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Pages 130-168

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From page 130...
... 4.3.7 Niche products Many companies working with the SBIR program are focused on small markets, where niche products can make a large difference to the lives of a small client group. Analogous to orphan drug research, projects like these are, according to economists, classic cases for government subsidy or support.
From page 131...
... . • Creation of an individualized patient data base, showing the effect of adjustments and creating a longitudinal record for selected metrics The company notes that SBIR awards were used to facilitate its transformation from a hard-wired non-commercial research tool to a wireless, user-friendly commercial clinical and research tool.
From page 132...
... In addition, the NRC Firm and Phase II Recipient Surveys and the NIH Survey all seek to address the question of what would have happened to companies had they not received SBIR awards. 4.4.1 Small business shares of NIH funding SBIR provides support for small business in that it provides funding only to businesses with no more than 500 employees – the SBA definition of a small business.
From page 133...
... This question can be addressed by comparing the level of SBIR funding with that available through all other small business funding mechanisms at NIH (see Figure 4-16 below)
From page 134...
... NIH survey data are comparable, with 64% of respondents anticipating that the projects would have been a "no go" in the absence of SBIR funding. These figures suggest that SBIR often makes the difference between a research project being pursued or not.
From page 135...
... 4.4.3 Company foundation Responses to the NRC Firm Survey indicate that almost 25% of NIH firms that received SBIR Phase II awards were founded entirely or in part as a result of SBIR awards (see Table 4-20)
From page 136...
... 4.4.5 Growth effects While there are no data about the effect of SBIR awards on company growth, except for the employment data discussed above (which do not seek to explain the cause of growth,) the NRC survey did ask respondents to provide their own estimates of SBIR impacts on growth (see Table 422)
From page 137...
... This too is evidence of the powerful impact winning an NIH SBIR award can have on the development of a small business. 4.4.6 Support for women- and minority-owned businesses One of the Congressional mandates for the SBIR program is to support the work of women and minorities in science.
From page 139...
... According to NSF, in 1999 and 2000 women accounted for more than 61% of all life sciences doctorates awarded.15 In that context, maintaining a ten percent share of awards is much less impressive, and NIH might well wish to undertake further analysis to determine why so few of these new doctorates appear to be applying for NIH SBIR funding (note that there is no requirement that a company exist in order to apply for an award, although a company must be formed in order to accept one.)
From page 140...
... . TABLE 4-23 Patents and patent applications Applications Awarded No 249 58.7 280 66.0 Yes 175 41.3 144 34.0 424 100.0 424 100.0 Total 679 305 SOURCE: NRC Survey.
From page 144...
... Publications are featured prominently on many grantee websites, and companies like Advanced Brain Monitoring, SAM Technologies, and Polymer Research all made a point of stating during interviews that their work was of the highest technical quality, as measured in the peer-reviewed publications. Publications therefore fill two important roles in the study of SBIR programs.
From page 146...
... In this chapter, we focus primarily on the latter: areas where NIH might make improvements to its SBIR program. In doing so, we primarily utilize case studies, interviews with NIH staff and other stakeholders, and secondary materials, as well as data from the NRC survey and other statistical sources.
From page 147...
... at NIH award fund their own SBIR awards, using a range of procedures and with different degrees of integration with other programs. Together, these characteristics give the NIH program a unique character, and have informed management of the program in a number of important ways.
From page 148...
... to display their own particular list of initiatives. 5.3.1 Attracting the best applicants The NIH staff notes that average scores for SBIR awards have trended upward (NIH scores range from 100 (best)
From page 149...
... New companies are applying. More than 30% of winning applications are from companies not previously funded by the NIH SBIR program.5 New companies participate in the annual conferences, and hits on the web site continue to increase.
From page 150...
... The distribution of the latter reflects the distribution of scientific and engineering talent, which should tend to predict applications and awards as well. As Table 5-1 shows, there are wide variation in the number of applications per 1,000 scientists and engineers, indicating that scientists and engineers in some states use the SBIR program much more – in fact up to twenty times more – than those in other states.
From page 151...
... 5.3.3 New applicants Awards and applications data from NIH (described in detail in Chapter 3 - Awards) suggest that about 40% of applicants for Phase I have not previously won an NIH SBIR award, and that about 30% of Phase I awards go these companies.
From page 152...
... However, it is also worth noting that some at NIH – including NCI in its institutional response to the NRC program manager survey, suggested that funding for this area was severely constrained: "We need to have annually committed funds to support a reasonable number of HSA and Grants Management staff to travel to the two national meetings as well as the annual NIH SBIR/STTR Conference which is now being held offsite. If the NIH Conference is held in Bethesda, then logistics funds are needed to support the UNEDITED PROOFS
From page 153...
... , which provides a further review. NCI response to NRC Program Manager Survey, April 2006 10 UNEDITED PROOFS
From page 154...
... First, applications in response to a RFA compete for a separate pool of SBIR funding that the IC carves out of its general SBIR pool specifically to serve the RFA. Second, these applications are not selected using the normal Center for Scientific Research (CSR)
From page 155...
... The system has been criticized on a number of fronts, most notably for being inhospitable to innovation,12 and because in tests a significant degree of randomness in results has been identified.13 Nonetheless, peer review is deeply entrenched at NIH, and the selection of SBIR awards at NIH operates through the peer-review that has been implemented agency wide. 5.5.1 Study sections Applications for NIH SBIR awards are received at CSR and are assigned to a particular study section (as review panels are known at NIH)
From page 156...
... Response to NRC program manager survey, April 2006 UNEDITED PROOFS
From page 157...
... . 22 NRC Program Manager Survey April 2006 UNEDITED PROOFS
From page 158...
... , identifying and tallying all non-competing SBIR awards (e.g., Phase II year 2 awards) to which the NIH is already committed, setting aside funds needed for RFAs, and finally calculating the amount of available funds.
From page 159...
... Problems include: • deteriorating quality of reviews as workload increases, and difficulties in recruiting peer reviewers with appropriate expertise; NIH now handles 80,000 applications annually, and recruits more than 15,000 peer reviewers;23 • significant perceptions that scoring has a large random component (a view presented by many case study interviewees, and also by a number of NIH SBIR program officers) ; • conflict of interest problems related to commercialization (an issue raised forcefully by several interviewees and by other stakeholders knowledgeable about the program, but not accepted in the course of NIH agency interviews)
From page 160...
... Conversely, CSR officials noted that review panels had every right to require sufficient data on which to make a reasoned judgment about the viability of a particular technical approach, and that with increasing numbers of applications, more attention was focused on the technical details of each proposal. These concerns are reflected in the advice from Gregory Milman, SBIR Program Manager for NAIAD, who warns applicants in advance: "I strongly recommend that you protect your intellectual property before you describe it in a grant application.
From page 161...
... However, NIH staff report that they spend considerable more effort supporting SBIR applicants and awardees than they do applicants from universities, where the NIH application process is often supported by more experienced staff. Response to NRC Program manager survey, April 2006 27 UNEDITED PROOFS
From page 162...
... scores."29 See discussion of Payline below 28 NHLBI composite responses to the NRC program manager survey, April 2006 29 UNEDITED PROOFS
From page 163...
... applying for and winning Phase I awards during 1992-2004: 50 45 40 35 30 25 % 20 15 10 5 0 2000 2001 2002 2003 2004 2005 Fiscal Year FIGURE 5-2 Percentage of all Phase I applications and awards at NIH from previous non-winners at NIH UNEDITED PROOFS
From page 164...
... See NRC Reports on the SBIR programs at DoD, NSF, DoE, and NASA 30 UNEDITED PROOFS
From page 165...
... • Re-use of applications Internal: Efficiency for the Agency • Move the grant money quickly to right recipients • Minimize use of staff resources • Maximize agency staff buy-in • Reduce appeals and bad feelings 5.5.6.3.1 Efficiency for applicants There are a number of positive components of the current system from the perspective of applicants. These include: • the possibility of resubmission; • broad topic design, which ensures that highly promising research applications are not arbitrarily excluded; • widespread support for the notion of peer review; and UNEDITED PROOFS
From page 166...
... . Nevertheless, some SBIR Program Administrators are enthusiastic and effective.
From page 167...
... NIH has recognized this issue, and several characteristics of the NIH SBIR program fall within what the Summary Report describes as the "gap reduction model" for managing funding cycles and timelines.33 This model is distinguished by its emphasis on supporting applicants using a range of features designed to reduce gaps in funding and decrease the time from initial conception to final product deliverable. Elements in use at NIH include: Multiple annual submission dates.
From page 168...
... • In February 2006, NIH began a pilot study to cut 1½ months from the review process. Forty CSR study sections will participate in this pilot, which will speed the reviews of R01 applications submitted by new investigators.


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