WILL DO THIS AS 1888 01:13:49,840 --> 01:13:52,280 MUCH AS WE CAN ENCOURAGE STUDIES 1889 01:13:52,280 --> 01:13:54,240 OF CAB-LA WE WILL DO IT. 1890 01:13:54,240 --> 01:13:59,800 ONE PROBLEM THAT THIS MAP SHOWS 1891 01:13:59,800 --> 01:14:01,560 COUNTRIES, 90 COUNTRIES AGREED 1892 01:14:01,560 --> 01:14:03,880 TO PROVIDE LOWER COST PrEP 1893 01:14:03,880 --> 01:14:07,920 FOR, IN TERMS OF LONG ACTING 1894 01:14:07,920 --> 01:14:08,120 CAB-LA. 1895 01:14:08,120 --> 01:14:09,480 YOU CAN SEE ONLY THREE COUNTRIES 1896 01:14:09,480 --> 01:14:14,480 IN SOUTH AMERICA AND CENTRAL 1897 01:14:14,480 --> 01:14:21,000 AMERICA ARE INCLUDED, BOLIVIA, 1898 01:14:21,000 --> 01:14:21,440 HONDURAS, EL SALVADOR. 1899 01:14:21,440 --> 01:14:23,880 $23,000 IN THE UNITED STATES, 1900 01:14:23,880 --> 01:14:26,080 HOPEFULLY WON'T BE FUNDED UNTIL 1901 01:14:26,080 --> 01:14:29,040 2025 TO 2030, HOPEFULLY COSTS 1902 01:14:29,040 --> 01:14:33,720 WILL COME DOWN, AS THESE NEW 1903 01:14:33,720 --> 01:14:34,720 LONG-ACTING MEDICINES ARE 1904 01:14:34,720 --> 01:14:35,080 APPROVED. 1905 01:14:35,080 --> 01:14:37,480 I'LL STOP HERE SINCE I'VE 1906 01:14:37,480 --> 01:14:39,960 ALREADY TALKED ABOUT THIS, AND 1907 01:14:39,960 --> 01:14:40,320 TAKE QUESTIONS. 1908 01:14:40,320 --> 01:14:42,840 >> THANK YOU VERY MUCH. 1909 01:14:42,840 --> 01:14:46,000 NOW OPEN FOR QUESTIONS. 1910 01:14:46,000 --> 01:14:52,680 1911 01:14:52,680 --> 01:14:54,640 >> AUDREY PETTYFOR, UNC. 1912 01:14:54,640 --> 01:14:58,400 I HAVE A DOCTORAL STUDENT AT 1913 01:14:58,400 --> 01:15:00,800 UNC, IN THE LITE I COHORT, ONE 1914 01:15:00,800 --> 01:15:03,960 OF THEM, LOOKING AT STATE LEVEL 1915 01:15:03,960 --> 01:15:06,480 DISCRIMINATORY POLICIES, HOW 1916 01:15:06,480 --> 01:15:07,720 IT'S IMPACTED PrEP UPTAKE, 1917 01:15:07,720 --> 01:15:08,480 THERE'S MORE COMING PROBABLY 1918 01:15:08,480 --> 01:15:11,480 FROM EVEN THE FIRST ONE AND I 1919 01:15:11,480 --> 01:15:13,200 THINK THE GEOGRAPHIC DIVERSITY 1920 01:15:13,200 --> 01:15:14,640 THAT THE ONLINE PLATFORM OFFERS 1921 01:15:14,640 --> 01:15:18,560 DOES ALLOW FOR SORT OF 1922 01:15:18,560 --> 01:15:21,440 MULTI-LEVEL STATE LEVEL, AND I 1923 01:15:21,440 --> 01:15:22,760 WONDER IN LATIN AMERICA SIMILAR 1924 01:15:22,760 --> 01:15:26,000 THINGS WITH THE RISE OF 1925 01:15:26,000 --> 01:15:27,880 DISCRIMINATORY POLICIES, WITH 1926 01:15:27,880 --> 01:15:28,840 THE POLITICAL CLIMATE GLOBALLY 1927 01:15:28,840 --> 01:15:29,360 NOW. 1928 01:15:29,360 --> 01:15:31,200 I THINK IT'S A REALLY IMPORTANT 1929 01:15:31,200 --> 01:15:34,800 PLATFORM TO MEASURE AND TRACK 1930 01:15:34,800 --> 01:15:36,080 HOW THAT'S IMPACTING PREVENTION 1931 01:15:36,080 --> 01:15:37,280 AND ACCESS TO CARE. 1932 01:15:37,280 --> 01:15:40,600 >> IT ALLOWS, IF THERE'S A SMALL 1933 01:15:40,600 --> 01:15:43,760 SUBGROUP, ALLOWS PEOPLE TO 1934 01:15:43,760 --> 01:15:45,880 ACCUMULATE ENOUGH PARTICIPANTS, 1935 01:15:45,880 --> 01:15:47,080 FOR EXAMPLE THE WOMEN'S STUDY TO 1936 01:15:47,080 --> 01:15:49,680 GO WIDE TO HAVE ENOUGH PEOPLE IN 1937 01:15:49,680 --> 01:15:53,080 THE COHORT, REALLY AN ADVANTAGE. 1938 01:15:53,080 --> 01:15:54,840 AND NO LIMITS FOR GEOGRAPHY 1939 01:15:54,840 --> 01:15:57,040 BECAUSE EVERYTHING IS DONE 1940 01:15:57,040 --> 01:15:57,320 REMOTELY. 1941 01:15:57,320 --> 01:15:59,160 >> I THINK THIS IS GREAT, OTHER 1942 01:15:59,160 --> 01:16:01,520 ONES IN THE UNITED STATES HAVE 1943 01:16:01,520 --> 01:16:02,840 BEEN SUCCESSFUL BUT MY QUESTION 1944 01:16:02,840 --> 01:16:06,560 WAS IT'S ALMOST LIKE YOU'RE 1945 01:16:06,560 --> 01:16:08,120 COMBINING LITE AND LITE-VS, THIS 1946 01:16:08,120 --> 01:16:10,200 WOULD BE ACROSS THE ENTIRE 1947 01:16:10,200 --> 01:16:12,160 SPECTRUM, EITHER NEGATIVE OR 1948 01:16:12,160 --> 01:16:17,160 PEOPLE LIVING WITH HIV, SEEMS 1949 01:16:17,160 --> 01:16:18,440 LIKE -- WELL, MOBILE VENUES, BUT 1950 01:16:18,440 --> 01:16:19,720 SEEMS LIKE THIS COULD BE HARD 1951 01:16:19,720 --> 01:16:22,200 BECAUSE YOU HAVE TO LINK THEM 1952 01:16:22,200 --> 01:16:23,040 INTO CARE DIFFERENTLY. 1953 01:16:23,040 --> 01:16:26,280 >> BUT THEY WILL HAVE PEOPLE WHO 1954 01:16:26,280 --> 01:16:26,880 SEROCONVERT, CONTINUING TO 1955 01:16:26,880 --> 01:16:27,920 FOLLOW UP TO SEE WHAT HAPPENS, 1956 01:16:27,920 --> 01:16:29,960 HOW LONG IT TAKES TO GET INTO 1957 01:16:29,960 --> 01:16:32,520 CARE, FIND A WAY TO MEASURE 1958 01:16:32,520 --> 01:16:33,800 VIRAL SUPPRESSION REMOTELY. 1959 01:16:33,800 --> 01:16:37,400 AND THEN TALK ABOUT WHAT THE -- 1960 01:16:37,400 --> 01:16:39,280 THEY WILL HAVE INCIDENT CASES TO 1961 01:16:39,280 --> 01:16:41,480 FOLLOW OVER TIME. 1962 01:16:41,480 --> 01:16:42,680 PRETTY POWERFUL DESIGN. 1963 01:16:42,680 --> 01:16:44,440 AND WE JUST FELT THAT THE 1964 01:16:44,440 --> 01:16:46,280 PROBLEM IN LATIN AMERICA IS NOT 1965 01:16:46,280 --> 01:16:47,360 JUST PREVENTION, IT'S REALLY 1966 01:16:47,360 --> 01:16:48,720 TREATMENT AS WELL. 1967 01:16:48,720 --> 01:16:51,800 I SHOWED THAT SLIDE THAT WE NEED 1968 01:16:51,800 --> 01:16:53,880 TO ADDRESS BOTH IF IT'S 1969 01:16:53,880 --> 01:16:54,120 POSSIBLE. 1970 01:16:54,120 --> 01:17:02,400 AND I THINK IT WILL. 1971 01:17:02,400 --> 01:17:04,480 >> OTHER QUESTIONS? 1972 01:17:04,480 --> 01:17:11,960 >> LOUIS SHACKLEFORD, HVCN. 1973 01:17:11,960 --> 01:17:13,400 LEVEL OF REPRESENTATION IS 1974 01:17:13,400 --> 01:17:14,600 AMAZING, HAPPY I GOT CHANCE TO 1975 01:17:14,600 --> 01:17:18,080 BE PART OF IT IN TERMS OF 1976 01:17:18,080 --> 01:17:20,280 REVIEWING AND IT'S AN AMAZING 1977 01:17:20,280 --> 01:17:20,520 PROGRAM. 1978 01:17:20,520 --> 01:17:22,480 I REALLY APPRECIATE YOU BRINGING 1979 01:17:22,480 --> 01:17:23,080 THIS TO THE TABLE. 1980 01:17:23,080 --> 01:17:23,560 >> THANK YOU. 1981 01:17:23,560 --> 01:17:27,600 THANK YOU FOR BEING A REVIEWER. 1982 01:17:27,600 --> 01:17:29,720 APPRECIATE YOUR COMMENTS. 1983 01:17:29,720 --> 01:17:32,200 >> THIS IS RICH D'AQUILA, I'D 1984 01:17:32,200 --> 01:17:34,840 LIKE TO SECOND WHAT LOUIS SAID. 1985 01:17:34,840 --> 01:17:36,360 THANK YOU FOR BEING RESPONSIVE 1986 01:17:36,360 --> 01:17:38,720 TO OUR COMMENTS AS WELL, GERALD. 1987 01:17:38,720 --> 01:17:43,400 >> OH, THAT'S RICHARD. 1988 01:17:43,400 --> 01:17:45,320 OKAY, THANK YOU. 1989 01:17:45,320 --> 01:17:49,960 >> ONE COMMENT, WHETHER YOU 1990 01:17:49,960 --> 01:17:51,160 CONSIDERED MIGRANT POPULATIONS 1991 01:17:51,160 --> 01:17:51,400 AS WELL? 1992 01:17:51,400 --> 01:17:53,320 >> YOU MEAN IN THE UNITED 1993 01:17:53,320 --> 01:17:53,560 STATES? 1994 01:17:53,560 --> 01:17:55,360 >> NO, IN LATIN AMERICA. 1995 01:17:55,360 --> 01:17:56,320 >> WITHIN LATIN AMERICA? 1996 01:17:56,320 --> 01:17:56,840 >> YEAH. 1997 01:17:56,840 --> 01:18:02,000 >> I MEAN, IT'S UP TO THE 1998 01:18:02,000 --> 01:18:03,160 INVESTIGATORS BUT THEY CAN FIND 1999 01:18:03,160 --> 01:18:04,280 THEM. 2000 01:18:04,280 --> 01:18:05,280 THEY HAVE CELL PHONES. 2001 01:18:05,280 --> 01:18:07,760 MONICA TALKED ABOUT THE HOMELESS 2002 01:18:07,760 --> 01:18:08,680 GUYS HAVING SMARTPHONES, THEY 2003 01:18:08,680 --> 01:18:10,560 ARE OUT THERE, GIVES A WAY FOR 2004 01:18:10,560 --> 01:18:12,080 PEOPLE TO CONTACT PEOPLE. 2005 01:18:12,080 --> 01:18:12,520 >> OKAY. 2006 01:18:12,520 --> 01:18:14,000 IF THERE ARE NO OTHER QUESTIONS, 2007 01:18:14,000 --> 01:18:15,360 THANK YOU VERY MUCH. 2008 01:18:15,360 --> 01:18:18,200 I'LL ASK EVERYBODY TO VOTE. 2009 01:18:18,200 --> 01:18:22,800 AND THEN WE HAVE A 15-MINUTE 2010 01:18:22,800 --> 01:18:23,880 BREAK FOR EVERYBODY ONLINE AS 2011 01:18:23,880 --> 01:18:24,080 WELL. 2012 01:18:24,080 --> 01:18:29,880 AND WE'LL ASK YOU TO BE BACK AT 2013 01:18:29,880 --> 01:18:30,280 2:40. 2014 01:18:30,280 --> 01:18:31,680 PLEASE VOTE BEFORE YOU GO HAVE 2015 01:18:31,680 --> 01:18:51,000 COFFEE. 2016 01:18:51,000 --> 01:18:53,040 >>I'M KRISTEN PORTER, PROGRAM 2017 01:18:53,040 --> 01:18:53,720 OFFICER, PREVENTION SCIENCES 2018 01:18:53,720 --> 01:18:55,000 PROGRAM, SORRY I COULDN'T BE 2019 01:18:55,000 --> 01:18:58,240 THERE IN PERSON WITH YOU ALL 2020 01:18:58,240 --> 01:18:59,240 TODAY. 2021 01:18:59,240 --> 01:19:02,000 ON BEHALF OF THE GRIP TEAM I'M 2022 01:19:02,000 --> 01:19:03,640 INTRODUCING THE FUNDING CONCEPT. 2023 01:19:03,640 --> 01:19:14,320 GRIP STANDS FOR GENDER AFFIRMING 2024 01:19:14,320 --> 01:19:15,480 HORMONE THERAPY, RESILIENCE, 2025 01:19:15,480 --> 01:19:16,640 IMMUNOLOGY, PHARMACOKINETICS. 2026 01:19:16,640 --> 01:19:17,840 OBJECTIVE TO SUPPORT CRITICAL 2027 01:19:17,840 --> 01:19:19,600 RESEARCH NEEDED TO INFORM 2028 01:19:19,600 --> 01:19:21,600 STRATEGIES TO PREVENT AND TREAT 2029 01:19:21,600 --> 01:19:24,040 HIV AND OTHER SEXUALLY 2030 01:19:24,040 --> 01:19:24,720 TRANSMITTED INFECTIONS IN 2031 01:19:24,720 --> 01:19:25,360 TRANSGENDER PEOPLE. 2032 01:19:25,360 --> 01:19:27,840 THERE ARE MANY MEDICAL AND 2033 01:19:27,840 --> 01:19:29,240 SURGICAL INTERVENTIONS THAT 2034 01:19:29,240 --> 01:19:31,000 TRANSGENDER PEOPLE UNDERGO AS 2035 01:19:31,000 --> 01:19:32,840 PART OF GENDER AFFIRMATION THAT 2036 01:19:32,840 --> 01:19:36,280 MIGHT IMPACT THE ACQUISITION AND 2037 01:19:36,280 --> 01:19:43,120 TREATMENT OF HIV OR OTHER STIS. 2038 01:19:43,120 --> 01:19:49,960 DESPITE A GROWING BODY OF DATA, 2039 01:19:49,960 --> 01:19:51,560 FEW STUDIES ADDRESSED THESE 2040 01:19:51,560 --> 01:19:52,440 ISSUES IN THIS POPULATION, THIS 2041 01:19:52,440 --> 01:19:56,000 IS A NEW REQUEST FOR FUNDING 2042 01:19:56,000 --> 01:19:57,280 ANNOUNCEMENT, R01 EXCLUDING 2043 01:19:57,280 --> 01:20:01,080 CLINICAL TRIALS, FIRST YEAR 2044 01:20:01,080 --> 01:20:05,480 COSTS APPROXIMATELY $2 MILLION, 2045 01:20:05,480 --> 01:20:06,760 DURATION FIVE YEARS, WE EXPECT 2046 01:20:06,760 --> 01:20:09,120 TO FUND TWO TO THREE AWARDS, 2047 01:20:09,120 --> 01:20:13,160 NATIONAL INSTITUTES OF CHILD 2048 01:20:13,160 --> 01:20:14,360 HEALTH AND DEVELOP THE, NATIONAL 2049 01:20:14,360 --> 01:20:16,840 INSTITUTE OF MENTAL HEALTH, AND 2050 01:20:16,840 --> 01:20:20,600 NATIONAL INSTITUTE OF DRUG ABUSE 2051 01:20:20,600 --> 01:20:21,160 ARE POTENTIAL PARTNERS. 2052 01:20:21,160 --> 01:20:22,560 NEXT SLIDE PLEASE. 2053 01:20:22,560 --> 01:20:27,200 WHY SUPPORT HIV RESEARCH IN 2054 01:20:27,200 --> 01:20:27,680 TRANSGENDER INDIVIDUALS? 2055 01:20:27,680 --> 01:20:28,920 APPROXIMATELY 1.6 MILLION PEOPLE 2056 01:20:28,920 --> 01:20:33,520 IN THE UNITED STATES IDENTIFY AS 2057 01:20:33,520 --> 01:20:35,080 TRANSGENDER. 2058 01:20:35,080 --> 01:20:37,440 9.2% ARE HIV POSITIVE. 2059 01:20:37,440 --> 01:20:39,240 VERSUS .5% OF THE UNITED STATES 2060 01:20:39,240 --> 01:20:40,680 POPULATION AS A WHOLE. 2061 01:20:40,680 --> 01:20:44,240 ACCORDING TO SPECIAL REPORT BY 2062 01:20:44,240 --> 01:20:47,320 THE CDC, 42% OF TRANSGENDER 2063 01:20:47,320 --> 01:20:49,160 WOMEN ARE LIVING WITH HIV. 2064 01:20:49,160 --> 01:20:52,000 AS TRANSGENDER MEN AND WOMEN ARE 2065 01:20:52,000 --> 01:20:53,200 DISPROPORTIONATELY BURDENED BY 2066 01:20:53,200 --> 01:20:55,760 HIV, THERE'S A CLEAR NEED TO 2067 01:20:55,760 --> 01:20:56,960 UNDERSTAND IF BIOLOGICAL FACTORS 2068 01:20:56,960 --> 01:21:01,720 ARE PLAYING A ROLE. 2069 01:21:01,720 --> 01:21:02,400 NEXT SLIDE. 2070 01:21:02,400 --> 01:21:04,920 TO BEGIN TO UNDERSTAND HOW 2071 01:21:04,920 --> 01:21:15,480 GENDER AFFIRMING CARE MAY IMPACT 2072 01:21:15,920 --> 01:21:19,800 HIV, A SMALL NUMBER OF R21 IN 2073 01:21:19,800 --> 01:21:21,120 RESPONSE TO PREVENTION AND 2074 01:21:21,120 --> 01:21:24,120 TREATMENT OF HIV AND STIS. 2075 01:21:24,120 --> 01:21:26,720 NINE AWARDS MADE, SEVEN BY 2076 01:21:26,720 --> 01:21:29,560 DAIDS, 2 BY DMID. 2077 01:21:29,560 --> 01:21:32,960 THIS TABLE WE'VE LISTED R21 2078 01:21:32,960 --> 01:21:34,240 INVESTIGATORS WITH SCIENTIFIC 2079 01:21:34,240 --> 01:21:37,200 RESEARCH AREAS. 2080 01:21:37,200 --> 01:21:38,760 THESE AWARDS DEMONSTRATED 2081 01:21:38,760 --> 01:21:41,040 RECIPIENTS HAD ACCESS TO 2082 01:21:41,040 --> 01:21:41,920 TRANSGENDER POPULATIONS FOR 2083 01:21:41,920 --> 01:21:47,160 RESEARCH BUT AS THE R 21s 2084 01:21:47,160 --> 01:21:49,800 AWARDED RESULTS HAVE YET TO BE 2085 01:21:49,800 --> 01:21:51,080 PUBLISHED. 2086 01:21:51,080 --> 01:21:52,680 NEXT SLIDE PLEASE. 2087 01:21:52,680 --> 01:21:54,320 HOWEVER, WE'VE INCLUDED TWO 2088 01:21:54,320 --> 01:21:56,840 FIGURES FROM RECENT PUBLICATIONS 2089 01:21:56,840 --> 01:21:58,040 FOR RESEARCHERS CONDUCTING 2090 01:21:58,040 --> 01:21:58,800 SIMILAR STUDIES. 2091 01:21:58,800 --> 01:22:01,360 PANEL ON THE LEFT, YOU SEE 2092 01:22:01,360 --> 01:22:06,160 THERE'S A STATISTICALLY 2093 01:22:06,160 --> 01:22:07,520 SIGNIFICANT INCREASE IN THE 2094 01:22:07,520 --> 01:22:09,680 RECTAL TISSUE OF CIS AND 2095 01:22:09,680 --> 01:22:12,840 TRANSGENDER WOMEN COMPARED TO 2096 01:22:12,840 --> 01:22:13,640 MSM COUNTERPARTS. 2097 01:22:13,640 --> 01:22:18,440 RIGHT PANEL STUDY MEASURING 2098 01:22:18,440 --> 01:22:24,040 CONCENTRATIONS OF TENOFOVIR, 2099 01:22:24,040 --> 01:22:26,320 ACTIVE METABOLITE IN DRIED BLOOD 2100 01:22:26,320 --> 01:22:27,880 SPOTS, INDICATING VARIABILITY IN 2101 01:22:27,880 --> 01:22:30,280 DRUG LEVELS BETWEEN CIS AND 2102 01:22:30,280 --> 01:22:32,920 TRANSGENDER MEN AND WOMEN, 2103 01:22:32,920 --> 01:22:34,880 TRANSGENDER MEN HAVE HIGHER DRUG 2104 01:22:34,880 --> 01:22:39,360 LEVELS THAN TRANSGENDER WOMEN. 2105 01:22:39,360 --> 01:22:40,640 NEXT SLIDE PLEASE. 2106 01:22:40,640 --> 01:22:43,520 THE FOLLOW-UP IN JULY OF 2022 WE 2107 01:22:43,520 --> 01:22:45,680 HOSTED A WEBINAR WITH R21 2108 01:22:45,680 --> 01:22:47,320 RECIPIENTS TO HEAR UPDATES ON 2109 01:22:47,320 --> 01:22:51,480 RESEARCH AND GAPS THAT REMAIN 2110 01:22:51,480 --> 01:22:52,800 FOR HIV PREVENTION IN 2111 01:22:52,800 --> 01:22:57,600 TRANSGENDER PEOPLE. 2112 01:22:57,600 --> 01:22:59,040 HIGHLIGHTED IMPORTANCE OF 2113 01:22:59,040 --> 01:23:00,120 ENGAGING COMMUNITY AND PROVIDED 2114 01:23:00,120 --> 01:23:01,320 FEEDBACK FOR FUTURE INITIATIVES. 2115 01:23:01,320 --> 01:23:03,720 IN ADDITION TO THE WEBINAR WE 2116 01:23:03,720 --> 01:23:05,840 SOLICITED INPUT BROADLY FROM 2117 01:23:05,840 --> 01:23:07,360 SERVICE PROVIDERS FOR FOLLOW-UP 2118 01:23:07,360 --> 01:23:09,440 DISCUSSIONS WITH OUR TEAM. 2119 01:23:09,440 --> 01:23:11,160 TWO OF THE RESPONDENTS INCLUDED 2120 01:23:11,160 --> 01:23:13,040 WHITMAN WALKER CLINIC AND YOUTH 2121 01:23:13,040 --> 01:23:16,960 PRIDE CLINIC AT CHILDREN'S 2122 01:23:16,960 --> 01:23:22,040 NATIONAL HOSPITAL. 2123 01:23:22,040 --> 01:23:25,440 COMMON THEME, GENDER AFFIRMING 2124 01:23:25,440 --> 01:23:28,920 THERAPY IS A CONCERN, AND DRUG 2125 01:23:28,920 --> 01:23:33,640 INTERACTIONS THAT MAY IMPACT, 2126 01:23:33,640 --> 01:23:34,600 WHETHER ANTIRETROVIRALS FOR 2127 01:23:34,600 --> 01:23:36,920 PrEP OR HIV TREATMENT, 2128 01:23:36,920 --> 01:23:38,520 ACKNOWLEDGED BY ADVOCACY GROUPS 2129 01:23:38,520 --> 01:23:40,520 HIGHLIGHTING LACK OF RESEARCH 2130 01:23:40,520 --> 01:23:44,560 DATA ON DRUG-DRUG INTERACTION, 2131 01:23:44,560 --> 01:23:50,080 EFFECT ON PrEP EFFICACY, AN 2132 01:23:50,080 --> 01:23:55,640 EXAMPLE SHOWN HERE, THE AVAC 2133 01:23:55,640 --> 01:23:56,040 MANIFESTO. 2134 01:23:56,040 --> 01:23:58,040 IN THE STRATEGIC PLAN TO ADVANCE 2135 01:23:58,040 --> 01:24:00,080 RESEARCH ON HEALTH AND 2136 01:24:00,080 --> 01:24:02,400 WELL-BEING OF SEXUAL AND GENDER 2137 01:24:02,400 --> 01:24:04,800 MINORITIES, AIMS TO ADVANCE 2138 01:24:04,800 --> 01:24:07,320 RESEARCH FOR THESE POPULATIONS, 2139 01:24:07,320 --> 01:24:09,520 COLLABORATIONS BETWEEN 2140 01:24:09,520 --> 01:24:10,600 INTRAMURAL AND EXTRAMURAL 2141 01:24:10,600 --> 01:24:13,160 RESEARCHERS, FORMATION OF 2142 01:24:13,160 --> 01:24:14,760 PARTNERSHIPS WITH COMMUNITY 2143 01:24:14,760 --> 01:24:15,520 STAKEHOLDERS. 2144 01:24:15,520 --> 01:24:17,360 THE FIELD COMMUNITY ADVOCACY 2145 01:24:17,360 --> 01:24:21,400 GROUPS AND NIH HAVE DEEMED 2146 01:24:21,400 --> 01:24:22,080 TRANSGENDER BIOMEDICAL RESEARCH 2147 01:24:22,080 --> 01:24:25,400 A PRIORITY. 2148 01:24:25,400 --> 01:24:27,240 NEXT SLIDE PLEASE. 2149 01:24:27,240 --> 01:24:29,240 BASED ON FEEDBACK FROM THE 2150 01:24:29,240 --> 01:24:30,960 COMMUNITY, ADVOCACY GROUPS AND 2151 01:24:30,960 --> 01:24:32,840 LIMITED AVAILABLE INFORMATION IN 2152 01:24:32,840 --> 01:24:34,480 LITERATURE, IMPORTANT GAPS 2153 01:24:34,480 --> 01:24:36,800 REMAIN FOR HIV PREVENTION AND 2154 01:24:36,800 --> 01:24:38,720 CARE FOR TRANSGENDER PEOPLE. 2155 01:24:38,720 --> 01:24:40,720 SOME OF THESE GAPS PROGRAM 2156 01:24:40,720 --> 01:24:43,440 IDENTIFIED INCLUDE NEED FOR 2157 01:24:43,440 --> 01:24:45,400 BASIC UNDERSTANDING OF EFFECTS 2158 01:24:45,400 --> 01:24:48,480 OF GENDER AFFIRMING HORMONES ON 2159 01:24:48,480 --> 01:24:50,240 HIV SUSCEPTIBILITY AND CHANGES 2160 01:24:50,240 --> 01:24:53,080 IN MUCOSAL SCIENCE OF 2161 01:24:53,080 --> 01:24:54,720 TRANSMISSION, SAFETY, EFFICACY 2162 01:24:54,720 --> 01:24:56,680 AND PK STUDIES OF 2163 01:24:56,680 --> 01:24:59,200 ANTIRETROVIRALS IN PRESENCE OF 2164 01:24:59,200 --> 01:25:01,280 GENDER-AFFIRMING HORMONES. 2165 01:25:01,280 --> 01:25:02,160 UNDERSTANDING DRUG-DRUG 2166 01:25:02,160 --> 01:25:05,000 INTERACTIONS BETWEEN GENDER 2167 01:25:05,000 --> 01:25:05,680 AFFIRMING HORMONES AND 2168 01:25:05,680 --> 01:25:07,200 ANTIRETROVIRALS FOR TREATMENT 2169 01:25:07,200 --> 01:25:09,360 AND PREVENTION OF HIV AND 2170 01:25:09,360 --> 01:25:12,000 CO-INFECTIONS, INCLUDING LONG 2171 01:25:12,000 --> 01:25:13,320 ACTING MODALITIES. 2172 01:25:13,320 --> 01:25:16,840 RESEARCH TO UNDERSTAND IMPACT OF 2173 01:25:16,840 --> 01:25:17,440 POTENTIAL GENDER-AFFIRMING 2174 01:25:17,440 --> 01:25:21,080 HORMONE AND PrEP INTERACTION, 2175 01:25:21,080 --> 01:25:28,840 AND NEED FOR STUDY MODELS TO 2176 01:25:28,840 --> 01:25:30,160 EVALUATE GENDER-AFFIRMING 2177 01:25:30,160 --> 01:25:31,400 HORMONE AND ANTIRETROVIRALS, 2178 01:25:31,400 --> 01:25:36,360 INCLUDING ANIMAL, IN VITRO, EX 2179 01:25:36,360 --> 01:25:38,840 VIVO, IN SILICO MODELS. 2180 01:25:38,840 --> 01:25:40,160 NEXT SLIDE PLEASE. 2181 01:25:40,160 --> 01:25:42,480 TO ADDRESS THESE GAPS PROGRAM 2182 01:25:42,480 --> 01:25:44,680 HAS IDENTIFIED RESEARCH AREAS OF 2183 01:25:44,680 --> 01:25:46,520 INTEREST TO BE INCLUDED IN THE 2184 01:25:46,520 --> 01:25:47,840 GRIP RFA. 2185 01:25:47,840 --> 01:25:49,240 RESEARCH AREAS OF INTEREST 2186 01:25:49,240 --> 01:25:51,120 INCLUDE IMPACT OF GENDER 2187 01:25:51,120 --> 01:25:52,080 AFFIRMING HORMONE THERAPY IN 2188 01:25:52,080 --> 01:25:55,920 ADULTS OVER THE AGE OF 18, ON 2189 01:25:55,920 --> 01:25:58,560 PREVENTION AND TREATMENT OF HIV 2190 01:25:58,560 --> 01:26:01,840 AND/OR CO-INFECTIONS WITH OTHER 2191 01:26:01,840 --> 01:26:02,280 STIS. 2192 01:26:02,280 --> 01:26:09,640 THESE INTERESTS INCLUDE IMPACT 2193 01:26:09,640 --> 01:26:13,560 ON REGIMENS FOR PREVENTION OR 2194 01:26:13,560 --> 01:26:16,080 TREATMENT OF CO-INFECTION WITH 2195 01:26:16,080 --> 01:26:18,360 STI, STUDIES INCLUDING 2196 01:26:18,360 --> 01:26:23,520 METABOLISM AND DRUG-DRUG 2197 01:26:23,520 --> 01:26:24,840 INTERACTIONS. 2198 01:26:24,840 --> 01:26:27,000 DEVELOPMENT OF NEW ANIMAL, IN 2199 01:26:27,000 --> 01:26:29,560 VITRO, EX VIVO, AND IN SILICO 2200 01:26:29,560 --> 01:26:33,360 MODELS TO STUDY IMPACT OF GENDER 2201 01:26:33,360 --> 01:26:34,800 AFFIRMING HORMONES ON 2202 01:26:34,800 --> 01:26:36,400 IMMUNOLOGY, PHARMACOLOGY, SAFETY 2203 01:26:36,400 --> 01:26:38,520 EFFICACY OF HIV PREVENTION AND 2204 01:26:38,520 --> 01:26:41,480 TREATMENT REGIMENS AND/OR 2205 01:26:41,480 --> 01:26:44,080 CO-INFECTIONS WITH OTHER STIS. 2206 01:26:44,080 --> 01:26:46,720 IMPACT OF FEMINIZATION AND 2207 01:26:46,720 --> 01:26:49,120 MASCULINEIZATION REGIMEN ON GI 2208 01:26:49,120 --> 01:26:56,160 AND UROGENITAL MUCOSA, ROLE IN 2209 01:26:56,160 --> 01:27:01,080 HIV AND STI SUSCEPTIBILITY, 2210 01:27:01,080 --> 01:27:02,160 INFECTION, ACQUISITION. 2211 01:27:02,160 --> 01:27:02,960 HYPOTHESIS DRIVEN OMIC STUDIES 2212 01:27:02,960 --> 01:27:04,680 AND USE OF BIOLOGY TOOLS TO 2213 01:27:04,680 --> 01:27:07,760 CHARACTERIZE IMPACT OF THE 2214 01:27:07,760 --> 01:27:10,040 FEMINIZING AND MASCULINIZING 2215 01:27:10,040 --> 01:27:11,240 HORMONES ON HIV SUSCEPTIBILITY, 2216 01:27:11,240 --> 01:27:14,720 INCLUDING IN THE GI AND 2217 01:27:14,720 --> 01:27:15,960 UROGENITAL TRACTS. 2218 01:27:15,960 --> 01:27:19,440 STUDIES ON DETERMINATION OF 2219 01:27:19,440 --> 01:27:21,760 LEVELS OF GENDER AFFIRMING 2220 01:27:21,760 --> 01:27:24,040 HORMONES TO ADDRESS VARIATION 2221 01:27:24,040 --> 01:27:26,520 RELATED TO DIVERSE SOURCES OF 2222 01:27:26,520 --> 01:27:27,120 EXTERNAL HORMONES AND 2223 01:27:27,120 --> 01:27:32,360 PHYSIOLOGICAL AS WELL AS 2224 01:27:32,360 --> 01:27:34,440 PATHOPHYSIOLOGIC CONDITIONS. 2225 01:27:34,440 --> 01:27:40,440 NEXT SLIDE PLEASE. 2226 01:27:40,440 --> 01:27:42,960 PROGRAM APPRECIATES REVIEW AND 2227 01:27:42,960 --> 01:27:44,720 COMMENTS AND CONCERNS, 2228 01:27:44,720 --> 01:27:47,560 OVERARCHING COMMENTS INCLUDED 2229 01:27:47,560 --> 01:27:49,320 IT'S CRITICAL TO OBTAIN DATA TO 2230 01:27:49,320 --> 01:27:51,160 INFORM DECISION MAKING ON HIV 2231 01:27:51,160 --> 01:27:52,920 PREVENTION AND TRANSGENDER 2232 01:27:52,920 --> 01:27:54,000 PEOPLE ON GENDER AFFIRMING 2233 01:27:54,000 --> 01:27:55,080 HORMONE THERAPY. 2234 01:27:55,080 --> 01:27:56,520 IMPORTANCE OF STUDYING LONG 2235 01:27:56,520 --> 01:27:58,080 ACTING AS COMPARED TO DAILY 2236 01:27:58,080 --> 01:28:01,240 PrEP DOSING AND HOW HORMONES 2237 01:28:01,240 --> 01:28:03,040 MAY IMPACT COVERAGE OF DIFFERENT 2238 01:28:03,040 --> 01:28:03,520 PrEP REGIMENS. 2239 01:28:03,520 --> 01:28:08,680 IN THE ERA OF LONG-ACTING ART 2240 01:28:08,680 --> 01:28:10,120 AND PrEP, CISGENDER WOMEN MAY 2241 01:28:10,120 --> 01:28:11,640 DIFFER FROM MEN AND TRANSGENDER 2242 01:28:11,640 --> 01:28:15,800 WOMEN, SO IT'S IMPORTANT TO USE 2243 01:28:15,800 --> 01:28:18,000 THIS POPULATION AS CONTROLS. 2244 01:28:18,000 --> 01:28:20,520 MORE SPECIFIC CONCERNS ARE 2245 01:28:20,520 --> 01:28:24,880 INVESTIGATORS NEED TO KNOW 2246 01:28:24,880 --> 01:28:27,200 TYPES BEING TAKEN, ROUTE, 2247 01:28:27,200 --> 01:28:29,280 FORMULATION, DOSAGE, DOSING 2248 01:28:29,280 --> 01:28:30,680 SCHEDULE, MEASURING DRUG AND 2249 01:28:30,680 --> 01:28:31,800 HORMONE CONCENTRATION AS IT'S 2250 01:28:31,800 --> 01:28:33,840 IMPORTANT DUE TO VARIATION IN 2251 01:28:33,840 --> 01:28:35,600 THEIR STUDIES. 2252 01:28:35,600 --> 01:28:40,840 THE SOURCES OF HORMONES, WHETHER 2253 01:28:40,840 --> 01:28:42,840 PRESCRIBED, AS MAY SEEK HORMONES 2254 01:28:42,840 --> 01:28:45,240 OUTSIDE THE UNITED STATES, FOR 2255 01:28:45,240 --> 01:28:45,760 EXAMPLE. 2256 01:28:45,760 --> 01:28:48,200 THEY ALSO EMPHASIZE NEED FOR 2257 01:28:48,200 --> 01:28:49,400 BASIC RESEARCH INTO BIOLOGICAL 2258 01:28:49,400 --> 01:28:53,680 FACTORS THAT MAY INFLUENCE RISK, 2259 01:28:53,680 --> 01:28:57,640 SUSCEPTIBILITY, TRANSMISSION 2260 01:28:57,640 --> 01:29:00,120 AMONG TRANSGENDER PEOPLE. 2261 01:29:00,120 --> 01:29:01,240 NEXT SLIDE PLEASE. 2262 01:29:01,240 --> 01:29:03,200 TO ADDRESS CONCERNS PROGRAM WILL 2263 01:29:03,200 --> 01:29:05,280 ENCOURAGE APPLICANTS TO FOCUS ON 2264 01:29:05,280 --> 01:29:06,920 LONG ACTING PrEP MODALITIES 2265 01:29:06,920 --> 01:29:11,080 AND STUDIES THAT ASSESS EFFECTS 2266 01:29:11,080 --> 01:29:14,560 OF CHANGING PrEP OR GAHT 2267 01:29:14,560 --> 01:29:16,200 REGIMENS, CONSIDER APPROPRIATE 2268 01:29:16,200 --> 01:29:17,760 CONTROLS, INCLUDING CISGENDER 2269 01:29:17,760 --> 01:29:18,640 MEN AND WOMEN. 2270 01:29:18,640 --> 01:29:20,280 COLLECT INFORMATION ON THE TIMES 2271 01:29:20,280 --> 01:29:24,320 OF HORMONES BEING TAKEN, ROUTE, 2272 01:29:24,320 --> 01:29:25,520 FORMULATION, DOSAGE, DOSING 2273 01:29:25,520 --> 01:29:29,120 SCHEDULE, AND SOURCES OF 2274 01:29:29,120 --> 01:29:31,760 HORMONES MEASURING DRUG/HORMONE 2275 01:29:31,760 --> 01:29:32,680 CONCENTRATIONS. 2276 01:29:32,680 --> 01:29:34,160 AND INCORPORATE BASIC SCIENCE 2277 01:29:34,160 --> 01:29:41,640 RESEARCH INCLUDING OMICS STUDIES 2278 01:29:41,640 --> 01:29:44,200 TO FOCUS ON SUSCEPTIBILITY, 2279 01:29:44,200 --> 01:29:44,880 RISK, TRANSITION. 2280 01:29:44,880 --> 01:29:53,120 WITH THAT I'D BE HAPPY TO TAKE 2281 01:29:53,120 --> 01:29:53,400 QUESTIONS. 2282 01:29:53,400 --> 01:29:55,400 >> THANK YOU VERY MUCH. 2283 01:29:55,400 --> 01:30:01,800 ARE THERE ANY QUESTIONS IN THE 2284 01:30:01,800 --> 01:30:06,800 ROOM? 2285 01:30:06,800 --> 01:30:09,520 HOW ABOUT ONLINE? 2286 01:30:09,520 --> 01:30:09,680 NO? 2287 01:30:09,680 --> 01:30:10,960 NO QUESTIONS? 2288 01:30:10,960 --> 01:30:13,480 MONICA HAS A QUESTION. 2289 01:30:13,480 --> 01:30:14,040 GO AHEAD. 2290 01:30:14,040 --> 01:30:15,760 >> WE REVIEWED THIS BUT I DID 2291 01:30:15,760 --> 01:30:17,120 HAVE A QUESTION ABOUT 2292 01:30:17,120 --> 01:30:19,360 RESILIENCE, THE WORD BEING KEPT 2293 01:30:19,360 --> 01:30:21,720 IN THERE BECAUSE THAT WAS 2294 01:30:21,720 --> 01:30:22,240 CONFUSING. 2295 01:30:22,240 --> 01:30:24,120 I KNOW NIMH HAD SUPPORT BUT 2296 01:30:24,120 --> 01:30:28,240 THERE WAS NO ASPECT OF THIS THAT 2297 01:30:28,240 --> 01:30:29,000 WOULD INVOLVE QUALITATIVE 2298 01:30:29,000 --> 01:30:30,800 RESEARCH ABOUT RESILIENCE OR AT 2299 01:30:30,800 --> 01:30:32,200 LEAST AS ITS UNDERSTOOD 2300 01:30:32,200 --> 01:30:36,360 RESILIENCE, SO I WAS CURIOUS WHY 2301 01:30:36,360 --> 01:30:38,440 RESILIENCE WORD WAS KEPT IN 2302 01:30:38,440 --> 01:30:40,440 INSTEAD OF IMMUNOLOGY AND 2303 01:30:40,440 --> 01:30:41,160 PHARMACOKINETICS OUTCOMES. 2304 01:30:41,160 --> 01:30:42,280 >> EXCELLENT QUESTION. 2305 01:30:42,280 --> 01:30:46,120 YES, THAT WAS A WORD THAT WAS 2306 01:30:46,120 --> 01:30:49,400 CHOSEN BY OUR PARTNERS, BUT FOR 2307 01:30:49,400 --> 01:30:52,360 OUR PROGRAM, THAT TRANSGENDER 2308 01:30:52,360 --> 01:30:54,560 PEOPLE PRIORITIZE THEIR 2309 01:30:54,560 --> 01:30:55,720 GENDER-AFFIRMING HORMONES OVER 2310 01:30:55,720 --> 01:30:58,600 ANTIRETROVIRALS, OVER A LOT OF 2311 01:30:58,600 --> 01:31:00,400 OTHER DRUGS, DATA GENERATED FROM 2312 01:31:00,400 --> 01:31:06,280 THESE TYPES OF STUDIES ABOUT 2313 01:31:06,280 --> 01:31:12,080 GENDER-AFFIRMING HORMONES AND 2314 01:31:12,080 --> 01:31:13,960 ANTIRETROVIRAL INTERACTION MIGHT 2315 01:31:13,960 --> 01:31:15,720 ALLEVIATE CONCERNS 2316 01:31:15,720 --> 01:31:18,120 ANTIRETROVIRALS REDUCE 2317 01:31:18,120 --> 01:31:23,520 EFFECTIVENESS WHICH WOULD REDUCE 2318 01:31:23,520 --> 01:31:27,760 UPTAKE AND OVERALL 2319 01:31:27,760 --> 01:31:28,800 ANTIRETROVIRALS ACCEPTANCE. 2320 01:31:28,800 --> 01:31:29,960 >> WE BOTH AGREED THIS WAS 2321 01:31:29,960 --> 01:31:30,360 IMPORTANT. 2322 01:31:30,360 --> 01:31:32,440 ONE THING WE MENTIONED IS THAT 2323 01:31:32,440 --> 01:31:34,440 IT WOULD BE GREAT FOR NIH TO 2324 01:31:34,440 --> 01:31:40,440 SPONSOR A WORKSHOP, LONG-ACTING 2325 01:31:40,440 --> 01:31:43,640 CONTRACEPTION IN PEOPLE ON ART 2326 01:31:43,640 --> 01:31:45,480 AND WITH HIV, WE TALKED ABOUT 2327 01:31:45,480 --> 01:31:45,680 THIS. 2328 01:31:45,680 --> 01:31:47,040 THERE'S LIKE A LOT OF 2329 01:31:47,040 --> 01:31:49,280 INTERESTING RESEARCH GOING ON IN 2330 01:31:49,280 --> 01:31:53,040 THE PHARMACOKINETICS OF HOW 2331 01:31:53,040 --> 01:31:53,960 EXTERNAL HORMONES, HIV DRUGS, 2332 01:31:53,960 --> 01:31:57,200 AND, YOU KNOW, IMPACT SO I THINK 2333 01:31:57,200 --> 01:31:58,920 IT COULD BE LEARNED ACROSS 2334 01:31:58,920 --> 01:32:04,080 DIFFERENT POPULATIONS WOULD BE 2335 01:32:04,080 --> 01:32:04,360 IMPORTANT. 2336 01:32:04,360 --> 01:32:09,200 >> A WORKSHOP OR TWO IS IN THE 2337 01:32:09,200 --> 01:32:09,400 WORKS. 2338 01:32:09,400 --> 01:32:12,200 >> THANK YOU. 2339 01:32:12,200 --> 01:32:13,680 AND EVERYBODY, PLEASE VOTE. 2340 01:32:13,680 --> 01:32:17,440 AND WE'LL MOVE ON TO THE NEXT 2341 01:32:17,440 --> 01:32:21,680 PRESENTATION. 2342 01:32:21,680 --> 01:32:26,200 WHICH I BELIEVE WILL BE GIVEN BY 2343 01:32:26,200 --> 01:32:27,720 PATRICK JEAN-PHILIPPE, 2344 01:32:27,720 --> 01:32:32,400 POTENTIALLY FROM A CRUISE SHIP, 2345 01:32:32,400 --> 01:32:39,000 IF I'M NOT MISTAKEN. 2346 01:32:39,000 --> 01:32:40,160 >> NO, ACTUALLY FROM -- FIRST I 2347 01:32:40,160 --> 01:32:42,160 WANT TO MAKE SURE YOU'RE ABLE TO 2348 01:32:42,160 --> 01:32:45,800 SEE ME AND HEAR ME. 2349 01:32:45,800 --> 01:32:49,720 >> WE CAN SEE THE LOWER HALF OF 2350 01:32:49,720 --> 01:32:50,000 YOUR FACE. 2351 01:32:50,000 --> 01:32:50,280 >> OH, OKAY. 2352 01:32:50,280 --> 01:32:52,840 >> IF YOU COULD GET CLOSER TO 2353 01:32:52,840 --> 01:32:56,280 YOUR MICROPHONE IT COULD BE 2354 01:32:56,280 --> 01:32:56,480 BETTER. 2355 01:32:56,480 --> 01:32:57,680 >> ALL RIGHT. 2356 01:32:57,680 --> 01:33:03,600 SOMEHOW I'M NOT -- IS THAT 2357 01:33:03,600 --> 01:33:03,840 BETTER? 2358 01:33:03,840 --> 01:33:04,520 NO? 2359 01:33:04,520 --> 01:33:06,680 OKAY. 2360 01:33:06,680 --> 01:33:08,080 ALL RIGHT. 2361 01:33:08,080 --> 01:33:18,600 SO, WELL, THANK YOU, EVERYONE. 2362 01:33:19,640 --> 01:33:23,840 GREETINGS. 2363 01:33:23,840 --> 01:33:28,480 I WILL BE PRESENTING FOR YOUR 2364 01:33:28,480 --> 01:33:29,600 CONSIDERATION HOPEFULLY APPROVAL 2365 01:33:29,600 --> 01:33:31,440 THE INITIATIVE, LONG-ACTING DRUG 2366 01:33:31,440 --> 01:33:33,080 DELIVERY SYSTEMS FOR ART 2367 01:33:33,080 --> 01:33:35,400 OPTIMIZATION TO CHILDREN LIVING 2368 01:33:35,400 --> 01:33:41,120 WITH HIV, THE LADDS II 2369 01:33:41,120 --> 01:33:42,200 INITIATIVE. 2370 01:33:42,200 --> 01:33:42,960 NEXT SLIDE. 2371 01:33:42,960 --> 01:33:44,920 LADDS II PURPOSE TO ACCELERATE 2372 01:33:44,920 --> 01:33:46,680 DEVELOPMENT OF SAFE AND 2373 01:33:46,680 --> 01:33:49,200 EFFECTIVE LONG-ACTING DRUG 2374 01:33:49,200 --> 01:33:51,400 DELIVERY SYSTEMS FOR IMPROVED 2375 01:33:51,400 --> 01:33:55,320 SIMPLIFIED TREATMENT IN CHILDREN 2376 01:33:55,320 --> 01:33:57,720 AND THIS WILL STIMULATE 2377 01:33:57,720 --> 01:33:59,440 OPTIMIZATION AND EVALUATION OF 2378 01:33:59,440 --> 01:34:03,120 LADDS FORMULATIONS IN SUITABLE 2379 01:34:03,120 --> 01:34:05,080 PRE-CLINICAL ANIMAL MODELS, A 2380 01:34:05,080 --> 01:34:15,480 REISSUE, RENEWAL OF THE 2381 01:34:16,560 --> 01:34:18,120 MECHANISM, GRANT, R61/R33, AND 2382 01:34:18,120 --> 01:34:21,200 FIRST YEAR TOTAL COST OF $2 2383 01:34:21,200 --> 01:34:21,400 MILLION. 2384 01:34:21,400 --> 01:34:22,960 DURATION OF AWARD FIVE YEARS, 2385 01:34:22,960 --> 01:34:24,600 ANTICIPATE TO FUND THREE TO FOUR 2386 01:34:24,600 --> 01:34:27,360 AWARDS, TWO TO THREE MOVING TO 2387 01:34:27,360 --> 01:34:28,760 THE R33 PHASE. 2388 01:34:28,760 --> 01:34:31,680 AND WE ARE PARTNERING WITH NICHD 2389 01:34:31,680 --> 01:34:34,800 AND NIMH WHICH WILL BE OUR 2390 01:34:34,800 --> 01:34:41,120 PARTNERS IN THIS INITIATIVE. 2391 01:34:41,120 --> 01:34:41,680 NEXT SLIDE. 2392 01:34:41,680 --> 01:34:49,720 SO, WHY THIS IS NEEDED, SO THE 2393 01:34:49,720 --> 01:34:54,840 SLIDES DEPICTS LATEST 2022 DATA 2394 01:34:54,840 --> 01:35:01,360 ON STATE OF THE HIV EPIDEMIC IN 2395 01:35:01,360 --> 01:35:01,680 CHILDREN. 2396 01:35:01,680 --> 01:35:04,840 SUFFICE IT TO SAY STILL 2397 01:35:04,840 --> 01:35:08,360 UNACCEPTABLE IN PEDIATRIC 2398 01:35:08,360 --> 01:35:12,960 POPULATIONS, AND NUMBERS ARE 2399 01:35:12,960 --> 01:35:14,920 STAGGERING, 1.5, STILL 130,000 2400 01:35:14,920 --> 01:35:19,400 NEW INFECTIONS, 84,000 DEATHS. 2401 01:35:19,400 --> 01:35:23,360 IMPROVED BUT PACE OF IMPROVEMENT 2402 01:35:23,360 --> 01:35:25,360 IS SLOW. 2403 01:35:25,360 --> 01:35:26,000 NEXT SLIDE. 2404 01:35:26,000 --> 01:35:30,280 AND IN ADDITION TO THAT WE KNOW 2405 01:35:30,280 --> 01:35:32,360 THAT CURRENT VIRAL SUPPRESSION 2406 01:35:32,360 --> 01:35:37,920 RATES IN CHILDRENS ARE 2407 01:35:37,920 --> 01:35:40,080 SUBOPTIMAL, TREATMENT GAP, WE ON 2408 01:35:40,080 --> 01:35:42,760 THE GRAPH ON THE RIGHT UPPER 2409 01:35:42,760 --> 01:35:48,320 CORNER YOU CAN SEE THE LAST 2410 01:35:48,320 --> 01:35:53,240 GRAPHS DEPICT U.N. AIDS 2022 2411 01:35:53,240 --> 01:35:58,800 DATA IN CHILDRENS, AS PART OF 2412 01:35:58,800 --> 01:36:01,000 THE TREATMENT CASCADE TO 2413 01:36:01,000 --> 01:36:03,160 ACHIEVE, THE NUMBERS SPEAK FOR 2414 01:36:03,160 --> 01:36:07,840 THEMSELVES IN TERMS OF THE GAP 2415 01:36:07,840 --> 01:36:09,640 IN CHILDREN COMPARED TO OTHERS. 2416 01:36:09,640 --> 01:36:17,320 LOWER GRAPH WE CAN SEE THAT HOW 2417 01:36:17,320 --> 01:36:19,520 OF CHILDRENS, INFANT AND YOUNG 2418 01:36:19,520 --> 01:36:22,560 CHILDREN IN PARTICULAR, EVEN 2419 01:36:22,560 --> 01:36:23,760 LOWER, EVEN MORE EXPERIENCE 2420 01:36:23,760 --> 01:36:26,960 SUBSEQUENT VIRAL REBOUNDS. 2421 01:36:26,960 --> 01:36:29,680 YOU CAN SEE NICELY THE RATE OF 2422 01:36:29,680 --> 01:36:32,280 REBOUNDS REALLY INCREASE IN 2423 01:36:32,280 --> 01:36:34,720 CHILDRENS 0 TO 11 MONTHS, LESS 2424 01:36:34,720 --> 01:36:38,200 THAN 1 YEAR OF AGE. 2425 01:36:38,200 --> 01:36:42,040 NEXT SLIDE PLEASE. 2426 01:36:42,040 --> 01:36:46,520 AND SOME OF THE REASONS MAY HAVE 2427 01:36:46,520 --> 01:36:50,480 TO DO, KEY CONTRIBUTING FACTOR, 2428 01:36:50,480 --> 01:36:53,000 REGIMENS AVAILABLE TO CHILDREN, 2429 01:36:53,000 --> 01:36:55,080 THEY HAVE LIMITATIONS, THERE'S A 2430 01:36:55,080 --> 01:37:05,440 LOT OF -- SIGNIFICANT 2431 01:37:06,160 --> 01:37:08,120 PRE-TREATMENT DRUG RESISTANCE, 2432 01:37:08,120 --> 01:37:10,720 MANY SIDE EFFECTS, FORMULATIONS 2433 01:37:10,720 --> 01:37:16,280 IN CHILDRENS, EVEN WITH RECENT 2434 01:37:16,280 --> 01:37:23,880 STRIDES, SUBOPTIMAL, POOR 2435 01:37:23,880 --> 01:37:25,280 PALATABILITY COMPOUNDED BY 2436 01:37:25,280 --> 01:37:27,120 STIGMA AND PSYCHOSOCIAL NEEDS. 2437 01:37:27,120 --> 01:37:33,600 THERE'S ON THE HORIZON WITH 2438 01:37:33,600 --> 01:37:36,160 DOLUTEGRAVIR, IT'S AVAILABLE, 2439 01:37:36,160 --> 01:37:36,760 QUITE PROMISING, BUT LIKELIHOOD 2440 01:37:36,760 --> 01:37:39,640 IMPACT COULD STILL BE LIMITED BY 2441 01:37:39,640 --> 01:37:40,400 SOME FACTORS ABOVE. 2442 01:37:40,400 --> 01:37:42,640 WE NEED TO THINK ABOUT NOVEL 2443 01:37:42,640 --> 01:37:48,080 TREATMENT APPROACHES IN CHILDRE. 2444 01:37:48,080 --> 01:37:51,360 NEXT SLIDE. 2445 01:37:51,360 --> 01:37:56,080 AND SO LONG ACTING IS, YOU KNOW, 2446 01:37:56,080 --> 01:37:56,960 REPRESENT SIGNIFICANT 2447 01:37:56,960 --> 01:37:59,800 OPPORTUNITIES FOR PEDIATRIC HIV 2448 01:37:59,800 --> 01:38:02,320 TREATMENT, WE KNOW MAJOR ADVANCE 2449 01:38:02,320 --> 01:38:05,360 IN HIV TREATMENT, PROSPECT OF 2450 01:38:05,360 --> 01:38:08,880 ENHANCE TREATMENT, CONVENIENCE, 2451 01:38:08,880 --> 01:38:19,240 IMPROVED ADHERENCE, . 2452 01:38:22,840 --> 01:38:25,520 AND RANGING FROM EVERY TWO WEEKS 2453 01:38:25,520 --> 01:38:35,920 TO EVERY SIX MONTHS. 2454 01:38:37,520 --> 01:38:41,480 AND CAB-LA IS THE ONE APPROVED 2455 01:38:41,480 --> 01:38:45,880 FOR CHILDREN, ADOLESCENTS, AND 2456 01:38:45,880 --> 01:38:48,360 WE KNOW OPTIONS ARE BEING 2457 01:38:48,360 --> 01:38:51,800 DEVELOPED BUT AS USUAL IN 2458 01:38:51,800 --> 01:38:54,280 TRADITIONAL IT'S THE PEDIATRIC 2459 01:38:54,280 --> 01:38:55,840 DEVELOPMENT CONTINUES TO 2460 01:38:55,840 --> 01:38:57,160 SIGNIFICANTLY BE BEHIND 2461 01:38:57,160 --> 01:38:59,240 DEVELOPMENT, FURTHER WE KNOW 2462 01:38:59,240 --> 01:39:04,480 BENEFITS WILL BE SLOW TO EXTEND 2463 01:39:04,480 --> 01:39:05,240 TO YOUNGER PEDIATRIC POPULATIONS 2464 01:39:05,240 --> 01:39:07,320 WHICH WOULD BE THE LAST ONE TO 2465 01:39:07,320 --> 01:39:08,560 BENEFIT FROM THIS TREATMENT 2466 01:39:08,560 --> 01:39:13,360 INNOVATION SO WE REALLY NEED 2467 01:39:13,360 --> 01:39:14,080 INNOVATIVE TRANSMISSION 2468 01:39:14,080 --> 01:39:18,480 APPROACHES TO ACCELERATE CURRENT 2469 01:39:18,480 --> 01:39:21,000 AND FUTURE PEDIATRIC 2470 01:39:21,000 --> 01:39:24,960 POPULATIONS. 2471 01:39:24,960 --> 01:39:31,920 NEXT SLIDE PLEASE. 2472 01:39:31,920 --> 01:39:34,600 AND THE SCOPE AND AREA I'M GOING 2473 01:39:34,600 --> 01:39:37,000 TO GO OVER THOSE. 2474 01:39:37,000 --> 01:39:40,120 WE ANTICIPATE SUCCESSFUL 2475 01:39:40,120 --> 01:39:44,520 APPLICATION WE NEED TO PROPOSE 2476 01:39:44,520 --> 01:39:46,520 DELIVERY SYSTEM, KEY 2477 01:39:46,520 --> 01:39:48,920 CHARACTERISTICS, SHOULD BE 2478 01:39:48,920 --> 01:39:50,160 DEVELOPED FOR TARGETING 2479 01:39:50,160 --> 01:39:54,280 POPULATIONS LESS THAN 12 YEARS 2480 01:39:54,280 --> 01:39:56,920 OLD, SHOULD TAKE ADVANTAGE OF 2481 01:39:56,920 --> 01:39:58,560 ARRAY, EXPANDING ARRAY OF 2482 01:39:58,560 --> 01:40:00,960 TECHNOLOGY AVAILABLE, REGARDLESS 2483 01:40:00,960 --> 01:40:07,520 OF WHAT IT CHOOSES TECHNOLOGY 2484 01:40:07,520 --> 01:40:08,080 SHOULD ACCOMMODATE PEDIATRIC 2485 01:40:08,080 --> 01:40:09,840 POPULATIONS, DEVELOPED FOR HIV 2486 01:40:09,840 --> 01:40:11,920 AND OTHER APPLICATIONS, AND THIS 2487 01:40:11,920 --> 01:40:14,760 TIME WILL REQUIRE MINIMUM DOSING 2488 01:40:14,760 --> 01:40:18,320 INTERVAL OF 8 WEEKS, AND FURTHER 2489 01:40:18,320 --> 01:40:25,200 SHOULD DELIVER COMPLETE AND 2490 01:40:25,200 --> 01:40:27,040 CLINICALLY RELEVANT REGIMEN WITH 2491 01:40:27,040 --> 01:40:29,440 SINGLE PLATFORM, EXPOSURE 2492 01:40:29,440 --> 01:40:31,760 MATCHING WITH ADULT EXPOSURE 2493 01:40:31,760 --> 01:40:34,840 WITH EFFICACY FOR EACH ARV 2494 01:40:34,840 --> 01:40:35,080 TREATMENT. 2495 01:40:35,080 --> 01:40:41,360 WE'LL ALLOW SINGLE ARV WITHIN A 2496 01:40:41,360 --> 01:40:44,120 PLATFORM BUT DO WANT COMPLETE 2497 01:40:44,120 --> 01:40:48,840 PLATFORM DELIVERED REGIMEN 2498 01:40:48,840 --> 01:40:51,040 PROPOSED, SHOULD MAKE EFFICIENT 2499 01:40:51,040 --> 01:40:55,640 USE OF ANIMAL MODELS AND SHOULD 2500 01:40:55,640 --> 01:41:00,760 SUPPORT PK/PD STUDIES, AND WE'RE 2501 01:41:00,760 --> 01:41:02,280 REQUIRED ANTI-VIRAL STUDY OF 2502 01:41:02,280 --> 01:41:08,520 SAFETY AND EFFICACY OF THE LADDS 2503 01:41:08,520 --> 01:41:09,520 CANDIDATE IN NHP. 2504 01:41:09,520 --> 01:41:12,440 NEXT SLIDE PLEASE. 2505 01:41:12,440 --> 01:41:14,680 AND ADDITIONAL KEY REQUIREMENTS 2506 01:41:14,680 --> 01:41:19,360 WOULD BE ITERATIVE 2507 01:41:19,360 --> 01:41:23,480 SOCIOBEHAVIORAL STUDIES, PERFORM 2508 01:41:23,480 --> 01:41:24,920 WORK, PERFORMED 2509 01:41:24,920 --> 01:41:26,360 [AUDIO DISTORTION] 2510 01:41:26,360 --> 01:41:29,200 AND THOSE GROUPS WHO WILL BE 2511 01:41:29,200 --> 01:41:31,080 USED FOR PURPOSE OF ASSESSING 2512 01:41:31,080 --> 01:41:33,800 END USER PREFERENCE AND PANEL OF 2513 01:41:33,800 --> 01:41:35,360 DESIGN, WILL REQUIRE INDUSTRY 2514 01:41:35,360 --> 01:41:39,200 AND DRUG DEVELOPMENT PARTNER 2515 01:41:39,200 --> 01:41:40,520 WITH SIGNIFICANT (INDISCERNIBLE) 2516 01:41:40,520 --> 01:41:46,960 AND APPLICANT WILL NEED TO PLAN 2517 01:41:46,960 --> 01:41:48,800 AND CONDUCT WITH PRE-IND. 2518 01:41:48,800 --> 01:41:51,000 WE HAVE LISTED NONRESPONSIVE 2519 01:41:51,000 --> 01:41:54,600 AREAS OF RESEARCH BELOW. 2520 01:41:54,600 --> 01:41:59,520 SUFFICE IT TO SAY THAT A KEY 2521 01:41:59,520 --> 01:42:05,200 AREA WE WOULD NOT -- THERE WOULD 2522 01:42:05,200 --> 01:42:11,880 BE THE ENGINEERING, WOULD NOT BE 2523 01:42:11,880 --> 01:42:14,400 [AUDIO DISTORTION] 2524 01:42:14,400 --> 01:42:17,160 , NEW MOLECULAR ENTITY, ALONG 2525 01:42:17,160 --> 01:42:18,120 WITH CLINICAL TRIALS. 2526 01:42:18,120 --> 01:42:21,280 THE OTHERS ARE LISTED HERE AS 2527 01:42:21,280 --> 01:42:28,520 WELL. 2528 01:42:28,520 --> 01:42:31,720 NEXT SLIDE PLEASE. 2529 01:42:31,720 --> 01:42:37,080 THIS WILL USE PHASED INNOVATION 2530 01:42:37,080 --> 01:42:38,720 AWARDS, R61/R33 MECHANISMS, USED 2531 01:42:38,720 --> 01:42:40,360 TO SUPPORT HIGH RISK RESEARCH 2532 01:42:40,360 --> 01:42:42,440 AND DEVELOPMENT OF PROMISING AND 2533 01:42:42,440 --> 01:42:46,480 VIABLE CANDIDATE PRODUCTS OR 2534 01:42:46,480 --> 01:42:47,440 STRATEGIES. 2535 01:42:47,440 --> 01:42:48,440 PHASED GRANT AWARD MECHANISMS 2536 01:42:48,440 --> 01:42:51,440 USED FOR EARLY STAGE RESEARCH 2537 01:42:51,440 --> 01:42:52,720 AND DISCOVERY, PRE-CLINICAL 2538 01:42:52,720 --> 01:42:58,880 DEVELOPMENT OF CANDIDATE 2539 01:42:58,880 --> 01:43:00,840 PRODUCTS AND EXPLORATORY 2540 01:43:00,840 --> 01:43:01,320 PROJECTS. 2541 01:43:01,320 --> 01:43:05,760 AND THESE ARE SINGLE 2542 01:43:05,760 --> 01:43:08,360 APPLICATIONS, DISCOVERY PHASE 2543 01:43:08,360 --> 01:43:11,680 R61 AND IMPLEMENTATION PHASE R33 2544 01:43:11,680 --> 01:43:12,240 PHASES. 2545 01:43:12,240 --> 01:43:18,600 TRANSITION TO R33 PHASE 2546 01:43:18,600 --> 01:43:19,680 CONTINGENT ON SATISFACTORY R61 2547 01:43:19,680 --> 01:43:23,160 PILE STONE AND SUBJECT TO 2548 01:43:23,160 --> 01:43:28,080 FUNDING AVAILABILITY. 2549 01:43:28,080 --> 01:43:32,480 AND THIS AWARD WILL USE PHASED 2550 01:43:32,480 --> 01:43:34,680 RESEARCH ACTIVITIES, BOTH PHASES 2551 01:43:34,680 --> 01:43:38,720 WILL NEED TO PROPOSE MILESTONES 2552 01:43:38,720 --> 01:43:41,960 PROGRAM APPROVED, AND R61 PHASE 2553 01:43:41,960 --> 01:43:48,440 WILL FUND ACTIVITIES TO OPTIMIZE 2554 01:43:48,440 --> 01:43:50,000 LONG ACTING, TWO YEARS, 2555 01:43:50,000 --> 01:43:53,600 MILESTONES WOULD NEED TO BE 2556 01:43:53,600 --> 01:43:54,680 FORMULATED ACCORDINGLY, WHILE 2557 01:43:54,680 --> 01:43:56,880 THE R33 PHASE WILL FUND 2558 01:43:56,880 --> 01:44:01,480 PRE-CLINICAL ACTIVITIES SUCH AS 2559 01:44:01,480 --> 01:44:04,440 EXPANDED STUDIES, NHP ANTI-VIRAL 2560 01:44:04,440 --> 01:44:05,880 SAFETY AND EFFICACY, OPTIMIZED 2561 01:44:05,880 --> 01:44:09,120 LADDS FORMULATIONS AS WELL AS 2562 01:44:09,120 --> 01:44:10,760 PUTTING TOGETHER PRE-IND PACKAGE 2563 01:44:10,760 --> 01:44:13,720 AND CONDUCTING THAT PRE-IND 2564 01:44:13,720 --> 01:44:16,560 MEETING. 2565 01:44:16,560 --> 01:44:17,440 NEXT SLIDE PLEASE. 2566 01:44:17,440 --> 01:44:22,240 WHY IS THE ISSUE NEEDED? 2567 01:44:22,240 --> 01:44:25,760 WELL, LADDS II IS BUILDING ON 2568 01:44:25,760 --> 01:44:32,320 CONTINUING RESEARCH FROM LADDS 2569 01:44:32,320 --> 01:44:35,400 I, SEPARATE PROJECTS, ALL THREE 2570 01:44:35,400 --> 01:44:37,040 SUCCESSFULLY TRANSITIONED TO R33 2571 01:44:37,040 --> 01:44:40,080 PHASE, PRESENTED DIFFERENT LONG 2572 01:44:40,080 --> 01:44:47,360 ACTING PLATFORMS SUCH AS 2573 01:44:47,360 --> 01:44:51,400 MICROARRAY PATCH, AND THOSE 2574 01:44:51,400 --> 01:44:53,760 APPLICANTS TO MOVE TO MILESTONES 2575 01:44:53,760 --> 01:44:55,840 AND CONTINUING THAT RESEARCH, SO 2576 01:44:55,840 --> 01:44:59,880 WE THINK IT WAS A SUCCESSFUL 2577 01:44:59,880 --> 01:45:03,000 LADDS I, POISED TO BE A 2578 01:45:03,000 --> 01:45:03,720 SUCCESSFUL PROJECT. 2579 01:45:03,720 --> 01:45:07,560 LADDS II EXPANDS UPON THIS LADDS 2580 01:45:07,560 --> 01:45:08,440 I, ADDS REQUIREMENTS BELOW, 2581 01:45:08,440 --> 01:45:11,280 WHICH I ALREADY MENTIONED SUCH 2582 01:45:11,280 --> 01:45:15,960 AS MINIMUM DOSING INTERVAL TO 2583 01:45:15,960 --> 01:45:17,960 EXTEND TO 8 WEEKS, THE SCOPE OF 2584 01:45:17,960 --> 01:45:19,920 THE SOCIAL BEHAVIORAL SCIENCE 2585 01:45:19,920 --> 01:45:22,960 AND END USER ASSESSMENT RESEARCH 2586 01:45:22,960 --> 01:45:28,680 HAS BEEN SIGNIFICANTLY EXPENDED, 2587 01:45:28,680 --> 01:45:30,000 AND INTRODUCES NEW PRE-IND 2588 01:45:30,000 --> 01:45:31,400 MEETING WITH FDA REQUIREMENT 2589 01:45:31,400 --> 01:45:37,840 WHICH I JUST MENTIONED. 2590 01:45:37,840 --> 01:45:39,200 NEXT SLIDE PLEASE. 2591 01:45:39,200 --> 01:45:45,520 AND THERE ARE OTHER PROGRAMS, 2592 01:45:45,520 --> 01:45:50,840 SOME INCLUDE ACTIVITIES IN 2593 01:45:50,840 --> 01:45:55,160 PEDIATRIC POPULATIONS, BUT LADDS 2594 01:45:55,160 --> 01:46:00,360 II IS DIFFERENT, PARTICULARLY 2595 01:46:00,360 --> 01:46:06,880 THE RAPPS, NOSI, NONE OF THEM 2596 01:46:06,880 --> 01:46:09,520 SUPPORT THIS COORDINATED 2597 01:46:09,520 --> 01:46:13,760 LONGITUDINAL PROGRAM TO MOVE, 2598 01:46:13,760 --> 01:46:19,480 YOU KNOW, TO MOVE AT STAGE OF 2599 01:46:19,480 --> 01:46:21,200 DISEASE DEVELOPMENT TO 2600 01:46:21,200 --> 01:46:22,520 POTENTIALLY TRANSMISSION OF 2601 01:46:22,520 --> 01:46:26,040 SUPPORTING TRANSMISSION OF 2602 01:46:26,040 --> 01:46:27,680 RESEARCH AND ACTIVITIES MOVING 2603 01:46:27,680 --> 01:46:29,000 EARLIER TO CLINICAL TESTING IN 2604 01:46:29,000 --> 01:46:29,400 CHILDREN. 2605 01:46:29,400 --> 01:46:32,160 NEXT SLIDE PLEASE. 2606 01:46:32,160 --> 01:46:35,880 2607 01:46:35,880 --> 01:46:43,120 AND SO THIS WAS REVIEWED BY DR. 2608 01:46:43,120 --> 01:46:45,920 ABRAMS AND DR. GANDHI. 2609 01:46:45,920 --> 01:46:51,000 WE'RE GRATEFUL FOR INSIGHTFUL 2610 01:46:51,000 --> 01:46:53,720 COMMENTS, PARTICULARLY DR. 2611 01:46:53,720 --> 01:46:55,040 ABRAMS AND GHANDI FELT IT WAS 2612 01:46:55,040 --> 01:46:57,960 BORE ACTIVE TO GET LONG ACTING 2613 01:46:57,960 --> 01:46:59,280 FORMULATIONS TO CHILDREN. 2614 01:46:59,280 --> 01:47:05,960 AND AND HERE ARE SOME COMMENTS. 2615 01:47:05,960 --> 01:47:11,200 THEY ASKED ABOUT USE OF R61 R33 2616 01:47:11,200 --> 01:47:12,960 MECHANISMS, WHY IT'S NEEDED, AND 2617 01:47:12,960 --> 01:47:16,240 BETTER THAN OTHER MECHANISMS. 2618 01:47:16,240 --> 01:47:19,080 AGAIN I MENTIONED EARLIER THIS 2619 01:47:19,080 --> 01:47:25,520 IS MILESTONE-DRIVEN MECHANISM, 2620 01:47:25,520 --> 01:47:28,160 BIPHASIC NATURE IS CONTINGENT ON 2621 01:47:28,160 --> 01:47:28,600 MILESTONES. 2622 01:47:28,600 --> 01:47:39,160 WE SHOULD SAY ALSO CONTINGENT ON 2623 01:47:41,480 --> 01:47:42,000 DEMONSTRATING (INDISCERNIBLE) 2624 01:47:42,000 --> 01:47:44,880 MILESTONES, THE HIGH RISK NATURE 2625 01:47:44,880 --> 01:47:46,760 OF THE SOLICITED PROJECTS, 2626 01:47:46,760 --> 01:47:53,320 FURTHER CLARIFY IN THE 2627 01:47:53,320 --> 01:47:54,400 PRESENTATION, AND FULLY DESCRIBE 2628 01:47:54,400 --> 01:47:55,440 IN THE NOFO. 2629 01:47:55,440 --> 01:47:59,440 IF HE ASKED TO CLARIFY MAIN 2630 01:47:59,440 --> 01:48:01,560 FOCUS, IT IS ON DELIVERY SYSTEM, 2631 01:48:01,560 --> 01:48:03,440 WHICH HOPEFULLY WE DID, SO THE 2632 01:48:03,440 --> 01:48:04,600 FOCUS IS REALLY ON DEVELOPMENT 2633 01:48:04,600 --> 01:48:13,160 OF THE SYSTEM. 2634 01:48:13,160 --> 01:48:15,920 AND WE EXPECT PAYLOAD WILL BE 2635 01:48:15,920 --> 01:48:18,000 CLINICAL RELEVANT, AND WE 2636 01:48:18,000 --> 01:48:27,760 FURTHER CLARIFY IN THE NOFO. 2637 01:48:27,760 --> 01:48:30,800 CLARIFY MODE OF ADMINISTRATION, 2638 01:48:30,800 --> 01:48:33,120 WHETHER PATCH, IMPLANT, INEXTRA 2639 01:48:33,120 --> 01:48:33,480 MUSCULAR. 2640 01:48:33,480 --> 01:48:34,440 AND MINIMIZE PAIN. 2641 01:48:34,440 --> 01:48:36,520 WE DO NOT PARTICULAR TATE A 2642 01:48:36,520 --> 01:48:39,400 SPECIFIC PLATFORM BUT DO REQUIRE 2643 01:48:39,400 --> 01:48:41,120 CHOSEN PLATFORM BE APPROPRIATE 2644 01:48:41,120 --> 01:48:43,080 TO TARGET POPULATIONS SELECTED. 2645 01:48:43,080 --> 01:48:46,160 AND FURTHER THE EXPANDED 2646 01:48:46,160 --> 01:48:47,360 REQUIREMENTS FOR SOCIOBEHAVIORAL 2647 01:48:47,360 --> 01:48:49,400 STUDIES AS WE MENTIONED, AND THE 2648 01:48:49,400 --> 01:48:53,440 FACT THAT IT MUST INFORM THE END 2649 01:48:53,440 --> 01:49:00,040 USER OF FINAL -- END USER -- THE 2650 01:49:00,040 --> 01:49:06,480 FINAL PRODUCT, AND WE HOPE THIS 2651 01:49:06,480 --> 01:49:11,080 WILL ENSURE WHAT WE THINK IS A 2652 01:49:11,080 --> 01:49:15,000 PROJECT FOR FINAL SYSTEM FOR 2653 01:49:15,000 --> 01:49:18,160 CHILDRENS. 2654 01:49:18,160 --> 01:49:20,160 NEXT SLIDE PLEASE. 2655 01:49:20,160 --> 01:49:22,200 AND REVIEWERS ASKED US TO 2656 01:49:22,200 --> 01:49:29,560 CLARIFY WHO IS TARGETED, IS IT 2657 01:49:29,560 --> 01:49:32,280 ACADEMIA, VERSUS INDUSTRY. 2658 01:49:32,280 --> 01:49:34,480 WHAT WE THINK, SO WE CLARIFY 2659 01:49:34,480 --> 01:49:37,240 THIS IS EXPECTED TO SUPPORT 2660 01:49:37,240 --> 01:49:38,880 MULTI-DISCIPLINARY GROUPS, THEY 2661 01:49:38,880 --> 01:49:40,760 COULD BE ACADEMIA OR INDUSTRY 2662 01:49:40,760 --> 01:49:43,720 LED, BUT THEY SHOULD HAVE 2663 01:49:43,720 --> 01:49:44,680 COMPLEMENTARY EXPERTISE TO 2664 01:49:44,680 --> 01:49:46,880 SUCCESSFULLY IMPLEMENT THESE 2665 01:49:46,880 --> 01:49:47,480 PROJECTS. 2666 01:49:47,480 --> 01:49:51,120 AND IN PARTICULAR WE WANT TO 2667 01:49:51,120 --> 01:49:57,400 ENSURE THERE IS SUBSTANTIAL 2668 01:49:57,400 --> 01:49:59,000 INDUSTRY PARTNERSHIP AND 2669 01:49:59,000 --> 01:50:03,960 INDUSTRY DRUG DEVELOPER AND HOPE 2670 01:50:03,960 --> 01:50:06,160 WILL BRING CONTRIBUTION TO 2671 01:50:06,160 --> 01:50:11,520 ENSURE THERE IS POTENTIAL 2672 01:50:11,520 --> 01:50:11,960 MARKET. 2673 01:50:11,960 --> 01:50:13,280 AND FINALLY SUGGESTED 2674 01:50:13,280 --> 01:50:14,000 COMMUNICATION SHOULD BE 2675 01:50:14,000 --> 01:50:17,320 ENCOURAGED WITHIN ENTITIES IN 2676 01:50:17,320 --> 01:50:18,880 THE NOFO AND PLANS SHOULD BE 2677 01:50:18,880 --> 01:50:21,480 INCLUDED FOR FUTURE LINKING TO 2678 01:50:21,480 --> 01:50:24,360 OTHER DAIDS-FUNDED PEDIATRIC 2679 01:50:24,360 --> 01:50:30,600 EFFORTS SUCH AS IMPAACT, AND WE 2680 01:50:30,600 --> 01:50:37,520 AGREE, SHOULD BE SHARED IN THIS 2681 01:50:37,520 --> 01:50:43,200 INITIATIVE WITH GROUPS SUCH AS 2682 01:50:43,200 --> 01:50:45,920 IMPAACT AND THINK THAT WOULD BE 2683 01:50:45,920 --> 01:50:48,560 IMPORTANT TO INCLUDE CLINICAL 2684 01:50:48,560 --> 01:50:49,320 TRANSLATION POTENTIAL TO 2685 01:50:49,320 --> 01:50:51,520 CHILDREN AND THAT WOULD BE A 2686 01:50:51,520 --> 01:50:52,720 PROGRAM PRIORITY. 2687 01:50:52,720 --> 01:50:57,000 NEXT SLIDE PLEASE. 2688 01:50:57,000 --> 01:51:00,360 2689 01:51:00,360 --> 01:51:02,200 AND SO INITIATIVE SUMMARY SLIDE. 2690 01:51:02,200 --> 01:51:03,880 THAT'S THE END OF MY 2691 01:51:03,880 --> 01:51:04,200 PRESENTATIONS. 2692 01:51:04,200 --> 01:51:05,640 AND I CAN TAKE ANY QUESTIONS, 2693 01:51:05,640 --> 01:51:08,280 AND THANK YOU. 2694 01:51:08,280 --> 01:51:14,280 2695 01:51:14,280 --> 01:51:17,680 2696 01:51:17,680 --> 01:51:19,640 [AUDIO DISTORTION] 2697 01:51:19,640 --> 01:51:22,080 >> THERE WE GO. 2698 01:51:22,080 --> 01:51:23,160 REALLY INTERESTING PROPOSAL, 2699 01:51:23,160 --> 01:51:24,760 REALLY GREAT TO SEE THIS. 2700 01:51:24,760 --> 01:51:30,840 IT STRIKES ME THIS IS A CONCEPT 2701 01:51:30,840 --> 01:51:31,960 IN WHICH COMMUNITY FEEDBACK, THE 2702 01:51:31,960 --> 01:51:33,680 PEOPLE WHO ARE GOING TO BE 2703 01:51:33,680 --> 01:51:36,000 GETTING THIS, THEIR FEEDBACK IS 2704 01:51:36,000 --> 01:51:38,480 REALLY IMPORTANT, SO I REALLY 2705 01:51:38,480 --> 01:51:41,320 APPRECIATE THE BEHAVIORAL 2706 01:51:41,320 --> 01:51:42,320 SCIENCE USER ACCEPTABILITIES, 2707 01:51:42,320 --> 01:51:44,480 BUT I'M WORRIED THAT MAY COME IN 2708 01:51:44,480 --> 01:51:47,000 LATE IN THE PROCESS WHEN CERTAIN 2709 01:51:47,000 --> 01:51:48,120 REALLY IMPORTANT DECISIONS HAVE 2710 01:51:48,120 --> 01:51:49,880 BEEN MADE. 2711 01:51:49,880 --> 01:51:51,640 SO CAN YOU MAYBE JUST FILL US IN 2712 01:51:51,640 --> 01:51:53,040 ON WHAT YOU'RE DOING TO 2713 01:51:53,040 --> 01:51:56,000 ENCOURAGE THAT TO HAPPEN UP 2714 01:51:56,000 --> 01:51:57,640 FRONT SO POTENTIALLY MODIFIABLE 2715 01:51:57,640 --> 01:52:00,960 THINGS ARE ACTUALLY DONE BEFORE 2716 01:52:00,960 --> 01:52:02,560 THEY ARE LOCKED DOWN AND THE 2717 01:52:02,560 --> 01:52:04,120 STUDY GETS TOO FAR TO CHANGE 2718 01:52:04,120 --> 01:52:04,360 ANYTHING. 2719 01:52:04,360 --> 01:52:08,280 >> IT IS A GREAT POINT. 2720 01:52:08,280 --> 01:52:10,880 THEY SHOULD BE INITIATED EARLY 2721 01:52:10,880 --> 01:52:13,200 IN THE R61 PHASE. 2722 01:52:13,200 --> 01:52:15,720 SO VERY EARLY. 2723 01:52:15,720 --> 01:52:22,080 THERE WILL BE PART OF THE 2724 01:52:22,080 --> 01:52:25,680 MILESTONES TO INCLUDE USER 2725 01:52:25,680 --> 01:52:26,560 INFORMED ACTIVITIES, INFORMING 2726 01:52:26,560 --> 01:52:29,160 PANEL DESIGN. 2727 01:52:29,160 --> 01:52:34,360 WE MAY NOT BE VERY DIRECTED IN 2728 01:52:34,360 --> 01:52:36,160 TELLING EXACTLY WHAT THEY NEED 2729 01:52:36,160 --> 01:52:39,800 TO DO BUT WANT TO ESTABLISH WHAT 2730 01:52:39,800 --> 01:52:45,600 ARE THE ESSENTIAL PREMISES. 2731 01:52:45,600 --> 01:52:50,080 AND WE CERTAINLY -- WE HOPE THAT 2732 01:52:50,080 --> 01:52:53,360 WE HAVE USED CLEAR LANGUAGE IN 2733 01:52:53,360 --> 01:52:58,200 THE NOFO THAT REALLY HIGHLIGHTS 2734 01:52:58,200 --> 01:53:00,360 AND EXPANDS ON HOW THOSE 2735 01:53:00,360 --> 01:53:05,520 ACTIVITIES NEEDS TO BE NOT ONLY 2736 01:53:05,520 --> 01:53:08,480 START EARLY, BE ITERATIVE 2737 01:53:08,480 --> 01:53:09,640 THROUGHOUT THE PRODUCT 2738 01:53:09,640 --> 01:53:13,480 DEVELOPMENT, ON EACH PHASE, AND 2739 01:53:13,480 --> 01:53:15,480 WITH THE KEY PURPOSE OF EARNING 2740 01:53:15,480 --> 01:53:19,840 AS THEY ACCOMPLISH, THEY CAN GET 2741 01:53:19,840 --> 01:53:24,440 FEEDBACK TO THE DEVELOPMENT 2742 01:53:24,440 --> 01:53:27,200 WHICH CAN IN TERN BE SORT OF 2743 01:53:27,200 --> 01:53:30,120 MODIFIED AND ADJUSTED TO ENSURE 2744 01:53:30,120 --> 01:53:34,200 THAT IT MEETS THE END USER 2745 01:53:34,200 --> 01:53:39,680 CHARACTERISTICS WHICH HAVE BEEN 2746 01:53:39,680 --> 01:53:39,920 COLLECTED. 2747 01:53:39,920 --> 01:53:43,480 AND SO WHILE WE MAY NOT BE VERY 2748 01:53:43,480 --> 01:53:45,000 DIRECTLY HOW THIS IS GOING TO 2749 01:53:45,000 --> 01:53:46,400 DONE WE HOPE WE SENT A CLEAR 2750 01:53:46,400 --> 01:53:49,200 MESSAGE IN TERMS OF WHAT OUR 2751 01:53:49,200 --> 01:53:50,480 EXPECTATION IS, AND THAT 2752 01:53:50,480 --> 01:53:52,560 HOPEFULLY THAT'S WHAT WILL BE 2753 01:53:52,560 --> 01:53:53,000 DELIVERED TO US. 2754 01:53:53,000 --> 01:53:55,280 >> JUST AS A FOLLOW-UP, I MIGHT 2755 01:53:55,280 --> 01:53:56,600 ENCOURAGE YOU TO JUST CONSIDER 2756 01:53:56,600 --> 01:53:59,080 BEING A LITTLE BIT PRESCRIPTIVE 2757 01:53:59,080 --> 01:54:00,520 IN THIS CASE, AT LEAST GETTING 2758 01:54:00,520 --> 01:54:01,960 FEEDBACK FROM COMMUNITY FOLKS 2759 01:54:01,960 --> 01:54:02,680 HERE. 2760 01:54:02,680 --> 01:54:04,600 I REALLY THINK THAT STUFF DOES 2761 01:54:04,600 --> 01:54:06,120 NEED TO HAPPEN IN THE R61 PHASE 2762 01:54:06,120 --> 01:54:07,520 AND HOPEFULLY THAT'S NOT 2763 01:54:07,520 --> 01:54:08,960 OPTIONAL BECAUSE I THINK IT'S 2764 01:54:08,960 --> 01:54:14,360 PRETTY LATE IN THE R33 PHASE. 2765 01:54:14,360 --> 01:54:15,880 >> THAT SOUNDS GOOD. 2766 01:54:15,880 --> 01:54:17,840 SO WE WILL GO BACK AND LOOK AT 2767 01:54:17,840 --> 01:54:20,040 THIS AND SEE IF WE CAN IMPROVE 2768 01:54:20,040 --> 01:54:23,200 WITH THAT IN MIND. 2769 01:54:23,200 --> 01:54:27,480 2770 01:54:27,480 --> 01:54:31,080 >> ARE THERE QUESTIONS? 2771 01:54:31,080 --> 01:54:32,080 NOTHING ONLINE? 2772 01:54:32,080 --> 01:54:35,040 THANKS SO MUCH, PATRICK. 2773 01:54:35,040 --> 01:54:37,280 WE'LL MOVE ON NOW, TWO 2774 01:54:37,280 --> 01:54:42,480 PRESENTATIONS FROM THE VACCINE 2775 01:54:42,480 --> 01:54:44,560 RESEARCH GROUP, STARTING WITH 2776 01:54:44,560 --> 01:54:52,200 AMY PALIN WHO IS LIVE HERE. 2777 01:54:52,200 --> 01:54:58,240 2778 01:54:58,240 --> 01:55:01,840 2779 01:55:01,840 --> 01:55:03,840 >> LOVELY TO SPEAK TO A ROOMFUL 2780 01:55:03,840 --> 01:55:07,000 OF PEOPLE AND NOT MY COMPUTER 2781 01:55:07,000 --> 01:55:07,240 SCREEN. 2782 01:55:07,240 --> 01:55:09,200 I'M AMY PALIN, PROGRAM OFFICER 2783 01:55:09,200 --> 01:55:10,840 IN THE VACCINE PROGRAM. 2784 01:55:10,840 --> 01:55:14,040 AND TODAY I'M PRESENTING AN 2785 01:55:14,040 --> 01:55:17,320 INITIATIVE, ENGINEERING DURABLE 2786 01:55:17,320 --> 01:55:18,840 HIV VACCINE RESPONSES, ENDURE. 2787 01:55:18,840 --> 01:55:21,600 THE OBJECTIVE IS TO DEVELOP HIV 2788 01:55:21,600 --> 01:55:23,120 VACCINE TECHNOLOGY WITH 2789 01:55:23,120 --> 01:55:25,640 POTENTIAL TO CONFER DURABLE 2790 01:55:25,640 --> 01:55:27,160 IMMUNE RESPONSES THROUGH 2791 01:55:27,160 --> 01:55:27,720 HYPOTHESIS-GUIDED BASIC AND 2792 01:55:27,720 --> 01:55:28,240 APPLIED RESEARCH. 2793 01:55:28,240 --> 01:55:31,200 THIS IS A NEW INITIATIVE, R01, 2794 01:55:31,200 --> 01:55:36,560 FIRST YEAR TOTAL COST OF $3 2795 01:55:36,560 --> 01:55:37,040 MILLION. 2796 01:55:37,040 --> 01:55:39,840 IN JULY 2022 WE ORGANIZED A 2797 01:55:39,840 --> 01:55:42,360 WORKSHOP ON VACCINE DURABILITY. 2798 01:55:42,360 --> 01:55:45,320 AND HERE I'M HIGHLIGHTING 2799 01:55:45,320 --> 01:55:50,680 FACTORS ASSOCIATED WITH 2800 01:55:50,680 --> 01:55:52,880 SHORT-LIVED OR LONG LIVED 2801 01:55:52,880 --> 01:55:54,840 PROTECTION, ON THE LEFT 2802 01:55:54,840 --> 01:55:56,240 ILLUSTRATED BY SOFT PADS, AND ON 2803 01:55:56,240 --> 01:55:59,960 THE RIGHT WE HAVE FACTORS 2804 01:55:59,960 --> 01:56:01,280 ASSOCIATED WITH LONG-LIVED 2805 01:56:01,280 --> 01:56:02,400 PROTECTION, ILLUSTRATED BY THE 2806 01:56:02,400 --> 01:56:08,400 SUIT OF ARMOR, THESE ARE THINGS 2807 01:56:08,400 --> 01:56:15,280 LIKE ANTIGEN VALENCE AND 2808 01:56:15,280 --> 01:56:15,600 UNKNOWNS. 2809 01:56:15,600 --> 01:56:17,160 THIS WORKSHOP AND FOCUS ON 2810 01:56:17,160 --> 01:56:18,680 DURABILITY OCCURRED IN THE 2811 01:56:18,680 --> 01:56:20,840 CONTEXT OF THE SARS-COV-2 2812 01:56:20,840 --> 01:56:23,440 PANDEMIC, AND I WANT TO USE THE 2813 01:56:23,440 --> 01:56:27,000 DATA FROM THE U.S. ON VACCINE 2814 01:56:27,000 --> 01:56:28,760 UPTAKE TO ILLUSTRATE THE VALUE 2815 01:56:28,760 --> 01:56:29,600 OF DURABLE RESPONSES. 2816 01:56:29,600 --> 01:56:31,040 ON THE LEFT WE HAVE PERCENTAGE 2817 01:56:31,040 --> 01:56:34,400 OF THE ADULT U.S. POPULATION 2818 01:56:34,400 --> 01:56:36,320 THAT COMPLETED PRIMARY SERIES, 2819 01:56:36,320 --> 01:56:39,400 IT'S RIGHT AROUND 70%. 2820 01:56:39,400 --> 01:56:42,320 WHEREAS ONLY 20% ACTUALLY UNDER 2821 01:56:42,320 --> 01:56:45,360 20% OF THE POPULATION RECEIVED 2822 01:56:45,360 --> 01:56:47,040 BIVALENT BOOSTER DOSE. 2823 01:56:47,040 --> 01:56:47,680 THIS DISCREPANCY REALLY 2824 01:56:47,680 --> 01:56:50,640 HIGHLIGHTS THE IMPORTANCE OF 2825 01:56:50,640 --> 01:56:54,400 ACHIEVING DURABLE PROTECTION TO 2826 01:56:54,400 --> 01:56:55,560 PREVENT INFECTIONS. 2827 01:56:55,560 --> 01:56:57,440 AT THE SAME TIME, AROUND THE 2828 01:56:57,440 --> 01:57:04,080 SAME TIME, YOU'VE HEARD SOME OF 2829 01:57:04,080 --> 01:57:08,400 THIS THIS MORNING, SIGNIFICANT 2830 01:57:08,400 --> 01:57:10,760 CLINICAL VACCINE ADVANCES, ON 2831 01:57:10,760 --> 01:57:13,920 THE LEFT FROM THE AMP TRIALS, 2832 01:57:13,920 --> 01:57:15,880 ESTABLISHED THAT PATH OF 2833 01:57:15,880 --> 01:57:17,440 ADMINISTRATION OF BROADLY 2834 01:57:17,440 --> 01:57:18,440 NEUTRALIZING ANTIBODY COULD 2835 01:57:18,440 --> 01:57:20,160 PREVENT ACQUISITION OF STRAINS 2836 01:57:20,160 --> 01:57:25,760 OF HIV THAT WERE SENSITIVE TO 2837 01:57:25,760 --> 01:57:27,720 NEUTRALIZATION BY THE ANTIBODIES 2838 01:57:27,720 --> 01:57:28,840 VRC-01 UNDER A CERTAIN 2839 01:57:28,840 --> 01:57:30,240 CONCENTRATION OF ANTIBODY, IN 2840 01:57:30,240 --> 01:57:33,840 THE TOP LINE YOU CAN SEE 2841 01:57:33,840 --> 01:57:35,800 PREVENTION EFFICACY AGAINST 2842 01:57:35,800 --> 01:57:37,200 SUSCEPTIBLE STRAINS. 2843 01:57:37,200 --> 01:57:39,240 IN ANOTHER TRIAL, THIS WAS A 2844 01:57:39,240 --> 01:57:41,680 PHASE 3 EFFICACY TRIAL, IN A 2845 01:57:41,680 --> 01:57:46,400 PHASE 1 TRIAL THEY DEMONSTRATED 2846 01:57:46,400 --> 01:57:50,640 THE ABILITY TO INDUCE VRC-01 2847 01:57:50,640 --> 01:57:52,440 CLASS B PRECURSORS, RECOGNIZING 2848 01:57:52,440 --> 01:58:02,960 THE BINDING SITE AND IMMUNOGEN 2849 01:58:06,920 --> 01:58:08,640 HERE eOD-GT8 IS ENGINEERED. 2850 01:58:08,640 --> 01:58:10,160 YOU CAN SEE THE NUMBER OF CLASS 2851 01:58:10,160 --> 01:58:16,480 B CELLS ON THE TOP ROW, BOTTOM 2852 01:58:16,480 --> 01:58:18,560 PERCENTAGE. 2853 01:58:18,560 --> 01:58:19,200 THESE EXPANDED SIGNIFICANTLY 2854 01:58:19,200 --> 01:58:21,320 AFTER IMMUNIZATION, AND THE TWO 2855 01:58:21,320 --> 01:58:23,440 COLORS ARE TWO DOSES OF VACCINE. 2856 01:58:23,440 --> 01:58:26,640 WHAT I ALSO WANT TO HIGHLIGHT 2857 01:58:26,640 --> 01:58:31,080 HERE IS THAT THEY SAW EXPANSION 2858 01:58:31,080 --> 01:58:33,560 OF CLASS B CELLS IN LYMPH NODE 2859 01:58:33,560 --> 01:58:34,560 GERMINAL CENTERS. 2860 01:58:34,560 --> 01:58:37,600 WE HAVE PROOF OF PRINCIPLE FOR 2861 01:58:37,600 --> 01:58:39,360 PROTECTIVE MECHANISM AGAINST 2862 01:58:39,360 --> 01:58:41,440 HIV, WITH BROADLY NEUTRALIZING 2863 01:58:41,440 --> 01:58:43,400 ANTIBODY ADMINISTRATION, AND 2864 01:58:43,400 --> 01:58:47,240 PROOF WE CAN INITIATE AND 2865 01:58:47,240 --> 01:58:48,640 EXPAND bNAb ANTIBODY 2866 01:58:48,640 --> 01:58:53,400 LINEAGES IN PEOPLE THROUGH 2867 01:58:53,400 --> 01:58:54,240 VACCINATION. 2868 01:58:54,240 --> 01:58:55,360 SO WITH THESE SUCCESSES, WE 2869 01:58:55,360 --> 01:58:58,280 THINK IT'S IMPORTANT TO FOCUS ON 2870 01:58:58,280 --> 01:59:00,160 THE DURABILITY OF VACCINE 2871 01:59:00,160 --> 01:59:01,800 PROTECTION AND VACCINE 2872 01:59:01,800 --> 01:59:02,080 RESPONSES. 2873 01:59:02,080 --> 01:59:04,080 A SUCCESSFUL HIV VACCINE MUST 2874 01:59:04,080 --> 01:59:05,280 ACHIEVE BROAD DURABLE AND 2875 01:59:05,280 --> 01:59:08,360 DEPENDING ON THE APPROACH OF 2876 01:59:08,360 --> 01:59:09,120 MECHANISM POTENTIALLY 2877 01:59:09,120 --> 01:59:10,520 STERILIZING IMMUNITY. 2878 01:59:10,520 --> 01:59:12,440 THIS WILL REQUIRE UNDERSTANDING 2879 01:59:12,440 --> 01:59:14,960 AND ENGINEERING DURABLE HIV 2880 01:59:14,960 --> 01:59:16,000 VACCINE TECHNOLOGY. 2881 01:59:16,000 --> 01:59:17,760 PARTICULARLY WITH INCREASING USE 2882 01:59:17,760 --> 01:59:19,160 OF mRNA PLATFORMS. 2883 01:59:19,160 --> 01:59:21,720 AS WE'VE SEEN FROM SARS-COV-2, 2884 01:59:21,720 --> 01:59:25,200 mRNA VACCINATION DOES NOT 2885 01:59:25,200 --> 01:59:26,840 ALWAYS RESULT IN LONG LIVED 2886 01:59:26,840 --> 01:59:28,920 SERUM ANTIBODY RESPONSES. 2887 01:59:28,920 --> 01:59:30,840 IT FOLLOWS INCREASING DURABILITY 2888 01:59:30,840 --> 01:59:32,800 OF A PROTECTIVE HIV VACCINE WILL 2889 01:59:32,800 --> 01:59:36,480 FURTHER REDUCE INCIDENCE OF HIV. 2890 01:59:36,480 --> 01:59:38,880 THE ENDURE INITIATIVE WILL 2891 01:59:38,880 --> 01:59:40,320 FOCUS -- WILL SUPPORT 2892 01:59:40,320 --> 01:59:41,640 HYPOTHESIS-DRIVEN BASIC RESEARCH 2893 01:59:41,640 --> 01:59:43,720 AND ITS APPLICATION TO 2894 01:59:43,720 --> 01:59:45,560 DEVELOPMENT OF HIV VACCINE 2895 01:59:45,560 --> 01:59:49,600 TECHNOLOGY, THAT CAN INDUCE 2896 01:59:49,600 --> 01:59:50,600 DURABLE IMMUNE RESPONSES. 2897 01:59:50,600 --> 01:59:53,000 THERE ARE A NUMBER OF GAPS IN 2898 01:59:53,000 --> 01:59:54,880 THE RESEARCH AND OPPORTUNITIES 2899 01:59:54,880 --> 01:59:56,400 TO ADDRESS THESE GAPS AND 2900 01:59:56,400 --> 01:59:57,480 ADVANCE THE FIELD. 2901 01:59:57,480 --> 02:00:00,600 FIRST OF THIEVES IS IN DEFINING 2902 02:00:00,600 --> 02:00:01,760 DURABLE VACCINE RESPONSES, SO 2903 02:00:01,760 --> 02:00:02,960 HOW DO WE DEFINE PROTECTION, 2904 02:00:02,960 --> 02:00:06,360 WHAT ARE SOME OF THE IMMUNE 2905 02:00:06,360 --> 02:00:07,280 MECHANISMS OF DURABLE RESPONSES, 2906 02:00:07,280 --> 02:00:10,840 NEXT GAP IS IN MEASURING DURABLE 2907 02:00:10,840 --> 02:00:12,480 RESPONSES, WITH FEW EXCEPTIONS 2908 02:00:12,480 --> 02:00:15,200 WE DON'T HAVE A GOOD HANDLE ON 2909 02:00:15,200 --> 02:00:17,520 MARKERS, CELL TYPES, OR TISSUES 2910 02:00:17,520 --> 02:00:19,280 TO ASSAY, OF COURSE WE TYPICALLY 2911 02:00:19,280 --> 02:00:22,120 LOOK IN THE BLOOD AND PBMCs 2912 02:00:22,120 --> 02:00:24,200 BUT AS YOU KNOW HIV EXPOSURE AND 2913 02:00:24,200 --> 02:00:26,720 INFECTION OCCUR IN THE RECTAL 2914 02:00:26,720 --> 02:00:27,560 AND VAGINAL MUCOSA. 2915 02:00:27,560 --> 02:00:31,080 THE LAST GAP IS IN ENGINEERING 2916 02:00:31,080 --> 02:00:32,920 DURABLE VACCINE RESPONSES. 2917 02:00:32,920 --> 02:00:33,560 UNDERSTANDING WHICH PROPERTIES 2918 02:00:33,560 --> 02:00:35,880 OF THE VACCINE SUCH AS PLATFORMS 2919 02:00:35,880 --> 02:00:38,640 AND EXAMPLES I'LL SHOW IN THE 2920 02:00:38,640 --> 02:00:41,040 NEXT SLIDE REALLY INDUCE MORE 2921 02:00:41,040 --> 02:00:41,920 DURABLE RESPONSES. 2922 02:00:41,920 --> 02:00:44,520 AND CRITICALLY WHAT ARE SOME OF 2923 02:00:44,520 --> 02:00:46,280 THE OPTIMAL EARLY AND NATURE 2924 02:00:46,280 --> 02:00:49,760 IMMUNE RESPONSES THAT CAN 2925 02:00:49,760 --> 02:00:52,200 PROGRAM LATER DURABILITY, THIS 2926 02:00:52,200 --> 02:00:52,920 IS PARTICULARLY IMPORTANT 2927 02:00:52,920 --> 02:00:54,600 BECAUSE UNDERSTANDING SOME OF 2928 02:00:54,600 --> 02:00:56,920 THESE FACTORS AND GETTING AN 2929 02:00:56,920 --> 02:00:58,440 EARLIER READ ON DURABILITY CAN 2930 02:00:58,440 --> 02:01:01,600 ALLOW RESEARCHERS AND DEVELOPERS 2931 02:01:01,600 --> 02:01:06,640 TO SIGNIFICANTLY ADVANCE VACCINE 2932 02:01:06,640 --> 02:01:08,080 DEVELOPMENT. 2933 02:01:08,080 --> 02:01:11,840 THIS IS DATA WHERE THEY HAVE A 2934 02:01:11,840 --> 02:01:15,080 LONGITUDINAL COHORT, AND THEY 2935 02:01:15,080 --> 02:01:16,160 HAVE MEASURED ANTIBODY TITERS TO 2936 02:01:16,160 --> 02:01:17,040 A NUMBER OF PATHOGENS THAT 2937 02:01:17,040 --> 02:01:22,400 PEOPLE IN THE U.S. ARE COMMONLY 2938 02:01:22,400 --> 02:01:23,600 VACCINATED FOR, DEMONSTRATING 2939 02:01:23,600 --> 02:01:25,560 THE VACCINE PLATFORM CAN AFFECT 2940 02:01:25,560 --> 02:01:27,240 THE DURABILITY OF PROTECTIVE 2941 02:01:27,240 --> 02:01:27,520 TITERS. 2942 02:01:27,520 --> 02:01:33,360 SO ON THE LEFT WE HAVE -- THEY 2943 02:01:33,360 --> 02:01:37,920 MEASURED TITERS AND CALCULATED 2944 02:01:37,920 --> 02:01:39,800 WHEN INDIVIDUAL'S TITER WOULD 2945 02:01:39,800 --> 02:01:41,440 DROP. 2946 02:01:41,440 --> 02:01:43,040 ON THE LEFT DIPHTHERIA AND 2947 02:01:43,040 --> 02:01:45,720 TETANUS, YOU CAN SEE A STEEP 2948 02:01:45,720 --> 02:01:47,360 DECLINE IN PROTECTION IN 2949 02:01:47,360 --> 02:01:50,000 ANTIBODY PROTECTION, AND THESE 2950 02:01:50,000 --> 02:01:51,480 ARE MONOVALENT PROTEIN VACCINES. 2951 02:01:51,480 --> 02:01:53,880 ON THE RIGHT IN GREEN AND BLUE 2952 02:01:53,880 --> 02:01:56,760 WE HAVE MEASLES AND RUBELLA WITH 2953 02:01:56,760 --> 02:01:59,280 LOWER RATES OF DECAY. 2954 02:01:59,280 --> 02:02:01,520 THESE ARE MULTIVALENT 2955 02:02:01,520 --> 02:02:02,160 REPLICATING VIRUSES. 2956 02:02:02,160 --> 02:02:04,080 VIRAL VACCINES OF THE THE FORMAT 2957 02:02:04,080 --> 02:02:06,520 OF THE VACCINE CAN REALLY IMPACT 2958 02:02:06,520 --> 02:02:09,440 THE DURABILITY OF THE ANTIBODY 2959 02:02:09,440 --> 02:02:12,720 RESPONSE AND PROTECTIVE ANTIBODY 2960 02:02:12,720 --> 02:02:13,400 RESPONSE. 2961 02:02:13,400 --> 02:02:23,240 HERE IS AN EXAMPLE FROM HIV, AND 2962 02:02:23,240 --> 02:02:23,880 THIS IMMUNOGEN EOD-GTIS RELATED 2963 02:02:23,880 --> 02:02:30,120 TO THE ONE I SHOWED EARLIER, 2964 02:02:30,120 --> 02:02:33,080 TARGETS VRC-01 CELLS AND 2965 02:02:33,080 --> 02:02:34,320 RECOGNIZES THE BINDING SITE ON 2966 02:02:34,320 --> 02:02:35,280 THE ENVELOPE. 2967 02:02:35,280 --> 02:02:36,680 THIS IS MOUSE DATA 2968 02:02:36,680 --> 02:02:39,760 WHAT THEY DID HERE WAS 2969 02:02:39,760 --> 02:02:40,720 RESEARCHERS PERFORMED ADOPTIVE 2970 02:02:40,720 --> 02:02:45,360 TRANSFER OF B CELLS EXPRESSING 2971 02:02:45,360 --> 02:02:48,200 THE VRC-01 PRECURSOR HEAVY AND 2972 02:02:48,200 --> 02:02:49,960 LIGHT CHAINS, AND POLYCLONAL B 2973 02:02:49,960 --> 02:02:53,240 CELLS TO ESTABLISH MORE 2974 02:02:53,240 --> 02:02:54,040 PHYSIOLOGICALLY RELEVANT 2975 02:02:54,040 --> 02:02:55,080 PRECURSOR FREQUENCY. 2976 02:02:55,080 --> 02:02:58,880 THESE MICE WERE THEN IMMUNIZED 2977 02:02:58,880 --> 02:03:03,960 WITH EODGT 2 AS A FORMER OR FOUR 2978 02:03:03,960 --> 02:03:05,360 COPIES OR 60 COPIES. 2979 02:03:05,360 --> 02:03:10,320 ON THE BOTTOM ARE DATA, YOU CAN 2980 02:03:10,320 --> 02:03:11,360 SEE A STRIKING DIFFERENCE 2981 02:03:11,360 --> 02:03:17,760 BETWEEN FORMER IN DARK BLUE AND 2982 02:03:17,760 --> 02:03:21,600 THE PURPLE MAGENTA COLOR WITH 2983 02:03:21,600 --> 02:03:23,760 60MER, EXPANSION OF THESE 2984 02:03:23,760 --> 02:03:26,640 TRANSGENIC B CELLS EXPRESSED IN 2985 02:03:26,640 --> 02:03:27,800 THE VRC-01 PRECURSOR, YOU CAN 2986 02:03:27,800 --> 02:03:29,560 SEE PERCENTAGE ON THE LEFT AND 2987 02:03:29,560 --> 02:03:33,680 IN THE MIDDLE THE NUMBER OF B 2988 02:03:33,680 --> 02:03:38,840 CELLS, IN THE GERMINAL CENTERS, 2989 02:03:38,840 --> 02:03:41,360 DIFFERENCE IN ENGAGEMENT AND 2990 02:03:41,360 --> 02:03:42,160 EXPANSION, LONGER TERM 2991 02:03:42,160 --> 02:03:43,680 MAINTENANCE IS STRIKING. 2992 02:03:43,680 --> 02:03:44,960 ANOTHER EXAMPLE OF VACCINE 2993 02:03:44,960 --> 02:03:47,360 PARAMETERS THAT CAN BE 2994 02:03:47,360 --> 02:03:49,600 MANIPULATED TO AFFECT THE 2995 02:03:49,600 --> 02:03:52,840 DURABILITY OF THE IMMUNE 2996 02:03:52,840 --> 02:03:53,120 RESPONSE. 2997 02:03:53,120 --> 02:03:54,720 THIS INITIATIVE HAS A FEW AREAS 2998 02:03:54,720 --> 02:03:56,800 OF INTEREST THAT CORRESPOND TO 2999 02:03:56,800 --> 02:03:58,760 GAPS I OUTLINED BEFORE. 3000 02:03:58,760 --> 02:04:01,600 THE FIRST IS IN DEFINING DURABLE 3001 02:04:01,600 --> 02:04:02,680 IMMUNITY. 3002 02:04:02,680 --> 02:04:05,520 SO THIS INCLUDES IDENTIFICATION 3003 02:04:05,520 --> 02:04:07,680 OF BIOMARKERS, SIGNATURES, 3004 02:04:07,680 --> 02:04:09,040 PREDICTORS OF DURABLE IMMUNE 3005 02:04:09,040 --> 02:04:09,920 RESPONSES, IDENTIFICATION AND 3006 02:04:09,920 --> 02:04:11,320 STUDY OF EARLY IMMUNE RESPONSES 3007 02:04:11,320 --> 02:04:13,880 THAT CAN PROGRAM LATER DURABLE 3008 02:04:13,880 --> 02:04:14,960 IMMUNITY, AND COMPARISONS OF 3009 02:04:14,960 --> 02:04:16,720 VACCINE PARAMETERS LIKE THOSE I 3010 02:04:16,720 --> 02:04:17,480 SHOWED YOU. 3011 02:04:17,480 --> 02:04:20,560 THE SECOND GAP IS IN MEASURING 3012 02:04:20,560 --> 02:04:21,760 DURABLE IMMUNITY, SO THIS 3013 02:04:21,760 --> 02:04:23,960 INCLUDES DEVELOPMENT OF ASSAYS 3014 02:04:23,960 --> 02:04:25,600 AND TECHNIQUES, INCLUDING 3015 02:04:25,600 --> 02:04:28,200 MUCOSAL SAMPLING SINCE WE KNOW 3016 02:04:28,200 --> 02:04:32,600 HOW IMPORTANT MUCOSAL IMMUNITY 3017 02:04:32,600 --> 02:04:34,520 IS FOR PREVENTION, AND STUDY AND 3018 02:04:34,520 --> 02:04:35,680 APPLICATION OF BIOMARKERS. 3019 02:04:35,680 --> 02:04:37,840 LAST GAP IN ENGINEERING DURABLE 3020 02:04:37,840 --> 02:04:39,560 IMMUNITY WILL INCLUDE THINGS 3021 02:04:39,560 --> 02:04:43,960 LIKE OPTIMIZATION OF VACCINE 3022 02:04:43,960 --> 02:04:46,560 PARAMETERS, LIKE ANTIGEN 3023 02:04:46,560 --> 02:04:50,600 VALUENTS, DISPLAY, PLATFORM, 3024 02:04:50,600 --> 02:04:52,280 OTHER PARAMETERS, STRATEGIES TO 3025 02:04:52,280 --> 02:04:54,560 INDUCE GERMINAL CENTERS AND 3026 02:04:54,560 --> 02:05:01,800 OPTIMIZATION OF EARLY IMMUNE 3027 02:05:01,800 --> 02:05:03,120 ACTIVATION PATHWAYS. 3028 02:05:03,120 --> 02:05:04,960 THIS SUPPORTS RESEARCH WITH 3029 02:05:04,960 --> 02:05:07,240 HUMAN, ANIMAL SAMPLES, CLINICAL 3030 02:05:07,240 --> 02:05:10,120 TRIALS NOT ALLOWED. 3031 02:05:10,120 --> 02:05:11,440 THE ENDURING INITIATIVE 3032 02:05:11,440 --> 02:05:12,760 COMPLEMENTS OTHER NIAID 3033 02:05:12,760 --> 02:05:14,480 PROGRAMS, FIRST IS THE DIVISION 3034 02:05:14,480 --> 02:05:16,560 OF AIDS ENGINEERING IMMUNITY TO 3035 02:05:16,560 --> 02:05:18,760 HIV THROUGH NEXT GENERATION 3036 02:05:18,760 --> 02:05:20,840 VACCINES, THIS HAS FOUR AWARDS, 3037 02:05:20,840 --> 02:05:24,760 AND NONE FOCUS ON VACCINE 3038 02:05:24,760 --> 02:05:25,120 DURABILITY. 3039 02:05:25,120 --> 02:05:27,600 DIVISION OF ALLERGY IMMUNOLOGY 3040 02:05:27,600 --> 02:05:29,160 AND TRANSPLANTATION RECENTLY 3041 02:05:29,160 --> 02:05:30,360 ISSUED MAINTAINING IMMUNITY 3042 02:05:30,360 --> 02:05:32,800 AFTER IMMUNIZATION AND THESE ARE 3043 02:05:32,800 --> 02:05:35,040 REALLY NICE MECHANISTIC STUDIES 3044 02:05:35,040 --> 02:05:37,360 OF HOW IMMUNITY AND IMMUNE 3045 02:05:37,360 --> 02:05:39,440 RESPONSES ARE MAINTAINED AFTER 3046 02:05:39,440 --> 02:05:40,640 VACCINATION. 3047 02:05:40,640 --> 02:05:42,080 BUT IT EXCLUDES HIV. 3048 02:05:42,080 --> 02:05:44,480 AND YOU WILL HEAR NEXT FROM 3049 02:05:44,480 --> 02:05:45,880 ANGELA ABOUT STRATEGIES FOR 3050 02:05:45,880 --> 02:05:48,400 CONTROLLED RELEASE OF HIV 3051 02:05:48,400 --> 02:05:48,640 VACCINE. 3052 02:05:48,640 --> 02:05:52,040 SO WHY DO WE NEED AN HIV CONCEPT 3053 02:05:52,040 --> 02:05:52,920 FOR THIS? 3054 02:05:52,920 --> 02:05:55,200 AS YOU'RE ALL PROBABLY MORE 3055 02:05:55,200 --> 02:05:57,400 AWARE, THERE'S AN EXTREMELY 3056 02:05:57,400 --> 02:06:00,120 NARROW WINDOW AFTER EXPOSURE TO 3057 02:06:00,120 --> 02:06:03,080 HIV, TO PREVENT ESTABLISHMENT OF 3058 02:06:03,080 --> 02:06:05,600 RESERVOIR, LIFELONG INFECTION, 3059 02:06:05,600 --> 02:06:06,920 ASSOCIATED SEQUELAE. 3060 02:06:06,920 --> 02:06:08,880 TREMENDOUS DIVERSITY OF HIV 3061 02:06:08,880 --> 02:06:11,480 STRAINS IS A PARTICULARLY 3062 02:06:11,480 --> 02:06:13,160 DIFFICULT OBSTACLE FOR VACCINE 3063 02:06:13,160 --> 02:06:14,880 DEVELOPMENT. 3064 02:06:14,880 --> 02:06:18,280 THERE'S NEED FOR PROTECTION IN 3065 02:06:18,280 --> 02:06:20,160 MUCOSAL TISSUE, HIV HAS COMPLEX 3066 02:06:20,160 --> 02:06:24,440 INTERACTIONS WITH THE HUMAN 3067 02:06:24,440 --> 02:06:26,520 IMMUNE SYSTEM, ABLATING CD4 3068 02:06:26,520 --> 02:06:28,480 COMPARTMENT WHEN HIV IS NOT 3069 02:06:28,480 --> 02:06:29,360 CONTROLLED, INCLUESING 3070 02:06:29,360 --> 02:06:30,440 INFLAMMATORY STATES. 3071 02:06:30,440 --> 02:06:32,200 FINALLY SOPHISTICATION OF HIV 3072 02:06:32,200 --> 02:06:33,080 VACCINE APPROACHES. 3073 02:06:33,080 --> 02:06:35,800 YOU HEARD THIS MORNING HOW WORK 3074 02:06:35,800 --> 02:06:38,880 ON HIV STRUCTURE OF THE 3075 02:06:38,880 --> 02:06:40,840 ENVELOPE, TRANSLATED IN PART TO 3076 02:06:40,840 --> 02:06:43,040 SUCCESS OF THE RSV VACCINE, SO 3077 02:06:43,040 --> 02:06:47,440 WE'VE HAD TO ADOPT SOME REALLY 3078 02:06:47,440 --> 02:06:50,080 THINK COMPLEX AND INTRICATE 3079 02:06:50,080 --> 02:06:53,760 APPROACHES TO SUCCESSFUL HIV 3080 02:06:53,760 --> 02:06:54,200 VACCINATION. 3081 02:06:54,200 --> 02:06:58,320 I WOULD LIKE TO THANK DOCTORS 3082 02:06:58,320 --> 02:07:00,760 GOEPFERT AND JEROME FOR 3083 02:07:00,760 --> 02:07:02,320 REVIEWING, PROVIDING FEEDBACK 3084 02:07:02,320 --> 02:07:03,160 THAT STRENGTHENED THE 3085 02:07:03,160 --> 02:07:03,600 INITIATIVE. 3086 02:07:03,600 --> 02:07:05,680 THEY SAID THIS IS AN IMPORTANT 3087 02:07:05,680 --> 02:07:07,760 AND TIMELY TOPIC, GIVEN THE 3088 02:07:07,760 --> 02:07:09,600 ADVANCES IN mRNA TECHNOLOGY 3089 02:07:09,600 --> 02:07:11,200 AND OTHER APPROACHES FOR HIV 3090 02:07:11,200 --> 02:07:12,400 IT'S CLEAR THAT DURABLE IMMUNITY 3091 02:07:12,400 --> 02:07:16,640 WILL BE CRITICAL TO ENDING THE 3092 02:07:16,640 --> 02:07:18,760 HIV PANDEMIC. 3093 02:07:18,760 --> 02:07:20,400 THE INITIATIVE ORIGINALLY READ 3094 02:07:20,400 --> 02:07:21,800 VACCINE PROTECTION AND THEY 3095 02:07:21,800 --> 02:07:24,480 ASKED US TO EXPAND THAT TO 3096 02:07:24,480 --> 02:07:25,240 VACCINE RESPONSES, IN PART 3097 02:07:25,240 --> 02:07:28,600 BECAUSE OF THE LACK OF DATA FOR 3098 02:07:28,600 --> 02:07:29,680 PROTECTION. 3099 02:07:29,680 --> 02:07:32,320 AND ALSO TO EXPAND THE SCOPE AND 3100 02:07:32,320 --> 02:07:33,640 LEARN FROM RESPONSES THAT MAY 3101 02:07:33,640 --> 02:07:37,600 NOT BE PROTECTIVE BUT THAT ARE 3102 02:07:37,600 --> 02:07:38,800 LONG LIVED. 3103 02:07:38,800 --> 02:07:40,760 THEY ALSO SAID WHILE 3104 02:07:40,760 --> 02:07:41,400 NEUTRALIZING ANTIBODIES HAVE A 3105 02:07:41,400 --> 02:07:43,600 CRITICAL ROLE THERE MAY BE OTHER 3106 02:07:43,600 --> 02:07:44,800 PROTECTIVE RESPONSES. 3107 02:07:44,800 --> 02:07:46,360 A MORE INCLUSIVE CONCEPT MAY 3108 02:07:46,360 --> 02:07:49,200 INVITE MORE NEW AND INNOVATIVE 3109 02:07:49,200 --> 02:07:49,640 APPROACHES. 3110 02:07:49,640 --> 02:07:52,160 WE COMPLETELY AGREE AND THE 3111 02:07:52,160 --> 02:07:54,120 FUNDING ANNOUNCEMENT WILL 3112 02:07:54,120 --> 02:07:58,400 CLARIFY THAT OTHER RESPONSES ARE 3113 02:07:58,400 --> 02:07:59,640 RESPONSIVE. 3114 02:07:59,640 --> 02:08:00,800 WE INCLUDED bNAbs TO 3115 02:08:00,800 --> 02:08:04,840 HIGHLIGHT PROGRESS IN VACCINE 3116 02:08:04,840 --> 02:08:05,160 DEVELOPMENT. 3117 02:08:05,160 --> 02:08:08,520 THERE WAS A POINT ABOUT 3118 02:08:08,520 --> 02:08:10,400 CORRELATING ENDPOINTS TO 3119 02:08:10,400 --> 02:08:11,920 BIOMARKERS AND SIGNATURES, AND 3120 02:08:11,920 --> 02:08:14,240 THE REVIEWERS HIGHLIGHTED IT WAS 3121 02:08:14,240 --> 02:08:15,000 PROBABLY NOT PARTICULARLY 3122 02:08:15,000 --> 02:08:17,400 RELEVANT FOR HIV SOY WE REMOVED 3123 02:08:17,400 --> 02:08:18,840 THAT AREA OF INTEREST. 3124 02:08:18,840 --> 02:08:21,680 AND FINALLY THEY ASKED US TO 3125 02:08:21,680 --> 02:08:24,960 EXPAND ON THE NEED FOR AN 3126 02:08:24,960 --> 02:08:25,960 HIV-SPECIFIC CONCEPT. 3127 02:08:25,960 --> 02:08:29,000 SO WE EXPANDED THAT RATIONALE 3128 02:08:29,000 --> 02:08:29,440 HERE. 3129 02:08:29,440 --> 02:08:31,200 SO I WILL CONCLUDE AND I'M HAPPY 3130 02:08:31,200 --> 02:08:34,040 TO TAKE QUESTIONS. 3131 02:08:34,040 --> 02:08:39,080 3132 02:08:39,080 --> 02:08:41,040 >> LOOKING AROUND THE ROOM, I 3133 02:08:41,040 --> 02:08:43,560 DON'T SEE -- ARE THERE ANY 3134 02:08:43,560 --> 02:08:46,400 QUESTIONS? 3135 02:08:46,400 --> 02:08:51,440 3136 02:08:51,440 --> 02:08:52,120 OKAY. 3137 02:08:52,120 --> 02:08:52,280 YES? 3138 02:08:52,280 --> 02:08:53,080 >> LOUIS SHACKLEFORD, HIV 3139 02:08:53,080 --> 02:09:01,200 VACCINE TRIALS NETWORK. 3140 02:09:01,200 --> 02:09:03,560 I WAS CURIOUS, SO UNDERSTANDING 3141 02:09:03,560 --> 02:09:07,400 THAT THIS IS KIND OF BENCH 3142 02:09:07,400 --> 02:09:09,160 SCIENCE, BUT ALSO FROM MY 3143 02:09:09,160 --> 02:09:11,800 PERSPECTIVE AND MY WORK IN 3144 02:09:11,800 --> 02:09:16,600 EXTERNAL RELATIONS SEEING THE 3145 02:09:16,600 --> 02:09:18,160 NEED FOR COMMUNITIES TO 3146 02:09:18,160 --> 02:09:21,320 UNDERSTAND WHEN IT COMES TO 3147 02:09:21,320 --> 02:09:22,720 VACCINES AND UNDERSTANDING THAT 3148 02:09:22,720 --> 02:09:25,400 FOLKS ARE A LITTLE BIT CONFUSED 3149 02:09:25,400 --> 02:09:28,440 AT HOW WE GOT A COVID-19 VACCINE 3150 02:09:28,440 --> 02:09:30,000 SO QUICKLY AND WE'RE STILL 3151 02:09:30,000 --> 02:09:32,160 WORKING ON AN HIV VACCINE. 3152 02:09:32,160 --> 02:09:38,840 AND SO I WOULD JUST -- MY 3153 02:09:38,840 --> 02:09:45,520 QUESTION TO YOU IS HAS ANY 3154 02:09:45,520 --> 02:09:46,720 THOUGHT BEEN GIVEN TO 3155 02:09:46,720 --> 02:09:47,720 COMMUNICATING THIS SCIENCE TO 3156 02:09:47,720 --> 02:09:49,920 COMMUNITIES, AND IF SO JUST 3157 02:09:49,920 --> 02:09:51,640 ENCOURAGING YOU TO TO THINK 3158 02:09:51,640 --> 02:09:53,720 ABOUT HOW TO COMMUNICATE THESE 3159 02:09:53,720 --> 02:09:54,560 THINGS TO COMMUNITIES BECAUSE 3160 02:09:54,560 --> 02:09:59,320 THERE IS A NEED AND WE SEE WHAT 3161 02:09:59,320 --> 02:10:00,720 HAPPENED WITH COVID-19 WHEN I 3162 02:10:00,720 --> 02:10:03,680 THINK WE GOT A VACCINE REALLY, 3163 02:10:03,680 --> 02:10:05,080 REALLY QUICKLY AND FOLKS WEREN'T 3164 02:10:05,080 --> 02:10:06,200 PREPARED TO UNDERSTAND THE 3165 02:10:06,200 --> 02:10:07,920 SCIENCE WHY THAT HAPPENED SO 3166 02:10:07,920 --> 02:10:08,240 QUICKLY. 3167 02:10:08,240 --> 02:10:10,040 AND SO THAT'S ALWAYS ON THE 3168 02:10:10,040 --> 02:10:13,160 FOREFRONT OF MY MIND NOW WHEN IT 3169 02:10:13,160 --> 02:10:15,320 COMES TO HIV VACCINES. 3170 02:10:15,320 --> 02:10:16,120 >> YEAH, ABSOLUTELY. 3171 02:10:16,120 --> 02:10:18,320 WE NEED TO DO A BETTER JOB 3172 02:10:18,320 --> 02:10:19,320 COMMUNICATING THE SCIENCE, I 3173 02:10:19,320 --> 02:10:21,080 COMPLETELY AGREE WITH YOU. 3174 02:10:21,080 --> 02:10:23,360 AND COMMUNICATING THAT COVID AND 3175 02:10:23,360 --> 02:10:26,960 HIV ARE REALLY, AS THEY SAY, TWO 3176 02:10:26,960 --> 02:10:27,360 DIFFERENT BEASTS. 3177 02:10:27,360 --> 02:10:30,480 BUT I HAVE TO SAY I AM NOT UP ON 3178 02:10:30,480 --> 02:10:31,200 STRATEGIES FOR COMMUNICATING, 3179 02:10:31,200 --> 02:10:32,880 AND I WOULD LIKE TO DO A BETTER 3180 02:10:32,880 --> 02:10:38,040 JOB OF THAT. 3181 02:10:38,040 --> 02:10:42,280 I ACTUALLY THINK THE HCVN DOES A 3182 02:10:42,280 --> 02:10:45,080 FANTASTIC JOB AND WE NEED TO DO 3183 02:10:45,080 --> 02:10:45,720 MORE OF THAT. 3184 02:10:45,720 --> 02:10:48,560 >> OTHER COMMENTS? 3185 02:10:48,560 --> 02:10:49,880 ANYTHING ONLINE? 3186 02:10:49,880 --> 02:10:50,520 NOPE, OKAY. 3187 02:10:50,520 --> 02:10:53,920 WELL, THANK YOU VERY MUCH. 3188 02:10:53,920 --> 02:10:57,560 AND EVERYBODY, PLEASE GO BACK TO 3189 02:10:57,560 --> 02:10:59,280 YOUR BALLOTS AND VOTE. 3190 02:10:59,280 --> 02:11:01,160 YOU MAY HAVE BEEN TIMED OUT, IF 3191 02:11:01,160 --> 02:11:03,560 YOU'VE BEEN ON FROM THE VERY 3192 02:11:03,560 --> 02:11:06,200 BEGINNING SO YOU HAVE TO REFRESH 3193 02:11:06,200 --> 02:11:09,800 OR GO BACK TO THE SITE AGAIN. 3194 02:11:09,800 --> 02:11:10,680 OKAY. 3195 02:11:10,680 --> 02:11:12,240 NOW WE'RE DOING THAT. 3196 02:11:12,240 --> 02:11:21,080 LET ME INTRODUCE THE NEXT 3197 02:11:21,080 --> 02:11:21,920 SPEAKER, ANGELA MALASPINA. 3198 02:11:21,920 --> 02:11:22,520 >> OKAY. 3199 02:11:22,520 --> 02:11:24,360 THANK YOU FOR THE OPPORTUNITY TO 3200 02:11:24,360 --> 02:11:26,200 TALK ABOUT THIS NEW CONCEPT, 3201 02:11:26,200 --> 02:11:28,600 STRATEGIES FOR CONTROLLED 3202 02:11:28,600 --> 02:11:34,640 RELEASE OF HIV VACCINE, I'M IN 3203 02:11:34,640 --> 02:11:45,160 THE VACCINE PROGRAM, TODAY MY 3204 02:11:50,600 --> 02:11:51,000 COLLEAGUES. 3205 02:11:51,000 --> 02:11:52,200 THE OBJECTIVE ADVANCE STRATEGIES 3206 02:11:52,200 --> 02:11:53,280 FOR CONTROLLED VACCINE RELEASE 3207 02:11:53,280 --> 02:11:58,320 TO IMPROVE IMMUNE RESPONSE TO 3208 02:11:58,320 --> 02:12:01,520 HIV PREVENTION, TREATMENT, CURE, 3209 02:12:01,520 --> 02:12:06,160 DEVELOP SIMPLIFIED SINGLE-SHOT 3210 02:12:06,160 --> 02:12:07,080 VACCINATION STRATEGY JUST, 3211 02:12:07,080 --> 02:12:09,040 BIPHASIC CODE WITH NO CLINICAL 3212 02:12:09,040 --> 02:12:13,600 TRIALS ALLOWED, FIVE YEARS, TWO 3213 02:12:13,600 --> 02:12:23,360 PHASES, R61 AFTER THREE YEARS, 3214 02:12:23,360 --> 02:12:27,720 R33 AFTER TWO YEARS, $750,000 3215 02:12:27,720 --> 02:12:29,080 PER YEAR. 3216 02:12:29,080 --> 02:12:31,800 AND CAN BE SPREAD ACROSS LIKE A 3217 02:12:31,800 --> 02:12:37,280 COUPLE STUDIES, AND THIS IS 3218 02:12:37,280 --> 02:12:43,160 TOTAL COST IN THE FIRST YEAR OF 3219 02:12:43,160 --> 02:12:48,960 THE R33, I'LL EXPLAIN THE 3220 02:12:48,960 --> 02:12:53,800 DELIVERY OF ANTI-VIRAL, WE CAN 3221 02:12:53,800 --> 02:12:56,320 DISCUSS ABOUT IT. 3222 02:12:56,320 --> 02:13:01,280 KEY FEATURES OF THE PROGRAM, 3223 02:13:01,280 --> 02:13:01,920 TWO-PHASE MILESTONE-DRIVEN 3224 02:13:01,920 --> 02:13:02,560 MECHANISM, MILESTONES 3225 02:13:02,560 --> 02:13:05,200 INCORPORATED INTO THE TERMS OF 3226 02:13:05,200 --> 02:13:07,800 THE AWARD, R61 PHASE TO OPTIMIZE 3227 02:13:07,800 --> 02:13:09,680 DELIVERY PLATFORMS FOR CONTROL 3228 02:13:09,680 --> 02:13:10,880 TEMPORAL AND SPATIAL RELEASE AND 3229 02:13:10,880 --> 02:13:16,880 IF THEY REACH THE MILESTONE MOVE 3230 02:13:16,880 --> 02:13:19,400 TO R33 PHASE, CLINICAL WORK OR 3231 02:13:19,400 --> 02:13:21,720 PRODUCT DEVELOPMENT, DEPENDS HOW 3232 02:13:21,720 --> 02:13:26,400 ADVANCED THEY ARE, AND BECAUSE 3233 02:13:26,400 --> 02:13:28,040 REALLY FACILITATE TRANSLATION. 3234 02:13:28,040 --> 02:13:30,680 THIS REASON WE REQUIRE 3235 02:13:30,680 --> 02:13:32,040 TRANSLATIONAL PARTNERSHIPS AMONG 3236 02:13:32,040 --> 02:13:33,080 ACADEMIA, INDUSTRY, AND/OR 3237 02:13:33,080 --> 02:13:33,480 GOVERNMENT. 3238 02:13:33,480 --> 02:13:36,920 AS I TOLD YOU WE WANT TO 3239 02:13:36,920 --> 02:13:38,200 BEHAVIORAL COMPONENT TO STUDY 3240 02:13:38,200 --> 02:13:45,000 END USER PREACH -- END USER 3241 02:13:45,000 --> 02:13:47,880 PREFERENCE FOR CONDENSED 3242 02:13:47,880 --> 02:13:48,840 IMMUNIZATION REGIMENS, 3243 02:13:48,840 --> 02:13:54,000 ENCOURAGED FOR R33 BUT NOT 3244 02:13:54,000 --> 02:13:54,520 REQUIRED. 3245 02:13:54,520 --> 02:13:55,440 STUDY DESIGN TRANSLATE INTO 3246 02:13:55,440 --> 02:13:59,880 PRODUCT TO HAVE SOLID UPTAKE AND 3247 02:13:59,880 --> 02:14:00,240 USE. 3248 02:14:00,240 --> 02:14:01,440 BACKGROUND, WE KNOW NATURAL 3249 02:14:01,440 --> 02:14:03,400 INFECTIONS EXPOSE THE BODY TO 3250 02:14:03,400 --> 02:14:04,920 INFLAMMATION AND ANTIGENS OVER 3251 02:14:04,920 --> 02:14:07,320 DAYS TO WEEKS, RESULTING IN 3252 02:14:07,320 --> 02:14:08,520 POTENT AND LONG-LASTING 3253 02:14:08,520 --> 02:14:11,280 PROTECTIVE IMMUNITY. 3254 02:14:11,280 --> 02:14:13,680 MOST CONVENTIONAL SUBUNIT 3255 02:14:13,680 --> 02:14:14,880 VACCINES DELIVERED IN BOLUS, 3256 02:14:14,880 --> 02:14:19,280 EXPOSE TO ANTIGENS HOURS OR 3257 02:14:19,280 --> 02:14:20,560 DAYS, AND OFTEN NECESSITATE 3258 02:14:20,560 --> 02:14:22,760 BOOSTER SHOTS TO INCREASE 3259 02:14:22,760 --> 02:14:23,600 EFFICACY. 3260 02:14:23,600 --> 02:14:25,480 FOR EXAMPLE WE THINK ABOUT THE 3261 02:14:25,480 --> 02:14:30,960 WAY WE WANT TO GENERATE BROADLY 3262 02:14:30,960 --> 02:14:33,640 NEUTRALIZING ANTIBODIES, WILL 3263 02:14:33,640 --> 02:14:36,680 LIKELY REQUIRE REPEATED 3264 02:14:36,680 --> 02:14:40,280 ADMINISTRATION OVER LONG 3265 02:14:40,280 --> 02:14:44,960 PERIODS, SHOWN HERE, PRIME AND 3266 02:14:44,960 --> 02:14:47,160 SEVERAL BOOSTS FOR bNAb 3267 02:14:47,160 --> 02:14:48,280 ACTIVITY. 3268 02:14:48,280 --> 02:14:51,360 WE BELIEVE IT'S IMPORTANT TO 3269 02:14:51,360 --> 02:14:51,920 HARNESS CONTROLLED RELEASE 3270 02:14:51,920 --> 02:15:02,440 PLATFORM THAT MIMIC INFECTION, 3271 02:15:03,120 --> 02:15:06,000 GENERATE bNAb RESPONSES, AND 3272 02:15:06,000 --> 02:15:07,200 DESIRABLE IMMUNE RESPONSES. 3273 02:15:07,200 --> 02:15:10,680 IMPACT ON T CELL APPROACHES AND 3274 02:15:10,680 --> 02:15:15,840 GENERATION OF CD8 T CELLS WILL 3275 02:15:15,840 --> 02:15:18,800 BE IMPORTANT, SO WE RECOGNIZE 3276 02:15:18,800 --> 02:15:22,960 HIV VACCINE ANTIGEN AND ADJUVANT 3277 02:15:22,960 --> 02:15:24,840 STILL REQUIRES OPTIMIZATION AND 3278 02:15:24,840 --> 02:15:26,040 SELECTION. 3279 02:15:26,040 --> 02:15:28,560 WE THINK ADVANCING SAFE 3280 02:15:28,560 --> 02:15:30,960 EFFECTIVE SOLUTIONS IS STILL AN 3281 02:15:30,960 --> 02:15:39,040 UNMET NEED THAT MAY IMPROVE 3282 02:15:39,040 --> 02:15:40,240 VACCINE EFFECTIVENESS AND 3283 02:15:40,240 --> 02:15:43,640 PRACTICALITY, FOR EXAMPLE 3284 02:15:43,640 --> 02:15:48,560 SINGLE-SHOT FORMULATION, BETTER 3285 02:15:48,560 --> 02:15:52,080 ADHERENCE, FEWER ADVERSE 3286 02:15:52,080 --> 02:15:55,240 REACTION, COST SAVINGS. 3287 02:15:55,240 --> 02:15:56,560 RECENT SCIENTIFIC ADVANCES, 3288 02:15:56,560 --> 02:16:00,960 MATERIALS BASED SCIENCE, NEW 3289 02:16:00,960 --> 02:16:03,600 RELEASE TECHNOLOGIES, DELIVERY 3290 02:16:03,600 --> 02:16:05,440 SYSTEMS, IMMUNOLOGY, TO TARGETED 3291 02:16:05,440 --> 02:16:07,160 RELEASE OF VACCINE COMPONENTS. 3292 02:16:07,160 --> 02:16:09,040 AND AGAIN AS I TOLD YOU VACCINE 3293 02:16:09,040 --> 02:16:10,360 COMPONENT MUST BE IN THE RIGHT 3294 02:16:10,360 --> 02:16:20,000 LOCATION AT THE RIGHT TIME TO 3295 02:16:20,000 --> 02:16:22,640 ORCHESTRATE RESPONSES, SPECIFIC 3296 02:16:22,640 --> 02:16:25,480 PRODUCTS, THINKING ABOUT 3297 02:16:25,480 --> 02:16:28,640 PRODUCTS LIKE HYDROGELS, HE 3298 02:16:28,640 --> 02:16:29,840 MICRONEEDLES, NANOPARTICLES IN 3299 02:16:29,840 --> 02:16:31,040 TIME FOR CONTROLLED INTERACTION 3300 02:16:31,040 --> 02:16:33,920 WITH IMMUNE CELLS. 3301 02:16:33,920 --> 02:16:35,760 YOU HEARD ABOUT THE SAME 3302 02:16:35,760 --> 02:16:37,720 PLATFORM FOR DELIVERY OF 3303 02:16:37,720 --> 02:16:39,800 ANTI-VIRAL, PROBABLY ALSO 3304 02:16:39,800 --> 02:16:41,360 MONOCLONAL ANTIBODIES, AND GOOD 3305 02:16:41,360 --> 02:16:44,280 THING, THEY CAN DELIVER VACCINE 3306 02:16:44,280 --> 02:16:47,800 CARGO OVER MONTHS, REGULATE 3307 02:16:47,800 --> 02:16:51,280 INNATE IMMUNE CELL ACTIVATION, 3308 02:16:51,280 --> 02:16:53,280 AND HYDROGEL INFECTION CAN 3309 02:16:53,280 --> 02:16:56,760 GENERATE VACCINE UPTAKE AND 3310 02:16:56,760 --> 02:16:58,080 IMPROVING ANTIGEN PRESENTATION, 3311 02:16:58,080 --> 02:16:59,160 TARGET LYMPH NODES, MUCOSA, 3312 02:16:59,160 --> 02:17:04,560 RELEVANT TISSUES. 3313 02:17:04,560 --> 02:17:07,360 ALSO CAN PRESERVE IMMUNOGEN 3314 02:17:07,360 --> 02:17:08,800 STRUCTURE, ENABLE ROOM STORAGE 3315 02:17:08,800 --> 02:17:09,600 TEMPERATURE. 3316 02:17:09,600 --> 02:17:11,000 WE THINK ABOUT CONTROLLED 3317 02:17:11,000 --> 02:17:13,080 RELEASE KINETICS WE THINK 3318 02:17:13,080 --> 02:17:15,040 KINETICS OF ANTI-JOHN/ADJUVANT 3319 02:17:15,040 --> 02:17:17,680 RELEASE AND PRESENTATION TO 3320 02:17:17,680 --> 02:17:19,640 IMMUNE CELLS TO AFFECT EFFICACY, 3321 02:17:19,640 --> 02:17:20,760 TO UNDERSTAND RELATIONSHIP 3322 02:17:20,760 --> 02:17:22,480 BETWEEN VACCINE RELEASE KINETICS 3323 02:17:22,480 --> 02:17:24,040 AND OVERALL IMMUNE RESPONSES 3324 02:17:24,040 --> 02:17:26,560 WILL AID IN DEVELOPING OPTIMIZED 3325 02:17:26,560 --> 02:17:31,080 DELIVERY PLATFORM. 3326 02:17:31,080 --> 02:17:35,440 HERE WE SEE EXAMPLE WORK FROM 3327 02:17:35,440 --> 02:17:37,520 TAM IRVINE, IMPROVE ANTIBODY 3328 02:17:37,520 --> 02:17:40,480 RESPONSE IN MICE, COMPARE HERE 3329 02:17:40,480 --> 02:17:44,000 TRADITIONAL BOLUS WITH REPEATED 3330 02:17:44,000 --> 02:17:47,600 INJECTION, SPECIFICALLY THEY 3331 02:17:47,600 --> 02:17:49,560 SHOW EXPONENTIAL INCREASE, 3332 02:17:49,560 --> 02:17:52,280 FRACTIONATED DOSING OR DELIVERY, 3333 02:17:52,280 --> 02:17:57,760 IS IMPACTING RESPONSE, NEW 3334 02:17:57,760 --> 02:17:58,960 RESPONSES, REALLY CREATING 3335 02:17:58,960 --> 02:17:59,680 BETTER ANTIGEN RETENTION. 3336 02:17:59,680 --> 02:18:03,720 IF WE LOOK AT THE ANTIBODY 3337 02:18:03,720 --> 02:18:07,560 OUTPUT WE CAN SEE EXPONENTIAL 3338 02:18:07,560 --> 02:18:09,880 INCREASE, 13 TIMES MORE OUTPUT 3339 02:18:09,880 --> 02:18:12,080 OF ANTIBODIES WHEN COMPARING TO 3340 02:18:12,080 --> 02:18:12,280 BOLUS. 3341 02:18:12,280 --> 02:18:14,040 IT'S REALLY LIKE A BIG 3342 02:18:14,040 --> 02:18:15,600 DIFFERENCE. 3343 02:18:15,600 --> 02:18:19,080 AND WHEN WE THINK ABOUT 3344 02:18:19,080 --> 02:18:20,040 SUSTAINED RELEASE, FRAMING 3345 02:18:20,040 --> 02:18:26,280 VACCINE DELIVERY IN DIFFERENT 3346 02:18:26,280 --> 02:18:31,240 WAYS, WE THINK ABOUT SINGLE 3347 02:18:31,240 --> 02:18:33,200 SUSTAINED RELEASE, MORE STUDIED, 3348 02:18:33,200 --> 02:18:37,240 WE THINK ABOUT DELIVERY LIKE 3349 02:18:37,240 --> 02:18:38,240 OSMOTIC PUMPS, HYDROGEL, 3350 02:18:38,240 --> 02:18:41,960 MICROPARTICLE, WANT TO MIMIC 3351 02:18:41,960 --> 02:18:44,320 PRIME AND BOOST, WITH PULSATILE 3352 02:18:44,320 --> 02:18:49,600 RELEASE AND A LOT OF DATA IN 3353 02:18:49,600 --> 02:18:55,000 PRE-CLINICAL, LAYER BY LAYER 3354 02:18:55,000 --> 02:18:56,000 MICROPARTICLE, MICRONEEDLE. 3355 02:18:56,000 --> 02:19:03,480 SO BUT THERE'S A LOT OF 3356 02:19:03,480 --> 02:19:10,920 PROMISING BUT NOT MUCH EFFICACY, 3357 02:19:10,920 --> 02:19:14,120 OBSTACLES REMAIN, DIFFICULTY 3358 02:19:14,120 --> 02:19:15,120 MAINTAINING STABILITY, 3359 02:19:15,120 --> 02:19:17,760 BIOACTIVITY, CONTROLLING DESIRED 3360 02:19:17,760 --> 02:19:19,040 RELEASE KINETICS, SELECTING 3361 02:19:19,040 --> 02:19:23,120 BIODEGRADE AL SAFE FORMULATION, 3362 02:19:23,120 --> 02:19:24,080 AND ALSO EVENTUALLY 3363 02:19:24,080 --> 02:19:25,720 MANUFACTURING CONSTRAINT LIKE 3364 02:19:25,720 --> 02:19:29,880 SCALING UP. 3365 02:19:29,880 --> 02:19:31,840 THINKING ABOUT DELIVERY, CONCERN 3366 02:19:31,840 --> 02:19:34,040 ABOUT CD8 T CELLS, ENCOURAGING 3367 02:19:34,040 --> 02:19:41,400 RESULTS, THIS IS A LOT OF THE 3368 02:19:41,400 --> 02:19:44,760 WORK PUBLISHED WITH DELIVERY, 3369 02:19:44,760 --> 02:19:46,720 GERMINAL CENTERS, ANTIBODY 3370 02:19:46,720 --> 02:19:51,240 RESPONSES, THIS IS THE COMPARE 3371 02:19:51,240 --> 02:19:51,880 CONVENTIONAL VERSUS SLOW 3372 02:19:51,880 --> 02:19:54,360 DELIVERY OSMOTIC PUMPS OR 3373 02:19:54,360 --> 02:19:55,960 FRACTIONATED DELIVERY. 3374 02:19:55,960 --> 02:20:02,960 IT WAS PROLONGED ANTIGEN 3375 02:20:02,960 --> 02:20:03,920 EXPOSURE, ENVELOPE RETAINING 3376 02:20:03,920 --> 02:20:08,640 WITH THE RIGHT STRUCTURE FOR 3377 02:20:08,640 --> 02:20:11,600 LONGER, INCREASE SO PATTIC 3378 02:20:11,600 --> 02:20:14,080 HYPERMUTATION AND AFFINITY 3379 02:20:14,080 --> 02:20:16,080 MATURATION, GREATER ANTIBODY 3380 02:20:16,080 --> 02:20:17,920 DIVERSITY AND NEUTRALIZING 3381 02:20:17,920 --> 02:20:18,320 ANTIBODY TITERS. 3382 02:20:18,320 --> 02:20:23,440 IF YOU HAVE A LONG PRIMING, 3383 02:20:23,440 --> 02:20:25,960 AGAIN IN MONKEYS, THE SAME 3384 02:20:25,960 --> 02:20:29,640 DOSES, YOU DO THIS MUCH LATER 3385 02:20:29,640 --> 02:20:33,160 ON, THIS IS A PAPER, PROLONGED 3386 02:20:33,160 --> 02:20:37,080 MATURATION, YOU'LL SEE MORE 3387 02:20:37,080 --> 02:20:46,480 CONSISTENT AND ROBUST BROADER, 3388 02:20:46,480 --> 02:20:50,800 NOT BROADLY, TITER, LEADING DATA 3389 02:20:50,800 --> 02:20:52,640 SUPPORT THIS DELIVERY. 3390 02:20:52,640 --> 02:20:56,520 HERE THERE'S A LOT MORE PLATFORM 3391 02:20:56,520 --> 02:21:03,120 THERE, LIKE -- WE WOULD LIKE TO 3392 02:21:03,120 --> 02:21:06,800 EXPLORE THE STAGE, THIS IS 3393 02:21:06,800 --> 02:21:08,000 CALLED STAMPED ASSEMBLY POLYMER 3394 02:21:08,000 --> 02:21:15,240 LAYER, AND THESE ARE LIKE A 3395 02:21:15,240 --> 02:21:16,240 SYRINGE CONTAIN SEVERAL 3396 02:21:16,240 --> 02:21:19,200 MICROPARTICLE, DELAYED PULSE OF 3397 02:21:19,200 --> 02:21:22,360 ANTIGEN TO IMITATE CONVENTIONAL 3398 02:21:22,360 --> 02:21:24,320 BOLUS INFECTION, THE DELIVERY OF 3399 02:21:24,320 --> 02:21:25,080 DIFFERENT ANTIGEN. 3400 02:21:25,080 --> 02:21:29,360 IF YOU LOOK, THIS IS THE RED 3401 02:21:29,360 --> 02:21:31,920 LINE, WHAT YOU OBTAIN, IN PURPLE 3402 02:21:31,920 --> 02:21:34,560 IS REALLY CORRESPONDING TO TWO 3403 02:21:34,560 --> 02:21:37,040 BOLUS VACCINATION WITH DOUBLE 3404 02:21:37,040 --> 02:21:39,400 DOSE OF ANTIGENE REALLY 3405 02:21:39,400 --> 02:21:45,400 PERFORMING WELL, SIMILAR BUT 3406 02:21:45,400 --> 02:21:47,040 CORE SHELL MICRO NEEDLE, 3407 02:21:47,040 --> 02:21:51,440 MULTIPLE VACCINE PAYLOAD, FULLY 3408 02:21:51,440 --> 02:21:57,320 IMPLANTED INTO THE SKIN, 3409 02:21:57,320 --> 02:21:57,800 MULTI-BURST PROFILE. 3410 02:21:57,800 --> 02:22:03,760 A LOT OF WORK FROM OUR 3411 02:22:03,760 --> 02:22:06,960 COLLEAGUES IN DAIDS, NIMH, SINCE 3412 02:22:06,960 --> 02:22:08,560 2015, SUSTAINED RELEASE FOR 3413 02:22:08,560 --> 02:22:14,080 PREVENTION OF HIV OR TREATMENT 3414 02:22:14,080 --> 02:22:16,240 OF LATENT TB/HBV. 3415 02:22:16,240 --> 02:22:20,320 NOW MORE RESEARCH ON DEVELOPMENT 3416 02:22:20,320 --> 02:22:22,080 NEXT GENERATION DEVICES 3417 02:22:22,080 --> 02:22:25,600 MATERIALS-BASED PLATFORM MORE 3418 02:22:25,600 --> 02:22:29,440 ADMINISTRATION OF HIV-1 3419 02:22:29,440 --> 02:22:30,200 bNAbS. 3420 02:22:30,200 --> 02:22:36,120 AND THEN ENGINEERING DURABLE HIV 3421 02:22:36,120 --> 02:22:41,000 VACCINE RESPONSES, THEY HAVE 3422 02:22:41,000 --> 02:22:42,320 MUCH BROADER SCOPE. 3423 02:22:42,320 --> 02:22:48,640 WHAT ARE WE DOING IN OUR 3424 02:22:48,640 --> 02:22:51,520 PORTFOLIO, ESPECIALLY HIV 3425 02:22:51,520 --> 02:22:53,360 PREVENTION, AND IN DAIT. 3426 02:22:53,360 --> 02:22:57,000 EXAMPLE OF WORK IN THE SON 3427 02:22:57,000 --> 02:22:59,720 COURTA FOR HIV VACCINE AND 3428 02:22:59,720 --> 02:23:02,120 DEVELOPMENT, CONTRACT WITH DAIDS 3429 02:23:02,120 --> 02:23:05,080 AND DAIT, THE STAGE WE COMPARE 3430 02:23:05,080 --> 02:23:09,240 THE SAME CONSTRUCT, CAN BE 3431 02:23:09,240 --> 02:23:13,960 VACCINE, HIV ENVELOPE DELIVERED 3432 02:23:13,960 --> 02:23:20,800 BY BOLUS, AND NOW INCLUDE 3433 02:23:20,800 --> 02:23:31,240 OTHERS, HYDROGEL, WE HAVE THIS 3434 02:23:31,240 --> 02:23:37,320 WAY OF DELIVERY, 3435 02:23:37,320 --> 02:23:39,400 (INDISCERNIBLE) SLOWLY. 3436 02:23:39,400 --> 02:23:41,720 FREEZE DRIED FORMULATION, 3437 02:23:41,720 --> 02:23:43,720 DIFFERENT LAYERS IN THE RELEASE 3438 02:23:43,720 --> 02:23:46,560 AT DIFFERENT TIMES, HAVING MORE 3439 02:23:46,560 --> 02:23:48,520 OF A PULSATILE WAY TO DO IT. 3440 02:23:48,520 --> 02:23:56,840 WHAT ARE WE DOING IN THE 3441 02:23:56,840 --> 02:23:59,080 CLINICAL VACCINE PIPELINE? 3442 02:23:59,080 --> 02:24:09,600 WE'RE DOING IMMUNOGENICITY OF 3443 02:24:11,880 --> 02:24:14,880 BOLUS VERSUS FRACTIONATED 3444 02:24:14,880 --> 02:24:22,640 DOSING/DELIVERY. 3445 02:24:22,640 --> 02:24:29,640 CLINICAL TRIAL BEFORE THE END OF 3446 02:24:29,640 --> 02:24:37,640 THIS YEAR, BOTH ARE TRIMER OR 3447 02:24:37,640 --> 02:24:38,760 SCAFFOLDING, VULNERABILITY IN 3448 02:24:38,760 --> 02:24:45,120 HIV, AND THIS IS STUDY FOR 3449 02:24:45,120 --> 02:24:51,120 VRC-01, THE PRIME HAS A LOT OF 3450 02:24:51,120 --> 02:24:53,960 ESCALATING DOSES. 3451 02:24:53,960 --> 02:24:57,160 IN THE CASE, THEY WANT TO MIMIC 3452 02:24:57,160 --> 02:25:00,760 VIRAL REPLICATION, MORE 3453 02:25:00,760 --> 02:25:03,480 COMPLICATED REGIMEN. 3454 02:25:03,480 --> 02:25:09,040 THEY CALL IT RAPIDVAX. 3455 02:25:09,040 --> 02:25:15,680 AFTER THE PRIME THEY GO FASTER, 3456 02:25:15,680 --> 02:25:18,040 ONLY THREE, D 4, 8, 15. 3457 02:25:18,040 --> 02:25:19,000 IT'S NOT PRACTICAL. 3458 02:25:19,000 --> 02:25:21,840 WE WANTED TO WORK ON MORE 3459 02:25:21,840 --> 02:25:22,640 PRACTICAL WAYS. 3460 02:25:22,640 --> 02:25:27,400 WHAT WE'RE DOING AS WELL, SOME 3461 02:25:27,400 --> 02:25:29,440 STUDIES LIKE HVTN 144 IN ANIMAL 3462 02:25:29,440 --> 02:25:33,600 MODEL, WE HOPE WILL BE ABLE TO 3463 02:25:33,600 --> 02:25:39,400 ESTABLISH PREDICTIVE VALUE ON 3464 02:25:39,400 --> 02:25:44,880 ANIMAL MODELS, AND HUMAN TRIAL 3465 02:25:44,880 --> 02:25:49,320 WE WANTED TO LEVERAGE THIS 3466 02:25:49,320 --> 02:25:51,960 PLATFORM AND EVALUATE IN SMALL 3467 02:25:51,960 --> 02:25:53,400 ANIMAL MODELS, WE DON'T HAVE A 3468 02:25:53,400 --> 02:25:56,560 LOT OF DATA IN THIS AREA. 3469 02:25:56,560 --> 02:25:59,720 IT REQUIRED DEEP IMMUNOLOGIC 3470 02:25:59,720 --> 02:26:00,600 INVESTIGATION, ANTIGEN FOR 3471 02:26:00,600 --> 02:26:04,080 SUSTAINED RELEASE FOR A LONG 3472 02:26:04,080 --> 02:26:05,840 TIME. 3473 02:26:05,840 --> 02:26:10,440 WHAT ABOUT ADJUVANT? 3474 02:26:10,440 --> 02:26:11,760 ALSO STUDYING AGAINST CURRENT 3475 02:26:11,760 --> 02:26:13,720 OPTIMAL VACCINE, IF I DO PRIME 3476 02:26:13,720 --> 02:26:15,680 BOOST AND WITH PERFECT ADJUVANT 3477 02:26:15,680 --> 02:26:17,560 IS THE CONTROL OF THIS PLATFORM 3478 02:26:17,560 --> 02:26:19,520 BETTER OR SAME AT LEAST BUT NOT 3479 02:26:19,520 --> 02:26:30,040 INFERIOR, OTHERWISE WE HAVE A 3480 02:26:31,080 --> 02:26:31,440 PROBLEM. 3481 02:26:31,440 --> 02:26:33,400 ASSESSING ADVANTAGES AND EFFECTS 3482 02:26:33,400 --> 02:26:35,360 OF PROLONGED VACCINE DELIVERY, 3483 02:26:35,360 --> 02:26:35,760 LONGITUDINALLY. 3484 02:26:35,760 --> 02:26:37,600 IT'S IMPORTANT TO FOLLOW IT LONG 3485 02:26:37,600 --> 02:26:37,800 TERM. 3486 02:26:37,800 --> 02:26:39,320 IT IS EARLY STAGES. 3487 02:26:39,320 --> 02:26:43,040 THE IDEA TO HARNESS PROGRESS 3488 02:26:43,040 --> 02:26:44,160 TOWARDS CONTROLLED RELEASE 3489 02:26:44,160 --> 02:26:45,920 TECHNOLOGY TO DEVELOP SIMPLIFIED 3490 02:26:45,920 --> 02:26:48,280 OR SINGLE SHOT VACCINATION 3491 02:26:48,280 --> 02:26:53,080 STRATEGIES THAT MIMIC 3492 02:26:53,080 --> 02:26:57,160 MULTI-DOSE, PRIME-BOOST REGIMENS 3493 02:26:57,160 --> 02:26:57,600 OR INFECTION. 3494 02:26:57,600 --> 02:27:00,920 IF YOU CAN MIMIC VIRAL VACCINE 3495 02:27:00,920 --> 02:27:02,760 WITH ENGINEERING IT, WOULD BE 3496 02:27:02,760 --> 02:27:04,320 VERY EXCITING, FOR EXAMPLE, FOR 3497 02:27:04,320 --> 02:27:06,280 THE T CELL APPROACHES. 3498 02:27:06,280 --> 02:27:08,000 ALSO OF COURSE ADVANCE PRACTICAL 3499 02:27:08,000 --> 02:27:09,120 SOLUTION FOR CLINICAL USE, 3500 02:27:09,120 --> 02:27:11,320 AMOUNT MIZEED FOR ROUTE OF 3501 02:27:11,320 --> 02:27:17,560 ADMINISTRATION, NUMBER OF DOSES, 3502 02:27:17,560 --> 02:27:19,640 COST, SUBJECT TOLERABILITY. 3503 02:27:19,640 --> 02:27:23,560 WE WANT PLATFORMS OUT THERE FOR 3504 02:27:23,560 --> 02:27:26,960 A WHILE, IMMUNOLOGY ASPECT, 3505 02:27:26,960 --> 02:27:28,280 TRANSLATIONAL PARTNERSHIP. 3506 02:27:28,280 --> 02:27:33,200 33 PHASE, EVALUATION IN ANIMAL 3507 02:27:33,200 --> 02:27:35,600 MODELS, BUT EVEN MORE ADVANCED 3508 02:27:35,600 --> 02:27:41,960 WE WANT TO LOOK AT MAINTENANCE 3509 02:27:41,960 --> 02:27:43,960 THROUGHOUT DELIVERY PERIOD, 3510 02:27:43,960 --> 02:27:44,920 FEASIBILITY OF GMP 3511 02:27:44,920 --> 02:27:45,240 MANUFACTURING. 3512 02:27:45,240 --> 02:27:48,640 AND AS YOU HEARD FROM PATRICK, 3513 02:27:48,640 --> 02:27:52,160 BEGIN TO UNDERSTAND END USER, 3514 02:27:52,160 --> 02:27:55,640 AND USE THIS INFORMATION TO 3515 02:27:55,640 --> 02:27:58,080 REFINE DEVELOPMENT. 3516 02:27:58,080 --> 02:27:59,800 IF YOU'RE MORE ADVANCED, THE 3517 02:27:59,800 --> 02:28:02,320 QUESTION ABOUT IS TECHNOLOGY 3518 02:28:02,320 --> 02:28:04,000 AMENABLE TO COMBINATION VACCINE? 3519 02:28:04,000 --> 02:28:09,320 WHAT LEVEL OF INJECT 3520 02:28:09,320 --> 02:28:10,640 INJECTABILITY, CAN WE SCALE UP? 3521 02:28:10,640 --> 02:28:21,200 I WANT TO THANK OUR REVIEWERS, 3522 02:28:25,600 --> 02:28:26,640 TO RECOMMEND FOR APPROVAL, 3523 02:28:26,640 --> 02:28:29,360 TIMELY GIVEN IMMUNOLOGY AND 3524 02:28:29,360 --> 02:28:32,680 CRITICAL TO DEVELOPING 3525 02:28:32,680 --> 02:28:33,400 PROTECTION BY RESPONSES, 3526 02:28:33,400 --> 02:28:36,920 POTENTIALLY T-CELL RESPONSES ON 3527 02:28:36,920 --> 02:28:38,520 IMPROVING AND EMERGING, 3528 02:28:38,520 --> 02:28:41,120 RECOMMEND TO CLEARLY DELINEATING 3529 02:28:41,120 --> 02:28:41,760 MILESTONES, PARTICULARLY AROUND 3530 02:28:41,760 --> 02:28:42,720 USING APPROPRIATE SMALL ANIMAL 3531 02:28:42,720 --> 02:28:44,560 MODELS AND HOW TO DEFINE 3532 02:28:44,560 --> 02:28:47,320 RELEVANT ANTIBODY OR T 3533 02:28:47,320 --> 02:28:48,160 CELL/INNATE OUTCOMES AND MOVE 3534 02:28:48,160 --> 02:28:50,160 FORWARD BECAUSE WE DON'T HAVE 3535 02:28:50,160 --> 02:28:52,880 PROTECTION, WE'RE NOT SURE, WE 3536 02:28:52,880 --> 02:28:55,600 HAVE TO MAKE SURE THE MICE ARE 3537 02:28:55,600 --> 02:28:59,560 WELL SET. 3538 02:28:59,560 --> 02:29:01,640 SUPPORTED BEHAVIORAL RESEARCH 3539 02:29:01,640 --> 02:29:07,680 COMPONENT IN R33 PHASE, USING 3540 02:29:07,680 --> 02:29:09,000 THIS BEHAVIORAL METHOD TO 3541 02:29:09,000 --> 02:29:10,520 APPROPRIATE STAGE OF PRODUCT 3542 02:29:10,520 --> 02:29:12,720 DEVELOPMENT, SO DEPENDS HOW 3543 02:29:12,720 --> 02:29:15,440 ADVANCED IT IS OR IT IS NOT. 3544 02:29:15,440 --> 02:29:17,840 GIVEN CONCEPT IS FIRST ATTEMPT 3545 02:29:17,840 --> 02:29:20,480 TO LEVERAGE AND GAIN BASE 3546 02:29:20,480 --> 02:29:22,560 KNOWLEDGE OF VARIOUS APPROACHES, 3547 02:29:22,560 --> 02:29:28,760 THEY RECOMMEND NEED FOR 3548 02:29:28,760 --> 02:29:29,280 COMPREHENSIVE IMMUNOLOGY, 3549 02:29:29,280 --> 02:29:31,720 LONGITUDINALLY IN TISSUES AS 3550 02:29:31,720 --> 02:29:34,600 WELL AS MUCOSA, EVALUATING 3551 02:29:34,600 --> 02:29:36,120 ADVANTAGES AND DETRIMENTAL 3552 02:29:36,120 --> 02:29:37,960 EFFECTS OF DELIVERY STRATEGIES 3553 02:29:37,960 --> 02:29:40,400 INCLUDING EXTENDED ANTIGEN AND 3554 02:29:40,400 --> 02:29:43,000 ADJUVANTS TO IMMUNE CELL 3555 02:29:43,000 --> 02:29:45,520 EXHAUSTION OR IMMUNE TOLERANCE, 3556 02:29:45,520 --> 02:29:47,720 AND INCLUDING ROBUST BENCHMARK, 3557 02:29:47,720 --> 02:29:50,360 CURRENT OPTIMAL VACCINE, STUDY 3558 02:29:50,360 --> 02:29:53,840 LONGITUDINALLY IN PARALLEL TO 3559 02:29:53,840 --> 02:29:57,880 NEW PLATFORM, IDENTIFY DUE TO 3560 02:29:57,880 --> 02:29:59,200 SUSTAINED/PULSATILED AM VERSUS 3561 02:29:59,200 --> 02:30:00,760 BETTER ANTIGEN OR ADJUVANT. 3562 02:30:00,760 --> 02:30:01,520 I'M DONE. 3563 02:30:01,520 --> 02:30:05,880 I'M READY FOR QUESTIONS YOU MAY 3564 02:30:05,880 --> 02:30:06,200 HAVE. 3565 02:30:06,200 --> 02:30:06,480 THANK YOU. 3566 02:30:06,480 --> 02:30:12,240 >> YOU CAN TAKE A BREATH NOW. 3567 02:30:12,240 --> 02:30:12,880 >> THANK YOU. 3568 02:30:12,880 --> 02:30:14,680 >> YOU SPED RIGHT THROUGH IT. 3569 02:30:14,680 --> 02:30:16,920 DO WE HAVE A QUESTION? 3570 02:30:16,920 --> 02:30:17,920 >> THANK YOU. 3571 02:30:17,920 --> 02:30:20,920 TO FOLLOW UP ON EARLIER THEMES 3572 02:30:20,920 --> 02:30:22,640 AND QUESTIONS, THE BEHAVIORAL 3573 02:30:22,640 --> 02:30:24,120 COMPONENT, YOU INDICATED WAS 3574 02:30:24,120 --> 02:30:28,360 GOING TO BE OPTIONAL, IF I 3575 02:30:28,360 --> 02:30:30,120 UNDERSTOOD CORRECTLY, AND 3576 02:30:30,120 --> 02:30:32,960 OBVIOUSLY I AGREED WITH THE 3577 02:30:32,960 --> 02:30:34,600 REVIEWERS THAT SUPPORTS 3578 02:30:34,600 --> 02:30:37,640 BEHAVIORAL COMPONENT AND I WOULD 3579 02:30:37,640 --> 02:30:40,720 CERTAINLY SUGGEST THAT IT BE A 3580 02:30:40,720 --> 02:30:42,600 PART OR MANDATORY COMPONENT. 3581 02:30:42,600 --> 02:30:44,800 WE JUST NEED TO KNOW MORE ABOUT 3582 02:30:44,800 --> 02:30:48,160 THE EXPERIENCE OF THE USER IN 3583 02:30:48,160 --> 02:30:50,320 THESE STUDIES TO INFORM THE 3584 02:30:50,320 --> 02:30:52,760 FIELD GOING FORWARD IN THE NEXT 3585 02:30:52,760 --> 02:30:52,960 STUDY. 3586 02:30:52,960 --> 02:30:54,400 IF THERE'S ANY WAY TO MAKE THAT 3587 02:30:54,400 --> 02:30:56,440 MANDATORY OR PART OF THE STUDY 3588 02:30:56,440 --> 02:30:58,680 REQUIREMENTS IT WOULD BE 3589 02:30:58,680 --> 02:30:58,960 RECOMMENDED. 3590 02:30:58,960 --> 02:31:02,800 THANK YOU. 3591 02:31:02,800 --> 02:31:03,680 >> OKAY, THANK YOU. 3592 02:31:03,680 --> 02:31:09,080 >> JUST A QUICK QUESTION. 3593 02:31:09,080 --> 02:31:11,400 WITH-- RUBEN HARRIS, U.T. 3594 02:31:11,400 --> 02:31:12,800 HEALTH, SAN ANTONIO. 3595 02:31:12,800 --> 02:31:14,440 CONTROLS FOR THIS EXPERIMENT, IF 3596 02:31:14,440 --> 02:31:16,080 YOU'VE GOT A SLOW RELEASE 3597 02:31:16,080 --> 02:31:18,160 STRATEGY WHERE YOU'VE GOT LAYER 3598 02:31:18,160 --> 02:31:19,920 UPON LAYER LIKE A JAWBREAKER, 3599 02:31:19,920 --> 02:31:21,240 HOW DO YOU CONTROL FOR THAT? 3600 02:31:21,240 --> 02:31:22,960 YOU CAN'T JUST HAVE A SIMPLE 3601 02:31:22,960 --> 02:31:24,200 PLACEBO, RIGHT? 3602 02:31:24,200 --> 02:31:26,120 BECAUSE IT'S PERSISTING IN THE 3603 02:31:26,120 --> 02:31:26,920 SYSTEM LONGER. 3604 02:31:26,920 --> 02:31:31,000 SO WHAT ARE THE CONTROLS THE 3605 02:31:31,000 --> 02:31:31,600 GROUPS ARE PROPOSING? 3606 02:31:31,600 --> 02:31:35,360 >> THIS IS WHERE YOU THINK ABOUT 3607 02:31:35,360 --> 02:31:36,360 CLINICAL TRIAL. 3608 02:31:36,360 --> 02:31:40,600 I DON'T THINK WE'RE THERE YET. 3609 02:31:40,600 --> 02:31:43,320 SO WE'RE STILL BASIC 3610 02:31:43,320 --> 02:31:44,440 PRE-CLINICAL PHASES HERE SO 3611 02:31:44,440 --> 02:31:46,520 WE'RE NOT -- IT'S NOT ABOUT 3612 02:31:46,520 --> 02:31:47,080 CLINICAL TRIALS. 3613 02:31:47,080 --> 02:31:52,760 I HAVE TO THINK ABOUT IT, YOU 3614 02:31:52,760 --> 02:31:54,640 CAN DO PLACEBO, I DON'T KNOW. 3615 02:31:54,640 --> 02:31:57,920 YOU CAN COMPARE MAYBE TO 3616 02:31:57,920 --> 02:32:03,280 INJECTION AND PRIME BOOST, BUT, 3617 02:32:03,280 --> 02:32:03,480 YEAH. 3618 02:32:03,480 --> 02:32:05,040 >> MAYBE, BECAUSE IT'S NOT THE 3619 02:32:05,040 --> 02:32:13,360 SAME AS LIKE A SALINE OR A MOCK 3620 02:32:13,360 --> 02:32:14,600 OR EMPTY CONTROL. 3621 02:32:14,600 --> 02:32:19,600 >> EMPTY MICROPARTICLES, FOR 3622 02:32:19,600 --> 02:32:20,120 EXAMPLE. 3623 02:32:20,120 --> 02:32:23,400 THEY DO LIKE THE DEVICE BUT 3624 02:32:23,400 --> 02:32:25,760 WITHOUT THE ANTIGEN OR ADJUVANT. 3625 02:32:25,760 --> 02:32:26,480 >> GREAT. 3626 02:32:26,480 --> 02:32:26,720 THANKS. 3627 02:32:26,720 --> 02:32:29,000 >> YES. 3628 02:32:29,000 --> 02:32:31,840 3629 02:32:31,840 --> 02:32:32,960 >> A QUESTION? 3630 02:32:32,960 --> 02:32:33,440 >> NOPE. 3631 02:32:33,440 --> 02:32:35,480 >> NOTHING ONLINE. 3632 02:32:35,480 --> 02:32:39,400 >> THANKS VERY MUCH. 3633 02:32:39,400 --> 02:32:39,800 PLEASE VOTE. 3634 02:32:39,800 --> 02:32:44,160 AND NOW I'D LIKE TO INTRODUCE 3635 02:32:44,160 --> 02:32:47,400 JOYELLE DOMINIQUE FROM OFFICE OF 3636 02:32:47,400 --> 02:32:51,040 GLOBAL RESEARCH, AND WHILE THIS 3637 02:32:51,040 --> 02:32:53,520 IS THE LAST PRESENTATION, IT 3638 02:32:53,520 --> 02:32:54,480 CONTAINS THREE DIFFERENT 3639 02:32:54,480 --> 02:32:55,240 INITIATIVES. 3640 02:32:55,240 --> 02:32:57,320 SO WHEN YOU'RE VOTING HERE, YOU 3641 02:32:57,320 --> 02:32:59,000 HAVE TO DO ALL THREE. 3642 02:32:59,000 --> 02:32:59,280 OVER TO YOU. 3643 02:32:59,280 --> 02:33:01,160 >> THANK YOU SO MUCH. 3644 02:33:01,160 --> 02:33:02,240 GOOD AFTERNOON. 3645 02:33:02,240 --> 02:33:04,440 I'M THE DIRECTOR OF THE NIAID 3646 02:33:04,440 --> 02:33:05,760 OFFICE OF GLOBAL RESEARCH, AND 3647 02:33:05,760 --> 02:33:07,720 THANK YOU TO ARAC AND DIVISION 3648 02:33:07,720 --> 02:33:11,360 OF AIDS FOR ALLOWING ME TO 3649 02:33:11,360 --> 02:33:13,560 PRESENT THESE CONCEPTS FOR 3650 02:33:13,560 --> 02:33:13,880 REVIEW. 3651 02:33:13,880 --> 02:33:17,720 I WANTED TO START BY MENTIONING 3652 02:33:17,720 --> 02:33:19,400 I DON'T THINK THIS AUDIENCE 3653 02:33:19,400 --> 02:33:22,000 WOULD HESITATE WHEN I SAY 3654 02:33:22,000 --> 02:33:22,840 INTERNATIONAL COLLABORATION IS 3655 02:33:22,840 --> 02:33:24,400 IMPORTANT, I THINK THERE ARE 3656 02:33:24,400 --> 02:33:26,240 MANY REASONS THAT IS THE CASE 3657 02:33:26,240 --> 02:33:30,640 BUT DID WANT TO MENTION WHY WE 3658 02:33:30,640 --> 02:33:31,640 DO BILATERAL PROGRAMS, AN 3659 02:33:31,640 --> 02:33:33,680 EXTENSION OF HOW WE FUND 3660 02:33:33,680 --> 02:33:35,080 INTERNATIONAL RESEARCH. 3661 02:33:35,080 --> 02:33:37,920 REAL OPPORTUNITY HERE IS BOTH 3662 02:33:37,920 --> 02:33:39,040 FACILITATING AND FOSTERING 3663 02:33:39,040 --> 02:33:40,680 COLLABORATION BETWEEN U.S. AND 3664 02:33:40,680 --> 02:33:48,920 FOREIGN SCIENTISTS BUT ALSO 3665 02:33:48,920 --> 02:33:49,560 STRENGTHENING 3666 02:33:49,560 --> 02:33:50,040 GOVERNMENT-TO-GOVERNMENT 3667 02:33:50,040 --> 02:33:50,600 RELATIONSHIPS, ESPECIALLY 3668 02:33:50,600 --> 02:33:53,280 COMPANIES INVESTING IN THEIR OWN 3669 02:33:53,280 --> 02:33:54,160 BIOMEDICAL RESEARCH. 3670 02:33:54,160 --> 02:33:55,240 OBJECTIVES OF BILATERAL 3671 02:33:55,240 --> 02:33:57,320 PROGRAMS, SPEAKING TODAY ABOUT 3672 02:33:57,320 --> 02:33:59,960 BRAZIL AND SOUTH AFRICA, TO 3673 02:33:59,960 --> 02:34:01,040 INCREASE COLLABORATIVE RESEARCH 3674 02:34:01,040 --> 02:34:02,680 AND TRAINING OPPORTUNITIES 3675 02:34:02,680 --> 02:34:03,560 BETWEEN U.S. AND THESE 3676 02:34:03,560 --> 02:34:08,280 SCIENTISTS . 3677 02:34:08,280 --> 02:34:12,520 TO INITIATE OR STRENGTHEN 3678 02:34:12,520 --> 02:34:13,840 LONG-TERM COLLABORATION OVER A 3679 02:34:13,840 --> 02:34:15,720 WIDE RANGE, TO STRENGTHEN 3680 02:34:15,720 --> 02:34:16,960 RELATIONSHIPS BETWEEN RESEARCH 3681 02:34:16,960 --> 02:34:18,400 FUNDING AGENCIES. 3682 02:34:18,400 --> 02:34:20,960 AND TO STRENGTHEN RESEARCH 3683 02:34:20,960 --> 02:34:22,280 MANAGEMENT CAPACITY OF 3684 02:34:22,280 --> 02:34:23,040 INVESTIGATORS IN THESE COUNTRIES 3685 02:34:23,040 --> 02:34:26,680 SO THEY CAN BE COMPETITIVE GOING 3686 02:34:26,680 --> 02:34:28,600 FORWARD FOR NIH COLLABORATION. 3687 02:34:28,600 --> 02:34:33,120 AND TO EXPAND FOCUS ON NIH AND 3688 02:34:33,120 --> 02:34:34,760 U.S. SCIENTIST-IDENTIFIED AREAS 3689 02:34:34,760 --> 02:34:35,960 OF RESEARCH PRIORITIES, THERE'S 3690 02:34:35,960 --> 02:34:38,040 AN OPPORTUNITY FOR US TO HELP 3691 02:34:38,040 --> 02:34:40,680 DEFINE WHAT IS THE AREAS OF 3692 02:34:40,680 --> 02:34:43,720 PRIORITY FOR THESE COLLABORATIVE 3693 02:34:43,720 --> 02:34:44,920 RESEARCH PROGRAMS. 3694 02:34:44,920 --> 02:34:47,520 WE DO MANAGE THESE PROGRAMS ON 3695 02:34:47,520 --> 02:34:48,640 BEHALF OF NIH, SO THERE ARE 3696 02:34:48,640 --> 02:34:50,400 MULTIPLE I.C.s THAT 3697 02:34:50,400 --> 02:34:52,560 PARTICIPATE IN THIS INITIATIVE 3698 02:34:52,560 --> 02:34:54,240 AS WELL AS THE FUNDING 3699 02:34:54,240 --> 02:34:57,320 ORGANIZATIONS IN THE OTHER 3700 02:34:57,320 --> 02:34:57,600 COUNTRIES. 3701 02:34:57,600 --> 02:35:01,560 SO I'LL START WITH U.S.-SOUTH 3702 02:35:01,560 --> 02:35:01,920 AFRICA. 3703 02:35:01,920 --> 02:35:04,440 THESE, ALL OF THESE ARE 3704 02:35:04,440 --> 02:35:06,040 REISSUES, THIS WOULD BE THE 3705 02:35:06,040 --> 02:35:08,880 FIRED PHASE OF OUR U.S.-SOUTH 3706 02:35:08,880 --> 02:35:10,200 AFRICA PROGRAM. 3707 02:35:10,200 --> 02:35:16,680 IT IS AN RFA, R01 FIVE-YEAR 3708 02:35:16,680 --> 02:35:18,760 PROGRAM, NIAID COMMITMENT FIRST 3709 02:35:18,760 --> 02:35:21,120 YEAR $1.25 MILLION, FIVE-YEAR 3710 02:35:21,120 --> 02:35:23,560 AWARDS WITH 6 TO 8 NIAID AWARDS. 3711 02:35:23,560 --> 02:35:25,080 WE'RE WORKING, THIS IS JUST OUR 3712 02:35:25,080 --> 02:35:25,960 NIAID COMMITMENT. 3713 02:35:25,960 --> 02:35:29,560 WE'RE WORKING ON BEHALF OF ALL 3714 02:35:29,560 --> 02:35:31,200 THE INSTITUTES THAT PARTNER IN 3715 02:35:31,200 --> 02:35:32,640 THESE INITIATIVES TO SUPPORT A 3716 02:35:32,640 --> 02:35:37,360 WIDE RANGE OF RESEARCH AREAS. 3717 02:35:37,360 --> 02:35:39,640 THESE ARE NIAID-FOCUSED RESEARCH 3718 02:35:39,640 --> 02:35:41,200 AREAS, ONLY NIAID, THAT I'M 3719 02:35:41,200 --> 02:35:42,600 PRESENTING TODAY. 3720 02:35:42,600 --> 02:35:44,480 WE'RE WORKING ACROSS NIH TO 3721 02:35:44,480 --> 02:35:45,800 GATHER INTEREST FROM THE 3722 02:35:45,800 --> 02:35:46,760 DIFFERENT INSTITUTES AND 3723 02:35:46,760 --> 02:35:47,240 CENTERS. 3724 02:35:47,240 --> 02:35:49,480 BUT YOU CAN SEE HERE EVEN ACROSS 3725 02:35:49,480 --> 02:35:51,800 NIAID WE INCLUDE ALL OF OUR 3726 02:35:51,800 --> 02:35:53,920 DIVISION AREAS OF INTEREST, AND 3727 02:35:53,920 --> 02:35:57,520 WE WOULD PROPOSE AGAIN TO MOVE 3728 02:35:57,520 --> 02:36:01,360 FORWARD ACROSS AS NIAID 3729 02:36:01,360 --> 02:36:04,080 PARTICIPATING IN THESE 3730 02:36:04,080 --> 02:36:04,400 INITIATIVES. 3731 02:36:04,400 --> 02:36:08,120 THE IMPORTANCE IN SOUTH AFRICA 3732 02:36:08,120 --> 02:36:10,200 IS SOUTH AFRICA HAS SKILLED 3733 02:36:10,200 --> 02:36:12,480 BIOMEDICAL SCIENTISTS INVESTING 3734 02:36:12,480 --> 02:36:13,800 IN BIOMEDICAL RESEARCH CAPACITY. 3735 02:36:13,800 --> 02:36:16,000 THEY ARE WORKING ON INNOVATIVE 3736 02:36:16,000 --> 02:36:19,160 VACCINE STRATEGIES AND OTHER 3737 02:36:19,160 --> 02:36:19,440 BIOLOGICS. 3738 02:36:19,440 --> 02:36:22,040 AND THIS WOULD ALLOW US TO HAVE 3739 02:36:22,040 --> 02:36:26,200 THE COMPLEMENTARY FUNDING OF A 3740 02:36:26,200 --> 02:36:26,840 FOREIGN BIOMEDICAL RESEARCH 3741 02:36:26,840 --> 02:36:27,720 ORGANIZATION. 3742 02:36:27,720 --> 02:36:29,480 THIS WOULD BE THE THIRD PHASE OF 3743 02:36:29,480 --> 02:36:31,760 THIS PROGRAM SO THE FIRST TWO 3744 02:36:31,760 --> 02:36:32,960 PHASES ARE JUST HIGHLIGHTED 3745 02:36:32,960 --> 02:36:36,600 HERE, AND I WOULD JUST NOTE THAT 3746 02:36:36,600 --> 02:36:38,360 THESE ARE PROGRAMS WHERE THE 3747 02:36:38,360 --> 02:36:40,120 FOREIGN FUNDING AGENCY FUNDS 3748 02:36:40,120 --> 02:36:42,400 THEIR SCIENTISTS AND NIH FUNDS 3749 02:36:42,400 --> 02:36:44,680 THE U.S. SCIENTISTS, IN THIS 3750 02:36:44,680 --> 02:36:47,560 PARTICULAR CASE SOUTH AFRICAN 3751 02:36:47,560 --> 02:36:49,960 MEDICAL RESEARCH COUNCIL GIVERS 3752 02:36:49,960 --> 02:36:51,080 NIAID THE FUNDING, NIAID ISSUES 3753 02:36:51,080 --> 02:36:53,680 OF THE AWARD BUT WE STRICTLY 3754 02:36:53,680 --> 02:36:57,520 MANAGE FUNDING SO THE 3755 02:36:57,520 --> 02:36:58,720 CONTRIBUTIONS OF SOUTH AFRICAN 3756 02:36:58,720 --> 02:37:03,120 GO TO THE SOUTH AFRICAN PI. 3757 02:37:03,120 --> 02:37:06,600 YOU CAN SEE THAT WE'VE HAD A 3758 02:37:06,600 --> 02:37:07,920 COUPLE ITERATIONS HERE BUT 3759 02:37:07,920 --> 02:37:12,320 OVERALL WE PLAN TO MOVE FORWARD 3760 02:37:12,320 --> 02:37:16,120 WITH THE R01 COMPONENT FOR THE 3761 02:37:16,120 --> 02:37:16,560 THIRD PHASE. 3762 02:37:16,560 --> 02:37:18,600 THIS HAS BEEN A PRODUCTIVE 3763 02:37:18,600 --> 02:37:20,920 PROGRAM, YOU CAN SEE BETWEEN THE 3764 02:37:20,920 --> 02:37:24,200 TWO PHASES HAVE BEEN 54 AWARDS, 3765 02:37:24,200 --> 02:37:26,400 AND THAT ALSO DOESN'T INCLUDE 3766 02:37:26,400 --> 02:37:27,560 SOME OF THE INITIATIVES THAT 3767 02:37:27,560 --> 02:37:30,000 WE'VE BEEN ABLE TO DO WITH THE 3768 02:37:30,000 --> 02:37:31,400 SOUTH AFRICAN MEDICAL RESEARCH 3769 02:37:31,400 --> 02:37:35,920 COUNCIL AS NIH AND FOREIGN 3770 02:37:35,920 --> 02:37:39,160 FUNDER TO PROMOTE RESEARCH AND 3771 02:37:39,160 --> 02:37:40,520 GOOD RESEARCH PRACTICES, LIKE 3772 02:37:40,520 --> 02:37:41,920 WRITING APPLICATIONS, ABLE TO 3773 02:37:41,920 --> 02:37:43,800 PARTNER WITH SOUTH AFRICAN MRC 3774 02:37:43,800 --> 02:37:46,520 TO HELP THEM SUPPORT THEIR 3775 02:37:46,520 --> 02:37:47,480 RESEARCHERS AND I THINK THIS 3776 02:37:47,480 --> 02:37:49,640 JUST TAKES ADVANTAGE OF THE 3777 02:37:49,640 --> 02:37:51,000 COLLABORATION WHERE WE CAN 3778 02:37:51,000 --> 02:37:54,160 REALLY ENHANCE WHAT WE'RE DOING 3779 02:37:54,160 --> 02:37:57,120 AND STRIVE TO CREATE VERY 3780 02:37:57,120 --> 02:37:59,680 WELL-POSITIONED TEAMS TO BE 3781 02:37:59,680 --> 02:38:03,040 COMPETITIVE FOR RESEARCH. 3782 02:38:03,040 --> 02:38:04,680 A FEW OF THE PUBLICATIONS YOU 3783 02:38:04,680 --> 02:38:10,800 SAW IN THE LAST SLIDE, AT THE 3784 02:38:10,800 --> 02:38:11,760 MOMENT ALMOST 300 PUBLICATIONS 3785 02:38:11,760 --> 02:38:14,320 FROM THE FIRST TWO PHASES OF 3786 02:38:14,320 --> 02:38:15,160 THIS PROGRAM. 3787 02:38:15,160 --> 02:38:18,120 AND THAT IS THE SECOND PHASE IS 3788 02:38:18,120 --> 02:38:20,320 STILL ONGOING SO WE EXPECT THAT 3789 02:38:20,320 --> 02:38:21,760 WILL CONTINUE TO INCREASE. 3790 02:38:21,760 --> 02:38:23,400 AND JUST TO MENTION I DON'T HAVE 3791 02:38:23,400 --> 02:38:26,640 TIME TO GO INTO ALL OF THE 3792 02:38:26,640 --> 02:38:27,440 DIVERSE SCIENTIFIC ACHIEVEMENTS 3793 02:38:27,440 --> 02:38:34,680 TODAY BUT THERE HAVE BEEN A 3794 02:38:34,680 --> 02:38:38,480 NUMBER THROUGHOUT THE PROGRAM. 3795 02:38:38,480 --> 02:38:41,760 U.S.-BRAZIL PROGRAM, AGAIN 3796 02:38:41,760 --> 02:38:43,960 SIMILAR LOOKING, REISSUE, RFA, 3797 02:38:43,960 --> 02:38:46,960 R01, FIRST YEAR COMMITMENT FROM 3798 02:38:46,960 --> 02:38:51,080 NIAID WOULD BE $1.25 MILLION. 3799 02:38:51,080 --> 02:38:51,960 AGAIN, FIVE-YEAR PROGRAM, 3800 02:38:51,960 --> 02:38:54,880 ANTICIPATE 5 TO 6 NIAID AWARDS. 3801 02:38:54,880 --> 02:38:56,080 FUNDING PARTNERS IN BRAZIL 3802 02:38:56,080 --> 02:38:58,960 MINISTRY OF HEALTH AND MINISTRY 3803 02:38:58,960 --> 02:39:00,120 OF SCIENCE, TECHNOLOGY, 3804 02:39:00,120 --> 02:39:00,800 INNOVATION. 3805 02:39:00,800 --> 02:39:05,200 AGAIN, WE HAVE MULTIPLE I.C.s 3806 02:39:05,200 --> 02:39:06,160 PARTICIPATING IN THIS 3807 02:39:06,160 --> 02:39:07,880 INITIATIVE. 3808 02:39:07,880 --> 02:39:10,520 AGAIN, HERE I'M HIGHLIGHTING THE 3809 02:39:10,520 --> 02:39:11,640 PROPOSED NIAID RESEARCH FOCUS, 3810 02:39:11,640 --> 02:39:15,240 YOU CAN SEE IT GOES ACROSS ALL 3811 02:39:15,240 --> 02:39:18,440 AREAS OF NIAID RESEARCH 3812 02:39:18,440 --> 02:39:21,480 PRIORITY, AND THERE IS MUCH 3813 02:39:21,480 --> 02:39:23,360 INTEREST IN THIS INTERFACE WITH 3814 02:39:23,360 --> 02:39:23,600 BRAZIL. 3815 02:39:23,600 --> 02:39:27,280 YOU CAN SEE WE HAVE EVEN MORE 3816 02:39:27,280 --> 02:39:29,720 DIVERSITY HERE, AS WELL, FOR OUR 3817 02:39:29,720 --> 02:39:34,400 DIFFERENT PROGRAMS. 3818 02:39:34,400 --> 02:39:37,560 AGAIN, BRAZIL OFFERS 3819 02:39:37,560 --> 02:39:38,360 OPPORTUNITIES FOR OUTSTANDING 3820 02:39:38,360 --> 02:39:39,880 COLLABORATIVE RESEARCH, SPECIAL 3821 02:39:39,880 --> 02:39:40,880 LOY AREAS THAT ARE GROWING 3822 02:39:40,880 --> 02:39:43,840 IMPORTANCE TO THE UNITED STATES. 3823 02:39:43,840 --> 02:39:48,000 WE HAVE -- THERE ARE 3824 02:39:48,000 --> 02:39:49,720 AVAILABLE -- ESTABLISHED AND 3825 02:39:49,720 --> 02:39:51,400 WELL RESOURCED SCIENTISTS FUNDED 3826 02:39:51,400 --> 02:39:53,680 BY THESE MINISTRIES I MENTIONED. 3827 02:39:53,680 --> 02:39:56,000 AND I WOULD SAY I WANT TO 3828 02:39:56,000 --> 02:39:57,880 EXPLAIN THIS IS THE SECOND PHASE 3829 02:39:57,880 --> 02:40:01,040 OF THIS PROGRAM, YOU SEE PHASE 3830 02:40:01,040 --> 02:40:03,120 1A AND 1B, TYPICALLY WHEN WE 3831 02:40:03,120 --> 02:40:05,320 START A BILATERAL PROGRAM WE 3832 02:40:05,320 --> 02:40:06,200 START WITH ADMINISTRATIVE 3833 02:40:06,200 --> 02:40:06,960 SUPPLEMENTS SO THAT'S WHAT 3834 02:40:06,960 --> 02:40:08,600 HAPPENED WITH THIS PROGRAM AND 3835 02:40:08,600 --> 02:40:12,000 THEN WE DID ISSUE A FOUR-YEAR 3836 02:40:12,000 --> 02:40:13,240 R01, SO THIS OFFICIALLY WILL BE 3837 02:40:13,240 --> 02:40:19,760 THE SECOND PHASE OF THE 3838 02:40:19,760 --> 02:40:20,960 U.S.-BRAZIL PROGRAM. 3839 02:40:20,960 --> 02:40:24,000 AND DIFFERENT FROM THE SOUTH 3840 02:40:24,000 --> 02:40:26,960 AFRICA MEDICAL RESEARCH COUNCIL, 3841 02:40:26,960 --> 02:40:30,160 NIH FUNDS THE U.S. P.I. 3842 02:40:30,160 --> 02:40:31,680 DIRECTLY, BRAZILIAN AGENCIES 3843 02:40:31,680 --> 02:40:34,000 FUND BRAZILIAN P.I. DIRECTLY, SO 3844 02:40:34,000 --> 02:40:39,240 NO FUNDING IS EXCHANGED IN THIS 3845 02:40:39,240 --> 02:40:39,880 CASE. 3846 02:40:39,880 --> 02:40:41,440 AGAIN WE WANT TO FOSTER THESE 3847 02:40:41,440 --> 02:40:45,280 RELATIONSHIPS BETWEEN U.S. AND 3848 02:40:45,280 --> 02:40:46,480 BRAZILIAN SCIENTISTS, AND ALSO 3849 02:40:46,480 --> 02:40:49,760 TAKE ADVANTAGE OF WHAT IS AN 3850 02:40:49,760 --> 02:40:51,400 EXPANDING AND GROWING 3851 02:40:51,400 --> 02:40:53,800 OPPORTUNITY IN BRAZIL FOR 3852 02:40:53,800 --> 02:40:54,120 RESEARCH. 3853 02:40:54,120 --> 02:40:58,160 THERE IS NEW ADMINISTRATION IN 3854 02:40:58,160 --> 02:41:00,240 BRAZIL THAT IS VERY PRO SCIENCE 3855 02:41:00,240 --> 02:41:02,960 AND WE HAVE SOME OPPORTUNITIES 3856 02:41:02,960 --> 02:41:06,240 TO REALLY WORK WITH OUR 3857 02:41:06,240 --> 02:41:10,200 BRAZILIAN COUNTERPARTS TO FIND 3858 02:41:10,200 --> 02:41:13,160 THESE AREAS AND LEVERAGE OUR 3859 02:41:13,160 --> 02:41:14,640 MUTUAL INTEREST TO MOVE SCIENCE 3860 02:41:14,640 --> 02:41:15,320 FORWARD. 3861 02:41:15,320 --> 02:41:21,160 YOU CAN SEE HERE PHASE 1A WAS 19 3862 02:41:21,160 --> 02:41:23,320 SUPPLEMENTS, PHASE 1B ABLE TO 3863 02:41:23,320 --> 02:41:25,520 AWARD 12 AWARDS, AGAIN THESE ARE 3864 02:41:25,520 --> 02:41:27,600 STILL ONGOING AND WE'RE 3865 02:41:27,600 --> 02:41:30,240 CONTINUING TO LOOK AT THE 3866 02:41:30,240 --> 02:41:32,200 OPPORTUNITIES AND OUTCOMES OF 3867 02:41:32,200 --> 02:41:33,080 THESE INITIATIVES. 3868 02:41:33,080 --> 02:41:34,280 WE'LL ALSO HIGHLIGHT THOSE 3869 02:41:34,280 --> 02:41:36,960 SPECIFICALLY IN THE CASE OF 3870 02:41:36,960 --> 02:41:40,760 BRAZIL, OPENING OF GOVERNMENT TO 3871 02:41:40,760 --> 02:41:42,280 GOVERNMENT RELATIONSHIPS, 3872 02:41:42,280 --> 02:41:43,920 FUNDING TOGETHER AT PARTNERS, 3873 02:41:43,920 --> 02:41:45,400 WAS REALLY LEVERAGED DURING THE 3874 02:41:45,400 --> 02:41:49,240 ZIKA OUTBREAK AND I THINK THAT 3875 02:41:49,240 --> 02:41:50,600 GOES FOR ANY OUTBREAK, 3876 02:41:50,600 --> 02:41:52,440 RELATIONSHIPS THAT ARE 3877 02:41:52,440 --> 02:41:53,200 ESTABLISHED DURING THESE 3878 02:41:53,200 --> 02:41:54,280 PARTNERSHIPS REALLY CONTRIBUTE 3879 02:41:54,280 --> 02:41:56,280 TO WHAT WE CAN DO DURING 3880 02:41:56,280 --> 02:41:58,040 OUTBREAKS AND HOW WE CAN MOVE 3881 02:41:58,040 --> 02:41:59,520 SCIENCE FORWARD. 3882 02:41:59,520 --> 02:42:05,160 IT HELPS US TO PUT FORWARD AREAS 3883 02:42:05,160 --> 02:42:07,560 OF CHALLENGES WITH GLOBAL 3884 02:42:07,560 --> 02:42:08,760 RESEARCH, FOR EXAMPLE, SAMPLE 3885 02:42:08,760 --> 02:42:12,480 AND DATA SHARING AND BE ABLE TO 3886 02:42:12,480 --> 02:42:14,640 OPEN CONVERSATIONS ON A 3887 02:42:14,640 --> 02:42:17,440 PARTNER-TO-PARTNER LEVEL TO TRY 3888 02:42:17,440 --> 02:42:20,040 TO ENHANCE NOT ONLY THE 3889 02:42:20,040 --> 02:42:21,240 INDIVIDUAL PARTNERSHIPS BUT 3890 02:42:21,240 --> 02:42:25,840 REALLY THE GLOBAL PARTNERSHIP 3891 02:42:25,840 --> 02:42:27,360 BETWEEN OUR COUNTRIES. 3892 02:42:27,360 --> 02:42:28,320 TO HIGHLIGHT SITUATION CAN'T 3893 02:42:28,320 --> 02:42:30,080 PUBLICATIONS THAT CAME OUT OF 3894 02:42:30,080 --> 02:42:34,520 THIS U.S.-BRAZIL INITIATIVE. 3895 02:42:34,520 --> 02:42:40,400 I'D LIKE TO THANK DR. ABRAMS AND 3896 02:42:40,400 --> 02:42:41,720 DR. PETTIFOR FOR REVIEWING, 3897 02:42:41,720 --> 02:42:43,800 THERE WAS ENTHUSIASM FOR 3898 02:42:43,800 --> 02:42:45,200 CONTINUING PROGRAMS. 3899 02:42:45,200 --> 02:42:47,760 WE DISCUSSED CHALLENGES AS WELL 3900 02:42:47,760 --> 02:42:50,000 THAT GRANTEES IN SOUTH AFRICA 3901 02:42:50,000 --> 02:42:51,600 AND BRAZIL WOULD BENEFIT FROM 3902 02:42:51,600 --> 02:42:53,560 CONTINUING TO DEVELOP THEIR 3903 02:42:53,560 --> 02:42:55,400 CAPACITY TO MANAGE NIH RESEARCH 3904 02:42:55,400 --> 02:42:58,160 GRANTS AND WE SEE THAT WIDELY IN 3905 02:42:58,160 --> 02:43:00,120 SOME OF OUR FOREIGN RESEARCH 3906 02:43:00,120 --> 02:43:00,400 PARTNERS. 3907 02:43:00,400 --> 02:43:02,280 AND I THINK THIS IS AN 3908 02:43:02,280 --> 02:43:03,520 OPPORTUNITY TO HELP WITH THAT 3909 02:43:03,520 --> 02:43:08,760 AND AS I MENTIONED WE HAVE A LOT 3910 02:43:08,760 --> 02:43:10,560 OF PARTNER PROGRAMS THAT WORK 3911 02:43:10,560 --> 02:43:14,760 UNDER THIS INITIATIVE THAT CAN 3912 02:43:14,760 --> 02:43:15,200 HELP FACILITATE THAT 3913 02:43:15,200 --> 02:43:16,960 DEVELOPMENT. 3914 02:43:16,960 --> 02:43:18,080 FOR EXAMPLE WITH THE FOGARTY 3915 02:43:18,080 --> 02:43:18,720 INTERNATIONAL CENTER. 3916 02:43:18,720 --> 02:43:21,800 THERE ARE A NUMBER OF CHALLENGES 3917 02:43:21,800 --> 02:43:24,080 WITH BILATERAL COLLABORATIVE 3918 02:43:24,080 --> 02:43:24,840 RESEARCH PARTNERSHIPS INCLUDING 3919 02:43:24,840 --> 02:43:25,400 ADMINISTRATION AND 3920 02:43:25,400 --> 02:43:27,680 ADMINISTRATIVE AND FINANCIAL AN 3921 02:43:27,680 --> 02:43:31,640 WE DISCUSSED SOME OF THIS, 3922 02:43:31,640 --> 02:43:34,480 RESEARCH IS EXPENSIVE AND SOME 3923 02:43:34,480 --> 02:43:35,480 OF THESE COUNTRIES, AND ALSO 3924 02:43:35,480 --> 02:43:37,000 THERE IS NOT ALWAYS THE SAME 3925 02:43:37,000 --> 02:43:39,320 TYPE OF SUPPORT THAT A U.S. 3926 02:43:39,320 --> 02:43:40,280 INSTITUTION MIGHT PROVIDE A 3927 02:43:40,280 --> 02:43:41,920 RESEARCHER SO THAT CAN BE A 3928 02:43:41,920 --> 02:43:46,760 CHALLENGE TO THE PARTNERSHIP. 3929 02:43:46,760 --> 02:43:48,040 FINDING WAYS AGAIN TO LEVERAGE 3930 02:43:48,040 --> 02:43:49,360 THE RELATIONSHIP AND ENCOURAGING 3931 02:43:49,360 --> 02:43:51,560 FUNDING PARTNERS TO PROVIDE SOME 3932 02:43:51,560 --> 02:43:53,440 SUPPORT TO DEVELOP OVERALL 3933 02:43:53,440 --> 02:43:54,280 COMPREHENSIVE CAPACITY I THINK 3934 02:43:54,280 --> 02:43:59,080 IS AN ADVANTAGE OF THIS PROGRAM. 3935 02:43:59,080 --> 02:44:00,640 AND THEN THEY ASKED FOR A LITTLE 3936 02:44:00,640 --> 02:44:02,400 BIT MORE OF A SUMMARY OF THE 3937 02:44:02,400 --> 02:44:03,680 PREVIOUS PHASES OF THE PROGRAM 3938 02:44:03,680 --> 02:44:06,000 WHICH I HOPE I PROVIDED TODAY. 3939 02:44:06,000 --> 02:44:09,400 BUT I WOULD BE HAPPY TO TAKE ANY 3940 02:44:09,400 --> 02:44:12,360 ADDITIONAL QUESTIONS AND JUST TO 3941 02:44:12,360 --> 02:44:14,440 HIGHLIGHT AGAIN THE TWO PROGRAMS 3942 02:44:14,440 --> 02:44:16,200 BUT, AGAIN, THREE CONCEPTS SO 3943 02:44:16,200 --> 02:44:18,960 SOUTH AFRICA HAS TWO CONCEPTS 3944 02:44:18,960 --> 02:44:21,160 BECAUSE WE HAVE AN HIV SPECIFIC 3945 02:44:21,160 --> 02:44:25,000 NOFO AND WE WOULD HAVE A NON-HIV 3946 02:44:25,000 --> 02:44:26,800 SPECIFIC NOFO, THOSE ARE TWO 3947 02:44:26,800 --> 02:44:28,200 CONCEPTS, AND THE THIRD WOULD BE 3948 02:44:28,200 --> 02:44:28,600 FOR BRAZIL. 3949 02:44:28,600 --> 02:44:30,160 THANK YOU VERY MUCH FOR ALLOWING 3950 02:44:30,160 --> 02:44:31,560 ME TO PRESENT THESE AND I'M 3951 02:44:31,560 --> 02:44:38,240 HAPPY TO TAKE ANY QUESTIONS. 3952 02:44:38,240 --> 02:44:39,440 >> THANK YOU. 3953 02:44:39,440 --> 02:44:42,520 MONICA, YOU HAVE A QUESTION? 3954 02:44:42,520 --> 02:44:44,920 >> YEAH, THESE ARE SUCH GREAT 3955 02:44:44,920 --> 02:44:45,200 INITIATIVES. 3956 02:44:45,200 --> 02:44:46,520 MY ONLY QUESTION WAS ON THE 3957 02:44:46,520 --> 02:44:48,080 SOUTH AFRICA ONE WAS ABOUT 3958 02:44:48,080 --> 02:44:50,120 MALARIA THAT I DIDN'T SEE ON THE 3959 02:44:50,120 --> 02:44:51,920 LIST, MAYBE THAT WASN'T 3960 02:44:51,920 --> 02:44:54,640 COMPREHENSIVE BECAUSE I SAW SO 3961 02:44:54,640 --> 02:44:55,960 MANY COMPREHENSIVE, DENGUE AND 3962 02:44:55,960 --> 02:44:58,800 THE IDEA OF ARBOVIRUSES IN 3963 02:44:58,800 --> 02:45:01,320 BRAZIL, AND THEN ALSO CHOLERA 3964 02:45:01,320 --> 02:45:03,400 OUTBREAKS OR OTHER OUTBREAKS 3965 02:45:03,400 --> 02:45:06,240 THAT ARE KIND OF THERE AND COME 3966 02:45:06,240 --> 02:45:12,600 BACK, IS IT COMPREHENSIVE, YOUR 3967 02:45:12,600 --> 02:45:12,800 LIST? 3968 02:45:12,800 --> 02:45:15,480 >> WE JUST HAD A MEETING WITH 3969 02:45:15,480 --> 02:45:16,560 OUR BRAZILIAN COUNTERPARTS THIS 3970 02:45:16,560 --> 02:45:18,640 MORNING WHERE WE SHARED ABOUT 3971 02:45:18,640 --> 02:45:21,040 THREE PAGES WORTH OF POTENTIAL 3972 02:45:21,040 --> 02:45:22,640 AREAS FOR COLLABORATION. 3973 02:45:22,640 --> 02:45:24,440 SO, I THINK THERE IS STILL A LOT 3974 02:45:24,440 --> 02:45:26,320 OF TIME FOR DISCUSSION AND 3975 02:45:26,320 --> 02:45:27,840 REFINEMENT OF THE AREAS OF 3976 02:45:27,840 --> 02:45:29,080 PRIORITY, AND SOME OF IT HAS 3977 02:45:29,080 --> 02:45:33,000 JUST BEEN IN THE PRIOR FOCUS OF 3978 02:45:33,000 --> 02:45:35,160 THE NOFO BUT WE'RE ALWAYS OPEN 3979 02:45:35,160 --> 02:45:37,000 TO DISCUSSING IMPORTANT AREAS OF 3980 02:45:37,000 --> 02:45:38,000 COLLABORATION ESPECIALLY FOR THE 3981 02:45:38,000 --> 02:45:39,640 U.S. SCIENTISTS THAT WANT TO 3982 02:45:39,640 --> 02:45:40,680 ENGAGE IN THESE COUNTRIES SO 3983 02:45:40,680 --> 02:45:43,240 I'LL TAKE THAT BACK TO OUR 3984 02:45:43,240 --> 02:45:45,320 DEVELOPING COMMITTEE AND MAKE 3985 02:45:45,320 --> 02:45:50,920 SURE THOSE ARE CONSIDERED. 3986 02:45:50,920 --> 02:45:52,320 >> OTHER QUESTIONS? 3987 02:45:52,320 --> 02:45:54,080 >> I ASSUMED SCIENTISTS FROM 3988 02:45:54,080 --> 02:45:55,600 THESE AREAS THAT WE'RE 3989 02:45:55,600 --> 02:45:56,800 COLLABORATING WITH, BRAZIL AND 3990 02:45:56,800 --> 02:46:00,080 SOUTH AFRICA, ARE INVOLVED WITH 3991 02:46:00,080 --> 02:46:02,800 THAT, THOSE LISTS OF RESEARCH 3992 02:46:02,800 --> 02:46:03,400 FOCUS AREAS. 3993 02:46:03,400 --> 02:46:03,760 >> ABSOLUTELY. 3994 02:46:03,760 --> 02:46:04,920 >> INTENTIONAL DELIBERATE 3995 02:46:04,920 --> 02:46:05,600 MEANINGFUL WAY. 3996 02:46:05,600 --> 02:46:07,000 >> ABSOLUTELY. 3997 02:46:07,000 --> 02:46:08,400 THESE ARE DEVELOPED, ONE OF THE 3998 02:46:08,400 --> 02:46:09,520 REASONS THESE PROGRAMS TAKE A 3999 02:46:09,520 --> 02:46:11,440 LONG TIME TO DEVELOP AND A LONG 4000 02:46:11,440 --> 02:46:12,440 TIME TO IMPLEMENT IS BECAUSE 4001 02:46:12,440 --> 02:46:15,640 THERE ARE MANY, MANY LEVELS OF 4002 02:46:15,640 --> 02:46:16,680 NEGOTIATIONS, WE'RE WORKING 4003 02:46:16,680 --> 02:46:19,000 ACROSS NIH AS WELL AS WITH 4004 02:46:19,000 --> 02:46:20,080 FUNDING AGENCIES IN DIFFERENT 4005 02:46:20,080 --> 02:46:22,440 COUNTRIES THAT ARE GOING THROUGH 4006 02:46:22,440 --> 02:46:24,040 THEIR DELIBERATION PROCESSES AND 4007 02:46:24,040 --> 02:46:25,480 THEIR STRATEGIES, SO IT TAKES 4008 02:46:25,480 --> 02:46:26,320 MULTIPLE MEETINGS TO COME 4009 02:46:26,320 --> 02:46:28,440 TOGETHER AND MAKE SURE WE'RE ALL 4010 02:46:28,440 --> 02:46:30,280 ALIGNED AND BECAUSE WE DO WANT 4011 02:46:30,280 --> 02:46:35,400 TO MAKE SURE THERE'S MUTUAL 4012 02:46:35,400 --> 02:46:37,160 INTEREST, WE DON'T WANT TO ONE 4013 02:46:37,160 --> 02:46:38,840 SIDE INTERESTED AND WE PUT IT 4014 02:46:38,840 --> 02:46:39,800 FORWARD, THERE'S A LOT OF 4015 02:46:39,800 --> 02:46:42,320 DISCUSSION AND INPUT FROM ALL 4016 02:46:42,320 --> 02:46:46,840 THE STAKEHOLDERS THAT ARE 4017 02:46:46,840 --> 02:46:47,120 INVOLVED. 4018 02:46:47,120 --> 02:46:47,640 >> THANK YOU. 4019 02:46:47,640 --> 02:46:50,040 >> THIS IS REALLY COOL. 4020 02:46:50,040 --> 02:46:52,680 I THINK VERY MUTUALLY 4021 02:46:52,680 --> 02:46:54,480 BENEFICIAL, FROM OUR POINT OF 4022 02:46:54,480 --> 02:46:55,440 VIEW ALLOWS RESEARCH THAT WOULD 4023 02:46:55,440 --> 02:46:59,920 BE DIFFICULT TO DO WITHOUT THESE 4024 02:46:59,920 --> 02:47:00,240 PARTNERSHIPS. 4025 02:47:00,240 --> 02:47:02,000 MY QUESTION, BRAZIL AND SOUTH 4026 02:47:02,000 --> 02:47:03,840 AFRICA, ARE THOSE THE ONE WE'RE 4027 02:47:03,840 --> 02:47:05,280 SEEING TODAY OR DO THEY EXIST 4028 02:47:05,280 --> 02:47:06,560 FOR MULTIPLE COUNTRIES AROUND 4029 02:47:06,560 --> 02:47:06,880 THE WORLD? 4030 02:47:06,880 --> 02:47:10,160 >> THE OTHER COUNTRY WE HAVE 4031 02:47:10,160 --> 02:47:11,080 PARTNERED WITH, BILATERAL 4032 02:47:11,080 --> 02:47:12,720 PROGRAM, THESE OFFICIAL NIH 4033 02:47:12,720 --> 02:47:13,720 MECHANISMS, WAS CHINA. 4034 02:47:13,720 --> 02:47:17,360 THAT ONE IS CURRENTLY ON HOLD. 4035 02:47:17,360 --> 02:47:19,000 BUT WE'RE HOPING THAT EITHER 4036 02:47:19,000 --> 02:47:20,720 THAT ONE OR POTENTIALLY OTHER 4037 02:47:20,720 --> 02:47:22,160 COUNTRIES MIGHT BE SELECTED. 4038 02:47:22,160 --> 02:47:23,120 THESE ARE SMALL PROGRAMS, WE 4039 02:47:23,120 --> 02:47:27,400 HAVE A SMALL AMOUNT OF FUNDED 4040 02:47:27,400 --> 02:47:28,400 DEDICATED TO BILATERAL PROGRAMS, 4041 02:47:28,400 --> 02:47:31,120 WE TRY TO THINK ABOUT HOW WE 4042 02:47:31,120 --> 02:47:32,400 ENGAGE AND WHO WE ENGAGEW MAKE 4043 02:47:32,400 --> 02:47:34,840 SURE THEY HAVE FUNDING TO BRING 4044 02:47:34,840 --> 02:47:36,280 TO THE TABLE, IT'S IMPORTANT 4045 02:47:36,280 --> 02:47:42,360 THEY ARE INVESTING IN BIOMEDICAL 4046 02:47:42,360 --> 02:47:43,560 RESEARCH CAPACITY, SO THERE IS 4047 02:47:43,560 --> 02:47:46,560 INTERFACE MY OFFICE DOES WITH 4048 02:47:46,560 --> 02:47:47,840 FOREIGN COUNTERPARTS IN MANY 4049 02:47:47,840 --> 02:47:49,600 COUNTRIES BUT THESE ARE THE MOST 4050 02:47:49,600 --> 02:47:54,840 FORMAL PROGRAMS THAT WE HAVE 4051 02:47:54,840 --> 02:47:55,120 THUS FAR. 4052 02:47:55,120 --> 02:47:55,440 >> HI. 4053 02:47:55,440 --> 02:47:56,480 THANKS SO MUCH. 4054 02:47:56,480 --> 02:47:57,600 THAT WAS GREAT. 4055 02:47:57,600 --> 02:48:01,440 I KNOW YOU HAD IT UP THERE BUT 4056 02:48:01,440 --> 02:48:03,920 I'M GOING TO BE LIKE A BROKEN 4057 02:48:03,920 --> 02:48:05,920 RECORD. 4058 02:48:05,920 --> 02:48:07,520 SO THE CAP IS 300,000 A YEAR 4059 02:48:07,520 --> 02:48:09,840 WHICH THESE ARE BOTH COUNTRIES 4060 02:48:09,840 --> 02:48:11,800 THAT ARE EXPENSIVE TO WORK IN, 4061 02:48:11,800 --> 02:48:16,360 AND SO WE HAVE ADVOCATED FOR 4062 02:48:16,360 --> 02:48:19,800 INCREASING TO THE U.S. 500K FOR 4063 02:48:19,800 --> 02:48:21,160 AN R01, I WORRY REVIEWERS IF 4064 02:48:21,160 --> 02:48:23,800 THEY ARE GOING TO EXPECT R01 4065 02:48:23,800 --> 02:48:25,640 LEVEL SCIENCE COMING OUT OF 4066 02:48:25,640 --> 02:48:27,040 THIS, IT'S JUST REALLY -- IT'S 4067 02:48:27,040 --> 02:48:30,000 HARD EVEN TO FIT WHEN YOU'RE 4068 02:48:30,000 --> 02:48:32,280 PUTTING IN 500,000 CAP FOR AN 4069 02:48:32,280 --> 02:48:35,040 R01 IN SOUTH AFRICA TO MAKE IT 4070 02:48:35,040 --> 02:48:35,200 FIT. 4071 02:48:35,200 --> 02:48:36,880 SO JUST KEEPING THAT IN MIND 4072 02:48:36,880 --> 02:48:40,840 THAT TO ME THIS IS LIKE R34, 4073 02:48:40,840 --> 02:48:43,920 VERY SMALL R01, IF WE'RE TALKING 4074 02:48:43,920 --> 02:48:44,760 300,000. 4075 02:48:44,760 --> 02:48:46,560 SO IT'S JUST CHALLENGING. 4076 02:48:46,560 --> 02:48:46,840 SO YEAH. 4077 02:48:46,840 --> 02:48:47,520 >> ABSOLUTELY. 4078 02:48:47,520 --> 02:48:49,600 I WILL SAY THAT WE HAVE ALREADY 4079 02:48:49,600 --> 02:48:51,800 HAD DISCUSSIONS WITH OUR FOREIGN 4080 02:48:51,800 --> 02:48:55,040 COUNTERPARTS ON WHAT WE CAN DO 4081 02:48:55,040 --> 02:48:56,680 TO DISCUSS HOW WE CAN TAKE THIS 4082 02:48:56,680 --> 02:48:58,640 FORWARD AND SEE IF MAYBE IT 4083 02:48:58,640 --> 02:49:01,200 WOULD BE WORTH WHILE TO HAVE A 4084 02:49:01,200 --> 02:49:04,040 BIGGER INVESTMENT IN A SMALLER 4085 02:49:04,040 --> 02:49:06,440 NUMBER OF PROGRAMS, THOSE 4086 02:49:06,440 --> 02:49:07,240 DISCUSSIONS ARE ALREADY 4087 02:49:07,240 --> 02:49:09,720 UNDERWAY. 4088 02:49:09,720 --> 02:49:12,520 >> IT SEEMS YOU SHOULD BE 4089 02:49:12,520 --> 02:49:14,200 CONGRATULATED FOR LEVERAGING ALL 4090 02:49:14,200 --> 02:49:16,280 OF THESE DIFFERENT PARTIES TO 4091 02:49:16,280 --> 02:49:20,560 GET SUCH FUNDING AS YOU HAD. 4092 02:49:20,560 --> 02:49:25,680 IF THERE ARE NO OTHER QUESTIONS, 4093 02:49:25,680 --> 02:49:28,640 I THANK YOU. 4094 02:49:28,640 --> 02:49:28,960 VOTE. 4095 02:49:28,960 --> 02:49:33,240 AND PLEASE VOTE, VOTE FOR ALL 4096 02:49:33,240 --> 02:49:33,560 THREE. 4097 02:49:33,560 --> 02:49:35,240 MAKE SURE YOU PUT YOUR VOTE IN 4098 02:49:35,240 --> 02:49:39,920 FOR ALL OF THE PRIOR ONES. 4099 02:49:39,920 --> 02:49:41,120 ONCE YOU'VE DONE THAT -- 4100 02:49:41,120 --> 02:49:43,520 >> WHILE YOU'RE IN THE PROCESS 4101 02:49:43,520 --> 02:49:47,920 OF FINISHING YOUR VOTING, I NEED 4102 02:49:47,920 --> 02:49:51,160 ONE LAST EN BLOC ACTION FROM THE 4103 02:49:51,160 --> 02:49:54,760 COMMITTEE TO ACCEPT ALL OF THE 4104 02:49:54,760 --> 02:49:56,200 RECOMMENDATIONS MADE BY THE 4105 02:49:56,200 --> 02:49:57,120 MEMBERS TODAY. 4106 02:49:57,120 --> 02:50:00,160 IF I COULD HAVE A MOTION TO 4107 02:50:00,160 --> 02:50:03,200 ACCEPT THE ENTIRE ARAC AGENDA. 4108 02:50:03,200 --> 02:50:06,560 AS FAR AS I CAN TELL EVERYTHING 4109 02:50:06,560 --> 02:50:07,080 WAS APPROVED. 4110 02:50:07,080 --> 02:50:09,120 IF I COULD HAVE A MOTION, A 4111 02:50:09,120 --> 02:50:13,280 SECOND, AND A SHOW OF HANDS. 4112 02:50:13,280 --> 02:50:14,280 THAT WOULD BE GREAT. 4113 02:50:14,280 --> 02:50:15,320 >> I MOVE. 4114 02:50:15,320 --> 02:50:16,240 >> SO APPROVED. 4115 02:50:16,240 --> 02:50:17,360 ALL IN FAVOR? 4116 02:50:17,360 --> 02:50:21,400 THANK YOU VERY MUCH. 4117 02:50:21,400 --> 02:50:22,720 ONCE WE'RE DONE VOTING, ELAINE 4118 02:50:22,720 --> 02:50:26,560 CAN OFFICIALLY CLOSE THE 4119 02:50:26,560 --> 02:50:26,800 MEETING. 4120 02:50:26,800 --> 02:50:29,520 >> OFFICIALLY CLOSE THE MEETING. 4121 02:50:29,520 --> 02:50:31,600 WE'LL SEE EVERYBODY IN JANUARY, 4122 02:50:31,600 --> 02:50:31,880 VIRTUALLY. 4123 02:50:31,880 --> 02:50:35,000 THANKS, EVERYONE, FOR YOUR TIME, 4124 02:50:35,000 --> 02:50:35,680 ATTENTION, AND GREAT 4125 02:50:35,680 --> 00:00:00,000 PRESENTATION.