Dr. Fleming is Professor in the Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, and former Director of the Statistical Center for HIV/AIDS National Institutes of Allergy and Infectious Diseases Prevention Trial Network. He has authored or coauthored several books and more than 250 research articles in peer-reviewed journals, many regarding development of state of the art methods for the design, conduct and analysis of clinical trials, and many others reporting the results of landmark trials including the 2011 NEJM publication on prevention of HIV transmission. This research, on which he was senior author, was recognized by Science Magazine as scientific “Breakthrough of the Year”. Dr. Fleming is the former Chair of Biostatistics at the University of Washington. He has chaired or served on Data Monitoring Committees for more than 100 clinical trials. In addition, Dr. Fleming is a Special Government Employee for the FDA, and for more than 25 years he has served as a regular member of FDA Advisory Committees and as an invited voting member on more than 100 occasions. Dr Fleming has received numerous awards including Outstanding Teaching Award in the School of Public Health from the University of Washington, and the FDA Commissioner’s Special Citation Award for Extraordinary Contribution to the Agency. He was the 2007 Greenberg Lecturer at University of North Carolina, the 2009 Distinguished Lecturer at the School of Public Health at the University of Washington and, in 2011, the Ross Prentice Endowed Professor of Biostatistical Collaboration. In 2012, he was elected to membership in the Institute of Medicine of the National Academies.