Sarath Kanekal

Dr. Kanekal is a board-certified Regulatory Professional and board-certified Toxicologist with 21-years of biotech pharmaceutical industry experience. He is a veterinarian and has a Ph.D. in Pharmacology and Toxicology from the University of California at Davis and has conducted post-doctoral research at the School of Pharmacy at University of Texas in Austin. Dr. Kanekal is an expert in regulatory strategy and safety assessment of small molecules and biologics for both new molecular entities (NCE) and reformulated drugs. He has a track record of rapidly moving early-stage drugs into clinical development and eventual NDA. He has managed non-clinical safety programs for several drugs was responsible for over 30 IND/NDA/BLA approvals, including over 15 cancer pharmaceuticals such as Bexxar (anti-CD20 Ab), Treanda, Synribo and Dacogen. He has conducted several meetings with FDA and participated in oncology advisory committee meetings (ODAC). He is currently president of Regstrategy Consultancy and provides counsel to start-ups on non-clinical development and regulatory affairs. He previously held leadership positions with numerous pharmaceutical companies including Novartis (Chiron), GSK (Corixa), Teva (Cephalon, Salmedix, Chemgenex), and Astex (Supergen).