The Center for Biologics Evaluation and Research (CBER) regulates biological products, including blood and blood products, blood derivatives, vaccines, allergenics, gene therapies, cellular therapies, and xenotransplantation, certain drug products, HIV test kits, medical devices involving blood and human cells and tissue products.
CBER is comprised of the Office of the Director and seven program offices. Three of the program offices are responsible for regulatory oversight of biological products—vaccines and allergenics; blood and blood products; and tissues and advanced therapies. The four remaining offices provide cross-cutting support in the areas of compliance; surveillance, epidemiology and biostatistics; communication, outreach and development; and management, budget and administrative services. The Office of the Director provides leadership and policy direction to the program offices and coordinates Center activities and resource management.
Meet Peter Marks MD, PhD, Center Director
Info on Vaccines, Blood & Biologics
Speakers:
Deirdre Hussey
Office of Management
Speakers:
Peter Marks, M.D., Ph.D.
Office of the Director
Speaker: John Swann, Ph.D.
Office of the Commissioner
Speaker: Irene Carroll
Office of Communication, Outreach and Development (OCOD)
Speakers:
Rondine Allen, Ph.D., Senior Biologist
Office of Therapeutic Products (OTP)
CDR Rod Barrais, D.H.S.c, Regulatory Officer
Office of Vaccines Research and Review (OVRR)
Cinque Soto, Ph.D., Lead Bioinformatics Reviewer
Office of Therapeutic Products (OTP)
Adam Spanier, M.D., Physician (Team Lead)
Office of Vaccines Research and Review (OVRR)
Speaker: Karen Donnelly, M.B.A.
Office of Talent Solutions
Speaker: LuDrean Peterson, M.S.M, M.B.A.
Office of Talent Solutions
Speaker: Deirdre Hussey
Office of Management