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  • Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Abstract Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information,...
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    Considerations for Development and Implementation of a Companion Diagnostic

    This article discusses four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.   Introduction   The drug development process in the US is extremely long and costly. It is critical to get the patient a drug that is going to work for them. Especially in the oncology space, drugs for the most part are extremely toxic to the patient. Therefore, not only is th...