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SMi are pleased to announce their inaugural conference ‘Innovating Clinical Drug Development - A Focus on Biostatistics in Clinical Trial Design'. This event will bring together key statisticians from major pharmaceutical companies as well as academic opinion leaders in biometrics and representatives from regulatory agencies to discuss the merits of real time learning paradigms and current innovation in clinical drug development. Key issues include discussion on strategies to develop seamless R&D, exploration into efficient clinical trial design, featuring presentations from phase I-IV and case study evaluations of the best Bayesian, Non-parametric frequentist and sequential approaches to clinical trial design. Further consideration will be given to the regulatory perspective, implementation of real time learning and the role of modelling and simulation in drug development together with an assessment of hurdles, risks and how to overcome them. A must attend event for all those involved in clinical trials design and drug development

Speakers confirmed for the 2006 Event include:

  • Dr Michael Krams, Senior Director, CNS Clinical, Pfizer
  • Dr Vlad Dragalin, Senior Director, Research Statistics, GlaxoSmithKline
  • Prof Andy Grieve, Senior Director, Statistical Research & Consulting Centre, Pfizer
  • Dr Simon Day, Statistics Unit Manager, Medicines & Healthcare products Regulatory Agency (MHRA)
  • Dr Ivan Chan, Director, Clinical Biostatistics, Merck Research Laboratories
  • Dr Kit Roes, Head, Clinical Information & Director, Biometrics, Organon
  • Dr Mark Chang, Associate Director, Biostatistics, Millennium Pharmaceuticals
  • Dr Alun Bedding, Senior Research Scientist, Statistics & Information Sciences, Eli Lilly
  • Dr Qing Liu, Research Fellow, Johnson & Johnson
  • Dr Jerald Schindler, President, Cytel Pharmaceutical Research

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michael Krams

Michael Krams, Senior Director, CNS Clinical, Pfizer Global

9:10 IMPLEMENTING INNOVATION – THE PAST IS THE FUTURE

Jerald Schindler

Jerald Schindler, President, Cytel Software Corporation

  • The crisis in drug development
  • What is the decision problem?
  • What is our current approach to finding the answer?
  • Phase I, II, III, IV: Disjoint experimentation
  • The preclinical/clinical gap
  • Optimising drug development across the portfolio
  • Updating the development infrastructure
  • The role of statistics and the statistician in accelerating drug development
  • 9:50 UTILISATION OF BIOMARKERS IN DRUG DEVELOPMENT

    Mark Chang

    Mark Chang, Associate Director, Millennium Pharmaceutical

  • New challenges in drug development
  • Characteristics of biomarkers
  • Biomarker validation
  • Adaptive design using biomarkers
  • Software implementation
  • Practical issues
  • 10:30 Morning Coffee

    11:00 INNOVATIVE STATISTICAL METHODS FOR MULTIPLE ENDPOINTS

    Ivan Chan

    Ivan Chan, Director, Clinical Biostatistics, Merck Research Labs

  • Multiple endpoints and the implications for clinical trial designs
  • Regulatory challenges with multiple endpoints
  • Novel approaches to handling multiple endpoints via the use of composite endpoints, resulting in increased sensitivity (power) of detecting treatment effect
  • Innovative gate-keeping strategies to control false positive rates for hierarchical families of endpoints
  • A recent example with a large-scale phase III vaccine efficacy trial
  • 11:40 BIOSTATISTICS TO BRIDGE RESEARCH AND DEVELOPMENT

  • Translational science as a two way process
  • The multiple faces of Proof of concept
  • Implemented and new methodology - to go from discovery to full development and a useful new drug
  • Statistics and information technology to learn: feedback to research
  • Egbert Biesheuvel

    Egbert Biesheuvel, Associate Director, Biometrics, Organon International Bv

    12:20 Networking Lunch

    13:50 EFFICIENT PHASE I DESIGNS

    Inna  Perevozskaya

    Inna Perevozskaya, Clinical Biostatistics, Merck Research Laboratories

  • Decision problems in phase I
  • Non-viability
  • Continuous reassessment methods for efficient learning about MTD
  • Building a ‘therapeutic index’ in first in human study
  • Clinical discovery: systematical search for ‘serendipitous’ observations
  • Shifting from discrete experimentation to seamless process
  • 14:30 EFFICIENT PHASE II DESIGNS

    Andy Grieve

    Andy Grieve, Senior Director, Statistical Research & Consulting Centre, Pfizer

  • Decision problems in phase II – viability?
  • Safety in patients - determining the common short-term side effects and risks associated with the drug
  • Proof-of-concept
  • Learning about exposure-response
  • Choosing the correct dose for phase III
  • Real time learning paradigms
  • Adaptive designs
  • Dynamic termination rules
  • Seamless process?
  • 15:10 Afternoon Tea

    15:40 EFFECTIVE LATE STAGE CLINICAL DEVELOPMENT

    Qing Liu

    Qing Liu, Research Fellow, Johnson & Johnson

  • Challenge to adaptive designs: fast enrolment and long follow-up
  • Ensuring validity without specifying the adaptation rules
  • Frequentist approach for worldwide regulatory applications
  • Dose-response information to support drug registration
  • Dropping the losers and sample size adjustment
  • Trend tests and modelling the dose-response
  • Examples
  • 16:20 ADAPTATIONS IN LATE STAGE CLINICAL TRIALS

    Tim Friede

    Tim Friede, Biostatistics & Statistical Reporting, Methodology Group, Novartis Pharma

  • The internal pilot study design in clinical trials
  • Regulatory requirements on sample size re-estimation
  • Blinded vs unblinded procedures
  • Differences between superiority and non-inferiority trials
  • Decision tools supporting interim adaptations
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Andy Grieve

    Andy Grieve, Senior Director, Statistical Research & Consulting Centre, Pfizer

    9:10 A REGULATORY PERSPECTIVE

    Simon Day

    Simon Day, Statistics Unit Manager, Medicines & Healthcare products Regulatory Agency (MHRA)

  • Can adaptive designs contribute as supportive or confirmatory evidence?
  • ‘Single Pivotal Trial’ covers a multitude of sins
  • Regulatory implications in the implementation of flexible and adaptive designs
  • How to facilitate interactions with regulatory agencies in designing and implementing innovative clinical trial designs
  • 9:50 BAYESIAN APPROACHES

    Robert Lew

    Robert Lew, Biostatistician & Professor, Boston University

  • Recent examples of where Bayesian approaches have been practically applied
  • How to get it right?
  • When is it the preferred option?
  • Detecting and monitoring safety signals
  • The use of Bayesian approaches in the pharmaceutical industry
  • Future uses to support all aspects of clinical drug development
  • 10:30 Morning Coffee

    11:00 HANDLING PARTIALLY MISSING INFORMATION

    Philip  Hougaard

    Philip Hougaard, Senior Specialist, Biostatistics, H Lundbeck A/S

  • Compliance
  • Reasons for dropout
  • Right-censored survival data
  • Interval-censored survival data
  • Intention to treat
  • Last observation carried forward
  • Observed cases
  • Repeated measurements modelling
  • 11:40 IMPLEMENTING ADAPTIVE DESIGNS FOR DRUG DEVELOPMENT

    Vlad Dragalin

    Vlad Dragalin, Senior Director, Research Statistics, GlaxoSmithKline

  • The classification of adaptive designs
  • Four main elements of adaptive design – allocation rule, sampling rule, stopping rule and decision rule
  • Why choose an adaptive design?
  • Achieving the goals
  • Adaptive designs in early phase clinical trials – implementation
  • Case studies to exemplify capabilities/ limitations
  • Future prospects – could this be the new product development tool?
  • 12:20 Networking Lunch

    13:50 IMPLEMENTATION

    Michael Krams

    Michael Krams, Senior Director, CNS Clinical, Pfizer Global

  • The data
  • The designs
  • The approach: Bayes and decision-theory
  • How to make it happen
  • Case studies
  • 14:30 THE ROLE OF MODELLING AND SIMULATION

    Carl-Fredrik Burman

    Carl-Fredrik Burman, Senior Statistical Scientist, AstraZeneca

  • Simulation guided clinical trial designs
  • Extracting information from data
  • Assessing the contribution made to drug development
  • Deciphering the optimal trial design for future clinical testing
  • In silico drug development
  • Why real clinical trials will never be redundant
  • 15:10 Afternoon Tea

    15:40 CUSTOMISED SOFTWARE INCORPORATING ADAPTIVE RANDOMISATIONS FOR CLINICAL TRIALS

    Eva Miller

    Eva Miller, Manager Biostatistics, Interactive Clinical Technologies Incorporated

  • Achieving balance in adaptive randomisations
  • Theoretical framework for adaptive algorithms
  • Determining the random adaptive algorithm
  • Developing random adaptive modules in clinical trial systems
  • Status of use and regulatory acceptance of adaptive randomisations
  • 16:20 IMPLEMENTATION OF REAL TIME LEARNING FOR THE ASTIN TRIAL (AND OTHERS)

    Tom Parke

    Tom Parke, Project Manager, Tessella Support Services Plc

  • Simulating the trial, optimising the trial parameters
  • Getting sufficient live data, sufficiently quickly
  • Trial management
  • Analysis tools
  • Supporting the independent data monitoring committee
  • Implement for one trial or for many?
  • The serendipitous benefits of running adaptive trials
  • 17:00 Chairman’s Closing Remarks Followed by Afternoon Tea

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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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