Tim Robison, PhD, DABT

SENIOR CONSULTANT, NONCLINICAL TOXICOLOGY
ToxStrategies

I have 40 years of experience as a nonclinical toxicologist with 29 years at the US FDA as a Reviewer, Team Leader, and Supervisor working with multidisciplinary teams to support development of drugs for pulmonary, allergy, critical care, autoimmune, transplant, and viral (e.g., COVID) indications. My expertise includes evaluation of inhalation, oral, and parenteral toxicology studies, genetic toxicity studies with drug candidates and impurities, and extractables and leachables studies with devices used for pulmonary and autoimmune indications. In addition, I was co-chair of the CDER Genetic Toxicity Subcommittee for 25 years, and in this role, I provided recommendations on challenging genetic toxicology data. I leverage my extensive regulatory background to support nonclinical challenges at all stages of drug development for many different indications.