1 00:00:05,205 --> 00:00:06,172 HELLO, EVERYONE AND THANK YOU SO 2 00:00:06,239 --> 00:00:08,708 MUCH FOR BEING THIS AFTERNOON OR 3 00:00:08,775 --> 00:00:09,876 THIS MORNING DEPENDING WHERE IN 4 00:00:09,943 --> 00:00:12,145 THE COUNTRY YOU'RE CALLING IN 5 00:00:12,212 --> 00:00:13,179 FROM. 6 00:00:13,246 --> 00:00:16,750 MY NAME IS EMMA CARPENTER THE 7 00:00:16,816 --> 00:00:19,219 NICHD STAFF COORDINATOR OF THE 8 00:00:19,285 --> 00:00:20,387 PRGLAC WORK GROUP OF THE NICHD 9 00:00:20,453 --> 00:00:20,620 COUNCIL. 10 00:00:20,687 --> 00:00:22,489 I'M LOOKING FORWARD TO DIVING 11 00:00:22,555 --> 00:00:24,090 INTO OUR IMPORTANT WORK THIS 12 00:00:24,157 --> 00:00:26,259 AFTERNOON AT OUR SECOND MEETING 13 00:00:26,326 --> 00:00:27,594 OF THIS WORK GROUP. 14 00:00:27,660 --> 00:00:30,663 BEFORE I INTRODUCE OUR CO-CHAIR 15 00:00:30,730 --> 00:00:32,932 I'D LIKE TO GO OVER A FEW 16 00:00:32,999 --> 00:00:34,734 HOUSEKEEPING ITEMS. 17 00:00:34,801 --> 00:00:36,169 FIRST, TO THE WORKING GROUP 18 00:00:36,236 --> 00:00:36,903 MEMBERS, THANK YOU SO MUCH FOR 19 00:00:36,970 --> 00:00:40,073 JOINING US AND FOR YOUR TIME AND 20 00:00:40,140 --> 00:00:40,607 EFFORT TODAY. 21 00:00:40,673 --> 00:00:42,909 FOR THE DURATION OF YOUR MEETING 22 00:00:42,976 --> 00:00:44,644 IF YOU ARE NOT SPEAKING, PLEASE 23 00:00:44,711 --> 00:00:48,581 KEEP YOUR CAMERA OFF AND 24 00:00:48,648 --> 00:00:49,916 MICROPHONE ON MUTE BUT DURING 25 00:00:49,983 --> 00:00:52,118 THE QUESTION AND ANSWER 26 00:00:52,185 --> 00:00:54,821 SESSIONS, IF YOU ASK A QUESTION 27 00:00:54,888 --> 00:00:58,091 OR COME ON TO COMMENT, PLEASE DO 28 00:00:58,158 --> 00:01:00,260 PUT YOUR CAMERA ON AND TAKE 29 00:01:00,326 --> 00:01:02,395 YOURSELF OFF MUTE AND YOUR ALSO 30 00:01:02,462 --> 00:01:04,731 WELCOME TO USE THE CHAT FEATURE 31 00:01:04,798 --> 00:01:11,738 AT ANY TIME. 32 00:01:11,805 --> 00:01:18,244 THIS IS A PUBLIC MEETING VIA NIH 33 00:01:18,311 --> 00:01:22,515 VIDEOCAST KEEPING VIDEOS OFF 34 00:01:22,582 --> 00:01:24,784 KEEPS IT MORE STREAMLINED AND 35 00:01:24,851 --> 00:01:28,555 SOME HAVE STATED CONFLICT AND WE 36 00:01:28,621 --> 00:01:30,623 DO NOT FEEL THIS WILL 37 00:01:30,690 --> 00:01:31,991 NECESSITATE SOME RECUSING 38 00:01:32,058 --> 00:01:32,459 THEMSELVES FROM THE 39 00:01:32,525 --> 00:01:32,792 CONVERSATION. 40 00:01:32,859 --> 00:01:33,993 WITH ALL OF THAT, I'D LIKE TO 41 00:01:34,060 --> 00:01:36,696 TURN IT OVER TO OUR CO-CHAIRS, 42 00:01:36,763 --> 00:01:37,864 THANK YOU BOTH FOR YOUR 43 00:01:37,931 --> 00:01:39,766 LEADERSHIP. 44 00:01:39,833 --> 00:01:41,167 >> THANK YOU, EMMA. 45 00:01:41,234 --> 00:01:42,769 SO I'LL BEGIN IF WE CAN GO TO 46 00:01:42,836 --> 00:01:44,771 THE NEXT SLIDE. 47 00:01:44,838 --> 00:01:46,706 JUST TO ORIENT OUR WORKING GROUP 48 00:01:46,773 --> 00:01:49,108 MEMBERS AND TO OUR PUBLIC 49 00:01:49,175 --> 00:01:51,110 PARTICIPANTS TO WHERE WE'VE BEEN 50 00:01:51,177 --> 00:01:56,249 IN THIS WORKING GROUP SO FAR. 51 00:01:56,316 --> 00:01:59,118 GO BACK ONE SLIDE. 52 00:01:59,185 --> 00:02:00,386 SO YOU'LL RECALL THE FIRST 53 00:02:00,453 --> 00:02:05,859 MEETING IN NOVEMBER WE REVIEWED 54 00:02:05,925 --> 00:02:08,461 RECOMMENDATIONS 12 AND 13 OF THE 55 00:02:08,528 --> 00:02:09,529 IMPLEMENTATION PLAN FOR PRGLAC 56 00:02:09,596 --> 00:02:10,897 PROVIDED TO CONGRESS. 57 00:02:10,964 --> 00:02:14,234 DURING THAT DISCUSSION, WE 58 00:02:14,300 --> 00:02:16,202 REVIEWED THE RECOMMENDATIONS FOR 59 00:02:16,269 --> 00:02:18,004 THE PROGRESS THAT'S BEEN MADE TO 60 00:02:18,071 --> 00:02:22,809 DATE AS IT RELATES TO PREGNANCY. 61 00:02:22,876 --> 00:02:25,178 YOU'LL SEE WE HAVE PROGRESS MADE 62 00:02:25,245 --> 00:02:26,646 TOWARDS RECOMMENDATION 12. 63 00:02:26,713 --> 00:02:27,514 FOR RECOMMENDATION 13 THERE'S 64 00:02:27,580 --> 00:02:31,584 STILL WORK TO BE DONE BUT WE'RE 65 00:02:31,651 --> 00:02:33,486 MOVING FORWARD AND WE CAN REPORT 66 00:02:33,553 --> 00:02:35,321 THE STATUS OF DATES AS THEY 67 00:02:35,388 --> 00:02:35,788 PERTAIN TO THESE TWO 68 00:02:35,855 --> 00:02:40,326 RECOMMENDATIONS. 69 00:02:40,393 --> 00:02:42,662 WHAT WE DISCOVERED WHEN WE WERE 70 00:02:42,729 --> 00:02:44,397 HAVING THE CONVERSATION 71 00:02:44,464 --> 00:02:45,265 REGARDING RECOMMENDATIONS 12 AND 72 00:02:45,331 --> 00:02:49,469 13 FOR LACTATION, WE ARE FURTHER 73 00:02:49,536 --> 00:02:50,937 BEHIND AND THERE WILL BE 74 00:02:51,004 --> 00:02:52,572 NECESSARY STEPS TO PUT IN PLACE 75 00:02:52,639 --> 00:02:57,310 TO SEE THE RECOMMENDATIONS FULLY 76 00:02:57,377 --> 00:02:58,478 IMPLEMENTED FOR PATIENTS WHO MAY 77 00:02:58,545 --> 00:03:03,983 REQUIRE MEDICATIONS DURING 78 00:03:04,050 --> 00:03:04,384 LACTATION. 79 00:03:04,450 --> 00:03:08,121 JUST TO REVALENCE WHAT THE 80 00:03:08,187 --> 00:03:08,888 INTENTIONS RF THIS WORK GROUP AS 81 00:03:08,955 --> 00:03:11,257 WE CONTINUE OUR ACTIVITIES 82 00:03:11,324 --> 00:03:14,227 THROUGH MAY 2024, THIS IS A WORK 83 00:03:14,294 --> 00:03:19,399 GROUP THAT HAS BEEN PUT IN PLACE 84 00:03:19,465 --> 00:03:21,067 AS A RESULT OF INACTION WHERE 85 00:03:21,134 --> 00:03:24,003 THE COMMITTEE'S INTENTION IS TO 86 00:03:24,070 --> 00:03:25,572 MONITOR AND REPORT ON THESE 87 00:03:25,638 --> 00:03:28,441 IMPLEMENTING GUIDELINES PLACED 88 00:03:28,508 --> 00:03:29,208 IN THE PRGLAC REPORT TO 89 00:03:29,275 --> 00:03:30,543 CONGRESS. 90 00:03:30,610 --> 00:03:33,413 THIS INCLUDES OUR REVIEWING WHAT 91 00:03:33,479 --> 00:03:37,650 PURPOSE HAS BEEN MADE IN REGARDS 92 00:03:37,717 --> 00:03:39,118 TO REGULATIONS, WHAT'S PROCEEDED 93 00:03:39,185 --> 00:03:41,354 IN TERMS OF GUIDANCE THAT'S BEEN 94 00:03:41,421 --> 00:03:41,621 DEVELOPED. 95 00:03:41,688 --> 00:03:43,423 ANY OF THE SOCIETY WORK THAT'S 96 00:03:43,489 --> 00:03:45,024 BEEN DONE. 97 00:03:45,091 --> 00:03:46,392 ANY OF THE PROFESSIONAL WORK 98 00:03:46,459 --> 00:03:48,828 THAT'S BEEN DONE AND ANY OF THE 99 00:03:48,895 --> 00:03:49,796 GOVERNMENT AGENCY WORK THAT'S 100 00:03:49,862 --> 00:03:50,396 BEEN DONE. 101 00:03:50,463 --> 00:03:57,270 OUR INTENTION IS NOT TO CALL 102 00:03:57,337 --> 00:04:03,910 THIS A PRINCIPPRINCIPAL'S REPOR 103 00:04:03,977 --> 00:04:04,744 WILL REQUIRE TIME AND EFFORT FOR 104 00:04:04,811 --> 00:04:07,146 THE RECOMMENDATIONS TO BE FULLY 105 00:04:07,213 --> 00:04:07,413 IMPLEMENT. 106 00:04:07,480 --> 00:04:09,382 OUR TASK SAY DIFFICULT ONE WE 107 00:04:09,449 --> 00:04:11,451 HAVE TO ASK MEMBERS OF CERTAIN 108 00:04:11,517 --> 00:04:12,919 AGENCY TO PROVIDE A LITTLE 109 00:04:12,986 --> 00:04:14,454 INSIGHT INTO WHAT'S HAPPENING 110 00:04:14,520 --> 00:04:14,787 THERE. 111 00:04:14,854 --> 00:04:16,756 THEY CAN'T POSSIBLY REPORT ON 112 00:04:16,823 --> 00:04:18,758 THE EXTENT OR SCOPE OF WORK 113 00:04:18,825 --> 00:04:22,161 THAT'S BEING DONE ACROSS THE 114 00:04:22,228 --> 00:04:23,429 AGENCY SPACE AND IN THE PRIVATE 115 00:04:23,496 --> 00:04:25,064 SECTOR BUT WE ARE ASKING THEM AT 116 00:04:25,131 --> 00:04:27,133 LEAST TO PROVIDE US SOME 117 00:04:27,200 --> 00:04:29,135 INSIGHTS INTO HOW WE'VE BEEN 118 00:04:29,202 --> 00:04:30,870 PROGRESSING SO FAR WITH SPECIFIC 119 00:04:30,937 --> 00:04:36,109 RECOMMENDATIONS. 120 00:04:36,175 --> 00:04:38,911 SO WE DO HAVE VERY SPECIFIC 121 00:04:38,978 --> 00:04:40,613 OBJECTIVES AS A WORK GROUP. 122 00:04:40,680 --> 00:04:43,683 OUR OBJECTIVE IS TO IDENTIFY AND 123 00:04:43,750 --> 00:04:46,419 INVITE SPECIFIC SPEAKERS FROM 124 00:04:46,486 --> 00:04:48,354 RELEVANT FEDERAL AGENCIES OR 125 00:04:48,421 --> 00:04:52,425 ENTITY TO DISCUSS PROGRESS 126 00:04:52,492 --> 00:04:52,759 TODAY. 127 00:04:52,825 --> 00:04:54,360 OUR WORKING GROUP IS ABLE TO 128 00:04:54,427 --> 00:04:55,528 DISCUSS FURTHER WHAT IN ADDITION 129 00:04:55,595 --> 00:04:58,097 MAY BE REQUIRED TO FULLY ACTION 130 00:04:58,164 --> 00:04:58,965 THOSE RECOMMENDATIONS. 131 00:04:59,032 --> 00:05:02,235 ADDITIONALLY, IT'S REALLY 132 00:05:02,301 --> 00:05:04,404 IMPORTANT FOR US TO LOOK AT WHAT 133 00:05:04,470 --> 00:05:06,906 BARRIERS MAY BE IN PLACE OR WHAT 134 00:05:06,973 --> 00:05:10,343 ADDITIONALLY MAYBE NEEDED TO 135 00:05:10,410 --> 00:05:14,847 FULLY RECOGNIZE THE 136 00:05:14,914 --> 00:05:17,350 IMPLEMENTATIONS AND PROVIDE A 137 00:05:17,417 --> 00:05:18,751 REPORT TO CONGRESS. 138 00:05:18,818 --> 00:05:21,788 THIS IS A PRETTY QUICK PROCESS. 139 00:05:21,854 --> 00:05:24,057 WE CAN'T POSSIBLY REVIEW ALL OF 140 00:05:24,123 --> 00:05:25,291 THE POSSIBLE THINGS THAT HAVE 141 00:05:25,358 --> 00:05:26,926 BEEN PUT IN PLACE IN REGARDS TO 142 00:05:26,993 --> 00:05:28,761 THIS RECOMMENDATION BUT WE DO 143 00:05:28,828 --> 00:05:33,766 OUR BEST TO PROVIDE A FLAVOR TO 144 00:05:33,833 --> 00:05:35,134 WHAT IS PROGRESSING. 145 00:05:35,201 --> 00:05:37,070 FROM HERE I'LL TURN THINGS OVER 146 00:05:37,136 --> 00:05:39,305 TO SUE TO PROVIDE THE REST OF 147 00:05:39,372 --> 00:05:39,706 THE INTRODUCTION. 148 00:05:39,772 --> 00:05:40,907 >> THANKS, CHRISTINA. 149 00:05:40,973 --> 00:05:42,909 AS A REFRESHER THE 150 00:05:42,975 --> 00:05:43,743 RECOMMENDATIONS OUR WORKING 151 00:05:43,810 --> 00:05:46,112 GROUP HAS BEEN TASKED WITH 152 00:05:46,179 --> 00:05:49,215 REVIEWING HAVE BEEN GROUPED INTO 153 00:05:49,282 --> 00:05:51,384 FIVE CLUSTERS. 154 00:05:51,451 --> 00:05:54,520 YOU'LL RECALL WE SUCCESSFULLY 155 00:05:54,587 --> 00:05:57,690 REVIEWED OUR CLUSTER D FOLLOWED 156 00:05:57,757 --> 00:05:59,959 BY THE ELEMENT OF THE WORK OF 157 00:06:00,026 --> 00:06:02,095 OUR PROGRESS. 158 00:06:02,161 --> 00:06:03,896 TODAY WE'VE GOT A BIT MORE OF 159 00:06:03,963 --> 00:06:06,099 THE HEAVY LIFT AS WE'LL BE 160 00:06:06,165 --> 00:06:11,738 COVERING CLUSTERS A, E AND C. 161 00:06:11,804 --> 00:06:16,743 CLUSTERS A AND E WILL BE 162 00:06:16,809 --> 00:06:22,248 DISCUSSED IN OUR FIRST SESSION. 163 00:06:22,315 --> 00:06:25,685 THESE INCLUDE RECOMMENDATIONS 2, 164 00:06:25,752 --> 00:06:27,820 8, 9 UNDER THEME OF RESEARCH AND 165 00:06:27,887 --> 00:06:31,691 RESOURCE FUNDING AND ALLOCATION, 166 00:06:31,758 --> 00:06:33,626 PRIORITIZATION PROCESS 167 00:06:33,693 --> 00:06:34,761 DEVELOPMENT AND IMPLEMENT OF 168 00:06:34,827 --> 00:06:36,462 NOVEL STRATEGIES AND 169 00:06:36,529 --> 00:06:38,364 FACILITATION OF COLLABORATION. 170 00:06:38,431 --> 00:06:42,235 AS SUCH THE PLANNING TEAM FELT 171 00:06:42,301 --> 00:06:45,805 THE NICHD CAN OFFER THE MOST 172 00:06:45,872 --> 00:06:47,373 COMPREHENSIVE INSIGHTS AND WE'LL 173 00:06:47,440 --> 00:06:48,908 HEAR FROM THEM IN THE FIRST HOUR 174 00:06:48,975 --> 00:06:50,243 OF MEETING. 175 00:06:50,309 --> 00:06:51,277 IN SESSION TWO WE'RE GOING TO 176 00:06:51,344 --> 00:06:55,548 COVER CLUSTER C. 177 00:06:55,615 --> 00:06:58,751 AND THIS CLUSTER INCLUDES 178 00:06:58,818 --> 00:07:00,820 RECOMMENDATIONS 1,4, 7 AND 10. 179 00:07:00,887 --> 00:07:03,589 AS YOU RECALL FROM YOUR MEETING 180 00:07:03,656 --> 00:07:06,526 THESE RECOMMENDATION CENTER ON 181 00:07:06,592 --> 00:07:08,094 HARMONIZATION, GUIDANCE DOCUMENT 182 00:07:08,161 --> 00:07:11,731 DEVELOPMENT, FDA AUTHORITY, 183 00:07:11,798 --> 00:07:13,499 SPONSOR AUTHORITY AND 184 00:07:13,566 --> 00:07:14,567 CONTINGENCY OF PLANNING. 185 00:07:14,634 --> 00:07:15,768 WE RECOGNIZE THESE 186 00:07:15,835 --> 00:07:16,736 RECOMMENDATIONS TOUCH A NUMBER 187 00:07:16,803 --> 00:07:18,437 OF SECTORS AS CHRISTINA 188 00:07:18,504 --> 00:07:20,239 MENTIONED BUT WITH THE LIMITED 189 00:07:20,306 --> 00:07:22,074 TIME WE HAD WE FELT HEARING FROM 190 00:07:22,141 --> 00:07:23,843 COLLEAGUES AT THE FDA WOULD 191 00:07:23,910 --> 00:07:25,912 AFFORD THE BEST OVERVIEW. 192 00:07:25,978 --> 00:07:26,979 WE'LL BE HEARING FROM THEM 193 00:07:27,046 --> 00:07:27,680 DURING SESSION 2. 194 00:07:27,747 --> 00:07:30,016 NOW, BEFORE WE BEGIN I WANTED TO 195 00:07:30,082 --> 00:07:31,050 BRING YOUR ATTENTION TO THIS 196 00:07:31,117 --> 00:07:32,919 GRAPHIC WHICH YOU SAW AT THE 197 00:07:32,985 --> 00:07:34,353 FIRST MEETING AND CHRISTINA 198 00:07:34,420 --> 00:07:35,454 INTRODUCED AGAIN TODAY WHERE WE 199 00:07:35,521 --> 00:07:37,390 SEE AN OVERVIEW OF ALL THE 200 00:07:37,456 --> 00:07:38,991 RECOMMENDATIONS AND IF YOU 201 00:07:39,058 --> 00:07:41,894 RECALL FROM THE LAST MEETING WE 202 00:07:41,961 --> 00:07:43,162 SUBSEQUENTLY DRILLED TO A 203 00:07:43,229 --> 00:07:45,131 SIMILAR GRAPHIC THAT HAS EACH OF 204 00:07:45,198 --> 00:07:46,732 THE SUB RECOMMENDATIONS. 205 00:07:46,799 --> 00:07:47,934 AND THERE ARE TWO IMPORTANT 206 00:07:48,000 --> 00:07:49,702 NOTES FOR TODAY. 207 00:07:49,769 --> 00:07:52,305 THE FIRST IS THAT WE HAVE TABLED 208 00:07:52,371 --> 00:07:53,472 SELECTED SUB RECOMMENDATIONS FOR 209 00:07:53,539 --> 00:07:56,375 REASONS WE'LL EXPLAIN WHEN WE 210 00:07:56,442 --> 00:07:57,844 GET TO THAT PARTICULAR SECTOR 211 00:07:57,910 --> 00:07:59,045 AND RECOMMENDATION. 212 00:07:59,111 --> 00:08:01,214 INSTEAD OF BLUE AS YOU SEE IT 213 00:08:01,280 --> 00:08:03,015 HERE THEY'LL APPEAR DARK GREEN 214 00:08:03,082 --> 00:08:04,283 AND WILL NOT BE DISCUSSED ON THE 215 00:08:04,350 --> 00:08:06,953 LINE TODAY BUT WE CAN HAVE A 216 00:08:07,019 --> 00:08:09,388 CONVERSATION ABOUT THEM OFFLINE. 217 00:08:09,455 --> 00:08:12,458 THE SECOND IS WE WILL NOT BE 218 00:08:12,525 --> 00:08:13,626 ADJUDICATING COLOR ASSIGNMENTS 219 00:08:13,693 --> 00:08:14,927 TODAY LIKE WE DID IN THE FIRST 220 00:08:14,994 --> 00:08:15,761 MEETING. 221 00:08:15,828 --> 00:08:17,196 WE FELT IT WOULD BE MORE 222 00:08:17,263 --> 00:08:20,366 PRODUCTIVE TO SPEND OUR TIME 223 00:08:20,433 --> 00:08:22,235 DISCUSSING SO OUR PLANNING TEAM 224 00:08:22,301 --> 00:08:24,770 WILL GATHER ALL THE COMMENTS, 225 00:08:24,837 --> 00:08:27,006 WILL WORK OFFLINE TO PREPARE A 226 00:08:27,073 --> 00:08:28,107 SYNTHESIS FOR REVIEW INCLUDING 227 00:08:28,174 --> 00:08:30,142 THE COLOR ASSIGNMENTS AND ASK 228 00:08:30,209 --> 00:08:31,644 YOU GUYS TO REVIEW THAT OFFLINE 229 00:08:31,711 --> 00:08:32,912 AFTER THE MEETING. 230 00:08:32,979 --> 00:08:34,547 I'LL GOING TO GO AHEAD AND STOP 231 00:08:34,614 --> 00:08:35,882 HERE AND SEE IF THERE'S ANY 232 00:08:35,948 --> 00:08:38,084 QUESTIONS CHRISTINA AND I CAN 233 00:08:38,150 --> 00:08:39,285 ANSWER BEFORE WE HEAD INTO 234 00:08:39,352 --> 00:08:49,161 SESSION 1. 235 00:08:49,228 --> 00:08:51,364 I MAY JUST REIT TATE WHILE WE'RE 236 00:08:51,430 --> 00:08:52,698 WAITING TO SEE IF THERE'S 237 00:08:52,765 --> 00:08:53,900 QUESTIONS BECAUSE WE'LL BE 238 00:08:53,966 --> 00:08:56,102 SPENDING MORE TIME TODAY IN 239 00:08:56,168 --> 00:08:57,536 DISCUSSION, MORE TIME TODAY 240 00:08:57,603 --> 00:09:02,241 SUMMARIZING AND COLLATING YOUR 241 00:09:02,308 --> 00:09:03,576 VIEWS AND COMMENTS PLEASE USE 242 00:09:03,643 --> 00:09:05,344 THE MEETING CHAT LIBERALLY. 243 00:09:05,411 --> 00:09:07,346 WE'LL DO OUR BEST TO CONSOLIDATE 244 00:09:07,413 --> 00:09:08,915 AND SYNTHESIS AS WE GO THROUGH 245 00:09:08,981 --> 00:09:10,249 THE MEETING. 246 00:09:10,316 --> 00:09:13,152 I'M NOT SEEING ANY HANDS. 247 00:09:13,219 --> 00:09:15,388 IF THERE ARE NONE I'M GOING TO 248 00:09:15,454 --> 00:09:16,756 TURN OVER TO CHRISTINA TO 249 00:09:16,822 --> 00:09:19,191 MODERATE SESSION 1. 250 00:09:19,258 --> 00:09:20,693 >> WONDERFUL, THANKS SO MUCH, 251 00:09:20,760 --> 00:09:20,860 SUE. 252 00:09:20,927 --> 00:09:23,729 WE'RE PLEASED TO HAVE THE DAY AS 253 00:09:23,796 --> 00:09:25,965 SUE MENTIONED COLLEAGUES FROM 254 00:09:26,032 --> 00:09:26,832 THE INSTITUTES FROM CHILD HEALTH 255 00:09:26,899 --> 00:09:29,802 AND HUMAN DEVELOPMENT. 256 00:09:29,869 --> 00:09:31,504 THERE'S BEEN A NEUTRAL OF 257 00:09:31,570 --> 00:09:32,738 ACTIVITIES GOING ON SINCE THE 258 00:09:32,805 --> 00:09:33,506 RECOMMENDATIONS WERE PUT IN 259 00:09:33,572 --> 00:09:35,775 PLACE AND WE'RE THRILLED TO HAVE 260 00:09:35,841 --> 00:09:44,917 WITH US TODAY DR. NAHIDA 261 00:09:44,984 --> 00:09:50,222 CHAKHTOURA AND AARON PAWLYK AND 262 00:09:50,289 --> 00:09:52,959 CAMILLE FABIYI TALKING ABOUT 263 00:09:53,025 --> 00:09:53,259 DEVELOPMENT. 264 00:09:53,326 --> 00:09:55,428 ONE THING TO REITERATE IS PLEASE 265 00:09:55,494 --> 00:09:58,297 USE THE CHAT FEATURE LIBERALLY 266 00:09:58,364 --> 00:09:59,966 WE'RE DOWNLOADING THE COMMENTS 267 00:10:00,032 --> 00:10:01,667 ONCE MADE AFTER THE MEETING AND 268 00:10:01,734 --> 00:10:03,202 THEY'LL BE IMPORTANT FOR 269 00:10:03,269 --> 00:10:04,637 INFORMING OUR REPORT. 270 00:10:04,704 --> 00:10:07,173 WE ALSO HELPED GUIDE SOME 271 00:10:07,239 --> 00:10:09,075 DISCUSSION THAT WILL TAKE PLACE 272 00:10:09,141 --> 00:10:10,376 AFTERWARDS AND IF WE'RE 273 00:10:10,443 --> 00:10:14,213 PROCEEDING WITH GOOD TIME WE'LL 274 00:10:14,280 --> 00:10:16,649 BE ASKING NAHIDA AND AARON AND 275 00:10:16,716 --> 00:10:18,451 CAMILLE IF THEY CAN ANSWER 276 00:10:18,517 --> 00:10:19,752 CLARIFYING QUESTIONS ONCE 277 00:10:19,819 --> 00:10:20,019 COMPLETED. 278 00:10:20,086 --> 00:10:23,656 WITH THAT WE'LL JUMP IN AND I'D 279 00:10:23,723 --> 00:10:26,525 LIKE TO BRING NAHIDA UP FOR THE 280 00:10:26,592 --> 00:10:27,626 FIRST PRESENTATION FROM NICHD. 281 00:10:27,693 --> 00:10:28,694 >> THANK YOU SO MUCH. 282 00:10:28,761 --> 00:10:29,795 IT'S WONDERFUL TO BE WITH YOU. 283 00:10:29,862 --> 00:10:31,397 I'M SORRY I MISSED THE FIRST 284 00:10:31,464 --> 00:10:34,467 MEETING BUT I'M GLAD TO BE HERE 285 00:10:34,533 --> 00:10:38,237 TODAY TO TALK ABOUT OUR CLINICAL 286 00:10:38,304 --> 00:10:40,206 TRIAL NETWORKS WITHIN MY BRANCH 287 00:10:40,272 --> 00:10:48,848 OF THE PREGNANCY AND PER 288 00:10:48,914 --> 00:10:50,916 PERINATOLOGY BRANCH AND GLAD 289 00:10:50,983 --> 00:10:54,220 MEMBERS OF THE VARIOUS NETWORKS 290 00:10:54,286 --> 00:10:57,923 ARE PART OF THE COMMITTEE. 291 00:10:57,990 --> 00:11:08,467 I WILL TALK ABOUT OUR THREE 292 00:11:16,175 --> 00:11:21,247 NETWORKS, MFMU, NRU AND GN AND 293 00:11:21,313 --> 00:11:22,181 ALL THREE HAVE BEEN AROUND THE 294 00:11:22,248 --> 00:11:27,720 PAST COUPLE DECADES WITH THE 295 00:11:27,787 --> 00:11:30,122 SAME STRUCTURE FOR THAT TIME 296 00:11:30,189 --> 00:11:31,057 PERIOD AND UNTIL RECENTLY WHERE 297 00:11:31,123 --> 00:11:34,226 THE STRUCTURE HAS CHANGED OR 298 00:11:34,293 --> 00:11:40,766 BEEN MODIFIED A BIT NOT ONLY DID 299 00:11:40,833 --> 00:11:42,868 WE INCREASE THE DURATION OF THE 300 00:11:42,935 --> 00:11:45,004 NETWORK FROM FIVE YEARS TO SEVEN 301 00:11:45,071 --> 00:11:50,976 YEARS BUT MODIFIED HOW THE 302 00:11:51,043 --> 00:11:52,778 CLINICAL TRIAL PROCESS RUNS AND 303 00:11:52,845 --> 00:11:56,749 SO WHAT HAS BEEN DONE AND THE 304 00:11:56,816 --> 00:11:58,317 GOAL THE REASON WHY THE CHANGE 305 00:11:58,384 --> 00:12:01,353 HAS OCCURRED IN THE SINCE 2020 306 00:12:01,420 --> 00:12:06,192 IS TO REALLY TRY TO REACH THE 307 00:12:06,258 --> 00:12:07,927 GOALS OR THE GUIDING PRINCIPLES 308 00:12:07,993 --> 00:12:11,564 OF ENHANCING THE RIGOR AND 309 00:12:11,630 --> 00:12:12,932 REPRODUCIBILITY OF CLINICAL 310 00:12:12,998 --> 00:12:18,237 TRIALS, PROMOTING GREATER 311 00:12:18,304 --> 00:12:19,138 AVAILABILITY OF MULTI-SITE 312 00:12:19,205 --> 00:12:19,839 CLINICAL TRIAL INFRASTRUCTURE TO 313 00:12:19,905 --> 00:12:23,075 A WIDE RANGE OF INVESTIGATORS 314 00:12:23,142 --> 00:12:25,444 AND TRY TO FACILITATE DATA 315 00:12:25,511 --> 00:12:28,647 SHARING AND ACCESS TO BIO 316 00:12:28,714 --> 00:12:30,049 SPECIMENS TO EFFICIENTLY EXPAND 317 00:12:30,116 --> 00:12:30,583 RESEARCH CAPACITY FOR ALL 318 00:12:30,649 --> 00:12:37,890 INVESTIGATORS. 319 00:12:37,957 --> 00:12:40,759 TO ALLOW FOR GREATER DIVERSE 320 00:12:40,826 --> 00:12:42,094 POPULATIONS IN MULTI-SITE 321 00:12:42,161 --> 00:12:42,461 CLINICAL TRIAL. 322 00:12:42,528 --> 00:12:45,698 THE LAST YEAR THE NETWORKS WERE 323 00:12:45,764 --> 00:12:46,765 RECOMPETED AND EACH OF THE 324 00:12:46,832 --> 00:12:55,007 NETWORKS WERE RECOMPETED TO 325 00:12:55,074 --> 00:12:57,710 AWARD AN INFRASTRUCTURE WITH A 326 00:12:57,776 --> 00:13:00,246 DETE CENTER AND CLINICAL SITES 327 00:13:00,312 --> 00:13:03,682 AND THE PROTOCOLS OR THE 328 00:13:03,749 --> 00:13:04,783 CLINICAL TRIAL PROTOCOLS WOULD 329 00:13:04,850 --> 00:13:06,218 BE SUBMITTED THROUGH A SEPARATE 330 00:13:06,285 --> 00:13:08,320 GRANT APPLICATION PROCESS. 331 00:13:08,387 --> 00:13:10,122 AND THIS FUNDING OPPORTUNITY WAS 332 00:13:10,189 --> 00:13:16,095 RELEASED IN NOVEMBER OF 2022. 333 00:13:16,162 --> 00:13:18,230 SO ANY QUALIFIED INVESTIGATOR 334 00:13:18,297 --> 00:13:20,399 CAN SUBMIT TO THE PROPOSED 335 00:13:20,466 --> 00:13:21,600 CLINICAL TRIAL. 336 00:13:21,667 --> 00:13:24,136 SO THAT'S ONE OF THE WAYS THAT 337 00:13:24,203 --> 00:13:26,338 THIS WAS MODIFIED FOR THIS 338 00:13:26,405 --> 00:13:31,877 UPCOMING CYCLE AGAIN FROM 2023 339 00:13:31,944 --> 00:13:35,447 TO 2030 THE NETWORK DURATION FOR 340 00:13:35,514 --> 00:13:36,282 THE NEW THREE CLINICAL TRIALS 341 00:13:36,348 --> 00:13:38,250 WITHIN THE NETWORK. 342 00:13:38,317 --> 00:13:40,753 SO I'LL START WITH THE MATERNAL 343 00:13:40,819 --> 00:13:46,158 FETAL MEDICINE UNIT NETWORK. 344 00:13:46,225 --> 00:13:47,960 AGAIN, THE PURPOSE OF THE 345 00:13:48,027 --> 00:13:51,797 NETWORK IS TO REDUCE MATERNAL 346 00:13:51,864 --> 00:13:58,003 FETAL AND INFANT MORTALITY AND 347 00:13:58,070 --> 00:14:01,740 MORE BIT AND MATERNAL 348 00:14:01,807 --> 00:14:03,075 COMPLICATIONS, EXPAND THE 349 00:14:03,142 --> 00:14:04,210 EVIDENCE BASE ABOUT THE SAFETY 350 00:14:04,276 --> 00:14:07,913 AND EFFICACY OF THERAPEUTIC 351 00:14:07,980 --> 00:14:10,249 TREATMENTS USED DURING PREGNANCY 352 00:14:10,316 --> 00:14:12,318 AND LACTATION AND REALLY THE 353 00:14:12,384 --> 00:14:14,720 OBJECTIVE IS TO CONDUCT 354 00:14:14,787 --> 00:14:17,623 DEFINITIVE RIGOROUS AND 355 00:14:17,690 --> 00:14:18,824 REPRODUCIBLE MULTI-SITE CLINICAL 356 00:14:18,891 --> 00:14:20,025 TRIALS AND OBSERVATIONAL STUDIES 357 00:14:20,092 --> 00:14:24,163 IN PREGNANT AND LACTATING PEOPLE 358 00:14:24,230 --> 00:14:24,797 PROVIDING EVIDENCE TO CLINICAL 359 00:14:24,863 --> 00:14:35,040 PRACTICE. 360 00:14:37,076 --> 00:14:39,345 THE CURRENT CLINICAL SITES ARE 361 00:14:39,411 --> 00:14:39,979 GEOGRAPHICALLY DIVERSE ACROSS 362 00:14:40,045 --> 00:14:41,547 THE COUNTRY. 363 00:14:41,614 --> 00:14:46,452 WE HAVE 14 CLINICAL SITES THAT 364 00:14:46,518 --> 00:14:50,222 ENCOMPASSES 27 RECRUITING SITES 365 00:14:50,289 --> 00:14:52,625 WITHIN THOSE AREAS AND AS YOU 366 00:14:52,691 --> 00:14:53,792 CAN NOTE HERE THE TRIALS 367 00:14:53,859 --> 00:14:54,860 COMPLETED WITHIN THE NETWORK 368 00:14:54,927 --> 00:14:57,963 HAVE A HIGH IMPACT ON PRACTICE 369 00:14:58,030 --> 00:15:00,666 WITH OVER 25% OF THE PAPER CITED 370 00:15:00,733 --> 00:15:11,110 IN MEDICAL GUIDELINES. 371 00:15:12,745 --> 00:15:16,815 THESE HAVE BEEN PRODUCTIVE FOR 372 00:15:16,882 --> 00:15:22,888 THE OBSTETRIC COMMUNITY. 373 00:15:22,955 --> 00:15:24,757 ONE OF THE TRIALS COMPLETED AND 374 00:15:24,823 --> 00:15:27,259 I'M NOW GOING TO GO THROUGH THE 375 00:15:27,326 --> 00:15:30,229 YEARS MUCH TRIALS COMPLETED 376 00:15:30,296 --> 00:15:32,031 WITHIN THE NETWORKS TO HIGHLIGHT 377 00:15:32,097 --> 00:15:37,670 SOME EXAMPLES OF WHAT WAS DONE. 378 00:15:37,736 --> 00:15:45,010 ONE IS TRANEXAMIC ACID TO 379 00:15:45,077 --> 00:15:50,115 PREVENT OBSTETRICAL HEMORRHAGE 380 00:15:50,182 --> 00:15:53,485 AFTER CAESAREAN DELIVERY AND 381 00:15:53,552 --> 00:15:55,721 THINKING THERE IT REDUCED THE 382 00:15:55,788 --> 00:15:57,423 BLOOD LOSS AND THERE WAS A 383 00:15:57,489 --> 00:15:59,491 QUESTION IF THE AFFECT IF THAT 384 00:15:59,558 --> 00:16:01,360 REDUCTION REDUCED THE NUMBER OF 385 00:16:01,427 --> 00:16:04,763 BLOOD TRANSFUSIONS OR AFFECTED 386 00:16:04,830 --> 00:16:07,032 SECONDARY OUTCOMES SUCH AS BLOOD 387 00:16:07,099 --> 00:16:10,302 LOSS MORE THAN A LITER 388 00:16:10,369 --> 00:16:11,904 INVENTIONS FROM BLEEDING AND 389 00:16:11,970 --> 00:16:16,775 FURTHER COMPLICATIONS AN 390 00:16:16,842 --> 00:16:20,846 PRE-OPERATIVE OR POST-OPERATIVE 391 00:16:20,913 --> 00:16:26,485 CHANGES TO HEMOGLOBIN AND 392 00:16:26,552 --> 00:16:37,062 COMPLICATIONS AND THERE WAS A 393 00:16:45,971 --> 00:16:47,539 DIFFERENT FROM THE PLACEBO ARM 394 00:16:47,606 --> 00:16:53,746 AND WE NEED OBSTETRICS AND IN 395 00:16:53,812 --> 00:16:55,781 THE POSTPARTUM PERIOD TO PROVIDE 396 00:16:55,848 --> 00:16:58,217 THE EVIDENCE TO CHANGE THE 397 00:16:58,283 --> 00:17:08,594 CLINICAL PRACTICE. 398 00:17:09,595 --> 00:17:12,297 ANOTHER STUDY OF HOW THE 399 00:17:12,364 --> 00:17:13,565 CLINICAL NETWORK STUDIES WERE 400 00:17:13,632 --> 00:17:17,903 LEVERAGED BY OTHER INSTITUTIONS 401 00:17:17,970 --> 00:17:20,339 SUCH AS NHLBI, THE NEW MOMS TO 402 00:17:20,406 --> 00:17:24,076 BE STUDY WHICH RECRUITED 403 00:17:24,143 --> 00:17:28,280 PRIMARILY BY NICHD AND RECRUITED 404 00:17:28,347 --> 00:17:30,916 WOMEN OR INDIVIDUALS WHO HAD 405 00:17:30,983 --> 00:17:32,451 FIRST-PREGNANCIES AND FOLLOWED 406 00:17:32,518 --> 00:17:34,953 THEM PROSPECTIVELY AND THAT 407 00:17:35,020 --> 00:17:41,693 STU 408 00:17:41,760 --> 00:17:42,227 STU 409 00:17:42,294 --> 00:17:46,098 STUDIED BY NHLBI AND LOOKING AT 410 00:17:46,165 --> 00:17:50,502 THE LONG TERM OUTCOMES THAT 411 00:17:50,569 --> 00:17:54,239 DEVELOP AFTER PREGNANCIES AND 412 00:17:54,306 --> 00:17:57,776 ADVERSE OUTCOMES AND A SUBGROUP 413 00:17:57,843 --> 00:17:58,744 OF INDIVIDUALS WITH ANOTHER 414 00:17:58,811 --> 00:18:01,447 GROUP FOLLOWED LOOKING AT 415 00:18:01,513 --> 00:18:02,381 INDIVIDUALS WITH OBSTETRIC SLEEP 416 00:18:02,448 --> 00:18:08,687 APNEA. 417 00:18:08,754 --> 00:18:11,223 NOT ONLY DO THE PRIMARY STUDIES 418 00:18:11,290 --> 00:18:12,524 IMPORTANT TO CLINICAL PRACTICE 419 00:18:12,591 --> 00:18:14,760 BUT ANY SECONDARY STUDIES AS 420 00:18:14,827 --> 00:18:16,728 WELL DONE BASED ON ANY OF THE 421 00:18:16,795 --> 00:18:21,366 CLINICAL TRIALS SO THIS IS AN 422 00:18:21,433 --> 00:18:23,669 EXAMPLE OF THAT AND THEN 423 00:18:23,735 --> 00:18:25,771 HIGHLIGHTING THE NEXT NETWORK 424 00:18:25,838 --> 00:18:30,809 WHICH IS THE GLOBAL NETWORK FOR 425 00:18:30,876 --> 00:18:33,178 WOMEN AND CHILDREN'S HEALTH 426 00:18:33,245 --> 00:18:35,681 RESEARCH TO IMPROVE MATERNAL AND 427 00:18:35,747 --> 00:18:37,716 CHILD SURVIVAL FOCUSSED ON HIGH 428 00:18:37,783 --> 00:18:44,356 NEED AREAS SUCH AS PREVENTING 429 00:18:44,423 --> 00:18:46,825 LIFE-SAVING OBSTETRICAL 430 00:18:46,892 --> 00:18:49,461 INTERVENTIONS FOR PRACTICES AND 431 00:18:49,528 --> 00:18:51,930 IMPROVING BIRTH WEIGHT AND 432 00:18:51,997 --> 00:18:54,266 NUTRITION AND PREVENTING 433 00:18:54,333 --> 00:18:57,069 COMPLICATIONS FROM RURAL AND 434 00:18:57,135 --> 00:18:59,037 PERIURBAN COMMUNITIES GLOBALLY. 435 00:18:59,104 --> 00:19:01,440 THE STRUCTURE FOR THE GLOBAL 436 00:19:01,507 --> 00:19:01,974 NETWORK IS A LITTLE BIT 437 00:19:02,040 --> 00:19:05,477 DIFFERENT THAN THE U.S.-BASED OR 438 00:19:05,544 --> 00:19:13,452 DOMESTIC NETWORKS IN THAT THE 439 00:19:13,519 --> 00:19:18,257 TEAMS WORK TOGETHER WITH 440 00:19:18,323 --> 00:19:20,359 U.S. PARTNERS AND THEY WORK WITH 441 00:19:20,425 --> 00:19:22,261 PEERS AND THE LEAD TEAMS ADDRESS 442 00:19:22,327 --> 00:19:25,030 THE PRIORITIES AND NEEDS OF THE 443 00:19:25,097 --> 00:19:27,833 RESEARCH AREAS IN THE LOW 444 00:19:27,900 --> 00:19:29,935 RESOURCE CENTERS STO FOR 445 00:19:30,002 --> 00:19:32,337 EXAMPLE -- SO FOR FOR EXAMPLE 446 00:19:32,404 --> 00:19:34,406 THE UNIVERSITY OF CAROLINA, CHAP 447 00:19:34,473 --> 00:19:39,344 HEL HILL PARTNERS WITH THE 448 00:19:39,411 --> 00:19:45,384 DEMOCRATIC REPUBLIC OF CONGO TO 449 00:19:45,450 --> 00:19:47,185 DO STUDIES WITHIN THE MATERNAL 450 00:19:47,252 --> 00:19:49,021 NETWORKS AND THE FETAL NETWORK 451 00:19:49,087 --> 00:19:57,029 IN THE SENSE THE NEW STRUCTURE 452 00:19:57,095 --> 00:20:07,639 IS THE SAME AND LOOK AT FUTURE 453 00:20:07,873 --> 00:20:08,407 FOR CLINICAL TRIALS IN THE 454 00:20:08,473 --> 00:20:10,576 NETWORK AND SOME ACTIVITIES AND 455 00:20:10,642 --> 00:20:12,878 THESE ARE SOME OF THE LOCATIONS. 456 00:20:12,945 --> 00:20:16,815 HERE WE HAVE LOCATIONS WITHIN 457 00:20:16,882 --> 00:20:22,120 AFRICA AND ASIA AND THEN THE 458 00:20:22,187 --> 00:20:32,731 U.S. PARTNERS ACROSS THE STATES. 459 00:20:37,636 --> 00:20:40,839 HERE WE HAVE THE PRIVATE PUBLIC 460 00:20:40,906 --> 00:20:43,842 PARTNERSHIPS THROUGH THE 461 00:20:43,909 --> 00:20:47,312 FOUNDATION OF NIH THAT SUPPORTS 462 00:20:47,379 --> 00:20:48,647 THESE TRIALS IN THE GLOBAL 463 00:20:48,714 --> 00:20:51,183 SETTING THE A-PLUS STUDY WAS 464 00:20:51,249 --> 00:20:53,185 SUPPORT THE BILL AND MELINDA 465 00:20:53,251 --> 00:20:56,154 GATES FOUNDATION AND TESTED 466 00:20:56,221 --> 00:21:02,060 WHETHER A SINGLE ORAL 2 GRAM 467 00:21:02,127 --> 00:21:08,100 DOSE OF ANTIBIOTIC OF 468 00:21:08,166 --> 00:21:11,103 AZITHROMYCIN MAY HELP PREVENT 469 00:21:11,169 --> 00:21:13,572 MATERNAL DEATH AND IT WAS ABLE 470 00:21:13,639 --> 00:21:15,841 TO PREVENT SEPSIS AND DEATH BY 471 00:21:15,907 --> 00:21:17,376 ONE-THIRD IN THE STUDY. 472 00:21:17,442 --> 00:21:21,713 IT DID NOT REDUCE STILLBIRTH OR 473 00:21:21,780 --> 00:21:22,814 NEONATAL DEATHS IN THE STUDY. 474 00:21:22,881 --> 00:21:26,284 IT WAS STUDIED FOR EFFICACY ON 475 00:21:26,351 --> 00:21:36,728 THE MATERNAL BENEFIT. 476 00:21:47,272 --> 00:21:49,908 THE SECOND TRIAL IS TO ENROLL 477 00:21:49,975 --> 00:21:56,782 4800 INDIVIDUALS WHO ARE 478 00:21:56,848 --> 00:22:01,286 PREGNANT IN INDIVIDUALS LOOKING 479 00:22:01,353 --> 00:22:03,889 AT INFUSION AT THE TIME OF 480 00:22:03,955 --> 00:22:10,929 DELIVER DLY LOOKING AT ANEMIA A 481 00:22:10,996 --> 00:22:21,173 SIX WEEKS. 482 00:22:32,250 --> 00:22:34,720 MANY STUDIES ARE IN DASH AND THE 483 00:22:34,786 --> 00:22:38,090 NEW MOMS TO BE STUDY IS AN 484 00:22:38,156 --> 00:22:41,960 EXAMPLE AND YOU'LL HEAR MORE HOW 485 00:22:42,027 --> 00:22:46,064 THAT STUDY IS GOING TO BE 486 00:22:46,131 --> 00:22:49,167 LEVERAGED THROUGH THE FNIH. 487 00:22:49,234 --> 00:22:51,436 THIS ENDS MY PRESENTATION. 488 00:22:51,503 --> 00:22:52,804 I'M HAPPY TO TAKE ANY CLARIFYING 489 00:22:52,871 --> 00:22:55,307 QUESTIONS NOW OR LATER BUT THANK 490 00:22:55,373 --> 00:22:56,942 YOU FOR YOUR TIME AND I LOOK 491 00:22:57,008 --> 00:22:57,743 FORWARD TO PARTICIPATING IN THE 492 00:22:57,809 --> 00:23:08,019 DISCUSSIONS. 493 00:23:18,497 --> 00:23:20,699 I THINK WE HAVE TIME FOR 494 00:23:20,766 --> 00:23:21,433 CLARIFYING QUESTIONS IF THERE'S 495 00:23:21,500 --> 00:23:22,601 ONE FROM THE WORKING GROUP. 496 00:23:22,667 --> 00:23:29,341 >> I HAVE A QUESTION, I'M SORRY. 497 00:23:29,407 --> 00:23:31,777 I'M WITH THE AMERICAN COLLEGE OF 498 00:23:31,843 --> 00:23:38,617 OBSTETRICIANS AND GYNECOLOGISS 499 00:23:38,683 --> 00:23:40,352 THIS IS EXCELLENT AND WE'RE BIG 500 00:23:40,418 --> 00:23:41,853 FANS OF THE NETWORKS AND THE 501 00:23:41,920 --> 00:23:43,288 WORK YOU ALL DO. 502 00:23:43,355 --> 00:23:46,792 I'M WONDERING SPECIFICALLY WITH 503 00:23:46,858 --> 00:23:51,496 THE FMNU IF YOU'RE ABLE TO SHARE 504 00:23:51,563 --> 00:23:53,565 WORK THEY'RE DOING SPECIFIC TO 505 00:23:53,632 --> 00:23:53,899 THERAPEUTICS. 506 00:23:53,965 --> 00:23:59,905 I THINK THERE HAS BEEN SOME WORK 507 00:23:59,971 --> 00:24:04,543 THEY'VE DONE AND IT WOULD BE 508 00:24:04,609 --> 00:24:07,979 GREAT TO GET A SENSE OF THAT AND 509 00:24:08,046 --> 00:24:11,283 ANYTHING YOU'D WANT US TO TAKE 510 00:24:11,349 --> 00:24:12,217 AWAY FROM THE CONVERSATION FROM 511 00:24:12,284 --> 00:24:13,885 THAT SPECIFICALLY. 512 00:24:13,952 --> 00:24:16,021 >> SURE. 513 00:24:16,087 --> 00:24:18,256 I'M HAPPY TO PROVIDE -- 514 00:24:18,323 --> 00:24:25,030 >> NAHIDA, THIS IS ALLISON AND I 515 00:24:25,096 --> 00:24:30,268 WANTED TO TAG ON TO RACHEL'S 516 00:24:30,335 --> 00:24:35,140 QUESTIONS AND ASK ABOUT 517 00:24:35,207 --> 00:24:38,710 CONVENTIONAL TAGS. 518 00:24:38,777 --> 00:24:40,779 >> I'M HAPPY TO PROVIDE A LIST 519 00:24:40,846 --> 00:24:41,513 OF THERAPEUTIC TRIALS DONE 520 00:24:41,580 --> 00:24:46,484 THROUGH THE NOETWORK. 521 00:24:46,551 --> 00:24:47,719 THERE'S SEVERAL TRIALS AND I'M 522 00:24:47,786 --> 00:24:48,787 HAPPY TO PROVIDE A LIST AND 523 00:24:48,854 --> 00:24:53,124 SHARE THAT WITH THE WORKING 524 00:24:53,191 --> 00:24:54,426 GROUP. 525 00:24:54,492 --> 00:25:00,232 ONE EXAMPLE WAS THE ACID STUDY 526 00:25:00,298 --> 00:25:01,233 AND I THINK THERE ARE SEVERAL 527 00:25:01,299 --> 00:25:02,901 WITHIN BOTH NETWORKS AND HAPPY 528 00:25:02,968 --> 00:25:04,870 TO PROVIDE A LIST OF ALL THE 529 00:25:04,936 --> 00:25:05,503 THERAPEUTIC TRIALS THAT HAVE 530 00:25:05,570 --> 00:25:16,081 BEEN DONE THROUGH THE NETWORK. 531 00:25:20,619 --> 00:25:22,254 YOU CAN ANSWER QUESTIONS WITHIN 532 00:25:22,320 --> 00:25:23,722 THE CHAT OR POST MEETING AND 533 00:25:23,788 --> 00:25:25,490 WE'LL PROVIDE IT TO THE WORK 534 00:25:25,557 --> 00:25:26,424 GROUP MEMBERS. 535 00:25:26,491 --> 00:25:31,062 THANK YOU. 536 00:25:31,129 --> 00:25:32,063 I SEE A QUESTION. 537 00:25:32,130 --> 00:25:33,632 >> IT'S SOMEWHAT MORE DRILLED 538 00:25:33,698 --> 00:25:39,404 DOWN GIVEN THE FACT THAT WE'RE 539 00:25:39,471 --> 00:25:43,208 CHARGED WITH EVALUATING THE 540 00:25:43,275 --> 00:25:53,818 IMPACT AND IMPLEMENTATION PRGLAC 541 00:25:54,552 --> 00:25:57,088 RECOMMENDATIONS AND MY QUESTION 542 00:25:57,155 --> 00:26:05,330 IS WHAT HAS CHANGED AND HOW HAVE 543 00:26:05,397 --> 00:26:08,533 THESE NETWORKS INCORPORATED THE 544 00:26:08,600 --> 00:26:11,002 RECOMMENDATIONS OF PRGLAC. 545 00:26:11,069 --> 00:26:13,405 HOW WOULD THIS PRESENTATION 546 00:26:13,471 --> 00:26:14,773 LOOKED DIFFERENT PRE-PRGLAC. 547 00:26:14,839 --> 00:26:20,312 >> GREAT QUESTION. 548 00:26:20,378 --> 00:26:24,516 THE MATERNAL MEDICINE NETWORK 549 00:26:24,582 --> 00:26:26,217 HAVE BEEN DEDICATED TO IMPROVING 550 00:26:26,284 --> 00:26:27,686 MATERNAL HEALTH PREPRGLAC AND 551 00:26:27,752 --> 00:26:30,255 WE'VE BEEN AT THE FOR FRONT OF 552 00:26:30,322 --> 00:26:32,324 TRYING TO ANSWER THESE QUESTION 553 00:26:32,390 --> 00:26:34,492 FOR OUR PATIENT POPULATION. 554 00:26:34,559 --> 00:26:36,661 I THINK THAT AND THERE'S BEEN 555 00:26:36,728 --> 00:26:36,995 ROAD BLOCKS. 556 00:26:37,062 --> 00:26:40,465 WE CAN HAVE EXAMPLES OF ROAD 557 00:26:40,532 --> 00:26:42,267 BLOCKS OF GETTING TRIALS DONE 558 00:26:42,334 --> 00:26:44,569 THROUGH THE NETWORKS FOR VARIOUS 559 00:26:44,636 --> 00:26:46,004 REASONS SO WE DO THAT. 560 00:26:46,071 --> 00:26:51,009 WE DO HAVE THAT BUT I THINK IN 561 00:26:51,076 --> 00:26:57,115 GENERAL THE HOPE IS TO CONTINUE 562 00:26:57,182 --> 00:26:58,850 AND WHAT WE'RE HOPING TO DO IS 563 00:26:58,917 --> 00:27:03,655 TRY WITH THE NEW STRUCTURE TO 564 00:27:03,722 --> 00:27:10,261 ADVOCATE FOR MORE CROSS-NETWORK 565 00:27:10,328 --> 00:27:15,100 COLLABORATIONS AND HAVING THE 566 00:27:15,166 --> 00:27:19,838 BIO SPECIMENS SHARED TO GET MORE 567 00:27:19,904 --> 00:27:21,106 INFORMATION FROM THE CLINICAL 568 00:27:21,172 --> 00:27:25,143 TRIAL WE HAVE. 569 00:27:25,210 --> 00:27:28,847 THAT'S PART OF THE REASON WHY 570 00:27:28,913 --> 00:27:31,916 THE WORK DR. POLLACK WILL BE 571 00:27:31,983 --> 00:27:34,252 DISCUSSING AND THE WORK THROUGH 572 00:27:34,319 --> 00:27:39,524 THE FNIH AROUND BIOMARKERS FOR 573 00:27:39,591 --> 00:27:41,559 PREECLAMPSIA BUT LEVERAGING THE 574 00:27:41,626 --> 00:27:43,862 BIO SPECIMENS THROUGH THE 575 00:27:43,928 --> 00:27:47,065 NETWORK AND HAVE BEEN AT THE 576 00:27:47,132 --> 00:27:48,233 FOREFRONT OF DOING WORK IN THIS 577 00:27:48,299 --> 00:27:53,104 POPULATION PREDATING THAT. 578 00:27:53,171 --> 00:27:53,638 >> THANK YOU. 579 00:27:53,705 --> 00:27:57,342 I THINK WE CAN REVISIT THIS 580 00:27:57,409 --> 00:28:00,412 AFTER DR. PAWLYK HAS PRESENTED I 581 00:28:00,478 --> 00:28:02,013 THINK WE'LL HEAR MORE ON THE 582 00:28:02,080 --> 00:28:05,984 WORK AND USE OF DASH. 583 00:28:06,051 --> 00:28:08,053 YOU CAN PUT THE QUESTION IN THE 584 00:28:08,119 --> 00:28:09,587 CHAT AND WE'LL BE SURE TO RETURN 585 00:28:09,654 --> 00:28:12,891 TO BE SURE TO MOVE ON FOR THE 586 00:28:12,957 --> 00:28:13,391 NEXT PRESENTATION FROM 587 00:28:13,458 --> 00:28:14,259 DR. PAWLYK. 588 00:28:14,325 --> 00:28:17,662 >> THANK YOU. 589 00:28:17,729 --> 00:28:19,664 >> I'D LIKE TO INTRODUCE 590 00:28:19,731 --> 00:28:19,964 DR. PAWLYK. 591 00:28:20,031 --> 00:28:21,766 I WANT TO MAKE SURE EVERYONE CAN 592 00:28:21,833 --> 00:28:22,467 HEAR YOU. 593 00:28:22,534 --> 00:28:24,335 >> CAN PEOPLE HEAR ME? 594 00:28:24,402 --> 00:28:29,307 >> PERFECT, THANK YOU SO MUCH. 595 00:28:29,374 --> 00:28:31,409 >> THANK YOU ALL. 596 00:28:31,476 --> 00:28:32,744 I'LL ALSO ADD AS WELL AS MY 597 00:28:32,811 --> 00:28:33,611 PRESENTATION WILL BE GOOD TO 598 00:28:33,678 --> 00:28:35,580 COME BACK TO SOME OF THESE 599 00:28:35,647 --> 00:28:38,483 QUESTIONS AFTER ALL THREE 600 00:28:38,550 --> 00:28:39,918 PRESENTATIONS WHEN DR. FABIYI 601 00:28:39,984 --> 00:28:41,920 PRESENTS ON THE PROCESS WE'RE 602 00:28:41,986 --> 00:28:42,220 UNDERGOING. 603 00:28:42,287 --> 00:28:50,261 THAT CAN INFORM FUTURE 604 00:28:50,328 --> 00:28:58,236 DIRECTIONS. 605 00:28:58,303 --> 00:28:59,938 WE'RE THINKING HOW TO CATALYZE 606 00:29:00,004 --> 00:29:00,705 INNOVATION IN MATERNAL 607 00:29:00,772 --> 00:29:04,843 THERAPEUTICS AND I OFTEN USE 608 00:29:04,909 --> 00:29:06,111 MATERNAL THERAPEUTICS WHEN 609 00:29:06,177 --> 00:29:09,647 REFERRING TO PREGNANCY AND 610 00:29:09,714 --> 00:29:09,948 LACTATION. 611 00:29:10,014 --> 00:29:11,583 WE HAVE A NEW NOVEL NETWORK AND 612 00:29:11,649 --> 00:29:13,184 HAPPY TO SEE SOME INVESTIGATORS 613 00:29:13,251 --> 00:29:14,652 INVOLVED IN THAT ARE ON THE CALL 614 00:29:14,719 --> 00:29:15,987 AS WELL AS WHAT WE'RE DOING AND 615 00:29:16,054 --> 00:29:18,256 POTENTIALLY WHAT WE COULD DO IN 616 00:29:18,323 --> 00:29:22,527 THE FUTURE TO GET TO NOVEL 617 00:29:22,594 --> 00:29:24,429 OBSTETRIC CONDITIONS. 618 00:29:24,496 --> 00:29:26,397 THE NETWORK I WANT TO TALK ABOUT 619 00:29:26,464 --> 00:29:30,268 I WANT TO TALK ABOUT IN 620 00:29:30,335 --> 00:29:32,737 DIFFERENT CONTEXT IS THE MPRINT 621 00:29:32,804 --> 00:29:34,272 HUB WE STARTED TWO AND A HALF 622 00:29:34,339 --> 00:29:35,840 YEARS AGO IS WHEN THE AWARDS 623 00:29:35,907 --> 00:29:40,578 CAME OUT. 624 00:29:40,645 --> 00:29:49,320 THIS IS A NEW IN THE CENTER THIS 625 00:29:49,387 --> 00:29:52,290 IS THE IMPRINT HUB OF THREE 626 00:29:52,357 --> 00:29:53,958 CORES AND CENTERS I'LL DESCRIBE 627 00:29:54,025 --> 00:30:04,469 IN MORE DETAIL AFTERWARDS. 628 00:30:06,037 --> 00:30:08,573 WE WANTED TO WORK WITH DASH TO 629 00:30:08,640 --> 00:30:12,944 START TO DO THIS TO PROVIDE 630 00:30:13,011 --> 00:30:13,978 KNOWLEDGE AND EXPERTISE TO 631 00:30:14,045 --> 00:30:16,714 ENABLE MORE INVESTIGATORS TO 632 00:30:16,781 --> 00:30:17,315 CONDUCT MATERNAL PHARMACOLOGY 633 00:30:17,382 --> 00:30:24,389 AND THERAPEUTICS TRIALS. 634 00:30:24,455 --> 00:30:27,025 WE HAVE FIELD FOR PRECISION 635 00:30:27,091 --> 00:30:30,261 MEDICINE AND BETTER DOSING 636 00:30:30,328 --> 00:30:33,331 WITHIN THE POPULATIONS AND 637 00:30:33,398 --> 00:30:43,908 SYNERGIZE AND PROVIDE THE HUB 638 00:30:45,910 --> 00:30:47,679 CHARGED WITH DOING THAT AS WELL 639 00:30:47,745 --> 00:30:52,884 AS THINGS IN THE PEDIATRIC 640 00:30:52,951 --> 00:30:57,989 NETWORK AND I WANT TO EMPHASIZE 641 00:30:58,056 --> 00:30:59,657 THE MAIN GOALS OF THE CENTERS. 642 00:30:59,724 --> 00:31:06,264 THE FIRST CENTER IS A KRCC AN 643 00:31:06,331 --> 00:31:09,033 AWARD TO INDIANA UNIVERSITY AND 644 00:31:09,100 --> 00:31:09,534 OHIO STATE UNIVERSITY. 645 00:31:09,601 --> 00:31:11,402 THE FIRST COMPONENT IS A 646 00:31:11,469 --> 00:31:13,238 KNOWLEDGE-BASED AND PORTAL CORE 647 00:31:13,304 --> 00:31:15,373 CHARGED WITH INDEXING ALL THE 648 00:31:15,440 --> 00:31:16,908 PUBLICLY AVAILABLE INFORMATION 649 00:31:16,975 --> 00:31:19,777 THAT WE CAN FIND AROUND MATERNAL 650 00:31:19,844 --> 00:31:22,247 AND PEDIATRIC THERAPEUTICS AND I 651 00:31:22,313 --> 00:31:25,850 SHOULD MENTION THIS IS A DUAL 652 00:31:25,917 --> 00:31:27,585 PROJECT SUPPORTED THE BEST 653 00:31:27,652 --> 00:31:28,920 PHARMACEUTICALS FOR CHILDREN ACT 654 00:31:28,987 --> 00:31:31,422 AS WELL AS FUNDS THE NICHD 655 00:31:31,489 --> 00:31:36,094 ALLOCATED TO FOLLOW-UP ON THE 656 00:31:36,160 --> 00:31:40,598 PRGLAC IMPLEMENTATION. 657 00:31:40,665 --> 00:31:45,236 THE KNOWLEDGE BASE AND PORTAL 658 00:31:45,303 --> 00:31:48,072 CORE STARTS UP WITH THIS INTO A 659 00:31:48,139 --> 00:31:50,241 BROADER FRAMEWORK THAT CAN THEN 660 00:31:50,308 --> 00:31:52,910 BE MAPPED TO POSSIBLE ELECTRONIC 661 00:31:52,977 --> 00:31:54,646 HEALTH RECORDS DATA, PHENOTYPE 662 00:31:54,712 --> 00:31:57,815 DATA, DRUG ONTOLOGIES AND GET TO 663 00:31:57,882 --> 00:32:04,856 CATALYZING SO WE KNOW WHAT WE'VE 664 00:32:04,922 --> 00:32:07,725 DONE WE KNOW WHAT WE HAVEN'T 665 00:32:07,792 --> 00:32:09,961 DONE AND THERE'S A REAL-WORLD 666 00:32:10,028 --> 00:32:12,864 EVIDENCE CORE CHARGED USING NEW 667 00:32:12,930 --> 00:32:15,233 APPROACHES AND MOTHER-BABY 668 00:32:15,300 --> 00:32:18,536 LINKAGES FOR COMBINING HEALTH 669 00:32:18,603 --> 00:32:21,239 REPORT DATA AND VARIETY OF DATA 670 00:32:21,306 --> 00:32:24,242 AND PROVIDING A DATA MARK USED 671 00:32:24,309 --> 00:32:25,543 TO CHARACTERIZE MATERNAL AND 672 00:32:25,610 --> 00:32:31,749 PETE -- PEDIATRIC DRAWS AND WHEN 673 00:32:31,816 --> 00:32:32,817 WE TALK ABOUT KNOWLEDGE IT'S 674 00:32:32,884 --> 00:32:34,252 IMPORTANT TO POINT A POINT ON 675 00:32:34,319 --> 00:32:35,853 THAT AND NOT JUST GENERATING 676 00:32:35,920 --> 00:32:36,921 KNOWLEDGE FOR KNOWLEDGE BUT 677 00:32:36,988 --> 00:32:40,858 ANOTHER CORE TAKING THE 678 00:32:40,925 --> 00:32:43,027 KNOWLEDGE AND PUTTING IT INTO 679 00:32:43,094 --> 00:32:46,564 PHARMACO METRIC MODELS AND THESE 680 00:32:46,631 --> 00:32:49,801 ARE PHYSIOLOGIC PHARMACO GENETIC 681 00:32:49,867 --> 00:32:52,603 MODELS WHICH ARE COMPLICATED AND 682 00:32:52,670 --> 00:32:54,172 LOOK AT CHANGES WITH PREGNANCY 683 00:32:54,238 --> 00:32:54,672 AND LACTATION. 684 00:32:54,739 --> 00:32:57,642 THE GOAL IS TO ENABLE MODEL 685 00:32:57,709 --> 00:32:59,377 INFORMED DRUG DEVELOPMENT AND 686 00:32:59,444 --> 00:33:00,478 CLINICAL TRIAL DESIGN TO DO 687 00:33:00,545 --> 00:33:01,879 BETTER DESIGN STUDIES WE THINK 688 00:33:01,946 --> 00:33:04,115 HAVE THE MOST LIKELIHOOD TO 689 00:33:04,182 --> 00:33:04,849 DEMONSTRATE EFFICACY AND BE 690 00:33:04,916 --> 00:33:10,021 SAFE. 691 00:33:10,088 --> 00:33:13,991 S THERE'S OUTREACH AND 692 00:33:14,058 --> 00:33:17,929 DISSEMINATION AND INTERFACE WITH 693 00:33:17,995 --> 00:33:18,429 NETWORKS THAT'S QUITE A 694 00:33:18,496 --> 00:33:22,233 SUBSTANTIAL EFFORT REQUIRED. 695 00:33:22,300 --> 00:33:24,068 THE FIRST CENTER OF EXCELLENCE 696 00:33:24,135 --> 00:33:25,737 AND THERAPEUTICS I'LL DESCRIBE 697 00:33:25,803 --> 00:33:28,873 IS AT THE VANDERBILT UNIVERSITY 698 00:33:28,940 --> 00:33:31,476 LEVERAGING A LOT OF THEIR 699 00:33:31,542 --> 00:33:34,011 EXTENSIVE BIO VIEW AND BIO BANK 700 00:33:34,078 --> 00:33:34,245 DATA. 701 00:33:34,312 --> 00:33:37,115 THE CORE THAT DRIVES ALL THE 702 00:33:37,181 --> 00:33:38,950 PROJECTS THAT ARE UNDERTAKEN 703 00:33:39,016 --> 00:33:41,519 WITHIN THIS PARTICULAR CENTER. 704 00:33:41,586 --> 00:33:45,256 PROJECT 1 FOCUSES ON GENERATING 705 00:33:45,323 --> 00:33:48,059 PHARMACO GENOMICS AND GET 706 00:33:48,126 --> 00:33:50,261 INFORMATION ON THAT IN MATERNAL 707 00:33:50,328 --> 00:33:51,095 AND PEDIATRIC POPULATION. 708 00:33:51,162 --> 00:33:52,830 PROJECT 2 FOCUSES ON MATERNAL 709 00:33:52,897 --> 00:33:55,666 AND NEONATAL OUTCOMES OF 710 00:33:55,733 --> 00:33:57,602 MATERNAL OPIOID USE AND THERE'S 711 00:33:57,668 --> 00:33:59,670 A PRECISION THERAPEUTIC ACADEMY 712 00:33:59,737 --> 00:34:02,940 WHICH SERVES THE ROLE OF 713 00:34:03,007 --> 00:34:03,641 PROVIDING EDUCATION, TEACHING 714 00:34:03,708 --> 00:34:05,276 AND TRAINING LINKED WITH OUR 715 00:34:05,343 --> 00:34:06,244 TRAINING ACTIVITIES ACROSS 716 00:34:06,310 --> 00:34:10,882 NICHD. 717 00:34:10,948 --> 00:34:12,850 THE SECOND CENTER FOR EXCELLENCE 718 00:34:12,917 --> 00:34:16,821 IS AT U.C. SAN DIEGO FOCUSSED ON 719 00:34:16,888 --> 00:34:18,756 ANTIBIOTIC USE AND MOTHERS AN 720 00:34:18,823 --> 00:34:20,825 INFANTS USING A VARIETY OF 721 00:34:20,892 --> 00:34:22,860 APPROACHES THROUGH 722 00:34:22,927 --> 00:34:23,694 COLLABORATIONS SUCH AS WITH THE 723 00:34:23,761 --> 00:34:25,029 PEDIATRIC TRIALS NETWORK. 724 00:34:25,096 --> 00:34:27,198 WE'RE EXTENDING TO ADDITIONAL 725 00:34:27,265 --> 00:34:31,536 DRUG CLASSES SUCH AS 726 00:34:31,602 --> 00:34:31,936 ANTI-DEPRESSANTS. 727 00:34:32,003 --> 00:34:33,538 THIS IS PRIMARILY A MAJOR 728 00:34:33,604 --> 00:34:36,541 PROJECT THE CLINICAL PROJECT 729 00:34:36,607 --> 00:34:37,975 LOOKING AT THE PHARMACO KINETICS 730 00:34:38,042 --> 00:34:40,645 OF ANTIBODIES AND HUMAN MILK AS 731 00:34:40,711 --> 00:34:42,213 WELL AS THE COMPOSITION OF MILK 732 00:34:42,280 --> 00:34:44,782 AND HOW THAT'S ALTERED BY 733 00:34:44,849 --> 00:34:45,917 ANTIBIOTIC INTAKE. 734 00:34:45,983 --> 00:34:48,486 THERE'S A LARGE DATA SCIENCE 735 00:34:48,553 --> 00:34:50,388 PROJECT FOCUSSING ON 736 00:34:50,455 --> 00:34:52,723 METABOLIZING THE METABOLOME IN 737 00:34:52,790 --> 00:34:55,993 HUMAN MILK AS WELL AS INFANTS 738 00:34:56,060 --> 00:34:59,297 LOOKING AT MICROBIOME AND HUMAN 739 00:34:59,363 --> 00:35:01,799 MILK COMPOSITION AND PULLING 740 00:35:01,866 --> 00:35:02,533 THAT TOGETHER. 741 00:35:02,600 --> 00:35:04,068 ANOTHER LARGE PROJECT IS 742 00:35:04,135 --> 00:35:05,236 FOCUSSED ON BASIC SCIENCE MODELS 743 00:35:05,303 --> 00:35:07,371 OF THE EFFECTS WE'RE SEEING IN 744 00:35:07,438 --> 00:35:09,640 TERMS OF DRUG EFFECTS IN ANIMAL 745 00:35:09,707 --> 00:35:10,875 MODELS SO ADDITIONAL WORK THAT 746 00:35:10,942 --> 00:35:14,245 CAN BE DONE YOU JUST CAN'T DO IN 747 00:35:14,312 --> 00:35:14,979 HUMAN POPULATIONS. 748 00:35:15,046 --> 00:35:18,349 AND ALL THIS IS ENABLED BY 749 00:35:18,416 --> 00:35:22,286 ANALYTICAL AND CHEMISTRY CORES 750 00:35:22,353 --> 00:35:23,421 THAT PROVIDE THE ANALYSIS. 751 00:35:23,488 --> 00:35:26,257 I HAVE ALSO MENTIONED HERE 752 00:35:26,324 --> 00:35:27,225 RECENTLY U.C. SAN DIEGO HAS 753 00:35:27,291 --> 00:35:28,826 CREATED WHAT THEY CALL THE HUMAN 754 00:35:28,893 --> 00:35:29,627 MILK INSTITUTE. 755 00:35:29,694 --> 00:35:32,096 I'M NOT GOING TO GO THROUGH ALL 756 00:35:32,163 --> 00:35:34,232 THESE EFFORTS BUT GIVEN THE 757 00:35:34,298 --> 00:35:38,302 CONVERGENCE OF THESE ACTIVITIES 758 00:35:38,369 --> 00:35:39,604 AT U.C. SAN DIEGO THEY OPTED TO 759 00:35:39,670 --> 00:35:42,306 CREATE THE HUMAN MILK INSTITUTE 760 00:35:42,373 --> 00:35:44,375 AND THIS HIGHLIGHTS THE 761 00:35:44,442 --> 00:35:50,248 IMPORTANCE OF HAVING PUB -- HUB 762 00:35:50,314 --> 00:35:51,349 LIKE ACTIVITIES TO BRING 763 00:35:51,415 --> 00:35:52,984 TOGETHER THE ACTIVITIES BEING 764 00:35:53,050 --> 00:35:56,087 SUPPORT OTHER GROUPS. 765 00:35:56,153 --> 00:36:01,893 I WANT TO INTRODUCE THE ONLINE 766 00:36:01,959 --> 00:36:06,230 PERINATAL AND PEDIATRIC 767 00:36:06,297 --> 00:36:09,767 REPOSITORY CHARGED WITH CON 768 00:36:09,834 --> 00:36:10,768 DUCKING LANDSCAPE ASSESSMENT OF 769 00:36:10,835 --> 00:36:12,503 BIO BANKS. 770 00:36:12,570 --> 00:36:14,972 ALL RELATES TO OBSTETRIC 771 00:36:15,039 --> 00:36:16,707 CONDITIONS THAT NAHIDA INDICATED 772 00:36:16,774 --> 00:36:18,242 WERE IN DASH AS WELL AS PRIVATE 773 00:36:18,309 --> 00:36:20,344 COLLECTIONS AND THIS IS QUITE AN 774 00:36:20,411 --> 00:36:21,879 UNDERTAKING TO PULL TOGETHER 775 00:36:21,946 --> 00:36:25,716 WHERE WE ARE WITH EXISTING BIO 776 00:36:25,783 --> 00:36:26,584 SAMPLES AND HOW THESE CAN BE 777 00:36:26,651 --> 00:36:28,819 USED AND INTEGRATED TO SUPPORT 778 00:36:28,886 --> 00:36:39,397 LONG TERM STUDIES AND OUTCOME. 779 00:36:50,174 --> 00:36:52,877 WITH BARDA WE INITIATED A 780 00:36:52,944 --> 00:36:58,983 VACCINE AND MEDICATION STUDY AND 781 00:36:59,050 --> 00:37:06,657 PREGNANCY SURVEILLANCE SYSTEM. 782 00:37:06,724 --> 00:37:09,260 WE'RE LOOKING AT THE PREGNANCY 783 00:37:09,327 --> 00:37:19,737 OUTCOMES FOR MOM AND BABY 784 00:37:19,804 --> 00:37:21,672 VACCINATED OR NOT AND WERE 785 00:37:21,739 --> 00:37:22,940 PLEASED SUPPORT THE STUDY TOE 786 00:37:23,007 --> 00:37:24,375 DEAL WITH EMERGING PANDEMIC. 787 00:37:24,442 --> 00:37:26,243 THE LAST THING I WANT TO 788 00:37:26,310 --> 00:37:29,213 HIGHLIGHT AT THE MPRINT HUB IS 789 00:37:29,280 --> 00:37:30,247 FUNDING OPPORTUNITIES. 790 00:37:30,314 --> 00:37:36,520 THERE'S SOME CURRENTLY AND WE 791 00:37:36,587 --> 00:37:38,689 CANT SEND THOSE AROUND. 792 00:37:38,756 --> 00:37:39,323 THERE'S OPPORTUNITY POOLS AND 793 00:37:39,390 --> 00:37:40,858 EACH HAVE ADDITIONAL FUNDING 794 00:37:40,925 --> 00:37:43,427 POOLS. 795 00:37:43,494 --> 00:37:44,595 THESE ARE ELIGIBLE TO ANYBODY 796 00:37:44,662 --> 00:37:46,230 THAT CAN COME IN AND BE 797 00:37:46,297 --> 00:37:47,264 SUCCESSFUL WITH THOSE. 798 00:37:47,331 --> 00:37:49,967 YOU CAN SEND E-MAIL TO THE 799 00:37:50,034 --> 00:37:53,604 MPRINT HUB FOR MORE INFORMATION. 800 00:37:53,671 --> 00:37:54,805 AFTER THREE YEARS OF THIS 801 00:37:54,872 --> 00:37:55,573 THERE'S BEEN SUCCESS HERE. 802 00:37:55,640 --> 00:37:57,341 QUITE A NUMBER OF AWARDS HAVE 803 00:37:57,408 --> 00:38:00,511 GONE OUT TO CLINICAL FELLOWS AND 804 00:38:00,578 --> 00:38:00,745 POSTDOC. 805 00:38:00,811 --> 00:38:03,681 THE FACULTY AWARDS HAVE GONE TO 806 00:38:03,748 --> 00:38:06,017 MORE JUNIOR FACULTY AND HERE'S A 807 00:38:06,083 --> 00:38:07,685 GOOD SPLIT IN TERMS OF PEDIATRIC 808 00:38:07,752 --> 00:38:11,122 AND PREGNANCY AND LACTATION. 809 00:38:11,188 --> 00:38:12,923 THIS IMAGE HERE SHOWS WHERE THE 810 00:38:12,990 --> 00:38:14,959 FUNDING HAS GONE. 811 00:38:15,026 --> 00:38:17,762 IT'S GOING OUTSIDE THE MPRINT 812 00:38:17,828 --> 00:38:21,699 HUB AND ENABLING JUNIOR FACULTY 813 00:38:21,766 --> 00:38:26,070 AND POSTDOCS AND FELLOWS TO 814 00:38:26,137 --> 00:38:31,709 EXPLORE NEW THINGS IN MATERNAL 815 00:38:31,776 --> 00:38:32,009 PEDIATRICS. 816 00:38:32,076 --> 00:38:34,211 NOW I'LL TALK ABOUT NOVEL 817 00:38:34,278 --> 00:38:34,845 THERAPEUTICS FOR LACTATION 818 00:38:34,912 --> 00:38:36,047 SPECIFIC CONDITIONS AND WHAT 819 00:38:36,113 --> 00:38:37,481 WE'RE DOING AND PERHAPS THINKING 820 00:38:37,548 --> 00:38:40,551 MORE WHAT WE COULD DO. 821 00:38:40,618 --> 00:38:42,019 I'M GOING TO TALK ABOUT 822 00:38:42,086 --> 00:38:43,587 OBSTETRIC CONDITIONS AS AN 823 00:38:43,654 --> 00:38:43,821 EXAMPLE. 824 00:38:43,888 --> 00:38:44,422 I THINK EVERYTHING I'M 825 00:38:44,488 --> 00:38:47,091 DESCRIBING COULD BE APPLIED TO 826 00:38:47,158 --> 00:38:48,959 LACTATION SPECIFIC CONDITIONS. 827 00:38:49,026 --> 00:38:50,327 WE DON'T HAVE AS MUCH AS GOING 828 00:38:50,394 --> 00:38:55,266 ON IN TERMS OF NOVEL DRUGS AND 829 00:38:55,332 --> 00:38:56,434 DISCOVERY FOR THESE CONDITIONS 830 00:38:56,500 --> 00:38:58,002 BUT THE FRAMEWORK CAN APPLY. 831 00:38:58,069 --> 00:39:01,072 I THINK OF THIS AS A 832 00:39:01,138 --> 00:39:03,140 THREE-LEGGED STOOL HAVING 833 00:39:03,207 --> 00:39:04,275 BIOMARKERS FOR PATIENT 834 00:39:04,341 --> 00:39:05,876 STRATIFICATION, SURROGATE 835 00:39:05,943 --> 00:39:07,611 OUTCOMES, DRUG TARGET ENGAGEMENT 836 00:39:07,678 --> 00:39:07,878 ETCETERA. 837 00:39:07,945 --> 00:39:10,147 FOR THE POPULATIONS WE'RE 838 00:39:10,214 --> 00:39:12,983 TALKING ABOUT WE NEED IMPROVED 839 00:39:13,050 --> 00:39:13,951 NON-CLINICAL SAFETY ASSESSMENT 840 00:39:14,018 --> 00:39:15,686 MODELS AND GETTING TO HUMAN DRUG 841 00:39:15,753 --> 00:39:18,355 TARGET VALIDATION IS VERY 842 00:39:18,422 --> 00:39:20,858 IMPORTANT EARLY ON SO WE CAN 843 00:39:20,925 --> 00:39:21,792 KNOW WHICH THERAPEUTIC TO WORK 844 00:39:21,859 --> 00:39:25,863 ON AND FOCUS ON. 845 00:39:25,930 --> 00:39:27,398 NAHIDA MENTIONED THE FOUNDATION 846 00:39:27,465 --> 00:39:30,167 FOR THE NICHD EARLIER BUT WANT 847 00:39:30,234 --> 00:39:31,969 TO MAKE SURE WE REINTRODUCE 848 00:39:32,036 --> 00:39:33,637 THIS. 849 00:39:33,704 --> 00:39:36,040 IT'S A NON-PROFIT ORGANIZATION 850 00:39:36,107 --> 00:39:37,975 CHARTED BY CONGRESS IN 1996 TO 851 00:39:38,042 --> 00:39:40,311 SUPPORT THE MISSION OF THE NIH. 852 00:39:40,377 --> 00:39:42,513 IT'S AN INDEPENDENT NON PROFIT 853 00:39:42,580 --> 00:39:45,216 AND CAN CREATE VARIOUS 854 00:39:45,282 --> 00:39:46,851 PARTNERSHIPS THE NIH CANNOT DO 855 00:39:46,917 --> 00:39:52,857 AS FEDERAL AGENCY AND IT'S 856 00:39:52,923 --> 00:39:55,259 BUILDING BRIDGES TO BREAKTHROUGH 857 00:39:55,326 --> 00:39:58,195 BECAUSE IT TAKES A LOT OF 858 00:39:58,262 --> 00:39:58,696 ORGANIZATION TO DO THIS. 859 00:39:58,763 --> 00:40:01,098 ONE OF THE COMPONENTS OF THE 860 00:40:01,165 --> 00:40:05,469 FOUNDATION FOR THE NIH IS THE 861 00:40:05,536 --> 00:40:06,237 BIOMEDICAL CONSORTIUM. 862 00:40:06,303 --> 00:40:08,706 A GOOD NUMBER OF PROJECTS THAT 863 00:40:08,773 --> 00:40:11,776 HAVE MOVED FORWARD AND FUNDING 864 00:40:11,842 --> 00:40:13,944 FROM MOSTLY PHARMACEUTICAL 865 00:40:14,011 --> 00:40:14,779 INDUSTRY AND DIAGNOSTIC 866 00:40:14,845 --> 00:40:16,847 COMPANIES TO PURSUE THESE. 867 00:40:16,914 --> 00:40:22,253 THE FDA'S INVOLVED IN THIS AND 868 00:40:22,319 --> 00:40:23,888 THERE'S EXPERTISE IN HOW TO GET 869 00:40:23,954 --> 00:40:25,022 BIOMEDICAL QUALIFICATION FROM 870 00:40:25,089 --> 00:40:26,123 THE FDA. 871 00:40:26,190 --> 00:40:35,733 THIS PROJECT IS LAUNCHING SOON 872 00:40:35,800 --> 00:40:41,972 BUT I WAS HAPPY THERE'S A 873 00:40:42,039 --> 00:40:52,116 RETROSPECTIVE STUDY LEVERAGE IN 874 00:40:52,183 --> 00:40:55,219 THE BIO BANKS AND ADDITIONAL 875 00:40:55,286 --> 00:40:55,886 ONES IDENTIFIED. 876 00:40:55,953 --> 00:40:57,421 COMMERCIAL KITS BEING 877 00:40:57,488 --> 00:40:58,355 CONTRIBUTED BY DIAGNOSTIC 878 00:40:58,422 --> 00:40:58,622 COMPANIES. 879 00:40:58,689 --> 00:41:03,694 THEY'RE USED OUTSIDE THE UNITED 880 00:41:03,761 --> 00:41:05,095 STATES THEY'RE NOT AVAILABLE 881 00:41:05,162 --> 00:41:06,130 COMMERCIALLY AS WIDELY IN THE 882 00:41:06,197 --> 00:41:06,664 UNITED STATES. 883 00:41:06,730 --> 00:41:08,365 THEY CAN BE USED IN ACADEMIC 884 00:41:08,432 --> 00:41:11,402 LABS BUT WE WANT TO MAKE THESE 885 00:41:11,468 --> 00:41:14,071 MORE AVAILABLE TO BE USED FOR 886 00:41:14,138 --> 00:41:19,243 SCREENING IN ANY PREGNANT 887 00:41:19,310 --> 00:41:22,012 PERSON. 888 00:41:22,079 --> 00:41:23,547 THE GOAL STO GENERATE DATA THAT 889 00:41:23,614 --> 00:41:25,516 CAN BE USED FOR REGULATORY 890 00:41:25,583 --> 00:41:28,452 FILING BUT WITH THE FDA IN TERMS 891 00:41:28,519 --> 00:41:30,654 OF QUALIFIED BIOMARKERS FOR USE 892 00:41:30,721 --> 00:41:32,623 IN FUTURE DRUG DEVELOPMENT 893 00:41:32,690 --> 00:41:33,924 STUDIED AND CLINICAL TREATMENT 894 00:41:33,991 --> 00:41:35,759 AND HIGH-RISK PATIENT. 895 00:41:35,826 --> 00:41:38,262 WE HAVE MEMBERS FROM THE FDA 896 00:41:38,329 --> 00:41:48,873 INVOLVED TO GET EARLY INPUT ON 897 00:41:50,374 --> 00:41:56,347 THIS IS AN VALUABLE CALCULATOR 898 00:41:56,413 --> 00:42:02,253 TO BE USED FROM THE FETAL 899 00:42:02,319 --> 00:42:03,387 MEDICINE FOUNDATION. 900 00:42:03,454 --> 00:42:10,828 THE BIOMARKERS DO NOT HAVE EARLY 901 00:42:10,895 --> 00:42:17,067 RISK PREDICTION OF PREECLAMPSIA 902 00:42:17,134 --> 00:42:18,435 AND AGAIN IN GETTING FDA 903 00:42:18,502 --> 00:42:19,870 QUALIFICATION WILL ENABLE THE 904 00:42:19,937 --> 00:42:25,776 TOOL TO BE MORE BROADLY UTILIZED 905 00:42:25,843 --> 00:42:27,478 WITHIN THE UNITED STATES. 906 00:42:27,544 --> 00:42:30,214 THIS WILL LAUNCH FEBRUARY SOth 907 00:42:30,281 --> 00:42:33,050 AT THE SOCIETY FOR FETAL 908 00:42:33,117 --> 00:42:35,552 MEDICINE CONFERENCE THERE WILL 909 00:42:35,619 --> 00:42:36,921 BE AN ENVIRONMENT OPTION AND 910 00:42:36,987 --> 00:42:38,989 IT'S A SMALL ROOM SO PLEASE 911 00:42:39,056 --> 00:42:40,858 SHOOT ME AN E-MAIL AND I CAN GET 912 00:42:40,925 --> 00:42:48,766 YOU INVITED. 913 00:42:48,832 --> 00:42:51,201 WE ALSO WANT TO BE FORWARD 914 00:42:51,268 --> 00:42:51,969 THINKING. 915 00:42:52,036 --> 00:42:58,242 ONE COMPONENT WE'RE ABLE TO ADD 916 00:42:58,309 --> 00:43:06,450 TO THE MPRINT HUB IS A BIOMARKER 917 00:43:06,517 --> 00:43:13,390 PLATFORM FOR PLACENTAL OR FETAL 918 00:43:13,457 --> 00:43:13,657 EXOSOMES. 919 00:43:13,724 --> 00:43:23,133 THESE ARE SMALL SPHERES SECRETED 920 00:43:23,200 --> 00:43:25,869 FROM CELLS AND THEY ARE ACTUALLY 921 00:43:25,936 --> 00:43:28,105 REALLY GOOD REPRESENTS OF 922 00:43:28,172 --> 00:43:29,440 PHYSIOLOGICAL STATUS OF THE 923 00:43:29,506 --> 00:43:30,240 ORIGIN CELL. 924 00:43:30,307 --> 00:43:35,379 IN A PREGNANT PERSON'S BLOOD 925 00:43:35,446 --> 00:43:38,716 ROUGHLY 25 TO 30% ARE FROM THE 926 00:43:38,782 --> 00:43:41,285 PLACENTA IN THE THIRD TRIMESTER. 927 00:43:41,352 --> 00:43:46,256 THIS IS A GREAT SOURCE FOR 928 00:43:46,323 --> 00:43:50,561 POTENTIAL BIOMARKERS. 929 00:43:50,627 --> 00:43:54,999 YOU CAN SEE THE TWO GRAPHS ARE 930 00:43:55,065 --> 00:43:55,265 DIFFERENT. 931 00:43:55,332 --> 00:43:57,434 ONE THE PROTEOME YOU LOOK AT ONE 932 00:43:57,501 --> 00:43:59,803 COMPONENT IN NORMAL PREGNANCY IS 933 00:43:59,870 --> 00:44:01,772 DIFFERENT FROM PRE-TERM 934 00:44:01,839 --> 00:44:02,039 PREGNANCY. 935 00:44:02,106 --> 00:44:03,173 THERE'S POTENTIAL NOR 936 00:44:03,240 --> 00:44:03,474 BIOMARKERS. 937 00:44:03,540 --> 00:44:04,041 WE'RE EXCITED TO BE MOVING 938 00:44:04,108 --> 00:44:10,914 FORWARD WITH THAT. 939 00:44:10,981 --> 00:44:13,484 WE'RE HAVING A WORKSHOP COMING 940 00:44:13,550 --> 00:44:20,290 UP TAKING A LOT OF THE BIO 941 00:44:20,357 --> 00:44:21,925 SAMPLES AND DATA AND PUTTING 942 00:44:21,992 --> 00:44:22,760 INTO A KNOWLEDGE RESOURCE AND 943 00:44:22,826 --> 00:44:24,962 DATABASE AND THINKING HOW IT 944 00:44:25,029 --> 00:44:27,664 COULD POTENTIALLY INTERFACE WITH 945 00:44:27,731 --> 00:44:29,666 THE MPRINT KNOWLEDGE BASE DOWN 946 00:44:29,733 --> 00:44:31,301 THE ROAD AS WELL AS ONE I'LL 947 00:44:31,368 --> 00:44:33,203 TALK ABOUT IN A LITTLE BIT. 948 00:44:33,270 --> 00:44:38,509 IT'S CO-ORGANIZED BY NICHD AND 949 00:44:38,575 --> 00:44:42,746 AND OPPTB AND THE FOUNDATION FOR 950 00:44:42,813 --> 00:44:45,416 THE NIH WE'LL BE BRINGING IN 951 00:44:45,482 --> 00:44:47,518 COHORT OWNERS, DIAGNOSTIC 952 00:44:47,584 --> 00:44:48,585 SCIENTISTS AND COMPANIES AND 953 00:44:48,652 --> 00:44:50,954 GETTING TO THE GOAL OF 954 00:44:51,021 --> 00:44:51,922 ADDITIONAL TYPES OF BIOMARKERS 955 00:44:51,989 --> 00:44:53,057 AND HOW TO USE THAT MORE 956 00:44:53,123 --> 00:44:58,896 EFFECTIVELY. 957 00:44:58,962 --> 00:45:02,099 THE WORK SLB IN BETHESDA AND THE 958 00:45:02,166 --> 00:45:03,467 PREJ ADMINISTRATION SITE WILL 959 00:45:03,534 --> 00:45:04,802 COME SOON AND WE'LL DISTRIBUTE 960 00:45:04,868 --> 00:45:06,070 THAT ONCE AVAILABLE IF YOU'D 961 00:45:06,136 --> 00:45:11,208 LIKE TO ATTEND. 962 00:45:11,275 --> 00:45:18,248 THE SECOND LEG OF THE STOOL AND 963 00:45:18,315 --> 00:45:21,785 WE NEW MODELS TO EVALUATE 964 00:45:21,852 --> 00:45:28,092 EFFICACY AND THIS NOT ALL THE 965 00:45:28,158 --> 00:45:30,928 PROJECTS NICHD IS FUNDING BUT 966 00:45:30,994 --> 00:45:33,230 THE FIRST IS USING 967 00:45:33,297 --> 00:45:36,900 MICROPHYSIOLOGICAL SYSTEMS TO 968 00:45:36,967 --> 00:45:38,836 GENERATE MATERNAL-FETAL 969 00:45:38,902 --> 00:45:39,770 INTERFACE ON CHIPS. 970 00:45:39,837 --> 00:45:41,905 THERE'S CONSTRUCTS WITH 971 00:45:41,972 --> 00:45:42,873 DIFFERENT CHAMBERS ON DIFFERENT 972 00:45:42,940 --> 00:45:44,174 CELL TYPES IN THEM. 973 00:45:44,241 --> 00:45:47,711 YOU CAN RUN A FETAL-BLOOD 974 00:45:47,778 --> 00:45:49,980 SURROGATE THROUGH ONE SIDE AND 975 00:45:50,047 --> 00:45:51,815 MATERNAL BLOOD SURROGATE FROM 976 00:45:51,882 --> 00:45:52,683 ANOTHER SIDE AND SEE WHAT'S 977 00:45:52,749 --> 00:45:54,651 MOVING ACROSS THE MEMBRANES. 978 00:45:54,718 --> 00:45:55,619 THAT'S WHAT THEY'RE WORKING TO 979 00:45:55,686 --> 00:45:58,255 DEVELOP AND THIS IS ACTUALLY A 980 00:45:58,322 --> 00:46:00,357 PROJECT WE CO-FUND WITH NCATS 981 00:46:00,424 --> 00:46:02,226 PART OF A LARGER PROGRAM THEY 982 00:46:02,292 --> 00:46:06,463 HAVE. 983 00:46:06,530 --> 00:46:08,832 ANOTHER ONE WE FUND AS A SMALL 984 00:46:08,899 --> 00:46:13,904 BUSINESS BRANCH I'M EXCITED 985 00:46:13,971 --> 00:46:16,740 ABOUT IS BUILDING AN INTERESTING 986 00:46:16,807 --> 00:46:19,510 IN VITRO APPROACH AND 987 00:46:19,576 --> 00:46:21,345 COMPUTATIONAL MODELS FOR THE 988 00:46:21,411 --> 00:46:24,047 PLACENTAL BARRIER TO PREDICT 989 00:46:24,114 --> 00:46:29,086 FETAL EXPOSURE AND TOXICITY. 990 00:46:29,153 --> 00:46:37,327 THERE'S IF YOU WANT THESE CHIPS 991 00:46:37,394 --> 00:46:40,531 TO BE AVAILABLE TO BE USED BY 992 00:46:40,597 --> 00:46:46,236 THE PHARMACEUTICAL INDUSTRY OR 993 00:46:46,303 --> 00:46:48,539 ACADEMIC INVESTIGATORS AND ANY 994 00:46:48,605 --> 00:46:52,843 ADDITIONAL PRODUCT IS THE 995 00:46:52,910 --> 00:46:55,712 ORGANOIDS USED ASSESS 996 00:46:55,779 --> 00:46:56,613 THERAPEUTIC RESPONSE. 997 00:46:56,680 --> 00:47:01,785 THEY FOCUS MORE ON SAFETY 998 00:47:01,852 --> 00:47:02,619 ASSESSMENTS. 999 00:47:02,686 --> 00:47:07,324 LAST 1000 00:47:07,391 --> 00:47:12,596 LASTLY THERE'S A PROGRAM COMMON 1001 00:47:12,663 --> 00:47:18,969 FUND COMPLEMENT-ARIE PROGRAM AND 1002 00:47:19,036 --> 00:47:21,672 TO LOOK AT NEW WAYS TO DO 1003 00:47:21,738 --> 00:47:26,043 PRE-CLINICAL TYPES OF STUDIES. 1004 00:47:26,109 --> 00:47:31,682 NICHD IS EVALUATED ON THE WORK 1005 00:47:31,748 --> 00:47:31,882 GROUP. 1006 00:47:31,949 --> 00:47:35,786 THIS PROGRAM HAS LOOK AT 1007 00:47:35,852 --> 00:47:36,954 REGULATORY POOLS AVAILABLE AND 1008 00:47:37,020 --> 00:47:39,656 WANT TO MAKE SURE PREGNANCY AND 1009 00:47:39,723 --> 00:47:41,391 LACTATION ARE INCLUDED. 1010 00:47:41,458 --> 00:47:44,461 THIS WILL BE PRESENTED AT THE 1011 00:47:44,528 --> 00:47:46,496 COUNCIL'S COUNCIL NEXT WEEK AND 1012 00:47:46,563 --> 00:47:48,999 GET INPUT AND SEE WHERE IT GOES 1013 00:47:49,066 --> 00:47:49,600 FROM THERE. 1014 00:47:49,666 --> 00:47:51,034 LASTLY, I WANT TO TALK ABOUT 1015 00:47:51,101 --> 00:48:01,511 DRUG TARGET VALIDATION. 1016 00:48:08,285 --> 00:48:12,289 I WANTED TO TALK ABOUT OUR 1017 00:48:12,356 --> 00:48:13,657 PROGRAMS SEEN AS THE AMERICA'S 1018 00:48:13,724 --> 00:48:18,829 SEED FUND TO TRANSLATE IDEAS 1019 00:48:18,895 --> 00:48:26,670 INTO LACKS OF LABLTHS -- INTO 1020 00:48:26,737 --> 00:48:30,240 INTO LARGER COMPANIES AND 1021 00:48:30,307 --> 00:48:36,113 LOOKING AT PRE-TERM BIRTH AND A 1022 00:48:36,179 --> 00:48:43,720 THERAPEUTIC FOR HYPERMESIS AND 1023 00:48:43,787 --> 00:48:46,123 LOOKING AT PREECLAMPSIA AND 1024 00:48:46,189 --> 00:48:47,524 LOOKING MORE BROADLY AND I WANT 1025 00:48:47,591 --> 00:48:51,461 TO BRING UP THE FOUNDATION FOR 1026 00:48:51,528 --> 00:48:52,863 THE ACCELERATING MEDICINE 1027 00:48:52,929 --> 00:48:53,730 PARTNERSHIP PROGRAM STARTED IN 1028 00:48:53,797 --> 00:48:58,869 2014 WITH THE IDEA OF UNITING 1029 00:48:58,935 --> 00:49:00,203 RESOURCES TO UNDERSTAND DISEASE 1030 00:49:00,270 --> 00:49:04,875 PATHWAYS AND GET TO NEW TARGETS 1031 00:49:04,941 --> 00:49:05,542 AND BIOMARKERS. 1032 00:49:05,609 --> 00:49:10,847 THERE'S BEEN A VARIETY OF 1033 00:49:10,914 --> 00:49:21,458 PROGRAMS AND TO SUM THIS UP IT'S 1034 00:49:24,628 --> 00:49:26,229 A PYRAMID WHERE WE HAVE 1035 00:49:26,296 --> 00:49:28,699 REPOSITORIES AND DATA AND FUELS 1036 00:49:28,765 --> 00:49:31,568 AND ALGORITHMS THROUGH OTHER 1037 00:49:31,635 --> 00:49:33,403 PROJECTS AND KNOWLEDGE PORTALS 1038 00:49:33,470 --> 00:49:35,172 TO ACCESS THEM AND IDENTIFY 1039 00:49:35,238 --> 00:49:38,241 POTENTIAL DRUG TARGETS AND 1040 00:49:38,308 --> 00:49:47,851 BIOMARKERS. 1041 00:49:47,918 --> 00:49:50,320 ONE IS THE HUGE AMP USING HUMAN 1042 00:49:50,387 --> 00:49:54,391 GENETICS AS THE FOUNDATION FOR 1043 00:49:54,458 --> 00:49:56,893 THIS GETTING TO THE HUMAN-BASED 1044 00:49:56,960 --> 00:49:59,129 DRUG TARGET VALIDATION. 1045 00:49:59,196 --> 00:50:02,532 THEY WERE ABLE TO GET A 1046 00:50:02,599 --> 00:50:03,367 REPRODUCTIVE SYSTEM PORTAL 1047 00:50:03,433 --> 00:50:06,236 BRINGING IN DATA AND GET TO 1048 00:50:06,303 --> 00:50:07,537 EFFECTER GENES THAT MAY SERVE AS 1049 00:50:07,604 --> 00:50:10,073 DRUG TARGETS, BIOMARKERS OR 1050 00:50:10,140 --> 00:50:11,408 DISEASE INSIGHTS. 1051 00:50:11,475 --> 00:50:13,143 I'M HAPPY TO TAKE ANY QUESTIONS 1052 00:50:13,210 --> 00:50:16,847 NOW OR AFTER THE NEXT TALK. 1053 00:50:16,913 --> 00:50:23,553 THANK YOU ALL. 1054 00:50:23,620 --> 00:50:27,758 >> THANK YOU FOR TAKING US ON 1055 00:50:27,824 --> 00:50:29,159 THE WHIRLWIND PIECES OF WHAT IS 1056 00:50:29,226 --> 00:50:30,861 BEING DONE THROUGH YOUR BRANCH. 1057 00:50:30,927 --> 00:50:34,631 I WANTED TO LEAVE ROOM FOR ONE 1058 00:50:34,698 --> 00:50:35,766 CLARIFICATION QUESTION TO GET 1059 00:50:35,832 --> 00:50:41,338 TON -- ON TO CAMILLE'S 1060 00:50:41,405 --> 00:50:42,973 PRESENTATION AND THERE'S A 1061 00:50:43,039 --> 00:50:44,107 QUESTION IN THE CHAT BUT MORE 1062 00:50:44,174 --> 00:50:46,243 SUITED TO THE DISCUSSION SO 1063 00:50:46,309 --> 00:50:56,820 ANYTHING NOR AARON RIGHT NOW? 1064 00:51:03,527 --> 00:51:05,495 HEARING NOTHING AND GOING TO YOU 1065 00:51:05,562 --> 00:51:06,830 CAMILLE AND WANT TO MAKE SURE 1066 00:51:06,897 --> 00:51:14,037 EVERYONE CAN HEAR YOU CLEARLY. 1067 00:51:14,104 --> 00:51:17,407 CAN YOU SEE AND HEAR ME? 1068 00:51:17,474 --> 00:51:18,041 >> PERFECTLY. 1069 00:51:18,108 --> 00:51:20,110 >> GOOD AFTERNOON. 1070 00:51:20,177 --> 00:51:22,312 I'M A PROGRAM OFFICER WITHIN THE 1071 00:51:22,379 --> 00:51:31,621 OBSTETRIC AND PEDIATRIC BRANCH 1072 00:51:31,688 --> 00:51:33,390 AND PLEASED TO TALK ABOUT THE 1073 00:51:33,457 --> 00:51:35,025 DRUG, VACCINE AND DIETARY 1074 00:51:35,091 --> 00:51:37,093 SUPPLEMENT RESEARCH NEEDS FOR 1075 00:51:37,160 --> 00:51:43,066 PREGNANT, POSTPARTUM AND 1076 00:51:43,133 --> 00:51:44,234 LACTATING PERSONS. 1077 00:51:44,301 --> 00:51:50,607 SO THIS RECOMMENDATION 8B AND 9A 1078 00:51:50,674 --> 00:51:51,808 OF THE IMPLEMENTATION PLAN 1079 00:51:51,875 --> 00:51:55,779 CALLED FOR THE DEVELOPMENT AND 1080 00:51:55,846 --> 00:51:58,081 CREATION OF SEPARATE PROCESSES 1081 00:51:58,148 --> 00:51:59,583 FOR THERAPIES AND CONDITIONS IN 1082 00:51:59,649 --> 00:52:04,221 LACTATING WOMEN AND THE GUIDANCE 1083 00:52:04,287 --> 00:52:10,527 ALSO RECOMMENDED USING NIH'S 1084 00:52:10,594 --> 00:52:13,296 BCCA OR BEST PHARMACEUTICALS 1085 00:52:13,363 --> 00:52:15,699 FOR CHILDREN ACT AS A MODEL. 1086 00:52:15,765 --> 00:52:26,476 THE STEPS OUTLINE D AND THE PLA 1087 00:52:26,910 --> 00:52:32,082 HAVE REQUEST FOR INFORMATION 1088 00:52:32,148 --> 00:52:38,488 ABOUT DESCRIBING NICHD HAD 1089 00:52:38,555 --> 00:52:39,723 NOMINATIONS FOR DRUG AND 1090 00:52:39,789 --> 00:52:40,624 VACCINES AND NEEDS TO BE 1091 00:52:40,690 --> 00:52:44,060 CONSIDERED IN THE DEVELOPMENT OF 1092 00:52:44,127 --> 00:52:48,031 A PRIORITY LIST ON DRUGS, 1093 00:52:48,098 --> 00:52:50,166 VACCINES AND DIETARY RESEARCH 1094 00:52:50,233 --> 00:52:54,237 NEEDS FOR PREGNANT AND 1095 00:52:54,304 --> 00:52:55,872 POSTPARTUM PERSONS PUBLISHED ON 1096 00:52:55,939 --> 00:52:56,640 MAY 8. 1097 00:52:56,706 --> 00:53:01,645 WE WERE SEEING THEM THROUGH THE 1098 00:53:01,711 --> 00:53:05,682 END OF SEPTEMBER PUBLISHED IN 1099 00:53:05,749 --> 00:53:06,783 THE NIH GUIDE AND FEDERAL 1100 00:53:06,850 --> 00:53:11,054 REGISTER AND THE LINK ARE SHOWN 1101 00:53:11,121 --> 00:53:19,262 ON TO THE SLIDE BELOW. 1102 00:53:19,329 --> 00:53:21,131 WE WERE HAPPY TO PROVIDE THE 1103 00:53:21,197 --> 00:53:21,698 NOMINATIONS AND PROVIDE AN 1104 00:53:21,765 --> 00:53:31,241 OVERVIEW OF THE RISKS. 1105 00:53:31,308 --> 00:53:33,376 THIS SHOWS THE NUMBER OF 1106 00:53:33,443 --> 00:53:38,481 NOMINATION BY NOMINATION TYPE ON 1107 00:53:38,548 --> 00:53:45,522 THE LEFT AND MOST THE 1108 00:53:45,589 --> 00:53:50,160 NOMINATIONS WERE FOR DRUGS OF 1109 00:53:50,226 --> 00:53:58,868 THE 136, 114 FOR DRUGS AND TWO 1110 00:53:58,935 --> 00:54:02,939 NOMINATIONS FOR VACCINES MOST 1111 00:54:03,006 --> 00:54:06,443 NOMINATIONS RECEIVED WERE FOR 1112 00:54:06,509 --> 00:54:08,111 GENERAL MEDICAL CONDITIONS SO 1113 00:54:08,178 --> 00:54:14,384 THAT'S PRIMARILY CONSISTED OF 1114 00:54:14,451 --> 00:54:15,819 PREEXISTING MEDICAL CONDITIONS 1115 00:54:15,885 --> 00:54:19,422 OF THE NOMINATIONS, 79 WERE FOR 1116 00:54:19,489 --> 00:54:24,694 GENERAL MEDICAL CONDITIONS 1117 00:54:24,761 --> 00:54:29,966 FOLLOWED BY 35 FOR PREGNANCY OR 1118 00:54:30,033 --> 00:54:30,934 POSTPARTUM AND 22 FOR LACTATION 1119 00:54:31,001 --> 00:54:41,044 SPECIFIC CONDITIONS. 1120 00:54:41,111 --> 00:54:46,282 THE TOP 10 THERAPEUTIC AREAS 1121 00:54:46,349 --> 00:54:51,354 INCLUDED MENTAL HEALTH RELATED 1122 00:54:51,421 --> 00:54:53,390 CONDITIONS AND INFECTIOUS 1123 00:54:53,456 --> 00:54:55,792 DISEASES AND PRETERM BIRTH, 1124 00:54:55,859 --> 00:54:57,193 ASTHMA AND CARDIOVASCULAR 1125 00:54:57,260 --> 00:54:59,195 DISEASE TO ROUND OFF THE TOP 1126 00:54:59,262 --> 00:55:02,232 FIVE FOLLOWED BY HYPERTENSIVE 1127 00:55:02,298 --> 00:55:05,068 DISORDERS. 1128 00:55:05,135 --> 00:55:07,871 FILL BEING SUPPLY ISSUES AND 1129 00:55:07,937 --> 00:55:08,838 SLEEP CIRCADIAN DISORDERS AND 1130 00:55:08,905 --> 00:55:19,282 DIABETES AND OBESITY. 1131 00:55:28,958 --> 00:55:31,428 AND EARLY IN OUR PROCESS IN THE 1132 00:55:31,494 --> 00:55:36,733 FALL WE TOOK THE TIME AFTER THE 1133 00:55:36,800 --> 00:55:37,967 PUBLIC COMMENT PERIOD WE EXPIRED 1134 00:55:38,034 --> 00:55:45,375 WE COLLATE THE NOMINATIONS WE'RE 1135 00:55:45,442 --> 00:55:47,811 BEGINNING AN INTERNAL REVIEW OF 1136 00:55:47,877 --> 00:55:51,815 NOMINATIONS WITH OUR COLLEAGUES 1137 00:55:51,881 --> 00:55:54,951 AROUND NIH WITH THAT WILL TAKE 1138 00:55:55,018 --> 00:55:58,054 US INTO THE END OF NEXT MONTH 1139 00:55:58,121 --> 00:56:01,825 AND LATER THIS YEAR WE PLAN TO 1140 00:56:01,891 --> 00:56:05,562 CONVENE AN EXTERNAL STAKEHOLDER 1141 00:56:05,628 --> 00:56:09,833 MEETING TO DISCUSS THE INITIAL 1142 00:56:09,899 --> 00:56:11,434 NOMINATION LIST AND GOING INTO 1143 00:56:11,501 --> 00:56:13,169 EARLY NEXT YEAR WE PLAN ON 1144 00:56:13,236 --> 00:56:15,939 GATHERING INPUT FROM 1145 00:56:16,005 --> 00:56:17,440 STAKEHOLDERS ON THE PRELIMINARY 1146 00:56:17,507 --> 00:56:22,278 LIST OF VACCINE AND RESEARCH 1147 00:56:22,345 --> 00:56:25,081 TEAMS AND MID TO LATE PART OF 1148 00:56:25,148 --> 00:56:28,384 NEXT YEAR NICHD WILL COORDINATE 1149 00:56:28,451 --> 00:56:29,285 FINALIZATION PUBLICATION OF THAT 1150 00:56:29,352 --> 00:56:31,154 INITIAL PRIORITY LIST. 1151 00:56:31,221 --> 00:56:34,224 THAT IS REALLY OUR PROCESS AND I 1152 00:56:34,290 --> 00:56:38,228 AM HAPPY TO ENTERTAIN QUESTIONS. 1153 00:56:38,294 --> 00:56:43,600 THANK YOU FOR YOUR ATTENTION. 1154 00:56:43,666 --> 00:56:45,735 >> THANK YOU FOR WALKING THROUGH 1155 00:56:45,802 --> 00:56:48,304 THE PRIORITIZATION. 1156 00:56:48,371 --> 00:56:50,240 HAVE THERE CLARIFICATION 1157 00:56:50,306 --> 00:56:51,441 QUESTION FOR CAMILLE BEFORE WE 1158 00:56:51,508 --> 00:56:52,642 OPEN THE CONVERSATION FOR A 1159 00:56:52,709 --> 00:56:53,777 BROADER DISCUSSION. 1160 00:56:53,843 --> 00:56:57,480 >> THAT'S A LONG TIME LINE OUT. 1161 00:56:57,547 --> 00:57:00,183 WHAT HAS BEEN THE NEXT STEP 1162 00:57:00,250 --> 00:57:02,118 AFTER THAT? 1163 00:57:02,185 --> 00:57:04,854 YOU HAVE PRIORITY THINGS THEN 1164 00:57:04,921 --> 00:57:11,060 WHAT? 1165 00:57:11,127 --> 00:57:13,596 >> AFTER THE INITIAL PRIORITY 1166 00:57:13,663 --> 00:57:15,765 LIST IN 2025? 1167 00:57:15,832 --> 00:57:17,066 >> MM-HMM. 1168 00:57:17,133 --> 00:57:20,670 >> IT WILL ULTIMATELY HELP SHAPE 1169 00:57:20,737 --> 00:57:24,741 THE FUNDING OPPORTUNITIES NIH 1170 00:57:24,808 --> 00:57:25,375 MAY DEVELOP. 1171 00:57:25,441 --> 00:57:26,843 THAT'S THE END GAME FOR WHAT WE 1172 00:57:26,910 --> 00:57:27,310 PLAN TO DO WITH THAT 1173 00:57:27,377 --> 00:57:29,379 INFORMATION. 1174 00:57:29,445 --> 00:57:30,180 >> PERFECT, THANK YOU. 1175 00:57:30,246 --> 00:57:33,283 >> SURE. 1176 00:57:33,349 --> 00:57:41,691 THANKS FOR YOUR QUESTION. 1177 00:57:41,758 --> 00:57:42,926 >> ANY CLARIFICATION QUESTIONS 1178 00:57:42,992 --> 00:57:53,503 BEFORE WE OPEN THE DISCUSSION? 1179 00:57:57,440 --> 00:58:00,877 HEARING NONE AND AFTER A SNIES 1180 00:58:00,944 --> 00:58:02,779 AWKWARD PAUSE I'LL INVITE 1181 00:58:02,846 --> 00:58:05,582 CAMILLE AND AARON AND NAHIDA TO 1182 00:58:05,648 --> 00:58:06,883 COME BACK ON CAMERA. 1183 00:58:06,950 --> 00:58:08,251 I THINK WE'LL OPEN THE 1184 00:58:08,318 --> 00:58:08,785 CONVERSATION TO BROADER 1185 00:58:08,852 --> 00:58:10,653 DISCUSSION BUT BEFORE WE DO 1186 00:58:10,720 --> 00:58:12,989 THAT, IF WE COULD PLEASE BRING 1187 00:58:13,056 --> 00:58:15,692 UP THE SLIDES FROM THE DECK ON 1188 00:58:15,758 --> 00:58:18,228 SESSION 1 SO I CAN REMIND 1189 00:58:18,294 --> 00:58:22,198 EVERYONE WHERE WE'LL BE FOCUS 1190 00:58:22,265 --> 00:58:32,809 ING -- AND WE'VE BEEN DISCUSSING 1191 00:58:36,913 --> 00:58:40,516 RECOMMENDATIONS 2,8, 9 AND 11 ON 1192 00:58:40,583 --> 00:58:45,255 CLINICAL AND BASIC SCIENCE 1193 00:58:45,321 --> 00:58:45,622 RESEARCH. 1194 00:58:45,688 --> 00:58:54,197 IF YOU CAN AND INCREASE THE 1195 00:58:54,264 --> 00:58:56,733 QUALITY, TIMELY AND QUANT AND 1196 00:58:56,799 --> 00:58:58,635 TIMELINESS OF RESEARCH ON SAFETY 1197 00:58:58,701 --> 00:59:00,637 AND EFFICACY AND PRODUCTS USED 1198 00:59:00,703 --> 00:59:03,039 BY PREGNANT WOMEN AND LACTATING 1199 00:59:03,106 --> 00:59:04,641 WOMEN AND THERE'S DISCUSSION ON 1200 00:59:04,707 --> 00:59:06,476 AWARDS PERIOD. 1201 00:59:06,542 --> 00:59:10,013 GOING TO RECOMMENDATION 8, 1202 00:59:10,079 --> 00:59:11,047 YOU'LL RECALL FROM OUR MEMO FROM 1203 00:59:11,114 --> 00:59:16,853 THE WORKING GROUP MEMBERS IT 1204 00:59:16,920 --> 00:59:19,555 SPECIFICALLY IS CALLING FOR A 1205 00:59:19,622 --> 00:59:22,225 PROCESS SIMILAR TO THE AGENCY 1206 00:59:22,292 --> 00:59:25,028 PROCESS AS A MODEL FOR THOSE 1207 00:59:25,094 --> 00:59:27,230 THAT AREN'T FAMILIAR IT'S A 1208 00:59:27,297 --> 00:59:31,401 LEGISLATIVE VEHICLE TO SIMULATE 1209 00:59:31,467 --> 00:59:35,238 DEVELOPMENT WHEREBY NIH HAS THE 1210 00:59:35,305 --> 00:59:37,307 ABILITY TO PUT OUT FOR THERE TO 1211 00:59:37,373 --> 00:59:40,476 BE PRODUCT DEVELOPMENT RELATED 1212 00:59:40,543 --> 00:59:43,379 TO THERAPEUTIC NEED AND CAMILLE 1213 00:59:43,446 --> 00:59:48,084 SPOKE THROUGH THE ACTIVITIES 1214 00:59:48,151 --> 00:59:49,719 ONGOING TO DEVELOP A PRIORITY 1215 00:59:49,786 --> 00:59:52,722 LIST AND WE HAVE NOTED WE WOULD 1216 00:59:52,789 --> 00:59:53,990 NOT DISCUSS RECOMMENDATION 8 1217 00:59:54,057 --> 00:59:57,961 BECAUSE THERE MAY BE NEED FOR 1218 00:59:58,027 --> 01:00:02,699 CONGRESSIONAL ACTIONS AND BASED 1219 01:00:02,765 --> 01:00:05,034 ON THE PROGRESS MADE IF THERE'S 1220 01:00:05,101 --> 01:00:06,135 ADDITIONAL DISCUSSION THE 1221 01:00:06,202 --> 01:00:07,437 COLLEAGUES WOULD LIKE TO HAVE 1222 01:00:07,503 --> 01:00:10,239 REGARDING 8B TODAY WE SHOULD GO 1223 01:00:10,306 --> 01:00:18,548 AHEAD AND ENTERTAIN THAT. 1224 01:00:18,614 --> 01:00:20,016 RECOMMENDATION NINE IS TO DRIVE 1225 01:00:20,083 --> 01:00:22,118 DISCOVERY AND DEVELOPMENT OF 1226 01:00:22,185 --> 01:00:24,554 THERAPEUTICS AND PRODUCTS FOR 1227 01:00:24,620 --> 01:00:26,222 CONDITIONS SPECIFIC TO PREGNANT 1228 01:00:26,289 --> 01:00:34,230 AND LACTATING WOMEN AND PART OF 1229 01:00:34,297 --> 01:00:36,666 ONE WAS IN THE REGARD TO THE 1230 01:00:36,733 --> 01:00:38,267 PRIORITIZATION PROJECT AND 1231 01:00:38,334 --> 01:00:40,269 SECOND WAS THE CONSIDERATION OF 1232 01:00:40,336 --> 01:00:45,041 NIH VACCINE MODEL. 1233 01:00:45,108 --> 01:00:51,914 SO WE HAVE PRE ADVISED WE WOULD 1234 01:00:51,981 --> 01:00:58,621 NOT DISCUSS 9B BECAUSE IT LIKELY 1235 01:00:58,688 --> 01:01:02,992 REQUIRES CONGRESSIONAL RESOURCES 1236 01:01:03,059 --> 01:01:04,594 AND 11 IS LEVERAGE ESTABLISHED 1237 01:01:04,660 --> 01:01:06,129 AND SUPPORT NEW INFRASTRUCTURES 1238 01:01:06,195 --> 01:01:09,465 AND COLLABORATIONS TO PERFORM 1239 01:01:09,532 --> 01:01:11,634 RESEARCH IN PREGNANT AND 1240 01:01:11,701 --> 01:01:14,504 LACTATING WOMEN AND WE THOUGHT 1241 01:01:14,570 --> 01:01:17,473 11A COULD BE ONE WE COULD NOT 1242 01:01:17,540 --> 01:01:19,742 DISCUSS TODAY BUT I THINK BASED 1243 01:01:19,809 --> 01:01:22,211 ON THE DISCUSSIONS WITH NAHIDA 1244 01:01:22,278 --> 01:01:28,851 AND AARON'S PRESENTATION WE 1245 01:01:28,918 --> 01:01:33,022 COULD LOOK AT MULTI-CENTER 1246 01:01:33,089 --> 01:01:34,223 INFRASTRUCTURES AND ONGOING 1247 01:01:34,290 --> 01:01:36,092 RESEARCH NETWORK AND TO 1248 01:01:36,159 --> 01:01:37,427 ENCOURAGE NETWORK AND 1249 01:01:37,493 --> 01:01:39,996 COLLABORATIONS TO ENGAGE IN 1250 01:01:40,063 --> 01:01:41,964 PUBLIC-PRIVATE PARTNERSHIPS. 1251 01:01:42,031 --> 01:01:47,537 WITH THAT QUICK OVERVIEW, I'D 1252 01:01:47,603 --> 01:01:58,147 LIKE TO OPEN THE DISCUSSION AND 1253 01:01:59,749 --> 01:02:02,685 SIMILAR TO HOW WE WORKED IN 1254 01:02:02,752 --> 01:02:03,820 NOVEMBER WE'LL GO AS FAR AS THE 1255 01:02:03,886 --> 01:02:04,987 TIME ALLOWS US TO GO. 1256 01:02:05,054 --> 01:02:06,923 WE HAD WONDERFUL PRESENTATIONS 1257 01:02:06,989 --> 01:02:09,959 TODAY FROM OUR NICHD COLLEAGUES. 1258 01:02:10,026 --> 01:02:11,327 SO IF WE'RE UNABLE TO GET 1259 01:02:11,394 --> 01:02:12,728 THROUGH ALL THE RECOMMENDATIONS 1260 01:02:12,795 --> 01:02:21,571 OFFLINE AS PREVIOUSLY MENTIONED 1261 01:02:21,637 --> 01:02:23,840 AND WORK WITH NIH STAFF AND PUT 1262 01:02:23,906 --> 01:02:26,843 TOGETHER A SUMMARY WITH OUR 1263 01:02:26,909 --> 01:02:28,711 PRODUCT ON WHERE WE THINK WE ARE 1264 01:02:28,778 --> 01:02:30,012 AND ASK ALL IN THE WORKING GROUP 1265 01:02:30,079 --> 01:02:40,623 TO WEIGH IN TO ADD OR TAKEAWAY. 1266 01:02:44,794 --> 01:02:47,663 WE'LL LOOK AT INCREASE THE 1267 01:02:47,730 --> 01:02:49,398 QUANTITY AND QUALITY AND 1268 01:02:49,465 --> 01:02:50,666 TIMELINESS OF RESEARCH ON SAFETY 1269 01:02:50,733 --> 01:02:52,768 AND EFFICACY OF THERAPEUTIC 1270 01:02:52,835 --> 01:02:54,237 PRODUCTS USED BY PREGNANT WOMEN 1271 01:02:54,303 --> 01:02:59,475 AND LACTATING WOMEN. 1272 01:02:59,542 --> 01:03:03,980 GOING BACK TO THE QUESTION FROM 1273 01:03:04,046 --> 01:03:06,616 THE FIRST PRESENTATION. 1274 01:03:06,682 --> 01:03:12,555 WITH A SYNTHESIS OF THE COMMENTS 1275 01:03:12,622 --> 01:03:14,891 THAT RELATE. 1276 01:03:14,957 --> 01:03:17,894 >> THERE WAS AN UNDERSTAND OF 1277 01:03:17,960 --> 01:03:19,395 THE ROAD BLOCKS DISCUSSED IF 1278 01:03:19,462 --> 01:03:22,198 THAT COULD BE ELABORATED ON AND 1279 01:03:22,265 --> 01:03:23,299 SPECIFIC TO LACTATION STUDIES. 1280 01:03:23,366 --> 01:03:26,235 IS THAT SOMETHING YOU'D LIKE TO 1281 01:03:26,302 --> 01:03:36,412 COVER? 1282 01:03:38,347 --> 01:03:39,916 >> THE INITIAL QUESTION IS WHO 1283 01:03:39,982 --> 01:03:43,519 WE FUND AND APPLICATIONS FOR 1284 01:03:43,586 --> 01:03:45,054 CLINICAL AND DATA COORDINATING 1285 01:03:45,121 --> 01:03:50,693 CENTERS OF OF THE APPLICATIONS 1286 01:03:50,760 --> 01:03:54,564 RECEIVED AND REVIEWED THEN WE 1287 01:03:54,630 --> 01:03:57,533 FUND X AMOUNT BASED ON 1288 01:03:57,600 --> 01:03:59,202 AVAILABILITY OF FUNDS AND I 1289 01:03:59,268 --> 01:04:01,504 QUESTION ABOUT RURAL POPULATIONS 1290 01:04:01,571 --> 01:04:03,639 WITHIN THE MATERNAL FETAL 1291 01:04:03,706 --> 01:04:04,907 MEDICINE UNIT NETWORK THE 1292 01:04:04,974 --> 01:04:10,146 APPLICANTS THAT CAME IN ARE THE 1293 01:04:10,213 --> 01:04:18,221 ONES THAT WERE REVIEWED FUNDED 1294 01:04:18,287 --> 01:04:21,023 AND THEY'RE PRIORITIZED WITHIN 1295 01:04:21,090 --> 01:04:21,891 WITHIN THE STEERING COMMITTEE OF 1296 01:04:21,958 --> 01:04:30,166 THE VARIOUS NETWORKS. 1297 01:04:30,233 --> 01:04:32,468 THERE'S ABILITY FOR OUTSIDE 1298 01:04:32,535 --> 01:04:33,402 RESEARCHERS IF INTERESTED THEY 1299 01:04:33,469 --> 01:04:34,070 CAN SUBMIT TO THE NETWORKS FOR 1300 01:04:34,136 --> 01:04:43,613 THOSE STUDIES. 1301 01:04:43,679 --> 01:04:51,921 WE DO CO-FUND NIAD THE IMPACT 1302 01:04:51,988 --> 01:04:54,223 NETWORK THEM AS A PRIMARY FUNDER 1303 01:04:54,290 --> 01:05:01,264 OF THE NETWORK AND NICHD 1304 01:05:01,330 --> 01:05:04,767 CO-FUNDS THAT NETWORK. 1305 01:05:04,834 --> 01:05:06,435 WE'VE BEEN DOING TRIALS AROUND 1306 01:05:06,502 --> 01:05:07,603 THERAPEUTICS OR LACTATION IN THE 1307 01:05:07,670 --> 01:05:09,839 NETWORK FOR A LONG TIME RELATED 1308 01:05:09,905 --> 01:05:13,743 TO HIV AND MEDICATIONS AROUND 1309 01:05:13,809 --> 01:05:18,214 USE OF MEDICATIONS IN PREGNANCY 1310 01:05:18,281 --> 01:05:21,517 AROUND HIV AND LACTATION AND 1311 01:05:21,584 --> 01:05:23,319 THERE WERE ALSO LEVERAGED FOR 1312 01:05:23,386 --> 01:05:26,188 THE COVID-19 LOOKING AT 1313 01:05:26,255 --> 01:05:30,860 MEDICATIONS FOR COVID AND NOW 1314 01:05:30,926 --> 01:05:34,230 HOPEFULLY FOR CRV DOWN THE LINE. 1315 01:05:34,297 --> 01:05:34,864 GO AHEAD. 1316 01:05:34,930 --> 01:05:44,173 >> THANK YOU, NAHIDA. 1317 01:05:44,240 --> 01:05:46,342 IT'S IMPORTANT TO UNDERSTAND THE 1318 01:05:46,409 --> 01:05:47,977 MAPPING AND WE KEEP REPEATING 1319 01:05:48,044 --> 01:05:53,282 PICKING SITES I'M NOT SEEING THE 1320 01:05:53,349 --> 01:06:01,991 SITES ACROSS NETWORKS 1321 01:06:02,058 --> 01:06:09,765 COLLABORATE AND ALL THESE SITES 1322 01:06:09,832 --> 01:06:11,967 ARE INSISTENCE FOR A DECADE PLUS 1323 01:06:12,034 --> 01:06:13,302 AND IT WOULD BE IMPORTANT TO 1324 01:06:13,369 --> 01:06:14,503 UNDERSTAND HOW THEY TALK TO EACH 1325 01:06:14,570 --> 01:06:15,871 OTHER BECAUSE THERE'S STRENGTH 1326 01:06:15,938 --> 01:06:18,341 IN WHAT THEY'RE DOING AND DO WE 1327 01:06:18,407 --> 01:06:20,876 NEED TO SEND OUT ANOTHER WHEN WE 1328 01:06:20,943 --> 01:06:25,848 HAVE SITES WITH EXPERTISE 1329 01:06:25,915 --> 01:06:31,153 THEY'RE DOING AND BY THE TIME 1330 01:06:31,220 --> 01:06:34,924 YOU GOT THE SITE UP AND RUNNING 1331 01:06:34,990 --> 01:06:38,094 AND KNOW RAVE AND REDCAP, 1332 01:06:38,160 --> 01:06:39,995 ETCETERA, THEY'RE REAPPLYING AND 1333 01:06:40,062 --> 01:06:50,539 ALL THE EFFORT GOES TO THAT. 1334 01:06:54,844 --> 01:06:57,012 WE ARE SILOING ALL THESE 1335 01:06:57,079 --> 01:06:58,981 NETWORKS OPPOSED TO PUTTING THEM 1336 01:06:59,048 --> 01:07:00,816 TO ONE UMBRELLA AND ENCOURAGING 1337 01:07:00,883 --> 01:07:02,351 SITES WHO PARTICIPATE IN ONE 1338 01:07:02,418 --> 01:07:03,986 NETWORK AND HERE'S A SCIENCE 1339 01:07:04,053 --> 01:07:04,387 IDEA. 1340 01:07:04,453 --> 01:07:06,222 WE'RE LOOKING FOR A SITE THAT 1341 01:07:06,288 --> 01:07:08,124 CAN DO X OR Y AND PULLING THEM 1342 01:07:08,190 --> 01:07:09,692 IN ACROSS THE NETWORKS OPPOSED 1343 01:07:09,759 --> 01:07:10,559 TO SILOING THEM WITHIN A 1344 01:07:10,626 --> 01:07:19,468 NETWORK. 1345 01:07:19,535 --> 01:07:21,604 >> THAT'S A GREAT POINT BUT 1346 01:07:21,670 --> 01:07:22,638 THERE'S VARIOUS EXPERTISE WITHIN 1347 01:07:22,705 --> 01:07:24,974 THE NETWORKS. 1348 01:07:25,040 --> 01:07:26,742 WHAT WE'RE INTERESTED IN IS 1349 01:07:26,809 --> 01:07:28,010 CROSS-NETWORK COLLABORATIONS AND 1350 01:07:28,077 --> 01:07:29,445 NOW WITH THE OPPORTUNITY TO OPEN 1351 01:07:29,512 --> 01:07:32,481 THE NETWORKS TO OUTSIDE 1352 01:07:32,548 --> 01:07:36,685 INVESTIGATORS THAT'S WHAT WE'RE 1353 01:07:36,752 --> 01:07:41,390 HOPING WOULD HAP JPEN YOU LOOK 1354 01:07:41,457 --> 01:07:43,859 THE SITE AND SEE IF THEY'RE ABLE 1355 01:07:43,926 --> 01:07:48,931 TO PARTICIPATE IN TRIALS. 1356 01:07:48,998 --> 01:07:56,338 FOR EXAMPLE, THERE'S PROPOSALS 1357 01:07:56,405 --> 01:08:00,543 THROUGH THE NEONATAL NETWORK AND 1358 01:08:00,609 --> 01:08:02,211 PROPOSALS LEVERAGING THE 1359 01:08:02,278 --> 01:08:12,721 PEDIATRICS TRIAL NETWORK. 1360 01:08:15,858 --> 01:08:16,559 BECAUSE WE HAVE DIFFERENT 1361 01:08:16,625 --> 01:08:21,864 EXPERTISE I DON'T THINK WE NEED 1362 01:08:21,931 --> 01:08:25,835 TO COMBINE THE RESEARCH SITES 1363 01:08:25,901 --> 01:08:29,238 AND SAY IF THERE'S AN X NUMBER 1364 01:08:29,305 --> 01:08:34,243 WE SHOULDN'T NECESSARILY FUND 1365 01:08:34,310 --> 01:08:36,045 THAT REGION OR INSTITUTION. 1366 01:08:36,111 --> 01:08:38,180 AND THE FIVE-YEAR CYCLE WAS 1367 01:08:38,247 --> 01:08:40,483 SHORT AND THE RECOMPETITION OF 1368 01:08:40,549 --> 01:08:42,084 THE NETWORK WENT TO SEVEN YEARS. 1369 01:08:42,151 --> 01:08:44,620 THEY WERE AWARDED IN 2023 AND 1370 01:08:44,687 --> 01:08:46,255 THEIR CYCLE IS SEVEN YEARS TO 1371 01:08:46,322 --> 01:08:56,165 2030. 1372 01:08:56,232 --> 01:09:01,237 >> IT SEEMS LIKE THERE'S A LOT 1373 01:09:01,303 --> 01:09:02,438 OF INTEREST IN THIS IN THE TIME 1374 01:09:02,505 --> 01:09:11,113 LINE FOR THE AWARD PERIOD AND 1375 01:09:11,180 --> 01:09:13,048 ARE THERE QUESTIONS ON WHAT THAT 1376 01:09:13,115 --> 01:09:14,550 COULD LOOK LIKE OR HAVE 1377 01:09:14,617 --> 01:09:16,585 DISCUSSION WHERE THE NEED MAY BE 1378 01:09:16,652 --> 01:09:17,553 IN MATERIALS OF THE SHORT CYCLE 1379 01:09:17,620 --> 01:09:27,196 PERIOD FOR THE AWARDS? 1380 01:09:27,263 --> 01:09:30,900 THAT'S A CHANGE FOR FMU BUT WHY 1381 01:09:30,966 --> 01:09:32,768 IT WOULD MATTER FOR OTHER 1382 01:09:32,835 --> 01:09:33,068 AUTHORITIES. 1383 01:09:33,135 --> 01:09:38,240 ALL THREE NETWORKS WITHIN THE 1384 01:09:38,307 --> 01:09:43,779 BRANCH FOR THE GLOBAL RESEARCH 1385 01:09:43,846 --> 01:09:46,415 NETWORK AND FMU ARE SEVEN-YEAR 1386 01:09:46,482 --> 01:09:47,349 CYCLES. 1387 01:09:47,416 --> 01:09:48,484 IN GENERAL WE'RE HOPING WE COULD 1388 01:09:48,551 --> 01:09:52,021 DO THE SAME FOR ALL NETWORKS BUT 1389 01:09:52,087 --> 01:09:54,023 FOR THE THREE THAT HAVE 1390 01:09:54,089 --> 01:09:59,328 RECOMPETED THIS YEAR, THAT'S THE 1391 01:09:59,395 --> 01:10:02,264 CYCLE INCREASED FROM SEVEN TO 1392 01:10:02,331 --> 01:10:07,202 FIVE YEARS. 1393 01:10:07,269 --> 01:10:10,339 >> ANY THOUGHTS ON THIS QUESTION 1394 01:10:10,406 --> 01:10:15,978 RELATED TO 2B. 1395 01:10:16,045 --> 01:10:17,613 >> IS THERE GOING TO BE A 1396 01:10:17,680 --> 01:10:21,183 CLEARING HOUSE FOR INVESTIGATORS 1397 01:10:21,250 --> 01:10:23,152 THAT SAYS HERE'S THE SCIENCE 1398 01:10:23,218 --> 01:10:24,920 QUESTION, ARE YOU A SITE IN 1399 01:10:24,987 --> 01:10:26,255 ANOTHER NETWORK YOU CAN APPLY TO 1400 01:10:26,322 --> 01:10:28,324 BE A SITE FOR THIS SCIENCE 1401 01:10:28,390 --> 01:10:31,594 QUESTION OR IS THERE A CLEARING 1402 01:10:31,660 --> 01:10:33,629 HOUSE THAT SAYS WE'RE LOOKING 1403 01:10:33,696 --> 01:10:36,332 FOR CLINICAL TRIALS ON X OR Y 1404 01:10:36,398 --> 01:10:38,267 AND HERE HOW IT'S SUBMITTED. 1405 01:10:38,334 --> 01:10:39,635 BECAUSE OF THE SILOING, MOST 1406 01:10:39,702 --> 01:10:40,936 PEOPLE DON'T KNOW HOW TO ACROSS 1407 01:10:41,003 --> 01:10:42,938 INTO THE OTHER NETWORKS. 1408 01:10:43,005 --> 01:10:45,140 >> GREAT POINT, SHARON. 1409 01:10:45,207 --> 01:10:46,942 SO AS YOU KNOW, THE 1410 01:10:47,009 --> 01:10:49,378 INVESTIGATORS ARE THE ONES THAT 1411 01:10:49,445 --> 01:10:50,379 PROPOSE TRIALS TO NICHD. 1412 01:10:50,446 --> 01:10:53,048 DOES NOT GO OUT AND SAY WE WANT 1413 01:10:53,115 --> 01:10:55,517 A TRIAL IN X, Y, Z. 1414 01:10:55,584 --> 01:10:57,686 IT'S THE PRIORITIES OF THE 1415 01:10:57,753 --> 01:10:59,855 VARIOUS NETWORKS AND THE P.I.s 1416 01:10:59,922 --> 01:11:01,223 HAVE BEEN DOING OUTREACH BUT 1417 01:11:01,290 --> 01:11:06,962 WE'VE BEEN THINKING ABOUT IF 1418 01:11:07,029 --> 01:11:08,497 THERE'S A PARTICULAR STUDY AND 1419 01:11:08,564 --> 01:11:10,232 WE NEED ADDITIONAL RECRUITMENT 1420 01:11:10,299 --> 01:11:17,640 SITES HOW THAT WOULD WORK. 1421 01:11:17,706 --> 01:11:18,507 IT'S A GREAT POINT AND SOMETHING 1422 01:11:18,574 --> 01:11:20,409 TO CONSIDER FOR US. 1423 01:11:20,476 --> 01:11:21,210 >> THANK YOU. 1424 01:11:21,276 --> 01:11:22,745 DID SEE THERE'S ANOTHER QUESTION 1425 01:11:22,811 --> 01:11:25,014 COMING UP FROM TINA BUT I WANT 1426 01:11:25,080 --> 01:11:26,348 TO ADDRESS A QUESTION THAT'S 1427 01:11:26,415 --> 01:11:28,150 COME UP A COUPLE TIMES IN 1428 01:11:28,217 --> 01:11:30,252 REGARDS TO THE PRE-CLINICAL 1429 01:11:30,319 --> 01:11:33,756 STUDIES. 1430 01:11:33,822 --> 01:11:44,133 I DON'T KNOW IF DR. ELESE WANTED 1431 01:11:44,199 --> 01:11:47,269 TO COME BACK AND TALK ABOUT THE 1432 01:11:47,336 --> 01:11:47,803 TRANSITIONAL SPACE. 1433 01:11:47,870 --> 01:11:58,147 >> THIS IS TONY. 1434 01:11:59,782 --> 01:12:01,283 IN LOOK AT THE NEED FOR THE 1435 01:12:01,350 --> 01:12:04,386 PREOR MODIFIED STUDY I SAW A FEW 1436 01:12:04,453 --> 01:12:09,558 LISTED IN THE SLIDE BUT I'M 1437 01:12:09,625 --> 01:12:12,461 STRUGGLING TO UNDERSTAND HOW 1438 01:12:12,528 --> 01:12:17,032 THOSE MAY BE USED WITHIN 1439 01:12:17,099 --> 01:12:19,068 INDUSTRY EARLIER BECAUSE I THINK 1440 01:12:19,134 --> 01:12:23,338 THE PHARMA INDUSTRY IS IN A 1441 01:12:23,405 --> 01:12:25,541 PERFECT PLACE TO DEVELOP DATA 1442 01:12:25,607 --> 01:12:28,877 THAT MAYBE ABLE TO HELP WITHIN 1443 01:12:28,944 --> 01:12:31,080 CLINICAL TRIALS OR HELP 1444 01:12:31,146 --> 01:12:31,814 MARKETING CLINICAL TRIALS, 1445 01:12:31,880 --> 01:12:32,948 THINGS OF THAT NATURE. 1446 01:12:33,015 --> 01:12:34,983 IT WOULD BE NICE TO SEE A 1447 01:12:35,050 --> 01:12:37,786 NETWORK THAT MIGHT BE FORMED. 1448 01:12:37,853 --> 01:12:42,391 I KNOW IN THE PRGLAC 1449 01:12:42,458 --> 01:12:43,459 IMPLEMENTATION GUIDE IT TALKS 1450 01:12:43,525 --> 01:12:50,032 ABOUT THE FIRST STEP BEING A 1451 01:12:50,099 --> 01:12:51,800 WORKING GROUP SO IF THAT'S A 1452 01:12:51,867 --> 01:12:57,106 POSSIBILITY OR IT MAYBE HELPFUL 1453 01:12:57,172 --> 01:13:01,210 IF IF IT'S MADE KNOWN MORE 1454 01:13:01,276 --> 01:13:06,415 WIDELY SO PEOPLE CAN 1455 01:13:06,482 --> 01:13:16,692 PARTICIPATE. 1456 01:13:22,765 --> 01:13:25,534 >> ONE IS A PUSH TO HAVE MODELS 1457 01:13:25,601 --> 01:13:28,904 MORE PREDICTIVE OR COMPLEMENT 1458 01:13:28,971 --> 01:13:31,306 WHAT'S TYPICALLY DONE IN ANIMAL 1459 01:13:31,373 --> 01:13:33,108 MODELS AND IN AN AREA WHERE 1460 01:13:33,175 --> 01:13:35,577 ANIMAL MODELS ARE NOT AS 1461 01:13:35,644 --> 01:13:35,878 REFLECTIVE. 1462 01:13:35,944 --> 01:13:40,883 THE COMPLIMENTARY PROGRAM IS 1463 01:13:40,949 --> 01:13:51,493 ALSO BUILT ON A GROUP AND WE'VE 1464 01:13:56,331 --> 01:14:00,035 HAD A PRIMARY REPRESENTATIVE. 1465 01:14:00,102 --> 01:14:02,838 THERE'S AN A LOT OF INPUT FROM 1466 01:14:02,905 --> 01:14:03,772 THE FDA AND REGULATORS 1467 01:14:03,839 --> 01:14:04,773 RECOGNIZING THE NEED FOR THESE 1468 01:14:04,840 --> 01:14:06,909 BETTER MODELS. 1469 01:14:06,975 --> 01:14:11,013 THAT WILL INCLUDE USING DATA. 1470 01:14:11,079 --> 01:14:13,215 THE COMPLEMENTARY PROGRAM IS 1471 01:14:13,282 --> 01:14:15,384 VERY MUCH LOOKING AT IN SILLICA 1472 01:14:15,450 --> 01:14:21,623 MODELS AND WHAT WE CAN DO WITH 1473 01:14:21,690 --> 01:14:28,630 MORE DATA AND LOOKING AT OTHER 1474 01:14:28,697 --> 01:14:29,965 CONSTRUCTS AND NOVEL AND 1475 01:14:30,032 --> 01:14:30,632 CHEMICAL APPROACHES THAT COULD 1476 01:14:30,699 --> 01:14:34,002 BE USED FOR PREDICTIVE 1477 01:14:34,069 --> 01:14:35,070 CAPABILITY. 1478 01:14:35,137 --> 01:14:36,205 SOME ACTIVITIES THE 1479 01:14:36,271 --> 01:14:37,773 COMPLIMENTARY WORKING GROUP HAS 1480 01:14:37,840 --> 01:14:39,575 UNDERTAKEN AS IT'S BEEN SCOPING 1481 01:14:39,641 --> 01:14:42,511 OUT WHAT IT CAN POTENTIALLY DO 1482 01:14:42,578 --> 01:14:44,980 IS HAVING A LARGE WORKING GROUP 1483 01:14:45,047 --> 01:14:47,716 AND ENGAGEMENT WITH THE 1484 01:14:47,783 --> 01:14:49,518 FOUNDATION FOR THE NIH AND 1485 01:14:49,585 --> 01:14:51,587 RUDOLPH FOUNDATION AND MILKEN 1486 01:14:51,653 --> 01:14:55,657 INSTITUTE. 1487 01:14:55,724 --> 01:15:05,500 THE GOAL IS FOR TO AND ENHANCING 1488 01:15:05,567 --> 01:15:08,971 THE STUDIES IS VERY MUCH ON 1489 01:15:09,037 --> 01:15:10,539 FOLKS' MINDS. 1490 01:15:10,606 --> 01:15:21,149 WE'RE HOPING IT CAN BE SOMETHING 1491 01:15:24,753 --> 01:15:26,455 AND WOULD BE GREAT TO MOVE FROM 1492 01:15:26,521 --> 01:15:29,558 DRUG DEVELOPMENT INTO THE DRUG 1493 01:15:29,625 --> 01:15:31,260 DISCOVERY PHASE AND CLINICAL 1494 01:15:31,326 --> 01:15:33,595 SCAFFOLDS AND THERAPEUTICS CAN 1495 01:15:33,662 --> 01:15:35,130 HAVE PROPERTIES THAT MAY BE 1496 01:15:35,197 --> 01:15:36,632 LIABILITIES DOWN THE ROAD IN 1497 01:15:36,698 --> 01:15:45,741 TERMS OF ELIMINATING MORE AND 1498 01:15:45,807 --> 01:15:47,409 EARLIER IN THE PROCESS AND I 1499 01:15:47,476 --> 01:15:48,844 THINK WE'RE IN A GOOD DIRECTION 1500 01:15:48,911 --> 01:15:50,545 WITH COMPLIMENTARY. 1501 01:15:50,612 --> 01:15:52,014 >> THANK YOU, AARON. 1502 01:15:52,080 --> 01:15:54,149 IT LOOKS LIKE THAT RESOLVED 1503 01:15:54,216 --> 01:15:55,484 BECKY'S QUESTION AS WELL SO 1504 01:15:55,550 --> 01:15:56,184 THANK YOU. 1505 01:15:56,251 --> 01:16:02,457 TINA, I THINK I SAW YOUR LAND 1506 01:16:02,524 --> 01:16:12,634 NEXT. 1507 01:16:17,472 --> 01:16:19,508 >> IF THERE WOULD BE AN OVERLAY 1508 01:16:19,574 --> 01:16:21,243 WHERE OTHER NETWORKS EXIST AND 1509 01:16:21,310 --> 01:16:31,720 INCENTIVIZATION FOR AND 1510 01:16:37,693 --> 01:16:38,460 ACCELERATE RESEARCH INITIATIVES 1511 01:16:38,527 --> 01:16:39,461 WHERE THERE'S EXISTING 1512 01:16:39,528 --> 01:16:40,629 INFRASTRUCTURE AND COULD WORK 1513 01:16:40,696 --> 01:16:43,999 ACROSS THE PREGNANCY AND 1514 01:16:44,066 --> 01:16:47,803 LACTATION SPACE SATION NEONATAL 1515 01:16:47,869 --> 01:16:54,710 -- SAYING NEONATAL NETWORK AND 1516 01:16:54,776 --> 01:16:54,943 FMU. 1517 01:16:55,010 --> 01:16:57,612 >> THERE'S CROSS-REFERENCE AND 1518 01:16:57,679 --> 01:16:58,313 WE'LL COME BACK TO IT. 1519 01:16:58,380 --> 01:17:08,623 ANY RESPONSE? 1520 01:17:16,498 --> 01:17:21,003 >> AND THIS IS DIRECTED TO 1521 01:17:21,069 --> 01:17:22,437 NAHIDA, I'VE BEEN LISTENING TO 1522 01:17:22,504 --> 01:17:24,106 THE WONDERFUL WORK OF THE 1523 01:17:24,172 --> 01:17:27,409 NETWORK AND AT THE VERY END OF 1524 01:17:27,476 --> 01:17:30,379 YOUR LAST COMMENT I SAW THE NEED 1525 01:17:30,445 --> 01:17:33,348 OF WHAT I'VE BEEN WANTING TO 1526 01:17:33,415 --> 01:17:34,850 HEAR THAT IS THAT THE 1527 01:17:34,916 --> 01:17:38,954 INVESTIGATORS INITIATE THE 1528 01:17:39,021 --> 01:17:39,588 PROPOSALS. 1529 01:17:39,654 --> 01:17:43,825 IS THERE EVER A POSSIBILITY 1530 01:17:43,892 --> 01:17:44,926 WHERE THERE ARE PRIORITIES 1531 01:17:44,993 --> 01:17:46,528 ESTABLISHED FOR PROPOSALS SO 1532 01:17:46,595 --> 01:17:49,131 THEY MAY POSSIBLY ALIGN WITH THE 1533 01:17:49,197 --> 01:17:53,902 PREG LACK BEING MORE DIRECTIVE 1534 01:17:53,969 --> 01:17:59,274 SO THAT RESEARCH IS -- DOES THAT 1535 01:17:59,341 --> 01:18:03,779 MAKE SENSE? 1536 01:18:03,845 --> 01:18:05,347 >> MAKES SPENCE IT'S A BALANCE 1537 01:18:05,414 --> 01:18:06,248 BETWEEN WHAT THE EXERTS IN THE 1538 01:18:06,314 --> 01:18:11,253 AREA THINK IS A PRIORITY FOR 1539 01:18:11,319 --> 01:18:16,158 RESEARCH VERSUS WHAT WE TELL 1540 01:18:16,224 --> 01:18:18,093 INVESTIGATORS TO DO AND WHEN WE 1541 01:18:18,160 --> 01:18:19,361 HAD ADDITIONAL DOLLARS LIKE 1542 01:18:19,428 --> 01:18:20,762 DURING COVID WE SAID YOU'RE IN 1543 01:18:20,829 --> 01:18:22,130 THE FIELD WHAT CAN YOU DO AND 1544 01:18:22,197 --> 01:18:24,166 THEY CAME UP WITH A PROPOSAL OF 1545 01:18:24,232 --> 01:18:29,337 WHAT WOULD BE DONE. 1546 01:18:29,404 --> 01:18:32,941 FOR EXAMPLE, THE RECOVER 1547 01:18:33,008 --> 01:18:36,812 ACTIVITIES AND SIMILAR FOR THE 1548 01:18:36,878 --> 01:18:38,747 IMPACT NETWORK CHILDREN 1549 01:18:38,814 --> 01:18:39,014 MENTIONED. 1550 01:18:39,081 --> 01:18:42,851 THERE'D OPPORTUNITIES IF THERE'S 1551 01:18:42,918 --> 01:18:44,886 A SPECIFIC NEED TO SAY WE HAVE 1552 01:18:44,953 --> 01:18:46,088 ADDITIONAL FUNDS AND WHAT CAN 1553 01:18:46,154 --> 01:18:47,222 YOU DO WITH THESE. 1554 01:18:47,289 --> 01:18:52,828 SAME FOR THE HEAL ACTIVITIES 1555 01:18:52,894 --> 01:19:01,803 THERE WAS A PROTOCOL TO LOOK AT 1556 01:19:01,870 --> 01:19:04,339 REDUCING OPIOID USE IN 1557 01:19:04,406 --> 01:19:06,174 POST-CAESAREAN DELIVERIES. 1558 01:19:06,241 --> 01:19:07,709 THERE'S OPPORTUNITIES BUT THE 1559 01:19:07,776 --> 01:19:11,813 MAIN ACTIVITIES AND THE 1560 01:19:11,880 --> 01:19:14,282 PRIORITIES OF THE NETWORK ARE 1561 01:19:14,349 --> 01:19:15,650 LED BY THE VARIOUS NETWORKS AND 1562 01:19:15,717 --> 01:19:17,285 WHY THEY WERE SELECTED. 1563 01:19:17,352 --> 01:19:24,826 >> THANK YOU. 1564 01:19:24,893 --> 01:19:27,429 >> I'M GOING TO SUGGEST WE MOVE 1565 01:19:27,496 --> 01:19:29,798 TO RECOMMENDATION 8 BUT IF YOU 1566 01:19:29,865 --> 01:19:31,032 CONTINUE TO HAVE THOUGHTS IN 1567 01:19:31,099 --> 01:19:32,534 REGARDS TO RECOMMENDATION 2 NOTE 1568 01:19:32,601 --> 01:19:34,903 IT IN THE CHAT THAT IT'S 1569 01:19:34,970 --> 01:19:36,738 SPECIFIC TO RECOMMENDATION 2 SO 1570 01:19:36,805 --> 01:19:40,542 WHEN WE REVIEW THE COMMENTS WE 1571 01:19:40,609 --> 01:19:42,577 UNDERSTAND WHAT IT WAS LINKED TO 1572 01:19:42,644 --> 01:19:46,248 TO ENSURE WE ADEQUATELY COVERED 1573 01:19:46,314 --> 01:19:47,282 THE PROGRESS TO DATE. 1574 01:19:47,349 --> 01:19:48,583 RECOMMENDATION 8 AS YOU RECALL 1575 01:19:48,650 --> 01:19:52,988 WE HAD ADVISED WE WOULD NOT BE 1576 01:19:53,054 --> 01:19:54,689 DISCUSSING TODAY BUT IT'S CLEAR 1577 01:19:54,756 --> 01:19:57,692 FROM WHAT WAS OUTLINED THAT 1578 01:19:57,759 --> 01:19:59,027 NICHD IS ALREADY MADE PROGRESS 1579 01:19:59,094 --> 01:20:00,095 ON PRIORITIZATION AND THERE WILL 1580 01:20:00,162 --> 01:20:10,472 BE MORE TO FOLLOW. 1581 01:20:16,011 --> 01:20:21,383 WHILE THERE'S RECOMMENDATIONS 1582 01:20:21,449 --> 01:20:22,484 NICHD DEVELOPED PROCESSES FOR 1583 01:20:22,551 --> 01:20:33,061 PREGNANT AND LACTATING WOMEN. 1584 01:20:59,387 --> 01:21:01,623 WANT TO DISCUSS 9A TO THE 1585 01:21:01,690 --> 01:21:02,324 RECOMMENDATION. 1586 01:21:02,390 --> 01:21:04,359 IN TERMS OF PROGRAMS TO DRIVE 1587 01:21:04,426 --> 01:21:06,761 DISCOVERY AND DEVELOPMENT OF 1588 01:21:06,828 --> 01:21:07,996 THERAPEUTICS, I WANT TO MAKE 1589 01:21:08,063 --> 01:21:09,497 SURE WE'RE LISTENING TO YOUR 1590 01:21:09,564 --> 01:21:10,932 THOUGHTS AND DISCUSSION IN TERMS 1591 01:21:10,999 --> 01:21:12,500 OF WHERE WE ARE IN TERMS OF 1592 01:21:12,567 --> 01:21:22,978 PROGRESS TO DATE FOR 9A. 1593 01:21:28,049 --> 01:21:30,252 >> THIS IS ALLENI. 1594 01:21:30,318 --> 01:21:32,621 I HAVE ONE QUESTION AND ONE SIDE 1595 01:21:32,687 --> 01:21:36,224 NOTE YOU REFERENCED ME AS 1596 01:21:36,291 --> 01:21:41,596 DR. TSIGAS I APPRECIATE THE 1597 01:21:41,663 --> 01:21:42,831 PROMOTION BUT I'LL SOUND MORE 1598 01:21:42,897 --> 01:21:43,832 IGNORANT THAN I SHOULD. 1599 01:21:43,898 --> 01:21:45,600 I'M NOT A DOCTOR. 1600 01:21:45,667 --> 01:21:46,268 I'M A CONSUMER REPRESENTATIVE TO 1601 01:21:46,334 --> 01:21:55,110 THE GROUP. 1602 01:21:55,176 --> 01:21:58,079 I DON'T HAVE A PROBLEM THAT 1603 01:21:58,146 --> 01:21:58,913 THERE HASN'T BEEN SUFFICIENT 1604 01:21:58,980 --> 01:21:59,114 WORK. 1605 01:21:59,180 --> 01:22:01,016 I WOULD BE INTERESTED AND THIS 1606 01:22:01,082 --> 01:22:02,817 IS PROBABLY AN OFFLINE 1607 01:22:02,884 --> 01:22:04,986 CONVERSATION IN UNDERSTANDING 1608 01:22:05,053 --> 01:22:09,391 WHAT THE GROUP CONSIDERS NEEDED 1609 01:22:09,457 --> 01:22:14,796 CONGRESSIONAL ACTION SO THOSE OF 1610 01:22:14,863 --> 01:22:18,500 US INVOLVED IN ADVOCACY COULD 1611 01:22:18,566 --> 01:22:23,738 ALIGN AS A SEPARATE ACTIVITY. 1612 01:22:23,805 --> 01:22:27,008 THAT'S MY COMMENT. 1613 01:22:27,075 --> 01:22:29,744 >> IT'S OUR FEELING THERE MAY BE 1614 01:22:29,811 --> 01:22:30,945 ADDITIONAL RESOURCES NECESSARY 1615 01:22:31,012 --> 01:22:33,214 TO PUT ACTIVITIES SUCH AS THE 1616 01:22:33,281 --> 01:22:38,586 BARDA LIKE MODEL IN PLACE. 1617 01:22:38,653 --> 01:22:40,722 GIVEN THAT WE DO BELIEVE THERE'S 1618 01:22:40,789 --> 01:22:44,492 NEED FOR THERE TO BE ADDITIONAL 1619 01:22:44,559 --> 01:22:45,593 CONSIDERATION CONGRESSIONALLY 1620 01:22:45,660 --> 01:22:50,231 AROUND WHAT THAT WOULD BE LIKE 1621 01:22:50,298 --> 01:22:53,868 TO ADEQUATELY SUPPORT AND SOME 1622 01:22:53,935 --> 01:23:04,346 COULD NEED THAT SUPPORT. 1623 01:23:06,147 --> 01:23:08,316 THESE ARE THINGS ANTICIPATED OR 1624 01:23:08,383 --> 01:23:09,551 EXPECTED THERE MAY BE MORE WORK 1625 01:23:09,617 --> 01:23:12,620 THAT NEEDS TO BE DONE OUTSIDE 1626 01:23:12,687 --> 01:23:13,722 THE ORIGINAL RECOMMENDATIONS 1627 01:23:13,788 --> 01:23:14,155 MADE. 1628 01:23:14,222 --> 01:23:16,291 WE UNDERSTAND IT'S AN EVOLUTION 1629 01:23:16,358 --> 01:23:20,028 AND IT'S IMPORTANT TO GUIDE THE 1630 01:23:20,095 --> 01:23:21,363 HANDS TO PUT ADDITIONAL POLICY 1631 01:23:21,429 --> 01:23:22,497 IN PLACE TO SUPPORT THE 1632 01:23:22,564 --> 01:23:29,003 RECOMMENDATIONS. 1633 01:23:29,070 --> 01:23:30,338 DOES THAT ANSWER THE QUESTION? 1634 01:23:30,405 --> 01:23:32,574 WE'RE NOT GOING TO IGNORE IT IN 1635 01:23:32,640 --> 01:23:34,242 THE REPORT BUT THERE'S MORE THAT 1636 01:23:34,309 --> 01:23:44,619 NEEDS TO BE DONE. 1637 01:23:44,953 --> 01:23:46,888 ANY COMMENTS IN REGARDS TO 58B 1638 01:23:46,955 --> 01:23:52,927 OR 9A AND THEN WE'LL MOVE ON TO 1639 01:23:52,994 --> 01:24:02,537 RECOMMENDATION 11. 1640 01:24:02,604 --> 01:24:10,044 SO RECOMMENDATION 11 IS QUITE 1641 01:24:10,111 --> 01:24:11,980 EXTENSIVE TO LEVERAGE 1642 01:24:12,046 --> 01:24:14,883 ESTABLISHED AND SUPPORT NEW 1643 01:24:14,949 --> 01:24:15,517 INFRASTRUCTURES/COLLABORATIONS 1644 01:24:15,583 --> 01:24:16,751 TO PERFORM RESEARCH IN PREGNANT 1645 01:24:16,818 --> 01:24:17,318 AND LACTATING WOMEN. 1646 01:24:17,385 --> 01:24:20,688 WHEN I GAVE THE OVERVIEW I THINK 1647 01:24:20,755 --> 01:24:27,462 WE SHOULD DISCUSS 11A, 11B AND 1648 01:24:27,529 --> 01:24:28,730 11C BECAUSE IT'S CLEAR THERE'S 1649 01:24:28,797 --> 01:24:30,899 WORK IN THESE SPACES. 1650 01:24:30,965 --> 01:24:33,268 I'M HAPPY TO OPEN BACK UP IN 1651 01:24:33,334 --> 01:24:33,802 REGARDS TO THE RESEARCH 1652 01:24:33,868 --> 01:24:44,345 INFRASTRUCTURE AND NETWORKS. 1653 01:24:51,219 --> 01:24:54,522 >> OF WHAT AARON TALKED ABOUT I 1654 01:24:54,589 --> 01:24:57,992 THINK ADDRESSES THAT IN TERMS 1655 01:24:58,059 --> 01:25:04,265 OF -- I'M FAMILIAR WITH THAT IN 1656 01:25:04,332 --> 01:25:06,267 TERMS OF PROVIDING ADDITIONAL 1657 01:25:06,334 --> 01:25:06,768 RESOURCES WHERE AN 1658 01:25:06,835 --> 01:25:11,206 INFRASTRUCTURE ALREADY EXISTS TO 1659 01:25:11,272 --> 01:25:13,541 EXPAND AND ENHANCE THAT AND 1660 01:25:13,608 --> 01:25:15,243 THAT'S A TREMENDOUS MOVE IN THE 1661 01:25:15,310 --> 01:25:15,643 RIGHT DIRECTION. 1662 01:25:15,710 --> 01:25:23,384 WOULD LIKE TO SEE MORE OF THAT. 1663 01:25:23,451 --> 01:25:25,119 THANK YOU, TINA. 1664 01:25:25,186 --> 01:25:28,223 >> I WAS THINKING OF METRICS AND 1665 01:25:28,289 --> 01:25:30,124 HOW THAT WILL BE USED TO BRING 1666 01:25:30,191 --> 01:25:30,625 IN NEW SITES. 1667 01:25:30,692 --> 01:25:33,495 IT'S NICE THE NETWORK HAS A 1668 01:25:33,561 --> 01:25:35,563 STUDY THEY THINK IS A HIGH 1669 01:25:35,630 --> 01:25:36,698 IMPORTANT PRIORITY BUT IT TAKES 1670 01:25:36,764 --> 01:25:42,036 FOUR AREAS TO ENROLL. 1671 01:25:42,103 --> 01:25:44,539 OFTEN TIMES BY THE TIME YOU GET 1672 01:25:44,606 --> 01:25:45,540 THE DATA ARE WE IN THE RIGHT 1673 01:25:45,607 --> 01:25:47,275 PLACE AND WE LOOK AT THE METRICS 1674 01:25:47,342 --> 01:25:52,080 FOR THE SITES, WHO IS DOING WHAT 1675 01:25:52,146 --> 01:25:53,748 AND SHOULD WE GET MORE SITES AND 1676 01:25:53,815 --> 01:25:56,551 ONE THING I'D LIKE TO SEE ACROSS 1677 01:25:56,618 --> 01:25:59,487 THESE NETWORKS AND SITES IS 1678 01:25:59,554 --> 01:26:02,257 COMMONALITY OF LANGUAGE ON 1679 01:26:02,323 --> 01:26:04,926 METRICS OR SITES SO WE CAN SAY 1680 01:26:04,993 --> 01:26:07,529 YOU HAVE A STUDY YOU HAVE AN 1681 01:26:07,595 --> 01:26:08,563 ADDITIONAL THREE SITES AND LET'S 1682 01:26:08,630 --> 01:26:10,565 FIND THE THREE SITES AND HERE'S 1683 01:26:10,632 --> 01:26:15,937 THE SITES WE COULD APPLY FOR 1684 01:26:16,004 --> 01:26:19,440 THIS AND HERE'S THE METRICS AND 1685 01:26:19,507 --> 01:26:20,942 TIMELINESS AND BRING THE IN. 1686 01:26:21,009 --> 01:26:22,810 TIME IS MONEY AND YOU GET THE 1687 01:26:22,877 --> 01:26:33,388 ANSWER QUICKER AND MEANS MORE. 1688 01:26:34,155 --> 01:26:35,857 WE CAB UNDERSTAND AS NETWORK 1689 01:26:35,924 --> 01:26:38,726 LEADERS OR INVESTIGATORS WHO TO 1690 01:26:38,793 --> 01:26:40,728 PICK, WHAT TO PICK TO GET THE 1691 01:26:40,795 --> 01:26:41,763 STUDIES DONE SOONER. 1692 01:26:41,829 --> 01:26:48,436 AS BE AN ASIDE, THAT IS VERY 1693 01:26:48,503 --> 01:26:52,206 IMPORTANT TO SOME OF OUR PHARMA 1694 01:26:52,273 --> 01:26:55,009 PARTNERS WE CAN SAY HERE'S THE 1695 01:26:55,076 --> 01:26:55,944 METRICS AND WE CAN PICK THE 1696 01:26:56,010 --> 01:27:01,950 SITES WE CAN GET YOUR ANSWER AND 1697 01:27:02,016 --> 01:27:05,219 HERE'S THE ONES THAT GO RESEARCH 1698 01:27:05,286 --> 01:27:06,387 AND THAT WOULD MAKE SENSE AND 1699 01:27:06,454 --> 01:27:07,021 BOOST ALL THE NETWORKS. 1700 01:27:07,088 --> 01:27:17,365 I'LL STOP THERE. 1701 01:27:25,940 --> 01:27:28,543 >> I THINK IT'S SOMETHING TO 1702 01:27:28,610 --> 01:27:28,843 CONSIDER. 1703 01:27:28,910 --> 01:27:30,345 TO GO BACK SINCE I KNEW MORE 1704 01:27:30,411 --> 01:27:33,915 ABOUT THE IMPACT NETWORK AND 1705 01:27:33,982 --> 01:27:37,151 LIKE THE IDEA OF POTENTIALLY 1706 01:27:37,218 --> 01:27:38,286 HAVING MULTIPLE SITES. 1707 01:27:38,353 --> 01:27:45,393 THE IMPACT NETWORK IS YOU HAVE 1708 01:27:45,460 --> 01:27:47,462 26, 30 SITES GLOBALLY YOU CAN 1709 01:27:47,528 --> 01:27:56,337 ENROLL IN A PARTICULAR STUDY AND 1710 01:27:56,404 --> 01:27:58,239 LOOK AT THE PROTOCOL TO ENROLL 1711 01:27:58,306 --> 01:28:01,209 IN THE STUDY. 1712 01:28:01,275 --> 01:28:04,479 THE DIFFERENCE IS THIS IS FOR 1713 01:28:04,545 --> 01:28:07,215 THE 14 SITES HAVE HAD TO MET THE 1714 01:28:07,281 --> 01:28:08,282 MINIMAL REQUIREMENT FOR THEM TO 1715 01:28:08,349 --> 01:28:08,950 BE A SITE. 1716 01:28:09,017 --> 01:28:14,288 MEANING THEY HAVE TO HAVE THE 1717 01:28:14,355 --> 01:28:21,729 NUMBER HIGH RISK WOMEN AND HAVE 1718 01:28:21,796 --> 01:28:23,398 TO HAVE X AMOUNT OF DELIVERIES 1719 01:28:23,464 --> 01:28:26,234 AT THEIR SITES AND THE NUMBER OF 1720 01:28:26,300 --> 01:28:33,941 SITES THAT IS INVOLVED. 1721 01:28:34,008 --> 01:28:38,546 THE EXPECT FOR THE NETWORK ANY 1722 01:28:38,613 --> 01:28:42,250 PROTOCOL FROM THE NETWORK IS 1723 01:28:42,316 --> 01:28:44,085 APPROVED BY THE STEERING 1724 01:28:44,152 --> 01:28:45,687 COMMITTEE AND NIH WOULD BE 1725 01:28:45,753 --> 01:28:47,188 RECRUITING FROM ALL THE SITES 1726 01:28:47,255 --> 01:28:49,357 PART OF THE NETWORK. 1727 01:28:49,424 --> 01:28:55,630 I THINK THE RESTRUCTURING TO SAY 1728 01:28:55,697 --> 01:29:00,935 TO KEEP THAT AND IS A THERE'S 1729 01:29:01,002 --> 01:29:03,571 OTHER NICHD NETWORKS THAT COULD 1730 01:29:03,638 --> 01:29:07,675 BE LEVERAGED IF THERE'S A 1731 01:29:07,742 --> 01:29:09,277 PROTOCOL THAT REQUIRES 10,000 1732 01:29:09,343 --> 01:29:12,480 WOMEN OPPOSED TO 4,000 WOMEN. 1733 01:29:12,547 --> 01:29:14,248 THAT ALSO TAKES INTO CROSS THERE 1734 01:29:14,315 --> 01:29:16,150 MAY BE NEEDED ADDITIONAL FUNDS 1735 01:29:16,217 --> 01:29:18,152 TO BRING ON SITES NOT PART OF 1736 01:29:18,219 --> 01:29:22,256 THE EXISTING NETWORK THAT WE 1737 01:29:22,323 --> 01:29:28,963 PROVIDE INFRASTRUCTURE FOR. 1738 01:29:29,030 --> 01:29:34,268 LOOKING AT THE DIFFERENT 1739 01:29:34,335 --> 01:29:36,170 STRUCTURE WITHIN NICHD AND THEN 1740 01:29:36,237 --> 01:29:39,040 WE POTENTIALLY CO-FUND AND SEE 1741 01:29:39,107 --> 01:29:42,243 HOW WE CAN HAVE READY SITES THAT 1742 01:29:42,310 --> 01:29:42,777 COULD PARTICIPATE. 1743 01:29:42,844 --> 01:29:45,947 AS AN EXAMPLE THIS WAS DONE FOR 1744 01:29:46,013 --> 01:29:49,717 THE CMV BETWEEN THE FMU AND 1745 01:29:49,784 --> 01:29:52,854 IMPACT BECAUSE THE CMV TRIAL WAS 1746 01:29:52,920 --> 01:29:56,591 NOT ENROLLING AND WE ADDED SITES 1747 01:29:56,657 --> 01:29:59,927 TO PARTICIPATE IN THE STUDY. 1748 01:29:59,994 --> 01:30:05,233 THERE IS PRECEDENT TO HOW THIS 1749 01:30:05,299 --> 01:30:14,942 WAS DONE BUT I THINK MAYBE 1750 01:30:15,009 --> 01:30:15,576 HAVING A CLEARING HOUSE IS A 1751 01:30:15,643 --> 01:30:17,578 GOOD IDEA. 1752 01:30:17,645 --> 01:30:20,081 >> THOSE ISSUES CAN BE WORKED 1753 01:30:20,148 --> 01:30:20,314 OUT. 1754 01:30:20,381 --> 01:30:21,449 FROM MY PERSPECTIVE, THE TIME 1755 01:30:21,516 --> 01:30:23,317 ELEMENT AND WHO IS TRACKING HOW 1756 01:30:23,384 --> 01:30:25,119 LONG THE STUDY TAKES TO ENROLL 1757 01:30:25,186 --> 01:30:26,487 IS AN ISSUE. 1758 01:30:26,554 --> 01:30:27,889 WITH THE SINGLE IRB I WANT TO 1759 01:30:27,955 --> 01:30:31,058 SAY SOME OF THAT TIME TO OPEN 1760 01:30:31,125 --> 01:30:32,426 THE SITE HAS CHANGED. 1761 01:30:32,493 --> 01:30:33,828 THERE'S DIFFERENT ISSUES ON BOTH 1762 01:30:33,895 --> 01:30:36,130 SIDES BUT IF WE'RE THINKING 1763 01:30:36,197 --> 01:30:37,765 ABOUT THAT NET GENERATION OF 1764 01:30:37,832 --> 01:30:42,637 STUDIES, THIS IS THE TIME TO SAY 1765 01:30:42,703 --> 01:30:44,272 WHAT WE'VE DONE TO NOW MAYBE 1766 01:30:44,338 --> 01:30:45,673 WORKS BUT WE CAN DO IT BETTER 1767 01:30:45,740 --> 01:30:46,240 AND HERE'S THINGS TO THINK 1768 01:30:46,307 --> 01:30:54,749 ABOUT. 1769 01:30:54,816 --> 01:30:59,821 THEY TALKED ABOUT PART NERGZ 1770 01:30:59,887 --> 01:31:06,561 WITH OTHER AND PARTNERING WITH 1771 01:31:06,627 --> 01:31:11,899 OTHERS WE DON'T TRADITIONALLY 1772 01:31:11,966 --> 01:31:14,235 PARTNER WITH AND THEY PART NERD 1773 01:31:14,302 --> 01:31:17,638 TO COMPLETE THE ACT NOW TRIALS. 1774 01:31:17,705 --> 01:31:19,574 WE HAVE EXPERIENCE. 1775 01:31:19,640 --> 01:31:25,112 IT'S SOMETHING THAT SHOULD BE 1776 01:31:25,179 --> 01:31:35,590 CONSIDERED AND IT'S NOT 1777 01:31:37,091 --> 01:31:39,727 IMPOSSIBLE TO THINK HOW DO WE 1778 01:31:39,794 --> 01:31:45,099 BRING ON SITES THAT DO NOT 1779 01:31:45,166 --> 01:31:46,234 CURRENTLY RECEIVE SUPPORT FROM 1780 01:31:46,300 --> 01:31:49,237 THE FOR THE INFRASTRUCTURE. 1781 01:31:49,303 --> 01:31:50,771 GREAT SUGGESTION AND WE CAN LOOK 1782 01:31:50,838 --> 01:31:52,907 AT WHERE THEY ARE AND WHERE THE 1783 01:31:52,974 --> 01:32:03,150 NEEDS ARE. 1784 01:32:06,354 --> 01:32:07,321 >> MAYBE IT WOULD BE INTEREST TO 1785 01:32:07,388 --> 01:32:09,123 THINK OF THE COMPONENTS OF THIS 1786 01:32:09,190 --> 01:32:10,791 RECOMMENDATION WE'RE TALKING 1787 01:32:10,858 --> 01:32:12,660 ABOUT EXPANSION OF NETWORKS TO 1788 01:32:12,727 --> 01:32:15,496 REALLY THINK ABOUT FOSTERING 1789 01:32:15,563 --> 01:32:16,764 PUBLIC-PRIVATE PARTNERSHIPS AND 1790 01:32:16,831 --> 01:32:19,166 HOW WE BETTER INCORPORATE IN 1791 01:32:19,233 --> 01:32:20,968 DIFFERENT STAKEHOLDER GROUPS 1792 01:32:21,035 --> 01:32:22,236 THAT MAY BE ABLE TO HELP 1793 01:32:22,303 --> 01:32:24,772 FACILITATE BRINGING SOME OF THE 1794 01:32:24,839 --> 01:32:26,240 NEW THERAPEUTIC DEVELOPMENTS 1795 01:32:26,307 --> 01:32:27,441 GOING FORWARD FROM TRANSLATIONAL 1796 01:32:27,508 --> 01:32:30,978 TO CLINICAL DEVELOPMENT. 1797 01:32:31,045 --> 01:32:33,314 I'M INTERESTED UP HEARING 1798 01:32:33,381 --> 01:32:34,849 THOUGHTS FROM THE GROUP ON WHAT 1799 01:32:34,916 --> 01:32:37,418 YOU HEARD ABOUT TODAY AND WHERE 1800 01:32:37,485 --> 01:32:40,021 WE TODAY AND MAY NEED TO 1801 01:32:40,087 --> 01:32:41,989 PROGRESS TO TO BEST FACILITATE 1802 01:32:42,056 --> 01:32:52,600 THE PUBLIC PRIVATE PARTNERSHIPS. 1803 01:32:59,073 --> 01:32:59,307 TINA. 1804 01:32:59,373 --> 01:33:01,475 >> I'M NOT SURE IF THIS WITH 1805 01:33:01,542 --> 01:33:07,481 WHERE YOU WERE GOING BUT THERE'S 1806 01:33:07,548 --> 01:33:10,251 GREAT OPPORTUNITY IN 1807 01:33:10,318 --> 01:33:12,520 PUBLIC-PRIVATE PARTNERSHIPS IN 1808 01:33:12,586 --> 01:33:17,625 LACTATION AND PREGNANCY AND 1809 01:33:17,692 --> 01:33:21,295 UNDER THE TERM EN IS THERE A 1810 01:33:21,362 --> 01:33:27,668 PROCESS IN PLACE OR IS ANYBODY 1811 01:33:27,735 --> 01:33:30,571 ENGAGED IN EDUCATING OR BRING 1812 01:33:30,638 --> 01:33:34,175 THIS ISSUE TO THE PRIVATE PART 1813 01:33:34,241 --> 01:33:35,743 OF THE PUBLIC-PRIVATE 1814 01:33:35,810 --> 01:33:36,410 PARTNERSHIP SO THEY CAN 1815 01:33:36,477 --> 01:33:39,180 APPRECIATE THE BENEFITS AND 1816 01:33:39,246 --> 01:33:40,982 GAINS THAT COULD BE APPRECIATED 1817 01:33:41,048 --> 01:33:43,851 BY ESTABLISHING THOSE KINDS OF 1818 01:33:43,918 --> 01:33:46,253 COLLABORATIONS TO FACILITATE 1819 01:33:46,320 --> 01:33:53,427 RESEARCH. 1820 01:33:53,494 --> 01:33:56,831 I WONDER IF IT HAPPENS BY 1821 01:33:56,897 --> 01:33:59,734 HAPPENSTANCE THAN PROMOTING SUCH 1822 01:33:59,800 --> 01:34:02,003 METHODS FOR GETTING THE WORK 1823 01:34:02,069 --> 01:34:02,870 DONE. 1824 01:34:02,937 --> 01:34:03,804 >> THANK YOU, TINA. 1825 01:34:03,871 --> 01:34:05,639 I DON'T WANT TO PUT COLLEAGUES 1826 01:34:05,706 --> 01:34:07,475 ON THE SPOT BUT I KNOW THERE ARE 1827 01:34:07,541 --> 01:34:13,047 SOME COLLEAGUES IN THE WORKING 1828 01:34:13,114 --> 01:34:16,117 GROUP PARTICIPATING IN THE 1829 01:34:16,183 --> 01:34:20,488 EUROPEAN CONCEPTION AND WANT TO 1830 01:34:20,554 --> 01:34:22,656 KNOW IF YOU CAN TALK ABOUT THAT 1831 01:34:22,723 --> 01:34:27,561 AND AS A MODEL TO ADDRESS THE 1832 01:34:27,628 --> 01:34:38,105 NEEDS SPECIFIC TO LACTATION? 1833 01:34:43,744 --> 01:34:45,980 NO ONE WANTS TO SPEAK, I GUESS. 1834 01:34:46,047 --> 01:34:48,416 I WONDER IF I CAN ASK MY 1835 01:34:48,482 --> 01:34:50,184 COLLEAGUE TO SPEAK WITH THE 1836 01:34:50,251 --> 01:34:52,119 ACTIVITIES HE'S WORKING ON AS A 1837 01:34:52,186 --> 01:34:52,820 WORK PACKAGE LEAD THROUGH 1838 01:34:52,887 --> 01:34:53,120 CONCEPTION. 1839 01:34:53,187 --> 01:35:03,330 >> SURE. 1840 01:35:04,498 --> 01:35:06,233 I'M WORKING ON THE PRECLINICAL 1841 01:35:06,300 --> 01:35:09,537 WORK PACKAGE FOR THE CONCEPTION 1842 01:35:09,603 --> 01:35:10,271 PROJECT. 1843 01:35:10,337 --> 01:35:14,241 WORK PACKAGE 3 IS TRYING TO 1844 01:35:14,308 --> 01:35:16,143 IDENTIFY AN ALTERNATIVE 1845 01:35:16,210 --> 01:35:19,246 PRE-CLINICAL MODEL TO LOOK AT 1846 01:35:19,313 --> 01:35:26,253 DRUG TRANSFER VIA LACTATION AND 1847 01:35:26,320 --> 01:35:30,257 LOOKING AT THE GUINEA PIG AS AN 1848 01:35:30,324 --> 01:35:33,994 ALTERNATIVE MODEL FROM THE MILK 1849 01:35:34,061 --> 01:35:34,628 COMPOSITION PERSPECTIVE IT'S 1850 01:35:34,695 --> 01:35:36,630 MOST SIMILAR TO SOME OF THE 1851 01:35:36,697 --> 01:35:38,933 SPECIES WE LOOKED AT TO HUMANS. 1852 01:35:38,999 --> 01:35:44,505 AND EVEN SOME OF THE PHYSIOLOGY 1853 01:35:44,572 --> 01:35:50,244 IS CLOSE TO THE HUMAN AND 1854 01:35:50,311 --> 01:35:52,546 LOOKING AT COMPOUNDS IN THE MINI 1855 01:35:52,613 --> 01:35:57,251 PIG TO COMPARE TO AVAILABLE 1856 01:35:57,318 --> 01:36:00,821 HUMAN DATA TO SEE IF THAT MODEL 1857 01:36:00,888 --> 01:36:02,590 IS TRANSLATABLE TO HUMAN DATA 1858 01:36:02,656 --> 01:36:03,090 ALREADY AVAILABLE. 1859 01:36:03,157 --> 01:36:05,459 IT'S LIMITED. 1860 01:36:05,526 --> 01:36:07,128 WE DON'T HAVE A LOT OF 1861 01:36:07,194 --> 01:36:07,394 COMPOUNDS. 1862 01:36:07,461 --> 01:36:09,697 THERE COULD BE CERTAIN MODAL 1863 01:36:09,763 --> 01:36:11,799 MODALITIES OF DRUGS BETTER 1864 01:36:11,866 --> 01:36:14,368 SUITED FOR USE IN THE MINI PIG 1865 01:36:14,435 --> 01:36:15,603 THAN OTHERS. 1866 01:36:15,669 --> 01:36:18,205 THAT COULD BE INVESTIGATED 1867 01:36:18,272 --> 01:36:19,173 POSTCONCEPTION PROJECT BUT WE'RE 1868 01:36:19,240 --> 01:36:19,840 LIMITED IN THE NUMBER OF 1869 01:36:19,907 --> 01:36:30,351 COMPOUNDS WE CAN LOOK AT. 1870 01:36:30,851 --> 01:36:34,822 WE'RE LOOKING AT COEFFICIENTS OF 1871 01:36:34,889 --> 01:36:39,493 DRUGS IN MAMMARY TISSUE AND ALSO 1872 01:36:39,560 --> 01:36:42,530 DEVELOPING PDPT MODELS TO 1873 01:36:42,596 --> 01:36:43,797 PREDICT DRUG EXPOSURE IN AN 1874 01:36:43,864 --> 01:36:46,233 INFANT THROUGH NURSING. 1875 01:36:46,300 --> 01:36:48,068 WE'RE LOOKING AT MATERNAL MODELS 1876 01:36:48,135 --> 01:36:50,638 AND MATERNAL INFANT MODELS TO 1877 01:36:50,704 --> 01:36:54,975 TRY TO DEVELOP MODEL CAN BE USED 1878 01:36:55,042 --> 01:36:56,410 AND WORK PACKAGE THREE IS GOING 1879 01:36:56,477 --> 01:36:58,913 TO EMA TRYING TO GET 1880 01:36:58,979 --> 01:37:00,981 QUALIFICATION ADVICE AND IF THE 1881 01:37:01,048 --> 01:37:02,883 DATA'S STRONG ENOUGH WE MAY BE 1882 01:37:02,950 --> 01:37:04,552 ABLE TO GET QUALIFICATION 1883 01:37:04,618 --> 01:37:04,919 OPINION. 1884 01:37:04,985 --> 01:37:07,154 IT'S GOING TO BE CHALLENGING 1885 01:37:07,221 --> 01:37:07,955 BECAUSE WE MAY NOT HAVE 1886 01:37:08,022 --> 01:37:09,924 SUFFICIENT DATA FOR THEM TO GIVE 1887 01:37:09,990 --> 01:37:11,258 US A QUALIFICATION OPINION 1888 01:37:11,325 --> 01:37:16,497 BECAUSE OF LIMITED TIME WE HAVE 1889 01:37:16,564 --> 01:37:18,832 BUT AT LEAST WE'LL HAVE 1890 01:37:18,899 --> 01:37:19,934 QUALIFICATION ADVICE AND 1891 01:37:20,000 --> 01:37:22,236 QUALIFICATIONS FROM EMA TO GET 1892 01:37:22,303 --> 01:37:22,970 FEEDBACK ON THE VARIOUS MODELS 1893 01:37:23,037 --> 01:37:31,979 WE'RE DEVELOPING. 1894 01:37:32,046 --> 01:37:37,218 >> THERE'S FUNDING THROUGH THE 1895 01:37:37,284 --> 01:37:39,787 PRIVATE SECTOR AND PUBLIC SECTOR 1896 01:37:39,853 --> 01:37:42,022 AND THIS PRODUCT IS ENTIRELY 1897 01:37:42,089 --> 01:37:43,057 DEDICATED TO LACTATION STUDIES 1898 01:37:43,123 --> 01:37:44,858 AND WONDERING IF I CAN PUT YOU 1899 01:37:44,925 --> 01:37:48,062 ON THE SPOT AGAIN. 1900 01:37:48,128 --> 01:37:52,700 TALK A LITTLE BIT TO WHAT SOME 1901 01:37:52,766 --> 01:37:53,667 OF THE DRIVING FORCE S ARE 1902 01:37:53,734 --> 01:37:55,269 BEHIND WHAT BROUGHT THE PUBLIC 1903 01:37:55,336 --> 01:37:56,470 SECTOR TO THE TABLE AND WHAT 1904 01:37:56,537 --> 01:37:58,138 WERE THINGS THAT LED THE PRIVATE 1905 01:37:58,205 --> 01:38:00,374 SECTOR TO SAY WE WANT TO HAVE 1906 01:38:00,441 --> 01:38:02,977 THIS PARTNERSHIP? 1907 01:38:03,043 --> 01:38:04,445 THIS MAY HELP INFORM PERHAPS 1908 01:38:04,511 --> 01:38:05,613 SOME OF THE DISCUSSION AS A 1909 01:38:05,679 --> 01:38:10,751 WORKING GROUP WE MAY WANT TO PUT 1910 01:38:10,818 --> 01:38:12,786 INTO OUR REPORT BACK TO CONGRESS 1911 01:38:12,853 --> 01:38:14,221 WITH ADDITIONAL WORK IN THE 1912 01:38:14,288 --> 01:38:14,421 SPACE. 1913 01:38:14,488 --> 01:38:20,561 >> FROM MY PERSPECTIVE, I WAS 1914 01:38:20,628 --> 01:38:24,732 ONE OF THE TWO INDIVIDUALS THAT 1915 01:38:24,798 --> 01:38:27,601 STARTED IT OUT AND IT STARTED AS 1916 01:38:27,668 --> 01:38:30,838 A PRE CLINICAL PROJECT BUT AS WE 1917 01:38:30,904 --> 01:38:32,940 STARTED TO DISCUSS WITH OTHER 1918 01:38:33,007 --> 01:38:34,742 PRIVATE PARTNERS AND PUBLIC 1919 01:38:34,808 --> 01:38:36,210 PARTNERS IT QUICKLY GREW INTO 1920 01:38:36,277 --> 01:38:38,245 WHAT IT IS TODAY WITH MULTIPLE 1921 01:38:38,312 --> 01:38:40,814 WORK PACKAGES LOOKING AT MILK 1922 01:38:40,881 --> 01:38:43,517 BIO BANKS, CLINICAL TRIALS, 1923 01:38:43,584 --> 01:38:43,917 EVERYTHING. 1924 01:38:43,984 --> 01:38:46,253 IT BALLOONED INTO WHAT IT IS 1925 01:38:46,320 --> 01:38:48,222 TODAY. 1926 01:38:48,289 --> 01:38:53,294 I THINK SOME IMPETUS BEHIND IT 1927 01:38:53,360 --> 01:38:54,862 IS THERE'S DATA GAPS WHEN WE ARE 1928 01:38:54,928 --> 01:38:59,933 DEVELOPING DRUGS AND ONE OF 1929 01:39:00,000 --> 01:39:02,069 WHICH IS THE LACTATION ASPECT 1930 01:39:02,136 --> 01:39:02,569 FOR OUR LABELS. 1931 01:39:02,636 --> 01:39:08,475 WE TYPICALLY DO NOT COLLECT ANY 1932 01:39:08,542 --> 01:39:10,944 DATA IN OUR ANIMAL MODELS OR 1933 01:39:11,011 --> 01:39:13,614 LIMITED DATA WITH RESPECT TO 1934 01:39:13,681 --> 01:39:16,917 DRUG TRANSFER VIA THE MILK INTO 1935 01:39:16,984 --> 01:39:27,227 THE OFFSPRING. 1936 01:39:29,663 --> 01:39:33,033 WITHOUT THAT IT HANDCUFFS TO THE 1937 01:39:33,100 --> 01:39:33,801 RECOMMENDATIONS WHETHER IT'S 1938 01:39:33,867 --> 01:39:34,435 SAFE OR NOT. 1939 01:39:34,501 --> 01:39:36,637 ONE REASON WE ENTERED INTO THIS 1940 01:39:36,704 --> 01:39:39,440 IS TO TRY TO HELP FILL THAT GAP 1941 01:39:39,506 --> 01:39:41,842 AND COME UP WITH A MODEL SYSTEM 1942 01:39:41,909 --> 01:39:43,644 THAT IS USABLE AND TRANSLATABLE 1943 01:39:43,711 --> 01:39:46,480 TO HUMANS TO PROVIDE SOME DATA 1944 01:39:46,547 --> 01:39:50,250 OR INFORMATION IN OUR LABELS AT 1945 01:39:50,317 --> 01:39:54,054 THE TIME OF DRUG APPROVAL THAT 1946 01:39:54,121 --> 01:39:59,193 WOULD BE USEFUL TO A PHYSICIAN 1947 01:39:59,259 --> 01:40:01,662 TO USE THE DRUG AND ASSUME 1948 01:40:01,729 --> 01:40:04,198 WITHIN THE OTHER WORK PACKAGES 1949 01:40:04,264 --> 01:40:09,470 IT'S ALSO SIMILAR. 1950 01:40:09,536 --> 01:40:11,004 IT'S TRYING TO GET THE HUMAN 1951 01:40:11,071 --> 01:40:21,648 DATA THAT WOULD BE USEFUL AND 1952 01:40:21,715 --> 01:40:22,516 PROVIDE DIFFERENT DATA WE WOULD 1953 01:40:22,583 --> 01:40:26,220 NOT BE ABLE TO GET FROM ANIMAL 1954 01:40:26,286 --> 01:40:26,453 MODELS. 1955 01:40:26,520 --> 01:40:29,390 >> IT'S IMPORTANT TO SHARE WHAT 1956 01:40:29,456 --> 01:40:31,291 MAY BE THE WAYS TO BE AN 1957 01:40:31,358 --> 01:40:33,727 ENTICEMENT OR INDUCEMENT TO BE 1958 01:40:33,794 --> 01:40:34,928 COLLABORATIVE OPPORTUNITIES FOR 1959 01:40:34,995 --> 01:40:36,530 PUBLIC-PRIVATE PARTNERSHIP. 1960 01:40:36,597 --> 01:40:40,534 I'M INTERESTED IN AARON. 1961 01:40:40,601 --> 01:40:41,969 I'LL ASK A QUESTION TO YOU DO 1962 01:40:42,035 --> 01:40:46,240 YOU SEE IN THE WORK BEING DONE 1963 01:40:46,306 --> 01:40:48,809 ON YOUR SIDE WHERE THERE'S SOME 1964 01:40:48,876 --> 01:40:50,244 OPPORTUNITIES TO EXPAND BEYOND 1965 01:40:50,310 --> 01:40:51,445 TO THINK WHERE THERE MAY BE 1966 01:40:51,512 --> 01:40:53,347 COMMON GROUNDS TO BEGIN TO DO 1967 01:40:53,414 --> 01:40:57,284 SOME OF THE BROADER 1968 01:40:57,351 --> 01:41:00,020 PUBLIC-PRIVATE PARTNERING I KNOW 1969 01:41:00,087 --> 01:41:02,856 THROUGH FNIH THERE'S A WAY TO 1970 01:41:02,923 --> 01:41:04,825 ESTABLISH IT QUITE EFFECTIVELY 1971 01:41:04,892 --> 01:41:05,559 BUT WONDERING IF THERE'S 1972 01:41:05,626 --> 01:41:06,193 SOMETHING YOU'D LIKE TO SPEAK TO 1973 01:41:06,260 --> 01:41:16,370 THERE. 1974 01:41:19,106 --> 01:41:22,042 THE FOUNDATION FOR THE NIH IS 1975 01:41:22,109 --> 01:41:27,448 INTERESTED IN EXPANDING CLINICAL 1976 01:41:27,514 --> 01:41:33,086 HEALTH AND EXPANDING THAT IS A 1977 01:41:33,153 --> 01:41:34,922 POTENTIAL AND MOSTLY IN THE DRUG 1978 01:41:34,988 --> 01:41:40,294 TARGET VALIDATION AND 1979 01:41:40,360 --> 01:41:46,233 DEVELOPMENT SPACE ONE OF THE 1980 01:41:46,300 --> 01:41:47,601 CHALLENGES IN DISCUSSING 1981 01:41:47,668 --> 01:41:50,037 LACTATION OR PREGNANCY IN REGARD 1982 01:41:50,103 --> 01:41:52,072 TO PUBLIC-PRIVATE PARTNERSHIPS 1983 01:41:52,139 --> 01:41:54,241 IS IDENTIFYING THE INDIVIDUALS 1984 01:41:54,308 --> 01:41:55,909 WITHIN A CONDITION THAT ARE 1985 01:41:55,976 --> 01:42:01,181 CHAMPIONS FOR THIS KIND OF 1986 01:42:01,248 --> 01:42:04,585 RESEARCH. 1987 01:42:04,651 --> 01:42:06,787 I MAY KNOW AN INDIVIDUAL IS 1988 01:42:06,854 --> 01:42:08,889 DOING SOMETHING OR VERY 1989 01:42:08,956 --> 01:42:10,257 DEVELOPED IN LACTATION RESEARCH 1990 01:42:10,324 --> 01:42:11,325 AND REPRESENTATIVES FROM THE 1991 01:42:11,391 --> 01:42:12,826 SAME COMPANY WILL SAY WELL, 1992 01:42:12,893 --> 01:42:17,998 THAT'S SOMETHING THE COMPANY'S 1993 01:42:18,065 --> 01:42:21,902 NOT INTERESTED IN. 1994 01:42:21,969 --> 01:42:25,739 THAT MAY BE SOMETHING TO FIND 1995 01:42:25,806 --> 01:42:28,675 THOSE WILLING TO COME TO THE 1996 01:42:28,742 --> 01:42:31,178 TABLE AS CONVENERS AND 1997 01:42:31,245 --> 01:42:31,912 COMPLEMENTARY WILL PROVIDE A 1998 01:42:31,979 --> 01:42:42,523 GREAT VENUE FOR THAT SPACE AND 1999 01:42:42,823 --> 01:42:44,491 THERE'LL BE A GREAT OPPORTUNITY 2000 01:42:44,558 --> 01:42:45,325 AND THROUGH THAT PERHAPS WE CAN 2001 01:42:45,392 --> 01:42:50,964 START TO BUILD UP MORE OF A 2002 01:42:51,031 --> 01:42:54,234 COALITION OF DEVELOPS THAT 2003 01:42:54,301 --> 01:42:56,236 REPRESENT COMPANIES WILLING TO 2004 01:42:56,303 --> 01:42:57,738 ENGAGE AND ENGAGE IN THE PRIVATE 2005 01:42:57,804 --> 01:42:58,939 SIDE OF THE PUBLIC-PRIVATE 2006 01:42:59,006 --> 01:42:59,806 PARTNERSHIPS. 2007 01:42:59,873 --> 01:43:10,183 >> THANKS, AARON. 2008 01:43:15,689 --> 01:43:18,492 >> THERE'S DISEASE-BASED 2009 01:43:18,559 --> 01:43:19,092 REGISTRIES. 2010 01:43:19,159 --> 01:43:23,330 A SINGLE-DRUG BASED REGISTRY WE 2011 01:43:23,397 --> 01:43:30,837 HEARD ABOUT RECRUITMENT AND HOW 2012 01:43:30,904 --> 01:43:32,105 LONG IT TAKES. 2013 01:43:32,172 --> 01:43:34,741 I WANTED TO REITERATE THERE'S 2014 01:43:34,808 --> 01:43:36,410 ANY OPPORTUNITY FOR 2015 01:43:36,476 --> 01:43:37,444 COLLABORATION ACROSS THE BOARD 2016 01:43:37,511 --> 01:43:39,212 IN THE PUBLIC PRIVATE SECTOR 2017 01:43:39,279 --> 01:43:40,948 WHICH MAY ALLOW US TO GET MORE 2018 01:43:41,014 --> 01:43:47,087 INFORMATION . 2019 01:43:47,154 --> 01:43:47,487 THANK YOU. 2020 01:43:47,554 --> 01:43:49,389 I APOLOGIZE I CHIMED IN AND MAY 2021 01:43:49,456 --> 01:43:59,766 HAVE INTERRUPTED. 2022 01:44:14,881 --> 01:44:16,650 >> ONE OF THE OPPORTUNITIES I 2023 01:44:16,717 --> 01:44:21,989 SEE IN THE CHAT TOO ABOUT THE 2024 01:44:22,055 --> 01:44:27,027 FINE LINE BETWEEN WHAT WOULD BE 2025 01:44:27,094 --> 01:44:34,234 PUBLICLY FUNDED OR INDUSTRY 2026 01:44:34,301 --> 01:44:41,675 REQUIRED CONVENERS THAT EXIST 2027 01:44:41,742 --> 01:44:43,644 AND THE CRITICAL PATH INSTITUTE. 2028 01:44:43,710 --> 01:44:46,780 I WONDER IF THAT'S A WAY TO 2029 01:44:46,847 --> 01:44:51,852 BRING PEOPLE TOGETHER AND IT 2030 01:44:51,918 --> 01:45:00,494 SEEMS WITH A PLATFORM THAT COULD 2031 01:45:00,560 --> 01:45:06,566 BE CONSIDERED TO CREATE A PLACE 2032 01:45:06,633 --> 01:45:08,068 WHERE THOSE CAN CONTRIBUTE TO 2033 01:45:08,135 --> 01:45:10,737 THE IDEA OF A DISEASE-BASED 2034 01:45:10,804 --> 01:45:11,004 REGISTRY. 2035 01:45:11,071 --> 01:45:12,039 I DON'T THINK WHERE WE'RE GOING 2036 01:45:12,105 --> 01:45:21,748 TO GET TO BE WITHOUT IT. 2037 01:45:21,815 --> 01:45:22,949 I WOULD THINK THE COMMITTEE 2038 01:45:23,016 --> 01:45:25,519 WOULD WANT TO PUT FORWARD AS A 2039 01:45:25,585 --> 01:45:26,520 RECOMMENDATION SOME WAYS THAT 2040 01:45:26,586 --> 01:45:29,389 COULD DIRECTLY BE USED TO START 2041 01:45:29,456 --> 01:45:29,923 AND CREATE DISEASE-BASED 2042 01:45:29,990 --> 01:45:40,200 REGISTRIES. 2043 01:45:40,400 --> 01:45:43,270 AND MODELS LIKE THE IMI 2044 01:45:43,336 --> 01:45:53,780 CONCEPTION ARE AN EXAMPLE. 2045 01:45:55,048 --> 01:45:57,484 >> TWO THINGS ON LACTATION AND 2046 01:45:57,551 --> 01:45:57,784 HUMAN MILK. 2047 01:45:57,851 --> 01:46:00,754 THE QUESTION OF WHAT IS THE 2048 01:46:00,821 --> 01:46:03,190 EFFECTS NOT ONLY OF THE DRUGS IN 2049 01:46:03,256 --> 01:46:07,360 MILK BUT THE OF TAKING THAT 2050 01:46:07,427 --> 01:46:15,001 MEDICATION ON THE MUMAN M -- HU 2051 01:46:15,068 --> 01:46:16,470 MILK SUPPLY AND I'M NOT AWARE OF 2052 01:46:16,536 --> 01:46:21,174 MUCH OUTSIDE THE MPRINT HUB AND 2053 01:46:21,241 --> 01:46:22,609 I'M FOCUSSED ON THAT AND MAYBE 2054 01:46:22,676 --> 01:46:28,148 OTHERS CAN COMMENT ON THAT AS 2055 01:46:28,215 --> 01:46:28,815 WELL. 2056 01:46:28,882 --> 01:46:29,783 IT'S IMPORTANT. 2057 01:46:29,850 --> 01:46:32,419 AT THE LAST MPRINT MEETING SOME 2058 01:46:32,486 --> 01:46:34,221 COLLEAGUES RAISED IT UP AND WE 2059 01:46:34,287 --> 01:46:38,325 COULD IDENTIFY SOME TYPE OF 2060 01:46:38,391 --> 01:46:41,461 BIOMARKER OR RELATIVELY SIMPLE 2061 01:46:41,528 --> 01:46:42,996 ASSESSMENT FOR MILK QUALITY AND 2062 01:46:43,063 --> 01:46:43,196 LEVEL. 2063 01:46:43,263 --> 01:46:47,534 I DON'T THINK IT'S THE FULL 2064 01:46:47,601 --> 01:46:51,938 EXTENSIVE METABOLOMICS YOU CAN 2065 01:46:52,005 --> 01:46:53,106 DO IN THE LAB. 2066 01:46:53,173 --> 01:46:54,908 AND JULIE RAISED THIS EARLIER IN 2067 01:46:54,975 --> 01:46:58,411 TERMS OF THE OVERSEEING IN TERMS 2068 01:46:58,478 --> 01:47:00,847 OF THE LAC, THERE'S NOT AS MANY 2069 01:47:00,914 --> 01:47:02,249 APPLICATIONS LOOKING AT 2070 01:47:02,315 --> 01:47:05,719 THERAPEUTICS RELATED TO 2071 01:47:05,786 --> 01:47:06,353 LACTATION. 2072 01:47:06,419 --> 01:47:09,022 I THINK THAT GETS TO MILK SUPPLY 2073 01:47:09,089 --> 01:47:10,991 QUALITY AND CONDITIONS LIKE 2074 01:47:11,057 --> 01:47:16,496 MASTITIS THAT MAY OCCUR DURING 2075 01:47:16,563 --> 01:47:19,499 LACTATION. 2076 01:47:19,566 --> 01:47:22,969 WE MAY NEED TO LOOK CLOSER TO 2077 01:47:23,036 --> 01:47:24,671 UNDERSTAND WHY THINGS AREN'T 2078 01:47:24,738 --> 01:47:25,939 MOVING FORWARD THERE AND ONE 2079 01:47:26,006 --> 01:47:29,276 PART MAY BE THE LACK OF -- 2080 01:47:29,342 --> 01:47:30,677 LACTATION AND ISSUES WITH 2081 01:47:30,744 --> 01:47:32,979 LACTATION I DON'T THINK ARE 2082 01:47:33,046 --> 01:47:34,948 CAPTURED OR EXTRACTED AS WELL 2083 01:47:35,015 --> 01:47:38,685 FROM EHRs AND THERE MAY BE NOT 2084 01:47:38,752 --> 01:47:41,555 AS MUCH TRACKING AND HOW DOES 2085 01:47:41,621 --> 01:47:43,123 ONE ASSESS QUALITY OF HUMAN 2086 01:47:43,190 --> 01:47:43,323 MILK. 2087 01:47:43,390 --> 01:47:46,226 THE OVER ALL LACK OF STUDY ON 2088 01:47:46,293 --> 01:47:50,897 LACTATION MAY BE ONE OF THE 2089 01:47:50,964 --> 01:47:59,439 DRIVERS OR INHIBITERS WITH 2090 01:47:59,506 --> 01:48:01,675 TARGET VALIDATION. 2091 01:48:01,741 --> 01:48:03,376 THAT MAY BE A CONSIDERATION FOR 2092 01:48:03,443 --> 01:48:04,344 WHAT ADDITIONAL RECOMMENDATIONS 2093 01:48:04,411 --> 01:48:05,045 MAY BE. 2094 01:48:05,111 --> 01:48:05,979 >> I APPRECIATE THOSE ADDITIONAL 2095 01:48:06,046 --> 01:48:06,313 COMMENTS. 2096 01:48:06,379 --> 01:48:12,018 I WANT TO ACKNOWLEDGE THERE WAS 2097 01:48:12,085 --> 01:48:19,259 A COMMENT IN TERMS OF THE AFFECT 2098 01:48:19,326 --> 01:48:21,995 TRANSFER OF THERAPEUTIC TO THE 2099 01:48:22,062 --> 01:48:23,964 MILK VERSUS LOW MILK SUPPLY. 2100 01:48:24,030 --> 01:48:29,502 THAT'S AN IMPORTANT POINT WELL 2101 01:48:29,569 --> 01:48:29,703 TAKEN. 2102 01:48:29,769 --> 01:48:38,078 IT'S ALSO HIGHLIGHT ED AND WE'R 2103 01:48:38,144 --> 01:48:42,115 NOT LIMITING IT TO WHETHER OR 2104 01:48:42,182 --> 01:48:46,219 NOT THERE'S NEEDS WITHIN THE 2105 01:48:46,286 --> 01:48:49,189 LACTATION COMMUNITY. 2106 01:48:49,256 --> 01:48:50,423 OTHER COMMENTS FOR DISCUSSION. 2107 01:48:50,490 --> 01:48:56,696 THERE WERE OTHER ASPECTS TO 2108 01:48:56,763 --> 01:49:07,140 THESE RECOMMENDATIONS. 2109 01:49:10,577 --> 01:49:13,647 AND THINK OF EFFECTIVENESS 2110 01:49:13,713 --> 01:49:18,919 TRIALS OR CASE CONTROL STUDIES. 2111 01:49:18,985 --> 01:49:20,453 I DON'T KNOW IF ANYONE WANTS TO 2112 01:49:20,520 --> 01:49:21,688 ADDRESS THE ASPECTS OF HOW TO 2113 01:49:21,755 --> 01:49:32,299 THINK ABOUT GENERATING THE DATA. 2114 01:49:49,482 --> 01:49:50,750 WE ARE ASKING INDIVIDUALS TO 2115 01:49:50,817 --> 01:49:54,254 THINK OF INNOVATIVE DESIGNS AS 2116 01:49:54,321 --> 01:50:00,760 THEY PROPOSE THEIR IDEAS AND SO 2117 01:50:00,827 --> 01:50:02,228 THAT'S SOMETHING NICHD IS 2118 01:50:02,295 --> 01:50:04,764 ENCOURAGING THINKING ABOUT 2119 01:50:04,831 --> 01:50:06,199 INNOVATIVE DESIGNS PLATFORM 2120 01:50:06,266 --> 01:50:07,467 TRIALS AND THINK OF THAT NATURE 2121 01:50:07,534 --> 01:50:13,340 THAT COULD POTENTIALLY BE -- 2122 01:50:13,406 --> 01:50:14,240 >> THANK YOU. 2123 01:50:14,307 --> 01:50:22,983 GO AHEAD. 2124 01:50:23,049 --> 01:50:24,751 >> A LITTLE BIT ABOUT CASE 2125 01:50:24,818 --> 01:50:31,524 CONTROL STUDIES, WITH MORE OF A 2126 01:50:31,591 --> 01:50:32,125 LACTAT 2127 01:50:32,192 --> 01:50:33,927 LACTATION HAT ON, I DON'T KNOW 2128 01:50:33,994 --> 01:50:35,795 IF WE IDENTIFIED WAYS TO STUDY 2129 01:50:35,862 --> 01:50:38,064 LACTATION OR LACK OF MILK 2130 01:50:38,131 --> 01:50:39,366 PRODUCTION, FOR INSTANCE SO WE 2131 01:50:39,432 --> 01:50:42,402 COULD DO CASE CONTROL STUDIES 2132 01:50:42,469 --> 01:50:43,236 THERE JUST YET. 2133 01:50:43,303 --> 01:50:48,908 IF WE ASSUME THE CASE WOULD BE A 2134 01:50:48,975 --> 01:50:52,979 WOMAN WITH LOW OR NO MILK 2135 01:50:53,046 --> 01:50:55,749 PRODUCTION. 2136 01:50:55,815 --> 01:50:58,885 THAT WOULD BE CHALLENGING BUT 2137 01:50:58,952 --> 01:51:04,958 FOR BIRTH DEFECTS AND STILLBORN 2138 01:51:05,025 --> 01:51:06,159 WE'RE LOOKING AT MEDICATION USE 2139 01:51:06,226 --> 01:51:10,630 AND PREGNANCY. 2140 01:51:10,697 --> 01:51:11,631 THAT'S IN RESPONSE TO THE CASE 2141 01:51:11,698 --> 01:51:20,407 CONTROL QUESTION. 2142 01:51:20,473 --> 01:51:23,576 >> I'D LIKE TO FOLLOW THE 2143 01:51:23,643 --> 01:51:32,285 COMMENT IN THE WORK I DO -- 2144 01:51:32,352 --> 01:51:39,726 >> I GUESS THAT WOULD BRANDON 2145 01:51:39,793 --> 01:51:40,026 BECOMES -- 2146 01:51:40,093 --> 01:51:41,728 >> WORKING WITH ELECTRONIC 2147 01:51:41,795 --> 01:51:42,662 HEALTH RECORD IT WOULD BE 2148 01:51:42,729 --> 01:51:44,831 DESIRABLE BUT IT'S DIFFICULT TO 2149 01:51:44,898 --> 01:51:49,135 CAPTURE ADEQUATE INFORMATION ON 2150 01:51:49,202 --> 01:51:55,108 LACTATION BECAUSE IT'S A DYNAMIC 2151 01:51:55,175 --> 01:52:01,281 PROCESS AND TO GATHER 2152 01:52:01,347 --> 01:52:05,985 INFORMATION THAT'S MEANING FFULN 2153 01:52:06,052 --> 01:52:08,488 AN ELECTRONIC HEALTH RECORDED 2154 01:52:08,555 --> 01:52:10,457 NOT SIMPLE AND YOU HAVE TO ASK 2155 01:52:10,523 --> 01:52:13,493 YOURSELF WHAT YOU'RE GOING TO 2156 01:52:13,560 --> 01:52:14,961 INTERPRET FROM THAT POINT IN 2157 01:52:15,028 --> 01:52:15,728 TIME FROM THAT ONE RECORD. 2158 01:52:15,795 --> 01:52:25,839 I WANTED TO POINT THAT OUT. 2159 01:52:25,905 --> 01:52:28,975 I'M NOT SURE WE FOUND THE MOST 2160 01:52:29,042 --> 01:52:32,645 FRUITFUL WAY TO STUDY. 2161 01:52:32,712 --> 01:52:34,547 >> I THINK WHAT I'M HEARING FROM 2162 01:52:34,614 --> 01:52:36,449 THE LAST TWO COMMENTS IS THERE 2163 01:52:36,516 --> 01:52:38,685 MAY BE DIFFERENT TRIAL DESIGN 2164 01:52:38,751 --> 01:52:40,987 NEEDS BETWEEN PREGNANCY 2165 01:52:41,054 --> 01:52:42,288 THERAPEUTIC STUDIES AND 2166 01:52:42,355 --> 01:52:44,023 LACTATION THERAPEUTIC STUDIES 2167 01:52:44,090 --> 01:52:45,525 AND NEED TO BE CLEAR ABOUT THAT 2168 01:52:45,592 --> 01:52:49,696 WHEN WE'RE PROVIDING OUR 2169 01:52:49,762 --> 01:52:50,096 PROGRESS REPORT. 2170 01:52:50,163 --> 01:52:55,535 GO AHEAD, TONY. 2171 01:52:55,602 --> 01:53:02,475 >> TO FOLLOW UP WITH RESPECT TO 2172 01:53:02,542 --> 01:53:07,647 RELATIONSHIPS WITH INDUSTRY. 2173 01:53:07,714 --> 01:53:08,515 I'D QUANTITY TO KNOW WHAT 2174 01:53:08,581 --> 01:53:13,753 PROGRESS IS BEING MADE WITH 2175 01:53:13,820 --> 01:53:16,623 RESPECT TO TRYING TO UNDERSTAND 2176 01:53:16,689 --> 01:53:19,826 THE DATA NEEDED FOR PREGNANT AND 2177 01:53:19,893 --> 01:53:22,996 LACTATING WOMEN DURING CLINICAL 2178 01:53:23,062 --> 01:53:23,229 TRIALS. 2179 01:53:23,296 --> 01:53:26,232 IT GOES HAND IN HAND WITH THE 2180 01:53:26,299 --> 01:53:29,536 EFFORTS FROM THE ICH AND THERE'S 2181 01:53:29,602 --> 01:53:32,305 DISCUSSION FROM PHARMA IN TRYING 2182 01:53:32,372 --> 01:53:35,909 TO INCLUDE PREGNANT WOMEN. 2183 01:53:35,975 --> 01:53:39,045 NOT PRESSURE BUT DESIRE FOR THE 2184 01:53:39,112 --> 01:53:40,413 INDUSTRIES TO GET THERE. 2185 01:53:40,480 --> 01:53:42,815 JUST WANTED TO SEE WHAT MIGHT BE 2186 01:53:42,882 --> 01:53:43,983 ALREADY IN THE WORK WITH RESPECT 2187 01:53:44,050 --> 01:53:53,026 TO INDUSTRY PARTNERSHIPS. 2188 01:53:53,092 --> 01:53:55,929 >> GO AHEAD, AARON, THANK YOU. 2189 01:53:55,995 --> 01:53:59,799 >> I WOULD MAYBE ADDRESS SOME OF 2190 01:53:59,866 --> 01:54:01,868 THAT FROM AT LEAST FROM WHAT I'M 2191 01:54:01,935 --> 01:54:02,235 SEEING. 2192 01:54:02,302 --> 01:54:04,103 THE FOUNDATION OF THE NIH IS 2193 01:54:04,170 --> 01:54:05,004 VERY INTERESTED IN BUILDING THAT 2194 01:54:05,071 --> 01:54:11,377 OUT AND IN TERM OF THEIR 2195 01:54:11,444 --> 01:54:14,113 RECRUITMENT FOR FUNDING FOR THE 2196 01:54:14,180 --> 01:54:17,016 PREECLAMPSIA PROJECT IS PART OF 2197 01:54:17,083 --> 01:54:20,853 THAT. 2198 01:54:20,920 --> 01:54:23,456 FINDING VENUES TO TALK ABOUT THE 2199 01:54:23,523 --> 01:54:28,494 IDENTIFIED CHAMPIONS IS GOING TO 2200 01:54:28,561 --> 01:54:29,362 BE IMPORTANT. 2201 01:54:29,429 --> 01:54:31,965 ONE THING THAT WAS DISCUSSED THE 2202 01:54:32,031 --> 01:54:34,701 NATIONAL ACADEMY OF SCIENCES IS 2203 01:54:34,767 --> 01:54:37,670 CONDUCTING A STUDY TO ADDRESS 2204 01:54:37,737 --> 01:54:38,972 MEDICAL AND LEGAL ISSUES AROUND 2205 01:54:39,038 --> 01:54:40,440 THIS AND HAVING THOSE ADDRESSED 2206 01:54:40,506 --> 01:54:44,310 IS A KEY COMPONENT TO GETTING 2207 01:54:44,377 --> 01:54:54,220 MORE PRIVATE SECTOR ENGAGEMENT. 2208 01:54:54,287 --> 01:54:58,157 THE NATIONAL ACADEMY IS A GOOD 2209 01:54:58,224 --> 01:55:00,627 VENUE AND THERE'S VARIOUS VENUES 2210 01:55:00,693 --> 01:55:03,763 AND THE DEVELOPMENT AND 2211 01:55:03,830 --> 01:55:04,864 TRANSLATION IS A GOOD ONE TO 2212 01:55:04,931 --> 01:55:08,701 HAVE THE DISCUSSIONS END AND TO 2213 01:55:08,768 --> 01:55:11,471 ADD TO YAO'S COMMENTS IN 2214 01:55:11,537 --> 01:55:15,375 THINKING HOW TO START THE 2215 01:55:15,441 --> 01:55:16,309 DIALOGUES SOONER RATHER THAN 2216 01:55:16,376 --> 01:55:17,644 LATER AND I DON'T KNOW IF OTHERS 2217 01:55:17,710 --> 01:55:22,215 HAVE ADDITIONAL THOUGHTS 2218 01:55:22,282 --> 01:55:22,849 ESPECIALLY THOSE IN THE PRIVATE 2219 01:55:22,915 --> 01:55:32,091 SECTOR. 2220 01:55:32,158 --> 01:55:35,461 >> HI, TO THE CHAIRS AND TO 2221 01:55:35,528 --> 01:55:36,929 EVERYONE FOR THIS IMPORTANT 2222 01:55:36,996 --> 01:55:37,397 DISCUSSION. 2223 01:55:37,463 --> 01:55:39,098 I HAD A QUESTION THAT'S A LITTLE 2224 01:55:39,165 --> 01:55:40,767 BIT DIFFERENT FROM SOME OF THE 2225 01:55:40,833 --> 01:55:42,802 TOPICS THAT WERE JUST RAISED SO 2226 01:55:42,869 --> 01:55:44,871 HAPPY TO TABLE IT OR TALK ABOUT 2227 01:55:44,937 --> 01:55:45,605 IT IN THE CHAT OR A DIFFERENT 2228 01:55:45,672 --> 01:55:50,643 TIME OFFLINE. 2229 01:55:50,710 --> 01:55:53,212 FOR ME LOOKING GLOBALLY IT SEEMS 2230 01:55:53,279 --> 01:55:54,914 FOR ALL THE RECOMMENDATIONS 2231 01:55:54,981 --> 01:55:57,250 THERE'S BEEN GOOD ADVANCEMENTS 2232 01:55:57,317 --> 01:55:59,018 TALKING ABOUT THE CHARGE OF THE 2233 01:55:59,085 --> 01:55:59,752 COUNCIL AND IF IMPLEMENTATION 2234 01:55:59,819 --> 01:56:02,155 STEPS HAVE BEEN TAKEN AND SEEMS 2235 01:56:02,221 --> 01:56:04,524 THERE'S PROGRESS IN GOOD AREAS. 2236 01:56:04,590 --> 01:56:07,327 ONE CONCEPTUAL AREA I STRUGGLE 2237 01:56:07,393 --> 01:56:09,262 TO FIND LANGUAGE OR 2238 01:56:09,329 --> 01:56:10,563 IMPLEMENTATION PLAN OR MAYBE 2239 01:56:10,630 --> 01:56:12,398 COMMENTS DURING THIS MORNING 2240 01:56:12,465 --> 01:56:13,733 RELATING TO RECOMMENDATION TWO 2241 01:56:13,800 --> 01:56:16,869 AND TO RECOMMENDATION NINE 2242 01:56:16,936 --> 01:56:18,738 SIMULATING NEW NOVEL DRUG 2243 01:56:18,805 --> 01:56:21,307 DISCOVERY MAYBE THE POINT AT 2244 01:56:21,374 --> 01:56:22,175 WHICH DRUG DISCOVERY BECOMES 2245 01:56:22,241 --> 01:56:22,775 DRUG ROLLOUT. 2246 01:56:22,842 --> 01:56:29,916 WHEN YOU HAVE SOMETHING THAT HAS 2247 01:56:29,982 --> 01:56:35,722 GOOD DATA LOU TO MOVE FORWARD TO 2248 01:56:35,788 --> 01:56:37,090 DRUG DELIVERY. 2249 01:56:37,156 --> 01:56:38,624 I UNDERSTAND THERE'S WELL 2250 01:56:38,691 --> 01:56:43,796 ESTABLISHED GUIDELINE FOR DRUG 2251 01:56:43,863 --> 01:56:50,470 DELIVERY BY THE NIH IT FEELS 2252 01:56:50,536 --> 01:56:54,207 LIKE THERE MAY BE IMPLICIT BIAS 2253 01:56:54,273 --> 01:56:57,610 TOWARDS HOLDING BACK THERAPEUTIC 2254 01:56:57,677 --> 01:57:01,114 MEASURES AND HOW DO WE THINK 2255 01:57:01,180 --> 01:57:06,219 ABOUT CREATING OR INCENTIVIZING 2256 01:57:06,285 --> 01:57:07,487 OR RELATING MORE TO THE QUESTION 2257 01:57:07,553 --> 01:57:10,957 BY THE PRIOR COMMENTER PUSHING 2258 01:57:11,023 --> 01:57:12,925 FORWARD TO STOP OURSELVES FROM 2259 01:57:12,992 --> 01:57:14,594 HOLDING BACK EFFECTIVE OR NOVEL 2260 01:57:14,660 --> 01:57:15,228 DRUGS. 2261 01:57:15,294 --> 01:57:16,796 THAT WAS AN AREA I WAS CURIOUS 2262 01:57:16,863 --> 01:57:18,531 ABOUT AND MAYBE THE CHAIRS CAN 2263 01:57:18,598 --> 01:57:19,298 LET ME KNOW THIS WILL BE TALKED 2264 01:57:19,365 --> 01:57:20,199 ABOUT AT A DIFFERENT TIME AND 2265 01:57:20,266 --> 01:57:22,235 I'M HAPPY TO TALK ABOUT IT 2266 01:57:22,301 --> 01:57:22,435 LATER. 2267 01:57:22,502 --> 01:57:26,439 THANK YOU SO MUCH. 2268 01:57:26,506 --> 01:57:29,142 >> I DO THINK SOME WILL BE 2269 01:57:29,208 --> 01:57:32,412 TALKED ABOUT IN SESSION 2 AND I 2270 01:57:32,478 --> 01:57:34,414 DON'T KNOW IF AARON WANTS TO 2271 01:57:34,480 --> 01:57:36,082 TALK TO THE TRANSLATION OF WORK 2272 01:57:36,149 --> 01:57:39,018 BECAUSE I THINK IT'S THE CRUX OF 2273 01:57:39,085 --> 01:57:44,357 THE CONDITIONS SPECIFIC TO 2274 01:57:44,424 --> 01:57:48,594 PREGNANCY AND LACTATION. 2275 01:57:48,661 --> 01:57:50,730 THE CONVERSATION AROUND 2276 01:57:50,797 --> 01:57:53,733 INCLUSION MUCH PREGNANT AND/OR 2277 01:57:53,800 --> 01:57:55,701 LACTATING WOMEN IN CLINICAL 2278 01:57:55,768 --> 01:57:57,336 RESEARCH OR THERAPEUTIC NEEDS 2279 01:57:57,403 --> 01:57:59,038 THAT ARE THERAPEUTIC NEEDS THAT 2280 01:57:59,105 --> 01:58:02,208 RUN IN COMMON AND CONCORDANT 2281 01:58:02,275 --> 01:58:05,011 WITH YOUR PREGNANCY OR LACTATING 2282 01:58:05,077 --> 01:58:08,381 BEING UNDERTAKEN AT THE 2283 01:58:08,448 --> 01:58:09,482 INTERNATIONAL LEVEL. 2284 01:58:09,549 --> 01:58:11,017 AARON DO YOU WANT TO TALK ABOUT 2285 01:58:11,083 --> 01:58:13,453 THE TRANSLATIONAL SPACE TO THE 2286 01:58:13,519 --> 01:58:14,220 CLINICAL TO CARRY THE 2287 01:58:14,287 --> 01:58:24,664 THERAPEUTICS FORWARD. 2288 01:58:29,902 --> 01:58:33,239 THERE'S PROMISING THERAPEUTICS 2289 01:58:33,306 --> 01:58:37,777 AND THERE'S TWO MAJOR INHIBITORY 2290 01:58:37,844 --> 01:58:38,044 THINGS. 2291 01:58:38,110 --> 01:58:39,779 ONE I TALKED ABOUT THE MEDICAL 2292 01:58:39,846 --> 01:58:50,256 LEGAL LIABILITY ISSUES. 2293 01:58:51,290 --> 01:58:54,894 YOU KNOW THE PATIENT POPULATION 2294 01:58:54,961 --> 01:58:57,363 VERSUS THE COVID CONDITION AND 2295 01:58:57,430 --> 01:58:58,231 FOR LACTATION SAFETY WOULD BE IN 2296 01:58:58,297 --> 01:59:08,508 PLACE THERE. 2297 01:59:10,510 --> 01:59:11,677 GETTING THE MODEL TO HAVE A 2298 01:59:11,744 --> 01:59:14,180 BETTER IDEA OF SAFETY AND THE 2299 01:59:14,247 --> 01:59:15,381 OTHER GOES TO CLINICAL TRIAL 2300 01:59:15,448 --> 01:59:20,953 TRIAL DESIGN AND BIOMARKERS. 2301 01:59:21,020 --> 01:59:24,056 YOU HAVE TO GET UP TO ENROLL A 2302 01:59:24,123 --> 01:59:25,625 LARGE NUMBER OF PREGNANT 2303 01:59:25,691 --> 01:59:26,893 INDIVIDUALS AND THAT INCREASES 2304 01:59:26,959 --> 01:59:31,397 THE RISK OF AN ADVERSE EVENT 2305 01:59:31,464 --> 01:59:33,799 RELEVANT TO SAFETY AND EFFICACY 2306 01:59:33,866 --> 01:59:35,067 AND HAVING BIOMARKERS IN PLACE 2307 01:59:35,134 --> 01:59:37,837 FOR RISK STRATIFICATION I THINK 2308 01:59:37,904 --> 01:59:39,305 ARE VERY IMPORTANT FOR 2309 01:59:39,372 --> 01:59:42,141 COMPLETING THAT TRANSLATIONAL 2310 01:59:42,208 --> 01:59:42,408 PIPELINE. 2311 01:59:42,475 --> 01:59:45,411 FOCUSSING A LOT ON ALL ASPECTS 2312 01:59:45,478 --> 01:59:46,212 OF THE REGULATORY SCIENCE 2313 01:59:46,279 --> 01:59:47,713 COMPONENT IS GOING TO BE 2314 01:59:47,780 --> 01:59:50,349 CRITICAL TO MAKING IT EASIER FOR 2315 01:59:50,416 --> 01:59:53,052 NEW THERAPEUTICS TO GO FROM THE 2316 01:59:53,119 --> 02:00:02,161 BENCH TO THE BEDSIDE. 2317 02:00:02,228 --> 02:00:04,564 >> IT'S COMPLEX AND THE 2318 02:00:04,630 --> 02:00:06,365 RECOMMENDATIONS ARE SCATTERED TO 2319 02:00:06,432 --> 02:00:08,367 HOW WE DO THAT AND LOOK 2320 02:00:08,434 --> 02:00:11,804 CAREFULLY TO CONTINUE TO ENSURE 2321 02:00:11,871 --> 02:00:15,841 WE'RE ABLE TO PROGRESS THROUGH 2322 02:00:15,908 --> 02:00:18,244 THE RECOMMENDATIONS AND THEN I 2323 02:00:18,311 --> 02:00:23,149 WANT TO APOLOGIZE, I HAVE TO 2324 02:00:23,215 --> 02:00:25,351 CLOSE OUT SESSION 1 BUT PUT YOUR 2325 02:00:25,418 --> 02:00:26,652 QUESTIONS AND COMMENTS IN THE 2326 02:00:26,719 --> 02:00:28,854 CHAT AND I'LL DO MY BEST TO GET 2327 02:00:28,921 --> 02:00:30,022 THE RIGHT PERSON TO RESPOND 2328 02:00:30,089 --> 02:00:35,528 AND/OR TO MAKE SURE IT'S 2329 02:00:35,595 --> 02:00:39,298 CAPTURED FOR PURPOSES OF 2330 02:00:39,365 --> 02:00:44,370 UPDATING OUR REPORT FOR 2331 02:00:44,437 --> 02:00:44,637 CONGRESS. 2332 02:00:44,704 --> 02:00:48,174 EMMA, TO MAKE SURE WE GET TO THE 2333 02:00:48,240 --> 02:00:49,575 BREAK BUT BEFORE THAT I WANT TO 2334 02:00:49,642 --> 02:00:51,510 THANK OUR COLLEAGUES FROM THE 2335 02:00:51,577 --> 02:00:52,144 NATIONAL INSTITUTES OF CHILD 2336 02:00:52,211 --> 02:00:54,246 HEALTH AND HUMAN DEVELOPMENT. 2337 02:00:54,313 --> 02:00:59,919 IT'S A MONUMENTAL TASK TO WALK 2338 02:00:59,986 --> 02:01:03,356 US THROUGH A FLAVOR OF WHAT'S 2339 02:01:03,422 --> 02:01:06,125 BEEN HAPPENING FOR THE 2340 02:01:06,192 --> 02:01:11,497 RECOMMENDATIONS AND THANK YOU TO 2341 02:01:11,564 --> 02:01:12,965 NAHIDA AND CAMILLE AND AARON. 2342 02:01:13,032 --> 02:01:17,603 >> THANK YOU SO MUCH AND TO MY 2343 02:01:17,670 --> 02:01:17,903 COLLEAGUES. 2344 02:01:17,970 --> 02:01:20,706 WE'LL TAKE A BREAK AND RECONVENE 2345 02:01:20,773 --> 02:01:21,841 AT 2:15 EASTERN. 2346 02:01:21,907 --> 02:01:23,409 WE'LL SEE YOU IN ABOUT 15 2347 02:01:23,476 --> 02:01:23,643 MINUTES. 2348 02:01:23,709 --> 02:01:25,778 THANKS SO MUCH. 2349 02:01:25,845 --> 02:01:28,080 >> I'D LIKE TO WELCOME 2350 02:01:28,147 --> 02:01:42,528 EVERYTHING BACK FOR SESSION 2. 2351 02:01:42,595 --> 02:01:45,264 >> SESSION 2 GOING TO CENTER 2352 02:01:45,331 --> 02:01:46,465 LARGELY ON RECOMMENDATIONS 2353 02:01:46,532 --> 02:01:47,133 RELATED TO POLICY AND REGULATORY 2354 02:01:47,199 --> 02:01:57,343 ISSUES. 2355 02:01:59,779 --> 02:02:02,915 WE LEARNED LEADERSHIP SIGNOFF IS 2356 02:02:02,982 --> 02:02:07,286 STILL PENDING AND THERE ARE SOME 2357 02:02:07,353 --> 02:02:09,321 SUB RECOMMENDATIONS WE ARE NOT 2358 02:02:09,388 --> 02:02:09,889 GOING TO BE ABLE TO DISCUSS 2359 02:02:09,955 --> 02:02:20,066 TODAY. 2360 02:02:21,100 --> 02:02:22,468 WE'LL LOOK TO COVER OUT TIME IN 2361 02:02:22,535 --> 02:02:24,804 OUR IN-PERSON MEETING IN MARCH 2362 02:02:24,870 --> 02:02:25,604 TO DISCUSS MORE. 2363 02:02:25,671 --> 02:02:26,939 IS THERE ANYTHING ELSE YOU'D 2364 02:02:27,006 --> 02:02:27,273 LIKE TO ADD? 2365 02:02:27,339 --> 02:02:31,510 >> THAT COVERS IT. 2366 02:02:31,577 --> 02:02:34,914 >> I ALSO KNOW FROM THE MEETING 2367 02:02:34,980 --> 02:02:35,948 CHAT THERE'S IMPASSIONED 2368 02:02:36,015 --> 02:02:42,388 COMMENTS FOLKS WOULD LIKE TO GET 2369 02:02:42,455 --> 02:02:42,555 TO. 2370 02:02:42,621 --> 02:02:44,190 PLEASE BE PATIENT. 2371 02:02:44,256 --> 02:02:45,791 WITH OUR ABILITY TO TRUNCATE 2372 02:02:45,858 --> 02:02:47,226 SOME DISCUSSIONS WE MAY BE ABLE 2373 02:02:47,293 --> 02:02:53,432 TO CIRCLE BACK AT THE END OF THE 2374 02:02:53,499 --> 02:02:54,433 MEETING. 2375 02:02:54,500 --> 02:03:00,106 I'D LIKE TO WELCOME KEVIN 2376 02:03:00,172 --> 02:03:02,475 PROHASKA AT THE OFFICE OF 2377 02:03:02,541 --> 02:03:06,712 CLINICAL POLICY AT FDA AND 2378 02:03:06,779 --> 02:03:15,221 DR. LYNNE YAO WITHIN THE OFFICE 2379 02:03:15,287 --> 02:03:17,790 OF PEDIATRIC AND MATERNAL 2380 02:03:17,857 --> 02:03:18,023 HEALTH. 2381 02:03:18,090 --> 02:03:20,059 OVER TO KEVIN. 2382 02:03:20,126 --> 02:03:24,363 >> LET ME CLARIFY QUICKLY. 2383 02:03:24,430 --> 02:03:25,831 I'M THE ASSOCIATE DIRECTOR OF 2384 02:03:25,898 --> 02:03:28,134 CLINICAL POLICY IN THE OFFICE OF 2385 02:03:28,200 --> 02:03:30,369 CLINICAL POLICY AND IN THAT ROLE 2386 02:03:30,436 --> 02:03:34,273 I ALSO SERVE AS THE SENIOR BIO 2387 02:03:34,340 --> 02:03:39,678 ETHICIST FOR ADULT BIO RESEARCH. 2388 02:03:39,745 --> 02:03:44,483 MY OFFICE IS THE HUMAN 2389 02:03:44,550 --> 02:03:45,317 PROTECTION REGULATIONS 2390 02:03:45,384 --> 02:03:49,121 SPECIFICALLY HARMONIZING THE 2391 02:03:49,188 --> 02:03:50,289 COMMON RULE AND MY OFFICE HAS 2392 02:03:50,356 --> 02:03:51,857 TAKEN THE LEAD IN DEVELOPING 2393 02:03:51,924 --> 02:03:52,591 THAT. 2394 02:03:52,658 --> 02:03:56,529 SPECIFICALLY, I WAS ASKED TO 2395 02:03:56,595 --> 02:04:00,132 TALK TALK TO FDA'S ACTION 2396 02:04:00,199 --> 02:04:01,667 RECOMMENDED TO THE FDA SHOULD 2397 02:04:01,734 --> 02:04:02,568 HARMONIZE WITH THE COMMON RULE 2398 02:04:02,635 --> 02:04:06,472 IN PREGNANT WOMEN AS A 2399 02:04:06,539 --> 02:04:07,439 VULNERABLE POPULATION. 2400 02:04:07,506 --> 02:04:12,111 FDA HAS ONGOING EFFORT TO 2401 02:04:12,178 --> 02:04:14,446 HARMONIZE RULES SPECIFICALLY 2402 02:04:14,513 --> 02:04:18,450 21CFR50 THE POTENTIAL FOR HUMAN 2403 02:04:18,517 --> 02:04:20,753 SUBJECTS AND THE IRB REGULATIONS 2404 02:04:20,820 --> 02:04:23,989 WITH THE COMMON RULE. 2405 02:04:24,056 --> 02:04:26,458 COLLECTIVELY, 50 AND 56 HAVE 2406 02:04:26,525 --> 02:04:27,459 SUBSTANTIALLY IDENTICAL TO THE 2407 02:04:27,526 --> 02:04:32,598 COMMON RULE WITH A FEW EXCEPTION 2408 02:04:32,665 --> 02:04:38,170 S AND OVER TIME THE DIFFERENCES 2409 02:04:38,237 --> 02:04:41,240 HAVE CHANGED. 2410 02:04:41,307 --> 02:04:43,809 HISTORICALLY THE COMMON RULE ARE 2411 02:04:43,876 --> 02:04:46,745 ALIGN WITH THE INCLUSION OF 2412 02:04:46,812 --> 02:04:48,047 PREGNANT WOMEN AS AN EXAMPLE OF 2413 02:04:48,113 --> 02:04:49,081 A POPULATION THAT MAY BE 2414 02:04:49,148 --> 02:04:52,818 VULNERABLE AND THEY UPDATED THE 2415 02:04:52,885 --> 02:04:55,955 COMMON RULE IN 2018 THE GOOD 2416 02:04:56,021 --> 02:05:02,528 NEWS IN 2022 THEY HARMONIZED 2417 02:05:02,595 --> 02:05:04,630 CERTAIN PROVISIONS OF THE 2418 02:05:04,697 --> 02:05:07,266 REGULATIONS 50, AND 56 TO 2419 02:05:07,333 --> 02:05:08,434 INCLUDE PREGNANT WOMEN AS 2420 02:05:08,500 --> 02:05:09,902 VULNERABLE POPULATION TO 2421 02:05:09,969 --> 02:05:12,304 HARMONIZE WITH THE 2018 COMMON 2422 02:05:12,371 --> 02:05:15,307 RULE TO THE EXTENT PRACTICABLE 2423 02:05:15,374 --> 02:05:19,645 IN CONSISTENT WITH OUR STATUTORY 2424 02:05:19,712 --> 02:05:19,945 PROVISIONS. 2425 02:05:20,012 --> 02:05:21,714 I BELIEVE YOU'VE BEEN PROVIDED A 2426 02:05:21,780 --> 02:05:24,049 LINK TO THE PROPOSED RULES AND 2427 02:05:24,116 --> 02:05:26,418 WILL TRY TO ANSWER QUESTIONS YOU 2428 02:05:26,485 --> 02:05:27,953 HAVE ABOUT IT BUT THE PUBLIC 2429 02:05:28,020 --> 02:05:33,959 COMMENTS FOR THOSE ARE ACTIVELY 2430 02:05:34,026 --> 02:05:37,096 BEING REVIEWED THEY'RE ALSO 2431 02:05:37,162 --> 02:05:37,997 AVAILABLE FOR REVIEW IN THE FDA 2432 02:05:38,063 --> 02:05:39,999 DOCKET AND THE REMOVAL OF 2433 02:05:40,065 --> 02:05:45,304 PREGNANT WOMEN FROM THE LIST HAS 2434 02:05:45,371 --> 02:05:55,314 BEEN GENERALLY FAVORABLE AND 2435 02:05:55,381 --> 02:05:57,316 PREGNANT WOMEN WILL BE REMOVED 2436 02:05:57,383 --> 02:06:07,826 FROM THE LIST WHERE CITED. 2437 02:06:24,109 --> 02:06:25,744 >> WILL THIS GO TO RESEARCH 2438 02:06:25,811 --> 02:06:27,246 DEFINE AND UNDEFINED. 2439 02:06:27,313 --> 02:06:32,518 >> I THINK YOU'RE REFERRING TO A 2440 02:06:32,584 --> 02:06:35,287 REGULATORY REQUIREMENT FOUND IN 2441 02:06:35,354 --> 02:06:38,390 THE SUBPAR B ADDITIONAL PROTECTS 2442 02:06:38,457 --> 02:06:40,592 FOR PREGNANT WOMEN/FETUSES. 2443 02:06:40,659 --> 02:06:42,895 THAT REGULATION, FDA DID NOT 2444 02:06:42,962 --> 02:06:46,565 ADOPT SO MY OFFICE IS NOT 2445 02:06:46,632 --> 02:06:47,967 INVOLVED WITH CHANGING OR 2446 02:06:48,033 --> 02:06:48,934 LOOKING AT THAT. 2447 02:06:49,001 --> 02:06:52,004 >> I FOUND SOMETHING ON THE FDA 2448 02:06:52,071 --> 02:06:53,906 WEBSITE SAYING THOUGH IT DIDN'T 2449 02:06:53,973 --> 02:06:56,108 TOTALLY ADOPT IT IT FOLLOWED IT. 2450 02:06:56,175 --> 02:06:59,979 IS THAT NOT THE CASE? 2451 02:07:00,045 --> 02:07:03,315 >> I BELIEF YOUR REFERRING TO A 2452 02:07:03,382 --> 02:07:09,054 DRAFT GUIDANCE THAT MAKES 2453 02:07:09,121 --> 02:07:15,294 REFERENCES TO SUBPART B THAT IS 2454 02:07:15,361 --> 02:07:18,464 DRAFTED RIGHT NOW AND IS NOT AN 2455 02:07:18,530 --> 02:07:21,300 FDA REGULATION. 2456 02:07:21,367 --> 02:07:23,535 >> UNDERSTOOD. 2457 02:07:23,602 --> 02:07:23,736 OKAY. 2458 02:07:23,802 --> 02:07:26,171 SO FOR THE MOMENT THE DRAFT 2459 02:07:26,238 --> 02:07:27,873 GUIDANCE SAID YOU FOLLOW THE 2460 02:07:27,940 --> 02:07:33,412 SAME POLICY AS THE CFR FOR NIH 2461 02:07:33,479 --> 02:07:41,387 BUT UNDER REREVISION 2018. 2462 02:07:41,453 --> 02:07:47,693 >> I BELIEVE IT'S WRITTEN AS A 2463 02:07:47,760 --> 02:07:50,462 RECOMMENDATION AND GUIDE THAT 2464 02:07:50,529 --> 02:07:54,099 MUST BE FOLLOWED. 2465 02:07:54,166 --> 02:07:56,769 >> IT'S NOT THE ONLY TIME PEOPLE 2466 02:07:56,835 --> 02:07:58,437 HAVE SAID IT'S NOT DRAFT 2467 02:07:58,504 --> 02:07:59,671 GUIDANCE BECAUSE IT DRAGS OUT. 2468 02:07:59,738 --> 02:08:01,407 >> FAIR ENOUGH. 2469 02:08:01,473 --> 02:08:02,541 AS SOON AS IT'S FINALIZED THE 2470 02:08:02,608 --> 02:08:13,152 DRAFT GUIDANCE WILL BE REMOVED. 2471 02:08:15,454 --> 02:08:16,155 >> THANK YOU. 2472 02:08:16,221 --> 02:08:18,357 ANY OTHER CLARIFYING QUESTIONS 2473 02:08:18,424 --> 02:08:21,093 FOR DR. PROHASKA. 2474 02:08:21,160 --> 02:08:22,594 SEEING NONE -- 2475 02:08:22,661 --> 02:08:26,398 >> SORRY. 2476 02:08:26,465 --> 02:08:29,334 I DON'T KNOW IF YOU CAN SAY 2477 02:08:29,401 --> 02:08:31,503 ANYTHING ABOUT THE TIME LINE FOR 2478 02:08:31,570 --> 02:08:33,238 THE RELEASE OF THE FDA 2479 02:08:33,305 --> 02:08:34,473 HARMONIZED REGULATION? 2480 02:08:34,540 --> 02:08:40,846 >> THANK YOU FOR THE QUESTION. 2481 02:08:40,913 --> 02:08:44,650 AS YOU KNOW WE HAVE STRICT 2482 02:08:44,716 --> 02:08:46,418 REQUIREMENTS TO WHAT WE CAN SAY 2483 02:08:46,485 --> 02:08:47,486 SO I DON'T HAVE ENOUGH DATA ON 2484 02:08:47,553 --> 02:08:50,456 THAT. 2485 02:08:50,522 --> 02:08:53,692 >> I UNDERSTAND, THANK YOU. 2486 02:08:53,759 --> 02:08:55,094 >> SEEING NO ADDITIONAL 2487 02:08:55,160 --> 02:09:02,301 QUESTIONS, WE'LL TURN IT OVER TO 2488 02:09:02,367 --> 02:09:03,268 DR. YAO. 2489 02:09:03,335 --> 02:09:04,169 >> I'LL SHARE MY SCREEN AND 2490 02:09:04,236 --> 02:09:14,680 HOPEFULLY THIS WILL WORK. 2491 02:09:15,347 --> 02:09:15,681 ALL RIGHT. 2492 02:09:15,747 --> 02:09:26,291 I'M HOPING -- ARE YOU SEEING MY 2493 02:09:33,465 --> 02:09:34,466 SCREEN? 2494 02:09:34,533 --> 02:09:38,537 >> GOOD. 2495 02:10:01,793 --> 02:10:02,494 >> IT IS. 2496 02:10:02,561 --> 02:10:05,797 >> I'M THRILLED TO BE HERE AND 2497 02:10:05,864 --> 02:10:07,166 VERY MUCH APPRECIATE THE 2498 02:10:07,232 --> 02:10:09,535 OPPORTUNITY TO PRESENT SOME FDA 2499 02:10:09,601 --> 02:10:12,604 UPDATES RELATED TO 2500 02:10:12,671 --> 02:10:13,505 RECOMMENDATION 10 WHICH I 2501 02:10:13,572 --> 02:10:16,575 UNDERSTOOD WAS MY CHARGE FOR 2502 02:10:16,642 --> 02:10:17,109 THIS MEETING. 2503 02:10:17,176 --> 02:10:21,914 SO AS A BACKGROUND I FLOW ALL OF 2504 02:10:21,980 --> 02:10:23,482 YOU ON THE COMMITTEE KNOW THE 2505 02:10:23,549 --> 02:10:26,451 RECOMMENDATIONS BACKWARDS AND 2506 02:10:26,518 --> 02:10:26,985 FORWARDS. 2507 02:10:27,052 --> 02:10:28,086 RECOMMENDATION 10 HAD A LOT OF 2508 02:10:28,153 --> 02:10:28,787 SUB PARTS. 2509 02:10:28,854 --> 02:10:30,756 WHAT THE GIFT AND IMPORTANT PART 2510 02:10:30,822 --> 02:10:32,157 OF RECOMMENDATION 10 WAS TO 2511 02:10:32,224 --> 02:10:33,792 IMPLEMENT A PROACTIVE APPROACH 2512 02:10:33,859 --> 02:10:38,263 TO PROTOCOL DEVELOPMENT AND 2513 02:10:38,330 --> 02:10:39,097 STUDY DESIGN TO INCLUDE PREGNANT 2514 02:10:39,164 --> 02:10:43,535 AND LACTATING WOMEN IN CLINICAL 2515 02:10:43,602 --> 02:10:46,138 RESEARCH. 2516 02:10:46,205 --> 02:10:49,608 IT INCLUDED A LOT OF TEXT UNDER 2517 02:10:49,675 --> 02:10:51,810 EACH RECOMMENDATION BUT EACH OF 2518 02:10:51,877 --> 02:10:54,246 THESE SUB RECOMMENDATIONS THAT 2519 02:10:54,313 --> 02:10:57,849 INVESTIGATIONS AND SPONSORS MUST 2520 02:10:57,916 --> 02:10:59,718 JUSTIFY EXCLUSION AND STUDY 2521 02:10:59,785 --> 02:11:01,486 DESIGN, B, THE STUDIES ARE 2522 02:11:01,553 --> 02:11:05,324 DESIGN TO CAPTURE THE TIME 2523 02:11:05,390 --> 02:11:07,492 DEPENDENCY OF PHYSIOLOGICALLY 2524 02:11:07,559 --> 02:11:09,328 CHANGES IN PREGNANCY AND 2525 02:11:09,394 --> 02:11:11,530 LACTATION WOMEN AND DEVELOPING A 2526 02:11:11,597 --> 02:11:13,732 SYSTEMATIC PLAN HOW TO GET DATA 2527 02:11:13,799 --> 02:11:15,968 IN PREGNANT AND LACTATING WOMEN 2528 02:11:16,034 --> 02:11:23,542 IN A TIMELY PASSION TO INCLUDE 2529 02:11:23,609 --> 02:11:29,181 SAFETY AND THE NOTION OF A 2530 02:11:29,248 --> 02:11:31,416 PRGLAC STUDY PLAN AND DEVELOP 2531 02:11:31,483 --> 02:11:37,022 GUIDANCE FOR IRBs AND 2532 02:11:37,089 --> 02:11:38,156 INVESTIGATORS ABOUT INCLUDING 2533 02:11:38,223 --> 02:11:40,392 PREGNANT AND LACTATING 2534 02:11:40,459 --> 02:11:42,227 INDIVIDUALS IN RESEARCH AND IF 2535 02:11:42,294 --> 02:11:43,895 AN INDIVIDUAL BECOMES PREGNANT 2536 02:11:43,962 --> 02:11:46,465 IN THE STUDY, TO GIVE GUIDANCE 2537 02:11:46,531 --> 02:11:52,571 AND CREATE A PLAN THAT WOULD 2538 02:11:52,638 --> 02:11:57,709 ENCOURAGE PATIENTS TO CONTINUE, 2539 02:11:57,776 --> 02:12:00,379 TO CAPTURE IMPORTANT 2540 02:12:00,445 --> 02:12:02,247 OPPORTUNISTIC INFORMATION IN THE 2541 02:12:02,314 --> 02:12:05,784 PATIENTS WHO DO BECOME PREGNANT 2542 02:12:05,851 --> 02:12:07,953 AND INCLUDE PREGNANCY OUTCOME 2543 02:12:08,020 --> 02:12:08,253 INFORMATION. 2544 02:12:08,320 --> 02:12:10,455 THE REST OF MY TALK WILL BE 2545 02:12:10,522 --> 02:12:21,066 ABOUT WHAT FDA'S DONE AND MOST 2546 02:12:24,002 --> 02:12:27,339 OF HOW FDA COMMUNICATES AND THE 2547 02:12:27,406 --> 02:12:29,541 GUIDANCE ARE FDA'S THINKING 2548 02:12:29,608 --> 02:12:30,475 AND -- 2549 02:12:30,542 --> 02:12:36,848 [NO AUDIO] 2550 02:12:36,915 --> 02:12:42,020 WE'RE WORKING TO REVISE ACTIVELY 2551 02:12:42,087 --> 02:12:43,455 RIGHT NOW. 2552 02:12:43,522 --> 02:12:45,357 SOME GUIDANCES ARE IMPORTANT TO 2553 02:12:45,424 --> 02:12:48,327 POINT OUT BECAUSE THEY ADDRESS 2554 02:12:48,393 --> 02:12:50,162 MANY OF THE RECOMMENDATIONS AND 2555 02:12:50,228 --> 02:12:52,664 SUB RECOMMENDATIONS UNDER 10. 2556 02:12:52,731 --> 02:12:55,901 THE FIRST THIS HAD GOTTEN AT THE 2557 02:12:55,967 --> 02:12:56,968 TIME THE RECOMMENDATIONS WERE 2558 02:12:57,035 --> 02:13:01,506 BEING MADE AND THERE'S A 2559 02:13:01,573 --> 02:13:03,342 REFERENCE TO THIS IN THE ACTUAL 2560 02:13:03,408 --> 02:13:04,643 PRGLAC RECOMMENDATIONS. 2561 02:13:04,710 --> 02:13:11,083 WE DID PUBLISH IN 2018 GUIDANCE 2562 02:13:11,149 --> 02:13:18,123 ON INCLUSION OF PREGNANT WOMEN 2563 02:13:18,190 --> 02:13:19,291 IN CLINICAL TRIALS AND DISCUSSED 2564 02:13:19,358 --> 02:13:20,959 REASONS AND JUSTIFICATIONS FOR 2565 02:13:21,026 --> 02:13:22,027 REASONS FOR PREGNANT INDIVIDUALS 2566 02:13:22,094 --> 02:13:25,297 IN CLINICAL TRIALS. 2567 02:13:25,364 --> 02:13:26,965 THAT ADDRESSES RECOMMENDATION 2568 02:13:27,032 --> 02:13:29,935 10D. 2569 02:13:30,001 --> 02:13:34,940 HOWEVER, IT KIND OF STOPS SHORT 2570 02:13:35,006 --> 02:13:45,317 ABOUT RECOMMENDING THAT DRUG 2571 02:13:45,384 --> 02:13:50,455 DEVELOPERS OR RECOMMENDATION TO 2572 02:13:50,522 --> 02:13:51,957 JUSTIFY COLLUSION. 2573 02:13:52,023 --> 02:13:58,463 THAT WOULD BE 2574 02:13:58,530 --> 02:13:59,264 [AUDIO DIGITIZING] 2575 02:13:59,331 --> 02:14:01,032 DESCRIBES HOW TO COLLECT DATA 2576 02:14:01,099 --> 02:14:02,534 DURING PREGNANCY IF A PATIENT 2577 02:14:02,601 --> 02:14:04,403 WERE TO BECOME PREGNANT AND ALSO 2578 02:14:04,469 --> 02:14:07,072 HOW TO COLLECT PREG NOON SI AS 2579 02:14:07,139 --> 02:14:09,341 PART OF A CLINICAL TRIAL. 2580 02:14:09,408 --> 02:14:15,313 THAT'S BOTH 10B AND 10E AND 2581 02:14:15,380 --> 02:14:17,716 FINALLY A WHOLE SECTION ON 2582 02:14:17,783 --> 02:14:19,084 ISSUES RELATED TO DISCUSSION OF 2583 02:14:19,151 --> 02:14:20,218 WHEN PATIENTS BECOME PREGNANT 2584 02:14:20,285 --> 02:14:21,019 DURING THE TRIAL. 2585 02:14:21,086 --> 02:14:29,327 THE ONE THING IT DOESN'T INCLUDE 2586 02:14:29,394 --> 02:14:30,061 A DISCUSSION FOR RECOMMENDATION 2587 02:14:30,128 --> 02:14:32,664 OF OPPORTUNISTIC DATA BUT TALKS 2588 02:14:32,731 --> 02:14:35,133 ABOUT UB BLINDING AND COLLECTING 2589 02:14:35,200 --> 02:14:35,767 PREGNANCY OUTCOME. 2590 02:14:35,834 --> 02:14:38,470 AND THIS GUIDANCE IS UNDERGOING 2591 02:14:38,537 --> 02:14:45,343 REVIEW AND REVISION. 2592 02:14:45,410 --> 02:14:51,249 >> DR. YAO WE'RE HAVING TROUBLE 2593 02:14:51,316 --> 02:14:54,286 WITH YOU CUTTING IN AND OUT AND 2594 02:14:54,352 --> 02:14:55,720 IF YOU WOULDN'T REMIND REPEATING 2595 02:14:55,787 --> 02:14:56,688 WHERE THE GUIDANCE FALLS SHORT. 2596 02:14:56,755 --> 02:15:07,032 >> MY APOLOGIES. 2597 02:15:09,534 --> 02:15:14,473 LET ME QUICKLY CHECK MY AUDIO. 2598 02:15:14,539 --> 02:15:19,478 I HOPE THAT HELPS. 2599 02:15:19,544 --> 02:15:22,280 THE GUIDANCE FALLS SHORT IN ITEM 2600 02:15:22,347 --> 02:15:26,451 RECOMMENDATION 10A TO 2601 02:15:26,518 --> 02:15:29,488 SPECIFICALLY JUSTIFY EXCLUSION 2602 02:15:29,554 --> 02:15:31,890 THE GUIDANCE TALKS ABOUT THE 2603 02:15:31,957 --> 02:15:34,192 IMPORTANCE OF JUSTIFYING 2604 02:15:34,259 --> 02:15:36,094 INCLUSION BUT REALLY DOESN'T 2605 02:15:36,161 --> 02:15:38,196 CALL OUT A RECOMMENDATION TO 2606 02:15:38,263 --> 02:15:39,531 JUSTIFY EXCLUSION. 2607 02:15:39,598 --> 02:15:40,565 THAT'S 10A. 2608 02:15:40,632 --> 02:15:43,201 THE OTHER PLACE WHERE IT DOESN'T 2609 02:15:43,268 --> 02:15:44,736 COMPLETELY ADDRESS IS ITEM 10E 2610 02:15:44,803 --> 02:15:48,406 WHICH WAS THE IDEA YOU COULD 2611 02:15:48,473 --> 02:15:50,242 COLLECT OPPORTUNISTIC P.K. OR 2612 02:15:50,308 --> 02:15:52,210 CLINICAL DATA IF A PATIENT WERE 2613 02:15:52,277 --> 02:15:53,879 TO BECOME PREGNANT DURING THE 2614 02:15:53,945 --> 02:15:54,246 CLINICAL TRIAL. 2615 02:15:54,312 --> 02:16:00,185 WE DO TALK ABOUT UNBLINDING AND 2616 02:16:00,252 --> 02:16:05,457 TALK ABOUT COLLECTING PATIENT 2617 02:16:05,524 --> 02:16:07,692 OUTCOMES BUT WE'RE NOT TALKING 2618 02:16:07,759 --> 02:16:09,327 ABOUT COLLECTING OPPORTUNISTIC 2619 02:16:09,394 --> 02:16:09,628 INFORMATION. 2620 02:16:09,694 --> 02:16:11,463 I WANTED TO CLARIFY THIS 2621 02:16:11,530 --> 02:16:14,466 PARTICULAR GUIDANCE DOESN'T 2622 02:16:14,533 --> 02:16:22,207 SPEAK TO THOSE TWO ITEMS. 2623 02:16:22,274 --> 02:16:24,442 WAS THAT HELPFUL AND I HOPE 2624 02:16:24,509 --> 02:16:27,112 PEOPLE CAN HEAR ME BETTER NOW? 2625 02:16:27,178 --> 02:16:28,747 >> THAT SEEMS TO BE BETTER. 2626 02:16:28,813 --> 02:16:29,614 >> WONDERFUL. 2627 02:16:29,681 --> 02:16:29,915 MOVING ON. 2628 02:16:29,981 --> 02:16:32,050 THE NEXT GUIDANCE I WANT TO TALK 2629 02:16:32,117 --> 02:16:34,085 ABOUT AND I TAKE YOUR POINT 2630 02:16:34,152 --> 02:16:37,088 HERE, THIS GUIDANCE IS 2631 02:16:37,155 --> 02:16:38,023 ORIGINALLY PUBLISHED IN 2004P.K. 2632 02:16:38,089 --> 02:16:39,691 AND PREGNANCY. 2633 02:16:39,758 --> 02:16:43,495 HOW DO YOU COLLECT P.K. DATA IB 2634 02:16:43,562 --> 02:16:44,930 PREGNANCY. 2635 02:16:44,996 --> 02:16:46,464 WE'RE ACTIVELY UNDER REVIEWING 2636 02:16:46,531 --> 02:16:48,199 THE GUIDANCE AND UNDERGOING 2637 02:16:48,266 --> 02:16:48,667 SUBSTANTIAL REVISION. 2638 02:16:48,733 --> 02:16:56,207 AGAIN AS KEVIN POINTED OUT, 2639 02:16:56,274 --> 02:16:57,842 WE'RE WORKING HARD ON THE 2640 02:16:57,909 --> 02:16:59,044 GUIDANCES. 2641 02:16:59,110 --> 02:17:00,946 THIS GUIDANCE DOES ADDRESS 10B 2642 02:17:01,012 --> 02:17:05,850 AND IT'S ABOUT THE CAPTURING THE 2643 02:17:05,917 --> 02:17:06,952 PHYSIOLOGIC CHANGES DURING 2644 02:17:07,018 --> 02:17:09,287 PREGNANCY AND TRYING TO CAPTURE 2645 02:17:09,354 --> 02:17:12,724 P.K. DATA PREPREGNANCY DURING 2646 02:17:12,791 --> 02:17:15,760 ALL THREE TRIMESTERS AND IN THE 2647 02:17:15,827 --> 02:17:18,463 POSTPARTUM PERIOD AND IT SPEAKS 2648 02:17:18,530 --> 02:17:28,940 TO THAT RECOMMENDATION. 2649 02:17:34,112 --> 02:17:35,347 MANY HAVE HEARD ABOUT THIS 2650 02:17:35,413 --> 02:17:42,454 GUIDANCE AND COMING OUT IN 2019 2651 02:17:42,520 --> 02:17:43,788 AND I'VE BEEN ON THE WORK GROUP 2652 02:17:43,855 --> 02:17:45,490 FOR THIS PARTICULAR GUIDANCE. 2653 02:17:45,557 --> 02:17:52,030 THIS TALKS ABOUT -- CAN YOU 2654 02:17:52,097 --> 02:17:53,098 STILL HEAR ME? 2655 02:17:53,164 --> 02:17:55,367 MY MICROPHONE IS CHANGING ON ME 2656 02:17:55,433 --> 02:17:57,435 AND I DON'T KNOW WHY. 2657 02:17:57,502 --> 02:18:00,405 >> IT DOES SOUND LIKE YOU 2658 02:18:00,472 --> 02:18:02,474 SWITCHED OVER TO A DIFFERENT 2659 02:18:02,540 --> 02:18:03,174 MICROPHONE TO US. 2660 02:18:03,241 --> 02:18:13,585 >> LET ME TRY THIS. 2661 02:18:14,286 --> 02:18:21,326 SO THE NEXT ISSUE RELATES TO 2662 02:18:21,393 --> 02:18:21,993 PHYSIOLOGIC CHANGES AND THIS 2663 02:18:22,060 --> 02:18:23,161 GIVES SPECIFIC RECOMMENDATIONS 2664 02:18:23,228 --> 02:18:25,897 ABOUT THE NEED TO COLLECT 2665 02:18:25,964 --> 02:18:26,464 LACTATION INFORMATION 2666 02:18:26,531 --> 02:18:28,933 POTENTIALLY AT ALL STAGES OF 2667 02:18:29,000 --> 02:18:29,200 LACTATION. 2668 02:18:29,267 --> 02:18:31,569 IT ALSO DESCRIBES SPECIFIC 2669 02:18:31,636 --> 02:18:33,438 SITUATIONS IN WHICH LACTATION IS 2670 02:18:33,505 --> 02:18:38,243 CONSIDERED WHICH I THINK DOES 2671 02:18:38,309 --> 02:18:43,481 SPEAK TO RECOMMENDATION 10D. 2672 02:18:43,548 --> 02:18:48,987 THE NEXT GUIDANCE IS THE POST 2673 02:18:49,054 --> 02:18:50,722 APPROVAL SAFETY GUIDANCE. 2674 02:18:50,789 --> 02:18:56,528 A REALLY IMPORTANT GUIDANCE I 2675 02:18:56,594 --> 02:19:01,166 THINK GIVES US DEVELOPERS A GOOD 2676 02:19:01,232 --> 02:19:02,534 IDEA ABOUT WHAT FDA'S THINKING 2677 02:19:02,600 --> 02:19:06,204 ABOUT AND WHAT TYPES OF 2678 02:19:06,271 --> 02:19:08,273 PREGNANCY STUDIES IN ORDER TO 2679 02:19:08,339 --> 02:19:09,240 COLLECT PREGNANCY SAFETY 2680 02:19:09,307 --> 02:19:10,275 INFORMATION SHOULD BE CONSIDERED 2681 02:19:10,341 --> 02:19:11,509 AND SPECIFICALLY DISCUSSES THE 2682 02:19:11,576 --> 02:19:15,313 TYPES OF STUDIES THAT CAN BE 2683 02:19:15,380 --> 02:19:17,282 CONSIDERED TO COLLECT SAFETY 2684 02:19:17,348 --> 02:19:18,483 INFORMATION IN THE POST 2685 02:19:18,550 --> 02:19:21,619 MARKETING SETTING. 2686 02:19:21,686 --> 02:19:27,325 10C TALKS ABOUT CPK AND THIS 2687 02:19:27,392 --> 02:19:37,936 PARTIALLY ADDRESSES 10C AND THE 2688 02:19:42,574 --> 02:19:46,778 IT FDAs INTEREST IN PDUFA VII TO 2689 02:19:46,845 --> 02:19:48,379 UNDERSTAND SAFETY WHEN DRUGS ARE 2690 02:19:48,446 --> 02:19:49,881 USED DURING PREGNANCY. 2691 02:19:49,948 --> 02:19:55,987 THAT PDUFA FRAMEWORK WILL REALLY 2692 02:19:56,054 --> 02:19:59,290 I HOPE IMPROVE ON GETTING TIMELY 2693 02:19:59,357 --> 02:20:00,625 INFORMATION BACK ON THE SAFETY 2694 02:20:00,692 --> 02:20:02,994 OF THE DRUGS AND BIOLOGICAL 2695 02:20:03,061 --> 02:20:03,962 PROHIBITS OF VACCINES WHEN USED 2696 02:20:04,028 --> 02:20:05,396 DURING PREGNANCY. 2697 02:20:05,463 --> 02:20:08,099 THIS IS JUST A SUMMARY TABLE 2698 02:20:08,166 --> 02:20:09,334 BECAUSE I KNOW IT WAS A LITTLE 2699 02:20:09,400 --> 02:20:11,302 BIT WORDY BUT IF YOU LOOK AT 2700 02:20:11,369 --> 02:20:15,073 EACH OF THE RECOMMENDATIONS, 10A 2701 02:20:15,140 --> 02:20:17,075 THROUGH 10E DO FDA GUIDANCES AND 2702 02:20:17,142 --> 02:20:19,277 FRAMEWORKS BEGUN TO ADDRESS 2703 02:20:19,344 --> 02:20:19,477 THESE? 2704 02:20:19,544 --> 02:20:24,916 YOU CAN SEE IN ALL CASES FOR 10A 2705 02:20:24,983 --> 02:20:27,418 THE GUIDANCES FO SINCE 2018 2706 02:20:27,485 --> 02:20:30,355 ADDRESS THESE RECOMMENDATIONS. 2707 02:20:30,421 --> 02:20:32,524 THE ONE POINT I'LL MAKE IS WE 2708 02:20:32,590 --> 02:20:34,759 TALK ABOUT IN OUR ETHICAL 2709 02:20:34,826 --> 02:20:36,261 CONSIDERATIONS OR SCIENTIFIC AND 2710 02:20:36,327 --> 02:20:37,695 ETHICAL CONSIDERATION FOR 2711 02:20:37,762 --> 02:20:44,035 INCLUSION OF PREGNANT WOMEN IN 2712 02:20:44,102 --> 02:20:47,739 CLINICAL STUDIES THAT IT JUST 2713 02:20:47,806 --> 02:20:49,774 NOT DESCRIBE THE JUSTIFICATION 2714 02:20:49,841 --> 02:20:50,675 FOR EXCLUSION BUT REASONS FOR 2715 02:20:50,742 --> 02:21:00,919 INCLUSION. 2716 02:21:06,424 --> 02:21:07,125 [AUDIO DIGITIZING] 2717 02:21:07,192 --> 02:21:08,893 >> DR. YAO WE HAVE LOST YOU 2718 02:21:08,960 --> 02:21:11,863 AGAIN AS YOU WERE GETTING INTO 2719 02:21:11,930 --> 02:21:16,367 PART 2. 2720 02:21:16,434 --> 02:21:23,274 >> I'M SORRY. 2721 02:21:23,341 --> 02:21:27,178 I CHANGED MY MICROPHONE I HOPE 2722 02:21:27,245 --> 02:21:27,912 THAT HELPS. 2723 02:21:27,979 --> 02:21:30,215 SO IN TERMS OF THE COMMENTS I 2724 02:21:30,281 --> 02:21:34,752 HAVE FOR THE PDUFA VII FRAMEWORK 2725 02:21:34,819 --> 02:21:42,393 FOCUSES ON SAFETY AND 10D WAS TO 2726 02:21:42,460 --> 02:21:43,194 GUIDANCE AND INVESTIGATORS. 2727 02:21:43,261 --> 02:21:48,533 I THINK ALL THE GUIDANCES WE 2728 02:21:48,600 --> 02:21:49,634 PUBLISH IS FOR GUIDANCE FOR 2729 02:21:49,701 --> 02:21:52,203 INDUSTRY AND CAN BE USED FOR IRB 2730 02:21:52,270 --> 02:21:54,472 AND ACADEMIC INVESTIGATORS. 2731 02:21:54,539 --> 02:21:58,576 AND FOR 10E RECOMMENDATIONS 2732 02:21:58,643 --> 02:22:00,345 DON'T CURRENTLY TALK ABOUT 2733 02:22:00,411 --> 02:22:02,480 INCLUSION OF RECOMMENDATIONS FOR 2734 02:22:02,547 --> 02:22:06,451 OPPORTUNITIES TO COLLECTION OF 2735 02:22:06,518 --> 02:22:12,223 SAFETY AND P.A. DATA. 2736 02:22:12,290 --> 02:22:15,994 IN SUMMARY, I DO QUANTITY TO 2737 02:22:16,060 --> 02:22:16,794 POINT OUT THE GAPS. 2738 02:22:16,861 --> 02:22:22,233 THESE GAPS AS I MENTIONED IN 10A 2739 02:22:22,300 --> 02:22:26,170 AND I THOUGHT IT WAS 10C BUT 10A 2740 02:22:26,237 --> 02:22:28,640 TALKS ABOUT THE FDA REQUIRING 2741 02:22:28,706 --> 02:22:31,609 DRUG DEVELOPERS TO PROVIDE A 2742 02:22:31,676 --> 02:22:33,344 PRGLAC STUDY PLAN FOR ASSESSMENT 2743 02:22:33,411 --> 02:22:35,313 DURING DRUG DEVELOPMENT AND 2744 02:22:35,380 --> 02:22:35,914 REPEATED IN 10C. 2745 02:22:35,980 --> 02:22:41,619 THE ONLY THING I WANT TO POINT 2746 02:22:41,686 --> 02:22:45,390 OUT IS CURRENTLY NO EXPLICIT 2747 02:22:45,456 --> 02:22:47,125 STATUTORY OR REGULATORY 2748 02:22:47,191 --> 02:22:48,860 REQUIREMENT THAT SPONSORS MUST 2749 02:22:48,927 --> 02:22:51,195 SUBMIT A PRGLAC STUDY PLAN TO 2750 02:22:51,262 --> 02:22:51,396 FDA. 2751 02:22:51,462 --> 02:22:52,931 THE OTHER POINT I'D LIKE TO MAKE 2752 02:22:52,997 --> 02:22:54,966 AND WOULD LIKE TO HEAR ON THE 2753 02:22:55,033 --> 02:23:00,004 DISCUSSION MOVING FORWARD THIS 2754 02:23:00,071 --> 02:23:02,974 IS ONE AGENCY WITHIN GOVERNMENT. 2755 02:23:03,041 --> 02:23:04,642 I KNOW THE GOAL FOR THE MEETING 2756 02:23:04,709 --> 02:23:06,444 WAS TO TALK ABOUT WHAT 2757 02:23:06,511 --> 02:23:08,012 GOVERNMENTAL AGENCIES HAVE DONE 2758 02:23:08,079 --> 02:23:09,714 TO UPDATE ON THESE 2759 02:23:09,781 --> 02:23:12,850 RECOMMENDATIONS BUT IT BE REALLY 2760 02:23:12,917 --> 02:23:14,452 GREAT TO HEAR IF POSSIBLE WHAT'S 2761 02:23:14,519 --> 02:23:17,488 GOING ON IN ACADEMIA AND 2762 02:23:17,555 --> 02:23:20,024 INDUSTRY AND CERTAINLY IF THERE 2763 02:23:20,091 --> 02:23:21,960 ARE OTHER GOVERNMENTAL AGENCIES 2764 02:23:22,026 --> 02:23:23,361 RECOMMENDATIONS FOR PULLING 2765 02:23:23,428 --> 02:23:26,097 THOSE AGENCIES IN TO HELP A MORE 2766 02:23:26,164 --> 02:23:27,432 FULL UNDERSTANDING OF WHAT'S 2767 02:23:27,498 --> 02:23:28,733 GOING ON IN THE SPACE. 2768 02:23:28,800 --> 02:23:31,169 I THINK THAT WOULD BE SOMETHING 2769 02:23:31,235 --> 02:23:32,203 THE COMMITTEE SHOULD STRONGLY 2770 02:23:32,270 --> 02:23:32,503 CONSIDER. 2771 02:23:32,570 --> 02:23:34,472 AND WITH THAT I WILL STOP 2772 02:23:34,539 --> 02:23:37,075 SHARING AND THANK YOU FOR YOUR 2773 02:23:37,141 --> 02:23:38,376 ATTENTION AND AGAIN MY APOLOGIES 2774 02:23:38,443 --> 02:23:40,712 FOR AUDIO DIFFICULTIES. 2775 02:23:40,778 --> 02:23:44,816 >> THAT WAS A GREAT OVERVIEW, 2776 02:23:44,882 --> 02:23:45,550 LYNNE, THANK YOU. 2777 02:23:45,616 --> 02:23:47,852 BEFORE WE GET IN THE ACTUAL 2778 02:23:47,919 --> 02:23:49,420 DISCUSSION I'LL OPEN FOR ANY 2779 02:23:49,487 --> 02:23:54,459 CLARIFYING QUESTIONS TO DR. YAO 2780 02:23:54,525 --> 02:24:02,066 ABOUT HER PRESENTATION? 2781 02:24:02,133 --> 02:24:02,300 SHARON. 2782 02:24:02,367 --> 02:24:04,202 >> MY QUESTION WAS IS THERE A 2783 02:24:04,268 --> 02:24:05,403 REGULATORY NEED FOR THESE 2784 02:24:05,470 --> 02:24:08,639 STUDIES OR REGULATORY COMMITMENT 2785 02:24:08,706 --> 02:24:10,341 FROM THE PHARMA SIDE. 2786 02:24:10,408 --> 02:24:13,678 THE DATA FOR THEM FOR LACK OF A 2787 02:24:13,745 --> 02:24:14,479 BETTER WORD WILL THEN BECOME 2788 02:24:14,545 --> 02:24:15,980 PART OF THE PACKAGE INSERT? 2789 02:24:16,047 --> 02:24:17,715 WE FIND THE ISSUE ALL THE TIME 2790 02:24:17,782 --> 02:24:19,317 AND THE DRUG IS LICENSED IN 2791 02:24:19,384 --> 02:24:20,651 ADULTS, THERE'S NO DATA IN 2792 02:24:20,718 --> 02:24:21,986 PREGNANCY AND WE'RE DOING THE 2793 02:24:22,053 --> 02:24:24,088 STUDY DURING PREGNANCY AND THE 2794 02:24:24,155 --> 02:24:25,456 QUESTION IS, IS IT A REGULATORY 2795 02:24:25,523 --> 02:24:28,092 OR NOT A REGULATORY STUDY OR 2796 02:24:28,159 --> 02:24:29,494 PHASE 4 AND WHAT'S THE 2797 02:24:29,560 --> 02:24:31,062 REGULATORY COMMITMENT FROM THE 2798 02:24:31,129 --> 02:24:34,632 NETWORK TO DEVELOP THIS STUDY, 2799 02:24:34,699 --> 02:24:41,272 ETMF, THE WHOLE NINE YARDS. 2800 02:24:47,812 --> 02:24:50,615 >> DR. YAO, IF YOU ARE SPEAKING, 2801 02:24:50,681 --> 02:24:57,355 YOU ARE ON MUTE. 2802 02:24:57,422 --> 02:25:04,929 >> WE MAY BE EXPERIENCING SOME 2803 02:25:04,996 --> 02:25:06,297 TECHNICAL DIFFICULTIES, SHARON, 2804 02:25:06,364 --> 02:25:07,031 HOLD ON TO THAT. 2805 02:25:07,098 --> 02:25:13,704 >> FOR ME IT'S THAT BIG 2806 02:25:13,771 --> 02:25:13,971 PICTURE. 2807 02:25:14,038 --> 02:25:16,774 THESE ARE AN FDA REQUIREMENT ARE 2808 02:25:16,841 --> 02:25:19,177 THEY REGULATORY OR PHASE 4 2809 02:25:19,243 --> 02:25:19,477 REQUIREMENT. 2810 02:25:19,544 --> 02:25:21,446 WE NEED TO UNDERSTAND AS PRGLAC 2811 02:25:21,512 --> 02:25:23,081 NETWORK HOW'S DO WE APPROACH 2812 02:25:23,147 --> 02:25:25,083 PHARMA TO DO THESE STUDIES AND 2813 02:25:25,149 --> 02:25:26,317 WHAT'S THE COMMITMENT ON OUR 2814 02:25:26,384 --> 02:25:28,453 SIDE ON THE NETWORK SIDE AND 2815 02:25:28,519 --> 02:25:31,122 WHEN WE WRITE THE STUDIES AND 2816 02:25:31,189 --> 02:25:32,557 WHAT'S THE AUDIT TRAIL TO SUBMIT 2817 02:25:32,623 --> 02:25:33,157 THE DATA. 2818 02:25:33,224 --> 02:25:35,460 IT'S A BIG PICTURE FOR ME AND 2819 02:25:35,526 --> 02:25:36,060 CERTAINLY NOT CLEAR. 2820 02:25:36,127 --> 02:25:38,463 >> I'M GOING SEE IF WE HAVE 2821 02:25:38,529 --> 02:25:40,398 DR. YAO BEFORE WE CONTINUE WITH 2822 02:25:40,465 --> 02:25:50,842 ANY CLARIFYING QUESTIONS. 2823 02:25:50,908 --> 02:25:56,814 IF WE DON'T, ALTA, IF YOU HAVE A 2824 02:25:56,881 --> 02:26:03,387 CLARIFYING QUESTION IN THE CHAT 2825 02:26:03,454 --> 02:26:06,824 HOLD ON UNTIL DR. LYNNE COME 2826 02:26:06,891 --> 02:26:07,058 BACK. 2827 02:26:07,125 --> 02:26:09,360 >> LEYLA ARE YOU ON? 2828 02:26:09,427 --> 02:26:13,564 >> I'M FROM THE DIVISION OF 2829 02:26:13,631 --> 02:26:14,198 PEDIATRICS AND MATERNAL HEALTH. 2830 02:26:14,265 --> 02:26:16,601 THE REQUIREMENTS ARE ISSUED AT 2831 02:26:16,667 --> 02:26:21,339 THE TIME OF NDA OR BLA APPROVAL 2832 02:26:21,405 --> 02:26:22,473 TO INDUSTRY AND THERE ARE 2833 02:26:22,540 --> 02:26:26,277 DEFINITE TIME LINES INCLUDED AS 2834 02:26:26,344 --> 02:26:29,313 PART OF THOSE PMRs AND PUBLICLY 2835 02:26:29,380 --> 02:26:29,780 AVAILABLE INFORMATION. 2836 02:26:29,847 --> 02:26:32,116 WHEN A NEW DRUG IS APPROVED, 2837 02:26:32,183 --> 02:26:34,452 THERE'S AN APPROVAL LETTER AND 2838 02:26:34,519 --> 02:26:40,291 ALONG WITH THAT APPROVAL LETTER 2839 02:26:40,358 --> 02:26:45,229 THERE'S LANGUAGE THAT BASICALLY 2840 02:26:45,296 --> 02:26:51,335 OUTLINES THE PARAMETERS OF THE 2841 02:26:51,402 --> 02:26:53,604 PHASE 4 STUDIES ISSUED WITH THE 2842 02:26:53,671 --> 02:26:54,372 MILESTONE DATES WITH COMPLETION 2843 02:26:54,438 --> 02:26:54,939 OF THE STUDIES. 2844 02:26:55,006 --> 02:26:56,874 I DON'T KNOW IF THAT ANSWERS THE 2845 02:26:56,941 --> 02:26:58,442 QUESTION THAT WAS ASKED. 2846 02:26:58,509 --> 02:27:01,379 >> IT'S HELPFUL BUT I GUESS THE 2847 02:27:01,445 --> 02:27:02,914 REAL QUESTION IS, IS THAT EVERY 2848 02:27:02,980 --> 02:27:06,017 NEW DRUG NOW COMING THROUGH IS 2849 02:27:06,083 --> 02:27:07,585 GOING TO HAVE THIS REQUIREMENT 2850 02:27:07,652 --> 02:27:09,253 OR DO MOST THE COMPANIES GET 2851 02:27:09,320 --> 02:27:11,088 THIS OPT-OUT, WE CAN'T DO IT 2852 02:27:11,155 --> 02:27:12,290 DURING PREGNANCY. 2853 02:27:12,356 --> 02:27:14,158 THERE'S NO OBLIGATION AND THEN 2854 02:27:14,225 --> 02:27:16,527 IT'S INVESTIGATOR INITIATED IF 2855 02:27:16,594 --> 02:27:17,161 IT EVER GOES THROUGH? 2856 02:27:17,228 --> 02:27:22,767 >> THAT'S A GOOD QUESTION. 2857 02:27:22,833 --> 02:27:31,475 I THINK THAT SPEAKS TO A PRGLAC 2858 02:27:31,542 --> 02:27:34,445 RECOMMENDATION FOR THE NEED FOR 2859 02:27:34,512 --> 02:27:35,479 SYSTEMATIC CONSIDERATION OF WHAT 2860 02:27:35,546 --> 02:27:38,449 STUDIES WILL BE NEEDED TO 2861 02:27:38,516 --> 02:27:43,254 ADDRESS THESE DATA GAPS AND THE 2862 02:27:43,321 --> 02:27:44,755 RECOMMENDATION FOR THE NEED FOR 2863 02:27:44,822 --> 02:27:46,457 PREGNANCY AND LACTATION STUDY 2864 02:27:46,524 --> 02:27:50,461 PLANS BECAUSE THE CURRENT 2865 02:27:50,528 --> 02:27:55,833 REGULATORY ENVIRONMENT IS THAT 2866 02:27:55,900 --> 02:27:58,636 THERE ARE REQUIREMENTS IN THE 2867 02:27:58,703 --> 02:27:59,337 SYSTEMATIC WAY. 2868 02:27:59,403 --> 02:28:01,005 THERE'S VARIATION ACROSS REVIEW 2869 02:28:01,072 --> 02:28:03,708 DIVISIONS AND SO THAT IS 2870 02:28:03,774 --> 02:28:05,176 DEFINITELY A DATA GAP. 2871 02:28:05,243 --> 02:28:11,782 THANKS FOR POINTING THAT OUT. 2872 02:28:11,849 --> 02:28:13,651 >> THANK YOU. 2873 02:28:13,718 --> 02:28:15,353 THERE'S A CLARIFICATION 2874 02:28:15,419 --> 02:28:16,387 QUESTION. 2875 02:28:16,454 --> 02:28:18,389 >> NOT SURE IT'S CLARIFYING AND 2876 02:28:18,456 --> 02:28:21,058 DON'T MEAN IT TO BE AGGRESSIVE. 2877 02:28:21,125 --> 02:28:23,461 I SPEAK AS SOMEONE AT THE FDA SO 2878 02:28:23,527 --> 02:28:25,496 I'M FOND OF THE AGENCY. 2879 02:28:25,563 --> 02:28:26,430 WE'RE TALKING ABOUT THE 2880 02:28:26,497 --> 02:28:28,332 INCLUSION OF WOMEN DURING TRIALS 2881 02:28:28,399 --> 02:28:30,468 AND THE SECOND IS IN PHASE IV 2882 02:28:30,534 --> 02:28:32,737 POST APPROVAL POP FOR THE POST 2883 02:28:32,803 --> 02:28:34,372 APPROVAL TO DETERMINE IF IT 2884 02:28:34,438 --> 02:28:36,707 HELPS AT ALL THE QUESTION IS FOR 2885 02:28:36,774 --> 02:28:39,877 ALL POST-APPROVAL PHASE IV 2886 02:28:39,944 --> 02:28:42,380 REQUIREMENTS, WHAT PERCENTAGE OF 2887 02:28:42,446 --> 02:28:44,448 THOSE ARE EVER COMPLETED AND OF 2888 02:28:44,515 --> 02:28:45,349 THOSE HOW MANY ARE COMPLETED ON 2889 02:28:45,416 --> 02:28:47,518 TIME AND FOR THE ONES THAT 2890 02:28:47,585 --> 02:28:49,620 AREN'T, WHAT KIND OF 2891 02:28:49,687 --> 02:28:50,554 DISCIPLINARY MEASURES HAVE EVER 2892 02:28:50,621 --> 02:28:53,991 BEEN TAKEN FOR THE DRUG'S 2893 02:28:54,058 --> 02:28:56,160 APPROVAL FOR BLACK BOX WARNINGS 2894 02:28:56,227 --> 02:28:57,094 OR ANYTHING LIKE THAT? 2895 02:28:57,161 --> 02:28:59,297 I'M TRYING TO FIGURE OUT IF IT'S 2896 02:28:59,363 --> 02:29:00,998 AN EFFECTIVE STRATEGY FOR GET 2897 02:29:01,065 --> 02:29:03,301 THIS INFORMATION OPPOSED TO 2898 02:29:03,367 --> 02:29:06,637 FOCUSSING INSTEAD ON THE 2899 02:29:06,704 --> 02:29:09,774 PRE-APPROVAL MOMENT WHEN THE 2900 02:29:09,840 --> 02:29:11,976 INDUSTRY HAS THE STRONGEST 2901 02:29:12,043 --> 02:29:14,445 INCENTIVE TO GET IT OUT TO THE 2902 02:29:14,512 --> 02:29:18,249 MARKET TO MAKE MONEY. 2903 02:29:18,316 --> 02:29:20,918 >> LYNNE, ARE YOU BACK ON? 2904 02:29:20,985 --> 02:29:23,554 >> I THINK THE WEATHER IS 2905 02:29:23,621 --> 02:29:25,256 PLAYING AND I MOVED LOCATIONS IN 2906 02:29:25,323 --> 02:29:26,991 MY HOME IN ORDER TO HOPEFULLY 2907 02:29:27,058 --> 02:29:30,027 IMPROVE MY SIGNAL. 2908 02:29:30,094 --> 02:29:32,463 LET ME SAY BOTH OF THOSE 2909 02:29:32,530 --> 02:29:34,398 QUESTIONS I THINK WHAT SHARON 2910 02:29:34,465 --> 02:29:36,834 POSES ARE AT THE HEART OF WHAT 2911 02:29:36,901 --> 02:29:37,835 WE'RE STRUGGLING WITH RIGHT NOW. 2912 02:29:37,902 --> 02:29:44,141 WE JUST DID A REVIEW AS PART OF 2913 02:29:44,208 --> 02:29:46,310 THE FRAMEWORK MEETING AND WE 2914 02:29:46,377 --> 02:29:49,080 UNDERTOOK A REVIEW OF SORT OF 2915 02:29:49,146 --> 02:29:50,448 HOW MANY PREGNANCY REGISTRIES 2916 02:29:50,514 --> 02:29:52,516 WERE CONDUCTED AND HOW MANY WERE 2917 02:29:52,583 --> 02:29:58,155 SUCCESSFULLY FULFILLED SORT OF 2918 02:29:58,222 --> 02:30:05,830 BY DIFFERENT THERAPEUTIC AREAS 2919 02:30:05,896 --> 02:30:08,699 AND BY AND LARGE THE REGISTRY 2920 02:30:08,766 --> 02:30:10,267 STUDIES OR THE DATA OR 2921 02:30:10,334 --> 02:30:12,303 POST-MARKETING REQUIREMENT 2922 02:30:12,370 --> 02:30:14,905 STUDIES THAT WERE COMPLETED MOST 2923 02:30:14,972 --> 02:30:16,474 SUCCESSFULLY ALL UTILIZE A 2924 02:30:16,540 --> 02:30:20,277 DISEASE-BASED TYPE OF REGISTRY. 2925 02:30:20,344 --> 02:30:27,184 SO FOR THE ANTI-EPILEPTICS AND 2926 02:30:27,251 --> 02:30:37,161 FOR THE ANTI RETROVIRAL HAD THE 2927 02:30:37,228 --> 02:30:38,796 HIGHEST NUMBER AND I DON'T 2928 02:30:38,863 --> 02:30:39,730 REMEMBER THE DRUGS APPROVED 2929 02:30:39,797 --> 02:30:41,932 COMPARED TO OTHER REGISTRIES OR 2930 02:30:41,999 --> 02:30:44,568 OTHER PMRs WERE REQUIRED AND 2931 02:30:44,635 --> 02:30:45,936 FROM THOSE HOW MANY WERE 2932 02:30:46,003 --> 02:30:46,971 FULFILLED AND HOW MANY HAD 2933 02:30:47,037 --> 02:30:47,238 LABELLING. 2934 02:30:47,304 --> 02:30:48,639 IT'S A FAIR QUESTION. 2935 02:30:48,706 --> 02:30:51,375 WE ANSWERED PART OF THAT WITH 2936 02:30:51,442 --> 02:30:54,445 THE DATA REVIEW WE DID FOR THAT 2937 02:30:54,512 --> 02:30:57,081 MEETING AND WE CAN PROVIDE 2938 02:30:57,148 --> 02:30:58,215 PROBABLY SLIDES FOR THE MEETING 2939 02:30:58,282 --> 02:31:01,152 FOUR AND FOR THE COMMITTEE. 2940 02:31:01,218 --> 02:31:04,722 THE OTHER -- SO I THINK YOU'RE 2941 02:31:04,789 --> 02:31:10,227 RIGHT, THE WHOLE REASON FOR THE 2942 02:31:10,294 --> 02:31:12,997 PDUFA VII FRAMEWORK IS TRY TO 2943 02:31:13,063 --> 02:31:15,166 IMPROVE THE SETTING AND YOU MAKE 2944 02:31:15,232 --> 02:31:17,234 A POINT EVEN IF WE CAN GET DATA 2945 02:31:17,301 --> 02:31:18,903 ARE WE EVER GOING TO GET IT IN A 2946 02:31:18,969 --> 02:31:21,038 TIMELY WAY AND ARE WE GOING TO 2947 02:31:21,105 --> 02:31:26,076 GET INFORMATION THAT SUPPORTS A 2948 02:31:26,143 --> 02:31:33,651 CHANGE TO THE LABEL I LABELLINGE 2949 02:31:33,717 --> 02:31:35,219 NEED TO FOCUS ON PREMARKET. 2950 02:31:35,286 --> 02:31:36,854 I THINK IT'S GOT TO BE A 2951 02:31:36,921 --> 02:31:38,355 COMBINATION OF BOTH. 2952 02:31:38,422 --> 02:31:42,927 I DON'T THINK ULTIMATELY WE'RE 2953 02:31:42,993 --> 02:31:45,729 EVER GOING TO GET ENOUGH 2954 02:31:45,796 --> 02:31:47,264 PREMARKETING AND HAS TO BE A 2955 02:31:47,331 --> 02:31:48,599 COMBINATION OF BOTH AND I THINK 2956 02:31:48,666 --> 02:31:50,434 WE CAN GREATLY IMPROVE WHAT 2957 02:31:50,501 --> 02:31:52,503 WE'RE DOING ON THE 2958 02:31:52,570 --> 02:31:54,438 POST-MARKETING SIDE TO GET MORE 2959 02:31:54,505 --> 02:31:56,106 INFORMATION MORE TIMELY AND GET 2960 02:31:56,173 --> 02:31:59,276 THE SOURCES WE HAVE AND 2961 02:31:59,343 --> 02:32:00,544 COLLECTIVELY COMMIT TO GETTING 2962 02:32:00,611 --> 02:32:02,379 THAT INFORMATION IN A REGISTRY 2963 02:32:02,446 --> 02:32:04,315 WHICH WE KNOW GIVES THE BEST 2964 02:32:04,381 --> 02:32:06,784 INFORMATION WE CAN GET TO WORK 2965 02:32:06,851 --> 02:32:08,052 TOGETHER TO COLLECT THAT 2966 02:32:08,118 --> 02:32:09,553 INFORMATION IN A MORE TIMELY 2967 02:32:09,620 --> 02:32:09,787 FASHION. 2968 02:32:09,854 --> 02:32:12,122 IN MY VIEW IT'S GOT TO BE BOTH. 2969 02:32:12,189 --> 02:32:14,859 WE HAVE TO DO BETTER ON THE 2970 02:32:14,925 --> 02:32:16,293 PRE-MARKET AND ON THE 2971 02:32:16,360 --> 02:32:16,594 POST-MARKET. 2972 02:32:16,660 --> 02:32:18,295 I DON'T THINK IT'S GOING TO BE 2973 02:32:18,362 --> 02:32:20,464 ONE OR THE OTHER. 2974 02:32:20,531 --> 02:32:22,066 TO SHARON, LEYLA ANSWER THE 2975 02:32:22,132 --> 02:32:26,437 QUESTION, I HOPE, THAT YOU WERE 2976 02:32:26,504 --> 02:32:26,670 ASKING. 2977 02:32:26,737 --> 02:32:37,014 I'M STOP THERE. 2978 02:32:49,660 --> 02:32:51,362 >> WE WORKED TO MAKE SURE 2979 02:32:51,428 --> 02:32:53,297 PREGNANT PEOPLE WERE IN THE 2980 02:32:53,364 --> 02:32:54,298 DIVERSITY ACTION PLAN IN THE 2981 02:32:54,365 --> 02:32:57,501 2023 OMNIBUS AND WONDERING IF 2982 02:32:57,568 --> 02:32:59,470 YOU'VE HAD DISCUSSIONS AND 2983 02:32:59,537 --> 02:33:00,671 WONDERING IF THERE'LL BE 2984 02:33:00,738 --> 02:33:02,973 ANYTHING GOOD TO COME OUT OF 2985 02:33:03,040 --> 02:33:04,341 THAT OR SHOULD HAVE TRIED 2986 02:33:04,408 --> 02:33:05,175 ANYTHING OF SOMETHING ELSE AND 2987 02:33:05,242 --> 02:33:06,911 YOUR FEEDBACK AND HOW THAT MIGHT 2988 02:33:06,977 --> 02:33:08,479 HELP US OR NOT IN THE SPACE. 2989 02:33:08,546 --> 02:33:10,681 >> BECKY, THANK YOU AND THANK 2990 02:33:10,748 --> 02:33:15,619 YOU FOR YOUR EFFORTS THROUGH 2991 02:33:15,686 --> 02:33:15,920 SMFM. 2992 02:33:15,986 --> 02:33:21,358 A STRONG ALLIANCE THERE AND 2993 02:33:21,425 --> 02:33:29,166 PUSHING FORWARD FOR THINGS WE 2994 02:33:29,233 --> 02:33:30,434 THINK ARE IMPORTANT AND WHERE WE 2995 02:33:30,501 --> 02:33:32,369 CAN GET THE MENTION OF WHAT TO 2996 02:33:32,436 --> 02:33:34,438 DO WITH PREGNANT INDIVIDUALS 2997 02:33:34,505 --> 02:33:36,907 DESERVE TO BE INCLUDED IN 2998 02:33:36,974 --> 02:33:38,442 RESEARCH AND COLLECT THE 2999 02:33:38,509 --> 02:33:40,578 INFORMATION THAT SUPPORTS THE 3000 02:33:40,644 --> 02:33:43,213 SAFE AND EFFECTIVE USE INCLUDING 3001 02:33:43,280 --> 02:33:43,647 DOSING. 3002 02:33:43,714 --> 02:33:46,083 ANY KINDS OF THOSE EFFORTS I 3003 02:33:46,150 --> 02:33:49,887 THINK IN ANY KIND OF GUIDANCE 3004 02:33:49,954 --> 02:33:51,355 WILL BE HELPFUL TO FDA. 3005 02:33:51,422 --> 02:33:52,389 THAT'S MY PERSONAL OPINION. 3006 02:33:52,456 --> 02:33:59,263 THE OTHER THING I'LL SAY IS THAT 3007 02:33:59,330 --> 02:34:01,465 LET ME BE CLEAR ALL THE GUIDANCE 3008 02:34:01,532 --> 02:34:05,569 I'LL BE MENTIONED ARE NOT FINAL 3009 02:34:05,636 --> 02:34:06,337 YET. 3010 02:34:06,403 --> 02:34:07,471 THERE IS THE OPPORTUNITY TO MAKE 3011 02:34:07,538 --> 02:34:09,206 CHANGES TO GUIDANCES WE HOPE 3012 02:34:09,273 --> 02:34:12,710 WILL BE MORE REFLECTIVE OF THE 3013 02:34:12,776 --> 02:34:15,913 RECOMMENDATIONS OF PRGLAC IF 3014 02:34:15,980 --> 02:34:16,714 THAT'S CODE ENOUGH FOR 3015 02:34:16,780 --> 02:34:17,348 EVERYBODY. 3016 02:34:17,414 --> 02:34:21,485 HOPEFULLY THAT HOPES TO ANSWER. 3017 02:34:21,552 --> 02:34:23,287 >> THANK YOU, CHRISTINA. 3018 02:34:23,354 --> 02:34:25,656 >> THIS IS NOT A QUESTION FOR 3019 02:34:25,723 --> 02:34:29,059 DR. YAO BUT A REMINDER TO THE 3020 02:34:29,126 --> 02:34:31,528 WORKING GROUP, SO ALL THIS 3021 02:34:31,595 --> 02:34:32,329 CONVERSATION IS IMPORTANT 3022 02:34:32,396 --> 02:34:37,735 COUGHINGS BUT IT -- CONVERSATION 3023 02:34:37,801 --> 02:34:40,704 BUT DUPLICATING WHAT HAPPENED IN 3024 02:34:40,771 --> 02:34:41,805 THE ORIGINAL PRGLAC WHICH LED TO 3025 02:34:41,872 --> 02:34:43,140 THE RECOMMENDATIONS. 3026 02:34:43,207 --> 02:34:44,742 WHAT WE'RE SUPPOSED TO FOCUS ON 3027 02:34:44,808 --> 02:34:47,811 IS BASED ON THE RECOMMENDATIONS 3028 02:34:47,878 --> 02:34:49,713 MADE AND SUBRECOMMENDATIONS 3029 02:34:49,780 --> 02:34:50,147 THERE. 3030 02:34:50,214 --> 02:34:52,149 HOW ARE WE PROGRESSING TO DATE 3031 02:34:52,216 --> 02:34:52,883 AND WHAT ADDITIONAL WORK MAY 3032 02:34:52,950 --> 02:34:54,752 NEED TO BE DONE TO BE ABLE TO 3033 02:34:54,818 --> 02:34:56,954 ADVANCE THESE PIECES BECAUSE AS 3034 02:34:57,021 --> 02:35:00,424 YOU SAW WITH WHAT WAS PROVIDED 3035 02:35:00,491 --> 02:35:01,592 FOR THE RECOMMENDATIONS TODAY 3036 02:35:01,659 --> 02:35:04,361 THERE'S A MIX OF PRE-MARKET 3037 02:35:04,428 --> 02:35:06,530 RECOMMENDATIONS AND POST-MARKET 3038 02:35:06,597 --> 02:35:07,564 RECOMMENDATIONS TO GENERATE 3039 02:35:07,631 --> 02:35:09,166 DIFFERENT TYPES OF INFORMATION 3040 02:35:09,233 --> 02:35:10,467 THAT WILL BETTER INFORM 3041 02:35:10,534 --> 02:35:13,303 LABELLING FOR USE IN PREGNANT 3042 02:35:13,370 --> 02:35:14,805 AND LACTATING POPULATIONS. 3043 02:35:14,872 --> 02:35:16,373 THINK ABOUT THAT AS WE'RE 3044 02:35:16,440 --> 02:35:18,509 FURTHER SHAPING THIS DISCUSSION 3045 02:35:18,575 --> 02:35:21,345 ON HOW BEST TO SHAPE A REPORT 3046 02:35:21,412 --> 02:35:21,812 FOR CONGRESS. 3047 02:35:21,879 --> 02:35:28,552 >> THANK YOU, CHRISTINA. 3048 02:35:28,619 --> 02:35:30,721 RACHEL, HOLD YOUR QUESTION AND 3049 02:35:30,788 --> 02:35:33,257 I'LL ASK EMMA TO PULL UP OUR 3050 02:35:33,323 --> 02:35:34,224 SLIDES FOR DISCUSSION TODAY SO 3051 02:35:34,291 --> 02:35:38,629 WE HAVE THAT FRAMEWORK SET UP. 3052 02:35:38,696 --> 02:35:39,563 WE KNOW WHY WE WANT THE 3053 02:35:39,630 --> 02:35:42,466 DIRECTION OF THE CONVERSATION TO 3054 02:35:42,533 --> 02:35:52,609 GO. 3055 02:35:56,213 --> 02:35:57,381 AGAIN, RECOMMENDATION 1A 3056 02:35:57,448 --> 02:35:58,315 INCLUDES DISCUSSING AND 3057 02:35:58,382 --> 02:35:59,850 INTEGRATING PREGNANT AND 3058 02:35:59,917 --> 02:36:05,422 LACTATING WOMEN IN THE RESEARCH 3059 02:36:05,489 --> 02:36:05,656 AGENDA. 3060 02:36:05,723 --> 02:36:10,961 WE 1A WAS ACCOMPLISHED. 3061 02:36:11,028 --> 02:36:15,232 IN 2019 THE COMMON RULE WAS 3062 02:36:15,299 --> 02:36:17,101 UPDATED AND THIS COULD BE 3063 02:36:17,167 --> 02:36:19,203 CONSIDERED COMPLETE AND WHAT 3064 02:36:19,269 --> 02:36:20,170 WE'LL DISCUSS AROUND 3065 02:36:20,237 --> 02:36:30,647 RECOMMENDATION 1 IS 1B. 3066 02:36:34,251 --> 02:36:35,319 HERE WE'RE TALKING ABOUT 3067 02:36:35,385 --> 02:36:36,520 RECOMMENDATIONS THAT HAVE TO DO 3068 02:36:36,587 --> 02:36:38,489 WITH ARE REMOVING REGULATORY 3069 02:36:38,555 --> 02:36:39,823 BARRIERS TO RESEARCH. 3070 02:36:39,890 --> 02:36:42,459 AND BECAUSE WE ARE WAITING ON 3071 02:36:42,526 --> 02:36:45,629 THE WRITTEN FROM UPDATE FROM 3072 02:36:45,696 --> 02:36:46,497 OHRP WE WILL NOT BE DISCUSSING 3073 02:36:46,563 --> 02:36:50,334 THIS RECOMMENDATION TODAY. 3074 02:36:50,400 --> 02:36:58,342 AGAIN, AS WITH RECOMMENDATION 4, 3075 02:36:58,408 --> 02:36:59,376 BECAUSE WE FEEL ADDITIONAL 3076 02:36:59,443 --> 02:37:01,178 ACTION NEEDS TO BE MOVED FORWARD 3077 02:37:01,245 --> 02:37:04,114 NEITHER WILL BE DISCUSSED TODAY 3078 02:37:04,181 --> 02:37:05,916 BUT ANY COMMENTS YOU HAVE CAN BE 3079 02:37:05,983 --> 02:37:12,723 PROVIDED WHEN WE SEND OUT THE 3080 02:37:12,790 --> 02:37:13,056 PO 3081 02:37:13,123 --> 02:37:14,458 POST-MEETING SUMMARY AND THE 3082 02:37:14,525 --> 02:37:16,460 LAST SLIDE IS WHERE WE'LL SPEND 3083 02:37:16,527 --> 02:37:18,495 OUR TIME TODAY AS IT RELATES TO 3084 02:37:18,562 --> 02:37:20,998 RECOMMENDATION 10. 3085 02:37:21,064 --> 02:37:21,865 THIS SPECIFICALLY IMPLEMENTATION 3086 02:37:21,932 --> 02:37:25,836 OF A PROACTIVE APPROACH TO STUDY 3087 02:37:25,903 --> 02:37:27,571 DESIGN AS CAN BE READ OFF THE 3088 02:37:27,638 --> 02:37:28,238 SLIDE AS WELL. 3089 02:37:28,305 --> 02:37:36,246 SO I'M GOING TO TAKE US BACK TO 3090 02:37:36,313 --> 02:37:38,015 RECOMMENDATION 1 AND SEE IF WE 3091 02:37:38,081 --> 02:37:43,086 CAN'T GET THE CONVERSATION GOING 3092 02:37:43,153 --> 02:37:46,824 ABOUT VIEWS ON PROGRESS AND 3093 02:37:46,890 --> 02:37:47,658 ADDITIONAL ACTION THAT NEEDS TO 3094 02:37:47,724 --> 02:37:58,202 BE CALLED OUT IN OUR RECORD. 3095 02:38:22,259 --> 02:38:29,166 THE IMPACT OF 1A AND MOVING 3096 02:38:29,233 --> 02:38:39,710 TOWARDS 1B AND A CHANGE OF 3097 02:38:48,085 --> 02:38:49,219 TRIALS IN RESEARCH POPULATIONS 3098 02:38:49,286 --> 02:38:51,054 AND IF YOU'RE SEEING DIFFERENT 3099 02:38:51,121 --> 02:38:54,458 APPROACH TO IRBs OR IF IN OUR 3100 02:38:54,524 --> 02:38:58,595 REPORT WE NEED TO RECOMMEND 3101 02:38:58,662 --> 02:39:01,965 ADDITIONAL ACTIONS TO GET US TO 3102 02:39:02,032 --> 02:39:04,868 WHERE WE NEED TO GO AND THE 3103 02:39:04,935 --> 02:39:07,304 INTENT WAS OF THE ORIGINAL TASK 3104 02:39:07,371 --> 02:39:08,572 FORCE BY MOVING THE POPULATION 3105 02:39:08,639 --> 02:39:11,074 THIS WOULD MOVE US DOWN THE PATH 3106 02:39:11,141 --> 02:39:18,482 OF SEEING MORE OF THIS RESEARCH 3107 02:39:18,548 --> 02:39:20,484 BEING STARTING IN THE FIRST 3108 02:39:20,550 --> 02:39:20,684 PLACE. 3109 02:39:20,751 --> 02:39:22,819 >> RICHEL, THIS IS ALISON, THANK 3110 02:39:22,886 --> 02:39:33,430 YOU VERY MUCH FOR THE QUESTION. 3111 02:39:43,874 --> 02:39:49,112 INDs THAT INCLUDE TRIALS IN 3112 02:39:49,179 --> 02:39:59,456 PREGNANT WOMEN 3113 02:40:11,001 --> 02:40:14,438 >> THERE'S A FAIR BIT OF OVERLAP 3114 02:40:14,504 --> 02:40:16,573 BEYOND EXTENDING BEYOND WITH 3115 02:40:16,640 --> 02:40:19,476 RESPECT TO 1A AND 1B AND IF WE 3116 02:40:19,543 --> 02:40:21,078 HAVE SUMMARY COMMENTS FROM FDA 3117 02:40:21,144 --> 02:40:22,112 I'D WELCOME THEM. 3118 02:40:22,179 --> 02:40:24,247 >> THIS IS KEVIN. 3119 02:40:24,314 --> 02:40:26,083 I'LL TRY TO RESPOND THOUGH I 3120 02:40:26,149 --> 02:40:27,317 DON'T HAVE THE DATA. 3121 02:40:27,384 --> 02:40:34,191 ACTUALLY, I'M NOT AWARE OF ANY 3122 02:40:34,257 --> 02:40:36,526 DATA THAT WILL SAY WHETHER THIS 3123 02:40:36,593 --> 02:40:38,195 RESEARCH WILL BE MORE 3124 02:40:38,261 --> 02:40:40,063 FORTHCOMING IN THIS SPACE AND 3125 02:40:40,130 --> 02:40:42,466 HOPE IT WILL BE. 3126 02:40:42,532 --> 02:40:45,235 I HEARD ANECDOTALLY FROM IRB 3127 02:40:45,302 --> 02:40:46,570 MEMBERS IT WILL HAVE AN IMPACT 3128 02:40:46,636 --> 02:40:52,142 ON THEIR DELIBERATIONS AND AS 3129 02:40:52,209 --> 02:40:56,546 SUCH MOVING PREGNANT WOMEN AS A 3130 02:40:56,613 --> 02:40:57,514 VULNERABLE POPULATION WILL ALLOW 3131 02:40:57,581 --> 02:40:59,282 MORE RESEARCH GOING FORWARD. 3132 02:40:59,349 --> 02:41:01,518 WHETHER THAT'S TRANSLATED TO 3133 02:41:01,585 --> 02:41:03,086 MORE PROTOCOLS BE SUBMITTED TO 3134 02:41:03,153 --> 02:41:04,287 THE FDA IN THE SPACE I'M AFRAID 3135 02:41:04,354 --> 02:41:06,757 I DON'T HAVE AN ANSWER TO THAT 3136 02:41:06,823 --> 02:41:17,000 QUESTION. 3137 02:41:37,721 --> 02:41:39,956 >> ACROSS THE IMPLEMENTATION 3138 02:41:40,023 --> 02:41:41,425 WORKING PLANS SPECIFIC COMMENTS 3139 02:41:41,491 --> 02:41:42,492 OF NOT ONLY INCLUDING PREGNANT 3140 02:41:42,559 --> 02:41:44,961 AND LACTATING INDIVIDUALS IN THE 3141 02:41:45,028 --> 02:41:47,030 INCLUSION OF RESEARCH BUT ALSO 3142 02:41:47,097 --> 02:41:48,465 INCLUDING THEM INTO THE 3143 02:41:48,532 --> 02:41:50,634 DISCUSSION OF HOW RESEARCH IS 3144 02:41:50,700 --> 02:41:51,735 DESIGN OR CONDUCTED. 3145 02:41:51,802 --> 02:41:54,471 AND SPECIFICALLY THINKING OF 3146 02:41:54,538 --> 02:41:57,040 COMMUNITY ADVISORY BOARDS OR 3147 02:41:57,107 --> 02:42:00,010 ADVOCACY GROUPS AND I WASN'T 3148 02:42:00,077 --> 02:42:01,211 SURE IF THAT FITS INTO 3149 02:42:01,278 --> 02:42:03,413 RECOMMENDATION 1 OR FOUND IN 3150 02:42:03,480 --> 02:42:06,750 OTHER PLACES BUT SEEMED 3151 02:42:06,817 --> 02:42:08,251 WORTHWHILE FOR US RAISING 3152 02:42:08,318 --> 02:42:08,952 BROADLY. 3153 02:42:09,019 --> 02:42:10,620 I FEEL IT'S WORTH ALLUDING TO AT 3154 02:42:10,687 --> 02:42:12,089 TIMES BUT WE SHOULD HAVE EFFORTS 3155 02:42:12,155 --> 02:42:14,524 TO ENCOURAGE THAT AND AT TIMES 3156 02:42:14,591 --> 02:42:16,560 IT'S BEEN ALLUDED TO I'M NOT 3157 02:42:16,626 --> 02:42:18,495 SURE ABOUT PROGRESS MADE IN THAT 3158 02:42:18,562 --> 02:42:18,695 RENA. 3159 02:42:18,762 --> 02:42:18,962 THANK YOU. 3160 02:42:19,029 --> 02:42:20,964 -- THAT ARENA. 3161 02:42:21,031 --> 02:42:26,470 >> THIS IS ALISON AND I WANT TO 3162 02:42:26,536 --> 02:42:34,077 EC ECHO WHAT A FANTASTIC POINT 3163 02:42:34,144 --> 02:42:36,847 AND QUESTION THAT IS FROM YOU 3164 02:42:36,913 --> 02:42:42,486 AND WHAT IS GOING PART AT 3165 02:42:42,552 --> 02:42:53,096 COMANCHE WHERE I'M THE HERE AT 3166 02:43:03,240 --> 02:43:06,476 THE STUDY AND WE HAVE A 3167 02:43:06,543 --> 02:43:07,944 RESPONSIBILITY AND THAT'S PART 3168 02:43:08,011 --> 02:43:10,480 IS TO INCLUDE THE VOICE OF THE 3169 02:43:10,547 --> 02:43:18,488 PATIENT ADVOCATES FROM THE VERY 3170 02:43:18,555 --> 02:43:28,165 BEGINNING OPPOSED TO GOING FROM 3171 02:43:28,231 --> 02:43:32,402 LICENSURE AND GOING FROM THE 3172 02:43:32,469 --> 02:43:42,746 PROTOCOL ITSELF. 3173 02:43:48,185 --> 02:43:49,653 >> IF THERE'S ADDITIONAL 3174 02:43:49,719 --> 02:43:51,288 THOUGHTS BEFORE WE MOVE TO 3175 02:43:51,354 --> 02:43:52,255 RECOMMENDATION 10 WHERE IS WHERE 3176 02:43:52,322 --> 02:43:54,491 THE BULK OF OUR CONVERSATION 3177 02:43:54,558 --> 02:44:04,701 WILL BE. 3178 02:44:17,280 --> 02:44:18,548 WE'VE GOT FIVE SUB 3179 02:44:18,615 --> 02:44:19,749 RECOMMENDATIONS AND THERE'S A 3180 02:44:19,816 --> 02:44:20,884 NUMBER BENEATH THERE BUT I'LL 3181 02:44:20,951 --> 02:44:25,088 START BY OPENING IT UP TO 3182 02:44:25,155 --> 02:44:26,489 COMMENTS, ADDITIONAL QUESTIONS 3183 02:44:26,556 --> 02:44:30,460 THAT WE HAVE AROUND THESE SUB 3184 02:44:30,527 --> 02:44:31,061 RECOMMENDATIONS OR POINTS OF 3185 02:44:31,127 --> 02:44:41,338 DISCUSSION. 3186 02:45:20,644 --> 02:45:23,113 >> THERE'S A QUESTION OF HOW ARE 3187 02:45:23,179 --> 02:45:26,716 WE DEALING WITH THESE ELEMENTS? 3188 02:45:26,783 --> 02:45:30,287 I CAN SAY THAT WE ESTABLISHED 3189 02:45:30,353 --> 02:45:34,624 THIS BUT HAS THAT MOVED THE 3190 02:45:34,691 --> 02:45:36,559 NEEDLE AT ALL AND THE COMMENT IN 3191 02:45:36,626 --> 02:45:38,962 THE CHAT MAY BE SOMETHING WE 3192 02:45:39,029 --> 02:45:43,700 SHOULD CONSIDER WHICH IS TO SEE 3193 02:45:43,767 --> 02:45:46,236 SINCE THE PRGLAC RECOMMENDATIONS 3194 02:45:46,303 --> 02:45:47,904 HAVE BEEN ISSUED HOW MANY 3195 02:45:47,971 --> 02:45:52,842 PREGNANT INDIVIDUALS HAVE BEEN 3196 02:45:52,909 --> 02:46:01,751 ENROLLED IN CLINICAL TRIALS. 3197 02:46:01,818 --> 02:46:03,386 THOSE ARE THE KINDS OF THINGS 3198 02:46:03,453 --> 02:46:09,359 THAT MAY BE USEFUL TO DO AS A 3199 02:46:09,426 --> 02:46:11,328 RECOMMENDATION TO MAYBE ASSESS 3200 02:46:11,394 --> 02:46:16,866 IN SOME WAY GUIDANCE BEING 3201 02:46:16,933 --> 02:46:22,472 ISSUED FOR EXAMPLE AND IT'S 3202 02:46:22,539 --> 02:46:24,974 BASED ON CHRISTINA'S COMMENT. 3203 02:46:25,041 --> 02:46:27,544 >> AGAIN WE'RE HEARING SEVERAL 3204 02:46:27,610 --> 02:46:28,878 COMMENTS NOW ABOUT MOVING BEYOND 3205 02:46:28,945 --> 02:46:30,880 PROGRESS AND LOOKING AT IMPACT 3206 02:46:30,947 --> 02:46:32,882 OR UNDERSTANDING IMPACT AND 3207 02:46:32,949 --> 02:46:34,484 MAKING SURE THAT WE EMPHASIZE 3208 02:46:34,551 --> 02:46:37,120 THE IMPORTANCE OF GOING BEYOND 3209 02:46:37,187 --> 02:46:42,125 JUST NOTICING WHERE THE PROGRESS 3210 02:46:42,192 --> 02:46:47,931 IS. 3211 02:46:47,997 --> 02:46:50,467 IT SOUNDS LIKE THERE MAY BE 3212 02:46:50,533 --> 02:46:53,970 LITERATURE WHETHER THE NEEDLE 3213 02:46:54,037 --> 02:46:55,105 WOULD MOVE WITH THE COMMON RULE 3214 02:46:55,171 --> 02:46:56,506 IN TERM OF WHAT WE KNOW BUT 3215 02:46:56,573 --> 02:46:58,775 FINDING OUT WOULD BE HELPFUL. 3216 02:46:58,842 --> 02:47:00,577 I JUST WANT TO EMPHASIZE WE'VE 3217 02:47:00,643 --> 02:47:01,478 BEEN CIRCLING AROUND THIS AND WE 3218 02:47:01,544 --> 02:47:05,548 TALKED ABOUT IT BUT I THINK THE 3219 02:47:05,615 --> 02:47:08,218 IMPORTANCE OF 10A HAS NOT BEEN 3220 02:47:08,284 --> 02:47:09,886 SUFFICIENTLY ADDRESSED AND IF 3221 02:47:09,953 --> 02:47:11,388 THERE ARE OPPORTUNITIES NOW AS 3222 02:47:11,454 --> 02:47:13,022 WE HEARD BECAUSE SO MUCH OF THE 3223 02:47:13,089 --> 02:47:16,092 GUIDANCE FROM FDA IS IN DRAFT 3224 02:47:16,159 --> 02:47:19,629 FORM TO TRY TO GET THIS PIECE OF 3225 02:47:19,696 --> 02:47:20,964 REQUIRING JUSTIFICATION OF 3226 02:47:21,030 --> 02:47:25,969 EXCLUSION INCLUDED IN GOODANCE 3227 02:47:26,035 --> 02:47:28,772 WHICH FROM FDA HAS PRACTICAL 3228 02:47:28,838 --> 02:47:31,708 GUIDANCE AND GUIDANCE FROM THE 3229 02:47:31,775 --> 02:47:33,943 FDA IS SEEN IS TAKEN QUITE 3230 02:47:34,010 --> 02:47:35,311 SERIOUSLY FROM INDUSTRY. 3231 02:47:35,378 --> 02:47:38,047 IF WE CAN GET THIS PIECE IN 3232 02:47:38,114 --> 02:47:41,084 THERE NOW GIVEN THE STAGE OF 3233 02:47:41,151 --> 02:47:44,120 WHERE DRAFT GUIDANCE IS WE 3234 02:47:44,187 --> 02:47:45,321 SHOULD INCLUDE THAT IN THE 3235 02:47:45,388 --> 02:47:45,755 REPORT. 3236 02:47:45,822 --> 02:47:50,960 AND I'M SPEAKING MOSTLY FROM 3237 02:47:51,027 --> 02:47:54,164 KNOWING THE IRB WORLD IT'S SO 3238 02:47:54,230 --> 02:47:57,767 ENGRAINED CULTURALLY THE 3239 02:47:57,834 --> 02:48:00,837 ASSUMPTION IS WE DON'T DO THAT. 3240 02:48:00,904 --> 02:48:03,339 THERE'S AN ACCEPTANCE THAT ONE 3241 02:48:03,406 --> 02:48:08,445 WOULDN'T INCLUDE PREGNANT WOMEN 3242 02:48:08,511 --> 02:48:12,148 IN MOST RESEARCH. 3243 02:48:12,215 --> 02:48:13,616 I'M TALKING ABOUT INVESTIGATION 3244 02:48:13,683 --> 02:48:15,084 PREGNANT AND NON-PREGNANT PEOPLE 3245 02:48:15,151 --> 02:48:15,952 AS PART OF THE RESEARCH. 3246 02:48:16,019 --> 02:48:17,887 WE DON'T TOUCH THAT. 3247 02:48:17,954 --> 02:48:19,856 IT'S A REAL CULTURE SHIFT TO 3248 02:48:19,923 --> 02:48:22,425 TELL US THE STORY WHY YOU'RE 3249 02:48:22,492 --> 02:48:24,093 INCLUDING PREGNANT OR LACTATING 3250 02:48:24,160 --> 02:48:24,294 WOMEN. 3251 02:48:24,360 --> 02:48:26,996 TO THE EXTENT WE CAN FOCUS ON 3252 02:48:27,063 --> 02:48:29,432 10A THERE NEEDS TO BE MORE WORK 3253 02:48:29,499 --> 02:48:30,467 TO MOVE THE NEEDLE, THAT'S 3254 02:48:30,533 --> 02:48:39,175 IMPORTANT. 3255 02:48:39,242 --> 02:48:40,643 >> THERE'S WORK DONE BY 3256 02:48:40,710 --> 02:48:42,479 INVESTIGATORS AND SPONSORS AND 3257 02:48:42,545 --> 02:48:44,714 THEIR LOCAL HUMAN ETHICS 3258 02:48:44,781 --> 02:48:45,248 AUTHORITY BODIES AS WELL. 3259 02:48:45,315 --> 02:48:52,856 THANK YOU. 3260 02:48:52,922 --> 02:48:57,160 >> I WANT TO APOLOGIZE FIRST IF 3261 02:48:57,227 --> 02:48:58,461 THIS WAS COVERED IN THE 3262 02:48:58,528 --> 02:49:00,997 BEGINNING I WAS DISTRACT WORKMEN 3263 02:49:01,064 --> 02:49:03,466 IN MY APARTMENT, TO EXTENT 3264 02:49:03,533 --> 02:49:05,869 THERE'S BEEN GUIDANCE DEVELOPED 3265 02:49:05,935 --> 02:49:10,039 AND CONVERSATIONS, HAS IT 3266 02:49:10,106 --> 02:49:11,641 ADDRESSED THE ROLE OF THE 3267 02:49:11,708 --> 02:49:14,377 MARITAL OR NON-MARITAL PARTNER 3268 02:49:14,444 --> 02:49:17,280 INTENDED CO-REARING PARTNER THE 3269 02:49:17,347 --> 02:49:19,749 DEFINITION OF WHOM IS AT ISSUE 3270 02:49:19,816 --> 02:49:22,452 IS SOMETIMES NOT BEEN ADDRESSED. 3271 02:49:22,519 --> 02:49:23,820 IN OTHER SETTINGS I'VE SEEN 3272 02:49:23,887 --> 02:49:26,456 EXAMPLES WHERE THE WORLD OF THE 3273 02:49:26,523 --> 02:49:29,092 SECOND ADULT BOTH IN TERMS OF 3274 02:49:29,158 --> 02:49:30,326 GIVING CONSENT UNDER SOME 3275 02:49:30,393 --> 02:49:31,261 LIMITED CIRCUMSTANCES AND EVEN 3276 02:49:31,327 --> 02:49:33,796 IN JUST KNOWING A WOMAN IS 3277 02:49:33,863 --> 02:49:34,998 ENROLLING IN RESEARCH BECOMES 3278 02:49:35,064 --> 02:49:36,633 RELEVANT TO WHETHER OR NOT YOU 3279 02:49:36,699 --> 02:49:38,468 CAN GET HER IN AND NOT SURE IF 3280 02:49:38,535 --> 02:49:40,069 THE GUIDANCES ARE BEING 3281 02:49:40,136 --> 02:49:42,472 DEVELOPED WITH THAT KIND OF 3282 02:49:42,539 --> 02:49:44,173 ISSUE IN MIND. 3283 02:49:44,240 --> 02:49:45,408 >> LYNN OR KEVIN DO YOU WANT TO 3284 02:49:45,475 --> 02:49:55,084 ADDRESS THAT? 3285 02:49:55,151 --> 02:49:59,822 >> RECENTLY WE PUBLISHED AN 3286 02:49:59,889 --> 02:50:02,091 UPDATED GUIDANCE ON INFORMED 3287 02:50:02,158 --> 02:50:03,359 CONSENT I BELIEVE IN SEPTEMBER 3288 02:50:03,426 --> 02:50:04,294 OF 2023. 3289 02:50:04,360 --> 02:50:09,265 IT DOES NOT TOUCH ON THE ISSUE 3290 02:50:09,332 --> 02:50:12,669 OF THE PARENT BEING INVOLVED IN 3291 02:50:12,735 --> 02:50:12,902 CONSENT. 3292 02:50:12,969 --> 02:50:17,740 CURRENTLY OUR REGULATIONS 3293 02:50:17,807 --> 02:50:21,110 REQUIRE THE WOMAN TO GIVE 3294 02:50:21,177 --> 02:50:21,344 CONSENT. 3295 02:50:21,411 --> 02:50:23,346 HOWEVER, AT TIMES DURING OUR 3296 02:50:23,413 --> 02:50:28,918 REVIEW OF SUCH PROTOCOLS WHEN 3297 02:50:28,985 --> 02:50:39,495 THERE'S UNUSUAL RISK FOR THEY 3298 02:50:49,339 --> 02:50:49,872 WILL TO BE INVOLVED. 3299 02:50:49,939 --> 02:50:53,242 >> FOR FEAR OF FAMILY MEMBERS OR 3300 02:50:53,309 --> 02:50:54,577 HUSBANDS KNOWING FOR EXAMPLE 3301 02:50:54,644 --> 02:50:57,080 SOMEONE IS HIV POSITIVE WOMEN 3302 02:50:57,146 --> 02:50:59,549 WOULDN'T ENROLL IN TRIALS TO 3303 02:50:59,616 --> 02:51:01,484 THEIR BENEFIT OR THE BENEFIT OF 3304 02:51:01,551 --> 02:51:03,353 THEIR FUTURE CHILDS. 3305 02:51:03,419 --> 02:51:05,655 THE PROTOCOLS HAD TO BE ADAPTED 3306 02:51:05,722 --> 02:51:09,859 SO IT CAN LIE OR COME UP WITH 3307 02:51:09,926 --> 02:51:11,961 NEW DELIVERY SYSTEMS WITH 3308 02:51:12,028 --> 02:51:14,263 INJECTIONS THAT LOOK LIKE 3309 02:51:14,330 --> 02:51:18,201 VITAMINS OR SOMETHING ELSE. 3310 02:51:18,267 --> 02:51:23,006 THINK HOW THE FAMILY SITUATIONS 3311 02:51:23,072 --> 02:51:24,574 ARE INVOLVED IN ENROLLMENT. 3312 02:51:24,641 --> 02:51:30,079 >> WE CAME UP WITH THE SAME IN 3313 02:51:30,146 --> 02:51:33,416 THE EBOLA CRISIS AND THINKING 3314 02:51:33,483 --> 02:51:39,088 CREATIVELY. 3315 02:51:39,155 --> 02:51:40,990 WE TRIED OUR BEST TO THINK 3316 02:51:41,057 --> 02:51:42,492 CREATIVELY TO PROTECT ALL PEOPLE 3317 02:51:42,558 --> 02:51:51,634 IN GOVERNMENT RESEARCH. 3318 02:51:51,701 --> 02:51:52,568 >> KEVIN. 3319 02:51:52,635 --> 02:51:54,270 >> I WANT TO MAKE SURE THE 3320 02:51:54,337 --> 02:51:56,673 WORKING GROUP IS AWARE AND THE 3321 02:51:56,739 --> 02:51:57,473 RECOMMENDATIONS ARE AIMED TOWARD 3322 02:51:57,540 --> 02:52:01,811 OUR REGULATORY COLLEAGUES. 3323 02:52:01,878 --> 02:52:04,714 I WANT TO STATE CURRENTLY THE 3324 02:52:04,781 --> 02:52:09,786 NIH DOES NOT HAVE ANY, FOR 3325 02:52:09,852 --> 02:52:13,022 EXAMPLE, COLLUSION OR INCLUSION 3326 02:52:13,089 --> 02:52:14,457 REQUIREMENTS WITHIN THE 3327 02:52:14,524 --> 02:52:16,125 INCLUSION POLICIES AND I'D ALSO 3328 02:52:16,192 --> 02:52:17,760 ADD TO THE TRACKING AND 3329 02:52:17,827 --> 02:52:22,465 MONITORING QUESTION PARTLY 3330 02:52:22,532 --> 02:52:24,634 BECAUSE THERE'S NOT A LOT OF AID 3331 02:52:24,701 --> 02:52:27,437 IN TRACKING INCLUSION AND 3332 02:52:27,503 --> 02:52:34,010 LACTATING AND PREGNANT PEOPLE IN 3333 02:52:34,077 --> 02:52:34,677 CLINICAL STUDIES. 3334 02:52:34,744 --> 02:52:45,288 IT'S LOOKING AT PUBLIC RESEARCH. 3335 02:53:00,136 --> 02:53:03,406 >> I WONDER IN THE MOST RECENT 3336 02:53:03,473 --> 02:53:04,941 COMMENT IS THERE LIKE A WAY WE 3337 02:53:05,007 --> 02:53:08,311 CAN GET AT THIS MORE FROM THE 3338 02:53:08,377 --> 02:53:10,713 NIH SIDE ESPECIALLY IS THERE 3339 02:53:10,780 --> 02:53:14,317 LIKE AN EASIER WAY TO MAKE THAT 3340 02:53:14,383 --> 02:53:15,418 A REQUIREMENT FOR NIH-FUNDED 3341 02:53:15,485 --> 02:53:22,558 STUDIOS. 3342 02:53:22,625 --> 02:53:24,093 THAT'S JUST MY QUESTION AND WE 3343 02:53:24,160 --> 02:53:27,263 CAN USE THAT MORE THAN WHEN 3344 02:53:27,330 --> 02:53:28,631 PEOPLE COME TO FDA PERHAPS. 3345 02:53:28,698 --> 02:53:32,702 I DON'T KNOW. 3346 02:53:32,769 --> 02:53:34,804 >> CAN YOU SPEAK TO WHAT THE 3347 02:53:34,871 --> 02:53:41,711 PATH WOULD LOOK LIKE. 3348 02:53:41,778 --> 02:53:44,347 >> THERE'S BEEN A VARIETY OF 3349 02:53:44,413 --> 02:53:50,386 WORKSHOPS RELATED TO INCLUSION 3350 02:53:50,453 --> 02:53:52,455 ACROSS THE LIFE SPAN THE NIH HAS 3351 02:53:52,522 --> 02:53:53,389 CONDUCTED AND RECOMMENDATIONS IN 3352 02:53:53,456 --> 02:53:55,391 REGARDS TO PREGNANCY AND 3353 02:53:55,458 --> 02:53:55,658 LACTATION. 3354 02:53:55,725 --> 02:53:57,093 I'D ENCOURAGE THE WORK GROUP TO 3355 02:53:57,160 --> 02:53:58,661 LOOK AT THAT. 3356 02:53:58,728 --> 02:54:00,062 THERE'S AN INCLUSION GOVERNANCE 3357 02:54:00,129 --> 02:54:02,498 COMMITTEE AT THE NIH THAT 3358 02:54:02,565 --> 02:54:09,005 OVERSEES THAT PROCESS. 3359 02:54:09,071 --> 02:54:10,807 THAT WOULD BE THE GROUP 3360 02:54:10,873 --> 02:54:11,774 RECOMMENDATIONS WOULD NEED TO GO 3361 02:54:11,841 --> 02:54:12,708 THROUGH IN REGARDS TO THAT. 3362 02:54:12,775 --> 02:54:15,278 I'LL LEAVE IT UP TO THE WORKING 3363 02:54:15,344 --> 02:54:23,119 GROUP TO CONSIDER THAT AS IT 3364 02:54:23,186 --> 02:54:24,687 PREPARES ITS REPORT. 3365 02:54:24,754 --> 02:54:26,422 >> THANK YOU. 3366 02:54:26,489 --> 02:54:33,429 ANY OTHER THOUGHTS ON 10 THROUGH 3367 02:54:33,496 --> 02:54:34,463 10E?A 3368 02:54:34,530 --> 02:54:37,466 THROUGH 10E? 3369 02:54:37,533 --> 02:54:38,467 WE'RE TALKING BEYOND 3370 02:54:38,534 --> 02:54:39,702 IMPLEMENTATION AND TALKING ABOUT 3371 02:54:39,769 --> 02:54:40,703 OUTCOMES AND PROGRESS. 3372 02:54:40,770 --> 02:54:42,705 IT'S CLEAR WHERE THERE NEEDS TO 3373 02:54:42,772 --> 02:54:45,174 BE MORE WORK AS EVIDENCED BY THE 3374 02:54:45,241 --> 02:54:47,643 CONVERSATIONS WE'VE BEEN HEARING 3375 02:54:47,710 --> 02:54:50,813 AND ALSO CLEAR WHERE WE'VE GOT A 3376 02:54:50,880 --> 02:54:51,714 CLEAR TRAJECTORY ON SEVERAL OF 3377 02:54:51,781 --> 02:54:59,088 THESE. 3378 02:54:59,155 --> 02:55:00,857 ANY OTHER THOUGHTS FOLKS WOULD 3379 02:55:00,923 --> 02:55:02,992 LIKE TO CAPTURE AROUND 3380 02:55:03,059 --> 02:55:04,393 RECOMMENDATIONS ON 10? 3381 02:55:04,460 --> 02:55:05,761 >> IN MY WORLD DEALING WITH FDA 3382 02:55:05,828 --> 02:55:09,332 AND EMA WHEN WE GO FOR DRUG 3383 02:55:09,398 --> 02:55:09,799 STUDIES. 3384 02:55:09,866 --> 02:55:12,201 I'M OBVIOUSLY NOT THE EXPERT 3385 02:55:12,268 --> 02:55:15,471 HERE BUT CURIOUS, IS THERE ANY 3386 02:55:15,538 --> 02:55:17,406 POSSIBILITY OF THINKING WHAT 3387 02:55:17,473 --> 02:55:18,808 WE'RE WRITING FDA AND WHAT 3388 02:55:18,875 --> 02:55:20,910 THEY'RE MOVING AHEAD AND HOW 3389 02:55:20,977 --> 02:55:22,545 THAT WILL CROSSOVER WHAT EMA IS 3390 02:55:22,612 --> 02:55:23,880 DOING SINCE THEY'RE GOING 3391 02:55:23,946 --> 02:55:25,815 THROUGH THE SAME KIND OF 3392 02:55:25,882 --> 02:55:26,082 EXERCISE. 3393 02:55:26,148 --> 02:55:27,583 FOR THOSE THAT WRITE CLINICAL 3394 02:55:27,650 --> 02:55:29,552 TRIALS FOR NEW DRUGS THE LAST 3395 02:55:29,619 --> 02:55:33,456 THING I WANT TO SAY DIFFERENT 3396 02:55:33,522 --> 02:55:37,193 GUIDANCE AND DOING ALL THE 3397 02:55:37,260 --> 02:55:39,428 THINGS WITH PREGNANCY AND 3398 02:55:39,495 --> 02:55:41,030 LACTATION. 3399 02:55:41,097 --> 02:55:43,566 >> MAYBE THE AGENCY CAN SPEAK TO 3400 02:55:43,633 --> 02:55:46,168 HARMONIZATION WITH OUR PARTNERS 3401 02:55:46,235 --> 02:55:54,810 ACROSS THE OCEAN? 3402 02:55:54,877 --> 02:56:00,716 >> THIS IS LYNNE, I'M HAPPY TO 3403 02:56:00,783 --> 02:56:03,753 START AND WOULD CERTAINLY HAVE 3404 02:56:03,819 --> 02:56:04,186 COMMENTS. 3405 02:56:04,253 --> 02:56:06,188 SHARON, I THINK ONE OF THE 3406 02:56:06,255 --> 02:56:11,861 LESSONS WE LEARNED ON THE 3407 02:56:11,928 --> 02:56:14,463 PEDIATRIC SIDE AND I'M A 3408 02:56:14,530 --> 02:56:15,665 PEDIATRIC NEPHROLOGIST BY 3409 02:56:15,731 --> 02:56:18,467 TRAINING, WHEN WE HAD THESE 3410 02:56:18,534 --> 02:56:23,072 DIFFERENT LAWS AND DIFFERENT 3411 02:56:23,139 --> 02:56:26,008 REGULATI 3412 02:56:26,075 --> 02:56:31,914 REGULATIONS MOVING FORWARD IT 3413 02:56:31,981 --> 02:56:34,650 CAUSED PROBLEMS WITH ONE AGENCY 3414 02:56:34,717 --> 02:56:39,555 SAYING ONE THING AND ANOTHER 3415 02:56:39,622 --> 02:56:48,397 SAYING ANOTHER. 3416 02:56:48,464 --> 02:56:50,466 THE FOLKS ON THE INDUSTRY AND 3417 02:56:50,533 --> 02:56:57,773 REGULATORY SIDE SAW THE NEED TO 3418 02:56:57,840 --> 02:56:59,308 START THE CONVERSATION FROM THE 3419 02:56:59,375 --> 02:57:01,210 START TO GET IT MORE HARMONIZED. 3420 02:57:01,277 --> 02:57:04,413 WE HAVE THE IHC21 GUIDELINE NOW 3421 02:57:04,480 --> 02:57:07,616 BEING DEVELOPED WHICH IS A 3422 02:57:07,683 --> 02:57:12,888 HARMONIZED SHOULD BE GLOBAL 3423 02:57:12,955 --> 02:57:22,565 GUIDANCE ON THE INCLUSION AND 3424 02:57:22,631 --> 02:57:27,303 WORKING GROUP. 3425 02:57:27,370 --> 02:57:30,740 WE HAVE CREATED A GROUP OF 3426 02:57:30,806 --> 02:57:33,042 REGULATORS THAT NEED TO DISCUSS 3427 02:57:33,109 --> 02:57:38,014 TOPICS AND HAVE A PREGNANCY AND 3428 02:57:38,080 --> 02:57:38,614 LACTATION CLUSTER DEVELOPED 3429 02:57:38,681 --> 02:57:40,316 SINCE THE RECOMMENDATIONS AND 3430 02:57:40,383 --> 02:57:41,684 IT'S USEFUL IN MAKING SURE 3431 02:57:41,751 --> 02:57:42,718 THEY'RE GOING IN ALL DIFFERENT 3432 02:57:42,785 --> 02:57:50,192 DIRECTIONS. 3433 02:57:50,259 --> 02:57:51,360 WE MEDE WITH REGULATORY 3434 02:57:51,427 --> 02:57:52,294 COLLEAGUES WHEN THERE'S ISSUES 3435 02:57:52,361 --> 02:57:55,564 THAT COME UP AND WORKSHOPS AND 3436 02:57:55,631 --> 02:57:57,400 MEETINGS. 3437 02:57:57,466 --> 02:57:59,568 I THINK WE ARE -- SO YOUR POINT, 3438 02:57:59,635 --> 02:58:00,903 SHARON, WE'RE TRIGS TO DO THE 3439 02:58:00,970 --> 02:58:02,505 BEST WE CAN THERE BUT THERE'S 3440 02:58:02,571 --> 02:58:03,739 ALWAYS ROOM FOR IMPROVEMENT AND 3441 02:58:03,806 --> 02:58:06,475 I'M LOOKING FORWARD TO THE 3442 02:58:06,542 --> 02:58:14,450 RESULTS OF THIS E21 GUIDELINE TO 3443 02:58:14,517 --> 02:58:20,990 SEE THIS AS A WORKING ROAD MAP 3444 02:58:21,057 --> 02:58:29,899 THAT ALL REGULATORY AGENCIES AND 3445 02:58:29,965 --> 02:58:31,000 PHARMA GROUPS WILL HAVE TO 3446 02:58:31,067 --> 02:58:40,609 ADOPT. 3447 02:58:40,676 --> 02:58:42,678 >> I'M PLEASED YOU MENTIONED THE 3448 02:58:42,745 --> 02:58:43,112 F21. 3449 02:58:43,179 --> 02:58:45,481 THAT GUIDANCE FOR THOSE WHO 3450 02:58:45,548 --> 02:58:46,749 AREN'T FAMILIAR WILL BE ON THE 3451 02:58:46,816 --> 02:58:50,453 INCLUSION OF PREGNANT WOMEN IN 3452 02:58:50,519 --> 02:58:53,255 CLINICAL TRIALS. 3453 02:58:53,322 --> 02:58:56,725 I THINK THAT IS GOING TO BE 3454 02:58:56,792 --> 02:58:58,694 SOMETHING AND GLAD IT WAS RAISED 3455 02:58:58,761 --> 02:59:00,429 WAS IT'S SOMETHING WE SHOULD 3456 02:59:00,496 --> 02:59:03,466 SPEAK TO AS AN OPPORTUNITY FOR 3457 02:59:03,532 --> 02:59:04,633 MOVING FORWARD. 3458 02:59:04,700 --> 02:59:05,801 IT WILL CERTAINLY INFLUENCE HOW 3459 02:59:05,868 --> 02:59:06,435 WE WORK IN THE UNITED STATES AND 3460 02:59:06,502 --> 02:59:16,545 GLOBALLY. 3461 02:59:16,612 --> 02:59:19,415 I'M INTERESTING TO HEAR THE WORK 3462 02:59:19,482 --> 02:59:22,451 GROUPS, COMMENTS, THOUGHTS, 3463 02:59:22,518 --> 02:59:27,823 DIRECTION, 10E IS IMPORTANT 3464 02:59:27,890 --> 02:59:30,459 BECAUSE THERE ARE YOUNG WOMEN 3465 02:59:30,526 --> 02:59:33,295 PARTICIPATING IN STUDIES FOR NEW 3466 02:59:33,362 --> 02:59:34,930 INVESTIGATIONAL AGENTS 3467 02:59:34,997 --> 02:59:39,668 CONTINUOUSLY AND WE HAVE A GREAT 3468 02:59:39,735 --> 02:59:43,038 OPPORTUNITY HERE TO POTENTIALLY 3469 02:59:43,105 --> 02:59:45,474 GENERATE INFORMATION ACROSS THE 3470 02:59:45,541 --> 02:59:47,910 TRIMESTERS AND NOT LIKELY TO 3471 02:59:47,977 --> 02:59:48,577 GENERATE ROBUST INFORMATION BUT 3472 02:59:48,644 --> 02:59:51,247 WHERE CAN WE LOOK TO OR WHERE 3473 02:59:51,313 --> 02:59:52,314 ARE WE SEEING THERE IS PROGRESS 3474 02:59:52,381 --> 02:59:54,483 MADE IN TERMS OF IDENTIFYING A 3475 02:59:54,550 --> 02:59:57,486 PATH FORWARD TO WHAT TO DO WHEN 3476 02:59:57,553 --> 02:59:59,522 IN THE COURSE OF THE ROUTINE 3477 02:59:59,588 --> 03:00:02,491 CLINICAL STUDIES ONE OF OUR 3478 03:00:02,558 --> 03:00:08,130 PARTICIPANTS BECOMES PREGNANT? 3479 03:00:08,197 --> 03:00:13,669 >> THAT'S A GREAT QUESTION TO 3480 03:00:13,736 --> 03:00:15,337 POSE FOR THE GROUP. 3481 03:00:15,404 --> 03:00:17,373 >> I HAD A QUESTION AND WHERE 3482 03:00:17,439 --> 03:00:22,144 DOES THAT RESPONSIBILITY LIE? 3483 03:00:22,211 --> 03:00:23,712 WE TALKED ABOUT OUR COLLEAGUES 3484 03:00:23,779 --> 03:00:26,215 AT FDA A LOT AND BEING INVOLVED 3485 03:00:26,282 --> 03:00:31,120 IN MANY OF THESE THINGS BUT TO 3486 03:00:31,187 --> 03:00:32,855 ME ESPECIALLY WHEN I LOOK AT 10E 3487 03:00:32,922 --> 03:00:34,857 IT'S A QUESTION THAT WOULD BE 3488 03:00:34,924 --> 03:00:35,891 VERY WELL ANSWERED BY PEOPLE 3489 03:00:35,958 --> 03:00:37,860 DOING THIS ON A DAY TO DAY BASIS 3490 03:00:37,927 --> 03:00:40,396 AND SO I WAS WONDERING IF THERE 3491 03:00:40,462 --> 03:00:43,132 WAS ANY MOVEMENT TO BRING 3492 03:00:43,199 --> 03:00:45,467 TOGETHER A GROUP OF EXPERTS AND 3493 03:00:45,534 --> 03:00:48,771 I'M KIND OF THINKING FROM 3494 03:00:48,837 --> 03:00:50,739 INDUSTRY OR FROM INDUSTRY AND 3495 03:00:50,806 --> 03:00:54,109 ACADEMIA TO REALLY KIND OF THINK 3496 03:00:54,176 --> 03:00:56,445 THROUGH THIS BECAUSE IS I DO 3497 03:00:56,512 --> 03:00:57,413 THINK THAT MAY BE AN INTERESTING 3498 03:00:57,479 --> 03:00:59,882 WAY TO APPROACH THIS IS TO HAVE 3499 03:00:59,949 --> 03:01:03,519 THE PLAN INITIALLY DEVELOPED BY 3500 03:01:03,586 --> 03:01:05,421 FOLKS THAT ARE AROUND THESE KIND 3501 03:01:05,487 --> 03:01:13,729 OF STUDIES ON A REGULAR BASIS. 3502 03:01:13,796 --> 03:01:15,130 >> SO COMMENTS OR THOUGHTS FROM 3503 03:01:15,197 --> 03:01:19,335 THE FDA AND HOW THAT MIGHT BE 3504 03:01:19,401 --> 03:01:19,602 CONVENED? 3505 03:01:19,668 --> 03:01:29,812 HOW WE MIGHT MOVE FORWARD THERE? 3506 03:01:29,878 --> 03:01:33,482 >> I THINK YOUR IDEA VERY 3507 03:01:33,549 --> 03:01:35,951 INTERESTING. 3508 03:01:36,018 --> 03:01:43,158 LIKE WE WERE SAYING, I SEE THE 3509 03:01:43,225 --> 03:01:45,294 PART ABOUT PROTOCOL DEVELOPMENT 3510 03:01:45,361 --> 03:01:49,231 AND IT WAS ABOUT THE PRGLAC 3511 03:01:49,298 --> 03:01:50,099 STUDY PLAN. 3512 03:01:50,165 --> 03:01:58,474 THERE'S A WAY, I SUPPOSE, IF 3513 03:01:58,540 --> 03:02:00,075 CONGRESS WERE TO TAKE ACTION 3514 03:02:00,142 --> 03:02:02,544 THAT FDA COULD POTENTIALLY HAVE 3515 03:02:02,611 --> 03:02:03,479 STATUTORY AUTHORITY. 3516 03:02:03,545 --> 03:02:05,581 I'M NOT SAYING ONE WAY OR 3517 03:02:05,648 --> 03:02:08,417 ANOTHER BUT IF THEY DID IT WE 3518 03:02:08,484 --> 03:02:10,319 COULD REQUIRE THE SYSTEMATIC 3519 03:02:10,386 --> 03:02:13,022 PLANS BE DEVELOPED. 3520 03:02:13,088 --> 03:02:14,923 IT GOES BEYOND FDA HAVING THE 3521 03:02:14,990 --> 03:02:15,658 AUTHORITY OR NOT. 3522 03:02:15,724 --> 03:02:18,460 I THINK THERE'S AN OPPORTUNITY 3523 03:02:18,527 --> 03:02:21,997 HERE WHERE PEOPLE IN THE SPACE 3524 03:02:22,064 --> 03:02:24,099 DOING ON THE GROUND RUNNING 3525 03:02:24,166 --> 03:02:30,472 THESE CLINICAL TRIALS TO SAY WE 3526 03:02:30,539 --> 03:02:33,542 HAVE TO MAKE SURE THAT THE 3527 03:02:33,609 --> 03:02:35,311 PROTOCOLS UNDERSTAND IF A 3528 03:02:35,377 --> 03:02:36,979 PATIENT BECOMES PREGNANT DURING 3529 03:02:37,046 --> 03:02:38,314 CLINICAL TRIAL THIS IS THE 3530 03:02:38,380 --> 03:02:40,749 ALGORITHM WE GO THROUGH, WE MAKE 3531 03:02:40,816 --> 03:02:42,084 SURE THEY'RE FOLLOWING UP ON THE 3532 03:02:42,151 --> 03:02:43,952 OUTCOME OF THE PREGNANCY. 3533 03:02:44,019 --> 03:02:45,454 WE FOLLOW THEM AND RECONSENT 3534 03:02:45,521 --> 03:02:51,994 THEM AND MAYBE ALLOW THEM TO 3535 03:02:52,061 --> 03:02:58,334 CONTINUE THE TRIAL. 3536 03:02:58,400 --> 03:02:59,368 THERE'S AN OPPORTUNITY FOR THESE 3537 03:02:59,435 --> 03:03:02,504 PEOPLE TO KNOW WHAT NEEDS TO BE 3538 03:03:02,571 --> 03:03:08,877 DONE. 3539 03:03:08,944 --> 03:03:10,913 >> I LOVE THIS IDEA AND THINK 3540 03:03:10,979 --> 03:03:14,450 IT'S A GREAT RECOMMENDATION AS 3541 03:03:14,516 --> 03:03:23,859 WELL. 3542 03:03:23,926 --> 03:03:25,294 THE PEOPLE THAT NEED TO HERE 3543 03:03:25,361 --> 03:03:26,462 THIS ARE THE OPERATIONS PEOPLE 3544 03:03:26,528 --> 03:03:28,197 AND THEY'RE IN CHARGE OF THE 3545 03:03:28,263 --> 03:03:30,466 CLINICAL TRIALS AND MOVING THEM 3546 03:03:30,532 --> 03:03:38,774 FORWARD. 3547 03:03:38,841 --> 03:03:40,909 AND TO BE WILLING TO GET 3548 03:03:40,976 --> 03:03:42,344 INVOLVED WITH THIS SYSTEMATIC 3549 03:03:42,411 --> 03:03:44,546 PLAN OF WHAT TO DO WITH WOMEN 3550 03:03:44,613 --> 03:03:48,417 WHO BECOME PREGNANT IN THE 3551 03:03:48,484 --> 03:03:48,784 CLINICAL TRIALS. 3552 03:03:48,851 --> 03:03:52,187 I THINK IT REQUIRES BUY-IN 3553 03:03:52,254 --> 03:03:54,123 WITHIN INDUSTRY FROM DIFFERENT 3554 03:03:54,189 --> 03:03:54,890 GROUPS THAT AREN'T TYPICALLY 3555 03:03:54,957 --> 03:04:05,401 PART OF THE CONVERSATIONS. 3556 03:04:10,739 --> 03:04:20,949 >> HAVING PARTICIPATED IN THE 3557 03:04:21,016 --> 03:04:25,020 DISCUSSION AND WHEN THE MOTHER 3558 03:04:25,087 --> 03:04:28,157 DOES BABE DOES BETTER AND MANY 3559 03:04:28,223 --> 03:04:30,459 WOULD LOVE GUIDANCE FROM THE 3560 03:04:30,526 --> 03:04:40,969 EXPERTS ON HOW TO DO THIS. 3561 03:04:43,338 --> 03:04:44,706 IT GENERATES INFORMATION THAT'S 3562 03:04:44,773 --> 03:04:47,209 USEFUL FOR THE PATIENT AND 3563 03:04:47,276 --> 03:04:48,410 PROVIDE AND GENERATES 3564 03:04:48,477 --> 03:04:49,344 INFORMATION ON THE PRODUCT WOULD 3565 03:04:49,411 --> 03:04:54,349 PROBABLY BE REALLY WELCOMED. 3566 03:04:54,416 --> 03:04:55,851 I THINK A LOT OF PEOPLE WOULD BE 3567 03:04:55,918 --> 03:04:57,886 EAGER TO PARTICIPATE IN THE 3568 03:04:57,953 --> 03:04:59,655 DISCUSSION. 3569 03:04:59,721 --> 03:05:01,490 >> THIS IS GREAT CONTENT FOR THE 3570 03:05:01,557 --> 03:05:03,492 REPORT AS WE DISCUSSED AND WHERE 3571 03:05:03,559 --> 03:05:08,363 WE HAVE SEEN PROGRESS AND WHAT 3572 03:05:08,430 --> 03:05:09,465 WE MIGHT DO TO DROP BARRIERS TO 3573 03:05:09,531 --> 03:05:19,875 ADDITIONAL PROGRESS. 3574 03:05:24,913 --> 03:05:33,489 CHRISTINA AN OTHER THOUGHTS ON 3575 03:05:33,555 --> 03:05:43,866 THE CONVERSATION? 3576 03:05:56,812 --> 03:06:00,983 >> WE'RE TRYING TO PUT TOGETHER 3577 03:06:01,049 --> 03:06:03,485 THE PROGRESS REPORT AND DR. YAO 3578 03:06:03,552 --> 03:06:06,788 CAN ONLY PUT THIS TOGETHER FROM 3579 03:06:06,855 --> 03:06:09,491 THE FDA PERSPECTIVE AND ANY 3580 03:06:09,558 --> 03:06:12,528 OTHER ASPECTS TO ADVISE ON THE 3581 03:06:12,594 --> 03:06:18,467 PROGRESS TO DATE ON 10A TO 10E 3582 03:06:18,534 --> 03:06:21,470 TO MAKE SURE IT'S AS 3583 03:06:21,537 --> 03:06:32,014 REPRESENTATIVE AS POSSIBLE. 3584 03:06:33,615 --> 03:06:37,352 >> WHEN THE IMPLEMENTATION 3585 03:06:37,419 --> 03:06:39,121 REPORT CAME OUT MAYBE INDUSTRY 3586 03:06:39,187 --> 03:06:40,389 HAD RECOMMENDATIONS THEY AGREED 3587 03:06:40,455 --> 03:06:44,026 TO AND HOPEFULLY THAT THINKING 3588 03:06:44,092 --> 03:06:46,695 HAS EVOLVED IN TERMS OF 3589 03:06:46,762 --> 03:06:56,972 ARTICULATING THAT IN OUR UPDATE. 3590 03:06:57,039 --> 03:06:59,408 >> PART OF THE REASON FOR THE 3591 03:06:59,474 --> 03:07:02,344 FOOT NOTES IS THOSE 3592 03:07:02,411 --> 03:07:03,478 RECOMMENDATIONS WERE NOT ALL 3593 03:07:03,545 --> 03:07:05,581 DISCUSSED AND THEY SHOWED UP IN 3594 03:07:05,647 --> 03:07:06,481 THE DOCUMENT SO THERE WASN'T 3595 03:07:06,548 --> 03:07:07,983 OPPORTUNITY FOR ROBUST 3596 03:07:08,050 --> 03:07:08,984 DISCUSSION OR DEBATE. 3597 03:07:09,051 --> 03:07:14,756 I THINK THERE ARE CLEAR ELEMENTS 3598 03:07:14,823 --> 03:07:17,426 AGENCY AND INDUSTRY IS 100% 3599 03:07:17,492 --> 03:07:18,961 ALIGNED ON AND CLEAR ELEMENTS 3600 03:07:19,027 --> 03:07:20,495 THAT WILL NOT HAVE CHANGED FROM 3601 03:07:20,562 --> 03:07:21,863 THE TIME OF THE TASK FORCE 3602 03:07:21,930 --> 03:07:27,669 DISCUSSION. 3603 03:07:27,736 --> 03:07:29,104 >> WELL, THIS WOULD BE GREAT 3604 03:07:29,171 --> 03:07:30,172 CONVERSATION AND WOULD LIKE TO 3605 03:07:30,238 --> 03:07:32,908 TURN IT BACK TO CHRISTINA TO 3606 03:07:32,975 --> 03:07:34,042 PERHAPS TOUCH ON THE ADDITIONAL 3607 03:07:34,109 --> 03:07:35,410 ISSUES THAT WERE COMING UP IN 3608 03:07:35,477 --> 03:07:38,447 HER SESSION WE DIDN'T HAVE TIME 3609 03:07:38,513 --> 03:07:48,223 TO COVER. 3610 03:07:48,290 --> 03:07:50,158 >> THERE WAS OFFLINE DISCUSSION 3611 03:07:50,225 --> 03:07:51,493 WITH THE WORK GROUP MEMBERS. 3612 03:07:51,560 --> 03:07:52,628 I DON'T KNOW IF YOU WANT TO 3613 03:07:52,694 --> 03:07:56,164 RAISE THEM AGAIN NOW. 3614 03:07:56,231 --> 03:07:59,468 WE HAVE TIME BUT IF IT'S FELT 3615 03:07:59,534 --> 03:08:00,569 WE'VE ADDRESSED ALL YOUR FOR NOW 3616 03:08:00,636 --> 03:08:01,303 THAT'S FINE AS WELL. 3617 03:08:01,370 --> 03:08:02,804 I WANT TO GIVE YOU THAT 3618 03:08:02,871 --> 03:08:09,378 OPPORTUNITY. 3619 03:08:09,444 --> 03:08:12,280 I THINK WE CAN TAKE THE 3620 03:08:12,347 --> 03:08:21,890 RECOMMENDATION 10 SLIDE DOWN. 3621 03:08:21,957 --> 03:08:32,401 I SEE THERE IS A HAND OUT. 3622 03:08:33,368 --> 03:08:35,337 >> I WANT TO CALL OUT THE 3623 03:08:35,404 --> 03:08:36,805 DISCUSSION WE WEREN'T ABLE TO 3624 03:08:36,872 --> 03:08:38,140 HAVE ON LIABILITY EXPOSURE 3625 03:08:38,206 --> 03:08:38,974 BECAUSE IT COMES UP IN 3626 03:08:39,041 --> 03:08:41,476 RECOMMENDATION 7A. 3627 03:08:41,543 --> 03:08:42,444 I KNOW THE NATIONAL ACADEMIES 3628 03:08:42,511 --> 03:08:43,745 REPORT WILL COME OUT IN THE NEXT 3629 03:08:43,812 --> 03:08:50,452 FEW MONTHS TO GIVE EMPIRICAL 3630 03:08:50,519 --> 03:08:57,359 INFORMATION BUT IT'S IMPORTANT 3631 03:08:57,426 --> 03:08:59,594 WE MAKE THE DISTINCTION BETWEEN 3632 03:08:59,661 --> 03:09:00,662 THE PERCEPTION AND REALITY OF 3633 03:09:00,729 --> 03:09:01,263 LIABILITY. 3634 03:09:01,329 --> 03:09:02,164 THERE'S BEEN LIABILITY BUT IT'S 3635 03:09:02,230 --> 03:09:04,666 ALWAYS COME UP IN THE CONTEXT OF 3636 03:09:04,733 --> 03:09:07,335 DRUGS NOT STUDIED IN PREGNANT 3637 03:09:07,402 --> 03:09:09,504 WOMEN TALKING PREGNANCY NOT 3638 03:09:09,571 --> 03:09:19,748 LACTATION. 3639 03:09:20,882 --> 03:09:22,451 THERE'S LITTLE DATA AND GETS 3640 03:09:22,517 --> 03:09:24,152 THROWN TO A JURY AND THE JUDGE 3641 03:09:24,219 --> 03:09:26,455 IS LESS EXPERT THAN THE JURY AND 3642 03:09:26,521 --> 03:09:30,926 YOU GET WILD RESULTS IN THE JURY 3643 03:09:30,992 --> 03:09:32,327 TRIALS FEEDING TO THE LEVEL OF 3644 03:09:32,394 --> 03:09:40,669 FEAR THAT FEEDS INTO THE CULTURE 3645 03:09:40,736 --> 03:09:43,438 OF PRESUMPTIVE INCLUSION. 3646 03:09:43,505 --> 03:09:47,909 I DON'T WANT TO CONTINUE THE 3647 03:09:47,976 --> 03:09:48,543 IMPRESSION LIABILITY IS A BIG 3648 03:09:48,610 --> 03:09:50,545 THREAT WHEN IT COMES TO 3649 03:09:50,612 --> 03:09:52,514 ENROLLMENT OF TRIALS AND THERE'S 3650 03:09:52,581 --> 03:09:53,682 A CONTROLLED CIRCUMSTANCE WHERE 3651 03:09:53,749 --> 03:09:56,451 THERE'S AN OPPORTUNITY TO DECIDE 3652 03:09:56,518 --> 03:09:58,453 WHAT LEVEL OF RISK MIGHT EXIST 3653 03:09:58,520 --> 03:10:03,492 AND COUNSEL THEM AND MINIMIZE 3654 03:10:03,558 --> 03:10:06,261 AND REACT THE MOMENT IT SEEMS 3655 03:10:06,328 --> 03:10:10,465 THERE'S A PROBLEM AND COUPLED 3656 03:10:10,532 --> 03:10:13,568 WITH THE FACT IT PROVES YOU'RE 3657 03:10:13,635 --> 03:10:16,471 CREATE PROTECTIVE SITUATION AND 3658 03:10:16,538 --> 03:10:19,241 7A POPPED OUT TALKING ABOUT 3659 03:10:19,307 --> 03:10:21,143 MITIGATION MEASURES AIMED AT 3660 03:10:21,209 --> 03:10:22,210 REDIVING LIABILITY EXPOSURE IF 3661 03:10:22,277 --> 03:10:26,014 I'M REMEMBERING IT CORRECTLY. 3662 03:10:26,081 --> 03:10:27,015 THAT'S BUYING INTO THE 3663 03:10:27,082 --> 03:10:28,750 UNDERLYING ASSUMPTION I DON'T 3664 03:10:28,817 --> 03:10:36,458 THINK IS I EMPIRICALLY JUSTIFIE. 3665 03:10:36,525 --> 03:10:38,960 >> I THINK YOU'RE CORRECT THERE 3666 03:10:39,027 --> 03:10:40,562 WAS A DISCUSSION AND THE 3667 03:10:40,629 --> 03:10:41,496 QUESTION OF LIABILITY RISK IN 3668 03:10:41,563 --> 03:10:47,402 REGARDS TO EVERY STAKEHOLDER 3669 03:10:47,469 --> 03:10:50,472 PARTICIPAT 3670 03:10:50,539 --> 03:10:52,474 PARTICIPATING AND IT'S TRICKLING 3671 03:10:52,541 --> 03:10:57,212 DOWN STREAM AND THE BEST 3672 03:10:57,279 --> 03:11:01,650 APPROACH FOR 7 IS GETTING AN 3673 03:11:01,716 --> 03:11:02,584 OPPORTUNITY TO DISCUSS WHEN WE 3674 03:11:02,651 --> 03:11:08,023 HAVE THE FACE TO FACE BECAUSE IT 3675 03:11:08,089 --> 03:11:18,633 NEEDS DISCUSSION TO ENSURE THIS. 3676 03:11:50,498 --> 03:11:53,101 >> AND ACADEMIC INSTITUTIONS ARE 3677 03:11:53,168 --> 03:11:54,436 EXTREMELY CONSERVATIVE IN THIS 3678 03:11:54,502 --> 03:11:56,238 WAY AND CONCERNED ABOUT 3679 03:11:56,304 --> 03:11:57,505 LIABILITY CORRECTLY OR 3680 03:11:57,572 --> 03:12:00,775 INCORRECTLY, ACCURATELY OR NOT 3681 03:12:00,842 --> 03:12:02,077 AND IT FEEDS INTO THE CULTURAL 3682 03:12:02,143 --> 03:12:02,611 ISSUE THAT CAME UP IN THE 3683 03:12:02,677 --> 03:12:07,949 COMMENT. 3684 03:12:08,016 --> 03:12:10,452 THAT PROBABLY UNDER LIES HOW 3685 03:12:10,518 --> 03:12:11,753 EFFECTIVE OTHER THINGS LIKE 3686 03:12:11,820 --> 03:12:16,157 GUIDANCE CAN BE IF IT'S BASED ON 3687 03:12:16,224 --> 03:12:19,094 AN INSTITUTIONAL CONSERVATIVE 3688 03:12:19,160 --> 03:12:20,262 AND FEAR ON LIABILITY 3689 03:12:20,328 --> 03:12:25,500 UNJUSTIFIED OR NOT YOU CAN 3690 03:12:25,567 --> 03:12:30,038 REMOVE THINGS FROM REGULATION 3691 03:12:30,105 --> 03:12:31,539 THERE'S STILL AN UNDERLYING 3692 03:12:31,606 --> 03:12:33,541 CONCERN AND MAY WANT TO KEEP IT 3693 03:12:33,608 --> 03:12:34,442 IN MIND AS WE MAKE 3694 03:12:34,509 --> 03:12:44,786 RECOMMENDATION. 3695 03:12:59,100 --> 03:13:01,069 >> IT'S BEEN A CHALLENGE YOU'RE 3696 03:13:01,136 --> 03:13:03,972 BEING ASKED TO DO A LOT OF WORK 3697 03:13:04,039 --> 03:13:08,076 AND HAVE COMMENTS ON WHAT LED TO 3698 03:13:08,143 --> 03:13:11,780 THE RECOMMENDATIONS BEING MADE 3699 03:13:11,846 --> 03:13:14,449 AND WE'RE BEING ASKED TO GIVE A 3700 03:13:14,516 --> 03:13:16,384 SNAPSHOT OF ACTIVITIES SO I WANT 3701 03:13:16,451 --> 03:13:18,453 TO THANK YOU ALL BECAUSE THIS IS 3702 03:13:18,520 --> 03:13:22,457 ASKING A LOT OF YOU. 3703 03:13:22,524 --> 03:13:31,066 GO AHEAD, KEVIN. 3704 03:13:31,132 --> 03:13:35,737 >> I WANT TO GIVE A QUICK UPDATE 3705 03:13:35,804 --> 03:13:37,639 ON THE RULES MY OFFICE IS 3706 03:13:37,706 --> 03:13:42,911 DEVELOPING I WAS JUST INFORMED 3707 03:13:42,978 --> 03:13:45,480 THE DATE THE DATE IS PUBLISH. 3708 03:13:45,547 --> 03:13:46,681 THE GOAL DATE IS FOR THE END OF 3709 03:13:46,748 --> 03:13:55,523 THE CALENDAR YEAR. 3710 03:13:55,590 --> 03:14:02,130 THE DATES CAN SOMETIMES SLIP FOR 3711 03:14:02,197 --> 03:14:03,498 A LOT OF REASONS AND AIMING FOR 3712 03:14:03,565 --> 03:14:12,841 THE END OF THE CALENDAR YEAR. 3713 03:14:12,907 --> 03:14:13,975 THANK YOU, KEVIN. 3714 03:14:14,042 --> 03:14:15,810 >> I'LL TURN TO YOU AND YOU CAN 3715 03:14:15,877 --> 03:14:18,446 GO FROM THERE. 3716 03:14:18,513 --> 03:14:23,985 >> I'LL RE-ECHO THE SENTIMENT TO 3717 03:14:24,052 --> 03:14:24,252 YOU. 3718 03:14:24,319 --> 03:14:26,054 WE REALIZE HOW MUCH WORK THE 3719 03:14:26,121 --> 03:14:27,989 GROUP IS DOING ESPECIALLY 3720 03:14:28,056 --> 03:14:29,224 OFFLINE AND THANK YOU FOR TAKING 3721 03:14:29,290 --> 03:14:31,760 THE TIME TO ARTICULATE YOUR 3722 03:14:31,826 --> 03:14:33,428 COMMENTS IN THE MEETING CHAT. 3723 03:14:33,495 --> 03:14:37,399 AGAIN, ALL THOSE ARE GETTING 3724 03:14:37,465 --> 03:14:38,133 CAPTURED AND THANK YOU VERY MUCH 3725 03:14:38,199 --> 03:14:40,402 FOR MAKING SURE WE HAVE A STRONG 3726 03:14:40,468 --> 03:14:42,504 ROBUST DISCUSSION AND SO WE'VE 3727 03:14:42,570 --> 03:14:44,105 GOT ONE MORE MEETING AHEAD OF 3728 03:14:44,172 --> 03:14:44,539 US. 3729 03:14:44,606 --> 03:14:49,511 PLEASE BE PATIENT AS WE CONTINUE 3730 03:14:49,577 --> 03:14:53,214 TO ROLL THROUGH THESE AND EMMA 3731 03:14:53,281 --> 03:14:57,252 BACK TO YOU NOW. 3732 03:14:57,318 --> 03:15:01,423 >> THANK YOU, SUE. 3733 03:15:01,823 --> 03:15:05,493 >> WE FINISHED OUR MATERIAL UP A 3734 03:15:05,560 --> 03:15:07,796 SHORTER TIME THAN ANTICIPATED SO 3735 03:15:07,862 --> 03:15:09,397 WE HAVE DOWN TIME ON OUR FRIDAY. 3736 03:15:09,464 --> 03:15:12,200 A COUPLE ANNOUNCEMENTS OR 3737 03:15:12,267 --> 03:15:13,501 UPDATES FROM US. 3738 03:15:13,568 --> 03:15:21,342 I DID PUT THIS IN THE CHAT BUT 3739 03:15:21,409 --> 03:15:22,944 THE REPORT WON'T BE RELEASED 3740 03:15:23,011 --> 03:15:24,446 UNTIL LATER BUT WE'RE WORKING ON 3741 03:15:24,512 --> 03:15:26,448 SETTING UP A BRIEFING ONCE THAT 3742 03:15:26,514 --> 03:15:30,452 REPORT IS OUT. 3743 03:15:30,518 --> 03:15:32,887 IT WILL BE OPTIONAL FOR THE 3744 03:15:32,954 --> 03:15:38,259 GROUP BUT MAY BE INFORMATIVE TO 3745 03:15:38,326 --> 03:15:41,029 OUR REPORT AND WE'LL BE DRAFTING 3746 03:15:41,096 --> 03:15:41,563 IN THE SPRING. 3747 03:15:41,629 --> 03:15:46,468 KEEP AN EYE OUT FOR THE DATE 3748 03:15:46,534 --> 03:15:51,306 LIKELY IN EARLY APRIL. 3749 03:15:51,372 --> 03:15:54,008 FOR OUR NEXT MEETING, MARCH 22 3750 03:15:54,075 --> 03:15:59,714 WE'RE INTENDING TO HOLD IT IN 3751 03:15:59,781 --> 03:16:03,551 PERSON IN BETHESDA AND THIS IS 3752 03:16:03,618 --> 03:16:04,953 SPONSORED TRAVEL YOU SHOULD HEAR 3753 03:16:05,019 --> 03:16:07,822 FROM LESLIE McCLAIN OUR 3754 03:16:07,889 --> 03:16:08,490 CONTRACTOR SUPPORTING THIS GROUP 3755 03:16:08,556 --> 03:16:11,860 ABOUT ARRANGING THE TRAVEL 3756 03:16:11,926 --> 03:16:14,129 INCLUDING FLIGHTS AND HOTEL FOR 3757 03:16:14,195 --> 03:16:18,600 THAT AND VERY MUCH LOOKING 3758 03:16:18,666 --> 03:16:19,868 FORWARD TO THE OPPORTUNITY TO 3759 03:16:19,934 --> 03:16:25,073 GET TO MEET YOU IN PERSON FOR 3760 03:16:25,140 --> 03:16:26,908 THAT AND FINALLY FOR OUR 3761 03:16:26,975 --> 03:16:28,576 POST-MEETING WORK WE WILL WORK 3762 03:16:28,643 --> 03:16:31,980 ON A SIMILAR DOCUMENT TO THE 3763 03:16:32,046 --> 03:16:33,047 DOCUMENT FOR RECOMMENDATION 13. 3764 03:16:33,114 --> 03:16:38,353 THE GOAL STO GET THAT SENT TO 3765 03:16:38,419 --> 03:16:41,322 YOU BY JANUARY 29 BY THE END OF 3766 03:16:41,389 --> 03:16:44,726 THE DAY AND ASKING TO RETURN BY 3767 03:16:44,792 --> 03:16:45,126 FEBRUARY 12. 3768 03:16:45,193 --> 03:16:47,061 WE'LL SYNTHESIZE THE COUGHINGS 3769 03:16:47,128 --> 03:16:48,496 IN THE DOCUMENT AND GET THAT OUT 3770 03:16:48,563 --> 03:16:50,465 TO YOU ALONG WITH THE SLIDES 3771 03:16:50,532 --> 03:16:54,135 FROM THE SPEAKERS TODAY. 3772 03:16:54,202 --> 03:16:56,204 I THINK WE CAN CLOSE OUT UNLESS 3773 03:16:56,271 --> 03:16:58,806 ANYBODY HAS QUESTIONS THE LAST 3774 03:16:58,873 --> 03:16:59,307 LOGISTICAL PIECES OF 3775 03:16:59,374 --> 03:17:00,742 INFORMATION. 3776 03:17:00,808 --> 03:17:03,111 >> I DO HAVE ONE QUESTION, THIS 3777 03:17:03,178 --> 03:17:04,412 IS ALISON. 3778 03:17:04,479 --> 03:17:08,750 I WANTED TO KNOW WILL THE 3779 03:17:08,816 --> 03:17:09,617 COMMENTS AND REFERENCES IN THE 3780 03:17:09,684 --> 03:17:15,790 CHAT ALL BE PART OF THE FORMAL 3781 03:17:15,857 --> 03:17:26,000 MINUTES? 3782 03:17:29,370 --> 03:17:30,438 >> WONDERING IF YOU'RE GOING TO 3783 03:17:30,505 --> 03:17:36,277 DOWNLOAD THAT OR CAPTURE THAT. 3784 03:17:36,344 --> 03:17:38,913 >> WE'LL CAPTURE THE CHAT IN THE 3785 03:17:38,980 --> 03:17:40,582 MINUTES AND I ALSO HAVE I'LL 3786 03:17:40,648 --> 03:17:42,450 DOWNLOAD THE ENTIRE TRANSCRIPT 3787 03:17:42,517 --> 03:17:43,885 OF THE CHAT IF ANYBODY WANTS TO 3788 03:17:43,952 --> 03:17:47,789 REVIEW IT SOONER THAN THE 3789 03:17:47,855 --> 03:17:50,325 MINUTES ARE AVAILABLE. 3790 03:17:50,391 --> 03:17:52,093 AND THE MARCH 22 MEETING WILL BE 3791 03:17:52,160 --> 03:17:58,366 AT LEAST PARTIALLY OPEN TO THE 3792 03:17:58,433 --> 03:18:06,441 PUBLIC. 3793 03:18:06,507 --> 03:18:11,713 OTHER QUESTIONS? 3794 03:18:11,779 --> 03:18:12,914 OKAY. 3795 03:18:12,981 --> 03:18:15,383 WELL, CHRISTINA, ANY LAST WORDS. 3796 03:18:15,450 --> 03:18:17,385 >> THANK YOU AGAIN TO THE GROUP 3797 03:18:17,452 --> 03:18:18,853 AND A VERY BIG THANK YOU. 3798 03:18:18,920 --> 03:18:23,758 I FORGOT TO MENTION THIS TO OUR 3799 03:18:23,825 --> 03:18:26,494 COLLEAGUES AT NICHD WHO WORKED 3800 03:18:26,561 --> 03:18:29,797 DILIGENTLY BEHIND THE SCENES SO 3801 03:18:29,864 --> 03:18:32,900 MAKE SURE WE PREPARED TODAY. 3802 03:18:32,967 --> 03:18:37,005 >> AND THANKS TO PALLADIUM FOR 3803 03:18:37,071 --> 03:18:38,439 HELPING US OUT FOR THE MEETING. 3804 03:18:38,506 THANK YOU, EVERYBODY.