Simultaneous Global New Drug Development (ePub)

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 Statistical Association in 2015.

Dr. Yonghua (Joshua) Chen received his PhD in Statistics from the University of Wisconsin-Madison, and Master and Bachelor degrees in Probability and Statistics from Peking University. He is currently the Head of Global Biostatistical Sciences at Sanofi Pasteur. Before joining Pasteur, Josh worked on clinical development of small molecules, biologics and vaccines at Merck Research Labs. His experience spans many therapeutic areas with major focus on human vaccines and antiviral drugs. He has extensive experience in study design, conduct and reporting of international clinical trials from proof-of-concept through regulatory approvals and life cycle management. His primary research interest is clinical trial designs, including group sequential methods, adaptive designs and multiregional clinical trials (MRCTs). He was a co-lead of the across-industry MRCT Consistency Working Group under PhRMA (2008-2011) and Society for Clinical Trials (2012-2014). Dr. Chen is a Fellow of the American Statistical Association.