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Dr. Nicole Schneiderhan-Marra

Biochemie

Tel: 07121 51530-815
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SAFE-T: Biomarker für die Wirkstoffentwicklung

Biomarker sollen die Entwicklung von Pharmaka beschleunigen, indem sie früh und zuverlässig mögliche Organschäden anzeigen.

Projektname: SAFE-T
Safer And Faster Evidence-Based Translation
Projektleiter: Dr. Nicole Schneiderhan-Marra, NMI (Koordinator: Michael MERZ, Novartis Pharma)
Geldgeber: EU
Projektträger: IMI-JU (Innovative Medicines Initiative - Joint Undertaking)
FKZ: 115003
Laufzeit von: 15.06.2009
Laufzeit bis: 14.06.2015

Gemeinsam mit anderen, sowohl klinischen als auch akademischen Partnern und Pharmaunternehmen wird eine Qualifizierungsstrategie für Biomarker entwickelt, die in der Wirkstoffentwicklung eingesetzt werden sollen. Mithilfe der Biomarker sollen medikamentöse Beeinträchtigungen von Leber, Niere und Gefäßen frühzeitig detektiert werden. Das beschleunigt die Auswahl geeigneter Wirkstoffkandidaten und damit den Transfer von Forschungsergebnissen in die Klinik.

Beschreibung

The Consortium composed of complementary partners from EFPIA, SMEs, academic and clinical centers of excellence proposes the SAFE-T (Safer And Faster Evidence-based Translation) project for the establishment of a biomarker (BM) qualification strategy and its validation in clinical BM studies for the translation, performance testing and eventual regulatory qualification of safety BMs for drug-induced kidney, liver and vascular injury (DIKI, DILI and DIVI). SAFE-T objectives will be achieved through innovative biomarker qualification approaches.
The Consortium will deliver a validated generic scientific qualification strategy for translational safety BMs that will be released for discussion to gain public acceptance as a reference guide.
BMs with probable translational utility for DIKI, DILI and DIVI will be qualified for human applications, firstly in exploratory Biomarker Proof of Translation (PoT) studies conducted in small groups of healthy volunteers and patients for proving the translational value of the selected candidates. The performance of selected BMs will be validated in confirmatory Biomarker Proof of Performance (PoP) studies in large patient populations with drug- and non-drug-induced pathologies and with common disorders. On data from clinical studies and validated BM assays, Integrative Data Analysis will be carried out to demonstrate the performance and the added translational-value of BMs in comparison to current gold standards.
BMs will be submitted to the EMEA and FDA to gain approval for certain translational and clinical contexts.
In addition, the biologic/mechanistic understanding of DIKI, DILI, and DIVI-BMs will be investigated for supporting the qualification of translational biomarkers.
The Consortium will establish a project database including human BM profiles and a Biobank for supporting future BM R&D.
SAFE-T will communicate the key results and disseminate this knowledge to identified target audiences via workshops, trainings and media.

Projektpartner

  • Almirall
  • Amgen
  • Argutus Medical Limited (EKF Diagnostics)
  • AstraZeneca
  • Barcelona Cardiovascular Research Center
  • Bayer Healthcare Pharmaceuticals
  • Boehringer Ingelheim
  • Charite Hospital
  • Eli Lilly
  • Experimental & Diagnostic Immunology GmbH
  • Firalis SAS
  • GlaxoSmithKline
  • Groupe d'Etudes et de Recherches en Medecine Interne et Maladies Infectieuses - APHP-1
  • Groupe Hospitalier Pitie Salpetriere - APHP-2
  • Hoffmann La Roche
  • Interface Europe
  • Natural and Medical Sciences Institute
  • Novartis Pharma
  • Pfizer
  • Sanofi-Aventis Research and Development
  • Tel-Aviv (Souraski) Medical Center
  • Universitätsklinikum Aachen
  • University College of Dublin
  • University of Leipzig
  • University of Liverpool
  • University of Malaga

Veröffentlichungen

1. Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study.
M'Kada H, Perazzo H, Munteanu M, Ngo Y, Ramanujam N, Fautrel B, Imbert-Bismut F, Ratziu V, Schuppe-Koistinen I, Leblond V, Delattre JY, Samson Y, Caen OL, Bricaire F, Khayat D, Pierrot-Deseilligny C, Herson S, Amoura Z, Tilleul P, Deckmyn O, Coriat P, Delpech VN, Boulogne P, Bonnefont-Rousselot D, Poynard T; Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière Group; Safer and Faster Evidence-based Translation Consortium.
PLoS One. 2012;7(8):e42418. Epub 2012 Aug 14.

2. A generic operational strategy to qualify translational safety biomarkers.
Matheis K, Laurie D, Andriamandroso C, Arber N, Badimon L, Benain X, Bendjama K, Clavier I, Colman P, Firat H, Goepfert J, Hall S, Joos T, Kraus S, Kretschmer A, Merz M, Padro T, Planatscher H, Rossi A, Schneiderhan-Marra N, Schuppe-Koistinen I, Thomann P, Vidal JM, Molac B.
Drug Discov Today. 2011 Jul;16(13-14):600-8.
doi: 10.1016/j.drudis.2011.04.011. Epub 2011 May 6. Review.

3. What are the best reference values for a normal serum alanine transaminase activity (ALT)? Impact on the presumed prevalence of drug induced liver injury (DILI).
M'Kada H, Munteanu M, Perazzo H, Ngo Y, Ramanujam N, Imbert-Bismut F, Ratziu V, Bonnefont-Rousselot D, Souberbielle B, Schuppe-Koistinen I, Poynard T; DILI group of the SAFE-T consortium.
Regul Toxicol Pharmacol. 2011 Aug;60(3):290-5.
doi: 10.1016/j.yrtph.2011.04.002. Epub 2011 Apr 24.

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