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Conference Documentation: Adaptive Designs in Clinical Trials

Conference Documentation: Adaptive Designs in Clinical Trials

SMi is proud to present its 8th Annual conference on Adaptive Designs in Clinical Trials taking place on 18th - 19th April in London

In recent years, the use of adaptive design methods has become very popular due to its flexibility for identifying clinical benefits of the testing drug. Adaptive designs offer the potential to reduce timelines and patient exposure while maximising the probability for successful outcomes. However, along with these benefits come challenges: additional complexity, needs for advanced statistical models and increased operational demands.

The 8th annual Adaptive Clinical Trials conference is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, regulatory issues associated with adaptive design, and more.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
Explore the use of adaptive design methods in clinical trials
Adapt clinical development for immunotherapies in oncology
Evaluate adaptive designs and Bayesian statistic
Improve covariant adaptive designs
Seamless Phase I/II Dose Finding Designs with Efficacy and Safety Endpoints


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Loic Darchy, Senior Statistician, Sanofi Aventis
9:10
Adaptive Designs in Practice
Frank Fleischer, Principal Methodology Statistician, Boehringer-Ingelheim
9:50
Seamless phase I/II dose finding designs with efficacy and safety endpoints
Alex Sverdlov, Associate Director of Biostatistics at EMD Serono, EMD Serono, Inc
10:30
Morning Coffee
11:00
Biomarker driven early phase oncology trials; opportunities and challenges
Sidath Katugampola, Biomarker Development Specialist, Cancer Research UK
11:40
Panel discussion: The role of biomarker-driven adaptive designs in clinical development
Loic Darchy, Senior Statistician, Sanofi Aventis
11:40
Panel discussion: The role of biomarker-driven adaptive designs in clinical development
Alex Sverdlov, Associate Director of Biostatistics at EMD Serono, EMD Serono, Inc
12:20
Networking Lunch
13:30
Opportunities of adaptive enrichment designs in the era of precision medicine
Bo Huang, director of biostatistics, Pfizer Global Pharmaceuticals
14:10
Designing and planning seamless Phase 2/3 studies: Tools, justification and a case-study
Tom Parke, Director of Software Solutions, Berry Consultants, LLP
14:50
Afternoon Tea
15:20
Adaptive clinical trials: A DSMB perspective
Bruce Turnbull, Professor of Statistics, Cornell University
16:00
Optimising clinical trials in neuroscience
Richard Wyse, Director of Research and Development, The Cure Parkinsons Trust
16:40
Point estimates and confidence intervals for phase II/III clinical trials when multiple endpoints are used to make treatment selection
Peter Kimani, Assistant Professor in Medical Statistics, Warwick Medical School
17:20
Sequential design for a categorical endpoint in a single-arm clinical trial: application to tumor response
Pierre Colin, Statistical sciences and modelling, Sanofi Pharma
18:00
Chairman’s Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Alex Sverdlov, Associate Director of Biostatistics at EMD Serono, EMD Serono, Inc
9:10
Adaptive designs in proof-of-concept studies (Phase IIa) and dose-finding studies (Phase IIb)
Philip Hougaard, Senior Specialist, Biostatistics, H. Lundbeck A/S
9:50
Be adaptive: bright hope or buzz word? A mid-size company perspective
10:30
Morning Coffee
11:00
Early dialogue with regulatory agencies during development and impact on programme and study design
Robert Clay, Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA, Highbury Regulatory Science?
11:40
Adaptive designs and Bayesian statistic
Sophie Carr, Bayesian Analyst, Bays Consulting
12:20
Networking Lunch
13:15
Seamless phase II/III designs - challenges and opportunities
Fredrik Ohrn, Statistical Science Director, AstraZeneca
13:55
Improving adaptive designs
Christopher Jennison, Professor of Statistics, University of Bath
14:35
Software solutions for exploratory and confirmatory trials
Silke Jörgens, Senior Statistical Consultant, ICON Clinical Research
15:15
Afternoon Tea
15:45
Improving covariate-adaptive designs
Steve Coad, Reader in Statistics, Queen Mary, University of London
16:25
Adaptive designs in clinical trials from scientific advice to marketing authorisation: lessons learnt from submissions to the European Medicine Agency
Olivier Collignon, Statistics consultant, European Medicines Agency (EMA)
17:5
Smart and Living Implant Equipped with Active therapeutics and Stem cells for Regenerative NanoMedicine
Nadia Jessel, Research director, INSERM
17:45
Diagnosis and treatment of neurodegenerative dementia: a clinical dilemma
Filippo Baldacci, Medical Doctor, Neurologist , University of Pisa
18:25
Chairman’s Closing Remarks and Close of Day Two

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