Case Name: Monique Aster, PhD
Background: With funding from an NIH SBIR grant, Monique has been using gene therapy to develop a treatment for a metabolic disease that runs in her family. She recently submitted her first Phase II annual report to Dr. Jane Stevens, her project officer at the NIH.
Jane Stevens <email@example.com>
I was excited to read about your progress in your first-year report for your Phase II SBIR grant.
It’s not too soon to think about Phase III development. The NIH has several programs that may be beneficial to support your commercialization and to get you to an inception point. The IIB Bridge award, for example, helps support the next phase of development after a Phase II SBIR award and commercialization.
If you haven’t looked into them, you should check out NCAT’s Therapeutics for Rare and Neglected Diseases (TRND) program. They support the preclinical development of therapeutic candidates for rare or neglected disorders. Another program, Bridging Interventional Development Gaps, supplies resources and offers consultation with intramural scientists to promising therapeutic candidates that might help you bridge the gap between SBIR funding and filing with the FDA. You may want to pursue them as you develop this treatment.
Let me know if you have any questions as you prepare your proposal.
Jane Stevens, PhD
SBIR Office NIH Agency
Other NIH Post-SBIR Commercialization Support
- Education Programs on Commercialization
- Concept to Clinic: Commercialization Innovation (C3i) Program – The C3i Program provides specialized business frameworks and essential tools for the successful early-stage translation of biomedical technologies from the lab (concept) to the market (clinical) to meet a need. The program guides investigators to better understand their innovation’s commercial viability through mentoring and a 24-week curriculum.
- Funding and Support Programs on Transitioning to the Marketplace
- Commercial Readiness Program (CRP) – This is an NIH program that supports the transition from Phase II to Phase III, that is, to go from being SBIR-funded to the marketplace. It provides training in developing tailored market entry strategies, building strategic partnerships, developing FDA regulator and reimbursement paths, creating financing strategies, and understanding intellectual property.
- NIH Innovator Support – A free business resource for small business awardees, NIH Innovator Support provides a team of entrepreneurs in residence assistance with the commercialization of their technology and achieving success in the market.
- NIH Partnering and Investment Opportunities – This provides information on partnering with the NIH. See FDA Technology Transfer for similar opportunities with the FDA.
- IIB Bridge Award: This award comes after an SBIR Phase II grant. It helps bridge the gap in funding between the SBIR program and commercialization. Funds help continue the development needed to bring the product to market, including technology validation and clinical translation. Funding is provided for two to three years. NCI IIB, NHLBI IIB, NSF IIB.