Back to: BsUFA III Regulatory Science Pilot Program: Progress Update
Presenter
Kimberly Maxfield, PhD
Pharmacologist
BsUFA Reg Sci Lead
Office of Therapeutic Biologics and Biosimilars (OTBB)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Kimberly Maxfield, the scientific lead of the Regulatory Science Pilot Program for BsUFA III, presents updates on the program’s research portfolio. The program utilizes revised research priorities published in January 2024 to guide and evaluate its work. As of January 2025, the program has completed six funding cycles (three external, three internal), which are strategically “front-loaded” to allow research maturation. These cycles have resulted in awards for 19 projects across five of the six research priorities, with a strong focus on priority D, which addresses alternatives to comparative immunogenicity assessment. Detailed information on each project and its progress is accessible on a redesigned FDA webpage with a dedicated awards section. Currently, the program is conducting open funding cycles for FY25 (external) and FY26 (internal), which are focused on priority F, the only priority without funded projects. An amendment related to priority F was added to the external Broad Agency Announcement, which closes on February 24, 2025.