Associate Director for Biosimilars and Therapeutic Biologics
US FDA, CDER., Office of Clinical Pharmacology, Maryland
Dr. Wang is the Associate Director for Biosimilars and Therapeutic Biologics in the Office of Clinical Pharmacology (OCP) of CDER, FDA. She leads the Therapeutic Biologics Program in the Immediate Office of OCP; the team has a mission to promote scientific and regulatory excellence in biologic product development through developing clear policies, enhancing excellence in review, facilitating knowledge sharing, and building collaboration & outreach. Since joining FDA in March 2011, she has led and contributed to various projects that aim to develop evidence-based approach to inform regulatory review practice. These biologics and biosimilars related projects cover a wide range of topics, e.g., utility of PD biomarkers in biosimilar development, bridging approaches for biologics-device combination products and routes of administration, evaluation of clinical impact of immunogenicity, bioanalytical methods, etc. Prior to joining the FDA, she worked in the pharmaceutical industry for 18 years with experience in small molecules and large molecules. She received her PhD degree from The Ohio State University College of Pharmacy with a research focus on Pharmacokinetics and Biopharmaceutics.
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