Associate Director for Product Management
Center for Biologics Evaluation and Research, US FDA
Sheryl Lard-Whiteford, PhD, is the Associate Director for Product Management in the Center for Biologics Evaluation and Research (CBER) at the FDA. Dr. Lard has 34 years of experience at FDA, 11 in the Center for Drugs and 23 in CBER. She serves as CBER's Product Jurisdiction Officer, working closely with the Office of Combination Products and center counterparts to help ensure consistency and predictability in product jurisdiction decisions, generate guidance on product classification practices and address cross-center review issues. She also works within CBER on matters related to product classification, assignment and regulatory path considerations and serves as the CBER’s Ombudsman.
Prior to joining CBER, Dr. Lard-Whiteford was a microbiology reviewer and supervisor in the CDER Office of Drug Evaluation IV, where she earned the Master Reviewer designation for her work in HIV product development. She moved to CBER in 1999 following completion of FDA’s Leadership Development Program. Dr. Lard-Whiteford received a bachelor's degree in Microbiology from the University of Maryland, College Park and an MS and PhD in Microbiology and Immunology from Colorado State University (CSU) where her area of specialization was viral immunology. She completed a postdoctoral fellowship in tumor immunology in CSU’s Department of Pathology prior to joining FDA in 1987.
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Tuesday, September 13, 2022
3:30 PM – 4:30 PM MST