The European Medicines Agency pays close attention to research into the use of biomarkers in the development of medicines.
Biomarkers are tests that can be used to follow body processes and diseases in humans and animals. They can be used to predict how a patient will respond to a medicine or whether they have, or are likely to develop, a certain disease. For example, the levels of chemicals in the fluid surrounding the brain may be able to predict the likelihood that a patient with mild memory problems will go on to develop dementia due to Alzheimer's disease.
Biomarkers are playing an increasingly important role in the development of new medicines. The Agency expects that their use in research will contribute to faster public access to new medicines.
Activities at the Agency
On request, the Agency can give an opinion on the qualification of the use of a biomarker, to indicate its acceptability for a specific use in pharmaceutical research and development.
- For more information, see qualification of novel methodologies and biomarkers.
The Agency has also concluded a joint qualification process for biomarkers together with the United States Food and Drug Administration (FDA). The qualification followed submission of data by the Predictive Toxicology Consortium (C-Path PSTC) of pharmaceutical companies, and qualified the use of seven biomarkers of drug-induced kidney toxicity in preclinical drug development.
- See the final conclusions on the pilot joint EMEA/FDA VXDS experience on qualification on of nephrotoxicity biomarkers.
The Agency has hosted two workshops on biomarkers in the development of new medicines:
In August 2014 the Agency issued a draft concept paper outlining the key elements to be developed in a guideline on good genomics biomarker practices. This is expected to facilitate the use of genomic data for the development of so-called personalised medicines, the safety monitoring of medicines and the early diagnosis of disease.
- For more information, see Scientific guidelines: pharmacogenomics.
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- Scientific advice and protocol assistance
- Qualification of novel methodologies and biomarkers
- Scientific guidelines: pharmacogenomics