Process Map Proposal for the Validation of Genomic Biomarkers

Abstract

How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process.

Keywords: :

• biomarker
• clinical
• genomic
• preclinical
• validation

Disclaimer

The opinions expressed in this publication are those of the authors and not necessarily those of the US FDA.