Charles F. Jewell

FDA/CDER/OPQ/ONDP
Acting Branch Chief
Chuck Jewell is the acting branch chief in FDA’s Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/New Drugs Active Pharmaceutical Ingredients Branch 1, where he supervises 12 new drug API reviewers. He received his Bachelor’s Degree in Chemistry from Rice University in 1979 and his Ph.D. in Chemistry from Emory University in 1986 (Under Professor Lanny S. Liebeskind; Organometallic Chemistry). After a career in new drug discovery at Novartis Pharmaceuticals (19+ years), Biogen (3 years) and Avila Therapeutics (1 year) he joined the FDA in October of 2008 as a CMC reviewer for new drugs. Chuck is serving on the ICH Q11 Implementation Working Group (IWG) tasked with the development of the Q11 Q&A Guideline on the selection of starting materials in the manufacture of drug substances, where he represents the FDA as a deputy leader. Currently he is leading a sub-team of this IWG in the development for training materials for the new ICH Q11 Q&A Guideline, targeted for publication on the ICH website.