#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban
Robert Powell, PharmD
- Clinical Pharmacologist
- University of North Carolina, United States
Bob Powell, Pharm.D. is a clinical pharmacologist working on precision drug dosing research as an adjunct professor at the University of North Carolina Chapel Hill College of pharmacy. He also teaches drug development principles at the Peking University Clinial Research Institute and ECPM in Basel, Switzerland. His career has focused on early phase drug development in the industry (Glaxo, Parke Davis, Roche} and FDA.
William Wang, PhD
- Executive Director, Clinical Safety Statistics, BARDS
- Merck Research Laboratories, United States
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials. Dr Bill Wang was recently elected as a Fellow of American Statistical Association (2018) and received the DIA Global Inspire Award in 2017 .
Stephen E. Wilson, DrPH, MPH
- Statistical Consultant, United States
Statistical reviewer/manager at FDA/CDER for more than 30 years; Captain in the USPHS; Retired as Dir. of Div. of Biometrics III/Office of Biostatistics on June 1, 2017; Received a doctorate in Biostatistics from UNC Chapel Hill in 1984; Also worked for the East West Center, the Indonesian Statistics Bureau, UNC, the Fed. States of Micronesia and the World Bank; and his professional interests include regulatory thinking/decision-making, clinical trials science, and data standards.