Date: Thursday 21st October 2021
Time: 14:00-16:00 BST
Location: Online
Speakers: John Scott (FDA), Olivier Collignon (GSK), Dieter Häring & Marius Thomas (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials in all therapeutic areas, from industry, CROs and academia.
What is the benefit of attending? The audience will gain insight into regulatory considerations for complex innovative designs and their use in practice.
You can now register for this event. Registration will close at 14:00 on 21st October.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Complex Innovative Designs (CID) in practice. Speakers from regulatory authorities and industry will present on their experience, which will include the following aspects:
• Overview of the FDA Complex Innovative Trial Design pilot program and the applications received to date together with details on some of them
• Overview of the FDA guidance on interacting on Complex Innovative Trial Designs
• Detailed case study of a clinical trial in children which was evaluated within FDA’s CID pilot program, applying borrowing of information from external trials in adults
• Overview of statistical and regulatory considerations on master protocols, focusing on Phase III confirmatory trials.
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Speaker |
Biography |
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John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics. |
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Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe. |
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Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs.
He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland. |
 Marius Thomas (Novartis) |
Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program.
Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University. |
