Joel Welch, PhD

Joel Welch is the Associate Director for Biosimilar & Regulatory Policy (Acting) in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) revision to Q5A(R1). Prior to his current role, he served as a Review Chief where he oversaw as many as 20 assessors who evaluate CMC information for monoclonal antibodies and therapeutic proteins. In his time at FDA, he has worked as a regulatory project manager, a product quality reviewer, and a product quality/CMC team leader. He received a B.S. in Chemistry from the University of Kansas in 1999, and a Ph.D. in bioinorganic chemistry in 2004 from the University of Iowa. Prior to joining FDA in 2010, he spent six years in industry supporting late state analytical development of small molecules.