Innovative Drug Development at a Glance – The Concepts, the Vision, and the Factors to Consider

Zoran Antonijevic is Head of Biometrics at MedSource. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Adaptive Design Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and “Platform Trials in Drug Development”.

Group Sequential Designs and Sample Size Re-estimation – Modern Uses

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 35 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. More recently, he has written with a variety of co-authors on adaptive trial design and over-arching optimisation of the drug development process.

Professor Jennison's research is informed by experience of clinical trial analysis at the Dana Farber Cancer Institute, Boston and a broad range of consultancy with Pharmaceutical companies.

Practical Model-based Approaches for Phase I Oncology Trials

Dr. Satrajit Roychoudhury is a Senior 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 in Novartis. He started his career as a research statistician in Schering Plough Research Institute (now Merck Co.). He has 12+ years of extensive experience in working with different phases of clinical trial. His primary expertise includes implementation of innovative statistical methodology in clinical trial. He has co-authored several publications/book chapters in this area and provided statistical training in major conferences. His area of research includes survival analysis, use of model-based approaches and Bayesian methods in clinical trials. Satrajit was a recipient of a Young Statistical Scientist Award from the International Indian Statistical Association in 2019.

Introduction to Population Enrichment Trial Designs

Thomas is a Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, where his main research interests are Adaptive clinical trials and personalised medicine.  He studied for his BSc in Mathematics and Statistics with placement at the University of Bath, spending a year working on sample design at the Office for National Statistics.  Thomas also holds a PhD from the University of Bath, this was a case studentship that involved working closely with Roche Products Ltd researching the Bayesian optimisation of Adaptive Enrichment trials.