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Clinical trials run by pharmaceutical and biotech companies have undergone major changes, implementing adaptive designs to tailor a trial. Reduction in costs and timings of early phase clinical trials can mean lower recruitment of patients and improve the overall clinical accuracy. Successful implementation of adaptive designs into a trial however requires unparalleled coordination between clinicians, trial managers, statisticians and those involved in external and internal regulation.

Our expert speakers are widely regarded as industry leaders - hear through case studies how all sizes of pharma companies have successfully implemented trials incorporating adaptive designs. This conference - the only in Europe to focus specifically on adaptive designs- will provide you with new intelligence on internal and external regulatory expectations and new data on evaluating adaptive dose ranging studies.

Adaptive Designs in Clinical Trials 2013 aims to show you how you can quickly and accurately implement an adaptive design clinical trial for your drug development - from initial processes in managing trials to choosing the right time to implement change. 

  • Its the only conference in Europe to focus specifically on adaptive designs
  • Benefit from the first-hand experiences of speakers whose organisations have recently made breakthroughs in adaptive designs
  • Hear the very latest on predicative analytical techniques for increasing efficiency of drug development
  • Learn how to develop a normal standing clinical trial in an adaptive trial
  • Discover data software that supports the ever-increasing complexity of adaptive clinical trials by attending the post-conference workshop

You should attend this event if you are a Director, Chief Executive, Chief Scientific Officer, Vice President, Head of Department, Principal Scientist or Statistician within the Pharmaceutical or Healthcare industry with responsibilities in the following areas:
• Biostatistics
• Adaptive Trials Design
• Regulatory Affairs
• Clinical Drug Development
• Contract Research
• Clinical Operations
• Research and Development
• Intellectual Property
• Legislation & Policy Advice
• Drug and Safety Assessment
• Clinical Pharmacology
• Experimental Medicine
• Clinical Trials
• Business Development
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Vladimir Anisimov

Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles

9:10 The motivation, promise, and success of bayesian adaptive trial design

Roger Lewis

Roger Lewis, Senior Medical Scientist , Berry Consultants

  • A well designed adaptive trial can mitigate the risk of having a failed clinical trial
  • Systematically and rigorously addressing key uncertainties that exist during the design of a confirmatory trial
  • Avoiding “anticipated regret” and avoiding undue focus on minor threats to trial success
  • When a trial is adaptive “by design,” all relevant statistical threats to trial validity can be rigorously addressed via simulation
  • The productive use of adaptive designs is limited mostly by the conservative nature of those designing trials and by a paucity of statisticians familiar with adaptive design and simulations methods, rather than by substantive theoretical or regulatory concerns.
  • 9:50 Incorporating Adaptive Trial Design Approaches in Oncology Clinical Trials

    Traditional oncology trials are inefficient, expensive, and suffer from high failure rates
    Adaptive design approaches can be incorporated in all phases of oncology research, including:


    More accurate determination of maximum tolerated dose in Phase I
    Better understanding of dose response and target population in Phase II
    Overcoming high failure rates of phase III trials
    A major opportunity for mitigating risk in oncology drug development is improvement in Phase II strategies to reduce risk of late Phase III failure and to improve the chance of overall success

    Jurgen Hummel

    Jurgen Hummel, Associate Statistical Science Director, PPD

    Roger Lewis

    Roger Lewis, Senior Medical Scientist , Berry Consultants

    10:30 Morning Coffee

    11:00 An adaptive design to explore prevention therapies for Alzheimer Disease

    Michael Krams

    Michael Krams, VP - Head of Neurology Franchise, Johnson & Johnson

  • The research question – Alzheimer’s Disease
  • Applying adaptive design methodology to the research question
  • Biomarkers as enablers for the adaptive design
  • Case Study
  • 11:40 Bayesian Adaptive Designs for Oncology Phase I Trials

    Alessandro Matano

    Alessandro Matano, Senior Statistician, Novartis Pharmaceuticals

  • Oncology Ph I: Challenges & Design Requirements
  • Design Overview
  • Implementing a Bayesian Design
  • Case Study
  • 12:20 Networking Lunch

    13:40 Designing multi-arm multi-stage clinical trials

    Thomas Jaki

    Thomas Jaki, Researcher, Department of Mathematics and Statistics, Lancaster University

  • Two principle approaches for designing multi-arm multi-stage clinical trials
  • Discussion: Options for selecting treatments
  • Software to design such studies is presented
  • 14:20 Predictive analytical techniques for increasing efficiency of drug development

    Vladimir Anisimov

    Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles

  • Main uncertainties and interactions between adaptive trial design, patient recruitment,  randomization
  • Adaptive patient recruitment prediction and trial cost modelling
  • Data-driven predicting trial performance and site productivity
  • Predictive event modelling and adaptive recruitment adjustment
  • Optimization of different stages of drug development
  • 15:00 Afternoon Tea

    15:30 From preclinical studies to adaptive designs - A path to the future

    Emmanuel Pham

    Emmanuel Pham, Sr Director, Global R&D Statistics, Ipsen

  • Preclinical data is very often underused, whereas they can provide very valuble prior information for Bayesian approach
  • Adaptive design can also be implemented in non-clinical studies to maximise the information extracted from the study
  • This extenses approachs opens the way to a global approach of drug development; fully data driven and allowing early selection of a  winning area for a project.
  • 16:10 Pediatric adaptation: early (stage) we practice, later perhaps we practice less

    Andy Kenwright

    Andy Kenwright, Project Statistician , Roche Products Limited

  • Examples of adaptive designs in early stage pediatric trials are documented and hopefully growing
  • However for late stage confirmatory trials (to gain regulatory approval and license) examples seem fewer and further between efficient trial designs should give the same benefits to patients and clinical development programs, regardless of patient age.
  • By discussion of the potential barriers and challenges within pediatric studies, with the help of recent case studies, perhaps we can improve pediatric trial designs.
  • 16:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Andy Grieve

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

    9:10 Controlling the weighted sum of type I and type II errors and implications for the design and analysis of adaptive designs

    Andy Grieve

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

  • Hypothesis Testing in Clinical Trials
  • Should Type I Error be Fixed in Drug Development?
  • An Alternative to Maximising Power for Fixed type I Error
  • Traditional values for Type I and Type II Error Rates and Implications for the Relative Costs of These Errors
  • An Alternative Form of the Neyman-Pearson Fundamental Lemma
  • The Likelihood Principle and Adaptive Trials
  • 9:50 Adaptive Population Enrichment for Oncology Trials with Time to Event Endpoints

    Pantelis Vlachos

    Pantelis Vlachos , Principal Biostatistician, Cytel Corporation

  • Motivation for enrichment trials in oncology
  • Adaptive enrichment design for PFS endpoints
  • Simulation tools to evaluate power under different scenarios
  • Future directions
  • 10:30 Morning Coffee

    11:00 On the p-value in adaptive designs; Understanding the adaptive p-value

    Frank Fleischer

    Frank Fleischer, Teamleader Clinical Biostatistics, Boehringer-Ingelheim

  • Understanding the adaptive p-value
  • Comparing fixed vs adaptive p-values-when is an adaptive p-value "better"
  • A case study for the promising zone in asthma
  • 11:40 Bayesian model-guided first in human dose escalation trials in healthy volunteers

    Jouni Kerman

    Jouni Kerman, Statistical Methodologist, Novartis

  • Use a predictive model to provide supporting information for dose-escalation decisions for a data monitoring committee
  • Design the model to provide high-quality predictions; the model must be fully trusted by the clinical team and hence based on prior information dwarn form expert opinion and on prior research
  • Case study illustrating design of such a model and use in practice
  • 12:20 Networking Lunch

    13:30 Decision support for design of clinical trial programmes

    Martin Siman

    Martin Siman , Director, Design and Interpretation Centre of Excellence, AstraZeneca

  • Designing a clinical development programme includes a string of decisions. The design problem is multi-staged, iterative and collaborative, with extensive communication among teams of experts in various disciplines, and with a problem statement that often is ill-defined to start with and gradually becomes clearer.
  • A framework and tool were developed and implemented for transparently translating target product claims into study specifications so that scientific questions as well as underlying assumptions and risks are clearly defined.
  • Case study.
  • 14:10 Adaptive sample size and modification in clinical trials: Start small then ask for more?

    Chris Jennison

    Chris Jennison, Professor of Statistics, University Of Bath

  • Methods for adaptive sample size re-estimation at interim analyses
  • Understanding Mehta and Poock's "indifference zone" approach
  • Improving Mehta and Pocock's approach to make better use of additional sample size
  • Use of group sequential stopping rules with a delayed response
  • 14:50 Afternoon Tea

    15:20 From the idea to the publication in academic trials

    Genevieve Depresseux

    Genevieve Depresseux, Academic research manager, Université Catholique de Louvain (Bruxelles)

  • Protocol development
  • Quality of data and monitoring
  • Governing the logistics
  • Chronology of the steps and critical points
  • 16:00 Bayesian Variable selection (BVS) approach for dose-response modelling

    Adetayo Kasim

    Adetayo Kasim, Research Statistician, Durham University

  • Introduction of BVS
  • Application to dose-response modelling
  • Comparison with other methods
  • Case study
  • Review and discussion
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andy Grieve

    Andy Grieve

    Senior Vice President Clinical Trial Methodology, Aptiv Solutions
    Andy Kenwright

    Andy Kenwright

    Project Statistician , Roche Products Limited
    Emmanuel Pham

    Emmanuel Pham

    Sr Director, Global R&D Statistics, Ipsen
    Vladimir Anisimov

    Vladimir Anisimov

    Senior Strategic Biostatistics Director, Quintiles

    Adetayo Kasim

    Research Statistician, Durham University
    Adetayo Kasim

    Alessandro Matano

    Senior Statistician, Novartis Pharmaceuticals
    Alessandro Matano

    Andy Grieve

    Senior Vice President Clinical Trial Methodology, Aptiv Solutions
    Andy Grieve

    Andy Kenwright

    Project Statistician , Roche Products Limited
    Andy Kenwright

    Chris Jennison

    Professor of Statistics, University Of Bath
    Chris Jennison

    Emmanuel Pham

    Sr Director, Global R&D Statistics, Ipsen
    Emmanuel Pham

    Frank Fleischer

    Teamleader Clinical Biostatistics, Boehringer-Ingelheim
    Frank Fleischer

    Genevieve Depresseux

    Academic research manager, Université Catholique de Louvain (Bruxelles)
    Genevieve Depresseux

    Jouni Kerman

    Statistical Methodologist, Novartis
    Jouni Kerman

    Jurgen Hummel

    Associate Statistical Science Director, PPD
    Jurgen Hummel

    Martin Siman

    Director, Design and Interpretation Centre of Excellence, AstraZeneca
    Martin Siman

    Michael Krams

    VP - Head of Neurology Franchise, Johnson & Johnson
    Michael Krams

    Pantelis Vlachos

    Principal Biostatistician, Cytel Corporation
    Pantelis Vlachos

    Roger Lewis

    Senior Medical Scientist , Berry Consultants
    Roger Lewis

    Thomas Jaki

    Researcher, Department of Mathematics and Statistics, Lancaster University
    Thomas Jaki

    Vladimir Anisimov

    Senior Strategic Biostatistics Director, Quintiles
    Vladimir Anisimov

    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.

     

    HOTEL BOOKING FORM

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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:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    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.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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