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What is this event about?

Join us for our 6th anuual event, the only Adaptive Designs in Clinical Drug Development conference in the UK!

 

In recent years, the use of adaptive design in clinical trials has been considered an efficient and optimal way of designing clinical trials.

Adaptive design has gradually evolved from a novel idea into a standard norm in the pharmaceutical industry. This new clinical paradigm could change the way traditional clinical trials, with their restrictive guidance, are run today.

With more flexibility, faster development timelines and significant monetary savings, an adaptive design trial is the way forward.

SMi’s 6th annual Adaptive Designs in Clinical Drug Development conference will shine a spotlight on the industry in this rapidly advancing novel technique.
 

 

 

 Why should you attend this event?

Learn from the industry's leading pioneers and take back new approaches to your work!

Key Areas Covered:

 

  • Case studies from leading pharmaceutical companies on their use of adaptive clinical trials
     
  • Maximising the benefits of an adaptive design through effective management
     
  • Adaptive design within a Bayesian framwework
     
  • Tried and tested - case studies of successful adaptive design trials 
  • 'Out with the old, in with the new' - to adapt or not to adapt?

 

 

 

Speakers from this year's event includes:

 • Graeme Archer, Director, Quantitative Sciences – Clinical Statistics, GlaxoSmithKline

• Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca

Sandrine Micallef, Clinical Biostatistics Oncology, Sanofi-Aventis

• Giacomo Mordenti, Senior Expert Biostatistician, Merck Serono

• Barbara Bogacka, Reader in Statistics, Queen Mary, University of London

• Markus Niggli, Project Statistician & Annette Sauter, Project Statistician, Roche

• Prof Christopher Jennison, Professor of Statistics, University of Bath

• Frank Fleischer, Teamleader Clinical Biostatistics, Boehringer Ingelheim

• Pantelis Vlachos, Principal Specialist, Merck

• Edwin Wagena, Vice President, Clinical Development, Kiadis Pharma

• Les Huson, Honorary Lecturer in Medical Statistics, Imperial College London

• Yongming Qu, Research Advisor, Eli Lilly

• Yu Shyr, Professor, Cancer Biostatistics, Vanderbilt University

• Patrick Johnson, Head Global Biometrics, Vifor Pharma

• Eric Silva, Cytel

• Vera Lisovskaja, Department of Mathematical Sciences, Chalmers University of Technology and Göteborg University

  • Professor Andy Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions
 

 

Who should attend this event?

 

Chief Executives, Vice Presidents, Executive Directors, Heads, Senior Scientists, Team Leaders of:

 

  • Biostatistics
  • Adaptive Trials
  • Trial Design
  • Drug Development
  • Clinical Trials
  • Regulatory Affairs
  • Drug & Safety Assessment
  • Data Management
  • Drug Supply
  • Logistics
  • Clinical Research
  • Clinical Statistics
  • Contract Research

 

Fancy speaking at the conference?  Do you know of anyone who may be interested in speaking?  We are always on the look-out for new speakers for our upcoming conferences.  Let us know - contact the Conference Producer.

For sponsorship and exhibiting opportunities,contact our Sponsorship Department

 

 

Participants from Other Conferences in this Series Have Come from Organizations Including: 

  • Abbott Laboratories
  • Amgen
  • AstraZeneca
  • Bayer 
  • Boehringer Ingelheim 
  • Bristol-Myers Squibb 
  • Celgene
  • Cephalon
  • Cytel
  • Eli Lilly 
  • FDA
  • Genentech
  • Genzyme
  • GlaxosmithKline
  • Grunenthal Gmbh 
  • Johnson & Johnson
  • Merck & Co
  • Novartis
  • Novo Nordisk
  • Orion Pharma
  • Pfizer 
  • Queen Mary University London
  • Roche 
  • Sanofi-Aventis
  • Shire 
  • Tessella
  • Wyeth

 

   

 


 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Robert Clay

Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca

9:10 Adaptive designs so far: how far have we come?

Frank Fleischer

Frank Fleischer, Teamleader Clinical Biostatistics, Boehringer-Ingelheim

  • The future outlook of adaptive clinical trials
  • Current trends and recent developments in use of adaptive designs
  • Moving forward: strategies for successful adaptive clinical trials
  • 9:50 Combining information for adaptive dose selection in early phase trials

  • Two applications in multiple ascending dose studies using Bayesian models
  • Optimally integrating safety and efficacy data across studies from healthy volunteers and patients
  • How to reduce sample size/proportion of overdosed, while making informed decision for subsequent studies

     

  • Markus Niggli

    Markus Niggli, Project Statistician, Roche

    Annette Sauter

    Annette Sauter, Project Statistician, Roche

    10:30 Morning Coffee

    10:50 Implementing adaptive designs: current technology to protect trial integrity Reduce operational bias and build regulatory confidence

    Eric Silva

    Eric Silva, Manager of Enterprise and Hosted Solutions , Cytel

    11:30 Efficient adaptive design for early clinical trials

    Barbara Bogacka

    Barbara Bogacka, Reader in Statistics, Queen Mary, University of London

  • Criteria of efficiency 
  • Incorporating PK/PD data into the adaptive decisions 
  • Maximising information from the trial ethically
  • 12:10 Consulting and collaboration: Factors for successfully designing an adaptive trial

    Jurgen Hummel

    Jurgen Hummel, Associate Statistical Science Director, PPD

  • Many stakeholders (internal or external) only consider fixed study designs
  • Case study is used to illustrate how to overcome perceptions about adaptive designs and win over stakeholders, covering:
  • Consulting services for a small early stage biotechnology company to make development plan more efficient by including several adaptive design elements
  • Collaboration with Berry Consultants provided relevant simulations and expertise for successful Pre-IND meeting with FDA
  • 12:50 Networking Lunch

    13:50 Dose finding in oncology: a Bayesian model based approach

    Pantelis Vlachos

    Pantelis Vlachos, Principal Specialist, Merck Serono

  • Utilise historical data and expert opinion to obtain a ‘best guess’ for the dose-toxicity curve 
  • Update model through MCMC
  • Simulate course of progress through different scenario and compare with ‘standard designs’
  • 14:30 Phase II adaptive design: worked example using prior data and optimal design theory

    Patrick  Johnson

    Patrick Johnson, Head Global Biometrics, Vifor Pharma

  • Understanding the main aims of Phase II including characterising dose-response and appropriate dose-selection
  • Adaptive designs based on dose re-selection after collecting some initial data appear attractive: analysing the potential benefits
  • Revealing more about an adaptive design that addresses the following issues:
    1. Initial dose-selection
    2. Parametric model fitting to interim data supported with prior data from a drug with the same MOA
    3. Final stage doses and sample size selected using optimal design theory

     

  • 15:10 Adaptive dose finding incorporating patient choices

    Les Huson

    Les Huson, Honorary Lecturer in Medical Statistics , Imperial College London

  • Patients vary in their tolerance of adverse events
  • Patients and physicians may wish to choose doses based on individual tolerance
  • Adaptive dose finding methods could incorporate this choice
  • 15:50 Afternoon Tea

    16:10 An over-arching approach to designing Phase II and Phase III trials

    Christopher Jennison

    Christopher Jennison, Professor of Statistics, University of Bath

  • Assessing the probability of success after Phase II results
  • Optimising dose and sample size for a Phase III trial
  • A Bayes theory decision framework for jointly planning Phase II and Phase III trials
  • 16:50 Panel discussion: To adapt or not to adapt? Adaptive designs versus conventional trials

    Though adaptive designs have been around for decades, only in relatively recent times, since the FDA‘s  "Critical Path Opportunities Report" of  2006, has there been a concerted effort by the pharmaceuticals industry to adopt these ideas. As companies embrace these techniques, a critical question is whether to pursue a strategy that may reduce trial times significantly, but with the risk of more complex logistics and regulatory review, or to use a more conventional strategy with traditional clinical trials. This panel discussion will focus on the pros and cons of these two approaches.

    Christopher Jennison

    Christopher Jennison, Professor of Statistics, University of Bath

    Robert Clay

    Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca

    Les Huson

    Les Huson, Honorary Lecturer in Medical Statistics , Imperial College London

    17:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Graeme Archer

    Graeme Archer, Director, Quantitative Sciences - Clinical Statistics, GlaxoSmithKline

    9:10 Bayesian approach for Futility Adaptive Design with Time to Event Endpoints

    Giacomo Mordenti

    Giacomo Mordenti, Senior Expert Biostatician , Merck Serono

  • Understanding Bayesian adaptive designs
  • Assessing  when a Bayesian adaptive design is useful
  • Identifying effective interim analysis futility stopping rules
  • 9:50 The challenges of the high-density biomarker adaptive trials

    Yu Shyr

    Yu Shyr, Professor, Cancer Biostatistics, Vanderbilt University

  • Understanding high-density biomarker data
  • Designing high-density biomarker trials including the sample size estimation
  • Implementing high-density biomarker trial
  • 10:30 Morning Coffee

    11:00 Escalation with overdose control for bivariate outcomes (safety and activity) in early oncology clinical trials

    Sandrine Micallef

    Sandrine Micallef, Senior Biostatistician, Sanofi-Aventis R&D

  • Bayesian model-based adaptive design taking into account both safety and activity criteria for dose escalation and dose finding
  • Model involves a monotonous dose-toxicity curve and a flexible (potentially non monotonous) dose-activity curve
  • Dose escalation and dose-finding rules based on a clinically relevant level of efficacy and a controlled overdose risk
  • The proposed design can address the dose-finding issues for both cytotoxic compounds and Molecularly Targeted Agents
  • 11:40 Adaptive clinical trials for rare disease medicine development

    Graeme Archer

    Graeme Archer, Director, Quantitative Sciences - Clinical Statistics, GlaxoSmithKline

  • Rare Disease clinical development is challenging, due to the rareness of the condition.
  • Often active comparators don’t exist, while randomisation to placebo can pose ethical difficulties.
  • Statistical thinking – in terms of inference, as well as (mostly) adaptive trial design – is more important in smaller studies than is the case in traditional, “huge” Phase 3 programmes.
  • The talk will give some examples of the approaches being developed at GSK Rare Diseases
  • 12:20 Adaptive Designs: Why are they not used more ?

    Anthony Fox

    Anthony Fox, President, EBD Consulting

  • Fallacy 1: Adaptive designs are new and therefore not well-understood
  • Fallacy 2: Choosing whether to propose an adaptive design for a particular clinical trial (and if so, then which) has no simple method to it
  • Fallacy 3: Adaptive designs are OK for the academics, but have little regulatory / development practicality when it's for-profit product development
  • 12:50 Networking Lunch

    13:50 Panel Discussion: Potential roadblocks to effective implementation of adaptive trials

    Andy Grieve

    Andy Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions

  • What are the practical barriers to adaptive trial implementation in Pharma Companies
  • How will these change in the future
  • 14:30 Technologies and processes for the implementation of adaptive clinical trials

    Andy Grieve

    Andy Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions

  • Understand the requirements for successful implementation of adaptive trials
  • Learn about the technologies that are essential to achieve effective implementation
  • 15:10 Adaptive sequential designs for subgroup selection

    Baldur Magnusson

    Baldur Magnusson, Statistician, Novartis AG

  • Statistical and practical considerations for subgroup analysis in confirmatory studies
  • Comparison between different design approaches; fixed vs. flexible adaptation
  • 15:50 Afternoon Tea

    16:10 On the choice of doses in phase III clinical trials

  • Modeling probability of success in the later phases of clinical trials
  • Optimizing the number of doses after a benefit/risk criterion
  • Vera Lisovskaja

    Vera Lisovskaja, Department of Mathematical Sciences , Chalmers University Of Technology

    16:50 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    The Bayesian Adaptive Design Process: Components, Teamwork and Simulation
    Workshop

    The Bayesian Adaptive Design Process: Components, Teamwork and Simulation

    The Grange Holborn Hotel
    28th March 2012
    London, United Kingdom

    The Grange Holborn Hotel

    50-60 Southampton Row
    London WC1B 4AR
    United Kingdom

    The Grange Holborn Hotel

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