CARE program: NCI and FDA interagency collaborations to support oncology small business entrepreneurs

Area of Science:

• Biomedical innovation
• Regulatory science
• Small business development

Background:

• National Cancer Institute's Small Business Innovation Research Development Center (NCI SBIR) funds over 300-400 small businesses annually for cancer technology commercialization.
• Small businesses often lack regulatory expertise, hindering the clinical translation of novel cancer technologies.
• Regulatory pathways present significant challenges for startups with limited resources.

Purpose of the Study:

• To introduce the Connecting Awardees with Regulatory Experts (CARE) program, a collaboration between NCI SBIR and the US Food and Drug Administration (FDA).
• To assess the impact of the CARE program on NCI-funded small businesses navigating early-stage product development and regulatory processes.
• To highlight NCI and FDA collaborations supporting early-stage oncology startups.

Main Methods:

• The CARE program connects NCI-funded small businesses with the FDA for regulatory feedback.
• A multipronged support approach includes education on FDA processes and resources.
• Participant feedback was collected through follow-up surveys.

Main Results:

• 141 companies have participated in the CARE program to date.
• 89% of participating companies reported guidance in planning regulatory steps.
• 81% received critical information that altered future NCI small business grant project aims.
• 90% of companies would recommend the program to others.

Conclusions:

• The CARE program effectively assists small businesses in navigating regulatory pathways for cancer technologies.
• Early-stage regulatory guidance significantly impacts technology development and future research directions.
• Interagency collaborations between NCI and FDA are vital for supporting the oncology startup community.