In this episode, he describes strategies for mitigating risk in the development of companion diagnostics (CDx) for immuno-oncology. CDx increase the chance of identifying the correct population of patients that will benefit from a specific therapeutic, and CDx development includes providing different strategies to reduce risks in drug development. A companion diagnostic is defined as a medical device, such as an in vitro device or an assay, that provides essential information regarding the safe and effective use of a corresponding drug, or of a therapeutic product. One challenge drug developers face is in developing an assay that correctly characterizes a biomarker. Additionally, there could be challenges in entering certain markets due to the accessibility of technologies used to identify biomarkers, or limitations in testing biomarkers globally. Andrew discusses an alternative to a traditional three-way partnership of a drug developer, an IVD manufacturer and a CRO, ways to reduce upfront investment needed for an IVD, and how to achieve better alignment for the management of the project timeline.
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