Companion Diagnostics 2017

Development of effective and approved companion diagnostics (CDx) begins with a robust assay to indicate response to a therapy for a druggable target. In addition, an assessment is made of the market value of a CDx strategy of identifying responders vs offering a therapy to a general population.

Assays developed for immuno-oncology related pathways have provided an example of the potential for companion diagnostics to identify responders and grow the market.

In this session we review model systems (e.g., PD-1/PD-L1) and consider other examples of emerging technologies that may lead to similar CDx solutions and follow-on Precision Medicine efforts.

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Emerging CDx technologies promise fresh insights, balanced with comprehensive and real-time data analytics to target safe and efficacious treatments of patients. In this Symposium we address clinical trial design, implementation, data collection, logistics, and the partnerships that make progress possible.

Lessons learned will include regulatory issues, collaboration management, as well as protocols for handling exceptions and corrective actions.