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Boston Convention and Exhibition Center

Jun 24, 2018 1:00 PM - Jun 24, 2018 4:30 PM

415 Summer Street, , Boston, MA 02210 , USA

#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban


Robert  Powell, PharmD

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

William Wang, PhD

President, Merck & Co, Inc, 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 a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials. Dr Bill Wang was elected as a Fellow of American Statistical Association (2018) and received the DIA Global Inspire Award in 2017 .

Steve  Wilson, PhD

Steve Wilson, PhD

Senior Staff Fellow, OB, OTS, CDER, FDA, United States

Dr. Wilson has worked as a mathematical statistician at FDA for more than 33 years.  He is currently a Senior Staff Fellow with the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER).  Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984. His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards, and the review of drug and biological therapies.

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