Policy Lead
US Food and Drug Administration, Invited
Silver Spring, Maryland
Paul received his BS in Biochemistry from the University of Maryland at College Park in 1999. Shortly thereafter, he received his Ph.D. in Pharmaceutical Sciences in 2004, from the University of Maryland, Baltimore, focusing in the area of biopharmaceutics. Paul has worked for the FDA for over 18 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, Office of New Drug Quality Assessment, Office of New Drug Products, and most recently in the Office of Clinical Pharmacology. He has served in various roles during his tenure at FDA, including OGD Team Leader, Standards and Compendial Operations Lead, Biopharmaceutics Division Director, and most recently OCP Policy Lead. He has helped develop numerous FDA guidances (e.g. BA/BE in NDAs and INDs, PBBM Guidance, BCS Guidance, BE with PK endpoints for ANDAs, dissolution testing of drug products containing high solubility drug substances, mechanical calibration of dissolution apparatus), and also served as the regulatory chair for the ICH M9 (BCS Based Biowaivers) Expert Working Group. Currently, he assists with the direction and policies of the Office of Clinical Pharmacology as they pertain to his field of expertise.
Disclosure information not submitted.
Monday, October 17, 2022
10:00 AM – 11:00 AM ET