Shayne Gad, Ph.D., DABT

Director of Toxicology and Regulatory Affairs

Shayne Gad, Ph.D., DABT, is the Director of Toxicology and FDA Regulatory Affairs. Dr. Gad has extensive expertise in FDA regulatory affairs, pivotal as SRP-3D (DA) is advanced through the Phase 1 clinical trials into efficacy Phase 2 trials.  Dr. Gad has 48 years of experience in toxicology, drug development, and regulatory support to develop new molecules to FDA IND filings through clinical trials. To date, he has assisted 135 drugs through the development process to successful INDs and initiation of clinical trials, 6 NDA and numerous PLA, ANDA, 510(k), IDE, CTD, clinical databases for phase 1 and 2 studies, and PMAa. Dr. Gad has also authored several industry-standard guides on regulatory toxicology. He has worked with South Rampart Pharma since 2019 to develop the preclinical toxicology and genotoxicity studies of the novel non-narcotic analgesic, SRP-3D (DA).  Dr. Gad is past President of the American College of Toxicology (ACT), the Roundtable of Toxicology Consultants and three of Society of Toxicology’s (SOT) specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008. Dr. Gad is a current NIH study section member for small business commercialization grants and has acted as a grant reviewer for EPA, CAAT, NIH, and Canadian Health. His training includes active-duty service in the U.S. Navy and retired from the Navy reserves after 26 years of service. Dr. Gad did his undergraduate work in Whittier College (Chemistry and Biology) and received a Ph.D. in Pharmacology/Toxicology from the University of Texas at Austin. He is a Diplomate of the American Board of Toxicology.