Speakers

Dr. Christopher Downey is the Director of the Division of Pharmaceutical Manufacturing Assessment VI in CDER/OPQ’s Office of Pharmaceutical Manufacturing Assessment (OPMA), a role he has held since May 2022. His division ensures product quality and sterility for CDER-regulated biologics by assessing microbiology controls and manufacturing data in BLAs, and leading pre-license inspections (PLIs) of manufacturing facilities. Previously, Dr. Downey was a Review Chief (2017–2022), Team Lead (2014–2017), and Reviewer (2012–2014) in the Office of Biotechnology Products. He holds a PhD in Biochemistry from the University of Colorado at Boulder and was a postdoctoral fellow at the University of Colorado and Georgetown University Medical Center.