1 00:00:05,240 --> 00:00:10,440 WELCOME TO THE ANNUAL ICCVAM 2 00:00:10,440 --> 00:00:15,000 PUBLIC FORUM. 3 00:00:15,000 --> 00:00:17,640 I'M ANNA LOWIT WITH JOHN GORDON, 4 00:00:17,640 --> 00:00:20,720 THE CHAIRS OF THE INTERAINGE SHY 5 00:00:20,720 --> 00:00:21,800 COORDINATING COMMITTEE FOR 6 00:00:21,800 --> 00:00:23,960 VALIDATION OF ALTERNATIVE 7 00:00:23,960 --> 00:00:24,200 METHODS. 8 00:00:24,200 --> 00:00:25,200 IT'S ACTUALLY -- THERE ARE A FEW 9 00:00:25,200 --> 00:00:31,400 OF US IN THE ROOM, NICE TO SEE 10 00:00:31,400 --> 00:00:33,080 ACTUAL FACES, GOOD TO HAVE SO 11 00:00:33,080 --> 00:00:34,040 MANY PEOPLE ONLINE LISTENING. 12 00:00:34,040 --> 00:00:38,360 IT'S GOING TO BE A FUN TWO DAYS. 13 00:00:38,360 --> 00:00:40,240 , ONE OF MY FAVORITE ICCVAM 14 00:00:40,240 --> 00:00:44,600 EVENTS ON THE CALENDAR TO LISTEN 15 00:00:44,600 --> 00:00:46,920 TO ALL OF OUR COLLEAGUES AND THE 16 00:00:46,920 --> 00:00:48,400 COOL THINGS THEY HAVE BEEN 17 00:00:48,400 --> 00:00:48,600 DOING. 18 00:00:48,600 --> 00:00:50,600 I ALWAYS COME OUT OF THE MEETING 19 00:00:50,600 --> 00:00:52,240 INVIGORATED TO DO SOMETHING NEW 20 00:00:52,240 --> 00:00:55,080 AND COOL, SO IT'S GOING TO BE A 21 00:00:55,080 --> 00:00:58,680 FUN DAY AND A HALF, AND WITH 22 00:00:58,680 --> 00:01:00,800 THAT GLAD YOU'RE HERE TO JOIN US 23 00:01:00,800 --> 00:01:05,480 AND DAVE ALLEN IS GOING TO HELP, 24 00:01:05,480 --> 00:01:06,560 WE'LL GO AROUND THE ROOM 25 00:01:06,560 --> 00:01:09,080 PHYSICALLY AND HE WILL BE 26 00:01:09,080 --> 00:01:15,280 CALLING OUT THE NAMES ONLINE. 27 00:01:15,280 --> 00:01:23,640 >> DAVE ALLEN, SUPPORTING 28 00:01:23,640 --> 00:01:23,880 NICEATM. 29 00:01:23,880 --> 00:01:25,160 >> NICOLE KLEINSTREUER. 30 00:01:25,160 --> 00:01:35,640 >> JOHN GORDON, CO-CHAIR OF 31 00:01:40,040 --> 00:01:40,240 ICCVAM. 32 00:01:40,240 --> 00:01:47,720 >> MONIQUE PERRON, EPA. 33 00:01:47,720 --> 00:01:48,960 >> SUZANNE FITZPATRICK, FDA. 34 00:01:48,960 --> 00:01:52,120 >> JESSICA LEET, RESEARCH 35 00:01:52,120 --> 00:02:00,160 TOXICOLOGIST U.S.GS AND DOI. 36 00:02:00,160 --> 00:02:03,840 >> (INDISCERNIBLE) PHYSICIAN 37 00:02:03,840 --> 00:02:06,800 COMMITTEE FOR RESPONSIBLE 38 00:02:06,800 --> 00:02:07,080 MEDICINE. 39 00:02:07,080 --> 00:02:10,640 >> ANDERSON, COMMITTEE FOR 40 00:02:10,640 --> 00:02:11,120 RESPONSIBLE MEDICINE. 41 00:02:11,120 --> 00:02:21,480 >> EMILY BRANDON, TOX 42 00:02:24,440 --> 00:02:37,560 DOLLINGIST. 43 00:02:37,560 --> 00:02:45,600 >> SCIENCE CONSORTIUM 44 00:02:45,600 --> 00:02:47,600 DR. JOHN GORDON WILL TALK ABOUT 45 00:02:47,600 --> 00:02:50,200 U.S. CONSUMER PRODUCT COMMISSION 46 00:02:50,200 --> 00:02:53,800 PROGRESS ON NAMs. 47 00:02:53,800 --> 00:02:55,200 >> ALL RIGHT. 48 00:02:55,200 --> 00:02:56,520 WELL, THANK YOU FOR COMING. 49 00:02:56,520 --> 00:02:58,400 FOR THOSE ON THE WEBCAST, THANK 50 00:02:58,400 --> 00:03:00,400 YOU AS WELL. 51 00:03:00,400 --> 00:03:03,880 I AGREE WITH ANNA, THIS IS A 52 00:03:03,880 --> 00:03:04,640 FANTASTIC DAY. 53 00:03:04,640 --> 00:03:05,240 I'M GLAD I'M GOING TO GO FIRST 54 00:03:05,240 --> 00:03:06,880 AND SIT BACK THE REST OF THE 55 00:03:06,880 --> 00:03:10,840 TALKS AND LISTEN THE REST OF THE 56 00:03:10,840 --> 00:03:12,280 TIME HERE. 57 00:03:12,280 --> 00:03:13,560 I THANK DAVE ALLEN FOR BAILING 58 00:03:13,560 --> 00:03:17,520 ME OUT OF PARKING JAIL THIS 59 00:03:17,520 --> 00:03:18,080 MORNING. 60 00:03:18,080 --> 00:03:20,240 WE HAD A SNAFU WITH THE ENTRY 61 00:03:20,240 --> 00:03:22,440 LIST, DAVE HAD TO LET US IN. 62 00:03:22,440 --> 00:03:24,200 ANYWAY, I WANT TO TALK ABOUT 63 00:03:24,200 --> 00:03:29,440 WHAT WE'RE WORKING ON AT THE 64 00:03:29,440 --> 00:03:31,320 CPSC, AND JUST WHAT WE'VE BEEN 65 00:03:31,320 --> 00:03:32,080 WORKING ON THERE. 66 00:03:32,080 --> 00:03:33,920 LET ME FIGURE OUT HOW TO MAKE 67 00:03:33,920 --> 00:03:34,680 THIS WORK. 68 00:03:34,680 --> 00:03:37,320 I DID, ALL RIGHT, GREAT. 69 00:03:37,320 --> 00:03:38,760 TWO THINGS, SOME OF YOU HAVE 70 00:03:38,760 --> 00:03:42,160 SEEN THE STUFF ON THE GUIDANCE 71 00:03:42,160 --> 00:03:44,880 BEFORE, IT WILL BE DIFFERENT. 72 00:03:44,880 --> 00:03:45,880 ALSO THE WEB PAGE UPDATE, THIS 73 00:03:45,880 --> 00:03:47,640 IS GOING TO BE A NICE SURPRISE 74 00:03:47,640 --> 00:03:51,320 BECAUSE WE DO HAVE A LIVE UPDATE 75 00:03:51,320 --> 00:03:55,280 FOR THE SHOW. 76 00:03:55,280 --> 00:03:57,120 ALL RIGHT. 77 00:03:57,120 --> 00:03:58,560 BACKGROUND. 78 00:03:58,560 --> 00:03:59,760 SUBSTANCE ACT REQUIRES 79 00:03:59,760 --> 00:04:02,040 CAUTIONARY LABELING ON CONSUMER 80 00:04:02,040 --> 00:04:04,360 PRODUCTS FOR POTENTIAL HAZARDS 81 00:04:04,360 --> 00:04:07,200 TO CONSUMERS BUT DOES NOT 82 00:04:07,200 --> 00:04:08,520 REQUIRE ANY SPECIFIC TESTING 83 00:04:08,520 --> 00:04:10,720 BEING DONE WHICH MEANS YOU CAN 84 00:04:10,720 --> 00:04:12,440 USE NAMs IN THESE SITUATIONS. 85 00:04:12,440 --> 00:04:18,040 YOU DON'T HAVE TO USE IT. 86 00:04:18,040 --> 00:04:20,600 FOR TOXICITY TESTING FOR 87 00:04:20,600 --> 00:04:22,080 IRRITATION YOU DON'T NEED TO USE 88 00:04:22,080 --> 00:04:23,160 THE ANIMAL TEST. 89 00:04:23,160 --> 00:04:25,920 YOU CAN USE NAMs. 90 00:04:25,920 --> 00:04:30,080 IN FACT, THE 2012 CPSC POLICY 91 00:04:30,080 --> 00:04:32,360 STRONGLY ENCOURAGES USE OF 92 00:04:32,360 --> 00:04:33,480 ALTERNATIVE METHODS TO ALLEVIATE 93 00:04:33,480 --> 00:04:36,440 PAIN AND SUFFERING WHICH WE'RE 94 00:04:36,440 --> 00:04:43,880 ALL AWARE OF. 95 00:04:43,880 --> 00:04:45,080 POLICY ENCOURAGES EXISTING DATA, 96 00:04:45,080 --> 00:04:47,440 HUMAN DATA, PRIOR ANIMAL 97 00:04:47,440 --> 00:04:48,520 TESTING, EXPERT JUDGMENT, 98 00:04:48,520 --> 00:04:50,360 NAMs, AND USING NEW ANIMAL 99 00:04:50,360 --> 00:04:54,880 TESTING AS A LAST RESORT. 100 00:04:54,880 --> 00:04:57,120 AND THIS IS THE TITLE FOR THE 101 00:04:57,120 --> 00:05:02,640 GUIDANCE DOCUMENT. 102 00:05:02,640 --> 00:05:04,960 IT'S FOR THE METHODS, AND FOR 103 00:05:04,960 --> 00:05:08,440 THE DATA ASSOCIATED WITH THOSE 104 00:05:08,440 --> 00:05:10,800 METHODS. 105 00:05:10,800 --> 00:05:13,000 GUIDING PRINCIPLES OF THE 106 00:05:13,000 --> 00:05:15,760 METHODS, WE WANT TO ENSURE THE 107 00:05:15,760 --> 00:05:17,720 METHOD IS PROPERLY REVIEWED FOR 108 00:05:17,720 --> 00:05:19,040 ACCURACY AND ROBUSTNESS. 109 00:05:19,040 --> 00:05:23,520 SO WE HAVE CONFIDENCE IN THE 110 00:05:23,520 --> 00:05:24,840 METHOD WE'RE BRINGING FORWARD, 111 00:05:24,840 --> 00:05:27,880 SHOWING THE DATA PERTAINS TO THE 112 00:05:27,880 --> 00:05:31,840 CPSC DOMAIN OF WHAT WE ACTUALLY 113 00:05:31,840 --> 00:05:32,360 REGULATE. 114 00:05:32,360 --> 00:05:34,240 SO IF SOMETHING'S BEEN ONLY 115 00:05:34,240 --> 00:05:37,640 TESTED ON PESTICIDES MAY OR MAY 116 00:05:37,640 --> 00:05:41,240 NOT BE EFFICIENTLY REVIEWED FOR 117 00:05:41,240 --> 00:05:48,000 CPSC 118 00:05:48,000 --> 00:05:50,440 CPSC SINCE WE DON'T LOOK AT 119 00:05:50,440 --> 00:05:51,080 PESTICIDES. 120 00:05:51,080 --> 00:05:53,960 WE LOOK AT COMPLEX MIXTURES AND 121 00:05:53,960 --> 00:05:55,440 FINISHED PRODUCTS, WE DON'T 122 00:05:55,440 --> 00:05:57,240 REGULATE INDIVIDUAL CHEMICALS. 123 00:05:57,240 --> 00:06:05,960 THAT'S AN FDA, EPA, AND OTHER 124 00:06:05,960 --> 00:06:06,240 AGENCIES. 125 00:06:06,240 --> 00:06:09,800 GUIDANCE OVERVIEW, SIMILAR TO 126 00:06:09,800 --> 00:06:11,440 THE VALIDATION WORK GUIDANCE, 127 00:06:11,440 --> 00:06:15,040 WHICH WE'LL HEAR ABOUT LATER, 128 00:06:15,040 --> 00:06:22,400 THE DOCUMENT IS NOT MANDATORY. 129 00:06:22,400 --> 00:06:24,840 EVERYTHING WILL BE EVALUATED ON 130 00:06:24,840 --> 00:06:25,920 CASE-BY-CASE BASIS REQUIRING 131 00:06:25,920 --> 00:06:27,080 EXPERT PROFESSIONAL JUDGMENT. 132 00:06:27,080 --> 00:06:30,280 IT'S NOT A CHECKLIST OR 133 00:06:30,280 --> 00:06:32,120 BLUEPRINT FOR JUST OBTAINING 134 00:06:32,120 --> 00:06:32,400 APPROVAL. 135 00:06:32,400 --> 00:06:34,320 AND IF ACCEPTED, THE SUBMITTED 136 00:06:34,320 --> 00:06:36,080 METHOD WILL BE VALID AND 137 00:06:36,080 --> 00:06:39,040 ACCEPTABLE FOR A SPECIFIC 138 00:06:39,040 --> 00:06:40,120 PURPOSE. 139 00:06:40,120 --> 00:06:41,120 CONTAINS AN OPTIONAL NOMINATION 140 00:06:41,120 --> 00:06:43,720 FORM SO YOU CAN NOMINATE THE 141 00:06:43,720 --> 00:06:46,560 METHOD, ORGANIZE THE INFORMATION 142 00:06:46,560 --> 00:06:48,320 FOR US SPEEDING UP THE PROCESS. 143 00:06:48,320 --> 00:06:51,200 IF YOU WANT TO NOMINATE A METHOD 144 00:06:51,200 --> 00:06:53,800 FOR CPSC TO REVIEW, PLEASE DO 145 00:06:53,800 --> 00:06:54,760 SO. 146 00:06:54,760 --> 00:06:55,640 THAT'S WHAT THIS GUIDANCE 147 00:06:55,640 --> 00:06:57,840 DOCUMENT IS ALL ABOUT, SO 148 00:06:57,840 --> 00:06:59,040 DEVELOPERS CAN NOMINATE THEIR 149 00:06:59,040 --> 00:07:04,280 METHODS, GET THEM TO US, AND 150 00:07:04,280 --> 00:07:08,160 SPEED THE PROCESS ALONG AND HELP 151 00:07:08,160 --> 00:07:13,400 OUT WITH USING NAMs FOR CPSC 152 00:07:13,400 --> 00:07:16,920 TO DO TOXICOLOGICAL EVALUATIONS. 153 00:07:16,920 --> 00:07:19,360 THE GUIDANCE DOCUMENT ITSELF, 154 00:07:19,360 --> 00:07:24,680 THE FR NOTICE WAS PUBLISHED IN 155 00:07:24,680 --> 00:07:26,160 MARCH OF 2021, FIVE PUBLIC 156 00:07:26,160 --> 00:07:28,280 COMMENTS, THANK YOU, THEY WERE 157 00:07:28,280 --> 00:07:30,480 VERY HELPFUL. 158 00:07:30,480 --> 00:07:33,240 FINAL VERSION WAS APPROVED IN 159 00:07:33,240 --> 00:07:35,240 APRIL OF 2022, UNANIMOUS VOTE OF 160 00:07:35,240 --> 00:07:36,960 COMMISSION, AND THEY WERE HAPPY 161 00:07:36,960 --> 00:07:39,040 TO HAVE THIS OUT, AND FINAL 162 00:07:39,040 --> 00:07:41,760 VERSION WAS PUBLISHED IN APRIL 163 00:07:41,760 --> 00:07:42,440 OF 2022. 164 00:07:42,440 --> 00:07:48,120 AND WE HAVE IT ON OUR WEBSITE 165 00:07:48,120 --> 00:07:49,440 BUT WE ALSO RECOGNIZE 166 00:07:49,440 --> 00:07:51,320 REGULATIONS.GOV IS GENERALLY THE 167 00:07:51,320 --> 00:07:52,960 REPOSITORY FOR SUCH DOCUMENTS, 168 00:07:52,960 --> 00:07:55,240 SO IT'S GOOD TO BOOKMARK THAT IF 169 00:07:55,240 --> 00:07:59,600 YOU'RE INTERESTED IN HAVING THE 170 00:07:59,600 --> 00:07:59,880 DOCUMENT. 171 00:07:59,880 --> 00:08:01,400 AND NOW WE HAVE A WEB PAGE 172 00:08:01,400 --> 00:08:01,560 UPDATE THAT I WOULD LIKE TO SHOW YOU 173 00:08:01,560 --> 00:08:05,280 WE'VE REDESIGNED THE WEB PAGE, 174 00:08:05,280 --> 00:08:11,120 FIVE SECTIONS, WE'LL MOVE THE 175 00:08:11,120 --> 00:08:11,400 MICROPHONE. 176 00:08:11,400 --> 00:08:13,760 FIRST SECTION IS ON THE ANIMAL 177 00:08:13,760 --> 00:08:16,160 TESTING POLICY, THE SAME AS 178 00:08:16,160 --> 00:08:17,160 NORMAL ANIMAL TESTING POLICY 179 00:08:17,160 --> 00:08:20,960 WE'VE ALWAYS HAD. 180 00:08:20,960 --> 00:08:24,880 THE NEXT CLICKABLE SECTION IS 181 00:08:24,880 --> 00:08:26,880 THE GUIDANCE DOCUMENT ITSELF. 182 00:08:26,880 --> 00:08:29,920 IT'S WORKING NOW? 183 00:08:29,920 --> 00:08:30,280 GREAT. 184 00:08:30,280 --> 00:08:40,760 NOW YOU CAN SEE WHAT I'VE GOT 185 00:08:40,760 --> 00:08:40,960 HERE. 186 00:08:40,960 --> 00:08:42,960 THE SECOND SECTION, IF YOU COULD 187 00:08:42,960 --> 00:08:44,040 PULL DOWN MENU, GUIDANCE 188 00:08:44,040 --> 00:08:45,920 DOCUMENT ITSELF IS IN THERE, A 189 00:08:45,920 --> 00:08:47,680 SUMMARY OF THE GUIDANCE 190 00:08:47,680 --> 00:08:50,000 DOCUMENT, AND THE NEXT SECTION 191 00:08:50,000 --> 00:08:52,840 DEFINITIONS HAS SOME REALLY GOOD 192 00:08:52,840 --> 00:08:58,440 LINKS TO THE FHSA, CHRONIC 193 00:08:58,440 --> 00:09:00,200 HAZARD GUIDELINE, SEVERAL 194 00:09:00,200 --> 00:09:04,520 DEFINITIONS WITHIN THE FHSA 195 00:09:04,520 --> 00:09:12,760 ITSELF ON TOXICITY. 196 00:09:12,760 --> 00:09:18,760 THE NEXT SECTION, CPSC-APPROVED 197 00:09:18,760 --> 00:09:20,600 METHODS, HARD TO READ, THAT 198 00:09:20,600 --> 00:09:24,040 CONTAINS THE LIST OF ALL THE 199 00:09:24,040 --> 00:09:25,440 METHODS THAT CPSC REVIEWED, AND 200 00:09:25,440 --> 00:09:31,880 IN THAT SECTION YOU CAN SEE A 201 00:09:31,880 --> 00:09:33,040 BRIEF DESCRIPTION OF THE METHOD, 202 00:09:33,040 --> 00:09:36,000 ON THE NEXT SLIDE. 203 00:09:36,000 --> 00:09:39,360 YEAH, THIS SECTION HERE HAS A 204 00:09:39,360 --> 00:09:41,920 TITLE OF COURSE, CONTACT 205 00:09:41,920 --> 00:09:43,640 INFORMATION, BRIEF DESCRIPTION, 206 00:09:43,640 --> 00:09:45,840 THE STAFF RECOMMENDATIONS ON USE 207 00:09:45,840 --> 00:09:47,480 FOR THIS METHOD, AND THE 208 00:09:47,480 --> 00:09:49,640 DOCUMENT ITSELF IS CLICKABLE. 209 00:09:49,640 --> 00:09:52,320 YOU CAN DOWNLOAD A PDF OF 210 00:09:52,320 --> 00:09:53,840 BRIEFING PACKAGES ON EACH OF THE 211 00:09:53,840 --> 00:09:56,200 METHODS, SO YOU CAN SEE WHAT 212 00:09:56,200 --> 00:09:59,560 CPSC HAS DONE AND WHAT WE 213 00:09:59,560 --> 00:10:02,840 RECOMMEND AND FIND THESE IN THE 214 00:10:02,840 --> 00:10:04,800 FOIA PAGE OF OUR CPSC WEBSITE 215 00:10:04,800 --> 00:10:06,520 WHICH I WAS GOING TO SHOW YOU AS 216 00:10:06,520 --> 00:10:09,480 WELL BUT WE CAN'T GET THERE. 217 00:10:09,480 --> 00:10:15,640 SO ESSENTIALLY WHAT WE HAVE HERE 218 00:10:15,640 --> 00:10:17,600 IS THE FREQUENTLY ASKED 219 00:10:17,600 --> 00:10:18,760 QUESTIONS, GOOD IF YOU HAVE 220 00:10:18,760 --> 00:10:20,760 QUESTIONS, ALSO IF YOU NEWED TO 221 00:10:20,760 --> 00:10:22,440 GET HOLD OF US, SIMPLY THE WEB 222 00:10:22,440 --> 00:10:28,320 ADDRESS UP HERE AT THE TOP 223 00:10:28,320 --> 00:10:29,000 ALTERNATIVE METHODS, DIRECTLY TO 224 00:10:29,000 --> 00:10:39,520 MYSELF AND OTHER PEOPLE IN THE 225 00:10:42,880 --> 00:10:43,680 HEALTH SCIENCES DEPARTMENT. 226 00:10:43,680 --> 00:10:45,120 THIS EFFORT IS GOOD FOR FEDERAL 227 00:10:45,120 --> 00:10:47,640 AGENCIES TO TAKE OVER AND MAKE 228 00:10:47,640 --> 00:10:49,720 SURE WE HAVE CLARITY. 229 00:10:49,720 --> 00:10:52,200 WE DO NEED CONFIDENCE, IT'S VERY 230 00:10:52,200 --> 00:10:55,040 IMPORTANT TO HAVE CONFIDENCE IN 231 00:10:55,040 --> 00:10:56,160 THESE METHODS AND IMPORTANT TO 232 00:10:56,160 --> 00:10:57,600 BE CLEAR HOW WE'RE GOING TO USE 233 00:10:57,600 --> 00:10:59,520 THESE METHODS AND HOW THE PUBLIC 234 00:10:59,520 --> 00:11:02,920 CAN USE THESE METHODS WITH 235 00:11:02,920 --> 00:11:04,800 FEDERAL AGENCIES. 236 00:11:04,800 --> 00:11:06,240 HAVE CONFIDENCE AND CLARITY, 237 00:11:06,240 --> 00:11:07,160 DREAMILY IMPORTANT. 238 00:11:07,160 --> 00:11:09,240 WE CAN'T EXPECT THE DEVELOPERS 239 00:11:09,240 --> 00:11:11,800 OR TESTING LABS TO PUT TWO AND 240 00:11:11,800 --> 00:11:12,880 TWO TOGETHER AND SAY, OH, THIS 241 00:11:12,880 --> 00:11:14,000 IS HOW THIS IS DONE. 242 00:11:14,000 --> 00:11:19,360 WE NEED TO BE VERY CLEAR ABOUT 243 00:11:19,360 --> 00:11:20,880 WHAT WE'RE -- HOW WE'RE GOING TO 244 00:11:20,880 --> 00:11:22,600 USE METHODS AND WHAT WE USE THEM 245 00:11:22,600 --> 00:11:22,760 FOR. 246 00:11:22,760 --> 00:11:25,680 DOESN'T MEAN THEY CAN'T BE USED 247 00:11:25,680 --> 00:11:27,120 FOR OTHER THINGS BUT WHAT WE DO 248 00:11:27,120 --> 00:11:29,040 KNOW AND ESTABLISH WE NEED TO BE 249 00:11:29,040 --> 00:11:30,280 CLEAR ON. 250 00:11:30,280 --> 00:11:32,160 I THINK NICOLE AND SOME OTHERS 251 00:11:32,160 --> 00:11:37,640 ARE WORKING ON A PLAN TO LOOK AT 252 00:11:37,640 --> 00:11:39,920 TOXICITY ENDPOINT, MARRYING THAT 253 00:11:39,920 --> 00:11:44,440 WITH THE NAM AND PATHWAY AND KEY 254 00:11:44,440 --> 00:11:45,880 EVENTS, OECD METHODS THAT MAP TO 255 00:11:45,880 --> 00:11:48,080 THAT AND I THINK THAT'S GOING TO 256 00:11:48,080 --> 00:11:53,960 BE VERY GOOD AT ADDING CLARITY 257 00:11:53,960 --> 00:11:57,760 TO HOW YOU GO ABOUT DOING 258 00:11:57,760 --> 00:12:02,360 TOXICITY, SOMETHING AS SIMPLE AS 259 00:12:02,360 --> 00:12:03,720 A FLOWCHART SHOWING OECD METHOD 260 00:12:03,720 --> 00:12:06,560 123 TO THIS EVENT OR PATHWAY, 261 00:12:06,560 --> 00:12:08,800 AND GOES TO THIS TOXICITY 262 00:12:08,800 --> 00:12:10,840 ENDPOINT. 263 00:12:10,840 --> 00:12:12,560 VERY GOOD TO HAVE THOSE FOR 264 00:12:12,560 --> 00:12:13,040 CLARITY. 265 00:12:13,040 --> 00:12:14,840 WE CAN'T EXPECT THE REGULATORY 266 00:12:14,840 --> 00:12:16,360 AFFAIRS OFFICIALS OR WHOEVER IS 267 00:12:16,360 --> 00:12:18,480 MAKING THE DECISIONS TO DO THIS 268 00:12:18,480 --> 00:12:18,680 WORK. 269 00:12:18,680 --> 00:12:20,720 THEY HAVE THE CLEAR PATH ON HOW 270 00:12:20,720 --> 00:12:24,080 THEY KNOW HOW TO DO STUFF, WITH 271 00:12:24,080 --> 00:12:24,960 THEIR ANIMAL STUDIES. 272 00:12:24,960 --> 00:12:26,800 THEY AREN'T GOING TO GO ON THIS 273 00:12:26,800 --> 00:12:28,320 OTHER PATH UNLESS WE MAKE IT 274 00:12:28,320 --> 00:12:29,960 VERY CLEAR TO THEM HOW TO USE 275 00:12:29,960 --> 00:12:33,560 THESE METHODS IN THEIR 276 00:12:33,560 --> 00:12:35,880 REGULATORY ACCEPTANCE. 277 00:12:35,880 --> 00:12:42,200 SO I THINK THAT'S IT FOR ME. 278 00:12:42,200 --> 00:12:42,600 [APPLAUSE] 279 00:12:42,600 --> 00:12:43,640 THANK YOU. 280 00:12:43,640 --> 00:12:47,600 WHO IS OUR NEXT SPEAKER? 281 00:12:47,600 --> 00:12:49,640 OKAY. 282 00:12:49,640 --> 00:12:52,520 >> SO WE DO HAVE A MINUTE FOR A 283 00:12:52,520 --> 00:12:55,800 BRIEF CLARIFYING QUESTION IN THE 284 00:12:55,800 --> 00:12:56,040 ROOM. 285 00:12:56,040 --> 00:13:06,240 OR ONLINE. 286 00:13:08,360 --> 00:13:12,000 >> GREAT PRESENTATION, JOHN. 287 00:13:12,000 --> 00:13:15,280 APPRECIATE IT. 288 00:13:15,280 --> 00:13:18,640 CPSC OBVIOUSLY COVERS PRODUCT 289 00:13:18,640 --> 00:13:19,440 CATEGORIES, FORMULATIONS, 290 00:13:19,440 --> 00:13:21,600 COMPLEX MATERIALS, AND CLEARLY 291 00:13:21,600 --> 00:13:23,160 ALL THE VALIDATED TEST METHODS 292 00:13:23,160 --> 00:13:25,680 HAVE GONE TO VALIDATION OF 293 00:13:25,680 --> 00:13:27,440 INDIVIDUAL DISCRETE CHEMICALS 294 00:13:27,440 --> 00:13:28,000 AND INGREDIENTS. 295 00:13:28,000 --> 00:13:31,000 SO A LOT OF LITERATURE TALKS 296 00:13:31,000 --> 00:13:32,680 ABOUT LIMITATIONS, APPLICATIONS 297 00:13:32,680 --> 00:13:35,520 FOR CHEMICAL INGREDIENTS, AND 298 00:13:35,520 --> 00:13:38,240 SOME LIMITATIONS ARE NOT 299 00:13:38,240 --> 00:13:39,680 RELEVANT TO TESTING COMPLEX 300 00:13:39,680 --> 00:13:40,000 FORMULATIONS. 301 00:13:40,000 --> 00:13:42,480 MY QUESTION WOULD BE WITH THE 302 00:13:42,480 --> 00:13:45,880 GUIDANCE AND GUIDANCE DOCUMENT 303 00:13:45,880 --> 00:13:47,520 HERE, FOCUSING ON VALIDATED 304 00:13:47,520 --> 00:13:48,840 METHODS USING INGREDIENTS ALONE, 305 00:13:48,840 --> 00:13:52,240 IS THERE A MECHANISM TO UPDATE 306 00:13:52,240 --> 00:13:54,960 THE GUIDANCE TO INTERPRET DATA 307 00:13:54,960 --> 00:13:58,480 FROM TEST METHODS ON COMPLEX 308 00:13:58,480 --> 00:14:01,000 FORMULATIONS RECOGNIZING THERE'S 309 00:14:01,000 --> 00:14:02,400 COMPLEX FORMULATIONS TESTED BY 310 00:14:02,400 --> 00:14:03,480 INDUSTRY IN A NON-REGULATORY 311 00:14:03,480 --> 00:14:07,440 SETTING FOR MANY YEARS AND HAVE 312 00:14:07,440 --> 00:14:08,880 BEEN ABLE TO WIDEN THE SCOPE, 313 00:14:08,880 --> 00:14:11,400 WHICH IS LIMITED BY LIMITATIONS 314 00:14:11,400 --> 00:14:14,680 OF INGREDIENTS TESTING 315 00:14:14,680 --> 00:14:14,960 APPROACHES. 316 00:14:14,960 --> 00:14:15,760 >> OKAY. 317 00:14:15,760 --> 00:14:19,680 YEAH, WE DEFINITELY LIKE THE 318 00:14:19,680 --> 00:14:24,960 IDEA OF TEST ED ON COMPLEX 319 00:14:24,960 --> 00:14:26,600 MATERIALS BUT MOST HAVE NOT BEEN 320 00:14:26,600 --> 00:14:30,080 OR CANNOT BE SO WE DO LOOK AT 321 00:14:30,080 --> 00:14:32,160 INDIVIDUAL COMPONENTS OF A 322 00:14:32,160 --> 00:14:35,320 COMPLEX MIXTURE DURING TOXICITY 323 00:14:35,320 --> 00:14:36,560 ASSESSMENT FOR COMPLEX MIXTURES. 324 00:14:36,560 --> 00:14:39,600 WE ALSO LOOK AT EXPOSURE 325 00:14:39,600 --> 00:14:43,360 SCENARIOS AS WELL, SOMETHING 326 00:14:43,360 --> 00:14:45,960 THAT THE PAINT ON THE INSIDE OF 327 00:14:45,960 --> 00:14:48,160 A MARBLE MAY BE TOXIC BUT NOT 328 00:14:48,160 --> 00:14:48,440 ACCESSIBLE. 329 00:14:48,440 --> 00:14:53,400 >> I MIGHT ADD BRIEFLY A LOT OF 330 00:14:53,400 --> 00:14:54,600 END USERS, CROs HAVE QUITE A 331 00:14:54,600 --> 00:14:56,640 BUILT OF EXPERIENCE IN TESTING 332 00:14:56,640 --> 00:14:59,520 COMPLEX FORMULATIONS WITH THESE 333 00:14:59,520 --> 00:15:00,920 NAMs, WHICH OFFER THE 334 00:15:00,920 --> 00:15:03,080 OPPORTUNITY TO SHARE IN OUR 335 00:15:03,080 --> 00:15:04,640 KNOWLEDGE BASE AND HELP 336 00:15:04,640 --> 00:15:06,280 UNDERSTAND HOW THESE METHODS CAN 337 00:15:06,280 --> 00:15:09,360 BE USED OUTSIDE THE SCOPE OF 338 00:15:09,360 --> 00:15:10,560 SIMPLY INGREDIENT TESTING, FROM 339 00:15:10,560 --> 00:15:12,080 OUR ORGANIZATION AS WELL. 340 00:15:12,080 --> 00:15:15,080 >> ANY ABILITY TO HELP US 341 00:15:15,080 --> 00:15:16,920 UNDERSTAND HOW TO USE NAMs 342 00:15:16,920 --> 00:15:23,040 BETTER AND MAKE IT CLEARER FOR 343 00:15:23,040 --> 00:15:24,280 FOLKS, THERE'S ANOTHER C, 344 00:15:24,280 --> 00:15:28,200 CLARITY, WE NEED TO SPEND TIME 345 00:15:28,200 --> 00:15:28,600 ON. 346 00:15:28,600 --> 00:15:30,840 COOPERATING BETWEEN BUSINESSES 347 00:15:30,840 --> 00:15:33,040 OUT THERE WHO HAVE A GOOD IDEA 348 00:15:33,040 --> 00:15:35,080 WHAT WE ACTUALLY NEED IS A 349 00:15:35,080 --> 00:15:37,480 REALLY GOOD IDEA. 350 00:15:37,480 --> 00:15:39,360 AND SETTING UP WEBINAR OR 351 00:15:39,360 --> 00:15:43,480 WHATEVER WE NEED TO DO TO 352 00:15:43,480 --> 00:15:46,120 PROVIDE THAT INFORMATION WOULD 353 00:15:46,120 --> 00:15:48,560 BE FANTASTIC, AND ALLOWING CPSC 354 00:15:48,560 --> 00:15:49,520 SPECIFICALLY TO UNDERSTAND 355 00:15:49,520 --> 00:15:50,320 MIXTURES. 356 00:15:50,320 --> 00:15:51,960 THE FDA AND EPA OBVIOUSLY HAVE 357 00:15:51,960 --> 00:15:54,560 NEED FOR THAT TOO. 358 00:15:54,560 --> 00:15:58,520 FDA WITH THEIR MEDICAL DEVICES, 359 00:15:58,520 --> 00:16:00,480 ON A PRACTICAL LEVEL, MEDICAL 360 00:16:00,480 --> 00:16:02,000 DEVICES AND CONSUMER PRODUCTS 361 00:16:02,000 --> 00:16:04,120 ARE VERY SIMILAR. 362 00:16:04,120 --> 00:16:05,440 THEY ARE METAL, PLASTIC, RUBBER. 363 00:16:05,440 --> 00:16:07,240 THEY NEED TO BE TESTED. 364 00:16:07,240 --> 00:16:09,840 SO FROM THAT POINT OF VIEW, I 365 00:16:09,840 --> 00:16:12,320 THINK FDA AND CPSC WOULD BENEFIT 366 00:16:12,320 --> 00:16:16,480 GREATLY FROM KNOWLEDGE FROM ANY 367 00:16:16,480 --> 00:16:20,000 GROUP ON MIXTURES TESTING THAT 368 00:16:20,000 --> 00:16:26,160 WE COULD GET ANY INFORMATION 369 00:16:26,160 --> 00:16:26,720 WOULD BE GREAT. 370 00:16:26,720 --> 00:16:31,600 >> ONE QUESTION IF THERE'S 371 00:16:31,600 --> 00:16:32,320 TIME. 372 00:16:32,320 --> 00:16:33,080 >> VERY QUICKLY. 373 00:16:33,080 --> 00:16:35,320 >> OECD TEST GUIDELINES ARE NOT 374 00:16:35,320 --> 00:16:38,280 AUTOMATICALLY ADDED TO THE LIST, 375 00:16:38,280 --> 00:16:39,720 FOR SKIN SENSITIZATION I SEE 376 00:16:39,720 --> 00:16:43,640 NNLA BUT NOT THE NEWER IN VITRO 377 00:16:43,640 --> 00:16:44,400 TESTING APPROACHES. 378 00:16:44,400 --> 00:16:45,640 >> YEAH, ANY METHOD IS ALLOWED 379 00:16:45,640 --> 00:16:46,840 TO BE USED. 380 00:16:46,840 --> 00:16:49,680 WHAT WE DO IS REVIEW THEM TO 381 00:16:49,680 --> 00:16:51,320 MAKE THEM EASIER AND MORE 382 00:16:51,320 --> 00:16:52,200 OBVIOUS, MORE CLARITY, BECAUSE 383 00:16:52,200 --> 00:16:54,840 IF I DON'T REVIEW IT OR SOMEBODY 384 00:16:54,840 --> 00:16:56,480 AT CPSC DOESN'T REVIEW THIS 385 00:16:56,480 --> 00:16:57,440 METHOD I DOUBT ANYBODY'S GOING 386 00:16:57,440 --> 00:16:59,400 TO USE IT BECAUSE THEY ARE NOT 387 00:16:59,400 --> 00:17:02,360 GOING TO KNOW, OKAY, THIS NO 388 00:17:02,360 --> 00:17:04,080 METHOD, HOW IS CPSC GOING TO 389 00:17:04,080 --> 00:17:04,400 ACCEPT THIS? 390 00:17:04,400 --> 00:17:05,880 I DON'T KNOW SO I'M NOT GOING TO 391 00:17:05,880 --> 00:17:06,760 USE IT. 392 00:17:06,760 --> 00:17:09,120 THAT'S WHY I LIKE REVIEWING 393 00:17:09,120 --> 00:17:10,800 THEM, PUTTING THEM ON THE 394 00:17:10,800 --> 00:17:11,720 WEBSITE FOR CLARITY, WE'VE 395 00:17:11,720 --> 00:17:12,760 REVIEWED THIS, THIS IS GOOD. 396 00:17:12,760 --> 00:17:14,960 BECAUSE IF WE DON'T LET THE 397 00:17:14,960 --> 00:17:17,920 DEVELOPERS OR TESTING LABS KNOW 398 00:17:17,920 --> 00:17:18,920 WHAT WE DO, A LOT OF TIMES THEY 399 00:17:18,920 --> 00:17:20,480 WILL MOVE TO SOMETHING ELSE. 400 00:17:20,480 --> 00:17:23,160 >> SOMEONE NEEDS TO SUBMIT A 401 00:17:23,160 --> 00:17:28,520 NOMINATION FOR THOSE METHODS OR 402 00:17:28,520 --> 00:17:28,680 -- 403 00:17:28,680 --> 00:17:29,640 >>ANYBODY CAN NOMINATE A 404 00:17:29,640 --> 00:17:29,920 METHOD. 405 00:17:29,920 --> 00:17:31,280 IF YOU SEE A METHOD THAT YOU 406 00:17:31,280 --> 00:17:33,680 THINK WOULD BE HELPFUL, USED BY 407 00:17:33,680 --> 00:17:36,520 INDUSTRY, PLEASE NOMINATE IT. 408 00:17:36,520 --> 00:17:37,800 409 00:17:37,800 --> 00:17:40,200 >> GREAT. 410 00:17:40,200 --> 00:17:46,880 THANK YOU SO MUCH, JOHN. 411 00:17:46,880 --> 00:17:51,600 412 00:17:51,600 --> 00:17:52,080 OKAY. 413 00:17:52,080 --> 00:17:53,880 IT'S MY PLEASURE TO INTRODUCE 414 00:17:53,880 --> 00:17:55,440 MONIQUE PERRON TO GIVE AN UPDATE 415 00:17:55,440 --> 00:17:57,200 FROM EPA OFFICE OF PESTICIDE 416 00:17:57,200 --> 00:17:58,920 PROGRAMS, ALSO FOR THE FOLKS 417 00:17:58,920 --> 00:18:00,360 WATCHING ON THE WEBCAST WE DO 418 00:18:00,360 --> 00:18:02,960 HAVE AN E-MAIL ADDRESS YOU CAN 419 00:18:02,960 --> 00:18:04,760 SEND QUESTIONS IN TO, AND WE'LL 420 00:18:04,760 --> 00:18:06,160 HAVE TIME LATER IN THE DAY AND 421 00:18:06,160 --> 00:18:10,400 TOMORROW TO COME BACK TO ANY OF 422 00:18:10,400 --> 00:18:12,080 THOSE QUESTIONS. 423 00:18:12,080 --> 00:18:12,960 ICCVAMQUESTIONSNIEHS AT NIH.GOV, 424 00:18:12,960 --> 00:18:14,480 WE'LL MAKE SURE TO PUT THAT ON 425 00:18:14,480 --> 00:18:15,680 THE SLIDE THAT'S SHOWING DURING 426 00:18:15,680 --> 00:18:20,200 THE BREAK WHEN WE BREAK AFTER 427 00:18:20,200 --> 00:18:22,480 THE NEXT TALK. 428 00:18:22,480 --> 00:18:26,760 MONIQUE, OVER TO YOU. 429 00:18:26,760 --> 00:18:29,360 >> THANK YOU, NICOLE. 430 00:18:29,360 --> 00:18:31,680 THANK YOU, EVERYONE, FOR 431 00:18:31,680 --> 00:18:32,320 JOINING. 432 00:18:32,320 --> 00:18:33,400 I'M GOING TO GIVE -- PROVIDE AN 433 00:18:33,400 --> 00:18:34,840 UPDATE ON ACTIVITIES THAT ARE 434 00:18:34,840 --> 00:18:37,080 ONGOING AT THE OFFICE OF 435 00:18:37,080 --> 00:18:40,040 PESTICIDE PROGRAMS AT THE UNITED 436 00:18:40,040 --> 00:18:41,000 STATES ENVIRONMENTAL PROTECTION 437 00:18:41,000 --> 00:18:41,240 AGENCY. 438 00:18:41,240 --> 00:18:43,960 AS ALWAYS, WE LIKE TO INCLUDE 439 00:18:43,960 --> 00:18:47,360 OUR DISCLAIMER THAT THE VIEWS I 440 00:18:47,360 --> 00:18:48,880 EXPRESS MAY NOT NECESSARILY 441 00:18:48,880 --> 00:18:50,200 REPRESENT THOSE OF THE AGENCY. 442 00:18:50,200 --> 00:18:52,520 I WANTED TO START OFF WITH WE 443 00:18:52,520 --> 00:18:54,520 PROVIDED A FEW UPDATES ON OUR 444 00:18:54,520 --> 00:18:57,000 NAM WORK PLAN, IN THE PAST FEW 445 00:18:57,000 --> 00:18:57,560 YEARS. 446 00:18:57,560 --> 00:19:00,080 WE PUT OUT ORIGINAL WORKPLAN, 447 00:19:00,080 --> 00:19:02,680 THEN UPDATED IT SOON AFTER THAT 448 00:19:02,680 --> 00:19:06,440 IN 2021, BUT THE OBJECTIVES OF 449 00:19:06,440 --> 00:19:09,440 THAT WERE ESSENTIALLY UNTOUCHED. 450 00:19:09,440 --> 00:19:11,200 AND ONE OF OF THE ONES I WANTED 451 00:19:11,200 --> 00:19:14,520 TO FOCUS ON IS ONE OF THE 452 00:19:14,520 --> 00:19:16,760 OBJECTIVES OR GOALS TO ESTABLISH 453 00:19:16,760 --> 00:19:18,120 SCIENTIFIC CONFIDENCE, AND AS 454 00:19:18,120 --> 00:19:20,960 PART OF THAT THE AGENCY IS 455 00:19:20,960 --> 00:19:23,800 WORKING ON A CONFIDENCE 456 00:19:23,800 --> 00:19:24,880 FRAMEWORK, SCIENCE CONFIDENCE 457 00:19:24,880 --> 00:19:26,440 FRAMEWORK, AND LUCKILY FOR US 458 00:19:26,440 --> 00:19:27,480 THIS ISN'T STARTING FROM 459 00:19:27,480 --> 00:19:28,120 SCRATCH. 460 00:19:28,120 --> 00:19:30,040 THERE'S A LOT OF DIFFERENT 461 00:19:30,040 --> 00:19:31,480 FRAMEWORKS, AND DOCUMENTS OUT 462 00:19:31,480 --> 00:19:34,400 THERE, THAT WE'RE TRYING TO 463 00:19:34,400 --> 00:19:35,280 BUILD OFF OF AND CONSIDER. 464 00:19:35,280 --> 00:19:40,680 ONE OF THE MOST RECENT ONES WAS 465 00:19:40,680 --> 00:19:43,160 PUBLISHED IN 2022, WHICH IS IN 466 00:19:43,160 --> 00:19:44,280 THE BOTTOM RIGHT-HAND CORNER 467 00:19:44,280 --> 00:19:44,800 HERE. 468 00:19:44,800 --> 00:19:48,960 AND WHAT YOU SEE ACROSS A LOT OF 469 00:19:48,960 --> 00:19:50,520 THESE FRAMEWORKS IS VERY 470 00:19:50,520 --> 00:19:53,680 CONSISTENT COMPONENTS OF A 471 00:19:53,680 --> 00:19:55,760 FRAMEWORK AND SO FOR EPA WE'RE 472 00:19:55,760 --> 00:20:02,960 WORKING TO DO A SCIENTIFIC 473 00:20:02,960 --> 00:20:05,480 CONFIDENCE FRAMEWORK MORE 474 00:20:05,480 --> 00:20:10,040 GENERALIZABLE APPLICABLE TO A 475 00:20:10,040 --> 00:20:11,040 BROAD RANGE OF NAMs. 476 00:20:11,040 --> 00:20:15,240 DECISIONS I MAKE IN THE OFFICE 477 00:20:15,240 --> 00:20:16,200 OF PESTICIDE PROGRAMS ARE 478 00:20:16,200 --> 00:20:17,640 ACCORDING TO STATUTES WE NEED TO 479 00:20:17,640 --> 00:20:19,800 FOLLOW WHILE OUR COLLUSION IN 480 00:20:19,800 --> 00:20:21,240 POLLUTION PREVENTION AND TOXICS 481 00:20:21,240 --> 00:20:23,000 LOOKING AT INDUSTRIAL CHEMICALS 482 00:20:23,000 --> 00:20:25,040 HAVE TO CONSIDER OTHER 483 00:20:25,040 --> 00:20:25,800 REGULATORY CONTEXT. 484 00:20:25,800 --> 00:20:28,560 SO IT'S TRYING TO KEEP THIS MUCH 485 00:20:28,560 --> 00:20:31,080 MORE BROAD SO WE CAN UTILIZE 486 00:20:31,080 --> 00:20:35,160 THIS FRAMEWORK ACROSS DIFFERENT 487 00:20:35,160 --> 00:20:36,360 PARTS OF THE AGENCY. 488 00:20:36,360 --> 00:20:38,320 THERE'S A LOT OF DIFFERENT 489 00:20:38,320 --> 00:20:40,400 ONGOING ACTIVITIES RELATED TO 490 00:20:40,400 --> 00:20:42,280 THAT AS WELL. 491 00:20:42,280 --> 00:20:46,280 JUST LAST FALL WE HAD OUR THIRD 492 00:20:46,280 --> 00:20:47,320 CONFERENCE FOR STATE OF THE 493 00:20:47,320 --> 00:20:48,720 SCIENCE ON THE DEVELOPMENT AND 494 00:20:48,720 --> 00:20:50,680 USE OF NEW APPROACH METHODS FOR 495 00:20:50,680 --> 00:20:52,280 CHEMICAL SAFETY. 496 00:20:52,280 --> 00:20:54,760 THAT WAS IN OCTOBER, 2022. 497 00:20:54,760 --> 00:20:57,160 AND RECENTLY THE REPORT CAME OUT 498 00:20:57,160 --> 00:21:00,040 SO YOU CAN SEE ALL OF THE 499 00:21:00,040 --> 00:21:01,360 PRESENTATIONS AND DISCUSSIONS, 500 00:21:01,360 --> 00:21:03,200 WE HAD BREAKOUT GROUPS TO TALK 501 00:21:03,200 --> 00:21:04,200 ABOUT THE FRAMEWORK IN 502 00:21:04,200 --> 00:21:06,600 PARTICULAR, AND IN THE 503 00:21:06,600 --> 00:21:08,640 COMPONENTS THAT WOULD GO INTO 504 00:21:08,640 --> 00:21:08,840 THAT. 505 00:21:08,840 --> 00:21:09,520 ADDITIONAL WHICH YOU'LL HEAR 506 00:21:09,520 --> 00:21:11,080 WILL LATER IN THE MEETING WE'VE 507 00:21:11,080 --> 00:21:14,160 BEEN ACTIVE IN THE VALIDATION 508 00:21:14,160 --> 00:21:16,800 WORK GROUP FOR ICCVAM, THAT'S 509 00:21:16,800 --> 00:21:18,320 TASKED WITH UPDATING VALIDATION 510 00:21:18,320 --> 00:21:20,160 GUIDANCE AND ADDITIONAL HAVE A 511 00:21:20,160 --> 00:21:22,840 PANEL CONVENED AT THE NATIONAL 512 00:21:22,840 --> 00:21:25,880 ACADEMY OF SCIENCES TO LOOK AT 513 00:21:25,880 --> 00:21:28,480 THE VARIABILITY AND RELEVANCE OF 514 00:21:28,480 --> 00:21:30,160 CURRENT MAMMALIAN TOXICITY 515 00:21:30,160 --> 00:21:32,320 STUDIES AND ALSO DIFFERENT 516 00:21:32,320 --> 00:21:33,880 CONFIDENCE FRAMEWORKS AND, 517 00:21:33,880 --> 00:21:36,400 AGAIN, TO INFORM WHAT COMPONENTS 518 00:21:36,400 --> 00:21:38,840 WE SHOULD BE CONSIDERING TO 519 00:21:38,840 --> 00:21:40,440 INCORPORATE INTO OUR SCIENTIFIC 520 00:21:40,440 --> 00:21:40,880 CONFIDENCE FRAMEWORK. 521 00:21:40,880 --> 00:21:46,280 A LOT OF WORK GOING ON THERE. 522 00:21:46,280 --> 00:21:47,520 HOPEFULLY THAT WILL GIVE 523 00:21:47,520 --> 00:21:48,640 GUIDANCE TO STAKEHOLDERS TO KNOW 524 00:21:48,640 --> 00:21:49,960 WHAT WE'RE LOOKING FOR WHEN WE 525 00:21:49,960 --> 00:21:51,720 NEED TO -- BECAUSE WE'RE TRYING 526 00:21:51,720 --> 00:21:53,680 TO MAKE REGULATORY DECISIONS AND 527 00:21:53,680 --> 00:21:57,960 NEED TO BE CONFIDENT IN THE 528 00:21:57,960 --> 00:21:58,960 UNDERLYING SCIENCE. 529 00:21:58,960 --> 00:22:01,160 SO FOR QUITE A LONG TIME, OUR 530 00:22:01,160 --> 00:22:03,760 COLLEAGUES IN THE OFFICE OF 531 00:22:03,760 --> 00:22:05,600 RESEARCH AND DEVELOPMENT HAVE 532 00:22:05,600 --> 00:22:08,680 BEEN TAKING PART IN 533 00:22:08,680 --> 00:22:09,680 INTERNATIONAL EFFORT TO DEVELOP 534 00:22:09,680 --> 00:22:13,200 IN VITRO ASSAYS THAT ARE PART OF 535 00:22:13,200 --> 00:22:16,560 A BATTERY TO EVALUATE 536 00:22:16,560 --> 00:22:19,520 DEVELOPMENTAL NEUROTOXICITY 537 00:22:19,520 --> 00:22:19,800 POTENTIAL. 538 00:22:19,800 --> 00:22:21,920 THIS BATTERY, A LARGE PORTION OF 539 00:22:21,920 --> 00:22:24,520 IT, WAS DEVELOPED BY RESEARCH IN 540 00:22:24,520 --> 00:22:27,520 ORD, AND THE BATTERY WAS ALSO 541 00:22:27,520 --> 00:22:33,200 BROUGHT TO OUR FIFRA PANEL IN 542 00:22:33,200 --> 00:22:33,400 2020. 543 00:22:33,400 --> 00:22:37,160 RECENTLY IN MARCH 2023 WE PUT A 544 00:22:37,160 --> 00:22:38,240 RESPONSE TO THE SAP 545 00:22:38,240 --> 00:22:41,760 RECOMMENDATIONS AND COMMENTS 546 00:22:41,760 --> 00:22:42,800 INTO THE DOCKET, ON THE SLIDE 547 00:22:42,800 --> 00:22:46,640 YOU CAN SEE A DOCKET LINK IF YOU 548 00:22:46,640 --> 00:22:49,760 WANT TO GO TO THE DOCUMENT. 549 00:22:49,760 --> 00:22:58,080 ULTIMATELY RESPONDING TO SOME 550 00:22:58,080 --> 00:22:59,080 RECOMMENDATIONS, PROVIDING 551 00:22:59,080 --> 00:23:00,240 CLARIFYING INFORMATION AND 552 00:23:00,240 --> 00:23:01,200 ADDITIONAL INFORMATION TO 553 00:23:01,200 --> 00:23:04,080 IDENTIFY COMMENTS IN THE SAP 554 00:23:04,080 --> 00:23:04,400 REPORT. 555 00:23:04,400 --> 00:23:09,960 AND THE WORK DOESN'T STOP THERE. 556 00:23:09,960 --> 00:23:11,840 THERE'S BEEN ONGOING WORK AT 557 00:23:11,840 --> 00:23:14,800 OECD LEVEL WITH THIS BATTERY AS 558 00:23:14,800 --> 00:23:17,600 WELL, AND WE'RE HAPPY TO SEE 559 00:23:17,600 --> 00:23:20,200 THAT AT THE RECENT WNT MEETING 560 00:23:20,200 --> 00:23:22,280 IN APRIL 2023 THE GUIDANCE ON 561 00:23:22,280 --> 00:23:26,240 EVALUATION OF DATA FROM THE 562 00:23:26,240 --> 00:23:27,920 BATTERY WAS ACCEPTED, SO THAT 563 00:23:27,920 --> 00:23:32,640 WAS WONDERFUL NEWS, SO WE HOPE 564 00:23:32,640 --> 00:23:34,840 TO SEE ADDITIONAL ORGANIZATIONS 565 00:23:34,840 --> 00:23:35,560 LOOKING TO UTILIZE THIS 566 00:23:35,560 --> 00:23:37,240 INFORMATION AS PART OF THEIR 567 00:23:37,240 --> 00:23:46,600 WEIGHT OF EVIDENCE FOR DNT 568 00:23:46,600 --> 00:23:46,880 POTENTIAL. 569 00:23:46,880 --> 00:23:48,160 OPP AS WELL AS COLLEAGUES IN 570 00:23:48,160 --> 00:23:55,840 OFFICE OF POLLUTION AND 571 00:23:55,840 --> 00:23:57,360 PREVENTION, OPT PROVIDED 572 00:23:57,360 --> 00:23:58,240 CHEMICAL NOMINATIONS IN THE 573 00:23:58,240 --> 00:24:00,200 FIRST ROUND AS WELL AS SECOND 574 00:24:00,200 --> 00:24:03,160 ROUND STARTING TO GET PULLED 575 00:24:03,160 --> 00:24:03,520 TOGETHER. 576 00:24:03,520 --> 00:24:05,880 AND THEN LASTLY I JUST ALSO 577 00:24:05,880 --> 00:24:08,600 WANTED TO NOTE THAT DATA FROM 578 00:24:08,600 --> 00:24:10,040 THE IN VITRO DNT TESTING HAS 579 00:24:10,040 --> 00:24:12,200 BEEN USED IN A WEIGHT OF 580 00:24:12,200 --> 00:24:14,400 EVIDENCE ANALYSIS TO SUPPORT THE 581 00:24:14,400 --> 00:24:15,800 NEED FOR ADDITIONAL DNT DATA. 582 00:24:15,800 --> 00:24:20,800 SO I THINK AT A PREVIOUS MEETING 583 00:24:20,800 --> 00:24:22,120 WE'VE PROVIDED UPDATES FOR 584 00:24:22,120 --> 00:24:25,280 PUBLICATION AND WHERE WE UTILIZE 585 00:24:25,280 --> 00:24:28,800 DATA TO WAIVE THE NEED FOR 586 00:24:28,800 --> 00:24:29,880 ADDITIONAL DNT INFORMATION, WE 587 00:24:29,880 --> 00:24:31,880 HAVE SORT OF THE OPPOSITE HERE 588 00:24:31,880 --> 00:24:33,960 WHERE THE INFORMATION SUPPORTED 589 00:24:33,960 --> 00:24:36,200 A CONTINUED NEED TO SEARCH FOR 590 00:24:36,200 --> 00:24:40,200 MORE INFORMATION TO INFORM OUR 591 00:24:40,200 --> 00:24:42,840 DECISION MAKING. 592 00:24:42,840 --> 00:24:44,920 WE ALSO HAVE A LOT OF WORK GOING 593 00:24:44,920 --> 00:24:49,360 ON IN THE NAMs SPACE IN TERMS 594 00:24:49,360 --> 00:24:56,200 OF THE ENDOCRINE DISRUPTION. 595 00:24:56,200 --> 00:25:03,080 JANUARY 2023 RELEASED A WHITE 596 00:25:03,080 --> 00:25:04,400 PAPER EDSP. 597 00:25:04,400 --> 00:25:07,560 TWO MODELS, E.R. MODEL IS 18 598 00:25:07,560 --> 00:25:12,320 ASSAYS, AND A.R. MODEL MADE UP 599 00:25:12,320 --> 00:25:14,600 OF 11 ASSAYS, THESE ARE 600 00:25:14,600 --> 00:25:15,360 BASICALLY WE'RE SAYING THAT 601 00:25:15,360 --> 00:25:16,680 THESE HAVE THE POTENTIAL TO BE 602 00:25:16,680 --> 00:25:20,760 USED AS ALTERNATIVES FOR ASSAYS 603 00:25:20,760 --> 00:25:24,480 IN THE TIER 1 BATTERY. 604 00:25:24,480 --> 00:25:25,880 THERE'S ADDITIONAL MODELS NOTED 605 00:25:25,880 --> 00:25:28,360 IN THE DOCUMENT FOR PRIORITY 606 00:25:28,360 --> 00:25:30,800 SETTING, OR THAT COULD BE 607 00:25:30,800 --> 00:25:32,400 UTILIZED AS OTHER SCIENTIFICALLY 608 00:25:32,400 --> 00:25:34,760 RELEVANT INFORMATION FOR WEIGHT 609 00:25:34,760 --> 00:25:36,280 OF EVIDENCE. 610 00:25:36,280 --> 00:25:38,400 AND THEN I DON'T THINK -- I 611 00:25:38,400 --> 00:25:39,800 WOULD NEED ANOTHER PRESENTATION 612 00:25:39,800 --> 00:25:42,520 TO TALK ABOUT ONGOING RESEARCH 613 00:25:42,520 --> 00:25:46,480 OUR COLLEAGUES IN ORD ARE ALSO 614 00:25:46,480 --> 00:25:48,240 TAKING PART IN. 615 00:25:48,240 --> 00:25:50,200 IF YOU FOLLOWED THE STRAP 616 00:25:50,200 --> 00:25:53,320 PLANNING AT ORD ENDOCRINE 617 00:25:53,320 --> 00:25:55,480 DISRUPTION IS ONE OF THE BIGGEST 618 00:25:55,480 --> 00:25:56,840 PIECES AS WELL AS NAMs, 619 00:25:56,840 --> 00:25:59,960 TOGETHER THERE'S A LOT OF WORK 620 00:25:59,960 --> 00:26:01,600 INNING THERE. 621 00:26:01,600 --> 00:26:02,480 ANOTHER INITIATIVE THAT WE'RE 622 00:26:02,480 --> 00:26:07,160 SEEING KIND OF GET OFF THE 623 00:26:07,160 --> 00:26:09,440 GROUND IN OPP IS THE REDUCTION 624 00:26:09,440 --> 00:26:12,760 OF DOG STUDIES, TRYING TO LOOK 625 00:26:12,760 --> 00:26:19,520 AT POTENTIAL TO REDUCE OUR 626 00:26:19,520 --> 00:26:21,840 POSSIBLY ELIMINATE USE OF DOG 627 00:26:21,840 --> 00:26:23,920 STUDIES TO SUPPORT REGULATORY 628 00:26:23,920 --> 00:26:24,280 DECISIONS. 629 00:26:24,280 --> 00:26:25,600 IN 2021 TOOK PART IN 630 00:26:25,600 --> 00:26:29,920 COORDINATING WITH THE CENTER FOR 631 00:26:29,920 --> 00:26:30,920 ALTERNATIVE TO ANIMAL TESTING, 632 00:26:30,920 --> 00:26:32,760 WITH WORKSHOP ON CHALLENGES AND 633 00:26:32,760 --> 00:26:35,040 OPPORTUNITIES FOR OVERCOMING DOG 634 00:26:35,040 --> 00:26:37,880 USE FOR PESTICIDE EVALUATION AND 635 00:26:37,880 --> 00:26:38,440 REGISTRATION. 636 00:26:38,440 --> 00:26:41,320 THAT HAS LED TO OUR COORDINATING 637 00:26:41,320 --> 00:26:43,840 EFFORTS THROUGH THE HEALTH AND 638 00:26:43,840 --> 00:26:47,200 ENVIRONMENTAL SCIENCES 639 00:26:47,200 --> 00:26:47,480 INSTITUTE. 640 00:26:47,480 --> 00:26:50,600 WE SET UP A WORK THROUGH TO WORK 641 00:26:50,600 --> 00:26:51,480 THROUGH RETROSPECTIVE ANALYSES 642 00:26:51,480 --> 00:26:54,080 TO SEE ARE THERE PARTICULAR 643 00:26:54,080 --> 00:26:54,960 CHEMICAL GROUPS THAT RELY WHERE 644 00:26:54,960 --> 00:26:57,800 THE DOG IS THE MOST SENSITIVE 645 00:26:57,800 --> 00:27:00,680 AND WE STILL REALLY NEED DOG 646 00:27:00,680 --> 00:27:05,040 STUDIES TO INFORM THERE UNTIL WE 647 00:27:05,040 --> 00:27:06,360 CAN DEVELOP ALTERNATIVE METHODS, 648 00:27:06,360 --> 00:27:08,120 ARE WE ESSENTIALLY BARELY USING 649 00:27:08,120 --> 00:27:09,680 THE DOG STUDY, SO TRYING TO GET 650 00:27:09,680 --> 00:27:11,480 A GOOD GRASP ON THE IMPACT OF 651 00:27:11,480 --> 00:27:14,760 THE DOG STUDIES FOR OUR 652 00:27:14,760 --> 00:27:17,080 EVALUATIONS, AND THEN WORKING 653 00:27:17,080 --> 00:27:18,520 THROUGH THAT, YOU KNOW, THROUGH 654 00:27:18,520 --> 00:27:20,360 THE RESULTS OF THOSE ANALYSES TO 655 00:27:20,360 --> 00:27:22,320 FIGURE OUT WHAT OUR NEXT STEPS 656 00:27:22,320 --> 00:27:23,200 WILL BE. 657 00:27:23,200 --> 00:27:24,720 BUT THAT DOESN'T MEAN WE'RE ONLY 658 00:27:24,720 --> 00:27:26,280 FOCUSED ON THAT. 659 00:27:26,280 --> 00:27:29,120 WE'RE ALSO LOOKING AT POTENTIAL 660 00:27:29,120 --> 00:27:31,520 TO USE KINETIC DATA AND 661 00:27:31,520 --> 00:27:32,560 COMPARATIVE METABOLISM DATA AND 662 00:27:32,560 --> 00:27:36,120 OTHER IN VITRO DATA TO TRY TO -- 663 00:27:36,120 --> 00:27:39,400 COULD WE DEVELOP A FRAMEWORK OR 664 00:27:39,400 --> 00:27:40,400 FLOWCHART HOW YOU GET TO THE 665 00:27:40,400 --> 00:27:43,640 POINT WHERE YOU DO OR DO NOT 666 00:27:43,640 --> 00:27:47,440 NEED TO UTILIZE THE DOG STUDIES 667 00:27:47,440 --> 00:27:53,400 IN OUR DECISION MAKING. 668 00:27:53,400 --> 00:27:56,480 THROUGHOUT THE YEARS WE'VE GIVEN 669 00:27:56,480 --> 00:27:59,640 UPDATES ON WORK ON EYE 670 00:27:59,640 --> 00:28:02,720 IRRITATION FOR OUR COLLEAGUES IN 671 00:28:02,720 --> 00:28:04,320 ANTIMICROBIAL DIVISION, WE HAVE 672 00:28:04,320 --> 00:28:07,200 A POLICY FOR ACCEPTING EYE 673 00:28:07,200 --> 00:28:07,840 IRRITATION ASSAYS FOR 674 00:28:07,840 --> 00:28:10,560 ANTIMICROBIAL CLEANING PRODUCTS. 675 00:28:10,560 --> 00:28:13,560 WE'VE DONE PERSPECTIVE AND 676 00:28:13,560 --> 00:28:15,400 RETROSPECTIVE EVALUATIONS WITH 677 00:28:15,400 --> 00:28:15,560 NIH. 678 00:28:15,560 --> 00:28:17,800 THERE'S A PRETTY RECENT 679 00:28:17,800 --> 00:28:20,440 MANUSCRIPT THAT WAS A 680 00:28:20,440 --> 00:28:21,320 COLLABORATION WITH PETA AND 681 00:28:21,320 --> 00:28:22,720 OTHERS TO LOOK AT HUMAN 682 00:28:22,720 --> 00:28:23,840 RELEVANCE AND STRENGTHS AND 683 00:28:23,840 --> 00:28:24,960 UNCERTAINTIES OF THE DIFFERENT 684 00:28:24,960 --> 00:28:28,280 EYE IRRITATION ASSAYS THAT ARE 685 00:28:28,280 --> 00:28:29,840 OUT THERE. 686 00:28:29,840 --> 00:28:31,280 AND MORE RECENT TIME WE HAVE 687 00:28:31,280 --> 00:28:38,040 STAFF THAT HAVE BEEN WORKING 688 00:28:38,040 --> 00:28:44,800 WITH NICEATM AND PETA AND IIVS, 689 00:28:44,800 --> 00:28:46,400 AND THAT MANUSCRIPT IS ALMOST TO 690 00:28:46,400 --> 00:28:48,520 THE FINISH LINE SO HOPEFULLY 691 00:28:48,520 --> 00:28:50,400 LATER THIS YEAR IT WILL BE OUT 692 00:28:50,400 --> 00:28:52,200 IN THE PUBLIC AND YOU GUYS WILL 693 00:28:52,200 --> 00:28:56,240 BE SEEING THAT AS WELL. 694 00:28:56,240 --> 00:29:00,400 AND I ALSO WANTED TO MENTION ONE 695 00:29:00,400 --> 00:29:01,400 ADDITIONAL PUBLICATION THAT I 696 00:29:01,400 --> 00:29:04,040 FEEL LIKE WENT UNDER THE RADAR 697 00:29:04,040 --> 00:29:08,080 LAST YEAR BUT I THINK THIS IS A 698 00:29:08,080 --> 00:29:09,600 GREAT RESOURCE. 699 00:29:09,600 --> 00:29:12,040 THIS DOCUMENT -- THIS 700 00:29:12,040 --> 00:29:13,880 PUBLICATION WAS A COLLABORATION 701 00:29:13,880 --> 00:29:16,600 ACROSS DIFFERENT JURISDICTIONS 702 00:29:16,600 --> 00:29:18,800 TO TALK ABOUT HOW CAN NAMs BE 703 00:29:18,800 --> 00:29:20,200 USED, WHAT'S THE REGULATORY 704 00:29:20,200 --> 00:29:21,840 FLEXIBILITY, WHAT ARE SOME 705 00:29:21,840 --> 00:29:23,000 EXAMPLES OF THAT. 706 00:29:23,000 --> 00:29:24,200 SO IT'S LOOKING AT CANADA AND 707 00:29:24,200 --> 00:29:28,440 EUROPE AND THE U.S., LOOKING AT 708 00:29:28,440 --> 00:29:29,640 INDUSTRIAL CHEMICALS AND 709 00:29:29,640 --> 00:29:31,920 PESTICIDES, SO I THINK I JUST 710 00:29:31,920 --> 00:29:32,920 WANTED TO REALLY HIGHLIGHT THAT 711 00:29:32,920 --> 00:29:34,760 I THINK THIS DOCUMENT IS A GREAT 712 00:29:34,760 --> 00:29:36,080 RESOURCE FOR SOMEBODY TRYING TO 713 00:29:36,080 --> 00:29:37,640 GET A HANDLE ON HOW NAMs ARE 714 00:29:37,640 --> 00:29:40,800 BEING USED IN A REGULATORY 715 00:29:40,800 --> 00:29:41,480 CONTEXT ACROSS DIFFERENT 716 00:29:41,480 --> 00:29:44,000 JURISDICTIONS. 717 00:29:44,000 --> 00:29:45,840 718 00:29:45,840 --> 00:29:48,680 AND TYPICALLY MOST OF WHAT WE 719 00:29:48,680 --> 00:29:49,960 DISCUSS WITH OPP IS HUMAN HEALTH 720 00:29:49,960 --> 00:29:52,680 BUT WE DID HAVE SOME PROJECTS 721 00:29:52,680 --> 00:29:58,080 ONGOING IN THE ECO-TOX REALM. 722 00:29:58,080 --> 00:30:01,440 THE RETROSPECTIVE ANALYSES OF 723 00:30:01,440 --> 00:30:02,880 CONTINUED, FISH ACUTE 724 00:30:02,880 --> 00:30:04,000 RETROSPECTIVE I TALKED ABOUT 725 00:30:04,000 --> 00:30:08,240 BEFORE WHERE WE REQUIRE THREE 726 00:30:08,240 --> 00:30:09,280 DIFFERENT FISH STUDIES BUT COULD 727 00:30:09,280 --> 00:30:11,640 WE REDUCE THAT DOWN TO TWO OR 728 00:30:11,640 --> 00:30:14,600 POSSIBLY ONE, AND ACTUALLY 729 00:30:14,600 --> 00:30:15,520 RECENTLY WE PUBLISHED A 730 00:30:15,520 --> 00:30:21,400 MANUSCRIPT OF THE RETROSPECTIVE 731 00:30:21,400 --> 00:30:22,760 ANALYSIS, THERE'S PROMISE TO 732 00:30:22,760 --> 00:30:27,120 REDUCE THE NUMBER OF ANIMALS AND 733 00:30:27,120 --> 00:30:28,200 INTERNALLY TRYING TO FIGURE OUT, 734 00:30:28,200 --> 00:30:32,840 YOU KNOW, WILL THIS TURN INTO A 735 00:30:32,840 --> 00:30:34,440 GUIDANCE TOWARDS -- WILL THIS 736 00:30:34,440 --> 00:30:36,080 INFORMATION BE USED TO 737 00:30:36,080 --> 00:30:37,200 ULTIMATELY PROVIDE GUIDANCE HOW 738 00:30:37,200 --> 00:30:39,840 WE CAN REDUCE THOSE STUDIES 739 00:30:39,840 --> 00:30:42,760 BEFORE REGISTRANTS GO OUT AND 740 00:30:42,760 --> 00:30:43,200 CONDUCT THEM. 741 00:30:43,200 --> 00:30:44,080 AND ADDITIONALLY WE'RE 742 00:30:44,080 --> 00:30:49,480 CONTINUING OUR WORK ON THE AVIAN 743 00:30:49,480 --> 00:30:50,320 REPRODUCTIVE RETROSPECTIVE, WE 744 00:30:50,320 --> 00:30:54,160 CURRENTLY REQUIRE TWO BUT ARE 745 00:30:54,160 --> 00:30:56,040 TWO SPECIES NEED AND WE'RE STILL 746 00:30:56,040 --> 00:30:59,120 IN THE DATA CURATION AND 747 00:30:59,120 --> 00:31:00,280 EXPLANATION, STILL CHUGGING 748 00:31:00,280 --> 00:31:01,400 ALONG. 749 00:31:01,400 --> 00:31:05,240 AND THEN JUST BRIEFLY, WE'RE 750 00:31:05,240 --> 00:31:15,240 CONTINUING OUR WORK WITH NICEM 751 00:31:15,240 --> 00:31:18,080 AND OTHERS. 752 00:31:18,080 --> 00:31:19,840 WE HAVE MODELING WORK FOR 753 00:31:19,840 --> 00:31:27,720 ECOSAR, YOU'LL HEAR ABOUT THAT 754 00:31:27,720 --> 00:31:28,800 IN THE NEXT PRESENTATION, A LOT 755 00:31:28,800 --> 00:31:31,000 OF WORK IN THE ECO-TOX BASE, A 756 00:31:31,000 --> 00:31:33,960 LOT OF DIFFERENT EFFORTS GOING. 757 00:31:33,960 --> 00:31:35,600 AND LASTLY, JUST WANTED TO 758 00:31:35,600 --> 00:31:36,640 MENTION OUR WEBSITE. 759 00:31:36,640 --> 00:31:40,120 I DIDN'T INCLUDE A LINK TO CLICK 760 00:31:40,120 --> 00:31:42,640 ON, DON'T WORRY. 761 00:31:42,640 --> 00:31:45,280 BUT WE CONTINUE TO UPDATE THIS. 762 00:31:45,280 --> 00:31:47,320 WE'RE IN THE PROCESS RIGHT NOW 763 00:31:47,320 --> 00:31:49,320 OF LOOKING AT WHAT NEEDS TO GET 764 00:31:49,320 --> 00:31:51,280 UPDATED FOR THIS YEAR, ADDING 765 00:31:51,280 --> 00:31:52,280 OUR METRICS, SO ON THE 766 00:31:52,280 --> 00:31:53,920 RIGHT-HAND SIDE YOU CAN SEE WE 767 00:31:53,920 --> 00:31:55,880 HAVE A METRICS PAGE, STRATEGIES 768 00:31:55,880 --> 00:31:57,400 TO REDUCE ANIMAL TESTING AND 769 00:31:57,400 --> 00:31:58,760 STRATEGIES TO REPLACE ANIMAL 770 00:31:58,760 --> 00:32:00,160 TESTING, SO WE'RE TRYING OUR 771 00:32:00,160 --> 00:32:02,880 BEST TO KEEP THAT UP TO DATE. 772 00:32:02,880 --> 00:32:04,320 WE'RE LATER THAN USUAL THIS YEAR 773 00:32:04,320 --> 00:32:06,760 BUT WE SHOULD BE SEEING SOME 774 00:32:06,760 --> 00:32:11,120 UPDATES FOR LATER THIS YEAR. 775 00:32:11,120 --> 00:32:11,800 I THINK THAT'S IT. 776 00:32:11,800 --> 00:32:14,040 [APPLAUSE] 777 00:32:14,040 --> 00:32:18,880 778 00:32:18,880 --> 00:32:21,280 >> DO WE HAVE ANY QUESTIONS IN 779 00:32:21,280 --> 00:32:24,280 THE ROOM FOR MONIQUE? 780 00:32:24,280 --> 00:32:30,400 781 00:32:30,400 --> 00:32:30,720 OKAY. 782 00:32:30,720 --> 00:32:35,120 ONE QUESTION. 783 00:32:35,120 --> 00:32:36,680 >> QUICK QUESTION. 784 00:32:36,680 --> 00:32:38,040 SO THANKS, MONIQUE, ALWAYS LOTS 785 00:32:38,040 --> 00:32:41,120 OF EXCITING THINGS IN YOUR 786 00:32:41,120 --> 00:32:41,440 PRESENTATIONS. 787 00:32:41,440 --> 00:32:43,600 YOU MENTIONED ACUTE FISH 788 00:32:43,600 --> 00:32:47,120 TOXICITY DECIDING WHAT TO DO 789 00:32:47,120 --> 00:32:47,560 AND 790 00:32:47,560 --> 00:32:49,640 WHERE THAT GOES TOWARDS 791 00:32:49,640 --> 00:32:51,040 GUIDANCE, A COUPLE THINGS OPP 792 00:32:51,040 --> 00:32:54,200 HAS MADE GREAT ACTIVITY ON, 793 00:32:54,200 --> 00:32:56,320 DERMAL PENETRATION, ET CETERA. 794 00:32:56,320 --> 00:32:57,520 ARE THERE PLANS TO MOVE THOSE 795 00:32:57,520 --> 00:32:59,600 AND THINGS COMING IN THE FUTURE 796 00:32:59,600 --> 00:33:02,000 LIKE EYE TESTING TOWARDS 797 00:33:02,000 --> 00:33:04,320 GUIDANCE POLICIES, ET CETERA? 798 00:33:04,320 --> 00:33:05,840 >> YEAH, WE'VE BEEN HAVING 799 00:33:05,840 --> 00:33:08,440 INTERNAL CONVERSATIONS ON THAT 800 00:33:08,440 --> 00:33:09,560 BECAUSE THERE'S BEEN 801 00:33:09,560 --> 00:33:11,840 DIFFICULTIES IN THE AGENCY OF 802 00:33:11,840 --> 00:33:14,600 MOVING GUIDANCE AND POLICY 803 00:33:14,600 --> 00:33:16,000 DOCUMENTS ALONG, AND SO WE 804 00:33:16,000 --> 00:33:18,400 WANTED TO MAKE SURE WE'RE 805 00:33:18,400 --> 00:33:20,160 UTILIZING RESOURCES IN A SMART 806 00:33:20,160 --> 00:33:22,360 WAY, ALSO BEING SUCCESSFUL IN 807 00:33:22,360 --> 00:33:23,440 GETTING GUIDANCE DOCUMENTS OR 808 00:33:23,440 --> 00:33:24,840 POLICY DOCUMENTS OUT THERE SO 809 00:33:24,840 --> 00:33:29,680 THERE HAVE BEEN INTERNAL 810 00:33:29,680 --> 00:33:31,960 CONVERSATIONS WHAT TO FOCUS ON 811 00:33:31,960 --> 00:33:35,480 AND HOW TO IMPROVE THAT PROCESS 812 00:33:35,480 --> 00:33:36,320 BUT THERE'S STILL WORK THAT 813 00:33:36,320 --> 00:33:38,760 NEEDS TO GET DONE THERE TO GET 814 00:33:38,760 --> 00:33:39,400 THERE. 815 00:33:39,400 --> 00:33:40,600 BUT, YEAH, I THINK IT IS 816 00:33:40,600 --> 00:33:43,000 IMPORTANT TO HAVE THOSE 817 00:33:43,000 --> 00:33:45,840 DOCUMENTS SO THAT STAKEHOLDERS, 818 00:33:45,840 --> 00:33:47,760 YOU KNOW, ARE MORE -- THERE'S 819 00:33:47,760 --> 00:33:49,200 MORE CLARITY TO STAKE HOLDERS 820 00:33:49,200 --> 00:33:50,560 WHAT WE'RE WILLING TO DO AND HOW 821 00:33:50,560 --> 00:33:52,640 WE'RE DOING IT BUT ALSO 822 00:33:52,640 --> 00:33:53,960 INTERNALLY FOR OUR STAFF, ALSO 823 00:33:53,960 --> 00:33:55,600 HELPS, YOU KNOW, FOR THEM TO 824 00:33:55,600 --> 00:33:57,000 KNOW WHAT WE'RE DOING AND WHAT 825 00:33:57,000 --> 00:33:58,880 WE ACCEPT AND ALL OF THAT STUFF. 826 00:33:58,880 --> 00:34:00,440 SO I THINK IT'S SOMETHING THAT 827 00:34:00,440 --> 00:34:02,840 WE NEED TO WORK ON THOUGH. 828 00:34:02,840 --> 00:34:05,480 THANKS. 829 00:34:05,480 --> 00:34:07,960 >> OKAY. 830 00:34:07,960 --> 00:34:08,160 GREAT. 831 00:34:08,160 --> 00:34:09,320 AND NEXT PRESENTER, LAST 832 00:34:09,320 --> 00:34:12,680 PRESENTER OF THE MORNING SESSION 833 00:34:12,680 --> 00:34:20,080 BEFORE A BREAK IS ANNA LOWIT, 834 00:34:20,080 --> 00:34:21,080 UPDATE FROM OPPT. 835 00:34:21,080 --> 00:34:21,840 >> HI, EVERYBODY. 836 00:34:21,840 --> 00:34:23,960 SO I'M GOING TO WATCH MY CLOCK 837 00:34:23,960 --> 00:34:26,880 BECAUSE SOME OF YOU KNOW ONCE I 838 00:34:26,880 --> 00:34:28,440 GET STARTED SOMETIMES I TEND TO 839 00:34:28,440 --> 00:34:29,320 RUN OVER. 840 00:34:29,320 --> 00:34:32,480 HOPEFULLY I CAN GET US CLOSE TO 841 00:34:32,480 --> 00:34:34,560 BACK TO WHERE WE ARE SUPPOSED TO 842 00:34:34,560 --> 00:34:35,320 BE. 843 00:34:35,320 --> 00:34:39,320 I GUESS I USE THIS TO FOR WASHED 844 00:34:39,320 --> 00:34:42,480 THE SLIDES. 845 00:34:42,480 --> 00:34:43,640 GOT IT. 846 00:34:43,640 --> 00:34:43,960 OKAY. 847 00:34:43,960 --> 00:34:46,960 SO I'M GOING TO SHOW THE 848 00:34:46,960 --> 00:34:48,040 DISCLAIMER BECAUSE OUR VIEWS ARE 849 00:34:48,040 --> 00:34:55,400 THOSE OF MY OWN AND NOT OF MY 850 00:34:55,400 --> 00:34:55,600 AGENCY. 851 00:34:55,600 --> 00:34:56,600 OKAY. 852 00:34:56,600 --> 00:34:59,680 SO, A FEW UPDATES, I'M GOING TO 853 00:34:59,680 --> 00:35:03,280 DO A WHIRLWIND LIKE MONIQUE HAS. 854 00:35:03,280 --> 00:35:04,400 I'VE BEEN WITH THE PROGRAM A 855 00:35:04,400 --> 00:35:07,880 LITTLE BIT OVER A YEAR, YOU'LL 856 00:35:07,880 --> 00:35:10,200 SEE THAT ONE OF MY FIRST 857 00:35:10,200 --> 00:35:11,280 ACTIVITIES, ONE OF MY PRIORITIES 858 00:35:11,280 --> 00:35:15,200 WHEN I MOVED OVER IN THE NAMs 859 00:35:15,200 --> 00:35:19,840 SPACE WAS TO BEGIN TO BUILD 860 00:35:19,840 --> 00:35:21,160 THOSE COLLABORATIONS AND THOSE 861 00:35:21,160 --> 00:35:21,920 IMPORTANT CONNECTIONS NOT ONLY 862 00:35:21,920 --> 00:35:23,680 WITH THE OFFICE OF RESEARCH AND 863 00:35:23,680 --> 00:35:25,160 DEVELOPMENT BUT WITH OUR 864 00:35:25,160 --> 00:35:25,800 EXTERNAL COLLABORATORS, SOME OF 865 00:35:25,800 --> 00:35:29,440 WHOM ARE HERE IN THE ROOM, MANY 866 00:35:29,440 --> 00:35:29,720 ONLINE. 867 00:35:29,720 --> 00:35:32,200 AND AS WE KNOW, IT'S BEEN THOSE 868 00:35:32,200 --> 00:35:32,960 COLLABORATIONS AND THOSE 869 00:35:32,960 --> 00:35:34,480 ENGAGEMENTS THAT HAVE REALLY 870 00:35:34,480 --> 00:35:36,640 ADVANCED THE PESTICIDE PROGRAM 871 00:35:36,640 --> 00:35:36,880 RAPIDLY. 872 00:35:36,880 --> 00:35:39,080 A LOT OF THAT YOU SAW IN 873 00:35:39,080 --> 00:35:39,880 MONIQUE'S PRESENTATION, THAT 874 00:35:39,880 --> 00:35:41,280 WE'VE BEEN TALKING ABOUT FOR A 875 00:35:41,280 --> 00:35:42,800 LONG TIME, AND OTHER THINGS THAT 876 00:35:42,800 --> 00:35:45,080 AREN'T TALKED ABOUT TODAY. 877 00:35:45,080 --> 00:35:46,960 AND SO WE'RE STARTING TO SEE 878 00:35:46,960 --> 00:35:50,040 REALLY THE FRUITS OF THOSE 879 00:35:50,040 --> 00:35:51,560 ENGAGEMENTS, AND REALLY STARTING 880 00:35:51,560 --> 00:35:53,560 TO SEE SOME ACCELERATION IN THE 881 00:35:53,560 --> 00:35:54,960 TOXICS PROGRAM. 882 00:35:54,960 --> 00:35:56,160 THAT'S EXCITING. 883 00:35:56,160 --> 00:35:58,480 ONE OF THOSE IS REALLY ONGOING 884 00:35:58,480 --> 00:36:02,520 RESEARCH PROGRAM TO SUPPORT THE 885 00:36:02,520 --> 00:36:04,800 NEW CHEMICALS PROGRAM, UNDER 886 00:36:04,800 --> 00:36:05,120 TSCA. 887 00:36:05,120 --> 00:36:08,200 TSCA IS SPLIT BETWEEN EXISTING 888 00:36:08,200 --> 00:36:10,160 CHEMICALS AND NEW CHEMICALS, SO 889 00:36:10,160 --> 00:36:12,280 OPPT IS THE GATE KEEPER TO NEW 890 00:36:12,280 --> 00:36:14,080 CHEMICALS IN THE MARKET FOR 891 00:36:14,080 --> 00:36:15,080 INNOVATION SO THINGS IN YOUR -- 892 00:36:15,080 --> 00:36:16,640 YOU KNOW, THINGS YOU CARRY 893 00:36:16,640 --> 00:36:19,480 AROUND IN YOUR CAR, YOUR PHONE, 894 00:36:19,480 --> 00:36:20,920 ET CETERA. 895 00:36:20,920 --> 00:36:22,760 ALL THOSE CHEMISTRIES GO THROUGH 896 00:36:22,760 --> 00:36:24,080 THE NEW CHEMICALS PROGRAM. 897 00:36:24,080 --> 00:36:26,480 A LOT OF METHODS HAVE BEEN USING 898 00:36:26,480 --> 00:36:28,760 FOR A VERY LONG TIME, UNIQUE 899 00:36:28,760 --> 00:36:31,280 PROGRAM BECAUSE THEY ONLY HAVE 900 00:36:31,280 --> 00:36:34,200 EITHER 30 OR 90 DAYS TO EVALUATE 901 00:36:34,200 --> 00:36:35,640 NEW CHEMICALS BEFORE THEY ARE 902 00:36:35,640 --> 00:36:36,600 APPROVED FOR MARKET. 903 00:36:36,600 --> 00:36:37,840 SO A LOT OF METHODS THEY HAVE 904 00:36:37,840 --> 00:36:39,280 BEEN USING ARE THE SAME AS THEY 905 00:36:39,280 --> 00:36:41,440 HAVE BEEN DOING FOR A LONG TIME. 906 00:36:41,440 --> 00:36:45,520 LAST YEAR WE INITIATED A 907 00:36:45,520 --> 00:36:47,600 COLLABORATIVE RESEARCH ACTIVITY, 908 00:36:47,600 --> 00:36:49,280 OFTEN CALLED NCCRP, NEW 909 00:36:49,280 --> 00:36:50,240 CHEMICALS COLLABORATIVE RESEARCH 910 00:36:50,240 --> 00:36:50,880 PROGRAM. 911 00:36:50,880 --> 00:36:56,120 SO FAR WE'VE BEEN WORKING WITH 912 00:36:56,120 --> 00:36:57,240 OFFICE OF RESEARCH AND 913 00:36:57,240 --> 00:36:59,400 DEVELOPMENT, UPDATED LAST YEAR. 914 00:36:59,400 --> 00:37:02,360 THE COMING YEAR WILL BE ACTIVELY 915 00:37:02,360 --> 00:37:03,240 WORKING WITH EXTERNAL 916 00:37:03,240 --> 00:37:04,440 STAKEHOLDERS AND OTHER FEDERAL 917 00:37:04,440 --> 00:37:06,320 PARTNERS TO HELP ADD TO THAT 918 00:37:06,320 --> 00:37:08,280 PROGRAM AND FILL IN SOME OF THE 919 00:37:08,280 --> 00:37:09,400 RESEARCH GAPS. 920 00:37:09,400 --> 00:37:11,000 THIS YEAR'S UPDATE IS REALLY 921 00:37:11,000 --> 00:37:12,920 ABOUT THE FINALIZATION OF THAT 922 00:37:12,920 --> 00:37:14,840 PROPOSAL, AND SO YOU CAN SEE 923 00:37:14,840 --> 00:37:20,760 OCTOBER OF 22 THAT DOCUMENT WAS 924 00:37:20,760 --> 00:37:25,560 FINALIZED, REVISED BY FEDERAL 925 00:37:25,560 --> 00:37:28,000 COMMITTEE, BOSC, ALSO NOW 926 00:37:28,000 --> 00:37:28,440 AVAILABLE. 927 00:37:28,440 --> 00:37:30,320 THE BOSC PROVIDED IMPORTANT 928 00:37:30,320 --> 00:37:31,320 RECOMMENDATIONS BUT REALLY 929 00:37:31,320 --> 00:37:35,360 DIDN'T FOUNDATIONALLY CHANGE THE 930 00:37:35,360 --> 00:37:35,880 DIRECTION OF THE PROGRAM. 931 00:37:35,880 --> 00:37:38,720 ONE OF THE NEW THINGS IN THE 932 00:37:38,720 --> 00:37:41,800 TSCA PROGRAM IN THE LAST YEAR IS 933 00:37:41,800 --> 00:37:52,320 A COLLABORATIVE EFFORT TO BRING 934 00:37:52,320 --> 00:37:53,400 IN THE GUIDELINES, I DON'T 935 00:37:53,400 --> 00:37:55,560 EXPECT ANYBODY TO READ THE TINY 936 00:37:55,560 --> 00:37:58,800 PRINT BUT SAFE TO SAY THERE'S A 937 00:37:58,800 --> 00:38:00,400 DECISION FRAMEWORK DEVELOPED 938 00:38:00,400 --> 00:38:01,640 WITH COLLABORATORS AND OUR STAFF 939 00:38:01,640 --> 00:38:04,040 AT THE NEW CHEMICALS PROGRAM, TO 940 00:38:04,040 --> 00:38:07,120 BEGIN TO BRING IN MORE FULLY EYE 941 00:38:07,120 --> 00:38:14,600 IRRITATION ASSAYS IN HAZARD 942 00:38:14,600 --> 00:38:17,520 CALLS FOR NEW CHEMICALS. 943 00:38:17,520 --> 00:38:19,600 THIS IS EXTRACTED FROM A POSTER 944 00:38:19,600 --> 00:38:21,440 PRESENTED IN MARCH ARE FOR SOT 945 00:38:21,440 --> 00:38:22,640 MEMBERS YOU CAN STILL FIND THAT 946 00:38:22,640 --> 00:38:25,480 I BELIEVE ON THE WEBSITE AND GET 947 00:38:25,480 --> 00:38:26,480 THE DETAILS. 948 00:38:26,480 --> 00:38:32,920 BUT WE'RE ALSO WORKING ON 949 00:38:32,920 --> 00:38:36,880 SIMILAR FOR EYE IRRITATION AND 950 00:38:36,880 --> 00:38:39,360 SKIN SENSITIZATION FOR HAZARD 951 00:38:39,360 --> 00:38:41,160 CALLS AND QUANTITATIVE 952 00:38:41,160 --> 00:38:43,320 ASSESSMENT FOR SKIN SENSITIZERS. 953 00:38:43,320 --> 00:38:44,520 WHAT'S IMPORTANT HERE, AND WHAT 954 00:38:44,520 --> 00:38:49,480 MAKES IT UNIQUE I THINK IS THIS 955 00:38:49,480 --> 00:38:52,200 FRAMEWORK PRIORITIZES THE USE OF 956 00:38:52,200 --> 00:38:55,240 IN VITRO STUDIES FROM HUMAN DATA 957 00:38:55,240 --> 00:38:59,520 OVER THAT OF ANIMAL MODELS. 958 00:38:59,520 --> 00:39:01,480 ANOTHER BRAND NEW ACTIVITY 959 00:39:01,480 --> 00:39:04,120 THAT'S A COLLABORATION BETWEEN 960 00:39:04,120 --> 00:39:09,600 OPPT AND MANY OTHER STAKEHOLDERS 961 00:39:09,600 --> 00:39:16,720 WORLDWIDE IS THE WORK IN 962 00:39:16,720 --> 00:39:19,000 SENSITIZATION, PROPOSAL OF 963 00:39:19,000 --> 00:39:21,200 PROJECT FOR DETAILED -- TRYING 964 00:39:21,200 --> 00:39:24,160 TO NOT USE ACRONYMS, DETAILED 965 00:39:24,160 --> 00:39:26,880 REVIEW PAPER APPROVED LAST MONTH 966 00:39:26,880 --> 00:39:30,240 AT THE OECD. 967 00:39:30,240 --> 00:39:31,960 TOXIC SPACE, RESPIRATORY 968 00:39:31,960 --> 00:39:32,720 SENSITIZATION IS REALLY 969 00:39:32,720 --> 00:39:37,480 IMPORTANT ENDPOINT IN TERMS OF 970 00:39:37,480 --> 00:39:44,240 DETERMINING HAZARD AND NO 971 00:39:44,240 --> 00:39:45,520 HAZARD, KNOCK APPROVED, ENTIRELY 972 00:39:45,520 --> 00:39:46,880 BASED ON STRUCTURE. 973 00:39:46,880 --> 00:39:50,240 IT'S AN IMPORTANT AND REALLY 974 00:39:50,240 --> 00:39:51,680 POTENTIALLY FATAL ENDPOINT AND 975 00:39:51,680 --> 00:39:53,200 SERIOUS POISONING IMPACT SO 976 00:39:53,200 --> 00:39:55,520 WE'RE EXCITED ABOUT THE 977 00:39:55,520 --> 00:39:58,000 POTENTIAL IN THE NEXT FEW YEARS 978 00:39:58,000 --> 00:40:03,280 TO HAVE A NAMs-BASED APPROACH 979 00:40:03,280 --> 00:40:05,480 FOR RESPIRATORY SENSITIZATION. 980 00:40:05,480 --> 00:40:08,120 ONE OF THE AREAS THAT WE'VE BEEN 981 00:40:08,120 --> 00:40:10,520 WORKING CLOSELY WITH ORD ON, AS 982 00:40:10,520 --> 00:40:12,240 YOU HEARD FROM MONIQUE A FEW 983 00:40:12,240 --> 00:40:14,360 MINUTES AGO, THE OFFICE OF 984 00:40:14,360 --> 00:40:15,920 CHEMICAL SAFETY AND POLLUTION 985 00:40:15,920 --> 00:40:17,320 PREVENTION HAS BEEN EXCITED 986 00:40:17,320 --> 00:40:19,960 ABOUT THE DNT NAMs BATTERY FOR 987 00:40:19,960 --> 00:40:24,200 A LONG TIME, ACTIVELY ENGAGED IN 988 00:40:24,200 --> 00:40:25,320 ITS -- SINCE ITS BEGINNING 989 00:40:25,320 --> 00:40:27,160 ALMOST TEN YEARS AGO, AND WE'RE 990 00:40:27,160 --> 00:40:28,160 STARTING TO REALLY SEE THE 991 00:40:28,160 --> 00:40:31,080 FRUITS OF THAT NOT ONLY AT THE 992 00:40:31,080 --> 00:40:33,520 OECD, AT THE APPROVAL OF THAT 993 00:40:33,520 --> 00:40:36,360 GUIDANCE DOCUMENT, BUT ALSO THE 994 00:40:36,360 --> 00:40:41,360 ACCELERATION OF AVAILABLE DATA 995 00:40:41,360 --> 00:40:47,080 IN NAMs SPACE, A BRAND-NEW 996 00:40:47,080 --> 00:40:50,360 PUBLICATION OUT OF ORD LOOKING 997 00:40:50,360 --> 00:40:52,960 AT 16 PFAS FOR SCREENING IN THE 998 00:40:52,960 --> 00:40:54,640 DNT SPACE AND WE'VE ALSO 999 00:40:54,640 --> 00:40:55,960 PROPOSED A NUMBER OF CHEMICALS 1000 00:40:55,960 --> 00:40:59,920 TO BE TESTED BY THE NTP, 1001 00:40:59,920 --> 00:41:04,920 ADDITIONAL PFAS, ALSO SOME FIRE 1002 00:41:04,920 --> 00:41:06,360 RETARDANDS, EXCITED ABOUT 1003 00:41:06,360 --> 00:41:07,640 ACCELERATION OF AVAILABLE PFAS 1004 00:41:07,640 --> 00:41:08,840 INFORMATION TO HELP WITH 1005 00:41:08,840 --> 00:41:19,240 SCREENING AND NATIONAL 1006 00:41:21,840 --> 00:41:23,320 TESTING STRATEGY. 1007 00:41:23,320 --> 00:41:25,600 OPPT HAS BEEN A LEADER, AND ONE 1008 00:41:25,600 --> 00:41:28,120 THING WE'RE DOING IS UPDATING 1009 00:41:28,120 --> 00:41:29,960 THOSE AND BUILDING NEW TOOLS BUT 1010 00:41:29,960 --> 00:41:31,840 THERE ARE LONGSTANDING TOOLS 1011 00:41:31,840 --> 00:41:36,440 USED EVERY DAY, MANY PARTS OF 1012 00:41:36,440 --> 00:41:41,680 EPA USE ECOSAR FOR A VARIETY OF 1013 00:41:41,680 --> 00:41:42,880 THINGS, INCLUDING ACUTE 1014 00:41:42,880 --> 00:41:48,360 TOXICITY, IN PARTICULAR, AND 1015 00:41:48,360 --> 00:41:51,240 CHRONIC TOXICITY PARTICULARLY 1016 00:41:51,240 --> 00:41:55,920 FOR FISH AND DAPHNIDs, USING 1017 00:41:55,920 --> 00:41:58,760 ECOSAR FOR LOOKING EXPLICITLY AT 1018 00:41:58,760 --> 00:42:00,120 AQUATIC TOXICITY FOR NEW 1019 00:42:00,120 --> 00:42:02,760 CHEMICALS AND WEIGHT OF EVIDENCE 1020 00:42:02,760 --> 00:42:05,240 AND ANALOG SELECTION IN THE 1021 00:42:05,240 --> 00:42:07,000 EXISTING CHEMICALS PROCESS 1022 00:42:07,000 --> 00:42:08,200 LOOKING FORWARD TO UPDATES OVER 1023 00:42:08,200 --> 00:42:10,720 THE NEXT YEAR OR SO. 1024 00:42:10,720 --> 00:42:18,800 NOT ONLY FOR ECOSAR BUT MANY 1025 00:42:18,800 --> 00:42:20,480 QSARs BEING UPDATED. 1026 00:42:20,480 --> 00:42:25,160 NEW CHEMICALS PROGRAM IS A HEAVY 1027 00:42:25,160 --> 00:42:28,000 USER OF THE TOOLBOX, ACTIVELY 1028 00:42:28,000 --> 00:42:29,520 ENGAGED IN THE DEVELOPMENT IN 1029 00:42:29,520 --> 00:42:31,480 THE IMPROVEMENT OF TOOLBOX OVER 1030 00:42:31,480 --> 00:42:36,240 THE YEARS, ONCOLOGIC FOR EXAMPLE 1031 00:42:36,240 --> 00:42:38,080 WAS ORIGINALLY OPPT TOOL TAKEN 1032 00:42:38,080 --> 00:42:42,000 IN A FLUB OF YEARS AGO AND STAFF 1033 00:42:42,000 --> 00:42:52,480 PLAY A ROLE IN THE UPDATING 1034 00:42:54,680 --> 00:42:54,920 THAT. 1035 00:42:54,920 --> 00:42:57,480 OPPT HAS BECOME A LEADER IN THE 1036 00:42:57,480 --> 00:43:04,480 APPLICATION OF O.R. D TOOL 1037 00:43:04,480 --> 00:43:05,920 CALLED WEB-ICE. 1038 00:43:05,920 --> 00:43:08,240 ONE OF THE DIFFERENCES IS THE 1039 00:43:08,240 --> 00:43:16,080 PESTICIDE PROGRAM UNDER FIFRA 1040 00:43:16,080 --> 00:43:17,840 HAS SUBSTANTIAL CAPACITY, COMING 1041 00:43:17,840 --> 00:43:23,000 IN WITH EXTENSIVE DATABASES OF 1042 00:43:23,000 --> 00:43:23,840 TOXICITY INFORMATION, TENS OR 1043 00:43:23,840 --> 00:43:28,040 HUNDREDS OF MILLIONS OF ANIMAL 1044 00:43:28,040 --> 00:43:28,360 TESTING. 1045 00:43:28,360 --> 00:43:30,000 NO SUCH DATA EXISTS IN THE TOX 1046 00:43:30,000 --> 00:43:31,080 PROGRAM, THEY HAVE TO BE 1047 00:43:31,080 --> 00:43:37,960 CREATIVE HOW THEY USE AND 1048 00:43:37,960 --> 00:43:39,520 COLLECT INFORMATION. 1049 00:43:39,520 --> 00:43:40,880 INCREASING USING WEB-ICE TO 1050 00:43:40,880 --> 00:43:42,680 CORRELATE ACROSS SPECIES TO TAKE 1051 00:43:42,680 --> 00:43:44,760 THE LIMITED ECO-DATA THEY HAVE 1052 00:43:44,760 --> 00:43:47,840 AND EXPAND IT ACROSS THE FULL 1053 00:43:47,840 --> 00:43:49,600 ECOLOGICAL DATASET FOR DIFFERENT 1054 00:43:49,600 --> 00:43:50,240 SPECIES. 1055 00:43:50,240 --> 00:43:51,320 AND SEVERAL RISK EVALUATIONS 1056 00:43:51,320 --> 00:43:55,480 HAVE ACTUALLY ALREADY USED THE 1057 00:43:55,480 --> 00:43:56,880 WEB-ICE TOOL AND RISK 1058 00:43:56,880 --> 00:43:59,640 EVALUATIONS REVIEWED IN COMING 1059 00:43:59,640 --> 00:44:04,040 YEAR BY THE FACAs WILL EXPAND 1060 00:44:04,040 --> 00:44:05,880 THE USE OF THIS. 1061 00:44:05,880 --> 00:44:08,920 WITH THAT, I'LL STOP AND ASK IF 1062 00:44:08,920 --> 00:44:11,000 THERE ARE ANY QUESTIONS. 1063 00:44:11,000 --> 00:44:16,160 I THINK I GOT US BACK ON TIME. 1064 00:44:16,160 --> 00:44:16,400 [APPLAUSE] 1065 00:44:16,400 --> 00:44:22,200 1066 00:44:22,200 --> 00:44:22,600 1067 00:44:22,600 --> 00:44:23,800 >> ARE THERE ANY QUESTIONS IN 1068 00:44:23,800 --> 00:44:24,600 THE ROOM? 1069 00:44:24,600 --> 00:44:25,920 ANNA GOT US AHEAD OF SCHEDULE. 1070 00:44:25,920 --> 00:44:27,320 WE HAVE FIVE MINUTES. 1071 00:44:27,320 --> 00:44:29,480 SOME QUESTIONS HAVE COME IN 1072 00:44:29,480 --> 00:44:30,800 THROUGH THE ICCVAM QUESTIONS 1073 00:44:30,800 --> 00:44:31,880 E-MAIL ADDRESS FOR PREVIOUS 1074 00:44:31,880 --> 00:44:33,000 PRESENTERS SO WE CAN ADDRESS 1075 00:44:33,000 --> 00:44:34,200 THOSE BEFORE THE BREAK AS WELL 1076 00:44:34,200 --> 00:44:36,520 BUT FIRST ARE THERE ANY 1077 00:44:36,520 --> 00:44:39,080 QUESTIONS FOR ANNA? 1078 00:44:39,080 --> 00:44:44,600 1079 00:44:44,600 --> 00:44:45,480 VERY CLEAR, OKAY. 1080 00:44:45,480 --> 00:44:49,080 WE HAD A QUESTION COME IN ONLINE 1081 00:44:49,080 --> 00:44:50,480 FOR DR. GORDON, IF YOU WANT TO 1082 00:44:50,480 --> 00:44:51,480 COME BACK UP HERE. 1083 00:44:51,480 --> 00:44:54,120 DAVE, READ THE QUESTION PLEASE. 1084 00:44:54,120 --> 00:44:57,400 >> SURE. 1085 00:44:57,400 --> 00:45:00,920 FROM VICKIE FROM HSUS, CPSC 1086 00:45:00,920 --> 00:45:02,200 RECEIVED ANY SUBMISSIONS FROM 1087 00:45:02,200 --> 00:45:03,520 NAMs DEVELOPERS THROUGH THE 1088 00:45:03,520 --> 00:45:05,120 NEW PROCESS IN THE 2022 1089 00:45:05,120 --> 00:45:07,360 GUIDANCE, IF SO HOW LONG DO YOU 1090 00:45:07,360 --> 00:45:11,920 ANTICIPATE THE REVIEW PROCESS 1091 00:45:11,920 --> 00:45:12,160 TAKING? 1092 00:45:12,160 --> 00:45:13,800 >> WE HAVE ACCEPTED, GOTTEN A 1093 00:45:13,800 --> 00:45:16,240 COUPLE NOMINATIONS FOR METHODS 1094 00:45:16,240 --> 00:45:16,440 IN. 1095 00:45:16,440 --> 00:45:18,440 THOSE TOOK A LITTLE WHILE BUT 1096 00:45:18,440 --> 00:45:22,240 WE'RE MOSTLY WORKING ON THE WEB 1097 00:45:22,240 --> 00:45:24,000 PAGE TO UPDATE BEFORE WE STARTED 1098 00:45:24,000 --> 00:45:26,600 PUTTING MORE METHODS ON THE WEB 1099 00:45:26,600 --> 00:45:29,120 PAGE BECAUSE THE WAY IT WAS 1100 00:45:29,120 --> 00:45:31,080 BEFORE, IT WOULDN'T HAVE MADE 1101 00:45:31,080 --> 00:45:33,960 SENSE TO ADD INTO THE FORMAT WE 1102 00:45:33,960 --> 00:45:35,280 HAD BEFORE. 1103 00:45:35,280 --> 00:45:37,800 SO WE UPDATED, WE'VE UPDATED THE 1104 00:45:37,800 --> 00:45:40,440 WEBSITE, AND BOTH OF THOSE 1105 00:45:40,440 --> 00:45:41,840 METHODS, ONE IS ALREADY UP 1106 00:45:41,840 --> 00:45:45,680 THERE, THE OTHER WILL BE UP VERY 1107 00:45:45,680 --> 00:45:46,320 SOON. 1108 00:45:46,320 --> 00:45:47,960 IT'S IN CLEARANCE RIGHT NOW. 1109 00:45:47,960 --> 00:45:50,440 AND WILL BE IN FINAL CLEARANCE 1110 00:45:50,440 --> 00:45:52,600 NEXT WEEK. 1111 00:45:52,600 --> 00:45:54,360 IT WILL BE CLEARED WHEN WE CAN 1112 00:45:54,360 --> 00:45:56,440 PUT IT ON THE WEBSITE, A MATTER 1113 00:45:56,440 --> 00:45:59,680 OF DEALING WITH I.T. AND THEN 1114 00:45:59,680 --> 00:46:05,320 HOW EXACTLY WE'RE WE'RE GOING E 1115 00:46:05,320 --> 00:46:07,240 UPDATING AS WE MOVE FORWARD WILL 1116 00:46:07,240 --> 00:46:07,840 BE THE NEXT STEP. 1117 00:46:07,840 --> 00:46:09,240 >> OKAY, GREAT. 1118 00:46:09,240 --> 00:46:10,240 THANKS VERY MUCH, JOHN. 1119 00:46:10,240 --> 00:46:11,760 AND SO WE WILL TAKE A BREAK IN 1120 00:46:11,760 --> 00:46:13,760 JUST A MOMENT. 1121 00:46:13,760 --> 00:46:15,080 A REMINDER, TO THE FOLKS THAT 1122 00:46:15,080 --> 00:46:18,880 ARE VIEWING VIA THE WEBCAST 1123 00:46:18,880 --> 00:46:23,560 WHEN YOU GOT A REMINDER E-MAIL 1124 00:46:23,560 --> 00:46:25,960 ABOUT YOUR WEBCAST REGISTRATION 1125 00:46:25,960 --> 00:46:29,360 IT CAME FROM KATHERINE SPRINKLE 1126 00:46:29,360 --> 00:46:31,000 WITH THE THE E-MAIL ADDRESS IN 1127 00:46:31,000 --> 00:46:33,520 THE BODY OF THE E-MAIL, SO I'M 1128 00:46:33,520 --> 00:46:35,280 GOING TO PUT IT ON THE SLIDE AS 1129 00:46:35,280 --> 00:46:36,400 A PLACEHOLDER DURING THE BREAK, 1130 00:46:36,400 --> 00:46:38,200 SO YOU CAN SEE IT. 1131 00:46:38,200 --> 00:46:40,520 PROBABLY EASIEST TO JUST GO INTO 1132 00:46:40,520 --> 00:46:42,160 YOUR E-MAIL, SEARCH FOR 1133 00:46:42,160 --> 00:46:43,480 KATHERINE SPRINKLE OR PUBLIC 1134 00:46:43,480 --> 00:46:45,800 FORUM, WEBCAST AS KEY WORD AND 1135 00:46:45,800 --> 00:46:46,880 YOU'LL SEE THE CLICKABLE LINK 1136 00:46:46,880 --> 00:46:49,200 FOR THAT ARE ICCVAM QUESTIONS 1137 00:46:49,200 --> 00:46:50,520 E-MAIL ADDRESS, FEEL FREE TO 1138 00:46:50,520 --> 00:46:54,320 CONTINUE TO SEND QUESTIONS 1139 00:46:54,320 --> 00:46:55,760 DURING THE BREAK. 1140 00:46:55,760 --> 00:46:58,920 INDICATE WHICH SPEAKER AND WE 1141 00:46:58,920 --> 00:47:00,520 HAVE TIME BUILT INTO THE AGENDA 1142 00:47:00,520 --> 00:47:07,760 TO CEASE -- TO TAKE QUESTIONS. 1143 00:47:07,760 --> 00:47:16,280 WE'LL COME BACK AT 10:15. 1144 00:47:16,280 --> 00:47:19,320 >> WE'RE GOING TO RESUME THE 1145 00:47:19,320 --> 00:47:19,640 MEETING. 1146 00:47:19,640 --> 00:47:25,000 SO, FOLKS IN THE ROOM LOVE THAT 1147 00:47:25,000 --> 00:47:28,280 YOU'RE HAVING PRODUCTIVE 1148 00:47:28,280 --> 00:47:33,320 CONVERSATIONS BUT DON'T MAKE ME 1149 00:47:33,320 --> 00:47:35,320 START CALLING NAMES, ANNA. 1150 00:47:35,320 --> 00:47:37,600 [LAUGHTER] 1151 00:47:37,600 --> 00:47:40,200 OKAY. 1152 00:47:40,200 --> 00:47:42,160 SO WE DO HAVE ONE QUESTION THAT 1153 00:47:42,160 --> 00:47:51,840 CAME IN DURING THE BREAK FOR 1154 00:47:51,840 --> 00:47:52,480 ANNA. 1155 00:47:52,480 --> 00:47:52,680 DAVE? 1156 00:47:52,680 --> 00:47:54,760 OKAY. 1157 00:47:54,760 --> 00:47:55,480 1158 00:47:55,480 --> 00:48:01,840 >> THIS QUESTION IS FROM 1159 00:48:01,840 --> 00:48:02,080 MATTHEW. 1160 00:48:02,080 --> 00:48:08,240 IS THERE POSSIBILITY OF ADDING 1161 00:48:08,240 --> 00:48:14,360 NOEC POSITION TO ECOSAR TOOLS 1162 00:48:14,360 --> 00:48:15,200 CHRONIC ENDPOINT? 1163 00:48:15,200 --> 00:48:18,440 >> THANK YOU FOR THE QUESTION. 1164 00:48:18,440 --> 00:48:20,600 HOWEVER, IF IT'S POSSIBLE TO 1165 00:48:20,600 --> 00:48:22,040 RESPOND IN WRITING, AT A LATER 1166 00:48:22,040 --> 00:48:25,880 DATE, BECAUSE THAT'S REALLY A 1167 00:48:25,880 --> 00:48:27,840 QUESTION FOR OUR ORD COLLEAGUES 1168 00:48:27,840 --> 00:48:29,840 AT THE DULUTH LAB, MORE THAN IT 1169 00:48:29,840 --> 00:48:31,800 IS A PROGRAM OFFICE. 1170 00:48:31,800 --> 00:48:33,120 WE CAN HAPPILY GET BACK TO ON 1171 00:48:33,120 --> 00:48:34,960 YOU THE ANSWER TO THAT BUT I 1172 00:48:34,960 --> 00:48:36,840 DON'T THINK THERE'S ANYONE 1173 00:48:36,840 --> 00:48:38,800 ONLINE OR IN THE AUDIENCE TODAY 1174 00:48:38,800 --> 00:48:46,000 WHO KNOWS THE ANSWER TO THAT. 1175 00:48:46,000 --> 00:48:50,400 >> OKAY. 1176 00:48:50,400 --> 00:48:52,280 SO, KEEP THE QUESTIONS COMING. 1177 00:48:52,280 --> 00:48:53,160 WE'LL CONTINUE TO ADDRESS THEM 1178 00:48:53,160 --> 00:48:54,920 AS WE GET THEM. 1179 00:48:54,920 --> 00:49:02,320 SO OUR NEXT PRESENTER IS DR. 1180 00:49:02,320 --> 00:49:06,920 SUZIE FITZPATRICK, NEW 1181 00:49:06,920 --> 00:49:08,040 METHODOLOGIES IN FDA FOOD 1182 00:49:08,040 --> 00:49:08,360 SAFETY. 1183 00:49:08,360 --> 00:49:09,240 >> THANK YOU VERY MUCH FOR 1184 00:49:09,240 --> 00:49:11,520 ASKING ME TO TALK HERE TODAY. 1185 00:49:11,520 --> 00:49:13,320 I MADE A LITTLE BIT OF A MISTAKE 1186 00:49:13,320 --> 00:49:14,840 ON THE DATE. 1187 00:49:14,840 --> 00:49:16,800 I HOPE WE'RE STILL NOT TALKING 1188 00:49:16,800 --> 00:49:20,320 ABOUT THIS 300 YEARS FROM NOW, 1189 00:49:20,320 --> 00:49:21,800 SOMETIMES IT SEEMS LIKE WE MIGHT 1190 00:49:21,800 --> 00:49:22,040 BE. 1191 00:49:22,040 --> 00:49:23,920 I'M GOING TO PRESENT NEW 1192 00:49:23,920 --> 00:49:26,720 APPROACH METHODS FOR USE IN FDA 1193 00:49:26,720 --> 00:49:27,400 FOODS PROGRAM. 1194 00:49:27,400 --> 00:49:28,840 TOMORROW YOU'LL SEE WHAT WE'RE 1195 00:49:28,840 --> 00:49:29,760 DOING IN TOBACCO. 1196 00:49:29,760 --> 00:49:33,880 FAULD, IF YOU D. -- FDA HAS SIX 1197 00:49:33,880 --> 00:49:38,480 MEDICAL PERHAPS, THREE MEDICAL 1198 00:49:38,480 --> 00:49:40,640 CENTERS, DEVICE, BIOLOGICS, 1199 00:49:40,640 --> 00:49:42,280 DRUGS, TOBACCO AND FOOD. 1200 00:49:42,280 --> 00:49:44,280 AND WE ALL RECOGNIZE AND HAVE 1201 00:49:44,280 --> 00:49:46,000 BEEN TOLD BY THE OFFICE OF CHIEF 1202 00:49:46,000 --> 00:49:47,520 SCIENTIST THAT WE NEED TO BRING 1203 00:49:47,520 --> 00:49:50,600 PRODUCTS TO THE MARKET FASTER, 1204 00:49:50,600 --> 00:49:53,920 WE NEED TO INCORPORATE NEW TOOS 1205 00:49:53,920 --> 00:49:57,560 FOR OUR METHODS 1206 00:49:57,560 --> 00:49:59,560 EACH OF OUR SIX PRODUCT CENTERS 1207 00:49:59,560 --> 00:50:05,560 ARE UNIQUE AND WE'VE BEEN ASKED 1208 00:50:05,560 --> 00:50:07,680 TO CONCENTRATE ON DEVELOPING, IF 1209 00:50:07,680 --> 00:50:08,400 WE HAVEN'T ALREADY, 1210 00:50:08,400 --> 00:50:09,520 QUALIFICATION PROGRAMS. 1211 00:50:09,520 --> 00:50:12,240 YOU HEARD ABOUT THE MEDICAL 1212 00:50:12,240 --> 00:50:16,080 DEVICE PROGRAM FROM DR. GORDON. 1213 00:50:16,080 --> 00:50:20,800 WE ALSO HAVE I-STAND AND DDD 1214 00:50:20,800 --> 00:50:22,800 BIOMARKER PROGRAM AT CDER. 1215 00:50:22,800 --> 00:50:24,920 THIS IS A REPORT DONNA AND I PUT 1216 00:50:24,920 --> 00:50:26,120 TOGETHER, CHAIR THE ALTERNATIVE 1217 00:50:26,120 --> 00:50:30,480 METHODS WORK GROUP, A 1218 00:50:30,480 --> 00:50:32,840 CROSS-AGENCY WORK GROUP OF 1219 00:50:32,840 --> 00:50:34,200 SENIOR SCIENTISTS, WORKING 1220 00:50:34,200 --> 00:50:35,480 ACROSS THE AGENCY ON THINGS 1221 00:50:35,480 --> 00:50:36,720 WE'RE DOING UNIQUELY IN OUR 1222 00:50:36,720 --> 00:50:41,320 AGENCY AND SHARE WITH OTHERS. 1223 00:50:41,320 --> 00:50:42,520 THIS IS ON OUR WEBSITE. 1224 00:50:42,520 --> 00:50:51,160 IF YOU TYPE IN ALTERNATIVES AT 1225 00:50:51,160 --> 00:50:52,480 FDA.GOV, IT'S BEING UPDATED BUT 1226 00:50:52,480 --> 00:50:54,200 I THINK YOU CAN GET ONTO IT. 1227 00:50:54,200 --> 00:50:59,680 IF I HAD TO WRITE ANOTHER ONE OF 1228 00:50:59,680 --> 00:51:01,560 THESE, I WOULD ADD THE CONTEXT 1229 00:51:01,560 --> 00:51:02,760 OF USE. 1230 00:51:02,760 --> 00:51:04,840 WE GAVE IT A SNAPSHOT OF WE 1231 00:51:04,840 --> 00:51:06,040 SEARCH BUT WE DIDN'T SAY WHY WE 1232 00:51:06,040 --> 00:51:07,680 WERE DOING IT. 1233 00:51:07,680 --> 00:51:09,320 THAT'S REALLY IMPORTANT I THINK, 1234 00:51:09,320 --> 00:51:10,840 FOR FDA. 1235 00:51:10,840 --> 00:51:11,920 START WITH REGULATORY QUESTION, 1236 00:51:11,920 --> 00:51:14,360 AND DO THE RESEARCH TO ANSWER IT 1237 00:51:14,360 --> 00:51:16,760 AND FILL THE GAPS WE NEED TO 1238 00:51:16,760 --> 00:51:17,960 REGULATE OUR PRODUCTS. 1239 00:51:17,960 --> 00:51:21,360 I WENT THE WRONG WAY. 1240 00:51:21,360 --> 00:51:23,640 I WORK AT CFSAN. 1241 00:51:23,640 --> 00:51:25,280 OUR PRODUCTS LACK PRE-APPROVAL 1242 00:51:25,280 --> 00:51:26,160 AUTHORITY THAT. 1243 00:51:26,160 --> 00:51:29,800 MEANS WE HAVE TO SHOW -- SO FOR 1244 00:51:29,800 --> 00:51:33,600 EXCEPT FOR FOOD OF DIRECT FOOD 1245 00:51:33,600 --> 00:51:36,240 ADDITIVE AND PACKAGES, WE HAVE 1246 00:51:36,240 --> 00:51:37,760 TO DEMONSTRATE HARM ACCORDING TO 1247 00:51:37,760 --> 00:51:38,880 LABEL USE BEFORE WE CAN DO 1248 00:51:38,880 --> 00:51:40,720 ANYTHING ABOUT IT. 1249 00:51:40,720 --> 00:51:43,480 IT'S VERY IMPORTANT FOR US TO 1250 00:51:43,480 --> 00:51:45,440 DEVELOP THESE NEW METHODS TO 1251 00:51:45,440 --> 00:51:46,800 HELP US IDENTIFY TOXICITY IN 1252 00:51:46,800 --> 00:51:48,040 THESE DIFFERENT PRODUCTS IN THE 1253 00:51:48,040 --> 00:51:49,840 MARKET, AND ARE BEING USED BY 1254 00:51:49,840 --> 00:51:56,800 YOUR FAMILY. 1255 00:51:56,800 --> 00:51:58,360 INCLUDING DIETARY SUPPLEMENT, 1256 00:51:58,360 --> 00:52:00,840 COSMETICS, GRAS, METALS IN BABY 1257 00:52:00,840 --> 00:52:02,480 FOOD, CONSTITUENTS DEVELOPED 1258 00:52:02,480 --> 00:52:05,560 WHEN YOU HEAT FOOD, THERE'S A 1259 00:52:05,560 --> 00:52:07,200 PROCESS THAT OF THAT ENDS UP IN 1260 00:52:07,200 --> 00:52:09,760 FOOD, ABOUT A THOUSAND OF THEM. 1261 00:52:09,760 --> 00:52:12,520 IT'S NOT ACCEPTABLE TO OUR 1262 00:52:12,520 --> 00:52:13,880 CONSUMERS AND STAKEHOLDERS TO 1263 00:52:13,880 --> 00:52:15,200 SAY LET ME DO AN ANIMAL STUDY 1264 00:52:15,200 --> 00:52:17,080 AND I'LL BE BACK IN TWO YEARS TO 1265 00:52:17,080 --> 00:52:18,920 TELL YOU IF THAT'S A PROBLEM OR 1266 00:52:18,920 --> 00:52:19,280 NOT. 1267 00:52:19,280 --> 00:52:20,720 IT'S ESSENTIAL FOR US TO DEVELOP 1268 00:52:20,720 --> 00:52:25,640 NEW APPROACH METHODS. 1269 00:52:25,640 --> 00:52:28,160 WE HAVE A PROGRAM TO MOVE AWAY 1270 00:52:28,160 --> 00:52:28,840 FROM ANIMAL STUDIES. 1271 00:52:28,840 --> 00:52:31,320 WE'VE GOTTEN RID OF ALL THE 1272 00:52:31,320 --> 00:52:35,040 ANIMALS IN OUR LAB, IF WE DO 1273 00:52:35,040 --> 00:52:38,520 ANIMAL STUDIES WE MIGHT LEAN ON 1274 00:52:38,520 --> 00:52:41,640 NCTR, BUT ALSO HAVING LESS RELY 1275 00:52:41,640 --> 00:52:43,920 ANSWER ON ANIMAL STUDIES, TRYING 1276 00:52:43,920 --> 00:52:45,080 DO TAILORED DATA STUDIES BASED 1277 00:52:45,080 --> 00:52:46,640 ON GENERATION, I'LL TALK ABOUT 1278 00:52:46,640 --> 00:52:47,520 WHAT WE'RE DOING. 1279 00:52:47,520 --> 00:52:50,160 SO LET'S SEE IF I CAN GET THIS 1280 00:52:50,160 --> 00:52:55,840 TO THE NEXT ONE. 1281 00:52:55,840 --> 00:52:56,080 OKAY. 1282 00:52:56,080 --> 00:52:58,440 SO, IN 2017, REALLY IN ANSWER TO 1283 00:52:58,440 --> 00:53:00,760 THE FACT THAT EPA WAS PUTTING 1284 00:53:00,760 --> 00:53:05,000 OUT THESE GUIDANCES, AND WE HAVE 1285 00:53:05,000 --> 00:53:05,960 INTERAGENCY COMPETITION. 1286 00:53:05,960 --> 00:53:09,400 WE DECIDED WE WOULD PUT TOGETHER 1287 00:53:09,400 --> 00:53:10,920 OUR FDA PREDICTIVE TOXICOLOGY 1288 00:53:10,920 --> 00:53:11,600 ROADMAP. 1289 00:53:11,600 --> 00:53:13,560 I CHAIRED THIS COMMITTEE. 1290 00:53:13,560 --> 00:53:14,840 THIS GAVE A STRATEGY, IF YOU GO 1291 00:53:14,840 --> 00:53:17,640 TO THE NEXT ONE, GAVE US A 1292 00:53:17,640 --> 00:53:19,880 SIX-PART FRAMEWORK FOR HOW WE'RE 1293 00:53:19,880 --> 00:53:21,680 GOING TO ENHANCE FDA ENGAGEMENT 1294 00:53:21,680 --> 00:53:23,480 IN THE SCIENCE OF TOXICOLOGY. 1295 00:53:23,480 --> 00:53:26,040 WE WANTED TO DEMONSTRATE TO OUR 1296 00:53:26,040 --> 00:53:27,200 STAKEHOLDERS WE WERE INTERESTED 1297 00:53:27,200 --> 00:53:29,000 AND COMMITTED TO THE DEVELOPMENT 1298 00:53:29,000 --> 00:53:31,520 OF NEW TECHNOLOGIES, AND WE HAD 1299 00:53:31,520 --> 00:53:33,360 SIX PRINCIPLES TO WORK ON. 1300 00:53:33,360 --> 00:53:36,120 AND WE ARE ASKED BY CONGRESS, 1301 00:53:36,120 --> 00:53:37,840 I'M SURPRISED I'M STILL ASKED 1302 00:53:37,840 --> 00:53:43,400 ABOUT THIS AFTER WORKING ON A 1303 00:53:43,400 --> 00:53:45,160 DOCUMENT FIVE YEARS, WHAT ARE WE 1304 00:53:45,160 --> 00:53:47,040 DOING TO FOLLOW THESE SIX 1305 00:53:47,040 --> 00:53:47,320 PRINCIPLES. 1306 00:53:47,320 --> 00:53:48,680 FOR THE FOODS PROGRAM I'LL SHOW 1307 00:53:48,680 --> 00:53:54,280 YOU HOW WE'RE INCORPORATING THIS 1308 00:53:54,280 --> 00:53:55,280 INTO OUR WORK. 1309 00:53:55,280 --> 00:53:57,120 AM I GOING THE RIGHT DIRECTION? 1310 00:53:57,120 --> 00:53:58,720 THESE ARE THE PRINCIPLES. 1311 00:53:58,720 --> 00:54:01,720 I'LL GO THROUGH EACH SEPARATELY, 1312 00:54:01,720 --> 00:54:03,720 SIX PRINCIPLES THAT ALL OF THE 1313 00:54:03,720 --> 00:54:05,960 CENTERS ARE DOING, A LOT HAVE 1314 00:54:05,960 --> 00:54:06,480 DIFFERENT QUALIFICATION 1315 00:54:06,480 --> 00:54:07,720 PROGRAMS, LIKE I SAID WE HAVE 1316 00:54:07,720 --> 00:54:09,040 DIFFERENT PRODUCTS. 1317 00:54:09,040 --> 00:54:11,440 YOU'LL SEE WHAT WE'RE DOING IN 1318 00:54:11,440 --> 00:54:12,200 TOBACCO. 1319 00:54:12,200 --> 00:54:14,080 SO THE FIRST THING IS IT WAS TO 1320 00:54:14,080 --> 00:54:15,600 PUT TOGETHER A SENIOR LEVEL 1321 00:54:15,600 --> 00:54:16,480 TOXICOLOGY WORKING GROUP. 1322 00:54:16,480 --> 00:54:17,640 THAT'S WHAT WE'VE DONE HERE 1323 00:54:17,640 --> 00:54:20,840 UNDER THE OFFICE OF THE CENTER 1324 00:54:20,840 --> 00:54:22,720 DIRECTOR, WE PUT TOGETHER A 1325 00:54:22,720 --> 00:54:25,160 GROUP THAT CONTAINS NOT ONLY 1326 00:54:25,160 --> 00:54:26,280 SENIOR PEOPLE, NOT ONLY PEOPLE 1327 00:54:26,280 --> 00:54:29,440 IN THE REGULATORY PART OF FDA 1328 00:54:29,440 --> 00:54:32,400 BUT IN RESEARCH LABS AND JUNIOR 1329 00:54:32,400 --> 00:54:34,240 SCIENTISTS TOO, SO WE CAN MAKE 1330 00:54:34,240 --> 00:54:38,520 SURE WE HAVE -- HE SAID DON'T BE 1331 00:54:38,520 --> 00:54:40,680 OFFENDED THAT WE NEED SUCCESSION 1332 00:54:40,680 --> 00:54:42,000 SO WHEN WE'RE GONE PEOPLE ARE 1333 00:54:42,000 --> 00:54:42,760 WORKING ON THIS. 1334 00:54:42,760 --> 00:54:44,840 WE'VE DONE A LOT OF THAT. 1335 00:54:44,840 --> 00:54:48,360 ONE OF THE THINGS THAT I DO IS 1336 00:54:48,360 --> 00:54:50,840 MAKE SURE, I'LL TALK ABOUT IT 1337 00:54:50,840 --> 00:54:52,640 LATER, IF I CAN GIVE A TALK AND 1338 00:54:52,640 --> 00:54:54,400 HAVE JUNIOR PERSON DO IT FOR ME 1339 00:54:54,400 --> 00:54:55,440 INSTEAD, NOT THAT I'M TRYING TO 1340 00:54:55,440 --> 00:54:57,520 GET OUT OF WORK BUT I WANT TO 1341 00:54:57,520 --> 00:55:01,120 GIVE THEM THE EXPERIENCE, THE 1342 00:55:01,120 --> 00:55:02,240 NETWORKING, SO THEY CAN CONTINUE 1343 00:55:02,240 --> 00:55:03,000 ANYTHING WE DO. 1344 00:55:03,000 --> 00:55:05,120 YOU'LL SEE THEM AS WE WORK ON 1345 00:55:05,120 --> 00:55:06,120 OUR PROJECTS. 1346 00:55:06,120 --> 00:55:08,280 WE ARE ACTUALLY PART OF WHAT'S 1347 00:55:08,280 --> 00:55:12,640 CALLED THIS KICK PROGRAM FOR 1348 00:55:12,640 --> 00:55:13,880 CHEMICALS, DEADLINES TO MEET TO 1349 00:55:13,880 --> 00:55:15,560 ACCOMPLISH ALL THESE GOALS. 1350 00:55:15,560 --> 00:55:19,000 DEADLINES TO THE OFFICE OF 1351 00:55:19,000 --> 00:55:20,200 CENTER DIRECTOR AND 1352 00:55:20,200 --> 00:55:20,840 COMMISSIONER. 1353 00:55:20,840 --> 00:55:21,960 WE'VE DEVELOPED A CHARTER FOR 1354 00:55:21,960 --> 00:55:23,400 NAMs WORKING GROUP, TO 1355 00:55:23,400 --> 00:55:24,680 IDENTIFY WHAT'S BEING CURRENTLY 1356 00:55:24,680 --> 00:55:27,240 USED IN THE FOOD INDUSTRY, 1357 00:55:27,240 --> 00:55:29,960 ACADEMIC AND OTHER GOVERNMENT 1358 00:55:29,960 --> 00:55:31,160 AGENCIES, NATIONALLY AND 1359 00:55:31,160 --> 00:55:33,800 INTERNATIONALLY, DEVELOP A PLAN 1360 00:55:33,800 --> 00:55:44,320 TO EVALUATE THE APPLICABILITY. 1361 00:55:45,960 --> 00:55:47,000 WE'RE WORKING ON POSSIBLE 1362 00:55:47,000 --> 00:55:49,840 QUESTIONS THAT WE WOULD ASK ANY 1363 00:55:49,840 --> 00:55:51,600 COMPOUND IN VALIDATION, MIGHT 1364 00:55:51,600 --> 00:55:57,400 NEED DIFFERENT TYPE OF GUIDANCE 1365 00:55:57,400 --> 00:55:58,720 FOR MICROPHYSIOLOGICAL SYSTEMS 1366 00:55:58,720 --> 00:56:03,240 VERSUS IN SILICO VERSUS BIOLOGIC 1367 00:56:03,240 --> 00:56:04,560 OR BIOMARKERS, STAKEHOLDER 1368 00:56:04,560 --> 00:56:06,320 WORKSHOPS ON CRITERIA, NAMs, 1369 00:56:06,320 --> 00:56:07,200 STATUS, GAPS, IT'S VERY 1370 00:56:07,200 --> 00:56:09,360 IMPORTANT TO WORK WITH ALL OF 1371 00:56:09,360 --> 00:56:11,560 OUR STAKEHOLDERS ACROSS THE 1372 00:56:11,560 --> 00:56:14,520 FEDERAL AGENCY, FEDERAL FAMILY, 1373 00:56:14,520 --> 00:56:16,160 AND ALL OF YOU HERE TO PUT THESE 1374 00:56:16,160 --> 00:56:19,960 IN PLACE BECAUSE WE ALL WANT A 1375 00:56:19,960 --> 00:56:20,880 SAFE FOOD SUPPLY. 1376 00:56:20,880 --> 00:56:24,800 AS I TALKED WITH TRAINING OF OUR 1377 00:56:24,800 --> 00:56:27,440 CFSAN REGULATORS AND RESEARCHES, 1378 00:56:27,440 --> 00:56:28,560 MAKING SURE THERE'S EDUCATION. 1379 00:56:28,560 --> 00:56:32,360 WE'RE PUTTING UP A WEBSITE SO 1380 00:56:32,360 --> 00:56:34,560 THEY CAN SEE WHERE ANY PAPERS 1381 00:56:34,560 --> 00:56:37,280 THAT ARE ESSENTIAL TO THEM, ANY 1382 00:56:37,280 --> 00:56:38,840 WORKSHOPS, ANYTHING THAT'S 1383 00:56:38,840 --> 00:56:40,800 AVAILABLE TO THEM. 1384 00:56:40,800 --> 00:56:42,560 WE ARE DOING TRAINING BY DOING, 1385 00:56:42,560 --> 00:56:44,640 AS I CALL IT. 1386 00:56:44,640 --> 00:56:46,800 WE HAVE, FOR EXAMPLE, TALKING TO 1387 00:56:46,800 --> 00:56:52,160 THE U.K. ABOUT THEIR ROADMAP FOR 1388 00:56:52,160 --> 00:56:53,800 FOOD SAFETY, AND INSTEAD OF ME 1389 00:56:53,800 --> 00:56:57,520 LEADING THAT WE HAVE TWO OF OUR 1390 00:56:57,520 --> 00:57:01,200 PROMISENING I HATE TO SAY JUNIOR 1391 00:57:01,200 --> 00:57:02,160 SCIENTISTS BUT YOUNGER THAN ME 1392 00:57:02,160 --> 00:57:03,680 THAT WILL TAKE THE LEAN ON SOME 1393 00:57:03,680 --> 00:57:07,480 OF THESE THINGS AS WELL AS GO 1394 00:57:07,480 --> 00:57:08,240 SOME INTERNATIONAL ACTIVITIES. 1395 00:57:08,240 --> 00:57:09,680 SO THAT WE MAKE SURE THAT IT'S 1396 00:57:09,680 --> 00:57:11,560 NOT JUST A COUPLE PEOPLE WHEN WE 1397 00:57:11,560 --> 00:57:14,640 LEAVE, IF WE CAN LEAVE, THEY 1398 00:57:14,640 --> 00:57:16,120 CAN -- IT STILL CONTINUES. 1399 00:57:16,120 --> 00:57:19,320 THAT'S WHAT WE CALL CONTINUE BY 1400 00:57:19,320 --> 00:57:19,520 DOING. 1401 00:57:19,520 --> 00:57:22,560 THIS LOOKS LIKE IT'S GOING ON 1402 00:57:22,560 --> 00:57:23,480 ITS OWN. 1403 00:57:23,480 --> 00:57:23,840 TRAINING, OKAY. 1404 00:57:23,840 --> 00:57:25,680 I DON'T KNOW WHAT I PUSHED. 1405 00:57:25,680 --> 00:57:28,600 I PUSHED IT. 1406 00:57:28,600 --> 00:57:29,160 OKAY. 1407 00:57:29,160 --> 00:57:30,240 COLLABORATION WITH STAKEHOLDERS, 1408 00:57:30,240 --> 00:57:31,360 IT'S VERY IMPORTANT AND I THINK 1409 00:57:31,360 --> 00:57:35,400 ALL OF FDA FEELS THAT WAY TO 1410 00:57:35,400 --> 00:57:36,720 COLLABORATE ACROSS SECTORS, 1411 00:57:36,720 --> 00:57:37,920 DISCIPLINES, NATIONALLY AND 1412 00:57:37,920 --> 00:57:38,440 INTERNATIONALLY. 1413 00:57:38,440 --> 00:57:40,520 WE SUPPORT THE IMPORTANCE THESE 1414 00:57:40,520 --> 00:57:41,440 COLLABORATIONS, I'LL TELL YOU 1415 00:57:41,440 --> 00:57:44,040 HOW CAN YOU COLLABORATE WITH THE 1416 00:57:44,040 --> 00:57:47,200 FDA IN A MINUTE, AND HERE ARE 1417 00:57:47,200 --> 00:57:48,080 POTENTIAL PARTNERSHIPS TO WORK 1418 00:57:48,080 --> 00:57:52,040 WITH CFSAN. 1419 00:57:52,040 --> 00:57:54,120 IT'S NOT ON THIS SLIDE BUT I 1420 00:57:54,120 --> 00:57:57,960 WORK ON A WHITE HOUSE INITIATIVE 1421 00:57:57,960 --> 00:58:00,120 ON CONTAMINANTS OF EMERGING 1422 00:58:00,120 --> 00:58:00,760 CONCERN UNDER OSTP. 1423 00:58:00,760 --> 00:58:02,640 COMING OUT OF THE WHITE HOUSE IS 1424 00:58:02,640 --> 00:58:04,720 AN INITIATIVE WE WORK ACROSS 1425 00:58:04,720 --> 00:58:07,360 FEDERAL AGENCIES ON ALL THESE 1426 00:58:07,360 --> 00:58:09,400 PROBLEMS THAT WE HAVE, IT'S NO 1427 00:58:09,400 --> 00:58:11,160 LONGER ONE AGENCY OR EVEN ONE 1428 00:58:11,160 --> 00:58:13,240 PART OF AN AGENCY, WE'RE ACROSS 1429 00:58:13,240 --> 00:58:16,520 AGENCIES, AND WHEN WE HAVE THESE 1430 00:58:16,520 --> 00:58:18,400 CROSS--AGENCY TALKS OUT POINT 1431 00:58:18,400 --> 00:58:21,280 OUT ICCVAM IS A VERY GOOD 1432 00:58:21,280 --> 00:58:22,560 EXAMPLE OF A CROSS-AGENCY, 17 1433 00:58:22,560 --> 00:58:23,320 AGENCIES WORKING TOGETHER. 1434 00:58:23,320 --> 00:58:25,320 YOU HAVE TO BE IN THE FEDERAL 1435 00:58:25,320 --> 00:58:26,320 GOVERNMENT TO UNDERSTAND HOW 1436 00:58:26,320 --> 00:58:27,480 UNIQUE AND IMPORTANT THAT IS. 1437 00:58:27,480 --> 00:58:29,560 SOMETIMES IT'S HARD TO JUST WORK 1438 00:58:29,560 --> 00:58:31,320 ACROSS YOUR OWN AGENCY. 1439 00:58:31,320 --> 00:58:32,960 I THINK KUDOS TO NICOLE AND DAVE 1440 00:58:32,960 --> 00:58:35,120 AND ALL THOSE THAT KEEP THAT 1441 00:58:35,120 --> 00:58:38,320 GOING, IT'S A GOOD EXAMPLE AS WE 1442 00:58:38,320 --> 00:58:41,040 WORK WITH NIEHS THROUGH THIS 1443 00:58:41,040 --> 00:58:42,680 CROSS-AGENCY LOOKING AT 1444 00:58:42,680 --> 00:58:43,360 CONTAMINANTS OF EMERGING 1445 00:58:43,360 --> 00:58:43,600 CONCERN. 1446 00:58:43,600 --> 00:58:44,960 THERE'S OTHERS WAYS. 1447 00:58:44,960 --> 00:58:45,840 WE HAVE PUBLIC/PRIVATE 1448 00:58:45,840 --> 00:58:46,960 PARTNERSHIP PARTNERSHIPS WHERE 1449 00:58:46,960 --> 00:58:51,680 WE'RE INVITED TO PARTICIPATE. 1450 00:58:51,680 --> 00:58:53,600 WE ALSO HAVE CDRH DEVELOPED 1451 00:58:53,600 --> 00:58:55,160 COLLECTIVE COMMUNITY WHERE 20 OR 1452 00:58:55,160 --> 00:58:57,800 SO PEOPLE INCLUDING FDA AND 1453 00:58:57,800 --> 00:58:59,760 OUTSIDE FDA TALK ABOUT SCIENCE 1454 00:58:59,760 --> 00:59:00,880 PROBLEMS TOGETHER. 1455 00:59:00,880 --> 00:59:02,720 WE COULD DO A MEMORANDUM OF 1456 00:59:02,720 --> 00:59:04,520 UNDERSTANDING ALTHOUGH THIS IS 1457 00:59:04,520 --> 00:59:05,000 USUALLY BETWEEN FEDERAL 1458 00:59:05,000 --> 00:59:07,000 AGENCIES, AND WE HAVE A 1459 00:59:07,000 --> 00:59:10,960 MEMORANDUM OF UNDERSTANDING WITH 1460 00:59:10,960 --> 00:59:15,000 TOX21 TO WORK BETWEEN US AND 1461 00:59:15,000 --> 00:59:19,280 EPA, NCATS, NIEHS, TO WORK ON 1462 00:59:19,280 --> 00:59:19,640 ALTERNATIVES. 1463 00:59:19,640 --> 00:59:23,120 WE JUST COMPLETED WHAT WAS A 1464 00:59:23,120 --> 00:59:25,080 MEMORANDUM OF UNDERSTANDING OR 1465 00:59:25,080 --> 00:59:26,600 AGREEMENT WITH NCATS TO DEVELOP 1466 00:59:26,600 --> 00:59:28,680 BETWEEN THE OF TWO US A 1467 00:59:28,680 --> 00:59:32,520 NEUROMUSCULAR JUNCTION ON A CHIP 1468 00:59:32,520 --> 00:59:34,800 FOR BOD TOX TESTING, PUTTING OUT 1469 00:59:34,800 --> 00:59:35,800 SOLICITATIONS, ALREADY OUT THERE 1470 00:59:35,800 --> 00:59:37,880 FOR ONE ACADEMIC LAB AND ONE 1471 00:59:37,880 --> 00:59:39,880 COMMERCIAL LAB TO DEVELOP A 1472 00:59:39,880 --> 00:59:43,360 NEUROMUSCULAR JUNCTION ON A CHIP 1473 00:59:43,360 --> 00:59:46,400 AND FDA WILL QUALIFY IT BASED ON 1474 00:59:46,400 --> 00:59:51,680 GOOD OR BETTER CRITERIA AGAINST 1475 00:59:51,680 --> 00:59:53,080 THE MOUSE LETHALITY TEST. 1476 00:59:53,080 --> 00:59:55,720 WE SEE THIS JUNCTION ON A CHIP 1477 00:59:55,720 --> 00:59:59,320 AS FOR A BIGGER SCOPE THAN JUST 1478 00:59:59,320 --> 01:00:01,080 BOT TOX TESTING FOR TOXIN 1479 01:00:01,080 --> 01:00:01,720 TESTING. 1480 01:00:01,720 --> 01:00:04,240 BECAUSE OF THAT AS WE WORK 1481 01:00:04,240 --> 01:00:09,880 MONTHLY WITH THE PEOPLE THAT GET 1482 01:00:09,880 --> 01:00:11,040 THE SOLICITATIONS TO MAKE SURE 1483 01:00:11,040 --> 01:00:14,120 THEY MEET FDA GOAL, SAME WITH 1484 01:00:14,120 --> 01:00:15,640 DARPA, INCLUDING OTHER FEDERAL 1485 01:00:15,640 --> 01:00:17,160 PARTNERS, DoD, OTHER CENTERS 1486 01:00:17,160 --> 01:00:19,240 TO MAKE SURE THAT WE'RE 1487 01:00:19,240 --> 01:00:20,680 DEVELOPING A TOOL THAT CAN MEET 1488 01:00:20,680 --> 01:00:23,960 A LOT OF PEOPLE'S NEEDS AND THEY 1489 01:00:23,960 --> 01:00:25,840 FEEL CONFIDENT IN THE DATA. 1490 01:00:25,840 --> 01:00:28,120 WE HAVE RESEARCH COLLABORATION 1491 01:00:28,120 --> 01:00:29,440 AGREEMENTS, JOINT RESEARCH 1492 01:00:29,440 --> 01:00:32,480 TOGETHER, WITH OUR PARTNERS, WE 1493 01:00:32,480 --> 01:00:37,440 HAVE SOME WITH ACADEMICS, SOME 1494 01:00:37,440 --> 01:00:41,280 WITH INDUSTRY, AND SO THEY ARE 1495 01:00:41,280 --> 01:00:43,440 NOT LIKE KIND OF SEGREGATED TO 1496 01:00:43,440 --> 01:00:44,200 JUST INDUSTRY. 1497 01:00:44,200 --> 01:00:47,760 IF SOMEONE HAD AN IDEA AND CAME 1498 01:00:47,760 --> 01:00:49,800 TO US, THIS IS ON SCIENCE ISSUES 1499 01:00:49,800 --> 01:00:53,720 THAT MIGHT LEAD TO REGULATORY 1500 01:00:53,720 --> 01:01:01,200 DECISIONS, AND THEN WE ALSO HAVE 1501 01:01:01,200 --> 01:01:04,640 CRADAs, TECHNOLOGIES ARE MOVED 1502 01:01:04,640 --> 01:01:06,440 INTO THE LABORATORY LIKE WE DID 1503 01:01:06,440 --> 01:01:09,600 WITH ORGANS ON THE CHIP, EMULATE 1504 01:01:09,600 --> 01:01:12,040 THE FOODS LAB, IN SEVERAL OF OUR 1505 01:01:12,040 --> 01:01:12,240 LABS. 1506 01:01:12,240 --> 01:01:16,080 WE ALSO HAVE -- WE ALSO HAVE A 1507 01:01:16,080 --> 01:01:20,120 CRADA WE'RE DEVELOPING WITH 1508 01:01:20,120 --> 01:01:27,680 CANADA TO MOVE THEIR 1509 01:01:27,680 --> 01:01:28,600 NEUROMUSCULAR CHIP. 1510 01:01:28,600 --> 01:01:29,560 WE TALK ABOUT CRITERIA TO ACCEPT 1511 01:01:29,560 --> 01:01:30,560 THE DATA. 1512 01:01:30,560 --> 01:01:33,160 IT'S A VERY GOOD WAY TO GET 1513 01:01:33,160 --> 01:01:36,800 SOMETHING, EVERYONE TO GET 1514 01:01:36,800 --> 01:01:37,960 SOMETHING OUT OF THESE 1515 01:01:37,960 --> 01:01:38,520 PARTNERSHIPS. 1516 01:01:38,520 --> 01:01:41,280 I MIGHT SAY THAT ANOTHER ONE WE 1517 01:01:41,280 --> 01:01:42,320 CREATED IS INTERNATIONAL LIAISON 1518 01:01:42,320 --> 01:01:44,440 GROUP ON METHODS FOR RISK 1519 01:01:44,440 --> 01:01:46,160 ASSESSMENT OF CHEMICALS AND 1520 01:01:46,160 --> 01:01:52,200 FOOD, A PARTNERSHIP WITH CFSAN, 1521 01:01:52,200 --> 01:02:02,600 FSA, AND CHINA, KOREA, JAPAN, 1522 01:02:02,600 --> 01:02:03,800 SINGAPORE AND CANADA, WE'VE 1523 01:02:03,800 --> 01:02:05,840 ALREADY HAVE A LIST OF PRIORITY 1524 01:02:05,840 --> 01:02:06,200 ITEMS. 1525 01:02:06,200 --> 01:02:16,040 THIS IS JUST THE PEOPLE THAT ARE 1526 01:02:16,040 --> 01:02:17,160 INVOLVED IN IT. 1527 01:02:17,160 --> 01:02:21,320 WE'RE DOING IT FOR THE FOOD 1528 01:02:21,320 --> 01:02:22,920 INDUSTRY, ACROSS THE GLOBAL, 1529 01:02:22,920 --> 01:02:28,560 NON-GUIDELINE STUDIES TO LOOK AT 1530 01:02:28,560 --> 01:02:29,520 MIXTURES, DEVELOPMENTAL NEURO, 1531 01:02:29,520 --> 01:02:31,160 RECENTLY LOOKED AT BUILDING 1532 01:02:31,160 --> 01:02:32,360 CONFIDENCE IN THESE METHODS, 1533 01:02:32,360 --> 01:02:34,240 WORKING TOGETHER. 1534 01:02:34,240 --> 01:02:36,200 SO IT INCREASES FDA'S ABILITY TO 1535 01:02:36,200 --> 01:02:41,680 ADOPT THESE WHEN WE GET GLOBAL 1536 01:02:41,680 --> 01:02:42,880 HARMONIZATION AND WE'RE WORKING 1537 01:02:42,880 --> 01:02:48,880 WITH THE U.K. TO LOOK AT IN 1538 01:02:48,880 --> 01:02:49,520 SILICO MODELS, PACKAGING 1539 01:02:49,520 --> 01:02:53,400 PROBLEMS, INCLUDING OF COURSE 1540 01:02:53,400 --> 01:03:02,680 PFOS, I WORK ON ASPRS WITH THE 1541 01:03:02,680 --> 01:03:04,240 ONTOX, RISK HUNTER, PRECISION 1542 01:03:04,240 --> 01:03:06,000 TOX, WE WERE TALKING YESTERDAY 1543 01:03:06,000 --> 01:03:07,280 WITH RISK HUNTER ON PARTNERSHIPS 1544 01:03:07,280 --> 01:03:10,120 THAT WE'RE GOING TO DO WITH 1545 01:03:10,120 --> 01:03:17,320 THEM, SPEAKING TO ONTOX TO TALK 1546 01:03:17,320 --> 01:03:19,200 ABOUT RAPID FRAMEWORK FOR 1547 01:03:19,200 --> 01:03:20,200 DEVELOPING CHEMICALS. 1548 01:03:20,200 --> 01:03:24,760 IF WE SEE SOMETHING WE WANT TO 1549 01:03:24,760 --> 01:03:29,160 USE A RAPID RESPONSE FRAMEWORK, 1550 01:03:29,160 --> 01:03:30,720 DEVELOPING THROUGH OSTP AS RAPID 1551 01:03:30,720 --> 01:03:41,480 FRAMEWORK AND MECHANIC MECHANIC 1552 01:03:41,480 --> 01:03:42,080 INFORMATION. 1553 01:03:42,080 --> 01:03:44,240 RIGHT NOW AOP FOR REGULATORS, 1554 01:03:44,240 --> 01:03:46,360 NICE LIBRARY OF DIFFERENT DATA, 1555 01:03:46,360 --> 01:03:48,000 BUT IF YOU PUT QUANTITATION IN 1556 01:03:48,000 --> 01:03:51,520 AND KNOW WHICH WAY IT GOES YOU 1557 01:03:51,520 --> 01:03:53,680 MAY HAVE A REGULATORY TOOL TO 1558 01:03:53,680 --> 01:03:55,240 USE LOOKING AT DIFFERENT 1559 01:03:55,240 --> 01:03:57,480 CHEMICALS, ONE THING WE'RE 1560 01:03:57,480 --> 01:03:57,800 EXPLORING. 1561 01:03:57,800 --> 01:03:59,320 AGAIN, PUTTING NOT ONLY SENIOR 1562 01:03:59,320 --> 01:04:01,000 PEOPLE BUT SOME JUNIOR PEOPLE ON 1563 01:04:01,000 --> 01:04:06,360 THAT TO WORK WITH EUROPEANS ON 1564 01:04:06,360 --> 01:04:06,560 THAT. 1565 01:04:06,560 --> 01:04:07,960 AND WE CONTINUE COMMUNICATION 1566 01:04:07,960 --> 01:04:09,160 LIKE TODAY, COMMUNICATE WHAT 1567 01:04:09,160 --> 01:04:09,760 WE'RE DOING. 1568 01:04:09,760 --> 01:04:12,200 WE'RE VERY HAPPEN TO MEET WITH 1569 01:04:12,200 --> 01:04:15,640 PEOPLE WHAT WE'RE DOING IN THE 1570 01:04:15,640 --> 01:04:17,240 FOOD INDUSTRY, ENCOURAGE 1571 01:04:17,240 --> 01:04:18,080 DIALOGUE, DISCUSSION, 1572 01:04:18,080 --> 01:04:19,000 PARTNERSHIPS, AND WE'RE 1573 01:04:19,000 --> 01:04:20,160 ENCOURAGING PEOPLE TO COME AND 1574 01:04:20,160 --> 01:04:21,160 TALK ABOUT METHODS. 1575 01:04:21,160 --> 01:04:23,360 I WILL TALK ABOUT -- I WASN'T 1576 01:04:23,360 --> 01:04:25,000 GOING TO MENTION DOG STUDIES BUT 1577 01:04:25,000 --> 01:04:28,280 WHAT WE DID SINCE IT WAS BROUGHT 1578 01:04:28,280 --> 01:04:34,840 UP BY EPA , THE ANTIQUATED RED 1579 01:04:34,840 --> 01:04:37,480 BOOK, HARD TO FIND ON THE WEB 1580 01:04:37,480 --> 01:04:38,960 FORTUNATELY, IT SUGGESTS FOR 1581 01:04:38,960 --> 01:04:40,960 DIRECT FOOD ADDITIVE YOU HAVE TO 1582 01:04:40,960 --> 01:04:43,800 DO RODENT AND NON-RODENT STUDY. 1583 01:04:43,800 --> 01:04:46,280 WE PULLED 160 -- HAVEN'T GOT AN 1584 01:04:46,280 --> 01:04:49,200 DOG STUDY SINCE 2018 BUT PULLED 1585 01:04:49,200 --> 01:04:50,600 160 DOG STUDIES WE DID RECEIVE 1586 01:04:50,600 --> 01:04:53,560 OVER THE COURSE OF OUR WHOLE 1587 01:04:53,560 --> 01:04:55,280 TIME AND LOOKED AT THEM. 1588 01:04:55,280 --> 01:05:01,200 WE PULLED OUT THE ONES THAT WE 1589 01:05:01,200 --> 01:05:03,920 SAID AN ADI ON, AND IF WE SET IT 1590 01:05:03,920 --> 01:05:06,720 ONLY ON RODENT STUDY WOULD HAVE 1591 01:05:06,720 --> 01:05:08,120 STILL APPROVED THAT PRODUCT. 1592 01:05:08,120 --> 01:05:11,720 IT LEFT ROOM TO SAY MAYBE WE CAN 1593 01:05:11,720 --> 01:05:13,160 PUT IN ALTERNATIVE INSTEAD OF 1594 01:05:13,160 --> 01:05:14,760 DOG STUDY, WE AREN'T EVEN 1595 01:05:14,760 --> 01:05:15,760 GETTING DOG STUDIES ANYMORE AND 1596 01:05:15,760 --> 01:05:18,520 WE DO HAVE A PAPER THAT'S 1597 01:05:18,520 --> 01:05:20,480 WRITTEN, LOST SOMEWHERE IN MY 1598 01:05:20,480 --> 01:05:22,360 E-MAILS, TRYING TO GET IT 1599 01:05:22,360 --> 01:05:24,200 PUBLISHED TO SAY, YES, THIS IS A 1600 01:05:24,200 --> 01:05:27,040 VERY GOOD PLACE TO PUT AN 1601 01:05:27,040 --> 01:05:33,160 ALTERNATIVE AND WE WELCOME IT. 1602 01:05:33,160 --> 01:05:35,360 SO, THAT WAS BACK ALSO -- WE 1603 01:05:35,360 --> 01:05:37,880 DEVELOPED -- LET ME SEE IF I CAN 1604 01:05:37,880 --> 01:05:42,040 GO BACK, A FOOD CHEMICAL, 1605 01:05:42,040 --> 01:05:44,320 PUBLIC/PRIVATE PARTNERSHIP FOR 1606 01:05:44,320 --> 01:05:45,680 WHAT -- AT LEAST USED BY FDA TO 1607 01:05:45,680 --> 01:05:48,040 PUT TOGETHER A GROUP OF PEOPLE 1608 01:05:48,040 --> 01:05:50,040 THAT TALK ABOUT SCIENCE, AND IT 1609 01:05:50,040 --> 01:05:53,320 HELPS US, YOU KNOW, IN THE FOOD 1610 01:05:53,320 --> 01:05:54,400 INDUSTRY, HELPS US WORK ON 1611 01:05:54,400 --> 01:05:56,400 ISSUES TOGETHER TO TALK TO 1612 01:05:56,400 --> 01:05:59,120 ISSUES OF ANYONE. 1613 01:05:59,120 --> 01:06:03,720 WE DO HAVE PUBLIC/PRIVATE 1614 01:06:03,720 --> 01:06:04,680 PARTNERSHIP, I-FISH AS CONVENER, 1615 01:06:04,680 --> 01:06:07,240 JUST PUT LENA ON IT. 1616 01:06:07,240 --> 01:06:09,520 ANOTHER WAY OF US -- GIVING US A 1617 01:06:09,520 --> 01:06:11,920 VALID WAY OF TALKING TO 1618 01:06:11,920 --> 01:06:14,240 STAKEHOLDERS, THERE'S 20 1619 01:06:14,240 --> 01:06:16,440 PUBLIC/PRIVATE PARTNERSHIPS IN 1620 01:06:16,440 --> 01:06:17,520 CDER, SEVERAL IN CDRH, VERY GOOD 1621 01:06:17,520 --> 01:06:21,040 HIGH SCHOOLS TO WORK WITH 1622 01:06:21,040 --> 01:06:25,520 EVERYBODY ON IT. 1623 01:06:25,520 --> 01:06:26,400 LEVERAGING RESEARCH, IDENTIFYING 1624 01:06:26,400 --> 01:06:27,720 WHAT GAPS WE WANT TO DO RESEARCH 1625 01:06:27,720 --> 01:06:27,920 ON. 1626 01:06:27,920 --> 01:06:29,800 THIS IS WHAT WE DO. 1627 01:06:29,800 --> 01:06:31,560 WE'RE RECOGNIZING IN OUR CENTER 1628 01:06:31,560 --> 01:06:33,200 AND HOPEFULLY THROUGHOUT FDA 1629 01:06:33,200 --> 01:06:35,720 THAT REGULATORS HAVE TO BE UP 1630 01:06:35,720 --> 01:06:38,040 FRONT IN NEW METHOD DEVELOPMENT. 1631 01:06:38,040 --> 01:06:40,720 WE LOOKED AT DEVELOPING GAPS. 1632 01:06:40,720 --> 01:06:43,120 CDER PUT OUT A PAPER A COUPLE 1633 01:06:43,120 --> 01:06:45,240 WEEKS AGO ON THEIR GAPS FOR WHAT 1634 01:06:45,240 --> 01:06:47,200 THEY NEED, AND WE ARE 1635 01:06:47,200 --> 01:06:51,000 CIRCULATING A LIST OF DRAFT GAPS 1636 01:06:51,000 --> 01:06:54,320 WHAT DATA WE NEED FOR FOOD, 1637 01:06:54,320 --> 01:06:56,160 INCLUDING COSMETICS, BOTANICAL, 1638 01:06:56,160 --> 01:06:58,600 ANYTHING WE REGULATE. 1639 01:06:58,600 --> 01:07:00,080 WE IDENTIFY GAPS, DELINEATE WHAT 1640 01:07:00,080 --> 01:07:03,040 TOOLS, AND WORK WITH OUR 1641 01:07:03,040 --> 01:07:05,120 RESEARCHERS OR RESEARCH PARTNERS 1642 01:07:05,120 --> 01:07:06,800 OUTSIDE OF THE AGENCY TO MAKE 1643 01:07:06,800 --> 01:07:08,640 SURE THAT WE DEVELOP A TOOL THAT 1644 01:07:08,640 --> 01:07:09,600 ANSWERS THOSE GAPS. 1645 01:07:09,600 --> 01:07:10,840 SO WE DON'T WANT TO DEVELOP 1646 01:07:10,840 --> 01:07:13,120 TOOLS AND TRY TO FIT THEM INTO A 1647 01:07:13,120 --> 01:07:13,720 REGULATORY PROGRAM. 1648 01:07:13,720 --> 01:07:15,880 WE WANT TO DEVELOP THE 1649 01:07:15,880 --> 01:07:17,840 REGULATORY GAPS AND HAVE THE 1650 01:07:17,840 --> 01:07:18,160 TOOLS. 1651 01:07:18,160 --> 01:07:19,360 I CAN'T GUARANTEE WE'RE ALWAYS 1652 01:07:19,360 --> 01:07:21,680 DOING THIS ON YOUR RESEARCH BUT 1653 01:07:21,680 --> 01:07:22,880 WE'RE TRYING. 1654 01:07:22,880 --> 01:07:28,440 WE DO THIS WITH NCTR. 1655 01:07:28,440 --> 01:07:30,960 THE LAST ONE IS OVERSIGHT BY 1656 01:07:30,960 --> 01:07:32,000 SENIOR MANAGEMENT. 1657 01:07:32,000 --> 01:07:34,160 WORKING AT FDA FOR A LONG TIME I 1658 01:07:34,160 --> 01:07:35,800 KNEW THAT IN THE PREDICTIVE 1659 01:07:35,800 --> 01:07:39,520 ROADMAP FOR FDA IF I DIDN'T PUT 1660 01:07:39,520 --> 01:07:41,000 IN SENIOR MANAGEMENT OVERSIGHT 1661 01:07:41,000 --> 01:07:42,600 IT MAY GO NOWHERE. 1662 01:07:42,600 --> 01:07:44,040 SO, IN THE PREDICTIVE ROADMAP 1663 01:07:44,040 --> 01:07:45,480 ACROSS THE AGENCY THEY HAVE TO 1664 01:07:45,480 --> 01:07:47,720 REPORT TO THE OFFICE OF CHIEF 1665 01:07:47,720 --> 01:07:49,400 SCIENTIST, AND WE HAVE TO REPORT 1666 01:07:49,400 --> 01:07:52,760 TO THE SENIOR MANAGEMENT IN THE 1667 01:07:52,760 --> 01:07:53,680 FOODS PROGRAM, INCLUDING 1668 01:07:53,680 --> 01:07:54,720 PROBABLY, I'M SURE YOU HEARD 1669 01:07:54,720 --> 01:07:58,120 ABOUT WHAT'S GOING IN THE FOODS 1670 01:07:58,120 --> 01:07:59,440 PROGRAM, THE NEW DEPUTY 1671 01:07:59,440 --> 01:08:00,640 COMMISSIONER FOR FOODS, WHEN 1672 01:08:00,640 --> 01:08:05,240 THAT PERSON COMES ON BOARD. 1673 01:08:05,240 --> 01:08:06,880 SO THAT EMPHASIZES THE 1674 01:08:06,880 --> 01:08:07,880 IMPORTANCE OF DEVELOPING THESE 1675 01:08:07,880 --> 01:08:09,520 PROGRAMS FOR THE FOODS PROGRAM 1676 01:08:09,520 --> 01:08:11,920 AND FOR ALL OF FDA BECAUSE ALL 1677 01:08:11,920 --> 01:08:13,560 OF THE CENTERS ARE REPORTING 1678 01:08:13,560 --> 01:08:15,200 BACK TO THE OFFICE OF THE 1679 01:08:15,200 --> 01:08:15,520 COMMISSIONER. 1680 01:08:15,520 --> 01:08:17,040 AND THEN OF COURSE WE WORK 1681 01:08:17,040 --> 01:08:23,520 ACROSS OUR CENTERS AS I'M 1682 01:08:23,520 --> 01:08:25,280 LOOKING AT SLIDES I SEE THINGS 1683 01:08:25,280 --> 01:08:27,240 WE CAN PARTNER WITH TOBACCO ON, 1684 01:08:27,240 --> 01:08:28,520 GIVING YOU CONFIDENCE THAT FDA 1685 01:08:28,520 --> 01:08:31,360 IS WORKING TOWARDS THIS GOAL OF 1686 01:08:31,360 --> 01:08:32,200 REPLACING ANIMAL STUDIES. 1687 01:08:32,200 --> 01:08:35,680 LIKE I SAID, WE DON'T HAVE ANY 1688 01:08:35,680 --> 01:08:42,440 ANIMALS IN OUR LAB ANYMORE, 1689 01:08:42,440 --> 01:08:44,760 EXCEPT FOR WORMS. 1690 01:08:44,760 --> 01:08:46,160 AND SO WE ENCOURAGE OUR 1691 01:08:46,160 --> 01:08:47,480 STAKEHOLDERS TO WORK WITH US. 1692 01:08:47,480 --> 01:08:51,200 THANK YOU FOR INVITING ME HERE 1693 01:08:51,200 --> 01:08:51,640 TODAY. 1694 01:08:51,640 --> 01:08:51,920 [APPLAUSE] 1695 01:08:51,920 --> 01:08:54,280 ANY QUESTIONS? 1696 01:08:54,280 --> 01:09:02,040 1697 01:09:02,040 --> 01:09:02,920 I'M OFF THE HOOK. 1698 01:09:02,920 --> 01:09:05,200 >> WE HAVE QUESTIONS IN THE 1699 01:09:05,200 --> 01:09:05,560 ROOM. 1700 01:09:05,560 --> 01:09:05,840 GO AHEAD. 1701 01:09:05,840 --> 01:09:06,640 >> THANKS, SUZIE. 1702 01:09:06,640 --> 01:09:11,680 LOTS OF GREAT WORK AS USUAL. 1703 01:09:11,680 --> 01:09:13,840 YOU MENTIONED MOUs AND CHIP 1704 01:09:13,840 --> 01:09:17,600 ABOUT AS GOOD AS OR BETTER 1705 01:09:17,600 --> 01:09:18,800 CRITERIA FOR VALIDATING AGAINST 1706 01:09:18,800 --> 01:09:24,440 MOUSE TEST. 1707 01:09:24,440 --> 01:09:25,240 IS THAT CRITERIA PUBLISHED? 1708 01:09:25,240 --> 01:09:26,320 >> IT WILL BE PUBLISHED. 1709 01:09:26,320 --> 01:09:27,480 WE'RE WORKING ON IT NOW. 1710 01:09:27,480 --> 01:09:28,720 EVERYTHING IS GOING TO BE 1711 01:09:28,720 --> 01:09:29,080 PUBLISHED. 1712 01:09:29,080 --> 01:09:36,160 ANYTHING THE GOVERNMENT DOES HAS 1713 01:09:36,160 --> 01:09:37,720 TO BE PUBLISHED. 1714 01:09:37,720 --> 01:09:40,120 WE WANT TO DO CASE STUDIES. 1715 01:09:40,120 --> 01:09:42,840 I WAS TALKING TO NICOLE ABOUT A 1716 01:09:42,840 --> 01:09:44,160 CASE STUDY TODAY. 1717 01:09:44,160 --> 01:09:47,640 ALL OF THESE GIVE US A WAY OF 1718 01:09:47,640 --> 01:09:49,400 TALKING TO PEOPLE LEGITIMATELY 1719 01:09:49,400 --> 01:09:50,200 WITHOUT SOMEONE CRITICIZING AND 1720 01:09:50,200 --> 01:09:51,400 SAYING YOU'RE TALKING TO THEM, 1721 01:09:51,400 --> 01:09:53,640 WHY AREN'T YOU TALKING TO ME. 1722 01:09:53,640 --> 01:09:55,800 LIKE YOU SEE WITH YOUR KIDS, WHY 1723 01:09:55,800 --> 01:09:58,200 DOES HE GET THIS AND I DON'T GET 1724 01:09:58,200 --> 01:09:59,200 THIS? 1725 01:09:59,200 --> 01:09:59,760 [LAUGHTER] 1726 01:09:59,760 --> 01:10:00,200 THE SAME THING. 1727 01:10:00,200 --> 01:10:01,000 >>OKAY. 1728 01:10:01,000 --> 01:10:02,280 >> WE'RE OPEN TO THESE 1729 01:10:02,280 --> 01:10:02,880 PARTNERSHIPS. 1730 01:10:02,880 --> 01:10:05,120 I'M ALWAYS LOOKING FOR 1731 01:10:05,120 --> 01:10:05,880 PARTNERSHIPS. 1732 01:10:05,880 --> 01:10:08,800 IT'S ONE OF MY JOBS. 1733 01:10:08,800 --> 01:10:09,400 >> ARE THOSE CRITERIA SIMILAR 1734 01:10:09,400 --> 01:10:17,040 TO WHAT I CAN VALUE -- ICCVAM IS 1735 01:10:17,040 --> 01:10:18,680 WORKING OR MORE DIRECT 1736 01:10:18,680 --> 01:10:19,000 VALIDATION? 1737 01:10:19,000 --> 01:10:20,640 >> IT'S A BIG QUESTION. 1738 01:10:20,640 --> 01:10:23,280 WHAT KIND OF CONCORDANT DATA WE 1739 01:10:23,280 --> 01:10:24,800 NEED, THAT'S A QUESTION THAT WE 1740 01:10:24,800 --> 01:10:27,520 NEED TO ANSWER, DO WE REALLY 1741 01:10:27,520 --> 01:10:29,920 NEED ANIMAL DATA, CONCORDANT 1742 01:10:29,920 --> 01:10:31,160 ANIMAL DATA, FOR EXAMPLE THAT'S 1743 01:10:31,160 --> 01:10:33,480 WHY WE'RE LOOKING AT 1744 01:10:33,480 --> 01:10:34,280 QUANTITATIVE ALPs, MAYBE WE 1745 01:10:34,280 --> 01:10:35,160 DON'T NEED THAT. 1746 01:10:35,160 --> 01:10:40,880 THAT'S ONE OF THE WORKSHOPS WE 1747 01:10:40,880 --> 01:10:42,640 SHOULD GET CONSENSUS ON, THROUGH 1748 01:10:42,640 --> 01:10:47,240 ICCVAM, A VERY GOOD TOOL TO GET 1749 01:10:47,240 --> 01:10:48,760 ALL THE AGENCIES TALKING 1750 01:10:48,760 --> 01:10:49,960 TOGETHER AND SUPPORTING EACH 1751 01:10:49,960 --> 01:10:53,600 OTHER ONE WE MAKE THESE 1752 01:10:53,600 --> 01:10:53,840 DECISIONS. 1753 01:10:53,840 --> 01:10:55,840 I'M NOT SURE WE NEED IT. 1754 01:10:55,840 --> 01:10:57,520 THERE'S SOME DISCUSSION AT FDA 1755 01:10:57,520 --> 01:11:01,360 DO WE NEED ANIMAL CHIPS TO DO 1756 01:11:01,360 --> 01:11:05,520 HUMAN CHIPS, DO WE NOT, HOW CAN 1757 01:11:05,520 --> 01:11:06,680 WE USE OTHER TOOLS. 1758 01:11:06,680 --> 01:11:08,440 WE WELCOME TALKING TO PEOPLE 1759 01:11:08,440 --> 01:11:11,200 ABOUT THEIR IDEAS. 1760 01:11:11,200 --> 01:11:13,920 THAT'S THE TOUGHEST AREA OF 1761 01:11:13,920 --> 01:11:17,520 QUALIFICATIONS, WHAT KIND OF 1762 01:11:17,520 --> 01:11:18,840 CONFIDENCE CAN YOU DEVELOP. 1763 01:11:18,840 --> 01:11:21,240 WE'RE OPEN TO COMMUNICATION ON 1764 01:11:21,240 --> 01:11:21,440 THAT. 1765 01:11:21,440 --> 01:11:23,440 >> THANKS, SUZIE. 1766 01:11:23,440 --> 01:11:23,880 >> ANYTHING ELSE? 1767 01:11:23,880 --> 01:11:25,760 >> THANKS, SUZIE. 1768 01:11:25,760 --> 01:11:27,600 JUST AS REMINDER CONTINUE TO 1769 01:11:27,600 --> 01:11:30,000 SEND QUESTIONS THROUGH THE 1770 01:11:30,000 --> 01:11:33,240 ICCVAM QUESTIONS E-MAIL. 1771 01:11:33,240 --> 01:11:37,440 SO NEXT PRESENTER IS PRESENTING 1772 01:11:37,440 --> 01:11:37,720 REMOTELY. 1773 01:11:37,720 --> 01:11:39,720 DR. DEANA HOLMES, WE CAN SEE 1774 01:11:39,720 --> 01:11:41,480 YOUR VIDEO, IF YOU CAN SHARE 1775 01:11:41,480 --> 01:11:52,080 YOUR SCREEN THAT WOULD BE GREAT 1776 01:11:57,280 --> 01:12:01,480 1777 01:12:01,480 --> 01:12:02,960 >> CAN YOU HEAR ME? 1778 01:12:02,960 --> 01:12:03,360 >> GREAT. 1779 01:12:03,360 --> 01:12:04,760 >> DO YOU SEE MY SCREEN? 1780 01:12:04,760 --> 01:12:07,840 >>NOT IN THE ROOM. 1781 01:12:07,840 --> 01:12:13,840 1782 01:12:13,840 --> 01:12:15,520 1783 01:12:15,520 --> 01:12:18,440 LET ME TRY AGAIN. 1784 01:12:18,440 --> 01:12:24,440 1785 01:12:24,440 --> 01:12:34,480 1786 01:12:55,040 --> 01:12:56,920 >> LOOKS LIKE IT'S WORKING. 1787 01:12:56,920 --> 01:13:01,760 YOU'RE ON YOUR SECOND SLIDE. 1788 01:13:01,760 --> 01:13:07,800 1789 01:13:07,800 --> 01:13:17,840 1790 01:13:20,520 --> 01:13:22,320 >> GOOD MORNING, EVERYONE. 1791 01:13:22,320 --> 01:13:28,600 I AM DEANA HOLMES. 1792 01:13:28,600 --> 01:13:31,520 THIS MORNING I'M GOING TO 1793 01:13:31,520 --> 01:13:34,720 PROVIDE A BRIEF UPDATE ON THE 1794 01:13:34,720 --> 01:13:35,360 NON-ANIMAL TESTING WORKING GROUP 1795 01:13:35,360 --> 01:13:45,880 AT THE SUBCOMMITTEE OF EXPERTS 1796 01:14:09,920 --> 01:14:10,160 ON THE GHS. 1797 01:14:10,160 --> 01:14:13,120 IN 2013 A WORKING PAPER WAS 1798 01:14:13,120 --> 01:14:23,640 SUBMITTED TO THE GHS PROPOSING 1799 01:14:29,040 --> 01:14:29,600 ESTABLISHMENT, PROPOSING SEVERAL 1800 01:14:29,600 --> 01:14:32,080 ACTIVITIES RELATED TO USE OF 1801 01:14:32,080 --> 01:14:35,120 NON-ANIMAL DATA SUCH AS IN 1802 01:14:35,120 --> 01:14:42,760 SILICO, IN VITRO, IN CHEMICO FOR 1803 01:14:42,760 --> 01:14:43,880 CLASSIFYING SUBSTANCES IN 1804 01:14:43,880 --> 01:14:44,360 MIXTURES. 1805 01:14:44,360 --> 01:14:47,320 USE OF A STEP WISE APPROACH, 1806 01:14:47,320 --> 01:14:51,440 WORKING GROUP AGREED TO BEGIN 1807 01:14:51,440 --> 01:14:53,960 WITH THE IRRITATION CHAPTER, TO 1808 01:14:53,960 --> 01:14:54,720 INCORPORATE NON-ANIMAL TEST 1809 01:14:54,720 --> 01:14:58,240 METHODS, AND THAT WORK WAG 1810 01:14:58,240 --> 01:15:02,080 COMPLETED IN 2019, UPDATE TO THE 1811 01:15:02,080 --> 01:15:03,160 CHAPTER, PUBLISHED IN GHS 1812 01:15:03,160 --> 01:15:05,040 REVISION 8. 1813 01:15:05,040 --> 01:15:06,920 WORKING GROUP UPDATED THE 1814 01:15:06,920 --> 01:15:10,080 IRRITATION CHAPTER AND THAT WORK 1815 01:15:10,080 --> 01:15:13,040 WAS COMPLETED IN 2021, UPDATES 1816 01:15:13,040 --> 01:15:23,480 WERE PUBLISHED IN THE 9th 1817 01:15:31,280 --> 01:15:36,840 REVISION, WORK WAS COMPLETED AT 1818 01:15:36,840 --> 01:15:39,000 THE END WAS COMPLETED DECEMBER 1819 01:15:39,000 --> 01:15:40,080 OF LAST YEAR. 1820 01:15:40,080 --> 01:15:41,840 PUBLISHED IN REVISION 10 OF THE 1821 01:15:41,840 --> 01:15:42,080 GHS. 1822 01:15:42,080 --> 01:15:46,000 WORKING GROUP IS STILL WORKING 1823 01:15:46,000 --> 01:15:47,200 ON MIXTURE CRITERIA, SKIN 1824 01:15:47,200 --> 01:15:49,280 SENSITIZATION, AND THAT WORK 1825 01:15:49,280 --> 01:15:53,360 SHOULD BE COMPLETED IN THIS 1826 01:15:53,360 --> 01:15:54,640 CURRENT BIENNIUM AND PUBLISHED 1827 01:15:54,640 --> 01:16:05,320 IN THE 11th REVISION OF GHS 1828 01:16:05,320 --> 01:16:08,560 AROUND 2025. 1829 01:16:08,560 --> 01:16:09,960 NOW, IN UPDATING SKIN 1830 01:16:09,960 --> 01:16:12,040 SENSITIZATION CHAPTER THE MAIN 1831 01:16:12,040 --> 01:16:15,800 OBJECTIVE WAS TO REVISE THE SKIN 1832 01:16:15,800 --> 01:16:18,400 SENSITIZATION CHAPTER TO BETTER 1833 01:16:18,400 --> 01:16:20,800 REFLECT INCREASED CAPABILITY, 1834 01:16:20,800 --> 01:16:23,000 AVAILABILITY, UTILITY FOR 1835 01:16:23,000 --> 01:16:24,960 CLASSIFICATION OF IN CHEMICO IN 1836 01:16:24,960 --> 01:16:28,040 VITRO TEST METHODS, DEFINED 1837 01:16:28,040 --> 01:16:29,880 APPROACHES, AND NON-TEST 1838 01:16:29,880 --> 01:16:37,640 METHODS, COMPUTER MODELS AND 1839 01:16:37,640 --> 01:16:38,200 READ ACROSS. 1840 01:16:38,200 --> 01:16:41,080 ONE OF THE KEY UPDATES WAS 1841 01:16:41,080 --> 01:16:43,480 INCLUDING A TIERED APPROACH TO 1842 01:16:43,480 --> 01:16:44,320 CLASSIFYING CHEMICALS, 1843 01:16:44,320 --> 01:16:46,720 INCORPORATED IN A SIMILAR 1844 01:16:46,720 --> 01:16:48,640 FASHION TO WHAT IS IN THE 1845 01:16:48,640 --> 01:16:53,160 CURRENT SKIN AND EYE CHAPTERS, 1846 01:16:53,160 --> 01:16:56,800 3.2 AND 3.3. 1847 01:16:56,800 --> 01:16:58,760 ALSO WEIGHT OF EVIDENCE 1848 01:16:58,760 --> 01:17:00,640 ASSESSMENT CAN BE APPLIED, AS 1849 01:17:00,640 --> 01:17:09,000 WELL AS OVERALL IF NO INDIVIDUAL 1850 01:17:09,000 --> 01:17:12,560 TIER RESULTS IN CLASSIFICATION. 1851 01:17:12,560 --> 01:17:16,080 THIS SLIDE SHOWS APPLICATION OF 1852 01:17:16,080 --> 01:17:18,040 TIERED APPROACH FOR SKIN 1853 01:17:18,040 --> 01:17:19,240 SENSITIZATION, STRUCTURE IS 1854 01:17:19,240 --> 01:17:21,320 BETTER DELINEATED IN THIS 1855 01:17:21,320 --> 01:17:22,920 UPDATE, AND PROVIDES ADDITIONAL 1856 01:17:22,920 --> 01:17:27,120 GUIDANCE ON HOW TO APPLY DEFINED 1857 01:17:27,120 --> 01:17:31,280 APPROACHES IN CHEMICO, IN VITRO, 1858 01:17:31,280 --> 01:17:34,120 AND NON-TEST METHODS DATA FOR 1859 01:17:34,120 --> 01:17:35,000 CLASSIFYING PURPOSES. 1860 01:17:35,000 --> 01:17:38,240 TIER 1 CLASSIFICATION IS BASED 1861 01:17:38,240 --> 01:17:40,440 ON HUMAN DATA. 1862 01:17:40,440 --> 01:17:42,640 STANDARD ANIMAL DATA WITH 1863 01:17:42,640 --> 01:17:46,040 ADDITION OF DEFINED APPROACHES 1864 01:17:46,040 --> 01:17:47,560 OR STAND-ALONE IN CHEMICO IN 1865 01:17:47,560 --> 01:17:50,400 VITRO METHODS. 1866 01:17:50,400 --> 01:17:53,600 IN ADDITION, TIER 2 NOW INCLUDES 1867 01:17:53,600 --> 01:17:54,720 CLASSIFICATION BASED ON 1868 01:17:54,720 --> 01:17:55,480 INCONCLUSIVE INFORMATION FROM 1869 01:17:55,480 --> 01:18:04,200 TIER 1 WITH ADDITION OF 1870 01:18:04,200 --> 01:18:05,880 NON-STAND-ALONE IN CHEMICO TEST 1871 01:18:05,880 --> 01:18:08,040 METHODS FROM DEFINED APPROACHES. 1872 01:18:08,040 --> 01:18:10,560 TIER 3 IS SIMILAR TO CURRENT 1873 01:18:10,560 --> 01:18:11,640 CHAPTER, CLASSIFICATION IS BASED 1874 01:18:11,640 --> 01:18:13,960 ON OVERALL WEIGHT OF EVIDENCE 1875 01:18:13,960 --> 01:18:18,760 ASSESSMENT BUT MAY INCLUDE SOME 1876 01:18:18,760 --> 01:18:20,160 ADDITIONAL INDICATORS. 1877 01:18:20,160 --> 01:18:24,120 IN ADDITION, IF LOWER TIER 2 1878 01:18:24,120 --> 01:18:24,920 SUGGESTS STRICTER CLASSIFICATION 1879 01:18:24,920 --> 01:18:26,640 AND THERE'S CONCERN OF 1880 01:18:26,640 --> 01:18:34,280 MISCLASSIFICATION YOU GO TO 1881 01:18:34,280 --> 01:18:41,000 TIER3, OTHERWISE CONCLUDE ON 1882 01:18:41,000 --> 01:18:42,760 HIGHEST CONCLUSIVE TIER. 1883 01:18:42,760 --> 01:18:49,720 IN LINE WITH CHAPTERS 3.3 AND 1884 01:18:49,720 --> 01:18:53,120 3.2, A NEW CHAPTER HOW TO 1885 01:18:53,120 --> 01:19:02,120 CLASSIFY SKIN 1886 01:19:02,120 --> 01:19:03,920 SENSITIZATIONATION, INCLUDING 1887 01:19:03,920 --> 01:19:05,800 COMPUTER MODELS, QUALITATIVE 1888 01:19:05,800 --> 01:19:08,000 STRUCTURE ACTIVITY 1889 01:19:08,000 --> 01:19:10,320 RELATIONSHIPS, AND QUANTITATIVE 1890 01:19:10,320 --> 01:19:11,400 STRUCTURE ACTIVITY 1891 01:19:11,400 --> 01:19:12,160 RELATIONSHIPS. 1892 01:19:12,160 --> 01:19:21,680 AS WELL AS READ-ACROSS USING 1893 01:19:21,680 --> 01:19:23,840 ANALOGUE AND CATEGORY 1894 01:19:23,840 --> 01:19:24,160 APPROACHES. 1895 01:19:24,160 --> 01:19:26,960 DEFINE APPROACHES CONSIST OF A 1896 01:19:26,960 --> 01:19:29,120 RULE-BASED COMBINATION OF DATA 1897 01:19:29,120 --> 01:19:32,920 OBTAINED FROM PRE-DEFINED SET OF 1898 01:19:32,920 --> 01:19:34,040 INFORMATION SOURCES. 1899 01:19:34,040 --> 01:19:36,800 AND IT IS RECOGNIZED THAT MOST 1900 01:19:36,800 --> 01:19:39,320 SINGLE NON-ANIMAL METHODS ARE 1901 01:19:39,320 --> 01:19:45,440 NOT ABLE TO REPLACE IN VIVO 1902 01:19:45,440 --> 01:19:47,080 METHODS, MOST REGULATORY 1903 01:19:47,080 --> 01:19:48,080 ENDPOINTS, THEREFORE DEFINED 1904 01:19:48,080 --> 01:19:50,240 APPROACHES CAN BE USEFUL 1905 01:19:50,240 --> 01:19:51,880 STRATEGIES AND COMBINING DATA 1906 01:19:51,880 --> 01:19:55,760 FOR CLASSIFYING SUBSTANCES AND 1907 01:19:55,760 --> 01:19:56,120 MIXTURE. 1908 01:19:56,120 --> 01:19:58,360 THE WORKING GROUP 3 SEVERAL 1909 01:19:58,360 --> 01:20:00,480 DEFINED APPROACHES HAVE BEEN 1910 01:20:00,480 --> 01:20:03,640 DEVELOPED FOR CLASSIFICATION FOR 1911 01:20:03,640 --> 01:20:05,600 SKIN SENSITIZATION ACCEPTED AT 1912 01:20:05,600 --> 01:20:08,240 THE NATIONAL LEVEL, VALIDATED 1913 01:20:08,240 --> 01:20:09,720 ACCORDING TO INTERNATIONAL 1914 01:20:09,720 --> 01:20:11,200 PROCEDURES, USE OF DEFINED 1915 01:20:11,200 --> 01:20:13,960 APPROACH GUIDELINES COULD BE 1916 01:20:13,960 --> 01:20:17,480 INCLUDED WITHIN TIERED APPROACH 1917 01:20:17,480 --> 01:20:22,360 FOR SKIN SENSITIZATION. 1918 01:20:22,360 --> 01:20:24,440 REGARDING CLASSIFICATION OF 1919 01:20:24,440 --> 01:20:25,400 MIXTURES, APPLICABILITY OF 1920 01:20:25,400 --> 01:20:26,960 NON-ANIMAL METHODS FOR THE 1921 01:20:26,960 --> 01:20:27,640 CLASSIFICATION OF MIXTURES BASED 1922 01:20:27,640 --> 01:20:31,120 ON DATA FOR THE WHOLE MIXTURE, 1923 01:20:31,120 --> 01:20:33,880 WAS DISCUSSED. 1924 01:20:33,880 --> 01:20:39,440 AS FOR OECD METHODS VALIDATION 1925 01:20:39,440 --> 01:20:42,920 IS LIMITED AND OECD EXPRESSED 1926 01:20:42,920 --> 01:20:45,000 UPFRONT CONSIDERATION COULD BE 1927 01:20:45,000 --> 01:20:48,760 GIVEN TO CONSIDERATION WHETHER 1928 01:20:48,760 --> 01:20:51,480 RESULTS WILL YIELD RESULTS 1929 01:20:51,480 --> 01:20:52,920 MEANINGFUL SCIENTIFICALLY. 1930 01:20:52,920 --> 01:20:54,880 SO GROUP IS CURRENTLY 1931 01:20:54,880 --> 01:20:58,600 CONSIDERING HOW TO INCORPORATE 1932 01:20:58,600 --> 01:21:01,560 RESULTS OF IN CHEMICO, IN VITRO, 1933 01:21:01,560 --> 01:21:03,720 DEFINED TESTING FOR MIXTURES 1934 01:21:03,720 --> 01:21:05,040 THAT DON'T CAST DOUBT ON THESE 1935 01:21:05,040 --> 01:21:05,480 METHODS. 1936 01:21:05,480 --> 01:21:08,240 THERE'S STILL A WORK IN WORK 1937 01:21:08,240 --> 01:21:09,320 HERE. 1938 01:21:09,320 --> 01:21:14,120 HOWEVER, THEY ARE EXPECTED TO 1939 01:21:14,120 --> 01:21:14,720 COMPLETE THIS WORK THIS 1940 01:21:14,720 --> 01:21:17,080 BIENNIUM. 1941 01:21:17,080 --> 01:21:22,120 1942 01:21:22,120 --> 01:21:25,600 WITH REGARD TO NEXT STEPS, 1943 01:21:25,600 --> 01:21:27,800 WORKING GROUP PLANS TO FURTHER 1944 01:21:27,800 --> 01:21:30,720 UPDATE CHAPTER 3.4 WITH FOCUS ON 1945 01:21:30,720 --> 01:21:34,240 NON-ANIMAL TEST METHODS FOR 1946 01:21:34,240 --> 01:21:34,800 RESPIRATORY SENSITIZATION. 1947 01:21:34,800 --> 01:21:44,280 HOWEVER THEY ARE HOLDING OFF ON 1948 01:21:44,280 --> 01:21:45,200 RECOMMENDATIONS, IT'S NOT 1949 01:21:45,200 --> 01:21:47,920 EXPECTED TO BE COMPLETED IN TIME 1950 01:21:47,920 --> 01:21:50,880 FOR WORKING GROUP TO INCORPORATE 1951 01:21:50,880 --> 01:21:53,840 DURING THIS CURRENT BIENNIUM. 1952 01:21:53,840 --> 01:21:56,440 HOWEVER, WORKING GROUP PLANS TO 1953 01:21:56,440 --> 01:21:59,160 CONTINUE UPDATING THE GHS TO 1954 01:21:59,160 --> 01:22:00,040 INCORPORATE NON-ANIMAL TEST 1955 01:22:00,040 --> 01:22:02,800 METHODS, AND ALL OF THE 1956 01:22:02,800 --> 01:22:05,080 CHAPTERS, WHERE APPROPRIATE, BUT 1957 01:22:05,080 --> 01:22:06,520 THEY ARE STILL EVALUATING WHAT 1958 01:22:06,520 --> 01:22:08,480 CHAPTER TO WORK ON NEXT. 1959 01:22:08,480 --> 01:22:13,440 SO THAT HASN'T BEEN DONE YET OR 1960 01:22:13,440 --> 01:22:16,120 HASN'T BEEN DECIDED YET. 1961 01:22:16,120 --> 01:22:19,880 1962 01:22:19,880 --> 01:22:22,080 SO THAT CONCLUDES MY 1963 01:22:22,080 --> 01:22:23,800 PRESENTATION FOR THIS MORNING. 1964 01:22:23,800 --> 01:22:27,120 BEFORE I END, I DO WANT TO ADD I 1965 01:22:27,120 --> 01:22:29,320 HAVE PROVIDED MY E-MAIL ADDRESS 1966 01:22:29,320 --> 01:22:33,240 HERE, AS WELL AS MY COLLEAGUE 1967 01:22:33,240 --> 01:22:35,760 JANET CARTER, HEAD OF DELEGATION 1968 01:22:35,760 --> 01:22:40,600 FOR U.S. ON GHS SUBCOMMITTEE WHO 1969 01:22:40,600 --> 01:22:42,000 HAS BEEN EXTREMELY ACTIVE IN 1970 01:22:42,000 --> 01:22:44,640 THIS WORKING GROUP AND HAS BEEN 1971 01:22:44,640 --> 01:22:46,600 INSTRUMENTAL IN DEVELOPING THE 1972 01:22:46,600 --> 01:22:49,080 UPDATES TO THE SKIN 1973 01:22:49,080 --> 01:22:49,800 SENSITIZATION CHAPTER. 1974 01:22:49,800 --> 01:22:54,400 SO, IF YOU DO HAVE SPECIFIC 1975 01:22:54,400 --> 01:22:59,160 COMMENTS OR QUESTIONS, FEEL FREE 1976 01:22:59,160 --> 01:23:00,600 TO E-MAIL JANET DIRECTLY OR OF 1977 01:23:00,600 --> 01:23:03,360 COURSE YOU CAN CONTACT ME AS 1978 01:23:03,360 --> 01:23:03,560 WELL. 1979 01:23:03,560 --> 01:23:10,000 THANK YOU. 1980 01:23:10,000 --> 01:23:10,280 [APPLAUSE] 1981 01:23:10,280 --> 01:23:17,040 >> THANK YOU VERY MUCH, DEANA, 1982 01:23:17,040 --> 01:23:18,440 A GREAT PRESENTATION. 1983 01:23:18,440 --> 01:23:20,480 WE HAVE A DISRUPTION IN AGENDA, 1984 01:23:20,480 --> 01:23:22,040 OUR COLLEAGUE FROM THE V.A. 1985 01:23:22,040 --> 01:23:23,360 OFFICE OF RESEARCH AND 1986 01:23:23,360 --> 01:23:24,880 DEVELOPMENT WAS NOT ABLE TO JOIN 1987 01:23:24,880 --> 01:23:25,760 US YET. 1988 01:23:25,760 --> 01:23:29,040 WE'RE STILL HOPING THAT THEY MAY 1989 01:23:29,040 --> 01:23:30,800 JOIN US LATER, BUT FOR NOW WHAT 1990 01:23:30,800 --> 01:23:36,560 WE'RE GOING TO DO IS WE'RE GOING 1991 01:23:36,560 --> 01:23:42,280 TO TAKE SOME QUESTIONS FOR SOME 1992 01:23:42,280 --> 01:23:44,400 PREVIOUS PRESENTERS. 1993 01:23:44,400 --> 01:23:47,240 ACTUALLY, DO YOU MIND? 1994 01:23:47,240 --> 01:23:48,440 (INAUDIBLE) OKAY, GREAT. 1995 01:23:48,440 --> 01:23:53,120 SO, WE HAVE A COUPLE QUESTIONS 1996 01:23:53,120 --> 01:23:54,320 ONLINE IN THE INTERIM. 1997 01:23:54,320 --> 01:23:55,960 DAVE, DO YOU WANT TO TAKE SNOWS. 1998 01:23:55,960 --> 01:23:57,600 >>FIRST IS ADDRESSED TO JOHN 1999 01:23:57,600 --> 01:23:59,240 BUT EITHER JOHN OR SUZIE COULD 2000 01:23:59,240 --> 01:24:01,440 ANSWER THIS. 2001 01:24:01,440 --> 01:24:02,720 HOW DOES CPSC AND FDA 2002 01:24:02,720 --> 01:24:04,720 COMMUNICATE ABOUT ANY METHOD 2003 01:24:04,720 --> 01:24:06,000 VALIDATIONS SO EVENTUALLY THOSE 2004 01:24:06,000 --> 01:24:13,280 VALIDATED METHODS CAN BE USED BY 2005 01:24:13,280 --> 01:24:13,680 FDA REVIEWERS? 2006 01:24:13,680 --> 01:24:16,520 >> JOHN, DO YOU WANT FIRST PASS 2007 01:24:16,520 --> 01:24:19,200 AT THAT? 2008 01:24:19,200 --> 01:24:19,400 2009 01:24:19,400 --> 01:24:21,240 >> WELL, I DON'T KNOW THAT WE 2010 01:24:21,240 --> 01:24:22,360 HAVE ANY FORMAL MEETINGS WITH 2011 01:24:22,360 --> 01:24:28,040 FDA ABOUT THIS BUT WE DO MEET 2012 01:24:28,040 --> 01:24:30,040 ANNUALLY ABOUT THE METHOD 2013 01:24:30,040 --> 01:24:31,080 ACCEPTANCE AND SUZIE AND I TALK 2014 01:24:31,080 --> 01:24:33,960 AT LEAST ONCE A MONTH AT OUR 2015 01:24:33,960 --> 01:24:39,400 ICCVAM MEETINGS, WE ARE UP ON 2016 01:24:39,400 --> 01:24:41,280 EACH OTHER'S VALIDATION, MAYBE 2017 01:24:41,280 --> 01:24:42,600 BETTER TO COORDINATE BETTER 2018 01:24:42,600 --> 01:24:45,120 SINCE LIKE I SAID BEFORE THE 2019 01:24:45,120 --> 01:24:47,000 MEDICAL DEVICE FOR FDA IS ON A 2020 01:24:47,000 --> 01:24:50,240 PRACTICAL LEVEL VERY SIMILAR TO 2021 01:24:50,240 --> 01:24:53,040 WHAT CPSC LOOKS AT, PRODUCTS ARE 2022 01:24:53,040 --> 01:24:53,880 METAL, PLASTIC, RUBBER, SO WE'RE 2023 01:24:53,880 --> 01:24:56,640 GOING TO BE LOOKING AT THOSE 2024 01:24:56,640 --> 01:25:00,000 PRODUCTS SIMILARLY IN OUR 2025 01:25:00,000 --> 01:25:01,000 TOXICITY REVIEWS. 2026 01:25:01,000 --> 01:25:03,080 SO, YEAH, WE COULD PROBABLY SET 2027 01:25:03,080 --> 01:25:05,880 UP SOMETHING MORE FORMAL IN OUR 2028 01:25:05,880 --> 01:25:07,320 EXCHANGES OF IDEAS BUT, YEAH, 2029 01:25:07,320 --> 01:25:09,320 ONCE A MONTH AT THE ICCVAM 2030 01:25:09,320 --> 01:25:11,360 MEETING WE ALWAYS BRING UP IDEAS 2031 01:25:11,360 --> 01:25:15,960 TO ONE ANOTHER. 2032 01:25:15,960 --> 01:25:17,760 SO WE ARE COMMUNICATING THOSE 2033 01:25:17,760 --> 01:25:17,960 IDEAS. 2034 01:25:17,960 --> 01:25:18,200 >> OKAY. 2035 01:25:18,200 --> 01:25:24,040 THE NEXT QUESTION IS FROM AMY 2036 01:25:24,040 --> 01:25:25,800 KYLE, UC-BERKLEY, ANY REPS COULD 2037 01:25:25,800 --> 01:25:26,160 ADDRESS. 2038 01:25:26,160 --> 01:25:28,320 HAS EPA OR ANYONE ELSE USED ANY 2039 01:25:28,320 --> 01:25:30,440 NAMs METHODS TO BETTER ASSESS 2040 01:25:30,440 --> 01:25:31,840 COMBINATIONS OF PESTICIDES THAT 2041 01:25:31,840 --> 01:25:34,320 FARM WORKERS OR COMMUNITY 2042 01:25:34,320 --> 01:25:35,560 RESIDENTS ARE EXPOSED TO? 2043 01:25:35,560 --> 01:25:36,680 CONCERNS PEOPLE ARE NOT EXPOSED 2044 01:25:36,680 --> 01:25:39,520 ONLY ONE PESTICIDE AT A TIME BUT 2045 01:25:39,520 --> 01:25:40,800 SEVERAL, AND TESTING AND 2046 01:25:40,800 --> 01:25:42,200 ASSESSMENT STRUCTURE DOES NOT 2047 01:25:42,200 --> 01:25:43,520 ADDRESS THIS VERY WELL, IF AT 2048 01:25:43,520 --> 01:25:45,840 ALL. 2049 01:25:45,840 --> 01:25:47,240 >> MONIQUE, WOULD YOU LIKE TO 2050 01:25:47,240 --> 01:25:50,840 TRY AND ADDRESS THAT QUESTION? 2051 01:25:50,840 --> 01:25:56,880 2052 01:25:56,880 --> 01:25:57,400 2053 01:25:57,400 --> 01:26:00,200 >> THANK YOU FOR THE QUESTION. 2054 01:26:00,200 --> 01:26:03,560 YEAH, MIXTURES AND FORMULATIONS 2055 01:26:03,560 --> 01:26:05,520 ARE ALWAYS A CHALLENGE, 2056 01:26:05,520 --> 01:26:07,480 ESPECIALLY BECAUSE ONCE A 2057 01:26:07,480 --> 01:26:10,480 FORMULATION IS SPRAYED, THAT 2058 01:26:10,480 --> 01:26:11,080 FORMULATION CHANGES ALMOST 2059 01:26:11,080 --> 01:26:12,080 IMMEDIATELY IN THE ENVIRONMENT 2060 01:26:12,080 --> 01:26:14,720 AND THIN CONTINUES TO CHANGE AS 2061 01:26:14,720 --> 01:26:17,000 IT CONTINUES TO DEGRADE AND SO I 2062 01:26:17,000 --> 01:26:21,080 ACTUALLY THINK OF NAMs AS A 2063 01:26:21,080 --> 01:26:24,120 SPACE, HAS A LOT OF OPPORTUNITY 2064 01:26:24,120 --> 01:26:25,680 TO ACTUALLY ADDRESS A LOT OF THE 2065 01:26:25,680 --> 01:26:26,560 CHALLENGES AND LIMITATIONS THAT 2066 01:26:26,560 --> 01:26:30,080 WE HAVE WITH TESTING MIXTURES 2067 01:26:30,080 --> 01:26:33,120 AND FORMULATIONS BECAUSE OF THE 2068 01:26:33,120 --> 01:26:33,920 HIGH-THROUGHPUT TESTING AND 2069 01:26:33,920 --> 01:26:35,520 ABILITY TO WORK THROUGH THE 2070 01:26:35,520 --> 01:26:36,280 DIFFERENT COMPONENTS AND THINGS 2071 01:26:36,280 --> 01:26:39,360 LIKE THAT SO I ACTUALLY SEE 2072 01:26:39,360 --> 01:26:40,680 NAMs AS HAVING THAT POTENTIAL. 2073 01:26:40,680 --> 01:26:46,040 I THINK WE HAVE TO WORK TOWARDS 2074 01:26:46,040 --> 01:26:49,200 THAT OBVIOUSLY. 2075 01:26:49,200 --> 01:26:49,560 BUT YEAH. 2076 01:26:49,560 --> 01:26:52,040 >> I'LL JUST ADD THERE'S A LOT 2077 01:26:52,040 --> 01:26:55,440 OF OPPORTUNITY HERE FOR WORKING 2078 01:26:55,440 --> 01:26:58,040 WITH EXPOSURE AND BIOMONITORING 2079 01:26:58,040 --> 01:27:00,160 STUDIES TO BETTER IDENTIFY WHAT 2080 01:27:00,160 --> 01:27:02,560 WORKERS ARE BEING EXPOSED TO. 2081 01:27:02,560 --> 01:27:05,000 AND THEN DESIGN STUDIES THAT CAN 2082 01:27:05,000 --> 01:27:07,640 MORE ACCURATELY REFLECT REAL 2083 01:27:07,640 --> 01:27:08,880 WORLD EXPOSURE CONDITIONS, BASED 2084 01:27:08,880 --> 01:27:10,640 ON THAT DATA AND BASED ON 2085 01:27:10,640 --> 01:27:12,840 PREDICTION MODELS THAT ARE 2086 01:27:12,840 --> 01:27:14,480 TRAINED OFF OF BIOMONITORING 2087 01:27:14,480 --> 01:27:14,840 DATA. 2088 01:27:14,840 --> 01:27:17,320 AND SO NICEATM HAS BEEN WORKING 2089 01:27:17,320 --> 01:27:20,840 WITH EPA NOT ONLY OFFICE OF 2090 01:27:20,840 --> 01:27:23,320 PESTICIDE PROGRAMS AND OPPT, 2091 01:27:23,320 --> 01:27:26,160 WITH ORD AND EXPO CAST MODELS TO 2092 01:27:26,160 --> 01:27:27,960 INTEGRATE EXPOSURE DATA FROM 2093 01:27:27,960 --> 01:27:29,760 BIOMONITORING PERSPECTIVE AND 2094 01:27:29,760 --> 01:27:31,200 FROM A PREDICTIVE MODELING 2095 01:27:31,200 --> 01:27:33,080 PERSPECTIVE INTO A LOT OF OUR 2096 01:27:33,080 --> 01:27:34,280 COMPUTATIONAL TOOLS AND SO ONCE 2097 01:27:34,280 --> 01:27:36,920 WE HAVE A BETTER HANDLE ON 2098 01:27:36,920 --> 01:27:38,120 VARIOUS EXPOSURE SCENARIOS WE 2099 01:27:38,120 --> 01:27:39,560 CAN START TO DESIGN BETTER 2100 01:27:39,560 --> 01:27:44,480 NAMs STUDIES TO ADDRESS THOSE. 2101 01:27:44,480 --> 01:27:51,800 SUZIE, DID YOU WANT TO ADDRESS 2102 01:27:51,800 --> 01:27:52,000 THAT? 2103 01:27:52,000 --> 01:27:54,000 >> FOOD IS A MIXTURE. 2104 01:27:54,000 --> 01:27:54,880 SO MIXTURES ARE VERY IMPORTANT 2105 01:27:54,880 --> 01:27:55,960 TO US. 2106 01:27:55,960 --> 01:27:58,840 YOU JUST DON'T EAT ONE THING. 2107 01:27:58,840 --> 01:28:00,920 THAT'S WHERE WE WOULD BE EXCITED 2108 01:28:00,920 --> 01:28:03,520 TO WORK WITH ICCVAM, ANY 2109 01:28:03,520 --> 01:28:05,160 PARTNERS ON MIXTURES, AND HOW DO 2110 01:28:05,160 --> 01:28:06,040 USE NAMs. 2111 01:28:06,040 --> 01:28:07,600 WE RECOGNIZE WE'RE NOT GOING TO 2112 01:28:07,600 --> 01:28:08,880 DO ANIMAL STUDIES ON EVERY 2113 01:28:08,880 --> 01:28:10,000 MIXTURE WE HAVE. 2114 01:28:10,000 --> 01:28:11,080 WE NEED NEW APPROACH METHODS TO 2115 01:28:11,080 --> 01:28:12,800 LOOK AT IT. 2116 01:28:12,800 --> 01:28:14,600 WE'RE LOOKING AT A GLOBAL LEVEL. 2117 01:28:14,600 --> 01:28:16,800 I THINK THAT'S A VERY IMPORTANT 2118 01:28:16,800 --> 01:28:17,080 AREA. 2119 01:28:17,080 --> 01:28:22,920 WHAT WAS THE QUESTION BEFORE? 2120 01:28:22,920 --> 01:28:24,880 DID WE WORK WITH -- I'M DONE? 2121 01:28:24,880 --> 01:28:26,440 >> NO, YOU'RE NOT. 2122 01:28:26,440 --> 01:28:27,200 ONE LAST QUESTION. 2123 01:28:27,200 --> 01:28:30,280 THIS IS ALSO FOR SUZIE FROM 2124 01:28:30,280 --> 01:28:31,680 ELIZABETH BECKER. 2125 01:28:31,680 --> 01:28:33,560 IN ADDITION TO AGENCY-WIDE 2126 01:28:33,560 --> 01:28:35,080 ADVANCING ALTERNATIVE METHODS 2127 01:28:35,080 --> 01:28:36,720 WORK GROUP, YOU MENTIONED CFSAN 2128 01:28:36,720 --> 01:28:39,000 HAS ITS OWN NAMs WORK GROUP. 2129 01:28:39,000 --> 01:28:40,600 COULD YOU COMMENT ON WHETHER 2130 01:28:40,600 --> 01:28:43,960 OTHER CENTERS HAVE ALSO 2131 01:28:43,960 --> 01:28:45,920 ESTABLISHED CENTER-SPECIFIC 2132 01:28:45,920 --> 01:28:46,360 NAMs WORK GROUPS? 2133 01:28:46,360 --> 01:28:48,640 >> I KNOW THEY WERE ASKED TO. 2134 01:28:48,640 --> 01:28:52,600 YOU ALREADY KNOW THAT WE HAVE 2135 01:28:52,600 --> 01:28:56,760 A -- CDER WORKS ON ICH, PARTLY 2136 01:28:56,760 --> 01:28:59,160 NAMs, THEY HAVE I-STAND, 2137 01:28:59,160 --> 01:29:01,040 BIOMARKER DDT PROGRAM, YOU HEARD 2138 01:29:01,040 --> 01:29:07,720 FROM JOHN ABOUT THE MEDICAL 2139 01:29:07,720 --> 01:29:09,000 DEVICE TOOL PROGRAM, WE HAVE A 2140 01:29:09,000 --> 01:29:11,840 PROGRAM, VET DRUGS IS WORKING ON 2141 01:29:11,840 --> 01:29:13,800 IT, CTP IS GOING TO TALK ABOUT 2142 01:29:13,800 --> 01:29:16,360 WHAT THEY ARE DOING. 2143 01:29:16,360 --> 01:29:19,960 I WAS SURPRISED LOOKING AT LUIS, 2144 01:29:19,960 --> 01:29:21,240 HOW MANY EXCITING THINGS. 2145 01:29:21,240 --> 01:29:23,000 WE'RE LOOKING ACROSS THE AGENCY, 2146 01:29:23,000 --> 01:29:24,440 ALSO THE COMMISSION, WHAT 2147 01:29:24,440 --> 01:29:27,280 EVERYBODY IS DOING ON NAMs, SO 2148 01:29:27,280 --> 01:29:29,040 WE SURVEYED ALL OF US, TRYING TO 2149 01:29:29,040 --> 01:29:30,680 WORK TOGETHER, AND THAT'S WHAT 2150 01:29:30,680 --> 01:29:31,880 OUR ALTERNATIVE METHODS WORK 2151 01:29:31,880 --> 01:29:33,520 GROUP DOES, THAT DONNA AND I 2152 01:29:33,520 --> 01:29:37,440 CHAIR, AND WE HAVE ON THAT ONE 2153 01:29:37,440 --> 01:29:41,960 NOT ONLY SENIOR PEOPLE ACROSS 2154 01:29:41,960 --> 01:29:45,960 AGENCY, REPRESENTATIVES FROM OUR 2155 01:29:45,960 --> 01:29:48,800 FIELD, NCTR, AND THEN TO JOHN'S 2156 01:29:48,800 --> 01:29:51,120 POINT UNDER THE CONTAMINANTS OF 2157 01:29:51,120 --> 01:29:53,200 EMERGING CONCERN, PART OF THAT 2158 01:29:53,200 --> 01:29:56,480 WE'RE LOOKING AT HOW WE WORK 2159 01:29:56,480 --> 01:29:57,440 CROSS-AGENCY ON SOME PROJECTS. 2160 01:29:57,440 --> 01:30:00,200 YOUR GROUP IS INVOLVED IN THAT I 2161 01:30:00,200 --> 01:30:02,480 THINK, CARLOS OR -- WE JUST -- 2162 01:30:02,480 --> 01:30:04,360 YOU KNOW, EVERY FEDERAL AGENCY 2163 01:30:04,360 --> 01:30:06,080 HAS WORKED ON THIS CROSS-AGENCY, 2164 01:30:06,080 --> 01:30:07,320 HOW CAN WE ADDRESS SOME OF THESE 2165 01:30:07,320 --> 01:30:08,880 PROBLEMS, THIS IS AN INITIATIVE 2166 01:30:08,880 --> 01:30:09,600 WE'RE GETTING OUT OF THE WHITE 2167 01:30:09,600 --> 01:30:11,200 HOUSE SO I THINK YOU'RE GOING TO 2168 01:30:11,200 --> 01:30:14,320 SEE A LOT MORE OF COMMUNICATION 2169 01:30:14,320 --> 01:30:15,520 INSIDE THE FEDERAL GOVERNMENT 2170 01:30:15,520 --> 01:30:17,360 AND OUTSIDE THE FEDERAL 2171 01:30:17,360 --> 01:30:20,160 GOVERNMENT ON A LOT OF THESE 2172 01:30:20,160 --> 01:30:22,840 PROGRAMS. 2173 01:30:22,840 --> 01:30:23,600 >> THANKS, SUZIE. 2174 01:30:23,600 --> 01:30:24,920 WE HAD A QUESTION IN THE ROOM 2175 01:30:24,920 --> 01:30:26,000 EARLIER THAT WE DIDN'T GET TO. 2176 01:30:26,000 --> 01:30:29,000 DID YOU WANT TO ASK A QUESTION 2177 01:30:29,000 --> 01:30:29,480 NOW OR -- 2178 01:30:29,480 --> 01:30:39,560 >>SURE, IF WE HAVE TIME. 2179 01:30:39,560 --> 01:30:42,120 >> OKAY. 2180 01:30:42,120 --> 01:30:43,520 2181 01:30:43,520 --> 01:30:46,800 >> YEAH, SORRY. 2182 01:30:46,800 --> 01:30:52,280 I WAS CURIOUS TO SEE IN TERMS OF 2183 01:30:52,280 --> 01:30:55,360 BIOTECH PRODUCTS LIKE GMOs, 2184 01:30:55,360 --> 01:30:55,680 GENE EDITING. 2185 01:30:55,680 --> 01:30:59,000 >> YOU WANT TO KNOW WHAT'S 2186 01:30:59,000 --> 01:30:59,520 GOING ON? 2187 01:30:59,520 --> 01:31:06,480 >> YEAH, IF YOU HAVE -- 2188 01:31:06,480 --> 01:31:10,240 >>I MEAN, WE DO DO GMO FOODS. 2189 01:31:10,240 --> 01:31:10,560 >> RIGHT. 2190 01:31:10,560 --> 01:31:12,480 >> IT'S DIVIDED BETWEEN WHAT 2191 01:31:12,480 --> 01:31:15,600 USDA IS RESPONSIBLE FOR AND WHAT 2192 01:31:15,600 --> 01:31:17,480 CFSAN IS RESPONSIBLE FOR. 2193 01:31:17,480 --> 01:31:19,880 GMOS, THEY CAN COME IN WITH A 2194 01:31:19,880 --> 01:31:21,760 CONSULTATION ON WHAT WE'RE DOING 2195 01:31:21,760 --> 01:31:22,800 ON THAT. 2196 01:31:22,800 --> 01:31:26,640 AND THAT'S -- I THINK IT WOULD 2197 01:31:26,640 --> 01:31:30,400 BE A BIGGER PART, CFSAN AND 2198 01:31:30,400 --> 01:31:34,000 FOODS PROGRAM IS UNDERGOING A 2199 01:31:34,000 --> 01:31:34,840 REORGANIZATION AND THERE MIGHT 2200 01:31:34,840 --> 01:31:36,720 BE AN OFFICE OF SPECIAL FOODS, 2201 01:31:36,720 --> 01:31:39,360 THAT MIGHT COME UNDER THAT. 2202 01:31:39,360 --> 01:31:41,320 SO, SPECIAL FOOD THING. 2203 01:31:41,320 --> 01:31:45,280 SO IT IS SOMETHING THAT WE'RE 2204 01:31:45,280 --> 01:31:46,480 WORKING ON, AND WORK A LOT WITH 2205 01:31:46,480 --> 01:31:48,520 THE FOOD INDUSTRY ON THAT TOO 2206 01:31:48,520 --> 01:31:50,520 SO -- I HOPE THAT ANSWERS YOU. 2207 01:31:50,520 --> 01:31:52,800 >> YEAH. 2208 01:31:52,800 --> 01:31:54,560 >> OKAY. 2209 01:31:54,560 --> 01:31:55,560 THANKS, SUZIE. 2210 01:31:55,560 --> 01:31:58,440 WE'VE HAD A NUMBER OF QUESTIONS 2211 01:31:58,440 --> 01:32:00,800 OF INTEREST ACCESS TO THE SLIDES 2212 01:32:00,800 --> 01:32:03,000 AND VIDEO, AND SO WE CAN ADD 2213 01:32:03,000 --> 01:32:04,200 THESE DETAILS ON THE BREAK 2214 01:32:04,200 --> 01:32:05,800 SLIDE, BUT WE EXPECT A VIDEO 2215 01:32:05,800 --> 01:32:10,840 FROM THE MEETING TO BE POSTED ON 2216 01:32:10,840 --> 01:32:12,480 PAST EVENTS PAGE OF NIH 2217 01:32:12,480 --> 01:32:14,240 VIDEOCAST IN A WEEK OR SO, WE'LL 2218 01:32:14,240 --> 01:32:16,000 PUT A LINK ON THE MEETING WEB 2219 01:32:16,000 --> 01:32:17,960 PAGE ON THE NICEATM WEBSITE WHEN 2220 01:32:17,960 --> 01:32:18,960 IT'S AVAILABLE. 2221 01:32:18,960 --> 01:32:21,120 WE'LL BE POSTING THE SLIDES 2222 01:32:21,120 --> 01:32:23,520 PRESENTED TODAY AT A WEB PAGE 2223 01:32:23,520 --> 01:32:25,120 DEDICATED TO THIS MEETING WHEN 2224 01:32:25,120 --> 01:32:27,600 MADE COMPLIANT WITH GOVERNMENT 2225 01:32:27,600 --> 01:32:29,280 ACCESSIBILITY REQUIREMENTS, 2226 01:32:29,280 --> 01:32:33,840 PROBABLY IN MID-JUNE. 2227 01:32:33,840 --> 01:32:35,480 REGISTRANTS WILL BE NOTIFIED BY 2228 01:32:35,480 --> 01:32:38,360 E-MAIL WHEN THINGS ARE POSTED ON 2229 01:32:38,360 --> 01:32:39,200 THE WEB PAGE. 2230 01:32:39,200 --> 01:32:42,440 >> WE HAVE A SLIGHT CHANGE IN 2231 01:32:42,440 --> 01:32:43,840 THE AGENDA. 2232 01:32:43,840 --> 01:32:45,640 OUR DOI COLLEAGUE HAS GRACIOUSLY 2233 01:32:45,640 --> 01:32:47,880 AGREED TO MOVE UP INTO THIS 2234 01:32:47,880 --> 01:32:49,680 PRESENTATION SLOT FROM HER SLOT 2235 01:32:49,680 --> 01:32:51,880 AFTER LUNCH, SO NOW WE'LL BE 2236 01:32:51,880 --> 01:32:58,040 HEARING ABOUT THE DEPARTMENT OF 2237 01:32:58,040 --> 01:33:00,880 INTERIOR ALTERNATIVE APPROACHES, 2238 01:33:00,880 --> 01:33:02,200 SO JESSICA, OVER TO YOU. 2239 01:33:02,200 --> 01:33:07,320 >> THANK YOU VERY MUCH. 2240 01:33:07,320 --> 01:33:09,960 I'M JESSICA LEET, LOCATED AT 2241 01:33:09,960 --> 01:33:11,920 COLUMBIA ENVIRONMENTAL RESEARCH 2242 01:33:11,920 --> 01:33:14,440 CENTER, RESEARCH TOXICOLOGIST 2243 01:33:14,440 --> 01:33:17,160 WITH USGS WITHIN DOI. 2244 01:33:17,160 --> 01:33:19,240 I'M THE ALTERNATE REP, BARNETT 2245 01:33:19,240 --> 01:33:21,560 BRATNER COULDN'T BE HERE BUT I'M 2246 01:33:21,560 --> 01:33:24,280 HAPPY TO REPRESENT THE UPDATE 2247 01:33:24,280 --> 01:33:24,880 FOR DOI. 2248 01:33:24,880 --> 01:33:29,120 WE LIKE TO THROW THIS UP AS A 2249 01:33:29,120 --> 01:33:30,920 REMINDER OF HOW DOI IS A BIT 2250 01:33:30,920 --> 01:33:32,520 DIFFERENT THAN THE OTHER 2251 01:33:32,520 --> 01:33:34,920 AGENCIES THAT TYPICALLY DO AN 2252 01:33:34,920 --> 01:33:36,000 UPDATE FOR ICCVAM. 2253 01:33:36,000 --> 01:33:37,760 WE'RE NOT A REGULATORY AGENCY. 2254 01:33:37,760 --> 01:33:41,000 WE HAVE VERY LITTLE REGULATORY 2255 01:33:41,000 --> 01:33:43,200 RESPONSIBILITY, MOST OF OUR 2256 01:33:43,200 --> 01:33:45,640 MISSION IS ACTUALLY WITH 2257 01:33:45,640 --> 01:33:48,920 PROTECTING AND MANAGING NATURAL 2258 01:33:48,920 --> 01:33:53,680 RESOURCES, AND SO THAT INCLUDES 2259 01:33:53,680 --> 01:33:55,600 DIFFERENT ACTIVITIES, INCLUDING 2260 01:33:55,600 --> 01:33:57,760 RESEARCH THAT'S DIRECTED FOR 2261 01:33:57,760 --> 01:34:00,200 APPLICATION TO PROTECTING AN 2262 01:34:00,200 --> 01:34:01,520 MANAGING NATURAL RESOURCES. 2263 01:34:01,520 --> 01:34:05,440 THERE IS SOME ACTIVITY WITHIN 2264 01:34:05,440 --> 01:34:09,280 DOI FOR CHEMICAL REGISTRATION OF 2265 01:34:09,280 --> 01:34:13,640 NEW PRODUCTS FOR MANAGING 2266 01:34:13,640 --> 01:34:16,240 INVASIVE SPECIES. 2267 01:34:16,240 --> 01:34:18,000 ALSO, ENVIRONMENTAL CONTAMINANT 2268 01:34:18,000 --> 01:34:20,240 BIOMONITORING EFFORTS, AS WELL 2269 01:34:20,240 --> 01:34:22,080 AS NATURAL RESOURCE DAMAGE 2270 01:34:22,080 --> 01:34:24,920 ASSESSMENT, SO ASSESSMENTS OF 2271 01:34:24,920 --> 01:34:28,000 INJURY FOR LITIGATION, AS WELL 2272 01:34:28,000 --> 01:34:32,480 AS ASSESSMENTS OF RESTORATION. 2273 01:34:32,480 --> 01:34:34,760 AND THEN ALSO ALTERNATIVES FOR 2274 01:34:34,760 --> 01:34:37,920 LEAD SHOT IS ANOTHER AREA WHERE 2275 01:34:37,920 --> 01:34:40,160 WE HAVE TOXICITY TESTING, AND 2276 01:34:40,160 --> 01:34:41,040 USE ALTERNATIVE APPROACHES. 2277 01:34:41,040 --> 01:34:43,880 AND WE DO TRY TO IMPLEMENT AND 2278 01:34:43,880 --> 01:34:45,320 EMBRACE THE THREE Rs WHEN 2279 01:34:45,320 --> 01:34:46,840 POSSIBLE, SO THIS IS MY UPDATE 2280 01:34:46,840 --> 01:34:52,840 OF WHAT THOSE ACTIVITIES ARE 2281 01:34:52,840 --> 01:34:53,400 CURRENTLY. 2282 01:34:53,400 --> 01:34:54,280 SO, PRESENTATION FOLLOWS THOSE 2283 01:34:54,280 --> 01:34:58,080 FIVE AREAS THAT I JUST OUTLINED. 2284 01:34:58,080 --> 01:35:00,720 FIRST ONE IS UPDATE ACTUALLY 2285 01:35:00,720 --> 01:35:02,880 FROM THE COLUMBIA ENVIRONMENTAL 2286 01:35:02,880 --> 01:35:04,000 RESEARCH CENTER IN CONJUNCTION 2287 01:35:04,000 --> 01:35:07,520 WITH THE WATER SCIENCE CENTER IN 2288 01:35:07,520 --> 01:35:12,880 KANSAS, WHICH IS WHERE A LOT OF 2289 01:35:12,880 --> 01:35:15,360 THE HABs WORK IS DONE WITHIN 2290 01:35:15,360 --> 01:35:22,400 USGA, ALGAL BLOOMS, CAPACITY FOR 2291 01:35:22,400 --> 01:35:28,200 CHEMICAL END OF HABs WORK, 2292 01:35:28,200 --> 01:35:29,840 CHARACTERIZING DIFFERENT TOXINS 2293 01:35:29,840 --> 01:35:33,520 PRODUCED BY AGLGAL BLOOMS, 2294 01:35:33,520 --> 01:35:35,920 THERE'S A LOT WE DON'T KNOW. 2295 01:35:35,920 --> 01:35:38,320 THERE'S NOT EVEN REALLY VERY 2296 01:35:38,320 --> 01:35:41,840 MANY STANDARDS FOR THESE TOXINS, 2297 01:35:41,840 --> 01:35:43,360 THERE'S HUNDREDS OF DIFFERENT 2298 01:35:43,360 --> 01:35:47,200 TOXICS IN THESE BLOOMS 2299 01:35:47,200 --> 01:35:47,840 POTENTIALLY. 2300 01:35:47,840 --> 01:35:52,320 SO, IN ORDER TO INTRODUCE THE 2301 01:35:52,320 --> 01:35:58,080 SO-WHAT BIOLOGY END OF THE 2302 01:35:58,080 --> 01:36:01,440 RESEARCH, IS WHERE WE COME IN, 2303 01:36:01,440 --> 01:36:02,680 CONSISTENT EFFORTS TO IMPLEMENT 2304 01:36:02,680 --> 01:36:05,840 IN SILICO APPROACHES IN ORDER TO 2305 01:36:05,840 --> 01:36:06,920 POTENTIALLY SEE WHAT PREDICTIONS 2306 01:36:06,920 --> 01:36:09,120 MIGHT BE ABLE TO BE MADE WITH 2307 01:36:09,120 --> 01:36:10,880 SOME TOXINS, WE HAVE A LOT OF 2308 01:36:10,880 --> 01:36:12,280 INFORMATION ON CHEMICAL 2309 01:36:12,280 --> 01:36:13,160 STRUCTURE AND PROPERTIES, 2310 01:36:13,160 --> 01:36:14,880 HOWEVER THERE'S NOT A LOT OF 2311 01:36:14,880 --> 01:36:15,640 TOXICITY DATA. 2312 01:36:15,640 --> 01:36:19,640 AND SO I WAS INTERESTED IN 2313 01:36:19,640 --> 01:36:21,280 NICOLE'S COMMENT ABOUT 2314 01:36:21,280 --> 01:36:23,640 INCORPORATING BIOMONITORING DATA 2315 01:36:23,640 --> 01:36:25,320 INTO THESE PREDICTION MODELS, SO 2316 01:36:25,320 --> 01:36:31,000 WE'RE DEFINITELY GOING TO BE 2317 01:36:31,000 --> 01:36:32,400 PURSUING IF THERE ARE IN SILICO 2318 01:36:32,400 --> 01:36:33,960 APPROACHES TO PRIORITIZE WHAT 2319 01:36:33,960 --> 01:36:37,880 TOXINS, YOU KNOW, MIGHT BE MOST 2320 01:36:37,880 --> 01:36:40,000 BIOACTIVE OR OF CONCERN, AND 2321 01:36:40,000 --> 01:36:42,840 ALSO WE HAVE ZEBRAFISH ASSAYS 2322 01:36:42,840 --> 01:36:46,520 ESTABLISHED THAT CAN ALSO BE 2323 01:36:46,520 --> 01:36:48,600 USED FOR PRIORITIZING AND 2324 01:36:48,600 --> 01:36:49,400 CHARACTERIZING TOXICITY OF THE 2325 01:36:49,400 --> 01:36:52,000 DIFFERENT TOXINS THAT WE DO HAVE 2326 01:36:52,000 --> 01:36:55,200 AVAILABLE, AND SO WORKING 2327 01:36:55,200 --> 01:36:58,120 CLOSELY WITH CHEMISTRY TO FILL 2328 01:36:58,120 --> 01:37:01,400 IN DATA GAPS FOR TOXICITY WITH 2329 01:37:01,400 --> 01:37:02,200 THE HABs WORK. 2330 01:37:02,200 --> 01:37:06,000 THERE ARE EFFORTS GOING ON 2331 01:37:06,000 --> 01:37:07,440 MOSTLY CONCENTRATED AT UMass, 2332 01:37:07,440 --> 01:37:10,920 WHICH IS A CENTER ON THE UPPER 2333 01:37:10,920 --> 01:37:13,560 MISSISSIPPI RIVER, THEY DEAL A 2334 01:37:13,560 --> 01:37:15,080 LOT WITH INVASIVE CARP ISSUES. 2335 01:37:15,080 --> 01:37:20,920 AND SO THERE ARE EFFORTS TO 2336 01:37:20,920 --> 01:37:22,720 PRIORITIZE COMPOUNDS FOR 2337 01:37:22,720 --> 01:37:24,840 MANAGING THESE INVASIVE SPECIES, 2338 01:37:24,840 --> 01:37:26,680 BUT WITH AS MINIMAL IMPACT AS 2339 01:37:26,680 --> 01:37:28,560 POSSIBLE ON NON-TARGET SPECIES. 2340 01:37:28,560 --> 01:37:34,360 AND SO THERE IS A LOT OF WORK IN 2341 01:37:34,360 --> 01:37:37,280 VITRO, WITH THE GILL FISH CELL 2342 01:37:37,280 --> 01:37:39,880 LINE IN ORDER TO PRIORITIZE THE 2343 01:37:39,880 --> 01:37:42,080 COMPOUNDS THAT ARE BEING 2344 01:37:42,080 --> 01:37:46,880 PROPOSED FOR REGULATION, OR FOR 2345 01:37:46,880 --> 01:37:48,440 REGULATORY ACCEPTANCE, WITH 2346 01:37:48,440 --> 01:37:51,400 THESE NAMs METHODS IN ORDER TO 2347 01:37:51,400 --> 01:37:53,360 BETTER INFORM, YOU KNOW, THOSE 2348 01:37:53,360 --> 01:37:55,680 BEST CHEMICALS TO HIT THOSE 2349 01:37:55,680 --> 01:37:58,320 TARGETS BUT WITHOUT HITTING OUR 2350 01:37:58,320 --> 01:37:58,840 NON-TARGETS PARTICULARLY 2351 01:37:58,840 --> 01:38:02,120 ENDANGERED FISH SUCH AS THE 2352 01:38:02,120 --> 01:38:02,640 PADDLEFISH. 2353 01:38:02,640 --> 01:38:07,680 AND ALSO THAT GROUP IS USING, 2354 01:38:07,680 --> 01:38:12,400 AGAIN, SOME IN SILICO, YOU KNOW, 2355 01:38:12,400 --> 01:38:15,480 METHODS AS WELL, USING SPECIES 2356 01:38:15,480 --> 01:38:18,320 SENSITIVITY DISTRIBUTION THAT 2357 01:38:18,320 --> 01:38:23,240 WAS PRESENTED BEFORE WITH THE 2358 01:38:23,240 --> 01:38:33,600 EPA PRESENTATIONS FOR 2359 01:38:39,720 --> 01:38:40,840 REGISTRATION. 2360 01:38:40,840 --> 01:38:42,600 THERE'S BIOMONITORING EFFORTS, 2361 01:38:42,600 --> 01:38:45,120 BIOLUMINESCENT YEAST ASSAYS, 2362 01:38:45,120 --> 01:38:49,320 ASTRO GENICITY OF FIELD SAMPLES, 2363 01:38:49,320 --> 01:38:50,920 WITHIN USGS THERE'S ABILITY TO 2364 01:38:50,920 --> 01:38:52,560 NOT ONLY TEST INDIVIDUAL 2365 01:38:52,560 --> 01:38:57,600 COMPOUNDS BUT ALSO WE'RE LOOKING 2366 01:38:57,600 --> 01:38:58,880 AT TESTING FIELD SAMPLES, FIELD 2367 01:38:58,880 --> 01:39:00,760 EXTRACTINGS TO GET AT REAL WORLD 2368 01:39:00,760 --> 01:39:03,160 MIXTURE QUESTION OF WHAT KIND OF 2369 01:39:03,160 --> 01:39:05,040 BIOACTIVITY IS OUT IN THESE 2370 01:39:05,040 --> 01:39:07,360 FIELDS, SAMPLES IN ORDER TO 2371 01:39:07,360 --> 01:39:11,920 PRIORITIZE AREAS OF INTEREST OR 2372 01:39:11,920 --> 01:39:14,240 CONCERN. 2373 01:39:14,240 --> 01:39:17,960 AND THEN I WANTED TO BRING AN 2374 01:39:17,960 --> 01:39:20,200 UPDATE FROM EASTERN ECOLOGICAL 2375 01:39:20,200 --> 01:39:20,880 SCIENCE CENTER. 2376 01:39:20,880 --> 01:39:22,440 THEY HAVE BEEN WORKING FOR A 2377 01:39:22,440 --> 01:39:25,480 LONG TIME IN DISEASE PREVALENCE, 2378 01:39:25,480 --> 01:39:27,680 AND BIOMONITORING FOR DISEASE 2379 01:39:27,680 --> 01:39:29,000 PREVALENCE WITH PARTICULARLY 2380 01:39:29,000 --> 01:39:31,480 BASS, LARGE AND SMALLMOUTH BASS. 2381 01:39:31,480 --> 01:39:35,880 THERE IS A LOT OF CONCERN ABOUT 2382 01:39:35,880 --> 01:39:37,520 BLOTCHY BASS SYNDROME, ANGLERS 2383 01:39:37,520 --> 01:39:38,920 GET THESE BASS AND THEY HAVE 2384 01:39:38,920 --> 01:39:40,720 THESE BLACK SPOTS ON THEM. 2385 01:39:40,720 --> 01:39:41,920 AND EVERYBODY IS LIKE, WHAT'S 2386 01:39:41,920 --> 01:39:45,360 GOING ON HERE? 2387 01:39:45,360 --> 01:39:49,160 THEY HAVE IDENTIFIED NOVEL 2388 01:39:49,160 --> 01:39:52,280 ADENOVIRUSES THAT ARE ACTUALLY 2389 01:39:52,280 --> 01:39:57,240 PRESENT IN THESE BLOTCHES, AND 2390 01:39:57,240 --> 01:40:00,840 SO USING ACTUALLY IMAGES FROM 2391 01:40:00,840 --> 01:40:03,120 ANGLERS AND CELL PHONE 2392 01:40:03,120 --> 01:40:06,280 TECHNOLOGY WE CAN INCREASE THE 2393 01:40:06,280 --> 01:40:09,280 OCCURRENCE DATA FOR WHERE 2394 01:40:09,280 --> 01:40:11,240 THESE -- WHERE THE BLOTCHY BASS 2395 01:40:11,240 --> 01:40:12,440 SYNDROME IS OCCURRING BUT 2396 01:40:12,440 --> 01:40:15,080 WITHOUT SO MUCH HEAVY ACTUAL 2397 01:40:15,080 --> 01:40:16,360 SAMPLING OF THOSE FISH. 2398 01:40:16,360 --> 01:40:20,840 SO NO NEED TO ACTUALLY, YOU 2399 01:40:20,840 --> 01:40:22,320 KNOW, SACRIFICE THESE ORGANISMS 2400 01:40:22,320 --> 01:40:24,880 BUT HAVING ANGLERS THAT ARE 2401 01:40:24,880 --> 01:40:26,320 ALREADY OUT DOING THOSE 2402 01:40:26,320 --> 01:40:27,720 ACTIVITIES TAKING RECORD OF 2403 01:40:27,720 --> 01:40:30,040 THOSE AND INCORPORATING THAT 2404 01:40:30,040 --> 01:40:33,560 INTO OUR CURRENT DATA FOR 2405 01:40:33,560 --> 01:40:34,440 BLOTCHY BASS SYNDROME. 2406 01:40:34,440 --> 01:40:37,280 AND ALSO YOU CAN SEE HERE, IF IT 2407 01:40:37,280 --> 01:40:39,640 WILL PLAY, THERE'S A VIDEO 2408 01:40:39,640 --> 01:40:40,920 SHOWING YOU THAT ACTUALLY THIS 2409 01:40:40,920 --> 01:40:42,920 SWAB METHOD, YOU CAN SEE 2410 01:40:42,920 --> 01:40:45,440 COLORATION THAT ACTUALLY IS ON 2411 01:40:45,440 --> 01:40:50,560 THE SWAB FROM THIS SAMPLING. 2412 01:40:50,560 --> 01:40:51,640 AND STATE FISHERIES, MANAGERS, 2413 01:40:51,640 --> 01:40:53,200 HAVE ACTUALLY BEEN TRAINED TO 2414 01:40:53,200 --> 01:40:55,960 USE THIS APPROACH TO SAMPLE 2415 01:40:55,960 --> 01:40:57,680 AGAIN NON-INVASIVELY, NOT 2416 01:40:57,680 --> 01:40:59,800 HARMING THE ORGANISM, IN ORDER 2417 01:40:59,800 --> 01:41:03,040 TO TRACK THESE DIFFERENT 2418 01:41:03,040 --> 01:41:03,280 VIRUSES. 2419 01:41:03,280 --> 01:41:05,040 AND SO I WANTED TO GIVE THAT AS 2420 01:41:05,040 --> 01:41:06,760 PART OF THE UPDATE BECAUSE IT IS 2421 01:41:06,760 --> 01:41:09,320 RELEVANT TO THE THREE Rs 2422 01:41:09,320 --> 01:41:10,800 APPLICATION BECAUSE, YOU KNOW, 2423 01:41:10,800 --> 01:41:12,120 INSTEAD OF SACRIFICING MORE 2424 01:41:12,120 --> 01:41:15,320 ANIMALS OR CAUSING MORE HARM TO 2425 01:41:15,320 --> 01:41:16,840 ANIMALS WE'RE ACTUALLY MAKING AN 2426 01:41:16,840 --> 01:41:21,560 ATTEMPT TO REDUCE THAT BY DOING 2427 01:41:21,560 --> 01:41:23,640 NON-INVASIVE SAMPLING METHODS OR 2428 01:41:23,640 --> 01:41:24,760 MINIMALLY INVASIVE, DEFINITELY 2429 01:41:24,760 --> 01:41:28,360 NON-LETHAL. 2430 01:41:28,360 --> 01:41:30,520 COUPLE OTHER APPROACHES IN THE 2431 01:41:30,520 --> 01:41:36,240 WORK A GILL SAMPLING METHOD, 2432 01:41:36,240 --> 01:41:38,080 NON-LETHAL TO TRACK DIFFERENT 2433 01:41:38,080 --> 01:41:42,280 PATHOGENS IN THE FISH. 2434 01:41:42,280 --> 01:41:44,320 AND THEN ACTUALLY AT SERT USING 2435 01:41:44,320 --> 01:41:48,160 A.I. MODEL TO TRAIN TO 2436 01:41:48,160 --> 01:41:49,360 AUTOMATICALLY IDENTIFY AND COUNT 2437 01:41:49,360 --> 01:41:50,560 DIFFERENT WHITE BLOOD CELL TYPES 2438 01:41:50,560 --> 01:41:54,080 THAT YOU CAN SEE AN EXAMPLE OF 2439 01:41:54,080 --> 01:41:57,000 HERE IN THIS IMAGE, IN ORDER TO 2440 01:41:57,000 --> 01:41:58,480 INCREASE THE THROUGHPUT FOR 2441 01:41:58,480 --> 01:42:01,320 ANALYSIS AND REDUCE NEED FOR 2442 01:42:01,320 --> 01:42:03,400 EXPERTISE FOR THAT ONE ENDPOINT 2443 01:42:03,400 --> 01:42:05,880 IN A FISH HEALTH ASSESSMENT SO, 2444 01:42:05,880 --> 01:42:08,440 AGAIN, GETTING, YOU KNOW, IMMUNE 2445 01:42:08,440 --> 01:42:10,840 RESPONSE OR FISH HEALTH DATA, A 2446 01:42:10,840 --> 01:42:12,440 LOT QUICKER AND BLOOD SAMPLES 2447 01:42:12,440 --> 01:42:17,280 CAN BE TAKEN NON-LETHALLY, 2448 01:42:17,280 --> 01:42:19,360 INCREASING EFFORTS TO GET MORE 2449 01:42:19,360 --> 01:42:22,000 INFORMATION OVER A WIDER 2450 01:42:22,000 --> 01:42:24,160 GEOLOGICAL SCALE BUT WITH MORE 2451 01:42:24,160 --> 01:42:26,360 MINIMAL SAMPLING EFFORTS AND 2452 01:42:26,360 --> 01:42:28,960 PARTICULARLY WITH SACRIFICING OR 2453 01:42:28,960 --> 01:42:31,160 HARMING THE ORGANISMS. 2454 01:42:31,160 --> 01:42:32,720 ALSO ALONG THOSE LINES, AND I 2455 01:42:32,720 --> 01:42:34,040 KNOW I PRESENTED THIS BEFORE, 2456 01:42:34,040 --> 01:42:37,240 BUT JUST WANTED TO GIVE AN 2457 01:42:37,240 --> 01:42:40,840 UPDATE THAT USGS IN PARTICULAR 2458 01:42:40,840 --> 01:42:45,920 HAS VERY ACTIVE PROGRAMS USING E 2459 01:42:45,920 --> 01:42:47,360 DNA, ENVIRONMENTAL DNA, CELLS 2460 01:42:47,360 --> 01:42:49,000 THAT SLOUGHED OFF FROM ORGANISMS 2461 01:42:49,000 --> 01:42:56,680 THAT CAN THEN BE SAMPLED WITH 2462 01:42:56,680 --> 01:43:00,280 PARTICULAR WATER SAMPLING 2463 01:43:00,280 --> 01:43:01,920 TECHNIQUES, AGENCIES HAVE BEEN 2464 01:43:01,920 --> 01:43:04,120 TRAINED, FOR A VARIETY OF 2465 01:43:04,120 --> 01:43:06,320 APPLICATIONS SO SPECIES 2466 01:43:06,320 --> 01:43:08,040 MONITORING AND SURVEYING AGAIN 2467 01:43:08,040 --> 01:43:09,160 YOU'RE GREATLY REDUCING THE 2468 01:43:09,160 --> 01:43:10,720 IMPACT THAT YOU'RE HAVING ON THE 2469 01:43:10,720 --> 01:43:14,960 HABITAT SO A LOT LESS 2470 01:43:14,960 --> 01:43:16,360 DESTRUCTIVE HABITAT, OR LESS 2471 01:43:16,360 --> 01:43:20,520 DESTRUCTIVE ON THE HABITAT OF 2472 01:43:20,520 --> 01:43:26,080 THE ORGANISMS, FOR INSTANCE 2473 01:43:26,080 --> 01:43:28,520 MUSSELS, OR HELL BENDERS, THINGS 2474 01:43:28,520 --> 01:43:29,800 LIKE THAT, SO REDUCES THAT 2475 01:43:29,800 --> 01:43:35,840 IMPACT ON THE HABITAT WITH THE 2476 01:43:35,840 --> 01:43:37,920 SAMPLING USING e-DNA INSTEAD, 2477 01:43:37,920 --> 01:43:39,080 AND DIFFERENT ECOLOGICAL 2478 01:43:39,080 --> 01:43:41,600 QUESTIONS, ALSO GETTING BACK TO 2479 01:43:41,600 --> 01:43:45,360 TOXICOLOGY SIDE CAN ALSO USE IT 2480 01:43:45,360 --> 01:43:47,240 IN COORDINATION WITH CHEMICAL 2481 01:43:47,240 --> 01:43:48,840 SAMPLING, LOOKING AT 2482 01:43:48,840 --> 01:43:52,400 CONCENTRATIONS OF CONTAMINANTS, 2483 01:43:52,400 --> 01:43:53,680 AND USING META BARCODING 2484 01:43:53,680 --> 01:43:57,520 APPROACHES TO LOOK AT SHIFTS IN 2485 01:43:57,520 --> 01:44:01,560 THE ECOLOGICAL STRUCTURE IN THAT 2486 01:44:01,560 --> 01:44:02,600 PARTICULAR ENVIRONMENT. 2487 01:44:02,600 --> 01:44:05,920 AS I MENTIONED BEFORE WE ALSO 2488 01:44:05,920 --> 01:44:09,760 HAVE ONGOING EFFORT FOR 2489 01:44:09,760 --> 01:44:11,960 REPLACEMENT OF LEAD SHOT. 2490 01:44:11,960 --> 01:44:14,920 I BELIEVE IT'S LIKE 13 DIFFERENT 2491 01:44:14,920 --> 01:44:16,200 LEAD SHOT ALTERNATIVES APPROVED 2492 01:44:16,200 --> 01:44:19,200 OVER THE LAST 25 YEARS, USING NO 2493 01:44:19,200 --> 01:44:21,520 TOXICITY TESTING BECAUSE WE HAVE 2494 01:44:21,520 --> 01:44:22,480 THIS ALTERNATIVE APPROACH SET 2495 01:44:22,480 --> 01:44:24,680 UP, IN ORDER TO USE EXISTING 2496 01:44:24,680 --> 01:44:26,240 INFORMATION TO DO A RISK 2497 01:44:26,240 --> 01:44:27,880 ASSESSMENT AND GO THROUGH THAT 2498 01:44:27,880 --> 01:44:29,840 APPROVAL PROCESS. 2499 01:44:29,840 --> 01:44:32,040 AND THEN I ALSO WANTED TO ADD 2500 01:44:32,040 --> 01:44:34,720 THIS, AT THE END, A LITTLE BIT 2501 01:44:34,720 --> 01:44:40,320 OF AN UPDATE ON DOI AND OUR 2502 01:44:40,320 --> 01:44:41,440 APPROACH FOR INCORPORATING 2503 01:44:41,440 --> 01:44:44,600 METRICS, YOU KNOW, OF HOW WE'RE 2504 01:44:44,600 --> 01:44:46,160 IMPLEMENTING THE THREE Rs 2505 01:44:46,160 --> 01:44:48,240 REDUCING ANIMAL USE, WE REALLY 2506 01:44:48,240 --> 01:44:50,400 WANT TO, AS I SAID, CONTINUE TO 2507 01:44:50,400 --> 01:44:53,000 REDUCE ANIMAL USE AND IMPACT ON 2508 01:44:53,000 --> 01:44:55,560 THE ORGANISMS FOR OUR 2509 01:44:55,560 --> 01:44:56,840 ECOTOXICOLOGY RESEARCH, AND 2510 01:44:56,840 --> 01:44:57,960 TESTING BUT WITHOUT COMPROMISING 2511 01:44:57,960 --> 01:45:00,680 THE DATA THAT WE NEED FOR 2512 01:45:00,680 --> 01:45:02,360 DECISION MAKING. 2513 01:45:02,360 --> 01:45:03,240 WE REALLY DECIDED -- DISCOVERED 2514 01:45:03,240 --> 01:45:06,080 THAT FIRST OF ALL WE NEEDED TO 2515 01:45:06,080 --> 01:45:08,200 DEFINE TOXICITY TESTING IN DOI 2516 01:45:08,200 --> 01:45:09,680 BECAUSE WE HAVE A LOT OF 2517 01:45:09,680 --> 01:45:12,520 ACTIVITIES THAT DON'T FALL UNDER 2518 01:45:12,520 --> 01:45:13,920 TRADITIONAL ACTIVITIES LIKE 2519 01:45:13,920 --> 01:45:16,000 REGULATORY TOXICITY TESTING, FOR 2520 01:45:16,000 --> 01:45:21,160 EXAMPLE, AND SO WE HAVE INCLUDED 2521 01:45:21,160 --> 01:45:22,400 PRODUCT APPROVAL, ECOTOXICOLOGY 2522 01:45:22,400 --> 01:45:24,200 LABORATORY AND FIELD RESEARCH AS 2523 01:45:24,200 --> 01:45:26,960 WELL AS BIOMONITORING AND DAMAGE 2524 01:45:26,960 --> 01:45:27,840 ASSESSMENT THAT INJURY 2525 01:45:27,840 --> 01:45:33,960 ASSESSMENT IN WHAT WE DEFINE AS 2526 01:45:33,960 --> 01:45:36,080 TOXICITY TESTING. 2527 01:45:36,080 --> 01:45:39,880 WE SURVEYED DOI, SCIENTISTS IN 2528 01:45:39,880 --> 01:45:42,320 DOI ANOTHER IMMEDIATE HURDLE 2529 01:45:42,320 --> 01:45:42,920 COORDINATING COMMUNICATION 2530 01:45:42,920 --> 01:45:44,720 WITHIN DOI WHO IS DOING ANIMAL 2531 01:45:44,720 --> 01:45:47,880 TESTING, WHO IS DOING TOX 2532 01:45:47,880 --> 01:45:49,840 TESTING, AND USING ANIMALS AND 2533 01:45:49,840 --> 01:45:52,240 WHAT DO YOU KNOW ABOUT NAMs, 2534 01:45:52,240 --> 01:45:54,000 HOW ARE YOU IMPLEMENTING THEM, 2535 01:45:54,000 --> 01:45:55,200 ARE YOU IMPLEMENTING THEM, DO 2536 01:45:55,200 --> 01:45:56,120 YOU HAVE THE INFORMATION AND 2537 01:45:56,120 --> 01:46:01,320 RESOURCES YOU NEED TO DO SO? 2538 01:46:01,320 --> 01:46:02,280 WE'VE DONE INITIAL SURVEYS, 2539 01:46:02,280 --> 01:46:05,960 OFFERED A TRAINING COURSE 2540 01:46:05,960 --> 01:46:07,120 THROUGH AWIC, THEY WERE GRACIOUS 2541 01:46:07,120 --> 01:46:12,280 TO HELP US DEVELOPING A TRAINING 2542 01:46:12,280 --> 01:46:15,000 COURSE FOR DOI FOCUSED ON 2543 01:46:15,000 --> 01:46:16,320 ECO-TOX TESTING AN 2544 01:46:16,320 --> 01:46:19,280 IMPLEMENTATION OF NAMs AS 2545 01:46:19,280 --> 01:46:21,040 OPPOSED TO MORE BROAD AWIC 2546 01:46:21,040 --> 01:46:22,560 TRAINING THAT MEANS OUR TRAINING 2547 01:46:22,560 --> 01:46:24,320 REQUIREMENTS SO WE'RE TRACKING 2548 01:46:24,320 --> 01:46:25,840 FOLKS THAT HAVE TAKEN THAT 2549 01:46:25,840 --> 01:46:27,800 TRAINING THAT INCLUDES MORE 2550 01:46:27,800 --> 01:46:29,160 INFORMATION WITH NAMs. 2551 01:46:29,160 --> 01:46:31,200 AND THEN WE'RE ALSO IN THE 2552 01:46:31,200 --> 01:46:32,960 PROCESS OF UPDATING TRACKING OF 2553 01:46:32,960 --> 01:46:34,400 WHICH STUDIES, SO STUDY PLANS 2554 01:46:34,400 --> 01:46:37,640 THAT COME IN THAT ARE USING 2555 01:46:37,640 --> 01:46:39,520 THESE NAMs, IN THEIR 2556 01:46:39,520 --> 01:46:41,280 APPROACHES, AND REDUCING THEIR 2557 01:46:41,280 --> 01:46:44,000 ANIMAL USE THAT WAY, ALSO AS I 2558 01:46:44,000 --> 01:46:44,880 SAID COORDINATING ALL THESE 2559 01:46:44,880 --> 01:46:46,880 THINGS HAS BEEN A CHALLENGE, AND 2560 01:46:46,880 --> 01:46:50,480 SO WE'RE ALSO IN THE PROCESS OF 2561 01:46:50,480 --> 01:46:52,200 ATTEMPTING TO FORMULATE A 2562 01:46:52,200 --> 01:46:55,280 WEBSITE THAT CAN BE USED BY DOI 2563 01:46:55,280 --> 01:46:58,360 SCIENTISTS AS WELL AS 2564 01:46:58,360 --> 01:46:59,520 PUBLIC-FACING WEBSITE THAT WOULD 2565 01:46:59,520 --> 01:47:02,800 ALLOW THE PUBLIC TO SEE WHAT 2566 01:47:02,800 --> 01:47:04,480 ACTIVITIES DOI SPECIFICALLY IS 2567 01:47:04,480 --> 01:47:06,680 DOING IN THESE EFFORTS. 2568 01:47:06,680 --> 01:47:09,000 BUT ALSO PROVIDING INFORMATION 2569 01:47:09,000 --> 01:47:11,720 FOR DOI SCIENTISTS IN A 2570 01:47:11,720 --> 01:47:12,240 CONCENTRATED AREA THAT'S 2571 01:47:12,240 --> 01:47:13,480 SPECIFIC TO THE WORK THEY DO 2572 01:47:13,480 --> 01:47:15,880 THAT WOULD GIVE THEM MORE 2573 01:47:15,880 --> 01:47:18,520 INFORMATION ON THE NAMs 2574 01:47:18,520 --> 01:47:20,280 APPROACHES THAT ARE AVAILABLE. 2575 01:47:20,280 --> 01:47:21,360 THAT'S ALL I HAVE. 2576 01:47:21,360 --> 01:47:22,800 THANK YOU. 2577 01:47:22,800 --> 01:47:25,520 [APPLAUSE] 2578 01:47:25,520 --> 01:47:31,560 2579 01:47:31,560 --> 01:47:31,680 2580 01:47:31,680 --> 01:47:33,080 >> THANK YOU. 2581 01:47:33,080 --> 01:47:34,520 WE HAVE TIME FOR QUESTIONS. 2582 01:47:34,520 --> 01:47:35,960 WE'LL START WITH THE ROOM IF 2583 01:47:35,960 --> 01:47:37,000 THERE'S ANY QUESTIONS FOR 2584 01:47:37,000 --> 01:47:38,440 JESSICA IN THE ROOM, AND THEN 2585 01:47:38,440 --> 01:47:40,200 FOLLOWING THAT WE'LL GO TO SOME 2586 01:47:40,200 --> 01:47:41,040 ADDITIONAL QUESTIONS THAT HAVE 2587 01:47:41,040 --> 01:47:43,600 COME IN ONLINE IN THE INTERIM 2588 01:47:43,600 --> 01:47:44,240 TIME. 2589 01:47:44,240 --> 01:47:47,640 FIRST ANY QUESTIONS FOR JESSICA? 2590 01:47:47,640 --> 01:47:55,680 2591 01:47:55,680 --> 01:47:56,400 2592 01:47:56,400 --> 01:47:58,080 >> YEAH, HI. 2593 01:47:58,080 --> 01:47:59,040 ALISON HARRILL, EPA. 2594 01:47:59,040 --> 01:48:00,720 I HAD A QUESTION ABOUT SOME IN 2595 01:48:00,720 --> 01:48:02,800 VITRO STUDIES THAT YOU'RE DOING 2596 01:48:02,800 --> 01:48:04,000 WITH GILL CELLS. 2597 01:48:04,000 --> 01:48:05,960 YOU SHOWED YOU'RE DOING SOME 2598 01:48:05,960 --> 01:48:06,600 HIGH-THROUGHPUT ASSAYS BUT I 2599 01:48:06,600 --> 01:48:08,720 DIDN'T SEE A LOT OF DETAIL ON 2600 01:48:08,720 --> 01:48:09,920 WHAT PHENOTYPES YOU'RE LOOKING 2601 01:48:09,920 --> 01:48:11,640 FOR, WONDERING IF YOU CAN GIVE 2602 01:48:11,640 --> 01:48:13,640 MORE CONTEXT AROUND THE STUDIES 2603 01:48:13,640 --> 01:48:14,440 THAT YOU'RE DOING. 2604 01:48:14,440 --> 01:48:18,560 >> I'M ACTUALLY NOT DOING THOSE 2605 01:48:18,560 --> 01:48:18,800 STUDIES. 2606 01:48:18,800 --> 01:48:21,080 I'M PERSONALLY NOT DOING THOSE 2607 01:48:21,080 --> 01:48:22,040 STUDIES BUT CAN GET YOU IN 2608 01:48:22,040 --> 01:48:23,600 CONTACT WITH THE GROUP AT 2609 01:48:23,600 --> 01:48:25,360 UMass THAT IS DOING THAT 2610 01:48:25,360 --> 01:48:27,520 RESEARCH AND THEY COULD GIVE YOU 2611 01:48:27,520 --> 01:48:28,320 MORE INFORMATION FOR SURE 2612 01:48:28,320 --> 01:48:29,720 >>I'D BE REALLY INTERESTED IN 2613 01:48:29,720 --> 01:48:31,120 THAT BECAUSE WE'RE STARTING TO 2614 01:48:31,120 --> 01:48:32,720 DO SIMILAR WORK AT EPA. 2615 01:48:32,720 --> 01:48:33,760 >> OKAY, YEAH. 2616 01:48:33,760 --> 01:48:35,840 YEP, I CAN GET THAT YOU CONTACT 2617 01:48:35,840 --> 01:48:38,280 INFORMATION SO YOU GUYS CAN 2618 01:48:38,280 --> 01:48:38,560 COORDINATE. 2619 01:48:38,560 --> 01:48:39,520 >> AWESOME, THANK YOU. 2620 01:48:39,520 --> 01:48:46,880 >> YEAH. 2621 01:48:46,880 --> 01:48:52,040 >> I THINK WE HAD A COUPLE 2622 01:48:52,040 --> 01:48:55,680 QUESTIONS ONLINE FOR PREVIOUS 2623 01:48:55,680 --> 01:48:55,960 PRESENTERS. 2624 01:48:55,960 --> 01:49:02,360 >> JUST ONE FOR ANNA LOWIT. 2625 01:49:02,360 --> 01:49:04,120 TIFFANY STATES I'D LIKE TO LEARN 2626 01:49:04,120 --> 01:49:06,320 WHERE OPPT IS HEADED WITH THE 2627 01:49:06,320 --> 01:49:09,920 STAKEHOLDER ACCEPTANCE OF THE 2628 01:49:09,920 --> 01:49:12,560 EYE IRRITATION AND RESPIRATORY 2629 01:49:12,560 --> 01:49:15,200 SENSITIZATION NON-ANIMAL 2630 01:49:15,200 --> 01:49:16,600 METHODS. 2631 01:49:16,600 --> 01:49:18,640 >> YEAH, THANKS FOR THE 2632 01:49:18,640 --> 01:49:20,320 QUESTION, TIFFANY. 2633 01:49:20,320 --> 01:49:24,920 SO WE DID PRESENT AT THE SOT 2634 01:49:24,920 --> 01:49:28,440 ONGOING WORK WE HAVE WITH OUR 2635 01:49:28,440 --> 01:49:29,480 EXTERNAL COLLABORATORS ON EYE 2636 01:49:29,480 --> 01:49:33,880 IRRITATION SO THAT WAS IN MY 2637 01:49:33,880 --> 01:49:34,600 PRESENTATION, AND THAT POSTER 2638 01:49:34,600 --> 01:49:38,040 CAN BE FOUND ON THE SOT WEBSITE 2639 01:49:38,040 --> 01:49:41,400 STILL, OR I CAN SEND IT TO THOSE 2640 01:49:41,400 --> 01:49:41,760 INTERESTED. 2641 01:49:41,760 --> 01:49:43,320 WE'RE ACTIVELY WORKING 2642 01:49:43,320 --> 01:49:45,360 INTERNALLY ON SIMILAR FRAMEWORKS 2643 01:49:45,360 --> 01:49:48,760 FOR SKIN IRRITATION, AND ARE 2644 01:49:48,760 --> 01:49:51,280 JUST STARTING TO THINK ABOUT 2645 01:49:51,280 --> 01:49:52,320 SKIN SENSITIZATION SPACE AND HOW 2646 01:49:52,320 --> 01:49:55,640 TO BRING IN THE NEW DEFINED 2647 01:49:55,640 --> 01:49:57,960 APPROACH, AND MAKE THE MOST OF 2648 01:49:57,960 --> 01:50:02,440 THE ONGOING EFFORTS AT OECD IN 2649 01:50:02,440 --> 01:50:04,480 THE SERA MODEL. 2650 01:50:04,480 --> 01:50:05,360 THIS RESPIRATORY SENSITIZATION 2651 01:50:05,360 --> 01:50:08,320 WORK IS IN MY MIND FROM A 2652 01:50:08,320 --> 01:50:11,160 REGULATORY POINT OF VIEW 2653 01:50:11,160 --> 01:50:13,920 MULTIPLE YEARS AWAY FROM USE. 2654 01:50:13,920 --> 01:50:16,960 THERE ARE A COUPLE GROUPS 2655 01:50:16,960 --> 01:50:21,440 WORKING ON THESE ASSAYS AND THE 2656 01:50:21,440 --> 01:50:22,800 OECD IS GOING TO DEVELOP A STATE 2657 01:50:22,800 --> 01:50:24,200 OF THE SCIENCE PAPER ON WHERE 2658 01:50:24,200 --> 01:50:26,600 THEY ARE AND WHAT ADDITIONAL 2659 01:50:26,600 --> 01:50:28,560 WORK MAY OR MAY NOT NEED TO BE 2660 01:50:28,560 --> 01:50:30,640 DONE IN TERMS OF CONFIDENCE 2661 01:50:30,640 --> 01:50:31,640 BUILDING AND THERE ARE PROBABLY 2662 01:50:31,640 --> 01:50:33,920 PEOPLE IN THIS ROOM WHO KNOW THE 2663 01:50:33,920 --> 01:50:36,680 STATUS BETTER THAN I DO. 2664 01:50:36,680 --> 01:50:41,920 THERE'S REASON TO BE OPTIMISTIC 2665 01:50:41,920 --> 01:50:43,880 BUT I THINK WE'RE SEVERAL YEARS 2666 01:50:43,880 --> 01:50:46,720 AWAY FROM HAVING A TOOL THAT WE 2667 01:50:46,720 --> 01:50:47,280 CAN USE. 2668 01:50:47,280 --> 01:50:49,440 >> OKAY. 2669 01:50:49,440 --> 01:50:50,440 ANY ADDITIONAL QUESTIONS FROM 2670 01:50:50,440 --> 01:50:52,160 ONLINE YET? 2671 01:50:52,160 --> 01:50:52,960 NOPE? 2672 01:50:52,960 --> 01:50:53,360 OKAY. 2673 01:50:53,360 --> 01:50:57,160 SO WE ARE ACTUALLY BREAKING FOR 2674 01:50:57,160 --> 01:50:59,640 TWO HOURS FOR LUNCH. 2675 01:50:59,640 --> 01:51:00,400 PARTIALLY BECAUSE THE NATCHER 2676 01:51:00,400 --> 01:51:03,680 CENTER AT NIH HAS NOT REOPENED 2677 01:51:03,680 --> 01:51:05,240 THEIR CAFETERIA YET POST-COVID 2678 01:51:05,240 --> 01:51:06,480 FOR OUR IN-PERSON ATTENDEES WE 2679 01:51:06,480 --> 01:51:08,200 HAVE A SHUTTLE TO TAKE YOU TO A 2680 01:51:08,200 --> 01:51:10,480 CAFETERIA ON THE OTHER SIDE OF 2681 01:51:10,480 --> 01:51:11,680 THE NIH CAMPUS. 2682 01:51:11,680 --> 01:51:14,680 FOR THOSE ONLINE, YOU GET A NICE 2683 01:51:14,680 --> 01:51:16,120 TWO-HOUR BREAK TO CATCH UP ON 2684 01:51:16,120 --> 01:51:18,560 E-MAILS AND COME BACK AND JOIN 2685 01:51:18,560 --> 01:51:21,000 US AT 1:20 P.M. 2686 01:51:21,000 --> 01:51:22,760 WE WILL BE KICKING OFF IN THE 2687 01:51:22,760 --> 01:51:28,440 AFTERNOON WITH AN EXCITING 2688 01:51:28,440 --> 01:51:33,800 UPDATE FROM CHARLES KOVATCH, 2689 01:51:33,800 --> 01:51:35,120 OECD COORDINATOR, WITH GREAT 2690 01:51:35,120 --> 01:51:36,120 CONTENT IN PRESENTATIONS AFTER 2691 01:51:36,120 --> 01:51:36,440 LUNCH. 2692 01:51:36,440 --> 01:51:38,440 FOR THOSE WHO ARE WATCHING THE 2693 01:51:38,440 --> 01:51:40,360 WEBCAST, PLEASE FEEL FREE TO 2694 01:51:40,360 --> 01:51:44,760 SEND YOUR QUESTIONS TO THE 2695 01:51:44,760 --> 01:51:45,960 ICCVAM QUESTIONS NIEHS E-MAIL 2696 01:51:45,960 --> 01:51:48,080 ADDRESS AND WE'LL ADDRESS THOSE 2697 01:51:48,080 --> 01:51:49,720 AFTER LUNCH DURING ONE OF THE 2698 01:51:49,720 --> 01:51:51,080 DISCUSSION SECTIONS. 2699 01:51:51,080 --> 01:51:52,880 FOR NOW WE'LL BREAK FOR TWO 2700 01:51:52,880 --> 01:51:55,640 HOURS, SEE YOU BACK AT 1:20 P.M. 2701 01:51:55,640 --> 01:51:58,240 THANKS. 2702 01:51:58,240 --> 01:52:02,480 WE ARE NOW GOING TO START WITH OUR 2703 01:52:02,480 --> 01:52:03,280 AFTERNOON SESSION. 2704 01:52:03,280 --> 01:52:09,600 SO, FIRST CAN I JUST DOUBLE 2705 01:52:09,600 --> 01:52:13,120 CHECK, CHARLES, THAT -- GO ON. 2706 01:52:13,120 --> 01:52:15,120 FIRST, WELL, I NEEDED THOSE. 2707 01:52:15,120 --> 01:52:16,400 THANKS, DAVE. 2708 01:52:16,400 --> 01:52:18,360 IT'S OKAY, I'LL DO IT. 2709 01:52:18,360 --> 01:52:19,960 CAN I FIRST DOUBLE CHECK, 2710 01:52:19,960 --> 01:52:22,000 CHARLES, THAT YOU'RE ONLINE AND 2711 01:52:22,000 --> 01:52:24,840 WE CAN HEAR YOU? 2712 01:52:24,840 --> 01:52:26,400 2713 01:52:26,400 --> 01:52:27,440 >> YES, I'M ONLINE. 2714 01:52:27,440 --> 01:52:28,240 CAN YOU HEAR ME? 2715 01:52:28,240 --> 01:52:28,800 >>I CAN. 2716 01:52:28,800 --> 01:52:30,840 YOU COME IN LOUD AND CLEAR. 2717 01:52:30,840 --> 01:52:31,920 THANK YOU SO MUCH. 2718 01:52:31,920 --> 01:52:33,000 >> PERFECT. 2719 01:52:33,000 --> 01:52:34,120 >> OKAY. 2720 01:52:34,120 --> 01:52:36,360 SO, ARE YOU SEEING YOUR SLIDES 2721 01:52:36,360 --> 01:52:41,560 AS THEY SHOULD BE PROJECTED? 2722 01:52:41,560 --> 01:52:43,120 >> NO, I DON'T. 2723 01:52:43,120 --> 01:52:43,440 >>OKAY. 2724 01:52:43,440 --> 01:52:46,200 >> YES, I DO. 2725 01:52:46,200 --> 01:52:49,040 WELL, ALMOST. 2726 01:52:49,040 --> 01:52:50,160 >> HOW ABOUT NOW? 2727 01:52:50,160 --> 01:52:55,800 IT'S ON THE FIRST SLIDE? 2728 01:52:55,800 --> 01:52:57,880 >> I SEE THE SLIDES. 2729 01:52:57,880 --> 01:52:59,800 IT'S NOT ON MY MAIN COMPUTER, 2730 01:52:59,800 --> 01:53:01,280 IT'S WEIRD, LIKE ON THE 2731 01:53:01,280 --> 01:53:02,400 SUBWINDOW, BUT AS LONG AS 2732 01:53:02,400 --> 01:53:04,040 EVERYBODY ELSE CAN SEE THEM, 2733 01:53:04,040 --> 01:53:04,440 WE'RE FINE. 2734 01:53:04,440 --> 01:53:05,760 >>WE'RE GETTING THE FEEDBACK 2735 01:53:05,760 --> 01:53:08,160 THAT IT IS BEING PROJECTED ON 2736 01:53:08,160 --> 01:53:10,040 THE WEBCAST APPROPRIATELY SO 2737 01:53:10,040 --> 01:53:11,200 IT'S OKAY. 2738 01:53:11,200 --> 01:53:13,520 SO, IF YOU WANT TO JUST GO AHEAD 2739 01:53:13,520 --> 01:53:14,720 AND TELL ME WHEN YOU'D LIKE ME 2740 01:53:14,720 --> 01:53:17,720 TO GO TO THE NEXT SLIDE I'D BE 2741 01:53:17,720 --> 01:53:23,720 HAPPY TO DO THAT FOR YOU. 2742 01:53:23,720 --> 01:53:29,040 ALL 2743 01:53:29,040 --> 01:53:29,240 RIGHT. 2744 01:53:29,240 --> 01:53:30,720 >> ALL RIGHT. 2745 01:53:30,720 --> 01:53:33,040 YOU CAN STILL HEAR ME? 2746 01:53:33,040 --> 01:53:34,120 >>YOU SOUND GREAT. 2747 01:53:34,120 --> 01:53:35,760 >> ALL RIGHT. 2748 01:53:35,760 --> 01:53:39,480 WELL, HI, FOLKS. 2749 01:53:39,480 --> 01:53:41,320 CHARLES KOVATCH, NATIONAL 2750 01:53:41,320 --> 01:53:43,400 COORDINATOR TO THE OCWNT, ALSO 2751 01:53:43,400 --> 01:53:45,480 EPA OFFICE OF CHEMICAL SAFETY, 2752 01:53:45,480 --> 01:53:46,040 POLLUTION PREVENTION. 2753 01:53:46,040 --> 01:53:50,520 I WISH I COULD BE WITH YOU THERE 2754 01:53:50,520 --> 01:53:50,720 TODAY. 2755 01:53:50,720 --> 01:53:53,600 HOWEVER, WE HAVE A BUG OF THE 2756 01:53:53,600 --> 01:53:58,520 BIOLOGICAL KIND KEEPING US AT 2757 01:53:58,520 --> 01:53:58,680 BAY. 2758 01:53:58,680 --> 01:54:02,240 NEXT SLIDE. 2759 01:54:02,240 --> 01:54:02,600 GREAT. 2760 01:54:02,600 --> 01:54:04,640 I ALWAYS THINK IT'S GOOD TO 2761 01:54:04,640 --> 01:54:08,800 START WITH AN OVERVIEW, REMINDER 2762 01:54:08,800 --> 01:54:12,640 OF OF OECD STANDS FOR. 2763 01:54:12,640 --> 01:54:14,800 IT'S A COLLABORATIVE BODY THAT 2764 01:54:14,800 --> 01:54:19,960 WORKS ON A NUMBER OF ISSUES. 2765 01:54:19,960 --> 01:54:24,000 IT'S BEEN AROUND SINCE THE 2766 01:54:24,000 --> 01:54:25,320 '50s, SO EPA -- THE UNITED 2767 01:54:25,320 --> 01:54:31,160 STATES IS A MEMBER COUNTRY TO 2768 01:54:31,160 --> 01:54:33,560 THE OECD, SPECIFICALLY LOOKING 2769 01:54:33,560 --> 01:54:34,840 AT CHEMICALS, BIOTECHNOLOGY 2770 01:54:34,840 --> 01:54:35,240 COMMITTEE. 2771 01:54:35,240 --> 01:54:39,360 WE'RE ONE OF THE MEMBER 2772 01:54:39,360 --> 01:54:43,960 COUNTRIES WORKING UNDER THE CDC, 2773 01:54:43,960 --> 01:54:47,880 A NUMBER OF TOPICS, WE'RE 2774 01:54:47,880 --> 01:54:49,040 SPECIFICALLY SUPPORTING THE 2775 01:54:49,040 --> 01:54:50,960 MUTUAL ACCEPTANCE OF DATA. 2776 01:54:50,960 --> 01:54:53,160 TWO PILLARS ARE TEST GUIDELINES 2777 01:54:53,160 --> 01:54:56,200 AND GOOD LABORATORY PRACTICE. 2778 01:54:56,200 --> 01:55:00,160 SO, FROM THE WNT PERSPECTIVE, 2779 01:55:00,160 --> 01:55:04,360 WHAT WE'RE WORKING ON, EACH YEAR 2780 01:55:04,360 --> 01:55:06,640 WE MEET, MEMBER COUNTRIES WORK 2781 01:55:06,640 --> 01:55:11,800 TO DEVELOP AND THEN APPROVE AND 2782 01:55:11,800 --> 01:55:14,920 HARMONIZE THE TEST GUIDELINES 2783 01:55:14,920 --> 01:55:17,800 THAT WILL BE ADOPTED AND USED BY 2784 01:55:17,800 --> 01:55:19,440 MEMBER COUNTRIES, IN SUPPORTING 2785 01:55:19,440 --> 01:55:19,640 THAT. 2786 01:55:19,640 --> 01:55:22,720 NEXT SLIDE PLEASE. 2787 01:55:22,720 --> 01:55:26,320 SO WE HELD A MEETING LAST MONTH, 2788 01:55:26,320 --> 01:55:31,280 ANDING BIG THANKS TO NICOLE WHS 2789 01:55:31,280 --> 01:55:34,880 THERE IN PERSON. 2790 01:55:34,880 --> 01:55:35,760 I WAS PARTICIPATING REMOTELY. 2791 01:55:35,760 --> 01:55:38,040 IT WAS A GOOD MEETING OVERALL, A 2792 01:55:38,040 --> 01:55:38,960 GOOD MEETING FOR US. 2793 01:55:38,960 --> 01:55:42,520 WE SAW A NUMBER OF DOCUMENTS 2794 01:55:42,520 --> 01:55:48,760 THAT WERE ADDS, SPSF PROPOSALS 2795 01:55:48,760 --> 01:55:50,320 TO THE WORKPLAN, GUIDELINES, 2796 01:55:50,320 --> 01:55:51,600 TEST GUIDELINES THAT WERE 2797 01:55:51,600 --> 01:55:52,920 APPROVED, I'LL TOUCH ON A FEW 2798 01:55:52,920 --> 01:55:55,560 AREAS THE UNITED STATES WAS 2799 01:55:55,560 --> 01:55:58,920 SPECIFICALLY INVOLVED ON THOSE 2800 01:55:58,920 --> 01:56:00,040 DOCUMENTS, MENTIONED ANY 2801 01:56:00,040 --> 01:56:01,560 BUSINESS WE INTRODUCED AND TOUCH 2802 01:56:01,560 --> 01:56:04,880 BASE ON OTHER ITEMS THAT ARE 2803 01:56:04,880 --> 01:56:08,040 COMING AND THINGS OF NOTE THAT 2804 01:56:08,040 --> 01:56:11,760 YOU MIGHT FIND INTERESTING. 2805 01:56:11,760 --> 01:56:12,440 NEXT SLIDE. 2806 01:56:12,440 --> 01:56:15,720 SPSFs, SO I PROVIDED HERE A 2807 01:56:15,720 --> 01:56:17,600 LIST OF THE DIFFERENT PROPOSALS 2808 01:56:17,600 --> 01:56:20,880 THAT WERE APPROVED BY THE WNT 2809 01:56:20,880 --> 01:56:24,720 FOR ADDITION TO THE WORK PLAN. 2810 01:56:24,720 --> 01:56:32,080 YOU'LL SEE ON THIS SLIDE THE 2811 01:56:32,080 --> 01:56:35,600 NUMBERS, ONE OF THEM WAS -- 2812 01:56:35,600 --> 01:56:37,680 NUMBER 5 WAS REMOVED. 2813 01:56:37,680 --> 01:56:39,960 EVEN THOUGH THERE ARE 12 GOING 2814 01:56:39,960 --> 01:56:42,920 TO THE WORKPLAN MEMBERSHIP TEAM, 2815 01:56:42,920 --> 01:56:45,000 THE CORRECTIONS TO TEST 2816 01:56:45,000 --> 01:56:45,840 GUIDELINES, THAT'S NOT 2817 01:56:45,840 --> 01:56:47,160 NECESSARILY ADDED TO THE WORK 2818 01:56:47,160 --> 01:56:52,920 PLAN BUT PART OF THE FORMALITY 2819 01:56:52,920 --> 01:56:54,920 OF THE WNT PROCESS BUT I HAVE IN 2820 01:56:54,920 --> 01:56:56,600 FRONT OF ME 12 ADDED TO THE WORK 2821 01:56:56,600 --> 01:56:56,960 PLAN. 2822 01:56:56,960 --> 01:57:00,240 THE U.S. IS LEAD OR CO-LEAD ON 2823 01:57:00,240 --> 01:57:00,560 TWO. 2824 01:57:00,560 --> 01:57:02,160 FIRST WHICH ANNA MENTIONED IN 2825 01:57:02,160 --> 01:57:05,360 HER TALK THIS MORNING IS A 2826 01:57:05,360 --> 01:57:07,080 DETAILED REVIEW PAPER, 2827 01:57:07,080 --> 01:57:10,080 FACILITATE DEVELOPMENT OF TEST 2828 01:57:10,080 --> 01:57:20,400 METHODS, RESPIRATORY 2829 01:57:21,560 --> 01:57:22,760 SENSITIZATION POTENTIAL. 2830 01:57:22,760 --> 01:57:23,400 OUR CURRENT UNDERSTANDING, THE 2831 01:57:23,400 --> 01:57:24,760 PAPER WILL TALK ABOUT OUR 2832 01:57:24,760 --> 01:57:28,360 CURRENT UNDERSTANDING OF THE 2833 01:57:28,360 --> 01:57:29,640 MECHANISMS OF RESPIRATORY 2834 01:57:29,640 --> 01:57:33,400 SENSITIZATION SUMMARIZING MODELS 2835 01:57:33,400 --> 01:57:37,000 AND DIFFERENT APPROACHES AND HOW 2836 01:57:37,000 --> 01:57:38,720 IT ADDRESSES OUR REGULATORY 2837 01:57:38,720 --> 01:57:38,960 NEEDS. 2838 01:57:38,960 --> 01:57:40,360 SO WHAT'S THE CURRENT STATUS 2839 01:57:40,360 --> 01:57:42,360 TODAY, AND I WILL SAY EVEN FROM 2840 01:57:42,360 --> 01:57:44,760 THE FIRST CONVERSATION THERE WAS 2841 01:57:44,760 --> 01:57:47,160 A LOT OF INTEREST AND SUPPORT 2842 01:57:47,160 --> 01:57:49,800 FOR THIS PROJECT. 2843 01:57:49,800 --> 01:57:52,360 IT'S FILLING A GAP AND A NEED 2844 01:57:52,360 --> 01:57:54,320 FOR WHICH THERE'S CURRENTLY NO 2845 01:57:54,320 --> 01:57:55,400 HARMONIZED APPROACH. 2846 01:57:55,400 --> 01:57:59,800 SO WE LOOK FORWARD TO 2847 01:57:59,800 --> 01:58:01,080 DEVELOPMENT OF THIS PROJECT. 2848 01:58:01,080 --> 01:58:05,920 THAT'S ALL I CAN SAY ABOUT THIS 2849 01:58:05,920 --> 01:58:08,760 ONE, IT JUST STARTED BUT WE'RE 2850 01:58:08,760 --> 01:58:10,520 EXCITED TO BE CO-PARTNER WITH 2851 01:58:10,520 --> 01:58:11,480 THE CO-LEADS. 2852 01:58:11,480 --> 01:58:15,240 THE OTHER ONE I WANT TO MENTION 2853 01:58:15,240 --> 01:58:21,040 IS REVISION OF GUIDANCE DOCUMENT 2854 01:58:21,040 --> 01:58:23,120 34, VALIDATION OF ACCEPTANCE. 2855 01:58:23,120 --> 01:58:26,280 GD 34 IS THE FOUNDATIONAL 2856 01:58:26,280 --> 01:58:30,200 GUIDELINE FOR APPROVAL OF TEST 2857 01:58:30,200 --> 01:58:33,600 GUIDELINES, AND AS A WAY TO MAKE 2858 01:58:33,600 --> 01:58:38,640 ANY CHANGES FOR ANY UPDATES TO 2859 01:58:38,640 --> 01:58:39,520 TEST GUIDELINE OECD DOCUMENTS 2860 01:58:39,520 --> 01:58:41,240 HAVE TO MAKE A PROPOSAL. 2861 01:58:41,240 --> 01:58:44,560 SO THE UNITED STATES WITH 2862 01:58:44,560 --> 01:58:46,520 EUROPEAN COMMISSION AND DENMARK 2863 01:58:46,520 --> 01:58:48,280 ARE CO-LEADS ON THIS EFFORT, ALL 2864 01:58:48,280 --> 01:58:51,120 OTHER COUNTRIES WILL BE ENGAGED 2865 01:58:51,120 --> 01:58:58,360 ON THIS BUT NONETHELESS WE'RE 2866 01:58:58,360 --> 01:58:59,880 THE CO-LEADS TO ADDRESS A LOT OF 2867 01:58:59,880 --> 01:59:01,800 POINTS OF THE TEST GUIDELINE 2868 01:59:01,800 --> 01:59:03,240 PROCESS, WHERE, YOU KNOW, IT'S 2869 01:59:03,240 --> 01:59:07,240 BEEN 20 YEARS SINCE THE DOCUMENT 2870 01:59:07,240 --> 01:59:09,400 WAS DEVELOPED, AND SO HOW -- AS 2871 01:59:09,400 --> 01:59:11,800 WITH ANY PROGRAM THERE'S A 2872 01:59:11,800 --> 01:59:14,080 NATURAL EVOLUTION, SO WHERE IS 2873 01:59:14,080 --> 01:59:15,200 THE TEST GUIDELINE PROGRAM 2874 01:59:15,200 --> 01:59:17,400 SUPPORTING OUR CURRENT NEEDS AND 2875 01:59:17,400 --> 01:59:19,800 MAYBE THINGS THAT NEED TO BE 2876 01:59:19,800 --> 01:59:21,520 REFRESHED, SPECIFICALLY WHERE 2877 01:59:21,520 --> 01:59:24,360 CAN WE TURN TO UPDATE THE TEST 2878 01:59:24,360 --> 01:59:26,040 GUIDELINE PROGRAM TO BETTER 2879 01:59:26,040 --> 01:59:26,920 RECEIVE NAMs. 2880 01:59:26,920 --> 01:59:29,320 I'LL SPEAK MORE ABOUT THIS LATER 2881 01:59:29,320 --> 01:59:33,920 BUT THAT'S A TEASE FOR NOW. 2882 01:59:33,920 --> 01:59:36,480 NEXT SLIDE PLEASE. 2883 01:59:36,480 --> 01:59:39,080 AS I MENTIONED, A NUMBER OF TEST 2884 01:59:39,080 --> 01:59:40,800 GUIDELINES AND GUIDANCE 2885 01:59:40,800 --> 01:59:42,160 DOCUMENTS WERE APPROVED BY 2886 01:59:42,160 --> 01:59:45,000 CONSENSUS AT THE MEETING. 2887 01:59:45,000 --> 01:59:50,800 WE'LL HIGHLIGHT ONE HERE, 2888 01:59:50,800 --> 01:59:54,520 REVISION OF TEST GUIDELINE 240, 2889 01:59:54,520 --> 01:59:56,800 MEDAKA AS IT'S KNOWN, DESCRIBES 2890 01:59:56,800 --> 01:59:59,320 TEST BASED ON DISH EXPOSED OVER 2891 01:59:59,320 --> 02:00:01,600 MULTIPLE GENERATIONS TO GIVE 2892 02:00:01,600 --> 02:00:02,960 RELEVANT ECOLOGICAL HAZARD AND 2893 02:00:02,960 --> 02:00:04,880 RISK ASSESSMENT FOR CHEMICALS. 2894 02:00:04,880 --> 02:00:07,320 SO THIS GROUP THAT WAS CO-LEAD 2895 02:00:07,320 --> 02:00:10,680 AT U.S. AND JAPAN WORKED 2896 02:00:10,680 --> 02:00:12,640 TOGETHER TO REVISE THE DOCUMENT, 2897 02:00:12,640 --> 02:00:15,840 YOU KNOW, UPDATE SOME COMPONENTS 2898 02:00:15,840 --> 02:00:18,040 OF IT AND SPECIFICALLY ADD 2899 02:00:18,040 --> 02:00:23,160 ANOTHER ENDPOINT WHICH IS 2900 02:00:23,160 --> 02:00:25,120 EXTENDING THE SECOND GENERATION 2901 02:00:25,120 --> 02:00:26,320 BEYOND HATCH TIME SO AGAIN 2902 02:00:26,320 --> 02:00:28,520 REALLY PLEASED WITH HOW THIS 2903 02:00:28,520 --> 02:00:30,520 DOCUMENT TURNED OUT AND REALLY 2904 02:00:30,520 --> 02:00:33,320 APPRECIATE THE COLLABORATIVE 2905 02:00:33,320 --> 02:00:38,560 NATURE WE HAD WITH JAPAN. 2906 02:00:38,560 --> 02:00:40,640 NEXT SLIDE PLEASE. 2907 02:00:40,640 --> 02:00:43,320 THIS IS GROUPING OUT DIFFERENT 2908 02:00:43,320 --> 02:00:45,720 DOCUMENTS APPROVED. 2909 02:00:45,720 --> 02:00:48,880 MORE ON THE HEALTH AND STATE 2910 02:00:48,880 --> 02:00:49,160 SIDE. 2911 02:00:49,160 --> 02:00:50,840 MONIQUE MENTIONED THIS DOCUMENT 2912 02:00:50,840 --> 02:00:52,040 IN HER TALK ON DNT. 2913 02:00:52,040 --> 02:00:55,480 UNITED STATES IS ACTIVELY 2914 02:00:55,480 --> 02:00:56,760 ENGAGED WITH NUMEROUS 2915 02:00:56,760 --> 02:01:00,280 ACTIVITIES, AND THIS DOCUMENT, 2916 02:01:00,280 --> 02:01:00,960 THIS DEVELOPMENTAL NEUROTOXICITY 2917 02:01:00,960 --> 02:01:02,680 AND IN VITRO TESTING BATTERY 2918 02:01:02,680 --> 02:01:05,080 AIMS TO DESCRIBE ASSAYS THAT 2919 02:01:05,080 --> 02:01:07,600 COMPRISE THE BATTERY IN TERMS OF 2920 02:01:07,600 --> 02:01:09,280 NEURODEVELOPMENT, PROVIDES 2921 02:01:09,280 --> 02:01:10,920 CRITERIA THAT WILL ALLOW 2922 02:01:10,920 --> 02:01:14,080 EVALUATION OF THE RELEVANCE OF 2923 02:01:14,080 --> 02:01:19,640 THE DATA TO DEVELOPMENTAL 2924 02:01:19,640 --> 02:01:20,400 NEUROTOXICITY. 2925 02:01:20,400 --> 02:01:21,800 DOCUMENT SUPPORTS REGULATORY 2926 02:01:21,800 --> 02:01:23,680 OBLIGATION, HELPS ADDRESS THE 2927 02:01:23,680 --> 02:01:25,560 CHALLENGES TO INTERPRET DNT 2928 02:01:25,560 --> 02:01:29,040 DATA, ALSO HIGHLIGHTS ADVANTAGES 2929 02:01:29,040 --> 02:01:30,480 OF NAMs. 2930 02:01:30,480 --> 02:01:33,000 IT SERVES AS AN IMPORTANT 2931 02:01:33,000 --> 02:01:34,920 MILESTONE FOR US, INTERNATIONAL 2932 02:01:34,920 --> 02:01:39,480 RECOGNITION OF UTILITY OF 2933 02:01:39,480 --> 02:01:41,760 NAMs, FOR DNT AND IT'S 2934 02:01:41,760 --> 02:01:42,400 HOPEFULLY TO ENCOURAGE 2935 02:01:42,400 --> 02:01:45,800 EXPLORATION OF HOW NAMs CAN BE 2936 02:01:45,800 --> 02:01:47,640 USED FOR REGULATORY PURPOSES. 2937 02:01:47,640 --> 02:01:53,120 GREAT MILESTONE FOR THIS BODY OF 2938 02:01:53,120 --> 02:01:54,000 WORK. 2939 02:01:54,000 --> 02:01:56,200 NEXT SLIDE PLEASE. 2940 02:01:56,200 --> 02:01:59,680 SO THIS SLIDE YOU'LL SEE SOME -- 2941 02:01:59,680 --> 02:02:02,200 FOUR TOPICS, GREEN CHECK MARKS. 2942 02:02:02,200 --> 02:02:04,080 WHAT'S INTERESTING IS IT'S 2943 02:02:04,080 --> 02:02:06,120 SHOWING CONTINUITY, IF YOU WERE 2944 02:02:06,120 --> 02:02:09,320 HERE LAST YEAR I MENTIONED THESE 2945 02:02:09,320 --> 02:02:10,960 FOUR TOPICS. 2946 02:02:10,960 --> 02:02:12,280 AND SO IT'S INTERESTING TO SEE 2947 02:02:12,280 --> 02:02:13,800 LIKE THERE HAS BEEN PROGRESS 2948 02:02:13,800 --> 02:02:15,480 OVER THE PAST YEAR. 2949 02:02:15,480 --> 02:02:16,440 GREEN CHECK MARK INDICATES THIS 2950 02:02:16,440 --> 02:02:18,320 IS WHAT WE TALKED ABOUT LAST 2951 02:02:18,320 --> 02:02:20,480 YEAR, WHAT HAS HAPPENED OVER THE 2952 02:02:20,480 --> 02:02:21,480 PAST YEAR. 2953 02:02:21,480 --> 02:02:26,280 AND WHERE WE'RE HEADED. 2954 02:02:26,280 --> 02:02:34,840 SO, THE OMICS FRAMEWORK WAS A 2955 02:02:34,840 --> 02:02:37,800 MODULE, AND SO THOSE HAVE BEEN 2956 02:02:37,800 --> 02:02:39,440 DEVELOPED, DRAFT HAS BEEN I 2957 02:02:39,440 --> 02:02:41,920 GUESS YOU COULD SAY MADE 2958 02:02:41,920 --> 02:02:42,200 AVAILABLE. 2959 02:02:42,200 --> 02:02:43,920 AND NOW U.S. IS INVOLVED IN 2960 02:02:43,920 --> 02:02:45,760 TRIALS TO INCORPORATE DIFFERENT 2961 02:02:45,760 --> 02:02:48,200 DATA SOURCES INTO THIS 2962 02:02:48,200 --> 02:02:50,800 FRAMEWORK. 2963 02:02:50,800 --> 02:02:52,680 WE THINK IT INCREASES 2964 02:02:52,680 --> 02:02:54,560 REPRODUCIBILITY OF OMICS 2965 02:02:54,560 --> 02:02:56,800 ANALYSIS, AND WE'RE EXCITED THAT 2966 02:02:56,800 --> 02:02:57,960 THIS REGULATORY TOOL WILL BE 2967 02:02:57,960 --> 02:03:00,000 AVAILABLE, STILL IN THE TRIALING 2968 02:03:00,000 --> 02:03:02,320 STAGE TO CONFIRM ITS UTILITY, 2969 02:03:02,320 --> 02:03:03,720 CHECK FOR BUGS, AND IMPROVE 2970 02:03:03,720 --> 02:03:04,480 GUIDANCE DOCUMENT. 2971 02:03:04,480 --> 02:03:07,240 HOWEVER, WE EXPECT THIS COULD BE 2972 02:03:07,240 --> 02:03:08,680 COMING OUT AND MADE AVAILABLE 2973 02:03:08,680 --> 02:03:09,440 SOON. 2974 02:03:09,440 --> 02:03:10,960 IN THE MEANTIME YOU CAN FOLLOW 2975 02:03:10,960 --> 02:03:17,520 THE WEB LINK AND SEE WHERE THEY 2976 02:03:17,520 --> 02:03:18,400 ARE. 2977 02:03:18,400 --> 02:03:20,480 THYROID METHOD, DISRUPTION 2978 02:03:20,480 --> 02:03:22,360 GROUP, LAST YEAR JUST FORMED SO 2979 02:03:22,360 --> 02:03:26,400 WORKING ON VALIDATION 2980 02:03:26,400 --> 02:03:29,920 ACTIVITIES, THYROID DESTRUCTION, 2981 02:03:29,920 --> 02:03:32,200 BATTERIES OF ASSAYS, HELD A 2982 02:03:32,200 --> 02:03:36,360 MEETING LAST WEEK, FIRST BIG 2983 02:03:36,360 --> 02:03:39,320 MEETING, TO DISCUSS OUTCOME OF 2984 02:03:39,320 --> 02:03:45,320 ASSAYS DISCUSSED AND NEXT STEPS. 2985 02:03:45,320 --> 02:03:47,280 WNT WILL BE INFORMED OF WHAT 2986 02:03:47,280 --> 02:03:50,800 THEY DISCUSSED AND I'M SURE MADE 2987 02:03:50,800 --> 02:03:56,720 AVAILABLE IN THE NEAR FUTURE. 2988 02:03:56,720 --> 02:03:59,360 NEXT ONE IS -- LAST YEAR, THIS 2989 02:03:59,360 --> 02:04:09,880 IS THE LAST TIME YOU'LL SEE THIS 2990 02:04:13,440 --> 02:04:16,720 ACRONYM, EAGMST, REPLACED BY 2991 02:04:16,720 --> 02:04:16,920 ESCA. 2992 02:04:16,920 --> 02:04:20,040 IT WAS AN ADVISORY GROUP, A LOT 2993 02:04:20,040 --> 02:04:27,320 OF ACTIVITY, BUT IT NEEDED TO BE 2994 02:04:27,320 --> 02:04:31,080 REVISED, REFRESHED TO BETTER 2995 02:04:31,080 --> 02:04:36,320 HELP SUPPORT WNT AND WPHA, A 2996 02:04:36,320 --> 02:04:38,480 WORKING PARTY FOR HAZARD 2997 02:04:38,480 --> 02:04:42,120 ASSESSMENT, NOW ESPA IS 2998 02:04:42,120 --> 02:04:44,960 RESPONSIBLE FOR WPHA AND WNT, 2999 02:04:44,960 --> 02:04:46,160 ADVISORY CAPACITY, LOOKING 3000 02:04:46,160 --> 02:04:49,440 FORWARD, APPLICATION OF EMERGING 3001 02:04:49,440 --> 02:04:50,960 SCIENCE. 3002 02:04:50,960 --> 02:04:55,240 WHAT'S REALLY EXCITING IS THAT 3003 02:04:55,240 --> 02:04:59,720 IT WILL BE LIKE, YOU KNOW, MORE 3004 02:04:59,720 --> 02:05:00,600 COORDINATION, MORE TRANSPARENCY, 3005 02:05:00,600 --> 02:05:03,960 MORE DIRECTION IN A WAY, WHERE 3006 02:05:03,960 --> 02:05:06,520 THERE WAS -- THERE WERE A LOT OF 3007 02:05:06,520 --> 02:05:08,040 PROJECTS HAPPENING, MAYBE FOLKS 3008 02:05:08,040 --> 02:05:09,280 DIDN'T UNDERSTAND HOW THEY 3009 02:05:09,280 --> 02:05:10,800 ALIGNED OR WERE SUPPORTED. 3010 02:05:10,800 --> 02:05:13,320 NOW WITH INCREASED COORDINATION 3011 02:05:13,320 --> 02:05:15,040 AND TRANSPARENCY LOOKING AT 3012 02:05:15,040 --> 02:05:21,000 DEVELOPING NEW AOPs, IATAs 3013 02:05:21,000 --> 02:05:28,920 OR NAMs, THERE'S A MORE FORMAL 3014 02:05:28,920 --> 02:05:31,040 PROCESS, OPERATING MODEL FOR 3015 02:05:31,040 --> 02:05:31,600 DIRECTED WORK. 3016 02:05:31,600 --> 02:05:33,520 WHAT'S ALSO INTERESTING IS WE'VE 3017 02:05:33,520 --> 02:05:36,520 HEARD TODAY ABOUT THE WORK WITH 3018 02:05:36,520 --> 02:05:37,360 NAMs. 3019 02:05:37,360 --> 02:05:40,760 WE HEARD FROM CPSC, FDA, AND 3020 02:05:40,760 --> 02:05:42,960 OTHERS, AND THIS IS WHERE ESCA 3021 02:05:42,960 --> 02:05:44,280 IS GOING TO MIRROR WHERE THE 3022 02:05:44,280 --> 02:05:54,560 UNITED STATES IS MOVING TOWARDS 3023 02:05:54,560 --> 02:05:55,880 MORE COORDINATED, THROUGH 3024 02:05:55,880 --> 02:05:58,080 ICCVAM, LOOKING AT METHODS AND 3025 02:05:58,080 --> 02:06:01,800 NEW SCIENCE FOR CHEMICAL SAFETY 3026 02:06:01,800 --> 02:06:04,400 ASSESSMENT. 3027 02:06:04,400 --> 02:06:06,520 AND SO THE NEXT ONE, I TOLD YOU 3028 02:06:06,520 --> 02:06:09,120 I'D GET BACK TO THIS. 3029 02:06:09,120 --> 02:06:13,160 EMERGING TECHNOLOGIES IS THE 3030 02:06:13,160 --> 02:06:14,720 GUIDANCE DOCUMENT 34. 3031 02:06:14,720 --> 02:06:17,000 SO WE'RE WORKING TOWARDS 3032 02:06:17,000 --> 02:06:18,200 IMPROVING TEST GUIDELINE PROGRAM 3033 02:06:18,200 --> 02:06:22,160 AND REVIEW OF NAMs, AND THIS 3034 02:06:22,160 --> 02:06:26,080 PROPOSED REVISION TO DOCUMENT 34 3035 02:06:26,080 --> 02:06:26,960 WILL ENTAIL RECOMMENDATIONS 3036 02:06:26,960 --> 02:06:29,040 DERIVED FROM WNT, FROM THE 3037 02:06:29,040 --> 02:06:30,800 WORKSHOP THAT WE HELD FROM 3038 02:06:30,800 --> 02:06:33,920 PRACTICAL EXPERIENCE, AND OTHER 3039 02:06:33,920 --> 02:06:37,240 LESSONS LEARNED, PUBLISHED 3040 02:06:37,240 --> 02:06:39,200 WITHIN THE LITERATURE, ON WHERE 3041 02:06:39,200 --> 02:06:41,320 CAN THE PROGRAM AND THE PROCESS 3042 02:06:41,320 --> 02:06:42,520 BE IMPROVED. 3043 02:06:42,520 --> 02:06:48,960 OVER THE PAST YEAR THE WNT AND 3044 02:06:48,960 --> 02:06:50,160 U.S. TEAM, ALLISON, YOU'RE IN 3045 02:06:50,160 --> 02:06:54,760 THE ROOM AS WELL, ON THIS 3046 02:06:54,760 --> 02:06:56,400 STEERING GROUP TO, YOU KNOW, TRY 3047 02:06:56,400 --> 02:07:00,560 TO FIND OUT HOW CAN WE APPROACH 3048 02:07:00,560 --> 02:07:01,440 THIS LARGE TOPIC, RECOGNIZING 3049 02:07:01,440 --> 02:07:03,400 IT'S GOING TO BE A LONG 3050 02:07:03,400 --> 02:07:06,040 CONVERSATION, WE HELD SIX 3051 02:07:06,040 --> 02:07:08,520 WEBINARS LAST YEAR, TRIED TO GET 3052 02:07:08,520 --> 02:07:09,920 EVERYBODY -- LIKE WHEN WE SAY 3053 02:07:09,920 --> 02:07:12,600 REPRODUCIBILITY, WHAT DO WE 3054 02:07:12,600 --> 02:07:12,920 MEAN? 3055 02:07:12,920 --> 02:07:14,920 DO WE ALL -- ARE WE THINKING THE 3056 02:07:14,920 --> 02:07:16,640 SAME THING? 3057 02:07:16,640 --> 02:07:17,960 HOW DO WE DEFINE WHERE THERE 3058 02:07:17,960 --> 02:07:22,120 MIGHT BE A CHALLENGE ON ISSUE OR 3059 02:07:22,120 --> 02:07:23,440 BARRIER, AND THEN LET'S RESTORE 3060 02:07:23,440 --> 02:07:25,280 SOME WAYS TO OVERCOME. 3061 02:07:25,280 --> 02:07:29,560 SIX WEBINARS LAST YEAR, YOU CAN 3062 02:07:29,560 --> 02:07:31,640 GO TO THE WNT WEB PAGE AND 3063 02:07:31,640 --> 02:07:33,000 REVIEW ALL OF THOSE COVERING 3064 02:07:33,000 --> 02:07:42,880 GOOD IN VITRO METHOD PRACTICES, 3065 02:07:42,880 --> 02:07:43,680 ECOTOXICOLOGY, PROBABILISTIC 3066 02:07:43,680 --> 02:07:45,200 MODELING, WE DISCUSSED ALL THOSE 3067 02:07:45,200 --> 02:07:50,000 TOPICS AND THEN USED WHAT WE 3068 02:07:50,000 --> 02:07:54,080 LEARNED FROM THOSE WEBINARS, 3069 02:07:54,080 --> 02:07:56,040 INFORM OUR STRUCTURE FOR 3070 02:07:56,040 --> 02:07:59,200 DISCUSSION AT THE WORKSHOP HELD 3071 02:07:59,200 --> 02:08:01,720 IN DECEMBER 2022, TALKING ABOUT 3072 02:08:01,720 --> 02:08:06,080 THE SAME THINGS, TEST READINESS, 3073 02:08:06,080 --> 02:08:09,960 PERFORMANCE STANDARDS, BATTERIES 3074 02:08:09,960 --> 02:08:11,680 OF ASSAYS, INCENTIVIZING 3075 02:08:11,680 --> 02:08:13,440 VALIDATION STUDIES, THOSE 3076 02:08:13,440 --> 02:08:17,040 DISCUSSIONS THEN WILL HELP US 3077 02:08:17,040 --> 02:08:19,480 FOR THIS YEAR SO NOW THAT THE 3078 02:08:19,480 --> 02:08:21,640 SPSF PROPOSAL HAS BEEN APPROVED 3079 02:08:21,640 --> 02:08:24,080 WE WILL BE MOVING FORWARD WITH 3080 02:08:24,080 --> 02:08:24,720 SOME RECOMMENDATIONS THAT CAME 3081 02:08:24,720 --> 02:08:29,960 OUT OF THE WORKSHOP TO TACKLE 3082 02:08:29,960 --> 02:08:31,600 AND ADDRESS THESE TOPICS TO SEE 3083 02:08:31,600 --> 02:08:33,800 HOW THEY SHOULD BE OR WHERE THEY 3084 02:08:33,800 --> 02:08:39,840 NEED TO BE IF THEY NEED TO BE 3085 02:08:39,840 --> 02:08:41,400 UPDATED OR REVISED IN THE 3086 02:08:41,400 --> 02:08:42,320 GUIDANCE DOCUMENT, JUST AS A 3087 02:08:42,320 --> 02:08:44,400 GENERAL RULE OF PRACTICE AS WELL 3088 02:08:44,400 --> 02:08:50,720 AS BETTER ACCOMMODATE FOR 3089 02:08:50,720 --> 02:08:51,080 NAMs. 3090 02:08:51,080 --> 02:08:54,120 WHAT'S EXCITING WE HAVE THIS 3091 02:08:54,120 --> 02:08:55,360 BODY HERE, RIGHT? 3092 02:08:55,360 --> 02:08:58,520 THROUGH THE WORK THAT WE'RE 3093 02:08:58,520 --> 02:08:59,480 DOING ACROSS THE FEDERAL 3094 02:08:59,480 --> 02:09:01,120 GOVERNMENT BUT INDIVIDUALLY AND 3095 02:09:01,120 --> 02:09:04,000 COLLECTIVELY AND THROUGH ICCVAM 3096 02:09:04,000 --> 02:09:08,360 THAT WE'RE GOING TO HELP INFORM 3097 02:09:08,360 --> 02:09:09,640 THE REVISIONS TO GUIDANCE 3098 02:09:09,640 --> 02:09:10,320 DOCUMENT 34. 3099 02:09:10,320 --> 02:09:13,160 THERE'S GOING TO BE A LONG 3100 02:09:13,160 --> 02:09:15,240 CONVERSATION AND WE LOOK FORWARD 3101 02:09:15,240 --> 02:09:18,000 TO WORKING WITH EVERYBODY HERE 3102 02:09:18,000 --> 02:09:23,720 ON AS WE REVISE THAT DOCUMENT. 3103 02:09:23,720 --> 02:09:24,920 NEXT SLIDE PLEASE. 3104 02:09:24,920 --> 02:09:30,720 WRAPPING UP WITH A FEW OTHER 3105 02:09:30,720 --> 02:09:33,680 ITEMS, WANTED TO NOTE, THE OTHER 3106 02:09:33,680 --> 02:09:36,400 WORKING PARTIES, GOOD LABORATORY 3107 02:09:36,400 --> 02:09:39,240 PRACTICES, THEY PUBLISHED A 3108 02:09:39,240 --> 02:09:44,640 DOCUMENT, GLP AND CLOUD 3109 02:09:44,640 --> 02:09:45,840 COMPUTING, OUTLINES 3110 02:09:45,840 --> 02:09:48,560 RESPONSIBILITIES, COMPLIANCE TO 3111 02:09:48,560 --> 02:09:50,640 GLP PRINCIPLES USING CLOUD-BASED 3112 02:09:50,640 --> 02:09:50,880 SOLUTIONS. 3113 02:09:50,880 --> 02:09:52,840 WHAT'S INTERESTING, YOU CAN'T 3114 02:09:52,840 --> 02:09:55,240 SET A STANDARD FOR MUST USE A 3115 02:09:55,240 --> 02:09:56,880 CERTAIN TYPE OF SYSTEM, BUT WHAT 3116 02:09:56,880 --> 02:10:00,800 THEY ARE TRYING TO DO IS 3117 02:10:00,800 --> 02:10:03,120 RECOGNIZING WITH WHATEVER RISKS 3118 02:10:03,120 --> 02:10:04,880 AND VULNERABILITIES WITH YOUR 3119 02:10:04,880 --> 02:10:06,960 SYSTEM AND ENSURING YOUR DATA 3120 02:10:06,960 --> 02:10:11,400 INTEGRITY, WHAT THEY ARE ALSO 3121 02:10:11,400 --> 02:10:14,240 MOVING TOWARDS ARE STARTING 3122 02:10:14,240 --> 02:10:20,400 DISCUSSIONS ON GLP FOR EMERGING 3123 02:10:20,400 --> 02:10:25,760 TECHNOLOGIES, NOT TRYING TO MEET 3124 02:10:25,760 --> 02:10:27,760 CERTAIN I GUESS TECHNICAL 3125 02:10:27,760 --> 02:10:30,360 PERFORMANCE, MORE LIKE A 3126 02:10:30,360 --> 02:10:33,000 CHECKLIST OR DECISION TREE WHERE 3127 02:10:33,000 --> 02:10:34,680 INSPECTORS OF EMERGING 3128 02:10:34,680 --> 02:10:35,840 TECHNOLOGIES AND TEST FACILITIES 3129 02:10:35,840 --> 02:10:39,040 TO ENSURE HAVE YOU THOUGHT HOW 3130 02:10:39,040 --> 02:10:40,760 YOU'RE ADDRESSING VULNERABILITY, 3131 02:10:40,760 --> 02:10:42,880 THAT'S A HEADS UP, SOMETHING 3132 02:10:42,880 --> 02:10:47,120 THEY HAVE DEVELOPED AND SEE THAT 3133 02:10:47,120 --> 02:10:48,880 COULD BE POTENTIAL FOR FURTHER 3134 02:10:48,880 --> 02:10:50,960 DISCUSSION IN THE FUTURE. 3135 02:10:50,960 --> 02:10:53,080 LAST TWO ITEMS ARE ANY OTHER 3136 02:10:53,080 --> 02:10:56,000 BUSINESS, SO AT THE END OF THE 3137 02:10:56,000 --> 02:10:58,280 WNT MEETING THERE'S AN 3138 02:10:58,280 --> 02:10:59,280 OPPORTUNITY FOR PEOPLE TO 3139 02:10:59,280 --> 02:11:01,000 INTRODUCE ANY OTHER BUSINESS. 3140 02:11:01,000 --> 02:11:03,200 SO THE UNITED STATES, WE OFFERED 3141 02:11:03,200 --> 02:11:04,200 TWO DIFFERENT TOPICS FOR ANY 3142 02:11:04,200 --> 02:11:05,080 OTHER BUSINESS. 3143 02:11:05,080 --> 02:11:08,240 ONE WAS A RECAP OF A WORKSHOP 3144 02:11:08,240 --> 02:11:15,560 HELD IN MARCH OF THIS YEAR 3145 02:11:15,560 --> 02:11:16,920 PROVIDING STATUS WHERE, YOU 3146 02:11:16,920 --> 02:11:22,840 KNOW, ESPECIALLY ROADMAP AND 3147 02:11:22,840 --> 02:11:27,520 INTEGRATION OF ECGs, WE HAD 3148 02:11:27,520 --> 02:11:28,960 CO-ORGANIZERS FROM NATIONAL 3149 02:11:28,960 --> 02:11:30,600 TOXICOLOGY PROGRAM, AS WELL WITH 3150 02:11:30,600 --> 02:11:32,800 JOHNS HOPKINS CENTER FOR 3151 02:11:32,800 --> 02:11:34,880 ALTERNATIVES ANIMAL TESTINGS, 3152 02:11:34,880 --> 02:11:35,760 REPRESENTATIVES AND PARTICIPANTS 3153 02:11:35,760 --> 02:11:37,720 FROM ACROSS FEDERAL GOVERNMENT, 3154 02:11:37,720 --> 02:11:42,440 AS WELL AS SOME OF OUR PHARMA 3155 02:11:42,440 --> 02:11:44,760 PARTNERS AND TALKING ABOUT SOME 3156 02:11:44,760 --> 02:11:46,560 CHALLENGES TO IMPLEMENTATION 3157 02:11:46,560 --> 02:11:50,960 LIKE DATA CURATION TERMINOLOGY 3158 02:11:50,960 --> 02:11:52,240 ISSUES, LACK OF VALIDATION, AND 3159 02:11:52,240 --> 02:11:55,120 GENETIC DRIFT OR OTHER 3160 02:11:55,120 --> 02:11:55,880 BIOLOGICAL FACTORS. 3161 02:11:55,880 --> 02:12:01,880 SO PROVIDING AN UPDATE FROM THAT 3162 02:12:01,880 --> 02:12:02,560 MEETING. 3163 02:12:02,560 --> 02:12:04,880 AND THEN THE HISTORICAL CONTROL 3164 02:12:04,880 --> 02:12:06,360 DATA, ANOTHER TOPIC WE 3165 02:12:06,360 --> 02:12:07,360 INTRODUCED, LOOKING AT -- 3166 02:12:07,360 --> 02:12:13,600 THERE'S A GROUP WHO WILL LIKELY 3167 02:12:13,600 --> 02:12:15,480 BE PRESENTING SPSF THIS FALL 3168 02:12:15,480 --> 02:12:18,080 THAT IS LOOKING AT IN VIVO 3169 02:12:18,080 --> 02:12:18,960 HISTORICAL NEGATIVE CONTROL 3170 02:12:18,960 --> 02:12:22,680 DATA, SPECIFICALLY FOR THIS 3171 02:12:22,680 --> 02:12:25,200 GROUP LOOKING AT GENETIC 3172 02:12:25,200 --> 02:12:27,040 TOXICOLOGY, BUT I THINK WHAT'S 3173 02:12:27,040 --> 02:12:30,560 TELLING IS THAT WHAT THEY ARE 3174 02:12:30,560 --> 02:12:31,640 FINDING THAT, YOU KNOW, WE DON'T 3175 02:12:31,640 --> 02:12:35,920 HAVE A LOT OF GUIDANCE HOW TO 3176 02:12:35,920 --> 02:12:38,040 USE HISTORICAL CONTROL DATA AND 3177 02:12:38,040 --> 02:12:39,240 EVALUATE THE QUANTITY AND 3178 02:12:39,240 --> 02:12:49,720 CALCULATE INTERVALS THAT ARE 3179 02:12:51,000 --> 02:12:52,480 ACTUALLY HERITABLE. 3180 02:12:52,480 --> 02:12:54,000 IT HAS BROADER APPLICATION 3181 02:12:54,000 --> 02:12:57,080 BEYOND THEIR FOCUS OF GENE TOX, 3182 02:12:57,080 --> 02:12:58,040 SO IT'S SOMETHING WE'RE 3183 02:12:58,040 --> 02:12:59,920 INTERESTED IN SEEING HOW IT 3184 02:12:59,920 --> 02:13:01,120 EVOLVED AS WELL. 3185 02:13:01,120 --> 02:13:02,840 IT DOES PROMPT ME TO REMIND 3186 02:13:02,840 --> 02:13:04,840 EVERYBODY IF YOU HAVE AN IDEA 3187 02:13:04,840 --> 02:13:10,000 THAT YOU WOULD LIKE TO SEND 3188 02:13:10,000 --> 02:13:12,520 FORWARD, THE SPSF PROPOSALS ARE 3189 02:13:12,520 --> 02:13:13,720 DUE TO THE SECRETARIAT BY 3190 02:13:13,720 --> 02:13:20,080 NOVEMBER 15 OF THIS YEAR, 2023. 3191 02:13:20,080 --> 02:13:22,680 YOU CAN FIND MORE INFORMATION AT 3192 02:13:22,680 --> 02:13:24,760 THE LINK OR CONTACT ME DIRECTLY. 3193 02:13:24,760 --> 02:13:25,560 NEXT SLIDE, WHICH IS QUESTIONS. 3194 02:13:25,560 --> 02:13:27,320 I DON'T KNOW IF WE'RE TAKING 3195 02:13:27,320 --> 02:13:29,280 THOSE NOW OR WAITING TILL LATER. 3196 02:13:29,280 --> 02:13:33,640 >> SURE, WE CAN TAKE QUESTIONS 3197 02:13:33,640 --> 02:13:34,000 NOW. 3198 02:13:34,000 --> 02:13:36,040 I WILL JUST, FORGIVE ME, 3199 02:13:36,040 --> 02:13:37,840 CHARLES, MAKE ONE SMALL 3200 02:13:37,840 --> 02:13:38,120 CORRECTION. 3201 02:13:38,120 --> 02:13:40,640 >> OH, PLEASE DO, YEAH. 3202 02:13:40,640 --> 02:13:43,840 >> WE'RE CO-LEADING THE GD 34 3203 02:13:43,840 --> 02:13:46,080 REVISION PROJECT WITH EUROPEAN 3204 02:13:46,080 --> 02:13:49,520 COMMISSION AND NETHERLANDS, NOT 3205 02:13:49,520 --> 02:13:50,320 DENMARK. 3206 02:13:50,320 --> 02:13:52,120 THAT BEING SAID, IT WAS 3207 02:13:52,120 --> 02:13:55,320 IMPORTANT PART OF THE ENTIRE WNT 3208 02:13:55,320 --> 02:13:56,320 DISCUSSION THAT BECAUSE AS YOU 3209 02:13:56,320 --> 02:14:00,240 INDICATED THIS IS SUCH A 3210 02:14:00,240 --> 02:14:00,920 FOUNDATIONAL DOCUMENT FOR 3211 02:14:00,920 --> 02:14:03,000 VALIDATIONAL METHODS INTENDED TO 3212 02:14:03,000 --> 02:14:05,160 GO INTO OECD TEST GUIDELINES, 3213 02:14:05,160 --> 02:14:07,680 EXPECTATION IS THE EXPERT GROUP 3214 02:14:07,680 --> 02:14:09,440 FORMED TO REALLY OVERSEE AND 3215 02:14:09,440 --> 02:14:12,280 CONTRIBUTE TO THE REVISION OF GD 3216 02:14:12,280 --> 02:14:14,240 34 WILL BE COMPRISED OF THE 3217 02:14:14,240 --> 02:14:17,320 ENTIRE WNT AND WHATEVER SUBJECT 3218 02:14:17,320 --> 02:14:20,360 MATTER EXPERTS ON VALIDATION 3219 02:14:20,360 --> 02:14:23,920 THAT RESPECTIVE COUNTRIES DECIDE 3220 02:14:23,920 --> 02:14:24,520 TO NOMINATE, A SMALL 3221 02:14:24,520 --> 02:14:32,120 ♪ -- SMALL NOTE THERE. 3222 02:14:32,120 --> 02:14:33,400 ANY QUESTIONS FOR CHARLES, IN 3223 02:14:33,400 --> 02:14:38,560 THE ROOM OR ELSEWHERE? 3224 02:14:38,560 --> 02:14:40,200 THANK YOU, CHARLES. 3225 02:14:40,200 --> 02:14:46,880 THAT WAS EXCELLENT. 3226 02:14:46,880 --> 02:14:49,880 SO I WANT TO MAKE A NOTE THAT WE 3227 02:14:49,880 --> 02:14:54,040 HAVE HAD A NUMBER OF QUESTIONS 3228 02:14:54,040 --> 02:14:56,200 COME IN ONLINE, OVER THE LUNCH 3229 02:14:56,200 --> 02:14:56,520 BREAK. 3230 02:14:56,520 --> 02:14:58,720 SO WE WILL GET TO THOSE 3231 02:14:58,720 --> 02:15:03,360 QUESTIONS BEFORE WE TAKE OUR 3232 02:15:03,360 --> 02:15:04,360 MID-AFTERNOON BREAK. 3233 02:15:04,360 --> 02:15:05,040 SO WE UNFORTUNATELY STILL DON'T 3234 02:15:05,040 --> 02:15:06,400 HAVE OUR COLLEAGUES FROM THE 3235 02:15:06,400 --> 02:15:08,280 V.A. OFFICE OF RESEARCH AND 3236 02:15:08,280 --> 02:15:11,120 DEVELOPMENT SO WE'RE GOING TO GO 3237 02:15:11,120 --> 02:15:12,960 TO -- AS YOU ALL WILL RECALL, 3238 02:15:12,960 --> 02:15:14,040 OUR COLLEAGUE FROM THE 3239 02:15:14,040 --> 02:15:15,160 DEPARTMENT OF THE INTERIOR WAS 3240 02:15:15,160 --> 02:15:17,240 KIND ENOUGH TO SWITCH HER 3241 02:15:17,240 --> 02:15:18,440 PRESENTATION TO BEFORE LUNCH, SO 3242 02:15:18,440 --> 02:15:23,440 NOW WE'RE GOING TO GO TO DR. 3243 02:15:23,440 --> 02:15:25,120 ELIJAH PETERSEN FROM NATIONAL 3244 02:15:25,120 --> 02:15:26,520 INSTITUTE OF STANDARDS AND 3245 02:15:26,520 --> 02:15:27,840 TECHNOLOGY. 3246 02:15:27,840 --> 02:15:30,720 YOU'LL BE SHARING YOUR SLIDES 3247 02:15:30,720 --> 02:15:32,080 DIRECTLY, IS THAT CORRECT? 3248 02:15:32,080 --> 02:15:34,080 >> SURE. 3249 02:15:34,080 --> 02:15:34,400 I CAN DO THAT. 3250 02:15:34,400 --> 02:15:35,600 CAN YOU HEAR ME OKAY? 3251 02:15:35,600 --> 02:15:36,920 >>WE CAN HEAR YOU GREAT. 3252 02:15:36,920 --> 02:15:39,960 AND WE CAN SEE YOU VERY WELL. 3253 02:15:39,960 --> 02:15:41,080 >> OH, GOOD. 3254 02:15:41,080 --> 02:15:43,600 LET'S SEE. 3255 02:15:43,600 --> 02:15:49,640 3256 02:15:49,640 --> 02:15:54,000 3257 02:15:54,000 --> 02:15:55,680 I'M NOT SEEING HOW TO SHARE WHAT 3258 02:15:55,680 --> 02:15:58,360 I WANT TO BE SHARING. 3259 02:15:58,360 --> 02:16:00,920 >> YOU DON'T SEE THE GREEN 3260 02:16:00,920 --> 02:16:01,600 SHARE SCREEN BUTTON? 3261 02:16:01,600 --> 02:16:06,400 I DO BUT MY PRESENTATION IS 3262 02:16:06,400 --> 02:16:09,280 NOT POPPING UP. 3263 02:16:09,280 --> 02:16:11,040 I DID E-MAIL STEPHEN SO 3264 02:16:11,040 --> 02:16:12,920 HOPEFULLY YOU SHOULD HAVE IT. 3265 02:16:12,920 --> 02:16:21,000 >> OKAY. 3266 02:16:21,000 --> 02:16:29,200 3267 02:16:29,200 --> 02:16:30,880 >> I COULD TRY TO SHARE MY 3268 02:16:30,880 --> 02:16:32,800 SCREEN AND GO OVER THE 3269 02:16:32,800 --> 02:16:33,120 PRESENTATION. 3270 02:16:33,120 --> 02:16:34,680 MAYBE I'LL TRY THAT. 3271 02:16:34,680 --> 02:16:35,720 IS THAT WORKING? 3272 02:16:35,720 --> 02:16:37,280 >>LOOKS GREAT, YEP. 3273 02:16:37,280 --> 02:16:38,280 >> OKAY. 3274 02:16:38,280 --> 02:16:38,480 GREAT. 3275 02:16:38,480 --> 02:16:40,560 MY APOLOGIES FOR NOT BEING IN 3276 02:16:40,560 --> 02:16:41,320 PERSON. 3277 02:16:41,320 --> 02:16:44,160 I'M ALSO, LIKE CHARLES, I HAVE A 3278 02:16:44,160 --> 02:16:45,920 BIT OF A BIOLOGIC BUG RUNNING 3279 02:16:45,920 --> 02:16:47,120 AROUND THIS HOUSEHOLD SO I 3280 02:16:47,120 --> 02:16:49,000 DIDN'T WANT TO GET EVERYONE ELSE 3281 02:16:49,000 --> 02:16:52,280 SICK. 3282 02:16:52,280 --> 02:16:54,360 SO I'LL JUMP RIGHT IN. 3283 02:16:54,360 --> 02:16:57,440 HAPPY TO SHARE ON BEHALF OF 3284 02:16:57,440 --> 02:16:59,160 MYSELF AND MY COLLEAGUE JOHN 3285 02:16:59,160 --> 02:17:02,760 ELLIOTT WHAT WE'VE BEEN UP TO AT 3286 02:17:02,760 --> 02:17:04,080 NIST WITH MEASUREMENT SCIENCE 3287 02:17:04,080 --> 02:17:08,840 ACTIVITIES AND ICCVAM. 3288 02:17:08,840 --> 02:17:13,120 SO, I THINK WE WORKED ON A 3289 02:17:13,120 --> 02:17:14,600 TECHNICAL FRAMEWORK MANUSCRIPT, 3290 02:17:14,600 --> 02:17:15,800 A GOVERNMENT-WIDE EFFORT WITH A 3291 02:17:15,800 --> 02:17:19,520 NUMBER OF COLLEAGUES FROM 3292 02:17:19,520 --> 02:17:21,080 DIFFERENT AGENCIES INCLUDING 3293 02:17:21,080 --> 02:17:24,000 NIST AND INTERNATIONAL 3294 02:17:24,000 --> 02:17:29,480 COLLEAGUE, HAPPY TO SHARE THAT, 3295 02:17:29,480 --> 02:17:32,320 THIS PAPER DISCUSSING QUALITY 3296 02:17:32,320 --> 02:17:34,440 SIDE OF HELPING DEVELOP METHODS 3297 02:17:34,440 --> 02:17:37,600 PUBLISHED LAST YEAR IN ALTEX, 3298 02:17:37,600 --> 02:17:39,440 CAME OUT IN THE JANUARY EDITION 3299 02:17:39,440 --> 02:17:40,080 THIS YEAR. 3300 02:17:40,080 --> 02:17:44,360 I'LL SHARE MORE ABOUT THAT. 3301 02:17:44,360 --> 02:17:46,040 SO, AGAIN, REALLY A 3302 02:17:46,040 --> 02:17:48,520 COLLABORATIVE EFFORT, A NUMBER 3303 02:17:48,520 --> 02:17:49,400 OF AGENCIES. 3304 02:17:49,400 --> 02:17:51,480 THE GOAL HERE IS TO -- WAS TO 3305 02:17:51,480 --> 02:17:54,960 DESCRIBE A FRAMEWORK FOR HOW TO 3306 02:17:54,960 --> 02:17:56,320 TAKE SOMETHING FROM -- THERE'S 3307 02:17:56,320 --> 02:18:01,680 SO MANY METHODS PUBLISHED IN THE 3308 02:18:01,680 --> 02:18:02,760 LITERATURE, A SMALL FRACTION 3309 02:18:02,760 --> 02:18:06,280 WITH STEPS TO ENABLE TO BE A 3310 02:18:06,280 --> 02:18:08,800 STANDARD, USED FOR MORE ROBUST 3311 02:18:08,800 --> 02:18:09,880 TESTING, LESS OF INFORMATION 3312 02:18:09,880 --> 02:18:12,920 ABOUT THAT ALREADY IN THE 3313 02:18:12,920 --> 02:18:17,960 LITERATURE, INCLUDING SOME LISTS 3314 02:18:17,960 --> 02:18:20,160 SUCH AS KEY CONSIDERATIONS, 3315 02:18:20,160 --> 02:18:23,680 APPLY BASIC QUALITY TOOLS TO 3316 02:18:23,680 --> 02:18:25,520 IMPROVE CONFIDENCE IN NAMs. 3317 02:18:25,520 --> 02:18:29,920 AND STEPS YOU CAN UNDERTAKE, HOW 3318 02:18:29,920 --> 02:18:34,600 RELATE TO EACH OTHER. 3319 02:18:34,600 --> 02:18:36,680 WE DISCUSSED IMPROVE CONFIDENCE 3320 02:18:36,680 --> 02:18:38,240 DECISIONS, INSTEAD OF POSITIVE 3321 02:18:38,240 --> 02:18:39,840 OR NEGATIVE CALL COULD HAVE THAT 3322 02:18:39,840 --> 02:18:40,800 IN ADDITION TO INFORMATION ABOUT 3323 02:18:40,800 --> 02:18:42,600 THE RISK, FOR EXAMPLE, BEING A 3324 02:18:42,600 --> 02:18:44,560 FALSE POSITIVE OR FALSE NEGATIVE 3325 02:18:44,560 --> 02:18:44,880 RESULT. 3326 02:18:44,880 --> 02:18:47,920 SO THAT'S SOMETHING WE THINK 3327 02:18:47,920 --> 02:18:50,720 IS -- WE WANTED TO DESCRIBE AS A 3328 02:18:50,720 --> 02:18:52,000 HELPFUL OPTION TO CONSIDER. 3329 02:18:52,000 --> 02:18:56,000 IT SHOULD BE NOTED THAT THERE 3330 02:18:56,000 --> 02:18:56,800 CAN BE TRADEOFFS. 3331 02:18:56,800 --> 02:18:59,000 FOR EXAMPLE, MAYBE FOR SOME CASE 3332 02:18:59,000 --> 02:19:00,400 MORE CONTROLS COULD LEAD TO 3333 02:19:00,400 --> 02:19:02,720 HIGHER COST OR FEWER CHEMICALS 3334 02:19:02,720 --> 02:19:05,800 TESTED FOR EXPERIMENT. 3335 02:19:05,800 --> 02:19:09,040 THAT'S REALLY GETTING INTO 3336 02:19:09,040 --> 02:19:09,840 CONSENSUS PROCESS DISCUSSING 3337 02:19:09,840 --> 02:19:10,920 WITH COLLEAGUES ABOUT IS IT 3338 02:19:10,920 --> 02:19:13,240 WORTH IT, IN THIS CASE FOR THIS 3339 02:19:13,240 --> 02:19:14,760 CONTEXT AND USE. 3340 02:19:14,760 --> 02:19:17,840 SOMETIMES IT MAY BE, SOMETIMES 3341 02:19:17,840 --> 02:19:22,720 OTHER FACTORS MAY BE 3342 02:19:22,720 --> 02:19:23,520 PRIORITIZED. 3343 02:19:23,520 --> 02:19:26,120 NOW, BRIEFLY A CASE STUDY 3344 02:19:26,120 --> 02:19:30,080 APPLYING THIS FRAMEWORK TO AN 3345 02:19:30,080 --> 02:19:30,320 ASSAY. 3346 02:19:30,320 --> 02:19:34,040 IT WAS FROM AN INTERAGENCY 3347 02:19:34,040 --> 02:19:34,880 AGREEMENT WITH OURSELVES AND 3348 02:19:34,880 --> 02:19:36,960 NATIONAL INSTITUTE OF DENTAL AND 3349 02:19:36,960 --> 02:19:37,840 CRANIOFACIAL RESEARCH, LAST FEW 3350 02:19:37,840 --> 02:19:38,680 YEARS. 3351 02:19:38,680 --> 02:19:42,680 WE HAD A WORKSHOP BACK IN -- A 3352 02:19:42,680 --> 02:19:45,720 NUMBER IN 2021 WITH FEEDBACK IT 3353 02:19:45,720 --> 02:19:48,560 COULD BE INTERESTING TO TAKE AN 3354 02:19:48,560 --> 02:19:51,760 ASSAY THAT LOOKS AT TISSUE AND 3355 02:19:51,760 --> 02:19:56,760 OCCLUSAL TISSUE THROUGH THE 3356 02:19:56,760 --> 02:19:57,400 FRAMEWORK. 3357 02:19:57,400 --> 02:20:00,080 A CASE STUDY, ORAL CONSTRUCTS, 3358 02:20:00,080 --> 02:20:03,160 HOW THIS EXPERIMENT WORKS, YOU 3359 02:20:03,160 --> 02:20:04,440 WILL ADD SOMETHING DIRECTLY ON 3360 02:20:04,440 --> 02:20:06,400 THE TISSUE, AND LOOK AT THE 3361 02:20:06,400 --> 02:20:09,600 CHANGE IN VIABILITY SUCH AS WITH 3362 02:20:09,600 --> 02:20:12,840 MPT ASSAY. 3363 02:20:12,840 --> 02:20:14,520 YOU MAY KNOW THERE ARE 3364 02:20:14,520 --> 02:20:17,480 IRRITATION ASSAYS THAT HAVE BEEN 3365 02:20:17,480 --> 02:20:19,760 APPROVED THROUGH ISO FOR 3366 02:20:19,760 --> 02:20:22,400 EPIDERMAL TISSUE BUT NOT DONE 3367 02:20:22,400 --> 02:20:23,720 FOR FOR ORAL MUCOSAL TISSUE. 3368 02:20:23,720 --> 02:20:25,480 ONE OF THE THINGS THAT'S REALLY 3369 02:20:25,480 --> 02:20:28,720 VALUABLE ABOUT THESE TISSUES, 3370 02:20:28,720 --> 02:20:33,000 YOU CAN TEST POLAR AND NON-POLAR 3371 02:20:33,000 --> 02:20:34,440 SOLVENTS, UNLIKE ADHERENT 3372 02:20:34,440 --> 02:20:41,320 ASSAYS, SOME OTHER NAMs WORK, 3373 02:20:41,320 --> 02:20:45,920 IF YOU ADD SOMETHING, IT'S A 3374 02:20:45,920 --> 02:20:48,080 CHALLENGE FOR NON-POLAR 3375 02:20:48,080 --> 02:20:48,360 SOLVENTS. 3376 02:20:48,360 --> 02:20:51,280 THAT'S A DISTINCT POSSIBILITY. 3377 02:20:51,280 --> 02:20:55,080 ANOTHER THING THAT'S REALLY 3378 02:20:55,080 --> 02:20:56,440 INTERESTING ABOUT THIS PROJECT 3379 02:20:56,440 --> 02:20:57,640 IS WE'RE REALLY LIMITED IN TERMS 3380 02:20:57,640 --> 02:21:00,480 OF THE NUMBER OF TISSUES THAT WE 3381 02:21:00,480 --> 02:21:00,800 HAVE. 3382 02:21:00,800 --> 02:21:03,120 YOU CAN MAKE AN ORDER AND GET 3383 02:21:03,120 --> 02:21:05,400 ONCE EVERY TWO WEEKS OR SO. 3384 02:21:05,400 --> 02:21:09,160 AND YOU CAN ORDER THEM IN 3385 02:21:09,160 --> 02:21:11,280 ALIQUOTS OF 24 TISSUES, AND 3386 02:21:11,280 --> 02:21:16,680 THOSE COST AROUND $2,000 OR SO. 3387 02:21:16,680 --> 02:21:19,560 AND SO YOU REALLY THOUGHT 3388 02:21:19,560 --> 02:21:21,200 CAREFULLY ABOUT EVERY SINGLE 3389 02:21:21,200 --> 02:21:23,040 CONSTRUCT AND TRADEOFFS OF 3390 02:21:23,040 --> 02:21:25,280 DIFFERENT CONTROLS AND SO ON. 3391 02:21:25,280 --> 02:21:26,960 BECAUSE WE'RE REALLY, YOU KNOW, 3392 02:21:26,960 --> 02:21:31,880 IT'S VERY DIFFERENT FROM HAVING 3393 02:21:31,880 --> 02:21:32,560 96 WELLS. 3394 02:21:32,560 --> 02:21:34,840 WITH 24 ONLY YOU NEEDED TO THINK 3395 02:21:34,840 --> 02:21:36,520 JUDICIOUSLY ABOUT HOW WE WANTED 3396 02:21:36,520 --> 02:21:37,280 TO USE THEM. 3397 02:21:37,280 --> 02:21:43,800 SO THIS IS AN EXAMPLE OF CAUSE 3398 02:21:43,800 --> 02:21:47,640 AND EFFECT FOR MTT ASSAY HOW 3399 02:21:47,640 --> 02:21:52,680 WE'RE ASSESSING VIABILITY CHANGE 3400 02:21:52,680 --> 02:21:54,120 AFTER RESULT OF RELEVANT 3401 02:21:54,120 --> 02:21:55,520 MATERIALS, SOME ARE SIMILAR TO 3402 02:21:55,520 --> 02:21:58,480 CAUSE AND EFFECT ITEMS IN THE 3403 02:21:58,480 --> 02:22:02,880 PAST SUCH AS PLATE READER, AS 3404 02:22:02,880 --> 02:22:05,480 YOU KNOW FROM PREVIOUS 3405 02:22:05,480 --> 02:22:06,920 PRESENTATIONS, PAYING A LOT OF 3406 02:22:06,920 --> 02:22:10,000 ATTENTION, WE'VE BEEN LOOKING AT 3407 02:22:10,000 --> 02:22:11,200 THINGS LIKE, WELL, FOR EVERY 3408 02:22:11,200 --> 02:22:12,520 CONSTRUCT HOW MANY WELLS SHOULD 3409 02:22:12,520 --> 02:22:16,360 WE DO IN OUR FINAL 96 WELL PLATE 3410 02:22:16,360 --> 02:22:17,680 FROM THE PLATE READER, HOW MANY 3411 02:22:17,680 --> 02:22:20,160 TIMES UP AND DOWN BEFORE WE'RE 3412 02:22:20,160 --> 02:22:20,960 TRANSFERRING OVER, COULD THERE 3413 02:22:20,960 --> 02:22:23,000 BE CHANGES WITH TIME FROM THE 3414 02:22:23,000 --> 02:22:24,560 FIRST TO THE LAST SAMPLE THAT 3415 02:22:24,560 --> 02:22:28,600 WE'RE DOING THAT COULD THEN LEAD 3416 02:22:28,600 --> 02:22:34,400 TO UNEXPECTED BIASES IN RESULTS 3417 02:22:34,400 --> 02:22:37,800 AND SO FORTH. 3418 02:22:37,800 --> 02:22:40,080 PIPETTING, INS AND OUTS. 3419 02:22:40,080 --> 02:22:40,960 POSITIVE CONTROL IS AN 3420 02:22:40,960 --> 02:22:43,160 INTERESTING DISCUSSION WITH THIS 3421 02:22:43,160 --> 02:22:44,240 ASSAY BECAUSE WHAT'S SUGGESTED 3422 02:22:44,240 --> 02:22:47,240 TO LOOK AT A TIME SERIES, NOT 3423 02:22:47,240 --> 02:22:49,840 CONCENTRATION SERIES IN TERMS OF 3424 02:22:49,840 --> 02:22:53,960 CONTROLS, AND ALSO INTEG -- 3425 02:22:53,960 --> 02:22:56,240 INTERROGATE TO HAVE THE 3426 02:22:56,240 --> 02:22:58,160 CONFIDENCE WE WANT, 24 PER 3427 02:22:58,160 --> 02:23:02,560 EXPERIMENT, ARE YOU TO CHOOSE 3428 02:23:02,560 --> 02:23:03,040 CAREFULLY. 3429 02:23:03,040 --> 02:23:05,040 THERE'S MORE NUANCE AND DETAILS 3430 02:23:05,040 --> 02:23:08,080 I'LL GET INTO, SHOWING A LITTLE 3431 02:23:08,080 --> 02:23:09,560 BIT OF DATA, NEGATIVE CONTROLS, 3432 02:23:09,560 --> 02:23:12,680 TO GIVE A FLAVOR OF WHAT WE'VE 3433 02:23:12,680 --> 02:23:15,240 BEEN UP TO. 3434 02:23:15,240 --> 02:23:17,320 LET'S GO THERE NOW. 3435 02:23:17,320 --> 02:23:20,920 SO ONE OF THE THINGS WE'RE 3436 02:23:20,920 --> 02:23:22,880 LOOKING TO, A NON-DESTRUCTIVE 3437 02:23:22,880 --> 02:23:24,440 APPROACH TO LET US KNOW ARE 3438 02:23:24,440 --> 02:23:26,160 THINGS FUNCTIONING AS WE THINK 3439 02:23:26,160 --> 02:23:28,720 THEY ARE, WHAT WE'RE GETTING 3440 02:23:28,720 --> 02:23:29,320 FROM OUR SUPPLIER. 3441 02:23:29,320 --> 02:23:32,320 AND SO ON THE LEFT YOU CAN SEE 3442 02:23:32,320 --> 02:23:38,000 THE BLANKET INSERTS, WHEN WE USE 3443 02:23:38,000 --> 02:23:40,840 CHAMBER BASED SYSTEM, CONSISTENT 3444 02:23:40,840 --> 02:23:46,440 RESULTS, SO THAT WAS GOOD. 3445 02:23:46,440 --> 02:23:47,960 THERE'S VARIABILITY IN TISSUES, 3446 02:23:47,960 --> 02:23:49,840 BY FACTOR OF TWO ACROSS 3447 02:23:49,840 --> 02:23:50,160 EXPERIMENTS. 3448 02:23:50,160 --> 02:23:54,320 WE DIDN'T FIND THESE IMPACTED 3449 02:23:54,320 --> 02:23:59,520 OUR MTT RESULTS, CLEAR IT 3450 02:23:59,520 --> 02:24:02,000 DOESN'T MEAN, 800 OR 1800. 3451 02:24:02,000 --> 02:24:05,280 THERE WAS YOU'LL NOTICE ONE IN 3452 02:24:05,280 --> 02:24:09,880 BLUE, ESSENTIALLY ZERO FOR OUR 3453 02:24:09,880 --> 02:24:11,520 TIER MEASUREMENT INDICATING 3454 02:24:11,520 --> 02:24:13,400 FUNCTION, RAISING A RED FLAG IN 3455 02:24:13,400 --> 02:24:16,560 TERMS OF WHAT'S GOING ON HERE. 3456 02:24:16,560 --> 02:24:19,280 CURIOUS TO SEE HOW SAME TISSUES 3457 02:24:19,280 --> 02:24:23,880 IN TERMS OF NEGATIVE CONTROL FOR 3458 02:24:23,880 --> 02:24:28,360 MTT ASSAY. 3459 02:24:28,360 --> 02:24:32,240 AND YOU CAN SEE SAME DAY WE HAD 3460 02:24:32,240 --> 02:24:40,120 ALSO VERY LOW MTT RESULTS, ONE 3461 02:24:40,120 --> 02:24:42,280 WITH LOW TEER VALUE, A HEADS UP 3462 02:24:42,280 --> 02:24:44,600 SOMETHING'S NOT LOOKING QUITE 3463 02:24:44,600 --> 02:24:44,840 RIGHT. 3464 02:24:44,840 --> 02:24:51,160 WE'RE NOT SURE WHAT HAPPENED, 3465 02:24:51,160 --> 02:24:52,280 PRESUMABLY A SHIPPING ISSUE OR 3466 02:24:52,280 --> 02:24:55,080 LEFT ON A HANGER TOO LONG, 3467 02:24:55,080 --> 02:25:01,240 SOMETHING UNCLEAR HAPPENED 3468 02:25:01,240 --> 02:25:01,720 THERE. 3469 02:25:01,720 --> 02:25:04,640 MTT ASSAY, SCRATCH YOUR HEADS, 3470 02:25:04,640 --> 02:25:06,520 IS MTT GONE BAD, DID WE FORGET 3471 02:25:06,520 --> 02:25:08,040 TO ADD IT? 3472 02:25:08,040 --> 02:25:08,920 WHAT WAS HAPPENING? 3473 02:25:08,920 --> 02:25:12,080 SINCE WE HAD THE TEER TO BACK IT 3474 02:25:12,080 --> 02:25:16,800 UP IT GAVE US CONFIDENCE IT WAS 3475 02:25:16,800 --> 02:25:18,320 SOMETHING IN THE CONSTRUCTS, 3476 02:25:18,320 --> 02:25:19,760 SOMETHING WASN'T QUITE RIGHT. 3477 02:25:19,760 --> 02:25:25,680 YOU CAN SEE THERE'S A REASONABLE 3478 02:25:25,680 --> 02:25:28,160 RANGE FOR NEGATIVE CONTROL FOR 3479 02:25:28,160 --> 02:25:29,920 MTT ASSAY, ALSO GOT GOOD 3480 02:25:29,920 --> 02:25:31,040 COEFFICIENT OF VARIATION WHERE 3481 02:25:31,040 --> 02:25:34,880 TYPICALLY SOMETIMES IT COULD BE 3482 02:25:34,880 --> 02:25:37,720 AS LOW AS 2%, OR LESS THAN 8% IN 3483 02:25:37,720 --> 02:25:39,680 TERMS OF JUST VARIABILITY FOR 3484 02:25:39,680 --> 02:25:41,440 OUR NEGATIVE CONTROLS. 3485 02:25:41,440 --> 02:25:47,800 SO THIS IS -- THINGS ARE LOOKING 3486 02:25:47,800 --> 02:25:48,080 CONSISTENT. 3487 02:25:48,080 --> 02:25:48,800 VARIABILITY, TISSUE VARIABILITY, 3488 02:25:48,800 --> 02:25:56,000 ALSO FROM JUST THE PIPETTING 3489 02:25:56,000 --> 02:26:01,240 STEPS THEMSELVES. 3490 02:26:01,240 --> 02:26:02,480 NEXT SLIDE. 3491 02:26:02,480 --> 02:26:05,840 THIS IS A TECHNICAL COMPONENT, 3492 02:26:05,840 --> 02:26:08,680 HOW CAN WE LOOK AT THE 3493 02:26:08,680 --> 02:26:10,560 BIOLOGICAL RELEVANCE, TALKING 3494 02:26:10,560 --> 02:26:14,560 ABOUT HOW THAT'S A STRATEGIC 3495 02:26:14,560 --> 02:26:15,880 QUESTION BECAUSE YOU COULD HAVE 3496 02:26:15,880 --> 02:26:18,400 A NAM GIVING THE SAME RESULT, 3497 02:26:18,400 --> 02:26:19,840 BUT LAST THIS COMPARED TO THE 3498 02:26:19,840 --> 02:26:22,800 PAST WHICH OFTEN FOR MANY CASES 3499 02:26:22,800 --> 02:26:27,640 IS INDEED EXPERIMENTS, HOW CAN 3500 02:26:27,640 --> 02:26:30,880 WE RELATE TO TWO, SOMETHING 3501 02:26:30,880 --> 02:26:32,240 WE'RE CONSIDERING TESTING A 3502 02:26:32,240 --> 02:26:34,080 RANGE IN THIS ASSAY. 3503 02:26:34,080 --> 02:26:37,760 SO, AS I WAS SAYING, THIS ASSAY 3504 02:26:37,760 --> 02:26:39,560 IS UNIQUE. 3505 02:26:39,560 --> 02:26:44,560 THERE'S SOME -- LIMITED NUMBER 3506 02:26:44,560 --> 02:26:46,360 OF SAMPLES AND FREQUENCY, WE 3507 02:26:46,360 --> 02:26:47,440 CAREFULLY THINK ABOUT USING 3508 02:26:47,440 --> 02:26:52,880 EVERY LAST CONSTRUCT ABOUT 3509 02:26:52,880 --> 02:26:53,320 THOSE. 3510 02:26:53,320 --> 02:26:56,720 APPLIED A LOT THE OF CONCEPTUAL 3511 02:26:56,720 --> 02:27:00,120 TOOLS TOWNS ASSAY. 3512 02:27:00,120 --> 02:27:01,560 ROBUSTNESS TESTING, WRAP THIS UP 3513 02:27:01,560 --> 02:27:05,280 AND WRITE A PAPER. 3514 02:27:05,280 --> 02:27:06,480 WE'VE LOOKED AT DIFFERENT 3515 02:27:06,480 --> 02:27:06,680 THINGS. 3516 02:27:06,680 --> 02:27:08,120 DIVING MORE INTO THE TOPIC, 3517 02:27:08,120 --> 02:27:10,120 PLEASE REACH OUT TO ME, I'M 3518 02:27:10,120 --> 02:27:13,480 HAPPY TO HAVE A DISCUSSION AND 3519 02:27:13,480 --> 02:27:16,840 SHOW YOU SOME MORE OF THE 3520 02:27:16,840 --> 02:27:19,280 NUANCES HERE. 3521 02:27:19,280 --> 02:27:21,560 MADE A LOT OF CONTROL CHARTS, 3522 02:27:21,560 --> 02:27:24,000 POSITIVE CONTROLS, NEGATIVE 3523 02:27:24,000 --> 02:27:26,280 CONTROLS, TESTED MULTIPLE LEVEL 3524 02:27:26,280 --> 02:27:26,760 COMPOUNDS. 3525 02:27:26,760 --> 02:27:28,360 ONE THING THAT'S BECOME 3526 02:27:28,360 --> 02:27:29,440 INTERESTING BASED ON 3527 02:27:29,440 --> 02:27:30,520 UNCERTAINTIES OF NEGATIVE 3528 02:27:30,520 --> 02:27:32,520 CONTROL, UNCERTAINTY OF TEST 3529 02:27:32,520 --> 02:27:36,320 COMPOUND, HOW DO YOU SET A 3530 02:27:36,320 --> 02:27:41,560 THRESHOLD FOR POSITIVE OR 3531 02:27:41,560 --> 02:27:42,760 NEGATIVE USING STATISTICAL 3532 02:27:42,760 --> 02:27:48,360 MODEL, AND IT'S INTERESTING THAT 3533 02:27:48,360 --> 02:27:50,360 HOPEFULLY WE COULD THEN WITH 3534 02:27:50,360 --> 02:27:51,760 TRADITIONAL ANIMAL DATA LOOKING 3535 02:27:51,760 --> 02:27:53,520 AT IRRITATION BECAUSE IT'S 3536 02:27:53,520 --> 02:27:59,120 ALMOST LIKE THERE'S UNCERTAINTY 3537 02:27:59,120 --> 02:28:07,440 AND SOME TYPE SCALE WITH IN 3538 02:28:07,440 --> 02:28:10,160 VITRO AND IN VIVO DATA, HOW CAN 3539 02:28:10,160 --> 02:28:11,680 THEY LINK UP WITH OUR 3540 02:28:11,680 --> 02:28:13,680 SENSITIVITY OF ASSAYS IS 3541 02:28:13,680 --> 02:28:16,600 HOPEFULLY GIVING SOMETHING 3542 02:28:16,600 --> 02:28:18,160 SIMILAR TO WHAT A TRADITIONAL 3543 02:28:18,160 --> 02:28:18,920 ASSAY WOULD PROVIDE. 3544 02:28:18,920 --> 02:28:20,120 THAT'S ALL I HAVE. 3545 02:28:20,120 --> 02:28:23,640 I'M HAPPY TO HAVE ANY QUESTIONS. 3546 02:28:23,640 --> 02:28:31,800 [APPLAUSE] 3547 02:28:31,800 --> 02:28:33,360 >> THANKS VERY MUCH, ELIJAH. 3548 02:28:33,360 --> 02:28:35,360 DO WE HAVE ANY QUESTIONS IN THE 3549 02:28:35,360 --> 02:28:38,040 ROOM FOR ELIJAH? 3550 02:28:38,040 --> 02:28:42,560 3551 02:28:42,560 --> 02:28:43,200 OKAY. 3552 02:28:43,200 --> 02:28:43,400 GREAT. 3553 02:28:43,400 --> 02:28:43,960 THANK YOU. 3554 02:28:43,960 --> 02:28:47,240 SO THEN I THINK WHAT WE'LL DO IS 3555 02:28:47,240 --> 02:28:48,800 WE'RE GOING TO GO TO THE 3556 02:28:48,800 --> 02:28:52,880 QUESTIONS THAT HAVE COME IN 3557 02:28:52,880 --> 02:28:55,720 ONLINE. 3558 02:28:55,720 --> 02:29:02,360 THERE WE GO. 3559 02:29:02,360 --> 02:29:02,560 GREAT. 3560 02:29:02,560 --> 02:29:05,120 WELL DONE. 3561 02:29:05,120 --> 02:29:08,800 LET ME GO BACK TO THIS SLIDE. 3562 02:29:08,800 --> 02:29:11,200 DAVE, DO YOU WANT TO -- 3563 02:29:11,200 --> 02:29:11,440 >>SURE. 3564 02:29:11,440 --> 02:29:13,840 >>READ OUT THE QUESTIONS THAT 3565 02:29:13,840 --> 02:29:15,440 CAME IN ONLINE PLEASE. 3566 02:29:15,440 --> 02:29:16,920 >>FIRST IS FOR SUZIE 3567 02:29:16,920 --> 02:29:18,880 FITZPATRICK WHO HAD TO GO TO AN 3568 02:29:18,880 --> 02:29:21,840 ON-SITE MEETING AT THE FDA THIS 3569 02:29:21,840 --> 02:29:22,480 AFTERNOON. 3570 02:29:22,480 --> 02:29:24,920 BUT THE QUESTION WAS, THIS COMES 3571 02:29:24,920 --> 02:29:26,000 FROM SHERMAN McFARLAND, 3572 02:29:26,000 --> 02:29:28,400 POSTDOC AT THE TOXICOLOGY POLICY 3573 02:29:28,400 --> 02:29:30,720 GROUP AT JOHNS HOPKINS BLOOMBERG 3574 02:29:30,720 --> 02:29:32,360 SCHOOL OF PUBLIC HEALTH. 3575 02:29:32,360 --> 02:29:35,520 SHERMAN ASKS, I WANTED TO 3576 02:29:35,520 --> 02:29:38,400 CONFIRM WHETHER SUZANNE 3577 02:29:38,400 --> 02:29:43,640 FITZPATRICK SAID THE FDA HAS NOT 3578 02:29:43,640 --> 02:29:45,040 DONE ANIMAL TEST SIX 2016. 3579 02:29:45,040 --> 02:29:48,000 TO CLARIFY I BELIEVE IT WAS DOG 3580 02:29:48,000 --> 02:29:50,200 SINCE 2018 BUT WE CAN SHARE AND 3581 02:29:50,200 --> 02:29:52,400 CONFIRM AS ACCURATE. 3582 02:29:52,400 --> 02:29:56,200 ALSO HE ASKS FOR JESSICA LEET, 3583 02:29:56,200 --> 02:29:57,920 HOW GILL SAMPLING IS PERFORMED 3584 02:29:57,920 --> 02:30:02,600 AND WHAT IS GILL SAMPLING? 3585 02:30:02,600 --> 02:30:03,640 >> THANKS. 3586 02:30:03,640 --> 02:30:06,720 THEY JUST TAKE A SMALL CLIP OF 3587 02:30:06,720 --> 02:30:09,320 THE GILL FROM THE FISH, IT'S 3588 02:30:09,320 --> 02:30:12,080 NON-LETHAL, AND THEY CAN HEAL 3589 02:30:12,080 --> 02:30:12,520 FROM THAT. 3590 02:30:12,520 --> 02:30:15,280 SO IT'S, YOU KNOW, A MINIMALLY 3591 02:30:15,280 --> 02:30:16,000 INVASIVE SAMPLING TECHNIQUE. 3592 02:30:16,000 --> 02:30:18,000 WHAT THEY ARE TRYING TO GROUND 3593 02:30:18,000 --> 02:30:23,280 TRUTH RIGHT NOW IS USING THAT TO 3594 02:30:23,280 --> 02:30:24,840 TRACK THE VIRAL PATHOGENS AND 3595 02:30:24,840 --> 02:30:29,680 THEIR MOVEMENT. 3596 02:30:29,680 --> 02:30:31,640 >> I HAVE A FOLLOW-UP QUESTION 3597 02:30:31,640 --> 02:30:32,400 ON THAT. 3598 02:30:32,400 --> 02:30:34,920 SO IT'S CURRENTLY BEING USED TO 3599 02:30:34,920 --> 02:30:37,440 TRACK PATHOGENS, BUT IS THERE 3600 02:30:37,440 --> 02:30:43,360 POTENTIAL TO USE IT AS A 3601 02:30:43,360 --> 02:30:43,920 BIOMONITORING OPTION? 3602 02:30:43,920 --> 02:30:46,000 >>YEAH, I'M NOT SURE WITH THAT 3603 02:30:46,000 --> 02:30:48,400 SAMPLING IF YOU COULD GET GOOD 3604 02:30:48,400 --> 02:30:50,240 LIKE HISTOLOGY, FOR EXAMPLE, 3605 02:30:50,240 --> 02:30:53,120 FROM IT BUT DEFINITELY ANY 3606 02:30:53,120 --> 02:30:55,680 MOLECULAR ENDPOINTS, SO THEY ARE 3607 02:30:55,680 --> 02:30:58,880 DOING SEQUENCING FROM THOSE 3608 02:30:58,880 --> 02:31:00,400 SAMPLES, AND SO POTENTIALLY 3609 02:31:00,400 --> 02:31:01,640 COULD BE MONITORED, YOU KNOW, 3610 02:31:01,640 --> 02:31:05,120 OTHER THINGS AS WELL. 3611 02:31:05,120 --> 02:31:07,680 >> OKAY. 3612 02:31:07,680 --> 02:31:07,920 THANKS. 3613 02:31:07,920 --> 02:31:09,880 >> NEXT QUESTION IS GENERAL 3614 02:31:09,880 --> 02:31:11,520 QUESTION FROM BRANDON WHITE. 3615 02:31:11,520 --> 02:31:12,800 NEW TRAINEE IN TOXICOLOGY, IS 3616 02:31:12,800 --> 02:31:14,800 THERE A CENTRAL PLACE ALL YOUR 3617 02:31:14,800 --> 02:31:16,640 ORGANIZATIONS LOOK TO FOR 3618 02:31:16,640 --> 02:31:17,760 GUIDANCE ON THE SCIENCE RESULTS 3619 02:31:17,760 --> 02:31:18,600 OF NAMs? 3620 02:31:18,600 --> 02:31:21,480 IS THERE A SINGLE PLACE TO GO 3621 02:31:21,480 --> 02:31:24,440 TO, TO REVIEW THE AOPs AND 3622 02:31:24,440 --> 02:31:26,960 NAMs BEING CONSIDERED FOR 3623 02:31:26,960 --> 02:31:28,480 REGULATORY USE. 3624 02:31:28,480 --> 02:31:29,240 NICOLE, YOU CAN START. 3625 02:31:29,240 --> 02:31:31,240 >> YEAH, I CAN PROVIDE A BIASED 3626 02:31:31,240 --> 02:31:35,600 ANSWER TO THAT WHICH IS THAT 3627 02:31:35,600 --> 02:31:38,520 NICEATM WEBSITE IS AN EXCELLENT 3628 02:31:38,520 --> 02:31:41,720 RESOURCE, AT LEAST AS A STARTING 3629 02:31:41,720 --> 02:31:42,520 POINT. 3630 02:31:42,520 --> 02:31:47,160 WE HAVE A PAGE ON THE WEBSITE 3631 02:31:47,160 --> 02:31:50,200 THAT LISTS THE CURRENT 3632 02:31:50,200 --> 02:31:52,280 REGULATORY ACCEPTED ALTERNATIVE 3633 02:31:52,280 --> 02:31:54,680 METHODS, LOTS OF PAGES WITHIN 3634 02:31:54,680 --> 02:31:57,520 THAT SITE FOR PROJECTS UNDER 3635 02:31:57,520 --> 02:32:00,640 DEVELOPMENT, LINKS TO DIFFERENT 3636 02:32:00,640 --> 02:32:03,680 OTHER EXTERNAL RESOURCES, AS FAR 3637 02:32:03,680 --> 02:32:10,920 AS AOPs THE OECD WEBSITE HAS A 3638 02:32:10,920 --> 02:32:13,840 WEALTH OF INFORMATION, AND ALSO 3639 02:32:13,840 --> 02:32:18,120 AOP KNOWLEDGE BASE AND AOP WIKI 3640 02:32:18,120 --> 02:32:21,400 BASED ON SEARCHABLE THINGS LIKE 3641 02:32:21,400 --> 02:32:23,160 MOLECULAR ENDPOINT, MOLECULAR 3642 02:32:23,160 --> 02:32:24,440 TARGET, ADVERSE EFFECT. 3643 02:32:24,440 --> 02:32:26,320 MY ANSWER IS GOING TO BE START 3644 02:32:26,320 --> 02:32:30,040 WITH THE NICEATM WEBSITE AND 3645 02:32:30,040 --> 02:32:34,200 THEN MAYBE NAVIGATE OUT FROM 3646 02:32:34,200 --> 02:32:35,320 THERE. 3647 02:32:35,320 --> 02:32:35,760 >> OKAY. 3648 02:32:35,760 --> 02:32:38,280 >> ONE OTHER THING I'LL MENTION 3649 02:32:38,280 --> 02:32:42,960 IS THAT THE -- OUR EUROPEAN 3650 02:32:42,960 --> 02:32:43,880 PARTNERS, JOINT RESEARCH CENTER 3651 02:32:43,880 --> 02:32:44,880 HAS A GREAT WEBSITE. 3652 02:32:44,880 --> 02:32:46,720 AS PART OF THEIR WEBSITE THEY 3653 02:32:46,720 --> 02:32:51,280 HAVE WHAT'S CALLED THE T.S.A.R, 3654 02:32:51,280 --> 02:32:56,120 TRACKING SYSTEM ON ALTERNATIVE 3655 02:32:56,120 --> 02:32:57,000 THOUGHTS AND REGULATORY 3656 02:32:57,000 --> 02:32:57,600 ACCEPTANCE MAYBE, I DON'T KNOW 3657 02:32:57,600 --> 02:32:59,320 WHAT THE R STANDS FOR. 3658 02:32:59,320 --> 02:33:02,160 IT'S A DATABASE OF ALTERNATIVE 3659 02:33:02,160 --> 02:33:09,040 METHODS, WHERE THEY ARE IN THE 3660 02:33:09,040 --> 02:33:10,120 DEVELOPMENT, VALIDATION AND 3661 02:33:10,120 --> 02:33:11,080 REGULATORY INFORMATION PROCESS. 3662 02:33:11,080 --> 02:33:13,280 >> I'M ASSUMING THE NEXT IS FOR 3663 02:33:13,280 --> 02:33:14,120 CHARLES KOVATCH. 3664 02:33:14,120 --> 02:33:18,320 CAN YOU HEAR? 3665 02:33:18,320 --> 02:33:20,000 ARE YOU AUDIBLE? 3666 02:33:20,000 --> 02:33:22,080 >> YES. 3667 02:33:22,080 --> 02:33:22,320 >> GREAT. 3668 02:33:22,320 --> 02:33:23,360 FROM GINA LINTO. 3669 02:33:23,360 --> 02:33:27,840 HOW DOES ONE NOMINATE A PERSON 3670 02:33:27,840 --> 02:33:28,520 TO AN EXPERT GROUP? 3671 02:33:28,520 --> 02:33:31,160 >> THANKS FOR THE QUESTION. 3672 02:33:31,160 --> 02:33:34,200 WHAT'S ALSO GREAT ABOUT THAT 3673 02:33:34,200 --> 02:33:36,400 QUESTION IS IT'S ALWAYS WELCOME 3674 02:33:36,400 --> 02:33:38,160 TO HAVE PEOPLE INTERESTED IN 3675 02:33:38,160 --> 02:33:41,520 SERVING ON EXPERT GROUPS, 3676 02:33:41,520 --> 02:33:46,320 OFTENTIMES THEY CAN BE WITH ARM 3677 02:33:46,320 --> 02:33:49,600 TWISTING AND CAJOLING, RIGHT, 3678 02:33:49,600 --> 02:33:52,160 CAN BE A LONG TIME. 3679 02:33:52,160 --> 02:33:54,800 EXPERT GROUPS CAN BE -- 3680 02:33:54,800 --> 02:33:58,080 REPRESENTATIVES ON EXPERT GROUPS 3681 02:33:58,080 --> 02:34:00,280 FROM GOVERNMENT, FROM INDUSTRY, 3682 02:34:00,280 --> 02:34:01,560 DIFFERENT ORGANIZATIONS, 3683 02:34:01,560 --> 02:34:01,840 ACADEMIA. 3684 02:34:01,840 --> 02:34:07,600 SO LOTS OF FOLKS SERVE ON EXPERT 3685 02:34:07,600 --> 02:34:07,840 GROUPS. 3686 02:34:07,840 --> 02:34:08,680 I THINK SPECIFICALLY FOR 3687 02:34:08,680 --> 02:34:11,520 SOMEBODY WHO IS FROM INDUSTRY I 3688 02:34:11,520 --> 02:34:14,840 THINK THE BUSINESS COMMUNITY, 3689 02:34:14,840 --> 02:34:19,200 SOMETIMES GOING THROUGH BEAC, 3690 02:34:19,200 --> 02:34:19,800 THE BUSINESS COMMUNITY'S OECD, 3691 02:34:19,800 --> 02:34:24,680 THEY HAVE A LOT OF 3692 02:34:24,680 --> 02:34:25,280 REPRESENTATIVES, THE AMERICAN 3693 02:34:25,280 --> 02:34:32,880 COUNCIL IN THE U.S. IS ONE GROUP 3694 02:34:32,880 --> 02:34:38,800 IS ACTIVE FOR BEAC, ALSO THROUGH 3695 02:34:38,800 --> 02:34:43,840 COUNCIL ON ANIMAL PROTECTION IN 3696 02:34:43,840 --> 02:34:46,440 OECD, REPRESENTS A NUMBER OF 3697 02:34:46,440 --> 02:34:47,320 PEOPLE IN DIFFERENT 3698 02:34:47,320 --> 02:34:48,840 ORGANIZATIONS THAT PARTICIPATE 3699 02:34:48,840 --> 02:34:50,920 ON EXPERT GROUPS. 3700 02:34:50,920 --> 02:34:53,600 SO TWO MECHANISMS FOR 3701 02:34:53,600 --> 02:34:55,280 NON-FEDERAL FOLKS. 3702 02:34:55,280 --> 02:35:01,320 I THINK TO GET ON AN EXPERT 3703 02:35:01,320 --> 02:35:03,400 GROUP, I WOULD SUGGEST YOU REACH 3704 02:35:03,400 --> 02:35:03,760 OUT DIRECTLY. 3705 02:35:03,760 --> 02:35:07,760 SOMETIMES THERE ARE REQUESTS FOR 3706 02:35:07,760 --> 02:35:10,000 INDEPENDENT EXPERT GROUP 3707 02:35:10,000 --> 02:35:14,240 MEMBERS, AND OTHER TIMES THERE 3708 02:35:14,240 --> 02:35:16,120 ARE SPECIFIC FEDERAL REQUESTS, 3709 02:35:16,120 --> 02:35:18,440 LIKE DOES THIS PERSON REPRESENT 3710 02:35:18,440 --> 02:35:19,440 THE UNITED STATES GOVERNMENT, SO 3711 02:35:19,440 --> 02:35:22,440 I THINK IF YOU HAVE A QUESTION, 3712 02:35:22,440 --> 02:35:23,080 SOMETHING SPECIFICALLY, REACH 3713 02:35:23,080 --> 02:35:25,160 OUT TO ME AND I CAN HELP STEER 3714 02:35:25,160 --> 02:35:27,760 YOU IN THE RIGHT DIRECTION. 3715 02:35:27,760 --> 02:35:28,720 >> THANK YOU, CHARLES. 3716 02:35:28,720 --> 02:35:29,480 >> GREAT. 3717 02:35:29,480 --> 02:35:30,920 KEEP YOURSELF UNMUTED BECAUSE WE 3718 02:35:30,920 --> 02:35:34,160 HAVE ONE OTHER QUESTION FROM AMY 3719 02:35:34,160 --> 02:35:35,240 KYLE FROM UC-BERKELEY. 3720 02:35:35,240 --> 02:35:39,760 WHAT KINDS OF POLICIES OR 3721 02:35:39,760 --> 02:35:44,320 PROCESSES DOES OECD USE TO GUARD 3722 02:35:44,320 --> 02:35:47,200 AGAINST BIAS INFLUENCING REVIEWS 3723 02:35:47,200 --> 02:35:51,240 AND CONSULTATIONS, IS THERE 3724 02:35:51,240 --> 02:35:53,240 INTERNATIONAL STANDARD THAT THEY 3725 02:35:53,240 --> 02:35:58,560 DON'T REFLECT PERSONAL OR 3726 02:35:58,560 --> 02:35:59,160 INSTITUTIONAL INTEREST? 3727 02:35:59,160 --> 02:36:02,880 >> IF I REMEMBER THE FIRST 3728 02:36:02,880 --> 02:36:05,040 HALF, READ IT AGAIN, GUARDING 3729 02:36:05,040 --> 02:36:06,480 AGAINST BIAS? 3730 02:36:06,480 --> 02:36:07,200 >> SURE. 3731 02:36:07,200 --> 02:36:09,080 GUARDING AGAINST BIAS OR 3732 02:36:09,080 --> 02:36:12,360 ECONOMIC INTEREST INFLUENCING 3733 02:36:12,360 --> 02:36:16,960 REVIEWS AND CONSULTATIONS OECD 3734 02:36:16,960 --> 02:36:17,200 SPONSORS. 3735 02:36:17,200 --> 02:36:18,040 >> INTERESTING QUESTION. 3736 02:36:18,040 --> 02:36:20,440 I WOULD INVITE OTHERS IN THE 3737 02:36:20,440 --> 02:36:22,320 ROOM, NICOLE AND ANNA, IF YOU'RE 3738 02:36:22,320 --> 02:36:24,520 STILL THERE, TO HELP WITH THIS. 3739 02:36:24,520 --> 02:36:28,040 THERE'S A LOT OF PERSPECTIVES 3740 02:36:28,040 --> 02:36:34,480 WITH YOUR QUESTION. 3741 02:36:34,480 --> 02:36:36,720 CLEARLY, EVERYBODY PARTICIPATING 3742 02:36:36,720 --> 02:36:38,520 ON THE MEMBER COUNTRIES HAVE 3743 02:36:38,520 --> 02:36:39,800 SOME BIAS OR ECONOMIC INTEREST, 3744 02:36:39,800 --> 02:36:40,000 RIGHT? 3745 02:36:40,000 --> 02:36:42,760 EVEN THE U.S. 3746 02:36:42,760 --> 02:36:46,840 WE HAVE OUR PRIORITIES FOR 3747 02:36:46,840 --> 02:36:50,880 ENSURING, YOU KNOW, OUR NEEDS 3748 02:36:50,880 --> 02:36:58,880 ARE MET, OBLIGATIONS TO TOSCO, 3749 02:36:58,880 --> 02:37:00,960 FISHRA, COSMETIC ACT, WE'RE 3750 02:37:00,960 --> 02:37:05,120 COMING IN WITH SPECIAL INTEREST, 3751 02:37:05,120 --> 02:37:07,640 HOWEVER THERE'S CONSENSUS FOR 3752 02:37:07,640 --> 02:37:10,920 ANYTHING TO MOVE FORWARD, SO 3753 02:37:10,920 --> 02:37:12,360 WE'VE HAD OPPORTUNITIES, 3754 02:37:12,360 --> 02:37:14,440 SITUATIONS WHERE, YOU KNOW, 3755 02:37:14,440 --> 02:37:15,880 THE -- MAYBE EUROPEAN COUNTRIES 3756 02:37:15,880 --> 02:37:18,280 ARE ADVOCATING FOR SOMETHING 3757 02:37:18,280 --> 02:37:23,960 THAT DOESN'T ALIGN WITH THE U.S. 3758 02:37:23,960 --> 02:37:26,320 REGULATORY PRIORITIES, OR OUR 3759 02:37:26,320 --> 02:37:27,880 PROGRAMS, AND SO WE HAVE TO WORK 3760 02:37:27,880 --> 02:37:31,400 THOSE OUT, WE CAN REACH 3761 02:37:31,400 --> 02:37:32,000 CONSENSUS. 3762 02:37:32,000 --> 02:37:33,040 IT'S A GENERIC ANSWER BUT 3763 02:37:33,040 --> 02:37:35,880 THERE'S TRUTH IN THE FACT WE ALL 3764 02:37:35,880 --> 02:37:39,360 DO COME WITH SOME SENSE OF BIAS 3765 02:37:39,360 --> 02:37:44,400 BUT THAT'S GETS HARMONIZED, IN 3766 02:37:44,400 --> 02:37:47,800 OUR MUTUAL AGREEMENT OF THE -- 3767 02:37:47,800 --> 02:37:50,880 AND CONSENSUS OF TEST GUIDELINES 3768 02:37:50,880 --> 02:37:53,600 THAT GO FORWARD. 3769 02:37:53,600 --> 02:37:56,840 THE SECOND QUESTION WAS ANALYSES 3770 02:37:56,840 --> 02:37:58,080 SCIENTIFICALLY BASED -- REPEAT 3771 02:37:58,080 --> 02:37:59,280 THAT AS WELL. 3772 02:37:59,280 --> 02:38:01,200 >> IS THERE AN INTERNATIONAL 3773 02:38:01,200 --> 02:38:03,560 STANDARD TO ENSURE THAT ANALYSES 3774 02:38:03,560 --> 02:38:05,240 ARE SCIENTIFICALLY BASED AND DO 3775 02:38:05,240 --> 02:38:10,040 NOT REFLECT PERSONAL OR 3776 02:38:10,040 --> 02:38:10,680 INSTITUTIONAL INTERESTS? 3777 02:38:10,680 --> 02:38:12,680 >> I'M GOING TO TURN TO NICOLE, 3778 02:38:12,680 --> 02:38:14,480 MAYBE YOU COULD HELP ME. 3779 02:38:14,480 --> 02:38:16,080 >> SURE, YEAH, ABSOLUTELY. 3780 02:38:16,080 --> 02:38:17,480 FIRST, I'LL JUST SAY I AGREE 3781 02:38:17,480 --> 02:38:18,600 WITH YOUR ANSWER ON THE FIRST 3782 02:38:18,600 --> 02:38:21,320 HALF OF THE QUESTION. 3783 02:38:21,320 --> 02:38:24,280 I THINK THAT EVEN THOUGH IT'S 3784 02:38:24,280 --> 02:38:26,360 SOMETIMES A PAINFUL PROCESS, THE 3785 02:38:26,360 --> 02:38:29,080 REQUIREMENT AT THE WNT TO 3786 02:38:29,080 --> 02:38:30,600 ACHIEVE 100% CONSENSUS BEFORE 3787 02:38:30,600 --> 02:38:33,120 THE ANY METHOD IS ADOPTED INTO A 3788 02:38:33,120 --> 02:38:35,200 TEST GUIDELINE OR GUIDANCE 3789 02:38:35,200 --> 02:38:37,200 DOCUMENT IS APPROVED THAT FALLS 3790 02:38:37,200 --> 02:38:40,240 UNDER WORKING PARTY, THAT 100% 3791 02:38:40,240 --> 02:38:42,560 CONSENSUS REALLY ENSURES THAT NO 3792 02:38:42,560 --> 02:38:44,080 INDIVIDUAL COUNTRY OR INDIVIDUAL 3793 02:38:44,080 --> 02:38:46,600 REGION'S BY AS IS 3794 02:38:46,600 --> 02:38:47,600 OVERREPRESENTED, BECAUSE THERE'S 3795 02:38:47,600 --> 02:38:50,920 THIS LEGAL FRAMEWORK OF THE 3796 02:38:50,920 --> 02:38:52,880 MUTUAL ACCEPTANCE OF DATA WHICH 3797 02:38:52,880 --> 02:38:55,520 REQUIRES THAT ANY DATA THAT'S 3798 02:38:55,520 --> 02:38:58,000 SUBMITTED UNDER AN OECD TEST 3799 02:38:58,000 --> 02:39:01,160 GUIDELINE IS CONSIDERED BY ANY 3800 02:39:01,160 --> 02:39:02,960 MEMBER COUNTRY SO ACHIEVING THAT 3801 02:39:02,960 --> 02:39:03,960 CONSENSUS CREATES THAT BALANCE 3802 02:39:03,960 --> 02:39:06,200 AND I THINK REALLY PROTECTS 3803 02:39:06,200 --> 02:39:07,320 AGAINST ANY BIAS. 3804 02:39:07,320 --> 02:39:09,080 IN TERMS OF THAT INTERNATIONAL 3805 02:39:09,080 --> 02:39:10,280 SCIENTIFIC STANDARD I MEAN 3806 02:39:10,280 --> 02:39:12,520 THAT'S REALLY THE ROLE OF THE 3807 02:39:12,520 --> 02:39:15,520 OECD EXPERT GROUPS, AND SO THE 3808 02:39:15,520 --> 02:39:17,240 EXPERT GROUPS CONSIST AGAIN OF 3809 02:39:17,240 --> 02:39:20,280 SUBJECT MATTER EXPERTS THAT ARE 3810 02:39:20,280 --> 02:39:22,080 NOMINATED FROM THE REGIONS 3811 02:39:22,080 --> 02:39:23,400 REPRESENTED BY THE 38 DIFFERENT 3812 02:39:23,400 --> 02:39:25,920 MEMBER COUNTRIES. 3813 02:39:25,920 --> 02:39:28,440 SO HAVING THAT GLOBAL SPREAD OF 3814 02:39:28,440 --> 02:39:31,840 EXPERTS AND THAT VERY DIVERSE 3815 02:39:31,840 --> 02:39:33,560 REPRESENTATION ACROSS DIFFERENT 3816 02:39:33,560 --> 02:39:35,440 REGIONS ENSURES HIGH QUALITY 3817 02:39:35,440 --> 02:39:37,520 SCIENTIFIC REVIEW, BUT THEN 3818 02:39:37,520 --> 02:39:38,280 THERE'S ALSO OTHER STANDARDS, 3819 02:39:38,280 --> 02:39:40,680 CHARLES TALKED ABOUT A COUPLE IN 3820 02:39:40,680 --> 02:39:45,640 HIS PRESENTATION. 3821 02:39:45,640 --> 02:39:49,360 SO GOP STANDARDS, THE FRAND 3822 02:39:49,360 --> 02:39:50,880 DECLARATION BASICALLY MEANS THAT 3823 02:39:50,880 --> 02:39:54,160 YOUR METHOD HAS TO BE REASONABLY 3824 02:39:54,160 --> 02:39:55,480 ACCESSIBLE, SO IT CAN'T BE, YOU 3825 02:39:55,480 --> 02:39:56,680 KNOW, A PROPRIETARY METHOD WITH 3826 02:39:56,680 --> 02:39:58,320 A SUPER HIGH LICENSING FEE 3827 02:39:58,320 --> 02:39:59,880 THAT'S ONLY AVAILABLE THROUGH 3828 02:39:59,880 --> 02:40:01,720 ONE CRO IN THE ENTIRE WORLD, 3829 02:40:01,720 --> 02:40:02,320 RIGHT? 3830 02:40:02,320 --> 02:40:04,280 SO THEY HAVE PUT A LOT OF THESE 3831 02:40:04,280 --> 02:40:06,760 STANDARDS IN PLACE TO ENSURE NOT 3832 02:40:06,760 --> 02:40:09,400 ONLY HIGH SCIENTIFIC QUALITY BUT 3833 02:40:09,400 --> 02:40:11,800 REASONABLE ACCESS TO METHODS 3834 02:40:11,800 --> 02:40:15,960 THAT ARE CODIFIED IN OECD TEST 3835 02:40:15,960 --> 02:40:24,160 GUIDELINES. 3836 02:40:24,160 --> 02:40:25,160 ANY OTHER QUESTIONS FROM ONLINE 3837 02:40:25,160 --> 02:40:29,280 OR IN THE ROOM? 3838 02:40:29,280 --> 02:40:33,600 NO? 3839 02:40:33,600 --> 02:40:33,920 OKAY. 3840 02:40:33,920 --> 02:40:35,880 WE'RE GOING TO TAKE OUR BREAK, 3841 02:40:35,880 --> 02:40:37,800 JUST A FEW MINUTES EARLY. 3842 02:40:37,800 --> 02:40:40,640 AND SO WE'LL TAKE A SLIGHTLY 3843 02:40:40,640 --> 02:40:42,360 EXTENDED BREAK OF 20 MINUTES, 3844 02:40:42,360 --> 02:40:48,000 AND WE'LL BE BACK HERE AT 2:30. 3845 02:40:48,000 --> 02:40:50,120 I WILL PUT UP THAT PLACEHOLDER 3846 02:40:50,120 --> 02:40:52,520 SCREEN AND WE WILL SEE YOU ALL 3847 02:40:52,520 --> 02:40:56,200 IN 20 MINUTES. 3848 02:40:56,200 --> 02:41:03,360 >> WE'RE GOING TO GET STARTED 3849 02:41:03,360 --> 02:41:03,760 AGAIN. 3850 02:41:03,760 --> 02:41:05,240 THE AFTERNOON SESSION, WE HAVE 3851 02:41:05,240 --> 02:41:09,360 TWO MORE TALKS FOR YOU THIS 3852 02:41:09,360 --> 02:41:10,800 AFTERNOON, AND VERY EXCITED 3853 02:41:10,800 --> 02:41:12,760 ABOUT THEM. 3854 02:41:12,760 --> 02:41:19,280 FIRST LET ME PULL UP THE FIRST 3855 02:41:19,280 --> 02:41:21,760 PRESENTATION. 3856 02:41:21,760 --> 02:41:24,840 SO, SHARI PRICE WILL TALK ON 3857 02:41:24,840 --> 02:41:26,720 BEHALF OF THE NATIONAL CANCER 3858 02:41:26,720 --> 02:41:30,960 INSTITUTE, CART T CELL IN VITRO 3859 02:41:30,960 --> 02:41:32,600 SAFETY TESTING STRATEGIES. 3860 02:41:32,600 --> 02:41:40,920 OVER TO YOU. 3861 02:41:40,920 --> 02:41:41,480 THANKS. 3862 02:41:41,480 --> 02:41:43,080 LET ME HIDE THE CONTROLS. 3863 02:41:43,080 --> 02:41:45,600 YOU SHOULD BE ABLE TO CLICK. 3864 02:41:45,600 --> 02:41:47,280 >> GREAT. 3865 02:41:47,280 --> 02:41:50,440 THANK YOU SO MUCH. 3866 02:41:50,440 --> 02:41:55,160 I'M GOING TO TALK ABOUT, LIKE 3867 02:41:55,160 --> 02:41:57,360 NICOLE SAID, SAFETY TESTING 3868 02:41:57,360 --> 02:41:58,880 STRATEGIES FOR CAR T CELLS. 3869 02:41:58,880 --> 02:42:02,360 ACTUALLY THIS IS GOING TO BE AN 3870 02:42:02,360 --> 02:42:05,760 EXAMPLE OF THE NAMs EFFORT. 3871 02:42:05,760 --> 02:42:07,280 THIS IS ACTUALLY -- WE DO IN 3872 02:42:07,280 --> 02:42:08,600 VITRO TESTING IN OUR LAB, THIS 3873 02:42:08,600 --> 02:42:09,920 IS AN EXAMPLE OF THE EFFORTS 3874 02:42:09,920 --> 02:42:11,360 PEOPLE ARE INTERESTED IN. 3875 02:42:11,360 --> 02:42:13,880 WHAT I WANT TO EMPHASIZE IS IN 3876 02:42:13,880 --> 02:42:17,040 THIS CASE ACTUALLY USING THESE 3877 02:42:17,040 --> 02:42:18,520 IN VITRO METHODS FOR SAFETY 3878 02:42:18,520 --> 02:42:20,840 TESTING OF CAR T CELLS MAKES A 3879 02:42:20,840 --> 02:42:25,320 LOT OF SENSE. 3880 02:42:25,320 --> 02:42:27,840 I'LL EXPLAIN WHY. 3881 02:42:27,840 --> 02:42:30,040 ONE OF THE THINGS THAT HAS TO 3882 02:42:30,040 --> 02:42:33,480 HAPPEN BEFORE CAR T CELLS GO 3883 02:42:33,480 --> 02:42:34,760 INTO HUMANS BEFORE FIRST IN MAN 3884 02:42:34,760 --> 02:42:37,080 YOU NEED TO ASSESS BINDING OF 3885 02:42:37,080 --> 02:42:38,440 THE CAR T CELLS. 3886 02:42:38,440 --> 02:42:43,240 WE'RE GOING BACK IN TIME TO TALK 3887 02:42:43,240 --> 02:42:44,920 ABOUT MONOCLONAL ANTIBODIES 3888 02:42:44,920 --> 02:42:45,680 FIRST. 3889 02:42:45,680 --> 02:42:47,320 1997 FDA POINTS TO CONSIDER 3890 02:42:47,320 --> 02:42:51,400 DOCUMENT THEY STATE CLEARLY THAT 3891 02:42:51,400 --> 02:42:52,680 NON-TARGET BINDING OF A 3892 02:42:52,680 --> 02:42:54,240 MONOCLONAL ANTIBODY PARTICULARLY 3893 02:42:54,240 --> 02:42:55,840 THOSE THAT ARE PHARMACOLOGICALLY 3894 02:42:55,840 --> 02:42:58,720 ACTIVE CAN HAVE VERY SERIOUS 3895 02:42:58,720 --> 02:42:59,560 CONSEQUENCES. 3896 02:42:59,560 --> 02:43:02,760 THEREFORE YOU NEED TO TEST FOR 3897 02:43:02,760 --> 02:43:03,960 ON AND OFF-TARGET BINDING BY 3898 02:43:03,960 --> 02:43:09,840 SOME WAY BEFORE YOU GO INTO 3899 02:43:09,840 --> 02:43:10,360 HUMANS. 3900 02:43:10,360 --> 02:43:13,840 SO HOW DOES THIS APPLY TO CAR T 3901 02:43:13,840 --> 02:43:14,320 CELLS? 3902 02:43:14,320 --> 02:43:16,240 IF WE GO TO -- IS THIS THE 3903 02:43:16,240 --> 02:43:16,640 MOUSE? 3904 02:43:16,640 --> 02:43:18,040 DOES IT SHOW UP? 3905 02:43:18,040 --> 02:43:18,560 GREAT. 3906 02:43:18,560 --> 02:43:23,000 IF WE GO TO AN ANTIBODY, 3907 02:43:23,000 --> 02:43:24,440 THINKING ABOUT THE CDR, THIS IS 3908 02:43:24,440 --> 02:43:26,680 THE PART OF THE ANTIBODY THAT IS 3909 02:43:26,680 --> 02:43:28,800 BINDING TO TARGET, THE PART THAT 3910 02:43:28,800 --> 02:43:30,880 PEOPLE CARE ABOUT. 3911 02:43:30,880 --> 02:43:32,600 WHEN THAT BINDING DOMAIN BINDS 3912 02:43:32,600 --> 02:43:34,800 IN THE WRONG PLACE, AND CALLS IN 3913 02:43:34,800 --> 02:43:37,560 THE CAVALRY, YOU CAN HAVE 3914 02:43:37,560 --> 02:43:39,800 UNINTENDED TOXIC EFFECTS. 3915 02:43:39,800 --> 02:43:48,160 SO WHEN THEY MAKE CHIMERIC 3916 02:43:48,160 --> 02:43:50,360 ANTIGEN RECEPTOR CAR T CELLS 3917 02:43:50,360 --> 02:43:53,240 THEY USE IT AS BINDING DOMAIN 3918 02:43:53,240 --> 02:43:54,960 FOR GENETICALLY MODIFIED T CELL, 3919 02:43:54,960 --> 02:43:59,080 THEN THIS CAR, AS IT'S CALLED, 3920 02:43:59,080 --> 02:44:02,840 HAS SOME ACTIVATION DOMAINS. 3921 02:44:02,840 --> 02:44:05,000 ONE THIS IS SCFE BINDS TO HAR 3922 02:44:05,000 --> 02:44:09,720 GET THAT LEADS TO BINDING OF T 3923 02:44:09,720 --> 02:44:19,680 CELL AND YOU GO FOR YOUR, Q 3924 02:44:19,680 --> 02:44:21,000 UOTE, THERAPEUTIC OUTPUT. 3925 02:44:21,000 --> 02:44:23,920 RECOGNIZE CANCER CELL AND KILL 3926 02:44:23,920 --> 02:44:24,560 IT. 3927 02:44:24,560 --> 02:44:27,880 IN THE CASE OF CAR TS, THE 3928 02:44:27,880 --> 02:44:29,280 DOMAIN IS DERIVED FROM CDR, YOU 3929 02:44:29,280 --> 02:44:31,760 NEED TO LOOK AND UNDERSTAND 3930 02:44:31,760 --> 02:44:33,440 WHERE THE CDR IS BINDING, IS IT 3931 02:44:33,440 --> 02:44:34,760 BINDING TO TARGET OR SOMETHING 3932 02:44:34,760 --> 02:44:37,800 ELSE OR IN PLACES WE EXPECT, OR 3933 02:44:37,800 --> 02:44:40,760 IN PLACES WE DIDN'T EXPECT? 3934 02:44:40,760 --> 02:44:43,520 WHEN WE THINK ABOUT HOW CAR Ts 3935 02:44:43,520 --> 02:44:46,560 WILL BIND YOU CAN HAVE ON TARGET 3936 02:44:46,560 --> 02:44:50,000 ON TUMOR, WHAT YOU WANT TO 3937 02:44:50,000 --> 02:44:51,920 HAPPEN, BUT IF YOU BUST UP TUMOR 3938 02:44:51,920 --> 02:44:56,000 CELLS TOO FAST YOU CAN END UP 3939 02:44:56,000 --> 02:44:56,880 WITH CYTOKINE RELEASE SYNDROME, 3940 02:44:56,880 --> 02:44:58,520 THINGS LIKE THAT. 3941 02:44:58,520 --> 02:45:01,560 YOU CAN HAVE ON TARGET OFF TUMOR 3942 02:45:01,560 --> 02:45:03,080 BINDING, A GOOD EXAMPLE WOULD BE 3943 02:45:03,080 --> 02:45:04,640 IF YOU'RE TRYING TO KILL SOME 3944 02:45:04,640 --> 02:45:07,280 KIND OF B CELL LYMPHOMA USING 3945 02:45:07,280 --> 02:45:08,440 SOMETHING THAT'S TARGETED TO 3946 02:45:08,440 --> 02:45:11,200 CD19 YOU MIGHT ALSO BE KILLING 3947 02:45:11,200 --> 02:45:12,400 HEALTHY B CELLS, OR ANOTHER 3948 02:45:12,400 --> 02:45:14,240 EXAMPLE THIS IS A GOOD ONE, WHEN 3949 02:45:14,240 --> 02:45:17,760 YOU'RE TRYING TO KILL SOME KIND 3950 02:45:17,760 --> 02:45:19,400 OF CANCER WITH HER-2 ANTIBODY 3951 02:45:19,400 --> 02:45:20,720 BUT END UP WITH CARDIOVASCULAR 3952 02:45:20,720 --> 02:45:21,680 TOXICITY BECAUSE IN THE EARLY 3953 02:45:21,680 --> 02:45:23,560 DAYS NOBODY BOTHERED TO LOOK TO 3954 02:45:23,560 --> 02:45:28,200 SEE HER-2 IS EXPRESSED BY 3955 02:45:28,200 --> 02:45:30,160 CARDIOMYOCYTES AND HEPATOCYTES 3956 02:45:30,160 --> 02:45:33,440 AND SCHWANN CELLS, EXPLAINING 3957 02:45:33,440 --> 02:45:39,240 SEEMINGLY OFF-TARGET TOXICITY 3958 02:45:39,240 --> 02:45:41,320 ORIGINALLY OBSERVED IN ANTI-HER2 3959 02:45:41,320 --> 02:45:42,520 DIRECTED COMPOUNDS. 3960 02:45:42,520 --> 02:45:44,240 FINALLY OFF TARGET OFF TUMOR 3961 02:45:44,240 --> 02:45:46,120 BINDING, SOME PRECEDENT IN THE 3962 02:45:46,120 --> 02:45:52,160 CAR T REALM, MOST FAMOUS WAS DUE 3963 02:45:52,160 --> 02:45:53,600 TO CROSS-REACTIVE BINDING WITH 3964 02:45:53,600 --> 02:45:54,800 PROTEIN TITAN, SO IN THIS 3965 02:45:54,800 --> 02:45:58,800 INSTANCE CAR T WAS DIRECTED 3966 02:45:58,800 --> 02:46:06,680 AGAINST MAY JAY 3, CROSS REACTED 3967 02:46:06,680 --> 02:46:08,560 WITH TITAN, SEVERAL PEOPLE GOT 3968 02:46:08,560 --> 02:46:10,880 VERY SICK, SEVERAL PEOPLE DIED. 3969 02:46:10,880 --> 02:46:12,080 AND SO WE MOVED FORWARD. 3970 02:46:12,080 --> 02:46:13,360 AT THAT TIME THEY DIDN'T THINK 3971 02:46:13,360 --> 02:46:16,120 THERE WAS A WAY TO ACTUALLY TEST 3972 02:46:16,120 --> 02:46:18,320 THE ON AND OFF TARGET BINDING OF 3973 02:46:18,320 --> 02:46:20,360 CAR Ts BECAUSE YOU HAD TO TEST 3974 02:46:20,360 --> 02:46:22,360 THE WHOLE T CELL, THAT'S NOT 3975 02:46:22,360 --> 02:46:24,760 REALLY THE CASE. 3976 02:46:24,760 --> 02:46:27,400 SO, HOW THEN CAN YOU TEST HOW A 3977 02:46:27,400 --> 02:46:29,800 CAR T IS GOING TO BIND? 3978 02:46:29,800 --> 02:46:32,080 IF WE GO BACK INTO THE ANTIBODY 3979 02:46:32,080 --> 02:46:34,280 WORLD AND THINK ABOUT TISSUE 3980 02:46:34,280 --> 02:46:37,040 CROSS-REACTIVITY STUDIES THAT'S 3981 02:46:37,040 --> 02:46:39,000 THE GOLD STANDARD APPROACH TO 3982 02:46:39,000 --> 02:46:41,080 ASSESSING ON AND OFF TARGET 3983 02:46:41,080 --> 02:46:41,640 BINDING. 3984 02:46:41,640 --> 02:46:42,160 THAT'S DONE USING 3985 02:46:42,160 --> 02:46:44,920 IMMUNOLABELLING WHERE YOU TAKE A 3986 02:46:44,920 --> 02:46:48,640 TISSUE, APPLY THE ANTIBODY, 3987 02:46:48,640 --> 02:46:48,960 USING STANDARD 3988 02:46:48,960 --> 02:46:50,320 IMMUNOHISTOCHEMISTRY 3989 02:46:50,320 --> 02:46:51,720 METHODOLOGY, LOOK UNDERSTOOD A 3990 02:46:51,720 --> 02:46:52,680 MICROSCOPE, LOOK WHERE IT'S 3991 02:46:52,680 --> 02:46:53,960 STAINED, REPORT OUT ON THAT. 3992 02:46:53,960 --> 02:46:57,800 IN THE CASE OF CAR T YOU CAN'T 3993 02:46:57,800 --> 02:46:59,920 USE THE ENTIRE CAR T TO STAIN 3994 02:46:59,920 --> 02:47:01,440 BECAUSE IT'S BIG AND CLUNKY. 3995 02:47:01,440 --> 02:47:04,040 IF THEY ARE DOING 3996 02:47:04,040 --> 02:47:06,440 IMMUNOLABELLING TO ASSESS CAR T 3997 02:47:06,440 --> 02:47:10,440 BINDING THEY TAKE THE SCFV OFF 3998 02:47:10,440 --> 02:47:14,240 THE EXTRACELLULAR DOMAIN AND 3999 02:47:14,240 --> 02:47:15,560 MAKE IT INTO 4000 02:47:15,560 --> 02:47:16,880 IMMUNOHISTOCHEMISTRIATION WITH 4001 02:47:16,880 --> 02:47:18,720 FC FUSION PROTEIN AND USE LIKE 4002 02:47:18,720 --> 02:47:19,600 AN ANTIBODY. 4003 02:47:19,600 --> 02:47:23,440 THAT'S FINE, YOU CAN GET SOME 4004 02:47:23,440 --> 02:47:24,920 ABOUT HISTOLOGIC YAM CONTEXT OUT 4005 02:47:24,920 --> 02:47:26,960 OF WHERE THAT CDR IS BINDING BUT 4006 02:47:26,960 --> 02:47:28,480 YOU'RE NOT REALLY ACTUALLY 4007 02:47:28,480 --> 02:47:32,040 LOOKING AT THE FINAL CLINICAL 4008 02:47:32,040 --> 02:47:32,320 CANDIDATE. 4009 02:47:32,320 --> 02:47:36,000 WHEN YOU CUT CDR OFF OR CUT 4010 02:47:36,000 --> 02:47:38,200 EXTRACELLULAR DOMAIN OFF, ANDS 4011 02:47:38,200 --> 02:47:39,760 PUT IT ON TAIL, YOU'RE MAKING 4012 02:47:39,760 --> 02:47:42,880 PERMANENT CHANGE TO THE MOLECULE 4013 02:47:42,880 --> 02:47:46,280 AND CAN POSSIBLY AND LIKELY ARE 4014 02:47:46,280 --> 02:47:47,400 CHANGING ITS BINDING 4015 02:47:47,400 --> 02:47:47,760 CHARACTERISTICS. 4016 02:47:47,760 --> 02:47:50,880 SO ANOTHER WAY CAN YOU DO THIS 4017 02:47:50,880 --> 02:47:58,120 IS USING ARRAY-BASED SCREENS. 4018 02:47:58,120 --> 02:48:01,600 THERE'S A LIBRARY OF KNOWN 4019 02:48:01,600 --> 02:48:03,040 MEMBRANE PROTEINS TO TRANSFECT, 4020 02:48:03,040 --> 02:48:04,480 EXPRESS, YOU CAN TAKE AN 4021 02:48:04,480 --> 02:48:05,960 ANTIBODY OR ANTIBODY SURROGATE 4022 02:48:05,960 --> 02:48:08,080 OR THE WHOLE CAR T AND USE IT 4023 02:48:08,080 --> 02:48:11,000 ESSENTIALLY TO STICK IT DOWN AND 4024 02:48:11,000 --> 02:48:14,320 SEE WHERE IT STUCK ON THIS SET 4025 02:48:14,320 --> 02:48:16,200 OF TRANSFECTED CELLS AND THEN 4026 02:48:16,200 --> 02:48:17,840 THIS IS AN EXAMPLE OF WHAT A HIT 4027 02:48:17,840 --> 02:48:18,680 LOOKS LIKE. 4028 02:48:18,680 --> 02:48:21,320 EXPECTING TO SEE A HIT IN THE 4029 02:48:21,320 --> 02:48:22,720 PLACE USING THE TARGET THAT 4030 02:48:22,720 --> 02:48:24,440 YOU'RE TRYING TO SEE, AND IF YOU 4031 02:48:24,440 --> 02:48:26,480 HAD SOMETHING THAT WAS AN 4032 02:48:26,480 --> 02:48:27,520 OFF-TARGET BINDING YOU WOULD SEE 4033 02:48:27,520 --> 02:48:28,040 THAT TOO. 4034 02:48:28,040 --> 02:48:34,480 THERE ARE PEOPLE THAT DO PROTEIN 4035 02:48:34,480 --> 02:48:40,840 CLIP SCREENS, POPULAR BUT LOST 4036 02:48:40,840 --> 02:48:41,720 FAVOR, IN SITU HYBRIDIZATION 4037 02:48:41,720 --> 02:48:45,320 ONLY TELLS YOU WHERE THE TARGET 4038 02:48:45,320 --> 02:48:46,960 MIGHT BE EXPRESSIONED, FLOW 4039 02:48:46,960 --> 02:48:48,040 CYTOMETRY, ET CETERA. 4040 02:48:48,040 --> 02:48:49,280 IN OUR LAB WHAT WE'RE GOING TO 4041 02:48:49,280 --> 02:48:52,760 TRY AND DO IS USE HUMAN INDUCED 4042 02:48:52,760 --> 02:48:54,480 PLURIPOTENT STEM CELLS DERIVED 4043 02:48:54,480 --> 02:48:55,720 CELLS, RATHER, AS MODEL OF 4044 02:48:55,720 --> 02:49:00,160 NORMAL CELLS IN A CO-CULTURE 4045 02:49:00,160 --> 02:49:01,160 SYSTEM WITH CAR Ts, THIS IS 4046 02:49:01,160 --> 02:49:02,600 THE WAY THIS ASSAY WILL LOOK. 4047 02:49:02,600 --> 02:49:06,320 CELL 4048 02:49:06,320 --> 02:49:12,160 CELL TYPES ARE INTENDED TO BE 4049 02:49:12,160 --> 02:49:13,440 BROADLY REPRESENTED FOR 4050 02:49:13,440 --> 02:49:17,600 TOXICITY, ENDOTHELIAL, NEURON, 4051 02:49:17,600 --> 02:49:18,520 HEPATOCYTE, ET CETERA. 4052 02:49:18,520 --> 02:49:20,000 SORRY, MY THROAT IS DRY. 4053 02:49:20,000 --> 02:49:24,920 THE WAY THIS ASSAY LOOKS IS 4054 02:49:24,920 --> 02:49:29,760 WE'VE GOT OUR DIFFERENTIATED 4055 02:49:29,760 --> 02:49:30,720 PLURIPOTENT STEM CELLS IN DISH, 4056 02:49:30,720 --> 02:49:32,160 CAR Ts TO THE DISH. 4057 02:49:32,160 --> 02:49:33,880 IF CAR Ts DO NOT RECOGNIZE 4058 02:49:33,880 --> 02:49:35,680 THEIR TARGET AND DO NOT BIND, 4059 02:49:35,680 --> 02:49:36,440 EVERYBODY STAYS HAPPY. 4060 02:49:36,440 --> 02:49:46,680 WE HAVE A GOOD DAY. 4061 02:49:46,680 --> 02:49:48,120 IF THE CAR Ts RECOGNIZE 4062 02:49:48,120 --> 02:49:50,160 SOMETHING IS TARGET, THEY BIND 4063 02:49:50,160 --> 02:49:54,320 AND ACTIVATE, AND THEN THEY 4064 02:49:54,320 --> 02:49:54,640 KILL. 4065 02:49:54,640 --> 02:49:56,200 AND SO THIS IS WHAT WE'RE IN THE 4066 02:49:56,200 --> 02:49:56,960 BUSINESS OF DOING. 4067 02:49:56,960 --> 02:49:59,400 DID THE CAR T BIND, DID IT 4068 02:49:59,400 --> 02:50:00,240 ACTIVATE, DID IT KILL? 4069 02:50:00,240 --> 02:50:01,880 THOSE ARE THE THREE QUESTIONS WE 4070 02:50:01,880 --> 02:50:04,840 WANT TO KNOW. 4071 02:50:04,840 --> 02:50:07,600 SO WE HAVE -- AS A PRECEDENT FOR 4072 02:50:07,600 --> 02:50:11,440 THIS STYLE OF ASSAY THERE WAS A 4073 02:50:11,440 --> 02:50:15,160 PAPER PUBLISHED BY FRY ET AL. IN 4074 02:50:15,160 --> 02:50:18,160 2021 USING A CD33 SPECIFIC CAR T 4075 02:50:18,160 --> 02:50:20,600 CELL, USED A PANEL OF 4076 02:50:20,600 --> 02:50:23,280 PLURIPOTENT STEM CELL DERIVED 4077 02:50:23,280 --> 02:50:27,760 CELL TYPES THEY DIFFERENTIATED, 4078 02:50:27,760 --> 02:50:29,840 USED POSITIVE CONTROL, 14 CELL, 4079 02:50:29,840 --> 02:50:31,600 CO-CULTURE ASSAY, READOUT IN 4080 02:50:31,600 --> 02:50:33,040 THIS CASE WAS FOR T-CELL 4081 02:50:33,040 --> 02:50:35,560 ACTIVATION LOOKING AT INTERFERON 4082 02:50:35,560 --> 02:50:36,520 GAMMA RELEASE. 4083 02:50:36,520 --> 02:50:38,960 INTERESTINGLY, THIS WAS THE ONLY 4084 02:50:38,960 --> 02:50:41,480 STUDY THAT WAS USED TO SUPPORT 4085 02:50:41,480 --> 02:50:42,800 THE IND FILING, ONLY SAFETY 4086 02:50:42,800 --> 02:50:43,240 STUDY. 4087 02:50:43,240 --> 02:50:45,480 THEY DIDN'T DO ANIMAL STUDIES. 4088 02:50:45,480 --> 02:50:47,520 LET'S TALK ABOUT HOW CAN YOU DO 4089 02:50:47,520 --> 02:50:49,680 AN ANIMAL STUDY WITH A CAR T 4090 02:50:49,680 --> 02:50:50,560 CELL? 4091 02:50:50,560 --> 02:50:53,520 YOU'VE GOT A HUMAN CAR T CELL 4092 02:50:53,520 --> 02:50:55,360 GENETICALLY MODIFIED WITH HUMAN 4093 02:50:55,360 --> 02:50:55,960 CHIMERIC ANTIGEN RECEPTOR, 4094 02:50:55,960 --> 02:50:58,120 RIGHT? YOU PUT THAT INTO AN 4095 02:50:58,120 --> 02:51:00,640 ANIMAL, YOU'RE GOING TO HAVE A 4096 02:51:00,640 --> 02:51:01,520 BIG PROBLEM. 4097 02:51:01,520 --> 02:51:04,560 IT'S GOING TO REJECT. 4098 02:51:04,560 --> 02:51:08,200 YOU'LL HAVE GRAFT-VERSUS-HOST, A 4099 02:51:08,200 --> 02:51:09,880 BIG MESS, NOT RELEVANT, THEN 4100 02:51:09,880 --> 02:51:15,320 INTO IMMOW COMPROMISED MOUSE. 4101 02:51:15,320 --> 02:51:17,120 IN THE CASE OF THESE CAR T 4102 02:51:17,120 --> 02:51:18,800 CELLS, IF WE CAN USE MORE OF 4103 02:51:18,800 --> 02:51:20,640 THESE IN VITRO MODELS IT MAKES A 4104 02:51:20,640 --> 02:51:22,400 LOT MORE SENSE THAN USING 4105 02:51:22,400 --> 02:51:25,480 FURTHER AND FURTHER AND FURTHER 4106 02:51:25,480 --> 02:51:26,480 ENGINEERED ANIMALS. 4107 02:51:26,480 --> 02:51:29,360 SO ANYWAY, THIS IS A PRECEDENT 4108 02:51:29,360 --> 02:51:29,960 FOR THE ASSAY. 4109 02:51:29,960 --> 02:51:32,680 THIS IS WHAT OUR WORKFLOW LOOKS 4110 02:51:32,680 --> 02:51:33,160 LIKE. 4111 02:51:33,160 --> 02:51:37,280 WE PLATE THE CELLS ON DAY ZERO. 4112 02:51:37,280 --> 02:51:38,920 ALLOW THEM TO MATURE FOR ANY 4113 02:51:38,920 --> 02:51:40,440 NUMBER OF DAYS, THEY VARY BY 4114 02:51:40,440 --> 02:51:41,560 CELL TYPE. 4115 02:51:41,560 --> 02:51:42,680 FOR EXAMPLE ENDOTHELIAL CELLS 4116 02:51:42,680 --> 02:51:44,440 NEED THREE DAYS. 4117 02:51:44,440 --> 02:51:46,720 NEURONS NEED 14. 4118 02:51:46,720 --> 02:51:49,120 BUT THEN AFTER MATURATION PERIOD 4119 02:51:49,120 --> 02:51:51,320 ENDED WE ADD THE EXPERIMENTAL 4120 02:51:51,320 --> 02:51:52,960 CAR T OR CONTROL CAR T CELLS, 4121 02:51:52,960 --> 02:51:55,800 AND WE WATCH FOR A PERIOD OF 3 4122 02:51:55,800 --> 02:51:56,040 DAYS. 4123 02:51:56,040 --> 02:51:57,480 WE HAVE SEVERAL DIFFERENT TOOLS 4124 02:51:57,480 --> 02:51:58,320 TO HELP US. 4125 02:51:58,320 --> 02:52:04,440 WE DO HAVE A HAMILTON STAR 4126 02:52:04,440 --> 02:52:09,400 LIQUID ROBOTIC HANDLER TO GET 4127 02:52:09,400 --> 02:52:14,720 PLATED, WE DO CONTINUOUS 4128 02:52:14,720 --> 02:52:15,720 MONITORING, LDH RELEASE, 4129 02:52:15,720 --> 02:52:16,480 CYTOTOXICITY, ASSAYS AS 4130 02:52:16,480 --> 02:52:17,120 COMPANIONS. 4131 02:52:17,120 --> 02:52:20,840 AND WE ALSO DO CYTOKINE RELEASE. 4132 02:52:20,840 --> 02:52:23,240 SO, AS I MENTIONED, CELL TIMES 4133 02:52:23,240 --> 02:52:25,880 THAT WE'RE -- TYPES IN THIS 4134 02:52:25,880 --> 02:52:28,160 SCREEN ARE INTENDED TO BE 4135 02:52:28,160 --> 02:52:29,240 BROADLY REPRESENTATIVE. 4136 02:52:29,240 --> 02:52:32,200 THE SIX CELL TIMES HERE STARTING 4137 02:52:32,200 --> 02:52:33,880 AT CARDIOMYOCYTES DOWN TO 4138 02:52:33,880 --> 02:52:35,200 HEPATOCYTES ARE THOSE ALREADY 4139 02:52:35,200 --> 02:52:37,800 PUBLISHED IN THE TERRY FRY 4140 02:52:37,800 --> 02:52:38,040 PAPER. 4141 02:52:38,040 --> 02:52:40,200 WE DO HAVE AN INTEREST IN 4142 02:52:40,200 --> 02:52:41,240 PERIPHERAL NEURONS AND WORK 4143 02:52:41,240 --> 02:52:42,280 GOING ON THAT. 4144 02:52:42,280 --> 02:52:45,600 COMING FROM A CLASSIC TISSUE 4145 02:52:45,600 --> 02:52:46,160 CROSS-REACTIVITY BACKGROUND 4146 02:52:46,160 --> 02:52:47,880 THOUGH, I BELIEVE IT'S GOING TO 4147 02:52:47,880 --> 02:52:50,960 BE NICER TO EXPAND THE PANEL A 4148 02:52:50,960 --> 02:52:52,400 LITTLE BIT, PARTICULARLY WHERE 4149 02:52:52,400 --> 02:52:54,360 WE CAN LOOK AT MICROGLIA, 4150 02:52:54,360 --> 02:53:04,880 PARTICULARLY WHERE WE CAN LOOK 4151 02:53:06,280 --> 02:53:07,320 AT INTESTINAL EPITHELIUM, BIG 4152 02:53:07,320 --> 02:53:10,200 HITERS IN THE WORLD OF TOX. 4153 02:53:10,200 --> 02:53:16,040 LET'S TALK ABOUT WHAT READOUTS 4154 02:53:16,040 --> 02:53:16,520 WE'RE DOING. 4155 02:53:16,520 --> 02:53:18,920 IF YOU LOOK AT CO-CULTURE ASSAYS 4156 02:53:18,920 --> 02:53:22,760 YOU GET THIS READOUT OF T-CELL 4157 02:53:22,760 --> 02:53:24,400 ACTIVATION, YOU'LL GET T-CELL 4158 02:53:24,400 --> 02:53:25,400 ACTIVATION PLUS DEGRANULATION 4159 02:53:25,400 --> 02:53:26,640 BUT NEVER ANSWERED THE QUESTION 4160 02:53:26,640 --> 02:53:29,480 DID THE T CELLS KILL THE TARGET? 4161 02:53:29,480 --> 02:53:31,680 AND THAT'S WHAT MATTERS, RIGHT? 4162 02:53:31,680 --> 02:53:32,840 WHO CARES IF YOU ACTIVATE. 4163 02:53:32,840 --> 02:53:37,040 IF 4164 02:53:37,040 --> 02:53:38,920 IT DIDN'T -- IF IT DIDN'T KILL 4165 02:53:38,920 --> 02:53:39,680 ANYTHING WHO CARES. 4166 02:53:39,680 --> 02:53:48,800 WE HAVE A MAESTRO Z INSTRUMENT, 4167 02:53:48,800 --> 02:53:49,560 CONTINUOUS IMPEDANCE. 4168 02:53:49,560 --> 02:53:51,440 IF THE CELLS ARE CONFLUENT AND 4169 02:53:51,440 --> 02:53:53,800 LAY DOWN FLAT THEY WILL IMPEDE 4170 02:53:53,800 --> 02:53:55,080 AN ELECTRICAL CURRENT. 4171 02:53:55,080 --> 02:53:58,600 SO IF YOUR CELLS ARE CONFLUENT, 4172 02:53:58,600 --> 02:54:04,200 HEALTHY, FLAT, THERE'S A HIGH 4173 02:54:04,200 --> 02:54:05,280 IMPEDANCE MEASURED IN OHMS. 4174 02:54:05,280 --> 02:54:07,720 IN I MAKE THEM ANGRY OR SICK OR 4175 02:54:07,720 --> 02:54:08,920 DIE THEY WILL ROUND UP AND LET 4176 02:54:08,920 --> 02:54:15,240 GO OF THE PLATE AND WILL WILL BE 4177 02:54:15,240 --> 02:54:18,000 LESS IMPEDANCE, THAT WILL DROP, 4178 02:54:18,000 --> 02:54:21,280 USE IT AS SURROGATE FOR 4179 02:54:21,280 --> 02:54:21,640 CYTOTOXICITY. 4180 02:54:21,640 --> 02:54:23,480 WHEN YOU HAVE T CELLS IN A PLATE 4181 02:54:23,480 --> 02:54:24,800 AND TARGET CELLS YOU NEED TO 4182 02:54:24,800 --> 02:54:28,960 TELL THE DIFFERENCE BETWEEN 4183 02:54:28,960 --> 02:54:32,360 WHAT'S DYING, RIGHT? STANDARD 4184 02:54:32,360 --> 02:54:34,160 CYTOTOXICITY ASSAY ANYTHING 4185 02:54:34,160 --> 02:54:36,000 COULD BE DYING BUT ONLY THE 4186 02:54:36,000 --> 02:54:38,920 TARGET CELLS ARE STUCK TO THE 4187 02:54:38,920 --> 02:54:41,000 PLATE MAKING THE IMPEDANCE 4188 02:54:41,000 --> 02:54:41,240 READING. 4189 02:54:41,240 --> 02:54:47,160 TO THE RIGHT IS ACTUALLY WHAT 4190 02:54:47,160 --> 02:54:48,960 IMPEDANCE TRACING LOOKS LIKE. 4191 02:54:48,960 --> 02:54:50,800 TIME ZERO, ATTACH AND START 4192 02:54:50,800 --> 02:54:51,120 SPREADING. 4193 02:54:51,120 --> 02:54:52,360 MATURING OVER ALL THIS TIME. 4194 02:54:52,360 --> 02:54:54,200 ALL THE BLIPS HERE ARE WHEN YOU 4195 02:54:54,200 --> 02:54:56,720 TAKE THE PLATE OUT TO FEED CELLS 4196 02:54:56,720 --> 02:55:00,520 OR IMAGE THE CELLS, ET CETERA. 4197 02:55:00,520 --> 02:55:09,720 SO RIGHT HERE AT THIS TIME 4198 02:55:09,720 --> 02:55:13,040 POINT, WE ADDED STOREOSPORIN, 4199 02:55:13,040 --> 02:55:14,080 CELLS GET SICK AND IMPEDENTS 4200 02:55:14,080 --> 02:55:16,760 DROPS OUT. 4201 02:55:16,760 --> 02:55:19,960 IF YOU ADD DETERGENT IT DROPS TO 4202 02:55:19,960 --> 02:55:20,360 ZERO. 4203 02:55:20,360 --> 02:55:21,800 AT LOW DOSE YOU GET A 4204 02:55:21,800 --> 02:55:23,120 CONCENTRATION OF CELLS THAT 4205 02:55:23,120 --> 02:55:27,240 SPREAD OUT AND GET HUGE LIKE 4206 02:55:27,240 --> 02:55:28,240 GIANT PANCAKES AND IMPEDANCE 4207 02:55:28,240 --> 02:55:30,640 GOES WAY UP, THAT'S WHAT LOW 4208 02:55:30,640 --> 02:55:34,640 DOSES ARE UP HERE, AND CURVES 4209 02:55:34,640 --> 02:55:36,240 ARE HIGHER DOSES OF STOREOSPORIN 4210 02:55:36,240 --> 02:55:38,520 FROM WHERE THE CELLS WERE DYING. 4211 02:55:38,520 --> 02:55:40,840 THAT'S ONE READOUT THAT WE HAVE. 4212 02:55:40,840 --> 02:55:44,240 WE ALSO WILL FOLLOW THESE CELLS 4213 02:55:44,240 --> 02:55:47,960 ALONG WITH IMMUNOHISTOCHEMISTRY, 4214 02:55:47,960 --> 02:55:52,200 SO WE CAN DO 4215 02:55:52,200 --> 02:55:53,520 IMMUNOHISTOCHEMISTRY, DIGITAL 4216 02:55:53,520 --> 02:55:55,400 IMAGE ANALYSIS, WESTERN BLOTS, 4217 02:55:55,400 --> 02:56:00,200 FLOW CYTOMETRY, A FEW EXAMPLES 4218 02:56:00,200 --> 02:56:01,840 SHOW THE STAINING, PICTURES ON 4219 02:56:01,840 --> 02:56:03,800 THE OPERA PHOENIX WITH THESE 4220 02:56:03,800 --> 02:56:04,240 CELLS. 4221 02:56:04,240 --> 02:56:10,920 OUR FAVORITE IS THIS CD31 4222 02:56:10,920 --> 02:56:12,000 STAINING OF hIPSC DERIVED 4223 02:56:12,000 --> 02:56:13,880 ENDOTHELIAL CELLS, YOU CAN SEE 4224 02:56:13,880 --> 02:56:15,120 THEM MAKING THE CONNECTIONS. 4225 02:56:15,120 --> 02:56:17,040 WE LIKE THAT ONE. 4226 02:56:17,040 --> 02:56:20,440 IT'S IMPORTANT TO MAKE SURE THAT 4227 02:56:20,440 --> 02:56:21,760 YOUR CONTROL CELLS SUPPLIED 4228 02:56:21,760 --> 02:56:23,480 ACTUALLY REALLY ARE EXPRESSING 4229 02:56:23,480 --> 02:56:25,160 THE TARGET BEFORE YOU START THE 4230 02:56:25,160 --> 02:56:25,640 ASSAY. 4231 02:56:25,640 --> 02:56:27,240 IF YOU GET A HIT SOMEWHERE YOU 4232 02:56:27,240 --> 02:56:29,040 CAN GO BACK AND ASK THE 4233 02:56:29,040 --> 02:56:30,640 QUESTION, DID THIS CELL TYPE 4234 02:56:30,640 --> 02:56:32,600 THAT WE WEREN'T EXPECTING TO 4235 02:56:32,600 --> 02:56:35,640 HAVE A BINDING, DID THIS CELL 4236 02:56:35,640 --> 02:56:38,520 TYPE ACTUALLY EXPRESS A TARGET 4237 02:56:38,520 --> 02:56:39,960 AS WELL. 4238 02:56:39,960 --> 02:56:43,040 WE HAVE SEVERAL BIOCHEMICAL 4239 02:56:43,040 --> 02:56:44,320 READOUTS THAT INCLUDE STANDARD 4240 02:56:44,320 --> 02:56:45,440 CYTOTOXICITY ASSAYS. 4241 02:56:45,440 --> 02:56:49,600 OUR FAVORITE IS THE REALTIME LDH 4242 02:56:49,600 --> 02:56:51,040 GLOW ASSAY BECAUSE IT'S KINETIC 4243 02:56:51,040 --> 02:56:52,680 AND YOU CAN SEE WHAT'S HAPPENING 4244 02:56:52,680 --> 02:56:54,640 ALMOST FROM THE TIME YOU START 4245 02:56:54,640 --> 02:56:55,840 THE CO-CULTURE AND ALSO THAT ONE 4246 02:56:55,840 --> 02:56:57,800 IS NICE BECAUSE YOU ONLY SAMPLE 4247 02:56:57,800 --> 02:57:00,440 TINY BITS OF THE MEDIA AT ONE 4248 02:57:00,440 --> 02:57:01,560 TIME. 4249 02:57:01,560 --> 02:57:03,040 AND THEN ALSO CYTOKINE RELEASE, 4250 02:57:03,040 --> 02:57:06,880 AND SO THIS IS ACTUALLY AN 4251 02:57:06,880 --> 02:57:11,040 EXAMPLE OF CYTOKINE RELEASE FROM 4252 02:57:11,040 --> 02:57:15,320 A CO-CULTURE OF hIPSC 4253 02:57:15,320 --> 02:57:16,160 CARDIOMYOCYTES, CO-CULTURED WITH 4254 02:57:16,160 --> 02:57:18,720 CD33 CAR T OR UNTRANSDUCED CAR 4255 02:57:18,720 --> 02:57:19,040 T. 4256 02:57:19,040 --> 02:57:20,680 AND WHAT YOU CAN SEE HERE IS 4257 02:57:20,680 --> 02:57:24,600 THAT YOU HAVE THE HIGHEST AMOUNT 4258 02:57:24,600 --> 02:57:27,840 OF CYTOKINE RELEASE, POSITIVE 4259 02:57:27,840 --> 02:57:30,200 CONTROL, CD33 POSITIVE, A LITTLE 4260 02:57:30,200 --> 02:57:33,160 BIT OF CYTOKINE RELEASE WITH 4261 02:57:33,160 --> 02:57:35,640 DOWDY NEGATIVE CONTROL CELL. 4262 02:57:35,640 --> 02:57:37,000 THAT HAS MORE TO DO PROBABLY 4263 02:57:37,000 --> 02:57:40,600 WITH THE FACT THE CELLS ARE 4264 02:57:40,600 --> 02:57:41,240 HIGHLY METABOLICALLY ACTIVE AND 4265 02:57:41,240 --> 02:57:42,920 DENSITY IS SO HIGH THEY ARE JUST 4266 02:57:42,920 --> 02:57:43,960 DYING ON THEIR OWN. 4267 02:57:43,960 --> 02:57:45,480 WHAT'S IMPORTANT IS WHEN YOU 4268 02:57:45,480 --> 02:57:48,600 LOOK WITH THE CAR T, THERE IS NO 4269 02:57:48,600 --> 02:57:50,240 CYTOKINE RELEASE. 4270 02:57:50,240 --> 02:57:53,960 WITH EITHER THE CD33 CAR T OR 4271 02:57:53,960 --> 02:57:56,720 WITH THE UNTRANSDUCED CONTROL. 4272 02:57:56,720 --> 02:58:00,080 SO IF WE'RE GOING TO DO A STUDY, 4273 02:58:00,080 --> 02:58:01,160 A SCREENING STUDY, TO EVALUATE 4274 02:58:01,160 --> 02:58:03,560 ONE OF THESE, THE FIRST THING WE 4275 02:58:03,560 --> 02:58:05,040 HAVE TO DO IS PILOT WORK. 4276 02:58:05,040 --> 02:58:07,640 IN THE PILOT WORK WE WOULD BE 4277 02:58:07,640 --> 02:58:10,400 DOING CO-CULTURES OF THE CAR T 4278 02:58:10,400 --> 02:58:11,920 OR NEGATIVE CONTROL WITH 4279 02:58:11,920 --> 02:58:14,720 POSITIVE AND NEGATIVE CONTROL 4280 02:58:14,720 --> 02:58:19,040 CELLS TO WHETHER OR NOT THE T 4281 02:58:19,040 --> 02:58:22,640 CELL CAN KILL POSITIVE CONTROL 4282 02:58:22,640 --> 02:58:26,800 CELLS BEFORE WE SCREEN. 4283 02:58:26,800 --> 02:58:28,320 WE MIGHT INCLUDE RATIOS, HAVE TO 4284 02:58:28,320 --> 02:58:31,600 CONFIRM WHETHER OR NOT ANY 4285 02:58:31,600 --> 02:58:33,360 REPORTER GENES ARE BEING 4286 02:58:33,360 --> 02:58:35,440 EXPRESSED IN OUR HANDS, WHETHER 4287 02:58:35,440 --> 02:58:36,560 THE TARGET EPITOPE IS EXPRESSED 4288 02:58:36,560 --> 02:58:37,320 IN OUR HANDS. 4289 02:58:37,320 --> 02:58:40,160 WE ALSO HAVE TO LOOK AT PLATE 4290 02:58:40,160 --> 02:58:41,600 BINDING KINETICS OF THOSE 4291 02:58:41,600 --> 02:58:43,400 CONTROL CELLS IF THEIR ADHERENT. 4292 02:58:43,400 --> 02:58:46,400 A LOT OF TIMES IF YOU LOOK AT 4293 02:58:46,400 --> 02:58:47,840 CO-CULTURES, ASSAYS, YOU'LL PUT 4294 02:58:47,840 --> 02:58:49,360 YOUR CONTROL CELLS DOWN IN A 4295 02:58:49,360 --> 02:58:51,120 WELL, WAIT FOR AN HOUR, AND PUT 4296 02:58:51,120 --> 02:58:54,160 THE CAR Ts IN. 4297 02:58:54,160 --> 02:58:56,080 FOR OUR CONTINUOUS MONITORING 4298 02:58:56,080 --> 02:58:57,120 IMPEDANCE MONITORING TO WORK 4299 02:58:57,120 --> 02:59:00,200 THEY NEED TO START AS CONFLUENT 4300 02:59:00,200 --> 02:59:00,480 MONOLAYER. 4301 02:59:00,480 --> 02:59:02,800 WE NEED TO UNDERSTAND WHAT THE 4302 02:59:02,800 --> 02:59:03,800 PLATE BINDING KINETICS LOOK LIKE 4303 02:59:03,800 --> 02:59:05,680 AND AS WE'VE COME TO LEARN, AS 4304 02:59:05,680 --> 02:59:09,720 WE WORKED OUR WAY THROUGH THESE 4305 02:59:09,720 --> 02:59:10,800 DIFFERENT hIPSC DERIVED CELL 4306 02:59:10,800 --> 02:59:12,640 TYPES EVERY CELL TYPE HAS ITS 4307 02:59:12,640 --> 02:59:15,200 OWN BINDING KINETICS. 4308 02:59:15,200 --> 02:59:17,400 THEY ALL LOOK COMPLETELY 4309 02:59:17,400 --> 02:59:17,640 DIFFERENT. 4310 02:59:17,640 --> 02:59:20,360 THEN WE NEED TO DO A COUPLE 4311 02:59:20,360 --> 02:59:26,560 PILOT CO-CULTURE STUDIES TO MAKE 4312 02:59:26,560 --> 02:59:27,640 SURE THE IMPEDANCE, CYTOKINE 4313 02:59:27,640 --> 02:59:30,880 RELEASE AND ASSAYS WERE LOOKING 4314 02:59:30,880 --> 02:59:32,640 GOOD, LOOKING AT TARGET CELLS, 4315 02:59:32,640 --> 02:59:34,800 EFFECTOR CELLS, YOU NEED TO KNOW 4316 02:59:34,800 --> 02:59:36,200 IF YOU HAVE SPONTANEOUS LDH 4317 02:59:36,200 --> 02:59:40,120 RELEASE OR SOMETHING LIKE THAT. 4318 02:59:40,120 --> 02:59:41,480 CO-CULTURE WITH AN UNTRANSDUCED 4319 02:59:41,480 --> 02:59:44,960 OR T CELL THAT'S TRANSDUCED WITH 4320 02:59:44,960 --> 02:59:46,600 RELEVANT CAR, POSITIVE CONTROL 4321 02:59:46,600 --> 02:59:47,440 CELLS WHICH OF COURSE NEED TO 4322 02:59:47,440 --> 02:59:50,000 DIE EVERY TIME DO YOU A 4323 02:59:50,000 --> 02:59:52,040 CO-CULTURE EXPERIMENT TO SHOW 4324 02:59:52,040 --> 02:59:53,320 YOUR ASSAY IS WORKING, NEGATIVE 4325 02:59:53,320 --> 02:59:54,360 CONTROL CELLS THAT NEED TO NOT 4326 02:59:54,360 --> 02:59:56,440 DIE WHEN YOU DO YOUR EXPERIMENT 4327 02:59:56,440 --> 03:00:03,120 TO MAKE SURE YOU'VE GOT 4328 03:00:03,120 --> 03:00:05,520 SPECIFICITIES, MEDIAN ONLY, 4329 03:00:05,520 --> 03:00:07,360 TOTAL LYSIS CONTROL. 4330 03:00:07,360 --> 03:00:08,360 OPTIMIZATION WOULD HAPPEN DURING 4331 03:00:08,360 --> 03:00:09,800 THE PILOT WORK. 4332 03:00:09,800 --> 03:00:12,080 AFTER PILOT WORK GETS DONE, WE 4333 03:00:12,080 --> 03:00:15,840 WOULD GO INTO THE MAIN SCREEN. 4334 03:00:15,840 --> 03:00:18,240 WE WOULD PUT THESE PLATES INSIDE 4335 03:00:18,240 --> 03:00:20,760 OF THESE CONTINUOUS IMPEDANCE 4336 03:00:20,760 --> 03:00:23,040 MONITORING MACHINES. 4337 03:00:23,040 --> 03:00:24,400 WE ACTUALLY JUST GOT DELIVERED 4338 03:00:24,400 --> 03:00:26,000 SOME NEW ONES, SO WE'RE GOING 4339 03:00:26,000 --> 03:00:29,520 FROM CAPACITY OF TWO PLATES TO 4340 03:00:29,520 --> 03:00:29,840 TEN. 4341 03:00:29,840 --> 03:00:33,240 OUR LOGISTICS WOULD LOOK LIKE 4342 03:00:33,240 --> 03:00:33,520 THIS. 4343 03:00:33,520 --> 03:00:44,080 THERE'S A STAGGERED START. THEY 4344 03:00:44,920 --> 03:00:46,360 NEED TO CULTURE FOR THE SAME 4345 03:00:46,360 --> 03:00:48,160 TIME, THE IDEA IS START IN 4346 03:00:48,160 --> 03:00:49,920 STAGGERED WAY BECAUSE PLATING IS 4347 03:00:49,920 --> 03:00:52,120 DIFFICULT. 4348 03:00:52,120 --> 03:00:55,000 AND ESTABLISH THE CO-CULTURES. 4349 03:00:55,000 --> 03:00:56,400 SO YOU'RE NOT THAWING PRECIOUS 4350 03:00:56,400 --> 03:00:58,200 SAMPLES OF T CELLS OVER AND OVER 4351 03:00:58,200 --> 03:00:58,560 AGAIN. 4352 03:00:58,560 --> 03:01:00,840 AND AS I SAID BEFORE WE WOULD 4353 03:01:00,840 --> 03:01:03,040 WATCH THEM OVER ABOUT 72 HOURS 4354 03:01:03,040 --> 03:01:04,640 AND END THE EXPERIMENT. 4355 03:01:04,640 --> 03:01:07,600 THIS IS WHAT LOGISTICS LOOKS 4356 03:01:07,600 --> 03:01:08,600 LIKE. 4357 03:01:08,600 --> 03:01:10,800 AND THEN TOTAL STUDY PLANS, WE 4358 03:01:10,800 --> 03:01:12,240 WOULD START WITH PILOT STUDY AND 4359 03:01:12,240 --> 03:01:13,640 IF OF COURSE LOOKS GOOD AND 4360 03:01:13,640 --> 03:01:15,120 WE'VE GOT EVERYTHING TWEAKED AND 4361 03:01:15,120 --> 03:01:17,560 OPTIMIZED AND GO INTO THE MAIN 4362 03:01:17,560 --> 03:01:19,200 STUDY, PRIMARY SCREEN, WHICH 4363 03:01:19,200 --> 03:01:26,080 WOULD HAVE LOW LOGISTICS LIKE E 4364 03:01:26,080 --> 03:01:27,680 PREVIOUS SLIDE, IMPEDANCE, 4365 03:01:27,680 --> 03:01:29,200 CONTINUOUS MONITORING, COMPANION 4366 03:01:29,200 --> 03:01:31,760 TIE SO TOXICITY ASSAY OF SOME 4367 03:01:31,760 --> 03:01:33,600 KIND, SOME AMOUNT OF IMAGING TO 4368 03:01:33,600 --> 03:01:35,160 MAKE SURE WHAT WE'RE READING OUT 4369 03:01:35,160 --> 03:01:37,680 IS WHAT WE'RE SEEING WITH OUR 4370 03:01:37,680 --> 03:01:39,240 EYES. 4371 03:01:39,240 --> 03:01:41,040 AND THEN ALSO CYTOKINE RELEASE 4372 03:01:41,040 --> 03:01:41,240 ASSAY. 4373 03:01:41,240 --> 03:01:43,160 IF YOU HAVE AN UNEXPECTED HIT 4374 03:01:43,160 --> 03:01:44,280 SOMEWHERE THEN YOU NEED TO GO 4375 03:01:44,280 --> 03:01:45,720 THAT CELL TYPE AND SAY, WELL, 4376 03:01:45,720 --> 03:01:47,240 DOES THE CELL TYPE HAVE THE 4377 03:01:47,240 --> 03:01:47,480 TARGET? 4378 03:01:47,480 --> 03:01:51,360 CAN YOU FOLLOW THAT UP WITH 4379 03:01:51,360 --> 03:01:55,440 WESTERN BLOTS, FLOW CYTOMETRY OR 4380 03:01:55,440 --> 03:01:57,720 IHC TO SEE IF THE TARGET IS 4381 03:01:57,720 --> 03:02:01,800 EXPRESSED, FOLLOWED WITH 4382 03:02:01,800 --> 03:02:03,000 ADDITIONAL CO-CULTURES TO TEASE 4383 03:02:03,000 --> 03:02:04,520 OUT SENSITIVITY AND TIMING. 4384 03:02:04,520 --> 03:02:07,600 THE THING THAT'S IMPORTANT, 4385 03:02:07,600 --> 03:02:13,480 WE'RE COMING AT THIS BINDING 4386 03:02:13,480 --> 03:02:15,040 THING, WITH ORTHOGONAL DATASETS 4387 03:02:15,040 --> 03:02:18,640 WITH A WEIGHT OF EVIDENCE 4388 03:02:18,640 --> 03:02:19,360 APPROACH. 4389 03:02:19,360 --> 03:02:22,720 AND THAT REGULATORS LIKE TO SEE 4390 03:02:22,720 --> 03:02:23,240 THAT. 4391 03:02:23,240 --> 03:02:24,520 SO, AS FAR AS QUESTIONS AND 4392 03:02:24,520 --> 03:02:25,160 CONSIDERATIONS THAT PEOPLE NEED 4393 03:02:25,160 --> 03:02:27,880 TO THINK ABOUT BEFORE THEY DO 4394 03:02:27,880 --> 03:02:29,920 THIS STUDY, IF A STUDY IS COMING 4395 03:02:29,920 --> 03:02:33,160 TO US, WE DO HAVE TO GET 4396 03:02:33,160 --> 03:02:34,360 APPROVAL BY OUR BIOSAFETY 4397 03:02:34,360 --> 03:02:35,400 COMMITTEE SO THERE IS A CERTAIN 4398 03:02:35,400 --> 03:02:36,800 AMOUNT OF INFORMATION THAT NEEDS 4399 03:02:36,800 --> 03:02:40,040 TO BE SHARED, LIKE WHAT IS THE 4400 03:02:40,040 --> 03:02:41,960 LENTIVIRUS OR WHAT TYPE OF 4401 03:02:41,960 --> 03:02:43,400 VECTOR ARE YOU USING TO EXPRESS 4402 03:02:43,400 --> 03:02:44,680 THE CAR, INFORMATION ABOUT THE 4403 03:02:44,680 --> 03:02:46,440 CELL TYPES, THAT KIND OF THING. 4404 03:02:46,440 --> 03:02:48,080 WE WOULD NEED INFORMATION LIKE 4405 03:02:48,080 --> 03:02:48,280 THAT. 4406 03:02:48,280 --> 03:02:50,360 IF THERE'S ALREADY AN 4407 03:02:50,360 --> 03:02:51,480 ESTABLISHED KILLING ASSAY FOR 4408 03:02:51,480 --> 03:02:53,240 CONTROL CELLS, IT'S NICE TO 4409 03:02:53,240 --> 03:02:55,640 SHARE IT BECAUSE THAT PROVIDES 4410 03:02:55,640 --> 03:02:58,320 US WITH A SPRINGBOARD FOR ASSAY 4411 03:02:58,320 --> 03:02:58,800 OPTIMIZATION. 4412 03:02:58,800 --> 03:02:59,560 AND OTHER CONSIDERATIONS THAT 4413 03:02:59,560 --> 03:03:01,440 MIGHT BE SPECIFIC TO THAT 4414 03:03:01,440 --> 03:03:03,360 PARTICULAR CAR T. 4415 03:03:03,360 --> 03:03:06,960 SO, JUST SO EVERYBODY 4416 03:03:06,960 --> 03:03:10,240 UNDERSTANDS, OUR GROUP CURRENTLY 4417 03:03:10,240 --> 03:03:11,680 FUNDS -- CURRENTLY SUPPORTS THE 4418 03:03:11,680 --> 03:03:14,640 NEXT PROGRAMS, WHICH IS THIS 4419 03:03:14,640 --> 03:03:17,280 BULLET POINT DOWN HERE, NEXT 4420 03:03:17,280 --> 03:03:19,800 PROVIDES RESOURCES BUT NOT MONEY 4421 03:03:19,800 --> 03:03:20,800 FOR APPROVED SIZES, PEOPLE APPLY 4422 03:03:20,800 --> 03:03:22,680 TO BE IN THAT PROGRAM. 4423 03:03:22,680 --> 03:03:30,080 AND THEN NCI ALSO HAS THIS OTHER 4424 03:03:30,080 --> 03:03:31,520 CONSULTATION AS MUCH AS THAT'S 4425 03:03:31,520 --> 03:03:32,280 AVAILABLE IF ANYBODY WANTS TO 4426 03:03:32,280 --> 03:03:33,480 SEE IT. 4427 03:03:33,480 --> 03:03:43,800 AND THAT IS THE END. 4428 03:03:45,480 --> 03:03:46,520 >> THAT WAS GREAT. 4429 03:03:46,520 --> 03:03:48,400 THERE'S A QUESTION ONLINE. 4430 03:03:48,400 --> 03:03:52,320 I'M GOING TO TAKE PRIORITY AND 4431 03:03:52,320 --> 03:03:54,200 GIVE MYSELF PRIORITY. 4432 03:03:54,200 --> 03:03:54,840 [LAUGHTER] 4433 03:03:54,840 --> 03:03:56,160 THAT CAME OUT WRONG. 4434 03:03:56,160 --> 03:03:59,520 I'M JUST CURIOUS ABOUT THE CELL 4435 03:03:59,520 --> 03:03:59,960 SOURCING. 4436 03:03:59,960 --> 03:04:01,920 ARE THESE ALL THE I CELLS FROM 4437 03:04:01,920 --> 03:04:04,360 CDI OR DO YOU HAVE 4438 03:04:04,360 --> 03:04:06,120 DIFFERENTIATION PROTOCOLS YOU'RE 4439 03:04:06,120 --> 03:04:09,080 USING TO TAKE iPSCs AND TAKE 4440 03:04:09,080 --> 03:04:10,600 THEM TO HOMOGENOUS POPULATIONS 4441 03:04:10,600 --> 03:04:12,560 DOWN DIFFERENT LINEAGES AND HOW 4442 03:04:12,560 --> 03:04:18,600 ARE YOU ENSURING LIKE 4443 03:04:18,600 --> 03:04:20,040 HOMOGENEITY OF THE OUTCOME? 4444 03:04:20,040 --> 03:04:22,240 >> WE'RE WORKING WITH FCDI AND 4445 03:04:22,240 --> 03:04:24,280 SO WHEN THOSE CELLS COME TO YOU 4446 03:04:24,280 --> 03:04:26,920 FROM FCDI THEY ARE PARTLY 4447 03:04:26,920 --> 03:04:29,960 DIFFERENTIATE AND YOU'RE 4448 03:04:29,960 --> 03:04:30,480 FINISHING IT OUT. 4449 03:04:30,480 --> 03:04:34,480 SOME CELL TYPES THAT I MENTIONED 4450 03:04:34,480 --> 03:04:38,520 LIKE PNEUMOCYTES, TYPE 1, RENAL 4451 03:04:38,520 --> 03:04:41,800 EPITHELIAL CELLS ARE NOT REALLY 4452 03:04:41,800 --> 03:04:42,560 AVAILABLE IN hIPSC FORMAL, 4453 03:04:42,560 --> 03:04:47,280 THEY WOULD BE MORE LIKE PRIMARY 4454 03:04:47,280 --> 03:04:48,880 CELLS WHICH IS LESS FAVORITE BUT 4455 03:04:48,880 --> 03:04:50,400 I STILL THINK IT'S A GOOD IDEA 4456 03:04:50,400 --> 03:04:52,760 TO LOOK AT THEM FROM A TOX 4457 03:04:52,760 --> 03:04:53,320 PERSPECTIVE. 4458 03:04:53,320 --> 03:04:56,240 >>IN TERMS OF LIKE CO-CULTURE 4459 03:04:56,240 --> 03:04:57,800 CONDITIONS, TO BE ABLE TO 4460 03:04:57,800 --> 03:04:59,040 CULTURE ALL OF THESE DIFFERENT 4461 03:04:59,040 --> 03:05:01,440 CELL TYPES TOGETHER THAT ALL 4462 03:05:01,440 --> 03:05:04,320 HAVE FAIRLY UNIQUE SORT OF NEEDS 4463 03:05:04,320 --> 03:05:06,440 AND REQUIREMENTS HOW ARE YOU 4464 03:05:06,440 --> 03:05:07,280 WORKING THAT OUT? 4465 03:05:07,280 --> 03:05:11,040 >>GOOD QUESTION. 4466 03:05:11,040 --> 03:05:15,520 WE DO EVERYTHING IN 96 WELL 4467 03:05:15,520 --> 03:05:18,920 PLATES, ONE CELL TYPE PER PLATE. 4468 03:05:18,920 --> 03:05:20,040 ONCE YOU'VE GOT ENOUGH REPEATS, 4469 03:05:20,040 --> 03:05:23,880 SO YOU HAVE A DECENT ENOUGH N 4470 03:05:23,880 --> 03:05:25,200 AND ENOUGH CELLS ALONE, THIS 4471 03:05:25,200 --> 03:05:28,000 CELL ALONE, THAT CELL ALONE, 4472 03:05:28,000 --> 03:05:29,240 LYSIS CONTROLS, ET CETERA, IT 4473 03:05:29,240 --> 03:05:32,840 FILLS UP A PLATE OR SOMETIMES 4474 03:05:32,840 --> 03:05:35,560 TWO PLATES REAL FAST. 4475 03:05:35,560 --> 03:05:39,400 YEAH, IT'S PRETTY -- CAN BE 4476 03:05:39,400 --> 03:05:40,680 LABOR INTENSIVE, SO, YEAH. 4477 03:05:40,680 --> 03:05:41,280 >> THANKS. 4478 03:05:41,280 --> 03:05:46,200 WE HAVE AT LEAST ONE QUESTION 4479 03:05:46,200 --> 03:05:46,440 ONLINE. 4480 03:05:46,440 --> 03:05:47,160 >> TWO QUESTIONS. 4481 03:05:47,160 --> 03:05:50,160 FIRST ONE IS MAYBE SOMEWHAT 4482 03:05:50,160 --> 03:05:52,360 RELATED TO NICOLE'S. 4483 03:05:52,360 --> 03:05:54,080 ELLEN BERG, HAVE YOU CONSIDERED 4484 03:05:54,080 --> 03:05:55,840 DOING ASSESSMENTS ON HUMAN 4485 03:05:55,840 --> 03:06:04,040 PRIMARY CELLS, IN ADDITION TO 4486 03:06:04,040 --> 03:06:05,880 iPSC DERIVED CELLS, 4487 03:06:05,880 --> 03:06:09,960 DIFFERENTIATED LONG AND 4488 03:06:09,960 --> 03:06:12,600 EXPENSESSIVE, PRIMARY CELLS MAY 4489 03:06:12,600 --> 03:06:18,520 CAPTURE MORE ADULT-LIKE 4490 03:06:18,520 --> 03:06:18,800 PHENOTYPES. 4491 03:06:18,800 --> 03:06:20,760 >> YES, WE LIKE CDFI CELLS 4492 03:06:20,760 --> 03:06:22,960 BECAUSE THEY ARE SO WELL 4493 03:06:22,960 --> 03:06:24,520 CHARACTERIZED, AND AS I SAID 4494 03:06:24,520 --> 03:06:28,120 WHEN YOU BUY THEM, THEY COME 4495 03:06:28,120 --> 03:06:29,840 ALREADY PART WAY DONE, IF YOU 4496 03:06:29,840 --> 03:06:33,160 WILL, SO YOU'RE FINISHING IT AND 4497 03:06:33,160 --> 03:06:35,760 NOT HAVING TO SPEND WEEKS OR 4498 03:06:35,760 --> 03:06:40,680 MONTHS OR YEARS OPTIMIZING A 4499 03:06:40,680 --> 03:06:41,880 MATURATION PROTOCOL. 4500 03:06:41,880 --> 03:06:44,080 AND, YES, I AGREE ABOUT PRIMARY 4501 03:06:44,080 --> 03:06:44,320 CELLS. 4502 03:06:44,320 --> 03:06:45,920 AS I SAID, IF WE COULD GET ALL 4503 03:06:45,920 --> 03:06:49,040 OF THE CELL TYPES THAT I WANT 4504 03:06:49,040 --> 03:06:52,400 FROM FCDI NICE AND NEAT THAT 4505 03:06:52,400 --> 03:06:53,600 WOULD BE GREAT BUT SINCE THEY 4506 03:06:53,600 --> 03:06:56,240 ARE NOT AVAILABLE RIGHT NOW I'M 4507 03:06:56,240 --> 03:06:57,960 WILLING AND INTERESTED TO GO OUT 4508 03:06:57,960 --> 03:07:02,240 INTO THE PRIMARY REALM AS WELL. 4509 03:07:02,240 --> 03:07:06,760 I GOT MY START IN PRIMARY 4510 03:07:06,760 --> 03:07:07,240 EPITHELIAL CELLS ANYWAY. 4511 03:07:07,240 --> 03:07:14,240 >> APRIL KNOB HAS A QUESTION, 4512 03:07:14,240 --> 03:07:16,640 HOW DID REGULATORS REACT TO IND 4513 03:07:16,640 --> 03:07:18,720 AS ONLY SAFETY DATA, WAS THERE A 4514 03:07:18,720 --> 03:07:22,560 HIGH DEGREE OF SCRUTINY OR 4515 03:07:22,560 --> 03:07:23,320 EXTENSIVE QUALIFICATION. 4516 03:07:23,320 --> 03:07:25,920 >> THAT WAS FROM THE FRY GROUP, 4517 03:07:25,920 --> 03:07:31,240 CD33, BEFORE MY TIME HERE, BUT 4518 03:07:31,240 --> 03:07:33,800 THEY DID TAKE THE CD33 CAR T 4519 03:07:33,800 --> 03:07:34,800 FORWARD INTO HUMANS, SO I HAVE 4520 03:07:34,800 --> 03:07:37,120 TO BELIEVE THAT IF THERE WAS ANY 4521 03:07:37,120 --> 03:07:38,120 PUSHBACK THAT IT PROBABLY WASN'T 4522 03:07:38,120 --> 03:07:42,600 TERRIBLE AND IF THEY HAD ANY 4523 03:07:42,600 --> 03:07:44,000 THEY GOT THROUGH IT. 4524 03:07:44,000 --> 03:07:48,400 THAT'S AS FAR AS I KNOW, CD33 4525 03:07:48,400 --> 03:07:52,320 CAR T IS STILL MAKING ITS WAY 4526 03:07:52,320 --> 03:07:52,800 THROUGH THE PIPELINE. 4527 03:07:52,800 --> 03:07:56,360 >> MULTIPLE CAR T PROJECTS HAVE 4528 03:07:56,360 --> 03:07:58,440 BEEN APPROVED. 4529 03:07:58,440 --> 03:08:01,400 >> THERE HAVE BEEN MULTIPLE CAR 4530 03:08:01,400 --> 03:08:03,480 T PRODUCTS THAT HAVE BEEN 4531 03:08:03,480 --> 03:08:06,760 APPROVED IN THIS MANNER, SO ... 4532 03:08:06,760 --> 03:08:09,480 >> THANK YOU. 4533 03:08:09,480 --> 03:08:12,680 4534 03:08:12,680 --> 03:08:19,240 >> THANK YOU SO MUCH. 4535 03:08:19,240 --> 03:08:23,440 NOW FOR OUR LAST PRESENTATION OF 4536 03:08:23,440 --> 03:08:27,360 THE AFTERNOON, FROM THE NICEATM 4537 03:08:27,360 --> 03:08:28,800 GROUP, KAMEL MANSOURI IS GOING 4538 03:08:28,800 --> 03:08:31,120 TO TALK ABOUT SOME NICEATM 4539 03:08:31,120 --> 03:08:31,880 COMPUTATIONAL RESOURCES AND 4540 03:08:31,880 --> 03:08:34,600 TOOLS WE'VE BEEN DEVELOPING 4541 03:08:34,600 --> 03:08:39,080 UNDER INTEGRATED CHEMICAL 4542 03:08:39,080 --> 03:08:40,520 ENVIRONMENT AND OPPERA. 4543 03:08:40,520 --> 03:08:41,360 >> THANKS, NICOLE. 4544 03:08:41,360 --> 03:08:44,880 THANKS, EVERYONE, FOR BEING 4545 03:08:44,880 --> 03:08:46,520 HERE, ALSO ONLINE WITH US THIS 4546 03:08:46,520 --> 03:08:47,720 AFTERNOON. 4547 03:08:47,720 --> 03:08:51,360 I'LL BE TALKING ABOUT THE 4548 03:08:51,360 --> 03:08:53,640 NICEATM COMPUTATIONAL TOOLS, AND 4549 03:08:53,640 --> 03:08:59,080 I WILL START WITH ICE, WHICH 4550 03:08:59,080 --> 03:09:04,360 IS -- WELL, LET'S SEE. 4551 03:09:04,360 --> 03:09:08,320 THIS IS ONLINE, RIGHT? 4552 03:09:08,320 --> 03:09:13,880 SO, I DON'T SEE MY LITTLE NOTES. 4553 03:09:13,880 --> 03:09:17,800 SO, ICE IS A FREE AND PUBLIC 4554 03:09:17,800 --> 03:09:19,480 ONLINE RESOURCE FOR HIGHLY 4555 03:09:19,480 --> 03:09:21,000 CURATED DATA, AND IT ALSO 4556 03:09:21,000 --> 03:09:24,280 PROVIDES A LOT OF COMPUTATIONAL 4557 03:09:24,280 --> 03:09:26,640 TOOLS FOR EXPLORING THAT DATA AS 4558 03:09:26,640 --> 03:09:30,680 WELL AS DOING A LITTLE BIT OF 4559 03:09:30,680 --> 03:09:32,240 UTILIZATION AND ANALYSIS AS 4560 03:09:32,240 --> 03:09:32,560 WELL. 4561 03:09:32,560 --> 03:09:37,040 AS YOU CAN SEE HERE, THESE ARE 4562 03:09:37,040 --> 03:09:39,000 THE DIFFERENT TOOLS THAT WHEN 4563 03:09:39,000 --> 03:09:41,520 YOU GO ONLINE ON THE ICE 4564 03:09:41,520 --> 03:09:42,840 WEBSITE, THIS IS WHAT WE'RE 4565 03:09:42,840 --> 03:09:45,960 GOING TO SEE. 4566 03:09:45,960 --> 03:09:48,200 YOU CAN CHOOSE ONE OF THESE 4567 03:09:48,200 --> 03:09:50,200 TOOLS TO PERFORM LIKE DIFFERENT 4568 03:09:50,200 --> 03:09:53,440 SEARCHES ON THE DATABASE, AS 4569 03:09:53,440 --> 03:09:55,080 WELL AS DOING THE ANALYSIS, 4570 03:09:55,080 --> 03:10:00,480 EXPLORATION OF THE DATA AS WELL 4571 03:10:00,480 --> 03:10:04,120 AS SEARCHING THE DIFFERENT 4572 03:10:04,120 --> 03:10:06,160 HIGHLY CURATED IN VIVO, IN 4573 03:10:06,160 --> 03:10:12,520 VITRO, AND IN SILICO 4574 03:10:12,520 --> 03:10:14,280 PREDICTIONS, AND RUNNING PBK 4575 03:10:14,280 --> 03:10:17,880 MODELS, I'LL TALK ABOUT THAT 4576 03:10:17,880 --> 03:10:18,320 LATER. 4577 03:10:18,320 --> 03:10:21,520 THE DIFFERENT TOOLS THAT YOU 4578 03:10:21,520 --> 03:10:25,280 HAVE ON ICE, FOR EXAMPLE, 4579 03:10:25,280 --> 03:10:27,400 EXPLORATION OF THE DATA COMING 4580 03:10:27,400 --> 03:10:31,440 FROM THE TOX CAST AND TOX21, YOU 4581 03:10:31,440 --> 03:10:41,400 CAN DO SOME CHEMICAL SIMILARITY 4582 03:10:41,400 --> 03:10:44,560 ANALYSIS AND THE LIKE 4583 03:10:44,560 --> 03:10:45,920 VISUALIZATION USING DIFFERENT 4584 03:10:45,920 --> 03:10:50,040 CURVE FITTING TOOLS THAT YOU 4585 03:10:50,040 --> 03:10:53,960 HAVE AVAILABLE, AS WELL AS 4586 03:10:53,960 --> 03:10:55,360 EXPLORING THE CHEMICAL EXPOSURE 4587 03:10:55,360 --> 03:10:59,000 AND USE DATASETS THAT YOU HAVE 4588 03:10:59,000 --> 03:11:03,160 ON ICE THAT ARE HIGHLY CURATED, 4589 03:11:03,160 --> 03:11:06,240 COMING FROM DIFFERENT SOURCES 4590 03:11:06,240 --> 03:11:07,920 LIKE EPA AND OTHER AGENCIES. 4591 03:11:07,920 --> 03:11:16,560 YOU CAN ALSO DO LIKE PREDICTING 4592 03:11:16,560 --> 03:11:21,600 TISSUE CONCENTRATION, SO ICE IS 4593 03:11:21,600 --> 03:11:23,000 ALWAYS BEING UPDATED. 4594 03:11:23,000 --> 03:11:25,200 ONLY THE DATASETS THEMSELVES 4595 03:11:25,200 --> 03:11:29,600 THAT EXIST ARE USUALLY CURATED 4596 03:11:29,600 --> 03:11:33,840 AND RECURATED AND DATA IS BEING 4597 03:11:33,840 --> 03:11:35,720 ADDED CONTINUOUSLY, BUT ALSO THE 4598 03:11:35,720 --> 03:11:39,040 FEATURES THAT ARE PROVIDED ON 4599 03:11:39,040 --> 03:11:41,320 ICE ARE ALSO USUALLY UPDATED. 4600 03:11:41,320 --> 03:11:43,920 AND SOME OF THE LATEST FEATURES 4601 03:11:43,920 --> 03:11:49,080 THAT YOU CAN FIND IN THE LATEST 4602 03:11:49,080 --> 03:11:51,720 VERSION 4.0, AND ICE, ARE FOR 4603 03:11:51,720 --> 03:11:55,560 EXAMPLE THE PBK AND IVE THOLES 4604 03:11:55,560 --> 03:11:59,920 HAVE ENHANCEMENTS AND NEW MODELS 4605 03:11:59,920 --> 03:12:02,640 LIKE GESTATIONAL MODEL THAT WAS 4606 03:12:02,640 --> 03:12:06,480 IMPLEMENTED FROM THE EPA STTK 4607 03:12:06,480 --> 03:12:06,920 PACKAGE. 4608 03:12:06,920 --> 03:12:11,040 AND A FEW OTHER ENHANCEMENTS 4609 03:12:11,040 --> 03:12:13,360 LIKE POSSIBILITY NOW TO LIKE 4610 03:12:13,360 --> 03:12:15,320 SELECT IN DIFFERENT UNITS ON 4611 03:12:15,320 --> 03:12:17,280 THOSE MODELS. 4612 03:12:17,280 --> 03:12:18,760 THE EXPOSURE PREDICTIONS ARE 4613 03:12:18,760 --> 03:12:25,120 ALSO NEW ADDITION TO ICE, LIKE 4614 03:12:25,120 --> 03:12:28,040 THE EPA'S SEEM3, EVALUATION OF 4615 03:12:28,040 --> 03:12:30,920 MODELS, AND SEVERAL OTHER 4616 03:12:30,920 --> 03:12:33,760 EXPOSURE PREDICTIONS ARE NOW 4617 03:12:33,760 --> 03:12:36,560 ACCESSIBLE THROUGH THE ICE 4618 03:12:36,560 --> 03:12:37,480 SEARCH DATABASE. 4619 03:12:37,480 --> 03:12:41,840 ON THE ICE INTERFACE AS WELL AS 4620 03:12:41,840 --> 03:12:44,160 THROUGH THE API, REST API, THAT 4621 03:12:44,160 --> 03:12:49,400 YOU CAN EMBED TO YOUR OWN 4622 03:12:49,400 --> 03:12:51,600 SCRIPTS OR TOOLS FOR AUTOMATIC 4623 03:12:51,600 --> 03:12:52,920 SEARCHING AND DOWNLOADING OF 4624 03:12:52,920 --> 03:12:53,160 DATA. 4625 03:12:53,160 --> 03:12:57,640 IN BETA VERSION NOW WE HAVE A 4626 03:12:57,640 --> 03:12:59,720 COMPLETELY REDESIGNED SEARCH 4627 03:12:59,720 --> 03:13:02,440 INTERFACE, THAT PROVIDES NEW 4628 03:13:02,440 --> 03:13:06,280 UTILIZATION OPTIONS, AND LAST 4629 03:13:06,280 --> 03:13:13,680 BUT NOT LEAST THE CHEMICAL NAME 4630 03:13:13,680 --> 03:13:16,440 SEARCH, BEFORE WE HAD 4631 03:13:16,440 --> 03:13:18,200 IDENTIFIERS, BUT WE KNOW CERTAIN 4632 03:13:18,200 --> 03:13:20,640 CHEMICALS HAVE DIFFERENT 4633 03:13:20,640 --> 03:13:23,080 IDENTIFIERS, ALSO HAVE DIFFERENT 4634 03:13:23,080 --> 03:13:26,080 SYNONYMS, SO IN COLLABORATION 4635 03:13:26,080 --> 03:13:28,480 WITH EPA WE HAVE NOW THE 4636 03:13:28,480 --> 03:13:30,680 POSSIBILITY TO SEARCH CHEMICALS 4637 03:13:30,680 --> 03:13:32,400 USING THEIR SYNONYMS. 4638 03:13:32,400 --> 03:13:37,760 AND THAT'S ALSO IMPLEMENTED IN 4639 03:13:37,760 --> 03:13:40,760 THE ICE REST API. 4640 03:13:40,760 --> 03:13:42,120 SO, FOR THE GESTATIONAL MODEL ON 4641 03:13:42,120 --> 03:13:48,160 ICE IT'S ONE OF THE MODELS, BBK 4642 03:13:48,160 --> 03:13:51,040 MODELS IN ADDITION TO OTHER 4643 03:13:51,040 --> 03:13:54,600 COMING FROM THE SDDK IMPLEMENTED 4644 03:13:54,600 --> 03:14:00,520 NOW USING THE -- IN A MORE USER 4645 03:14:00,520 --> 03:14:03,920 FRIENDLY WAY, ON ICE, KNEEING IT 4646 03:14:03,920 --> 03:14:07,200 REQUIRES A LITTLE BIT OF 4647 03:14:07,200 --> 03:14:10,480 KNOWLEDGE AND SCRIPTING IN R OR 4648 03:14:10,480 --> 03:14:14,240 OTHER LANGUAGES BUT ON ICE YOU 4649 03:14:14,240 --> 03:14:18,280 CAN RUN IT WITHOUT HAVING TO 4650 03:14:18,280 --> 03:14:21,240 WRITE ANY CODE THROUGH ITS USER 4651 03:14:21,240 --> 03:14:23,200 FRIENDLY INTERFACE. 4652 03:14:23,200 --> 03:14:25,720 SO THE RESULTS CAN BE VISUALIZED 4653 03:14:25,720 --> 03:14:29,680 ALSO ON THE ICE DASHBOARD, AND 4654 03:14:29,680 --> 03:14:34,920 YOU HAVE LIKE DIFFERENT 4655 03:14:34,920 --> 03:14:37,000 FILTERING OPTIONS TO SELECT 4656 03:14:37,000 --> 03:14:38,120 COMPARTMENTS AND DIFFERENT 4657 03:14:38,120 --> 03:14:40,320 PLOTTING OPTIONS AS WELL. 4658 03:14:40,320 --> 03:14:43,720 SO, LIKE I SAID THROUGH THE NEW 4659 03:14:43,720 --> 03:14:49,520 GESTATIONAL MODEL YOU CAN DO 4660 03:14:49,520 --> 03:14:54,400 IVIVE AND PREDICT THE MATERNAL 4661 03:14:54,400 --> 03:14:56,200 OR FETAL EADs, EQUIVALENT 4662 03:14:56,200 --> 03:14:58,440 ADMINISTERED DOSE FOR MULTIPLE 4663 03:14:58,440 --> 03:15:01,720 CHEMICALS, NOT JUST FOR ONE 4664 03:15:01,720 --> 03:15:03,080 CHEMICAL. 4665 03:15:03,080 --> 03:15:08,960 YOU HAVE THE EXPOSURE OVERLAY 4666 03:15:08,960 --> 03:15:12,160 TOOL IN AN IVIVE JUST ADDED IN 4667 03:15:12,160 --> 03:15:18,720 ICE 4.0, YOU HAVE THIS OVERLAY 4668 03:15:18,720 --> 03:15:20,760 OPTION FOR POPULATION LEVEL 4669 03:15:20,760 --> 03:15:24,000 EXPOSURE PREDICTION DERIVED FROM 4670 03:15:24,000 --> 03:15:27,240 THE SEEM34 MODEL, COMING FROM 4671 03:15:27,240 --> 03:15:33,320 SDK, YOU CAN RUN COMPARISONS AND 4672 03:15:33,320 --> 03:15:39,200 ANALYSIS AND VISUALIZATION OF 4673 03:15:39,200 --> 03:15:41,880 THE RESULTS. 4674 03:15:41,880 --> 03:15:45,440 AND THIS IS THE NEW SEARCH 4675 03:15:45,440 --> 03:15:47,360 INTERFACE THAT WAS UPDATED. 4676 03:15:47,360 --> 03:15:51,000 IT'S STILL IN BETA VERSION. 4677 03:15:51,000 --> 03:15:53,200 WE'RE STILL WORKING ON LIKE 4678 03:15:53,200 --> 03:15:56,240 IMPROVING AND ENHANCING IT, BUT 4679 03:15:56,240 --> 03:15:57,600 IT'S INTERACTIVE VISUALIZATION 4680 03:15:57,600 --> 03:15:59,760 TOOL THAT ALLOWS USER TO SCOPE 4681 03:15:59,760 --> 03:16:03,120 AND BREAK DOWN DIFFERENT QUERIES 4682 03:16:03,120 --> 03:16:04,680 AND VISUALIZE LIKE COMPARTMENTS 4683 03:16:04,680 --> 03:16:08,080 OF DATA AND THEIR INTEGRATION 4684 03:16:08,080 --> 03:16:10,640 WITHIN THE DIFFERENT DATASETS 4685 03:16:10,640 --> 03:16:13,280 AND VISUALIZATION OF THE 4686 03:16:13,280 --> 03:16:15,880 DISTRIBUTION OF DATASETS THAT 4687 03:16:15,880 --> 03:16:18,440 ARE USUALLY USEFUL FOR EXPLORING 4688 03:16:18,440 --> 03:16:19,040 THE DATA. 4689 03:16:19,040 --> 03:16:22,320 AND LIKE I SAID, LAST BUT NOT 4690 03:16:22,320 --> 03:16:25,600 LEAST, THIS IS HOW YOU CAN 4691 03:16:25,600 --> 03:16:32,240 SEARCH FOR CHEMICALS USING THEIR 4692 03:16:32,240 --> 03:16:36,840 SYNONYMS INSTEAD OF USING 4693 03:16:36,840 --> 03:16:40,040 I.D.s, YOU CAN JUST PUT THE 4694 03:16:40,040 --> 03:16:41,560 SYNONYMS DIRECTLY ON THE 4695 03:16:41,560 --> 03:16:43,520 INTERFACE AND THEN LOOK FOR THEM 4696 03:16:43,520 --> 03:16:48,920 AND THEY WILL BE PULLED OUT BY 4697 03:16:48,920 --> 03:16:49,640 THEIR STRUCTURES. 4698 03:16:49,640 --> 03:16:52,600 THE SECOND PART OF THE 4699 03:16:52,600 --> 03:16:54,920 PRESENTATION IS ABOUT OPERA, THE 4700 03:16:54,920 --> 03:17:01,480 FREE AND OPEN SOURCE SUITE OF 4701 03:17:01,480 --> 03:17:04,120 QSAR MODELS. 4702 03:17:04,120 --> 03:17:06,600 JUST LIKE FIRST DEVELOPED 4703 03:17:06,600 --> 03:17:12,640 INITIALLY AT THE EPA, AND 4704 03:17:12,640 --> 03:17:13,480 CURRENTLY, IT'S MAINLY 4705 03:17:13,480 --> 03:17:15,480 MAINTAINED BY NICEATM BUT STILL 4706 03:17:15,480 --> 03:17:17,760 IN CLOSE COLLABORATION WITH EPA 4707 03:17:17,760 --> 03:17:19,840 AND OTHER AGENCIES. 4708 03:17:19,840 --> 03:17:24,000 SO IT WAS AND STILL ALWAYS BASED 4709 03:17:24,000 --> 03:17:27,520 ON THE FIVE OECD PRINCIPLES FOR 4710 03:17:27,520 --> 03:17:32,520 QSAR MODELING AND VALIDATION, 4711 03:17:32,520 --> 03:17:37,000 CLOSE ATTENTION TO ALGORITHMS WE 4712 03:17:37,000 --> 03:17:40,080 USE, APPLICABILITY, ACCURACY, 4713 03:17:40,080 --> 03:17:43,240 TRANSPARENCY, VALIDATION, AND 4714 03:17:43,240 --> 03:17:44,440 MECHANISTIC INTERPRETATION, 4715 03:17:44,440 --> 03:17:47,520 WHICH IS A VERY IMPORTANT STEP, 4716 03:17:47,520 --> 03:17:50,680 ESPECIALLY WHEN THE QSAR MODELS 4717 03:17:50,680 --> 03:17:54,080 ARE TO BE USED TO SUPPORT 4718 03:17:54,080 --> 03:17:55,080 REGULATORY PURPOSES. 4719 03:17:55,080 --> 03:17:57,720 SO LIKE I SAID, THIS IS LIKE THE 4720 03:17:57,720 --> 03:18:00,120 GENERAL APPROACH FOR OPERA BASED 4721 03:18:00,120 --> 03:18:02,320 ON THE FIVE OECD PRINCIPLES, ALL 4722 03:18:02,320 --> 03:18:08,560 DATA MUST BE HIGHLY CURATED, THE 4723 03:18:08,560 --> 03:18:10,200 SOURCE, CODE SOURCE IS OPEN AND 4724 03:18:10,200 --> 03:18:12,160 FREE AND AVAILABLE ON GITHUB. 4725 03:18:12,160 --> 03:18:13,920 ALL THE ALGORITHMS ARE 4726 03:18:13,920 --> 03:18:17,640 TRANSPARENT AND WE USE THE MOST 4727 03:18:17,640 --> 03:18:19,360 SIMPLE ALGORITHMS POSSIBLE AND 4728 03:18:19,360 --> 03:18:20,800 ONLY INCREASE COMPLEXITY IF THE 4729 03:18:20,800 --> 03:18:23,880 MODEL OR DATA REQUIRES IT. 4730 03:18:23,880 --> 03:18:25,280 THE APPLICABILITY DOMAIN IS WELL 4731 03:18:25,280 --> 03:18:27,120 DEFINED FOR EACH ONE OF THE 4732 03:18:27,120 --> 03:18:29,000 MODELS AND IT DEPENDS ON THE 4733 03:18:29,000 --> 03:18:32,160 MODEL AND THE DATASET SO WE 4734 03:18:32,160 --> 03:18:34,920 DON'T HAVE LIKE 4735 03:18:34,920 --> 03:18:35,880 ONE-SIZE-FITS-ALL APPLICABILITY 4736 03:18:35,880 --> 03:18:36,360 DOMAIN. 4737 03:18:36,360 --> 03:18:39,360 AND THE PREDICTIONS ARE NOT ONLY 4738 03:18:39,360 --> 03:18:42,640 AVAILABLE THROUGH THE 4739 03:18:42,640 --> 03:18:45,840 APPLICATION STAND-ALONE VERSION 4740 03:18:45,840 --> 03:18:46,720 BUT ALSO THROUGH DIFFERENT 4741 03:18:46,720 --> 03:18:48,000 RESOURCES LIKE THE ICE I JUST 4742 03:18:48,000 --> 03:18:50,040 PRESENTED ON IN THE FIRST PART 4743 03:18:50,040 --> 03:18:57,680 OF THE PRESENTATION, BUT ALSO 4744 03:18:57,680 --> 03:18:58,680 EPA'S COMPTOX CHEMICALS 4745 03:18:58,680 --> 03:19:04,720 DASHBOARD, RECENTLY THROUGH THE 4746 03:19:04,720 --> 03:19:05,920 FDA'S PRECISION TOX RESOURCE, 4747 03:19:05,920 --> 03:19:10,160 AND OF COURSE THE STAND-ALONE 4748 03:19:10,160 --> 03:19:11,160 APPLICATION. 4749 03:19:11,160 --> 03:19:13,440 SO IN ITS LATEST VERSION LIKE WE 4750 03:19:13,440 --> 03:19:15,640 DO FOR ICE, OPERA IS ALWAYS 4751 03:19:15,640 --> 03:19:16,000 UPDATED. 4752 03:19:16,000 --> 03:19:19,200 WITH EACH UPDATE WE ADD NEWLY 4753 03:19:19,200 --> 03:19:22,800 CURATED DATASETS TO THE MODELS 4754 03:19:22,800 --> 03:19:25,280 AND UPDATE MODELS. 4755 03:19:25,280 --> 03:19:28,120 AND WE ALSO RETRAIN WHEN IT'S 4756 03:19:28,120 --> 03:19:29,880 NECESSARY, THE MODELS, REALLY 4757 03:19:29,880 --> 03:19:32,200 FIND APPLICABILITY DOMAIN BUT WE 4758 03:19:32,200 --> 03:19:35,280 ALSO ADD NEW MODELS TO THE LIST. 4759 03:19:35,280 --> 03:19:40,840 SO WE RECENTLY UPDATED SOME OF 4760 03:19:40,840 --> 03:19:46,560 THE PHYSCHEM AND ADDED NEW ADME 4761 03:19:46,560 --> 03:19:51,160 PROPERTIES LIKE FRACTION, 4762 03:19:51,160 --> 03:19:53,440 INTRINSIC CLEARANCE, AND CACO2 4763 03:19:53,440 --> 03:19:54,000 PERMEABILITY. 4764 03:19:54,000 --> 03:20:01,440 AND IN ADDITION TO ADDING JUST 4765 03:20:01,440 --> 03:20:03,480 HIGHLY CURATED DATASETS, COMING 4766 03:20:03,480 --> 03:20:08,520 FROM PUBLIC DOMAIN, WE ALSO 4767 03:20:08,520 --> 03:20:10,520 FOCUS ON SPECIFIC CHEMICALS OR 4768 03:20:10,520 --> 03:20:13,320 CLASSES OF CHEMICALS OF HIGH 4769 03:20:13,320 --> 03:20:15,320 IMPORTANCE TO REGULATORS, SINCE 4770 03:20:15,320 --> 03:20:19,000 OPERA WAS FROM DAY 1 DESIGNED TO 4771 03:20:19,000 --> 03:20:21,040 SUPPORT REGULATORY PURPOSES. 4772 03:20:21,040 --> 03:20:26,160 SO, PFAS IS OF COURSE ONE OF 4773 03:20:26,160 --> 03:20:28,440 THOSE CHEMICAL CLASSES, AND IN 4774 03:20:28,440 --> 03:20:30,840 THE LATEST VERSION, ACTUALLY 4775 03:20:30,840 --> 03:20:33,920 THIS ANALYSIS WAS DONE BY AND 4776 03:20:33,920 --> 03:20:35,360 INDEPENDENT LAB, AND IT WAS EVEN 4777 03:20:35,360 --> 03:20:40,600 ON A VERSION PRIOR TO THE LATEST 4778 03:20:40,600 --> 03:20:43,680 VERSION, SO THESE LATEST -- 4779 03:20:43,680 --> 03:20:45,120 THESE ANALYSES ARE COMPARISONS 4780 03:20:45,120 --> 03:20:48,040 WE HOPE ARE EVEN BETTER NOW WITH 4781 03:20:48,040 --> 03:20:50,560 THE LATEST ADDITION OF PFAS BUT 4782 03:20:50,560 --> 03:20:51,880 EVEN IN THE PREVIOUS VERSION AS 4783 03:20:51,880 --> 03:20:55,240 WE CAN SEE HERE THAT OPERA IS 4784 03:20:55,240 --> 03:20:58,440 DOING BETTER THAN OTHER TOOLS 4785 03:20:58,440 --> 03:21:01,960 THAT SOME ARE EVEN COMMERCIAL 4786 03:21:01,960 --> 03:21:06,240 TOOLS, LIKE BETTER ACCURACY FOR 4787 03:21:06,240 --> 03:21:07,320 PFAS CHEMICALS. 4788 03:21:07,320 --> 03:21:09,280 SO LIKE I SAID, OPERA IS 4789 03:21:09,280 --> 03:21:09,960 AVAILABLE ON GITHUB. 4790 03:21:09,960 --> 03:21:14,560 YOU ONLY NEED TO GO TO GITHUB, 4791 03:21:14,560 --> 03:21:17,720 AND THEN SELECT THE LATEST 4792 03:21:17,720 --> 03:21:18,840 RELEASE. 4793 03:21:18,840 --> 03:21:22,680 AND THAT'S HOW YOU GET THE 4794 03:21:22,680 --> 03:21:24,360 LATEST PACKAGE OF OPERA. 4795 03:21:24,360 --> 03:21:29,680 AND IF YOU WANT TO BE ALWAYS 4796 03:21:29,680 --> 03:21:31,600 UPDATED AND KNOW ABOUT THE 4797 03:21:31,600 --> 03:21:33,600 LATEST VERSION, YOU JUST NEED TO 4798 03:21:33,600 --> 03:21:36,120 CLICK WATCH, AND YOU'LL RECEIVE 4799 03:21:36,120 --> 03:21:37,360 NOTIFICATIONS WHENEVER A NEW 4800 03:21:37,360 --> 03:21:39,640 VERSION IS AVAILABLE. 4801 03:21:39,640 --> 03:21:42,240 SO, WHEN YOU GO TO GITHUB, 4802 03:21:42,240 --> 03:21:45,880 YOU'LL HAVE TO SELECT WHICH 4803 03:21:45,880 --> 03:21:47,280 OPTIONS SUITS YOUR NEEDS, 4804 03:21:47,280 --> 03:21:51,000 BECAUSE OPERA IS AVAILABLE IN 4805 03:21:51,000 --> 03:21:53,640 COMMAND LINE VERSION AND HAS 4806 03:21:53,640 --> 03:21:54,720 USER FRIENDLY GRAPHICAL 4807 03:21:54,720 --> 03:21:58,760 INTERFACE, ALSO AVAILABLE FOR 4808 03:21:58,760 --> 03:22:00,240 LINUX AND WINDOWS. 4809 03:22:00,240 --> 03:22:02,720 AND VERSION 3.0 WE'RE PLANNING 4810 03:22:02,720 --> 03:22:05,120 TO HAVE ALSO A VERSION FOR MAC, 4811 03:22:05,120 --> 03:22:08,600 WE STILL DON'T HAVE IT BUT WE 4812 03:22:08,600 --> 03:22:11,040 HAVE ALSO EMBEDDABLE LIBRARIES 4813 03:22:11,040 --> 03:22:16,840 IN DIFFERENT LANGUAGES, SO LIKE 4814 03:22:16,840 --> 03:22:20,240 JAVA, C, C++ THAT YOU CAN EMBED. 4815 03:22:20,240 --> 03:22:24,160 OPERA IS DEVELOPED UNDER THE 4816 03:22:24,160 --> 03:22:26,560 M.I.T. LICENSE, YOU CAN TAKE THE 4817 03:22:26,560 --> 03:22:28,640 CODE AND EMBED IN ANY TOOL, FREE 4818 03:22:28,640 --> 03:22:29,840 OR COMMERCIAL, DOESN'T MATTER. 4819 03:22:29,840 --> 03:22:31,160 YOU HAVE THE FULL RIGHT TO USE 4820 03:22:31,160 --> 03:22:35,400 THE CODE AND USE THE APPLICATION 4821 03:22:35,400 --> 03:22:37,960 IN THE BEST WAY THAT SUITS YOUR 4822 03:22:37,960 --> 03:22:39,920 NEEDS. 4823 03:22:39,920 --> 03:22:42,520 THE INPUT OPTIONS WE ALSO MADE 4824 03:22:42,520 --> 03:22:43,960 IT EASIER TO RUN OPERA. 4825 03:22:43,960 --> 03:22:48,440 SO IF YOU DON'T HAVE THE QSAR 4826 03:22:48,440 --> 03:22:51,520 READY STRUCTURES YOU CAN PUT 4827 03:22:51,520 --> 03:22:54,040 YOUR STRUCTURES, AND OPERA WILL 4828 03:22:54,040 --> 03:22:57,960 STANDARDIZE CHEMICAL STRUCTURES 4829 03:22:57,960 --> 03:22:58,960 TO GET THE QSAR-READY VERSION 4830 03:22:58,960 --> 03:23:00,160 CONSISTENT WITH THE WAY THE 4831 03:23:00,160 --> 03:23:03,360 MODEL WAS TRAINED FOR HIGHEST 4832 03:23:03,360 --> 03:23:03,880 CONSISTENCY AND ACCURACY. 4833 03:23:03,880 --> 03:23:05,560 IF YOU DON'T HAVE THE STRUCTURE 4834 03:23:05,560 --> 03:23:07,320 AT ALL, YOU DON'T HAVE TO LOOK 4835 03:23:07,320 --> 03:23:09,040 SOMEWHERE ELSE. 4836 03:23:09,040 --> 03:23:16,920 YOU JUST NEED TO PUT -- CREATE A 4837 03:23:16,920 --> 03:23:21,960 TEXT FILL, DOT-TXT FILE, PUT CAS 4838 03:23:21,960 --> 03:23:25,880 NUMBERS, INCHI KEY, YOU CAN MIX 4839 03:23:25,880 --> 03:23:30,920 IF YOU DON'T HAVE CAS NUMBER, 4840 03:23:30,920 --> 03:23:34,640 JUST DTXSID, OPERA WILL FIGURE 4841 03:23:34,640 --> 03:23:38,480 AND GET THE QSAR VERSION. 4842 03:23:38,480 --> 03:23:44,280 YOU CAN INPUT IN SMILES, SDF, 4843 03:23:44,280 --> 03:23:49,320 MOL FORMAT, OPERA WILL PROCESS 4844 03:23:49,320 --> 03:23:50,080 AND PARSE IT. 4845 03:23:50,080 --> 03:23:52,400 SO, THAT WAS ABOUT THE INPUT. 4846 03:23:52,400 --> 03:23:54,560 NOW FOR THE OUTPUT, YOU DON'T 4847 03:23:54,560 --> 03:23:56,520 JUST GET THE PREDICTED VALUE. 4848 03:23:56,520 --> 03:24:01,240 THIS IS VERY IMPORTANT STEP. 4849 03:24:01,240 --> 03:24:02,560 I HIGHLY RECOMMEND THAT THE 4850 03:24:02,560 --> 03:24:05,840 USERS DO NOT JUST TAKE THE 4851 03:24:05,840 --> 03:24:07,440 PREDICTION, AND USE IT WITHOUT 4852 03:24:07,440 --> 03:24:09,040 PAYING ATTENTION TO THE OTHER 4853 03:24:09,040 --> 03:24:10,440 INFORMATION THAT OPERA PROVIDES. 4854 03:24:10,440 --> 03:24:13,520 NOT JUST FOR OPERA, FOR ANY QSAR 4855 03:24:13,520 --> 03:24:13,800 MODEL. 4856 03:24:13,800 --> 03:24:17,360 YOU NEED TO TAKE A LOOK AT 4857 03:24:17,360 --> 03:24:19,560 APPLICABILITY DOMAIN, ACCURACY 4858 03:24:19,560 --> 03:24:20,400 INDEX FOR EACH PREDICTION. 4859 03:24:20,400 --> 03:24:22,480 IF YOU WANT TO GO FURTHER YOU 4860 03:24:22,480 --> 03:24:24,880 CAN TAKE A LOOK AT THE 4861 03:24:24,880 --> 03:24:29,280 CONFIDENCE INTERVAL WHICH WE 4862 03:24:29,280 --> 03:24:31,120 ADDED TO OVERLAY THE INHERITED 4863 03:24:31,120 --> 03:24:33,760 VARIABILITY OF THE DATA BECAUSE 4864 03:24:33,760 --> 03:24:36,920 WE KNOW ALL EXPERIMENTAL DATA 4865 03:24:36,920 --> 03:24:38,560 COMES WITH VARIABILITY. 4866 03:24:38,560 --> 03:24:41,080 WE IMPLEMENTED AND MADE IT 4867 03:24:41,080 --> 03:24:41,840 AVAILABLE THROUGH OPERA 4868 03:24:41,840 --> 03:24:45,920 PREDICTIONS SO THAT YOU HAVE AN 4869 03:24:45,920 --> 03:24:48,760 INTERVAL, AND THAT GIVES AN 4870 03:24:48,760 --> 03:24:49,600 ESTIMATE OF THE UNCERTAINTY 4871 03:24:49,600 --> 03:24:57,600 ABOUT EACH ONE OF THE 4872 03:24:57,600 --> 03:24:58,240 PREDICTION, PREDICTION-SPECIFIC 4873 03:24:58,240 --> 03:24:58,840 AND MODEL-SPECIFIC, YOU DON'T 4874 03:24:58,840 --> 03:25:04,080 GET THE SAME INTERVAL FOR ALL, 4875 03:25:04,080 --> 03:25:06,800 CAN YOU GO FURTHER AND SEE HOW 4876 03:25:06,800 --> 03:25:10,200 SIMILAR THEY ARE AND THIS IS AN 4877 03:25:10,200 --> 03:25:12,800 IMPORTANT FACT THAT WHEN I SAY 4878 03:25:12,800 --> 03:25:15,120 SIMILAR I DON'T MEAN 4879 03:25:15,120 --> 03:25:16,840 STRUCTURALLY LIKE VISUALLY 4880 03:25:16,840 --> 03:25:19,240 SIMILAR BUT SIMILARITY IS 4881 03:25:19,240 --> 03:25:21,360 DEPENDENT ON THE SPECIFIC 4882 03:25:21,360 --> 03:25:24,080 ENDPOINT, MEANING THAT IT'S VERY 4883 03:25:24,080 --> 03:25:25,480 RELATIVE AND ONLY THE 4884 03:25:25,480 --> 03:25:31,040 DESCRIPTORS THAT WERE SELECTED 4885 03:25:31,040 --> 03:25:32,040 AS THE HIGHEST IMPORTANT 4886 03:25:32,040 --> 03:25:34,880 DESCRIPTS FOR FOR THAT ENDPOINT 4887 03:25:34,880 --> 03:25:38,080 ARE USED TO DETERMINE SIMILARITY 4888 03:25:38,080 --> 03:25:39,560 FOR FIVE NEAREST NEIGHBORS. 4889 03:25:39,560 --> 03:25:48,240 AND YOU GET A LOT OF OTHER 4890 03:25:48,240 --> 03:25:51,320 INFORMATION, LIKE THE INCHI KEY, 4891 03:25:51,320 --> 03:25:55,000 PREDICTED AND EXPERIMENTAL 4892 03:25:55,000 --> 03:25:57,560 VALUES AS WELL. 4893 03:25:57,560 --> 03:25:59,600 PREDICTIONS, THEY ARE AVAILABLE 4894 03:25:59,600 --> 03:26:01,040 ON NICEATM'S ICE. 4895 03:26:01,040 --> 03:26:03,240 YOU CAN DOWNLOAD THEM IN BATCH 4896 03:26:03,240 --> 03:26:05,840 MODE AND YOU CAN TAKE A LOOK AT 4897 03:26:05,840 --> 03:26:07,720 THEM ONE BY ONE. 4898 03:26:07,720 --> 03:26:10,280 YOU CAN ALSO ACCESS THEM THROUGH 4899 03:26:10,280 --> 03:26:12,280 THE EPA'S DASHBOARD, AND YOU CAN 4900 03:26:12,280 --> 03:26:14,800 ALSO DOWNLOAD THEM IN BATCH 4901 03:26:14,800 --> 03:26:19,400 MODE, INPUT THE CAS NUMBER OR 4902 03:26:19,400 --> 03:26:25,560 DSS TOX IDs, AND RUN THEM, OR 4903 03:26:25,560 --> 03:26:28,360 USE THE INTERFACE TO LOOK AT 4904 03:26:28,360 --> 03:26:31,880 SPECIFIC MODELS AND THEIR 4905 03:26:31,880 --> 03:26:32,200 PREDICTIONS. 4906 03:26:32,200 --> 03:26:34,520 JUST RECENTLY WE WORKED WITH THE 4907 03:26:34,520 --> 03:26:38,240 EPA TO ADD OPERA AND MAKE IT 4908 03:26:38,240 --> 03:26:39,800 AVAILABLE ON THE PRECISION 4909 03:26:39,800 --> 03:26:41,320 PLATFORM AS WELL. 4910 03:26:41,320 --> 03:26:43,960 NOW YOU HAVE OPERA, LATEST 4911 03:26:43,960 --> 03:26:47,880 VERSION OF OPERA, RUNNING THERE. 4912 03:26:47,880 --> 03:26:50,520 AND IN ADDITION TO THOSE ONLINE 4913 03:26:50,520 --> 03:26:54,440 RESOURCES, IF YOU ARE FAMILIAR 4914 03:26:54,440 --> 03:26:57,080 WITH THE OECD QSAR TOOLBOX NOW 4915 03:26:57,080 --> 03:26:59,480 WE HAVE A PLUG-IN FOR OPERA 4916 03:26:59,480 --> 03:27:02,640 THAT'S AVAILABLE TO ADD TO THE 4917 03:27:02,640 --> 03:27:04,400 OECD TOOLBOX, SO YOU CAN GET 4918 03:27:04,400 --> 03:27:05,600 OPERA PREDICTIONS WITHIN THE 4919 03:27:05,600 --> 03:27:06,800 TOOLBOX AND COMPARE THEM WITH 4920 03:27:06,800 --> 03:27:10,560 OTHER TOOLS AS WELL. 4921 03:27:10,560 --> 03:27:12,280 WITH THAT, THANK YOU, EVERYONE, 4922 03:27:12,280 --> 03:27:14,000 FOR YOUR ATTENTION. 4923 03:27:14,000 --> 03:27:15,440 THIS IS THE GREAT TEAM THAT WE 4924 03:27:15,440 --> 03:27:19,720 HAVE BEHIND ALL THIS GREAT WORK. 4925 03:27:19,720 --> 03:27:21,160 IF WE DON'T HAVE ALL THE 4926 03:27:21,160 --> 03:27:25,520 PICTURES HERE, THE TEAM IS 4927 03:27:25,520 --> 03:27:26,640 ALWAYS EXPANDING AND GROWING, SO 4928 03:27:26,640 --> 03:27:28,520 PROBABLY THE PICTURE IS MISSING 4929 03:27:28,520 --> 03:27:30,160 A FEW PEOPLE. 4930 03:27:30,160 --> 03:27:32,240 THANKS TO THE NICEATM GROUP, AND 4931 03:27:32,240 --> 03:27:32,800 THANK YOU ALL. 4932 03:27:32,800 --> 03:27:41,400 [APPLAUSE] 4933 03:27:41,400 --> 03:27:42,200 >> THANKS, KAMEL. 4934 03:27:42,200 --> 03:27:44,480 DO WE HAVE ANY QUESTIONS IN THE 4935 03:27:44,480 --> 03:27:49,040 ROOM FIRST OF ALL? 4936 03:27:49,040 --> 03:27:49,960 JOHN? 4937 03:27:49,960 --> 03:27:51,480 >> YEAH, THANKS, GREAT, KAMEL. 4938 03:27:51,480 --> 03:27:54,480 ICE AND OPERA, ARE THEY 4939 03:27:54,480 --> 03:27:56,480 AVAILABLE ONLINE AND DOWNLOAD? 4940 03:27:56,480 --> 03:27:57,160 >> BOTH WHAT? 4941 03:27:57,160 --> 03:27:58,720 >> AVAILABLE DOWNLOAD AND 4942 03:27:58,720 --> 03:27:59,200 ONLINE? 4943 03:27:59,200 --> 03:27:59,720 OR JUST ONLINE? 4944 03:27:59,720 --> 03:28:03,760 >> ICE IS ONLY AVAILABLE 4945 03:28:03,760 --> 03:28:03,960 ONLINE. 4946 03:28:03,960 --> 03:28:05,680 >> ONLINE, OKAY. 4947 03:28:05,680 --> 03:28:09,520 >> JUST LIKE THE EPA DASHBOARD. 4948 03:28:09,520 --> 03:28:11,000 OPERA, IF YOU WANT TO RUN OUT 4949 03:28:11,000 --> 03:28:12,280 USUAL COMPUTER YOU HAVE TO 4950 03:28:12,280 --> 03:28:17,320 DOWNLOAD AND INSTALL IT. 4951 03:28:17,320 --> 03:28:18,080 IT'S AN APPLICATION. 4952 03:28:18,080 --> 03:28:19,960 IF YOU JUST WANT TO ACCESS 4953 03:28:19,960 --> 03:28:23,800 PREDICTIONS YOU CAN EITHER GO ON 4954 03:28:23,800 --> 03:28:25,760 ICE AND YOU'LL SEE THE 4955 03:28:25,760 --> 03:28:27,080 PREDICTIONS FOR SPECIFIC MODELS 4956 03:28:27,080 --> 03:28:29,720 OR IN THE EPA DASHBOARD AS WELL, 4957 03:28:29,720 --> 03:28:31,120 YOU CAN SEE PREDICTIONS THAT ARE 4958 03:28:31,120 --> 03:28:33,120 ALREADY SAVED AND UPLOADED 4959 03:28:33,120 --> 03:28:33,440 THERE. 4960 03:28:33,440 --> 03:28:38,720 >> JUST TO ADD TO THAT, THE ICE 4961 03:28:38,720 --> 03:28:40,240 DATA ARE AVAILABLE 4962 03:28:40,240 --> 03:28:44,920 PROGRAMMATICALLY THROUGH A REST 4963 03:28:44,920 --> 03:28:49,440 API, SO YOU CAN -- IF YOU WANT 4964 03:28:49,440 --> 03:28:52,600 TO ACCESS COMPUTATIONAL 4965 03:28:52,600 --> 03:28:53,280 TOXICOLOGY TOOLS AND WORKFLOWS, 4966 03:28:53,280 --> 03:28:56,080 THEN YOU HAVE TO GO THROUGH THE 4967 03:28:56,080 --> 03:28:57,400 DASHBOARD AS A HUMAN, BUT IF YOU 4968 03:28:57,400 --> 03:28:59,840 JUST WANT TO PULL THE DATA FROM 4969 03:28:59,840 --> 03:29:02,240 THE DATABASE YOU CAN DO THAT 4970 03:29:02,240 --> 03:29:04,000 PROGRAMMATICALLY THROUGH THE 4971 03:29:04,000 --> 03:29:04,160 API. 4972 03:29:04,160 --> 03:29:05,120 >> SOUND GOOD. 4973 03:29:05,120 --> 03:29:13,200 THANKS. 4974 03:29:13,200 --> 03:29:15,280 4975 03:29:15,280 --> 03:29:19,200 >> ANY QUESTIONS ONLINE, DAVE? 4976 03:29:19,200 --> 03:29:20,800 4977 03:29:20,800 --> 03:29:24,720 >> YEAH, THERE'S ONE FROM AMY 4978 03:29:24,720 --> 03:29:26,680 KYLE FROM UC-BERKELEY. 4979 03:29:26,680 --> 03:29:28,240 ARE YOU INCLUDING PERSISTENCE IN 4980 03:29:28,240 --> 03:29:34,880 THE TRAITS YOU'RE WORKING ON? 4981 03:29:34,880 --> 03:29:40,480 >> THERE ARE MODELS OF 4982 03:29:40,480 --> 03:29:42,440 ENVIRONMENTAL FATE, YES, LIKE 4983 03:29:42,440 --> 03:29:44,640 SOIL DEGRADATION, A FEW MODELS 4984 03:29:44,640 --> 03:29:50,440 THERE, YES. 4985 03:29:50,440 --> 03:29:50,720 >> OKAY. 4986 03:29:50,720 --> 03:29:57,040 >> THANK YOU ALL. 4987 03:29:57,040 --> 03:29:57,440 4988 03:29:57,440 --> 03:29:59,840 >> OKAY. 4989 03:29:59,840 --> 03:30:02,720 SO, THAT CONCLUDES DAY 1 OF THE 4990 03:30:02,720 --> 03:30:04,280 ICCVAM PUBLIC FORUM. 4991 03:30:04,280 --> 03:30:06,440 THANK YOU FOR YOUR 4992 03:30:06,440 --> 03:30:06,920 PARTICIPATION. 4993 03:30:06,920 --> 03:30:08,480 AND WE'RE VERY EXCITED FOR DAY 2 4994 03:30:08,480 --> 03:30:08,840 TOMORROW. 4995 03:30:08,840 --> 03:30:11,040 WE'VE GOT LOTS OF REALLY GREAT 4996 03:30:11,040 --> 03:30:12,800 TALKS ON THE AGENDA TOMORROW. 4997 03:30:12,800 --> 03:30:15,600 WE ALSO HAVE QUITE A NUMBER OF 4998 03:30:15,600 --> 03:30:17,720 PUBLIC COMMENTS FROM A VARIETY 4999 03:30:17,720 --> 03:30:20,360 OF DIFFERENT STAKEHOLDERS THAT 5000 03:30:20,360 --> 03:30:21,960 WILL BE EITHER PRESENTING SLIDES 5001 03:30:21,960 --> 03:30:24,400 OR JUST PROVIDING ORAL PUBLIC 5002 03:30:24,400 --> 03:30:26,040 COMMENTS, AND THOSE WILL BE 5003 03:30:26,040 --> 03:30:27,000 HAPPENING DURING THE MORNING 5004 03:30:27,000 --> 03:30:31,520 TOMORROW SO NOT TO BE MISSED. 5005 03:30:31,520 --> 03:30:34,480 SO, WE WILL RECONVENE AT 9:00 5006 03:30:34,480 --> 03:30:35,480 A.M. SHARP TOMORROW. 5007 03:30:35,480 --> 03:30:36,560 EVERYONE, HAVE A WONDERFUL 5008 03:30:36,560 --> 03:30:38,240 AFTERNOON AND EVENING. 5009 03:30:38,240 --> 03:30:40,440 WE'LL SEE YOU TOMORROW. 5010 03:30:40,440 --> 00:00:00,000 [APPLAUSE]