Shayne C. Gad, PhD, DABT, ATS
Adjunct Assistant ProfessorRegulatory and Quality Sciences
- Drug and device development
- Safety assessment
- Gad Consulting Services, CA
B.S. (Whittier College, Chemistry and Biology, 1971)
Ph.D. in Pharmacology/Toxicology (Texas, 1977)
Shayne C. Gad is Principal of Gad Consulting Services, a 24-year-old consulting firm with nine employees and more than 500 clients worldwide in the pharmaceutical and medical device industries. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008.
He served on Council, Membership, Program, and Animals in Research committees for ACT, multiple committees in SOT, and currently on the regulatory opinions committee of the Society of Toxicologic Pathologists, and previously at CMIR Chemical Hygiene Fellowship, Allied Chemical, Searle, Becton Dickinson and Synergen. He has authored or edited 49 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and device development and safety assessment.
He has more than 39 years of broad-based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment and genotoxicology. Grant reviewer for EPA, CAAT, NIH, and Canadian Health. He has direct involvement in the preparation of INDs (111 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. Served as the COO of two pharmaceutical companies while a consultant.