1 00:00:06,144 --> 00:00:07,279 >> GOOD AFTERNOON. 2 00:00:07,279 --> 00:00:10,649 MY NAME IS DR. SHANNA CLARK, THE 3 00:00:10,649 --> 00:00:12,551 ASSOCIATE DIRECTOR OF THE CANCER 4 00:00:12,551 --> 00:00:14,586 FOR CENTER RESEARCH'S OFFICE OF 5 00:00:14,586 --> 00:00:16,088 EQUITY AND INCLUSION AND THE 6 00:00:16,088 --> 00:00:18,590 SENIOR DIVERSITY ADVISOR TO THE 7 00:00:18,590 --> 00:00:18,857 DIRECTOR. 8 00:00:18,857 --> 00:00:20,692 I'M EXCITED TODAY TO INTRODUCE 9 00:00:20,692 --> 00:00:23,829 YOU TO OUR GRAND ROUNDS SPEAKER 10 00:00:23,829 --> 00:00:27,733 WHO I MET AT ASH ABOUT A YEAR 11 00:00:27,733 --> 00:00:31,803 AGO AND WAS SO BLOWN AWAY BY HER 12 00:00:31,803 --> 00:00:42,314 I KNEW WE HAD TO GET HER HERE. 13 00:00:45,284 --> 00:00:47,486 DIRECTOR OF COMMUNITY 14 00:00:47,486 --> 00:00:48,086 ENGAGEMENT, ASSOCIATE DIRECTOR 15 00:00:48,086 --> 00:00:49,788 OF CELL AND GENE THERAPY IN THE 16 00:00:49,788 --> 00:00:51,690 CLINICAL RESEARCH OFFICE AND THE 17 00:00:51,690 --> 00:00:52,357 CHIEF DIVERSITY OFFICER OF THE 18 00:00:52,357 --> 00:00:55,794 CENTER FOR CELL AND GENE THERAPY 19 00:00:55,794 --> 00:00:56,395 AT BAYLOR COLLEGE OF MEDICINE. 20 00:00:56,395 --> 00:00:58,330 THAT'S A LOT OF HATS. 21 00:00:58,330 --> 00:01:01,199 HER RESEARCH AND CLINICAL 22 00:01:01,199 --> 00:01:03,302 INTERESTS FOCUS ON REFRACTARY 23 00:01:03,302 --> 00:01:04,670 MALIGNANCIES SPECIFICALLY HOW TO 24 00:01:04,670 --> 00:01:06,805 HARNESS THE TRANSLATIONAL AND 25 00:01:06,805 --> 00:01:07,973 CLINICAL RESEARCH PROGRAM 26 00:01:07,973 --> 00:01:10,175 CREATING NOVEL EARLY-PHASE CELL 27 00:01:10,175 --> 00:01:12,144 AND GENE THERAPY PRODUCTS AND 28 00:01:12,144 --> 00:01:14,046 TRANSLATING THEM TO 29 00:01:14,046 --> 00:01:15,047 FIRST-IN-HUMAN IMMUNOTHERAPY 30 00:01:15,047 --> 00:01:15,280 TRIALS. 31 00:01:15,280 --> 00:01:16,848 SHE ALSO SERVES AS PROJECT 32 00:01:16,848 --> 00:01:19,718 LEADER FOR PROJECTS ON THE NIH 33 00:01:19,718 --> 00:01:21,653 LYMPHOMA SPORE, LEUKEMIA AND 34 00:01:21,653 --> 00:01:22,955 LYMPHOMA SOCIETY SPECIALIZED 35 00:01:22,955 --> 00:01:24,756 CENTER OF RESEARCH PROGRESS AND 36 00:01:24,756 --> 00:01:26,992 STAND UP TO CANCER, FOR WHICH 37 00:01:26,992 --> 00:01:29,328 SHE RECEIVED A NCI INVESTIGATOR 38 00:01:29,328 --> 00:01:31,430 TEAM LEADERSHIP AWARD. 39 00:01:31,430 --> 00:01:34,199 SHE IS THE DIRECTOR OF THE C I 40 00:01:34,199 --> 00:01:35,000 GT, CLINICAL RESEARCH OPERATIONS 41 00:01:35,000 --> 00:01:36,835 AND THE IMMUNOTHERAPY 42 00:01:36,835 --> 00:01:37,135 FELLOWSHIP. 43 00:01:37,135 --> 00:01:38,804 SHE IS PASSIONATE ABOUT 44 00:01:38,804 --> 00:01:40,339 ENHANCING THE NUMBER AND 45 00:01:40,339 --> 00:01:42,107 DIVERSITY OF YOUNG INVESTIGATORS 46 00:01:42,107 --> 00:01:44,009 IN CANCER RESEARCH AND HAS A 47 00:01:44,009 --> 00:01:45,510 STRONG INTEREST IN HEALTH 48 00:01:45,510 --> 00:01:46,478 DISPARITIES RESEARCH. 49 00:01:46,478 --> 00:01:47,713 AS SUCH, SHE LEADS THE TASK 50 00:01:47,713 --> 00:01:50,048 FORCE FOR PROMOTING DIVERSITY IN 51 00:01:50,048 --> 00:01:52,517 CLINICAL TRIALS WITHIN THE DAN L 52 00:01:52,517 --> 00:01:53,885 DUNK AN COMPREHENSIVE CANCER 53 00:01:53,885 --> 00:01:54,119 CENTER. 54 00:01:54,119 --> 00:01:56,221 SHE LEADS THE DEIA INITIATIVES 55 00:01:56,221 --> 00:02:01,493 AT ASH, ASGST AND ASTCT AND 56 00:02:01,493 --> 00:02:03,462 PRESENTED ON CAR T ACCESS TO 57 00:02:03,462 --> 00:02:05,230 CONGRESS, COMBINING HER 58 00:02:05,230 --> 00:02:08,066 COMPASSIONS FOR BOTH SCIENCE AND 59 00:02:08,066 --> 00:02:08,667 ADVOCACY. 60 00:02:08,667 --> 00:02:09,368 DR.EROUS RECEIVED NUMEROUS 61 00:02:09,368 --> 00:02:10,936 AWARDS INCLUDING THE BAYLOR 62 00:02:10,936 --> 00:02:11,803 COLLEGE OF MEDICINE'S DEPARTMENT 63 00:02:11,803 --> 00:02:14,673 OF PEDIATRICS YOUNG INVESTIGATOR 64 00:02:14,673 --> 00:02:16,008 AWARD, THE OUTSTANDING WOMEN IN 65 00:02:16,008 --> 00:02:18,110 SCIENCE AWARD FROM THE 66 00:02:18,110 --> 00:02:18,644 ASSOCIATION FOR WOMEN IN 67 00:02:18,644 --> 00:02:19,778 SCIENCE, THE BAYLOR COLLEGE OF 68 00:02:19,778 --> 00:02:23,548 MEDICINE MENTORSHIP AWARD AND 69 00:02:23,548 --> 00:02:24,616 THE HOUSTON CHRONICAL HURRICANE 70 00:02:24,616 --> 00:02:27,052 HARVEY HOMETOWN HERO AWARD, TO 71 00:02:27,052 --> 00:02:28,020 NAME A FEW. 72 00:02:28,020 --> 00:02:29,921 WITH THAT, I WILL INTRODUCE 73 00:02:29,921 --> 00:02:34,960 DR. RAYNE ROUCE. 74 00:02:34,960 --> 00:02:35,794 [ APPLAUSE ] 75 00:02:35,794 --> 00:02:37,729 >> THANK YOU FOR NA WONDERFUL 76 00:02:37,729 --> 00:02:38,063 INTRODUCTION. 77 00:02:38,063 --> 00:02:40,132 I'M SO EXCITED TO BE HERE. 78 00:02:40,132 --> 00:02:41,967 I GOT THE PLEASURE OF MEETING A 79 00:02:41,967 --> 00:02:44,636 NUMBER OF THE FELLOWS OVER 80 00:02:44,636 --> 00:02:45,937 LUNCH, WHICH IS ALWAYS AN 81 00:02:45,937 --> 00:02:48,840 AMAZING THING TO DO TO SEE THE 82 00:02:48,840 --> 00:02:50,942 FUTURE OF OUR FIELDS OF THE SO I 83 00:02:50,942 --> 00:02:52,144 CHANGED MY TITLE SLIGHTLY. 84 00:02:52,144 --> 00:02:53,311 I'M GOING TALK ABOUT, IF WE 85 00:02:53,311 --> 00:02:55,681 BUILD IT, THEY WILL COME. 86 00:02:55,681 --> 00:02:57,149 EXCEPT IF THEY CAN'T. 87 00:02:57,149 --> 00:03:00,318 STRATEGIES TO ENHANCE ACCESS TO 88 00:03:00,318 --> 00:03:01,920 GENE-MODIFIED CELL THERAPIES. 89 00:03:01,920 --> 00:03:03,855 HERE ARE MY DISCLOSURES. 90 00:03:03,855 --> 00:03:06,458 ALL OF THESE RELATIONSHIPS HAVE 91 00:03:06,458 --> 00:03:07,025 ENDED. 92 00:03:07,025 --> 00:03:11,029 SO, I'M GOING TO START BY 93 00:03:11,029 --> 00:03:16,068 SUMMARIZING RECENT ADVANCES. 94 00:03:16,068 --> 00:03:17,169 THEY DESCRIBE SOME OF THE UNIQUE 95 00:03:17,169 --> 00:03:18,637 CHALLENGES OF NOVEL CANCER CELL 96 00:03:18,637 --> 00:03:20,972 AND GENE THERAPIES THAT MAKE 97 00:03:20,972 --> 00:03:22,441 PARTICIPATION OF BOTH 98 00:03:22,441 --> 00:03:24,543 UNDERREPRESENTED AND UNDER 99 00:03:24,543 --> 00:03:25,510 RESOURCED PATIENTS CHALLENGING 100 00:03:25,510 --> 00:03:27,713 AND THEN ASSESS STRATEGIES TO 101 00:03:27,713 --> 00:03:29,147 INTENTIONALLY INCREASE ACCESS TO 102 00:03:29,147 --> 00:03:31,683 EARLY PHASE CANCER CELL AND GENE 103 00:03:31,683 --> 00:03:33,151 THERAPY CLINICAL TRIALS THAT ARE 104 00:03:33,151 --> 00:03:34,720 APPLICABLE TO ANY SORT OF CANCER 105 00:03:34,720 --> 00:03:35,220 CLINICAL TRIAL. 106 00:03:35,220 --> 00:03:39,958 IN 2024, THE JOURNEY TO A CANCER 107 00:03:39,958 --> 00:03:41,993 CURE AND THE ROAD BLOCKS ARE NEW 108 00:03:41,993 --> 00:03:42,494 AND UNIQUE. 109 00:03:42,494 --> 00:03:44,763 WE ARE USING MUTATION TARGETED 110 00:03:44,763 --> 00:03:44,996 THERAPY. 111 00:03:44,996 --> 00:03:47,365 WE HAVE THE ABILITY TO SEQUENCE 112 00:03:47,365 --> 00:03:47,799 PATIENT'S TUMORS. 113 00:03:47,799 --> 00:03:52,003 WE ARE USING MONOCLONAL 114 00:03:52,003 --> 00:03:54,372 ANTIBODIES OFTEN ALONE BUT IN 115 00:03:54,372 --> 00:03:55,273 COMBINATION WITH OTHER 116 00:03:55,273 --> 00:03:55,540 THERAPIES. 117 00:03:55,540 --> 00:03:57,242 WITH THE THIS QUEST FOR 118 00:03:57,242 --> 00:03:58,410 PERSONALIZED CANCER CARE, WE SEE 119 00:03:58,410 --> 00:04:03,148 NEW AND UNIQUE ROAD BLOCKS. 120 00:04:03,148 --> 00:04:05,050 MY RESEARCH IN CLINICAL ASPECT 121 00:04:05,050 --> 00:04:09,154 IS FOCUSED ON CART T-CELL 122 00:04:09,154 --> 00:04:09,387 THERAPY. 123 00:04:09,387 --> 00:04:10,856 AND SO I USED TO HAVE TO REALLY 124 00:04:10,856 --> 00:04:14,760 GO INTO A LOT OF DETAIL 125 00:04:14,760 --> 00:04:17,095 EXPLAINING WHAT A CAR-T CELL. 126 00:04:17,095 --> 00:04:20,665 WE ARE ABLE TO EN IN EAR T CELLS 127 00:04:20,665 --> 00:04:23,335 TO EXPRESS ARTIFICIAL RECEPTORS 128 00:04:23,335 --> 00:04:25,103 TO SPECIFICALLY TARGET AN 129 00:04:25,103 --> 00:04:26,571 ANTIGEN ON THE SURFACE OF A 130 00:04:26,571 --> 00:04:27,506 CANCER CELL. 131 00:04:27,506 --> 00:04:29,674 WE USUALLY USE A VIERS THAT 132 00:04:29,674 --> 00:04:31,343 CARRIES THAT NEW GENE INTO THE 133 00:04:31,343 --> 00:04:34,112 T-CELL AND CAUSES ALL OF THE T 134 00:04:34,112 --> 00:04:35,781 CELLS TO EXPRESS THIS ARTIFICIAL 135 00:04:35,781 --> 00:04:37,516 RECEPTOR WHICH CAN ULTIMATELY 136 00:04:37,516 --> 00:04:39,484 FIND ITS TARGET ALMOST LIKE A 137 00:04:39,484 --> 00:04:41,620 GPS TRACKING DEVICE, TARGET THAT 138 00:04:41,620 --> 00:04:44,156 CANCER CELL FOR KILL, BECOME 139 00:04:44,156 --> 00:04:46,525 ACTIVATED AND GO TO, IN MANY 140 00:04:46,525 --> 00:04:47,959 CASES, ERADICATE CANCERS. 141 00:04:47,959 --> 00:04:50,762 IN ORDER TO CREATE THESE CELL 142 00:04:50,762 --> 00:04:51,930 THERAPIES, WE TYPICALLY START 143 00:04:51,930 --> 00:04:53,398 WITH COLLECTING BLOOD FROM THE 144 00:04:53,398 --> 00:04:53,632 PATIENT. 145 00:04:53,632 --> 00:04:55,967 WE CAN DO THIS BY PERIPHERAL 146 00:04:55,967 --> 00:04:58,470 BLOOD, BUT WE CAN ALSO DO THIS 147 00:04:58,470 --> 00:05:01,807 THROUGH LEUKOPHORESIS ISOLATING 148 00:05:01,807 --> 00:05:02,741 OUT THE WHITE BLOOD CELLS AND 149 00:05:02,741 --> 00:05:04,743 THEN ISOLATING THE MONONUCLEAR 150 00:05:04,743 --> 00:05:04,976 CELLS. 151 00:05:04,976 --> 00:05:09,014 THEN FROM THAT, FEEDING WITH 152 00:05:09,014 --> 00:05:10,182 SPECIFIC STIMULANTS THAT T CELLS 153 00:05:10,182 --> 00:05:13,251 LOVE, AND THEN PROVIDING THIS 154 00:05:13,251 --> 00:05:14,119 TRANSDUCTION WHERE WE 155 00:05:14,119 --> 00:05:16,588 ESSENTIALLY PLACE THIS NEW GENE 156 00:05:16,588 --> 00:05:17,923 INTO THE T CELLS AND EXPANDING 157 00:05:17,923 --> 00:05:19,958 THESE CELLS OUT IN CULTURE TO 158 00:05:19,958 --> 00:05:21,693 MEET A CERTAIN DOSE TO GIVE TO 159 00:05:21,693 --> 00:05:23,695 PATIENTS AND WE START WITH THIS 160 00:05:23,695 --> 00:05:27,899 KIND OF REALLY POPULATION OF 161 00:05:27,899 --> 00:05:36,007 LOTS OF DIFFERENT WHITE BLOOD 162 00:05:36,007 --> 00:05:36,208 CELLS. 163 00:05:36,208 --> 00:05:38,276 THEN WE IN FUSE TO A PATIENT. 164 00:05:38,276 --> 00:05:40,212 SO THE STATE OF THE CELL THERAPY 165 00:05:40,212 --> 00:05:42,514 LANDSCAPE IN 2024 IS VERY 166 00:05:42,514 --> 00:05:43,815 DIFFERENT THAN IT WAS WHEN I 167 00:05:43,815 --> 00:05:46,117 STARTED IN THIS SPACE IN ABOUT 168 00:05:46,117 --> 00:05:47,219 2011, 2012. 169 00:05:47,219 --> 00:05:49,387 AND WE REALLY HAVE HAD SO MANY 170 00:05:49,387 --> 00:05:50,589 SCIENTIFIC ADVANCE SYSTEM. 171 00:05:50,589 --> 00:05:56,461 WE HAVE SIX FDA APPROVED CAR-T 172 00:05:56,461 --> 00:05:58,930 CELL AND NOW OVER THE DINNER 173 00:05:58,930 --> 00:06:01,833 TABLE, YOUR PARENT MIGHT KNOW, 174 00:06:01,833 --> 00:06:03,201 YOUR GRANDPARENT MIGHT KNOW WHAT 175 00:06:03,201 --> 00:06:04,703 A CAR-T CELL WAS. 176 00:06:04,703 --> 00:06:06,504 WE SEEN EXPANSION BEYOND BLOOD 177 00:06:06,504 --> 00:06:07,706 CANCERSES AND BEYOND T CELLS. 178 00:06:07,706 --> 00:06:09,541 WE ARE USING NATURAL KILLER 179 00:06:09,541 --> 00:06:14,746 CELLS AND MSCs AND WE RECENTLY 180 00:06:14,746 --> 00:06:16,348 HAVE SEEN CURATIVE GENE THERAPY 181 00:06:16,348 --> 00:06:16,948 APPROVALS FOR 182 00:06:16,948 --> 00:06:17,382 HEMOGLOBINOPATHIES. 183 00:06:17,382 --> 00:06:18,483 WE ARE FANCY NOW. 184 00:06:18,483 --> 00:06:19,818 WE DON'T JUST DO 185 00:06:19,818 --> 00:06:20,518 FIRST-GENERATION STUFF. 186 00:06:20,518 --> 00:06:23,421 WE ARE EDITING AND SNIPPING, 187 00:06:23,421 --> 00:06:24,122 BRINGING OUT OUR T CELLS. 188 00:06:24,122 --> 00:06:25,857 WE CAN DO LOTS OF THINGS TO MAKE 189 00:06:25,857 --> 00:06:27,459 THESE CELLS PERSIST LONGER IN 190 00:06:27,459 --> 00:06:27,726 THE BODY. 191 00:06:27,726 --> 00:06:29,494 WE CAN PUT IN KILL SWITCHES SO 192 00:06:29,494 --> 00:06:31,596 WHEN THEY START TO ACT UP AND 193 00:06:31,596 --> 00:06:33,365 GET OVER EXCITED, WE CAN TURN 194 00:06:33,365 --> 00:06:33,932 THEM OFF. 195 00:06:33,932 --> 00:06:35,634 SO WE ARE ABLE TO DO LOTS OF 196 00:06:35,634 --> 00:06:37,702 THINGS THAT WE RECOGNIZED WE 197 00:06:37,702 --> 00:06:40,138 NEED TO DO FROM BENCH TO BEDSIDE 198 00:06:40,138 --> 00:06:41,806 TRANSLATION AND THEN BACK TO 199 00:06:41,806 --> 00:06:42,007 BENCH. 200 00:06:42,007 --> 00:06:44,209 WE HAVE LOTS EVER BEST PRACTICE 201 00:06:44,209 --> 00:06:45,777 GUIDE LINES NOW ENHANCING 202 00:06:45,777 --> 00:06:46,011 SAFETY. 203 00:06:46,011 --> 00:06:47,879 WHEN I FIRST STARTED IN THIS 204 00:06:47,879 --> 00:06:49,447 FIELD, MY FIRST PATIENT HAD 205 00:06:49,447 --> 00:06:51,449 CYTOKINE RELEASE SYNDROME, IT 206 00:06:51,449 --> 00:06:53,652 WAS BEFORE THE PATIENT HAD 207 00:06:53,652 --> 00:06:55,253 CYTOKINE RELEASE SYNDROME. 208 00:06:55,253 --> 00:06:57,722 WE GAVE A TON OF STEROIDS, 209 00:06:57,722 --> 00:06:59,791 KILLED ALL THE T CELLS AND NOW 210 00:06:59,791 --> 00:07:01,559 WE HAVE ALGORITHMS. 211 00:07:01,559 --> 00:07:02,661 WHEN ANYONE CAN WALK INTO THE 212 00:07:02,661 --> 00:07:04,229 ROOM AND SEE A PATIENT AND 213 00:07:04,229 --> 00:07:05,363 RECOGNIZE THEY ARE HAVING 214 00:07:05,363 --> 00:07:07,732 SPECIFIC ADVERSE EVENT RELATED 215 00:07:07,732 --> 00:07:09,034 TO CAR-T CELLS AND KNOW WHAT TO 216 00:07:09,034 --> 00:07:10,302 DO TO TAKE CARE OF IT. 217 00:07:10,302 --> 00:07:11,937 AND WE ARE LOOKING AT SHARED 218 00:07:11,937 --> 00:07:14,372 CARE MODELS THAT ALLOW TREATMENT 219 00:07:14,372 --> 00:07:16,675 CLOSER TO HOME AND DEVELOPMENT. 220 00:07:16,675 --> 00:07:19,311 BEING HERE AT THE NIH WHERE YOU 221 00:07:19,311 --> 00:07:21,046 ALL ARE LITERALLY LEADING 222 00:07:21,046 --> 00:07:22,213 RESEARCH AND HAVE ACCESS TO SO 223 00:07:22,213 --> 00:07:23,815 MANY GROUNDBREAKING THERAPIES 224 00:07:23,815 --> 00:07:25,116 AND HAVE PEOPLE TRAVEL FROM ALL 225 00:07:25,116 --> 00:07:27,218 OVER THE COUNTRY AND THE WORLD, 226 00:07:27,218 --> 00:07:28,954 IT'S SIMILAR TO HOW WE ARE AT 227 00:07:28,954 --> 00:07:29,654 BAYLOR COLLEGE OF MEDICINE WHERE 228 00:07:29,654 --> 00:07:32,390 A LOT OF OUR TRIALS ARE THE ONLY 229 00:07:32,390 --> 00:07:33,258 ONES LIKE THEM IN THE WORLD. 230 00:07:33,258 --> 00:07:34,626 WE HAVE PEOPLE COMING FROM ALL 231 00:07:34,626 --> 00:07:35,327 OVER. 232 00:07:35,327 --> 00:07:36,962 SO IT IS IMPORTANT FOR US TO 233 00:07:36,962 --> 00:07:38,630 THINK ABOUT HOW WE CAN DO SHARED 234 00:07:38,630 --> 00:07:42,300 CARE MODELS SO WE DON'T REQUIRE 235 00:07:42,300 --> 00:07:44,202 PEOPLE TO UPROOT FOR SIX MONTHS 236 00:07:44,202 --> 00:07:46,504 TO HAVE ACCESS TO THESE 237 00:07:46,504 --> 00:07:46,771 THERAPIES. 238 00:07:46,771 --> 00:07:47,839 HOWEVER, THE REALITY IS, WE 239 00:07:47,839 --> 00:07:50,208 STILL ARE UNABLE TO GET THESE 240 00:07:50,208 --> 00:07:51,276 THERAPIES TO MANY 241 00:07:51,276 --> 00:07:52,811 UNDERREPRESENTED AND UNDER 242 00:07:52,811 --> 00:07:56,114 RESOURCED OR GEOGRAPHICALLY 243 00:07:56,114 --> 00:07:56,881 DISTANT PATIENTS. 244 00:07:56,881 --> 00:07:59,284 SO AT TEXAS CHILDREN'S, WE HAVE 245 00:07:59,284 --> 00:08:00,552 A CENTER FOR CELL AND GENE 246 00:08:00,552 --> 00:08:02,187 THERAPY THAT HAS BEEN AROUND FOR 247 00:08:02,187 --> 00:08:03,521 ABOUT 30 YEARS. 248 00:08:03,521 --> 00:08:06,224 WORKING IN HERPES VIRUSES, 249 00:08:06,224 --> 00:08:07,726 VIRUS-SPECIFIC T-CELLS AND THEN 250 00:08:07,726 --> 00:08:08,927 CAR-T CELLS. 251 00:08:08,927 --> 00:08:10,628 AND WE HAVE ALWAYS HAD A NUMBER 252 00:08:10,628 --> 00:08:12,731 OF ACTIVELY ENROLLING TRIALS. 253 00:08:12,731 --> 00:08:14,199 THE FIRST TIME I LEARNED ABOUT A 254 00:08:14,199 --> 00:08:17,435 CAR-T CELLS WAS TARGETING HER2 255 00:08:17,435 --> 00:08:20,338 ON A BREAST CANCER. 256 00:08:20,338 --> 00:08:22,540 TARGETING GD-2 ON A 257 00:08:22,540 --> 00:08:22,874 NEUROBLASTOMA. 258 00:08:22,874 --> 00:08:25,043 NOT THE CAR-T CELLS THAT HAVE 259 00:08:25,043 --> 00:08:27,278 COME TO THE FOREFRONT TARGETING 260 00:08:27,278 --> 00:08:27,479 CD19. 261 00:08:27,479 --> 00:08:30,081 THIS WAS A REALLY COOL 262 00:08:30,081 --> 00:08:32,317 FORTUITOUS PLACE FOR ME TO BE AT 263 00:08:32,317 --> 00:08:33,752 HOUSTON, AT BAYLOR COLLEGE OF 264 00:08:33,752 --> 00:08:34,753 MEDICINE BECAUSE I HAD THE 265 00:08:34,753 --> 00:08:35,754 OPPORTUNITY TO DO RESEARCH 266 00:08:35,754 --> 00:08:35,987 THERE. 267 00:08:35,987 --> 00:08:37,922 AND THE MAJORITY OF THE TRIALS 268 00:08:37,922 --> 00:08:40,158 THAT WE DO ARE FIRST-IN-HUMAN, 269 00:08:40,158 --> 00:08:42,260 THE MAJORITY ARE INVESTIGATOR 270 00:08:42,260 --> 00:08:42,527 INITIATED. 271 00:08:42,527 --> 00:08:43,728 SO OFTEN COME FROM FELLOWS WHO 272 00:08:43,728 --> 00:08:44,896 HAVE BEEN IN OUR PROGRAM AND 273 00:08:44,896 --> 00:08:47,432 THEN STAY ON AS FACULTY. 274 00:08:47,432 --> 00:08:50,468 AND WE OFTEN ARE ATTEMPTING TO 275 00:08:50,468 --> 00:08:52,470 TARGET CANCERS THAT HAVE PROVEN 276 00:08:52,470 --> 00:08:54,305 TO BE FAR MORE DIFFICULT TO 277 00:08:54,305 --> 00:08:56,307 TARGET THAN SOME OF THE ONES 278 00:08:56,307 --> 00:08:57,075 LIKE B-CELL MALIGNANCIES. 279 00:08:57,075 --> 00:08:59,277 AND WE ARE MOVING BEYOND CAR-T 280 00:08:59,277 --> 00:09:00,278 CELLS AND BEYOND CANCER. 281 00:09:00,278 --> 00:09:02,547 SO WE ALSO HAVE PROTOCOL THAT IS 282 00:09:02,547 --> 00:09:03,748 TARGET AUTOIMMUNE DISEASES AND 283 00:09:03,748 --> 00:09:07,619 WORK WITH A NUMBER OF DIFFERENT 284 00:09:07,619 --> 00:09:07,952 INVESTIGATORS. 285 00:09:07,952 --> 00:09:09,587 AND I'LL SAY THAT I PUT THIS IN 286 00:09:09,587 --> 00:09:12,090 HERE THAT WE HAVE ALL OF THIS 287 00:09:12,090 --> 00:09:13,124 HISTORY WITH THESE STUDIES 288 00:09:13,124 --> 00:09:15,193 BECAUSE I WANT TO POINT OUT THAT 289 00:09:15,193 --> 00:09:17,929 IT TAKES A FULL-BLOWN VILLAGE OR 290 00:09:17,929 --> 00:09:19,597 TWO OR THREE, TO GET SOME OF 291 00:09:19,597 --> 00:09:20,865 THESE TYPES OF THERAPIES FROM 292 00:09:20,865 --> 00:09:22,967 BENCH TO BEDSIDE AND I WAS 293 00:09:22,967 --> 00:09:25,070 FORTUNATE TO WORK LONG SIDE 294 00:09:25,070 --> 00:09:25,970 PEOPLE WHO COULD HELP ME DO 295 00:09:25,970 --> 00:09:26,604 THAT. 296 00:09:26,604 --> 00:09:28,406 SO, ONE OF THE CLINICAL TRIALS 297 00:09:28,406 --> 00:09:30,642 THAT I'M MOST PROUD OF IS A CD5 298 00:09:30,642 --> 00:09:33,645 CAR-T CELL FOR T-CELL 299 00:09:33,645 --> 00:09:33,978 MALIGNANCIES. 300 00:09:33,978 --> 00:09:35,380 ANYONE WHOEVER TAKEN CARE OF A 301 00:09:35,380 --> 00:09:38,883 PATIENT WITH RELAPSED OR 302 00:09:38,883 --> 00:09:41,186 REFRACTARY LYMPHOMA, KNOWS HOW 303 00:09:41,186 --> 00:09:43,188 AGGRESSIVE AND HORRIBLE THE 304 00:09:43,188 --> 00:09:44,389 OUTCOMES ARE IF YOU RELAPSE. 305 00:09:44,389 --> 00:09:46,324 SO IT TOOK A LOT TO GET THIS TO 306 00:09:46,324 --> 00:09:47,425 THE CLINIC. 307 00:09:47,425 --> 00:09:52,797 WE WOULD CREATE THESE CAR-T 308 00:09:52,797 --> 00:09:53,031 CELLS. 309 00:09:53,031 --> 00:09:54,799 THEY WOULD KILL EACH OTHER IN 310 00:09:54,799 --> 00:09:56,101 THE CULTURE BECAUSE THEY ARE 311 00:09:56,101 --> 00:09:58,570 LIKE, YOU EXPRESSED MY ANTIGEN 312 00:09:58,570 --> 00:09:58,903 I'M TARGETING. 313 00:09:58,903 --> 00:09:59,771 I FEEL YOU. 314 00:09:59,771 --> 00:10:00,905 WE COULDN'T EVEN GROW THE CELLS. 315 00:10:00,905 --> 00:10:02,707 WE HAD TO DO ALL KINDS OF 316 00:10:02,707 --> 00:10:03,908 DIFFERENT THINGS TO TRY TO MAKE 317 00:10:03,908 --> 00:10:04,843 THE CELLS GROW. 318 00:10:04,843 --> 00:10:06,878 AND WE FINALLY GOT IT. 319 00:10:06,878 --> 00:10:09,114 AND WHAT WE LEARNED FROM OUR 320 00:10:09,114 --> 00:10:10,381 PRECLINICAL WORK IN MICE IS 321 00:10:10,381 --> 00:10:11,516 THESE CELLS WEREN'T GOING TO 322 00:10:11,516 --> 00:10:14,152 LAST INDEFINITELY THE WAY CD19 323 00:10:14,152 --> 00:10:16,121 CAR-T CELLS LASTED. 324 00:10:16,121 --> 00:10:18,756 AND BECAUSE T-CELL LEUKEMIA AND 325 00:10:18,756 --> 00:10:20,525 LYMPHOMAS ARE SO AGGRESS I WAS, 326 00:10:20,525 --> 00:10:22,627 WE NEEDED TO HAVE A SAFEGUARD 327 00:10:22,627 --> 00:10:24,629 THAT PEOPLE SHOULD GO ON TO AN 328 00:10:24,629 --> 00:10:26,531 ALLOTRANSPLANT IF THEY ACHIEVE 329 00:10:26,531 --> 00:10:26,798 REMISSION. 330 00:10:26,798 --> 00:10:30,068 AND WE INITIALLY REALLY WANTED 331 00:10:30,068 --> 00:10:32,103 TO MAKE SURE THAT WE WERE 332 00:10:32,103 --> 00:10:33,905 TARGETING TUMORS THAT BROADLY 333 00:10:33,905 --> 00:10:37,542 EXPRESSED CD5 AND THE FDA AND US 334 00:10:37,542 --> 00:10:39,511 AGREED THAT THIS WAS THE 335 00:10:39,511 --> 00:10:40,678 FIRST-IN-HUMAN TRIAL WE NEEDED 336 00:10:40,678 --> 00:10:42,547 TO HAVE TRANSPLANT AS A 337 00:10:42,547 --> 00:10:44,482 SAFEGUARD IN CASE OUR CAR-T 338 00:10:44,482 --> 00:10:49,487 CELLS WENT CRAZY AND STARTED 339 00:10:49,487 --> 00:10:50,421 TARGETING NORMAL T CELLS PRONG 340 00:10:50,421 --> 00:10:52,190 LONGED AND CAUSED T-CELL 341 00:10:52,190 --> 00:10:52,423 APLASIA. 342 00:10:52,423 --> 00:10:55,093 SO I POINT THIS OUT BECAUSE IT 343 00:10:55,093 --> 00:10:56,728 IS STRATEGY FROM WHAT WE LEARNED 344 00:10:56,728 --> 00:10:57,495 AT THE BENCH. 345 00:10:57,495 --> 00:10:58,997 WE KNEW WE NEEDED TO WRITE IT 346 00:10:58,997 --> 00:11:01,232 INTO OUR TRIAL TO MAKE SURE IT 347 00:11:01,232 --> 00:11:01,599 WAS SAFE. 348 00:11:01,599 --> 00:11:04,002 AND SO, THIS TRIAL WE NOW 349 00:11:04,002 --> 00:11:06,504 TREATED 26 PATIENTS ON. 350 00:11:06,504 --> 00:11:07,972 WE HAVE BEEN SURPRISED AT HOW 351 00:11:07,972 --> 00:11:11,176 GOOD THE OUTCOMES ARE. 352 00:11:11,176 --> 00:11:11,843 BECAUSE WE OPERATE ALMOST AS 353 00:11:11,843 --> 00:11:14,412 WHAT I LIKE TO CALL A 354 00:11:14,412 --> 00:11:16,247 CENTRALIZED ACADEMIC MODEL WHERE 355 00:11:16,247 --> 00:11:18,483 WE ARE SIMILAR TO THE NIH IN THE 356 00:11:18,483 --> 00:11:19,951 SENSE THAT PEOPLE WILL OFTEN 357 00:11:19,951 --> 00:11:22,420 COME TO US BUT BECAUSE WE CAN 358 00:11:22,420 --> 00:11:25,490 MAKE THESE CELLS WITHOUT THE 359 00:11:25,490 --> 00:11:26,658 PROCESS OF LUKE PHORESIES, WE 360 00:11:26,658 --> 00:11:31,095 CAN SEND A KIT BY FED-EX AND HAS 361 00:11:31,095 --> 00:11:31,796 THE TUBES AND CONSENT AND THIS 362 00:11:31,796 --> 00:11:33,665 WAS SOMETHING THAT WAS REALLY 363 00:11:33,665 --> 00:11:34,332 IMPORTANT FOR US BECAUSE WE 364 00:11:34,332 --> 00:11:35,533 WANTED TO MAKE SURE THAT 365 00:11:35,533 --> 00:11:37,035 PATIENTS DID NOT HAVE TO UPROOT 366 00:11:37,035 --> 00:11:39,837 AND COME TO US TO GET FERRIESED 367 00:11:39,837 --> 00:11:42,106 AND GO BACK AND HAVE TO WAIT FOR 368 00:11:42,106 --> 00:11:42,774 THE CELLS. 369 00:11:42,774 --> 00:11:43,608 WE SEND A KIT. 370 00:11:43,608 --> 00:11:45,543 YOU CAN SEND PERIPHERAL BLOOD 371 00:11:45,543 --> 00:11:48,146 DRAWN FROM A VEIN OR EXISTING IV 372 00:11:48,146 --> 00:11:49,414 OR LINE BACK TO US. 373 00:11:49,414 --> 00:11:50,448 WE MANUFACTURE THE CELLS AND WE 374 00:11:50,448 --> 00:11:51,950 HAVE A COUPLE OF STUD -ES THAT 375 00:11:51,950 --> 00:11:54,452 ARE MULTICENTER OF THE SO PEOPLE 376 00:11:54,452 --> 00:11:56,354 DON'T HAVE TO TRAVEL TO THE HEAT 377 00:11:56,354 --> 00:11:58,423 AND HUMIDITY OF TEXAS IN AUGUST 378 00:11:58,423 --> 00:12:02,427 TO GET THEIR CELLS, WHICH ANYONE 379 00:12:02,427 --> 00:12:04,028 WHOEVER BEEN THERE KNOWS IT'S 380 00:12:04,028 --> 00:12:04,729 REALLY IMPORTANT. 381 00:12:04,729 --> 00:12:06,431 THE BREAKDOWN OF THE TRIAL IS 382 00:12:06,431 --> 00:12:08,866 SIMILAR TO MOST CAR-T CELL 383 00:12:08,866 --> 00:12:09,100 TRIALS. 384 00:12:09,100 --> 00:12:11,736 WE PREP THE BODY, GIVE A COUPLE 385 00:12:11,736 --> 00:12:14,606 OF DAYS OF CHEMO TO GET THE 386 00:12:14,606 --> 00:12:16,374 HOMEOSTATIC CYTOKINES TO HELP 387 00:12:16,374 --> 00:12:17,375 THE CAR-T CELLS GROW AND EXPAND 388 00:12:17,375 --> 00:12:19,611 IN THE BODY. 389 00:12:19,611 --> 00:12:21,479 WE IN FUSE THE CELLS AND DO LOTS 390 00:12:21,479 --> 00:12:22,947 OF CORRELATIVE ANALYSIS AND THEN 391 00:12:22,947 --> 00:12:24,148 WE CHECK RESPONSE. 392 00:12:24,148 --> 00:12:26,951 AND WE HAVE HAD REMARKABLE 393 00:12:26,951 --> 00:12:27,218 RESPONSES. 394 00:12:27,218 --> 00:12:29,954 I'M GOING TO TRY TO USE VERY 395 00:12:29,954 --> 00:12:31,889 CLEAR INSTRUCTIONS OUR AV FOLKS 396 00:12:31,889 --> 00:12:33,157 GAVE ME ABOUT THIS POINTER. 397 00:12:33,157 --> 00:12:35,293 SO YOU CAN SEE PRE CAR T, YOU 398 00:12:35,293 --> 00:12:38,029 DON'T HAVE TO BE A RADIOLOGIST 399 00:12:38,029 --> 00:12:41,032 TO SEE THIS HUGE LIMPOPATHY, 400 00:12:41,032 --> 00:12:42,367 REFRACTARY T-CELL LYMPHOMA FROM 401 00:12:42,367 --> 00:12:43,968 A PATIENT WHO IS VERY HEAVILY 402 00:12:43,968 --> 00:12:44,769 PRE TREATED. 403 00:12:44,769 --> 00:12:47,538 THIS IS PRE-CAR T. 404 00:12:47,538 --> 00:12:49,941 AND JUST 4 WEEKS AFTER 405 00:12:49,941 --> 00:12:52,043 COMPLETELY ERADICATED BY CAR-T 406 00:12:52,043 --> 00:12:52,310 CELLS. 407 00:12:52,310 --> 00:12:54,412 WE SEEN REALLY PROMISING 408 00:12:54,412 --> 00:12:55,913 RESPONSES, ESPECIALLY IN 409 00:12:55,913 --> 00:12:57,749 PATIENTS WITH MATURE T-CELL 410 00:12:57,749 --> 00:12:59,984 LYMPHOMA, A LITTLE BIT OF A 411 00:12:59,984 --> 00:13:01,552 DIFFERENT BIOLOGY THAN IMMATURE 412 00:13:01,552 --> 00:13:04,155 AND ALSO BENCH TO BEDSIDE 413 00:13:04,155 --> 00:13:05,256 CHANGED OUR MANUFACTURE BECAUSE 414 00:13:05,256 --> 00:13:06,724 WE FOUND THAT WHEN WE LEFT THESE 415 00:13:06,724 --> 00:13:09,160 CELLS IN CULTURE EVEN JUST FOR A 416 00:13:09,160 --> 00:13:10,795 WEEK AFTER TRANSDUCING WITH THE 417 00:13:10,795 --> 00:13:14,098 CAR, THEY WERE BECOMING OVERLY 418 00:13:14,098 --> 00:13:14,365 EXHAUSTED. 419 00:13:14,365 --> 00:13:16,701 THEY WERE TOO EXHAUSTED, HAVING 420 00:13:16,701 --> 00:13:18,336 PARTIES, GETTING TIRED AND WE 421 00:13:18,336 --> 00:13:20,271 PUT THEM IN THE BODY AND THEY'RE 422 00:13:20,271 --> 00:13:21,439 LIKE, WE'LL JUST TAKE A NAP. 423 00:13:21,439 --> 00:13:22,407 WE HAD TO SHORTEN THE 424 00:13:22,407 --> 00:13:22,740 MANUFACTURE. 425 00:13:22,740 --> 00:13:24,942 WE ADDED CHEMICAL IN HI 426 00:13:24,942 --> 00:13:26,144 ABOUTITION TO STOP THEM FROM 427 00:13:26,144 --> 00:13:27,312 GETTING OVER EXCITED WITHOUT 428 00:13:27,312 --> 00:13:28,980 THEIR TARGET. 429 00:13:28,980 --> 00:13:30,648 SO WE ALSO HAVE IA NUMBER OF 430 00:13:30,648 --> 00:13:32,483 STUDIES TARGETING OTHER 431 00:13:32,483 --> 00:13:33,051 MALIGNANCIES THAT ARE 432 00:13:33,051 --> 00:13:33,418 REFRACTARY. 433 00:13:33,418 --> 00:13:37,422 WE HAVE A CD30 CAR-T CELL TRIAL. 434 00:13:37,422 --> 00:13:39,957 YOU ALSO HAVE THAT HERE AT THE 435 00:13:39,957 --> 00:13:40,124 NIH. 436 00:13:40,124 --> 00:13:42,460 WE HAVE BOTH HAD VERY PROMISING 437 00:13:42,460 --> 00:13:44,162 RESULTS WHERE WE ARE SEEING 438 00:13:44,162 --> 00:13:45,697 PATIENTS THAT HAVE EVIDENCE OF 439 00:13:45,697 --> 00:13:49,300 DISEASE THAT IS COMPLETELY 440 00:13:49,300 --> 00:13:49,600 ERADICATED. 441 00:13:49,600 --> 00:13:51,169 AND, WHAT HAS BEEN REALLY 442 00:13:51,169 --> 00:13:52,136 CHALLENGING, ANYONE WHO IS 443 00:13:52,136 --> 00:13:53,271 INTERESTED IN CELL AND GENE 444 00:13:53,271 --> 00:13:54,405 THERAPIES, WHICH I KNOW A COUPLE 445 00:13:54,405 --> 00:13:57,608 OF FELLOWS ARE, YOU KNOW HOW HOW 446 00:13:57,608 --> 00:13:59,043 CHALLENGING IT IS TO USE THESE 447 00:13:59,043 --> 00:14:00,812 THERAPIES TO TARGETS SOLID 448 00:14:00,812 --> 00:14:02,847 TUMORS AND BRAIN TUMORS. 449 00:14:02,847 --> 00:14:04,582 LEUKEMIA IS JUST FLOATING AROUND 450 00:14:04,582 --> 00:14:06,017 IN THE BLOOD, HANGING AROUND IN 451 00:14:06,017 --> 00:14:07,285 THE BONE MARROW. 452 00:14:07,285 --> 00:14:10,722 MY SOLID TUMORS ARE LIKE, YOU DO 453 00:14:10,722 --> 00:14:10,988 LEUKEMIA. 454 00:14:10,988 --> 00:14:12,824 THERE IS SO MUCH STUDY. 455 00:14:12,824 --> 00:14:15,026 EVEN IF I HAVE AMAZING OUTCOMES, 456 00:14:15,026 --> 00:14:18,029 THEY ARE LIKE, WELL -- TOUCHE, 457 00:14:18,029 --> 00:14:18,596 OKAY? 458 00:14:18,596 --> 00:14:20,164 BECAUSE CAR-T CELLS AND CELL 459 00:14:20,164 --> 00:14:21,399 INDUCED THERAPIES TO GET INTO 460 00:14:21,399 --> 00:14:23,868 THE SOLID TUMOR, YOU HAVE TO 461 00:14:23,868 --> 00:14:28,406 DEAL WITH A EXTREMELY HOSTILE 462 00:14:28,406 --> 00:14:28,706 ENVIRONMENT. 463 00:14:28,706 --> 00:14:30,575 THERE ARE SECURITY OUTSIDE, 464 00:14:30,575 --> 00:14:31,843 THERE IS GANG MEMBERS TRYING TO 465 00:14:31,843 --> 00:14:32,577 TAKE YOU OUT. 466 00:14:32,577 --> 00:14:34,746 IT'S REALLY HARD. 467 00:14:34,746 --> 00:14:36,114 WE SEEN PROMISING RESULTS IN 468 00:14:36,114 --> 00:14:37,615 SOLID TUMORS WHERE THIS IS A 469 00:14:37,615 --> 00:14:39,450 PATIENT WITH GLIOBLASTOMA WHICH 470 00:14:39,450 --> 00:14:40,952 WE KNOW HOW TERRIBLE IT IS. 471 00:14:40,952 --> 00:14:43,755 AND JUST SEEING STABLE DISEASE 472 00:14:43,755 --> 00:14:45,223 AND SEEING STRINGAGE CAN OFTEN 473 00:14:45,223 --> 00:14:45,490 BE A WIN. 474 00:14:45,490 --> 00:14:48,159 AND WE SEEN THIS IN 475 00:14:48,159 --> 00:14:51,896 NEUROBLASTOMA AND RIBOMY 476 00:14:51,896 --> 00:14:52,430 SARCOMA. 477 00:14:52,430 --> 00:14:54,532 A LOT OF THE FIELD SAYING WE CAN 478 00:14:54,532 --> 00:14:55,967 TARGET B-CELL MALIGNANCIES BUT 479 00:14:55,967 --> 00:14:57,502 WE HAVE TO THINK ABOUT THESE 480 00:14:57,502 --> 00:14:59,170 OTHER TUMORS AND WE HAVE TO 481 00:14:59,170 --> 00:15:00,772 THINK ABOUT WAYS WE CAN MAKE OUR 482 00:15:00,772 --> 00:15:03,441 CAR-T CELLS MORE POWERFUL, WAYS 483 00:15:03,441 --> 00:15:06,477 WE CAN COMBINE THE THERAPY WITH 484 00:15:06,477 --> 00:15:07,779 RADIATION, WHICH CHECKPOINT 485 00:15:07,779 --> 00:15:11,015 INHIBITION TO PRIME THE SPACE. 486 00:15:11,015 --> 00:15:14,152 WE ALSO HAVE TO DO THE OFF THE 487 00:15:14,152 --> 00:15:16,687 SHELF -- DO YOU HAVE COSTCO? 488 00:15:16,687 --> 00:15:17,088 SAMS? 489 00:15:17,088 --> 00:15:18,156 OKAY. 490 00:15:18,156 --> 00:15:19,791 THE COSTCO EDITION WHERE YOU CAN 491 00:15:19,791 --> 00:15:21,526 SAY, MY PATIENT HAS THIS, I NEED 492 00:15:21,526 --> 00:15:22,160 THIS AND THAT. 493 00:15:22,160 --> 00:15:25,496 SO WE HAVE A LOT OF OFF THE 494 00:15:25,496 --> 00:15:25,897 SHELF PROTOCOLS. 495 00:15:25,897 --> 00:15:29,467 ONE OF THE FIRST I DID WAS OFF 496 00:15:29,467 --> 00:15:29,734 THE SHELF. 497 00:15:29,734 --> 00:15:32,503 WE USED PARTIAL HLA MATCHING BUT 498 00:15:32,503 --> 00:15:34,939 WE DO VIRUS-SPECIFIC T CELLS 499 00:15:34,939 --> 00:15:36,007 BECAUSE THAT NATIVE T-CELL 500 00:15:36,007 --> 00:15:36,874 RECEPTOR WILL BE TRAINED TO 501 00:15:36,874 --> 00:15:38,476 TARGET VIRUS. 502 00:15:38,476 --> 00:15:40,244 SO SHOULD NOT CAUSE 503 00:15:40,244 --> 00:15:40,778 GRAFT-VERSUS-HOST DISEASE. 504 00:15:40,778 --> 00:15:43,481 AND THEN YOU CAN EQUIP THE CELL 505 00:15:43,481 --> 00:15:45,283 WITH VIRUS SPECIFIC T CELLS THAT 506 00:15:45,283 --> 00:15:45,883 HAVE A CAR ON THEM. 507 00:15:45,883 --> 00:15:47,318 WE CAN PUT THEM INTO THE BODY 508 00:15:47,318 --> 00:15:48,686 AND HAVE GOOD RESPONSES. 509 00:15:48,686 --> 00:15:49,887 THE COOL THING ABOUT THIS IS 510 00:15:49,887 --> 00:15:52,390 THAT IT'S NOT AS PERSONALIZED. 511 00:15:52,390 --> 00:15:53,591 YOU CAN SCALE IT UP. 512 00:15:53,591 --> 00:15:57,428 YOU DO REPEAT DOSING AND YOU CAN 513 00:15:57,428 --> 00:15:58,596 LITERALLY DERIVE UNIVERSAL 514 00:15:58,596 --> 00:16:01,599 PRODUCTS FROM SINGLE OR FEW 515 00:16:01,599 --> 00:16:02,266 HEALTHY DONORS. 516 00:16:02,266 --> 00:16:04,035 THERETO IS IT A LOT OF CRISPR 517 00:16:04,035 --> 00:16:07,305 EDILATING TO EDIT OUT THE TCR 518 00:16:07,305 --> 00:16:08,072 AND EQUIP YOUR CELLS WITH THE 519 00:16:08,072 --> 00:16:10,074 ABILITY TO NOT CAUSE 520 00:16:10,074 --> 00:16:11,209 GRAFT-VERSUS-HOST DISEASE IN A 521 00:16:11,209 --> 00:16:13,044 PATIENT, BUT ALSO TO NOT GET 522 00:16:13,044 --> 00:16:14,912 MEDICINALLY REJECTED BY 523 00:16:14,912 --> 00:16:17,482 SOMEONE'S IMMUNE SYSTEM. 524 00:16:17,482 --> 00:16:19,717 AND SO AT OUR CENTER, ONE OF THE 525 00:16:19,717 --> 00:16:22,220 BIG PUSHES AND THINGS WE DO IS 526 00:16:22,220 --> 00:16:24,021 TRY TO MAKE THESE CELLS FROM 527 00:16:24,021 --> 00:16:27,325 PERIPHERAL BLOOD AS MUCH AS 528 00:16:27,325 --> 00:16:28,426 POSSIBLE BECAUSE HOW MANY OF 529 00:16:28,426 --> 00:16:31,295 Y'ALL IN HERE HAVE KIDS? 530 00:16:31,295 --> 00:16:32,396 A FEW PEOPLE. 531 00:16:32,396 --> 00:16:33,764 I DON'T HAVE CHILDREN BUT I'M 532 00:16:33,764 --> 00:16:34,799 LIKE A CHILD. 533 00:16:34,799 --> 00:16:36,334 SO ME HAVING TO GET UP AND GET 534 00:16:36,334 --> 00:16:37,802 ON THE PLANE, MAKE IT TO THE 535 00:16:37,802 --> 00:16:41,672 AIRPORT ON TIME, GO TO GET A 536 00:16:41,672 --> 00:16:42,540 FREEZEIS, IT'S A LOT. 537 00:16:42,540 --> 00:16:44,141 WE TRY TO THINK ABOUT WHAT THE 538 00:16:44,141 --> 00:16:45,643 PATIENT AND FAMILY NEEDS AND THE 539 00:16:45,643 --> 00:16:46,811 FACT THESE PATIENTS REFERRED TO 540 00:16:46,811 --> 00:16:48,913 US ARE VERY WELL TAKEN CARE OF 541 00:16:48,913 --> 00:16:51,115 AT THEIR HOME INSTITUTION BY 542 00:16:51,115 --> 00:16:52,650 THEIR HOME PROVIDERS AND THEY 543 00:16:52,650 --> 00:16:54,719 ARE PERFECTLY CAPABLE OF BEING 544 00:16:54,719 --> 00:16:55,820 ABLE TO SEND THAT PERIPHERAL 545 00:16:55,820 --> 00:16:56,587 BLOOD TO US. 546 00:16:56,587 --> 00:16:59,490 SO THIS ALLOWS US TO SEND THESE 547 00:16:59,490 --> 00:17:01,425 KITS, GET THE BLOOD SENT BACK TO 548 00:17:01,425 --> 00:17:03,427 US, MANUFACTURE AND WE STILL ARE 549 00:17:03,427 --> 00:17:05,296 IN THAT CENTRALIZED ACADEMIC 550 00:17:05,296 --> 00:17:06,130 MANUFACTURE WHERE YOU STILL HAVE 551 00:17:06,130 --> 00:17:09,300 TO TRAVEL TO US FOR THE PHASE I 552 00:17:09,300 --> 00:17:11,035 TRIALINGS, WHICH IS PROBABLY 553 00:17:11,035 --> 00:17:11,335 APPROPRIATE. 554 00:17:11,335 --> 00:17:13,538 BUT IT ALLOWS US TO TARGET A 555 00:17:13,538 --> 00:17:14,805 BUNCH OF DIFFERENT TYPES OF 556 00:17:14,805 --> 00:17:15,072 CANCER. 557 00:17:15,072 --> 00:17:16,440 WE HAVE A HUGE CENTER WITH LOTS 558 00:17:16,440 --> 00:17:17,842 OF FOLKS WORKING ON THESE. 559 00:17:17,842 --> 00:17:20,378 SO, I WANTED TO -- LOOKING AT 560 00:17:20,378 --> 00:17:24,348 ONE STUDY AND LOOKING AT A YEAR 561 00:17:24,348 --> 00:17:25,850 IN HOW FAR PATIENTS COME FROM. 562 00:17:25,850 --> 00:17:27,919 SO TEXAS IS OBVIOUSLY QUITE 563 00:17:27,919 --> 00:17:28,119 LARGE. 564 00:17:28,119 --> 00:17:29,487 THE DARKER THE BLUE THE MORE 565 00:17:29,487 --> 00:17:30,955 PATIENTS THAT COME FROM THERE. 566 00:17:30,955 --> 00:17:32,823 WHILE MOST OF THE PATIENTS MAY 567 00:17:32,823 --> 00:17:35,159 COME FROM HOUSTON, 21% CAME FROM 568 00:17:35,159 --> 00:17:38,329 THE REST OF TEXAS BUT 28% FROM 569 00:17:38,329 --> 00:17:38,963 22 OTHER STATES. 570 00:17:38,963 --> 00:17:40,831 IT'S NOT BECAUSE THEY WANTED TO 571 00:17:40,831 --> 00:17:42,800 COME TO TEXAS IN AUGUST. 572 00:17:42,800 --> 00:17:44,635 IT'S BECAUSE THEY LITERALLY HAD 573 00:17:44,635 --> 00:17:45,770 NO OTHER TREATMENT OPTIONS THAT 574 00:17:45,770 --> 00:17:46,938 WERE VIABLE. 575 00:17:46,938 --> 00:17:49,674 AND SO, IT ALWAYS STRUCK ME THAT 576 00:17:49,674 --> 00:17:51,776 WE'RE ABLE TO DO THIS REALLY 577 00:17:51,776 --> 00:17:54,779 FANCY SCIENCE BUT WE STILL ARE 578 00:17:54,779 --> 00:17:55,980 LITERALLY UPROOTING PEOPLE FROM 579 00:17:55,980 --> 00:17:57,415 THEIR LIVES TO COME AND TO 580 00:17:57,415 --> 00:17:59,717 RECEIVE THESE THERAPIES. 581 00:17:59,717 --> 00:18:01,719 AND SO PATIENT ACCESS TO CELL 582 00:18:01,719 --> 00:18:03,321 THERAPIES INCLUDING CAR-T CELLS, 583 00:18:03,321 --> 00:18:06,290 IS TRULY AN UPHILL BATTLE AND 584 00:18:06,290 --> 00:18:07,625 THERE ARE SO MANY ROAD BLOCKS 585 00:18:07,625 --> 00:18:09,026 THAT ARE ANTICIPATED AND 586 00:18:09,026 --> 00:18:10,261 UNANTICIPATED AND NOT JUST FOR 587 00:18:10,261 --> 00:18:12,863 THE PATIENTS, BUT ALSO FOR THE 588 00:18:12,863 --> 00:18:13,130 PROVIDERS. 589 00:18:13,130 --> 00:18:15,866 AND THEN TRICKLE DOWN TO THE 590 00:18:15,866 --> 00:18:16,167 RESEARCHERS. 591 00:18:16,167 --> 00:18:19,337 SO I'M CONSTANTLY TALKING WITH 592 00:18:19,337 --> 00:18:21,272 MY BASIC SCIENCE COLLEAGUES 593 00:18:21,272 --> 00:18:22,974 ABOUT THE FACT THAT WE ARE 594 00:18:22,974 --> 00:18:23,174 READY. 595 00:18:23,174 --> 00:18:23,741 WE ARE OPEN. 596 00:18:23,741 --> 00:18:26,177 WE ARE READY TO GET THE TRIAL 597 00:18:26,177 --> 00:18:26,544 GOING. 598 00:18:26,544 --> 00:18:28,212 AND THEN THEY ARE LIKE, WHY 599 00:18:28,212 --> 00:18:29,046 HAVEN'T WE ACCRUED? 600 00:18:29,046 --> 00:18:30,348 WHY HAVEN'T WE HAD THIS? 601 00:18:30,348 --> 00:18:31,682 WE HAVE TO TALK ABOUT SOME OF 602 00:18:31,682 --> 00:18:33,417 THESE BARRIERS SO IT MATTERS TO 603 00:18:33,417 --> 00:18:33,684 EVERYONE. 604 00:18:33,684 --> 00:18:35,286 SO I THINK EVERYONE IS FAMILIAR 605 00:18:35,286 --> 00:18:38,122 WITH THE JOURNEY THAT THE CELLS 606 00:18:38,122 --> 00:18:38,889 TAKE. 607 00:18:38,889 --> 00:18:40,358 WE COLLECT THE CELLS, WE SEND 608 00:18:40,358 --> 00:18:42,093 THEM TO A MANUFACTURING 609 00:18:42,093 --> 00:18:42,893 FACILITY. 610 00:18:42,893 --> 00:18:44,695 IF IT'S OUTSIDE MANUFACTURE FOR 611 00:18:44,695 --> 00:18:46,163 ONES WE ARE MANUFACTURING 612 00:18:46,163 --> 00:18:46,564 OURSELVES. 613 00:18:46,564 --> 00:18:48,332 WE PUT THE CAR GENE IN THERE. 614 00:18:48,332 --> 00:18:49,934 WE GROW THE CELLS AND GIVE THEM 615 00:18:49,934 --> 00:18:50,301 BACK. 616 00:18:50,301 --> 00:18:52,303 BUT, I WANT TO TALK A LITTLE BIT 617 00:18:52,303 --> 00:18:54,672 ABOUT WHAT HAPPENS TO THE 618 00:18:54,672 --> 00:18:55,806 PATIENT AND THE PROVIDERS. 619 00:18:55,806 --> 00:18:57,208 SO FIRST THE PREPARATION. 620 00:18:57,208 --> 00:19:00,111 SO IF YOU EVER HAD A REFRACTARY 621 00:19:00,111 --> 00:19:01,612 PATIENT THAT IS ELIGIBLE FOR A 622 00:19:01,612 --> 00:19:03,280 CLINICAL TRIAL THAT IS NOT 623 00:19:03,280 --> 00:19:05,683 AVAILABLE AT YOUR SITE, YOU KNOW 624 00:19:05,683 --> 00:19:08,185 THAT YOU AND YOUR NURSE 625 00:19:08,185 --> 00:19:09,286 COORDINATOR AND YOUR ATTENDING 626 00:19:09,286 --> 00:19:13,290 AND YOUR FELLOW AND YOUR SOCIAL 627 00:19:13,290 --> 00:19:13,824 WORKER AND YOUR FINANCIAL 628 00:19:13,824 --> 00:19:14,625 COUNCILOR HAVE A LOT OF STUFF TO 629 00:19:14,625 --> 00:19:16,694 DO TO WORK WITH THAT FAMILY TO 630 00:19:16,694 --> 00:19:18,095 TRY TO IDENTIFY EVEN A TREATMENT 631 00:19:18,095 --> 00:19:18,295 SITE. 632 00:19:18,295 --> 00:19:20,131 YOU KNOW THERE MAY NOT BE A SPOT 633 00:19:20,131 --> 00:19:21,465 AVAILABLE ON A CLINICAL TRIAL 634 00:19:21,465 --> 00:19:22,600 ESPECIALLY IN EARLY PHASE I. 635 00:19:22,600 --> 00:19:25,136 THEN YOU HAVE TO COORDINATE THE 636 00:19:25,136 --> 00:19:25,803 COLLECTION WHETHER IT'S 637 00:19:25,803 --> 00:19:27,171 HAPPENING AT YOUR SITE OR 638 00:19:27,171 --> 00:19:28,005 SOMEWHERE ELSE. 639 00:19:28,005 --> 00:19:30,374 AND YOU OFTEN HAVE TO GET 640 00:19:30,374 --> 00:19:30,808 INSURANCE APPROVAL. 641 00:19:30,808 --> 00:19:32,410 SO EVEN THOUGH I RUN CLINICAL 642 00:19:32,410 --> 00:19:34,879 TRIALS THAT ARE QUALIFIED 643 00:19:34,879 --> 00:19:36,647 CLINICAL TRIALS THAT THE ACTUAL 644 00:19:36,647 --> 00:19:39,050 RESEARCH IS COVERED BY THE 645 00:19:39,050 --> 00:19:40,785 CLINICAL TRIAL, YOU STILL OFTEN 646 00:19:40,785 --> 00:19:43,387 HAVE TO GET COVERAGE FOR ROUTINE 647 00:19:43,387 --> 00:19:44,689 CLINICAL COSTS ASSOCIATED WITH 648 00:19:44,689 --> 00:19:45,923 THAT CLINICAL TRIAL. 649 00:19:45,923 --> 00:19:47,425 FOR A PATIENT THAT IS COMING 650 00:19:47,425 --> 00:19:49,794 FROM OUT OF STATE AND OUT OF 651 00:19:49,794 --> 00:19:50,895 NETWORK, ALMOST UNIVERSALLY THE 652 00:19:50,895 --> 00:19:53,230 FIRST ANSWER IS, ABSOLUTELY NOT. 653 00:19:53,230 --> 00:19:54,498 AND Y'ALL ARE AT THE NIH WHERE 654 00:19:54,498 --> 00:19:55,700 YOU COVER A LOT OF DIFFERENT 655 00:19:55,700 --> 00:19:56,801 THINGS BUT I'M GOING TO TALK 656 00:19:56,801 --> 00:19:58,602 ABOUT THAT TOO BECAUSE IT'S NOT 657 00:19:58,602 --> 00:19:59,603 AS OPEN AND SHUT. 658 00:19:59,603 --> 00:20:02,239 BUT THE POINT IS THE TREATING 659 00:20:02,239 --> 00:20:03,240 PROVIDERS, PATIENTS AND 660 00:20:03,240 --> 00:20:04,208 CAREGIVERS, THEY HAVE VERY 661 00:20:04,208 --> 00:20:05,443 LIMITED CONTROL IN THIS ASPECT 662 00:20:05,443 --> 00:20:06,310 OF THE PROCESS. 663 00:20:06,310 --> 00:20:08,079 THEN, YOU'RE LIKE, OKAY, WE MADE 664 00:20:08,079 --> 00:20:08,245 IT. 665 00:20:08,245 --> 00:20:09,814 WE COLLECTED THE CELLS. 666 00:20:09,814 --> 00:20:10,548 OKAY. 667 00:20:10,548 --> 00:20:11,615 NOW WE'RE IN THE MANUFACTURE 668 00:20:11,615 --> 00:20:14,051 PERIOD, RIGHT? 669 00:20:14,051 --> 00:20:15,953 AND ANYONE WHO HAS REFERRED 670 00:20:15,953 --> 00:20:17,421 SOMEONE FOR A CELL THERAPY 671 00:20:17,421 --> 00:20:18,622 CLINICAL TRIALS KNOW SYSTEM THE 672 00:20:18,622 --> 00:20:20,191 AMOUNT OF TIME QUOTED TO YOU CAN 673 00:20:20,191 --> 00:20:21,325 VARY GREATLY. 674 00:20:21,325 --> 00:20:22,893 WELL, IT TAKES A WEEK AND A HALF 675 00:20:22,893 --> 00:20:24,995 TO MAKE THE CELLS BUT THEN WE 676 00:20:24,995 --> 00:20:27,531 HAVE TO DO A CULTURE FOR 677 00:20:27,531 --> 00:20:29,033 AUTONOMOUS GROWTH, THREE WEEKS, 678 00:20:29,033 --> 00:20:30,134 QUALITY ASSURANCE THAT WILL TAKE 679 00:20:30,134 --> 00:20:30,801 THIS MUCH TIME. 680 00:20:30,801 --> 00:20:33,137 SO IT OFTEN WILL TAKE 4-12 681 00:20:33,137 --> 00:20:33,337 WEEKS. 682 00:20:33,337 --> 00:20:35,539 THESE ARE REFRACTARY PATIENTS. 683 00:20:35,539 --> 00:20:36,941 SO WE KNOW WHAT IS HAPPENING 684 00:20:36,941 --> 00:20:38,209 DURING THAT TIME POINT. 685 00:20:38,209 --> 00:20:40,811 BUT IMPORTANTLY, THE PRIORITY IS 686 00:20:40,811 --> 00:20:42,513 OFTEN DEPENDENT ON THE ORDER OF 687 00:20:42,513 --> 00:20:44,849 REFERRAL NOT THE CLINICAL NEED. 688 00:20:44,849 --> 00:20:46,217 SO EVEN IF IT'S AN 689 00:20:46,217 --> 00:20:47,151 INVESTIGATIONAL TRIAL AND YOU'RE 690 00:20:47,151 --> 00:20:49,120 TALKING TO THAT INVESTIGATOR, IT 691 00:20:49,120 --> 00:20:50,755 IS VERY COMMON TO SAY HOW MANY 692 00:20:50,755 --> 00:20:51,989 PATIENTS ARE ON THE WAIT LIST 693 00:20:51,989 --> 00:20:54,525 FOR THIS PHASE I TRIAL TO TREAT 694 00:20:54,525 --> 00:20:55,826 UP TO 26 PATIENTS? 695 00:20:55,826 --> 00:20:57,528 WELL, WE HAVE 9 PATIENTS ON THE 696 00:20:57,528 --> 00:20:58,496 WAIT LIST. 697 00:20:58,496 --> 00:21:00,164 FOR YOUR PATIENT AT THAT MOMENT, 698 00:21:00,164 --> 00:21:03,000 THAT MAY SEEM LIKE IT'S NOT 699 00:21:03,000 --> 00:21:03,868 REALLY AN OPTION. 700 00:21:03,868 --> 00:21:05,569 AND THE MORE COMPLEX, WHEN WE 701 00:21:05,569 --> 00:21:08,105 GET FANCY IN THE LAB AND WE'RE 702 00:21:08,105 --> 00:21:09,940 EDITING AND SOUPING UP THE CAR-T 703 00:21:09,940 --> 00:21:11,542 CELLS, THE MORE REGULATORY 704 00:21:11,542 --> 00:21:12,276 COMPLEXITY THERE IS. 705 00:21:12,276 --> 00:21:14,712 AND THEN YOU'RE IN THIS 706 00:21:14,712 --> 00:21:16,947 BALANCING ACT WHERE WHILE YOU'RE 707 00:21:16,947 --> 00:21:18,249 AWAITING THESE PERSONALIZED 708 00:21:18,249 --> 00:21:19,383 CELLS TO BE MANUFACTURED FOR THE 709 00:21:19,383 --> 00:21:21,218 PATIENT, YOU'RE TRYING TO KEEP 710 00:21:21,218 --> 00:21:22,086 THEIR DISEASE UNDER CONTROL BUT 711 00:21:22,086 --> 00:21:24,054 ALSO TRYING TO NOT GO OVERBOARD 712 00:21:24,054 --> 00:21:26,924 AND PUT THEM AT RISK FOR ALL OF 713 00:21:26,924 --> 00:21:28,092 THESE CO-MORBIDITIES WHEN THE 714 00:21:28,092 --> 00:21:30,394 CELLS ARE READY, THEY SAY, 715 00:21:30,394 --> 00:21:32,029 ACTUALLY, HE HAS AN INVASIVE 716 00:21:32,029 --> 00:21:32,897 FUNGAL INFECTION? 717 00:21:32,897 --> 00:21:34,431 THAT'S NOT GOING TO WORK. 718 00:21:34,431 --> 00:21:36,400 SO IT'S A FINE BALANCING ACT 719 00:21:36,400 --> 00:21:38,102 THAT TAKES A LOT OF 720 00:21:38,102 --> 00:21:39,069 COMMUNICATION AND VERY 721 00:21:39,069 --> 00:21:40,538 CHALLENGING FOR THE PATIENT THAT 722 00:21:40,538 --> 00:21:43,040 IS BETWEEN MULTIPLE CENTERS AND 723 00:21:43,040 --> 00:21:44,742 MULTIPLE PROVIDERS. 724 00:21:44,742 --> 00:21:46,210 AND THEN THE PLANNING. 725 00:21:46,210 --> 00:21:48,312 SO I HAVE THREE PATIENTS THAT 726 00:21:48,312 --> 00:21:49,480 ARE COMING WITHIN THE NEXT WEEK 727 00:21:49,480 --> 00:21:51,515 FROM ALL OVER THE COUNTRY AND 728 00:21:51,515 --> 00:21:53,984 THE AMOUNT OF TIME AND EFFORT 729 00:21:53,984 --> 00:21:56,921 AND NUMBER OF PEOPLE TO TRY TO 730 00:21:56,921 --> 00:21:58,222 GET EVERYTHING TOGETHER FOR A 731 00:21:58,222 --> 00:21:59,924 RELAPSE REFRACTARY PATIENT TO 732 00:21:59,924 --> 00:22:01,425 TRAVEL ACROSS THE COUNTRY, TO 733 00:22:01,425 --> 00:22:02,359 RECEIVE CELLS THAT ARE OTHERWISE 734 00:22:02,359 --> 00:22:05,262 GOING TO BE THROWN AWAY, OR USED 735 00:22:05,262 --> 00:22:06,831 FOR RESEARCH, NOT USED FOR 736 00:22:06,831 --> 00:22:08,566 ANYONE ELSE IF THEY DON'T GET 737 00:22:08,566 --> 00:22:09,567 THEM, IT'S SUBSTANTIAL. 738 00:22:09,567 --> 00:22:12,670 SO THIS IS OBVIOUSLY NOT SIMPLE. 739 00:22:12,670 --> 00:22:15,039 AND THE ISSUE IS, WHEN YOU EVEN 740 00:22:15,039 --> 00:22:16,841 DISCUSS THIS WITH PEOPLE, THEY 741 00:22:16,841 --> 00:22:18,576 OFTEN, THE ROAD WILL BE CLOSED 742 00:22:18,576 --> 00:22:19,243 UPFRONT. 743 00:22:19,243 --> 00:22:20,277 THEY ARE LIKE, I DON'T THINK MY 744 00:22:20,277 --> 00:22:21,745 PATIENT WILL BE ABLE TO DO THAT. 745 00:22:21,745 --> 00:22:23,981 AND SO I'M GOING TO GO THROUGH A 746 00:22:23,981 --> 00:22:25,249 FEW COMMON SCENARIOS. 747 00:22:25,249 --> 00:22:27,184 THESE ARE PEDE 8 RICK. 748 00:22:27,184 --> 00:22:30,855 I KNOW MOST OF YOU -- 749 00:22:30,855 --> 00:22:32,556 PEDIATRIC -- I KNOW MOST OF YOU 750 00:22:32,556 --> 00:22:34,758 STEAK CARE OF ADULTS. 751 00:22:34,758 --> 00:22:36,160 -- TAKE CARE OF ADULTS. 752 00:22:36,160 --> 00:22:38,562 YOU WILL THINK ABOUT SCENARIOS 753 00:22:38,562 --> 00:22:40,664 YOU MAY HAVE SEEN THAT MAY BE 754 00:22:40,664 --> 00:22:40,898 SIMILAR. 755 00:22:40,898 --> 00:22:42,600 THESE ARE MADE UP NAMES. 756 00:22:42,600 --> 00:22:43,267 ELI IS 9. 757 00:22:43,267 --> 00:22:45,970 HE HAS REFRACTARY TALL LIVES IN 758 00:22:45,970 --> 00:22:49,573 MISSOURI WITH MOM AND SINCE. 759 00:22:49,573 --> 00:22:52,943 ELIGIBLE FOR TRANSPLANT BUT 760 00:22:52,943 --> 00:22:55,646 RESIDUAL DISEASE AND HAS 761 00:22:55,646 --> 00:22:56,747 NUMEROUS TAPERRIES IN THE PAST 762 00:22:56,747 --> 00:22:58,515 AND REFERRING ONCOLOGIST HEARD 763 00:22:58,515 --> 00:23:01,118 ABOUT THE SUCCESS OF YOUR CD5 764 00:23:01,118 --> 00:23:02,686 CAR-T CELL TRIAL AND SAYS MAYBE 765 00:23:02,686 --> 00:23:04,288 THIS WILL BE GREAT FOR HIM BUT 766 00:23:04,288 --> 00:23:07,358 REALLY WORRIED ABOUT TRAVEL, 767 00:23:07,358 --> 00:23:08,459 INSURANCE, HE KNOWS THEY ARE OUT 768 00:23:08,459 --> 00:23:12,229 OF NETWORK AND HOW THEIR FAMILY 769 00:23:12,229 --> 00:23:13,464 WILL HANDLED BEING UPROOTED TO 770 00:23:13,464 --> 00:23:14,365 ANOTHER CITY. 771 00:23:14,365 --> 00:23:16,133 SHE MENTIONS THE TRIAL TO THE 772 00:23:16,133 --> 00:23:18,202 FAMILY BUT RECOMMENDS 773 00:23:18,202 --> 00:23:19,069 ALTERNATIVE TREATMENT. 774 00:23:19,069 --> 00:23:21,305 CONSIDERING THAT WILL BE LESS 775 00:23:21,305 --> 00:23:21,605 DISRUPTIVE. 776 00:23:21,605 --> 00:23:23,474 FOR EXAMPLE, IT IS IN HOUSTON 777 00:23:23,474 --> 00:23:24,875 TEXAS BUT ATS A LOT. 778 00:23:24,875 --> 00:23:26,477 AND I'M NOT SURE THAT YOU ALL 779 00:23:26,477 --> 00:23:27,611 ARE GOING TO BE UP FOR IT. 780 00:23:27,611 --> 00:23:29,446 SO WE ARE NOT GOING TO GO INTO 781 00:23:29,446 --> 00:23:30,881 DETAIL BUT I DO HAVE THESE ORAL 782 00:23:30,881 --> 00:23:32,483 CHEMOS THAT ARE PROBABLY GOING 783 00:23:32,483 --> 00:23:33,951 TO BE MORE PALLIATIVE. 784 00:23:33,951 --> 00:23:36,020 SO THIS IS A VERY COMMON 785 00:23:36,020 --> 00:23:41,325 SCENARIO THAT HAPPENS. 786 00:23:41,325 --> 00:23:42,593 HODGKIN LYMPHOMA GOT LOTS OF 787 00:23:42,593 --> 00:23:45,696 PAST THERAPIES AND RESIDUAL 788 00:23:45,696 --> 00:23:45,930 DISEASE. 789 00:23:45,930 --> 00:23:47,998 EL JILL FOR TRIAL BUT UNINSURED 790 00:23:47,998 --> 00:23:48,899 AND UNDOCUMENTED. 791 00:23:48,899 --> 00:23:52,002 DAD WORKS FULL-TIME, MOM IS AT 792 00:23:52,002 --> 00:23:53,504 HOME, HER MOM MENTIONED IN THE 793 00:23:53,504 --> 00:23:54,872 PAST THAT THE TREATMENT IS IN 794 00:23:54,872 --> 00:23:55,606 GOD'S HANDS. 795 00:23:55,606 --> 00:23:57,808 SO PRIMARY ONCOLOGIST DETERMINES 796 00:23:57,808 --> 00:23:59,610 THAT DESPITE THE PROMISING 797 00:23:59,610 --> 00:24:01,512 RESULTS, TOO MANY LOGISTICAL 798 00:24:01,512 --> 00:24:03,013 BARRIERS AND MENTIONS THAT I 799 00:24:03,013 --> 00:24:05,416 THINK THEY MIGHT BE HESITANT TO 800 00:24:05,416 --> 00:24:06,717 PARTICIPATE IN GENE THERAPY 801 00:24:06,717 --> 00:24:10,020 RESEARCH ANYWAY BECAUSE OF A LOT 802 00:24:10,020 --> 00:24:10,621 OF EXPERIMENTATION AND THINGS 803 00:24:10,621 --> 00:24:12,122 HAPPENED IN THE PAST. 804 00:24:12,122 --> 00:24:14,325 I KNOW THEY ARE SPIRITUAL AND 805 00:24:14,325 --> 00:24:16,493 HUT THINGS IN GOD'S HANDS SO I'M 806 00:24:16,493 --> 00:24:21,598 HESITANT TO MENTION IT TO THEM. 807 00:24:21,598 --> 00:24:23,701 DAVID HAS A TERRIBLE BRAIN 808 00:24:23,701 --> 00:24:23,901 TUMOR. 809 00:24:23,901 --> 00:24:25,636 LIMITED TREATMENT OPTIONS, 810 00:24:25,636 --> 00:24:27,304 ELIGIBLE FOR A TRIAL. 811 00:24:27,304 --> 00:24:29,640 BECAUSE OF THE CLINICAL TEAM'S 812 00:24:29,640 --> 00:24:33,477 EXPERIENCE WITH HAVING 813 00:24:33,477 --> 00:24:35,980 DIFFICULTIES RECEIVING INSURANCE 814 00:24:35,980 --> 00:24:37,481 APPROVAL FOR OTHER THERAPIES AND 815 00:24:37,481 --> 00:24:38,983 BECAUSE HE MISSED SEVERAL 816 00:24:38,983 --> 00:24:40,517 APPOINTMENTS DUE TO DAD'S WORK 817 00:24:40,517 --> 00:24:42,286 SCHEDULE AND THE STRICT CONFINES 818 00:24:42,286 --> 00:24:43,387 OF THE STUDY, THEY SAY YOU'LL 819 00:24:43,387 --> 00:24:45,022 HAVE TO COMEBA THREE DAYS A 820 00:24:45,022 --> 00:24:46,423 WEEK, FOUR DAYS A WEEK. 821 00:24:46,423 --> 00:24:48,559 THE DOCTOR E-MAILS YOU AND SAYS 822 00:24:48,559 --> 00:24:49,526 I'M NOT SURE WHETHER WE SHOULD 823 00:24:49,526 --> 00:24:50,427 MENTION THIS STUDY. 824 00:24:50,427 --> 00:24:52,896 I THINK IT WILL ADD MORE STRESS. 825 00:24:52,896 --> 00:24:54,398 IF YOU DON'T BELIEVE THAT THESE 826 00:24:54,398 --> 00:24:56,200 ARE REAL SCENARIOS, I CAN TELL 827 00:24:56,200 --> 00:24:58,235 YOU THESE ARE SCENARIOS I DEAL 828 00:24:58,235 --> 00:25:00,304 WITH EVERY SINGLE DAY. 829 00:25:00,304 --> 00:25:02,306 USUALLY BY VERY WELL MEANING 830 00:25:02,306 --> 00:25:04,141 PROVIDERS WHO HAVE A 831 00:25:04,141 --> 00:25:04,975 RELATIONSHIP WITH THE PATIENT 832 00:25:04,975 --> 00:25:06,310 AND A FAMILY, HAVE KNOWN THEM 833 00:25:06,310 --> 00:25:07,778 FOR SEVERAL YEARS. 834 00:25:07,778 --> 00:25:08,879 I'VE NEVER MET THEM, RIGHT? 835 00:25:08,879 --> 00:25:10,614 BUT THEY REACHUTE TO ME AND SAY, 836 00:25:10,614 --> 00:25:13,417 BASED ON WHAT I FEEL ABOUT THIS 837 00:25:13,417 --> 00:25:14,852 PATIENT'S FAMILY, I'M NOT SURE 838 00:25:14,852 --> 00:25:18,088 THIS IS SOMETHING WE SHOULD EVEN 839 00:25:18,088 --> 00:25:18,322 EXPLORE. 840 00:25:18,322 --> 00:25:19,757 SHOULD WE SET UP A CALL? 841 00:25:19,757 --> 00:25:21,759 I'M HAPPY TO DO A TELEVISIT AND 842 00:25:21,759 --> 00:25:23,027 REALLY JUST TALK ABOUT IT AND 843 00:25:23,027 --> 00:25:24,495 SEE IF IT IS SOMETHING THEY ARE 844 00:25:24,495 --> 00:25:24,828 INTERESTED IN. 845 00:25:24,828 --> 00:25:27,498 LET ME TALK TO THEM, I'M NOT 846 00:25:27,498 --> 00:25:27,698 SURE. 847 00:25:27,698 --> 00:25:29,500 THE POINT IS, THAT A LOT OF 848 00:25:29,500 --> 00:25:32,036 TIMES WHEN I GO TO ACADEMIC 849 00:25:32,036 --> 00:25:33,704 MEETINGS TALKING ABOUT CAR-T 850 00:25:33,704 --> 00:25:34,738 CELLS, WE ARE ALWAYS TALKING 851 00:25:34,738 --> 00:25:36,206 ABOUT HOW TO MAKE THE 852 00:25:36,206 --> 00:25:38,308 MANUFACTURE BETTER, FASTER, 853 00:25:38,308 --> 00:25:39,843 STRONGER, MAKE THE CELLS BETTER, 854 00:25:39,843 --> 00:25:41,779 BUT WE'RE OFTEN NOT TALKING 855 00:25:41,779 --> 00:25:44,415 ABOUT THE ROAD BLOCKS THAT ARE 856 00:25:44,415 --> 00:25:45,449 DISPROPORTIONATELY, ESPECIALLY 857 00:25:45,449 --> 00:25:46,850 EFFECTING CERTAIN POPULATIONS. 858 00:25:46,850 --> 00:25:48,585 IF YOU NOTICE IN THOSE 859 00:25:48,585 --> 00:25:49,853 SCENARIOS, I DID NOT MENTION 860 00:25:49,853 --> 00:25:53,490 RACE OR ETHNICITY. 861 00:25:53,490 --> 00:25:55,159 UNFORTUNATELY, A LOT OF 862 00:25:55,159 --> 00:25:56,160 UNDERREPRESENTED PATIENTS HAPPEN 863 00:25:56,160 --> 00:25:58,162 TO HAVE SOME OF THE SAME SOCIAL 864 00:25:58,162 --> 00:25:58,896 DETERMINANTS OF HEALTH AND 865 00:25:58,896 --> 00:26:01,732 ISSUES THAT ARE THERE, BUT THIS 866 00:26:01,732 --> 00:26:02,966 COULD BE ANY PATIENT. 867 00:26:02,966 --> 00:26:03,801 IT COULD BE ANY PATIENT. 868 00:26:03,801 --> 00:26:04,635 I THINK THAT IS THE MOST 869 00:26:04,635 --> 00:26:07,037 IMPORTANT THING TO THINK ABOUT. 870 00:26:07,037 --> 00:26:08,372 SO THERE ARE INSURANCE BARRIERS, 871 00:26:08,372 --> 00:26:11,375 COVERAGE DELAYS AND DENIALS. 872 00:26:11,375 --> 00:26:12,443 DENIALS CAN BE JUST -- DELAYS 873 00:26:12,443 --> 00:26:14,411 COULD BE JUST AS SIGNIFICANT AS 874 00:26:14,411 --> 00:26:14,978 DENIALS BECAUSE YOU'RE MORE 875 00:26:14,978 --> 00:26:17,648 LIKELY TO GET A PATIENT AT AN 876 00:26:17,648 --> 00:26:18,749 ADVANCED STAGE AFTER THEY HAD 877 00:26:18,749 --> 00:26:20,551 MORE TREATMENTS THAT MAY NOT 878 00:26:20,551 --> 00:26:23,821 NECESSARILY BE BENEFICIAL TO THE 879 00:26:23,821 --> 00:26:24,054 PATIENT. 880 00:26:24,054 --> 00:26:24,688 LO GEST CALL ISSUES RELATED TO 881 00:26:24,688 --> 00:26:26,023 THE STUDY REQUIREMENTS. 882 00:26:26,023 --> 00:26:28,826 THESE ARE THINGS THAT OFTEN 883 00:26:28,826 --> 00:26:30,327 DISPROPORTIONATELY AFFECT 884 00:26:30,327 --> 00:26:30,861 UNDERREPRESENTED PATIENTS, 885 00:26:30,861 --> 00:26:33,030 PATIENTS WHO ARE OF LOWER 886 00:26:33,030 --> 00:26:35,032 SOCIOECONOMIC STATUS, 887 00:26:35,032 --> 00:26:36,200 GEOGRAPHICALLY RESTRICTED. 888 00:26:36,200 --> 00:26:37,835 IF YOU LIVE IN BETHESDA, IF YOU 889 00:26:37,835 --> 00:26:40,571 LIVE IN DC, IF YOU HAVE A 890 00:26:40,571 --> 00:26:43,040 TWO-PARENT HOME, IF YOU HAVE A 891 00:26:43,040 --> 00:26:44,808 LARGE SOCIAL NETWORK, YOU MAY BE 892 00:26:44,808 --> 00:26:46,977 ABLE TO COME THREE DAYS A WEEK 893 00:26:46,977 --> 00:26:49,746 AND BRING THAT CHILD FOR 894 00:26:49,746 --> 00:26:51,849 PHARMACOKINETICS AND DYNAMICS 895 00:26:51,849 --> 00:26:52,082 TESTING. 896 00:26:52,082 --> 00:26:53,484 IF YOU DO NOT, IF YOU DON'T FIT 897 00:26:53,484 --> 00:27:01,525 ANY OF THOSE CATEGORIES, IT CAN 898 00:27:01,525 --> 00:27:02,726 BE A GAME CHANGER. 899 00:27:02,726 --> 00:27:03,861 WE WILL WRITE IN THE TRIAL, THEY 900 00:27:03,861 --> 00:27:06,063 HAVE TO COME OFF OF STUDY -- 901 00:27:06,063 --> 00:27:07,564 THIS IS REQUIRED BY THE STUDY. 902 00:27:07,564 --> 00:27:10,334 WE HAVE THE ABILITY TO BE MORE 903 00:27:10,334 --> 00:27:10,601 FLEXIBLE. 904 00:27:10,601 --> 00:27:11,735 WE HAVE THE ABILITY TO SAY YES, 905 00:27:11,735 --> 00:27:13,637 I WOULD LOVE TO GET THAT BLOOD 906 00:27:13,637 --> 00:27:14,471 THREE TIMES A WEEK. 907 00:27:14,471 --> 00:27:16,673 I CAN'T WAIT TO GET TO THE LAB 908 00:27:16,673 --> 00:27:17,441 AND RUN THAT LUMINEX. 909 00:27:17,441 --> 00:27:18,809 SEE WHAT THE CYTOKINES ARE 910 00:27:18,809 --> 00:27:19,610 DOING. 911 00:27:19,610 --> 00:27:20,878 HOWEVER, IN THE REAL WORLD, WE 912 00:27:20,878 --> 00:27:22,980 HAVE TO RECOGNIZE THAT CAN 913 00:27:22,980 --> 00:27:25,616 LITERALLY BE A LIMITATION THAT 914 00:27:25,616 --> 00:27:26,917 CAUSES SOME PATIENTS TO NOT 915 00:27:26,917 --> 00:27:29,453 RECEIVE THE THERAPY. 916 00:27:29,453 --> 00:27:32,222 AND THEN, WE - WHO DOESN'T HAVE 917 00:27:32,222 --> 00:27:33,857 UNCONSCIOUS BIAS IN HERE? 918 00:27:33,857 --> 00:27:34,958 I HAVE A LOT. 919 00:27:34,958 --> 00:27:35,659 WE ALL DO. 920 00:27:35,659 --> 00:27:37,161 AND I RECOGNIZE IT, RIGHT? 921 00:27:37,161 --> 00:27:38,896 I THINK ABOUT IT ALL THE TIME 922 00:27:38,896 --> 00:27:40,931 BECAUSE I RECOGNIZE THAT THE 923 00:27:40,931 --> 00:27:42,666 BIASES THAT CAN COME OUT IN HIGH 924 00:27:42,666 --> 00:27:44,368 STRESS SITUATIONS, AND I KNOW 925 00:27:44,368 --> 00:27:46,703 Y'ALL ARE NEVER IN HIGH STRESS 926 00:27:46,703 --> 00:27:47,671 SITUATIONS, RIGHT? 927 00:27:47,671 --> 00:27:49,273 SO, BECAUSE OF THAT, WE OFTEN 928 00:27:49,273 --> 00:27:51,108 ARE THINKING THAT WE'RE DOING 929 00:27:51,108 --> 00:27:53,110 WHAT IS IN OUR PATIENT'S BEST 930 00:27:53,110 --> 00:27:55,112 INTEREST BY REMOVING CERTAIN 931 00:27:55,112 --> 00:27:57,381 OPTIONS OR DISCUSSING CERTAIN 932 00:27:57,381 --> 00:27:58,048 OPTIONS ABOVE OTHERS BECAUSE WE 933 00:27:58,048 --> 00:27:59,449 THINK WE ARE DOING WHAT IS BEST 934 00:27:59,449 --> 00:28:00,417 FOR THEM. 935 00:28:00,417 --> 00:28:02,085 RESEARCH OVERWHELMINGLY SHOWS 936 00:28:02,085 --> 00:28:04,021 THAT PATIENTS WANT TO KNOW ABOUT 937 00:28:04,021 --> 00:28:04,988 ALL OF THE OPTIONS. 938 00:28:04,988 --> 00:28:06,590 THEY WANT TO BE INVOLVED IN THAT 939 00:28:06,590 --> 00:28:07,324 DECISION-MAKING. 940 00:28:07,324 --> 00:28:09,526 SO WE KNOW HOW TRUSTED OUR 941 00:28:09,526 --> 00:28:11,195 RELATIONSHIP IS WITH OUR 942 00:28:11,195 --> 00:28:12,596 PATIENTS AND ONCOLOGY TOW TAKE 943 00:28:12,596 --> 00:28:14,798 CARE OF THEM FOR SO LONG AND WE 944 00:28:14,798 --> 00:28:16,300 SEE THEM SO FREQUENTLY. 945 00:28:16,300 --> 00:28:18,135 SO WE HAVE TO BE REALLY ATTUNED 946 00:28:18,135 --> 00:28:19,469 TO THE FACT THAT WE MAY BE 947 00:28:19,469 --> 00:28:23,006 REMOVING OPTIONS AND MAKING THEM 948 00:28:23,006 --> 00:28:24,508 SOUND LESS PALATABLE BECAUSE OF 949 00:28:24,508 --> 00:28:26,076 A PRE CONCEPTION IT WILL BE MORE 950 00:28:26,076 --> 00:28:27,077 CHALLENGING FOR THE FAMILY. 951 00:28:27,077 --> 00:28:29,713 COMING FROM A GOOD PLACE, 952 00:28:29,713 --> 00:28:29,980 THOUGH. 953 00:28:29,980 --> 00:28:31,848 UNLIKE MEDICINES THAT ARE 954 00:28:31,848 --> 00:28:33,450 LITERALLY OFF THE SHELF, PEOPLE 955 00:28:33,450 --> 00:28:34,284 FEEL LIKE THEY HAVE TO HAVE ALL 956 00:28:34,284 --> 00:28:35,986 OF THIS STUFF FIGURED OUT BEFORE 957 00:28:35,986 --> 00:28:36,987 THEY OFFER SOMETHING TO A 958 00:28:36,987 --> 00:28:40,390 PATIENT OR A FAMILY. 959 00:28:40,390 --> 00:28:41,458 SO THERE ARE OTHER HARSH WELL 960 00:28:41,458 --> 00:28:42,726 REALITIES EVEN WHEN YOU'RE IN A 961 00:28:42,726 --> 00:28:44,661 PLACE WHERE YOU HAVE FINANCIAL 962 00:28:44,661 --> 00:28:45,495 ASSISTANCE WHERE THE TRIAL IS 963 00:28:45,495 --> 00:28:48,098 PAID FOR, HOUSING, LODGING, 964 00:28:48,098 --> 00:28:49,733 ET CETERA, WHERE JUST HAVING TO 965 00:28:49,733 --> 00:28:51,101 UPROOT TO TRAVEL TO AND REMAIN 966 00:28:51,101 --> 00:28:52,903 FOR AN EXTENDED PERIOD TO 967 00:28:52,903 --> 00:28:54,538 PARTICIPATE IN A TRIAL, IS A 968 00:28:54,538 --> 00:28:54,738 LOT. 969 00:28:54,738 --> 00:28:56,907 EVEN IF YOU SAY, BUT WE COVER 970 00:28:56,907 --> 00:28:57,140 HOUSING. 971 00:28:57,140 --> 00:28:58,308 WE'LL BE OKAY. 972 00:28:58,308 --> 00:28:59,409 WE GIVE FOOD VOUCHERS. 973 00:28:59,409 --> 00:29:03,180 IT IS REALLY A PRIVILEGE THAT 974 00:29:03,180 --> 00:29:04,915 MANY OF US CAN PROBABLY DO BUT A 975 00:29:04,915 --> 00:29:07,317 LOT OF PEOPLE JUST CANNOT DO 976 00:29:07,317 --> 00:29:07,551 THAT. 977 00:29:07,551 --> 00:29:09,653 AND THEN, WE HAVE TO LOOK AT 978 00:29:09,653 --> 00:29:10,454 REFERRAL PATTERNS. 979 00:29:10,454 --> 00:29:11,822 I STARTED DOING SOME STUDIES 980 00:29:11,822 --> 00:29:13,757 WHERE WE TALKED TO REFERRING 981 00:29:13,757 --> 00:29:15,626 DOCTORS, TALKED TO PATIENTS, 982 00:29:15,626 --> 00:29:16,660 TALKED TO DOCTORS AT CENTERS 983 00:29:16,660 --> 00:29:17,261 DOING THE TRIALS. 984 00:29:17,261 --> 00:29:18,929 AND YOU START TO SEE THESE 985 00:29:18,929 --> 00:29:20,130 REFERRING PATTERNS THAT REALLY 986 00:29:20,130 --> 00:29:21,598 DO INDICATE THAT THERE MAY BE 987 00:29:21,598 --> 00:29:22,933 SOME BIASES. 988 00:29:22,933 --> 00:29:25,602 AND ONE THING THAT WE CAN CHANGE 989 00:29:25,602 --> 00:29:28,338 AS MUCH AS WE WERE TALKING ABOUT 990 00:29:28,338 --> 00:29:31,074 EARLIER, HOW YOU HAVE A TRIAL -- 991 00:29:31,074 --> 00:29:32,809 WHY IS THIS A PART OF THE 992 00:29:32,809 --> 00:29:34,978 ELIGIBILITY CRITERIA? 993 00:29:34,978 --> 00:29:35,612 DO YOU KNOW IF IT'S ALWAYS BEEN 994 00:29:35,612 --> 00:29:37,114 LIKE THAT. 995 00:29:37,114 --> 00:29:40,450 WHY IS IT AST ABOVE THE 5 TIMES 996 00:29:40,450 --> 00:29:42,519 UPPER LIMIT -- WHY IS THIS A 997 00:29:42,519 --> 00:29:42,719 PART? 998 00:29:42,719 --> 00:29:44,221 EVERY TIME YOU HAVE TO WRITE A 999 00:29:44,221 --> 00:29:45,622 SINGLE PATIENT PROTOCOL AND TALK 1000 00:29:45,622 --> 00:29:47,424 ABOUT COMPASSIONATE USE, 1001 00:29:47,424 --> 00:29:49,793 VARIATION, YOU SHOULD THINK, IS 1002 00:29:49,793 --> 00:29:52,663 OUR TRIAL CRITERIA TOO 1003 00:29:52,663 --> 00:29:52,929 STRINGENT? 1004 00:29:52,929 --> 00:29:56,333 AND A LOT OF THESE THINGS, BMI 1005 00:29:56,333 --> 00:29:59,303 IS NOT -- IS BASED ON A EUROPEAN 1006 00:29:59,303 --> 00:30:00,304 VERSION OF BMI. 1007 00:30:00,304 --> 00:30:03,240 IF YOUD HAVE OVERLY RESTRICTIVE 1008 00:30:03,240 --> 00:30:04,841 CRITERIA BASED ON BMI, PATIENTS 1009 00:30:04,841 --> 00:30:07,110 THAT ARE HIV PROCESS POSITIVE 1010 00:30:07,110 --> 00:30:08,712 WHEN THERE IS NO CLINICAL 1011 00:30:08,712 --> 00:30:10,314 RATIONAL TO EXCLUDE THEM FROM A 1012 00:30:10,314 --> 00:30:11,615 STUDY, PEOPLE WITH DIABETES THAT 1013 00:30:11,615 --> 00:30:12,949 IS CONTROLLED, HYPERTENSION THAT 1014 00:30:12,949 --> 00:30:15,285 IS CONTROLLED, WHY FOR MANY OF 1015 00:30:15,285 --> 00:30:17,821 OUR STUDIES WOULD THOSE BE 1016 00:30:17,821 --> 00:30:18,088 EXCLUSIVE? 1017 00:30:18,088 --> 00:30:18,922 WE ALL DO IT. 1018 00:30:18,922 --> 00:30:20,857 THE NUMBER OF TIMES I LOOKED AT 1019 00:30:20,857 --> 00:30:23,126 STUDIES, I'M LIKE WHAT IS IN 1020 00:30:23,126 --> 00:30:24,127 THIS CRITERIA? 1021 00:30:24,127 --> 00:30:26,363 WE HAVE TO THINK ABOUT THAT. 1022 00:30:26,363 --> 00:30:28,365 IT'S NOT JUST GETTING ON THE 1023 00:30:28,365 --> 00:30:28,565 TRIAL. 1024 00:30:28,565 --> 00:30:31,268 IT'S STAYING ON THE TRIAL. 1025 00:30:31,268 --> 00:30:33,003 IT'S NOT JUST ABOUT ENROLLMENT, 1026 00:30:33,003 --> 00:30:34,104 IT'S RETENTION. 1027 00:30:34,104 --> 00:30:36,506 SO WE KNOW THAT IN THE 1028 00:30:36,506 --> 00:30:38,642 CAR-T-CELL THERAPY SPACE, THERE 1029 00:30:38,642 --> 00:30:40,143 ARE SIGNIFICANT SOCIOECONOMIC 1030 00:30:40,143 --> 00:30:40,944 AND RACIAL DISPARITIES. 1031 00:30:40,944 --> 00:30:42,946 THE NUMBER OF AFRICAN-AMERICAN 1032 00:30:42,946 --> 00:30:44,448 PATIENTS, DESPITE EVEN IN 1033 00:30:44,448 --> 00:30:46,149 DISEASES LIKE MULTIPLE MYELOMA, 1034 00:30:46,149 --> 00:30:48,085 WHERE AFRICAN-AMERICANS AND 1035 00:30:48,085 --> 00:30:50,253 BLACKS ARE OVERREPRESENTED, THE 1036 00:30:50,253 --> 00:30:52,255 NUMBER OF PATIENTS ENROLLED ON 1037 00:30:52,255 --> 00:30:54,858 THESE TRIALS, 71% IS WHITE 1038 00:30:54,858 --> 00:30:55,125 PATIENTS. 1039 00:30:55,125 --> 00:30:56,259 THESE ARE PIVOTAL TRIALS THAT 1040 00:30:56,259 --> 00:30:59,329 LED TO FDA APPROVAL. 1041 00:30:59,329 --> 00:31:01,665 AND IT DISEASE LIKE MULTIPLE 1042 00:31:01,665 --> 00:31:01,898 MYELOMA. 1043 00:31:01,898 --> 00:31:03,567 THAT TELLS US IF WE ARE DOING A 1044 00:31:03,567 --> 00:31:05,702 THERAPY WE BELIEVE IS BASED 1045 00:31:05,702 --> 00:31:06,737 SCIENTIFICALLY, IT SHOULD WORK 1046 00:31:06,737 --> 00:31:09,473 BASED ON EXPRESSION OF A MARKER, 1047 00:31:09,473 --> 00:31:10,607 NOT ON ANYTHING ELSE. 1048 00:31:10,607 --> 00:31:12,476 AND THIS DISEASE IS OVER RENTED 1049 00:31:12,476 --> 00:31:14,344 IN A PATIENT POPULATION AND YET, 1050 00:31:14,344 --> 00:31:17,080 YOU ONLY HAVE 5.6% OF THE 1051 00:31:17,080 --> 00:31:18,582 PATIENT POPULATION THAT IS THAT. 1052 00:31:18,582 --> 00:31:20,684 THEN THAT IS AN ISSUE, RIGHT? 1053 00:31:20,684 --> 00:31:22,152 AND YOU SHOULDN'T RECOGNIZE THAT 1054 00:31:22,152 --> 00:31:25,188 AT THE VERY END BUT WE ALL DO 1055 00:31:25,188 --> 00:31:25,389 IT. 1056 00:31:25,389 --> 00:31:27,457 SAME THING ON CAR-T CELL TRIALS 1057 00:31:27,457 --> 00:31:28,525 AND LYMPHOMA. 1058 00:31:28,525 --> 00:31:31,194 SAME PATTERNS THAT WE SEE. 1059 00:31:31,194 --> 00:31:32,562 AND OVERWHELMINGLY IF YOU TALK 1060 00:31:32,562 --> 00:31:35,098 TO DISPARITIES RESEARCHERS, THEY 1061 00:31:35,098 --> 00:31:36,600 WILL SAY, ACCESS NOT WILLINGNESS 1062 00:31:36,600 --> 00:31:38,201 IS WHERE THE DIFFICULTY LIES IN 1063 00:31:38,201 --> 00:31:39,936 RECRUITING AND MAINTAINING 1064 00:31:39,936 --> 00:31:41,671 MINORITY RESEARCH PARTICIPANTS. 1065 00:31:41,671 --> 00:31:44,441 IT'S NOT THAT BECAUSE OF 1066 00:31:44,441 --> 00:31:45,108 HISTORICAL MISTRUST, IT'S 1067 00:31:45,108 --> 00:31:47,444 IMPOSSIBLE TO ENROLL SOMEONE. 1068 00:31:47,444 --> 00:31:48,845 MANY PATIENTS WILL SAY, IF YOU 1069 00:31:48,845 --> 00:31:50,881 LOOK AT SURVEYS OF PATIENTS, 1070 00:31:50,881 --> 00:31:51,615 THERE ARE SO MANY PUBLISHED 1071 00:31:51,615 --> 00:31:53,216 WHERE THEY SAY I WASN'T AWARE 1072 00:31:53,216 --> 00:31:55,852 THAT WAS AN OPTION FOR ME. 1073 00:31:55,852 --> 00:31:57,721 IF YOU SPENT AN HOUR TALKING 1074 00:31:57,721 --> 00:31:59,222 ABOUT AN OPTION AND YOU LEFT THE 1075 00:31:59,222 --> 00:32:01,758 ROOM AND THEN SOMEONE CAME BACK, 1076 00:32:01,758 --> 00:32:02,492 WHOEVER HAD THIS? 1077 00:32:02,492 --> 00:32:04,261 THE PATIENT SAID YOU DIDN'T 1078 00:32:04,261 --> 00:32:05,929 MENTION AND YOU'RE LIKE, WHAT? 1079 00:32:05,929 --> 00:32:08,498 I SAID -- LIKE IT HAPPENS TO ALL 1080 00:32:08,498 --> 00:32:09,065 OF US, RIGHT? 1081 00:32:09,065 --> 00:32:11,201 I THINK THAT WE HAVE TO REFRAME 1082 00:32:11,201 --> 00:32:13,069 IT IN THAT YES, WE MAY HAVE 1083 00:32:13,069 --> 00:32:14,604 MENTIONED THE OPTION. 1084 00:32:14,604 --> 00:32:16,306 YES WE MAY HAVE DISCUSSED IT THE 1085 00:32:16,306 --> 00:32:17,541 WAY WE WOULD LIKE TO HEAR IT. 1086 00:32:17,541 --> 00:32:19,176 PERHAPS THE WAY THAT WE 1087 00:32:19,176 --> 00:32:21,445 DISCUSSED IT WAS NOT IN A WAY 1088 00:32:21,445 --> 00:32:23,013 THAT THE PATIENT FELT LIKE IT 1089 00:32:23,013 --> 00:32:24,748 WAS TRULY A VIABLE OPTION FOR 1090 00:32:24,748 --> 00:32:24,948 THEM. 1091 00:32:24,948 --> 00:32:28,118 AND THERE IS WORK WE CAN 1092 00:32:28,118 --> 00:32:28,385 DO - THAT. 1093 00:32:28,385 --> 00:32:31,555 SO I BECAME VERY DEDICATED TO 1094 00:32:31,555 --> 00:32:33,323 EXPANDING ACCESS OF CLINICAL 1095 00:32:33,323 --> 00:32:34,191 TRIALS TO NOVEL AGENTS BECAUSE 1096 00:32:34,191 --> 00:32:36,359 THERE IS A LOT OF EVIDENCE IN 1097 00:32:36,359 --> 00:32:37,694 NON CANCER. 1098 00:32:37,694 --> 00:32:39,930 A LOT OF EVIDENCE IN CANCER, 1099 00:32:39,930 --> 00:32:41,531 LESS EVIDENCE IN EARLY PHASE 1100 00:32:41,531 --> 00:32:41,765 TRIALS. 1101 00:32:41,765 --> 00:32:44,301 AND WHAT IS CLEAR IS YOU HAVE TO 1102 00:32:44,301 --> 00:32:46,136 CONSIDER THE BARRIERS UPFRONT 1103 00:32:46,136 --> 00:32:47,003 AND THE THROUGHOUT AND CONSIDER 1104 00:32:47,003 --> 00:32:49,406 THEM AT THE END. 1105 00:32:49,406 --> 00:32:51,107 AND ACCESSIBILITY IS A BIG THING 1106 00:32:51,107 --> 00:32:53,643 THAT WE CAN ACTUALLY HELP WITH. 1107 00:32:53,643 --> 00:32:56,112 WHEN YOU THINK ABOUT ELIGIBILITY 1108 00:32:56,112 --> 00:32:57,380 CRITERIA, LACK OF KNOWLEDGE, THE 1109 00:32:57,380 --> 00:33:00,684 WAY YOUR CONSENT FORM IS 1110 00:33:00,684 --> 00:33:01,251 WRITTEN, STUDY LOGISTICS AND 1111 00:33:01,251 --> 00:33:02,519 THEN ADDRESS THINGS LIKE LACK OF 1112 00:33:02,519 --> 00:33:03,987 TRUST AND DIFFERENT ATTITUDES 1113 00:33:03,987 --> 00:33:04,955 AND BELIEFS THAT SOMETIMES MAY 1114 00:33:04,955 --> 00:33:06,456 BE CULTURALLY BASED. 1115 00:33:06,456 --> 00:33:08,325 BUT, WE HAVE TO ASSESS THEM 1116 00:33:08,325 --> 00:33:10,927 EARLY AND WE HAVE TO ASSESS THEM 1117 00:33:10,927 --> 00:33:12,262 FREQUENTLY AND INVOLVE OTHER 1118 00:33:12,262 --> 00:33:12,496 PEOPLE. 1119 00:33:12,496 --> 00:33:15,265 WHO IS A SOCIAL WORKER MONDAY, 1120 00:33:15,265 --> 00:33:16,266 WEDNESDAY, FRIDAYS? 1121 00:33:16,266 --> 00:33:17,434 I AM. 1122 00:33:17,434 --> 00:33:19,169 I'M A FINANCIAL COUNSELOR ON 1123 00:33:19,169 --> 00:33:20,637 TUESDAY, A PSYCHIATRIST ON 1124 00:33:20,637 --> 00:33:20,904 THURSDAY. 1125 00:33:20,904 --> 00:33:22,138 HOWEVER, IF I'M TRYING TO DO ALL 1126 00:33:22,138 --> 00:33:23,740 OF THOSE JOBS, I'M NOT ENGAGING 1127 00:33:23,740 --> 00:33:25,008 THE PEOPLE WHO LITERALLY THAT IS 1128 00:33:25,008 --> 00:33:26,109 THEIR EXPERTISE. 1129 00:33:26,109 --> 00:33:27,911 SO ONE THING WE HAVE TO REALIZE 1130 00:33:27,911 --> 00:33:30,113 IS THAT WE MAY NOT KNOW ABOUT A 1131 00:33:30,113 --> 00:33:31,181 RESOURCE BUT THERE IS SOMEONE 1132 00:33:31,181 --> 00:33:32,716 WHO KNOWS ABOUT IT AND WE HAVE 1133 00:33:32,716 --> 00:33:34,751 TO BRING THOSE PEOPLE IN EARLY 1134 00:33:34,751 --> 00:33:36,686 WHEN WE'RE DESIGNING TRIALS. 1135 00:33:36,686 --> 00:33:39,155 SO AS I WAS THINKING ABOUT THIS, 1136 00:33:39,155 --> 00:33:40,123 I DREW THESE DIFFERENT. 1137 00:33:40,123 --> 00:33:42,259 I MADE THE TABLE A LITTLE MORE 1138 00:33:42,259 --> 00:33:43,460 DIVERSE BECAUSE I FOUND THIS 1139 00:33:43,460 --> 00:33:47,264 PICTURE AND EDITED IT AND IT WAS 1140 00:33:47,264 --> 00:33:49,533 PRETTY AND I EDIT MYSELF IN 1141 00:33:49,533 --> 00:33:49,799 THERE. 1142 00:33:49,799 --> 00:33:51,568 SO AS I WAS THINKING ABOUT THESE 1143 00:33:51,568 --> 00:33:53,570 THINGS, I HAVE AMAZING 1144 00:33:53,570 --> 00:33:54,471 MENTORSHIP AND I WAS ENCOURAGED 1145 00:33:54,471 --> 00:33:56,239 TO STAY IN MY LANE AND PEOPLE 1146 00:33:56,239 --> 00:33:58,341 WOULD SAY, IT WILL BE 1147 00:33:58,341 --> 00:33:59,276 CHALLENGING FOR YOU BECAUSE 1148 00:33:59,276 --> 00:34:00,977 YOU'RE NOT A HEALTH EQUITY 1149 00:34:00,977 --> 00:34:01,278 RESEARCHER. 1150 00:34:01,278 --> 00:34:02,145 YOU'RE NOT GOING TO BE ABLE DO 1151 00:34:02,145 --> 00:34:02,812 DO THIS. 1152 00:34:02,812 --> 00:34:05,148 OR, AND WE HEAR THIS A LAYOUT. 1153 00:34:05,148 --> 00:34:07,117 IT'S REALLY CHALLENGING TO TAKE 1154 00:34:07,117 --> 00:34:08,652 RACE AND ETHNICITY INTO ACCOUNT 1155 00:34:08,652 --> 00:34:10,053 IF YOU'RE IN A PHASE I TRIAL 1156 00:34:10,053 --> 00:34:12,789 WHERE YOU'RE ONLY ENROLLING 23 1157 00:34:12,789 --> 00:34:13,056 PATIENTS. 1158 00:34:13,056 --> 00:34:15,258 ALL OF US GET CONCERNED LIKE WE 1159 00:34:15,258 --> 00:34:16,693 WANT TO EXPAND DIVERSITY BUT WE 1160 00:34:16,693 --> 00:34:17,928 THINK ABOUT PATIENT POPULATIONS 1161 00:34:17,928 --> 00:34:19,863 AND WE'RE LIKE, HOW ARE WE GOING 1162 00:34:19,863 --> 00:34:21,865 TO GUARANTEE THAT ON A VERY 1163 00:34:21,865 --> 00:34:22,499 SMALL TRIAL? 1164 00:34:22,499 --> 00:34:23,800 OR YOU'LL HAVE TO CHOOSE WHETHER 1165 00:34:23,800 --> 00:34:25,769 YOU FOCUS ON THE SCIENCE OR YOU 1166 00:34:25,769 --> 00:34:26,836 FOCUS ON THE DISPARITIES. 1167 00:34:26,836 --> 00:34:27,971 YOU'RE NOT GOING TO BE ABLE DO 1168 00:34:27,971 --> 00:34:29,506 DO BOTH AND WE NEED BIGGER 1169 00:34:29,506 --> 00:34:31,374 CHANGE AND THERE HAS TO BE 1170 00:34:31,374 --> 00:34:32,609 POLICY CHANGE AND SCIENTISTS 1171 00:34:32,609 --> 00:34:33,376 CAN'T DO THIS. 1172 00:34:33,376 --> 00:34:34,878 I'M LIKE THIS IS MY LANE. 1173 00:34:34,878 --> 00:34:36,680 I WEAR ALL THESE HATS AND LEAD 1174 00:34:36,680 --> 00:34:38,148 ALL THESE DEI INITIATIVES AND 1175 00:34:38,148 --> 00:34:39,616 I'M A CLINICAL RESEARCHER AND I 1176 00:34:39,616 --> 00:34:41,384 HAVE BEEN IN THE LAB AND I'M A 1177 00:34:41,384 --> 00:34:42,018 TRANSLATIONAL RESEARCHER AND I 1178 00:34:42,018 --> 00:34:44,187 DO ALL OF THESE THINGS. 1179 00:34:44,187 --> 00:34:45,221 SO WHY WOULD I NOT? 1180 00:34:45,221 --> 00:34:46,423 IF I'M IDENTIFYING A PROBLEM 1181 00:34:46,423 --> 00:34:48,325 WITH MY CLINICAL TRIAL, WHY 1182 00:34:48,325 --> 00:34:50,093 WOULD I NOT BE ABLE TO IMPACT 1183 00:34:50,093 --> 00:34:51,728 SOME OF THESE THINGS? 1184 00:34:51,728 --> 00:34:53,496 AND SO, I SAY THIS ALL THE TIME. 1185 00:34:53,496 --> 00:34:55,332 IF WE CAN BUILD IT, WE CAN 1186 00:34:55,332 --> 00:34:56,533 ADVOCATE FOR ACCESS. 1187 00:34:56,533 --> 00:34:58,902 I CANNOT TELL Y'ALL THESE 1188 00:34:58,902 --> 00:34:59,836 SCIENCES -- THE NUMBER OF THINGS 1189 00:34:59,836 --> 00:35:03,039 THEY CAN PUT IN A T-CELL. 1190 00:35:03,039 --> 00:35:04,874 I'M LIKE, IS THIS THE FUTURE? 1191 00:35:04,874 --> 00:35:08,278 LIKE LITERALLY YOU CAN ALMOST DO 1192 00:35:08,278 --> 00:35:09,412 ANYTHING BUT IF YOU CAN'T GET 1193 00:35:09,412 --> 00:35:10,513 THAT TO THE PATIENT IT'S A 1194 00:35:10,513 --> 00:35:11,414 PROBLEM AND YOU HAVE TO THINK 1195 00:35:11,414 --> 00:35:12,115 ABOUT IT THROUGHOUT. 1196 00:35:12,115 --> 00:35:13,316 IT REALLY IS EVERYONE'S LANE 1197 00:35:13,316 --> 00:35:15,118 BECAUSE WE ALL PLAY A ROLE. 1198 00:35:15,118 --> 00:35:17,854 SO, I STARTED BY ESTABLISHING 1199 00:35:17,854 --> 00:35:18,822 THIS WILL DIVERSITY COUNCIL 1200 00:35:18,822 --> 00:35:22,392 WITHIN OUR COMPREHENSIVE CANCER 1201 00:35:22,392 --> 00:35:22,626 CENTER. 1202 00:35:22,626 --> 00:35:24,027 ACTIVITY BENCH SCIENTISTS, 1203 00:35:24,027 --> 00:35:26,363 TRAINEES, PATIENTS, ADVOCATES, 1204 00:35:26,363 --> 00:35:27,063 RESEARCH COORDINATORS, COMMUNITY 1205 00:35:27,063 --> 00:35:29,099 MEMBERS, AND THEN I REALIZED 1206 00:35:29,099 --> 00:35:31,267 THAT MOST PATIENT ADVOCACY 1207 00:35:31,267 --> 00:35:32,769 GROUPS AND PATIENT ADVOCACY 1208 00:35:32,769 --> 00:35:35,038 BOARDS ARE MADE UP OF PEOPLE WHO 1209 00:35:35,038 --> 00:35:38,642 ARE OFTEN HAVE THE ABILITY TO GO 1210 00:35:38,642 --> 00:35:40,543 AROUND ADVOCATING AND THAT IS 1211 00:35:40,543 --> 00:35:43,847 OFTEN UPPER MIDDLE-CLASS, HIGH 1212 00:35:43,847 --> 00:35:47,050 HEALTH LITERACY, NOT NECESSARILY 1213 00:35:47,050 --> 00:35:48,385 REFLECTIVE OF THE PATIENT 1214 00:35:48,385 --> 00:35:49,252 POPULATION I SERVE. 1215 00:35:49,252 --> 00:35:51,054 SO WE HAVE A VERY DIVERSE BOARD 1216 00:35:51,054 --> 00:35:52,722 AND I WANTED TO HAVE A CANCER 1217 00:35:52,722 --> 00:35:55,125 CELL THERAPY SPECIFIC PATIENT 1218 00:35:55,125 --> 00:35:56,126 AND CAREGIVER ADVISORY BOARD WHO 1219 00:35:56,126 --> 00:35:57,460 HAD BEEN ON OUR TRIALS AND 1220 00:35:57,460 --> 00:35:58,261 STRUGGLED WITH THINGS TO REALLY 1221 00:35:58,261 --> 00:36:00,463 BE ABLE TO LOOK AT OUR TRIALS 1222 00:36:00,463 --> 00:36:00,797 FROM UPFRONT. 1223 00:36:00,797 --> 00:36:02,465 LOOK AT WHAT MAY BE AN ISSUE. 1224 00:36:02,465 --> 00:36:03,767 HAVE A TRUE VOICE AND THEN TALK 1225 00:36:03,767 --> 00:36:05,268 ABOUT WHAT IS IMPORTANT TO THE 1226 00:36:05,268 --> 00:36:07,937 COMMUNITY AND REVIEW ALL OF OUR 1227 00:36:07,937 --> 00:36:08,405 RESOURCES. 1228 00:36:08,405 --> 00:36:09,739 AND ONE THING THAT IS CLEAR, IS 1229 00:36:09,739 --> 00:36:11,641 YOU HAVE TO UNDERSTAND THE 1230 00:36:11,641 --> 00:36:13,510 STATUS QUO BEFORE YOU CAN 1231 00:36:13,510 --> 00:36:14,444 IMPROVE. 1232 00:36:14,444 --> 00:36:16,579 AND SO, I WANTED TO LOOK AT THE 1233 00:36:16,579 --> 00:36:18,014 RACE AND ETHNICITY OF PATIENTS 1234 00:36:18,014 --> 00:36:20,150 WHO WERE GETTING COMMERCIAL FDA 1235 00:36:20,150 --> 00:36:21,651 APPROVED CAR-T CELLS WHO WERE 1236 00:36:21,651 --> 00:36:24,788 ENROLLING ON OUR IEC, 1237 00:36:24,788 --> 00:36:26,089 IMMUNOEFFECTIVE CELL TRIALS AND 1238 00:36:26,089 --> 00:36:27,357 LOOKING AT THE CANCER CASES IN 1239 00:36:27,357 --> 00:36:28,558 OUR DEMOGRAPHIC AREA AND SEE 1240 00:36:28,558 --> 00:36:29,859 WHERE WE WOO CAN IMPROVE. 1241 00:36:29,859 --> 00:36:31,761 WE HAVE LOTS OF HISPANIC AND 1242 00:36:31,761 --> 00:36:33,496 LATINO PATIENTS IN OUR AREA, 1243 00:36:33,496 --> 00:36:35,465 ESPECIALLY IN PEDIATRICS. 1244 00:36:35,465 --> 00:36:38,301 AND WE HAVE A GOOD NUMBER OF 1245 00:36:38,301 --> 00:36:39,269 AFRICAN-AMERICANS AND BLACKS. 1246 00:36:39,269 --> 00:36:41,037 WHILE WE MAY BE DOING WELL IN 1247 00:36:41,037 --> 00:36:42,505 SOME AREAS, I LOOK AT WHERE WE 1248 00:36:42,505 --> 00:36:44,174 HAVE TO IMPROVE AND TALK TO THE 1249 00:36:44,174 --> 00:36:45,241 PATIENTS AND CAREGIVERS TO SEE 1250 00:36:45,241 --> 00:36:46,676 HOW WE CAN DO THAT. 1251 00:36:46,676 --> 00:36:48,545 AND SO WORKING WITH OUR 1252 00:36:48,545 --> 00:36:50,013 COMMUNITY AND PATIENT CAREGIVER 1253 00:36:50,013 --> 00:36:51,481 ADVISORY BOARD AND OUR TASK 1254 00:36:51,481 --> 00:36:52,882 FORCE, WE IDENTIFIED THESE 1255 00:36:52,882 --> 00:36:53,116 DOMAINS. 1256 00:36:53,116 --> 00:36:56,052 NONE OF THESE ARE GOING TO SEEM 1257 00:36:56,052 --> 00:36:57,220 LIKE THIS TO YOU. 1258 00:36:57,220 --> 00:36:58,088 YOU SEEN THEM BEFORE. 1259 00:36:58,088 --> 00:36:59,422 THAT TELLS US THAT WE ARE SEEING 1260 00:36:59,422 --> 00:37:00,757 THE SAME PATTERNS OVER AND OVER. 1261 00:37:00,757 --> 00:37:02,225 SO WHEN YOU'RE THINKING ABOUT 1262 00:37:02,225 --> 00:37:03,660 ENHANCING ACCESS, YOU'RE 1263 00:37:03,660 --> 00:37:05,795 THINKING ABOUT RECRUITMENT, 1264 00:37:05,795 --> 00:37:06,596 RECRUEL AND RETENTION. 1265 00:37:06,596 --> 00:37:09,065 THE NUMBER AND FREQUENCY OF 1266 00:37:09,065 --> 00:37:09,299 VISITS. 1267 00:37:09,299 --> 00:37:09,899 THE UNBELIEVABLE OF PEOPLE WHO 1268 00:37:09,899 --> 00:37:10,900 SAY IF I HAVE TO COME TWICE A 1269 00:37:10,900 --> 00:37:11,601 WEEK, IT'S A NO. 1270 00:37:11,601 --> 00:37:13,803 IF I HAVE TO COME 3 TIMES A 1271 00:37:13,803 --> 00:37:15,004 WEEK, I STILL HAVE TO WORK AND 1272 00:37:15,004 --> 00:37:16,606 STILL HAVE TO DO THIS AND THAT. 1273 00:37:16,606 --> 00:37:18,208 IF YOU KNEW THAT WAS GOING TO BE 1274 00:37:18,208 --> 00:37:20,376 THE DECIDING FACTOR IN WHETHER 1275 00:37:20,376 --> 00:37:21,511 SOMEONE ENROLLED ON YOUR TRIAL, 1276 00:37:21,511 --> 00:37:24,180 I WOULD PROBABLY SAY, WE WILL 1277 00:37:24,180 --> 00:37:25,849 MAKE THE SECOND VISIT OPTIONAL 1278 00:37:25,849 --> 00:37:27,050 AND MAYBE 60% OF THE PATIENTS 1279 00:37:27,050 --> 00:37:28,885 WILL COME ON THAT VISIT. 1280 00:37:28,885 --> 00:37:30,286 IF IT'S JUST FOR LABS. 1281 00:37:30,286 --> 00:37:31,721 OBVIOUSLY FOR SAFETY, WE HAVE TO 1282 00:37:31,721 --> 00:37:32,589 BE SAFE. 1283 00:37:32,589 --> 00:37:36,359 BUT ALSO LOOKING AT WHETHER YOU 1284 00:37:36,359 --> 00:37:38,394 ALLOW LOCAL VISITS CLOSER TO 1285 00:37:38,394 --> 00:37:40,063 HOME FOR CERTAIN THINGS. 1286 00:37:40,063 --> 00:37:42,832 WHETHER YOU ARE TRACKING YOUR 1287 00:37:42,832 --> 00:37:44,033 RURAL BY RACE, ETHNICITY, BY 1288 00:37:44,033 --> 00:37:45,401 PEOPLE OUTSIDE OF YOUR IMMEDIATE 1289 00:37:45,401 --> 00:37:47,237 AREA, BY PEOPLE FROM DIFFERENT 1290 00:37:47,237 --> 00:37:47,937 GEOGRAPHIC REGIONS. 1291 00:37:47,937 --> 00:37:51,274 FOR YOU ALL, THE NIH, BY PEOPLE 1292 00:37:51,274 --> 00:37:52,542 WHO HAVE PRIVATE VERSUS PUBLIC 1293 00:37:52,542 --> 00:37:53,910 HEALTH INSURANCE, EVEN THOUGH IT 1294 00:37:53,910 --> 00:37:55,645 MAY NOT BE A FACTOR HERE BECAUSE 1295 00:37:55,645 --> 00:37:57,981 IT LEADS YOU TO OTHER CLUES 1296 00:37:57,981 --> 00:37:59,215 ABOUT OTHER ASPECTS. 1297 00:37:59,215 --> 00:38:01,084 LOOKING AT FINANCIAL BURDEN, WE 1298 00:38:01,084 --> 00:38:02,986 ALL KNOW IF WE EVER BEEN TO ANY 1299 00:38:02,986 --> 00:38:04,387 MEDICAL CENTER IN THE WORLD AND 1300 00:38:04,387 --> 00:38:06,790 WE DO NOT WORK AT AND WE HAD TO 1301 00:38:06,790 --> 00:38:08,558 PAY, THAT WOULD SET US BACK. 1302 00:38:08,558 --> 00:38:10,493 THAT 14 DOLLARS FOR THAT 3 HOURS 1303 00:38:10,493 --> 00:38:12,462 SET US BACK. 1304 00:38:12,462 --> 00:38:13,730 INCLUSION AND EXCLUSION 1305 00:38:13,730 --> 00:38:14,130 CRITERIA. 1306 00:38:14,130 --> 00:38:16,800 WE CAN CONTROL MAKING THE 1307 00:38:16,800 --> 00:38:19,636 BROADEST POSSIBLE INCLUSION 1308 00:38:19,636 --> 00:38:20,470 CRITERIA THAT IS SCIENTIFICALLY 1309 00:38:20,470 --> 00:38:21,805 AND CLINICALLY SOUND. 1310 00:38:21,805 --> 00:38:23,373 AND REALLY STANDING UP AND 1311 00:38:23,373 --> 00:38:24,307 SAYING, IS THERE A REASON THAT 1312 00:38:24,307 --> 00:38:27,010 WE HAVE REALLY USED THIS SAME 1313 00:38:27,010 --> 00:38:28,511 CRITERIA FOR YEARS AND YEARS? 1314 00:38:28,511 --> 00:38:30,780 AND THEN CULTURAL AND LINGUISTIC 1315 00:38:30,780 --> 00:38:31,781 COMPETENCE. 1316 00:38:31,781 --> 00:38:32,816 TAILORING RECRUITMENT MATERIALS 1317 00:38:32,816 --> 00:38:33,850 FOR DIFFERENT POPULATIONS. 1318 00:38:33,850 --> 00:38:36,286 WE WORK WITH OUR PATIENT 1319 00:38:36,286 --> 00:38:38,188 ADVOCATES AND WHO WANTS TO READ 1320 00:38:38,188 --> 00:38:40,790 A 16 PAGE CONSENT FORM? 1321 00:38:40,790 --> 00:38:41,991 NOBODY AT ALL. 1322 00:38:41,991 --> 00:38:42,192 OKAY? 1323 00:38:42,192 --> 00:38:43,193 NOT EVEN US. 1324 00:38:43,193 --> 00:38:45,495 AND SO BEING ABLE TO HAVE A 1325 00:38:45,495 --> 00:38:46,095 SIMPLIFIED VERSION. 1326 00:38:46,095 --> 00:38:47,831 YOU STILL HAVE YOUR REGULAR 1327 00:38:47,831 --> 00:38:49,732 INFORMED CONSENT THAT HAS THE 1328 00:38:49,732 --> 00:38:51,501 BOILERPLATE IRB LANGUAGE BUT YOU 1329 00:38:51,501 --> 00:38:52,502 ALSO HAVE ADDITIONAL. 1330 00:38:52,502 --> 00:38:55,238 AND WE CREATED THIS GUIDANCE FOR 1331 00:38:55,238 --> 00:38:56,940 ASSESSING BARRIERS TO ACCESS, 1332 00:38:56,940 --> 00:38:57,907 ENROLLMENT AND RETENTION IN 1333 00:38:57,907 --> 00:38:59,576 SPECIAL POPULATIONS AND WE DID 1334 00:38:59,576 --> 00:39:01,110 THIS AND GO AROUND TO DIFFERENT 1335 00:39:01,110 --> 00:39:02,612 DIVISIONS WITHIN OUR CANCER 1336 00:39:02,612 --> 00:39:04,447 CENTER AND IT WAS ALSO RECENTLY 1337 00:39:04,447 --> 00:39:05,849 ADOPTED BY THE BONE MARROW 1338 00:39:05,849 --> 00:39:07,417 TRANSPLANT AND CLINICAL TRIALS 1339 00:39:07,417 --> 00:39:08,518 NETWORK, A NATIONAL NETWORK. 1340 00:39:08,518 --> 00:39:09,619 SO WE WILL BE DOING THIS FOR 1341 00:39:09,619 --> 00:39:12,488 THEM AND BY CHILDREN'S ONCOLOGY 1342 00:39:12,488 --> 00:39:13,723 GROUP. 1343 00:39:13,723 --> 00:39:17,260 IT ALLOWS PEOPLE FROM STUDY 1344 00:39:17,260 --> 00:39:19,195 CONCEPTUALIZATION OR IF A 1345 00:39:19,195 --> 00:39:19,863 SPONSORED PROTOCOL IS COMING TO 1346 00:39:19,863 --> 00:39:21,164 YOU TO HAVE THIS LIST OF THINGS 1347 00:39:21,164 --> 00:39:23,099 THAT YOU'RE JUST LOOKING, YOU'RE 1348 00:39:23,099 --> 00:39:23,366 ASSESSING. 1349 00:39:23,366 --> 00:39:24,367 WILL THIS BE A PROBLEM? 1350 00:39:24,367 --> 00:39:27,070 DO WE HAVE A WAY TO FIX THIS? 1351 00:39:27,070 --> 00:39:28,938 SHOULD WE INVOLVE SOCIAL WORK 1352 00:39:28,938 --> 00:39:29,138 EARLY? 1353 00:39:29,138 --> 00:39:30,306 SHOULD WE ASK FOR THIS? 1354 00:39:30,306 --> 00:39:32,942 DO WE NEED SPECIFIC EFFORTS FOR 1355 00:39:32,942 --> 00:39:33,243 A NAVIGATOR? 1356 00:39:33,243 --> 00:39:35,078 AND IT'S NOT MEANT TO BE 1357 00:39:35,078 --> 00:39:36,079 PUNITIVE AND IT'S BEEN VERY 1358 00:39:36,079 --> 00:39:36,312 HELPFUL. 1359 00:39:36,312 --> 00:39:38,214 AND THEN JUST A FEW MORE 1360 00:39:38,214 --> 00:39:39,415 ADDITIONAL CONSIDERATIONS ON 1361 00:39:39,415 --> 00:39:39,849 STUDY DESIGN. 1362 00:39:39,849 --> 00:39:42,051 IT IS REALLY IMPORTANT TO LOOK 1363 00:39:42,051 --> 00:39:43,920 AT SCREENING AND ENROLLMENT 1364 00:39:43,920 --> 00:39:45,955 FAILURES AND WHETHER IT'S A TRUE 1365 00:39:45,955 --> 00:39:47,824 CLINICAL REASON SOMEONE DID NOT 1366 00:39:47,824 --> 00:39:50,560 MEET THE ELIGIBILITY CRITERIA, 1367 00:39:50,560 --> 00:39:51,361 INVESTIGATOR DISCRETION, WHETHER 1368 00:39:51,361 --> 00:39:52,161 THE PATIENT DID NOT PROVIDE A 1369 00:39:52,161 --> 00:39:52,395 REASON. 1370 00:39:52,395 --> 00:39:55,431 BECAUSE IT CAN GIVE YOU SOME 1371 00:39:55,431 --> 00:39:55,632 CLUES. 1372 00:39:55,632 --> 00:39:56,833 AND THEN REASONS FOR COMING OFF 1373 00:39:56,833 --> 00:39:59,135 TREATMENT OR STUDY BECAUSE THE 1374 00:39:59,135 --> 00:40:00,970 PERCEPTION IS A LOT OF THESE ARE 1375 00:40:00,970 --> 00:40:01,237 CLINICAL. 1376 00:40:01,237 --> 00:40:02,639 THE REALITY IS THAT MOST OF 1377 00:40:02,639 --> 00:40:04,207 THESE ARE NOT CLINICAL. 1378 00:40:04,207 --> 00:40:05,441 SO THAT HELPS YOU SEE WHY DID 1379 00:40:05,441 --> 00:40:06,609 YOU COME OFF STUDY? 1380 00:40:06,609 --> 00:40:07,844 WELL, IT JUST GOT REALLY HARD 1381 00:40:07,844 --> 00:40:08,645 FOR ME. 1382 00:40:08,645 --> 00:40:10,446 SO SOMEONE COMING OFF STUDY WHEN 1383 00:40:10,446 --> 00:40:11,547 THEY HAVE BEEN ON THE STUDY FOR 1384 00:40:11,547 --> 00:40:13,249 TWO MONTHS OF A DRUG THEY ARE 1385 00:40:13,249 --> 00:40:16,753 GOING TO GET FOR THREE MONTHS, 1386 00:40:16,753 --> 00:40:18,655 IS SUBSTANTIAL. 1387 00:40:18,655 --> 00:40:19,889 BECAUSE YOU WERE ABLE TO ENROLL 1388 00:40:19,889 --> 00:40:22,125 THEM BUT NOT NECESSARILY TO 1389 00:40:22,125 --> 00:40:23,826 RETAIN THEM. 1390 00:40:23,826 --> 00:40:25,929 WHAT IS KNOWN OF THE BIOLOGICAL 1391 00:40:25,929 --> 00:40:26,596 IMPORTANCE OF RACE OR GENDER TO 1392 00:40:26,596 --> 00:40:27,230 THE DISEASE? 1393 00:40:27,230 --> 00:40:30,400 YOU OFTEN WILL HAVE NO IDEA. 1394 00:40:30,400 --> 00:40:31,067 THE INITIAL OF TIMES THAT I'M IN 1395 00:40:31,067 --> 00:40:32,936 A CONSENT DISCUSSION AND SOMEONE 1396 00:40:32,936 --> 00:40:35,171 WHO LOOKS LIKE ME SAYS, HAS THIS 1397 00:40:35,171 --> 00:40:36,472 BEEN STUDIED IN BLACK PEOPLE? 1398 00:40:36,472 --> 00:40:39,642 AND I HAVE TO SAY, ACTUALLY, NO. 1399 00:40:39,642 --> 00:40:41,377 AND THIS FIRST-IN-HUMAN TRIAL WE 1400 00:40:41,377 --> 00:40:43,413 HAVE NOT ENROLLED A BLACK PERSON 1401 00:40:43,413 --> 00:40:43,713 YET. 1402 00:40:43,713 --> 00:40:45,048 HOWEVER, BASED ON HOW THESE 1403 00:40:45,048 --> 00:40:46,716 CELLS WORK, I WOULD NOT THINK 1404 00:40:46,716 --> 00:40:49,419 THAT THERE IS A SCIENTIFIC 1405 00:40:49,419 --> 00:40:52,855 REASON FOR THIS THERAPY TO HAVE 1406 00:40:52,855 --> 00:40:55,758 A DIFFERENT SAFETY PROFILE OR 1407 00:40:55,758 --> 00:40:56,392 DIFFERENT EFFICACY. 1408 00:40:56,392 --> 00:40:57,560 BUT YOU KNOW WHAT? 1409 00:40:57,560 --> 00:40:59,195 IT'S REALLY IMPORTANT TO KNOW. 1410 00:40:59,195 --> 00:41:01,030 AND IT'S UNACCEPTABLE NOT TO 1411 00:41:01,030 --> 00:41:01,564 KNOW. 1412 00:41:01,564 --> 00:41:03,666 SO, I DO THINK REPRESENTATION IS 1413 00:41:03,666 --> 00:41:03,933 KEY. 1414 00:41:03,933 --> 00:41:06,169 AND BEING COMFORTABLE ANSWERING 1415 00:41:06,169 --> 00:41:07,837 QUESTIONS ABOUT THAT WHEN 1416 00:41:07,837 --> 00:41:09,339 PATIENTS ASK YOU. 1417 00:41:09,339 --> 00:41:11,741 IS IT APPROPRIATE TO TEST 1418 00:41:11,741 --> 00:41:12,976 HETEROGENEITY OF EFFECT? 1419 00:41:12,976 --> 00:41:14,577 DEMOGRAPHIC DATA THERE, WE ALL 1420 00:41:14,577 --> 00:41:17,146 NONE 2024, THESE SHOULD BE SELF 1421 00:41:17,146 --> 00:41:17,547 REPORTED. 1422 00:41:17,547 --> 00:41:19,582 WE CAN'T GO DOWN LIKE, THAT 1423 00:41:19,582 --> 00:41:21,217 PERSON LOOKS LIKE -- CHECK THIS 1424 00:41:21,217 --> 00:41:21,384 OFF. 1425 00:41:21,384 --> 00:41:23,252 BUT WE ALSO HAVE TO RECOGNIZE 1426 00:41:23,252 --> 00:41:25,555 THAT THOSE -- HAS ANYONE HAD A 1427 00:41:25,555 --> 00:41:27,256 PATIENT BE CONFUSED WHEN YOU 1428 00:41:27,256 --> 00:41:29,692 HAND THEM A RACE AND ETHNICITY 1429 00:41:29,692 --> 00:41:29,959 FORM? 1430 00:41:29,959 --> 00:41:31,060 OUR PATIENTS CONFUSED ALL THE 1431 00:41:31,060 --> 00:41:31,627 TIME. 1432 00:41:31,627 --> 00:41:33,296 I DO NOT IDENTIFY AS ANY OF 1433 00:41:33,296 --> 00:41:33,629 THESE. 1434 00:41:33,629 --> 00:41:34,964 THIS IS AN AMERICAN THING, 1435 00:41:34,964 --> 00:41:35,164 RIGHT? 1436 00:41:35,164 --> 00:41:36,899 WE HAVE PATIENTS FROM ALL OVER 1437 00:41:36,899 --> 00:41:38,368 THE WORLD AND ANCESTRY ALL OVER 1438 00:41:38,368 --> 00:41:39,268 THE WORLD. 1439 00:41:39,268 --> 00:41:40,370 PEOPLE ARE OFTEN CONFUSED AND 1440 00:41:40,370 --> 00:41:44,073 SAY I DON'T IDENTIFY AS WHITE. 1441 00:41:44,073 --> 00:41:46,542 I IDENTIFY AS HISPANIC/LATINO. 1442 00:41:46,542 --> 00:41:47,677 THAT'S ETHNICITY. 1443 00:41:47,677 --> 00:41:49,579 BUT I DON'T IDENTIFY AS WHITE. 1444 00:41:49,579 --> 00:41:52,582 SO IT'S REALLY SOMETHING THAT 1445 00:41:52,582 --> 00:41:54,050 THERE ARE EXPANDED CATEGORIES 1446 00:41:54,050 --> 00:41:56,352 THAT PEOPLE ARE TRYING TO START 1447 00:41:56,352 --> 00:41:58,621 USING THAT CAPTURE THAT GRANULAR 1448 00:41:58,621 --> 00:42:00,023 DATA BUT HAVE EXPANDED 1449 00:42:00,023 --> 00:42:01,224 CATEGORIES WHERE PEOPLE CAN 1450 00:42:01,224 --> 00:42:02,592 LITERALLY TELL WHAT THEY 1451 00:42:02,592 --> 00:42:04,927 IDENTIFY AS AND THEY ARE A LOT 1452 00:42:04,927 --> 00:42:07,764 EASIER TO USE. 1453 00:42:07,764 --> 00:42:09,766 SHORTENING CONSENT FORMS. 1454 00:42:09,766 --> 00:42:11,100 INCORPORATING BRIEF OVERVIEW. 1455 00:42:11,100 --> 00:42:13,102 ANY TIME I DO A CONSENT 1456 00:42:13,102 --> 00:42:14,170 DISCUSSION WHETHER ABOUT A 1457 00:42:14,170 --> 00:42:15,972 SINGLING MEDICATION OR A COMPLEX 1458 00:42:15,972 --> 00:42:18,674 STUDY, I SAY, LOOK, STUFF 1459 00:42:18,674 --> 00:42:20,376 HAPPENS IN AMERICA THAT WAS 1460 00:42:20,376 --> 00:42:21,644 UNACCEPTABLE IN THE PAST WHEN IT 1461 00:42:21,644 --> 00:42:23,112 RELATED TO NOT DOING INFORMED 1462 00:42:23,112 --> 00:42:23,813 CONSENT FOR RESEARCH. 1463 00:42:23,813 --> 00:42:25,181 AND BECAUSE OF ALL OF THAT 1464 00:42:25,181 --> 00:42:28,084 HORRIBLE STUFF, WE HAVE 1000 1465 00:42:28,084 --> 00:42:28,718 STAFF GUARDS IN PLACE TO MAKE 1466 00:42:28,718 --> 00:42:30,319 SURE IT NEVER HAPPENS AGAIN. 1467 00:42:30,319 --> 00:42:32,188 SO I TELL EVERY PATIENT THAT 1468 00:42:32,188 --> 00:42:33,356 BECAUSE I WOULDN'T WANT ANY OF 1469 00:42:33,356 --> 00:42:33,756 THAT. 1470 00:42:33,756 --> 00:42:34,690 AND TALK ABOUT THE STANDARD OF 1471 00:42:34,690 --> 00:42:36,359 CARE VERSUS THE RESEARCH. 1472 00:42:36,359 --> 00:42:39,662 AND THEN OFFERING OTHER FORMATS. 1473 00:42:39,662 --> 00:42:44,100 EVERYONE ISN'T DOWN FOR 1474 00:42:44,100 --> 00:42:44,634 HOUR-AND-A-HALF SHUT DOWN 1475 00:42:44,634 --> 00:42:46,502 FACE-TO-FACE AND MULTIPLE PACKS 1476 00:42:46,502 --> 00:42:46,769 OF PAPER. 1477 00:42:46,769 --> 00:42:48,104 WE HAVE TO THINK, ESPECIALLY A 1478 00:42:48,104 --> 00:42:50,073 TRIAL WE'RE LEADING OR A 1479 00:42:50,073 --> 00:42:50,807 PHARMACEUTICAL COMPANY SAYING WE 1480 00:42:50,807 --> 00:42:52,508 WANT YOU TO WORK ON THIS TRIAL, 1481 00:42:52,508 --> 00:42:53,376 ABOUT HAVING THINGS THAT ARE 1482 00:42:53,376 --> 00:42:54,110 EASIER TO UNDERSTAND. 1483 00:42:54,110 --> 00:42:56,245 AND THEN FOR ME IN TEXAS, AND I 1484 00:42:56,245 --> 00:42:57,947 KNOW IF ARE YOU TOO, WE HAVE TO 1485 00:42:57,947 --> 00:43:00,116 THINK ABOUT BARRIERS TO 1486 00:43:00,116 --> 00:43:02,385 ENROLLMENT FOR ASYLUM SEEKERS 1487 00:43:02,385 --> 00:43:04,387 AND REFUGEES AND IMMIGRANTS AND 1488 00:43:04,387 --> 00:43:05,822 CONCERNS ABOUT PROVIDING 1489 00:43:05,822 --> 00:43:06,155 DOCUMENTATION. 1490 00:43:06,155 --> 00:43:07,190 WE WERE GOVERNMENT FUNDED, 1491 00:43:07,190 --> 00:43:08,958 THAT'S A BADGE OF HONOR. 1492 00:43:08,958 --> 00:43:10,793 MY STUDY IS GOVERNMENT FUNDED. 1493 00:43:10,793 --> 00:43:12,395 WHEN YOU ASK PEOPLE WHAT THAT 1494 00:43:12,395 --> 00:43:13,696 MEANS, THE NUMBER OF PEOPLE THAT 1495 00:43:13,696 --> 00:43:15,431 BELIEVE THAT THAT MEANS YOU'RE 1496 00:43:15,431 --> 00:43:16,699 AUTOMATICALLY SHARING LOTS OF 1497 00:43:16,699 --> 00:43:18,901 THEIR INFORMATION WITH THE 1498 00:43:18,901 --> 00:43:19,402 GOVERNMENT, THE SPOOKY 1499 00:43:19,402 --> 00:43:21,137 GOVERNMENT, TO COME AFTER 1500 00:43:21,137 --> 00:43:22,505 THEM -- WE HAVE TO REMEMBER THAT 1501 00:43:22,505 --> 00:43:24,340 WE ARE EXPLAINING WHAT THAT 1502 00:43:24,340 --> 00:43:27,510 MEANS WHEN WE'RE SAYING IT. 1503 00:43:27,510 --> 00:43:28,411 CULTURALLY COMPETENT 1504 00:43:28,411 --> 00:43:28,778 COMMUNICATION. 1505 00:43:28,778 --> 00:43:29,812 WE HEAR ABOUT THIS A LOT. 1506 00:43:29,812 --> 00:43:32,415 I DO A LOT OF TRAININGS ON THIS. 1507 00:43:32,415 --> 00:43:34,250 IT INCLUDES ADDRESSING 1508 00:43:34,250 --> 00:43:34,884 HISTORICAL EVENTS THAT ARE TOUGH 1509 00:43:34,884 --> 00:43:35,318 TO TALK ABOUT. 1510 00:43:35,318 --> 00:43:37,220 WE KNOW THAT THERE IS EVIDENCE 1511 00:43:37,220 --> 00:43:39,288 THAT SAYS THAT IT CAN HELP IF A 1512 00:43:39,288 --> 00:43:41,691 TEAM MEMBER OR PROVIDER HAS A 1513 00:43:41,691 --> 00:43:42,692 SHARED CULTURAL BACKGROUND WITH 1514 00:43:42,692 --> 00:43:42,959 SOMEONE. 1515 00:43:42,959 --> 00:43:44,894 WE KNOW THAT THAT IS NOT THE 1516 00:43:44,894 --> 00:43:47,330 REALITY OF TODAY. 1517 00:43:47,330 --> 00:43:49,632 BUT, THE POINT IS THAT IF ANY OF 1518 00:43:49,632 --> 00:43:51,100 US, IF SOMEONE SAYS, WHAT ABOUT 1519 00:43:51,100 --> 00:43:51,567 THIS? 1520 00:43:51,567 --> 00:43:53,336 I'M WORRIED ABOUT 1521 00:43:53,336 --> 00:43:54,770 EXPERIMENTATION, WE KNOW WHAT WE 1522 00:43:54,770 --> 00:43:55,004 KNOW. 1523 00:43:55,004 --> 00:43:56,706 WE KNOW HOW LONG IT TOOK TO GET 1524 00:43:56,706 --> 00:43:59,208 THAT STUDY THROUGH THE I ARE. 1525 00:43:59,208 --> 00:43:59,909 B. 1526 00:43:59,909 --> 00:44:00,543 I KNOW HOW MANY CORRESPOND 1527 00:44:00,543 --> 00:44:02,011 UNDERSTAND I HAVE WITH THE FDA. 1528 00:44:02,011 --> 00:44:05,148 I KNOW HOW LONG THAT DATA SAFETY 1529 00:44:05,148 --> 00:44:06,315 MONITORING REPORT IS THAT I HAVE 1530 00:44:06,315 --> 00:44:07,283 TO DO. 1531 00:44:07,283 --> 00:44:09,819 BEING ABLE TO SAY TO PEOPLE, I 1532 00:44:09,819 --> 00:44:11,754 GET IT THE MISTRUST. 1533 00:44:11,754 --> 00:44:13,156 LET ME TELL YOU ALL THE 1534 00:44:13,156 --> 00:44:14,123 SAFEGUARDS IN PLACE FOR YOU. 1535 00:44:14,123 --> 00:44:16,859 AND THEN RECOGNIZING OUR BIASES 1536 00:44:16,859 --> 00:44:18,394 ARE REALLY IMPORTANT. 1537 00:44:18,394 --> 00:44:20,363 AND SO I DO ENCOURAGE Y'ALL TO 1538 00:44:20,363 --> 00:44:21,831 USE YOUR SCIENTIFIC AND CLINICAL 1539 00:44:21,831 --> 00:44:23,366 EXPERTISE TO ADVOCATE. 1540 00:44:23,366 --> 00:44:25,501 IT MAY NOT BE SPECIFICALLY FOR 1541 00:44:25,501 --> 00:44:27,737 YOU ALL OR NIH OR POLICY CHANGE, 1542 00:44:27,737 --> 00:44:29,238 BUT YOU'RE ADVOCATE NOTHING 1543 00:44:29,238 --> 00:44:29,539 OTHER WAYS. 1544 00:44:29,539 --> 00:44:30,806 ONE THING THAT IS IMPORTANT TO 1545 00:44:30,806 --> 00:44:32,241 ME IS EVERY TIME I PUBLISH 1546 00:44:32,241 --> 00:44:32,975 SOMETHING ABOUT RESEARCH, I'M 1547 00:44:32,975 --> 00:44:35,545 GOING TO PUBLISH SOMETHING ABOUT 1548 00:44:35,545 --> 00:44:37,013 HOW ACCESS CAN OFFSET POVERTY. 1549 00:44:37,013 --> 00:44:39,482 HOW WE NEED A MULTIPRONGED 1550 00:44:39,482 --> 00:44:40,783 EFFECT TO GET ACCESS TO THESE 1551 00:44:40,783 --> 00:44:41,417 CAR-T CELLS. 1552 00:44:41,417 --> 00:44:42,985 I GO TO CONGRESS A LOT TO TALK 1553 00:44:42,985 --> 00:44:45,021 ABOUT THESE EXCITING THERAPIES 1554 00:44:45,021 --> 00:44:46,822 AND THEN TALK ABOUT ALL OF THE 1555 00:44:46,822 --> 00:44:48,791 LIMITATIONS OF BRINGING THESE 1556 00:44:48,791 --> 00:44:49,959 OUT AND HAVE WORKED WITH THE 1557 00:44:49,959 --> 00:44:51,627 BIDEN AND HARRIS ADMINISTRATION 1558 00:44:51,627 --> 00:44:53,429 ON THE CANCER GENE THERAPY AND 1559 00:44:53,429 --> 00:44:54,931 SICKLE CELL GENE THERAPY. 1560 00:44:54,931 --> 00:44:56,866 THE COOL THING IS THAT PEOPLE 1561 00:44:56,866 --> 00:44:59,569 RECOGNIZE HOW EXCITING OUR 1562 00:44:59,569 --> 00:45:01,070 SCIENCE IS AND OFTEN, IT'S 1563 00:45:01,070 --> 00:45:02,305 COMMON KNOWLEDGE TO US. 1564 00:45:02,305 --> 00:45:04,440 IT'S HARD TO GET TO THIS THERAPY 1565 00:45:04,440 --> 00:45:05,808 BUT IT'S NOT COMMON KNOWLEDGE TO 1566 00:45:05,808 --> 00:45:07,743 PEOPLE, ESPECIALLY IN POSITIONS. 1567 00:45:07,743 --> 00:45:09,212 AND IT OFTEN TAKES GETTING THE 1568 00:45:09,212 --> 00:45:10,146 RIGHT PEOPLE AT THE TABLE. 1569 00:45:10,146 --> 00:45:11,981 SO I DO A LOT OF POLICY SUMMIT 1570 00:45:11,981 --> 00:45:14,050 THINGS WITH DIFFERENT ADVOCACY 1571 00:45:14,050 --> 00:45:14,383 ORGANIZATIONS. 1572 00:45:14,383 --> 00:45:15,384 THIS IS LIKE IN THE MIDDLE OF 1573 00:45:15,384 --> 00:45:18,554 COVID AND I'M LIKE, I DON'T KNOW 1574 00:45:18,554 --> 00:45:20,523 Y'ALL, I WILL HAVE MY MASK ON. 1575 00:45:20,523 --> 00:45:21,958 AND THEN ONE OTHER THING, 1576 00:45:21,958 --> 00:45:22,725 SOMETIMES YOU HAVE TO BRING THE 1577 00:45:22,725 --> 00:45:23,926 RESEARCH TO THE PEOPLE. 1578 00:45:23,926 --> 00:45:25,995 SO ONE OF THE BIG THINGS WE DONE 1579 00:45:25,995 --> 00:45:28,030 AT BAYLOR, WE HAVE SAFETY NET 1580 00:45:28,030 --> 00:45:30,366 HOSPITALS THAT ARE LARGELY 1581 00:45:30,366 --> 00:45:31,033 UNINSURED, UNDERREPRESENTED 1582 00:45:31,033 --> 00:45:32,735 POPULATIONS AND WE ARE STARTING 1583 00:45:32,735 --> 00:45:34,337 A CELL THERAPY PROGRAM THERE. 1584 00:45:34,337 --> 00:45:36,372 WE MAKE THE CELLS IN OUR CENTER 1585 00:45:36,372 --> 00:45:37,506 AND WE CAN ABOUT I THINK THEM 1586 00:45:37,506 --> 00:45:40,176 OVER AND WE HAVE TO START WITH 1587 00:45:40,176 --> 00:45:42,612 NON GENE MODIFIED CELLS AND THE 1588 00:45:42,612 --> 00:45:44,247 GOAL IS TO EXPAND THEM. 1589 00:45:44,247 --> 00:45:45,381 AND IT TAKES A VILLAGE. 1590 00:45:45,381 --> 00:45:46,549 YOU CAN PARTNER. 1591 00:45:46,549 --> 00:45:49,819 I JUST GOT A P20 GRANT FROM NIH, 1592 00:45:49,819 --> 00:45:53,723 A PARTNERSHIP OF A COMPREHENSIVE 1593 00:45:53,723 --> 00:45:56,459 CANCER CENTER WITH PREDOMINANTLY 1594 00:45:56,459 --> 00:45:57,593 UNDERREPRESENTED SERVING 1595 00:45:57,593 --> 00:45:57,994 INSTITUTIONS. 1596 00:45:57,994 --> 00:46:01,063 SO I WORK WITH RESEARCH AND 1597 00:46:01,063 --> 00:46:02,832 CANCER RESEARCH EDUCATION, 1598 00:46:02,832 --> 00:46:04,066 OUTREACH, ALL KINDS OF COOL 1599 00:46:04,066 --> 00:46:04,433 STUFF. 1600 00:46:04,433 --> 00:46:06,102 SO, WHERE DO WE GO FROM HERE? 1601 00:46:06,102 --> 00:46:09,071 SO I WANT TO ENCOURAGE YOU WHEN 1602 00:46:09,071 --> 00:46:09,605 YOU'RE PRESENTING TUBES TO 1603 00:46:09,605 --> 00:46:10,273 PARTICIPATE IN RESEARCH, 1604 00:46:10,273 --> 00:46:12,241 REMEMBER THAT A LACK OF INTEREST 1605 00:46:12,241 --> 00:46:14,243 MAY BE DUE TO LACK OF ADEQUATE 1606 00:46:14,243 --> 00:46:17,480 AWARENESS FOR THAT PATIENT. 1607 00:46:17,480 --> 00:46:18,848 AND OFTEN SAYING IS THERE 1608 00:46:18,848 --> 00:46:19,582 SOMETHING THAT CONCERNS YOU? 1609 00:46:19,582 --> 00:46:21,484 DO YOU WANT TO THINK ABOUT THIS? 1610 00:46:21,484 --> 00:46:23,452 IS IT SOMETHING YOU WANT TO TALK 1611 00:46:23,452 --> 00:46:25,955 ABOUT WITH YOUR FAMILY MEMBERS? 1612 00:46:25,955 --> 00:46:28,591 I'M HAPPY TO ANSWER. 1613 00:46:28,591 --> 00:46:30,326 REMEMBER PRAYER AND SPIRIT AT 1614 00:46:30,326 --> 00:46:31,160 THEY CAN COEXIST. 1615 00:46:31,160 --> 00:46:32,862 THERE IS A LOT OF DATA ON PEOPLE 1616 00:46:32,862 --> 00:46:34,964 WHO PROCLAIM THEY ARE RELIGIOUS 1617 00:46:34,964 --> 00:46:36,766 OR SPIRITUAL, I'M LEAVING THIS 1618 00:46:36,766 --> 00:46:38,768 UP TO GOD OR ALLAH OR -- WILL 1619 00:46:38,768 --> 00:46:41,504 SAY THAT AND THEN THE PROVIDERS 1620 00:46:41,504 --> 00:46:42,538 WILL INTERPRET THAT THIS MEANS 1621 00:46:42,538 --> 00:46:44,407 THEY ARE NOT GOING TO BE AS 1622 00:46:44,407 --> 00:46:45,574 INTERESTED IN THE SCIENCE AND 1623 00:46:45,574 --> 00:46:47,009 NOT INTERESTED IN THIS 1624 00:46:47,009 --> 00:46:47,777 INVESTIGATIONAL TRIAL. 1625 00:46:47,777 --> 00:46:51,480 AND RELYING ON AND USING THE 1626 00:46:51,480 --> 00:46:53,649 LIVED EXPERIENCES, YOU ALL HAVE 1627 00:46:53,649 --> 00:46:54,750 AMAZING FOLKS THAT WORK IN 1628 00:46:54,750 --> 00:46:56,519 HEALTH EQUITY, WORK IN COMMUNITY 1629 00:46:56,519 --> 00:46:57,820 OUTREACH AND ENGAGEMENT AND 1630 00:46:57,820 --> 00:46:59,355 OFTEN YOU MAY HAVE A TRIAL, YOU 1631 00:46:59,355 --> 00:47:01,123 MAY HAVE A STUDY, YOU MAY HAVE A 1632 00:47:01,123 --> 00:47:02,291 TREATMENT THAT YOU'RE HAVING 1633 00:47:02,291 --> 00:47:03,893 TROUBLE WITH AND YOU CAN REACH 1634 00:47:03,893 --> 00:47:05,928 OUT TO THOSE FOLKS TO PROVIDE 1635 00:47:05,928 --> 00:47:06,262 CONSULTATIONS. 1636 00:47:06,262 --> 00:47:07,396 AND THEN JUST SPEAKING ABOUT THE 1637 00:47:07,396 --> 00:47:09,598 FACT THAT WE HAVE TO CLEARLY 1638 00:47:09,598 --> 00:47:11,934 CONSIDER THESE BARRIERS AT EVERY 1639 00:47:11,934 --> 00:47:13,269 ASPECT EVEN BEFORE WE GET TO THE 1640 00:47:13,269 --> 00:47:16,005 CLINIC BUT THEN AFTER. 1641 00:47:16,005 --> 00:47:18,708 I AM THE EPIDEMY OF TEAM SCIENCE 1642 00:47:18,708 --> 00:47:20,876 AND HAVE BENEFITED SO MUCH FROM 1643 00:47:20,876 --> 00:47:22,578 SO MANY WONDERFUL PEOPLE THAT I 1644 00:47:22,578 --> 00:47:24,246 WORK WITH AND ESPECIALLY 1645 00:47:24,246 --> 00:47:25,781 PATIENTS AND FAMILIES AND MY 1646 00:47:25,781 --> 00:47:27,116 FUNDING SOURCES AND ALL OF YOU. 1647 00:47:27,116 --> 00:47:28,617 AND I'M HAPPY TO TAKE ANY 1648 00:47:28,617 --> 00:47:28,884 QUESTIONS. 1649 00:47:28,884 --> 00:47:29,385 THANK YOU. 1650 00:47:29,385 --> 00:47:39,595 [ APPLAUSE ] 1651 00:47:45,134 --> 00:47:46,535 >> THANK YOU SO MUCH. 1652 00:47:46,535 --> 00:47:50,172 IT'S A FANTASTIC TALK. 1653 00:47:50,172 --> 00:47:51,841 I'M ROSIE KAPLAN AT THE ONCOLOGY 1654 00:47:51,841 --> 00:47:52,074 BRANCH. 1655 00:47:52,074 --> 00:47:55,511 THIS IS A TOPIC VERY NEAR TO MY 1656 00:47:55,511 --> 00:47:57,179 HEART BECAUSE WE DO A LOT OF 1657 00:47:57,179 --> 00:47:58,948 CELL THERAPY HERE ALSO AND I GET 1658 00:47:58,948 --> 00:48:00,316 A LOT OF THE QUESTIONS, A LOT OF 1659 00:48:00,316 --> 00:48:01,550 THE TIME YOU BROUGHT UP. 1660 00:48:01,550 --> 00:48:04,320 WE SEE RARE POPULATIONS OF 1661 00:48:04,320 --> 00:48:06,822 PATIENTS, MAYBE WE DON'T HAVE 1662 00:48:06,822 --> 00:48:10,092 THE DIVERSITY THAT WE NEED AND 1663 00:48:10,092 --> 00:48:11,894 THAT'S WHY WE DON'T HAVE 1664 00:48:11,894 --> 00:48:13,696 DIVERSITY IN OUR TRIALS. 1665 00:48:13,696 --> 00:48:15,531 AND WHAT WE FIND HERE IS HARD 1666 00:48:15,531 --> 00:48:19,034 AND I LOVE YOUR THOUGHTS ABOUT 1667 00:48:19,034 --> 00:48:21,670 THAT, WE DON'T EVEN GET TO THE 1668 00:48:21,670 --> 00:48:22,204 REFERRAL STAGE. 1669 00:48:22,204 --> 00:48:23,305 THEY ARE NOT EVEN COMING DO US 1670 00:48:23,305 --> 00:48:24,874 TO KNOW THEY ARE MISSING. 1671 00:48:24,874 --> 00:48:25,608 >> IT WAS SO HUGE. 1672 00:48:25,608 --> 00:48:27,042 WE WERE TALKING ABOUT THIS 1673 00:48:27,042 --> 00:48:27,476 EARLIER. 1674 00:48:27,476 --> 00:48:30,613 WHAT WE HAVE IS A VAST UNDER 1675 00:48:30,613 --> 00:48:30,913 ESTIMATION. 1676 00:48:30,913 --> 00:48:32,882 LIKE WE DO NOT EVEN CAPTURE THE 1677 00:48:32,882 --> 00:48:34,683 INFORMATION ON ALL OF THE 1678 00:48:34,683 --> 00:48:35,484 PATIENTS WHO DON'T EVEN MAKE IT. 1679 00:48:35,484 --> 00:48:39,688 IT TAKES A LEVEL OF NAVIGATIONAL 1680 00:48:39,688 --> 00:48:41,023 HEALTH LITERACY. 1681 00:48:41,023 --> 00:48:44,193 YOU HAVE TO EVEN GET TO THAT 1682 00:48:44,193 --> 00:48:44,393 POINT. 1683 00:48:44,393 --> 00:48:47,496 AND A LOT OF WHAT WE DO IN OUR 1684 00:48:47,496 --> 00:48:48,197 COMMUNITY OUTREACH AND 1685 00:48:48,197 --> 00:48:49,665 ENGAGEMENT OFFICE AND WHAT I'M 1686 00:48:49,665 --> 00:48:52,501 DOING WITH THE CLINICAL TRIALS 1687 00:48:52,501 --> 00:48:54,270 NETWORK IS LITERALLY ALSO 1688 00:48:54,270 --> 00:48:55,805 TALKING TO REFERRING PROVIDERS 1689 00:48:55,805 --> 00:48:57,273 AND -- BECAUSE WE HAVE TO GET 1690 00:48:57,273 --> 00:48:57,473 THERE. 1691 00:48:57,473 --> 00:48:59,208 AND WE WERE JUST TALKING ABOUT A 1692 00:48:59,208 --> 00:49:01,644 PROJECT EARLIER WHERE KNOWING 1693 00:49:01,644 --> 00:49:04,814 WITH REFERRING PROVIDERS WHAT -- 1694 00:49:04,814 --> 00:49:06,215 BECAUSE YOU KNOW THIS TREATMENT 1695 00:49:06,215 --> 00:49:07,116 OPTION IS HERE. 1696 00:49:07,116 --> 00:49:08,851 YOU PROBABLY HAD MENTIONED IT. 1697 00:49:08,851 --> 00:49:10,119 YOU DIDN'T QUITE E-MAIL. 1698 00:49:10,119 --> 00:49:11,387 YOU DIDN'T NECESSARILY REACH OUT 1699 00:49:11,387 --> 00:49:12,521 BECAUSE YOU THOUGHT THE DOOR 1700 00:49:12,521 --> 00:49:13,689 WOULD BE SHUT. 1701 00:49:13,689 --> 00:49:16,826 AND SO, WE HAVE TO MOVE BEYOND 1702 00:49:16,826 --> 00:49:20,062 JUST US IN OUR BUBBLES OF THESE 1703 00:49:20,062 --> 00:49:21,797 HUGE ACADEMIC CENTERS AND WORK 1704 00:49:21,797 --> 00:49:23,432 WITH REFERRING PROVIDERS. 1705 00:49:23,432 --> 00:49:25,134 AND ONE THING WE DID AT OUR 1706 00:49:25,134 --> 00:49:27,236 CENTER, I LOOKED AT ALL OF THE 1707 00:49:27,236 --> 00:49:29,171 PEOPLE THAT HAVE REFERRED FOR 1708 00:49:29,171 --> 00:49:31,474 TRANSPLANT, PEOPLE HAVE 1709 00:49:31,474 --> 00:49:32,441 REFERRED, REFRACTARY PATIENTS. 1710 00:49:32,441 --> 00:49:33,709 NOT NECESSARILY FOR A TRIAL. 1711 00:49:33,709 --> 00:49:35,678 THOSE REFERRING PROVIDERS. 1712 00:49:35,678 --> 00:49:37,213 PUT TOGETHER A PROTOCOL WHERE 1713 00:49:37,213 --> 00:49:38,581 I'M ACTUALLY REACHING OUT TO 1714 00:49:38,581 --> 00:49:40,716 THOSE PROVIDERS, DOING A SURVEY, 1715 00:49:40,716 --> 00:49:42,518 WORKING WITH AN EPIDEMIOLOGIST 1716 00:49:42,518 --> 00:49:43,552 TO DO INTERVIEWS WITH THEM AND 1717 00:49:43,552 --> 00:49:45,120 THEN CAPTURING FROM THE PATIENTS 1718 00:49:45,120 --> 00:49:46,889 AND THEY CAN ENROLL PATIENTS 1719 00:49:46,889 --> 00:49:49,258 THAT THEY PRESENT THE OPTION TO 1720 00:49:49,258 --> 00:49:51,260 FOR US TO FOLLOW-UP WITH. 1721 00:49:51,260 --> 00:49:53,028 SO, A LOT OF IT, I THINK THAT 1722 00:49:53,028 --> 00:49:55,664 WE'RE TAKING THE EASY WAY BUT WE 1723 00:49:55,664 --> 00:49:57,299 ALL -- WE ARE ALL LIKE, THIS IS 1724 00:49:57,299 --> 00:49:58,334 A RARE POPULATION. 1725 00:49:58,334 --> 00:50:00,035 WE GET WHAT WE GET. 1726 00:50:00,035 --> 00:50:02,438 BUT, IF WE CAN TRY TO MAKE SURE 1727 00:50:02,438 --> 00:50:05,007 THAT WE ENSURE THAT EVERY SINGLE 1728 00:50:05,007 --> 00:50:06,642 PATIENT THAT HAS A BARRIER, 1729 00:50:06,642 --> 00:50:08,077 REGARDLESS OF RACE AND 1730 00:50:08,077 --> 00:50:09,778 ETHNICITY, IF THERE IS A 1731 00:50:09,778 --> 00:50:12,314 MECHANISM FOR US TO AT LEAST 1732 00:50:12,314 --> 00:50:15,184 THINK ABOUT HOW WE CAN COUNTER 1733 00:50:15,184 --> 00:50:16,352 ACT THAT, WE UNDOUBTEDLY WILL 1734 00:50:16,352 --> 00:50:18,120 START TO SEE INCREASES IN THE 1735 00:50:18,120 --> 00:50:19,321 NUMBER OF DIVERSE PATIENTS. 1736 00:50:19,321 --> 00:50:21,190 AND WE DON'T CAPTURE NON 1737 00:50:21,190 --> 00:50:24,226 REFERRALS AND WE DON'T CAPTURE 1738 00:50:24,226 --> 00:50:25,828 SCREEN FAILURES WELL. 1739 00:50:25,828 --> 00:50:27,463 AS WELL AS WE SHOULD. 1740 00:50:27,463 --> 00:50:29,365 SO I THINK IT DOES TAKE A 1741 00:50:29,365 --> 00:50:31,400 REFERRING PROVIDER-TYPE NETWORK. 1742 00:50:31,400 --> 00:50:33,402 AND I'D LOVE TO TALK MORE ABOUT 1743 00:50:33,402 --> 00:50:35,938 IT BECAUSE IT'S SOMETHING THAT I 1744 00:50:35,938 --> 00:50:36,939 THINK WE ALL RECOGNIZE. 1745 00:50:36,939 --> 00:50:39,842 LIKE THE ONES THAT DON'T GET 1746 00:50:39,842 --> 00:50:43,412 THERE, ARE THE PROBLEM, RIGHT? 1747 00:50:43,412 --> 00:50:44,480 >> AND MY SECOND QUESTION IS 1748 00:50:44,480 --> 00:50:46,515 ABOUT, WE ARE VERY INTERESTED -- 1749 00:50:46,515 --> 00:50:49,485 MY LABORATORIY IS FOCUSED ON 1750 00:50:49,485 --> 00:50:50,419 TUMOR MICROENVIRONMENT. 1751 00:50:50,419 --> 00:50:51,720 I'M INTERESTED IN THE SOCIAL 1752 00:50:51,720 --> 00:50:54,456 DETERMINANTS OF HEALTH IMPACT ON 1753 00:50:54,456 --> 00:50:55,858 TUMOR MICROENVIRONMENT RESPONSE 1754 00:50:55,858 --> 00:50:58,627 TO THERAPIES, IMMUNE -- 1755 00:50:58,627 --> 00:51:01,497 >> AND THERE IS A SCIENTIFIC 1756 00:51:01,497 --> 00:51:03,666 RATIONAL THAT WE KNOW THAT 1757 00:51:03,666 --> 00:51:05,034 EPIGENETICS, TUMOR 1758 00:51:05,034 --> 00:51:05,434 MICROENVIRONMENT. 1759 00:51:05,434 --> 00:51:06,969 WE KNOW ALL OF THAT IMPACTED BY 1760 00:51:06,969 --> 00:51:09,238 SOCIAL DETERMINANTS OF HEALTH 1761 00:51:09,238 --> 00:51:10,639 COULD POTENTIALLY BE A FACTOR IN 1762 00:51:10,639 --> 00:51:12,675 WHY A CERTAIN POPULATION MAY OR 1763 00:51:12,675 --> 00:51:14,310 MAY NOT RESPOND. 1764 00:51:14,310 --> 00:51:16,612 AND I THINK THAT WE -- THIS IS 1765 00:51:16,612 --> 00:51:18,280 AN EXAMPLE OF SOMEONE WHO IS A 1766 00:51:18,280 --> 00:51:20,583 SCIENTIST HAS A LABORATORY 1767 00:51:20,583 --> 00:51:22,451 SAYING, WAIT, WHAT ABOUT THIS? 1768 00:51:22,451 --> 00:51:24,286 AND I THINK THAT IT'S SO 1769 00:51:24,286 --> 00:51:24,553 IMPORTANT. 1770 00:51:24,553 --> 00:51:25,754 WE DON'T HAVE ENOUGH INFORMATION 1771 00:51:25,754 --> 00:51:27,356 ABOUT IT RIGHT NOW BUT I'M SO 1772 00:51:27,356 --> 00:51:28,591 EXCITED WHEN PEOPLE TALK ABOUT 1773 00:51:28,591 --> 00:51:31,126 IT BECAUSE IT TAKES PARTNERING 1774 00:51:31,126 --> 00:51:32,227 WITH PEOPLE WHO HAVE DIFFERENT 1775 00:51:32,227 --> 00:51:33,762 EXPERIENCES AND THAT IS EXACTLY 1776 00:51:33,762 --> 00:51:34,997 WHAT I DID. 1777 00:51:34,997 --> 00:51:36,198 I WAS LIKE WAIT A MINUTE, BUT I 1778 00:51:36,198 --> 00:51:37,700 ALSO DIDN'T KNOW HOW TO START, 1779 00:51:37,700 --> 00:51:37,900 RIGHT? 1780 00:51:37,900 --> 00:51:39,401 SO I WAS LIKE, I'M GOING TO HAVE 1781 00:51:39,401 --> 00:51:41,570 TO REACH OUT TO SOME TRUE 1782 00:51:41,570 --> 00:51:44,573 DISPARITIES RESEARCHERS AND WORK 1783 00:51:44,573 --> 00:51:45,240 WITH EPIDEMIOLOGISTS AND FOLKS 1784 00:51:45,240 --> 00:51:47,242 AND SO I ENCOURAGE AVERAGE TO DO 1785 00:51:47,242 --> 00:51:47,443 THAT. 1786 00:51:47,443 --> 00:51:48,744 IF YOU HAVE THE -- EVERYONE TO 1787 00:51:48,744 --> 00:51:49,078 DO THAT. 1788 00:51:49,078 --> 00:51:51,080 IF YOU HAVE THE QUESTION, THESE 1789 00:51:51,080 --> 00:51:52,748 FOLKS WILL KNOW HOW TO HELP YOU. 1790 00:51:52,748 --> 00:51:54,116 THAT'S REALLY GRATIFYING. 1791 00:51:54,116 --> 00:51:55,651 >> I REALLY APPRECIATE YOUR 1792 00:51:55,651 --> 00:51:57,219 ADVOCACY FOR IT BECAUSE I ALSO 1793 00:51:57,219 --> 00:52:00,422 THINK LIKE LARGER GROUPS LIKE 1794 00:52:00,422 --> 00:52:01,890 COJ -- THEY NEED TO HELP PARTNER 1795 00:52:01,890 --> 00:52:03,592 WITH US BECAUSE WE ARE JUST ONE 1796 00:52:03,592 --> 00:52:05,294 SITE AND WE REALLY NEED -- 1797 00:52:05,294 --> 00:52:08,197 >> SO WE ARE STARTING -- I 1798 00:52:08,197 --> 00:52:10,466 PRESENTED AT COD SCIENTIFIC 1799 00:52:10,466 --> 00:52:11,967 CHAIRS LAST YEAR AND WE ARE 1800 00:52:11,967 --> 00:52:13,502 STARTING SOME DIFFERENT PROJECTS 1801 00:52:13,502 --> 00:52:15,037 SPECIFICALLY TO TRY TO ADDRESS 1802 00:52:15,037 --> 00:52:15,971 THAT BECAUSE OFTEN YOU LOOK AT 1803 00:52:15,971 --> 00:52:17,673 YOUR DATA AND YOU'RE LIKE, WE'RE 1804 00:52:17,673 --> 00:52:18,474 DOING FINE. 1805 00:52:18,474 --> 00:52:21,076 BUT WE'RE NOT DOING FINE, RIGHT? 1806 00:52:21,076 --> 00:52:24,580 LIKE WE ALL CAN DO BETTER. 1807 00:52:24,580 --> 00:52:26,382 I WOULD LOVE TO FOLLOW-UP WITH 1808 00:52:26,382 --> 00:52:26,548 YOU. 1809 00:52:26,548 --> 00:52:27,082 >> THANK YOU VERY MUCH. 1810 00:52:27,082 --> 00:52:28,584 >> THANK YOU. 1811 00:52:28,584 --> 00:52:30,586 >> HI, THANK YOU FOR A VERY 1812 00:52:30,586 --> 00:52:33,489 INSPIRING AND INFORMATIVE TALK. 1813 00:52:33,489 --> 00:52:34,456 >> THANK YOU DR. PREWIT. 1814 00:52:34,456 --> 00:52:35,724 SEE I REMEMBERED YOUR NAME. 1815 00:52:35,724 --> 00:52:37,593 >> YOU DID, THANK YOU. 1816 00:52:37,593 --> 00:52:40,062 THIS PAST WEEK I MET WITH A 1817 00:52:40,062 --> 00:52:43,065 YOUNG PARENT WHO SEEMED TO HAVE 1818 00:52:43,065 --> 00:52:44,733 JUST PROBLEM AFTER PROBLEM IN 1819 00:52:44,733 --> 00:52:46,669 HIS SOCIAL LIFE. 1820 00:52:46,669 --> 00:52:50,906 AND YOU TOUCHED ON OR TALKED 1821 00:52:50,906 --> 00:52:52,808 ABOUT CONSIDERATIONS WE CAN TAKE 1822 00:52:52,808 --> 00:52:56,578 WITH WRITING A CLINICAL TRIAL IN 1823 00:52:56,578 --> 00:52:59,348 TERMS OF TRYING TO HELP WITH 1824 00:52:59,348 --> 00:52:59,782 RETENTION. 1825 00:52:59,782 --> 00:53:03,285 WHAT IS YOUR ADVICE FOR HELPING 1826 00:53:03,285 --> 00:53:05,621 THE PATIENT OVERCOME BARRIERS IN 1827 00:53:05,621 --> 00:53:07,790 THEIR LIVES THAT IMPACT 1828 00:53:07,790 --> 00:53:08,724 RETENTION? 1829 00:53:08,724 --> 00:53:10,693 >> YES, SO SUCH AN EXCELLENT 1830 00:53:10,693 --> 00:53:11,093 QUESTION. 1831 00:53:11,093 --> 00:53:14,163 YOU KNOW, OUR PATIENTS -- IF YOU 1832 00:53:14,163 --> 00:53:16,565 THINK ABOUT A YOUNG PATIENT 1833 00:53:16,565 --> 00:53:18,300 HOWEVER OLD THIS PATIENT WAS AND 1834 00:53:18,300 --> 00:53:19,768 JUST LIFE IN GENERAL AND THEN 1835 00:53:19,768 --> 00:53:20,836 THROWING CANCER ON TOP OF THAT 1836 00:53:20,836 --> 00:53:22,104 AND THEN THROWING WE ARE GOING 1837 00:53:22,104 --> 00:53:23,672 TO DO ALL OF THIS. 1838 00:53:23,672 --> 00:53:26,175 IT'S SO COMPLEX THAT I THINK IF 1839 00:53:26,175 --> 00:53:28,310 ANY OF OF US FELT -- AND WE'RE 1840 00:53:28,310 --> 00:53:29,678 ALL SUPER PEOPLE, RIGHT? 1841 00:53:29,678 --> 00:53:31,580 BUT IF ANY OF US FELT WE HAD THE 1842 00:53:31,580 --> 00:53:33,048 ABILITY TO HELP THEM NAVIGATE 1843 00:53:33,048 --> 00:53:35,050 THROUGH ALL OF THAT, WE WOULD BE 1844 00:53:35,050 --> 00:53:36,351 REALLY MISTAKEN. 1845 00:53:36,351 --> 00:53:37,586 I THINK ONE OF THE MOST 1846 00:53:37,586 --> 00:53:38,721 IMPORTANT THINGS THAT I TRY TOW 1847 00:53:38,721 --> 00:53:40,389 DO WITH EVERY SINGLE ONE OF MY 1848 00:53:40,389 --> 00:53:42,157 PATIENTS IS HELP THEM UNDERSTAND 1849 00:53:42,157 --> 00:53:44,660 THAT THIS IS NOT NORMAL. 1850 00:53:44,660 --> 00:53:46,729 THE SITUATION YOU'RE IN IS NOT 1851 00:53:46,729 --> 00:53:46,962 NORMAL. 1852 00:53:46,962 --> 00:53:48,297 I DON'T CARE WHAT YOUR SOCIAL 1853 00:53:48,297 --> 00:53:49,998 SUPPORT IS, THIS IS NOT NORMAL. 1854 00:53:49,998 --> 00:53:51,934 SO WHEN THEY SAY, I DON'T NEED 1855 00:53:51,934 --> 00:53:53,702 THE SOCIAL WORKER, I DON'T NEED 1856 00:53:53,702 --> 00:53:56,638 THE FINANCIAL -- I REALLY TRY TO 1857 00:53:56,638 --> 00:53:57,005 ENCOURAGE THEM. 1858 00:53:57,005 --> 00:53:58,207 WE HAVE THEM MEET WITH EVERYONE. 1859 00:53:58,207 --> 00:53:59,208 I THINK IT WILL BE REALLY 1860 00:53:59,208 --> 00:53:59,575 IMPORTANT. 1861 00:53:59,575 --> 00:54:01,210 THIS IS ABOUT TO BE REALLY 1862 00:54:01,210 --> 00:54:04,947 DISRUPTIVE AND WE WANT YOU TO BE 1863 00:54:04,947 --> 00:54:06,949 ABLE TO HAVE THE OPPORTUNITY TO 1864 00:54:06,949 --> 00:54:08,650 DO AS WELL AS POSSIBLE AND PART 1865 00:54:08,650 --> 00:54:09,952 OF DOING AS WELL AS POSSIBLE MAY 1866 00:54:09,952 --> 00:54:12,354 INVOLVE BEING ON A CLINICAL 1867 00:54:12,354 --> 00:54:12,554 TRIAL. 1868 00:54:12,554 --> 00:54:16,191 AND PART OF THAT WILL 1869 00:54:16,191 --> 00:54:16,892 UNDOUBTEDLY -- CANCER EFFECTS 1870 00:54:16,892 --> 00:54:17,526 EVERY ASPECT OF YOUR LIFE. 1871 00:54:17,526 --> 00:54:18,794 WE ALL KNOW THAT. 1872 00:54:18,794 --> 00:54:20,929 I THINK NORMALIZING IT AND 1873 00:54:20,929 --> 00:54:26,802 NORMALIZING THE FACT THAT EVEN A 1874 00:54:26,802 --> 00:54:30,806 HIGH-INCOME ENGINEER -- ENGINEER 1875 00:54:30,806 --> 00:54:31,874 WHO IS VERY WELL READ AND CAN 1876 00:54:31,874 --> 00:54:33,675 TELL YOU ABOUT THE LATEST PAPER 1877 00:54:33,675 --> 00:54:36,745 THAT JUST CAME OUT, MAY BENEFIT 1878 00:54:36,745 --> 00:54:38,514 FROM HAVING SOME SOCIAL WORK 1879 00:54:38,514 --> 00:54:39,014 SUPPORT. 1880 00:54:39,014 --> 00:54:41,049 MAY BENEFIT FROM SEEING 1881 00:54:41,049 --> 00:54:41,784 PSYCHOLOGY. 1882 00:54:41,784 --> 00:54:43,619 AND SO I THINK THAT ALSO THAT 1883 00:54:43,619 --> 00:54:44,853 SELF-EFFICACY, ONE THING THAT WE 1884 00:54:44,853 --> 00:54:48,323 DON'T DO AS WELL, AND I'M A 1885 00:54:48,323 --> 00:54:49,925 PEDIATRICIAN SO I TREAT 1886 00:54:49,925 --> 00:54:51,093 35-YEAR-OLDS, LIKE LET ME HELP 1887 00:54:51,093 --> 00:54:51,260 YOU. 1888 00:54:51,260 --> 00:54:52,427 AND WILL MY SOCIAL WORK 1889 00:54:52,427 --> 00:54:54,196 COLLEAGUES ALWAYS HAVE TO HEP 1890 00:54:54,196 --> 00:54:55,430 ME. 1891 00:54:55,430 --> 00:54:55,764 SELF-EFFICACY. 1892 00:54:55,764 --> 00:54:58,600 WE OFTEN ARE TRYING TO FIX THE 1893 00:54:58,600 --> 00:54:59,701 PROBLEM FOR THEM RATHER THAN 1894 00:54:59,701 --> 00:55:01,603 HELPING THEM GETTING THE TOOLS 1895 00:55:01,603 --> 00:55:02,304 TO FIX IT. 1896 00:55:02,304 --> 00:55:04,406 AND WHAT WE HAVE TO REALIZE IS 1897 00:55:04,406 --> 00:55:05,174 THOSE PROBLEMS AREN'T GOING TO 1898 00:55:05,174 --> 00:55:07,109 GO AWAY WHEN THEY ARE DONE WITH 1899 00:55:07,109 --> 00:55:07,609 THEIR TREATMENT. 1900 00:55:07,609 --> 00:55:09,111 IF WE ARE DOING A LOT OF THINGS 1901 00:55:09,111 --> 00:55:11,380 BUT NOT BUILDING SELF-EFFICACY, 1902 00:55:11,380 --> 00:55:12,247 IT CAN BE CHALLENGING. 1903 00:55:12,247 --> 00:55:14,716 SO I HAVE WATCHED SOCIAL WORKERS 1904 00:55:14,716 --> 00:55:15,851 BUILD SO MUCH SELF-EFFICACY WITH 1905 00:55:15,851 --> 00:55:17,653 PEOPLE AND SAY, WE CAN DO THIS 1906 00:55:17,653 --> 00:55:19,154 BUT WE'RE NOT ABLE TO DO THAT. 1907 00:55:19,154 --> 00:55:20,656 BUT LET ME SHOW YOU THESE 1908 00:55:20,656 --> 00:55:22,491 RESOURCES AND HERE IS YOUR TASK 1909 00:55:22,491 --> 00:55:22,991 FOR TOMORROW. 1910 00:55:22,991 --> 00:55:25,060 HERE IS YOUR TASK FOR FRIDAY. 1911 00:55:25,060 --> 00:55:27,563 I WANT YOU TO BE ABLE TO DO 1912 00:55:27,563 --> 00:55:27,763 THIS. 1913 00:55:27,763 --> 00:55:28,463 BECAUSE IT IS HARD. 1914 00:55:28,463 --> 00:55:30,632 AND I DON'T THINK THERE IS A 1915 00:55:30,632 --> 00:55:33,202 SINGLE ANSWER BUT I TRY TO NOT 1916 00:55:33,202 --> 00:55:35,771 ASSUME THAT I HAVE ALL THE 1917 00:55:35,771 --> 00:55:36,872 ANSWERS ABOUT SUPPORT AND TRY TO 1918 00:55:36,872 --> 00:55:38,640 BRING THE EXPERTS IN. 1919 00:55:38,640 --> 00:55:39,842 BUT THEN FOLLOW-UP WITH THEM. 1920 00:55:39,842 --> 00:55:41,476 BECAUSE OFTEN WE DO 1921 00:55:41,476 --> 00:55:43,846 CONSULTATIONS AND PUT IN THE 1922 00:55:43,846 --> 00:55:44,847 CHART, YOU HAVE BEEN CONSULTED 1923 00:55:44,847 --> 00:55:46,982 AND THEN YOU GAVE ADVICE AND 1924 00:55:46,982 --> 00:55:50,552 THEY DID NOT WHERE THE GLOVES 1925 00:55:50,552 --> 00:55:51,420 YOU ASKED THEM TO. 1926 00:55:51,420 --> 00:55:52,688 WE DO THAT TOO. 1927 00:55:52,688 --> 00:55:53,989 WE BRING PEOPLE IN AND NEVER 1928 00:55:53,989 --> 00:55:55,090 FOLLOW-UP TO KNOW IF THERE IS 1929 00:55:55,090 --> 00:55:55,924 SOMETHING ADDITIONAL WE CAN DO 1930 00:55:55,924 --> 00:55:56,558 TO HELP. 1931 00:55:56,558 --> 00:55:58,293 >> THANK YOU. 1932 00:55:58,293 --> 00:55:59,361 >> YOU'RE WELCOME. 1933 00:55:59,361 --> 00:56:01,496 >> HI, MY NAME IS LIZ. 1934 00:56:01,496 --> 00:56:03,899 ONE OF THE FELLOWS HERE AND I 1935 00:56:03,899 --> 00:56:06,869 JUST -- THIS IS A REALLY 1936 00:56:06,869 --> 00:56:09,705 INSPIRING TALK AND I DID WORK 1937 00:56:09,705 --> 00:56:11,440 PREVIOUSLY WITH EXPANDED ACCESS 1938 00:56:11,440 --> 00:56:13,242 AND IN SOME OF THE CONVERSATIONS 1939 00:56:13,242 --> 00:56:15,277 THAT I'VE HAD PARTICULARLY WITH 1940 00:56:15,277 --> 00:56:17,713 PHARMACEUTICAL COMPANIES, THEY 1941 00:56:17,713 --> 00:56:19,181 HAVE DIVIDES THIS THOUGHT OF, 1942 00:56:19,181 --> 00:56:20,182 OKAY, INDIVIDUALS WHO DON'T MEET 1943 00:56:20,182 --> 00:56:22,351 THE ENTRY CRY TOOIA, IF WE 1944 00:56:22,351 --> 00:56:24,753 CREATE A COHORT THAT WILL ALLOW 1945 00:56:24,753 --> 00:56:25,854 FOR REAL-WORLD DATA BUT THEY ARE 1946 00:56:25,854 --> 00:56:27,756 NOT INCLUDED IN THE DATA POINTS, 1947 00:56:27,756 --> 00:56:30,325 AND IT SEEMS LIKE SUCH A 1948 00:56:30,325 --> 00:56:33,695 DIVERSITY OF DICHOTOMY AND I'M 1949 00:56:33,695 --> 00:56:36,732 JUST CURIOUS JUST BASED ON YOUR 1950 00:56:36,732 --> 00:56:38,467 EXPERIENCE HOW WE SHOULD GO 1951 00:56:38,467 --> 00:56:40,269 ABOUT PROCESSING THESE 1952 00:56:40,269 --> 00:56:40,535 DECISIONS? 1953 00:56:40,535 --> 00:56:42,838 >> I WOULD SAY THAT -- SO WE DID 1954 00:56:42,838 --> 00:56:45,474 THIS -- THERE IS A CUBA EXPANDED 1955 00:56:45,474 --> 00:56:47,409 ACCESS THAT YOU'RE PROBABLY 1956 00:56:47,409 --> 00:56:47,876 FAMILIAR WITH. 1957 00:56:47,876 --> 00:56:49,978 I WENT TO A TALK IT WAS ON A 1958 00:56:49,978 --> 00:56:52,347 PANEL A FEW MONTHS AGO AND IT 1959 00:56:52,347 --> 00:56:55,651 WAS AT NYU AND THEY HAD LOTS OF 1960 00:56:55,651 --> 00:56:56,952 PHARMACEUTICAL FOLKS THERE AND 1961 00:56:56,952 --> 00:56:58,787 IT WAS ALL ABOUT EXPANDED ACCESS 1962 00:56:58,787 --> 00:57:01,523 FOR RARE DISEASES. 1963 00:57:01,523 --> 00:57:02,391 WHICH ESSENTIALLY EVERYTHING WE 1964 00:57:02,391 --> 00:57:04,726 DO IS A RARE DISEASE. 1965 00:57:04,726 --> 00:57:06,094 AND YOU'RE ABSOLUTELY RIGHT. 1966 00:57:06,094 --> 00:57:08,864 AND THEY ARE VERY -- SOME PEOPLE 1967 00:57:08,864 --> 00:57:10,966 WERE -- IT WAS SPECIFICALLY 1968 00:57:10,966 --> 00:57:12,267 ABOUT GENE THERAPIES AND SOME 1969 00:57:12,267 --> 00:57:13,435 PEOPLE ARE ABSOLUTELY NOT. 1970 00:57:13,435 --> 00:57:15,938 WE HAVE TO HAVE THIS AND THAT. 1971 00:57:15,938 --> 00:57:17,339 SO, THEY ARE IN NEED OF YOUR 1972 00:57:17,339 --> 00:57:18,507 PATIENT POPULATIONS AND THEY ARE 1973 00:57:18,507 --> 00:57:20,075 IN NEED OF YOU. 1974 00:57:20,075 --> 00:57:22,344 SO PEOPLE OFTEN THINK THAT YOU 1975 00:57:22,344 --> 00:57:23,578 CAN'T PUSH A PHARMACEUTICAL 1976 00:57:23,578 --> 00:57:24,079 COMPANY. 1977 00:57:24,079 --> 00:57:25,948 BUT I WILL SAY UPFRONT, IT'S 1978 00:57:25,948 --> 00:57:28,183 GOING TO BE VERY CHALLENGING. 1979 00:57:28,183 --> 00:57:30,018 THIS EXCLUSION CRITERIA, IS 1980 00:57:30,018 --> 00:57:31,186 GOING TO BE VERY CHALLENGING FOR 1981 00:57:31,186 --> 00:57:32,721 MY PATIENT POPULATION. 1982 00:57:32,721 --> 00:57:34,589 LET ME TELL YOU WHY. 1983 00:57:34,589 --> 00:57:35,924 AND THEY SAY WELL, WE HAVE TO 1984 00:57:35,924 --> 00:57:36,425 HAVE IT. 1985 00:57:36,425 --> 00:57:37,893 MAYBE WHY CAN DO A SINGLE 1986 00:57:37,893 --> 00:57:38,126 PATIENT. 1987 00:57:38,126 --> 00:57:41,563 I SAY OKAY, BUT I'M NOT WRITING 1988 00:57:41,563 --> 00:57:42,531 THE SINGLE PATIENT. 1989 00:57:42,531 --> 00:57:44,166 YOU'RE GOING TO HAVE TO DO A 1990 00:57:44,166 --> 00:57:45,367 MANAGE ACCESS PROGRAM BECAUSE 1991 00:57:45,367 --> 00:57:46,702 I'M NOT DOING THAT. 1992 00:57:46,702 --> 00:57:47,502 BECAUSE THAT'S NOT SOMETHING 1993 00:57:47,502 --> 00:57:49,271 THAT I SHOULD HAVE TO DO. 1994 00:57:49,271 --> 00:57:50,706 AND IF PEOPLE ARE REPEATEDLY 1995 00:57:50,706 --> 00:57:52,007 TELLING YOU THIS IS A PROBLEM, 1996 00:57:52,007 --> 00:57:55,077 YOU NEED TO LOOK AT IT. 1997 00:57:55,077 --> 00:57:57,079 I DO THINK NOW PHARMACEUTICAL 1998 00:57:57,079 --> 00:57:58,513 COMPANIES ARE NOT -- ARE 1999 00:57:58,513 --> 00:58:00,649 UNLIKELY TO SPEARHEAD REAL WORLD 2000 00:58:00,649 --> 00:58:02,884 APPROACHES BUT IF THERE IS A 2001 00:58:02,884 --> 00:58:04,386 WHOLE REAL-WORLD CONSORT OF 2002 00:58:04,386 --> 00:58:06,355 PATIENTS WHO DID NOT MEET 2003 00:58:06,355 --> 00:58:07,589 CRITERIA BUT GOT EXPANDED 2004 00:58:07,589 --> 00:58:09,291 ACCESS, I DO THINK WITHIN 2005 00:58:09,291 --> 00:58:11,827 ACADEMIA, WE HAVE THE ABILITY TO 2006 00:58:11,827 --> 00:58:13,295 PARTNER WITH INSTITUTIONS AND 2007 00:58:13,295 --> 00:58:16,198 SAY, WE'D LIKE TO STUDY THIS 2008 00:58:16,198 --> 00:58:17,165 REAL-WORLD CONSORT. 2009 00:58:17,165 --> 00:58:19,001 THE PHARMACEUTICAL COMPANIES 2010 00:58:19,001 --> 00:58:21,236 WILL SEE THAT AND WILL OFTEN 2011 00:58:21,236 --> 00:58:22,671 PROVIDE GRANTS TO DO THAT, MONTH 2012 00:58:22,671 --> 00:58:24,439 KNOWY TO DO THAT, SUPPORTS, 2013 00:58:24,439 --> 00:58:25,374 STATISTICAL SUPPORT. 2014 00:58:25,374 --> 00:58:27,175 SO I THINK THAT WHEN YOU 2015 00:58:27,175 --> 00:58:29,177 RECOGNIZE A NEED THAT THERE IS 2016 00:58:29,177 --> 00:58:31,346 AN EXPANDED, EXTENDED 2017 00:58:31,346 --> 00:58:32,147 COMPASSIONATE USE INDICATION 2018 00:58:32,147 --> 00:58:34,783 THAT YOU'RE REPEATING A NUMBER 2019 00:58:34,783 --> 00:58:36,351 OF TIMES -- LIKE WHENEVER YOU 2020 00:58:36,351 --> 00:58:38,387 SEE THAT YOU HAVE DONE IT MORE 2021 00:58:38,387 --> 00:58:39,354 THAN TWICE, THE MOST LIKELY 2022 00:58:39,354 --> 00:58:40,555 THING IS OTHER PEOPLE HAVE DONE 2023 00:58:40,555 --> 00:58:41,823 IT MORE THAN TWICE. 2024 00:58:41,823 --> 00:58:44,126 SO IN THE SAME SPACES WHERE 2025 00:58:44,126 --> 00:58:45,827 YOU'RE WITH YOUR COLLEAGUES, 2026 00:58:45,827 --> 00:58:46,595 TALKING ABOUT WE DON'T HAVE A 2027 00:58:46,595 --> 00:58:49,898 LOT OF DATA ON THESE PATIENTS. 2028 00:58:49,898 --> 00:58:51,233 YOU GO THE ONES I HAD DID WELL 2029 00:58:51,233 --> 00:58:52,567 DESPITE THE FACT THAT THEY 2030 00:58:52,567 --> 00:58:54,102 DIDN'T MEET THIS INCLUSION 2031 00:58:54,102 --> 00:58:55,003 CRITERIA. 2032 00:58:55,003 --> 00:58:57,906 AND THAT WILL OFTEN LEAD TO MORE 2033 00:58:57,906 --> 00:59:00,509 STUDIES AND POTENTIALLY LEAD 2034 00:59:00,509 --> 00:59:01,643 THEM AT SHOULD WE CHANGE THE 2035 00:59:01,643 --> 00:59:02,310 LABEL? 2036 00:59:02,310 --> 00:59:03,712 THEIR BOTTOM LINE IS A LITTLE 2037 00:59:03,712 --> 00:59:04,713 DIFFERENT THAN OURS. 2038 00:59:04,713 --> 00:59:07,349 BUT I DO THINK THAT THERE IS A 2039 00:59:07,349 --> 00:59:09,684 WAY TO, IN ACADEMIA, APPROACH 2040 00:59:09,684 --> 00:59:13,422 THE COMPANY AND SAY, HEY, WE 2041 00:59:13,422 --> 00:59:15,323 KNOW THAT YOU MAY NOT BE 2042 00:59:15,323 --> 00:59:17,192 INTERESTED IN REPORTING ON THOSE 2043 00:59:17,192 --> 00:59:19,094 PATIENTS BUT WE AS THE REAL 2044 00:59:19,094 --> 00:59:20,195 WORLD, TAKING CARE OF THESE 2045 00:59:20,195 --> 00:59:21,763 PATIENTS, WOULD LIKE TO DO A 2046 00:59:21,763 --> 00:59:23,031 REAL-WORLD STUDY. 2047 00:59:23,031 --> 00:59:24,800 AND IT CAN BE A RETROSPECTIVE 2048 00:59:24,800 --> 00:59:26,501 STUDY, GATHER DATA AND THEN 2049 00:59:26,501 --> 00:59:27,803 POTENTIALLY DO SOMETHING 2050 00:59:27,803 --> 00:59:28,103 PROSPECTIVE. 2051 00:59:28,103 --> 00:59:30,138 >> THANK YOU. 2052 00:59:30,138 --> 00:59:31,139 >> YOU'RE WELCOME. 2053 00:59:31,139 --> 00:59:32,107 >> I THINK WE'RE AT TIME. 2054 00:59:32,107 --> 00:59:33,208 >> THANK YOU ALL SO MUCH. 2055 00:59:33,208 --> 00:59:36,011 I REALLY APPRECIATE YOU INVITING 2056 00:59:36,011 --> 00:59:36,611 ME. 2057 00:59:36,611 --> 00:59:41,049 IT'S ALWAYS WONDERFUL TO COME TO 2058 00:59:41,049 --> 00:59:44,619 THE NIH DESPITE THE GETTING INTO 2059 00:59:44,619 --> 00:59:46,021 THE FORTRESS. 2060 00:59:46,021 --> 00:59:47,089 BUT, I ALWAYS LOVE COMING HERE 2061 00:59:47,089 --> 00:59:49,591 AND I REALLY APPRECIATE Y'ALL'S 2062 00:59:49,591 --> 00:59:50,425 ATTENTION AND Y'ALL ARE ALL 2063 00:59:50,425 --> 00:59:52,094 DOING GREAT AND,A MAZING THINGS 2064 00:59:52,094 --> 00:59:54,563 AND YOU MAKE ME EXCITED ABOUT 2065 00:59:54,563 --> 00:59:55,063 THE FUTURE! 2066 00:59:55,063 --> 00:59:55,964 THANK YOU! 2067 00:59:55,964 --> 01:00:06,174 [ APPLAUSE ]