Dr. Lumpkin became Deputy Director – Regulatory Affairs and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation in January 2014. In this capacity, he leads the Foundation’s strategic initiatives around global regulatory systems. These initiatives currently include the Foundation’s regulatory systems optimization work with partners such as: (1) the World Health Organization and other multinational organizations, (2) regional and other regulatory harmonization/alignment initiatives, and (3) national and regional medical products regulatory authorities. These initiatives are focused on working with these and other partners to make more efficient and effective (without sacrificing product quality or safety) the regulatory processes through which products must pass in order to be developed, legally marketed, and overseen appropriately after marketing authorization in low- and middle-income countries.
He retired from the US Food and Drug Administration in January 2014 after just over 24 years as a part of that organization. He was most recently (2011 to 2014) the Commissioner’s Senior Advisor and Representative for Global Issues. Prior to 2011, Dr. Lumpkin was responsible for the policy development and operational aspects of the FDA’s international activities, served as the Deputy Center Director (Review Management) of FDA’s Center for Drug Evaluation and Research (CDER) and was the Director – Division of CDER’s Anti-infective Drug Products.
He is an M.D. with post-graduate training in pediatrics and pediatric infectious diseases at the Mayo Clinic in Rochester, Minnesota.