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Scientific and technological issues in alternatives research in drug development and Union politics

Final Report Summary - START-UP (Scientific and technological issues in alternatives research in drug development and Union politics)

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 basis of the START-UP project was the general intention to cover all the issues of 3Rs-bottlenecks in pharmaceutical research and development (R&D), as represented by the abbreviation, i.e. scientific and technological issues in 3Rs alternatives research in the process of drug development and European Union politics. In order to have as much coverage as possible, the area was intensively analysed in expert meetings, predominantly of industry, but also of academia, and regulatory authorities. Later on, in the second year of the project, these closed expert meetings were extended to three open workshops on each of the 3Rs.

The results were presented and found entrance into the discussions; the format varied, intentionally, from brain storming sessions and working group style to formal scientific presentation workshops or plenum style forums to enable free and interactive communication. All presentations and discussions are detailed in report form and are accompanied by an executive summary and a list of specific recommendations. The major outcome is present here as an overall executive summary, followed by the most prominent recommendations and a road map.

In this their final report they show that, in summary, the European Comission's Seventh Framework Programme project START-UP has delivered a whole landscape of ideas and potential avenues for further research and development projects within the future Framework Programme in regard to 3Rs bottlenecks and European industry competitiveness; these should be considered when drawing up new project calls in this area in the future. It has been demonstrated that only detailed discussions with experienced experts can lay groundwork for adequate analysis.