1 00:00:05,120 --> 00:00:10,960 I'D LIKE TO WELCOME EVERYONE TO 2 00:00:10,960 --> 00:00:12,920 THE JANUARY MEETING OF THE 3 00:00:12,920 --> 00:00:15,600 DIVISION OF AIDS, AIDS RESEARCH 4 00:00:15,600 --> 00:00:18,800 ADVISORY COMMITTEE OR ARAC. 5 00:00:18,800 --> 00:00:24,920 I'M KEN BREEDBERG FROM MASS BRES 6 00:00:24,920 --> 00:00:25,680 GENERAL HOSPITAL. 7 00:00:25,680 --> 00:00:28,320 WE HAVE A BUSY AGENDA WHICH WE 8 00:00:28,320 --> 00:00:29,520 WILL STAY CLOSE TO THIS 9 00:00:29,520 --> 00:00:30,720 AFTERNOON. 10 00:00:30,720 --> 00:00:31,800 DR. DIEFFENBACH HAS ASKED ALL 11 00:00:31,800 --> 00:00:35,360 THE PROGRAM DIRECTORS TO TALK 12 00:00:35,360 --> 00:00:36,520 ABOUT SCIENCE FRAMING TALK FOR 13 00:00:36,520 --> 00:00:38,440 THEIR PROGRAMS AND ALSO TO THINK 14 00:00:38,440 --> 00:00:39,920 ABOUT SPECIFICALLY LESSONS 15 00:00:39,920 --> 00:00:41,440 LEARNED FROM THE PANDEMIC AND WE 16 00:00:41,440 --> 00:00:46,000 WILL HAVE TIME FOR DISCUSSION AT 17 00:00:46,000 --> 00:00:48,920 THE END, SO THAT WILL BE 18 00:00:48,920 --> 00:00:51,240 INFORMATIVE AND INTERESTING. 19 00:00:51,240 --> 00:00:52,680 I ENCOURAGE PEOPLE TO PUT 20 00:00:52,680 --> 00:00:53,760 COMMENTS INTO THE CHAT DURING 21 00:00:53,760 --> 00:00:55,040 THE PRESENTATIONS, AND HOPEFULLY 22 00:00:55,040 --> 00:00:57,160 WE WILL GET TO AS MANY OF THEM 23 00:00:57,160 --> 00:00:58,560 AS WE CAN DURING THE DISCUSSION. 24 00:00:58,560 --> 00:01:02,760 BEFORE WE GET STARTED, I'M 25 00:01:02,760 --> 00:01:04,080 WONDERING IF SOMEONE ON THE 26 00:01:04,080 --> 00:01:04,960 COMMITTEE COULD GIVE A MOTION -- 27 00:01:04,960 --> 00:01:07,160 I'D LIKE TO GIVE A MOTION TO 28 00:01:07,160 --> 00:01:08,040 APPROVE THE MINUTES FROM OUR 29 00:01:08,040 --> 00:01:12,320 SEPTEMBER MEETING. 30 00:01:12,320 --> 00:01:13,400 ANYONE -- OKAY, ANYONE SECOND 31 00:01:13,400 --> 00:01:14,400 THE MOTION? 32 00:01:14,400 --> 00:01:15,400 >>SECOND. 33 00:01:15,400 --> 00:01:17,280 >>THANK YOU. 34 00:01:17,280 --> 00:01:19,000 SO THERE IS A MOTION TO APPROVE 35 00:01:19,000 --> 00:01:20,880 THE MINUTES OF OUR SEPTEMBER 36 00:01:20,880 --> 00:01:23,280 MEETING. 37 00:01:23,280 --> 00:01:25,600 ANY DEBATE ABOUT THAT? 38 00:01:25,600 --> 00:01:28,240 ALL IN FAVOR OF APPROVING THE 39 00:01:28,240 --> 00:01:30,800 MINUTES? 40 00:01:30,800 --> 00:01:34,240 ANYONE OPPOSED? 41 00:01:34,240 --> 00:01:36,560 SEEING NO OPPOSITION THEN, THE 42 00:01:36,560 --> 00:01:38,080 MINUTES FROM THE SEPTEMBER 43 00:01:38,080 --> 00:01:39,240 MEETING ARE APPROVED. 44 00:01:39,240 --> 00:01:43,520 THANK YOU VERY MUCH. 45 00:01:43,520 --> 00:01:44,040 GREAT. 46 00:01:44,040 --> 00:01:46,480 BEFORE I TURN IT OVER TO 47 00:01:46,480 --> 00:01:48,480 DR. DIEFFENBACH, I WANTED TO 48 00:01:48,480 --> 00:01:51,480 JUST TAKE ONE MOMENT, THIS IS MY 49 00:01:51,480 --> 00:01:55,440 LAST MEETING AS CHAIR OF ARAC, 50 00:01:55,440 --> 00:01:57,320 AND ON BEHALF OF -- THERE ARE 51 00:01:57,320 --> 00:01:58,720 SEVERAL PEOPLE LEAVING THE 52 00:01:58,720 --> 00:01:59,280 COMMITTEE. 53 00:01:59,280 --> 00:02:03,960 DRS. AGARWAL, GUPTA, FRANK AND 54 00:02:03,960 --> 00:02:05,080 MYSELF. 55 00:02:05,080 --> 00:02:05,720 DR. DIEFFENBACH, I WANTED TO 56 00:02:05,720 --> 00:02:06,600 THANK YOU, WE WANT TO THANK YOU 57 00:02:06,600 --> 00:02:08,160 FOR THE OPPORTUNITY TO SERVE ON 58 00:02:08,160 --> 00:02:11,600 ARAC AND REALLY TO WORK WITH YOU 59 00:02:11,600 --> 00:02:12,720 AND EVERYONE IN THIS 60 00:02:12,720 --> 00:02:15,440 EXTRAORDINARY DIVISION. 61 00:02:15,440 --> 00:02:16,760 AS WE'VE TALKED ABOUT I THINK 62 00:02:16,760 --> 00:02:17,840 MULTIPLE TIMES OVER THE PAST 63 00:02:17,840 --> 00:02:20,160 SEVERAL YEARS, THE PROGRESS IN 64 00:02:20,160 --> 00:02:23,240 HIV DISEASE OVER THE PAST FOUR 65 00:02:23,240 --> 00:02:26,440 DECADES IS REALLY UNSURPASSED, I 66 00:02:26,440 --> 00:02:28,040 THINK, IN WHAT HAS HAPPENED IN 67 00:02:28,040 --> 00:02:28,920 MEDICINE DURING THAT TIME, BOTH 68 00:02:28,920 --> 00:02:32,720 IN TERMS OF CLINICAL IMPACT AND 69 00:02:32,720 --> 00:02:34,280 ALSO GLOBAL IMPACT, WHICH IS 70 00:02:34,280 --> 00:02:38,760 REALLY LIKE NOTHING THAT I THINK 71 00:02:38,760 --> 00:02:40,280 HAS BEEN SEEN IN THE HISTORY OF 72 00:02:40,280 --> 00:02:40,840 MEDICINE. 73 00:02:40,840 --> 00:02:43,000 AND YET HERE WE ARE WITH STILL A 74 00:02:43,000 --> 00:02:44,800 TREMENDOUS AMOUNT OF WORK STILL 75 00:02:44,800 --> 00:02:49,040 TO DO, DESPITE ALL OF THAT 76 00:02:49,040 --> 00:02:50,040 PROGRESS, AND AS I THINK ABOUT 77 00:02:50,040 --> 00:02:52,440 MY COLLABORATIONS AND ALL OF OUR 78 00:02:52,440 --> 00:02:53,280 COLLABORATIONS WITH PEOPLE IN 79 00:02:53,280 --> 00:02:55,800 THE DIVISION, WITH EVERYONE HERE 80 00:02:55,800 --> 00:02:57,680 FROM THE DIVISION OF AIDS, 81 00:02:57,680 --> 00:02:58,680 PEOPLE IN THE COMMUNITY WHO'VE 82 00:02:58,680 --> 00:03:01,680 WORKED SO HARD, INVESTIGATORS, 83 00:03:01,680 --> 00:03:05,360 THERE REALLY IS NOT ONLY A 84 00:03:05,360 --> 00:03:06,320 TREMENDOUS AMOUNT THAT WE CAN 85 00:03:06,320 --> 00:03:08,240 DO, BUT I'M CONFIDENT THAT THESE 86 00:03:08,240 --> 00:03:09,440 SUCCESSES WILL CONTINUE, SO I 87 00:03:09,440 --> 00:03:11,080 WANT TO THANK EVERYONE AND WE 88 00:03:11,080 --> 00:03:12,440 REALLY LOOK FORWARD TO THIS 89 00:03:12,440 --> 00:03:15,800 AFTERNOON'S MEETING AND TO MUCH 90 00:03:15,800 --> 00:03:18,000 MORE PROGRESS IN PREVENTING AND 91 00:03:18,000 --> 00:03:19,200 TREATING HIV IN THE YEARS TO 92 00:03:19,200 --> 00:03:21,280 COME WITH ALL OF THE EFFORTS 93 00:03:21,280 --> 00:03:22,800 FROM PEOPLE IN THE DIVISION AT 94 00:03:22,800 --> 00:03:23,120 NIAID. 95 00:03:23,120 --> 00:03:27,400 SO THANK YOU. 96 00:03:27,400 --> 00:03:29,480 LET ME TURN IT OVER TO YOU, 97 00:03:29,480 --> 00:03:31,040 DR. DIEFFENBACH, FOR THE 98 00:03:31,040 --> 00:03:35,960 DIRECTOR'S REPORT. 99 00:03:35,960 --> 00:03:38,680 >>THANK YOU, KEN, AND FOR YOUR 100 00:03:38,680 --> 00:03:39,200 INCREDIBLY KIND REMARKS. 101 00:03:39,200 --> 00:03:41,880 I THINK THE STRENGTH OF NIAID 102 00:03:41,880 --> 00:03:43,960 AND DIVISION OF AIDS IS CENTERED 103 00:03:43,960 --> 00:03:47,440 IN COMMUNITY. 104 00:03:47,440 --> 00:03:48,400 THE COMMUNITY WE SEEK TO SERVE 105 00:03:48,400 --> 00:03:49,720 AND THE RESEARCH COMMUNITY. 106 00:03:49,720 --> 00:03:53,200 AND IT'S THAT WONDERFUL 107 00:03:53,200 --> 00:03:54,520 COMBINATION OF ALL FEELING WE'RE 108 00:03:54,520 --> 00:03:58,440 ON THE SAME PAGE, MOVING FORWARD 109 00:03:58,440 --> 00:04:01,080 TO ADDRESS ALL THE THINGS WE CAN 110 00:04:01,080 --> 00:04:03,960 POSSIBLY ADDRESS THROUGH 111 00:04:03,960 --> 00:04:05,840 MEDICINE TO HELP BRING AN END TO 112 00:04:05,840 --> 00:04:09,320 THE GLOBAL PANDEMIC. 113 00:04:09,320 --> 00:04:11,360 SO I HAVE THIS CHANCE TO GIVE MY 114 00:04:11,360 --> 00:04:11,760 DIRECTOR'S REPORT. 115 00:04:11,760 --> 00:04:13,480 THIS IS GOING TO BE A LITTLE BIT 116 00:04:13,480 --> 00:04:15,880 DIFFERENT TODAY BECAUSE WE'RE 117 00:04:15,880 --> 00:04:18,280 SPENDING A LOT OF TIME IN OUR 118 00:04:18,280 --> 00:04:19,600 SESSION TODAY TALKING ABOUT 119 00:04:19,600 --> 00:04:21,240 LESSONS LEARNED, BOTH POSITIVE 120 00:04:21,240 --> 00:04:23,200 AND NEGATIVE, FROM SARS-COV-2. 121 00:04:23,200 --> 00:04:24,760 SO SOME OF THE THINGS YOU WILL 122 00:04:24,760 --> 00:04:26,280 USUALLY EXPECT TO SEE FROM ME 123 00:04:26,280 --> 00:04:30,000 ARE PUT OFF UNTIL THE MAY 124 00:04:30,000 --> 00:04:30,320 MEETING. 125 00:04:30,320 --> 00:04:31,640 SO LET'S GO AHEAD AND GET 126 00:04:31,640 --> 00:04:32,640 STARTED. 127 00:04:32,640 --> 00:04:35,360 NEXT SLIDE, PLEASE. 128 00:04:35,360 --> 00:04:37,320 SO KEN HAS ALREADY STOLEN SOME 129 00:04:37,320 --> 00:04:38,080 OF MY THUNDER. 130 00:04:38,080 --> 00:04:41,080 I WANT TO THANK THE FOLLOWING 131 00:04:41,080 --> 00:04:41,920 PEOPLE. 132 00:04:41,920 --> 00:04:44,480 RITU AGARWAL. 133 00:04:44,480 --> 00:04:54,640 IAN FRANK. 134 00:04:56,040 --> 00:05:02,520 ANITA GUPTA AND LAST BUT NOT 135 00:05:02,520 --> 00:05:06,160 LEAST KEN, YOU HAVE A SUITABLY 136 00:05:06,160 --> 00:05:07,440 SIGNED CERTIFICATE SUITABLE FOR 137 00:05:07,440 --> 00:05:08,560 FRAMING, IT SHOULD BE ON YOUR 138 00:05:08,560 --> 00:05:09,680 WAY TO YOUR OFFICES. 139 00:05:09,680 --> 00:05:13,720 SO AGAIN, THANK YOU ALL FOR 140 00:05:13,720 --> 00:05:17,440 PARTICIPATING AND BEING PART OF 141 00:05:17,440 --> 00:05:18,440 JUST BEING THERE FOR US. 142 00:05:18,440 --> 00:05:19,560 WE DO MORE THAN OTHER DIVISIONS 143 00:05:19,560 --> 00:05:24,000 IN TERMS OF ENGAGING OUR 144 00:05:24,000 --> 00:05:25,000 COMMITTEE, AND WE THINK IT PAYS 145 00:05:25,000 --> 00:05:28,080 OFF. 146 00:05:28,080 --> 00:05:29,440 I'D ALSO LIKE TO ANNOUNCE THAT 147 00:05:29,440 --> 00:05:31,240 WE'VE HIRED ANDREW VERNON AS 148 00:05:31,240 --> 00:05:34,360 CHIEF OF THE TB CLINICAL 149 00:05:34,360 --> 00:05:38,840 RESEARCH BRANCH. 150 00:05:38,840 --> 00:05:40,240 ANDY COMES TO US FROM CDC, WHERE 151 00:05:40,240 --> 00:05:45,080 HE WAS A DRIVER IN THE TB 152 00:05:45,080 --> 00:05:48,440 CLINICAL TRIALS GROUP AT CDC. 153 00:05:48,440 --> 00:05:49,960 THIS IS A REALLY GOOD FIT FOR 154 00:05:49,960 --> 00:05:51,720 US, AND WE LOOK FORWARD TO 155 00:05:51,720 --> 00:05:54,120 REALLY DOING MORE IN TB 156 00:05:54,120 --> 00:05:55,440 THERAPEUTICS AND VACCINES IN THE 157 00:05:55,440 --> 00:05:56,200 NEAR FUTURE. 158 00:05:56,200 --> 00:06:02,320 SO WELCOME, ANDY. 159 00:06:02,320 --> 00:06:04,320 SO I WANT TO GO TO THE BUDGET 160 00:06:04,320 --> 00:06:04,920 UPDATE. 161 00:06:04,920 --> 00:06:07,000 THOSE OF YOU THAT WERE ON FOR 162 00:06:07,000 --> 00:06:07,800 HUGH'S PRESENTATION HAVE SEEN 163 00:06:07,800 --> 00:06:08,360 THIS ALREADY. 164 00:06:08,360 --> 00:06:09,440 NEXT SLIDE, PLEASE. 165 00:06:09,440 --> 00:06:11,520 THE WHITE HOUSE IS NOT DUE TO 166 00:06:11,520 --> 00:06:12,920 ANNOUNCE THE BUDGET UNTIL LATER 167 00:06:12,920 --> 00:06:14,880 THIS WEEK OR MAYBE NOT UNTIL WE 168 00:06:14,880 --> 00:06:17,120 GET TO THE STATE OF THE UNION. 169 00:06:17,120 --> 00:06:20,480 SO WE DO NOT KNOW WHAT'S IN THE 170 00:06:20,480 --> 00:06:24,200 '24 PRESIDENT'S BUDGET. 171 00:06:24,200 --> 00:06:26,520 BUT WE DO KNOW WHAT WAS IN THE 172 00:06:26,520 --> 00:06:27,600 '23 BUDGET. 173 00:06:27,600 --> 00:06:34,160 WE'VE SEEN THESE NUMBERS, NIAID 174 00:06:34,160 --> 00:06:36,800 RECEIVED SLIGHTLY LESS THAN 175 00:06:36,800 --> 00:06:38,760 3% -- A LITTLE LESS THAN 4% 176 00:06:38,760 --> 00:06:39,960 INCREASE, BUT PLEASE NOTE ON 177 00:06:39,960 --> 00:06:43,600 THIS SLIDE THAT THE AIDS 178 00:06:43,600 --> 00:06:45,240 ALLOCATION IS NOT INCLUDED IN 179 00:06:45,240 --> 00:06:49,520 THIS TOTAL. 180 00:06:49,520 --> 00:06:52,520 AND THE OAR HAS NOW TAKEN THE 181 00:06:52,520 --> 00:06:53,960 AIDS INCREASE AND DIVIDED IT UP 182 00:06:53,960 --> 00:06:57,040 AMONG THE INSTITUTES, AND WE ARE 183 00:06:57,040 --> 00:07:00,480 SET TO, AS A DIVISION, TAKE FULL 184 00:07:00,480 --> 00:07:02,520 ADVANTAGE OF THE BUDGET INCREASE 185 00:07:02,520 --> 00:07:04,200 THAT THE CONGRESS GAVE TO THE 186 00:07:04,200 --> 00:07:07,800 OAR. 187 00:07:07,800 --> 00:07:09,280 SO WE HAVE THE ESTABLISHED 188 00:07:09,280 --> 00:07:12,240 PAYLINE HAS GONE FROM THE TENTH 189 00:07:12,240 --> 00:07:16,080 TO THE 11TH PERCENTILE. 190 00:07:16,080 --> 00:07:19,280 WE NEVER RESTRICT OR 191 00:07:19,280 --> 00:07:20,480 DOWN-NEGOTIATE NONCOMPETING OR 192 00:07:20,480 --> 00:07:23,000 COMPETING GRANTS OR CONTRACTS. 193 00:07:23,000 --> 00:07:25,200 CERTAIN RESEARCH INITIATIVES 194 00:07:25,200 --> 00:07:26,640 WILL BE CUT UP TO 20%, AND WE 195 00:07:26,640 --> 00:07:28,840 ESTIMATE A SUCCESS RATE BETWEEN 196 00:07:28,840 --> 00:07:32,280 18 AND 22 FOR THE ENTIRE 197 00:07:32,280 --> 00:07:35,600 INSTITUTE. 198 00:07:35,600 --> 00:07:37,240 SO SOME UPDATES IN TERMS OF THE 199 00:07:37,240 --> 00:07:39,000 SCIENTIFIC PROGRAMS AND OTHER 200 00:07:39,000 --> 00:07:42,320 ACTIVITIES. 201 00:07:42,320 --> 00:07:46,360 SO THIS WAS DISAPPOINTING NEWS 202 00:07:46,360 --> 00:07:51,360 IN SOME WAYS SOMEWHAT EXPECTED 203 00:07:51,360 --> 00:07:52,440 BECAUSE OF THE COMPANION TRIAL 204 00:07:52,440 --> 00:07:57,960 TO THE MEN'S TRIAL MOSAICO TRIAL 205 00:07:57,960 --> 00:08:00,240 ENDED EARLY UNDER THE SAME 206 00:08:00,240 --> 00:08:02,640 CIRCUMSTANCES, SO BASED ON THE 207 00:08:02,640 --> 00:08:05,520 DSMB RECOMMENDATION, MOSAICO HAS 208 00:08:05,520 --> 00:08:08,600 BEEN DISCONTINUED, STUDY 209 00:08:08,600 --> 00:08:09,840 PARTICIPANTS HAVE BEEN NOTIFIED, 210 00:08:09,840 --> 00:08:12,120 AND THE FINDINGS ARE MOVING 211 00:08:12,120 --> 00:08:13,840 QUICKLY TOWARD PUBLICATION AND 212 00:08:13,840 --> 00:08:16,800 RELEASE. 213 00:08:16,800 --> 00:08:18,200 I THINK IT'S IMPORTANT FOR YOU 214 00:08:18,200 --> 00:08:21,840 TO SEE JUST HOW FLAT THIS WAS. 215 00:08:21,840 --> 00:08:24,040 THERE WERE, AT THE END, AN EQUAL 216 00:08:24,040 --> 00:08:26,640 NUMBER OF INFECTIONS IN BOTH 217 00:08:26,640 --> 00:08:28,680 ACTIVE AND PLACEBO, AND YOU CAN 218 00:08:28,680 --> 00:08:30,400 SEE IT TRACKED THE SAME ALL THE 219 00:08:30,400 --> 00:08:30,880 WAY ALONG. 220 00:08:30,880 --> 00:08:35,120 SO AT NO POINT WAS THERE 221 00:08:35,120 --> 00:08:37,160 EVIDENCE OF A SIGNAL THAT WANED 222 00:08:37,160 --> 00:08:40,320 LIKE WE SAW WITH RV144. 223 00:08:40,320 --> 00:08:42,760 IT WAS JUST PLAIN FLAT. 224 00:08:42,760 --> 00:08:48,280 AS HUGH MENTIONED, THE TOTALLY 225 00:08:48,280 --> 00:08:50,000 FRIGHTENING ISSUE THAT WE SAW IN 226 00:08:50,000 --> 00:08:54,640 THIS TRIAL, ONE IS THE STUDY 227 00:08:54,640 --> 00:08:56,440 PARTICIPANTS IN PLACEBO AND 228 00:08:56,440 --> 00:08:59,480 VACCINE ARM HAD A MATCHED 229 00:08:59,480 --> 00:09:02,360 INCIDENCE OF A LITTLE OVER 4%, 230 00:09:02,360 --> 00:09:06,720 WHICH IS REALLY PROBLEMATIC. 231 00:09:06,720 --> 00:09:09,520 REMEMBER THIS IS IN MEN IN 232 00:09:09,520 --> 00:09:11,280 EUROPE, SOUTH AMERICA, AND THE 233 00:09:11,280 --> 00:09:13,520 UNITED STATES, BASICALLY GLOBAL. 234 00:09:13,520 --> 00:09:15,480 AND THIS IS A POPULATION THAT 235 00:09:15,480 --> 00:09:17,320 HAD ACCESS TO PREP. 236 00:09:17,320 --> 00:09:18,640 I THINK THE CHALLENGE WE FACE 237 00:09:18,640 --> 00:09:20,080 GOING FORWARD IS HOW CAN WE 238 00:09:20,080 --> 00:09:21,920 REACH THESE UNREACHABLE PEOPLE 239 00:09:21,920 --> 00:09:26,400 AND PROVIDE THEM THE NECESSARY 240 00:09:26,400 --> 00:09:28,240 SERVICES TO PREVENT ACQUISITION 241 00:09:28,240 --> 00:09:34,920 OF HIV. 242 00:09:34,920 --> 00:09:36,560 ON A MORE POSITIVE NOTE, THE 243 00:09:36,560 --> 00:09:41,520 U.S. PREVENTION SERVICES TASK 244 00:09:41,520 --> 00:09:46,200 FORCE HAS GIVEN THE LONG-ACTING 245 00:09:46,200 --> 00:09:54,400 INJECTABLE OF CA APRETUDE GRADE, 246 00:09:54,400 --> 00:09:55,600 AND THIS IS NOW GOING TO MOVE 247 00:09:55,600 --> 00:09:57,400 THROUGH THEIR PROCESS OF GETTING 248 00:09:57,400 --> 00:09:59,920 VALIDATED AS A GRADE A, WHICH 249 00:09:59,920 --> 00:10:01,200 WILL HOPEFULLY LEAD WITHIN A 250 00:10:01,200 --> 00:10:09,680 YEAR OR TWO TO FULL COVERAGE OF 251 00:10:09,680 --> 00:10:11,480 THIS PREVENTION OPTION UNDER THE 252 00:10:11,480 --> 00:10:12,400 ACA-APPROVED HEALTH PLANS, 253 00:10:12,400 --> 00:10:17,040 BECAUSE THAT IS PART OF THE 254 00:10:17,040 --> 00:10:18,320 LEGISLATION, IS THAT PREVENTION 255 00:10:18,320 --> 00:10:19,960 SERVICES OF GRADE A OR B ARE TO 256 00:10:19,960 --> 00:10:21,520 BE MADE ROUTINELY AVAILABLE. 257 00:10:21,520 --> 00:10:24,000 SO THIS IS A BIG STEP FORWARD. 258 00:10:24,000 --> 00:10:29,600 IT'S IMPORTANT TO NOTE THAT TDF 259 00:10:29,600 --> 00:10:31,880 FTC WAS APPROVED BY THE FDA IN 260 00:10:31,880 --> 00:10:32,080 2012. 261 00:10:32,080 --> 00:10:33,840 IT TOOK THE PREVENTION SERVICES 262 00:10:33,840 --> 00:10:35,960 TASK FORCE ALMOST SIX YEARS 263 00:10:35,960 --> 00:10:39,440 BEFORE THEY GAVE PREP -- ORAL 264 00:10:39,440 --> 00:10:41,560 DAILY PREP A GRADE OF A. 265 00:10:41,560 --> 00:10:46,480 SO THIS IS A BIG STEP FORWARD 266 00:10:46,480 --> 00:10:48,720 FOR USPSTF. 267 00:10:48,720 --> 00:10:51,040 SO NOW I'M GOING TO SPEND SOME 268 00:10:51,040 --> 00:10:54,880 TIME GOING OVER WHAT THE 269 00:10:54,880 --> 00:10:58,960 DIVISION HAS BEEN THROUGH FOR 270 00:10:58,960 --> 00:11:03,560 THE RESPONSE TO THE SARS-COV-2 271 00:11:03,560 --> 00:11:04,760 PANDEMIC. 272 00:11:04,760 --> 00:11:06,960 AND MY ROLE IN THIS IS TO SET 273 00:11:06,960 --> 00:11:08,360 THE STAGE OF THE BIG PICTURE 274 00:11:08,360 --> 00:11:12,640 VIEW OF WHAT WE AS A DIVISION 275 00:11:12,640 --> 00:11:13,680 TACKLED IN TERMS OF WHERE WE 276 00:11:13,680 --> 00:11:15,280 NEED TO THINK ABOUT WHAT WE'VE 277 00:11:15,280 --> 00:11:17,840 DONE RIGHT AND WHAT WE NEED TO 278 00:11:17,840 --> 00:11:19,520 IMPROVE. 279 00:11:19,520 --> 00:11:21,760 IT'S ALSO IMPORTANT TO NOTE THAT 280 00:11:21,760 --> 00:11:25,040 MOST OF THE OFFICES AND PROGRAMS 281 00:11:25,040 --> 00:11:26,120 WILL DEVOTE TIME IN THEIR 282 00:11:26,120 --> 00:11:27,920 PRESENTATIONS TODAY TO THIS 283 00:11:27,920 --> 00:11:28,760 TOPIC. 284 00:11:28,760 --> 00:11:29,600 VIRTUALLY EVERY OFFICE AND 285 00:11:29,600 --> 00:11:31,720 PROGRAM PLAYED A ROLE IN THE 286 00:11:31,720 --> 00:11:33,560 COVID RESPONSE, AND SO TODAY 287 00:11:33,560 --> 00:11:34,880 WHILE WE'RE FOCUSING ON THE 288 00:11:34,880 --> 00:11:37,600 CLINICAL ACTIVITIES, WE REALLY 289 00:11:37,600 --> 00:11:40,680 WANT TO TAKE A STEP BACK AND 290 00:11:40,680 --> 00:11:43,080 HIGHLIGHT THE FACT THAT SO MANY 291 00:11:43,080 --> 00:11:46,800 OF THE BASIC RESEARCH VIROLOGY 292 00:11:46,800 --> 00:11:49,000 LABS ALSO MADE TREMENDOUS 293 00:11:49,000 --> 00:11:53,360 CONTRIBUTIONS TO THE SARS-COV-2 294 00:11:53,360 --> 00:11:55,320 PANDEMIC. 295 00:11:55,320 --> 00:11:58,400 LIKE CLINICAL SITES PIVOTING TO 296 00:11:58,400 --> 00:11:59,040 WORK ON COVID. 297 00:11:59,040 --> 00:12:01,120 MANY OF OUR PRE-CLINICAL AND 298 00:12:01,120 --> 00:12:03,400 BASIC RESEARCH VIROLOGY LABS 299 00:12:03,400 --> 00:12:07,680 ALSO PIVOTED AND BECAME, IN MANY 300 00:12:07,680 --> 00:12:10,560 WAYS, THE CORNERSTONE OF 301 00:12:10,560 --> 00:12:12,520 ANSWERING THE QUESTIONS IN 302 00:12:12,520 --> 00:12:14,360 CORONAVIRUS BIOLOGY. 303 00:12:14,360 --> 00:12:16,320 SO THROUGH THEIR EFFORTS, THE 304 00:12:16,320 --> 00:12:18,000 DIVISION REALLY HAD A 305 00:12:18,000 --> 00:12:21,120 TWO-PRONGED ATTACK. 306 00:12:21,120 --> 00:12:21,440 ON 307 00:12:21,440 --> 00:12:22,680 SARS-COV-2. 308 00:12:22,680 --> 00:12:25,280 ONE ARM DEFINING THE BASIC ARMS 309 00:12:25,280 --> 00:12:26,880 OF I MU NOLG, VIROLOGY, AND THE 310 00:12:26,880 --> 00:12:29,240 SECOND PLAYING PIVOTAL ROLES IN 311 00:12:29,240 --> 00:12:30,240 DEVELOPING VACCINES, 312 00:12:30,240 --> 00:12:32,080 THERAPEUTICS AND MONOCLONAL 313 00:12:32,080 --> 00:12:34,120 ANTIBODIES TO PREVENT AND TREAT 314 00:12:34,120 --> 00:12:34,480 SARS-COV-2. 315 00:12:34,480 --> 00:12:36,440 SO I'M GOING TO FOCUS MY REMARKS 316 00:12:36,440 --> 00:12:39,080 FROM NOW ON ON THE ISSUES AROUND 317 00:12:39,080 --> 00:12:40,280 THE CLINICAL, SO YOU CAN SEE 318 00:12:40,280 --> 00:12:41,480 WHAT WE DID. 319 00:12:41,480 --> 00:12:42,800 BUT I REALLY WANTED YOU TO 320 00:12:42,800 --> 00:12:45,640 UNDERSTAND THAT REALLY WE HAD A 321 00:12:45,640 --> 00:12:47,840 INFLUENCE ACROSS THE ENTIRE 322 00:12:47,840 --> 00:12:55,480 SPECTRUM OF RESEARCH ACTIVITIES. 323 00:12:55,480 --> 00:12:57,480 SO EARLY ON, IN APRIL OF 2020, 324 00:12:57,480 --> 00:13:01,200 THE NIH LAUNCHED THE ACTIVE 325 00:13:01,200 --> 00:13:03,120 PROGRAM, ACCELERATING COVID 326 00:13:03,120 --> 00:13:04,200 THERAPEUTIC INTERVENTIONS AND 327 00:13:04,200 --> 00:13:06,000 VACCINES, THE MISSION OF WHICH 328 00:13:06,000 --> 00:13:08,880 WAS TO DEVELOP COORDINATED 329 00:13:08,880 --> 00:13:11,160 RESEARCH RESPONSE TO SPEED 330 00:13:11,160 --> 00:13:14,560 TREATMENT AND VACCINE OPTIONS 331 00:13:14,560 --> 00:13:18,720 FOR CORONAVIRUS DISEASE. 332 00:13:18,720 --> 00:13:22,440 SO THERE WERE ABSOLUTELY SOME 333 00:13:22,440 --> 00:13:24,040 CRITICAL AREAS THAT WERE 334 00:13:24,040 --> 00:13:24,640 TACKLED. 335 00:13:24,640 --> 00:13:26,600 THERE WAS A VACCINE GROUP, A 336 00:13:26,600 --> 00:13:27,640 PRE-CLINICAL GROUP, A CLINICAL 337 00:13:27,640 --> 00:13:31,080 TRIALS CAPACITY GROUP, AND 338 00:13:31,080 --> 00:13:31,920 THERAPEUTICS, CLINICAL 339 00:13:31,920 --> 00:13:33,480 THERAPEUTICS GROUP THAT WERE ALL 340 00:13:33,480 --> 00:13:35,960 FORMED THAT DEALT WITH 341 00:13:35,960 --> 00:13:39,440 EVERYTHING FROM VACCINE CLINICAL 342 00:13:39,440 --> 00:13:41,240 TRIALS, EVALUATION IN ANIMAL 343 00:13:41,240 --> 00:13:47,360 MODELS, SURVEYING CLINICAL TRIAL 344 00:13:47,360 --> 00:13:54,000 NETWORK INVENTORY, BUT ALSO 345 00:13:54,000 --> 00:13:57,440 MASTER PROTOCOLS TO EVALUATE 346 00:13:57,440 --> 00:13:57,880 THERAPEUTIC. 347 00:13:57,880 --> 00:14:03,280 SO GRAPHICALLY ACTIL LOOKS LIKE 348 00:14:03,280 --> 00:14:04,800 THIS. 349 00:14:04,800 --> 00:14:10,080 THERE WERE SUBGROUPS, THERE'S 350 00:14:10,080 --> 00:14:13,720 ACTIV 1-6. 351 00:14:13,720 --> 00:14:15,560 ACTIV 2 WAS RUN LARGELY BY THE 352 00:14:15,560 --> 00:14:18,640 TREATMENT -- THE THERAPEUTICS 353 00:14:18,640 --> 00:14:19,520 RESEARCH PROGRAM IN 354 00:14:19,520 --> 00:14:21,000 COLLABORATION WITH THE AIDS 355 00:14:21,000 --> 00:14:22,240 CLINICAL TRIALS GROUP THAT 356 00:14:22,240 --> 00:14:25,200 EVALUATED AGENTS INCLUDING A 357 00:14:25,200 --> 00:14:27,360 NUMBER OF MONOCLONAL ANTIBODIES 358 00:14:27,360 --> 00:14:31,240 AND ARE CURRENTLY WORKING IN 359 00:14:31,240 --> 00:14:35,600 ACTIV2 TO EVALUATE THE PROTEASE 360 00:14:35,600 --> 00:14:39,200 INHIBITOR. 361 00:14:39,200 --> 00:14:40,840 ACTIV3 WAS LARGELY LED BY CLIFF 362 00:14:40,840 --> 00:14:42,880 LANE'S GROUP. 363 00:14:42,880 --> 00:14:44,560 YES, THAT'S WHAT WE'RE FOCUSED 364 00:14:44,560 --> 00:14:45,200 ON. 365 00:14:45,200 --> 00:14:46,720 AND PETER WILL TALK ABOUT THIS 366 00:14:46,720 --> 00:14:49,360 AT LENGTH. 367 00:14:49,360 --> 00:14:57,240 AS WILL MANA SHEA AND CAROL WHO 368 00:14:57,240 --> 00:14:58,160 WERE ESSENTIAL PARTNERS IN TERMS 369 00:14:58,160 --> 00:14:59,880 OF DEVELOPMENT OF SITES AND THE 370 00:14:59,880 --> 00:15:01,400 REGULATORY OVERSIGHT OF THESE 371 00:15:01,400 --> 00:15:07,160 TRIALS. 372 00:15:07,160 --> 00:15:10,440 SO THIS IS THE MASTER PROTOCOL. 373 00:15:10,440 --> 00:15:12,600 AGENTS CAME IN AT THE PHASE 374 00:15:12,600 --> 00:15:13,840 2 LEVEL AFTER BEING SELECTED BY 375 00:15:13,840 --> 00:15:14,880 THE AGENT SELECTION COMMITTEE. 376 00:15:14,880 --> 00:15:17,120 WE HAD OVER 200 CLINICAL TRIAL 377 00:15:17,120 --> 00:15:19,160 SITES. 378 00:15:19,160 --> 00:15:20,920 THEY WERE SMALL PHASE 2s WHERE 379 00:15:20,920 --> 00:15:26,400 WE LOOKED AT, THROUGH THE DSMB, 380 00:15:26,400 --> 00:15:27,720 APPROXIMATELY 110 PEOPLE AND IF 381 00:15:27,720 --> 00:15:29,360 THE AGENT SHOWED PROMISE, IT 382 00:15:29,360 --> 00:15:32,160 KEPT ON GOING INTO PHASE 3. 383 00:15:32,160 --> 00:15:34,280 IF IT DIDN'T, ACTIVITY WAS 384 00:15:34,280 --> 00:15:39,320 ENDED. 385 00:15:39,320 --> 00:15:41,480 WE WERE THE REGULATORY SPONSOR 386 00:15:41,480 --> 00:15:43,160 FOR ACTIV 2 AND THE ULTIMATE 387 00:15:43,160 --> 00:15:45,560 GOAL WAS TO GET BETTER THERAPIES 388 00:15:45,560 --> 00:15:47,880 TO ADVANCE TO EMERGENCY USE 389 00:15:47,880 --> 00:15:53,000 AUTHORIZATION. 390 00:15:53,000 --> 00:15:55,320 THE PARALLEL TRACK ON THE 391 00:15:55,320 --> 00:16:00,320 VACCINE AND MONOCLONAL ANTIBODY 392 00:16:00,320 --> 00:16:02,200 SIDE WAS THE NETWORK FORMED BY 393 00:16:02,200 --> 00:16:02,960 NETWORKS FROM WITHIN THE 394 00:16:02,960 --> 00:16:07,800 DIVISION OF AIDS, THE HVTN, THE 395 00:16:07,800 --> 00:16:12,240 HPTN, AND THE IDCRC NETWORK IN 396 00:16:12,240 --> 00:16:14,040 DMID, WHICH IS THEIR INFECTIOUS 397 00:16:14,040 --> 00:16:14,440 DISEASE NETWORK. 398 00:16:14,440 --> 00:16:15,880 AND THEIR PLATFORM WAS SIMILAR. 399 00:16:15,880 --> 00:16:18,200 THEY HAD HARMONIZED -- THEY 400 00:16:18,200 --> 00:16:19,440 WANTED HARMONIZED EFFICACY 401 00:16:19,440 --> 00:16:21,040 TRIALS WITH THE COLLABORATING 402 00:16:21,040 --> 00:16:23,640 CLINICAL TRIALS NETWORKS. 403 00:16:23,640 --> 00:16:27,120 THEY HAD LABORATORIES THAT 404 00:16:27,120 --> 00:16:30,960 LOOKED AT EVERYTHING AT THE 405 00:16:30,960 --> 00:16:32,040 ANTIBODY RESPONSES AS WELL AS 406 00:16:32,040 --> 00:16:35,360 T-CELL RESPONSES, AND THAT WAS A 407 00:16:35,360 --> 00:16:37,440 PARTICULAR PLATFORM THAT ALSO 408 00:16:37,440 --> 00:16:42,560 ENGAGED BARDA AND THE BRC IN 409 00:16:42,560 --> 00:16:44,640 TERMS OF SETTING UP THE 410 00:16:44,640 --> 00:16:48,040 QUALIFIED ASSAYS FOR MEASURING 411 00:16:48,040 --> 00:16:48,480 RESPONSES. 412 00:16:48,480 --> 00:16:50,560 WE HAD AN INTEGRATED DATA SAFETY 413 00:16:50,560 --> 00:16:51,560 MONITORING BOARD THAT OVERSAW 414 00:16:51,560 --> 00:16:54,280 ALL THE VACCINE TRIALS, AND THE 415 00:16:54,280 --> 00:16:55,680 WAY THE DATA WAS BEING 416 00:16:55,680 --> 00:16:57,240 COLLECTED, WE HAD THE ABILITY 417 00:16:57,240 --> 00:17:01,640 THEN TO LOOK BETWEEN TRIAL 418 00:17:01,640 --> 00:17:02,840 STATISTICAL GROUP CORRELATES OF 419 00:17:02,840 --> 00:17:03,920 PROTECTION. 420 00:17:03,920 --> 00:17:05,880 THIS WAS A REALLY AMAZING TEAM 421 00:17:05,880 --> 00:17:08,600 LIKE THE ACTIV 2 TEAM. 422 00:17:08,600 --> 00:17:10,720 THESE WERE THE PRODUCTS THAT 423 00:17:10,720 --> 00:17:11,920 WERE EVALUATED. 424 00:17:11,920 --> 00:17:17,040 WE WORKED ON THE MODERNA 425 00:17:17,040 --> 00:17:19,600 VACCINE, AND THAT RECEIVED EUA 426 00:17:19,600 --> 00:17:24,920 ALL THE WAY DOWN TO SIX MONTHS. 427 00:17:24,920 --> 00:17:26,680 JANUARY 16, THE EUA HAS BEEN 428 00:17:26,680 --> 00:17:28,520 ISSUED AND IT AVAILABLE 18 AND 429 00:17:28,520 --> 00:17:31,200 UP. 430 00:17:31,200 --> 00:17:33,720 ASTRAZENECA WAS EVALUATED AND 431 00:17:33,720 --> 00:17:35,120 WHILE IT WASN'T AUTHORIZED IN 432 00:17:35,120 --> 00:17:37,000 THIS COUNTRY, IT WAS AUTHORIZED 433 00:17:37,000 --> 00:17:39,840 IN OVER 89 COUNTRIES. 434 00:17:39,840 --> 00:17:43,000 NOVAVAX MOVED FORWARD AND HAS 435 00:17:43,000 --> 00:17:45,600 RECEIVED AN EUA. 436 00:17:45,600 --> 00:17:48,000 THE ONE THAT IS STILL IN THE 437 00:17:48,000 --> 00:17:50,000 PROCESS OF COMPLETING THEIR 438 00:17:50,000 --> 00:17:56,040 CLINICAL TRIAL IS THE GSK SANOFI 439 00:17:56,040 --> 00:17:57,240 PROTEIN, AND THAT IS STILL 440 00:17:57,240 --> 00:18:00,400 ONGOING. 441 00:18:00,400 --> 00:18:04,440 SO WITH THAT, I WILL SWITCH 442 00:18:04,440 --> 00:18:06,840 GEARS NOW AND TALK ABOUT THE 443 00:18:06,840 --> 00:18:08,800 SBIR CONTRACT TOPICS THAT WE 444 00:18:08,800 --> 00:18:12,760 BRING FORWARD TO YOU FOR 445 00:18:12,760 --> 00:18:13,560 APPROVAL EVERY JANUARY. 446 00:18:13,560 --> 00:18:14,840 SO LET ME GO TO THE NEXT SLIDE, 447 00:18:14,840 --> 00:18:15,720 PLEASE. 448 00:18:15,720 --> 00:18:22,000 WE HAVE FOUR TOPICS TODAY. 449 00:18:22,000 --> 00:18:23,960 THESE ARE DESIGNED TO COMPLEMENT 450 00:18:23,960 --> 00:18:27,360 THE GRANT PROGRAMS THAT ARE 451 00:18:27,360 --> 00:18:31,280 FUNDED COMPETITIVELY EACH YEAR. 452 00:18:31,280 --> 00:18:37,240 REMEMBER, SBIR MONEY IS A 453 00:18:37,240 --> 00:18:39,120 CONGRESSIONALLY MANDATED 454 00:18:39,120 --> 00:18:40,920 SETASIDE THAT COMES OFF THE TOP 455 00:18:40,920 --> 00:18:45,160 OF THE NIH BUDGET RUNNING 2 1/2% 456 00:18:45,160 --> 00:18:46,560 PER YEAR. 457 00:18:46,560 --> 00:18:53,200 SO IT IS IMPORTANT THAT THE TI 458 00:18:53,200 --> 00:18:54,400 DIVISION FIGURE OUT HOW TO USE 459 00:18:54,400 --> 00:18:55,960 THESE ESSENTIALLY SETASIDE 460 00:18:55,960 --> 00:18:57,600 DOLLARS AS EFFECTIVELY AS 461 00:18:57,600 --> 00:18:58,280 POSSIBLE. 462 00:18:58,280 --> 00:19:00,560 ONE WAY WE CAN DO THAT IS 463 00:19:00,560 --> 00:19:01,640 THROUGH THESE CONTRACT 464 00:19:01,640 --> 00:19:01,960 SOLICITATIONS. 465 00:19:01,960 --> 00:19:03,400 SO WE HAVE FOUR TOPICS AS I 466 00:19:03,400 --> 00:19:03,880 SAID. 467 00:19:03,880 --> 00:19:11,320 FIRST TOPIC, LOOKING AT 468 00:19:11,320 --> 00:19:14,120 IMPROVING DELIVERY OF BROAD 469 00:19:14,120 --> 00:19:15,560 NEUTRALIZING MONOCLONAL 470 00:19:15,560 --> 00:19:16,200 ANTIBODIES. 471 00:19:16,200 --> 00:19:18,520 CAN DEVICES OR MATERIALS BE 472 00:19:18,520 --> 00:19:21,160 DEVISED TO EASE AND IMPROVE THE 473 00:19:21,160 --> 00:19:23,120 DELIVERY OF NEUTRALIZING 474 00:19:23,120 --> 00:19:23,440 ANTIBODIES? 475 00:19:23,440 --> 00:19:27,600 WHILE THIS IS FOCUSED FROM OUR 476 00:19:27,600 --> 00:19:32,440 PERSPECTIVE ON HIV-DIRECTED 477 00:19:32,440 --> 00:19:35,280 NEUTRALIZING MONOCLONAL 478 00:19:35,280 --> 00:19:36,680 ANTIBODIES, THOSE OF YOU WHO SAW 479 00:19:36,680 --> 00:19:37,640 "THE WASHINGTON POST" THIS 480 00:19:37,640 --> 00:19:38,600 MORNING, CAROLYN JOHNSON HAD A 481 00:19:38,600 --> 00:19:41,080 VERY INTERESTING ARTICLE ON THE 482 00:19:41,080 --> 00:19:43,040 IMPACT OF MONOCLONAL ANTIBODIES 483 00:19:43,040 --> 00:19:46,880 IN INFECTIOUS DISEASE RESEARCH 484 00:19:46,880 --> 00:19:47,400 WRIT LARGE. 485 00:19:47,400 --> 00:19:50,360 SO THIS IS A VERY IMPORTANT 486 00:19:50,360 --> 00:19:57,240 TOPIC THAT HAS EVENTUALLY -- 487 00:19:57,240 --> 00:19:58,160 GENERALIZABLE ACROSS THE 488 00:19:58,160 --> 00:20:00,120 SPECTRUM OF DISEASES, INCLUDING 489 00:20:00,120 --> 00:20:01,160 MALARIA, AS YOU SAW IF YOU 490 00:20:01,160 --> 00:20:01,840 LOOKED AT THAT ARTICLE. 491 00:20:01,840 --> 00:20:06,240 SO YOU CAN SEE THE GOAL IS TO 492 00:20:06,240 --> 00:20:07,560 DEVELOP MATERIALS THAT CAN 493 00:20:07,560 --> 00:20:09,840 SUSTAIN DELIVERY OF MONOCLONAL 494 00:20:09,840 --> 00:20:13,120 ANTIBODIES. 495 00:20:13,120 --> 00:20:15,080 SO THE KINDS OF ACTIVITIES THAT 496 00:20:15,080 --> 00:20:19,040 ARE ALLOWED ARE OPTIMIZATION OF 497 00:20:19,040 --> 00:20:20,280 FORMULATION IN PHASE ONE AND 498 00:20:20,280 --> 00:20:23,240 THEN PROOF OF CONCEPT TESTING IN 499 00:20:23,240 --> 00:20:24,960 RELEVANT ANIMAL MODELS 500 00:20:24,960 --> 00:20:28,480 ESTABLISHING QA/QC METHODOLOGY 501 00:20:28,480 --> 00:20:34,400 FOR DEVELOPING BNAB 502 00:20:34,400 --> 00:20:35,840 FORMULATIONS, BUT ULTIMATE GOAL 503 00:20:35,840 --> 00:20:37,240 IS TO PREPARE A REGULATORY 504 00:20:37,240 --> 00:20:38,560 PACKAGE FOR NEXT STEPS OUT OF 505 00:20:38,560 --> 00:20:41,280 THIS CONTRACT. 506 00:20:41,280 --> 00:20:49,560 SO THAT'S TOPIC ONE. 507 00:20:49,560 --> 00:20:51,240 TO PICK 2 IS ONE THAT WE THINK 508 00:20:51,240 --> 00:20:52,920 IS CRITICALLY IMPORTANT AND 509 00:20:52,920 --> 00:20:54,080 WOULD REALLY LIKE TO SEE 510 00:20:54,080 --> 00:20:55,080 INDUSTRY JUMP INTO THIS. 511 00:20:55,080 --> 00:20:56,800 IF YOU THINK ABOUT WHAT WE 512 00:20:56,800 --> 00:20:59,360 ALREADY KNOW ABOUT DIRECT ACTING 513 00:20:59,360 --> 00:21:01,400 ANTIVIRALS FOR HEPATITIS C, WE 514 00:21:01,400 --> 00:21:02,400 KNOW THAT ORAL MEDICATION 515 00:21:02,400 --> 00:21:09,320 DELIVERED FOR ANYWHERE BETWEEN C 516 00:21:09,320 --> 00:21:12,440 AT A LEVEL OF BETWEEN 95 AND 517 00:21:12,440 --> 00:21:14,320 100%. 518 00:21:14,320 --> 00:21:17,280 WE SHOULD BE ABLE, THROUGH OUR 519 00:21:17,280 --> 00:21:20,880 EXPERIENCE WITH LONG-ACTING 520 00:21:20,880 --> 00:21:22,160 MEDICINES, TO BE ABLE TO COME UP 521 00:21:22,160 --> 00:21:25,200 WITH A ONE-DOSE CURE, ONE-DOSE 522 00:21:25,200 --> 00:21:26,600 TREATMENT FOR HEPATITIS C SO 523 00:21:26,600 --> 00:21:28,800 THAT'S OUR FUNDAMENTAL GOAL IN 524 00:21:28,800 --> 00:21:32,960 THIS PROJECT, IS TO DEVELOP SAFE 525 00:21:32,960 --> 00:21:37,560 AND SUSTAINED DELIVERY THAT CAN 526 00:21:37,560 --> 00:21:39,000 ESSENTIALLY BE ONE SHOT OR ONE 527 00:21:39,000 --> 00:21:41,920 PATCH OR ONE DELIVERY METHOD 528 00:21:41,920 --> 00:21:45,040 THAT COULD BE DEPLOYED IN REMOTE 529 00:21:45,040 --> 00:21:47,960 SETTINGS, WOULD MITIGATE ANY 530 00:21:47,960 --> 00:21:48,920 DRUG RESISTANCE OR 531 00:21:48,920 --> 00:21:51,120 NONCOMPLIANCE, BUT IT WOULD 532 00:21:51,120 --> 00:21:52,960 REALLY SIMPLIFY AND HELP US GET 533 00:21:52,960 --> 00:21:55,920 CLOSER TO THE ABILITY TO USE THE 534 00:21:55,920 --> 00:21:57,520 MEDICATIONS TO ERADICATE 535 00:21:57,520 --> 00:22:02,720 HEPATITIS C AGAIN, SO THE IDEA, 536 00:22:02,720 --> 00:22:07,160 THE LONG-RANGE GOAL OF THIS IS 537 00:22:07,160 --> 00:22:09,400 DEVELOP THE CONCEPT AND REALLY 538 00:22:09,400 --> 00:22:12,000 ENGAGE IN IND-DIRECTED 539 00:22:12,000 --> 00:22:14,200 PHARMACOLOGY AND TOXICOLOGY IN 540 00:22:14,200 --> 00:22:16,080 SUITABLE ANIMAL M MODELS THAT WL 541 00:22:16,080 --> 00:22:17,400 GIVE US THIS KIND OF SUSTAINED 542 00:22:17,400 --> 00:22:19,680 RELEASE THAT WILL GIVE US THE 543 00:22:19,680 --> 00:22:22,200 ABILITY TO, THROUGH THESE -- 544 00:22:22,200 --> 00:22:25,800 THIS ADVANCE, TREAT AND CURE 545 00:22:25,800 --> 00:22:27,240 HEPATITIS C AS EFFECTIVELY AS WE 546 00:22:27,240 --> 00:22:35,200 CAN WITH ORAL MEDICATIONS. 547 00:22:35,200 --> 00:22:36,520 NEXT, AN AREA THAT'S REALLY 548 00:22:36,520 --> 00:22:39,040 CRITICAL FOR HIV CURE, JUST IN 549 00:22:39,040 --> 00:22:43,120 GENERAL, IS BEING ABLE TO HAVE 550 00:22:43,120 --> 00:22:44,640 REALLY RAPID DIAGNOSTIC ASSAYS 551 00:22:44,640 --> 00:22:50,480 FOR ACUTE HIV AND/OR REBOUND. 552 00:22:50,480 --> 00:22:52,440 ONE OF THE QUESTIONS WE GET ALL 553 00:22:52,440 --> 00:22:54,000 ALONG IN STRUCTURED TREATMENT 554 00:22:54,000 --> 00:22:55,040 INTERRUPTION IS HOW AM I GOING 555 00:22:55,040 --> 00:22:57,080 TO KNOW IF I'M REBOUNDING. 556 00:22:57,080 --> 00:22:59,760 SO BY DEVELOPING THESE KINDS OF 557 00:22:59,760 --> 00:23:03,240 TOOLS THAT WOULD ALLOW STUDY 558 00:23:03,240 --> 00:23:04,480 PARTICIPANTS AND JUST PATIENTS 559 00:23:04,480 --> 00:23:06,120 IN GENERAL TO MONITOR THEIR 560 00:23:06,120 --> 00:23:08,800 VIRAL LOAD ON THEIR OWN, THIS 561 00:23:08,800 --> 00:23:10,320 COULD BE A POTENTIAL GAME 562 00:23:10,320 --> 00:23:13,400 CHANGER TO HELP PEOPLE STAY VEER 563 00:23:13,400 --> 00:23:14,680 LOGICALLY SUPPRESSED IF THEY'RE 564 00:23:14,680 --> 00:23:17,880 ON MEDICATION AND/OR 565 00:23:17,880 --> 00:23:19,080 PARTICIPATING IN RESEARCH 566 00:23:19,080 --> 00:23:23,440 PROTOCOLS. 567 00:23:23,440 --> 00:23:24,680 SO THERE'S BEEN SOME WORK DONE 568 00:23:24,680 --> 00:23:26,520 IN THIS AREA ALREADY. 569 00:23:26,520 --> 00:23:30,360 WE WANT TO EXPAND PROTOTYPE 570 00:23:30,360 --> 00:23:32,760 ASSAYS, DEVELOP PROCESS CONTROLS 571 00:23:32,760 --> 00:23:40,720 FOR SUCH KITS THAT FACILITATE 572 00:23:40,720 --> 00:23:41,400 COMMERCIALIZATION. 573 00:23:41,400 --> 00:23:43,800 IN PHASE TWO, HAVE THE TEAM 574 00:23:43,800 --> 00:23:45,160 DEVELOP PRODUCT DEVELOPMENT AND 575 00:23:45,160 --> 00:23:46,160 REGULATORY STRATEGIES FOR 576 00:23:46,160 --> 00:23:47,880 APPROVAL AND DEMONSTRATION OF 577 00:23:47,880 --> 00:23:49,960 CLINICAL APPLICATION, AND 578 00:23:49,960 --> 00:23:51,800 FINALIZATION OF A COMMERCIAL 579 00:23:51,800 --> 00:23:52,160 PLAN. 580 00:23:52,160 --> 00:23:57,720 AND LAST BUT NOT LEAST, THE 581 00:23:57,720 --> 00:24:01,120 FORTH ONE IS, IN ANOTHER FORM OF 582 00:24:01,120 --> 00:24:02,320 IMPROVED DIAGNOSTIC, WE HAVE 583 00:24:02,320 --> 00:24:06,360 AROUND THE GLOBE PEOPLE THAT ARE 584 00:24:06,360 --> 00:24:08,000 LIVING WITH MULTIPLE VIRUSES, 585 00:24:08,000 --> 00:24:09,440 INCLUDING HEPATITIS B, HEPATITIS 586 00:24:09,440 --> 00:24:13,920 C AND HIV. 587 00:24:13,920 --> 00:24:15,240 IT WOULD BE REALLY GOOD TO HAVE 588 00:24:15,240 --> 00:24:16,960 A PATIENT-ADMINISTERED 589 00:24:16,960 --> 00:24:18,800 DIAGNOSTIC ALLOWING FOR THE 590 00:24:18,800 --> 00:24:22,800 DETECTION OF THESE THREE VIRUSES 591 00:24:22,800 --> 00:24:23,680 SIMULTANEOUSLY. 592 00:24:23,680 --> 00:24:25,000 I THINK THIS WOULD BE A 593 00:24:25,000 --> 00:24:27,280 POTENTIAL GAME CHANGER FOR THE 594 00:24:27,280 --> 00:24:28,240 WORLD, AND SOMETHING THAT WE 595 00:24:28,240 --> 00:24:31,800 WOULD LIKE TO SPEND SOME TIME 596 00:24:31,800 --> 00:24:36,400 AND ENERGY FOSTERING. 597 00:24:36,400 --> 00:24:38,280 AND REALLY AT THE END OF THE 598 00:24:38,280 --> 00:24:40,760 DAY, IT IS ABOUT DEMONSTRATING 599 00:24:40,760 --> 00:24:42,520 THE CLINICAL SENSITIVITY AND 600 00:24:42,520 --> 00:24:45,040 SPECIFICITY OF SUCH A DEVICE FOR 601 00:24:45,040 --> 00:24:46,320 SELF-COLLECTED SPECIMENS. 602 00:24:46,320 --> 00:24:48,320 WE WANT THERE TO BE A MARKET 603 00:24:48,320 --> 00:24:50,360 ASSESSMENT AND COST-EFFECTIVE 604 00:24:50,360 --> 00:24:53,760 ANALYSIS AND DEVELOP THE TESTING 605 00:24:53,760 --> 00:24:55,560 WORK FOR SPECIFIC PRODUCT 606 00:24:55,560 --> 00:24:59,600 INDICATION. 607 00:24:59,600 --> 00:25:00,880 SO THAT'S MY PRESENTATION. 608 00:25:00,880 --> 00:25:03,840 WHILE YOU'RE CASTING YOUR VOTES, 609 00:25:03,840 --> 00:25:05,120 KEN, WHY DON'T WE OPEN THE FLOOR 610 00:25:05,120 --> 00:25:09,240 TO QUESTIONS COVERING MY TALK. 611 00:25:09,240 --> 00:25:11,360 >>YES, THANK YOU, 612 00:25:11,360 --> 00:25:12,480 DR. DIEFFENBACH, AND PLEASE, 613 00:25:12,480 --> 00:25:13,320 EVERYONE ON THE COMMITTEE, IF 614 00:25:13,320 --> 00:25:17,040 YOU COULD OPEN YOUR ECB, GO TO 615 00:25:17,040 --> 00:25:19,400 THE DAY'S ARAC TAB DOWN ABOUT A 616 00:25:19,400 --> 00:25:21,240 THIRD OF THE WAY TO THE VOTING 617 00:25:21,240 --> 00:25:22,880 MATERIALS OPEN SESSION, AND 618 00:25:22,880 --> 00:25:24,520 THOSE FOUR TOPICS ARE THERE. 619 00:25:24,520 --> 00:25:26,480 CERTAINLY WOULD BE EXCITING TO 620 00:25:26,480 --> 00:25:27,720 BE ON THE OTHER SIDE OF THESE 621 00:25:27,720 --> 00:25:32,760 AND HAVE THOSE DEVELOPED. 622 00:25:32,760 --> 00:25:34,080 QUESTIONS FOR CARL OR COMMENTS 623 00:25:34,080 --> 00:25:40,800 ON THESE TOPICS OR OTHERS? 624 00:25:40,800 --> 00:25:45,520 >>CARL, I HAD A QUESTION ABOUT 625 00:25:45,520 --> 00:25:46,960 THE LONG-ACTING -- OR THE 626 00:25:46,960 --> 00:25:50,680 DELIVERY OF THE BNABs. 627 00:25:50,680 --> 00:25:52,120 YOU SAID FOR HIV BUT I THOUGHT 628 00:25:52,120 --> 00:25:53,320 YOU ALSO SAID THERE'S SOME 629 00:25:53,320 --> 00:25:55,000 RELEVANCE TO OTHER VIRUSES, SO 630 00:25:55,000 --> 00:25:55,800 EXPLAIN THAT TO ME. 631 00:25:55,800 --> 00:25:56,960 ARE YOU -- 632 00:25:56,960 --> 00:25:58,560 >>SO I'M SAYING -- THAT'S A 633 00:25:58,560 --> 00:25:58,960 GOOD POINT. 634 00:25:58,960 --> 00:26:00,160 SO BECAUSE THIS IS THE DIVISION 635 00:26:00,160 --> 00:26:03,280 OF AIDS, OUR FOCUS IS ON 636 00:26:03,280 --> 00:26:04,600 BNABs, BUT ANYTHING WE LEARN 637 00:26:04,600 --> 00:26:06,880 IN THIS SPACE WILL BE APPLICABLE 638 00:26:06,880 --> 00:26:08,400 FOR OTHER INFECTIOUS DISEASES. 639 00:26:08,400 --> 00:26:09,760 THAT WAS MY POINT. 640 00:26:09,760 --> 00:26:10,200 >>OKAY. 641 00:26:10,200 --> 00:26:20,360 THANK YOU. 642 00:26:21,840 --> 00:26:23,240 >>I HAVE A QUICK QUESTION, 643 00:26:23,240 --> 00:26:24,360 CARL. 644 00:26:24,360 --> 00:26:26,920 VERY EXCITING IDEA OF A SINGLE 645 00:26:26,920 --> 00:26:31,080 TEST OR PLATFORM FOR HIV, HBV 646 00:26:31,080 --> 00:26:32,160 AND HCV. 647 00:26:32,160 --> 00:26:35,640 MOST OF THE VALUE OF A TEST IS 648 00:26:35,640 --> 00:26:37,480 POTENTIALLY FOR TREATMENT OF 649 00:26:37,480 --> 00:26:39,600 THOSE ILLNESSES, ALTHOUGH 650 00:26:39,600 --> 00:26:42,000 PREVENTION COULD BE ALSO 651 00:26:42,000 --> 00:26:43,760 NOTABLE. 652 00:26:43,760 --> 00:26:46,360 SO I GUESS I'M WONDERING ABOUT 653 00:26:46,360 --> 00:26:48,040 PEPFAR AND OTHER ORGANIZATIONS 654 00:26:48,040 --> 00:26:50,840 WITH A COMMITMENT TO TREAT HBV 655 00:26:50,840 --> 00:26:53,600 AND HCV, WHERE WE'VE REALLY HAD 656 00:26:53,600 --> 00:26:56,520 A FOCUS ON HIV. 657 00:26:56,520 --> 00:26:59,600 SO HAS THAT BEEN CONSIDERED IN 658 00:26:59,600 --> 00:27:00,800 TERMS OF THE DOWNSTREAM IMPACT 659 00:27:00,800 --> 00:27:03,320 OF HAVING THIS TEST AVAILABLE? 660 00:27:03,320 --> 00:27:06,600 >>WELL, AGAIN, YOU'RE THINKING 661 00:27:06,600 --> 00:27:07,960 IN VERY SIMILAR WAYS THAT WE 662 00:27:07,960 --> 00:27:08,760 HAVE BEEN THINKING. 663 00:27:08,760 --> 00:27:11,080 WE ALREADY KNOW WE HAVE GOOD 664 00:27:11,080 --> 00:27:12,760 TREATMENT FOR HEP C. 665 00:27:12,760 --> 00:27:14,520 WE ARE VERY EXCITED BY WHAT WE 666 00:27:14,520 --> 00:27:16,560 SEE IN THE HBV DRUG DEVELOPMENT 667 00:27:16,560 --> 00:27:19,040 AND TREATMENT STRATEGIES, AND SO 668 00:27:19,040 --> 00:27:22,840 WHAT TO HELP BE A DISRUPTIVE 669 00:27:22,840 --> 00:27:24,720 INNOVATION, TO HELP BRING THESE 670 00:27:24,720 --> 00:27:26,600 MEDICATIONS ALONG, THAN A SIMPLE 671 00:27:26,600 --> 00:27:28,000 TEST THAT COULD BE USED 672 00:27:28,000 --> 00:27:29,640 CLINICALLY. 673 00:27:29,640 --> 00:27:31,400 SO THERE IS SOME METHOD TO OUR 674 00:27:31,400 --> 00:27:33,160 MADNESS. 675 00:27:33,160 --> 00:27:34,120 SO THANK YOU. 676 00:27:34,120 --> 00:27:34,920 >>GREAT. 677 00:27:34,920 --> 00:27:35,320 GREAT. 678 00:27:35,320 --> 00:27:38,960 MONICA. 679 00:27:38,960 --> 00:27:42,000 >>I RECOGNIZE THIS IS DAIDS, 680 00:27:42,000 --> 00:27:45,080 BUT IT IS EXCITING, MONOCLONAL 681 00:27:45,080 --> 00:27:47,920 ANTIBODIES ARE IMPORTANT, 682 00:27:47,920 --> 00:27:50,880 BNABs ARE IMPORTANT, BUT THE 683 00:27:50,880 --> 00:27:53,640 EVUSHELD FOR SARS-COV-2 684 00:27:53,640 --> 00:27:54,840 PROPHYLAXIS JUST GOT TAKEN OFF 685 00:27:54,840 --> 00:27:56,800 THE FDA LIST LAST WEEK BECAUSE 686 00:27:56,800 --> 00:27:59,000 OF THE EMERGENCE OF THESE NEW 687 00:27:59,000 --> 00:28:00,400 VARIANTS AND SUBVARIANTS, AND WE 688 00:28:00,400 --> 00:28:02,360 ACTUALLY HAVE NO MONOCLONAL 689 00:28:02,360 --> 00:28:03,680 ANTIBODIES NOW TO TREAT OR 690 00:28:03,680 --> 00:28:06,280 PREVENT SARS-COV-2. 691 00:28:06,280 --> 00:28:08,520 >>SOTROVIMAB IS COMING BACK 692 00:28:08,520 --> 00:28:08,720 SOON. 693 00:28:08,720 --> 00:28:09,800 >>OKAY. 694 00:28:09,800 --> 00:28:10,480 REALLY. 695 00:28:10,480 --> 00:28:10,920 OKAY. 696 00:28:10,920 --> 00:28:13,800 THAT IS MY QUESTION, IS THAT CAN 697 00:28:13,800 --> 00:28:15,280 WE -- DESPITE THE PANDEMIC 698 00:28:15,280 --> 00:28:16,800 PREPAREDNESS AND ALL THAT NOT 699 00:28:16,800 --> 00:28:19,800 BEING ADEQUATELY FUNDED, CAN WE 700 00:28:19,800 --> 00:28:22,920 CONTINUE TO SUPPORT AND WORK ON 701 00:28:22,920 --> 00:28:24,080 MONOCLONAL ANTIBODIES FOR ALL 702 00:28:24,080 --> 00:28:25,840 INFECTIOUS DISEASES INCLUDING 703 00:28:25,840 --> 00:28:26,160 SARS-COV-2? 704 00:28:26,160 --> 00:28:30,000 >>THAT'S A QUESTION THAT GOES 705 00:28:30,000 --> 00:28:31,360 TO IN THE DMID SESSION, IF YOU 706 00:28:31,360 --> 00:28:32,280 WERE SITTING OVER THERE 707 00:28:32,280 --> 00:28:33,600 LISTENING TO EMILY'S GROUP, YOU 708 00:28:33,600 --> 00:28:34,880 WILL HEAR THAT THEY ARE 709 00:28:34,880 --> 00:28:38,440 INTERESTED IN SUPPORTING 710 00:28:38,440 --> 00:28:40,400 MONOCLONAL ANTIBODY DEVELOPMENT 711 00:28:40,400 --> 00:28:41,520 FOR DISEASES IN THE FUTURE. 712 00:28:41,520 --> 00:28:45,480 THE VRC HAS BEEN COMMITTED TO 713 00:28:45,480 --> 00:28:49,040 THIS AS WELL, DEVELOPING A 714 00:28:49,040 --> 00:28:52,360 MALARIA MONOCLONAL AND ALSO 715 00:28:52,360 --> 00:28:53,760 MONOCLONALS FOR VIRUSES LIKE 716 00:28:53,760 --> 00:28:55,960 EBOLA AND MARBURG, THINGS LIKE 717 00:28:55,960 --> 00:28:56,280 THAT. 718 00:28:56,280 --> 00:28:58,040 SO I THINK THE INSTITUTE IS 719 00:28:58,040 --> 00:28:59,440 COMMITTED TO MONOCLONAL 720 00:28:59,440 --> 00:29:01,120 ANTIBODIES AS WELL. 721 00:29:01,120 --> 00:29:02,880 >>WE'LL TAKE ONE MORE QUESTION. 722 00:29:02,880 --> 00:29:05,640 KEITH. 723 00:29:05,640 --> 00:29:07,760 >>CARL, FOR SUBJECTS THREE AND 724 00:29:07,760 --> 00:29:10,920 FOUR, THE SBIR, THE PATIENT 725 00:29:10,920 --> 00:29:11,600 ADMINISTERED DIAGNOSTIC HAS 726 00:29:11,600 --> 00:29:12,840 OBVIOUSLY BEEN CRITICAL AND VERY 727 00:29:12,840 --> 00:29:13,800 SUCCESSFUL IN THE COVID 728 00:29:13,800 --> 00:29:14,720 RESPONSE, BUT THE FLIP SIDE IS 729 00:29:14,720 --> 00:29:16,400 OF COURSE WE HAVE NO IDEA HOW 730 00:29:16,400 --> 00:29:17,400 MANY INFECTIONS THERE REALLY 731 00:29:17,400 --> 00:29:18,320 ARE. 732 00:29:18,320 --> 00:29:19,800 SO IS THAT REPORTING ISSUE SORT 733 00:29:19,800 --> 00:29:22,880 OF PART OF WHAT YOU'RE THINKING 734 00:29:22,880 --> 00:29:23,640 ABOUT HERE IN THAT? 735 00:29:23,640 --> 00:29:25,720 IN OTHER WORDS, ARE THESE JUST 736 00:29:25,720 --> 00:29:27,600 REALLY JUST -- YOU KNOW, IDEALLY 737 00:29:27,600 --> 00:29:29,360 AN LFA WHERE YOU THROW IT AWAY 738 00:29:29,360 --> 00:29:31,120 WHEN YOU'RE DONE, OR ARE THESE 739 00:29:31,120 --> 00:29:31,880 SOMETHING WHERE YOU'RE HOPING 740 00:29:31,880 --> 00:29:33,280 THAT THERE WILL BE SOME SORT OF 741 00:29:33,280 --> 00:29:36,880 REPORTING OR CONNECTION WITH THE 742 00:29:36,880 --> 00:29:38,320 HEALTHCARE SYSTEM? 743 00:29:38,320 --> 00:29:40,080 >>THAT NEEDS TO BE WORKED OUT. 744 00:29:40,080 --> 00:29:42,280 THE GOOD THING IS CORONAVIRUS DO 745 00:29:42,280 --> 00:29:44,360 HAVE THESE OTHER CIRCUIT MARKERS 746 00:29:44,360 --> 00:29:45,480 CALLED HOSPITALIZATIONS AND 747 00:29:45,480 --> 00:29:48,720 DEATHS. 748 00:29:48,720 --> 00:29:51,160 WE KNOW -- I REALIZE THEY'RE LAG 749 00:29:51,160 --> 00:29:52,240 INDICATORS BUT IT'S NOT LIKE 750 00:29:52,240 --> 00:29:53,120 WE'RE COMPLETELY IN THE DARK. 751 00:29:53,120 --> 00:29:54,640 >>YEAH, BUT -- ALL RIGHT, THE 752 00:29:54,640 --> 00:29:55,960 CURE TRIAL, THAT'S NOT GOING 753 00:29:55,960 --> 00:29:56,840 TO -- YOU KNOW, RIGHT? 754 00:29:56,840 --> 00:29:58,760 >>EXACTLY. 755 00:29:58,760 --> 00:30:00,560 >>YOU MISS PEOPLE THAT COME IN 756 00:30:00,560 --> 00:30:01,080 WITH HIV. 757 00:30:01,080 --> 00:30:03,440 >>I THINK YOUR POINT IS FOR THE 758 00:30:03,440 --> 00:30:05,400 SELF-TESTING FOR HIV, YOU WOULD 759 00:30:05,400 --> 00:30:09,200 IDEALLY WANT THERE TO BE A 760 00:30:09,200 --> 00:30:10,480 HEALTHCARE SYSTEM BUILT AROUND 761 00:30:10,480 --> 00:30:12,160 THAT CURE PATIENT THAT IF THEY 762 00:30:12,160 --> 00:30:15,680 DID TEST POSITIVE, THEY HAD A 763 00:30:15,680 --> 00:30:17,000 1-800 NUMBER OR WAY OF REACHING 764 00:30:17,000 --> 00:30:20,920 OUT IMMEDIATELY TO REINITIATE 765 00:30:20,920 --> 00:30:22,680 THERAPY, GO IN AND GET A BLOOD 766 00:30:22,680 --> 00:30:24,680 TEST, ALL OF THAT, SO YOU GOT A 767 00:30:24,680 --> 00:30:24,880 SENSE. 768 00:30:24,880 --> 00:30:26,920 BUT I THINK THAT HAS TO BE BUILT 769 00:30:26,920 --> 00:30:28,160 INTO THE SYSTEM FOR THOSE KINDS 770 00:30:28,160 --> 00:30:30,640 OF TISES. 771 00:30:30,640 --> 00:30:31,120 OF TESTS. 772 00:30:31,120 --> 00:30:32,040 >>GREAT. 773 00:30:32,040 --> 00:30:33,200 THANK YOU, DR. DIEFFENBACH. 774 00:30:33,200 --> 00:30:35,800 WE WILL TURN NOW TO DR. MAUREEN 775 00:30:35,800 --> 00:30:36,640 GOODENOW, DIRECTOR OF THE OFFICE 776 00:30:36,640 --> 00:30:40,400 OF AIDS RESEARCH, FOR THE OFFICE 777 00:30:40,400 --> 00:30:41,920 OF AIDS RESEARCH REPORT. 778 00:30:41,920 --> 00:30:45,120 THANK YOU, DR. GOODENOW. 779 00:30:45,120 --> 00:30:47,120 >>WELL, THANK YOU VERY MUCH. 780 00:30:47,120 --> 00:30:52,520 LET ME JUST GET MY MATERIALS UP 781 00:30:52,520 --> 00:30:54,520 HERE. 782 00:30:54,520 --> 00:30:57,840 I'M ASSUMING YOU CAN HEAR ME. 783 00:30:57,840 --> 00:30:58,920 >>WE CAN. 784 00:30:58,920 --> 00:31:00,360 YES. 785 00:31:00,360 --> 00:31:01,960 >>OKAY. 786 00:31:01,960 --> 00:31:02,520 WELL, THANK YOU. 787 00:31:02,520 --> 00:31:04,240 I'M VERY HAPPY TO BE HERE TODAY 788 00:31:04,240 --> 00:31:06,400 TO PROVIDE AN OVERVIEW OF THE 789 00:31:06,400 --> 00:31:08,080 NEW AND EXCITING INITIATIVES AT 790 00:31:08,080 --> 00:31:11,600 THE OFFICE OF AIDS RESEARCH. 791 00:31:11,600 --> 00:31:13,240 OAR WAS ESTABLISHED 35 YEARS AGO 792 00:31:13,240 --> 00:31:15,320 WITH THE LEGISLATIVE MANDATE TO 793 00:31:15,320 --> 00:31:18,280 CONVENE PARTNERS ACROSS NIH 794 00:31:18,280 --> 00:31:19,720 INSTITUTES, CENTERS AND OFFICES, 795 00:31:19,720 --> 00:31:21,880 FEDERAL AGENCIES AND COMMUNITY 796 00:31:21,880 --> 00:31:24,320 GROUPS FOR A ROBUST AGENDA IN 797 00:31:24,320 --> 00:31:25,520 HIV RESEARCH. 798 00:31:25,520 --> 00:31:27,800 THE GOAL WAS AND CONTINUES TO BE 799 00:31:27,800 --> 00:31:32,840 TO END THE HIV PANDEMIC. 800 00:31:32,840 --> 00:31:33,600 THE NEXT SLIDE. 801 00:31:33,600 --> 00:31:36,000 OVER THE PAST 40 YEARS, OUR WORK 802 00:31:36,000 --> 00:31:38,120 ADDRESSING THE HIV PANDEMIC HAS 803 00:31:38,120 --> 00:31:40,960 EVOLVED IN SIGNIFICANT WAYS. 804 00:31:40,960 --> 00:31:43,360 THE INITIAL RESEARCH FOCUS ON 805 00:31:43,360 --> 00:31:45,440 HIV PATHOGENESIS EXPANDED 806 00:31:45,440 --> 00:31:47,200 TOWARDS HIV DIAGNOSIS, 807 00:31:47,200 --> 00:31:49,280 TREATMENT, PREVENTION, CURE, AND 808 00:31:49,280 --> 00:31:50,920 IMPROVING THE HEALTH OF PEOPLE 809 00:31:50,920 --> 00:31:56,080 WITH HIV. 810 00:31:56,080 --> 00:31:57,520 CRITICAL TO ACCOMPLISHING THE 811 00:31:57,520 --> 00:31:59,480 OAR MISSION IS TO UNDERSTAND THE 812 00:31:59,480 --> 00:32:02,200 PERSPECTIVES OF PEOPLE WITH HIV. 813 00:32:02,200 --> 00:32:04,480 OAR LISTEN NG SESSIONS WITH 814 00:32:04,480 --> 00:32:06,040 COMMUNITY PARTNERS PROVIDE DATA 815 00:32:06,040 --> 00:32:09,640 WE USE TO ENSURE THAT THE NIH 816 00:32:09,640 --> 00:32:13,360 HIV RESEARCH PROGRAM IS 817 00:32:13,360 --> 00:32:14,240 FLEXIBLE, AND RESEARCH 818 00:32:14,240 --> 00:32:15,680 PRIORITIES ARE RESPONSIVE TO 819 00:32:15,680 --> 00:32:18,840 EMERGING CHALLENGES AND 820 00:32:18,840 --> 00:32:19,040 NEEDS. 821 00:32:19,040 --> 00:32:20,680 IN THE NEXT SLIDE, LISTENING 822 00:32:20,680 --> 00:32:22,800 SESSION WITH FEDERAL, ACADEMIC 823 00:32:22,800 --> 00:32:24,880 AND COMMUNITY PARTNERS CONTINUE 824 00:32:24,880 --> 00:32:26,800 TO GUIDE OAR FOCUS ON SPECIFIC 825 00:32:26,800 --> 00:32:29,560 AREAS OF INTEREST, TIED TO THE 826 00:32:29,560 --> 00:32:35,040 NIH HIV RESEARCH COMMISSION, ANE 827 00:32:35,040 --> 00:32:37,240 CURRENT PRIORITIES FOR HIV AND 828 00:32:37,240 --> 00:32:38,200 HIV RELATED RESEARCH. 829 00:32:38,200 --> 00:32:39,920 WE CALL THESE AREAS OF INTEREST 830 00:32:39,920 --> 00:32:40,600 SIGNATURE PROGRAMS. 831 00:32:40,600 --> 00:32:42,360 THESE ARE MULTIDISCIPLINARY, 832 00:32:42,360 --> 00:32:44,120 SUPPORTED BY MULTIPLE NIH 833 00:32:44,120 --> 00:32:45,680 INSTITUTES, CENTERS AND OFFICES, 834 00:32:45,680 --> 00:32:48,160 AND INCLUDES SPECIFICALLY PEOPLE 835 00:32:48,160 --> 00:32:51,880 AGING WITH HIV, HIV AND WOMEN'S 836 00:32:51,880 --> 00:32:53,520 HEALTH, TECHNOLOGY ADVANCES FOR 837 00:32:53,520 --> 00:32:56,080 HIV RESEARCH, AND SUPPORT FOR 838 00:32:56,080 --> 00:32:57,920 EARLY CAREER INVESTIGATORS IN 839 00:32:57,920 --> 00:33:00,520 HIV RESEARCH. 840 00:33:00,520 --> 00:33:02,280 I'M GOING TO BRIEFLY EXPLAIN OR 841 00:33:02,280 --> 00:33:04,920 DESCRIBE EACH OF THESE PROGRAMS 842 00:33:04,920 --> 00:33:06,960 STARTING WITH HIV AND AGING IN 843 00:33:06,960 --> 00:33:11,160 THE NEXT SLIDE. 844 00:33:11,160 --> 00:33:13,320 40 YEARS INTO THE PANDEMIC, 845 00:33:13,320 --> 00:33:14,760 PEOPLE WITH HIV CAN NOW ACHIEVE 846 00:33:14,760 --> 00:33:16,200 A NEARLY NORMAL LIFESPAN BECAUSE 847 00:33:16,200 --> 00:33:18,480 OF HIGHLY EFFECTIVE 848 00:33:18,480 --> 00:33:20,040 ANTIRETROVIRAL THERAPIES. 849 00:33:20,040 --> 00:33:22,640 ONE OF THE OUTCOMES OF THIS 850 00:33:22,640 --> 00:33:24,440 SUCCESS IS THAT MORE THAN HALF 851 00:33:24,440 --> 00:33:26,920 OF THE APPROXIMATELY 1.2 MILLION 852 00:33:26,920 --> 00:33:30,440 PEOPLE WITH HIV IN THE UNITED 853 00:33:30,440 --> 00:33:34,880 STATES ARE 50 YEARS OR OLDER. 854 00:33:34,880 --> 00:33:36,480 THIS AGE GROUP HAS BEEN STEADILY 855 00:33:36,480 --> 00:33:37,720 INCREASING AT ABOUT 5% PER YEAR 856 00:33:37,720 --> 00:33:40,400 FOR THE LAST THREE YEARS. 857 00:33:40,400 --> 00:33:42,000 VERSUS STABLE NUMBERS IN THE 858 00:33:42,000 --> 00:33:44,120 YOUNGER AGE GROUPS. 859 00:33:44,120 --> 00:33:49,040 IN 2020, IN ADDITION, ABOUT 17% 860 00:33:49,040 --> 00:33:51,240 OF NEW INFECTIONS OCCURRED IN 861 00:33:51,240 --> 00:33:58,240 PERSONS OLDER THAN AGE 50. 862 00:33:58,240 --> 00:34:00,240 OLDER PEOPLE WITH HIV EXPERIENCE 863 00:34:00,240 --> 00:34:01,520 AGE-RELATED COMPLICATIONS 864 00:34:01,520 --> 00:34:02,520 INCLUDING NEUROCOGNITIVE 865 00:34:02,520 --> 00:34:03,840 IMPAIRMENT, BONE AND MUSCLE 866 00:34:03,840 --> 00:34:06,240 DISORDERS, AND CARDIOVASCULAR 867 00:34:06,240 --> 00:34:07,080 DISEASE. 868 00:34:07,080 --> 00:34:08,880 IN PARALLEL, PEOPLE AGING WITH 869 00:34:08,880 --> 00:34:10,720 HIV FACE MULTIPLE SOCIAL AND 870 00:34:10,720 --> 00:34:13,480 BEHAVIORAL CONCERNS, SUCH AS 871 00:34:13,480 --> 00:34:15,440 INTERSECTIONAL STIGMA, SOCIAL 872 00:34:15,440 --> 00:34:20,680 ISOLATION, AND MENTAL HEALTH 873 00:34:20,680 --> 00:34:21,800 CONDITIONS. 874 00:34:21,800 --> 00:34:22,480 OTHER SIGNIFICANT CHALLENGES IN 875 00:34:22,480 --> 00:34:23,760 THIS POPULATION INCLUDE 876 00:34:23,760 --> 00:34:24,760 POLYPHARMACY, INCREASED 877 00:34:24,760 --> 00:34:25,720 CAREGIVER BURDEN AND COMPLEX 878 00:34:25,720 --> 00:34:29,480 SUPPORT SERVICES. 879 00:34:29,480 --> 00:34:32,040 IN THE NEXT SLIDE, A TOTAL OF 17 880 00:34:32,040 --> 00:34:33,400 INSTITUTES, CENTERS AND OFFICES 881 00:34:33,400 --> 00:34:36,480 SUPPORT THE MULTIFACETED HIV AND 882 00:34:36,480 --> 00:34:37,320 AGING PORTFOLIO. 883 00:34:37,320 --> 00:34:38,760 WITH ESTIMATED FUNDING FOR HIV 884 00:34:38,760 --> 00:34:41,920 AND AGING RESEARCH IN FISCAL 885 00:34:41,920 --> 00:34:46,000 YEAR 2022 OF ABOUT $119 MILLION. 886 00:34:46,000 --> 00:34:48,320 THE NATIONAL INSTITUTE ON AGING, 887 00:34:48,320 --> 00:34:49,720 NIA, CONTRIBUTES TO 888 00:34:49,720 --> 00:34:53,440 APPROXIMATELY TAPPE 25% OF THIS 889 00:34:53,440 --> 00:34:54,880 PORTFOLIO, NEARLY TRIPLE ITS 890 00:34:54,880 --> 00:34:56,160 INVESTMENT SINCE 2017. 891 00:34:56,160 --> 00:34:57,120 HEART, LUNG AND BLOOD, THE 892 00:34:57,120 --> 00:35:00,280 OFFICE OF THE DIRECTOR, AND THE 893 00:35:00,280 --> 00:35:01,800 NATIONAL INSTITUTES ON MENTAL 894 00:35:01,800 --> 00:35:03,880 HEALTH ACCOUNT FOR ABOUT 40% OF 895 00:35:03,880 --> 00:35:07,320 THE PORTFOLIO, WITH NIDA, NIAID, 896 00:35:07,320 --> 00:35:10,280 NINDS, NIAA AND NCI AT ABOUT 897 00:35:10,280 --> 00:35:10,480 25%. 898 00:35:10,480 --> 00:35:11,800 WITH THE GROWING NUMBER OF 899 00:35:11,800 --> 00:35:13,760 PEOPLE AGING WITH HIV, WE 900 00:35:13,760 --> 00:35:14,960 ANTICIPATE THE NEED FOR GREATER 901 00:35:14,960 --> 00:35:19,480 SUPPORT IN THE FUTURE. 902 00:35:19,480 --> 00:35:21,560 SO THE HIV AND AGING SIGNATURE 903 00:35:21,560 --> 00:35:23,520 PROGRAM AIMS TO CATALYZE 904 00:35:23,520 --> 00:35:26,920 COLLABORATIONS TO ADDRESS 905 00:35:26,920 --> 00:35:27,920 RESEARCH GAPS IN OPPORTUNITIES 906 00:35:27,920 --> 00:35:31,320 AT THE INTERSECTION OF HIV AND 907 00:35:31,320 --> 00:35:32,480 AGING. 908 00:35:32,480 --> 00:35:34,720 OAR HAS PARTNERED WITH NIA TO 909 00:35:34,720 --> 00:35:41,520 FORM THE NIH HIV WORKING GROUP. 910 00:35:41,520 --> 00:35:42,760 THIS GROUP AIMS TO LINK 911 00:35:42,760 --> 00:35:44,080 STRATEGIC PARTNERS ACROSS 912 00:35:44,080 --> 00:35:46,040 GOVERNMENT AGENCIES, ACADEMIA 913 00:35:46,040 --> 00:35:48,720 AND COMMUNITY ORGANIZATIONS TO 914 00:35:48,720 --> 00:35:50,280 ENSURE THAT NIH RESEARCH IS 915 00:35:50,280 --> 00:35:54,320 ALIGNED WITH COMMUNITY NEEDS AND 916 00:35:54,320 --> 00:35:56,680 CULTURAL PREFERENCES. 917 00:35:56,680 --> 00:35:59,160 IN THE NEXT SLIDE, A SECOND 918 00:35:59,160 --> 00:36:01,320 SIGNATURE PROGRAM FOCUSED ON HIV 919 00:36:01,320 --> 00:36:02,960 AND AGING. 920 00:36:02,960 --> 00:36:04,160 GLOBALLY, WOMEN AND GIRLS 921 00:36:04,160 --> 00:36:06,440 ACCOUNT FOR 49% OF ALL NEW 922 00:36:06,440 --> 00:36:12,040 INFENGINFECTIONS IN 2021. 923 00:36:12,040 --> 00:36:13,360 APPROXIMATELY 20 MILLION WOMEN 924 00:36:13,360 --> 00:36:14,120 WORLDWIDE ARE HIV-POSITIVE, 925 00:36:14,120 --> 00:36:17,280 WHICH IS ABOUT 54% OF THE GLOBAL 926 00:36:17,280 --> 00:36:20,520 PREVALENCE. 927 00:36:20,520 --> 00:36:23,640 IN SUB-SAHARAN AFRICA, YOUNG ADD 928 00:36:23,640 --> 00:36:26,800 RE SENT GIRLS AND YOUNG WOMEN 929 00:36:26,800 --> 00:36:28,800 ARE TWICE AS LIKELY TO HAVE HIV 930 00:36:28,800 --> 00:36:30,400 THAN THEIR PEERS. 931 00:36:30,400 --> 00:36:32,040 AMONG TRANSGENDER WOMEN, THERE'S 932 00:36:32,040 --> 00:36:33,920 A 14 FOLD GREATER RISK OF 933 00:36:33,920 --> 00:36:35,000 ACQUIRING HIV COMPARED TO 934 00:36:35,000 --> 00:36:37,000 CISGENDER WOMEN, AND GLOBALLY, 935 00:36:37,000 --> 00:36:39,600 THE PREVALENCE OF HIV AMONG 936 00:36:39,600 --> 00:36:41,040 TRANSGENDER WOMEN IS 937 00:36:41,040 --> 00:36:43,480 APPROXIMATELY 20%. 938 00:36:43,480 --> 00:36:45,520 IN THE NEXT SLIDE, A 939 00:36:45,520 --> 00:36:46,840 MULTIDISCIPLINARY APPROACH IS 940 00:36:46,840 --> 00:36:48,960 CRUCIAL TO IMPROVE THE HEALTH OF 941 00:36:48,960 --> 00:36:53,000 WOMEN WITH HIV, AND THIS 942 00:36:53,000 --> 00:36:54,640 APPROACH IS REFLECTED IN THE NIH 943 00:36:54,640 --> 00:36:56,840 HIV AND WOMEN'S HEALTH RESEARCH 944 00:36:56,840 --> 00:36:57,280 PORTFOLIO. 945 00:36:57,280 --> 00:37:00,280 THERE'S INVESTMENT BY 19 OF THE 946 00:37:00,280 --> 00:37:03,120 27 INSTITUTES AND CENTERS IN A 947 00:37:03,120 --> 00:37:05,160 WIDE RANGE OF RESEARCH TOPICS ON 948 00:37:05,160 --> 00:37:07,240 HIV AND WOMEN, WITH ABOUT TWO 949 00:37:07,240 --> 00:37:10,720 THIRDS OF THE PORTFOLIO FROM 950 00:37:10,720 --> 00:37:13,400 NIAID AND NICHD. 951 00:37:13,400 --> 00:37:15,160 BUT COLLABORATIONS ACROSS THE 952 00:37:15,160 --> 00:37:17,120 ICs, THE OAR AND THE OFFICE OF 953 00:37:17,120 --> 00:37:20,960 RESEARCH ON WOMEN'S HEALTH, 954 00:37:20,960 --> 00:37:22,640 ORWH, FOR CROSS-CUTTING RESEARCH 955 00:37:22,640 --> 00:37:27,200 AND THERAPIES FOR HIV-ASSOCIATED 956 00:37:27,200 --> 00:37:31,920 COMORBIDITIES AND COINFORECASTS. 957 00:37:31,920 --> 00:37:33,000 OAR'S SIGNATURE PROGRAM ON HIV 958 00:37:33,000 --> 00:37:35,880 AND WOMEN IN PARTNERSHIP WITH 959 00:37:35,880 --> 00:37:37,800 ORWH AIMS TO PROMOTE THE NIH 960 00:37:37,800 --> 00:37:40,160 VISION FOR WOMEN'S HEALTH WHERE 961 00:37:40,160 --> 00:37:42,840 ALL WOMEN, INCLUDING TRANSGENDER 962 00:37:42,840 --> 00:37:44,720 WOMEN AND INDIVIDUALS ASSIGNED 963 00:37:44,720 --> 00:37:49,000 FEMALE AT BIRTH RECEIVED 964 00:37:49,000 --> 00:37:50,440 EVIDENCE-BASED, 965 00:37:50,440 --> 00:37:52,400 GENDER-AFFIRMING, TAILORED HIV 966 00:37:52,400 --> 00:37:54,040 PREVENTION, CARE AND TREATMENT. 967 00:37:54,040 --> 00:37:56,000 THIS PROGRAM ALSO SUPPORTS WOMEN 968 00:37:56,000 --> 00:37:57,720 IN SCIENCE CAREERS TO REACH 969 00:37:57,720 --> 00:38:02,280 THEIR FULL POTENTIAL. 970 00:38:02,280 --> 00:38:03,400 OAR AND THE OFFICE OF RESEARCH 971 00:38:03,400 --> 00:38:05,200 ON WOMEN'S HEALTH RECENTLY 972 00:38:05,200 --> 00:38:07,920 LAUNCHED AN NIH HIV AND WOMEN 973 00:38:07,920 --> 00:38:10,440 WORKING GROUP TO IDENTIFY GAPS 974 00:38:10,440 --> 00:38:10,920 AND PRIORITIES AT THE 975 00:38:10,920 --> 00:38:12,200 INTERSECTION OF WOMEN'S HEALTH 976 00:38:12,200 --> 00:38:14,520 AND HIV. 977 00:38:14,520 --> 00:38:16,160 AND THERE WILL BE A JOINT 978 00:38:16,160 --> 00:38:18,480 SYMPOSIUM AT THE 13TH 979 00:38:18,480 --> 00:38:20,400 INTERNATIONAL WORKSHOP ON WOMEN 980 00:38:20,400 --> 00:38:23,400 AND HIV THAT'S SCHEDULED TO 981 00:38:23,400 --> 00:38:26,120 OCCUR JUST BEFORE -- NEXT MONTH 982 00:38:26,120 --> 00:38:26,680 IN SEATTLE. 983 00:38:26,680 --> 00:38:28,800 THIS WILL FOCUS ON ADOLESCENT 984 00:38:28,800 --> 00:38:30,440 GIRLS AND YOUNG WOMEN, 985 00:38:30,440 --> 00:38:31,640 MULTI-MORBIDITY AND AGING, AND 986 00:38:31,640 --> 00:38:32,720 SOCIAL AND STRUCTURAL 987 00:38:32,720 --> 00:38:37,240 CONSIDERATIONS IN HIV RESEARCH. 988 00:38:37,240 --> 00:38:41,160 IN THE NEXT SLIDE IS A FOCUS ON 989 00:38:41,160 --> 00:38:42,920 TECHNOLOGY FOR HIV RESEARCH, 990 00:38:42,920 --> 00:38:44,440 WHICH PICKS UP ON SOME OF THE 991 00:38:44,440 --> 00:38:46,760 THEMES THAT CARL INTRODUCED. 992 00:38:46,760 --> 00:38:48,480 BUT BEFORE I DISCUSS THE TECH 993 00:38:48,480 --> 00:38:51,040 KNOWLEDGE FOR HIV RESEARCH 994 00:38:51,040 --> 00:38:52,120 SIGNATURE PROGRAM, I'D LIKE TO 995 00:38:52,120 --> 00:38:54,320 MENTION THAT WHEN WE WERE AT THE 996 00:38:54,320 --> 00:38:55,640 AIDS 2022 CONFERENCE IN MONTREAL 997 00:38:55,640 --> 00:38:58,400 THIS PAST SUMMER, WE VISITED A 998 00:38:58,400 --> 00:39:01,040 LOCAL HIV CLINIC. 999 00:39:01,040 --> 00:39:04,840 THERE WE COULD SEE HOW PROVIDERS 1000 00:39:04,840 --> 00:39:06,080 LEVERAGE TECHNOLOGY TO ENABLE 1001 00:39:06,080 --> 00:39:07,800 CLIENTS TO SCHEDULE APPOINTMENTS 1002 00:39:07,800 --> 00:39:10,200 ONLINE, SELF-TEST ON SITE, AND 1003 00:39:10,200 --> 00:39:11,960 LEARN RESULTS VIA TELEHEALTH 1004 00:39:11,960 --> 00:39:13,160 APPOINTMENTS. 1005 00:39:13,160 --> 00:39:16,960 AND THESE INNOVATIONS ALONG WITH 1006 00:39:16,960 --> 00:39:19,160 STATUS NEUTRAL HIV AND STI 1007 00:39:19,160 --> 00:39:19,840 TESTING, PREVENTION AND 1008 00:39:19,840 --> 00:39:21,680 TREATMENT SERVICES ALL IN ONE 1009 00:39:21,680 --> 00:39:23,560 PLACE MAKE HIV CARE MORE 1010 00:39:23,560 --> 00:39:26,480 CONVENIENT AND ACCESSIBLE. 1011 00:39:26,480 --> 00:39:27,800 PROGRAMS LIKE THIS ARE CRITICAL 1012 00:39:27,800 --> 00:39:29,920 TO HIV EPIDEMIC CONTROL AND TO 1013 00:39:29,920 --> 00:39:31,320 THE PREVENTION OF NEW 1014 00:39:31,320 --> 00:39:33,200 INFECTIONS. 1015 00:39:33,200 --> 00:39:35,320 AND CURRENTLY, THERE ARE FEW 1016 00:39:35,320 --> 00:39:36,360 POINT OF CARE OPTIONS FOR VIRAL 1017 00:39:36,360 --> 00:39:38,520 LOAD MONITORING OR EVEN HIV 1018 00:39:38,520 --> 00:39:39,640 SELF-TESTING IN PART BECAUSE 1019 00:39:39,640 --> 00:39:44,280 COSTS ARE PROHIBITIVE. 1020 00:39:44,280 --> 00:39:46,120 THE TECHNOLOGY FOR HIV RESEARCH 1021 00:39:46,120 --> 00:39:47,240 SIGNATURE PROGRAM AIMS TO 1022 00:39:47,240 --> 00:39:50,520 ADVANCE RESEARCH TO DEVELOP 1023 00:39:50,520 --> 00:39:51,960 INNOVATIVE PRODUCTS SUCH AS 1024 00:39:51,960 --> 00:39:53,560 AFFORDABLE AT-HOME TESTS FOR 1025 00:39:53,560 --> 00:39:55,240 VIRAL LOAD MONITORING AND 1026 00:39:55,240 --> 00:39:55,960 INCREASED ACCESS TO 1027 00:39:55,960 --> 00:39:57,360 POINT-OF-CARE TESTING WITHIN 1028 00:39:57,360 --> 00:40:03,880 COMMUNITIES. 1029 00:40:03,880 --> 00:40:06,400 IN THE NEXT SLIDE, FOCUSING ON 1030 00:40:06,400 --> 00:40:09,480 EARLY CAREER INVESTIGATORS, 1031 00:40:09,480 --> 00:40:10,720 WHICH IS ANOTHER FREQUENT THEME 1032 00:40:10,720 --> 00:40:14,720 FROM LISTENING SESSIONS, AND AS 1033 00:40:14,720 --> 00:40:15,800 WE CAN SEE HERE IN THIS QUOTE 1034 00:40:15,800 --> 00:40:18,600 FROM THE FIRST OAR HIV 1035 00:40:18,600 --> 00:40:20,560 STAKEHOLDER ENGAGEMENT REPORT 1036 00:40:20,560 --> 00:40:21,040 FROM 2020. 1037 00:40:21,040 --> 00:40:22,000 AND I'LL JUST GIVE YOU A MINUTE 1038 00:40:22,000 --> 00:40:32,400 TO READ THAT YOURSELF. 1039 00:40:33,120 --> 00:40:34,680 IN THE NEXT SLIDE, THE FEEDBACK 1040 00:40:34,680 --> 00:40:37,000 THAT WE'VE BEEN HEARING FROM 1041 00:40:37,000 --> 00:40:39,640 LISTENING SESSIONS LED OAR TO 1042 00:40:39,640 --> 00:40:41,560 ANALYZE AND REVIEW SUPPORT FOR 1043 00:40:41,560 --> 00:40:43,640 NEXT GENERATION RESEARCHERS IN 1044 00:40:43,640 --> 00:40:47,800 THE HIV PORTFOLIO OVER TIME. 1045 00:40:47,800 --> 00:40:50,520 THE FOCUS DEVELOPED FROM AN 1046 00:40:50,520 --> 00:40:51,680 NIHIN' WIDE INITIATIVE TO 1047 00:40:51,680 --> 00:40:53,680 INCREASE THE NUMBER OF NEXT 1048 00:40:53,680 --> 00:40:57,200 GENERATION RESEARCHERS RECEIVING 1049 00:40:57,200 --> 00:40:57,840 R01 EQUIVALENTS ACROSS THE NIH 1050 00:40:57,840 --> 00:40:58,640 IN GENERAL. 1051 00:40:58,640 --> 00:41:00,960 THE GRAPH SHOWS THAT THE NUMBER 1052 00:41:00,960 --> 00:41:02,360 OF EARLY CAREER INVESTIGATORS IN 1053 00:41:02,360 --> 00:41:06,080 HIV RESEARCH, IN RED, HAS 1054 00:41:06,080 --> 00:41:07,520 INCREASED, BUT TO A LESSER 1055 00:41:07,520 --> 00:41:10,040 EXTENT AN OVERALL NIH EARLY 1056 00:41:10,040 --> 00:41:14,720 STAGE INVESTIGATORS IN BLUE. 1057 00:41:14,720 --> 00:41:15,640 OAR HAS DEVELOPED A SIGNATURE 1058 00:41:15,640 --> 00:41:16,920 PROGRAM THAT AIMS TO INCREASE 1059 00:41:16,920 --> 00:41:18,240 THE NUMBER OF EARLY STAGE 1060 00:41:18,240 --> 00:41:20,080 INVESTIGATORS IN HIV AND STABLY 1061 00:41:20,080 --> 00:41:23,400 SUPPORT THE NEXT GENERATION OF 1062 00:41:23,400 --> 00:41:27,680 THE HIV RESEARCH WORKFORCE. 1063 00:41:27,680 --> 00:41:30,560 A SUSTAINED DIVERSE HIV RESEARCH 1064 00:41:30,560 --> 00:41:31,600 WORKFORCE IS ESSENTIAL TO 1065 00:41:31,600 --> 00:41:33,440 CONTINUE MOMENTUM TO END THE HIV 1066 00:41:33,440 --> 00:41:35,120 EPIDEMIC. 1067 00:41:35,120 --> 00:41:36,960 OAR HAS PARTNERED WITH MULTIPLE 1068 00:41:36,960 --> 00:41:38,480 ICOs TO PROVIDE CAREER 1069 00:41:38,480 --> 00:41:41,000 DEVELOPMENT RESOURCES AND 1070 00:41:41,000 --> 00:41:42,760 OPPORTUNITIES INCLUDING AN EARLY 1071 00:41:42,760 --> 00:41:44,520 CAREER INVESTIGATOR RESOURCE 1072 00:41:44,520 --> 00:41:47,360 PAGE ON THE OAR WEBSITE. 1073 00:41:47,360 --> 00:41:50,000 IN 2022, OAR LAUNCHED THE 1074 00:41:50,000 --> 00:41:52,000 INAUGURAL VIRTUAL EARLY CAREER 1075 00:41:52,000 --> 00:41:54,080 INVESTIGATOR WORKSHOP, AND AT 1076 00:41:54,080 --> 00:41:56,680 THIS TIME, I'D LIKE TO THANK 1077 00:41:56,680 --> 00:41:58,480 NIAID AND ALL THE ICs FOR 1078 00:41:58,480 --> 00:42:02,520 SUPPORTING THE SECOND 2023 1079 00:42:02,520 --> 00:42:03,480 WORKSHOP FOR EARLY CAREER 1080 00:42:03,480 --> 00:42:04,560 INVESTIGATORS IN HIV SCHEDULED 1081 00:42:04,560 --> 00:42:13,360 FOR APRIL 24TH. 1082 00:42:13,360 --> 00:42:15,080 IN THE NEXT SLIDE. 1083 00:42:15,080 --> 00:42:19,800 FOR 35 YEARS, OAR HAS 1084 00:42:19,800 --> 00:42:21,560 COORDINATED THE PROGRAM 1085 00:42:21,560 --> 00:42:23,520 CONVENING MULTIPLE PARTNERS TO 1086 00:42:23,520 --> 00:42:24,280 CATALYZE INTERDISCIPLINARY 1087 00:42:24,280 --> 00:42:24,480 EFFORTS. 1088 00:42:24,480 --> 00:42:25,640 SO WHAT'S NEXT? 1089 00:42:25,640 --> 00:42:29,120 OUR GOAL REMAINS THE SAME. 1090 00:42:29,120 --> 00:42:31,520 END THE HIV PANDEMIC AND IMPROVE 1091 00:42:31,520 --> 00:42:33,080 THE HEALTH OF PEOPLE WITH HIV. 1092 00:42:33,080 --> 00:42:35,520 AND TO ACCOMPLISH THIS GOAL, WE 1093 00:42:35,520 --> 00:42:38,120 MUST FOCUS ON ACTION TO PREVENT, 1094 00:42:38,120 --> 00:42:41,240 TO TREAT, AND TO CURE. 1095 00:42:41,240 --> 00:42:43,120 THESE ACTIONS WILL REQUIRE 1096 00:42:43,120 --> 00:42:44,640 CONTINUED COMMITMENT, INNOVATION 1097 00:42:44,640 --> 00:42:47,720 AND CREATIVITY. 1098 00:42:47,720 --> 00:42:49,760 TO REDUCE ANY EFFORTS NOW WOULD 1099 00:42:49,760 --> 00:42:54,040 LEAD TO THE RESURGENCE OF HIV 1100 00:42:54,040 --> 00:42:55,160 WORLDWIDE, COMPROMISING GLOBAL 1101 00:42:55,160 --> 00:42:58,680 HEALTH IN THE 21ST CENTURY. 1102 00:42:58,680 --> 00:43:00,680 WE MUST BE NIMBLE TO RESPOND TO 1103 00:43:00,680 --> 00:43:03,160 NEW CHALLENGES, LEVERAGE NEW AND 1104 00:43:03,160 --> 00:43:05,280 EXISTING PARTNERSHIPS, ENSURE 1105 00:43:05,280 --> 00:43:07,560 THAT ALL VOICES CAN CONTRIBUTE 1106 00:43:07,560 --> 00:43:09,040 AND THERE IS ROOM FOR ALL AT THE 1107 00:43:09,040 --> 00:43:11,160 TABLE. 1108 00:43:11,160 --> 00:43:14,560 WE MUST BUILD ON OUR ROBUST 1109 00:43:14,560 --> 00:43:16,560 REPERTOIRE OF OPTIONS THAT CAN 1110 00:43:16,560 --> 00:43:19,760 IMPROVE PREVENTION AND TREATMENT 1111 00:43:19,760 --> 00:43:20,520 STRATEGIES. 1112 00:43:20,520 --> 00:43:21,800 MEANWHILE, THE SCIENTIFIC AGENDA 1113 00:43:21,800 --> 00:43:24,240 WILL CONTINUE TO SUPPORT 1114 00:43:24,240 --> 00:43:25,640 MULTIDISCIPLINARY INNOVATIVE 1115 00:43:25,640 --> 00:43:29,840 RESEARCH IN I IMMUNOLOGY, 1116 00:43:29,840 --> 00:43:30,800 VIROLOGY, THE BEHAVIORAL AND 1117 00:43:30,800 --> 00:43:35,520 SOCIAL SCIENCES, AS WELL AS 1118 00:43:35,520 --> 00:43:37,040 IMPLEMENTATION RESEARCH WHICH IS 1119 00:43:37,040 --> 00:43:38,480 KEY FOR DISCOVERY TO THE 1120 00:43:38,480 --> 00:43:40,000 COMMUNITIES WHO WOULD BENEFIT 1121 00:43:40,000 --> 00:43:40,520 THE MOST. 1122 00:43:40,520 --> 00:43:42,720 AS WE HEARD FROM DR. TONY FAUCI 1123 00:43:42,720 --> 00:43:45,240 AT OAR'S NIH WORLD AIDS DAY 1124 00:43:45,240 --> 00:43:48,560 EVENT LAST MONTH, ENDING THE 1125 00:43:48,560 --> 00:43:50,480 PANDEMIC, THE HIV PANDEMIC, IS 1126 00:43:50,480 --> 00:43:54,240 AN AMBITIOUS BUT FEASIBLE GOAL 1127 00:43:54,240 --> 00:43:55,800 AT NIAID, ONE THAT WE CAN 1128 00:43:55,800 --> 00:43:56,040 ACHIEVE. 1129 00:43:56,040 --> 00:43:59,440 THANK YOU. 1130 00:43:59,440 --> 00:44:03,240 >>THANK YOU, DR. GOODENOW, FOR 1131 00:44:03,240 --> 00:44:04,320 REALLY IMPRESSIVELY FOCUSED 1132 00:44:04,320 --> 00:44:06,320 INITIATIVES AND THOUGHTS AND 1133 00:44:06,320 --> 00:44:08,600 PARTICULARLY EXCITING TO SEE THE 1134 00:44:08,600 --> 00:44:11,120 BREADTH OF EFFORT ACROSS ALL OF 1135 00:44:11,120 --> 00:44:12,920 THE INSTITUTES, CENTERS AND 1136 00:44:12,920 --> 00:44:16,120 OFFICES, EVEN AS WE ARE SPEAKING 1137 00:44:16,120 --> 00:44:18,560 WITHIN THE DIVISION OF AIDS AT 1138 00:44:18,560 --> 00:44:19,920 NIAID, HOW BROAD THOSE EFFORTS 1139 00:44:19,920 --> 00:44:20,840 ARE. 1140 00:44:20,840 --> 00:44:21,880 MAYBE WE'LL TAKE TIME FOR A 1141 00:44:21,880 --> 00:44:24,800 COUPLE OF QUESTIONS. 1142 00:44:24,800 --> 00:44:27,360 DR. FRANK? 1143 00:44:27,360 --> 00:44:29,200 >>THANKS, KEN. 1144 00:44:29,200 --> 00:44:30,280 DR. GOODENOW, THIS IS IAN FRANK 1145 00:44:30,280 --> 00:44:32,080 FROM THE UNIVERSITY OF 1146 00:44:32,080 --> 00:44:32,480 PENNSYLVANIA. 1147 00:44:32,480 --> 00:44:35,040 ABOUT A WEEK 1/2 AGO IN 1148 00:44:35,040 --> 00:44:37,040 PREPARATION FOR THIS CALL TODAY, 1149 00:44:37,040 --> 00:44:41,080 WE HAD A PRELIMINARY CALL WITH 1150 00:44:41,080 --> 00:44:42,480 CARL, AND HE SHARED SOME 1151 00:44:42,480 --> 00:44:43,360 INFORMATION ABOUT THE NUMBER OF 1152 00:44:43,360 --> 00:44:45,760 K AWARDS THAT HAD BEEN FUNDED 1153 00:44:45,760 --> 00:44:51,480 THROUGH NIAID THE FACT 1154 00:44:51,480 --> 00:44:53,440 THAT IT WAS A NUMBER THAT WAS 1155 00:44:53,440 --> 00:44:54,640 SMALLER THAN IT HAD BEEN IN 1156 00:44:54,640 --> 00:44:55,080 RECENT YEARS. 1157 00:44:55,080 --> 00:44:56,280 I THINK THE NUMBER WAS FIVE, IF 1158 00:44:56,280 --> 00:44:57,280 I REMEMBER THAT NUMBER 1159 00:44:57,280 --> 00:44:57,600 CORRECTLY. 1160 00:44:57,600 --> 00:45:00,680 SO I'M WONDERING HOW MANY EARLY 1161 00:45:00,680 --> 00:45:02,200 STAGE CAREER INVESTIGATOR AWARDS 1162 00:45:02,200 --> 00:45:04,960 HAVE BEEN FUNDED THROUGH ALL OF 1163 00:45:04,960 --> 00:45:09,080 THE INSTITUTES, AND IS THAT 1164 00:45:09,080 --> 00:45:10,280 NUMBER ALSO IN THE DECLINE? 1165 00:45:10,280 --> 00:45:11,520 ARE THERE ANY INSTITUTES WHERE 1166 00:45:11,520 --> 00:45:12,920 THE NUMBER OF APPLICATIONS HAS 1167 00:45:12,920 --> 00:45:16,400 INCREASED? 1168 00:45:16,400 --> 00:45:20,200 >>THE OVERALL NUMBER FOR HIV 1169 00:45:20,200 --> 00:45:23,160 ARE NEW INVESTIGATORS RECEIVING 1170 00:45:23,160 --> 00:45:27,000 R01 OR R01 EQUIVALENTS IS IN THE 1171 00:45:27,000 --> 00:45:28,560 RANGE OF ABOUT 60 CURRENTLY AT 1172 00:45:28,560 --> 00:45:29,120 THE NIH. 1173 00:45:29,120 --> 00:45:33,400 AND THAT COMPARES, IF YOU USE 1174 00:45:33,400 --> 00:45:35,480 R01 EQUIVALENTS AS YOUR 1175 00:45:35,480 --> 00:45:37,440 DENOMINATOR, THEN AT THE TOTAL 1176 00:45:37,440 --> 00:45:40,960 NIH LEVEL, THE PERCENT OF AWARDS 1177 00:45:40,960 --> 00:45:42,720 OVERALL THAT ARE GOING TO NEW 1178 00:45:42,720 --> 00:45:46,000 INVESTIGATORS ACROSS THE NIH IS 1179 00:45:46,000 --> 00:45:46,680 ABOUT 5%. 1180 00:45:46,680 --> 00:45:48,960 WITHIN THE HIV AREA, IT'S A 1181 00:45:48,960 --> 00:45:49,920 LITTLE UNDER 4%. 1182 00:45:49,920 --> 00:45:52,040 SO ON A PERCENT-WISE BASIS, 1183 00:45:52,040 --> 00:45:54,280 WE'RE NOT AT THE SAME 1184 00:45:54,280 --> 00:45:55,800 PROPORTIONAL LEVEL AS THE REST 1185 00:45:55,800 --> 00:45:57,880 OF THE NIH. 1186 00:45:57,880 --> 00:45:58,920 >>K AWARDS. 1187 00:45:58,920 --> 00:46:00,120 WHAT ABOUT K AWARDS? 1188 00:46:00,120 --> 00:46:01,720 >>K AWARDS ARE IN A DIFFERENT 1189 00:46:01,720 --> 00:46:03,960 CLASS, AND I DON'T HAVE THOSE 1190 00:46:03,960 --> 00:46:05,840 NUMBERS AT THE TOP OF MY HEAD 1191 00:46:05,840 --> 00:46:07,160 RIGHT AT THIS MOMENT, BUT WE CAN 1192 00:46:07,160 --> 00:46:10,680 GET YOU THAT INFORMATION. 1193 00:46:10,680 --> 00:46:14,520 BUT IN GENERAL, THE IC -- IT 1194 00:46:14,520 --> 00:46:17,200 DEPENDS ON THE IC, WHICH ONES 1195 00:46:17,200 --> 00:46:18,600 ARE FUNDING MORE OR LESS, 1196 00:46:18,600 --> 00:46:20,000 BECAUSE THIS IS DEFINITELY 1197 00:46:20,000 --> 00:46:24,400 WITHIN THE IC PARAMETERS, WE CAN 1198 00:46:24,400 --> 00:46:25,520 PROVIDE THE DATA AND ENCOURAGE 1199 00:46:25,520 --> 00:46:26,760 THEM TO INCREASE THAT, AND WE, 1200 00:46:26,760 --> 00:46:33,840 IN FACT, HAVE BEEN USING OUR 1201 00:46:33,840 --> 00:46:35,920 RESOURCES TO SORT OF JUMP-START 1202 00:46:35,920 --> 00:46:41,200 SOME NEW FUNDING IN THIS AREA. 1203 00:46:41,200 --> 00:46:41,640 >>THANKS. 1204 00:46:41,640 --> 00:46:42,800 >>CERTAINLY THE RED LINE THAT 1205 00:46:42,800 --> 00:46:44,280 YOU SHOWED ON THAT GRAPH WITH 1206 00:46:44,280 --> 00:46:46,360 THE ESIs IN HIV GOING DOWN 1207 00:46:46,360 --> 00:46:47,600 WHILE EVERYONE ELSE WAS GOING UP 1208 00:46:47,600 --> 00:46:48,800 WAS NOT SOMETHING THAT ANY OF US 1209 00:46:48,800 --> 00:46:49,800 LIKE TO SEE. 1210 00:46:49,800 --> 00:46:52,640 SO WE'LL PUT OUR HEADS TOGETHER 1211 00:46:52,640 --> 00:46:53,640 AND THINK ABOUT WHAT WE CAN DO. 1212 00:46:53,640 --> 00:46:55,920 THANK YOU, DR. GOODENOW. 1213 00:46:55,920 --> 00:46:59,240 WHY DON'T WE MOVE ON AS WE MOVE 1214 00:46:59,240 --> 00:47:00,880 TO THE PROGRAMMATIC OVERVIEW, 1215 00:47:00,880 --> 00:47:02,600 AND LET ME REMIND EVERYONE TO 1216 00:47:02,600 --> 00:47:04,120 THINK ABOUT QUESTIONS 1217 00:47:04,120 --> 00:47:05,360 PARTICULARLY AROUND THE COVID 1218 00:47:05,360 --> 00:47:06,680 RESPONSE THAT WE'LL HAVE TIME 1219 00:47:06,680 --> 00:47:07,640 FOR IN THE DISCUSSION AT THE 1220 00:47:07,640 --> 00:47:08,560 END. 1221 00:47:08,560 --> 00:47:12,280 I'M GOING TO TURN IT OVER TO 1222 00:47:12,280 --> 00:47:14,240 DIANA FINZI, DIRECTOR OF THE 1223 00:47:14,240 --> 00:47:15,800 BASIC SCIENCES PROGRAM, FOR THE 1224 00:47:15,800 --> 00:47:16,760 NEXT PIECE OF THIS. 1225 00:47:16,760 --> 00:47:19,840 DR. FINZI. 1226 00:47:19,840 --> 00:47:21,600 >>YES, HELLO, EVERYONE. 1227 00:47:21,600 --> 00:47:28,520 AND JUST GIVE ME ONE MINUTE TO 1228 00:47:28,520 --> 00:47:38,800 SHARE MY SCREEN. 1229 00:47:40,480 --> 00:47:42,080 AND TO MOVE YOU OUT OF MY WAY. 1230 00:47:42,080 --> 00:47:42,600 OKAY. 1231 00:47:42,600 --> 00:47:47,200 SO GOOD AFTERNOON, EVERYONE. 1232 00:47:47,200 --> 00:47:48,640 I WILL START WITH AN OVERVIEW OF 1233 00:47:48,640 --> 00:47:52,240 THE BASIC SCIENCES PROGRAM, AND 1234 00:47:52,240 --> 00:47:53,920 THEN I'LL GIVE YOU SOME 1235 00:47:53,920 --> 00:47:56,240 HIGHLIGHTS FROM THREE IMPORTANT 1236 00:47:56,240 --> 00:47:59,080 AREAS FOR -- FOR MY PROGRAM IN 1237 00:47:59,080 --> 00:48:01,080 STRUCTURAL BIOLOGY, HIV CURE, 1238 00:48:01,080 --> 00:48:04,680 AND ENDING THE HIV EPIDEMIC. 1239 00:48:04,680 --> 00:48:06,320 I WILL TOUCH ON LESSONS LEARNED 1240 00:48:06,320 --> 00:48:07,320 WITH COVID THROUGHOUT THE TALK 1241 00:48:07,320 --> 00:48:08,760 AND WILL ALSO INCORPORATE 1242 00:48:08,760 --> 00:48:10,080 LESSONS LEARNED WHEN I DISCUSS 1243 00:48:10,080 --> 00:48:11,600 FUTURE DIRECTIONS. 1244 00:48:11,600 --> 00:48:13,960 A RECURRING THEME FROM MY GROUP 1245 00:48:13,960 --> 00:48:16,960 IS THAT OF LEVERAGING RESOURCES, 1246 00:48:16,960 --> 00:48:19,400 AND COLLABORATING AT EVERY 1247 00:48:19,400 --> 00:48:22,600 POSSIBLE OPPORTUNITY. 1248 00:48:22,600 --> 00:48:26,720 SO NOW I PROMISE I DID NOT 1249 00:48:26,720 --> 00:48:32,720 COORDINATE WITH KEN ON THIS, BUT 1250 00:48:32,720 --> 00:48:34,720 WE HAD VERY SIMILAR WORDS, WHICH 1251 00:48:34,720 --> 00:48:38,720 IS IF YOU THINK ABOUT IT, DEPTH 1252 00:48:38,720 --> 00:48:40,320 OF KNOWLEDGE GENERATED BY HIV 1253 00:48:40,320 --> 00:48:42,520 RESEARCH OVER THE PAST 40 YEARS 1254 00:48:42,520 --> 00:48:44,960 IS UNSURPASSED BY THE STUDY OF 1255 00:48:44,960 --> 00:48:46,320 ANY OTHER PATHOGEN. 1256 00:48:46,320 --> 00:48:48,560 NOT ONLY HAVE WE MADE ENORMOUS 1257 00:48:48,560 --> 00:48:50,360 STRIDES IN UNDERSTANDING HIV, 1258 00:48:50,360 --> 00:48:53,000 BUT WE'VE ALSO GAINED KEY 1259 00:48:53,000 --> 00:48:54,320 INSIGHTS ON OTHER VIRUSES. 1260 00:48:54,320 --> 00:48:56,160 FOR EXAMPLE, HIV LAID THE 1261 00:48:56,160 --> 00:48:58,280 FOUNDATION FOR UNDERSTANDING 1262 00:48:58,280 --> 00:49:00,800 ENTRY OF SARS-COV-2, AS WELL AS 1263 00:49:00,800 --> 00:49:04,760 THE MRNA TECHNOLOGY FOR THE 1264 00:49:04,760 --> 00:49:05,280 VACCINES. 1265 00:49:05,280 --> 00:49:06,720 AND THROUGH HIV, WE HAVE LEARNED 1266 00:49:06,720 --> 00:49:08,160 ABOUT THE COMPLEXITIES OF THE 1267 00:49:08,160 --> 00:49:09,800 IMMUNE SYSTEM, WE HAVE LEARNED 1268 00:49:09,800 --> 00:49:14,200 ABOUT HOW T-CELLS, B-CELLS AND 1269 00:49:14,200 --> 00:49:16,600 K-CELLS, MACROPHAGES, 1270 00:49:16,600 --> 00:49:17,720 ORCHESTRATE AN ATTACK AND HOW 1271 00:49:17,720 --> 00:49:20,160 SPECIFICALLY MOLECULES RECOGNIZE 1272 00:49:20,160 --> 00:49:22,440 AND BIND TO STRUCTURES, TO 1273 00:49:22,440 --> 00:49:23,760 PATHOGENIC STRUCTURES AND HOW 1274 00:49:23,760 --> 00:49:26,280 THEY WORK TOGETHER TO TARGET AND 1275 00:49:26,280 --> 00:49:29,240 CLEAR VIRUSES. 1276 00:49:29,240 --> 00:49:32,520 THIS LARGE BODY OF WORK HAS 1277 00:49:32,520 --> 00:49:38,720 CONTRIBUTED TO CRITICAL DISCOVEY 1278 00:49:38,720 --> 00:49:40,080 STRONG FOUNDATION TO ADDRESS 1279 00:49:40,080 --> 00:49:49,160 OTHER DISEASES AS DIVERSE AS 1280 00:49:49,160 --> 00:49:49,720 CURING CANCER. 1281 00:49:49,720 --> 00:49:51,160 MOST OF WHAT WE DO IS PROVIDE 1282 00:49:51,160 --> 00:49:52,000 EARLY STAGE SCIENCE. 1283 00:49:52,000 --> 00:49:53,480 THE EARLY INDICATIONS OF WHAT 1284 00:49:53,480 --> 00:49:55,960 MIGHT EVENTUALLY LEAD TO 1285 00:49:55,960 --> 00:49:58,040 IMPORTANT BREAKTHROUGHS. 1286 00:49:58,040 --> 00:49:59,240 OUR FOUNDATIONS ARE IN A LARGE 1287 00:49:59,240 --> 00:50:01,160 NUMBER OF UNSOLICITED GRANTS, 1288 00:50:01,160 --> 00:50:03,000 BUT WE ALSO SOLICIT GRANTS IN 1289 00:50:03,000 --> 00:50:05,040 ORDER TO INDICATE OUR DIRECTION 1290 00:50:05,040 --> 00:50:08,840 IN AREAS OF PARTICULAR NEED. 1291 00:50:08,840 --> 00:50:11,680 WE WORK WITH OTHER PROGRAMS, WE 1292 00:50:11,680 --> 00:50:13,320 WORK WITH THERAPEUTICS 1293 00:50:13,320 --> 00:50:16,160 PREVENTION AND VACCINES, AND 1294 00:50:16,160 --> 00:50:19,560 OFTEN SEE OUR EARLY WORK BEAR 1295 00:50:19,560 --> 00:50:21,680 FRUIT IN THOSE AREAS. 1296 00:50:21,680 --> 00:50:24,360 AND WITH OUR BREADTH AND 1297 00:50:24,360 --> 00:50:26,160 RESOURCES SUCH AS THE CENTERS 1298 00:50:26,160 --> 00:50:27,680 FOR AIDS RESEARCH, WE'RE OFTEN 1299 00:50:27,680 --> 00:50:29,880 ABLE TO PLANT LITTLE SEEDS TO 1300 00:50:29,880 --> 00:50:33,440 GENERATE NEW IDEAS, SUPPORTING A 1301 00:50:33,440 --> 00:50:35,720 WIDE BASE FOR EXPLORATION AND 1302 00:50:35,720 --> 00:50:38,240 FEEDING THE PIPELINE WITH DEPTH 1303 00:50:38,240 --> 00:50:39,760 AND DIVERSITY OF PROJECTS. 1304 00:50:39,760 --> 00:50:42,320 SO I HOPE TO GIVE YOU A FEEL FOR 1305 00:50:42,320 --> 00:50:46,760 THE GREAT BREAD OF THE BREADTH O 1306 00:50:46,760 --> 00:50:48,000 IN BSP. 1307 00:50:48,000 --> 00:50:49,880 BSP IS CAN COMPOSED OF THREE 1308 00:50:49,880 --> 00:50:52,640 BRANCHES. 1309 00:50:52,640 --> 00:50:54,360 JASON AND ANNE ACT AS MY 1310 00:50:54,360 --> 00:50:55,600 DEPUTIES, AND BRITTANY THOMPSON 1311 00:50:55,600 --> 00:50:57,560 IS OUR EXTRAMURAL SUPPORT 1312 00:50:57,560 --> 00:50:58,200 ASSISTANT. 1313 00:50:58,200 --> 00:51:00,760 THE PATHOGENESIS AND BASIC 1314 00:51:00,760 --> 00:51:02,760 RESEARCH BRANCH IS LED BY CARL, 1315 00:51:02,760 --> 00:51:04,600 THE TARGETED INTERVENTIONS 1316 00:51:04,600 --> 00:51:06,800 BRANCH BY SANDRA BRIDGES GURGO, 1317 00:51:06,800 --> 00:51:08,880 AND THE EPIDEMIOLOGY BRANCH BY C 1318 00:51:08,880 --> 00:51:12,480 ARC RLIE WILLIAMS. 1319 00:51:12,480 --> 00:51:14,840 COLLECTIVELY, BSP OVERSEES OVER 1320 00:51:14,840 --> 00:51:16,680 550 GRANTS WITH AN ANNUAL BUDGET 1321 00:51:16,680 --> 00:51:18,280 OF OVER $400 MILLION. 1322 00:51:18,280 --> 00:51:20,200 WE ALSO OVERSEE SEVERAL 1323 00:51:20,200 --> 00:51:23,400 CONTRACTS THAT FOR THE MOST PART 1324 00:51:23,400 --> 00:51:24,840 PROVIDE SERVICES FOR THE FIELD, 1325 00:51:24,840 --> 00:51:29,320 SUCH AS THE AIDS REAGENT 1326 00:51:29,320 --> 00:51:29,640 PROGRAM. 1327 00:51:29,640 --> 00:51:32,080 SO OUR PRIMARY FOCUS IN THE 1328 00:51:32,080 --> 00:51:34,800 BRANCHES, IN THE PATHOGENESIS IN 1329 00:51:34,800 --> 00:51:36,560 BASIC RESEARCH BRANCH IS ON 1330 00:51:36,560 --> 00:51:37,760 MECHANISTIC WORK WITH PARTICULAR 1331 00:51:37,760 --> 00:51:39,640 ATTENTION TO LATENCY, 1332 00:51:39,640 --> 00:51:41,400 PERSISTENCE AND CURE. 1333 00:51:41,400 --> 00:51:43,040 AND OUR TARGETED INTERVENTIONS 1334 00:51:43,040 --> 00:51:44,520 BRANCH, WE HAVE AN INCREASED 1335 00:51:44,520 --> 00:51:46,560 FOCUS ON NON-TRADITIONAL 1336 00:51:46,560 --> 00:51:48,760 THERAPEUTICS, SUCH AS GENE AND 1337 00:51:48,760 --> 00:51:50,960 CELL-BASED THERAPIES, BIOLOGICS, 1338 00:51:50,960 --> 00:51:52,480 AND RNA THERAPEUTICS, BUT WE 1339 00:51:52,480 --> 00:51:55,160 ALSO CONTINUE WORK ON SPECIFIC 1340 00:51:55,160 --> 00:51:57,600 INTERVENTIONS TO VALIDATE HIV 1341 00:51:57,600 --> 00:51:59,160 TARGETS AND SMALL MOLECULE 1342 00:51:59,160 --> 00:52:00,040 INHIBITORS. 1343 00:52:00,040 --> 00:52:02,800 IN THE EPIDEMIOLOGY BRANCH, OUR 1344 00:52:02,800 --> 00:52:05,640 WORK FOCUSES ON CLINICAL 1345 00:52:05,640 --> 00:52:07,280 OUTCOMES OF HIV THROUGH VERY 1346 00:52:07,280 --> 00:52:09,360 LARGE COHORTS THROUGHOUT THE 1347 00:52:09,360 --> 00:52:11,600 WORLD, AND ON ELECTRONIC HEALTH 1348 00:52:11,600 --> 00:52:13,600 RECORDS RESEARCH. 1349 00:52:13,600 --> 00:52:15,640 RECENTLY FOCUSING MORE ON 1350 00:52:15,640 --> 00:52:16,560 TUBERCULOSIS AND THE 1351 00:52:16,560 --> 00:52:19,640 INTERSECTION OF TB AND HIV. 1352 00:52:19,640 --> 00:52:22,360 THE EPIDEMIOLOGY BRANCH HAS ALSO 1353 00:52:22,360 --> 00:52:23,800 EXPANDED SUPPORT OF NEW 1354 00:52:23,800 --> 00:52:25,320 SURVEILLANCE APPROACHES TO 1355 00:52:25,320 --> 00:52:27,760 IDENTIFY PEOPLE WHO ARE AT RISK 1356 00:52:27,760 --> 00:52:29,920 OF INFECTION AND PEOPLE WHO ARE 1357 00:52:29,920 --> 00:52:35,640 AT RISK OF INADEQUATE TREATMENT. 1358 00:52:35,640 --> 00:52:37,320 AND NOW THREE YEARS INTO THE 1359 00:52:37,320 --> 00:52:40,920 FEDERAL ENDING THE HIV EPIDEMIC, 1360 00:52:40,920 --> 00:52:43,080 WHERE OUR CFAR TEAM ALONG WITH 1361 00:52:43,080 --> 00:52:46,200 OUR NATIONAL INSTITUTE OF MENTAL 1362 00:52:46,200 --> 00:52:47,200 HEALTH COLLEAGUES HAVE TAKEN THE 1363 00:52:47,200 --> 00:52:48,520 LEAD FOR THE NIH AND ESTABLISHED 1364 00:52:48,520 --> 00:52:50,600 A PARTNERSHIP WITH THE OFFICE OF 1365 00:52:50,600 --> 00:52:55,560 AIDS RESEARCH, THE CDC, AND HRSA 1366 00:52:55,560 --> 00:52:58,480 TO ACHIEVE EAG GOALS. 1367 00:52:58,480 --> 00:53:00,760 OUR EFFORTS HAVE RESULTED IN 1368 00:53:00,760 --> 00:53:03,040 INCREASED EFFORT AND ALIGNMENT 1369 00:53:03,040 --> 00:53:04,960 TO FUND HIV IMPLEMENTATION 1370 00:53:04,960 --> 00:53:06,320 SCIENCE RESEARCH. 1371 00:53:06,320 --> 00:53:08,120 SO YOU CAN ALREADY SEE FROM HERE 1372 00:53:08,120 --> 00:53:10,840 THAT THE BREADTH OF WHAT WE DO 1373 00:53:10,840 --> 00:53:13,240 IN BSP IS REALLY QUITE GREAT. 1374 00:53:13,240 --> 00:53:15,800 IT RANGES FROM BASIC SCIENCE AT 1375 00:53:15,800 --> 00:53:18,640 THE SUBCELLULAR ATOMIC LEVEL TO 1376 00:53:18,640 --> 00:53:20,640 UNDERSTANDING THE BIOLOGY AND 1377 00:53:20,640 --> 00:53:23,400 THE IMMUNOLOGY OF HIV, TO 1378 00:53:23,400 --> 00:53:26,240 EPIDEMIOLOGY AND THE DYNAMICS OF 1379 00:53:26,240 --> 00:53:29,840 HIV TRANSMISSION BETWEEN PEOPLE. 1380 00:53:29,840 --> 00:53:32,680 SO NOW I'M GOING TO START SMALL 1381 00:53:32,680 --> 00:53:34,400 WITH A VERY EXCITING STORY FROM 1382 00:53:34,400 --> 00:53:37,600 OUR STRUCTURAL BIOLOGY CENTERS. 1383 00:53:37,600 --> 00:53:39,680 SO JUST ABOUT 20 YEARS AGO, WE 1384 00:53:39,680 --> 00:53:41,520 STARTED A CLOSE COLLABORATION 1385 00:53:41,520 --> 00:53:44,000 WITH NIGMS WHERE TOGETHER WE 1386 00:53:44,000 --> 00:53:45,760 LAUNCHED THREE CENTERS FOR HIV 1387 00:53:45,760 --> 00:53:49,040 STRUCTURAL BIOLOGY, FUNDED 1388 00:53:49,040 --> 00:53:50,560 MOSTLY BY NIGMS. 1389 00:53:50,560 --> 00:53:54,200 AND THEN A FEW YEARS AGO IN 1390 00:53:54,200 --> 00:53:56,280 2019, WE TOOK OVER THE ENTIRE 1391 00:53:56,280 --> 00:53:59,880 HIV STRUCTURAL BIOLOGY PORTFOLIO 1392 00:53:59,880 --> 00:54:02,040 FROM NIGMS AND EXPANDED THE 1393 00:54:02,040 --> 00:54:04,520 PROGRAM AND WE NOW HAVE SIX 1394 00:54:04,520 --> 00:54:05,720 CENTERS. 1395 00:54:05,720 --> 00:54:09,280 SO MY FIRST SCIENTIFIC HIGHLIGHT 1396 00:54:09,280 --> 00:54:10,680 IS ABOUT A NEW DRUG THAT HAS 1397 00:54:10,680 --> 00:54:17,400 BEEN DEVELOPED CALLED 1398 00:54:17,400 --> 00:54:19,520 LENOCAPIVIR AND IT'S BASED ON 1399 00:54:19,520 --> 00:54:23,160 FUNDAMENTAL SCIENCE DONE BY WEST 1400 00:54:23,160 --> 00:54:24,880 SUNDQUIST AT THE CHEETAH CENTER 1401 00:54:24,880 --> 00:54:26,120 LISTED HERE AND ALSO FROM 1402 00:54:26,120 --> 00:54:27,760 INVESTIGATORS IN THE FOUR OTHER 1403 00:54:27,760 --> 00:54:29,320 CENTERS THAT ARE HIGHLIGHTED IN 1404 00:54:29,320 --> 00:54:31,920 RED. 1405 00:54:31,920 --> 00:54:33,160 AND AS I MENTIONED BEFORE, I 1406 00:54:33,160 --> 00:54:35,840 THINK TO THIS GROUP, ONE OF THE 1407 00:54:35,840 --> 00:54:37,520 HARDEST PARTS WITH BASIC SCIENCE 1408 00:54:37,520 --> 00:54:39,400 IS THAT THE PAYOFF CAN TAKE 1409 00:54:39,400 --> 00:54:42,600 MANY, MANY YEARS TO EMERGE, AND 1410 00:54:42,600 --> 00:54:44,480 PEOPLE OFTEN PREFER SEEING 1411 00:54:44,480 --> 00:54:45,360 IMMEDIATE RESULTS. 1412 00:54:45,360 --> 00:54:46,800 THE COMMENT "PRETTY PICTURES BUT 1413 00:54:46,800 --> 00:54:48,680 WHAT WILL DO FOR ME" IS PRETTY 1414 00:54:48,680 --> 00:54:50,040 TYPICAL. 1415 00:54:50,040 --> 00:54:51,960 IT'S REALLY HARD TO GENERATE 1416 00:54:51,960 --> 00:54:54,560 EXCITEMENT FOR WORK THAT ISN'T 1417 00:54:54,560 --> 00:54:55,560 IMMEDIATELY TRANSLATABLE. 1418 00:54:55,560 --> 00:54:58,160 SO NOW I'LL SHOW YOU SOME PRETTY 1419 00:54:58,160 --> 00:55:01,040 PICTURES, AND HOPEFULLY WE'LL 1420 00:55:01,040 --> 00:55:03,400 GIVE YOU AN IDEA OF THE 1421 00:55:03,400 --> 00:55:06,080 IMPORTANCE OF INVESTING IN BASIC 1422 00:55:06,080 --> 00:55:06,520 SCIENCE. 1423 00:55:06,520 --> 00:55:10,880 AN EXAMPLE OF THAT. 1424 00:55:10,880 --> 00:55:12,360 SO WE'RE ALL FAMILIAR WITH THE 1425 00:55:12,360 --> 00:55:14,640 HIV LI LIFECYCLE. 1426 00:55:14,640 --> 00:55:15,960 THIS NEW DRUG ACTS ON PROTEINS 1427 00:55:15,960 --> 00:55:18,760 THAT MAKE UP THIS CONICAL 1428 00:55:18,760 --> 00:55:20,040 STRUCTURE CALLED THE CORE. 1429 00:55:20,040 --> 00:55:23,200 THE CORE IS ESSENTIAL DURING 1430 00:55:23,200 --> 00:55:24,760 ENTRY OF THE VIRUS AS IT 1431 00:55:24,760 --> 00:55:27,160 PROTECTS THE HIV'S GENETIC 1432 00:55:27,160 --> 00:55:29,360 INFORMATION FROM INNATE IMMUNE 1433 00:55:29,360 --> 00:55:30,680 SENSORS DURING REVERSE 1434 00:55:30,680 --> 00:55:33,560 TRANSCRIPTION, AND ALSO WHILE IT 1435 00:55:33,560 --> 00:55:35,600 TRAFFICS THROUGH THE CYTOPLASM 1436 00:55:35,600 --> 00:55:36,680 TO THE NUCLEUS. 1437 00:55:36,680 --> 00:55:41,440 THE CORE THEN FALLS APART -- OR 1438 00:55:41,440 --> 00:55:42,440 UNCOATS, AS GENETIC INFORMATION 1439 00:55:42,440 --> 00:55:44,040 IS RELEASED AND TRANSPORTED INTO 1440 00:55:44,040 --> 00:55:47,480 THE NUCLEUS FOR INTEGRATION. 1441 00:55:47,480 --> 00:55:50,280 ON THE RIGHT-HAND SIDE, CORE 1442 00:55:50,280 --> 00:55:53,880 ASSEMBLY IS ALSO VERY IMPORTANT, 1443 00:55:53,880 --> 00:55:55,960 AS THE VIRUS BUDS FROM THE CELL 1444 00:55:55,960 --> 00:55:57,320 AND CRITICAL TO THE LIFECYCLE, 1445 00:55:57,320 --> 00:55:58,600 AS WELL AS THE MATURING OF 1446 00:55:58,600 --> 00:55:59,720 CAPSID. 1447 00:55:59,720 --> 00:56:01,880 THE PROTEINS THAT MAKE UP THIS 1448 00:56:01,880 --> 00:56:10,360 CORE ARE CALLED CAPSID. 1449 00:56:10,360 --> 00:56:12,000 NOW EARLY WORK IN THE MID 1450 00:56:12,000 --> 00:56:15,640 1990s BY WES SUNDQUIST, MIKE 1451 00:56:15,640 --> 00:56:18,080 SOMERS AND CHRIS HILL'S GROUP 1452 00:56:18,080 --> 00:56:19,080 SHOWED THE BASIC STRUCTURE OF 1453 00:56:19,080 --> 00:56:21,040 THE CAPSID PROTEIN DIMER AND 1454 00:56:21,040 --> 00:56:24,120 FOUND THAT 750 OF THESE DIMERS 1455 00:56:24,120 --> 00:56:25,680 MUST COME TOGETHER TO FORM THE 1456 00:56:25,680 --> 00:56:27,320 CONE, BUT EXACTLY HOW THESE 1457 00:56:27,320 --> 00:56:29,680 DIMERS CAME TOGETHER TO FORM 1458 00:56:29,680 --> 00:56:33,360 THIS HIGHER SCALE CONICAL BUT 1459 00:56:33,360 --> 00:56:34,560 SLIGHTLY IRREGULAR STRUCTURE 1460 00:56:34,560 --> 00:56:35,800 REMAINED UNKNOWN. 1461 00:56:35,800 --> 00:56:39,800 ABOUT 10 YEARS LATER, WE BEGAN 1462 00:56:39,800 --> 00:56:40,680 TO HAVE CLARITY AROUND THIS 1463 00:56:40,680 --> 00:56:41,200 QUESTION. 1464 00:56:41,200 --> 00:56:43,400 THIS SLIDE SHOWS THE CAPSID 1465 00:56:43,400 --> 00:56:45,720 DIMER ON THE LEFT, AND THEN THE 1466 00:56:45,720 --> 00:56:49,360 ATOMIC STRUCTURES OF CAPSID 1467 00:56:49,360 --> 00:56:55,080 PENTAMERS AND HEXAMERS MADE OF . 1468 00:56:55,080 --> 00:56:57,400 THESE PENTAMERS AND HEXAMERS ARE 1469 00:56:57,400 --> 00:57:01,320 THE ESSENTIAL BUILDING BLOCKS, 1470 00:57:01,320 --> 00:57:03,480 AND THESE IMAGES REPRESENT THE 1471 00:57:03,480 --> 00:57:06,840 FIRST ATOMIC MODELS FOR THE HIV 1472 00:57:06,840 --> 00:57:09,680 CAPSID BUILDING BLOCKS. 1473 00:57:09,680 --> 00:57:12,440 AND THESE IMAGES ALSO STARTED TO 1474 00:57:12,440 --> 00:57:15,400 GIVE IMPORTANT HINTS TO ENABLING 1475 00:57:15,400 --> 00:57:19,320 STRUCTURE-BASED DESIGN. 1476 00:57:19,320 --> 00:57:20,680 NOW HERE, THIS IS THE FULL 1477 00:57:20,680 --> 00:57:23,520 STRUCTURE OF THE CORE. 1478 00:57:23,520 --> 00:57:26,720 THE FULERINE CONE, WHICH IS 1479 00:57:26,720 --> 00:57:29,040 COMPOSED OF 250 HEXAMERS, WHICH 1480 00:57:29,040 --> 00:57:30,840 ARE HERE IN ORANGE, AND 12 1481 00:57:30,840 --> 00:57:33,000 PENTAMERS IN YELLOW. 1482 00:57:33,000 --> 00:57:35,600 THIS WORK DEFINED THE FULL 1483 00:57:35,600 --> 00:57:37,520 ARCHITECTURE OF THE CAPSID OR 1484 00:57:37,520 --> 00:57:40,760 THE CORE STRUCTURE. 1485 00:57:40,760 --> 00:57:45,640 NOTE THAT THE RINGS ARE COMPOSED 1486 00:57:45,640 --> 00:57:47,920 OF AND HELD TOGETHER BY THE 1487 00:57:47,920 --> 00:57:52,360 CAPSID-DIMER INTERACTION. 1488 00:57:52,360 --> 00:57:56,840 NOW BASED ON THESE FINE DETAILS 1489 00:57:56,840 --> 00:57:59,080 OF THESE ANTIACTIONS, GILEAD 1490 00:57:59,080 --> 00:58:00,040 DEVELOPED AN ASSAY THAT SHOWED 1491 00:58:00,040 --> 00:58:02,400 HOW THE KINETICS OF CAPSID 1492 00:58:02,400 --> 00:58:04,040 ASSEMBLY WERE EITHER INHIBITED 1493 00:58:04,040 --> 00:58:06,520 OR ACTUALLY ACCELERATED WITH THE 1494 00:58:06,520 --> 00:58:14,160 ADDITION OF SMALL MOLECULE DRUG 1495 00:58:14,160 --> 00:58:14,600 CANDIDATES. 1496 00:58:14,600 --> 00:58:16,160 THEY THEN USED STRUCTURE-BASED 1497 00:58:16,160 --> 00:58:17,880 DESIGN TO DRIVE THE MEDICINAL 1498 00:58:17,880 --> 00:58:18,560 CHEMISTRY. 1499 00:58:18,560 --> 00:58:20,360 SO NOTE HERE ON THE LEFT THE 1500 00:58:20,360 --> 00:58:22,640 HIGH COMPLEXITY OF THIS 1501 00:58:22,640 --> 00:58:23,520 MOLECULE. 1502 00:58:23,520 --> 00:58:26,720 WHICH INCLUDES TWO STEREO 1503 00:58:26,720 --> 00:58:27,640 CENTERS, MULTIPLE DIFFERENT 1504 00:58:27,640 --> 00:58:30,560 TYPES OF ATOMS. 1505 00:58:30,560 --> 00:58:32,080 WES SUNDQUIST REFERS TO THIS AS 1506 00:58:32,080 --> 00:58:34,680 A HEROIC EFFORT BY GILEAD. 1507 00:58:34,680 --> 00:58:36,960 THE IMAGE ON THE RIGHT 1508 00:58:36,960 --> 00:58:38,480 HIGHLIGHTS THE FACT THAT THE 1509 00:58:38,480 --> 00:58:40,720 DRUG BINDS TO A POCKET IN THE 1510 00:58:40,720 --> 00:58:43,000 MIDDLE OF THE CAPSID DIMER, AND 1511 00:58:43,000 --> 00:58:45,200 SHOWS THAT ALL THE KNOWN SITES 1512 00:58:45,200 --> 00:58:48,040 OF DRUG RESISTANCE MAP TO THE 1513 00:58:48,040 --> 00:58:49,760 SITE, PROVING THAT THE CAPSID IS 1514 00:58:49,760 --> 00:58:57,120 THE THERAPEUTIC TARGET FOR THIS 1515 00:58:57,120 --> 00:58:57,320 DRUG. 1516 00:58:57,320 --> 00:58:58,320 IT'S IMPORTANT TO POINT OUT THAT 1517 00:58:58,320 --> 00:58:59,640 THE DRUG WAS DEVELOPED AT 1518 00:58:59,640 --> 00:59:00,400 GILEAD. 1519 00:59:00,400 --> 00:59:02,640 WES SUNDQUIST HELPED ESTABLISH 1520 00:59:02,640 --> 00:59:04,480 THE FOUNDATIONAL STRUCTURAL 1521 00:59:04,480 --> 00:59:05,920 BIOLOGY, AND HE HELPED SET UP 1522 00:59:05,920 --> 00:59:08,320 THE ASSAYS, BUT ALL OF THE DRUG 1523 00:59:08,320 --> 00:59:10,120 DEVELOPMENT, TESTING, ALL OF IT 1524 00:59:10,120 --> 00:59:11,760 WAS DONE BY GILEAD. 1525 00:59:11,760 --> 00:59:15,080 SO THIS IS REALLY AN EXAMPLE OF 1526 00:59:15,080 --> 00:59:16,480 EYE DEAN COLLABORATION BETWEEN 1527 00:59:16,480 --> 00:59:18,720 THE GOVERNMENT, ACADEMIA AND 1528 00:59:18,720 --> 00:59:20,000 INDUSTRY. 1529 00:59:20,000 --> 00:59:27,800 NOW I WANT TO SHOW HERE THE 1530 00:59:27,800 --> 00:59:30,080 POTENCY, IT'S A MORE POTENT 1531 00:59:30,080 --> 00:59:31,000 INHIBITOR THAN ANY OF THE COMMON 1532 00:59:31,000 --> 00:59:34,040 DRUGS USED IN THE CLINIC, 1533 00:59:34,040 --> 00:59:37,640 INCLUDING TAFF -- AND THEN THIS 1534 00:59:37,640 --> 00:59:40,960 NEXT SLIDE HERE SHOWS THAT AT 1535 00:59:40,960 --> 00:59:44,160 HIGHER DOSES, THE DARKER BLUE 1536 00:59:44,160 --> 00:59:51,080 LINES, LENACAPAVIR LASTS AT 1537 00:59:51,080 --> 00:59:51,880 THERAPEUTIC LEVEL FOR QUITE A 1538 00:59:51,880 --> 00:59:54,160 LONG TIME, SIX MONTHS, FOLLOWING 1539 00:59:54,160 --> 00:59:55,600 A SINGLE SUBCUTANEOUS DOSE. 1540 00:59:55,600 --> 01:00:00,800 SO THE KEY POINTS FOR THIS 1541 01:00:00,800 --> 01:00:01,440 LENACAPAVIR IS THAT IT IS A 1542 01:00:01,440 --> 01:00:03,320 FIRST IN CLASS CAPSID INHIBITOR, 1543 01:00:03,320 --> 01:00:06,840 IT BLOCKS MULTIPLE 1544 01:00:06,840 --> 01:00:08,200 CAPSID-DEPENDENT STEPS IN HIV 1545 01:00:08,200 --> 01:00:11,920 REPLICATION INCLUDING NUCLEAR 1546 01:00:11,920 --> 01:00:13,560 ENTRY -- IT HAS A GREAT PROFILE 1547 01:00:13,560 --> 01:00:15,280 AGAINST KNOWN RESISTANCE 1548 01:00:15,280 --> 01:00:17,440 MUTATIONS BECAUSE IT HITS A NEW 1549 01:00:17,440 --> 01:00:18,720 TARGET, AND IT NOW HAS BEEN 1550 01:00:18,720 --> 01:00:22,080 APPROVED FOR USE IN EUROPE AND 1551 01:00:22,080 --> 01:00:23,640 THE UNITED STATES IN ADULTS WHO 1552 01:00:23,640 --> 01:00:26,720 HAVE RESISTANT VIRUS. 1553 01:00:26,720 --> 01:00:27,560 WHILE IT'S GREAT AND VERY 1554 01:00:27,560 --> 01:00:32,960 IMPORTANT TO HAVE A NEW DRUG 1555 01:00:32,960 --> 01:00:34,080 THAT HELPS PATIENTS, THERE'S 1556 01:00:34,080 --> 01:00:35,960 REALLY GREAT EXCITEMENT IN HOW 1557 01:00:35,960 --> 01:00:40,880 THIS CAN DRIVE FURTHER PROGRESS 1558 01:00:40,880 --> 01:00:42,240 IN IMPROVING HIV TREATMENT 1559 01:00:42,240 --> 01:00:45,200 OVERALL. 1560 01:00:45,200 --> 01:00:47,720 FIRST, THE LONG LASTING 1561 01:00:47,720 --> 01:00:48,480 PHARMACOKINETICS OF THE DRUG 1562 01:00:48,480 --> 01:00:53,000 ALLOW FOR SIX HAD BEEN MONTH SID 1563 01:00:53,000 --> 01:00:55,200 THAT WILL FACILITATE ADHERENCE 1564 01:00:55,200 --> 01:00:55,880 AND VIRAL SUPPRESSION IN 1565 01:00:55,880 --> 01:00:58,320 PATIENTS WHO HAVE A HARD TIME OR 1566 01:00:58,320 --> 01:01:00,480 DIFFICULTY ADHERING TO DAILY 1567 01:01:00,480 --> 01:01:01,360 REGIMENS, AS WELL AS FOR 1568 01:01:01,360 --> 01:01:02,480 PEDIATRIC PATIENTS AND YOUNG 1569 01:01:02,480 --> 01:01:03,440 ADULTS. 1570 01:01:03,440 --> 01:01:07,880 AND PERHAPS JUST AS EXCITINGLY, 1571 01:01:07,880 --> 01:01:09,400 IT HAS REALLY AWESOME POTENTIAL 1572 01:01:09,400 --> 01:01:10,400 IN PREP APPLICATIONS. 1573 01:01:10,400 --> 01:01:11,960 YOU CAN ENVISION THAT ITS 1574 01:01:11,960 --> 01:01:13,200 LONGEVITY WOULD ALLOW TO HAVE 1575 01:01:13,200 --> 01:01:15,280 ALMOST LIKE A VACCINE TO PREVENT 1576 01:01:15,280 --> 01:01:16,720 TRANSCRIPTION, EVEN IN AREAS AND 1577 01:01:16,720 --> 01:01:17,960 IN POPULATIONS WHERE THERE ARE 1578 01:01:17,960 --> 01:01:21,040 HIGH RATES OF RESISTANCE TO ORAL 1579 01:01:21,040 --> 01:01:22,160 REGIMENS. 1580 01:01:22,160 --> 01:01:24,760 THIS IS DEFINITELY A STORY TO 1581 01:01:24,760 --> 01:01:25,000 FOLLOW. 1582 01:01:25,000 --> 01:01:27,400 THE IDEA OF A SUBCUTANEOUS 1583 01:01:27,400 --> 01:01:29,040 INJECTION TWICE A YEAR AS EITHER 1584 01:01:29,040 --> 01:01:30,280 TREATMENT OR FOR PREVENTION 1585 01:01:30,280 --> 01:01:33,360 COULD REALLY BE -- HAVE AN 1586 01:01:33,360 --> 01:01:36,320 IMPORTANT IMPACT. 1587 01:01:36,320 --> 01:01:36,680 OKAY. 1588 01:01:36,680 --> 01:01:37,880 SO NOW THE NEXT AREA THAT I'D 1589 01:01:37,880 --> 01:01:40,960 LIKE TO TOUCH ON IS HIV CURE. 1590 01:01:40,960 --> 01:01:43,000 THIS IS AN AREA WHERE WE HAVE 1591 01:01:43,000 --> 01:01:44,040 FOSTERED COLLABORATIONS ON MANY 1592 01:01:44,040 --> 01:01:46,800 LEVELS, INCLUDING WITH THE IAS 1593 01:01:46,800 --> 01:01:49,240 AND WITH THE BILL AND MELINDA 1594 01:01:49,240 --> 01:01:51,200 GATES FOUNDATION, AS WELL AS 1595 01:01:51,200 --> 01:01:55,520 AMONG OUR GRANTEES. 1596 01:01:55,520 --> 01:01:57,040 THE MARTIN DELANEY 1597 01:01:57,040 --> 01:01:58,320 COLLABORATORIES REPRESENT OUR 1598 01:01:58,320 --> 01:01:58,720 FLAGSHIP PROGRAM. 1599 01:01:58,720 --> 01:02:01,720 WE NOW HAVE 10 MARTIN DELANEY 1600 01:02:01,720 --> 01:02:02,960 COLLABORATORIES UP AND RUNNING, 1601 01:02:02,960 --> 01:02:05,040 WITH NEW BLOOD AND GREAT ENERGY. 1602 01:02:05,040 --> 01:02:06,960 AND I WILL FOCUS NOW FOR JUST A 1603 01:02:06,960 --> 01:02:08,640 MOMENT ON WORK THAT HAS COME OUT 1604 01:02:08,640 --> 01:02:11,320 OF THE DARE COLLABORATORY. 1605 01:02:11,320 --> 01:02:14,680 SO AS WE ALL KNOW, HIV HIDES IN 1606 01:02:14,680 --> 01:02:15,200 THE HUMAN GENOME. 1607 01:02:15,200 --> 01:02:17,040 IT'S LIKE A NEEDLE IN A 1608 01:02:17,040 --> 01:02:17,400 HAYSTACK. 1609 01:02:17,400 --> 01:02:20,040 CELLS THAT ARE LATENTLY AFFECTED 1610 01:02:20,040 --> 01:02:20,880 WITH HIV HAVE TWO 1611 01:02:20,880 --> 01:02:22,360 CHARACTERISTICS THAT MAKE THEM 1612 01:02:22,360 --> 01:02:23,880 INCREDIBLY DIFFICULT TO STUDY. 1613 01:02:23,880 --> 01:02:25,920 ONE, THEY HAVE NO DISTINGUISHING 1614 01:02:25,920 --> 01:02:27,680 MARKERS ON THEIR SURFACE, AND 1615 01:02:27,680 --> 01:02:30,080 TWO, THEY'RE VERY, VERY RARE. 1616 01:02:30,080 --> 01:02:32,120 AMONG MEMORY CELLS, AS SHOWN 1617 01:02:32,120 --> 01:02:33,880 HERE, THESE ARE A THOUSAND CELLS 1618 01:02:33,880 --> 01:02:38,280 ON THIS SCREEN, ABOUT 1 IN A 1619 01:02:38,280 --> 01:02:40,840 THOUSAND HAVE SOME INTEGRATED 1620 01:02:40,840 --> 01:02:41,520 HIV DNA. 1621 01:02:41,520 --> 01:02:43,720 A THOUSAND TIMES RARER, ABOUT 1622 01:02:43,720 --> 01:02:48,120 1 IN A MILLION, HAVE ACTUALLY 1623 01:02:48,120 --> 01:02:48,800 REPLICATION-COMPETENT PRO VIRUS. 1624 01:02:48,800 --> 01:02:51,640 SO THIS MAKES IT ESSENTIALLY 1625 01:02:51,640 --> 01:02:52,680 IMPOSSIBLE TO SEPARATE CELLS 1626 01:02:52,680 --> 01:02:55,760 WITH LATENT HIV FROM THEIR 1627 01:02:55,760 --> 01:02:56,480 UNINFECTED COUNTERPARTS, AND 1628 01:02:56,480 --> 01:02:58,160 THIS IS A PROBLEM THAT HAS 1629 01:02:58,160 --> 01:02:59,880 PLAGUED THE FIELD SINCE WHEN I 1630 01:02:59,880 --> 01:03:02,000 WAS IN THE LAB WORKING ON THIS 1631 01:03:02,000 --> 01:03:03,800 30 YEARS AGO. 1632 01:03:03,800 --> 01:03:06,520 BUT WE ARE CAREFULLY AND 1633 01:03:06,520 --> 01:03:09,000 METHODOLOGICALLY REALLY HONING 1634 01:03:09,000 --> 01:03:10,640 IN ON CHARACTERISTICS AND 1635 01:03:10,640 --> 01:03:12,400 BEHAVIORS OF LATENTLY INFECTED 1636 01:03:12,400 --> 01:03:14,160 CELLS, AND SOME OF YOU WILL 1637 01:03:14,160 --> 01:03:17,160 RECALL THAT LAST YEAR I TALKED 1638 01:03:17,160 --> 01:03:18,360 ABOUT CLONAL PROLIFERATION OF 1639 01:03:18,360 --> 01:03:22,000 THESE CELLS. 1640 01:03:22,000 --> 01:03:23,400 AND NOW HERE I WILL DESCRIBE A 1641 01:03:23,400 --> 01:03:24,760 NEW TECHNOLOGY FROM A VERY 1642 01:03:24,760 --> 01:03:26,120 RECENTLY PUBLISHED PAPER THAT 1643 01:03:26,120 --> 01:03:31,560 DIRECTLY ADDRESSES THIS PROBLEM 1644 01:03:31,560 --> 01:03:34,080 USING FOCUSED INTERROGATION OF 1645 01:03:34,080 --> 01:03:36,120 CELLS BY NUCLEIC ACID DETECTION 1646 01:03:36,120 --> 01:03:38,360 AND SEQUENCING, FIND-SEQ. 1647 01:03:38,360 --> 01:03:39,520 THIS IS A COMPLICATED SLIDE BUT 1648 01:03:39,520 --> 01:03:41,720 IF YOU FOLLOW ME THROUGH IT ON A 1649 01:03:41,720 --> 01:03:42,880 SUPERFICIAL LEVEL FROM LEFT TO 1650 01:03:42,880 --> 01:03:43,840 RIGHT, IT'S ESSENTIALLY 1651 01:03:43,840 --> 01:03:46,120 TECHNOLOGY THAT USES FOUR STEPS 1652 01:03:46,120 --> 01:03:48,760 TO ANALYZE GENETIC INFORMATION 1653 01:03:48,760 --> 01:03:51,400 FROM INDIVIDUAL CELLS. 1654 01:03:51,400 --> 01:03:52,960 FROM FAR LEFT, FIRST CELLS ARE 1655 01:03:52,960 --> 01:03:57,800 FUNNELED INTO A MICRO FLUIDIC 1656 01:03:57,800 --> 01:04:01,040 DEVICE, LOADS AND LEISTS 1657 01:04:01,040 --> 01:04:02,440 INDIVIDUAL CELLS AND RETAINS THE 1658 01:04:02,440 --> 01:04:03,840 GENETIC MATERIAL IN INDIVIDUAL 1659 01:04:03,840 --> 01:04:07,040 DROPLETS. 1660 01:04:07,040 --> 01:04:08,720 NEXT, PCR IS USED TO AMPLIFY 1661 01:04:08,720 --> 01:04:12,920 GENES THAT ARE EXPRESSED. 1662 01:04:12,920 --> 01:04:14,760 THE THIRD STEP, HIV DNA, IS 1663 01:04:14,760 --> 01:04:17,200 LABELED AND IN THE FOURTH, A 1664 01:04:17,200 --> 01:04:22,040 LASER IS USED TO SORT 1665 01:04:22,040 --> 01:04:23,040 FLUORESCENT DROPLETS THAT HAVE 1666 01:04:23,040 --> 01:04:26,400 HIV DNA FROM ONES THAT DON'T. 1667 01:04:26,400 --> 01:04:30,360 ONCE SORTED, THE DROPLETS CAN BE 1668 01:04:30,360 --> 01:04:31,840 ANALYZED FOR GENE EXPRESSION 1669 01:04:31,840 --> 01:04:32,440 PATTERNS. 1670 01:04:32,440 --> 01:04:34,240 USING THIS TECHNOLOGY, WE ARE 1671 01:04:34,240 --> 01:04:36,840 CATCHING THE VERY FIRST GLIMPSES 1672 01:04:36,840 --> 01:04:41,280 OF SIGNATURES OF LATENCY. 1673 01:04:41,280 --> 01:04:43,920 CLARKE ET AL. FOUND THAT HIV 1674 01:04:43,920 --> 01:04:45,920 INFECTED CELL TRANSCRIPTOMES 1675 01:04:45,920 --> 01:04:48,720 INCLUDED INHIBITION OF CELL 1676 01:04:48,720 --> 01:04:50,960 DEATH, INHIBITION OF 1677 01:04:50,960 --> 01:04:52,840 ANTIPROLIFERATIVE SIGNALING, AND 1678 01:04:52,840 --> 01:04:56,960 SIGNATURES OF HIV SILENCING. 1679 01:04:56,960 --> 01:04:58,280 NOW, THEY DEVELOPED THIS 1680 01:04:58,280 --> 01:05:01,200 TECHNOLOGY SPECIFICALLY FOR HIV, 1681 01:05:01,200 --> 01:05:02,520 BUT REALLY INTERESTINGLY, THEY 1682 01:05:02,520 --> 01:05:04,400 WERE ABLE TO APPLY THIS 1683 01:05:04,400 --> 01:05:06,680 TECHNOLOGY TO AN ENTIRELY 1684 01:05:06,680 --> 01:05:07,440 DIFFERENT DISEASE. 1685 01:05:07,440 --> 01:05:09,480 HERE THEY USE THE TECHNOLOGY TO 1686 01:05:09,480 --> 01:05:11,560 MAKE AN IMPORTANT DISCOVERY ON 1687 01:05:11,560 --> 01:05:13,440 MULTIPLE SCLEROSIS, WHERE THEY 1688 01:05:13,440 --> 01:05:17,000 HAVE IDENTIFIED A NEW ROLE FOR 1689 01:05:17,000 --> 01:05:19,720 GENE INVOLVED IN PATHOGENIC 1690 01:05:19,720 --> 01:05:21,720 ASTROCYTE RESPONSES, REVEALING A 1691 01:05:21,720 --> 01:05:22,840 THERAPEUTICALLY TARGETABLE 1692 01:05:22,840 --> 01:05:24,480 MECHANISM TO TREAT PEOPLE WHO 1693 01:05:24,480 --> 01:05:28,320 HAVE MULTIPLE SCLEROSIS. 1694 01:05:28,320 --> 01:05:29,200 OKAY. 1695 01:05:29,200 --> 01:05:32,960 SO NOW SHIFTING TO ENDING THE 1696 01:05:32,960 --> 01:05:35,920 HIV EPIDEMIC, OUR CENTERS FOR 1697 01:05:35,920 --> 01:05:37,360 AIDS RESEARCH AND ON THE HUMAN 1698 01:05:37,360 --> 01:05:41,600 SCALE OF RESEARCH, IN FEBRUARY 1699 01:05:41,600 --> 01:05:42,920 OF 2019, THE WHITE HOUSE 1700 01:05:42,920 --> 01:05:44,760 ANNOUNCED AN INITIATIVE TO END 1701 01:05:44,760 --> 01:05:47,520 THE HIV EPIDEMIC. 1702 01:05:47,520 --> 01:05:49,880 DR. FAUCI WAS, OF COURSE, BEHIND 1703 01:05:49,880 --> 01:05:52,480 THIS, AND THE SCIENCE ARTICLE BY 1704 01:05:52,480 --> 01:05:54,600 JOHN COHEN NICELY EXPLAINS HOW 1705 01:05:54,600 --> 01:05:57,040 DR. FAUCI GOT US INVOLVED. 1706 01:05:57,040 --> 01:06:00,000 HE STATED THAT THE CFARs, 1707 01:06:00,000 --> 01:06:02,560 MAINLY BASED AT UNIVERSITIES, 1708 01:06:02,560 --> 01:06:03,400 CONDUCT MULTIDISCIPLINARY 1709 01:06:03,400 --> 01:06:05,600 STUDIES INCLUDING ON HOW BEST TO 1710 01:06:05,600 --> 01:06:07,840 KEEP HIV INFECTED PEOPLE IN CARE 1711 01:06:07,840 --> 01:06:09,960 AND HELP UNINFECTED PEOPLE 1712 01:06:09,960 --> 01:06:12,800 ACCESS PROVEN INTERVENTIONS. 1713 01:06:12,800 --> 01:06:16,680 THE LOCATION OF THE 19 CFARs 1714 01:06:16,680 --> 01:06:17,840 BEAUTIFULLY OVERLAP, ALTHOUGH 1715 01:06:17,840 --> 01:06:18,640 NOT COMPLETELY, WITH THE HOT 1716 01:06:18,640 --> 01:06:19,080 SPOTS. 1717 01:06:19,080 --> 01:06:21,200 HE ALSO EMPHASIZED THAT THE 1718 01:06:21,200 --> 01:06:23,160 CFARs HAVE STRONG TIES TO 1719 01:06:23,160 --> 01:06:24,920 THEIR COMMUNITIES, AND THEY CAN 1720 01:06:24,920 --> 01:06:26,440 BETTER COORDINATE HOW THEY WORK 1721 01:06:26,440 --> 01:06:27,720 TOGETHER TO PREVENT NEW 1722 01:06:27,720 --> 01:06:29,000 INFECTIONS. 1723 01:06:29,000 --> 01:06:33,360 SO THEN JUMPING IN IMMEDIATELY 1724 01:06:33,360 --> 01:06:34,520 IN 2019 IN COLLABORATION WITH 1725 01:06:34,520 --> 01:06:36,000 OUR COLLEAGUES AT THE NATIONAL 1726 01:06:36,000 --> 01:06:37,200 INSTITUTE OF MENTAL HEALTH, WE 1727 01:06:37,200 --> 01:06:40,480 CHOSE TOPICS FOR OUR CFARs AND 1728 01:06:40,480 --> 01:06:42,800 AIDS RESEARCH CENTERS THAT COULD 1729 01:06:42,800 --> 01:06:46,120 HELP US ALIGN, COLLABORATE, AND 1730 01:06:46,120 --> 01:06:48,320 GUIDE THE CDC AND HRSA EFFORTS 1731 01:06:48,320 --> 01:06:50,640 WITH IMPLEMENTATION SCIENCE 1732 01:06:50,640 --> 01:06:52,280 STUDIES TOWARDS TREATMENT AND 1733 01:06:52,280 --> 01:06:55,160 PREVENTION OF HIV INFECTION. 1734 01:06:55,160 --> 01:06:56,680 THIS TABLE SUMMARIZES THE LARGE 1735 01:06:56,680 --> 01:06:58,840 NUMBER OF PROJECTS AND THE 1736 01:06:58,840 --> 01:07:00,120 GENERAL FOCUS FOR EACH OF THESE 1737 01:07:00,120 --> 01:07:03,040 AREAS. 1738 01:07:03,040 --> 01:07:07,720 AND NEXT HERE IS -- THIS SPECIAL 1739 01:07:07,720 --> 01:07:10,440 ISSUE REPORTED FINDINGS FROM THE 1740 01:07:10,440 --> 01:07:14,040 EHE SUPPLEMENT PROJECTS AS WELL 1741 01:07:14,040 --> 01:07:17,400 AS LARGER DOMESTIC RESEARCH 1742 01:07:17,400 --> 01:07:18,760 STUDIES FUNDED BY THE NIH. 1743 01:07:18,760 --> 01:07:20,800 THE ARTICLES INCLUDED HERE COVER 1744 01:07:20,800 --> 01:07:21,840 ALL GEOGRAPHIC REGIONS IN THE 1745 01:07:21,840 --> 01:07:23,360 UNITED STATES, INCLUDING URBAN 1746 01:07:23,360 --> 01:07:25,240 AS WELL AS RURAL LOCATIONS, AND 1747 01:07:25,240 --> 01:07:29,080 FOCUS ON PRIORITY POPULATIONS, 1748 01:07:29,080 --> 01:07:31,440 INCLUDING SEXUAL MINORITY MEN, 1749 01:07:31,440 --> 01:07:33,200 TRANSGENDER PEOPLE, AND BLACK 1750 01:07:33,200 --> 01:07:39,440 AND LATINA CISGENDER WOMEN. 1751 01:07:39,440 --> 01:07:40,560 SO SPEAKING OF WOMEN, SEVERAL 1752 01:07:40,560 --> 01:07:41,680 YEARS AGO, WE HAD A DISCUSSION 1753 01:07:41,680 --> 01:07:43,240 HERE IN THIS MEETING WHEN WE 1754 01:07:43,240 --> 01:07:44,560 WERE STILL ALL TOGETHER IN THE 1755 01:07:44,560 --> 01:07:46,440 SAME ROOM ABOUT THE DIFFICULTIES 1756 01:07:46,440 --> 01:07:48,240 OF STUDYING WOMEN WHO ARE AT 1757 01:07:48,240 --> 01:07:49,800 RISK OF BECOMING INFECTED. 1758 01:07:49,800 --> 01:07:52,360 WE ARE EMBARKING ON THE LIGHT 1759 01:07:52,360 --> 01:07:53,640 STUDIES WHICH USE SOCIAL MEDIA 1760 01:07:53,640 --> 01:07:55,320 AND DATING APPS TO REACH MOSTLY 1761 01:07:55,320 --> 01:07:57,040 MEN WHO HAVE SEX WITH MEN. 1762 01:07:57,040 --> 01:07:58,880 SOMEONE HERE PRESSED US TO FOCUS 1763 01:07:58,880 --> 01:08:00,880 MORE ON WOMEN, AND WOMEN WHO 1764 01:08:00,880 --> 01:08:03,200 WERE AT RISK OF INFECTION. 1765 01:08:03,200 --> 01:08:05,480 SO THIS ANNOUNCEMENT CAME OUT IN 1766 01:08:05,480 --> 01:08:07,600 2021. 1767 01:08:07,600 --> 01:08:09,680 AND WE HAVE JUST RECENTLY BEEN 1768 01:08:09,680 --> 01:08:12,040 ABLE TO FUND THREE GROUPS THAT 1769 01:08:12,040 --> 01:08:14,080 COMBINE EPIDEMIOLOGIC METHODS, 1770 01:08:14,080 --> 01:08:15,560 DIGITAL TECHNOLOGY, AND DATA 1771 01:08:15,560 --> 01:08:17,360 SCIENCE APPROACHES TO BETTER 1772 01:08:17,360 --> 01:08:20,640 UNDERSTAND HIV PREVENTION, 1773 01:08:20,640 --> 01:08:22,200 TRANSMISSION, AND EARLY CARE 1774 01:08:22,200 --> 01:08:23,600 CASCADE POINTS FOR WOMEN LIVING 1775 01:08:23,600 --> 01:08:26,200 IN THE UNITED STATES. 1776 01:08:26,200 --> 01:08:28,040 ALL OF THESE PROJECTS ARE LED BY 1777 01:08:28,040 --> 01:08:30,760 WOMEN INVESTIGATORS, AND FOCUS 1778 01:08:30,760 --> 01:08:32,840 ON AT RISK WOMEN. 1779 01:08:32,840 --> 01:08:34,560 SO NOW JUST TO GIVE A LITTLE 1780 01:08:34,560 --> 01:08:37,480 PREVIEW OF THE WORK FROM ONE OF 1781 01:08:37,480 --> 01:08:42,920 THESE GROUPS, ANDREA WORTZ AND 1782 01:08:42,920 --> 01:08:44,440 COLLEAGUES WORKING WITH 1783 01:08:44,440 --> 01:08:46,760 TRANSGENDER WOMEN PRESENTED AT 1784 01:08:46,760 --> 01:08:48,760 AIDS 2022 IN MONTREAL. 1785 01:08:48,760 --> 01:08:53,240 WE ALL NO KNOW THAT TRANSGENDER 1786 01:08:53,240 --> 01:08:54,480 WOMEN ARE AT HIGHER RISK BUT 1787 01:08:54,480 --> 01:08:56,280 THEY HAVE ENROLLED THE FIRST 1788 01:08:56,280 --> 01:08:58,480 MULTISITE COHORT TO ESTIMATE HIV 1789 01:08:58,480 --> 01:09:00,440 INCIDENCE IN TRANSGENDER WOMEN 1790 01:09:00,440 --> 01:09:04,240 LIVING IN THE UNITED STATES. 1791 01:09:04,240 --> 01:09:06,040 THEIR PAPER IS UNDER EMBARGO SO 1792 01:09:06,040 --> 01:09:07,240 WE CAN'T DISCUSS THE DETAILS, 1793 01:09:07,240 --> 01:09:08,440 BUT THEY REPORT SIGNIFICANTLY 1794 01:09:08,440 --> 01:09:10,240 HIGHER RATES OF HIV INCIDENCE 1795 01:09:10,240 --> 01:09:12,960 AMONG BLACK PARTICIPANTS, AND 1796 01:09:12,960 --> 01:09:14,600 SIGNIFICANTLY HIGHER MORTALITY 1797 01:09:14,600 --> 01:09:16,400 RATES IN HISPANIC POPULATIONS. 1798 01:09:16,400 --> 01:09:18,840 THE PAPER WILL BE COMING OUT 1799 01:09:18,840 --> 01:09:22,920 SOON IN LANCET HIV, SO STAY 1800 01:09:22,920 --> 01:09:23,680 TUNED FOR THAT. 1801 01:09:23,680 --> 01:09:26,360 SO NOW WRAPPING UP AND COMING TO 1802 01:09:26,360 --> 01:09:28,000 FUTURE DIRECTIONS, AS I 1803 01:09:28,000 --> 01:09:30,400 MENTIONED EARLIER, THE DEPTH OF 1804 01:09:30,400 --> 01:09:32,680 KNOWLEDGE THAT WE HAVE GAINED 1805 01:09:32,680 --> 01:09:35,240 THROUGH HIV IS TREMENDOUS. 1806 01:09:35,240 --> 01:09:37,520 IN OUR BASIC SCIENCES AND 1807 01:09:37,520 --> 01:09:39,080 TARGETED INTERVENTIONS BRANCHES, 1808 01:09:39,080 --> 01:09:41,720 OUR INITIATIVES WILL FOCUS ON 1809 01:09:41,720 --> 01:09:43,200 FURTHER DEEPENING KNOWLEDGE AND 1810 01:09:43,200 --> 01:09:45,120 FOCUSING ON DETAILS OF THE PRO 1811 01:09:45,120 --> 01:09:47,840 VIRUS, THE VIRUS, AND HOW TO 1812 01:09:47,840 --> 01:09:50,120 TARGET IT VERY SPECIFICALLY BY 1813 01:09:50,120 --> 01:09:52,320 THE IMMUNE SYSTEM, WHERE EVEN 1814 01:09:52,320 --> 01:09:54,920 THE SMALLEST CHANGES CAN MAKE A 1815 01:09:54,920 --> 01:09:56,080 BIG DIFFERENCE IN WHAT IS 1816 01:09:56,080 --> 01:09:56,880 RECOGNIZED. 1817 01:09:56,880 --> 01:09:59,200 SO WE ARE LOOKING TO FURTHER 1818 01:09:59,200 --> 01:10:01,640 CLOSING IN ON OUR TARGET OF THE 1819 01:10:01,640 --> 01:10:05,400 HIV PRO VIRUS. 1820 01:10:05,400 --> 01:10:06,800 AS FAR AS LESSONS LEARNED WITH 1821 01:10:06,800 --> 01:10:09,520 COVID, WE HAVE LEARNED THAT 1822 01:10:09,520 --> 01:10:10,800 LEVERAGING WHAT WE HAVE LEARNED 1823 01:10:10,800 --> 01:10:13,200 THROUGH HIV HAS BEEN EXTREMELY 1824 01:10:13,200 --> 01:10:16,600 USEFUL SCIENTIFICALLY IN 1825 01:10:16,600 --> 01:10:18,080 COMBATING SARS FROM, AS I 1826 01:10:18,080 --> 01:10:18,960 MENTIONED EARLIER, DETERMINING 1827 01:10:18,960 --> 01:10:21,040 THE STRUCTURE OF SPIKE TO 1828 01:10:21,040 --> 01:10:23,320 DESIGNING MRNA VACCINES. 1829 01:10:23,320 --> 01:10:27,360 THE CHALLENGES HAVE MORE TO DO 1830 01:10:27,360 --> 01:10:28,680 WITHDRAWING FUNDING LINES, AS 1831 01:10:28,680 --> 01:10:32,720 CARL MENTIONED EARLIER. 1832 01:10:32,720 --> 01:10:34,600 EVERYBODY OF OUR GRANTEES WAS 1833 01:10:34,600 --> 01:10:36,320 VERY EAGER TO HELP SOLVE COVID, 1834 01:10:36,320 --> 01:10:37,960 BUT FUNDING LINES HAD TO BE 1835 01:10:37,960 --> 01:10:42,040 DRAWN. 1836 01:10:42,040 --> 01:10:44,040 SIMILARLY, IN EPIDEMIOLOGY AND 1837 01:10:44,040 --> 01:10:45,680 ENDING THE HIV EPIDEMIC, WE ALSO 1838 01:10:45,680 --> 01:10:46,960 AIMED TO GET A DEEPER 1839 01:10:46,960 --> 01:10:48,120 UNDERSTANDING OF WHAT IS 1840 01:10:48,120 --> 01:10:50,480 HAPPENING ON THE LEVEL OF THE 1841 01:10:50,480 --> 01:10:51,640 INDIVIDUAL, TRYING TO REACH 1842 01:10:51,640 --> 01:10:53,480 PEOPLE MORE DIRECTLY, 1843 01:10:53,480 --> 01:10:55,560 UNDERSTANDING INTERPERSONAL 1844 01:10:55,560 --> 01:10:57,480 DYNAMICS IN AT-RISK POPULATIONS 1845 01:10:57,480 --> 01:10:58,880 AND LEADING IMPLEMENTATION 1846 01:10:58,880 --> 01:11:00,200 SCIENCE STUDIES TO PROTECT OUR 1847 01:11:00,200 --> 01:11:01,320 PEOPLE USING EFFECTIVE 1848 01:11:01,320 --> 01:11:04,480 STRATEGIES. 1849 01:11:04,480 --> 01:11:06,840 IN TERMS OF LESSONS LEARNED, THE 1850 01:11:06,840 --> 01:11:10,040 DOMESTIC AND WORLDWIDE NETWORK 1851 01:11:10,040 --> 01:11:13,120 OF HIV RESEARCHERS CONTRIBUTED 1852 01:11:13,120 --> 01:11:14,760 IMMENSELY TO THE RABID RESPONSE 1853 01:11:14,760 --> 01:11:15,040 OF COVID. 1854 01:11:15,040 --> 01:11:16,680 IF WE CANNOT LEVERAGE OUR 1855 01:11:16,680 --> 01:11:17,920 RESOURCES, WE CAN CERTAINLY 1856 01:11:17,920 --> 01:11:19,600 CONTINUE TO LEVERAGE THROUGH 1857 01:11:19,600 --> 01:11:21,320 BASIC SCIENCE AND THROUGH ALL OF 1858 01:11:21,320 --> 01:11:23,960 OUR INTERPERSONAL COLLABORATIONS 1859 01:11:23,960 --> 01:11:26,680 AND CONNECTIONS DOMESTICALLY AND 1860 01:11:26,680 --> 01:11:28,280 ABROAD. 1861 01:11:28,280 --> 01:11:31,080 SO I WILL END BY THANKING ALL OF 1862 01:11:31,080 --> 01:11:33,480 MY COLLEAGUES IN BSP FOR THE 1863 01:11:33,480 --> 01:11:35,400 WORK THAT WE'VE BEEN DOING 1864 01:11:35,400 --> 01:11:37,920 TOGETHER, ESPECIALLY OVER THESE 1865 01:11:37,920 --> 01:11:39,240 PAST THREE YEARS, AND I ALSO 1866 01:11:39,240 --> 01:11:41,800 WANT TO THANK YOU ALL FOR YOUR 1867 01:11:41,800 --> 01:11:42,800 ATTENTION, AND I'M HAPPY TO 1868 01:11:42,800 --> 01:11:47,280 ANSWER ANY QUESTIONS. 1869 01:11:47,280 --> 01:11:51,040 AND I'LL TRY TO STOP SHARING. 1870 01:11:51,040 --> 01:11:52,720 >>THANK YOU, DR. FINZI. 1871 01:11:52,720 --> 01:11:54,360 YOU SHOWED SOME BEAUTIFUL 1872 01:11:54,360 --> 01:11:55,800 PICTURES AND SOME EVEN MORE 1873 01:11:55,800 --> 01:11:57,200 BEAUTIFUL SCIENCE, SO THAT WAS 1874 01:11:57,200 --> 01:11:59,240 REALLY FA FANTASTIC. 1875 01:11:59,240 --> 01:12:00,000 >>JUST ONE SECOND. 1876 01:12:00,000 --> 01:12:01,960 DID I CALL YOU DR. FRIEDMAN? 1877 01:12:01,960 --> 01:12:03,480 BECAUSE WE HAVE VERY CLOSE 1878 01:12:03,480 --> 01:12:04,280 FRIENDS. 1879 01:12:04,280 --> 01:12:04,840 >>WHATEVER. 1880 01:12:04,840 --> 01:12:07,000 >>I THINK I SAID FRIEDMAN 1881 01:12:07,000 --> 01:12:08,840 INSTEAD OF FREEDBERG. 1882 01:12:08,840 --> 01:12:11,240 BUT OF COURSE I KNOW YOU'RE YOU. 1883 01:12:11,240 --> 01:12:12,640 >>THAT'S FINE. 1884 01:12:12,640 --> 01:12:16,480 YES, I AM DEFINITELY ME. 1885 01:12:16,480 --> 01:12:18,800 ALTHOUGH I GO BY STANLEY TUCCI 1886 01:12:18,800 --> 01:12:20,760 ON OCCASION. 1887 01:12:20,760 --> 01:12:28,400 SO, QUESTIONS. 1888 01:12:28,400 --> 01:12:30,240 >>DIANA, I HAVE A QUESTION. 1889 01:12:30,240 --> 01:12:33,040 IT'S MAYBE NOT TOO SCIENTIFIC, 1890 01:12:33,040 --> 01:12:35,800 BUT THE LENACAPAVIR STORY IS 1891 01:12:35,800 --> 01:12:37,960 FANTASTIC, SUPER EXCITING, 1892 01:12:37,960 --> 01:12:39,720 WONDERFUL DRUG THAT'S GOING TO 1893 01:12:39,720 --> 01:12:42,440 COST $40,000 A PATIENT A YEAR IN 1894 01:12:42,440 --> 01:12:44,000 PROJECTED SALES OR $4 BILLION A 1895 01:12:44,000 --> 01:12:44,360 YEAR. 1896 01:12:44,360 --> 01:12:45,920 SO, YOU KNOW, YOU SAID THIS IS 1897 01:12:45,920 --> 01:12:47,080 THIS WONDERFUL COLLABORATION 1898 01:12:47,080 --> 01:12:48,960 BETWEEN THE GOVERNMENT, ACADEMIA 1899 01:12:48,960 --> 01:12:51,400 AND PHARMA. 1900 01:12:51,400 --> 01:12:52,240 OBVIOUSLY DRUG PRICES ARE 1901 01:12:52,240 --> 01:12:53,640 GETTING MORE AND MORE ATTENTION 1902 01:12:53,640 --> 01:12:56,200 AS THE YEARS ARE GOING ALONG. 1903 01:12:56,200 --> 01:12:57,160 I DON'T KNOW. 1904 01:12:57,160 --> 01:13:00,080 YOU KNOW, IS THAT EVEN A PART OF 1905 01:13:00,080 --> 01:13:03,120 WHAT YOU CONSIDER AS THESE 1906 01:13:03,120 --> 01:13:05,880 PROGRAMS MOVE AHEAD? 1907 01:13:05,880 --> 01:13:06,320 AS SORT OF 1908 01:13:06,320 --> 01:13:07,920 THE PUBLIC ADVOCATES FOR THE 1909 01:13:07,920 --> 01:13:10,000 AMERICAN TAXPAYER? 1910 01:13:10,000 --> 01:13:15,560 >>SO UNFORTUNATELY, OUR JOB IS 1911 01:13:15,560 --> 01:13:17,440 DISCOVERY, RIGHT? 1912 01:13:17,440 --> 01:13:22,000 AND THE BASICS, THE UNDERLYING 1913 01:13:22,000 --> 01:13:22,640 BASICS. 1914 01:13:22,640 --> 01:13:26,680 I AGREE WITH YOU THAT IT'S 1915 01:13:26,680 --> 01:13:31,080 HORRIBLE, BUT THAT REALLY IS -- 1916 01:13:31,080 --> 01:13:32,480 AT LEAST IT'S NOT IN ANY WAY 1917 01:13:32,480 --> 01:13:37,400 ANYTHING I CAN DO ANYTHING 1918 01:13:37,400 --> 01:13:37,920 ABOUT. 1919 01:13:37,920 --> 01:13:38,320 AND PART -- 1920 01:13:38,320 --> 01:13:40,760 >>LET ME MAKE A QUICK COMMENT, 1921 01:13:40,760 --> 01:13:43,080 THAT RIGHT NOW IF I GO DOWN TO 1922 01:13:43,080 --> 01:13:46,680 CVS AND BUY FIRST LINE HIV ORAL 1923 01:13:46,680 --> 01:13:49,680 THERAPY, PAY CASH, IT'S ABOUT 1924 01:13:49,680 --> 01:13:55,720 $48,000 A YEAR, TLD COSTS $42 A 1925 01:13:55,720 --> 01:13:56,560 YEAR, 4-2. 1926 01:13:56,560 --> 01:13:58,520 SO WHAT HAS HAPPENED 1927 01:13:58,520 --> 01:14:01,160 HISTORICALLY WITH HIV DRUGS, IN 1928 01:14:01,160 --> 01:14:03,560 NO OTHER AREA OF MEDICINE, I 1929 01:14:03,560 --> 01:14:05,960 THINK IT IS OUR COLLECTIVE 1930 01:14:05,960 --> 01:14:09,480 SOCIAL AND GLOBAL RESPONSIBILITY 1931 01:14:09,480 --> 01:14:10,880 TO MAKE SURE THAT EFFECTIVE NEW 1932 01:14:10,880 --> 01:14:12,320 DRUGS BECOME AVAILABLE. 1933 01:14:12,320 --> 01:14:16,520 SO LET'S TAKE THAT ON AS PART OF 1934 01:14:16,520 --> 01:14:17,400 OUR AGENDA. 1935 01:14:17,400 --> 01:14:18,320 MONICA HAS A QUESTION. 1936 01:14:18,320 --> 01:14:18,960 >>YES. 1937 01:14:18,960 --> 01:14:20,440 THAT WAS REALLY GREAT. 1938 01:14:20,440 --> 01:14:26,040 I THINK THAT LANGE LONG ACTING O 1939 01:14:26,040 --> 01:14:27,200 EXCITING, I CAN'T EVEN SIT 1940 01:14:27,200 --> 01:14:27,880 STILL. 1941 01:14:27,880 --> 01:14:28,640 LENACAPAVIR, A COUPLE QUESTIONS 1942 01:14:28,640 --> 01:14:30,040 ON SOME OF THE BASIC SCIENCE 1943 01:14:30,040 --> 01:14:31,320 WHICH IS THAT IT IS INTERESTING 1944 01:14:31,320 --> 01:14:34,000 IN THE PICTURE THAT YOU SHOW 1945 01:14:34,000 --> 01:14:35,920 THAT IN A WAY, IT'S THROUGHOUT 1946 01:14:35,920 --> 01:14:37,440 THE LIFECYCLE, IT NOT AT THE 1947 01:14:37,440 --> 01:14:40,200 VERY END, WHERE CAPSID 1948 01:14:40,200 --> 01:14:41,160 INHIBITION OCCURS. 1949 01:14:41,160 --> 01:14:45,080 AND I THINK THAT IS IS REALLY 1950 01:14:45,080 --> 01:14:46,400 HEARTENING IN THE SENSE THAT 1951 01:14:46,400 --> 01:14:48,320 INITIALLY IN THE ECTG, WE WERE 1952 01:14:48,320 --> 01:14:51,920 SAYING WE CAN'T EACH THINK ABOUT 1953 01:14:51,920 --> 01:14:55,600 THIS FOR CURE OR SUPPRESSION OF 1954 01:14:55,600 --> 01:14:56,520 VIREMIA BECAUSE EVERYTHING IS 1955 01:14:56,520 --> 01:14:58,040 GOING TO OCCUR AT THE END, BUT 1956 01:14:58,040 --> 01:15:00,000 TO A VIROLOGIST WHO REALLY 1957 01:15:00,000 --> 01:15:01,600 UNDERSTANDS WHERE LENACAPAVIR IS 1958 01:15:01,600 --> 01:15:03,800 WORKING, APPARENTLY THERE IS A 1959 01:15:03,800 --> 01:15:04,560 POSSIBILITY, AND THIS IS GOING 1960 01:15:04,560 --> 01:15:07,520 TO BE STUDIED IN THE ECTG OF 1961 01:15:07,520 --> 01:15:09,240 REDUCING EVEN LOW GRADE VIRAL 1962 01:15:09,240 --> 01:15:10,040 LOADS. 1963 01:15:10,040 --> 01:15:11,320 YOU KNOW, EVEN IN BETWEEN. 1964 01:15:11,320 --> 01:15:13,720 COULD IT BE REDUCING HIV DNA 1965 01:15:13,720 --> 01:15:17,000 LEVELS, COULD IT BE EVEN IN 1966 01:15:17,000 --> 01:15:17,320 BETWEEN. 1967 01:15:17,320 --> 01:15:18,640 AND I WOULD JUST COMMENT, YOU 1968 01:15:18,640 --> 01:15:20,040 KNOW, ON THE PRICE BECAUSE -- 1969 01:15:20,040 --> 01:15:23,560 ONLY BECAUSE IF WE THOUGHT ABOUT 1970 01:15:23,560 --> 01:15:26,520 THE TDF/FTC TRIALS, AND I THINK 1971 01:15:26,520 --> 01:15:27,560 THIS IS DIFFERENT BUT I'M JUST 1972 01:15:27,560 --> 01:15:30,120 GOING TO ASK YOU THIS DIRECTLY, 1973 01:15:30,120 --> 01:15:32,600 THE REASON THAT THERE WAS 1974 01:15:32,600 --> 01:15:33,600 CONTROVERSY AROUND THE PRICE OF 1975 01:15:33,600 --> 01:15:39,040 THE ORIGINAL TDF/FTC FROM GILEAD 1976 01:15:39,040 --> 01:15:40,400 IS BECAUSE ALL THE CLINICAL 1977 01:15:40,400 --> 01:15:42,160 TRIALS FOR PREP WERE FUNDED BY 1978 01:15:42,160 --> 01:15:45,520 THE NIH. 1979 01:15:45,520 --> 01:15:47,200 SO IPREX, ALL OF THEM WERE 1980 01:15:47,200 --> 01:15:48,560 FUNDED NOT BY THE DRUG COMPANIES 1981 01:15:48,560 --> 01:15:50,120 BUT IT WAS REALLY GOVERNMENTAL 1982 01:15:50,120 --> 01:15:51,160 MONEY THAT FUNDED THE BIG 1983 01:15:51,160 --> 01:15:52,400 CLINICAL TRIALS. 1984 01:15:52,400 --> 01:15:54,400 LENACAPAVIR, THE CAPELLA STUDY 1985 01:15:54,400 --> 01:15:56,320 IS THE ONLY MAJOR ONE, THERE'S 1986 01:15:56,320 --> 01:15:58,960 ALSO CALABRE AND I THINK IT WAS 1987 01:15:58,960 --> 01:16:00,440 FUNDED BY THE DRUG COMPANY. 1988 01:16:00,440 --> 01:16:01,600 IS THAT CORRECT? 1989 01:16:01,600 --> 01:16:04,120 NOT BY -- NOT BY GOVERNMENT. 1990 01:16:04,120 --> 01:16:05,760 SO IT'S NOT EXACTLY THE SAME 1991 01:16:05,760 --> 01:16:07,280 THING AS THE PROTESTS THAT CAME 1992 01:16:07,280 --> 01:16:12,080 ABOUT WITH TDF/FTC PRICING. 1993 01:16:12,080 --> 01:16:15,920 >>SO TO THE FIRST PART OF YOUR 1994 01:16:15,920 --> 01:16:18,240 COMMENT, WHAT'S KIND OF -- SO 1995 01:16:18,240 --> 01:16:21,320 THE MECHANISM, THEY KNOW EXACTLY 1996 01:16:21,320 --> 01:16:25,600 WHERE IT BINDS BECAUSE THEY SEE 1997 01:16:25,600 --> 01:16:28,120 WHERE MUTATIONS MAKE IT 1998 01:16:28,120 --> 01:16:30,280 INEFFECTIVE, RIGHT? 1999 01:16:30,280 --> 01:16:33,880 BUT EXACTLY -- EXACTLY, EXACTLY 2000 01:16:33,880 --> 01:16:36,400 HOW IT'S WORKING IS STILL BEING 2001 01:16:36,400 --> 01:16:37,040 LOOKED AT. 2002 01:16:37,040 --> 01:16:39,000 ONE OF THE MOST INTERESTING 2003 01:16:39,000 --> 01:16:42,440 THINGS IS THAT IT SEEMS TO 2004 01:16:42,440 --> 01:16:47,360 ALMOST ACCELERATE THE FORMATION 2005 01:16:47,360 --> 01:16:53,800 OF THE TWO PARTS, THE HEXAMER 2006 01:16:53,800 --> 01:16:55,720 PART AS THE CORE IS FORMING. 2007 01:16:55,720 --> 01:16:58,280 SO IT'S ALMOST LIKE IT WORKS 2008 01:16:58,280 --> 01:17:00,680 BETTER AND, THEREFORE, CREATES A 2009 01:17:00,680 --> 01:17:02,400 DEFECTIVE PARTICLE. 2010 01:17:02,400 --> 01:17:04,600 SO I MEAN, I THINK WE WILL HEAR 2011 01:17:04,600 --> 01:17:06,720 A LOT ABOUT IT IN TERMS OF THE 2012 01:17:06,720 --> 01:17:08,840 BASIC SCIENCE. 2013 01:17:08,840 --> 01:17:11,360 AS FAR AS THE QUESTION OF THE 2014 01:17:11,360 --> 01:17:14,080 USE AND THE COSTS AND ALL THAT, 2015 01:17:14,080 --> 01:17:17,600 YOU KNOW, AGAIN, THIS IS NOT 2016 01:17:17,600 --> 01:17:19,560 WHAT -- I MEAN, WE DO THE BASIC 2017 01:17:19,560 --> 01:17:21,080 SCIENCE, AND SO THAT'S REALLY 2018 01:17:21,080 --> 01:17:23,160 OUT OF OUR HANDS. 2019 01:17:23,160 --> 01:17:26,520 I COMPLETELY, COMPLETELY AGREE 2020 01:17:26,520 --> 01:17:27,880 THAT IT'S A TRAVESTY, BUT I 2021 01:17:27,880 --> 01:17:29,000 THINK IT'S A POLITICAL QUESTION 2022 01:17:29,000 --> 01:17:31,320 AND NOT A PERSONAL ONE, AND NOT 2023 01:17:31,320 --> 01:17:34,640 REALLY A QUESTION FOR THE WORK 2024 01:17:34,640 --> 01:17:37,160 THAT WE'RE DOING, UNFORTUNATELY. 2025 01:17:37,160 --> 01:17:40,160 >>THANK YOU, DR. FINZI. 2026 01:17:40,160 --> 01:17:49,320 LAST QUESTION, DR. D D'AQUILA. 2027 01:17:49,320 --> 01:17:51,320 >>THANK YOU. 2028 01:17:51,320 --> 01:17:54,400 MORE GENERIC BUT PROMPTED BY THE 2029 01:17:54,400 --> 01:17:55,600 FINE-SEQ ASSAY AND THOSE 2030 01:17:55,600 --> 01:17:56,880 FINDINGS, YOU KNOW, REFLECTING 2031 01:17:56,880 --> 01:17:59,080 BACK ON ALL WE'VE ACCOMPLISHED, 2032 01:17:59,080 --> 01:18:02,040 DAIDS HAD AN AWFUL LOT TO DO 2033 01:18:02,040 --> 01:18:06,160 WITH DEVELOPING AND ENABLING 2034 01:18:06,160 --> 01:18:07,040 CLINICAL INTRODUCTION OF OUR 2035 01:18:07,040 --> 01:18:09,960 VIRAL LOAD ASSAYS, OUR 2036 01:18:09,960 --> 01:18:12,480 OLD-FASHIONED RESISTANCE 2037 01:18:12,480 --> 01:18:12,960 GENOTYPING, IS THERE ANY 2038 01:18:12,960 --> 01:18:14,560 CONSIDERATION AS ALL THESE NEW 2039 01:18:14,560 --> 01:18:16,160 ASSAYS, IT'S NOT JUST FIND-SEQ, 2040 01:18:16,160 --> 01:18:19,480 WE'RE SEEING THESE KIND OF 2041 01:18:19,480 --> 01:18:19,920 PROLIFERATING. 2042 01:18:19,920 --> 01:18:22,640 AS ALL THESE ARE COMING OUT, 2043 01:18:22,640 --> 01:18:23,840 DOES DAIDS THINK THERE COULD BE 2044 01:18:23,840 --> 01:18:26,120 A WAY TO PROVIDE EITHER CORE 2045 01:18:26,120 --> 01:18:28,840 INFRASTRUCTURE OR TO ENABLE, YOU 2046 01:18:28,840 --> 01:18:30,840 KNOW, SOME OF YOUR NETWORKS, 2047 01:18:30,840 --> 01:18:36,160 MAYBE CFAR, SELFISHLY, TO, YOU 2048 01:18:36,160 --> 01:18:38,360 KNOW, HELP RESEARCHERS GET 2049 01:18:38,360 --> 01:18:41,400 ACCESS TO THESE DIFFICULT AND 2050 01:18:41,400 --> 01:18:42,520 EXPENSIVE ASSAYS, TO PUSH THE 2051 01:18:42,520 --> 01:18:45,560 RESEARCH FASTER. 2052 01:18:45,560 --> 01:18:48,640 >>I THINK THAT'S A REALLY 2053 01:18:48,640 --> 01:18:49,480 INTERESTING QUESTION. 2054 01:18:49,480 --> 01:18:52,160 CARL HAS HIS HAND RAISED. 2055 01:18:52,160 --> 01:18:56,600 >>I THINK, RICH, YOU'RE EXACTLY 2056 01:18:56,600 --> 01:18:57,160 RIGHT. 2057 01:18:57,160 --> 01:18:58,560 THERE'S A PROCESS OF INNOVATION 2058 01:18:58,560 --> 01:19:03,040 FOLLOWED BY IMPLEMENTATION, AND 2059 01:19:03,040 --> 01:19:05,360 HAVE CFAR DECIDE TO BRING IT IN 2060 01:19:05,360 --> 01:19:08,080 AS A CORE WOULD BE A START. 2061 01:19:08,080 --> 01:19:11,480 NETWORKS CAN DIVIDE TO ADD TO 2062 01:19:11,480 --> 01:19:13,000 THEIR TRICKS. 2063 01:19:13,000 --> 01:19:14,720 WE WOULD OF COURSE BE ALWAYS 2064 01:19:14,720 --> 01:19:16,080 INTERESTED IN THIS KIND OF 2065 01:19:16,080 --> 01:19:18,080 INNOVATION AS WE ROLL FORWARD. 2066 01:19:18,080 --> 01:19:19,000 >>THANKS, CARL. 2067 01:19:19,000 --> 01:19:19,440 >>GREAT. 2068 01:19:19,440 --> 01:19:19,960 THANK YOU. 2069 01:19:19,960 --> 01:19:23,240 I'M GOING TO KEEP US MOVING. 2070 01:19:23,240 --> 01:19:24,440 I KNOW THERE ARE A LOT OF 2071 01:19:24,440 --> 01:19:25,440 INTERESTING QUESTIONS AND 2072 01:19:25,440 --> 01:19:26,800 DISCUSSION, BUT I'D LIKE TO 2073 01:19:26,800 --> 01:19:28,360 TURN -- AND THANK YOU, 2074 01:19:28,360 --> 01:19:28,920 DR. FINZI, THAT WAS GREAT. 2075 01:19:28,920 --> 01:19:29,800 >>THANK YOU. 2076 01:19:29,800 --> 01:19:32,840 >> -- TURN IT OVER TO DR. PETER 2077 01:19:32,840 --> 01:19:35,240 KIM, THE THERAPEUTICS RESEARCH 2078 01:19:35,240 --> 01:19:39,200 PROGRAM, AND DR. KIM. 2079 01:19:39,200 --> 01:19:44,960 >>ALL RIGHT. 2080 01:19:44,960 --> 01:19:51,400 WELL, THANK YOU. 2081 01:19:51,400 --> 01:19:52,960 I'LL PRESENT AN UPDATE ON THE 2082 01:19:52,960 --> 01:19:53,760 THERAPEUTICS RESEARCH PROGRAM 2083 01:19:53,760 --> 01:19:54,360 TODAY. 2084 01:19:54,360 --> 01:19:57,880 HOPEFULLY THIS WORKS. 2085 01:19:57,880 --> 01:19:59,640 AND ARE PEOPLE SEEING MY SLIDES? 2086 01:19:59,640 --> 01:20:01,800 >>YES. 2087 01:20:01,800 --> 01:20:02,400 >>GREAT. 2088 01:20:02,400 --> 01:20:04,200 SO BEFORE I GET STARTED, I JUST 2089 01:20:04,200 --> 01:20:08,120 WANT TO ACKNOWLEDGE ALL THE 2090 01:20:08,120 --> 01:20:09,440 PEOPLE THAT REALLY MAKE 2091 01:20:09,440 --> 01:20:10,800 EVERYTHING I'M ABOUT TO PRESENT 2092 01:20:10,800 --> 01:20:12,200 TODAY POSSIBLE. 2093 01:20:12,200 --> 01:20:14,280 THE 42 PEOPLE HERE ON THE SCREEN 2094 01:20:14,280 --> 01:20:16,320 ARE REALLY THE WORKHORSES AND 2095 01:20:16,320 --> 01:20:18,840 THE PEOPLE THAT ACTUALLY DO ALL 2096 01:20:18,840 --> 01:20:20,480 THE WORK THAT I HAVE THE 2097 01:20:20,480 --> 01:20:21,240 PRIVILEGE OF PRESENTING TO YOU 2098 01:20:21,240 --> 01:20:22,200 TODAY. 2099 01:20:22,200 --> 01:20:24,320 THEY WORK TIRELESSLY, OF COURSE 2100 01:20:24,320 --> 01:20:25,280 TOGETHER WITH THE INVESTIGATORS 2101 01:20:25,280 --> 01:20:27,920 THAT WE FUND TO REALLY DRIVE THE 2102 01:20:27,920 --> 01:20:29,560 SCIENCE OF HIV THERAPEUTICS 2103 01:20:29,560 --> 01:20:33,040 FORWARD ON A DAILY BASIS. 2104 01:20:33,040 --> 01:20:36,360 SO AS CARL NOTED, WE WERE REALLY 2105 01:20:36,360 --> 01:20:39,000 FORTUNATE TO HIRE DR. VERNON 2106 01:20:39,000 --> 01:20:41,760 FROM THE CDC AS OUR NEW TB 2107 01:20:41,760 --> 01:20:43,520 CLINICAL RESEARCH BRANCH CHIEF, 2108 01:20:43,520 --> 01:20:54,040 AND ALSO WE RECENTLY APPOINTED 2109 01:20:54,720 --> 01:20:58,360 DR. LI ZHANG AS ASSOCIATE 2110 01:20:58,360 --> 01:20:58,880 DIRECTOR. 2111 01:20:58,880 --> 01:21:03,160 DAVID MAILHOT IS CLINICAL 2112 01:21:03,160 --> 01:21:04,280 PROJECT MANAGER TO HELP US WITH 2113 01:21:04,280 --> 01:21:09,520 SOME OF OUR PANDEMIC RESPONSE 2114 01:21:09,520 --> 01:21:13,560 TRIALS, MEDICAL OFFICER, ROGER 2115 01:21:13,560 --> 01:21:15,240 PTAK AS SENIOR RESEARCH ADVISOR. 2116 01:21:15,240 --> 01:21:18,040 SO THE OVERALL GOAL OF THE 2117 01:21:18,040 --> 01:21:19,280 THERAPEUTIC RESEARCH PROGRAM IS 2118 01:21:19,280 --> 01:21:21,520 TO IMPROVE THE HEALTH OF PEOPLE 2119 01:21:21,520 --> 01:21:24,600 LIVING WITH HIV, AND WE DO THAT 2120 01:21:24,600 --> 01:21:26,360 BY DEVELOPING NEW AND IMPROVED 2121 01:21:26,360 --> 01:21:28,000 THERAPEUTICS AND DIAGNOSTICS, 2122 01:21:28,000 --> 01:21:31,360 AND ADVANCING STRATEGIES TO 2123 01:21:31,360 --> 01:21:32,680 ACHIEVE DURABLE VIRAL 2124 01:21:32,680 --> 01:21:35,120 SUPPRESSION AND ART-FREE 2125 01:21:35,120 --> 01:21:36,200 REMISSION, ALSO KNOWN AS HIV 2126 01:21:36,200 --> 01:21:36,520 CURE. 2127 01:21:36,520 --> 01:21:38,160 BUT BEYOND THAT, WE ALL KNOW 2128 01:21:38,160 --> 01:21:40,160 THAT PEOPLE WITH HIV ALSO SUFFER 2129 01:21:40,160 --> 01:21:42,840 FROM A NUMBER OF COINFECTIONS 2130 01:21:42,840 --> 01:21:43,840 AND COMORBIDITIES THAT ARE 2131 01:21:43,840 --> 01:21:45,600 REALLY AFFECTING THEIR LIVES 2132 01:21:45,600 --> 01:21:48,240 EVERY DAY, AND SO WE DO HAVE A 2133 01:21:48,240 --> 01:21:52,040 SIGNIFICANT FOCUS ON THOSE VERY 2134 01:21:52,040 --> 01:21:53,320 INFECTIONS AND COMORBIDITIES. 2135 01:21:53,320 --> 01:21:55,840 IN TOTAL IN 2022, WE FUNDED A 2136 01:21:55,840 --> 01:21:59,120 TOTAL OF 147 GRANTS AND SEVEN 2137 01:21:59,120 --> 01:22:01,440 CONTRACTS, AND 92 TRIALS, WHICH 2138 01:22:01,440 --> 01:22:06,400 RESULTED IN 125 PUBLICATIONS. 2139 01:22:06,400 --> 01:22:08,560 SO TRP ACTIVITY AS NOTED ARE 2140 01:22:08,560 --> 01:22:09,960 WEIGHTED TOWARDS CLINICAL TRIALS 2141 01:22:09,960 --> 01:22:13,800 AS OPPOSED TO THE BASIC SCIENCE 2142 01:22:13,800 --> 01:22:15,480 PROGRAM WHO AS YOU HEARD FROM 2143 01:22:15,480 --> 01:22:16,240 DIANA TODAY. 2144 01:22:16,240 --> 01:22:18,000 WE HAVE MORE THAN 90 ACTIVE 2145 01:22:18,000 --> 01:22:19,480 CLINICAL TRIALS THAT ARE ALSO -- 2146 01:22:19,480 --> 01:22:21,120 SOME OF THEM ARE IN DEVELOPMENT, 2147 01:22:21,120 --> 01:22:23,000 AND AS YOU CAN SEE, THEY SPAN 2148 01:22:23,000 --> 01:22:25,600 THE RANGE OF HIV CURE TO 2149 01:22:25,600 --> 01:22:29,000 TREATMENT, BUT ALSO TB, 2150 01:22:29,000 --> 01:22:30,760 HEPATITIS, DIAGNOSTICS, AND AS 2151 01:22:30,760 --> 01:22:33,360 I'LL NOTE LATER TODAY AS CARL 2152 01:22:33,360 --> 01:22:35,960 MENTIONED, WE HAVE BEEN ASKED TO 2153 01:22:35,960 --> 01:22:37,640 TAKE THE LEAD ON DEVELOPING 2154 01:22:37,640 --> 01:22:40,040 OUTPATIENT TREATMENTS FOR 2155 01:22:40,040 --> 01:22:42,320 PANDEMICS, SO WE STARTED WITH 2156 01:22:42,320 --> 01:22:44,600 COVID-19, AND THEN ALSO 2157 01:22:44,600 --> 01:22:48,000 MONKEYPOX. 2158 01:22:48,000 --> 01:22:49,560 SO BEYOND THE CLINICAL TRIALS, 2159 01:22:49,560 --> 01:22:50,800 HOWEVER, IN ORDER TO HELP US 2160 01:22:50,800 --> 01:22:52,960 KEEP THE CLINICAL TRIAL PIPELINE 2161 01:22:52,960 --> 01:22:54,800 AT THE CUTTING EDGE, WE MAINTAIN 2162 01:22:54,800 --> 01:22:58,720 A NUMBER OF PRE-CLINICAL 2163 01:22:58,720 --> 01:23:03,600 CONTRACTS AND GRANTS TO 2164 01:23:03,600 --> 01:23:04,360 FACILITATE THIS RESEARCH. 2165 01:23:04,360 --> 01:23:05,920 ONE OF THE EXAMPLES OF THIS IS A 2166 01:23:05,920 --> 01:23:08,160 VERY LARGE CONTRACT THAT WE FUND 2167 01:23:08,160 --> 01:23:14,640 TOGETHER WITH BSP THAT PROVIDES 2168 01:23:14,640 --> 01:23:16,840 GAP FILLING SERVICES FOR HIV AND 2169 01:23:16,840 --> 01:23:18,160 HIV ASSOCIATED COINFECTIONS. 2170 01:23:18,160 --> 01:23:21,320 AND AS YOU CAN SEE, THIS SINGLE 2171 01:23:21,320 --> 01:23:25,440 CONTRACT IS MADE UP OF MULTIPLE 2172 01:23:25,440 --> 01:23:26,640 SUBCOMPONENTS THAT COULD 2173 01:23:26,640 --> 01:23:28,000 FACILITATE ANYTHING FROM IN 2174 01:23:28,000 --> 01:23:29,280 VITRO TESTING AND SCREENING TO 2175 01:23:29,280 --> 01:23:30,680 CHEMICAL SYNTHESIS TO ANIMAL 2176 01:23:30,680 --> 01:23:34,240 MODEL TESTING TO PRE-CLINICAL 2177 01:23:34,240 --> 01:23:37,280 PHARMACOLOGY AND TOXICOLOGY TO 2178 01:23:37,280 --> 01:23:38,280 MANUFACTURING. 2179 01:23:38,280 --> 01:23:44,520 AND WE RECENTLY RELEASED AN FOA, 2180 01:23:44,520 --> 01:23:45,560 PDR22-185, TO MAKE IT EVEN MORE 2181 01:23:45,560 --> 01:23:47,200 CLEAR TO THE INVESTIGATIVE FIELD 2182 01:23:47,200 --> 01:23:48,520 HOW TO GET ACCESS TO THIS 2183 01:23:48,520 --> 01:23:52,000 IMPORTANT RESOURCE. 2184 01:23:52,000 --> 01:23:56,040 ANOTHER GOOD EXAMPLE OF A 2185 01:23:56,040 --> 01:23:57,480 INFRASTRUCTURAL GRANT IS AN R24 2186 01:23:57,480 --> 01:23:59,000 THAT WE FUND CALLED LEAP. 2187 01:23:59,000 --> 01:24:00,440 AND MANY OF YOU PROBABLY ALREADY 2188 01:24:00,440 --> 01:24:03,400 KNOW ABOUT THIS PROGRAM. 2189 01:24:03,400 --> 01:24:07,440 IT ESSENTIALLY A PROGRAM -- ITS 2190 01:24:07,440 --> 01:24:09,480 ESSENTIALLY A PROGRAM WE HELP 2191 01:24:09,480 --> 01:24:12,120 MAINTAIN TO HELP FACILITATE THE 2192 01:24:12,120 --> 01:24:13,960 SCIENTIFIC COMMUNITY TO DEVELOP 2193 01:24:13,960 --> 01:24:14,720 LONG-ACTING FORMULATIONS. 2194 01:24:14,720 --> 01:24:18,800 AND THEY RECENTLY RELEASED A CID 2195 01:24:18,800 --> 01:24:20,320 SUPPLEMENT WITH SEVERAL REALLY 2196 01:24:20,320 --> 01:24:23,160 FANTASTIC ARTICLES DELINEATING 2197 01:24:23,160 --> 01:24:25,160 BOTH ACHIEVEMENTS IN LONG-ACTING 2198 01:24:25,160 --> 01:24:26,680 FORMULATION TECHNOLOGIES AND 2199 01:24:26,680 --> 01:24:29,200 ALSO FUTURE NEEDS. 2200 01:24:29,200 --> 01:24:31,600 AND SO FROM HERE ON OUT, I WILL 2201 01:24:31,600 --> 01:24:34,360 TAKE MY TIME TO JUST DESCRIBE 2202 01:24:34,360 --> 01:24:37,520 SOME RECENT ADVANCES AND ONGOING 2203 01:24:37,520 --> 01:24:38,720 ACTIVITIES AND ANTICIPATED 2204 01:24:38,720 --> 01:24:40,560 PRIORITIES FOR EACH OF THE FOUR 2205 01:24:40,560 --> 01:24:45,840 PRIMARY AREAS OF FOCUS FOR TRP. 2206 01:24:45,840 --> 01:24:51,000 FIRST AND FOREMOST, HIV BUT ALSO 2207 01:24:51,000 --> 01:24:51,960 TUBERCULOSIS, HEPATITIS AND 2208 01:24:51,960 --> 01:24:52,400 PANDEMIC RESPONSE. 2209 01:24:52,400 --> 01:24:54,520 SO TO START WITH HIV, OUR LONG 2210 01:24:54,520 --> 01:24:56,880 TERM GOALS INCLUDE DEVELOPING 2211 01:24:56,880 --> 01:25:06,760 NEW AND IMPROVED TREATMENTS AND 2212 01:25:06,760 --> 01:25:07,840 STRATEGIES, POINT OF CARE HOME 2213 01:25:07,840 --> 01:25:09,600 BASED DIAGNOSTICS, ART-FREE 2214 01:25:09,600 --> 01:25:11,560 REMISSION AND CURE AND ADDRESS 2215 01:25:11,560 --> 01:25:15,280 KIKO MORBIDITIES THROUGH 2216 01:25:15,280 --> 01:25:17,280 COLLABORATIONS. 2217 01:25:17,280 --> 01:25:19,080 RECENTLY THEY WERE ABLE TO 2218 01:25:19,080 --> 01:25:24,560 DEVELOP NANOFORMULATIONS WHICH 2219 01:25:24,560 --> 01:25:26,560 SUPPORTS Q6-MONTH INJECTIONS IN 2220 01:25:26,560 --> 01:25:27,200 NON-HUMAN PRIMATES. 2221 01:25:27,200 --> 01:25:28,960 AS YOU CAN SEE, THESE ADVANCES 2222 01:25:28,960 --> 01:25:31,160 AS YOU HEARD FROM DIANA, THESE 2223 01:25:31,160 --> 01:25:33,400 ADVANCES ARE IN LINE WITH OTHER 2224 01:25:33,400 --> 01:25:34,840 WORK THAT'S GOING ON. 2225 01:25:34,840 --> 01:25:36,800 IT'S BEEN A REALLY FANTASTIC 2226 01:25:36,800 --> 01:25:38,600 COUPLE OF YEARS AS DR. GANDHI 2227 01:25:38,600 --> 01:25:40,080 NOTED FOR LONG-ACTING 2228 01:25:40,080 --> 01:25:41,240 FORMULATIONS, AND WE BELIEVE 2229 01:25:41,240 --> 01:25:43,440 THAT DEVELOPING MORE LONG-ACTING 2230 01:25:43,440 --> 01:25:46,240 FORMULATIONS, THAT COULD BE 2231 01:25:46,240 --> 01:25:47,120 PAIRED TOGETHER. 2232 01:25:47,120 --> 01:25:49,400 THAT COULD ALSO BE USED IN THE 2233 01:25:49,400 --> 01:25:51,840 MOST NEEDY POPULATIONS AS PEOPLE 2234 01:25:51,840 --> 01:25:54,760 HAVE NOTED IN COUNCIL IS REALLY 2235 01:25:54,760 --> 01:25:57,400 IMPORTANT, AND WE'RE EXCITED TO 2236 01:25:57,400 --> 01:25:58,720 SEE THESE NEW TWO DRUGS BEING 2237 01:25:58,720 --> 01:26:00,440 DEVELOPED INTO LONG-ACTING 2238 01:26:00,440 --> 01:26:02,880 FORMULATIONS. 2239 01:26:02,880 --> 01:26:03,800 BUT OF COURSE IT'S NOT JUST 2240 01:26:03,800 --> 01:26:04,960 ABOUT THE DRUGS BUT WE'RE 2241 01:26:04,960 --> 01:26:08,320 FOCUSED ON HIV CURE, AND OTHER 2242 01:26:08,320 --> 01:26:10,400 NOVEL TECHNOLOGIES THAT MAY BE 2243 01:26:10,400 --> 01:26:13,120 PAIRED WITH DRUGS TO ENHANCE HIV 2244 01:26:13,120 --> 01:26:14,560 TREATMENT, THE BROADLY 2245 01:26:14,560 --> 01:26:17,960 NEUTRALIZING ANTIBODIES FOR HIV 2246 01:26:17,960 --> 01:26:19,040 REPRESENT THAT FIELD AND CLASS 2247 01:26:19,040 --> 01:26:22,800 OF TREATMENTS, AND DR. GABLER 2248 01:26:22,800 --> 01:26:24,640 AND COLLEAGUES RECENTLY 2249 01:26:24,640 --> 01:26:25,800 DESCRIBED THE TRIAL WHERE THEY 2250 01:26:25,800 --> 01:26:29,440 WERE ABLE TO COMBINE TWO BROADLY 2251 01:26:29,440 --> 01:26:34,480 NEUTRALIZING ANTIBODIES, 101074 2252 01:26:34,480 --> 01:26:40,680 AND - 3BNC117, AND EVEN WITH THT 2253 01:26:40,680 --> 01:26:42,440 SUPPRESSION THEY WERE ABLE TO 2254 01:26:42,440 --> 01:26:46,400 FIND THE TWO BNABs WERE ABLE 2255 01:26:46,400 --> 01:26:47,600 TO EFFECT VIRAL SUPPRESSION OVER 2256 01:26:47,600 --> 01:26:49,040 A LONG PERIOD OF TIME. 2257 01:26:49,040 --> 01:26:51,000 SO SOME ONGOING WORK AND FUTURE 2258 01:26:51,000 --> 01:26:53,160 PRIORITIES FOR HIV. 2259 01:26:53,160 --> 01:26:55,360 OF COURSE WE WANT TO GO BEYOND 2260 01:26:55,360 --> 01:26:57,240 THE BROADLY NEUTRALIZING 2261 01:26:57,240 --> 01:26:58,880 ANTIBODIES TO REALLY BE ABLE TO 2262 01:26:58,880 --> 01:27:02,280 EFFECT THERAPEUTIC VACCINES THAT 2263 01:27:02,280 --> 01:27:04,440 MIGHT HAVE A THERAPEUTIC 2264 01:27:04,440 --> 01:27:05,440 BENEFIT, EVEN CURE, FOR PEOPLE 2265 01:27:05,440 --> 01:27:05,960 WITH HIV. 2266 01:27:05,960 --> 01:27:08,080 SO WE'RE HARD AT WORK, WORKING 2267 01:27:08,080 --> 01:27:09,760 WITH OUR INVESTIGATORS TO 2268 01:27:09,760 --> 01:27:13,120 DEVELOP BNAB INDUCING VACCINES, 2269 01:27:13,120 --> 01:27:15,200 AND ALSO T-CELL INDUCING 2270 01:27:15,200 --> 01:27:17,720 VACCINES, AND THEN NOVEL 2271 01:27:17,720 --> 01:27:21,840 COMBINATIONS OF THESE DIFFERENT 2272 01:27:21,840 --> 01:27:25,400 VARIETIES OF INTERVENTIONS. 2273 01:27:25,400 --> 01:27:27,760 OF COURSE THROUGH THE PROPER 2274 01:27:27,760 --> 01:27:29,440 RESEARCH ON DRUG RESISTANCE, 2275 01:27:29,440 --> 01:27:31,600 BNAB RESISTANCE, AND OTHER ANS 2276 01:27:31,600 --> 01:27:38,160 LEAR RESEARCANCILLARY RESEARCH T 2277 01:27:38,160 --> 01:27:40,160 ONCE WE HAVE THESE INTERVENTIONS 2278 01:27:40,160 --> 01:27:41,800 DEVELOP, WE WILL BE RAPIDLY ABLE 2279 01:27:41,800 --> 01:27:43,560 TO DEVELOP THEM TO THE BEDSIDE. 2280 01:27:43,560 --> 01:27:47,160 BEYOND JUST THESE MORE -- THE 2281 01:27:47,160 --> 01:27:50,320 NOVEL TYPE OF TECHNOLOGIES, WE 2282 01:27:50,320 --> 01:27:52,520 ARE ALSO COMMITTED TO DEVELOPING 2283 01:27:52,520 --> 01:27:55,280 LONG-ACTING REGIMENS, BNABs AS 2284 01:27:55,280 --> 01:27:56,840 TREATMENTS, NOVEL DIAGNOSTICS, 2285 01:27:56,840 --> 01:27:58,120 AND TREATMENT STRATEGIES THAT 2286 01:27:58,120 --> 01:28:00,560 ALL, I THINK, WILL PLAY A PART 2287 01:28:00,560 --> 01:28:03,080 TO EVENTUALLY BRING AN END TO 2288 01:28:03,080 --> 01:28:04,120 THE HIV EPIDEMIC. 2289 01:28:04,120 --> 01:28:06,120 AS YOU CAN SEE, OUR PAROLE 2290 01:28:06,120 --> 01:28:08,840 CONSISTS OF MULTIPLE CLINICAL 2291 01:28:08,840 --> 01:28:09,320 TRIALS. 2292 01:28:09,320 --> 01:28:10,280 THESE ARE JUST SOME OF THE 2293 01:28:10,280 --> 01:28:11,800 EXAMPLES WE HAVE ONGOING THROUGH 2294 01:28:11,800 --> 01:28:13,120 THE ACTG. 2295 01:28:13,120 --> 01:28:14,880 WE ALSO HAVE NON-NETWORK 2296 01:28:14,880 --> 01:28:16,960 CLINICAL TRIALS THAT WE FUND 2297 01:28:16,960 --> 01:28:20,440 THAT ALSO ARE WORKING TO JUST 2298 01:28:20,440 --> 01:28:23,200 ESTABLISH NOVEL STRATEGIES, AND 2299 01:28:23,200 --> 01:28:25,360 ALSO OF COURSE THE PRE-CLINICAL 2300 01:28:25,360 --> 01:28:26,560 RESEARCH PORTFOLIO AGAIN IS 2301 01:28:26,560 --> 01:28:30,920 CRITICAL TO KEEP THAT CLINICAL 2302 01:28:30,920 --> 01:28:32,120 PORTFOLIO AT THE CUTTING EDGE. 2303 01:28:32,120 --> 01:28:35,240 SO MOVING ON TO TUBERCULOSIS. 2304 01:28:35,240 --> 01:28:37,480 AS MOST PEOPLE IN THE COUNCIL 2305 01:28:37,480 --> 01:28:40,920 KNOW, TB IS THE LEADING CAUSE OF 2306 01:28:40,920 --> 01:28:42,720 THAT, AND MORBIDITY AMONG PEOPLE 2307 01:28:42,720 --> 01:28:46,600 WITH HIV. 2308 01:28:46,600 --> 01:28:49,200 IN 2021, THERE WERE OVER 187,000 2309 01:28:49,200 --> 01:28:52,080 DEATHS FROM TB JUST AMONG PEOPLE 2310 01:28:52,080 --> 01:28:57,320 WITH HIV, NOT INCLUDING THOSE 2311 01:28:57,320 --> 01:28:58,600 THAT -- GIVEN THE DEATHS AMONG 2312 01:28:58,600 --> 01:29:00,040 THOSE THAT DON'T HAVE HIV. 2313 01:29:00,040 --> 01:29:02,120 ACTUALLY THE COVID PANDEMIC MADE 2314 01:29:02,120 --> 01:29:03,240 A NEGATIVE DIFFERENCE OR IMPACT 2315 01:29:03,240 --> 01:29:05,440 ON TB OVERALL, INCLUDING IN 2316 01:29:05,440 --> 01:29:07,080 PEOPLE LIVING WITH HIV, AND SO 2317 01:29:07,080 --> 01:29:09,520 WE ARE REALLY WORKING HARD TO 2318 01:29:09,520 --> 01:29:12,160 ADVANCE TECHNOLOGIES AND 2319 01:29:12,160 --> 01:29:13,480 IMPROVEMENTS THAT WILL GET US 2320 01:29:13,480 --> 01:29:16,400 BACK ON TRACK FOR TB, FIRST AND 2321 01:29:16,400 --> 01:29:17,600 FOREMOST FOR PEOPLE LIVING WITH 2322 01:29:17,600 --> 01:29:18,880 HIV. 2323 01:29:18,880 --> 01:29:23,160 SO OUR LONG TERM GOALS WITH TB 2324 01:29:23,160 --> 01:29:24,360 INCLUDE NEW PREVENTION 2325 01:29:24,360 --> 01:29:25,760 STRATEGIES, DEVELOPING NEW 2326 01:29:25,760 --> 01:29:27,600 DIAGNOSTICS AND TREATMENTS FOR 2327 01:29:27,600 --> 01:29:29,920 TB AND HIV AND ADVANCING 2328 01:29:29,920 --> 01:29:30,760 CLINICAL OBSERVATIONAL RESEARCH 2329 01:29:30,760 --> 01:29:33,080 IN REGIONS MOST AFFECTED BY 2330 01:29:33,080 --> 01:29:33,800 TB/HIV. 2331 01:29:33,800 --> 01:29:39,080 SO SOME SELECT ADVANCES. 2332 01:29:39,080 --> 01:29:40,080 DR. DENARDO AND COLLEAGUES 2333 01:29:40,080 --> 01:29:42,280 RECENTLY DESCRIBED THROUGH A 2334 01:29:42,280 --> 01:29:45,560 COHORT OF 435 NTB PATIENT, THAT 2335 01:29:45,560 --> 01:29:47,760 THEY WERE ABLE TO IDENTIFY TWO 2336 01:29:47,760 --> 01:29:49,520 DISTINCT ENDO TYPES, ONE FOR 2337 01:29:49,520 --> 01:29:50,600 TREATMENT FAILURE AND SLOWER 2338 01:29:50,600 --> 01:29:54,320 TIME TO CULTURE CONVERSION, AND 2339 01:29:54,320 --> 01:29:56,840 ANOTHER FOR IMPROVED CLINICAL 2340 01:29:56,840 --> 01:30:01,200 OUTCOMES. 2341 01:30:01,200 --> 01:30:03,800 THE IMPORTANT THING IN THESE 2342 01:30:03,800 --> 01:30:05,600 FINDINGS IS IT COULD HELP US 2343 01:30:05,600 --> 01:30:06,840 IDENTIFY THOSE WHO MAY BENEFIT 2344 01:30:06,840 --> 01:30:08,360 FROM SHORTER COURSE THERAPY AND 2345 01:30:08,360 --> 01:30:09,640 ENABLE PATIENT-SPECIFIC 2346 01:30:09,640 --> 01:30:11,040 APPROACHES TO IMPROVED TREATMENT 2347 01:30:11,040 --> 01:30:11,720 OUTCOMES. 2348 01:30:11,720 --> 01:30:12,840 BUT OF COURSE IT'S NOT JUST 2349 01:30:12,840 --> 01:30:14,680 ABOUT THESE NOVEL ASSAYS THAT 2350 01:30:14,680 --> 01:30:15,400 ARE IMPORTANT. 2351 01:30:15,400 --> 01:30:16,840 WE BELIEVE THERE'S A LOT OF 2352 01:30:16,840 --> 01:30:18,200 KNOWLEDGE THAT CAN BE GAINED 2353 01:30:18,200 --> 01:30:19,720 JUST FROM CLINICALLY 2354 01:30:19,720 --> 01:30:21,840 IDENTIFIABLE AND OBSERVABLE 2355 01:30:21,840 --> 01:30:24,120 EFFECTS, AND OUR COLLEAGUES AT 2356 01:30:24,120 --> 01:30:25,880 THE REPORT BRAZIL CONSORTIUM 2357 01:30:25,880 --> 01:30:27,800 ALSO WERE ABLE TO IDENTIFY THAT 2358 01:30:27,800 --> 01:30:29,480 THERE WERE DISTINCT PREDICTORS 2359 01:30:29,480 --> 01:30:31,360 FOR EACH TYPE OF UNSUCCESSFUL 2360 01:30:31,360 --> 01:30:33,760 OUTCOME WHEN THEY APPLIED A 2361 01:30:33,760 --> 01:30:35,720 COMPOSITE OF DIFFERENT CLINICAL 2362 01:30:35,720 --> 01:30:36,920 OUTCOME MEASURES IN THEIR 2363 01:30:36,920 --> 01:30:37,880 COHORT. 2364 01:30:37,880 --> 01:30:39,320 WHICH IS REALLY IMPORTANT. 2365 01:30:39,320 --> 01:30:41,240 I THINK THE FUTURE HOLDS THAT WE 2366 01:30:41,240 --> 01:30:43,720 WILL BE ABLE TO EVENTUALLY 2367 01:30:43,720 --> 01:30:48,280 COMBINE BOTH CLINICAL AND ALSO 2368 01:30:48,280 --> 01:30:49,640 BLOOD-BASED BIOMARKERS TO REALLY 2369 01:30:49,640 --> 01:30:52,560 HONE OUR TREATMENT OF TB 2370 01:30:52,560 --> 01:30:53,680 INFECTED PATIENTS INCLUDING 2371 01:30:53,680 --> 01:30:56,920 PEOPLE WITH HIV IN THE FUTURE. 2372 01:30:56,920 --> 01:30:59,480 SO ONGOING WORK AT FUTURE 2373 01:30:59,480 --> 01:31:00,760 PRIORITIES FOR TB, I THINK 2374 01:31:00,760 --> 01:31:02,080 ANYONE THAT FOLLOWS THE 2375 01:31:02,080 --> 01:31:05,240 LITERATURE FOR TB KNOWS THAT 2376 01:31:05,240 --> 01:31:07,920 IT'S BEEN -- DESPITE THE 2377 01:31:07,920 --> 01:31:09,200 COVID-19 PANDEMIC, IT'S BEEN A 2378 01:31:09,200 --> 01:31:13,360 FEW GOOD YEARS FOR TB. 2379 01:31:13,360 --> 01:31:17,320 NOT ONLY IS THE TB PIPELINE THE 2380 01:31:17,320 --> 01:31:19,840 FULLEST IT BEEN SINCE THE 2381 01:31:19,840 --> 01:31:21,160 BEGINNING OF TB RESEARCH, BUT 2382 01:31:21,160 --> 01:31:22,600 ALSO THERE HAVE BEEN A NUMBER OF 2383 01:31:22,600 --> 01:31:24,320 REALLY JUST VERY IMPORTANT 2384 01:31:24,320 --> 01:31:27,320 ADVANCEMENTS IN TB CLINICAL 2385 01:31:27,320 --> 01:31:27,520 TRIALS. 2386 01:31:27,520 --> 01:31:30,320 WE ARE NOW ABLE TO TREAT LTBI IN 2387 01:31:30,320 --> 01:31:32,240 LESS THAN ONE MONTH. 2388 01:31:32,240 --> 01:31:33,320 WE ALSO CONTRIBUTE TO A STUDY 2389 01:31:33,320 --> 01:31:36,800 THAT SHOWED WE CAN TREAT REGULAR 2390 01:31:36,800 --> 01:31:38,760 TB DISEASE WITH FOUR MONTHS 2391 01:31:38,760 --> 01:31:40,200 THERAPY, BUT TO BUILD ON THESE 2392 01:31:40,200 --> 01:31:42,760 SUCCESSES, WE ALSO HAVE 16 2393 01:31:42,760 --> 01:31:46,160 TRIALS ONGOING TO DEVELOP AND 2394 01:31:46,160 --> 01:31:47,680 EVALUATE NOVEL REGIMENS. 2395 01:31:47,680 --> 01:31:49,640 WE ALSO HAVE A SIGNIFICANT 2396 01:31:49,640 --> 01:31:51,000 PORTFOLIO, SURROGATE BIOMARKER 2397 01:31:51,000 --> 01:31:52,920 RESEARCH TO ENABLE MORE 2398 01:31:52,920 --> 01:31:54,280 EFFICIENT TRIAL DESIGNS OR 2399 01:31:54,280 --> 01:31:56,080 FASTER BREAKTHROUGHS, IMPROVED 2400 01:31:56,080 --> 01:31:57,960 CLINICAL CARE, AND MOST 2401 01:31:57,960 --> 01:32:00,160 IMPORTANTLY, WE ARE WORKING WITH 2402 01:32:00,160 --> 01:32:02,600 OTHER FUNDING PARTNERS BOTH AT 2403 01:32:02,600 --> 01:32:03,720 THE GATES FOUNDATION AND IN 2404 01:32:03,720 --> 01:32:05,440 EUROPE AND AROUND THE WORLD TO 2405 01:32:05,440 --> 01:32:06,800 DEVELOP INFRASTRUCTURES AND 2406 01:32:06,800 --> 01:32:09,280 STRUCTURES TO FACILITATE 2407 01:32:09,280 --> 01:32:11,640 COMMUNICATION, COORDINATION AND 2408 01:32:11,640 --> 01:32:13,440 COLLABORATION AMONG THE GLOBAL 2409 01:32:13,440 --> 01:32:15,400 RESEARCH ORGANIZATIONS TO 2410 01:32:15,400 --> 01:32:17,360 REALIZE SYNERGIES ACROSS THE 2411 01:32:17,360 --> 01:32:20,000 RESEARCH FIELD. 2412 01:32:20,000 --> 01:32:21,680 JUST TWO EXAMPLES OF IMPORTANT 2413 01:32:21,680 --> 01:32:23,760 TRIALS THAT WE HAVE ONGOING FOR 2414 01:32:23,760 --> 01:32:26,360 TB ARE THE SPECTRA STUDY, WHICH 2415 01:32:26,360 --> 01:32:29,160 IS A PHASE 2B DURATION 2416 01:32:29,160 --> 01:32:31,240 RANDOMIZED STUDY LOOKING AT A 2417 01:32:31,240 --> 01:32:36,280 COMBINATION OF INH -- TO SEE HOW 2418 01:32:36,280 --> 01:32:37,360 LOW OR HOW SHORT WE CAN REALLY 2419 01:32:37,360 --> 01:32:40,120 GO WITH THIS REGIMEN FOR PEOPLE 2420 01:32:40,120 --> 01:32:43,600 WITH BOTH LOW AND HIGH RISK TB. 2421 01:32:43,600 --> 01:32:50,960 ALSO, ACTG5405409 ALSO KNOWN ASE 2422 01:32:50,960 --> 01:32:53,600 RAD-TB STUDY, NEW NOVEL IMI 2423 01:32:53,600 --> 01:32:55,680 NATIONS OF THE TB DRUGS I JUST 2424 01:32:55,680 --> 01:32:57,320 SHOWED YOU TO SHOW WHICH 2425 01:32:57,320 --> 01:32:58,000 COMBINATIONS WOULD WORK THE BEST 2426 01:32:58,000 --> 01:32:59,000 FOR THE TREAT. 2427 01:32:59,000 --> 01:33:00,720 OF ACTIVE TB. 2428 01:33:00,720 --> 01:33:03,920 AND THIS STUDY IS COUPLED WITH A 2429 01:33:03,920 --> 01:33:05,760 WHOLE 'NOTHER PRE-CLINICAL 2430 01:33:05,760 --> 01:33:07,320 EFFORT, MODELING EFFORT TO 2431 01:33:07,320 --> 01:33:10,760 REALLY GET TO FASTER ADVANCEMENT 2432 01:33:10,760 --> 01:33:15,880 OF NEW NOVEL REGIMENS FOR TB. 2433 01:33:15,880 --> 01:33:17,720 MOVING ON TO HEPATITIS. 2434 01:33:17,720 --> 01:33:20,920 BEYOND TB, I THINK ALSO MANY OF 2435 01:33:20,920 --> 01:33:23,240 US RECOGNIZE THAT HEPATITIS IS 2436 01:33:23,240 --> 01:33:26,800 ALSO MAYBE THE NUMBER TWO MOST 2437 01:33:26,800 --> 01:33:28,600 IMPORTANT CAUSE OF DEATH AND 2438 01:33:28,600 --> 01:33:29,760 MORBIDITY AMONG PEOPLE WITH HIV, 2439 01:33:29,760 --> 01:33:31,640 SO WE ARE INCREASINGLY FOCUSED 2440 01:33:31,640 --> 01:33:33,480 ON THIS DISEASE TO MAKE SURE 2441 01:33:33,480 --> 01:33:38,200 THAT PEOPLE WITH HIV ARE NOT 2442 01:33:38,200 --> 01:33:40,920 UNDULY SUFFERING FROM HEPATITIS, 2443 01:33:40,920 --> 01:33:47,280 BOTH HEPATITIS B AND HEPATITIS C 2444 01:33:47,280 --> 01:33:48,720 AS DR. DIEFFENBACH IS A PRIORITY 2445 01:33:48,720 --> 01:33:52,360 FOR US, I IMPROVE TREATMENTS FOR 2446 01:33:52,360 --> 01:33:53,880 HEPATITIS C AND B ARE ANOTHER 2447 01:33:53,880 --> 01:33:55,280 PRIORITY, AND WE'RE ALSO LOOKING 2448 01:33:55,280 --> 01:33:57,680 FOR IMPROVED PREVENTIVE 2449 01:33:57,680 --> 01:33:59,880 HEPATITIS B VACCINES FOR PEOPLE 2450 01:33:59,880 --> 01:34:02,280 LIVING WITH HIV, AND ALSO OF 2451 01:34:02,280 --> 01:34:03,200 COURSE DIAGNOSTICS FOR BOTH 2452 01:34:03,200 --> 01:34:04,720 DISEASES. 2453 01:34:04,720 --> 01:34:08,320 SO SOME SELECT ADVANCES. 2454 01:34:08,320 --> 01:34:11,200 AS SOME PEOPLE MAY RECOGNIZE THE 2455 01:34:11,200 --> 01:34:14,240 ADVENT OF LONG-ACTING ANTI-HIV 2456 01:34:14,240 --> 01:34:18,320 TREATMENTS HAVE REALLY NOW PUT 2457 01:34:18,320 --> 01:34:19,720 THE HEPATITIS B FIELD ON EDGE 2458 01:34:19,720 --> 01:34:23,160 BECAUSE WHAT MAY HAPPEN IS THAT 2459 01:34:23,160 --> 01:34:29,400 THE CHANGE TO USING CATANUBA MAY 2460 01:34:29,400 --> 01:34:30,520 THEN LEAVE MANY, MANY PATIENTS 2461 01:34:30,520 --> 01:34:32,800 THAT HAVE HEPATITIS B BUT ARE 2462 01:34:32,800 --> 01:34:35,880 CURRENTLY UNDIAGNOSED WITHOUT AN 2463 01:34:35,880 --> 01:34:37,760 EFFECTIVE ANTIVIRAL AS PART OF 2464 01:34:37,760 --> 01:34:38,320 THEIR REGIMEN. 2465 01:34:38,320 --> 01:34:42,920 SO WE BELIEVE IT AN IMPORTANT 2466 01:34:42,920 --> 01:34:46,080 PRIORITY TO DEVELOP LONG-ACTING 2467 01:34:46,080 --> 01:34:48,640 ANTIREP TIGHTS B ANTIRETROVIRALS 2468 01:34:48,640 --> 01:34:50,600 THAT CAN BE COUPLED WITH ANTIHIV 2469 01:34:50,600 --> 01:34:51,800 TREATMENTS. 2470 01:34:51,800 --> 01:34:55,840 ONE SUCH EXAMPLE IS FROM DR. DAS 2471 01:34:55,840 --> 01:34:58,480 AND COLLEAGUES WHO SHOWED A 2472 01:34:58,480 --> 01:35:02,000 LONG-ACTING TENOFOVIR 2473 01:35:02,000 --> 01:35:04,000 NANOFORMULATION THAT AT LEAST IN 2474 01:35:04,000 --> 01:35:05,400 HUMANIZED MICE LOOKS LIKE IT 2475 01:35:05,400 --> 01:35:06,920 COULD ACHIEVE ACUTE THREE-MONTH 2476 01:35:06,920 --> 01:35:08,160 TREATMENT DURATION. 2477 01:35:08,160 --> 01:35:09,440 NOW THIS OBVIOUSLY NEEDS TO BE 2478 01:35:09,440 --> 01:35:12,480 FURTHER DEVELOPED AND TRANSLATED 2479 01:35:12,480 --> 01:35:15,880 FOR USE IN HUMANS, BUT THIS IS A 2480 01:35:15,880 --> 01:35:17,120 REALLY PROMISING START FOR A 2481 01:35:17,120 --> 01:35:20,640 VERY IMPORTANT FIELD. 2482 01:35:20,640 --> 01:35:23,920 MOVING ON TO THE CLINICAL AREA, 2483 01:35:23,920 --> 01:35:27,000 WE RECENTLY HAD A STUDY 5379, 2484 01:35:27,000 --> 01:35:28,880 IT'S AN ONGOING PHASE 3 STUDY 2485 01:35:28,880 --> 01:35:29,960 THAT WAS DESIGNED TO STUDY AND 2486 01:35:29,960 --> 01:35:33,480 COMPARE THE EFFICACY AND SAFETY 2487 01:35:33,480 --> 01:35:40,400 OF HEPLASAV-B AND ENGERIX-B IN 2488 01:35:40,400 --> 01:35:42,240 HBV VACCINE NON-RESPONDERS. 2489 01:35:42,240 --> 01:35:44,320 ANOTHER PRIMARY AIM OF THE STUDY 2490 01:35:44,320 --> 01:35:47,840 WAS LOOKING NE SMALLER PROP 2491 01:35:47,840 --> 01:35:54,200 LAITION JUST IN 2492 01:35:54,200 --> 01:35:54,800 HBV-VACCINE-NAIVE PATIENTS AND 2493 01:35:54,800 --> 01:35:58,760 THEY STUDIED A COCKTAIL OF THREE 2494 01:35:58,760 --> 01:36:01,440 VACCINATION REGIMEN OF 2495 01:36:01,440 --> 01:36:02,080 HEPLISAV-B. 2496 01:36:02,080 --> 01:36:10,600 WHAT THEY FOUND IS AMONG THOSE 2497 01:36:10,600 --> 01:36:13,800 WITH HBSAB RESULTS, 100% 2498 01:36:13,800 --> 01:36:15,440 ACHIEVED SPR AFTER THREE DOSES. 2499 01:36:15,440 --> 01:36:21,080 SPR IS THE NEUTRALIZING ANTIBODY 2500 01:36:21,080 --> 01:36:22,120 RESPONSE THAT IS EXPECTED TO 2501 01:36:22,120 --> 01:36:24,680 PROVIDE FULL PROTECTION AGAINST 2502 01:36:24,680 --> 01:36:25,880 HEPATITIS B. 2503 01:36:25,880 --> 01:36:28,040 AND EVEN AFTER TWO DOSES, THEY 2504 01:36:28,040 --> 01:36:34,160 FOUND THE MAJORITY HAD 2505 01:36:34,160 --> 01:36:34,720 PROTECTIVE RESPONSE. 2506 01:36:34,720 --> 01:36:36,520 THERE WERE NO SAFETY ISSUES OR 2507 01:36:36,520 --> 01:36:40,440 DEATHS TO DATE AND REMAIN IN 2508 01:36:40,440 --> 01:36:41,840 FOLLOW-UP TO ASSESS DUSHABILITY 2509 01:36:41,840 --> 01:36:42,840 OF RESPONSE AND SAFETY. 2510 01:36:42,840 --> 01:36:44,000 SO SOME ONGOING WORK IN 2511 01:36:44,000 --> 01:36:45,560 HEPATITIS B, WE HAVE A NUMBER OF 2512 01:36:45,560 --> 01:36:47,040 CLINICAL TRIALS THAT ARE 2513 01:36:47,040 --> 01:36:49,240 EVALUATING OTHER NOVEL REGIMENS 2514 01:36:49,240 --> 01:36:51,000 FOR HEPATITIS B CURE, BUT ALSO 2515 01:36:51,000 --> 01:36:53,840 WE BELIEVE THAT WE NEED TO DO 2516 01:36:53,840 --> 01:36:55,600 SOME ADDITIONAL WORK IN CLINICAL 2517 01:36:55,600 --> 01:36:57,680 OBSERVATIONAL RESEARCH AND IN 2518 01:36:57,680 --> 01:36:59,440 THE LABORATORY TO GET A BETTER 2519 01:36:59,440 --> 01:37:00,440 UNDERSTANDING OF THE 2520 01:37:00,440 --> 01:37:03,520 PATHOGENESIS AND THE PATHOLOGY 2521 01:37:03,520 --> 01:37:04,840 OF HEPATITIS B AND PEOPLE WITH 2522 01:37:04,840 --> 01:37:07,240 HIV, AND ALSO TO DEVELOP NOVEL 2523 01:37:07,240 --> 01:37:09,080 BIOMARKERS THAT WILL HELP US IN 2524 01:37:09,080 --> 01:37:12,080 OUR ENDEAVOR TO CURE HEPATITIS 2525 01:37:12,080 --> 01:37:12,840 B. 2526 01:37:12,840 --> 01:37:13,240 OKAY. 2527 01:37:13,240 --> 01:37:15,200 LAST BUT NOT LEAST IS THE 2528 01:37:15,200 --> 01:37:17,120 PANDEMIC RESPONSE, AND IF YOU 2529 01:37:17,120 --> 01:37:19,280 REMEMBER MY PRESENTATIONS FROM A 2530 01:37:19,280 --> 01:37:23,040 YEAR PAST, EARLY IN THE PANDEMIC 2531 01:37:23,040 --> 01:37:24,440 OUR GROUP ALONG WITH THE ACT 2532 01:37:24,440 --> 01:37:27,000 GWAS ASKED TO TAKE ON THE GOAL 2533 01:37:27,000 --> 01:37:29,880 OF DEVELOPING OUTPATIENT 2534 01:37:29,880 --> 01:37:34,680 TREATMENTS FOR COVID-19. 2535 01:37:34,680 --> 01:37:36,320 THEN THIS PAST YEAR MONKEYPOX 2536 01:37:36,320 --> 01:37:38,840 HIT AND WE WERE SIMILARLY ASKED 2537 01:37:38,840 --> 01:37:42,240 TO DEVELOP A CLINICAL TRIAL FOR 2538 01:37:42,240 --> 01:37:43,440 EVALUATION OF TPOXX. 2539 01:37:43,440 --> 01:37:46,520 SO TO DATE, AS A GROUP THAT WAS 2540 01:37:46,520 --> 01:37:48,480 NOT FOCUSED ON PANDEMIC RESPONSE 2541 01:37:48,480 --> 01:37:52,120 PRIOR TO COVID-19, NOW WE HAVE 2542 01:37:52,120 --> 01:37:53,320 EVALUATED TREATMENTS FOR TWO 2543 01:37:53,320 --> 01:37:56,240 NOVEL DISEASES, WE DESIGNED 2544 01:37:56,240 --> 01:37:58,160 SEVEN UNIQUE TRIALS, FIVE OF 2545 01:37:58,160 --> 01:37:59,360 THEM WERE IMPLEMENTED. 2546 01:37:59,360 --> 01:38:01,800 WE TESTED MORE THAN 10 AGENTS 2547 01:38:01,800 --> 01:38:03,080 ALONG WITH NINE INDUSTRY 2548 01:38:03,080 --> 01:38:04,880 PARTNERS. 2549 01:38:04,880 --> 01:38:08,480 THE ACTIV-2 STUDY WHICH YOU'VE 2550 01:38:08,480 --> 01:38:09,800 HEARD A LOT TODAY FROM 2551 01:38:09,800 --> 01:38:11,640 DR. DIEFFENBACH AND ALSO FROM 2552 01:38:11,640 --> 01:38:12,720 PREVIOUS YEARS' PRESENTATION THE 2553 01:38:12,720 --> 01:38:15,280 IS NOW FINISHING UP ALL THE 2554 01:38:15,280 --> 01:38:16,160 PARTICIPANTS ARE NOW IN 2555 01:38:16,160 --> 01:38:17,720 FOLLOW-UP PHASE AND WE ARE NOT 2556 01:38:17,720 --> 01:38:20,600 TAKING ANY NEW ENROLLMENTS INTO 2557 01:38:20,600 --> 01:38:21,720 THE STUDY. 2558 01:38:21,720 --> 01:38:23,280 INVESTIGATORS AT THE ACTG ARE 2559 01:38:23,280 --> 01:38:26,600 REALLY NOW FOCUSED ON GETTING 2560 01:38:26,600 --> 01:38:27,760 AND -- ANALYZING THE DATA AND 2561 01:38:27,760 --> 01:38:28,640 GETTING THE RESULTS OUT THERE. 2562 01:38:28,640 --> 01:38:30,760 US A CAN SEE, WE'VE HAD A NUMBER 2563 01:38:30,760 --> 01:38:34,280 OF PUBLICATIONS EVEN MORE 2564 01:38:34,280 --> 01:38:36,160 POSTERS AND ACTUALLY EVEN IN THE 2565 01:38:36,160 --> 01:38:37,760 TWO WEEKS SINCE I'VE PREPARED 2566 01:38:37,760 --> 01:38:39,880 THIS PRESENTATION, I THINK I'VE 2567 01:38:39,880 --> 01:38:41,120 HEARD THERE ARE AT LEAST TWO OR 2568 01:38:41,120 --> 01:38:42,400 THREE MORE PUBLICATIONS THAT ARE 2569 01:38:42,400 --> 01:38:44,040 GOING TO PRESS AS WE SPEAK. 2570 01:38:44,040 --> 01:38:50,560 SO WE EXPECT TO SEE A LOT MORE 2571 01:38:50,560 --> 01:38:52,800 OF THE RESULTS COMING FORTH FROM 2572 01:38:52,800 --> 01:38:54,160 THIS TRIAL IN THE VERY NEAR 2573 01:38:54,160 --> 01:38:55,680 FUTURE. 2574 01:38:55,680 --> 01:38:56,800 ANOTHER REALLY IMPORTANT STUDY 2575 01:38:56,800 --> 01:38:59,960 TO US IS THAT ACTIV 2D STUDY, 2576 01:38:59,960 --> 01:39:02,600 THIS IS A PHASE III STUDY TO 2577 01:39:02,600 --> 01:39:06,640 EVALUATE A NEW SARS-COV-2 3CL 2578 01:39:06,640 --> 01:39:08,840 PROTEASE INHIBITOR. 2579 01:39:08,840 --> 01:39:12,240 YOU MAY HAVE HEARD IN THE NEWS 2580 01:39:12,240 --> 01:39:15,560 THAT SHI KNOW GEE RECENTLY HAD 2581 01:39:15,560 --> 01:39:17,520 POSITIVE RESULTS FROM ANOTHER 2582 01:39:17,520 --> 01:39:19,600 PHASE 3 IN LOW RISK PARTICIPANTS 2583 01:39:19,600 --> 01:39:20,720 IN A CLINICAL TRIAL THAT WAS 2584 01:39:20,720 --> 01:39:23,320 PRIMARILY CONDUCTED IN ASIA. 2585 01:39:23,320 --> 01:39:25,600 SO THIS IS THE SECOND PHASE III 2586 01:39:25,600 --> 01:39:28,800 WE ARE CO CONDUCTING TOGETHER WH 2587 01:39:28,800 --> 01:39:29,240 THEM. 2588 01:39:29,240 --> 01:39:32,640 THE PRIMARY OUT COME, MEDIAN 2589 01:39:32,640 --> 01:39:35,000 TIME TO SUSTAINED SYMPTOM 2590 01:39:35,000 --> 01:39:35,840 RESOLUTION. 2591 01:39:35,840 --> 01:39:37,600 THIS IS A GLOBAL STUDY, WE HAVE 2592 01:39:37,600 --> 01:39:39,120 SITES CURRENTLY OPEN IN THE U.S. 2593 01:39:39,120 --> 01:39:40,600 AND JAPAN, WE HAVE ACTIVATED 2594 01:39:40,600 --> 01:39:42,480 SITES IN SOUTH AFRICA AND WE 2595 01:39:42,480 --> 01:39:43,560 EXPECT MANY MORE SITE 2596 01:39:43,560 --> 01:39:44,880 ACTIVATIONS IN THE ENSUING 2597 01:39:44,880 --> 01:39:45,880 MONTHS ALL OVER THE WORLD. 2598 01:39:45,880 --> 01:39:47,080 AND WE COULD REALLY USE YOUR 2599 01:39:47,080 --> 01:39:48,960 HELP TO GET THIS STUDY ENROLLED 2600 01:39:48,960 --> 01:39:52,120 AS QUICKLY AS POSSIBLE, SO 2601 01:39:52,120 --> 01:39:53,880 ANYONE INTERESTED IN HELPING 2602 01:39:53,880 --> 01:39:56,600 PLEASE VISIT OUR STUDY WEBSITE 2603 01:39:56,600 --> 01:39:59,240 AND -- FOR PATIENTS AND 2604 01:39:59,240 --> 01:40:02,560 POTENTIAL PARTICIPANTS TO THIS 2605 01:40:02,560 --> 01:40:02,880 STUDY. 2606 01:40:02,880 --> 01:40:10,760 LAST BUT NOT LEAST IS THE ACTG 2607 01:40:10,760 --> 01:40:11,760 PLATFORM HUMAN MONKEYPOX STUDY I 2608 01:40:11,760 --> 01:40:12,720 WAS TELLING YOU ABOUT. 2609 01:40:12,720 --> 01:40:15,080 WE WERE ASKED TO EVALUATE TPOXX 2610 01:40:15,080 --> 01:40:18,880 FOR THE OUTPATIENT TREATMENT OF 2611 01:40:18,880 --> 01:40:19,080 MPOX. 2612 01:40:19,080 --> 01:40:20,680 THIS IS ANOTHER GLOBAL STUDY. 2613 01:40:20,680 --> 01:40:22,320 WE ARE CURRENTLY ENROLLING 2614 01:40:22,320 --> 01:40:23,160 PARTICIPANTS ALL THROUGHOUT THE 2615 01:40:23,160 --> 01:40:24,920 U.S. THROUGH A REMOTE ENROLLING 2616 01:40:24,920 --> 01:40:26,760 MECHANISM AND WE ACTUALLY HOPE 2617 01:40:26,760 --> 01:40:33,000 TO OPEN SITES IN BRAZIL, PERU, 2618 01:40:33,000 --> 01:40:34,000 MEXICO, OTHER SITES AROUND THE 2619 01:40:34,000 --> 01:40:35,800 WORLD IN THE VERY NEAR FUTURE. 2620 01:40:35,800 --> 01:40:36,760 THIS IS A VERY IMPORTANT STUDY 2621 01:40:36,760 --> 01:40:38,720 BECAUSE WE ARE ONE OF THE MAIN 2622 01:40:38,720 --> 01:40:40,440 STUDIES GLOBALLY THAT WILL BE 2623 01:40:40,440 --> 01:40:44,040 STUDYING TPOXX FOR THE EFFICACY 2624 01:40:44,040 --> 01:40:44,680 AGAINST MONKEYPOX. 2625 01:40:44,680 --> 01:40:46,880 AND UNLESS WE GET THIS STUDY 2626 01:40:46,880 --> 01:40:50,920 DONE, WE RISK THAT THIS DRUG MAY 2627 01:40:50,920 --> 01:40:52,800 NEVER HAVE TRULY GOOD CLINICAL 2628 01:40:52,800 --> 01:40:57,520 TRIAL DATA TO SUPPORT ITS USE IN 2629 01:40:57,520 --> 01:40:59,480 MONKEYPOX PATIENTS AROUND THE 2630 01:40:59,480 --> 01:41:00,280 WORLD. 2631 01:41:00,280 --> 01:41:00,920 OKAY. 2632 01:41:00,920 --> 01:41:01,880 FINALLY JUST GETTING TO THE END 2633 01:41:01,880 --> 01:41:04,480 OF MY PRESENTATION, I WAS ASKED 2634 01:41:04,480 --> 01:41:06,320 TO TALK A LITTLE BIT ABOUT 2635 01:41:06,320 --> 01:41:07,400 LESSONS LEARNED, AND CERTAINLY 2636 01:41:07,400 --> 01:41:08,800 THERE ARE MANY, MANY LESSONS 2637 01:41:08,800 --> 01:41:09,240 LEARNED. 2638 01:41:09,240 --> 01:41:13,200 I'VE TRIED TO ENCAPSULATE THOSE 2639 01:41:13,200 --> 01:41:14,000 LESSONS IN TWO SLIDES. 2640 01:41:14,000 --> 01:41:17,600 ONE IS WHAT WORKED WELL, AND 2641 01:41:17,600 --> 01:41:20,000 ALSO THE SECOND SLIDE I'LL TALK 2642 01:41:20,000 --> 01:41:22,880 A LITTLE BIT ABOUT WHAT I THINK 2643 01:41:22,880 --> 01:41:24,400 WE COULD DO BETTER FOR THE NEXT 2644 01:41:24,400 --> 01:41:25,080 TIME. 2645 01:41:25,080 --> 01:41:26,400 SOME OF THESE LESSONS ARE 2646 01:41:26,400 --> 01:41:28,040 OBVIOUSLY WE HAVE ALREADY TAKEN 2647 01:41:28,040 --> 01:41:30,320 INTO ACCOUNT AS THROUGH 2648 01:41:30,320 --> 01:41:31,400 SUBSEQUENT CLINICAL TRIALS, BUT 2649 01:41:31,400 --> 01:41:32,920 ONE THING THAT REALLY CAME TO 2650 01:41:32,920 --> 01:41:36,960 THE FORE FORE IS THAT THE ACTG Y 2651 01:41:36,960 --> 01:41:38,960 DID JUST AN AMAZING JOB IN BOTH 2652 01:41:38,960 --> 01:41:40,160 THEIR CLINICAL TRIAL DESIGNS AND 2653 01:41:40,160 --> 01:41:41,560 ALSO THEIR SCIENTIFIC EXPERTISE 2654 01:41:41,560 --> 01:41:43,240 WAS RIGHT ON THE MARK. 2655 01:41:43,240 --> 01:41:44,640 AND EVEN BEYOND THE CLINICAL 2656 01:41:44,640 --> 01:41:47,040 TRIALS THAT WE IMPLEMENTED 2657 01:41:47,040 --> 01:41:52,880 OURSELVES WITH THE ACTG, ACTG 2658 01:41:52,880 --> 01:41:54,680 CLINICAL TRIAL SCIENTISTS AND 2659 01:41:54,680 --> 01:42:00,520 DADAID SCIENTISTS TO HELP DEVELP 2660 01:42:00,520 --> 01:42:03,680 THEIR OWN CLINICAL TRIAL DESIGNS 2661 01:42:03,680 --> 01:42:04,520 BASED ON THEIR EXPERTISE. 2662 01:42:04,520 --> 01:42:06,840 I HAVE TO REALLY GIVE AN 2663 01:42:06,840 --> 01:42:08,160 APPLAUSE TO DAID'S COLLEAGUES 2664 01:42:08,160 --> 01:42:09,680 AND EXPERTS ON THE LEADERSHIP 2665 01:42:09,680 --> 01:42:11,680 OPERATIONAL SIDE WHO REALLY 2666 01:42:11,680 --> 01:42:13,800 WORKED HARD TO MAKE THESE 2667 01:42:13,800 --> 01:42:15,640 CLINICAL TRIALS POSSIBLE AND TO 2668 01:42:15,640 --> 01:42:19,280 GET THEM UP AND GOING IN RECORD 2669 01:42:19,280 --> 01:42:20,000 TIME. 2670 01:42:20,000 --> 01:42:22,240 WE FOUND THAT THE DAID SYSTEM 2671 01:42:22,240 --> 01:42:25,040 WORKS AND IT IS A GOOD SYSTEM. 2672 01:42:25,040 --> 01:42:26,760 THE DAIDS EXPERTS THAT PUT THEIR 2673 01:42:26,760 --> 01:42:28,760 TIME INTO THIS REALLY DID AN 2674 01:42:28,760 --> 01:42:32,240 AMAZING JOB OF GETTING THINGS. 2675 01:42:32,240 --> 01:42:33,960 WE ALSO FOUND THE ROBUST 2676 01:42:33,960 --> 01:42:34,920 FRAMEWORK FOR AGENT SELECTION 2677 01:42:34,920 --> 01:42:36,840 THAT WAS DONE UNDER THE 2678 01:42:36,840 --> 01:42:41,240 FRAMEWORK OF THE ACTIV PPP WAS 2679 01:42:41,240 --> 01:42:42,440 BOTH TIME AND RESOURCE SAVING 2680 01:42:42,440 --> 01:42:44,960 AND I THINK WE COULD NOT HAVE 2681 01:42:44,960 --> 01:42:46,280 FOCUSED ON THE SCIENCE AS WE DID 2682 01:42:46,280 --> 01:42:49,560 UNLESS WE HAD THE COLLABORATION 2683 01:42:49,560 --> 01:42:52,600 FROM THE ACTIV PARTNERS. 2684 01:42:52,600 --> 01:42:55,200 WE FOUND THE BROAD AND LARGE 2685 01:42:55,200 --> 01:42:56,920 GLOBAL ENROLLMENT STRATEGY IS 2686 01:42:56,920 --> 01:42:59,320 ABSOLUTELY NEEDED IF YOU WANT 2687 01:42:59,320 --> 01:43:00,680 RAPID ENROLLMENT. 2688 01:43:00,680 --> 01:43:03,200 AND SO -- BUT WE ALSO FOUND THIS 2689 01:43:03,200 --> 01:43:04,680 PHRASE TO BE TRUE, DON'T CHASE 2690 01:43:04,680 --> 01:43:07,360 THE PANDEMIC, LET IT COME TO 2691 01:43:07,360 --> 01:43:09,240 YOU, AND THIS IS A PHRASE WE 2692 01:43:09,240 --> 01:43:12,800 OFTEN REFER TO, WHEN WE ARE 2693 01:43:12,800 --> 01:43:14,040 COMING UP WITH OUR CLINICAL SITE 2694 01:43:14,040 --> 01:43:14,400 STRATEGY. 2695 01:43:14,400 --> 01:43:15,400 WE FOUND THAT A SITE'S 2696 01:43:15,400 --> 01:43:16,480 INFRASTRUCTURE THAT INCLUDES 2697 01:43:16,480 --> 01:43:17,760 BOTH ACADEMIC AND 2698 01:43:17,760 --> 01:43:21,520 COMMUNITY-BASED RESEARCH SITES 2699 01:43:21,520 --> 01:43:22,760 WAS CRITICAL TO THE SUCCESS OF 2700 01:43:22,760 --> 01:43:23,640 OUR CLINICAL TRIALS, AND LOCAL 2701 01:43:23,640 --> 01:43:25,520 AND COMMUNITY-BASED OUTREACH TO 2702 01:43:25,520 --> 01:43:27,840 DRIVE ENROLLMENTS WAS THE SINGLE 2703 01:43:27,840 --> 01:43:30,880 MOST EFFECTIVE STRATEGY TO DRIVE 2704 01:43:30,880 --> 01:43:32,840 ENROLLMENT INTO OUR TRIALS. 2705 01:43:32,840 --> 01:43:35,080 WE FOUND THAT UTILIZING EXISTING 2706 01:43:35,080 --> 01:43:37,160 PROCESSES AND INFRASTRUCTURE AS 2707 01:43:37,160 --> 01:43:40,680 OPPOSED TO DEVELOPING NEW 2708 01:43:40,680 --> 01:43:41,720 PROCESSES AND INFRASTRUCTURE 2709 01:43:41,720 --> 01:43:45,520 RESULTED IN THE FASTEST TRIAL 2710 01:43:45,520 --> 01:43:46,280 BUILD AND INITIATION. 2711 01:43:46,280 --> 01:43:48,680 ALL OF THESE LESSONS CULMINATED 2712 01:43:48,680 --> 01:43:49,960 INTO THE LAST TRIAL WE'VE 2713 01:43:49,960 --> 01:43:52,120 DEVELOPED AND IMPLEMENTED, AND 2714 01:43:52,120 --> 01:43:53,520 BASED ON THESE LESSONS, WE WERE 2715 01:43:53,520 --> 01:43:57,600 ABLE TO GET THE A5418 TRIAL FROM 2716 01:43:57,600 --> 01:43:59,800 CONCEPT TO FIRST PATIENT IN 2717 01:43:59,800 --> 01:44:00,840 WITHIN SIX WEEKS, WHICH I THINK 2718 01:44:00,840 --> 01:44:03,040 IS A RECORD TIME, AND EVEN OUR 2719 01:44:03,040 --> 01:44:06,160 COLLEAGUES AT THE FDA WERE QUITE 2720 01:44:06,160 --> 01:44:06,840 ASTONISHED AT THE SPEED WITH 2721 01:44:06,840 --> 01:44:08,480 WHICH WE WERE ABLE TO GET THAT 2722 01:44:08,480 --> 01:44:09,200 TRIAL UP AND GOING. 2723 01:44:09,200 --> 01:44:10,560 AND THAT'S BECAUSE OF ALL THE 2724 01:44:10,560 --> 01:44:13,880 LESSONS THAT WE'VE LEARNED TO 2725 01:44:13,880 --> 01:44:15,080 DATE FROM THE PANDEMIC RESPONSE. 2726 01:44:15,080 --> 01:44:16,640 AND LAST BUT NOT LEAST, WE FOUND 2727 01:44:16,640 --> 01:44:19,960 THAT REAL WORLD EVIDENCE WAS 2728 01:44:19,960 --> 01:44:22,160 CRITICAL TO INFORMING OUR TRIAL 2729 01:44:22,160 --> 01:44:25,160 DESIGNS, AND WITHOUT IT, WE 2730 01:44:25,160 --> 01:44:26,200 REALLY WOULD NOT HAVE BEEN ABLE 2731 01:44:26,200 --> 01:44:27,320 TO DO MUCH OF THE WORK WE HAVE 2732 01:44:27,320 --> 01:44:30,600 DONE TO DATE. 2733 01:44:30,600 --> 01:44:33,040 SO SOME OPPORTUNITIES FOR 2734 01:44:33,040 --> 01:44:33,360 IMPROVEMENT. 2735 01:44:33,360 --> 01:44:35,120 AS I DISCUSSED, WE BELIEVE THAT 2736 01:44:35,120 --> 01:44:36,440 A BROAD GLOBAL ENROLLMENT 2737 01:44:36,440 --> 01:44:39,080 STRATEGY IS ABSOLUTELY NEEDED. 2738 01:44:39,080 --> 01:44:41,160 IF YOU WANT TO ENROLL QUICKLY, 2739 01:44:41,160 --> 01:44:42,280 YOU NEED A LOT OF SITE. 2740 01:44:42,280 --> 01:44:43,920 I THINK IT JUST -- YOU KNOW, IT 2741 01:44:43,920 --> 01:44:45,560 JUST MAKES A LOT OF SENSE. 2742 01:44:45,560 --> 01:44:49,840 BUT WE FOUND THAT THE EX--U.S. 2743 01:44:49,840 --> 01:44:52,760 REGULATORY TIME LINES REPRESENT 2744 01:44:52,760 --> 01:44:53,800 SIGNIFICANT DELAYS TO STUDY 2745 01:44:53,800 --> 01:44:54,560 INITIATION. 2746 01:44:54,560 --> 01:44:55,440 OBVIOUSLY IT'S NOT SOMETHING WE 2747 01:44:55,440 --> 01:44:57,360 CAN DO MUCH ABOUT JUST SITTING 2748 01:44:57,360 --> 01:44:58,960 HERE AT NIAID, BUT WE DO THINK 2749 01:44:58,960 --> 01:44:59,960 THAT IT'S SOMETHING THAT WE NEED 2750 01:44:59,960 --> 01:45:01,560 TO CONTINUOUSLY ENGAGE WITH OUR 2751 01:45:01,560 --> 01:45:03,280 GLOBAL PARTNERS TO SEE IF WE 2752 01:45:03,280 --> 01:45:09,640 COULD BRING THESE TIME LINES 2753 01:45:09,640 --> 01:45:12,160 DOWN ALSO BUILDING A NEW AND 2754 01:45:12,160 --> 01:45:12,760 LARGE SITE INFRASTRUCTURE IS 2755 01:45:12,760 --> 01:45:15,800 BOTH TIME AND RESOURCE INTENSIVE 2756 01:45:15,800 --> 01:45:17,000 SO WE NEED TO BE ABLE TO COME UP 2757 01:45:17,000 --> 01:45:18,920 WITH STRATEGIES WHERE WE WILL BE 2758 01:45:18,920 --> 01:45:22,320 ABLE TO ENGAGE THE NEEDED 2759 01:45:22,320 --> 01:45:23,120 INFRASTRUCTURE MUCH MORE QUICKLY 2760 01:45:23,120 --> 01:45:24,320 THAN WE WERE ABLE TO DO AT THE 2761 01:45:24,320 --> 01:45:25,280 BEGINNING OF THIS COVID-19 2762 01:45:25,280 --> 01:45:25,520 PANDEMIC. 2763 01:45:25,520 --> 01:45:28,360 WE NEED TO BE ABLE TO UTILIZE 2764 01:45:28,360 --> 01:45:30,760 EXISTING SYSTEMS AND PROCESSES, 2765 01:45:30,760 --> 01:45:33,200 NOT ONLY WITH THE TRIAL 2766 01:45:33,200 --> 01:45:35,200 INFRASTRUCTURE BUT -- NOT ONLY 2767 01:45:35,200 --> 01:45:36,160 WITH THE SITE INFRASTRUCTURE BUT 2768 01:45:36,160 --> 01:45:37,680 ALSO INCLUDING THE TRIAL 2769 01:45:37,680 --> 01:45:40,840 INFRASTRUCTURE SUCH AS THE STUDY 2770 01:45:40,840 --> 01:45:41,640 DATABASE AND OTHER ASPECTS OF 2771 01:45:41,640 --> 01:45:42,160 THE TRIAL. 2772 01:45:42,160 --> 01:45:43,600 JUST IN EVERY WAY, ANYTHING THAT 2773 01:45:43,600 --> 01:45:45,480 WE DEVELOP NEW, WE FOUND JUST 2774 01:45:45,480 --> 01:45:46,680 ADDED COMPLEXITIES THAT ONE 2775 01:45:46,680 --> 01:45:48,040 COULD NOT HAVE IMAGINED AT THE 2776 01:45:48,040 --> 01:45:49,000 BEGINNING OF THE TRIAL, BUT 2777 01:45:49,000 --> 01:45:50,120 WHICH RESULTED IN SIGNIFICANT 2778 01:45:50,120 --> 01:45:51,360 DELAYS. 2779 01:45:51,360 --> 01:45:56,240 COMPLEX PROTOCOL DESIGNS SI 2780 01:45:56,240 --> 01:46:04,760 SIMILARLY RESULTED IN SIGHT 2781 01:46:04,760 --> 01:46:06,000 STARTUP AND ENROLLMENT CAPACITY 2782 01:46:06,000 --> 01:46:07,880 AND PLATFORM DESIGN DID NOT 2783 01:46:07,880 --> 01:46:08,880 PRODUCE HYPOTHESIZED 2784 01:46:08,880 --> 01:46:12,200 EFFICIENCIES AS WE HAD HOPED, 2785 01:46:12,200 --> 01:46:15,680 HINDERING ABILITY TO ADAPT THE 2786 01:46:15,680 --> 01:46:17,360 TRIAL TO PANDEMIC REALITIES. 2787 01:46:17,360 --> 01:46:18,360 AGAIN, REAL WORLD EVIDENCE IS 2788 01:46:18,360 --> 01:46:21,000 SOMETHING THAT WE FOUND WAS 2789 01:46:21,000 --> 01:46:21,880 CRITICAL TO MANUFACTURING OUR 2790 01:46:21,880 --> 01:46:23,120 TRIAL DESIGNS, AND I HAVE TO SAY 2791 01:46:23,120 --> 01:46:24,880 AT THE BEGINNING OF THE 2792 01:46:24,880 --> 01:46:26,200 PANDEMIC, THE ABSENCE OF REAL 2793 01:46:26,200 --> 01:46:27,720 WORLD EVIDENCE REALLY HAMPERED 2794 01:46:27,720 --> 01:46:29,080 OUR ABILITIES FOR TRIAL DESIGN 2795 01:46:29,080 --> 01:46:32,520 AND AS THIS EVIDENCE BECAME MORE 2796 01:46:32,520 --> 01:46:36,120 AVAILABLE, IT WAS A REAL BOON 2797 01:46:36,120 --> 01:46:38,320 AND IMPORTANT RESOURCE FOR US. 2798 01:46:38,320 --> 01:46:39,560 BUT I THINK IN THE FUTURE, 2799 01:46:39,560 --> 01:46:43,200 TRYING TO GET ACCESS TO THIS 2800 01:46:43,200 --> 01:46:44,480 EVIDENCE FROM THE VERY ONSET OF 2801 01:46:44,480 --> 01:46:47,840 THE PANDEMIC WOULD BE REALLY 2802 01:46:47,840 --> 01:46:48,920 CRITICAL TO HELP US WITH OUR 2803 01:46:48,920 --> 01:46:49,440 TRIAL DESIGNS. 2804 01:46:49,440 --> 01:46:51,760 AND LAST BUT NOT LEAST, WE FOUND 2805 01:46:51,760 --> 01:46:53,960 THAT WE ABSOLUTELY NEED SURGE 2806 01:46:53,960 --> 01:46:54,640 CAPACITY. 2807 01:46:54,640 --> 01:46:56,720 BOTH HUMAN AND STRUCTURAL 2808 01:46:56,720 --> 01:46:57,320 RESOURCES. 2809 01:46:57,320 --> 01:46:59,840 TO ENABLE A RAPID STARTUP OF ANY 2810 01:46:59,840 --> 01:47:03,040 CLINICAL TRIAL THAT WE HAVE, AND 2811 01:47:03,040 --> 01:47:06,320 ALSO TO PRESENT BURNOUT. 2812 01:47:06,320 --> 01:47:07,880 AND I THINK IT GOES WITHOUT 2813 01:47:07,880 --> 01:47:08,760 SAYING THAT EVERY SINGLE PERSON 2814 01:47:08,760 --> 01:47:11,040 THAT WAS COMMITTED TO THE TRIALS 2815 01:47:11,040 --> 01:47:13,560 THAT I'VE DISCUSSED TODAY, THEY 2816 01:47:13,560 --> 01:47:16,200 WERE DOING ALL OF THIS WORK ON 2817 01:47:16,200 --> 01:47:20,440 TOP OF THEIR 40-HOUR WORK WEEKS 2818 01:47:20,440 --> 01:47:22,320 OR 50, 60-HOUR WORK WEEKS, AND 2819 01:47:22,320 --> 01:47:23,560 WE WERE ALL WORKING REALLY HARD 2820 01:47:23,560 --> 01:47:24,680 TO GET THIS UP AND GOING. 2821 01:47:24,680 --> 01:47:26,760 IT WAS POSSIBLE AT THE BEGINNING 2822 01:47:26,760 --> 01:47:28,000 BECAUSE, YOU KNOW, OF JUST WHAT 2823 01:47:28,000 --> 01:47:31,080 THE PANDEMIC REPRESENTED, BUT AS 2824 01:47:31,080 --> 01:47:34,320 THE PANDEMIC WENT ON, I FOUND 2825 01:47:34,320 --> 01:47:36,880 THAT STAFF STARTED TO BURN OUT, 2826 01:47:36,880 --> 01:47:37,920 AND SO I THINK IT'S VERY 2827 01:47:37,920 --> 01:47:40,280 IMPORTANT THAT WE RECOGNIZE THAT 2828 01:47:40,280 --> 01:47:43,120 OUR COLLEAGUES AND OUR 2829 01:47:43,120 --> 01:47:44,120 INVESTIGATOR COLLEAGUES REALLY 2830 01:47:44,120 --> 01:47:45,800 DO HAVE LIMITS AND WE NEED TO 2831 01:47:45,800 --> 01:47:47,040 BUILD IN THE SURGE CAPACITY, 2832 01:47:47,040 --> 01:47:48,800 SHOULD WE NEED THAT CAPACITY IN 2833 01:47:48,800 --> 01:47:52,360 THE FUTURE. 2834 01:47:52,360 --> 01:47:53,480 WITH THAT, I'LL JUST RECOGNIZE 2835 01:47:53,480 --> 01:47:55,240 ALL THE STAFF MEMBERS OF TRP 2836 01:47:55,240 --> 01:47:55,640 AGAIN. 2837 01:47:55,640 --> 01:47:58,520 THEY ARE REALLY THOSE PEOPLE ARE 2838 01:47:58,520 --> 01:47:59,480 THE ONES WHO MAKE THIS ALL 2839 01:47:59,480 --> 01:48:00,040 POSSIBLE. 2840 01:48:00,040 --> 01:48:01,040 AND I'LL TAKE QUESTIONS AND 2841 01:48:01,040 --> 01:48:01,320 DISCUSSION. 2842 01:48:01,320 --> 01:48:04,800 THANK YOU. 2843 01:48:04,800 --> 01:48:05,880 >>THANK YOU, DR. KIM. 2844 01:48:05,880 --> 01:48:06,920 THAT WAS GREAT. 2845 01:48:06,920 --> 01:48:08,720 REALLY IMPRESSIVE, ALL OF THE 2846 01:48:08,720 --> 01:48:11,120 WORK GOING ON. 2847 01:48:11,120 --> 01:48:12,920 IN ADDITION TO THE COVID WORK 2848 01:48:12,920 --> 01:48:16,880 AND HOW QUICKLY AND IMPRESSIVELY 2849 01:48:16,880 --> 01:48:17,400 THAT WAS DONE. 2850 01:48:17,400 --> 01:48:19,960 MONICA, YOU KNOW, I THINK WHAT 2851 01:48:19,960 --> 01:48:23,040 I'D LIKE TO DO IS -- WELL, WHAT 2852 01:48:23,040 --> 01:48:24,000 CAN WE DO HERE? 2853 01:48:24,000 --> 01:48:29,280 MAYBE WE'LL TAKE TWO -- MONICA 2854 01:48:29,280 --> 01:48:30,040 PASSED? 2855 01:48:30,040 --> 01:48:32,160 OKAY, DR. HARRIS, ONE QUESTION, 2856 01:48:32,160 --> 01:48:33,440 THEN WE'RE GOING TO TAKE A 2857 01:48:33,440 --> 01:48:34,240 FIVE-MINUTE BREAK AND WE WILL 2858 01:48:34,240 --> 01:48:35,720 CATCH UP THE TIME, I AM CERTAIN. 2859 01:48:35,720 --> 01:48:38,520 >>SO I JUST WANTED TO COMMENT 2860 01:48:38,520 --> 01:48:39,640 AND QUICK QUESTION ON 2861 01:48:39,640 --> 01:48:41,720 RESISTANCE. 2862 01:48:41,720 --> 01:48:45,040 SO WITH ZICOVAK, THE RESISTANCE 2863 01:48:45,040 --> 01:48:46,240 PROFILE IS DIFFERENT THAN 2864 01:48:46,240 --> 01:48:46,520 PAXLOVID. 2865 01:48:46,520 --> 01:48:48,680 THERE'S A FEW STUDIES INCLUDING 2866 01:48:48,680 --> 01:48:49,760 A BIOARCHIVE FROM US THAT SAYS 2867 01:48:49,760 --> 01:48:51,560 THAT SO I THINK IT'S GREAT THAT 2868 01:48:51,560 --> 01:48:52,600 OTHER DRUGS ARE MOVING WITH 2869 01:48:52,600 --> 01:48:53,360 DIFFERENT PROFILES. 2870 01:48:53,360 --> 01:48:55,720 AND THE OTHER IS ON 2871 01:48:55,720 --> 01:48:56,560 TUBERCULOSIS, SO I THOUGHT THAT 2872 01:48:56,560 --> 01:48:57,960 WAS REALLY INTERESTING, I WAS 2873 01:48:57,960 --> 01:48:58,960 WONDERING WHAT THE RESISTANCE IS 2874 01:48:58,960 --> 01:49:00,480 LIKE IN THOSE DRUGS THAT ARE AT 2875 01:49:00,480 --> 01:49:02,600 THE FRONT, LIKE PHASE III AND 2876 01:49:02,600 --> 01:49:03,680 ALREADY APPROVED. 2877 01:49:03,680 --> 01:49:05,680 IS THAT A PROBLEM? 2878 01:49:05,680 --> 01:49:06,960 >>THANK YOU FOR THAT QUESTION. 2879 01:49:06,960 --> 01:49:08,280 IT'S A GREAT QUESTION. 2880 01:49:08,280 --> 01:49:10,960 AND THE ANSWER IS, IT'S NOT A 2881 01:49:10,960 --> 01:49:12,280 GLOBAL PROBLEM YET, BUT IT'S 2882 01:49:12,280 --> 01:49:13,280 BECOMING A PROBLEM. 2883 01:49:13,280 --> 01:49:17,520 SO FOR EXAMPLE, ONE OF THE NEW 2884 01:49:17,520 --> 01:49:18,960 DRUGS AND MOST EFFECTIVE DRUGS 2885 01:49:18,960 --> 01:49:20,960 THAT ARE NOW AVAILABLE FOR 2886 01:49:20,960 --> 01:49:26,560 MULTIDRUG RESISTANCE TB ALREADY 2887 01:49:26,560 --> 01:49:27,880 HAS RESISTANCE IN SOME PART OF 2888 01:49:27,880 --> 01:49:28,600 THE WORLD. 2889 01:49:28,600 --> 01:49:31,200 SO WE ARE REALLY WORKING HARD TO 2890 01:49:31,200 --> 01:49:33,840 MAKE SURE THAT THE RESISTANCE 2891 01:49:33,840 --> 01:49:35,720 TESTING THAT NEEDS TO BE PAIRED 2892 01:49:35,720 --> 01:49:38,680 AND DEVELOPED TOGETHER WITH DRUG 2893 01:49:38,680 --> 01:49:39,640 DEVELOPMENT IS HAPPENING AT THE 2894 01:49:39,640 --> 01:49:41,520 SAME TIME. 2895 01:49:41,520 --> 01:49:43,280 AND WE ARE ALL AFRAID THAT 2896 01:49:43,280 --> 01:49:45,080 UNLESS WE DO THAT, THAT WE WILL 2897 01:49:45,080 --> 01:49:46,920 LOSE THESE DRUGS VERY QUICKLY. 2898 01:49:46,920 --> 01:49:47,920 >>SUPER. 2899 01:49:47,920 --> 01:49:48,960 THANK YOU. 2900 01:49:48,960 --> 01:49:49,960 >>GREAT. 2901 01:49:49,960 --> 01:49:51,760 THANK YOU. 2902 01:49:51,760 --> 01:49:52,640 THANKS, EVERYONE, FOR YOUR 2903 01:49:52,640 --> 01:49:53,200 PRESENTATIONS. 2904 01:49:53,200 --> 01:49:55,480 WHY DON'T WE TAKE A FIVE-MINUTE 2905 01:49:55,480 --> 01:50:00,600 BREAK AND COME BACK AT 2:54 AND 2906 01:50:00,600 --> 01:50:02,200 WE'LL GET STARTED AND WE'LL PICK 2907 01:50:02,200 --> 01:50:04,960 UP THE FOUR MINUTES. 2908 01:50:04,960 --> 01:50:07,280 THANKS, EVERYONE. 2909 01:50:07,280 --> 01:50:08,600 FIVE-MINUTE BREAK. 2910 01:50:08,600 --> 01:50:09,800 >>WE ARE BACK. 2911 01:50:09,800 --> 01:50:12,680 I REALIZE -- THAT WAS PROBABLY 2912 01:50:12,680 --> 01:50:16,200 NOT A REASONABLE THING TO DO, TO 2913 01:50:16,200 --> 01:50:17,480 ASK PEOPLE TO TAKE A FIVE-MINUTE 2914 01:50:17,480 --> 01:50:17,920 BREAK. 2915 01:50:17,920 --> 01:50:19,440 I REALIZED IT AFTER I SAID IT 2916 01:50:19,440 --> 01:50:21,480 AND THE CLOCK WAS GOING, I 2917 01:50:21,480 --> 01:50:24,360 THOUGHT, HMM, HOW DOES ONE UNDO 2918 01:50:24,360 --> 01:50:24,800 THAT. 2919 01:50:24,800 --> 01:50:26,240 SO FOR THOSE WHO THOUGHT THAT 2920 01:50:26,240 --> 01:50:27,760 WAS VERY UNREASONABLE, I 2921 01:50:27,760 --> 01:50:32,280 APOLOGIZE. 2922 01:50:32,280 --> 01:50:33,600 HOPEFULLY THEY'RE NOT BACK YET 2923 01:50:33,600 --> 01:50:38,120 AND WITH W WILL ARRIVE. 2924 01:50:38,120 --> 01:50:40,000 BUT LET US CONTINUE AND MOVE TO 2925 01:50:40,000 --> 01:50:41,440 THE VACCINE RESEARCH PROGRAM AND 2926 01:50:41,440 --> 01:50:42,640 DR. MARY MAROVICH. 2927 01:50:42,640 --> 01:50:48,000 AND WE LOOK FORWARD TO HEARING 2928 01:50:48,000 --> 01:50:50,120 YOUR PRESENTATION, AND AGAIN MY 2929 01:50:50,120 --> 01:50:51,880 APOLOGIES TO THOSE WHO ARE 2930 01:50:51,880 --> 01:50:52,320 RUSHING BACK. 2931 01:50:52,320 --> 01:50:55,760 >>THANKS SO MUCH, KEN. 2932 01:50:55,760 --> 01:50:56,840 REALLY SAD TO SEE THIS WILL BE 2933 01:50:56,840 --> 01:50:58,040 OUR LAST TIME TOGETHER. 2934 01:50:58,040 --> 01:51:04,080 APPRECIATE YOUR CHAIR HERE. 2935 01:51:04,080 --> 01:51:05,120 GOOD AFTERNOON. 2936 01:51:05,120 --> 01:51:07,920 IT'S MY PLEASURE TO PROVIDE THE 2937 01:51:07,920 --> 01:51:10,200 ANNUAL OVERVIEW ON THE VACCINE 2938 01:51:10,200 --> 01:51:11,240 RESEARCH PROGRAM AND SOME OF THE 2939 01:51:11,240 --> 01:51:13,120 EXCITING WORK THAT'S BEEN DONE 2940 01:51:13,120 --> 01:51:18,720 IN THE PROGRAM. 2941 01:51:18,720 --> 01:51:19,920 FIRST I'LL TALK BASICALLY ABOUT 2942 01:51:19,920 --> 01:51:23,320 THE PROGRAM MISSION AND PROVIDE 2943 01:51:23,320 --> 01:51:25,200 SOME HIGHLIGHTS ON THE U.S. 2944 01:51:25,200 --> 01:51:25,840 GOVERNMENT COVID-19 RESPONSE IN 2945 01:51:25,840 --> 01:51:28,200 TERMS OF THE VACCINE WORK, AND 2946 01:51:28,200 --> 01:51:32,120 THEN I'LL DIVE DEEPLY INTO OUR 2947 01:51:32,120 --> 01:51:33,880 HIV VACCINE STRATEGY, 2948 01:51:33,880 --> 01:51:34,800 PARTICULARLY IN DISCOVERY AND 2949 01:51:34,800 --> 01:51:36,120 DESIGN WHICH WILL INVOLVE A LOT 2950 01:51:36,120 --> 01:51:38,440 OF NON-HUMAN PRIMATE ANIMAL 2951 01:51:38,440 --> 01:51:39,560 STUDIES. 2952 01:51:39,560 --> 01:51:42,640 I'LL MAKE SURE I POINT THOSE OUT 2953 01:51:42,640 --> 01:51:43,920 TO, YOU AND HOW WE USE THAT 2954 01:51:43,920 --> 01:51:45,400 INFORMATION MOVING INTO OUR 2955 01:51:45,400 --> 01:51:46,600 VACCINE CONCEPTS IN CLINICAL 2956 01:51:46,600 --> 01:51:47,920 TESTING AND THEN GO OVER SOME 2957 01:51:47,920 --> 01:51:57,000 FUTURE DIRECTIONS FOR VACCINES. 2958 01:51:57,000 --> 01:51:58,080 BEFORE I MOVE INTO THE BULK OF 2959 01:51:58,080 --> 01:51:59,600 THE PRESENTATION, I'D LIKE TO 2960 01:51:59,600 --> 01:52:00,480 PROVIDE ACKNOWLEDGMENTS BECAUSE 2961 01:52:00,480 --> 01:52:01,360 THEY ARE VERY IMPORTANT AND I 2962 01:52:01,360 --> 01:52:02,440 DON'T WANT TO NOT HAVE ENOUGH 2963 01:52:02,440 --> 01:52:10,040 TIME FOR THAT. 2964 01:52:10,040 --> 01:52:13,600 FIRFIRST I'D THANK THE PEOPLE WO 2965 01:52:13,600 --> 01:52:18,400 MAKE THIS WORK POSSIBLE, NIAID 2966 01:52:18,400 --> 01:52:20,280 AND DAIDS SENIOR MANAGEMENT, AND 2967 01:52:20,280 --> 01:52:22,560 OF COURSE I'D LIKE TO CALL OUT 2968 01:52:22,560 --> 01:52:24,360 ALL THE HARD WORKING AND 2969 01:52:24,360 --> 01:52:25,440 DEDICATED MEMBERS OF THE VACCINE 2970 01:52:25,440 --> 01:52:26,840 RESEARCH PROGRAM THAT ARE SHOWN 2971 01:52:26,840 --> 01:52:33,640 HERE WHO HAVE NOT ONLY 2972 01:52:33,640 --> 01:52:34,680 CONTRIBUTED SUBSTANTIALLY TO THE 2973 01:52:34,680 --> 01:52:35,600 COVID-19 RESPONSE, BUT THEY 2974 01:52:35,600 --> 01:52:37,440 ACTUALLY KEPT ALL THE HIV 2975 01:52:37,440 --> 01:52:39,080 SCIENCE MOVING FORWARD, WHICH IS 2976 01:52:39,080 --> 01:52:40,560 REALLY REMARKABLE DURING THESE 2977 01:52:40,560 --> 01:52:44,840 VERY CHALLENGING THREE YEARS. 2978 01:52:44,840 --> 01:52:49,080 LASTLY I WANT TO THANK ALL OUR 2979 01:52:49,080 --> 01:52:52,680 NIAID-FUNDED NETWORK, PRINCIPAL 2980 01:52:52,680 --> 01:52:55,400 INVESTIGATORS, LABS, SITES AND 2981 01:52:55,400 --> 01:52:56,960 PARTNERS AND STUDY PARTICIPANTS 2982 01:52:56,960 --> 01:52:58,120 AND COMMUNITY MEMBERS BECAUSE 2983 01:52:58,120 --> 01:52:58,960 WITHOUT THEM, NONE OF THIS WOULD 2984 01:52:58,960 --> 01:53:00,040 BE POSSIBLE, SO THANKS VERY MUCH 2985 01:53:00,040 --> 01:53:02,080 TO ALL OF YOU. 2986 01:53:02,080 --> 01:53:02,640 OKAY. 2987 01:53:02,640 --> 01:53:04,200 SO WE CAN GO TO THE NEXT SLIDE 2988 01:53:04,200 --> 01:53:07,880 AND TALK ABOUT THE MISSION AND 2989 01:53:07,880 --> 01:53:08,760 ORGANIZATION. 2990 01:53:08,760 --> 01:53:10,280 OBVIOUSLY OUR GOAL IS TO DEVELOP 2991 01:53:10,280 --> 01:53:12,480 A SAFE AND EFFECTIVE HIV 2992 01:53:12,480 --> 01:53:12,920 VACCINE. 2993 01:53:12,920 --> 01:53:17,120 WE ARE COMPRISED OF REALLY -- WE 2994 01:53:17,120 --> 01:53:18,560 HAVE A PRE-CLINICAL RESEARCH AND 2995 01:53:18,560 --> 01:53:19,480 DEVELOPMENT BRANCH WHICH WORKS A 2996 01:53:19,480 --> 01:53:21,720 LOT IN THE DISCOVERY AND DESIGN 2997 01:53:21,720 --> 01:53:22,920 AREA, A LOT OF ANIMAL WORK IS 2998 01:53:22,920 --> 01:53:28,360 DONE THERE. 2999 01:53:28,360 --> 01:53:30,560 WE'RE LUCKY ENOUGH TO HAVE A 3000 01:53:30,560 --> 01:53:33,400 VACCINE TRANSLATIONAL BRANCH 3001 01:53:33,400 --> 01:53:36,600 WHICH -- DOES A LOT OF THE PROCS 3002 01:53:36,600 --> 01:53:37,560 DEVELOPMENT, PRODUCT DEVELOPMENT 3003 01:53:37,560 --> 01:53:40,400 AND IMPORTANTLY THE GMP 3004 01:53:40,400 --> 01:53:41,000 MANUFACTURING BECAUSE THAT'S 3005 01:53:41,000 --> 01:53:41,880 WHERE MOST OF THE PRODUCTS COME 3006 01:53:41,880 --> 01:53:44,080 THAT WE TEST IN OUR VACCINE 3007 01:53:44,080 --> 01:53:46,120 CLINICAL RESEARCH BRANCH, THE 3008 01:53:46,120 --> 01:53:49,240 THIRD BRANCH, WHERE ALL THE 3009 01:53:49,240 --> 01:53:51,200 CLINICAL TRIALS ARE MANAGED AND 3010 01:53:51,200 --> 01:53:54,920 OF COURSE THE IMMUNE 3011 01:53:54,920 --> 01:53:55,680 LABORATORIES ARE OVERSEEN THERE 3012 01:53:55,680 --> 01:53:57,360 AND THE CLINICAL LABORATORIES 3013 01:53:57,360 --> 01:53:59,800 THAT ARE THE ENGINES THAT MAKE 3014 01:53:59,800 --> 01:54:01,000 OUR CLINICAL TRIALS RUN AND HELP 3015 01:54:01,000 --> 01:54:08,440 US UNDERSTAND THE RESULTS. 3016 01:54:08,440 --> 01:54:10,320 THIS IS A REALLY STRONG 3017 01:54:10,320 --> 01:54:11,400 COLLECTION OF DEDICATED 3018 01:54:11,400 --> 01:54:13,120 CLINICIANS AND SCIENTISTS WHO 3019 01:54:13,120 --> 01:54:15,480 PROMOTE THESE RESEARCH 3020 01:54:15,480 --> 01:54:17,920 PORTFOLIOS AND THE SCIENCE AND 3021 01:54:17,920 --> 01:54:20,680 DATABASE DECISION-MAKING TO 3022 01:54:20,680 --> 01:54:21,840 BRING THESE CONCEPTS FROM THE 3023 01:54:21,840 --> 01:54:23,760 BENCH TO THE CLINIC. 3024 01:54:23,760 --> 01:54:28,480 THANK YOU ALL. 3025 01:54:28,480 --> 01:54:33,200 SO NOW I'LL TALK ABOUT THE U.S. 3026 01:54:33,200 --> 01:54:41,320 GOVERNMENT COVID-19 [INAUDIBLE]. 3027 01:54:41,320 --> 01:54:42,440 DR. DIEFFENBACH GAVE A BEAUTIFUL 3028 01:54:42,440 --> 01:54:43,960 OVERVIEW OF THIS SLIDE. 3029 01:54:43,960 --> 01:54:46,280 THIS REPRESENTS THE OPERATION 3030 01:54:46,280 --> 01:54:48,960 WARP SPEED SUITE OF VACCINES 3031 01:54:48,960 --> 01:54:51,360 THAT WERE DEVELOPED UNDER THE 3032 01:54:51,360 --> 01:54:55,240 USG WITH THE EXCEPTION OF THE 3033 01:54:55,240 --> 01:54:56,320 PFIZER BIONTECH, WE DID NOT PLAY 3034 01:54:56,320 --> 01:54:57,080 MUCH OF A ROLE. 3035 01:54:57,080 --> 01:54:58,480 BUT I WANT TO DRAW YOUR 3036 01:54:58,480 --> 01:54:59,120 ATTENTION TO THE FACT THAT THERE 3037 01:54:59,120 --> 01:55:00,760 WERE REALLY THREE MAJOR PLATFORM 3038 01:55:00,760 --> 01:55:01,520 TYPES THAT WE USED. 3039 01:55:01,520 --> 01:55:03,520 THERE WAS THE NUCLEIC ACID WITH 3040 01:55:03,520 --> 01:55:05,720 THE MRNAs, THE VIRAL VECTORS, 3041 01:55:05,720 --> 01:55:14,880 IN PARTICULAR HERE THE 3042 01:55:14,880 --> 01:55:18,280 ADENOVIRUSES AND -- FORTUNATELY 3043 01:55:18,280 --> 01:55:20,600 THESE LED TO HIGHLY EFFICACIOUS 3044 01:55:20,600 --> 01:55:23,640 VACCINES WITH REGULATORY 3045 01:55:23,640 --> 01:55:25,440 SUBMISSIONS, EMERGENCY USE 3046 01:55:25,440 --> 01:55:27,040 AUTHORIZATIONS, LICENSURE -- IN 3047 01:55:27,040 --> 01:55:32,360 THE FIGHT AGAINST COVID-19. 3048 01:55:32,360 --> 01:55:34,800 PERHAPS ONE OF THE KEY LESSONS, 3049 01:55:34,800 --> 01:55:36,440 THOUGH, THAT WE'VE LEARNED FROM 3050 01:55:36,440 --> 01:55:39,320 THIS USG COVID RESPONSE IS THE 3051 01:55:39,320 --> 01:55:43,160 POWER OF LEVERAGING NIAID'S 3052 01:55:43,160 --> 01:55:43,400 ASSETS. 3053 01:55:43,400 --> 01:55:45,040 AN EXAMPLE, A REALLY GOOD 3054 01:55:45,040 --> 01:55:47,800 EXAMPLE OF ONE OF NIAID'S ASSETS 3055 01:55:47,800 --> 01:55:51,560 IS THE COLLECTIVE POWER AND 3056 01:55:51,560 --> 01:55:53,000 EFFORT OF OUR CLINICAL TRIAL 3057 01:55:53,000 --> 01:55:55,720 NETWORKS. 3058 01:55:55,720 --> 01:55:57,160 AND DR. DIEFFENBACH DESCRIBED 3059 01:55:57,160 --> 01:55:59,040 THE COVID-19 PREVENTION NETWORK 3060 01:55:59,040 --> 01:56:04,000 OR THE COVPN, AND THIS WAS A 3061 01:56:04,000 --> 01:56:06,680 GROUP OF ENORMOUSLY TALENTED AND 3062 01:56:06,680 --> 01:56:09,720 DEDICATED RESEARCHERS FROM THE 3063 01:56:09,720 --> 01:56:15,960 ACGG, BASICALLY THE NIAID-FUNDED 3064 01:56:15,960 --> 01:56:17,960 CLINICAL TRIAL NETWORKS CAME 3065 01:56:17,960 --> 01:56:19,120 TOGETHER AND PULLED OFF ALL 3066 01:56:19,120 --> 01:56:21,200 THESE STUDIES AND CONTRIBUTED IN 3067 01:56:21,200 --> 01:56:21,960 A MAJOR WAY. 3068 01:56:21,960 --> 01:56:25,800 THE STUDY STARTED IN JULY OF 3069 01:56:25,800 --> 01:56:28,880 2020, AND YOU CAN SEE ALONG THE 3070 01:56:28,880 --> 01:56:31,280 BOTTOM ROW THEY STILL CONTINUE 3071 01:56:31,280 --> 01:56:34,520 AT THIS TIME IN FOLLOW-UP. 3072 01:56:34,520 --> 01:56:36,840 THESE WERE EXTREMELY LARGE 3073 01:56:36,840 --> 01:56:38,120 STUDY, ON AVERAGE ABOUT 30,000 3074 01:56:38,120 --> 01:56:41,760 PARTICIPANTS IN EACH STUDY, AND 3075 01:56:41,760 --> 01:56:42,840 WE KNOW ALL THE INVESTMENTS IN 3076 01:56:42,840 --> 01:56:46,720 THE NIAID CLINICAL STRUCTURE -- 3077 01:56:46,720 --> 01:56:48,280 WERE LEVERAGED TO MAKE THESE 3078 01:56:48,280 --> 01:56:53,720 TRIALS A SUCCESS. 3079 01:56:53,720 --> 01:56:56,320 WE CURRENTLY HAVE FOUR OF THESE 3080 01:56:56,320 --> 01:56:57,320 VACCINES AVAILABLE IN THE U.S. 3081 01:56:57,320 --> 01:57:02,640 MANY ARE AVAILABLE GLOBALLY. 3082 01:57:02,640 --> 01:57:03,240 ABOUT 230 MILLION PEOPLE HAVE 3083 01:57:03,240 --> 01:57:04,280 COMPLETED THEIR PRIMARY SERIES 3084 01:57:04,280 --> 01:57:06,000 IN THE U.S. AND OVER 50 MILLION 3085 01:57:06,000 --> 01:57:16,400 HAVE RECEIVED -- VACCINE 3086 01:57:19,720 --> 01:57:21,640 ENTERPRISE FOR THE COVID -- NEXT 3087 01:57:21,640 --> 01:57:22,960 SLIDE -- FOR THE COVID VACCINE 3088 01:57:22,960 --> 01:57:26,760 RESEARCH. 3089 01:57:26,760 --> 01:57:28,600 SO AGAIN WE ACKNOWLEDGE THAT THE 3090 01:57:28,600 --> 01:57:33,600 HIV VACCINE RESEARCH ENTERPRISE 3091 01:57:33,600 --> 01:57:34,440 PLAYED A VERY FAVORABLE ROLE IN 3092 01:57:34,440 --> 01:57:35,960 THE SUCCESS OF THE COVID 3093 01:57:35,960 --> 01:57:37,200 RESPONSE, MANY FOLKS HAVE SAID 3094 01:57:37,200 --> 01:57:40,160 THAT TODAY, AND I'D JUST SECOND 3095 01:57:40,160 --> 01:57:40,800 THAT. 3096 01:57:40,800 --> 01:57:43,280 WE RELIED ON PUBLIC-PRIVATE 3097 01:57:43,280 --> 01:57:44,000 PARTNERSHIPS AS WE'RE FAMILIAR 3098 01:57:44,000 --> 01:57:45,160 WITH USING AT LEAST IN OUR 3099 01:57:45,160 --> 01:57:46,680 PROGRAM, AND WE UNDERSTOOD THE 3100 01:57:46,680 --> 01:57:48,240 IMPORTANCE OF TRUST AND 3101 01:57:48,240 --> 01:57:48,600 TRANSPARENCY. 3102 01:57:48,600 --> 01:57:49,920 WE'VE ALL BEEN WORKING IN THE 3103 01:57:49,920 --> 01:57:50,920 HIV VACCINE FIELD AND WE KNOW 3104 01:57:50,920 --> 01:57:55,720 HOW IMPORTANT THAT IS TO ENGAGE 3105 01:57:55,720 --> 01:57:57,080 COMMUNITIES OR RETAIN THEIR 3106 01:57:57,080 --> 01:58:02,920 PARTICIPATION. 3107 01:58:02,920 --> 01:58:05,800 WE ALSO -- I'LL DRAW CONCLUSION 3108 01:58:05,800 --> 01:58:07,720 IN HOW POWERFUL THAT WAS TO 3109 01:58:07,720 --> 01:58:09,640 LEVEL THE PLAYING FIELD WHICH 3110 01:58:09,640 --> 01:58:13,560 ENABLES POWER SHARING AND TO 3111 01:58:13,560 --> 01:58:14,880 MAKE DECISIONS AND THE CLINICAL 3112 01:58:14,880 --> 01:58:17,240 TRIAL INFRASTRUCTURE WAS JUST 3113 01:58:17,240 --> 01:58:17,680 INVALUABLE. 3114 01:58:17,680 --> 01:58:20,240 ALL OF OUR NETWORKS, WE HAVE A 3115 01:58:20,240 --> 01:58:22,920 GLOBAL FOOTPRINT, AND THESE 3116 01:58:22,920 --> 01:58:23,960 RESEARCH SITES AND INVESTIGATORS 3117 01:58:23,960 --> 01:58:26,800 WERE ABLE TO PIVOT ON A DIME TO 3118 01:58:26,800 --> 01:58:29,480 BE ABLE TO USE THEIR EXPERTISE 3119 01:58:29,480 --> 01:58:31,160 IN DEVELOPING THESE VACCINES. 3120 01:58:31,160 --> 01:58:33,880 AND FINALLY, WE SEE THIS 3121 01:58:33,880 --> 01:58:34,960 SPILLOVER EFFECT WHICH MANY HAVE 3122 01:58:34,960 --> 01:58:40,760 TALKED ABOUT THIS -- YEAR 3123 01:58:40,760 --> 01:58:41,880 INVESTMENT IN BASIC SCIENCE AND 3124 01:58:41,880 --> 01:58:45,320 SOME OF THE CONTRIBUTIONS THAT 3125 01:58:45,320 --> 01:58:49,840 FACILITATE COVID COVID-19 VACCIE 3126 01:58:49,840 --> 01:58:50,480 RESPONSES, FOR EXAMPLE -- WHERE 3127 01:58:50,480 --> 01:58:52,080 HE KNEW FROM WORKING ON RSV AND 3128 01:58:52,080 --> 01:58:53,560 HIV THAT YOU NEEDED TO STABILIZE 3129 01:58:53,560 --> 01:58:55,920 THE TRIMERIC ENVELOPE, THE 3130 01:58:55,920 --> 01:58:58,200 SPIKE, AND SO FIVE OUT OF SIX 3131 01:58:58,200 --> 01:58:59,640 VACCINES FROM OPERATION WARP 3132 01:58:59,640 --> 01:59:05,520 SPEED ACTUALLY USED THAT EXACT 3133 01:59:05,520 --> 01:59:07,840 SUP THAT BARNEY DEVELOPED. 3134 01:59:07,840 --> 01:59:11,280 WE USE STANDARDIZED, VALIDATED 3135 01:59:11,280 --> 01:59:13,160 IMMUNE ASSAYS, WE PROMOTED DATA 3136 01:59:13,160 --> 01:59:14,240 SHARING AND OF COURSE WE WERE 3137 01:59:14,240 --> 01:59:16,440 ABLE TO CONTRIBUTE TO THE 3138 01:59:16,440 --> 01:59:18,320 IDENTIFICATION OF CORRELATES OF 3139 01:59:18,320 --> 01:59:19,640 PROTECTION IN ALL FIVE OF THESE 3140 01:59:19,640 --> 01:59:24,560 STUDIES. 3141 01:59:24,560 --> 01:59:26,200 SO WITH THINK WE'RE WELL 3142 01:59:26,200 --> 01:59:27,800 POSITIONED TO ADAPT AND IMPROVE 3143 01:59:27,800 --> 01:59:36,160 ON THE COVID-19 EXPERIENCE. 3144 01:59:36,160 --> 01:59:37,320 HERE I WANTED TO DRILL DOWN A 3145 01:59:37,320 --> 01:59:39,280 LITTLE BIT ON WHAT DIDN'T GO SO 3146 01:59:39,280 --> 01:59:40,680 WELL AND WHERE WE CAN IMPROVE. 3147 01:59:40,680 --> 01:59:42,960 SOME OF THESE WERE MENTIONED IN 3148 01:59:42,960 --> 01:59:44,200 THE PREVIOUS SLIDE, PUBLIC 3149 01:59:44,200 --> 01:59:46,560 PRIVATE PARTNERSHIPS. 3150 01:59:46,560 --> 01:59:51,920 HERE WITH VACCINE, WE USE 3151 01:59:51,920 --> 01:59:53,520 SEPARATE -- WAS A SEPARATE 3152 01:59:53,520 --> 01:59:53,800 PROTOCOL. 3153 01:59:53,800 --> 01:59:55,480 RUN BY A DIFFERENT SPONSOR. 3154 01:59:55,480 --> 01:59:57,080 BUT THEY WERE HARMONIZED. 3155 01:59:57,080 --> 01:59:59,960 WE USED SIMILAR TRIAL ELEMENT, 3156 01:59:59,960 --> 02:00:02,880 WE USED SIMILAR END POINTS, WE 3157 02:00:02,880 --> 02:00:05,240 USED SINGLE DSMB TO ANALYZE ALL 3158 02:00:05,240 --> 02:00:06,760 THE IMMUNE RESPONSES, AND THOSE 3159 02:00:06,760 --> 02:00:08,680 SAME LABS WERE ABLE TO DEVELOP 3160 02:00:08,680 --> 02:00:09,760 THE IMMUNE CORRELATES OF 3161 02:00:09,760 --> 02:00:10,360 PROTECTION. 3162 02:00:10,360 --> 02:00:12,600 I'D LIKE TO CALL OUT ONE 3163 02:00:12,600 --> 02:00:13,800 INVESTIGATOR IN PARTICULAR, 3164 02:00:13,800 --> 02:00:18,680 THAT'S DR. DAVID MONTEFURE WHO 3165 02:00:18,680 --> 02:00:21,480 REPURPOSED HIS HIV PSEUDOVIRUS 3166 02:00:21,480 --> 02:00:25,240 NEUTRALIZATION ASSAY TO BECOME A 3167 02:00:25,240 --> 02:00:26,720 VAL -- WHICH WAS THEN USED TO, 3168 02:00:26,720 --> 02:00:34,720 IN FACT -- FOR REG L REGULATORSE 3169 02:00:34,720 --> 02:00:36,520 DEES KATE -- AS A RESULT AND 3170 02:00:36,520 --> 02:00:39,520 ALSO TO HELP US APPROVE A 3171 02:00:39,520 --> 02:00:41,480 BIVALENT VACCINE ON THE BASIS OF 3172 02:00:41,480 --> 02:00:45,720 THAT NEUTRALIZATION ASSAY. 3173 02:00:45,720 --> 02:00:47,360 SOME OF THE AREAS WHERE WE CAN 3174 02:00:47,360 --> 02:00:48,640 IMPROVE, WE DEFINITELY NEED TO 3175 02:00:48,640 --> 02:00:49,760 ACCELERATE PANDEMIC RESPONSE 3176 02:00:49,760 --> 02:00:51,000 FUNDING AND ITS DISTRIBUTION. 3177 02:00:51,000 --> 02:00:53,000 I THINK THAT'S A MESSAGE THAT'S 3178 02:00:53,000 --> 02:00:53,760 COME THROUGH LOUD AND CLEAR 3179 02:00:53,760 --> 02:00:54,200 TODAY. 3180 02:00:54,200 --> 02:00:56,080 WE THINK WE SHOULD MAINTAIN A 3181 02:00:56,080 --> 02:00:57,280 CORE PANDEMIC RESPONSE STAFF. 3182 02:00:57,280 --> 02:00:59,240 WE NEED TO KEEP READY THE GLOBAL 3183 02:00:59,240 --> 02:01:00,520 CLINICAL TRIAL SITE CAPACITY, 3184 02:01:00,520 --> 02:01:02,680 MAINTAIN A CLINICAL TRIAL 3185 02:01:02,680 --> 02:01:04,480 REGISTRY, AND WE NEED TO 3186 02:01:04,480 --> 02:01:06,760 ESTABLISH METRICS FOR DIVERSITY 3187 02:01:06,760 --> 02:01:09,320 IN ENROLLMENT RIGHT UP FRONT. 3188 02:01:09,320 --> 02:01:18,760 WE CAN EXPEDITE IRB PRIORITY 3189 02:01:18,760 --> 02:01:19,800 REVIEWS, BIOSPECIMEN AND DATA 3190 02:01:19,800 --> 02:01:23,320 OWNOWNERSHIP AND ENSURE NIAID 3191 02:01:23,320 --> 02:01:24,800 CLINICAL RESEARCH IS CARRIED ON 3192 02:01:24,800 --> 02:01:26,440 POST EUA. 3193 02:01:26,440 --> 02:01:27,720 THERE'S A LOT OF QUESTIONS THAT 3194 02:01:27,720 --> 02:01:29,440 REMAIN AFTER THESE VACCINES WERE 3195 02:01:29,440 --> 02:01:30,320 AUTHORIZED AND WE NEED TO MAKE 3196 02:01:30,320 --> 02:01:32,160 SURE THAT NIAID HAS ACCESS AND 3197 02:01:32,160 --> 02:01:34,480 INVESTIGATORS HAVE ACCESS TO 3198 02:01:34,480 --> 02:01:38,360 CONTINUE THAT STUDY. 3199 02:01:38,360 --> 02:01:43,600 THE FINAL SLIDE I WILL PRESENT 3200 02:01:43,600 --> 02:01:52,880 HERE ON COVPN IN NATURE 2022, 3201 02:01:52,880 --> 02:01:54,080 THEY HAD A REVIEW ARTICLE WHERE 3202 02:01:54,080 --> 02:01:55,400 THEY LISTED 11 CLINICAL TRIALS 3203 02:01:55,400 --> 02:01:56,800 THAT WILL SHAPE MEDICINE IN 3204 02:01:56,800 --> 02:01:57,360 2023. 3205 02:01:57,360 --> 02:01:59,400 AT LEAST ACCORDING TO NATURE 3206 02:01:59,400 --> 02:02:03,400 MEDICINE. 3207 02:02:03,400 --> 02:02:05,520 WHAT'S REALLY -- HAPPEN TO BE 3208 02:02:05,520 --> 02:02:09,080 LISTED AS ONE OF OF THOSE THOSEE 3209 02:02:09,080 --> 02:02:10,080 THINK THAT'S ONE OF THE CLINICAL 3210 02:02:10,080 --> 02:02:13,600 TRIALS TO WAMP IN WATCH IN THER 3211 02:02:13,600 --> 02:02:13,880 2023. 3212 02:02:13,880 --> 02:02:16,040 THIS IS A STUDY DONE IN 3213 02:02:16,040 --> 02:02:17,960 SUB-SAHARAN AFRICA IN SEVEN 3214 02:02:17,960 --> 02:02:19,360 DIFFERENT COUNTRIES IN PEOPLE 3215 02:02:19,360 --> 02:02:22,680 WITH HIV W WHO ARE LARGELY 3216 02:02:22,680 --> 02:02:23,080 UNDERREPRESENTED. 3217 02:02:23,080 --> 02:02:24,800 IT'S THE LARGEST PHASE 3218 02:02:24,800 --> 02:02:26,440 3 EFFICACY TRIAL USING MRNA 3219 02:02:26,440 --> 02:02:26,800 VACCINES. 3220 02:02:26,800 --> 02:02:29,160 WE ARE LOOKING AT THESE AS 3221 02:02:29,160 --> 02:02:30,880 IMMUNOCOMPROMISED PEOPLE WHO 3222 02:02:30,880 --> 02:02:32,280 KNEED THEIR PRIMARY SERIES TO BE 3223 02:02:32,280 --> 02:02:34,600 AT A HIGHER DOSE, 3224 02:02:34,600 --> 02:02:36,640 100-MICROGRAMS, LOOKING AT TWO 3225 02:02:36,640 --> 02:02:41,920 DOSE VERSUS THREE DOSE RE 3226 02:02:41,920 --> 02:02:43,120 REGIMEN -- WHETHER THEY WERE 3227 02:02:43,120 --> 02:02:44,920 NAIVE OR PRIOR INFECTION AND WE 3228 02:02:44,920 --> 02:02:46,040 COULD LOOK AT THE IMPACT OF 3229 02:02:46,040 --> 02:02:47,440 HYBRID IMMUNITY IN THIS 3230 02:02:47,440 --> 02:02:47,760 POPULATION. 3231 02:02:47,760 --> 02:02:49,280 IMPORTANTLY WE'RE LOOKING FOR 3232 02:02:49,280 --> 02:02:50,040 PERSISTENT VIRAL SHEDDERS TO SEE 3233 02:02:50,040 --> 02:02:51,040 IF THERE WERE MUTATIONS 3234 02:02:51,040 --> 02:02:52,000 HAPPENING IN THESE INDIVIDUALS 3235 02:02:52,000 --> 02:02:55,360 TO SEE HOW THEY COULD INFORM 3236 02:02:55,360 --> 02:02:57,120 NEXT STEPS AND THEN WE WERE 3237 02:02:57,120 --> 02:02:58,560 LUCKY ENOUGH TO BE ABLE TO GET 3238 02:02:58,560 --> 02:03:03,400 ACCESS TO THE BIVALENT 3239 02:03:03,400 --> 02:03:04,200 BA.4/5 BOOSTER SO WE WERE ABLE 3240 02:03:04,200 --> 02:03:07,080 TO COMPARE THE MONOVALENT, THE 3241 02:03:07,080 --> 02:03:08,520 ORIGINAL MODERNA VACCINE WITH 3242 02:03:08,520 --> 02:03:09,200 THE BIVALENT. 3243 02:03:09,200 --> 02:03:10,840 SO I HOPE TO UPDATE THE COUNCIL 3244 02:03:10,840 --> 02:03:11,800 NEXT ON THE RESULTS OF THIS 3245 02:03:11,800 --> 02:03:15,240 STUDY. 3246 02:03:15,240 --> 02:03:17,160 HERE I'LL TALK ABOUT OUR HIV 3247 02:03:17,160 --> 02:03:18,320 VACCINE STRATEGY WHICH REALLY 3248 02:03:18,320 --> 02:03:24,520 FOCUSES ON DISCOVERY -- ANIMAL 3249 02:03:24,520 --> 02:03:24,880 WORK. 3250 02:03:24,880 --> 02:03:26,520 FIRST I'LL GIVE YOU -- THIS IS A 3251 02:03:26,520 --> 02:03:31,120 SLIDE YOU'VE SEEN MANY TIMES 3252 02:03:31,120 --> 02:03:32,360 BEFORE -- THE NIH VACCINE 3253 02:03:32,360 --> 02:03:32,640 STRATEGY. 3254 02:03:32,640 --> 02:03:34,240 WE HAD AN EMPIRICAL APPROACH AND 3255 02:03:34,240 --> 02:03:39,320 THERE ARE MANY STUDIES LIKE THE 3256 02:03:39,320 --> 02:03:41,080 702, 705 AND MOST RECENTLY NOW 3257 02:03:41,080 --> 02:03:46,120 THE MOSAICA STOPPED FOR 3258 02:03:46,120 --> 02:03:47,440 NON-EFFICACY -- INTO OUR 3259 02:03:47,440 --> 02:03:48,920 EFFICACY. 3260 02:03:48,920 --> 02:03:51,240 IT'S REALLY DISAPPOINTING FOR 3261 02:03:51,240 --> 02:03:54,520 THAT MOSAICO RESULT AND IT'S 3262 02:03:54,520 --> 02:03:58,720 ALSO SHOWING JUST UNACCEPTABLY 3263 02:03:58,720 --> 02:04:00,360 HIGH INCIDENCE LEVELS IN ANOTHER 3264 02:04:00,360 --> 02:04:03,240 HIGH RISK POPULATION. 3265 02:04:03,240 --> 02:04:04,760 WE CONTINUE IN PARALLEL, OF 3266 02:04:04,760 --> 02:04:06,360 COURSE, TO HAVE OTHER APPROACHES 3267 02:04:06,360 --> 02:04:07,360 FOR VACCINE DEVELOPMENT AND KNOW 3268 02:04:07,360 --> 02:04:09,360 THAT WE'RE GOING TO NEED ALL 3269 02:04:09,360 --> 02:04:09,840 HANDS ON DECK. 3270 02:04:09,840 --> 02:04:14,200 WE'RE GOING TO NEED UPTAKE OF 3271 02:04:14,200 --> 02:04:15,200 OTHER PREVENTIVE MEASURES AND 3272 02:04:15,200 --> 02:04:17,680 WE'RE GOING TO NEED NEUTRALIZING 3273 02:04:17,680 --> 02:04:19,000 ANTIBODIES AND CELLULAR IMMUNE 3274 02:04:19,000 --> 02:04:20,280 RESPONSES TO HELP US GET A GRIP 3275 02:04:20,280 --> 02:04:23,360 ON THIS PANDEMIC. 3276 02:04:23,360 --> 02:04:25,400 WHAT I'LL TALK ABOUT TODAY ARE 3277 02:04:25,400 --> 02:04:27,280 BASICALLY VACCINES TO ELICIT 3278 02:04:27,280 --> 02:04:30,320 BNABs SO THE ACTIVE APPROACH 3279 02:04:30,320 --> 02:04:31,120 FOR PREVENTION AND THEN I'LL 3280 02:04:31,120 --> 02:04:33,800 TALK A LITTLE BIT ABOUT PASSIVE 3281 02:04:33,800 --> 02:04:36,120 IMMUNOPROPHYLAXIS WITH BNABs. 3282 02:04:36,120 --> 02:04:38,720 BNABs ARE REALLY SORT OF A 3283 02:04:38,720 --> 02:04:40,440 CRITICAL COB IN VACCINE 3284 02:04:40,440 --> 02:04:42,560 DEVELOPMENT BECAUSE THEY HELP US 3285 02:04:42,560 --> 02:04:49,320 DESIGN THE IMMUNOGENS. 3286 02:04:49,320 --> 02:04:50,480 SO JUST TO FRAME THE DISCUSSION 3287 02:04:50,480 --> 02:04:54,680 IN THE CASE FOR BNABs, THERE 3288 02:04:54,680 --> 02:04:56,920 IS A GROWING BODY OF DAY THAT 3289 02:04:56,920 --> 02:05:00,200 SUPPORTS THE GROWING FEASIBILITY 3290 02:05:00,200 --> 02:05:02,080 OF -- THEY DEVELOP IN ABOUT 20% 3291 02:05:02,080 --> 02:05:08,600 OF PEOPLE WITH HIV -- HIGHLY 3292 02:05:08,600 --> 02:05:10,360 SPECIALIZED ALBEIT SLOWLY 3293 02:05:10,360 --> 02:05:15,040 DEVELOPED ANTIBODY. 3294 02:05:15,040 --> 02:05:16,400 THERE ARE MULTIPLE 3295 02:05:16,400 --> 02:05:17,640 NEUTRALIZATION TARGETS SO 3296 02:05:17,640 --> 02:05:19,320 THERE'S MULTIPLE SITES OF 3297 02:05:19,320 --> 02:05:20,080 WEAKNESS ON THE ENVELOPE AND 3298 02:05:20,080 --> 02:05:21,840 THAT'S WHERE THESE BNABs ARE 3299 02:05:21,840 --> 02:05:24,440 DIRECTED. 3300 02:05:24,440 --> 02:05:26,680 THE ENVELOPE CO-EVOLUTION 3301 02:05:26,680 --> 02:05:28,240 PROCESS BEING DEVELOPED IN 3302 02:05:28,240 --> 02:05:30,760 HUMANS IS FAITHFULLY 3303 02:05:30,760 --> 02:05:32,120 RECAPITULATED IN THE NON-HUMAN 3304 02:05:32,120 --> 02:05:35,200 PRIMATE MODEL, WHICH IS AN 3305 02:05:35,200 --> 02:05:37,920 EXCELLENT SOURCE -- LABORATORY. 3306 02:05:37,920 --> 02:05:42,160 WE KNOW FOR DECADES NOW THAT B 3307 02:05:42,160 --> 02:05:43,600 BNABs PREVENT INFECTION IN 3308 02:05:43,600 --> 02:05:44,760 NON-HUMAN PRIMARY CHALLENGE 3309 02:05:44,760 --> 02:05:45,160 MODEL. 3310 02:05:45,160 --> 02:05:46,440 BUT ONLY RECENTLY DID WE LEARN 3311 02:05:46,440 --> 02:05:49,680 THAT BNABs, AT LEAST THE -- 3312 02:05:49,680 --> 02:05:52,200 CAN PREVENT HIV INFECTION IN 3313 02:05:52,200 --> 02:05:56,240 HUMANS WHEN WE CONDUCTED THE 3314 02:05:56,240 --> 02:05:56,800 ANTIBODY-MEDIATED PROTECTION 3315 02:05:56,800 --> 02:05:57,000 STUDY. 3316 02:05:57,000 --> 02:05:58,240 WHAT WE LEARNED THERE WAS THAT 3317 02:05:58,240 --> 02:05:59,520 THE ANTIBODIES IN HIGH ENOUGH 3318 02:05:59,520 --> 02:06:01,680 LEVEL AND THE INCOMING VIRUS IS 3319 02:06:01,680 --> 02:06:06,480 SENSITIVE THAT WE CAN ACTUALLY 3320 02:06:06,480 --> 02:06:07,800 MITIGATE ACQUISITION. 3321 02:06:07,800 --> 02:06:11,080 NOW ONE OF THE MORE -- MOST 3322 02:06:11,080 --> 02:06:12,720 EXCITING RECENT FINDINGS IS THAT 3323 02:06:12,720 --> 02:06:15,360 WE ARE LEARNING HOW TO IN A 3324 02:06:15,360 --> 02:06:17,160 PREDICTABLE WAY STIMULATE THE 3325 02:06:17,160 --> 02:06:19,560 HUMAN IMMUNE RESPONSE TO 3326 02:06:19,560 --> 02:06:21,360 ACTIVATE HIV BROADLY 3327 02:06:21,360 --> 02:06:23,400 NEUTRALIZING AND BODY PRECURSORS 3328 02:06:23,400 --> 02:06:26,920 THROUGH GERMLINE AND TARGETING 3329 02:06:26,920 --> 02:06:27,600 VACCINATION. 3330 02:06:27,600 --> 02:06:28,640 ONE BIG OPEN REMAINING QUESTION 3331 02:06:28,640 --> 02:06:31,600 TO BE INTELLECTUALLY HONEST AND 3332 02:06:31,600 --> 02:06:32,880 TECHNICALLY HONEST IS THAT WE 3333 02:06:32,880 --> 02:06:36,920 DON'T KNOW WHETHER THE VACCINES 3334 02:06:36,920 --> 02:06:38,360 CAN DRIVE BROAD NEUTRALIZING 3335 02:06:38,360 --> 02:06:40,520 ANTIBODIES IN HIGH ENOUGH TITERS 3336 02:06:40,520 --> 02:06:41,960 TO PROTECT SO WE HAVE TO RELY ON 3337 02:06:41,960 --> 02:06:43,320 OTHER PARTS OF THE IMMUNE SYSTEM 3338 02:06:43,320 --> 02:06:46,320 AS I SAID BEFORE. 3339 02:06:46,320 --> 02:06:48,800 THIS IS AN OVERVIEW OF WHAT WE 3340 02:06:48,800 --> 02:06:51,680 USE CALLED ANTIBODY BASE VACCINE 3341 02:06:51,680 --> 02:06:52,120 DESIGN. 3342 02:06:52,120 --> 02:06:57,400 SO WE START WITH AN ANTIBODY 3343 02:06:57,400 --> 02:06:58,400 NEUTRALIZING -- SAY FOR EXAMPLE 3344 02:06:58,400 --> 02:07:02,320 THE CD4 BINDING SITE OR THE 3345 02:07:02,320 --> 02:07:05,040 B3 SUPER SITE. 3346 02:07:05,040 --> 02:07:06,920 WE IDENTIFY THE VIRAL EPITOPE 3347 02:07:06,920 --> 02:07:09,480 THAT'S TARGETED BY THAT SPACING 3348 02:07:09,480 --> 02:07:12,040 AT THE ATOMIC LEVEL AND THEN USE 3349 02:07:12,040 --> 02:07:13,240 THIS DESIGN APPROACH TO MODEL 3350 02:07:13,240 --> 02:07:16,400 OUR VACCINE. 3351 02:07:16,400 --> 02:07:17,840 THAT VACCINE SHOULD SIMILARLY 3352 02:07:17,840 --> 02:07:19,920 ELICIT A NEUTRALIZING AN BODY. 3353 02:07:19,920 --> 02:07:22,280 NOW, THE ISSUE WITH THESE 3354 02:07:22,280 --> 02:07:24,760 IMMUNOGENS THAT ARE DESIGNED -- 3355 02:07:24,760 --> 02:07:27,360 THERE ARE DEFINITELY -- THEY 3356 02:07:27,360 --> 02:07:32,560 TEND TO BE SUBDOMINANT ON THE 3357 02:07:32,560 --> 02:07:33,600 TRIMERIC SPIKE, AND THEY ARE 3358 02:07:33,600 --> 02:07:36,400 HARD TO ACCESS. 3359 02:07:36,400 --> 02:07:37,880 THERE'S GLYCAN COVERAGE AS YOU 3360 02:07:37,880 --> 02:07:39,560 KNOW SO IT'S NOT EXACTLY 3361 02:07:39,560 --> 02:07:41,280 STRAIGHTFORWARD BUT I'D LOVE TO 3362 02:07:41,280 --> 02:07:43,240 SHOW YOU SOME PROGRESS WE HAVE 3363 02:07:43,240 --> 02:07:44,440 IN THIS AREA. 3364 02:07:44,440 --> 02:07:47,160 WE NOW KNOW WE NEED TO TARGET 3365 02:07:47,160 --> 02:07:48,120 GERMLINE. 3366 02:07:48,120 --> 02:07:51,960 SO THIS IS JUST A GRAPHIC THAT 3367 02:07:51,960 --> 02:07:55,600 SHOWS HOW WE WOULD INDUCE THESE 3368 02:07:55,600 --> 02:07:56,560 BNABs AT VACCINATION, AGAIN 3369 02:07:56,560 --> 02:07:58,400 YOU SEE THE MULTIPLE SITES OF 3370 02:07:58,400 --> 02:07:58,800 VULNERABILITY. 3371 02:07:58,800 --> 02:08:00,160 WE USE MULTIPLE DIFFERENT 3372 02:08:00,160 --> 02:08:01,560 BNABs THAT ARE LISTED BELOW 3373 02:08:01,560 --> 02:08:06,200 THOSE SITES TO DEVELOP OUR IMAGE 3374 02:08:06,200 --> 02:08:07,440 AND DESIGN AS BNAB TARGETS. 3375 02:08:07,440 --> 02:08:08,840 WE PRIME THE IMMUNE SYSTEM 3376 02:08:08,840 --> 02:08:10,400 TARGETING NAIVE B CELLS. 3377 02:08:10,400 --> 02:08:12,640 THOSE NAIVE B CELLS HAD TO GO TO 3378 02:08:12,640 --> 02:08:15,200 THE GYM, WHERE THEY WORK OUT AND 3379 02:08:15,200 --> 02:08:16,840 THE LONGER THEY'RE IN THE GYM, 3380 02:08:16,840 --> 02:08:18,120 THE BETTER THEY BECOME. 3381 02:08:18,120 --> 02:08:24,240 THEY NEED TO RECYCLE THROUGH THE 3382 02:08:24,240 --> 02:08:27,280 JENSEN TER, THEY NEED T 3383 02:08:27,280 --> 02:08:29,560 FOLLICULAR HELP AND THROUGH 3384 02:08:29,560 --> 02:08:30,200 SEQUENTIAL IMMUNIZATION WE THINK 3385 02:08:30,200 --> 02:08:33,960 WE CAN BOOST THESE INTO MATURE B 3386 02:08:33,960 --> 02:08:36,760 CELLS THAT CAN ELICIT BNABS. 3387 02:08:36,760 --> 02:08:38,400 SO BOTTOM LINE IS THE OBJECTIVE 3388 02:08:38,400 --> 02:08:43,960 TO DRIVE B CELLS -- WE KNOW 3389 02:08:43,960 --> 02:08:44,960 PRECURSORS ARE RARE, THEY'RE 3390 02:08:44,960 --> 02:08:45,960 DIVERSE AND DIFFICULT TO 3391 02:08:45,960 --> 02:08:47,040 ACTIVATE WITH HIV PROTEINS. 3392 02:08:47,040 --> 02:08:48,440 SO WHAT THE INVESTIGATORS HAD TO 3393 02:08:48,440 --> 02:08:51,840 DO IS DEVELOP THESE SPECIALIZED 3394 02:08:51,840 --> 02:08:54,240 GENERAL TARGETING IMMUNOGENS 3395 02:08:54,240 --> 02:08:55,680 WITH OPTIMAL AFFINITY THAT CAN 3396 02:08:55,680 --> 02:08:57,520 BROADLY TARGET A DIVERSE 3397 02:08:57,520 --> 02:08:59,320 PRECURSOR POOL OF B CELLS WITHIN 3398 02:08:59,320 --> 02:09:02,840 A BNAB CLASS. 3399 02:09:02,840 --> 02:09:06,360 I CAN SHOW YOU MORE DETAIL ON 3400 02:09:06,360 --> 02:09:07,640 THIS STRATEGY. 3401 02:09:07,640 --> 02:09:09,520 WE THINK WE NEED SEQUENTIAL 3402 02:09:09,520 --> 02:09:10,600 IMMUNIZATION TO INDUCE THESE 3403 02:09:10,600 --> 02:09:11,000 BNABs. 3404 02:09:11,000 --> 02:09:12,560 SO IF YOU LOOK ON THE FAR LEFT, 3405 02:09:12,560 --> 02:09:15,160 THE VACCINE PRIME WITH GERMLINE 3406 02:09:15,160 --> 02:09:16,120 TARGETING, WE'D ACTUALLY 3407 02:09:16,120 --> 02:09:18,000 ACCOMPLISH THAT STEP. 3408 02:09:18,000 --> 02:09:21,840 THIS WAS DONE IN THE PHASE ONE 3409 02:09:21,840 --> 02:09:23,120 G001 STUDY THAT WAS PUBLISHED 3410 02:09:23,120 --> 02:09:24,960 THIS YEAR AND I'LL TALK ABOUT 3411 02:09:24,960 --> 02:09:26,160 THAT IN DETAIL IN THE NEXT 3412 02:09:26,160 --> 02:09:26,960 SLIDE. 3413 02:09:26,960 --> 02:09:28,320 BUT SINCE WE'VE ACCOMPLISHED 3414 02:09:28,320 --> 02:09:29,520 THAT FIRST STEP, NOW WE'RE GOING 3415 02:09:29,520 --> 02:09:33,760 TO BE MOVING INTO BOOSTING. 3416 02:09:33,760 --> 02:09:40,880 SO HERE'S THE -- GIVEN THE 3417 02:09:40,880 --> 02:09:41,920 SIGNIFICANCE OF IT I WANTED TO 3418 02:09:41,920 --> 02:09:44,600 REVIEW SOME OF THE DATA. 3419 02:09:44,600 --> 02:09:48,440 THIS IS A SELF ASSEMBLING 3420 02:09:48,440 --> 02:09:52,040 NANOPARTICLE, USED WITH A STRONG 3421 02:09:52,040 --> 02:09:55,960 EDGE -- MANY ARE FAMILIAR HOW -- 3422 02:09:55,960 --> 02:09:56,280 ADJUVANT IS. 3423 02:09:56,280 --> 02:09:59,280 THE STUDY WAS SUCCESSFUL IN THAT 3424 02:09:59,280 --> 02:10:02,520 97% OF PARTICIPANTS DEVELOPED 3425 02:10:02,520 --> 02:10:05,600 VRC-OH 1 CLASS IGG POSITIVE B 3426 02:10:05,600 --> 02:10:06,920 CELLS AND THEY WERE IN HIGH 3427 02:10:06,920 --> 02:10:11,880 ENOUGH FREAK SE FREQUENCY TO COR 3428 02:10:11,880 --> 02:10:12,320 BOOSTING. 3429 02:10:12,320 --> 02:10:17,360 DOSE BNAB RESPONSES WERE 3430 02:10:17,360 --> 02:10:20,320 ELICITED AT HIGH AFFINITIES TO 3431 02:10:20,320 --> 02:10:23,800 THE -- AND THEY INCREASED OVER 3432 02:10:23,800 --> 02:10:24,440 TIME. 3433 02:10:24,440 --> 02:10:25,240 SO WE THINK THE SIGNIFICANCE OF 3434 02:10:25,240 --> 02:10:28,560 THE STUDY IS IT VALIDATED THE 3435 02:10:28,560 --> 02:10:30,440 GERMLINE TARGETING CONCEPT AND 3436 02:10:30,440 --> 02:10:35,320 SERVES AS A CANDIDATE TO PRIME 3437 02:10:35,320 --> 02:10:40,680 BVRC018 ANTIBODIES. 3438 02:10:40,680 --> 02:10:42,320 PROVIDES KEY REAGENT FOR US TO 3439 02:10:42,320 --> 02:10:45,600 STUDY THIS PROCESS MOVING 3440 02:10:45,600 --> 02:10:46,480 FORWARD. 3441 02:10:46,480 --> 02:10:49,000 THE NEXT STEPS OF COURSE ARE TO 3442 02:10:49,000 --> 02:10:51,280 USE MRNA DELIVERY ALONG WITH A 3443 02:10:51,280 --> 02:10:54,680 CORE BOOST, AGAIN, MRNA DELIVERY 3444 02:10:54,680 --> 02:10:59,760 TO ACCELERATE. 3445 02:10:59,760 --> 02:11:01,000 JUST LIKE TO REMIND YOU THAT 3446 02:11:01,000 --> 02:11:03,680 WE'VE COME A LONG WAY WITH 3447 02:11:03,680 --> 02:11:07,680 MRNAs, NOT ONLY ARE EXCELLENT 3448 02:11:07,680 --> 02:11:08,440 PROTEIN PROTEIN PRODUCTION 3449 02:11:08,440 --> 02:11:13,040 FACILITY, THEY CAN ENCODE VERY 3450 02:11:13,040 --> 02:11:14,320 COMPLEX HIV IMMUNOGENS THAT ARE 3451 02:11:14,320 --> 02:11:15,760 GOING TO BE NEEDED FOR HIV 3452 02:11:15,760 --> 02:11:16,080 VACCINE. 3453 02:11:16,080 --> 02:11:19,280 THIS STUDY THAT COMES OUT OF -- 3454 02:11:19,280 --> 02:11:21,120 SHOWS HIV EXPRESSED ENVELOPE 3455 02:11:21,120 --> 02:11:23,400 NANOPARTICLES ARE WELL FOLDED 3456 02:11:23,400 --> 02:11:26,560 WITH OPTIMIZED MUTATIONS. 3457 02:11:26,560 --> 02:11:33,800 THEY ARE STABLY EXPRESSED AND SO 3458 02:11:33,800 --> 02:11:35,080 PREFERENTIAL B CELL BINDING AND 3459 02:11:35,080 --> 02:11:36,600 IN AN ANIMAL MOUSE MODEL, THEY 3460 02:11:36,600 --> 02:11:39,040 SHOWED THAT THEY COULD ELICIT 3461 02:11:39,040 --> 02:11:41,400 AUTOLOGOUS TIER 2 NEUTRALIZING 3462 02:11:41,400 --> 02:11:43,920 ANTIBODIES WITH IMPORTANT BNAB 3463 02:11:43,920 --> 02:11:45,440 MUTATIONS THAT WE THINK IS A 3464 02:11:45,440 --> 02:11:50,360 VERY PROMISING ANIMAL MODEL AND 3465 02:11:50,360 --> 02:11:55,080 MAY PREDICT WHAT WE CAN SEE IN 3466 02:11:55,080 --> 02:11:55,400 HUMANS. 3467 02:11:55,400 --> 02:11:57,200 HERE IS WHERE I'M GOING TO 3468 02:11:57,200 --> 02:11:58,400 PROCEED WITH SEVERAL NON-HUMAN 3469 02:11:58,400 --> 02:12:00,080 PRIMATE STUDIES, SOME OF WHICH 3470 02:12:00,080 --> 02:12:06,560 YOU'LL BE FAMILIAR WITH. 3471 02:12:06,560 --> 02:12:08,480 THIS PAPER WAS PUBLISHED IN 3472 02:12:08,480 --> 02:12:11,560 NOVEMBER 2022 IN NATURE, OR 3473 02:12:11,560 --> 02:12:12,720 SEPTEMBER, I THINK, 2022. 3474 02:12:12,720 --> 02:12:15,520 IT MIGHT BE FAMILIAR BECAUSE I 3475 02:12:15,520 --> 02:12:17,320 REVIEWED IT LAST YEAR PRIOR TO 3476 02:12:17,320 --> 02:12:18,880 PUBLICATION, BUT IT'S SO ELEGANT 3477 02:12:18,880 --> 02:12:23,160 AND IT'S SO SIMPLE, I THINK IT 3478 02:12:23,160 --> 02:12:24,640 REALLY BEARS REPEATING AND 3479 02:12:24,640 --> 02:12:25,640 EMPHASIZING SOME OF THE 3480 02:12:25,640 --> 02:12:26,520 FINDINGS. 3481 02:12:26,520 --> 02:12:29,280 WHAT THEY DID WAS THEY JUST 3482 02:12:29,280 --> 02:12:30,800 TOOK -- COMPARED THE BOLUS 3483 02:12:30,800 --> 02:12:32,720 INJECTION OF AN IMMUNOGEN, 3484 02:12:32,720 --> 02:12:35,040 WHAT'S CALLED AN MD30.3, WHICH 3485 02:12:35,040 --> 02:12:39,000 IS A TRIMER PROTEIN, AND WAS 3486 02:12:39,000 --> 02:12:40,640 ADJUVANTED WITH A POTENT 3487 02:12:40,640 --> 02:12:42,040 ADJUVANT AND THEY COMPARED A 3488 02:12:42,040 --> 02:12:43,440 BOLUS SINGLE INJECTION VERSUS 3489 02:12:43,440 --> 02:12:46,960 GIVING SMALLER DOSES EVERY OTHER 3490 02:12:46,960 --> 02:12:49,120 DAY OVER A 12-DAY PERIOD WHICH 3491 02:12:49,120 --> 02:12:50,920 THEY CALL SLOW PRIMING WHA. THEY 3492 02:12:50,920 --> 02:12:52,440 FOUND WAS THERE WERE DRAMATIC 3493 02:12:52,440 --> 02:12:53,720 INCREASES IN THE LENGTH OF THESE 3494 02:12:53,720 --> 02:12:54,760 GERMINAL CENTER RESPONSES. 3495 02:12:54,760 --> 02:12:56,640 THEY SEEMED TO BE PROLONGED OVER 3496 02:12:56,640 --> 02:13:05,080 A SIX-MONTH PEERPD, THERE WAS 3497 02:13:05,080 --> 02:13:07,560 CONTINUOUS GERM CELL ACTIVITY, 3498 02:13:07,560 --> 02:13:09,560 AND IMPORTANTLY AS BOXED IN THE 3499 02:13:09,560 --> 02:13:11,920 MID EVIDENTLY THIS SLIDE, YOU 3500 02:13:11,920 --> 02:13:20,680 SEE THERE'S -- THERE WAS TIER 3501 02:13:20,680 --> 02:13:21,320 2 NEUTRALIZATION -- WHICH HAS 3502 02:13:21,320 --> 02:13:24,080 REALLY BEEN A BIG, BIG STEP WE 3503 02:13:24,080 --> 02:13:25,560 NEEDED TO SEE IN OUR ANIMAL 3504 02:13:25,560 --> 02:13:25,800 MODEL. 3505 02:13:25,800 --> 02:13:27,240 THE LAST THING I WANTED TO 3506 02:13:27,240 --> 02:13:30,280 MENTION WAS THAT THROUGH THE 3507 02:13:30,280 --> 02:13:37,840 POWER OF CRYO-EM -- A WAY TO 3508 02:13:37,840 --> 02:13:39,000 CHARACTERIZE B CELL RESPONSES, 3509 02:13:39,000 --> 02:13:40,120 YOU CAN SEE ON THE LEFT THEY 3510 02:13:40,120 --> 02:13:41,760 SHOW ACTUALLY ON THE -- WHERE 3511 02:13:41,760 --> 02:13:43,280 THESE BARRIERS TO ANTIBODY 3512 02:13:43,280 --> 02:13:44,320 RESPONSES ARE BINDING, AND YOU 3513 02:13:44,320 --> 02:13:45,440 CAN TELL THAT THEY'RE HITTING A 3514 02:13:45,440 --> 02:13:47,240 LOT OF DIFFERENT EPITOPES. 3515 02:13:47,240 --> 02:13:48,760 THEY'RE HITTING THE B1, YOU 3516 02:13:48,760 --> 02:13:50,680 KNOW, THEY'RE HITTING THE -- 3517 02:13:50,680 --> 02:13:54,400 THEY'RE HITTING VARIOUS SITES 3518 02:13:54,400 --> 02:13:57,080 AND THAT SHOWS US THAT WITH THE 3519 02:13:57,080 --> 02:14:00,320 RIGHT DELIVERY AND WITH THE 3520 02:14:00,320 --> 02:14:01,880 RIGHT ADJUVANT, WE CAN 3521 02:14:01,880 --> 02:14:03,400 AFFINITY-MATURE THE ANTIBODY 3522 02:14:03,400 --> 02:14:04,960 RESPONSE AND GET BREADTH AND 3523 02:14:04,960 --> 02:14:08,440 INCREASED PROPENSITY. 3524 02:14:08,440 --> 02:14:08,760 OKAY. 3525 02:14:08,760 --> 02:14:14,800 NEXT SLIDE. 3526 02:14:14,800 --> 02:14:16,640 THIS IS JUST REINFORCING THE 3527 02:14:16,640 --> 02:14:18,480 IDEA THAT AGAIN IN THE NON-HUMAN 3528 02:14:18,480 --> 02:14:20,840 PRIMATE MODEL, WE CAN TAKE 3529 02:14:20,840 --> 02:14:22,560 ANOTHER TRIMER THAT WAS 3530 02:14:22,560 --> 02:14:29,320 FORMULATED WITH A POTENT 3531 02:14:29,320 --> 02:14:32,520 ADJUVANT 30152 -- PROTECTION 3532 02:14:32,520 --> 02:14:34,200 TO --. 3533 02:14:34,200 --> 02:14:37,360 THIS IS WHERE I'M GOING TO MOVE 3534 02:14:37,360 --> 02:14:41,280 NOW FROM THE ANTIBODY BASE OF 3535 02:14:41,280 --> 02:14:42,960 VACCINES TO -- WHICH MANY OF YOU 3536 02:14:42,960 --> 02:14:47,560 ARE FAMILIAR WITH THE LEWIS -- 3537 02:14:47,560 --> 02:14:50,440 THAT HAS BEEN SHOWN THROUGH THE 3538 02:14:50,440 --> 02:14:53,120 INDUCTION OF VERY SPECIALIZED 3539 02:14:53,120 --> 02:14:56,080 T-CELLS THAT ARE PRIMED WITH THE 3540 02:14:56,080 --> 02:14:58,560 CMV VACCINE THAT CAN CONTROL SIV 3541 02:14:58,560 --> 02:15:00,080 REPLICATION AND IS SAID TO CLEAR 3542 02:15:00,080 --> 02:15:01,680 INFECTION IN ABOUT 50 TO 60% OF 3543 02:15:01,680 --> 02:15:02,680 THE ANIMALS. 3544 02:15:02,680 --> 02:15:05,720 THIS HAS BEEN REPEATED IN OVER 3545 02:15:05,720 --> 02:15:06,160 200 ANIMALS. 3546 02:15:06,160 --> 02:15:08,920 IT'S BEEN SHOWN NOW, THE 3547 02:15:08,920 --> 02:15:10,400 IMPORTANCE OF THIS STUDY, THAT 3548 02:15:10,400 --> 02:15:13,280 THEY CAN SHOW IT IN NOT ONLY THE 3549 02:15:13,280 --> 02:15:15,800 RHESUS MACAQUE BUT ALSO IN THE 3550 02:15:15,800 --> 02:15:18,520 SIN MOL GUS SPECIES. 3551 02:15:18,520 --> 02:15:20,480 THIS IS IMPORTANT BECAUSE CMV IS 3552 02:15:20,480 --> 02:15:21,760 VERY SPECIES-SPECIFIC AND IT 3553 02:15:21,760 --> 02:15:22,600 WASN'T CLEAR IF THIS WAS GOING 3554 02:15:22,600 --> 02:15:26,640 TO BE A ONE OFF IN RHESUS BUT 3555 02:15:26,640 --> 02:15:27,440 NOW WHAT THEY'VE SHOWN IS AS 3556 02:15:27,440 --> 02:15:37,960 LONG AS THE VECTOR MATCHES THE 3557 02:15:39,560 --> 02:15:42,760 CYNOS, IT WILL INDUCE THE SAME 3558 02:15:42,760 --> 02:15:46,960 RESPONSE -- IT ELICITS THE SAME 3559 02:15:46,960 --> 02:15:47,920 PROTECTION AND ALSO THE SAME 3560 02:15:47,920 --> 02:15:51,640 SIGNATURE THAT'S ASSOCIATED WITH 3561 02:15:51,640 --> 02:15:52,200 PROTECTION. 3562 02:15:52,200 --> 02:15:54,720 SO THIS IS REALLY IMPORTANT 3563 02:15:54,720 --> 02:15:57,680 BECAUSE IT'S POSSIBLE THAT -- IF 3564 02:15:57,680 --> 02:16:02,800 WE USE THE HUMAN [INAUDIBLE]. 3565 02:16:02,800 --> 02:16:05,960 ON THIS SAME VECTOR, THE SAME 3566 02:16:05,960 --> 02:16:09,240 CMV VECTOR, WE'VE FOCUSED ON 3567 02:16:09,240 --> 02:16:12,080 THESE RESTRICTED T-CELLS BECAUSE 3568 02:16:12,080 --> 02:16:13,280 WE SUSPECTED THEY WERE 3569 02:16:13,280 --> 02:16:14,360 RESPONSIBLE FOR PROTECTION AND 3570 02:16:14,360 --> 02:16:16,000 WE FOUND OUT INTERESTINGLY 3571 02:16:16,000 --> 02:16:17,400 ENOUGH THAT THEY HAVE MYELOID 3572 02:16:17,400 --> 02:16:18,400 CELL TROPISM. 3573 02:16:18,400 --> 02:16:19,520 THEY TARGET THE MYELOID CELLS 3574 02:16:19,520 --> 02:16:22,360 AND THAT ENABLES THEM TO INDUCE 3575 02:16:22,360 --> 02:16:25,200 THESE MHC RESTRICTED T-CELLS 3576 02:16:25,200 --> 02:16:27,400 THAT CAN CONSTRAIN SIV 3577 02:16:27,400 --> 02:16:28,440 REPLICATION SO THE KEY FINDING 3578 02:16:28,440 --> 02:16:29,480 HERE IS THAT ONLY VECTORS THAT 3579 02:16:29,480 --> 02:16:32,840 ARE PROGRAMMED TO ELICIT THESE 3580 02:16:32,840 --> 02:16:39,080 MHC-E RESTRICTED CD8 T-CELLS CAN 3581 02:16:39,080 --> 02:16:40,160 PROTECT AGAINST -- TRANSMISSION 3582 02:16:40,160 --> 02:16:49,240 TO THE HUMAN HIV MODEL. 3583 02:16:49,240 --> 02:16:51,200 THIS COULD BE FAMILIAR TOO 3584 02:16:51,200 --> 02:16:52,160 BECAUSE I PRESENTED IT LAST 3585 02:16:52,160 --> 02:16:54,240 TIME. 3586 02:16:54,240 --> 02:16:55,400 THANKS SO MUCH FOR THAT, KEN. 3587 02:16:55,400 --> 02:16:56,440 I REALLY APPRECIATE THIS. 3588 02:16:56,440 --> 02:16:58,720 THIS IS BASICALLY A STUDY THAT 3589 02:16:58,720 --> 02:16:59,800 WILL LOOK FOR THE 3590 02:16:59,800 --> 02:17:00,720 REPRODUCIBILITY OF AN IMPORTANT 3591 02:17:00,720 --> 02:17:02,200 STUDY THAT CAME OUT OF EMORY IN 3592 02:17:02,200 --> 02:17:07,600 2020 THAT SHOWED THAT IF YOU USE 3593 02:17:07,600 --> 02:17:09,680 TRIMERIC PROTEIN ALONE OR WITH 3594 02:17:09,680 --> 02:17:11,080 VARIOUS VIRAL VECTORS, YOU CAN 3595 02:17:11,080 --> 02:17:12,480 ACTUALLY INDUCE BOTH THE T-CELL 3596 02:17:12,480 --> 02:17:14,800 AND AN ANTIBODY RESPONSE. 3597 02:17:14,800 --> 02:17:16,320 IT TURNS OUT THE COMBINATION OF 3598 02:17:16,320 --> 02:17:17,160 THAT RESPONSE LOWERS THE 3599 02:17:17,160 --> 02:17:18,200 THRESHOLD OF THE ANTIBODY LEVELS 3600 02:17:18,200 --> 02:17:19,400 THAT ARE NEEDED FOR PROTECTION 3601 02:17:19,400 --> 02:17:20,920 AND IT ALSO INCREASES 3602 02:17:20,920 --> 02:17:21,240 DURABILITY. 3603 02:17:21,240 --> 02:17:22,480 THESE ARE VERY IMPORTANT 3604 02:17:22,480 --> 02:17:30,560 QUESTIONS FOR VACCINE DESIGN. 3605 02:17:30,560 --> 02:17:31,320 [INAUDIBLE]. 3606 02:17:31,320 --> 02:17:32,360 THANKS. 3607 02:17:32,360 --> 02:17:34,040 SO WE'RE FORTUNATE TO HAVE A 3608 02:17:34,040 --> 02:17:34,800 TRANSLATIONAL BRANCH THAT I TOLD 3609 02:17:34,800 --> 02:17:39,200 YOU IS FROM -- DOES MANY, MANY 3610 02:17:39,200 --> 02:17:41,640 THINGS IN ADDITION TO TMP 3611 02:17:41,640 --> 02:17:42,080 MANUFACTURING. 3612 02:17:42,080 --> 02:17:45,120 CAN YOU YOU CAN SEE ALL THE PROT 3613 02:17:45,120 --> 02:17:50,000 TYPES THEY WORK ON, VIRAL 3614 02:17:50,000 --> 02:17:50,360 VECTORS. 3615 02:17:50,360 --> 02:17:52,520 THE GOAL IS FOR THEM TO PRODUCE 3616 02:17:52,520 --> 02:17:55,480 THE BEST -- AND BE TRANSLATED 3617 02:17:55,480 --> 02:17:58,360 INTO CLINICAL TESTING THROUGH 3618 02:17:58,360 --> 02:17:58,960 PILOT -- PRODUCTION. 3619 02:17:58,960 --> 02:18:00,640 THIS IS A LIST OF ALL THE 3620 02:18:00,640 --> 02:18:03,920 ADJUVANTS THAT ARE NOW 3621 02:18:03,920 --> 02:18:04,800 AVAILABLE. 3622 02:18:04,800 --> 02:18:05,600 INVESTIGATORS FREQUENTLY HAVE 3623 02:18:05,600 --> 02:18:07,600 TROUBLE GETTING ACCESS TO 3624 02:18:07,600 --> 02:18:12,000 ADJUVANTS AND THIS MADE IT A 3625 02:18:12,000 --> 02:18:14,240 GOAL TO MAKE THESE EIGHT THAT 3626 02:18:14,240 --> 02:18:16,600 ARE PROMISING AND ON THE PATH TO 3627 02:18:16,600 --> 02:18:18,440 INVESTIGATORS. 3628 02:18:18,440 --> 02:18:21,480 SO CAN ONLY HIGHLIGHT FOUR HIV 3629 02:18:21,480 --> 02:18:22,920 VACCINE CLINICAL TRIALS. 3630 02:18:22,920 --> 02:18:25,080 THERE ARE MANY TRIALS GOING ON, 3631 02:18:25,080 --> 02:18:26,080 BUT IT'S IMPORTANT THAT YOU KNOW 3632 02:18:26,080 --> 02:18:30,000 THAT THERE ARE MULTIPLE RNA HIV 3633 02:18:30,000 --> 02:18:32,200 VACCINE -- IN CLINIC. 3634 02:18:32,200 --> 02:18:35,400 COMPARES MEMBRANE -- THIS WAS 3635 02:18:35,400 --> 02:18:36,600 THE SAME TRIMER THAT WAS REACHED 3636 02:18:36,600 --> 02:18:46,040 IN THAT PRIMATE STUDY. 3637 02:18:46,040 --> 02:18:50,680 THAT WILL NOW BE BOOSTED WITH AN 3638 02:18:50,680 --> 02:18:52,280 MRNA CORE IMMUNOGEN. 3639 02:18:52,280 --> 02:18:58,440 I WILL JUST GO OVER THERE REALLY 3640 02:18:58,440 --> 02:18:58,760 QUICKLY. 3641 02:18:58,760 --> 02:19:00,400 THERE ARE THREE PHASE ONE 3642 02:19:00,400 --> 02:19:02,480 STUDIES THAT CAN ELICIT 3643 02:19:02,480 --> 02:19:03,640 NEUTRALIZING ANTIBODIES. 3644 02:19:03,640 --> 02:19:05,680 SOME OF THESE ARE POLYCLONAL. 3645 02:19:05,680 --> 02:19:09,200 THEY USE PROTEINS WITH POTENT 3646 02:19:09,200 --> 02:19:12,240 ADJUVANTS LIKE 3M-052. 3647 02:19:12,240 --> 02:19:15,760 THEY INDUCE YOU A TOLL JUST TIER 3648 02:19:15,760 --> 02:19:16,280 2 NEUTRALIZING ANTIBODIES. 3649 02:19:16,280 --> 02:19:17,920 SPECIFICALLY WITH THAT ADJUVANT. 3650 02:19:17,920 --> 02:19:19,000 IT'S NOT SEEN WITH OTHER 3651 02:19:19,000 --> 02:19:20,440 ADJUVANTS JUST TO BRING THAT 3652 02:19:20,440 --> 02:19:20,800 OUT. 3653 02:19:20,800 --> 02:19:24,560 FINALLY WE SAW THIS WITH 3654 02:19:24,560 --> 02:19:25,880 HVTN300, AGAIN THAT SAME 3655 02:19:25,880 --> 02:19:26,880 ADJUVANT, AND FINALLY I WANTED 3656 02:19:26,880 --> 02:19:28,280 TO JUST BRING TO YOUR ATTENTION 3657 02:19:28,280 --> 02:19:32,560 THE HVTN133, WHICH IS AN MPER 3658 02:19:32,560 --> 02:19:35,520 PEPTIDE LIPOSOME WHICH INDUCES 3659 02:19:35,520 --> 02:19:39,160 LOW LEVELS OF HETEROLOGOUS 3660 02:19:39,160 --> 02:19:39,920 NEUTRALIZING ANTIBODIES. 3661 02:19:39,920 --> 02:19:42,040 IF YOU CAN SKIP THROUGH THE NEXT 3662 02:19:42,040 --> 02:19:43,280 THREE SLIDES REALLY QUICKLY. 3663 02:19:43,280 --> 02:19:45,920 I CAN WRAP THIS UP. 3664 02:19:45,920 --> 02:19:48,640 IT'S THE DATA SLIDE, YOU HAVE 3665 02:19:48,640 --> 02:19:50,480 THOSE IN YOUR DECK TO REVIEW, 3666 02:19:50,480 --> 02:19:51,480 NEUTRALIZING ANTIBODIES. 3667 02:19:51,480 --> 02:19:56,400 I WANTED TO GO TO THE NIAID HIV 3668 02:19:56,400 --> 02:19:56,880 ANTIBODY PORTFOLIO. 3669 02:19:56,880 --> 02:19:58,840 BY NIAID I MEAN THE VACCINE 3670 02:19:58,840 --> 02:19:59,680 RESEARCH CENTER AND THE DIVISION 3671 02:19:59,680 --> 02:20:00,280 OF AIDS. 3672 02:20:00,280 --> 02:20:02,880 THERE IS A TRIPLE ANTIBODY 3673 02:20:02,880 --> 02:20:03,720 COMBINATION THAT IS THOUGHT TO 3674 02:20:03,720 --> 02:20:06,800 BE THE MOST EFFECTIVE FOR 3675 02:20:06,800 --> 02:20:08,240 PREVENTION. 3676 02:20:08,240 --> 02:20:12,960 THIS INVOLVES AN ANTIBODIES AGAT 3677 02:20:12,960 --> 02:20:20,720 THE BINDING SITE -- POTENCY 3678 02:20:20,720 --> 02:20:21,600 BREADTH CURVES IN THE UPPER 3679 02:20:21,600 --> 02:20:24,000 RIGHT IN RED, YOU SEE THE TRIPLE 3680 02:20:24,000 --> 02:20:27,840 COMBINATION THAT WE'VE SELECTED 3681 02:20:27,840 --> 02:20:28,920 THAT SHOULD PROVIDE HIGH LEVELS 3682 02:20:28,920 --> 02:20:35,280 OF PROTECTION AGAINST BOTH -- 3683 02:20:35,280 --> 02:20:39,880 VIRUSES. 3684 02:20:39,880 --> 02:20:43,680 JUST WANTED TO STATE THIS WAS 3685 02:20:43,680 --> 02:20:44,800 IMPORTANT THAT A PAPER FROM 3686 02:20:44,800 --> 02:20:47,960 PETER GILBERT THAT ESTABLISHED A 3687 02:20:47,960 --> 02:20:56,280 NEUTRALIZATION TITER BIOMARKER, 3688 02:20:56,280 --> 02:21:01,280 AN IMPORTANT TARGET FOR US, ID80 3689 02:21:01,280 --> 02:21:04,800 TITERS ARE PREDICTED TO OFFER 3690 02:21:04,800 --> 02:21:13,280 90% EFFICACY. 3691 02:21:13,280 --> 02:21:14,960 THESE ARE THE BNAB VACCINES IN 3692 02:21:14,960 --> 02:21:15,440 THE PIPELINE. 3693 02:21:15,440 --> 02:21:24,000 THIS IS THE FIRST IN HUMAN -- 3694 02:21:24,000 --> 02:21:25,960 VACCIVACCINE THAT'S PLANNED THAT 3695 02:21:25,960 --> 02:21:28,040 SHOULD START THIS YEAR. 3696 02:21:28,040 --> 02:21:30,000 WE CONCEDE WE'LL LIKELY NEED 3697 02:21:30,000 --> 02:21:31,640 MULTICOMPONENT VACCINES TO 3698 02:21:31,640 --> 02:21:33,840 TARGET MULTIPLE NEUTRALIZATION 3699 02:21:33,840 --> 02:21:36,160 EPITOPES AND WILL PROBABLY NEED 3700 02:21:36,160 --> 02:21:38,680 THESE CELLULAR BASED VACCINES TO 3701 02:21:38,680 --> 02:21:42,600 COME IN AND HELP US REACH THE 3702 02:21:42,600 --> 02:21:44,240 GOAL OF AN HIV VACCINE TO HELP 3703 02:21:44,240 --> 02:21:47,840 END THE EPIDEMIC. 3704 02:21:47,840 --> 02:21:49,720 WE THINK AN HIV VACCINE REMAINS 3705 02:21:49,720 --> 02:21:50,600 ESSENTIAL TO CONTROL THE 3706 02:21:50,600 --> 02:21:50,960 EPIDEMIC. 3707 02:21:50,960 --> 02:21:53,000 THANK YOU VERY MUCH. 3708 02:21:53,000 --> 02:21:55,160 I APPRECIATE ANY EXTRA TIME AND 3709 02:21:55,160 --> 02:21:57,040 CAN TAKE QUESTIONS OR SAVE THEM 3710 02:21:57,040 --> 02:21:58,800 FOR LATER. 3711 02:21:58,800 --> 02:21:59,360 THANKS, KEN. 3712 02:21:59,360 --> 02:22:05,240 >>THANK YOU, DR. MAROVICH, THAT 3713 02:22:05,240 --> 02:22:06,440 WAS FANTASTIC, SO MUCH PROGRESS 3714 02:22:06,440 --> 02:22:07,760 AND IT PARTICULARLY EXCITING TO 3715 02:22:07,760 --> 02:22:11,360 SEE HOW MUCH OF THAT SCIENCE WAS 3716 02:22:11,360 --> 02:22:12,800 USED IN THE COVID VACCINES AND 3717 02:22:12,800 --> 02:22:16,960 NO DOUBT WILL BE IN THE 3718 02:22:16,960 --> 02:22:19,920 SUCCESSFUL -- TO BE COMING 3719 02:22:19,920 --> 02:22:21,240 SUCCESSFUL -- IN THE INTEREST OF 3720 02:22:21,240 --> 02:22:23,240 TIME IS HOLD QUESTIONS HERE 3721 02:22:23,240 --> 02:22:24,360 UNTIL WE DO HAVE SOME TIME AT 3722 02:22:24,360 --> 02:22:28,240 THE END IF THAT'S OKAY. 3723 02:22:28,240 --> 02:22:38,320 AND WE WILL CONTINUE WITH 3724 02:22:38,320 --> 02:22:40,400 DR. SHERYL ZWERSKI, PREVENTION 3725 02:22:40,400 --> 02:22:41,040 SCIENCES PROGRAM. 3726 02:22:41,040 --> 02:22:42,640 SO LET ME TURN IT OVER TO 3727 02:22:42,640 --> 02:22:42,920 DR. ZWERSKI. 3728 02:22:42,920 --> 02:22:43,560 >>OKAY. 3729 02:22:43,560 --> 02:22:49,720 CAN EVERYONE HEAR ME? 3730 02:22:49,720 --> 02:22:50,320 >>YES. 3731 02:22:50,320 --> 02:22:51,520 >>EXCELLENT. 3732 02:22:51,520 --> 02:22:52,640 GOOD AFTERNOON, EVERYONE. 3733 02:22:52,640 --> 02:22:53,880 THANK YOU VERY MUCH FOR THE 3734 02:22:53,880 --> 02:22:54,520 OPPORTUNITY TO TALK ABOUT THE 3735 02:22:54,520 --> 02:22:55,760 WORK OF THE PREVENTION SCIENCES 3736 02:22:55,760 --> 02:22:56,080 PROGRAM. 3737 02:22:56,080 --> 02:22:57,760 WHAT WE'VE DONE IN THE PAST YEAR 3738 02:22:57,760 --> 02:23:04,360 AND KIND OF THE WAYS FORWARD. 3739 02:23:04,360 --> 02:23:05,800 SO I'M GOING TO GO OVER A LITTLE 3740 02:23:05,800 --> 02:23:07,240 BIT OF BACKGROUND. 3741 02:23:07,240 --> 02:23:09,360 SOME ORIENTATION TO THE PROGRAM. 3742 02:23:09,360 --> 02:23:14,080 SOME OF OUR 2022 ACCOMPLISHMENT 3743 02:23:14,080 --> 02:23:14,400 HIGHLIGHTS. 3744 02:23:14,400 --> 02:23:15,920 KIND OF WHAT WE SEE AS COMING 3745 02:23:15,920 --> 02:23:17,280 NEXT, WHAT ARE THE CHALLENGES 3746 02:23:17,280 --> 02:23:18,240 AND OPPORTUNITIES ASSOCIATED 3747 02:23:18,240 --> 02:23:20,240 WITH THAT. 3748 02:23:20,240 --> 02:23:23,160 AND THEN OF COURSE TAKE ANY 3749 02:23:23,160 --> 02:23:24,960 QUESTIONS AS WE'RE ABLE. 3750 02:23:24,960 --> 02:23:30,120 OKAY? 3751 02:23:30,120 --> 02:23:31,960 SO A LOT OF THIS, YOU ALL KNOW 3752 02:23:31,960 --> 02:23:36,120 BUT I THINK FOR US IS WE THINK 3753 02:23:36,120 --> 02:23:37,880 ABOUT KIND OF WHAT IS NEXT IN 3754 02:23:37,880 --> 02:23:39,480 THE WAY FORWARD REALLY IMPORTANT 3755 02:23:39,480 --> 02:23:41,920 FOR US TO KEEP THESE THINGS, YOU 3756 02:23:41,920 --> 02:23:45,320 KNOW, THESE FACTS AND FIGURES IN 3757 02:23:45,320 --> 02:23:50,680 MIND, REALLY IMPORTANT PIECE IS 3758 02:23:50,680 --> 02:23:54,160 1.5 MILLION NEW INFECTIONS IN 3759 02:23:54,160 --> 02:23:55,080 2021. 3760 02:23:55,080 --> 02:23:58,160 AND THEN THIS IS WHAT WE'RE 3761 02:23:58,160 --> 02:24:02,240 LOOKING AT ON A D A DAILY BASIS. 3762 02:24:02,240 --> 02:24:09,600 SO ABOUT 430 CHILDREN UNDER THE 3763 02:24:09,600 --> 02:24:11,200 AGE OF 15 OF THE NEW INFECTIONS 3764 02:24:11,200 --> 02:24:18,040 PER DAY. 3765 02:24:18,040 --> 02:24:21,760 AND JUST AGAIN PROBABLY A KNOWN, 3766 02:24:21,760 --> 02:24:23,640 NO SURPRISE TO ANYONE HERE, THAT 3767 02:24:23,640 --> 02:24:24,480 WE'RE CERTAINLY NOT GOING TO 3768 02:24:24,480 --> 02:24:26,360 MEET OUR TARGET OR IT APPEARS 3769 02:24:26,360 --> 02:24:29,440 NOT, FOR THE 2025 DECREASE IN 3770 02:24:29,440 --> 02:24:39,840 NUMBER OF NEW INFECTIONS 3771 02:24:40,960 --> 02:24:42,720 GLOBALLY. 3772 02:24:42,720 --> 02:24:48,280 AND THEN A REMINDER TO US OF HOW 3773 02:24:48,280 --> 02:24:52,600 THE NEW INFECTIONS RIGHT DOWN BY 3774 02:24:52,600 --> 02:24:53,160 POPULATION. 3775 02:24:53,160 --> 02:24:57,320 MANY KEY POPULATIONS, OF COURSE, 3776 02:24:57,320 --> 02:24:59,680 IN SUB-SAHARAN AFRICA, A LOT OF 3777 02:24:59,680 --> 02:25:02,480 MORE GENERAL POPULATION, BUT 3778 02:25:02,480 --> 02:25:03,920 AGAIN CRITICAL FOR US TO THINK 3779 02:25:03,920 --> 02:25:06,680 OF AS WE THINK OF WHAT PRODUCTS, 3780 02:25:06,680 --> 02:25:08,920 WHAT CHOICES, WHAT 3781 02:25:08,920 --> 02:25:10,280 INTERVENTIONS, YOU KNOW, SHOULD 3782 02:25:10,280 --> 02:25:12,200 WE BE WORKING ON, SHOULD WE BE 3783 02:25:12,200 --> 02:25:18,640 TESTING NEXT. 3784 02:25:18,640 --> 02:25:20,160 AND AGAIN, HERE IS NUMBER OF 3785 02:25:20,160 --> 02:25:23,240 PEOPLE WHO RECEIVED PREP, AT 3786 02:25:23,240 --> 02:25:25,080 LEAST ONCE DURING THE REPORTING 3787 02:25:25,080 --> 02:25:25,520 PERIOD. 3788 02:25:25,520 --> 02:25:27,840 AND AS YOU CAN SEE, EVERYBODY, 3789 02:25:27,840 --> 02:25:32,480 EVERY SINGLE REGION HERE 3790 02:25:32,480 --> 02:25:36,600 REPORTING IS RELATIVELY FAR OFF. 3791 02:25:36,600 --> 02:25:37,600 INTERESTINGLY, IF YOU LOOK AT 3792 02:25:37,600 --> 02:25:39,920 EASTERN AND SOUTHERN AFRICA AND 3793 02:25:39,920 --> 02:25:41,520 WESTERN AND CENTRAL AFRICA, AS 3794 02:25:41,520 --> 02:25:43,360 FAR AS RELATIVE TO TARGETS, 3795 02:25:43,360 --> 02:25:46,360 THEY'RE GETTING CLOSE TO 50%, 3796 02:25:46,360 --> 02:25:48,200 STILL A FAR WAYS OFF, BUT IF WE 3797 02:25:48,200 --> 02:25:51,000 LOOK AT ASIA AND THE PACIFIC, 3798 02:25:51,000 --> 02:25:53,440 LATIN AMERICA, EVEN WESTERN AND 3799 02:25:53,440 --> 02:25:54,600 CENTRAL EUROPE AND INCLUDING 3800 02:25:54,600 --> 02:25:56,640 NORTH AMERICA, WE ARE EVEN 3801 02:25:56,640 --> 02:26:05,680 FURTHER OFF ON OUR TARGETS. 3802 02:26:05,680 --> 02:26:07,080 THIS IS REALLY SHOWING NEW 3803 02:26:07,080 --> 02:26:09,560 INFECTIONS IN CHILDREN AS 3804 02:26:09,560 --> 02:26:11,480 OPPOSED TO ANTIRETROVIRAL 3805 02:26:11,480 --> 02:26:13,320 COVERAGE AMONG PREGNANT WOMEN 3806 02:26:13,320 --> 02:26:15,120 GLOBALLY. 3807 02:26:15,120 --> 02:26:15,920 BETWEEN 2010 AS YOU CAN SEE HERE 3808 02:26:15,920 --> 02:26:18,120 AND AGAIN 21, IT'S IMPORTANT, OF 3809 02:26:18,120 --> 02:26:19,680 COURSE, TO US AS WE THINK ABOUT, 3810 02:26:19,680 --> 02:26:23,200 YOU KNOW, ADVANCING MA TEERNL 3811 02:26:23,200 --> 02:26:26,040 AND CHILD HIV TREATMENT. 3812 02:26:26,040 --> 02:26:28,120 AS YOU CAN SEE CERTAINLY THE 3813 02:26:28,120 --> 02:26:33,240 COVERAGE IN WOMEN ROSE FROM 2010 3814 02:26:33,240 --> 02:26:34,240 SIGNIFICANTLY, BEEN RELATIVELY 3815 02:26:34,240 --> 02:26:37,960 LEVEL OVER THE LAST SEVERAL 3816 02:26:37,960 --> 02:26:39,400 YEARS, AND THAT THE INFECTIONS 3817 02:26:39,400 --> 02:26:41,000 IN CHILDREN HAVE COME DOWN 3818 02:26:41,000 --> 02:26:42,520 SIGNIFICANTLY WHEN WE LOOK FROM 3819 02:26:42,520 --> 02:26:45,920 2010 TO WHERE WE ARE, BULL NOT 3820 02:26:45,920 --> 02:26:48,760 DRASTIC DIFFERENCES OVER THE 3821 02:26:48,760 --> 02:26:50,040 LAST COUPLE YEARS AND THE LAST 3822 02:26:50,040 --> 02:26:50,960 SEVERAL YEARS. 3823 02:26:50,960 --> 02:26:52,720 SO IMPORTANT FOR US AS WE THINK 3824 02:26:52,720 --> 02:26:54,040 ABOUT, YOU KNOW, WHAT WE NEED TO 3825 02:26:54,040 --> 02:27:04,600 DO IN THIS SPACE MOVING FORWARD. 3826 02:27:07,200 --> 02:27:08,840 SO THIS WAS A RECENT ARTICLE IN 3827 02:27:08,840 --> 02:27:09,440 THE "NEW YORK TIMES" ABOUT THE 3828 02:27:09,440 --> 02:27:13,880 GLOBAL PUSH TO TREAT HIV AND HOW 3829 02:27:13,880 --> 02:27:15,880 THAT IS -- HOW CHILDREN ARE 3830 02:27:15,880 --> 02:27:17,280 BEING LEFT BEHIND IN THAT 3831 02:27:17,280 --> 02:27:17,560 EFFORT. 3832 02:27:17,560 --> 02:27:19,000 IT'S REALLY A NUMBER OF 3833 02:27:19,000 --> 02:27:23,800 DIFFERENT REASONS, AND VARY SOME 3834 02:27:23,800 --> 02:27:25,720 OF COURSE FROM PLACE TO PLACE, 3835 02:27:25,720 --> 02:27:26,800 BUT ULTIMATELY RIGHT NOW WE'RE 3836 02:27:26,800 --> 02:27:30,400 AT THE POINT WHERE ABOUT 76% OF 3837 02:27:30,400 --> 02:27:31,840 ADULTS WHO NEED HIV TREATMENT 3838 02:27:31,840 --> 02:27:33,800 ARE ON TREATMENT, BUT ONLY ABOUT 3839 02:27:33,800 --> 02:27:37,320 50% FOR CHILDREN. 3840 02:27:37,320 --> 02:27:39,040 AS I SAID, A NUMBER OF REASONS. 3841 02:27:39,040 --> 02:27:42,000 OFTENTIMES CHILDREN ARE NOT 3842 02:27:42,000 --> 02:27:46,600 BEING FOUND AS FAR AS NEEDING OR 3843 02:27:46,600 --> 02:27:47,280 IDENTIFIED AS NEEDING HIV 3844 02:27:47,280 --> 02:27:47,760 TESTING. 3845 02:27:47,760 --> 02:27:49,080 SOMETIMES, YOU KNOW, TEST KIT 3846 02:27:49,080 --> 02:27:53,480 ARE OUT OF STOCK, OTHER TIMES 3847 02:27:53,480 --> 02:27:55,760 ANTIRETROVIRALS FOR CHILDREN, 3848 02:27:55,760 --> 02:27:57,640 THE FREE ANTIRETROVIRALS ARE OUT 3849 02:27:57,640 --> 02:27:58,520 OF STOCK. 3850 02:27:58,520 --> 02:27:59,640 OCCASIONALLY FOR MOTHERS AS 3851 02:27:59,640 --> 02:28:00,320 WELL. 3852 02:28:00,320 --> 02:28:03,440 AND AS WE ALL KNOW, THE COVID 3853 02:28:03,440 --> 02:28:05,120 PANDEMIC HAS NOT HELPED THIS 3854 02:28:05,120 --> 02:28:07,200 SITUATION AT ALL AND PROBABLY 3855 02:28:07,200 --> 02:28:11,040 SET US FURTHER BEHIND, SO 3856 02:28:11,040 --> 02:28:12,880 THINKING ABOUT OUR WORK AS TO 3857 02:28:12,880 --> 02:28:15,080 WHAT OUR PIECES IN THIS ARE, 3858 02:28:15,080 --> 02:28:17,960 WE'LL TALK ABOUT THIS A LITTLE 3859 02:28:17,960 --> 02:28:18,840 BIT MORE IN THE PRESENTATION 3860 02:28:18,840 --> 02:28:24,520 LATER, BUT ONE OF OUR MAJOR 3861 02:28:24,520 --> 02:28:26,600 FOCUSES IS GETTING THE OPTIMAL 3862 02:28:26,600 --> 02:28:28,160 TREATMENT, PROVING THEY'RE SAFE 3863 02:28:28,160 --> 02:28:29,600 AND EFFECTIVE, THE CORRECT 3864 02:28:29,600 --> 02:28:31,320 DOSING IN CHILDREN, AND IN 3865 02:28:31,320 --> 02:28:34,600 PREGNANT WOMEN, AND THEN THAT 3866 02:28:34,600 --> 02:28:36,120 LEAVES ALL THESE IMPLEMENTATION 3867 02:28:36,120 --> 02:28:39,080 ISSUES, WHICH ARE NOT SO MUCH 3868 02:28:39,080 --> 02:28:42,640 DIRECTLY NIAID, BUT I THINK 3869 02:28:42,640 --> 02:28:46,160 WE'LL TALK ABOUT KIND OF HOW WE 3870 02:28:46,160 --> 02:28:48,080 TRY AND THINK ABOUT PARTNERING 3871 02:28:48,080 --> 02:28:50,240 MAYBE SOMETIMES WITH 3872 02:28:50,240 --> 02:28:51,000 NON-TRADITIONAL PARTNERS ON 3873 02:28:51,000 --> 02:28:54,160 SPECIFIC SLICES OF 3874 02:28:54,160 --> 02:28:54,760 IMPLEMENTATION, BUT IMPORTANT 3875 02:28:54,760 --> 02:29:05,160 FOR US TO KEEP IN MIND. 3876 02:29:05,560 --> 02:29:06,920 SO I WANT TO INTRODUCE YOU ALL 3877 02:29:06,920 --> 02:29:09,320 TO THE PREVENTION SCIENCES 3878 02:29:09,320 --> 02:29:10,600 PROGRAM, A LITTLE BIT ABOUT THE 3879 02:29:10,600 --> 02:29:12,080 STAFF, WHAT CHANGES WE'VE HAD IN 3880 02:29:12,080 --> 02:29:13,240 THIS PAST YEAR. 3881 02:29:13,240 --> 02:29:16,680 I ALSO WANT TO, THOUGH, 3882 02:29:16,680 --> 02:29:18,000 ACKNOWLEDGE, IN ADDITION TO THE 3883 02:29:18,000 --> 02:29:20,840 EXTRAORDINARY WORK THAT ALL OF 3884 02:29:20,840 --> 02:29:25,080 THE STAFF IN PSP DO, IT TAKES 3885 02:29:25,080 --> 02:29:26,000 EVERY ONE OF US CONTRIBUTING TO 3886 02:29:26,000 --> 02:29:27,120 THE MISSION TO BE ABLE TO DO THE 3887 02:29:27,120 --> 02:29:29,520 WORK THAT WE'RE DOING, WE ALSO 3888 02:29:29,520 --> 02:29:30,920 PARTNER ACROSS ALL OF THE 3889 02:29:30,920 --> 02:29:37,520 SCIENTIFIC PROGRAMS, SO BASIC 3890 02:29:37,520 --> 02:29:40,320 SCIENCES, THERAPEUTIC SCIENCE, 3891 02:29:40,320 --> 02:29:41,240 VACCINE RESEARCH PROGRAM, BUT 3892 02:29:41,240 --> 02:29:42,840 FOR THE WORK THAT WE OFTEN DO, 3893 02:29:42,840 --> 02:29:45,080 WHICH ARE THE REGISTRATIONAL 3894 02:29:45,080 --> 02:29:47,200 STUDIES FOR PRODUCTS, WE ARE 3895 02:29:47,200 --> 02:29:49,280 VERY CLOSE -- WE WORK VERY 3896 02:29:49,280 --> 02:29:53,440 CLOSELY WITH BOTH OUR 3897 02:29:53,440 --> 02:29:54,440 COLLEAGUES, THERE'S NO WAY WE 3898 02:29:54,440 --> 02:29:55,960 COULD DO THIS WORK WITHOUT THEM, 3899 02:29:55,960 --> 02:29:59,560 AND THEN OF COURSE OFTENTIMES 3900 02:29:59,560 --> 02:30:02,760 IT'S MORPHED ACROSS INSTITUTES, 3901 02:30:02,760 --> 02:30:07,280 PARTICULARLY WITH NIMH, NICHD, 3902 02:30:07,280 --> 02:30:10,920 OAR AND OTHERS, AND AS WELL AS 3903 02:30:10,920 --> 02:30:11,880 PHARMA PARTNERS AND OTHER 3904 02:30:11,880 --> 02:30:12,720 PARTNERS THAT ARE CRITICAL TO 3905 02:30:12,720 --> 02:30:23,040 THE WORK THAT WE DO. 3906 02:30:28,040 --> 02:30:29,240 SO JUST A LITTLE BIT OF 3907 02:30:29,240 --> 02:30:30,280 ORIENTATION HERE AND I'LL POINT 3908 02:30:30,280 --> 02:30:31,480 OUT THE CHANGES WE'VE HAD IN THE 3909 02:30:31,480 --> 02:30:32,040 LAST YEAR. 3910 02:30:32,040 --> 02:30:36,200 WE ARE IS THE HAVE THE FOUR BRL 3911 02:30:36,200 --> 02:30:37,480 AND THEN KIND OF THE FUNCTIONAL 3912 02:30:37,480 --> 02:30:38,320 GROUPS THERE WITHIN THE OFFICE 3913 02:30:38,320 --> 02:30:39,880 OF THE DIRECTOR. 3914 02:30:39,880 --> 02:30:41,520 THE ADMINISTRATIVE GROUP, AND 3915 02:30:41,520 --> 02:30:43,600 THEN THE REGISTRATIONAL TRIALS 3916 02:30:43,600 --> 02:30:44,920 AND COLLABORATIVE PARTNERSHIPS 3917 02:30:44,920 --> 02:30:46,880 GROUP THAT REALLY WORK ON 3918 02:30:46,880 --> 02:30:50,480 MANAGING ALL OF THE -- BACK, 3919 02:30:50,480 --> 02:30:54,320 PLEASE -- ALL OF THE 3920 02:30:54,320 --> 02:30:55,200 REQUIREMENTS THAT WE NEED TO 3921 02:30:55,200 --> 02:30:56,800 MEET FOR OUR REGISTRATIONAL 3922 02:30:56,800 --> 02:30:59,040 TRIALS AND REALLY TAKING A 3923 02:30:59,040 --> 02:31:02,800 PROJECT MANAGEMENT SORT OF 3924 02:31:02,800 --> 02:31:03,480 APPROACH THERE. 3925 02:31:03,480 --> 02:31:08,040 OUR FOUR BRANCHES, THE 3926 02:31:08,040 --> 02:31:09,040 PRE-CLINICAL MICROBICIDE AND 3927 02:31:09,040 --> 02:31:11,120 PREVENTION RESEARCH BRANCH, 3928 02:31:11,120 --> 02:31:12,440 DR. LESLIE MARSHAL WENT TO OAR 3929 02:31:12,440 --> 02:31:16,360 AS MANY OF YOU KNOW, AND -- WE 3930 02:31:16,360 --> 02:31:19,680 HIRED DR. B ARC RNA DAY AS A 3931 02:31:19,680 --> 02:31:20,560 PROGRAM OFFICER IN THIS GROUP 3932 02:31:20,560 --> 02:31:21,760 AND WE'RE VERY PLEASED THAT 3933 02:31:21,760 --> 02:31:25,600 SHE'S JOINED US. 3934 02:31:25,600 --> 02:31:27,120 OUR CLINICAL MICROBICIDE 3935 02:31:27,120 --> 02:31:27,920 RESEARCH BRANCH HAS STAYED THE 3936 02:31:27,920 --> 02:31:28,480 SAME. 3937 02:31:28,480 --> 02:31:34,600 THE CLINICAL PREVENTION RESEARCH 3938 02:31:34,600 --> 02:31:36,080 BRANCH, THE BRANCH CHIEF IS IN 3939 02:31:36,080 --> 02:31:37,640 THE COMMISSION CORPS AND WOUND 3940 02:31:37,640 --> 02:31:44,720 UP TAKING A POSITION AT THE 3941 02:31:44,720 --> 02:31:46,720 EMBASSY IN NIGERIA TO REALLY 3942 02:31:46,720 --> 02:31:47,720 CONTRIBUTE THERE. 3943 02:31:47,720 --> 02:31:49,120 SO I'VE BEEN THE ACTING BRANCH 3944 02:31:49,120 --> 02:31:50,760 CHIEF FOR THE LAST SIX MONTHS 3945 02:31:50,760 --> 02:31:52,560 FOR THIS GROUP. 3946 02:31:52,560 --> 02:31:56,800 LYDIA SOTO-TORRES CONTINUES TO 3947 02:31:56,800 --> 02:31:59,000 SERVE AS THE DEPUTY, AND WE HAVE 3948 02:31:59,000 --> 02:32:01,840 HIRED DR. JAMAL DEJLI AS A NEW 3949 02:32:01,840 --> 02:32:03,280 PROGRAM OFFICER IN THIS BRANCH 3950 02:32:03,280 --> 02:32:04,040 AND WE'RE VERY PLEASED THAT HE 3951 02:32:04,040 --> 02:32:06,560 IS THERE. 3952 02:32:06,560 --> 02:32:08,480 IN THE MATERNAL ADOLESCENT AND 3953 02:32:08,480 --> 02:32:19,000 PEDIATRIC RESEARCH BRANCH, WE 3954 02:32:20,480 --> 02:32:25,360 HAVE RECENTLY GAINED 3955 02:32:25,360 --> 02:32:27,400 DR. CHRISTINE CHIOU, SERVING AS 3956 02:32:27,400 --> 02:32:28,400 PROGRAM OFFICER, A MEDICAL 3957 02:32:28,400 --> 02:32:32,600 OFFICER AND ALSO HAS PROJECT 3958 02:32:32,600 --> 02:32:33,840 OFFICER OR CORE CERTIFICATIONS, 3959 02:32:33,840 --> 02:32:36,400 SO WE'RE REALLY THRILLED FOR HER 3960 02:32:36,400 --> 02:32:46,640 ADDITION ALSO. 3961 02:32:53,720 --> 02:32:56,280 JUST A REMINDER, YOU ALL HAVE 3962 02:32:56,280 --> 02:32:58,200 SEEN THIS BEFORE, OUR REALLY 3963 02:32:58,200 --> 02:33:00,880 HIGH LEVEL OBJECTIVES HAVE NOT 3964 02:33:00,880 --> 02:33:02,160 CHANGED. 3965 02:33:02,160 --> 02:33:03,840 JUST AS A REMINDER, DEVELOPMENT 3966 02:33:03,840 --> 02:33:05,200 OF HIV PREVENTION PROJECTS, 3967 02:33:05,200 --> 02:33:06,480 FURTHER UNDERSTANDING THE 3968 02:33:06,480 --> 02:33:08,160 BIOLOGY OF HIV SUSCEPTIBILITY, 3969 02:33:08,160 --> 02:33:11,640 AND THEN WORKING WITH PARTNERS 3970 02:33:11,640 --> 02:33:13,480 ON IMPROVING ENGAGEMENT OF KEY 3971 02:33:13,480 --> 02:33:13,840 POPULATIONS. 3972 02:33:13,840 --> 02:33:17,880 AS WE MOVE TO THE MATERNAL CHILD 3973 02:33:17,880 --> 02:33:19,520 PRIORITIES, REALLY IMPROVING HIV 3974 02:33:19,520 --> 02:33:21,720 TREATMENT AND PREVENTION IN 3975 02:33:21,720 --> 02:33:24,480 PREGNANT WOMEN AND CHILDREN, AND 3976 02:33:24,480 --> 02:33:27,040 THEN OPTIMIZING STRATEGIES TO 3977 02:33:27,040 --> 02:33:28,760 DIAGNOSE, TREAT AND PREVENT TB 3978 02:33:28,760 --> 02:33:30,840 IN BOTH THE MATERNAL AND 3979 02:33:30,840 --> 02:33:35,360 PEDIATRIC POPULATIONS, AND THEN 3980 02:33:35,360 --> 02:33:37,000 CONTRIBUTING TO AND EVOLVING THE 3981 02:33:37,000 --> 02:33:38,520 HIV-FREE REMISSION OR CURE 3982 02:33:38,520 --> 02:33:41,600 RESEARCH AGENDA IN INFANTS AND 3983 02:33:41,600 --> 02:33:51,760 CHILDREN. 3984 02:33:56,320 --> 02:33:58,120 SO THIS IS A LISTING OF OUR 3985 02:33:58,120 --> 02:33:59,320 CURRENT PSP PROGRAMS. 3986 02:33:59,320 --> 02:34:00,760 OF COURSE IN ADDITION TO THESE 3987 02:34:00,760 --> 02:34:03,840 PROGRAMS, WE HAVE A NUMBER OF 3988 02:34:03,840 --> 02:34:07,000 INVESTIGATOR-INITIATED GRANTS 3989 02:34:07,000 --> 02:34:08,080 THAT ALSO, OF COURSE, CONTRIBUTE 3990 02:34:08,080 --> 02:34:09,160 TO THE MISSION OF THE PROGRAM. 3991 02:34:09,160 --> 02:34:11,080 JUST TO ORIENT YOU HERE A 3992 02:34:11,080 --> 02:34:20,560 LITTLE, YOU CAN SEE ALONG THE 3993 02:34:20,560 --> 02:34:21,840 BOTTOM, WE HAVE THE PRODUCT 3994 02:34:21,840 --> 02:34:23,280 DEVELOPMENT OR AXIS THERE 3995 02:34:23,280 --> 02:34:25,120 STARTING SOME OF OUR WORK IN 3996 02:34:25,120 --> 02:34:26,240 DISCOVERY GOING ALL THE WAY 3997 02:34:26,240 --> 02:34:28,320 THROUGH PRE-CLINICAL, 3998 02:34:28,320 --> 02:34:29,360 TRANSLATIONAL, PRE-PHASE ONE, 3999 02:34:29,360 --> 02:34:30,840 AND THEN ALL THE WAY THROUGH 4000 02:34:30,840 --> 02:34:33,720 PHASE ONE, TWO AND THREE IN THE 4001 02:34:33,720 --> 02:34:37,200 LATER CLINICAL TESTING. 4002 02:34:37,200 --> 02:34:39,560 JUST TO ORIENT YOU A BIT, THE 4003 02:34:39,560 --> 02:34:41,280 COLOR SCHEME THERE, THE LIGHTER 4004 02:34:41,280 --> 02:34:44,240 GREEN IS MORE MATERNAL PEDIATRIC 4005 02:34:44,240 --> 02:34:46,800 FOCUSED, THE DARKER GREEN MORE 4006 02:34:46,800 --> 02:34:50,280 ADULT ADOLESCENT AND ADULT HIV 4007 02:34:50,280 --> 02:34:51,280 PREVENTION FOCUSED, AND AS YOU 4008 02:34:51,280 --> 02:34:52,640 CAN SEE, SOME OF THESE PROGRAMS 4009 02:34:52,640 --> 02:34:57,320 AND INITIATIVES ARE BOTH. 4010 02:34:57,320 --> 02:34:58,720 HAVE A FOCUS IN BOTH AREAS. 4011 02:34:58,720 --> 02:35:02,680 AT THE BOTTOM ARE WHAT WE'VE 4012 02:35:02,680 --> 02:35:04,440 CALLED OUR CRIMP CONTRIBUTE, 4013 02:35:04,440 --> 02:35:07,320 WHICH GOES THROUGH FY 2023, AND 4014 02:35:07,320 --> 02:35:09,840 THEN OF COURSE TAKING OVER ON 4015 02:35:09,840 --> 02:35:14,960 THE NEXT ITERATION WILL BE OUR 4016 02:35:14,960 --> 02:35:16,320 RAPPS CONTRACT, REALLY SERVE AS 4017 02:35:16,320 --> 02:35:17,960 A BASIS AND AS A PLATFORM, IF 4018 02:35:17,960 --> 02:35:20,640 YOU WILL, GAP-FILLING SERVICES 4019 02:35:20,640 --> 02:35:23,160 AS WE MOVE ALONG FROM THE 4020 02:35:23,160 --> 02:35:24,440 PRE-CLINICAL THROUGH THE LATER 4021 02:35:24,440 --> 02:35:26,520 CLINICAL TESTING STAGES, AND 4022 02:35:26,520 --> 02:35:28,720 THEN OTHERS OF THESE ARE VERY 4023 02:35:28,720 --> 02:35:30,720 SPECIFICALLY FOCUSED AND THEN WE 4024 02:35:30,720 --> 02:35:34,800 HAVE THE TWO NETWORKS, THE HTPTN 4025 02:35:34,800 --> 02:35:36,120 AND THE IMPACT NETWORK THAT A 4026 02:35:36,120 --> 02:35:41,920 LOT OF THIS WORK, WHEN IT GETS 4027 02:35:41,920 --> 02:35:42,840 TRANSLATED INTO CLINICAL 4028 02:35:42,840 --> 02:35:49,720 TESTING, THAT'S WHERE WE MOVE 4029 02:35:49,720 --> 02:35:50,160 TO. 4030 02:35:50,160 --> 02:35:51,400 SO I WANT TO TAKE A MOMENT AND 4031 02:35:51,400 --> 02:35:53,480 GO OVER SOME 2022 ACCOMPLISHMENT 4032 02:35:53,480 --> 02:35:54,000 HIGHLIGHTS. 4033 02:35:54,000 --> 02:35:57,080 THIS IS BY NO MEANS AN 4034 02:35:57,080 --> 02:35:57,640 ALL-INCLUSIVE LIST. 4035 02:35:57,640 --> 02:36:00,200 IT'S BEEN A REALLY PRODUCTIVE 4036 02:36:00,200 --> 02:36:02,040 YEAR AND THESE ARE JUST SOME 4037 02:36:02,040 --> 02:36:12,440 HIGH LEVEL HIGHLIGHTS. 4038 02:36:15,800 --> 02:36:17,960 SO STARTING IN THE AREA OF 4039 02:36:17,960 --> 02:36:22,560 DEVELOPMENT OF HIV PREVENTION 4040 02:36:22,560 --> 02:36:23,800 PRODUCTS IN THE PAST YEAR, THE 4041 02:36:23,800 --> 02:36:27,080 SOUTH AFRICA, ZIMBABWE AND 4042 02:36:27,080 --> 02:36:27,560 AUSTRALIAN REGULATORY 4043 02:36:27,560 --> 02:36:31,760 AUTHORITIES HAVE APPROVED 4044 02:36:31,760 --> 02:36:32,840 CABOTEGRAVIR LONG-ACTING FOR 4045 02:36:32,840 --> 02:36:34,040 PREP IN INDIVIDUALS FROM 4046 02:36:34,040 --> 02:36:35,480 35 KILOGRAMS AND ABOVE, AND 4047 02:36:35,480 --> 02:36:36,600 THOSE WERE BASED OF COURSE ON 4048 02:36:36,600 --> 02:36:42,520 THE HPTN 083 AND 084 STUDIES. 4049 02:36:42,520 --> 02:36:45,200 WE'VE CONTINUED OUR ONGOING 4050 02:36:45,200 --> 02:36:47,560 SAFETY AND PK TRIALS OF 4051 02:36:47,560 --> 02:36:48,400 MONOCLONAL ANTIBODY 4052 02:36:48,400 --> 02:36:49,160 COMBINATIONS. 4053 02:36:49,160 --> 02:36:50,680 THIS IS WORK THAT WE DO VERY 4054 02:36:50,680 --> 02:36:55,280 MUCH IN COLLABORATION WITH OUR 4055 02:36:55,280 --> 02:37:00,320 VRP COLLEAGUES AS WELL AS IT'S A 4056 02:37:00,320 --> 02:37:02,120 COLLABORATION BETWEEN TWO 4057 02:37:02,120 --> 02:37:05,720 NETWORKS, THE HVTN AND THE HPTN. 4058 02:37:05,720 --> 02:37:07,120 THERE WAS ALSO THE COMPLETION OF 4059 02:37:07,120 --> 02:37:11,600 THE PRIMARY ANALYSIS OF MTN-043, 4060 02:37:11,600 --> 02:37:15,360 WHICH IS THE DAPIVIRINE RING IN 4061 02:37:15,360 --> 02:37:18,240 LACTATING MOTHER AND 4062 02:37:18,240 --> 02:37:19,200 MOTHER-INFANT PAIRS, THEIR 4063 02:37:19,200 --> 02:37:20,880 INFANTS ARE FOLLOWED, AND THAT 4064 02:37:20,880 --> 02:37:23,400 INFORMATION WILL BE PRESENTED AT 4065 02:37:23,400 --> 02:37:33,720 C ROI NEXT MONTH. 4066 02:37:35,800 --> 02:37:36,920 THEN CONTINUING ALONG WITH OUR 4067 02:37:36,920 --> 02:37:38,600 PRODUCT DEVELOPMENT AND OUR 4068 02:37:38,600 --> 02:37:45,080 FOCUS ON PEDIATRICS, AS I JUST 4069 02:37:45,080 --> 02:37:46,960 MENTIONED, OUR RAPP SRT WHICH 4070 02:37:46,960 --> 02:37:48,720 YOU ALL ARE AWARE OF, OF COURSE 4071 02:37:48,720 --> 02:37:50,280 THAT CONCEPT WAS BROUGHT TO YOU, 4072 02:37:50,280 --> 02:37:51,680 GOSH, PROBABLY A YEAR OR YEAR 4073 02:37:51,680 --> 02:37:55,240 AND A HALF AGO OR SO, WE HAD THE 4074 02:37:55,240 --> 02:37:57,840 RELEASE OF THE RFP IN MARCH, 4075 02:37:57,840 --> 02:37:59,920 THEN RECEIVED PROPOSALS IN THE 4076 02:37:59,920 --> 02:38:03,760 SUMMER, AND THEN HAD REVIEWS IN 4077 02:38:03,760 --> 02:38:06,080 THE FALL AND WE'RE ON TARGET TO 4078 02:38:06,080 --> 02:38:07,080 MAKE THE AWARDS IN SUMMER OF 4079 02:38:07,080 --> 02:38:07,520 THIS YEAR. 4080 02:38:07,520 --> 02:38:09,480 SO WE'RE VERY EXCITED ABOUT THIS 4081 02:38:09,480 --> 02:38:10,840 NEXT ITERATION OF THE 4082 02:38:10,840 --> 02:38:12,240 GAP-FILLING CONTRACT. 4083 02:38:12,240 --> 02:38:15,760 AND THEN WE'VE ALSO ESTABLISHED 4084 02:38:15,760 --> 02:38:17,320 COLLABORATIONS WITH WORLDWIDE 4085 02:38:17,320 --> 02:38:20,360 STAKEHOLDERS IN THE AREA OF 4086 02:38:20,360 --> 02:38:22,040 PEDIATRIC FORMULATION, PARTLY AS 4087 02:38:22,040 --> 02:38:26,680 AN OUTGROWTH OF RAPPS. 4088 02:38:26,680 --> 02:38:27,880 I APOLOGIZE FOR ALL OF THESE 4089 02:38:27,880 --> 02:38:28,520 ACRONYMS HERE. 4090 02:38:28,520 --> 02:38:30,160 THERE'S NO WAY THAT I WOULD HAVE 4091 02:38:30,160 --> 02:38:31,720 HAD ENOUGH ROOM TO EVER WRITE 4092 02:38:31,720 --> 02:38:34,000 THEM ON A SLIDE, SO -- AND MANY 4093 02:38:34,000 --> 02:38:35,880 OF YOU PROBABLY ALREADY KNOW 4094 02:38:35,880 --> 02:38:36,880 THESE, BUT JUST TO GO THROUGH A 4095 02:38:36,880 --> 02:38:40,600 COUPLE OF THEM, THE GAP-F STANDS 4096 02:38:40,600 --> 02:38:42,800 FOR THE GLOBAL ACCELERATOR FOR 4097 02:38:42,800 --> 02:38:44,920 PEDIATRIC FORMULATIONS. 4098 02:38:44,920 --> 02:38:48,320 IT'S WHO-HOSTED. 4099 02:38:48,320 --> 02:38:53,120 PADO-TB IS PEDIATRIC 4100 02:38:53,120 --> 02:38:53,680 ANTITUBERCULOUS DRUG 4101 02:38:53,680 --> 02:38:54,280 OPTIMIZATION GROUP. 4102 02:38:54,280 --> 02:38:57,120 THERE IS A PADO-HIV GROUP THAT 4103 02:38:57,120 --> 02:38:59,560 REALLY SETS THE PRIORITIES FOR 4104 02:38:59,560 --> 02:39:01,880 DEVELOPMENT IN THE AREA OF 4105 02:39:01,880 --> 02:39:04,560 ANTIREANTIRETROVIRAL, AND THEN E 4106 02:39:04,560 --> 02:39:06,360 WORKED WITH THE IQ CONSORTIUM 4107 02:39:06,360 --> 02:39:09,200 PEDIATRIC WORKING GROUP, 4108 02:39:09,200 --> 02:39:12,840 PRESENTER -- DR. JAMES CUMMINS 4109 02:39:12,840 --> 02:39:15,240 PRESENTED AT THE EUPFI WHICH IS 4110 02:39:15,240 --> 02:39:18,000 THE EU PEDIATRIC FORMULATIONS 4111 02:39:18,000 --> 02:39:18,640 INITIATIVE. 4112 02:39:18,640 --> 02:39:19,800 WE'LL TALK A LITTLE MORE ABOUT 4113 02:39:19,800 --> 02:39:29,960 THE ROME 6 ACTION PLAN. 4114 02:39:29,960 --> 02:39:32,160 THEN CONTINUING ON IN THE AREA 4115 02:39:32,160 --> 02:39:33,920 OF PREVENTION AND TREATMENT FOR 4116 02:39:33,920 --> 02:39:38,320 PREGNANT WOMEN AND CHILDREN, OUR 4117 02:39:38,320 --> 02:39:40,360 WORK HAS CONTRIBUTED TO THE 4118 02:39:40,360 --> 02:39:43,720 REGULATORY APPROVALS OF TRIUMEQ 4119 02:39:43,720 --> 02:39:46,000 FOR CHILDREN DOWN TO 4120 02:39:46,000 --> 02:39:48,600 14 KILOGRAMS, DORAVIRINE FOR 4121 02:39:48,600 --> 02:39:50,280 ADOLESCENTS ACTUALLY DOWN TO 4122 02:39:50,280 --> 02:39:53,640 35 KILOGRAMS, AND THEN CABENUVA 4123 02:39:53,640 --> 02:39:54,840 FOR TREATMENT DOWN TO 4124 02:39:54,840 --> 02:39:55,200 35 KILOGRAMS. 4125 02:39:55,200 --> 02:39:56,240 SO WE'RE VERY THRILLED WITH 4126 02:39:56,240 --> 02:39:58,000 THOSE APPROVALS. 4127 02:39:58,000 --> 02:40:00,840 WE OF COURSE COLLABORATED WITH 4128 02:40:00,840 --> 02:40:04,920 VIIV HEALTHCARE TO COMPLETE THE 4129 02:40:04,920 --> 02:40:07,200 SUBMISSIONS FOR TRIUMEC FOR 4130 02:40:07,200 --> 02:40:14,720 CHILDREN, AND WE'VE COLLABORATED 4131 02:40:14,720 --> 02:40:17,800 WITH GILEAD FOR REMDESIVIR FDA 4132 02:40:17,800 --> 02:40:20,720 SUBMISSION IN PREGNANT WOMEN. 4133 02:40:20,720 --> 02:40:23,960 WE PARTICIPATED USUALLY YEARLY 4134 02:40:23,960 --> 02:40:25,360 ALTHOUGH WITH COVID THERE WERE A 4135 02:40:25,360 --> 02:40:26,920 COUPLE YEARS WHERE THIS MEETING 4136 02:40:26,920 --> 02:40:28,440 WASN'T HELD WHERE THE WHO, THE 4137 02:40:28,440 --> 02:40:29,600 PEPFAR AND THE VATICAN COME 4138 02:40:29,600 --> 02:40:30,680 TOGETHER TO CONVENE THIS 4139 02:40:30,680 --> 02:40:31,480 MEETING. 4140 02:40:31,480 --> 02:40:33,480 THIS ONE WAS THE SIXTH 4141 02:40:33,480 --> 02:40:38,920 ITERATION, TO DEVELOP THE ROME V 4142 02:40:38,920 --> 02:40:41,080 AND TB TREATMENT AND PREVENTION 4143 02:40:41,080 --> 02:40:44,840 IN CHILDREN AND IN PREGNANT 4144 02:40:44,840 --> 02:40:45,400 WOMEN. 4145 02:40:45,400 --> 02:40:46,600 THERE ARE STAKEHOLDERS PRESENT 4146 02:40:46,600 --> 02:40:51,640 FROM ALL SECTORS THAT REALLY 4147 02:40:51,640 --> 02:40:53,280 TOUCH HIV AND TB TREATMENT IN 4148 02:40:53,280 --> 02:40:54,640 THESE POPULATIONS, AND THEY COME 4149 02:40:54,640 --> 02:40:55,840 TOGETHER TO IDENTIFY THE GAPS 4150 02:40:55,840 --> 02:40:57,960 AND HAVE EACH OF THE 4151 02:40:57,960 --> 02:40:59,680 STAKEHOLDERS MAKE RELEVANT 4152 02:40:59,680 --> 02:41:02,440 COMMITMENTS IN THE AREAS THAT 4153 02:41:02,440 --> 02:41:03,760 ARE SPECIFIC TO THEM TO MOVE 4154 02:41:03,760 --> 02:41:06,920 THINGS FORWARD. 4155 02:41:06,920 --> 02:41:08,360 AGAIN, CONTINUING ALONG WITH 4156 02:41:08,360 --> 02:41:09,680 PREVENTION AND TREATMENT IN 4157 02:41:09,680 --> 02:41:11,720 PREGNANT WOMEN AND CHILDREN, 4158 02:41:11,720 --> 02:41:17,480 VERY PLEASED TO SAY THAT THE MTN 4159 02:41:17,480 --> 02:41:19,760 ENROLLMENT FOR MTN042 WAS 4160 02:41:19,760 --> 02:41:21,760 COMPLETED FOR ALL THREE COHORTS. 4161 02:41:21,760 --> 02:41:26,400 THIS IS A STUDY LOOKING AT THE 4162 02:41:26,400 --> 02:41:28,040 DAPIVIRINE RING AND ORAL PREP IN 4163 02:41:28,040 --> 02:41:28,800 PREGNANT WOMEN. 4164 02:41:28,800 --> 02:41:35,160 THEY STARTED WITH THE LATEST 4165 02:41:35,160 --> 02:41:36,800 GESTATION, STARTING AT ABOUT 36 4166 02:41:36,800 --> 02:41:38,120 WEEKS ENROLLMENT WITH COHORT 4167 02:41:38,120 --> 02:41:42,560 ONE, AND THEN SEQUENTIALLY MOVED 4168 02:41:42,560 --> 02:41:43,600 FURTHER AND FURTHER BACK TO 4169 02:41:43,600 --> 02:41:47,240 EARLIER STAGES ALL THE WAY TO 12 4170 02:41:47,240 --> 02:41:52,760 WEEKS WITH COHORT THREE. 4171 02:41:52,760 --> 02:41:54,560 SO THE SAFETY INFORMATION FROM 4172 02:41:54,560 --> 02:41:55,720 COHORTS ONE AND TWO WILL BE 4173 02:41:55,720 --> 02:41:58,360 PRESENTED AT CROI NEXT MONTH AND 4174 02:41:58,360 --> 02:42:08,840 FOLLOW-UP OF THE STUDY IS IN 4175 02:42:10,160 --> 02:42:12,680 PROGRESS. 4176 02:42:12,680 --> 02:42:16,760 SO, NOW KIND OF REFOWS FAUX REFN 4177 02:42:16,760 --> 02:42:18,680 WHAT'S COMING NEXT, WHAT DO WE 4178 02:42:18,680 --> 02:42:21,280 SEE AS THE CHALLENGES AND 4179 02:42:21,280 --> 02:42:31,520 OPPORTUNITIES. 4180 02:42:38,560 --> 02:42:39,800 SO SOME OF THIS YOU'VE SEEN 4181 02:42:39,800 --> 02:42:40,080 BEFORE. 4182 02:42:40,080 --> 02:42:42,160 A LITTLE BIT -- CERTAINLY WE 4183 02:42:42,160 --> 02:42:43,360 HAVE MADE PROGRESS AS WE JUST 4184 02:42:43,360 --> 02:42:45,240 TALKED ABOUT. 4185 02:42:45,240 --> 02:42:46,480 BUT WE'RE STILL FACED WITH A 4186 02:42:46,480 --> 02:42:48,680 NUMBER OF CHALLENGES THAT ARE 4187 02:42:48,680 --> 02:42:51,400 EVOLVING AS WE GO ALONG. 4188 02:42:51,400 --> 02:42:54,360 THE EFFECTIVENESS OF ORAL PREP 4189 02:42:54,360 --> 02:42:57,240 AND CABOTEGRAVIR, AS WELL AS 4190 02:42:57,240 --> 02:42:59,440 EVENTUAL AVAILABILITY OF THE 4191 02:42:59,440 --> 02:43:00,880 DAPIVIRINE INTERVAGINAL RING 4192 02:43:00,880 --> 02:43:03,840 WILL DRASTICALLY DECREASE HIV 4193 02:43:03,840 --> 02:43:05,520 INFECTION RATES IN STUDIES, AND 4194 02:43:05,520 --> 02:43:07,040 WE CERTAINLY HOPE EVENTUALLY IN 4195 02:43:07,040 --> 02:43:11,320 THE POPULATION AS A WHOLE, SO 4196 02:43:11,320 --> 02:43:12,560 THEN OTHERS HAVE TALKED A BIT 4197 02:43:12,560 --> 02:43:14,160 ABOUT THIS, YOU KNOW, WHAT ABOUT 4198 02:43:14,160 --> 02:43:18,240 THE RESOURCES TO -- WE KNOW WE 4199 02:43:18,240 --> 02:43:19,920 STILL NEED MORE CHOICES, WE NEED 4200 02:43:19,920 --> 02:43:21,920 MORE PRODUCTS AND MORE 4201 02:43:21,920 --> 02:43:25,160 STRATEGIES TO REALLY OPTIMALLY 4202 02:43:25,160 --> 02:43:29,560 REACH ALL THOSE IN NEED OF HIV 4203 02:43:29,560 --> 02:43:30,360 PREVENTION, BUT TO CONTINUE IN 4204 02:43:30,360 --> 02:43:32,040 THE REALLY TRADITIONAL CLINICAL 4205 02:43:32,040 --> 02:43:33,960 TRIALS THAT THE RESOURCES REALLY 4206 02:43:33,960 --> 02:43:35,880 BECOME PROHIBITIVE WHEN YOU CAN 4207 02:43:35,880 --> 02:43:39,720 GET INCIDENCE RATES AS LOW AS WE 4208 02:43:39,720 --> 02:43:41,000 CAN WITH THESE MODALITIES WE 4209 02:43:41,000 --> 02:43:43,840 ALREADY HAVE. 4210 02:43:43,840 --> 02:43:45,040 SO THERE'S BEEN A LOT OF 4211 02:43:45,040 --> 02:43:46,040 DISCUSSION, THE FORUM FOR 4212 02:43:46,040 --> 02:43:47,240 COLLABORATIVE RESEARCH HAS 4213 02:43:47,240 --> 02:43:50,680 HOSTED AS WELL AS OTHERS, HAVE 4214 02:43:50,680 --> 02:43:51,960 HOSTED, YOU KNOW, WORKING GROUPS 4215 02:43:51,960 --> 02:43:54,720 AND MEETINGS ON WHAT ARE 4216 02:43:54,720 --> 02:43:56,080 ALTERNATIVE POTENTIAL TRIAL 4217 02:43:56,080 --> 02:43:59,920 DESIGNS FOR HIV PREVENTION 4218 02:43:59,920 --> 02:44:01,000 TRIALS THAT WON'T HOPEFULLY TAKE 4219 02:44:01,000 --> 02:44:02,120 AS MANY RESOURCES. 4220 02:44:02,120 --> 02:44:04,320 THERE'S BEEN A FAIR AMOUNT OF 4221 02:44:04,320 --> 02:44:06,640 DISCUSSION IN A RELATIVELY 4222 02:44:06,640 --> 02:44:11,720 RECENT CONSENSUS STATEMENT ON 4223 02:44:11,720 --> 02:44:14,440 THE USE OF COUNTERFACTUALS AND 4224 02:44:14,440 --> 02:44:18,840 HOW RESEARCHERS CAN GO ABOUT 4225 02:44:18,840 --> 02:44:21,840 ESTABLISHING COUNTERFACTUAL HIV 4226 02:44:21,840 --> 02:44:24,240 INCIDENCE IN A COMPARATIVE 4227 02:44:24,240 --> 02:44:26,000 POPULATION, EITHER 4228 02:44:26,000 --> 02:44:29,520 CONTEMPORANEOUSLY OR RECENTLY 4229 02:44:29,520 --> 02:44:30,080 CONTEMPORANEOUSLY. 4230 02:44:30,080 --> 02:44:32,680 AND WE KNOW THAT SOME OF OUR 4231 02:44:32,680 --> 02:44:34,000 PARTNERS AND PARTICULARLY OUR 4232 02:44:34,000 --> 02:44:35,920 PHARMA PARTNERS HAVE BEEN USING 4233 02:44:35,920 --> 02:44:38,000 THIS COUNTERFACTUAL METHOD, BUT 4234 02:44:38,000 --> 02:44:40,280 WE PROBABLY NEED TO, AND THERE 4235 02:44:40,280 --> 02:44:42,160 IS CONSIDERATION OF OTHERS, 4236 02:44:42,160 --> 02:44:45,000 STILL PROBABLY FURTHER 4237 02:44:45,000 --> 02:44:46,400 DISCUSSION, I'VE HAD SEVERAL 4238 02:44:46,400 --> 02:44:47,800 PARTNERS COME RECENTLY TO SAY 4239 02:44:47,800 --> 02:44:50,000 THAT WE DEFINITELY NEED TO GET 4240 02:44:50,000 --> 02:44:52,520 TOGETHER AND DISCUSS, YOU KNOW, 4241 02:44:52,520 --> 02:44:53,720 KIND OF THE -- A BIT FURTHER 4242 02:44:53,720 --> 02:44:56,440 ABOUT THE WAY FORWARD HERE, SO 4243 02:44:56,440 --> 02:44:57,600 THAT IS A GREAT PROBLEM TO HAVE 4244 02:44:57,600 --> 02:44:59,880 ON THE ONE HAND, BECAUSE WE HAVE 4245 02:44:59,880 --> 02:45:02,400 VERY EFFECTIVE METHODS, BUT A 4246 02:45:02,400 --> 02:45:04,200 PROBLEM NONETHELESS THAT WE'LL 4247 02:45:04,200 --> 02:45:05,520 NEED TO WRESTLE WITH. 4248 02:45:05,520 --> 02:45:08,160 IT WAS BROUGHT UP EARLIER, 4249 02:45:08,160 --> 02:45:09,920 COST-EFFECTIVENESS OF NEW HIV 4250 02:45:09,920 --> 02:45:12,160 PREVENTION PRODUCTS IS OBVIOUSLY 4251 02:45:12,160 --> 02:45:14,160 CRUCIAL. 4252 02:45:14,160 --> 02:45:17,760 I KNOW THAT KEN AND HIS GROUP 4253 02:45:17,760 --> 02:45:19,960 SHORTLY AFTER THE LAST ARAC, YOU 4254 02:45:19,960 --> 02:45:22,520 KNOW, WROTE A PAPER ABOUT THE 4255 02:45:22,520 --> 02:45:26,560 ISSUES WITH COST-EFFECTIVENESS 4256 02:45:26,560 --> 02:45:30,440 AND THE COST IS QUITE HIGH, WITH 4257 02:45:30,440 --> 02:45:30,920 CABOTEGRAVIR LA. 4258 02:45:30,920 --> 02:45:31,960 I THINK THAT'S SOMETHING WE'RE 4259 02:45:31,960 --> 02:45:33,680 ALL VERY MUCH AWARE OF, AND AS I 4260 02:45:33,680 --> 02:45:37,800 THINK YOU ALL KNOW, VIIV HAD 4261 02:45:37,800 --> 02:45:40,760 SIGNED AGREEMENTS WITH THE 4262 02:45:40,760 --> 02:45:42,080 MEDICINE'S PATENT POOL TO REALLY 4263 02:45:42,080 --> 02:45:44,760 TRY VERY HARD TO TRY TO BRING 4264 02:45:44,760 --> 02:45:50,880 THOSE COSTS DOWN. 4265 02:45:50,880 --> 02:45:54,600 THE CO-CHAIRS OF HPTN804 ALONG 4266 02:45:54,600 --> 02:45:57,400 WITH OTHER COLLEAGUES IN SOUTH 4267 02:45:57,400 --> 02:45:59,840 AFRICA VERY RECENTLY WROTE 4268 02:45:59,840 --> 02:46:02,960 SPECIFICALLY ABOUT THE SCENARIO 4269 02:46:02,960 --> 02:46:06,840 FOR SOUTH AFRICA AND GIVEN 4270 02:46:06,840 --> 02:46:08,600 POTENTIALLY NEW PREFERENCE FOR 4271 02:46:08,600 --> 02:46:10,120 CAB-LA AND, THEREFORE, MORE 4272 02:46:10,120 --> 02:46:11,400 DEMAND, YOU KNOW, THEY REALLY 4273 02:46:11,400 --> 02:46:13,120 WENT INTO WHAT THE PRICES WOULD 4274 02:46:13,120 --> 02:46:16,080 NEED TO COME DOWN TO. 4275 02:46:16,080 --> 02:46:17,600 THE QUESTION WAS ASKED ABOUT, DO 4276 02:46:17,600 --> 02:46:19,480 WE CONSIDER THESE THINGS, 4277 02:46:19,480 --> 02:46:22,240 CERTAINLY WE DO AS WE'RE 4278 02:46:22,240 --> 02:46:25,120 THINKING ABOUT NEW PREVENTION 4279 02:46:25,120 --> 02:46:27,600 MODALITIES COMING ALONG. 4280 02:46:27,600 --> 02:46:29,000 RECOGNIZING THAT ONCE THEY'RE 4281 02:46:29,000 --> 02:46:31,280 PROVEN EFFECTIVE AND DEMAND IS 4282 02:46:31,280 --> 02:46:32,760 CREATED, THAT THERE'S A LOT OF 4283 02:46:32,760 --> 02:46:34,640 PRESSURE TO DECREASE COSTS EVEN 4284 02:46:34,640 --> 02:46:37,680 IF IT WAS HIGHER TO BEGIN WITH, 4285 02:46:37,680 --> 02:46:38,880 AND SOMETHING THAT WE'RE VERY 4286 02:46:38,880 --> 02:46:41,480 MUCH -- THAT WE VERY MUCH 4287 02:46:41,480 --> 02:46:42,960 DISCUSS WITH THE PHARMA 4288 02:46:42,960 --> 02:46:45,000 COMPANIES AND OTHER PARTNERS AS 4289 02:46:45,000 --> 02:46:46,920 WE'RE CONSIDERING TO START THESE 4290 02:46:46,920 --> 02:46:48,280 STUDIES THAT THAT IS GOING TO 4291 02:46:48,280 --> 02:46:51,920 NEED TO HAPPEN, YOU KNOW, AS 4292 02:46:51,920 --> 02:46:53,720 DIANA POINTED OUT, IT'S NOT 4293 02:46:53,720 --> 02:46:55,080 SOMETHING THAT WE CAN MANDATE AT 4294 02:46:55,080 --> 02:46:57,880 THIS POINT, BUT IT'S CLEARLY 4295 02:46:57,880 --> 02:47:00,280 VERY IMPORTANT AND ON EVERYONE'S 4296 02:47:00,280 --> 02:47:01,280 MIND. 4297 02:47:01,280 --> 02:47:02,680 WE ALSO NEED PRODUCTS, AND I 4298 02:47:02,680 --> 02:47:05,040 THINK DIANA DID A REALLY NICE 4299 02:47:05,040 --> 02:47:08,760 JOB OF TALKING ABOUT LENACAPAVIR 4300 02:47:08,760 --> 02:47:10,760 AND THE POSSIBILITIES THERE. 4301 02:47:10,760 --> 02:47:13,680 WE ARE WORKING, WE ARE STARTING 4302 02:47:13,680 --> 02:47:17,080 TO WORK WITHIN THE HPTN WITH 4303 02:47:17,080 --> 02:47:19,320 GILEAD ON A COUPLE OF -- GILEAD 4304 02:47:19,320 --> 02:47:21,880 IS DOING THE TWO LARGE EFFICACY 4305 02:47:21,880 --> 02:47:24,920 STUDIES, ONE IN MEN, ONE IN 4306 02:47:24,920 --> 02:47:29,960 WOMEN, FOR LENACAPAVIR FOR 4307 02:47:29,960 --> 02:47:30,760 PREVENTION, BUT WE'RE LOOKING ON 4308 02:47:30,760 --> 02:47:32,000 SOME FOCUSED POPULATION STUDIES 4309 02:47:32,000 --> 02:47:33,800 THAT ARE GOING TO BE REALLY 4310 02:47:33,800 --> 02:47:34,720 IMPORTANT MOVING FORWARD. 4311 02:47:34,720 --> 02:47:36,400 SO LONGER ACTING DURATION IS 4312 02:47:36,400 --> 02:47:38,680 SOMETHING THAT WE CONTINUE TO 4313 02:47:38,680 --> 02:47:39,880 WORK ON. 4314 02:47:39,880 --> 02:47:41,920 AND THEN THE REGULATORY 4315 02:47:41,920 --> 02:47:44,240 CHALLENGES, YOU KNOW, WE HAVE 4316 02:47:44,240 --> 02:47:44,960 MULTIPURPOSE PREVENTION 4317 02:47:44,960 --> 02:47:49,480 TECHNOLOGIES AS ONE OF OUR AREAS 4318 02:47:49,480 --> 02:47:51,040 OF FOCUS. 4319 02:47:51,040 --> 02:47:52,120 THOSE ARE A GREAT THING, AND 4320 02:47:52,120 --> 02:47:57,720 HOPEFULLY THAT WILL PROVE TO BE 4321 02:47:57,720 --> 02:47:58,920 SO, BUT THERE ARE SOME 4322 02:47:58,920 --> 02:48:00,760 CHALLENGES, AND WORKING WITH 4323 02:48:00,760 --> 02:48:02,800 REGULATORS IS GOING TO BE VERY 4324 02:48:02,800 --> 02:48:03,080 CRITICAL. 4325 02:48:03,080 --> 02:48:04,600 THE FDA RECENTLY PUT OUT SOME 4326 02:48:04,600 --> 02:48:09,840 GUIDANCE IN THE LAST YEAR ON 4327 02:48:09,840 --> 02:48:11,400 MPTs AND STATING THAT OFTEN 4328 02:48:11,400 --> 02:48:14,320 YOU HAVE TWO OR MORE APIs AND 4329 02:48:14,320 --> 02:48:17,760 WHERE DO YOU GO, AND THEY MAY BE 4330 02:48:17,760 --> 02:48:20,440 WITHIN DIFFERENT GROUPS AT FDA, 4331 02:48:20,440 --> 02:48:22,520 AND THEY SAID OKAY, YOU REALLY 4332 02:48:22,520 --> 02:48:27,040 NEED TO CONSULT EARLY WITH THE 4333 02:48:27,040 --> 02:48:28,360 PRODUCT THAT IS CONSIDERED THE 4334 02:48:28,360 --> 02:48:29,680 PRIMARY MODE OF ACTION FOR 4335 02:48:29,680 --> 02:48:31,360 WHATEVER IT IS YOU'RE 4336 02:48:31,360 --> 02:48:32,360 CONSIDERING STUDYING, AND I 4337 02:48:32,360 --> 02:48:35,400 THINK IN OUR ROLE, YOU KNOW, AS 4338 02:48:35,400 --> 02:48:38,800 NIH AND A SISTER AGENCY OF FDA, 4339 02:48:38,800 --> 02:48:39,840 THAT THAT WILL BE REALLY 4340 02:48:39,840 --> 02:48:41,200 IMPORTANT AS WE MOVE FORWARD FOR 4341 02:48:41,200 --> 02:48:51,720 US TO MAKE THOSE CONTACTS EARLY. 4342 02:49:02,720 --> 02:49:05,320 SO AGAIN, STILL CONSIDERING THE 4343 02:49:05,320 --> 02:49:08,160 CHALLENGES FOR THE FUTURE OF HIV 4344 02:49:08,160 --> 02:49:11,920 PREVENTION RESEARCH, WE NEED TO 4345 02:49:11,920 --> 02:49:13,000 CONTINUE, WE'VE BEEN WORKING, 4346 02:49:13,000 --> 02:49:14,640 MANY OF US ALL TOGETHER, FOR A 4347 02:49:14,640 --> 02:49:19,400 LONG TIME TO REALLY UND UNDERSTD 4348 02:49:19,400 --> 02:49:22,240 HOW TO INDUCE DESIRE, IF YOU 4349 02:49:22,240 --> 02:49:23,560 WILL, FOR HIV PREVENTION AND 4350 02:49:23,560 --> 02:49:27,560 THEN FOR SPECIFIC HIV PREVENTION 4351 02:49:27,560 --> 02:49:28,320 PRODUCTS, THAT'S STILL A 4352 02:49:28,320 --> 02:49:31,080 REQUIREMENT, IT HASN'T CHANGED. 4353 02:49:31,080 --> 02:49:32,320 WE'VE MADE SOME PROGRESS BUT 4354 02:49:32,320 --> 02:49:34,080 WE'VE GOT TO CONTINUE IN THAT 4355 02:49:34,080 --> 02:49:34,400 VEIN. 4356 02:49:34,400 --> 02:49:36,560 AND THEN AS I SAID EARLIER ON IN 4357 02:49:36,560 --> 02:49:41,120 THINKING ABOUT CHOICE, CHOICE IS 4358 02:49:41,120 --> 02:49:42,440 NEEDED FOR KEY POPULATIONS AND 4359 02:49:42,440 --> 02:49:46,480 HOW TO BEST ENGAGE THESE 4360 02:49:46,480 --> 02:49:47,600 POPULATIONS FOR HIV PREVENTION. 4361 02:49:47,600 --> 02:49:49,680 IT'S BEEN CLEAR TO US THAT EARLY 4362 02:49:49,680 --> 02:49:52,440 INTEGRATION OF BEHAVIORAL AND 4363 02:49:52,440 --> 02:49:54,040 SOCIAL SCIENCE INTO OUR STUDIES 4364 02:49:54,040 --> 02:49:56,680 IS VERY IMPORTANT, AND THEN 4365 02:49:56,680 --> 02:50:00,040 COMMUNITY ENGAGEMENT AND REALLY 4366 02:50:00,040 --> 02:50:02,240 FOLLOWING THE GOOD PARTICIPATORY 4367 02:50:02,240 --> 02:50:03,960 PRACTICES, IT IS A MUST. 4368 02:50:03,960 --> 02:50:07,120 IN ORDER TO COME TOGETHER AS A 4369 02:50:07,120 --> 02:50:11,440 GROUP AND BE ABLE TO HAVE 4370 02:50:11,440 --> 02:50:12,360 THESE -- IMPROVE OUR 4371 02:50:12,360 --> 02:50:13,360 UNDERSTANDING AND MOVE PRODUCTS 4372 02:50:13,360 --> 02:50:13,840 FORWARD. 4373 02:50:13,840 --> 02:50:16,880 AND THEN IN REALLY DOING THIS 4374 02:50:16,880 --> 02:50:18,200 REQUIRES A LOT OF INNOVATION, 4375 02:50:18,200 --> 02:50:20,000 AND IT CERTAINLY -- AND THIS IS 4376 02:50:20,000 --> 02:50:21,760 A THEME YOU CAN HEAR, IT 4377 02:50:21,760 --> 02:50:23,040 REQUIRES PARTNERSHIP. 4378 02:50:23,040 --> 02:50:25,280 WE'VE GOT TO MAINTAIN OUR 4379 02:50:25,280 --> 02:50:26,400 CURRENT PARTNERSHIPS OF WHICH WE 4380 02:50:26,400 --> 02:50:29,120 HAVE MANY, BUT PROBABLY DEVELOP 4381 02:50:29,120 --> 02:50:30,880 NEW ONES AND THIS WAS SOMETHING 4382 02:50:30,880 --> 02:50:33,680 THAT WE WERE TALKING IN ANOTHER 4383 02:50:33,680 --> 02:50:35,080 MEETING RECENTLY ABOUT, YOU 4384 02:50:35,080 --> 02:50:41,080 KNOW, HOW DO WE AT NIAID FILL 4385 02:50:41,080 --> 02:50:42,120 SPECIFIC SCIENTIFIC GAPS THAT 4386 02:50:42,120 --> 02:50:47,160 ARE WITHIN OUR MISSION HERE IN 4387 02:50:47,160 --> 02:50:48,600 THE IMPLEMENTATION SPACE BY 4388 02:50:48,600 --> 02:50:50,000 WORKING WITH PARTNERS, AND 4389 02:50:50,000 --> 02:50:53,400 SOMETIMES THAT MIGHT BE A 4390 02:50:53,400 --> 02:50:54,240 RELATIVELY NARROW SLIVER. 4391 02:50:54,240 --> 02:50:55,560 SOMETIMES IT MIGHT BE BROADER. 4392 02:50:55,560 --> 02:50:59,880 BUT REALLY FOCUSING ON HOW TO BE 4393 02:50:59,880 --> 02:51:00,840 MORE INNOVATIVE IN THIS SPACE IS 4394 02:51:00,840 --> 02:51:08,760 GOING TO BE IMPORTANT. 4395 02:51:08,760 --> 02:51:09,440 SO OUR OPPORTUNITIES. 4396 02:51:09,440 --> 02:51:11,680 WE HAVE THE HPTN, WE HAVE A 4397 02:51:11,680 --> 02:51:13,000 NUMBER OF OTHER MODALITIES BUT 4398 02:51:13,000 --> 02:51:15,960 JUST TO FOCUS A MOMENT ON THE 4399 02:51:15,960 --> 02:51:18,440 CLINICAL TESTING AREA 4400 02:51:18,440 --> 02:51:21,160 OPPORTUNITIES, THE HPTN-SPECIFIC 4401 02:51:21,160 --> 02:51:24,800 AIMS ARE DEVELOPMENT OF NOVEL 4402 02:51:24,800 --> 02:51:26,280 ARV-BASED PREVENTION METHODS AND 4403 02:51:26,280 --> 02:51:28,320 DELIVERY SYSTEMS, AND AS I SAID 4404 02:51:28,320 --> 02:51:30,960 EARLIER, THE FOCUS IS ON 4405 02:51:30,960 --> 02:51:33,840 OPTIMIZING AND LONGER DURATION 4406 02:51:33,840 --> 02:51:35,720 ANTIRETROVIRALS FOR PREVENTION. 4407 02:51:35,720 --> 02:51:37,800 THEN FOCUSING ON THE 4408 02:51:37,800 --> 02:51:39,360 MULTIPURPOSE PREVENTION 4409 02:51:39,360 --> 02:51:41,160 TECHNOLOGIES, AND THEN THE 4410 02:51:41,160 --> 02:51:43,960 INTEGRATED BIOMEDICAL AND 4411 02:51:43,960 --> 02:51:45,000 SOCIOBEHAVIORAL PREVENTION 4412 02:51:45,000 --> 02:51:45,480 STUDIES. 4413 02:51:45,480 --> 02:51:49,600 THESE STUDIES ARE OFTEN LARGE. 4414 02:51:49,600 --> 02:51:50,160 THEY'RE QUITE COMPLEX. 4415 02:51:50,160 --> 02:51:51,880 WE HAVE MANY LESSONS LEARNED 4416 02:51:51,880 --> 02:51:52,160 ALREADY. 4417 02:51:52,160 --> 02:51:53,280 IT'S OKAY, YOU CAN STAY ON THIS 4418 02:51:53,280 --> 02:51:53,600 SLIDE. 4419 02:51:53,600 --> 02:51:58,880 WE HAVE MANY LESSONS LEARNED 4420 02:51:58,880 --> 02:52:00,160 ALREADY, AND WE'RE TRYING TO PUT 4421 02:52:00,160 --> 02:52:02,080 THOSE INTO ACTION AS WE THINK 4422 02:52:02,080 --> 02:52:03,080 ABOUT INTEGRATED STRATEGIES. 4423 02:52:03,080 --> 02:52:06,200 NOW CHANGING GEARS A BIT HERE, 4424 02:52:06,200 --> 02:52:06,920 THINKING ABOUT THE CHALLENGES 4425 02:52:06,920 --> 02:52:08,920 FOR THE FUTURE OF MATERNAL AND 4426 02:52:08,920 --> 02:52:12,160 CHILD RESEARCH IN OUR AREAS, 4427 02:52:12,160 --> 02:52:13,560 REALLY AS I'VE SAID IN THE 4428 02:52:13,560 --> 02:52:15,120 BEGINNING WHEN WE WERE TALKING 4429 02:52:15,120 --> 02:52:16,680 ABOUT THE "NEW YORK TIMES" 4430 02:52:16,680 --> 02:52:18,760 ARTICLE, OUR ROLE REALLY IS 4431 02:52:18,760 --> 02:52:21,320 OPTIMIZING THE PRODUCTS, 4432 02:52:21,320 --> 02:52:23,800 OPTIMIZING MATERNAL AND CHILD 4433 02:52:23,800 --> 02:52:28,000 ANTIRETROVIRAL THERAPY AND TB 4434 02:52:28,000 --> 02:52:28,400 REGIMENS AS WELL. 4435 02:52:28,400 --> 02:52:30,320 YOU HEARD ME TALKING ABOUT SOME 4436 02:52:30,320 --> 02:52:32,400 OF THE ACCOMPLISHMENTS STARTING 4437 02:52:32,400 --> 02:52:34,480 INTO THIS AREA OF IMPROVING THE 4438 02:52:34,480 --> 02:52:36,280 CHILD FRIENDLY FORMULATIONS, 4439 02:52:36,280 --> 02:52:39,280 BOTH FOR HIV AND TB. 4440 02:52:39,280 --> 02:52:40,640 WE'VE GOT TO CONTINUE TO 4441 02:52:40,640 --> 02:52:42,800 STRENGTHEN OUR ENGAGEMENT. 4442 02:52:42,800 --> 02:52:47,200 THAT WORK CAN ONLY BE DONE 4443 02:52:47,200 --> 02:52:50,480 REALLY WITH GAP F, THE INOWE VAI 4444 02:52:50,480 --> 02:52:52,520 TER PHARMA COMPANIES AND 4445 02:52:52,520 --> 02:52:53,920 GENERICS AND WE TRIED TO LAY THE 4446 02:52:53,920 --> 02:52:54,560 GROUNDWORK FOR THAT BUT THAT 4447 02:52:54,560 --> 02:52:55,720 WILL NEED TO CONTINUE. 4448 02:52:55,720 --> 02:52:58,160 THEN WE'VE GOT TO CONTINUE 4449 02:52:58,160 --> 02:52:59,360 SUPPORTING IMPROVED TB 4450 02:52:59,360 --> 02:53:01,200 DIAGNOSTICS IN CHILDREN IN ORDER 4451 02:53:01,200 --> 02:53:11,600 TO ENABLE TB TREATMENT. 4452 02:53:13,840 --> 02:53:15,200 WE TALKED ABOUT INCLUDING 4453 02:53:15,200 --> 02:53:17,040 PREGNANT AND LACTATING WOMEN IN 4454 02:53:17,040 --> 02:53:18,240 STUDIES EARLIER IN THE PIPELINE. 4455 02:53:18,240 --> 02:53:19,960 THIS IS REALLY PARAMOUNT, 4456 02:53:19,960 --> 02:53:22,480 ENDORSED BY OUR PRGLAC GROUP, BY 4457 02:53:22,480 --> 02:53:23,640 WHO AND OTHERS. 4458 02:53:23,640 --> 02:53:26,920 WE'VE GOT TO DO THESE EARLY -- 4459 02:53:26,920 --> 02:53:30,880 THESE EARLIER FERTILITY AND 4460 02:53:30,880 --> 02:53:34,160 EARLY EMBRYONIC DEVELOPMENT 4461 02:53:34,160 --> 02:53:36,840 STUDIES, AND POSTNATAL STUDIES 4462 02:53:36,840 --> 02:53:38,720 ALSO, SO REALLY THOSE 4463 02:53:38,720 --> 02:53:40,120 DEVELOPMENTMEN TALL STUDIES NEED 4464 02:53:40,120 --> 02:53:44,720 TO BE DONE, THE PRE-CLINICAL 4465 02:53:44,720 --> 02:53:46,520 STUDIES EARLIER, SO THAT WE CAN 4466 02:53:46,520 --> 02:53:49,680 HAVE ENOUGH INFORMATION TO GET 4467 02:53:49,680 --> 02:53:50,880 PREGNANT WOMEN AND LACTATING 4468 02:53:50,880 --> 02:53:55,640 WOMEN INTO STUDIES INTO THE 4469 02:53:55,640 --> 02:53:56,600 CLINICAL TESTING EARLIER. 4470 02:53:56,600 --> 02:53:57,840 TO DO THAT, THOUGH, REQUIRES 4471 02:53:57,840 --> 02:54:01,320 MUCH EARLIER ENGAGEMENT AND 4472 02:54:01,320 --> 02:54:02,800 TRANSPARENCY WITH PHARMA. 4473 02:54:02,800 --> 02:54:06,600 THAT IS SOMETHING THAT HAS BEEN 4474 02:54:06,600 --> 02:54:09,600 A BIT OF A CHALLENGE, IS 4475 02:54:09,600 --> 02:54:11,760 UNDERSTANDING WHAT THEIR PLANS 4476 02:54:11,760 --> 02:54:13,480 ARE EARLY, HOW THEY INTEND TO 4477 02:54:13,480 --> 02:54:15,680 FOCUS, WHAT FORMULATIONS, WHAT 4478 02:54:15,680 --> 02:54:17,640 WORK THEY'VE DONE ALREADY, OR 4479 02:54:17,640 --> 02:54:21,000 PLAN TO DO, AND WHERE WE CAN 4480 02:54:21,000 --> 02:54:23,080 COME IN WITH OUR RESOURCES AND 4481 02:54:23,080 --> 02:54:26,280 PRIORITIZE THOSE RESOURCES AS 4482 02:54:26,280 --> 02:54:27,760 EARLY AS POSSIBLE AND BE EE 4483 02:54:27,760 --> 02:54:30,480 FISH. 4484 02:54:30,480 --> 02:54:31,040 EFFICIENT. 4485 02:54:31,040 --> 02:54:32,400 AND THEN INCLUSION OF 4486 02:54:32,400 --> 02:54:32,720 ADOLESCENTS. 4487 02:54:32,720 --> 02:54:34,520 I SAW SOME DISCUSSION OF THIS IN 4488 02:54:34,520 --> 02:54:35,720 THE CHAT. 4489 02:54:35,720 --> 02:54:38,520 AND CHILDREN EARLIER IN PRODUCT 4490 02:54:38,520 --> 02:54:39,800 DEVELOPMENT, AGAIN, A SIMILAR 4491 02:54:39,800 --> 02:54:43,200 THING TO PREGNANT AND LACTATING 4492 02:54:43,200 --> 02:54:43,440 WOMEN. 4493 02:54:43,440 --> 02:54:44,840 WE REALLY NEED TO BE COGNIZANT 4494 02:54:44,840 --> 02:54:46,200 OF NEEDING TO DO THIS. 4495 02:54:46,200 --> 02:54:50,200 WE NEED TO BE SENSITIVE TO THEIR 4496 02:54:50,200 --> 02:54:51,280 NEEDS, BOTH CHILDREN AND 4497 02:54:51,280 --> 02:54:51,600 ADOLESCENTS. 4498 02:54:51,600 --> 02:54:54,240 I WOULD SAY IT'S PROBABLY PRETTY 4499 02:54:54,240 --> 02:54:56,680 SPECIFIC FOR HOW WE PLAN TRIAL 4500 02:54:56,680 --> 02:54:59,360 LOGISTICS, HOW WE OPERATIONALIZE 4501 02:54:59,360 --> 02:55:01,600 STUDIES FOR ADOLESCENTS IS 4502 02:55:01,600 --> 02:55:03,240 REALLY IMPORTANT, AND YOU KNOW, 4503 02:55:03,240 --> 02:55:05,560 SOMETHING THAT DID COME UP AT 4504 02:55:05,560 --> 02:55:07,160 THE ROME MEETING AND HAS COME UP 4505 02:55:07,160 --> 02:55:09,000 A NUMBER OF TIMES, AND I THINK 4506 02:55:09,000 --> 02:55:12,160 THAT WE'RE DOING VERY WELL IS, 4507 02:55:12,160 --> 02:55:14,520 AS STUDIES THAT ARE PLANNED FOR 4508 02:55:14,520 --> 02:55:16,920 ADULTS COME ALONG FOR OUR 4509 02:55:16,920 --> 02:55:18,600 SCIENTIFIC REVIEW, ALWAYS ASKING 4510 02:55:18,600 --> 02:55:20,840 THIS FOAS STUDIES APPLY TO 4511 02:55:20,840 --> 02:55:24,000 CHILDREN OR ADOLESCENTS, AND IF 4512 02:55:24,000 --> 02:55:26,920 SO, ARE THERE REASONS -- YOU 4513 02:55:26,920 --> 02:55:28,240 KNOW, THE PRODUCT OR THE 4514 02:55:28,240 --> 02:55:29,840 STRATEGY MAY APPLY, ARE THERE 4515 02:55:29,840 --> 02:55:32,480 REASONS AT THIS STAGE THAT WE 4516 02:55:32,480 --> 02:55:35,680 COULDN'T INCLUDE AND NEED TO BE 4517 02:55:35,680 --> 02:55:37,760 VERY CLEAR ABOUT THAT, THAT THAT 4518 02:55:37,760 --> 02:55:40,200 IS THE CASE, AND IF NOT, THEN WE 4519 02:55:40,200 --> 02:55:42,280 REALLY NEED TO CONSIDER 4520 02:55:42,280 --> 02:55:43,600 INCLUSION EARLIER. 4521 02:55:43,600 --> 02:55:45,520 AND THEN OF COURSE AS WE TALKED 4522 02:55:45,520 --> 02:55:46,520 ABOUT, YOU KNOW, ONE OF OUR 4523 02:55:46,520 --> 02:55:49,040 MAJOR TASKS ARE TO CONTINUE TO 4524 02:55:49,040 --> 02:55:52,240 WORK ON HIV-FREE REMISSION IN 4525 02:55:52,240 --> 02:55:54,600 CHILDREN, WHICH WE WILL DO, AND 4526 02:55:54,600 --> 02:55:56,000 BACK TO ADOLESCENTS FOR A 4527 02:55:56,000 --> 02:55:57,840 MOMENT, I MEAN, I THINK IN SOME 4528 02:55:57,840 --> 02:55:59,840 WAYS, WE'VE DONE A PRETTY GOOD 4529 02:55:59,840 --> 02:56:02,280 JOB IN THE AREA OF TREATMENT. 4530 02:56:02,280 --> 02:56:04,000 WE'VE GOTTEN A NUMBER OF 4531 02:56:04,000 --> 02:56:05,600 APPROVALS AS YOU SAW EARLIER, 4532 02:56:05,600 --> 02:56:08,640 YOU KNOW, UNDER THE 4533 02:56:08,640 --> 02:56:09,600 ACCOMPLISHMENT SECTIONS AND EVEN 4534 02:56:09,600 --> 02:56:11,600 PAST APPROVALS FOR 4535 02:56:11,600 --> 02:56:13,840 ANTIRETROVIRAL TREATMENT, AND 4536 02:56:13,840 --> 02:56:16,160 OPTIMIZING THAT IN ADOLESCENTS. 4537 02:56:16,160 --> 02:56:22,120 WE'VE COMPLETED HPTN08301 AND 4538 02:56:22,120 --> 02:56:25,720 401 WHICH WERE THE ADOLESCENT 4539 02:56:25,720 --> 02:56:27,880 FOCUSED CABOTEGRAVIR STUDIES FOR 4540 02:56:27,880 --> 02:56:29,480 PREVENTION AND THE ATN HAS DONE 4541 02:56:29,480 --> 02:56:31,920 A LOT OF WORK IN THE AREA OF 4542 02:56:31,920 --> 02:56:33,080 ADOLESCENCE DOMESTICALLY 4543 02:56:33,080 --> 02:56:33,320 FOCUSED. 4544 02:56:33,320 --> 02:56:35,240 FOR US IN THAT SPACE, WE REALLY 4545 02:56:35,240 --> 02:56:38,440 NEED TO CONTINUE TO THINK ABOUT 4546 02:56:38,440 --> 02:56:41,400 NIAID AND OUR PARTNERS MISSION 4547 02:56:41,400 --> 02:56:44,000 OF OPTIMIZING THE PRODUCTS AND 4548 02:56:44,000 --> 02:56:45,120 STRATEGIES, AND THEN WORKING 4549 02:56:45,120 --> 02:56:48,440 WITH PARTNERS ON THE 4550 02:56:48,440 --> 02:56:49,720 IMPLEMENTATION ISSUE SURROUNDING 4551 02:56:49,720 --> 02:56:51,280 ADOLESCENTS. 4552 02:56:51,280 --> 02:56:53,160 SO WHAT ARE OUR OPPORTUNITIES? 4553 02:56:53,160 --> 02:56:56,000 WE HAVE THE IMPACT NETWORK IN 4554 02:56:56,000 --> 02:56:57,200 THE CLINICAL AREA, AND THEIR 4555 02:56:57,200 --> 02:56:59,600 SPECIFIC AIMS ARE NOVEL AND 4556 02:56:59,600 --> 02:57:01,680 DURABLE TREATMENT INTERVENTIONS 4557 02:57:01,680 --> 02:57:06,040 FOR HIV, AND THEN ALSO FOR TB 4558 02:57:06,040 --> 02:57:06,880 PREVENTION AND TREATMENT. 4559 02:57:06,880 --> 02:57:09,600 THEN OTHER COMPLICATIONS AND 4560 02:57:09,600 --> 02:57:11,760 COINFECTIONS, AS WELL AS 4561 02:57:11,760 --> 02:57:17,480 ART-FREE REMISSION. 4562 02:57:17,480 --> 02:57:21,800 WE ALSO HAVE THE RAPPS CONTRACT 4563 02:57:21,800 --> 02:57:22,560 HERE. 4564 02:57:22,560 --> 02:57:23,840 THIS IS -- I'VE TALKED ABOUT IT 4565 02:57:23,840 --> 02:57:25,800 SEVERAL TIMES, BUT YOU SEE DOWN 4566 02:57:25,800 --> 02:57:29,960 IN THE BLUE KIND OF SQUARES, 4567 02:57:29,960 --> 02:57:31,200 RECTANGLES BELOW, THAT THERE ARE 4568 02:57:31,200 --> 02:57:34,800 FIVE MAJOR AREAS THAT THE RAPPS 4569 02:57:34,800 --> 02:57:38,000 CONTRACT TASK AREAS THAT WILL BE 4570 02:57:38,000 --> 02:57:39,720 ABLE TO BE UNDERTAKEN, AND THEN 4571 02:57:39,720 --> 02:57:42,840 YOU CAN SEE, AND I THINK WE NEED 4572 02:57:42,840 --> 02:57:44,840 TO HIT THE -- MAYBE THERE'S 4573 02:57:44,840 --> 02:57:45,600 ANIMATION HERE. 4574 02:57:45,600 --> 02:57:46,080 YES. 4575 02:57:46,080 --> 02:57:47,480 AND IF YOU CAN JUST KEEP 4576 02:57:47,480 --> 02:57:48,640 CLICKING, THERE SHOULD BE ONE 4577 02:57:48,640 --> 02:57:49,880 MORE AFTER THIS. 4578 02:57:49,880 --> 02:57:50,440 SORRY ABOUT THAT. 4579 02:57:50,440 --> 02:57:52,760 I DIDN'T REALIZE THAT HAD BEEN 4580 02:57:52,760 --> 02:57:53,320 TAKEN OUT. 4581 02:57:53,320 --> 02:57:55,520 AND YOU CAN SEE HERE UNDER THESE 4582 02:57:55,520 --> 02:57:59,040 TASK AREAS, THAT -- OKAY, THAT 4583 02:57:59,040 --> 02:58:01,120 WHERE WE COULD BE ABLE TO 4584 02:58:01,120 --> 02:58:02,640 CONTRIBUTE PARTICULARLY TO THE 4585 02:58:02,640 --> 02:58:04,880 PEDIATRIC FORMULATION WORK, 4586 02:58:04,880 --> 02:58:06,800 WHERE WE HAVE THESE 4587 02:58:06,800 --> 02:58:07,320 OPPORTUNITIES. 4588 02:58:07,320 --> 02:58:08,520 I WON'T GO OVER ALL THE 4589 02:58:08,520 --> 02:58:11,600 SPECIFICS OF THOSE. 4590 02:58:11,600 --> 02:58:15,680 NEXT, PLEASE. 4591 02:58:15,680 --> 02:58:17,760 SO WE'RE BACK TO HOW IT ALL FITS 4592 02:58:17,760 --> 02:58:18,640 TOGETHER. 4593 02:58:18,640 --> 02:58:20,080 AGAIN, I'VE EXPLAINED THIS BUT 4594 02:58:20,080 --> 02:58:21,880 JUST TO BRING YOU BACK TO IT ONE 4595 02:58:21,880 --> 02:58:32,040 MORE TIME. 4596 02:58:35,160 --> 02:58:36,760 AGAIN, A REMINDER OF OUR 4597 02:58:36,760 --> 02:58:37,960 PRIORITY, BRING US ALL BACK TO 4598 02:58:37,960 --> 02:58:41,200 WHERE WE STARTED, AND AGAIN, I 4599 02:58:41,200 --> 02:58:45,400 THANK EVERYBODY IN PREVENTION 4600 02:58:45,400 --> 02:58:46,440 SCIENCES PROGRAM ACROSS THE 4601 02:58:46,440 --> 02:58:47,040 DIVISION. 4602 02:58:47,040 --> 02:58:48,640 CARL AND SARAH FOR THEIR 4603 02:58:48,640 --> 02:58:49,640 LEADERSHIP, THIS COMMITTEE, AND 4604 02:58:49,640 --> 02:58:56,880 THANK YOU VERY MUCH. 4605 02:58:56,880 --> 02:59:00,080 >>THANK YOU, DR. ZWERSKI. 4606 02:59:00,080 --> 02:59:02,680 WHAT AN AMBITIOUS AND IMPRESSIVE 4607 02:59:02,680 --> 02:59:04,200 AGENDA, AND REALLY EXCITING 4608 02:59:04,200 --> 02:59:05,640 DEVELOPMENTS OVER THE PAST YEAR 4609 02:59:05,640 --> 02:59:06,720 AND TWO AND THREE, WITH MORE TO 4610 02:59:06,720 --> 02:59:06,920 COME. 4611 02:59:06,920 --> 02:59:07,920 THANK YOU. 4612 02:59:07,920 --> 02:59:13,480 MAYBE WE'LL TAKE ONE QUESTION, 4613 02:59:13,480 --> 02:59:16,640 IF SOMEONE HAS A QUESTION. 4614 02:59:16,640 --> 02:59:20,840 DR. GANDHI? 4615 02:59:20,840 --> 02:59:22,240 >>YOU KNOW, THAT WAS A GREAT 4616 02:59:22,240 --> 02:59:23,240 TALK AND YOU EXPRESSED SOMETHING 4617 02:59:23,240 --> 02:59:24,360 THAT I THINK IS REALLY 4618 02:59:24,360 --> 02:59:25,600 IMPORTANT, WHICH IS -- IS IT THE 4619 02:59:25,600 --> 02:59:26,880 ROLE OF RESEARCH, IS IT THE ROLE 4620 02:59:26,880 --> 02:59:29,280 OF NIAID TO HELP ADDRESS 4621 02:59:29,280 --> 02:59:31,120 DISPARITIES, LIKE IT IS THE CDC, 4622 02:59:31,120 --> 02:59:34,960 LIKE IT IS ALL OF US AS 4623 02:59:34,960 --> 02:59:35,920 CLINICIANS OR TREATERS IN THIS 4624 02:59:35,920 --> 02:59:36,240 ROOM. 4625 02:59:36,240 --> 02:59:37,120 I WOULD ARGUE ALONG WITH YOU 4626 02:59:37,120 --> 02:59:39,760 THAT IT IS OUR GOAL, IT IS ROLE 4627 02:59:39,760 --> 02:59:41,680 IN OUR RESEARCH STUDIES IN TERMS 4628 02:59:41,680 --> 02:59:42,760 OF PARTICIPATORY INCLUSION AND 4629 02:59:42,760 --> 02:59:44,520 IN TERMS OF IMPLEMENTATION AND 4630 02:59:44,520 --> 02:59:45,040 ROLLOUT. 4631 02:59:45,040 --> 02:59:46,480 SO WE'RE AT A POINT WHERE I 4632 02:59:46,480 --> 02:59:49,200 THINK IT HAS TO BE EXPLICITLY 4633 02:59:49,200 --> 02:59:50,480 STATED IN NIAID PRIORITIES. 4634 02:59:50,480 --> 02:59:51,400 THANK YOU. 4635 02:59:51,400 --> 02:59:52,840 >>THANK YOU. 4636 02:59:52,840 --> 02:59:54,560 TOTALLY AGREE. 4637 02:59:54,560 --> 02:59:55,840 >>YES. 4638 02:59:55,840 --> 02:59:58,320 LAST QUESTION, DR. ABRAMS. 4639 02:59:58,320 --> 02:59:59,000 >>HI, SHERYL. 4640 02:59:59,000 --> 02:59:59,240 THANKS. 4641 02:59:59,240 --> 03:00:00,960 THAT WAS REALLY FANTASTIC. 4642 03:00:00,960 --> 03:00:03,280 AND I THINK WE'VE BEEN REALLY 4643 03:00:03,280 --> 03:00:07,200 HAPPY TO SEE NIAID EMBRACE THE 4644 03:00:07,200 --> 03:00:10,720 PREGNANCY AND ADOLESCENT AGENDA. 4645 03:00:10,720 --> 03:00:14,120 I DO THINK THAT THE PEDIATRIC 4646 03:00:14,120 --> 03:00:16,480 COMMUNITY HAS PUT FORWARD 4647 03:00:16,480 --> 03:00:18,160 PARTICULARLY FOR ADOLESCENTS NOT 4648 03:00:18,160 --> 03:00:20,520 THAT WE HAVE SEPARATE STUDIES 4649 03:00:20,520 --> 03:00:23,360 BUT THAT THEY BE INCLUDED IN THE 4650 03:00:23,360 --> 03:00:25,320 ADULT STUDIES USING WEIGHT 4651 03:00:25,320 --> 03:00:27,280 RATHER THAN AGE AS A CUTOFF, 4652 03:00:27,280 --> 03:00:29,480 PARTICULARLY AROUND NEW AGENTS. 4653 03:00:29,480 --> 03:00:31,280 AND I DON'T THINK WE'VE GOTTEN 4654 03:00:31,280 --> 03:00:35,240 TO THAT POINT YET. 4655 03:00:35,240 --> 03:00:37,520 BUT IT WOULD BE FABULOUS AS 4656 03:00:37,520 --> 03:00:40,800 WE'RE ASKING THE QUESTION IN THE 4657 03:00:40,800 --> 03:00:45,440 ADULT TRIALS, THE HPTN TRIALS TO 4658 03:00:45,440 --> 03:00:47,720 SAY IS THERE A REASON THAT YOU 4659 03:00:47,720 --> 03:00:49,800 WOULDN'T INCLUDE -- WOULDN'T USE 4660 03:00:49,800 --> 03:00:50,960 WEIGHT RATHER THAN AGE. 4661 03:00:50,960 --> 03:00:52,080 SO I JUST WANTED TO BRING THAT 4662 03:00:52,080 --> 03:00:52,640 UP. 4663 03:00:52,640 --> 03:00:54,720 >>THANK YOU. 4664 03:00:54,720 --> 03:00:55,800 >>THAT'S A GREAT POINT. 4665 03:00:55,800 --> 03:00:56,640 THANK YOU. 4666 03:00:56,640 --> 03:00:56,880 OKAY. 4667 03:00:56,880 --> 03:00:58,520 WE WILL KEEP MOVING. 4668 03:00:58,520 --> 03:01:02,360 THANK YOU, DR. SWER SKI. 4669 03:01:02,360 --> 03:01:11,080 SWE ZWERSKI.I'M GOING TO TURN F 4670 03:01:11,080 --> 03:01:13,000 CLINICAL SITE OVERSIGHT. 4671 03:01:13,000 --> 03:01:14,960 >>THANK YOU, GOOD AFTERNOON, 4672 03:01:14,960 --> 03:01:15,600 COUNCIL MEMBERS AND COLLEAGUES. 4673 03:01:15,600 --> 03:01:19,360 I HAVE A SLIGHTLY DIFFERENT 4674 03:01:19,360 --> 03:01:21,760 CHARGE FROM MY PROGRAM 4675 03:01:21,760 --> 03:01:23,040 COLLEAGUES AND INSTEAD OF A 4676 03:01:23,040 --> 03:01:24,440 PROGRAM OVERVIEW, I'M GOING TO 4677 03:01:24,440 --> 03:01:28,920 KNOW CFOCUS MY PRESENTATION ON S 4678 03:01:28,920 --> 03:01:31,040 LEARNED FROM THE COVID PANDEMIC 4679 03:01:31,040 --> 03:01:32,760 THAT MAY BE APPLIED TO HIV 4680 03:01:32,760 --> 03:01:33,320 RESEARCH. 4681 03:01:33,320 --> 03:01:34,840 I ONLY HAVE FOUR SLIDES SO I 4682 03:01:34,840 --> 03:01:36,760 THINK I'LL BE ABLE TO MAKE UP A 4683 03:01:36,760 --> 03:01:39,080 LITTLE BIT OF TIME. 4684 03:01:39,080 --> 03:01:40,800 IMPLEMENTING AND EXECUTING 4685 03:01:40,800 --> 03:01:41,320 CLINICAL TRIALS DURING THE 4686 03:01:41,320 --> 03:01:43,280 HEIGHT OF THE PANDEMIC. 4687 03:01:43,280 --> 03:01:44,920 I'LL BUILD OFF OF WHAT WE'VE 4688 03:01:44,920 --> 03:01:46,520 LEARNED RUNNING A PANDEMIC 4689 03:01:46,520 --> 03:01:48,400 TREATMENT TRIAL, AS WELL AS 4690 03:01:48,400 --> 03:01:50,480 CONTINUING OUR HIV/AIDS NETWORK 4691 03:01:50,480 --> 03:01:51,120 TRIALS. 4692 03:01:51,120 --> 03:01:52,760 AND DISCUSS OPPORTUNITIES TO 4693 03:01:52,760 --> 03:01:55,680 STRENGTHEN OUR HIV/AIDS RESEARCH 4694 03:01:55,680 --> 03:01:56,760 ENTERPRISE, AS WELL AS PREPARE 4695 03:01:56,760 --> 03:01:59,280 FOR UPCOMING PANDEMIC TRIALS. 4696 03:01:59,280 --> 03:02:01,800 SO I'LL SPEAK FIRST TO THE 4697 03:02:01,800 --> 03:02:02,520 OPERATIONAL COMPONENTS WHICH 4698 03:02:02,520 --> 03:02:03,280 WORKED WELL. 4699 03:02:03,280 --> 03:02:04,840 THEN I'LL TALK ABOUT LESSONS 4700 03:02:04,840 --> 03:02:06,360 LEARNED AND I'LL WRAP UP 4701 03:02:06,360 --> 03:02:07,720 SPEAKING TO OPPORTUNITIES THAT 4702 03:02:07,720 --> 03:02:09,040 COULD BE CONSIDERED FOR FUTURE 4703 03:02:09,040 --> 03:02:14,200 TRIALS. 4704 03:02:14,200 --> 03:02:17,480 SO WE ALL KNOW THAT OUR CLINICAL 4705 03:02:17,480 --> 03:02:19,320 RESEARCH SITES EXPERIENCE 4706 03:02:19,320 --> 03:02:20,720 SIGNIFICANT OPERATIONAL 4707 03:02:20,720 --> 03:02:22,280 DISRUPTION DURING THIS TIME. 4708 03:02:22,280 --> 03:02:25,040 THERE WAS TREMENDOUS FEAR AND 4709 03:02:25,040 --> 03:02:26,360 UNCERTAINTY AT THE SITES. 4710 03:02:26,360 --> 03:02:27,920 THEY WERE DEALING WITH LOSS OF 4711 03:02:27,920 --> 03:02:31,320 STAFF, SUPPLY CHAIN DISRUPTION, 4712 03:02:31,320 --> 03:02:32,880 CHANGING OPERATING PROCEDURES, 4713 03:02:32,880 --> 03:02:34,600 ALL WHILE SITES WERE ALSO 4714 03:02:34,600 --> 03:02:36,000 RESPONDING TO THEIR LOCAL 4715 03:02:36,000 --> 03:02:37,200 PANDEMIC. 4716 03:02:37,200 --> 03:02:38,400 AND THERE WERE THINGS THAT 4717 03:02:38,400 --> 03:02:39,920 WORKED WELL DURING THIS TIME. 4718 03:02:39,920 --> 03:02:41,720 FIRST, WE WERE ABLE TO REACH OUT 4719 03:02:41,720 --> 03:02:43,760 TO OUR GLOBAL NETWORK OF 4720 03:02:43,760 --> 03:02:45,280 INVESTIGATORS, AND QUICKLY 4721 03:02:45,280 --> 03:02:46,680 ENGAGE THEM TO FACILITATE 4722 03:02:46,680 --> 03:02:47,880 DEVELOPMENT AND EXECUTION OF 4723 03:02:47,880 --> 03:02:49,720 PROTOCOLS TO MEET THIS EMERGENT 4724 03:02:49,720 --> 03:02:51,360 NEED. 4725 03:02:51,360 --> 03:02:53,120 INVESTIGATORS WERE ABLE TO DRAW 4726 03:02:53,120 --> 03:02:54,640 ON THE INFRASTRUCTURE THAT WE'VE 4727 03:02:54,640 --> 03:02:58,480 JOINTLY BUILT OVER MANY YEARS. 4728 03:02:58,480 --> 03:03:00,680 MANY OF THESE SITES HAVE 4729 03:03:00,680 --> 03:03:01,960 PARTICIPATED IN OUR NETWORK 4730 03:03:01,960 --> 03:03:02,960 ENTERPRISE FOR SEVERAL YEARS AND 4731 03:03:02,960 --> 03:03:04,240 WE'VE MADE JOINT INVESTMENTS IN 4732 03:03:04,240 --> 03:03:05,320 DEVELOPING THE INFRASTRUCTURE, 4733 03:03:05,320 --> 03:03:06,400 INCLUDING THE ENGAGEMENT OF 4734 03:03:06,400 --> 03:03:07,920 COMMUNITY ADVISORY BOARDS WITHIN 4735 03:03:07,920 --> 03:03:09,320 EACH OF OUR CLINICAL RESEARCH 4736 03:03:09,320 --> 03:03:10,800 SITES. 4737 03:03:10,800 --> 03:03:12,920 WE WERE ABLE TO QUICKLY PIVOT TO 4738 03:03:12,920 --> 03:03:14,160 TAKE ADVANTAGE OF THAT 4739 03:03:14,160 --> 03:03:15,880 INFRASTRUCTURE TO SUPPORT OUR 4740 03:03:15,880 --> 03:03:19,120 COVID PRIORITIES. 4741 03:03:19,120 --> 03:03:20,320 WHERE NECESSARY, SOME OF THE 4742 03:03:20,320 --> 03:03:22,320 SITES WERE ABLE TO EXPAND OR 4743 03:03:22,320 --> 03:03:24,280 SHIFT THEIR CURRENT CLINIC 4744 03:03:24,280 --> 03:03:26,000 FOOTPRINT TO ACCOMMODATE BOTH 4745 03:03:26,000 --> 03:03:27,320 COVID AND HIV PATIENTS. 4746 03:03:27,320 --> 03:03:29,080 WE HAD FRAMEWORKS IN PLACE FOR 4747 03:03:29,080 --> 03:03:30,360 SITE EXPANSION AND WE WERE ABLE 4748 03:03:30,360 --> 03:03:33,200 TO APPLY THOSE PROCESSES QUICKLY 4749 03:03:33,200 --> 03:03:35,640 TO FACILITATE CLINIC EXPANSION. 4750 03:03:35,640 --> 03:03:38,040 WE WERE ABLE TO SUPPORT THE USE 4751 03:03:38,040 --> 03:03:39,240 OF MOBILE CLINICS THAT CAME 4752 03:03:39,240 --> 03:03:41,440 FULLY STAFFED WITH RESEARCH 4753 03:03:41,440 --> 03:03:43,080 EXPERIENCE PERSONNEL AT SEVERAL 4754 03:03:43,080 --> 03:03:45,240 SITES TO FACILITATE SEPARATION 4755 03:03:45,240 --> 03:03:46,680 OF COVID PARTICIPANTS FROM OTHER 4756 03:03:46,680 --> 03:03:48,560 RESEARCH PARTICIPANTS. 4757 03:03:48,560 --> 03:03:50,400 AND WHERE POSSIBLE AND 4758 03:03:50,400 --> 03:03:51,800 PRACTICAL, WE WERE ABLE TO USE 4759 03:03:51,800 --> 03:03:53,440 REGIONAL APPROACHES TO 4760 03:03:53,440 --> 03:03:54,760 OPERATIONALIZE STUDIES. 4761 03:03:54,760 --> 03:03:56,880 FOR EXAMPLE, WE USED REGIONAL 4762 03:03:56,880 --> 03:03:59,000 DEPOTS TO SECURE 4763 03:03:59,000 --> 03:03:59,640 NON-INVESTIGATIONAL PRODUCT 4764 03:03:59,640 --> 03:04:00,720 SUPPLIES IN DIFFERENT PARTS OF 4765 03:04:00,720 --> 03:04:02,880 THE WORLD, INCLUDING THE U.S. 4766 03:04:02,880 --> 03:04:05,640 TO SHIP STUDY SUPPLIES TO SITES. 4767 03:04:05,640 --> 03:04:07,000 AND THIS WAS ESPECIALLY 4768 03:04:07,000 --> 03:04:08,880 IMPORTANT BECAUSE OF THE 4769 03:04:08,880 --> 03:04:10,080 CONSTRAINTS IN THE SUPPLY CHAIN. 4770 03:04:10,080 --> 03:04:11,640 WE WERE ABLE TO LEVERAGE 4771 03:04:11,640 --> 03:04:14,160 PURCHASING OF SUPPLIES THAT 4772 03:04:14,160 --> 03:04:16,080 INVESTIGATORS MAY OTHERWISE HAVE 4773 03:04:16,080 --> 03:04:21,200 NOT HAD ACCESS TO. 4774 03:04:21,200 --> 03:04:22,480 AND WE HAVE MANY LESSONS 4775 03:04:22,480 --> 03:04:23,040 LEARNED. 4776 03:04:23,040 --> 03:04:25,240 FIRST, THE NIAID LONG TERM 4777 03:04:25,240 --> 03:04:26,280 INVESTMENT IN OUR SITES ALLOWED 4778 03:04:26,280 --> 03:04:30,240 US TO QUICKLY PIVOT THE SITES. 4779 03:04:30,240 --> 03:04:33,720 TO CONTRIBUTE TO NIAID'S 4780 03:04:33,720 --> 03:04:34,240 EMERGENT PRIORITIES. 4781 03:04:34,240 --> 03:04:35,360 OUR NETWORK SITES WERE ABLE TO 4782 03:04:35,360 --> 03:04:37,320 MOVE QUICKLY TO PARTICIPATE IN 4783 03:04:37,320 --> 03:04:38,680 NIAID SPONSORED COVID RESEARCH 4784 03:04:38,680 --> 03:04:39,840 AND DO SO WITH A HIGH LEVEL OF 4785 03:04:39,840 --> 03:04:40,800 QUALITY. 4786 03:04:40,800 --> 03:04:43,120 THE ROBUST PROCESSES AND 4787 03:04:43,120 --> 03:04:44,600 INFRASTRUCTURE AT THESE NIAID 4788 03:04:44,600 --> 03:04:46,240 SITES HAVE BEEN REFINED OVER 4789 03:04:46,240 --> 03:04:48,160 YEARS, AND RESULT IN HIGH 4790 03:04:48,160 --> 03:04:49,760 QUALITY OUTPUTS AND REGULATORY 4791 03:04:49,760 --> 03:04:52,160 COMPLIANCE. 4792 03:04:52,160 --> 03:04:53,560 AND PROTOCOLS THAT WERE MORE 4793 03:04:53,560 --> 03:04:55,720 COMPLEX FACED MORE CHALLENGES 4794 03:04:55,720 --> 03:04:57,400 WITH COMPLIANCE. 4795 03:04:57,400 --> 03:04:59,120 SIMPLICITY OF PROTOCOL WAS KEY, 4796 03:04:59,120 --> 03:05:02,400 ESPECIALLY WORKING ACROSS MANY 4797 03:05:02,400 --> 03:05:02,720 SITES. 4798 03:05:02,720 --> 03:05:03,920 MANY OF WHICH WE HAD NEVER 4799 03:05:03,920 --> 03:05:04,720 WORKED WITH BEFORE. 4800 03:05:04,720 --> 03:05:07,440 WE LEARNED THAT SIMPLIFYING THE 4801 03:05:07,440 --> 03:05:08,400 PROTOCOL TRANSLATED TO BETTER 4802 03:05:08,400 --> 03:05:08,840 COMPLIANCE. 4803 03:05:08,840 --> 03:05:09,840 THE MORE COMPLEX AND DEMANDING 4804 03:05:09,840 --> 03:05:11,400 THE PROTOCOL, THE HIGHER THE 4805 03:05:11,400 --> 03:05:12,960 TENDENCY FOR QUALITY ISSUES AND 4806 03:05:12,960 --> 03:05:15,440 SITE DROPOUT. 4807 03:05:15,440 --> 03:05:17,520 WE FOUND OUT THAT WHEN WE WERE 4808 03:05:17,520 --> 03:05:19,240 CREATING NEW PROCESSES OR HAD TO 4809 03:05:19,240 --> 03:05:20,960 CREATE NEW LINKAGES, THAT THEY 4810 03:05:20,960 --> 03:05:22,800 TENDED TO PRESENT NEW CHALLENGES 4811 03:05:22,800 --> 03:05:24,360 FOR SITES. 4812 03:05:24,360 --> 03:05:26,720 THESE TOOK TIME AND EFFORT 4813 03:05:26,720 --> 03:05:28,040 DURING A HIGHLY CONSTRAINED TIME 4814 03:05:28,040 --> 03:05:29,200 TO DEVELOP, BUT WE ALSO 4815 03:05:29,200 --> 03:05:30,160 RECOGNIZE THAT THERE MAY BE A 4816 03:05:30,160 --> 03:05:32,120 NEED TO DEVELOP NEW SYSTEMS. 4817 03:05:32,120 --> 03:05:35,120 BUT IF POSSIBLE, USE EXISTING 4818 03:05:35,120 --> 03:05:36,400 WORKFLOWS BECAUSE OF THE 4819 03:05:36,400 --> 03:05:37,840 COMPLEXITY AND EFFORT IN 4820 03:05:37,840 --> 03:05:39,480 CREATING NEW SYSTEMS, AND THE 4821 03:05:39,480 --> 03:05:41,160 CHALLENGES WITH SITE COMPLIANCE 4822 03:05:41,160 --> 03:05:42,920 IMPLEMENTING NEW PROCESSES 4823 03:05:42,920 --> 03:05:44,240 DURING THESE VERY CONSTRAINED 4824 03:05:44,240 --> 03:05:46,560 TIMES. 4825 03:05:46,560 --> 03:05:50,480 WE WERE ALSO CHALLENGED TO 4826 03:05:50,480 --> 03:05:51,600 OPERATIONALIZE OUR PROTOCOLS IN 4827 03:05:51,600 --> 03:05:53,440 A MANNER THAT MINIMIZED 4828 03:05:53,440 --> 03:05:54,440 IN-PERSON INTERACTIONS. 4829 03:05:54,440 --> 03:05:55,920 REMOTE APPROACHES REQUIRE AN 4830 03:05:55,920 --> 03:05:57,120 INVESTMENT IN TECHNOLOGY AND 4831 03:05:57,120 --> 03:05:58,320 TRAINING, AND THESE TOOLS WERE 4832 03:05:58,320 --> 03:05:59,720 NOT NECESSARILY IN PLACE AT THE 4833 03:05:59,720 --> 03:06:01,400 TIME THE PROTOCOLS WERE ROLLED 4834 03:06:01,400 --> 03:06:03,800 OUT, WHICH ALSO CREATED DELAYS 4835 03:06:03,800 --> 03:06:08,480 AND SITE CHALLENGES WITH 4836 03:06:08,480 --> 03:06:09,360 IMPLEMENTATION. 4837 03:06:09,360 --> 03:06:10,800 LASTLY WE LEARNED THE IMPORTANCE 4838 03:06:10,800 --> 03:06:12,760 OF HAVING CLEAR, WELL THOUGHT 4839 03:06:12,760 --> 03:06:14,080 THROUGH IMPLEMENTATION PLANS. 4840 03:06:14,080 --> 03:06:15,640 SITES WERE UNDER EXTRAORDINARY 4841 03:06:15,640 --> 03:06:16,840 PRESSURE IN ANTICIPATING AND 4842 03:06:16,840 --> 03:06:18,000 UNDERSTANDING THEIR NEEDS AND 4843 03:06:18,000 --> 03:06:19,560 ADDRESSING THEM PROACTIVELY WITH 4844 03:06:19,560 --> 03:06:22,040 CLEAR DOCUMENTATION AND GUIDANCE 4845 03:06:22,040 --> 03:06:23,280 WAS CRITICAL KEEPING SITES MOTOR 4846 03:06:23,280 --> 03:06:27,320 THE SERRATMOTIVATED AND FOSTERIG 4847 03:06:27,320 --> 03:06:30,240 COMPLIANCE. 4848 03:06:30,240 --> 03:06:34,720 SO I'LL WRAW I'LL WRAP UP TOUCHN 4849 03:06:34,720 --> 03:06:35,120 OPPORTUNITIES. 4850 03:06:35,120 --> 03:06:36,880 FIRST WE SEE AN OPPORTUNITY TO 4851 03:06:36,880 --> 03:06:38,120 STRENGTHEN TECHNOLOGY PLATFORMS 4852 03:06:38,120 --> 03:06:39,960 AT BOTH THE SPONSOR AND SITES, 4853 03:06:39,960 --> 03:06:41,360 TO FACILITATE REMOTE APPROACHES 4854 03:06:41,360 --> 03:06:42,760 TO CLINICAL TRIAL 4855 03:06:42,760 --> 03:06:45,520 IMPLEMENTATION. 4856 03:06:45,520 --> 03:06:46,720 PUTTING TOOLS IN PLACE AND 4857 03:06:46,720 --> 03:06:47,840 HAVING STAFF TRAINED AND 4858 03:06:47,840 --> 03:06:49,400 PROFICIENT WITH SYSTEMS AND 4859 03:06:49,400 --> 03:06:50,320 PROCESSES FOR REMOTE ACTIVITY 4860 03:06:50,320 --> 03:06:54,560 SUCH AS E-CONSENT, REMOTE 4861 03:06:54,560 --> 03:06:55,440 MONITORING, REMOTE LAB 4862 03:06:55,440 --> 03:06:56,880 COLLECTION WOULD FACILITATE 4863 03:06:56,880 --> 03:06:57,320 FUTURE RESEARCH. 4864 03:06:57,320 --> 03:06:58,960 AND WE TYPICALLY WORK WITH 4865 03:06:58,960 --> 03:07:06,160 ACADEMIC RESEARCH INSTITUTIONS 4866 03:07:06,160 --> 03:07:12,080 TO CONDUCT HIV/AIDS RESEARCH. 4867 03:07:12,080 --> 03:07:15,120 TO HELP REACH POPULATIONS THAT 4868 03:07:15,120 --> 03:07:16,960 SOME OF OUR EXISTING SITES DO 4869 03:07:16,960 --> 03:07:18,920 NOT EASILY ACCESS. 4870 03:07:18,920 --> 03:07:22,400 AND OUR RESEARCH IS GLOBAL. 4871 03:07:22,400 --> 03:07:23,240 EX--U.S. REGULATORY APPROVALS 4872 03:07:23,240 --> 03:07:26,560 CAN BE QUITE LENGTHY, IN MANY 4873 03:07:26,560 --> 03:07:27,440 COUNTRIES EXCEEDING SIX MONTHS. 4874 03:07:27,440 --> 03:07:29,600 SO PARTNERING WITH EX--U.S. 4875 03:07:29,600 --> 03:07:31,000 REGULATORS TO BUILD 4876 03:07:31,000 --> 03:07:34,600 RELATIONSHIPS AND IDENTIFY 4877 03:07:34,600 --> 03:07:35,640 OPPORTUNITIES TO EXPEDITE 4878 03:07:35,640 --> 03:07:37,040 APPROVALS WOULD ALLOW THE SITES 4879 03:07:37,040 --> 03:07:37,960 TO GET STARTED MUCH QUICKER IN 4880 03:07:37,960 --> 03:07:41,520 THESE SETTINGS. 4881 03:07:41,520 --> 03:07:42,920 LASTLY, HAVING CONTINGENCY PLANS 4882 03:07:42,920 --> 03:07:44,360 IN PLACE WITH MECHANISMS THAT WE 4883 03:07:44,360 --> 03:07:47,400 CAN QUICKLY ACTIVATE TO MOBILIZE 4884 03:07:47,400 --> 03:07:50,360 TRAINED STAFF WITH EXPERIENCED 4885 03:07:50,360 --> 03:07:51,480 LEADERSHIP AND CLEAR PROJECT 4886 03:07:51,480 --> 03:07:52,560 PLANNING WOULD ALLOW US TO 4887 03:07:52,560 --> 03:07:54,400 IMPLEMENT ROBUST PROJECT PLANS 4888 03:07:54,400 --> 03:07:55,200 RAPIDLY. 4889 03:07:55,200 --> 03:08:01,160 WITH A HIGH LEVEL OF QUALITY. 4890 03:08:01,160 --> 03:08:01,840 SO I'LL STOP THERE. 4891 03:08:01,840 --> 03:08:02,880 THAT'S THE END OF MY 4892 03:08:02,880 --> 03:08:03,200 PRESENTATION. 4893 03:08:03,200 --> 03:08:04,480 I DON'T KNOW IF WE'RE HOLDING 4894 03:08:04,480 --> 03:08:06,000 QUESTIONS FOR AFTER 4895 03:08:06,000 --> 03:08:07,200 DR. WORRELL'S PRESENTATION, BUT 4896 03:08:07,200 --> 03:08:08,600 I'M HAPPY TO ANSWER ANY 4897 03:08:08,600 --> 03:08:09,240 QUESTIONS ABOUT THE INFORMATION 4898 03:08:09,240 --> 03:08:10,480 I SHARED. 4899 03:08:10,480 --> 03:08:10,920 >>GREAT. 4900 03:08:10,920 --> 03:08:13,440 THANK YOU. 4901 03:08:13,440 --> 03:08:14,720 THANK YOU, REALLY HIGHLIGHTING 4902 03:08:14,720 --> 03:08:15,720 SOME OF THE CHALLENGES AND 4903 03:08:15,720 --> 03:08:17,120 SUCCESSES. 4904 03:08:17,120 --> 03:08:20,760 ARE WHY DON'WHY DON'T WE TAKE ON 4905 03:08:20,760 --> 03:08:28,400 FROM DR. WALLACE. 4906 03:08:28,400 --> 03:08:33,800 IS IT FAWN, DSTEPHAUN, DO YOU HN 4907 03:08:33,800 --> 03:08:35,280 >>CAN YOU HEAR ME NOW? 4908 03:08:35,280 --> 03:08:35,920 >>YEAH. 4909 03:08:35,920 --> 03:08:36,160 >>OKAY. 4910 03:08:36,160 --> 03:08:36,720 THANK YOU FOR THAT. 4911 03:08:36,720 --> 03:08:38,880 THANK YOU FOR THE PRESENTATION, 4912 03:08:38,880 --> 03:08:39,520 MANIZHE. 4913 03:08:39,520 --> 03:08:42,880 AMAZINAMAZING WORK IS BEING DONE 4914 03:08:42,880 --> 03:08:44,640 ACROSS THE BOARD, AND I WANT TO 4915 03:08:44,640 --> 03:08:45,520 ACKNOWLEDGE IN PARTICULAR THE 4916 03:08:45,520 --> 03:08:49,040 WORK THAT WAS DONE TO -- WHICH 4917 03:08:49,040 --> 03:08:50,880 IS OFTEN NOT HIGHLIGHTED, THE 4918 03:08:50,880 --> 03:08:54,600 WORK THAT WAS DONE TO BRING ON 4919 03:08:54,600 --> 03:08:55,920 THE HISTORICALLY BLACK MEDICAL 4920 03:08:55,920 --> 03:08:57,800 COLLEGES DURING THE COVID WORK, 4921 03:08:57,800 --> 03:09:01,280 AND HOW BRINGING ON THOSE 4922 03:09:01,280 --> 03:09:02,560 INSTITUTIONS AS 4923 03:09:02,560 --> 03:09:04,320 PROTOCOL-SPECIFIC SITES REALLY 4924 03:09:04,320 --> 03:09:05,760 SUPPORTED THE COVID-19 RESEARCH 4925 03:09:05,760 --> 03:09:09,800 RESPONSE, INCLUDING ACTIVELY 4926 03:09:09,800 --> 03:09:11,360 ENGAGING WITH THE COVID-19 4927 03:09:11,360 --> 03:09:12,360 PROVISION THAT WERE TRIALS. 4928 03:09:12,360 --> 03:09:13,400 THE IMPACT OF BRINGING THESE 4929 03:09:13,400 --> 03:09:16,160 SITES ON, I THINK REALLY HELPED 4930 03:09:16,160 --> 03:09:19,080 TO ENGENDER TRUST IN KEY 4931 03:09:19,080 --> 03:09:20,040 COMMUNITIES, ASSIST IT WITH 4932 03:09:20,040 --> 03:09:22,240 BUILDING AND EXPANDING TRUSTED 4933 03:09:22,240 --> 03:09:25,200 VOICES IN COVID-19 SCIENCE, AND 4934 03:09:25,200 --> 03:09:28,800 OF COURSE SUPPORTED US SEEING 4935 03:09:28,800 --> 03:09:30,000 THE DIVERSITY IN THE COVID-19 4936 03:09:30,000 --> 03:09:33,520 VACCINE TRIALS THAT WE SAW. 4937 03:09:33,520 --> 03:09:34,680 SOME OF THE FEEDBACK THAT I 4938 03:09:34,680 --> 03:09:36,320 CONTINUE TO HEAR FROM COLLEAGUES 4939 03:09:36,320 --> 03:09:39,400 AND COMMUNITIES IS REGARDING 4940 03:09:39,400 --> 03:09:40,840 WHAT IS HAPPENING TO LEVERAGE 4941 03:09:40,840 --> 03:09:46,280 THESE SAME INSTITUTIONS, AND NOW 4942 03:09:46,280 --> 03:09:49,600 THERE ARE SIX WITH THE INCLUSION 4943 03:09:49,600 --> 03:09:52,120 OF MORGAN STATE AND BALTIMORE 4944 03:09:52,120 --> 03:09:53,440 AND XAVIER UNIVERSITY IN NEW 4945 03:09:53,440 --> 03:09:54,480 ORLEANS, SO NOW THERE ARE A 4946 03:09:54,480 --> 03:09:56,400 TOTAL OF SIX, IN HIV RESEARCH 4947 03:09:56,400 --> 03:09:57,840 AND TO ENSURE MORE IS BEING DONE 4948 03:09:57,840 --> 03:10:00,800 TO DEVELOP KEY PARTNERSHIPS WITH 4949 03:10:00,800 --> 03:10:02,200 THESE INSTITUTIONS AND OTHER 4950 03:10:02,200 --> 03:10:05,960 MINORITY SERVING INSTITUTIONS. 4951 03:10:05,960 --> 03:10:09,120 >>THANK YOU, STEPHAUN, FOR 4952 03:10:09,120 --> 03:10:09,320 THAT. 4953 03:10:09,320 --> 03:10:11,360 I THINK YOU POINT OUT A REALLY 4954 03:10:11,360 --> 03:10:13,160 IMPORTANT ASPECT OF OUR ABILITY 4955 03:10:13,160 --> 03:10:15,360 TO ADVANCE THE PANDEMIC RESEARCH 4956 03:10:15,360 --> 03:10:16,880 BUT ALSO LINKING IT BACK TO THE 4957 03:10:16,880 --> 03:10:18,080 HIV/AIDS RESEARCH. 4958 03:10:18,080 --> 03:10:19,920 THE NIAID SORT OF HAD AN 4959 03:10:19,920 --> 03:10:22,560 INTEGRATED APPROACH TO BRINGING 4960 03:10:22,560 --> 03:10:25,040 ON HBCUs TO SUPPORT NIAID 4961 03:10:25,040 --> 03:10:26,680 RESEARCH PRIORITIES. 4962 03:10:26,680 --> 03:10:28,480 OUR DMID, OUR SISTER DIVISION, 4963 03:10:28,480 --> 03:10:30,840 HAS WORKED CLOSELY, BRINGING ON 4964 03:10:30,840 --> 03:10:33,480 SOME HBCUs TO SUPPORT SOME OF 4965 03:10:33,480 --> 03:10:34,880 THE PRIORITIES THEY'RE WORKING 4966 03:10:34,880 --> 03:10:38,480 IN AROUND COVID -- THE COVID 4967 03:10:38,480 --> 03:10:38,720 RESPONSE. 4968 03:10:38,720 --> 03:10:41,120 WE HAVE WORKED WITH SOME OF THE 4969 03:10:41,120 --> 03:10:45,600 HBCUs WITHIN THE COVPN AND 4970 03:10:45,600 --> 03:10:46,960 IT'S A SORT OF INTEGRATED 4971 03:10:46,960 --> 03:10:48,760 APPROACH THAT WE'RE PURSUING TO 4972 03:10:48,760 --> 03:10:49,520 BE ABLE TO GET MORE EXPERIENCE 4973 03:10:49,520 --> 03:10:50,760 WITH THE HBCUs. 4974 03:10:50,760 --> 03:10:52,400 WITHIN THE DIVISION OF AIDS, WE 4975 03:10:52,400 --> 03:10:55,120 DO HAVE A MODEL THAT RELIES ON 4976 03:10:55,120 --> 03:10:57,320 SORT OF A SOLICITATION AND A 4977 03:10:57,320 --> 03:11:00,480 GRANT-BASED APPROACH TO 4978 03:11:00,480 --> 03:11:01,400 SUPPORTING SITES, AND WE WOULD 4979 03:11:01,400 --> 03:11:03,440 WELCOME THEM TO COMPETE IN THE 4980 03:11:03,440 --> 03:11:04,240 UPCOMING SOLICITATION THAT'S 4981 03:11:04,240 --> 03:11:07,160 GOING TO BE COMING UP. 4982 03:11:07,160 --> 03:11:08,280 BUT THERE IS MORE OF AN 4983 03:11:08,280 --> 03:11:09,680 INTEGRATED APPROACH ACROSS THE 4984 03:11:09,680 --> 03:11:11,880 INSTITUTE INVOLVING THE HBCUs 4985 03:11:11,880 --> 03:11:14,320 IN THE RESEARCH PRIORITIES. 4986 03:11:14,320 --> 03:11:15,560 >>GREAT. 4987 03:11:15,560 --> 03:11:16,760 THANK YOU, MANIZHE. 4988 03:11:16,760 --> 03:11:20,160 WE'RE GOING TO MOVE TO OUR LAST 4989 03:11:20,160 --> 03:11:20,720 PRESENTATION. 4990 03:11:20,720 --> 03:11:22,760 THE OFFICE FOR POLICY AND 4991 03:11:22,760 --> 03:11:24,200 CLINICAL RESEARCH OPERATIONS, 4992 03:11:24,200 --> 03:11:25,080 DR. CAROL WORRELL, AND THEN 4993 03:11:25,080 --> 03:11:26,480 WE'LL HAVE SOME TIME FOR -- A 4994 03:11:26,480 --> 03:11:27,280 FEW MINUTES FOR DISCUSSION AT 4995 03:11:27,280 --> 03:11:28,800 THE END. 4996 03:11:28,800 --> 03:11:31,000 >>THANK YOU, KEN, AND THANK YOU 4997 03:11:31,000 --> 03:11:33,680 FOR THE OPPORTUNITY TO PRESENT. 4998 03:11:33,680 --> 03:11:34,440 OKAY. 4999 03:11:34,440 --> 03:11:37,840 SO I'M GOING TO PRESENT LESSONS 5000 03:11:37,840 --> 03:11:39,680 LEARNED FROM THE PANDEMIC, FROM 5001 03:11:39,680 --> 03:11:43,520 A CLINICAL TRIAL OPERATIONS 5002 03:11:43,520 --> 03:11:47,320 PERSPECTIVE. 5003 03:11:47,320 --> 03:11:48,680 I WANTED TO MAKE SURE I 5004 03:11:48,680 --> 03:11:50,160 ACKNOWLEDGE MY TEAM, SO I PUT 5005 03:11:50,160 --> 03:11:56,120 THIS SLIDE FIRST. 5006 03:11:56,120 --> 03:11:58,280 THIS GROUP HAS RESPONDED 5007 03:11:58,280 --> 03:11:59,840 TREMENDOUSLY THROUGHOUT THE 5008 03:11:59,840 --> 03:12:01,800 PANDEMIC, AND I WANTED TO ALSO 5009 03:12:01,800 --> 03:12:03,520 ACKNOWLEDGE SOME OF OUR FORMER 5010 03:12:03,520 --> 03:12:06,240 STAFF MEMBERS WHO ALSO MADE 5011 03:12:06,240 --> 03:12:07,640 REALLY SIGNIFICANT CONTRIBUTIONS 5012 03:12:07,640 --> 03:12:14,920 BEFORE THEY LEFT. 5013 03:12:14,920 --> 03:12:16,120 SO WHAT WORKED? 5014 03:12:16,120 --> 03:12:19,640 THE SCIENCE WAS READY. 5015 03:12:19,640 --> 03:12:20,840 THE ALL OF GOVERNMENT APPROACH 5016 03:12:20,840 --> 03:12:22,560 WHICH BROUGHT RESOURCES NEEDED 5017 03:12:22,560 --> 03:12:23,680 TO MEET THE CHALLENGE, AND I 5018 03:12:23,680 --> 03:12:25,200 WON'T GO INTO THAT IN DEPTH 5019 03:12:25,200 --> 03:12:27,480 BECAUSE I BELIEVE MARY ALREADY 5020 03:12:27,480 --> 03:12:27,640 DID. 5021 03:12:27,640 --> 03:12:29,280 AND THIS INCLUDES THE ALL OF 5022 03:12:29,280 --> 03:12:31,240 NIAID RESPONSE, WHERE NIAID 5023 03:12:31,240 --> 03:12:35,320 LEVERAGED ALL OF ITS NETWORKS. 5024 03:12:35,320 --> 03:12:36,400 ALL OF THE NETWORK 5025 03:12:36,400 --> 03:12:39,680 INFRASTRUCTURE. 5026 03:12:39,680 --> 03:12:41,240 THE SUCCESS OF A FULL TIME 5027 03:12:41,240 --> 03:12:42,640 REMOTE WORKING ENVIRONMENT WAS A 5028 03:12:42,640 --> 03:12:43,760 LITTLE BIT UNEXPECTED AND 5029 03:12:43,760 --> 03:12:47,440 SOMEWHAT OF A SURPRISE, BUT IT 5030 03:12:47,440 --> 03:12:48,520 WORKED EXTREMELY WELL. 5031 03:12:48,520 --> 03:12:49,720 THE USE OF REMOTE TECHNOLOGY 5032 03:12:49,720 --> 03:12:51,600 SUCH AS E CONSENT AND REMOTE 5033 03:12:51,600 --> 03:12:53,000 MONITORING, ALTHOUGH THEY WERE 5034 03:12:53,000 --> 03:12:57,520 LIMITED, WAS EXTREMELY HELPFUL. 5035 03:12:57,520 --> 03:12:59,360 WE ACTUALLY WERE LUCKY IN 5036 03:12:59,360 --> 03:13:00,640 RECEIVING ADVICE AND WORKING 5037 03:13:00,640 --> 03:13:02,800 WITH FORMER INDUSTRY EXECUTIVES 5038 03:13:02,800 --> 03:13:04,280 WITH DECADES OF EXPERIENCE 5039 03:13:04,280 --> 03:13:05,560 REGARDING SOME OF OUR 5040 03:13:05,560 --> 03:13:09,400 OPERATIONAL CHALLENGES. 5041 03:13:09,400 --> 03:13:12,320 AND THE ABILITY AND WILLINGNESS 5042 03:13:12,320 --> 03:13:13,960 OF DAIDS STAFF TO ABSORB AND ACT 5043 03:13:13,960 --> 03:13:15,360 ON THE STEEP AND RAPID LEARNING 5044 03:13:15,360 --> 03:13:17,560 CURVE WITH RESPECT TO 5045 03:13:17,560 --> 03:13:19,520 OPERATIONAL MODELS WAS REALLY 5046 03:13:19,520 --> 03:13:20,480 IMPRESSIVE. 5047 03:13:20,480 --> 03:13:22,280 SO I WANT TO DRAW YOUR ATTENTION 5048 03:13:22,280 --> 03:13:25,240 TO THESE LAST THREE BULLETS, 5049 03:13:25,240 --> 03:13:26,920 WHICH SHOW THE PROGRESSION -- 5050 03:13:26,920 --> 03:13:29,080 SHOW HOW WE PROGRESSED 5051 03:13:29,080 --> 03:13:31,360 OPERATIONALLY, SO STARTING WITH 5052 03:13:31,360 --> 03:13:32,880 ACTIV 2, WE STARTED WITH A FULL 5053 03:13:32,880 --> 03:13:35,760 SERVICE CLINICAL RESEARCH 5054 03:13:35,760 --> 03:13:38,040 ORGANIZATION MODEL, MEANING WE 5055 03:13:38,040 --> 03:13:40,640 CONTRACTED OUT ALL OF OUR 5056 03:13:40,640 --> 03:13:43,400 OPERATIONS TO A SINGLE CRO. 5057 03:13:43,400 --> 03:13:47,640 FOR ACTIV 2B AND 2C, WE WERE NOT 5058 03:13:47,640 --> 03:13:50,720 HAPPY WITH THAT. 5059 03:13:50,720 --> 03:13:52,440 ACTIV 2B AND 2C WHICH ACTUALLY 5060 03:13:52,440 --> 03:13:53,680 NEVER GOT OFF THE GROUND, WE 5061 03:13:53,680 --> 03:13:54,680 WERE GOING TO FOLLOW A 5062 03:13:54,680 --> 03:13:56,720 FUNCTIONAL AREA MODEL WHERE WE 5063 03:13:56,720 --> 03:14:00,320 CONTRACTED OUT PARTS OF OUR 5064 03:14:00,320 --> 03:14:02,440 OPERATIONS, AND FOR A5418, WHICH 5065 03:14:02,440 --> 03:14:04,360 IS THE MPOX TRIAL, WE ENDED BACK 5066 03:14:04,360 --> 03:14:07,240 WHERE WE STARTED WITH A NORMAL 5067 03:14:07,240 --> 03:14:09,200 NETWORK TRIAL THAT WAS MADE 5068 03:14:09,200 --> 03:14:10,320 POSSIBLE DUE TO SOME 5069 03:14:10,320 --> 03:14:10,960 IMPROVEMENTS IN OUR 5070 03:14:10,960 --> 03:14:16,200 INFRASTRUCTURE. 5071 03:14:16,200 --> 03:14:18,040 SO IN TERMS OF WHAT DIDN'T WORK, 5072 03:14:18,040 --> 03:14:19,840 WE RUSHED. 5073 03:14:19,840 --> 03:14:25,880 AS YOU RECALL, WE STARTED IN 5074 03:14:25,880 --> 03:14:29,480 MARCH OF 2020, AND EVERYONE IN 5075 03:14:29,480 --> 03:14:30,680 THE SCIENTIFIC COMMUNITY FELT WE 5076 03:14:30,680 --> 03:14:33,520 WERE ALREADY WAY BEHIND. 5077 03:14:33,520 --> 03:14:39,200 SO ACTIVE 2 WAS DAIDS AND THE 5078 03:14:39,200 --> 03:14:41,760 ACTG'S FIRST ATTEMPT TO 5079 03:14:41,760 --> 03:14:43,320 IMPLEMENT AN ADAPTIVE PLATFORM 5080 03:14:43,320 --> 03:14:44,480 TRIAL. 5081 03:14:44,480 --> 03:14:46,760 IT TH TRIAL WAS LARGE, HAD AN 5082 03:14:46,760 --> 03:14:48,080 ELEGANT DESIGN, VERY M A BISHES 5083 03:14:48,080 --> 03:14:49,880 GOALS AND OUR EXISTING TRIAL 5084 03:14:49,880 --> 03:14:50,800 INFRASTRUCTURE COULD NOT SUPPORT 5085 03:14:50,800 --> 03:14:55,760 IT. 5086 03:14:55,760 --> 03:14:58,160 IN THE PROCESS OF AUGMENTING OUR 5087 03:14:58,160 --> 03:14:59,400 EXISTING CAPABILITIES WOULD HAVE 5088 03:14:59,400 --> 03:15:00,680 DELAYED THE TRIAL OPENING BY 5089 03:15:00,680 --> 03:15:02,960 SEVERAL WEEKS IF NOT MONTHS, AND 5090 03:15:02,960 --> 03:15:05,760 BY CAPABILITIES IN 5091 03:15:05,760 --> 03:15:07,000 INFRASTRUCTURE, I MEAN BOTH 5092 03:15:07,000 --> 03:15:11,040 WITHIN DAIDS AND OUR NETWORKS. 5093 03:15:11,040 --> 03:15:14,160 SO IN TERMS OF THE COMPLEXITY OF 5094 03:15:14,160 --> 03:15:15,680 THE TRIAL DESIGN AND THE MOVE 5095 03:15:15,680 --> 03:15:19,920 AWAY FROM OUR EXISTING 5096 03:15:19,920 --> 03:15:21,000 INFRASTRUCTURE PROVED TO BE A 5097 03:15:21,000 --> 03:15:21,360 MISTAKE. 5098 03:15:21,360 --> 03:15:23,320 I WAS PART OF MAKING THAT 5099 03:15:23,320 --> 03:15:27,240 DECISION WITH MANY UNINTENDED 5100 03:15:27,240 --> 03:15:27,680 CONSEQUENCES. 5101 03:15:27,680 --> 03:15:28,560 BUT AS IS TRUE IN THE 5102 03:15:28,560 --> 03:15:32,080 GOVERNMENT, IT TOOK A VILLAGE TO 5103 03:15:32,080 --> 03:15:33,280 MAKE THAT JUDGMENT AND THERE WAS 5104 03:15:33,280 --> 03:15:34,600 QUITE A BIT THAT WE COULDN'T 5105 03:15:34,600 --> 03:15:38,000 REALLY FORESEE. 5106 03:15:38,000 --> 03:15:40,520 SO I WOULD JUST SAY BUILDING NEW 5107 03:15:40,520 --> 03:15:41,520 TRIAL INFRASTRUCTURE AND NEW 5108 03:15:41,520 --> 03:15:43,560 TRIAL DESIGNS IN THIS CONTEXT, 5109 03:15:43,560 --> 03:15:49,760 YOU SHOULD JUST NOT DO THAT. 5110 03:15:49,760 --> 03:15:50,840 DAIDS ALSO SOMETHING THAT REALLY 5111 03:15:50,840 --> 03:15:54,000 GOT IN OUR WAY WAS OUR ACCESS TO 5112 03:15:54,000 --> 03:15:56,600 FEDERAL CONTRACT MECHANISMS, SO 5113 03:15:56,600 --> 03:15:57,800 WHEN WE HAD TO USE -- THERE WAS 5114 03:15:57,800 --> 03:15:59,040 ONLY ONE VEHICLE WE COULD USE, 5115 03:15:59,040 --> 03:16:02,840 IT WAS NOT DESIGNED TO 5116 03:16:02,840 --> 03:16:04,920 ACCOMMODATE CLINICAL TRIALS. 5117 03:16:04,920 --> 03:16:07,040 AND IT FORCED THE USE OF A 5118 03:16:07,040 --> 03:16:08,000 SINGLE CRO. 5119 03:16:08,000 --> 03:16:10,960 WE DIDN'T HAVE ANY COMPETITION 5120 03:16:10,960 --> 03:16:11,880 THERE. 5121 03:16:11,880 --> 03:16:14,880 SO THE COMPLEXITY OF THE TRIAL 5122 03:16:14,880 --> 03:16:16,400 DESIGN AS I'VE SAID SEVERAL 5123 03:16:16,400 --> 03:16:18,560 TIMES IN THIS SLIDE INTRODUCED 5124 03:16:18,560 --> 03:16:21,880 EXCEPTIONAL AMOUNTS OF OPERATION 5125 03:16:21,880 --> 03:16:22,200 COMPLEXITY. 5126 03:16:22,200 --> 03:16:23,600 THE STAFF HAD TO CREATE NEW 5127 03:16:23,600 --> 03:16:25,480 PROCESSES FOR DAIDS OVERSIGHT, 5128 03:16:25,480 --> 03:16:29,200 WHICH WAS AN ENORMOUS AND 5129 03:16:29,200 --> 03:16:30,000 TIME-CONSUMING JOB. 5130 03:16:30,000 --> 03:16:31,200 AND ALSO AS A RESULT OF SOME OF 5131 03:16:31,200 --> 03:16:33,840 THOSE CHANGES, WE HAD TO DEAL 5132 03:16:33,840 --> 03:16:37,120 WITH RECONFIGURING OUR CLINICAL 5133 03:16:37,120 --> 03:16:42,840 RESEARCH MANAGEMENT SYSTEM, 5134 03:16:42,840 --> 03:16:44,440 CRMS, WHICH INVOLVED UNRAVELING 5135 03:16:44,440 --> 03:16:46,600 HOW THE PROCESSES MOVE THROUGH 5136 03:16:46,600 --> 03:16:49,480 THE SYSTEM AND WERE 5137 03:16:49,480 --> 03:16:50,880 INTERCONNECTED, AND THAT WAS 5138 03:16:50,880 --> 03:16:54,720 EXTREMELY LABOR-INTENSIVE AND 5139 03:16:54,720 --> 03:16:57,480 TIME-CONSUMING, AND LED BY OUR 5140 03:16:57,480 --> 03:16:58,760 PROTOCOL REGISTRATION STAFF AND 5141 03:16:58,760 --> 03:17:01,360 THE MAIN EFFORT WAS LED BY 5142 03:17:01,360 --> 03:17:02,280 MANIZHE. 5143 03:17:02,280 --> 03:17:05,000 AS THE PANDEMIC WORE ON, STAFF 5144 03:17:05,000 --> 03:17:06,520 ATTRITION INCREASED, PARTLY DUE 5145 03:17:06,520 --> 03:17:09,200 TO COMPETITION FROM INDUSTRY AND 5146 03:17:09,200 --> 03:17:10,720 RETIREMENTS, BUT ALSO FOR 5147 03:17:10,720 --> 03:17:15,000 VARIOUS REASONS INCLUDING JUST 5148 03:17:15,000 --> 03:17:15,760 INABILITY TO CONTINUE TO 5149 03:17:15,760 --> 03:17:22,000 TOLERATE THE WORK. 5150 03:17:22,000 --> 03:17:23,000 SO WHAT ARE OUR OPPORTUNITIES 5151 03:17:23,000 --> 03:17:25,920 AND PATHWAYS FORWARD? 5152 03:17:25,920 --> 03:17:27,600 OBVIOUSLY WHEN WE DO THIS AGAIN, 5153 03:17:27,600 --> 03:17:29,680 WE'LL KEEP THINGS SIMPLE, BUT I 5154 03:17:29,680 --> 03:17:33,720 WOULD SAY SIMPLE IN THIS CONTEXT 5155 03:17:33,720 --> 03:17:40,200 IS ALREADY RIDICULOUSLY 5156 03:17:40,200 --> 03:17:40,640 COMPLICATED. 5157 03:17:40,640 --> 03:17:42,120 STICK TO WHAT WE KNOW, 5158 03:17:42,120 --> 03:17:46,760 ESPECIALLY WHEN WE'RE HURRIED. 5159 03:17:46,760 --> 03:17:48,280 DAIDS AND ITS NETWORK 5160 03:17:48,280 --> 03:17:48,960 COLLABORATORS WILL CONTINUE 5161 03:17:48,960 --> 03:17:52,520 THEIR EFFORTS TO IMPROVE OUR 5162 03:17:52,520 --> 03:17:53,200 EXISTING INFRASTRUCTURE IN THE 5163 03:17:53,200 --> 03:17:56,600 CONTEXT OF PLANNING FOR SUCCESS 5164 03:17:56,600 --> 03:17:58,760 AND ENDING THE HIV PANDEMIC, 5165 03:17:58,760 --> 03:18:00,200 WHICH WILL HOPEFULLY LEAVE US 5166 03:18:00,200 --> 03:18:03,600 BETTER PREPARED FOR A FUTURE 5167 03:18:03,600 --> 03:18:05,160 PANDEMIC, WHICH I THINK WE ALL 5168 03:18:05,160 --> 03:18:09,200 AGREE IS LIKELY. 5169 03:18:09,200 --> 03:18:10,080 AND JUST TO REFER BACK TO THE 5170 03:18:10,080 --> 03:18:11,400 LAST SLIDE, IT WAS IMPROVEMENTS 5171 03:18:11,400 --> 03:18:12,440 IN INFRASTRUCTURE THAT ALLOWED 5172 03:18:12,440 --> 03:18:16,640 US TO RETURN BACK TO OUR REGULAR 5173 03:18:16,640 --> 03:18:17,400 NETWORK STRUCTURE. 5174 03:18:17,400 --> 03:18:18,680 AND EVEN IN TRIAL DESIGN, I 5175 03:18:18,680 --> 03:18:22,080 WOULD SAY IT WAS AN IMPROVEMENT 5176 03:18:22,080 --> 03:18:24,400 FOR MPOX THAT PREGNANT WOMEN AND 5177 03:18:24,400 --> 03:18:25,280 CHILDREN COULD BE INCLUDED. 5178 03:18:25,280 --> 03:18:27,240 BUT I'M A PEDIATRICIAN, SO WHAT 5179 03:18:27,240 --> 03:18:28,240 CAN YOU SAY? 5180 03:18:28,240 --> 03:18:31,120 WE ALREADY HAVE EVIDENCE OF 5181 03:18:31,120 --> 03:18:32,880 HOW -- AS I SAID, OF HOW THESE 5182 03:18:32,880 --> 03:18:36,920 IMPROVEMENTS CAN HELP, AND A5418 5183 03:18:36,920 --> 03:18:38,120 OPENED IN SEVEN WEEKS, WHICH WAS 5184 03:18:38,120 --> 03:18:41,400 A RECORD. 5185 03:18:41,400 --> 03:18:43,720 DAIDS HAS INITIATED -- MOVING 5186 03:18:43,720 --> 03:18:44,920 FORWARD, DAIDS HAS INITIATED A 5187 03:18:44,920 --> 03:18:47,400 WORKING GROUP AS WE DO TO 5188 03:18:47,400 --> 03:18:49,920 IDENTIFY AND ADDRESS GAPS IN ITS 5189 03:18:49,920 --> 03:18:51,560 PROCESSES, INCLUDING THE USE OF 5190 03:18:51,560 --> 03:18:54,680 REMOTE TECHNOLOGY FOR CLINICAL 5191 03:18:54,680 --> 03:18:57,600 TRIAL PARTICIPATION AND 5192 03:18:57,600 --> 03:18:57,920 OPERATIONS. 5193 03:18:57,920 --> 03:18:59,600 WE'LL CONTINUE TO DEVELOP AND 5194 03:18:59,600 --> 03:19:02,960 REFINE OUR PROCESSES. 5195 03:19:02,960 --> 03:19:04,920 AND ON A MORE INTERESTING NOTE, 5196 03:19:04,920 --> 03:19:08,440 WE STARTED WORK WITH ELECTRONIC 5197 03:19:08,440 --> 03:19:11,120 SYSTEMS CONSULTANTS TO ATTEMPT 5198 03:19:11,120 --> 03:19:12,640 TO REDUCE THE COMPLEXITY OF THE 5199 03:19:12,640 --> 03:19:17,200 LARGE NUMBER OF SYSTEMS REQUIRED 5200 03:19:17,200 --> 03:19:18,840 TO CARRY OUT EACH CLINICAL 5201 03:19:18,840 --> 03:19:21,040 TRIAL, WHICH IS USUALLY MORE 5202 03:19:21,040 --> 03:19:24,360 THAN 20 DIFFERENT SYSTEMS FOR 5203 03:19:24,360 --> 03:19:26,320 TRIAL, BOTH WITHIN DAIDS AT OUR 5204 03:19:26,320 --> 03:19:28,200 VENDORS -- AT OUR -- SORRY -- 5205 03:19:28,200 --> 03:19:29,640 GRANTEES AND AT SITES. 5206 03:19:29,640 --> 03:19:32,320 AND TO REDUCE THE BURDEN ON 5207 03:19:32,320 --> 03:19:33,920 USERS. 5208 03:19:33,920 --> 03:19:37,160 AND OBVIOUSLY GOING BACK TO THE 5209 03:19:37,160 --> 03:19:40,240 PAPANDEMIC, WE OBVIOUSLY NEED 5210 03:19:40,240 --> 03:19:41,160 SCIENCE THAT IS MATURE ENOUGH TO 5211 03:19:41,160 --> 03:19:42,560 MOVE FORWARD TO CLINICAL TRIALS, 5212 03:19:42,560 --> 03:19:45,960 WHICH IS AS MUCH OF A STATEMENT 5213 03:19:45,960 --> 03:19:49,040 AS I AM ALLOWED TO MAKE AS AN 5214 03:19:49,040 --> 03:19:49,880 EMPLOYEE OF THE EXECUTIVE 5215 03:19:49,880 --> 03:19:53,600 BRANCH. 5216 03:19:53,600 --> 03:19:54,480 SO THAT IS THAT. 5217 03:19:54,480 --> 03:19:55,400 I'M DONE. 5218 03:19:55,400 --> 03:19:57,800 AND I WILL BE HAPPY TO ANSWER 5219 03:19:57,800 --> 03:20:00,560 ANY QUESTIONS ABOUT SOME OF THE 5220 03:20:00,560 --> 03:20:01,760 CHALLENGES WE'VE FACED. 5221 03:20:01,760 --> 03:20:03,080 >>THANK YOU, DR. WORRELL. 5222 03:20:03,080 --> 03:20:04,080 I HAVE ALWAYS THOUGHT THAT I'VE 5223 03:20:04,080 --> 03:20:07,760 LEARNED MORE FROM MY OWN 5224 03:20:07,760 --> 03:20:09,520 FAILURES THAN SUCCESSES AND I 5225 03:20:09,520 --> 03:20:11,720 THINK YOUR CANDOR AND ABILITY TO 5226 03:20:11,720 --> 03:20:14,680 DESCRIBE SOME OF THE CHALLENGES 5227 03:20:14,680 --> 03:20:17,320 IS BOTH REFRESHING AND HELPFUL 5228 03:20:17,320 --> 03:20:18,640 TO ALL OF US. 5229 03:20:18,640 --> 03:20:21,160 SO WE HAVE ABOUT -- LET'S SEE IF 5230 03:20:21,160 --> 03:20:25,640 WE HAVE A QUESTION FOR 5231 03:20:25,640 --> 03:20:26,680 DR. WORRELL, AND THEN WE HAVE 5232 03:20:26,680 --> 03:20:28,280 FIVE MINUTES FOR BROADER 5233 03:20:28,280 --> 03:20:29,040 DISCUSSION. 5234 03:20:29,040 --> 03:20:39,440 SO ANYTHING SPECIFIC? 5235 03:20:41,520 --> 03:20:43,120 WHY DON'T WE OPEN IT UP BROADLY 5236 03:20:43,120 --> 03:20:45,000 AND LET ME REMIND FOLKS THAT THE 5237 03:20:45,000 --> 03:20:45,880 ECB HAS ALL OF THE SLIDES FROM 5238 03:20:45,880 --> 03:20:47,320 ALL OF THE PRESENTATIONS, 5239 03:20:47,320 --> 03:20:49,520 TREMENDOUS AMOUNT OF REALLY 5240 03:20:49,520 --> 03:20:52,160 EXCITING DATA, SO PEOPLE CAN 5241 03:20:52,160 --> 03:20:53,360 LOOK AT THOSE GOING FORWARD AS 5242 03:20:53,360 --> 03:20:55,880 WELL. 5243 03:20:55,880 --> 03:20:56,160 DR. GUPTA. 5244 03:20:56,160 --> 03:20:56,640 >>YES, HI. 5245 03:20:56,640 --> 03:20:57,440 THANK YOU. 5246 03:20:57,440 --> 03:21:00,600 IT BEEN AN INCREDIBLE SORT OF 5247 03:21:00,600 --> 03:21:03,000 INFORMATION AND SORT OF 5248 03:21:03,000 --> 03:21:04,960 REFLECTION OF SO MUCH LESSONS 5249 03:21:04,960 --> 03:21:06,280 LEARNED AND JUST SO MUCH 5250 03:21:06,280 --> 03:21:07,800 HAPPENING AT THE LEVEL OF DAIDS. 5251 03:21:07,800 --> 03:21:08,800 IT'S THRILLING. 5252 03:21:08,800 --> 03:21:11,120 IT'S NEVER A DULL MOMENT. 5253 03:21:11,120 --> 03:21:12,960 SO I THINK I BROUGHT THIS UP 5254 03:21:12,960 --> 03:21:15,600 SORT OF EARLIER WHEN WE HAD OUR 5255 03:21:15,600 --> 03:21:16,560 SMALLER GROUP CALL IN 5256 03:21:16,560 --> 03:21:19,000 PREPARATION FOR THIS, BUT I'M 5257 03:21:19,000 --> 03:21:20,200 REALLY SORT OF INTERESTED TO 5258 03:21:20,200 --> 03:21:22,960 KNOW HOW DAIDS IS TAKING ON THE 5259 03:21:22,960 --> 03:21:26,640 SORT OF REVIEW OF WHAT KIND OF 5260 03:21:26,640 --> 03:21:27,560 INVESTMENT WILL HAPPEN WITH 5261 03:21:27,560 --> 03:21:28,640 TECHNOLOGY TO DO RAPID 5262 03:21:28,640 --> 03:21:30,280 DEPLOYMENT OF TRIALS FOR 5263 03:21:30,280 --> 03:21:31,760 PANDEMICS, FOR NEW THERAPEUTICS, 5264 03:21:31,760 --> 03:21:34,600 TO REALLY LEVER UP THE TIMELINES 5265 03:21:34,600 --> 03:21:39,440 AND EFFICIENCIES, IF YOU WILL. 5266 03:21:39,440 --> 03:21:41,280 I MYSELF AM GETTING BOMBARDED BY 5267 03:21:41,280 --> 03:21:42,400 ALL THESE COMPANIES THAT HAVE 5268 03:21:42,400 --> 03:21:44,880 THESE REALLY INCREDIBLE 5269 03:21:44,880 --> 03:21:46,560 PLATFORMS FOR DOING TRIALS 5270 03:21:46,560 --> 03:21:48,000 ACROSS THE GLOBE, AND HAVE ALL 5271 03:21:48,000 --> 03:21:52,360 SORTS OF BELLS AND WHISTLES, AND 5272 03:21:52,360 --> 03:21:53,480 SO I'M JUST INTRIGUED BY ALL 5273 03:21:53,480 --> 03:21:54,360 THAT YOU'VE LEARNED FROM THIS, 5274 03:21:54,360 --> 03:21:55,880 HOW ARE WE GOING TO DO IT BETTER 5275 03:21:55,880 --> 03:21:57,320 WITH AT LEAST THAT IN MIND, 5276 03:21:57,320 --> 03:21:59,840 SINCE THAT WAS ONE OF THE POINTS 5277 03:21:59,840 --> 03:22:02,120 YOU, CARL RAISED AND A FEW 5278 03:22:02,120 --> 03:22:04,000 OTHERS HAVE BROUGHT UP. 5279 03:22:04,000 --> 03:22:06,640 >>SO I CAN START WITH IT. 5280 03:22:06,640 --> 03:22:09,040 SO WITH THE BRINGING ON BOARD 5281 03:22:09,040 --> 03:22:12,680 THE CONSULTANT, WHAT WE'RE 5282 03:22:12,680 --> 03:22:13,760 TRYING TO DO IS ADDRESS, YOU 5283 03:22:13,760 --> 03:22:15,440 KNOW, ADDRESS OUR ELECTRONIC 5284 03:22:15,440 --> 03:22:16,880 SYSTEMS AND OUR COMPUTER WORK, 5285 03:22:16,880 --> 03:22:18,480 OUR SOFTWARE, ET CETERA, IN A 5286 03:22:18,480 --> 03:22:19,920 MORE HOLISTIC AND COMPREHENSIVE 5287 03:22:19,920 --> 03:22:20,360 WAY. 5288 03:22:20,360 --> 03:22:24,720 WHAT WE'VE DONE IN THE PAST IS 5289 03:22:24,720 --> 03:22:26,960 PATCH THINGS, STICK IN NEW 5290 03:22:26,960 --> 03:22:27,520 MODULES AS NEEDED. 5291 03:22:27,520 --> 03:22:29,560 WE HAVE A LOT OF LEGACY SYSTEMS 5292 03:22:29,560 --> 03:22:32,120 AND WE'VE DONE THESE COMPLEX 5293 03:22:32,120 --> 03:22:32,880 WORK AROUNDS TO ACCOMMODATE 5294 03:22:32,880 --> 03:22:34,840 ADDING NEW THINGS TO THEM. 5295 03:22:34,840 --> 03:22:36,400 AND AT THIS POINT, WHAT WE WOULD 5296 03:22:36,400 --> 03:22:38,000 LIKE TO KNOW IS HOW TO 5297 03:22:38,000 --> 03:22:39,560 STREAMLINE ALL OF THAT, HOW TO 5298 03:22:39,560 --> 03:22:41,840 MAKE IT MUCH MORE EFFICIENT, HOW 5299 03:22:41,840 --> 03:22:44,400 TO IMPROVE THE USER EXPERIENCE, 5300 03:22:44,400 --> 03:22:46,120 AND ALSO HOW TO POSITION 5301 03:22:46,120 --> 03:22:47,480 OURSELVES AS WE MOVE FORWARD IN 5302 03:22:47,480 --> 03:22:50,880 THE NEXT FIVE TO 10 YEARS. 5303 03:22:50,880 --> 03:22:55,920 SO THAT'S WHERE WE'RE WORKING IN 5304 03:22:55,920 --> 03:22:59,920 COLLABORATION WITH NIAID'S IT 5305 03:22:59,920 --> 03:23:01,000 GROUP, AS WELL AS ODDSET, WHICH 5306 03:23:01,000 --> 03:23:02,960 IS A NEW GROUP THAT DEALS WITH 5307 03:23:02,960 --> 03:23:03,760 DATA SHARING. 5308 03:23:03,760 --> 03:23:08,040 SO WE'RE HOPING WE GET SOMETHING 5309 03:23:08,040 --> 03:23:11,320 USEFUL OUT OF THIS. 5310 03:23:11,320 --> 03:23:12,920 >>IT'S NO SMALL TASK, SO THANK 5311 03:23:12,920 --> 03:23:16,120 YOU FOR AT LEAST SHARING A 5312 03:23:16,120 --> 03:23:16,520 LITTLE ABOUT IT. 5313 03:23:16,520 --> 03:23:17,440 >>THANK YOU. 5314 03:23:17,440 --> 03:23:18,600 MAYBE TWO MORE QUESTIONS AND 5315 03:23:18,600 --> 03:23:19,320 THIN I KNOW CARL HAS SAID 5316 03:23:19,320 --> 03:23:20,320 THERE'S SOMETHING WE NEED TO DO 5317 03:23:20,320 --> 03:23:21,080 BEFORE THE END. 5318 03:23:21,080 --> 03:23:22,880 DR. FRANK. 5319 03:23:22,880 --> 03:23:25,120 >>THANKS, KEN. 5320 03:23:25,120 --> 03:23:27,680 SO TWO-PART QUESTION FOR ANYBODY 5321 03:23:27,680 --> 03:23:30,640 WHO'D LIKE TO ANSWER. 5322 03:23:30,640 --> 03:23:35,040 I WANT TO GO BACK TO SOME OF THE 5323 03:23:35,040 --> 03:23:36,880 SUCCESSES OF THE DELANEY 5324 03:23:36,880 --> 03:23:38,960 COLLABORATORY, AND HIGHLIGHT 5325 03:23:38,960 --> 03:23:42,440 THAT AS A GREAT EXAMPLE OF 5326 03:23:42,440 --> 03:23:44,640 INTERDISCIPLINARY COLLABORATIVE 5327 03:23:44,640 --> 03:23:50,800 SCIENCE, AND I'M WONDERING HOW 5328 03:23:50,800 --> 03:23:54,880 THE GROUP DECIDES WHEN TO PUT 5329 03:23:54,880 --> 03:23:55,920 TOGETHER LIKE BIG COLLABORATIVE 5330 03:23:55,920 --> 03:23:59,680 EFFORTS TO TACKLE PROBLEMS 5331 03:23:59,680 --> 03:24:03,840 VERSUS FUNDING A HANDFUL OF 5332 03:24:03,840 --> 03:24:04,280 R01s. 5333 03:24:04,280 --> 03:24:06,000 HOW DO YOU BALANCE THOSE 5334 03:24:06,000 --> 03:24:07,400 DECISIONS, AND THEN LIKE ON THE 5335 03:24:07,400 --> 03:24:10,320 OTHER SIDE, WE'VE GOT NETWORKS 5336 03:24:10,320 --> 03:24:13,600 LIKE THE HVTN AND THE ACTG THAT 5337 03:24:13,600 --> 03:24:17,000 HAVE FREEZERS FULL OF SPECIMENS 5338 03:24:17,000 --> 03:24:22,240 THAT AREN'T BEING ANALYZED, BUT 5339 03:24:22,240 --> 03:24:23,920 THEREIN PROBABLY LIES SOME 5340 03:24:23,920 --> 03:24:26,120 INTERESTING DATA AND RESULTS. 5341 03:24:26,120 --> 03:24:31,800 SO HOW DO YOU MAYBE BRING SOME 5342 03:24:31,800 --> 03:24:34,120 OF THOSE SPECIMENS OUT FROM THE 5343 03:24:34,120 --> 03:24:35,320 NETWORKS AND MAKE THEM MORE 5344 03:24:35,320 --> 03:24:36,920 ACCESSIBLE TO SCIENTISTS AT 5345 03:24:36,920 --> 03:24:39,280 LARGE? 5346 03:24:39,280 --> 03:24:41,160 >>I'LL TAKE THAT ONE ON. 5347 03:24:41,160 --> 03:24:43,480 >>GOOD. 5348 03:24:43,480 --> 03:24:45,000 >>THAT'S A REALLY IMPORTANT 5349 03:24:45,000 --> 03:24:45,400 QUESTION. 5350 03:24:45,400 --> 03:24:46,400 ONE OF THE FIRST THINGS I DID 5351 03:24:46,400 --> 03:24:48,880 WHEN I GOT TO DAIDS 25 YEARS AGO 5352 03:24:48,880 --> 03:24:50,360 WAS SEE IF WE COULD WORK OUT AN 5353 03:24:50,360 --> 03:24:51,400 AGREEMENT FOR SPECIMEN SHARING 5354 03:24:51,400 --> 03:24:53,280 WITH THE NETWORKS AND THERE 5355 03:24:53,280 --> 03:24:55,400 WAS -- THOSE ARE OUR SPECIMENS. 5356 03:24:55,400 --> 03:24:57,480 YOU CAN'T TOUCH SPECIMENS UNTIL 5357 03:24:57,480 --> 03:24:59,320 THE TRIAL IS OVER. 5358 03:24:59,320 --> 03:25:05,520 SO THERE'S A BARRIER THAT IS 5359 03:25:05,520 --> 03:25:06,920 REAL WITH THAT. 5360 03:25:06,920 --> 03:25:09,120 SPECIMENS ARE AVAILABLE, AND I 5361 03:25:09,120 --> 03:25:12,120 THINK EVERY FIVE OR 10 YEARS WE 5362 03:25:12,120 --> 03:25:13,200 ADVERTISE THAT THESE ARE 5363 03:25:13,200 --> 03:25:17,440 AVAILABLE, NOT JUST IN MAX WISE, 5364 03:25:17,440 --> 03:25:23,280 ACTG, PNN DOEPTN DOES A REALLY B 5365 03:25:23,280 --> 03:25:24,600 MAKING THEIR SPECIMENS AVAILABLE 5366 03:25:24,600 --> 03:25:26,120 AND HAVE -- HAD PROCESSES THAT 5367 03:25:26,120 --> 03:25:26,800 ARE UP AND GOING. 5368 03:25:26,800 --> 03:25:29,520 BUT IN SOME WAYS IT'S PARTLY 5369 03:25:29,520 --> 03:25:33,440 INCUMBENT ON THE NETWORKS TO 5370 03:25:33,440 --> 03:25:39,040 ALSO ADVERTISE THAT THESE 5371 03:25:39,040 --> 03:25:40,720 ACTIVITIES, THESE GEMS ARE 5372 03:25:40,720 --> 03:25:40,960 AVAILABLE. 5373 03:25:40,960 --> 03:25:43,120 SO I THINK WE ALL HAVE A 5374 03:25:43,120 --> 03:25:44,000 RESPONSIBILITY TO DO A BETTER 5375 03:25:44,000 --> 03:25:46,840 JOB OF NOT JUST FOCUSING ON THE 5376 03:25:46,840 --> 03:25:47,280 NEXT. 5377 03:25:47,280 --> 03:25:49,800 WITH REGARD TO THE NOTION OF 5378 03:25:49,800 --> 03:25:52,800 WHAT YOU DECIDE TO COMPETE, LIKE 5379 03:25:52,800 --> 03:25:55,080 THE COLLABORATORIES VERSUS 5380 03:25:55,080 --> 03:25:57,680 R01s, WE'VE HAD R01s IN THE 5381 03:25:57,680 --> 03:26:01,120 CURE SPACE FOR A DECADE OR MORE. 5382 03:26:01,120 --> 03:26:02,640 THEY WERE -- BECAUSE THE PROBLEM 5383 03:26:02,640 --> 03:26:04,480 WAS SO MULTIDISCIPLINARY IN 5384 03:26:04,480 --> 03:26:06,880 TERMS OF THE CHALLENGE, WE FELT 5385 03:26:06,880 --> 03:26:08,680 IT WAS ESSENTIAL TO TRY A NEW 5386 03:26:08,680 --> 03:26:10,840 MODEL. 5387 03:26:10,840 --> 03:26:13,800 THAT WOULD THEN BRING IN A WHOLE 5388 03:26:13,800 --> 03:26:15,600 RANGE OF DIFFERENT PEOPLE. 5389 03:26:15,600 --> 03:26:18,960 IN SOME WAYS THE CHAVIS STARTED 5390 03:26:18,960 --> 03:26:26,120 THAT IN THE VACCINE SPACE 5391 03:26:26,120 --> 03:26:27,840 THAT -- OVER TO THE 5392 03:26:27,840 --> 03:26:28,600 COLLABORATORY AND INTO CURE. 5393 03:26:28,600 --> 03:26:30,600 >>I THINK IT'S BEEN REALLY 5394 03:26:30,600 --> 03:26:31,440 SUCCESSFUL, THE COLLABORATORIES. 5395 03:26:31,440 --> 03:26:32,720 I WOULD URGE YOU TO DO IT MORE 5396 03:26:32,720 --> 03:26:36,640 IN AREAS LIKE AGING AND MAYBE 5397 03:26:36,640 --> 03:26:37,840 CARDIOVASCULAR DISEASE OR, YOU 5398 03:26:37,840 --> 03:26:40,400 KNOW, OTHER IMPORTANT 5399 03:26:40,400 --> 03:26:41,360 COMPLICATIONS IN PEOPLE WITH 5400 03:26:41,360 --> 03:26:41,520 HIV. 5401 03:26:41,520 --> 03:26:43,000 >>I WOULD AGREE WITH THAT. 5402 03:26:43,000 --> 03:26:44,760 THE ISSUE IS, THERE'S SOMETHING 5403 03:26:44,760 --> 03:26:48,160 CALLED A SWIM LANE, AND AGING IS 5404 03:26:48,160 --> 03:26:51,440 NOT MY PRIMARY SWIM LANE, NOR IS 5405 03:26:51,440 --> 03:26:52,400 CARDIOVASCULAR DISEASE. 5406 03:26:52,400 --> 03:26:55,520 I'M MORE THAN HAPPY TO 5407 03:26:55,520 --> 03:26:56,600 COLLABORATE, WE AS A DIVISION, 5408 03:26:56,600 --> 03:26:58,480 WITH THE AGING INSTITUTE AND 5409 03:26:58,480 --> 03:27:01,000 WITH NHLBI TO TACKLE THESE 5410 03:27:01,000 --> 03:27:02,000 QUESTIONS, BUT IT'S GOING TO 5411 03:27:02,000 --> 03:27:04,520 REQUIRE PARTNERSHIP. 5412 03:27:04,520 --> 03:27:06,080 AND MAUREEN TALKED ABOUT THAT 5413 03:27:06,080 --> 03:27:06,840 QUITE A BIT. 5414 03:27:06,840 --> 03:27:09,440 >>AGING IS BECOMING MANY OF OUR 5415 03:27:09,440 --> 03:27:11,760 SWIM LANE, I'M AFRAID, CARL, 5416 03:27:11,760 --> 03:27:11,960 BUT -- 5417 03:27:11,960 --> 03:27:13,240 >>WE'RE LIVING IT, RIGHT, KEN? 5418 03:27:13,240 --> 03:27:14,200 >>WE ARE LIVING IT. 5419 03:27:14,200 --> 03:27:15,680 I KNOW THAT NO ONE NEEDS TO 5420 03:27:15,680 --> 03:27:16,920 CATCH A FLIGHT, AND I REALLY 5421 03:27:16,920 --> 03:27:18,680 DON'T LIKE TO GO OVER, BUT WE'RE 5422 03:27:18,680 --> 03:27:21,680 GOING TO GO OVER BY 3 MINUTES. 5423 03:27:21,680 --> 03:27:23,120 RICH HAS A QUESTION, THEN CARL 5424 03:27:23,120 --> 03:27:24,080 THERE'S ONE MORE THING WE NEED 5425 03:27:24,080 --> 03:27:24,400 TO DO. 5426 03:27:24,400 --> 03:27:27,320 IF YOU DO HAVE A FLIGHT, I'M NOT 5427 03:27:27,320 --> 03:27:29,720 SURE WHY, YOU WEREN'T SUPPOSED 5428 03:27:29,720 --> 03:27:31,560 TO BE IN BETHESDA, BUT ANYWAY, 5429 03:27:31,560 --> 03:27:32,880 RICH AND THEN CARL AND THEN WE 5430 03:27:32,880 --> 03:27:33,400 WILL TIE UP. 5431 03:27:33,400 --> 03:27:35,200 >>I'M GOING TO YIELD THE FLOOR. 5432 03:27:35,200 --> 03:27:37,880 I'VE CHATTED MY QUESTION TO THE 5433 03:27:37,880 --> 03:27:39,200 ONE DAIDS PERSON THAT IS 5434 03:27:39,200 --> 03:27:39,480 RELEVANT. 5435 03:27:39,480 --> 03:27:40,200 >>OH, THANK YOU. 5436 03:27:40,200 --> 03:27:41,840 THANK YOU, RICH. 5437 03:27:41,840 --> 03:27:42,440 CARL, THERE WAS SOMETHING ELSE 5438 03:27:42,440 --> 03:27:43,520 THAT WE NEED TO DO. 5439 03:27:43,520 --> 03:27:43,840 >>RIGHT. 5440 03:27:43,840 --> 03:27:47,720 WE HAVE TO DO ONE MORE EN BLOC 5441 03:27:47,720 --> 03:27:52,360 ACTION, ACCEPTING ALL OF THE 5442 03:27:52,360 --> 03:27:53,520 RECOMMENDATIONS AND THE THINGS 5443 03:27:53,520 --> 03:27:55,520 THAT WE VOTED ON TODAY, WHICH 5444 03:27:55,520 --> 03:27:57,960 PRETTY MUCH IS JUST THE SBIRs, 5445 03:27:57,960 --> 03:28:00,240 SO IF YOU WILL CALL FOR AN EN 5446 03:28:00,240 --> 03:28:02,000 BLOC ACTION TO COVER TODAY'S 5447 03:28:02,000 --> 03:28:02,880 AGENDA, THAT WOULD BE 5448 03:28:02,880 --> 03:28:03,160 SUFFICIENT. 5449 03:28:03,160 --> 03:28:04,880 >>YES, IF WE COULD HAVE AN EN 5450 03:28:04,880 --> 03:28:06,400 BLOC ACTION TO COVER THE AGENDA, 5451 03:28:06,400 --> 03:28:08,720 THAT WOULD BE GREAT. 5452 03:28:08,720 --> 03:28:10,480 I THINK IF SOMEONE COULD APPROVE 5453 03:28:10,480 --> 03:28:11,600 THAT? 5454 03:28:11,600 --> 03:28:13,240 >>SO MOVED. 5455 03:28:13,240 --> 03:28:14,120 >>MOVED. 5456 03:28:14,120 --> 03:28:14,640 >>GREAT. 5457 03:28:14,640 --> 03:28:15,960 OKAY. 5458 03:28:15,960 --> 03:28:17,280 ANYONE OPPOSED? 5459 03:28:17,280 --> 03:28:17,440 NO. 5460 03:28:17,440 --> 03:28:17,720 ALL RIGHT. 5461 03:28:17,720 --> 03:28:19,040 SO THOSE ARE APPROVED. 5462 03:28:19,040 --> 03:28:21,840 LET ME ALSO THANK PAM FOR 5463 03:28:21,840 --> 03:28:23,680 ORGANIZING THIS, AND EVERYONE 5464 03:28:23,680 --> 03:28:26,080 WHO PUT TOGETHER GREAT 5465 03:28:26,080 --> 03:28:27,160 PRESENTATIONS, SO MUCH GREAT 5466 03:28:27,160 --> 03:28:27,400 SCIENCE. 5467 03:28:27,400 --> 03:28:31,760 IT IS REALLY ENCOURAGING FOR 5468 03:28:31,760 --> 03:28:35,160 EVERYONE SO KUDOS TO ALL OF YOU. 5469 03:28:35,160 --> 03:28:36,480 AND APOLOGIES THAT WE'RE A FEW 5470 03:28:36,480 --> 03:28:38,560 MINUTES OVER. 5471 03:28:38,560 --> 03:28:41,360 >>KEN, I THINK I SPEAK FOR 5472 03:28:41,360 --> 03:28:42,880 EVERYBODY THANKING YOU FOR YOUR 5473 03:28:42,880 --> 03:28:45,960 GREAT LEADERSHIP ON THIS 5474 03:28:45,960 --> 03:28:46,240 COMMITTEE. 5475 03:28:46,240 --> 03:28:46,840 >>THANK YOU. 5476 03:28:46,840 --> 03:28:48,440 >>WE WILL MISS YOU, KEN. 5477 03:28:48,440 --> 03:28:48,920 >>YES. 5478 03:28:48,920 --> 03:28:50,040 >>THANK YOU, KEN! 5479 03:28:50,040 --> 03:28:51,440 >>IT'S BEEN A PLEASURE TO WORK 5480 03:28:51,440 --> 03:28:52,800 WITH YOU. 5481 03:28:52,800 --> 03:28:54,560 >>CERTAINLY MY PLEASURE WITH 5482 03:28:54,560 --> 03:28:55,000 EVERYONE. 5483 03:28:55,000 --> 03:28:55,960 AND WE WILL HAVE MANY 5484 03:28:55,960 --> 03:28:57,160 OPPORTUNITIES TO CONTINUE TO 5485 03:28:57,160 --> 03:28:58,400 WORK TOGETHER. 5486 03:28:58,400 --> 03:28:58,840 SO THANKS. 5487 03:28:58,840 --> 00:00:00,000 THANKS TO EVERYONE.