Adam Fisher, PhD

Adam Fisher is the Director, Enterprise Project Staff in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. FDA, where he leads initiatives that advance pharmaceutical quality and manufacturing. Dr. Fisher chairs CDER’s Emerging Technology Program which provides FDA engagements on technical and regulatory issues for novel technologies prior to filing regulatory submissions. He previously created and led CDER’s Framework for Advanced Manufacturing Evaluation (FRAME) initiative which addresses the regulatory framework that supports the adoption of advanced manufacturing technologies. At FDA, Dr. Fisher has served as a primary and secondary reviewer of Abbreviated New Drug Applications (generics) and Drug Master Files, a Team Lead, a subject matter expert on complex drug substances and advanced biomanufacturing, and a liaison to the United States Pharmacopeia BIO1 Expert Committee. He joined the FDA in 2014 as a chemical engineer with expertise in the synthesis of biomolecules. Prior to joining FDA, Dr. Fisher’s work focused on the microbial production of proteins and glycoproteins. He was co-founder and Chief Science Officer of a startup company developing microbial technologies for producing glycoproteins. He earned his B.S. degree from the University of Maryland College Park (Chemical Engineering) and his Ph.D. from Cornell University (Chemical & Biomolecular Engineering).