Co-Director, Therapeutic Biologics Program
US Food & Drug Administration CDER/OTS/OCP/IO
Dr. Sarah Schrieber, PharmD is Co-Director of the Therapeutic Biologics Program in the Immediate Office of the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She received a Bachelors in Cell and Molecular Biology from Missouri State University, and a Bachelors in Pharmacy and Pharm.D. from Saint Louis College of Pharmacy. She completed a general pharmacy practice residency at Cox Health Systems in Springfield, MO, followed by a postdoctoral fellowship in drug development at the University of North Carolina at Chapel Hill and United Therapeutics Corp. Previously, as a senior clinical pharmacologist and biosimilar lead in Division V within OCP, she reviewed numerous small molecule and biologic hematology/oncology products. Some current topics of interest include regulatory policy development for biosimilars, evaluation of PD markers for biosimilars, and understanding the impact of PEGylation on biosimilarity assessment. Dr. Schrieber is committed to advancing public health through innovation of regulatory science.
Tuesday, November 6
9:00 AM – 9:30 AM