TOXICOLOGY
PERSONAL PROFILE
- Board-certified toxicologist with 30+ years of research experience in toxicology.
- 20+ years experience in pharmaceutical drug development.
EXPERTISE
Regulatory/Biochemical Toxicology; Preclinical Toxicology Program Development; Lab Management/ Leadership; Global Submissions for Small Molecules and Biotherapeutics (INDs, NDAs, BLAs, CTDs ); Early/Late State Drug Development Oversight (new molecular entities, medical devices, reformulations of marketed products) Preclinical Safety Assessment Programs (toxicology, pathology, drug metabolism, pharmacokinetics/ toxicokinetics, bioanalytics); Risk Assessment Design/Analysis; Preclinical Regulatory Strategies; Global Drug Registration/Support; FDA/USDA Inspections; FDA, ICH, MHW, and OECD Regulations. Authored/co-authored 35 publications and 40 abstracts.
PROFESSIONAL EXPERIENCE
Vice President/Global Head, Drug Safety Evaluation, Preclinical Development, Vertex Pharmaceuticals, Inc.
Led day-to-day operations of Global Drug Safety Evaluation Department, responsible for preclinical safety assessments including toxicology, pathology, safety pharmacology, and discovery toxicology. Wrote INDs, NDAs, and other regulatory submissions; set policy and directed strategic planning for all non-clinical safety testing of new and marketed compounds at the Cambridge, San Diego, Laval (Canada), and Milton Park (UK) research sites. Managed regulatory interactions for preclinical safety issues, and developed and implemented the Global Drug Safety Evaluation Discovery Support Organization.
Senior Director, Toxicology/Pathology, Vertex Pharmaceuticals, Inc.
Reinvented, optimized, and led the Toxicology Group. Grew the Safety Pharmacology and pathology groups into the Drug Safety Evaluation Department. Provided internal and outsourced toxicology studies, formulated and implemented preferred provider agreements, and was responsible for all FDA and worldwide regulatory interactions involving preclinical safety issues.
Vice President/Global Head, Academic Alliances, External Relations, and Scientific Advice, Global Non-Clinical Safety, Hoffmann La-Roche
Responsible for preclinical safety assessment, including toxicology, pathology, drug metabolism, bioanalytics, and pharmacokinetics/toxicokinetics. Set policy and directed strategic planning for all non-clinical safety testing of new and marketed products, led day-to-day operations, set safety standards and assessments of potential new molecular entities, and managed study outsourcing activities. Provided advice to global drug development teams and assessed acceptability of new submissions to worldwide health authorities. Guided global drug development teams on strategies, problem resolution, and health authority requests (i.e., Taspoglutide). Coordinated preclinical development activities for therapeutic stem cell therapy program and developed strategy for sustainable nonclinical Safety Capacity in Africa with WHO.
Vice President/Senior Safety Advisor/Head, External Relations, Global NonClinical Safety, Hoffman La-Roche
Provided advice, feedback, and support to head of Global Safety, and regulatory advice to early- and late- stage projects. Advised drug development teams and assessed acceptability of new submissions to FDA. Interacted with US DRA to preview submissions, acted as mock FDA reviewer, and provided nonclinical advice. Guided drug development teams on strategies, problem resolution, and health authority requests. Developed and implemented cohesive CRO strategy and established partnership.
Executive Director, Nonclinical Drug Safety Evaluation/Pharmacokinetics Drug Metabolism, Purdue Pharma
Led Preclinical Development. Provided oversight of all biology functions and development activities required for the successful submission of dossiers for new and reformulated products. Enhanced interactions with Discovery Research to better select development candidates.