Speakers

Christopher (Chris) Downey is the Director of the Division of Biotechnology Manufacturing Assessment in FDA/CDER’s Office of Pharmaceutical Manufacturing Assessment (OPMA), serving in this role since May 2022. His division is responsible for assessing CMC information related to microbiology and to manufacturing and testing facilities, including conducting pre-license inspections (PLI) for CDER-regulated biologics, both original applications and biosimilars. Prior to joining OPMA, he served in FDA/CDER’s Office of Biotechnology Products from 2012 – 2022, where he led application review teams and managed technical staff in the assessment CMC information related to product quality for CDER-regulated biologics. Dr. Downey holds a PhD in Biochemistry from the University of Colorado at Boulder was postdoctoral fellow at the University of Colorado and Georgetown University Medical Center.