Co-development of pharmacogenomic biomarkers and assays in the context of drug development

Keywords Genomic biomarkers, pharmacogenetics, pharmacogenomics, assays, platforms, genetic testing, drug development, companion diagnostic (CDx), in vitro diagnostics (IVD), co-development, biomarkers, assay development, -omics
Description

This reflection paper provides guidance on the co-development of a new pharmacogenomic biomarkers and the relevant assay(s) in the context of either a drug development or for qualification purposes.

 

The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper.

 

The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.

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