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Following the success of last year’s event, the SMi Group’s third annual conference on Adaptive Designs in Clinical Drug Development promises to be better than ever.

As adaptive designs begin to move from theoretical discussion to practical implementation, SMi’s conference will provide a panel of top speakers whose knowledge and experience will give you the edge in your clinical research. Implementing Bayesian statistical models will impact on every part of your drug development, so it will be vital to understand the implications of this change – from the move towards a “learn and confirm” paradigm and the increasing necessity of using EDC and similar technologies, to the changing regulatory environment and the impact on supplies and randomisation in the trials themselves.

  • DISCOVER the latest adaptive trial designs from key statistical experts
  • LEARN best practice and important tips for implementing an adaptive trial
  • HEAR vital case studies from top pharmaceutical companies
  • UNDERSTAND the impact of adaptive techniques on your pipeline and portfolio
  • OPTIMISE your knowledge of the regulatory challenges for adaptive clinical trials
  • NETWORK with key decision makers and leading specialists

All those involved in biostatistics, clinical research and portfolio management, including directors, heads and vice presidents of:

  • Statistics/Biostatistics
  • Clinical R&D
  • Medical Affairs
  • Clinical Operations
  • Clinical Supplies/Logistics
  • Data Management
  • Portfolio Management
  • Regulatory Affairs
  • Project Management

Last year’s attendees included representatives of the following companies:

  • Abbott
  • Amgen
  • Astellas
  • Boehringer Ingelheim
  • BTG
  • Celgene
  • Dainippon Pharmaceuticals
  • Eli-Lilly
  • Genentech
  • GlaxoSmithKline
  • Ipsen Pharmaceuticals
  • Medimmune
  • Merck & Co.
  • Merck Serono
  • Merz Pharmaceuticals
  • Novartis
  • Teva
  • Sanofi-Sythelabo
  • UCB
  • Wyeth
  • Plus many other delegates from CROs, CTOs, biotechs and academia

For more details about the conference, including information on participating as a speaker or exhibitor, please contact Abigail Worsfold at aworsfold@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

David Manner

David Manner, Group Leader, Exploratory and Programme Medical Statistics, Eli Lilly

9:10 OPENING KEYNOTE – PROGRESS IN IMPLEMENTATION?

Michael  Krams

Michael Krams, Vice President, Adaptive Trials and Applied Program Strategies, Clinical Development., Wyeth Research

  • Is there more talk than action?
  • Some of the latest trials and models
  • The impact of adaptive designs on portfolio management
  • The move to a learn and confirm paradigm
  • Will adaptive designs resolve the pharma industry’s drug drought?
  • 9:50 OVERVIEW OF BAYESIAN ANALYSES USED IN ADAPTIVE DESIGNS

    David Manner

    David Manner, Group Leader, Exploratory and Programme Medical Statistics, Eli Lilly

  • ¡Brief introduction of Bayesian methodology
  • Advantages of Bayesian analyses
  • Examples of Bayesian adaptive designs
  • Preparation for a Bayesian adaptive design
  • 10:30 Morning Coffee

    11:00 ADDRESSING IMPLEMENTATION CHALLENGES IN ADAPTIVE CLINICAL TRIALS

    Bill Byrom

    Bill Byrom, Senior Director of eClinical Strategy, Perceptive Informatics

  • How important is clean data in adaptive trial decision making?
  • Selecting the best approach to data collection and management
  • Randomisation adaptations – some example implementations and associated considerations
  • 11:40 ADAPTIVE DESIGNS AND PK/PD MODELLING IN LEARNING PHASE

    Bruno Boulanger

    Bruno Boulanger, Director, Exploratory Statistics, UCB

  • Adaptive Designs are usefull for identification and estimation of PK models
  • BAST: Bayesian Adaptive Sampling Times for PK models
  • Use of adaptive sampling times in constrained pediatric studies
  • Leveraging PK/PD models for optimizing adaptive designs
  • 12:20 Networking Lunch

    13:20 RANDOMIZING AND DRUG SUPPLY MANAGEMENT IN ADAPTIVE CLINICAL TRIALS

    Michael Borkowski

    Michael Borkowski, General Manager, United BioSource Corporation (UBC)

  • Three case studies on different ways to implement a Response Adaptive Randomization
  • What statisticians need to know about supply management in adaptive trials
  • Implementing the Dynamic Components of an Adaptive Trial
  • Considerations when Planning a Response Adaptive Trial
  • 14:00 IMPLEMENTING DOSE RANGING STUDIES

    Frank Miller

    Frank Miller, Principle Scientist, Biostatistics, AstraZeneca R&D

  • Clinical problem – unclear dose response relationship for a new potential drug
  • Using an innovative trial design to resolve this
  • Case study showing how a dose ranging design can be successfully implemented
  • Some results from the PhRMA Adaptive Dose Ranging working group
  • 14:40 SAMPLE SIZE REESTIMATION: A CASE STUDY IN MULTIPLE SCLEROSIS

    Tim Friede

    Tim Friede, Associate Professor of Medical Statistics, University Of Warwick

  • Regulatory issues
  • Reestimation procedure for MRI lesion count data
  • Implementing sample size reviews in MS
  • 15:20 Afternoon Tea

    15:50 STRATEGIES AND PRACTICAL CONSIDERATIONS FOR ORPHAN DRUG DEVELOPMENT WITH ADAPTIVE DESIGN

    David Zhang

    David Zhang, Associate Director, Clinical Biostatistics, Genentech

  • The unique challenge of developing therapeutic agents with unclear regulatory pathway and difficult recruitment
  • How adaptive designs can help with effective decision making to save resource and improve probability of success
  • Case study of how this works in practice
  • 16:30 ADAPTIVE DESIGN - A SHORTCUT TO PERSONALISED MEDICINE?

    Yu Shyr

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

    ·         Biomarker endpoint vs. surrogate endpoint vs. clinical endpoint

    ·         Prognostic biomarker vs. predictive biomarker

    ·         The recent development of biomarker-adaptive trial designs

    ·         Limitation of the biomarker-adaptive designs

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alun Bedding

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

    9:10 ADAPTIVE TRIAL DESIGN – REALISING THE POTENTIAL

    Richard Young

    Richard Young, Director Business Development, Cmed Clinical Research Services

  • The practical execution of ATD studies requires near real time data acquisition and 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.
  • A number of case studies will presented of how this has been achieved and the lessons learned.
  • 9:50 PLANNING FOR SUCCESS - BUT HOW DO I KNOW I HAVE A GOOD DESIGN?

    Judith Quinlan

    Judith Quinlan, Vice President, Adaptive Trials, Cytel

  • Case study
  • Thought and planning process that lead to selecting an adaptive trial design
  • Logistical and operational aspects
  • Randomization scheme option and drug supply realities
  • The benefits of investing in simulations at the upfront planning stage
  • 10:30 Morning Coffee

    11:00 CONSIDERING OPERATIONAL ASPECTS OF AN ADAPTIVE DESIGN STUDY

    Helen Eastham

    Helen Eastham, Study Delivery Programme Leader, AstraZeneca

  • Planning for all scenarios
  • Dose selection and managing dropped dose patients
  • Communications strategies
  • 11:40 IMPLEMENTING A BAYESIAN OUTCOME-ADAPTIVE RANDOMIZATION TRIAL (A CASE STUDY)

    Kye Gilder

    Kye Gilder, Senior Biostatistician, Biostatistics, Biogen Idec

  • Advantages and disadvantages of Bayesian outcome-adaptive randomization
  • Study design simulations
  • IVRS implementation and data collection/management complexities
  • Logistical issues and lessons learned
  • 12:20 Networking Lunch

    13:20 CUTTING EDGE TOOLS FOR SUPPORTING ADAPTIVE DESIGNS

    Tom Parke

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

  • Some core, generic adaptive designs are required to enter the mainstream
  • These will enable statisticians to learn cost benefits and 'how to' of adaptive designs
  • Such generic designs will enable trials to be run adaptively, with little additional design overhead
  • They could form a basis for further development of adaptive design 'archetypes'. 
  • Examples of generic designs for phase 2 adaptive dose finding studies
  • Software available to learn, understand and exploit them
  • Potential benefits
  • 14:00 SIMULATION IN ADAPTIVE TRIALS

    Alun Bedding

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

  • Modelling is a vital element of predicting and adapting to clinical outcomes
  • Simulating patient recruitment, and logistical
  • Real life case study of the application of innovative modelling
  • 14:40 DISEASE BIOSIMULATIONS FOR ADAPTIVE TRIALS

    Richard Ho

    Richard Ho, Senior Medical Director, Entelos

    15:20 Afternoon Tea

    15:50 CRITICAL APPRAISAL OF ADAPTIVE METHODS

    Christopher Jennison

    Christopher Jennison, Professor of Statistics, University Of Bath

  • Using simulation to assess overall performance
  • Application 1: Sample size modification
  • Application 2: Switching to a patient sub-population
  • Application 3: Treatment selection and testing in a combined Phase II/III design
  • 16:30 FASHION, FUTILITY AND FINANCE: ADAPTIVE DESIGNS IN A SMALL PHARMACEUTICAL COMPANY

    Tim Auton

    Tim Auton, Director of Scientific Operations and Project Management, Protherics, a BTG company

    17:10 Chairman’s Closing Remarks and Close of Conference

    +

    Workshops

    Bayesian Adaptive Dose Finding Studies
    Workshop

    Bayesian Adaptive Dose Finding Studies

    Crowne Plaza Hotel - St James
    3rd February to 4th February 2009
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

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