Sean Kassim, PhD

Director, Office of Study Integrity and Surveillance, OTS, CDER

Dr. Kassim is the director of the Office of Study Integrity and Surveillance (OSIS) in the Office of Translational Sciences (OTS) in FDA’s Center for Drugs (CDER). OSIS oversees the conduct of bioavailability and bioequivalence (BA/BE) and Good Laboratory Practice (GLP) studies in support of pharmaceutical development, as part of FDA’s Bioresearch Monitoring (BIMO) program.

Previously, Sean served as the director of the Office of Scientific Investigations (OSI), in CDER’s Office of Compliance, overseeing compliance programs and enforcement for pharmaceutical BIMO (GCP, IRB) and post-market reporting (PADE, REMS, PMR) activities. He started at FDA as a reviewer for the BE/GLP compliance program in OSI’s predecessor, the Division of Scientific Investigations.

Before coming to FDA, Sean worked at the University of Washington in Seattle. Sean received his doctorate from Washington University in St. Louis and his undergraduate degree from the University of Maryland Baltimore County.

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