Kenneth J. Olivier Jr., Phd
Drug Development Expert , Instructor
Nonclinical Development
Biotech Primer
United States of America
Biography
Kenneth J. Olivier Jr., PhD, has been developing drugs for 15 years and is currently Head of Nonclinical Development at Acceleron (XLRN) Pharmaceuticals in Cambridge, MA. Dr. Olivier’s work experience includes biotechnology and pharmaceutical companies, spending time at Regeneron, Biogen, GlaxoSmithKline, and Merrimack Pharmaceuticals developing diagnostics, small molecule drugs, and biologics for indications in cardiology, neurology, neuromuscular, immunology, rare disease, infectious disease, fibrosis and oncology. Though his primary duties have been safety evaluations, Dr. Olivier has held the role of Project Leader, Head of Project Management, Head of Regulatory, Head of Pharmacokinetics, Head of Bioanalytical Development, Validation and Sample Analysis and Head of Nonclinical supporting multiple INDs, IMPDs, CTAs, NDAs, BLAs, PLEs and IDEs. In addition, Dr. Olivier is an adjunct faculty member at Oklahoma State University and has taught drug development courses at Harvard, MIT and through the American College of Toxicology, for which he is currently serving on the Editorial Board (International Journal of Toxicology) and as an elected Council Member. Just 2 years ago, he created what is currently the Oklahoma State graduate course on drug development attended largely by faculty, medical and veterinary students. Dr. Olivier has spent the past 9 years training CSOs, CEOs, CMOs, Project Team Leaders, Functional Heads and Team members on how to transition from discovery to development to market approval (within private and public companies), covering all topics related to drug development. Dr. Olivier has chaired/co-chaired/presented symposia and taught drug development annually over the past 14 years, covering all areas and specific topics such as safety pharmacology, stem cells, computational modeling, antibody-drug conjugates, and the art of clinical dose level selection. In addition to teaching and developing much needed diagnostics/devices/therapies, Ken enjoys participating on Scientific Advisory Boards, including a DARPA funded project at MIT and a start-up company in San Francisco. Dr. Olivier’s publications include evaluations of toxicity related to novel therapeutics in immunology and oncology, such as interferons, bispecific antibodies, targeted liposomal nanotherapies and Intellitrap® technology. Most recently (2016), he published a book on the development of ADCs covering chapters from discovery through post-market approvals with topics spanning all aspects of drug development, including CMC, Nonclinical, Regulatory and Clinical strategies. Dr. Olivier obtained a BS in Toxicology from the University of Louisiana at Monroe and a PhD in Veterinary Biomedical Sciences from Oklahoma State University.
Research Interest
Healthcare, Pharmaceutical Sciences