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November 18, 2009
Real-time Clinical Trial Decision Making

Keynote Speaker for this event:
  • Judith Quinlan,  Vice President, Adaptive Trials, Cytel Inc.  Learn More

  • Reaching the correct decisions - at the earliest time point - in the most efficient way

    With an unprecedented scope of options now possible with new adaptive trials, how can clinical study sponsors determine their best approach?

    Join noted Judith Quinlan, Cytel’s Vice President of Adaptive Trials, for an in-depth look at the most effective strategies for planning and implementing this new breed of trials. 
     
    Judith’s adaptive trial expertise and clinical experience has helped some the most successful biopharmaceutical companies pursue a winning clinical research strategy.
     
    Actual early and confirmatory study case studies exemplify best practices proven to overcome any barriers and take full advantage of today’s era of adaptive development.
     
    Trial planning: how do you know we have a good design?

    • Asking the right development questions - how to avoid racing toward the wrong answer
    • Why trial simulations? – assessing options and determining best design
    • Working with colleagues – preparing internally for success
    • Working with regulators
    • Beyond the current trial - the impact on subsequent studies

    Implementation: are you fully prepared for the consequences of adaptive changes?

    • Simulation use in the execution phase, including supply forecasts and cost analysis
    • Forecasting investigation site accrual rates
    • Implementing the recommended changes following interim analysis
    THIS PROGRAM IS INTENDED FOR:

    VPs, Directors, Heads, and Managers of the following areas:

    • Quantitative Clinical Pharmacology
    • Strategic Modeling and Simulation
    • Statistical Science
    • Biostatistics
    • Pharmacology Modeling and Simulation

    as well as:

    • Therapeutic heads
    • Biopharmaceutical and device company leadership (development and clinical, not discovery/lab)
    • Clinical staff, investigators
    • Regulatory and medical affairs
    • Regulators
    • Drug/biologic supply managers
    ABOUT OUR SPEAKERS:

    Judith Quinlan,  Vice President, Adaptive Trials, Cytel Inc. 

    Judith Quinlan began her career as an agricultural statistician in Australia before joining GlaxoSmithKline. While at GSK, Judith was director of Statistics for Neurology and GI in the UK, later moving to the US as Director of Statistics for Biopharmaceuticals. Throughout her GSK tenure, Judith actively promoted the use of adaptive designs, and other new statistical approaches, to improve clinical development. Following 10 years with GSK, Judith joined Cytel as Vice President, Adaptive Clinical Trials.

    Judith now heads Cytel’s adaptive study consultancy business, responding to the rapidly increasing demand for better clinical approaches from pharmaceutical, biotechnology and medical device companies.

    An active member of the PhRMA Adaptive Design Working Group (ADWG), Judith chairs the Adaptive Trial Case Study work stream. Judith is an often invited speaker, well regarded by statisticians, biopharmaceutical management and regulatory officials for her innovative trial planning and implementation insights.

    Judith Quilnlan attended Flinders University (South Australia) and Murdoch University (Western Australia) and has a MSc (UK equivalent).

    ABOUT OUR SPONSORING PARTNER:

    Cytel Inc. is the leading provider of clinical trial design services and specialized statistical applications for the biopharmaceutical, medical device, academic and government research markets. 47 out of the top 50 biopharmaceutical companies and international regulator agencies use Cytel software to design trials and analyze study data. For over 20 years, Cytel has been providing trial sponsors with innovative tools and consultative services to increase clinical efficiencies and reduce development costs.

     

    ABOUT OUR MEDIA PARTNER:


    "http://www.pharmcast.com/ is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals.  http://www.pharmcast.com/ brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors.  It was created and is maintained by pharmaceutical and biotechnology professionals.  Visit http://www.pharmcast.com/ and discover for yourself why it is so popular among professionals."

     

    European Pharmaceutical Manufacturer (EPM) magazine, published by Rapid News Communications Group, is the pharmaceutical supply chain for ingredients, equipment, contract services and more. Now in its ninth year of publication, it is the only tabloid-style publication in the field of pharmaceutical manufacture in Europe. For fresh, up-to-date news, visit the EPM website, http://www.pharm-europe.com/.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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