Concept to Clinic: Commercializing Innovation (C3i) Program
The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.
The C3i Program is based on the Coulter Commercialization Process, an approach to biomedical research translation developed and continuously refined by the Wallace H. Coulter Foundation in collaboration with its academic partners across the country. Since 2001, the Foundation has supported more than 400 interdisciplinary teams of scientists and engineers, to bring the latest biomedical innovations to market for the benefit of human health and society at-large. To date, 82 projects have raised more than $2.2 billion in venture capital, 47 projects have been licensed to industry partners, and dozens more have received SBIR support. Most importantly, these efforts have given risen to more than 35 products, with 22 more advancing through Phase II or III clinical trials. The key features and elements which define the Coulter Commercialization Process have been captured and condensed into an intensive, fast-paced training course, the C3i Program.
In 2014, the NIBIB and the Coulter Foundation established a public-private partnership to offer the C3i curriculum to NIH-supported investigators. Over the past three years, three courses have been offered, providing mentored business training to 38 participating teams. Cumulatively, these teams have received over $12M in NIH SBIR/STTR grant funding and have raised over $32M in private equity financing, and one product has been cleared for marketing by the FDA.
Participants in the C3i Program will develop a comprehensive set of core skills that will enable them to: 1) evaluate whether or not a compelling unmet market need exists for their proposed solution, 2) assess whether there is a viable business opportunity that can be built to meet this need, and 3) build a compelling pitch presentation to secure support from potential investors and other business partners.
The selected C3i project teams will receive funding through administrative supplement awards to support participation in the program. To apply for an administrative supplement award, applicants must have received a prior grant under an eligible activity code from one of the participating ICs (please refer to Funding Opportunity below). The predicate grant must extend (at least) through March 30, 2018, and the grant should have remaining budget and R&D activities that extend at least until that date. Grant awards under a no-cost extension are eligible, provided they meet the above criteria.
Please refer to the current Funding Opportunity Announcement (PA-17-286) for further details: https://grants.nih.gov/grants/guide/pa-files/PA-17-286.html.