Professional Profile
Dr. Timothy Robison is a Senior Consultant in ToxStrategies’ Pharmaceuticals practice. He is a toxicologist with more than 39 years of experience in drug discovery and development, including close to 29 years at the U.S. Food and Drug Administration (FDA). He has nonclinical experience with biologic, biosimilar, and small-molecule products for a wide variety of pulmonary, allergy, autoimmune diseases, critical care, and transplant indications, as well as multiple routes of administration (e.g., inhalation, oral, intravenous, subcutaneous, intramuscular, intra-articular, and intranasal), in developing nonclinical sections (pharmacology, pharmacokinetics, toxicology) of regulatory documents (e.g., Interact, Pre-IND, IND, BLA/NDA), and regulatory agency interactions.
In the Center for Drug Evaluation and Research (CDER) at FDA, Dr. Robison served as a pharmacology/ toxicology supervisor/team leader and master reviewer in the Division of Pulmonary, Allergy, and Critical Care Products (DPACC) and Division of Rheumatology and Transplant Medicine (DRTM). As a supervisor, he was responsible for providing leadership and guidance to the Division’s team of pharmacology/ toxicology reviewers with respect to evaluating nonclinical data submitted in Interact, Pre-Investigational New Drug Applications (INDs), INDs, and New Drug Applications (NDAs)/Biologics License Applications (BLAs). He ensured that the team’s regulatory recommendations were scientifically sound and in line with applicable guidance documents. He also evaluated and presented recommendations on challenging scientific and regulatory issues to CDER senior management, including nonclinical hold deficiencies, complete responses to clinical holds, and other issues with the potential to influence clinical development.
Dr. Robison represented the Division’s nonclinical expertise at internal, industry, and Advisory Committee (AC) meetings, and provided recommendations to the Executive Carcinogenicity Assessment Committee (ECAC) on dose selection for rodent carcinogenicity studies and carcinogenicity study outcomes. In addition, Dr. Robison participated in Pharmacology and Toxicology Coordinating Committee (PTCC) meetings and interacted with other CDER review divisions to address cross-division review issues.
As a reviewer, Dr. Robison was responsible for reviewing nonclinical data packages. He prepared comprehensive written reports of nonclinical data, including inhalation toxicology data, and provided regulatory conclusions and recommendations including recommendations for approved product labeling. Dr. Robison also worked on multidisciplinary teams, addressed cross-discipline review issues (e.g., excipients, impurities, genotoxic impurities, and leachables), and participated in meetings with industry representatives to provide regulatory advice and guidance on nonclinical drug development programs.
A member of the CDER PTCC Genetic Toxicity Subcommittee from 2001 to 2025, Dr. Robison co-chaired the subcommittee from 2006 to 2025. He also served on the Expert Working Group for the ICH S2 (R1) Guidance from 2008 to 2012, and as an FDA representative to the Product Quality Research Institute’s initiative to develop thresholds for leachables in container closure devices used for parenteral drug products from 2013 to 2021. He was one of the organizers for two courses for manufacturing considerations and safety qualification of leachables (and extractables) from container closure devices used with parenteral drug products in 2015 and 2016. He was also one of the organizers of a working group in 2018 (and subsequently a subcommittee in 2019) for the safety qualification of extractables and leachables. This work culminated in a publication in 2021 on manufacturing considerations and safety qualification of leachables (and extractables) from container closure devices used with parenteral drug products.
Dr. Robison’s previous academic experience includes appointments as a Research Assistant Professor of Molecular Pharmacology and Toxicology in the Pediatrics Division of Neonatology at the Children’s Hospital of Los Angeles, and at the University of Southern California School of Pharmacy from 1986 to 1996.