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Dr. Carver is a regulatory expert consultant with over 20 years of experience in biologic and drug R&D and manufacturing, from early development to the post approval phase of commercial products. He advises companies on requirements for obtaining approval of a wide range of biologics and drugs, including many types of protein therapeutics, and he has supported recent submissions for a number of biosimilar products. Prior to joining PAREXEL 6 years ago, Dr.Carver was a senior review chemist at the U.S. FDA and held several positions in various companies such as Johnson & Johnson PRD and 3-Dimensional Pharmaceuticals.