Regulatory Science Collaboration
The Business Committee on Regulatory Science (BCRS) identified opportunities for broader collaboration and information sharing, particularly regarding funding opportunities for regulatory science research projects. As a result, the BCRS recommends that:
- The NC Biotechnology Center establish a regulatory science intellectual exchange group to support information sharing and other interactions among interested businesses and academic institutions. This group should:
(1) Invite presentations from FDA officials and existing FDA-sponsored Centers of Excellence in Regulatory Science and Innovation (CERSI) in other states. Identifying areas of focus at FDA and in other states could indicate if there is a niche that would align with North Carolina’s assets and could serve as the foundation for building a regulatory science program in North Carolina.
(2) Monitor the potential for developing more formalized structures among institutions to apply for grants and other funding opportunities.
(3) Determine ways to integrate industry into regulatory science-related academic and other non-profit programs.
(4) Monitor FDA Broad Agency Announcements and Requests for Proposals for funding opportunities personalized medicine, (5) Develop a process for keeping the BCRS members informed about activities of the group.
- The NC Biotechnology Center integrate regulatory science into its life science brand for North Carolina.
- NCBIO create a forum for CROs to exchange ideas on policies, education, best practices and other areas of interest, especially in the realm of regulatory science.