Associate Director for Science&Biosimilar Strategy
OBP/OPQ/CDER/FDA
Joel Welch is the Associate Director for Science and Biosimilar Strategy 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) and the Chair of the Emerging Technology Team. Prior to his current role, he served as a Review Chief where he oversaw assessors who evaluate CMC information for monoclonal antibodies and therapeutic proteins. 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.
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Tuesday, September 13, 2022
4:35 PM – 5:30 PM MST