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April 2012
EARLY CLINICAL INSIGHTS:
The Case for Early Cardiac Safety Data & Modeling

Speakers for this Event:
  • Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac
        Safety Services
      Learn More
  • J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular
        Safety
      Learn More
  • Jared Schettler, MS, Director, Quintiles Phase I Biostatistics  Learn More
  • EARLY CLINICAL INSIGHTS: The Case for Early Cardiac Safety Data & Modeling

    This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design.

    With increasing research and development costs and declining pipeline success, pharmaceutical companies need to be more discerning in early development by maximizing the data and insights gleaned in Phase I/IIa studies. Through evolving techniques and methods, researchers are exploring new ways to obtain more robust data before proceeding to larger, late-stage trials.

    One such approach is through conducting more rigorous cardiac safety assessments in early Phase I trials. The cardiac safety regulatory landscape requires assessment of an investigational drug's proarrhythmic liability, currently operationalized as drug-induced QT/QTc interval prolongation. While rigorous QT/QTc measurements are taken in the Thorough QT/QTc (TQT) study, it is not typically conducted until relatively late in Phase II clinical development. However, more rigorous assessments in early Phase I trials can be very valuable in scenarios involving both "no-go" and "go" decisions. Reliable observation of an unacceptable degree of QT/QTc interval prolongation can enable an earlier, less costly "no-go" decision. Additionally, if a “go” decision is made, the initial data permits subsequent studies to be designed in the most resource-efficient manner while preserving full scientific integrity.

    A good initial understanding of the degree of drug-induced QT/QTc prolongation, and also the variability in such prolongation seen among subjects, enables the TQT to be designed with the minimum necessary number of subjects, leading to a less expensive and shorter study, hence a shorter overall clinical development program.

    THIS PROGRAM IS INTENDED FOR:

    EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:

    • Clinical R&D
    • Clinical Operations
    • Regulatory Affairs
    • Medical Affairs
    • Outsourcing Management
    ABOUT OUR SPEAKERS:

    Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac Safety Services

    Dhiraj Narula, MD, joined Quintiles Cardiac Safety Services in 2004 as Medical Director. A board certified cardiologist and electrophysiologist, he is a member of the Royal College of Physicians in the United Kingdom and a Fellow of the American College of Cardiology.

    Dr. Narula is trained in London, Mumbai, New York and Hartford, Connecticut, and continues to see patients at his practice in Las Vegas.

    Dr. Narula is widely published, with numerous articles in the New England Journal of Medicine, American Heart Journal, European Heart Journal, and Indian Heart Journal, as well as contributing to medical textbooks. He has received more than a dozen professional honors, including prizes, scholarships, a fellowship and a teaching award.

    J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular Safety

    J. Rick Turner, PhD, is an experimental research scientist and clinical trialist, Editor-in-Chief of the Drug Information Journal, a Senior Fellow at the Center for Medicine in the Public Interest, and a Fellow of the Society for Behavioral Medicine. He is an author of more than 100 peer-reviewed papers and articles in professional journals, and an author of nine books.

    Prior joining Quintiles, Dr. Turner was Chairman of the Department of Clinical Research at Campbell University School of Pharmacy, a Clinical Submissions Scientist at GlaxoSmithKline, and President and Chief Scientific Officer at Turner Medical Communications LLC. Previously, he conducted research in the field of Cardiovascular Behavioral Medicine at three US academic medical centers.

    Dr. Turner received two international research awards (from the American Psychosomatic Society and the Society for Psychophysiological Research) for his ground-breaking research in the field of cardiovascular reactivity, and published the first student textbook on this topic.

    Jared Schettler, MS, Director, Quintiles Phase I Biostatistics

    Jared Schettler has been with Quintiles for eight years and currently leads Phase I Biostatistics. He supports daily Phase I operations, the Quintiles Cardiac Safety Services group and the Population PK Modeling group.

    Mr. Schettler has previously supported research for the Stanford School of Medicine and in the fields of aerospace, e-commerce, medical econometrics, and microarray analysis. He studied mathematics at Grinnell College and with Eötvös University in Budapest, earned a M.S. in Applied Statistics from Oregon State University, and also taught mathematics in Malawi, Africa. Mr. Schettler has supported over 200 clinical trials of all phases, including over 20 TQT trials. His professional expertise and interest lie in linear and nonlinear mixed models for PK/PD.

    OUR XTALKS PARTNER FOR THIS EVENT:

    Quintiles helps you navigate the complexities of early-phase trials with scientific expertise, innovative approaches and flexible solutions to ensure smarter, faster trials. So you get the insights you need to confirm compound viability, identify risks and make go/no-go decisions with speed and confidence. Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com/clinical-services/phase-i-iia/.

    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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