Dr. Lionberger is from the Office of Generic Drugs at the FDA. He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering, working on modeling the rheology of colloidal suspensions. After his PhD, he spent two years of post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA, he was an Assistant Professor of Chemical Engineering at the University of Michigan where he was involved in the development of a new Pharmaceutical Engineering program. At the FDA, his activities include the development of bioequivalence methods for locally acting drugs, mathematical modeling of drug dissolution and absorption, and incorporation of product and process development information into the ANDA CMC review process through a question-based review. He was closely involved in the development of FDA’s critical path initiative for generic drugs.