Biomarker Development from Discovery through Companion Diagnostic Commercialization

Increasingly, biomarkers play a key role in therapeutic development programs and have been shown to improve drug approval success rates by nearly 3-fold. Some biomarkers transition to become a companion diagnostic and as such, are a required test for prescribing a specific therapy. In this webinar, we focus on the development journey of a biomarker from early discovery, through clinical development and ultimately to an approved, commercially available companion diagnostic test. We present the example of and best practices discerned from a recently approved companion diagnostic assay which is used to assess the eligibility of patients with urothelial cancer for treatment with the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib).

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