John Finkbohner, PhD AstraZeneca

Dr. Finkbohner joined the regulatory affairs department at MedImmune in 2006 and led the regulatory support efforts for investigational vaccine development for nearly six years. In early 2012, he transitioned to leading the Regulatory Policy and Intelligence function at MedImmune where he is responsible for driving regulatory policy development and advocacy in the US region in cooperation with key stakeholders across the Global Regulatory Affairs organization with particular focus on articulating a consolidated view on regulatory issues relevant to the biologics business. In this role he engages external trade organizations, such as BIO and PhRMA, and he led the regulatory team in developing MedImmune positions around PDUFA V reauthorization and served as an innovator industry representative during the BSUFA negotiations with the FDA. In the broader professional community, he is an adjunct on the graduate program faculty at Johns Hopkins University and serves on the Board of Directors for the Parenteral Drug Association (PDA) after being an active member for many years. In addition, he holds US certification from the Regulatory Affairs Professional Society (RAPS) and has presented at conferences, published articles, and contributed book chapters in the arena of biopharmaceutical and vaccine production.

Prior to joining MedImmune in May 2006, Dr. Finkbohner served in the FDA for 13 years as a CMC reviewer and establishment inspector with increasing levels of authority. His last position in FDA was with CBER as Deputy Director of the Division of Manufacturing and Product Quality with responsibilities in oversight of CMC and ED section reviews for BLAs, conduct of pre-approval inspections for biologics, the CBER lot release program, and policy development in the biologics manufacturing arena. Prior to joining the FDA, Dr. Finkbohner performed research in protein purification and characterization using both microbial and invertebrate model systems and held a faculty position with the University of Maryland, University College. Dr. Finkbohner received his bachelor's degree from the University of Central Florida, and both his masters and doctoral degrees from The Pennsylvania State University.