Created by on 07/17/2012

On July 11th, the National Institutes of Health (NIH) Scientific Management Review Board (SMRB) met to discuss its ongoing review of the agency’s Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) programs and its newest charge to develop parameters to assess the value of biomedical research (click here to view the meeting agenda). Both of these efforts owe their origins to the agency’s and the nation’s current fiscal challenges. In his opening remarks, NIH Director Francis Collins, MD, PhD, lamented the 20 percent loss of purchasing power since the end of the agency’s budget doubling in 2003. He went on to say that in this “time of great uncertainty” NIH needs to look at ways of doing more with less.
With President Obama’s December 31st, 2011 signing of the legislation reauthorizing SBIR/STTR programs, NIH will have to increase the portion of its budget set-aside for small business grants. Despite the agency projection of flat budgets in the near term, the reauthorization calls for gradual increases in the set-aside from 2.5 to 3.2 percent for SBIR and 0.3 to 0.45 percent for STTR over the next six years. One of the ways the agency is considering absorbing the increase is to fund phase II clinical trials through the SBIR program. Another option under review is funding the expansion of the National Heart Lung and Blood Institute (NHLBI) Centers for Accelerated Innovations (CAI) through a trans-NIH project. CAI facilitates the translation of scientific discoveries into marketable products by providing business development, regulatory, intellectual property, product development, and project management support to investigators. Funding this expansion would be possible because one of the new provisions in the reauthorization allows NIH to spend $5 million of the STTR set-aside on pre-competitive proof-of-concept programs. Finally, the three-year pilot initiative that will provide NIH with the ability to charge three percent of the SBIR set-aside for administration, outreach, and statute compliance will further help to ease the impact of the increased set-asides.
As part of the SMRB review of the SBIR/STTR programs, the National Cancer Institute, National Eye Institute, NHLBI, and National Institute on Drug Abuse were invited to describe their respective programs and provide recommendations. These institutes were chosen to represent the diversity of NIH SBIR/STTR programs in terms of program size, reliance on investigator-initiated applications, market opportunities, utilization of dedicated SBIR program staff, and other parameters. The institute recommendations all echoed the same themes: the need for a modified peer review approach, the importance of flexibility in award size, and the value of robust metrics to track success.
The Defense Advanced Research Projects Agency (DARPA), the Department of Energy, the National Science Foundation, and the Small Business Administration were also invited to discuss their SBIR/STTR programs. Compared to NIH, all of these agencies have shorter spans between application submission and the disbursement of grant funds, and members of the SMRB and Dr. Collins were especially interested in exploring how this was achieved. The consensus was that NIH’s peer review process might not be optimal for supporting the kinds of transformational projects targeted by SBIR/STTR and that it is the primary bottleneck in the award process. SMRB member and former Administrator of the National Aeronautics and Space Administration Daniel Goldin was quick, however, to point out that there are important differences in the missions and the metrics of success between NIH and some of the other science agencies. Unlike DARPA, which is located within the Department of Defense (DOD), “the NIH is not the ultimate consumer” of developments funded by the program, said Goldin. For DARPA, the metric of success is the transfer of products to DOD or another agency, whereas the NIH mission is to expand fundamental knowledge, and peer review has been a critical foundation of that effort. Dr. Collins highlighted decreasing award cycle times and developing metrics as priority areas for improvement. With regard to cycle times, the NIH Director said that he was “open to different methods than we’d use for R01 awards.” The next step of the SMRB review process will be to meet with SBIR/STTR stakeholders on October 3rd.
The final portion of the SMRB meeting was devoted to the rollout of the Board’s newest charge to examine the value of biomedical research. To clarify, Dr. Collins stated that he didn’t “expect the SMRB to become an economic think tank,” but that he would like the Board to “lay out the parameters.” He noted that NIH faces constant pressure to provide economic justifications for its work and that “the particular focus and need is to put impact arguments in an economic context.” The SMRB affirmed the importance of the undertaking with Board Chair Norman Augustine remarking that “here in Washington, economics is the coin of the realm.”