2011 Anniversary Yearbook - EUFEPS today and history

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EUFEPS Newsletter, 1999, vol. 8, issue 3 New Safe Medicines Faster A Proposal for a Key Action within the European Union’s 6 th Framework Programme Ole J. Bjerrum, Professor Chair EUFEPS/CIR Task Force on EU Framework Programme The budgets of European RTD Framework Programmes have steadily increased over the years. They now count for approx. 5% of public spending on research in Europe. Every 4th year, a new Framework Programme, including various key actions and generic activities, is launched. Through a bottom up process it should theoretical be possible to influence the contents of future framework programmes. The issue of getting impact is very complex and involves many players - including you. Important measures To get involved in the future EU RTD Framework programmes the following exercises are needed as a minimum: • a well defined, thoroughly described research area covering many European stakeholders • a plan and the commitment to carry it through • a presentation of the proposal to the Commission • further substantiation and refinement of the proposal through discussion at specially arranged workshops and conferences in an interactive play with the Commission • heavy support from all the stakeholders at the EU member state level to convince their respective governmental bodies including their research ministers about the value of the proposal. The EUFEPS Committee on Industrial Relations (CIR) have decided to bring the pharmaceutical sciences in focus to EU’s 6th Framework Programme 2003–2007, under the title “New Safe Medicines Faster”. The rationale is the following: The global competitiveness of the European pharmaceutical industry is under threat. Technology currently available for the development of new medicines is unable to match the pace of drug discovery and design; and the ever-growing demand for safety, efficacy and quality documentation has increased the cost and time involved in getting new medicines on the market thus creating severe restrictions on industry’s ability to create wealth and launch safe, cost effective drugs for the treatment of common and rare afflictions. Clear objectives The present proposal is based on three main objectives: to develop new technologies capable of more effective selection of potential drug candidates for innovative medicines while accommodating safety demands; to use such technologies to speed up the pharmaceutical development and eliminating foreseeable bottlenecks, created by the many drug candidates now generated in the discovery phase. Furthermore to cultivate a pan-European interdisciplinary network on science and training that bridges the gap between industry and academia. By breaking down the barriers put up by the legislation of individual nations, and initiating a new set of recognised European standards, new medicines can be brought onto the market faster and thereby cheaper — thus benefiting European health care. The key action A key action is an excellent way of creating consortia of research groups representing all the specialist areas involved in drug development — pharmacology, toxicology, pharmaceutics, scale-up processing, analytical chemistry and clinical trials. A new and important discipline, pharmacogenomics, will XXII also play a major role in the future when determining the effect of specific drugs on individual patients. In addition, the key action should comprise clusters, centres of excellence, programmes for specialist training and dedicated support for small and medium-sized enterprises. Methodologies and technologies Promoting and implementation of new methodologies and technologies are a major issue. Work on these aspects should include as many of the pharmaceutical sectors and EU member states as possible. As a result, the new pharmaceutical methods, techniques, tools and procedures that emerge will more easily obtain broad international approval and, at the same time, represent the most competitive solutions for increasing the speed, cutting the cost and improving the quality of drug development. The new front-line methodologies often derive from basic sciences, such as molecular genetics, biomedicine, bioengineering and information technology. Also techniques related to robotics and miniaturisation in pharmacology and pharmaceutics and structure activity relations in absorption, distribution, metabolism and excretion studies and toxicology will contribute to faster, more efficient drug development, as can the auxiliary disciplines of analytical and processing chemistry. Education and training A highly qualified work force is also important. PhD and post-graduate students trained in up-to-date technologies and research areas will help to close the current gap between academia and the needs of industry. The present deficiencies are thought to be due to the small size of individual faculties, a lack of academic
and industrial integration and inadequate post-doctoral programmes. But, through training and mobility measures, the key action provides a basis for solving these problems by combining top level university research with front-line technology in areas where there is little or no training in Europe today. Concerted effort Thus a concerted effort put forward by the key action “New Safe Medicines Faster” has clear benefits that speak loudly in favour of its inclusion in the EU’s 6th Framework Programme. By crossing the divide between individual fields of research and development, industry and academia and transforming drug development into an integrated process, the European pharmaceutical industry will be better equipped to tackle the health and employment challenges of the future. First step taken The first version of the Proposal has been approved by the EUFEPS’ Executive Committee, and copies of it were submitted to the DG XII of the European Commission, and to EFPIA, to get their early comments and support. In the year to come, the collaboration on this with EFPIA will be expanded, as well as with others, to improve the proposal and solidify the arguments with data and facts. Furthermore, the scientific content of the work programme of the key action should be worked out. To support this process, dedicated workshops will be arranged. Additional involvement welcome Support of this Proposal is needed XXIII also from you as member of the local pharmaceutical research communities at universities, industries, and hospitals. Only you can convince research councils and research administration bodies in relevant ministries of your country about the value of this Proposal. Please bear in mind that it is your Minister in the European Council who in the very end decides the fate of this initiative. The full text of the EUFEPS/CIR Proposal can be obtained from the EUFEPS Secretariat, and CIR will welcome any comment to the Proposal itself, or to this Editorial, through the EUFEPS Secretariat.
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EUFEPS Yearbook 2011 20 th Annivers
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Pharma Ingredients & Services Custo
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The Gamlen Tablet Press The world
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2. PRESIDENT’S INTRODUCTION Democ
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4. Member Societies Academy of Phar
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