PREDICT-IV
Profiling the toxicity of new drugs: a non animal-based approach integrating toxicodynamics and biokinetics
| Coordinatore | JULIUS-MAXIMILIANS UNIVERSITAET WUERZBURG
Organization address
address: SANDERRING 2 contact info |
| Nazionalità Coordinatore | Germany [DE] |
| Totale costo | 16˙426˙328 € |
| EC contributo | 11˙330˙906 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2007-A |
| Funding Scheme | CP-IP |
| Anno di inizio | 2008 |
| Periodo (anno-mese-giorno) | 2008-05-01 - 2013-10-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
JULIUS-MAXIMILIANS UNIVERSITAET WUERZBURG
Organization address
address: SANDERRING 2 contact info |
DE (WUERZBURG) | coordinator | 0.00 |
| 2 |
Nome Ente NON disponibile
Organization address
address: KAPITELGASSE 4-6 contact info |
AT (SALZBURG) | participant | 0.00 |
| 3 |
DEUTSCHES KREBSFORSCHUNGSZENTRUM
Organization address
address: Im Neuenheimer Feld 280 contact info |
DE (HEIDELBERG) | participant | 0.00 |
| 4 |
EMERGENTEC BIODEVELOPMENT GMBH
Organization address
address: GERSTHOFER STRASSE 29-31 contact info |
AT (VIENNA) | participant | 0.00 |
| 5 |
FREIE UNIVERSITAET BERLIN
Organization address
address: Kaiserswertherstrasse 16-18 contact info |
DE (BERLIN) | participant | 0.00 |
| 6 |
INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS
Organization address
address: Parc Technologique Alata contact info |
FR (VERNEUIL EN HALATTE) | participant | 0.00 |
| 7 |
ISTITUTO SUPERIORE DI SANITA
Organization address
address: Viale Regina Elena 299 contact info |
IT (ROMA) | participant | 0.00 |
| 8 |
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Organization address
address: Rue de la Loi 200 contact info |
BE (BRUSSELS) | participant | 0.00 |
| 9 |
KALY-CELL
Organization address
address: RUE ALAIN SAVARY 18 contact info |
FR (BESANCON) | participant | 0.00 |
| 10 |
MEDIZINISCHE UNIVERSITAET INNSBRUCK
Organization address
address: Christoph-Probst Platz 1 contact info |
AT (INNSBRUCK) | participant | 0.00 |
| 11 |
MERCK KGAA
Organization address
address: Frankfurter Strasse 250 contact info |
DE (DARMSTADT) | participant | 0.00 |
| 12 |
NEUROPROOF GMBH
Organization address
address: FRIEDRICH BARNEWITZ STR 4 contact info |
DE (ROSTOCK) | participant | 0.00 |
| 13 |
NOVARTIS PHARMA AG
Organization address
address: LICHTSTRASSE 35 contact info |
CH (BASEL) | participant | 0.00 |
| 14 |
SIMCYP LIMITED
Organization address
address: LEAVYGREAVE ROAD 40 contact info |
UK (SHEFFIELD) | participant | 0.00 |
| 15 |
UNIVERSITAET ROSTOCK
Organization address
address: UNIVERSITATSPLATZ 1 contact info |
DE (ROSTOCK) | participant | 0.00 |
| 16 |
UNIVERSITE D'ARTOIS
Organization address
address: RUE DU TEMPLE 9 contact info |
FR (ARRAS) | participant | 0.00 |
| 17 |
UNIVERSITE DE LAUSANNE
Organization address
city: LAUSANNE contact info |
CH (LAUSANNE) | participant | 0.00 |
| 18 |
UNIVERSITE DE RENNES I
Organization address
address: RUE DU THABOR 2 contact info |
FR (RENNES CEDEX) | participant | 0.00 |
| 19 |
UNIVERSITEIT UTRECHT
Organization address
address: Heidelberglaan 8 contact info |
NL (UTRECHT) | participant | 0.00 |
| 20 |
UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN
Organization address
address: BELFIELD contact info |
IE (DUBLIN) | participant | 0.00 |
Mappa
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Obiettivo del progetto (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.'
Introduzione (Teaser)
Rapid drug development in the pharmaceutical industry is log-jammed due to the complexities involved in toxicity testing. Besides being expensive and time consuming, large amounts of test compounds and animals are required.
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