Andrew Crenshaw | August 19, 2019

Companion Diagnostics with Andrew Crenshaw

I-O clinical development podcast series
Andrew Crenshaw is the Global CDx Discipline Director at Q2 Solutions. 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. 

This is the fifth episode in a podcast series on Immuno-oncology laboratory services.

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