Formerly-Executive Vice President and Worldwide Head of Regulatory Affairs, Human Safety, and Quality at Wyeth Pharmaceuticals.
D. Bruce Burlington, M.D., an infectious disease internist, is a well known independent consultant on pharmaceutical product development and regulatory affairs. His experience includes senior positions at both the FDA and in the pharmaceutical industry. He blends long experience in development strategy with insightful analysis of the underlying medical problems, patient needs, how the results will be viewed by the FDA and EMEA, and what outcomes will result in commercial success.
Dr. Burlington was Executive Vice President and worldwide head of Regulatory Affairs, Human Safety, and Quality at Wyeth. He led the company in the development and U.S. and global registration of many products as well as improving Wyeth's compliance posture. He also successfully navigated the company through an FDA consent degree. During these eight years, as a member of many Wyeth governance councils and committees, he participated broadly and in depth analyzing the complex forces driving the business side of the industry.
Before joining Wyeth, Dr. Burlington served at the FDA for 17 years. He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH), where he led major changes, increased the rigor of clinical investigation for medical devices, and championed innovations in how the Center could work more productively with industry. Before that he was a research immunologist and then a manager in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). In these centers he had responsibility for viral vaccines, investigational biologics, BLA review, NDA approvals, generic drugs and, as medical Deputy Director in CDER, policy and compliance decisions for pharmaceuticals.