Joel T. Welch, PhD FDA

Joel Welch is a review chief in the Office of Biotechnology Products in the Center for Drug Evaluation and Research at FDA.   In this role, he oversees 12 reviewers who evaluate CMC information for monoclonal antibodies and therapeutic proteins from pre-clinical development through licensure, including both novel products and biosimilars.  Joel is a trained chemist, and spent six years in industry supporting late state analytical development of small molecules prior to joining FDA in 2010.   In his time at FDA, he has worked as a regulatory project manager, a product quality reviewer, and was most recently a product quality/CMC team leader.