US Food and Drug Administration
Silver Spring, Maryland
Andrew Babiskin, Ph.D. currently holds the position of Team Leader for the Locally-Acting Physiologically Based Pharmacokinetic Modeling Team in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs, CDER. His current work focuses on advancing mechanistic-based absorption modeling of local-acting complex products to develop/support novel in vitro and in vivo pharmacokinetic-based methods to establish bioequivalence in lieu of a bioequivalence study with clinical endpoints. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014.