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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
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.
Registration
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.
Overview
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.
Speaker details
Speaker
Biography
John Scott (FDA)
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.
Olivier Collignon (GSK)
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.
Dieter Häring (Novartis)
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.
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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