Small Business Technology Transfer Programs Research Articles

Abstract IA009: National Cancer Institute Small Business Innovation Research Development Center NCI SBIR & STTR resources for commercializing innovative cancer prevention

Abstract The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs at the National Institutes of Health (NIH) serve as one of the largest sources of early-stage capital for technology commercialization in the United States (US). In FY2021, the National Cancer Institute (NCI) SBIR and STTR Programs provided approximately $182M in non-dilutive funding to US small businesses and managed over 400 different projects. By supporting startups and other small businesses in the cancer space, the NCI SBIR and STTR Programs act as catalysts of innovation for novel technologies and products to achieve NCI’s mission to prevent, diagnose, and treat cancer. Staffed by a dedicated team of scientists with wide-ranging technology and industry experience, the NCI SBIR Development Center provides both funding and non-funding resources to US small businesses all aimed at translating technologies to the clinic to help cancer patients and providers. During the past 5 years, NCI has provided SBIR/STTR funding to approximately 25 companies who are developing novel cancer prevention agents. Companies focused on prevention of several indications such as colorectal cancer, oral squamous cell carcinomas, and human papillomavirus-related cancers. Award sizes ranged from $200k-$2M and included support for companies with technologies in the preclinical and clinical stages of development. NCI provided opportunities for non-funding support as well, including entrepreneurial training programs such as I-Corps™ at NIH and programs to facilitate connections between innovators and potential investors. Whether a technology is in the preclinical or clinical stage of development, NCI can help small businesses translate their innovative research to the marketplace so they become available to healthcare providers and their patients. Citation Format: Jonathan Franca-Koh. National Cancer Institute Small Business Innovation Research Development Center NCI SBIR & STTR resources for commercializing innovative cancer prevention [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr IA009.

(Invited) National Science Foundation Innovation Programs

This presentation will discuss the challenges faced by academic institutions when trying to commercialize the output of federally funded research. Through the Partnerships for Innovation (PFI) program, the National Science Foundation (NSF) offers researchers from all disciplines of science and engineering the opportunity to perform translational research and technology development, catalyze partnerships and accelerate the transition of discoveries from the laboratory to the marketplace for societal benefit. PFI has five broad goals, as set forth by the American Innovation and Competitiveness Act of 2017 (“the Act”, S.3084— 114th Congress; Sec. 602. Translational Research Grants): (1) identifying and supporting NSF-sponsored research and technologies that have the potential for accelerated commercialization; (2) supporting prior or current NSF-sponsored investigators, institutions of higher education, and non-profit organizations that partner with an institution of higher education in undertaking proof-of-concept work, including the development of technology prototypes that are derived from NSF-sponsored research and have potential market value; (3) promoting sustainable partnerships between NSF-funded institutions, industry, and other organizations within academia and the private sector with the purpose of accelerating the transfer of technology; (4) developing multi-disciplinary innovation ecosystems which involve and are responsive to the specific needs of academia and industry; (5) providing professional development, mentoring, and advice in entrepreneurship, project management, and technology and business development to innovators. In addition, PFI responds to the mandate set by Congress in Section 601(c)(3) of the Act (Follow-on Grants), to support prototype or proof-of-concept development work by participants, including I-Corps participants, with innovations that because of the early stage of development are not eligible to participate in a Small Business Innovation Research Program or a Small Business Technology Transfer Program. Finally, PFI seeks to implement the mandate set by Congress in Section 102(c)(a) of the Act (Broader Impacts Review Criterion Update) by enhancing partnerships between academia and industry in the United States and expanding the participation of women and individuals from underrepresented groups in innovation, technology translation, and entrepreneurship. The presentation will describe other entrepreneurship, innovation and industrial partnerships programs offered by the NSF to catalyze the commercialization of high-risk, high-impact technologies.

How does agency workforce diversity influence Federal R&D funding of minority and women technology entrepreneurs? An analysis of the SBIR and STTR programs, 2001–2011

US Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide Federal research and development (R&D) grants to technology ventures. We explore how grantor demographic diversity explains why demographically diverse grantees experience different odds for successfully transitioning from initial to follow-on R&D grants. We empirically analyze 52,126 Phase I SBIR/STTR awards granted by 11 Federal agencies (2001–2011). We find a positive association between agency workforce diversity and Phase II funding for Phase I grantees, but minority and women technology entrepreneurs are less likely to receive this funding than their non-minority and male counterparts. Agencies valuing workforce ethnic diversity or leveraging gender homophily positively influence the likelihood of women technology entrepreneurs obtaining Phase II funding. We discuss evidence-based implications for policy and practice.

Stem Cell Biotech: Seeking a Piece of the Action

Venture capital groups and big pharma have largely held back from investing in biotech companies focused on regenerative medicine. Will it take a clinical bull's eye to bring venture capitalists and big pharma into the cell therapy arena?

The FDA Division of Oncology Initiative with the NCI SBIR/ STTR Programs

3173 Small businesses normally do not have a complete range of expertise and resources necessary to bring products to market from initial discovery through the expensive development phases. The NCI and other federal institutions support the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to help fill this need. The SBIR and STTR programs are granting programs for small business and provide a mechanism for small business to collaborate with research institutions to engage in federally funded research and development. The goal of these programs is to provide resources for innovative research for discovery and early-stage development to ensure that interested commercial partners will continue product development and, ultimately, bring a new product to market. The CDER Division of Oncology Drug Products (DODP) has collaborated with the NCI to establish educational and training resources for the NIH SBIR/STTR program grantees. Grantees’ lack of regulatory knowledge necessary to file Investigational New Drug Applications (INDs), for product development may lead to inefficient use of resources, lost opportunities, and potentially to premature termination of development. The DODP team has been working with the NCI SBIR/STTR program managers to identify specific issues leading to these inefficiencies and to develop novel solutions. DODP reviewers presented an overview of the regulatory requirements for submitting INDs for oncology drug products at the annual NIH SBIR/STTR conference (http://grants.nih.gov/grants/funding/SBIRConf2004/presentations.htm). We will present an overview of the DODP-SBIR/STTR interaction and discuss the chemistry, pharmacology/ toxicology, and clinical regulatory requirements for submitting an IND. No significant financial relationships to disclose.

Neurotechnology: expanding opportunities for funding at the National Institute of Mental Health

The National Institute of Mental Health recognizes the importance that creative development of technology and methodology play in brain and behavioral science research. This institute is making major efforts to- support such development through specific initiatives, like the Human Brain Project. In addition, this Institute is actively building bridges between business and academic research communities to make optimal use of funds for the research and development of commercially viable technologies relevant to all aspects of the Institute's mission through the Small Business Innovation Research and Small Business Technology Transfer Programs. Together, these efforts will culminate in a more vigorous scientific enterprise, and ultimately benefit the entire mental health community and society.