Pharmaceutical company BioDelivery Sciences International (BDSI), headquartered in Raleigh, N.C., has hired Adrian Hepner, M.D., Ph.D., as vice president of clinical research and regulatory affairs. Hepner joins BDSI with over 20 years of experience in U.S. and international clinical research and drug development, including development and implementation of the clinical and regulatory strategy for a number of products from early stage development through NDA and E.U. regulatory filings.
Hepner's pharmaceutical industry experience includes over 12 years of progressively increasing drug development responsibilities, including a role in the regulatory and clinical activities for FDA approval of the first product for Pseudobulbar Affect and successfully completing placebo-controlled studies in painful diabetic neuropathy. Most recently, Hepner was senior medical director at UCB BioSciences, where he was responsible for global development of central nervous system projects. Prior to UCB, Hepner was vice president of clinical research at Avanir Pharmaceuticals and led clinical research in Latin America for TEVA Pharmaceuticals.
Hepner initially will concentrate on the clinical development program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy, which is expected to begin later this year.