EU and industry-funded researchers have gathered data on new biological indicators that could help to identify - accurately and early - the potential side effects of certain drug treatments. The research could help speed up drug development and improve diagnoses and patient care.
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Drug side effects are not always predictable and if detected too late can put health and lives of patients at risk. Pharmaceutical companies often plough millions of euros and years of work into drug development, only to have to abandon their efforts due to unforeseen side effects. Accurately predicting, detecting and monitoring drug-induced injuries could save both money and lives.
In response, the EU and industry-funded SAFE-T project successfully generated a vast amount of data on 105 initial biomarker candidates, of which more than 20 have showed promising performance in testing for drug side effects.
Biomarkers are things we can measure in the human body, explains SAFE-T project coordinator Michael Merz, formerly of Novartis. Blood for example contains a great deal of information about the patient. What we dont always have are biomarkers that can tell if certain side effects will occur in a patient, or what the mechanisms underlying side effects of a drug might be.
The results have since received a boost from the European Medicines Agency (EMA) and the American Food and Drug administration (FDA), which have since issued letters of support encouraging additional exploration and data generation.
Data on new biomarkers molecules that we can measure in the blood or urine will allow us to detect drug side-effects earlier and more accurately than has been feasible in the past, says Merz. These biomarkers will also improve diagnosis and monitoring in chronic disease patients. This will help medical staff make better decisions on specific treatment alternatives, such as when to stop treatment.
In addition, a biobank with serum, plasma and urine samples from more than 11 000 patients across 19 different populations has been established. A subset of the samples in the biobank is available for use by other researchers. Similarly, a biomarker database will also support further research on drug-induced injuries.
The project is funded by the Innovative Medicines Initiative, a public-private partnership between the EU and the European pharmaceutical industry.
Future of drug development
SAFE-T focused on addressing drug-induced injury in three areas: the kidneys, the liver and the vascular system.
For decades, the key biomarker used for kidney disease was increasing only after the organ had been substantially damaged; in other words, too late, says Merz. We need more sensitive biomarkers that tell us much earlier if any damage is being done to the kidney.
Biomarkers for liver have to date not been specific enough, which means that serious health issues that can arise might not necessarily be drug induced. This means that medical professionals and researchers are often unable to accurately assess the side effects of a particular drug. There has also been a lack of suitable biomarkers for the vascular system.
The discovery of potential new biomarkers for drug-induced injuries in these three organs therefore represents an important breakthrough. The letters of support from EMA and the US FDA will help to promote the use of these biomarkers in further exploratory research.
Our biomarkers may also be of value when it comes to areas such as transplant rejection, but there is still a lot of work to be done, says Merz. Thats why were now planning new projects and initiatives. A follow up project is expected to start early next year.
SAFE-T has also led to the creation of spin-off companies, one of which is focused on developing immune assay technology.
The biomarkers could also be applied to non-drug related diseases, like chronic kidney disease and hepatitis, adds Merz. In the future we might be able tell earlier and more reliably which patients may develop chronic liver disease, or who might require a transplant.