Scientific and technological issues in alternatives research in drug development and Union politics START-UP The START-UP project concerns the identification and proposals to abolish bottlenecks in the 3Rs approach in pharmaceutical discovery and development. The goal of the project is organising 3 Workshops to determine the state of the art of each of the 3Rs in the EU, assess European strength and gaps in 3Rs and identify rate limiting steps on a scientific and technological level, resulting in a Consensus Paper containing concepts and suggestions for a Road Map for future research. Stakeholders (among them European Pharmaceutical Industries) have identified bottlenecks in drug development and in the integration of in vitro methods. Early identification of wrong candidates for further development and avoiding efforts for under-performing candidates are essential for the competitiveness of European Industry. Identification of bottlenecks in the implementation of the 3Rs in drug R&D should help identifying the best in vitro and in vivo systems, and to speed up the drug development process. Existing hurdles in the scientific, technological, ethical, regulatory and political level, play a substantial role and are rate-limiting in developing new drugs, including biological entities. The project is structured around 3 Workshops, preceded by 2 Expert Meetings redefining and prioritising current bottlenecks in 3Rs methodology, drug discovery and development. The limitations and gaps of each phase will be addressed, e.g. many cell systems do not have the required stability for genomics, proteomics or metabonomics ; many current cell systems lack crucial bioactivation capability. Thus, the status of satisfactory “predictive” pharmacology and toxicology in vitro has not yet been reached. The final goal is a Consensus Document .Thereupon, a Road Map to implement the strategy for a better integration of 3Rs in the EU drug discovery and development strategy will be proposed.
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