Andrew C. Kolbert, Ph.D., M.T.M., President, has fourteen years of experience executing and managing programs from materials sourcing, formulation, and analytical development, through packaging development and manufacturing in the US, Europe, China, and India. His core expertise is analytical and structural chemistry, analysis of API and finished dosage forms, and CMC product development. He was recently the R&D Director of Velcera, a specialty pharmaceutical company where he directed all preclinical product development. At Cardinal Health, Pharmaceutical Technology and Services, he managed a structural and analytical chemistry business unit, which served pharmaceutical clients with a wide range of analytical, problem solving, and CMC development services. Previously at Honeywell, he worked as a Six Sigma green belt in process improvement saving millions of dollars in cost, increased throughput, and improved quality. Dr. Kolbert holds a Ph.D. in Chemical Physics from M.I.T., and a Masters in Technology Management from the Stevens Institute of Technology.

Advisory Board

James Lindsey, Ph.D., PMP, is President and founder of SciScout LLC, a life sciences consulting firm focused on providing toxicology and human health risk assessments of pharmaceutical and chemical products, chemical contaminants, materials and medical devices. Previously he was a Manager and Senior Scientist at Cardinal Health, where he implemented a "start-up" toxicology laboratory, providing in vitro drug discovery and literature-based toxicological human health risk assessment services. Dr. Lindsey was commissioned as a Naval officer and assigned to Naval Medical Research Institute Detachment – Toxicology, Wright-Patterson Air Force Base, where he developed a new microdialysis and neurobehavioral toxicity assessment laboratory and completed a series of programmed studies investigating neurotoxicity of compounds of military interest. Dr. Lindsey holds a Ph.D. in Chemistry from The University of North Carolina at Chapel Hill and a BS in Biochemistry from East Carolina University.

Charles Ye, MBA is CEO and founder of Acesys Pharmatech, a medicinal chemistry CRO in Nanjing, China. He founded Acesys Pharmatech in 2004 to serve the pharmaceutical community with custom synthesis and manufacturing, library design, exploratory medicinal chemistry, and co-development services. Mr. Ye comes from Schering-Plough Research Institute where he led a group of chemists to successfully complete the synthesis of the first large library synthesis at Schering-Plough. He has extensive experience on library design, process, and data analysis (both solution phase and solid phase). He is the inventor on patents in five different disease areas. Mr. Ye also serves as the Associate Director of Nanjing Association for Overseas Chinese Scholars (NAOCS) and Director of Pharmaceutical Institute of Nanjing Hi-Tech Zone.

Alan D. Hendricker Ph.D., is a Principal Scientist at Catalent Pharma Solutions. He has led numerous extractable and leachables programs for the pharmaceutical and device manufacturing industry. Dr. Hendricker was a member of the PQRI group formed for the development of safety thresholds and practices for extractables and leachables in orally inhaled and nasal drug products. He has managed materials characterization and trace organic analysis groups, specializing in mass spectral extractable/leachable profiling, and method development and validations of container-closure systems and device componentry, drug product packaging materials and drug substances for the pharmaceutical industry. Dr. Hendricker received his B.S. in Chemistry from Ohio University, and his Ph.D. in Chemistry from the Colorado School of Mines in Golden, Colorado.