Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presenter
Robert Lionberger, PhD
Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Robert Lionberger, PhD serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments, including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product-specific guidances, and correspondence responses.
He received his undergraduate degree in Chemical Engineering from Stanford University and a Ph.D. in Chemical Engineering from Princeton University. After receiving his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the U.S. Food and Drug Administration 18 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.