Panel: Overview of SEED Funding at NIA and NINDS (with Audio Descriptions)

Panel: Overview of SEED Funding at NIA and NINDS (with Audio Descriptions)

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I just want to welcome everyone to the panel today. Thank you so much for joining us virtually. Wish we could see everyone in person, but unfortunately, we're here virtually. So today we're going to talk about an overview of the SEED funding that's available from the National Institute on Aging and the National Institute of Neurological Disorders and Stroke, as well as provide a brief overview of some of the different programs that NIH has available, more broadly. My name is Stephanie Fertig. I'm the HHS Small Business Program lead at the National Institutes of Health.

And today I'm joined by Todd Heim from the National Institute on Aging and Natalie Trzcinski from the National Institute of Neurological Disorders and Stroke. And so we're going to take some time today to, again, briefly present some of the funding opportunities and different opportunities that we have, as well as answer some of the questions that you might have about those different opportunities. I encourage you to put your questions in the Q&A feature that's located in Zoom. I'm sure at this point, all of us have been on a couple of meetings, maybe one or two.

And so there's a great Q&A chat bubble that's below in your Zoom platform. So please put your questions in the Q&A, and we'll be addressing those questions at the end of our talks. So with that, I want to make sure there's plenty of time for the Q&A and for our comments. So I'm going to put myself unmute and ask Carly to please pull up the slides. OK, wonderful. I see the slides, so no technical glitches yet.

Always a great beginning to a virtual conference. So again, my name is Stephanie Fertig. And today, I'm going to provide a brief overview of the Small Business Programs, and then turn it over to both Todd and Natalie.

So here at the National Institutes of Health, we really utilize the Small Business Programs to help take those great innovations and put them into the hands of the clinicians, patients, researchers, and caregivers that need them. So we really see the mission of the Small Business Program as turning discovery into health. Some of this may be a review for many of you, but I think it's still important, since we do have some individuals who may be a little less familiar with the program. There are actually two programs, the Small Business Innovation Research and Small Business Technology Transfer programs. Overall, that's about $1.2 billion dedicated funding for small businesses to do research and development.

That's a significant amount of money. Now one of the myths-- and this is one of the things I am going to do today, is what I affectionately call little myth busting. One of the myths or one of the misconceptions people have is, what are the differences between the SBIR and STTR programs? The big difference between the two is that the SBIR allows partnering, but the STTR requires partnering with a nonprofit research institution.

That's the big difference. All the policy differences between the two really fall out from that main difference between the SBIR and STTR programs. So it isn't one of scope, actually.

The scope of the two programs are often similar. They're reviewed in the same review panel. So they are very similar programs, but there is that difference. Next slide.

So often when we're talking about SBIR and the STTR programs, or the Small Business Programs, we do tend to just default to SBIR. I try not to. But do bear in mind, when, you're talking to many of us, that's, I guess, a bad habit that we may have. Now, this is the largest source of early-stage capital for life sciences in the United States. I say that it's kind of free money, and that it's not alone, and it's non-dilutive. We don't take a piece of the company when we support through the SBIR and STTR program.

There are specific data and intellectual property protections in place. And many of our awardees really do leverage this funding to bring their technology to an inflection point or to the market. Now, that inflection point is often further investment by a third-party investor or company partners. So really, we know that, oftentimes, the Small Business Program may not, in every case, take something to market. But it's that inflection point that can be very important, de-risking that technology, de-risking that product with the SBIR or STTR funds.

So I could spend a lot of time on this slide, but I'm really going to focus on a couple of really important points. There's a number of ways that companies can come in to the program and utilize the program. And different institutes and centers do use the Small Business Program in different ways to meet their mission, and meet the needs of their scientific community, and of their patient community. So one of the misconceptions that are out there is, what is the definition of a feasibility study? So when you see a Phase I SBIR or when you're going for a Phase I SBIR, what does that really mean? Well, that's a feasibility study. But one person's feasibility study is another person's further research and development.

Here at NIH, we don't really clearly define feasibility study. It's a flexible definition. So while a Phase I SBIR may be a feasibility study, and the Phase II SBIR is full research and development, we don't clearly define those. I will tell you that Phase I and Phase II in the SBIR and STTR programs doesn't have anything to do with clinical trials phases. That's an unfortunate similarity in the nomenclature.

So just because something is a Phase I it doesn't really tell you a lot about exactly where it sits within the product development pipeline. We also have something called a fast-track that allows companies to come in in Phase I and Phase II at the same time, so in one application, to reduce some of the time-delay between the Phase I and Phase II, and the review. Keep them from having to submit an additional application for the Phase II. We also have something called the Direct to Phase II. Now this is just for the SBIR program only, for those companies that may have already done the feasibility work, already done all of that work, and they can jump directly to a Phase II. Now, regardless of how a company gets to the Phase II, either through the more standard phase processes, or through a fast-track, or Direct to Phase II, many institutes and centers, including NIA and NINDS, has something we call a Competing Renewal or Phase IIB.

There's a real recognition that even when you get to the end of a Phase II, you may not be ready for the commercial market or even that inflection point. You may need additional time and funds. And that's where the Phase IIB comes in. It gives you that additional research and development that might be necessary.

We also have something called the Commercialization Readiness Pilot, or CRP. And again, that provides additional business and technical assistance to help bridge some of the gaps that might be between the Phase II and that commercial market or inflection point. Now, both NIA and NINDS participate in these programs, but they do use them a little bit differently. And so that's one of the reasons why it's really important to reach out and talk with programs [INAUDIBLE]. Talk with your program officials. Talk with us before applying, before submitting.

So if you have any questions, we are here, really, to answer those questions. And we are here to help you navigate the process, particularly if you are new. And I understand there might be a couple of companies who are fairly new to the SBR and STTR programs.

Even just navigating that Phase I, versus Fast-Track, versus Direct to Phase II, again, program staff can help talk through and help you determine what might be the best way for you to enter the program. One of the other big myths that we have that I often hear is around budget. So you'll see the SBA, the Small Business Administration budgetary guidelines here in the corner. But we do have a waiver at NIH that allows us to make some awards above these guidelines. And so it's important, again, to reach out to Natalie, or Todd, or other program staff to talk about your budget, because there may be some flexibility there, particularly if you're doing human subjects, large animal work, or animal studies that may require additional time or money.

Reach out and talk with us. There's probably some flexibility that you might not be aware of, and we can help talk through that, as well. There's a wealth of information on our website, including new funding opportunities, Information about exactly how to apply, or the Applicant Assistance Program.

Again, I know a couple of companies here may not have received an SBR or STTR award yet. You can also look at the Applicant Assistance Program. But at the end of the day, the majority of our applications still do come in through this general omnibus solicitations. And we're really interested in those exciting new innovations.

We're interested in, again, helping translate some of those innovations and getting them into the hands of the people that need them. I also want to talk a little bit about the new office that we have here in the Office of the Director. The SEED office, the Small business Education and Entrepreneurial Development. Now seed is a word, but it's an acronym and a word. And it really helps show that we are part of America's seed fund, which is what the SBR and the STTR is. We are seeding those innovations, seeding those businesses.

So there is a recognition that there is this innovator community at NIH. And we really need to help provide not just funding through the SBR program, but additional support beyond that funding to make that transition into the marketplace possible. And we need to develop those relationships with strategic partners, investors, academics, and companies to make that happen. There are three parts of that SEED. One is, again, the Small Business Programs, which I manage and run.

But there's also academic innovation and innovator support. I'm going to spend a little bit of time talking about some of the innovator support programs and resources that are available to our awardees to, again, help them bridge that gap. For our awardees-- again, we recognize that a lot of the small businesses that we work with are fairly new. This may be their first company.

This may be the innovator's first company, or they may have only had some limited experience on the business side of things. And there's a recognition that that means that individuals may need a little bit of additional support to make sure that their innovations can go all the way to the marketplace. As part of the small business programs, we have something called TABA. That's Technical and Business Assistance. Centrally, we have a new TABA needs assessment program, that anyone who's received a Phase I can come in and apply for, provided you have not used our centralized services in the past.

If you have any questions about eligibility, you can always reach out to us at, and we'd be happy to answer any questions you have about the TABA needs assessment program. What's great about the program, and I can talk a little bit more about it, but it really helps companies assess what their commercial needs are, and help them determine what that next step may be for their business.

What are their gaps? What do they need to do next? Companies can also ask for TABA funding, so Technical and Business Assistance funding in their grant applications. So often, if you're coming in for a TABA needs assessment program in the Phase I, that could help you determine how best to utilize any request that you make, and help guide your Phase II application. Outside and separate from TABA, we have other services, as well. Education services, such as I-Corps or C3I, those programs really can help, again, with education and entrepreneurial education for those investors where this may be their first business, and they really want to better understand how to think about the market and how to think about their company moving forward.

In the funding and support, we have the CRP, which I mentioned, but we also have regulatory and business development consultants. And we support companies to go to company showcases throughout the year, and really take advantage of partnering and investing opportunities, again, to make those connections with investors and partners. So again, we have the innovator support team that provides that regulatory and business consultant and expertise.

There's a lot of expertise here on this slide. It's pretty amazing. Investors-in-residence, entrepreneurs-in-residence, intellectual property, regulatory and reimbursement, these are available for individuals who have awards, again, through our small business programs.

And I encourage you, if you have questions or if you need expertise and support, to reach out to your program officers. That's always the best place to start if you have an award, and we can see what is the best resource for you to take advantage of for your specific needs. So that leads me to the most important piece of advice. This is true if you're trying to apply.

This is true during the life of your award. This is true across the board, is to talk with us. Prior to submitting anything, whether it's that first grant, whether it's that Phase II, whether it's that Phase IIB, or CRP, or whatever you're planning to submit, always talk to a program officer. Very important. It's important to reach out ahead of time.

So I remember my time as a program officer. My calendar got extremely busy as we got closer to the application deadline. So very important to reach out early. But also, as you're going through your award, as well, I encourage you to reach out and talk with your program officer if you have questions. If you have a question about either a resource that I mentioned today or are coming and may have an issue, or may want to know what resources are available, oftentimes, the program officers are the best person that can help connect you with not only what might be available from an NIH perspective, but also what might be available from their specific institute, because again, each institute and center may offer additional resources on top of the more general ones I talked about today.

Natalie and Todd will go into some of the details for their respective institutes. So I think, yes, this is the get connected slide. So obviously, if you have any questions about anything I talked about today, again, there is that

We'd love to hear from you. You can also go to the website. We have a Twitter account. We also have a listserv where we do push out information about different opportunities and resources that are available.

So I do encourage you to reach out and talk with us. So with that, I think we can go to the next slide. And I will turn it over to Todd. So take it away Todd.

Thank you very much, Stephanie. Thank you everyone for joining. We're excited to launch the LINCS event. And we look forward to engaging with each of you as we go through the next two days. Just a reminder, many of you should be viewing this from the Jujama account.

We have lots of great companies there, and lots of great investors. So do go in and request meetings. And that's what it's all about. And the partnering will be open for a couple of weeks.

And of course, you could always take meetings offline. So for today's talk, I want to focus on the SEED fund at the NIA, and mainly through the SBR and STTR programs. So the NIA fits into the overall NIH picture that Stephanie just talked about. At the NIA, for FY21, and we expect the budget to be about $132 million. And this represents significant growth from where we were six years ago at NIA at only $34 million. So we're fortunate to be able to have congressional funding around Alzheimer's disease and other areas to be able to really push innovation in these fields.

And we hope to do so with some great innovations. Next slide. So I specifically lead the NIA Office of Small Business Research as well as NIA's training programs.

And our office has several core activities. We centrally coordinate the SEED funding programs across the NIA. We provide guidance to potential applicants. And we encourage applicants to come talk to us before they apply so we can demystify that application process. We conduct outreach virtually now, but also physically, once we're able to safely. Funding, we seed specific topic areas, and make sure that if we see any gaps in innovation, we can help fill them.

Overall, our real goal is to help companies reach key value inflection points, knowing that we'll often fund things at an earlier stage than private investors would. But our hope is to be able to help support the collection of data that will allow a company, when that data is successful and positive, to reach key value inflection points. And then when they do reach those key value inflection points, we realize that those companies are going to need external funding. And we tried to help in that networking fund. And this conference could not be a better example.

We also really work with existing stakeholders. For example, we work with ADDF who is participating in this meeting, where they may be able to provide bridge funding to some of our Phase Is and their interest space to help get them to a Phase II. And we've worked with the Longevity Innovation Summit to connect some of our companies and things like that. And then one thing we really focused on recently, we call this the year of entrepreneurship at NIA, is we have several entrepreneurial development programs that will be rolled out throughout the year, including a couple that I'll talk about today. So the NIA has four scientific research divisions.

And if you're interested in learning about some of the great scientific initiatives that are going on at NIA, I really encourage you to attend the talk tomorrow morning where we'll talk about some of the both NIA and NINDS major scientific initiatives where some really exciting results have come out, such as AMP AD or Geroscience initiatives, of bringing a blueprint, as well as our intramural program. So that talk should be really exciting, that panel. And I encourage you to participate. But the NIA's four scientific divisions are the Division of Aging Biology, the Division of Behavioral and Social Research, Division and Geriatrics and Gerontology, and the Division of Neuroscience. And we coordinate the SEED funding across all these divisions. So we're interested in a wide range of innovations of the NIA.

Obviously, anything that can help the health of older adults, and that includes Alzheimer's disease and related dementias, aging in place, community aging, age-related diseases and conditions, research tools, and you see additional areas of interest to highlight some specific things. On the right side of the slide is a snapshot of our portfolio at any point in time. And it shows that about a third of our portfolio tends to be therapeutics, whether that's primarily for Alzheimer's disease, but also addressing other aging-related conditions. And then you'll see that we have a lot in the sensoring monitoring technologies, digital mobile health, supportive devices. That makes up a major part of our portfolio.

And then imaging devices, in-vitro diagnostics, and research tools. So I don't think I have to tell this community about the challenges that we face related to Alzheimer's disease. We're fortunate that we have funding available to help dilute some of the risk that exists in the space. And we look forward to seeing some more great early-stage opportunities that we can help support. So Stephanie mentioned the overall funding at the NIH.

And we participate in the omnibus, as well as we have a specific opportunity with NINDS on advancing research on AD/ADRD, which is, essentially, kind of like an omnibus for AD/ADRD, meaning it can be investigator-initiated. Whatever application you may have to address either general for the omnibus or Alzheimer's disease and related dementias for the AD/ADRD-focused FOA, we'd be very interested in seeing. And then we have a number of other funding opportunities that can be found on our website. So I want to mention some of the technical and business assistance that Stephanie introduced.

Awardees can ask for funding in the application, especially for the Phase II. We really encourage them to do so, because we know that our companies need help with IP or regulatory. They'll have to hire the consultants and things like that. So they can ask for that as part of their application. Next slide.

But I will say for the TABA in Phase I, we actually just launched a great program for a needs assessment program to help companies identify their needs. So for the Phase I, we really encourage companies to participate in that program. If you're already at a Phase II and need more technical and business assistance, one great opportunity is the Commercialization Readiness Pilot Program. If you just need to further research, the Phase IIB is a great opportunity. And the link is provided here for the CRP. One major focus of ours is really diversifying the portfolio.

And we feel that that is absolutely critical to getting the end results that we want to get, in terms of the level of innovation. So we have several programs, one of which is the Diversity Supplement Program. So for those of you that already have an SBIR award at the NIH, we really encourage you to think about adding to your team and being able to conduct additional research by adding someone diverse to your team, applying for diversity supplement, where we will provide the funding to pay for that person and to pay for the additional research that they will do. So it's really a win-win, in terms of you are able to diversify your project team and expand what you are funded for all at the same time. And it's a rolling application.

And we review them on a monthly basis. So it can be a great way to expand what you're doing. So we hope to fund a lot more these, so please look into this. Get in touch with your program officer, as well as our office, and we'd be happy to consider providing additional funds to this mechanism. And for those that have not had luck getting funded from the NIH before, we strongly encourage you to think about the NIH Applicant Assistance Program. And we do encourage participation from underrepresented individuals in that program.

It's essentially a 10-week coaching program to help companies understand how to fill out that application. And it's held ahead of every application received date. One great resource has been the sample applications.

Traditionally, it's been through the NIAID We actually are in the process of launching a few new sample applications from the NIA. And the first ones we're going to focus meet a gap that don't exist with the NIAID applications, in terms of technology and digital health-type applications. And we just launched our first web-based sample application. Well, you could even see the summary statement, as far as what the reviewer concerns were. And we have a couple more that we hope to add to our website in the next couple of months.

So I think if you're looking to apply and want to see how you write a successful application, this is a tremendous resource for you to go to. I mentioned some of the entrepreneurial programs that are coming up, the National Advisory Council for the National Institute on Aging has approved the concept for Research and Entrepreneurial Development Immersion Programs and potential funding opportunities that can help incorporate entrepreneurial training into the career development and small business programs at the NIA. We understand that in addition to supporting the development of research skills in our next generation of scientists, we also need to support entrepreneurial science policy, science communication-type skills that will enable them to be competitive for the broad types of careers that our trainees will often end up in. So more coming soon. And we just launched the Entrepreneurial Workshop Series.

We had the first session a couple of weeks ago. And this is designed for our portfolio companies that have interest in any area around entrepreneurship. So each session, about once a month, will have a specific topic. The first one was around opportunity assessment, figuring out which is your market, how to address that market.

The next one will be about corporate governance, including things about board formation, both a scientific advisory board, the board of directors, and really explain all of that to you. And we have entrepreneurs-in-residence and investors that will help walk you through each of these areas in each session. So definitely look for your email to join those great sessions. And mentoring entrepreneurs-in-residence at NIA, we have Don Rose who can provide valuable guidance and coaching to NIA-fund companies. So if you are currently in our portfolio and you have questions about anything relating to business development, you can actually contact our office and schedule a 45-minute meeting with Don, and just ask any business development questions.

Don also spends part of his time as a special advisor at Hatteras Ventures, so he is very familiar with-- he's been the CEO of startups. He's been an investor. And he can really help answer questions across the spectrum.

And we plan on adding an additional EIR in the age and tech space in the coming weeks. So if you have not applied before or have not been funded before and would like to, as I mentioned, we'd like you to get in touch with us. This is a great first-page draft of the Specific Aims page, which is a key score driving page of the NIH SBIR application.

If you send that to us, we'd be happy to provide feedback. And connect with us if you have any questions. We anticipate getting the question about will the slides be available. If you email us at this link, we can send you the slide decks.

Also, we will, eventually, have the presentation posted to our website once we are able to get it captioned and things like that. So look for that in the coming weeks. Thank you. Natalie, all yours. Thank you so much, Todd. So hi, everybody.

My name is Natalie Trzcinski. And I am a scientific project manager at the National Institute of neurological Disorders and Stroke. And in particular, I hold all the small business grants related to stroke and neurodegeneration.

So at the National Institute of Neurological Disorders and Stroke, our small business set-aside is approximately $70 million a year. And at any time, we have between 150 and 200 active awards in our portfolio. At the end of the presentation, I'll include a link to all of our active awards.

So as Dr. Koroshetz will explain more tomorrow, NINDS is obviously not the only institute at NIH that funds neuroscience-related research. Obviously, our colleagues at the NIA do, as well, and follow closely behind. We are the institute that covers all stroke-related research, as well as other key diseases like epilepsy, spinal cord injury, traumatic brain injury, as well as hundreds and hundreds of rare and genetic neurodevelopmental and neurodegenerative disorders. I want to specifically note for this conference, in terms of where NIA and NINDS stand in terms of Alzheimer's-related research, this is a shared area of interest between our two institutes. NIA is the lead on Alzheimer's disease-related research, particularly when it comes to AD clinical trials and clinical research, whereas NINDS is the lead for vascular contributions to cognitive impairment and dementia, or VCID, Lewy body dementia, and frontotemporal dementia.

And as you'll see from the NINDS-supported companies that were selected to showcase today, we are the lead for the neurodegenerative diseases of ALS, Parkinson's disease, and Huntington's disease. As Stephanie alluded to, there's overarching common principles across the SBIR program, across all of NIH. But each institute is a little bit different. We're kind of like states within the United States. And so it's important to know how different institutes stand in priorities, in terms of funding decisions, in terms of allowable budgets, and whatnot. And I just want to make the point that NINDS is a very investigator-initiated institute.

Our first priority is funding proposals, with the greatest potential to advance our mission and reduce the burden of neurological disorders for everyone. We do have a priorities notice out that is included on this slide. And that will note that we, in particular, like I said, need to advance our mission. That's the first and foremost, most important thing to us. But we're also looking for companies who are dedicated to our mission space, in particular those who have chosen treating, or diagnosing, or being related to a neurological disorder as their first indication to market.

We're also looking for companies with really novel technologies, as well as companies that have never been funded by the SBIR program before. We really feel that diversity of ideas makes us all stronger. I also just want to highlight, too, here, our email address. Feel free to contact us if you're not sure if what you're looking at is in our mission space or not, if the disease that you're looking at is in our mission space or not. Feel free to send us an email.

Send us your aims page, and we can let you know if it's in the NINDS mission space or not. Just to give a sense of our structure at NINDS, we are divided into three different divisions, including the Division of Neuroscience, the Division of Translational Research, and the Division of Clinical Research. And throughout the divisions of clinical and translational research, we have many specific and dedicated programs to cover certain topic areas, as well as certain components along the translational and clinical spectrum. And so that's the purpose of this slide here, to show how many of these different programs exist that kind of hit all along the spectrum, and hit certain portions of them.

I also just want to note, though, that we support studies from proof of concept all the way up to Phase IIB, through regular SBIR opportunities, including the omnibus solicitation. So that being said, many of our specific translational, late-stage translational, and clinical programs have specific opportunities that are only open to small business. And those are highlighted in yellow here. The Small Business Program likes to call ourselves the octopus of our institute, in that we have our tentacles in a lot of different programs throughout the institute. And so, again, this is one of those instances where if you see a specific type of program that seems to fit in particular what you're doing, feel free to contact us and find out is there a small business-specific opportunity that you can apply to.

So a lot of these programs that I've mentioned, these late-stage, translational, and clinical programs are milestone-driven. They're meant to mitigate risk as you move throughout them. And attrition is expected with these programs.

If you don't meet your milestones in any one year, funding can be cut off. So these aren't your standard NIH RO1 grants where you pretty much have five years of stable funding. That said, these come with higher potential budgets, as well as, in a lot of cases, a lot of programmatic and outside support with these projects. A lot of them are cooperative mechanisms, so that means you work very closely with NIH staff on your project. And like I said, in some cases, you get access to outside consultants. In some cases, you also get access to outside CROs who can also do big chunks of the work for you.

You don't have to go out and find your own CROs in these cases. As I mentioned, a lot of these cooperative agreements programs have parallel funding opportunities that are ones that are open to academics, all comers, and ones that are only open to small businesses. And you're going to want to look for those that have the U44 mechanism in the title of the funding opportunity. So in these cases, your application will get the same scientific merit review as those that are in the academic track.

And you'll get all the same resources as those that are chosen for funding in that other track. But importantly, you're only competing against other small businesses for that funding opportunity. You're utilizing the small business set aside in those cases. So this is just a list of all these cooperative mechanisms, and specifically the funding opportunity numbers with them.

But more importantly is the contact information for the program directors who run these programs. And I really, really want to highlight, in these cases, how important it is to read the funding opportunity, come up with an aims page that you feel like fits the funding opportunity, and talk to one of these program directors. It's really key for these.

These are very competitive, very highly stringent programs. And so it's really important to talk to a program director before you apply. I just want to highlight the Devices U44 program which Nick Langhals will be speaking about tomorrow at NINDS, and then also the Small Molecules Therapeutics Program, that is actually run through the NIH blueprint, that Chuck Cywin will be speaking about tomorrow.

In terms of the Phase IIB and CRP funding that NINDS participates in for our supported companies, I do want to point out that we do our phase IIB a little bit differently, in that we have our own funding opportunity for phase IIBs for NINDS, related Phase IIBs that are listed here. And in particular, if you're doing a clinical trial in a Phase IIB, you will need either IND, IDE, or indication of non-significant risk at the time of application for that funding opportunity. We also strongly encourage matching funding for our Phase IIB. The CRP, we participate in two of the three large CRP announcements. And again, in terms of the clinical trial, if you're doing a clinical trial in a commercialization readiness pilot program, we strongly, strongly encourage you to have had procured your IND or your IDE at time of submission.

And we will prioritize funding clinical trials that have this information. So as has been reiterated many times by Stephanie and Todd already, these are really instances where we really encourage you to talk to your program officer, talk to myself, or other program officers at NINDS about these programs if you're interested in submitting a Phase IIB or CRP. If you've received a Phase II from NIH and are interested in one of these opportunities, talk to us.

We really encourage you to do so. I also just want to point out that NINDS also participates in I-Corps as well as the C3i programs that have been mentioned. We also participate in the Needs Assessment Program.

We really encourage those Phase I companies to take advantage of that. We are also a participating institute in the Diversity Supplement Program. I'm actually the lead for that. So I really encourage you to reach out to me if you're interested in supporting a trainee. I'd be happy to talk to you about what makes a competitive diversity supplement application.

And again, we encourage our companies to take advantage of the SEED innovator support, showcase opportunities like this, as well as TABA support. And finally, I just want to point out that we're always looking for ways to facilitate partnerships for our companies, and encourage any of those that are interested to reach out to us if you're looking for ways to synergize between what you're looking for and what our companies might be able to provide for you. We want all our portfolio companies to succeed and move forward to commercialization. And I just want to encourage the use of RePORTer for those investors, partner companies that are there today, if you're interested in finding out what NIH supports, in particular. I don't see the link showing up right now, but we'll have that corrected. There's actually a link here to our active portfolio companies that I'm happy to share with anyone.

So it will just bring up a list of all our active grantees at any moment in time that you click on it. And I'm really happy to walk anyone through RePORTer. For example, if you want to look at, hey, these U44 programs sound really great, really intense. I want to find the companies that went through that, and I want to partner with them.

We can show you how to do that. So feel free to reach out to us if you'd like to learn more. And with that, I will end and hand it back over to Stephanie. Thank you, Natalie. And we do have some time for questions.

Now I'm not seeing a lot of open questions in the chat, but I encourage you to do that. We are looking at those. And this is a great opportunity to ask us some of your questions. While we're waiting for those questions, I know I have a question, which is, how does NINDS and NIA really think about success in the small business programs, particularly since many of the companies that we support are in those earlier stage? Again, you're often de-risking those technologies. So how do you guys think about that and think about that investor handoff? Natalie, go ahead. No, you can go first.

Sounds good. Really, there's no one shape or size of what success is. It's going to vastly change, depending on the type of technology and understanding that therapeutics is going to have a much longer runway commercialization than potentially a research tool, another type of example, digital health. but it may not be

the same regulatory thresholds. I mentioned earlier about our real goal being to help support the collection of data that can help companies get to key value inflection point. And I think when we see companies hit those value inflection points, then those can be defined successes.

We have examples of commercial successes like, as an example, Avid Radiopharmaceuticals. When Dan Skovronsky, now the CSO of Lilly, when he first spun out that company, the first source of capital that he applied for was, in fact, SBIR. And now the main types of PET imaging that's done in clinical trials for AD has been the Avid Radiopharmaceuticals technology, where real initial early development was done through SBIR.

So that's one example of something that got to commercialization. More recently in that same diagnostic space, really exciting is C2N Diagnostics just commercializing the first blood-based diagnostic for Alzheimer's disease. In the technology space, BioSensics, through a license to GreatCall and then acquisition to Best Buy Health has been commercializing some of the work that they did through SBIR funding around fall prevention and detection-type sensors.

But then, also, success can be more intermediary and actually moving forward. So one example shows that while the SBIR, we have the Phase I, the Phase II, the CRP, the Phase IIB, that can total about $8 million or $9 million in a six to seven-year period. And again, this is project-based. So we do have companies that might have multiple of those projects. But just one project moving through that pipeline can total a significant amount of money, but not nearly the amount of money that you may need to get to the clinics, through the clinic.

So one great example, Cognition Therapeutics, which used our funding to actually get to the clinic, used the Small Business Program funding, even do, I think, a Phase I clinical trial. And through the NIA's clinical efforts and initiatives, was just funded by the NIA for about $70 million to $75 million to a robust Phase II clinical trial for an Alzheimer's disease therapeutic, the type of trial we really need to be done in that robust fashion. So it's an example that the SBIR is really important to help our small companies, but it is not the only way that we fund small companies, either. And so each of these things is an element of success.

And we're just happy to see that our company is able to move forward from one step to another. Yes, definitely. Agree with all of that. I just want to add the interest in really supporting rigorously-done research.

And one of the key things that we think about also, in terms of success, is having a clear go/no-go answer at the end of each of these phases. If you find out that things aren't working, it's been tested in a rigorous manner, that's OK. That's additional information for the scientific community. So NINDS is really interested in supporting really rigorously-designed experiments.

It can be risky. We're about risk mitigation. It can be really novel, innovative. But if you have really rigorous sets of experiments to test it out, that's the kind of thing that we want to see.

I can just add a little bit of NINDS success stories really supporting those academic investigators who might not have the resources, the knowledge about the commercialization process. For example, Lift Labs was founded by someone coming right out their postdoc, pretty much working in their garage developing this spoon that mitigates hand tremor. You can find it on Amazon. The company was bought by Google. And you can order this on Amazon right now.

So those are instances of innovators that we like to support and build the resources around you to help move your product forward. You shouldn't fail because lack of knowledge about the commercialization process. That's what we're hoping to mitigate. And the good news is we got a couple of questions here.

There was a question, and this is on the success vein, talking about NIH, NINDS, or NIA have a connection to help small businesses obtain a government contract. And that's an interesting component of the Small Business Program. This is a phase program, so there's Phase I, Phase II. And many agencies use what they call the Phase III, where they're the actual purchasers of the technology. NIH is a little bit different in that we generally don't purchase the technology. Again, we're here to help it get to the marketplace or an inflection point with either an investor or a partner.

So we generally aren't looking to purchase the technology through a Phase II or through a sole-source contract, just because that's the nature of how we utilize our programs. So we're a little bit different from some of the other agencies that may be out there and use the Small Business Program for other things. We did get a question about clinical trials. And I know clinical trials in the Small Business Program for both NIA and NINDS are a little bit different. So briefly, can you guys touch on how you all utilize clinical trials. If somebody has a clinical trial, what should they do, other than contact you? Yeah so at NIA, I looked, took a snapshot.

Somewhere about 85% of our work is pre-clinical in nature, in terms of what's funded by SBIR and STTR. Somewhere between 10% to 15% is clinical. And you need to go and look at the specific funding opportunity, but at NIA, we generally don't have clinical trials-- well, there are NIH now clinical trials, specific FOAs. But they're not separate programs.

They're companion funding opportunities for the same program. But we separate them out into clinical FOAs so we can make sure that the application includes the necessary information for proper review. But generally, the different funding opportunities that we have, most of them do have a clinical trial companion FOA that incorporates clinical trials. Of course, for this SBIR and STTR program, it's limited to the size of the budget. So our Phase IIs are $2 and 1/2 million.

Our Phase IIBs and of CRPs are between $3 million and $3 and 1/2 million. So through the SBIR program specifically, we're not going to be able to fund large Phase IIs, as an example. But early clinical work is definitely possible. And I can just clarify, too, that NINDS does not participate in the large omnibus clinical trial required solicitations. We actually have our own separate funding opportunities for clinical trials. And a vast majority of them, as I alluded to in discussing the Phase IIB, actually require IND, or IDE, or indication of non-significant risk from your IRB at time of submission.

There are a few funding opportunities, mostly through the cooperative mechanism agreements, where it can span the pre-clinical to clinical stage. For example, in Chuck Cywin's Blueprint Therapeutics Network, they can take you all the way from Med Chem in small molecules to a Phase I clinical trial. The idea through that is you're working very closely with staff, you're working very closely with consultants throughout. And risk is being mitigated in a very stepwise manner throughout that cooperative mechanism, whereas if you wanted to receive a clinical trial through the regular standard R mechanism, that you would need IND or IDE at submission.

But again, talk to us. Talk to us, and I'd also state, I put the definition of an NIH clinical trial in the chat, because, keep in mind, the definition of an NIH clinical trial is not the definition of an FDA clinical trial. If you're doing human subjects research, you may be doing a clinical trial and not realize that that actually falls within our definition. So just make sure, again, reach out and talk with us. And really, if you take nothing from the conversation today, that's the big thing that we would really encourage you to do. Now very, very quickly, because we only have a couple of minutes left, I did get some questions around some specific topic areas, in particular for NINDS, if NINDS funds pain diagnostics, therapeutic products, things for migraines.

And then whether or not either NINDS or NIA are interested in supporting COVID-19 research, and where that stands with both of your institutes. Yeah, I can answer the migraine question. Yes, migraine is within the NINDS mission space. And we do fund diagnostics, therapeutics related to migraine research. Again, one of those cases where draw up a specific aims page. If you'd like to send it our way and talk about it, happy to do so.

But yes, migraine is within our mission. And in terms of COVID-related research, yes, we are interested. It depends on the nature of the research, and which is the right institute, and what aspects of COVID you're addressing. But if it's COVID-related that is specifically related to aging, older adults, Alzheimer's disease, then, yes, we will definitely consider those types of projects.

Yep, and NINDS is interested in examining neurological consequences of COVID, specifically in instances of where it's really clear that there is a big opportunity, time-sensitive opportunity, not one of those cases where it's a long-scale, maybe pre-clinical process. We would support that through the omnibus solicitations. But we do have a specific supplement for time-sensitive neurological consequences of COVID, if you have an existing NINDS grant. So with that, I know we are out of time. There was one last question asking about the available intellectual property to license. And that's actually done through the tech transfer offices at each institute.

So hopefully both Natalie and Todd can look and put some of those links in the chat. That is specifically associated with our intramural program. And so we do have tech transfer offices that are willing to help guide you and talk with you about what's currently available. And, yeah, in the session tomorrow, if you have tech transfer questions, available, we'll have one of our intramural professionals. And then also tech transfer can help us answer. So definitely attend that.

I do want to encourage everyone, in terms of today, we have a break coming up, but the company showcase part starts. So there will be a presentation from several of our digital health companies. And then one of the nice things that we added to this event is what we call breakout sessions, where essentially, if we were in person, as you can imagine, going up to the podium after a session, and going and being able to ask some specific questions that you thought of when you heard the pitch. Well, you can now basically join a session with that company right after you hear the talk, starting at 1:30, where you can ask any questions that you have in your mind. So I definitely encourage you to attend those breakouts, as well. And then encourage you to attend the other sessions for the rest of the day.

We have the medical device showcase at 2:00, those breakouts, and then the panel on specific investors interested in funding aging technologies. Some real little new investment capital available in that space. And then we'll close out today at 4:30 with a keynote by Joe Coughlin, of MIT's AgeLab that I guarantee you will be exciting, as well. So I look forward to seeing you in the future sessions and in the partnering. Thank you for your time.

Thank you everyone.

2021-04-19 21:18

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