1
00:00:05,195 --> 00:00:07,998
SO THANK YOU AND WELCOME TO 

2
00:00:07,998 --> 00:00:14,004
THE OPEN DIVISION OF THE 

3
00:00:14,004 --> 00:00:17,908
DIVISION OF MICROBIOLOGY AND 

4
00:00:17,908 --> 00:00:19,242
INFECTIOUS DISEASE SUBCOMMITTEE 

5
00:00:19,242 --> 00:00:19,476
COUNCIL.

6
00:00:19,476 --> 00:00:21,378
THE AGENDA FOR THIS AFTERNOON IS

7
00:00:21,378 --> 00:00:21,912
ON THIS SLIDE.

8
00:00:21,912 --> 00:00:24,881
I'M GOING TO GIVE A BRIEF REPORT

9
00:00:24,881 --> 00:00:28,518
WITH A PERSONNEL UPDATE AS WELL 

10
00:00:28,518 --> 00:00:33,657
AS A FEW HIGHLIGHTS OF OUR 

11
00:00:33,657 --> 00:00:34,991
RESEARCH NEWS AND THINGS 

12
00:00:34,991 --> 00:00:37,928
ANNOUNCED SINCE WE LAST MET.

13
00:00:37,928 --> 00:00:39,930
WE HAVE A NUMBER OF DMID 

14
00:00:39,930 --> 00:00:41,465
CONCEPTS FOR APPROVAL.

15
00:00:41,465 --> 00:00:42,699
SIX OF THEM.

16
00:00:42,699 --> 00:00:44,100
LAST WE HAVE A CONCEPT FROM ONE 

17
00:00:44,100 --> 00:00:46,002
OF OUR SISTER DIVISIONS THE 

18
00:00:46,002 --> 00:00:48,071
DIVISION OF CLINICAL RESEARCH.

19
00:00:48,071 --> 00:00:53,043
WE HAVE A PRESENTATION ON THE 

20
00:00:53,043 --> 00:00:56,446
CONTRACT CONCEPT FOR THAT 

21
00:00:56,446 --> 00:00:56,713
DIVISION.

22
00:00:56,713 --> 00:00:59,216
SO, FIRST I WANTED TO INTRODUCE 

23
00:00:59,216 --> 00:01:02,953
SOME NEW STAFF.

24
00:01:02,953 --> 00:01:07,791
I'LL INTRODUCE THEM VIRTUALLY AT

25
00:01:07,791 --> 00:01:07,991
LEAST.

26
00:01:07,991 --> 00:01:17,667
DR. GENEVIEVE HOLZAPEL IN THE 

27
00:01:17,667 --> 00:01:20,103
VIROLOGY BRANCH AND A NEW 

28
00:01:20,103 --> 00:01:21,805
PROGRAM OF COOPERATIVE 

29
00:01:21,805 --> 00:01:22,906
AGREEMENTS THAT WILL FOCUS ON 

30
00:01:22,906 --> 00:01:25,075
VIRAL FAMILIES THAT HAVE 

31
00:01:25,075 --> 00:01:28,545
PANDEMIC POTENTIAL ON DEVELOPING

32
00:01:28,545 --> 00:01:29,813
VACCINES AND MONOCLONAL 

33
00:01:29,813 --> 00:01:30,313
ANTIBODIES.

34
00:01:30,313 --> 00:01:32,582
SHE CAME FROM GSK VACCINES 

35
00:01:32,582 --> 00:01:34,551
FOCUSSING ON PRE-CLINICAL 

36
00:01:34,551 --> 00:01:35,952
VACCINE DISCOVERY.

37
00:01:35,952 --> 00:01:40,824
AND THEN ANNIE BRIDWELL FROM THE

38
00:01:40,824 --> 00:01:42,792
VIROLOGY BRANCH WORKING ON THE 

39
00:01:42,792 --> 00:01:44,895
REVAMP PROGRAM AS WELL.

40
00:01:44,895 --> 00:01:45,829
SHE WAS IN THE THERAPEUTIC 

41
00:01:45,829 --> 00:01:47,364
RESEARCH PROGRAM IN THE DIVISION

42
00:01:47,364 --> 00:01:50,367
OF AIDS RESPONSIBLE FOR TB 

43
00:01:50,367 --> 00:01:52,168
FOCUSSED PORTFOLIO ON ANIMAL 

44
00:01:52,168 --> 00:01:52,802
MODELS AND PRE CLINICAL DIRECT 

45
00:01:52,802 --> 00:01:59,743
DEVELOPMENT.

46
00:01:59,743 --> 00:02:09,119
SHUSHMA BHLOSE WILL OVERSEE THE 

47
00:02:09,119 --> 00:02:12,222
HEPATITIS PORTFOLIO.

48
00:02:12,222 --> 00:02:15,659
SHE WAS AN ASSOCIATE STUDY 

49
00:02:15,659 --> 00:02:20,096
DIRECTOR AND LED THE DEVELOPMENT

50
00:02:20,096 --> 00:02:21,031
OF MICROPHYSIOLOGIC SYSTEMS AT 

51
00:02:21,031 --> 00:02:22,599
THE HIGH CONTAINMENT LABORATORY 

52
00:02:22,599 --> 00:02:24,401
AT IRF.

53
00:02:24,401 --> 00:02:29,673
SO THAT'S A BSL4 LAB IN 

54
00:02:29,673 --> 00:02:32,676
FREDERICK THAT COUNTER MEASURES 

55
00:02:32,676 --> 00:02:34,945
AGAINST HIGH-RISK VIRUSES.

56
00:02:34,945 --> 00:02:45,388
AND FEORILLO GALIVO WAS A 

57
00:02:46,656 --> 00:02:48,858
PHARMACOLOGY AND TOXICOLOGY 

58
00:02:48,858 --> 00:02:51,161
REVIEWER AND TEAM LEAD AND WAS 

59
00:02:51,161 --> 00:02:53,830
FOCUSSED ON CELL AND GENE 

60
00:02:53,830 --> 00:02:55,131
THERAPY THERAPEUTICS FOR 

61
00:02:55,131 --> 00:02:56,666
ONCOLOGY AND NON-ONCOLOGY 

62
00:02:56,666 --> 00:02:58,168
INDICATIONS.

63
00:02:58,168 --> 00:03:01,104
WELCOME TO THE VIROLOGY PROGRAM 

64
00:03:01,104 --> 00:03:03,840
OFFICERS.

65
00:03:03,840 --> 00:03:14,384
WE ALSO WELCOME GEORGE JORGE 

66
00:03:20,123 --> 00:03:21,124
MEJIA-GALVIS.

67
00:03:21,124 --> 00:03:22,826
HE'S HAD SEVERAL ROLES IN HIS 

68
00:03:22,826 --> 00:03:25,362
CAREER IN CLINICAL TRIAL WORK 

69
00:03:25,362 --> 00:03:28,465
AND DATA MANAGEMENT AND HE WAS A

70
00:03:28,465 --> 00:03:29,299
MEDICAL MONITOR WORKING WITH ONE

71
00:03:29,299 --> 00:03:39,643
OF OUR CONTRACTORS.

72
00:03:40,610 --> 00:03:46,583
DR. YUNUS ABDUL COMES TO US FROM

73
00:03:46,583 --> 00:03:49,653
THE ASPR IN ANOTHER HHS AGENCY 

74
00:03:49,653 --> 00:03:52,255
WHERE HE SUPPORTED 

75
00:03:52,255 --> 00:03:54,691
COMMERCIALIZATION OF COVID-19 

76
00:03:54,691 --> 00:03:57,093
ANTIVIRALS AND VACCINES 

77
00:03:57,093 --> 00:03:57,661
DEVELOPED IN OPERATION WARP 

78
00:03:57,661 --> 00:04:05,635
SPEED.

79
00:04:05,635 --> 00:04:06,369
A LITTLE BIT OF RESEARCH NEWS 

80
00:04:06,369 --> 00:04:07,437
FROM PROGRAMS WE SUPPORTED.

81
00:04:07,437 --> 00:04:11,875
THERE WAS AN ANNOUNCEMENT LAST 

82
00:04:11,875 --> 00:04:17,113
MONTH PUBLISHED IN THE JOURNAL 

83
00:04:17,113 --> 00:04:25,121
OF VACCINES THAT AN LASSA FEVER 

84
00:04:25,121 --> 00:04:31,127
VIRUS VACCINE PROTECTED NONHUMAN

85
00:04:31,127 --> 00:04:34,431
PRIMATES FROM LETHAL DISEASE AND

86
00:04:34,431 --> 00:04:38,168
IT'S BEEN PRIMARILY IN WEST 

87
00:04:38,168 --> 00:04:39,469
AFRICA IN THE BIOLOGIC THREAT 

88
00:04:39,469 --> 00:04:40,570
LIST AND THERE'S NO VACCINE 

89
00:04:40,570 --> 00:04:44,808
AVAILABLE BUT IS A HIGH PRIORITY

90
00:04:44,808 --> 00:04:55,118
FOR PUBLIC HEALTH.

91
00:05:06,296 --> 00:05:09,866
NON HUMAN PRIMATES WERE GIVEN 

92
00:05:09,866 --> 00:05:11,067
THIS IN A PROJECT AND WE WERE 

93
00:05:11,067 --> 00:05:14,771
PLEASED WITH THE SUCCESS OF THE 

94
00:05:14,771 --> 00:05:15,004
PROJECT.

95
00:05:15,004 --> 00:05:15,705
YOU HEARD WE WERE FUNDING A 

96
00:05:15,705 --> 00:05:21,111
NUMBER OF NEW PROJECTS IN 

97
00:05:21,111 --> 00:05:22,312
SYPHILIS DIAGNOSTICS.

98
00:05:22,312 --> 00:05:25,181
IF YOU HAVE DIAGNOSED PATIENTS 

99
00:05:25,181 --> 00:05:26,616
AND FOLLOWED THE DIAGNOSTICS ARE

100
00:05:26,616 --> 00:05:28,351
TERRIBLE AND MORE THAN 50 YEARS 

101
00:05:28,351 --> 00:05:35,458
OLD AND HAVEN'T EVOLVED.

102
00:05:35,458 --> 00:05:38,661
THE AWARD FOR NEW TECHNOLOGIES 

103
00:05:38,661 --> 00:05:40,463
THAT WILL LEAD TO BETTER 

104
00:05:40,463 --> 00:05:42,031
PROCESSING IN CLINICAL SAMPLES 

105
00:05:42,031 --> 00:05:44,334
SO THERE'S SMALL AMOUNTS OF 

106
00:05:44,334 --> 00:05:48,204
NUCLEIC ACIDS CAN BE DETECTS.

107
00:05:48,204 --> 00:05:50,940
SOME FOCUS ON SPECIFIC 

108
00:05:50,940 --> 00:05:52,675
SUBCLASSES OF ANTIBODIES THAT 

109
00:05:52,675 --> 00:05:58,314
MAY BE GOOD DIAGNOSTIC TESTS.

110
00:05:58,314 --> 00:06:00,483
SOME FOCUS ON A GENERAL OMICS 

111
00:06:00,483 --> 00:06:01,117
APPROACH HOSTING THE 

112
00:06:01,117 --> 00:06:09,125
REPRESENTATION.

113
00:06:09,125 --> 00:06:11,795
SOME FOCUS ON CONGENITAL FOCUS 

114
00:06:11,795 --> 00:06:13,129
AND WE'RE HOPEFUL IT WILL MOVE 

115
00:06:13,129 --> 00:06:20,837
FORWARD WITH THE NEW PORTFOLIO.

116
00:06:20,837 --> 00:06:21,905
THEN ANOTHER RECENT CLINICAL 

117
00:06:21,905 --> 00:06:28,444
TRIAL LAUNCHED YOU MIGHT RECALL 

118
00:06:28,444 --> 00:06:30,246
OVER THE PAST 10 YEARS AT LEAST 

119
00:06:30,246 --> 00:06:36,352
STARTING IN 2014 AND WHY EVERY 

120
00:06:36,352 --> 00:06:39,956
OTHER YEAR NEW OUTBREAKS OF 

121
00:06:39,956 --> 00:06:45,695
ACUTE FLACCID MYELITIS CASES 

122
00:06:45,695 --> 00:06:48,464
USUALLY YOUNG CHILDREN, TODDLERS

123
00:06:48,464 --> 00:06:50,066
PRESENTING WITH PARALYSIS, ONE 

124
00:06:50,066 --> 00:06:54,838
ARM OR ONE LEG OR MORE THAN THAT

125
00:06:54,838 --> 00:06:57,106
WITH SOME DOUBT THE PARALYSIS 

126
00:06:57,106 --> 00:07:01,110
INVOLVED UPPER MOTOR NEURONS OR 

127
00:07:01,110 --> 00:07:03,346
THE CRANIAL NERVES WHICH WAS 

128
00:07:03,346 --> 00:07:06,850
ALSO A FEATURE IN SOME CASES.

129
00:07:06,850 --> 00:07:10,553
SO THIS WAS OBVIOUSLY A TERRIBLE

130
00:07:10,553 --> 00:07:13,122
PROBLEM FOR THESE YOUNG PEOPLE.

131
00:07:13,122 --> 00:07:16,960
WE STARTED TO WORK ON POTENTIAL 

132
00:07:16,960 --> 00:07:24,767
COUNTER MEASURES FOR THIS FOR 

133
00:07:24,767 --> 00:07:29,472
EBD6A THE AGENT CAUSING THE 

134
00:07:29,472 --> 00:07:31,574
PARALYSIS.

135
00:07:31,574 --> 00:07:35,144
-- EV-D68 AND WE WERE ABLE TO 

136
00:07:35,144 --> 00:07:39,349
DEVELOP A MONOCLONAL ANTIBODY 

137
00:07:39,349 --> 00:07:43,052
AND A PROCESS TO CREATE IT IN 

138
00:07:43,052 --> 00:07:44,687
GENETICALLY MODIFIED PLANT AND 

139
00:07:44,687 --> 00:07:46,489
MAKE SUFFICIENT ANTIBODY THAT 

140
00:07:46,489 --> 00:07:47,824
COULD BE USED IN CLINICAL 

141
00:07:47,824 --> 00:07:48,057
TRIALS.

142
00:07:48,057 --> 00:07:53,196
THEY STARTED IN THE PAST FEW 

143
00:07:53,196 --> 00:08:03,573
MONTHS AT VANDERBILT.

144
00:08:07,877 --> 00:08:09,879
SOME HOPING SOME MUSCLE FUNCTION

145
00:08:09,879 --> 00:08:11,915
CAN BE RESTORED IN THE CASE OF 

146
00:08:11,915 --> 00:08:13,349
THE ANIMAL OF THE EXPERIMENTS IN

147
00:08:13,349 --> 00:08:15,585
THE LAB GET THE MONOCLONAL 

148
00:08:15,585 --> 00:08:17,787
ANTIBODY INJECTED EVEN AFTER 

149
00:08:17,787 --> 00:08:20,023
THEY'VE BEEN PARALYZED A SHORT 

150
00:08:20,023 --> 00:08:20,623
PERIOD OF TIME.

151
00:08:20,623 --> 00:08:22,558
THE BELIEF OR HOPE IS THAT SOME 

152
00:08:22,558 --> 00:08:25,061
DAY THIS COULD BE AN EFFECTIVE 

153
00:08:25,061 --> 00:08:26,963
COUNTER MACHINE USED CLINICALLY.

154
00:08:26,963 --> 00:08:30,033
THE FIRST STEP IS TO DO A 

155
00:08:30,033 --> 00:08:32,302
CLINICAL TRIAL THAT SHOWS IT'S 

156
00:08:32,302 --> 00:08:36,272
PK AND PD DISTRIBUTION AND 

157
00:08:36,272 --> 00:08:37,573
SAFETY IN ADULTS.

158
00:08:37,573 --> 00:08:39,542
YOU'LL NOTICE THIS WAS A BIG 

159
00:08:39,542 --> 00:08:41,144
PROBLEM UP UNTIL 2018 AND THEN 

160
00:08:41,144 --> 00:08:42,512
WITH THE PANDEMIC THE CASES WENT

161
00:08:42,512 --> 00:08:52,822
DOWN DRAMATICALLY.

162
00:08:59,162 --> 00:09:01,497
 YOU DEVELOP THIS AND THEN IT 

163
00:09:01,497 --> 00:09:03,766
GOES AWAY BUT WE HAVE A TRIAL IN

164
00:09:03,766 --> 00:09:14,210
CASE THE OUTBREAKS RECUR.

165
00:09:32,628 --> 00:09:36,499
AND WE'LL HAVE AMIR ZEITUNI TO 

166
00:09:36,499 --> 00:09:46,642
PRESENT.

167
00:10:01,758 --> 00:10:01,958
THIS 

168
00:10:01,958 --> 00:10:05,395
>> THANK YOU FOR ALLOWING
ME TO 

169
00:10:05,395 --> 00:10:07,530
PRESENT THE BROAD SPECTRUM 

170
00:10:07,530 --> 00:10:11,401
PRODUCTS AGAINST MULTIPLE 

171
00:10:11,401 --> 00:10:13,169
NEUROT

172
00:10:13,169 --> 00:10:23,546
NEUROTOXIC BOTULINUM.

173
00:10:37,060 --> 00:10:40,063
THE OBJECTIVE IS THE MEASURES 

174
00:10:40,063 --> 00:10:42,765
FOR BOTULINUM AND WHAT CAN 

175
00:10:42,765 --> 00:10:46,002
REVERSE THE BOTULINUM 

176
00:10:46,002 --> 00:10:46,602
INTOXICATION.

177
00:10:46,602 --> 00:10:52,442
THE AGENTS WOULD COULD INCLUDING

178
00:10:52,442 --> 00:10:54,177
BIOLOGICS FOR DRUGS.

179
00:10:54,177 --> 00:10:57,980
WE'RE PROPOSING A BIPHASIC 

180
00:10:57,980 --> 00:11:01,150
MECHANISMS TO ALLOW UP TO SIX 

181
00:11:01,150 --> 00:11:06,556
R61 RESEARCH PROJECTS AND THEN 

182
00:11:06,556 --> 00:11:09,158
THOSE WILL BE DOWN SELECTED WITH

183
00:11:09,158 --> 00:11:13,129
AGREED UPON MILESTONES R33 

184
00:11:13,129 --> 00:11:13,396
PROJECTS.

185
00:11:13,396 --> 00:11:14,630
THE TOTAL COST FOR THE 

186
00:11:14,630 --> 00:11:17,133
INITIATIVE IS ANTICIPATED TO BE 

187
00:11:17,133 --> 00:11:21,404
$2.9 MILLION EACH YEAR FOR FIVE 

188
00:11:21,404 --> 00:11:23,172
YEARS.

189
00:11:23,172 --> 00:11:24,707
FOR THE REST OF THE TALK I'M 

190
00:11:24,707 --> 00:11:26,576
REFERRING TO THE PHASE OF THE 

191
00:11:26,576 --> 00:11:27,076
AWARD.

192
00:11:27,076 --> 00:11:29,145
BUT ALL OF THESE ARE PRE 

193
00:11:29,145 --> 00:11:30,947
CLINICAL IN NATURE.

194
00:11:30,947 --> 00:11:33,583
SO NO HUMAN CLINICAL TRIALS WILL

195
00:11:33,583 --> 00:11:40,590
BE SUPPORTED UNDER THE 

196
00:11:40,590 --> 00:11:45,161
INITIATIVE.

197
00:11:45,161 --> 00:11:47,263
CLOSTRIDIUM BOTULINUM NEUROTOXIN

198
00:11:47,263 --> 00:11:48,764
ARE BIO THREATS AND EASY TO GROW

199
00:11:48,764 --> 00:11:53,136
AND MAKE THE MOST POTENT TOXINS 

200
00:11:53,136 --> 00:11:53,336
KNOW.

201
00:11:53,336 --> 00:11:56,806
THERE'S SEVEN ESTABLISHED 

202
00:11:56,806 --> 00:11:57,340
SEROTYPESA-G.

203
00:11:57,340 --> 00:12:06,282
IT CAN CAUSE FLACCID PARALYSIS 

204
00:12:06,282 --> 00:12:10,319
AND AND SYMPTOMS START 6 TO 36 

205
00:12:10,319 --> 00:12:11,654
HOURS AFTER EXPOSURE AND THE 

206
00:12:11,654 --> 00:12:19,996
PRAL LIST PROGRESSES TO THE 

207
00:12:19,996 --> 00:12:21,731
EXTREMITIES AND PARALYSIS TO THE

208
00:12:21,731 --> 00:12:23,366
RESPIRATORY SYSTEM.

209
00:12:23,366 --> 00:12:27,303
THERE'S A 5-10% WHEN PATIENTS 

210
00:12:27,303 --> 00:12:30,673
ARE TREATED WITH MEASURES IN A 

211
00:12:30,673 --> 00:12:34,610
GARDEN VARIETY EVENT USUALLY 

212
00:12:34,610 --> 00:12:35,244
INGESTION.

213
00:12:35,244 --> 00:12:38,047
HOWEVER, IN AN INTENTIONAL 

214
00:12:38,047 --> 00:12:43,486
RELEASE THIS MORTALITY RATE IS 

215
00:12:43,486 --> 00:12:45,621
PROJECTED TO BE MUCH HIGHER.

216
00:12:45,621 --> 00:12:49,158
THE CURRENT COUNTER MEASURES ARE

217
00:12:49,158 --> 00:12:53,596
MECHANICAL VENTILATION AND THESE

218
00:12:53,596 --> 00:12:54,597
ARE STORED IN THE STRATEGIC 

219
00:12:54,597 --> 00:12:55,831
NATIONAL STOCKPILE AND 

220
00:12:55,831 --> 00:12:57,533
DISSEMINATED BY CDC.

221
00:12:57,533 --> 00:12:59,735
THEY'RE SPREAD AROUND THE UNITED

222
00:12:59,735 --> 00:13:04,640
STATES AND SO IF ANTI-TOXIN IS 

223
00:13:04,640 --> 00:13:06,842
NEED FOR A PATIENT WITH 

224
00:13:06,842 --> 00:13:10,112
SUSPECTED BOTULISM IT CAN BE 

225
00:13:10,112 --> 00:13:10,780
PROVIDED TO A HOSPITAL ANYWHERE 

226
00:13:10,780 --> 00:13:12,815
WHEREIN THE UNITED STATES.

227
00:13:12,815 --> 00:13:14,584
SO A LITTLE BIT MORE ABOUT THE 

228
00:13:14,584 --> 00:13:16,619
COUNTER MEASURES THAT ARE 

229
00:13:16,619 --> 00:13:17,720
CURRENTLY AVAILABLE.

230
00:13:17,720 --> 00:13:21,891
THE MAIN COUNTER MEASURES TO 

231
00:13:21,891 --> 00:13:25,428
TREAT IN THE UNITED STATES ARE 

232
00:13:25,428 --> 00:13:33,135
BAT, WHICH IS EQUINE PEPTO VEIL 

233
00:13:33,135 --> 00:13:39,942
ENT AND IT'S A MONOCLONAL BASED 

234
00:13:39,942 --> 00:13:44,146
ANTITOXIN WITH PROTECTION 

235
00:13:44,146 --> 00:13:47,183
AGAINST THE TYPES A AND B.

236
00:13:47,183 --> 00:13:57,159
BAT AND BABY BIG ARE BOTH IV 

237
00:13:57,159 --> 00:14:00,129
ADMINISTERED THEY MUST BE GIVEN 

238
00:14:00,129 --> 00:14:04,634
WITH 6 TO 48 HOURS AND THIS 

239
00:14:04,634 --> 00:14:09,438
TIGHT WINDOW NECESSITATES 

240
00:14:09,438 --> 00:14:10,640
TREATMENT BASED ON CLINICAL 

241
00:14:10,640 --> 00:14:11,240
SYMPTOMS.

242
00:14:11,240 --> 00:14:13,709
FURTHER, LAB CONFIRMATION TAKES 

243
00:14:13,709 --> 00:14:15,811
ABOUT FIVE DAYS SO WAIT BEING 

244
00:14:15,811 --> 00:14:17,446
FOR LAB CONFIRMATION WOULD PLACE

245
00:14:17,446 --> 00:14:19,148
A PATIENT BEYOND THE TREATMENT 

246
00:14:19,148 --> 00:14:28,057
WINDOW FOR BAT AND BABY BIG WHY 

247
00:14:28,057 --> 00:14:32,261
WE NEED A HEPTO VALENT TREATMENT

248
00:14:32,261 --> 00:14:34,664
AND IT NECESSITATES SOMEONE 

249
00:14:34,664 --> 00:14:36,399
STAYING NEAR THE PATIENT WHO 

250
00:14:36,399 --> 00:14:37,833
RECEIVE THE IV INFUSION TO 

251
00:14:37,833 --> 00:14:39,702
MONITOR THE INFUSIONS.

252
00:14:39,702 --> 00:14:42,004
THIS POTENTIALLY LIMITS THE 

253
00:14:42,004 --> 00:14:45,374
FUTILITY IN A MASS EXPOSURE 

254
00:14:45,374 --> 00:14:49,145
EVENT.

255
00:14:49,145 --> 00:14:52,648
FINALLY, THOUGH THERE'S BATCH IT

256
00:14:52,648 --> 00:14:53,582
BATCH VARIATION.

257
00:14:53,582 --> 00:14:54,917
THERE'S NO COUNTER MEASURES 

258
00:14:54,917 --> 00:15:00,556
AVAILABLE TO REVERSE 

259
00:15:00,556 --> 00:15:01,223
INTOXICATION.

260
00:15:01,223 --> 00:15:05,127
PATIENTS EXPERIENCING BOTULINUM 

261
00:15:05,127 --> 00:15:08,064
AND MUSCLE TOXINS WILL NEED 

262
00:15:08,064 --> 00:15:10,666
SUPPORT WITH VENTILATORS AND 

263
00:15:10,666 --> 00:15:13,035
FEEDING TUBES UNTIL THE NEURONS 

264
00:15:13,035 --> 00:15:14,503
REGROW.

265
00:15:14,503 --> 00:15:16,072
THIS PROCESS CAN TAKE WEEKS OR 

266
00:15:16,072 --> 00:15:17,807
MONTHS AND COULD STRESS A 

267
00:15:17,807 --> 00:15:20,142
HOSPITAL'S ICU.

268
00:15:20,142 --> 00:15:22,645
AFTERWARDS, PATIENTS WHO DO 

269
00:15:22,645 --> 00:15:26,549
SURVIVE BOTULISM MAY HAVE 

270
00:15:26,549 --> 00:15:28,184
FATIGUE AND SHORTNESS OF BREATH 

271
00:15:28,184 --> 00:15:30,853
FOR YEARS AND MAY NEED THERAPY 

272
00:15:30,853 --> 00:15:35,157
TO HELP THEM FULLY RECOVER.

273
00:15:35,157 --> 00:15:37,660
THREES A CRITICAL NEED FOR THE 

274
00:15:37,660 --> 00:15:38,894
COUNTER MEASURES.

275
00:15:38,894 --> 00:15:40,396
THESE COUNTER MEASURES WOULD 

276
00:15:40,396 --> 00:15:41,697
POTENTIALLY WORK BY EITHER 

277
00:15:41,697 --> 00:15:43,599
NEUTRALIZING CIRCULATING TOXIN 

278
00:15:43,599 --> 00:15:47,803
OR DEGRADING TOXIN ONCE IT'S IN 

279
00:15:47,803 --> 00:15:48,504
THE NEURON.

280
00:15:48,504 --> 00:15:51,640
THIS INITIATIVE SEEKS TO PROMOTE

281
00:15:51,640 --> 00:15:54,143
THE DEVELOPMENT OF ANTITOXINS 

282
00:15:54,143 --> 00:15:57,179
THAT REVERSE INTOXICATION WHICH 

283
00:15:57,179 --> 00:15:59,281
IS SOMETHING THAT THE CURRENT 

284
00:15:59,281 --> 00:16:03,452
COUNTER MEASURES CANNOT DO.

285
00:16:03,452 --> 00:16:05,154
NOVEL THERAPEUTICS THAT CAN 

286
00:16:05,154 --> 00:16:07,223
REVERSE NEURONAL INTOXICATION 

287
00:16:07,223 --> 00:16:08,157
WOULD EXTEND THE THERAPEUTIC 

288
00:16:08,157 --> 00:16:10,793
WINDOW AND GET PEOPLE OUT OF 

289
00:16:10,793 --> 00:16:13,496
ICU.

290
00:16:13,496 --> 00:16:15,698
WE HAVE THE TROJAN HORSE 

291
00:16:15,698 --> 00:16:19,168
CONCEPT.

292
00:16:19,168 --> 00:16:29,712
AN EXAMPLE IS SHOWN HERE IT'S A 

293
00:16:30,346 --> 00:16:31,547
CHIMERIC FUSION PROTEIN THAT 

294
00:16:31,547 --> 00:16:34,617
USES THE BOTULISM TO TARGET THE 

295
00:16:34,617 --> 00:16:40,022
NEURON AND THEN IT WILL DEVELOP 

296
00:16:40,022 --> 00:16:43,159
THE THERAPEUTIC PAY LOAD 

297
00:16:43,159 --> 00:16:45,127
INTERNEURONALLY AND THERE'S 

298
00:16:45,127 --> 00:16:47,596
MULTI-VALENT ANTIBODIES THAT 

299
00:16:47,596 --> 00:16:49,698
TARGET SEROTYPES AND MOLECULES 

300
00:16:49,698 --> 00:16:51,967
AND ENGINEERED NANO BODY 

301
00:16:51,967 --> 00:16:52,334
PRODUCTS.

302
00:16:52,334 --> 00:16:53,436
THE INITIATIVE WOULD PROMOTE THE

303
00:16:53,436 --> 00:16:55,070
DEVELOPMENT AND REFINEMENT OF 

304
00:16:55,070 --> 00:16:57,173
THERAPEUTIC AGENTS THAT ARE 

305
00:16:57,173 --> 00:16:59,742
PLATFORM AGNOSTIC.

306
00:16:59,742 --> 00:17:00,810
AND THE RECENT ADVANCES IN 

307
00:17:00,810 --> 00:17:03,813
TECHNOLOGY HAVE LAID THE 

308
00:17:03,813 --> 00:17:05,581
FOUNDATIONAL WORK FOR THIS 

309
00:17:05,581 --> 00:17:08,484
PROPOSED INITIATIVE.

310
00:17:08,484 --> 00:17:11,687
FINALLY, BARDA HAS SIGNALLED 

311
00:17:11,687 --> 00:17:12,354
THEY'RE INTERESTED IN ADVANCING 

312
00:17:12,354 --> 00:17:14,590
THE DEVELOPMENT AND POTENTIAL 

313
00:17:14,590 --> 00:17:16,158
LICENSING OF NOVEL THERAPEUTICS 

314
00:17:16,158 --> 00:17:19,361
FOR BOTULISM.

315
00:17:19,361 --> 00:17:22,631
HOWEVER, IT'S NIAID'S MANDATE TO

316
00:17:22,631 --> 00:17:23,833
DEVELOP THE NOVEL THERAPEUTICS 

317
00:17:23,833 --> 00:17:27,636
BARDA WOULD BE PROCURING.

318
00:17:27,636 --> 00:17:30,940
AS I INDICATED EARLIER, THIS IS 

319
00:17:30,940 --> 00:17:32,441
A BIPHASIC AWARD.

320
00:17:32,441 --> 00:17:34,543
BEFORE THE AWARD IS MADE, 

321
00:17:34,543 --> 00:17:36,579
MILESTONES THAT ARE ALL 

322
00:17:36,579 --> 00:17:40,449
PEER-REVIEWED WILL BE 

323
00:17:40,449 --> 00:17:43,519
RENEGOTIATED AND WE ANTICIPATE 

324
00:17:43,519 --> 00:17:45,788
THE R61 PHASE OF ACTIVITIES WILL

325
00:17:45,788 --> 00:17:47,590
BE MORE IN THE PROOF OF CONCEPT 

326
00:17:47,590 --> 00:17:49,158
SCREENING AND IDENTIFICATION OF 

327
00:17:49,158 --> 00:17:53,062
NEW THERAPEUTIC AGENTS, 

328
00:17:53,062 --> 00:17:56,799
SYNTHESIZING AND PURIFYING DRUGS

329
00:17:56,799 --> 00:17:59,568
AND INHIBITORS AND LEAD 

330
00:17:59,568 --> 00:18:01,303
CANDIDATE DOWN SELECTION REALM.

331
00:18:01,303 --> 00:18:02,771
AFTER TWO YEARS IN THE R61 

332
00:18:02,771 --> 00:18:04,673
PHASE, APPLICATIONS THAT HAVE 

333
00:18:04,673 --> 00:18:07,543
ACHIEVED THEIR TRANSITION 

334
00:18:07,543 --> 00:18:08,077
MILESTONES AND FOLLOWING 

335
00:18:08,077 --> 00:18:09,979
PROGRAMS INVOLVEMENT AND 

336
00:18:09,979 --> 00:18:11,547
APPROVAL, COULD POTENTIALLY 

337
00:18:11,547 --> 00:18:17,152
TRANSITION TO AN R33 PHASE.

338
00:18:17,152 --> 00:18:20,089
IT'S ANTICIPATED THE R31 PHASE 

339
00:18:20,089 --> 00:18:21,190
WOULD BE MORE ADVANCED 

340
00:18:21,190 --> 00:18:23,659
DEVELOPMENT ACTIVITIES.

341
00:18:23,659 --> 00:18:25,661
THESE WOULD INCLUDE PRE CLINICAL

342
00:18:25,661 --> 00:18:30,566
SAFETY AND EFFICACY STUDIES, 

343
00:18:30,566 --> 00:18:33,736
PKPD AND PROCESS DEVELOPMENT FOR

344
00:18:33,736 --> 00:18:38,974
MANUFACTURE AND ULTIMATELY CMPG 

345
00:18:38,974 --> 00:18:43,145
MANUFACTURE OF LEAD CANDIDATES.

346
00:18:43,145 --> 00:18:46,649
APPLICATIONS WILL ADDRESS A 

347
00:18:46,649 --> 00:18:48,784
THERAPEUTIC NEED SPECIFIC TO 

348
00:18:48,784 --> 00:18:52,221
BONT SUCH AS BUT NOT LIMITED TO 

349
00:18:52,221 --> 00:18:56,525
BOTULINUM AGENTS, THERAPEUTICS 

350
00:18:56,525 --> 00:19:02,865
THAT RESTORE MOTOR AND NEURON 

351
00:19:02,865 --> 00:19:04,633
ACTIVITY FOLLOWING BOTULISM AND 

352
00:19:04,633 --> 00:19:08,537
DELIVER MRRMZ.

353
00:19:08,537 --> 00:19:09,538
-- PLATFORMS.

354
00:19:09,538 --> 00:19:12,107
I'VE HAD A CHANCE TO DISCUSS 

355
00:19:12,107 --> 00:19:19,682
THIS WITH DOCTORS TAYLOR AND 

356
00:19:19,682 --> 00:19:21,150
BOTUSTEAD AND AGREE IT'S 

357
00:19:21,150 --> 00:19:22,051
SOMETHING THAT IS NEEDED FOR 

358
00:19:22,051 --> 00:19:27,590
PREPAREDNESS.

359
00:19:27,590 --> 00:19:33,963
WITH THAT I'M HAPPY TO TAKE ANY 

360
00:19:33,963 --> 00:19:34,663
QUESTIONS.

361
00:19:44,540 --> 00:19:44,707
6:

362
00:19:44,707 --> 00:19:47,242
>> COMMENTS OR QUESTIONS
FROM 

363
00:19:47,242 --> 00:19:47,610
COUNCIL MEMBERS?

364
00:19:47,610 --> 00:19:50,045
HEARING NONE, THANK YOU, AMIR.

365
00:19:50,045 --> 00:19:50,412
>> THANK YOU.

366
00:19:50,412 --> 00:19:58,621
THANK YOU ALL FOR YOUR TIME.

367
00:19:58,621 --> 00:20:01,123
THE COUNCILS WILL NEED TO RECORD

368
00:20:01,123 --> 00:20:03,792
THEIR VOTES IN THE ELECTRIC 

369
00:20:03,792 --> 00:20:04,193
COUNCIL BOOK.

370
00:20:04,193 --> 00:20:05,628
YOU CAN DO IT IN THE END SINCE 

371
00:20:05,628 --> 00:20:07,730
WE DON'T HAVE A DROP DEAD TIME 

372
00:20:07,730 --> 00:20:08,597
THIS AFTERNOON.

373
00:20:08,597 --> 00:20:12,534
SO OUR NEXT PRESENTER IS THERE 

374
00:20:12,534 --> 00:20:13,435
KAITLYN MORABITO FROM THE 

375
00:20:13,435 --> 00:20:14,203
VIROLOGY BRANCH.

376
00:20:14,203 --> 00:20:16,605
>> TODAY, I'M GOING TO
TALK 

377
00:20:16,605 --> 00:20:20,709
ABOUT OUR RENEWAL CONCEPT 

378
00:20:20,709 --> 00:20:22,077
RATIONAL DESIGN OF VACCINES 

379
00:20:22,077 --> 00:20:24,480
AGAINST HEPATITIS C VIRUS.

380
00:20:24,480 --> 00:20:27,683
THIS IS A RENEWAL AND TO 

381
00:20:27,683 --> 00:20:33,155
OPTIMIZE BROADLY PROTECTIVE 

382
00:20:33,155 --> 00:20:34,757
VACCINES FOR HCV AND 

383
00:20:34,757 --> 00:20:38,160
SATISFACTION PROTECTION FOR 

384
00:20:38,160 --> 00:20:41,163
CANDIDATE AGENTS AND 

385
00:20:41,163 --> 00:20:42,865
METHODOLOGIES AND ENABLING 

386
00:20:42,865 --> 00:20:45,100
STUDIES TO ENABLE MOVING THESE 

387
00:20:45,100 --> 00:20:47,603
VACCINE CANDIDATES TOWARDS THE 

388
00:20:47,603 --> 00:20:47,870
CLINIC.

389
00:20:47,870 --> 00:20:49,138
IT IS A RENEWAL.

390
00:20:49,138 --> 00:20:52,207
WE'LL USE A U-19 MECHANISM.

391
00:20:52,207 --> 00:20:56,278
WE'RE ANTICIPATING TWO TO FOUR 

392
00:20:56,278 --> 00:20:59,882
AWARDS AND FIRST YEAR OF $8.3 

393
00:20:59,882 --> 00:21:00,916
MILLION IN COST.

394
00:21:00,916 --> 00:21:03,786
FIRST ON HEPATITIS C.

395
00:21:03,786 --> 00:21:11,527
OR HCV IS A BLOODBORNE VIRUS AND

396
00:21:11,527 --> 00:21:15,297
THE ACUTE INFECTION IS LARGELY 

397
00:21:15,297 --> 00:21:17,132
ASYSTEMATIC OR SOMETIMES MILD 

398
00:21:17,132 --> 00:21:18,067
SYSTEMS.

399
00:21:18,067 --> 00:21:20,202
ONLY A SMALL FRACTION OF PEOPLE 

400
00:21:20,202 --> 00:21:22,671
CLEAR THIS 10% TO 30% AND THE 

401
00:21:22,671 --> 00:21:26,308
REST GO ON TO CLEAR CHRONIC 

402
00:21:26,308 --> 00:21:28,210
HEPATITIS OF A THIRD GO ON TO 

403
00:21:28,210 --> 00:21:31,480
HAVE CIRRHOSIS AND CAN LEAD TO 

404
00:21:31,480 --> 00:21:32,047
CANCER AND END STAGE LIVER 

405
00:21:32,047 --> 00:21:42,191
DISEASE.

406
00:21:48,363 --> 00:21:51,800
IT'S PREVALENT AROUND THE WORLD.

407
00:21:51,800 --> 00:21:56,605
THE W.H.O. HAS GOALS OF 

408
00:21:56,605 --> 00:21:59,041
ELIMINATING AND IT INCLUDES 

409
00:21:59,041 --> 00:22:01,310
PREVENTION OF HCV INFECTIONS AND

410
00:22:01,310 --> 00:22:09,918
INCLUDE RESEARCH OBJECTIVES.

411
00:22:09,918 --> 00:22:12,387
DESPITE THE FOCUS IN 

412
00:22:12,387 --> 00:22:12,688
ELIMINATION.

413
00:22:12,688 --> 00:22:16,158
HCV HAS CONTINUED TO GROW.

414
00:22:16,158 --> 00:22:18,961
IT CORRESPONDS WITH GROWING 

415
00:22:18,961 --> 00:22:19,928
OPIOID EPIDEMIC AND THERE'S BEEN

416
00:22:19,928 --> 00:22:23,832
ABOUT 125% INCREASE IN NEW HCV 

417
00:22:23,832 --> 00:22:24,700
INFECTIONS IN THE UNITED STATES.

418
00:22:24,700 --> 00:22:25,734
THERE'S SOME HOPE IT TAILED OFF 

419
00:22:25,734 --> 00:22:28,670
OR FLATTENED OUT IN THE PAST FEW

420
00:22:28,670 --> 00:22:33,142
YEARS BUT STILL WELL ABOVE THE 

421
00:22:33,142 --> 00:22:43,652
STRATEGIC PLAN ANNUAL TARGET.

422
00:22:45,220 --> 00:22:46,655
THE ANTIVIRALS STOP CHRONIC 

423
00:22:46,655 --> 00:22:48,023
INFECTION BUT STILL SUSCEPTIBLE 

424
00:22:48,023 --> 00:22:51,627
TO RE-INFECTION.

425
00:22:51,627 --> 00:22:52,494
A POINT OF CARE DIAGNOSTIC WAS 

426
00:22:52,494 --> 00:22:53,595
MADE AVAILABLE BUT THERE'S NO 

427
00:22:53,595 --> 00:22:54,863
ROUTINE SCREENING SO A VACCINE 

428
00:22:54,863 --> 00:22:56,899
IS NEEDED TO PREVENT ACUTE AND 

429
00:22:56,899 --> 00:22:58,367
CHRONIC INFECTION AND HOPEFULLY 

430
00:22:58,367 --> 00:23:05,107
LIMIT TRANSMISSION AS WELL.

431
00:23:05,107 --> 00:23:06,775
HCV VACCINE HAS ENCOUNTERED 

432
00:23:06,775 --> 00:23:07,409
NUMEROUS CHALLENGES.

433
00:23:07,409 --> 00:23:09,178
AS MENTIONED BEFORE, ACUTE 

434
00:23:09,178 --> 00:23:10,813
INFECTION CAN GO ON TO BE 

435
00:23:10,813 --> 00:23:12,214
RESOLVED OR CHRONIC.

436
00:23:12,214 --> 00:23:14,283
AND EVEN THOSE WHO RESOLVE ACUTE

437
00:23:14,283 --> 00:23:17,052
INFECTION CAN GO ON TO BE 

438
00:23:17,052 --> 00:23:17,352
RE-INFECTED.

439
00:23:17,352 --> 00:23:24,860
THIS HAS MADE IT DIFFICULT TO 

440
00:23:24,860 --> 00:23:27,262
TEASE OUT WHAT IT LOOKS LIKE.

441
00:23:27,262 --> 00:23:28,664
IT'S HIGHLY DIVERSE.

442
00:23:28,664 --> 00:23:32,668
THERE'S PREDOMINANTLY SIX 

443
00:23:32,668 --> 00:23:33,869
GENOTYPES THAT CIRCULATE.

444
00:23:33,869 --> 00:23:37,573
GENOTYPE 1 AND 3 ARE MOST 

445
00:23:37,573 --> 00:23:39,441
PROMINENT WORLD WIDE IN THE 

446
00:23:39,441 --> 00:23:40,309
UNITED STATES AND OTHERS ARE 

447
00:23:40,309 --> 00:23:45,147
PROMINENT IN OTHER AREAS.

448
00:23:45,147 --> 00:23:47,049
AND IT'S DIFFICULT TO GROW AND 

449
00:23:47,049 --> 00:23:48,517
CULTURE AND DOESN'T REPLICATE 

450
00:23:48,517 --> 00:23:50,018
THE MOST AVAILABLE ANIMAL 

451
00:23:50,018 --> 00:23:50,352
MODELS.

452
00:23:50,352 --> 00:23:52,821
THERE'S NO ANIMAL MODELS EASILY 

453
00:23:52,821 --> 00:23:54,957
AVAILABLE TO EVALUATE EFFICACY 

454
00:23:54,957 --> 00:23:58,093
AND NO STANDARDIZED REAGENTS OR 

455
00:23:58,093 --> 00:23:58,327
ASSAYS.

456
00:23:58,327 --> 00:24:00,262
SO ALL TOGETHER IT'S LED TO A 

457
00:24:00,262 --> 00:24:03,899
LACK OF DEFINED CORRELATES OF 

458
00:24:03,899 --> 00:24:07,469
DETECTION AND FEW HCV VACCINES 

459
00:24:07,469 --> 00:24:12,541
HAVE BEEN TESTED IN PHASE I AND 

460
00:24:12,541 --> 00:24:15,177
II CLINICAL TRIALS.

461
00:24:15,177 --> 00:24:16,678
WE STARTED THE RATIONAL DESIGN 

462
00:24:16,678 --> 00:24:19,948
OF VACCINES AGAINST HEPATITIS C 

463
00:24:19,948 --> 00:24:20,148
VIRUS.

464
00:24:20,148 --> 00:24:24,052
THE OBJECTIVES TO LOOK AT BROAD 

465
00:24:24,052 --> 00:24:27,089
IMMUNOLOGICAL PROTECTION AND 

466
00:24:27,089 --> 00:24:27,856
ELUCIDATE PROTECTION FROM 

467
00:24:27,856 --> 00:24:29,658
SAMPLES FROM COHORTS AND VACCINE

468
00:24:29,658 --> 00:24:32,194
STUDIES AND CONSTRUCTING 

469
00:24:32,194 --> 00:24:34,696
VACCINES AND EVALUATING THEIR 

470
00:24:34,696 --> 00:24:36,932
IMMUNOGENICITY AND DEVELOPING 

471
00:24:36,932 --> 00:24:38,634
NEW ANIMAL MODELS.

472
00:24:38,634 --> 00:24:41,770
WE AWARDED THREE U-19 AWARDS.

473
00:24:41,770 --> 00:24:42,738
THEY'RE CURRENTLY IN THEIR 

474
00:24:42,738 --> 00:24:44,873
FOURTH YEAR AND HAVE BEEN HIGHLY

475
00:24:44,873 --> 00:24:45,641
PRODUCTIVE WITH 27 PUBLICATIONS 

476
00:24:45,641 --> 00:24:50,012
SINCE THE START.

477
00:24:50,012 --> 00:24:51,213
I'LL HIGHLIGHT A FEW 

478
00:24:51,213 --> 00:24:52,447
ACCOMPLISHMENTS THAT SHAPED WHAT

479
00:24:52,447 --> 00:24:58,654
WE'RE THINKING FOR THE RENEWAL 

480
00:24:58,654 --> 00:25:09,031
OF THIS THE E1 AND E2 

481
00:25:11,233 --> 00:25:12,200
GLYCOPROTEIN THEY'VE DONE 

482
00:25:12,200 --> 00:25:15,604
EPITOPE MATCHING AND WE KNOW 

483
00:25:15,604 --> 00:25:19,908
ABOUT THE IMMUNE GENICITY OF THE

484
00:25:19,908 --> 00:25:22,411
VARIETY.

485
00:25:22,411 --> 00:25:25,147
AND LOOKED AT THE STRUCTURAL 

486
00:25:25,147 --> 00:25:26,548
ANALYSIS AND GENETIC ANALYSIS.

487
00:25:26,548 --> 00:25:28,650
SO WE KNOW WHAT TYPES OF 

488
00:25:28,650 --> 00:25:33,555
ANTIBODIES ARE PROTECTIVE.

489
00:25:33,555 --> 00:25:35,324
THEY'VE DONE SOME WORK TO LOOK 

490
00:25:35,324 --> 00:25:37,125
AT DIFFERENTIAL RESPONSES TO 

491
00:25:37,125 --> 00:25:40,095
PRIMARY INFECTION VERSUS 

492
00:25:40,095 --> 00:25:40,696
SECONDARY INFECTION VERSUS 

493
00:25:40,696 --> 00:25:42,364
VACCINATION AND UNDERSTANDING 

494
00:25:42,364 --> 00:25:44,533
MORE IN THE IMMUNE AND ADAPTIVE 

495
00:25:44,533 --> 00:25:45,434
IMMUNE RESPONSES.

496
00:25:45,434 --> 00:25:47,569
AND WORK HAS BEEN DONE TO 

497
00:25:47,569 --> 00:25:49,137
UNDERSTAND AS I MENTIONED BEFORE

498
00:25:49,137 --> 00:25:50,572
CHRONIC INFECTION AND THEN 

499
00:25:50,572 --> 00:25:54,276
THERE'S THERE IS RE-INFECTION 

500
00:25:54,276 --> 00:25:56,311
THAT OCCURS.

501
00:25:56,311 --> 00:25:59,214
HOW VIREMIA RELATE TO DEPTH AND 

502
00:25:59,214 --> 00:26:02,517
POTENCY FROM SERUM.

503
00:26:02,517 --> 00:26:04,086
THEY'VE ALSO BEEN ABLE TO 

504
00:26:04,086 --> 00:26:06,421
GENERATE A NUMBER OF VACCINE 

505
00:26:06,421 --> 00:26:09,057
CANDIDATES USING DIVERSE 

506
00:26:09,057 --> 00:26:09,358
APPROACHES.

507
00:26:09,358 --> 00:26:10,192
SINCE THE CORRELATES HAVE NOT 

508
00:26:10,192 --> 00:26:11,526
BEEN DEFINED.

509
00:26:11,526 --> 00:26:14,763
IT'S NOT CLEAR IF WE NEED B CELL

510
00:26:14,763 --> 00:26:17,866
OR T CELL RESPONSES OR BOTH AND 

511
00:26:17,866 --> 00:26:19,334
STRATEGIES THAT FOCUS ON B CELL 

512
00:26:19,334 --> 00:26:24,840
RESPONSES AND THE E1, E2 

513
00:26:24,840 --> 00:26:27,142
HETERODIMER AND ANTIGENS AND 

514
00:26:27,142 --> 00:26:28,677
THOSE THAT USED ANCESTRAL 

515
00:26:28,677 --> 00:26:29,144
SEQUENCE.

516
00:26:29,144 --> 00:26:30,879
THERE'S BEEN A NUMBER OF 

517
00:26:30,879 --> 00:26:32,047
PLATFORMS ON THE CONTINUUM OF B 

518
00:26:32,047 --> 00:26:39,688
CELL TO T CELL RESPONSES.

519
00:26:39,688 --> 00:26:43,325
THE RATIONALE DESIGN AGAINST 

520
00:26:43,325 --> 00:26:44,926
HCV1.0 HAS HAD AN EXPANSION OF 

521
00:26:44,926 --> 00:26:45,694
FOUNDATIONAL KNOWLEDGE AND THE 

522
00:26:45,694 --> 00:26:47,629
GOAL IS TO TAKE THAT EXPANSION 

523
00:26:47,629 --> 00:26:49,364
OF FOUNDATIONAL KNOWLEDGE AND 

524
00:26:49,364 --> 00:26:54,503
HARNESS IT TO MOVE SOME OF THE 

525
00:26:54,503 --> 00:26:57,139
CANDIDATES TOWARDS THE CLINIC.

526
00:26:57,139 --> 00:26:59,508
TO THE AIM THE RENEWAL WILL HAVE

527
00:26:59,508 --> 00:27:00,242
CONTINUING OBJECTIVES.

528
00:27:00,242 --> 00:27:04,346
WE THINK THERE'S MORE TO 

529
00:27:04,346 --> 00:27:06,548
UNDERSTAND IN STRUCTURAL AND 

530
00:27:06,548 --> 00:27:07,716
IMMUNOLOGICAL BASIS AND USING 

531
00:27:07,716 --> 00:27:09,151
THE VACCINE STUDIES HAVE BEEN 

532
00:27:09,151 --> 00:27:10,652
IMPORTANT FOR UNDERSTANDING THE 

533
00:27:10,652 --> 00:27:11,153
IMMUNE RESPONSE.

534
00:27:11,153 --> 00:27:11,753
THAT WILL CONTINUE TO BE AN 

535
00:27:11,753 --> 00:27:13,622
OBJECTIVE.

536
00:27:13,622 --> 00:27:15,690
AND AS WELL AS THE DESIGN AND 

537
00:27:15,690 --> 00:27:16,925
EVALUATION OF NOVEL ANTIBODY AND

538
00:27:16,925 --> 00:27:20,062
TX VACCINE APPROACHES.

539
00:27:20,062 --> 00:27:21,129
THE ADDITIONAL FOCUS IS HERE 

540
00:27:21,129 --> 00:27:22,998
WILL BE IN THE OPTIMIZATION AND 

541
00:27:22,998 --> 00:27:24,566
DOWN SELECTION OF VACCINE 

542
00:27:24,566 --> 00:27:30,705
CANDIDATES BASED ON IMMUNOGE

543
00:27:30,705 --> 00:27:36,278
IMMUNOGENICITY AND TRANSFORMING 

544
00:27:36,278 --> 00:27:38,180
TO EVALUATION.

545
00:27:38,180 --> 00:27:40,882
I THANK THOSE FOR HELPFUL 

546
00:27:40,882 --> 00:27:41,216
CONVERSATIONS.

547
00:27:41,216 --> 00:27:46,655
A FEW THINGS THAT CAME UP THAT 

548
00:27:46,655 --> 00:27:47,589
VACCINES ARE ADDRESSED IN THE 

549
00:27:47,589 --> 00:27:50,392
W.H.O. HEPATITIS ELIMINATION 

550
00:27:50,392 --> 00:27:51,293
PLAN AND STRATEGIC PLAN.

551
00:27:51,293 --> 00:27:54,930
ONE OF THE OTHER THINGS THAT IS 

552
00:27:54,930 --> 00:27:56,698
DIFFERENT ABOUT 2.0 IS WE 

553
00:27:56,698 --> 00:27:58,200
DECOUPLED ANIMAL MODEL 

554
00:27:58,200 --> 00:27:59,367
DEVELOPMENT FROM THE VACCINE 

555
00:27:59,367 --> 00:28:00,869
DEVELOPMENT AND I WANTED TO 

556
00:28:00,869 --> 00:28:01,703
HIGHLIGHT WE HAD ANOTHER 

557
00:28:01,703 --> 00:28:03,505
INITIATIVE THAT WAS RECENTLY 

558
00:28:03,505 --> 00:28:05,607
AWARDED TO LOOK SPECIFICALLY AT 

559
00:28:05,607 --> 00:28:10,312
ANIMAL MODELS FOR HEPATITIS B 

560
00:28:10,312 --> 00:28:10,745
AND C.

561
00:28:10,745 --> 00:28:12,547
IN THE CONCEPT WE'LL LOOK FOR 

562
00:28:12,547 --> 00:28:14,483
DOWN SELECTION OF VACCINE 

563
00:28:14,483 --> 00:28:16,651
CANDIDATES BASED ON TARGETED 

564
00:28:16,651 --> 00:28:21,890
IMMUNE RESPONSE.

565
00:28:21,890 --> 00:28:23,391
WE TALKED ABOUT POTENTIAL 

566
00:28:23,391 --> 00:28:25,093
POPULATIONS AND GENOTYPES.

567
00:28:25,093 --> 00:28:25,794
WE HAVEN'T SPECIFIED IN THE CALL

568
00:28:25,794 --> 00:28:28,663
WHAT THE TARGET POPULATION OR 

569
00:28:28,663 --> 00:28:32,134
WHAT GENOTYPE WOULD BE TARGETED 

570
00:28:32,134 --> 00:28:33,135
BUT WOULD NEED TO BE LOOKED INTO

571
00:28:33,135 --> 00:28:37,772
FOR THE INVESTIGATORS.

572
00:28:37,772 --> 00:28:40,675
AND I'LL BE HAPPY TO TAKE ANY 

573
00:28:40,675 --> 00:28:41,810
QUESTIONS.

574
00:28:41,810 --> 00:28:44,479
>> THANK YOU, KAITLYN.

575
00:28:44,479 --> 00:28:46,414
ANY QUESTIONS FROM COUNCIL 

576
00:28:46,414 --> 00:28:46,948
MEMBERS OR ANY ADDITIONAL 

577
00:28:46,948 --> 00:28:56,591
COMMENTS?

578
00:28:56,591 --> 00:28:58,193
>> I HAVE A QUESTION
RELATED TO 

579
00:28:58,193 --> 00:29:02,998
THE GENOTYPES WHAT IS KNOWN 

580
00:29:02,998 --> 00:29:05,167
ABOUT THE DIFFERENCE BETWEEN HOW

581
00:29:05,167 --> 00:29:08,837
THE GENOTYPES DIFFER?

582
00:29:08,837 --> 00:29:10,672
ARE THEY SIMILAR OR DIFFERENT OR

583
00:29:10,672 --> 00:29:12,674
IS THAT KNOWN YET?

584
00:29:12,674 --> 00:29:15,544
>> THERE'S SOME
SIMILARITIES AN 

585
00:29:15,544 --> 00:29:17,345
DIFFERENCES AND GENOTYPE DOESN'T

586
00:29:17,345 --> 00:29:22,150
PREDICT WHETHER AN ANTIBODY 

587
00:29:22,150 --> 00:29:24,186
WOULD NEUTRALIZE OR NOT SO IT'S 

588
00:29:24,186 --> 00:29:24,586
COMPLICATED.

589
00:29:24,586 --> 00:29:27,756
>> THE GOAL IS EVEN IF IT 

590
00:29:27,756 --> 00:29:29,524
FOCUSSED ON A SINGLE GENOTYPE 

591
00:29:29,524 --> 00:29:30,158
THAT WOULD BE INTERESTED TO BE 

592
00:29:30,158 --> 00:29:37,132
QUITE AN ADVANCE?

593
00:29:37,132 --> 00:29:40,235
GOODNIGHT  

594
00:29:40,735 --> 00:29:49,444
GENOTYPE 1 AND 3 ARE MOST 

595
00:29:49,444 --> 00:29:49,678
COMMON.

596
00:29:49,678 --> 00:29:57,118
>> ANY ADDITIONAL
QUESTIONS?

597
00:29:57,118 --> 00:30:04,125
THANK YOU, KAITLYN.

598
00:30:04,125 --> 00:30:09,130
OUR NEXT FISCAL YEAR '26 CONCEPT

599
00:30:09,130 --> 00:30:12,400
WILL BE PRESENTED BY THAMES 

600
00:30:12,400 --> 00:30:13,902
PICKETT FROM OBRRTR.

601
00:30:13,902 --> 00:30:15,770
THERE WE GO.

602
00:30:15,770 --> 00:30:17,872
>> GOOD AFTERNOON,
EVERYONE.

603
00:30:17,872 --> 00:30:20,275
I'M THAMES PICKETT.

604
00:30:20,275 --> 00:30:22,310
I'M PRESENTING THE IN VITRO 

605
00:30:22,310 --> 00:30:24,112
ASSESSMENTS OF ANTIMICROBIAL 

606
00:30:24,112 --> 00:30:25,146
ACTIVITY CONCEPT.

607
00:30:25,146 --> 00:30:27,482
THE OBJECTIVES ARE TO SCREEN -- 

608
00:30:27,482 --> 00:30:29,284
>> CAN YOU GET CLOSER TO
THE 

609
00:30:29,284 --> 00:30:29,584
MICROPHONE?

610
00:30:29,584 --> 00:30:31,453
>> SURE.

611
00:30:31,453 --> 00:30:33,121
THE OBJECTIVES ARE TO SCREEN 

612
00:30:33,121 --> 00:30:36,024
THERAPEUTIC CANDIDATES MAINLY 

613
00:30:36,024 --> 00:30:38,793
FOR EXTERNAL REQUESTERS, PRODUCT

614
00:30:38,793 --> 00:30:42,264
SPONSORS AND CHEMICAL COLLECTION

615
00:30:42,264 --> 00:30:45,834
OF INTEREST AND WELL 

616
00:30:45,834 --> 00:30:49,104
CHARACTERIZED TRAVEL MATERIAL 

617
00:30:49,104 --> 00:30:51,039
FOR PATHOGENS AND PRODUCE 

618
00:30:51,039 --> 00:30:52,674
DEVELOP METHODS FOR GROWING 

619
00:30:52,674 --> 00:30:55,243
DIFFICULT TO CULTURE ORGANISMS.

620
00:30:55,243 --> 00:30:57,912
THIS IS A RENEWAL OF INDEFINITE 

621
00:30:57,912 --> 00:31:02,751
QUANT OR IDIQ CONTRACT OF THE 

622
00:31:02,751 --> 00:31:07,055
SAME NAME AND WE PLAN TO AWARD 

623
00:31:07,055 --> 00:31:09,124
BETWEEN 15 AND 25 BASE 

624
00:31:09,124 --> 00:31:13,128
CONTRACTS.

625
00:31:13,128 --> 00:31:17,132
TO SUPPORT ITS MISSION, DMID 

626
00:31:17,132 --> 00:31:18,566
PROVIDES A BROADBAND SUITE OF 

627
00:31:18,566 --> 00:31:20,669
PRE CLINICAL SERVICES WHICH I 

628
00:31:20,669 --> 00:31:22,637
MAY REFER TO AS PCS GOING 

629
00:31:22,637 --> 00:31:23,838
FORWARD.

630
00:31:23,838 --> 00:31:25,607
THE SERVICES FACILITATE BASIC 

631
00:31:25,607 --> 00:31:27,275
RESEARCH THROUGH ALL PHASES OF 

632
00:31:27,275 --> 00:31:30,178
DEVELOPMENT AND INTENDED TO BE 

633
00:31:30,178 --> 00:31:30,578
GAP FILLING.

634
00:31:30,578 --> 00:31:32,414
THERE'S NO PREREQUISITE TO HAVE 

635
00:31:32,414 --> 00:31:34,482
NIH FUNDING AND THE SERVICES ARE

636
00:31:34,482 --> 00:31:35,450
FREE OF CHARGE.

637
00:31:35,450 --> 00:31:38,753
THE OUTPUT IS PRIMARILY PRODUCT 

638
00:31:38,753 --> 00:31:40,689
SPECIFIC DATA GENERATED BY THE 

639
00:31:40,689 --> 00:31:43,792
CONTRACTORS AND PROVIDED TO THE 

640
00:31:43,792 --> 00:31:45,327
PRODUCT SPONSORS.

641
00:31:45,327 --> 00:31:46,695
IVAAA IS A CRITICAL COMPONENT OF

642
00:31:46,695 --> 00:31:49,130
THE SUITE OF SERVICES 

643
00:31:49,130 --> 00:31:50,999
REPRESENTING THE EARLIEST PHASE 

644
00:31:50,999 --> 00:31:52,701
IN PRECLINICAL TESTING AND IS 

645
00:31:52,701 --> 00:31:54,436
OFTEN THE ENTRY POINT FOR FUTURE

646
00:31:54,436 --> 00:32:01,910
TESTING DEVELOPMENT.

647
00:32:01,910 --> 00:32:03,511
SO THIS GRAPHIC REPRESENTS THE 

648
00:32:03,511 --> 00:32:05,146
FACT THAT IN VITRO CONTRACTS 

649
00:32:05,146 --> 00:32:07,248
TEST A LARGE NUMBER OF PRODUCTS 

650
00:32:07,248 --> 00:32:09,117
TO IDENTIFY A SMALL NUMBER WITH 

651
00:32:09,117 --> 00:32:10,352
PROMISING ACTIVITY.

652
00:32:10,352 --> 00:32:12,687
IN THIS CASE SINCE 2019 SINCE 

653
00:32:12,687 --> 00:32:14,622
THESE AWARDS WERE MADE FOR THE 

654
00:32:14,622 --> 00:32:17,192
CURRENT CONTRACT, MORE THAN 

655
00:32:17,192 --> 00:32:19,894
5,000 PRODUCTS HAVE BEEN TESTED 

656
00:32:19,894 --> 00:32:22,430
AND 120 PROGRESSED TO IN VIVO 

657
00:32:22,430 --> 00:32:24,265
TESTING THROUGH OTHER 

658
00:32:24,265 --> 00:32:27,202
PRE-CLINICAL SERVICES PROGRAMS.

659
00:32:27,202 --> 00:32:29,104
THIS REPRESENTS 2.75% 

660
00:32:29,104 --> 00:32:29,637
PROGRESSION IN TO IN VIVO 

661
00:32:29,637 --> 00:32:36,845
TESTING.

662
00:32:36,845 --> 00:32:40,682
IN SOME FORM THIS CONTRACT 

663
00:32:40,682 --> 00:32:43,818
PROGRAM HAS EXISTED SINCE 2003 

664
00:32:43,818 --> 00:32:50,291
TO PROVIDE IN VITRO SCREENING 

665
00:32:50,291 --> 00:32:50,558
SERVICES.

666
00:32:50,558 --> 00:32:54,863
IN 2023, 10 CONTRACTS WERE 

667
00:32:54,863 --> 00:32:56,231
AWARDED THAT SUPPORTED IN VITRO 

668
00:32:56,231 --> 00:32:58,566
AND IN VIVO TESTING AND CALLED 

669
00:32:58,566 --> 00:33:09,144
AT THE TIME CATEGORY A THROUGH C

670
00:33:09,144 --> 00:33:13,148
TESTING AND OF THE 10 

671
00:33:13,148 --> 00:33:14,015
CONTRACTORS FIVE WERE 

672
00:33:14,015 --> 00:33:15,617
RESPONSIBLE FOR PERFORMING THE 

673
00:33:15,617 --> 00:33:18,386
IN VITRO TESTING.

674
00:33:18,386 --> 00:33:21,623
IN 2011, 14 CONTRACT AWARD WERE 

675
00:33:21,623 --> 00:33:27,729
MADE UNDER WHAT WAS NOW CALLED 

676
00:33:27,729 --> 00:33:34,702
THE IN VITRO ASSESSMENT OF AN

677
00:33:34,702 --> 00:33:36,504
ANTIMICROBIAL ACTIVITY AND AT 

678
00:33:36,504 --> 00:33:38,606
THIS POINT IT WAS MOVED TO A 

679
00:33:38,606 --> 00:33:40,675
SEPARATE CONTRACT.

680
00:33:40,675 --> 00:33:41,476
EACH ITERATION INCLUDING THE 

681
00:33:41,476 --> 00:33:44,446
CURRENT ONE THE BASE CONTRACTS 

682
00:33:44,446 --> 00:33:47,782
HAVE HAD A SEVEN YEAR ORDERING.

683
00:33:47,782 --> 00:33:51,252
THE CURRENT IVAAA IDIQ CONTRACTS

684
00:33:51,252 --> 00:33:53,721
WERE AWARDED IN 2019.

685
00:33:53,721 --> 00:33:55,590
THE SCOPE WAS ALL PATHOGENS OF 

686
00:33:55,590 --> 00:33:57,892
INTEREST TO DMID.

687
00:33:57,892 --> 00:33:59,160
14 CONTRACTS WERE AWARDED.

688
00:33:59,160 --> 00:34:04,165
THE CONTRACTOR POOL IN TOTAL IS 

689
00:34:04,165 --> 00:34:04,566
14 CONTRACTORS.

690
00:34:04,566 --> 00:34:07,836
WHEN THE RFP WAS ISSUED THE PLAN

691
00:34:07,836 --> 00:34:10,038
WAS TO DIVIDE THE WORK INTO FIVE

692
00:34:10,038 --> 00:34:14,342
TEST AREAS.

693
00:34:14,342 --> 00:34:20,748
TESTING FOR ANTI-TOXINS, 

694
00:34:20,748 --> 00:34:22,951
ANTIVIRALS AND COUNTER MEASURES 

695
00:34:22,951 --> 00:34:31,926
AND TECHNOLOGIES AND DEVELOPIIN 

696
00:34:31,926 --> 00:34:33,127
METHOD FOR DIFFICULT TO GROW 

697
00:34:33,127 --> 00:34:33,728
PATHOGENS.

698
00:34:33,728 --> 00:34:36,464
NO PROPOSALS WERE RECEIVED FOR 

699
00:34:36,464 --> 00:34:38,433
THE HOLLOW FIBER TECHNOLOGIES.

700
00:34:38,433 --> 00:34:40,201
THAT'S WHY IT'S GRAYED OUT.

701
00:34:40,201 --> 00:34:41,703
THE FINAL POOL HAD JUST FOUR 

702
00:34:41,703 --> 00:34:44,772
TASK AREAS AND THOSE ARE THE 

703
00:34:44,772 --> 00:34:46,341
SAME TASK AREAS THAT WILL BE 

704
00:34:46,341 --> 00:34:49,143
CARRIED FORWARD UNDER THE 

705
00:34:49,143 --> 00:34:51,246
CURRENT CONCEPT.

706
00:34:51,246 --> 00:34:53,481
SOME WERE AWARDED UNDER A 

707
00:34:53,481 --> 00:34:57,118
SEPARATE IDIQ.

708
00:34:57,118 --> 00:35:00,288
THAT TECHNOLOGY IS COVERED.

709
00:35:00,288 --> 00:35:01,756
REQUESTS COME FROM ALL SECTORS 

710
00:35:01,756 --> 00:35:03,925
AND FROM MORE THAN 20 COUNTRIES.

711
00:35:03,925 --> 00:35:05,994
OVER 50% OF REQUESTS ARE FROM 

712
00:35:05,994 --> 00:35:07,896
INDUSTRY AND THE VAST MAJORITY 

713
00:35:07,896 --> 00:35:12,166
ARE SMALL BUSINESSES AND 

714
00:35:12,166 --> 00:35:14,702
PRIVATELY HELD BUSINESSES.

715
00:35:14,702 --> 00:35:16,671
MANY ARE START-UPS THAT RELY ON 

716
00:35:16,671 --> 00:35:18,306
THE DATA TO MOVE FORWARD WITH 

717
00:35:18,306 --> 00:35:22,944
THEIR IDEAS.

718
00:35:22,944 --> 00:35:26,180
ABOUT 30% OF REQUESTS COME FROM 

719
00:35:26,180 --> 00:35:28,650
ACADEMIA AND THE REST ARE 

720
00:35:28,650 --> 00:35:29,717
DIVIDED AMONG OTHER GOVERNMENT 

721
00:35:29,717 --> 00:35:33,821
AGENCIES, NONPROFITS AND OTHERS.

722
00:35:33,821 --> 00:35:39,494
ABOUT TWO-THIRDS OF TESTING 

723
00:35:39,494 --> 00:35:42,797
UNDER THIS PROGRAM IS ANTIVIRAL 

724
00:35:42,797 --> 00:35:43,031
TESTING.

725
00:35:43,031 --> 00:35:46,367
THE VAST MAJORITY OF COUNTER 

726
00:35:46,367 --> 00:35:47,502
MEASURES TESTED, 

727
00:35:47,502 --> 00:35:48,336
HIGH-CONSEQUENCE PATHOGENS WE 

728
00:35:48,336 --> 00:35:52,340
HEARD ABOUT ALL DAY INCLUDING 

729
00:35:52,340 --> 00:35:53,107
VIRUSES HAVING PANDEMIC 

730
00:35:53,107 --> 00:35:56,878
POTENTIAL, BACTERIA AND FUNGI 

731
00:35:56,878 --> 00:36:01,115
LISTED IN THE CDC 2019 

732
00:36:01,115 --> 00:36:04,319
ANTIMICROBIAL THREAT REPORT AND 

733
00:36:04,319 --> 00:36:04,919
BACTERIA ON THE SELECT AGENT 

734
00:36:04,919 --> 00:36:10,758
LIST.

735
00:36:10,758 --> 00:36:12,760
SO I HAVE DIVIDED FOR THE 

736
00:36:12,760 --> 00:36:17,031
PURPOSE OF THIS TALK, I'VE 

737
00:36:17,031 --> 00:36:21,135
DIVIDED THE EFFORTS TO SCREEN 

738
00:36:21,135 --> 00:36:24,038
ANTIBACTERIAL, ANTI-FUNGAL 

739
00:36:24,038 --> 00:36:25,139
PRODUCTS FOR THAT PERFORMED FOR 

740
00:36:25,139 --> 00:36:26,941
PRODUCT SPONSORS AND THAT WHICH 

741
00:36:26,941 --> 00:36:28,242
PERFORMED AS BROADER SCREENING 

742
00:36:28,242 --> 00:36:33,715
AB  ACTIVITIES.

743
00:36:33,715 --> 00:36:35,617
THERE'LL BE TESTING DEPICTED FOR

744
00:36:35,617 --> 00:36:36,985
PRODUCT SPONSORS.

745
00:36:36,985 --> 00:36:39,454
IT'S FOCUSSED ON AMR THREATS AND

746
00:36:39,454 --> 00:36:43,324
TIER 1 SELECT AGENTS.

747
00:36:43,324 --> 00:36:45,126
THE PREFERRED PRE REQUEST FOR 

748
00:36:45,126 --> 00:36:47,895
PRODUCT SPONSORS IS EVIDENCE OF 

749
00:36:47,895 --> 00:36:51,366
SOME IN VITRO ACTIVITY AGAINST A

750
00:36:51,366 --> 00:36:52,700
RELEVANT SPECIES OF BACTERIA OR 

751
00:36:52,700 --> 00:36:56,437
FUNGI.

752
00:36:56,437 --> 00:36:58,706
THE EXPECTATION IS ANY POSITIVE 

753
00:36:58,706 --> 00:37:01,075
DATA FROM THE TESTING ALONG WITH

754
00:37:01,075 --> 00:37:03,645
IN VIVO DATA WILL BE USED TO 

755
00:37:03,645 --> 00:37:07,682
PROKUSE FURTHER FUNDING OR 

756
00:37:07,682 --> 00:37:09,117
INVESTMENTS SUPPORT FOR FURTHER 

757
00:37:09,117 --> 00:37:10,618
DEVELOPMENT.

758
00:37:10,618 --> 00:37:15,523
AS NOTED HERE, 52 REQUESTERS 

759
00:37:15,523 --> 00:37:19,293
HAVE ASKED FOR ANTI-FUNGAL 

760
00:37:19,293 --> 00:37:23,965
TESTING AND 68 FOR ANTIBACTERIA 

761
00:37:23,965 --> 00:37:27,368
TESTING AND THE NUMBER THAT 

762
00:37:27,368 --> 00:37:31,039
MOVED TO IN VIVO TESTING 

763
00:37:31,039 --> 00:37:31,806
INTERCEPT QUITE AS HIGH.

764
00:37:31,806 --> 00:37:34,709
SO IN TERMS OF ACHIEVEMENTS IN 

765
00:37:34,709 --> 00:37:40,682
THIS AREA, MORE THAN 10% OF THE 

766
00:37:40,682 --> 00:37:43,251
ANTIBACTERIAL AND ANTI-FUNGAL 

767
00:37:43,251 --> 00:37:43,851
PRODUCTS MOVED ON TO TESTING 

768
00:37:43,851 --> 00:37:52,460
UNDER THE PROGRAM.

769
00:37:52,460 --> 00:37:53,828
IN VITRO DATA CAN HAVE SELECTION

770
00:37:53,828 --> 00:37:55,196
OF A PRIMARY INDICATION AND DATA

771
00:37:55,196 --> 00:37:58,700
HAVE BEEN USED DOWN THE LINE IN 

772
00:37:58,700 --> 00:37:59,734
REGULATORY SUBMISSIONS.

773
00:37:59,734 --> 00:38:01,402
ONE INTERESTING ACHIEVEMENT IS 

774
00:38:01,402 --> 00:38:06,641
THAT EVERY CLINICAL STAGE 

775
00:38:06,641 --> 00:38:08,109
ANTIFUNGAL HAS BEEN TESTED 

776
00:38:08,109 --> 00:38:16,684
EXCEPT ONE THROUGH IN VIVO 

777
00:38:16,684 --> 00:38:18,586
CONTRACT IS.

778
00:38:18,586 --> 00:38:20,221
I'VE LITTED A COUPLE 

779
00:38:20,221 --> 00:38:22,690
PUBLICATIONS DOCUMENTING THE 

780
00:38:22,690 --> 00:38:24,158
FOUNDATIONAL IMPACT OF THE 

781
00:38:24,158 --> 00:38:27,061
PROGRAM ON TWO OF THE DRUGS.

782
00:38:27,061 --> 00:38:30,064
FINALLY, THIS TESTING HAS 

783
00:38:30,064 --> 00:38:31,733
SUPPORTED SEVERAL INVESTIGATORS 

784
00:38:31,733 --> 00:38:35,136
IN THE CARBX PROGRAM BEING A 

785
00:38:35,136 --> 00:38:40,108
GLOBAL NONPROFIT ACCELERATOR TO 

786
00:38:40,108 --> 00:38:42,844
ADDRESS ANTIMICROBIAL 

787
00:38:42,844 --> 00:38:44,645
RESISTANCE.

788
00:38:44,645 --> 00:38:47,982
NIAID S IN-KIND SERVICES TO 

789
00:38:47,982 --> 00:38:49,951
SUPPORT INVESTIGATORS AND 

790
00:38:49,951 --> 00:38:52,687
CURRENTLY FIVE CARB-X PROGRAMS 

791
00:38:52,687 --> 00:38:53,488
GRADUATES HAVE BEEN SUPPORTED BY

792
00:38:53,488 --> 00:39:03,698
THE PROGRAM.

793
00:39:04,766 --> 00:39:05,066
AIN IN 

794
00:39:07,702 --> 00:39:13,141
IN ADDITION, THE CONTRACT HAS 

795
00:39:13,141 --> 00:39:15,643
PROVIDED MORE BROAD SCREENING OF

796
00:39:15,643 --> 00:39:17,178
PROMISING CHEMICAL COLLECTIONS.

797
00:39:17,178 --> 00:39:20,681
THE FIRST POINT IS IN A 

798
00:39:20,681 --> 00:39:22,250
COLLABORATION WITH NATIONAL 

799
00:39:22,250 --> 00:39:23,084
CANCER INSTITUTE A LARGE NATURAL

800
00:39:23,084 --> 00:39:25,553
PRODUCT SCREEN WAS UNDERTAKEN 

801
00:39:25,553 --> 00:39:28,055
AGAINST A PANEL OF BACTERIAL AND

802
00:39:28,055 --> 00:39:28,689
FUNGAL SPECIES.

803
00:39:28,689 --> 00:39:32,627
AND IN THIS CASE 300,000 

804
00:39:32,627 --> 00:39:33,494
PARTIALLY PURIFIED PRODUCT 

805
00:39:33,494 --> 00:39:35,129
FRACTION TESTED.

806
00:39:35,129 --> 00:39:38,366
OVER 3,000 IDENTIFIED AS HAVING 

807
00:39:38,366 --> 00:39:41,135
ANTI-FUNGAL ACTIVITY AND A 

808
00:39:41,135 --> 00:39:46,541
SUBSET OF THESE WERE PURIFIED 

809
00:39:46,541 --> 00:39:49,143
AND THEIR STRUCTURES ASSESSED 

810
00:39:49,143 --> 00:39:54,515
AND FOUND TO REPRESENT HAVING 

811
00:39:54,515 --> 00:39:58,119
ANTIMICROBIAL ACTIVITY THAT LAD 

812
00:39:58,119 --> 00:40:00,121
NOT BEEN PREVIOUSLY IDENTIFIED.

813
00:40:00,121 --> 00:40:03,491
THE SECOND IS MIC SCREENING FOR 

814
00:40:03,491 --> 00:40:06,627
THE CHEMISTRY CENTER FOR 

815
00:40:06,627 --> 00:40:10,631
COMBATTING ANTIMOOISH YAL  -- 

816
00:40:17,205 --> 00:40:21,142
ANTIMICROBIAL MATTER IN DRUG 

817
00:40:21,142 --> 00:40:22,476
DISCOVERY.

818
00:40:22,476 --> 00:40:25,112
IT'S PERFORMED A PANEL OF DRUG 

819
00:40:25,112 --> 00:40:26,180
RESIST TAPT AND WILD TYPE 

820
00:40:26,180 --> 00:40:29,350
STRAINS TO ALLOW THE PROVISION 

821
00:40:29,350 --> 00:40:33,321
OF A COMMON BASELINE FOR FURTHER

822
00:40:33,321 --> 00:40:33,621
DEVELOPMENT.

823
00:40:33,621 --> 00:40:37,124
ALL MIC RESULTS ARE ADDED TO THE

824
00:40:37,124 --> 00:40:38,860
CC FOR CARB DATABASE AND 

825
00:40:38,860 --> 00:40:41,362
PROVIDED TO INVESTIGATORS TO 

826
00:40:41,362 --> 00:40:43,598
FACILITATE STRUCTURE ACTIVITY 

827
00:40:43,598 --> 00:40:44,232
RELATIONSHIP STUDIES AND EARLY 

828
00:40:44,232 --> 00:40:46,701
DEVELOPMENT.

829
00:40:46,701 --> 00:40:50,905
SO MOVING ON TO ANTIVIRAL 

830
00:40:50,905 --> 00:40:51,372
SCREENING.

831
00:40:51,372 --> 00:40:54,876
THE GOAL IS TO IDENTIFY PRODUCTS

832
00:40:54,876 --> 00:40:56,244
EXHIBITING MAXIMAL VIRAL 

833
00:40:56,244 --> 00:40:59,080
INHIBITION WITH MINIMAL 

834
00:40:59,080 --> 00:40:59,714
TOXICITY.

835
00:40:59,714 --> 00:41:04,752
THESE ARE ALL CELL-BASED ASSAYS.

836
00:41:04,752 --> 00:41:07,822
THESE REPRESENT COST-EFFICIENCY 

837
00:41:07,822 --> 00:41:08,990
AS WELL AS QUICK TURN AROUND 

838
00:41:08,990 --> 00:41:10,358
WITH WHICH PARTICULARLY 

839
00:41:10,358 --> 00:41:11,459
IMPORTANT TO GETTING INFORMATION

840
00:41:11,459 --> 00:41:16,197
BACK TO THE DEVELOPERS QUICKLY.

841
00:41:16,197 --> 00:41:18,065
THE FOCUS AS I MENTIONED BEFORE,

842
00:41:18,065 --> 00:41:21,736
MOST OF THE TESTING HAS BEEN 

843
00:41:21,736 --> 00:41:23,504
DONE AGAINST PANDEMIC VIRUSES 

844
00:41:23,504 --> 00:41:26,007
ALONG WITH OTHER VIRUSES BUT 

845
00:41:26,007 --> 00:41:27,875
PRIMARILY THE SEVEN FAMILIES 

846
00:41:27,875 --> 00:41:30,678
THAT HAVE BEEN IDENTIFIED AS 

847
00:41:30,678 --> 00:41:32,480
HAVING PANDEMIC POTENTIAL.

848
00:41:32,480 --> 00:41:38,920
TESTING IS ORGANIZED INTO TIERS.

849
00:41:38,920 --> 00:41:40,688
PRIMARILY TESTING BEING 

850
00:41:40,688 --> 00:41:42,657
CYTOPATHIC EFFECT AND SECOND IS 

851
00:41:42,657 --> 00:41:45,159
VIRAL YIELD PRODUCTION AND 

852
00:41:45,159 --> 00:41:48,996
TERTIARY IS TESTING FOR 

853
00:41:48,996 --> 00:41:49,597
ANTIBODY-BASED PRODUCTS AND 

854
00:41:49,597 --> 00:41:52,833
OTHER CHANGING CONDITIONS OF THE

855
00:41:52,833 --> 00:41:56,470
CULTURE.

856
00:41:56,470 --> 00:41:58,706
CY

857
00:41:58,706 --> 00:41:59,273
CY

858
00:41:59,273 --> 00:42:01,142
CY

859
00:42:01,142 --> 00:42:01,809
CY

860
00:42:01,809 --> 00:42:04,712
CY

861
00:42:04,712 --> 00:42:07,181
CY

862
00:42:07,181 --> 00:42:07,581
CY

863
00:42:07,581 --> 00:42:08,983
CYTOTOXICITY FOR TESTING AND 

864
00:42:08,983 --> 00:42:16,924
INTO IN VIVO STUDIES.

865
00:42:16,924 --> 00:42:21,128
SO IN TERMS OF THE VOLUME OF 

866
00:42:21,128 --> 00:42:24,198
THIS TESTING AS WELL AS AN 

867
00:42:24,198 --> 00:42:28,703
EXAMPLE OF SUCCESS FROM 2019 TO 

868
00:42:28,703 --> 00:42:30,905
2024 WERE REQUESTS FROM ALMOST 

869
00:42:30,905 --> 00:42:32,306
1,000 UNIQUE REQUESTERS.

870
00:42:32,306 --> 00:42:34,709
MORE THAN 5,000 PRODUCTS HAVE 

871
00:42:34,709 --> 00:42:36,877
BEEN TESTED IN THIS TIME FRAME.

872
00:42:36,877 --> 00:42:38,112
AS MENTIONED TESTING IS 

873
00:42:38,112 --> 00:42:40,614
ORGANIZED INTO TIERS.

874
00:42:40,614 --> 00:42:43,451
AND IT'S REPRESENTED HERE 

875
00:42:43,451 --> 00:42:45,453
OBVIOUSLY MANY MORE PRIMATES 

876
00:42:45,453 --> 00:42:46,721
TESTED.

877
00:42:46,721 --> 00:42:49,724
YOU CAN SEE A FEW CAN GRADUATE 

878
00:42:49,724 --> 00:42:53,127
TO SECONDARY TESTING.

879
00:42:53,127 --> 00:42:55,830
76 ANTIVIRAL PRODUCTS MOVED ON 

880
00:42:55,830 --> 00:43:01,135
TO IN VIVO TESTING UNDER THE 

881
00:43:01,135 --> 00:43:02,937
OTHER PCS CONTRACTS.

882
00:43:02,937 --> 00:43:07,408
IN 2015 AT THE MID POINT OF THE 

883
00:43:07,408 --> 00:43:09,510
LAST ITERATION OF THE CONTRACT 

884
00:43:09,510 --> 00:43:10,578
PROGRAM ALMOST THE EXACT NUMBER 

885
00:43:10,578 --> 00:43:12,446
OF PRODUCTS HAD BEEN TESTED AND 

886
00:43:12,446 --> 00:43:15,416
GONE TO IN VIVO STUDIES WHICH 

887
00:43:15,416 --> 00:43:17,218
REPRESENTS THE CONSISTENCY OF 

888
00:43:17,218 --> 00:43:18,119
THE PROGRAM.

889
00:43:18,119 --> 00:43:21,122
THE CONSISTENCY AND DEMAND ON 

890
00:43:21,122 --> 00:43:25,126
THE PROGRAM.

891
00:43:25,126 --> 00:43:35,669
SO ONE AND ONE IS CYCLOPROPAVIR 

892
00:43:39,407 --> 00:43:41,142
AND MESSED ON TO IN VIVO STUDIES

893
00:43:41,142 --> 00:43:43,711
UNDER ANOTHER CONTRACT PROGRAM 

894
00:43:43,711 --> 00:43:49,150
AND WAS FOUND PROMISE BEING FOR 

895
00:43:49,150 --> 00:43:51,185
MULTIPLE INDICATIONS.

896
00:43:51,185 --> 00:43:52,920
THIS SUCCESSFULLY COMPLETED 

897
00:43:52,920 --> 00:43:54,522
PHASE I TRIAL AND THERE'S PLANS 

898
00:43:54,522 --> 00:43:59,860
TO MOVE IT INTO A PHASE II TRIAL

899
00:43:59,860 --> 00:44:02,596
FOR TRANSPLANT RECIPIENTS.

900
00:44:02,596 --> 00:44:04,698
THIS IS NOT YET IN CLINICAL 

901
00:44:04,698 --> 00:44:06,934
TRIALS.gov BUT STATED GOAL OF 

902
00:44:06,934 --> 00:44:08,502
THE PRODUCT SPONSOR.

903
00:44:08,502 --> 00:44:10,171
ANOTHER STATED GOAL IS TO PURSUE

904
00:44:10,171 --> 00:44:14,041
CLINICAL DEVELOPMENT FOR 

905
00:44:14,041 --> 00:44:17,978
ADENOVIRUS IN HUMAN HERPES VIRUS

906
00:44:17,978 --> 00:44:20,881
VI INDICATIONS.

907
00:44:20,881 --> 00:44:22,583
IT'S A BROAD SPECTRUM.

908
00:44:22,583 --> 00:44:25,119
I MUST MENTIONED THE IN VIVO 

909
00:44:25,119 --> 00:44:28,522
RESPONSE TO SARS COV2.

910
00:44:28,522 --> 00:44:31,892
CONTRACTS OFFER FLEXIBILITY TO 

911
00:44:31,892 --> 00:44:35,596
PIVOT QUICKLY TO ADDRESS MENTAL 

912
00:44:35,596 --> 00:44:36,330
HEALTH EMERGENCIES LIKE THE 

913
00:44:36,330 --> 00:44:40,134
COVID PANDEMIC AND STARTING IN 

914
00:44:40,134 --> 00:44:41,268
2020 WAS ABLE TO RESPOND TO THE 

915
00:44:41,268 --> 00:44:42,970
DEMANDS OF THE PANDEMIC.

916
00:44:42,970 --> 00:44:46,707
TO DATE 91 PRODUCTS WITH 46 

917
00:44:46,707 --> 00:44:49,543
REQUESTERS HAVE BEEN TESTED 

918
00:44:49,543 --> 00:44:51,078
SPECIFICALLY AGAINST SARS COV2.

919
00:44:51,078 --> 00:44:52,680
OF THESE 21 MOVED ON TO TESTING 

920
00:44:52,680 --> 00:44:54,248
IN SMALL AN PLAL MODELS OF COVID

921
00:44:54,248 --> 00:45:03,324
INFECTION.

922
00:45:03,324 --> 00:45:09,063
I WANT TO THANK DOCTORS ESTES 

923
00:45:09,063 --> 00:45:14,969
AND PALMER REMARKING ON THE 

924
00:45:14,969 --> 00:45:15,436
SERVICE.

925
00:45:15,436 --> 00:45:16,337
BOTH IMPRESSED BY THE BROAD 

926
00:45:16,337 --> 00:45:19,740
SCOPE OF PATHOGENS COVERED IF 

927
00:45:19,740 --> 00:45:20,541
THE CONTRACT.

928
00:45:20,541 --> 00:45:22,710
THE LIBRARY AND CHEMICAL ENTITY 

929
00:45:22,710 --> 00:45:24,211
COLLECTION IS OF PARTICULAR 

930
00:45:24,211 --> 00:45:26,847
VALUE AND WORTHY OF INCREASED 

931
00:45:26,847 --> 00:45:27,281
MESSING.

932
00:45:27,281 --> 00:45:29,550
BOTH DISCUSSED THE METRICS WE 

933
00:45:29,550 --> 00:45:31,318
USED TO DETERMINE THE SUCCESS OF

934
00:45:31,318 --> 00:45:33,120
THE PROGRAM AND HOW WE DECIDED 

935
00:45:33,120 --> 00:45:36,724
TO MOVE FORWARD WITH TESTING A 

936
00:45:36,724 --> 00:45:37,625
PARTICULAR ENTITY.

937
00:45:37,625 --> 00:45:38,526
THE SPONSORS WHO REQUEST 

938
00:45:38,526 --> 00:45:40,728
SERVICES AND THE TYPICAL AMOUNT 

939
00:45:40,728 --> 00:45:42,997
OF TIME NEEDED TO AWARD SCORERS.

940
00:45:42,997 --> 00:45:44,665
AGAIN, THIS IS A RAPID TURN 

941
00:45:44,665 --> 00:45:46,534
AROUND SO THAT WAS OF INTEREST 

942
00:45:46,534 --> 00:45:47,301
AS WELL.

943
00:45:47,301 --> 00:45:49,136
DR. PALMER NOTED THE FLEXIBILITY

944
00:45:49,136 --> 00:45:53,440
AND RAPID RESPONSIVENESS ARE 

945
00:45:53,440 --> 00:45:56,010
ESSENTIAL ELEMENTS OF THE 

946
00:45:56,010 --> 00:45:58,512
PROGRAM FOR ADDRESSING PUBLIC 

947
00:45:58,512 --> 00:46:01,015
HEALTH EMERGENCIES AND PROVIDING

948
00:46:01,015 --> 00:46:04,385
RESULTS FOR PRODUCT DEVELOPERS 

949
00:46:04,385 --> 00:46:10,724
ON IN TIME GO/NO-GO PERFORMANCE 

950
00:46:10,724 --> 00:46:14,862
AND WERE SUPPORTIVE EFFORTS AND 

951
00:46:14,862 --> 00:46:16,964
ACKNOWLEDGED THE DRUG 

952
00:46:16,964 --> 00:46:19,366
DEVELOPMENT IN THE AREA LAGS 

953
00:46:19,366 --> 00:46:20,401
BETWEEN ANTIBACTERIAL AND 

954
00:46:20,401 --> 00:46:21,135
ANTIBIOTIC DEVELOPMENT.

955
00:46:21,135 --> 00:46:22,570
RETURNING TO THE CONCEPT SLIDE 

956
00:46:22,570 --> 00:46:23,070
I'M HAPPY TO ANSWER ANY 

957
00:46:23,070 --> 00:46:33,247
QUESTIONS.

958
00:46:44,258 --> 00:46:47,561
>> ANY QUESTIONS OR
COMMENTS?

959
00:46:47,561 --> 00:46:49,129
VERY CLEAR AND COMPREHENSIVE 

960
00:46:49,129 --> 00:46:56,503
APPARENTLY.

961
00:46:56,503 --> 00:46:58,706
SO WE'RE MOVING EFFICIENTLY THIS

962
00:46:58,706 --> 00:46:59,139
AFTERNOON.

963
00:46:59,139 --> 00:47:02,109
OUR NEXT CONCEPT WILL BE 

964
00:47:02,109 --> 00:47:03,677
PRESENTED BY MICHELLE ARNOLD 

965
00:47:03,677 --> 00:47:04,445
FROM THE RESPIRATORY DISEASE 

966
00:47:04,445 --> 00:47:05,012
BRANCH.

967
00:47:05,012 --> 00:47:06,880
>> THANK YOU FOR THE
OPPORTUNITY

968
00:47:06,880 --> 00:47:09,116
TO PRESENT THIS INITIATIVE WHICH

969
00:47:09,116 --> 00:47:11,752
IS TITLED THE IMPACT OF INITIAL 

970
00:47:11,752 --> 00:47:12,419
INFLUENZA EXPOSURE ON IMMUNITY 

971
00:47:12,419 --> 00:47:22,630
AND INFANTS.

972
00:47:26,734 --> 00:47:29,103
THE OBJECTIVE IS TO DETERMINE 

973
00:47:29,103 --> 00:47:33,140
HOW INFLUENZA INFECTIONS OR 

974
00:47:33,140 --> 00:47:34,108
VACCINES SHAPES PROTECTIVE 

975
00:47:34,108 --> 00:47:36,644
IMMUNITY TO FUTURE EXPOSURES IN 

976
00:47:36,644 --> 00:47:37,745
LONGITUDINAL HUMAN INFANT 

977
00:47:37,745 --> 00:47:38,379
COHORTS.

978
00:47:38,379 --> 00:47:40,614
THIS IS A RENEWAL INITIATIVE 

979
00:47:40,614 --> 00:47:42,116
FIRST ESTABLISHED IN 2008.

980
00:47:42,116 --> 00:47:44,251
THERE ARE CURRENTLY TWO ACTIVE 

981
00:47:44,251 --> 00:47:46,186
AWARDS BUT THIS WILL BE AN OPEN 

982
00:47:46,186 --> 00:47:47,254
COMPETITION TO ALLOW RESEARCH 

983
00:47:47,254 --> 00:47:50,758
TEAMS TO PROPOSE NEW OR 

984
00:47:50,758 --> 00:47:52,526
CONTINUING SUPPORT OF EXISTING 

985
00:47:52,526 --> 00:47:56,563
INFLUENZA INFANT COHORTS.

986
00:47:56,563 --> 00:47:58,732
AT LEAST TWO UL 1 COOPERATIVE 

987
00:47:58,732 --> 00:48:00,968
AGREEMENTS ARE EXPECTED IN 

988
00:48:00,968 --> 00:48:02,503
FISCAL 26 AND CO-MANAGED BETWEEN

989
00:48:02,503 --> 00:48:05,039
THE DIVISION OF MICROBIOLOGY AND

990
00:48:05,039 --> 00:48:09,310
INFECTIOUS DISEASES AND ALLERGY,

991
00:48:09,310 --> 00:48:12,880
IMMUNOLOGY AND TRANSPLANTATION.

992
00:48:12,880 --> 00:48:15,149
A CHILD'S FIRST EXPOSURE TO 

993
00:48:15,149 --> 00:48:15,983
INFLUENZA BY INFECTION OR 

994
00:48:15,983 --> 00:48:18,452
VACCINATION LEADS TO THE PRODUCT

995
00:48:18,452 --> 00:48:20,954
OF ANTIBODIES AND MEMORY B CELLS

996
00:48:20,954 --> 00:48:25,125
THAT RECOGNIZE ANTIGENIC 

997
00:48:25,125 --> 00:48:32,132
EPITOPINGSS  -- EPITOPES AND TH 

998
00:48:32,132 --> 00:48:33,967
MEMORY B CELLS ARE ESSENTIAL TO 

999
00:48:33,967 --> 00:48:38,439
RESPONDING TO FUTURE INFECTIONS.

1000
00:48:38,439 --> 00:48:39,606
INFLUENZA VIRUSES MUTATE AND 

1001
00:48:39,606 --> 00:48:41,942
CHANGE OVER TIME RESULTING IN 

1002
00:48:41,942 --> 00:48:44,044
DIFFERENCES TO THE SURFACE 

1003
00:48:44,044 --> 00:48:44,311
PROTEINS.

1004
00:48:44,311 --> 00:48:46,747
EXPOSURE TO A RELATED ANTIGEN 

1005
00:48:46,747 --> 00:48:49,883
FROM A SECOND OR THIRD INFLUENZA

1006
00:48:49,883 --> 00:48:51,285
INFECTION LEADS TO A MIXED 

1007
00:48:51,285 --> 00:48:54,154
PRIMARY AND RECALL IMPRINTED 

1008
00:48:54,154 --> 00:48:54,755
IMMUNE RESPONSE.

1009
00:48:54,755 --> 00:48:58,192
THE PRIMARY RESPONSE TO THE NEW 

1010
00:48:58,192 --> 00:48:59,226
ANTIGEN EXPOSURE IS LESS 

1011
00:48:59,226 --> 00:49:01,962
EFFICIENT AND OVERWHELMED BY THE

1012
00:49:01,962 --> 00:49:04,598
RAPID AND ROBUST MEMORY B CELL 

1013
00:49:04,598 --> 00:49:07,735
CALL RESPONSE TO THE ANTIGENS.

1014
00:49:07,735 --> 00:49:10,137
THUS THE IMPRINTED ANTIBODY 

1015
00:49:10,137 --> 00:49:14,274
RESPONSE IS MORE ROBUST THAN THE

1016
00:49:14,274 --> 00:49:15,342
NEW ANTIGEN.

1017
00:49:15,342 --> 00:49:20,080
HUMANS REMAIN THE PATTERN OF 

1018
00:49:20,080 --> 00:49:20,714
HEIGHTENED REACTIVITY AGAINST 

1019
00:49:20,714 --> 00:49:22,816
INFLUENZA VIRUS CIRCULATED 

1020
00:49:22,816 --> 00:49:24,618
DURING THE CHILDHOOD.

1021
00:49:24,618 --> 00:49:27,988
WHILE THE RESPONSE IS KNOWN TO 

1022
00:49:27,988 --> 00:49:31,058
OCCUR FOR VIRUSES LIKE INFLUENZA

1023
00:49:31,058 --> 00:49:35,295
AND SARS COV2 COULD BE 

1024
00:49:35,295 --> 00:49:35,896
APPLICABLE TO OTHER MUCOSAL 

1025
00:49:35,896 --> 00:49:43,737
PATHOGENS.

1026
00:49:43,737 --> 00:49:49,109
AND TO THE FIRST EXPOSURE WORKS 

1027
00:49:49,109 --> 00:49:57,117
WITH AND IS IMPRINTING CAN BE 

1028
00:49:57,117 --> 00:50:00,187
HARNESSED TO MAKE VACCINES FOR 

1029
00:50:00,187 --> 00:50:05,793
INDIVIDUALS OR DO THE EFFECTS 

1030
00:50:05,793 --> 00:50:07,494
NEED TO HAVE MORE EFFECTIVE AND 

1031
00:50:07,494 --> 00:50:10,631
DURABLE VACCINES FOR ADULTS.

1032
00:50:10,631 --> 00:50:14,868
UNDERSTANDING IMPRINTING IS THE 

1033
00:50:14,868 --> 00:50:15,702
IMPORTANT OBJECTIVE OF THE 

1034
00:50:15,702 --> 00:50:17,137
INFLUENZA STRATEGIC PLAN 

1035
00:50:17,137 --> 00:50:20,741
SPECIFICALLY OBJECTIVE 2.1 WHICH

1036
00:50:20,741 --> 00:50:23,610
AIMS TO UNDERSTAND HOW AND WHEN 

1037
00:50:23,610 --> 00:50:26,280
EXPOSURE TO INFLUENZA ANTIGENS 

1038
00:50:26,280 --> 00:50:28,315
SHAPE THE HOST RESPONSE TO 

1039
00:50:28,315 --> 00:50:28,816
INFLUENZA INFECTION AND 

1040
00:50:28,816 --> 00:50:32,553
VACCINATION.

1041
00:50:32,553 --> 00:50:34,721
THE CURRENT AWARDS IN THE 

1042
00:50:34,721 --> 00:50:38,158
PORTFOLIO ALSO CONTRIBUTE TO THE

1043
00:50:38,158 --> 00:50:39,326
CROSS-CUTTING TOOLS TO IMPROVE 

1044
00:50:39,326 --> 00:50:43,197
INFLUENZA VACCINES BY 

1045
00:50:43,197 --> 00:50:45,966
ESTABLISHING LONGITUDINAL 

1046
00:50:45,966 --> 00:50:47,334
COHORTS FOR INFLUENZA RESEARCH.

1047
00:50:47,334 --> 00:50:48,735
APPLICATION TO THE FIRST NOTICE 

1048
00:50:48,735 --> 00:50:51,438
OF FUNDING OPPORTUNITY WERE 

1049
00:50:51,438 --> 00:50:55,676
REVIEWED AND RECEIVED IN 2018.

1050
00:50:55,676 --> 00:50:57,110
TWO COOPERATIVE AGREEMENTS WERE 

1051
00:50:57,110 --> 00:50:58,912
AWARDED IN APRIL OF 2019.

1052
00:50:58,912 --> 00:51:01,114
THESE WERE SEVEN-YEAR AWARDS TO 

1053
00:51:01,114 --> 00:51:04,251
ENABLE THE ESTABLISHMENT OF 

1054
00:51:04,251 --> 00:51:08,288
COHORTS AND TO TIME TO PROVIDE 

1055
00:51:08,288 --> 00:51:10,524
TWO OR MORE EXPOSURES TO 

1056
00:51:10,524 --> 00:51:12,292
INFLUENZA EITHER BY VACCINATION 

1057
00:51:12,292 --> 00:51:13,026
OR INFECTION.

1058
00:51:13,026 --> 00:51:15,996
THE UNANTICIPATED SARS COV2 

1059
00:51:15,996 --> 00:51:18,332
PANDEMIC EARLY IN THE AWARD 

1060
00:51:18,332 --> 00:51:20,133
RESULTS IN FEW INFLUENZA CASES 

1061
00:51:20,133 --> 00:51:24,037
IN 2020 TO 2021 AS WELL AS THE 

1062
00:51:24,037 --> 00:51:25,939
2021 TO 2022 SEASONS.

1063
00:51:25,939 --> 00:51:29,109
THE ABSENCE OF INFLUENZA 

1064
00:51:29,109 --> 00:51:30,978
INFECTIONS INITIALLY AFFECTED 

1065
00:51:30,978 --> 00:51:34,681
THE ENROLLMENT OF PARTICIPANTS 

1066
00:51:34,681 --> 00:51:36,517
EXPOSED BUT WITH RESEARCH FROM 

1067
00:51:36,517 --> 00:51:40,454
THE PROGRAMS CONTRIBUTED TO 

1068
00:51:40,454 --> 00:51:42,856
UNDERSTANDING SARS COV2 EARLY IN

1069
00:51:42,856 --> 00:51:47,060
THE PANDEMIC AND THEY HAVE 

1070
00:51:47,060 --> 00:51:48,795
RECRUITED MORE PARTICIPANTS THAN

1071
00:51:48,795 --> 00:51:49,496
PLANNED TO PARTICIPATE IN THE 

1072
00:51:49,496 --> 00:51:53,400
ORIGINAL STUDY DESIGN.

1073
00:51:53,400 --> 00:51:54,835
THE CURRENT COOPERATIVE 

1074
00:51:54,835 --> 00:52:00,240
AGREEMENT THE DA VINCI OR 

1075
00:52:00,240 --> 00:52:02,442
DISSECTION OF THE IMMUNITY 

1076
00:52:02,442 --> 00:52:06,146
AWARDED TO PAUL TOMS AT ST. JUDE

1077
00:52:06,146 --> 00:52:07,014
CHILDREN'S RESEARCH HOSPITAL AND

1078
00:52:07,014 --> 00:52:07,848
UNIVERSITY OF MICHIGAN.

1079
00:52:07,848 --> 00:52:09,449
THE SECOND STUDY IS THE IMPACT 

1080
00:52:09,449 --> 00:52:12,686
OR IMPACT OF THE INITIAL 

1081
00:52:12,686 --> 00:52:14,221
INFLUENZA EXPOSURE ON THE 

1082
00:52:14,221 --> 00:52:17,958
QUALITY, MAGNITUDE, BREADTH, 

1083
00:52:17,958 --> 00:52:22,329
POTENCY AND IMMUNITY AWARDED TO 

1084
00:52:22,329 --> 00:52:24,097
MARY STAT AT CINCINNATI 

1085
00:52:24,097 --> 00:52:24,731
CHILDREN'S HOSPITAL.

1086
00:52:24,731 --> 00:52:27,801
THE DA VINCI STUDY COHORT HAVE A

1087
00:52:27,801 --> 00:52:30,571
TOTAL ENROLLMENT OF 

1088
00:52:30,571 --> 00:52:31,238
APPROXIMATELY 2100 CHILDREN 

1089
00:52:31,238 --> 00:52:34,641
ACROSS THE COHORTS INCLUDING 

1090
00:52:34,641 --> 00:52:37,945
NICARAGUA COVERING THE SOUTHERN 

1091
00:52:37,945 --> 00:52:39,012
HEMISPHERE, NEW ZEALAND COVERING

1092
00:52:39,012 --> 00:52:41,815
A TROPICAL LOCATION AND SOUTHERN

1093
00:52:41,815 --> 00:52:42,783
CALIFORNIA WHICH COVERS THE 

1094
00:52:42,783 --> 00:52:43,951
NORTHERN HEMISPHERE.

1095
00:52:43,951 --> 00:52:46,753
THIS ALLOWS FOR YEAR ROUND 

1096
00:52:46,753 --> 00:52:47,588
SAMPLE COLLECTION AND COVERAGE 

1097
00:52:47,588 --> 00:52:51,758
OF INFECTIONS AND VACCINATION 

1098
00:52:51,758 --> 00:52:52,025
EXPOSURES.

1099
00:52:52,025 --> 00:52:53,760
THE SITE OF NICARAGUA HAS A 

1100
00:52:53,760 --> 00:53:00,434
COHORT THAT BEGAN IN 2011 RAAND 

1101
00:53:00,434 --> 00:53:04,771
HAS AN ACTIVE ENROLLMENT OF 

1102
00:53:04,771 --> 00:53:05,939
1,248 WITH 181 PARTICIPANTS 

1103
00:53:05,939 --> 00:53:07,374
CONFIRMED TO HAVE MORE THAN ONE 

1104
00:53:07,374 --> 00:53:10,577
EXPOSURE TO INFLUENZA.

1105
00:53:10,577 --> 00:53:14,114
THE NEW ZEALAND SITE AN ACTIVE 

1106
00:53:14,114 --> 00:53:16,783
ENROLLMENT OF 652 CHILDREN WITH 

1107
00:53:16,783 --> 00:53:17,484
228 PARTICIPANTS CONFIRMED TO 

1108
00:53:17,484 --> 00:53:20,320
HAVE MORE THAN ONE EXPOSURE.

1109
00:53:20,320 --> 00:53:21,021
AND THE SOUTHERN CLINICAL 

1110
00:53:21,021 --> 00:53:24,658
RESEARCH SITE HAS AN ACTIVE 

1111
00:53:24,658 --> 00:53:28,095
ENROLLMENT OF 230 WITH 125 

1112
00:53:28,095 --> 00:53:28,695
CONFIRMED SECOND EXPOSURES IN 

1113
00:53:28,695 --> 00:53:39,172
THE CASE ALL BY VACCINATION.

1114
00:53:39,640 --> 00:53:41,541
THE SITE IN MEXICO HAS AN 

1115
00:53:41,541 --> 00:53:45,679
ENROLLMENT OF 790 AND THE SITE 

1116
00:53:45,679 --> 00:53:48,215
IN CINCINNATI HAS 1,490 

1117
00:53:48,215 --> 00:53:49,116
ENROLLEES.

1118
00:53:49,116 --> 00:53:52,452
THE INCLUSION OF MOTHER-CHILD 

1119
00:53:52,452 --> 00:53:54,488
PAIRS ALLOWS FOR THE ADDITIONAL 

1120
00:53:54,488 --> 00:53:56,089
CONSIDERATION OF MATERNALLY 

1121
00:53:56,089 --> 00:53:56,823
TRANSFERRED ANTIBODY.

1122
00:53:56,823 --> 00:54:00,227
THE LARGE COHORTS ARE NECESSARY 

1123
00:54:00,227 --> 00:54:01,428
TO COLLECT STATISTICALLY 

1124
00:54:01,428 --> 00:54:03,163
SIGNIFICANT NUMBER OF SECOND AND

1125
00:54:03,163 --> 00:54:04,231
THIRD EXPOSURES IN ORDER TO 

1126
00:54:04,231 --> 00:54:06,266
UNDERSTAND THE EFFECTS OF 

1127
00:54:06,266 --> 00:54:06,566
IMPRINTING.

1128
00:54:06,566 --> 00:54:09,002
AND THERE MAY BE DIFFERENCES TO 

1129
00:54:09,002 --> 00:54:10,070
DISCOVER DEPENDING ON WHETHER 

1130
00:54:10,070 --> 00:54:12,572
THE FIRST AND SECOND EXPOSURES 

1131
00:54:12,572 --> 00:54:13,240
WERE EITHER BY VACCINATION OR BY

1132
00:54:13,240 --> 00:54:17,210
INFECTION.

1133
00:54:17,210 --> 00:54:21,081
AS THE COHORTS ENROLL AND FOLLOW

1134
00:54:21,081 --> 00:54:24,251
PARTICIPANTS THEY'RE COLLECTING 

1135
00:54:24,251 --> 00:54:28,522
SAMPLES AND IN DEPTH ANALYSIS OF

1136
00:54:28,522 --> 00:54:29,956
ANTIBODY B CELL AND T CELL 

1137
00:54:29,956 --> 00:54:30,223
RESPONSES.

1138
00:54:30,223 --> 00:54:31,358
THESE CURRENTLY ARE UNDERWAY 

1139
00:54:31,358 --> 00:54:34,661
WITH CONFIRMED CASES OF FIRST 

1140
00:54:34,661 --> 00:54:36,096
AND SECOND EXPOSURES TO 

1141
00:54:36,096 --> 00:54:36,697
INFLUENZA VIRUS.

1142
00:54:36,697 --> 00:54:40,667
THE COMPREHENSIVE PANEL OF 

1143
00:54:40,667 --> 00:54:42,536
ASSAYS WILL OFFER A DETAIL LEVEL

1144
00:54:42,536 --> 00:54:44,738
OF CHARACTERIZATION AND PROVIDE 

1145
00:54:44,738 --> 00:54:51,745
AN UNPRECEDENTED DEGREE OF 

1146
00:54:51,745 --> 00:54:52,279
RESOLUTIONS.

1147
00:54:52,279 --> 00:54:53,480
THE OUTCOMES ARE ESSENTIAL FOR 

1148
00:54:53,480 --> 00:54:55,215
DETERMINING THE IMPACT OF FIRST 

1149
00:54:55,215 --> 00:54:59,886
EXPOSURE ON THE IMMUNE RESPONSES

1150
00:54:59,886 --> 00:55:01,922
ON THE CELLULAR AND ANTIBODY 

1151
00:55:01,922 --> 00:55:03,056
RESPONSES TO SUBSEQUENT 

1152
00:55:03,056 --> 00:55:03,824
EXPOSURES.

1153
00:55:03,824 --> 00:55:05,025
GIVEN THE COMPLEXITY OF THE 

1154
00:55:05,025 --> 00:55:06,359
EXPOSURES, THESE FINDINGS ARE 

1155
00:55:06,359 --> 00:55:09,262
LIKELY TO BE ITERATIVE AS THE 

1156
00:55:09,262 --> 00:55:10,230
ANALYSES EXPAND WITH THE 

1157
00:55:10,230 --> 00:55:11,565
INCREASING NUMBER OF SAMPLES 

1158
00:55:11,565 --> 00:55:15,202
BEING EVALUATED.

1159
00:55:15,202 --> 00:55:18,271
RESEARCH FROM THE DA VINCI STUDY

1160
00:55:18,271 --> 00:55:20,707
CONTRIBUTED TO 70 PUBLICATIONS 

1161
00:55:20,707 --> 00:55:24,010
INCLUDING HIGH IMPACT 

1162
00:55:24,010 --> 00:55:27,214
PUBLICATIONS ON THE NICARAGUAN 

1163
00:55:27,214 --> 00:55:36,056
COHORTS PUBLISHED IN CLINICAL, 

1164
00:55:36,056 --> 00:55:41,728
INFECTIOUS DISEASES AND 

1165
00:55:41,728 --> 00:55:43,063
CORRELATES INDEPENDENT OF 

1166
00:55:43,063 --> 00:55:46,767
SEROLOGY AND IMMUNOLOGY AND 

1167
00:55:46,767 --> 00:55:49,536
BASAL STATE AND IMPLICATIONS FOR

1168
00:55:49,536 --> 00:55:49,936
DISEASE.

1169
00:55:49,936 --> 00:55:51,972
RESEARCH FROM THE IMPRINT STUDY 

1170
00:55:51,972 --> 00:55:54,641
CONTRIBUTED TO 11 PUBLICATIONS 

1171
00:55:54,641 --> 00:55:55,942
INCLUDING MULTI-OMICS ANALYSIS 

1172
00:55:55,942 --> 00:55:58,779
OF MUCOSAL AND SYSTEMIC IMMUNITY

1173
00:55:58,779 --> 00:56:01,114
OF SARS COV2 AFTER BIRTH IN THE 

1174
00:56:01,114 --> 00:56:05,285
CELL AND A STUDY OF THE FACTORS 

1175
00:56:05,285 --> 00:56:08,054
WITH PROLONGED VIRUS PROTECTION 

1176
00:56:08,054 --> 00:56:11,491
WITH PCR OF NASAL SPECIMENS 

1177
00:56:11,491 --> 00:56:13,693
COLLECTED LONGITUDINALLY IN 

1178
00:56:13,693 --> 00:56:14,895
HEALTHY CHILDREN IN A 

1179
00:56:14,895 --> 00:56:17,564
U.S. COHORT IN THE JOURNAL OF 

1180
00:56:17,564 --> 00:56:19,132
THE PEDIATRIC INFECTIOUS 

1181
00:56:19,132 --> 00:56:20,901
DISEASES SOCIETY.

1182
00:56:20,901 --> 00:56:23,503
THE RENEWAL OF THIS INITIATIVE 

1183
00:56:23,503 --> 00:56:25,772
NOW PROPOSES FIVE-YEAR AWARDS 

1184
00:56:25,772 --> 00:56:28,775
WHICH ARE EXPECTED TO SUPPORT 

1185
00:56:28,775 --> 00:56:29,376
THE ESTABLISHMENT OR 

1186
00:56:29,376 --> 00:56:33,446
CONTINUATION OF INFANT COHORTS 

1187
00:56:33,446 --> 00:56:36,750
TO DETERMINE HOW INITIAL NATURAL

1188
00:56:36,750 --> 00:56:40,620
INFLUENZA EXPOSURE OR 

1189
00:56:40,620 --> 00:56:44,524
VACCINATION SHAPES IMMUNE 

1190
00:56:44,524 --> 00:56:47,761
REASONS TO SUBSEQUENT EXPOSURES.

1191
00:56:47,761 --> 00:56:49,496
PROSPECTIVE COHORTS WILL BE 

1192
00:56:49,496 --> 00:56:51,631
FOLLOWED PRIOR TO AND AFTER 

1193
00:56:51,631 --> 00:56:52,833
RECEIVING THE INITIAL INFLUENZA 

1194
00:56:52,833 --> 00:56:53,967
VACCINATIONS OR AFTER THE 

1195
00:56:53,967 --> 00:56:56,169
CLINICAL DIAGNOSIS OF INFLUENZA 

1196
00:56:56,169 --> 00:56:58,371
INFECTION PRIOR TO RECEIVING AN 

1197
00:56:58,371 --> 00:57:06,279
INITIAL INFLUENZA VACCINATION.

1198
00:57:06,279 --> 00:57:08,315
RESEARCH PLANS ARE EXPECTED TO 

1199
00:57:08,315 --> 00:57:10,817
ADDRESS THE EFFECTS OF REPEATED 

1200
00:57:10,817 --> 00:57:12,552
EXPOSURES TO INFECTIONS OR 

1201
00:57:12,552 --> 00:57:20,026
VACCINATIONS ON THE MAINTENANCE 

1202
00:57:20,026 --> 00:57:28,535
ON IMMUNITY IN INFANTS AND 

1203
00:57:28,535 --> 00:57:32,639
CHILDREN AND LOOK AT VACCINATION

1204
00:57:32,639 --> 00:57:35,442
VERSUS NATURAL INFECTION AND 

1205
00:57:35,442 --> 00:57:39,512
TAKE OTHER VACCINATIONS INTO 

1206
00:57:39,512 --> 00:57:40,180
CONSIDERATION BUT STILL MEASURE 

1207
00:57:40,180 --> 00:57:46,820
RESPONSE TO INFLUENZA.

1208
00:57:46,820 --> 00:57:48,989
I WOULD LIKE TO THANK THE 

1209
00:57:48,989 --> 00:57:50,123
COUNCIL MEMBERS WHO REVIEWED 

1210
00:57:50,123 --> 00:57:53,927
THIS FOR THEIR TIME AND 

1211
00:57:53,927 --> 00:57:54,361
COMMENTS.

1212
00:57:54,361 --> 00:57:57,864
AND NOTED RESEARCH PROGRAMS TO 

1213
00:57:57,864 --> 00:57:58,632
UNDERSTAND EARLY IMMUNE 

1214
00:57:58,632 --> 00:58:08,208
RESPONSES IN KNEEE JONIOO -- 

1215
00:58:08,208 --> 00:58:10,977
SUPPORTED SUPPORT FOR COHORT 

1216
00:58:10,977 --> 00:58:13,446
STUDIES PROVIDES FOUNDATIONAL 

1217
00:58:13,446 --> 00:58:15,181
INFORMATION TO IMPROVE IMMUNE 

1218
00:58:15,181 --> 00:58:24,157
HEALTH AND VACCINE EFFICACY.

1219
00:58:24,157 --> 00:58:25,258
I APPRECIATE THE SUPPORT ON THE 

1220
00:58:25,258 --> 00:58:31,064
AND I CAN TAKE ANY QUESTIONS.

1221
00:58:31,064 --> 00:58:31,698
>> ANY QUESTIONS OR
ADDITIONAL 

1222
00:58:31,698 --> 00:58:33,166
COMMENTS?

1223
00:58:33,166 --> 00:58:34,000
>> I'LL COMMENT.

1224
00:58:34,000 --> 00:58:36,770
I THINK IT'S AMAZING FOR ALL THE

1225
00:58:36,770 --> 00:58:38,138
YEARS WE'VE STUDIED INFLUENZA 

1226
00:58:38,138 --> 00:58:40,507
AND ALL THE RESEARCH THAT'S BEEN

1227
00:58:40,507 --> 00:58:46,680
DONE WE STILL DON'T REALLY 

1228
00:58:46,680 --> 00:58:47,948
UNDERSTAND WHAT HAPPENS WITH 

1229
00:58:47,948 --> 00:58:49,683
IMPRINTING FROM THE FIRST 

1230
00:58:49,683 --> 00:58:50,650
INFECTION AND VACCINATION.

1231
00:58:50,650 --> 00:58:51,418
I THINK IT'S A VERY IMPORTANT 

1232
00:58:51,418 --> 00:59:01,528
STUDY.

1233
00:59:08,768 --> 00:59:12,839
>> MOVING ON TO THE NEXT 

1234
00:59:12,839 --> 00:59:14,074
CONCEPT, MICHAEL ISON FROM THE 

1235
00:59:14,074 --> 00:59:16,843
RESPIRATORY DISEASE BRANCHING.

1236
00:59:16,843 --> 00:59:25,118
-- BRANCH..

1237
00:59:25,118 --> 00:59:25,585
-- BRANCH.

1238
00:59:25,585 --> 00:59:31,624
>> IT'S MY HONOR TO TALK
ABOUT 

1239
00:59:31,624 --> 00:59:36,262
THE COLLABORATIVE INFLUENZA 

1240
00:59:36,262 --> 00:59:37,864
VACCINE INNOVATION CENTER THE 

1241
00:59:37,864 --> 00:59:43,203
CIVICS PROGRAM IS TO ADVANCE 

1242
00:59:43,203 --> 00:59:44,938
IMPROVEMENTS ON SEASONAL VACCINE

1243
00:59:44,938 --> 00:59:48,141
AS WELL AS ACHIEVE OUR LONG-TERM

1244
00:59:48,141 --> 00:59:56,816
GOAL OF UNIVERSAL INFLUENZA 

1245
00:59:56,816 --> 00:59:57,050
VACCINE.

1246
00:59:57,050 --> 00:59:57,717
MOVE THEM THROUGH MANUFACTURING 

1247
00:59:57,717 --> 00:59:59,819
AND INTO THE CLINIC AND TAKE THE

1248
00:59:59,819 --> 01:00:04,224
DATA THAT IS GENERATED FROM THAT

1249
01:00:04,224 --> 01:00:10,830
PROGRAM BACK TO THE LAB TO 

1250
01:00:10,830 --> 01:00:13,133
ITERATIVELY IMPROVE THE VACCINE.

1251
01:00:13,133 --> 01:00:15,835
WE'RE ANTICIPATING FIVE TO SIX 

1252
01:00:15,835 --> 01:00:18,038
AWARDS FOR VACCINE DEVELOPMENT 

1253
01:00:18,038 --> 01:00:19,105
AND DEVELOPMENT CENTERS.

1254
01:00:19,105 --> 01:00:20,740
AIL TALK THROUGH BACKGROUND AND 

1255
01:00:20,740 --> 01:00:22,842
THE CURRENT PROGRAMS HERE OVER 

1256
01:00:22,842 --> 01:00:25,111
THE NEXT MINUTE OR SO.

1257
01:00:25,111 --> 01:00:27,514
AS WE'RE SEEING MORE AND MORE 

1258
01:00:27,514 --> 01:00:32,052
CASES OF H5N1 IN HUMANS AND 

1259
01:00:32,052 --> 01:00:33,787
CASES IN ANIMALS, THERE'S A NED 

1260
01:00:33,787 --> 01:00:36,556
FOR BROADLY PROTECTIVE INFLUENZA

1261
01:00:36,556 --> 01:00:39,426
VACCINE TO HELP US BE BETTER 

1262
01:00:39,426 --> 01:00:41,061
PREPARED FOR FUTURE PANDEMICS.

1263
01:00:41,061 --> 01:00:43,496
INFLUENZA STILL CAUTIONS 

1264
01:00:43,496 --> 01:00:44,064
SIGNIFICANT MORBIDITY AND 

1265
01:00:44,064 --> 01:00:46,833
MORTALITY AND WHILE WE HAD A 

1266
01:00:46,833 --> 01:00:49,602
LITTLE REPRIEVE DURING THE COVID

1267
01:00:49,602 --> 01:00:50,637
PANDEMIC IT'S ROARED BACK TO 

1268
01:00:50,637 --> 01:00:55,742
PRE-PANDEMIC LEVELS.

1269
01:00:55,742 --> 01:01:00,280
ABOUT 18 TO 35 MILLION ILLNESSES

1270
01:01:00,280 --> 01:01:03,683
AND 16 MILLION MEDICAL VISITS 

1271
01:01:03,683 --> 01:01:07,487
AND UP TO 440,000 HOSPITALIZINGS

1272
01:01:07,487 --> 01:01:14,094
AND UP TO 38,000 DEATHS.

1273
01:01:14,094 --> 01:01:18,765
WE HAVE VACCINATIONS AVAILABLE 

1274
01:01:18,765 --> 01:01:25,538
BUT IT UP TAKE FLUCTUATES.

1275
01:01:25,538 --> 01:01:31,111
BACK IN 2018 NIAID OUTLINED THE 

1276
01:01:31,111 --> 01:01:32,879
UNIVERSAL INFLUENZA VACCINE 

1277
01:01:32,879 --> 01:01:36,783
STRATEGY HOPING TO DEVELOP A 

1278
01:01:36,783 --> 01:01:38,051
UNIVERSAL FLU VACCINE 75% 

1279
01:01:38,051 --> 01:01:40,820
EFFECTIVE IN PROTECTING ILLNESS 

1280
01:01:40,820 --> 01:01:42,755
AND PROTECTING AGAINST GROUP 1 

1281
01:01:42,755 --> 01:01:45,291
AND 2 AND DURABLE PROTECTION 

1282
01:01:45,291 --> 01:01:47,994
THAT LASTS AT LEAST A YEAR AND 

1283
01:01:47,994 --> 01:01:50,029
SUITABLE FOR ALL AGENTS AND 

1284
01:01:50,029 --> 01:01:51,464
PATIENT TYPES.

1285
01:01:51,464 --> 01:01:54,234
MANY GROUPS AROUND THE WORLD USE

1286
01:01:54,234 --> 01:01:55,468
SLIGHTLY DIFFERENT ROLES IN 

1287
01:01:55,468 --> 01:01:56,169
ACHIEVING THIS.

1288
01:01:56,169 --> 01:01:58,505
OUR GOAL AT NIAID IS TO STRIVE 

1289
01:01:58,505 --> 01:02:00,807
FOR THE UNIVERSAL VACCINE THAT 

1290
01:02:00,807 --> 01:02:04,844
PROTECTS BROADLY BUT ALSO MAKE 

1291
01:02:04,844 --> 01:02:07,013
ADVANCES AGAINST STRAINS, 

1292
01:02:07,013 --> 01:02:13,119
MULTIPLE SUB TYPES AND GROUP 

1293
01:02:13,119 --> 01:02:13,353
VIRUSES.

1294
01:02:13,353 --> 01:02:23,730
TO THIS ENT A SINGLE 

1295
01:02:24,998 --> 01:02:26,900
MANUFACTURING SITE AT DUKE, TWO 

1296
01:02:26,900 --> 01:02:28,468
CLINICAL CORES AT DUKE AND THE 

1297
01:02:28,468 --> 01:02:30,069
UNIVERSITY OF MARYLAND AND A 

1298
01:02:30,069 --> 01:02:32,505
STATISTICAL DATA AND MANAGEMENT 

1299
01:02:32,505 --> 01:02:36,743
AND COORDINATION CENTER 

1300
01:02:36,743 --> 01:02:38,912
PRIMARILY RUN THROUGH DIGITAL 

1301
01:02:38,912 --> 01:02:45,118
INFUSION BY DELOITTE AND MM SC.

1302
01:02:45,118 --> 01:02:47,887
THIS REPRESENTS A COLLABORATIVE 

1303
01:02:47,887 --> 01:02:54,060
PROGRAM THROUGH DATE AND THE 

1304
01:02:54,060 --> 01:03:02,535
DMID PROGRAMS.

1305
01:03:02,535 --> 01:03:06,639
WE'VE HAD STAGES OF PRECLINICAL 

1306
01:03:06,639 --> 01:03:07,840
TESTING LEADING TO 13 PACKAGES 

1307
01:03:07,840 --> 01:03:10,843
SUBMITTED FOR MANUFACTURING.

1308
01:03:10,843 --> 01:03:14,380
WE'VE MADE SIGNIFICANT PROGRESS 

1309
01:03:14,380 --> 01:03:18,184
IN MOVING PRODUCTS THROUGH THE 

1310
01:03:18,184 --> 01:03:20,653
CASCADE FROM DISCOVERY TO 

1311
01:03:20,653 --> 01:03:22,522
PRE-TMP WORK AND PROCESS 

1312
01:03:22,522 --> 01:03:24,290
DEVELOPMENT INTO GMP 

1313
01:03:24,290 --> 01:03:26,025
MANUFACTURING AND JUST STARTING 

1314
01:03:26,025 --> 01:03:31,898
TO TRANSITION INTO SOME OF THOSE

1315
01:03:31,898 --> 01:03:34,334
PROGRAMS INTO PHASE 1 TESTING.

1316
01:03:34,334 --> 01:03:37,136
WE'VE BEEN SUCCESSFUL AS WELL 

1317
01:03:37,136 --> 01:03:40,306
MOVING TO CHALLENGE VIRUSES FOR 

1318
01:03:40,306 --> 01:03:45,445
HUMAN CHALLENGE STUDIES FOR THE 

1319
01:03:45,445 --> 01:03:47,880
H3N2 AND IS WIDELY AVAILABLE TO 

1320
01:03:47,880 --> 01:03:52,852
THE RESEARCH COMMUNITY.

1321
01:03:52,852 --> 01:03:54,887
OUR H1N1 HUMAN VIRUS IS STILL 

1322
01:03:54,887 --> 01:03:56,723
COMPLETING AND HOPEFULLY WILL 

1323
01:03:56,723 --> 01:03:58,925
MOVE INTO CLINICAL TESTING TO 

1324
01:03:58,925 --> 01:04:01,728
VALIDATE ITS UTILITY.

1325
01:04:01,728 --> 01:04:04,330
WE'VE MOVED ONE EXTERNAL 

1326
01:04:04,330 --> 01:04:06,232
CANDIDATE FORWARD FOR PEDIATRIC 

1327
01:04:06,232 --> 01:04:07,567
STUDIES AND THOSE RESULTS ARE 

1328
01:04:07,567 --> 01:04:10,870
STILL PENDING.

1329
01:04:10,870 --> 01:04:12,839
IT'S IMPORTANT TO NOTE WE MOVED 

1330
01:04:12,839 --> 01:04:16,276
A NUMBER OF NOVEL PRODUCTS WITH 

1331
01:04:16,276 --> 01:04:21,447
MECHANISMS OF ACTION AND 

1332
01:04:21,447 --> 01:04:27,220
BACKBONES AND LEVERAGES THE USE 

1333
01:04:27,220 --> 01:04:30,123
OF CANDIDATE ADJUVANTS.

1334
01:04:30,123 --> 01:04:31,758
CLINICALLY WE'VE ACCOMPLISHED A 

1335
01:04:31,758 --> 01:04:31,924
LOT.

1336
01:04:31,924 --> 01:04:33,660
WE HAVE SIX SITES CLINICALLY 

1337
01:04:33,660 --> 01:04:36,396
ACTIVE THAT HAVE TO DATE 

1338
01:04:36,396 --> 01:04:38,631
ENROLLED 550 INDIVIDUALS ACROSS 

1339
01:04:38,631 --> 01:04:39,198
FIVE CLINICAL STUDIES SHOWN 

1340
01:04:39,198 --> 01:04:49,309
HERE.

1341
01:04:56,282 --> 01:04:57,450
AND A CHALLENGE VIRUS IS NOW 

1342
01:04:57,450 --> 01:04:58,117
AVAILABLE TO THE RESEARCH 

1343
01:04:58,117 --> 01:04:59,585
COMMUNITY AND HOPEFULLY WILL 

1344
01:04:59,585 --> 01:05:04,891
HAVE SOMETHING SIMILAR FOR H1N1 

1345
01:05:04,891 --> 01:05:06,426
IN THE FUTURE.

1346
01:05:06,426 --> 01:05:07,827
ONE SIGNIFICANT DELIVERABLE FROM

1347
01:05:07,827 --> 01:05:09,629
THIS PROGRAM IS THE DEVELOPMENT 

1348
01:05:09,629 --> 01:05:11,964
OF A LARGE AMOUNT OF DATA BOTH 

1349
01:05:11,964 --> 01:05:16,436
FROM PRECLINICAL TO CLINICAL 

1350
01:05:16,436 --> 01:05:20,440
TRIALS THAT ARE AVAILABLE TO THE

1351
01:05:20,440 --> 01:05:22,075
RESEARCH COMMUNITY.

1352
01:05:22,075 --> 01:05:24,877
DESPITE ALL OF THESE ADVANTAGES,

1353
01:05:24,877 --> 01:05:27,547
THE PROGRAM HAS HAD A NUMBER OF 

1354
01:05:27,547 --> 01:05:27,847
CHALLENGES.

1355
01:05:27,847 --> 01:05:30,616
IT WAS A NEW TRANS DIVISIONAL 

1356
01:05:30,616 --> 01:05:31,684
COLLABORATIVE PROGRAM WITH A 

1357
01:05:31,684 --> 01:05:33,653
BROAD SCOPE OF RESEARCH 

1358
01:05:33,653 --> 01:05:33,920
ACTIVITY.

1359
01:05:33,920 --> 01:05:36,556
SO IT TOOK LEARNING TO FIGURE 

1360
01:05:36,556 --> 01:05:40,893
OUT HOW TO WORK EFFECTIVELY WITH

1361
01:05:40,893 --> 01:05:42,395
ONE ANOTHER AND MOVE TOGETHER IN

1362
01:05:42,395 --> 01:05:45,164
HARMONY AND WERE IMPACTED BY THE

1363
01:05:45,164 --> 01:05:47,734
SARS COV2 PANDEMIC DIRECTLY AND 

1364
01:05:47,734 --> 01:05:48,501
INDIRECTLY THE CLEAR DIRECT 

1365
01:05:48,501 --> 01:05:50,603
IMPACT IS ALL THE VACCINES WERE 

1366
01:05:50,603 --> 01:05:55,975
ASKED TO TRANSITION AND FOCUS ON

1367
01:05:55,975 --> 01:05:56,642
SARS COV2 AND WE'LL CONTINUE TO 

1368
01:05:56,642 --> 01:05:59,312
DO WORK ON THE PROGRAM.

1369
01:05:59,312 --> 01:06:01,114
ADDITIONALLY THERE WERE INDIRECT

1370
01:06:01,114 --> 01:06:04,550
THINGS LIKE DIFFICULTY FINDING 

1371
01:06:04,550 --> 01:06:05,885
REAGENTS, ABILITY TO FIND THINGS

1372
01:06:05,885 --> 01:06:08,187
LIKE VIALS TO PRODUCE THE 

1373
01:06:08,187 --> 01:06:10,056
VACCINES AND EVEN NOW STILL 

1374
01:06:10,056 --> 01:06:11,357
CAUSING CHALLENGES WITH OUR 

1375
01:06:11,357 --> 01:06:18,097
ABILITY TO PRODUCE VACCINES.

1376
01:06:18,097 --> 01:06:19,899
THE OTHER CHALLENGE IS WE 

1377
01:06:19,899 --> 01:06:22,635
LEARNED A LOT ABOUT VACCINE 

1378
01:06:22,635 --> 01:06:22,935
DEVELOPMENT.

1379
01:06:22,935 --> 01:06:26,672
WE HAD CHALLENGES IN THE PRODUCT

1380
01:06:26,672 --> 01:06:28,808
DEVELOPMENT AND STAGE OF THE 

1381
01:06:28,808 --> 01:06:30,843
CENTERS THAT WERE DISCOVERING 

1382
01:06:30,843 --> 01:06:32,111
THE VACCINES THAT WERE HANDED 

1383
01:06:32,111 --> 01:06:34,881
AFTER TO DUKE OR OTHER PARTNERS 

1384
01:06:34,881 --> 01:06:36,849
TO REALLY MOVE THE PRODUCT INTO 

1385
01:06:36,849 --> 01:06:37,183
MANUFACTURING.

1386
01:06:37,183 --> 01:06:39,185
WHAT WE'VE LEARNED IS THIS NEEDS

1387
01:06:39,185 --> 01:06:44,690
TO BE AN ITERATIVE PROCESS WITH 

1388
01:06:44,690 --> 01:06:46,492
EXPERT INPUT AND CLOSE 

1389
01:06:46,492 --> 01:06:47,126
COLLABORATION WITH THE VACCINE 

1390
01:06:47,126 --> 01:06:47,827
AND MANUFACTURING CENTER.

1391
01:06:47,827 --> 01:06:50,296
WE HAD SOME PRODUCTS THAT GOT 

1392
01:06:50,296 --> 01:06:51,397
HUNG UP AT THAT STAGE.

1393
01:06:51,397 --> 01:06:53,132
WHEN WE WENT BACK AND TOLD THE 

1394
01:06:53,132 --> 01:06:58,738
CENTER GO FIND A PARTNER TO WORK

1395
01:06:58,738 --> 01:07:01,107
WITH COLLABORATIVELY WE WERE 

1396
01:07:01,107 --> 01:07:01,941
ABLE TO ACCELERATE THE PROGRAM.

1397
01:07:01,941 --> 01:07:03,609
WITH THIS RENEWAL WE HOPE TO 

1398
01:07:03,609 --> 01:07:06,512
ADDRESS SOME OF THESE KEY 

1399
01:07:06,512 --> 01:07:07,847
CHALLENGES BUT ALSO SIMPLIFYING 

1400
01:07:07,847 --> 01:07:10,583
AND STREAMLINING THE PROGRAM 

1401
01:07:10,583 --> 01:07:13,019
WHILE REMAINING ON FOCUS TO THE 

1402
01:07:13,019 --> 01:07:14,587
PRODUCT DEVELOPMENT PLATFORM.

1403
01:07:14,587 --> 01:07:16,889
SO WE WANT THE GREAT SCIENCE TO 

1404
01:07:16,889 --> 01:07:19,058
BE SUPPORTED BY THIS IN THE END 

1405
01:07:19,058 --> 01:07:21,060
WE WANT VACCINE CANDIDATES THAT 

1406
01:07:21,060 --> 01:07:25,097
MOVED THROUGH MANUFACTURING INTO

1407
01:07:25,097 --> 01:07:27,700
THE CLINICAL SETTING TO LEARN 

1408
01:07:27,700 --> 01:07:28,868
AND IMPROVE ON VACCINES.

1409
01:07:28,868 --> 01:07:31,904
TO THIS END WE PROPOSED A 

1410
01:07:31,904 --> 01:07:34,874
SIMPLIFIED PROGRAM OF THE CIVICS

1411
01:07:34,874 --> 01:07:35,541
PROGRAM.

1412
01:07:35,541 --> 01:07:36,809
.

1413
01:07:36,809 --> 01:07:40,880
IT WILL CONTINUE TO HAVE NIAID 

1414
01:07:40,880 --> 01:07:45,451
CIVICS OVERSIGHT TEAM FOR A 

1415
01:07:45,451 --> 01:07:46,085
COLLABORATIVE EFFORT BETWEEN 

1416
01:07:46,085 --> 01:07:47,620
DATE AND DMID.

1417
01:07:47,620 --> 01:07:51,023
DATE WILL BE SUPPORTING AND 

1418
01:07:51,023 --> 01:07:52,925
PRESENTING THE CONCEPT FOR THE 

1419
01:07:52,925 --> 01:07:54,827
DATA MANAGEMENT AND COORDINATION

1420
01:07:54,827 --> 01:07:56,629
CENTER ALSO FUNDING THE EXTERNAL

1421
01:07:56,629 --> 01:07:58,898
ADVISORY GROUP.

1422
01:07:58,898 --> 01:08:03,402
THIS WILL BE AN EXTERNAL GROUP 

1423
01:08:03,402 --> 01:08:06,706
OF EXPERTS TO ADVISE US ABOUT 

1424
01:08:06,706 --> 01:08:09,976
THE VACCINE DEVELOPMENT.

1425
01:08:09,976 --> 01:08:15,381
THE CORNERSTONE OF THIS PROJECT 

1426
01:08:15,381 --> 01:08:20,219
THAT WE'RE TALKING WE'RE 

1427
01:08:20,219 --> 01:08:21,053
INCREASING THE NUMBERS FROM 

1428
01:08:21,053 --> 01:08:22,421
THREE TO FIVE TO SIX WITH THE 

1429
01:08:22,421 --> 01:08:25,091
GOAL OF HOPING TO HAVE MORE 

1430
01:08:25,091 --> 01:08:26,692
GROUPS WORKING VERY CAREFULLY TO

1431
01:08:26,692 --> 01:08:30,463
MOVE PROJECTS FORWARD.

1432
01:08:30,463 --> 01:08:33,132
THE OTHER THING THAT'S GOING TO 

1433
01:08:33,132 --> 01:08:34,734
CHANGE IS THE DUTY OF THE 

1434
01:08:34,734 --> 01:08:35,401
VACCINE DEVELOPMENT CENTER TO 

1435
01:08:35,401 --> 01:08:40,940
TAKE A CANDIDATE AND MOVE IT 

1436
01:08:40,940 --> 01:08:45,912
THROUGH PROCESS INTO THE CLINIC.

1437
01:08:45,912 --> 01:08:49,315
THEY'LL HAVE TO PARTNER WITH 

1438
01:08:49,315 --> 01:08:51,150
ORGANIZATIONS TO MOVE THIS 

1439
01:08:51,150 --> 01:08:52,652
FORWARD.

1440
01:08:52,652 --> 01:08:57,123
WE'LL NOT BE FUNDING A SEPARATE 

1441
01:08:57,123 --> 01:08:57,590
CORE.

1442
01:08:57,590 --> 01:08:58,891
WE'RE ALSO REQUESTING THE 

1443
01:08:58,891 --> 01:09:01,427
CENTERS WHEN THEY COME INTO THE 

1444
01:09:01,427 --> 01:09:06,032
GRANT THEY COME IN WITH WHAT'S 

1445
01:09:06,032 --> 01:09:07,233
CALLED TECHNOLOGY READINESS 

1446
01:09:07,233 --> 01:09:09,101
LEVEL 5 OR 6 CANDIDATE.

1447
01:09:09,101 --> 01:09:11,871
IT'S A CANDIDATE ARE THE WITHIN 

1448
01:09:11,871 --> 01:09:21,047
A YEAR TO MOVE INTO GM P 

1449
01:09:21,047 --> 01:09:21,380
MANUFACTURING.

1450
01:09:21,380 --> 01:09:31,857
SO THEY CAN MOVE FORWARD ON 

1451
01:09:35,361 --> 01:09:37,096
OTHER VACCINE CANDIDATES.

1452
01:09:37,096 --> 01:09:38,297
WE'LL HAVE MANUFACTURING AND 

1453
01:09:38,297 --> 01:09:42,868
PROCESS DEVELOPMENT AND TRIALS 

1454
01:09:42,868 --> 01:09:46,572
AS SEPARATE OPTIONS AS THE 

1455
01:09:46,572 --> 01:09:46,839
STRUCTURE.

1456
01:09:46,839 --> 01:09:49,175
EACH VACCINE DISCOVERY AND 

1457
01:09:49,175 --> 01:09:51,644
DEVELOPMENT CENTER WILL NEED AN 

1458
01:09:51,644 --> 01:09:55,848
ASSAY CORE RESPONSIBLE FOR 

1459
01:09:55,848 --> 01:09:57,116
ASSAYS NOT PERFORMED BY THE 

1460
01:09:57,116 --> 01:09:59,185
VACCINE TESTING SERVICES AND 

1461
01:09:59,185 --> 01:10:01,120
THESE ARE THINGS THAT ARE 

1462
01:10:01,120 --> 01:10:01,988
SPECIFIC TO THE INDIVIDUAL 

1463
01:10:01,988 --> 01:10:04,290
VACCINE THEY ARE DEVELOPING.

1464
01:10:04,290 --> 01:10:06,459
THERE MAY BE SPECIFIC T AND B 

1465
01:10:06,459 --> 01:10:09,128
CELL OR ANTIBODY RESPONSES 

1466
01:10:09,128 --> 01:10:13,099
UNIQUE TO THEIR VACCINES NOT 

1467
01:10:13,099 --> 01:10:15,568
PART OF TESTING ACROSS ALL 

1468
01:10:15,568 --> 01:10:17,069
VACCINE CANDIDATE.

1469
01:10:17,069 --> 01:10:20,106
THOSE CONSISTENT TESTS WILL BE 

1470
01:10:20,106 --> 01:10:26,712
PERFORMED BY THE VACCINE TESTING

1471
01:10:26,712 --> 01:10:28,948
SERVICES INCLUDING THE HA STOCK 

1472
01:10:28,948 --> 01:10:31,651
AND INHIBITION ASSAYS.

1473
01:10:31,651 --> 01:10:35,755
IN ADDITION, THE VACCINE CENTERS

1474
01:10:35,755 --> 01:10:39,659
WILL BE ABLE TO WITH 

1475
01:10:39,659 --> 01:10:41,127
CONSULTATION OF THE OVERSIGHT 

1476
01:10:41,127 --> 01:10:44,664
TEAM TO USE GAP-FILLING TOOLS 

1477
01:10:44,664 --> 01:10:47,466
THROUGHOUT THE NIAID SUPPORT 

1478
01:10:47,466 --> 01:10:49,135
PROGRAM INCLUDING THINGS THROUGH

1479
01:10:49,135 --> 01:10:54,507
ADJUVANTS AND ANIMAL MODELS AND 

1480
01:10:54,507 --> 01:10:54,874
STUDIES PLACED.

1481
01:10:54,874 --> 01:10:59,612
THEY'LL BE ABLE TO WORK WITH 

1482
01:10:59,612 --> 01:11:01,113
VACCINE MANUFACTURING SERVICE TO

1483
01:11:01,113 --> 01:11:04,450
DEVELOP MASTER CELL BANKS AND 

1484
01:11:04,450 --> 01:11:07,653
VIRUSES POTENTIALLY AND GMP 

1485
01:11:07,653 --> 01:11:09,055
SUPPORT IF THEY AREN'T ABLE TO 

1486
01:11:09,055 --> 01:11:12,425
FIND OTHER MECHANISMS TO MOVE 

1487
01:11:12,425 --> 01:11:12,692
FORWARDS.

1488
01:11:12,692 --> 01:11:15,995
ANOTHER KEY CHANGE FOR THE 

1489
01:11:15,995 --> 01:11:20,566
RENEWAL IS WE'LL BE LEVERAGING 

1490
01:11:20,566 --> 01:11:22,935
THE NIAID INFRASTRUCTURE YOU'LL 

1491
01:11:22,935 --> 01:11:24,537
HEAR ABOUT NEXT TO COMPLETE OUR 

1492
01:11:24,537 --> 01:11:28,908
PHASE 2 AND TWO STUDIES.

1493
01:11:28,908 --> 01:11:31,343
IF WE DO CHALLENGE STUDIES IT 

1494
01:11:31,343 --> 01:11:32,978
WILL STREAMLINE STORAGE AND 

1495
01:11:32,978 --> 01:11:33,612
STATISTICAL MANAGEMENT OF THESE 

1496
01:11:33,612 --> 01:11:38,084
STUDIES.

1497
01:11:38,084 --> 01:11:43,723
I HAD A  WONDERFUL TIME CHATTING

1498
01:11:43,723 --> 01:11:45,891
WITH DR. ESTES AND PALMER AND 

1499
01:11:45,891 --> 01:11:49,128
THEY CLARIFIED A FEW THINGS 

1500
01:11:49,128 --> 01:11:52,932
HOPEFULLY I DID DURING THE 

1501
01:11:52,932 --> 01:12:01,207
PRESENTATION AND TALK ABOUT WHAT

1502
01:12:01,207 --> 01:12:08,047
A TRL IS AND TAKING MORE 

1503
01:12:08,047 --> 01:12:09,115
CONCEPTS FORWARD AND MOVE THINS

1504
01:12:09,115 --> 01:12:10,916
INTO PRODUCT DEVELOPMENT.

1505
01:12:10,916 --> 01:12:12,685
WITH THAT, THAT'S OUR RENEWAL.

1506
01:12:12,685 --> 01:12:13,385
HAPPY TO ANSWER ANY QUESTIONS 

1507
01:12:13,385 --> 01:12:23,629
YOU MAY HAVE.

1508
01:12:25,998 --> 01:12:28,934
ANY QUESTIONS OR COMMENTS OR 

1509
01:12:28,934 --> 01:12:39,211
COLLABORATIONS.

1510
01:12:39,979 --> 01:12:40,379
THANKS, MIKE.

1511
01:12:40,379 --> 01:12:42,848
OUR LAST DMID CONCEPT, SECOND TO

1512
01:12:42,848 --> 01:12:44,950
LAST OVER ALL IS GOING TO BE 

1513
01:12:44,950 --> 01:12:46,719
PRESENTED BY ANDREW BURNHAM OF 

1514
01:12:46,719 --> 01:12:55,795
THE OFFICE OF CLINICAL RESEARCH 

1515
01:12:55,795 --> 01:12:56,328
RESOU

1516
01:12:56,328 --> 01:12:56,862
RESOURCES.

1517
01:12:56,862 --> 01:12:57,496
>> THANK YOU.

1518
01:12:57,496 --> 01:12:58,964
I'M A PROGRAM OFFICER IN THING 

1519
01:12:58,964 --> 01:13:03,235
OFF OF CLINICAL RESEARCH 

1520
01:13:03,235 --> 01:13:04,937
RESOURCES.

1521
01:13:04,937 --> 01:13:12,411
THIS IS CALLED THE CLINICAL 

1522
01:13:12,411 --> 01:13:14,513
RESEARCH OPERATIONS CORE WITH 

1523
01:13:14,513 --> 01:13:15,347
ACTIVITIES THAT ADDRESS 

1524
01:13:15,347 --> 01:13:15,948
SCIENTIFIC PRIORITIES.

1525
01:13:15,948 --> 01:13:17,583
THE IS A NEW INITIATIVE AND 

1526
01:13:17,583 --> 01:13:22,755
WE'LL BE USING A CONTRACT 

1527
01:13:22,755 --> 01:13:23,556
MECHANISM.

1528
01:13:23,556 --> 01:13:24,723
WE ANTICIPATE MAKING ONE.

1529
01:13:24,723 --> 01:13:26,792
OF WAY AS BACKGROUND AS YOU SAW 

1530
01:13:26,792 --> 01:13:28,093
THROUGH MANY PRESENTATIONS WE 

1531
01:13:28,093 --> 01:13:29,695
SUPPORT THE BROAD RANGE OF 

1532
01:13:29,695 --> 01:13:31,397
CLINICAL RESEARCH.

1533
01:13:31,397 --> 01:13:33,566
THIS INCLUDES PHASE 0-4 CLINICAL

1534
01:13:33,566 --> 01:13:37,102
TRIALS IN THERAPEUTICS AND 

1535
01:13:37,102 --> 01:13:39,004
VACCINES.

1536
01:13:39,004 --> 01:13:44,944
COHORT STUDIES AND EVALUATION OF

1537
01:13:44,944 --> 01:13:49,114
NEW DIAGNOSTICS AND LOOK AT 

1538
01:13:49,114 --> 01:13:51,317
POTENTIAL AGENTS OF BIO 

1539
01:13:51,317 --> 01:13:53,085
TERRORISM AND NIAID PRIORITY 

1540
01:13:53,085 --> 01:13:58,390
PATHOGENS.

1541
01:13:58,390 --> 01:14:00,693
WITH THE INFRASTRUCTURE IT'S 

1542
01:14:00,693 --> 01:14:03,696
PLAY A ROLE IN THE DMID 

1543
01:14:03,696 --> 01:14:05,598
SCIENTIFIC PRIVATES.

1544
01:14:05,598 --> 01:14:07,366
LESSONS LEARNED FROM RECENT 

1545
01:14:07,366 --> 01:14:08,968
CLINICAL TRIALS AND OUTBREAKS 

1546
01:14:08,968 --> 01:14:11,337
DEMONSTRATED FUNDING OF 

1547
01:14:11,337 --> 01:14:13,572
OPERATIONS IN SITES AND RAPIDLY 

1548
01:14:13,572 --> 01:14:16,942
RESPOND DURING PUBLIC HEALTH 

1549
01:14:16,942 --> 01:14:17,243
EMERGENCIES.

1550
01:14:17,243 --> 01:14:19,812
FOR EXAMPLE, THEY CONDUCTED 

1551
01:14:19,812 --> 01:14:21,280
MULTIPLE PHASE III TRIALS AS 

1552
01:14:21,280 --> 01:14:22,848
PART OF OUR COVID-19 RESPONSE.

1553
01:14:22,848 --> 01:14:24,383
THE SPEED AT WHICH THE TRIALS 

1554
01:14:24,383 --> 01:14:27,052
CAME ONLINE AND LATER EVOLVED 

1555
01:14:27,052 --> 01:14:32,558
OUTPACED THE ABILITY OF OUR 

1556
01:14:32,558 --> 01:14:32,791
SYSTEMS.

1557
01:14:32,791 --> 01:14:36,829
SO THE CLINICAL RESEARCH 

1558
01:14:36,829 --> 01:14:38,030
OPERATIONS CORE WILL PROVIDER A 

1559
01:14:38,030 --> 01:14:39,565
RESEARCH FOR CLINICAL TRIALS AND

1560
01:14:39,565 --> 01:14:41,166
RESEARCH ACROSS DMID'S 

1561
01:14:41,166 --> 01:14:44,436
SCIENTIFIC PRIORITIES.

1562
01:14:44,436 --> 01:14:47,740
THE CORE WILL PROMOTE EFFICIENT 

1563
01:14:47,740 --> 01:14:49,675
COORDINATION OF OPERATIONS 

1564
01:14:49,675 --> 01:14:51,610
ACROSS AREAS.

1565
01:14:51,610 --> 01:14:53,245
SPECIFICALLY, THE OPS CORE WILL 

1566
01:14:53,245 --> 01:14:55,047
OVERSEE AND MANAGE THE FOLLOWING

1567
01:14:55,047 --> 01:14:57,917
ACTIVITIES, PROTOCOL DEVELOPMENT

1568
01:14:57,917 --> 01:14:59,718
WHERE IT WILL OVERSEE AND 

1569
01:14:59,718 --> 01:15:04,556
DEVELOP PROTOCOLS, NFK INFORMED 

1570
01:15:04,556 --> 01:15:05,758
CONSENT FORMS AND SITE SELECTION

1571
01:15:05,758 --> 01:15:09,695
TO IDENTIFY SITES FROM ACROSS 

1572
01:15:09,695 --> 01:15:10,462
NIAID'S INFRASTRUCTURE THAT BEST

1573
01:15:10,462 --> 01:15:14,199
MEET THE NEEDS OF THE STUDY.

1574
01:15:14,199 --> 01:15:18,103
STUDY MANAGEMENT WHERE LL -- IT 

1575
01:15:18,103 --> 01:15:19,171
WILL OVERSEE AND START UP AND 

1576
01:15:19,171 --> 01:15:22,408
CLOSE OUT ACTIVITIES AND 

1577
01:15:22,408 --> 01:15:22,975
COORDINATION WHERE IT WILL 

1578
01:15:22,975 --> 01:15:23,509
COORDINATE WITH VARIOUS 

1579
01:15:23,509 --> 01:15:25,311
STAKEHOLDERS TO ENSURE TIMELY 

1580
01:15:25,311 --> 01:15:26,812
DISSEMINATION OF RESULTS.

1581
01:15:26,812 --> 01:15:29,782
THIS IS WHERE WE SEE THESE 

1582
01:15:29,782 --> 01:15:31,817
ACTIVITIES TO BE ADDITIVE OR AS 

1583
01:15:31,817 --> 01:15:34,086
NEW NOOEDZ COME YONL LINE 

1584
01:15:34,086 --> 01:15:34,887
THEY'RE ABLE TO BE MET WITH NEW 

1585
01:15:34,887 --> 01:15:36,455
RESOURCES WHILE WE ARE ABLE TO 

1586
01:15:36,455 --> 01:15:38,691
CONTINUE WITH THE CURRENT 

1587
01:15:38,691 --> 01:15:38,991
ACTIVITIES.

1588
01:15:38,991 --> 01:15:40,926
WE ALSO ANTICIPATE SOME OF THESE

1589
01:15:40,926 --> 01:15:44,029
ACTIVITIES COULD BE CONDUCTED IN

1590
01:15:44,029 --> 01:15:46,532
PARALLEL DURING A PANDEMIC 

1591
01:15:46,532 --> 01:15:47,299
RESPONSE OR RAPID RESPONSE TYPE 

1592
01:15:47,299 --> 01:15:54,406
SITUATION.

1593
01:15:54,406 --> 01:15:57,343
THE OPS CORE WILL OPERATIONALIZE

1594
01:15:57,343 --> 01:15:58,677
CLINICAL TRIALS DEVELOPED BY 

1595
01:15:58,677 --> 01:15:59,378
SCIENTIFIC NETWORKS AND IN 

1596
01:15:59,378 --> 01:16:02,014
RESPONSE TO EMERGING AND 

1597
01:16:02,014 --> 01:16:03,248
RE-EMERGING DISEASE OUTBREAKS.

1598
01:16:03,248 --> 01:16:08,821
AS DR. ISON MENTIONED THE OPS 

1599
01:16:08,821 --> 01:16:10,255
CORE WILL RUN THE CLINICAL 

1600
01:16:10,255 --> 01:16:11,457
TRIALS DEVELOPED BY THE CIVICS 

1601
01:16:11,457 --> 01:16:11,890
PROGRAM.

1602
01:16:11,890 --> 01:16:17,363
THE YEAR ONE ACTIVITIES WILL 

1603
01:16:17,363 --> 01:16:18,263
FOCUS ON INFLUENZA VACCINE 

1604
01:16:18,263 --> 01:16:20,065
TRIALS WITH LATER EXPANSION TO 

1605
01:16:20,065 --> 01:16:20,366
PRIORITIES.

1606
01:16:20,366 --> 01:16:25,104
SO FOR COUNCIL FEEDBACK I WAS 

1607
01:16:25,104 --> 01:16:33,112
ABLE TO MEET WITH DOCTORS TAYOR 

1608
01:16:33,112 --> 01:16:39,585
AND BOCKENSTEDT AND INDICATED 

1609
01:16:39,585 --> 01:16:39,818
SUPPORT.

1610
01:16:39,818 --> 01:16:41,887
THE COMMENTS AND FEEDBACK WERE 

1611
01:16:41,887 --> 01:16:44,189
TO EMPHASIZE HOW THE OPS CORE 

1612
01:16:44,189 --> 01:16:44,890
COULD RESPONSE IN THE FUTURE 

1613
01:16:44,890 --> 01:16:51,397
BASED ON THE LESSONS LEARNED.

1614
01:16:51,397 --> 01:16:59,571
AND BE HAPPY TO TAKE QUESTIONS.

1615
01:16:59,571 --> 01:17:01,740
>> HOW IS THIS DIFFERENT
FROM 

1616
01:17:01,740 --> 01:17:04,977
THE BTUs.

1617
01:17:04,977 --> 01:17:08,647
>> THIS IS A FUTURE
INITIATIVE 

1618
01:17:08,647 --> 01:17:09,948
TO OPERATIONALIZE THE TRIALS 

1619
01:17:09,948 --> 01:17:20,292
ACROSS THE NETWORKS.

1620
01:17:22,895 --> 01:17:27,232
>> WE HAVE LEADERSHIP
GROUPS IN 

1621
01:17:27,232 --> 01:17:29,134
CONTROL OF GRANTS WHICH END UP 

1622
01:17:29,134 --> 01:17:34,673
BEING A LESS MECHANISM FOR 

1623
01:17:34,673 --> 01:17:40,479
FLOWING PROTOCOL FUNDS IN A 

1624
01:17:40,479 --> 01:17:41,046
PUBLIC HEALTH EMERGENCY.

1625
01:17:41,046 --> 01:17:45,117
THERE ARE SPECIFIC CHALLENGES 

1626
01:17:45,117 --> 01:17:49,822
CREATED DURING COVID.

1627
01:17:49,822 --> 01:17:52,124
>> THE VTUs ARE A LONG
STANDING 

1628
01:17:52,124 --> 01:17:53,759
PROGRAM FOR NIAID AND LEVERAGED 

1629
01:17:53,759 --> 01:17:55,761
THEM AS BEST WE COULD.

1630
01:17:55,761 --> 01:17:57,362
WE'RE LOOKING -- WHAT WE LEARNED

1631
01:17:57,362 --> 01:18:00,299
IN THE PANDEMIC WAS A BIGGER 

1632
01:18:00,299 --> 01:18:04,336
SCOPE OF TRIALS, MULTICENTER 

1633
01:18:04,336 --> 01:18:06,505
SOMETIMES 50, 60, 70 CENTERS FOR

1634
01:18:06,505 --> 01:18:08,474
TRIALS AND BEING ABLE TO RESPOND

1635
01:18:08,474 --> 01:18:12,678
TO A PANDEMIC IN THAT SITUATION 

1636
01:18:12,678 --> 01:18:14,213
WE LOOKED FOR DIFFERENT 

1637
01:18:14,213 --> 01:18:19,818
MECHANISMS TO INCREASE OUR 

1638
01:18:19,818 --> 01:18:22,688
FLEXIBILITY AND SO THAT'S WHERE 

1639
01:18:22,688 --> 01:18:24,022
THE IDEAS WERE BORN FROM.

1640
01:18:24,022 --> 01:18:24,356
?

1641
01:18:24,356 --> 01:18:31,597
AND A NEW AWARD TO I AA  -- TO A

1642
01:18:31,597 --> 01:18:33,732
NEW SITE AND SCALING UP TO NEW 

1643
01:18:33,732 --> 01:18:35,067
OPERATIONS WHEN THAT WAS 

1644
01:18:35,067 --> 01:18:36,702
REQUIRED ARE THE SORTS OF THINGS

1645
01:18:36,702 --> 01:18:40,506
CONTRACTS OFTEN DO BETTER IN OR 

1646
01:18:40,506 --> 01:18:45,144
ALLOW US TO DO BETTER THAN IN A 

1647
01:18:45,144 --> 01:18:55,420
GRANT MECHANISM.

1648
01:18:58,056 --> 01:18:59,324
>> ANY OTHER COMMENTS OR 

1649
01:18:59,324 --> 01:19:03,896
QUESTIONS FOR ANDY?

1650
01:19:03,896 --> 01:19:05,063
>> THANK YOU.

1651
01:19:05,063 --> 01:19:09,134
>> THANK YOU SO, WE'RE
BEING 

1652
01:19:09,134 --> 01:19:11,770
VERY EFFICIENT.

1653
01:19:11,770 --> 01:19:13,639
THE NEXT CONCEPT FROM THE 

1654
01:19:13,639 --> 01:19:18,810
DIVISION OF CLINICAL RESEARCH 

1655
01:19:18,810 --> 01:19:28,921
AND I THINK I SAW DR. CONNIE 

1656
01:19:28,921 --> 01:19:30,355
SCHMALJOHN'S NAME.

1657
01:19:30,355 --> 01:19:33,125
>> I'M SHARING MY SLIDES.

1658
01:19:33,125 --> 01:19:38,463
CAN YOU SEE THEM?

1659
01:19:38,463 --> 01:19:43,235
>> YES.

1660
01:19:43,235 --> 01:19:44,870
GOOD AFTERNOON I'M THE DIRECTOR 

1661
01:19:44,870 --> 01:19:48,240
AT IRF-FREDERICK.

1662
01:19:48,240 --> 01:19:50,108
I'M PART OF THING OFF OF 

1663
01:19:50,108 --> 01:19:51,410
SCIENTIFIC AND ADMINISTRATIVE 

1664
01:19:51,410 --> 01:19:52,945
MANAGEMENT AND THANK YOU FOR 

1665
01:19:52,945 --> 01:19:55,080
ALLOWING ME TO INTRUDE ON THIS 

1666
01:19:55,080 --> 01:19:57,649
MEETING AND ALLOWING ME TO DO 

1667
01:19:57,649 --> 01:19:58,717
THIS VIRTUALLY SO I DON'T HAVE 

1668
01:19:58,717 --> 01:20:00,219
TO DRIVE THIS TIME OF DAY.

1669
01:20:00,219 --> 01:20:03,555
THE CONCEPT I AM PRESENTING IS 

1670
01:20:03,555 --> 01:20:06,658
THE RECOMPETE FOR RENEWAL OF THE

1671
01:20:06,658 --> 01:20:07,693
OPERATIONS AND MANAGEMENT FOR 

1672
01:20:07,693 --> 01:20:09,928
THE NIAID INTEGRATED RESEARCH 

1673
01:20:09,928 --> 01:20:13,131
FACILITY AT FORT DETRICK FOR THE

1674
01:20:13,131 --> 01:20:19,338
IRF FREDERICK.

1675
01:20:19,338 --> 01:20:21,139
IT'S A CONTINUATION OF 

1676
01:20:21,139 --> 01:20:21,707
SCIENTIFIC ADMINISTRATIVE 

1677
01:20:21,707 --> 01:20:29,081
OPERATIONS AT THE IRF FREDERICK 

1678
01:20:29,081 --> 01:20:32,050
TO FACILITATE THE PROGRAM AND 

1679
01:20:32,050 --> 01:20:33,151
THE MISSION AND PORTFOLIO.

1680
01:20:33,151 --> 01:20:36,521
THIS IS A RENEWAL OR RECOMPETE 

1681
01:20:36,521 --> 01:20:39,825
OF THE OPERATIONS CONTRACT.

1682
01:20:39,825 --> 01:20:41,760
IT'S THE NATIONAL RESOURCE AND S

1683
01:20:41,760 --> 01:20:43,962
OPPORTUNITIES FOR MAXIMUM 

1684
01:20:43,962 --> 01:20:44,630
CONTAINMENT RESEARCH TO 

1685
01:20:44,630 --> 01:20:46,198
GOVERNMENT, ACADEMIA AND 

1686
01:20:46,198 --> 01:20:48,634
INDUSTRY PARTNERS WHO COULD NOT 

1687
01:20:48,634 --> 01:20:53,672
OTHERWISE CONDUCT SUCH RESEARCH.

1688
01:20:53,672 --> 01:20:57,142
WE HAVE THE FACILITY CAPABLE OF 

1689
01:20:57,142 --> 01:20:59,077
ANIMAL MODELS OF DISEASE IN A 

1690
01:20:59,077 --> 01:21:02,481
SETTING AND THE PICTURES SHOW AN

1691
01:21:02,481 --> 01:21:04,783
ILLUSTRATION AND THERE'S A 

1692
01:21:04,783 --> 01:21:06,285
SCIENTIST IN THE LEVEL 4 LAB AND

1693
01:21:06,285 --> 01:21:08,120
THE ANIMAL IS ON THE CONVEYOR 

1694
01:21:08,120 --> 01:21:10,689
TABLE READY TO GO THROUGH THE 

1695
01:21:10,689 --> 01:21:17,095
PORT IN THE WALL WHICH MAINTAIN 

1696
01:21:17,095 --> 01:21:19,731
THE ENVIRONMENT THOUGH THE BSL 

1697
01:21:19,731 --> 01:21:22,567
PORTION OF THE BUILDING THE 

1698
01:21:22,567 --> 01:21:24,970
MACHINE MOVES OVER THE TUBE FOR 

1699
01:21:24,970 --> 01:21:27,606
THE IMAGING AND THE ANIMAL IS 

1700
01:21:27,606 --> 01:21:30,242
RETURNED TO THE BSL-4 PORTION OF

1701
01:21:30,242 --> 01:21:31,510
THE LABORATORY.

1702
01:21:31,510 --> 01:21:32,444
SOME CAPABILITIES INCLUDING 

1703
01:21:32,444 --> 01:21:42,988
IMAGING OF ALL SIZES OF ANIMAL, 

1704
01:21:43,655 --> 01:21:45,123
11,000 SQUARE FEET OF THE 

1705
01:21:45,123 --> 01:21:47,092
LABORATORY SPACE AND HOLDING 

1706
01:21:47,092 --> 01:21:55,000
ROOMS AND ANIMAL ROOMS AND THE 

1707
01:21:55,000 --> 01:21:59,071
NECROPSY SUITE AND SMALL 

1708
01:21:59,071 --> 01:22:01,139
PARTICLE AEROBIOLOGY AND 

1709
01:22:01,139 --> 01:22:04,409
SUPPORTING SPACING AND 

1710
01:22:04,409 --> 01:22:06,144
BORT-CERTIFIED PATHOLOGISTS AND 

1711
01:22:06,144 --> 01:22:10,082
A.I. EXPERTISE AND ORGAN-ON-CHIP

1712
01:22:10,082 --> 01:22:10,882
AND LABORATORY AND TRAINING FOR 

1713
01:22:10,882 --> 01:22:16,388
THE CLINICAL STUDIES IN RESOURCE

1714
01:22:16,388 --> 01:22:18,924
FOR POOR SETTINGS PRIMARILY IN 

1715
01:22:18,924 --> 01:22:19,191
AFRICA.

1716
01:22:19,191 --> 01:22:22,728
IT'S TO SERVE AS A RESPONSIVE 

1717
01:22:22,728 --> 01:22:25,497
AND COLLABORATIVE RESOURCE TO 

1718
01:22:25,497 --> 01:22:29,334
UNDERSTAND, TREAT AND ERADICATE 

1719
01:22:29,334 --> 01:22:31,636
DISEASES CAUSED BY NOVEL 

1720
01:22:31,636 --> 01:22:34,373
EMERGING AND VIRULENT PATHOGENS 

1721
01:22:34,373 --> 01:22:40,145
AND THIS IS HOW WE DEVELOP THE 

1722
01:22:40,145 --> 01:22:50,789
PORTFOLIO AND SELECT PROJECTS 

1723
01:22:52,224 --> 01:22:57,129
AND THE LAB LOCATED IN MONTANA 

1724
01:22:57,129 --> 01:23:02,200
AND UNLIKE RM11 FREDERICK DOES 

1725
01:23:02,200 --> 01:23:03,668
NOT DO P.I. RESEARCH BUT SORT 

1726
01:23:03,668 --> 01:23:05,070
THE WORK OF GOVERNMENT, INDUSTRY

1727
01:23:05,070 --> 01:23:08,740
AND ACADEMIC PARTNERS.

1728
01:23:08,740 --> 01:23:13,145
RESEARCH PROPOSALS WORK WITH 

1729
01:23:13,145 --> 01:23:15,914
PA

1730
01:23:15,914 --> 01:23:16,248
PA

1731
01:23:16,248 --> 01:23:19,718
PARTNERS HAVE THE FINAL REVIEW 

1732
01:23:19,718 --> 01:23:21,119
OF THE STEERING COMMITTEE.

1733
01:23:21,119 --> 01:23:23,488
IF WE DO DECIDE TO DO PROJECTS 

1734
01:23:23,488 --> 01:23:27,692
AT THE IRF FREDERICK THE 

1735
01:23:27,692 --> 01:23:28,960
EXPENSES ARE LIMITED TO PURCHASE

1736
01:23:28,960 --> 01:23:32,464
OF ANIMALS AND IF THERE ARE ANY 

1737
01:23:32,464 --> 01:23:37,135
NON-STANDARD SPECIALTY 

1738
01:23:37,135 --> 01:23:37,402
RE-AGENTS.

1739
01:23:37,402 --> 01:23:39,204
THE BUILDING CONSTRUCTION 

1740
01:23:39,204 --> 01:23:41,273
STARTED IN 2005 AND THE FIRST 

1741
01:23:41,273 --> 01:23:44,643
SERVICES SUPPORT CONTRACT WAS 

1742
01:23:44,643 --> 01:23:48,980
AWARDED IN 2007 TO BATTEL.

1743
01:23:48,980 --> 01:23:53,084
IN 2011 IT ABECAME OPERATIONAL 

1744
01:23:53,084 --> 01:23:55,954
AND IN 2012 LEVEL 4 CONSTRUCTION

1745
01:23:55,954 --> 01:23:58,323
WAS CLEATED IN 2014 CDC SELECT 

1746
01:23:58,323 --> 01:24:01,059
AGENT APPROVAL WAS GRANTED AND 

1747
01:24:01,059 --> 01:24:04,129
IN 2020 THE PROJECT WAS 

1748
01:24:04,129 --> 01:24:08,133
RECOMPETED AND IN 2020 AWARDED.

1749
01:24:08,133 --> 01:24:10,302
THE NEW COMPANY LA LIMA 

1750
01:24:10,302 --> 01:24:11,670
GOVERNMENT SOLUTIONS.

1751
01:24:11,670 --> 01:24:13,438
THE FIRST CONTRACT ENDS IN 

1752
01:24:13,438 --> 01:24:18,243
FEBRUARY OF 2027.

1753
01:24:18,243 --> 01:24:23,448
THIS IS FROM THE COVER OF THE 

1754
01:24:23,448 --> 01:24:25,150
ANNUAL REPORT LISTING 

1755
01:24:25,150 --> 01:24:30,121
ACCOMPLISHMENTS FOR THAT YEAR.

1756
01:24:30,121 --> 01:24:34,493
IT INCLUDES 94 PUBLICATION AND 

1757
01:24:34,493 --> 01:24:36,161
COLLABORATION AGREEMENT AND 

1758
01:24:36,161 --> 01:24:39,097
TRANSFER AGREEMENTS AND 

1759
01:24:39,097 --> 01:24:41,099
PRESENTATIONS AT NATIONAL AND 

1760
01:24:41,099 --> 01:24:41,733
INTERNATIONAL CONFERENCES AND 

1761
01:24:41,733 --> 01:24:47,105
CLINICAL TRIAL SUPPORT FOR STUDY

1762
01:24:47,105 --> 01:24:51,776
IN LIBERIA AND IN THE REPUBLIC 

1763
01:24:51,776 --> 01:24:53,111
OF CONGO.

1764
01:24:53,111 --> 01:24:56,448
I LISTED SOME OF THE MORE HIGH 

1765
01:24:56,448 --> 01:24:57,115
PROFILE PUBLICATIONS IN THE LAST

1766
01:24:57,115 --> 01:24:58,416
COUPLE YEARS TO TRY TO 

1767
01:24:58,416 --> 01:25:01,119
ILLUSTRATE THE DIFFERENT AREAS 

1768
01:25:01,119 --> 01:25:11,530
OF WORK WE FACILITATED.

1769
01:25:17,168 --> 01:25:22,674
THERE'S MRNA VACCINATION AND IT 

1770
01:25:22,674 --> 01:25:27,579
CAN EXPAND CLONALO TYPES 

1771
01:25:27,579 --> 01:25:32,350
UNDETECTABLE OF SARS COV2 

1772
01:25:32,350 --> 01:25:35,620
INFECTION AND PATHOLOGISTS USED 

1773
01:25:35,620 --> 01:25:38,490
SPECIMENS FROM A MONKEY STUDY 

1774
01:25:38,490 --> 01:25:42,394
NOT COMPETED ON THE EBOLA VIRUS 

1775
01:25:42,394 --> 01:25:45,797
TO LOOK AT THE ABNORMALITY AND 

1776
01:25:45,797 --> 01:25:52,537
FOUND THAT EEBL -- EBOLA VIRUS 

1777
01:25:52,537 --> 01:25:54,773
COULD OCCUR AND DISEASE 

1778
01:25:54,773 --> 01:25:58,043
PROGRESSION WAS ASSOCIATED 

1779
01:25:58,043 --> 01:26:01,146
WITHEMWI

1780
01:26:01,146 --> 01:26:06,585
WITHEMWITH 

1781
01:26:06,585 --> 01:26:08,453
HEMATOPOIETIC FAILURE AND THE 

1782
01:26:08,453 --> 01:26:13,892
SECOND WAS IN A COLLABORATION 

1783
01:26:13,892 --> 01:26:18,263
WHERE THEY ISOLATED MONOCLONAL 

1784
01:26:18,263 --> 01:26:19,331
ANTIBODIES TO SARS COV2.

1785
01:26:19,331 --> 01:26:21,132
THE SECOND STUDY WAS CONDUCTED 

1786
01:26:21,132 --> 01:26:25,136
WITH PARTNERS IN AFRICA LOOKING 

1787
01:26:25,136 --> 01:26:27,672
AT PREGNANCY OUTCOMES AFTER 

1788
01:26:27,672 --> 01:26:29,674
EBOLA VIRUS RECOVERY.

1789
01:26:29,674 --> 01:26:32,644
THE FOLLOWING WAS ANOTHER STUDY 

1790
01:26:32,644 --> 01:26:34,279
AND THE LAST ONE WAS A 

1791
01:26:34,279 --> 01:26:35,180
COLLABORATION WITH THE CENTER 

1792
01:26:35,180 --> 01:26:39,718
FOR IMAGING AND INFECTIOUS 

1793
01:26:39,718 --> 01:26:42,587
DISEASE IMAGING AT NIH AND 

1794
01:26:42,587 --> 01:26:48,259
INCLUDED OUR A.I. EXPERT WHO 

1795
01:26:48,259 --> 01:26:51,663
PARTICIPATED IN THAT STUDY THE 

1796
01:26:51,663 --> 01:26:54,466
SUPPORT CONTRACT WILL SERVE AS A

1797
01:26:54,466 --> 01:26:57,135
NATIONAL RESOURCE FOR LEVEL-2 

1798
01:26:57,135 --> 01:26:58,336
LABORATORY WORK.

1799
01:26:58,336 --> 01:27:01,139
IT INCLUDES DEVELOPING ANIMAL 

1800
01:27:01,139 --> 01:27:03,608
MODELS FOR HUMAN DISEASE CAUSED 

1801
01:27:03,608 --> 01:27:09,147
BY HIGHLY PATHOGENIC VIRUSES AND

1802
01:27:09,147 --> 01:27:10,682
CUTTING EDGE METHODS UNDER 

1803
01:27:10,682 --> 01:27:14,252
METHOD OF PATHOGENESIS AND THE 

1804
01:27:14,252 --> 01:27:16,521
EVALUATION OF COUNTER MEASURES 

1805
01:27:16,521 --> 01:27:21,793
TO TREAT DISEASE AND PROVIDES 

1806
01:27:21,793 --> 01:27:25,130
PERSONNEL TO SUPPORT CLINICAL 

1807
01:27:25,130 --> 01:27:30,168
STUDIES IN AFRICA.

1808
01:27:30,168 --> 01:27:34,739
USING A UNIQUE OPERATING MODEL 

1809
01:27:34,739 --> 01:27:35,840
WITH INTRAMURAL AND EXTRAMURAL 

1810
01:27:35,840 --> 01:27:36,141
COMPONENTS.

1811
01:27:36,141 --> 01:27:37,776
WE'RE WORKING TO REVISE THE 

1812
01:27:37,776 --> 01:27:43,181
STATEMENT OF WORK WHERE IT IS 

1813
01:27:43,181 --> 01:27:45,650
NECESSARY TO ADDRESS CHANGED 

1814
01:27:45,650 --> 01:27:48,119
PRIORITIES AND THIS COMES FROM 

1815
01:27:48,119 --> 01:27:51,022
THE MOST RECENT REPORT PROVIDED 

1816
01:27:51,022 --> 01:27:53,158
TO THE GOVERNMENT BY LA LIMA AND

1817
01:27:53,158 --> 01:27:55,126
CHOSE THE WORKFORCE.

1818
01:27:55,126 --> 01:27:57,595
WE HAVE 111 CONTRACT PERSONNEL 

1819
01:27:57,595 --> 01:28:00,498
FROM LA LIMA AND THEIR 

1820
01:28:00,498 --> 01:28:01,132
SUBCONTRACTOR.

1821
01:28:01,132 --> 01:28:05,904
BUT IN ADDITION TO THE WORKFORCE

1822
01:28:05,904 --> 01:28:11,843
THE THERE'S TWO CONTRACTORS FROM

1823
01:28:11,843 --> 01:28:13,545
LIDOS AND FOUR GOVERNMENT FTE 

1824
01:28:13,545 --> 01:28:17,082
INCLUDING ME AND ONE PUBLIC 

1825
01:28:17,082 --> 01:28:19,250
HEALTH OFFICER A HUMAN 

1826
01:28:19,250 --> 01:28:19,984
PATHOLOGIST AND ON SITE SUPPORT 

1827
01:28:19,984 --> 01:28:23,555
FROM THE DIVISION OF CLINICAL 

1828
01:28:23,555 --> 01:28:25,890
RESEARCH OF PROGRAMS AND BUDGET 

1829
01:28:25,890 --> 01:28:31,129
BRANCH AND NIH INFORMATION OF 

1830
01:28:31,129 --> 01:28:33,098
TECHNOLOGY SERVICES AND RESEARCH

1831
01:28:33,098 --> 01:28:35,967
FACILITIES AND CONTRACTED 

1832
01:28:35,967 --> 01:28:37,135
SECURITY GUARDS AND THE NUMBERS 

1833
01:28:37,135 --> 01:28:39,471
AFTER EACH ARE HOW MANY OF THAT 

1834
01:28:39,471 --> 01:28:41,940
PARTICULAR TYPE OF PERSONNEL WE 

1835
01:28:41,940 --> 01:28:43,074
HAVE ON SITE AT THE IRF 

1836
01:28:43,074 --> 01:28:47,412
FREDERICK.

1837
01:28:47,412 --> 01:28:53,118
AGAIN, I VERY MUCH THANK DOCTORS

1838
01:28:53,118 --> 01:29:03,528
PALMER AND BOCKENSTEDT 

1839
01:29:04,129 --> 01:29:04,896
EXPLAINING WHAT I'M SUPPOSED TO 

1840
01:29:04,896 --> 01:29:06,931
DO AND I SPENT THE TIME TRYING 

1841
01:29:06,931 --> 01:29:09,134
TO EXPLAIN WHAT THE 

1842
01:29:09,134 --> 01:29:11,035
IRF-FREDERICK IS BECAUSE I THINK

1843
01:29:11,035 --> 01:29:11,936
A LOT OF PEOPLE SIMPLY DON'T 

1844
01:29:11,936 --> 01:29:17,542
UNDERSTAND HOW WE FIT INTO THE 

1845
01:29:17,542 --> 01:29:24,582
OVER ALL SCHEME OF NIAID AND NIH

1846
01:29:24,582 --> 01:29:28,353
AND HOW WE DIFFER FROM RML.

1847
01:29:28,353 --> 01:29:30,121
WHAT ARE OUR PUBLICATIONS THE 

1848
01:29:30,121 --> 01:29:35,493
SPECTRUM OF THE TYPE OF WORK WE 

1849
01:29:35,493 --> 01:29:46,004
DO AND THE IN THE PICTURE AND 

1850
01:29:48,807 --> 01:29:49,073
ABBREVIATIONS.

1851
01:29:49,073 --> 01:29:50,408
THANK YOU BOTH FOR POINTING OUT 

1852
01:29:50,408 --> 01:29:53,111
TO ME I NEED TO BE A LITTLE 

1853
01:29:53,111 --> 01:29:55,613
CLEARER IN MY PRESENTATIONS.

1854
01:29:55,613 --> 01:29:59,751
ALL IN ALL, THEY WERE BOTH QUITE

1855
01:29:59,751 --> 01:30:01,119
SUPPORTIVE OF CONTINUING THIS 

1856
01:30:01,119 --> 01:30:04,956
PROJECT.

1857
01:30:04,956 --> 01:30:09,127
WITH THAT AIL STOP AND SEE IF 

1858
01:30:09,127 --> 01:30:11,129
ANYBODY HAS ANY QUESTIONS.

1859
01:30:11,129 --> 01:30:13,131
>> THANK YOU, CONNIE.

1860
01:30:13,131 --> 01:30:14,532
THE FLOOR'S.

1861
01:30:14,532 --> 01:30:16,167
TO QUESTIONS.

1862
01:30:16,167 --> 01:30:17,135
QUESTIONS FROM COUNCIL MEMBERS 

1863
01:30:17,135 --> 01:30:27,712
OR ADDITIONAL COMMENTS?

1864
01:30:27,712 --> 01:30:28,346
>> OKAY.

1865
01:30:28,346 --> 01:30:29,147
>> YOU'VE CLARIFIED THE 

1866
01:30:29,147 --> 01:30:30,748
DIFFERENCE BETWEEN THE ROCKY 

1867
01:30:30,748 --> 01:30:31,716
MOUNTAIN LAB AND YOUR LAB.

1868
01:30:31,716 --> 01:30:32,083
THANKS, CONNIE.

1869
01:30:32,083 --> 01:30:39,290
>> THANK YOU.

1870
01:30:39,290 --> 01:30:41,125
OKAY.

1871
01:30:41,125 --> 01:30:43,294
I THINK THAT CONCLUDES OUR -- 

1872
01:30:43,294 --> 01:30:43,995
WE'VE GONE THROUGH THE ENTIRE 

1873
01:30:43,995 --> 01:30:45,630
AGENDA OF CONCEPTS FOR 

1874
01:30:45,630 --> 01:30:46,164
CLEARANCE.

1875
01:30:46,164 --> 01:30:49,634
WE DO NEED TO ASK YOU TO EN TUR 

1876
01:30:49,634 --> 01:30:52,403
YOU'RE VOTE INTO THE ELECTRONIC 

1877
01:30:52,403 --> 01:30:55,740
COUNCIL BOOK THAT IS BOTH 

1878
01:30:55,740 --> 01:30:56,274
COUNCIL MEMBERS REMOTELY 

1879
01:30:56,274 --> 01:30:57,041
PARTICIPATING AS WELL AS THOSE 

1880
01:30:57,041 --> 01:30:57,876
IN THE ROOM.

1881
01:30:57,876 --> 01:31:06,417
THEY WILL COME AFTER YOU IF YOU 

1882
01:31:06,417 --> 01:31:06,651
NEGLECT.

1883
01:31:06,651 --> 01:31:07,185
I THINK OTHERWISE WE ARE 

1884
01:31:07,185 --> 01:31:07,452
ADJOURNED.

1885
01:31:07,452 --> 01:31:17,695
THANK YOU ALL.