WEBVTT 00:00:10.000 --> 00:00:11.000 STANDING BY] 00:00:11.000 --> 00:00:13.000 >>MS. SHAILA SHAHEED: Welcome, 00:00:13.000 --> 00:00:17.000 everyone. Good afternoon Ian. 00:00:17.000 --> 00:00:21.000 We welcome you full art third 00:00:21.000 --> 00:00:26.000 FDABAA day. I my name is Shaila 00:00:26.000 --> 00:00:31.000 Shaheed. Emerging science 00:00:31.000 --> 00:00:33.000 . The program is in R. And D 00:00:33.000 --> 00:00:34.000 contract mechanism where we sew 00:00:34.000 --> 00:00:38.000 LIS at this time proPO prose 00:00:38.000 --> 00:00:42.000 we sew LIS it 00:00:42.000 --> 00:00:44.000 we the program is led 00:00:44.000 --> 00:00:48.000 by can Ier in RA Chada. You 00:00:48.000 --> 00:00:52.000 will hear from her later DOOD. 00:00:52.000 --> 00:00:54.000 today. And also we also have a 00:00:54.000 --> 00:00:57.000 partnership with the contract 00:00:57.000 --> 00:01:01.000 shop. He's here as well. He's 00:01:01.000 --> 00:01:03.000 -- grant supports the contract 00:01:03.000 --> 00:01:06.000 effort that goes into the BAA 00:01:06.000 --> 00:01:08.000 the BAA mechanism. With that 00:01:08.000 --> 00:01:09.000 said, I want to make sure that 00:01:09.000 --> 00:01:11.000 you are all aware that this 00:01:11.000 --> 00:01:13.000 meeting will be recorded and 00:01:13.000 --> 00:01:14.000 it's closed captioned. The 00:01:14.000 --> 00:01:17.000 meeting materials will be 00:01:17.000 --> 00:01:20.000 will be made available on 00:01:20.000 --> 00:01:23.000 on November 21st. The program 00:01:23.000 --> 00:01:25.000 The program launched in 2020. 00:01:25.000 --> 00:01:27.000 So it's been going strong since 00:01:27.000 --> 00:01:29.000 since then and we've received 00:01:29.000 --> 00:01:31.000 about 200 plus submissions 00:01:31.000 --> 00:01:32.000 recently for the optional 00:01:32.000 --> 00:01:39.000 concept paper. So can Ier in RA 00:01:39.000 --> 00:01:41.000 So KEer in RA and the time will 00:01:41.000 --> 00:01:42.000 go through that. We're also 00:01:42.000 --> 00:01:44.000 looking to go over the timeline 00:01:44.000 --> 00:01:46.000 she will go over that. For the 00:01:46.000 --> 00:01:50.000 full proposal submissions that's 00:01:50.000 --> 00:01:53.000 due next year. I think aye 00:01:53.000 --> 00:01:58.000 I think Ian will also cover how 00:01:58.000 --> 00:02:00.000 well we did last year. I think 00:02:00.000 --> 00:02:01.000 we 24 contracts with a value of 00:02:01.000 --> 00:02:03.000 39 million or so. And they 00:02:03.000 --> 00:02:05.000 will do a deeper dive on those. 00:02:05.000 --> 00:02:06.000 We also welcome the partnership 00:02:06.000 --> 00:02:09.000 that we have with the centers 00:02:09.000 --> 00:02:10.000 and offices as you all know, 00:02:10.000 --> 00:02:13.000 we're in the offices of the 00:02:13.000 --> 00:02:15.000 commissioners in the offices of 00:02:15.000 --> 00:02:17.000 sciences and we partnered with 00:02:17.000 --> 00:02:20.000 the -- the centers and offices 00:02:20.000 --> 00:02:23.000 to really enable them to have 00:02:23.000 --> 00:02:24.000 external partnerships on focus 00:02:24.000 --> 00:02:27.000 areas of research for a given 00:02:27.000 --> 00:02:29.000 area. This announcement is 00:02:29.000 --> 00:02:33.000 posted. And we'll be focusing 00:02:33.000 --> 00:02:35.000 on the current announcement 00:02:35.000 --> 00:02:37.000 solicitation's also amended as 00:02:37.000 --> 00:02:39.000 as per request need from the 00:02:39.000 --> 00:02:40.000 centers and offices. With that 00:02:40.000 --> 00:02:41.000 said I want to thank you 00:02:41.000 --> 00:02:44.000 actually the team who put 00:02:44.000 --> 00:02:46.000 together this event there's a 00:02:46.000 --> 00:02:49.000 lot that goes on behind the 00:02:49.000 --> 00:02:53.000 scene. That's the AV team, our 00:02:53.000 --> 00:03:02.000 project manager Ruiz, Jessica, 00:03:02.000 --> 00:03:03.000 Kinerr aand ayian and his team 00:03:03.000 --> 00:03:04.000 . 00:03:04.000 --> 00:03:05.000 >> 00:03:05.000 --> 00:03:06.000 >>IAN WEISS: I'm the branch 00:03:06.000 --> 00:03:07.000 I'm the branch chief for the 00:03:07.000 --> 00:03:09.000 scientific support branch within 00:03:09.000 --> 00:03:11.000 the office of acquisitions and 00:03:11.000 --> 00:03:15.000 grant services here if the FA. 00:03:15.000 --> 00:03:18.000 here at the FDA. 00:03:18.000 --> 00:03:19.000 I'm the touch point for the BAA 00:03:19.000 --> 00:03:22.000 program. And want to do 00:03:22.000 --> 00:03:24.000 And wanted to welcome you to 00:03:24.000 --> 00:03:25.000 today's BAA hopefully it will be 00:03:25.000 --> 00:03:27.000 a valuable experience for 00:03:27.000 --> 00:03:29.000 everybody involved. We'll be 00:03:29.000 --> 00:03:34.000 going over any number of topics 00:03:34.000 --> 00:03:38.000 from the programs and the 00:03:38.000 --> 00:03:40.000 regulatory research charges. 00:03:40.000 --> 00:03:43.000 Just -- the process, the actual 00:03:43.000 --> 00:03:45.000 process of the BAA award process 00:03:45.000 --> 00:03:49.000 and kind of some historical data 00:03:49.000 --> 00:03:50.000 as well. 00:03:50.000 --> 00:03:51.000 So please take advantage of this 00:03:51.000 --> 00:03:52.000 virtual event and the 00:03:52.000 --> 00:03:53.000 opportunities provided to 00:03:53.000 --> 00:03:55.000 understand our mission and meet 00:03:55.000 --> 00:03:58.000 and network with our FDA staff. 00:03:58.000 --> 00:04:00.000 And again this will be recorded 00:04:00.000 --> 00:04:03.000 and be available I think on the 00:04:03.000 --> 00:04:05.000 21st. And I think that's about 00:04:05.000 --> 00:04:08.000 it for me until later on in the 00:04:08.000 --> 00:04:14.000 presentation. 00:04:14.000 --> 00:04:17.000 >> Thank you Shaila, thank you 00:04:17.000 --> 00:04:22.000 Ian. So we can move on to our 00:04:22.000 --> 00:04:24.000 first presentation, Darlese 00:04:24.000 --> 00:04:25.000 . 00:04:25.000 --> 00:04:26.000 >>DR. DARLESE SOLORZANO: 00:04:26.000 --> 00:04:31.000 Sheldon, can you please go ahead 00:04:31.000 --> 00:04:37.000 and play 00:04:37.000 --> 00:04:38.000 ? While our AV support team is 00:04:38.000 --> 00:04:40.000 bringing up the presentation, 00:04:40.000 --> 00:04:42.000 prerecorded presentation, I just 00:04:42.000 --> 00:04:44.000 wanted to say that after the 00:04:44.000 --> 00:04:46.000 presentation we would have a 00:04:46.000 --> 00:04:50.000 5-minute Q & A session. All the 00:04:50.000 --> 00:04:54.000 questions would be specific to 00:04:54.000 --> 00:04:56.000 the presentation from bio. And 00:04:56.000 --> 00:04:57.000 Ms. Darlese is available for 00:04:57.000 --> 00:05:01.000 answering questions. In I 00:05:01.000 --> 00:05:02.000 questions which would not be 00:05:02.000 --> 00:05:03.000 answered during the 5 minutes 00:05:03.000 --> 00:05:06.000 the 5 minutes would be answered 00:05:06.000 --> 00:05:10.000 later either by the Q & A chat 00:05:10.000 --> 00:05:13.000 window or be posted 00:05:13.000 --> 00:05:17.000 on the website as part of the 00:05:17.000 --> 00:05:20.000 meeting material. Thank you 00:05:20.000 --> 00:05:21.000 . 00:05:21.000 --> 00:05:25.000 >>DR. DARLESE SOLORZANO: Hello, 00:05:25.000 --> 00:05:28.000 everyone. My name is Darlese 00:05:28.000 --> 00:05:30.000 . And I'm the program manager 00:05:30.000 --> 00:05:33.000 for the regulatory science 00:05:33.000 --> 00:05:35.000 pilot program. And I am here 00:05:35.000 --> 00:05:37.000 today to give some information 00:05:37.000 --> 00:05:39.000 on the pilot program and how it 00:05:39.000 --> 00:05:49.000 relates to the BAA announcement. 00:05:49.000 --> 00:05:50.000 Before we get started on the 00:05:50.000 --> 00:05:52.000 program, I wanted to give 00:05:52.000 --> 00:05:57.000 everyone the current state of 00:05:57.000 --> 00:06:01.000 biosimilars at FDA 00:06:01.000 --> 00:06:04.000 . So as of 00:06:04.000 --> 00:06:07.000 September 6th, 2024, the FDA 00:06:07.000 --> 00:06:09.000 has 59 SI biosimilar to 17 00:06:09.000 --> 00:06:11.000 reference products of which 15 00:06:11.000 --> 00:06:15.000 are interchangeable and 38 are 00:06:15.000 --> 00:06:19.000 marketed to 10 different 00:06:19.000 --> 00:06:22.000 reference products. SEDAR has 00:06:22.000 --> 00:06:25.000 SEDAR has also received meeting 00:06:25.000 --> 00:06:27.000 requests for 55 reference 00:06:27.000 --> 00:06:30.000 products. So all of this effort 00:06:30.000 --> 00:06:33.000 has resulted in patients having 00:06:33.000 --> 00:06:36.000 access to biosimilars and 00:06:36.000 --> 00:06:39.000 providing nearly 24 billion 00:06:39.000 --> 00:06:40.000 $24 billion in cost savings. 00:06:40.000 --> 00:06:43.000 Which is really the main goal 00:06:43.000 --> 00:06:46.000 for biosimilar development. 00:06:46.000 --> 00:06:48.000 At the bottom of the slide here, 00:06:48.000 --> 00:06:50.000 you will find a link that can 00:06:50.000 --> 00:06:52.000 provide more marketing details. 00:06:52.000 --> 00:06:56.000 As my main focus for today's 00:06:56.000 --> 00:07:01.000 presentation, what we'll be on 00:07:01.000 --> 00:07:07.000 the 5 programs and 00:07:07.000 --> 00:07:09.000 the BAA. 00:07:09.000 --> 00:07:15.000 Now, jumping into some 00:07:15.000 --> 00:07:16.000 information on the BsUFAIII 00:07:16.000 --> 00:07:17.000 regulatory science pilot 00:07:17.000 --> 00:07:21.000 program. So the program was 00:07:21.000 --> 00:07:23.000 created under 00:07:23.000 --> 00:07:27.000 the BsUFA333 commitment letter 00:07:27.000 --> 00:07:29.000 as part of FDA's commitment to 00:07:29.000 --> 00:07:31.000 regulatory decision-making and 00:07:31.000 --> 00:07:32.000 facilitating science-based 00:07:32.000 --> 00:07:34.000 recommendations in the area of 00:07:34.000 --> 00:07:37.000 biosimilar development. 00:07:37.000 --> 00:07:42.000 So the program focuses on 00:07:42.000 --> 00:07:43.000 facilitating ways to improve 00:07:43.000 --> 00:07:44.000 efficiency and biosimilar 00:07:44.000 --> 00:07:45.000 product development and 00:07:45.000 --> 00:07:47.000 advancing the development of 00:07:47.000 --> 00:07:49.000 interchangeable products. 00:07:49.000 --> 00:07:51.000 These two are the demonstration 00:07:51.000 --> 00:07:55.000 projects and/or aims that are 00:07:55.000 --> 00:07:58.000 listed directly under 00:07:58.000 --> 00:08:00.000 the BsUFA III commitment 00:08:00.000 --> 00:08:03.000 letter which I have provided a 00:08:03.000 --> 00:08:06.000 link to below. 00:08:06.000 --> 00:08:08.000 So how do we fulfill the 00:08:08.000 --> 00:08:10.000 demonstration projects listed 00:08:10.000 --> 00:08:13.000 under the commitment letter 00:08:13.000 --> 00:08:15.000 given that they're very broad? 00:08:15.000 --> 00:08:17.000 So in order to do this, at the 00:08:17.000 --> 00:08:21.000 beginning of the pilot program, 00:08:21.000 --> 00:08:22.000 we brought together a forum of 00:08:22.000 --> 00:08:25.000 FDA subject matter experts 00:08:25.000 --> 00:08:28.000 within the respective disMRIPs 00:08:28.000 --> 00:08:29.000 s for biosimilarity and decided 00:08:29.000 --> 00:08:30.000 ciplines for biosimilarity and 00:08:30.000 --> 00:08:34.000 decided to focus the program on 00:08:34.000 --> 00:08:38.000 the composition of the 351KBLA 00:08:38.000 --> 00:08:39.000 BLA package so on the left side 00:08:39.000 --> 00:08:43.000 of the slide you see the 00:08:43.000 --> 00:08:47.000 current composition of the 351k 00:08:47.000 --> 00:08:51.000 BLA which includes clinical 00:08:51.000 --> 00:08:54.000 pharmacology, comparative 00:08:54.000 --> 00:08:56.000 assessment product quality and 00:08:56.000 --> 00:08:59.000 studies. We hope that the 00:08:59.000 --> 00:09:00.000 accumulation of experience, 00:09:00.000 --> 00:09:01.000 policy development and 00:09:01.000 --> 00:09:02.000 information gathered from the 00:09:02.000 --> 00:09:05.000 regulatory science program that 00:09:05.000 --> 00:09:09.000 the potential future of the 3 00:09:09.000 --> 00:09:11.000 the 351kBLA package increase 00:09:11.000 --> 00:09:14.000 its reliance on the DHON 00:09:14.000 --> 00:09:17.000 on the demonstration of 00:09:17.000 --> 00:09:18.000 biosimilarity on analytical data 00:09:18.000 --> 00:09:21.000 and leverage alternatives to 00:09:21.000 --> 00:09:24.000 and/or reduce the size of the 00:09:24.000 --> 00:09:26.000 studies involving human 00:09:26.000 --> 00:09:28.000 subjects. These two were set as 00:09:28.000 --> 00:09:31.000 our program goals. And as part 00:09:31.000 --> 00:09:34.000 of our research road map. 00:09:34.000 --> 00:09:37.000 So the link below provides a 00:09:37.000 --> 00:09:41.000 current -- the current research 00:09:41.000 --> 00:09:43.000 road map for the program 00:09:43.000 --> 00:09:44.000 and as part of our research 00:09:44.000 --> 00:09:45.000 road map. 00:09:45.000 --> 00:09:46.000 So the link below provides a current -- the current research 00:09:46.000 --> 00:09:47.000 road map for the program. So 00:09:47.000 --> 00:09:49.000 So with these program goals 00:09:49.000 --> 00:09:51.000 set, also known as our 00:09:51.000 --> 00:09:54.000 regulatory impact, we were able 00:09:54.000 --> 00:09:56.000 to define research priorities 00:09:56.000 --> 00:09:58.000 under our research road map to 00:09:58.000 --> 00:10:01.000 help facilitate ways in meeting 00:10:01.000 --> 00:10:04.000 our goals. So the first impact 00:10:04.000 --> 00:10:07.000 is increasing the reliance on 00:10:07.000 --> 00:10:10.000 analytical data in demonstration 00:10:10.000 --> 00:10:11.000 of biosimilarity. 00:10:11.000 --> 00:10:14.000 We identified three research 00:10:14.000 --> 00:10:17.000 priorities under this impact 00:10:17.000 --> 00:10:19.000 which are A, characterize 00:10:19.000 --> 00:10:21.000 relationships between product 00:10:21.000 --> 00:10:23.000 quality attributes, so the 00:10:23.000 --> 00:10:25.000 physiochemical or buy I don't 00:10:25.000 --> 00:10:29.000 biological with clinical 00:10:29.000 --> 00:10:31.000 performance. B, explore how 00:10:31.000 --> 00:10:32.000 modernization of analytical 00:10:32.000 --> 00:10:35.000 technologies could better and/or 00:10:35.000 --> 00:10:37.000 more efficiently detect relevant 00:10:37.000 --> 00:10:39.000 quality attributes, and C, 00:10:39.000 --> 00:10:41.000 define best-practices for 00:10:41.000 --> 00:10:45.000 assessing and reporting quality 00:10:45.000 --> 00:10:49.000 attributes. 00:10:49.000 --> 00:10:52.000 As for our second goal or 00:10:52.000 --> 00:10:54.000 regulatory impact number 2 which 00:10:54.000 --> 00:10:56.000 is the development of 00:10:56.000 --> 00:10:58.000 alternatives to and/or reduce 00:10:58.000 --> 00:11:01.000 the size of studies involving 00:11:01.000 --> 00:11:03.000 human participants, we've 00:11:03.000 --> 00:11:07.000 identified three different 00:11:07.000 --> 00:11:09.000 research priorities. So the 00:11:09.000 --> 00:11:10.000 first one is D, develop 00:11:10.000 --> 00:11:14.000 alternatives to the comparative 00:11:14.000 --> 00:11:16.000 clinical immune gentlemen this 00:11:16.000 --> 00:11:18.000 tea assessment, E, define 00:11:18.000 --> 00:11:20.000 approaches that will increase 00:11:20.000 --> 00:11:22.000 feasibility of biosimilar 00:11:22.000 --> 00:11:24.000 development, such as PD 00:11:24.000 --> 00:11:27.000 biomarkers, modelling and 00:11:27.000 --> 00:11:30.000 simulation and last is F, which 00:11:30.000 --> 00:11:31.000 is to identify user interface 00:11:31.000 --> 00:11:34.000 differences that will likely 00:11:34.000 --> 00:11:38.000 lead to clinically meaningful 00:11:38.000 --> 00:11:41.000 differences in use ROR error 00:11:41.000 --> 00:11:42.000 in use error rates or use 00:11:42.000 --> 00:11:43.000 success rates. And again the 00:11:43.000 --> 00:11:45.000 bottom of the slide also 00:11:45.000 --> 00:11:49.000 provides the research road map 00:11:49.000 --> 00:11:51.000 link for you to go over the -- 00:11:51.000 --> 00:11:54.000 the research road map of the 00:11:54.000 --> 00:11:55.000 program as well as take a 00:11:55.000 --> 00:11:56.000 a further look into the 00:11:56.000 --> 00:11:58.000 different research priorities 00:11:58.000 --> 00:11:59.000 that we have. 00:11:59.000 --> 00:12:02.000 So now that I have gone over 00:12:02.000 --> 00:12:04.000 some background information on 00:12:04.000 --> 00:12:07.000 the program and the current 00:12:07.000 --> 00:12:09.000 research priorities, I wanted to 00:12:09.000 --> 00:12:13.000 go over how these priorities 00:12:13.000 --> 00:12:14.000 relate to the 2025 broad 00:12:14.000 --> 00:12:16.000 to the 2025 broad agency 00:12:16.000 --> 00:12:20.000 announcement. So in the table 00:12:20.000 --> 00:12:21.000 that you see here on the slide, 00:12:21.000 --> 00:12:25.000 we have three columns. 00:12:25.000 --> 00:12:28.000 So the first column details the 00:12:28.000 --> 00:12:32.000 BAA priority area of modernizing 00:12:32.000 --> 00:12:34.000 development and evaluation of 00:12:34.000 --> 00:12:36.000 FDA regulator products which 00:12:36.000 --> 00:12:39.000 falls under our program's scope. 00:12:39.000 --> 00:12:42.000 . The second column is the BAA 00:12:42.000 --> 00:12:45.000 topic that we have an interest 00:12:45.000 --> 00:12:49.000 in receiving proposals for which 00:12:49.000 --> 00:12:51.000 are A, alternative methods, C, 00:12:51.000 --> 00:12:53.000 analytical and computational 00:12:53.000 --> 00:12:56.000 methods and H, methods for 00:12:56.000 --> 00:13:01.000 assessing behavioral, economic, 00:13:01.000 --> 00:13:02.000 or human factors. 00:13:02.000 --> 00:13:05.000 The last column details the 00:13:05.000 --> 00:13:08.000 research priority area under the 00:13:08.000 --> 00:13:12.000 BAA topic which includes the 00:13:12.000 --> 00:13:14.000 page number from the -- the -- 00:13:14.000 --> 00:13:16.000 the BAA announcement. 00:13:16.000 --> 00:13:18.000 The language that you see here 00:13:18.000 --> 00:13:21.000 is actually directly derived 00:13:21.000 --> 00:13:24.000 from our research road map. It 00:13:24.000 --> 00:13:26.000 lists out the regulatory impact 00:13:26.000 --> 00:13:30.000 number first and then it's 00:13:30.000 --> 00:13:31.000 followed by the Roman numerals 00:13:31.000 --> 00:13:33.000 that detailed the research 00:13:33.000 --> 00:13:36.000 priority area under that 00:13:36.000 --> 00:13:37.000 regulatory impact. And you can 00:13:37.000 --> 00:13:39.000 reference this back to our 00:13:39.000 --> 00:13:40.000 research road map that I 00:13:40.000 --> 00:13:44.000 provided a link for in the 00:13:44.000 --> 00:13:47.000 previous slide. 00:13:47.000 --> 00:13:50.000 So anyone who is interested in 00:13:50.000 --> 00:13:52.000 submitting a concept paper can 00:13:52.000 --> 00:13:57.000 reference the priorities listed 00:13:57.000 --> 00:14:03.000 under this slide. 00:14:03.000 --> 00:14:05.000 For those of you who are 00:14:05.000 --> 00:14:07.000 interested in submitting a 00:14:07.000 --> 00:14:11.000 concept paper, I wanted to 00:14:11.000 --> 00:14:13.000 provide a quick snapshot of our 00:14:13.000 --> 00:14:15.000 current research portfolio, 00:14:15.000 --> 00:14:16.000 which is what you see in the 00:14:16.000 --> 00:14:19.000 diagram on the slide. We 00:14:19.000 --> 00:14:22.000 currently have 19 awarded 00:14:22.000 --> 00:14:25.000 projects and on the X axis of 00:14:25.000 --> 00:14:27.000 of the diagram, you can see 00:14:27.000 --> 00:14:31.000 which research priorities and 00:14:31.000 --> 00:14:35.000 regulatory impact these projects 00:14:35.000 --> 00:14:38.000 fall under. 00:14:38.000 --> 00:14:40.000 Lastly here is some additional 00:14:40.000 --> 00:14:43.000 information if you want to 00:14:43.000 --> 00:14:46.000 contact the regulatory science 00:14:46.000 --> 00:14:47.000 science pilot program, we do 00:14:47.000 --> 00:14:49.000 have an email box that you can 00:14:49.000 --> 00:14:50.000 reach out to. And then we also 00:14:50.000 --> 00:14:54.000 have a couple of additional 00:14:54.000 --> 00:14:56.000 resources. So we have our 00:14:56.000 --> 00:14:57.000 biosimilar site as well as our 00:14:57.000 --> 00:15:01.000 biosimilars and science and 00:15:01.000 --> 00:15:03.000 research site where you can 00:15:03.000 --> 00:15:05.000 access information such as any 00:15:05.000 --> 00:15:10.000 events that we've had, like with 00:15:10.000 --> 00:15:12.000 different forums like FBI A and 00:15:12.000 --> 00:15:15.000 then we also have listed out 00:15:15.000 --> 00:15:17.000 our annual reports for all of 00:15:17.000 --> 00:15:19.000 our current research projects 00:15:19.000 --> 00:15:23.000 and link is provided here below 00:15:23.000 --> 00:15:26.000 under combined FY22- 00:15:26.000 --> 00:15:27.000 24 regulatory research pilot 00:15:27.000 --> 00:15:29.000 program. Research awards and 00:15:29.000 --> 00:15:32.000 available project reports. This 00:15:32.000 --> 00:15:34.000 details the current progress of 00:15:34.000 --> 00:15:37.000 our awardees for the various 00:15:37.000 --> 00:15:38.000 projects that were listed in the 00:15:38.000 --> 00:15:40.000 previous slide. 00:15:40.000 --> 00:15:43.000 And at this time I would like to 00:15:43.000 --> 00:15:47.000 to thank everyone for listening 00:15:47.000 --> 00:15:51.000 in on my presentation 00:15:51.000 --> 00:15:52.000 . 00:15:52.000 --> 00:15:53.000 >>DR. KINNERA CHADA: Thank you, 00:15:53.000 --> 00:15:54.000 Darlese. 00:15:54.000 --> 00:15:58.000 >>DR. DARLESE SOLORZANO: Thank 00:15:58.000 --> 00:16:01.000 you. I do see I have a question 00:16:01.000 --> 00:16:03.000 posted regarding the FY24 00:16:03.000 --> 00:16:05.000 projects that were announced 00:16:05.000 --> 00:16:07.000 earlier this year. So great 00:16:07.000 --> 00:16:09.000 question. I would like to say 00:16:09.000 --> 00:16:12.000 that we are working on kind of 00:16:12.000 --> 00:16:13.000 reimaging our biosimilar site. 00:16:13.000 --> 00:16:17.000 So later in this year you will 00:16:17.000 --> 00:16:18.000 be seeing our annual reports 00:16:18.000 --> 00:16:20.000 posted on the site for our 00:16:20.000 --> 00:16:24.000 current research portfolio which 00:16:24.000 --> 00:16:26.000 will detail an overview of 00:16:26.000 --> 00:16:27.000 each individual projects I 00:16:27.000 --> 00:16:29.000 think at the time right now we 00:16:29.000 --> 00:16:33.000 only have our annual reports for 00:16:33.000 --> 00:16:34.000 our FY22 awardees. 00:16:34.000 --> 00:16:36.000 But to answer the question, some 00:16:36.000 --> 00:16:40.000 of these projects that are under 00:16:40.000 --> 00:16:42.000 our research portfolio for FY24 00:16:42.000 --> 00:16:44.000 were projects that were funded 00:16:44.000 --> 00:16:46.000 internally and we continue 00:16:46.000 --> 00:16:48.000 funding them as these projects 00:16:48.000 --> 00:16:50.000 were getting -- they had already 00:16:50.000 --> 00:16:51.000 received funding previously and 00:16:51.000 --> 00:16:52.000 they were getting close to the 00:16:52.000 --> 00:16:54.000 to the finish line. So some of 00:16:54.000 --> 00:16:56.000 those projects were rolled into 00:16:56.000 --> 00:16:57.000 the program as we were setting 00:16:57.000 --> 00:16:58.000 up our processes and our 00:16:58.000 --> 00:17:00.000 research road map. And of 00:17:00.000 --> 00:17:03.000 course, our review process has 00:17:03.000 --> 00:17:06.000 has slightly changed as well as 00:17:06.000 --> 00:17:07.000 our research oversight model 00:17:07.000 --> 00:17:09.000 with the revision of the 00:17:09.000 --> 00:17:10.000 research road map which was also 00:17:10.000 --> 00:17:15.000 published in January of this 00:17:15.000 --> 00:17:18.000 year. And I don't see any other 00:17:18.000 --> 00:17:19.000 questions so if you have any 00:17:19.000 --> 00:17:20.000 more questions please feel free 00:17:20.000 --> 00:17:22.000 to put them in the chat box and 00:17:22.000 --> 00:17:25.000 I will try to answer them. 00:17:25.000 --> 00:17:26.000 Thank you. 00:17:26.000 --> 00:17:28.000 >>DR. KINNERA CHADA: Thank you, 00:17:28.000 --> 00:17:32.000 Darlese. Our next presentation 00:17:32.000 --> 00:17:41.000 is from Dr. 00:17:41.000 --> 00:17:43.000 Briget Nugent 00:17:43.000 --> 00:17:44.000 . 00:17:44.000 --> 00:17:45.000 >>DR. BRIDGET NUGENT: Can you 00:17:45.000 --> 00:17:46.000 hear me okay? 00:17:46.000 --> 00:17:47.000 >>DR. KINNERA CHADA: Yes, we 00:17:47.000 --> 00:17:48.000 can. 00:17:48.000 --> 00:17:49.000 >>DR. BRIDGET NUGENT: Great 00:17:49.000 --> 00:17:53.000 Great thanks so much. Good 00:17:53.000 --> 00:17:57.000 afternoon thanks so much for 00:17:57.000 --> 00:17:59.000 giving me the opportunity about 00:17:59.000 --> 00:18:00.000 rare disease research 00:18:00.000 --> 00:18:01.000 priorities. Good you have my 00:18:01.000 --> 00:18:04.000 slides. Thank you. I have a 00:18:04.000 --> 00:18:06.000 science policy analyst on the 00:18:06.000 --> 00:18:08.000 rare diseases team. We have a 00:18:08.000 --> 00:18:10.000 program and policy team that 00:18:10.000 --> 00:18:12.000 sits within the office of new 00:18:12.000 --> 00:18:14.000 drugs and the office of rare 00:18:14.000 --> 00:18:18.000 diseases pediatrics, you're 00:18:18.000 --> 00:18:23.000 logic and reproductive medicine 00:18:23.000 --> 00:18:24.000 and and rare disease and is 00:18:24.000 --> 00:18:26.000 medical genetics. So I just 00:18:26.000 --> 00:18:27.000 want to start by giving some 00:18:27.000 --> 00:18:29.000 some background, the progress 00:18:29.000 --> 00:18:30.000 that we've seen in rare disease 00:18:30.000 --> 00:18:34.000 drug development. 00:18:34.000 --> 00:18:36.000 So there's over 10,000 rare 00:18:36.000 --> 00:18:38.000 diseases that impact around 30 00:18:38.000 --> 00:18:40.000 30 million Americans. And the 00:18:40.000 --> 00:18:44.000 vast majority of these diseases 00:18:44.000 --> 00:18:48.000 have no approved treatments. 00:18:48.000 --> 00:18:49.000 Rare diseases are defined 00:18:49.000 --> 00:18:52.000 in the or fan drug act has 00:18:52.000 --> 00:18:54.000 having fewer than 2 thousand 00:18:54.000 --> 00:18:55.000 2 thousand patients in the 00:18:55.000 --> 00:18:57.000 United States. So each of these 00:18:57.000 --> 00:18:58.000 diseases impacts a relatively 00:18:58.000 --> 00:19:00.000 small population, but 00:19:00.000 --> 00:19:02.000 collectively, there are major 00:19:02.000 --> 00:19:04.000 public health concerns. So they 00:19:04.000 --> 00:19:07.000 impact around one in ten 00:19:07.000 --> 00:19:12.000 Americans. And between 2015 and 00:19:12.000 --> 00:19:15.000 2023, CDER approved 00:19:15.000 --> 00:19:17.000 208 novel drugs for rare 00:19:17.000 --> 00:19:18.000 diseases so about half of all of 00:19:18.000 --> 00:19:20.000 all of the approvals during 00:19:20.000 --> 00:19:23.000 this time frame were for rare 00:19:23.000 --> 00:19:26.000 diseases indications. 00:19:26.000 --> 00:19:29.000 Since the passage of the or fan 00:19:29.000 --> 00:19:32.000 drug act in 1983, FDA has 00:19:32.000 --> 00:19:36.000 approved over 550 drugs and buy 00:19:36.000 --> 00:19:41.000 and biologics 00:19:41.000 --> 00:19:44.000 to treat. Although this is 00:19:44.000 --> 00:19:47.000 remarkable process, we still 00:19:47.000 --> 00:19:48.000 have a long way to go to address 00:19:48.000 --> 00:19:49.000 rare disease patients and their 00:19:49.000 --> 00:19:51.000 families. 00:19:51.000 --> 00:19:54.000 Next slide, please. So this 00:19:54.000 --> 00:19:59.000 figure is just showing rare 00:19:59.000 --> 00:20:04.000 disease drug approval 00:20:04.000 --> 00:20:06.000 by CDer. The number of or fan 00:20:06.000 --> 00:20:10.000 drug new molecular entity 00:20:10.000 --> 00:20:11.000 approvals in green and nonor fan 00:20:11.000 --> 00:20:13.000 approvals in blue. And the 00:20:13.000 --> 00:20:15.000 purple line indicates the 00:20:15.000 --> 00:20:17.000 percentage of or fan drug 00:20:17.000 --> 00:20:18.000 approvals, of all the approval 00:20:18.000 --> 00:20:20.000 within that given year. And the 00:20:20.000 --> 00:20:24.000 take-home message here is 00:20:24.000 --> 00:20:27.000 basically that we've seen a 00:20:27.000 --> 00:20:32.000 a really dramatic rise in the 00:20:32.000 --> 00:20:35.000 number of or fan 00:20:35.000 --> 00:20:36.000 products approved in the United 00:20:36.000 --> 00:20:38.000 States over time, particularly 00:20:38.000 --> 00:20:40.000 in the last five years. 00:20:40.000 --> 00:20:41.000 Next slide, please. So that 00:20:41.000 --> 00:20:45.000 said we still have major 00:20:45.000 --> 00:20:47.000 challenges faced in rare disease 00:20:47.000 --> 00:20:49.000 drug development and these are 00:20:49.000 --> 00:20:50.000 often shared across the rare 00:20:50.000 --> 00:20:51.000 disease drug development space 00:20:51.000 --> 00:20:54.000 so across therapeutic areas. So 00:20:54.000 --> 00:20:59.000 these challenges include poorly. 00:20:59.000 --> 00:21:00.000 ly-understood disease natural 00:21:00.000 --> 00:21:02.000 histories diseases that are 00:21:02.000 --> 00:21:05.000 progressive, serious and 00:21:05.000 --> 00:21:06.000 life-limiting with urgent, unmet 00:21:06.000 --> 00:21:07.000 need. Small patient 00:21:07.000 --> 00:21:10.000 preponderance populations that 00:21:10.000 --> 00:21:14.000 can complicate study design 00:21:14.000 --> 00:21:18.000 options. Clinical and 00:21:18.000 --> 00:21:23.000 genotippic hetero 00:21:23.000 --> 00:21:26.000 genenity. Many programs 00:21:26.000 --> 00:21:27.000 lack solid translational 00:21:27.000 --> 00:21:30.000 science foundations. There's a 00:21:30.000 --> 00:21:33.000 lack of drug development tools 00:21:33.000 --> 00:21:34.000 like clinical outcome measures 00:21:34.000 --> 00:21:38.000 and biomarkers. There's also a 00:21:38.000 --> 00:21:40.000 lack of general precedent for 00:21:40.000 --> 00:21:44.000 drug development for many rare 00:21:44.000 --> 00:21:45.000 diseases. And that can lead 00:21:45.000 --> 00:21:49.000 to uncertainty about the 00:21:49.000 --> 00:21:50.000 clinical meaningful 00:21:50.000 --> 00:21:54.000 ness. 00:21:54.000 --> 00:21:57.000 Next slide, please. In May, 00:21:57.000 --> 00:21:59.000 2022, CDER launched the 00:21:59.000 --> 00:22:09.000 accelerating rare disease cures 00:22:09.000 --> 00:22:11.000 program, AKA the ARC program. 00:22:11.000 --> 00:22:13.000 For people living with rare 00:22:13.000 --> 00:22:15.000 diseases with the mission to 00:22:15.000 --> 00:22:17.000 drive scientific and regulatory 00:22:17.000 --> 00:22:21.000 innovation and engagement. Next 00:22:21.000 --> 00:22:25.000 Next slide, please. The ARC 00:22:25.000 --> 00:22:29.000 program is the CDER- 00:22:29.000 --> 00:22:32.000 wide program with the office of 00:22:32.000 --> 00:22:34.000 new drugs and center director 00:22:34.000 --> 00:22:37.000 and translational science. So 00:22:37.000 --> 00:22:40.000 this affects folks who are close 00:22:40.000 --> 00:22:41.000 toast regulatory review. The 00:22:41.000 --> 00:22:43.000 ARC program is managed by the 00:22:43.000 --> 00:22:46.000 rare diseases team, the THAEM 00:22:46.000 --> 00:22:47.000 teem that I am a part of. And 00:22:47.000 --> 00:22:52.000 this team leads and facile 00:22:52.000 --> 00:22:53.000 facilitates rare disease 00:22:53.000 --> 00:22:56.000 policy and programming and we 00:22:56.000 --> 00:22:59.000 we fulfilled commitments for 00:22:59.000 --> 00:23:00.000 team teem that I am a part of. 00:23:00.000 --> 00:23:01.000 And this team leads and 00:23:01.000 --> 00:23:02.000 facilitates rare disease policy and programming and we fulfilled 00:23:02.000 --> 00:23:03.000 commitments for drugs and rare 00:23:03.000 --> 00:23:04.000 diseases. 00:23:04.000 --> 00:23:05.000 So now I'm going to get into our 00:23:05.000 --> 00:23:11.000 research priorities. So CDER 00:23:11.000 --> 00:23:17.000 ARC's priorities seeks 00:23:17.000 --> 00:23:18.000 to development and policy. ARC 00:23:18.000 --> 00:23:20.000 is interested in supporting 00:23:20.000 --> 00:23:21.000 scientific research that can 00:23:21.000 --> 00:23:25.000 change or contribute to 00:23:25.000 --> 00:23:29.000 regulatory knowledge, practice, 00:23:29.000 --> 00:23:32.000 or methodologies to benefit 00:23:32.000 --> 00:23:33.000 rare disease drug development, 00:23:33.000 --> 00:23:35.000 research that supports 00:23:35.000 --> 00:23:39.000 development of drug products and 00:23:39.000 --> 00:23:41.000 and practices for safe and 00:23:41.000 --> 00:23:42.000 effective products to benefit 00:23:42.000 --> 00:23:43.000 persons with rare disease and is 00:23:43.000 --> 00:23:45.000 research that advances 00:23:45.000 --> 00:23:48.000 evaluation and regulatory review 00:23:48.000 --> 00:23:51.000 of drugs for rare diseases. In 00:23:51.000 --> 00:23:52.000 . Next slide, please. Thank 00:23:52.000 --> 00:23:56.000 you. 00:23:56.000 --> 00:23:59.000 So for this fiscal year. ARC is 00:23:59.000 --> 00:24:02.000 rest interested in research in 00:24:02.000 --> 00:24:03.000 the following areas and they all 00:24:03.000 --> 00:24:04.000 fall under charge 1 of the broad 00:24:04.000 --> 00:24:07.000 agency announcement. 00:24:07.000 --> 00:24:10.000 So alternative methods to 00:24:10.000 --> 00:24:13.000 support regulatory assessment of 00:24:13.000 --> 00:24:14.000 drug efficacy and safety. 00:24:14.000 --> 00:24:17.000 Analytical and comp 00:24:17.000 --> 00:24:20.000 computational methods such as 00:24:20.000 --> 00:24:22.000 modelling and simulation 00:24:22.000 --> 00:24:23.000 approaches can aaccount for 00:24:23.000 --> 00:24:24.000 common challenges and rare 00:24:24.000 --> 00:24:28.000 diseases that I mentioned 00:24:28.000 --> 00:24:33.000 earlier, such as patient hetero 00:24:33.000 --> 00:24:37.000 geneity and small PAESH 00:24:37.000 --> 00:24:41.000 small patient populations. 00:24:41.000 --> 00:24:45.000 . Diagnosis for support finding 00:24:45.000 --> 00:24:48.000 and efficacy and safety of rare 00:24:48.000 --> 00:24:50.000 disease drugs. Development and 00:24:50.000 --> 00:24:51.000 characterization of novel 00:24:51.000 --> 00:24:54.000 functional assessments like 00:24:54.000 --> 00:24:56.000 clinical outcome assessments and 00:24:56.000 --> 00:24:58.000 digital health tech based 00:24:58.000 --> 00:25:00.000 assessments that can be used for 00:25:00.000 --> 00:25:03.000 rare disease drug development 00:25:03.000 --> 00:25:06.000 . Research on complex and novel 00:25:06.000 --> 00:25:08.000 trial designs. So this can 00:25:08.000 --> 00:25:09.000 include natural history studies 00:25:09.000 --> 00:25:11.000 to inform patient selection for 00:25:11.000 --> 00:25:14.000 trials and inform trial end 00:25:14.000 --> 00:25:16.000 points as well as complex 00:25:16.000 --> 00:25:17.000 innovative trial designs and 00:25:17.000 --> 00:25:19.000 analysis approaches. And 00:25:19.000 --> 00:25:21.000 finally, methods to support and 00:25:21.000 --> 00:25:24.000 expedite rare disease drug 00:25:24.000 --> 00:25:26.000 development using real-world 00:25:26.000 --> 00:25:30.000 data such as patient registries. 00:25:30.000 --> 00:25:32.000 Next slide, please. So I like 00:25:32.000 --> 00:25:35.000 to conclude but also encourage 00:25:35.000 --> 00:25:37.000 you to collect with the ARC 00:25:37.000 --> 00:25:40.000 program by scanning these QR 00:25:40.000 --> 00:25:43.000 codes. We're just going the old 00:25:43.000 --> 00:25:46.000 fashioned way and visiting our 00:25:46.000 --> 00:25:50.000 website, signing up for our news 00:25:50.000 --> 00:25:55.000 news letter and our website has 00:25:55.000 --> 00:25:59.000 links to some -- some outcomes 00:25:59.000 --> 00:26:01.000 that we've recently produced to 00:26:01.000 --> 00:26:04.000 advance and empower rare disease 00:26:04.000 --> 00:26:08.000 drug developers program, AKA 00:26:08.000 --> 00:26:10.000 AKA leader 3D as well as our 00:26:10.000 --> 00:26:13.000 2024 annual report. 00:26:13.000 --> 00:26:15.000 So these resources can kind of 00:26:15.000 --> 00:26:18.000 give you a sense of the work 00:26:18.000 --> 00:26:19.000 of the work that we've done 00:26:19.000 --> 00:26:21.000 what we've heard from our stake 00:26:21.000 --> 00:26:24.000 holders what our priorities are, 00:26:24.000 --> 00:26:26.000 what our accomplishments have 00:26:26.000 --> 00:26:29.000 been and our initiatives to date 00:26:29.000 --> 00:26:30.000 and moving forward. So with 00:26:30.000 --> 00:26:32.000 that I would like to thank you 00:26:32.000 --> 00:26:36.000 for your attention and I'd be 00:26:36.000 --> 00:26:41.000 happy to answer questions 00:26:41.000 --> 00:26:42.000 . And if there are no 00:26:42.000 --> 00:26:43.000 questions, I'm happy to follow 00:26:43.000 --> 00:26:48.000 up with anybody who thinks of 00:26:48.000 --> 00:26:51.000 any questions later 00:26:51.000 --> 00:26:53.000 . 00:26:53.000 --> 00:26:54.000 >>DR. KINNERA CHADA: Thank you. 00:26:54.000 --> 00:26:55.000 00:26:55.000 --> 00:26:56.000 >>DR. BRIDGET NUGENT: Sure, 00:26:56.000 --> 00:26:57.000 thank you. 00:26:57.000 --> 00:26:58.000 >>DR. KINNERA CHADA: We are 00:26:58.000 --> 00:27:00.000 going to move forward with our 00:27:00.000 --> 00:27:03.000 next presentation which would be 00:27:03.000 --> 00:27:04.000 Michele Lee. She will be 00:27:04.000 --> 00:27:06.000 talking about research 00:27:06.000 --> 00:27:07.000 priorities. 00:27:07.000 --> 00:27:09.000 >>DR. MICHELE LEE: Okay, great. 00:27:09.000 --> 00:27:11.000 Can you hear me? 00:27:11.000 --> 00:27:12.000 >>DR. KINNERA CHADA: Yes, we 00:27:12.000 --> 00:27:15.000 can. 00:27:15.000 --> 00:27:29.000 >>DR. MICHELE LEE: Awesome 00:27:29.000 --> 00:27:31.000 . Okay, great. So good 00:27:31.000 --> 00:27:34.000 afternoon. My name is Dr. 00:27:34.000 --> 00:27:36.000 Michele Lee I'm the team lead 00:27:36.000 --> 00:27:38.000 for regulatory science programs 00:27:38.000 --> 00:27:39.000 with the division of 00:27:39.000 --> 00:27:42.000 partnerships and innovation, 00:27:42.000 --> 00:27:44.000 office of equity and development 00:27:44.000 --> 00:27:48.000 in CDRH I will be briefly 00:27:48.000 --> 00:27:51.000 highlighting areas of interest 00:27:51.000 --> 00:27:55.000 to CDRH. Please note this OBL 00:27:55.000 --> 00:27:56.000 highlights some of the areas of 00:27:56.000 --> 00:27:59.000 research. So for more 00:27:59.000 --> 00:28:00.000 information please refer to the 00:28:00.000 --> 00:28:04.000 full document. While this 00:28:04.000 --> 00:28:08.000 presentations focuses on BAAs we 00:28:08.000 --> 00:28:10.000 on BAAs we at CDRH are focuses 00:28:10.000 --> 00:28:15.000 on many collaborations and 00:28:15.000 --> 00:28:19.000 partnerships like 00:28:19.000 --> 00:28:23.000 CERSI we look forward to 00:28:23.000 --> 00:28:24.000 working with others to advance 00:28:24.000 --> 00:28:27.000 the science. 00:28:27.000 --> 00:28:29.000 So this slide displays the main 00:28:29.000 --> 00:28:30.000 categories of research topic 00:28:30.000 --> 00:28:32.000 areas I will be highlighting 00:28:32.000 --> 00:28:34.000 today. Patient-centered 00:28:34.000 --> 00:28:36.000 development for the proactive 00:28:36.000 --> 00:28:37.000 engagement of patient as 00:28:37.000 --> 00:28:40.000 partners throughout the life 00:28:40.000 --> 00:28:42.000 cycle of medical device. 00:28:42.000 --> 00:28:45.000 Digital technologies or 00:28:45.000 --> 00:28:47.000 technologies that use computing 00:28:47.000 --> 00:28:49.000 plat A platforms SOEF wares and 00:28:49.000 --> 00:28:50.000 sensors for health care and 00:28:50.000 --> 00:28:53.000 health use. Medical device 00:28:53.000 --> 00:28:56.000 innovation, through the total 00:28:56.000 --> 00:28:59.000 product life cycle add viewsry 00:28:59.000 --> 00:29:00.000 program or TAP, to provide early 00:29:00.000 --> 00:29:02.000 frequent and strategic 00:29:02.000 --> 00:29:03.000 communication between device 00:29:03.000 --> 00:29:04.000 softwares and sensors for health 00:29:04.000 --> 00:29:05.000 care and health use. Medical 00:29:05.000 --> 00:29:06.000 device innovation, through the 00:29:06.000 --> 00:29:07.000 total product life cycle add 00:29:07.000 --> 00:29:08.000 viewsry program or TAP, to provide early frequent and 00:29:08.000 --> 00:29:09.000 strategic communication between 00:29:09.000 --> 00:29:10.000 device developers and FAD and 00:29:10.000 --> 00:29:13.000 FDA and VAPSing 00:29:13.000 --> 00:29:14.000 FDA and advancing health equity 00:29:14.000 --> 00:29:16.000 across diverse population and 00:29:16.000 --> 00:29:18.000 groups. I would also like to 00:29:18.000 --> 00:29:24.000 mention some high-level 00:29:24.000 --> 00:29:28.000 statistics. In FY23, CDRH 00:29:28.000 --> 00:29:30.000 awarded 8 proposals with a total 00:29:30.000 --> 00:29:33.000 of 6 hundred and 90 thousand 00:29:33.000 --> 00:29:34.000 $690,000. In 24, awarded 00:29:34.000 --> 00:29:36.000 several proposals with an 00:29:36.000 --> 00:29:37.000 average of 8 hundred and 40 00:29:37.000 --> 00:29:38.000 $840,000. So you will notice 00:29:38.000 --> 00:29:40.000 that we've primarily awarded 00:29:40.000 --> 00:29:42.000 contracts less than a million 00:29:42.000 --> 00:29:45.000 dollars total in recent years 00:29:45.000 --> 00:29:47.000 and are likely to continue that 00:29:47.000 --> 00:29:49.000 trend moving forward. While 00:29:49.000 --> 00:29:51.000 we've awarded both single year 00:29:51.000 --> 00:29:55.000 and multiple year contracts it 00:29:55.000 --> 00:29:58.000 can be challenging 00:29:58.000 --> 00:29:59.000 to anticipate future funding. 00:29:59.000 --> 00:30:01.000 Please also keep in mind if your 00:30:01.000 --> 00:30:04.000 project will involve surveying 00:30:04.000 --> 00:30:07.000 ten or more public respondents 00:30:07.000 --> 00:30:08.000 it may recall paperwork 00:30:08.000 --> 00:30:10.000 reduction act approval and you 00:30:10.000 --> 00:30:13.000 should account for an average 00:30:13.000 --> 00:30:16.000 of nine months additional for 00:30:16.000 --> 00:30:18.000 the project time line before the 00:30:18.000 --> 00:30:19.000 survey can be initiated. 00:30:19.000 --> 00:30:22.000 So let's begin with 00:30:22.000 --> 00:30:23.000 patient-centered development and 00:30:23.000 --> 00:30:27.000 more specifically, clinical 00:30:27.000 --> 00:30:30.000 outcome assessments. Or COD 00:30:30.000 --> 00:30:33.000 COD they describe how a patient 00:30:33.000 --> 00:30:35.000 feels or survives can be 00:30:35.000 --> 00:30:39.000 provided by a health care 00:30:39.000 --> 00:30:41.000 provider or I patient selves the 00:30:41.000 --> 00:30:42.000 focus has been on 00:30:42.000 --> 00:30:43.000 patient-reported outcomes. 00:30:43.000 --> 00:30:45.000 We're interested in research 00:30:45.000 --> 00:30:48.000 that focuses on modifying or 00:30:48.000 --> 00:30:50.000 adapting COA instruments for new 00:30:50.000 --> 00:30:51.000 situations like different 00:30:51.000 --> 00:30:53.000 subpopulations, different 00:30:53.000 --> 00:30:54.000 regulatory uses or intended uses 00:30:54.000 --> 00:30:55.000 . 00:30:55.000 --> 00:30:58.000 We're also interested in the 00:30:58.000 --> 00:31:00.000 combined use COAs and 00:31:00.000 --> 00:31:02.000 patient-generated health data in 00:31:02.000 --> 00:31:05.000 clinical data sets especially 00:31:05.000 --> 00:31:06.000 the use of AI to examine these 00:31:06.000 --> 00:31:08.000 datasets. 00:31:08.000 --> 00:31:10.000 We're also interested in better 00:31:10.000 --> 00:31:13.000 identifying and understanding 00:31:13.000 --> 00:31:16.000 known biases that exist for 00:31:16.000 --> 00:31:20.000 for patient-reported OUKS for 00:31:20.000 --> 00:31:21.000 example the placebo effect and 00:31:21.000 --> 00:31:23.000 the patient preferences in 00:31:23.000 --> 00:31:24.000 outcome for example the placebo 00:31:24.000 --> 00:31:25.000 effect and the patient 00:31:25.000 --> 00:31:26.000 preferences in benefit/risk 00:31:26.000 --> 00:31:30.000 assessments particularly for 00:31:30.000 --> 00:31:34.000 populations that have been hiss 00:31:34.000 --> 00:31:37.000 THOERcally underserved and are 00:31:37.000 --> 00:31:38.000 torically underserved and are 00:31:38.000 --> 00:31:39.000 nigh minority communities. From 00:31:39.000 --> 00:31:40.000 medical device development 00:31:40.000 --> 00:31:43.000 through regulation and device 00:31:43.000 --> 00:31:45.000 use. CDRH has released guidance 00:31:45.000 --> 00:31:47.000 on the inclusion of patient 00:31:47.000 --> 00:31:49.000 preference information or PPI 00:31:49.000 --> 00:31:50.000 and patient-reported outcomes in 00:31:50.000 --> 00:31:51.000 premarket submissions and we're 00:31:51.000 --> 00:31:54.000 interested in these and other 00:31:54.000 --> 00:31:55.000 validated methods for collecting 00:31:55.000 --> 00:31:57.000 patient input and experience 00:31:57.000 --> 00:31:58.000 data for use and device 00:31:58.000 --> 00:31:59.000 evaluation. 00:31:59.000 --> 00:32:00.000 Patient preference information 00:32:00.000 --> 00:32:02.000 can clarify what benefits and 00:32:02.000 --> 00:32:04.000 risks are most important to 00:32:04.000 --> 00:32:05.000 PAESHLGTs. Until the first 00:32:05.000 --> 00:32:08.000 patients. Until the first 00:32:08.000 --> 00:32:09.000 bullet, I've included a link to 00:32:09.000 --> 00:32:11.000 a CDRH web page that list 00:32:11.000 --> 00:32:13.000 specific areas both by medical 00:32:13.000 --> 00:32:15.000 by medical speciality and broad 00:32:15.000 --> 00:32:17.000 category, such as chronic 00:32:17.000 --> 00:32:19.000 diseases or digital health 00:32:19.000 --> 00:32:21.000 technologies that we are 00:32:21.000 --> 00:32:22.000 prioritizing while I won't read 00:32:22.000 --> 00:32:24.000 out the bullets something I 00:32:24.000 --> 00:32:26.000 would like to point out is we're 00:32:26.000 --> 00:32:28.000 specifically interested of the 00:32:28.000 --> 00:32:30.000 analysis of the bolded factors 00:32:30.000 --> 00:32:33.000 in publicly available 00:32:33.000 --> 00:32:35.000 information information such as 00:32:35.000 --> 00:32:38.000 those public workshops or 00:32:38.000 --> 00:32:40.000 meetings that other agencies 00:32:40.000 --> 00:32:42.000 have held publications or data 00:32:42.000 --> 00:32:43.000 setsets from generative AI 00:32:43.000 --> 00:32:46.000 we're not looking to conduct new 00:32:46.000 --> 00:32:48.000 studies to generate new data but 00:32:48.000 --> 00:32:49.000 rather more interested in 00:32:49.000 --> 00:32:51.000 investigation of information 00:32:51.000 --> 00:32:52.000 that's already out there about 00:32:52.000 --> 00:32:57.000 what we're consistently hearing 00:32:57.000 --> 00:32:58.000 from patients. Next slide 00:32:58.000 --> 00:32:59.000 . 00:32:59.000 --> 00:33:01.000 The technology that helps us 00:33:01.000 --> 00:33:04.000 capture, transmit and analyze 00:33:04.000 --> 00:33:08.000 real-world data for DIMGal 00:33:08.000 --> 00:33:10.000 digital health technologies or 00:33:10.000 --> 00:33:13.000 DHTs we're interest the in the 00:33:13.000 --> 00:33:15.000 role that these can play in 00:33:15.000 --> 00:33:16.000 performance and monitoring. In 00:33:16.000 --> 00:33:18.000 particular we're interested in 00:33:18.000 --> 00:33:20.000 research 0 on tools and 00:33:20.000 --> 00:33:22.000 methodologies to monitor and 00:33:22.000 --> 00:33:25.000 evaluate the real-world 00:33:25.000 --> 00:33:26.000 performance of artificial 00:33:26.000 --> 00:33:28.000 intelligence technologies we've 00:33:28.000 --> 00:33:30.000 included this large in both 00:33:30.000 --> 00:33:31.000 charge 1 and 2 because we're 00:33:31.000 --> 00:33:34.000 interested in applications for 00:33:34.000 --> 00:33:39.000 both premarket and postmarket. 00:33:39.000 --> 00:33:40.000 Next slide. Artificial 00:33:40.000 --> 00:33:43.000 intelligence and machine 00:33:43.000 --> 00:33:44.000 learning are a RALDly-growing 00:33:44.000 --> 00:33:45.000 field that are being 00:33:45.000 --> 00:33:46.000 incorporated into more and more 00:33:46.000 --> 00:33:49.000 medical device technologies and 00:33:49.000 --> 00:33:50.000 health care applications to help 00:33:50.000 --> 00:33:53.000 support our mission of ensuring 00:33:53.000 --> 00:33:55.000 that devices using this TOEK 00:33:55.000 --> 00:33:59.000 technologies are safe and EK 00:33:59.000 --> 00:34:00.000 and EKfective we're interested 00:34:00.000 --> 00:34:01.000 in performance, especially 00:34:01.000 --> 00:34:04.000 around techniques that manage 00:34:04.000 --> 00:34:06.000 bias that may be deuced to or 00:34:06.000 --> 00:34:09.000 inherent in AI or machine 00:34:09.000 --> 00:34:10.000 machine devices. Similarly 00:34:10.000 --> 00:34:11.000 we're interested in research 00:34:11.000 --> 00:34:13.000 that develops tool OS 00:34:13.000 --> 00:34:16.000 methodologies to evaluate and 00:34:16.000 --> 00:34:18.000 ensure high-quality performance 00:34:18.000 --> 00:34:20.000 of large language models or deep 00:34:20.000 --> 00:34:22.000 learning generative AI models 00:34:22.000 --> 00:34:24.000 particularly those that can 00:34:24.000 --> 00:34:26.000 enable robust and postmarket 00:34:26.000 --> 00:34:28.000 monitoring of devices. Next 00:34:28.000 --> 00:34:30.000 Next slide. 00:34:30.000 --> 00:34:31.000 Next I would like to talk about 00:34:31.000 --> 00:34:33.000 our center's interest in 00:34:33.000 --> 00:34:35.000 supporting medical device inknow 00:34:35.000 --> 00:34:37.000 VAEGS. We recognize that 00:34:37.000 --> 00:34:38.000 there's often a gap that occurs 00:34:38.000 --> 00:34:40.000 between a marketing 00:34:40.000 --> 00:34:42.000 authorization and actual public 00:34:42.000 --> 00:34:43.000 use and a adoption of a medical 00:34:43.000 --> 00:34:45.000 device and this gap can 00:34:45.000 --> 00:34:47.000 sometimes cause significant 00:34:47.000 --> 00:34:50.000 challenges for medical device 00:34:50.000 --> 00:34:52.000 innovators or reduce access of 00:34:52.000 --> 00:34:53.000 of the public to these 00:34:53.000 --> 00:34:55.000 technologies there are a variety 00:34:55.000 --> 00:34:57.000 of reasons involving different 00:34:57.000 --> 00:35:00.000 key players in the ecosystem 00:35:00.000 --> 00:35:04.000 that influence the length of 00:35:04.000 --> 00:35:08.000 this GRAP for example work flow 00:35:08.000 --> 00:35:10.000 adoption prevention or... 00:35:10.000 --> 00:35:15.000 reimbursement of a device. 00:35:15.000 --> 00:35:18.000 . We want solutions 00:35:18.000 --> 00:35:19.000 by downstream authorization and 00:35:19.000 --> 00:35:22.000 generates ways to incorporate 00:35:22.000 --> 00:35:23.000 these requirements into methods 00:35:23.000 --> 00:35:26.000 upstream device developments 00:35:26.000 --> 00:35:28.000 like pivotal trial protocols we 00:35:28.000 --> 00:35:29.000 we believe that this type of 00:35:29.000 --> 00:35:30.000 research coupled with 00:35:30.000 --> 00:35:33.000 communication supporting 00:35:33.000 --> 00:35:36.000 programs like the TAP program 00:35:36.000 --> 00:35:37.000 will help us getting our 00:35:37.000 --> 00:35:40.000 much-needed technologies into 00:35:40.000 --> 00:35:41.000 the hands of patients faster. 00:35:41.000 --> 00:35:45.000 Next slide. 00:35:45.000 --> 00:35:47.000 Advancing health equity is an 00:35:47.000 --> 00:35:49.000 overarching goal and there are 00:35:49.000 --> 00:35:51.000 many areas of research in 00:35:51.000 --> 00:35:52.000 achieving this goal of meeting 00:35:52.000 --> 00:35:54.000 health care needs. We recognize 00:35:54.000 --> 00:35:56.000 that sometimes there's a lack of 00:35:56.000 --> 00:35:59.000 of evidence to know whether an 00:35:59.000 --> 00:36:01.000 an existing product benefits 00:36:01.000 --> 00:36:04.000 one demographic group similarly 00:36:04.000 --> 00:36:06.000 to others and deserts persists 00:36:06.000 --> 00:36:10.000 that conditions that 00:36:10.000 --> 00:36:11.000 predominantly affect diverse 00:36:11.000 --> 00:36:13.000 populations. That's why we're 00:36:13.000 --> 00:36:17.000 interested in interventions 00:36:17.000 --> 00:36:21.000 specifically designed in diverse 00:36:21.000 --> 00:36:25.000 populations for example using 00:36:25.000 --> 00:36:27.000 digital health technologies or 00:36:27.000 --> 00:36:29.000 procedures to improve 00:36:29.000 --> 00:36:32.000 participation from 00:36:32.000 --> 00:36:33.000 underrepresented subgroups. 00:36:33.000 --> 00:36:34.000 Keep in mind that diverse or 00:36:34.000 --> 00:36:37.000 underrepresented population are 00:36:37.000 --> 00:36:39.000 not only limbed to racial or 00:36:39.000 --> 00:36:41.000 ethic minorities but can also 00:36:41.000 --> 00:36:45.000 include rural populations 00:36:45.000 --> 00:36:46.000 pediatric or Jer I can't trick 00:36:46.000 --> 00:36:49.000 population or tribal populations 00:36:49.000 --> 00:36:51.000 we're also interested in study 00:36:51.000 --> 00:36:54.000 design and conduct. For example 00:36:54.000 --> 00:36:57.000 how do we retain subjects or 00:36:57.000 --> 00:36:59.000 reduce the burden once they are 00:36:59.000 --> 00:37:01.000 enrolled and not only are we 00:37:01.000 --> 00:37:05.000 interested in the interventions 00:37:05.000 --> 00:37:07.000 them THELTSZ but also tools how 00:37:07.000 --> 00:37:12.000 do we evaluate the impact of 00:37:12.000 --> 00:37:13.000 health but also tools how do we 00:37:13.000 --> 00:37:14.000 evaluate the impact of these 00:37:14.000 --> 00:37:15.000 interventions. It doesn't stop 00:37:15.000 --> 00:37:16.000 at the development stage but 00:37:16.000 --> 00:37:17.000 also involves continual 00:37:17.000 --> 00:37:19.000 observation and understanding of 00:37:19.000 --> 00:37:21.000 how devices are actually used by 00:37:21.000 --> 00:37:23.000 patients in their daily life 00:37:23.000 --> 00:37:24.000 routines. Even with the most 00:37:24.000 --> 00:37:28.000 thorough product design there 00:37:28.000 --> 00:37:31.000 there may be anticipated 00:37:31.000 --> 00:37:33.000 challenges when they integrate 00:37:33.000 --> 00:37:35.000 into their teams and the 00:37:35.000 --> 00:37:37.000 consequences range from poor 00:37:37.000 --> 00:37:39.000 adherence to prescribed device 00:37:39.000 --> 00:37:41.000 therapy in the intended 00:37:41.000 --> 00:37:42.000 populations to barriers do 00:37:42.000 --> 00:37:44.000 access for certain subgroups who 00:37:44.000 --> 00:37:45.000 are unable to successfully use 00:37:45.000 --> 00:37:48.000 the device. 00:37:48.000 --> 00:37:49.000 And that's why CDRH is 00:37:49.000 --> 00:37:50.000 interested in supporting 00:37:50.000 --> 00:37:53.000 research that seeks to gather 00:37:53.000 --> 00:37:54.000 input on and improve upon users 00:37:54.000 --> 00:37:58.000 experience of devices especially 00:37:58.000 --> 00:38:01.000 in underrepresented pediatric, 00:38:01.000 --> 00:38:03.000 elderly, sex-specific or rural 00:38:03.000 --> 00:38:05.000 and trial populations. Next 00:38:05.000 --> 00:38:06.000 slide. So that's it. Happy to 00:38:06.000 --> 00:38:10.000 answer any questions that you 00:38:10.000 --> 00:38:19.000 have. 00:38:19.000 --> 00:38:22.000 I will follow up on questions 00:38:22.000 --> 00:38:24.000 via email. And I don't think I 00:38:24.000 --> 00:38:26.000 see any questions, so happy to 00:38:26.000 --> 00:38:28.000 move forward to the next 00:38:28.000 --> 00:38:29.000 presentation. 00:38:29.000 --> 00:38:30.000 >>DR. KINNERA CHADA: Thank you, 00:38:30.000 --> 00:38:34.000 Michele. Our next presenter is 00:38:34.000 --> 00:38:36.000 Dr. Robert Orr from office of 00:38:36.000 --> 00:38:38.000 regulatory and emerging 00:38:38.000 --> 00:38:42.000 sciences. He will be presenting 00:38:42.000 --> 00:38:50.000 on medical counter measures 00:38:50.000 --> 00:38:51.000 . Can you hear me okay? 00:38:51.000 --> 00:38:52.000 >>DR. KINNERA CHADA: Yes, we 00:38:52.000 --> 00:38:53.000 can. 00:38:53.000 --> 00:38:55.000 >>DR. ROBERT ORR: Wonderful, 00:38:55.000 --> 00:38:57.000 all right. Okay. Well, thank 00:38:57.000 --> 00:38:58.000 you so much for the introduction 00:38:58.000 --> 00:39:00.000 and thank you for the 00:39:00.000 --> 00:39:03.000 opportunity to talk today. I'm 00:39:03.000 --> 00:39:08.000 Robert Orr I'm a product manager 00:39:08.000 --> 00:39:12.000 and I am a biologist for the 00:39:12.000 --> 00:39:14.000 for the office of 00:39:14.000 --> 00:39:18.000 ORES preparedness research 00:39:18.000 --> 00:39:19.000 staff. Next slide, please. 00:39:19.000 --> 00:39:21.000 Sorry, next slide. Oh, thank 00:39:21.000 --> 00:39:24.000 you. 00:39:24.000 --> 00:39:28.000 So some -- before we begin and 00:39:28.000 --> 00:39:29.000 get into the depth about the 00:39:29.000 --> 00:39:32.000 medical counter measures 00:39:32.000 --> 00:39:33.000 initiative I do have a quick 00:39:33.000 --> 00:39:34.000 administrative update that I 00:39:34.000 --> 00:39:37.000 need to share. 00:39:37.000 --> 00:39:40.000 So previously, as in prior years 00:39:40.000 --> 00:39:44.000 of the FDABAA, the medical 00:39:44.000 --> 00:39:45.000 counter measures initiative or 00:39:45.000 --> 00:39:48.000 MCMI was supported by the FDA 00:39:48.000 --> 00:39:52.000 office of counter terrortism and 00:39:52.000 --> 00:39:55.000 emerging threats, OCET however 00:39:55.000 --> 00:39:57.000 as of October 1st our program is 00:39:57.000 --> 00:40:02.000 now administered by my new 00:40:02.000 --> 00:40:03.000 office, the office 00:40:03.000 --> 00:40:04.000 Office of Regulatory and 00:40:04.000 --> 00:40:09.000 Emerging Science. We're still 00:40:09.000 --> 00:40:11.000 working out how to pronounce 00:40:11.000 --> 00:40:13.000 the acronyms involved. But 00:40:13.000 --> 00:40:16.000 we'll keep everyone posted on 00:40:16.000 --> 00:40:20.000 that. The MCMi scope is really 00:40:20.000 --> 00:40:22.000 really unchanged we're defining 00:40:22.000 --> 00:40:25.000 that as we proceed. We'll get 00:40:25.000 --> 00:40:27.000 into that a bit more when we 00:40:27.000 --> 00:40:30.000 delve into the BAA itself. 00:40:30.000 --> 00:40:31.000 Next slide, please. So we need 00:40:31.000 --> 00:40:35.000 to define medical counter 00:40:35.000 --> 00:40:39.000 measures in the context of the 00:40:39.000 --> 00:40:41.000 FDA mission space and the FDA 00:40:41.000 --> 00:40:44.000 BAA in this case when we discuss 00:40:44.000 --> 00:40:48.000 medical counter measures are 00:40:48.000 --> 00:40:53.000 FDA-regulated product that are 00:40:53.000 --> 00:40:56.000 dined to protect against 00:40:56.000 --> 00:40:58.000 diseases caused by agents. One 00:40:58.000 --> 00:41:01.000 thing I should mention generally 00:41:01.000 --> 00:41:04.000 when it comes to strategy the 00:41:04.000 --> 00:41:08.000 idea is mitigation, either 00:41:08.000 --> 00:41:10.000 mitigating the impacts of 00:41:10.000 --> 00:41:14.000 an event or preventing or 00:41:14.000 --> 00:41:17.000 treating. In terms of examples 00:41:17.000 --> 00:41:19.000 of products, what comes to mind 00:41:19.000 --> 00:41:22.000 is vaccines. But anything that 00:41:22.000 --> 00:41:24.000 that is involved in a response 00:41:24.000 --> 00:41:25.000 effort including PPE as well as 00:41:25.000 --> 00:41:28.000 diagnostic tests and other kinds 00:41:28.000 --> 00:41:29.000 of treatment could be codified 00:41:29.000 --> 00:41:30.000 as medical counter measures ask 00:41:30.000 --> 00:41:31.000 all of that is kind of 00:41:31.000 --> 00:41:33.000 represented in our portfolio. 00:41:33.000 --> 00:41:36.000 Next slide, please. 00:41:36.000 --> 00:41:39.000 So speaking of that portfolio 00:41:39.000 --> 00:41:40.000 what is the goal of the MCMi 00:41:40.000 --> 00:41:45.000 regulatory science program in 00:41:45.000 --> 00:41:47.000 this context? Well our sport 00:41:47.000 --> 00:41:51.000 is developing tool and 00:41:51.000 --> 00:41:52.000 approaches for quality and 00:41:52.000 --> 00:41:54.000 performance. That's where you 00:41:54.000 --> 00:41:57.000 see sort of the interface of our 00:41:57.000 --> 00:41:59.000 office with the overall FDA 00:41:59.000 --> 00:42:01.000 mission space of testing the 00:42:01.000 --> 00:42:02.000 safety and efficacy of medical 00:42:02.000 --> 00:42:05.000 products. In our case, it's not 00:42:05.000 --> 00:42:06.000 so much question of product 00:42:06.000 --> 00:42:08.000 development. It's more along 00:42:08.000 --> 00:42:10.000 the lines of, helping to address 00:42:10.000 --> 00:42:12.000 knowledge gaps in the context of 00:42:12.000 --> 00:42:14.000 medical counter measures. That 00:42:14.000 --> 00:42:15.000 may prevent us from being able 00:42:15.000 --> 00:42:18.000 to assess effectively that -- 00:42:18.000 --> 00:42:21.000 that safety and efficacy factor. 00:42:21.000 --> 00:42:22.000 This is particularly difficult 00:42:22.000 --> 00:42:24.000 in the context of medical 00:42:24.000 --> 00:42:27.000 counter measures given reliance 00:42:27.000 --> 00:42:29.000 on the animal rule for an 00:42:29.000 --> 00:42:34.000 approach for evaluation and 00:42:34.000 --> 00:42:36.000 license sure. We will get into 00:42:36.000 --> 00:42:38.000 the specifics of that as well. 00:42:38.000 --> 00:42:43.000 . What this really means is 00:42:43.000 --> 00:42:44.000 that we e effect FIFly are a 00:42:44.000 --> 00:42:45.000 program management offices that 00:42:45.000 --> 00:42:46.000 ffectively are a program 00:42:46.000 --> 00:42:48.000 management offices that uses a 00:42:48.000 --> 00:42:51.000 series of activity such as extra 00:42:51.000 --> 00:42:53.000 mural research as well as 00:42:53.000 --> 00:42:54.000 intramural research and internal 00:42:54.000 --> 00:42:57.000 funding. These are -- when I 00:42:57.000 --> 00:42:59.000 when I say intermural research 00:42:59.000 --> 00:43:01.000 this is the opportunities to 00:43:01.000 --> 00:43:03.000 fund FDA performers to carry out 00:43:03.000 --> 00:43:05.000 research activities. And 00:43:05.000 --> 00:43:07.000 really, this is more of an -- 00:43:07.000 --> 00:43:09.000 internal funding transfer to 00:43:09.000 --> 00:43:10.000 facilitate those particular 00:43:10.000 --> 00:43:11.000 projects. 00:43:11.000 --> 00:43:12.000 We also have extensive 00:43:12.000 --> 00:43:16.000 collaboration and coordination 00:43:16.000 --> 00:43:18.000 with other government agencies. 00:43:18.000 --> 00:43:21.000 And this takes -- this takes 00:43:21.000 --> 00:43:23.000 place in part due to our use of 00:43:23.000 --> 00:43:24.000 interagency agreements. And 00:43:24.000 --> 00:43:25.000 we're going to need to touch on 00:43:25.000 --> 00:43:29.000 on interagency agreements again 00:43:29.000 --> 00:43:30.000 again and we'll do that 00:43:30.000 --> 00:43:32.000 shortly. Next slide, please. 00:43:32.000 --> 00:43:33.000 So going into the BAA contracts 00:43:33.000 --> 00:43:35.000 themselves that apply office 00:43:35.000 --> 00:43:36.000 supports, I can speak based on 00:43:36.000 --> 00:43:40.000 the -- the history of the 00:43:40.000 --> 00:43:41.000 portfolio. And come to some 00:43:41.000 --> 00:43:43.000 general structures here. BAA 00:43:43.000 --> 00:43:44.000 contracts are typically 00:43:44.000 --> 00:43:47.000 structured with a base period of 00:43:47.000 --> 00:43:48.000 of performance and note that I 00:43:48.000 --> 00:43:50.000 said base period not base year 00:43:50.000 --> 00:43:52.000 we have a base period typically 00:43:52.000 --> 00:43:53.000 anywhere from one to three years 00:43:53.000 --> 00:43:55.000 with a variable number of option 00:43:55.000 --> 00:43:56.000 and is it really depends on the 00:43:56.000 --> 00:43:57.000 nature and the technical 00:43:57.000 --> 00:43:58.000 approach for the different kinds 00:43:58.000 --> 00:44:00.000 of research that we're 00:44:00.000 --> 00:44:02.000 supporting. 00:44:02.000 --> 00:44:03.000 But the overall period of 00:44:03.000 --> 00:44:06.000 performance doesn't exceed five 00:44:06.000 --> 00:44:09.000 years. And I say this because I 00:44:09.000 --> 00:44:13.000 really advise -- would-be 00:44:13.000 --> 00:44:14.000 PECHLers to structure proposals 00:44:14.000 --> 00:44:16.000 accord look e if you have an 00:44:16.000 --> 00:44:17.000 performers to structure 00:44:17.000 --> 00:44:18.000 proposals accord look e if you 00:44:18.000 --> 00:44:19.000 have an opportunity to present a 00:44:19.000 --> 00:44:20.000 product in the form of a base 00:44:20.000 --> 00:44:25.000 period proof of concept with 00:44:25.000 --> 00:44:26.000 additional options tacked on to 00:44:26.000 --> 00:44:28.000 delve further or leverage that 00:44:28.000 --> 00:44:29.000 proof of concept that M might be 00:44:29.000 --> 00:44:30.000 something that better aligns 00:44:30.000 --> 00:44:32.000 with the kind of research that 00:44:32.000 --> 00:44:34.000 we support. In terms of 00:44:34.000 --> 00:44:38.000 management it is actually 00:44:38.000 --> 00:44:41.000 conducted by folks on my team. 00:44:41.000 --> 00:44:42.000 They have disciplines in 00:44:42.000 --> 00:44:44.000 biological and other sciences as 00:44:44.000 --> 00:44:45.000 as well as the training to be a 00:44:45.000 --> 00:44:46.000 contract officer representatives 00:44:46.000 --> 00:44:49.000 there's a team of actually five 00:44:49.000 --> 00:44:51.000 of us. And we sometimes work in 00:44:51.000 --> 00:44:52.000 tandem in supporting these 00:44:52.000 --> 00:44:53.000 different projects. 00:44:53.000 --> 00:44:55.000 In terms of reporting and 00:44:55.000 --> 00:44:57.000 communication, we use either 00:44:57.000 --> 00:45:00.000 monthly or bimonthly meetings 00:45:00.000 --> 00:45:01.000 for check ins with ad hoc 00:45:01.000 --> 00:45:04.000 meetings as necessary and either 00:45:04.000 --> 00:45:06.000 monthly or quarterly progress 00:45:06.000 --> 00:45:07.000 reports. NEGZ slide, please. 00:45:07.000 --> 00:45:08.000 ext slide, please. 00:45:08.000 --> 00:45:09.000 Going further into the nature of 00:45:09.000 --> 00:45:12.000 our work our contracts are 00:45:12.000 --> 00:45:14.000 considered high-complexity as 00:45:14.000 --> 00:45:15.000 defined in the contractor 00:45:15.000 --> 00:45:19.000 performance assessment rating 00:45:19.000 --> 00:45:21.000 system or CPARS and 00:45:21.000 --> 00:45:22.000 historically, we typically use 00:45:22.000 --> 00:45:24.000 contract reimbursement but I am 00:45:24.000 --> 00:45:28.000 not a contract office Rer and I 00:45:28.000 --> 00:45:29.000 I wouldn't dare to be one so we 00:45:29.000 --> 00:45:31.000 would defer to the statute in 00:45:31.000 --> 00:45:32.000 in terms of the contract type. 00:45:32.000 --> 00:45:34.000 I need to touch on this and I am 00:45:34.000 --> 00:45:35.000 probably going to come back to 00:45:35.000 --> 00:45:36.000 this a lot, the concept of what 00:45:36.000 --> 00:45:38.000 is not in scope of the contracts 00:45:38.000 --> 00:45:40.000 that we support or pursue? And 00:45:40.000 --> 00:45:42.000 what we don't do is PRUBLT 00:45:42.000 --> 00:45:44.000 development or postmarketing 00:45:44.000 --> 00:45:46.000 market surveillance. For 00:45:46.000 --> 00:45:47.000 product development or 00:45:47.000 --> 00:45:48.000 postmarketing market 00:45:48.000 --> 00:45:49.000 surveillance. For specific 00:45:49.000 --> 00:45:50.000 products. Our research at the 00:45:50.000 --> 00:45:52.000 at the end. Of the day is 00:45:52.000 --> 00:45:55.000 really intended to be product 00:45:55.000 --> 00:45:57.000 ago NOISic. Address knowledge 00:45:57.000 --> 00:45:59.000 gaps that are in our particular 00:45:59.000 --> 00:46:00.000 mission space here at FDA so as 00:46:00.000 --> 00:46:03.000 a result that is something that 00:46:03.000 --> 00:46:04.000 nostic. Address knowledge gaps 00:46:04.000 --> 00:46:05.000 that are in our particular mission space here at FDA so as 00:46:05.000 --> 00:46:06.000 a result that is something that 00:46:06.000 --> 00:46:07.000 has been a bit of a tougher 00:46:07.000 --> 00:46:08.000 target from a BAA SPESHGT but 00:46:08.000 --> 00:46:10.000 it's something that a little 00:46:10.000 --> 00:46:12.000 additional consideration and 00:46:12.000 --> 00:46:13.000 thought it is an achievable goal 00:46:13.000 --> 00:46:15.000 . 00:46:15.000 --> 00:46:16.000 perspective but it's something 00:46:16.000 --> 00:46:17.000 that a little additional 00:46:17.000 --> 00:46:18.000 consideration and thought it is 00:46:18.000 --> 00:46:19.000 an achievable goal. 00:46:19.000 --> 00:46:20.000 One other thing I should mention 00:46:20.000 --> 00:46:22.000 here with regard to our general 00:46:22.000 --> 00:46:24.000 accounts we e we often cofund 00:46:24.000 --> 00:46:27.000 with other agencies. I 00:46:27.000 --> 00:46:30.000 mentioned interagencies. That's 00:46:30.000 --> 00:46:32.000 where this comes in. For those 00:46:32.000 --> 00:46:33.000 that would be potentially 00:46:33.000 --> 00:46:34.000 applying one thing to consider 00:46:34.000 --> 00:46:36.000 is that when we do have 00:46:36.000 --> 00:46:39.000 collaboration of this kind with 00:46:39.000 --> 00:46:42.000 other agencies it may extend the 00:46:42.000 --> 00:46:45.000 away final frame because we need 00:46:45.000 --> 00:46:47.000 to get those interagencies in 00:46:47.000 --> 00:46:50.000 place if the research is indeed 00:46:50.000 --> 00:46:55.000 collaborative and using parable 00:46:55.000 --> 00:46:57.000 partial funding. These are 00:46:57.000 --> 00:46:58.000 typically knowledge products we 00:46:58.000 --> 00:47:01.000 we don't typically get into 00:47:01.000 --> 00:47:03.000 prototypes. But what we do like 00:47:03.000 --> 00:47:05.000 to see from our projects are 00:47:05.000 --> 00:47:06.000 technical reports especially 00:47:06.000 --> 00:47:09.000 things that are suitable for 00:47:09.000 --> 00:47:11.000 influencing FDA guidance data 00:47:11.000 --> 00:47:14.000 summaries collections and data 00:47:14.000 --> 00:47:15.000 data bases that's 00:47:15.000 --> 00:47:17.000 public-available data bases 00:47:17.000 --> 00:47:18.000 ideally. We don't have 00:47:18.000 --> 00:47:20.000 publications as a set 00:47:20.000 --> 00:47:22.000 deliverable because of the peer 00:47:22.000 --> 00:47:23.000 review process but we do 00:47:23.000 --> 00:47:26.000 encourage publications and 00:47:26.000 --> 00:47:29.000 presentations to enhance the 00:47:29.000 --> 00:47:31.000 impact of the research in the 00:47:31.000 --> 00:47:33.000 broader community. Next slide, 00:47:33.000 --> 00:47:35.000 please. 00:47:35.000 --> 00:47:37.000 So we can get into the contract 00:47:37.000 --> 00:47:43.000 areas here. And what I'll say 00:47:43.000 --> 00:47:47.000 is that our area of interest is 00:47:47.000 --> 00:47:50.000 in charge III part A which 00:47:50.000 --> 00:47:52.000 pertains to KROURNT measures. 00:47:52.000 --> 00:47:53.000 counter measures. We have have 00:47:53.000 --> 00:47:56.000 the four major primary research 00:47:56.000 --> 00:48:01.000 areas listed here but we will go 00:48:01.000 --> 00:48:02.000 into them VINLly. So the first 00:48:02.000 --> 00:48:03.000 individually. So the first is 00:48:03.000 --> 00:48:05.000 to develop and characterize 00:48:05.000 --> 00:48:08.000 tools to support and KWOP this 00:48:08.000 --> 00:48:09.000 might be a little redundant. 00:48:09.000 --> 00:48:10.000 But it is one of the primary 00:48:10.000 --> 00:48:12.000 ones that we pursued over the 00:48:12.000 --> 00:48:14.000 history of the program. This 00:48:14.000 --> 00:48:15.000 includes alternative methods to 00:48:15.000 --> 00:48:18.000 animaltist testing and 00:48:18.000 --> 00:48:23.000 alternative models to tradition 00:48:23.000 --> 00:48:27.000 to traditional 00:48:27.000 --> 00:48:32.000 animal models potentially 00:48:32.000 --> 00:48:34.000 alternative models 00:48:34.000 --> 00:48:35.000 to pry MAEM mattes one of the 00:48:35.000 --> 00:48:39.000 things that did emerge from the 00:48:39.000 --> 00:48:41.000 COVID, the potential of... 00:48:41.000 --> 00:48:44.000 nonhuman pry ma'am mattes and 00:48:44.000 --> 00:48:47.000 as a result two of our most 00:48:47.000 --> 00:48:49.000 recent awards are currently sass 00:48:49.000 --> 00:48:52.000 certaining the viability of 00:48:52.000 --> 00:48:54.000 models. However I should also 00:48:54.000 --> 00:49:01.000 point out that this also has a 00:49:01.000 --> 00:49:05.000 a strong emphasis on... 00:49:05.000 --> 00:49:06.000 organs for specific use case 00:49:06.000 --> 00:49:08.000 ins KROURNT measure development 00:49:08.000 --> 00:49:10.000 this is something also that has 00:49:10.000 --> 00:49:11.000 been supported under the 00:49:11.000 --> 00:49:12.000 counter measure development this 00:49:12.000 --> 00:49:13.000 is something also that has been 00:49:13.000 --> 00:49:14.000 supported under the portfolio 00:49:14.000 --> 00:49:17.000 for both recently and actually 00:49:17.000 --> 00:49:18.000 historically. We also under 00:49:18.000 --> 00:49:21.000 this particular paradigm, we 00:49:21.000 --> 00:49:24.000 also conduct applied research 00:49:24.000 --> 00:49:26.000 that may actually tend a bit 00:49:26.000 --> 00:49:28.000 more towards basic. And I say 00:49:28.000 --> 00:49:31.000 that because we're really 00:49:31.000 --> 00:49:32.000 looking at HOS pathogen 00:49:32.000 --> 00:49:34.000 interaction and elements of that 00:49:34.000 --> 00:49:35.000 nature such as disease 00:49:35.000 --> 00:49:37.000 progression, disease history but 00:49:37.000 --> 00:49:40.000 also looking at biomarkers or 00:49:40.000 --> 00:49:42.000 trying to establish biomarkers 00:49:42.000 --> 00:49:43.000 and correlates of protection 00:49:43.000 --> 00:49:46.000 this however is really done 00:49:46.000 --> 00:49:47.000 done again under the applied 00:49:47.000 --> 00:49:50.000 mission space of counter measure 00:49:50.000 --> 00:49:51.000 evaluation. And it is something 00:49:51.000 --> 00:49:53.000 that if you look at the history 00:49:53.000 --> 00:49:54.000 of the portfolio we've 00:49:54.000 --> 00:49:56.000 supported we've also supported 00:49:56.000 --> 00:49:58.000 novel methods to assess these 00:49:58.000 --> 00:50:01.000 kinds of things. 00:50:01.000 --> 00:50:02.000 Finally I did want to touch on 00:50:02.000 --> 00:50:04.000 the concept of bridging data and 00:50:04.000 --> 00:50:06.000 this is the idea of being able 00:50:06.000 --> 00:50:08.000 to bridge data between animal 00:50:08.000 --> 00:50:09.000 models and clinical models. The 00:50:09.000 --> 00:50:13.000 best example I can give is our 00:50:13.000 --> 00:50:15.000 most recent organ ship contract 00:50:15.000 --> 00:50:20.000 included the development of both 00:50:20.000 --> 00:50:22.000 nonhuman primate organs 00:50:22.000 --> 00:50:26.000 on CHIFRMs as well as human 00:50:26.000 --> 00:50:28.000 s as well as human-based 00:50:28.000 --> 00:50:30.000 chimps as well as human-based so 00:50:30.000 --> 00:50:31.000 the next one is tied into our 00:50:31.000 --> 00:50:32.000 diagnostic data missions. A lot 00:50:32.000 --> 00:50:36.000 . A lot of the content here 00:50:36.000 --> 00:50:38.000 it's kind of a split paradigm 00:50:38.000 --> 00:50:40.000 with this because a lot of our 00:50:40.000 --> 00:50:43.000 more repeat awards pertain to 00:50:43.000 --> 00:50:44.000 to next generation sequencing 00:50:44.000 --> 00:50:47.000 not necessarily carrying it out 00:50:47.000 --> 00:50:49.000 per se but in some cases 00:50:49.000 --> 00:50:51.000 developing and refining tools to 00:50:51.000 --> 00:50:53.000 better assess quality of 00:50:53.000 --> 00:50:57.000 sequencings that are extracted 00:50:57.000 --> 00:50:59.000 or -- or developed. 00:50:59.000 --> 00:51:02.000 One case that comes to mind or a 00:51:02.000 --> 00:51:06.000 a project that comes to mind is 00:51:06.000 --> 00:51:07.000 our ARGOS two project which is 00:51:07.000 --> 00:51:10.000 seek to go develop the tools to 00:51:10.000 --> 00:51:11.000 identify quote unquote 00:51:11.000 --> 00:51:14.000 regulatory grade genetic 00:51:14.000 --> 00:51:16.000 sequences for use in diagnostics 00:51:16.000 --> 00:51:19.000 in specific disease use cases. 00:51:19.000 --> 00:51:21.000 Historically, we've also pursue 00:51:21.000 --> 00:51:24.000 the the use and inclusion of 00:51:24.000 --> 00:51:27.000 real-world evidence here. So 00:51:27.000 --> 00:51:28.000 this is a bit of a broader brush 00:51:28.000 --> 00:51:30.000 and this is shown in the history 00:51:30.000 --> 00:51:33.000 of the program. So this 00:51:33.000 --> 00:51:36.000 includes the ability to 00:51:36.000 --> 00:51:37.000 preposition protocols for 00:51:37.000 --> 00:51:41.000 real-world evidence for a 00:51:41.000 --> 00:51:43.000 pandemic or epidemic response as 00:51:43.000 --> 00:51:46.000 as well as novel methods of ewe 00:51:46.000 --> 00:51:49.000 utilization of retrospective 00:51:49.000 --> 00:51:50.000 studies using medical claims 00:51:50.000 --> 00:51:51.000 data. 00:51:51.000 --> 00:51:53.000 Next we move into modernizing 00:51:53.000 --> 00:51:56.000 tools to evaluate MCM product 00:51:56.000 --> 00:51:59.000 safety and efficacy. And really 00:51:59.000 --> 00:52:01.000 this is more of a capability 00:52:01.000 --> 00:52:03.000 building element we're looking 00:52:03.000 --> 00:52:06.000 at tools and technologies to 00:52:06.000 --> 00:52:07.000 better address the medical 00:52:07.000 --> 00:52:10.000 counter measure regulatory 00:52:10.000 --> 00:52:11.000 science areas. This is in a 00:52:11.000 --> 00:52:13.000 couple of different sort of 00:52:13.000 --> 00:52:16.000 facets. One is more the 00:52:16.000 --> 00:52:18.000 traditional how can we better 00:52:18.000 --> 00:52:19.000 assess safety and efficacy but 00:52:19.000 --> 00:52:21.000 another element to this is also 00:52:21.000 --> 00:52:24.000 the ability to remain somewhat 00:52:24.000 --> 00:52:27.000 nimble in the face of emerging 00:52:27.000 --> 00:52:28.000 diseases. So in that case in 00:52:28.000 --> 00:52:29.000 the latter case we're really 00:52:29.000 --> 00:52:30.000 talking about agile approaches 00:52:30.000 --> 00:52:32.000 that align to rapid development 00:52:32.000 --> 00:52:34.000 efforts best example I can give 00:52:34.000 --> 00:52:37.000 there is project warp speed in 00:52:37.000 --> 00:52:38.000 support of COVID counter 00:52:38.000 --> 00:52:42.000 measures. 00:52:42.000 --> 00:52:46.000 But we also are seeing e 00:52:46.000 --> 00:52:48.000 emergence of 00:52:48.000 --> 00:52:50.000 a new concept here, that's also 00:52:50.000 --> 00:52:53.000 looking at supply chain resill 00:52:53.000 --> 00:52:54.000 resiliency and manufacturing. 00:52:54.000 --> 00:52:57.000 In this case we're looking at 00:52:57.000 --> 00:53:00.000 different methods to monitor and 00:53:00.000 --> 00:53:03.000 predict disruptions and also 00:53:03.000 --> 00:53:05.000 novel approaches to increase 00:53:05.000 --> 00:53:06.000 ability of supplierers' 00:53:06.000 --> 00:53:08.000 flexibility and ability to 00:53:08.000 --> 00:53:11.000 respond to disruptions as well. 00:53:11.000 --> 00:53:12.000 So resill YEB sea is kind of the 00:53:12.000 --> 00:53:13.000 iency is kind of the key element 00:53:13.000 --> 00:53:15.000 here. Next slide, please. 00:53:15.000 --> 00:53:17.000 This one, advance the 00:53:17.000 --> 00:53:18.000 development of tools to enable 00:53:18.000 --> 00:53:19.000 the rapid development and 00:53:19.000 --> 00:53:22.000 and availability of 00:53:22.000 --> 00:53:24.000 investigational MCMs this one is 00:53:24.000 --> 00:53:27.000 interesting because my office 00:53:27.000 --> 00:53:31.000 while we're very focused on area 00:53:31.000 --> 00:53:32.000 IIIA, we also acknowledge that 00:53:32.000 --> 00:53:33.000 we have colleague colleagues 00:53:33.000 --> 00:53:35.000 that do have mission space here 00:53:35.000 --> 00:53:36.000 as well. And under this 00:53:36.000 --> 00:53:39.000 particular area of interest you 00:53:39.000 --> 00:53:41.000 see sort of a list of different 00:53:41.000 --> 00:53:44.000 kind of elements that may not 00:53:44.000 --> 00:53:47.000 pertain to our office per se but 00:53:47.000 --> 00:53:50.000 does align with MCH-related 00:53:50.000 --> 00:53:51.000 objectives of others A office of 00:53:51.000 --> 00:53:52.000 A office throughout the FDA 00:53:52.000 --> 00:53:54.000 that's why these kind of 00:53:54.000 --> 00:53:56.000 overlap. Some of them are very 00:53:56.000 --> 00:54:00.000 specific. So what I can best 00:54:00.000 --> 00:54:01.000 say about this one is that it's 00:54:01.000 --> 00:54:02.000 helpful to have so to sort of 00:54:02.000 --> 00:54:05.000 capture this is a more 00:54:05.000 --> 00:54:06.000 universal target across the FDA 00:54:06.000 --> 00:54:08.000 the FDA it's really more of an 00:54:08.000 --> 00:54:09.000 an enterprise across the FDA 00:54:09.000 --> 00:54:10.000 but it is something that we do 00:54:10.000 --> 00:54:12.000 we do is a lot of communities 00:54:12.000 --> 00:54:13.000 coming together to address 00:54:13.000 --> 00:54:15.000 medical counter measures. So on 00:54:15.000 --> 00:54:17.000 this one if there are questions 00:54:17.000 --> 00:54:19.000 or if there's -- if you're 00:54:19.000 --> 00:54:21.000 seeking further interface, 00:54:21.000 --> 00:54:23.000 please do not hesitate to reach 00:54:23.000 --> 00:54:25.000 out to me or to the team here 00:54:25.000 --> 00:54:29.000 and I'll provide some contact 00:54:29.000 --> 00:54:33.000 info to -- to have a discussion. 00:54:33.000 --> 00:54:35.000 Next slide, please. 00:54:35.000 --> 00:54:37.000 Okay. So I would be remiss if I 00:54:37.000 --> 00:54:38.000 Deputy bring this up and I know 00:54:38.000 --> 00:54:39.000 we're kind of short on time so 00:54:39.000 --> 00:54:41.000 I'm going to have to go a little 00:54:41.000 --> 00:54:44.000 bit quickly here but our 00:54:44.000 --> 00:54:45.000 advanced manufacturing team now 00:54:45.000 --> 00:54:49.000 the innovative technologies team 00:54:49.000 --> 00:54:51.000 after the reorg they have a 00:54:51.000 --> 00:54:52.000 series of different objectives 00:54:52.000 --> 00:54:55.000 here. And again we get into 00:54:55.000 --> 00:54:56.000 cross cutting and I bring up 00:54:56.000 --> 00:54:58.000 this slide because it does have 00:54:58.000 --> 00:55:01.000 elements that are not 00:55:01.000 --> 00:55:02.000 necessarily solely related to 00:55:02.000 --> 00:55:04.000 to IIIA some some of these are 00:55:04.000 --> 00:55:06.000 actually concepts that are 00:55:06.000 --> 00:55:07.000 dispersed through the BAA I 00:55:07.000 --> 00:55:10.000 bring this up because while we 00:55:10.000 --> 00:55:12.000 have a specific focus on medical 00:55:12.000 --> 00:55:15.000 counter measures and and we sort 00:55:15.000 --> 00:55:17.000 of write that out in IIIA there 00:55:17.000 --> 00:55:20.000 are medical KROURNT measure use 00:55:20.000 --> 00:55:21.000 counter measure use cases that 00:55:21.000 --> 00:55:22.000 we can see and the exploration 00:55:22.000 --> 00:55:24.000 of -- by the innovative 00:55:24.000 --> 00:55:25.000 technologies team through the 00:55:25.000 --> 00:55:27.000 application of advanced 00:55:27.000 --> 00:55:28.000 manufacturing is a really key 00:55:28.000 --> 00:55:31.000 element there. So I get the 00:55:31.000 --> 00:55:32.000 take-home message from this is 00:55:32.000 --> 00:55:35.000 that if there are -- those that 00:55:35.000 --> 00:55:38.000 would submit to the BAA through 00:55:38.000 --> 00:55:40.000 other areas but have medical 00:55:40.000 --> 00:55:41.000 counter measure-relate the use 00:55:41.000 --> 00:55:44.000 cases in mind that is something 00:55:44.000 --> 00:55:45.000 that we would also be -- my team 00:55:45.000 --> 00:55:47.000 would be more than willing to 00:55:47.000 --> 00:55:48.000 take a look at. Next slide, 00:55:48.000 --> 00:55:49.000 please. 00:55:49.000 --> 00:55:50.000 Okay. So the next couple of 00:55:50.000 --> 00:55:51.000 slides we're going to probably 00:55:51.000 --> 00:55:53.000 skip through these pretty 00:55:53.000 --> 00:55:57.000 quickly. So these are just sort 00:55:57.000 --> 00:55:58.000 of historical and on going extra 00:55:58.000 --> 00:56:00.000 mural projects for these you can 00:56:00.000 --> 00:56:02.000 go ahead and skip to the next. 00:56:02.000 --> 00:56:03.000 These are just different 00:56:03.000 --> 00:56:05.000 projects that shall on going 00:56:05.000 --> 00:56:06.000 what I like about projecting 00:56:06.000 --> 00:56:09.000 the slide is even if it's a 00:56:09.000 --> 00:56:10.000 reference that you kind of have 00:56:10.000 --> 00:56:11.000 as a take home these areas 00:56:11.000 --> 00:56:13.000 really do align to specific B 00:56:13.000 --> 00:56:15.000 BAA areas and this Chartier 00:56:15.000 --> 00:56:17.000 sort of shows that. These are 00:56:17.000 --> 00:56:19.000 on going. Next slide. And then 00:56:19.000 --> 00:56:21.000 we have a very robust history of 00:56:21.000 --> 00:56:22.000 completed projects that I wanted 00:56:22.000 --> 00:56:23.000 to include. This list is not 00:56:23.000 --> 00:56:26.000 exhaustive. There are others. 00:56:26.000 --> 00:56:27.000 And not everything we do is 00:56:27.000 --> 00:56:29.000 through the BAA but you can get 00:56:29.000 --> 00:56:31.000 a sense of the dynamics. And 00:56:31.000 --> 00:56:35.000 you'll probably notice that 00:56:35.000 --> 00:56:39.000 right around 2020 we do some 00:56:39.000 --> 00:56:43.000 bends into a specific pandemic 00:56:43.000 --> 00:56:45.000 of interest. Next slide. Our 00:56:45.000 --> 00:56:48.000 Our most project completion was 00:56:48.000 --> 00:56:52.000 actually in March of 2024 and 00:56:52.000 --> 00:56:54.000 that was our latest development 00:56:54.000 --> 00:56:55.000 project. So as we close out 00:56:55.000 --> 00:56:57.000 today I just want to give some 00:56:57.000 --> 00:57:00.000 ideas of metrics and successes 00:57:00.000 --> 00:57:02.000 that are -- our portfolio has 00:57:02.000 --> 00:57:03.000 experienced since 2012, we've 00:57:03.000 --> 00:57:05.000 had a number of different kinds 00:57:05.000 --> 00:57:06.000 of success measured different 00:57:06.000 --> 00:57:09.000 ways. 00:57:09.000 --> 00:57:11.000 We've had 19 contract awards 00:57:11.000 --> 00:57:13.000 including both domestic and 00:57:13.000 --> 00:57:15.000 international performers. We 00:57:15.000 --> 00:57:17.000 have academic industry 00:57:17.000 --> 00:57:20.000 performers. One of the things I 00:57:20.000 --> 00:57:21.000 am most proud of is our 00:57:21.000 --> 00:57:24.000 interagency involvement as well 00:57:24.000 --> 00:57:29.000 as well as intraagency 00:57:29.000 --> 00:57:32.000 involvement we've actually 00:57:32.000 --> 00:57:33.000 collaborated others such as 00:57:33.000 --> 00:57:35.000 such as DETRA as well as NA 00:57:35.000 --> 00:57:38.000 such as DETRA as well as NASA. 00:57:38.000 --> 00:57:41.000 This is some high-level data 00:57:41.000 --> 00:57:42.000 about our contracts and sort of 00:57:42.000 --> 00:57:45.000 financial elements. This is 00:57:45.000 --> 00:57:48.000 another area of success in our N 00:57:48.000 --> 00:57:50.000 in our -- from my perspective 00:57:50.000 --> 00:57:54.000 and what I would point your 00:57:54.000 --> 00:57:56.000 attention to is 22 contract 00:57:56.000 --> 00:58:00.000 modifications I know it's not 00:58:00.000 --> 00:58:02.000 ideal but in our case we've 00:58:02.000 --> 00:58:04.000 encountered situations where 00:58:04.000 --> 00:58:08.000 they are helpful by addressing a 00:58:08.000 --> 00:58:10.000 critical emerging issue. Best 00:58:10.000 --> 00:58:13.000 Best are the different research 00:58:13.000 --> 00:58:14.000 accurates that we had in space 00:58:14.000 --> 00:58:16.000 in 2020 that were initially 00:58:16.000 --> 00:58:18.000 scoped for Ebola as a use case. 00:58:18.000 --> 00:58:21.000 But we realize could have 00:58:21.000 --> 00:58:22.000 extremely high value add if we 00:58:22.000 --> 00:58:24.000 did modifications to pivot 00:58:24.000 --> 00:58:27.000 to pivot those projects to 00:58:27.000 --> 00:58:29.000 to COVID. 00:58:29.000 --> 00:58:30.000 Then finally I do want to end on 00:58:30.000 --> 00:58:31.000 this slide and this is kind of 00:58:31.000 --> 00:58:34.000 our application slide. And this 00:58:34.000 --> 00:58:35.000 And this my intent already to 00:58:35.000 --> 00:58:41.000 to to provide some examples 00:58:41.000 --> 00:58:42.000 that 00:58:42.000 --> 00:58:46.000 you can peruse and this is 00:58:46.000 --> 00:58:47.000 indeed an applied approach and 00:58:47.000 --> 00:58:51.000 our goal for all of the projects 00:58:51.000 --> 00:58:53.000 that we fund under the BAA is to 00:58:53.000 --> 00:58:55.000 advance the ability for FDA to 00:58:55.000 --> 00:58:56.000 provide -- to execute its 00:58:56.000 --> 00:59:00.000 mission, provide guidance and 00:59:00.000 --> 00:59:01.000 ultimately, make available 00:59:01.000 --> 00:59:03.000 medical counter measures for 00:59:03.000 --> 00:59:04.000 both current threats and for 00:59:04.000 --> 00:59:06.000 preparedness and for our 00:59:06.000 --> 00:59:07.000 emerging threats as -- as they 00:59:07.000 --> 00:59:10.000 occur. 00:59:10.000 --> 00:59:13.000 So with that in mind, I will 00:59:13.000 --> 00:59:15.000 stop there. And I'm certainly 00:59:15.000 --> 00:59:19.000 happy to address any questions. 00:59:19.000 --> 00:59:21.000 . I see -- I think there is 00:59:21.000 --> 00:59:22.000 one? 00:59:22.000 --> 00:59:23.000 >>DR. KINNERA CHADA: We have 00:59:23.000 --> 00:59:25.000 We have one question. 00:59:25.000 --> 00:59:29.000 >>DR. ROBERT ORR: Okay. If 00:59:29.000 --> 00:59:32.000 method logical work to improve 00:59:32.000 --> 00:59:36.000 the accuracy and speed of 00:59:36.000 --> 00:59:38.000 vaccine evaluation using methods 00:59:38.000 --> 00:59:39.000 aligned in your priorities? 00:59:39.000 --> 00:59:42.000 Short answer, yes I think that 00:59:42.000 --> 00:59:45.000 that would align. But but it is 00:59:45.000 --> 00:59:49.000 But it is -- there are some 00:59:49.000 --> 00:59:50.000 caveats. And I would highly 00:59:50.000 --> 00:59:52.000 recommend a follow up discussion 00:59:52.000 --> 00:59:56.000 ideally even to that's more 00:59:56.000 --> 00:59:58.000 slated for 2026 concept. The 00:59:58.000 --> 01:00:01.000 reason being is that use case 01:00:01.000 --> 01:00:02.000 does play into our ability to 01:00:02.000 --> 01:00:04.000 prioritize when we have 01:00:04.000 --> 01:00:07.000 submissions to the BA A. What do 01:00:07.000 --> 01:00:09.000 I mean by that? So a few years 01:00:09.000 --> 01:00:12.000 ago, we had a strong 01:00:12.000 --> 01:00:14.000 prioritization for 01:00:14.000 --> 01:00:16.000 COVID-related counter measures 01:00:16.000 --> 01:00:19.000 in that paradigm, we probably 01:00:19.000 --> 01:00:21.000 would've had to deprioritize 01:00:21.000 --> 01:00:23.000 other -- other threat ANLTS 01:00:23.000 --> 01:00:24.000 threat agents or other threat 01:00:24.000 --> 01:00:26.000 agents use cases. So it's 01:00:26.000 --> 01:00:30.000 something that I would say, yes, 01:00:30.000 --> 01:00:33.000 it would be aligned but it's 01:00:33.000 --> 01:00:34.000 something that I would certainly 01:00:34.000 --> 01:00:36.000 encourage pre-submission 01:00:36.000 --> 01:00:38.000 discussion just to make sure 01:00:38.000 --> 01:00:39.000 that it's aligned with kind of 01:00:39.000 --> 01:00:44.000 our current threat paradigm 01:00:44.000 --> 01:00:46.000 which does play a factor. 01:00:46.000 --> 01:00:47.000 Anything else? 01:00:47.000 --> 01:00:50.000 >>DR. KINNERA CHADA: Thank you, 01:00:50.000 --> 01:00:51.000 Dr. Orr. 01:00:51.000 --> 01:00:52.000 >>DR. ROBERT ORR: Thank you so 01:00:52.000 --> 01:00:53.000 much if you have additional 01:00:53.000 --> 01:00:55.000 questions I am happy to address. 01:00:55.000 --> 01:00:58.000 I'm going to do one last thing 01:00:58.000 --> 01:01:02.000 I promise and that is to put our 01:01:02.000 --> 01:01:06.000 -- our extra mural web page here 01:01:06.000 --> 01:01:07.000 for those to per reduce. I 01:01:07.000 --> 01:01:09.000 mentioned a lot of different 01:01:09.000 --> 01:01:11.000 products today you can find 01:01:11.000 --> 01:01:13.000 information about all of them 01:01:13.000 --> 01:01:14.000 there. And thank you so much. 01:01:14.000 --> 01:01:16.000 >>DR. KINNERA CHADA: Thank you 01:01:16.000 --> 01:01:19.000 our next presentation is from 01:01:19.000 --> 01:01:21.000 Dr. Rebekah Zinn. She would be 01:01:21.000 --> 01:01:23.000 presented oncology research 01:01:23.000 --> 01:01:24.000 priorities. 01:01:24.000 --> 01:01:27.000 >>DR. REBEKAH ZINN: Good 01:01:27.000 --> 01:01:29.000 afternoon. I am Rebekah Zinn an 01:01:29.000 --> 01:01:33.000 adviser for research strategy 01:01:33.000 --> 01:01:34.000 and external partnerships 01:01:34.000 --> 01:01:38.000 Oncology Center of Excellence. 01:01:38.000 --> 01:01:40.000 I will be providing an 01:01:40.000 --> 01:01:42.000 introduction and overview, 01:01:42.000 --> 01:01:43.000 explain our interest and 01:01:43.000 --> 01:01:45.000 participation in the BAA 01:01:45.000 --> 01:01:47.000 program, and briefly introduce 01:01:47.000 --> 01:01:51.000 our scientific priorities. The 01:01:51.000 --> 01:01:52.000 OCE was -- next slide, please. 01:01:52.000 --> 01:01:54.000 The Oncology Center of 01:01:54.000 --> 01:01:57.000 The OCE was established in 2017 01:01:57.000 --> 01:01:59.000 under the 21st century cares act 01:01:59.000 --> 01:02:01.000 our mission is to achieve 01:02:01.000 --> 01:02:03.000 patient-centered regulatory 01:02:03.000 --> 01:02:04.000 decision-making. We're 01:02:04.000 --> 01:02:07.000 responsible for clinical review 01:02:07.000 --> 01:02:09.000 of oncology therapeutics and we 01:02:09.000 --> 01:02:10.000 work across FDA centers that are 01:02:10.000 --> 01:02:12.000 active in product development 01:02:12.000 --> 01:02:17.000 such as the center for 01:02:17.000 --> 01:02:19.000 biologics which regulates 01:02:19.000 --> 01:02:24.000 cart T and therapeutic 01:02:24.000 --> 01:02:26.000 vaccines. 01:02:26.000 --> 01:02:28.000 The center for drugs such as 01:02:28.000 --> 01:02:31.000 monoclonal antibodies and the 01:02:31.000 --> 01:02:33.000 center for device and is ready 01:02:33.000 --> 01:02:35.000 logical health that REL 01:02:35.000 --> 01:02:37.000 regulates not only therapeutic 01:02:37.000 --> 01:02:41.000 devices and and oncology but 01:02:41.000 --> 01:02:43.000 also invitro diagnostics that 01:02:43.000 --> 01:02:45.000 are important in precision 01:02:45.000 --> 01:02:47.000 oncology. Next slide, please. 01:02:47.000 --> 01:02:50.000 Regulatory review of oncology 01:02:50.000 --> 01:02:52.000 therapeutics is at the core of 01:02:52.000 --> 01:02:54.000 OCE's work but as shown on this 01:02:54.000 --> 01:02:56.000 slide we also have programs in 01:02:56.000 --> 01:02:59.000 other areas including regulatory 01:02:59.000 --> 01:03:02.000 science, education, stake holder 01:03:02.000 --> 01:03:03.000 ENL GAENLment and regulatory 01:03:03.000 --> 01:03:07.000 engagement and regulatory policy 01:03:07.000 --> 01:03:08.000 our participation is part of our 01:03:08.000 --> 01:03:12.000 work in regulatory science. 01:03:12.000 --> 01:03:14.000 Next slide, please. 01:03:14.000 --> 01:03:16.000 FDA oncology staff are very 01:03:16.000 --> 01:03:18.000 active in scientific actives 01:03:18.000 --> 01:03:22.000 including publishing apparent 01:03:22.000 --> 01:03:24.000 papers. And they are 01:03:24.000 --> 01:03:25.000 interested in collaborating. 01:03:25.000 --> 01:03:27.000 OCE did an analysis of 01:03:27.000 --> 01:03:29.000 publications produce bid 01:03:29.000 --> 01:03:30.000 oncology staff at FDA and 01:03:30.000 --> 01:03:33.000 learned that as a group they 01:03:33.000 --> 01:03:35.000 published between 75 and 100 01:03:35.000 --> 01:03:36.000 articles per year. About 20 01:03:36.000 --> 01:03:38.000 percent of these are summaries 01:03:38.000 --> 01:03:42.000 of regulatory approvals. But 01:03:42.000 --> 01:03:43.000 many of the remaining papers 01:03:43.000 --> 01:03:47.000 focused on research. In general 01:03:47.000 --> 01:03:48.000 these papers are very impactful. 01:03:48.000 --> 01:03:51.000 These analysis showed that 01:03:51.000 --> 01:03:55.000 these papers are cited about two 01:03:55.000 --> 01:03:57.000 two times more frequently than 01:03:57.000 --> 01:04:01.000 an NIH funded application. At 01:04:01.000 --> 01:04:02.000 At the OCE, I support the 01:04:02.000 --> 01:04:06.000 scientific collaborative which 01:04:06.000 --> 01:04:08.000 is led by Dr. Julie snider. The 01:04:08.000 --> 01:04:12.000 goal so to support staff to plan 01:04:12.000 --> 01:04:13.000 and conduct high-quality 01:04:13.000 --> 01:04:15.000 research that addresses 01:04:15.000 --> 01:04:17.000 challenges identified during 01:04:17.000 --> 01:04:18.000 regulatory review of oncology 01:04:18.000 --> 01:04:20.000 therapeutics. More information 01:04:20.000 --> 01:04:24.000 about the collaborative can be 01:04:24.000 --> 01:04:34.000 can be found on our website 01:04:34.000 --> 01:04:36.000 on FDA.gov. And the regulatory 01:04:36.000 --> 01:04:38.000 review process. Such as 01:04:38.000 --> 01:04:39.000 informing benefit/risk 01:04:39.000 --> 01:04:40.000 assessment rather than 01:04:40.000 --> 01:04:42.000 increasing general knowledge 01:04:42.000 --> 01:04:46.000 about cancer which is more 01:04:46.000 --> 01:04:47.000 relevant to NIH or NCI next 01:04:47.000 --> 01:04:50.000 slide, please. 01:04:50.000 --> 01:04:52.000 In 2021, OCE performed an 01:04:52.000 --> 01:04:54.000 analysis of scientific 01:04:54.000 --> 01:04:56.000 activities including 01:04:56.000 --> 01:04:57.000 publications internal research 01:04:57.000 --> 01:04:59.000 projects, research 01:04:59.000 --> 01:05:00.000 collaborations can external 01:05:00.000 --> 01:05:02.000 institutions, meetings and work 01:05:02.000 --> 01:05:05.000 workshops through this 01:05:05.000 --> 01:05:08.000 analysis, Dr. Snider and 01:05:08.000 --> 01:05:10.000 colleagues identified areas that 01:05:10.000 --> 01:05:11.000 OCE is active in and this 01:05:11.000 --> 01:05:14.000 informed the development of the 01:05:14.000 --> 01:05:16.000 nine scientific areas and one 01:05:16.000 --> 01:05:17.000 cross cutting area. More 01:05:17.000 --> 01:05:19.000 details can be found FTD 01:05:19.000 --> 01:05:22.000 publication REFRNTSed on this 01:05:22.000 --> 01:05:24.000 referenced on this slide and 01:05:24.000 --> 01:05:26.000 OCE's interest areas are in the 01:05:26.000 --> 01:05:27.000 table. I would like to clarify 01:05:27.000 --> 01:05:29.000 these are not the only areas 01:05:29.000 --> 01:05:31.000 thatter with interested in and 01:05:31.000 --> 01:05:32.000 can evolve over time. During 01:05:32.000 --> 01:05:33.000 the next part of my talk I am 01:05:33.000 --> 01:05:36.000 going to briefly introduce each 01:05:36.000 --> 01:05:40.000 of our sign tiffic areas all of 01:05:40.000 --> 01:05:41.000 this information can be found 01:05:41.000 --> 01:05:44.000 on the BAA announcement and the 01:05:44.000 --> 01:05:47.000 the scientific interest area 01:05:47.000 --> 01:05:50.000 website. We mapped the 01:05:50.000 --> 01:05:52.000 subtopics to the BAA areas on 01:05:52.000 --> 01:05:53.000 this website. Several of our 01:05:53.000 --> 01:05:55.000 interest areas have added new 01:05:55.000 --> 01:05:56.000 topics of interest this year 01:05:56.000 --> 01:05:59.000 which I will mention in my 01:05:59.000 --> 01:06:03.000 slides. Next slide, please. 01:06:03.000 --> 01:06:04.000 In the area of cell and gene 01:06:04.000 --> 01:06:06.000 therapies we are interested in 01:06:06.000 --> 01:06:08.000 applies research projects 01:06:08.000 --> 01:06:09.000 research related to clinical 01:06:09.000 --> 01:06:10.000 development, safety evaluation 01:06:10.000 --> 01:06:13.000 manufacturing and quality 01:06:13.000 --> 01:06:15.000 control and approaches such as 01:06:15.000 --> 01:06:18.000 gene editing-based technology, 01:06:18.000 --> 01:06:20.000 cell therapy and neoantigen 01:06:20.000 --> 01:06:24.000 based cancer therapy. Next 01:06:24.000 --> 01:06:25.000 Next slide please. Very 01:06:25.000 --> 01:06:27.000 interested in understanding 01:06:27.000 --> 01:06:29.000 factors that affect safety and 01:06:29.000 --> 01:06:30.000 treatment response in 01:06:30.000 --> 01:06:32.000 demographic subgroup that have 01:06:32.000 --> 01:06:33.000 been historically 01:06:33.000 --> 01:06:36.000 underrepresented in oncology 01:06:36.000 --> 01:06:38.000 trials. Such as racial and 01:06:38.000 --> 01:06:40.000 ethnic minorities, older adults 01:06:40.000 --> 01:06:41.000 and persons with disabilities to 01:06:41.000 --> 01:06:43.000 name a few. 01:06:43.000 --> 01:06:45.000 And a new topic in this area 01:06:45.000 --> 01:06:50.000 this year is to study real-world 01:06:50.000 --> 01:06:51.000 world data to understand drug 01:06:51.000 --> 01:06:55.000 ewe till education and dozing 01:06:55.000 --> 01:06:57.000 patterns for oral therapies 01:06:57.000 --> 01:06:59.000 in adults with cancer. 01:06:59.000 --> 01:07:01.000 We're trying to support applied 01:07:01.000 --> 01:07:04.000 research to analyze clinical and 01:07:04.000 --> 01:07:05.000 sign TICHic issues relevant to 01:07:05.000 --> 01:07:08.000 regulatory submissions of immune 01:07:08.000 --> 01:07:09.000 cientific issues relevant to 01:07:09.000 --> 01:07:10.000 regulatory submissions of immune 01:07:10.000 --> 01:07:11.000 oncology products such as 01:07:11.000 --> 01:07:13.000 understanding unique side 01:07:13.000 --> 01:07:14.000 effects and atypical responses 01:07:14.000 --> 01:07:18.000 to immune check point 01:07:18.000 --> 01:07:21.000 inhibitors. Next slide. 01:07:21.000 --> 01:07:23.000 We have a very active research 01:07:23.000 --> 01:07:24.000 program in the oncology patient 01:07:24.000 --> 01:07:26.000 focused drug development we are 01:07:26.000 --> 01:07:28.000 interested to support applied 01:07:28.000 --> 01:07:31.000 research to promote use of 01:07:31.000 --> 01:07:32.000 clinical outcome measures to 01:07:32.000 --> 01:07:36.000 quantify symptoms and function 01:07:36.000 --> 01:07:38.000 in oncology trial and is also 01:07:38.000 --> 01:07:41.000 to develop create standard 01:07:41.000 --> 01:07:42.000 clinical end points, analytic 01:07:42.000 --> 01:07:44.000 visualization methods and use of 01:07:44.000 --> 01:07:45.000 digital health tech THOLG to 01:07:45.000 --> 01:07:46.000 further characterize a product's 01:07:46.000 --> 01:07:48.000 nology to further characterize a 01:07:48.000 --> 01:07:49.000 product's safety and efficacy. 01:07:49.000 --> 01:07:54.000 Next slide. 01:07:54.000 --> 01:07:57.000 In the area of 01:07:57.000 --> 01:07:59.000 of methods, we are interested 01:07:59.000 --> 01:08:01.000 in statistical analyses of 01:08:01.000 --> 01:08:02.000 trial designs we are also 01:08:02.000 --> 01:08:04.000 interested in research to 01:08:04.000 --> 01:08:05.000 identify, develop or refine end 01:08:05.000 --> 01:08:07.000 points using data sources other 01:08:07.000 --> 01:08:10.000 than information collected 01:08:10.000 --> 01:08:13.000 during traditional clinical 01:08:13.000 --> 01:08:15.000 trials that could be used in 01:08:15.000 --> 01:08:17.000 clinical studies during 01:08:17.000 --> 01:08:19.000 regulatory submissions. And new 01:08:19.000 --> 01:08:23.000 to this area this year is to a 01:08:23.000 --> 01:08:27.000 topic to evaluate statistical 01:08:27.000 --> 01:08:29.000 methods events in oncology 01:08:29.000 --> 01:08:30.000 clinical TRIELS including but 01:08:30.000 --> 01:08:32.000 not limited to cross over 01:08:32.000 --> 01:08:33.000 trials including but not limited 01:08:33.000 --> 01:08:34.000 to cross over treatment switch, 01:08:34.000 --> 01:08:35.000 treatment discontinuation or 01:08:35.000 --> 01:08:38.000 other events that could inform 01:08:38.000 --> 01:08:39.000 sensory. 01:08:39.000 --> 01:08:40.000 In the area of oncology 01:08:40.000 --> 01:08:41.000 therapeutic SHAERP we are 01:08:41.000 --> 01:08:43.000 therapy we are interested in new 01:08:43.000 --> 01:08:45.000 approaches for consistent and 01:08:45.000 --> 01:08:47.000 rigorous analysis of safety 01:08:47.000 --> 01:08:49.000 signals throughout the life 01:08:49.000 --> 01:08:54.000 cycle of oncology therapeutic 01:08:54.000 --> 01:08:56.000 s and to improve toxicity of 01:08:56.000 --> 01:08:57.000 the populations. We are also 01:08:57.000 --> 01:09:00.000 interested in exploring use of 01:09:00.000 --> 01:09:02.000 REL-world data to inform 01:09:02.000 --> 01:09:03.000 real-world data to inform 01:09:03.000 --> 01:09:05.000 post-market safety and new this 01:09:05.000 --> 01:09:08.000 year to this area is a topic to 01:09:08.000 --> 01:09:10.000 develop improved and STASHGTized 01:09:10.000 --> 01:09:17.000 approaches to collect serious 01:09:17.000 --> 01:09:20.000 toxicities such as bispecific T 01:09:20.000 --> 01:09:21.000 cell. Next slide, please. 01:09:21.000 --> 01:09:24.000 We are also interested in 01:09:24.000 --> 01:09:25.000 applied research to accelerate 01:09:25.000 --> 01:09:27.000 the development of oncology 01:09:27.000 --> 01:09:31.000 therapeutics for children and 01:09:31.000 --> 01:09:34.000 aadd less cents 01:09:34.000 --> 01:09:35.000 through new preclinical models 01:09:35.000 --> 01:09:37.000 novel trial designs and use of 01:09:37.000 --> 01:09:39.000 real world data. UNDLY this 01:09:39.000 --> 01:09:41.000 this area there are several 01:09:41.000 --> 01:09:44.000 nder this area there are several 01:09:44.000 --> 01:09:45.000 knew topics, including research 01:09:45.000 --> 01:09:46.000 to facilitate common control 01:09:46.000 --> 01:09:49.000 designs in international 01:09:49.000 --> 01:09:50.000 pediatric clinical trials in 01:09:50.000 --> 01:09:53.000 oncology, research to validate 01:09:53.000 --> 01:09:55.000 early efficacy end points for 01:09:55.000 --> 01:09:56.000 pediatric oncology trials and 01:09:56.000 --> 01:09:58.000 research to investigate methods 01:09:58.000 --> 01:10:00.000 to recruit diverse populations 01:10:00.000 --> 01:10:01.000 of patients into pediatric 01:10:01.000 --> 01:10:04.000 oncology trials such as through 01:10:04.000 --> 01:10:07.000 developing best practices for 01:10:07.000 --> 01:10:08.000 for more patient and 01:10:08.000 --> 01:10:09.000 family/caregiver-friendly 01:10:09.000 --> 01:10:10.000 friendly methods for informed 01:10:10.000 --> 01:10:12.000 consent and conveying 01:10:12.000 --> 01:10:13.000 information about clinical trial 01:10:13.000 --> 01:10:14.000 participation. Next slide, 01:10:14.000 --> 01:10:17.000 please. 01:10:17.000 --> 01:10:18.000 In the area of precision 01:10:18.000 --> 01:10:19.000 oncology we're interested in 01:10:19.000 --> 01:10:22.000 applied research to develop and 01:10:22.000 --> 01:10:25.000 and deploy bio, makers 01:10:25.000 --> 01:10:27.000 including both moleccollar and 01:10:27.000 --> 01:10:30.000 imaging to accelerate and 01:10:30.000 --> 01:10:32.000 improve regulatory review of 01:10:32.000 --> 01:10:33.000 oncology products. In rare 01:10:33.000 --> 01:10:35.000 cancers we are interested in 01:10:35.000 --> 01:10:38.000 development of new approaches to 01:10:38.000 --> 01:10:39.000 support drug development such as 01:10:39.000 --> 01:10:41.000 such as drug we purposing and 01:10:41.000 --> 01:10:44.000 use of decentralize the elements 01:10:44.000 --> 01:10:45.000 including telemedicine and 01:10:45.000 --> 01:10:49.000 incorporation of other Prague 01:10:49.000 --> 01:10:50.000 pragmatic features and new to 01:10:50.000 --> 01:10:51.000 this area is the topic for the 01:10:51.000 --> 01:10:53.000 development of infrastructure 01:10:53.000 --> 01:10:55.000 structure for a coordination 01:10:55.000 --> 01:10:57.000 network and data repository for 01:10:57.000 --> 01:10:59.000 DA patient level data across 01:10:59.000 --> 01:11:02.000 institutions and internationally 01:11:02.000 --> 01:11:05.000 to support drug development and 01:11:05.000 --> 01:11:07.000 regulatory decision-making for 01:11:07.000 --> 01:11:08.000 ultra rare tumors. 01:11:08.000 --> 01:11:10.000 The final topic is our cross 01:11:10.000 --> 01:11:12.000 cutting area and has been 01:11:12.000 --> 01:11:13.000 brought up in several of the 01:11:13.000 --> 01:11:18.000 other areas in the previous 01:11:18.000 --> 01:11:21.000 slides. And that is 01:11:21.000 --> 01:11:23.000 real-world data UTitization. 01:11:23.000 --> 01:11:25.000 This focuses on approaches to 01:11:25.000 --> 01:11:26.000 evaluate, integrate and 01:11:26.000 --> 01:11:28.000 facilitate to generate high 01:11:28.000 --> 01:11:30.000 quality real-world evidence. In 01:11:30.000 --> 01:11:31.000 this area we're interested in 01:11:31.000 --> 01:11:32.000 innovative approaches such as 01:11:32.000 --> 01:11:36.000 clinical trials including Prague 01:11:36.000 --> 01:11:39.000 pragmatic elements and 01:11:39.000 --> 01:11:41.000 other designs. New to this 01:11:41.000 --> 01:11:43.000 area are an interest in methods 01:11:43.000 --> 01:11:46.000 focused research using 01:11:46.000 --> 01:11:48.000 artificial intelligence or 01:11:48.000 --> 01:11:50.000 machine learning approaches to 01:11:50.000 --> 01:11:51.000 analyze, assess and interpret 01:11:51.000 --> 01:11:54.000 the scientific literature or 01:11:54.000 --> 01:11:56.000 currently available evidence in 01:11:56.000 --> 01:11:58.000 in a novel way to apply 01:11:58.000 --> 01:12:00.000 real-world data to enhance 01:12:00.000 --> 01:12:01.000 knowledge of study methods and 01:12:01.000 --> 01:12:03.000 understanding potential uses in 01:12:03.000 --> 01:12:04.000 regulatory science including 01:12:04.000 --> 01:12:06.000 evaluation of data quality or 01:12:06.000 --> 01:12:09.000 approaches to data transparency. 01:12:09.000 --> 01:12:11.000 And to understand approaches to 01:12:11.000 --> 01:12:15.000 improve introduction of Prague 01:12:15.000 --> 01:12:17.000 pragmatic elements such as 01:12:17.000 --> 01:12:20.000 understanding clinical site 01:12:20.000 --> 01:12:21.000 site selection or enhancement 01:12:21.000 --> 01:12:23.000 of representation to enhance 01:12:23.000 --> 01:12:24.000 health equity. Next slide, 01:12:24.000 --> 01:12:28.000 please. 01:12:28.000 --> 01:12:30.000 This slide contains a link to a 01:12:30.000 --> 01:12:32.000 to a website that has 01:12:32.000 --> 01:12:35.000 descriptions of extra mural 01:12:35.000 --> 01:12:36.000 concepts that OCE is supporting 01:12:36.000 --> 01:12:39.000 including those awarded UPD the 01:12:39.000 --> 01:12:42.000 under the BAA program thank you 01:12:42.000 --> 01:12:45.000 so much for listening and we 01:12:45.000 --> 01:12:47.000 look forward to receiving 01:12:47.000 --> 01:12:49.000 proposals. I think there is 01:12:49.000 --> 01:12:52.000 time for questions if there are 01:12:52.000 --> 01:12:53.000 any in the chat. 01:12:53.000 --> 01:12:56.000 So I -- I don't see any 01:12:56.000 --> 01:12:57.000 questions. 01:12:57.000 --> 01:12:59.000 >>DR. KINNERA CHADA: Thank you, 01:12:59.000 --> 01:13:00.000 Dr. Zinn. 01:13:00.000 --> 01:13:01.000 >>DR. REBEKAH ZINN: Thank you. 01:13:01.000 --> 01:13:06.000 >>DR. KINNERA CHADA: Our next 01:13:06.000 --> 01:13:10.000 presentation is by Ms. Sarah 01:13:10.000 --> 01:13:12.000 from center for veterinary 01:13:12.000 --> 01:13:16.000 medicine. He she will be 01:13:16.000 --> 01:13:19.000 talking about CVM's research 01:13:19.000 --> 01:13:20.000 priority. 01:13:20.000 --> 01:13:22.000 >>MS. SARA SKLENKA: Can you 01:13:22.000 --> 01:13:23.000 hear me okay? 01:13:23.000 --> 01:13:24.000 >>DR. KINNERA CHADA: Yes. 01:13:24.000 --> 01:13:26.000 >>MS. SARA SKLENKA: All right. 01:13:26.000 --> 01:13:28.000 Well, hello everyone I'm Sarah 01:13:28.000 --> 01:13:33.000 Sklenka from the office of SUR 01:13:33.000 --> 01:13:36.000 surveillance 01:13:36.000 --> 01:13:38.000 and compliance. Thank you to 01:13:38.000 --> 01:13:40.000 the BAA day organizers for 01:13:40.000 --> 01:13:42.000 allowing me to present. The 01:13:42.000 --> 01:13:45.000 purpose of my presentation is to 01:13:45.000 --> 01:13:47.000 provide a brief overview of 01:13:47.000 --> 01:13:49.000 FDA's center for VED NAR 01:13:49.000 --> 01:13:52.000 medicine and our research 01:13:52.000 --> 01:13:53.000 veterinary medicine and our 01:13:53.000 --> 01:13:54.000 research priorities. Next slide 01:13:54.000 --> 01:13:55.000 . 01:13:55.000 --> 01:13:57.000 So for those who might not be 01:13:57.000 --> 01:13:58.000 familiar with the center for 01:13:58.000 --> 01:13:59.000 veterinary medicine we're a 01:13:59.000 --> 01:14:01.000 small center that is responsible 01:14:01.000 --> 01:14:03.000 for the regulation of drugs, 01:14:03.000 --> 01:14:06.000 foods, and medical devices for 01:14:06.000 --> 01:14:09.000 all animals. This includes 01:14:09.000 --> 01:14:12.000 livestock such as cattle swine 01:14:12.000 --> 01:14:14.000 and poultry as well as companion 01:14:14.000 --> 01:14:16.000 animals like cats, dogs and 01:14:16.000 --> 01:14:18.000 horses we're not only concerned 01:14:18.000 --> 01:14:19.000 with animal health, however, but 01:14:19.000 --> 01:14:21.000 human health as well which is 01:14:21.000 --> 01:14:23.000 reflected in our mission 01:14:23.000 --> 01:14:25.000 statement protecting human and 01:14:25.000 --> 01:14:28.000 animal health. 01:14:28.000 --> 01:14:32.000 Among the many things carve 01:14:32.000 --> 01:14:33.000 things CVM does one is 01:14:33.000 --> 01:14:35.000 to carry out research that 01:14:35.000 --> 01:14:40.000 helps to inform our PL sews and 01:14:40.000 --> 01:14:42.000 policies and regulatory 01:14:42.000 --> 01:14:44.000 decisions about animal food, 01:14:44.000 --> 01:14:45.000 drug and devices. Within this 01:14:45.000 --> 01:14:47.000 is the division of food 01:14:47.000 --> 01:14:49.000 compliance which is where my 01:14:49.000 --> 01:14:53.000 team the science policy branch 01:14:53.000 --> 01:14:54.000 branch sits we help to monitor 01:14:54.000 --> 01:14:56.000 the animal food supply for 01:14:56.000 --> 01:14:57.000 various con tam NANTS that are 01:14:57.000 --> 01:15:00.000 physical, biological and 01:15:00.000 --> 01:15:01.000 taminants that are physical, 01:15:01.000 --> 01:15:02.000 biological and chemical in 01:15:02.000 --> 01:15:05.000 nature through the contaminants 01:15:05.000 --> 01:15:09.000 program. 01:15:09.000 --> 01:15:11.000 PFAS is a current area of 01:15:11.000 --> 01:15:14.000 interest where more research are 01:15:14.000 --> 01:15:16.000 needed CVM's role to ensure a 01:15:16.000 --> 01:15:17.000 safe animal food supply is meant 01:15:17.000 --> 01:15:19.000 to be protective of both human 01:15:19.000 --> 01:15:22.000 and animal health. When we 01:15:22.000 --> 01:15:24.000 think about food for livestock 01:15:24.000 --> 01:15:27.000 not only do we want it to be 01:15:27.000 --> 01:15:29.000 safe for the specie consuming it 01:15:29.000 --> 01:15:31.000 but also for humans that might 01:15:31.000 --> 01:15:33.000 be eating consumable animal 01:15:33.000 --> 01:15:34.000 products such as meat, milk, and 01:15:34.000 --> 01:15:36.000 eggs. 01:15:36.000 --> 01:15:39.000 So the first potential project I 01:15:39.000 --> 01:15:41.000 would like to highlight is a 01:15:41.000 --> 01:15:45.000 dairy cattle study there's a 01:15:45.000 --> 01:15:46.000 lack of available data for PFAS 01:15:46.000 --> 01:15:48.000 and dairy cattle in the United 01:15:48.000 --> 01:15:52.000 States. This includes 01:15:52.000 --> 01:15:55.000 uncertainty around how PFAS may 01:15:55.000 --> 01:15:58.000 move through a dairy cow after 01:15:58.000 --> 01:16:01.000 aboral exposure such as food. 01:16:01.000 --> 01:16:02.000 While there is no data for the 01:16:02.000 --> 01:16:05.000 beef cattle the data and models 01:16:05.000 --> 01:16:07.000 concerning DARry cattle are 01:16:07.000 --> 01:16:10.000 dairy cattle are currently 01:16:10.000 --> 01:16:14.000 insufficient and -- to 01:16:14.000 --> 01:16:17.000 accurately predict PFAS 01:16:17.000 --> 01:16:18.000 bioaccumulation such as meat and 01:16:18.000 --> 01:16:19.000 milk. 01:16:19.000 --> 01:16:23.000 A more complicated model is 01:16:23.000 --> 01:16:25.000 needed for dairy cattle as their 01:16:25.000 --> 01:16:27.000 diet and physiology change 01:16:27.000 --> 01:16:28.000 depending on where they are at 01:16:28.000 --> 01:16:30.000 in their lackation cycle. We 01:16:30.000 --> 01:16:32.000 are interested in obtain 01:16:32.000 --> 01:16:34.000 real-world data to better inform 01:16:34.000 --> 01:16:38.000 our modelling efforts for an 01:16:38.000 --> 01:16:40.000 for an oral exposure of 01:16:40.000 --> 01:16:41.000 PFAS in a dairy cattle 01:16:41.000 --> 01:16:44.000 scenario. 01:16:44.000 --> 01:16:45.000 Research that NFGTs 01:16:45.000 --> 01:16:50.000 bioaccumulation of and 01:16:50.000 --> 01:16:52.000 investigates bioaccumulation of 01:16:52.000 --> 01:16:55.000 and distribution of PFAS in 01:16:55.000 --> 01:16:59.000 dairy cattle and other products. 01:16:59.000 --> 01:17:01.000 We are interested in those 01:17:01.000 --> 01:17:03.000 listed in the first bullet. 01:17:03.000 --> 01:17:05.000 Such a study would ideally cover 01:17:05.000 --> 01:17:09.000 a minimum of two lackation 01:17:09.000 --> 01:17:12.000 cycles in order to monitor 01:17:12.000 --> 01:17:13.000 to monitor temporal VAEBLT 01:17:13.000 --> 01:17:17.000 temporal availability. Samples 01:17:17.000 --> 01:17:20.000 of input such as food and water, 01:17:20.000 --> 01:17:22.000 ex3 at a, urine and phi assesses 01:17:22.000 --> 01:17:26.000 and tissues such as blood, 01:17:26.000 --> 01:17:31.000 organs muscles and 01:17:31.000 --> 01:17:34.000 and milks could be collection 01:17:34.000 --> 01:17:36.000 at different times. As FDA 01:17:36.000 --> 01:17:38.000 does have in-house laboratory 01:17:38.000 --> 01:17:40.000 laboratory capabilities to do 01:17:40.000 --> 01:17:42.000 to do the analytical testing of 01:17:42.000 --> 01:17:43.000 samples. 01:17:43.000 --> 01:17:46.000 With this slide I would just 01:17:46.000 --> 01:17:48.000 like to highlight where in the 01:17:48.000 --> 01:17:50.000 FY25BAA notice document a 01:17:50.000 --> 01:17:52.000 potential dairy cattle study 01:17:52.000 --> 01:17:54.000 would fall this particular 01:17:54.000 --> 01:17:58.000 research area of interest falls 01:17:58.000 --> 01:17:59.000 under charge III invigorate 01:17:59.000 --> 01:18:02.000 public health preparedness in 01:18:02.000 --> 01:18:05.000 response to FDA patient and 01:18:05.000 --> 01:18:06.000 could be consumers under number 01:18:06.000 --> 01:18:10.000 2, veterinary medicine. In the 01:18:10.000 --> 01:18:11.000 spirit of one health CVM works 01:18:11.000 --> 01:18:13.000 to support and spur development 01:18:13.000 --> 01:18:14.000 of new technologies and 01:18:14.000 --> 01:18:16.000 approaches that address health 01:18:16.000 --> 01:18:18.000 needs across human, animal and 01:18:18.000 --> 01:18:19.000 environmental sectors. Next 01:18:19.000 --> 01:18:22.000 slide. 01:18:22.000 --> 01:18:23.000 The second research focus I 01:18:23.000 --> 01:18:28.000 would like to highlight are new 01:18:28.000 --> 01:18:29.000 approach methods or NAMs 01:18:29.000 --> 01:18:31.000 for companion animals there is 01:18:31.000 --> 01:18:36.000 currently a lack of data 01:18:36.000 --> 01:18:40.000 available 01:18:40.000 --> 01:18:42.000 for PFAS in companion animals 01:18:42.000 --> 01:18:45.000 including cats and dogs. 01:18:45.000 --> 01:18:48.000 Alternatives should be explored. 01:18:48.000 --> 01:18:50.000 Addition DMLly, while 01:18:50.000 --> 01:18:52.000 extrapolation from rodents to 01:18:52.000 --> 01:18:53.000 ally, while extrapolation from 01:18:53.000 --> 01:18:55.000 rodents to other animal species 01:18:55.000 --> 01:18:56.000 this is not always accurate due 01:18:56.000 --> 01:18:59.000 to physiological species 01:18:59.000 --> 01:19:02.000 differences. 01:19:02.000 --> 01:19:04.000 Toxicity pathways in cats and 01:19:04.000 --> 01:19:07.000 dogs maybe similar oar or 01:19:07.000 --> 01:19:12.000 or different because of protein 01:19:12.000 --> 01:19:16.000 expression, or diet 01:19:16.000 --> 01:19:18.000 . CVM real 01:19:18.000 --> 01:19:23.000 realizes that this can be a 01:19:23.000 --> 01:19:24.000 valuable food, ensure safety of 01:19:24.000 --> 01:19:27.000 animal food. 01:19:27.000 --> 01:19:30.000 CVM is interested in developing 01:19:30.000 --> 01:19:34.000 a strategy of using MAMs of 01:19:34.000 --> 01:19:37.000 toxicity in cats and dogs. NAMs 01:19:37.000 --> 01:19:41.000 are able to go throughing to 01:19:41.000 --> 01:19:45.000 see I say tea data such as 01:19:45.000 --> 01:19:48.000 tools, in3 TROE exXRAPlation. 01:19:48.000 --> 01:19:50.000 And other techniques. When used 01:19:50.000 --> 01:19:53.000 together NAMs tell a story of 01:19:53.000 --> 01:19:55.000 the plausible toxic ends points 01:19:55.000 --> 01:19:57.000 and levels for specific species. 01:19:57.000 --> 01:20:00.000 I wouldic a lot to emphasize 01:20:00.000 --> 01:20:02.000 here that CVM envisions to 01:20:02.000 --> 01:20:04.000 potential project to occur in 01:20:04.000 --> 01:20:06.000 in two phases the first phase 01:20:06.000 --> 01:20:08.000 which we're interested would be 01:20:08.000 --> 01:20:10.000 for developing a comprehensive 01:20:10.000 --> 01:20:13.000 plan and budget for carrying out 01:20:13.000 --> 01:20:15.000 this work. Next slide. 01:20:15.000 --> 01:20:18.000 Again I would like to highlight 01:20:18.000 --> 01:20:20.000 where in the notice document 01:20:20.000 --> 01:20:22.000 this potential research PFAS in 01:20:22.000 --> 01:20:25.000 cats and dogs using new approach 01:20:25.000 --> 01:20:27.000 methods would fall under charge 01:20:27.000 --> 01:20:29.000 1, modernize development and 01:20:29.000 --> 01:20:32.000 evaluation of FDA-regulated 01:20:32.000 --> 01:20:33.000 products under section A, 01:20:33.000 --> 01:20:35.000 alternative methods, number 5, 01:20:35.000 --> 01:20:36.000 5, veterinary medicine. Next 01:20:36.000 --> 01:20:37.000 slide. And that's all I have 01:20:37.000 --> 01:20:39.000 for you this afternoon. Thank 01:20:39.000 --> 01:20:41.000 you again to the organizers for 01:20:41.000 --> 01:20:42.000 putting on this event and 01:20:42.000 --> 01:20:47.000 allowing me to share just some 01:20:47.000 --> 01:20:48.000 of CVM's current PFAS research 01:20:48.000 --> 01:20:49.000 priorities. I don't see any 01:20:49.000 --> 01:20:51.000 questions in the chat right now 01:20:51.000 --> 01:20:54.000 but we'll be sure to keep an eye 01:20:54.000 --> 01:20:56.000 on that and can answer any that 01:20:56.000 --> 01:20:59.000 may come in. Thank you. 01:20:59.000 --> 01:21:04.000 >>DR. KINNERA CHADA: Thank you, 01:21:04.000 --> 01:21:09.000 Ms. SKEN CLA 01:21:09.000 --> 01:21:10.000 . Our next is captain 01:21:10.000 --> 01:21:13.000 skinner. She is will be 01:21:13.000 --> 01:21:17.000 talking about one health 01:21:17.000 --> 01:21:43.000 research priorities 01:21:43.000 --> 01:21:44.000 klenka. Our next is captain 01:21:44.000 --> 01:21:47.000 skinner. She is will be talking about one health research 01:21:47.000 --> 01:22:04.000 priorities 01:22:04.000 --> 01:22:15.000 . 01:22:15.000 --> 01:22:16.000 . While we are pulling up the 01:22:16.000 --> 01:22:17.000 slides I would like to make an 01:22:17.000 --> 01:22:19.000 announcement that if you have 01:22:19.000 --> 01:22:23.000 any questions for the previous 01:22:23.000 --> 01:22:24.000 presenters put them in the Q & A 01:22:24.000 --> 01:22:26.000 chat box we will be able to 01:22:26.000 --> 01:22:31.000 check with them and later post 01:22:31.000 --> 01:22:48.000 it on the event page. Thank you 01:22:48.000 --> 01:22:49.000 . So Sarah, if you are still 01:22:49.000 --> 01:22:53.000 available there is a question 01:22:53.000 --> 01:22:54.000 for you 01:22:54.000 --> 01:22:55.000 . 01:22:55.000 --> 01:22:59.000 >>MS. SARA SKLENKA: Yes, I see 01:22:59.000 --> 01:23:03.000 it. So are we more interested 01:23:03.000 --> 01:23:05.000 in PFAS animal kinetics 01:23:05.000 --> 01:23:06.000 for this project more 01:23:06.000 --> 01:23:10.000 interested in the animal 01:23:10.000 --> 01:23:12.000 kinetics and how PFAS may move 01:23:12.000 --> 01:23:13.000 through the animal and 01:23:13.000 --> 01:23:14.000 distribute to different partses 01:23:14.000 --> 01:23:16.000 partses of the animal and its 01:23:16.000 --> 01:23:18.000 outputs. So hopefully, that 01:23:18.000 --> 01:23:19.000 answers that question. 01:23:19.000 --> 01:23:49.000 >>DR. KINNERA CHADA: Thank you, 01:23:56.000 --> 01:23:57.000 of the animal and its outputs. 01:23:57.000 --> 01:23:58.000 So hopefully, that answers that 01:23:58.000 --> 01:23:59.000 question. >>DR. KINNERA CHADA: Thank you, 01:23:59.000 --> 01:24:00.000 Sarah. 01:24:00.000 --> 01:24:01.000 >> Just give me one moment I'm 01:24:01.000 --> 01:24:02.000 trying to get the narration to 01:24:02.000 --> 01:24:03.000 play. It's not playing 01:24:03.000 --> 01:24:33.000 currently. 01:24:33.000 --> 01:24:34.000 >>DR. KINNERA CHADA: Thank you. 01:24:34.000 --> 01:24:35.000 01:24:35.000 --> 01:24:37.000 >> I think there's another 01:24:37.000 --> 01:24:39.000 question related to our projects 01:24:39.000 --> 01:24:40.000 if I can answer that. 01:24:40.000 --> 01:24:41.000 >>DR. KINNERA CHADA: Sure, 01:24:41.000 --> 01:24:42.000 please. 01:24:42.000 --> 01:24:45.000 >> So the question is. . Will 01:24:45.000 --> 01:24:50.000 the question is: Will you 01:24:50.000 --> 01:24:53.000 accept dairy sheep or goat? So 01:24:53.000 --> 01:24:55.000 at CVM we are definitely 01:24:55.000 --> 01:24:57.000 interested in all animals 01:24:57.000 --> 01:24:59.000 however that's a big scope. So 01:24:59.000 --> 01:25:00.000 in order to kind of prioritize 01:25:00.000 --> 01:25:03.000 with a we would like to do 01:25:03.000 --> 01:25:05.000 especially in the PFAS space 01:25:05.000 --> 01:25:07.000 would be to focus on the dairy 01:25:07.000 --> 01:25:10.000 study proposal first and then 01:25:10.000 --> 01:25:14.000 maybe if the future, explore 01:25:14.000 --> 01:25:17.000 other species. But definitely 01:25:17.000 --> 01:25:18.000 dairy cattle for right now. 01:25:18.000 --> 01:25:21.000 >>DR. KINNERA CHADA: Thank you, 01:25:21.000 --> 01:25:23.000 Sarah. So Sheldon, um, captain 01:25:23.000 --> 01:25:24.000 skinner is available. She can 01:25:24.000 --> 01:25:28.000 present if there are any issues 01:25:28.000 --> 01:25:29.000 with the recording, audio for 01:25:29.000 --> 01:25:30.000 for the recording. 01:25:30.000 --> 01:25:33.000 01:25:33.000 --> 01:25:37.000 >> Perfect. Great 01:25:37.000 --> 01:25:40.000 . Thank you for your patience. 01:25:40.000 --> 01:25:41.000 Please go ahead. 01:25:41.000 --> 01:25:42.000 >>CAPT. BRIANNA SKINNER: TLAUNG 01:25:42.000 --> 01:25:43.000 01:25:43.000 --> 01:25:44.000 >>CAPT. BRIANNA SKINNER: Thank 01:25:44.000 --> 01:25:46.000 you everyone. So thank you for 01:25:46.000 --> 01:25:48.000 attending BBA day. Can even 01:25:48.000 --> 01:25:50.000 Can everyone hear me? 01:25:50.000 --> 01:25:51.000 >> Yes. 01:25:51.000 --> 01:25:53.000 >>CAPT. BRIANNA SKINNER: Okay. 01:25:53.000 --> 01:25:58.000 So as already been introduced my 01:25:58.000 --> 01:26:03.000 name's captain BRIE I can't in a 01:26:03.000 --> 01:26:04.000 skinner I'm a vet nareuation 01:26:04.000 --> 01:26:05.000 under the office of the chief 01:26:05.000 --> 01:26:10.000 scientists so one health is 01:26:10.000 --> 01:26:11.000 rianna skinner I'm a vet 01:26:11.000 --> 01:26:12.000 nareuation under the office of 01:26:12.000 --> 01:26:13.000 the chief scientists so one 01:26:13.000 --> 01:26:15.000 health is listed. Identified 01:26:15.000 --> 01:26:18.000 under charge III which is to 01:26:18.000 --> 01:26:20.000 invigorate public health 01:26:20.000 --> 01:26:22.000 preparedness. So during this 01:26:22.000 --> 01:26:24.000 portion, I will discuss what one 01:26:24.000 --> 01:26:29.000 health is, how it is utilized 01:26:29.000 --> 01:26:31.000 and how one health is integral 01:26:31.000 --> 01:26:33.000 in FDA's mission I will also 01:26:33.000 --> 01:26:35.000 summarize FDA's one health 01:26:35.000 --> 01:26:36.000 priorities and its relevance to 01:26:36.000 --> 01:26:41.000 the agencies's regulatory 01:26:41.000 --> 01:26:42.000 mission. 01:26:42.000 --> 01:26:45.000 Next slide. 01:26:45.000 --> 01:26:46.000 So what is one health? It can 01:26:46.000 --> 01:26:48.000 be defined in various ways and 01:26:48.000 --> 01:26:52.000 some definition focus on a triad 01:26:52.000 --> 01:26:54.000 where you look at human, animal, 01:26:54.000 --> 01:26:58.000 environmental health where 01:26:58.000 --> 01:27:00.000 others expand this to also 01:27:00.000 --> 01:27:03.000 includes plants alongside 01:27:03.000 --> 01:27:05.000 peoples, animals and 01:27:05.000 --> 01:27:08.000 environment. So the definition 01:27:08.000 --> 01:27:11.000 shown on this slide is on the 01:27:11.000 --> 01:27:12.000 CDC website and has been adopted 01:27:12.000 --> 01:27:14.000 by the U.S. government but 01:27:14.000 --> 01:27:16.000 but overall one health is a 01:27:16.000 --> 01:27:19.000 concept that TAEGs a holistic 01:27:19.000 --> 01:27:21.000 takes a holistic approach to 01:27:21.000 --> 01:27:24.000 health issues and acknowledging 01:27:24.000 --> 01:27:26.000 the interconnectedness of human, 01:27:26.000 --> 01:27:29.000 animal and environmental health 01:27:29.000 --> 01:27:31.000 and sometimes plants are 01:27:31.000 --> 01:27:33.000 included so I will discuss how 01:27:33.000 --> 01:27:34.000 the framework is applied. 01:27:34.000 --> 01:27:37.000 So one health looks at different 01:27:37.000 --> 01:27:39.000 components and topics related to 01:27:39.000 --> 01:27:41.000 health issues in each of the 01:27:41.000 --> 01:27:42.000 domains which includes human, 01:27:42.000 --> 01:27:44.000 animal and the environment. So 01:27:44.000 --> 01:27:45.000 within those various components 01:27:45.000 --> 01:27:47.000 and topics you will look at 01:27:47.000 --> 01:27:48.000 commonalities as well as 01:27:48.000 --> 01:27:51.000 correlations of health issues 01:27:51.000 --> 01:27:53.000 that are assessed. Taken into 01:27:53.000 --> 01:27:55.000 consideration the con texts and 01:27:55.000 --> 01:27:58.000 impact of those health issues. 01:27:58.000 --> 01:27:59.000 So one health concept is often 01:27:59.000 --> 01:28:02.000 combined with other frameworks 01:28:02.000 --> 01:28:05.000 known as the socioecological 01:28:05.000 --> 01:28:08.000 model because they both have a 01:28:08.000 --> 01:28:10.000 multidisciplinary focus with an 01:28:10.000 --> 01:28:11.000 emphasis on interconnected 01:28:11.000 --> 01:28:13.000 systems. So within the 01:28:13.000 --> 01:28:14.000 integration of human, animal and 01:28:14.000 --> 01:28:16.000 environmental factors we combine 01:28:16.000 --> 01:28:18.000 that with the socioecological 01:28:18.000 --> 01:28:19.000 model which also considers 01:28:19.000 --> 01:28:20.000 multilevel influences of health 01:28:20.000 --> 01:28:22.000 based on the determinants of 01:28:22.000 --> 01:28:24.000 of social and environmental 01:28:24.000 --> 01:28:27.000 outcomes that may impact small 01:28:27.000 --> 01:28:29.000 groups which we consider the MIE 01:28:29.000 --> 01:28:31.000 row level, CHELS the larger 01:28:31.000 --> 01:28:32.000 populations which we consider 01:28:32.000 --> 01:28:34.000 the macro level and using the 01:28:34.000 --> 01:28:36.000 socioecological model with one 01:28:36.000 --> 01:28:39.000 one health MIE heights how 01:28:39.000 --> 01:28:41.000 changes or problems at one level 01:28:41.000 --> 01:28:42.000 can affect all other layers, 01:28:42.000 --> 01:28:45.000 including animal and human 01:28:45.000 --> 01:28:47.000 health emphasizing those 01:28:47.000 --> 01:28:49.000 solutions must address these 01:28:49.000 --> 01:28:50.000 interactions comprehensively. 01:28:50.000 --> 01:28:53.000 Next slide, please. 01:28:53.000 --> 01:28:56.000 So now, we'll discuss how one 01:28:56.000 --> 01:29:00.000 one health is relevant to the 01:29:00.000 --> 01:29:01.000 mission. So it presents a more 01:29:01.000 --> 01:29:03.000 holistic view. So the 01:29:03.000 --> 01:29:06.000 convergence of one health 01:29:06.000 --> 01:29:07.000 activities already exists in 01:29:07.000 --> 01:29:08.000 in FDA's mission when you 01:29:08.000 --> 01:29:11.000 consider agency's 01:29:11.000 --> 01:29:13.000 responsibilities and THORTSZ. 01:29:13.000 --> 01:29:16.000 The effort to improve health 01:29:16.000 --> 01:29:17.000 goes beyond recognizing disease 01:29:17.000 --> 01:29:22.000 transmissions of #450U78 health 01:29:22.000 --> 01:29:23.000 but it also AK FLOJing human- 01:29:23.000 --> 01:29:26.000 human health but it also AK 01:29:26.000 --> 01:29:28.000 FLOJing human-animal factors. 01:29:28.000 --> 01:29:31.000 The agency fulfills its mission 01:29:31.000 --> 01:29:32.000 for the benefit of both people 01:29:32.000 --> 01:29:34.000 and animals by ensuring the 01:29:34.000 --> 01:29:36.000 safety and efficacy of 01:29:36.000 --> 01:29:38.000 regulatory products such as 01:29:38.000 --> 01:29:40.000 human and animal foods, human 01:29:40.000 --> 01:29:42.000 biologics and these can be 01:29:42.000 --> 01:29:43.000 derived from non-human animal 01:29:43.000 --> 01:29:44.000 sources and also human and 01:29:44.000 --> 01:29:48.000 animal medical devices as well 01:29:48.000 --> 01:29:52.000 as well as radiation-emitting 01:29:52.000 --> 01:29:55.000 products so it regulates 01:29:55.000 --> 01:29:57.000 the distribution of regulatory 01:29:57.000 --> 01:29:58.000 products to ensure safety and 01:29:58.000 --> 01:30:02.000 quality standards are met that 01:30:02.000 --> 01:30:05.000 are beneficial for both people 01:30:05.000 --> 01:30:07.000 and animals FDA also encourages 01:30:07.000 --> 01:30:08.000 collaborations that embrace 01:30:08.000 --> 01:30:11.000 technologies beneficial for 01:30:11.000 --> 01:30:13.000 for people and the various 01:30:13.000 --> 01:30:18.000 species. So they coordinate 01:30:18.000 --> 01:30:20.000 these regular La pathways 01:30:20.000 --> 01:30:23.000 measuring how they pleasure the 01:30:23.000 --> 01:30:27.000 they measure the advancement 01:30:27.000 --> 01:30:28.000 of. -- intentional and 01:30:28.000 --> 01:30:31.000 nonintentional emerging threats, 01:30:31.000 --> 01:30:34.000 chemical, biological, ready 01:30:34.000 --> 01:30:37.000 logical or nuclear materials. 01:30:37.000 --> 01:30:40.000 . Next slide. We're going to 01:30:40.000 --> 01:30:43.000 talk about FDA's initiative 01:30:43.000 --> 01:30:45.000 began in 29 TOOEP. So the 01:30:45.000 --> 01:30:48.000 19. So the acting commissioner 01:30:48.000 --> 01:30:50.000 er at that time would enGAEBLG 01:30:50.000 --> 01:30:51.000 all centers in one health 01:30:51.000 --> 01:30:54.000 gage all centers in one health 01:30:54.000 --> 01:30:57.000 agency-wide representation the 01:30:57.000 --> 01:30:58.000 engagement in the one health 01:30:58.000 --> 01:31:01.000 initiative and this committee is 01:31:01.000 --> 01:31:03.000 composed of FDA shall have that 01:31:03.000 --> 01:31:05.000 are directors, deputy directors 01:31:05.000 --> 01:31:10.000 as well as senior advisers and 01:31:10.000 --> 01:31:12.000 consultants the vision and 01:31:12.000 --> 01:31:16.000 mission shown of the slide 01:31:16.000 --> 01:31:20.000 depicts FD ACHL 01:31:20.000 --> 01:31:22.000 FDA's perspective. So our 01:31:22.000 --> 01:31:24.000 vision is to have optimal public 01:31:24.000 --> 01:31:25.000 outcomes for human and animals 01:31:25.000 --> 01:31:27.000 in their shared environment and 01:31:27.000 --> 01:31:29.000 how we're going to do this is 01:31:29.000 --> 01:31:31.000 through the mission our one 01:31:31.000 --> 01:31:32.000 health mission which is we're 01:31:32.000 --> 01:31:34.000 going to collaborate with stake 01:31:34.000 --> 01:31:37.000 holders across disciplines and 01:31:37.000 --> 01:31:39.000 sectors to promote the health of 01:31:39.000 --> 01:31:41.000 humans, animals the environment 01:31:41.000 --> 01:31:44.000 using science, technology and 01:31:44.000 --> 01:31:46.000 innovation and BAA day is part 01:31:46.000 --> 01:31:50.000 of us doing that. Next 01:31:50.000 --> 01:31:51.000 Next slide please. 01:31:51.000 --> 01:31:53.000 So you can see messages that 01:31:53.000 --> 01:31:55.000 were accept from FDA's 01:31:55.000 --> 01:31:57.000 commissioner's office on the 01:31:57.000 --> 01:32:00.000 social media platform formally 01:32:00.000 --> 01:32:03.000 known as Twitter. And as you 01:32:03.000 --> 01:32:04.000 see, one health is listed as a 01:32:04.000 --> 01:32:06.000 priority in the call to action 01:32:06.000 --> 01:32:07.000 for the biomedical science 01:32:07.000 --> 01:32:08.000 community as well as the 01:32:08.000 --> 01:32:11.000 clinical communities. So please 01:32:11.000 --> 01:32:13.000 take notice to one health is 01:32:13.000 --> 01:32:15.000 mentioned in relevance to data 01:32:15.000 --> 01:32:19.000 sharing and protection of data, 01:32:19.000 --> 01:32:24.000 national, global SUR vie YENS, 01:32:24.000 --> 01:32:25.000 antiMIE croakerial resistance 01:32:25.000 --> 01:32:26.000 so it's recognized even within 01:32:26.000 --> 01:32:27.000 microbial resistance so it's 01:32:27.000 --> 01:32:29.000 recognized even within the 01:32:29.000 --> 01:32:33.000 highest level of the agency. 01:32:33.000 --> 01:32:34.000 So in 2022, FDA surveyed 01:32:34.000 --> 01:32:36.000 nine centers and offices to 01:32:36.000 --> 01:32:38.000 determine what their one health 01:32:38.000 --> 01:32:41.000 priorities here. So this slide 01:32:41.000 --> 01:32:43.000 is showing not only that the 01:32:43.000 --> 01:32:44.000 events of that survey, but 01:32:44.000 --> 01:32:46.000 something that also emerged 01:32:46.000 --> 01:32:50.000 recently as you can see with the 01:32:50.000 --> 01:32:55.000 research and response to the on 01:32:55.000 --> 01:32:56.000 going aviation influenza. So 01:32:56.000 --> 01:32:58.000 the list shows the themes that 01:32:58.000 --> 01:33:01.000 were collected in this SAUR VA. 01:33:01.000 --> 01:33:02.000 The first topic in blue as I 01:33:02.000 --> 01:33:03.000 survey. The first topic in blue 01:33:03.000 --> 01:33:06.000 as I mentioneded earlier was 01:33:06.000 --> 01:33:10.000 was recently added as a 01:33:10.000 --> 01:33:14.000 priority due to the influenza 01:33:14.000 --> 01:33:15.000 outbreak. E resistance, 01:33:15.000 --> 01:33:18.000 pandemic will have related 01:33:18.000 --> 01:33:20.000 topics and were the priorities 01:33:20.000 --> 01:33:22.000 surveyed. Technology, 01:33:22.000 --> 01:33:23.000 regulatory enforcement topics 01:33:23.000 --> 01:33:26.000 ask XAS XOOE building and 01:33:26.000 --> 01:33:28.000 resource needs were 01:33:28.000 --> 01:33:31.000 subcategories within those three 01:33:31.000 --> 01:33:35.000 topics shown in the black font. 01:33:35.000 --> 01:33:38.000 . Next slide, please. 01:33:38.000 --> 01:33:39.000 So now let's go over some 01:33:39.000 --> 01:33:41.000 recommendations for the 01:33:41.000 --> 01:33:43.000 announcement proposal. So the 01:33:43.000 --> 01:33:48.000 first two requirements are high 01:33:48.000 --> 01:33:52.000 highlighted 01:33:52.000 --> 01:33:54.000 in the blue font. So 01:33:54.000 --> 01:33:55.000 must recognize the 01:33:55.000 --> 01:33:56.000 interconnectiveness of the human 01:33:56.000 --> 01:33:57.000 health in a shared environment 01:33:57.000 --> 01:34:00.000 and it also needs to align with 01:34:00.000 --> 01:34:03.000 with the regulatory admission 01:34:03.000 --> 01:34:04.000 mission and the project must 01:34:04.000 --> 01:34:07.000 align with the roles and the 01:34:07.000 --> 01:34:08.000 responsibilities as it relates 01:34:08.000 --> 01:34:11.000 do the mission. So if a 01:34:11.000 --> 01:34:14.000 proposal meets these two 01:34:14.000 --> 01:34:17.000 criteria, it is more likely to 01:34:17.000 --> 01:34:20.000 to advance. They must MREET 01:34:20.000 --> 01:34:21.000 those two, or else they may not 01:34:21.000 --> 01:34:23.000 be considered. Therefore it's 01:34:23.000 --> 01:34:24.000 meet those two, or else they may 01:34:24.000 --> 01:34:25.000 not be considered. Therefore 01:34:25.000 --> 01:34:26.000 it's important that I emphasize 01:34:26.000 --> 01:34:28.000 those two. 01:34:28.000 --> 01:34:31.000 Now the other cry tear why 01:34:31.000 --> 01:34:34.000 listed below are other KREMD 01:34:34.000 --> 01:34:37.000 DAEGSs but this is not 01:34:37.000 --> 01:34:38.000 comprehensive of all of the comp 01:34:38.000 --> 01:34:40.000 all of the comp HEPGS so we do 01:34:40.000 --> 01:34:42.000 also encourage one health 01:34:42.000 --> 01:34:44.000 submissions as long as it goes 01:34:44.000 --> 01:34:50.000 LOOPG with the missions and 01:34:50.000 --> 01:34:53.000 utilizes a one health approach 01:34:53.000 --> 01:34:54.000 along with the missions and 01:34:54.000 --> 01:34:56.000 utilizes a one health approach. 01:34:56.000 --> 01:34:58.000 So the FDA has been using the 01:34:58.000 --> 01:35:02.000 one health approach for a long 01:35:02.000 --> 01:35:04.000 time. So this slide uses just a 01:35:04.000 --> 01:35:06.000 few examples though it is not an 01:35:06.000 --> 01:35:08.000 exhaustive list. And the reason 01:35:08.000 --> 01:35:09.000 we're giving you some examples 01:35:09.000 --> 01:35:10.000 not to say that you have to use 01:35:10.000 --> 01:35:14.000 these particular methods but 01:35:14.000 --> 01:35:19.000 because the one health topic is 01:35:19.000 --> 01:35:20.000 relatively new to FDA 01:35:20.000 --> 01:35:23.000 BAA's day we don't have a lot 01:35:23.000 --> 01:35:24.000 of background to share. So one 01:35:24.000 --> 01:35:27.000 health by gathering information 01:35:27.000 --> 01:35:29.000 and safety data to establish 01:35:29.000 --> 01:35:30.000 policy, standards guidance 01:35:30.000 --> 01:35:32.000 technology and innovation for 01:35:32.000 --> 01:35:34.000 for the products it regular 01:35:34.000 --> 01:35:35.000 LAETS. It is also used to 01:35:35.000 --> 01:35:39.000 tes. It is also used to educate 01:35:39.000 --> 01:35:44.000 outreach, and training 01:35:44.000 --> 01:35:46.000 and FDA utilizings a one 01:35:46.000 --> 01:35:49.000 health approach through 01:35:49.000 --> 01:35:50.000 research and SU valence. By 01:35:50.000 --> 01:35:53.000 supporting the development of 01:35:53.000 --> 01:35:55.000 of products that the FDA 01:35:55.000 --> 01:35:57.000 regulates so I hope these 01:35:57.000 --> 01:35:59.000 examples would give you some 01:35:59.000 --> 01:36:02.000 ideas when submitting proposals. 01:36:02.000 --> 01:36:03.000 surveillance. By supporting the 01:36:03.000 --> 01:36:04.000 development of products that the 01:36:04.000 --> 01:36:05.000 FDA regulates so I hope these 01:36:05.000 --> 01:36:06.000 examples would give you some ideas when submitting 01:36:06.000 --> 01:36:07.000 proposals. 01:36:07.000 --> 01:36:08.000 So this slide is just additional 01:36:08.000 --> 01:36:09.000 information on the one health 01:36:09.000 --> 01:36:11.000 health initiative and it also 01:36:11.000 --> 01:36:13.000 includes references where you 01:36:13.000 --> 01:36:14.000 can access to gain more insight 01:36:14.000 --> 01:36:16.000 so I hope you found this 01:36:16.000 --> 01:36:18.000 presentation informative and 01:36:18.000 --> 01:36:22.000 this ends the presentation for 01:36:22.000 --> 01:36:23.000 for the one health 01:36:23.000 --> 01:36:25.000 BA A. That concludes the 01:36:25.000 --> 01:36:30.000 presentation and I am willing to 01:36:30.000 --> 01:36:36.000 take any questions 01:36:36.000 --> 01:36:37.000 . 01:36:37.000 --> 01:36:38.000 01:36:38.000 --> 01:36:41.000 >>DR. KINNERA CHADA: We do have 01:36:41.000 --> 01:36:43.000 a question, captain Skinner. 01:36:43.000 --> 01:36:44.000 [MESSAGE IN CHAT BOX]. 01:36:44.000 --> 01:36:47.000 >>CAPT. BRIANNA SKINNER: Can 01:36:47.000 --> 01:36:50.000 you speak to what influence one 01:36:50.000 --> 01:36:52.000 one health had on the funding 01:36:52.000 --> 01:36:53.000 and whether one health is 01:36:53.000 --> 01:36:58.000 planning to independently select 01:36:58.000 --> 01:37:01.000 proposals itself next cycle? 01:37:01.000 --> 01:37:03.000 ? So we didn't have any propose 01:37:03.000 --> 01:37:06.000 proposals like I said. We did, 01:37:06.000 --> 01:37:08.000 actually. However with any 01:37:08.000 --> 01:37:11.000 proposal it goes through a 01:37:11.000 --> 01:37:14.000 review process and it depends on 01:37:14.000 --> 01:37:15.000 also what the agency considers a 01:37:15.000 --> 01:37:18.000 priority at that time. So with 01:37:18.000 --> 01:37:20.000 that, it goes through the review 01:37:20.000 --> 01:37:22.000 process based on, you know, what 01:37:22.000 --> 01:37:24.000 the needs of the agencies are at 01:37:24.000 --> 01:37:26.000 that time. And as a relatively 01:37:26.000 --> 01:37:28.000 new topic, it's not as 01:37:28.000 --> 01:37:30.000 established as the other ones 01:37:30.000 --> 01:37:33.000 but we do encourage others to 01:37:33.000 --> 01:37:36.000 to continue to think about one 01:37:36.000 --> 01:37:37.000 health proposals using a 01:37:37.000 --> 01:37:39.000 holistic approach because it 01:37:39.000 --> 01:37:44.000 does have merit and we hope that 01:37:44.000 --> 01:37:45.000 any proposals that you bring 01:37:45.000 --> 01:37:47.000 forth we can also collaborate 01:37:47.000 --> 01:37:49.000 with other centers or topics 01:37:49.000 --> 01:37:51.000 that may be of similar interest. 01:37:51.000 --> 01:38:01.000 I hope that answered the 01:38:01.000 --> 01:38:03.000 question. And also there was a 01:38:03.000 --> 01:38:07.000 a lack of funds as the reason 01:38:07.000 --> 01:38:08.000 for the health-related proposal 01:38:08.000 --> 01:38:10.000 . 01:38:10.000 --> 01:38:12.000 >>DR. KINNERA CHADA: Thank you 01:38:12.000 --> 01:38:17.000 captain skinner. Our next 01:38:17.000 --> 01:38:19.000 presenter is Dr. Joyce Obi 01:38:19.000 --> 01:38:23.000 Obidi from office of women's 01:38:23.000 --> 01:38:27.000 's health she will be presenting 01:38:27.000 --> 01:38:30.000 OWH research priorities. Joyce 01:38:30.000 --> 01:38:31.000 . 01:38:31.000 --> 01:38:33.000 >>DR. JOYCE OBIDI: Thank you 01:38:33.000 --> 01:38:35.000 everyone I am Joyce, health 01:38:35.000 --> 01:38:37.000 programs coordinator in the 01:38:37.000 --> 01:38:38.000 office of women's health and I 01:38:38.000 --> 01:38:41.000 am happy to speak to you good 01:38:41.000 --> 01:38:44.000 to you today about the research 01:38:44.000 --> 01:38:47.000 priorities of -- for our office. 01:38:47.000 --> 01:38:49.000 I thought I would start by 01:38:49.000 --> 01:38:50.000 giving a brief background on the 01:38:50.000 --> 01:38:51.000 office and our research program 01:38:51.000 --> 01:38:56.000 to help you better understand 01:38:56.000 --> 01:39:04.000 our research goals. 01:39:04.000 --> 01:39:06.000 FDA office of women's health was 01:39:06.000 --> 01:39:07.000 was established for clinical 01:39:07.000 --> 01:39:10.000 trials and to encourage the 01:39:10.000 --> 01:39:11.000 completion of sex and gender 01:39:11.000 --> 01:39:13.000 analysis not only for the study 01:39:13.000 --> 01:39:15.000 for the study submitted to the 01:39:15.000 --> 01:39:18.000 agency but also for research 01:39:18.000 --> 01:39:19.000 performed by FDA scientists a 01:39:19.000 --> 01:39:20.000 major part of our work is to 01:39:20.000 --> 01:39:22.000 identify and monitor women's 01:39:22.000 --> 01:39:24.000 health initiatives and emerging 01:39:24.000 --> 01:39:27.000 topics in women's health as they 01:39:27.000 --> 01:39:28.000 relate to FDA's regulatory 01:39:28.000 --> 01:39:29.000 mission. 01:39:29.000 --> 01:39:32.000 And then we serve as the 01:39:32.000 --> 01:39:33.000 principle adviser to the 01:39:33.000 --> 01:39:35.000 commissioner and to agency 01:39:35.000 --> 01:39:37.000 leadership on scientific, 01:39:37.000 --> 01:39:40.000 ethical and policy issues 01:39:40.000 --> 01:39:44.000 related to women's health and SX 01:39:44.000 --> 01:39:46.000 and 01:39:46.000 --> 01:39:47.000 sex ask gender differences in 01:39:47.000 --> 01:39:48.000 the next slide I will take a 01:39:48.000 --> 01:39:50.000 minute to talk about these terms 01:39:50.000 --> 01:39:52.000 and what they mean because you 01:39:52.000 --> 01:39:54.000 will see in the scientific 01:39:54.000 --> 01:39:58.000 literature that many people use 01:39:58.000 --> 01:39:59.000 these terms interclang BLOOE. I 01:39:59.000 --> 01:40:00.000 urge you to recognize these 01:40:00.000 --> 01:40:01.000 hangeably. I urge you to 01:40:01.000 --> 01:40:03.000 recognize these terms as 01:40:03.000 --> 01:40:07.000 as distinct and understand that 01:40:07.000 --> 01:40:13.000 sex and gender are not the same. 01:40:13.000 --> 01:40:14.000 In 2001, an institute of 01:40:14.000 --> 01:40:16.000 medicine report defines sex of 01:40:16.000 --> 01:40:18.000 sex of the classification of 01:40:18.000 --> 01:40:20.000 living things according to their 01:40:20.000 --> 01:40:25.000 reproductive organs and 01:40:25.000 --> 01:40:28.000 physiological function as signed 01:40:28.000 --> 01:40:32.000 by chromosomal. We refer to 01:40:32.000 --> 01:40:34.000 to the two sexes as male or 01:40:34.000 --> 01:40:35.000 female whereas gender is a 01:40:35.000 --> 01:40:39.000 social construct. It's 01:40:39.000 --> 01:40:40.000 influenced by an individual's 01:40:40.000 --> 01:40:42.000 environment, society and culture 01:40:42.000 --> 01:40:45.000 and is considered across a wide 01:40:45.000 --> 01:40:47.000 spectrum from masculine to femme 01:40:47.000 --> 01:40:49.000 to feminine and the so terms we 01:40:49.000 --> 01:40:51.000 use are man, woman, or something 01:40:51.000 --> 01:40:54.000 else. So sex and gender are 01:40:54.000 --> 01:40:56.000 distinct concepts which interact 01:40:56.000 --> 01:41:00.000 are interrelated. In thinking 01:41:00.000 --> 01:41:02.000 about FDA work for the most part 01:41:02.000 --> 01:41:04.000 FDA works in the biological 01:41:04.000 --> 01:41:09.000 realm. So for example when 01:41:09.000 --> 01:41:10.000 studying the farm ecokinetics of 01:41:10.000 --> 01:41:13.000 of the drug you may see 01:41:13.000 --> 01:41:15.000 may see differences by sex. 01:41:15.000 --> 01:41:16.000 But some of the work is 01:41:16.000 --> 01:41:19.000 gendered. Studies of for 01:41:19.000 --> 01:41:21.000 example where a person's diet or 01:41:21.000 --> 01:41:23.000 response to pain may differ by 01:41:23.000 --> 01:41:24.000 by gender. 01:41:24.000 --> 01:41:28.000 The biological variable is SEGZ. 01:41:28.000 --> 01:41:30.000 is sex sex matters in research 01:41:30.000 --> 01:41:32.000 because males and he will 01:41:32.000 --> 01:41:34.000 and females are not the same. 01:41:34.000 --> 01:41:37.000 There are the obvious hormone 01:41:37.000 --> 01:41:40.000 hormonal and anatomical 01:41:40.000 --> 01:41:42.000 differences and the changes with 01:41:42.000 --> 01:41:44.000 reproduction. However there may 01:41:44.000 --> 01:41:47.000 also be differences in drug 01:41:47.000 --> 01:41:49.000 metabolism that cannot be solely 01:41:49.000 --> 01:41:51.000 aattributed to hormones. Just 01:41:51.000 --> 01:41:54.000 as an example this slide shows 01:41:54.000 --> 01:41:58.000 well-established differences 01:41:58.000 --> 01:42:02.000 seen in infectious diseases. At 01:42:02.000 --> 01:42:05.000 At the extremes male and female 01:42:05.000 --> 01:42:06.000 show robust differences. 01:42:06.000 --> 01:42:10.000 Generally, females show 01:42:10.000 --> 01:42:12.000 increased susceptibility to 01:42:12.000 --> 01:42:15.000 autoinMUN disease development 01:42:15.000 --> 01:42:16.000 and males show increase in 01:42:16.000 --> 01:42:17.000 immune disease development and 01:42:17.000 --> 01:42:19.000 males show increase in 01:42:19.000 --> 01:42:23.000 susceptibility to nonproductive 01:42:23.000 --> 01:42:25.000 ma LIG NANT seas. Seeing 01:42:25.000 --> 01:42:27.000 lignancies. Seeing the SUT 01:42:27.000 --> 01:42:28.000 susceptibility as seen here in 01:42:28.000 --> 01:42:31.000 the middle. Therefore, 6 should 01:42:31.000 --> 01:42:33.000 sex should be considered when 01:42:33.000 --> 01:42:35.000 designing and analyzing studies 01:42:35.000 --> 01:42:36.000 in all areas and levels in 01:42:36.000 --> 01:42:37.000 biomedical research. That 01:42:37.000 --> 01:42:40.000 includes studies not only at the 01:42:40.000 --> 01:42:42.000 cellular level, every cell has a 01:42:42.000 --> 01:42:47.000 sex. But also for studies 01:42:47.000 --> 01:42:48.000 involving animals and humans 01:42:48.000 --> 01:42:51.000 . 01:42:51.000 --> 01:42:52.000 OWH sits within the office of 01:42:52.000 --> 01:42:53.000 of the commissioner. This 01:42:53.000 --> 01:42:55.000 allows us to work across the 01:42:55.000 --> 01:42:57.000 agency to progress the health of 01:42:57.000 --> 01:42:59.000 women by funding center 01:42:59.000 --> 01:43:02.000 research, being heavily involved 01:43:02.000 --> 01:43:04.000 in policy development, 01:43:04.000 --> 01:43:06.000 providing professional training 01:43:06.000 --> 01:43:09.000 and education to FDA scientists 01:43:09.000 --> 01:43:13.000 on the important ANS of 01:43:13.000 --> 01:43:14.000 ANS of considering sex 01:43:14.000 --> 01:43:16.000 differences and consume 01:43:16.000 --> 01:43:21.000 information for women and their 01:43:21.000 --> 01:43:37.000 families 01:43:37.000 --> 01:43:38.000 ce of considering sex 01:43:38.000 --> 01:43:39.000 differences and consume 01:43:39.000 --> 01:43:40.000 information for women and their 01:43:40.000 --> 01:43:41.000 families. 01:43:41.000 --> 01:43:42.000 Just to give you an idea of the 01:43:42.000 --> 01:43:43.000 types of research that OWH 01:43:43.000 --> 01:43:44.000 funds, on the top left you can 01:43:44.000 --> 01:43:45.000 you can see that there's a 01:43:45.000 --> 01:43:48.000 pretty good distribution of 01:43:48.000 --> 01:43:50.000 funding over a wide variety of 01:43:50.000 --> 01:43:52.000 research topics and fields. 01:43:52.000 --> 01:43:54.000 In terms of research focus about 01:43:54.000 --> 01:43:56.000 focus bottom right, even though 01:43:56.000 --> 01:43:59.000 we have no quotas in terms of 01:43:59.000 --> 01:44:02.000 the research we fund, it turns 01:44:02.000 --> 01:44:06.000 out that there's a pretty much 01:44:06.000 --> 01:44:09.000 equal distribution of funding 01:44:09.000 --> 01:44:12.000 among projects, lackation, or 01:44:12.000 --> 01:44:14.000 conditions solely affecting 01:44:14.000 --> 01:44:17.000 women. The goal is to make an 01:44:17.000 --> 01:44:20.000 impact of FDA work. This slide 01:44:20.000 --> 01:44:23.000 shows research funded through 01:44:23.000 --> 01:44:27.000 our IM program but I assure you 01:44:27.000 --> 01:44:30.000 that we do also fund 01:44:30.000 --> 01:44:31.000 BAAs. 01:44:31.000 --> 01:44:34.000 In the last four years we have 01:44:34.000 --> 01:44:36.000 we have funded seven BAAs the 01:44:36.000 --> 01:44:39.000 two web MD studies you see here 01:44:39.000 --> 01:44:40.000 are surveys. Behaviors related 01:44:40.000 --> 01:44:43.000 to medication, safety, and use 01:44:43.000 --> 01:44:45.000 during BREG man sea and 01:44:45.000 --> 01:44:47.000 pregnancy and determinants of 01:44:47.000 --> 01:44:50.000 hormone replacement therapy 01:44:50.000 --> 01:44:52.000 knowledge and current HRT use. 01:44:52.000 --> 01:44:59.000 The third study is a 01:44:59.000 --> 01:45:03.000 biomolecular research focused 01:45:03.000 --> 01:45:04.000 on the BCRE substrates into 01:45:04.000 --> 01:45:07.000 human milk we are willing to 01:45:07.000 --> 01:45:09.000 fund all kinds of research from 01:45:09.000 --> 01:45:11.000 social behavioral science to 01:45:11.000 --> 01:45:13.000 bench science. 01:45:13.000 --> 01:45:15.000 Our research funding decisions 01:45:15.000 --> 01:45:17.000 are guided by our women's health 01:45:17.000 --> 01:45:21.000 research road map, available on 01:45:21.000 --> 01:45:22.000 on the OWH website. This first 01:45:22.000 --> 01:45:25.000 of its kind road map 01:45:25.000 --> 01:45:26.000 incorporated across agency input 01:45:26.000 --> 01:45:29.000 to help create strategic 01:45:29.000 --> 01:45:32.000 direction for women -- women's 01:45:32.000 --> 01:45:34.000 health for the agency. Its 01:45:34.000 --> 01:45:37.000 purpose was to develop a 01:45:37.000 --> 01:45:39.000 strategy for determining the 01:45:39.000 --> 01:45:43.000 future of OWH research this road 01:45:43.000 --> 01:45:45.000 map is based on data from 01:45:45.000 --> 01:45:46.000 analysis from our research 01:45:46.000 --> 01:45:48.000 portfolio. 01:45:48.000 --> 01:45:52.000 In the road map, we identify 01:45:52.000 --> 01:45:54.000 7 priority areas which you can 01:45:54.000 --> 01:45:56.000 see here. Priorities are 01:45:56.000 --> 01:45:58.000 numbered but not in a specific 01:45:58.000 --> 01:46:00.000 order. No priority area is more 01:46:00.000 --> 01:46:03.000 important than any of the others 01:46:03.000 --> 01:46:04.000 . 01:46:04.000 --> 01:46:07.000 Here I am showing a snapshot of 01:46:07.000 --> 01:46:10.000 the areas of research OWH has 01:46:10.000 --> 01:46:12.000 FUPDed over the last ten years. 01:46:12.000 --> 01:46:14.000 funded over the last ten years. 01:46:14.000 --> 01:46:17.000 Categories are not mutually EKS 01:46:17.000 --> 01:46:19.000 collusive so they can be tagged 01:46:19.000 --> 01:46:20.000 exclusive so they can be tagged 01:46:20.000 --> 01:46:23.000 by multiple research areas most 01:46:23.000 --> 01:46:26.000 include cardiovascular, medical 01:46:26.000 --> 01:46:27.000 device OBGYN and oncology. 01:46:27.000 --> 01:46:31.000 There are a small number of 01:46:31.000 --> 01:46:33.000 projects in some research areas 01:46:33.000 --> 01:46:36.000 and there are key research areas 01:46:36.000 --> 01:46:40.000 including autoimmune diseases 01:46:40.000 --> 01:46:42.000 cosmetics dermatology even 01:46:42.000 --> 01:46:46.000 even these categories that look 01:46:46.000 --> 01:46:48.000 like they have a lot, need more 01:46:48.000 --> 01:46:53.000 research, such as end MOOE trio 01:46:53.000 --> 01:46:55.000 sis, and fie BROIDZ there are 01:46:55.000 --> 01:46:57.000 ometria sis, and fie BROIDZ 01:46:57.000 --> 01:46:59.000 there are we looking for more 01:46:59.000 --> 01:47:03.000 funding for these methods as 01:47:03.000 --> 01:47:05.000 they pertain to women's health. 01:47:05.000 --> 01:47:07.000 We will consider projects which 01:47:07.000 --> 01:47:11.000 involve key women's issues 01:47:11.000 --> 01:47:13.000 particularly those that have not 01:47:13.000 --> 01:47:14.000 received recent funding align 01:47:14.000 --> 01:47:19.000 with the road map priorities, 01:47:19.000 --> 01:47:23.000 include cross-cutting and 01:47:23.000 --> 01:47:26.000 mutt by disciplinary 01:47:26.000 --> 01:47:31.000 women's health priority areas 01:47:31.000 --> 01:47:36.000 across the centers. 01:47:36.000 --> 01:47:39.000 01:47:39.000 --> 01:47:43.000 Thank you so much for your time. 01:47:43.000 --> 01:47:48.000 time and attention 01:47:48.000 --> 01:47:49.000 . 01:47:49.000 --> 01:47:50.000 >>DR. KINNERA CHADA: Thank you. 01:47:50.000 --> 01:47:56.000 Do we have any questions for 01:47:56.000 --> 01:47:57.000 Dr. Obidi from OWH? She is 01:47:57.000 --> 01:48:02.000 present and she will be able to 01:48:02.000 --> 01:48:24.000 answer any questions 01:48:24.000 --> 01:48:27.000 . Thank you, once again, for 01:48:27.000 --> 01:48:29.000 for all of the presenters from 01:48:29.000 --> 01:48:33.000 centers and offices who have 01:48:33.000 --> 01:48:36.000 discussed their research 01:48:36.000 --> 01:48:37.000 priorities for research 01:48:37.000 --> 01:48:38.000 applications. So for the 01:48:38.000 --> 01:48:41.000 attendees, if you have any 01:48:41.000 --> 01:48:43.000 questions please feel free to 01:48:43.000 --> 01:48:48.000 post them in the Q & A session. 01:48:48.000 --> 01:48:52.000 Okay, Dr. Obi DIESHGS 01:48:52.000 --> 01:48:59.000 Obidi, there's a question 01:48:59.000 --> 01:49:01.000 . Dr. 01:49:01.000 --> 01:49:02.000 Obidi? 01:49:02.000 --> 01:49:03.000 >>DR. JOYCE OBIDI: Yes I'm 01:49:03.000 --> 01:49:07.000 sorry I'm here. The question 01:49:07.000 --> 01:49:09.000 is: Is there any interest in 01:49:09.000 --> 01:49:11.000 contraception in the use and 01:49:11.000 --> 01:49:15.000 discontinuation? 01:49:15.000 --> 01:49:20.000 Um, so I would 01:49:20.000 --> 01:49:21.000 say yes. If it'll aligns with 01:49:21.000 --> 01:49:24.000 our priority areas. We would 01:49:24.000 --> 01:49:26.000 have to see what the study is. 01:49:26.000 --> 01:49:29.000 And then go from there and see 01:49:29.000 --> 01:49:30.000 if it -- it'll go through a peer 01:49:30.000 --> 01:49:36.000 review process and we would 01:49:36.000 --> 01:49:41.000 definitely seek advice from 01:49:41.000 --> 01:49:43.000 other people within 01:49:43.000 --> 01:49:48.000 CDER to make sure that it 01:49:48.000 --> 01:49:50.000 aligns with our priorities 01:49:50.000 --> 01:49:51.000 . 01:49:51.000 --> 01:49:55.000 >>DR. KINNERA CHADA: Thank you, 01:49:55.000 --> 01:49:58.000 Dr. Obidi. So that you see 01:49:58.000 --> 01:50:00.000 So that was the last present 01:50:00.000 --> 01:50:02.000 presentation from the centers 01:50:02.000 --> 01:50:05.000 and offices. The next two 01:50:05.000 --> 01:50:10.000 presentations would be from DBA 01:50:10.000 --> 01:50:14.000 A and ORES team. So hi, 01:50:14.000 --> 01:50:16.000 once again. This is Kinnera 01:50:16.000 --> 01:50:19.000 Chada I am the program leader 01:50:19.000 --> 01:50:20.000 for the broad agency 01:50:20.000 --> 01:50:24.000 announcement I would like to 01:50:24.000 --> 01:50:26.000 introduce my team members within 01:50:26.000 --> 01:50:28.000 office of regulatory and 01:50:28.000 --> 01:50:34.000 emerging sciences. We have Ms. 01:50:34.000 --> 01:50:38.000 Jessica and Mr. Lewis Lee we 01:50:38.000 --> 01:50:43.000 work very closely with the OAGS, 01:50:43.000 --> 01:50:44.000 Mr. Wine STOOEN. And we 01:50:44.000 --> 01:50:46.000 einstein. And we basically work 01:50:46.000 --> 01:50:50.000 on preparing the announcement is 01:50:50.000 --> 01:50:54.000 that has been posted. And we do 01:50:54.000 --> 01:50:59.000 accept the applications and also 01:50:59.000 --> 01:51:01.000 process the... [distortion] to 01:51:01.000 --> 01:51:06.000 to the applicants along with 01:51:06.000 --> 01:51:07.000 the teams located 01:51:07.000 --> 01:51:11.000 in OAGS. 01:51:11.000 --> 01:51:14.000 So next slide, please 01:51:14.000 --> 01:51:19.000 . In my presentation today, I 01:51:19.000 --> 01:51:23.000 would be presenting 01:51:23.000 --> 01:51:27.000 the -- provide you with a 01:51:27.000 --> 01:51:28.000 historical summary by taking... 01:51:28.000 --> 01:51:30.000 BAA applications outcomes. I 01:51:30.000 --> 01:51:35.000 I will be discussing 01:51:35.000 --> 01:51:36.000 information regarding optional 01:51:36.000 --> 01:51:40.000 early concept papers 01:51:40.000 --> 01:51:42.000 amendments, dos and do notes of 01:51:42.000 --> 01:51:44.000 FY25 applications. I will be 01:51:44.000 --> 01:51:45.000 providing you some take-home 01:51:45.000 --> 01:51:49.000 home information that would 01:51:49.000 --> 01:51:52.000 include due dates as well as 01:51:52.000 --> 01:51:54.000 timelines expected. And also 01:51:54.000 --> 01:51:59.000 discuss some frequently-asked 01:51:59.000 --> 01:52:00.000 questions. Next slide, please 01:52:00.000 --> 01:52:05.000 . 01:52:05.000 --> 01:52:08.000 So FDA has been using 01:52:08.000 --> 01:52:10.000 contract mechanism to advance 01:52:10.000 --> 01:52:14.000 regulatory research areas. Our 01:52:14.000 --> 01:52:19.000 Our public page is posted 01:52:19.000 --> 01:52:23.000 in the chat window. Next 01:52:23.000 --> 01:52:27.000 . 01:52:27.000 --> 01:52:29.000 Please note that BAAs can only 01:52:29.000 --> 01:52:30.000 be issued for the procurement of 01:52:30.000 --> 01:52:32.000 research and development. And 01:52:32.000 --> 01:52:34.000 And the definitions for 01:52:34.000 --> 01:52:36.000 research and development for 01:52:36.000 --> 01:52:38.000 basic research applied research, 01:52:38.000 --> 01:52:40.000 as well as development has been 01:52:40.000 --> 01:52:42.000 have been defined in the 01:52:42.000 --> 01:52:43.000 federal acquisition regulations 01:52:43.000 --> 01:52:46.000 and also posted in the 01:52:46.000 --> 01:52:48.000 announcement. You could find a 01:52:48.000 --> 01:52:49.000 detailed discussion on these 01:52:49.000 --> 01:52:54.000 research and development 01:52:54.000 --> 01:52:59.000 categories under 01:52:59.000 --> 01:53:01.000 FAR2.101. So 01:53:01.000 --> 01:53:05.000 the table here shows the 01:53:05.000 --> 01:53:08.000 historical data for BAA program 01:53:08.000 --> 01:53:11.000 and the first column here is 01:53:11.000 --> 01:53:13.000 related to the fiscal year. 01:53:13.000 --> 01:53:16.000 PREFSly mentioned that this was 01:53:16.000 --> 01:53:17.000 initiated in 2012. We are 01:53:17.000 --> 01:53:18.000 reviously mentioned that this 01:53:18.000 --> 01:53:19.000 was initiated in 2012. We are 01:53:19.000 --> 01:53:22.000 showing decades of data this 01:53:22.000 --> 01:53:25.000 relates to the fiscal year which 01:53:25.000 --> 01:53:27.000 starts October 1st and ends 01:53:27.000 --> 01:53:28.000 September 30th of the next year. 01:53:28.000 --> 01:53:30.000 This shows the applications 01:53:30.000 --> 01:53:33.000 received this is the charts 01:53:33.000 --> 01:53:34.000 previously or the concept papers 01:53:34.000 --> 01:53:36.000 and you would be seeing that 01:53:36.000 --> 01:53:37.000 that there has been a 01:53:37.000 --> 01:53:39.000 significant increase in the 01:53:39.000 --> 01:53:41.000 number of concept papers or 01:53:41.000 --> 01:53:44.000 applications that we have been 01:53:44.000 --> 01:53:45.000 receiving the third column 01:53:45.000 --> 01:53:47.000 showings the number of awarded 01:53:47.000 --> 01:53:51.000 projects and the next column 01:53:51.000 --> 01:53:55.000 shows the total dollars awarded 01:53:55.000 --> 01:53:56.000 for all the contracts listed in 01:53:56.000 --> 01:53:58.000 the chart here. 01:53:58.000 --> 01:54:00.000 In the past BAAs we had requests 01:54:00.000 --> 01:54:04.000 regarding the minimum and the 01:54:04.000 --> 01:54:05.000 the maximum amount for the 01:54:05.000 --> 01:54:07.000 contracts funded within that 01:54:07.000 --> 01:54:09.000 year. So the last two columns 01:54:09.000 --> 01:54:11.000 here shows the minimum and 01:54:11.000 --> 01:54:13.000 maximum. So for example for 01:54:13.000 --> 01:54:17.000 2024 fiscal year there were 24 01:54:17.000 --> 01:54:21.000 projects which totalled 01:54:21.000 --> 01:54:28.000 24 -- 01:54:28.000 --> 01:54:29.000 2024, 5 million and then 01:54:29.000 --> 01:54:32.000 $243,000 and the maximum was 01:54:32.000 --> 01:54:33.000 about $3 million. 01:54:33.000 --> 01:54:36.000 . 01:54:36.000 --> 01:54:38.000 Next slide, please. 01:54:38.000 --> 01:54:41.000 So I wanted to go over the 01:54:41.000 --> 01:54:43.000 application process and the 01:54:43.000 --> 01:54:44.000 review process for BAA 01:54:44.000 --> 01:54:47.000 everything starts with 01:54:47.000 --> 01:54:51.000 submission of concept paper and 01:54:51.000 --> 01:54:53.000 proposal. Once we receive the 01:54:53.000 --> 01:54:55.000 concept paper and the full 01:54:55.000 --> 01:54:59.000 proposal, which the details have 01:54:59.000 --> 01:55:01.000 been described in part 3 of the 01:55:01.000 --> 01:55:05.000 announcement, the program 01:55:05.000 --> 01:55:07.000 leaders, the offices of the FDA 01:55:07.000 --> 01:55:08.000 centers and offices, receive the 01:55:08.000 --> 01:55:10.000 the concept paper which is a 01:55:10.000 --> 01:55:12.000 three-page information that the 01:55:12.000 --> 01:55:15.000 applicant submits. High HCH 01:55:15.000 --> 01:55:17.000 level evaluation is done based 01:55:17.000 --> 01:55:21.000 on the review of the concept 01:55:21.000 --> 01:55:23.000 paper. Next 01:55:23.000 --> 01:55:24.000 research level evaluation is 01:55:24.000 --> 01:55:25.000 done based on the review of the 01:55:25.000 --> 01:55:26.000 concept paper. Next. If a 01:55:26.000 --> 01:55:29.000 review should be initiated for 01:55:29.000 --> 01:55:30.000 for the full proposal or if a 01:55:30.000 --> 01:55:31.000 notification should be sent to 01:55:31.000 --> 01:55:33.000 the applicant saying that the 01:55:33.000 --> 01:55:36.000 full proposal will not be 01:55:36.000 --> 01:55:40.000 reviewed. If the -- if there is 01:55:40.000 --> 01:55:41.000 interest from the program office 01:55:41.000 --> 01:55:44.000 to initiate review of the full 01:55:44.000 --> 01:55:45.000 RO pose ZAL, we move forward and 01:55:45.000 --> 01:55:48.000 proposal, we move forward and 01:55:48.000 --> 01:55:51.000 there is a a technical panel 01:55:51.000 --> 01:55:53.000 initiated which comprises with 01:55:53.000 --> 01:55:54.000 three or more subject matters 01:55:54.000 --> 01:55:57.000 experts in the area. They do 01:55:57.000 --> 01:55:58.000 the review of the full proposal 01:55:58.000 --> 01:56:01.000 along with the concept paper and 01:56:01.000 --> 01:56:04.000 BAEN based on the review, one of 01:56:04.000 --> 01:56:06.000 these three outcomes happens. 01:56:06.000 --> 01:56:08.000 Next animation, please. It -- 01:56:08.000 --> 01:56:10.000 if the technical panel 01:56:10.000 --> 01:56:12.000 recommends that additional 01:56:12.000 --> 01:56:14.000 revisions are needed then in 01:56:14.000 --> 01:56:16.000 that case it moves forward with 01:56:16.000 --> 01:56:19.000 the stage two review where the 01:56:19.000 --> 01:56:24.000 applicant is sent a letter to 01:56:24.000 --> 01:56:25.000 submit a revised proposal. If 01:56:25.000 --> 01:56:30.000 the panel recommends that there 01:56:30.000 --> 01:56:34.000 are some 01:56:34.000 --> 01:56:36.000 some limitations.... applicant 01:56:36.000 --> 01:56:39.000 will be receiving feedback 01:56:39.000 --> 01:56:41.000 as part of the letter. The 01:56:41.000 --> 01:56:43.000 third option that would happen 01:56:43.000 --> 01:56:46.000 after the stage 1 review is if 01:56:46.000 --> 01:56:48.000 if the panel recommends a 01:56:48.000 --> 01:56:49.000 reward and funds are available 01:56:49.000 --> 01:56:52.000 it would move forward. What 01:56:52.000 --> 01:56:56.000 happens if the panel recommend 01:56:56.000 --> 01:56:58.000 stage 2 or revisions? We so sea 01:56:58.000 --> 01:57:00.000 the same process repeated where 01:57:00.000 --> 01:57:04.000 it either moves forward... aft 01:57:04.000 --> 01:57:05.000 stage 2 panel meeting which is 01:57:05.000 --> 01:57:08.000 from the same subject matters 01:57:08.000 --> 01:57:10.000 experts that have reviewed the 01:57:10.000 --> 01:57:14.000 the stage one of the propose as 01:57:14.000 --> 01:57:16.000 of the proposal... recommends 01:57:16.000 --> 01:57:17.000 that there are still any 01:57:17.000 --> 01:57:21.000 limitations then they would 01:57:21.000 --> 01:57:22.000 receive a regret notification. 01:57:22.000 --> 01:57:24.000 . 01:57:24.000 --> 01:57:25.000 . 01:57:25.000 --> 01:57:28.000 It could also be possible that 01:57:28.000 --> 01:57:29.000 sometimes the applicants might 01:57:29.000 --> 01:57:33.000 receive notification without 01:57:33.000 --> 01:57:35.000 having. . . Any... proposal. 01:57:35.000 --> 01:57:39.000 Next slide, please. 01:57:39.000 --> 01:57:43.000 So taking a dive into the FY24B 01:57:43.000 --> 01:57:47.000 AA applications and the outcome. 01:57:47.000 --> 01:57:49.000 We received 281 concept papers 01:57:49.000 --> 01:57:51.000 and you will see about ten 01:57:51.000 --> 01:57:53.000 percent of these have been 01:57:53.000 --> 01:57:54.000 awarded and then we have five 01:57:54.000 --> 01:57:57.000 percent of them pending. What 01:57:57.000 --> 01:57:58.000 does pending status mean? It is 01:57:58.000 --> 01:58:00.000 they have been reviewed they 01:58:00.000 --> 01:58:02.000 have gone through either stage 1 01:58:02.000 --> 01:58:06.000 or stage 2 review process. And 01:58:06.000 --> 01:58:09.000 the panel has recommended award. 01:58:09.000 --> 01:58:11.000 But due to lack of funds they 01:58:11.000 --> 01:58:15.000 are still not been awarded. 01:58:15.000 --> 01:58:17.000 Then we have an... lack of funds 01:58:17.000 --> 01:58:21.000 which is based on high-level 01:58:21.000 --> 01:58:24.000 review of 01:58:24.000 --> 01:58:26.000 the concept papers and then 01:58:26.000 --> 01:58:28.000 unaligned priorities. These 01:58:28.000 --> 01:58:30.000 were rejected or did not move 01:58:30.000 --> 01:58:32.000 forward after the concept 01:58:32.000 --> 01:58:34.000 review, because the program 01:58:34.000 --> 01:58:36.000 leaders felt that the priorities 01:58:36.000 --> 01:58:38.000 defined in the objectives or 01:58:38.000 --> 01:58:40.000 aims did not align with FDA's 01:58:40.000 --> 01:58:44.000 priorities and then we have 01:58:44.000 --> 01:58:46.000 another at category which shows 01:58:46.000 --> 01:58:49.000 lack of funds this is basically 01:58:49.000 --> 01:58:50.000 what happens after the panel is 01:58:50.000 --> 01:58:54.000 reviewed. Due to lack of funds 01:58:54.000 --> 01:58:55.000 these proposals were not awarded 01:58:55.000 --> 01:58:57.000 and then the final category 01:58:57.000 --> 01:58:59.000 where we have award not 01:58:59.000 --> 01:59:01.000 recommended after panel review 01:59:01.000 --> 01:59:05.000 this could be either due to 01:59:05.000 --> 01:59:06.000 limitations or other feedback 01:59:06.000 --> 01:59:07.000 which has been provided to the 01:59:07.000 --> 01:59:12.000 applicants. 01:59:12.000 --> 01:59:13.000 Next, please. So just wanted 01:59:13.000 --> 01:59:15.000 to touch base on the 01:59:15.000 --> 01:59:20.000 communication side of things 01:59:20.000 --> 01:59:22.000 that were related to FY24BAA 01:59:22.000 --> 01:59:26.000 announcement. Acknowledgment of 01:59:26.000 --> 01:59:29.000 of receipt of application was 01:59:29.000 --> 01:59:33.000 received within one week 01:59:33.000 --> 01:59:38.000 applicants were informed 01:59:38.000 --> 01:59:42.000 . Irrespective of 01:59:42.000 --> 01:59:45.000 the category. Of what would be 01:59:45.000 --> 01:59:48.000 happening in FY25. To receive 01:59:48.000 --> 01:59:52.000 a... by December 6th if there 01:59:52.000 --> 02:00:01.000 would be awarded 02:00:01.000 --> 02:00:03.000 so I wanted to discuss and 02:00:03.000 --> 02:00:06.000 and provide you with some more 02:00:06.000 --> 02:00:10.000 information regarding the 02:00:10.000 --> 02:00:12.000 optional concept papers the due 02:00:12.000 --> 02:00:14.000 date was last Friday. And 02:00:14.000 --> 02:00:17.000 basically what optional early 02:00:17.000 --> 02:00:21.000 concept papers is, it is a step 02:00:21.000 --> 02:00:26.000 within the BAA process where 02:00:26.000 --> 02:00:28.000 applicants might see 02:00:28.000 --> 02:00:30.000 FDA interest or lack of 02:00:30.000 --> 02:00:31.000 interest in stage 1. Please 02:00:31.000 --> 02:00:36.000 note as part of the concept 02:00:36.000 --> 02:00:38.000 paper, it's optional. FDA 02:00:38.000 --> 02:00:40.000 program offices are not 02:00:40.000 --> 02:00:42.000 obligated to provide feedback 02:00:42.000 --> 02:00:44.000 for the early concept paper 02:00:44.000 --> 02:00:47.000 review. Next animation, please. 02:00:47.000 --> 02:00:49.000 Please note that submission is 02:00:49.000 --> 02:00:54.000 not needed as a qualification, 02:00:54.000 --> 02:00:55.000 consideration of a stage 1 for 02:00:55.000 --> 02:01:00.000 FY25 applications if you have 02:01:00.000 --> 02:01:02.000 not submitted last Friday 02:01:02.000 --> 02:01:06.000 you are -- stage 1 application 02:01:06.000 --> 02:01:07.000 or before February 24. If you 02:01:07.000 --> 02:01:11.000 have submitted an early concept 02:01:11.000 --> 02:01:12.000 paper if you have 02:01:12.000 --> 02:01:14.000 received your application you 02:01:14.000 --> 02:01:15.000 should have received a 02:01:15.000 --> 02:01:19.000 notification of either 02:01:19.000 --> 02:01:23.000 complete, incomplete or late 02:01:23.000 --> 02:01:24.000 application. For any of the 02:01:24.000 --> 02:01:27.000 early concept papers we will be 02:01:27.000 --> 02:01:29.000 doing a high-level evaluation. 02:01:29.000 --> 02:01:31.000 If there is interest in the 02:01:31.000 --> 02:01:32.000 concept paper, then they 02:01:32.000 --> 02:01:35.000 would.... make a recommendation 02:01:35.000 --> 02:01:37.000 for submitting a stage one 02:01:37.000 --> 02:01:42.000 package in February. And if the 02:01:42.000 --> 02:01:44.000 applicant... recommendation they 02:01:44.000 --> 02:01:46.000 can submit proposal which 02:01:46.000 --> 02:01:50.000 comprises of the concept paper 02:01:50.000 --> 02:01:52.000 as well as the full proposal 02:01:52.000 --> 02:01:55.000 on or before February 24. 02:01:55.000 --> 02:01:57.000 Once we receive the application 02:01:57.000 --> 02:01:58.000 a review will be initiated 02:01:58.000 --> 02:02:01.000 provided the application is 02:02:01.000 --> 02:02:04.000 is complete. Now, if you have 02:02:04.000 --> 02:02:05.000 submitted an early concept paper 02:02:05.000 --> 02:02:08.000 and received a recommendation of 02:02:08.000 --> 02:02:11.000 not submit stage 1 package in 02:02:11.000 --> 02:02:15.000 February what are your options? 02:02:15.000 --> 02:02:16.000 Then you could either follow 02:02:16.000 --> 02:02:20.000 FDA's recommendation by SMID 02:02:20.000 --> 02:02:23.000 by submitting a... 02:02:23.000 --> 02:02:24.000 you will be able to revise your 02:02:24.000 --> 02:02:29.000 concept paper as well as the 02:02:29.000 --> 02:02:32.000 full proposal based 02:02:32.000 --> 02:02:35.000 on the... this will be created 02:02:35.000 --> 02:02:39.000 as a new application if: Was 02:02:39.000 --> 02:02:43.000 provided to you. Recommend to 02:02:43.000 --> 02:02:56.000 submit was provided to you, 02:02:56.000 --> 02:02:58.000 then next slide, please. So we 02:02:58.000 --> 02:03:01.000 have received 209 optional early 02:03:01.000 --> 02:03:04.000 concept papers. Data... is 02:03:04.000 --> 02:03:07.000 complete. And communications or 02:03:07.000 --> 02:03:09.000 notifications regarding FDA's 02:03:09.000 --> 02:03:11.000 FDA's recommendation with 02:03:11.000 --> 02:03:15.000 optional feedback if available 02:03:15.000 --> 02:03:23.000 would be provided 02:03:23.000 --> 02:03:26.000 December 16th, 2024. And 02:03:26.000 --> 02:03:31.000 then... 401 in charge 3. Next 02:03:31.000 --> 02:03:33.000 slide, please. We ALS have been 02:03:33.000 --> 02:03:35.000 We also have been posting 02:03:35.000 --> 02:03:37.000 amendments to BAA since last 02:03:37.000 --> 02:03:39.000 year. The purpose is to 02:03:39.000 --> 02:03:41.000 to communicate updated funding 02:03:41.000 --> 02:03:43.000 priorities. Potential dates for 02:03:43.000 --> 02:03:44.000 posting amendments have been 02:03:44.000 --> 02:03:47.000 provided in the announcements 02:03:47.000 --> 02:03:49.000 and also listed here. We could 02:03:49.000 --> 02:03:56.000 We could be having an amendment 02:03:56.000 --> 02:03:58.000 tomorrow. Any of the... may be 02:03:58.000 --> 02:03:59.000 be highlighted in the same 02:03:59.000 --> 02:04:02.000 color and communicated with a 02:04:02.000 --> 02:04:06.000 hashtag. Please note that last 02:04:06.000 --> 02:04:09.000 day for FDA for... 02:04:09.000 --> 02:04:10.000 solicitation is January 17th of 02:04:10.000 --> 02:04:12.000 January 17th of next year. 02:04:12.000 --> 02:04:15.000 Just as a heads up, we would be 02:04:15.000 --> 02:04:16.000 we would be posting amendments 02:04:16.000 --> 02:04:19.000 tomorrow. And the amendments 02:04:19.000 --> 02:04:23.000 will include added scope that 02:04:23.000 --> 02:04:27.000 was presented 02:04:27.000 --> 02:04:31.000 by Ms. Sara Sklenka 02:04:31.000 --> 02:04:37.000 ... the areas. 02:04:37.000 --> 02:04:42.000 And also [AUDIO DISTORTION] 02:04:42.000 --> 02:04:45.000 . 02:04:45.000 --> 02:04:47.000 Table one that shows a... 02:04:47.000 --> 02:04:51.000 designs framework with the... 02:04:51.000 --> 02:04:54.000 various [AUDIO DISTORTION] 02:04:54.000 --> 02:04:57.000 demographics has also been 02:04:57.000 --> 02:05:04.000 updated... medicines research... 02:05:04.000 --> 02:05:06.000 [AUDIO DISTORTION]. 02:05:06.000 --> 02:05:07.000 >> I'm getting a bit of 02:05:07.000 --> 02:05:11.000 distortion from your audio. 02:05:11.000 --> 02:05:12.000 . Just to make you aware. 02:05:12.000 --> 02:05:13.000 02:05:13.000 --> 02:05:16.000 >>DR. KINNERA CHADA: Okay, 02:05:16.000 --> 02:05:17.000 thank you for letting me know. 02:05:17.000 --> 02:05:18.000 >> Yeah. 02:05:18.000 --> 02:05:20.000 >>DR. KINNERA CHADA: Next 02:05:20.000 --> 02:05:21.000 slide, please. Is it better 02:05:21.000 --> 02:05:23.000 now? 02:05:23.000 --> 02:05:24.000 >> Yeah. Yeah. As you progress 02:05:24.000 --> 02:05:26.000 it kind of starts, but keep 02:05:26.000 --> 02:05:27.000 going. Sorry. 02:05:27.000 --> 02:05:34.000 >>DR. KINNERA CHADA: Okay. 02:05:34.000 --> 02:05:37.000 Thank you. So these are some of 02:05:37.000 --> 02:05:40.000 some of the dos and don'ts for 02:05:40.000 --> 02:05:41.000 for the FY25 application 02:05:41.000 --> 02:05:43.000 process. Please do submit all 02:05:43.000 --> 02:05:44.000 required documents for the 02:05:44.000 --> 02:05:46.000 package which includes 02:05:46.000 --> 02:05:47.000 checklist, concept paper, full 02:05:47.000 --> 02:05:49.000 proposal. 02:05:49.000 --> 02:05:52.000 Do not submit applications 02:05:52.000 --> 02:05:55.000 without either a full proposal, 02:05:55.000 --> 02:05:58.000 cost proposal or statement. 02:05:58.000 --> 02:06:00.000 Regarding the format for the 02:06:00.000 --> 02:06:03.000 documents, required documents 02:06:03.000 --> 02:06:06.000 they need to be in PDF only. It 02:06:06.000 --> 02:06:09.000 is only to submit Word or excel 02:06:09.000 --> 02:06:13.000 files for the documents that are 02:06:13.000 --> 02:06:16.000 not required or appendixes 02:06:16.000 --> 02:06:17.000 . But for the required 02:06:17.000 --> 02:06:20.000 documents please make sure only 02:06:20.000 --> 02:06:21.000 submit PDF documents. 02:06:21.000 --> 02:06:22.000 Contact information for any 02:06:22.000 --> 02:06:26.000 questions or clarifications 02:06:26.000 --> 02:06:30.000 related to the -- to the FDA, 02:06:30.000 --> 02:06:35.000 BAA program is to contact FDA 02:06:35.000 --> 02:06:37.000 BAA [AUDIO DISTORTION] 02:06:37.000 --> 02:06:40.000 please do not contact any of 02:06:40.000 --> 02:06:42.000 of the staff within FDA. 02:06:42.000 --> 02:06:43.000 Please do complete all fields of 02:06:43.000 --> 02:06:47.000 of the concept paper which 02:06:47.000 --> 02:06:51.000 includes the cover table and the 02:06:51.000 --> 02:06:52.000 overview, given as attachment 4 02:06:52.000 --> 02:06:56.000 of the attachment and also the 02:06:56.000 --> 02:06:58.000 full proposal, attachment 02:06:58.000 --> 02:07:03.000 5, volume 1 technical propose 02:07:03.000 --> 02:07:05.000 proposal 02:07:05.000 --> 02:07:07.000 please do not exceed page 02:07:07.000 --> 02:07:10.000 limits of these required 02:07:10.000 --> 02:07:12.000 documents. Next slide, please. 02:07:12.000 --> 02:07:14.000 So this is some of the take-home 02:07:14.000 --> 02:07:15.000 information this includes the 02:07:15.000 --> 02:07:17.000 due dates as well as the 02:07:17.000 --> 02:07:20.000 as well as the communication 02:07:20.000 --> 02:07:23.000 timelines. So December 16th, 02:07:23.000 --> 02:07:24.000 2024, you will be receiving FD 02:07:24.000 --> 02:07:28.000 a. Recommendation notification 02:07:28.000 --> 02:07:29.000 for early concept papers this 02:07:29.000 --> 02:07:32.000 this is only if you have 02:07:32.000 --> 02:07:35.000 submitted an early concept 02:07:35.000 --> 02:07:37.000 paper. January 17th, 2025, is 02:07:37.000 --> 02:07:40.000 the last day for FDA to post any 02:07:40.000 --> 02:07:45.000 amendments to the FY25BA 02:07:45.000 --> 02:07:48.000 solicitation. February 24, 02:07:48.000 --> 02:07:49.000 February 24, 2025, is the due 02:07:49.000 --> 02:07:52.000 date for the application to be 02:07:52.000 --> 02:07:56.000 considered for FY25 funding 02:07:56.000 --> 02:07:58.000 consideration. 02:07:58.000 --> 02:08:02.000 The statement package will once 02:08:02.000 --> 02:08:06.000 again include concept and the 02:08:06.000 --> 02:08:08.000 full proposal. March 6th is the 02:08:08.000 --> 02:08:11.000 application [AUDIO DISTORTION] 02:08:11.000 --> 02:08:13.000 that is about one week from the 02:08:13.000 --> 02:08:15.000 due date and this is when you 02:08:15.000 --> 02:08:17.000 would be receiving a 02:08:17.000 --> 02:08:19.000 notification saying that if your 02:08:19.000 --> 02:08:23.000 your application is complete, 02:08:23.000 --> 02:08:25.000 incomplete or late. April 02:08:25.000 --> 02:08:26.000 April 7th, this has been 02:08:26.000 --> 02:08:30.000 introduced this year where we 02:08:30.000 --> 02:08:34.000 are hoping to inform MRIKTS to 02:08:34.000 --> 02:08:36.000 applicants to send their regret 02:08:36.000 --> 02:08:38.000 notification the concept paper 02:08:38.000 --> 02:08:40.000 has been reviewed and is not 02:08:40.000 --> 02:08:41.000 moving forward for the stage 1 02:08:41.000 --> 02:08:44.000 application based on the concept 02:08:44.000 --> 02:08:47.000 paper review. Applicants would 02:08:47.000 --> 02:08:48.000 be informed April 7th to let 02:08:48.000 --> 02:08:50.000 them know that their application 02:08:50.000 --> 02:08:53.000 would not be moving forward for 02:08:53.000 --> 02:08:55.000 stage 1 review. 02:08:55.000 --> 02:08:58.000 If your application has moved 02:08:58.000 --> 02:09:03.000 forward for stage 1 review and 02:09:03.000 --> 02:09:07.000 stage 2 was requested, 02:09:07.000 --> 02:09:10.000 then 14 calendar 02:09:10.000 --> 02:09:13.000 days to submit proposal and the 02:09:13.000 --> 02:09:18.000 clock starts after you receive 02:09:18.000 --> 02:09:22.000 revision from FDA any decisions 02:09:22.000 --> 02:09:25.000 [AUDIO DISTORTION] outcomes 02:09:25.000 --> 02:09:27.000 already informed we received by 02:09:27.000 --> 02:09:31.000 by September 30th, '25. This 02:09:31.000 --> 02:09:33.000 by September 30th, '25. Stage 02:09:33.000 --> 02:09:36.000 ... lack of funds or any regret 02:09:36.000 --> 02:09:39.000 notifications due to limitations 02:09:39.000 --> 02:09:42.000 that have been identified by the 02:09:42.000 --> 02:09:44.000 by the panelists. 02:09:44.000 --> 02:09:50.000 February 25th to September 28th 02:09:50.000 --> 02:09:52.000 is the time period where the 02:09:52.000 --> 02:09:54.000 the BAA applications are open, 02:09:54.000 --> 02:09:58.000 submissions. But the only 02:09:58.000 --> 02:10:04.000 difference between the 24 and... 02:10:04.000 --> 02:10:06.000 [AUDIO DISTORTION] is that if 02:10:06.000 --> 02:10:08.000 the [INAUDIBLE] application on 02:10:08.000 --> 02:10:13.000 or by February 24th, it would be 02:10:13.000 --> 02:10:14.000 considered 02:10:14.000 --> 02:10:18.000 for FY25 and if it is received 02:10:18.000 --> 02:10:19.000 any time between February 25th 02:10:19.000 --> 02:10:24.000 to September 20th it would be 02:10:24.000 --> 02:10:27.000 considered for FY26. Any of the 02:10:27.000 --> 02:10:28.000 late or pending applications 02:10:28.000 --> 02:10:30.000 would be receiving notification 02:10:30.000 --> 02:10:35.000 regarding an outcome no later 02:10:35.000 --> 02:10:36.000 than December 1st 2025 02:10:36.000 --> 02:10:37.000 December 1st, 2025, and that 02:10:37.000 --> 02:10:38.000 December 1st, 2025, and that 02:10:38.000 --> 02:10:40.000 would be closing the 02:10:40.000 --> 02:10:44.000 notifications or the outcomes. 02:10:44.000 --> 02:10:47.000 Next slide, please. 02:10:47.000 --> 02:10:48.000 So these are some of the broad 02:10:48.000 --> 02:10:51.000 agency announcement frequently 02:10:51.000 --> 02:10:56.000 asked questions. Optional 02:10:56.000 --> 02:10:57.000 concept paper... consideration. 02:10:57.000 --> 02:10:59.000 [READING ON-SCREEN TEXT] if you 02:10:59.000 --> 02:11:01.000 have not submitted an early 02:11:01.000 --> 02:11:02.000 concept paper you're still free 02:11:02.000 --> 02:11:07.000 to submit a stage 1 package 02:11:07.000 --> 02:11:11.000 instead. Next, please 02:11:11.000 --> 02:11:12.000 . [READING ON-SCREEN TEXT] FF 02:11:12.000 --> 02:11:13.000 Read. 02:11:13.000 --> 02:11:15.000 It is a required document for 02:11:15.000 --> 02:11:18.000 stage 1 application it does not 02:11:18.000 --> 02:11:21.000 matter if you have submitted an 02:11:21.000 --> 02:11:22.000 early concept paper and 02:11:22.000 --> 02:11:24.000 recommend or do not recommend or 02:11:24.000 --> 02:11:28.000 if you're submitting a stage 1 02:11:28.000 --> 02:11:29.000 application for FY25 or FY26 02:11:29.000 --> 02:11:34.000 funding consideration. 02:11:34.000 --> 02:11:37.000 Next question, please. Does the 02:11:37.000 --> 02:11:40.000 3-page limit for concept paper 02:11:40.000 --> 02:11:43.000 include the cover table and YOEF 02:11:43.000 --> 02:11:45.000 table and overview? Yes. 02:11:45.000 --> 02:11:47.000 [AUDIO DISTORTION] for concept 02:11:47.000 --> 02:11:49.000 paper submissions. It does not 02:11:49.000 --> 02:11:51.000 matter if it is optional or 02:11:51.000 --> 02:11:55.000 required as part of stage 1 02:11:55.000 --> 02:11:58.000 application. The page limit 02:11:58.000 --> 02:11:59.000 which includes cover table and 02:11:59.000 --> 02:12:02.000 overview. 02:12:02.000 --> 02:12:03.000 Can a previously submitted 02:12:03.000 --> 02:12:08.000 concept paper be revised? 02:12:08.000 --> 02:12:10.000 Title, charge area and the 02:12:10.000 --> 02:12:11.000 regulatory science area fields 02:12:11.000 --> 02:12:14.000 cannot be revised or cannot be 02:12:14.000 --> 02:12:15.000 changed. That is due to 02:12:15.000 --> 02:12:17.000 administrative purposes. The 02:12:17.000 --> 02:12:19.000 moment we change that, it would 02:12:19.000 --> 02:12:23.000 create many difficulties and 02:12:23.000 --> 02:12:24.000 issues with the logistics of 02:12:24.000 --> 02:12:26.000 managing the review and the 02:12:26.000 --> 02:12:27.000 the proposals that was 02:12:27.000 --> 02:12:30.000 submitted. So please do not 02:12:30.000 --> 02:12:34.000 change the title, charge area, 02:12:34.000 --> 02:12:38.000 or regulatory fields. All other 02:12:38.000 --> 02:12:40.000 areas can be changed but we do 02:12:40.000 --> 02:12:42.000 recommend highly that you if you 02:12:42.000 --> 02:12:44.000 have made any changes please 02:12:44.000 --> 02:12:46.000 submit a version that includes 02:12:46.000 --> 02:12:48.000 highlights of the changes that 02:12:48.000 --> 02:12:52.000 have been made. Next slide, 02:12:52.000 --> 02:12:53.000 please. 02:12:53.000 --> 02:12:56.000 Is a full proposal required for 02:12:56.000 --> 02:12:58.000 for stage 1 application? Yes, 02:12:58.000 --> 02:13:02.000 a full proposal is required. 02:13:02.000 --> 02:13:04.000 Document for stage 1 application 02:13:04.000 --> 02:13:06.000 irrespective if an application 02:13:06.000 --> 02:13:10.000 has been made or if you are 02:13:10.000 --> 02:13:13.000 submitting an application for 02:13:13.000 --> 02:13:16.000 FI25 or FY26 consideration this 02:13:16.000 --> 02:13:17.000 it is a required document. 02:13:17.000 --> 02:13:22.000 document. Next question. 02:13:22.000 --> 02:13:23.000 Y25 or FY26 consideration it is 02:13:23.000 --> 02:13:24.000 a required document. Next 02:13:24.000 --> 02:13:25.000 question. [READING ON-SCREEN 02:13:25.000 --> 02:13:26.000 TEXT]. 02:13:26.000 --> 02:13:27.000 Yes, it is a requirement. Next 02:13:27.000 --> 02:13:28.000 question, please. [READING 02:13:28.000 --> 02:13:30.000 ON-SCREEN TEXT] can government 02:13:30.000 --> 02:13:33.000 employees collaborate on 02:13:33.000 --> 02:13:36.000 proposal development no. Thank 02:13:36.000 --> 02:13:38.000 you. Next question. What is 02:13:38.000 --> 02:13:40.000 the average timeline to receive 02:13:40.000 --> 02:13:42.000 an application acknowledgment? 02:13:42.000 --> 02:13:44.000 We... give us five business days 02:13:44.000 --> 02:13:48.000 from the date of submission 02:13:48.000 --> 02:13:51.000 prior to sending an email to FDA 02:13:51.000 --> 02:13:54.000 BAA inbox regarding the 02:13:54.000 --> 02:13:56.000 acknowledgment or receipt of 02:13:56.000 --> 02:13:58.000 your application. Next 02:13:58.000 --> 02:13:59.000 question, please. If the review 02:13:59.000 --> 02:14:01.000 process for applications 02:14:01.000 --> 02:14:05.000 received after February 24th D 02:14:05.000 --> 02:14:07.000 February 24th different? No 02:14:07.000 --> 02:14:09.000 the application is received on 02:14:09.000 --> 02:14:11.000 on or before February 24th. 02:14:11.000 --> 02:14:14.000 Only difference is with the 02:14:14.000 --> 02:14:16.000 timeline of... initiative these 02:14:16.000 --> 02:14:18.000 applications would be entered 02:14:18.000 --> 02:14:20.000 or reviewed only after the 02:14:20.000 --> 02:14:23.000 review of the applications 02:14:23.000 --> 02:14:28.000 received by February 24th has 02:14:28.000 --> 02:14:39.000 been initiated 02:14:39.000 --> 02:14:40.000 . 02:14:40.000 --> 02:14:44.000 [READING ON-SCREEN TEXT] is 02:14:44.000 --> 02:14:53.000 being posted on January 16th, 02:14:53.000 --> 02:14:57.000 on January 16th, 2025. I and 02:14:57.000 --> 02:15:00.000 my team would be able to take 02:15:00.000 --> 02:15:04.000 any questions. [READING 02:15:04.000 --> 02:15:07.000 ON-SCREEN TEXT]. 02:15:07.000 --> 02:15:10.000 Next slide, please. Thank you, 02:15:10.000 --> 02:15:13.000 once again. And I would be 02:15:13.000 --> 02:15:17.000 taking questions during the Q & 02:15:17.000 --> 02:15:20.000 A panel session. With that I 02:15:20.000 --> 02:15:22.000 would like to invite Ian to 02:15:22.000 --> 02:15:26.000 begin his presentation. Thank 02:15:26.000 --> 02:15:27.000 you. 02:15:27.000 --> 02:15:28.000 02:15:28.000 --> 02:15:30.000 >>IAN WEISS: Good afternoon, 02:15:30.000 --> 02:15:32.000 everyone I am the branch chief 02:15:32.000 --> 02:15:35.000 for the scientific support 02:15:35.000 --> 02:15:37.000 branch here at the office of 02:15:37.000 --> 02:15:39.000 acquisition and grants services 02:15:39.000 --> 02:15:41.000 for the FDA. 02:15:41.000 --> 02:15:43.000 And let's see. Just weight on 02:15:43.000 --> 02:15:47.000 Just waiting on the slides. 02:15:47.000 --> 02:15:52.000 There we go. Thank you. All 02:15:52.000 --> 02:15:54.000 right. Next slide, please. 02:15:54.000 --> 02:15:57.000 Okay just a little bit of 02:15:57.000 --> 02:15:58.000 background. We've heard quite a 02:15:58.000 --> 02:16:01.000 bit of this answer the day has 02:16:01.000 --> 02:16:05.000 worn on but we'll go ahead and 02:16:05.000 --> 02:16:10.000 rehash a little bit of this. 02:16:10.000 --> 02:16:13.000 The BAA program is used to spur 02:16:13.000 --> 02:16:14.000 regulatory science innovation 02:16:14.000 --> 02:16:15.000 in the scientific community and 02:16:15.000 --> 02:16:18.000 leverage its knowledge and IB 02:16:18.000 --> 02:16:21.000 FRA structure for regulatory 02:16:21.000 --> 02:16:23.000 science. It helps modernize 02:16:23.000 --> 02:16:24.000 infrastructure for regulatory 02:16:24.000 --> 02:16:25.000 science. It helps modernize 02:16:25.000 --> 02:16:26.000 development and evaluation of 02:16:26.000 --> 02:16:27.000 FDA-regulated products strengths 02:16:27.000 --> 02:16:30.000 postmarket surveillance and 02:16:30.000 --> 02:16:32.000 labelling of FDA regulated 02:16:32.000 --> 02:16:36.000 products and invigorate public 02:16:36.000 --> 02:16:40.000 health preprePARDedness 02:16:40.000 --> 02:16:45.000 remember encouraging any firms. 02:16:45.000 --> 02:16:48.000 . If just so you know, 02:16:48.000 --> 02:16:53.000 the BAA's issued under the 02:16:53.000 --> 02:17:00.000 federal acquisitions 02:17:00.000 --> 02:17:04.000 FAR part 35.016 Charlie. The 02:17:04.000 --> 02:17:06.000 opportunity to present and gives 02:17:06.000 --> 02:17:10.000 a -- an opportunity to present 02:17:10.000 --> 02:17:13.000 ideas and proposaling 02:17:13.000 --> 02:17:14.000 to the thought leaders for the 02:17:14.000 --> 02:17:19.000 consideration. 02:17:19.000 --> 02:17:24.000 We posted this year's FY25 on 02:17:24.000 --> 02:17:28.000 Sam.gov. It's 02:17:28.000 --> 02:17:30.000 It's open to all responsible 02:17:30.000 --> 02:17:32.000 sources and small businesses are 02:17:32.000 --> 02:17:33.000 strongly encouraged to respond. 02:17:33.000 --> 02:17:35.000 Okay. Contracts will be the 02:17:35.000 --> 02:17:38.000 instrument used to make awards, 02:17:38.000 --> 02:17:39.000 not grants we get a lot of 02:17:39.000 --> 02:17:40.000 confusion about that every year. 02:17:40.000 --> 02:17:42.000 So we'll talk about that a 02:17:42.000 --> 02:17:44.000 little bit more and it's always 02:17:44.000 --> 02:17:47.000 based on the funding available. 02:17:47.000 --> 02:17:50.000 So FY24 there were 24 awards. I 02:17:50.000 --> 02:17:52.000 know we've -- we've posted a -- 02:17:52.000 --> 02:17:54.000 the one year total was something 02:17:54.000 --> 02:17:56.000 like 24 million. The overall 02:17:56.000 --> 02:17:58.000 value over the course of some 02:17:58.000 --> 02:18:00.000 some of the contracts have 02:18:00.000 --> 02:18:02.000 multiple years and option 02:18:02.000 --> 02:18:04.000 periods and things of that 02:18:04.000 --> 02:18:07.000 nature. The overall value of 02:18:07.000 --> 02:18:10.000 all of the contracts was 30 -- 02:18:10.000 --> 02:18:11.000 right around $39 million. And 02:18:11.000 --> 02:18:15.000 we anticipated a similar number 02:18:15.000 --> 02:18:18.000 of awards and value this year. 02:18:18.000 --> 02:18:22.000 And next slide, please. All 02:18:22.000 --> 02:18:26.000 right. So again, you know we 02:18:26.000 --> 02:18:31.000 we sew LIS at this timed 02:18:31.000 --> 02:18:34.000 we sew LIS at this timed under 02:18:34.000 --> 02:18:37.000 the BA program will #24R to 02:18:37.000 --> 02:18:38.000 listeded under the BA program 02:18:38.000 --> 02:18:40.000 will to protect and moment the 02:18:40.000 --> 02:18:42.000 health of our nation the result 02:18:42.000 --> 02:18:44.000 of this process is various 02:18:44.000 --> 02:18:47.000 proposals will be selected to 02:18:47.000 --> 02:18:49.000 awarded contracts. Next 02:18:49.000 --> 02:18:50.000 Next slide, please. What is 02:18:50.000 --> 02:18:51.000 the difference between a 02:18:51.000 --> 02:18:56.000 a contract and a grant. And 02:18:56.000 --> 02:19:00.000 again, the BAA process gets us 02:19:00.000 --> 02:19:03.000 to -- final result of awarding 02:19:03.000 --> 02:19:04.000 contracts. So federal grants 02:19:04.000 --> 02:19:11.000 and federal accounts have 02:19:11.000 --> 02:19:15.000 contracts have differences. 02:19:15.000 --> 02:19:19.000 [READING ON-SCREEN TEXT] whereas 02:19:19.000 --> 02:19:22.000 it uses 02:19:22.000 --> 02:19:26.000 use grants are much more 02:19:26.000 --> 02:19:28.000 flexible. Typically federal 02:19:28.000 --> 02:19:33.000 contracts changes cannot easily 02:19:33.000 --> 02:19:35.000 be made. One of significance is 02:19:35.000 --> 02:19:37.000 failure to deliver under a 02:19:37.000 --> 02:19:41.000 contract can have consequences 02:19:41.000 --> 02:19:44.000 whereas in case of 02:19:44.000 --> 02:19:46.000 a grant a report that's a very 02:19:46.000 --> 02:19:49.000 long winded way to say for a 02:19:49.000 --> 02:19:50.000 for a contract we need to have 02:19:50.000 --> 02:19:54.000 a final outcome. All of your 02:19:54.000 --> 02:19:58.000 your proposal 02:19:58.000 --> 02:19:59.000 s should have a final outcome 02:19:59.000 --> 02:20:02.000 whether it's a manuscript, or a 02:20:02.000 --> 02:20:03.000 a development of PIENS of 02:20:03.000 --> 02:20:05.000 scientific equipment whatever 02:20:05.000 --> 02:20:10.000 that is, there should be a final 02:20:10.000 --> 02:20:14.000 output for these POP 02:20:14.000 --> 02:20:16.000 proposals. We talk about 02:20:16.000 --> 02:20:17.000 science of scientific equipment 02:20:17.000 --> 02:20:18.000 whatever that is, there should 02:20:18.000 --> 02:20:19.000 be a final output for these proposals. We talk about 02:20:19.000 --> 02:20:20.000 severability. We could have a 1 02:20:20.000 --> 02:20:23.000 a 1 whole presentation 02:20:23.000 --> 02:20:24.000 on that. You want to 02:20:24.000 --> 02:20:27.000 definitely describe whether or 02:20:27.000 --> 02:20:31.000 not you have a severable or 02:20:31.000 --> 02:20:41.000 nonseverable proposal 02:20:41.000 --> 02:20:45.000 . [READING ON-SCREEN TEXT]. 02:20:45.000 --> 02:20:49.000 So we definitely have a 02:20:49.000 --> 02:20:52.000 preference 02:20:52.000 --> 02:20:56.000 severable services. Whether a 02:20:56.000 --> 02:20:59.000 a contract, services affects 02:20:59.000 --> 02:21:01.000 how the agencies may fund the 02:21:01.000 --> 02:21:04.000 contract, they may be 02:21:04.000 --> 02:21:06.000 incrementally funded while 02:21:06.000 --> 02:21:07.000 nonseverable services contracts 02:21:07.000 --> 02:21:09.000 must be fully funded at the 02:21:09.000 --> 02:21:10.000 time of the award of the 02:21:10.000 --> 02:21:12.000 contract. Basically what we're 02:21:12.000 --> 02:21:15.000 saying here is that if you have 02:21:15.000 --> 02:21:17.000 a severable contract and we can 02:21:17.000 --> 02:21:20.000 break it up into pieces it makes 02:21:20.000 --> 02:21:22.000 it more likely that you would 02:21:22.000 --> 02:21:25.000 get consideration for funding. 02:21:25.000 --> 02:21:27.000 It is, you know, when we have -- 02:21:27.000 --> 02:21:28.000 when we can break the funding up 02:21:28.000 --> 02:21:30.000 into different pieces over 02:21:30.000 --> 02:21:32.000 different fiscal years, it 02:21:32.000 --> 02:21:35.000 definitely makes it easier for 02:21:35.000 --> 02:21:40.000 us to consider your -- consider 02:21:40.000 --> 02:21:45.000 your proposal 02:21:45.000 --> 02:21:47.000 for a contract award just from 02:21:47.000 --> 02:21:52.000 a funding standpoint. Can we 02:21:52.000 --> 02:21:54.000 expectation negotiations 02:21:54.000 --> 02:21:56.000 ? It depends on a lot of 02:21:56.000 --> 02:21:57.000 variables but they are always 02:21:57.000 --> 02:22:01.000 possible. About 50 percent of 02:22:01.000 --> 02:22:04.000 of the contracts required some 02:22:04.000 --> 02:22:06.000 level of he gaucheuationings 02:22:06.000 --> 02:22:16.000 this past year. [READING 02:22:16.000 --> 02:22:20.000 negotiations this past year. 02:22:20.000 --> 02:22:21.000 [READING ON-SCREEN TEXT]. 02:22:21.000 --> 02:22:24.000 That's me. For specific 02:22:24.000 --> 02:22:26.000 feedback and we'll do what we 02:22:26.000 --> 02:22:28.000 can to get you some additional 02:22:28.000 --> 02:22:31.000 feedback. 02:22:31.000 --> 02:22:33.000 What about SAM registration? 02:22:33.000 --> 02:22:35.000 And this is a big one for some 02:22:35.000 --> 02:22:37.000 reason, every year we get a few 02:22:37.000 --> 02:22:39.000 folks that submit and either 02:22:39.000 --> 02:22:42.000 they're SAM registration SPT 02:22:42.000 --> 02:22:45.000 ready or it lapsed or something 02:22:45.000 --> 02:22:46.000 of that nature. You want to 02:22:46.000 --> 02:22:49.000 make sure that you have your 02:22:49.000 --> 02:22:53.000 your SAM registration up to 02:22:53.000 --> 02:22:54.000 date and ready for all awards 02:22:54.000 --> 02:22:55.000 isn't ready or it lapsed or 02:22:55.000 --> 02:22:56.000 something of that nature. You want to make sure that you have 02:22:56.000 --> 02:22:57.000 your SAM registration up to date 02:22:57.000 --> 02:22:58.000 and ready for all awards. The 02:22:58.000 --> 02:22:59.000 recommendation is that you have 02:22:59.000 --> 02:23:00.000 that by proposal submission but 02:23:00.000 --> 02:23:02.000 absolutely by the time we go to 02:23:02.000 --> 02:23:03.000 award you must have your SAM 02:23:03.000 --> 02:23:04.000 registration up to date and 02:23:04.000 --> 02:23:07.000 ready for all awards. 02:23:07.000 --> 02:23:09.000 To answer a question that we get 02:23:09.000 --> 02:23:11.000 quite often, what if you're a 02:23:11.000 --> 02:23:14.000 foreign vendor? If you're a 02:23:14.000 --> 02:23:15.000 you're a foreign vendor, 02:23:15.000 --> 02:23:16.000 foreign educational 02:23:16.000 --> 02:23:21.000 institution, you still need to 02:23:21.000 --> 02:23:22.000 to be registered 02:23:22.000 --> 02:23:24.000 in SAM there's an additional 02:23:24.000 --> 02:23:28.000 process and that takes even more 02:23:28.000 --> 02:23:29.000 time. So what I would say is if 02:23:29.000 --> 02:23:31.000 you're not currently registered 02:23:31.000 --> 02:23:33.000 and if you are thinking about 02:23:33.000 --> 02:23:35.000 putting in a proposal I would 02:23:35.000 --> 02:23:36.000 start working on this SAM 02:23:36.000 --> 02:23:41.000 registration now. 02:23:41.000 --> 02:23:47.000 Next slide. So and again, what 02:23:47.000 --> 02:23:49.000 if you're new to the process, 02:23:49.000 --> 02:23:53.000 or a small business? Welcome. 02:23:53.000 --> 02:23:56.000 FDA's always happy to have you 02:23:56.000 --> 02:23:59.000 here. Always talk to your 02:23:59.000 --> 02:24:00.000 contracting officer that's me. 02:24:00.000 --> 02:24:04.000 We can point you to resources 02:24:04.000 --> 02:24:05.000 answer general questions, 02:24:05.000 --> 02:24:10.000 clarify points of federal 02:24:10.000 --> 02:24:12.000 complex and complexity. I 02:24:12.000 --> 02:24:14.000 I can't review your proposal, 02:24:14.000 --> 02:24:19.000 answering what should I research 02:24:19.000 --> 02:24:20.000 or what are my chances and not 02:24:20.000 --> 02:24:23.000 what people are submitting. We 02:24:23.000 --> 02:24:25.000 We also can't directly answer 02:24:25.000 --> 02:24:27.000 what the budget is this year. 02:24:27.000 --> 02:24:30.000 Everybody always wants to know 02:24:30.000 --> 02:24:32.000 to know and that's just not a 02:24:32.000 --> 02:24:35.000 question we can answer. When it 02:24:35.000 --> 02:24:38.000 comes to contracting, a lot of 02:24:38.000 --> 02:24:41.000 times the answers depend but we 02:24:41.000 --> 02:24:43.000 will try our best to get your 02:24:43.000 --> 02:24:45.000 questions answered. All right. 02:24:45.000 --> 02:24:48.000 Next slide, please. 02:24:48.000 --> 02:24:52.000 And I guess we can go jump into 02:24:52.000 --> 02:25:02.000 Q & A. 02:25:02.000 --> 02:25:04.000 We've got Kinnera and 02:25:04.000 --> 02:25:08.000 her team for process questions. 02:25:08.000 --> 02:25:10.000 Let's see here. 02:25:10.000 --> 02:25:12.000 >>DR. KINNERA CHADA: So I just 02:25:12.000 --> 02:25:14.000 wanted to say that I apologize 02:25:14.000 --> 02:25:16.000 for the audio interruption. I 02:25:16.000 --> 02:25:18.000 I will be recording my 02:25:18.000 --> 02:25:23.000 presentation and posting as a 02:25:23.000 --> 02:25:29.000 video on the meeting material 02:25:29.000 --> 02:25:32.000 page. 02:25:32.000 --> 02:25:34.000 >>IAN WEISS: Great. Let's see 02:25:34.000 --> 02:25:36.000 here. 02:25:36.000 --> 02:25:40.000 >> Thank you, Ian. I have a 02:25:40.000 --> 02:25:41.000 couple questions that came prior 02:25:41.000 --> 02:25:42.000 for K 02:25:42.000 --> 02:25:44.000 for K 02:25:44.000 --> 02:25:46.000 for Kinnera 02:25:46.000 --> 02:25:48.000 >> All right. 02:25:48.000 --> 02:25:50.000 >> Let's see will funding be the 02:25:50.000 --> 02:25:54.000 same as last year or higher oar 02:25:54.000 --> 02:25:55.000 high or lower 02:25:55.000 --> 02:25:57.000 ? 02:25:57.000 --> 02:25:59.000 >>IAN WEISS: Well we anticipate 02:25:59.000 --> 02:26:02.000 it'll be about the same. I 02:26:02.000 --> 02:26:05.000 certainly KBT give a number but 02:26:05.000 --> 02:26:07.000 can't give a number but probably 02:26:07.000 --> 02:26:08.000 about the same. Thank you. 02:26:08.000 --> 02:26:09.000 Next question is: What is 02:26:09.000 --> 02:26:11.000 happening with the full 02:26:11.000 --> 02:26:13.000 proposals that were submitted 02:26:13.000 --> 02:26:18.000 last year but not awarded 02:26:18.000 --> 02:26:19.000 because the FY24 funds ran out? 02:26:19.000 --> 02:26:21.000 >>IAN WEISS: There should've 02:26:21.000 --> 02:26:25.000 been a notices to all of those 02:26:25.000 --> 02:26:26.000 vendors that 02:26:26.000 --> 02:26:28.000 they weren't selected due to 02:26:28.000 --> 02:26:31.000 lack of funding if they got 02:26:31.000 --> 02:26:32.000 those notices then they are 02:26:32.000 --> 02:26:34.000 welcome to resubmit this year. 02:26:34.000 --> 02:26:38.000 If they were -- they should've 02:26:38.000 --> 02:26:42.000 also been notified 02:26:42.000 --> 02:26:44.000 if they were hold overs as 02:26:44.000 --> 02:26:47.000 Kinnera stated we have a process 02:26:47.000 --> 02:26:51.000 by can which we can award a 02:26:51.000 --> 02:26:52.000 a limited number of contracts 02:26:52.000 --> 02:26:55.000 in the first quarter and those 02:26:55.000 --> 02:26:56.000 folks should've been notified as 02:26:56.000 --> 02:26:59.000 well. 02:26:59.000 --> 02:27:02.000 >> Thank you, Ian. What are the 02:27:02.000 --> 02:27:06.000 timelines for the BAA? I think 02:27:06.000 --> 02:27:08.000 that was covered in Dr. 02:27:08.000 --> 02:27:10.000 in the presentation. Next 02:27:10.000 --> 02:27:13.000 question would be: What are the 02:27:13.000 --> 02:27:15.000 key components of a strong 02:27:15.000 --> 02:27:19.000 concept paper? Are policy 02:27:19.000 --> 02:27:22.000 analysis questions of interest 02:27:22.000 --> 02:27:25.000 to the FDA? 02:27:25.000 --> 02:27:27.000 >>IAN WEISS: Let's see. Like I 02:27:27.000 --> 02:27:30.000 said, it's -- maybe a more of a 02:27:30.000 --> 02:27:32.000 question for some of our program 02:27:32.000 --> 02:27:35.000 folks that review those concept 02:27:35.000 --> 02:27:36.000 papers. 02:27:36.000 --> 02:27:39.000 >>DR. KINNERA CHADA: I would 02:27:39.000 --> 02:27:43.000 say that if this was part of 02:27:43.000 --> 02:27:45.000 this... announcement any... 02:27:45.000 --> 02:27:46.000 related then it would be of 02:27:46.000 --> 02:27:48.000 interest. If it was not [AUDIO 02:27:48.000 --> 02:27:50.000 DISTORTION] included in the 02:27:50.000 --> 02:27:52.000 scope, then that might be 02:27:52.000 --> 02:27:56.000 something that FDA is not 02:27:56.000 --> 02:27:59.000 interested in. 02:27:59.000 --> 02:28:00.000 >> Thank you, Kinnera next 02:28:00.000 --> 02:28:04.000 question is: What has changed 02:28:04.000 --> 02:28:08.000 from last year relative to the 02:28:08.000 --> 02:28:09.000 proposal submission process? 02:28:09.000 --> 02:28:11.000 >>DR. KINNERA CHADA: There has 02:28:11.000 --> 02:28:14.000 been no changes. The only 02:28:14.000 --> 02:28:18.000 change would be that if a stage 02:28:18.000 --> 02:28:21.000 2 is invited, then the response 02:28:21.000 --> 02:28:23.000 timeline for the revised 02:28:23.000 --> 02:28:25.000 proposal would be 14 days 02:28:25.000 --> 02:28:26.000 instead of 30 days. That has 02:28:26.000 --> 02:28:29.000 been the only change. Other 02:28:29.000 --> 02:28:31.000 than that, we have not made any 02:28:31.000 --> 02:28:33.000 changes to the application or 02:28:33.000 --> 02:28:37.000 review process. 02:28:37.000 --> 02:28:40.000 >> Thank you, Kinnera there's a 02:28:40.000 --> 02:28:42.000 question for women's health so 02:28:42.000 --> 02:28:43.000 we'll reach out to the office 02:28:43.000 --> 02:28:46.000 and provide an answer if that 02:28:46.000 --> 02:28:48.000 for that. The next question in 02:28:48.000 --> 02:28:50.000 the chat is: Is there a 02:28:50.000 --> 02:28:54.000 difference between the three 02:28:54.000 --> 02:28:55.000 lack of funding types? 02:28:55.000 --> 02:28:57.000 >>DR. KINNERA CHADA: I think 02:28:57.000 --> 02:28:59.000 this might be relevant to my 02:28:59.000 --> 02:29:02.000 presentation, Jessica. There 02:29:02.000 --> 02:29:03.000 were two categoryings for lack 02:29:03.000 --> 02:29:05.000 of funding one was associated 02:29:05.000 --> 02:29:07.000 with the concept paper review. 02:29:07.000 --> 02:29:08.000 If you look at the review 02:29:08.000 --> 02:29:12.000 process which was described 02:29:12.000 --> 02:29:13.000 as part of my presentation, 02:29:13.000 --> 02:29:14.000 there is high-level review of 02:29:14.000 --> 02:29:17.000 of the concept papers during 02:29:17.000 --> 02:29:19.000 that review, the program leaders 02:29:19.000 --> 02:29:21.000 and officers determine that 02:29:21.000 --> 02:29:23.000 there are no funds available and 02:29:23.000 --> 02:29:26.000 there would be no point in niche 02:29:26.000 --> 02:29:29.000 in initiating a review of the 02:29:29.000 --> 02:29:31.000 full proposal, then we would be 02:29:31.000 --> 02:29:33.000 notifying it as lack of funds 02:29:33.000 --> 02:29:35.000 based on the review of the 02:29:35.000 --> 02:29:36.000 concept paper only. The other 02:29:36.000 --> 02:29:39.000 category would be when the 02:29:39.000 --> 02:29:43.000 review has been initiated the 02:29:43.000 --> 02:29:45.000 technical evaluation panel has 02:29:45.000 --> 02:29:48.000 reviewed the proposal. But at 02:29:48.000 --> 02:29:51.000 at the end, after a recommend 02:29:51.000 --> 02:29:53.000 for award from the panel, there 02:29:53.000 --> 02:29:55.000 has been no funds for the 02:29:55.000 --> 02:29:58.000 program of this. In those SNAR 02:29:58.000 --> 02:30:03.000 scenarios that is when a regret 02:30:03.000 --> 02:30:06.000 notification with lack of funds 02:30:06.000 --> 02:30:11.000 would be informed. 02:30:11.000 --> 02:30:12.000 >> Thank you, 02:30:12.000 --> 02:30:15.000 Kinnera. Next question is: 02:30:15.000 --> 02:30:17.000 There have been limited funding 02:30:17.000 --> 02:30:19.000 of project with social science 02:30:19.000 --> 02:30:21.000 behavioral focus this past year. 02:30:21.000 --> 02:30:24.000 Do you anticipate similar trend 02:30:24.000 --> 02:30:25.000 this year? 02:30:25.000 --> 02:30:27.000 >>IAN WEISS: I can't speak to 02:30:27.000 --> 02:30:29.000 to that directly but again I 02:30:29.000 --> 02:30:31.000 think the overall funding of 02:30:31.000 --> 02:30:33.000 projects is going to look very 02:30:33.000 --> 02:30:37.000 similar this year than it did to 02:30:37.000 --> 02:30:39.000 last year, so. Yeah. I -- I 02:30:39.000 --> 02:30:41.000 would say the answer is yes, 02:30:41.000 --> 02:30:46.000 most likely. 02:30:46.000 --> 02:30:48.000 >> Thank you, 02:30:48.000 --> 02:30:52.000 Ian. Next question: Is there 02:30:52.000 --> 02:30:54.000 a timeframe for hearing about 02:30:54.000 --> 02:30:55.000 applications that are pending? 02:30:55.000 --> 02:30:56.000 I believe I already answered 02:30:56.000 --> 02:30:57.000 that. 02:30:57.000 --> 02:30:59.000 >>DR. KINNERA CHADA: Yes that 02:30:59.000 --> 02:31:00.000 was answered in my presentation, 02:31:00.000 --> 02:31:02.000 Jessica, which would be December 02:31:02.000 --> 02:31:06.000 would be December 6th. 02:31:06.000 --> 02:31:09.000 >> Thank you, Kinnera. Who 02:31:09.000 --> 02:31:11.000 reviews the concept proposals? 02:31:11.000 --> 02:31:12.000 Are the needs of the centers, 02:31:12.000 --> 02:31:17.000 offices that are presented today 02:31:17.000 --> 02:31:18.000 given priority? 02:31:18.000 --> 02:31:19.000 02:31:19.000 --> 02:31:20.000 >>DR. KINNERA CHADA: They are 02:31:20.000 --> 02:31:22.000 part of the review team for the 02:31:22.000 --> 02:31:23.000 concept papers. They have also 02:31:23.000 --> 02:31:26.000 other members who have not 02:31:26.000 --> 02:31:28.000 presented today but have 02:31:28.000 --> 02:31:30.000 contributed to the scope of BAA 02:31:30.000 --> 02:31:35.000 announcement that has been 02:31:35.000 --> 02:31:36.000 posted on Sam.gov. 02:31:36.000 --> 02:31:38.000 02:31:38.000 --> 02:31:39.000 >> If we weren't able to submit 02:31:39.000 --> 02:31:43.000 is there another way to get 02:31:43.000 --> 02:31:44.000 high-level feedback on an idea 02:31:44.000 --> 02:31:45.000 ? 02:31:45.000 --> 02:31:47.000 >>DR. KINNERA CHADA: Not that I 02:31:47.000 --> 02:31:51.000 know of. I would like to defer 02:31:51.000 --> 02:31:53.000 this question 02:31:53.000 --> 02:31:55.000 to Ian. 02:31:55.000 --> 02:31:57.000 >> They could aalways forward 02:31:57.000 --> 02:32:00.000 the question to me but there's 02:32:00.000 --> 02:32:03.000 not a formal process there to 02:32:03.000 --> 02:32:06.000 get additional feedback. 02:32:06.000 --> 02:32:08.000 >> Thank you. Next question: 02:32:08.000 --> 02:32:10.000 If an early concept paper was 02:32:10.000 --> 02:32:14.000 submitted with title page and 02:32:14.000 --> 02:32:15.000 and table of contents will that 02:32:15.000 --> 02:32:18.000 count as part of the three page 02:32:18.000 --> 02:32:20.000 limit and therefore only one 02:32:20.000 --> 02:32:23.000 page of the concept paper 02:32:23.000 --> 02:32:24.000 content will be considered? 02:32:24.000 --> 02:32:25.000 02:32:25.000 --> 02:32:26.000 >>DR. KINNERA CHADA: I would 02:32:26.000 --> 02:32:28.000 suggest that you follow the 02:32:28.000 --> 02:32:30.000 template which is provided as 02:32:30.000 --> 02:32:34.000 attachment 4 of the BA 02:32:34.000 --> 02:32:37.000 aannouncement if you follow the 02:32:37.000 --> 02:32:40.000 the template there will not be 02:32:40.000 --> 02:32:43.000 any issues. Concept paper would 02:32:43.000 --> 02:32:44.000 include cover table and also the 02:32:44.000 --> 02:32:46.000 concept paper overview. These 02:32:46.000 --> 02:32:48.000 are the two sections which are 02:32:48.000 --> 02:32:56.000 included as part of the three 02:32:56.000 --> 02:32:57.000 nnouncement if you follow the 02:32:57.000 --> 02:32:58.000 template there will not be any issues. Concept paper would 02:32:58.000 --> 02:32:59.000 include cover table and also the 02:32:59.000 --> 02:33:00.000 concept paper overview. These are the two sections which are 02:33:00.000 --> 02:33:01.000 included as part of the three 02:33:01.000 --> 02:33:02.000 page limit. 02:33:02.000 --> 02:33:03.000 >> Thank you. Next question: 02:33:03.000 --> 02:33:04.000 Is it potential for 24 PROLs 02:33:04.000 --> 02:33:05.000 for 24 proposals that are 02:33:05.000 --> 02:33:08.000 severable to be awarded with 02:33:08.000 --> 02:33:11.000 with part given the 39 million 02:33:11.000 --> 02:33:12.000 awarded? It is unclear if that 02:33:12.000 --> 02:33:14.000 includes potential pending 02:33:14.000 --> 02:33:17.000 proposals or could increase with 02:33:17.000 --> 02:33:19.000 pending proposals. 02:33:19.000 --> 02:33:20.000 >>IAN WEISS: So if I understand 02:33:20.000 --> 02:33:22.000 the question correctly they're 02:33:22.000 --> 02:33:24.000 asking you know if they're 02:33:24.000 --> 02:33:26.000 pending I guess the first part 02:33:26.000 --> 02:33:27.000 of that question, if they're 02:33:27.000 --> 02:33:28.000 pending is it -- is there 02:33:28.000 --> 02:33:33.000 potentially still a possibility 02:33:33.000 --> 02:33:35.000 for award, yes. 02:33:35.000 --> 02:33:37.000 Kinnera definitely covered that 02:33:37.000 --> 02:33:41.000 in her presentation. 02:33:41.000 --> 02:33:44.000 With as far as the total amount 02:33:44.000 --> 02:33:48.000 being submitted, or already been 02:33:48.000 --> 02:33:52.000 posted for 39 million, anything 02:33:52.000 --> 02:33:56.000 that's awarded 02:33:56.000 --> 02:34:00.000 in FY25 would be listed 02:34:00.000 --> 02:34:01.000 in the FY25 awards. I think I 02:34:01.000 --> 02:34:02.000 answered what was being asked 02:34:02.000 --> 02:34:04.000 there. 02:34:04.000 --> 02:34:06.000 >> Thank you, Ian. I think this 02:34:06.000 --> 02:34:09.000 is more of an office question. 02:34:09.000 --> 02:34:13.000 What is the maximum funding for 02:34:13.000 --> 02:34:15.000 for the PFAs in dairy cattle 02:34:15.000 --> 02:34:18.000 call? 02:34:18.000 --> 02:34:21.000 >> We can check with the center 02:34:21.000 --> 02:34:22.000 of veterinary pled and get back 02:34:22.000 --> 02:34:23.000 to them on this. 02:34:23.000 --> 02:34:26.000 02:34:26.000 --> 02:34:28.000 >> Thank you. The submission is 02:34:28.000 --> 02:34:30.000 via email right? Can you 02:34:30.000 --> 02:34:31.000 explain how that is related to 02:34:31.000 --> 02:34:32.000 SAM registration? 02:34:32.000 --> 02:34:33.000 >> That's an excellent question. 02:34:33.000 --> 02:34:37.000 So yeah the submission is via e 02:34:37.000 --> 02:34:42.000 email. 02:34:42.000 --> 02:34:45.000 It's FDAB A. It goes to the 02:34:45.000 --> 02:34:47.000 to the inbox that is completely 02:34:47.000 --> 02:34:49.000 separate from your SA 02:34:49.000 --> 02:34:51.000 registration. You need to go to 02:34:51.000 --> 02:34:52.000 SAM.gov and become a registered 02:34:52.000 --> 02:34:54.000 entity on that website in order 02:34:54.000 --> 02:34:57.000 to -- not being registered 02:34:57.000 --> 02:34:59.000 doesn't prevent you from 02:34:59.000 --> 02:35:02.000 putting in a proposal, even 02:35:02.000 --> 02:35:05.000 though ZA said earlier, you want 02:35:05.000 --> 02:35:08.000 to -- my recommendation is you 02:35:08.000 --> 02:35:10.000 have that squared away. It can 02:35:10.000 --> 02:35:12.000 take weeks if not months to get 02:35:12.000 --> 02:35:13.000 on there. If you're not already 02:35:13.000 --> 02:35:15.000 on there. But yeah it's a 02:35:15.000 --> 02:35:17.000 completely separate process to 02:35:17.000 --> 02:35:20.000 submitting your proposal and 02:35:20.000 --> 02:35:22.000 getting registered on Sam.gov. 02:35:22.000 --> 02:35:26.000 It does not prevent you from 02:35:26.000 --> 02:35:28.000 putting in your proposal 02:35:28.000 --> 02:35:30.000 in your [coughing] pardon e 02:35:30.000 --> 02:35:32.000 many. If you're not registered 02:35:32.000 --> 02:35:34.000 and in good standing for all 02:35:34.000 --> 02:35:37.000 awards we would be prevented 02:35:37.000 --> 02:35:39.000 from issuing a contract should 02:35:39.000 --> 02:35:41.000 we get to the end, so. And 02:35:41.000 --> 02:35:45.000 And we have had that happen, 02:35:45.000 --> 02:35:50.000 so. Again, the -- working 02:35:50.000 --> 02:35:54.000 in pan DEM having 02:35:54.000 --> 02:35:57.000 any of the contract works, 02:35:57.000 --> 02:35:58.000 getting registered couldn't be 02:35:58.000 --> 02:36:02.000 more highly recommended 02:36:02.000 --> 02:36:05.000 >> Thank you Ian. Next question 02:36:05.000 --> 02:36:08.000 . Are there any rules regarding 02:36:08.000 --> 02:36:09.000 potential overlap with NIH 02:36:09.000 --> 02:36:10.000 funding? 02:36:10.000 --> 02:36:13.000 >>IAN WEISS: So I think the 02:36:13.000 --> 02:36:15.000 the question there is, kind of 02:36:15.000 --> 02:36:16.000 a grant-related question. So 02:36:16.000 --> 02:36:19.000 just want to remind everybody 02:36:19.000 --> 02:36:22.000 that these are contracts and you 02:36:22.000 --> 02:36:24.000 can't intermingle contract funds 02:36:24.000 --> 02:36:28.000 from one contract to another. 02:36:28.000 --> 02:36:29.000 So the answer for is, yes there 02:36:29.000 --> 02:36:31.000 would be an issue intermingling 02:36:31.000 --> 02:36:35.000 funds. If you have a contract 02:36:35.000 --> 02:36:37.000 with NIH, those funds can't 02:36:37.000 --> 02:36:40.000 intermingle with anything with 02:36:40.000 --> 02:36:41.000 our contract and vice versa. 02:36:41.000 --> 02:36:43.000 Just be careful. If they are 02:36:43.000 --> 02:36:46.000 grants it's a little bit 02:36:46.000 --> 02:36:48.000 different but if it's acontract 02:36:48.000 --> 02:36:49.000 to contract, you cannot 02:36:49.000 --> 02:36:52.000 intermingle those funds. 02:36:52.000 --> 02:36:56.000 >> Thank you, Ian. It is 02:36:56.000 --> 02:36:59.000 possible for two institutes 02:36:59.000 --> 02:37:01.000 to collaboratively submit an 02:37:01.000 --> 02:37:02.000 application? 02:37:02.000 --> 02:37:03.000 >>IAN WEISS: Absolutely. 02:37:03.000 --> 02:37:07.000 >> Thank you. For resubmission 02:37:07.000 --> 02:37:09.000 of last year FDABAA, what 02:37:09.000 --> 02:37:11.000 would be the project starting 02:37:11.000 --> 02:37:12.000 date? 02:37:12.000 --> 02:37:13.000 >>IAN WEISS: So it depends. 02:37:13.000 --> 02:37:17.000 Most of the contracts are 02:37:17.000 --> 02:37:20.000 awarded between July and 02:37:20.000 --> 02:37:21.000 September. The starting date 02:37:21.000 --> 02:37:24.000 would be you can specify a 02:37:24.000 --> 02:37:26.000 starting date if you didn't want 02:37:26.000 --> 02:37:30.000 to start until the end of the 02:37:30.000 --> 02:37:33.000 of the fiscal year. We've had 02:37:33.000 --> 02:37:35.000 two weeks from awarded contract. 02:37:35.000 --> 02:37:39.000 But as far as for planning 02:37:39.000 --> 02:37:44.000 purposes most of the con 02:37:44.000 --> 02:37:45.000 of the contracts 02:37:45.000 --> 02:37:49.000 are ward between July ask & 02:37:49.000 --> 02:37:51.000 July and September. 02:37:51.000 --> 02:37:56.000 >> Can federal employees would 02:37:56.000 --> 02:37:58.000 be... PIs if registered in SAMs 02:37:58.000 --> 02:38:03.000 ? I believe she covered that in 02:38:03.000 --> 02:38:04.000 her presentation. 02:38:04.000 --> 02:38:07.000 >>DR. KINNERA CHADA: Might be 02:38:07.000 --> 02:38:08.000 good to reiterate, Ian. 02:38:08.000 --> 02:38:09.000 >>IAN WEISS: Yeah, so -- 02:38:09.000 --> 02:38:10.000 >>DR. KINNERA CHADA: Provide an 02:38:10.000 --> 02:38:11.000 answer question. 02:38:11.000 --> 02:38:14.000 02:38:14.000 --> 02:38:15.000 >>IAN WEISS: So you could be a 02:38:15.000 --> 02:38:17.000 PI, you can't be -- you can't 02:38:17.000 --> 02:38:20.000 put in a proposal all on your 02:38:20.000 --> 02:38:21.000 own but technically you could be 02:38:21.000 --> 02:38:24.000 a PI but if you're a federal 02:38:24.000 --> 02:38:26.000 employee check with your it's 02:38:26.000 --> 02:38:32.000 IBs office to make sure there's 02:38:32.000 --> 02:38:33.000 no a conflict of interest there 02:38:33.000 --> 02:38:34.000 ethics office to make sure 02:38:34.000 --> 02:38:35.000 there's no a conflict of 02:38:35.000 --> 02:38:36.000 interest there. 02:38:36.000 --> 02:38:37.000 >> Thank you, Ian. 02:38:37.000 --> 02:38:39.000 >>IAN WEISS: Looks like it's 02:38:39.000 --> 02:38:43.000 it's the same question. 02:38:43.000 --> 02:38:46.000 >> Yeah. Does the institution 02:38:46.000 --> 02:38:49.000 need to be registered with SAM 02:38:49.000 --> 02:38:53.000 or the individual PI? 02:38:53.000 --> 02:38:57.000 >>IAN WEISS: So it -- it 02:38:57.000 --> 02:38:58.000 depends if the individual PI is 02:38:58.000 --> 02:39:01.000 the sole person working on that, 02:39:01.000 --> 02:39:03.000 they could be -- they could be 02:39:03.000 --> 02:39:05.000 registered in SAM but generally 02:39:05.000 --> 02:39:06.000 general speaking, it's the 02:39:06.000 --> 02:39:07.000 institution. If you're 02:39:07.000 --> 02:39:09.000 submitting as a business or 02:39:09.000 --> 02:39:13.000 institution, it should be the 02:39:13.000 --> 02:39:16.000 business or institution. 02:39:16.000 --> 02:39:17.000 Thank you, Ian. Next question. 02:39:17.000 --> 02:39:20.000 Is it recommended that the 02:39:20.000 --> 02:39:24.000 proposed task are severable so 02:39:24.000 --> 02:39:28.000 so that it is possible to be 02:39:28.000 --> 02:39:29.000 to be funded partially? 02:39:29.000 --> 02:39:31.000 02:39:31.000 --> 02:39:33.000 >>IAN WEISS: As I said, yes it 02:39:33.000 --> 02:39:35.000 makes it easier to be considered 02:39:35.000 --> 02:39:37.000 if you have a severable type 02:39:37.000 --> 02:39:38.000 contract. Because we never know 02:39:38.000 --> 02:39:39.000 when the funding issues are 02:39:39.000 --> 02:39:42.000 going to be. And when things 02:39:42.000 --> 02:39:43.000 are sever SBL and are kind of 02:39:43.000 --> 02:39:46.000 taken into little bite sized 02:39:46.000 --> 02:39:48.000 pieces it definitely makes it 02:39:48.000 --> 02:39:49.000 able and are kind of taken into 02:39:49.000 --> 02:39:50.000 little bite sized pieces it 02:39:50.000 --> 02:39:51.000 definitely makes it easier for 02:39:51.000 --> 02:39:52.000 the government to consider your 02:39:52.000 --> 02:39:53.000 proposal. So my recommendation 02:39:53.000 --> 02:39:55.000 would be yes. 02:39:55.000 --> 02:40:01.000 >> Thank you, Ian. I don't see 02:40:01.000 --> 02:40:31.000 anymore questions in the chat 02:40:34.000 --> 02:40:35.000 . 02:40:35.000 --> 02:40:36.000 >>DR. KINNERA CHADA: Okay and 02:40:36.000 --> 02:40:37.000 we have covered all the 02:40:37.000 --> 02:40:38.000 questions that we received? 02:40:38.000 --> 02:40:42.000 >> Yes. 02:40:42.000 --> 02:41:02.000 >> That's good 02:41:02.000 --> 02:41:08.000 . Anymore questions 02:41:08.000 --> 02:41:11.000 for BAA team 02:41:11.000 --> 02:41:12.000 ? 02:41:12.000 --> 02:41:13.000 >>IAN WEISS: It is the 02:41:13.000 --> 02:41:18.000 absolutely the easiest time to 02:41:18.000 --> 02:41:21.000 get answers from us is right now 02:41:21.000 --> 02:41:32.000 . So if you have questions, 02:41:32.000 --> 02:41:34.000 don't be shy. 02:41:34.000 --> 02:41:35.000 >> And we have one more 02:41:35.000 --> 02:41:38.000 question. When will the 02:41:38.000 --> 02:41:40.000 recording be available? 02:41:40.000 --> 02:41:41.000 >>IAN WEISS: I think -- 02:41:41.000 --> 02:41:43.000 >> November 21st. 02:41:43.000 --> 02:41:47.000 >> Yeah. 02:41:47.000 --> 02:41:50.000 >> Next Thursday. 02:41:50.000 --> 02:41:54.000 >> Thank you, Kinnera. How will 02:41:54.000 --> 02:41:57.000 will you let us know about the 02:41:57.000 --> 02:41:58.000 the PFAs funding max? 02:41:58.000 --> 02:41:59.000 >>DR. KINNERA CHADA: The 02:41:59.000 --> 02:42:01.000 response would be posted as part 02:42:01.000 --> 02:42:03.000 as part of the meeting 02:42:03.000 --> 02:42:07.000 material. Which would be posted 02:42:07.000 --> 02:42:29.000 on November 21st as well 02:42:29.000 --> 02:42:30.000 . 02:42:30.000 --> 02:42:32.000 02:42:32.000 --> 02:42:36.000 >> Next question: If the budget 02:42:36.000 --> 02:42:38.000 awarded multi-year contract be 02:42:38.000 --> 02:42:40.000 increased amendment in the 02:42:40.000 --> 02:42:44.000 future years? 02:42:44.000 --> 02:42:45.000 >>IAN WEISS: So it -- it can be 02:42:45.000 --> 02:42:48.000 can be. Generally speaking we 02:42:48.000 --> 02:42:50.000 -- we kind of frown on that but 02:42:50.000 --> 02:42:51.000 if there's, you know again the 02:42:51.000 --> 02:42:52.000 nature of research and 02:42:52.000 --> 02:42:54.000 development, we understand that 02:42:54.000 --> 02:42:56.000 sometimes you don't know what 02:42:56.000 --> 02:42:58.000 you don't know until work begins 02:42:58.000 --> 02:43:04.000 so those kinds of things are 02:43:04.000 --> 02:43:08.000 opened negotiation. It's not 02:43:08.000 --> 02:43:10.000 a... we would approve any 02:43:10.000 --> 02:43:11.000 increase in costs but it is 02:43:11.000 --> 02:43:13.000 possible. 02:43:13.000 --> 02:43:16.000 >> Thank you, Ian. The budget 02:43:16.000 --> 02:43:20.000 says subcontracts need detailed 02:43:20.000 --> 02:43:23.000 budget for 200k is that direct 02:43:23.000 --> 02:43:25.000 direct cost or total cost for 02:43:25.000 --> 02:43:26.000 one year or total project 02:43:26.000 --> 02:43:27.000 length? 02:43:27.000 --> 02:43:28.000 >>IAN WEISS: So it would be 02:43:28.000 --> 02:43:30.000 total cost for the project 02:43:30.000 --> 02:43:32.000 length. 02:43:32.000 --> 02:43:34.000 >> Thank you, Ian. Next 02:43:34.000 --> 02:43:38.000 question. Are there any 02:43:38.000 --> 02:43:40.000 restrictions on the overhead? 02:43:40.000 --> 02:43:42.000 >>IAN WEISS: Um, so I don't 02:43:42.000 --> 02:43:45.000 want to get too far into that. 02:43:45.000 --> 02:43:46.000 So the -- the short answer is 02:43:46.000 --> 02:43:48.000 yes, there are restrictions on 02:43:48.000 --> 02:43:49.000 overhead. It's all the same 02:43:49.000 --> 02:43:51.000 restrictions that we have for 02:43:51.000 --> 02:43:55.000 any other government contracts. 02:43:55.000 --> 02:43:59.000 So kind of depends on a number 02:43:59.000 --> 02:44:01.000 of factors but there are some -- 02:44:01.000 --> 02:44:03.000 there are some restrictions on 02:44:03.000 --> 02:44:06.000 that. I could probably provide 02:44:06.000 --> 02:44:07.000 some -- some more guidelines on 02:44:07.000 --> 02:44:10.000 that go along with the MEE 02:44:10.000 --> 02:44:12.000 the meeting materials when they 02:44:12.000 --> 02:44:14.000 are published on the 21st. Not 02:44:14.000 --> 02:44:15.000 really prepared to kind of -- 02:44:15.000 --> 02:44:16.000 that's a whole discussion I 02:44:16.000 --> 02:44:18.000 guess is what I'm trying to say 02:44:18.000 --> 02:44:20.000 there. So I can give some extra 02:44:20.000 --> 02:44:21.000 guidance for the posting on the 02:44:21.000 --> 02:44:23.000 21st to answer that question. 02:44:23.000 --> 02:44:25.000 >> Thank you, Ian. Next 02:44:25.000 --> 02:44:29.000 question: Can you tell us more 02:44:29.000 --> 02:44:30.000 about the review process? 02:44:30.000 --> 02:44:32.000 02:44:32.000 --> 02:44:37.000 >> I think this was covered as 02:44:37.000 --> 02:44:40.000 part of my slide, but I 02:44:40.000 --> 02:44:41.000 apologize once again for the 02:44:41.000 --> 02:44:44.000 for the INTRER RUPGS of the 02:44:44.000 --> 02:44:45.000 audio. It would begin with the 02:44:45.000 --> 02:44:46.000 interruption of the audio. It 02:44:46.000 --> 02:44:47.000 would begin with the concept 02:44:47.000 --> 02:44:49.000 paper where the program leaders 02:44:49.000 --> 02:44:50.000 with the centers and offices 02:44:50.000 --> 02:44:52.000 would be looking at the three 02:44:52.000 --> 02:44:54.000 page concept paper and making a 02:44:54.000 --> 02:44:56.000 recommendation if it should move 02:44:56.000 --> 02:44:57.000 forward for stage 1 review. If 02:44:57.000 --> 02:45:00.000 a recommendation to move forward 02:45:00.000 --> 02:45:03.000 for stage 1 review is made, 02:45:03.000 --> 02:45:04.000 then a panel technical 02:45:04.000 --> 02:45:06.000 evaluation panel would be 02:45:06.000 --> 02:45:09.000 NIRNuated with three or more 02:45:09.000 --> 02:45:10.000 initiated with three or more 02:45:10.000 --> 02:45:12.000 subject matters experts. They 02:45:12.000 --> 02:45:14.000 will look at the full proposal 02:45:14.000 --> 02:45:17.000 and the evaluation criteria has 02:45:17.000 --> 02:45:21.000 been provided in part 4 of the 02:45:21.000 --> 02:45:25.000 BA announcement. The evaluation 02:45:25.000 --> 02:45:28.000 criteria comprises 02:45:28.000 --> 02:45:30.000 comprises of program relevance, 02:45:30.000 --> 02:45:35.000 MERMENT and take into 02:45:35.000 --> 02:45:38.000 consideration any passed 02:45:38.000 --> 02:45:40.000 performance 02:45:40.000 --> 02:45:41.000 Recommendation for panel to 02:45:41.000 --> 02:45:43.000 award or do not award would be 02:45:43.000 --> 02:45:46.000 considered. That is a SPUMry of 02:45:46.000 --> 02:45:47.000 a summary of the review process 02:45:47.000 --> 02:45:51.000 for the application that is will 02:45:51.000 --> 02:45:54.000 will be received 02:45:54.000 --> 02:45:55.000 for FY25. 02:45:55.000 --> 02:45:57.000 >> Next question: If we were 02:45:57.000 --> 02:46:00.000 awaiting a funding decision what 02:46:00.000 --> 02:46:02.000 is your recommendation about 02:46:02.000 --> 02:46:05.000 when to resubmit? That response 02:46:05.000 --> 02:46:07.000 was positive but funding 02:46:07.000 --> 02:46:11.000 dependent should we resubmit 02:46:11.000 --> 02:46:12.000 now or wait until 02:46:12.000 --> 02:46:13.000 December 6th? 02:46:13.000 --> 02:46:15.000 ? 02:46:15.000 --> 02:46:17.000 >> I would say wait until 02:46:17.000 --> 02:46:20.000 December 6th. The full 02:46:20.000 --> 02:46:22.000 proposals aren't due -- 02:46:22.000 --> 02:46:23.000 >> [INAUDIBLE] 02:46:23.000 --> 02:46:26.000 >>IAN WEISS: Yeah I would say 02:46:26.000 --> 02:46:28.000 waiting is -- is the few weeks 02:46:28.000 --> 02:46:30.000 would probably be best. So 02:46:30.000 --> 02:46:31.000 you're not resubmitting and 02:46:31.000 --> 02:46:33.000 then find out that you're 02:46:33.000 --> 02:46:35.000 getting funding. 02:46:35.000 --> 02:46:40.000 >> Thank you, Ian. Next 02:46:40.000 --> 02:46:44.000 question: For FY25, charge area 02:46:44.000 --> 02:46:47.000 3B1A what is 02:46:47.000 --> 02:46:51.000 the an TIS pated for this 02:46:51.000 --> 02:46:52.000 priority area? 250k or more? 02:46:52.000 --> 02:46:53.000 02:46:53.000 --> 02:46:54.000 >>DR. KINNERA CHADA: That is a 02:46:54.000 --> 02:46:57.000 very specific question. So we 02:46:57.000 --> 02:47:00.000 will have to check. And lets 02:47:00.000 --> 02:47:02.000 let us know. Would you say the 02:47:02.000 --> 02:47:04.000 ballpark would be around 250 or 02:47:04.000 --> 02:47:05.000 so, Ian? 02:47:05.000 --> 02:47:10.000 >>IAN WEISS: Yeah, probably in 02:47:10.000 --> 02:47:11.000 that ballpark. 02:47:11.000 --> 02:47:12.000 02:47:12.000 --> 02:47:15.000 >> Thank you, both. Next 02:47:15.000 --> 02:47:18.000 question: For volume of 02:47:18.000 --> 02:47:19.000 appendixes, it asks for 02:47:19.000 --> 02:47:23.000 biographic sketches but then 02:47:23.000 --> 02:47:26.000 also calls for résumés are NIH 02:47:26.000 --> 02:47:28.000 biosketches sufficient? Are you 02:47:28.000 --> 02:47:32.000 looking for pie I don't sketches 02:47:32.000 --> 02:47:40.000 and résumés 02:47:40.000 --> 02:47:41.000 bio dosketches and résumés? 02:47:41.000 --> 02:47:43.000 >>DR. KINNERA CHADA: I would 02:47:43.000 --> 02:47:44.000 defer that question to Ian. 02:47:44.000 --> 02:47:45.000 . 02:47:45.000 --> 02:47:48.000 >>IAN WEISS: I believe it is 02:47:48.000 --> 02:47:50.000 looking for both 02:47:50.000 --> 02:47:51.000 sketches and résumés? 02:47:51.000 --> 02:47:52.000 >>DR. KINNERA CHADA: I would 02:47:52.000 --> 02:47:53.000 defer that question to Ian. >>IAN WEISS: I believe it is 02:47:53.000 --> 02:47:54.000 looking for both. 02:47:54.000 --> 02:47:55.000 02:47:55.000 --> 02:47:56.000 >> Thank you, Ian. Is there a 02:47:56.000 --> 02:48:01.000 policy on using live hyper links 02:48:01.000 --> 02:48:02.000 in proposals 02:48:02.000 --> 02:48:03.000 document? 02:48:03.000 --> 02:48:04.000 >>IAN WEISS: I don't -- I don't 02:48:04.000 --> 02:48:06.000 think we have a policy on that, 02:48:06.000 --> 02:48:07.000 but it's -- it's a good 02:48:07.000 --> 02:48:11.000 question, because it gets into, 02:48:11.000 --> 02:48:14.000 you know, if -- you're using 02:48:14.000 --> 02:48:15.000 live hyper links you're 02:48:15.000 --> 02:48:17.000 presenting more page information 02:48:17.000 --> 02:48:19.000 than the page limit on the -- on 02:48:19.000 --> 02:48:22.000 on the proposals there. So I 02:48:22.000 --> 02:48:23.000 would say that's something we 02:48:23.000 --> 02:48:25.000 should probably discuss 02:48:25.000 --> 02:48:27.000 internally and address if an 02:48:27.000 --> 02:48:28.000 amendment, yeah. 02:48:28.000 --> 02:48:29.000 >>DR. KINNERA CHADA: And I also 02:48:29.000 --> 02:48:31.000 know that some of the reviewers 02:48:31.000 --> 02:48:33.000 do not take into account any of 02:48:33.000 --> 02:48:36.000 the information provided as part 02:48:36.000 --> 02:48:37.000 of hyper links. 02:48:37.000 --> 02:48:41.000 >>IAN WEISS: Yeah. I would say 02:48:41.000 --> 02:48:42.000 it's -- it's an excellent 02:48:42.000 --> 02:48:44.000 question and we need to discuss 02:48:44.000 --> 02:48:46.000 that internally and address it. 02:48:46.000 --> 02:48:49.000 It wouldn't be in tomorrow's 02:48:49.000 --> 02:48:52.000 amendment most likely, but my 02:48:52.000 --> 02:48:54.000 feeling is that live hyperlinks 02:48:54.000 --> 02:48:56.000 probably aren't going to be 02:48:56.000 --> 02:48:58.000 allowed but we should discuss 02:48:58.000 --> 02:49:04.000 discuss that and get back to 02:49:04.000 --> 02:49:09.000 everybody. 02:49:09.000 --> 02:49:15.000 >> Thank you both 02:49:15.000 --> 02:49:17.000 , both. Next question: What is 02:49:17.000 --> 02:49:19.000 the level of feedback provided 02:49:19.000 --> 02:49:21.000 on the concept proposals? Will 02:49:21.000 --> 02:49:23.000 we get feedback on the idea as 02:49:23.000 --> 02:49:26.000 as well as the budget? Related 02:49:26.000 --> 02:49:29.000 recommendations for applying 02:49:29.000 --> 02:49:30.000 the method to a different 02:49:30.000 --> 02:49:31.000 topic? 02:49:31.000 --> 02:49:33.000 >>DR. KINNERA CHADA: It would 02:49:33.000 --> 02:49:35.000 be any of those. The level of 02:49:35.000 --> 02:49:36.000 feedback is minimal. And 02:49:36.000 --> 02:49:38.000 because multiple program 02:49:38.000 --> 02:49:41.000 offices within different 02:49:41.000 --> 02:49:45.000 centers are looking at these 02:49:45.000 --> 02:49:49.000 concept papers they could be 02:49:49.000 --> 02:49:50.000 feedback from that would cover 02:49:50.000 --> 02:49:55.000 all the three areas that the 02:49:55.000 --> 02:49:58.000 attendee has asked 02:49:58.000 --> 02:49:59.000 . Generally, I would say that 02:49:59.000 --> 02:50:02.000 budget recommendations are not 02:50:02.000 --> 02:50:04.000 provided as part of the feedback 02:50:04.000 --> 02:50:08.000 there would only be stating that 02:50:08.000 --> 02:50:12.000 provided -- the review of 02:50:12.000 --> 02:50:16.000 the application is pending 02:50:16.000 --> 02:50:18.000 funding availability. That is 02:50:18.000 --> 02:50:20.000 the information that the office, 02:50:20.000 --> 02:50:21.000 program officers would be 02:50:21.000 --> 02:50:23.000 provided with respect to 02:50:23.000 --> 02:50:25.000 feedback. And please note that 02:50:25.000 --> 02:50:28.000 optional -- feedback is only 02:50:28.000 --> 02:50:29.000 provided for optional early 02:50:29.000 --> 02:50:30.000 concept paper submissions. You 02:50:30.000 --> 02:50:34.000 wouldn't be receiving any 02:50:34.000 --> 02:50:38.000 feedback once you submit an 02:50:38.000 --> 02:50:41.000 application in FY24 -- sorry, on 02:50:41.000 --> 02:50:44.000 on February 24th. And if it 02:50:44.000 --> 02:50:45.000 does not go through stage 1 02:50:45.000 --> 02:50:47.000 review, you will not be 02:50:47.000 --> 02:50:50.000 receiving feedback for your 02:50:50.000 --> 02:50:52.000 concept paper. Feedback is only 02:50:52.000 --> 02:50:55.000 for optional early concept 02:50:55.000 --> 02:50:58.000 papers. 02:50:58.000 --> 02:51:00.000 >> Thank you. Next question: A 02:51:00.000 --> 02:51:02.000 question about the review 02:51:02.000 --> 02:51:04.000 process. For proposals that 02:51:04.000 --> 02:51:05.000 target a specific center, would 02:51:05.000 --> 02:51:08.000 the people from that center 02:51:08.000 --> 02:51:13.000 invited to provide a feedback on 02:51:13.000 --> 02:51:14.000 that proposal? 02:51:14.000 --> 02:51:16.000 >>DR. KINNERA CHADA: Yes. So 02:51:16.000 --> 02:51:19.000 all the applications that are 02:51:19.000 --> 02:51:22.000 received will be shared 02:51:22.000 --> 02:51:24.000 FDA-wide. And based on the 02:51:24.000 --> 02:51:27.000 program leaders who have 02:51:27.000 --> 02:51:29.000 notified our team about interest 02:51:29.000 --> 02:51:31.000 in participating in the BA 02:51:31.000 --> 02:51:33.000 program, they would have access 02:51:33.000 --> 02:51:35.000 to all the concept papers. And 02:51:35.000 --> 02:51:37.000 then they would be reviewing the 02:51:37.000 --> 02:51:40.000 concept papers or they would be 02:51:40.000 --> 02:51:42.000 sharing this with their program 02:51:42.000 --> 02:51:46.000 leaders within their offices 02:51:46.000 --> 02:51:51.000 across their center. Based 02:51:51.000 --> 02:51:53.000 . Based 02:51:53.000 --> 02:51:55.000 on the interest and linement of 02:51:55.000 --> 02:51:59.000 the priorities, they would be 02:51:59.000 --> 02:52:01.000 would be enVIETing additional 02:52:01.000 --> 02:52:03.000 subject experts or reviewers to 02:52:03.000 --> 02:52:07.000 to participate as part of the 02:52:07.000 --> 02:52:14.000 technical panel. 02:52:14.000 --> 02:52:15.000 alignment of the priorities, 02:52:15.000 --> 02:52:16.000 they would be inviting 02:52:16.000 --> 02:52:17.000 additional subject experts or reviewers to participate as part 02:52:17.000 --> 02:52:18.000 of the technical panel. Yes, I 02:52:18.000 --> 02:52:19.000 believe so. I would like to 02:52:19.000 --> 02:52:23.000 confirm with Ian. The question 02:52:23.000 --> 02:52:28.000 is 02:52:28.000 --> 02:52:32.000 : Can the proposal 02:52:32.000 --> 02:52:33.000 include both basic and applied 02:52:33.000 --> 02:52:37.000 research? 02:52:37.000 --> 02:52:58.000 >>IAN WEISS: Yes 02:52:58.000 --> 02:52:59.000 . 02:52:59.000 --> 02:53:01.000 >>DR. KINNERA CHADA: Any other 02:53:01.000 --> 02:53:02.000 questions, Jessica? 02:53:02.000 --> 02:53:06.000 >> So no more questions have 02:53:06.000 --> 02:53:15.000 come up 02:53:15.000 --> 02:53:17.000 . There's one more. 02:53:17.000 --> 02:53:19.000 Resubmissions of last year BA 02:53:19.000 --> 02:53:26.000 proposals will go to the review 02:53:26.000 --> 02:53:27.000 ka? 02:53:27.000 --> 02:53:28.000 >> So no more questions have come up. There's one more. 02:53:28.000 --> 02:53:29.000 Resubmissions of last year BA 02:53:29.000 --> 02:53:30.000 proposals will go to the review 02:53:30.000 --> 02:53:31.000 as well? 02:53:31.000 --> 02:53:32.000 >>IAN WEISS: Yes it goes 02:53:32.000 --> 02:53:33.000 through the whole review process 02:53:33.000 --> 02:53:34.000 again. 02:53:34.000 --> 02:53:35.000 >>DR. KINNERA CHADA: I also 02:53:35.000 --> 02:53:38.000 have a comment from Shaila 02:53:38.000 --> 02:53:40.000 saying that we tend to fund more 02:53:40.000 --> 02:53:44.000 applied research rather than 02:53:44.000 --> 02:53:48.000 basic research applications 02:53:48.000 --> 02:53:53.000 . 02:53:53.000 --> 02:53:57.000 >> And no more questions 02:53:57.000 --> 02:53:58.000 . 02:53:58.000 --> 02:53:59.000 >>DR. KINNERA CHADA: So Ian do 02:53:59.000 --> 02:54:02.000 you want to go ahead and make 02:54:02.000 --> 02:54:03.000 the closing remarks? 02:54:03.000 --> 02:54:04.000 >>IAN WEISS: Sure. I want to 02:54:04.000 --> 02:54:08.000 thank you everybody for your 02:54:08.000 --> 02:54:11.000 time and interest in our BA 02:54:11.000 --> 02:54:13.000 announcement and attending BAA 02:54:13.000 --> 02:54:15.000 day. And thank you for all your 02:54:15.000 --> 02:54:17.000 questions. We have a couple of 02:54:17.000 --> 02:54:19.000 get-backs to get to everybody 02:54:19.000 --> 02:54:23.000 for the 21st. And yeah. Thank 02:54:23.000 --> 02:54:25.000 you very much. It's been a very 02:54:25.000 --> 02:54:29.000 productive presentation, I 02:54:29.000 --> 02:54:31.000 think 02:54:31.000 --> 02:54:32.000 . 02:54:32.000 --> 02:54:33.000 02:54:33.000 --> 02:54:34.000 >>DR. KINNERA CHADA: Thank you,