(14 Sep 2009)
Launch of the SAFE-T
Consortium under the EU Innovative Medicines Initiative - Joint Undertaking (IMI-JU)
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 will be 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)
PLEASE CLICK HERE FOR A COPY OF THE POSTER PRESENTED AT EUROTOX 2009 SUMMARIZING THE PROJECT GOALS AND ORGANIZATION