More Than Money: NCI and FDA Partnership Provides Regulatory Assistance to Oncology Startups

Author: Monique Pond, PhD on April 27, 2023


Federal funding is great, but it takes more than money to translate innovative research ideas into the clinic where they can impact public health. The National Cancer Institute's Small Business Innovation Research Development Center (NCI SBIR) supports the commercialization of novel cancer-related technologies by providing ~$200M in non-dilutive funding to small businesses each year; however, NCI SBIR also provides other resources that are critical for technology development such as entrepreneurial training, access to investor networks, and recently, regulatory assistance in collaboration with the US Food and Drug Administration (FDA).

The FDA and NCI SBIR developed an interagency regulatory assistance program called CARE – Connecting Awardees with Regulatory Experts. The CARE program provides small businesses with coordinated support from the FDA and NCI to facilitate innovative, safe, and effective technologies in reaching patients. For example, a point of uncertainty for many medical device companies is the appropriate regulatory submission pathway for their technology (e.g., De Novo, Premarket Notification 510(k), Premarket Approval). As part of CARE, a device company was able to discuss their future regulatory path with the FDA, which informed the company’s next preclinical steps. In addition, the interagency CARE partnership provides a model for developing future impactful interagency collaborations in other areas of mutual priority.

The authors discuss the development of the CARE program and share outcomes in a recent paper published in Clinical and Translational Science. To date, 141 companies have participated in the program. Follow-up surveys from 2020-2022 found that the program helped companies learn or identify the FDA Center that will regulate their technology (97%) and plan the next regulatory steps for their technology development (89%). As part of the program, companies reported they received critical information that changed their future NCI small business grant project aims (81%), suggesting future grant applications will better align with FDA requirements. Overall, 90% of companies would recommend the program to other companies.

Learn more here about how NCI can help small businesses that are developing innovative cancer technologies cross the “Valley of Death” and reach commercialization. print
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