Mike Lewandowski is a toxicologist turned entrepreneur with over 38 years of pharmaceutical development experience working with pharmaceutical companies and clinical research organizations to develop small and large molecule drugs. He is currently the Founding Principal and President of Global BioDevelopment, a consulting firm that specializes in pharmaceutical and medical device development services through strategic partnerships in the areas of manufacturing, formulation development, analytical and bio-analytical chemistry, pharmacology and toxicology, pharmacokinetics and drug metabolism, histopathology, experimental veterinary surgery, clinical pathology, regulatory affairs, and clinical affairs.
Mike’s experience includes creation of a histopathology company that has since been absorbed into a mid-sized CRO, serving as Director of Safety Evaluation at Scios, Inc., and Manager of Toxicology Studies at Genentech. While at Genentech, he was an important contributor for the preclinical development of several biotech drugs that ultimately made it to the marketplace. Mike started in the preclinical development business in 1975 with Baxter Laboratories, after graduating with a BS degree from Southern Illinois University.