SBIR/STTR at the National Institutes of Health (2015) / Chapter Skim
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3 Program Initiatives at NIH
3 Program Initiatives at NIH
Pages 81-103
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From page 81... ...
. It also reviews some of the other agency-wide initiatives, most notably the occasional provision of awards considerably larger than stated in the SBA guidelines (these awards are legal on the basis of waivers provided by SBA)
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From page 82... ...
The model also ensures that program officers with deep expertise in IC interests and priorities manage SBIR/STTR awards. Some of the larger ICs did assign the management of SBIR awards to an individual staff member who effectively became the program officer for SBIR/ STTR, but this was not a standard model.
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From page 83... ...
In addition, NCI has developed a new funding strategy -- Bridge awards -- and a new investor forum for bringing together NCI SBIR/STTR companies and potential investors. Bridge Awards NCI has pioneered a variant on Phase IIB awards, which are designed to support companies entering clinical trials (see Chapter 4 for more detail)
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From page 84... ...
They help companies connect with potential funders and strategic partners earlier in the process than would normally be the case by providing partners with a boost to the company that does not dilute their equity. While a funding match by a private-sector investor is not strictly required, companies with a match can and do have a competitive advantage.
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From page 85... ...
I-Corps The I-Corps program is described in more detail under NIH-wide innovations below. However, it is important to note here that the I-Corps initiative, although open to all ICs, has been driven in large part by NCI SBIR leadership, and that NCI continues to utilize most of the available slots in the program.
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From page 86... ...
• In some cases, program officers and grants management specialists might lack expertise in advising small businesses on commercialization issues and managing awards. ERNSIT recommended some significant changes, most notably that NHLBI should introduce an entirely new office staffed with personnel dedicated to program activities, which would provide "scientific, business management, regulatory, and outreach expertise to coordinate and accelerate translational activities at the NHLBI."6 Within this new structure, ERNSIT also recommended: • Enhanced and expanded partnerships for outreach • More strategic use of funding opportunity announcements to align SBIR/ STTR with Institute priorities • Strategies to address pre- and post-SBIR funding gaps • Improved evaluation and assessment All of these recommendations were adopted by the NHLBI governing council in May 2010, and NHLBI's Office of Translational Alliances and Coordination (OTAC)
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From page 87... ...
program.7 These programs aim to address three issues identified by the ERNSIT report: lack of funding for very early-stage commercialization activities; lack of commercialization expertise among scientists; and lack of access to additional commercialization resources. There are three NCAI Centers located respectively at the Boston Bio edical m Innovation Center, the Cleveland Clinic, and the University of California in Los Angeles, and three REACH centers located respectively at the University of Minnesota, the Long Island Biomedical Hub, and the University of Louisville.
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From page 88... ...
Estimates by NHLBI staff suggest that, excluding contracts, targeted funding opportunities now account for perhaps 15 percent of SBIR/ STTR funding (see Box 3-1 for examples)
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From page 89... ...
This effort to align with industry sector conferences focused on early-stage activities is a potentially important initiative. Post Phase II Awards NHLBI operates two award programs to help bridge the gap between the end of SBIR/STTR Phase II and full commercial opportunities.
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From page 90... ...
According to NHLBI, the most recent Boston Regional Innovation Conference allowed 19 local companies to present their SBIR technologies, of which 3 entered into materials transfer agreements and 1 received a $1 million funding round led by a venture firm.13 NHLBI also runs its own disease-specific conferences and worships, which have recently included workshops on Translating New Therapeutics for Sickle Cell Disease to the Market Place and Precision Therapeutics Delivery for Lung Diseases. One of the challenges for small biosciences companies is to make the appropriate connections with what are effectively the primary sources of funding for clinical trials and then product development and marketing: big pharmaceutical companies.
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From page 91... ...
Meanwhile, survey evidence and case study discussions revealed considerable demand among awardees for more support in relation to commercialization -- including in relation to FDA approval for clinical trials. Of course, because they were initiated recently, it is too soon to determine whether these new approaches, while addressing a key challenge, are having a net positive impact on program outcomes, and indeed whether that impact is worth the additional cost of the more focused management structures that they require.
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From page 92... ...
15 Andrew Kurtz, "The NCI SBIR Program: An Overview of New Funding Opportunities and Strategies for Employing Lean Startup Tools to Drive Success in Your Small Business," AACR presentation, April 20, 2015.
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From page 93... ...
SOURCE: Andrew Kurtz, "The NCI SBIR Program: An Overview of New Funding Opporunities and Strategies for Employing Lean Startup Tools to Drive Success in Your t Small Business," AACR presentation, April 20, 2015, p.
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From page 94... ...
However, the program currently serves only a small fraction of Phase I companies at NIH, and it is unclear whether there are either plans or resources to expand the program to serve larger numbers. Phase IIB This program is designed to provide additional support for development efforts pursued in a previously funded NIH SBIR Phase II, often for grant for products or technologies that require ultimate approval by a Federal regulatory agency.16 Although the amount of funding needed for a trial varies substantially, Phase IIB is not designed to fully fund the process through the end of Phase 3 clinical trials.
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From page 95... ...
SOURCE: Based on data from National Institutes of Health. TABLE 3-1 Phase IIB and Clinical Trials Percentage of Respondents NIH SBIR STTR Phase IIB Total Awardees Awardees Awardees Process abandoned 35.5 35.9 33.3 5.3 Preparation under way for clinical trials 34.4 35.5 28.2 47.4 IND granted 4.7 4.1 7.7 10.5 In Phase 1 clinical trials 4.7 5.1 2.6 In Phase 2 clinical trials 9.4 7.4 20.5 15.8 In Phase 3 clinical trials 2.3 1.8 5.1 Completed clinical trials 9.0 10.1 2.6 21.1 BASE: NIH PROJECTS REQUIRING 256 217 39 19 FDA APPROVAL NOTE: If the large portion of awardees who were not able to be reached by the survey contained a large percentage of companies that went out of business because they could not proceed with FDA approval, the survey results may understate the number of those requiring FDA approval and the percentage who did not proceed with FDA approval.
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From page 96... ...
Program Limits on Award Size at the National Institutes of Health," Science and Technology Policy Institute memo, September 9, 2013. Extra-large Awards NIH is well known in the SBIR community for providing awards that are larger than those set forth in SBA guidelines (see Box 3-2 for size rules)
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From page 97... ...
Program Limits on Award Size at the National Institutes of Health," Science and Technology Policy Institute memo, September 9, 2013, pp.
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From page 98... ...
Overall, the number of larger awards grew steadily from FY2001 to FY2011. At about the time of the 2011 reauthorization of the SBIR/STTR programs, when new limits were imposed and blanket agency level waivers were no longer ermitted, p the number of larger awards stopped growing and, in 2014, dropped 24 percent.
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From page 99... ...
The steady growth trend in both larger awards and their associated funding should be put in context. Table 3-4 shows these larger Phase II awards as a percentage of total awards and funding for Phase II during this period.
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From page 100... ...
In reality, funding additional awards would likely have meant funding weaker applications, as acceptance moved farther down the list of fundable applications. Therefore, it is
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From page 101... ...
However, it is notable that three of the four projects reporting at least $50 million in related sales received larger awards and that this group accounted for four of the nine projects reporting at least $20 million in sales. This is only the first review of this issue.
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From page 102... ...
102 SBIR/STTR AT THE NATIONAL INSTITUTES OF HEALTH 35 30 25 Percent Share 20 15 10 5 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Fiscal Year Award = $1.5M - $2.25M Award>$2.25M FIGURE 3-8 Share of large and extra-large awards in all NIH SBIR/STTR funding for Phase II (excluding Phase IIB)
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From page 103... ...
PROGRAM INITIATIVES AT NIH 103 suggest that even though there is little difference in outcomes for most awards, the large award companies generated more of the largest reported outcomes than their share of all awards would lead us to expect.
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