Small Business Transition Grant For Early Career Scientists (R42 Clinical Trial Not Allowed)

Purpose Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI) intend to support early career academic scientists interested in transitioning to entrepreneurship while also supporting the transfer of technology from academic laboratories into small businesses. Both small businesses and universities are drivers of technological innovation in the United States (U.S.), often working together to advance innovative ideas into products that can benefit the U.S. population. While most NIH funding supports basic research in university laboratories, the NIH also supports innovative technology development in U.S. small businesses through its SBIR & STTR programs. As technologies transition from academic discovery to small businesses, two common challenges arise, identifying the right team with the right expertise to take the product into a small business, and funding for early stage technology development. This FOA seeks to address both challenges simultaneously by having two equally important goals throughout both phases of the award: entrepreneurial mentoring support, and product development support. This FOA proposes a new and unique Fast-Track only award structure comprised of a Phase I STTR that transitions to a Phase II SBIR. An STTR award is a collaborative award made to small businesses that are working closely with a university. While both SBIR and STTR grants are only awarded to small businesses, the STTR program allows a significant amount of STTR-funded work to be conducted at a partner university site and allows the Principal Investigator (PI) to maintain his or her employment at a university during the phase I period. Therefore, awards made under this FOA will begin as a Phase I STTR to allow the candidate to complete proof of concept studies at the academic site and prepare the technology to move into the small business. After completion of the STTR phase I activities, transition to a Phase II SBIR award will only occur after demonstration that stringent criteria have been met that include a demonstration of ongoing mentoring as well as having achieved technical milestones (more information under Section IV. Application Submission Information). A key component of the small business transition grant is mentoring. Mentoring is not traditionally a factor in SBIR/STTR funding decisions, however here mentoring is critical to facilitate the transition from junior academic scientist to entrepreneur. Therefore, the mentoring team that supports the candidate will be a critical factor in peer review. The ideal candidate for this small business transition grant is a postdoctoral researcher who participated in technology discovery during their academic work and is now ready to move to a small business and has access to an experienced team of experts to help advise them. To be responsive to this FOA, proposed projects MUST pertain to one of the participating Organizations/Institutes, and propose the development of a technology that fits into at least one of the following categories: (1) Therapeutics and Preventative Agents; (2) Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; or (3) In Vitro and Ex Vivo Diagnostics and Prognostics. Background and Rationale Since its inception in 1982, the NIH SBIR program has provided US small businesses with critical seed funding to support the development of a broad array of commercial products for the detection, diagnosis, treatment, and prevention of disease. In 2019, National Institutes of Health (NIH’s) SBIR/STTR programs invested over $1 billion in small businesses (SBCs), with NCI SBIR administering the largest share of all the NIH Institutes (ICs) with an annual budget of $173 million. The SBIR/STTR program at NCI supports the development, translation, and commercialization of novel therapeutics, devices, diagnostics, and processes that are aimed at reducing the burden of cancer. Retrospective economic impact analysis of NCI SBIR/STTR Phase II grants from 1998-2010 indicated there was a substantial rate of commercialization, with 247 products commercialized from 690 Phase II grants. Sales of products and services associated with these grants were reported at $9.1 billion. Based on the reported sales, economic modeling calculated that over 107,000 jobs were created and $26.2 billion of economic output was produced. Academic investigators contribute significantly to NCI’s SBIR/STTR programs. Over half of NCI’s SBIR&STTR budget between 2008-2017 was paid to U.S. universities in the form of subawards. The critical role of academia in the SBIR program was recognized by a 2018 National Cancer Advisory Board (NCAB) external working group that evaluated the NCI SBIR program. The NCAB recommended that the NCI SBIR Development Center increase its efforts to connect with and encourage academic scientists who are interested in pursuing entrepreneurship. As the model for technology development evolves in academia, and universities increasingly encouraging junior scientists rather than tenured faculty to become entrepreneurs, additional mentoring support may prove to be a critical factor for success. This FOA is intended to support the mentored transition of these junior scientists as they transition to entrepreneurship. Research Objectives and Requirements Objectives of this FOA The dual objective of this FOA is to support the transition of early career scientists interested in entrepreneurship, while simultaneously supporting the advancement of technologies out of academic research laboratories and into small U.S. businesses. Academic institutions are increasingly turning to postdocs and early career scientists as the best candidate to move into a small business with a new innovative academic discovery. Tapping early scientists to become entrepreneurs allows academic faculty to maintain their focus on hypothesis-driven research in their academic lab. NIH Institutes and Centers support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence. This FOA is the first SBIR mechanism with a focus on mentored career development at NIH to aid the transition of early career scientists to entrepreneurship. Key Requirements for this FOA A. Requirement for strong mentors Mentoring is a key component of this FOA. Therefore, the mentoring plan in the NCI and NHGRI Small Business Transition Grant is a central aspect of the peer review. For the small business transition grant, each candidate must identify at least two mentors to support the candidate in areas of technology development and business development. Each application must: Identify a technical mentor and a business development mentor. The purpose of the technical mentor is to provide feedback on the appropriate milestones for technology development. The purpose of the business development mentor is to advise the candidate on how to identify appropriate technical milestones for commercial development and how to best maintain a milestone-driven research plan. Each mentor must provide a letter of support that outlines their commitment to the development of the technology and the PI as outlined in the FOA. The identified mentors must meet the following criteria: Technical mentor: The technical mentor should be the head of the academic laboratory from where the technology was developed. Some exceptions may be made if this person is a key opinion leader in the same field as the technology being developed. This person may also be a co-founder, owner, or a C-level executive in the small business. The technical mentor should guide the PI of STTR award (e.g., postdoc) in scientific matters. Business Development (BD) Mentor: The BD mentor could be an experienced BD executive, an experienced entrepreneur, an employee of a university’s technology transfer/innovation office that has experience in business development within the appropriate biomedical sector, or an entrepreneur-in-residence (EIR). The BD mentor should have experience as an executive in an industry setting or have experience in mentoring startups, and ideally this person would have track record of mentoring emerging entrepreneurs. Other mentors: Applicants can include additional mentors or mentoring teams that will help them identify appropriate milestones and a strategy to complete them. The application must describe how each mentor will contribute to the success of the candidate and the success of the technology. In addition to high quality and committed mentors, each project will be required to complete I-Corps at NIH (https://sbir.cancer.gov/programseducation/icorps). I-Corps at NIH is an entrepreneurial training program in which participants are required to interview at least 100 stakeholders to better identify commercialization opportunities that address unmet needs. Note: I-Corps at NIH is offered to Phase I SBIR/STTR awardees, and completion of I-Corps will be required for a project to transition to Phase II. B. Eligibility The purpose of the Small Business Transition Grant is to support early career scientists who are transitioning from an academic research setting to a small business. Therefore, eligibility it limited to early career scientists. For more information on eligibility, see section III below. C. Scientific/Technical Scope Applications will be considered if they fall within the mission of one of the participating Organizations/Institutes, and the proposed technology falls within at least one of three technical/scientific areas: (1) Therapeutics and Preventative Agents; (2) Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; or (3) In Vitro and Ex Vivo Diagnostics and Prognostics. Non-Responsive Applications The following types of studies are outside the scope of this FOA. Applications proposing such studies will be considered non-responsive and will not be reviewed: Technology development projects outside of one of the Organizations/Institutes listed at the top of the FOA. Digital health technology development. Educational tool/resource development. Research tool development.