Increasing Diversity in NIH Small Business Programs

February 5, 2019

David Kosub: �� Hello and welcome to another edition of NIH�s All About Grants podcast.� I�m your host, David Kosub, with the NIH�s Office of Extramural Research.� The key to NIH�s long term success is promoting a strong and diverse biomedical research workforce.� With different life experiences, after all, come a wide array of perspectives and creative solutions that are used to address some of the most complex medical issues.� But we recognize, however, that some groups remain underrepresented in the scientific enterprise.� This is definitely true for entrepreneurial small business innovators too.� Thus, if we can foster participation from different researchers in the biomedical commercial space, then we should be able to stimulate new technological innovations, as well as advance our public health mission.� And that�s what brings us here today.� We have with us Dr. Kory Hallett.� She is a Program Director with the National Cancer Institute.� And Ms. Stephanie Fertig who�s a Director of Small Business Programs at the National Institute of Neurological Disorders and Stroke.� And they will be talking about some of the ways that NIH is encouraging applications from small businesses led by underrepresented groups, just another step that we�re using to diversify the Small Business Innovation Research, SBIR, and Small Business Technology Transfer Research, STTR, programs.� Thank you both for being with us.

Kory Hallett:�� Thank you.

Stephanie Fertig:�� Thanks for having us.

David Kosub:�� So, Kory, I�d like to start with you first.� Can you briefly describe the NIH�s Small Business Programs in general and get us all on the same page?

Kory Hallett:�� Sure, so the SBIR and STTR programs at the NIH, these are congressionally mandated programs that set out to provide early stage funding for small businesses that are developing innovative technologies.� The program is available to small businesses through 23 of the NIH Institutes.� And that includes NCI and NINDS.� We�ve funded several companies when they were starting out that have gone on to become pretty successful.� So the congressional mandate has four goals that are stated for the SBIR program.� And that is to stimulate technological innovation, to meet federal research and development needs, to increase private sector commercialization of innovations that are derived from research out of the federal funding, and to foster and encourage participation in innovation by entrepreneurs that are women or socially and economically disadvantaged persons.

David Kosub:�� And, Stephanie, actually building on what Kory just ended with, can you talk a bit more about the steps NIH is using to diversify our Small Business Programs?

Stephanie Fertig:�� Sure.� So, NIH recently released a diversity supplement specifically for SBIR and STTR awardees.� And this builds on the existing NIH diversity supplement for multiple mechanisms that we already have.� But this provides support for, not only research experiences, but also entrepreneurial experiences for those individuals who are generally underrepresented in small business.� And our hope is to really increase the number of women and individuals from socially and economically disadvantaged groups on SBIR awards, improving the overall diversity of the workforce.� And then hopefully some of these individuals will catch the entrepreneurial bug and may start companies of their own.

David Kosub:�� So you all both mentioned women-owned and socially and economically disadvantaged groups.� Can you talk more about these and the outreach to them?� Like who qualifies, for example?

Kory Hallett:�� Sure.� So women-owned businesses and socially and economically disadvantaged businesses that are applying to the SBIR program still must meet the federal definition of a small business, which is 500 or fewer employees.� And there are pretty strict federal definitions of women-owned, which is 51 percent or more of the ownership of the company must be by a woman or women.� And, additionally, socially and economically disadvantaged businesses have a federal definition that is somewhat confusing.� So I don�t want to give people the impression that it should be obvious when they read through the definition.� But, in general, 51 percent or more of the company must be owned and controlled by one or more persons that qualify as socially and economically disadvantage.� And ultimately this determination is made by the Small Business Administration.� This is a self-certification.� So, on the application when the application goes into the �SAM� or System for Award Management, this is a checkbox on the application that the applicant would self-certify as woman-owned or socially and economically disadvantaged.� And one question that people frequently ask is if women-owned and socially and economically disadvantaged businesses have a priority in peer review.� And the short answer to that is �no.�� But we are trying to increase participation in the SBIR and STTR program by these businesses.� We�ve been conducting a lot of outreach.� So we conduct outreach through conferences, through specific targeted events in different regions.� Also we participate in the Small Business Administration�s Road Tour, that talks about the SBIR and STTR programs.� And NIH is currently exploring best practices to make sure that we are reaching all entrepreneurs and scientists that are interested in the SBIR and STTR program.

David Kosub:�� Great.� So now let�s jump to the application process.� Can we all speak to some tips that our community might find of interest to help strengthen their application, perhaps deciphering the application instructions they see in funding announcements, things like that?

Stephanie Fertig:�� Sure.� So while the application page limits are short, these are technical reviews, so applicants have to put in enough detail in their application so that the reviewers can get as complete a mental picture as possible of the product that they�re trying to develop.� And that includes clear �go/no go� milestones between that feasibility study in the Phase 1 and the further research and development that happens in the Phase 2.� In addition, they should put a couple of sentences in there about where they plan to go after the grant is done, what those next steps are.� Now, that can seem like a lot and so I really encourage people to look at some of the sample applications that we have on the SBIR Small Business website under the �Resources� section.� And that can help them get a better idea of some of the things that people normally put in their application and how much detail to go into.

David Kosub:�� Well, going beyond just looking at the website, would you recommend any other things that someone should be doing behind the scenes when they�re putting together their application?

Stephanie Fertig:�� Absolutely.� Grantsmanship is really very different from developing an investor pitch that might be more high level or more focused on the finances.� So, since grant writing is a very different skill and can take a lot of time, it really helps if you have somebody read the application who�s outside of your company or not one of your collaborators; someone who�s looking at it with a fresh pair of eyes.� If you have somebody like that in your network, that�s great.� And I would certainly take advantage of that individual.� But you can also go to NIH RePORTER and see the individuals who have successfully competed for an SBIR or STTR application in your geographic area, and�or even in your city, and�reach out to them.� I�m often surprised how much other small businesses are willing to help new applicants to the program.� And then, also, contact your program officer.� I mean, if you take nothing else from the podcast today, contact your program officer.� Each institute and center is a little bit different.� And, really, your program officer can help talk you through the different budget guidelines, what programs might be specifically available to your company and really help provide guidance as you go through the process.

David Kosub:�� So, sticking with the NIH side, I�m sure that you�ve seen some common errors in the application process from some applicants, are there any programs that may be available to help someone put together their application from our side?

Kory Hallett:�� So our institutes, NCI and NINDS, in collaboration with NHLBI last year, participated in a pilot program, the Applicant Assistance Program.� And this program was open to all small businesses that were eligible for the SBIR and STTR program that had not previously received an NIH SBIR or STTR award.� So, any small business that was preparing their first application, or had submitted previously and was unsuccessful, was eligible for this program.� And the AAP was designed to provide assistance to small businesses with a great technology but limited understanding of the NIH application process.� So we understand that some underrepresented groups, so women-owned businesses and socially and economically disadvantaged businesses and some companies that are in underrepresented geographic regions�and so what I mean by that is geographic regions that don�t receive a lot of NIH funding, that they�may not have a very good network to help them prepare their application.� And so the Applicant Assistance Program provided coaching for these small businesses as they moved through the application process, gave them feedback on their proposal, and helped them to understand what needed to be done at what time point, marching up to the submission deadline.

David Kosub:�� So let�s go on further, past that application deadline, and move into the peer review process.� It was briefly mentioned that there�s no special considerations given to these groups in the peer review process, but perhaps one of you all can speak to the seeing behind the curtain, what�s going on in those study sections, how are they looking at your applications, reviewing the merits behind the proposed research, and then, how is that built into the overall impact score.

Stephanie Fertig:�� So these reviews are very similar to other NIH reviews, for, say, the R01 or other mechanisms.� There are three or more assigned reviewers and these reviewers give some preliminary scores.� And about 50 percent of the applications that are the best scoring applications are discussed.� But all applicants get feedback from review, regardless if they�re scored or not scored, from those assigned reviewers.� The difference is, between SBIR and STTR programs, is that it�s really about developing a product and not hypothesis driven research.� And so, in addition to the researchers and individuals who really understand how to develop a product or a technology, we also include people who have had experience with businesses and developing a business.� And we include clinicians or other users of the product.� And they�re all part of that review.� And so they�re thinking, not just about the technology, but about adoption and integration into the existing workflow.� And so the reviewer really has to believe that it will be adopted into practice.� And so you need to put it in the context of the market as a whole, talk about the product in the context of different solutions that are currently available and out there, as well as what�s been tried and failed.� Some of the worst things that can happen to a product in review is if it�s a really cool technology, everybody is excited about it, but the clinician or the potential user of the technology raises their hand and says, �This is great but how is this different from this other product?� or �I don�t think I�m ever going to use this.�

David Kosub:�� All right.� So we�ve gone through the application development, we�ve submitted the application, it�s gone through peer review; now what?� What should an applicant be thinking about after their application has been scored and if it was awarded what should they be thinking about regarding compliance?� And then, alternatively, what should they do if they didn�t get scored well and didn�t get an award?

Kory Hallett:�� Yeah, post review is a really important time for your application.� And so what will happen is after a peer review a couple of days later you�ll receive a score.� And then several weeks after that you�ll receive a summary statement, which is, if your application was scored, there will be a high level description of that discussion in the room.� And, in either case, whether the application was scored or un-scored, each of the three primary reviewers will give comments on your application in your summary statement.� And this is a really good time to contact your program officer and debrief, talk to them about the comments in the summary statement and talk about the next steps.� Program officers read a lot of summary statements and sometimes have a better idea of what factors were score-driving and what weren�t.� Or they see sort of repetitive concerns by peer reviewers in certain states and can give some advice on how to handle that.� At the top of the summary statement will be a program officer�s name and contact information.� And I encourage people to use that.� I prefer that people email me.� I think many program officers do.� But I think the summary statement provides both the phone number and the email.� Now, if a company is funded, I encourage them to look at the many programs and initiatives that are offered to them through the SBIR and STTR programs at NIH.� There are some programs that are somewhat institute specific but several programs that are NIH wide.� And these programs are really designed to help people mature and grow their small businesses.

David Kosub:�� That actually provides a great transition to understanding more about these programs.� Stephanie, perhaps you could talk a little bit more about these programs that are available to awardees.

Stephanie Fertig:�� Absolutely.� I�m always surprised at the number of individuals who don�t take advantage of the different resources and programs that are available to them.� So for Phase 1 awardees we have entrepreneurial training programs, the I-Corps and the C3i, that provide mentorship and guidance to help people understand the value of the product that they�re developing and to formulate a clear business plan.� We also provide market analysis to Phase 1 applicants that they can use for their Phase 2 proposals.� For the Phase 2s, we have the Commercialization Accelerator Program that helps provide support for better planning and figuring out the activities necessary to commercialize that product.� And that can include regulatory and reimbursement activities as well as how to pitch to investors.� And then, finally, we provide opportunities for companies to pitch to investors at different investor conferences.

David Kosub:�� This has been wonderful advice.� Before we close do you all have any final thoughts you�d like to leave with our listeners?

Kory Hallett:�� I have three quick final thoughts or tips for listeners.� One is to become familiar with where to look up information.� We generally don�t have access to information that you don�t have.� The SF424 Application Guide, the Grants Policy Statement, and the funding announcement to which you�re applying, are really critical documents to get to know.� Oftentimes when someone contacts me I end up keyword searching these documents.� And that leads me to the second thing, which is:� Don�t hesitate to contact us.� Even though I just encouraged you to become familiar with these documents, if you can�t find the information you can contact me, because sometimes I know the keyword, I�ve looked it up several times.� The third thing I would say is:� Be prepared to resubmit.� It�s a competitive program and oftentimes a resubmitted or an amended application has a higher chance of success than an original application.� It�s not personal.� It�s just in the original application sometimes peer reviewers have additional questions.� That�s why the resubmission process is in place.� And so be prepared to resubmit to be successful in the SBIR and STTR programs.

David Kosub:�� Wonderful.� This has been a lot of great advice.� I truly appreciate your time, Kory and Stephanie, for sharing your views on increasing diversity in our Small Business Programs.� And, just to reiterate a few other points that were made earlier, please do not hesitate to visit the NIH�s Small Business Grants web pages, SBIR.NIH.gov, where you can find a lot of the information that we talked about today, as well as some more detail on those programs that were referenced.� As well as, if you�re not familiar with exactly which program officers to contact we have a wonderful tool available called the �NIH Matchmaker,� which you can use to help to find an appropriate person or persons here at NIH to talk about your application.� With that, this has been David Kosub with NIH�s All About Grants.� Thank you very much.w