Cyrus Agarabi


CAPT Agarabi is a Laboratory Chief in CDER’s Office of Pharmaceutical Quality, Office of Biotechnology (OBP). He received his PharmD from the University of Rhode Island and continued on to receive his M.S. in Manufacturing Systems Engineering, as well as a MS & PhD in Pharmaceutical Sciences. Subsequently, he received his MBA at Georgetown University. Prior to Joining the FDA in ‘s Office of Testing and Research in 2009, he had industrial experience in biotechnology and small molecule pharmaceutical manufacturing. He joined OBP in 2015 as a Regulatory Research and Review Officer, where he was responsible for performing both primary and secondary regulatory review of biotechnology submissions and became a Principal Investigator studying upstream bioprocessing science. He is a member of the ICH Q13 Expert Working Group, CDER’s Emerging Technology Team and OPQ’s Manufacturing Science & Innovation Center of Excellence. During his nearly 12 years at FDA, he has coauthored over 50 peer reviewed publications, received Regulatory Science and Research (RSR), Critical Path (CP) and Medical Counter Measure (MCM) funding for competitive grant proposals for emerging technologies and bioprocessing. In addition, he has received several internal FDA and Public Health Service (PHS) awards related to regulatory review, laboratory science, and deployments for public health emergencies.