Charles "Charlie" DiLiberti
President, Montclair Bioequivalence Services, LLC
Charlie DiLiberti has over 40 years’ experience in the pharmaceutical industry, much of which (17 years) was at Barr Laboratories (later acquired by Teva Pharmaceuticals). Charlie built and oversaw Barr’s cutting-edge bioequivalence and pharmacokinetics program for generic drugs, small molecule proprietary drugs, and biologics. Charlie left his position as Vice President of Biopharmaceutics at Teva Women’s Health Research in 2010 to start his own firm, Montclair Bioequivalence Services, LLC, which provides strategic consulting services around the world in generic, innovative, and biological drug development, biostudy planning/risk management, formulation development guidance, and advanced troubleshooting methods, with a focus on difficult/complex products. Charlie has given numerous public presentations, in the US and internationally, on a wide variety of topics, including pharmacokinetics, bioequivalence, BCS waivers, biosimilars, highly variable drugs, narrow therapeutic index drugs, complex drugs, locally-acting drugs, adaptive sequential bioequivalence designs, analytical chemistry, physicochemical characterization of biological products, generic drug development, etc. In 2018, along with several colleagues, Charlie co-founded Scientists Advancing Affordable Medicines, Inc. (SAAMnow). Charlie holds a BA in Biochemical Sciences from Princeton University and an MS in Chemistry from Stevens Institute of Technology.