#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
Bill has over 24 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA Global Inspire Award for Global Connector in 2017. Currently chairs an ASA safety working group, and serves as a deputy topics leader for the ICH E17 working group on Multi-Regional Clinical Trial (MRCT).
Stephen E. Wilson, DrPH, MPH
- Statistical Consultant, United States
Dr. Wilson served as a statistical reviewer and manager at FDA for more than 30 years. A Captain in the USPHS he was retired as Director of CDER’s Div. of Biometrics III/Office of Biostatistics on June 1, 2017. Steve received his doctorate in Biostatistics from UNC Chapel Hill, in 1984. Prior to FDA, Dr. Wilson’s professional experience included positions with the East West Center, the Indonesian Statistics Bureau, UNC, the Federated States of Micronesia and the World Bank. His professional interests and activities are focused on issues related to improvements in statistical thinking/decision-making, institutional development, clinical trials science and practice, data standards and the regulatory review of drug and biological therapies.