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European Medicines Agency Publishes Concept Paper on Biomarker Best Practices

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Last month the EMA published a “concept paper” to organize the drafting of a “Guideline on good genomics biomarker practices,” and to provide a way for interested parties to provide ideas and feedback on the proposal.

The proposed guidelines are being drafted to address a key problem in translational science, that being the ability to run clinical trials using the best information possible about suitable biomarkers.

The paper states: “The progress of technologies generates new knowledge in potential association of genomic biomarkers of health and disease at an unprecedented speed in science: however translation of this information into clinical tools currently lags behind.”

This is very much the problem that we are seeking to address with a comprehensive knowledge base like BiomarkerBase. The more we are able to include biomarkers in the database that have been well-validated, the more opportunity we provide to our users to identify the most effective biomarkers for their clinical trials and test products.