All SBIR/STTR-eligible companies interested in NIH should be aware that the agency offers additional funding and assistance programs to small businesses aside from the standard Phase I, Phase II, and FastTrack opportunities. We recommend that you first discuss any of the following options with your Program Manager to determine if you qualify before applying.
This is an intensive entrepreneurial immersion course to provide Phase I awardee companies with skills and strategies to reduce commercialization risk of their technologies. Designed after the highly successful NSF I-Corps program centered around customer discovery, teams are expected to conduct over 100 interviews in 8 weeks. The program is managed by the National Cancer Institute, but 24 Institutes at NIH and the CDC participate.
Funding Opportunity: PA-19-029 (grants.nih.gov/grants/guide/pa-files/PA-19-029.html)
Learn more at sbir.cancer.gov/programseducation/icorps
For Phase II awardees (from any agency, grant, or contract). This competing renewal program allows applicants to request up to $1 million for up to three years, giving them a total of $3 million to continue R&D efforts from Phase II to bring their product closer to market. Applicants are typically developing heavily regulated products, such as therapeutics or medical devices. The program’s goal is to accelerate commercialization by incentivizing partnerships with third-party investors and strategic partners earlier in the development process. For that reason, applicants are strongly encouraged (and sometimes required) to secure third-party matching funds. Note that any third-party investment received up to one year before the application is submitted will count. Evidence of a third-party funding commitment can be provided at time of submission with a Letter of Commitment. This funding opportunity is offered as SBIR only.
You can apply for a Phase IIB through the Omnibus solicitation or specific funding opportunities released by the individual Institute. The following are the participating institutes: NIA, NIAAA, NIAID, NICHD, NIDCD, NIDDK, NIEHS, NEI, NIGMS, NHLBI, NIMH, NCATS, ORIP, NCI, NHLBI, NINDS.
Learn more at sbir.nih.gov/funding
Commercialization Readiness Pilot (CRP) Program
Previously or currently funded SBIR/STTR Phase II and Phase IIB awardees can receive additional funding for activities that support commercialization, such as design of a regulatory strategy or clinical trial, IND- and IDE-enabling studies and replication of key studies. Significant outsourcing is allowed in a CRP, but the small business is expected to conduct some of the work as well. The following are the participating institutes: NCI, NEI, NHLBI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIHM, NINDS, NLM, NCCIH, NCATS. Funding opportunities: PAR-20-128, PAR-20-129, PAR-20-130
Learn more at sbir.nih.gov/funding#crp
NCATS Bridging Interventional Development Gaps (BrIDGs) program
This NCATS-led program is an assistance program (no funding is provided) for academic, non-profit and SBIR-eligible businesses to assist researchers in advancing therapeutics through late-stage preclinical development toward IND and clinical testing. Selected researchers will collaborate with NCATS experts on this work. Projects that enter should already have a clinical candidate identified. Any disease is eligible.
Learn more at ncats.nih.gov/bridgs
NCATS Therapeutics for Rare and Neglected Diseases (TRND) Program
This is another NCATS-led assistance program to foster researchers from academia, non-profits, government labs, biotech/pharma and even ex-U.S. applicants to support pre-clinical development of therapeutic candidates to treat rare and neglected disorders. Selected researchers will collaborate with NCATS experts and extramural labs. Companies can enter at various stages of preclinical development, but the target disease must meet FDA orphan or WHO neglected tropical disease criteria. The program’s goal is to help de-risk the therapeutic to a point where it is more attractive for adoption by outside business partners.
Learn more at ncats.nih.gov/trnd
Note: SBIR/STTR awardees from non-NCATS Institutes can apply for the BrIDGs and TRNDS programs. Each have a rolling deadline (apply as needed).
Small Business Education and Entrepreneurial Development (SEED)
The SEED program supports early-stage startups and researchers who are new to entrepreneurship. Participants get access to NIH resources, such as Entrepreneurs in Residence, pitch coaching and regulatory support. The goal of the program is to help companies develop relationships with strategic partners and build opportunities to further product development efforts.
Learn more at sbir.nih.gov/resources/entrepreneurs-in-residence/index.htm