Head of Toxicology
Ken Olivier, PHD
Kenneth J. Olivier Jr., PhD, is the Head of Toxicology at Asalyxa Bio. He has been developing drugs for over 16 years and is President and sole proprietor of Olivier KOnsulting since inception on 02SEP2015. Ken is also an Instructor for Biotech Primer teaching customized drug discovery, development and commercialization courses to biotechnology and pharmaceutical industry professionals. Dr. Olivier’s work experience includes biotechnology and pharmaceutical companies, spending time at Regeneron, Biogen, GlaxoSmithKline, Merrimack Pharmaceuticals, Acceleron Pharma, Torque Therapeutics and Morphic Therapeutic developing small molecule drugs, biologics, diagnostics, antibody drug conjugates, antibody directed nanotherapies and cell based therapies for indications in cardiology, neurology, metabolic disease, neuromuscular disease, 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 formerly as an elected Council Member. Just 4 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 12 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 and is currently and Instructor for Biotech Primer, Inc. 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, Statistics, 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 Cytokine trap technology.
In 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.