SAFE-T Press Release; September 14, 2009

Faster Development of Safer Medicines through Translational Safety Biomarkers

The Safer And Faster Evidence-based Translation consortium (SAFE-T) announces the start of work to qualify biomarkers for drug-induced kidney, liver and vascular injury in translational studies and seek for regulatory acceptance in translational and clinical contexts.
The SAFE-T project has been publicly presented at the EUROTOX 2009 conference in Dresden on September 14, 2009. The SAFE-T consortium is a public private partnership between 20 participants from the pharmaceutical industry, small-medium enterprises, academic institutions and clinical units of excellence with representatives from the health authorities EMEA and FDA as external observers and advisors to the consortium.
The consortium will be 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 human, which is a major hurdle in drug development. Therefore, many promising candidate drugs with pre-clinical 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.
The consortium will develop promising preclinical biomarkers to detect drug-induced kidney, liver and vascular injury in humans using peripheral samples such as blood and urine. In pre-clinical and clinical studies evidence about their utility and limitations will be collected to seek approval by health authorities for their use in drug development. Daily care in clinical units will also benefit from this biomarker qualification project, as these safety biomarkers are expected to support the diagnosis of liver, vascular and kidney diseases and to help clinical management of patients susceptible to organ injury.
The total budget of the consortium will be 35.8 M€, over a total duration of five years, with combined financing from the participating European pharmaceutical companies and the IMI JU for academic partners and SMEs (the completion and signature of the Grant Agreement with the IMI-JU is pending).
After finalization of the project agreement, the project started on June 15, 2009 with an inaugural meeting in Stockholm. The SAFE-T consortium is the first project to start under the EU IMI-JU, a unique public private partnership between the European Communities (represented by the European Commission) and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations [EFPIA]). IMI’s objective is to support projects that address the main causes of delay, or "bottlenecks", in the pharmaceutical research and development process. More information about IMI is provided at http://imi.europa.eu.

SAFE-T consortium members are:
• Almirall
• Amgen
• Argutus Medical Limited (formerly Biotrin)
• AstraZeneca
• Barcelona Cardiovascular Research Center
• Bayer Schering Pharma AG
• Boehringer Ingelheim
• Charité Hospital
• EDI GmbH
• Eli Lilly
• Firalis SAS
• GlaxoSmithKline
• Groupe Hospitalier Pitié Salpêtrière
• Hoffmann La Roche
• Interface Europe
• NMI Natural and Medical Sciences Institute at the University of Tuebingen
• Novartis Pharma AG
• Pfizer
• Sanofi-Aventis Research and Development
• Tel-Aviv (Souraski) Medical Center

For more information about SAFE-T, please contact:
• Frank Dieterle, Coordinator of SAFE-T, (frank.dieterle@novartis.com)
• Ina Schuppe Koistinen, Scientific Coordinator of SAFE-T (ina.schuppe-koistinen@astrazeneca.com)