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Since the last time I’ve written about our small business research programs, there have been a lot of important changes as a result of the Congressional reauthorization that mandated Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding requirements through fiscal year 2017. The reauthorization includes changes that are intended to strengthen the SBIR and STTR programs’ outreach strategy, reporting mechanisms and small business eligibility requirements. We have been working diligently alongside the Small Business Administration to put these changes into effect for NIH, as described on the SBIR/STTR Reauthorization Act of 2011: NIH Implementation of Key Changes website. As the 2014 HHS-wide SBIR and STTR Omnibus solicitations were announced last week, I thought it would be good to highlight some of these important reforms.
- Venture capital-backed companies: Small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds and/or private equity firms can now apply to the NIH SBIR program.
- Switching between SBIR and STTR: Traditionally applicants with a Phase I STTR award or a Phase I SBIR award would only be able to move on to applying for a Phase II STTR or SBIR award respectively. However, they may now switch between the SBIR and STTR programs between Phases (I to II and II to IIB).
- Technical assistance programs: NIH has expanded the Niche Assessment Program for active Phase I awardees, and the Commercialization Assistance Program for Phase II awardees, to include both SBIR and STTR awardees.
- Increased outreach efforts: NIH funds biomedical research funding in all states. As part of the reauthorization requirements, NIH will continue targeting historically underserved geographical areas known as Institutional Development Award (IDeA) states, and populations, including women-owned small businesses (WOSB) and small disadvantaged business (SDB). NIH’s goal is to continue spreading awareness about the SBIR and STTR programs to these groups, and to increase the number and quality of their SBIR and STTR applications.
- New guidance on application submissions above the statutory hard budget caps: more information in Appendix A of the omnibus solicitation.
- Coming soon – direct SBIR phase II FOA: A funding announcement that permits direct SBIR Phase II applications will be coming soon – stay tuned to the NIH SBIR homepage and the SBIR/STTR listserv for details.
Small businesses are important for commercializing innovative medical technologies and these programs are one way which NIH supports them. The SBIR/STTR programs are unique in many ways – for example, the number of SBIR applications received over the past decade are a different picture than the overall rise in research project grant applications. But like all of our programs, the SBIR and STTR program application success rates declined in 2013. Review the NIH Data Book for more data or visit sbir.nih.gov, to learn more about the SBIR/STTR programs.
Although we have heard a lot of talk about the affordable care act, there seems to be little venue for SBIR proposals that deal with the issue of making exiting biologics, more affordable by innovative technologies that reduce manufacturing costs ( and ultimately national health care costs) or for making modifications of existing therapeutics. At least, this has been our experience. These type of projects are not considered ‘innovative’ or they are not broad enough in impact. Reviewers are not impressed with these efforts. Our feeling is that even if its just reducing costs of a $7 billion a year drug down to $3.5 billions, isn’t that a step in the right direction?
There should be some avenue for those of us who want to use our science and experience to develop strategies to ‘repupose’ existing biologics. In this regard the Europeans are far ahead of us, the Wellcome Trust, for example, seeks out such research proposals, repurposing of existing drugs is high on their agenda. But in the US it is not.