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Activity Number:
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155
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Type:
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Invited
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Date/Time:
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Monday, August 2, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306200 |
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Title:
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Doing Better Than Average: Tailored Therapeutics in Drug Development
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Author(s):
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Stephen J. Ruberg*+ and Stan Young*+ and Frank Rockhold*+ and Sue-Jane Wang*+ and Stephen Senn*+
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Companies:
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Eli Lilly and Company and National Institute for Statistical Science and GlaxoSmithKline and FDA and University of Glasgow
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285, 19 T.W. Alexander Drive, Research triangle park, NC, 27709-4006, USA , Philadelphia, PA, , 10903 New Hampshire Avenue, Silver Spring, MD, 20993, United States , Glasgow, International, ,
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Keywords:
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sub-group analysis ;
substantial evidence ;
tailored therapeutics ;
pharmacogenomics
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Abstract:
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Society is on the verge of advancing the practice of medicine to improve individual patient outcomes based on specific patient characteristics - whether they are genotypic or other biological markers or phenotypic information about the patient. To achieve this transformation in medicine, the statistics profession can be a key player in driving evidence-based medicine. In clinical drug development, there are many issues for design of clinical trials to "prove" the predictive ability of a particular patient characteristic, as well as issues related to exploratory analysis of patient sub-groups. Conversely, when safety is involved, under what circumstances should a safety signal be considered noteworthy versus spurious? This panel will be a Q&A session with a blend of pharmaceutical industry, regulatory and academic experts and leaders. There will also be time for audience participation.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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