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Pages 1-18

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From page 1...
... . The two programs represent a critical component of NIH's mission-specific development of public health innovations, having been instrumental in helping academic laboratory research achieve markers of nascent commercial development, such as patents and earlystage clinical studies.
From page 2...
... While the programs have produced notable outcomes, their complexity and the heterogeneity of their outreach and selection processes translate to challenges, especially in underserved communities. A body of evidence accumulated over the past two decades documents the significant financial and public health impact of NIH funding, primarily R01 grants, but also the SBIR and STTR grants, which have funded notable technological advances in new drugs and devices.
From page 3...
... This study mandate was expanded in the National Defense Authorization Act for Fiscal Year 2012, wherein Congress directed agencies with SBIR program budgets of more than $50 million to engage with the National Academies to conduct quadrennial assessments of each agency's SBIR and STTR programs.1 The assessments called for in the congressional mandate are expected to examine how the SBIR and STTR programs have stimulated technological innovation, used small businesses to meet federal research and development needs (SBIR) , and stimulated technology transfer (STTR)
From page 4...
... The qualitative evidence used by the committee included discussions with program managers from each institute and center administering SBIR/STTR awards and from the Center for Scientific Review (CSR) ; presentations by personnel from NIH's Small Business Education and Entrepreneurial Development (SEED)
From page 5...
... Finding 3-7:4 The success stories reported on NIH's website and discussed by SBIR/STTR program managers demonstrate that the NIH SBIR and STTR programs fulfill their broad missions by providing funds for U.S. small businesses to conduct rigorous and commercially relevant biomedical research and innovation.
From page 6...
... that allowed them to produce meaningful innovation outputs. Finding 5-4: NIH SBIR/STTR-funded firms do better than unfunded applicants on various commercialization metrics and outcomes.
From page 7...
... However, outreach from the SBIR/STTR programs to underserved groups is not coordinated, and there has been little improvement in the share of applications from or awards to these groups in the past 20 years. Finding 3-2: SBIR/STTR program managers and NIH leadership lack a systematic approach for outreach to potential NIH SBIR/STTR program applicants from underserved groups, including women who own small businesses, socially and economically disadvantaged small business owners, and small businesses in historically underutilized business zones.
From page 8...
... Finding 3-5: Commercialization programs offered within NIH for SBIR/STTR awardees are duplicative and fragmented across the ICs, as well as programs offered by regional and local life sciences incubators and accelerators. KEY RECOMMENDATIONS Based on its findings, the committee formulated 11 recommendations intended to help NIH and Congress continue to strengthen the SBIR/STTR programs.
From page 9...
... SBIR/STTR review and selection processes are lengthy compared with those of other federal agencies. As discussed above, the SBIR/STTR programs across the institutes and centers are extremely different, with differing award amounts, time frames, selection and review processes, and commercialization assistance.
From page 10...
... Recommendation 3-5: The NIH director should work with NIH's Small Business Education and Entrepreneurial Development Office to change the criteria for selection by both NIH ICs and the Center for Scientific Review by reclassifying SBIR/STTR awards as small business innovation awards rather than research and development awards. If NIH determines that it does not have the authority to reclassify these awards, Congress should consider granting a waiver from the peer review criteria that are legislatively required for NIH's research grants and research and development contracts.5 In conjunction with those changes, SBIR/STTR program managers and review panelists should have appropriate experience to                                                              5 After a prepublication version of the report was provided to NIH, this sentence was added to the recommendation to emphasize that there is a legislative alternative to NIH's reclassifying the SBIR/STTR grants as small business innovation awards, as discussed in Chapter 3.
From page 11...
... Recommendation 4-2: The NIH director should require that the NIH RePORT Support Team work to ensure that data in RePORTER are consistent with other government data on commercial outcomes of SBIR and STTR awardees, such as data available from the U.S. Patent and Trademark Office government-interest statements.
From page 12...
... c. Additionally, Congress should consider requiring that the SBIR/STTR public database contain information on research partnerships for SBIR awards, complementing its current requirement to report this information for STTR awards.
From page 13...
... Finding 3-5: Commercialization programs offered within NIH for SBIR/STTR awardees are duplicative and fragmented across the ICs, as well as programs offered by regional and local life sciences incubators and accelerators. Finding 3-6: NIH ICs do not view tracking the impact of SBIR/STTR awards as a priority, and there is no systematic approach across ICs for tracking outcomes and impact, nor are there consistent metrics of success for these grants and contracts.
From page 14...
... Finding 4-1: Persistently low levels of NIH SBIR/STTR program participation among women and minorities remain a major unresolved challenge for NIH. Finding 4-2: Additional funding does not improve representation of women or minorities in terms of receiving NIH SBIR or STTR awards.
From page 15...
... Recommendation 3-5: The NIH director should work with NIH's Small Business Education and Entrepreneurial Development Office to change the criteria for selection by both NIH ICs and the Center for Scientific Review by reclassifying SBIR/STTR awards as (Continued)
From page 16...
... Recommendations Regarding the Impact of the NIH SBIR/STTR Programs (Chapter 5) Recommendation 5-1: The NIH Small Business Education and Entrepreneurial Development Office should systematically monitor commercialization outcomes for SBIR/STTR recipients in Food and Drug Administration databases for commercialized                                                              6 After a prepublication version of the report was provided to NIH, this sentence was added to the recommendation to emphasize that there is a legislative alternative to NIH's reclassifying the SBIR/STTR grants as small business innovation awards, as discussed in Chapter 3.
From page 17...
... Doing so would inform NIH's own collection of "success stories," as well as analyses of the health and economic impacts of specific linked products. Recommendation 5-2: To facilitate evaluation of the impact of SBIR and STTR grants, Congress should consider requiring amendments to the data collection requirements for the SBIR/STTR public and government databases mandated in the Small Business Act.


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