Adrian Hepner, MD, PhD
Dr. Hepner has over 25 years of experience in US and international clinical research and drug development. Included in his experience is the development and implementation of the clinical and regulatory strategy for a number of products from early stage development through successful New Drug Application (NDA) and EU regulatory filings.
After receiving his MD degree, Dr. Hepner completed visiting research physician experiences in the Department of Psychiatry at Harvard Medical School, 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 17 years in neuropsychiatry private practice and participated in multiple clinical research studies.
Dr. Hepner’s pharmaceutical industry experience includes 15 years of progressively increasing drug development responsibilities. He had 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 other indications. Most recently, Dr. Hepner held the role of vice president of clinical research and medical affairs at BioDelivery Sciences International (BDSI), where he led the regulatory review process for the first buccal film approved for the maintenance treatment of opioid dependence. In addition, he had a critical role in the commercial launch of the product.
Prior to BDSI, Dr. Hepner was senior medical director at UCB BioSciences, Inc., where he was responsible for global development projects in the central nervous system therapeutic area. He was also vice president of clinical research at Avanir Pharmaceuticals and led global clinical research projects in Latin America for Teva Pharmaceuticals.