VITROCELLOMICS - Reducing Animal Experimentation in Preclinical Predictive Drug Testing by Human Hepatic In Vitro Models Derived from Embryonic Stem Cells (Life sciences, genomics and biotechnology for health) (2006-01-01 - 2008-12-31) (»add to infobox)

The objective of the proposal is to establish stable cell lines that reliably reflect human hepatic properties by the development of models derived from human embryonic stem cells (hESC). The aim is to deliver reliable in vitro models that can be used by the pharmaceutical industry to replace experimental animals in investigations on human drug metabolism, uptake and efflux properties of compounds in the drug discovery and development processes. In the pharmaceutical industry reliable in vitro cell models would replace current techniques and animal experimentation in the selection and optimisation of lead compounds and in documentation of a selected drug candidate before it enters clinical phases. The means to accomplish the objective are in addition to hESC derived hepatocytes, (1) 3D-hepatic cell methods, (2) micro-cultivation monitoring for in vitro screening, (3) genomic and metabolomic characterization, and (4) a multi-micro-bioreactors for high-throughput screening of drug candidates. Comparative studies with established in vitro models will be carried out to validate the new models/methods. The outcome of the project is new pre-validation models which will reduce the use of animal experimentation for prediction of human drug metabolism and disposition by 60-80%. In addition, the models will also increase safety and quality of compounds chosen as candidates in the different stages of the drug discovery and development process. Furthermore, it will strengthen the possibility for SMEs to market new potential products for assays and in vitro screening. The clinical expertise in the project includes two renowned European university hospitals, one SME founded by another European university hospital, and a larger pharmaceutical company. The coordinator and several partners have a background from pharmaceutical industry which is paired with partners very experienced in bioengineering.

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