The development of Companion Diagnostics to support a therapeutics clinical development and approval requires coordination between Pharma, IVD, CRO and Global Central Lab industries. Different technologies will be discussed and the various validation and verification activities within the Global Central Lab will demonstrate the process and the complexities in order to achieve simultaneous approval of therapeutic and companion assay.
Learning Objectives:
Upon completion, participant will be able to understand what a Companion Diagnostic is and how they differ from other biomarker assays.
Upon completion, participant will be able to appreciate the complex nature of Companion Diagnostic Development and understand the technologies associated with these type of assays
Upon completion, participant will be able to understand the steps (Regulatory, Science, Clinical) involved in Companion Dagnostic development
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