“SAFE-T Consortium is a unique partnership of the European Pharmaceutical Industry, Academics and Small and Medium Enterprises who are working together to qualify translational safety biomarkers for drug-induced kidney, liver and vascular injury to enable potential new medicines to be evaluated more quickly and safely in patients.”


Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) collaborate on development of important new drug safety tests
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SAFE-T Consortium meeting in Stevenage (UK), 29-31 October 2013
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About SAFE-T

SAFE-T is working to address the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury to the kidney, liver and vascular systems in man, which is a major hurdle in drug development.

Therefore, many promising candidate drugs with pre-clinical kidney, liver or vascular toxicity signals of unknown relevance do not enter the clinical phase, as no sensitive tests exist to allow timely detection of patient safety signs before irreversible injury occurs. New tests based on biomarkers will enable studies to assess whether these drugs are safe to ‘translate’ into clinical use. Furthermore, the new translational safety biomarkers will allow the identification and management of side effects of drugs throughout drug development helping to reduce the risk of developing medicines and improving the safety management of patients.

SAFE-T work generally falls under the goal of creating methods to enable personalised medicines that improve public health.


Quick facts

Biomarker : a measure of a normal biological process in the body, a pathological process, or a response of the body to a therapy

25 active partners


6-year project

Total Budget of 35.7 million Euros

13.9 million Euros as IMI JU contribution

17.6 million Euros as EFPIA contribution