Abstract Details
Activity Number:
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163
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 5, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #309618 |
Title:
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Challenges in Oncology Drug-Diagnostics Co-Development
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Author(s):
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Ru-Fang Yeh*+
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Companies:
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Genentech, Inc.
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Keywords:
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drug development ;
companion diagnostic
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Abstract:
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Drug development has become prohibitively expensive due to the high attrition rate historically. It has been increasingly important to incorporate diagnostics in the drug development process to improve response to treatment and increase overall success rate. In this talk, I'll discuss issues arising during the concurrent development of drug and companion diagnostics that aim to demonstrate efficacy of a new therapy and validity of a predictive biomarker at the same time. Examples in oncology will be used to highlight challenges in the design, implementation and decision-making of such trials.
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Authors who are presenting talks have a * after their name.
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