NARCH PI Meeting NIGMS Update

NARCH PI Meeting NIGMS Update

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SHEILA CALDWELL: So first off, thank you, everybody. Good afternoon, or good morning for some folks, and welcome to the NARCH PI meeting. I am sad that we are not all meeting in person, as I really enjoy our meetings.

But we did manage to figure out at least to do the Zoom, and I think that will be helpful. So just a couple of housekeeping notes. What we're asking, one, is to let everybody know that the meeting is being recorded, that we will keep track of the questions that are posted in the chat box and try to respond them as best possible and hopefully be able to get the recording up on the NIGMS NARCH website at a later date. Two, fairly important, if you are not a speaker and speaking, please make sure you turn your video off.

There is a limited bandwidth, and it really is very helpful with quality of the video for the speaker if others are turned off their videos. And I believe we actually have control over mute buttons. So we'll try to make sure everybody is muted. And again, if you have questions throughout the program, you can actually put those in the chat box. We are going to monitor those questions as best possible to be able to provide the questions to the speakers or, even if it's to us, to be able to respond.

So thank you again, everybody. So as is tradition with our NARCH PI meetings, even though this seems a little nontraditional because of Zoom, we always start with an opening blessing. And we are very fortunate today to have Tam Lutz with us, who's the director of the maternal child health program at the Northwest Tribal Epicenter, part of the Northwest Portland area Indian Health Board, and a member of the Lummi Nation. And she will be providing our opening blessing this morning. So if we could just have a few minutes and allow Tam to provide us with that blessing. Thank you.

I'm going to turn it over to you, Tam. You should be able to unmute yourself. Perfect. TAM LUTZ: OK, great. [NON-ENGLISH SPEECH].

I don't understand all of my language, but I'm going to do my best to talk in my native language, or the language of [NON-ENGLISH SPEECH].. Help us to work together in a good way, inspired by the words of our elders. [NON-ENGLISH SPEECH] the stories, inspired by the stories and the experience and history of our people, [NON-ENGLISH SPEECH]..

Creator, protect those here today as they work in partnership so they may continue their good work to improve the health of our native communities. Creator, protect the students they work with and all native students as they return home, and give them the strength and the inspiration and the perseverance to continue their studies amidst this pandemic. Creator, protect all our families and our communities that we may serve those in need and care for one another in this pandemic and always. As we work [NON-ENGLISH SPEECH].. today, in a good way, we pray. Amen.

PRESENTER: Thank you very much. So I'm really excited. That was wonderful, a great beginning to this meeting. And I want to try to keep us on time as much as possible.

Again, I went over the housekeeping notes. I don't have a lot to add. I'm just very excited about the program, excited that we have some really terrific speakers today.

It will not all be focused on COVID-19, although I know that much of that weighs heavily on us, especially in many of the communities and how hard they are impacted. So we'll have a little bit of both today. Again, just very happy everybody's here.

So I want to get going and started our first speaker up is Dr. Jon Lorsch. Many of you know him as the director of our institute at National Institute of General Medical Sciences. Really excited he's going to be providing some of the NIGMS updates. And again, we're very fortunate that he has been extremely supportive of the NARCH program, always asking me ways in which we can improve it or support it. And I've been very appreciative of that.

So I'm going to let you take over, Jon. JON LORSCH: Thank you, Sheila. Thank you very much. Thanks, David, for the slides.

Welcome, everybody. It's great to be together. But, as Sheila said, it's too bad that we're not in person. But maybe next year.

I wanted to give you some updates on some things going on at NIGMS related to, or of interest, I hope, to the NARCH program. Next slide, please, David. One very important thing is that we are commencing a formal evaluation of the program, which hasn't really been done, maybe since its inception. And the idea is to help the program and find ways to improve the program and better support the health research needs of AI/AN communities.

We are going to inform and consult with tribal leaders about this process through a Dear Tribal Leaders letter. And our plan is to present the evaluation report, once it's conducted, to the NIH Tribal Advisory Committee, the TAC, for input as well as to the NIGMS advisory council. And one thing I just wanted to say related to this is that we intend to continue support for the NARCH program at or above current levels. And I say that just to assure you that the goal of this evaluation is really to find ways to improve the program so it better serves the AI/AN communities and you, the researchers, who are trying to help those communities. So this is really a positive. It's a chance to find problems with the program that you may perceive and find ways to really make it work better.

So I hope that you will be interested in that process and look forward to getting under way with it. Next slide, please. One of the things I wanted to make you aware of in case you weren't is NIGMS' renewed commitment to supporting technology resources that can be used by anyone in the scientific community to forward the goals of their research. So these are shared national or regional facilities that would give researchers access to cutting-edge technologies that they otherwise might not have easy access to. And we have just started a new program to make this easier.

It's the NIGMS National and Regional Resources Program, in which we give what are called R24 grants to groups or organizations that can run these kinds of facilities and provide at least regional access, which is multi-state access, but preferably national-scale access. And we've just given the first series of these awards, and we'll continue to do that. Next slide, please, David.

And what I wanted to just draw your attention to as an example, but also because some of you may be interested in it, is the IDeA National Research-- Resource for Quantitative Proteomics. So this is actually a collaboration between the University of Arkansas School for Medical Sciences and the Oklahoma Medical Research Foundation. They both started out with independent mass spectrometry proteomics facilities that were funded through the IDeA program. And a few years ago, we gave a supplement to these centers in order to merge their center into something that was more efficient, created economies of scale, and could serve more users. And then just this year, we've now given them one of these R24 grants to become a national resource for researchers who want to do proteomics.

And they're actually offering waivers, such that you, if you're an IDeA state, I believe, can get free access to proteomics studies to do pilot studies and get preliminary data, for example. And even if you eventually are paying for this, it's going to be about 75% less, I think, than the cost of comparable sorts of resources. So if you are, for instance, doing a biomarker study, and you need proteomics data and proteomics support, this would be a tremendous resource to make use of.

But this is just an example. And there are others that we are currently starting to fund and will be continuing to fund. So if you are in need of cutting-edge, high-end technology of some sort, please contact your program director, and we can help you find out if there is a resource that's available for you to make use of.

Next slide, please. I also wanted to make you aware, in case you're not, of another program that I thought would be of interest to this group, which is our program in research to understand and inform interventions that promote the research careers of individuals in the biomedical sciences. So this is a funding opportunity announcement to get R1s in this specific area. And what our goal is, is to support research that's designed to test various training, mentoring, and other kinds of initiatives that are trying to enhance research-oriented individuals' interest or motivation, persistence, et cetera, in biomedical research careers.

And the projects are expected to produce research findings that will help guide the implementation of better or improved interventions with those goals in mind and in a variety of academic settings and at a variety of career levels, so anything from, for instance, before college all the way to independent research careers. If you have an intervention program that you think could be really tested in a rigorous way to see if it works, and then the information from that disseminated to let others replicate that kind of model and therefore improve the diversity and strength of the biomedical research workforce, this is a program I hope you'll consider. Hit the button, please, David. Thanks. So the interventions have the practical realistic, and scalable and sustainable across not just one institution, but many if we want these to be disseminated such that they can be used by others.

And they need to be experiments. So this isn't just funding to have a program. It really needs to be an experiment to test one intervention's efficacy or compare two different interventions to see which one works better.

So it could be a randomized controlled trial. It could be a case control or a matched pair design, but some sort of rigorous test of the efficacy of the intervention. So if you're interested in this program, please contact Sydella Blatch. She's shown here. She's the program officer for this program.

And she can explain to you how to apply. Next slide, please. And some potential areas that you could consider investigating would be, again, training programs that you want to test to see how effective they are. You might want to test how various psychosocial factors and mitigation of those factors that are linked to certain outcomes can be explored and, again, mitigated or utilized to your advantage in promoting the kinds of outcomes we're looking for. Navigation of critical transition points or institutional factors, particularly culture at institutions, is something that we're very interested in, how it affects individuals' persistence and interest in biomedical research careers and their ability to succeed in those careers and how the culture might be changed in a positive way to influence those career trajectories.

Next slide, please. Another program that we've just launched that I would really like to make you aware of and ask for your help in publicizing is the Maximizing Opportunities for Scientific and Academic Independent Careers, or MOSAIC, program. So this program grew out of a number of studies, including one done by Kenny Gibbs, who is a program officer at NIGMS, that showed that, over the past 25 years, the number of individuals from underrepresented backgrounds going into and getting PhDs in the life sciences has really increased substantially, close to 10-fold, in fact, over that period of time. So that suggests that something that the system has been doing has actually been effective, at least in regards to producing PhDs in the life sciences who are individuals from underrepresented backgrounds. But what has not happened is that that increase has not translated into an increase in the diversity of faculty at research-intensive medical schools. And so there seems to have been a disconnect between the increase in PhD-level diversity and the lack of increase in faculty-level diversity.

And so that suggested that there was an opportunity for an intervention to promote career transition from the postdoctoral phase to the independent faculty research career phase for individuals from underrepresented backgrounds. So this MOSAIC program aims to do just that. It has two different parts. The first is a post-doctoral career transition award to promote diversity. So this is a diversity-focused K99/R00 award.

And it funds postdocs during their mentored research in their postdoctoral phase, provides them independence, extra mentor attention, and funding so that they have stability to do their research and hopefully can move in more innovative and exciting directions. And then once they attain an independent faculty position, they can transition to the R00 phase, which provides up to three years of funding for their research program as independent faculty. The second part of the program is an institutionally focused research education cooperative agreement aimed at promoting diversity.

This is what we call a UE5. And these awards are being given to professional societies, scientific societies, which will serve as sort of nucleation and coordination centers for cohorts of the K99/R00 fellows. And they will provide additional mentoring, opportunities, structured career development, team building, and other career development activities for the fellows.

So for instance, they will help them during the job application process in negotiating startup packages and other things related to their independent jobs. Then when they become independent faculty, they will help them with mentoring for writing their grants, dealing with perhaps faculty-related issues, et cetera. And hopefully, through that additional network of mentors and advisors and supporters, the fellows, the K99/R00 fellows, will be even more successful than they otherwise would be.

Next slide, please. So we've actually just made the first series of UE5 awards. And they have gone to the American Society for Biochemistry and Molecular Biology, American Society for Cell Biology, and the Association of American Medical Colleges.

Next slide, please. We've also had now three rounds of applications come in for K99/R00 scholars. And we've actually just made, just in the last couple of weeks, the first series of awards.

Next slide, please. These awardees will then be sent to or associated with each of the different UE5s from the professional societies, depending on the K99 fellows' research interests. And again, they will get those additional opportunities to be mentored. One thing that's very exciting to us so far is that in the first three rounds of applications for the K99 fellowships, 75% or more of the applicants were from groups historically underrepresented in the biomedical sciences. And 75% of them are actually female.

Next slide, please. So the idea is that each year, we'll fund an additional cohort of these K99 fellows, and they'll move through the system. Some of them will go on to get faculty jobs and become R00 fellows. Next slide, please.

Again, and again, and one more time. And so at steady state, then, NIGMS intends to fund about 75 MOSAIC K99 and R00 fellows. And that steady state will happen in year 5. The really great news is that 15 other NIH institutes and centers have signed up to participate in the MOSAIC program. And several others are signing on soon.

And so that really shows the broad interest that NIH has in this program and that you don't just have to be working in an NIGMS-specific area now to be a K99 fellow or an R00 fellow in the MOSAIC program. You can be studying a wide variety of different topics supported by these different ICs. Next slide, please. So just going back to MOSAIC for a second, I hope that you will help me and us publicize this program. If you know postdocs who would contribute to the diversity of the enterprise, please suggest that they apply for this. Again, you don't just have to be working in NIGMS' mission areas.

Most of NIH's mission areas at this point are covered. And so encourage them to apply to the program. And if you are in a position in a couple of years to be hiring, I hope you'll start engaging these fellows now, because this is going to be a tremendous group of people that you can bring to your institutions as faculty in the future. Just wanted to end with a couple of fun things that we've been doing or things that we've tried to do to make the period of shutdowns and slowed research progress during the COVID-19 pandemic a little more productive. So we realized early on that many trainees were at home and were not able to go into lab and do research.

And we wanted to provide something to them to have something to do that would be worthwhile and would advance their learning and their careers. And so over the course of the summer and the fall, we held a series of 15 webinars on a wide variety of different topics, everything from culturally aware mentoring to cryoelectron microscopy to infectious disease modeling research to starting your own lab as an early stage investigator. They were very well attended. We had them in real time with Q&As with the speakers. And then we put them now up on our website and on YouTube so that people can go and watch them.

So I encourage you to check them out, see what's there, see if you're interested in some of them, let other people know about them. They're a great teaching resource. They're a great resource for your own personal learning. And I hope the community will continue to make use of them. Next slide, please.

We are also concerned about younger students. And NIGMS, through the SEPA program and other initiatives, has a great interest in students at the pre-K through 12 level as well. And we wanted to do something for all the students, their teachers, their parents who were at home, again, during this pandemic and having difficulty with this virtual learning environment. And luckily, we were in a good position to do something. And that was that we had formed a partnership with Scholastic, the publishing house, to put out a magazine called Pathways twice a year that focuses on basic biomedical research and careers and research. And the new issue was just released in October.

And appropriately enough, it's about superbugs, so viruses and bacteria. It's going to go to-- or it's gone to an estimated 2 and 1/2 million middle and high school students in every one of the 50 states and 19,000 teachers across the country. Scholastic bundles it with their Science World magazine, and so reaches a very broad audience. It contains lesson plans for teachers that map to their curricular standards. So they can use it without deviating from their curricular course. And it comes along with a whole bunch of online activities and videos that you can get for free.

In fact, all of this is free, and you can get it at this website here. So again, I encourage you to check it out. Let any young people, teachers, or just people interested in reading about some cool science to look at it. OK, last slide, please. So happy we have a few minutes to take some questions or comments.

I see that there was a question in chat box. Will there be another round of funding opportunities from MOSAIC to professional orgs? And yes, there's going to be another one, as Alison says. And our hope is actually that there will be at least one more funded, and probably more of a clinical area. The two we have are very basic science, and then we have the AAMC, which is great.

But it would be nice to have at least one in a more broadly clinical area. Sheila, questions? SHEILA CALDWELL: So does anybody have any questions for Dr. Lorsch? This is your chance.

Again, it is easiest to at least-- JON LORSCH: Type in the chat box. SHEILA CALDWELL: Yeah, to type into the chat box, and then Dr. Lorsch can respond. OK. JON LORSCH: All right-- SHEILA CALDWELL: I don't see a lot. But I think everybody's probably taking that in and hopefully taking notes on that so that we can spread the word. I think this is a great program, and we definitely want to see more-- as Dr. Lorsch had mentioned, more

underrepresented applying for these types of grants. So that would be wonderful. So-- JON LORSCH: --little NARCH funding.

Sorry, little NARCH funding continued. Definitely, as I said, we are fully intending to continue NARCH funding at its current or above its current levels. So that should not be a concern. SHEILA: So we have another one. How do the societies and the R00 fellows interface and find each other? JON LORSCH: Oh, so that's a good question. So what we do is we take-- they start off as K99 fellows, of course, based on their scientific interests.

We are associating them with one of those three societies. So if you're a biochemist, you would to go to ASBMB. If you're doing cell biology or tissue engineering or something, you'd go to the Cell Biology Society. If you're doing health disparities research, then you'll probably be associated with the AAMC. And then they set up the programming that I talked about, the mentoring, et cetera.

Again, our hope is that there'll be at least one more society that has a more clinical orientation as another UE5. SHEILA: OK, great. Thank you. And then I see a note in here that we might consider packaging your webinars into USB drives that can be distributed to schools whose communities-- JON LORSCH: Yeah, very interesting. SHEILA: Yeah.

JON LORSCH: I will-- that is a very interesting point, and I will put that along to our communications staff. It seems like that might also be a useful thing to think about for the Pathways magazine and all of its resources. SHEILA: Absolutely.

What proportion of the K99/R00-- I still want to call them kangaroos, I apologize-- applicants were American Indian, Alaskan Native, or Native Hawaiian? JON LORSCH: That's a good question. I'm just remembering the data. So I believe it was on the order of 15%, something like that.

There definitely were some who self-identified as AI/AN, which we are very pleased by. But we would like to see more, certainly. So that's one of the reasons I'm telling you about this, because we'd really like to see more.

But it was a not insignificant number, which pleased us. SHEILA: Great. And then I see, "Thank you for the informative presentation. Would you tell us again where we can find the teaching webinars you mentioned near the end of your talk?" JON LORSCH: Yes. So what I'll do is, as soon as we move on, I'll put that in the chat-- link in the chat box for everyone to find.

SHEILA CALDWELL: Perfect. And they are fun. I have used them for my own children.

All right, perfect. Thank you very much. OK, so we're going to move on to the next-- [INTERPOSING VOICES] SHEILA CALDWELL: We're going to move on to the next talk.

The one thing I would like to mention once again, that if you could make sure that your full name is present when you log in, or you can-- after you've logged in, you can right click on it to make sure your full name is present so that, one, we can make sure we identify all our speakers. So if you could make sure, again, to have your full name present, as well as if any questions are coming in, we'll be able to better respond and knowing who the folks are associated. So appreciate that.

Thank you. So next up is Dr. Ming Lei. He is the director for our division of research capacity building, which the NARCH is housed within. And he has been working with-- we often say wearing two hats. I think this hat has been a much larger hat for him recently-- and working very hard on the RADx program that he's going to speak about in response to COVID-19.

So I'm going to let you take over, Dr. Lei. And you may be on mute. MING LEI: Thank you, Sheila. SHEILA: There you go.

And you can-- MING LEI: Can you hear me? Yes? Thank you, Sheila. I have had the opportunity to interact with several NARCH PIs on a few occasions. But this is really my first time to meet with the NARCH community in one place. So I would first like to say a big thank you for everything you do for the community. And I would also like to join Sheila and all the NIH staff to welcome you to this virtual conference.

And as Sheila mentioned, we are gathering virtually because of the COVID-19 pandemic. And unfortunately, after 11 months, more than 15 million cases, and near 300,000 deaths in the US, we still haven't turned the corner yet in our fight against the pandemic. But hopefully, the upcoming availability of vaccines will be the light at the end of the tunnel. So I would like to give you a brief overview of two major NIH initiatives in response to the pandemic.

And my objective is to highlight the resources and opportunities that NIH provides that may be useful for you. Next slide, please. So at the very beginning of the pandemic, NIH recognized that a critical strategy to understand and control the pandemic is to get adequate testing for the population.

So with significant support from Congress, NIH launched the Rapid Acceleration of Diagnostic initiative in April. The initiative includes four parts or four components. One is RADx tech that focused on developing rapidly developing at-home and point-of-care testing technologies. The second one is a similar, also a technology-focused program, but focused on the technologies can be rapidly scaling up so that you increase the production. So together, those two programs have significantly increased the capacity. The projection is that by the end of the year, the capacity will reach 2 million testing cases per day and, by March, reach to 3.5 million tests per day.

The third program is RADx-rad, which focused on the development of utilizing unconventional ideas and approaches to help control the pandemic. Examples include, for example, waste in water testing and utilizing machine learning and artificial intelligence to understanding the spread of the pandemic. So there are a couple of RFAs are functioning, active RFAs, actually completed RFAs. The award has gone out. Most relevant to our meeting to discussion today is the RADx underserved population.

This initiative or program intended to use linked community-engaged projects to increase the testing to underserved or vulnerable populations. Next slide, please. We all know that many underserved populations or communities, including the AI/AN communities, are particularly hard hit by the pandemic. So this $500 million program specifically focused on address-- to address challenges in this area. So the strategy is to utilize a consortium of community-engaged research projects to understand and implement technologies or testing strategies to enhance testing and also to collect and make use of the data that drives up the COVID-19 disparities so that we can better control both current pandemics and probably for the future. So the initiative is divided into two phases, because we anticipated that the rapid evolution or changing of the pandemic would need some adjustment in our strategy.

So we are currently at the point of completion of the first phase, which NIH has issued 300 million worth of grants to the research community. And the next phase, phase 2, will be launched in next year. Next slide, please. We can skip this one. Go forward. So here is a summary of the awards that have gone out so far.

So in phase 1, altogether, there are 70 awards under four funding initiatives. Two of them are focused on testing projects. One is a $5 million testing project. And another one is $2 million testing project. The third one supports studies to understand the social behavior implications the COVID-19 and the pandemic to the underserved populations. And the last one supports a very large coordination and data collection center.

So the map shows where the award went. And the reason for me to show this is that right in the middle, there is a red star. I'm very proud to share with you, that is one of the $5 million awards that went to the Cherokee Nation, led by Dr. Khan, who is in the audience and will speak later. And you can see it's a very competitive process. And I'm also pleased that a number of our NARCH PIs applied, and we ended up with 1 out of the 30 large testing projects.

Congratulations to Dr. Khan, and we're very proud. On the right the pie chart shows that on the NIH Institute, how many of the awards went to the grant initially supported by the institute. You can see that NIGMS is a major contributor to this initiative. We are one of the three or four institutes has the largest share of the award. And altogether, we have nine of those. Next slide, please.

And here shows-- this diagram shows how the overall project will operate. On the right, you can see the project 1 through 4, indicating the individual project. And those projects will interact with the data collection and the coordination center in terms of operation as well as data management. And the data, once it is deidentified, all the personal information will kept in an NIH-wide infrastructure for future use.

And NIH, during this process, has gone through several rounds of consultation with tribal leaders. And we have assured-- requested the Data Coordination Center at Duke University to work closely with the AI/AN community to ensure that the data integrity and ownership is well managed throughout the whole process. Next slide, please. So as I mentioned that phase 1 is completed, but phase 2 is coming. So I would encourage everybody to pay attention to that. The middle line is the NIH website.

Obviously, you can find the website for the RADx programs. You can find information from there. But if that is too tedious-- actually, the website may not be that friendly, as you will find-- then just follow our own home-cooked communication. We have at least three sets of sources. The DRCB, our division, now sends out to all the PIs a weekly update.

We'll definitely update you on the upcoming information. And NIGMS has a very active and effective Twitter handle. And we also publish feedback loop posts for important news.

So we'll definitely highlight information when they are available. So pay attention to that. Next slide, please. The next major initiative I want to briefly introduce to you is the active initiative that focused on therapeutic and vaccine trials. And I'm going to focus down the therapeutics trials.

I think my friend Dave Wilson will talk more about the vaccine trials. So this is a very large initiative. It is actually a public-private partnership, including 8 government agencies, 20 industrial partners, and 3 nonprofits. So on the government side, basically, you can see there is CDC and FDA, NIH, VA, and also, very importantly, this operation Warp Speed, with a very heavy focus on dealing with the pandemic.

So next slide, please. So up to this point, the active initiatives have launched five sets of therapeutic trials using different agents from different sources and managed by different academic institutions or contracting agencies. Overall, it is coordinated by the NIH Foundation. But it goes through the NIH Foundation connect with the PIs or sites that are interested in joining those trials with the protocol leaders, protocol directors at each academic site.

And then once they are vet through the site, get a sort of a certification, then you can join the trial. So so far, as I mentioned, there are five sets of trials and with multiple agents in various phases of clinical trials. Next slide, please.

So again, this is a resource slide. You can find all sorts of updated information from this website. But again, next slide, please, if you find that is not effective, just write to Sheila, and Sheila will help you connect with our contact person at the NIH Foundation, Dr. Stacey Adam. So with that, I hope what I provided is useful to you.

And thank you. I'm happy to answer any questions. SHEILA CALDWELL: Hi, Ming. We actually have several questions going in the chat box. So let me read them.

So will phase 2 focus on vaccination, the outreach to address vaccination hesitancy about AI/AN populations? MING LEI: Great. Great questions. So the RADx initiative is operated under a congressional mandate testing. But we will-- while we are still in the planning phase of phase 2, I think there is a general consensus that phase 2 does need to address vaccination. So the answer to your question is a yes.

Stay tuned for more details on that. SHEILA CALDWELL: All right. Mary Swick did want to let us know that Hopkins did receive a RADx-UP for testing efforts with Navajo Nation and White Mountain Apache tribe. So I'm assuming through maybe their NIMHD award.

So the next question is, have phase 2 awards been identified? MING LEI: Two awards? Meaning? SHEILA CALDWELL: Have phase 2 awards been identified? MING LEI: Oh, no. SHEILA CALDWELL: No. MING LEI: OK.

So but I want to thank you, Sheila, actually, for the first question, reminding me to share with everybody that the AI/AN community was a very significant focus in phase 1. While one of the awards, as I mentioned, went to Cherokee Nation, to Dr. Khan's group, there are actually seven large awards.

All have-- the Hopkins award, as mentioned, actually has an exclusive focus on the AI/AN community. But altogether, there are seven big awards with varying degrees of significant focus on AI/AN community. So thanks for the reminder. The second point is the phase 2 award, no, it has not been identified. It is going to be another round of competition. SHEILA CALDWELL: OK.

So is there a list of funded institutions or projects for the RADx-UP? MING LEI: The answer is yes. Information can be found on the website I shared. But we can make that available to you after the meeting. SHEILA CALDWELL: And I see-- yeah.

Behrous actually put the link in the chat box. So that's wonderful. Thank you, Behrous.

So both of those, both the RADx-UP awards, also the RADx-tech awards. MING LEI: Great. RADx-tech awards are all contracts.

There was one of the senators' named in Shark Tank. So that was-- that name was carried on. So it's through a Shark Tank approach, Holcomb contracts.

SHEILA CALDWELL: Yeah. And I will say there's one other program, the SEAL program, which is being conducted out of NHLBI and NIMHD, with several of us from different institutes involved, looking at some of what you had raised, Sohail, which is the hesitancy behind participating in vaccine trials or actually being vaccinated. So the SEAL program is actually looking at that in ways which the community can be engaged and reduce that distrust or hesitancy within many of the underrepresented or underserved communities. So there is a program being funded out there.

They have picked-- they are working with, I believe it's 11 states which, at that point in time, were the ones that were hardest hit by the COVID positivity. I believe-- we had a meeting the other day that they are talking about increasing the number of states participating and looking at that. So that's a very good point. And NIH is trying to address that, as we know that's also an issue. MING LEI: All right.

But the wording they used, currently, they focused on hot spots. SHEILA CALDWELL: Hot spots, yes. MING LEI: Another important point I want to share is, we are part of that program as well. A number of our NIGMS-supported IDeA programs are leading two or, actually, three states' efforts. And on the program staff side, Sheila is our representative on that group. So any questions, you can write to her.

SHEILA CALDWELL: Terrific. Well, thank you very much. Appreciate that.

That was a wonderful discussion. We're going to move on to our next speaker. And next up is Dr. Dave Wilson. Dr. Dave Wilson, many of you know, is the director of the Tribal Health Research Office. He is also, as well as Dr. Lei, working

very hard in addressing the issues around COVID-19 in the different communities. Obviously, Dave's focused on AI/AN. And he is going to talk about some of the vaccine trials in regards to the tribe. So thank you, Dave. DAVE WILSON: Absolutely.

Thank you, Sheila, for the invitation. It's a pleasure to speak with everybody. So I'm going to see if I can confuse everybody just a little bit more about all of these different things that are going on. Next slide, please. So Dr. Lei talked about the-- or actually, Sheila talked about the SEAL effort and the 11 states that are targeting on hotspots.

Well, I think pretty much now we can consider all 50 states as hotspots. So it would be great to be able to expand that effort. The NIH is-- and we've been coordinating our office-- the Tribal Health Research office has been coordinating a multitude of efforts across the agency, one of them being the RADx-UP, the other being the Coronavirus Prevention Network. And also, NIAID has specifically been working with us on also the SEAL effort. And so I'm going to talk a little bit about this. But I also wanted to address the question around vaccine hesitancy.

So currently, our office, in collaboration with the CoVPN, the Coronavirus Prevention Network, we're currently developing materials to help address some of that vaccine hesitancy. And I know that some of that work is also going on within the SEAL program. So there's a lot going on. It's an immediate need right now because of the EOAs that have been-- one of them has been issued and the others that are currently in process. Next slide, please. So today, I'd like to talk to you about how our office is really assisting tribes with understanding more about all the different opportunities to help them and their communities combat COVID-19.

It is just a burning issue. There's a lot going on. We're hearing more reports about the tribal leaders' concerns about loss of culture because they are losing more and more elders as the pandemic continues to get out of control.

And so we've heard a lot. So this is a picture that my little brother took who works at the Navajo Nation Museum. And there's been a lot of concern about why people have to have restrictions and why the president has been putting restrictions on that community.

And so he saw one of his neighbors, who wrote this message out there. And he thought-- he took a picture of it because it's really true. The physical distancing is such a critical part of reducing the spread, and we're really trying to communicate that message, along with all the other emerging research that's going on across the agency and, actually, across the world related to COVID-19.

Next slide. So our efforts really began early on. As Dr. Lei talked about, we were in the RADx funding

opportunity. We held a rapid response consultation. Usually, our consultations take around six months to execute.

And we were able to do this in a two-week time frame. And it was extremely fast, extremely daunting, but it was great because we got it done. We got a lot of very valuable information that we were able to pass along to the RADx group that they implemented in these funding announcements. And I think that we had really good representation on the number of grants that were funded in RADx-UP. So not only we were involved in that, that was just the beginning of our engagement with these different opportunities. Next slide, please.

So as many of you are aware of that there are currently six vaccines that are in late-stage clinical trials. One of them that has been getting a lot of attention is Pfizer. But Pfizer is actually kind of an outlier. They're not intimately involved in the governmental process. Even though they were funded to produce large quantities of their vaccine product, they haven't been funded in the developmental process, in the clinical trial process.

So I highlighted them here so folks know that they're kind of an outlier. They've done their own thing. And they did a really good job of actually engaging with the Navajo Nation. So they worked out an agreement where a study was sponsored on Navajo. And that study has actually-- we've been reflecting back as part of the CoVPN leadership team and seeing actually the diversity numbers within this particular effort has really been indicative of a successful phase 3 clinical vaccine trial.

And their data-- their diversity data is actually located on their website. So we've been getting updates about the increased numbers of AI/ANs participating or signing up for this particular effort. And our goal is to try to expand those numbers and those opportunities to other tribes and other trials that are currently emerging or in process.

It's also really important for us to talk about what we've been-- what are some of the cold chain requirements. I think those have been critically important for a lot of communities. So that's why we've put all of these up here is to actually go through these one by one with the communities and talk about how each of these work, how the different platforms function, because that has always been a question-- what's in the vial. What's in the vial, and how does it induce protective immunity for us? And so we've been going through not only the mRNA platforms, but also the adenovirus vector platforms and also the protein platforms within a lot of different communities who've requested this technical assistance. Next slide, please. So how we've really been working in this, as you can see, our office has been really positioned right in the middle here working side by side with the Coronavirus Prevention Network.

And we've been partnered with all of the different HIV vaccine trial networks and the infectious disease clinical trial networks. All of these groups have been long established, and they've been providing us a tremendous amount of great past our best practices in terms of community engagement. And also, we've been sharing with these groups important areas of tribal engagement. So it's been, I think, a back-and-forth dialogue on how to best do this to ensure that communities are included, that they feel welcome, and that we're answering all the questions that they need and producing materials that are beneficial to the leaders in these communities to go out and not only advocate for these trials, but also to clarify a lot of the misinformation that's out there. Our office is working quite effectively with Operation Warp Speed.

So we've been working with them. They've been also connecting us with the sponsors. So we've worked a lot with Novavax and Sanofi and, to some extent, Moderna. So it's been a really, I think, effective partnership across the board. I have participated on the expert-- the native AI/AN expert panels that have been put together or assembled by the Coronavirus Prevention Network. This is a group of academics from across the country who provided guidance on not only the research protocols before we were providing them to tribal communities, but also the communication materials that were being developed as a part of this effort, making sure that they were culturally appropriate, and the messages that they were trying to communicate were effective for each of the different communities.

So our ultimate goal here is to respond to the requests of tribal nations and to also include any trusted research partners on them if they would want to bring in a research partner into these conversations. And our ultimate goal here is in the blue bubble that you can see in between the tribal nations and clinical trials is we really want just to provide an opportunity for the tribes to be able to exercise their sovereign rights and make that decision on whether they want to participate or not in these trials. And so that has been our underlying and overall message as we engage these tribal communities, to make sure that we're not using numbers as a metric.

We're really looking at the numbers of tribes that engage us and the number of meaningful conversations that we're able to have with them. Next slide, please. So a big part of this, I think, is really being able to translate what this virus does and what it means and how it confers infection. And it's been really great-- next slide-- to get a lot of, I think, really cool images that we could share with the community and talk about and make these into more translatable analogies.

So what we've been talking about is the coronavirus and its landing gear, which is the spike protein. The spike protein, as it comes in contact with the ACE2 receptor, then begins its invasion into our cells and creates infection and takes over those cells and begins to replicate virus. And so using these analogies and thinking about the landing gear and talking about how each of these vaccines-- next slide, please-- how each of these vaccines actually produces the same result but in a very-- in a slightly different mechanism, thinking about these, the mRNA vaccines where the transcripts are directly injected intramuscularly, and then our machinery actually translates that instruction sheet to produce the spike protein.

And then thereby, the production of neutralizing antibodies occurs, and then using the adenovirus platform and how that is injected into our arms, and it begins the transcription and translation of the spike protein and also leads to the same result as the neutralizing antibodies. We didn't get too much into the specifics around T-cell immunity. That's a little more complicated. So we really stuck to what you see here and describing what is in-- how these actually work.

And then the protein-based platforms like Novavax and Sanofi-- these particular platforms, they're rolling out a little bit later. So Sanofi was supposed to roll out in mid-December. It looks like their launch date is going to be like more in January. But that is because of the complexities around producing massive amounts of stabilized peptide and being able to put this in purified form and into vaccine. So those are coming. And these are trials that tribes have actually really been interested in hearing more about.

Next slide, please. Again, the end game here are the production of neutralizing antibodies will bind up that landing gear so that that spike protein is not able to come in contact with the ACE2 receptor in our bodies, and it will not induce, or it will actually reduce the severity of illness that is caused by COVID-19 infection. So there's a lot of questions that still need to be answered through research. We don't know yet if people who get the vaccine, if immunity equals resistance in terms of their inability to transmit the virus. So say that they're immunized. They come in contact with the wild-type virus.

Their body immediately recognizes it and ramps up the production of antibodies. During that ramping-up phase, are they still infectious to people around them or in their household? So these are really important questions that we still have to answer. And this is really important for multigenerational households, as many tribal communities are or tribal households are.

Next slide, please. Another really important question that we've had to answer-- click one more time-- is the question about-- one more time-- is that if I get the vaccine, will I get infected with the virus? And absolutely not. When we have to put this in simple terms, if you produce a million tires, that you will never be able to produce a fully functional and drivable car, same concept applies to the development of these vaccines.

The spike protein here is the primary factor that's being overamplified. And it doesn't matter how many spike proteins that are developed, you will never be able to create a fully functional and infectious virus particle. Next slide, please. Next slide. One more click.

There we go. So I did talk about this is readily available on the sponsors' websites, the diversity numbers. And here, you can see that within this 42,000-participant study, AI/ANs are included in this 3%. And in all reality, it was numerically a very, very small number. I believe the number was 175.

And this was the very first study to roll out. There were a lot of challenges around the farm-- or the sponsor recognizing the importance of diversity within these trials. They actually had to delay their enrollment so that they could provide more opportunities to increase the black and African-American population within this study, because this was not only monitored and heavily monitored by the NIH, but it was also monitored by Congress. And we were asked to provide quarterly updates on the status to all the different caucuses in Congress about the diversity of each of these different trials.

And if we weren't-- and if these trials weren't diverse, why not? So it was a really important conversation, led to a lot of significant changes in how these companies thought about diversity and inclusion in terms of the trials. Next slide. So these are-- actually, these are slides that we can skip. I just wanted to convey some of the complexity that some of the communities are asking. You know, some of the communities that have really been asking really in-depth and detailed questions about the mechanics of protection. Next slide.

And so this is something that we shared with some of the tribes around they wanted to know specifically how the mRNA vaccines worked. And so to provide cartoon slides like this was really important for them to get that understanding. Next slide. So here is the Pfizer study.

The Pfizer study, again, I talked about. It has currently one of the better examples of diversity and inclusion in terms of its participant pools. And we're hoping that we are able to increase these numbers. Again, we're not-- that is not our metric of success.

But it would be great to see more tribal community members getting involved and being involved in the research process. Next slide. So today here, you can see that I put all of the blue-- all the IHS service areas in blue are the ones that we have provided technical assistance to and are currently pursuing COVID-19 therapies or vaccine participation or trials.

Well, I think one of the great successes that we've seen is in the Great Plains that we have two clinical trials being set up, one in Rapid City and one in Eagle Butte. So Monday morning-- are actually, sorry, Monday afternoon, we're having a closed meeting with three tribal nations, Spirit Lake, Cheyenne River, and Oglala Sioux. So all of the tribal councils of these three nations have come together. And we've been able to get Dr. Tony Fauci to directly engage with these tribal leaders to talk about the importance of these clinical trial opportunities in their communities and what it means and how these can benefit their community members, their participation in these trials. But also, we've been able to include the ACTIV-2 monoclonal antibody studies in collaboration or in conjunction with these vaccine trials.

So it's basically providing a menu of opportunities for tribal members to participate in efforts around COVID-19. Next slide, please. So something else that we're doing is sharing the websites that we have out there. This is one that we really rely heavily on. It's a great website.

There's a lot of videos that are being produced and archived. And we're continuing to do this. A lot of this now is shifting around we're thinking more about implementation studies and implementation science as the conversation begins to shift towards vaccine uptake. And so the questions around-- Dr. Khan had brought up about around vaccine hesitancy,

those issues are critically-- they're paramount for success for tribal members, feeling comfortable and receiving the vaccine once it's available. As Dr. Corey, who leads the Coronavirus Prevention Network, says, vaccines don't save lives. It's the vaccines that go into people's arms that saves lives. And that's the important thing that we've been conveying to all the tribes that we've been engaging with. Also, I wanted to let everybody know-- next slide, please-- is that here is our contact information.

Here is our Facebook page. Later this afternoon, we're going to have an announcement that on Tuesday afternoon, I will be doing a Facebook Live event with Dr. Fauci. And we're going to be answering a lot of questions. So through all of these different efforts-- RADx-UP, CoVPN, NIAID, SEAL-- we've received a lot of really important questions from the communities. And Dr. Fauci has taken the time where he's going to answer a lot of those for us.

So if you're available, and if you're able to, please check in. It's only a 30-minute time slot that we were able to get him. But I think that we're going to cover a lot of ground in that time. So with that, I want to thank you for the opportunity to talk about what we've been doing for vaccines and therapies related to tribal communities. And I will turn it back over to Sheila. SHEILA CALDWELL: Great.

Thank you, Dave. That was wonderful. We do have a few minutes if anybody has any questions.

I can tell you Dave and his office have been wonderful about coordinating a lot of the information across these different silos, making them so they aren't silos, and approaches, because I end up on a lot of committees with Dave. So he's been there. That is for sure. And it's been great, because I think that a lot of being able to discuss and focus on the underrepresented communities and making sure the AI/AN communities are provided a front seat in some of these discussions, I think, has been really helpful.

So I am happy to look in the chat box and see if there are any questions. So what is the date and time for the live Facebook with Dr. Fauci? DAVE WILSON: So it will be Tuesday, December-- I believe it's 14th. I'm losing track of my days, so it's next Tuesday at 2:00 PM Eastern.

SHEILA CALDWELL: OK. And then Sohail wrote, please share either link so we can pass it along. Which link are you thinking about? If you could type it in-- are you looking for the links on some of the vaccine trials? Oh, the call with Dr. Fauci, OK. So yes, so the link is-- Dave, is that at NIH Tribal Health? Is that the-- DAVE WILSON: Yes.

SHEILA CALDWELL: So yes, so I guess you have to be, one, familiar with Facebook, which I'm not. And two, it's at NIH Tribal Health. DAVE WILSON: Yeah, well our Office of OCPL is currently finishing up the final advertisement. And once they do, we'll send it to you, Sheila, and you'll get-- SHEILA CALDWELL: OK. So there is a question, "Do people who get vaccines still have to wear face masks, since the data about their ability to infect others is not yet available?" DAVE WILSON: Absolutely, yes.

And this is a critical message that we want to convey next week, not only to the Great Plains, which is, as their collaborators put it, they're completely on fire right now. You know, you just can't go anywhere without coming in contact with the virus. So it is a message that we want to convey that it is not going to be a silver bullet, because they will roll out in different phases. Some of the people who are in households may be eligible because of underlying conditions to receive the vaccine earlier. But that doesn't mean that everybody in the household will be protected.

SHEILA CALDWELL: OK. Once IRB approval is obtained, participants who received the placebo will be able to receive the vaccine. I think that might be a question. DAVE WILSON: So yeah, that is a current conversation that's happening daily within the coronavirus, but also within Operation Warp Speed, is when do we call it and make that decision. There are a lot of missing bits of information that still need to be obtained through research, because we don't know the durability of the vaccines. We don't know how long they produce protective antibodies in our systems.

We don't know if there are strains that are out there that may tweak the landing gear in a way that the antibodies don't recognize it. So there's a lot of unknown questions that we still have to answer. And that will only come through research, so it's really important to think about that. Something else that's really been important and a good conversation, so Dr. Lei put up here about children and vaccinations. Tony will talk about that, that there's going to be safety studies that are going to be launching soon that include children.

But they won't be efficacy studies. So they're going to titer down the dosages of vaccine in children and see what is the minimal amount of vaccine that will produce a predictive response in children and then be able to bridge the results that we've seen from 18 and above to the children and then make a decision then on approval or not. SHEILA CALDWELL: So Brian did comment that he's very pleased that you put a very large Alaska in there. So put that on the map.

So we have another question. How often should individuals get tested after receiving the vaccine? Should we follow the CDC guidelines? DAVE WILSON: So the best thing now is to follow CDC guidelines because you just don't know when you're going to come in contact. And everybody's through science, we've seen that aerosolization of the droplet particles is the fastest way and the most effective way to get the disease. So it's not so much through touch contact. It's a lot more through inhaling aerosolized particles. So if you're ever in that situation, it's really-- you should think about getting tested.

SHEILA CALDWELL: Yeah. And so Sohail had mentioned, again thinking about the post-vaccination vigilance and looking at any ill effects within-- right now, of course, we only have the data for up to two months, which is for obvious reasons, but really keeping track of that for even longer. Typically, most ill effects are seen within two months. But yes, there's always a possibility after. DAVE WILSON: And it's also important to think about, too, that these new-- these mRNA vaccine platforms, there is nothing out there that has been previously approved under the FDA.

So these are all brand new technologies that are being employed. So we don't know if there are any kind of lingering or long-term effects that may result from these vaccines. That has to be monitored closely. SHEILA CALDWELL: Right.

Very good point, Dave. And then Yvette had written, "When do you anticipate your educational materials about the vaccines will be available for use in Indian country?" That's a great question. DAVE WILSON: Yeah, so we met last week for the first time. And we're moving as fast as we can.

So there's a lot going on. We've included our Johns Hopkins partners in these conversations as well, because they have been so effective in the materials that they've been producing for Navajo and for White Mount Apache. SHEILA CALDWELL: Yeah. DAVE WILSON: So yeah. Yeah, so we're really pushing Dr. Rubidoux.

So hopefully as soon as they become publicly available, we'll definitely let everybody know. SHEILA CALDWELL: So there's another question. Can you share with the group what are the co-occurring conditions were also recruited in the phase 1 and phase 2; i.e., HIV, diabetes, and cancer? DAVE WILSON: So that's a really good question. Early on, the sponsors were actually considering not allowing individuals with HIV to participate.

And it was through extensive engagement and pushback from the HPT and networks that I talked about that they made a clear justification that people who have their condition under control, and there are no detectable virus levels or loads, they have an underlying condition, so they should be included in these trials. So they actually modified their protocols to include individuals with HIV. Diabetes has been a cohort that has been looked at and also respiratory illnesses.

And I don't know if individuals with cancer-- I think that that is dependent upon the stage and how immunosuppressed their systems are due to the cancer. So yeah, we haven't-- I don't think there's been enough inclusion in that area yet. SHEILA CALDWELL: Yeah, I would agree with you on that. Another question, how long does it take for immune response to occur after each shot? DAVE WILSON: You know, that's a great question, and I don't know that.

I have-- SHEILA CALDWELL: That's one for Dr. Fauci, I think. DAVE WILSON: Yeah, that's right. He has-- SHEILA CALDWELL: Right. And I think it's important, actually, to emphasize here that you really need the second shot in order to really fully get that immune response.

So one shot is not going to do it. And you know, I think that's an important message out to the communities that the necessity for those two shots with most of them, actually, is going to be pertinent-- DAVE WILSON: That's right. SHEILA CALDWELL: -- that they get themselves back in there for that second shot so they really do have immunity, because it's not necessarily that they will have maybe a reduced immunity with just one shot they may not have any immunity with just one shot, or so small that it's really not beneficial. DAVE WILSON: Yeah.

Best-case scenario is that the first shot will produce 50% protection, and then the second shot produces the 95 level that we've been hearing about in the news. And the Johnson-- the Johnson product is the only one that they're looking at as a single-dose vaccine. SHEILA CALDWELL: Right.

And again, that's best scenario. So you don't want to be the worst scenario, where you only got 20% on the first shot. So we emphasize please, yes. DAVE WILSON: Well, you know, something else, the messaging that we've been delivering to a lot of tribal communities, that you have to think about the percentages.

Would you rather have a coin-toss chance, a 50-50 chance, of developing severe disease, being intubated, and possibly dying from the disease, or going back a second time and being 95% protected from thinking about going through those adverse events? You know, it's really-- I think it's an easy choice to make when we lay it out that way. SHEILA CALDWELL: Right, absolutely. And then another question, what happens if the second shot is not received? Will the regimen have to start all over again? DAVE WILSON: And that-- yeah, that, I don't know. I don't know what the distancing is. SHEILA CALDWELL: Yeah.

I got the impression from some of the data that, depending on how far out it wasn't, then yes. DAVE WILSON: Yep. SHEILA CALDWELL: And let's see. OK, I believe that's about it. Yeah, so one more comment-- one awareness that could be shared is a comparison to current standard vaccine series-- Prevnar, for example-- is a series to produce full protection. Yeah, that's a very good point, sort of comparing it to some of the other vaccines that are out there that are multi-series vaccines.

So that's a very good point. Dave, I want to thank you. I think that everybody really enjoyed this talk and very much appreciate your efforts out to the communities on these. And I think it's definitely impactful. So it's very much appreciated. Dave's not going far.

He actually ends up on the panel later on today. But I do want to thank him for presenting this. We do have a five-minute break. We're actually five minutes behind schedule, which I actually consider phenomenal for us.

So I will say let's take that five-minute break and come back at 2:55 for any of those. I realize that we are all most likely working from home, but I think we still need bio breaks. And so please go ahead and do that and plan to be back here at 2:55.

I'm very delighted that we have two speakers f

2021-04-13 12:02

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