Speakers

Dr. Yan Wang is the Acting Deputy Director in the Division of Therapeutic Performance I (DTP-I), Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). DTP-I is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Dr. Yan has been at the U.S. Food and Drug Administration since 2013, serving in various roles, including as the subject matter expert in the area of complex long-acting drug products, and as the Team Lead for the Complex Drug Substance and Complex Formulation Team in ORS/DTP-1. In her current role, Dr. Yan leads a group of interdisciplinary scientists in the development of new analytical methods and equivalence evaluation methodologies for complex drug substances and parenteral, ophthalmic, otic, intrauterine, and intravaginal formulations. Yan has research interests in developing new analytical methods, in vitro characterization, and drug release testing methodologies for complex drug products. She specializes in complex parenteral, ophthalmic, otic, intravaginal, and intrauterine formulations.