Lex Smith is an independent consultant working in all areas of CMC product development. Mr. Smith holds a total of 35 years of experience in the pharmaceutical industry, working with both small and large pharma companies, including Burroughs Wellcome/GlaxoWellcome, UCB Pharma, Serenex, Inc., Viamet Pharmaceuticals, Fulcrum Pharma Developments and G1 Therapeutics. Lex has significant pharmaceutical development experience with solid dosage forms, instant and modified release, and parenteral dosage forms. Mr. Smith received a Bachelor of Science in Chemistry from UNC-CH and an MS in Pharmaceutical Chemistry from Lehigh University.

Over his career, Lex held positions of increasing responsibility in Pharmaceutical/Chemical Development, CMC Regulatory Affairs, and CMC project management. Previous roles include vice-president level positions in four companies, most recently, VP – Technical Operations for G1 Therapeutics with responsibility of drug substance and drug product development for three clinical stage compounds. Lex provided major scientific contributions for over 125 INDs and over 10 NDAs including Zyban® SR Tablets, Valtrex®Tablets, Retrovir® Capsules, Emtriva® Capsules, Keppra®Tablets and Trilaciclib Sterile Powder submitted June 2020. Additional experience includes GMP auditing and the preparation of Drug Master Files.