Abstract Details
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Activity Number:
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468
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307883 |
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Title:
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How to Maximize the Usefulness of Predictive Biomarker Data in Development of Personalized Medicines
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Author(s):
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Cong Chen*+
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Companies:
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Merck and Company Inc
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Keywords:
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oncology ;
benefit-cost ratio ;
adaptive design
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Abstract:
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The future of oncology drug development lies in identifying subsets of patients who will benefit from particular therapies, using predictive biomarkers. These technologies offer hope of enhancing the value of cancer medicines, and reducing size, cost, and failure rates of clinical trials. However, examples of failure of predictive biomarkers also exist. In these cases biomarker use added cost, complexity, and time, and narrowed the treated population unnecessarily. Here we present methods to adaptively integrate predictive biomarkers into Phase 2 and Phase 3 clinical programs, in a data driven manner in which these biomarkers are emphasized in exact proportion to the evidence supporting their clinical predictive value. The resulting program demands value from predictive biomarkers and is designed to optimally harvest this value for oncology drug development.
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Authors who are presenting talks have a * after their name.
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