Paul Seo, Ph.D.
Director (Acting), Division of Biopharmaceutics
Office of New Drug Products
FDA, CDER, OPQ
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 and pre-formulation. Paul has worked for the FDA for over 12 years. Upon joining the Agency, he spent 5 years in the Office of Generic Drugs, where he served as bioequivalence team leader and dissolution specialist. After his time at OGD, he also served as the lead for the Compendial Operations and Standards and Technology Team in CDER in the Office of Pharmaceutical Science. In this capacity, he was responsible for overseeing all activities as they related to the United States Pharmacopeial Convention as well as other standards setting organizations. In 2014, Paul joined the Office of New Drug Quality Assessment as lead of the Biopharmaceutics Staff. With the reorganization to the Office of Pharmaceutical Quality, he is currently the acting Director of the Division of Biopharmaceutics in the Office of New Drug Products, and oversees the direction and review processes of both NDA and ANDA related Biopharmaceutics issues. Additionally, his professional experience included time at the National Institute of Standards and Technology, Shire Labs, Inc., and the Walter Reed Army Institute of Research.
The University of Texas at Austin College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
