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Adaptive Designs are the future for clinical trials.

Adaptive Design techniques already have had notable successes in cutting the costs of clinical trials and times to market for drugs. But despite their phenomenal potential, uncertainty still remains as to appropriate implementation, best practice, and the regulatory framework. SMi's 2nd Annual conference on Adaptive Designs in Clinical Drug Development will showcase presentations from leaders in this exciting and profitable area, and provide the perfect environment to network with fellow delegates with an interest in the field.

This event will cover the realities of adaptive clinical trials; from looking at the technology and infrastructure needed, to choosing and applying the right model according to the aims of the trial; from potential pitfalls in implementation, to a number of examples from real clinical trials.

Key issues to be discussed will include:

  • Focus on the latest technology and infrastructure for adaptive trials
  • Learning and Confirming with adaptive trials
  • Adaptive design in early phase drug development
  • A closer look at some of the latest statistical models
  • Numerous Case Studies from top pharmaceutical companies

**NEW TOP SPEAKERS CONFIRMED!**

  • Richard Young, Director of Business Development, CMED Research
  • Nitin Patel, Co-Founder, Chairman and CTO, Cytel
  • Cyrus Mehta, President and Co-Founder, Cytel
  • Bill Byrom, Vice President, Product Strategy, Clinphone

Confirmed Speakers:

  • James Matcham, Biostatistics Director, Amgen
  • Bruno Boulanger, Head, Exploratory Statistics, UCB Pharmaceuticals
  • Alex Bajamonde, Director, Early & Business Development, DATA Group, Genentech
  • Surya Mohanty, Senior Director, Biometrics and Clinical Informatics, Johnson and Johnson PRD
  • Tom Parke, Head of Clinical Trials Solutions, Tessella
  • Yu Shyr, Professor and Chief, Division of Cancer Biostatistics, Vanderbilt University
  • Judith Quinlan, Director of Statistics, Biopharm CEDD, GSK
  • Michael Borkowski, General Manager Of Clinical Technologies, United Biosource Corporation
  • Francois Vandenhende, CEO, ClinBAY
  • Melissa Spann, Research Scientist, Neuroscience statistics, Eli Lilly
  • Alun Bedding, Biostatistics and Programming Development Partners, Drug Development Sciences, GSK
  • Inna Perevoszkaya, Clinical Biostatistics, Merck & Co.
  • Stuart Pocock, Medical Statistics Unit, London School of Hygiene and Tropical Medicine
  • Rhian Jones, Clinical Pharmacy Coordinator I, Wyeth
  • Steve Pascoe, Global Head, Respiratory/ Dermatology Profiling Exploratory Clinical Development, Novartis

This event is aimed at all those involved in implementing clinical trials, or associated statistical work. This includes those working in:

Biostatistics, Clinical R&D, Medical Affairs, Clinical Operations, Clinical Supplies, Data Management, Portfolio Management, and Regulatory Affairs

Conference programme

8:30 Registration & Coffee

9:00 Chairperson's Opening Remarks

Alun Bedding

Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

9:10 ADAPTIVE DESIGN AND THE FUTURE

Alun Bedding

Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

  • Will all trials be adaptive?
  • The pipeline in the 21st century
  • Changing business paradigms and drug development
  • 9:50 ADAPTIVE DESIGN IN EARLY PHASE DRUG DEVELOPMENT

    Steve Pascoe

    Steve Pascoe, Global Head Respiratory/ Dermatology Profiling Exploratory Clinical Development, Novartis

  • Maximum information can be acquired in minimum time by the use of adaptive designs in the exploratory setting
  • The benefits will be demonstrated by real examples
  • 10:30 Morning Coffee

    11:00 THE ROLE OF SIMULATION IN ADAPTIVE TRIAL DESIGN AND MEDICATION SUPPLY ESTIMATION

  • Practical use of simulation as a tool to determine the value of employing an adaptive design, and optimizing study design characteristics
  • Integrating study simulation and supply chain simulation to estimation clinical supply requirements for adaptive designs
  • Nitin Patel

    Nitin Patel, Founder, Chairman and CTO, Cytel Inc

    Bill Byrom

    Bill Byrom, Vice President, Product Strategy, ClinPhone Group Ltd

    11:40 MERCK & CO. CASE STUDY

    Inna  Perevozskaya

    Inna Perevozskaya, Senior Statistical Scientist, Clinical Biostatistics, Merck & Co

  • Lessons from Merck's latest adaptive trials - details to be confirmed
  • 12:20 Networking Lunch

    13:50 SELECTING AND IMPLEMENTING AN ADAPTIVE TRIAL DESIGN

    Michael Borkowski

    Michael Borkowski, General Manager Of Clinical Technologies, United BioSource Corporation (UBC)

  • Learn which studies are best suited for an adaptive trial design
  • Understand the key benefits associated with an adaptive trial design
  • Identify the planning and logistical considerations throughout all phases of the study
  • Explore the key role technology plays in successful adaptive trials
  • Review methods for ensuring data is unbiased and maintains integrity
  • 14:30 BAYESIAN ADAPTIVE NON-INFERIORITY DESIGN WITH SAFETY ASSESSMENT: RETROSPECTIVE ANALYSIS OF CLINICAL TRIAL DATA

    Melissa Spann

    Melissa Spann, Research Scientist, Neuroscience Statistics, Eli Lilly

  • Bayesian assessment of non-inferiority of an experimental treatment to an existing treatment; including placebo data in the model
  • Joint posterior predictive probabilities of safety and efficacy to determine adaptive allocation probabilities
  • Eliciting priors from research physicians
  • Simulations and application to clinical data
  • Implications for patients
  • 15:10 Afternoon Tea

    15:40 ADAPTIVE TRIAL DESIGN - REALISING THE POTENTIAL

    Richard Young

    Richard Young, Director of Business Development, Cmed Ltd

  • The practical execution of ATD studies requires near real time data acquisition/ management from both the clinic and laboratory.
  • The ability to guide ATD study progress through timely decision making and then (1) facilitate any appropriate protocol amendments and (2) adjust the clinical data acquisition requirements in a site specific way enables the conduct of studies using this methodology.
  • Case studies will presented of how this has been achieved and the lessons learned.
  • 16:20 BALANCED TWO-STAGE DESIGN FOR PHASE II CLINICAL TRIALS WITH CORRELATED OUTCOMES

    Yu Shyr

    Yu Shyr, Professor and Chief, Division of Cancer Biostatistics, Vanderbilt University

  • Oncology phase II clinical trials are often designed using Simon’s two-stage designs (Optimal and “Minimax”) for independent observations.
  • Simon’s designs do not include the use of correlated observations, and do not balance the sample sizes of the two stages.
  • In Simons’ designs, the sample sizes of the two stages can be highly unequal.  In certain circumstances, an alternative design option that balances the sample sizes is desirable.
  • We proposed the two-stage phase II design that balances the sample sizes of the first and the second stages with the correlated observations, while controlling for type I and type II error rates.
  • The comparisons between the balanced two-stage design and other two-stage designs, e.g., Bayesian two-stage design will be discussed
  • 17:00 ADAPTIVE DESIGNS: INSIGHTFULLY INNOVATIVE OR IRRELEVANTLY IMPRACTICAL?

    Stuart Pocock

    Stuart Pocock, Professor of Medical Statistics, London School of Hygiene and Tropical Medicine

  • The pros and cons of using adaptive designs in major Phase III trials
  • Sample size re-estimation and seamless phase II/III designs critically assessed
  • Recent examples of major trials illustrating the main themes
  • 17:40 Chairperson’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairperson's Opening Remarks

    James Matcham

    James Matcham, Biostatistics Director, Amgen

    9:10 ADAPT TO LEARN, OR ADAPT TO CONFIRM?

    James Matcham

    James Matcham, Biostatistics Director, Amgen

  • Categorising adaptive trial design options
  • Adaptive trial design to inform development decisions
  • Can an adaptive trial be confirmatory?
  • 9:50 LEARNING WITH ADAPTIVE DESIGNS: A ROUTE TO MAKE MODEL BASED DRUG DEVELOPMENT A REALITY

    Bruno Boulanger

    Bruno Boulanger, Head, Exploratory Statistics, UCB

  • Bayesian Adaptive Designs are particularly well adapted to serve learning phase studies and objectives.
  • Bayesian Adaptive Designs force you to clarify the development strategy and the objectives of every study; they also focus attention on the parameters to permit MBDD.
  • In early phases, a priori information is limited by definition, and so Bayesian Adaptive Designs are designed to cope with this uncertainty.
  • From a logistical point of view, Bayesian Adaptive Designs are also easier to implement in early phases.
  • 10:30 Morning Coffee

    11:00 DECIMAKER (TM): STATISTICAL SOFTWARE PACKAGE FOR ADAPTIVE DESIGN AND DECISION ANALYSIS

    Francois Vandenhende

    Francois Vandenhende, CEO and Executive Consultant, ClinBAY

  • Discover powerful Bayesian methods for trial modeling, adaptation and decisions.
  • Learn how to combine trial simulation and implementation in a single user-friendly interface.
  • Estimate in real-time the probability of success and decide dynamically on best course of action for your studies.
  • See benefits from real-case phase I and II studies and assess the value of DecimakerTM for your business.
  • 11:40 HOW TO DEPLOY ADAPTIVE CLINICAL TRIALS

    Tom Parke

    Tom Parke, Associate Director, Software Development, Tessella Support Services Plc

  • Running a trial adaptively can sometimes seem like the established clinical trial "play book" has to be stood on its head.
  • What are the main differences from conventional trials that have to be addressed?
  • What have been the most effective means of addressing these differences?
  • What have been the main problems in practice that we have encountered so far in running adaptive clinical trials?
  • How do we see the practice of adaptive clinical trials moving forward?
  • 12:20 Networking Lunch

    13:50 A PRACTICAL GUIDE TO DATA MONITORING COMMITTEES

    Alex Bajamonde

    Alex Bajamonde, Director, Early & Business Development, DATA Group, Genentech

  • The DMC’s new role in the era of adaptive trials
  • How to ensure clear divisions of responsibility
  • “Firewalls” – ensuring study blind in particular, study integrity in general
  • Actions – recommendations versus decisions, timing, in scope versus out of scope
  • 14:30 DESIGN AND IMPLEMENTATION OF LATE-STAGE CONFIRMATORY ADAPTIVE TRIALS

    Cyrus Mehta

    Cyrus Mehta, President and Co-Founder, Cytel Software Corporation

  • Preservation of type-1 error
  • Power, parameter estimation
  • Multiple testing
  • Population enrichment
  • The crucial role of simulation
  • Creating an adaptive interim analysis charter to protect the study from biases
  • 15:10 Afternoon Tea

    15:40 GSK CASE STUDY – ACUTE MIGRAINE POC USING CRM

    Judith Quinlan

    Judith Quinlan, Director of Statistics, Biopharm CEDD, GlaxoSmithKline Research & Development

  • The theoretical debate around barriers to implementation of adaptive designs
  • An early phase study as an example to increase our understanding of these issues
  • A phase II POC study in acute migrane
  • The challenges of a CRM method
  • Solutions to implementation – including the infamous “who saw what when” question
  • 16:20 WYETH CASE STUDY - DRUG SUPPLY AND LOGISTICS IN AN ADAPTIVE TRIAL

    Rhian Jones

    Rhian Jones, Clinical Pharmacy Coordinator I, Wyeth

  • Randomization and packaging strategies
  • Distribution strategies
  • Estimating and forecasting clinical trial supplies
  • Project team roles and responsibilities
  • Lessons learnt
  • 17:00 Chairperson’s Closing Remarks and Close of Day Two

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    Workshops

    Adaptive Group Sequential Designs for Clinical Trials
    Workshop

    Adaptive Group Sequential Designs for Clinical Trials

    The Hatton, at etc. venues
    5th February to 6th February 2008
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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