2011 Anniversary Yearbook - EUFEPS today and history

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EUFEPS Newsletter, 2006, vol. 15, issue 1 New Safe Medicines Faster European Technology Platform Strategic Research Agenda Innovative Medicines for Europe EU Joint Technology Initiative Ole J. Bjerrum, Professor EUFEPS Immediate Past-President Support to pharmaceutical research in the European Union under Framework Programme 7 will now be in the form of public-private partnerships through the Innovative Medicines Initiative (IMI). The snowball started by EUFEPS´ New Safe Medicines Faster initiative, in 1999, has grown exponentially. All the terms given in the title above prove this. The initiative is now so large that EUFEPS can no longer be in the eye of the movement. Other forces have joined and indeed given the initiative the necessary muscles, but EUFEPS will still be in the loop. There are still many loose ends and uncertainties, but due to the created momentum, further development will not stop. The current situation is described below. New Safe Medicines Faster (NSMF) The NSMF concept still stands, as does the need to increase the capacity of and to shorten the drug development process. It is even more valid today than when the first Position Paper was written. Now the activities to fulfil the original goals have got new branding and promoters but the stakeholders together with their organisations remain the same: industry, regulators, academia, the clinical sector and patients. The NSMF initiative fulfilled its role when it had a direct influence on Framework Programme 6 through the many calls for research projects conducted in relation to the drug development process. Thus the NSMF concept is still in our thinking when EUFEPS plans or engages in new activities, but the acronym NSMF has, in the European context, been overtaken by the IMI. This stands for the new Innovative Medicines Initiative. European Technology Platforms (ETP) One major objective for the European Union is to build the most competitive and dynamic knowledge-based economy in the world by 2010. A key element of this objective is the strengthening of the science base in Europe through FP7. Since the biopharmaceutical environment is characterised by its focus on science and innovation, it is essential to revitalise this area to become more competitive. One of the instruments to be used in this connection has been the Technology Platform concept covering the major industrial sectors in Europe. The pharma industry represents such a key area and Dr. Fergal Donelly, from DG Research of the EU Commission, presented the first concept for a pharmaceutical Technology Platform at the EUFEPS/APGI conference on Material Science in Versailles in 2003. However, the original Technology Platform concept has lost some of its appeal, as the financing of the ETP would come through a Joint Technology Initiative. Strategic Research Agenda (SRA) To engage the pharmaceutical industry in a JTI, the Commission invited the European Federation of Pharmaceutical Industries and Associations (EFPIA) to work out a Strategic Research Agenda (SRA), describing the necessary research to be carried out in public-private partnerships to secure the future competitiveness of the pharmaceutical industries in Europe. In this connection, during Spring of 2005, the stakeholders have discussed the strategic pharmaceutical research needed for Europe, through 13 workshops organised by EFPIA together with one organised by EUFEPS (all paid for by the Commission). L For EUFEPS, it is encouraging to see that most of the precompetitive research topics suggested in the SRA correspond to those published in the preceding EUFEPS reports on New Safe Medicines Faster (cf. www.EUFEPS.org). They concern development of in vitro, in vivo and in silico models predictive of clinical efficacy and safety, stimulation of translational medicine, validation of biomarkers and new clinical trial designs as well as sharing of core reference databases. The first draft for the SRA was published on July 27, 2005. The SRA was further considered during Autumn 2005, when additional workshops were organised to reinforce the SRA in the following areas: pharmacovigilance, infectious diseases, SMEs and finance. On basis of the incoming comments, the final SRA is close to publication. However, it should be noted that the final governance structure of the IMI initiative is still under discussion. Innovative Medicines Initiatives (IMI) This initiative, also named Innovative Medicines for Europe, is the heir to NSMF. The content is based on the Strategic Research Agenda, which is divided into 4 sections regarding Safety, Efficacy, Knowledge Management and Education & Training. One project has already been implemented from December 1, 2005, as an Integrated Project under FP6 namely INNOMED. It has 44 Consortium Members and is supported with 14 Mio. Euros from the Commission. EUFEPS is participating but does not receive any EU grants. The project is intended to validate the ETP concept through two research projects:
• NeuroMed, which will develop and validate novel surrogate markers based upon in vitro and in vivo models in animal and humans, using Alzheimer´s disease as a testing platform. • PredTox will deliver new biomarkers of toxicity and a greater understanding of mechanisms of toxicity. The experience gained here will be used in the Joint Technology Initiative for Innovative Medicines in Europe under FP7. EU Joint Technology Initiative (JTI) A Joint Technology Initiative, via Art. 171 of the EC Treaty, should finance the Innovative Medicines Initiative, with its SRA and ETP. However, this does not happen automatically as 6 JTIs are currently competing; Innovative Medicines, Aeronotics, Hydrogen and Fuel Cells, Embedded Systems, Nano Electronics, GMES (Global Monitoring for Environment and Security). The decision will be taken by a “Competitiveness Council” of all European Research Ministries, later this year. Their decision will be based on; • European added value • Inability of existing instruments to achieve their objectives • Degree and clarity of definition of objectives to be pursued • Strength of financial/resource commitment by industry • Contribution to broader policy objectives • Scale of the impact on industrial competitiveness and growth The IMI JTI is high on the priority list, but nothing is certain. Therefore it needs your support, see Mirror Platforms below. The overall intentions for the JTI on Innovative Medicines are to; • provide a mechanism for rapid and systematic take up, evaluation and translation of research results into new methods and techniques for use in the medicines development process • facilitate the provision of advice by regulators for setting up “tailor made” validations • provide “neutral ground” for the necessary collaboration between all stakeholders, thereby removing the suspicions of “biased collaborations” that undermine collaborations today • foster the development of a new «tool- box» (toxicology tests, biomarkers, clinical trials protocols, etc.) for drug developers to reduce the risk of failure during clinical trials • provide the infrastructure for validation of the new tools in view of rapid uptake into regulatory and industry practice • set up ‘knowledge platforms’ pooling data from toxicology testing and biomarker validation, which will be available to all researchers (industry and academic) Since the necessary R&D cannot be done by any one member of the stakeholders group alone, the IMI will facilitate the participation of all stakeholder groups in the research, following open calls and peer review. Research can be done by “anybody” as long as it is carried out in Europe. At the present stage, March 2006, the EU money allocated to FP7 are expected to be considerably less than originally anticipated. So instead of 400 Mio. Euro per year, the Commission works with a plan where they allocate 50 Mio. Euro in the first year, followed by an increase in subsequent years, when money becomes more abundant in the EU system. The money will be given to public-private partnerships where industry pays for all of their own costs and the Commission pays for the rest. The industry has bound itself to spend the same amount of money as the Commission per year. Proposed governance structure of the IMI JTI The IMI JTI Board shall be composed by the Founding Members (EC and EFPIA) and by potential new funding members. The Executive Office is responsible for day-to-day management regarding the implementation of the SRA. The Scientific Committee is an advisory body to the Board. Collectively it shall have the competencies to cover the complete drug development process and have a balance composition of academia, patients, industry and regulatory representatives. In particular it shall advise on the continued relevance of the SRA and review the scientific achievements of the SRA implementation and advise the board accordingly. Finally it shall advise on the composition of the peer review committees. The Stakeholder Forum should be LI open to all stakeholders and convene annually. It shall ensure the openness and transparency of IMI and it can provide strategic advice to the Board. The Member States Group shall approve the composition of Scientific Committee. It shall facilitate rapid dissemination of information and ensure co-ordination with national activities. Especially it shall be responsible for the implementation of Education and Training. It is noteworthy that the organisation of the Stakeholder Forum is so vaguely presented. This leaves room for European organisations linked to the drug development process to act on this stage. Conventional support through FP7 If the JTI for Innovative Medicines is adopted at its intended scale, one should not expect to see many calls specifically related to the pharmaceutical research in the ordinary FP7. However, it will still be possible to apply for general instruments like Marie Curie fellowships etc. Mirror Technological Platforms In parallel to the European Innovative Medicines Initiative, corresponding regional and national platforms have been established in Denmark-Sweden, The Netherlands, Spain, France and Romania. In this connection, it is important that all researchers engaged in pharma in one way or another support these initiatives; indicating to the national governments that there are local researchers, who will step in, if their respective ministers support the JTI on Innovative Medicines. In this way, your personal effort can strengthen the pharmaceutical sciences in Europe and vice versa. Conclusion The NSMF initiative has grown in size and importance, but it has also been substantially added to and changed branding, appearing under a new name: Innovative Medicines Initiative (IMI). Still the decisive step of significant funding has not yet been taken, for which reason I appeal to all EUFEPS membership not to lose any opportunity to promote and support the idea in your local environment: namely that Europe needs the Innovative Medicines Initiative to compete in the global arena for pharmaceuticals. Together we can do it!
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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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Sustainable sponsorship of EUFEPS g
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2. PRESIDENT’S INTRODUCTION Democ
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4. Member Societies Academy of Phar
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Network Environment and Pharmaceuti
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10. Awards and Prizes EUFEPS is, si
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The New Safe Medicines Faster Award
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14. EUFEPS in EU Projects Since est
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16. EUFEPS on the Global Scene Sinc
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17. Sponsorship Recognition The cor
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