Case Name: Monique Aster, PhD
Background: With funding from an NIH SBIR grant, Monique has been developing 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 see the progress you are making in your first-year SBIR Report from your Phase II project!
It’s not too soon to think about Phase III development. 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 preclinical development of therapeutic candidates for rare or neglected disorders. There’s another program, Bridging Interventional Development Gaps that supplies resources and consultation with intramural scientists to promising therapeutic candidates that might help you bridge the gap between SBIR funding and filing with the FDA. They might be something you may want to pursue 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
- Innovation Corps (I-Corps™) NIH or NSF program that “provides funding, mentoring, and networking opportunities to help commercialize” biomedical technology. The program is a 1 week immersive or longer program. Intended to support the transition to Phase III.
- Concept to Clinic: Commercialization Innovation (C3i) Program: The C3i Program provides specialized business frameworks and essential tools for successful early-stage translation of biomedical technologies from the lab (concept) to the market (clinical) to meet an unmet need. Investigators are guided to a better understanding of 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) is a NIH program that supports the transition from Phase II to Phase III, that is, to go from being SBIR-funded to the marketplace. Provides training in developing tailored market entry strategies, build strategic partnerships, develop FDA regulator and reimbursement paths, create financing strategies, and understand intellectual property.
- Regulatory and Business Development Associates, NIH Innovator Support – A free business resource for small business awardees. A team of entrepreneurs in residence provides assistance with commercialization of your technology and achieving success in the market.
- NIH Partnering and Investment Opportunities – Provides information on partnering with the NIH. See FDA Technology Transfer for similar opportunities with the FDA.