Practical Bayesian Approaches in Healthcare: Industry and Regulatory Perspectives

Instructors

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  Satrajit Roychoudhury, PhD

  • Executive Director, Statistical Research and Innovation
  • Pfizer, Inc., United States

  Dr. Satrajit Roychoudhury is an Executive Director and a member of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical methodology in clinical trials. He has co-authored several publications/book chapters in this area and provided statistical training at major conferences. His areas of research include the use of survival analysis, model-informed drug development and Bayesian methods in clinical trials.

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  Lisa Hampson, PhD

  • Senior Director, Advanced Methodology & Data Science
  • Novartis Pharma AG, Switzerland

  Lisa is a member of the Statistical Methodology group at Novartis and is based in Basel. Prior to joining the pharmaceutical industry, Lisa was a Lecturer in Statistics at Lancaster University, and held a UK Medical Research Council Career Development Award in Biostatistics. Her research interests are in clinical trials, including group sequential tests, adaptive designs for treatment selection, and Bayesian approaches for early phase dose-escalation trials. More widely, she is interested in developing approaches for leveraging existing information in trials, extrapolation, and methods to evaluate the probability of success of a drug development program. Lisa holds a PhD in Statistics from the University of Bath.

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  John Scott, PhD, MA

  • Director, Division of Biostatistics, OBPV, CBER
  • FDA, United States

  John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College, and is a Fellow of the American Statistical Association.

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  Mark Rothmann, PhD

  • Division Director
  • FDA, United States

  Dr. Rothmann (Mark) is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990. He then spent the next nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, when he was a reviewer and team leader he was involved in the review on Oncology, Hematology, and Metabolism and Endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials. He leads three Office of Biostatistics Working Groups and Committees in Bayesian Analysis, Drug Trials Snapshots and Pediatric Studies and has serves on many other groups.

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  James Travis, PhD

  • Lead Mathematical Statistician, OB, OTS, CDER
  • FDA, United States

  James Travis is a lead mathematical statistician in the Division of Biometrics II in the Office of Biostatistics in CDER leading the team supporting the Division of Pediatric and Maternal Health. James joined the Agency in 2014 following completion of his PhD at the University of Maryland, Baltimore County. He is a representative on the Pediatric Review Committee for the Office of Biostatistics. He has interests in Bayesian methods, particularly the use of informative priors in pediatric clinical trials.