2011 Anniversary Yearbook - EUFEPS today and history

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EUFEPS Newsletter, 2008, vol. 17, issue 1 Innovative Medicines Initiative (IMI) kick-off Ole J. Bjerrum, Professor EUFEPS Past-President The long awaited grants, specially designated for research related to drug development, are within reach. Now that the lists of topics are known, it is timely to form consortia of interested stakeholders beyond the founding EFPIA companies. Current status in a historical perspective The long endeavour to create solid European support for research, as well as education and training, related to the drug development process is almost finished. The kick-off meeting for calls for IMI grants will take place in Brussels on April 30, 2008. Table I shows some of the many events, initiatives and steps that have preceded the present Innovative Medicines Initiative Joint Undertaking (IMI-JU). Various unofficial lists of the EFPIA proposed calls have circulated in Europe since December 2007. The European Commission (EC) kept the books closed so that nobody outside really knew what the end results would be. However, at monthly telephone conferences held in the EUFEPS University Membership Network, the participants have kept each other updated as much as possible on the progress of IMI-related issues. The minutes of those conferences are published on the Network’s website. Finally, on March 3, 2008 when the IMI Governing Board was founded, the list shown in Table II was released from the EC for comments at the interim Member State Contact Group. Once feedback has been incorporated, the final text will be available. Call and peer review process In short the IMI Executive Office will issue calls according to the following mechanism: TABLE I - History of the IMI-JU September 1999 Publication of New Safe Medicines Faster (NSMF) Vision Paper March 2000 First EC funded EUFEPS Workshop on NSMF, Brussels New, safer and more effective drugs” in FP6 March 2002 Launching calls for “Rational and accelerated development of new, safer and more effective drugs” in FP6 April 2003 Second EUREKA funded EUFEPS Workshop on NSMF, Copenhagen April 2003 Application through FP6 of a EUFEPS organised workshop “On creation of biopharmaceutical development platform” (subsequently transformed to an IMI technology platform) November 2003 First contact between EC and EFPIA May 2004 Start of official discussions between EC and EFPIA June 2004 EFPIA agreement to take leadership of the European Technology Platform for Innovative Medicines (IMI) December 2004 Publication of IMI Vision Paper April 2005 EUFEPS organised the Workshop on “How to establish a European Technology Platform for Innovative Medicines”, Barcelona August 2005 Publication of IMI Strategic Research Agenda (SRA) October 2005 Start of the pilot project InnoMed funded under FP6 September 2006 IMI SRA version 2 (Including governance and IP policy) May 2007 Adoption of IMI legal package by the EC August 2007 Adoption of IMI Intellectual Property Policy November 2007 Adoption of IMI legal package by the European Competitiveness Council December 2007 Adoption of the European Parliament opinion December 2007 Approval of the establishment of IMI Joint Undertaking by the European Council December 2007 First EFPIA unofficial IMI calls for Expression of Interests March 2008 Founding of IMI Governing Board April 2008 Announcement of 1st Call for Expression of Interest June 2008? Founding of IMI Member State Contact Group June 2008? Founding of IMI Scientific Committee July 2008? Deadline for Application of Expression of Interests October 2008? Deadline for (final) project applications December 2008? Funding and contract agreements of 1st round of IMI calls LXVIII
• In a first stage, the Executive Office will present a list of topics, application forms and evaluation criteria on the IMI website (www.imi-europe.org) and in relevant scientific journals. Academics, SMEs and Patient organisations, operating in public consortia, will be invited to submit Expressions of Interest (EoI). These will be reviewed by one of the four Standing Peer Review Committees. The first stage will be completed when the EFPIA Consortium asks that the highest ranked Expression of Interest be developed and submitted as a full project proposal. In a second stage, the Public-Private Collaboration (a grouping of the Public Consortia and the EFPIA Consortium) will submit its full project proposal to the IMI Executive Office. In a second peer review round, the relevance and eligibility of the project for each topic will be addressed. Successful projects will then be invited to enter into a grant agreement with the Executive Office. The reviewing of the project follows a transparent peer review process, based on scientific excellence and the applicant’s ability to deliver. The EU’s 7th Framework programme will fund academic participants in Public-Private Collaborations and support SMEs, while the EFPIA-organised companies will fund their own contributions 100%. Other TABLE II - List of titles of the individual calls, duration and allocated funds*) 1. Improve Predictivity of Immunogenicity 5 yr, Euro 13 m 2. Non-genotoxic carcinogenesis 2 + 3 yr, Euro 2.5 + 10 m 3. Expert systems for in silico toxicity prediction 5 yr, Euro 5 m 4. Improved predictivity of non-clinical safety evaluation 3 yr, Euro 10 m 5. Qualification of translational safety biomarkers 5 yr, Euro 21 m 6. Strengthening the monitoring of the benefit/risk of medicines 5 yr, Euro 15 m 7. Islet cell research 5 yr, Euro 10 m 8. Surrogate markers for vascular endpoints 5 yr, Euro 20 m 9. Pain research 5 yr, Euro 7.5 m 10. New tools for the development of novel therapies in psychiatric disorders 5 yr, Euro 10 m 11. Neurodegenerative disorders 5 yr, Euro 7.5 m 12. Understanding severe asthma 5 yr, Euro 12.5 m 13. COPD patient recorded outcomes 5 yr, Euro 10 m 14. European Medicines Research Training Network 7 yr, Euro 5 m 15. Safety sciences for medicines training programme 5 yr, Euro 3 m 16. Pharmaceutical medicine training programme 4 yr, Euro 4 m 17. Integrated medicines development training programme 5 yr, Euro 3 m 18. Pharmacovigilance training programme 5 yr, Euro 3.5 m *) List as of March 3, 2008 types of organisations participating in Public-Private Collaborations will be supported on a case-by case basis. EUFEPS’ role For partnering, EUFEPS may help to organise a kind of fair in connection to one of its conferences during spring 2008. Furthermore, the EUFEPS Secretariat will share information on consortia, as known, under formation with interested researchers who approach EUFEPS. Currently, EUFEPS is engaged in formation of a consortium on “Safety sciences for medicines training programme”. The Secretariat has also received information about potential research projects on biomarkers, safety and pain. How to form consortia At present no official pan-European website exists where the researchers can search for partnering. What initiatives EC will set up in this regard awaits the official calls. However, at the national and regional level many activities and fora for partnering have been launched. It is beyond EUFEPS capacity to keep track on such activities. Here interested parties have to address the local nodes or agencies. LXIX Embark now The pharmaceutical sciences are all pertinent for the IMI topics. For this reason, the majority of the EUFEPS membership should get engaged. If you want to launch a consortium: better start today.
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EUFEPS Yearbook 2011 20 th Annivers
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cal Sciences 2001 2002 2003 2004 20
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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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Croatian Pharmaceutical Society - C
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Hellenic Society of Medicinal Chemi
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Norwegian Pharmaceutical Society No
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Romanian Society of Pharmaceutical
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Swedish Swedish Academy Academy of
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5. Individual Memberships Represent
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B. The membership terminates: • i
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K. The Executive Director shall •
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7. Executive Committee 2010-2011 EU
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8. Advisory Committees Committee on
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9. EUFEPS Networks Scope and aim Th
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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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12. The Pharmaceutical Sciences Fai
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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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Selection of articles from the EUFE
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EUFEPS Newsletter, 1992, vol. 1, is
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Frankfurt. CIR consists of a core g
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Objective 5 To enhance the recognit
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that they have reached the conclusi
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