Shayne C. Gad

Shayne C. Gad, PhD, world-renowned KOL in the field of Nonclinical toxicology and safety, joined Olatec’s Drug Development Team in November 2011 and became a member of the Scientific Advisory Board in November 2012. Dr. Gad has been contributing leading expertise to the development of dapansutrile and the OLT Analogues in the design and conduct of Olatec’s Nonclinical program. Dr. Gad has over 38 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology and genotoxicology. Dr. Gad is the principal of Gad Consulting Services, a 23 year old consulting firm with 8 employees and more than 500 clients (including 120 pharmaceutical companies in the U.S. and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. Dr. Gad has direct involvement in the preparation of INDs (over 100 successfully to date), NDAs, PLAs, ANDAs, 510(k)s, IDEs, CTDs, clinical databases for Phase 1 and Phase 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the over 25 years. Dr. Gad has authored or edited more than 47 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He is a past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of Society of Toxicology’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. Dr. Gad received his BS from Whittier College in Chemistry and Biology and his PhD in Pharmacology/Toxicology at The University of Texas at Austin.