Leonard Sacks received his medical education in South Africa, moving to the USA in 1987, where he completed fellowships in immunopathology and Infectious Diseases. He worked as an attending physician in Washington DC and South Africa and he joined the FDA in 1998 as medical reviewer in the Office of New Drugs. Subsequent positions included acting director of the Office of Critical Path Programs and associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. In this capacity he has led efforts to support the use of electronic technology in clinical drug development. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented extensively on these topics. He is board certified in Internal Medicine and Infectious Diseases and holds an academic appointment as Associate Clinical Professor of Medicine at George Washington University.