Support for Biotech Entrepreneurs and Researchers (with robust Q&A)

Support for Biotech Entrepreneurs and Researchers (with robust Q&A)

Show Video

Thank. You and good afternoon and, good morning to some of our folks depending on where you are I wanted. To point out the, closed, captioning, and GoToWebinar. Technical, support number if you have any questions, during the course, of this webinar please. Feel free to call those numbers I would. Like to officially welcome you to the impact, securing. Seed funding and support for entrepreneurs and, research I. Also. Want, to thank our collaborators, the. NC, Biosciences. Organization. And Virginia, bio and cast, pleased to partner with you on this effort. We. Have a couple of key objectives today, we. Would like to expand. Awareness, about the endcaps SBIR, and STTR programs. And. Other. Resources, to help foster innovation, we. Also want to give you some tips to help you be successful in up your application, and also. Ultimately, increase. The number of high quality applications. Especially in geographically, diverse States women and minority-owned businesses our. Job is to help you get the information you need to be successful and submit an application a. Quick. Overview of our agenda. We'll. Do a review of what. Are the SBIR, and STTR programs. Will. Provide tips we'll. Go through a case study and, also share some additional small business resources, throughout. The course of this presentation you. Can share with us your questions, by. Submitting, a question through the question feature. On the right side of your screen. Please. Feel free to continue to submit those questions and, we will address them through the. Q&A session, at the end. We. Usually get the question about whether this will be shared, after the presentation, and we will be sending an email to all registrants, so that you have access to this presentation, as well, with. That said I would like to welcome and thank our presenter, Lili. Portilla who's, a director of acetic alliances, at endcaps. Welcome. Lili. Thanks. Monique and, good, afternoon to everyone on on the, webinar I. Wanted, to. Tell. You a little bit about what, endcaps does in. Test. Of course is one of the 27. Institutes here, at, the. NIH, we are the newest Center, we were we. Started in, 2011. And, we conduct, and support research, on. The science and operation, of translation. To. Allow more treatments, to get the patient's quit quickly, we. Focus. On what's common, across diseases. And the, translational. Process, and. Identify. Bottlenecks in, the translational. Process and try to. Disseminate. That information, our. Learnings, to the public as well, and. In terms, of what translational. Sciences, is and how we define it here at endcaps. Translation. Is the. Process. Of turning observations. From, the lab and clinic to. Improve the health of individuals in the public, but. We, see translational. Sciences as a field, of investigation, focused on understanding. Scientific. And operational, principles, underlying. In each step of the translational. Process so if one.

Wants, To. Figure. Out how to do drug development in a more efficient, way we, would be looking. To see what in the preclinical, round, we could change, and and and, in effect and also in the clinical realm the. Same, thing would apply what. Can we do to address bottlenecks. In that part of the translational, process. So. If. You're familiar with the NIH SBIR. STTR, program. You, know that it's one of the largest sources, of early stage of. Capital. Print for small businesses, in the United States. We. Primarily. Get most of our applications, through, the Omnibus. Solicitation which. Was just. Released. This month. Standard. Deadlines. Are April 5th January. Excuse. Me April 5th September, 5th and January 5th and we. Also have a few. Specific. Solicitations. And targeted areas as well - as. Well as all the other instance, at the at the NIH have targeted, solicitations. And, once. A year we participate. In the SBIR, contract, solicitation. Which normally. Applications. Are doing the October, and November timeframe. So. What. Are the SBIR and STTR programs. SBIR. Supports, early-stage, R&D. Projects. That small businesses. STTR. Help small businesses, formally, collaborate, with you, know research institution. For. Phase one and Phase two and, and, when I refer, to phase one and Phase two those. Are parts, of the SBIR. And STTR program. I'm not referring to what, FDA, qala calls, of Phase one clinical trial. Or Phase two clinical trial, and. Again, the. SBIR and STTR program. Helps entrepreneurs with. Early stage t2 siege of seed, funding. So. In. Terms of what endcaps is interested, in we. Our topics, of interests, are focused in three, buckets, one. Is drug discovery, and development tools. Another. Is biomedical. And clinical health. Research informatics, and tools. Related to that and, clinical. Dissemination. And implementation research. We. Fund, tools. And technologies, in that area, and if I have time at the end of presentation, I can briefly, show you what some of these specific topics look like. So. SBIR. STTR is. A congressionally. Mandated program. Which, all, most, federal agencies, participate. In to. Set-aside program, meaning that we must spend, our funds. 3.2, percent of, the. Total NIH, budget goes, towards. Small. Funding. Small business. SBIR. Program, and point forty five goes. To funding the STTR, program. So. Again let's talk about the three phases of the SBIR, STTR program. There's phase, one which. Is typically, a feasibility. Study and the fudge guidelines, for the programmer. 115,000. For sbir/sttr, and. The, project, period is normally. Six. Months to a, year for. STTR. I. Want. To point to the budget, guidelines, here, at the, NIH, we will go up to we do have a hard cap at two, hundred and twenty-five thousand. For a phase, one phase two and. 1.5. Million for. A. For. Phase 2 the, phase, two is. Full orangey. And again. The. Guidelines. Call for 1 million but we can go up to 1.5, million for SBIR and STTR and, it's normally for a two-year, period of time the. Fast-track. Is. An. Application. Process that combines both the phase one and phase two so, you're applying for what. You would do under a phase one grant as well as the Phase two. Meaning, that you don't have to go through the review process again, but you do have to show progress in the grant and we would be looking at that before, you, at. The time you completed, your phase one specific. Games and moved over to a Phase two and. Some. Institute's, here at the NIH, participated. In the program called, phase 2b which is a competing. Renewal program. We. Have, a base. To be program, we. Do ask our. Grantees. And we'll only fund those grantees, where we funded the phase to grant but. It's. Important, that you talk to us before you submit a phase to a competing renewal, because. We want to make sure that we can support the program going forward and, your, application, phase. 3 is what, generally. Is, what. Happens. You know after NIH provides, funding, in the phase 1 and phase 2 arena. That's. Your commercialization. Bage we're looking, for folks to start for strategic. Partnerships, and potentially. Get follow-on, funding from other sources. So. Here at. The NIH our overall, budget, is, I. Think. This is 2017, members we're looking at here is was thirty three billion so the, NIH, has had, again. Congressionally. Mandated set-aside, for SBIR and STTR totaling. Almost. 1 billion dollars, that, we that, the Institute's, across the NIH are, using to support small. Businesses, here in the US. So. In terms of eligibility, for SBIR we. The. Criteria, for applying to SBIR, is that you must be a us-based. Company with 500. Or fewer employees the. Pis primary, employment is with the small business at the time of a warrant and during the entire duration of the project.

More. Than 50%, us-owned. Of. The business must be owned by individual, individuals, or independently, operated, or. More. Than 50% can be owned and controlled by other business, concerns. That. Are. 50% owned and controlled by, one or more individuals or. The other scenario is that more than 50%, owned, by multiple venture capital, operating, companies hedge funds and private equity, firms and and, if the, eligibility, really, comes into play at the time of award so all these points. Here will be, cross-checked. At the time that you are, slated. To get the award so we want to make sure that at the time of award that you have that. You meet all of these eligibility. Criteria. For. STTR. It's a slightly, different it's. An established. Cooperative. An established, cooperative, and development, effort needs, to be delineating. Where at least, forty, percent of the small business, concern, and at least 30 percent of a u.s. college, or university, or nonprofit, organization, is. Part of the collaboration, you, need to have a formalized, IP agreement. At the time of award that, shows. That you have the necessary intellectual. Property, rights to carry, on. At the RNG. And commercial, net commercialization. Aspect of what you're putting together in the grant and the. Primary, employment of the principal, investigator, is either with the small business or the, research institution. But, the award always, goes to the small business and either one of these scenarios. The. Benefits of the SBR is teaching our program is as. I've said before that it's one of the largest funding, sources. For. Early-stage life, sciences, in the country, it's stable. And predictable again, because it's linked to our overall. Budget IP. Rights, are retained by the small business we, do not consider this alone, or. Expect. You to pay it back and it's so it's non dilute of capital, and I, think one of the added. Benefits of, the program is that your project. Goes through rigorous, scientific peer, review process, which many. Of our awards awardees, leverage, to attract additional funding. And. Sometimes, they can do it simply by showing their, summary, statement, and the very.

Competitive. Score. That they received, in order to get a follow-on funding from other sources sources. So. This, this, slide shows a a good. Representation. Of the differences, between the, two SBIR. And STTR. SBIR. Permit partnering. But STTR. Again requires, that you're collaborating with, a non-profit research institution. Here in the US. The. Work requirements. Are a little bit different in, terms of outsourcing you can, outsource. 1/3, 3%, of the phase 1 and 50%, of the phase 2 award and the. Minimum work requirements, for an STTR, are as I said 40%, to the small business and 30%, to the research institution, partner and the. Difference, between the principal investigator, is that the, primary employment, for that principal investigator, can be. With. An SPG are either with a research institution, or the small business with, the SBIR it's always with the small business but I will, add that you can have multiple. Pis. Under, an SBIR, award. And, those, multiple, and those pis can also be from research, institutions as, well too but. Again the award is always, made to the small business, not the academic. Research institution, i. Intact. For. The most part gets the, most. Of its applications, through what we call the omnibus, parent, SBIR STTR grant. Solicitation. We. Encourage, you to look. On our website and see the different, types of topics that we. Look. For here at endcaps as well as what our other sister. Agencies, and institutes, look for there, is a very helpful, web, link within the. Solicitation. Called the program descriptions, and research topics, it's a very comprehensive, document, almost, 200 pages of topics, across all of, the, 24. Institute's, that participate, in the program as, well as our sister agencies, in the CDC and FDA, and. Again, the standard deadlines, across the board are our April 5th September. 5th and January, fit. In. Terms of your your criteria, it's very similar to what you might find within an ro1. Grant. We. NIH. Is going to. Peer. Review is going to look at. Scoring. The significance, of the grant you know what, what's the commercial potential, of what you're proposing what. Your. Investigative, team what what does it look like you have the right expertise, in place, in. Terms. Of innovation is this an improvement or is, it a brand. New approach to, a particular, problem. We'll. Look at your research design and, the. Feasibility of what you're doing and again also, assess, your research, facilities. And and resources. That you're going to be bringing to the table, we. We may review, but not score, individually, things like protection. Of human subjects, inclusion, of women and minorities in. Clinical. Trials, and vertebrate animals and bio. Hazards again, typically. These. Are not scored that these will, occasionally, be commented, on by the reviewers. So. How long does it take to get an application funded. So, if, we look, at the next, solicitation. Date which is April 5th. You. Submit your application by then and you can, expect scientific, review to happen sometime in the June July timeframe. Our, council, will meet in either. End. Of August or beginning of September, and then, we. Would probably, not be able to award the, grant, probably. At. The. Towards. The end of the fiscal year which is a September, timeframe or, perhaps. Into the next fiscal year which would be more, in October, so. We're. Talking anywhere, between 7, to 8 months and making an award at the time you, submit the application at, the time that we can. Go. Ahead and and you'll, get the money for the award. One. Of the things that I'm. Just going to go through some tips in terms of how to apply, to the program I think, one of the key things and that, should have most of the information about the, specific, funding announcement, that you're applying is to read that. Announcement very carefully, to make sure that the, focus, of what you're doing really is aligned with the funny announcement, we, are required, to put down points. Of contacts, to have discussions, I encourage. Folks to talk to. Program officers, before they apply to make sure that what they're applying to really make sense for that specific, funding announcement, or Institute. But. There's also if. You go on the NIH. Website there's, a very. Handy, resources, tab that you can actually pull up a successful. Application. One, of our grantees, has made. That available for the community to look at and you can get a sense of what a successful application, looks like. Also. You might get a might. Want to look at the NIH reporter. Which, is a comprehensive. List of all grants. That the NIH has fun grants and contracts that the NIH is funded. Excuse. Me awarded, and you, can get a sense of what types of applications.

An, Institute, is is currently, supporting. And. And all that information, is made to the public and I guess this gives you a good sense of to, understand, what is the specific, Institute, is looking for. And. See the differences, between the, various Institute's, at NIH in, terms of what they, would support and funding in their SBIR. And STTR, portfolio. And again. I can't stress, this enough that you really, should, be engaging with them one of the Institute program officers, early. In the process again, to make sure that you your, application. Is, a good scientific. Fit for that, organization. You, also may find out from them about specific. Initiatives. That and, targeted, solicitations. That are, perfectly. You, know you. Know set up for you to apply to because they they. Address the problem, that you're trying to. You. Know put, together in your in your grant and, I would suggest, having this conversation again, early at least a month before the, due date, we. Are very busy I, would, say three, three, to four weeks before an application date. When, your swamp was called and, it's. Best to have those conversations, early in the process because unfortunately you may get, into a situation where, you're not able to have a. Conversation, with, some of the program officers, if you wait you want. Another. Of some. Other tips are is to register earlier, early, for the SBIR. STTR, electronic. Submission, process. Use. NIH, assist which is a. Tool. That we have that streamlines. The application, process this is a really useful tool especially. If you have. Never applied to the NIH it kind of walks you through the application, process. You, can also specify, the. Institute, that you would like to apply to so if you speak to me and I tell you that the application, is a really good fit franchise I would. Encourage you to list intact as your primary, a Institute. And. That would go for my other. Institute's. Here if you once you speak to the program officer, and you know that it's a good fit you know put. That down in your request. Form and also. Check, out the list of study sections, that the Center, for scientific review has, on their, website and. You can get a sense of the types of applications, that these study sections, are, reviewing. You, can also get a sense of what the roster, looks light and who, is, participating in, the review process and again, submit. Early, not. Days, and hours before the submission process I it's. A it's. A trapdoor that many of our, that, we see are. Some our applicants, get into. Which is that they wait for the last minute and then there is some issue. With their registration, or the pagination, has, kicked, the application, out because there's too many pages so, these. Are things that you can fix, if you submit. Early. As opposed to submitting, you know hours and a day before the application. Due. Date. So. I think, this. Slide. Here summarizes. What we view, as the common application, problems, I think, one of the ones that we see the most is that the, reviewers, believe that you, know if it's, a nice solution. But it doesn't, you don't make a convincing, case for what. The commercial potential, or the. Biomedical. Impact, would be on on what, you're proposing. On. Also, we see comments. Around lack of innovation.

Diffuse. Or unfocused, research plan going in a lot of different directions I mean you have to make sure that what you put together is to measure it with the budgets, that are required. Limits. That we have for these programs. We. Also. Have. Seen that there's a. You. Know related to that there's an unrealistic, large, amount of work that people are proposing, that just cannot be done with the budgets that that you are expected, to get under a phase 1 or if they - a. Lot. Of comments, that I have, seen in the past have to do with the investigative, team that's been put together you, don't need to be a PhD or MD to, apply this program, but, if you are going to be doing you. Know clinical, research you should sure. Should have a proper. Clinician. Involved, in the project, that has the right expertise, to carry out those. Specific, games where that expertise, is needed. So. Important. Fact to remember about, the program, again. Eligibility. Is determined at. The time of award. Specifically. For an STTR. I also, want to say that that IP. Agreement. That you need to show that you have access to the intellectual property. Does. Not need to be in. Place until the time of award so at the time award we will confirm. Whether. All these that, you're still, eligible. To. Receive the award that, you have proper, IP agreement, will, make sure that you have proper, lease with, with. You, know an incubator, or wherever to conduct. The research I. As. I said that the p i-- is not, required, to have an MD or, PhD but. You are expected. To have a proper, team, with the right expertise, to oversee the projects. In place and, you. Can submit. Applications. To, different. Agencies for similar work but. There, really should be no overlap between what NIH, is funding and also perhaps what NSF, is funding. So. I think. It's. One, of the I. Guess. Comment. That we also get is you know once you submit and you get a score and you find out that you didn't, get reviewed, or, the score was not that great what. What do you do and I think again it's. It's critical, that you discuss, that summary, statement, with your, Mah. Program, officer, to get a sense of what to do I think the. Summary, statement, serves as a great. Guys. To. Resubmit. Your application and. Follow some, of the comments, that they've made. We've. Also put here a link, to the CSR, website so, you can get an understanding of, what the review. Process and dynamics, look like and. I. Think. In, terms of resubmitting. An application, spend your time, carefully. Reading that summary statement, and then, addressing, those concerns and revising, your aims page, when you resubmit, the application. We. Want to make sure that you have all your, grant. Registrations. In place before you submit some, of these registrations. Can take up to six weeks to complete, so that's why you need to start early and, there. Are five different registrations. That need to be in place before you submit any grant for the NIH, and. They're. Listed here and if you go to the website that, we've that. We've put here you can get a sense of what they are and for, instance, the the, Sam. Awards, management, system which is the way, that you get across. The government that you get payment, from the government and this. Is how the system that you would be getting your award that, that. Registration. Alone. Can take up to six weeks because you, have to have your. Tax. ID, number in place before this. You. Get this registration, in place and it does a check, those, what. You put in with IRS. Systems, so that can take a while to do and you cannot submit any, application. To the NIH until, all these. Registrations. Have been completed. Very. Quickly I wanted to talk about one, of our success stories here at and cast. Anchor. Is a. Company. That we funded several years ago it's, a medication.

Adherence, Tool. That. Uses. Artificial intelligence to. Come. Ferm that, a patient, has taken, medication. And this is really. Critical. In. Terms of patients, or folks. That participate, in clinical trials making, sure that they're adhering to the medication, schedule that specified, in the clinical trial I wasn't, aware of this but this seems to be a problem that even, though people participate, in clinical trials sometimes they're not very compliant, with taking their medication, but, this. Artificial. Intelligence app, is. Able to assure that patients, are taking their medication so. What this, company did was that they received two SBIR, awards, from endcaps and they were able to attract, and leverage an additional, 12. Million in financing, from from, VC investors, and as, a result, of that they were also able to, leverage. Several. Strategic. Partnerships, with large pharmaceutical companies. That do. Clinical. Trials as well so this. Is a great, example of how to leverage, your SBIR. Award, into. Hopefully. More financing. From other sources, other than just the government. Very. Quickly I'll go through the other. Funding, sources, for small, businesses, here at, the NIH, NIH. Also, offers, entrepreneurial. Support, and, courses, for Phase one awardees. We. Have. The iCore, program. Where. Our phase one grantees, can participate. Are. Some. Of the other Institute's also participate, in one that's geared specifically. For medical, devices with, the Coulter foundation. Here. At endcaps we have a program, called bridging. Interventional. Development, gaps the bridges, program which. Is a collaboration between, our intramural, and extramural lab, and, Nishimura labs it, was formerly, called the NHRA program, but, here, the, purpose of this program is to get, the. Risk program so that they can get to an IND filing. And we what, we do is we provide, a gap analysis. To figure out what they, needs to be generated, to get you to that successful, IND filing, we. Folks. Enter this program when they have a clinical, candidate, identified. In any, disease, area, and modality. As well is. Eligible. To participate in, the program. Academic. Not a small, business, SB are eligible, companies, can participate in this. Risking, program and. I want to stress that this is not a grant program it's a resource, program, so what you're getting access to is expertise, and resources. And, I'll give you an example of how that works in a few minutes okay. The, next program is the therapeutics. For rare and neglected diseases program, trend. Trend. Actually, can get you passed an IND filing, up to a phase to, a clinical, trial, the. The, difference between trend, and bridges is that you trend. Only, takes those diseases, that, meet. FDA orphan. Drug designation or. W-h-o neglected, tropical disease, criteria, so you either have to be in the rare or neglected disease, space to participate, in this program and. It's. Open to small business, academics, and. Also. Outside, the US as, well - and, here we do. A cap gap analysis, on what you need in order to get, your. Drug. Or whatever it is to the next stage so that you could get a strategic partnership, or a key inflection, point whether it be, more additional. Funding, and IND, filing, whatever that is you. Work very closely with our project. Managers, and our, team. Here, in, providing. Some of that assistance to get you to the key. Inflection, point. So. Here's an example of this, is an actual example of somebody that participated. In the program this, was an academic investigator. Who has developed a new. Compound, for a treatment, of a rare disease and they had done. Some of that early, stage research using, ro1, support. As well as. Our funding. That totaled, up you know 3.5. Million dollars they. Went to the FDA in. Order to file the IND and the FDA said to them that they needed these two, clinical, two preclinical, studies toc. Studies done in order. To get them to the to an IND and and, this particular, investigator. Had a really hard time trying to get these, two preclinical. Studies done. Typically. Not something that you can do under an ro1 grant, and they just had to you, know they totaled, up about half a million dollars so, they came to the bridges program who.

Helped Them get. The studies done and as a result, of that they successfully. Filed an IND and we're able to raise around. Fifty million dollars in BC, Series. A funding so, this, is how this. Particular investigator. Leveraged. SBIR. STTR money. And then came to bridges to kind of help them through. This valley of death. So. With that I'm going. To stop and. See. If we have any questions, Thank. You Lilly we have quite, a few questions, thank. You for that presentation. One. Question is there are SBIR. And STTR s, across the NIH how. Do we know which one to apply to if our technology touches, multiple. Disease areas and what. My application, be forwarded, to another Institute, if there's a benefit so. I'll. Speak. Specifically, to how I do we, work here at n tests we. Encourage our, applicants. Before they submit an application to, us to to, talk to us to make sure the number one is a good fit if you're, not a good fit for n test I will suggest, to you who to talk to at, some of the other institutes and yet, sometimes. Applications. Expand. Across various. Institute's, and I think that's we're having a conversation with, the program officer is so critical. Because, what you might find out and that conversation is. That one. Particular Institute. Sees that as a very, high priority, once. The application, and that's communicated. To you and you. Can have some, of the other Institute's, listed, as secondaries. In the event there's co-funding. That's. Needed, or. You. Know, just. To show that there's other interests in the application, so again. Having. That conversation early, to determine which. Institute is the best fit and who is most, enthusiastic. About your, application is, so. Critical, to finding the right home for your, application. And hopefully eventual, funding. Thank. You Lily the. Next question, is about the. Success rate for SBIR, and STTR and, tax is there a current pay line. We. Are pay line being, that we are a new. Institute. Compared. To the rest of NIH, we've been around for six years our pay line has been, shifting. A lot and what, I mean by that it has gotten very competitive. Whereas, we may, have looked, at you. Know. As. An example scores. Going. In the in, the early in the. 40s. We are now looking for scores, funding.

Scores In in the. In. The, 30s and that's changed, again because people are applying it's. Become more competitive to apply, to us in terms, of success rates that's made public, on the NIH website so if you wanted to get a sense of what that, looks like, you. Can go. To the NIH website and, see what the different, success. Rates are across the Institute's, for, the various funding mechanisms, at NIH has and. That website is SBIR. That aah-aah. Class. Statistics. Slash. Awards, - data and I'll also include that in the chat. The. Next question is about fast-track, does. This mean that the combined time frame is two and a half years with a budget guide of 1.15, million, or. Is it not additive, so. For, a fast track. The. Yes. The the time period, would could be. For. Your phase one six months, your. Award, for, that would be. Two. Hundred and twenty five thousand. And then, for the face to the. Time period could be a you. Know two years, with, an award for. The phase 2 of 1 point 5 which is the NIH hard, cap so it's, 225. For, the phase 1 and 1.5, for. The phase 2 and and, one thing that I did not mention which is very important, I talked. About the. Program, description guide, that's linked. To the Omnibus, solicitation. There. Are some topics across the NIH that NIH, has designated as, high priority topics. Or, topics. That we believe, that the, current budget caps, cannot really cover the, work that's done so, there may be waivers. They allow, you to go above, the budget caps of 225. And, 1.5. For the phase 2. So, we, again, we encourage you to look at that document because for. Example is. At end caps if you, look, at our waive topics. List that we have in that document, what, you might see what you'll see is that we do for, these waive topics, we will allow up to 325. K, for. The phase 1 and up to 2 million for a phase 2 but it has to be in the, specified, waive topics, in each Institute, has, their own topics and their, own budget, limitations, so again read that document very. Carefully. Regarding. Your specific project. Area, that you're looking at thank. You. And. This question is about rejection. If, an application is rejected could, you provide guidance, on the pros and cons of doing a resubmission versus, in the proposal, I. Think. Again. Based on my experience, with our grantees, that we find have funded, here and at MCAT. I would. Say the majority, of, them go, for a resubmission, of, the, application. And a. Significant. Amount of them and end up scoring, better than what they did before, and they use that summary statement, as their guide. To. You. Know, beef, up the application and I'll add that review we'll look. At a resubmission, and make sure that you've been best some. Of the concerns that the earlier review, had, when. I have seen folks. Do a different, application is, when they're really going to change the focus. Of the. Application, their specific, games are going to be a little they're going to use a different approach and, that. Could be because the, review it, intimated. That that's what they should do so, I think. To. Say that one versus, the other. It's. Best that you kind of look at the. Totality, of what you're trying to do if you are going to go in a different direction and, and. Change the specific, aims significantly. Then maybe perhaps a new, submission, is the way to go and the. Best way to proceed, is probably just having a conversation with the program officer who. Can guide you on that thank. You, what. Types of projects, typically get get funded, for phase one for a new drug is this for preclinical.

Animal Testing. And Phase two funds. For. Phase one clinical trial, of human. Again. Based on in Katz's experience, we see. Preclinical. Development in, the phase one but we also see it in the phase 2 because we, know that developing. A, novel, compound, it's, the long haul and we, don't expect people to. Do. Be doing clinical work in in, their face - unless of course they're, getting some. Additional, funding from other sources but most of the companies that we fund are continuing. Their preclinical. Development in, the. Phase. Two, of the part of the award and, I'd like to add that, it's, important, that you, check with the Institute. That you're applying to and, specifically. Here at endcaps, we, are not, accepting. Applications. That are doing, clinical. Research as defined, by the FDA in our program, other, Institute's. Have different. Policies similar. To ours others. Will only accept. Clinical, trials under, specific funding, announcements. So, if that's, a direction, that you. To be headed in, with. Your espares, PTR it's, again important, to check with that respective, Institute, that you're applying to to make sure and understand. What their funding, policies, are and if, you look at the new omnibus. Solicitation you're. Going to notice something different which, is that, there is a, clinical. Trial accepted. Funny. Announcement, and one that does not accept clinical, trial so you need to look at that carefully as well too related. To that if, you get funded for one Institute, for a particular, Thais may, you switch to, another for. Another phase for example if they want to start off with intact and then, when they get to the clinical trial phase move to another Institute, at that possible, yeah. It is possible and I. Would, also add. The caveat that in that instance, it's good to talk. To the other. Institute, that you intend to shift the application, over early. To make sure that there isn't an issue with doing that. Some. Institute's, like. To see continuity. And their funding in terms of funding phase ones and phase twos. Summon. Some, Institute's don't care for. Us in particular we. Have accepted applications. From other that. Originally. Started as phase ones and then come here to isn't phase two but, that's because it was a good fit for us and it made sense and we had. An offline conversation. With the other transferring. Institute, to make sure that they were okay with it so. Contact. Your Program Officer for guidance, in that area. So. The next set of questions relate to this company, and the team that we put together can. You tell us more about the role in nonprofit, can play and leverage, and the SPF, var, and ICT our arena, so. Nonprofit. Can mean. A nonprofit, is not precluded from working, under an SBIR, or STTR. I, will say that an STTR. Does. Provide. For the collaboration, to happen directly with that research institution. And. There's many ways that they can be engaging, with the research institution. That particular investigator. May have, specific, expertise, or a a. Very, novel. Animal. Model, or access. To patience so there's different ways that research institutions. Can participate but. It's not to say that under an sbir, that that scenario couldn't, happen again it's just that that particular. Research. Institution. Is, not going, to be the, principal. Investigator, of the grant they could be a COPI, I perhaps. But. It would really depend on what is going to happen under the grant and. Again, that, conversation, with the program officer is really key thank. You. Foreign. Spt, are can apartment, research institutions. Be a non-us. Academic, research institution, that's. A really high bar in, our experience, we. The. Main, focus of sbir/sttr, is, to really fund. You. Know us-based. Small. Businesses, and research institutions. In. The event of foreign. Institutions. Being involved, it would have to clear. A hurdle, of from. The perspective, that there is something, unique, that, that institution. Can only offer so. It. Could be that that particular institution, has. Let's. Say the application, is is around the area of rare diseases, and, that particular. Non-us. Based institution. Has access, to a significant. Amount of patients. And that. Have this rare disease an exception. Could, be made around, that, but again it's a really, high bar and we look at these on a case-by-case, basis. And I would say for the most part that, those are exceptions, rather than the norm for, under. With. Our experience, here in the program thank, you, one. Of our participants, has a company, based in the US but the founders are not American isn't that does that not count as 50 percent American, even if the main investigator.

For The grant is American. Just. To some background, the work is going to be conducted, in the US and the leadership of the company are international. Founders. So. The, P i okay. Must. Be a US. Company. Organized. Here in the US the, P I does not have to be a US citizen. But. The company needs to be done here and the work needs, to be done in the US so. Based. On the fact pattern that it, was just given to me I would say that would be okay but you know with that said that's. Probably a good conversation, to have a good head of time with your specific. Program officer. What. Is the minimum size of a team as a faculty researcher. And postdocs efficient for example. It. Depends, it depends, on what, the specific, aims of the grant are what's going to be done, it, could, be enough but. That's. A hard question to answer without, looking, at what's being contemplated, under, the grant. Thank. You, what's. The difference between multiple. Piata and copia. Multiple. VI is exactly. What, you. Know it says there's there's a various. Principal, investigators, involved with a grant bringing, so specific, expertise, to the, collaboration. That's going to be done under. The SBIR STTR grant. A COPI, I is. Listed. As a COPI, I so it's some investigator. Smith from you. Know, representing. The small business, and perhaps. Investigator. You. Know Portillo doing, the other work and there. Is there's, one that. That small business P is going to be, predominantly. The point in contact, for issues regarding, the grant but you can have more than one listed. Formal. PI on the grant. Thank. You. Is. There. A minimum size of a team and. Then also. Doesn't. Need to be evidence, of experience, and commercializing, research, how much experience, is necessary. I'm. Not sure it's if the evidence is, of, commercial. Of experiencing, commercial is isis commercializing. Something is is, critical. What, i, and I'm, not going to say, that that's not important, but I think what's more important, is that you, can. Demonstrate that, there's a you, have there's. A commercial need, for your product, and, that's going to be looked at when you when, you do your face to a big part of that application, is the commercialization. Plan and. Doing. Your research on that and that doesn't necessarily. You. Know say. That you have to have commercial experience is just that, you need to explain what your commercial, market is how, you intend to get there. Who. Your potential customers, are and things like that. Thank. You the next set of questions relate to IP. Non-dilutive. Funding, was listed, at the benefit, of the program to. Confirm well, and test not take ownership of IP and the funds do not have to be paid back to ingest that's. Correct, the. What. You invent is yours we. We. Are not asking, for reach, through to that intellectual, property. Regarding. IP does it mean that the company must have a license, at the time of award or a letter from the University saying that the company, is in negotiation. Phase is that sufficient and. We, would want to make sure that you have access so saying. That you have your in there negotiate. The time of award okay so let's, just to, be specific at the time of award we want to make sure that you have access to that IP so, we want to get a letter saying that you have a completed, license, and. That you have access to it under, negotiation. I. Don't. Know I don't, think that that would pass muster here, at endcaps in terms of meeting that requirement. Thank. You a, few. Questions about funding focus, can you provide tips, or guidance for transitioning, from a phase one award or, applying to a Phase two grant. So. As. I said the phase one was, feasibility. Studies, and remember, the dollar amount is 225. For a hard cap so. If. You if you look. This, is where looking, at that application that we have on site actually would be really on our, website might be very useful because you could get a sense of what those that applicants, did and their phase, one. Feasibility. Studies the types of things that they did and how they transitioned. Over to the Phase two which, you, know, included. More specific, studies that they needed to get done and things like that. Each. Project is going to be different in terms of what the end game is so. Might. Be good to talk to your program. Officer about, that to. See. Award grants focused, on early stage of coaches, or methods, for drug repurposing. We. We, we. Do yes, we do we we do. Like. Repurposing. Programs and I will say specifically. That, we. Like. Repurposing. Around rare diseases, that's an area of great interest to end cast. Around. The. Repurposing, issue I just want to say that if your program, had a really.

Really, Strong, oncology. Focus, I may. Think that you may be better suited to go to NCI, as opposed to end text but that's why having. The discussion, with us as an initial discussion, might be a good. Place to start. We, would want to know what class of diseases you're looking at things like that so, but repurposing. As a whole is of, interest to us if you're purposing, for rare diseases that's, even more that's. Definitely in our sweet spot, can. You share more information about, what funding, can be used for for example can it be used only for direct, R&D cost can some portion be used to cover, a company, salary. Some. Salaries, can be covered and. That's. All that, that guidance, is provided on. The, NIH website in terms of how much of that can be covered. And. If you're going to be contracting. Out it also specifies how, much you can contract, out to third-party, sources, and, there's a limitation, on that and then again it's going to get looked at very closely at the time of award to make sure that your when your limits. When. A company gets. Notification. That they have been accepted. How. Do you drop an award agreement and how's that paid out is that loved sons monthly, by milestone. So. The, award. For, the phase one is going to be made in a lump, sum and then you're expected to provide a report. You. Know at the end of your board and I'm assuming that your meeting that you're going to be doing this within a year's time frame okay if we're face to it's multiple, years so every year you would be, expecting. To get the. Next bolus. Of money based on what your yearly, budget, is that. You've delineate, it in your grant and, before. That award. So. If you have a Phase two and it's a multiple year well it's a multiple year award before we make that award, we want to make sure that you're on target the things you're moving along and the program, officer, would. Informs. Our Budget Office and then that those monies are made available to, you for the following year. Would. It be reasonable to apply, for a phase one SBIR. To do toxicology. Studies of, a drug in order to apply for an IND and. A Phase two for clinical trials as a, fast-track applications. Without. Knowing, too much about the program I think that's. Possible, but I guess we'd have to look at you. Know the specific it, when. You talk to your program officer I think in situations, like that if you already have a draft. Specific. Aims page I think that's the kind of thing that you would want to share with them to get so, that he, or she can provide you the best advice in terms of the approach that you want to take and putting the fast-track together, thank. You, we. Just went through a series of continuous, resolutions, as to SPR program. Funded, regardless. Well. You know yes. It is funded, yes.

We Are under a CR. Which. Means that we're working on with, last year's under, with last year's budget if. Things change then, we'll readjust, that towards, the end of the year because we do still. Expect to have a. You. Know that resolved sometimes this fiscal year there. Are. Institute's. That may, not be funding, grants to they're at. Their full amount because they're still waiting for the, CR situation. To get settled it really depends, by program. And by institute, but. Yeah. I'll stop there so. This question relates to states. That may be an EPS cord state or an idea state that, may have, a geographic, under-representation. And. IH, funding, they, want to know how do you find experienced, people to help support and run, these to, help support the applications. For these grants they. Don't have some, of the expertise. In this area like some of the larger states. That's. A great question and I think I. Would. Work closely with my. Colleagues that, run the idea program, here at NIH, to find, out if there's some resources, within those. Idea states that we that, that, you know maybe perhaps you don't know about state. By organizations. Maybe another, resource. As well I, know that some of them do provide some mentoring, to small business, companies. So. That's. Probably best, answer with a conversation. Two. More questions came, in for. Topics we previously covered so I'm going to go back to the, teaming, can. You have a remote team or collaborators. And does a team needs to be owners in the company. No. No, the, teams don't need to be owners in the company. The. Team is how. That's going to be looked at is whether you have the right scientific. Team assembled, to, do to, perform the specific games of the grant, the. PI as, I mentioned earlier does not need to be an MD or PhD but. If you are going. To be doing I, don't know some. Toxicology. Studies on, there do, you have the right expertise, to be able to provide you advice on that but that's going to be looked at when it comes to review, thank. You we, will take one or two more questions but, I'm going to have us turn to, how to contact us we really. Do want to make sure that you're getting the information you need to be successful and determine, if, the, endcaps. SBIR. And STTR programs. Are appropriate, for you I literally, mentioned, we. Do take, input. And are, here to answer your questions. So in. Addition to the Janelle. Websites. And our social channels you can also email us directly at and, catch that -. Sbir/sttr. At. Mails at nih gov, now. I have one. More question. The. Question, is is having options - IP over, time of the. Award enough I just want to ask more, specifically. So. IP options. Um, I. Think. If the University or the research institution, can explain, what, you know what, that option is and to. Us I think that that. That that, could be sufficient, but. I guess, we'd have to wait and see on that specific, case you know so. We. Need a little bit more information but we have seen options. That. Have been granted by, the research institutions, be sufficient, enough to address. That IP issue, thank. You so. I did, want to note that we are at, the conclusion, of all the questions we have received we. Have really tried to make sure we answered, as many as we can but. If you do have other questions please, email us also. Your feedback is really important. To us so, there is a. Request. For your input, right at the conclusion, of this webinar with. That said I would like to really again thank our collaborators at. NC. Bio as, well as VA, we. Couldn't have done this without you and I also want to thank Lili Portilla for, your patience, and going through every single question again, if you do have more we're, here for you please reach out to us thanks.

Monique And thanks to everyone who participated and. If you have any questions, feel free to reach us. You.

2018-03-21 02:14

Show Video

Other news