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

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

Current effective version

Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development

Consultation dates: 24/06/2010 to 30/11/2010Draft: consultation closedReference Number: EMA/CHMP/641298/2008

First revision

Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle

Consultation dates: 28/07/2017 to 15/11/2017Draft: consultation closedReference Number: EMA/CHMP/800914/2016