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Scientific committee

Annette Kopp-Schneider is head of the division of Biostatistics at the German Cancer Research Center (DKFZ). She holds a doctorate in mathematics and computer science from RWTH Aachen. Her research interests range from stochastic modeling of cellular processes and dose-response modeling to clinical statistics. Her involvement as biostatistician for the pediatric oncology trial series INFORM2 has started her interest in precision oncology and Bayesian clinical trial design. Her focus is on the use of external information in clinical trials and the impact on trial operating characteristics.

Thomas Jaki is Professor of Computational Statistics at the University of Regensburg and MRC Professor of Statistics and Programme Leader in the Efficient Study Design theme at the MRC Biostatistics Unit. His work focuses on developing and evaluating novel statistical methods for clinical studies. These methods are adapted for specific applications to ensure they can be used in the pharmaceutical industry and also in public sector research institutions. His current research focuses on model-based dose-finding trials as well as Master protocols.

Franck Pellissier is a seasoned Sanofi statistician with more than 25 years of experience in the pharmaceutical industry. He started his career working on the submission of an antithrombotic product. He then spent several years as a project statistician dedicated to early clinical development, contributing to projects in various therapeutic areas. For the next few years, Franck split his time between technical method consulting and project statistical management. He mentored his fellow statisticians on pharmacokinetic study designs and methods, while continuing to manage the statistical aspects of projects. Currently, Franck is fully dedicated to technical methods and consulting, primarily in early clinical development. His work mainly focuses on implementing innovative designs and methods to accelerate and de-risk early clinical development. This includes strengthening quantitative decision-making processes through the use of Bayesian methods, adaptive designs, and predictive biomarkers, as well as exploring the integration of artificial intelligence. He also regularly participates in early development steering review meetings and oversees technical working groups within the early development team.

Kit Roes is Professor of Biostatistics at Radboud University Medical Center Nijmegen (Netherlands). He is chair of the Methodology Working Party of the European Medicines Agency, and senior expert at the Dutch Medicines Evaluation Board. His research focus is design and analysis of clinical trials, with an emphasis on innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He is currently involved as work package lead in multiple Horizon Europe funded projects that aim to improve clinical research for regulatory decision making. He serves on multiple Data Monitoring Committees. His experience includes over 25 years in clinical research in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.

Marta Bofill Roig is a Serra Húnter Fellow (tenure-track lecturer) at the Universitat Politècnica de Catalunya - BarcelonaTech (UPC). Marta graduated in Mathematics and earned a Master's in Statistics and Operations Research. After obtaining her PhD in 2020, she worked as a postdoctoral researcher at the Medical University of Vienna. She joined the Department of Statistics and Operations Research at the UPC in September 2024 in her current position. Her research areas include adaptive designs and survival analysis. In recent years, she has focused her research on methods and software for the design and analysis of platform trials, with particular interest in using non-concurrent control data.

Gaëlle Saint-Hilary is statistical methodologist, CEO and founder of Saryga, a company dedicated to support innovation in statistics and decision-making in healthcare. With about 20 years of experience in the pharmaceutical industry (Servier, Novartis) and a strong and long-lasting collaboration with academia, Gaëlle Saint-Hilary has worked at developing novel approaches to improve drug development’s performances. Her main scientific interests are quantitative decision-making, benefit-risk assessment, innovative study designs and historical data use.

Pascale Tubert-Bitter is Director of Research at the French National Institute of Health and Medical Research (Inserm) and head of the research team “High-Dimensional Biostatistics for Drug Safety and Genomics” at the Inserm – Paris-Saclay University Center in Epidemiology and Population health. She previously headed the research unit « Biostatistics, Biomathematics, Pharmacoepidemiology and Infectious Diseases ». She has a PhD in Mathematics from the Pierre and Marie Curie University in Paris. Her research interests concern the statistical methods to assess treatment effects, mainly in the postmarketing phase, and in areas pertaining to adverse drug reaction risks: automated signal detection from large pharmacovigilance databases, methodological issues raised by medico-administrative data in pharmacoepidemiology and benefit-risk ratio analyses, in particular for vaccines. She has responsibilities in research training (Graduate School of Public Health councils, Paris-Saclay University). Pascale Tubert-Bitter is also involved in public health expertise, in particular with the French Medicines Agency (ANSM), and currently member of the Scientific Committee of EPI-PHARE, the public expertise group in epidemiology of health products (ANSM - French Social Security organization). She is also Secretary of the French Region of the International Biometric Society (IBS) since 2015, former Chair of the IBS-Education Committee, and elected member since 2006 of the Biopharmacy and Health Group board of the French Statistical Society.

Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He holds a PhD in Physics from the TU Darmstadt and joined Novartis 10+ years ago. He has worked extensively 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.

Sarah Zohar is the head of the research department HeKA dedicated to Digital Health affiliated to Inserm, Inria and University Paris Cité located at PariSanté Campus. She is an expert in innovative methods for interventional and observational health data modeling including drug and Digital Medical Devices evaluation. She has made many methodological contributions for exploratory clinical trials and Real World Data analysis proposing novel methods and approaches that have been applied in cancer, rare diseases, resistance to antibiotics and pediatric clinical trials among other fields. She has collaborated with physicians in the designing, planning, conducting and analyzing clinical trials and she has developed new approaches in collaboration with international methodological experts from USA, Japan and Europe.She is coordinating the EU Horizon collaborative project INVENTS "Innovative designs, extrapolation, simulation methods and evidence-tools for rare diseases addressing regulatory needs" and co-leading the France 2030 PEPR Digital Health SMATCH "Statistical and AI based Methods for Advanced Clinical Trials CHallenges in Digital Health".