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SAFE-T Consortium under the EU Innovative Medicines Initiative (IMI) - First Year of Active Collaboration

Faster Development of Safer Medicines through Translational Safety Biomarkers.

The SAFE-T Consortium has been working together for a year now. The project addresses the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury of the kidney, liver and vascular system, which is a major hurdle in drug development. The SAFE-T objective of qualifying new translational safety biomarkers is expected to enable potential new medicines to be evaluated more quickly and safely in patients. Daily care in clinical units should also benefit from this project, as these safety biomarkers are expected to support the patient's treatment in order to prevent organ injuries on drug therapy.

The first year of this unique 5-year partnership of the European Pharmaceutical Industry, Academics and Small and Medium Enterprises was characterised by fruitful cooperation. At first, a generic scientific strategy was developed to define the qualification process of new translational safety biomarkers that will allow early identification, assessment, and management of drug-induced injuries throughout drug research and development. Common approaches and standard operating procedures were created which serve as a solid basis for next steps in assay development and biomarker qualification, and will ensure high common quality levels throughout all partner sites.

Furthermore, potential biomarker candidates for drug-induced injury of the kidney, liver and vascular system were evaluated and prioritized for clinical qualification. The chosen biomarkers require a variety of different assays for analysis. Thus, the initial step was to assess assay and reagent availability for the selected candidate biomarkers; assay development for the biomarker candidates (proteins, metabolites and RNA molecules) for translation studies has now been initiated.

As SAFE-T aims at providing statistically-based evaluations and evidence via integrative data analysis of each study for biomarkers qualification and linking the database with SAFE-T biobank sample repository, detailed requirements have been established for a project database and biobank in the first year. Standard operating procedures for sample handling and storage and all necessary documents for patient codification and correct sample tracking have been prepared.

Briefing documents for obtaining scientific advice from health authorities, such as European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), were prepared and submitted. The SAFE-T exploratory-phase plans of qualifying novel biomarkers for kidney and liver injuries were reviewed by, and discussed with EMA and FDA. The exploratory-phase plan for qualification of vascular injury biomarkers will be presented to the health authorities in October this year. EMA also contributes to the project as an external advisor. After the final stage of the project, the data will be submitted to the EMA, FDA and the Japanese PMDA agency who will be asked to issue a regulatory opinion regarding the qualification of the novel biomarkers for use in defined clinical contexts.

In summary, SAFE-T is working according to plan and has made considerable progress during the last 12 months. The main achievement during this year is the development of a productive collaboration between the partners from EFPIA, academia and SMEs that resulted in the planned project deliverables, such as lists of prioritised biomarkers for DIKI, DILI and DIVI, biomarker assays and defined biomarker qualification strategies.

SAFE-T has recently launched its website that gives more detailed information on the project http://imi-safe-t.eu SAFE-T consortium members are: - Almirall - Amgen - Argutus Medical Limited (formerly Biotrin) - AstraZeneca - Barcelona Cardiovascular Research Center - Bayer Schering Pharma - 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 - Pfizer - Sanofi-Aventis Research and Development - Tel-Aviv (Souraski) Medical Center

For more information about SAFE-T, please contact: Michael Merz, Coordinator of SAFE-T, (michael.merz@novartis.com) Ina Schuppe Koistinen, Scientific Coordinator of SAFE-T (ina.schuppe-koistinen@astrazeneca.com)

idw :: 16.06.2010

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