Dr. Kanekal is a board-certified regulatory professional and a board-certified toxicologist with 23-years of pharmacology and toxicology industry experience. He is a veterinarian and holds a PhD in Pharmacology and Toxicology from the University of California, Davis and has conducted post-doctoral research at the College of Pharmacy, University of Texas at Austin. He is an industry veteran in regulatory strategy and safety assessment of small molecules and biologics, of both new molecular entities and reformulated drugs.
Dr. Kanekal has a track record of advancing drugs through their entire life cycle from preclinical to clinical proof-of-concept, clinical development, and regulatory filings. He has managed regulatory and non-clinical safety programs for several small molecule drugs and biologics and was responsible for over 40 IND/NDA/BLA approvals. His successes include over 15 marketed cancer drugs such as tositumomab (Bexxarâ) (anti-CD20 Ab), bendamustine (Treandaâ), omacetaxine mepesuccinate (Synriboâ) for various indications. Dr. Kanekal held leadership positions with Novartis (Chiron), GlaxoSmithKlein (Corixa), Teva Pharmaceutical Industries (Cephalon, Salmedix, ChemGenex), Astex Pharmaceuticals (SuperGen), Absorption Systems, Reviva, Apollomics, and Seneca Therapeutics.