John Finkbohner, Ph.D.
Dr. Finkbohner joined the regulatory affairs department at MedImmune in May 2006. In the broader professional community, he is an adjunct on the graduate program faculty at Johns Hopkins University and is an active member of the Parenteral Drug Association (PDA) and Regulatory Affairs Professional Society (RAPS). In addition, he has presented at conferences, published articles, and contributed book chapters in the arena of biopharmaceutical and vaccine production. Since 2014, he leads global regulatory policy position development and advocacy around biosimilar products, and contributes to regulatory policy development and engagement in the US region in cooperation with key stakeholders across the AstraZeneca and MedImmune organizations, and leads the development and articulation of MedImmune’s and AstraZeneca’s consolidated view on key FDA regulatory guidances and regulations that are relevant to the biologics business.
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.