Consortium
The SAFE-T consortium is a unique public-private partnership that brings together pharmaceutical companies, universities, hospitals and biotechnology SMEs to share and validate each other's safety testing methods under advisement of the European Medicines Agency (EMA) and its US counterpart, the Food and Drug Administration (FDA). To generate enough clinical evidence for qualifying new safety biomarkers for pre-clinical and clinical regulatory decision-making needs full stakeholder cooperation of the following 20 consortium members:The SAFE-T consortium is a unique public-private partnership that brings together pharmaceutical companies, universities, hospitals and biotechnology SMEs to share and validate each other's safety testing methods under advisement of the European Medicines Agency (EMA).
To generate enough clinical evidence for qualifying new safety biomarkers for pre-clinical and clinical regulatory decision-making needs full stakeholder cooperation of the following 20 consortium members:
SMEs
- Argutus Medical Limited (Argutus)
- Experimentelle Diagnostische Immunologie GmbH (EDI)
- Firalis SAS (FIRALIS)
- Interface Europe Sprl (IE)
Academic Partners
- Consorci Institut Català de Ciències Cardiovasculars (ICCC)
- Charité Universitätmedizin Berlin (Charité)
- Assistance Publique – Hôpitaux de Paris (APHP)
- Natural and Medical Sciences Institute (NMI)
- Tel-Aviv Souraski Medical Center (TASMC)
EFPIA members, Pharmaceutical Companies
- Novartis Pharma AG (Novartis)
- Laboratorios Almirall SA (Almirall)
- Amgen NV (Amgen)
- AstraZeneca (AZ)
- Bayer Schering Pharma AG (BSP)
- Boehringer Ingelheim International GmbH (BI)
- Eli Lilly and Company Ltd (ELI)
- GlaxoSmithKline Research and Development Limited (GSK)
- Pfizer Ltd (Pfizer)
- F. Hoffmann - La Roche AG (Roche)
- Sanofi Aventis Research and Development (SARD)
Collaborators
- Critical Path Institute’s PSTC consortium
- Centre for Drug Safety Science at Liverpool University
- Málaga University (UMA)
- Spanish DILI Registry
External Advisors
- European Medicines Agency (EMA)