Small Business Government Funding Programs to Support Your Research

Funding your research is a crucial step in product development! One key source of funding not to overlook is government grants. The National Institutes of Health (NIH) is the world’s largest public funder of biomedical research, offering various funding mechanisms, including grants and contracts, to support innovation in the field.

NIH Small Business Programs: America’s Seed Fund

The NIH offers two key small business funding programs: Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR). These programs support early-stage small businesses developing drugs, diagnostics, digital health technologies, research tools, and medical devices. Importantly, they provide funding without taking equity in the company.

  • SBIR allows research partnerships but does not require them. Companies may outsource up to 33% of Phase I research and 50% of Phase II research.

  • STTR requires a formal collaboration between the company and a nonprofit research institution. At least 40% of the research must be conducted by the small business and at least 30% by the research institution. The remaining 30% may be allocated to either party or outsourced.

  • Principal Investigator (PI) Requirements: For SBIR funding, the PI must be employed by the small business and dedicate at least 50% of their employment to the company. In contrast, STTR allows the PI to be employed by either the company or the research institution.

Phases of NIH Funding

  • Phase I: Evaluates feasibility, technical merit, and commercial potential.

    • Budget: Up to $314,363

    • Timeline: 6 months to 2 years

  • Phase II: Supports continued research and development from Phase I.

    • Budget: Up to $2,099,748

    • Timeline: 1 to 3 years

  • Fast-Track: Allows simultaneous submission of Phase I and Phase II applications, provided there is a fully developed Phase II plan at submission. This approach helps minimize funding gaps between the two phases.

SEED Fund Success Story

Achieve Life Sciences, a company that recently received breakthrough therapy designation from the FDA, leveraged SBIR funding to develop its cytisinicline treatment for smoking cessation. This funding enabled Achieve to submit an Investigational New Drug (IND) application for cytisinicline as a potential treatment for patients using nicotine e-cigarettes. With no FDA-approved treatments for vaping cessation currently available, cytisinicline’s approval could represent a significant advancement in this area.

NIH’s SBIR and STTR programs play a vital role in fostering biomedical innovation. Understanding and leveraging these funding opportunities can help propel your research from concept to commercialization.

Interested in securing SEED funding but unsure where to start?

At CRO Consulting, we have firsthand experience successfully securing seed funding for an in-vitro diagnostic testing company. We also have extensive expertise in conducting federally funded studies through BARDA, NIH, and NSF across diverse areas, including AI-driven medical devices, infectious diseases, oncology, pharmaceuticals, and prescription digital therapeutics for both human and animal health. This experience equips us to guide you through the government funding process and help your small or medium business secure the resources needed to succeed.

Contact us today to get expert support in funding your next breakthrough!


References

  1. National Institutes of Health. (n.d.). Grants & funding. NIH. https://www.nih.gov/grants-funding

  2. National Institutes of Health. (n.d.). Understanding SBIR & STTR. SEED. https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr

  3. National Institute on Drug Abuse. (2024, October 31). Success stories: SBIR & STTR programs. NIH. https://nida.nih.gov/funding/small-business-innovation-research-sbir-technology-transfer-sttr-programs/success-stories

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