Adam Fisher, PhD

Adam Fisher, PhD is the Director of Enterprise Project Staff in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER). He is the lead of CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative to support the adoption of advanced manufacturing technologies that could bring benefits to patients. He has been a super-office associate director, primary and secondary reviewer of drug applications and Drug Master Files, team lead, subject matter expert on complex drug substances and advanced biomanufacturing, and liaison to the US Pharmacopeia BIO1 Expert Committee. He joined FDA in 2014 as a chemical engineer with expertise in the synthesis of biomolecules. Prior to FDA, he was co-founder and chief science officer of a biotechnology startup company. He earned a BS degree in chemical engineering at the University of Maryland College Park and a PhD in chemical and biomolecular engineering at Cornell University.