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Bayesian approaches to address clinical development challenges for COVID-19 vaccine / drugs /devices

Please join us and participate in this virtual expert panel to discuss how adaptive Bayesian designs may help to address the challenges inherent in COVID-19 trials,

Click here to register. 

Rajat Mukherjee, PhD
Research Fellow, Cytel

RajatRajat Mukherjee is Principal, Strategic Consulting at Cytel. He has more than 20 years of professional experience as an industry and academic statistician, and brings a range of expert knowledge to Cytel’s customers. This includes work in Pattern Recognition problems for devices and biomarker discovery, Bayesian clinical trials, adaptive designs, and design and analysis of complex epidemiological studies.

Frank Harrell, phd
Professor of Biostatistics, Vanderbilt University

frank harrell

  • Professor and founding Chair of the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville TN USA
  • PhD in Biostatistics from U. North Carolina
  • Extensive work in biomedical and pharmaceutical research
  • ASA Fellow and winner of the ASA WJ Dixon Award for Excellence in Statistical Consulting in 2014
  • Publications and full biography
  • Active on stats.stackexchange.com - see my posts here
  • Written several R packages including Hmisc and rms
  • Used R intensively since 1999 and am a member of the R Foundation
  • Author of Regression Modeling Strategies, 2nd Edition
  • Statistical knowledge outside the areas of regression modeling strategies and Bayes is in BBR
  • Expert Statistical Advisor to the Office of Biostatistics, Center for Drug Evaluation and Research, FDA

Gregory Campbell, phd
Former Director of Biostatistics, U.S. Food and Drug Administration

greg campbell

Dr. Gregory Campbell received his PhD in Mathematical Statistics from the Florida State University in 1976. After his completion of graduate studies, Dr. Campbell took a faculty position as an assistant professor in the Department of Statistics at Purdue University, and later joined the intramural program of the National Institutes of Health, where he was promoted to a senior investigator with tenure, and he served as the Acting Chief for the Laboratory of Statistical and Mathematical Methodology, and then Chief of the Analytical Biometrics Section.

Dr. Campbell joined the Food and Drug Administration (FDA) in 1995, and served as the Director of the Division of Biostatistics in the Office of Surveillance and Biometrics of the Center for Devices and Radiological Health (CDRH) at the FDA until his retirement from the federal government at the end of June 2015. His extraordinary leadership has resulted in the growth of the Division from 18 mathematical statisticians to 62 in five branches. He has made exceptional contributions to public health, the FDA, and medical device industry by leading the Division to provide statistical support to CDRH as a whole and, in particular, the statistical reviews of FDA’s pre-market device submissions, bringing in numerous important and innovative medical devices to the market place.

Bernard Fritzell, M.D.
Executive Advisor, Cytel

FritzellBernard Fritzell is an independent consultant with 30 years of experience in the clinical development of several human vaccines. He is the former Vice-President, International Scientific and Clinical Affairs, Pfizer Vaccines Research, former Chairman of the clinical working group of the European Vaccines Manufacturers (EVM).
Dr Bernard Fritzell obtained his medical diploma from the University of Bordeaux (France) as well as his degree in Tropical Diseases and Health and Development. During his career, he has held senior positions in the medical department of Pasteur-Merieux-Connaught, Chiron vaccines and Wyeth.