Toshimitsu Hamasaki is the Director of Data Science at National Cerebral and Cardiovascular Center (NCVC), Osaka, Japan. He has been involved in biopharmaceutical statistics for over 20 years, and prior to joining NCVC, worked at Shiogoni, Pfizer Japan and Osaka University. He has been actively involved in biostatistical research, and is the author of more than 150 peer-reviewed publications and three textbooks on clinical trials including Group-Sequential Clinical Trials with Multiple Co-Objectives. Dr. Hamasaki was the member of ICH E5 Guideline Implementation Working Group as a representative of Japan Pharmaceutical Manufacturers Association to develop the Q & A document on the guideline. He currently serves as an Associ-ate Editor for Statistics in Biopharmaceutical Research and Journal of Biopharmaceutical Sta-tistics, and Editor for CHANCE. He is an elected member of International Statistical Institute and a Fellow of the American Statistical Association (ASA). He is a recipient of the Japanese Society of Computational Statistics Distinguished Article Award and Behaviormetric Society of Japan Hida-Mizuno Prize, and the Poster Competition Winner at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop.
Scott R Evans is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG). His interests include the design, monitor-ing, analyses, and reporting of and education in clinical trials. He is the author of more than 100 peer-reviewed publications and three textbooks on clinical trials including Fundamentals for New Clinical Trialists. Dr. Evans is a member of an FDA Advisory Committee, the Board of Directors for the American Statistical Association, the Society for Clinical Trials and Mu Sigma Rho (the National Honorary Society for Statistics), and the Steering Committee of the Clinical Trials Transformation Initiative (CTTI). He is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID). Dr. Evans is a Visiting Professor at the Department of Innovative Clinical Trials and Data Science at Osaka University in Japan. He is the Past-President of the Boston Chapter of the American Statistical Association (ASA), the Past-Chair of the Development Committee of ASA, the Past-Chair of the Teaching Statistics in the Health Sciences section of ASA, and the Past-Chair of the Statistics in Sports section of ASA. Dr. Evans is a recipient of the Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award, and is a Fellow of the ASA.