Patricia Hughes PhD U.S. FDA

Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently a Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently involved in developing and implementing policies for quality assessments of applications from a microbiology quality perspective and for pre-license inspections of biological product facilities. For more than ten years, she has led various teams/branches of reviewers/investigators responsible for microbiology product quality assessments of BLAs and for pre-license inspections of biological manufacturing facilities. Prior to joining the FDA, Dr. Hughes held various leadership positions in the biotech/pharmaceutical industry in areas of process development and in pharmaceutical operations. She has been with the FDA for over 20 years.