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Drug/Diagnostic Co-Development: When to Begin the Tandem Ride

Executive Summary

Targeted drug development raises a new conflict of interest possibility when a company hoping to market a drug is also trying to win approval for the diagnostic that proves the drug's efficacy. That problem of "self-validation" is one aspect of the even broader drug/diagnostic question: when and how a company should go about validating a biomarker it wants to incorporate onto a drug label.
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