Yi Tsong, Ph.D.
Yi Tsong received his Ph.D. in Statistics from the University of North Carolina at Chapel Hill in 1979. He did his post-doctoral training in cardiovascular prevention and biostatistics at Northwestern Medical School (1978-1980). He worked as senior statistician in pattern recognition at Lockheed Engineering and Management Company (1981-1983) and biostatistical consultant at the University of Texas Medical Branch at Galveston (1984-1987) before joining FDA. He served as team leader of postmarketing risk assessment and statistical reviewer of NDA submission of critical care and pain relief products.
He is currently the Deputy Division Director and Acting Team Leader for statistical team of Chemistry and Manufacturing Control. He specializes in postmarketing risk assessment, drug manufacturing process control and quality assurance, active control noninferiority/equivalence tests, adaptive designs and QTc trials. He received 8 CDER and 12 FDA level awards for contributions in postmarketing drug risk assessment, for advisory on CDER postmarketing risk assessment external contracts, medication errors, quality control evaluation, drug compliance, in vitro bioequivalence, drug compliance, drug abuse potential studies, setting quota of scheduled substances, adaptive design and non-inferiority tests, et al. He publishes frequently in numerous professional journals. He served as Treasurer, Board Director and President of International Chinese Statistical Association. He serves also as the Associate Editor of Statistics in Medicine and Journal of Biopharmaceutical Statistics.
Shein-Chung Chow, Ph.D.
Dr Shein-Chung Chow is a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine. Prior to joining Duke University, he was the Director of TCOG (Taiwan Cooperative Oncology Group) Statistical Center and the Executive Director of National Clinical Trial Network Coordination Center. Dr. Chow also held various positions in the pharmaceutical industry. Through these positions, Dr. Chow provided technical supervision and guidance to project teams on statistical issues and presentations before partners, regulatory agencies or scientific bodies, defending the appropriateness of statistical methods used in clinical trial design or data analyses or the validity of reported statistical inferences. Dr Chow has extensive publication on clinical trials design and statistical methods. Dr. Chow is the author or co-author of over 250 methodology papers and over 23 books, which include Design and Analysis of Bioavailability and Bioequivalence Studies, Design and Analysis of Clinical Trials, Encyclopedia of Biopharmaceutical Statistics, Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Controversial Statistical Issues in Clinical Trials, and Biosimilars: Design and Analysis of Follow-on Biologics. One of his most recent books is on Clinical Trial Designs for Chinese Traditional Medicine to be published by Chapman & Hall, USA. Dr. Chow’s professional activities include playing key roles in many professional organizations such as officer, Board of Directors member, Advisory Committee member, and Executive Committee member. Dr Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics. Dr. Chow is also the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. Dr Chow was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. Dr Chow was the recipient of the DIA Outstanding Service Award (1996), ICSA Extraordinary Achievement Award (1996), and Chapter Service Recognition Award of the American Statistical Association (1998). Dr. Chow was appointed Scientific Advisor to the Department of Health, Taiwan in 1999-2001 and 2006-2008. Dr. Chow was President of the International Chinese Statistical Association, Chair of the Advisory Committee on Chinese Pharmaceutical Affairs, and a member of the Advisory Committee on Statistics of the DIA.
