Dr. Timothy McGovern is co-founder and a Principal Consultant at White Oak Regulatory Tox, LLC where he provides regulatory advice and nonclinical support for all aspects of nonclinical drug development. He is also a Past President of the American College of Toxicology, a Councilor for the Society of Toxicology Regulatory and Safety Evaluation Specialty Section (RSESS) and a recipient of the 2024 RSESS Outstanding Contribution to Regulatory and Safety Evaluation Award.
Dr. McGovern has over 22 years of regulatory experience at the US Food and Drug Administration (FDA). Most recently, he served as an Associate Director for Pharmacology and Toxicology in the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER). In this role, he was a member of the Pharmacology/Toxicology Senior Leadership Team within OND and a standing member of CDER’s Executive Carcinogenicity Assessment Committee. Dr. McGovern was active in policy and guidance development on nonclinical and regulatory issues including FDA and International Council for Harmonization (ICH) initiatives and provided tertiary review for New Drug and Biologics License Applications (NDAs and BLAs). He was a member of the ICH Expert Working Groups for the S1B (Testing for Carcinogenicity of Pharmaceuticals), Q3C (Residual Solvents), Q3D (Elemental Impurities) and M7 (DNA reactive impurities), also serving as Rapporteur for the former three EWGs. Dr. McGovern also served as a member of CDER’s Task Force on Nitrosamines in Drug Products and chaired CDER’s Pharm/Tox Nitrosamines Working Group, providing nonclinical expertise in developing policies, addressing clinical safety issues, and interacting with other Drug Regulatory Agencies and industry representatives. He participated in the development of FDA’s Guidances “Control of Nitrosamine Impurities in Human Drugs” and “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)”. He was also Chair of CDER’s Genetic Toxicology and Pharm/Tox Education Subcommittees.
Dr. McGovern was trained in the field of inhalation toxicology and began his career at the FDA as a reviewer in the Division of Pulmonary and Allergy Products and then Supervisor in that division as well as the Division of Anesthetic, Critical Care and Addiction Products. His responsibilities included evaluating nonclinical development programs supporting Investigational New Drug (IND) applications in support of clinical development, as well as NDAs and BLAs, and providing recommendations on the safe conduct of clinical trials and eventual marketing approval and labeling. During this time, he represented FDA on a multistakeholder effort in developing consensus recommendations on the safety qualification of extractables and leachables in orally inhaled and nasal drug products.
Between two tenures at FDA, Dr. McGovern was a Managing Consultant at SciLucent, LLC where he provided regulatory and scientific consulting services to the healthcare product industry. He specialized in developing nonclinical testing strategies and evaluating data for small molecule pharmaceuticals, biologics, biosimilars, and medical devices as well as resolving issues related to the safety qualification of genotoxic impurities, metabolites, and product-related leachables. During this time, he also served as a member of the US Pharmacopeia Expert Toxicology Committee.
Dr. Todd Bourcier is a regulatory pharmacologist with over 25 years of experience in nonclinical drug development, regulatory science, and translational research. He is the co-founder and principal consultant at White Oak Regulatory Tox, LLC, where he advises pharmaceutical and biotechnology companies on designing and executing nonclinical development strategies that align with U.S. and international regulatory expectations. His consulting expertise spans small molecule and biologic programs, with a focus on cardiovascular, endocrine, and hematologic indications.
Prior to founding White Oak Regulatory Tox, Dr. Bourcier held several leadership roles at the U.S. Food and Drug Administration (FDA), most recently serving as Director of the Division of Pharmacology and Toxicology in the Office of New Drugs (CDER/OCHEN). In this role, he led a multidisciplinary team of 45 scientists and played a pivotal role in shaping nonclinical regulatory policy, refining review processes, and advancing regulatory science initiatives. He provided tertiary review and final regulatory recommendations for high-impact investigational and marketing applications and was instrumental in resolving complex development challenges across therapeutic areas.
Dr. Bourcier was a core member of the FDA’s Senior Leadership Team for pharmacology and toxicology and served as the FDA topic lead to the ICH S1B(R1) Expert Working Group, which developed a weight-of-evidence framework to modernize carcinogenicity assessment. His work has directly influenced international guidance and supported the integration of new approach methodologies (NAMs) into regulatory practice. He also collaborated with the Health and Environmental Sciences Institute and contributed to FDA-industry initiatives aimed at reducing reliance on animal testing while maintaining safety standards.
Before his tenure as Division Director, Dr. Bourcier served as a Supervisory Pharmacologist and Primary Reviewer at FDA, where he led teams evaluating nonclinical safety data supporting INDs, NDAs, and BLAs. He has contributed to advisory committee briefings, agency policy committees, and scientific publications addressing regulatory toxicology and drug safety evaluation. His expertise is especially deep in carcinogenicity risk assessment, where he has led initiatives examining molecular and epigenetic mechanisms, including studies on lorcaserin-associated tumorigenicity.
Dr. Bourcier earned his Ph.D. in Pharmacology from New York Medical College and conducted postdoctoral research at Brigham and Women’s Hospital and Harvard Medical School, where his work focused on inflammatory and vascular mechanisms of cardiac injury. He has authored numerous peer-reviewed articles, book chapters, and regulatory reports, and has received FDA and CDER honors, including the Frances O. Kelsey Drug Safety Excellence Award.