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

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.

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

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