Simultaneous Global New Drug Development

Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored over 60 publications on statistical methodologies, and psychiatry, obesity and diabetes. He served as the Executive Director of the International Statistical Association (2017 - 2019). Dr. Li is a Fellow of the American Statistical Association. Dr. Hui Quan is currently the global head of the Statistical Research group of the Biostatistics and Programming Department of Sanofi. He received his PhD degree in statistics from Columbia University in 1990. He has 30 years of pharmaceutical industry experience in many therapeutic areas. He has published 108 papers including 84 statistical papers. He is a co-author/co-editor of three books. He has served as an associate editor for two journals. He is a fellow of the American Statistical Association. Dr. William (Bill) Wang is executive director in the department of biostatistics and research decision sciences (BARDS), Merck Research Laboratories. He has 25+ years of experience in clinical trial design, biostatistics, data management, and regulatory filings across multiple TAs including vaccine and oncology. From 2007 to 2014, Bill had led the design, build-up and day-to-day oversight of global biometrics operation in China. From 2014 to present, Bill has led the establishment of the clinical safety statistics group to support the clinical safety model. He is currently responsible for managing the global clinical safety statistics operation and the late develop statistics in the Asia Pacific region. Through his 20+ years tenure at Merck & Co, Inc, Bill has led the study design, execution, filing and approval by multi-regional regulatory agencies. Bill has served as the deputy topics-leader for the ICH E17 working group. The ICH E17 is an ICH efficacy guidance for designing multi-regional clinical trials in global simultaneous drug development and regulatory approval. Bill has also co-founded and co-chaired an American Statistical Association (ASA) Interdisciplinary Safety Working Group. Dr Bill Wang received the DIA Inspire Award in 2017 and was elected as a Fellow of American Statistical Association in 2018. Dr Bruce Binkowitz earned his PhD from what is now named the Rutgers School of Public Health. He is the Vice President of Biometrics at Shionogi, Inc. in Florham Park, New Jersey. Bruce has more than 30 years of pharmaceutical industry experience across many therapeutic areas as well as from early phase through phase IV clinical trials. He has experience in study design, conduct, analysis and interpretation of results for clinical trials, as well as many interactions with health authorities worldwide. Dr. Binkowitz is active in the Statistical Community, having served many leadership roles including a 3 year term on the ENAR Regional Board of Advisors; as part of the DIA Statistics Core Community including a 3 year term as the industry representative responsible for organizing the Statistics Track for the DIA Annual Meeting; and has served the statistical community as member of the American Statistical Association including as a 5-year member of the steering committee for the ASA Biopharmaceutical Section FDA/Industry Statistics Workshop, culminating as the 2013 Workshop Industry Chair. Most recently Bruce was honored to be elected as the 2020 chair of the ASA Biopharmaceutical Section. Bruce is currently in his second term as co-leader fo the cross-industry MutliRegional Clinical Trial Consistency Working Group. Bruce has taught numerous short courses on MultiRegional Clinical Trials, has been the lead or co-author on more than 40 published papers across the Statistical and Medical Literature as well as lead author or co-author on more than 45 conference and workshop presentations. Dr. Binkowitz was elected a fellow of the American Statist...