I recently had the privilege of interviewing Dr. Lenka Fedorkova, assistant manager of the National Institutes of Health Small Business Innovation Research and Small Business Technology Transfer programs. Through NIH’s Office of Extramural Programs, Dr. Fedorkova provides guidance and access to critical information for U.S. small businesses seeking NIH funding, among other responsibilities. Learn more about her role and the NIH SBIR/STTR programs below.
Question: What is your current role within the National Institutes of Health SBIR and STTR programs, and how do you typically work with program awardees?
Dr. Fedorkova: At the NIH, the administration for the SBIR and STTR programs is centralized within the Office of Extramural Programs, which is part of the Extramural Research Office within the Office of the NIH Director. Our office fulfills the role of the coordinator of the programs across the 24 institutes and centers (ICs) that have the funding authority and make the actual awards.
Our roles are wide ranging and include:
- development and publishing of all the SBIR/STTR funding opportunity announcements in coordination with the ICs,
- ensuring new and old policies are consistently applied across the NIH components,
- implementation of new legislative changes,
- brokering with all ICs to ensure spending down of our set-aside budget before the end of each fiscal year,
- analysis of award data and official reporting of program results to SBA and Congress, as well as
- officially representing NIH at congressional hearings and other administration proceedings.
As charged by law, our office conducts extensive outreach to all small business communities, thus we present at many national and local entrepreneurial events. Finally, perhaps less known is the fact that we also fund and manage several contracts for NIH-wide programs including the Niche Assessment Program for Phase I awardees and the Commercialization Assistance Program for Phase II awardees, which I manage.
Question: What are some common challenges that you’ve seen among your award recipient clients?
Dr. Fedorkova: Frankly, the majority of the challenges we see tend to occur at the pre-award phase. Because we have such a rigorous vetting process during and post review, once the award is made there are rare cases where truly significant problems can arise that might affect the project. The grants management specialists at each IC are intimately involved with oversight and ensure awardee compliance with all rules and regulations, including appropriate use of funds.
Overall, most challenges are effectively managed when the awardee maintains good communication and seeks timely advice from both the grants specialist and the program manager. For contracts, which make up about 5% of our total awards, the oversight is different, according to the Federal Acquisition Regulations, where project managers typically receive monthly progress reports and monitor deliverables closely.
Question: What is the Niche Assessment Program? When is an appropriate time for a NIH SBIR/STTR awardee to apply for assistance through this program?
Dr. Fedorkova: The Niche is offered annually and available only to current Phase I awardees, so once the project period ends, that awardee is no longer eligible. The main objective of the program is to provide awardees that have the need with market opportunity analysis, which may include feedback from potential customers, early adopters, assessment of barriers to market entry, better understanding of the size of the market, and identification of market segments that may not have been previously considered.
Since the vast majority of our awardees are truly small, meaning less than 10 employees, they don’t have the resources to research their market and customers, so the Niche fills a very important knowledge gap. Many of the participants have also used this information in preparing their commercialization plans when applying for Phase II grants or contracts. More information about Niche is available here.
Question: What is the Commercialization Assistance Program (CAP)? How have you seen Phase II awardees benefit from this program?
Dr. Fedorkova: The CAP is also offered annually and open to current Phase II awardees as well as projects that were completed no more than five years ago. It is a business mentoring and training program that lasts about 9 months, where companies are paired up with industry domain experts and work together on resolving very specific challenges they have encountered along the way to commercialization. The advice and consultations with experts these participating companies receive is highly customized and tailored to their specific needs, level of maturity, and commercialization experience.
Each year the program mentors between 70-80 companies that can participate in one of three specifically designed tracks. The issues we cover in the CAP range from intellectual property, go-to-market strategies, fundraising, developing strategic partnerships and pitches, FDA regulatory and reimbursement strategies, and overall company management and growth strategies.
Since 2004, we have worked with 830 companies. In aggregate, the CAP program helped these companies raise over $586,000,000 in non-governmental funding; sign over 586 deals, 26 acquisitions, and many distribution and licensing agreements; create over 1,680 jobs; and form thousands of strategic partnerships from the vast CAP network of industry experts and advisors.
Companies in the CAP achieved varied levels of impact from deciding on which indication(s) to pursue, if and when to hire a CEO, whether to create a subsidiary, how to price their product, how to differentiate themselves against the competition, and whole host of pivotal decision points. Many of our program successes are past CAP participants featured on our website.
Question: What advice would you have to offer new NIH SBIR/STTR program applicants with patentable ideas who seek to partner with universities and/or industry partners?
Dr. Fedorkova: First, I want to highlight that intellectual property (IP) derived under the SBIR or STTR project by the small business is retained by that company. That means that awardees do not need to fear losing it to the government, which only retains rights to use the technology typically in cases of national emergency and need.
While we cannot provide specific advice on this matter, I can say that doing the extra homework and really understanding the terms of the agreement with any partner is critical. Specifically when partnering with universities, such as seen in STTR projects, it is very important that the small business considers long-term implications of their terms of agreement. Some of these terms may affect their freedom to operate when they move into partnership discussions and licensing negotiations with industry entities only to find out that they do not own the IP.
Our application instructions contain a sample material transfer agreement for those applicants who have perhaps never negotiated such an agreement before and need a place to start.
Question: How can an innovative small business with a new life science-based product/service idea effectively demonstrate a strong plan for reaching commercial market, given the limited page count budget for this discussion in NIH SBIR/STTR Phase I proposals?
Dr. Fedorkova: Due to the investigator-initiated funding model we have at NIH, a large number of the proposals are disruptive technologies with untested markets or very crowded and well-established competition. Either way, the best way to express to reviewers how innovative and commercially viable the project is to take a big-picture, top-down approach.
Be able to express in very few words what market need or problem the technology is solving and then elaborate with key supporting research, knowledge of established practices, and differentiation from these established practices. Applicants need to be able to articulate the value added to the research or clinical field and to target customers and markets.
The page limits are intended to draw out the most essential elements of how the team of principal investigators has thought about moving the technology through the various development stages.
NIH reviewers want to see that applicants have realistically gauged how much investment or types of collaborations and other support would be needed to eventually make the technology market ready. Writing succinctly takes time and practice, just like a one-page executive summary or a one-sentence value proposition.
Question: Based on your experience, what components need to be fully expressed within the proposal to prove to the NIH that the project team has the skills necessary to conduct the proposed work?
Dr. Fedorkova: When it comes to evaluating the team, it is important to keep in mind that NIH applications are multi-PI applications. Applicants should take advantage of this and assemble the strongest team of experts that on the whole will demonstrate to reviewers that the required core expertise from the specific scientific field is present, as well as management skills, to ensure that the project will move forward toward achieving proposed milestones.
The team provides biographical sketches, letters of support and commitment from key collaborators, descriptions of roles of each team member, and especially a clear research plan that outlines in detail what approach the team proposes to pursue to conduct its studies.
Question: Any other tips you’d like to share with the life science entrepreneurial community?
Dr. Fedorkova: An important note – the new NIH SBIR/STTR Omnibus funding opportunity announcement will be released in early June with new standard submission deadline dates of September 5, January 5, and April 5 applicable to both non-AIDS and AIDS-related grant proposals.
Small businesses can sign up for our SBIR Listserv for latest policy changes and updates, as well as receive the weekly NIH Guide for Grants and Contracts for weekly listing of new funding opportunities. Additional helpful resources are available on the NIH SBIR/STTR site.
