We are pleased to announce the addition of Timothy W. Robison, PhD, DABT, who has 29 years of experience at the US Food and Drug Administration 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. His expertise includes evaluation of inhalation, oral, and parenteral toxicology studies, genetic toxicity studies with drug candidates and impurities, and extractables and leachables studies with drug-device combination products. In addition, he was co-chair of the Center for Drug Evaluation and Research (CDER) Genetic Toxicity Subcommittee for 25 years, and in this role, provided recommendations on challenging genetic toxicology data. Dr. Robison leverages his extensive regulatory background to support nonclinical challenges at all stages of drug development. Together, our team of nonclinical safety experts offer end-to-end support to address your product development needs, from fit-for-purpose nonclinical testing strategies through protocol development, study oversight, and interpretation of study data, to risk management and regulatory interactions and submission support.
Dr. Robison is based in Oakland, CA, and can be reached by phone at 510-340-9142, or by e-mail at trobison@toxstrategies.com.