Dr Géraldine Favrais (University Hospital of Tours)
Dr Géraldine Favrais (MD, PhD) is neonatologist in the University Hospital of Tours (France). Her research topic focuses on brain development and all cerebral disturbances occurring during the fetal and neonatal periods. She recently obtained a French government grant for LEVNEONAT project including 5 French University Hospitals. The LEVNEONAT principal aim is to establish the safest and the most efficient dose of levetiracetam, an anti-epileptic drug, as a first-line treatment of neonatal seizures occurring in hypoxic-ischemic encephalopathy context following a phase II study schedule. Sarah Zohar’s methodological team (Paris) is closely linked to this project design. Inclusions should begin during the second semester of 2017.
Prof Dr Oliver Gross, University Medical Center Göttingen
Dr Gross is Professor of Internal Medicine at University of Göttingen, and head attending Nephrologist. Dr Gross is recognized as a leader in the field of type IV collagen diseases and collagen receptors with numerous original articles on potential therapies of extracellular matrix diseases such as Alport syndrome, including studies of murine type IV collagen knockouts. He is Initiator and Coordinating Principal Investigator of the world’s first clinical trial in children with Alport syndrome EARLY PRO-TECT Alport. The placebo-controlled trial assesses the safety and efficacy of ramipril. He founded the European Alport Registry. Dr Gross has authored numerous original research articles, reviews and book chapters on type IV collagen diseases. He has lectured on these topics at numerous institutions and meetings, both nationally and internationally.
Dr Lisa Hampson, Lancaster University
Lisa Hampson is a member of the Statistical Innovation Group, Advanced Analytics Centre, at AstraZeneca and is a Lecturer in Statistics at Lancaster University. Her research interests are in clinical trials, including group sequential and adaptive designs, and Bayesian methods for the design and interpretation of studies in small populations. She holds a PhD in Statistics from the University of Bath.
Prof Dr Ralf-Dieter Hilgers, Aachen University
Prof Dr Ralf-Dieter Hilgers studied mathematics at RWTH Aachen University. He finished his doctoral thesis at the statistical faculty of the University of Dortmund in 1991. In 2000 he received the Venia Legendi for Medical Statistics at the University of Cologne. Since 2001 he is head of the Department of Medical Statistics (IMSA) at the Medical Faculty, RWTH Aachen University. His research interest is in optimal design of experiments, randomizations procedure and clinical trials. Since 1987 he gives biostatistical advice to clinical and experimental trials in all clinical and preclinical areas. Professor Hilgers teaches 300 students in different bio-scientific areas per year and is responsible for the education of investigators in clinical trials. He also acts as reviewer for methodological and clinical journals with main focus on surgical trials. Currently he is coordinator of the IDeAl project funded by the European Community (www.ideal.rwth-aachen.de), which will establish new methodologies for small population group trials.
Dr Beat Neuenschwander, Novartis
Beat Neuenschwander got his PhD in Statistics in 1991 from the University of Bern, Switzerland. He then worked as a statistical consultant and analyst for the Institute of Social and Preventive Medicine, University of Berne, and the Swiss Federal Office of Public Health. In 2001, Beat joined Novartis Pharmaceuticals where he has been working in modeling & simulation and statistical methodology. Beat has been applying Bayesian statistics for 25 years, with a focus on the design of Phase I and Phase II trials, evidence synthesis, predictive inference, subgroup analysis, and the derivation of prior distributions from historical data.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. He leads the methodology group as part of the UMC Utrecht clinical trial center. His present research focus is on design and analysis of clinical trials, with an emphasis of innovative designs and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands and is Principal Investigator of the EU Framework Program 7 project Asterix, on design and analysis of clinical trials for drug development in rare diseases. He is advisor to the Dutch Medicine Evaluation Board.
His experience includes over 15 years in research and development in the pharmaceutical industry and life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions. Additionally, he has over 10 years of experience in industrial statistics and quality management in industry and healthcare, both as consultant and in senior management positions.
Dr Heinz Schmidli, Novartis
Heinz Schmidli studied Mathematics at the University of Basel, Switzerland, and received his PhD in Statistics in 1994. Since 2007 he is a member of the Statistical Methodology group at Novartis. In 2012 he received the Paul-Martini-Prize of the GMDS (jointly with Tim Friede), and in 2013 the Novartis leading scientist award.
Hanneke van der Lee, MD, PhD, Academisch Medisch Centrum Universiteit van Amsterdam
Hanneke van der Lee has worked as a clinical epidemiologist at the Pediatric clinical research Office in the Emma Children’s Hospital AMC Amsterdam since 2003. Her main interests are systematic reviews, clinimetrics, and RCT methodology related to optimal sample sizes. Since July 2009 she has been the convener of the international Standard Development Groups on Data Monitoring Committees and Adequate Sample Sizes of StaR Child Health, a global initiative to improve the quality of research with children (www.starchildhealth.org). From 2011 to 2015 she participated in the EU FP7 funded Global Research in Pediatrics (GRiP) network of excellence (http://www.grip-network.org), and since October 2013 she has been the leader of work package 4 (Improved use of patient level information and perspectives) in the Asterix (Advances in Small Trials dEsign or Regulatory Innovation and eXcellence) consortium (http://www.asterix-fp7.eu).
Dr Simon Wandel, Novartis
Simon Wandel holds a master in Statistics and a PhD in Medical Statistics/Epidemiology (both from University of Bern). In 2010, he joined the Early Clinical Biostatistics Group at Novartis Oncology as statistician, where he had roles with increasing responsibility. In 2013, he co-founded a start-up specialized for Bayesian statistics (Cogitars GmbH), before he joined Novartis Oncology’s Statistical Methodology Group as Expert Statistical Methodologist in April 2014.
Simon Wandel has a particular interest in application of Bayesian statistics for clinical trials and evidence synthesis. He has worked as responsible or consulting statistician for more than 30 fully Bayesian phase I/II trials, which included extensive work with other statisticians, clinicians, approval boards and regulatory agencies.
Prof Dr Gernot Wassmer, Medical University of Vienna
Gernot Wassmer is adjunct Professor for Biostatistics at the Institute of Medical Statistics, University of Cologne, Germany. He received his PhD 1993 at the University of Munich, Germany, and was a Research Fellow at the Institute of Statistics, University of Munich, at the Institute for Epidemiology, GSF Neuherberg, and at the Institute of Medical Statistics, University of Cologne. His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials. He has been a member in independent data monitoring committees for international, multi-center trials on different therapeutic fields and also serves as a consultant for the pharmaceutical industry. Currently, he is guest professor at the Medical University of Vienna, Austria.
Dr Willan is an academic biostatistician and clinical trial methodologist, and currently holds the positions of Senior Scientist at SickKids Research Institute, Professor of Biostatistics in the Dalla Lana School of Public Health at the University of Toronto, and Professor Emeritus in the Department of Clinical Epidemiology and Biostatistics at McMaster University. His contributions to statistical methodology include publications in the areas of cost-effectiveness analysis, value of information methods, management trials, crossover trials, non-nested regression analysis and bivariate response models. Dr Willan has been particularly instrumental in developing the field of statistical analysis of cost-effectiveness data with twenty peer-review articles and a book, co-authored with Professor Andy Briggs, in the Wiley Statistics in Practice series, entitled Statistical Analysis of Cost-effectiveness Data. More recently Dr Willan’s research interest has focussed on using value of information methods for the optimal design and analysis of clinical studies, with eight peer-reviewed articles and a forthcoming book, co-authored with Professor Simon Eckermann and Maggie Hong Chen, in the Wiley Statistics in Practice Series, entitled Value of Information Methods in Evidence-based Medicine: Jointly Optimizing Health Care and Research. Dr Willan’s collaborative research has been primarily in clinical trials in obstetrics and paediatrics with numerous high profile trials published in NEJM and The Lancet. Previously positions held included the Head of Biometry of the Clinical Trials Program at the National Cancer Institute of Canada and the Head of Clinical Trials and Epidemiology for the Cancer Program at Sunnybrook Medical Centre in Toronto.
This project has received funding from the European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement number FP HEALTH 2013 - 602144.