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Adaptive Designs in Clinical Trials
18 April - 19 April 2016
Adaptive Designs in Clinical Trials

SAE Media Group 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

FEATURED SPEAKERS

Alex Sverdlov

Alex Sverdlov

Associate Director of Biostatistics, EMD Serono, Inc

Alex Sverdlov

Associate Director of Biostatistics, EMD Serono, Inc
Alex Sverdlov

Bo Huang

Director of Biostatistics, Pfizer Global Pharmaceuticals
Bo Huang

Bruce Turnbull

Professor of Statistics, Cornell University
Bruce Turnbull

Christopher Jennison

Professor of Statistics, University of Bath
Christopher Jennison

Filippo Baldacci

Medical Doctor, Neurologist , University of Pisa
Filippo Baldacci

Frank Fleischer

Principal Methodology Statistician, Boehringer-Ingelheim
Frank Fleischer

Fredrik Ohrn

Statistical Science Director, AstraZeneca
Fredrik Ohrn

Loic Darchy

Senior Statistician, Sanofi Aventis
Loic Darchy

Nadia Jessel

Research Director, INSERM
Nadia Jessel

Olivier Collignon

Statistics consultant, European Medicines Agency (EMA)
Olivier Collignon

Peter Kimani

Assistant Professor in Medical Statistics, Warwick Medical School
Peter Kimani

Philip Hougaard

Vice President, Biometrics, H. Lundbeck A/S
Philip  Hougaard

Pierre Colin

Statistical Sciences and Modelling, Sanofi Pharma
Pierre Colin

Richard Wyse

Director of Research and Development, The Cure Parkinsons Trust
Richard Wyse

Robert Clay

Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA, Highbury Regulatory Science
Robert Clay

Sidath Katugampola

Biomarker Development Specialist, Cancer Research UK
Sidath Katugampola

Silke Jörgens

Senior Statistical Consultant, ICON Clinical Research
Silke Jörgens

Sophie Carr

Bayesian Analyst, Bays Consulting
Sophie Carr

Steve Coad

Reader in Statistics, Queen Mary, University of London
Steve  Coad

Tom Parke

Director of Software Solutions, Berry Consultants, LLP
Tom Parke

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Loic Darchy

Loic Darchy, Senior Statistician, Sanofi Aventis

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9:10

Adaptive Designs in Practice

Frank Fleischer

Frank Fleischer, Principal Methodology Statistician, Boehringer-Ingelheim

  • Case studies of adaptive designs in practice
  • Transforming a Phase II trial into a Phase II/III adaptive design
  • Usage of historical and within trial information for decision making
  • Adaptive trial examples in the early phase
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    9:50

    Seamless phase I/II dose finding designs with efficacy and safety endpoints

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

  • Advantages of pursuing seamless phase I/II trial designs in the oncology setting
  • Optimal and sequential adaptive designs to achieve experimental objectives of phase I/II trials
  • A simulation study to compare various state-of-the-art phase I/II designs for bivariate binary efficacy-toxicity outcomes
  •  Incorporating covariates to enable personalized dose-finding
  • Statistical software, information technology, and regulatory aspects
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    10:30

    Morning Coffee

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    11:00

    Biomarker driven early phase oncology trials; opportunities and challenges

    Sidath Katugampola

    Sidath Katugampola, Biomarker Development Specialist, Cancer Research UK

  • Pharmacodynamic biomarkers in early phase trials
  • Immune monitoring
  • Challenges in biomarker driven trials
  • clock

    11:40

    Panel discussion: The role of biomarker-driven adaptive designs in clinical development

    Loic Darchy

    Loic Darchy, Senior Statistician, Sanofi Aventis

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

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    12:20

    Networking Lunch

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    13:30

    Opportunities of adaptive enrichment designs in the era of precision medicine

    Bo Huang

    Bo Huang, Director of Biostatistics, Pfizer Global Pharmaceuticals

  • Opportunities and challenges in the era of biomarker-driven targeted therapies
  • Overview of enrichment designs in statistical literature
  • Case study 1: Bayesian predictive probability design for a phase 2 POC study
  • Case study 2: Adaptive enrichment with sample size re-estimation for a phase 3 oncology study
  • clock

    14:10

    Designing and planning seamless Phase 2/3 studies: Tools, justification and a case-study

    Tom Parke

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • Seamless phase 2/3 adaptive trials - the mother lode of adaptive trial design?
  • Elements of a seamless phase 2/3 design - new aspects to adaptive trial simulation
  • Is it worth it? Comparing the value of different drug development strategies
  • Case study: AWARD 5 the Eli Lilly Dulaglutide study
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    14:50

    Afternoon Tea

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    15:20

    Adaptive clinical trials: A DSMB perspective

    Bruce Turnbull

    Bruce Turnbull, Professor of Statistics, Cornell University

  • A series of vignettes will be presented based on the speaker’s experiences from serving on the DSMB for adaptive trials.
  • Pitfalls that may occur during the conduct of an adaptive trial; how they might be avoided.
  • How members with differing interests interact at DSMB meetings with each other, with the sponsor, with a CRO, and with a "firewall"
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    16:00

    Optimising clinical trials in neuroscience

    Richard Wyse

    Richard Wyse, Director of Research and Development, The Cure Parkinsons Trust

  • Adaptive designs in neurology
  • Integrating new biomarkers into clinical development
  • Developing new strategies for testing multiple therapeutics
  • clock

    16:40

    Point estimates and confidence intervals for phase II/III clinical trials when multiple endpoints are used to make treatment selection

    Peter Kimani

    Peter Kimani, Assistant Professor in Medical Statistics, Warwick Medical School

  • Multi-arm and multi-stage
  • Treatment selection
  • Multiple endpoints
  • Point estimation
  • Confidence intervals
  • clock

    17:20

    Sequential design for a categorical endpoint in a single-arm clinical trial: application to tumor response

    Pierre Colin

    Pierre Colin, Statistical Sciences and Modelling, Sanofi Pharma

  • Sequential design
  • Single-arm Phase II clinical trial in oncology
  • Categorical endpoint
  • clock

    18:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

    clock

    9:10

    Adaptive designs in proof-of-concept studies (Phase IIa) and dose-finding studies (Phase IIb)

    Philip  Hougaard

    Philip Hougaard, Vice President, Biometrics, H. Lundbeck A/S

  • Simultaneously doing proof-of-concept and finding the dose(s) for future studies
  • Finding the single best dose or a treatment window with several acceptable doses?
  •  Choosing the most informative doses or the most promising doses (the conflict between individual and collective ethics)?
  • Joint consideration of efficacy and safety
  • clock

    9:50

    Early dialogue with regulatory agencies during development and impact on programme and study design

    Robert Clay

    Robert Clay, Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA, Highbury Regulatory Science

  • Facilitate the development of therapeutics that are available to all patients across the EU
  • Increase early dialogue between different stakeholders
  • Increase patients' involvement
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    10:30

    Morning Coffee

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    11:00

    Adaptive designs and Bayesian statistic

    Sophie Carr

    Sophie Carr, Bayesian Analyst, Bays Consulting

  • Sub group analysis
  • Challenges of sample size estimation
  • The design of Bayesian Methods in clinical trials
  • clock

    11:40

    Seamless phase II/III designs - challenges and opportunities

    Fredrik Ohrn

    Fredrik Ohrn, Statistical Science Director, AstraZeneca

     

  • Case study of a phase II/III trial in oncology
  • Control of type I error
  • Efficiency gains vs operational complexity
  • clock

    12:20

    Networking Lunch

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    13:30

    Improving adaptive designs

    Christopher Jennison

    Christopher Jennison, Professor of Statistics, University of Bath

  • Decision making during an adaptive design
  • Deriving an efficient rule for sample size modification
  • Optimising adaptive designs with treatment selection or subset selection
  • Assessing the benefits of an adaptive design – when are these worthwhile?
  • clock

    14:10

    Software solutions for exploratory and confirmatory trials

    Silke Jörgens

    Silke Jörgens, Senior Statistical Consultant, ICON Clinical Research

  • ADDPLAN BASE/MC/PE for confirmatory trials, including comparisons of multiple treatments against control and subgroup selection at interim analyses
  • ADDPLAN DF for exploratory trials, including dose escalation methods and MCPMod
  • Future plans
  • clock

    14:50

    Improving covariate-adaptive designs

    Steve  Coad

    Steve Coad, Reader in Statistics, Queen Mary, University of London

  • The elements of covariate-adaptive randomisation
  • Maintaining the type I error rate
  • Likelihood-based inference following the designs
  • Marginal and global balance
  • Incorporating information on responses
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    15:30

    Afternoon Tea

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    15:50

    Adaptive designs in clinical trials from scientific advice to marketing authorisation: lessons learnt from submissions to the European Medicine Agency

    Olivier Collignon

    Olivier Collignon, Statistics consultant, European Medicines Agency (EMA)

  • Presentation of several EMA case studies
  • Analysis of the adaptive elements used in the design and their impact on trial success
  • Analysis of time from scientific advice to approval for those products
  • Impact of the scientific advice on the design
  • Discussion of the potential regulatory concerns
  • clock

    16:30

    Smart and living implant equipped with active therapeutics and stem cells for regenerative nano-medicine

    Nadia Jessel

    Nadia Jessel, Research Director, INSERM

  • Nanoreservoirs technology for regenerative medicine
  • Active and living implant for osteoarticular regenerative nanomedicine
  • Bone and cartilage regeneration

     

     

  • clock

    17:10

    Diagnosis and treatment of neurodegenerative dementia: a clinical dilemma

    Filippo Baldacci

    Filippo Baldacci, Medical Doctor, Neurologist , University of Pisa

  • Overview and classification of degenerative dementia
  • Diagnosis and overlaps of degenerative dementias
  • Vascular cognitive impairment and its relationship with degenerative dementias
  • Pre-dementia stadium is the ideal target for treatment: When and how
  • clock

    17:50

    Chairman’s Closing Remarks and Close of Day Two


    Associate Director of Biostatistics
    EMD Serono, Inc
    Director of Biostatistics
    Pfizer Global Pharmaceuticals
    Professor of Statistics
    Cornell University
    Professor of Statistics
    University of Bath
    Medical Doctor, Neurologist
    University of Pisa
    Principal Methodology Statistician
    Boehringer-Ingelheim
    Statistical Science Director
    AstraZeneca
    Senior Statistician
    Sanofi Aventis
    Research Director
    INSERM
    Statistics consultant
    European Medicines Agency (EMA)
    Assistant Professor in Medical Statistics
    Warwick Medical School
    Vice President, Biometrics
    H. Lundbeck A/S
    Statistical Sciences and Modelling
    Sanofi Pharma
    Director of Research and Development
    The Cure Parkinsons Trust
    Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA
    Highbury Regulatory Science
    Biomarker Development Specialist
    Cancer Research UK
    Senior Statistical Consultant
    ICON Clinical Research
    Bayesian Analyst
    Bays Consulting
    Reader in Statistics
    Queen Mary, University of London
    Director of Software Solutions
    Berry Consultants, LLP

    Official Publication

    Supporters

    Preliminary list of 2016 attendees

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    Interview with Silke Jörgens, Senior Statistical Consultant, ICON plc

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    Interview with Alex Sverdlov, Associate Director of Biostatistics, EMD Serono

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