The use of Bayesian methods within clinical development has greatly increased in recent years. This is particularly true for earlier stage trials but they are also being used in later stage work. In this webinar, three different examples of where Bayesian methodology has been used within confirmatory settings will be provided. The examples describe:
A Bayesian framework used to incorporate several interim analyses to monitor the trial for efficacy and futility, while controlling the overall type 1 error.
Use of the meta-analytic-predictive prior methodology, interpreting study data in the context of trial external data while accounting for between-trial heterogeneity.
Incorporating a hybrid external control arm using Bayesian dynamic borrowing with propensity score matching.
Who is this event intended for? Statisticians in the pharmaceutical industry with an interest in Bayesian methodology.
What is the benefit of attending? Attendees will have the opportunity to learn about Bayesian methods and their application in later stage studies.
Please note: Due to unprecedented demand, access to the live session will operate on a first come, first serve basis - registration does not guarantee attendance for our most popular free events. If you are not able to gain entry to attend the webinar live, there will be a recording made available a week or two after the event. We thank you for your understanding, and for your interest in this topic!
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Executive Director of Pfizer
Dr. Satrajit Roychoudhury is an Executive Director and a member of Statistical Research and Innovation group in Pfizer Inc. He has 17 years of extensive experience in working with different phases of clinical trials for drug and vaccine. His research interest includes survival analysis, use of model-based approaches and Bayesian methods in clinical trials. He served as the industry co-chair for ASA Biopharmaceutical Section Regulatory-Industry Workshop in 2018 and co-chair for DIA/FDA Biostatistics Industry and Regulator Forum in 2023. Satrajit is an elected Fellow of the American Statistical Association and recipient of Royal Statistical Society (RSS)/Statisticians in the Pharmaceutical Industry (PSI) Statistical Excellence in the Pharmaceutical Industry Award in 2023 and Young Statistical Scientist Award from the International Indian Statistical Association in 2019.
Vice President and Head of Statistics and Modeling for Vaccine Clinical Research and Development at Pfizer
Ken Koury is Vice President and Head of Statistics and Modeling for Vaccine Clinical Research and Development at Pfizer. He is responsible for all statistical aspects of global clinical research and development of vaccines to meet licensure and post licensure requirements, and he has over 35 years of experience in drug and vaccine development. Ken has previously served as Co-Chair of the FDA/Industry/Academia Safety Graphics Working Group, on PhRMA’s Biostatistics and Data Management Technical Group, as Program Chair and Chair of the ASA Biopharmaceutical Section, and on the Steering Committee for several Regulatory-Industry Workshops.
Director in the Department of Advanced Methodology and Data Science at Novartis
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Emma Clark has 30 years experience as a statistician in the UK Pharmaceutical Industry. Her early experience was for a UK Affiliate, supporting late phase studies across a number of therapeutic areas. Emma joined Roche Products Ltd 14 years ago where she has worked solely on oncology clinical trials in breast cancer and haematology. In 2020/2021, Emma participated in Company collaborations with the FDA on the use of a hybrid external control arm using Bayesian dynamic borrowing in a randomized phase 3 study in Diffuse Large B-Cell Lymphoma.