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Activity Number:
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329
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Type:
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Roundtables
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Date/Time:
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Tuesday, August 4, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304402 |
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Title:
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Establishing Biomarkers That Are Predictive of Efficacy in Retrospective Analyses
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Author(s):
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Terry Katz*+ and Michael Szarek
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Companies:
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ImClone Systems and ImClone Systems
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Address:
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33 ImClone Drive, Branchburg, NJ, 08876,
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Keywords:
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Biomarker ; FDA ; ODAC ; Retrospective ; Missing Data
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Abstract:
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At a recent Oncologic Drugs Advisory Committee (ODAC) meeting, the Food and Drug Administration (FDA) asked the panel to discuss the circumstances where retrospective analyses of biomarker data could be supportive of labeling changes. This roundtable will review the data presented at ODAC, the FDA's feedback and the panel's deliberations, and explore the statistical challenges in establishing the predictive value of biomarkers when considering different efficacy endpoints, diverse treatment regimens and lines of treatment, and varying levels of missing biomarker status across studies.
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