Leverage SBIR STTR Funding & Other Resources to Create a Diverse Workforce in Science & Technology

Leverage SBIR STTR Funding & Other Resources to Create a Diverse Workforce in Science & Technology

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You can save the chat. So if you were to open your chat box, you'll see at the end there are three little dots on the right, and you can save that chat. We'll also, if you registered for this presentation, we'll share with you some of the links, and then our website, for those who are watching online, have a lot of the links that we'll be discussing as well. With that, welcome. Today we're going to focus on how to leverage SBIR STTR funding and other resources to create a diverse workforce in science and technology.

We have some great leaders with you today, experts from NCATS which is really focused on translational science process and how to move new treatments and cures forward. We're also joined by the National Heart, Lung, and Blood Institute. Both are part of NIH. Both have dedicated and strong small business programs, and we're really delighted to also have partner XLerator Network, and you'll hear from some of the leaders very soon. Some of my esteemed colleagues are Dr. Stephanie Davis. She is the small business program coordinator from NHLBI.

You'll hear from Dr. Eugene Krentsel. He's the chief scientific officer and vice president of strategic partnerships and alliance at XLerateHealth. Almesha Campbell, Dr. Campbell is the assistant vice president for research and economic development at Jackson State University.

And Dr. Meena Rajagopal, she is a program officer at the Office of Strategic Alliances at NCATS. And I'll be your moderator for the first portion, and we'll also have a dedicated Q&A.

Today we'll go through some really important foundational elements to help you understand what are the SBIR and STTR programs? What are the opportunities and resources for small business both at NCATS and in NHLBI? And then we'll talk a bit more about the XLerator Network and EnRICH and then move into our Q&A period. If you have questions, again, feel free to use the Q&A chat feature. And with that, I'd like to welcome Dr. Meena Rajagopal who's going to share information about NCATS. Hi, everyone.

Thanks, Monique. Thanks for joining us today on this webinar. Before I start off, I want to say a big thank you to Stephanie, Eugene, and Almesha for working, collaborating with NCATS on this webinar. And Stephanie is a part of the NIH family, so it's always great to have her. And Eugene, I know Eugene from the NIGMS-led IDeA Hubs meetings wherein I've listened to his presentations and talks about where he updates the NIH regularly on what the XLerator Network does for small businesses.

So it's good to have you, Eugene. And I'm really looking forward to Almesha's talk and learn about resources that are available to specifically increase diversity in small business workforce. I appreciate all your time, and it's been an absolute pleasure and great knowing you all and working with you on this webinar collaboration. I think I'm now ready to dive into my talk. Let's go to the next slide, please. So NCATS, which is short for the National Center for Advancing Translational Sciences, is one of the 27 institutes at the NIH.

We are a relatively new institute at the NIH. We just celebrated our 10th year anniversary this past December, and we are a little different when compared to the other institutes at the NIH. And what I mean by that is NCATS is not focused towards one particular disease. We are disease agnostics, and our NCATS mission is to foster and promote translational science so that, ultimately, that would lead to the development of more treatment options made available to all patients more rapidly. And the NCATS small business program is very much supportive and aligned with our mission statement that we fund platform technologies that typically either identifies or mitigates a bottleneck in the translational science pipeline, so again, leading to the development of providing more rapid and accurate diagnostics, more treatment options, and better management of various diseases and conditions. Let's go to the next slide, please.

So towards this mission, the NCATS has a number of initiatives that it manages and funds. A few of those are listed on this slide here. The first one is the Clinical and Translational Science Awards Program wherein more than 50 institutes across the nation participate and are funded. And again, they all work together to speed up the translation of findings from basic science to improve patient care.

Then we have the-- I did say, I'm sorry. I did say that we are disease agnostics. But then having said that, we do have a high interest in rare diseases, and that's exactly why we have this Rare Disease Research Network Program to promote research in this specific area.

We also have something called the New Therapeutic Uses Program wherein NCATS tries to pair up investigators with shelved assets from the pharma that is probably failed for a particular indication, right? But the purpose of this program is to see if that wealth of clinical information available on that shelved asset can be repurposed for a different disease. The application for the New Therapeutic Uses Program is accepted yearly and on a rolling basis. NCATS also houses the Chemical Genomics Center which does a lot of high throughput screening for drugs. And two other programs that we run out of our intramural program are the BrIDGs and the TRNDs program that I would like to touch upon a little bit more in detail towards the end of my talk. But NCATS also has these other cool re-engineering initiatives like the Tissue Chip program that we run out of our center.

Let's go to the next slide, please. So now going over a quick overview of the SBIR STTR program in itself, SBIR is short for Small Business Innovation Research. And STTR, which is Small Business Technology Transfer Research programs are America's seed fund, and it is one of the largest early stage funding available for small businesses research and development. This is a Congressionally-mandated program in which a number of other institutes participate like the CDC and the FDA, including NIH, and the budget for the small business program tracks the agency's budget. And what this means at the NIH is that it's about a billion dollars that is shared among the T4 participating institutes within the NIH, excuse me. And I do want to share a little bit of a tidbit information that a lion's share of this budget goes towards funding the SBIR program.

This is not to say that the NIH prefers the SBIR or STTR. Definitely not, but this is just how Congress had made-- mandated or decided where the majority of the funds should go. So the slide here does have the FY21 funds, but then we are still waiting on the reauthorization for the next fiscal year which we hope gets through, it gets passed, but that's the hope. It's about a billion dollars. A little over a billion dollars is set aside for the small business program. Let's go to the next slide, please.

So there are multiple advantages to applying to the NIH small business program. One, like I said earlier, the budget tracks the agency's budget. So what this means is the funding is stable and predictable. And second of all, it is non-dilutive meaning the IP rights belong to the small business. NIH is never the customer.

And once awarded, there are other resources within the NIH that the small business can leverage to further develop and commercialize their product or technology. There is one other added advantage to applying to the NIH program, and that's the peer review process. Every application that comes in through this SBIR STTR mechanism goes through a rigorous peer review process that is conducted by the Center for Scientific Review, another Institute within the NIH. And what this allows, the small businesses has an opportunity to go outside of NIH and look for other potential collaboration or funding opportunities. Because guess what? Now your science or project has been validated by the National Institutes of Health.

So that's one of the biggest advantage of applying to the NIH small business program. Let's go to the next slide, please. So with this slide, I just want to highlight a few key differences between the two programs. So within the SBIR, the small business is allowed to partner up with a nonprofit research institute.

However, this is an absolute requirement under the STTR. So in other words, if you wish to apply under the STTR, then the small business has to partner up or work with a nonprofit research institute like a US college or a university or other federally funded research and development centers, what we call FFRDCs. The other major difference between the two programs comes with the primary employment of the principal investigator.

So the primary employment of the principal investigator under the SBIR program has to be with the small business, obviously. But there is some flexibility when it comes to the STTR program. So under the STTR program, the primary employment of the principal investigator can be either with the small business or the nonprofit research institute. But I do want to drive home a very important message from this slide, and that's the line at the very bottom.

So no matter which mechanism that you apply to, SBIR or STTR, the award or the money always goes to the small business. Let's go to the next slide. So to quickly go over the three phase NIH SBIR STTR program here, and please be advised that these three phases is not the same as the clinical phases of a clinical trial. This is completely different. And, for instance, in-- under a Phase I, we are actually looking for applications that talk about a proof of concept or a feasibility study.

So we do encourage a few lines about the commercialization plan under Phase I, but it's not a requirement. And the budget that you can request under a Phase I is about 276K. Again, this is the SBA's set hard cap. However, each participating institute like the NHLBI and NCATS have their own topics of interest which we call waiver topics.

And if you wish to apply under one of those waiver topics, you can request over the SBA set budget hard cap of 276K. So at NCATS, you can request up to about 325K if you wish to apply under the waiver topic. Then there is the Phase II which is a more full blown research and development plan wherein the commercialization aspect or the plan is actually built into the application. Again, within the Phase II, there are two mechanisms. One, the fast track, and the second is the direct to Phase II. In the fast track, you basically combine the Phase I and the Phase II.

So you apply-- contingent upon meeting the Phase I milestones, your Phase II award would be made. And in a direct to Phase II, like the name suggests, you skip Phase I and directly apply for Phase II funding. And this is where you're very confident about your preliminary data that you want to apply to the next level. And the budget that you can request under a Phase II is about $1.8 million over a period of two years. But again, if you wish to apply under one of those waiver topics, you can request up to about $2 million. Then there's the Phase IIB, and please note that not all participating institutes within the NIH participate in the Phase IIB, bu NCATS does.

And I'm going to let Stephanie talk about the Phase IIB in which NCATS is participating, and this is led by the NHLBI. So I will leave it for Stephanie to talk about it, but just to quickly mention, at NCATS, we are looking to support projects under this Phase IIB so that we can help the small business get through the key inflection point. Like say you need to file an IND or you need state of the art, complex instrumentation. So that's when you can request up to about $1 million for about three years. Then there's the Phase III which is the actual commercialization part of this program.

So if you were to apply to a different agency, like say the DOD, then the Phase III is when the agency would actually buy the product or technology from you. But at NCATS, we want you to think of an exit strategy to, say, graduate out of the program. So those are the three phases of the NIH SBIR STTR program. Let's go to the next slide. There are different funding mechanisms available when you apply to the small business program at NIH. And what I mean by that is there's the investigator-initiated omnibus solicitation.

I do-- I'm very happy to let you know at this point of time that we do have the FY22 omnibus solicitation out on the streets. It's active. I would strongly encourage you to please go give it a read, familiarize yourself with the omnibus-- new omnibus solicitation funding announcement. And if you have any questions, please reach out to us. But then, going back to the different funding mechanisms, so there's the omnibus solicitation, and then there is targeted grant solicitation which is typically to promote a particular research area or-- excuse me, technology.

The funding, the deadline for the omnibus solicitation is typically twice a yeah, and these are standard deadlines in September-- January 5, April 5, and September 5. But this year I believe September 5 is a holiday, so the deadline-- the upcoming deadline for the omnibus solicitation would be September 6. The deadlines for the targeted solicitation usually track the standard deadlines of the omnibus solicitation, but depending on the topic of interest, it could vary. So again, I would strongly suggest that you familiarize yourself with the funding announcements, and again, if you have any questions, reach out to us. Then we have the contract solicitations, and since these are contractual agreements, there are some deliverables that have to be met. And the contract solicitations, the applications are due sometime in October, November time frame.

Let's go to the next slide, please. So like I said earlier, NCATS mission is to catalyze translational sciences so more treatment options are available to all patients more rapidly. And the small business program supports or funds platform technologies that support our NCATS mission and research priorities. And these would broadly fall under these three buckets. The topics of interest could be under either preclinical drug discovery and development; biomedical, clinical, and health research informatics; or clinical dissemination and implementation research.

I'm not going to get into the details of what subtopics are included in each one of those, but I think [? Melissa ?] is charting it out. So if you can check out the PDF and read about those topics and happy to have a conversation and see if your proposal is aligned with our research interests. Let's go to the next slide, please.

So with this slide, I just wanted to spotlight a few of the targeted funding announcements that are active and we are accepting applications for. Like I said, I'm going to have Stephanie Davis talk about the NHLBI-led SBIR Phase IIB which is small market awards to accelerate the commercialization of technologies for heart, lung, blood, and sleep disorders. But then I do want to draw your attention to the new funding announcement that we have which is the notice of special interest that is led by NIEHS specifically to promote innovative technologies for research on climate change and human health. And both NHLBI and NCATS are participating in these NOSIs. So again, please I would strongly encourage you to read the funding announcement, and if you have any questions, reach out to us. Next slide, please.

With this one, I just wanted to give you all a sense of the timeline involved in this whole process. So if you're looking for fast money, this is probably not the best route, and I'll tell you in a second why. Let's pick the September deadline. I mean, the deadlines mentioned in the slides are the standard deadlines, but again, this year September 5 is a holiday. So it would be the September 6.

So let's pick the September deadline. So applications are due by September 6 this year, and the scientific review that is conducted by the Center for Scientific Review happens sometime in October, November time frame. And then each institute has an internal review, and at NCATS, this happens some time around January or late February. And by the time the notice of award is sent to the applicant from the Grants Management Office, it's about-- it can be anywhere in between April or-- March or April. So it takes about six to eight months from the time of application to the time of getting to know whether your project has been funded or not.

And this is a waiting game which can be pretty nerve wracking, and we totally get that. But please understand that there are a number of offices, divisions, and institutes that are working along in this process, so it does take quite a bit of time. But when you apply for this program, do keep in mind the benefits that I went through earlier which is the non-dilutive part of it. So it's worth applying to the small business program.

So just keep that in mind that it does take eight to six-- anywhere from six to eight months for you to know the decision on your application. Let's go to the next slide. There are also some specially-- special designations set forth by the US Small Business Administration. At the time when you register your company at SAM.gov, you have the option to self-identify, and the eligibility criteria for these special designations of small businesses, again, is set forth by the US Small Business Administration. NIH has nothing to do with it.

But the reason why I want to bring it up to your attention is because both SBA and NIH track the number of applications coming from these specially designated small businesses. And this would in turn help us see if you have to do outreach events specifically targeting these small businesses. So I would strongly encourage if you can to self-identify your businesses when you register at SAM.gov. And if you did not, that's OK. I believe there is a way that you can get in touch with the help desk and get that going. Let's go to the next slide, please.

So now I want to jump into some of the resources that are available within NIH and also within NCATS for small businesses. And the first one that I want to talk about is the Applicant Assistance Program. So if you are applying to the SBIR STTR program for the first time or say you have not been successful in your previous attempts, then you are eligible to apply and leverage this free application preparation assistance program. They do help you with putting in a strong application for your Phase I for the omnibus solicitation, and the application portal is open about two months prior to the deadlines for the omnibus solicitation.

So you-- once you are-- you apply and you're selected, and I do want to mention here that not all-- again, not all institutes within the NIH participate in the Applicant Assistance Program, but both NCATS and NHLBI participate, and we do have a limited number of slots that has to be filled out-- filled in for each cohort for the three cohorts across the year. But then once selected, you will be-- you will work with a coach from Eva Garland Consulting Services who would provide you assistance in preparation and submission of your grant application. You would also have the opportunity to talk to program officials one on one and get their feedback on how good your proposal is a fit for their institute. And the main goal of the Applicant Assistance Program is to encourage small businesses' participation in the SBIR STTR program, particularly those that are owned by individuals who are traditionally underrepresented in the biomedical sciences research area. So NIH strongly encourages applications from these women owned businesses, socially and economically disadvantaged businesses, and businesses that might be located in these underrepresented IDeA states. So that's-- Applicant Assistance Program is an NIH-wide resource that, again, the small businesses can leverage to put in a strong application.

Let's go to the next slide, please. Another resource that we have available for our awardees is the Administrative Supplements to Promote Diversity. So again, I do want to stress that this is only for our awardees. Basically, if you have a member in your team that would qualify for this award, then the institute would pay for their salary. And the purpose of this funding announcement is to, again, enhance the diversity of the NIH supported workforce. Both in NCATS and NHLBI participate in this funding announcement, but again, I do want to say that this is open only to our current awardees.

Let's go to the next slide, please. Then we have the NCI-led I-Corps program, and again, our awardees can apply for this program, and NCATS will basically pay for the company to go through this training which is about eight to nine-week long hands on mentor program with a lot of opportunity for the company to network and really do some customer discovery and understand the market's needs. And the goal, again, for the I-Corps program is to equip these small businesses so that they can successfully take their product or technology to the market. Let's go to the next slide, please.

So a very similar program that runs out of our SEED office here at the NIH is the TABA, Technical and Business Assistance Program. And here we try to connect our awardees with a third party that would provide an unbiased assessment of your technical and business plans. And again, they would help you make some wise decisions, minimizing risk, and the goal is to make sure that the small businesses are successful when they take their product or technology to the market. Next slide, please. So we have the TABA Needs Assessment that is out there.

It's a funding announcement, again, for our current awardees who have not leveraged the type of funding that I talked about in my earlier slide. It is very similar. The goal is, again, very similar, but the funding announcement is out on the streets, and please go check it out. And if you have any questions, reach out to the SEED office or any one of us. We will be more than happy to answer questions.

Next slide, please. Now that I've talked about NIH-wide resources, I do want to touch upon some of the resources that we have at NCATS for small SBIR STTR eligible companies. Not just SBIR STTR eligible companies, I'm sorry, but also to other researchers including academics. So one such is expertise that our therapeutic development team has to offer and many of which is listed on this slide.

But again, the goal of this is to help researchers, both, again, academics and small business entrepreneurs, to get through the key inflection point and cross the Valley of Death so they can-- and help them achieve what they want to accomplish. This can be anywhere-- there is a huge, like I said and listed in the slide, that is a menu of services that you can leverage from, say, optimization of your medicinal chemistry, evaluation of your PKPD studies. We can also connect you with CROs to do your CGMP studies and provide you some regulatory assistance and support in addition to the one that is offered by the SEED office at the NIH. But again, if you are interested in any of these services, please reach out to our office, and we'll be more than happy to put you in touch with the right people within the therapeutic development team. Let's go to the next slide, please. So the other two programs that I want to touch upon a little bit more in detail are the BrIDGs and the TRND Programs.

So the BrIDGs is short for Bridging Interventional Development Gaps Program. Here the applicant actually comes in when you have already identified a clinical candidate. That we would look at your application, and specifically, the division of preclinical innovation team will look at the application and do the gap analysis, and we do help you out, say, to put a strong application for an IND filing. They work with the different modalities like small molecules, therapeutics, recombinant proteins. And again, the goal of the BrIDGs program is to help you cross that Valley of Death and be able to successfully file an IND.

Let's go to the next slide, please. Then there is the, very similar to BrIDGs program, we have the TRND Program which is short for Therapeutics for Rare and Neglected Diseases. The main difference between the TRND and the BrIDGs is that for the TRND Program you don't need to have a clinical candidate identified. You can come into the program at any of the preclinical stage, development stage. And I do want to iterate that both the BrIDGs and the TRND Program are available to all investigators, SBIR STTR eligible companies and academics.

Please reach out to us, and we'll be more than happy to connect you with the folks at the preclinical development team. Let's go to the next slide, please. So in this slide, I just wanted to share a case study wherein we had this academic investigator who came to us through the BrIDGs Program. She had identified a new molecular entity for treatment for a rare disease, and she had cobbled up about $3.5 million with her R01 and STTR combined. But when she went to have this conversation with FDA during one of those pre-IND meetings, she found out that she needs to do tox studies on two animal models which would easily cost about a half a million dollars.

And that's when she applied to the BrIDGs Program at NCATS, and our team looked at the application, and we determined that, yes, she needs these resources to be able to file a successful IND. And so we helped her out. Because of which she was able to put in an IND application that was very-- that was approved and ultimately was able to raise about $50 million in CDC funding.

So I just wanted to share that case study with you. Let's go to the next slide, please. I believe this is my last slide. So I just want to say that there are different ways that you can engage with NCATS, and I would prefer that you send us an email to that mailbox. And there are actually real people checking that mailbox, believe it or not.

My supervisor, who is the director for the program, and I check the mailbox every day and respond to those emails. So please do get in touch with us, and at the very least, we will be able to-- we would definitely connect you with our colleagues like Stephanie and others at other institutes when we think that your project is probably better aligned to their mission and better aligned to their research focus. But again, I really hope to hear from some of you in the near future. With that, I pass the baton to Stephanie Davis.

Thank you all. Thank you so much Meena, and good afternoon, everyone. My name is Stephanie Davis. I am the Small Business Program coordinator for the National Heart, Lung, and Blood Institute. So I'm just briefly going to be going over some of the specific resources that are available for NHLBI grantees and applicants.

Next slide, please. So the NHLBI Small Business Program, as our institute name would probably suggest, we are very interested in funding the development of innovative and commercially promising products to prevent, treat, research, and diagnose heart, lung, blood, and sleep related diseases. So there is one exception to this rule. If you are interested in developing anything for lung or blood cancers, it'll probably be more of interest to our colleagues at the National Cancer Institute. But any non-oncological diseases in these areas, we are interested in funding.

So our program is the fourth largest small business program at the NIH. We have approximately $120 million to fund just over 300 active projects. So if you look at this pie chart, this shows examples of some of the types of technologies that the NHLBI Small Business Program funds. Just over a third of our portfolio goes towards funding therapeutics which include, of course, biologics, small molecules, gene therapies, et cetera. About 30% of our portfolio goes towards supportive devices which include both surgical and therapeutic devices. About 8% each of our portfolio goes towards the development of research tools, in vitro diagnostic tools, and monitoring or diagnostic devices.

And then the remaining portion of our portfolio goes towards funding digital health and health IT type technologies and imaging devices. So in terms of the types of technologies we fund, we fund just about everything. And if you have a technology that is maybe in one of those smaller portions of the pie chart, please do not be concerned and think that we are not interested in funding it. This distribution does change on a yearly basis based on what applications we get through the omnibus funding opportunity announcements.

Next slide, please. So as I mentioned in the previous slide, our main mission space focuses on the development of new technologies towards the treatment, diagnosis, and research of heart, lung, blood, and sleep disorders. So while this does not include all of the conditions we are interested in at the NHLBI, this does contain a broad overview of the type of conditions we're interested in funding. So if you are developing a technology for a disease that you see listed here, there-- then you are probably going to want to apply to us. And if you are in doubt of whether or not your technology fits in our mission space, we definitely recommend reaching out to us.

And in addition to funding these heart, lung, blood, and sleep conditions, the NHLBI is also interested in funding technologies that can improve the implementation of and dissemination of evidence-based interventions for heart, lung, blood, and sleep diseases. So if you have a technology that falls in that mission space, I would definitely recommend reaching out to us as well. Next slide, please.

So here is a table that shows some of the different targeted funding opportunities that we participate in. So like and NCATS, we also participate in the omnibus funding opportunity announcements, and we will fund clinical trials through Phase I and Phase II for both SBIR and STTR applications. So while most of our applications that we get come in through those omnibus application funding opportunities and they are investigator initiated, here are some examples of targeted funding opportunity announcements that we are interested in. So as Meena mentioned, we do have two different Phase IIB programs which are designed to provide additional support for former Phase II grantees who need additional funds to meet their commercial and regulatory milestones.

So the Bridge Award Program provides funding for any heart, lung, blood, or sleep related technology. But she specifically focused on the small market award, and that is one that NCATS co-funds applications with us. The Small Market Program, I will provide a little bit more details later, but those are specifically for applications that are for rare diseases and pediatric indications. We also participate in the SBIR STTR Commercialization Readiness Pilot Program, and this is designed to provide additional funding to current and recent Phase II or Phase IIB awardees that need additional funds to cover activities that are not normally supported using small business funds. We also participate along with NCATS in the NIMHD Innovations for Healthy Living SBIR RFA. So if you are developing a technology or a device that is specifically focused on reducing health disparities, and in this case, the context is health disparities in heart, lung, blood, or sleep disorders, this is a really great funding opportunity to apply to.

We also participate in the technologies directed at enhanced pain management, the HEAL initiative RFAs, which are run by the National Institute for Neurological Disorders and Stroke. So if you're working on something that focuses on pain management in the context of heart, lung, blood, or sleep disorders, I would recommend checking these out. We also participate in the Innovative Diagnostic Technology for Improving Outcomes for Maternal Health NOSI just as NCATS does. And we also participate in I-Corps at NIH.

So current Phase I and early stage Phase II grantees through the NHLBI are allowed to apply through I-Corps to work on their customer discovery. And then recently we also signed on, just like NCATS did, to the Innovative Technologies for Research on Climate Change in Human Health. So if you're developing a technology that focuses on the intersection of climate change related health risks and heart, lung, blood, or sleep health, this is an opportunity that might be of interest to you.

Next slide, please. Another program that we participate in that is not a traditional funding opportunity announcement, but it is available to all SBIR and STTR grantees at the NHLBI is the Concept to Clinic Commercializing Innovation or C3i Program. So this is a program that is specifically run by our colleagues at the National Institute for Biomedical Imaging and Bioengineering .

And so what it's designed to do is to allow medical device-focused innovators to access the tools and framework that are needed to commercialize their technologies or their devices. So this program specifically will provide up to 24 weeks of entrepreneurial training to current small business grantees as well as some non-small business grantees. So if you have an R01 or a non-SBIR active award that focuses on the development of a medical device and you're interested, I recommend reaching out to see if you're eligible.

But the applications are due this August 5, and it's a really great program. And if you're a medical device innovator, I highly recommend checking it out. Next slide, please. So as I mentioned earlier, we have two different Phase IIB SBIR RFAs. So the first one-- well, that one is very broad and focuses on pretty much anything that is applicable under the NHLBI mission.

The Small Market Award is the one that we both participate in with NCATS. So in order to be eligible for a Phase IIB Small Market Award, you have to be a company that has previously received a Phase II award. It doesn't necessarily have to be through the NHLBI. It's just the project has to be within our mission space. The technology has to require regulatory approval, and it has to fall under one of these three criteria.

The first is that it must address a rare disease as defined in the Orphan Drug Act Amendment of 1984. The second criteria is that it must be a device that qualifies as a humanitarian use device, or it must be a technology that is targeted at a young pediatric population. So this program will provide grantees with up to $3 million of funding in total costs over a three year period. And so when we give out these awards, we do expect them to bring in matching funds. So for the small market awardees, since we understand that the awardees under this program are often dealing with technologies that have smaller markets or smaller patient populations, we are expecting a lower match compared to what we expect from our Bridge Phase IIB awardees. And what we expect is a one to three match.

So what that means is that if a small market awardee gets a $3 million award from the NHLBI and/or NCATS, we are expecting them to bring in an additional $1 million through other sources of funding. And that can include anything from non-dilutive funding to venture capital investment to angel investment, and we are pretty flexible in terms of the type of investment that we allow. If you're interested, please contact us for more details. And so through this program, since the NCATS is also very interested in rare diseases, they have funded several awards with us where we act as the administering IC, but they will contribute up to $500,000 every year if this is a project that they are interested in. So the Phase IIB programs accept applications only one time a year. So the next due date is going to be February 28, 2023.

So if you are a current Phase IIB-- if you're a current Phase II awardee and you're thinking that this program might be of interest to you and you'd like to apply for the next cycle, please feel free to contact me afterwards, and we can discuss. Next slide, please. So our Small Business Program is housed within the NHLBI Office of Translational Alliances and Coordination within the Division of Extramural Research Activities. So our office does provide a lot of really great resources to small business grantees including commercialization programs, awards to accelerate commercialization such as the Phase IIB and the CRP awards. We provide programs to support diversity, so we also participate in the Diversity Supplement Program and the Applicant Assistance Program. But we also provide resources to academic innovators, and these include programs such as the Catalyze Program which provides support for both academics and small businesses and the CAPCaT Program which provides funding to companies that are developing point of care devices for heart, lung, blood, or sleep disorders.

And then in our office, we also have several advisory staff members who are there to provide expertise to both communities. And the goal of having these services available is that we can cater to both the academic and the small business innovators to help further the development of heart, lung, blood, and sleep related technologies. Next slide, please.

And so here is an overview of some of the advisory experts that we have We have a really fantastic team of entrepreneurs in residence at the NHLBI. So if you are a current small business grantee or even if you are a translational researcher that's being funded through another mechanism, we have this team of experts who are available for one-on-one consults and also just to answer general questions. So if you're interested in setting up a consult with any of my wonderful colleagues that are listed here, please feel free to email me. But they are extremely knowledgeable in what they do, and they're here to answer any of your questions. Next slide, please. So that concludes my segment for the day.

If you would like to contact me, it looks like my direct line has been put in the chat. So please feel free to reach out with any questions, and I would like to pass the baton over to my friend and colleague Dr. Eugene Krentsel. Thank you, Steph.

Appreciate the introduction. Good afternoon, everybody. Those of you on the West Coast, you are still in the morning part of the day.

Next slide, please. I will talk about XLerator Health, XLerator network and our EDI resources that are available. And first I will talk a little bit about who we are and what we do. Next slide, please. XLerator Network is an NIGMS funded hub for technology transfer acceleration.

There were four hubs of this type funded by NIGMS covering different regions of the country. Ours covered the Southeast part which is Kentucky, West Virginia, South Carolina, Arkansas, Mississippi, Louisiana, and Puerto Rico. And there are three other hubs that cover other parts of the country.

Next slide, please. Their hub is led by a small business. We are ourselves funded through STTR mechanism, and we are a small business, XLerate Health, which is a health care focused accelerator founded in 2012 in Louisville, Kentucky.

Here is a photo of some of our core team members. We're using Steve Blank's Lean Startup Methodology to teach entrepreneurs how to build their businesses and scale. We're on both boot camp, 12 week boot camp, and intersession programs. We used to run those boot camp programs in person, one in Louisville, one in Michigan where we have a satellite operation. But in pandemic, we decided that everything will be gone virtual, so we're running two virtual programs. And we have a large number of mentors and coaches that provide-- and subject matter experts that are not only in our geographic space but also across the country and internationally who help mentor and coach startups.

Next, please. This is the list of their institutions, the consortium, constellation of 25 wonderful academic institutions across those six states and Puerto Rico led by XLerate Health and University of Kentucky which is our academic lead in this STTR funded program. Next slide, please.

So those are some of the things that we do. We run various entrepreneurial programs and training. We have a talent network including XOR. It's executives on a roster program where we help startups that are coming from academic institutions to find their executives, C-level and otherwise, very interesting program. I would love for you to take advantage of that. Feel free to reach out and ask questions.

We do various webinars and podcasts, provide information about different things related to technology commercialization coming out of university regulatory pathways and so on. We do have a few funding programs that were in place including the proof of concept ideas to products I2P which is no longer operational. But we had that program funded by an NIGMS as a supplement to our grant. And some of those technologies that we helped develop pre-company are now in SBIR funded space.

They are already created companies and have gotten funded. I just heard yesterday from Steph that the NHLBI just funded one of those teams. And what is the topic of today's conversation, we also have diversity programs, EnRICH, Entrust, and Engage. Next slide, please. So those are XLerate Network's signature diversity programs.

EnRICH, which is HBCU focused, engaging researchers and innovators for commercialization at HBCUs. Entrust, it is focused on Hispanic serving institutions. It's engaging technologists and researchers from underrepresented schools for translation. And our new program that is just being shaped right now called Engage, it's women focused entrepreneurial growth and acceleration with gender equity. Next, please.

Just a couple of words about EnRICH. You'll have the whole, full presentation after mine that Almesha will talk about this. It is an amazing program that is led by Jackson State with the help-- and Jackson State is a part of the XLerator Network and supported by XLerate Health and University of Kentucky. Great program.

Next slide, please That was getting a lot of attention, including from Forbes magazine. Like I said, Almesha will go into all the details of this wonderful program and testimonies of the participants. Next slide, please. Our next one is Entrust. As I mentioned, that is focused on Hispanic serving institutions, and having Puerto Rico as a part of our region of IDeA states provided us with a very rich consortium group of universities rech in-- not in money and funding but in wonderful ideas and great researchers, academic institutions in Puerto Rico. So our goal is to impact equity, diversity, and inclusion and innovation; train faculty and grad students and clinicians at those institutions; and provide various resources to develop, validate new life and bioscience innovations.

One of their most interesting programs that came out of that were Puerto Rico Science Technology and Research Trust which is the state lead for XLerator Network in Puerto Rico partnered with Columbia University in New York City piloted in 2021 and fully launched in January 2022, a life science focused XLerator program for Hispanic serving institutions. And it is a fantastic program. We help participate in judging their technologies that were coming through it and mentoring and coaching the teams that went through it, wonderful program. Thank you, Columbia University for being a great partner in that program. Next, please. The other one is our effort called SBIR/STTR Readiness Program.

It's also focused on HBCUs and minority entrepreneurs. It is led by XLerate Health with partnership from Jackson State, University of Kentucky, several INBREs in three states in Kentucky, Mississippi, and South Carolina and South Carolina Research Authority as the feeder programs for it. And this is a five week virtual course. It is funded by Small Business Administration Catalyst Award.

We were very lucky to get funded by this very prestigious award in 2021. This is one of seven of such awards, and that is a brand new award. We also were recipients of SBA Accelerator Awards for four years out of five that that program was running primarily in the last couple of years for support towards SBIR programs. Next slide, please. So that SBIR/STTR Readiness Program, we launched it in March, had the first cohort of seven participants.

It's a five week program that went through various background and the most foundational things for commercialization grants in general, customer discovery, reviewers perspective of different agencies, how to form an entity, researcher perspective and budget preparation, and helping participants frame how to move forward going into more intense programs that we have that are not just limited for minority participants. But going through this regional readiness program, our HBCU entrepreneurs are getting enough support that they may not have resources at their own institutions to get into more intense 10 week program where we would expect them to actually file their-- it's similar to AAP in their targeting, their stages, of the researchers and in terms of the services that are provided to academic researchers and innovators. Next, please. So here is their link to our website and my contact.

Please feel free to reach out, And I would like to pass the baton, next slide, please, to Almesha to talk about this wonderful program called EnRICH. Thanks, Eugene. Next slide, please. So as Eugene mentioned, EnRICH is Engaging Researchers and Innovators for Commercialization at HBCUs. Next slide, please. So the program was designed to basically focus on diversity and the inclusion of HBCU faculty and students in innovation and commercialization.

And this is led by Jackson State University with support from XLerate Health and the University of Kentucky. Next slide, please. So the goals of the program, as I mentioned earlier, is to impact equity, diversity, and inclusion innovations. And our goal is to train faculty and students at these institutions to critically evaluate the commercial potential of new health care innovations. Next slide, please. A bit about Jackson State, we're Carnegie classified High Research Activity University.

We're the only research institution in the state of Mississippi, and our mission is basically to provide quality teaching, research, and service at all the different levels as well as support our communities. Next slide, please. Initially, when EnRICH started, we focused on 31 HBCUs. Those are the HBCUs that are situated in the IDeA states.

But after the first cohort, we got a lot of interest from different HBCUs that are not in the network. And so we fully expanded the program very quickly in the next-- by the next cohort to all HBCUs across the country. And our very first cohort that was expanded included eight HBCUs, and we have expanded since then. Next slide, please. So our program outline is very simple. We want to introduce them to the goals and objectives of the program, talk about intellectual property, what that is, how to disclose.

Many of the HBCUs don't have established tech transfer offices so we wanted to do a little bit of introduction to that as well as the Lean Startup Methodology. So we did some of the I-Corps style training for four weeks of the program, and then we talk about leveraging the TTO and other support services especially for those that don't have a tech transfer office on their campus. What are some of the things that it can do? Who can they reach out for different supports. Whether it's within the XLerator Network or other networks, we're able to share some of those resources to them. And then we do a quick intro into startup formation and funding type. So this program is really trying to get their feet wet into this whole ecosystem and then guide them into other programs.

So this is a pre accelerator, and after they finish our 10 week program, as you see, week nine we teach them how to perfect their pitch. And week 10 we have a pitch competition, and once we go through this we make recommendations to them whether they need to pivot on the ideas, or they need to go into other programs within the XLerator Network, NIH I-Corps, NSF I-Corps, different programs that are more suitable for them based on what we've learned from them over the 10 week program. The pitch competition was just supposed to be a fun thing, but it ended up becoming very competitive.

And then we ended up having four different categories. And I'll mentioned that later on. Next slide, please. Our selection criteria is very simple. It's the potential for validation of their concept, potential impact of the stated, goal and the clarity and effectiveness of the video presentation.

So we ask them to do-- upload a brief video letting us know who they are, what their technology or idea is, even if they don't have an idea, why they want to participate in the program. And this provide us with some real good clarity about what their needs are and how we can support them through the program. And so as you see, we've had-- and this is about two years old, but over 50 participants and the faculty-- both faculty and students. And so far we've had two SBIR submissions and three intellectual property disclosures. Next slide, please.

So some of our instructors are instructors from the National I-Corps program. We have Grant Warner from Howard University and Marc Filerman from the German XLerator. They're the two that co-leads the four week of the I-Corps style training. Myself fill in most of the times, and then I have Angela Grayson who does a really good job of breaking down the patent system, IP, and all that stuff, making it easily understandable for these groups of innovators who may not have been introduced to it before. So very thankful for these coaches.

These coaches reach out to us and offer their support, and we have other supporters that comes in from time to time. But these are your core team of instructors. Next slide, please. And so the key members on the terms of leadership, myself. University of Kentucky would be Ian McClure and Taunya Phillips. Very instrumental in helping us ensure that we are meeting our goals and objectives, a lot of support to us to continue this program.

And of course, XLerate Health, Eugene is also on the board. And then we have Jackie Wilmott who is the CEO and co-founder of XLerate Health. Next slide, please. We do-- because our program is partially funded through the XLerator Network, we do have stuff where people can sponsor the program.

It can be through mentoring prizes, patent expenses, entry fees to accelerator programs. We try to support some of this. We were fortunate enough, Jackson State president sponsored the mentoring prizes and also the prizes for the awardees for the pitch competition. So we were able to support with cash prizes to the winners. We had winners in different categories.

And of course, our long term goal, our objective is to make sure the program is sustainable, and we want to ensure the longevity of EnRICH and its impact. As I told the XLerator Network, my involvement would mean that there is a sustainability plan in place, and if there was not one then I wouldn't be involved. Because it means a lot to me to have this program impacting the communities that I work in. Next slide, please. We do heavily promote the EnRICH program.

We have social media pages. We also make sure that every success that we have is publicized, reported to NIH, and reported to the various HBCUs so they are aware of what the faculty and students engage with with the program. Next slide, please. And these are some of our program-- some of our promotional pieces. We've had the EnRICH program picked up by different news articles throughout, as you see the ones before. But we also won a visionary prize from the lab to market for 25K.

So some of those funds were used to help support some of our coaches as well as support some of our prizes. So in our pitch competition, we have first prize, second place, and third place for our faculty as well as our students. And then our coaches select the coaches' choice, and it can be either faculty or student. And then we have a student star who may not be in the top three in terms of their pitch, but because of where they are from, what they've accomplished from day one of the program to week 10. so we just want to use this as a way to encourage the participation, and what we've had is the passing on of information about the program to others. So it has been very easy to recruit because the participants enjoy the process so much that they encourage others from their campus to participate.

And just briefly, one of our-- we do this on Fridays for 10 weeks, and one Friday fall on Good Friday, and I thought I would give them the day off because it's a holiday. But they all showed up. So I had to show up as well. That shows the dedication of them in learning what we are provided to them through this program. Next slide, please. And this is just a brief video with testimonials from some of the participants.

[VIDEO PLAYS] [MUSIC PLAYING] My name is Almesha Campbell, and I serve at the Assistant Vice President for Research and Economic Development at Jackson State University. And I also serve as the Executive Director for the EnRICH program. The EnRICH program is designed to engage researchers and innovators in commercialization at HBCUs, and it's designed for all HBCUs, both faculty and students. The idea came about when we talked about inclusion and diversity and how we get HBCUs involved in the commercialization space.

I chose EnRICH to get my senior project idea off the ground. I knew that I didn't have the necessary knowledge to bring an application into the market, and I knew that EnRICH would help me accomplish that. My name is Bryman Williams. I'm a licensed clinical psychologist, and I'm a faculty member at Jackson State University working in the Psychology department. I was part of the first cohort of the EnRICH program.

They took me within a few weeks and educated me on the terminology, the processes, the software that's needed to develop my idea and make it something that I could market and take to the next level. My favorite aspect of the program was being able to get my idea from up here and put it down on paper. And because of EnRICH, I see myself in the future working with pharmaceutical companies and developing a product that allows individuals to take more control of their own health. The EnRICH program actually helped me to discover what the customer needs. All the things that were taught in the EnRICH program helped me to build upon my initial idea that I came in with.

Others should choose the EnRICH program because it's a program that provides you a platform to actually test your results, to actually test your research to know whether it is something that can be commercialized. [MUSIC PLAYING] [VIDEO ENDS] Thank you, and I'll hand it over to the next person. Hi, everyone.

Thank you so much. My name is Melissa [? Quinn, ?] and I'll be facilitating the Q&A right now. So I will-- first of all, I want to thank our speakers for providing such an engaging and deep information about their program. It's really great. We do have some questions. So I'm going to ask those now.

The first question I'm going to answer myself. Several people have asked about the chat links and the presentation. We will be providing all of that information to you via email in the next day or two. So I just want everybody to rest assured.

If you didn't get everything down in your notes, we're going to send it to you. You will have it. I have a question for Dr. Campbell or Dr. Krentsel.

The first is they want-- one of our viewers wanted to know more about the Engage program. I know that that is in development right now. So they just wanted to get a little bit more information about that.

This is a brand new thing that is being currently developed, and if someone wants to help shape it, please reach out to us. We'll be happy to do that and talk with them about the best ways of doing it. This is a program in development. Great.

Thank you so much. The rest of our questions I think are primarily going to be for Meena and Stephanie. In terms of the resources and programs, for researchers in smaller institutes and universities, it's often very difficult to perform high throughput screenings. What kind of assistance can NCATS provide on that front? Oh, sure, happy to answer that. Well, first of all the Genomic Center is run out of our ETB program, what we call the Early Translation Branch within NCATS, and this is a part of the NIH common fund.

And basically, our intramural researchers would collaborate with investigators outside of the NIH and within NIH to generate probes, I believe, for studying a diverse cross-section of human biology, like focusing on new targets for untreatable diseases. And I'd be more than happy-- I mean, if you want to reach out to me, I'll be more than happy to connect the individual who asked the specific question with the right person in the ETB team. Great

2022-08-12 20:54

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