The changing role of Biomarkers
November 2004
The field of Biomarker analysis is probably the most rapidly evolving area within clinical and bioanalytical laboratories providing analytical services in support of pharmaceutical development.
This new attention is driven by the changing role for the use of a biomarker from a diagnostic to a more efficacy measurement tool.
There are a number of issues related to this work that cause concern and need more attention.
Most of the diagnostic biomarkers are traditionally analyzed in a clinical environment in order to investigate whether the biomarker is present or the concentration found falls within the expected normal ranges. Methods are validated mostly according to the CLIA guidelines.
By using the biomarker as an efficacy parameter, in order to investigate the effects of a certain treatment, we are moving more into the bioanalytical field for pharmacokinetic (PK) analysis.
Regulators such as the FDA have given little or no critical guidance or regulatory requirements for biomarker validation and control of these tests. Nevertheless, it is auditing (and rejecting!) data submitted from these tests as Pharmacodynamic (PD) biomarkers. This auditing is normally done against the standards used for Pharmacokinetic (PK) analysis.
Within this application field methods are validated according to FDA Guidance for Industry 2001. Which means that it is required to demonstrate that a particular method is reliable for the intended application. This has a major impact on the procedures for the validation, analysis and reporting of the biomarkers.
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