1 00:00:06,273 --> 00:00:08,041 WELCOME, EVERYONE. GOOD MORNING AND 2 00:00:08,041 --> 00:00:09,676 WELCOME TO THE OPEN SESSION OF 3 00:00:09,676 --> 00:00:11,779 THE 210TH MEETING OF THE COUNCIL 4 00:00:11,779 --> 00:00:14,481 OF NATIONAL INSTITUTE OF ALLERGY 5 00:00:14,481 --> 00:00:18,485 AND INFECTIOUS DISEASES I'M JEFF 6 00:00:18,485 --> 00:00:20,053 AND CHAIRING TODAY'S OPEN 7 00:00:20,053 --> 00:00:21,555 SESSION. AS YOU KNOW DURING THE 8 00:00:21,555 --> 00:00:22,890 OPEN SESSION OF THE VIRTUAL 9 00:00:22,890 --> 00:00:24,858 MEETING WE ARE JOINED BY 10 00:00:24,858 --> 00:00:26,193 REPRESENTATIVES FROM 11 00:00:26,193 --> 00:00:26,827 PROFESSIONAL AND LAY 12 00:00:26,827 --> 00:00:28,328 ORGANIZATIONS AND PUBLIC WHO 13 00:00:28,328 --> 00:00:31,565 SHARE INTERESTS AND ACTIVITIES 14 00:00:31,565 --> 00:00:33,033 IN COMMON WITH MISSION OF 15 00:00:33,033 --> 00:00:34,968 INSTITUTE AND TODAY AZ MEETING 16 00:00:34,968 --> 00:00:37,971 WILL FOLLOW CONDENSED AGENDA FOR 17 00:00:37,971 --> 00:00:40,941 OPEN SESSION AND FOCUS ON 18 00:00:40,941 --> 00:00:42,643 CONDUCTING COUNCIL BUSINESS AND 19 00:00:42,643 --> 00:00:44,745 COMMENTS WILL BE BRIEF AND WANT 20 00:00:44,745 --> 00:00:46,346 TO ACKNOWLEDGE COUNCIL MEMBERS 21 00:00:46,346 --> 00:00:47,714 AND THANK YOU FOR PARTICIPATION 22 00:00:47,714 --> 00:00:52,219 IN TODAY'S MEETING AND COUNCIL 23 00:00:52,219 --> 00:00:53,353 SERVES CRITICAL ROLE IN 24 00:00:53,353 --> 00:00:55,355 CONTINUING TO MOVE RESEARCH 25 00:00:55,355 --> 00:00:55,889 AGENDA FORWARD. 26 00:00:55,889 --> 00:00:58,091 I WOULD LIKE TO TAKE A COUPLE 27 00:00:58,091 --> 00:01:00,594 MINUTES TO INTRODUCE MYSELF AND 28 00:01:00,594 --> 00:01:03,497 HONORED TO SERVE AS ACTING 29 00:01:03,497 --> 00:01:07,801 DIRECTOR OF NIAID AND CURRENT 30 00:01:07,801 --> 00:01:09,670 INVESTIGATOR IN INTRAMURAL 31 00:01:09,670 --> 00:01:11,738 RESEARCH PROGRAM AND DEPUTY 32 00:01:11,738 --> 00:01:13,674 CHIEF OF LABORATORYIN FERGS 33 00:01:13,674 --> 00:01:16,510 DISEASES IN INTRAMURAL PROGRAM 34 00:01:16,510 --> 00:01:20,981 AND RESEARCH INTERESTS ARE 35 00:01:20,981 --> 00:01:22,015 INFLUENZA VIRUSES AND 36 00:01:22,015 --> 00:01:23,617 DEVELOPMENT OF BROADLY 37 00:01:23,617 --> 00:01:25,953 PROTECTIVE VACCINES AND PRIOR TO 38 00:01:25,953 --> 00:01:33,327 JOINING NIAID IN 2006 I SERVED 39 00:01:33,327 --> 00:01:34,294 AS CHIEF OF DEPARTMENT OF 40 00:01:34,294 --> 00:01:36,864 MOLECULAR PATHOLOGY -- PHD WAS 41 00:01:36,864 --> 00:01:41,335 IN PATHOLOGY AT NAGS 58 CANS 42 00:01:41,335 --> 00:01:42,970 INSTIT 43 00:01:42,970 --> 00:01:43,270 INSTITUTE. 44 00:01:43,270 --> 00:01:45,539 I WILL NOW CALL ON EACH COUNCIL 45 00:01:45,539 --> 00:01:47,407 MEMBER TO INTRODUCE THEMSELVES 46 00:01:47,407 --> 00:01:48,876 AND IDENTIFY WHICH INSTITUTIONS 47 00:01:48,876 --> 00:01:50,444 AND ORGANIZATIONS THEY ARE FROM 48 00:01:50,444 --> 00:01:56,216 AND PROFESSOR ELTRAVAND. 49 00:01:56,216 --> 00:01:56,416 BY : 50 00:01:56,416 --> 00:01:59,253 >> I'M AT UCLA AND INTERESTS IN 51 00:01:59,253 --> 00:02:03,924 HIV PATHOGENESIS AND 52 00:02:03,924 --> 00:02:06,527 PARTICULARLY PREGNANT WOMEN AND 53 00:02:06,527 --> 00:02:06,793 CHILDREN. 54 00:02:06,793 --> 00:02:07,995 >> THANK YOU. I UNDERSTAND 55 00:02:07,995 --> 00:02:09,930 EMILY BROWN IS NOT ABLE TO JOIN 56 00:02:09,930 --> 00:02:13,867 THE OPEN SESSION AND MOVING TO 57 00:02:13,867 --> 00:02:16,570 PROFESSOR ESTEZ. 58 00:02:16,570 --> 00:02:20,674 >> MARY AND AT BAYLOR COLLEGE OF 59 00:02:20,674 --> 00:02:24,044 MEDICINE AND INTERESTED IN 60 00:02:24,044 --> 00:02:26,680 MOLECULAR VIROLOGY FOCUSED ON 61 00:02:26,680 --> 00:02:28,515 GASTROVIRUSES AND HUMAN INGEST 62 00:02:28,515 --> 00:02:32,653 NAL ORGANOIDS. 63 00:02:32,653 --> 00:02:35,923 >> PROFESSOR GURN. 64 00:02:35,923 --> 00:02:40,260 >> HI I'M PROFESSOR OF 65 00:02:40,260 --> 00:02:43,764 PEDIATRICS AT UNIVERSITY OF 66 00:02:43,764 --> 00:02:45,732 MADISON AND INFLUENCE OF 67 00:02:45,732 --> 00:02:48,835 DEVELOPMENT OF CHILDHOOD ASTHMA. 68 00:02:48,835 --> 00:02:52,839 >> PROFESSOR MORAL. 69 00:02:52,839 --> 00:02:55,842 >> GOOD MORNING I'M A PROFESSOR 70 00:02:55,842 --> 00:02:58,946 AND CHAIR OF THE DEPARTMENT OF 71 00:02:58,946 --> 00:03:03,317 MICROBIOLOGY AND IMMUNOLOGY AT 72 00:03:03,317 --> 00:03:06,119 UNIVERSITY OF TEXAS IN SAN 73 00:03:06,119 --> 00:03:07,955 ANTONIO AND IMMUNOLOGIST WORKING 74 00:03:07,955 --> 00:03:09,323 ON LUPUS. 75 00:03:09,323 --> 00:03:12,426 >> PROFESSOR PALMER. 76 00:03:12,426 --> 00:03:17,364 >> GOOD MORNING I'M GUY PALMER 77 00:03:17,364 --> 00:03:19,900 AND PROFESSOR OF GLOBAL HEALTH 78 00:03:19,900 --> 00:03:23,370 AT WASHINGTON STATE UNIVERSITY 79 00:03:23,370 --> 00:03:26,306 AND WORK ON ZOONOTIC INFECTIOUS 80 00:03:26,306 --> 00:03:28,542 DISEASES. THANK YOU. 81 00:03:28,542 --> 00:03:29,376 >> PROFESSOR PASSKWAL. 82 00:03:29,376 --> 00:03:32,980 >> HELLO. I'M A PROFESSOR OF 83 00:03:32,980 --> 00:03:34,748 PEDIATRICS AND DIRECTOR OF 84 00:03:34,748 --> 00:03:38,151 INSTITUTE FOR CHILDREN'S HEALTH 85 00:03:38,151 --> 00:03:40,520 RESEARCH AT CORNELL IN NEW YORK 86 00:03:40,520 --> 00:03:43,190 AND INTERESTED IN STUDY OF 87 00:03:43,190 --> 00:03:45,892 PATHOGENESIS OF PEDIATRIC 88 00:03:45,892 --> 00:03:48,862 AUTOIMMUNE DISEASES. 89 00:03:48,862 --> 00:03:53,333 >> PROFESSOR PUPILS. 90 00:03:53,333 --> 00:04:03,744 >> >> I'M AT VANDERBILT 91 00:04:36,276 --> 00:04:36,743 UNIVERSITY AND PULMONARY 92 00:04:36,743 --> 00:04:37,344 CRITICAL CARE AND STUDY LUNG 93 00:04:37,344 --> 00:04:37,678 INFLAMMATION. 94 00:04:37,678 --> 00:04:38,311 >> THANK YOU. PROFESSOR SHAW? 95 00:04:38,311 --> 00:04:38,945 >> HI, EVERYONE. I'M MS. SHAH 96 00:04:38,945 --> 00:04:39,546 AND AT CHILDREN'S HOSPITAL IN 97 00:04:39,546 --> 00:04:40,047 CHICAGO AT NORTHWESTERN 98 00:04:40,047 --> 00:04:40,647 UNIVERSITY AND RUN THE POLICY 99 00:04:40,647 --> 00:04:40,981 PROGRAM HERE. 100 00:04:40,981 --> 00:04:41,615 >> THANK YOU EXECUTIVE SECT YEAR 101 00:04:41,615 --> 00:04:42,115 OF COUNCIL IS DR. POW. 102 00:04:42,115 --> 00:04:42,749 >> HI I'M DIRECTOR AT NIAD. 103 00:04:42,749 --> 00:04:43,417 >> THANK YOU DR. BAT ACHARI IS 104 00:04:43,417 --> 00:04:45,986 NOT ABLE TO JOIN US BUT DR. 105 00:04:45,986 --> 00:04:46,453 BIGGER STAFF. 106 00:04:46,453 --> 00:04:48,388 >> HELLO SEAN BIGGER STAFF AND 107 00:04:48,388 --> 00:04:50,957 DIRECTOR OF RESEARCH AT DEFENSE 108 00:04:50,957 --> 00:04:51,324 HEALTH AGENCY. 109 00:04:51,324 --> 00:04:55,195 >> THANK YOU. WE ALSO HAVE DR. 110 00:04:55,195 --> 00:04:55,562 EVANS. 111 00:04:55,562 --> 00:04:59,199 >> GOOD MORNING. CHARLES EVANS 112 00:04:59,199 --> 00:04:59,866 RESEARCH SCIENTIST AT DEPARTMENT 113 00:04:59,866 --> 00:05:03,203 OF VETERANS AFFAIRS AND 114 00:05:03,203 --> 00:05:07,074 PROFESSOR AT NORTHWESTERN 115 00:05:07,074 --> 00:05:07,374 UNIVERSITY. 116 00:05:07,374 --> 00:05:10,811 >> DR. JERN ABEGAN FROM THE CDC. 117 00:05:10,811 --> 00:05:13,113 >> I'M DAN DIRECTOR OF NATIONAL 118 00:05:13,113 --> 00:05:15,615 CENTER FOR EMERGING AND ZOONOTIC 119 00:05:15,615 --> 00:05:18,919 DISEASES AT CDC AND SPENT OF 120 00:05:18,919 --> 00:05:22,823 CAREER IN HEALTH INFECTIONS AND 121 00:05:22,823 --> 00:05:24,691 VARIOUS EMERGING AND ZOONOTIC 122 00:05:24,691 --> 00:05:24,958 SYSTEMS. 123 00:05:24,958 --> 00:05:26,093 >> THANK YOU VERY MUCH AND THANK 124 00:05:26,093 --> 00:05:27,761 YOU ALL FOR YOUR PARTICIPATION 125 00:05:27,761 --> 00:05:29,062 IN THIS IMPORTANT EVENT. 126 00:05:29,062 --> 00:05:31,832 COULD I HAVE SLIDE 2, PLEASE? 127 00:05:31,832 --> 00:05:34,434 SO THE AGENDA FOR TODAY, THE 128 00:05:34,434 --> 00:05:36,103 MEETING WILL BEGIN WITH APPROVAL 129 00:05:36,103 --> 00:05:37,938 OF COUNCIL'S OPERATING 130 00:05:37,938 --> 00:05:40,006 PROCEDURES AND FOLLOWED BY 131 00:05:40,006 --> 00:05:43,944 APPROVAL OF NIAID SUFFICIENT 132 00:05:43,944 --> 00:05:46,046 DATA ON REPORT ON INCLUSION OF 133 00:05:46,046 --> 00:05:48,915 WOMEN AND MINORITIES FISCAL YEAR 134 00:05:48,915 --> 00:05:51,384 2022 THROUGH 2024 AND FOUR 135 00:05:51,384 --> 00:05:53,553 CONCEPTS FROM DIVISION OF 136 00:05:53,553 --> 00:05:57,357 MICROBIOLOGY AND INFECTIOUS 137 00:05:57,357 --> 00:05:58,892 DISEASES FOR APPROVAL. NEXT 138 00:05:58,892 --> 00:06:00,227 SLIDE. 139 00:06:00,227 --> 00:06:02,863 THIS IS A SUMMARY OF THE 140 00:06:02,863 --> 00:06:04,231 OPERATING PROCEDURES AND WE WILL 141 00:06:04,231 --> 00:06:06,933 NOW CONTINUE WITH THE AGENDA 142 00:06:06,933 --> 00:06:08,468 WITH MEETING BEGINNING WITH 143 00:06:08,468 --> 00:06:11,071 APROVL OF COUNCIL'S PROCEDURES 144 00:06:11,071 --> 00:06:13,106 IN MAY COUNCIL RECEIVED DOCUMENT 145 00:06:13,106 --> 00:06:17,410 IN FULL IN ELECTRONIC BOOK MAY I 146 00:06:17,410 --> 00:06:19,379 HAVE A MOTION OF COUNCIL 147 00:06:19,379 --> 00:06:21,148 APPROVAL OF OPERATING 148 00:06:21,148 --> 00:06:21,448 PROCEDURES. 149 00:06:21,448 --> 00:06:22,282 >> SO MOVED. 150 00:06:22,282 --> 00:06:24,718 >> IS THERE A SECOND. 151 00:06:24,718 --> 00:06:25,118 >> SECOND. 152 00:06:25,118 --> 00:06:25,418 >> SECOND. 153 00:06:25,418 --> 00:06:29,322 >> THANK YOU. ALL IN FAVOR OF 154 00:06:29,322 --> 00:06:36,930 OPERATOR PROCEDURES, PLEASE SAY 155 00:06:36,930 --> 00:06:37,330 AYE. 156 00:06:37,330 --> 00:06:39,466 COLLECTIVE: AYE. 157 00:06:39,466 --> 00:06:44,104 >> IT IS APPROVED. NEXT SLIDE. 158 00:06:44,104 --> 00:06:46,940 NEXT ITEM OF BUSINESS IS 159 00:06:46,940 --> 00:06:50,110 APPROVAL OF NIAID SUBMISSION 160 00:06:50,110 --> 00:06:52,612 DATA ON INCLUSION OF WOMEN AND 161 00:06:52,612 --> 00:06:54,414 MINORITIES IN CLIN CAL RESEARCH 162 00:06:54,414 --> 00:06:57,784 FISCAL YEARS 2022 THROUGH 2024 163 00:06:57,784 --> 00:07:00,353 AND JANUARY OF THIS YEAR -- COPY 164 00:07:00,353 --> 00:07:04,157 OF FINAL NIAID FINAL REPORT IS 165 00:07:04,157 --> 00:07:06,760 IN COUNCIL BOOK MAY I HAVE 166 00:07:06,760 --> 00:07:12,933 MOTION FOR APPROVAL OF NIAID 167 00:07:12,933 --> 00:07:23,076 REPORT. 168 00:07:27,647 --> 00:07:27,914 >> SO MOVED. 169 00:07:27,914 --> 00:07:28,381 >> IS THERE A SECOND. 170 00:07:28,381 --> 00:07:28,682 >> SECOND. 171 00:07:28,682 --> 00:07:29,316 >> ALL IN FAVOR OF NIAID REPORT 172 00:07:29,316 --> 00:07:29,683 PLEASE SAY AYE. 173 00:07:29,683 --> 00:07:29,916 >> AYE. 174 00:07:29,916 --> 00:07:30,550 >> ANY OPPOSED? HEARING NONE IT 175 00:07:30,550 --> 00:07:31,718 STANDS AS APPROVED. 176 00:07:31,718 --> 00:07:36,156 NEXT SLIDE. I NOW CALL ON DR. 177 00:07:36,156 --> 00:07:38,959 JOHN ACTING DIRECTOR OF DIVISION 178 00:07:38,959 --> 00:07:41,928 OF MICROBIOLOGY AND INFECTIOUS 179 00:07:41,928 --> 00:07:44,030 DISEASES FOR NEXT PART OF THE 180 00:07:44,030 --> 00:07:47,367 MEETING WITH FOUR CONCEPTS FOR 181 00:07:47,367 --> 00:07:48,535 APPROVAL. DOCTOR, YOU VT FLOOR. 182 00:07:48,535 --> 00:07:50,770 >> GOOD MORNING, EVERYONE. WE 183 00:07:50,770 --> 00:07:52,639 ARE EXCITED WE HAVE FOUR HIGH 184 00:07:52,639 --> 00:07:55,909 PRIORITY CONCEPTS TO PRESENT B 185 00:07:55,909 --> 00:07:58,211 TO THE NIAID COUNCIL. TO BEGIN, 186 00:07:58,211 --> 00:08:02,015 WE -- THERE IS A COUNCIL -- 187 00:08:02,015 --> 00:08:05,952 SORRY THERE IS A CONCEPT CALLED 188 00:08:05,952 --> 00:08:07,454 TUBERCULOSIS RESEARCH UNITS IT 189 00:08:07,454 --> 00:08:11,691 IS A CLINICAL TRIAL OF FROM DR. 190 00:08:11,691 --> 00:08:12,926 ROBINSON WHO WILL PRESENT THAT. 191 00:08:12,926 --> 00:08:23,470 >> GOOD MORNING. JOULE OE CAN 192 00:08:33,980 --> 00:08:34,514 YOU PULL UP MY SLIDES? THANK 193 00:08:34,514 --> 00:08:35,115 YOU. I'M IN THE RESPIRATORY 194 00:08:35,115 --> 00:08:35,749 DISEASE BRANCH PRESENTING 2026 195 00:08:35,749 --> 00:08:36,316 CONCEPT TITLED TUBERCULOSIS 196 00:08:36,316 --> 00:08:36,917 RESEARCH UNITS OR TBRUS FOR 197 00:08:36,917 --> 00:08:37,584 SHORT UNDERSTANDING PATHOGENESIS 198 00:08:37,584 --> 00:08:39,452 OF TUBERCULOSIS AND INTERACTIONS 199 00:08:39,452 --> 00:08:41,922 WITH HOST FOR CLINICAL AND 200 00:08:41,922 --> 00:08:43,924 PRECLINICAL STUDIES AND FOCUS IS 201 00:08:43,924 --> 00:08:46,326 CHARACTERIZING ROLES AND 202 00:08:46,326 --> 00:08:49,396 BACTERIAL HOST HETEROGENEITY AND 203 00:08:49,396 --> 00:08:52,032 DISEASE PROGRESSION AND FINDING 204 00:08:52,032 --> 00:08:56,036 BACTERIAL AND HOSTS RELEVANT TO 205 00:08:56,036 --> 00:08:56,937 DISSEMINATION AND DISEASE STAGE. 206 00:08:56,937 --> 00:08:59,272 THIS IS A RENEWAL WE ARE 207 00:08:59,272 --> 00:09:01,608 SHIFTING FROM U19 MECHANISM TO 208 00:09:01,608 --> 00:09:03,276 PO1 MECHANISM AND ANTICIPATE 3 209 00:09:03,276 --> 00:09:05,612 TO 5 AWARDS WITHIN FIRST YEAR 210 00:09:05,612 --> 00:09:08,915 AND FIRST YEAR TOTAL COST OF 10 211 00:09:08,915 --> 00:09:09,950 MILLION DOLLARS. 212 00:09:09,950 --> 00:09:10,617 NEXT SLIDE. 213 00:09:10,617 --> 00:09:13,053 GLOBALLY TB IS LEADING CAUSE OF 214 00:09:13,053 --> 00:09:14,354 DEATH FROM INFECTIOUS DISEASE 215 00:09:14,354 --> 00:09:18,959 AND 202310.8 MILLION NEW TB 216 00:09:18,959 --> 00:09:22,228 CASES 400,000 OF WHICH WERE DRUG 217 00:09:22,228 --> 00:09:23,797 RESISTENT. 1.2 MILLION 218 00:09:23,797 --> 00:09:25,966 INDIVIDUALS DIED OF TB IN 2023 219 00:09:25,966 --> 00:09:29,336 AND FOLLOWING INHALATION OF TB 220 00:09:29,336 --> 00:09:31,037 SOME INDIVIDUALS -- YES? 221 00:09:31,037 --> 00:09:33,006 >> YOU WERE A SLIDE OFF. I WANT 222 00:09:33,006 --> 00:09:34,641 TO MAKE SURE IT LOOKS LIKE 223 00:09:34,641 --> 00:09:35,909 SLIDES HAVE CAUGHT UP WITH YOU. 224 00:09:35,909 --> 00:09:40,947 >> OKAY. THANK YOU. THANK YOU 225 00:09:40,947 --> 00:09:41,181 GIULIO. 226 00:09:41,181 --> 00:09:43,650 FOLLOWING INHALATION OF TB, SOME 227 00:09:43,650 --> 00:09:47,220 INDIVIDUALS ARE CAPABLE OF 228 00:09:47,220 --> 00:09:48,021 ELIMINATING INFECTION THROUGH 229 00:09:48,021 --> 00:09:50,457 INNATE ADAPTIVE IMMUNE RESPONSES 230 00:09:50,457 --> 00:09:52,058 AND THOSE THAT DON'T CLEAR 231 00:09:52,058 --> 00:09:53,760 INFECTION SPECTRUM OF OUTCOMES 232 00:09:53,760 --> 00:09:57,030 OCCUR AND BEST OUTCOME IS LATENT 233 00:09:57,030 --> 00:10:00,533 TB VIABLE BACTERIA ARE PRESENT 234 00:10:00,533 --> 00:10:03,503 IN THE LUNG AND LATENT TB IS NOT 235 00:10:03,503 --> 00:10:05,672 INFECTIOUS AND LETHAL OUTCOME IS 236 00:10:05,672 --> 00:10:08,241 ACTIVE TB OCCURRING WHEN IMMUNE 237 00:10:08,241 --> 00:10:12,946 CONTROL IS COMPROMISED AND 238 00:10:12,946 --> 00:10:14,614 ESCAPES GRANULOMA IN AIRWAYS AND 239 00:10:14,614 --> 00:10:16,516 SPREADING BACTERIA TO OTHERS AND 240 00:10:16,516 --> 00:10:19,386 THIRD OUTCOME THAT WE HAVE 241 00:10:19,386 --> 00:10:21,021 MINIMAL UNDERSTANDING OF SUB 242 00:10:21,021 --> 00:10:22,622 CLINICAL TB OCCURRING WHEN 243 00:10:22,622 --> 00:10:24,824 INDIVIDUALS HAVE PATHOLOGY AND 244 00:10:24,824 --> 00:10:27,127 POTENTIALLY TRANSMIT TB AND 245 00:10:27,127 --> 00:10:28,628 SYMPTOMS IF PRESENT ARE NOT 246 00:10:28,628 --> 00:10:29,696 RECOGNIZED AND INSUFFICIENT TO 247 00:10:29,696 --> 00:10:31,698 SEEK CARE INDICATED BY ARROWS 248 00:10:31,698 --> 00:10:34,801 AND PERSON'S TB STATUS IS NOT 249 00:10:34,801 --> 00:10:36,669 STATIC AND CAN SHIFT DURING LIFE 250 00:10:36,669 --> 00:10:40,440 AND TREATMENT. NEXT SLIDE, 251 00:10:40,440 --> 00:10:40,840 PLEASE. 252 00:10:40,840 --> 00:10:42,909 WE KNOW FROM DECADES OF BASIC 253 00:10:42,909 --> 00:10:46,046 AND CLINICAL RESEARCH THAT 254 00:10:46,046 --> 00:10:47,647 HETEROGENEITY AT PATHOGEN LEVEL 255 00:10:47,647 --> 00:10:51,718 AND HETEROGENEITY AT HOST LEVEL 256 00:10:51,718 --> 00:10:52,519 HAVE ENORMOUS INFLUENCE WHERE 257 00:10:52,519 --> 00:10:55,422 SOMEONE ENDS UP ON TB SPECTRUM 258 00:10:55,422 --> 00:10:57,924 AND PATHOGEN LEVEL DIVERSITY AND 259 00:10:57,924 --> 00:11:00,393 LINEAGE AND DRUG RESISTANCE AND 260 00:11:00,393 --> 00:11:04,364 ABILITY TO SURVIVE AEROSOL 261 00:11:04,364 --> 00:11:14,874 DROPLETS AND DIFFERENT TISSUE 262 00:11:49,809 --> 00:11:50,376 ENVIRONMENTS HOST LEVEL SEX AGE 263 00:11:50,376 --> 00:11:51,010 COMORBIDITIES AND HOST RESPONSE 264 00:11:51,010 --> 00:11:51,511 AS WELL AS HIV STATUS. 265 00:11:51,511 --> 00:11:51,945 NEXT SLIDE, PLEASE. 266 00:11:51,945 --> 00:11:52,579 TB USE IS LONGSTANDING PROGRAM 267 00:11:52,579 --> 00:11:53,113 INSTRUMENTAL IN DEFINING 268 00:11:53,113 --> 00:11:53,746 BACTERIA AND HOST DETERMINANTS 269 00:11:53,746 --> 00:11:54,380 RELEVANT TO TB ESTABLISHMENT AND 270 00:11:54,380 --> 00:11:54,948 DISSEMINATION AND STAGE AND 271 00:11:54,948 --> 00:11:55,515 ENGAGES IN PRECLINICAL AND 272 00:11:55,515 --> 00:11:56,082 CLINICAL STUDIES IMPROVING 273 00:11:56,082 --> 00:11:56,716 KNOWLEDGE OF TB PATHOGENESIS AND 274 00:11:56,716 --> 00:11:57,317 HOST INTERACTIONS AND IN TURN 275 00:11:57,317 --> 00:11:57,817 INFORMS STRATEGIES FOR 276 00:11:57,817 --> 00:11:58,418 PREVENTION AND TREATMENT AND 277 00:11:58,418 --> 00:11:59,052 DETECTION EACH NEEDED TO END TB 278 00:11:59,052 --> 00:11:59,319 PANDEMIC. 279 00:11:59,319 --> 00:11:59,786 NEXT SLIDE THIS SLIDE 280 00:11:59,786 --> 00:12:00,453 ILLUSTRATES HISTORY IN PROGRAM 281 00:12:00,453 --> 00:12:01,154 SINCE IT BEGAN IN 1994 AND FIRST 282 00:12:01,154 --> 00:12:01,821 TBU WAS A CONTRACT AND FOCUSED 283 00:12:01,821 --> 00:12:02,489 ON CLINICAL RESEARCH. 2014 WE 284 00:12:02,489 --> 00:12:05,959 CONVERTED PROGRAM FROM CONTRACT 285 00:12:05,959 --> 00:12:07,961 TO GRANT RECOMMENDED MECHANISM 286 00:12:07,961 --> 00:12:08,895 ENABLING INSTITUTIONS ACROSS THE 287 00:12:08,895 --> 00:12:12,365 US TO APPLY AND PART OF THE 288 00:12:12,365 --> 00:12:13,032 CONVERSION INTRODUCED 289 00:12:13,032 --> 00:12:13,967 REQUIREMENT THAT APPLICANTS 290 00:12:13,967 --> 00:12:16,069 INCLUDE CLINICAL AND ANIMAL 291 00:12:16,069 --> 00:12:17,737 STUDIES AND OTHER FEATURES OF TB 292 00:12:17,737 --> 00:12:21,374 ARE USED PROJECTS INVOLVING TOOL 293 00:12:21,374 --> 00:12:24,944 DEVELOPMENT AND DISCOVERY OF 294 00:12:24,944 --> 00:12:28,348 BACTERIAL BIOMARKERS AND HOST 295 00:12:28,348 --> 00:12:38,858 BIOMARKERS CORRESPONDING WITH 296 00:12:39,192 --> 00:12:39,626 PROGRESSION AND DISEASE 297 00:12:39,626 --> 00:12:41,327 RESISTANCE. 298 00:12:41,327 --> 00:12:41,628 NEXT SLIDE. 299 00:12:41,628 --> 00:12:43,029 4TBRUS EACH BASED AT DOMESTIC 300 00:12:43,029 --> 00:12:43,663 INSTITUTION WITH PROJECTS WITH 301 00:12:43,663 --> 00:12:44,497 BACTERIAL AND HOST DETERMINANTS 302 00:12:44,497 --> 00:12:46,599 OF TREATMENT AND LISTED HERE 303 00:12:46,599 --> 00:12:47,567 UNDER RESPECTIVE INSTITUTION. 304 00:12:47,567 --> 00:12:51,171 AS MENTIONED PREVIOUSLY TBRU 305 00:12:51,171 --> 00:12:53,306 INCORPORATES CLINICAL STUDIES 306 00:12:53,306 --> 00:12:55,041 AND ANIMAL MODEL STUDIES AND 307 00:12:55,041 --> 00:12:59,078 MOST COMMON BEING AEROSOL 308 00:12:59,078 --> 00:13:07,020 INFECTION OF MICE AND CLINICAL 309 00:13:07,020 --> 00:13:07,654 STUDY REQUIREMENT EXISTING TBRU 310 00:13:07,654 --> 00:13:08,254 USE COLLABORATE WITH SEVERAL 311 00:13:08,254 --> 00:13:10,056 COUNTRIES WITH HIGH TB RATES. 312 00:13:10,056 --> 00:13:20,400 NEXT SLIDE, PLEASE. 313 00:13:26,839 --> 00:13:27,307 TBRU ACHIEVEMENTS ADDRESS 314 00:13:27,307 --> 00:13:27,941 OBJECTIVES OF NIAID TB STRATEGIC 315 00:13:27,941 --> 00:13:28,575 PLAN THAT WE UPDATED IN 2024 -- 316 00:13:28,575 --> 00:13:29,342 TBRU PUBLICATIONS ADDRESSING 317 00:13:29,342 --> 00:13:37,650 OBJECTIVES PUBLISHED IN PAST FEW 318 00:13:37,650 --> 00:13:38,284 YEARS IN PEER REVIEWED CLINICAL 319 00:13:38,284 --> 00:13:38,851 AND BASIC SCIENCE JOURNALS. 320 00:13:38,851 --> 00:13:39,285 NEXT SLIDE, PLEASE. 321 00:13:39,285 --> 00:13:41,321 REGARDS TO SCOPE EACH TBRU MUST 322 00:13:41,321 --> 00:13:43,189 HAVE MINIMUM OF TWO 323 00:13:43,189 --> 00:13:45,291 INTERDEPENDENT RESEARCH PROJECTS 324 00:13:45,291 --> 00:13:48,795 ONE PROJECT MUST INVOLVE ANIMAL 325 00:13:48,795 --> 00:13:50,263 STUDIES AND ONE INVOLVE CLINICAL 326 00:13:50,263 --> 00:13:53,900 STUDIES EACH TBRU MUST ADDRESS 327 00:13:53,900 --> 00:13:56,269 PERSISTENT AND NEW CHALLENGES IN 328 00:13:56,269 --> 00:13:58,438 TB FIELD AND LIST CHALLENGES 329 00:13:58,438 --> 00:14:02,742 LISTED HERE AND THOSE IN ITALICS 330 00:14:02,742 --> 00:14:06,212 BEING NEWER FOESI WHICH WE KNOW 331 00:14:06,212 --> 00:14:08,047 VERY LITTLE AND IN ALIGNMENT 332 00:14:08,047 --> 00:14:10,650 WITH NIH DIRECTOR'S VISION TO 333 00:14:10,650 --> 00:14:13,720 REDUCE ANIMAL USE AND ENCOURAGE 334 00:14:13,720 --> 00:14:15,722 DEVELOPMENT OF EX-VIVO SYSTEMS 335 00:14:15,722 --> 00:14:18,224 AND SEE STUDIES TO BETTER 336 00:14:18,224 --> 00:14:22,528 UNDERSTAND ROLE OF HIV TB 337 00:14:22,528 --> 00:14:22,862 PROGRESSION. 338 00:14:22,862 --> 00:14:28,167 NEXT SLIDE, PLEASE. 339 00:14:28,167 --> 00:14:29,902 TBRUS WILL EXCLUDE CORRELATES OF 340 00:14:29,902 --> 00:14:31,604 PROTECTION STUDIES AND ANALYSIS 341 00:14:31,604 --> 00:14:34,073 OF VACCINE CANDIDATES COVERED BY 342 00:14:34,073 --> 00:14:36,009 OTHER NIAID PROGRAMS AND 343 00:14:36,009 --> 00:14:38,211 EXCLUDING RESEARCH ON PRIMARY 344 00:14:38,211 --> 00:14:39,679 FOCUS ON EPIDEMIOLOGICAL 345 00:14:39,679 --> 00:14:40,079 STUDIES. 346 00:14:40,079 --> 00:14:42,615 AS DOING NOW TBRUS WILL BE 347 00:14:42,615 --> 00:14:44,284 EXPECTED TO COMMUNICATE WITH 348 00:14:44,284 --> 00:14:51,658 EACH OTHER VIA MONTHLY VIRTU 349 00:14:51,658 --> 00:14:53,926 MEETINGS AND THERE IS NO 350 00:14:53,926 --> 00:14:55,428 INTERNATIONAL SITE REQUIREMENT 351 00:14:55,428 --> 00:14:57,263 AND A SUBSTANTIAL CHANGE TO 352 00:14:57,263 --> 00:14:59,165 PROGRAM FROM CURRENT ITERATION 353 00:14:59,165 --> 00:15:00,333 AND CHANGING FUNDING MECHANISM 354 00:15:00,333 --> 00:15:03,903 FROM U19 TO P01 AND REASON FOR 355 00:15:03,903 --> 00:15:07,874 THIS IS U19'S ENTAIL SUBSTANTIAL 356 00:15:07,874 --> 00:15:09,309 PO INVOLVEMENT IN FINANCIAL 357 00:15:09,309 --> 00:15:11,311 DECISION MAKING AND POS NOT 358 00:15:11,311 --> 00:15:15,315 INVOLVED IN SCIENTIFIC DECISION 359 00:15:15,315 --> 00:15:19,652 MAKING IN TBRUS AND ENERGY WE 360 00:15:19,652 --> 00:15:21,621 EXPECT SHIFTING TO MECHANISM AND 361 00:15:21,621 --> 00:15:24,023 REVIEW OF APPLICATIONS OCCUR AT 362 00:15:24,023 --> 00:15:25,992 CSR IN SPECIAL EMPHASIS PANEL 363 00:15:25,992 --> 00:15:32,832 APART FROM TBRUP01 APPLICATIONS 364 00:15:32,832 --> 00:15:35,468 AROUND SCIENCE BE REPLICABLE AND 365 00:15:35,468 --> 00:15:37,103 REPRODUCIBLE AND CONSIDER RIGOR 366 00:15:37,103 --> 00:15:41,307 OF PRIOR RESEARCH SUPPORTING 367 00:15:41,307 --> 00:15:41,641 APPLICATION. 368 00:15:41,641 --> 00:15:42,775 NEXT SLIDE, PLEASE. 369 00:15:42,775 --> 00:15:45,111 I WOULD LIKE TO THANK COUNCIL 370 00:15:45,111 --> 00:15:47,280 MEMBERS FOR PROVIDING 371 00:15:47,280 --> 00:15:48,281 CONSTRUCTIVE FEEDBACK ON THIS 372 00:15:48,281 --> 00:15:50,149 CONCEPT IN RESPONSE TO THEIR 373 00:15:50,149 --> 00:15:52,819 FEEDBACK WE HAVE DEFINED 374 00:15:52,819 --> 00:15:54,587 SUBCLINICAL TB RESEARCH WE WOULD 375 00:15:54,587 --> 00:15:58,091 LIKE TO ENCOURAGE INVESTIGATION 376 00:15:58,091 --> 00:16:01,027 INTO AND INDICATED HOW TBRUS 377 00:16:01,027 --> 00:16:02,261 COMMUNICATE WITH ONE ANOTHER AND 378 00:16:02,261 --> 00:16:04,530 CLARIFY THERE IS NO LONGER 379 00:16:04,530 --> 00:16:05,965 INTERNATIONAL SITE REQUIREMENT 380 00:16:05,965 --> 00:16:09,902 AND REVIEW OF TBRU APPLICATIONS 381 00:16:09,902 --> 00:16:13,306 OCCUR SEPARATE FROM NON-TBRU 382 00:16:13,306 --> 00:16:13,639 APPLICATIONS. 383 00:16:13,639 --> 00:16:16,676 NEXT AND FINAL SLIDE, PLEASE. 384 00:16:16,676 --> 00:16:19,078 CONCLUDING REQUESTING APPROVAL 385 00:16:19,078 --> 00:16:21,314 OF RENEWAL OF CONCEPT OF FISCAL 386 00:16:21,314 --> 00:16:24,550 YEAR 2026 AND OBJECTIVES OF 387 00:16:24,550 --> 00:16:26,119 LONGSTANDING AND PRODUCTIVE 388 00:16:26,119 --> 00:16:29,655 PROGRAM FUNDAMENTAL KNOWLEDGE TO 389 00:16:29,655 --> 00:16:30,990 UNDERSTAND -- HOST OF 390 00:16:30,990 --> 00:16:33,059 PRECLINICAL AND CLINICAL STUDIES 391 00:16:33,059 --> 00:16:34,293 AND FUNDING MECHANISM SWITCHING 392 00:16:34,293 --> 00:16:37,330 FROM U-19 TO P01 MECHANISM 393 00:16:37,330 --> 00:16:39,665 BETTER REFLECTING DEGREE OF 394 00:16:39,665 --> 00:16:41,734 SYNERGY WE EXPECT APPLICANTS TO 395 00:16:41,734 --> 00:16:44,737 ACHIEVE AND PO INPUT INTO 396 00:16:44,737 --> 00:16:46,606 EXPERIMENTAL DESIGN AND 397 00:16:46,606 --> 00:16:49,442 ANTICIPATE 305 AWARDS TOTAL COST 398 00:16:49,442 --> 00:16:51,344 OF 10 MILLION DOLLARS AND THANK 399 00:16:51,344 --> 00:16:54,781 YOU FOR CONSIDERING REQUESTS AND 400 00:16:54,781 --> 00:16:56,349 HAPPY TO TAKE QUESTIONS. 401 00:16:56,349 --> 00:16:58,017 >> THANK YOU, RICH. THIS 402 00:16:58,017 --> 00:16:59,719 ALREADY HAS BEEN DISCUSSED WITH 403 00:16:59,719 --> 00:17:01,320 SEVERAL COUNCIL MEMBERS AND 404 00:17:01,320 --> 00:17:03,256 COMMENTS HAVE BEEN REVIEWED. 405 00:17:03,256 --> 00:17:05,224 I WON'T CALL ON ANY PARTICULAR 406 00:17:05,224 --> 00:17:06,426 COUNCIL MEMBERS. AT THE TIME I 407 00:17:06,426 --> 00:17:08,294 WILL OPEN IT UP FOR GENERAL 408 00:17:08,294 --> 00:17:12,031 QUESTIONS, COMMENTS FROM THE 409 00:17:12,031 --> 00:17:22,408 FULL NIAID COUNCIL. 410 00:17:29,315 --> 00:17:31,083 HEARING NONE. WE WILL VOTE AT 411 00:17:31,083 --> 00:17:34,787 THE END IN THE COUNCIL BOOK. 412 00:17:34,787 --> 00:17:36,656 PROCEEDING TO THE SECOND CONCEPT 413 00:17:36,656 --> 00:17:40,193 FOR CLEARANCE AND IS A LIMITED 414 00:17:40,193 --> 00:17:43,095 COMPETITION UC-7 FOR SUPPORT OF 415 00:17:43,095 --> 00:17:47,600 NATIONAL BIOCONTAINMENT 416 00:17:47,600 --> 00:17:50,002 LABORATORY FOR SUPPORT AND MR. 417 00:17:50,002 --> 00:17:52,438 WILLIAMS WILL DESCRIBE THIS 418 00:17:52,438 --> 00:17:52,738 CONCEPT. 419 00:17:52,738 --> 00:17:56,776 >> THANK YOU. JULIO, WILL YOU 420 00:17:56,776 --> 00:17:59,879 ADVANCE THE NEXT SLIDE FOR ME? 421 00:17:59,879 --> 00:18:00,513 >> YEAH. 422 00:18:00,513 --> 00:18:04,283 >> OKAY. SO TODAY I WILL 423 00:18:04,283 --> 00:18:05,318 PRESENT CONCEPTS FOR THE 424 00:18:05,318 --> 00:18:08,187 OPERATION SUPPORT OF NATIONAL 425 00:18:08,187 --> 00:18:09,422 BIOCONTAINMENT LABORATORIES OR 426 00:18:09,422 --> 00:18:12,358 NBLS AND IS UNDER UC7 MECHANISM 427 00:18:12,358 --> 00:18:17,597 AND RENEWAL WITH ITS UNLIMITED 428 00:18:17,597 --> 00:18:19,499 COMPETITION AND EXPECTED AWARDS 429 00:18:19,499 --> 00:18:23,870 OF TWO FACILITIES CURRENTLY AT 430 00:18:23,870 --> 00:18:24,837 UNIVERSITY OF TEXAS MEDICAL 431 00:18:24,837 --> 00:18:28,274 BRANCH UTMB OR BOSTON 432 00:18:28,274 --> 00:18:28,574 UNIVERSITY. 433 00:18:28,574 --> 00:18:31,477 NEXT SLIDE. 434 00:18:31,477 --> 00:18:33,513 SO A LITTLE HISTORY AND 435 00:18:33,513 --> 00:18:37,316 BACKGROUND BASED IN 2002 BLUE 436 00:18:37,316 --> 00:18:40,887 RIBBON PANEL, NIAID CONTRIBUTED 437 00:18:40,887 --> 00:18:42,388 SIGNIFICANT FUNDS OF 438 00:18:42,388 --> 00:18:44,891 CONSTRUCTION RENOVATION OF 439 00:18:44,891 --> 00:18:47,727 LABORATORIES THAT INCLUDED 12 440 00:18:47,727 --> 00:18:51,564 REGIONAL BIOCONTAINMENT BSL-3 441 00:18:51,564 --> 00:18:52,965 LABORATORIES SHOWN IN BLUE DOTS 442 00:18:52,965 --> 00:18:56,168 ON BOTTOM RIGHT AND TWO NATIONAL 443 00:18:56,168 --> 00:19:00,606 BIOCONTAINMENT BSL-4 444 00:19:00,606 --> 00:19:05,311 LABORATORIES SHOWN IN RED DOTS 445 00:19:05,311 --> 00:19:06,612 BOSTON UNIVERSITY AT GAL VESTON 446 00:19:06,612 --> 00:19:09,749 AND THEY ARE THE NEEDLES FOR 447 00:19:09,749 --> 00:19:12,084 NATIONAL EMERGING INFECTIOUS 448 00:19:12,084 --> 00:19:16,222 DISEASE LABORATORY AND BSL4 449 00:19:16,222 --> 00:19:17,356 LABORATORIES SUPPORTED BY NIAID 450 00:19:17,356 --> 00:19:19,959 ARE CRITICAL PART OF 451 00:19:19,959 --> 00:19:22,028 INFRASTRUCTURE USED FOR 452 00:19:22,028 --> 00:19:24,864 BIORESEARCH IN SAFE AND 453 00:19:24,864 --> 00:19:25,965 ENVIRONMENT. NEXT SLIDE. 454 00:19:25,965 --> 00:19:28,601 THIS IS A TIMELINE SHOWING THE 455 00:19:28,601 --> 00:19:30,169 AWARDS FOR CONSTRUCTION STARTING 456 00:19:30,169 --> 00:19:32,572 IN 2003 AND CONSTRUCTION 457 00:19:32,572 --> 00:19:35,041 BEGINNING MID-2000S FOR THE 458 00:19:35,041 --> 00:19:38,344 NEEDLE AND GNL AND IN COMBINANT 459 00:19:38,344 --> 00:19:43,182 WITH THAT STARTING UC-7 SUPPORT 460 00:19:43,182 --> 00:19:44,951 PRAITIONAL SUPPORT THAT WAS 461 00:19:44,951 --> 00:19:47,653 CRITICAL FOR MAINTAINING 462 00:19:47,653 --> 00:19:51,090 FUNCTIONALITY OF FACILITIES 463 00:19:51,090 --> 00:19:51,891 PROVIDING SUFFICIENT OPERATIONAL 464 00:19:51,891 --> 00:19:54,894 MECHANICAL REGULATORY BURDEN 465 00:19:54,894 --> 00:19:56,262 ACROSS THESE NEXT YEARS. 466 00:19:56,262 --> 00:19:57,263 NEXT SLIDE, PLEASE. 467 00:19:57,263 --> 00:19:59,999 IMPORTANTLY IN TERMS OF AWARD 468 00:19:59,999 --> 00:20:03,169 FACILITIES WERE TO SUPPORT NIAID 469 00:20:03,169 --> 00:20:05,004 BIODEFENSE AGENDA AND APPROVED 470 00:20:05,004 --> 00:20:07,773 BIOMEDICAL RESEARCH ACTIVITIES 471 00:20:07,773 --> 00:20:12,745 FOR 20 YEARS AFTER OCCUPANCY. 472 00:20:12,745 --> 00:20:18,184 PARTICIPATE IN NBL/RBL NETWORK 473 00:20:18,184 --> 00:20:20,886 THAT INCLUDES NIAID INTRAMURAL 474 00:20:20,886 --> 00:20:22,221 FACILITIES ROCKY MOUNTAIN LABS 475 00:20:22,221 --> 00:20:24,590 AND INTEGRATIVE RESEARCH 476 00:20:24,590 --> 00:20:26,058 FACILITY AND BE PREPARED TO 477 00:20:26,058 --> 00:20:28,394 ASSIST IN NATIONAL LOCAL PUBLIC 478 00:20:28,394 --> 00:20:30,896 HEALTH EFFORTS IN EVENTS OF 479 00:20:30,896 --> 00:20:32,064 EMERGENCY. NEXT SLIDE. 480 00:20:32,064 --> 00:20:34,934 SO THIS GIVES YOU SORT OF THE 481 00:20:34,934 --> 00:20:36,969 OPERATION SUPPORT SCOPE. SCOPE 482 00:20:36,969 --> 00:20:39,271 OF THE COVERAGE AND GEARS ON THE 483 00:20:39,271 --> 00:20:41,307 RIGHT AND COLOR GEARS INDICATE 484 00:20:41,307 --> 00:20:45,311 DIFFERENT CORES OF THE UC-7 485 00:20:45,311 --> 00:20:47,146 FUNDING. 486 00:20:47,146 --> 00:20:49,148 FOCUSING MAINLY IN THE LARGE BOX 487 00:20:49,148 --> 00:20:50,583 FACILITY MAINTENANCE AND 488 00:20:50,583 --> 00:20:52,718 OPERATION AND OPERATIONAL 489 00:20:52,718 --> 00:20:53,719 MANAGEMENT MONITORING 490 00:20:53,719 --> 00:20:56,889 CERTIFICATIONS AND PREVENTIVE 491 00:20:56,889 --> 00:20:59,525 NONROUTINE MAINTENANCE BSL-4 492 00:20:59,525 --> 00:21:00,860 EQUIPMENT AND SYSTEMS AND 493 00:21:00,860 --> 00:21:03,062 IMPORTANT COMPONENT IS 494 00:21:03,062 --> 00:21:05,364 BIOSECURITY AND BIOSAFETY 495 00:21:05,364 --> 00:21:08,334 COMPLIANCE ASSOCIATED WITH 496 00:21:08,334 --> 00:21:11,070 SELECTIVE AGENT WORK AND BSL-4 497 00:21:11,070 --> 00:21:13,072 PATHOGENS ARE SELECTIVE AGENTS 498 00:21:13,072 --> 00:21:15,775 AND IMPORTANTLY PRACTICES AND 499 00:21:15,775 --> 00:21:16,542 TRAINING CERTIFICATIONS FOR ALL 500 00:21:16,542 --> 00:21:18,944 STAFF THAT WORK IN THE 501 00:21:18,944 --> 00:21:19,278 LABORATORIES. 502 00:21:19,278 --> 00:21:21,814 YOU ALSO SEE ENVIRONMENTAL 503 00:21:21,814 --> 00:21:23,783 HEALTH AND SAFETY EHS 504 00:21:23,783 --> 00:21:25,317 REQUIREMENTS AND REGULATORY 505 00:21:25,317 --> 00:21:27,086 COMPLIANCE IMPORTANT FOR 506 00:21:27,086 --> 00:21:28,320 SUBMISSION OF PRODUCT 507 00:21:28,320 --> 00:21:30,189 DEVELOPMENT AND DEVELOPMENT 508 00:21:30,189 --> 00:21:32,458 SUPPORTING PRODUCT DEVELOPMENT 509 00:21:32,458 --> 00:21:34,026 IN SUBMISSIONS TO REGULATORY 510 00:21:34,026 --> 00:21:34,293 AGENCIES. 511 00:21:34,293 --> 00:21:37,163 THEN FINALLY THE INTEGRATIVE 512 00:21:37,163 --> 00:21:40,166 SUPPORT SERVICES IN THE LIGHT 513 00:21:40,166 --> 00:21:44,470 BLUE SUPPORTING DIFFERENT 514 00:21:44,470 --> 00:21:45,337 ACTIVITIES VETERINARY IMAGING 515 00:21:45,337 --> 00:21:47,206 AND DEPENDING ON SPECIALTIES AND 516 00:21:47,206 --> 00:21:49,308 EXPERTISE WITHIN THE FACILITIES. 517 00:21:49,308 --> 00:21:51,377 TWO IMPORTANT POINTS AT THE 518 00:21:51,377 --> 00:21:52,878 BOTTOM AND BOTTOM BULLET THAT 519 00:21:52,878 --> 00:21:55,181 DOES NOT DIRECTLY SUPPORT 520 00:21:55,181 --> 00:21:56,482 CONDUCTIVE RESEARCH THAT IS ONLY 521 00:21:56,482 --> 00:21:58,884 THE OPERATIONS AND STAFF. 522 00:21:58,884 --> 00:22:01,153 AND THE EXPECTATION IS THAT THE 523 00:22:01,153 --> 00:22:04,123 NBLS ARE GOING TO RECEIVE ALSO 524 00:22:04,123 --> 00:22:05,658 ADDITIONAL OPERATIONAL SUPPORT 525 00:22:05,658 --> 00:22:09,361 FROM BOTH INSTITUTIONS AND OTHER 526 00:22:09,361 --> 00:22:10,196 OUTSIDE SOURCES. 527 00:22:10,196 --> 00:22:11,230 NEXT SLIDE, PLEASE. 528 00:22:11,230 --> 00:22:15,367 THIS IS A PICTURE OF THE TWO 529 00:22:15,367 --> 00:22:19,171 LABORATORIES, GNL AND NEEDLE 530 00:22:19,171 --> 00:22:21,474 SEEING FROM DOLLARS THAT NIAID 531 00:22:21,474 --> 00:22:22,808 SUPPORTED MAJORITY OF 532 00:22:22,808 --> 00:22:24,810 CONSTRUCTION COSTS FOR BOTH 533 00:22:24,810 --> 00:22:26,178 FACILITIES AND ON RIGHT IN THE 534 00:22:26,178 --> 00:22:29,482 GREEN BOX CAPABILITIES I ELUDED 535 00:22:29,482 --> 00:22:34,920 TO IN TERMS OF IMMUNOLOGIST AND 536 00:22:34,920 --> 00:22:35,888 MODEL DEVELOPMENT AND 537 00:22:35,888 --> 00:22:38,124 NON-CLINICAL GLP STUDIES AND 538 00:22:38,124 --> 00:22:39,792 IMPORTANTLY LAST -- YOU KNOW, 539 00:22:39,792 --> 00:22:41,927 LAST BULLET IS, YOU KNOW, THERE 540 00:22:41,927 --> 00:22:45,798 IS A REALLY STRONG STAFF AND 541 00:22:45,798 --> 00:22:46,665 FACULTY WITHIN THESE 542 00:22:46,665 --> 00:22:49,168 INSTITUTIONS DRIVING INDEPENDENT 543 00:22:49,168 --> 00:22:50,770 RESEARCH PROGRAMS AND ALLOW 544 00:22:50,770 --> 00:22:52,872 FACILITY TO SERVE AS CONTRACTORS 545 00:22:52,872 --> 00:22:55,174 FOR NIAID AND PRECLINICAL 546 00:22:55,174 --> 00:22:57,309 SERVICES COLLABORATING WITH 547 00:22:57,309 --> 00:22:59,445 VARIETY OF OUTSIDE 548 00:22:59,445 --> 00:23:00,746 ORGANIZATIONSACDEMIA AND 549 00:23:00,746 --> 00:23:02,882 INDUSTRY AND INCLUDING 550 00:23:02,882 --> 00:23:03,516 NON-GOVERNMENTAL ORGANIZATIONS 551 00:23:03,516 --> 00:23:06,385 AND OTHER GOVERNMENT FUNDING 552 00:23:06,385 --> 00:23:07,019 OPPORTUNITIES. 553 00:23:07,019 --> 00:23:07,887 NEXT SLIDE. 554 00:23:07,887 --> 00:23:09,789 SO THIS SLIDE GIVES YOU A SORT 555 00:23:09,789 --> 00:23:12,925 OF OVERVIEW AND TOUCH OF SOME 556 00:23:12,925 --> 00:23:13,859 DIFFERENT ACCOMPLISHMENTS 557 00:23:13,859 --> 00:23:16,562 RECENTLY AND FOCUSES ON GNL. 558 00:23:16,562 --> 00:23:19,031 YOU CAN SEE, YOU KNOW, A LOT OF 559 00:23:19,031 --> 00:23:24,303 DIFFERENT VIRUSES AND PATHOGENS, 560 00:23:24,303 --> 00:23:28,474 NIPA AND HEMOAGIC FEVER AND 561 00:23:28,474 --> 00:23:29,942 CONGO AND BREADTH OF DIFFERENT 562 00:23:29,942 --> 00:23:31,343 PATHOGENS THEY ARE ABLE TO 563 00:23:31,343 --> 00:23:34,079 ADDRESS IN TERNLS OF 564 00:23:34,079 --> 00:23:35,281 FUNCTIONALITY AND IF YOU LOOK 565 00:23:35,281 --> 00:23:38,484 YOU WILL SEE MONOCLONAL 566 00:23:38,484 --> 00:23:40,386 ANTIBODIES AND SMALL ANIMALS AND 567 00:23:40,386 --> 00:23:42,421 VACCINES AND DIFFERENT MEDICAL 568 00:23:42,421 --> 00:23:44,023 COUNTERMEASURES ABLE TO ADVANCE 569 00:23:44,023 --> 00:23:45,691 RESEARCH AND DEVELOPMENT FOR. 570 00:23:45,691 --> 00:23:47,026 NEXT SLIDE, PLEASE. 571 00:23:47,026 --> 00:23:49,028 SIMILARLY FOR NEEDLE, YOU SEE 572 00:23:49,028 --> 00:23:52,264 BROAD RANGE OF RNA VIRUSES AND 573 00:23:52,264 --> 00:23:56,635 HEN EPA VIRUSES AND EBOLA 574 00:23:56,635 --> 00:23:56,936 VIRUSES. 575 00:23:56,936 --> 00:23:58,170 IN THIS SLIDE ALSO INDICATES 576 00:23:58,170 --> 00:24:00,239 SOME BASIC RESEARCH AND SOME 577 00:24:00,239 --> 00:24:02,408 UPPER LEFT ONE AND PROCEDURES 578 00:24:02,408 --> 00:24:05,311 FOR DECONTAMINATION AND VIRAL 579 00:24:05,311 --> 00:24:07,446 INACTIVATION AND MIDDLE ONE, 580 00:24:07,446 --> 00:24:10,583 METHODOLOGIES FOR IMAGING 581 00:24:10,583 --> 00:24:12,685 PLATFORM HIGHLIGHT ADVANCEMENTS 582 00:24:12,685 --> 00:24:14,653 THAT EXPERTISE AT FACILITIES ARE 583 00:24:14,653 --> 00:24:18,858 ABLE TO ENGENDER AND MOVE 584 00:24:18,858 --> 00:24:19,124 FORWARD. 585 00:24:19,124 --> 00:24:19,959 NEXT SLIDE. 586 00:24:19,959 --> 00:24:21,861 SO WE HAVE HELPFUL COMMENTS FROM 587 00:24:21,861 --> 00:24:25,164 COUNCIL MEMBERS BACK IN JANUARY. 588 00:24:25,164 --> 00:24:26,532 HIGHLY SUPPORTIVE BECAUSE THE 589 00:24:26,532 --> 00:24:28,634 OPERATIONS AND CAPABILITIES AND 590 00:24:28,634 --> 00:24:30,202 AVAILABILITY OF FACILITIES ARE 591 00:24:30,202 --> 00:24:32,104 REALLY CRITICAL FOR US TO BE 592 00:24:32,104 --> 00:24:34,707 ABLE TO CONDUCT BIODEFENSE 593 00:24:34,707 --> 00:24:36,942 RESEARCH IN SAFE AND SECURE 594 00:24:36,942 --> 00:24:40,412 ENVIRONMENT AND IT IS REALLY 595 00:24:40,412 --> 00:24:43,148 CONSIDERITY KALE THAT MBA FOSTER 596 00:24:43,148 --> 00:24:44,216 COLLABORATIONS WITH EXTERNAL 597 00:24:44,216 --> 00:24:46,685 PARTNERS OF DIFFERENT SHAPES AND 598 00:24:46,685 --> 00:24:50,389 SIZES PHARMACONTRACT RESEARCH 599 00:24:50,389 --> 00:24:50,890 ORGANIZATIONS 600 00:24:50,890 --> 00:24:51,390 NON-GOVERNMENTALMENTAL 601 00:24:51,390 --> 00:24:52,725 ORGANIZATIONS, ET CETERA AND 602 00:24:52,725 --> 00:24:53,359 IMPORTANTLY COORDINATE AND SHARE 603 00:24:53,359 --> 00:24:54,994 BEST PRACTICES THROUGH THIS 604 00:24:54,994 --> 00:24:57,329 NETWORK THAT SERVES AS GREAT WAY 605 00:24:57,329 --> 00:24:59,298 FOR INTERACTING AND SHARING BEST 606 00:24:59,298 --> 00:25:02,234 PRACTICES AND INFORMATION ACROSS 607 00:25:02,234 --> 00:25:04,503 BSL-4 LABORATORIES AND INCLUDING 608 00:25:04,503 --> 00:25:09,008 ROCKY MOUNTAIN LABS, IRF AND 609 00:25:09,008 --> 00:25:12,511 TEXAS RESEARCH BIOMEDICAL 610 00:25:12,511 --> 00:25:14,446 INSTITUTE AND CRITICAL THAT 611 00:25:14,446 --> 00:25:16,215 INSTITUTIONS AND FACILITY ITSELF 612 00:25:16,215 --> 00:25:18,617 WORKS TO BRING IN EXTRA FUNDS IN 613 00:25:18,617 --> 00:25:20,653 ADDITION TO THE SUPPORT THAT WE 614 00:25:20,653 --> 00:25:24,156 PROVIDE. FUNDING THAT CUC7 615 00:25:24,156 --> 00:25:26,191 PROVIDES DOESN'T COVER ENTIRETY 616 00:25:26,191 --> 00:25:29,628 OF COSTS OF OPERATIONS OF BSL-4S 617 00:25:29,628 --> 00:25:31,030 AND REQUIREMENT AND EXPECTATION 618 00:25:31,030 --> 00:25:33,332 THEY WILL BRING IN ADDITIONAL 619 00:25:33,332 --> 00:25:35,467 FUNDS BY DIFFERENT PATHS. 620 00:25:35,467 --> 00:25:41,307 LAST SLIDE REITERATES CONCEPT 621 00:25:41,307 --> 00:25:45,377 AND UC-SERVE LIMITED COMPETITION 622 00:25:45,377 --> 00:25:49,315 FOR TWO AWARDS. THANK YOU. CAN 623 00:25:49,315 --> 00:25:50,749 TAKE QUESTIONS. 624 00:25:50,749 --> 00:25:52,151 >> SEVERAL MEMBERS AND COMMENTS 625 00:25:52,151 --> 00:25:53,786 HAVE BEEN INCORPORATED INTO THE 626 00:25:53,786 --> 00:25:55,387 CONCEPT. AT THIS TIME, I WILL 627 00:25:55,387 --> 00:26:01,293 OPEN IT FOR GENERAL QUESTIONS OR 628 00:26:01,293 --> 00:26:05,331 COMMENTS FROM THE FULL NIAID 629 00:26:05,331 --> 00:26:08,067 COUNCIL. OKAY. THEN AGAIN WE 630 00:26:08,067 --> 00:26:09,868 WILL VOTE IN COUNCIL BOOK AT THE 631 00:26:09,868 --> 00:26:10,069 END. 632 00:26:10,069 --> 00:26:12,838 I WILL MOVE TO THE NEXT WHICH IS 633 00:26:12,838 --> 00:26:16,542 PARTNERSHIPS FOR DEVELOPMENT OF 634 00:26:16,542 --> 00:26:20,813 VACCINES TO PREVENT 635 00:26:20,813 --> 00:26:23,248 MICROBACTERIUM TUBERCULOSIS 636 00:26:23,248 --> 00:26:33,692 INFECTION AND IR1 AND MR. 637 00:26:35,828 --> 00:26:44,236 EICHOLBERG WILL PRESENT. 638 00:26:44,236 --> 00:26:54,847 IKE EL EICHEL 639 00:26:59,318 --> 00:26:59,385 . 640 00:26:59,385 --> 00:27:04,123 >> I'M KATRIN EICHELBERG AND 641 00:27:04,123 --> 00:27:05,424 PARTNERSHIP FOR DEVELOPMENT OF 642 00:27:05,424 --> 00:27:09,261 VACCINES TO PREVENT 643 00:27:09,261 --> 00:27:12,231 MICROBACTERIUM TUBERCULOSIS 644 00:27:12,231 --> 00:27:13,932 INFECTION AND/OR DISEASE AND 645 00:27:13,932 --> 00:27:15,667 OBJECTIVE OF CONCEPT IS 646 00:27:15,667 --> 00:27:17,736 SUPPORTING RESEARCH APPLICATIONS 647 00:27:17,736 --> 00:27:20,339 FOR OBJECTIVE-DRIVEN PROJECT 648 00:27:20,339 --> 00:27:22,074 FOCUSED ON PRECLINICAL 649 00:27:22,074 --> 00:27:25,310 DEVELOPMENT OF LEAD CANDIDATE 650 00:27:25,310 --> 00:27:27,679 VACCINES TO PREVENT INFECTION OR 651 00:27:27,679 --> 00:27:30,215 DISEASE TO INCREASE CLINICAL 652 00:27:30,215 --> 00:27:32,284 PIPELINE OF VIABLE VACCINE 653 00:27:32,284 --> 00:27:34,586 CANDIDATES A NEW PROGRAM 654 00:27:34,586 --> 00:27:38,157 CO-SPONSORED BY DMID IN DIVISION 655 00:27:38,157 --> 00:27:41,293 OF AIDS AND MECHANISM WE PROPOSE 656 00:27:41,293 --> 00:27:45,064 IS R01 MECHANISM. 657 00:27:45,064 --> 00:27:48,400 TB CONTINUES TO BE A LEADING 658 00:27:48,400 --> 00:27:49,701 INFECTIOUS DISEASE KILLER AND 659 00:27:49,701 --> 00:27:52,671 DESPITE THE FACT THAT TB IS 660 00:27:52,671 --> 00:27:54,473 FAIRLY TREATABLE, GLOBALLY CLOSE 661 00:27:54,473 --> 00:28:00,179 TO 3,500 PEOPLE DAY EVERY DAY OF 662 00:28:00,179 --> 00:28:00,846 TB. 663 00:28:00,846 --> 00:28:03,582 TB INCIDENTS RATES IN THE US ARE 664 00:28:03,582 --> 00:28:05,350 CURRENTLY AT HIGHEST RATES IN 665 00:28:05,350 --> 00:28:08,353 PAST DECADE WITH CLOSE TO 10,000 666 00:28:08,353 --> 00:28:11,090 TB CASES REPORTED IN 2023. 667 00:28:11,090 --> 00:28:17,029 A COUPLE OF YEARS AGO, THE WHO 668 00:28:17,029 --> 00:28:20,699 COMMISSIONED AN INVESTMENT 669 00:28:20,699 --> 00:28:25,204 ANALYSIS FOR NEW TB VACCINES AND 670 00:28:25,204 --> 00:28:27,306 REPORT PREDICTED A HIGH RETURN 671 00:28:27,306 --> 00:28:30,142 OF INVESTMENT WITH ABILITY OF A 672 00:28:30,142 --> 00:28:31,743 NEW AND EFFECTIVE VACCINE BEING 673 00:28:31,743 --> 00:28:34,213 ABLE TO AVERT MILLIONS OF CASES 674 00:28:34,213 --> 00:28:37,316 OF DISEASE AND DEATH AS WELL AS 675 00:28:37,316 --> 00:28:39,885 HAVING A SIGNIFICANT DOWNSTREAM 676 00:28:39,885 --> 00:28:41,653 ECONOMIC IMPACT. 677 00:28:41,653 --> 00:28:44,423 CURRENTLY, OUR ONLY LICENSED 678 00:28:44,423 --> 00:28:46,425 VACCINE IS BCG THAT HAS BEEN 679 00:28:46,425 --> 00:28:50,262 GIVEN TO INFANTS FOR MANY YEARS. 680 00:28:50,262 --> 00:28:53,899 ONLY LICENSED VACCINE IN OVER 681 00:28:53,899 --> 00:28:56,268 100 YEARS. 682 00:28:56,268 --> 00:28:59,972 AND IT HELPS BCG IS EFFECTIVE IN 683 00:28:59,972 --> 00:29:02,841 PREVENTING DISSEMINATED DISEASE 684 00:29:02,841 --> 00:29:05,444 IN INFANTS HOWEVER IS NOT 685 00:29:05,444 --> 00:29:07,746 PROTECTIVE IN INVENTING 686 00:29:07,746 --> 00:29:09,314 PULMONARY DISEASE IN ADOLESCENTS 687 00:29:09,314 --> 00:29:11,617 AND ADULTS AND SLIDE SHOWS 688 00:29:11,617 --> 00:29:14,586 CURRENT GLOBAL ACTIVE CLINICAL 689 00:29:14,586 --> 00:29:17,322 TB VACCINE PIPELINE ORGANIZED 690 00:29:17,322 --> 00:29:19,324 HERE BY DIFFERENT PHASES OF 691 00:29:19,324 --> 00:29:20,425 CLINICAL TRIALS AND YOU SEE 692 00:29:20,425 --> 00:29:22,361 DIFFERENT CANDIDATES LISTED THAT 693 00:29:22,361 --> 00:29:24,563 ARE CURRENTLY UNDER 694 00:29:24,563 --> 00:29:26,698 INVESTIGATION. 695 00:29:26,698 --> 00:29:27,266 THESE CANDIDATES REPRESENT 696 00:29:27,266 --> 00:29:29,301 DIFFERENT VACCINE APPROACHES AND 697 00:29:29,301 --> 00:29:32,571 DIFFERENT PLATFORMS AND 698 00:29:32,571 --> 00:29:34,506 INDICATIONS AND DIFFERENT 699 00:29:34,506 --> 00:29:37,242 POPULATIONS AND WHERE IT IS 700 00:29:37,242 --> 00:29:38,644 BEING STUDIED AS WELL AS 701 00:29:38,644 --> 00:29:40,379 DIFFERENT ANTIGENIC 702 00:29:40,379 --> 00:29:40,712 COMPOSITIONS. 703 00:29:40,712 --> 00:29:44,383 WHAT I WOULD LIKE TO POINT OUT 704 00:29:44,383 --> 00:29:46,919 HERE TWO ASPECTS THAT ARE 705 00:29:46,919 --> 00:29:49,388 NOTEWORTHY IS, ONE, IT IS A 706 00:29:49,388 --> 00:29:52,591 FAIRLY SMALL PIPELINE FOR SUCH 707 00:29:52,591 --> 00:29:54,560 AN IMPORTANT PATHOGEN. 708 00:29:54,560 --> 00:29:56,428 SECONDLY, IT IS AN INVERTED 709 00:29:56,428 --> 00:29:56,695 PIPELINE. 710 00:29:56,695 --> 00:29:59,631 WHAT I MEAN IS YOU HAVE VERY FEW 711 00:29:59,631 --> 00:30:02,668 CANDIDATES HERE IN THE PHASE I 712 00:30:02,668 --> 00:30:04,503 AND PHASE I OF CLINICAL TRIALS 713 00:30:04,503 --> 00:30:08,240 AND TYPICALLY YOU SEE FOR OTHER 714 00:30:08,240 --> 00:30:09,541 VACCINE LANDSCAPES YOU SEE A 715 00:30:09,541 --> 00:30:12,844 LARGER LIST OF CANDIDATES IN 716 00:30:12,844 --> 00:30:14,546 PHASE I THAT DROP OUT AS 717 00:30:14,546 --> 00:30:16,682 CLINICAL DEVELOPMENT PROCEEDS. 718 00:30:16,682 --> 00:30:19,084 REALLY, GOAL OF THE CONCEPT IS 719 00:30:19,084 --> 00:30:22,087 TO DEVELOP NEW TB VACCINE 720 00:30:22,087 --> 00:30:25,224 CANDIDATES THAT COULD ENTER 721 00:30:25,224 --> 00:30:28,994 PHASE I CLINICAL TRIALS. 722 00:30:28,994 --> 00:30:33,632 ALL RIGHT. WE HAD IN 2018 A 723 00:30:33,632 --> 00:30:37,302 SIMILAR PROGRAM, A PRIOR TB 724 00:30:37,302 --> 00:30:38,971 PARTNERSHIP PROGRAM AND SUPPORT 725 00:30:38,971 --> 00:30:41,673 OF DESIGN AND DEVELOPMENT OF 726 00:30:41,673 --> 00:30:44,977 VARIOUS VACCINE PLATFORMS AND 727 00:30:44,977 --> 00:30:45,978 APPROACHES WITH MULTIPLE 728 00:30:45,978 --> 00:30:49,881 DIFFERENT IMMUNOGENS AND 729 00:30:49,881 --> 00:30:52,017 SUPPORTED FIVE APPLICATIONS AND 730 00:30:52,017 --> 00:30:53,385 DIFFERENT APPROACHES THAT WERE 731 00:30:53,385 --> 00:30:55,287 INVESTIGATED AND SUPPORTED BY 732 00:30:55,287 --> 00:30:56,989 THIS PREVIOUS PARTNERSHIP 733 00:30:56,989 --> 00:30:59,992 PROGRAM LISTED HERE IN THE BOX. 734 00:30:59,992 --> 00:31:02,027 REPRESENTING DIFFERENT PLATFORMS 735 00:31:02,027 --> 00:31:05,264 AND, AGAIN, ANTIGENIC 736 00:31:05,264 --> 00:31:09,101 COMPOSITIONS AND VACCINE SHOWING 737 00:31:09,101 --> 00:31:12,771 PROMISING IMMUNOGENISTY AND 738 00:31:12,771 --> 00:31:14,906 PROTECTION IN RELEVANT ANIMAL 739 00:31:14,906 --> 00:31:17,542 MODELS POINTING OUT ONE VACCINE 740 00:31:17,542 --> 00:31:23,148 CANDIDATE HERE THAT IS A VACCINE 741 00:31:23,148 --> 00:31:26,118 H107CAF10-B AND CANDIDATE SHOWED 742 00:31:26,118 --> 00:31:28,754 PROMISING PRECLINICAL DATA 743 00:31:28,754 --> 00:31:31,356 HAVING UNIQUE TH1 AND T17 744 00:31:31,356 --> 00:31:36,028 SIGNATURE THAT IS PROTECTIVE IN 745 00:31:36,028 --> 00:31:37,329 PRECLINICAL MODELS AND GATES 746 00:31:37,329 --> 00:31:39,197 FOUNDATION IS CURRENTLY 747 00:31:39,197 --> 00:31:41,300 SUPPORTING PHASE 1 CLINICAL 748 00:31:41,300 --> 00:31:41,667 TRIAL. 749 00:31:41,667 --> 00:31:48,307 AND IT IS ONGOING AS WE SPEAK. 750 00:31:48,307 --> 00:31:50,842 SO SCOPE OF THE NEW FY26 CONCEPT 751 00:31:50,842 --> 00:31:53,312 IS THE FOLLOWING. 752 00:31:53,312 --> 00:31:55,447 AS I SAID, WE HAD A PRIOR 753 00:31:55,447 --> 00:31:58,383 PROGRAM THAT FOCUSED MORE ON THE 754 00:31:58,383 --> 00:32:01,320 DESIGN AND LESS SO ON FURTHER 755 00:32:01,320 --> 00:32:03,088 PRECLINICAL DEVELOPMENT OF 756 00:32:03,088 --> 00:32:03,388 CANDIDATES. 757 00:32:03,388 --> 00:32:06,992 WHAT WE ARE FOCUSING HERE ON IS 758 00:32:06,992 --> 00:32:08,527 PRECLINICAL DEVELOPMENT OF NEW 759 00:32:08,527 --> 00:32:10,629 CANDIDATES, AGAIN, WITH THE GOAL 760 00:32:10,629 --> 00:32:13,699 OF FEEDING THE PHASE I CLINICAL 761 00:32:13,699 --> 00:32:15,567 TRIAL PIPELINE. 762 00:32:15,567 --> 00:32:17,469 ACTIVITIES, WE ANTICIPATE 763 00:32:17,469 --> 00:32:19,905 SUPPORTING OPTIMIZATION OF LEAD 764 00:32:19,905 --> 00:32:23,909 CANDIDATES AND OPTIMIZATION OF 765 00:32:23,909 --> 00:32:25,177 DOSE AND [INDISCERNIBLE] OF 766 00:32:25,177 --> 00:32:27,112 DELIVERY PRECLINICAL AND PRODUCT 767 00:32:27,112 --> 00:32:29,114 DEVELOPMENT ACTIVITIES THAT 768 00:32:29,114 --> 00:32:31,316 INCLUDE SAFETY TOXICITY AND 769 00:32:31,316 --> 00:32:35,687 FURTHER EFFICACY STUDIES. 770 00:32:35,687 --> 00:32:36,455 FURTHERMORE OPTIMIZATION AND 771 00:32:36,455 --> 00:32:38,123 PRODUCTION AND METHODOLOGY AND 772 00:32:38,123 --> 00:32:40,425 PROCESS DEVELOPMENT AND IF 773 00:32:40,425 --> 00:32:42,728 CANDIDATE IS FURTHER DEVELOPED 774 00:32:42,728 --> 00:32:43,562 MANUFACTURING ACTIVITIES ALSO. 775 00:32:43,562 --> 00:32:46,331 THIS PROGRAM, PARTNERSHIP 776 00:32:46,331 --> 00:32:48,467 PROGRAM, DMID PARTNERSHIP 777 00:32:48,467 --> 00:32:50,669 PROGRAM HAS TWO UNIQUE ASPECTS. 778 00:32:50,669 --> 00:32:52,738 ONE OF WHICH IS INDUSTRY 779 00:32:52,738 --> 00:32:56,908 PARTICIPATION IS REQUIRED. 780 00:32:56,908 --> 00:32:58,777 THIS PARTICIPATION COULD BE ON 781 00:32:58,777 --> 00:33:01,179 DIFFERENT LEVELS, CONSULTATION 782 00:33:01,179 --> 00:33:03,348 AND DIRECT DEVELOPMENT OF 783 00:33:03,348 --> 00:33:05,317 INVOLVEMENT AND PHARMACEUTICAL 784 00:33:05,317 --> 00:33:08,520 INDUSTRY BIOTECH OR NON-PROFIT 785 00:33:08,520 --> 00:33:11,089 ORGANIZATION THAT HAS A PROVEN 786 00:33:11,089 --> 00:33:13,325 TRACK RECORD OF VACCINE PRODUCT 787 00:33:13,325 --> 00:33:15,293 DEVELOPMENT AND UNIQUE ASPECT TO 788 00:33:15,293 --> 00:33:17,329 PARTNERSHIP PROGRAM, AS I SAID, 789 00:33:17,329 --> 00:33:21,299 IT IS AN OBJECTIVE DRIVEN R01 790 00:33:21,299 --> 00:33:23,368 MECHANISM BESIDES REGULAR 791 00:33:23,368 --> 00:33:26,338 12-PAGE RESEARCH STRATEGY THAT 792 00:33:26,338 --> 00:33:30,308 YOU FIND IN R0-1 APPLICATIONS 793 00:33:30,308 --> 00:33:32,010 STATES ALSO PRODUCT DEVELOPMENT 794 00:33:32,010 --> 00:33:34,312 STRATEGY SECTION IN ADDITION TO 795 00:33:34,312 --> 00:33:34,746 RESEARCH PLAN. 796 00:33:34,746 --> 00:33:38,884 AND THIS STRATEGY WILL OUTLINE A 797 00:33:38,884 --> 00:33:44,723 PRODUCT DEVELOPMENT PLAN AS WELL 798 00:33:44,723 --> 00:33:47,125 AS TIMELINES AND OBJECTIVES 799 00:33:47,125 --> 00:33:50,262 DESCRIBING ACTIVITIES IN MORE 800 00:33:50,262 --> 00:33:52,197 DETAIL THAN I JUST LISTED HERE. 801 00:33:52,197 --> 00:33:55,400 I WOULD LIKE TO THANK COUNCIL 802 00:33:55,400 --> 00:33:58,837 MEMBERS, DR. TAYLOR AND PALMER 803 00:33:58,837 --> 00:34:01,840 FOR PROVIDING CONSTRUCTIVE 804 00:34:01,840 --> 00:34:04,409 FEEDBACK TO THIS CONCEPT AND 805 00:34:04,409 --> 00:34:06,578 THEY ADDRESS A CRITICAL NEED FOR 806 00:34:06,578 --> 00:34:09,214 VACCINES AND EFFECTIVE NEW TB 807 00:34:09,214 --> 00:34:11,016 VACCINE WOULD NOT ONLY BE A 808 00:34:11,016 --> 00:34:12,984 GREAT ADDITION TO GLOBAL HEALTH 809 00:34:12,984 --> 00:34:15,187 AND SAFEGUARD U.S. CITIZENS AND 810 00:34:15,187 --> 00:34:16,955 QUESTIONS THAT CAME UP DURING 811 00:34:16,955 --> 00:34:20,192 THE DISCUSSION I JUST OUTLINED 812 00:34:20,192 --> 00:34:21,693 IN THE PRESENTATION. 813 00:34:21,693 --> 00:34:24,596 IN CLOSING, AGAIN, THIS CONCEPT 814 00:34:24,596 --> 00:34:25,597 OBJECTIVE HERE OF THIS CONCEPT 815 00:34:25,597 --> 00:34:29,034 IS TO SUPPORT RESEARCH 816 00:34:29,034 --> 00:34:29,601 APPLICATIONS FOR 817 00:34:29,601 --> 00:34:32,037 OBJECTIVE-DRIVEN PROJECTS 818 00:34:32,037 --> 00:34:33,171 FOCUSED ON PRECLINICAL 819 00:34:33,171 --> 00:34:35,574 DEVELOPMENT OF LEAD CANDIDATE 820 00:34:35,574 --> 00:34:37,742 VACCINES PREVENTING TB INFECTION 821 00:34:37,742 --> 00:34:40,779 OR DISEASE INCREASING CLINICAL 822 00:34:40,779 --> 00:34:42,814 PIPELINE OF VIABLE VACCINE 823 00:34:42,814 --> 00:34:45,750 CANDIDATES NEW PROGRAM FOLLOWING 824 00:34:45,750 --> 00:34:48,954 OBJECTIVE DRIVEN R01 MECHANISM 825 00:34:48,954 --> 00:34:49,988 WITH ESTIMATED TOTAL HERE COST 826 00:34:49,988 --> 00:34:56,461 OF 4.7 MILLION DOLLARS BY DMIT 827 00:34:56,461 --> 00:34:58,897 AND DIVISION OF AIDS ANTICIPATE 828 00:34:58,897 --> 00:35:00,732 TO MAKE 3 TO 5 AWARDS. 829 00:35:00,732 --> 00:35:05,303 >> THANK YOU. AGAIN, SINCE 830 00:35:05,303 --> 00:35:07,639 COUNCIL HAS ALREADY SEEN THIS 831 00:35:07,639 --> 00:35:09,307 AND SOME COUNCIL MEMBERS HAVE 832 00:35:09,307 --> 00:35:13,311 SEEN WHAT HAS BEEN INCORPORATED 833 00:35:13,311 --> 00:35:19,451 OPENING UP FOR BROAD ER COUNCIL 834 00:35:19,451 --> 00:35:23,788 FOR COMMENTS AND QUESTIONS. 835 00:35:23,788 --> 00:35:26,558 HEARING NONE, WE WILL MOVE TO 836 00:35:26,558 --> 00:35:30,128 THE LAST CONCEPT FOR REVIEW. 837 00:35:30,128 --> 00:35:32,097 THIS SAY CONCEPT INFLUENCE 838 00:35:32,097 --> 00:35:33,899 TRANSMISSION RESEARCH 839 00:35:33,899 --> 00:35:38,737 CONSORTIUM, P01 ON DR. BROOK 840 00:35:38,737 --> 00:35:40,205 BAZIK FROM RESPIRATORY DISEASE 841 00:35:40,205 --> 00:35:40,672 WILL PRESENT THIS. 842 00:35:40,672 --> 00:35:42,974 >> THANK YOU FOR HAVING ME AND 843 00:35:42,974 --> 00:35:45,010 LIKE JOHN SAID I WILL PRESENT 844 00:35:45,010 --> 00:35:46,444 CONCEPT FOR INFLUENZA 845 00:35:46,444 --> 00:35:50,015 TRANSMISSION RESEARCH 846 00:35:50,015 --> 00:35:50,315 CONSORTIUM. 847 00:35:50,315 --> 00:36:00,058 NEXT SLIDE. 848 00:36:00,058 --> 00:36:02,527 THIS INITIATIVE WILL ESTABLISH 849 00:36:02,527 --> 00:36:03,628 INFLUENZA TRANSMISSION RESEARCH 850 00:36:03,628 --> 00:36:05,330 CONSORT NUMB WITH PROCESS OF 851 00:36:05,330 --> 00:36:08,433 HUMAN TO HUMAN TRANSMISSION AND 852 00:36:08,433 --> 00:36:11,603 PROPOSING P01 MECHANISM WITH 853 00:36:11,603 --> 00:36:14,573 FIRST YEAR AWARDS OF 2 TO 3 AND 854 00:36:14,573 --> 00:36:17,409 OF 8 MILLION DOLLARS. 855 00:36:17,409 --> 00:36:19,477 A LITTLE BACKGROUND ON 856 00:36:19,477 --> 00:36:22,480 TRANSMISSION PROCESS FOR 857 00:36:22,480 --> 00:36:24,249 RESPIRATORY VIRUSES THREE MODES 858 00:36:24,249 --> 00:36:26,051 MAIN CONTACT TRANSMISSION AND 859 00:36:26,051 --> 00:36:29,654 THROUGH LARGE DROPLETS AND 860 00:36:29,654 --> 00:36:32,991 AEROSOL TRANSMISSION. 861 00:36:32,991 --> 00:36:34,526 [INDISCERNIBLE] WITH 862 00:36:34,526 --> 00:36:38,129 CONTAMINATED SURFACES AND 863 00:36:38,129 --> 00:36:39,798 DEPENDING ON SURFACE TYPE 864 00:36:39,798 --> 00:36:42,367 PARTICLES CAN REMAIN INFECTIOUS 865 00:36:42,367 --> 00:36:50,842 FOR UP TO 48 HOURS AND -- LARGE 866 00:36:50,842 --> 00:36:53,945 DROPLETS SETTLE QUICKLY AND 867 00:36:53,945 --> 00:36:55,113 THOUGHTS BE IMPORTANT FOR CLOSE 868 00:36:55,113 --> 00:36:58,316 RANGE TRANSMISSION AND SUSPENDED 869 00:36:58,316 --> 00:37:00,018 NEARLY HOURS TRANSMITTED FAIRLY 870 00:37:00,018 --> 00:37:02,287 LONG DISTANCES AIDED BY 871 00:37:02,287 --> 00:37:04,356 VENTILATION AND AIR FLOW AND 872 00:37:04,356 --> 00:37:07,926 ONGOING DEBATE IN FIELD 873 00:37:07,926 --> 00:37:09,494 APPROPRIATE CUTOFF SIZE LARGE 874 00:37:09,494 --> 00:37:12,263 DROPLETS VERSUS AEROSOLS AND 875 00:37:12,263 --> 00:37:15,834 CUTOFF OF TB DATA IN 1940S AND 876 00:37:15,834 --> 00:37:17,802 RECENT WORK SUGGESTING IT SHOULD 877 00:37:17,802 --> 00:37:20,772 BE HIGHER 30 TO 100 MAKE CONS 878 00:37:20,772 --> 00:37:22,307 AND WHOLE OTHER SCHOOL OF 879 00:37:22,307 --> 00:37:24,142 THOUGHT SAYING PARTICLE SIZE IS 880 00:37:24,142 --> 00:37:26,077 CONTINUUM AND SHOULDN'T BE HUNG 881 00:37:26,077 --> 00:37:30,415 UP ON HOW SIZE EFFECTS AIRBORNE 882 00:37:30,415 --> 00:37:31,616 SUSPENSION BUT THINK WHERE 883 00:37:31,616 --> 00:37:35,654 PARTICLES CAN DEPOSIT IN HOST 884 00:37:35,654 --> 00:37:39,858 AND LARGE DROPLETS IN NASAL 885 00:37:39,858 --> 00:37:42,861 CAVITY AND GO TO LUNGS AND CAUSE 886 00:37:42,861 --> 00:37:43,928 MORE SEVERE DISEASE. 887 00:37:43,928 --> 00:37:44,295 NEXT SLIDE. 888 00:37:44,295 --> 00:37:46,531 IN ADDITION, IN ADDITION TO 889 00:37:46,531 --> 00:37:49,501 VARIOUS MODES OF TRANSMISSION, 890 00:37:49,501 --> 00:37:51,336 THERE ARE HOST VIRAL AND 891 00:37:51,336 --> 00:37:53,905 ENVIRONMENTAL FACTORS 892 00:37:53,905 --> 00:37:56,474 INTERACTIVE TO SUCCESSFUL 893 00:37:56,474 --> 00:37:58,643 TRANSMISSION OCCURS AND 894 00:37:58,643 --> 00:38:01,312 VACCINATION STATUS AGE GENETICS 895 00:38:01,312 --> 00:38:02,914 BEHAVIOR AND INFLUENCE 896 00:38:02,914 --> 00:38:05,316 SUSCEPTIBILITY AND ABILITY TO 897 00:38:05,316 --> 00:38:07,285 SHED VIRUS ENVIRONMENTAL FACTORS 898 00:38:07,285 --> 00:38:09,287 TEMPERATURE AND RELATIVE HUME 899 00:38:09,287 --> 00:38:11,489 TID EFFECT HOW THIS VIRUS CAN 900 00:38:11,489 --> 00:38:13,358 SURVIVE IN ENVIRONMENT AND VIRAL 901 00:38:13,358 --> 00:38:15,326 FACTORS SERVICE PROTEIN AND 902 00:38:15,326 --> 00:38:16,995 MORPH OWE WILLING AND PARTICLE 903 00:38:16,995 --> 00:38:20,699 CAN INFECT A HOST AND TISSUE 904 00:38:20,699 --> 00:38:23,268 TROPHISM AND VIRUS EFFECTS 905 00:38:23,268 --> 00:38:26,604 ANATOMICAL SITE LEADING TO 906 00:38:26,604 --> 00:38:26,938 TRANSMISSION. 907 00:38:26,938 --> 00:38:28,106 NEXT SLIDE. 908 00:38:28,106 --> 00:38:29,574 WITH FRAMEWORK IN MIND WE CAN 909 00:38:29,574 --> 00:38:31,643 START TO MAP MAJOR GAPS IN 910 00:38:31,643 --> 00:38:33,044 KNOWLEDGE OF TRANSITION PROCESS 911 00:38:33,044 --> 00:38:34,846 AND FOR EXAMPLE WE DON'T 912 00:38:34,846 --> 00:38:36,514 UNDERSTAND RELATIVE CONTRIBUTION 913 00:38:36,514 --> 00:38:39,484 OF MODES OF TRANSMISSION IN 914 00:38:39,484 --> 00:38:40,719 DIFFERENT SETTINGS AND 915 00:38:40,719 --> 00:38:43,254 INFECTIOUS VIRUS IS COVERED BY 916 00:38:43,254 --> 00:38:45,390 DROPLETS OR AEROSOLS AND HOST 917 00:38:45,390 --> 00:38:47,592 DRIVEN FACTORS DON'T HAVE 918 00:38:47,592 --> 00:38:49,994 UNDERSTANDING WHETHER 919 00:38:49,994 --> 00:38:52,197 SYMPTOMATIC DISEASE AND HIGH 920 00:38:52,197 --> 00:38:53,631 VIRAL SHEDDING LEAD TO 921 00:38:53,631 --> 00:38:55,467 TRANSMISSION AND PHYSIOLOGICAL 922 00:38:55,467 --> 00:38:59,838 GENETIC AND BEHAVIORAL FACTORS 923 00:38:59,838 --> 00:39:01,206 AND DISPOSE AND EFFECT 924 00:39:01,206 --> 00:39:04,075 TRANSMISSION OF FLU AND 925 00:39:04,075 --> 00:39:05,543 COLONIZATION OR SHEDDING THERE 926 00:39:05,543 --> 00:39:08,446 ARE ENVIRONMENTAL FACTORS 927 00:39:08,446 --> 00:39:10,949 IMPACTING WHERE AND WHEN 928 00:39:10,949 --> 00:39:11,583 TRANSMISSION CAN OCCUR AND GIVEN 929 00:39:11,583 --> 00:39:12,817 SIGNIFICANT GAPS THERE IS NEED 930 00:39:12,817 --> 00:39:15,787 FOR WORK IN THIS AREA AND TUNE 931 00:39:15,787 --> 00:39:18,056 TIME THERE IS INTEREST IN 932 00:39:18,056 --> 00:39:19,824 RESPIRATORY VIRUS TRANSMISSION 933 00:39:19,824 --> 00:39:21,292 IN GENERAL OVER PAST COUPLE 934 00:39:21,292 --> 00:39:24,529 YEARS FOLLOWING EMERGENCE OF 935 00:39:24,529 --> 00:39:27,599 SARS COV-2 AND INFLUENZA STRAT 936 00:39:27,599 --> 00:39:29,567 EEJ PLAINING AND RESEARCH AREA 1 937 00:39:29,567 --> 00:39:33,238 AND OBJECTIVE 1 AND NEXT SLIDE. 938 00:39:33,238 --> 00:39:36,107 THIS IS A RENEWAL OF INITIATIVE 939 00:39:36,107 --> 00:39:38,443 WE PUT FORWARD IN FISCAL YEAR 940 00:39:38,443 --> 00:39:41,079 2021 AND INITIATIVE FACED 941 00:39:41,079 --> 00:39:42,280 SIGNIFICANT CHALLENGES WE 942 00:39:42,280 --> 00:39:44,249 LEARNED FROM. THAT RFA CALLED 943 00:39:44,249 --> 00:39:46,885 FOR BASIC RESEARCH AND FLU 944 00:39:46,885 --> 00:39:48,753 TRANSMISSION BY 945 00:39:48,753 --> 00:39:50,188 MULTI-DISCIPLINARY TEAMS THAT IS 946 00:39:50,188 --> 00:39:51,322 DESCRIPTIVE REQUIRING PROGRAMS 947 00:39:51,322 --> 00:39:55,593 TO PROPOSE DEVELOPMENT OF DEVICE 948 00:39:55,593 --> 00:39:57,862 FOR SAMPLING AIRBORNE PARTICLES 949 00:39:57,862 --> 00:40:00,665 AND NOVEL ASSAY VIABILITY OF 950 00:40:00,665 --> 00:40:02,700 PARTICLES IN ADDITION TO 951 00:40:02,700 --> 00:40:04,102 PERFORMING COMPREHENSIVE 952 00:40:04,102 --> 00:40:07,005 RESEARCH PROJECTS FINDING BIT OF 953 00:40:07,005 --> 00:40:07,639 DISCONNECT BETWEEN STATE OF 954 00:40:07,639 --> 00:40:10,041 SCIENCE AND RFA REQUIREMENTS 955 00:40:10,041 --> 00:40:11,676 SPECIFICALLY REGARDING 956 00:40:11,676 --> 00:40:13,311 TECHNOLOGY DEVELOPMENT AND 957 00:40:13,311 --> 00:40:14,746 TIMELINES FINDING A MAJOR 958 00:40:14,746 --> 00:40:17,182 CHALLENGE TO DEVELOP INNOVATIVE 959 00:40:17,182 --> 00:40:19,517 DEVICES AND ASSAYS INTEGRATING 960 00:40:19,517 --> 00:40:21,686 THEM IN RESEARCH IN FIVE YEARS 961 00:40:21,686 --> 00:40:23,421 ESPECIALLY IF TECHNOLOGY IS 962 00:40:23,421 --> 00:40:25,757 NOVEL AND NO PROTOTYPES 963 00:40:25,757 --> 00:40:27,492 DEVELOPED AND MAJOR CHALLENGE NO 964 00:40:27,492 --> 00:40:29,460 ONE COULD HAVE FORESEEN IS RFA 965 00:40:29,460 --> 00:40:32,096 WAS PUBLISHED AND AWARDED DURING 966 00:40:32,096 --> 00:40:36,267 HEIGHT OF COVID PANDEMIC LED TO 967 00:40:36,267 --> 00:40:39,003 HURDLES FOR ANY AWARD AT THAT 968 00:40:39,003 --> 00:40:40,572 TIME AND WASN'T FLU SEASON FOR 969 00:40:40,572 --> 00:40:43,208 FIRST TWO YEARS FOLLOWING 970 00:40:43,208 --> 00:40:46,010 OUTBREAK. FROM 2020 TO 2022 971 00:40:46,010 --> 00:40:47,378 THERE WASN'T FLU CIRCULATION AND 972 00:40:47,378 --> 00:40:50,281 FINALLY SINCE RFA WENT OUT IN 973 00:40:50,281 --> 00:40:53,351 MIDDLE OF PANDEMIC CAUSE FROM 974 00:40:53,351 --> 00:40:56,221 COMMUNITY AT TIME INCORPORATING 975 00:40:56,221 --> 00:40:58,690 SARS COV2 AT CENTERS AND AT THIS 976 00:40:58,690 --> 00:41:00,825 TIME AND KNEW THERE WASN'T GOING 977 00:41:00,825 --> 00:41:02,760 TO BE FLU SEASON DIDN'T WANT 978 00:41:02,760 --> 00:41:06,364 COVID TO SWAMP OUT FLU WORK. 979 00:41:06,364 --> 00:41:07,599 NEXT SLIDE. 980 00:41:07,599 --> 00:41:08,466 TAKING LESSONS INTO 981 00:41:08,466 --> 00:41:10,101 CONSIDERATION WHEN DESIGNING NEW 982 00:41:10,101 --> 00:41:15,240 INITIATIVE PROPOSING P01 FOR 983 00:41:15,240 --> 00:41:18,076 RENEWAL AND ACCOMMODATING 984 00:41:18,076 --> 00:41:18,710 COMPREHENSIVE STUDIES AND 985 00:41:18,710 --> 00:41:20,178 RESOURCE DEVELOPMENT THAT WILL 986 00:41:20,178 --> 00:41:22,280 BE REQUIRED REQUIRING CENTERS TO 987 00:41:22,280 --> 00:41:24,115 INCLUDE 2 AND NO MORE THAN THREE 988 00:41:24,115 --> 00:41:27,085 RESEARCH PROJECTS ADMINISTRATIVE 989 00:41:27,085 --> 00:41:29,587 CORE AND THIS TIME AROUND 990 00:41:29,587 --> 00:41:31,589 RESOURCE CORE TO DEVELOP TOOLS 991 00:41:31,589 --> 00:41:33,191 FOR COMMUNITY TO INVESTIGATE 992 00:41:33,191 --> 00:41:34,525 TRANSMISSION AND WILL BE 993 00:41:34,525 --> 00:41:37,929 FLEXIBLE TO ALLOW TEAMS TO 994 00:41:37,929 --> 00:41:39,464 PROPOSE DEVELOPMENT OF RESOURCE 995 00:41:39,464 --> 00:41:41,165 WITHIN SPECIFIC STRENGTHS AND 996 00:41:41,165 --> 00:41:42,533 EXPERTISE AND INCLUDE DEVICES 997 00:41:42,533 --> 00:41:45,603 AND ASSAYS OR BE NEW LIKE ANIMAL 998 00:41:45,603 --> 00:41:48,539 MODELS AND EXPERIMENTAL SETUP 999 00:41:48,539 --> 00:41:50,408 AND COMPUTATIONAL MODELS AND 1000 00:41:50,408 --> 00:41:52,710 IMPROVEMENTS TO EXISTING 1001 00:41:52,710 --> 00:41:55,747 RESOURCES WOULD BE ALLOWED AND 1002 00:41:55,747 --> 00:41:58,049 IMPROVE 789S MORE INCREMENTAL 1003 00:41:58,049 --> 00:41:59,484 AND OTHERS COULD BE INCLUDED 1004 00:41:59,484 --> 00:42:02,553 BASED ON THAT SPECIFIC CENTER'S 1005 00:42:02,553 --> 00:42:04,756 NEEDS AND INTERESTS AND 1006 00:42:04,756 --> 00:42:06,557 PATHOGENS LIKE FLU WE ALLOW 1007 00:42:06,557 --> 00:42:08,159 CENTERS TO CONDUCT COMPARATIVE 1008 00:42:08,159 --> 00:42:10,929 STUDIES WITH HUMAN SEASONAL 1009 00:42:10,929 --> 00:42:12,030 RESPIRATORY PATHOGENS SO LONG AS 1010 00:42:12,030 --> 00:42:14,565 CENTER STAYS ON FLU AND WANT 1011 00:42:14,565 --> 00:42:16,534 PROGRAM TO FUNCTION AS 1012 00:42:16,534 --> 00:42:17,669 COLLABORATIVE NETWORK PROPOSING 1013 00:42:17,669 --> 00:42:20,905 BUILDING IN CAVEATS TO RFA AND 1014 00:42:20,905 --> 00:42:24,742 MEETINGS AND WEBINARS TO SHARE 1015 00:42:24,742 --> 00:42:25,476 FINDINGS AND WORKING GROUPS WITH 1016 00:42:25,476 --> 00:42:28,012 TOPICS BASED ON THEMES THAT 1017 00:42:28,012 --> 00:42:31,582 CENTERS ARE AWARDED. NEXT 1018 00:42:31,582 --> 00:42:31,883 SLIDE. 1019 00:42:31,883 --> 00:42:34,686 SCOPE OF INITIATIVE WOULD BE 1020 00:42:34,686 --> 00:42:36,721 LIMITED TO INFLUENZA AND 1021 00:42:36,721 --> 00:42:41,159 SEASONAL HUMAN RESPIRATORY 1022 00:42:41,159 --> 00:42:41,426 VIRUSES. 1023 00:42:41,426 --> 00:42:43,127 IMPORTANTLY PROGRAMS NEED TO 1024 00:42:43,127 --> 00:42:45,330 FOCUS ON HUMAN TO HUMAN 1025 00:42:45,330 --> 00:42:48,967 TRANSMISSION OF FLU AND ANIMAL 1026 00:42:48,967 --> 00:42:50,234 MODELS RECAPITULATE THIS SCOPE 1027 00:42:50,234 --> 00:42:51,669 AND [INDISCERNIBLE] ANIMAL HUMAN 1028 00:42:51,669 --> 00:42:53,638 INTERFACE AND FOR PROGRAMS GOAL 1029 00:42:53,638 --> 00:42:55,940 IS TO UNDERSTAND DYNAMICS AND 1030 00:42:55,940 --> 00:42:57,342 DRIVERS OF FLU TRANSMISSIONS 1031 00:42:57,342 --> 00:42:58,776 WHILE LOOKING AT THINGS LIKE 1032 00:42:58,776 --> 00:43:00,244 PREVENTION STRATEGIES WOULD BE 1033 00:43:00,244 --> 00:43:02,880 ALLOWED WE DON'T WANT FOCUS OF 1034 00:43:02,880 --> 00:43:05,183 CENTERS TO BE ON DESIGN, 1035 00:43:05,183 --> 00:43:06,451 IMPLEMENTATION OR PRODUCT 1036 00:43:06,451 --> 00:43:08,619 DEVELOPMENT AND WITH RFA WE ARE 1037 00:43:08,619 --> 00:43:09,387 TRYING TO UNDERSTAND 1038 00:43:09,387 --> 00:43:10,455 TRANSMISSION BEFORE WE ATTEMPT 1039 00:43:10,455 --> 00:43:11,356 TO STOP IT. 1040 00:43:11,356 --> 00:43:14,058 WE RECOGNIZE THAT BEHAVIORAL 1041 00:43:14,058 --> 00:43:16,227 INTERVENTIONS COULD BE A USEFUL 1042 00:43:16,227 --> 00:43:17,829 TOOL FOR STUDYING TRANSMISSION 1043 00:43:17,829 --> 00:43:21,099 IN DIFFERENT SETTINGS RFA 1044 00:43:21,099 --> 00:43:23,067 ALLOWING CLINICAL TRIALS 1045 00:43:23,067 --> 00:43:24,068 PHARMACEUTICAL INTERVENTIONS NO 1046 00:43:24,068 --> 00:43:26,070 CLINICAL TRIALS INVOLVING 1047 00:43:26,070 --> 00:43:28,373 PHARMACEUTICALS VACCINES 1048 00:43:28,373 --> 00:43:30,074 THERAPEUTICS BIOLOGICS . 1049 00:43:30,074 --> 00:43:30,842 NEXT SLIDE 1050 00:43:30,842 --> 00:43:33,044 WE WOULD LIKE TO THANK COUNCIL 1051 00:43:33,044 --> 00:43:34,812 MEMBERS FOR REVIEWING THIS 1052 00:43:34,812 --> 00:43:36,481 CONCEPT AND PROVIDING FEEDBACK 1053 00:43:36,481 --> 00:43:38,316 AND BOTH THOUGHT IT WAS A HIGH 1054 00:43:38,316 --> 00:43:40,118 PRIORITY AREA OF RESEARCH 1055 00:43:40,118 --> 00:43:43,588 THINKING IT WOULD BE IMPORTANT 1056 00:43:43,588 --> 00:43:46,457 TO ASSEMBLE MULTI-DISCIPLINARY 1057 00:43:46,457 --> 00:43:47,358 TEAMS TO ACCOMPLISH GOALS THAT 1058 00:43:47,358 --> 00:43:50,061 THEY RECOMMENDED CLARIFYING HERE 1059 00:43:50,061 --> 00:43:53,831 INITIATIVE STRUCTURED AS P01 IS 1060 00:43:53,831 --> 00:43:54,499 SEPARATE OPPORTUNITY AS PARENT 1061 00:43:54,499 --> 00:43:57,335 R0 ONE WITH REQUIREMENTS 1062 00:43:57,335 --> 00:43:59,437 DEDICATED REVIEW AND SET ASIDE 1063 00:43:59,437 --> 00:43:59,937 FUNDS. 1064 00:43:59,937 --> 00:44:00,738 NEXT SLIDE. 1065 00:44:00,738 --> 00:44:02,273 WITH THAT THANKS FOR THE CHANCE 1066 00:44:02,273 --> 00:44:03,741 TO PRESENT THIS CONCEPT AND 1067 00:44:03,741 --> 00:44:06,778 HAPPY TO TAKE ANY QUESTIONS. 1068 00:44:06,778 --> 00:44:08,679 >> THANK YOU, BURT. ANY 1069 00:44:08,679 --> 00:44:10,448 QUESTIONS ON CONCEPT OF 1070 00:44:10,448 --> 00:44:13,584 INFLUENCE AND TRANSMISSION 1071 00:44:13,584 --> 00:44:16,754 RESEARCH CONSORTIUM? 1072 00:44:16,754 --> 00:44:20,591 ALL RIGHT. WHAT YOU HEARD IS WE 1073 00:44:20,591 --> 00:44:22,994 HAVE FOUR HIGH PRIORITY CONCEPTS 1074 00:44:22,994 --> 00:44:24,295 WE THINK ARE SIGNIFICANT AND 1075 00:44:24,295 --> 00:44:26,264 SIGNIFICANT POTENTIAL TO ADVANCE 1076 00:44:26,264 --> 00:44:29,233 THE FIELD AND SUPPORT THE FIELD. 1077 00:44:29,233 --> 00:44:31,602 AND AT THIS TIME, IF WILL IS NO 1078 00:44:31,602 --> 00:44:33,171 FURTHER QUESTIONS ON ANY OF 1079 00:44:33,171 --> 00:44:36,140 THOSE, WE WOULD ASK THAT THE 1080 00:44:36,140 --> 00:44:41,345 COUNCIL VOTE IN THEIR ELECTRONIC 1081 00:44:41,345 --> 00:44:47,218 COUNCIL BOOK. 1082 00:44:47,218 --> 00:44:49,921 NOW DEFERRING TO DEA COLLEAGUES 1083 00:44:49,921 --> 00:44:51,556 TO MONITOR PROGRESS THERE. 1084 00:44:51,556 --> 00:44:53,324 >> THANK YOU. WE ARE MONITORING 1085 00:44:53,324 --> 00:44:55,259 AND VOTES ARE COMING IN AND GIVE 1086 00:44:55,259 --> 00:45:00,264 US A FEW MINUTES WHILE COUNCIL 1087 00:45:00,264 --> 00:45:10,541 MEMBERS VOTE. 1088 00:46:26,450 --> 00:46:31,622 DR. ESTEZ AND PEEBLES WE ARE 1089 00:46:31,622 --> 00:46:33,591 MISSING YOUR VOTES. ARE YOU 1090 00:46:33,591 --> 00:46:34,492 VOTING OKAY? 1091 00:46:34,492 --> 00:46:36,027 >> I THOUGHT I VOTED. 1092 00:46:36,027 --> 00:46:38,262 >> I GOT KICKED OUT AND HAVEN'T 1093 00:46:38,262 --> 00:46:39,397 LOGGED BACK IN. SORRY. 1094 00:46:39,397 --> 00:46:41,199 >> I MIGHT HAVE TO LOG BACK IN 1095 00:46:41,199 --> 00:46:41,399 TOO. 1096 00:46:41,399 --> 00:46:43,701 >> THAT IS OKAY. SOMETIMES THE 1097 00:46:43,701 --> 00:46:48,372 SYSTEM DOES KICK YOU OUT. IT 1098 00:46:48,372 --> 00:46:58,583 TIMES OUT. 1099 00:47:37,388 --> 00:47:39,123 >> YOU SHOULD HAVE MY VOTE. 1100 00:47:39,123 --> 00:47:43,661 >> THANK YOU. WE HAVE THEM ALL 1101 00:47:43,661 --> 00:47:46,631 NOW. DR. TAUBEN BERGER, WE CAN 1102 00:47:46,631 --> 00:47:47,965 PULL YOUR SLIDES UP AND PROCEED 1103 00:47:47,965 --> 00:47:49,033 WITH THE END, THANK YOU. 1104 00:47:49,033 --> 00:47:51,936 >> THANK YOU SO MUCH. THANK YOU 1105 00:47:51,936 --> 00:47:56,507 JOHN AND DMID COLLEAGUES FOR 1106 00:47:56,507 --> 00:47:59,844 PRESENTING CONCEPTS AND GRATEFUL 1107 00:47:59,844 --> 00:48:01,112 TO THE COUNCIL FOR CONSIDERATION 1108 00:48:01,112 --> 00:48:02,980 OF THE CONCEPTS BEFORE WE 1109 00:48:02,980 --> 00:48:05,716 PROCEED TO NEXT TWO ITEMS ON 1110 00:48:05,716 --> 00:48:08,152 AGENDA WE HAVE RECEIVED A 1111 00:48:08,152 --> 00:48:10,588 WRITTEN COMMENT FROM JESSICA AND 1112 00:48:10,588 --> 00:48:12,857 JARED WITH PHYSICIANS COMMITTEE 1113 00:48:12,857 --> 00:48:14,558 OF FULL RESPONSIBLE MEDICINE AND 1114 00:48:14,558 --> 00:48:15,926 COMMENT INCLUDES RECOMMENDATIONS 1115 00:48:15,926 --> 00:48:16,961 THAT INSTITUTE PRIORITIZE 1116 00:48:16,961 --> 00:48:23,834 DEVELOPMENT AND USE OF 1117 00:48:23,834 --> 00:48:24,835 HUMAN-BASED -- FULL COMMENT WILL 1118 00:48:24,835 --> 00:48:27,238 BE INCLUDED IN THE ELECTRONIC 1119 00:48:27,238 --> 00:48:30,875 COUNCIL BOOK AND COUNCIL 1120 00:48:30,875 --> 00:48:31,409 MINUTES. 1121 00:48:31,409 --> 00:48:33,077 SO OUR NEXT COUNCIL MEETING IS 1122 00:48:33,077 --> 00:48:35,146 PLANNED FOR SEPTEMBER AND WILL 1123 00:48:35,146 --> 00:48:37,014 INCLUDE OPENED AND CLOSED 1124 00:48:37,014 --> 00:48:39,717 SESSION AS HHS AND NIH POLICIES 1125 00:48:39,717 --> 00:48:40,685 PERMIT AND ADDITIONAL 1126 00:48:40,685 --> 00:48:42,219 INFORMATION ABOUT THE MEETING 1127 00:48:42,219 --> 00:48:45,690 WILL BE PROVIDED SHORTLY. 1128 00:48:45,690 --> 00:48:50,761 NEXT SLIDE, PLEASE. 1129 00:48:50,761 --> 00:48:52,730 SO AT THIS POINT I WOULD LIKE 1130 00:48:52,730 --> 00:48:54,432 TO, AGAIN, THANK COUNCIL MEMBERS 1131 00:48:54,432 --> 00:48:55,966 FOR PARTICIPATING IN THE OPEN 1132 00:48:55,966 --> 00:48:57,168 SESSION OF THE COUNCIL AND PLAN 1133 00:48:57,168 --> 00:48:59,370 TO SEE ALL OF YOU WHEN WE 1134 00:48:59,370 --> 00:49:05,242 RECONVENE IN SEPTEMBER AND I'M 1135 00:49:05,242 --> 00:49:06,777 ADJOURNING THIS COUNCIL MEETING 1136 00:49:06,777 --> 00:49:10,481 AT THIS TIME. THANK YOU SO 1137 00:49:10,481 --> 00:49:10,815 MUCH. 1138 00:49:10,815 --> 00:49:21,058 >> THANK YOU.