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Panel II — SBIR at the National Institutes of Health
Pages 72-92

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From page 72...
... He said that his own committee, the House Science Committee, was one of those five, and that Congress had re-examined the SBIR program three times since its inception in 1982. Thanks to the efforts of the program managers responsible for each agency's SBIR activities, he said, the program had worked quite well and produced strong results.
From page 73...
... In carrying out this mission, the NIH supports basic, applied, and clinical research to better understand the complex processes underlying human health and to acquire new knowledge that will help prevent, diagnose, and treat human diseases and disabilities. "From the Test Tube to the Medicine Cabinet" The SBIR program plays an integral role in the NIH mission, said Ms.
From page 74...
... · Another achievement is that the SBIR program and certainly the STTR program have each created avenues for connecting basic knowledge to the marketplace through university-industry partnerships, which is an impor tant dimension in our rapidly evolving economy. Another achievement is that the SBIR has assisted NIH, and indeed all federal agencies, in ad dressing agency-critical technology research areas and in responding to national priority areas.
From page 75...
... NIH data show that 75 to 80 percent of the companies receiving the awards have earned between one and three previous awards. Opportunities for the Study Panel The plan for the comprehensive SBIR study, said Ms.
From page 76...
... Goodnight, is that the methodology of the study must address how agencies incorporate their own culture and processes in achieving the congressionally mandated goals of the program. Challenges for the Study Panel While the SBIR study brings numerous opportunities, she said, it also poses a number of challenges, including the following: · Identifying commonalities and unique features of each agency's programs; · Developing a systematic and comprehensive methodology that adheres to the goals of the study; · Reconciling existing knowledge bases within agencies while maintaining an independent and unbiased global study; · Appreciating redundancies and avoiding undue burdens on respondent companies, where appropriate.
From page 77...
... Thus NIAID, 13 The National Institutes of Health supports research using both grants and contracts. About 95 percent of NIH SBIR awards are made through the grant (assistance)
From page 78...
... The infrastructure had a core of clinical research capability, but to get to that point requires a huge investment in both basic research and product development, including preliminary information that the product may indeed be of value. "No company is going to invest hundreds of millions of dollars in a concept," she said, "until there is a good idea how that concept works." In order to speed concept development, the Institute offers a contract process that includes opportunities to test a certain product at a preclinical stage.
From page 79...
... TABLE 1 FY2002 NIAID Biodefense Initiatives Initiative Title Target Audience NIAID Small Business Program on Small Business Bioterrorism-Related Research (SBIR/STTR) Rapid Response Grant Program on Academia Bioterrorism-Related Research Exploratory/Developmental Grants: NIAID-Funded Researchers Technology Applications Partnerships for Novel Therapeutic, Small and Large Businesses Diagnostic, and Vector Control Strategies in Infectious Diseases Investigator-Initiated Small Research Grants New Researchers/changing fields U.S.-Based Collaboration in Emerging Academic and Industrial Viral and Prion Diseases Researchers Development & Testing of Vaccines Industry Against Anthrax
From page 80...
... They knew that responding to their request would require a huge amount of effort on the part of companies: redirecting research in rapid fashion, learning basic principles of biodefense, and asking consultants to determine whether a company's approaches would be amenable to peer review. Nonetheless, the Institute received 184 applications within the short published time limit, revealing both a commitment toward biodefense and very high quality of small-business research.
From page 81...
... The Institute had recognized that it needed to be able to help outside partners in the development of new products by making available the right research resources, such as a vaccine infrastructure or screening process. This allows companies to avoid duplicating or developing processes that are very expensive, and instead to focus their attention on the part of the process they do best, which is research application.
From page 82...
... She said that it costs a company nearly a billion dollars to de velop a vaccine, and that such products have not historically had a high potential for economic return. When liability risk is added to that "huge, huge investment," the choice to pursue a vaccine product adds up to a considerable economic risk to the company.
From page 83...
... ARA is important for proper brain development in infants and is a precursor to a group of hormone-like substances called eicosanoids, which are important in immunity, blood clotting and other vital functions. Most humans ingest ARA in common foods, such as meat, eggs and milk, but DHA is found in only a few foods, such as fatty fish and organ meat.
From page 84...
... Capturing a New Market Today Martek is the sole large-scale commercial manufacturer of these fatty acids, which are sold in various forms, including brands of infant formula, in 70 countries. According to Mr.
From page 85...
... In her Tokyo talk, she said that she described the Bayh-Dole Act of 1982 and its impact on technology transfer.14 At the time of her talk, she did not know that Japan had recently revised national policies in favor of larger support for basic research; she said that Japan had come to invest considerably more in basic research than any other country, including the United States. Japan had not, however, succeeded in translating that support into global competitiveness.
From page 86...
... to learn more about Bayh-Dole and its impact. As a result of the well-studied impact of Bayh-Dole, she recommended that the upcoming SBIR study make careful attempts to quantify the impact of technology transfer from academic institutions, calculate how many small companies actually result from academic technology transfer, and estimate the overall impact of SBIR funding.
From page 87...
... This would include not only the metrics of products, patents, licenses, sales, and other traditional SBIR measures of commercial success, but also publications, citations of those papers, the contribution of companies in training human capital, and other ways of measuring the larger spillover effects of the program. 15 CRISP, the Computer Retrieval of Information on Scientific Projects, is a searchable database of federally funded biomedical research projects conducted at the NIH.
From page 88...
... The current SBIR study, she said, could bring fascinating and useful information about the biomedical revolution and the role of the NIH SBIR program in advancing that revolution. It would also provide an important new perspective on how individual researchers move from the support of university research grants toward the support of SBIR grants, using this new mechanism to translate their academic science into useful products.
From page 89...
... Goodnight's earlier comment, he noted that we now understand that knowledge moves in more complex and circular fashion, with numerous feedback loops between the marketplace and the laboratory. A challenge for the study panel would be to recommend ways to amend some of the "statutory impediments" that reflected the earlier, linear model, that we now know impact the overall program effectiveness, such as narrow time frames, fixed amounts of money, and a "one-size-fits-all" program.
From page 90...
... Strengthening Phase III The second set of recommendations that Congress would like to see, he said, is "bottom-line recommendations." Small business has much to offer, and yet the small-business sector in general is not respected in some parts of government, especially in the procurement arena. He noted that his colleagues on the Small Business Committee had tried for years to raise the awareness of the potential contributions of small business and to "force more doors open for small business." He said that anything the study panel could do to help strengthen "Phase III" and make it as important as the first two phases may be the most valuable contribution it could make to the SBIR program.
From page 91...
... They tended to cluster around the same ZIP codes and academic centers, which suggested a great deal of interaction between the NIH SBIR companies and major academic centers. That interaction, he said, is a truer measure of success than a tally of functional companies.
From page 92...
... Environmental Protection Agency, referred to Mr. Turner's comment that it might be impractical for the study panel to evaluate all ten SBIR agencies.


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