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Profiling the toxicity of new drugs: a non animal-based approach integrating toxicodynamics and biokinetics

Objective

The overall aim of Predict-IV is to develop strategies to improve the assessment of drug safety in the early stage of development and late discovery phase, by an intelligent combination of non animal-based test systems, cell biology, mechanistic toxicology and in-silico modelling, in a rapid and cost effective manner. A better prediction of the safety of an investigational compound in early development will be delivered. Margins-of-safety will be deduced and the data generated by the proposed approach may also identify early biomarkers of human toxicity for pharmaceuticals. The results obtained in Predict-IV will enable pharmaceutical companies to create a tailored testing strategy for early drug safety. The project will integrate new developments to improve and optimize cell culture models for toxicity testing and to characterize the dynamics and kinetics of cellular responses to toxic effects in vitro. The target organs most frequently affected by drug toxicity will be taken into account, namely liver and kidney. Moreover, predictive models for neurotoxicty are scarce and will be developed. For each target organ the most appropriate cell model will be used. The approach will be evaluated using a panel of drugs with well described toxicities and kinetics in animals and partly also in humans. This approach will be highly advantageous as it will allow a direct comparison between the in vivo to the in vitro data. A parallel analysis of several dynamic and kinetic models with a broad spectrum of endpoints should allow for the identification of several relevant biomarkers of toxicity. Inter-individual susceptibilities will be taken into account by integrating the polymorphisms of the major drug metabolizing enzymes and correlating the observed effects in the human cell models with their genotype. Environmental influences on cellular toxicity to these compounds will also be evaluated using hypoxic stress as a relevant test model.

Field of science

  • /natural sciences/biological sciences/cell biology
  • /medical and health sciences/basic medicine/toxicology
  • /natural sciences/biological sciences/biochemistry/biomolecules/proteins/enzymes
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/drug safety

Call for proposal

FP7-HEALTH-2007-A
See other projects for this call

Funding Scheme

CP-IP - Large-scale integrating project

Coordinator

JULIUS-MAXIMILIANS-UNIVERSITAT WURZBURG
Address
Sanderring 2
97070 Wuerzburg
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 638 469
Administrative Contact
Christian Gloggengiesser (Mr.)

Participants (19)

Merck KGaA
Germany
EU contribution
€ 873 974
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stefan Mueller (Dr.)
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 918 216
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tea Milosevic (Ms.)
ISTITUTO SUPERIORE DI SANITA
Italy
EU contribution
€ 436 152
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
Administrative Contact
Rosa Maria Martoccia (Dr.)
INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS
France
EU contribution
€ 446 167
Address
Parc Technologique Alata
60550 Verneuil En Halatte
Activity type
Research Organisations
Administrative Contact
Fabienne Mathieu-Gouteyron (Mr.)
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
EU contribution
€ 148 326
Address
Rue De La Loi 200
1049 Brussels
Activity type
Research Organisations
Administrative Contact
Raymond Crandom (Dr.)
EMERGENTEC BIODEVELOPMENT GMBH
Austria
EU contribution
€ 875 160
Address
Gersthofer Strasse 29-31
1180 Vienna
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Bernd Mayer (Dr.)
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 800 496
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Armin Wolf (Prof.)
KaLy-Cell
France
EU contribution
€ 548 380
Address
Rue Du Général Leclerc
67115 Plobsheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Nasser Bidani (Mr.)
UNIVERSITE DE RENNES I
France
EU contribution
€ 352 512
Address
Rue Du Thabor 2
35065 Rennes Cedex
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yolaine Bompays (Ms.)
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Ireland
EU contribution
€ 482 652
Address
Belfield
4 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Donal Doolan (Mr.)
UNIVERSITEIT UTRECHT
Netherlands
EU contribution
€ 369 347
Address
Heidelberglaan 8
3584 CS Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Monique M. Hoek, Van Der (Dr.)
CERTARA UK LIMITED
United Kingdom
EU contribution
€ 245 199
Address
One London Wall 6Th Floor
EC2Y 5EB London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Amin Rostami (Dr.)
FREIE UNIVERSITAET BERLIN
Germany
EU contribution
€ 268 928
Address
Kaiserswerther Strasse 16-18
14195 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Susi Uezel (Ms.)
UNIVERSITE DE LAUSANNE
Switzerland
EU contribution
€ 471 862
Address
Quartier Unil-centre Bâtiment Unicentre
1015 Lausanne
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Honegger (Prof.)
UNIVERSITE D'ARTOIS
France
EU contribution
€ 395 811
Address
Rue Du Temple 9
62000 Arras
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Martine Courty (Ms.)
DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG
Germany
EU contribution
€ 346 784
Address
Im Neuenheimer Feld 280
69120 Heidelberg
Activity type
Research Organisations
Administrative Contact
Bettina Crispin (Ms.)
UNIVERSITAET ROSTOCK
Germany
EU contribution
€ 551 202
Address
Universitatsplatz 1
18055 Rostock
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dieter G. Weiss (Prof.)
NEUROPROOF GMBH
Germany
EU contribution
€ 311 173
Address
Friedrich Barnewitz Str 4
18119 Rostock
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olaf Schröder (Dr.)
PARIS-LODRON-UNIVERSITAT SALZBURG
Austria
EU contribution
€ 850 096
Address
Kapitelgasse 4-6
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Christian Huber (Prof.)