To make the European industry competitive in a global market we need in vitro test systems that support business needs by being mechanism based, relevant to man and able to handle many samples simultaneously (high throughput screens).
Major obstacles which stand in the way of industry are our lack of understanding of the basic cellular mechanisms involved in toxicity and a shortage of suitable cell lines and cryopreserved tissues. There is also a clear need for high-throughput screens for detecting toxicity.
These limitations could be overcome by encouraging EU-funding into basic research, the provision of phenotypically-stable, immortalised cell lines, and access to well-characterised cryopreserved primary cells and tissues (including human and non-human primate).
The development of high throughput screens for detecting toxicity are an absolute necessity for all areas of toxicity testing. The development of such screens is seen as a long term goal, which requires substantial fundamental research into the mechanism of toxicity. Screens should be designed in such a way that they can be performed using a few molecules only of the test compounds.
In addition, the development of in vitro tests might be one of the tools to reduce, refine or replace the number of animal tests commonly used in research or required by regulatory authorities. Industry would be pleased if the near future would bring a 'toolbox', or a set of methods and approaches, which is acceptable from a scientific, and regulatory point of view.
Whatever the rationale to develop in vitro tests, they should be based on sound scientific principles and have a high predictive value.
Industry wishes to encourage a novel approach to in vitro test system development. Emphasis should be on an understanding of the fundamental mechanisms that these systems are intended to model. Only with such an understanding we might be able to develop the predictive tests that have, so far, eluded us using an empirical approach.
In all research projects, creativity of scientists should not be hindered by the constraints of industrial application. However, the following general criteria should be considered when developing in vitro test systems for industrial and regulatory acceptance. Test systems should: