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Session Information
2007 BIO International Convention
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Adaptive Designs in Learn & Confirm — Three Case Studies
Track : Drug Discovery and Development
Program Code: DDD060
Date: Tuesday, May 8, 2007
Time: 11:00 AM to 12:30 PM  
Location: 259 AB
CHAIR :
 Michael Krams, MD, Assistant Vice President, Adaptive Trials, Clinical Development, Wyeth Research, PA, United States
SPEAKER (S):
DR Brenda Gaydos, Research Advisor, Eli Lilly and Company IN, United States
Dr. Nitin Patel, Chief Technology Office, Co Founder, Cytel Software Corporation
Description
Three case studies will demonstrate how adaptive designs 1) may be enablers for biomarker development and vice versa; 2) could blur the lines between traditional drug development phases; and 3) may shift drug developers from a tactical to a more strategic approach. The presentations will address opportunities, but also outline statistical, operational and regulatory challenges.



Objectives:
  • Provide concrete examples on how to translate the concept into real studies.

  • Highlight the importance of long-term planning.

  • Share learning on how to facilitate implementation.

    • Streaming Audio with
    PowerPoint Slides
    (Code: DDD060)
      
    This session is a part of:
    Drug Discovery and Development 2-DAY TRACK
    Complete Set of BIO Online / CD-ROM - All 23 Tracks.