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Support for Biotech Entrepreneurs and Researchers

Support for Biotech Entrepreneurs and Researchers


[MONIQUE LAROCQUE]
Good afternoon and thank you for joining the NCATS SBIR/STTR webinar. This webinar, Securing SBIR/STTR Funding
Support For Entrepreneurs and Researchers, is brought to you by NCATS, as well as several of our partners. Before we get started, I want to
share a few housekeeping reminders. We will be accepting questions and comments. Please feel free to chat them
to us throughout the webinar. You can do so on the right control panel. There is a Question section,
and you can type it there. We will be answering them at
the end of the presentation. We also have closed captioning, and I will
record this presentation, which we will be sharing after this meeting. We will send it to you in an email. If you would like to access
the closed captioning, please do. If you have any technical difficulties,
please also reach out to us via chat. So now we’d like to thank all of our partners. We have several here with us. We have Life Science Washington, Montana Bioscience
Alliance, Bio ND, the Oregon Bioscience Association, and New Mexico Bio. Thank you to our collaborators. During this webinar, we’re going to be talking
about awareness about the SBIR and STTR programs at NCATS and supporting other small businesses
to help foster innovation and technology development. We’re going to help provide you tips that
are going to support your small business organization, as well as your research organization, to be able
to successfully apply and access NCATS resources. And our ultimate goal is to be able to increase
the number of high-quality SBIR and STTR applicants, especially among geographically diverse
states and women-and-minority-owned businesses. I do want to acknowledge that we have
several bios from our IDeA states, and we thank you for joining us here today. We hope that you do consider
applying for these programs. So, during our meeting, we’ll give you an
overview of the program, provide tips for a successful application, share case studies, as well
as offer some small business resources to help you. We will also have a moderated Q&A. I would like to also ask you in advance to
send in your questions via the chat, if you would just hang on for a minute or so
after the webinar, there will be very, very few questions that will pop up. We really value your feedback and want to
make sure that we are creating these meaningful events that are going to help you
be successful in your applications. With that, I’d like to introduce Lili Portilla,
who is the director of the SBIR/STTR programs and oversees strategic alliances here at NCATS. Lili, thank you. [LILI PORTILLA, M.P.A.]
Thanks, Monique. Good afternoon, everyone. I’d like to welcome you to
the NCATS SBIR/STTR webinar. NCATS is one of 27 Institutes and Centers
here at the National Institutes of Health. It’s actually the newest Center. It was formed in late 2011. We conduct and support research on the
science and operation of translational research and finding ways to cut through barriers that
allow treatments to get to patients more quickly. We focus on what is — one of our other goals
is to focus on what is common across various diseases and also addressing potential
barriers in the translational research process. In terms of how we do translational sciences
here at NCATS, we see this as a field of investigation that’s focused on understanding the scientific
and operational principles underlying each step of the translational process. You will get a sense of what we fund under
the program once I go through the presentation and give you an idea of the types of topics
that we focus on, but also other small business resources that we have here at NCATS. I will do a very quick funding
overview on the SBIR and STTR program. This is one of the largest sources of
early-stage capital funding in the United States. NIH as a whole has one of the largest
programs amongst the federal agencies, and it does allow for U.S.-owned and operated small
businesses to engage in R&D that has a strong potential for commercialization. If you’re used to programs at the NIH like
the investigator-initiated R01 program, this is a different type of grant mechanism that
again has an eye towards commercialization. We have various solicitations here at
the NIH for the SBIR and STTR program. I think the most popular one is the omnibus
solicitation, which has standard deadlines of September and the upcoming January 5 deadline. There is also an April 5 deadline, but that
will be covered under a new omnibus solicitation that will be out on the street come January of 2018. These are investigator-initiated grants —
grant funding, but I will say that if you look at the solicitation, you will get a sense of
the types of topics that each of the 27 NIH Institutes and sister agencies
within the FDA and CDC fund. We also have targeted solicitations as well. It’s always good to go on the NIH website
to see what other targeted solicitations exist. We have one here at NCATS
that I will be talking about as well. Once a year, at the NIH, there is an SBIR
contract solicitation that actually just closed in October. Typically that solicitation goes out
in the August timeframe of every year. Again, not all Institutes participate in the
contract solicitation, but if you go to the current website and pull this up, you can
get a sense of the types of topics that are funded across the NIH. So what is the SBIR and STTR program? SBIR supports early-stage research —
R&D projects at small businesses. The STTR program helps small businesses
formally collaborate with research institutions during Phase I and Phase II of the program. I want to clarify that when I say Phase I
and Phase II, I don’t mean clinical trial Phase I and Phase II, I mean Phase I of
SBIR and Phase II of STTR, which I’ll tell you about in a minute, what those are. SBIR and STTR programs — again, I’m going
to speak from the perspective of NCATS; our mission is to transform translational science
processes so that new treatments and cures can be delivered to patients more efficiently. Our three main areas of interest are within
drug discovery and development tools, biomedical and clinical health research informatics, and
clinical dissemination and implementation research. I’ll also add clinical research management tools as well. Again, I’ll show you what those are in a few minutes. So, SBIR and STTR are congressionally mandated
programs, and they are set aside, which means that federal agencies must set aside a
particular amount of their budget to provide funding for small businesses. This is 3.2 of set-aside of the
NIH budget for the SBIR program. And for the STTR, it’s 0.45 percent. So Phase I — usually when we use the
term for SBIR and STTR, it’s for feasibility studies. The budget guidelines for SBIR and STTR are $150,000. However, the NIH does have a
hard cap that can go up to $225,000. I will say that the best way to find out about
budgets is to look at the omnibus solicitations so you can see what each
Institute will pay in this program. But — I can speak for NCATS — we will
support programs that go up to $225,000 and sometimes more, depending on
what topic areas they are in for Phase I. For Phase II, the budget guidelines are
$1 million, but again, NIH typically goes up to $1.5 million over a two-year period of time. There is a mechanism called the fast track,
which combines Phase I and Phase II, so when you apply, you’re applying not only for
the Phase I funding but for the Phase II funding. Contingent upon you meeting the Phase I
goals, you will get the funding for the Phase II part of the grant. We also have a program that’s on a bit of
a hiatus right now, which is the Phase II — no, I’m sorry, excuse me — Phase IIB
is something that we do fund currently right now. Not all Institutes participate in the Phase
IIB program, but NCATS does, with the caveat that we must have funded your Phase II grant. And it’s additional funding, but it’s
very dependent on our budget and also what it is that you want to accomplish under the Phase II. The best advice I can give for anybody who
wishes to apply to us under a Phase IIB is to make sure you had a Phase II award
with us, but also talk to us before you submit that award to make sure that we
can and are interested in funding it. The last part is the Phase III,
which is the commercialization. If you go to agencies like the DoD, this is
the part where they are basically buying the product that you commercialized. But here at NIH, we’re not typically the customer. This is where we would consider the small
business should think about what partnering and additional funding and exit strategy they
would have to graduate from the SBIR/STTR program. Again, to give you a sense of what the
budget — the overall NIH budget — is about — and this is, I believe, FY 2017 numbers —
the official NIH budget was $33 billion. Almost $1 billion of that was set aside and
mandated to be used for the SBIR and STTR programs. As you can see, that’s a significant amount
of money that is set aside for the advancement of entrepreneurial ideas through
companies that are funded by SBIR and STTR. So who is eligible for SBIR funding? U.S. businesses must be formed here and
managed out of the U.S. with 500 or fewer employees. The principal investigator’s primary
employment needs to be with the small business at the time of the award and during
the entire duration of the project. So, the company must be more than 50
percent U.S. owned by individuals and independently operated, or more than 50 percent owned
and controlled by other business concerns that are 50 percent owned and controlled by one
or more individuals or more than 50 percent owned by multiple venture capital operating
companies, hedge funds, private equity firms, or any combination of these. These criteria for eligibility are given to
us by the Small Business Administration, so these across all federal agencies would
be what constitutes eligibility for the SBIR program. For STTR funding, an established cooperative
research and development effort needs to be delineated, which means you have to be
formally collaborating with a research institution within the U.S. Forty percent of the work
can be done within the small business concern. A minimum of 30 percent is to be done by the
university or nonprofit research organization or what is also referred to as an FFRDC,
which is a federally funded R&D center. Some of these exist throughout the country. Then, you must have a formalized intellectual
property agreement that demonstrates to us that you have the ability to use the IP that
you need to use for the project, meaning if you’re using IP that was developed at the
university, we must know that, at the time of award, there is a formalized agreement
between the small business concern and the university. And the primary employment of the
principal investigator, unlike the SBIR, can be either with the company or with the research institution. So I think one of the benefits of SBIR and
STTR funding is that it is one of the largest funding sources of early-stage
life sciences in the country. I will say that this program, on the
whole, has bipartisan support in Congress. I can’t think of too many things that have
that these days, but this particular program does. It’s pretty stable and predictable from
the perspective that you have an idea of how much is set aside based on
the agency’s budget for that year. IP rights are retained by the small business. It’s not a loan, and it’s non-dilutive
capital for the small business concerns. And I think one of the things that we keep
hearing from our grantees is that since projects undergo this rigorous NIH peer review
process, it seems that our companies have used that as a way of attracting further funding and
collaborations, because they have gotten the scientific checkmark from the NIH talking
about their particular project that has gone through this very rigorous peer review process. So, again, this chart is really good at understanding
what the difference is between SBIR and STTR. Regarding partnering requirements, SBIR, you
can absolutely partner with the research institution, but the STTR requires that you partner with
a nonprofit research institution, university, or college. Work requirements, you can outsource up to
33 percent of a Phase I and up to 50 percent of a Phase II under SBIR. For an STTR, the minimum that you can
outsource is 40 percent for the small business and 30 percent for the research institution partner. And the PI must — has to have primary employment
under an SBIR with the company, but with the STTR, they can either be employed by the
research institution or the small business. But keep in mind, the award
is always made to the small business. So again, these are the funding announcement
numbers for the current omnibus solicitation for SBIR and STTR. The next due date is January 5. I would advise you, once you click onto the
funding announcement, that you can read the program description and research topics guide
to get a sense of what the various Institutes at the NIH are looking for. NCATS topics are there, and also, you can
get a sense of the funding limits for various grants for the SBIR and STTR that each Institute has. All this information is made available in
that link within the funding announcement. Talking very briefly about review, as I said,
a critical part of the application process, aside from putting the application together,
is going through the scientific peer review that we have here at the NIH. What does the score consist of? It’s these five critical points which have
to do with significance; what problem are you trying to solve? What is the commercial potential of the technology? The second is the investigators and the team
you have formed to get the research done. Do they have the right type of expertise and
credentials to get the project off the ground and moving through the entire term of the grant? What is the innovation? Is it new, cutting-edge technology, or is
it improvement on what the current practice is? What your approach will be in
the research design and feasibility. And also, we need to know about the environment. What facilities and resources are you going
to be utilizing to get the specific aims of the grant accomplished? The following — human subjects protection,
animal use, biohazards, and inclusion of women and minorities are not scored individually,
but they will be looked at within the context of the review. So again, just to give you an idea of what
the timelines are here, let’s use the example of submitting an application on
January 5, which is the upcoming deadline. You would expect review, the scientific peer
review, to happen between the February and March timeframe. Then these applications must go through
individual NIH Institute counsel review, which will meet during the May and June timeline. And then, an award date, at the earliest that
we could be making would be sometime in July. And that’s if you — again — this is
the timeline it would follow if you were to submit in January. To give you an idea that we’re talking about
anywhere from six to eight months in making an award for the program. So, sometimes applicants come to us and they
want to get a quick award because they need to get through some kind of important
milestone, critical milestone in their research. I would say that SBIR/STTR is not that type
of program where you can get quick turnaround and get a decision made within a few months. It’s not that type of program. I think, again, the timelines at NIH range
anywhere between six and eight months, but keep in mind the benefits that you’re
getting from the program, which is the validation of your science through the scientific
peer review and the non-dilutive capital. All those pluses that I mentioned. I want to talk about some tips in terms of applying. One of the critical ones, which you’d be
surprised, is sometimes when we talk to applicants, they haven’t even read or looked at the
particular funding announcement that they would potentially be applying under. I think it’s really — my advice is to
get to know your funding announcement really well. Understand what the due dates are, what
the review criteria is, but more importantly, what the funding announcement is covering. Make sure that it’s focusing and aligning with that. Here at NCATS, we wanted to make sure
that it aligns with our areas of interest. If you want to see a sample application that
scored really well, our colleagues at NIAID, which is one of our sister Institutes here
at the NIH, have made a couple of applications available to the public, so you can click
on this link and look and see what a successful application looks like. Also, one thing that people may not realize
is that all funded NIH applications, whether they be SBIR or any other program across the
agency, you can sort through them using this database called NIH RePORTER. My advice to first-time applicants is to get
to know what NIH has already funded in the particular area that you have an interest
in, so you can use this database, put in search criteria, and get a sense of — for instance
— what NCATS has funded in the past, the types of applications. This is to help you find the right home and
get an idea of what currently is in the pipeline at NIH getting funded in the SBIR/STTR programs. The other thing I’d like to say is make
sure that you talk to your NIH Program Officer before you submit an application. It’s very important to get a sense of, number
one, do you fit with that particular Institute or Center that you’re applying to. I know that this is something that here at
NCATS we want to make sure that your application or project would be a good fit for us. And certainly, do it at least
a month before the due date. Things get kind of crazy here, and across
the NIH, I will say, a couple weeks before the application deadlines; you’d be surprised
how many applicants wait till the very last minute to try to have a conversation like this. Unfortunately, we cannot get to everybody. The sooner you have these conversations
with your Program Officer, the better off you will be. Speaking for NCATS, when you would like to
share what it is you’re going to be doing, in order to make our conversation time more
effective, we also ask for a nonconfidential abstract. Or if you want to share a draft Specific
Aims page with us, we’d love to look at that before we have a conversation again, to help
us guide you to make sure that it’s a good fit, that your idea is a good fit for NCATS. If it’s not, we will guide you to the
proper Institute that would be a good fit. One other thing we’d like to say is to make
sure you register early for all the SBIR/STTR electronic submission processes. Several registrations need to happen. Some of those registrations can take
up to eight weeks to get completed. Again, make sure that you do this early on in the
process so that you can submit a good application. Make sure that when you convert your
application to a PDF that the pagination doesn’t get messed up, because applications will get kicked
out of the system if they go over the certain page limit. One of the best tools that NIH has for folks
applying to the SBIR/STTR is the NIH ASSIST program. It walks you through the application process. I encourage everyone — and more
importantly, first-time applicants — to use this when submitting an application to the
SBIR/STTR program at the NIH. You can also specify what Institute and study
section you would like to have your application as a primary assignment, but also which
study section you would like to potentially review the application. All the study sections are actually on
the Center for Scientific Review website. You can look that up and you can see all
the various study sections and what types of applications they review. This can be done as part of your application
process in making these suggestions as to where you want your application to go. I can’t stress this enough: Submit early. Make sure you allow yourself enough time
to put your application together and get all your registrations done before
you submit your application. I think the purpose of this slide is to basically
tell you what we see as the common application problems across the NIH that may lead to
the application not getting a good score or not getting scored. One is that the reviewers don’t see any
significance or that you didn’t do a convincing case in expressing what the impact of that
technology was, what the commercialization potential is. Also, we see that some applications
inadequately defined what they were going to test in the feasibility under the Phase I. The lack of innovation, research
plans that go in various directions. Reviewers like to see focus around the research plan. And also, research that’s commensurate with
the budget limits that NIH has for this program. Also, failure to consider potential pitfalls
and alternatives regarding the technology. Being unfamiliar with relevant
published work that’s already out there. Do a PubMed search and go on that NIH
RePORTER database that I told you about so you get a sense of what’s already out there
and what’s currently being funded. This one is important: unrealistically large
amounts of work being proposed under the grant. We see this in the desire of some applicants
to basically show that they want to get the work done, they overdo what they are
going to be doing in their research plan. Then it’s not commensurate with the
budget of the grant, and this will get flagged by review. So, other important facts to remember. Eligibility is determined at the time of award. So, if your intellectual property agreement
that we talked about for an STTR doesn’t need to be done at the time you submit
your application, but certainly at the time of award, we would want to make sure that the
intellectual property agreement has been executed and everything is fine there. Another thing around the time of award is
to make sure that — we will recheck eligibility of the company to make sure they are eligible
to receive SBIR and STTR at the time of the award as well too. The PI is not required to have an M.D./Ph.D.,
but we will be looking at the team you’ve assembled to make sure that they
can meet the specific aims of the grant. So if you are planning on doing some kind
of clinical research or animal study, that you have the proper team
assembled to get those studies done. Applications can be submitted to various
agencies for similar — can be submitted to different agencies for similar work to
support different aims and objectives. What we don’t want to see is overlap. We want to see very distinct, specific aims,
but they can be for the same technology, just covering different phases of development. An award may not be accepted from
different agencies for duplicative projects. After review, this happens a lot too. A lot of our applicants get a bit discouraged
after they go through the review process only to find out that they did not get a very
competitive score or that they were not reviewed by the review group. That does happen sometimes. But I can’t stress enough that the summary
statement that you get, every application for the SBIR/STTR program will get a written
summary statement with the reviewer’s comments. That is possibly one of the most helpful
guides to getting you to resubmit your application. It’s a roadmap on how to improve the
application, based on what the reviewer’s feelings were on those five criteria that I mentioned. Please be open to these reviewers’ remarks. I know that sometimes it can be somewhat
personal to hear something that somebody doesn’t think is a great idea, because it is your
idea, but I can’t stress enough that the summary statement is a great
roadmap for improving your application. If you want to get a sense or a better understanding
of what the process and the dynamics are of the NIH peer review system, go to the
Center for Scientific Review, which is the link we have here, to learn more about what the process
entails, how study sessions are put together. Again, I can’t stress this enough. Spend time reading and revising your aims page
based on what you get from that summary statement. I wanted to tell you that we talked about
the various registrations that you’re going to be needing to get your application submitted. There are five separate
registrations that need to happen. You can go to this link to learn more, but
the message here is to allow yourself a fair amount of time. As I said, some of these
registrations can take eight to six weeks. And one registration is dependent on the other one. So make sure that you follow the directions
and the order in getting these done so that by the time you submit your application,
you don’t get any errors around the fact that you don’t have the proper registrations in place. I wanted to talk about one of our
companies that we funded in the past. This is AiCure. It’s a company out of New York. They were addressing the
problem of medication adherence. This is a problem that is seen within
folks who participate in clinical trials. AiCure came up with an artificial intelligence
that would visually confirm that the patient was ingesting the medication. This clinically validated platform
works on smartphones and tablets. It makes sure that patients are adhering to
taking their medications once they’re participating in a clinical trial. So AiCure received two SBIR awards from us,
and they were able to leverage those awards and attract additional funding in $12
million from venture capital investors. They also established several strategic partnerships
with various pharmaceutical companies who had an interest in making sure that patients
were adhering to taking medication under clinical trials. So they were sponsoring — if you can
imagine, the whole enterprise of putting a clinical trial together and making sure people are taking
their medications is quite an expensive undertaking. And the pharma companies that participated
and are now clients of AiCure thought that this technology really addressed a significant
bottleneck that was out there, making sure that patients who participate in clinical
trials are adhering to taking their medication and that this can be monitored by
the person running the clinical trial. I’m going to segue now to additional small
business resources that we have here at NCATS. Before I do that, I wanted to mention that
there are several entrepreneurial courses that are available to Phase I awardees at the NIH. One of them is the CAP program and the Niche
Assessment Program, which you can learn about by going to the NIH website. We also have one called I-Corps,
which is geared toward Phase I grantees. They can participate in the training. What NIH does is give you basically a
supplement to the grant to participate in the training, no cost to you. All you have to do is provide the time and
the energy to participate in the training. There’s also another training with the culture
foundation that focuses on medical devices that a couple of our sister Institutes also participate in. You can learn more about those on the NIH website. NCATS has a couple of de-risking programs
here that we have for small businesses and academics. The first one is the BrIDGs program. In this program, applicants enter when
they have a clinical candidate identified. Any disease is eligible. This is just to get you to an IND filing. If there’s a critical tox study or animal
study that you need to get done, or perhaps you may need GMP-grade material in order
to get a Phase I trial done, to get an IND file, to get a Phase I trial done, we can help by
providing you access to our CROs and internal expertise to get some of these critical studies done. It’s not funding, it’s just access to resources. This program is eligible for SBIR-eligible businesses. If you’re interested, you can learn
more about it by going to our website. The other program that does the same thing is the
Therapeutics for Rare and Neglected Diseases program. This program does focus only on diseases that
meet the FDA orphan designation or WHO neglected tropical disease criteria. This program does take you past
IND and can get you up to a Phase IIA. It’s milestone-driven. Various modalities are taken, and you work
very closely with our project managers and direct development teams here at NCATS to
get access to these resources that we have here. This again is also eligible to small
businesses here in the U.S. but also foreign entities as well because of the neglected
tropical disease aspect of what we fund here, or what we support. I’ll give you a quick example of an applicant
and what they did and how they used a couple of these resources here at
NCATS as well as the SBIR and STTR. This particular applicant was an academic
investigator who had developed this new molecular entity for treatment of a rare disease. She had received a couple of R01 awards in
a couple of STTRs, which totaled about $3.5 million. She went to the FDA and was told that she
needed to get two pre-clinical tox studies done. And she was kind of stuck because these
tox studies were not really typical things that she could get funding for under NIH grant programs. She hit this valley of death that we’ve all heard about. What she ended up doing was applying to the
BrIDGs program, and BrIDGs was able to support these two pre-clinical studies
that were required by the FDA. They totaled about $500,000. Once she did that, she was able to file her
IND, and after that, she was able to raise about $50 million in venture capital Series A funding. So you can see that this program gets you
through this valley of death to get you to hopefully a successful partnership and more
fundraising around your small business. So, with that, I have concluded my presentation. I want to thank everyone for listening. We will entertain questions now. [MONIQUE LAROCQUE]
Thank you, Lili. The first question is, “Can you explain
what the difference is between applying for SBIR and STTR funding at NIH versus NSF?” [LILI PORTILLA]
The process may be a little bit different in terms of the forms that need to be put together. But I think the biggest difference between
the two is the NIH peer review system and the fact that all SBIR and STTRs must go
through that review process and, again, NIH being very much of a life science-focused organization,
the review is going to have that focus around it. As I said, if you’re working in this area
of biomedical research, I think validation from the NIH does help in terms of further
fundraising and development of strategic partnerships with your small business. I would say that the review is
probably the biggest difference. [MONIQUE LAROCQUE]
Thank you. So you mentioned that you encourage
applicants before they actually start working on the application to reach out to the
program director of the Institute. What do you mean by that? What should
they share, and what is permissible to ask? [LILI PORTILLA]
If you can share a nonconfidential abstract on what it is that you would like to propose
to do under your SBIR/STTR grants, that would be great. Some applicants actually come to
us with a draft Specific Aims page. That’s a great way of us making sure that
it’s a good fit for NCATS or any other Institute here at the NIH. Those pieces of information are good conversation
starters to determine whether the application would be a good fit, especially here at NCATS. And I will add that at the time you have
that conversation, if you could start exploring the NIH website and familiarize yourself
with the various funding opportunities there, I think that also helps the conversation too. [MONIQUE LAROCQUE]
Thank you. We are getting questions about
whether the slides will be available. We do want to share that these
slides will be posted on our website. We’ll also be sending out a thank-you
e-mail with the slides and a link as well. The next question is about how to approach
all of the setup and registrations that are needed. Should we build the applications using the
ASSIST program or via grants.gov workspaces? [LILI PORTILLA]
For us, the ASSIST program is the one that we’ve been referring our potential applicants to go to. I’m not that familiar with the
workspaces, but I’ll add that I think if you go to the NIH website, it does give you a guideline
for the order of how to do the submission process. The other thing that’s on the NIH website
that not very many people know of is that there is an annotated application on there
that you can pull and get a sense of what are the required fields and what is the
type of information that we’re looking for. That’s also another really helpful guide. And specific questions around — if you’re
having specific technical questions about submitting, please contact eRA Commons,
because I can’t see how your dashboard looks like in eRA Commons. I don’t have access to it. Our colleagues at eRA Commons are the ones
that you need to troubleshoot with if you’re having any issues. [MONIQUE LAROCQUE]
The next question is about BrIDGs, because you talked about additional
resources available to applicants. Can you describe who is an
appropriate candidate to apply to BrIDGs? What are the typical due dates, and what
are the success rates of applications? [LILI PORTILLA]
BrIDGs is not a grant program. It’s access to resources and expertise. They look at applications in tranches. They just went through closing an application. They had a significant amount of applications,
so they have stopped accepting applications for now. But we expect that to start
back up sometime later in the year. You would be notified of that if you go on the
NCATS website and sign up for our e-mail notifications. Who is a good candidate? That’s a great question. I think the best piece of advice I can give
anybody who’s interested in that program is to have a pre-discussion, just like you
would call me to submit, whether you were going to submit here for an SBIR. Talk to the BrIDGs people about what you have. They will be asking you for some data, what
data you’ve collected thus far, the disease area, and where it is that you see that you
need some assistance to getting you over this valley of death. They will have that
pre-application discussion with you at any time. If you go on the website, you can click the
e-mail there and then set up a time to discuss what you have and see if BrIDGs or TRND
would be good fits for your particular issue. [MONIQUE LAROCQUE]
Thank you. This question is about the deadlines. Are they the same across all NIH ICs? I know that some Centers and Institutes have
specific applications or topics that they want to fund. Can you describe what those universal deadlines
are and then why they may be different deadlines for other opportunities? [LILI PORTILLA]
The omnibus solicitation, which I would say the majority of NIH applications come under,
have standard dates, which are January 5, April 5, and September 5. Some specific funding announcements
will follow those submission dates. But others do not. The best piece of advice I can give you is,
again, look at the funding announcement, look at what the due dates are, because they may
deviate from what the standard omnibus solicitation due dates are. But the omnibus solicitations may shift a
day or two based on a particular holiday coming. I know that when there were weather problems
in Houston, we extended the date for those applicants, but they had to prove
that they were from the Houston area. There is some latitude on the submission
dates, but there has to be a particular reason. Again, look at the funding announcements. If you have any questions, talk to your Program Officer. [MONIQUE LAROCQUE]
Thank you. The next question is easy. “How can we stay in contact with you?” I think we have a slide on that, and we will
bring that up so you can take note of that as we continue talking. The next question is, “Is IP required to
apply for an SBIR or STTR grant?” [LILI PORTILLA]
No, IP is not required to submit an SBIR/STTR grant. However, I will say that, maybe not so
much for a Phase I, but certainly for a Phase II grant, I think reviewers would like to get
a sense of what intellectual property you have or are planning to file on, or
what you have filed on thus far. By that time, during a Phase II grant, you
must also include a commercialization plan. As part of that commercialization plan, you
will be asked to talk about your technology and what intellectual property
you have protected thus far. [MONIQUE LAROCQUE]
Next question. “Can you apply for an SBIR Phase 1 and subsequently apply for STTR Phase II?” [LILI PORTILLA]
Yes, you can do that. That is possible, to switch from
SBIR to STTR and vice versa. [MONIQUE LAROCQUE]
“Is there a limit on how many SBIR/STTR applications and applicants submit per cycle?” [LILI PORTILLA]
There is some guidance on that on the NIH website. The issue comes in more
when these grants are awarded. There is a limitation on the amount that you
can have awarded from a particular agency. There is guidance on that from the NIH website. So, could you submit multiple
grants in an awards cycle? Yes, as long as they are separate and
distinct aims that you’re trying to cover. That there’s no overlap, because we will
and do have the ability to look across the various Institutes here at the NIH and also
agencies to make sure that there’s no overlap in applications. [MONIQUE LAROCQUE]
You mentioned being able to submit to multiple Centers for the same technology platform as
long as they’re different aims geared towards the objective of the Center. In that case, can the description of the underlying
technology be used in all the applications? [LILI PORTILLA]
Yeah, but again, what the people are going to be really focusing and concentrating on
are the specific aims of the application, what it is that you’re proposing to do and
making sure that those aims don’t overlap with another application. [MONIQUE LAROCQUE]
I think following this train of thought, some folks have asked, “If you submit to one
IC and they decide it may not be a perfect fit for the Institute, do you all share among
each other, you know, the application?” [LILI PORTILLA]
That’s a really good question. There is a primary assignment made for the application. As an example, you speak to me and we find
out that your application is a great fit for NCATS. I’m going to ask you to make sure that in
your application you say that you want NCATS as a primary Institute. What you can also do is also mention
secondary assignments, so if your application has a bit of an oncology focus, you could also list
NCI, the National Cancer Institute, as your secondary assignment. So what happens in those instances? Well, sometimes if another Institute is
willing to fund the application and NCATS isn’t, we can transfer the application and we can
transfer it to one of the folks that are listed as a secondary assignment. Or the other thing that sometimes happens
is that that secondary Institute will help co-fund the application with the primary Institute. There is a lot of that that
happens within the NIH as well too. [MONIQUE LAROCQUE]
We’re still receiving multiple questions. I did want to pause just to acknowledge
our partners. We’ll go to the next slide. Just so you have an understanding
of their contact information as well. So the next question that I’m getting as
we move through the priorities and refresh on that, but they are saying that they don’t
seem to include — medical devices and focus on drug discovery and commercialization. Are there medical devices
supported by the STTR mechanism? [LILI PORTILLA]
Yes, there are many Institutes that — I will say that for NCATS in particular, we
don’t focus that much on devices, but there are many Institutes at the NIH that have particular high
incidence of devices that they fund under the program. Cardiovascular type devices are funded under
the National Heart, Lung, and Blood Institute, for example. If you have bioimaging or a bioengineering
type technology, you can also talk to the NIBIB, which is the National Institute of
Biomedical Imaging and Biomaterials, I think. I’m sorry if I’m getting that wrong
but I’m pretty sure that’s what it is. Again, check out the omnibus solicitation. Go to that program description guide that
I talked to you guys about, and look there, because I’m pretty sure that if there’s
an idea in this space, it’s listed in that guide. And you can find out who
would be interested in funding it. [MONIQUE LAROCQUE]
Thank you. “Where can we find the program
director’s contact information?” I do think that we talked a little bit about
that, and I want to make sure that you know that you can e-mail [email protected] There are real people who answer those
e-mails, and they do so in a timely manner. Please plan ahead before the holidays, because
sometimes they get a rush during the holiday season to get those deadlines met. [LILI PORTILLA]
Yeah, and, Monique, I’ll add that in the omnibus solicitation that I just mentioned,
if you go to that solicitation, it lists not only me representing NCATS, but all of the
other 27 Institutes and FDA and CDC representatives as well, and their contact information. [MONIQUE LAROCQUE]
Thank you. Can you review the deadlines for the omnibus solicitation? There’s some confusion as to whether you
must submit by January and April as only a chance for resubmission. Can you talk through those deadlines again? [LILI PORTILLA]
Sure. So these are — January 5, April 5, and September 5 are separate
and distinct submission dates. If you end up submitting the application
due date, the next one is January 5, 5:00 PM, your local time, that you have to have
the application submitted to the NIH. If, for some reason, you don’t score well
and you wish to resubmit, you can do that; you will have the information to do
that for the April submission date. If you go to the NIH website, there are some
very helpful FAQs there that talk about the NIH resubmission process, the
term for resubmitting an application. There must be something like 50 or more FAQs
listed on there. That’s another great resource that we have
available to applicants that pretty much answers every question I think think that
I’ve come across in the program. [MONIQUE LAROCQUE]
Thank you. I know that NCATS, in the
past, has targeted solicitations. Typically, when are those announced? [LILI PORTILLA]
The targeted solicitations — it would be great if you could sign up for our listserv, because
then you would be notified as to when they’re released. But you can also go to our website under Small
Business Resources and go to the funding page. You can get a sense of the different individual
funding announcements that we participate in and are leading. NCATS currently has one that we are leading,
which is Tools and Technologies around Nucleic Acid. And that’s listed on the page, so if you
go to the website, you can pull that up. Those due dates are actually consistent with
the standard omnibus solicitation that I talked about. [MONIQUE LAROCQUE]
Thank you. Can you please discuss a little bit more about
the fast track and a company who is ready to go straight to fast track? And what would reviewers be
looking for in those types of applicants? [LILI PORTILLA]
A fast track application, again, is one that combines the Phase I and Phase II. There is some expectation that you have some
preliminary data to apply to the program. I would say that the review bar is a bit higher
than just going for a straight Phase I application, because we’re making a commitment to not
only fund the Phase I but the Phase II. So some data will be required and again, we
will give you the Phase II funding only after you’ve completed all the specific
aims that you’ve stated in Phase I. So, there was a mechanism that the NIH
had that currently is not available it may be in the very near future, as soon as Congress
re-authorizes this authority which gave companies the ability to actually skip the Phase I
and go directly to a Phase II; it’s called a Direct-to-Phase II. That’s another program that we’re
hoping will get re-authorized. We’re hoping that’s going to happen
sometime in 2018, fingers crossed. When it does, we will let the public know. That will be another way of engaging with the program. It’s a good way, if you have a lot of preliminary
data that would allow you to skip that Phase I and go directly into Phase II. That’s probably the best program
but, like I said, it’s not available yet. Fingers crossed that it will be in 2018. [MONIQUE LAROCQUE]
Thank you Lili. One last question. This relates to being able to switch Institutes. “If you apply for a Phase I at one Institute,
can you apply for a Phase II elsewhere?” [LILI PORTILLA]
You can, but I really encourage you to talk to the Program Officers and not just the Institute
that you want to go to but the one that you currently have your application. That happens — it happens, and there has
to be a good reason why. Maybe it wasn’t a very good fit or maybe
you’re actually going in a bit of a different direction that is more
consistent with the other Institute. So, before you do that and make that request,
make sure you talk to both Program Officers from the current Institute where your application
was submitted to but also the one that you want to go to to make sure that it’s a good fit. [MONIQUE LAROCQUE]
Thank you. We want to thank you for your time. We also want to thank our partners again. Thank you to Life Science Washington, New
Mexico Biotechnology and Biomedical Association, the Oregon Bioscience Association,
Bioscience Association of North Dakota, and Montana Bioscience Alliance. You can see some of those contacts there. Please also take a few minutes
to fill out the feedback form. If we haven’t answered your question and
you want to talk more specifics about your project, please do e-mail us at our NCATS e-mail. Thank you for your time.

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