July 23, 2013
/PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that
, M.D., Ph.D., has joined the company as Vice President of Clinical Research and Regulatory Affairs. Dr. Hepner joins BDSI with over twenty years of experience in U.S. and international clinical research and drug development, which includes development and implementation of the clinical and regulatory strategy for a number of products from early stage development through New Drug Application (NDA) and E.U. regulatory filings.
After receiving his M.D. degree, Dr. Hepner completed visiting research physician experiences in the Department of Psychiatry at
Harvard Medical School
and the Department of Neurology at the National Institute of Mental Health and a post-doctoral fellowship in neuropharmacology at the
University of Ottawa
. Additionally, he spent fifteen years in neuropsychiatry private practice and participated in clinical research studies.
Dr. Hepner's pharmaceutical industry experience includes over twelve years of progressively increasing drug development responsibilities, including a critical leading 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, Dr. Hepner held the role of Senior Medical Director at UCB BioSciences, Inc., where he was responsible for global development projects in the central nervous system therapeutic area. Prior to his experience at UCB, Dr. Hepner was Vice President of Clinical Research at Avanir Pharmaceuticals and led clinical research in
for TEVA Pharmaceuticals.
Dr. Hepner will initially 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. His prior experience and clinical research in this disorder will be instrumental in leading the Clonidine Topical Gel development program.