Michael J. Whitekus, Ph.D., DABT

Michael J. Whitekus Ph.D., DABT

Toxicologist & Drug Safety Expert

Dr. Michael Whitekus is a toxicologist with expertise and experience in the fields of drug safety, blood alcohol concentration analysis, inhalation toxicology, chemistry, and environmental contaminants. Dr. Whitekus applies his expertise in toxicology towards causation analysis, resolving disputes relating to adverse drug and alcohol events, and exposure to chemical and environmental toxins.

Dr. Whitekus has held various key toxicology positions in industry, most recently working at Pfizer, Inc. as a drug safety team lead and senior study director. As a drug safety expert Dr. Whitekus has authored or reviewed ~180 drug safety reports, authored or contributed to FDA investigational new drug applications and new drug applications (INDs/NDAs), and has evaluated numerous drugs (e.g., Lyrica® and Milnacipran®) in multiple therapeutic areas including allergy, vaccine development, infectious disease, oncology, the central nervous system, the cardiovascular system, metabolic disease (diabetes), and inflammation. As a study director Dr. Whitekus oversaw laboratory operations for the drugs he evaluated. Prior to working at Pfizer, Dr. Whitekus was a laboratory director at BioReliance and provided leadership critical to drug safety evaluation and oversaw laboratory operations for the drugs he evaluated. Dr. Whitekus completed postdoctoral training at the UCLA School of Medicine’s Clinical Immunology and Allergy department in conjunction with the Southern California Particle Center and Supersite.

Dr. Whitekus received his undergraduate degree in chemistry and a Michigan provisional secondary teaching certificate (Chemistry/Math) from Eastern Michigan University (EMU). He then was awarded an MS degree in Chemistry from EMU and a PhD degree in molecular and cellular toxicology from Wayne State University. Dr. Whitekus is a graduate of the Borkenstein course on Alcohol and Highway Safety and is a member of both the Society of Toxicology and the American College of Toxicologists.

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