1 00:00:11,440 --> 00:00:13,640 Welcome to the Clinical Center Grand Rounds, 2 00:00:13,640 --> 00:00:17,440 a weekly series of educational lectures for physicians and 3 00:00:17,440 --> 00:00:20,080 health care professionals broadcast from the Clinical 4 00:00:20,080 --> 00:00:23,040 Center at the National Institutes of Health in 5 00:00:23,040 --> 00:00:24,840 Bethesda, MD. 6 00:00:24,840 --> 00:00:28,400 The NIH Clinical Center is the world's largest hospital totally 7 00:00:28,400 --> 00:00:32,080 dedicated to investigational research and leads the global 8 00:00:32,080 --> 00:00:35,040 effort in training today's investigators and discovering 9 00:00:35,040 --> 00:00:37,200 tomorrow's cures. 10 00:00:37,200 --> 00:00:47,640 Learn more by visiting us online at http://clinicalcenter.nih.gov 11 00:00:47,640 --> 00:00:54,080 TODAY WE'RE HONORED TO HAVE TWO 12 00:00:54,080 --> 00:00:57,640 WHO WILL SPEAK TODAY ON COVID-19 13 00:00:57,640 --> 00:01:03,440 CONVALESCENT PLASMA LESSONS 14 00:01:03,440 --> 00:01:05,080 LEARNED. 15 00:01:05,080 --> 00:01:09,040 OUR FIRST SPEAKER IS DR. KAMILLE 16 00:01:09,040 --> 00:01:12,560 WEST MITCHELL. 17 00:01:12,560 --> 00:01:14,320 DR. WEST MITCHELL EARNED HER 18 00:01:14,320 --> 00:01:16,240 MEDICAL DEGREE FROM THE 19 00:01:16,240 --> 00:01:23,400 UNIVERSITY OF WEST INDIES. 20 00:01:23,400 --> 00:01:25,880 FOLLOWING HER RESIDENCY SHE 21 00:01:25,880 --> 00:01:26,160 JOINED NIH AS A CLINICAL FELLOW 22 00:01:26,160 --> 00:01:28,400 IN TRANSFUSION MEDICINE. 23 00:01:28,400 --> 00:01:53,200 SHE BECAME A STAFF PHYSICIAN. 24 00:01:53,200 --> 00:01:55,880 DR. WEST MITCHELL IS THE MEDICAL 25 00:01:55,880 --> 00:01:58,960 DIRECTOR SERVING PEDIATRIC AND 26 00:01:58,960 --> 00:02:03,920 ADULT PATIENTS TO SUPPORT 27 00:02:03,920 --> 00:02:27,760 STEM-CELL TRANSPLANSTEM-- CELL TRANSPLANTA TION. 28 00:02:27,760 --> 00:02:32,080 OUR SECOND SPEAKER IS 29 00:02:32,080 --> 00:02:37,560 DR. VALERIA DE GIORGI. 30 00:02:37,560 --> 00:02:41,960 SHE EARNED HER PhD IN CHEMICAL 31 00:02:41,960 --> 00:02:43,600 SCIENCES FROM THE UNIVERSITY OF 32 00:02:43,600 --> 00:03:08,760 NAPLES IN ITALY. 33 00:03:08,760 --> 00:03:11,960 SHE OVERSEES THE TESTING LAB AND 34 00:03:11,960 --> 00:03:14,400 LEADS IMPLEMENTATION VALIDATION 35 00:03:14,400 --> 00:03:16,840 OF SATISFACTORY LOGICAL ASSAYS 36 00:03:16,840 --> 00:03:54,400 FOR COVID-19 TESTING. 37 00:03:54,400 --> 00:03:55,680 ADDITIONALLY DR. DE GIORGI IS 38 00:03:55,680 --> 00:03:58,000 DEVELOPING A PROGRAM TO TEST 39 00:03:58,000 --> 00:04:01,480 DONORS DONATED BLOOD COMPONENTS 40 00:04:01,480 --> 00:04:06,600 USING NOVEL AND UNCONVENTIONAL 41 00:04:06,600 --> 00:04:06,920 TECHNIQUES. 42 00:04:06,920 --> 00:04:11,440 SHE IS A MEMBER OF THE SOUTHERN 43 00:04:11,440 --> 00:04:26,280 SOCIETY O SEROLOGY. 44 00:04:26,280 --> 00:04:30,680 AND HAS RECEIVED SEVERAL AWARDS. 45 00:04:30,680 --> 00:04:35,320 DR. DE GIORGI'S TOPIC IS 46 00:04:35,320 --> 00:04:40,000 SEROLOGICAL ASSAYS IN COVID-1 COVID-19 47 00:04:40,000 --> 00:04:42,840 CONVALESCENT PLASMA DONORS. 48 00:04:42,840 --> 00:04:43,880 PLEASE WELCOME DR. KAMILLE WEST 49 00:04:43,880 --> 00:04:45,080 THANK YOU VERY MUCH AGAIN FOR 50 00:04:45,080 --> 00:04:49,480 THE INVITATION TO PARTICIPATE. 51 00:04:49,480 --> 00:04:51,600 I HAVE NO CONFLICT OF INTEREST 52 00:04:51,600 --> 00:04:59,880 TO DISCLOSE. 53 00:04:59,880 --> 00:05:06,360 I WILL BE DISCUSSING THE USE OF 54 00:05:06,360 --> 00:05:10,000 UNLICENSED BLOOD PRODUCT -- 55 00:05:10,000 --> 00:05:11,760 TODAY WE WILL BE REVIEWING THE 56 00:05:11,760 --> 00:05:14,480 EARLY DAYS OF THE COVID-19 57 00:05:14,480 --> 00:05:16,400 PANDEMIC AND WHAT THE BLOOD BANK 58 00:05:16,400 --> 00:05:17,880 POINT OF VIEW WAS DURING THAT 59 00:05:17,880 --> 00:05:21,400 TIME. 60 00:05:21,400 --> 00:05:24,040 AND THEN SUMMARIZING ELEMENTS OF 61 00:05:24,040 --> 00:05:26,160 OUR EXPERIENCE AS WELL AS OTHER 62 00:05:26,160 --> 00:05:27,600 LESSONS WE LEARNED ALONG THE 63 00:05:27,600 --> 00:05:28,760 WAY. 64 00:05:28,760 --> 00:05:31,080 A BRIEF INTRODUCTION -- YOU MAY 65 00:05:31,080 --> 00:05:33,240 HAVE HEARD IN THE INTRODUCTION 66 00:05:33,240 --> 00:05:34,880 THAT THE DEPARTMENT OF 67 00:05:34,880 --> 00:05:36,440 TRANSFUSION MEDICINE COMPRISES 68 00:05:36,440 --> 00:05:38,720 MULTIPLE SECTIONS. 69 00:05:38,720 --> 00:05:40,640 OUR SECTION THE BLOOD SERVICES 70 00:05:40,640 --> 00:05:42,200 SECTION IS CONCERNED WITH THE 71 00:05:42,200 --> 00:05:46,480 HEALTHY BLOOD DONOR CENTERS FOR 72 00:05:46,480 --> 00:05:48,360 COLLECTION OF BLOOD TO BE USED 73 00:05:48,360 --> 00:05:50,280 AS WELL AS OVERSIGHT. 74 00:05:50,280 --> 00:05:52,160 SO WE SOMETIMES SAY WE ARE THE 75 00:05:52,160 --> 00:05:55,000 HUMAN SERVICES SECTION. 76 00:05:55,000 --> 00:05:58,680 AND THE REMAINDER OF THE 77 00:05:58,680 --> 00:06:00,240 SECTIONS ARE MOSTLY LABORATORY 78 00:06:00,240 --> 00:06:01,520 BASED. 79 00:06:01,520 --> 00:06:04,280 OUR BLOOD BANK IS A SMALL 80 00:06:04,280 --> 00:06:07,320 HOSPITAL BASED BLOOD BANK. 81 00:06:07,320 --> 00:06:17,040 WE COLLECT 4,000 UNITS A YEAR. 82 00:06:17,040 --> 00:06:20,640 SO IN DECEMBER 2019 WHEN WE AND 83 00:06:20,640 --> 00:06:22,160 THE WORLD BEGAN TO RECOGNIZE 84 00:06:22,160 --> 00:06:25,080 THAT THERE WAS AN EMERGING 85 00:06:25,080 --> 00:06:27,800 INFECTIOUS THREAT THAT MIGHT 86 00:06:27,800 --> 00:06:30,160 AFFECT THE AVAILABILITY AND 87 00:06:30,160 --> 00:06:33,480 SAFETY OF THE BLOOD SUPPLY -- 88 00:06:33,480 --> 00:06:35,040 BLOOD CENTERS STARTED 89 00:06:35,040 --> 00:06:36,920 IMPLEMENTING DONOR EXCLUSIONS TO 90 00:06:36,920 --> 00:06:41,440 TRY TO REDUCE SPREAD OF THIS 91 00:06:41,440 --> 00:06:43,000 NOVEL CORONAVIRUS AS IT WAS 92 00:06:43,000 --> 00:06:44,520 CALLED. 93 00:06:44,520 --> 00:06:47,440 WE IMPLEMENTED SOCIAL DISTANCING 94 00:06:47,440 --> 00:06:51,080 AND DISINFECTION OF SURFACEs 95 00:06:51,080 --> 00:06:53,320 AND WE ASKED OURSELVES AS THE 96 00:06:53,320 --> 00:06:54,680 COLLECTION ASPECT OF THE DETAIL 97 00:06:54,680 --> 00:06:56,080 IS THERE ANYTHING ELSE THAT WE 98 00:06:56,080 --> 00:07:00,080 CAN DO TO ADDRESS THE EMERGING 99 00:07:00,080 --> 00:07:01,040 THREAT. 100 00:07:01,040 --> 00:07:03,760 THE LABORATORY SECTIONS IN THE 101 00:07:03,760 --> 00:07:07,200 DTM ARE OBVIOUSLY BUSY IN 102 00:07:07,200 --> 00:07:09,960 VALIDATING CLINICAL ASSAYS AND 103 00:07:09,960 --> 00:07:11,280 YOU'LL HEAR A LITTLE BIT ABOUT 104 00:07:11,280 --> 00:07:14,080 THAT LATER BUT AS COLLECTIONS WE 105 00:07:14,080 --> 00:07:19,280 THOUGHT WHAT WE COULD DO WOULD 106 00:07:19,280 --> 00:07:23,800 BE TO COLLECT COVID CONVALESCENT 107 00:07:23,800 --> 00:07:25,840 PLASMA? 108 00:07:25,840 --> 00:07:28,400 THE PRINCIPLE OF COLLECTING 109 00:07:28,400 --> 00:07:29,880 BLOOD FROM PERSONS WHO HAVE 110 00:07:29,880 --> 00:07:31,680 RECOVERED FROM AN INFECTIOUS 111 00:07:31,680 --> 00:07:36,280 DISEASE WHO MAY HAVE DEVELOPED 112 00:07:36,280 --> 00:07:39,560 ANTI BODIES AND HAS BEEN USED 113 00:07:39,560 --> 00:07:41,320 FOR OVER A HUNDRED YEARS. 114 00:07:41,320 --> 00:07:47,240 IN THE SPANISH INFLUENZA 115 00:07:47,240 --> 00:07:51,240 PANDEMIC -- IT WAS ALSO 116 00:07:51,240 --> 00:07:55,400 ATTEMPTED -- AND OTHER SEVERE 117 00:07:55,400 --> 00:07:57,160 CORONAVIRUS INFECTIOUSES. 118 00:07:57,160 --> 00:08:01,800 SO IN EARLY 2020 WHEN THERE WERE 119 00:08:01,800 --> 00:08:05,080 NO PREVENTIVE MODALITIES 120 00:08:05,080 --> 00:08:07,160 AVAILABLE WE AND OTHERS 121 00:08:07,160 --> 00:08:08,200 THROUGHOUT THE UNITED STATES 122 00:08:08,200 --> 00:08:09,760 ANTICIPATED THERE MIGHT BE A 123 00:08:09,760 --> 00:08:12,280 DEMAND FOR CONVALESCENT PLASMA 124 00:08:12,280 --> 00:08:13,920 WE THOUGHT IT WAS SOMETHING THAT 125 00:08:13,920 --> 00:08:16,720 WE COULD READILY MOBILIZE 126 00:08:16,720 --> 00:08:18,720 INTERNALLY BECAUSE WE HAD THE 127 00:08:18,720 --> 00:08:20,160 DEVICES THAT WERE USED TO 128 00:08:20,160 --> 00:08:22,160 COLLECT THE PLASMA. 129 00:08:22,160 --> 00:08:23,800 AND THE EXPERTISE. 130 00:08:23,800 --> 00:08:26,880 THEY ARE AWARE OF HOW TO COLLECT 131 00:08:26,880 --> 00:08:29,200 AND IN-HOUSE THE REGULATORY AND 132 00:08:29,200 --> 00:08:31,640 QUALITY EXPERT ANALYSIS TO HELP 133 00:08:31,640 --> 00:08:34,480 US NAVIGATE. 134 00:08:34,480 --> 00:08:37,280 AND FURTHERMORE IN THE FIRST 135 00:08:37,280 --> 00:08:41,120 THREE MONTHS -- APRIL, MAY, JUNE 136 00:08:41,120 --> 00:08:42,800 IT WAS VERY DIFFICULT FOR 137 00:08:42,800 --> 00:08:46,160 HOSPITALS TO OBTAIN CONVALESCENT 138 00:08:46,160 --> 00:08:48,560 PLASMA BECAUSE THAT PROCESS WAS 139 00:08:48,560 --> 00:08:52,080 STILL RAMPING UP. 140 00:08:52,080 --> 00:08:57,520 THE EARLY PARTS -- IT WAS 141 00:08:57,520 --> 00:09:02,800 ENCOURAGING -- SO WE ELECTED TO 142 00:09:02,800 --> 00:09:06,320 WRITE A PROTOCOL BASED ON PLASMA 143 00:09:06,320 --> 00:09:07,160 COLLECTION. 144 00:09:07,160 --> 00:09:09,120 WE COLLECTED PLASMA FROM DONORS 145 00:09:09,120 --> 00:09:11,480 WHO WERE SCREENED AND MET ARE 146 00:09:11,480 --> 00:09:13,800 THE RELATIVE BLOOD DONOR 147 00:09:13,800 --> 00:09:16,280 CRITERIA AS WELL AS THE 148 00:09:16,280 --> 00:09:17,640 DOCUMENTED EVIDENCE. 149 00:09:17,640 --> 00:09:23,760 WE ELECT TO PERFORM PLASMA -- 150 00:09:23,760 --> 00:09:27,000 BECAUSE WE COULD COLLECT THREE 151 00:09:27,000 --> 00:09:30,600 TO FOUR TIMES AS MUCH. 152 00:09:30,600 --> 00:09:36,680 AND ALSO WE DEVELOPED AN INITIAL 153 00:09:36,680 --> 00:09:37,600 PLAN -- 154 00:09:37,600 --> 00:09:39,280 [ AUDIO DIFFICULTIES ] 155 00:09:39,280 --> 00:09:42,520 FOR QUALIFYING THE PLASMA THAT 156 00:09:42,520 --> 00:09:44,760 WE COLLECTED AND MORE ON THAT IN 157 00:09:44,760 --> 00:09:46,640 FURTHER SLIDES. 158 00:09:46,640 --> 00:09:48,840 NOTABLY THE CCP THAT WE 159 00:09:48,840 --> 00:09:52,080 COLLECTED COULD BE USED UNDER 160 00:09:52,080 --> 00:10:02,360 ONE OF TWO MECHANISMS. 161 00:10:02,360 --> 00:10:05,440 THERE WERE CLINICAL TRIALS IN 162 00:10:05,440 --> 00:10:10,680 INSTITUTIONS AND THE FDA GRANTED 163 00:10:10,680 --> 00:10:20,360 EMERGENCY USE AUTHORIZATION. 164 00:10:20,360 --> 00:10:26,840 WE INTERVIEWED AND EVALUATED THE 165 00:10:26,840 --> 00:10:35,520 DONORS. 166 00:10:35,520 --> 00:10:37,640 AND TO MITIGATE POTENTIALLY 167 00:10:37,640 --> 00:10:40,920 FATAL COMPLICATIONS OF 168 00:10:40,920 --> 00:10:45,240 TRANSFUSIONS. 169 00:10:45,240 --> 00:10:51,360 WE SELECTED DONORS WHO WERE 170 00:10:51,360 --> 00:10:54,560 NEGATIVE FOR ANTIBODIES. 171 00:10:54,560 --> 00:10:55,880 AND FURTHER MORE WE HAVE TO 172 00:10:55,880 --> 00:10:57,800 CONFIRM THAT THE DONORS DID IN 173 00:10:57,800 --> 00:10:59,800 FACT HAVE EVIDENCE OF COVID 174 00:10:59,800 --> 00:11:01,680 CONVALESCENT AS SPECIFIED BY THE 175 00:11:01,680 --> 00:11:03,720 REGULATORY GUIDANCE AND THIS IS 176 00:11:03,720 --> 00:11:07,560 WHERE IT BECAME COLORFUL. 177 00:11:07,560 --> 00:11:11,680 THE SYMPTOMS CHANGED OVER TIME 178 00:11:11,680 --> 00:11:17,680 AND BECAME MORE RESTRICTIVE. 179 00:11:17,680 --> 00:11:21,520 AND THEN THERE WAS DISCUSSION OF 180 00:11:21,520 --> 00:11:24,840 WHETHER LOSS OF SMELL AND TASTE 181 00:11:24,840 --> 00:11:27,280 THAT MIGHT MAKE YOU INELIGIBLE 182 00:11:27,280 --> 00:11:36,560 TO DONATE. 183 00:11:36,560 --> 00:11:39,160 EVENTUALLY THE CRITERIA CHANGED 184 00:11:39,160 --> 00:11:41,160 TO ONLY 14 DAYS OF CONVALESCENT 185 00:11:41,160 --> 00:11:43,680 WITH NO NEED FOR A NEGATIVE 186 00:11:43,680 --> 00:11:45,280 FOLLOW-UP TEST AND THEN TO 10 187 00:11:45,280 --> 00:11:49,080 DAYS. 188 00:11:49,080 --> 00:11:51,280 IT WAS TRICKY ESPECIALLY IN THE 189 00:11:51,280 --> 00:11:52,520 BEGINNING. 190 00:11:52,520 --> 00:11:55,360 DONORS WERE REQUIRED TO HAVE A 191 00:11:55,360 --> 00:11:58,640 POSITIVE TEST AND THAT WAS 192 00:11:58,640 --> 00:12:00,640 SPECIFIED THROUGH A MOLECULAR 193 00:12:00,640 --> 00:12:01,080 TEST. 194 00:12:01,080 --> 00:12:02,600 AS YOU RECALL THERE WERE A 195 00:12:02,600 --> 00:12:05,960 NUMBER OF TESTS OVER 100 TESTS 196 00:12:05,960 --> 00:12:08,520 FOR SARS-CO- INDIVIDUAL 2 THAT 197 00:12:08,520 --> 00:12:10,680 FLOODED THE MARKET AND ONLY SOME 198 00:12:10,680 --> 00:12:14,280 OF THEM WERE GRANTED EMERGENCY 199 00:12:14,280 --> 00:12:27,560 USE AUTHORIZATION. 200 00:12:27,560 --> 00:12:30,080 OR IF THERE WAS NO HISTORY OF 201 00:12:30,080 --> 00:12:32,920 SYMPTOMS THE DONOR WOULD BE 202 00:12:32,920 --> 00:12:37,480 QUALIFIED BY TWO SEPARATE TESTS. 203 00:12:37,480 --> 00:12:40,880 AND IN JANUARY 2021 THE FDA 204 00:12:40,880 --> 00:12:43,960 INCLUDED RESTRICTIONS OF 205 00:12:43,960 --> 00:12:46,520 VACCINATION AND THOSE WHO HAD 206 00:12:46,520 --> 00:12:51,240 RECEIVED MONOCLONAL THERAPY. 207 00:12:51,240 --> 00:12:52,800 ADDITIONAL REGULATORY CHANGES 208 00:12:52,800 --> 00:12:58,280 HAD AN IMPACT ON OUR WORKFLOW. 209 00:12:58,280 --> 00:13:02,160 I WILL NOT SPEND A LOT OF TIME 210 00:13:02,160 --> 00:13:04,680 TALKING ABOUT THE ACTUAL ASSAYS 211 00:13:04,680 --> 00:13:07,440 BUT AS THE REQUIREMENTS CHANGED 212 00:13:07,440 --> 00:13:08,880 THE THRESHOLDS WERE HIGHER THIS 213 00:13:08,880 --> 00:13:14,480 HAD AN IMPACT ON OUR 214 00:13:14,480 --> 00:13:14,800 COLLECTIONS. 215 00:13:14,800 --> 00:13:17,120 IN APRIL 2020 THERE WERE NO 216 00:13:17,120 --> 00:13:18,680 ASSAYS AVAILABLE AND THE 217 00:13:18,680 --> 00:13:20,080 RECOMMENDATION AT THAT TIME WAS 218 00:13:20,080 --> 00:13:22,280 FOR BLOOD COLLECTORS TO IDENTIFY 219 00:13:22,280 --> 00:13:26,440 DONORS WHO MET THE CLINICAL 220 00:13:26,440 --> 00:13:29,280 CRITERIA AND COLLECT PLASMA. 221 00:13:29,280 --> 00:13:31,960 AND ONCE TESTING BECAME 222 00:13:31,960 --> 00:13:33,840 AVAILABLE THEN TRY TO TEST AND 223 00:13:33,840 --> 00:13:36,800 DETECT IF THERE WERE 224 00:13:36,800 --> 00:13:37,760 NEUTRALIZING ANTIBODIES IN THE 225 00:13:37,760 --> 00:13:38,320 PLASMA. 226 00:13:38,320 --> 00:13:40,120 THE RECOMMENDATION WAS ALSO NOT 227 00:13:40,120 --> 00:13:42,080 EASY TO COMPLY WITH BECAUSE 228 00:13:42,080 --> 00:13:43,680 THERE WAS NOT TESTING WIDELY 229 00:13:43,680 --> 00:13:44,280 AVAILABLE. 230 00:13:44,280 --> 00:13:48,160 WE THANKFULLY FOUND A 231 00:13:48,160 --> 00:13:50,480 COLLABORATOR -- WHO WAS ABLE TO 232 00:13:50,480 --> 00:13:54,880 HELP US WITH THE FLUORESCENT 233 00:13:54,880 --> 00:14:03,080 NEUTRALIZING ASSAY. 234 00:14:03,080 --> 00:14:05,280 TO QUALIFY THE PLASMA WE HAD 235 00:14:05,280 --> 00:14:06,320 COLLECTED. 236 00:14:06,320 --> 00:14:10,720 IN AUGUST 2021 THE CCP WAS 237 00:14:10,720 --> 00:14:14,280 GRANTED THRESHOLDS AND OVER TIME 238 00:14:14,280 --> 00:14:18,080 REVISIONS OF THE EUA INCLUDED 239 00:14:18,080 --> 00:14:24,920 REVISIONS THAT WERE ACCEPTABLE. 240 00:14:24,920 --> 00:14:26,920 SO EACH TIME THERE WAS A 241 00:14:26,920 --> 00:14:31,400 REGULATORY CHANGE IN WHAT WAS 242 00:14:31,400 --> 00:14:32,800 QUALIFIED -- AND WHAT COULD BE 243 00:14:32,800 --> 00:14:35,480 TRANS FUSED WE WOULD GO BACK AND 244 00:14:35,480 --> 00:14:37,680 REVISE OUR PLAN OR STRATEGY FOR 245 00:14:37,680 --> 00:14:39,800 COLLECTING DONORS AND LOOK AT 246 00:14:39,800 --> 00:14:48,240 OUR IN-HOUSE REA IN -- HOUSE INVENTORY. 247 00:14:48,240 --> 00:14:53,720 AND TOOK DETAILED NOTES. 248 00:14:53,720 --> 00:14:56,400 AND THEN SIGNIFICANTLY IN 249 00:14:56,400 --> 00:14:58,680 FEBRUARY 2021 THE EUA CRITERIA 250 00:14:58,680 --> 00:15:04,360 NOW RESTRICT THE USE OF CCP. 251 00:15:04,360 --> 00:15:06,960 AND MORE RECENTLY IN 252 00:15:06,960 --> 00:15:08,480 DECEMBER 2021 THE RESTRICTION 253 00:15:08,480 --> 00:15:10,240 REMAINS THE SAME BUT THE ASSAYS 254 00:15:10,240 --> 00:15:13,760 USED TO QUALIFY THAT PLASMA HAVE 255 00:15:13,760 --> 00:15:17,000 NOT CHANGED WHICH MEANS FOR ANY 256 00:15:17,000 --> 00:15:20,200 FACILITIES WE STILL HAD IN-HOUSE 257 00:15:20,200 --> 00:15:21,720 PLASMA COLLECTED. 258 00:15:21,720 --> 00:15:26,240 WE WOULD THEN HAVE TO GO BACK 259 00:15:26,240 --> 00:15:27,680 AND QUALIFY WHETHER OR NOT IT 260 00:15:27,680 --> 00:15:29,440 WOULD MEET CURRENT CRITERIA. 261 00:15:29,440 --> 00:15:32,400 OUR DONOR SELECTION PROCESS WAS 262 00:15:32,400 --> 00:15:33,760 MORE RESPONSIVE THAN PROACTIVE 263 00:15:33,760 --> 00:15:38,080 BECAUSE WE FOUND THAT ONCE WE 264 00:15:38,080 --> 00:15:40,760 HOSTED OUR TRIAL CAN ACTUALLY 265 00:15:40,760 --> 00:15:44,320 THE NIH BLOOD BANK WAS ALSO 266 00:15:44,320 --> 00:15:46,920 LISTED -- TO ENCOURAGE PERSONS 267 00:15:46,920 --> 00:15:48,840 TO DONATE CONVALESCENT PLACE 268 00:15:48,840 --> 00:15:51,520 MAY. 269 00:15:51,520 --> 00:15:53,280 -- PLASMA. 270 00:15:53,280 --> 00:15:56,360 THE DONORS FOUND US. 271 00:15:56,360 --> 00:16:00,120 WE DEVELOPED AND DEVISED 272 00:16:00,120 --> 00:16:00,520 ALGORITHMS. 273 00:16:00,520 --> 00:16:02,920 WE REALLY WERE MOVED AND STRUCK 274 00:16:02,920 --> 00:16:05,440 BY THE MOTIVATED DONOR 275 00:16:05,440 --> 00:16:06,080 COMMUNITY. 276 00:16:06,080 --> 00:16:09,000 PEOPLE WANTED TO PARTICIPATE AND 277 00:16:09,000 --> 00:16:10,880 WE ALSO GOT REFERRALS FROM 278 00:16:10,880 --> 00:16:12,440 OUTSIDE HOSPITALS THAT DID NOT 279 00:16:12,440 --> 00:16:14,760 HAVE ON-SITE DONOR CENTERS SO 280 00:16:14,760 --> 00:16:15,880 THEY WERE NOT ABLE TO COLLECT 281 00:16:15,880 --> 00:16:18,040 THEIR OWN CCP AND THOSE THAT 282 00:16:18,040 --> 00:16:21,640 WERE NOT ABLE TO OBTAIN CCP FROM 283 00:16:21,640 --> 00:16:24,960 MAJOR BLOOD COLLECTORS SO WE GOT 284 00:16:24,960 --> 00:16:26,720 REFERRED DONORS AND THEN SHARED 285 00:16:26,720 --> 00:16:28,520 SOME OF THE PLASMA WITH THE 286 00:16:28,520 --> 00:16:29,480 OUTSIDE HOSPITALS. 287 00:16:29,480 --> 00:16:31,400 SO OUR PRESCREENING PROCESS IN 288 00:16:31,400 --> 00:16:33,720 THE EARLY DARK DAYS OF THE 289 00:16:33,720 --> 00:16:35,280 PANDEMIC THERE WERE CHANGES TO 290 00:16:35,280 --> 00:16:36,480 OUR OWN STRUCTURE. 291 00:16:36,480 --> 00:16:40,280 SOME OF THE STAFF WERE 292 00:16:40,280 --> 00:16:42,760 TELEWORKING. 293 00:16:42,760 --> 00:16:48,920 SO COORDINATING FEASIBLE 294 00:16:48,920 --> 00:16:51,280 WORKFLOWS TOOK SOME SNIFFING OUT 295 00:16:51,280 --> 00:16:54,280 AND WE SETTLED ON SPECIFIC RULES 296 00:16:54,280 --> 00:16:56,280 AND RESPONSES TO DONORS THAT 297 00:16:56,280 --> 00:16:57,360 WORKED WELL FOR US. 298 00:16:57,360 --> 00:17:00,760 WE ALSO HAD TO TAKE INTO ACCOUNT 299 00:17:00,760 --> 00:17:01,360 ACCESS RESTRICTIONS. 300 00:17:01,360 --> 00:17:04,760 SINCE OUR BLOOD BANK IS LOCATED 301 00:17:04,760 --> 00:17:13,720 ON THE CLINICAL CENTER. 302 00:17:13,720 --> 00:17:15,240 WE STARTED COLLECTING PLASMA IN 303 00:17:15,240 --> 00:17:17,680 THE BEGINNING WITHOUT THE 304 00:17:17,680 --> 00:17:18,200 EVALUATION SAMPLES. 305 00:17:18,200 --> 00:17:21,640 WE HAD TO REVISE OUR OPERATIONAL 306 00:17:21,640 --> 00:17:23,400 PROCESSES WITH THE OPERATIONAL 307 00:17:23,400 --> 00:17:26,680 CHANGES AND REGULATORY CHANGES. 308 00:17:26,680 --> 00:17:29,920 JUST TO GIVE YOU AN IDEA WE HAD 309 00:17:29,920 --> 00:17:32,600 TO EXCLUDE MOST OF THE DONORS 310 00:17:32,600 --> 00:17:36,960 PARTICULARLY IN THE APRIL TO MAY 2020 PERI OD WHO CONTACTED 311 00:17:36,960 --> 00:17:39,760 US. 312 00:17:39,760 --> 00:17:41,680 MOST OF THE CANDIDATE DONORS 313 00:17:41,680 --> 00:17:43,160 CONTACTED US. 314 00:17:43,160 --> 00:17:45,160 THEY FELT ILL AND WERE NOT ABLE 315 00:17:45,160 --> 00:17:47,280 TO GET A TEST. 316 00:17:47,280 --> 00:17:49,480 AND YOU MAY RECALL TESTING WAS 317 00:17:49,480 --> 00:17:52,720 NOT WIDELY AVAILABLE AND AT THAT 318 00:17:52,720 --> 00:17:54,760 POINT THE AVAILABILITY OF 319 00:17:54,760 --> 00:17:56,160 TESTING WAS -- IN THE UNITED 320 00:17:56,160 --> 00:17:56,880 STATES. 321 00:17:56,880 --> 00:17:59,360 SO WE DID HAVE TO TURN PEOPLE 322 00:17:59,360 --> 00:18:01,520 AWAY AT THAT POINT. 323 00:18:01,520 --> 00:18:04,160 BUT AS TESTING BECAME MORE 324 00:18:04,160 --> 00:18:07,560 WIDELY AVAILABLE WE DEVELOPED A 325 00:18:07,560 --> 00:18:08,480 DONOR PROCEDURE TREATMENT 326 00:18:08,480 --> 00:18:10,320 PROCEDURE. 327 00:18:10,320 --> 00:18:13,240 ONE IS DOES THE DONOR MEET 328 00:18:13,240 --> 00:18:17,400 ELIGIBILITY CRITERIA. 329 00:18:17,400 --> 00:18:19,840 AND WHAT EVER THE CURRENT 330 00:18:19,840 --> 00:18:23,120 CRITERIA WERE FOR COVID 331 00:18:23,120 --> 00:18:24,960 CONVALESCENT. 332 00:18:24,960 --> 00:18:26,760 THE PERIOD OF TIME ETC. 333 00:18:26,760 --> 00:18:29,520 WHETHER OR NOT THE DONOR HAD 334 00:18:29,520 --> 00:18:31,680 DETECTABLE SARS-CO- INDIVIDUAL 2 335 00:18:31,680 --> 00:18:35,680 AND IF IT MET THE THRESHOLDS. 336 00:18:35,680 --> 00:18:36,720 THAT WOULD DETERMINE WHETHER OR 337 00:18:36,720 --> 00:18:40,360 NOT WE WOULD INVITE DONORS TO 338 00:18:40,360 --> 00:18:42,600 COME BACK FOR FURTHER DONATIONS. 339 00:18:42,600 --> 00:18:43,600 *. 340 00:18:43,600 --> 00:18:45,120 *. 341 00:18:45,120 --> 00:18:48,120 OR PERHAPS TO DONATE OTHER BLOOD 342 00:18:48,120 --> 00:18:49,560 PRODUCTS AND WE COULD CONTINUE 343 00:18:49,560 --> 00:18:53,400 TO MONITOR THEM. 344 00:18:53,400 --> 00:18:56,760 THE TRANSFUSION SERVICE FOR 345 00:18:56,760 --> 00:18:58,440 LABORATORY WAS GREAT. 346 00:18:58,440 --> 00:19:01,080 A LOT OF LOGISTICAL WORK ON 347 00:19:01,080 --> 00:19:04,800 THEIR END TO MANAGE THE 348 00:19:04,800 --> 00:19:06,080 INVENTORY AND TO DISTRIBUTE IT 349 00:19:06,080 --> 00:19:08,600 TO THE FACILITIES WHEN THAT WAS 350 00:19:08,600 --> 00:19:10,200 OCCURRING. 351 00:19:10,200 --> 00:19:15,000 SO WHETHER OR NOT WE HAD FULL 352 00:19:15,000 --> 00:19:15,960 STORAGE CAPACITY WOULD DETERMINE 353 00:19:15,960 --> 00:19:19,520 IF WE COULD COLLECT MORE ETC. 354 00:19:19,520 --> 00:19:22,400 AND THEN THERE WERE SOME DONORS 355 00:19:22,400 --> 00:19:24,440 WHO WE THOUGHT WERE INTERESTING 356 00:19:24,440 --> 00:19:27,400 AND THUS THE ADVANTAGE OF HAVING 357 00:19:27,400 --> 00:19:29,920 THIS COLLECTION DONE UNDER A 358 00:19:29,920 --> 00:19:32,480 PROTOCOL -- WE INCLUDED A 359 00:19:32,480 --> 00:19:34,200 SECONDARY OBJECTIVE. 360 00:19:34,200 --> 00:19:37,800 THE MONITORING RESPONSES IN THIS 361 00:19:37,800 --> 00:19:40,120 COHORT OVER TIME AND THE DONORS 362 00:19:40,120 --> 00:19:42,040 WERE VERY MOTIVATED IN 363 00:19:42,040 --> 00:19:42,880 PARTICIPATING. 364 00:19:42,880 --> 00:19:46,880 WE ELECTED TO COMMUNICATE WITH 365 00:19:46,880 --> 00:19:51,160 THE DONORS WITH DISCLAIMERS 366 00:19:51,160 --> 00:19:53,280 STATING THAT THE TESTS WERE 367 00:19:53,280 --> 00:19:54,480 APPROVED UNDER EMERGENCY USE AND 368 00:19:54,480 --> 00:19:56,040 THE INFORMATION IS TO GUIDE 369 00:19:56,040 --> 00:19:57,520 WHETHER OR NOT YOU'RE ELIGIBLE 370 00:19:57,520 --> 00:20:00,560 FOR FURTHER PLASMA DONATIONS. 371 00:20:00,560 --> 00:20:02,680 BUT WE DID NOTICE THAT THE 372 00:20:02,680 --> 00:20:03,680 COMMUNICATION WAS AN IMPORTANT 373 00:20:03,680 --> 00:20:05,360 PART OF WHAT WE THINK 374 00:20:05,360 --> 00:20:06,480 CONTRIBUTED TO THE RETENTION IN 375 00:20:06,480 --> 00:20:08,200 THE PROGRAM AND THEY UNDERSTOOD 376 00:20:08,200 --> 00:20:11,400 THAT THIS WAS AN EVOLVING 377 00:20:11,400 --> 00:20:13,960 PROCESS AND THEY WERE EXCITED BY 378 00:20:13,960 --> 00:20:16,080 THE OPPORTUNITY TO PARTICIPATE 379 00:20:16,080 --> 00:20:19,480 IN WHAT THEY CONSIDERED THE 380 00:20:19,480 --> 00:20:20,280 CUTTING EDGE. 381 00:20:20,280 --> 00:20:23,240 AND WE'RE THANKFUL FOR THEIR 382 00:20:23,240 --> 00:20:28,600 PARTICIPATION AND EXCITEMENT. 383 00:20:28,600 --> 00:20:32,880 WE GENERALLY WERE EITHER 384 00:20:32,880 --> 00:20:36,280 MODIFYING PROCEDURES -- BUT RISK 385 00:20:36,280 --> 00:20:38,520 DID OCCUR AS WELL. 386 00:20:38,520 --> 00:20:43,320 WE ENROLLED 236 SUBJECTS. 387 00:20:43,320 --> 00:20:45,400 AGE 47 YEARS AND SIGNIFICANT 388 00:20:45,400 --> 00:20:46,240 CAUCASIAN MAJORITY. 389 00:20:46,240 --> 00:20:50,520 THAT IS TYPICAL OF THE ROUTINE 390 00:20:50,520 --> 00:20:52,920 DONOR POPULATION AS WELL AS THE 391 00:20:52,920 --> 00:20:55,160 U.S. GENERAL POPULATION AND THE 392 00:20:55,160 --> 00:20:56,960 BLOOD GROUPS ALSO REFLECTED THAT 393 00:20:56,960 --> 00:21:01,480 GROUP. 394 00:21:01,480 --> 00:21:04,680 WE INITIALLY COLLECTED PLASMA 395 00:21:04,680 --> 00:21:05,960 PARTICULARLY SINCE IN THE EARLY 396 00:21:05,960 --> 00:21:07,640 DAYS THERE WERE NO ASSAYS 397 00:21:07,640 --> 00:21:09,280 AVAILABLE AND IT WAS NOT CLEAR 398 00:21:09,280 --> 00:21:12,080 WHAT WE WOULD NEED TO HAVE TO 399 00:21:12,080 --> 00:21:16,160 QUALIFY PLASMA AS USABLE. 400 00:21:16,160 --> 00:21:20,240 WE WOULD PULL OUT WHAT WAS 401 00:21:20,240 --> 00:21:24,280 NEEDED AS THE CRITERIA EMERGED. 402 00:21:24,280 --> 00:21:29,880 WE STOPPED COLLECTIONS IN MAY 403 00:21:29,880 --> 00:21:30,120 MAY 2021. 404 00:21:30,120 --> 00:21:32,440 THE SAMPLES WERE FOR INITIAL 405 00:21:32,440 --> 00:21:34,440 EVALUATION OF THE DONOR SO WE 406 00:21:34,440 --> 00:21:37,000 WOULD DRAW SAMPLES -- IF YOU'RE 407 00:21:37,000 --> 00:21:41,080 A FEMALE DONOR -- 408 00:21:41,080 --> 00:21:42,280 [ AUDIO DIFFICULTIES ] 409 00:21:42,280 --> 00:21:44,920 OR DO YOU HAVE VERY LOW ANTIBODY 410 00:21:44,920 --> 00:21:50,480 LEVELS. 411 00:21:50,480 --> 00:22:08,680 WE WERE ABLE TO COLLECT OTHER -- 412 00:22:08,680 --> 00:22:08,800 -- 413 00:22:08,800 --> 00:22:10,080 [ AUDIO DIFFICULTIES ] 414 00:22:10,080 --> 00:22:12,760 WE COLLECTED 10% TO WHOLE BLOOD 415 00:22:12,760 --> 00:22:15,200 DONATIONS AND MANY OF THOSE 416 00:22:15,200 --> 00:22:17,720 DONORS CONTINUE TO DONATE WHOLE 417 00:22:17,720 --> 00:22:18,200 BLOOD. 418 00:22:18,200 --> 00:22:20,560 SO THOSE ARE NEW PEOPLE THAT WE 419 00:22:20,560 --> 00:22:22,520 HAVE IN THE POOL WHICH WE'RE 420 00:22:22,520 --> 00:22:27,120 THANKFUL. 421 00:22:27,120 --> 00:22:30,680 WE REENTERTAINED SAMPLES THAT 422 00:22:30,680 --> 00:22:34,400 COLLECTED FOR VALIDATION IN THE 423 00:22:34,400 --> 00:22:35,760 BIOREPOSITORY AND WE WERE ABLE 424 00:22:35,760 --> 00:22:37,280 TO COLLABORATE WITH GROUPS 425 00:22:37,280 --> 00:22:40,280 INSIDE AND OUTSIDE 426 00:22:40,280 --> 00:22:42,240 [ AUDIO DIFFICULTIES ] 427 00:22:42,240 --> 00:22:44,520 WHAT DID WE DO WITH THE PLASMA 428 00:22:44,520 --> 00:22:48,120 THAT WE COLLECTED? 429 00:22:48,120 --> 00:22:50,880 WE COLLECTED PLASMA FROM ABOUT 430 00:22:50,880 --> 00:22:54,000 163 OF THE DONORS AND COLLECTED 431 00:22:54,000 --> 00:22:56,200 ABOUT 800 UNITS OF PLASMA. 432 00:22:56,200 --> 00:22:58,400 THAT IS QUITE A LOT. 433 00:22:58,400 --> 00:22:59,720 SO THE INVENTORY MANAGEMENT 434 00:22:59,720 --> 00:23:01,720 WOULD LIKE TO THANK THEM FOR 435 00:23:01,720 --> 00:23:04,680 THEIR HARD WORK. 436 00:23:04,680 --> 00:23:07,680 AND EVEN THOUGH WE DISCONTINUED 437 00:23:07,680 --> 00:23:11,360 IN MAY OF 2021 WE HAD THE 438 00:23:11,360 --> 00:23:13,080 REPOSITORY OF PLASMA THAT WE 439 00:23:13,080 --> 00:23:15,400 HOPED WOULD BE USEFUL TO THE 440 00:23:15,400 --> 00:23:19,520 CLINICAL CENTER. 441 00:23:19,520 --> 00:23:26,360 SADLY -- THE CENTER DID NOT USE 442 00:23:26,360 --> 00:23:26,800 MUCH. 443 00:23:26,800 --> 00:23:30,080 WE HAVE ONLY HAD FOUR PATIENTS 444 00:23:30,080 --> 00:23:32,520 FOR WHICH CLINICIANS REQUESTED 445 00:23:32,520 --> 00:23:50,480 THE PLASMA. 446 00:23:50,480 --> 00:23:54,360 WE WERE ABLE TO PRACTICE DATA AT 447 00:23:54,360 --> 00:23:56,920 MEETINGS AND IN COLLABORATION 448 00:23:56,920 --> 00:24:01,200 WITH INFECTIOUS DISEASE. 449 00:24:01,200 --> 00:24:04,800 AND WE WERE ALSO TO SHARE 450 00:24:04,800 --> 00:24:07,880 SAMPLES OUTSIDE THE DTM. 451 00:24:07,880 --> 00:24:13,600 THE NOVEL RED CELL -- ASSAY FOR 452 00:24:13,600 --> 00:24:17,000 ANTIBODY COLLECTION WHICH WON AN 453 00:24:17,000 --> 00:24:21,080 AWARD. 454 00:24:21,080 --> 00:24:23,720 IT WAS REALLY -- JUST TO PROVIDE 455 00:24:23,720 --> 00:24:25,520 THE SAMPLES AND THE DATA FROM 456 00:24:25,520 --> 00:24:27,440 THE DONORS WE HAD COLLECTED BUT 457 00:24:27,440 --> 00:24:29,680 HAVING THAT REPOSITORY AND THE 458 00:24:29,680 --> 00:24:32,440 DETAIL DONOR HISTORY WAS HELPFUL 459 00:24:32,440 --> 00:24:35,000 IN SOME OF THESE COLLABORATIONS. 460 00:24:35,000 --> 00:24:37,000 SO THAT WAS ONE OF THE BENEFITS 461 00:24:37,000 --> 00:24:46,080 OF STARTING THIS PROGRAM. 462 00:24:46,080 --> 00:24:51,840 ONE OF MY REGRETS WAS THAT WE 463 00:24:51,840 --> 00:24:54,280 WERE NOT ABLE TO ESTABLISH A 464 00:24:54,280 --> 00:24:59,960 COLLABORATION -- THE DATA FROM 465 00:24:59,960 --> 00:25:04,080 THE EAP -- 466 00:25:04,080 --> 00:25:07,520 [ AUDIO DIFFICULTIES ] 467 00:25:07,520 --> 00:25:10,720 INDICATED THAT SEVERE ADVERSE 468 00:25:10,720 --> 00:25:14,120 EVENTS WERE LOW INCLUDING 469 00:25:14,120 --> 00:25:14,400 REACTIONS 470 00:25:14,400 --> 00:25:15,360 [ INDISCERNIBLE ] 471 00:25:15,360 --> 00:25:18,360 THEY CONCLUDED AS HAVE MANY 472 00:25:18,360 --> 00:25:20,520 OTHERS CONCLUDED THAT 473 00:25:20,520 --> 00:25:23,320 CONVALESCENT PLASMA IS SAFE OR 474 00:25:23,320 --> 00:25:27,680 NO MORE DANGEROUS THAN ROUTINE 475 00:25:27,680 --> 00:25:29,320 PLASMA TRANSFUSION. 476 00:25:29,320 --> 00:25:31,240 THE COMMUNITY HAS INTERPRETED 477 00:25:31,240 --> 00:25:33,320 THE STUDIES THAT HAVE BEEN 478 00:25:33,320 --> 00:25:35,120 CONDUCTED TO INDICATE THAT THERE 479 00:25:35,120 --> 00:25:38,480 IS NO SIGNIFICANT BENEFIT OF CCP 480 00:25:38,480 --> 00:25:41,720 IN THE GROUPS THAT WERE 481 00:25:41,720 --> 00:25:42,520 ANALYZED. 482 00:25:42,520 --> 00:25:43,760 AND THIS IS REFLECTED IN THE 483 00:25:43,760 --> 00:25:45,880 BIDE LINES. 484 00:25:45,880 --> 00:25:48,920 -- GUIDELINES. 485 00:25:48,920 --> 00:25:51,040 * AND THERE HAS BEEN SOME 486 00:25:51,040 --> 00:25:52,600 ARGUMENT MADE THAT THERE MIGHT 487 00:25:52,600 --> 00:25:56,480 BE SOME BENEFIT IN SOME 488 00:25:56,480 --> 00:25:58,000 POPULATIONS PERHAPS OLDER 489 00:25:58,000 --> 00:26:03,280 ADULTS. 490 00:26:03,280 --> 00:26:12,480 THERI WON'T ATTEMPT TO COVER ALL OF 491 00:26:12,480 --> 00:26:15,320 THE STUDIES THAT HAVE BEEN DONE. 492 00:26:15,320 --> 00:26:20,280 AS SOMEONE INDICATED IN A RECENT 493 00:26:20,280 --> 00:26:21,640 INTERVIEW THERE HAVE BEEN TWO 494 00:26:21,640 --> 00:26:23,520 TRIALS LOOKING AT CONVALESCENT 495 00:26:23,520 --> 00:26:27,840 PLASMA IN THE LAST TWO YEARS 496 00:26:27,840 --> 00:26:29,240 THERE HAVE BEEN 25 COMPLETED. 497 00:26:29,240 --> 00:26:32,720 SO THAT GIVES YOU AN IDEA OF HOW 498 00:26:32,720 --> 00:26:47,880 MANY HAVE BEEN COMPLETED. 499 00:26:47,880 --> 00:26:51,680 HOWEVER THERE ARE SOME WHO ARGUE 500 00:26:51,680 --> 00:26:54,640 THAT VACCINATED DONORS MIGHT 501 00:26:54,640 --> 00:26:54,880 PROVIDE 502 00:26:54,880 --> 00:26:55,520 [ INDISCERNIBLE ] 503 00:26:55,520 --> 00:26:57,440 THUS FAR SO WE SHOULD NOT MISS 504 00:26:57,440 --> 00:26:58,720 THE OPPORTUNITY TO COLLECT WHAT 505 00:26:58,720 --> 00:27:02,040 MIGHT BE THE BEST PRODUCT 506 00:27:02,040 --> 00:27:03,120 AVAILABLE US TO. 507 00:27:03,120 --> 00:27:05,280 I'VE INCLUDED A SCREEN SHOT HERE 508 00:27:05,280 --> 00:27:07,240 FOR DETERMINING WHETHER OR NOT 509 00:27:07,240 --> 00:27:10,240 THE VACCINATED OR UNVACCINATED 510 00:27:10,240 --> 00:27:12,480 PLASMA DONORS COULD BE INCLUDED 511 00:27:12,480 --> 00:27:15,440 FOR CCP DONATION TO GIVE YOU AN 512 00:27:15,440 --> 00:27:16,880 IDEA OF THE COMPLEXITY OF THE 513 00:27:16,880 --> 00:27:18,560 QUESTION AND THE MAJOR QUESTION 514 00:27:18,560 --> 00:27:20,680 IS WHETHER OR NOT THE PLASMA 515 00:27:20,680 --> 00:27:22,880 THAT WE COLLECTED WOULD BE 516 00:27:22,880 --> 00:27:26,880 EFFECTIVE AGAINST ONE OF THE 517 00:27:26,880 --> 00:27:29,680 CURRENT SARS-CoV-2 VARIANTS. 518 00:27:29,680 --> 00:27:32,880 THERE ARE STILL ONGOING TRIALS 519 00:27:32,880 --> 00:27:36,000 NOT PRY MAYBELY IN THE UNITED 520 00:27:36,000 --> 00:27:38,040 STATES BUT IN THE * REST OF THE 521 00:27:38,040 --> 00:27:38,480 WORLD. 522 00:27:38,480 --> 00:27:40,560 THERE ARE OPEN STUDIES STILL IN 523 00:27:40,560 --> 00:27:44,080 BRAZIL AND ITALY. 524 00:27:44,080 --> 00:27:48,160 I'M GOING TO CLOSE BY LISTING 525 00:27:48,160 --> 00:27:50,240 WHAT I CONSIDER THE LESSONS I 526 00:27:50,240 --> 00:27:53,240 LEARNED. 527 00:27:53,240 --> 00:27:55,080 THE DTM 528 00:27:55,080 --> 00:27:56,280 [ INDISCERNIBLE ] 529 00:27:56,280 --> 00:27:59,760 WAS ABLE TO RAPIDLY MOBILIZE A 530 00:27:59,760 --> 00:28:01,880 POTENTIALLY THERAPEUTIC RESOURCE 531 00:28:01,880 --> 00:28:03,880 IN A TIME OF GREAT UNCERTAINTY 532 00:28:03,880 --> 00:28:06,880 AND WE WERE THANKFUL FOR THE 533 00:28:06,880 --> 00:28:08,680 COLLABORATION OF THE TRANSFUSION 534 00:28:08,680 --> 00:28:09,840 SERVICE LABORATORY MAKING IT 535 00:28:09,840 --> 00:28:11,280 POSSIBLE. 536 00:28:11,280 --> 00:28:14,280 THIS REQUIRED EXTENSIVE 537 00:28:14,280 --> 00:28:15,640 COLLABORATION BETWEEN 538 00:28:15,640 --> 00:28:16,920 TELEWORKING AND ON-SITE 539 00:28:16,920 --> 00:28:18,120 PERSONNEL. 540 00:28:18,120 --> 00:28:22,080 AND SIGNIFICANT ADAPTABILITY 541 00:28:22,080 --> 00:28:30,160 AMIDST REGULATORY CHANGES. 542 00:28:30,160 --> 00:28:30,880 [ INDISCERNIBLE ] 543 00:28:30,880 --> 00:28:32,920 AND WE ALSO WERE HAPPY TO 544 00:28:32,920 --> 00:28:36,320 WELCOME A NEW GROUP OF MOAT 545 00:28:36,320 --> 00:28:40,200 INDICATED DONORS. 546 00:28:40,200 --> 00:28:44,680 AND THIS ENTIRE EXPERIENCE TO ME 547 00:28:44,680 --> 00:28:48,200 EMPHASIZED THE IMPORTANCE OF 548 00:28:48,200 --> 00:28:56,400 COMMUNICATION. 549 00:29:00,680 --> 00:29:30,840 I WOULD LIKE TO THANK -- AND 550 00:29:30,840 --> 00:29:37,640 FINALLY OUR NIH BLOOD AND PLASMA CLASS 551 00:29:37,640 --> 00:29:38,360 -- PLASMA DONORS. 552 00:29:38,360 --> 00:29:40,400 THANK YOU SO MUCH FOR HAVING ME 553 00:29:40,400 --> 00:29:41,600 TODAY PRESENTING TOGETHER WITH 554 00:29:41,600 --> 00:29:44,000 DR. WEST. 555 00:29:44,000 --> 00:29:45,760 I HAVE NOTHING TO DISCLOSE. 556 00:29:45,760 --> 00:29:48,560 THE VIEWS EXPRESSED ARE MY OWN 557 00:29:48,560 --> 00:29:51,640 AND DO NOT REFLECT THE NATIONAL 558 00:29:51,640 --> 00:29:53,560 STUDENT OF HEALTH OR HUMAN 559 00:29:53,560 --> 00:29:55,760 SERVICES OR THE U.S. FEDERAL 560 00:29:55,760 --> 00:29:56,400 GOVERNMENT. 561 00:29:56,400 --> 00:29:58,280 THOSE ARE THE OBJECTIVES OF MY 562 00:29:58,280 --> 00:29:58,760 PRESENTATION. 563 00:29:58,760 --> 00:30:00,640 WE'RE GOING TO BRIEFLY GO 564 00:30:00,640 --> 00:30:06,240 THROUGH THE LANDSCAPE OF 565 00:30:06,240 --> 00:30:10,480 COVID-19 SEROLOGICAL TESTS. 566 00:30:10,480 --> 00:30:12,720 THE POLICY CHANGES. 567 00:30:12,720 --> 00:30:21,960 OUR EXPERIENCE, VERY INTERESTING 568 00:30:21,960 --> 00:30:28,160 DATA -- I'M SHOWING THIS BECAUSE 569 00:30:28,160 --> 00:30:30,800 IN A FEW DAYS IT'S GOING TO BE 570 00:30:30,800 --> 00:30:36,760 TWO YEARS SINCE IT WAS DECLARED 571 00:30:36,760 --> 00:30:37,640 A PANDEMIC. 572 00:30:37,640 --> 00:30:39,400 REPORTING GLOBALLY THE NUMBER OF 573 00:30:39,400 --> 00:30:42,120 POSITIVE CASES IN LIGHT BLUE. 574 00:30:42,120 --> 00:30:47,960 THAT IS IN ORANGE THE NUMBER OF 575 00:30:47,960 --> 00:30:49,160 VACCINES AND YOU CAN SEE THE 576 00:30:49,160 --> 00:30:51,640 NUMBER OF CONFIRMED CASES IN THE 577 00:30:51,640 --> 00:30:53,120 U.S. 578 00:30:53,120 --> 00:30:54,880 STILL SCARY AND REALLY 579 00:30:54,880 --> 00:30:58,680 UPSETTING. 580 00:30:58,680 --> 00:31:10,600 A BRIEF REVIEW ON -- TESTS. 581 00:31:10,600 --> 00:31:20,360 IT'S COMPOSED BY PROTEINS. 582 00:31:20,360 --> 00:31:27,680 OF THE FOUR MAJOR STRUCTURES -- 583 00:31:27,680 --> 00:31:35,440 THE PROTEIN "S" AND THE "N" -- 584 00:31:35,440 --> 00:31:38,320 BOTH HAVE BEEN WIDELY USED AS 585 00:31:38,320 --> 00:31:41,520 TARGET ANTIGEN FOR SEROLOGICAL 586 00:31:41,520 --> 00:31:41,720 ASSAY. 587 00:31:41,720 --> 00:31:47,360 IF A PERSON TEST POSITIVE 588 00:31:47,360 --> 00:31:49,240 TYPICALLY -- MEASURABLE 589 00:31:49,240 --> 00:31:51,520 ANTIBODIES AROUND THE FIRST WEEK 590 00:31:51,520 --> 00:31:57,280 I WOULD SAY THE FIRST 7-14 DAYS 591 00:31:57,280 --> 00:32:01,240 AND BY THE WEEK THE THIRD WEEK 592 00:32:01,240 --> 00:32:03,360 MOST PERSONSES THAT TEST 593 00:32:03,360 --> 00:32:07,920 POSITIVE -- SPECIFICALLY IGM OR 594 00:32:07,920 --> 00:32:10,600 ANTIS OR ANTIN -- WITHIN ONE 595 00:32:10,600 --> 00:32:11,760 WEEK AND THEY CONTINUE TO 596 00:32:11,760 --> 00:32:24,960 INCREASE OVER TIME. 597 00:32:24,960 --> 00:32:28,520 THE SENSITIVE OF DETECTION 598 00:32:28,520 --> 00:32:33,160 FASHION USING ANTIGEN ASSAY THEY 599 00:32:33,160 --> 00:32:35,320 WILL DECREASE. 600 00:32:35,320 --> 00:32:38,960 SPECIFICALLY THE SARS-CoV-2 601 00:32:38,960 --> 00:32:40,440 ANTIBODIES MAY PERSIST FOR 602 00:32:40,440 --> 00:32:44,040 MONTHS AND HOPEFULLY FOR YEARS. 603 00:32:44,040 --> 00:32:50,280 RIGHT NOW THERE ARE 85 604 00:32:50,280 --> 00:32:54,280 INDIVIDUAL EUA REDUCED FOR SEAR 605 00:32:54,280 --> 00:32:58,000 LOGICAL TESTS. 606 00:32:58,000 --> 00:33:24,680 TWO ARE NEUTRALIZING. 607 00:33:24,680 --> 00:33:33,280 ANTIBODY ISO TYPES -- AND THE 608 00:33:33,280 --> 00:33:36,680 RESULTS FORMAT CAN BE 609 00:33:36,680 --> 00:33:43,280 QUALITATIVE. 610 00:33:43,280 --> 00:33:44,760 I'M SHOWING THIS TABLE. 611 00:33:44,760 --> 00:33:46,920 FROM THE CDC WEBSITE BECAUSE 612 00:33:46,920 --> 00:33:55,600 THIS IS A FAIRLY USABLE TOOL. 613 00:33:55,600 --> 00:33:57,160 MOST OF THE POPULATION IN THE 614 00:33:57,160 --> 00:33:58,520 U.S. RIGHT NOW RECEIVED THE 615 00:33:58,520 --> 00:34:04,040 VACCINE AND THE VACCINE HAS BEEN 616 00:34:04,040 --> 00:34:05,160 BILLED SPECIFICALLY FOR THE 617 00:34:05,160 --> 00:34:06,760 PROTEIN. 618 00:34:06,760 --> 00:34:11,480 WHEN WE PERFORM A TEST WE CANNOT 619 00:34:11,480 --> 00:34:13,600 DISTINGUISH IF THAT IS FREE OF 620 00:34:13,600 --> 00:34:14,840 INFECTION. 621 00:34:14,840 --> 00:34:17,320 SO HAVING AVAILABLE ALSO 622 00:34:17,320 --> 00:34:19,600 ANTIBODY RESULTS CAN HELP 623 00:34:19,600 --> 00:34:20,960 DISTINGUISH THE SITUATION. 624 00:34:20,960 --> 00:34:23,680 EITHER IF WE'RE LOOKING AT 625 00:34:23,680 --> 00:34:26,560 VACCINATED OR UNVACCINATED 626 00:34:26,560 --> 00:34:28,040 STATUS OR UNKNOWN. 627 00:34:28,040 --> 00:34:30,560 IT'S IMPORTANT TO HAVE THESE 628 00:34:30,560 --> 00:34:30,760 TOOLS. 629 00:34:30,760 --> 00:34:35,200 BUT AND THIS TABLE IS HELPING IN 630 00:34:35,200 --> 00:34:36,760 AGAIN THAT WE RECEIVED SO MANY 631 00:34:36,760 --> 00:34:37,160 QUESTIONS. 632 00:34:37,160 --> 00:34:41,760 I THINK I'VE BEEN INFECTED. 633 00:34:41,760 --> 00:34:44,520 CAN I HAVE THE SEROLOGY TEST? 634 00:34:44,520 --> 00:34:46,360 IT'S GOING TO BE POSITIVE AND 635 00:34:46,360 --> 00:34:47,960 IT'S NOT GOING TO TELL YOU 636 00:34:47,960 --> 00:34:48,400 ANYTHING. 637 00:34:48,400 --> 00:34:50,960 BUT THIS TABLE IS SIMPLE TO READ 638 00:34:50,960 --> 00:34:52,840 AND VERY HELPFUL TOOL. 639 00:34:52,840 --> 00:34:56,120 WE NEED TO BE CAREFUL IN 640 00:34:56,120 --> 00:34:58,160 INTERPRETING THE RESULTS BECAUSE 641 00:34:58,160 --> 00:35:02,480 THERE ARE PEOPLE THAT DON'T 642 00:35:02,480 --> 00:35:06,560 DON'T HAVE ANTIBODY AS ALL. 643 00:35:06,560 --> 00:35:11,720 WE DON'T KNOW WHEN AND IF THE 644 00:35:11,720 --> 00:35:12,960 ANTIBODIES WILL WANE OVER TIME. 645 00:35:12,960 --> 00:35:14,480 SO THE FACT THAT THE PERSON CAN 646 00:35:14,480 --> 00:35:18,760 BE NEGATIVE FOR -- N DOES NOT 647 00:35:18,760 --> 00:35:21,160 MEAN THAT THE PERSON WAS 648 00:35:21,160 --> 00:35:21,560 INFECTED BEFORE. 649 00:35:21,560 --> 00:35:24,360 SO WE NEED TO BE CAREFUL IN 650 00:35:24,360 --> 00:35:26,160 INTERPRETING BUT STILL A GOOD 651 00:35:26,160 --> 00:35:27,120 TOOL. 652 00:35:27,120 --> 00:35:29,520 LET'S LOOK AT WHAT HAPPENED 653 00:35:29,520 --> 00:35:34,240 DURING THE THESE PAST TWO YEARS 654 00:35:34,240 --> 00:35:36,240 AND SPECIFICALLY AT THE 655 00:35:36,240 --> 00:35:38,160 CONVALESCENT PLASMA 656 00:35:38,160 --> 00:35:39,800 QUALIFICATIONS UNDER THE 657 00:35:39,800 --> 00:35:41,240 CONSTANT CHANGE OF THE FDA 658 00:35:41,240 --> 00:35:42,360 POLICIES. 659 00:35:42,360 --> 00:35:43,720 THERE ARE SEVERAL APPROACHES 660 00:35:43,720 --> 00:35:51,720 THAT HAVE BEEN USED FOR 661 00:35:51,720 --> 00:35:53,400 QUALIFICATION. 662 00:35:53,400 --> 00:35:55,160 THERE WERE NO AVAILABLE TESTS AT 663 00:35:55,160 --> 00:35:56,400 ALL. 664 00:35:56,400 --> 00:35:59,840 AND IF I LOOK BACK IT SEEMS LIKE 665 00:35:59,840 --> 00:36:01,480 20 YEARS HAS PASSED BUT IT'S 666 00:36:01,480 --> 00:36:02,680 ONLY TWO YEARS. 667 00:36:02,680 --> 00:36:03,760 AND THERE WAS NOTHING. 668 00:36:03,760 --> 00:36:08,760 SO THE FDA WAS SAYING COLLECT 669 00:36:08,760 --> 00:36:10,680 PLASMA WHEN ANY TEST WOULD BE 670 00:36:10,680 --> 00:36:12,680 AVAILABLE WE CAN GO BACK AND 671 00:36:12,680 --> 00:36:17,160 CHECK. 672 00:36:17,160 --> 00:36:22,400 ANTIBODIES CAN BE MEASURED. 673 00:36:22,400 --> 00:36:28,000 IT MEASURES BINDING USING ELISA 674 00:36:28,000 --> 00:36:33,800 OR CHLIA. 675 00:36:33,800 --> 00:36:37,280 THE MEASUREMENT IS GENERALLY 676 00:36:37,280 --> 00:36:38,040 QUANTITATIVE. 677 00:36:38,040 --> 00:36:41,680 YOU CAN HAVE THE KIND OF 678 00:36:41,680 --> 00:36:43,800 QUANTIFICATION OF ANTIBODIES. 679 00:36:43,800 --> 00:36:47,680 BUT CANNOT BE DEFINED AS A 680 00:36:47,680 --> 00:36:53,920 TIGHTER. 681 00:36:53,920 --> 00:36:55,960 THOSE ARE THE ONE THAT'S CAN BE 682 00:36:55,960 --> 00:36:56,120 -- 683 00:36:56,120 --> 00:37:09,840 [ INDISCERNIBLE ] 684 00:37:09,840 --> 00:37:12,160 THEY REQUIRE SPECIALIZED 685 00:37:12,160 --> 00:37:14,360 EXPERTISE AND PERSONNEL. 686 00:37:14,360 --> 00:37:16,960 THEY ALSO ARE VERY DIFFICULT TO 687 00:37:16,960 --> 00:37:20,360 -- ACROSS DIFFERENT LOGISTICALLY 688 00:37:20,360 --> 00:37:20,800 COMPLEX. 689 00:37:20,800 --> 00:37:25,120 AND THEY ARE TIME-CONSUMING. 690 00:37:25,120 --> 00:37:27,000 SOME OF THEM NOW FIVE DAYS BUT 691 00:37:27,000 --> 00:37:29,920 STILL IT'S A LONG TIME. 692 00:37:29,920 --> 00:37:32,920 SEROLOGICAL BINDING ASSAY -- 693 00:37:32,920 --> 00:37:35,320 THESE ARE EASIER TO PERFORM. 694 00:37:35,320 --> 00:37:37,320 THEY CAN BE AUTOMATED. 695 00:37:37,320 --> 00:37:40,520 THE MOST USED TO QUALIFY THE 696 00:37:40,520 --> 00:37:41,840 CONVALESCENT PLASMA UNIT. 697 00:37:41,840 --> 00:37:44,040 I DON'T WANT TO GO THROUGH IN 698 00:37:44,040 --> 00:37:45,800 DETAIL ON THIS SLIDE. 699 00:37:45,800 --> 00:37:48,120 AS DR. WEST GAVE US ALREADY -- 700 00:37:48,120 --> 00:37:50,000 IN DETAIL OVERVIEW OF THIS. 701 00:37:50,000 --> 00:37:51,880 I JUST WANT TO POINT OUT IN 702 00:37:51,880 --> 00:37:54,400 TERMS OF TESTING REQUIREMENT 703 00:37:54,400 --> 00:37:57,520 FROM FDA DURING THESE PAST TWO 704 00:37:57,520 --> 00:37:58,160 YEARS. 705 00:37:58,160 --> 00:38:00,520 WHAT HAPPENED WAS AGAIN AT THE 706 00:38:00,520 --> 00:38:04,480 BEGINNING WHEN -- THE HOSPITAL 707 00:38:04,480 --> 00:38:07,720 WAS COLLECTING PLASMA THE FDA 708 00:38:07,720 --> 00:38:09,360 WAS SUGGESTING RECOMMENDING TO 709 00:38:09,360 --> 00:38:11,800 TEST THE UNIT WAS NOT REQUIRED. 710 00:38:11,800 --> 00:38:13,480 AND AGAIN BACK THEN THERE WAS 711 00:38:13,480 --> 00:38:15,680 NOTHING AVAILABLE. 712 00:38:15,680 --> 00:38:19,320 SO THE FIRST TEST THAT WAS 713 00:38:19,320 --> 00:38:24,160 RELEASED AND RECEIVED THE EUA 714 00:38:24,160 --> 00:38:27,600 WAS THE AUTO DIAGNOSTIC. 715 00:38:27,600 --> 00:38:29,160 AND THAT HAPPENED BASICALLY IN 716 00:38:29,160 --> 00:38:29,720 APRIL. 717 00:38:29,720 --> 00:38:32,320 AFTER A FEW MONTHS FROM MAYBE TO 718 00:38:32,320 --> 00:38:35,320 AUGUST MANY DATA WERE GENERATED 719 00:38:35,320 --> 00:38:40,480 ON THE CONVALESCENT PLASMA UNIT. 720 00:38:40,480 --> 00:38:43,120 A CROSS LABORATORY COMPARISON 721 00:38:43,120 --> 00:38:47,360 SHOWED THAT SARS-CO- INDIVIDUAL 722 00:38:47,360 --> 00:38:49,800 2IG SPECIFIC TEST WAS 723 00:38:49,800 --> 00:38:52,120 CORRELATING WITH THIS 724 00:38:52,120 --> 00:38:56,200 NEUTRALIZING ASSAY THAT WAS DONE 725 00:38:56,200 --> 00:38:58,960 FROM THE INSTITUTE IN UK AND 726 00:38:58,960 --> 00:39:02,600 COMPARING THESE TWO SET OF DATA 727 00:39:02,600 --> 00:39:04,640 THERE WAS CLEAR THERE WAS A 728 00:39:04,640 --> 00:39:09,240 VALUE FOR THE AUTO DIAGNOSTIC 729 00:39:09,240 --> 00:39:11,600 TEST. 730 00:39:11,600 --> 00:39:14,200 THERE WAS INDICATED THAT IT WAS 731 00:39:14,200 --> 00:39:19,600 A GOOD MATCH BETWEEN IG AND 732 00:39:19,600 --> 00:39:23,240 NEUTRALIZING LEVEL SO FDA 733 00:39:23,240 --> 00:39:24,480 RELEASED THIS NEW REQUIREMENT 734 00:39:24,480 --> 00:39:26,920 WHERE THE UNITS THE CONVALESCENT 735 00:39:26,920 --> 00:39:28,520 PLASMA UNIT THAT WAS COLLECTED 736 00:39:28,520 --> 00:39:33,400 THEY NEEDED TO BE QUALIFIED AS 737 00:39:33,400 --> 00:39:39,400 LOW TIGHTER AND HIGH TIGHTER. 738 00:39:39,400 --> 00:39:41,720 BUT THEN AGAIN IN FEBRUARY 739 00:39:41,720 --> 00:39:43,040 BECAUSE MORE AND MORE 740 00:39:43,040 --> 00:39:45,480 SATISFACTORY LOGICAL ASSAY WERE 741 00:39:45,480 --> 00:39:47,320 RECEIVED AND MORE DATA WAS 742 00:39:47,320 --> 00:39:50,760 PRODUCED AND THERE WAS A BIG 743 00:39:50,760 --> 00:39:54,240 COLLABORATION -- THIS VALUE WAS 744 00:39:54,240 --> 00:39:56,280 CHANGED AND ALSO THERE WAS NO 745 00:39:56,280 --> 00:39:58,800 LOW AND HIGH TIGHTER ANY MORE. 746 00:39:58,800 --> 00:40:01,560 THEY NEEDED TO BE JUST CALLED 747 00:40:01,560 --> 00:40:04,720 HIGH TIGHTER AND BY 748 00:40:04,720 --> 00:40:07,000 DECEMBER 2021 ALL COVID-19 749 00:40:07,000 --> 00:40:11,720 CONVALESCENT PLASMA TRANS FUSED 750 00:40:11,720 --> 00:40:15,280 WAS QUALIFIED WITH QUANTITATIVE 751 00:40:15,280 --> 00:40:16,640 ASSAY. 752 00:40:16,640 --> 00:40:19,040 THOSE ARE THE ASSAY -- THE NINE 753 00:40:19,040 --> 00:40:21,800 THAT RECEIVED THE EUA FROM THE 754 00:40:21,800 --> 00:40:24,360 FDA THAT WAS APPROVED TO QUALIFY 755 00:40:24,360 --> 00:40:27,720 THE PLASMA FOR CLINICAL USE IN 756 00:40:27,720 --> 00:40:29,080 HOSPITALIZED PATIENTS AND THEY 757 00:40:29,080 --> 00:40:31,840 NEED TO BE LABELED AS HIGH 758 00:40:31,840 --> 00:40:32,520 TIGHT. 759 00:40:32,520 --> 00:40:35,840 AS YOU CAN SEE EACH SYSTEM IS 760 00:40:35,840 --> 00:40:38,520 REPORTING RESULTS IN UNIQUE 761 00:40:38,520 --> 00:40:40,160 UNITS AND HERE IT IS REPORTED 762 00:40:40,160 --> 00:40:43,600 THE VALUE THAT IS NEEDED TO 763 00:40:43,600 --> 00:40:45,680 QUALIFY THE CONVALESCENT PLASMA 764 00:40:45,680 --> 00:40:47,320 UNIT ACCORDING WITH THAT TEST. 765 00:40:47,320 --> 00:40:49,320 IN OUR CASE WE'VE BEEN NOW 766 00:40:49,320 --> 00:40:52,720 QUALIFYING THE PLASMA, THE 767 00:40:52,720 --> 00:40:56,120 REMAINING ONE WITH AUTO 768 00:40:56,120 --> 00:40:59,880 QUANTITATIVE IGG ASSAY. 769 00:40:59,880 --> 00:41:01,760 LET'S SEE HOW THIS WAS CHANGING 770 00:41:01,760 --> 00:41:03,880 OUR EVERY DAY WORKFLOW. 771 00:41:03,880 --> 00:41:06,600 BECAUSE I THINK THAT IS THE MOST 772 00:41:06,600 --> 00:41:09,120 IMPORTANT PART. 773 00:41:09,120 --> 00:41:11,320 I WILL RECALL THIS INTERESTING 774 00:41:11,320 --> 00:41:14,480 STORY SO DR. WEST AGAIN SHE 775 00:41:14,480 --> 00:41:16,680 DECIDED TO IMPLEMENT THE 776 00:41:16,680 --> 00:41:19,320 COLLECTION AND SHE CALLED ME. 777 00:41:19,320 --> 00:41:22,520 I'M WRITING THE PROTOCOL BUT I'M 778 00:41:22,520 --> 00:41:24,200 NOT SURE HOW WE'RE GOING TO 779 00:41:24,200 --> 00:41:26,560 QUALIFY THIS UNIT. 780 00:41:26,560 --> 00:41:28,920 WAS ALREADY KNOWN THAT WE DON'T 781 00:41:28,920 --> 00:41:31,440 KNOW IF THIS PATIENT THIS DONOR 782 00:41:31,440 --> 00:41:34,320 THAT THEY GOT INFECTED. 783 00:41:34,320 --> 00:41:35,840 THEY DEVELOPED ANTIBODIES. 784 00:41:35,840 --> 00:41:37,480 WE KNOW NOTHING ABOUT THAT. 785 00:41:37,480 --> 00:41:40,040 SO CAN YOU PLEASE HELP ME IN 786 00:41:40,040 --> 00:41:41,800 QUALIFYING THE UNIT? 787 00:41:41,800 --> 00:41:42,840 AND OF COURSE I SAID SURE. 788 00:41:42,840 --> 00:41:45,600 I WILL HELP YOU BUT IN REALITY I 789 00:41:45,600 --> 00:41:46,880 KNEW THERE WAS NOTHING THAT I 790 00:41:46,880 --> 00:41:49,920 COULD DO AT THAT MOMENT. 791 00:41:49,920 --> 00:41:52,000 SO WE STARTED LOOKING AROUND. 792 00:41:52,000 --> 00:41:56,400 WE STARTED CONTACTING OUR THE 793 00:41:56,400 --> 00:42:00,480 COMPANY -- PROVIDING ALL OF THE 794 00:42:00,480 --> 00:42:03,760 KEYS FOR OUR DIAGNOSTIC LAB AND 795 00:42:03,760 --> 00:42:05,240 THERE WAS ABSOLUTELY NOTHING. 796 00:42:05,240 --> 00:42:08,880 SO WE DECIDED OKAY WE'RE GOING 797 00:42:08,880 --> 00:42:11,440 TO TRUST AND DEVELOP IN OUR OWN 798 00:42:11,440 --> 00:42:13,360 TEST WE'RE GOING TO DEVELOP A 799 00:42:13,360 --> 00:42:15,320 LAB BASED TEST AND BY THE TIME 800 00:42:15,320 --> 00:42:19,080 WE WERE READY TO DO THAT FDA 801 00:42:19,080 --> 00:42:21,640 GRANTED THE FIRST EUA TO THE 802 00:42:21,640 --> 00:42:24,640 AUTO DIAGNOSTIC AND WE WERE SO 803 00:42:24,640 --> 00:42:28,880 LUCKY BECAUSE THE -- THIS IS THE 804 00:42:28,880 --> 00:42:34,320 SYSTEM THAT WE USED. 805 00:42:34,320 --> 00:42:36,320 WE'VE IMPLEMENTED FOUR 806 00:42:36,320 --> 00:42:53,520 SEROLOGICAL ASSAYS. 807 00:42:53,520 --> 00:42:59,080 AND ALSO MOST IMPORTANTLY A TRUE 808 00:42:59,080 --> 00:43:02,920 -- COLLABORATION WE WERE ALL OF 809 00:43:02,920 --> 00:43:07,640 US ALL OF THE SCIENTISTS WE WERE 810 00:43:07,640 --> 00:43:13,240 ABLE TO FIND THIS GROUP THAT IS 811 00:43:13,240 --> 00:43:17,000 IN FREDERICK THAT WAS WILLING TO 812 00:43:17,000 --> 00:43:18,720 TEST FOR NEUTRALIZING 813 00:43:18,720 --> 00:43:21,520 ANTIBODIES. 814 00:43:21,520 --> 00:43:25,400 JUST GIVING ANOTHER VIEW OF THE 815 00:43:25,400 --> 00:43:28,160 IGG. 816 00:43:28,160 --> 00:43:31,000 THE TECHNIQUE THAT INVOLVES TWO 817 00:43:31,000 --> 00:43:31,880 STAGE REACTION. 818 00:43:31,880 --> 00:43:34,320 IN THE FIRST STAGE WE HAVE 819 00:43:34,320 --> 00:43:36,040 ANTIBODY TO SARS THAT ARE 820 00:43:36,040 --> 00:43:38,200 PRESENT IN OUR SAMPLES THAT ARE 821 00:43:38,200 --> 00:43:43,120 BINDING TO SARS-CO- VERY 2 SPIKE 822 00:43:43,120 --> 00:43:46,720 PROTEIN AND IN THE SECOND STAGE 823 00:43:46,720 --> 00:44:01,320 LABELED MONO CLON -- MONOCLONAL -- WE ADD 824 00:44:01,320 --> 00:44:05,200 A SUB STRAIGHT. 825 00:44:05,200 --> 00:44:06,640 AND THAT SIGNAL CAN BE 826 00:44:06,640 --> 00:44:10,600 TRANSFORMED INTO A NUMERICAL 827 00:44:10,600 --> 00:44:12,480 VALUE. 828 00:44:12,480 --> 00:44:15,000 THIS IS GIVING RESULTS IN THE 829 00:44:15,000 --> 00:44:16,520 FORM OF SIGNIFICANT OF VALUE. 830 00:44:16,520 --> 00:44:20,160 IF THE VALUE IS BELOW ONE THE 831 00:44:20,160 --> 00:44:21,920 TEST IS -- REACTIVE. 832 00:44:21,920 --> 00:44:25,680 IF IT'S GREAT THEN THE TESTING 833 00:44:25,680 --> 00:44:29,800 CALLED REACTIVE. 834 00:44:29,800 --> 00:44:32,120 THIS IS JUST TO REFRESH THE 835 00:44:32,120 --> 00:44:36,320 MEMORY. 836 00:44:36,320 --> 00:44:42,320 AND THEN IN APRIL 21 FDA SORRY 837 00:44:42,320 --> 00:44:45,880 IN APRIL 21 THE AUTO WAS THE 838 00:44:45,880 --> 00:44:52,000 FIRST ONE RECEIVING THE EUA -- 839 00:44:52,000 --> 00:44:56,720 IN JULY 21 AGAIN AUTO DIAGNOSTIC 840 00:44:56,720 --> 00:44:59,840 WAS THE FIRST RECEIVING FOR THE 841 00:44:59,840 --> 00:45:02,920 QUANTITATIVE ASSAY. 842 00:45:02,920 --> 00:45:05,320 SO THE U.S. IS THE ONLY ONE. 843 00:45:05,320 --> 00:45:08,120 DIFFERENT STORY FROM EUROPE 844 00:45:08,120 --> 00:45:09,560 WHERE MOST OF THE TESTS ARE 845 00:45:09,560 --> 00:45:12,880 REFERRING TO THE STANDARD. 846 00:45:12,880 --> 00:45:15,400 IN AUGUST WE WERE ASKED TO LABEL 847 00:45:15,400 --> 00:45:18,960 OUR UNITS AS HIGH TIGHTER AND 848 00:45:18,960 --> 00:45:21,320 THE UNIT THAT WAS CALLED HIGH 849 00:45:21,320 --> 00:45:23,720 TIGHTER IS THE SIGNAL TO CUT OFF 850 00:45:23,720 --> 00:45:25,320 RATIO. 851 00:45:25,320 --> 00:45:26,800 IN FEBRUARY THAT NUMBER WAS 852 00:45:26,800 --> 00:45:29,200 CHANGED AGAIN AND WAS REQUIRED 853 00:45:29,200 --> 00:45:30,920 TO BE 9.5. 854 00:45:30,920 --> 00:45:33,120 AND NOW IN DECEMBER THE HIGH 855 00:45:33,120 --> 00:45:35,240 TIGHTER IS WHEN WE HAVE A 856 00:45:35,240 --> 00:45:37,240 QUANTIFICATION AND THE 857 00:45:37,240 --> 00:45:39,560 QUANTIFICATION IS -- 858 00:45:39,560 --> 00:45:40,680 [ INDISCERNIBLE ] 859 00:45:40,680 --> 00:45:47,680 GREATER OR EQUAL TO 200. 860 00:45:47,680 --> 00:45:50,960 BY THE TIME AND DR. WEST WAS 861 00:45:50,960 --> 00:45:52,720 EXPLAINING TO YOU THIS WAS 862 00:45:52,720 --> 00:45:53,920 REALLY CHALLENGING. 863 00:45:53,920 --> 00:46:00,520 BY THE TIME FDA WAS CHANGING WAS 864 00:46:00,520 --> 00:46:03,040 ASKING US TO LABEL OF COURSE WE 865 00:46:03,040 --> 00:46:05,560 HAD MOST OF OUR UNITS ALREADY 866 00:46:05,560 --> 00:46:09,000 LABELED. 867 00:46:09,000 --> 00:46:10,480 [ INDISCERNIBLE ] 868 00:46:10,480 --> 00:46:13,520 WE HAD TO GO BACK AND LOOK 869 00:46:13,520 --> 00:46:16,520 ACROSS THE 500 UNITS THAT HAD 870 00:46:16,520 --> 00:46:17,720 BEEN COLLECTED AT THAT POINT. 871 00:46:17,720 --> 00:46:20,000 HOW MANY OF THOSE THAT THE 872 00:46:20,000 --> 00:46:21,800 SIGNIFICANT VALUE OF 12 THAT 873 00:46:21,800 --> 00:46:23,760 COULD BE CLASSIFIED AS HIGH 874 00:46:23,760 --> 00:46:25,640 TIGHTER. 875 00:46:25,640 --> 00:46:30,640 WE WERE LUCKY BECAUSE 185 OR 37% 876 00:46:30,640 --> 00:46:33,320 OF THE UNIT -- IT WAS GREATER 877 00:46:33,320 --> 00:46:35,760 THAN 12 SO IT COULD BE LABELED 878 00:46:35,760 --> 00:46:46,120 AS HIGH TIGHTER. 879 00:46:46,120 --> 00:46:49,200 AND THAT NUMBER THE NEUTRALIZING 880 00:46:49,200 --> 00:46:51,880 NUMBER IS WHAT IS THE THE 881 00:46:51,880 --> 00:46:53,760 BEGINNING AGAIN WHEN THERE WAS 882 00:46:53,760 --> 00:46:55,920 NO SEROLOGICAL TEST AVAILABLE 883 00:46:55,920 --> 00:46:57,680 WAS INDICATED AS A GOOD NUMBER 884 00:46:57,680 --> 00:46:59,720 AS A GOOD TIGHTER ACCEPTABLE 885 00:46:59,720 --> 00:47:01,440 TIGHTER. 886 00:47:01,440 --> 00:47:07,360 SO MOST OF THE UNIT -- REQUIRED 887 00:47:07,360 --> 00:47:08,000 BY FDA -- 888 00:47:08,000 --> 00:47:08,720 [ INDISCERNIBLE ] 889 00:47:08,720 --> 00:47:10,800 THAT WAS PRETTY MUCH MATCHING. 890 00:47:10,800 --> 00:47:13,680 SO THE TWO ASSAY WERE 891 00:47:13,680 --> 00:47:14,920 CORRELATING PRETTY WELL. 892 00:47:14,920 --> 00:47:17,640 AND THEN OF COURSE WE CHANGED TO 893 00:47:17,640 --> 00:47:21,120 9.5 SO WE HAD TO GO BACK AND DO 894 00:47:21,120 --> 00:47:23,400 THE SAME THING. 895 00:47:23,400 --> 00:47:27,120 THIS TIME 242 OF THE UNIT SO WE 896 00:47:27,120 --> 00:47:29,720 HAD AN INCREASED NUMBER -- 48% 897 00:47:29,720 --> 00:47:37,480 OF THE UNIT -- AND 66% OF THOSE 898 00:47:37,480 --> 00:47:41,680 ALSO HAD GOOD NEUTRALIZING 899 00:47:41,680 --> 00:47:42,120 TIGHTERS. 900 00:47:42,120 --> 00:47:43,760 THEY WERE FUNCTIONING PRETTY 901 00:47:43,760 --> 00:47:45,280 WELL. 902 00:47:45,280 --> 00:47:46,920 IT WAS VERY GOOD SURPRISE. 903 00:47:46,920 --> 00:47:49,320 BUT THEN WE HAD TO MOVE ON THE 904 00:47:49,320 --> 00:47:50,720 QUANTIFICATION ASSAY. 905 00:47:50,720 --> 00:47:53,880 SO WE HAVE REALLY FEW UNIT THAT 906 00:47:53,880 --> 00:47:57,520 ARE NOT EXPIRED YET IN OUR 907 00:47:57,520 --> 00:47:58,080 REPOSITORY. 908 00:47:58,080 --> 00:48:00,600 AND WE WENT BACK TO QUANTIFY 909 00:48:00,600 --> 00:48:02,640 SOME OF THESE UNITS AND 910 00:48:02,640 --> 00:48:06,280 INTERESTING ALL OF THE UNITS 911 00:48:06,280 --> 00:48:10,840 THAT THEY HAD -- A VALUE OF LESS 912 00:48:10,840 --> 00:48:12,720 THAN 9.5 THEY DID NOT QUALIFY AS 913 00:48:12,720 --> 00:48:14,240 YOU CAN SEE FROM THIS PLOT. 914 00:48:14,240 --> 00:48:16,560 BUT THE ONE THAT WERE GREATER OR 915 00:48:16,560 --> 00:48:20,120 EQUAL TO 9.5 THEY COULD QUANTIFY 916 00:48:20,120 --> 00:48:25,520 SO ALMOST ALL OF THEM -- HAD A 917 00:48:25,520 --> 00:48:29,200 VALUE OF BAU OF 200. 918 00:48:29,200 --> 00:48:36,960 WE WERE CURIOUS TO SEE -- -- 919 00:48:36,960 --> 00:48:38,720 CORRELATING THESE RESULTS. 920 00:48:38,720 --> 00:48:44,800 THE RED DOTS -- THEY ARE THE BAU 921 00:48:44,800 --> 00:48:47,120 THAT IS EQUAL OR GREATER THAN 922 00:48:47,120 --> 00:48:48,920 200. 923 00:48:48,920 --> 00:48:51,680 AND ALSO THE NEUTRALIZING 924 00:48:51,680 --> 00:48:53,440 TIGHTER FOR ALMOST ALL OF THEM 925 00:48:53,440 --> 00:48:57,320 IS PRETTY HIGH SO WE'RE ABOVE 926 00:48:57,320 --> 00:48:58,840 180 SO GOOD CORRELATION WITHIN 927 00:48:58,840 --> 00:49:00,520 THE TESTING. 928 00:49:00,520 --> 00:49:02,560 WE HAVE BEEN USING. 929 00:49:02,560 --> 00:49:04,480 WE ARE NOW FACING A NEW PROBLEM 930 00:49:04,480 --> 00:49:05,320 WITH THE QUANTIFICATION. 931 00:49:05,320 --> 00:49:21,440 7 SO AGAIN IGG-QUANT -- TO USE 932 00:49:21,440 --> 00:49:24,080 THE TEST WITHOUT ANY DILUTION SO 933 00:49:24,080 --> 00:49:27,000 WE CANNOT MAKE DILUTION. 934 00:49:27,000 --> 00:49:30,520 WHEN WE WERE LOOKING AT THE DATA 935 00:49:30,520 --> 00:49:33,840 IN UNVACCINATED CONVALESCENT 936 00:49:33,840 --> 00:49:37,080 PLASMA DONORS WE WERE REALIZING 937 00:49:37,080 --> 00:49:40,520 THAT LOOKING AT NEUTRALIZING 938 00:49:40,520 --> 00:49:42,720 ANTIBODIES THE TWO DIFFERENT 939 00:49:42,720 --> 00:49:45,360 SAMPLES -- THEY ARE DIFFERENT 940 00:49:45,360 --> 00:49:47,720 NEUTRALIZING ANTIBODIES. 941 00:49:47,720 --> 00:49:49,720 PARTICULARLY VACCINATED DONORS 942 00:49:49,720 --> 00:49:53,080 THEY HAD SKY HIGH NIGHT LIGHTING 943 00:49:53,080 --> 00:49:58,640 TIGHTER. 944 00:49:58,640 --> 00:50:05,200 NEUTRALIZING TIGHTER. 945 00:50:05,200 --> 00:50:08,120 *. 946 00:50:08,120 --> 00:50:11,520 THE READING IS FOR ABOVE 200. 947 00:50:11,520 --> 00:50:15,920 YOU CAN SEE HOW THE VACCINATED 948 00:50:15,920 --> 00:50:18,240 IGG QUANTIFICATION IS MUCH 949 00:50:18,240 --> 00:50:20,320 HIGHER AND THAT IS CONFIRMED BY 950 00:50:20,320 --> 00:50:22,320 NEUTRALIZING TIGHTER BUT ALSO 951 00:50:22,320 --> 00:50:23,640 ANTIBODY TESTS. 952 00:50:23,640 --> 00:50:26,720 THE IGG IS NOW CONFIRMING THAT 953 00:50:26,720 --> 00:50:28,480 BECAUSE I BELIEVE THERE IS A 954 00:50:28,480 --> 00:50:31,000 KIND OF LIMIT IN THE TEST. 955 00:50:31,000 --> 00:50:34,120 THERE ARE TOO MUCH IGG IN THE 956 00:50:34,120 --> 00:50:36,120 SAMPLES AND IT'S LIKE THERE IS A 957 00:50:36,120 --> 00:50:38,720 KIND OF SATURATION EFFECT SO THE 958 00:50:38,720 --> 00:50:41,600 PROCESS CANNOT DETECT WHAT IS 959 00:50:41,600 --> 00:50:42,720 THERE IN REALITY. 960 00:50:42,720 --> 00:50:45,160 WE ALSO EXTENDED THIS 961 00:50:45,160 --> 00:50:48,200 OBSERVATION ON MORE SAMPLES. 962 00:50:48,200 --> 00:50:51,400 AND AS YOU CAN SEE THE ONE WITH 963 00:50:51,400 --> 00:50:55,080 THE HIGH NEUTRALIZING PATTERNS 964 00:50:55,080 --> 00:51:00,440 WERE THE ONES -- DILUTION. 965 00:51:00,440 --> 00:51:03,160 SO THIS IS SOMETHING THAT IS 966 00:51:03,160 --> 00:51:08,600 BEING DISCUSSED AND WITH THE ABB 967 00:51:08,600 --> 00:51:10,520 THERE ARE MANY GROUPS WORKING ON 968 00:51:10,520 --> 00:51:13,360 THIS AND WE TRY TO GATHER AS 969 00:51:13,360 --> 00:51:15,000 MUCH DATA AS POSSIBLE BECAUSE 970 00:51:15,000 --> 00:51:20,760 THERE IS NEED FOR CHANGE IN THIS 971 00:51:20,760 --> 00:51:26,920 ASSAY. 972 00:51:26,920 --> 00:51:30,040 WE CONDUCTED THE LONGITUDINAL 973 00:51:30,040 --> 00:51:32,840 SATISFACTORY LOGICAL ASSESSMENT 974 00:51:32,840 --> 00:51:37,640 OF 228 CONVALESCENT PLASMA 975 00:51:37,640 --> 00:51:38,720 DONORS AFTER RECOVERY. 976 00:51:38,720 --> 00:51:43,720 THETHEY WERE ASSESSED FOR THE 977 00:51:43,720 --> 00:51:45,960 LEVEL. 978 00:51:45,960 --> 00:51:49,080 AT THE FIRST STUDY WE SEE THE 979 00:51:49,080 --> 00:51:53,520 DONORS PRESENTED THE MEDIAN OF 980 00:51:53,520 --> 00:51:55,440 47 DAYS FOR SYMPTOM RESOLUTION 981 00:51:55,440 --> 00:51:58,440 AND WE OBSERVED THE HIGH RATE OF 982 00:51:58,440 --> 00:52:01,360 CONVERSES FOR TOTAL. 983 00:52:01,360 --> 00:52:07,640 AS YOU CAN SEE IN THE PLOT 97% 984 00:52:07,640 --> 00:52:10,600 PRESENTED ANTIBODIES. 985 00:52:10,600 --> 00:52:17,520 AND 72% NEUTRALIZING. 986 00:52:17,520 --> 00:52:24,920 THE MAJORITY OF THE DONORS HAD 987 00:52:24,920 --> 00:52:25,920 MODEST ACTIVITY. 988 00:52:25,920 --> 00:52:27,680 BUT WE COULD MEASURE THAT AND 989 00:52:27,680 --> 00:52:28,840 THAT WAS GOOD. 990 00:52:28,840 --> 00:52:33,160 THE DONOR THEY COME BACK FOR -- 991 00:52:33,160 --> 00:52:35,920 A REPEAT STUDY VISIT. 992 00:52:35,920 --> 00:52:38,120 SO THEY AS DR. WEST WAS SAYING 993 00:52:38,120 --> 00:52:39,640 WE'VE AMAZING DONORS. 994 00:52:39,640 --> 00:52:42,400 THEY ARE WILLING TO COME BACK. 995 00:52:42,400 --> 00:52:44,120 AND THEY WERE COMING BACK. 996 00:52:44,120 --> 00:52:47,120 WE HAVE SOME OF THEM LIKE NINE 997 00:52:47,120 --> 00:52:48,360 TIME POINTS THEY WERE COMING 998 00:52:48,360 --> 00:52:50,760 BACK AND LET US LOOK AT THEIR 999 00:52:50,760 --> 00:52:53,080 ANTIBODIES. 1000 00:52:53,080 --> 00:52:56,320 WE FOLLOWED THEM FOR UP TO 1001 00:52:56,320 --> 00:53:02,160 ELEVEN MONTHS. 1002 00:53:02,160 --> 00:53:06,520 THE FIRST WAS AT 42 DAYS. 1003 00:53:06,520 --> 00:53:13,120 THE FINAL WAS 196 DAYS BUT WE -- WE 1004 00:53:13,120 --> 00:53:14,680 WENT UP TO ELEVEN MONTHS. 1005 00:53:14,680 --> 00:53:16,840 THIS IS A PUBLISHED PAPER AND 1006 00:53:16,840 --> 00:53:21,040 YOU CAN HAVE ACCESS TO THIS. 1007 00:53:21,040 --> 00:53:24,560 71%, THEY HAD A DECREASED VALUE 1008 00:53:24,560 --> 00:53:30,320 BUT WE WERE STILL ABLE TO DETECT 1009 00:53:30,320 --> 00:53:32,680 AGG AND 4% HAD NO CHANGE. 1010 00:53:32,680 --> 00:53:35,880 IG WAS PRETTY STABLE. 1011 00:53:35,880 --> 00:53:38,320 FOR UP TO ELEVEN MONTHS. 1012 00:53:38,320 --> 00:53:40,760 WHEN WE WERE LOOKING AT 1013 00:53:40,760 --> 00:53:45,320 NEUTRALIZING TIGHTER IF WE 1014 00:53:45,320 --> 00:53:48,840 LOOKED AT IT WE WERE OBSERVING 1015 00:53:48,840 --> 00:53:52,840 THAT 37% OF THE DONORS HAD NO 1016 00:53:52,840 --> 00:53:54,920 TIGHTER. 1017 00:53:54,920 --> 00:53:56,280 THEY LOST -- 1018 00:53:56,280 --> 00:53:58,120 [ INDISCERNIBLE ] 1019 00:53:58,120 --> 00:54:04,280 BUT WHEN WE STRATIFIED -- THE 1020 00:54:04,280 --> 00:54:05,840 SITUATION CHANGED. 1021 00:54:05,840 --> 00:54:07,920 AND IN THE HIGH STARTING TIGHTER 1022 00:54:07,920 --> 00:54:13,400 DONOR WE HAVE HIGH NUMBER OF 1023 00:54:13,400 --> 00:54:16,200 DONORS THAT STILL HAVE 1024 00:54:16,200 --> 00:54:17,440 ANTIBODIES PRESENT OVER ELEVEN 1025 00:54:17,440 --> 00:54:19,320 MONTHS. 1026 00:54:19,320 --> 00:54:22,920 SO -- NEUTRALIZING ANTIBODIES -- 1027 00:54:22,920 --> 00:54:25,520 LOOKS LIKE THEY PERSIST IN 1028 00:54:25,520 --> 00:54:27,360 HEALTHY PEOPLE OVER ALMOST THE 1029 00:54:27,360 --> 00:54:29,000 FIRST YEAR. 1030 00:54:29,000 --> 00:54:32,000 WE ARE KEEP FOLLOWING SOME OF 1031 00:54:32,000 --> 00:54:34,320 THE DONORS. 1032 00:54:34,320 --> 00:54:38,880 WE HAVE 116 OF THE 228. 1033 00:54:38,880 --> 00:54:41,360 THEY DIDN'T GET VACCINATED. 1034 00:54:41,360 --> 00:54:44,480 IF YOU SEE ON THIS PLOT WE HAVE 1035 00:54:44,480 --> 00:54:48,360 DATA POINT THAT GOES OVER 600 1036 00:54:48,360 --> 00:54:50,640 DAYS FOR SYMPTOM RESOLUTION. 1037 00:54:50,640 --> 00:54:55,560 THE RED ARROW IS INDICATING WHEN 1038 00:54:55,560 --> 00:54:58,160 YOU ARE OBSERVE AN IGG LEVEL OFF 1039 00:54:58,160 --> 00:55:04,280 THAT IS ALMOST AT ONE YEAR FROM 1040 00:55:04,280 --> 00:55:07,640 THE LAST DAY OF SYMPTOM 1041 00:55:07,640 --> 00:55:07,920 RESOLUTION. 1042 00:55:07,920 --> 00:55:09,640 AND REALLY WE'RE FOLLOWING THEM. 1043 00:55:09,640 --> 00:55:12,720 THERE IS ONLY ONE THAT IS 1044 00:55:12,720 --> 00:55:14,000 INDICATED WITH THE SQUARE THAT 1045 00:55:14,000 --> 00:55:16,120 LOOKED LIKE THERE IS A SPIKE. 1046 00:55:16,120 --> 00:55:18,520 WE'RE HAVING IS THIS. 1047 00:55:18,520 --> 00:55:19,640 PROBABLY THIS PERSON GOT 1048 00:55:19,640 --> 00:55:23,400 INFECTED SO WE NEED TO MAKE SURE 1049 00:55:23,400 --> 00:55:27,520 THAT THAT AGAIN USING THE "N" 1050 00:55:27,520 --> 00:55:29,720 ANTIBODIES IF THERE WAS AN 1051 00:55:29,720 --> 00:55:31,120 INFECTION. 1052 00:55:31,120 --> 00:55:33,360 BUT STILL VERY ENCOURAGING. 1053 00:55:33,360 --> 00:55:37,000 WE ARE ALSO FOLLOWING OUR DONORS 1054 00:55:37,000 --> 00:55:39,320 THAT GOT VACCINATED. 1055 00:55:39,320 --> 00:55:44,080 I'M SHOWING ONLY J&J VACCINE AND 1056 00:55:44,080 --> 00:55:46,160 YOU CAN CLEARLY TELL WHEN THE 1057 00:55:46,160 --> 00:55:47,480 DONORS RECEIVED THE VACCINE. 1058 00:55:47,480 --> 00:55:48,920 THERE IS A CLEAR SPIKE. 1059 00:55:48,920 --> 00:55:52,960 IN IGG ON THE LEFT SIDE AND 1060 00:55:52,960 --> 00:55:55,640 NEUTRALIZING ON THE RIGHT SIDE. 1061 00:55:55,640 --> 00:56:03,640 WHAT WE'RE NOW DOING -- WE'RE 1062 00:56:03,640 --> 00:56:07,120 KEEP CHARACTERIZING THE 1063 00:56:07,120 --> 00:56:09,360 EVOLUTION OF ANTIBODY ACTIVITY. 1064 00:56:09,360 --> 00:56:11,480 I THINK THERE IS STILL A LOT WE 1065 00:56:11,480 --> 00:56:14,200 NEED TO LEARN IN TERMS OF ASSAY. 1066 00:56:14,200 --> 00:56:19,080 SO WE'RE TRYING TO UNDERSTAND 1067 00:56:19,080 --> 00:56:21,360 HOW THE TIGHTER THE TARGET THE 1068 00:56:21,360 --> 00:56:23,160 VARIANTS ARE IN SOME WAY 1069 00:56:23,160 --> 00:56:27,080 IMPACTINGS THE TESTING RESULTS. 1070 00:56:27,080 --> 00:56:29,520 WE ARE ALSO CORRELATING THE 1071 00:56:29,520 --> 00:56:32,720 VITRO -- QUANTITATIVE ASSAY. 1072 00:56:32,720 --> 00:56:34,560 WITH NEUTRALIZING ASSAY. 1073 00:56:34,560 --> 00:56:37,880 OUR SAMPLE CORE IS VACCINATED 1074 00:56:37,880 --> 00:56:39,560 CONVALESCENT PLASMA DONOR. 1075 00:56:39,560 --> 00:56:42,200 WE HAVE ALMOST 150 DONORS THAT 1076 00:56:42,200 --> 00:56:43,520 ARE WILLING TO COME BACK. 1077 00:56:43,520 --> 00:56:45,120 WE HAVE NONVACCINATED 1078 00:56:45,120 --> 00:56:46,200 CONVALESCENT DONORS. 1079 00:56:46,200 --> 00:56:50,640 WE HAVE 13 AND THEN WE HAVE -- 1080 00:56:50,640 --> 00:56:52,880 VACCINATED DONOR. 1081 00:56:52,880 --> 00:56:55,400 IN CONCLUSION AS DR. WEST WAS 1082 00:56:55,400 --> 00:56:57,720 POINTING OUT THIS WAS A BIG 1083 00:56:57,720 --> 00:56:59,920 LEARNING EXPERIENCE. 1084 00:56:59,920 --> 00:57:02,120 I DON'T KNOW WHEN IT'S GOING TO 1085 00:57:02,120 --> 00:57:03,720 HAPPEN AGAIN THAT WHILE YOU'RE 1086 00:57:03,720 --> 00:57:05,280 TESTING YOU'RE LEARNING THAT 1087 00:57:05,280 --> 00:57:06,880 THAT TEST IS NOT WORKING 1088 00:57:06,880 --> 00:57:07,280 PERFECTLY. 1089 00:57:07,280 --> 00:57:08,840 YOU HAVE TO MAKE ADJUSTMENT. 1090 00:57:08,840 --> 00:57:10,720 YOU HAVE TO GO BACK AND RETEST 1091 00:57:10,720 --> 00:57:13,400 AGAIN. 1092 00:57:13,400 --> 00:57:15,880 WORKING WITH SO MANY SCIENTISTS 1093 00:57:15,880 --> 00:57:18,480 AROUND THE WORLD EXCHANGING 1094 00:57:18,480 --> 00:57:20,320 DATA. 1095 00:57:20,320 --> 00:57:22,320 EXCHANGING THOUGHTS AND ALL 1096 00:57:22,320 --> 00:57:24,120 WORKING FOR THE SAME CAUSE. 1097 00:57:24,120 --> 00:57:26,480 THAT WAS SOMETHING ABSOLUTELY I 1098 00:57:26,480 --> 00:57:28,560 WOULD SAY AMAZING. 1099 00:57:28,560 --> 00:57:32,240 ALSO THAT WAS A BIG CHALLENGE ON 1100 00:57:32,240 --> 00:57:34,840 THE REGULATORY STANDPOINT. 1101 00:57:34,840 --> 00:57:38,720 BECAUSE WE HAD TO CHANGE THREE 1102 00:57:38,720 --> 00:57:41,240 TIMES OUR QUALIFICATION CRITERIA 1103 00:57:41,240 --> 00:57:43,360 FOR THE CONVALESCENT PLASMA UNIT 1104 00:57:43,360 --> 00:57:46,040 AND THAT WAS A BIG CHALLENGE. 1105 00:57:46,040 --> 00:57:49,680 NOT ONLY -- IN PROVIDING THE 1106 00:57:49,680 --> 00:57:52,120 DATA BUT ON THE REGULATORY SIDE 1107 00:57:52,120 --> 00:57:54,520 THAT WAS PAINFUL AND OF COURSE 1108 00:57:54,520 --> 00:57:58,320 ALL THE GROUP THAT DR. WEST WAS 1109 00:57:58,320 --> 00:57:59,440 MENTIONING WE WERE REALLY 1110 00:57:59,440 --> 00:58:01,200 WORKING AS ONE TEAM. 1111 00:58:01,200 --> 00:58:03,320 IT WAS A LOT OF WORK. 1112 00:58:03,320 --> 00:58:08,000 ALSO WANT TO POINT OUT THAT CCP 1113 00:58:08,000 --> 00:58:10,840 DONOR THEY ARE A HIGHLY VALUABLE 1114 00:58:10,840 --> 00:58:13,840 COURT BECAUSE THEY MAY RETURN 1115 00:58:13,840 --> 00:58:15,200 FOR REPEAT DONATIONS. 1116 00:58:15,200 --> 00:58:16,960 SO THEY ARE PROVIDING AN 1117 00:58:16,960 --> 00:58:21,280 OPPORTUNITY TO CHARACTERIZE 1118 00:58:21,280 --> 00:58:23,440 SARS-CoV-2 SEROLOGICAL 1119 00:58:23,440 --> 00:58:29,480 RESPONSE. 1120 00:58:29,480 --> 00:58:32,360 SO WE HAVE CLINICAL INFORMATION. 1121 00:58:32,360 --> 00:58:34,480 WE HAVE THIS FANTASTIC DONORS 1122 00:58:34,480 --> 00:58:36,240 THAT THEY COME MONTHLY. 1123 00:58:36,240 --> 00:58:39,240 SO I THINK THIS IS AN IMPORTANT 1124 00:58:39,240 --> 00:58:39,720 TOOLS. 1125 00:58:39,720 --> 00:58:43,320 THAT WE NEED TO KEEP FOLLOWING. 1126 00:58:43,320 --> 00:58:46,880 AND STUDYING AND WITH THIS I 1127 00:58:46,880 --> 00:58:48,360 WANT TO THANK MY FANTASTIC 1128 00:58:48,360 --> 00:58:49,280 GROUP. 1129 00:58:49,280 --> 00:58:53,120 THE INFECTIOUS DISEASE SECTION. 1130 00:58:53,120 --> 00:58:55,840 THEY WERE ESSENTIAL FOR ALL OF 1131 00:58:55,840 --> 00:58:57,840 THE DATA I'VE SHOWN YOU TODAY. 1132 00:58:57,840 --> 00:59:02,840 I WANT TO THANK DR. WEST'S 1133 00:59:02,840 --> 00:59:06,560 GROUP, -- THEY ARE ABSOLUTELY A 1134 00:59:06,560 --> 00:59:06,960 TREASURE. 1135 00:59:12,320 --> 00:59:15,640 NIAID GROUP. 1136 00:59:15,640 --> 00:59:20,720 AND OF COURSE OUR DEPARTMENT 1137 00:59:20,720 --> 00:59:26,520 CHIEF. 1138 00:59:26,520 --> 00:59:28,920 FOR HELPING US TO NAVIGATE 1139 00:59:28,920 --> 00:59:31,040 THROUGH ALL OF THESE REGULATORY 1140 00:59:31,040 --> 00:59:31,800 CHANGE. 1141 00:59:31,800 --> 00:59:34,880 WITH THIS I'LL STOP SHARING. 1142 00:59:34,880 --> 00:59:36,120 I HOPE WE HAVE TIME FOR 1143 00:59:36,120 --> 00:59:39,720 QUESTIONS. 1144 00:59:39,720 --> 00:59:41,680 >> DR. WEST AND DR. DE GIORGI. 1145 00:59:41,680 --> 00:59:44,000 WE'RE AT THE HOUR SO WE WILL NOT 1146 00:59:44,000 --> 00:59:47,120 BE ABLE TO ENTERTAIN ANY 1147 00:59:47,120 --> 00:59:47,360 QUESTIONS. 1148 00:59:47,360 --> 00:59:53,520 BUT SEEING YOUR OWN WORK IN 1149 00:59:53,520 --> 00:59:56,800 PROGRESS -- IN THIS RAPIDLY 1150 00:59:56,800 --> 00:59:58,120 EVOLVING FIELD IS BOTH 1151 00:59:58,120 --> 00:59:59,680 APPRECIATED AND APPLAUDED AND WE 1152 00:59:59,680 --> 01:00:02,240 WANT TO THANK YOU VERY MUCH FOR 1153 01:00:02,240 --> 01:00:03,480 PRESENTING YOUR VERY IMPORTANT 1154 01:00:03,480 --> 01:00:05,120 WORK TO THE COMMUNITY. 1155 01:00:05,120 --> 01:00:06,000 THANK YOU EVERYONE AND WISH 1156 01:00:06,000 --> 01:00:07,960 EVERYONE A GOOD AFTERNOON. 1157 01:00:07,960 --> 01:01:17,880 THANK YOU.