Thomas B. Smith, M.D., has joined Kendle as Global Medical Director. In this role, Dr. Smith will provide medical and therapeutic expertise to Phase I-IV clinical development projects and proposals for the company’s biopharmaceutical customers, with an emphasis on projects in the Central Nervous System (CNS) therapeutic area. Dr. Smith brings to Kendle significant experience in CNS drug development, having led a clinical team in the preparation and submission of an IND for a novel compound for Alzheimer’s disease. He also was involved in the successful filing of an sNDA of Depakote ER for bipolar mania. CNS is an important focus area for Kendle, with the company’s experience including more than 500 CNS projects in 53 countries involving nearly 110,000 patients.
“CNS now ranks as the second most researched therapeutic area worldwide in terms of drug development,” said Martha Feller, Ph.D., senior vice president, Global Clinical Development. “Dr. Smith’s expertise in this area will further strengthen our therapeutic experience in this significant and growing area of global clinical development.”
Dr. Smith brings nearly 20 years of pharmaceutical industry experience to Kendle. Serving most recently as senior director, Clinical Research and Development, Akros Pharma, he was responsible for assisting in the implementation and execution of clinical studies and for the preparation of clinical sections of regulatory submissions for new products and therapies. Prior to that, he served as medical director, Global R&D, Genzyme Corp., and associate medical director, Neuroscience Development, Abbott Laboratories. Dr. Smith’s background includes working across all phases of drug development and the full spectrum of therapeutic areas.