BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: Thursday 21st October 2021\nTime: 14:00-16:00 BST\nLocati on: Online\nSpeakers: \;John Scott \;(FDA)\, \;Olivier Collign on \;(GSK)\, \;Dieter Hä\;ring &\; Marius Thomas \;(Nov artis).\n\nWho is this event intended for? \;The event is intended for statisticians involved in the design of clinical trials in all therapeuti c areas\, from industry\, CROs and academia.\nWhat is the benefit of atten ding? \;The audience will gain insight into regulatory considerations for complex innovative designs and their use in practice. \;\nRegistra tion\nYou can now register for this event. Registration will close at 14:0 0 on 21st October.\nThis event is \;free of charge \;to both Membe rs and Non Members of PSI.\nTo register your place\, please \;click he re.\nOverview\nPSI\, the European Federation of Statisticians in the Pharm aceutical Industry (EFSPI) and the Biopharmaceutical Section of the Americ an Statistical Association (ASA) are jointly organising a webinar on Compl ex Innovative Designs (CID) in practice. \; Speakers from regulatory a uthorities and industry will present on their experience\, which will incl ude the following aspects:\n \;\n&bull\; Overview of the FDA Complex I nnovative Trial Design pilot program and the applications received to date together with details on some of them\n&bull\; Overview of the FDA guidan ce on interacting on Complex Innovative Trial Designs\n&bull\; Detailed ca se study of a clinical trial in children which was evaluated within FDA&rs quo\;s CID pilot program\, applying borrowing of information from external trials in adults\n&bull\; Overview of statistical and regulatory consider ations on master protocols\, focusing on Phase III confirmatory trials.\nS peaker details\n\n\n\n \n \n \n Speaker\n \n \n Biography\n \n \n \n \n \n John Scott\n (FDA)\n \n \n John Scott is Director of t he Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research\, where he has also served as Deputy Director and as a statis tical reviewer for blood products and for cellular\, tissue and gene thera pies. 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 cl inical trial design and analysis\, drug and vaccine safety\, data and text mining\, and benefit-risk assessment. He is the CBER lead for 21st Centur y Cures and PDUFA VI efforts in Complex and Innovative Trial Design\, co-c hairs the CID Pilot Program\, and was the lead author of the guidance docu ment Interacting with the FDA on Complex Innovative Trial Designs for Drug s and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from t he University of Pittsburgh\, an M.A. in Mathematics from Washington Unive rsity in St. Louis\, and a B.A. in Liberal Arts from Sarah Lawrence Colleg e. He is a Fellow of the American Statistical Association and is past Edit or of the journal\, Pharmaceutical Statistics.\n \n \n \n \n \n Olivier Collignon\n (GSK)\n \n \n Dr Olivier Collignon w orks as Statistics Leader at GSK in the United Kingdom where he contribute s to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in bask et\, umbrella and platform trials\, use of historical controls and clinica l prediction models. He previously worked as a biostatistician in France a nd 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 sc ientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.\n \n \n \n \n \n Dieter Hä\;ring \n (Novartis)\n \n Dieter A. Hä\;ring\, P hD\, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Grou p Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novar tis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs\, including t he fingolimod (Gilenya)\, siponimod (Mayzent) and ofatumumab (Kesimpta) pr ograms.\n He planned the re-design of the PARADIGMS study\, whi ch was the first successfully completed randomized controlled clinical tri al in pediatric MS and led to the approval of Gilenya in pediatric MS. Cur rently Dieter is working on the NEOS trial\, a study in children with mult iple sclerosis\, which uses a Bayesian design to borrow strength from hist orical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program.\n Prior to jo ining Novartis\, Dieter studied biology and statistics. Dieter holds an MS c in Biology from University of Basel\, Switzerland\; a PhD in Biology fro m ETH Zurich\, Switzerland\; an MSc in Statistics from the University of N euchâ\;tel\, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin\, Ireland. \n \n \n \n Marius Thomas \;\n (Novartis)\n Marius Thomas\, PhD is currently worki ng as a Senior Principal Biostatistician in the Neuroscience development u nit of Novartis. Since joining Novartis\, he has worked on various project s in the area of multiple sclerosis. He is the trial statistician for NEOS \, a study in children with multiple sclerosis\, which uses a Bayesian des ign to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot p rogram.\n Before joining Novartis\, Marius was an early-stage r esearcher in the IDEAS (Improving Design\, Evaluation and Analysis of earl y drug development Studies) European Union training network\, where he wor ked on the development of new approaches for subgroup identification in cl inical trials in close collaboration with the Novartis Statistical Methodo logy Group. Marius holds a PhD in Statistics from TU Dortmund University.\ n \n \n \n\n \; DTEND:20211021T150000Z DTSTAMP:20260807T193219Z DTSTART:20211021T130000Z LOCATION: SEQUENCE:0 SUMMARY:Joint PSI\, EFSPI & ASA BIOP Webinar: Complex Innovative Designs UID:RFCALITEM639217279391277934 X-ALT-DESC;FMTTYPE=text/html:Date: Thursday 21st October 2 021
\nTime: 14:00-16:00 BST
\nLocation: Online
\nSpeakers: \;John Scott \; (FDA)\, \;Olivier Collignon \;(GSK)\, \;Diet er Hä\;ring &\; Marius Thomas \;(Novartis).
\n
\nWho is this event intended for? \;The event is i ntended for statisticians involved in the design of clinical trials in all therapeutic areas\, from industry\, CROs and academia.
\nWha t is the benefit of attending? \;The audience will gain insig ht into regulatory considerations for complex innovative designs and their use in practice. \;
\n

Registration

\n

You can now regi ster for this event. Registration will close at 14:00 on 21st October.
\nThis event is \;free of charge \;to both Members and Non Membe rs of PSI.
\nTo register your place\, please \;click here.

\ n

Overview

\n

PSI\, the European Federation of Statisticians in t he Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of th e American Statistical Association (ASA) are jointly organising a webinar on Complex Innovative Designs (CID) in practice. \; Speakers from regu latory authorities and industry will present on their experience\, which w ill include the following aspects:
\n \;
\n&bull\; Overview of the FDA Complex Innovative Trial Design pilot program and the applicati ons received to date together with details on some of them
\n&bull\; Overview of the FDA guidance on interacting on Complex Innovative Trial De signs
\n&bull\; Detailed case study of a clinical trial in children w hich was evaluated within FDA&rsquo\;s CID pilot program\, applying borrow ing of information from external trials in adults
\n&bull\; Overview of statistical and regulatory considerations on master protocols\, focusin g on Phase III confirmatory trials.

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Speaker details

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Speaker

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Biography

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Johned it
\n John Scott
\n < em>(FDA)

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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 n umerous articles in areas including Bayesian and adaptive clinical trial d esign and analysis\, drug and vaccine safety\, data and text mining\, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PD UFA VI efforts in Complex and Innovative Trial Design\, co-chairs the CID Pilot Program\, and was the lead author of the guidance document Interacti ng with the FDA on Complex Innovative Trial Designs for Drugs and Biologic al Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh\, an M.A. in Mathematics from Washington University in St. L ouis\, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fel low of the American Statistical Association and is past Editor of the jour nal\, Pharmaceutical Statistics.

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Oliv ieredit
\n Olivier Collignon
\n (GSK)

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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 h olds a PhD in Applied Mathematics and is especially interested in basket\, umbrella and platform trials\, use of historical controls and clinical pr ediction models. He previously worked as a biostatistician in France and L uxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 ye ars\, where he gained regulatory experience and participated to the scient ific evaluation of the design and results of clinical trials to obtain mar keting authorization of new drugs in Europe.

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Dieteredit
\n Dieter Hä\ ;ring
\n (Novartis)

\n 		Dieter A. Hä\;ring\, P hD\, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Grou p Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novar tis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs\, including t he fingolimod (Gilenya)\, siponimod (Mayzent) and ofatumumab (Kesimpta) pr ograms.\n

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 pedia tric MS. Currently Dieter is working on the NEOS trial\, a study in childr en with multiple sclerosis\, which uses a Bayesian design to borrow streng th from historical trials in adults and children. The design was extensive ly discussed with the FDA as part of their CID pilot program.

\n Prior to joining Novartis\, Dieter studied biology and statistics. Di eter holds an MSc in Biology from University of Basel\, Switzerland\; a Ph D in Biology from ETH Zurich\, Switzerland\; an MSc in Statistics from the University of Neuchâ\;tel\, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin\, Ireland.
Mariusedit
\n Marius Thomas \;
\n (Novartis)		Marius Thomas\, PhD is curren tly working as a Senior Principal Biostatistician in the Neuroscience deve lopment unit of Novartis. Since joining Novartis\, he has worked on variou s projects in the area of multiple sclerosis. He is the trial statistician for NEOS\, a study in children with multiple sclerosis\, which uses a Bay esian design to borrow strength from historical trials in adults and child ren. The design was extensively discussed with the FDA as part of their CI D pilot program.\n

Before joining Novartis\, Marius was an e arly-stage researcher in the IDEAS (Improving Design\, Evaluation and Anal ysis of early drug development Studies) European Union training network\, where he worked on the development of new approaches for subgroup identifi cation in clinical trials in close collaboration with the Novartis Statist ical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

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