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Virtual

Mar 23, 2023 3:00 PM - Mar 23, 2023 7:00 PM

(US Eastern Standard Time)

Short Course: Group Sequential and Adaptive Designs in Drug Development: Methodology, Practical Aspects, and Examples

This is a Virtual Pre-Conference Short Course in conjunction with the DIA/FDA Biostatistics Industry and Regulator Forum

Instructors

Satrajit  Roychoudhury, PhD

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.

Marc  Vandemeulebroecke, PhD, MSc

Marc Vandemeulebroecke, PhD, MSc

Global Group Head, GDD Analytics, Novartis, Switzerland

Marc Vandemeulebroecke joined Novartis in 2006. He has been supporting development programs in early and late phase development across various disease areas as statistician and pharmacometrician. Currently he is Global Group Head in Immunology. He received the Gustav-Adolf-Lienert award from the German Region of the International Biometric Society (IBS) for his PhD thesis, which focused on adaptive designs. He co-authored various scientific publications and one R package, and has been teaching on group sequential and adaptive designs as well as statistical graphics. Marc's current interests include machine learning and regulatory statistics.

Christoper  Jennison, PhD

Christoper Jennison, PhD

Professor of Statistics, Department of Mathematical Sciences, University of Bath, United Kingdom

Christopher Jennison is Professor of Statistics at the University of Bath, UK. His PhD research at Cornell University concerned the sequential analysis of clinical trials and he has continued to work in this area for over 40 years. His book with Professor Bruce Turnbull, "Group Sequential Methods with Applications to Clinical Trials", is a standard text on this topic and is widely used by practising statisticians. The second edition of this book, extended to cover adaptive designs, is nearing completion. Professor Jennison's research is informed by experience of clinical trial analysis at the Dana Farber Cancer Institute, Boston, by service on data monitoring committees, and by a broad range of consultancy with pharmaceutical companies.

Keaven  Anderson, PhD

Keaven Anderson, PhD

Scientific AVP, Methodology Research, Merck & Co., Inc., , United States

A Fellow of the ASA and a Distinguished Scientist focusing primarily on statistical support for late-stage oncology drug development at Merck Research Laboratories since 2003. Areas of research have included risk prediction for cardiovascular disease and adaptive design with a focus on group sequential design. A current interest is in non-proportional hazards models and multiplicity in group sequential trials due to their relevance for immuno-oncology development. Keaven has previously worked in many drug, biologic and vaccine development areas at Merck and at Centocor/J&J. He is the primary author and maintainer of the open source R package gsDesign and its associated web interface for designing group sequential trials.

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