Saturday, May 5, 2012

The Challenges to Implementing Innovation in Drug Development – What can be Done?


  • Last month, DIA teamed up with the FDA and Hearth Rhythm Society to present a meeting on Cardiovascular Safety and State-of-the-Art Development Issues: Type 2 Diabetes Mellitus Medications, QT, Benefit/Risk Assessment, Arrhythmias, Thrombosis, and Cardiotoxicity (Apr 17 2012 8:00AM - Apr 18 2012 5:00PM at the Washington Marriott Hotel)  
    Designed to improve pharmaceutical and medical product development by analyzing and mitigating potential risks, participants had the opportunity to:
    • Learn how to optimize cardiovascular (CV) safety assessments in the hopes of developing more effective medications to treat type 2 diabetes mellitus and other diseases
    • Attend plenary sessions and select from two tracks on diabetes and CV safety
    • Participate in debate-style presentations
    • Interact with FDA and other regulatory officials
    • Attend scientific abstract presentations
    • Engage in robust networking opportunities

    Several of the presentations are available on the FDA website.  
    CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-counter products. Materials and overviews from some of those meetings are listed in the presentations library.
    The Challenges to Implementing Innovation in Drug Development – What can be Done? Douglas C. Throckmorton, MD
    Deputy Director, Regulatory Programs, Office of the Center Director, CDER
    FDA, United States 



  • Integrating Patient Preferences into Benefit-Risk Analysis
    Robert J. Temple, MD
    Deputy Center Director for Clinical Science, CDER
    FDA, United States




    Balance on CV SafetyDo We Have It Right?
    Robert J. Temple, MD
    Deputy Center Director for Clinical Science, CDER
    FDA, United States



    For the full listing of CDER FDA presentations, please visit this link
    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm074833.htm


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