M. Lynn Smiley

Dr. Smiley is an independent Clinical Development Consultant providing expertise to the pharmaceutical and biotechnology industry. With 30 years of drug development experience she has contributed to drug development programs from the pre-IND through NDA submission phases across multiple therapeutic areas including infectious diseases, cardiovascular, pulmonary, ophthalmology, allergy and immunology and has contributed to the approval of 14 NDAs and over 24 INDs. Dr. Smiley holds her medical degree from the Duke University School of Medicine and is boarded in Internal Medicine and Infectious Diseases.

In 1988, Dr. Smiley joined the Department of Infectious Diseases at Burroughs Wellcome (later Glaxo Wellcome) where she was involved with a variety of drug development programs for infectious diseases and immunology. She served as the Global Project Leader for Valtrex®, co-chaired multiple joint development committees with collaborating companies, and ultimately served as Vice President, HIV and Opportunistic Infections at Glaxo Wellcome. In 2001, Dr. Smiley became Chief Medical Officer at Trimeris and subsequently held the same position at Inspire Pharmaceuticals from 2005 to 2010. She was also Senior Vice President, Drug Safety and Pharmacovigilance leading both the Drug Safety and Drug Regulatory functions. Dr. Smiley currently serves as a member or as Chairman of a number of Data Safety Monitoring Boards.