Background

 

The SAFE-T consortium is the first project having started under the framework of the EU Innovative Medicines Initiative-Joint Undertaking (IMI JU), a unique public private partnership between the European Communities and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations [EFPIA]).

The goal of the new EC initiative is to reinvigorate the biopharmaceutical sector in Europe and overcome the research bottlenecks in the drug development process. One of the areas targeted is patient safety. Drug toxicity is a major cause of costly late-stage development failures and devastating market withdrawals. Traditional preclinical toxicology approaches have limited power to detect adverse effects in human and to evaluate relevance of preclinical findings to the clinical setting. Species differences in drug toxicity in preclinical safety tests, the lack of sensitive translational biomarkers and non-representative patient populations in clinical trials are probable reasons for the failures in predicting human drug toxicity. However, changes in drug discovery practices and the implementation of specific and sensitive Safety Biomarkers are expected to decrease considerably these drug development failures.

The SAFE-T consortium is working together with the aim of qualifying safety biomarkers for drug-induced kidney, liver and vascular injury in translational studies and seeking acceptance of health authorities for these biomarkers for use in clinical trials during drug research and development. Furthermore, these novel biomarkers have clinical use for better diagnosis of kidney, lung and vascular diseases.

 

  Kidney: Current diagnostic tests (Serum Creatinine, BUN) are only increased when 50-60% of the kidney function is lost. Kidney injury leads to a permanent impairment of the kidney function (chronic kidney disease) as the kidney is an organ with low regeneration capability.
 

Liver: Current standards (AST, ALT, Bilirubin) are not specific and do not predict who will recover and who will develop fulminant liver disease

 

Vascular System: There are currently no biomarkers to monitor drug-induced vascular injury in human