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EUFEPS and European Initiatives in Pharmaceutical Sciences

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PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com …

PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com

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  • 1. European Federation for Pharmaceutical Sciences Advances Pharmaceutical Sciences Represents Pharmaceutical Scientists Hans H. Linden May 24, 2007 Dubrovnik, Croatia Established in 1991 1 Hans H. Linden
  • 2. The Mission of EUFEPS “The mission of the European Federation for Pharmaceutical Sciences (EUFEPS) is to serve and advance excellence in the pharmaceutical sciences and innovative drug research in Europe, including in training and education, and to represent the interests of scientists engaged in drug research and development, drug regulation, drug utilisation, and drug policy making.” Strategic Plan 2006-2010 2 Hans H. Linden
  • 3. EUFEPS’ Italy Current Netherlands Individual Members 600+ currently Norway Member Poland Sphere Networks of Expertise Societies in Portugal 8 (member + organisation) Austria Romania Switzerland EU RTD FP6 Consortia Belgium BioSim; InnoMed; Denmark Slovakia EuMapp; IMI Croatia Slovenia Czech Republic Spain Liaisons and Observers Finland Sweden 20+ incl. Student Assoc. France Turkey Germany United Kingdom Greece 24 countries; 16000 “scientific” members Hungary Israel (Asia) Member Institutions 10 currently HUB: Executive Committee Central Office – 2 fulltime Branch Offices 3 Hans H. Linden
  • 4. Current Operations Organisational development and service (membership, committees, networks) Research policy initiatives and coordination (including special workshops) Congresses, conferences and other meetings (from A-Z) Research training and education (courses, database, programmes) Publications (e.g. Eur J Pharm Sci) Transformation of local/national events into European ones (e.g. courses) 4 Hans H. Linden
  • 5. EUFEPS Committees Advisory Committees – Academic Research Relations (CARR) – Industrial Research Relations (CIRR) – Training and Education (CTE) – Awards and Prizes (CAP Programme Committees 5 Hans H. Linden
  • 6. More EUFEPS Committees Steering Committees – In-silico Systems and Learning (SC:ISL) – Meetings and Events (SC:ME) – Membership Development (SC:ME) – Research and Policy (SC:RP) – Training and Education (SC:TE) Executive Committee Supported by … “Branch Offices” and “Central Office” 6 Hans H. Linden
  • 7. Relevant Science Communities Academic Industrial Regulatory Health care settings (asked for) 7 Hans H. Linden
  • 8. The Mission of EUFEPS Instrument – General Bring people together (in small and big groups) around specific or focussed topics, visit with them and arrive at outcomes recommendation reports… 8 Hans H. Linden
  • 9. EUFEPS Meetings 9 Hans H. Linden
  • 10. EUFEPS Meetings 10 Hans H. Linden
  • 11. EUFEPS Meetings EUFEPS Co-sponsor/Organiser of Pre-Satellite PhD Students/PostDocs Main Programme Afternoon Sessions PSWC/PharmSciFair Exhibition Post-Satellite Monoclonal Antibodies Post-Satellite Microdialysis 11 Hans H. Linden
  • 12. EUFEPS Meetings BBBB = Balaton Baltic Bled Bosporus 12 Hans H. Linden
  • 13. EUFEPS Meetings Scientific Progress Underpinning Process Analytical Technology (PAT) November 21-22 • 2006 • Göteborg SE & 13 Hans H. Linden
  • 14. www.pharmscifair.org 14 Hans H. Linden
  • 15. Pharmaceutical Sciences Fair & Exhibition – The PharmSciFair First one ever – June 12-17, 2005, Nice FR Opening Session and 60 more sessions provided by 26 PharmSciFair Partners (13 of them Member Societies of EUFEPS), in 5 days of 5-7 parallel sessions each EUFEPS coordinator of this new European meetings platform and providing 6 sessions (4 “compound profiling” + 2 “biomarkers”) 1255 delegates; 694 scientific contributions (371 posters) and 66 exhibitors (52 commercial) 15 Hans H. Linden
  • 16. PharmSci Fair & Exhibition 2009 16 Hans H. Linden
  • 17. EUFEPS Training and Education Identification of research training needs Courses together with Institutional Partners – E.g. on High-throughput Drug Metabolism Selection of courses for co-sponsorship – E.g. on Quality in Pharma and Biotech Database on Training and Education Courses – for the membership (to be launched) Investigating specialist training programmes – E.g. in Drug Development 17 Hans H. Linden
  • 18. EUFEPS Publications European Journal of Pharmaceutical Sciences (Eur J Pharm Sci) EUFEPS NewsLetter EUFEPS Online (www.eufeps.org) EUFEPS Flash EUFEPS Membership Bulletin EUFEPS Workshop Reports 18 Hans H. Linden
  • 19. European Federation for Pharmaceutical Sciences Advances Pharmaceutical Sciences Represents Pharmaceutical Scientists Established in 1991 19 Hans H. Linden
  • 20. EUFEPS & New Safe Medicines Faster (NSMF)… 1 1998: First initiative in EUFEPS CIRR 2000: Exploratory Workshop and Report 2001: Substantial impact on the EU RTD FP6 2002: Focus in EUFEPS 2002 Congress Expression of Interests for calls collected 2003: Workshop and Report on EUREKA-EU Interest to join projects explored EUFEPS engaging as consortium member in several EU applications 20 Hans H. Linden
  • 21. EUFEPS & New Safe Medicines Faster (NSMF) … 2 2003/ EUFEPS present in 2004: high-level strategy meetings 2004: Brainstorm Workshop on Safety Sciences and Report 2005: Workshop on How to Establish a new European Technology Platform for Innovative Medicines & SRA for FP7 2005/ “Ambassadorship” for follow-up and 2006/ additional input for FP7, plus work in 2007: BioSim, InnoMed; EuMapp consortia 21 Hans H. Linden
  • 22. New Safe Medicines Faster From Ole J. Bjerrum, December 2006 – Learned Society initiative Innovative SRA European Medicines EFPIA Technology New for Europe Platform (JTI) accelerated BIOSIM development Commission FP6 Ambassadorships of medicines EUMAPP GALENOS etc. Position Workshop Workshop Workshop Workshop Workshop Workshop paper 1999 2000 2001 2002 2003 2004 2005 2006 2007 Conferences optimizing drug development Conferences optimizing drug development DRUG 2000 GENAU National European EUREKA FIN AUS Platforms Pharma Sciences Network Safety DRA FIGON ES Leadership Forum Science EFP DK NL DK/S Network Medicines University AU Section Membership IR Critical PAT Top Pharma F Path FDA Network Institute NL 22 US Hans H. Linden
  • 23. IMI Innovative Medicines Initiative 23 Hans H. Linden
  • 24. BioSim Network of Excellence Modern biosimulation techniques Consortium of 40 partners (incl. EUFEPS) 3+ years from December 1, 2004 Developing in silico simulation models of cellular, physiological and pharmacological processes to better understand Basis for a disease-driven drug development process that can lead to biologically designed medicines Integrated with systems approaches and modelling in EUFEPS conferences • Communication with public Training and Education • Information Dissemination 24 Hans H. Linden
  • 25. InnoMed Integrated Project Innovative medicines for Europe Consortium of 44 partners (incl. EUFEPS) 44 months from October 1, 2005 Strategic Research Agenda (SRA) Discovery of new markers for Alzheimer’s Correlation of ‘omics technology results with conventional toxicity data (liver & kidney) 25 Hans H. Linden
  • 26. EuMapp Specific Targeted Research Project EU Microdose AMS Partnership Programme Consortium of 10 partners (incl. EUFEPS) 30 months from November 1, 2005 Human microdosing to predict drugs PK Body of knowledge of science driven approach Ultra-sensitive accelerator mass spectrometry (AMS) In silico modelling applications •Results dissemination • Standardisation • Legislation Volunteer patient concerns and needs • Ethics 26 Hans H. Linden
  • 27. IMI JU Innovative Medicines Initiative Joint Undertaking Challenge to impact on drug discovery and development – for 7 years Unique pan-European public and private sector collaboration in biopharmaceutical research First big pre-competitive collaboration effort Cancer, inflammatory disease, brain disorders, metabolic disease, and infectious disease Commission final decision in mid May 2007 Forwarded to Council and Parliament for approval 27 Hans H. Linden
  • 28. The Innovative Medicines Initiative Strategic Research Agenda focus on the “pre- competitive” bottlenecks in the R&D Process Discovery Preclinical Translational Clinical Pharmaco- research develop. medicine develop. vigilance Knowledge Management Education & Training Benefit/Risk Predictive Predictive Identification Patient Validation of assessment pharmacology toxicology of biomarkers recruitment biomarkers with regulatory authorities Efficacy Safety 4 •From Ian Ragan, December 2006 28 Hans H. Linden
  • 29. EU FP RTD 7 “Tomorrow’s answers start today” Pooling and leveraging resources Fostering human capacity and excellence in science and technology Better integration of European research and development European Union’s main instrument for funding research in Europe in 2007 through 2013 29 Hans H. Linden
  • 30. Global recognition of the problem Innovative Medicines Initiative (EU) Medicamentos Innovadores (Spain) Top Institute Pharma (Netherlands) ECRIN (France) Safety Biomakers (UK) FDA Critical Path Initiative (NIH) Safe and Innovative Medicines (PhRMA) Biomarker Initiative (PhRMA) Critical Path Institute (University of Arizona) Center for Biomedical Innovation (MIT) Toxicogenomics Project (JPMA) Proteome Factory Consortium (JPMA) Large-scale Clinical Trial Network 7 •From Ian Ragan, December 2006 30 Hans H. Linden
  • 31. European Federation for Pharmaceutical Sciences Advances Pharmaceutical Sciences Represents Pharmaceutical Scientists Established in 1991 31 Hans H. Linden
  • 32. New Focus Areas and Membership Networks Safety Sciences – Since 2004 PAT (Process Analytical Technology) Sciences – Since 2004 Bioavailability & Biopharmaceutics – Since 2006 PharmacoGenetics/PharmacoGenomics incl. Personalised Medicines – Since 2006 32 Hans H. Linden
  • 33. Focus Area and Network: Safety Sciences (2004) Follow-up Workshop July 2-3, 2007 April Vienna AT 2004 33 Hans H. Linden
  • 34. Focus Area and Network: Process Analytical Technology (PAT) Sciences (2004) “Manufacturing Science” EuPAT1 – November 2006, Göteborg SE EuPAT2 – November 2007, Copenhagen DK EuPAT3 – November 2008 (?), (?) PharmSciFair Session – June 2009, Nice FR EUFEPS-ISPE “Quality by Design” (QbD) Education and Training for Regulatory Agencies on two levels being explored 34 Hans H. Linden
  • 35. Focus Area and Network: Bioavailability & Biopharmaceutics (2006) Discussion Papers, Concept Papers, Conferences and Projects Sample topics: – Links between in vitro and in vivo variability – Limitations of the BE concept – Impact of different salts on BE assessment – Highly variable drugs – Fixed combination bioequivalence Afternoon Session at PSWC2007 35 Hans H. Linden
  • 36. Focus Area and Network: PharmacoGenetics & PharmacoGenomics (2006) incl. Personalised Medicines Raise (European) funding Improve such research in Europe Contribute to better health (in Europe) through better individualised drug therapy Establish a European Reference Sample for genetic testing Afternoon Session at the PSWC2007 36 Hans H. Linden
  • 37. European Federation for Pharmaceutical Sciences Advances Pharmaceutical Sciences Represents Pharmaceutical Scientists Established in 1991 37 Hans H. Linden
  • 38. European Drug Research and Research Policy Stakeholder Spheres REGULATORY CLINICAL HUB: RESEARCH EMEA HUB: FUNDING INDUSTRY ? HUB: ? HUB: QUALITY & EFPIA LEARNED REFERENCES SOCIETIES & NETWORKS HUB: PATIENTS HUB: EDQM ACADEMIA EUFEPS HUB: HUB: EPF ? 38 Hans H. Linden
  • 39. Towards a European Supra Sphere LEARNED SOCIETIES & NETWORKS Strong REGULATORY QUALITY & Strategic REFERENCES and Coordinating CLINICAL Role ? INDUSTRY ACADEMIA PATIENTS RESEARCH FUNDING 39 Hans H. Linden
  • 40. Priority Spheres LEARNED SOCIETIES & NETWORKS REGULATORY QUALITY & REFERENCES CLINICAL RESEARCH INDUSTRY HUB/Task: Co-ordination ACDEMIA PATIENTS RESEARCH FUNDING 40 Hans H. Linden
  • 41. Executive Committee 1 OJ Bjerrum 5 DJA Crommelin 8 B Aksu 2 H Köszegi-Szalai 6 T Dingermann 9 C Doherty 3 P From 7 CR Noe (Chair) 10 P Vuorela 4 HH Linden 41 Hans H. Linden
  • 42. Structural Approaches & Tasks European European European European European European Pharm Sci Pharm Sci Pharm Sci Pharm Sci Pharm Sci Pharm Sci Academy Forum Train / Ed Fair Workshops Funding refine engage identify gather initiate identify integrate organise define submit outline map position stimulate integrate present produce utilise expand represent meet expose publish develop sciences sci assoc needs results pos papers resources Intellectual Influential Individual Scientific Policy- Enabling authority body careers progress making instrument • Deliverables? • What in what years? • Budgets? 42 Hans H. Linden
  • 43. Structural Approaches & Tasks European European European European European European PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci Academy Forum Train / Ed Fair Workshops Funding refine engage identify gather initiate identify integrate organise define submit outline map position stimulate integrate present produce utilise expand represent meet expose publish develop sciences sci assoc needs results pos papers resources Intellectual Influential Individual Scientific Policy- Enabling authority body careers progress making instrument • Senate • Senators • 50-100 43 Hans H. Linden As of May 2007
  • 44. Structural Approaches & Tasks European European European European European European PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci Academy Forum Train / Ed Fair Workshops Funding refine engage identify gather initiate identify integrate organise define submit outline map position stimulate integrate present produce utilise expand represent meet expose publish develop sciences sci assoc needs results pos papers resources Intellectual Influential Individual Scientific Policy- Enabling authority body careers progress making instrument • Senate • Leadership Forum • Senators • Presidents • 50-100 • Currently 10 44 Hans H. Linden As of May 2007
  • 45. Forum Initiative & Invitation Meeting in Vienna AT – June 11, 2006: Agreement to go Meeting in Leiden NL – October 1, 2006: Letter of Intent drafted Meeting in Amsterdam NL – April 23, 2007: Presentation and discussion 45 Hans H. Linden
  • 46. European Pharma Sciences Leadership Forum - EuPSLF EACPT European Association of Clinical Pharmacology and Therapeutics EAPB European Association of Pharma Biotechnology ECRIN European Clinical Research Infrastructures Network EFB European Federation of Biotechnology EFMC European Federation of Medicinal Chemistry ELSO European Life Science Organisation EPHAR Federation of European Pharmacological Societies ESCP European Society of Clinical Pharmacy ESF/EMRC European Science Foundation/European Medicines Research Councils (?) EUFEPS European Federation for Pharmaceutical Sciences EUROTOX European Federation of Toxicologists & European Societies of Toxicology FEBS Federation of European Biochemical Societies GA Society for Medicinal Plant Research 46 Hans H. Linden
  • 47. European Federation for Pharmaceutical Sciences www.eufeps.org secretariat@eufeps.org Hans H. Linden, EUFEPS PO Box 1136 SE-111 81 Stockholm, Sweden Tel +46 8 7235025; +46 708 799813 hans.linden@eufeps.org Established in 1991 47 Hans H. Linden
  • 48. Structural Approaches & Tasks European European European European European European PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci Academy Forum Train / Ed Fair Workshops Funding refine engage identify gather initiate identify integrate organise define submit outline map position stimulate integrate present produce utilise expand represent meet expose publish develop sciences sci assoc needs results pos papers resources Intellectual Influential Individual Scientific Policy- Enabling authority body careers progress making instrument • Senate • Leadership Forum • Meetings & Events SC • 2nd 2009 with Partners • Senators • Presidents • 50-100 • Currently 10 • EUFEPS Committee/s 48 Hans H. Linden As of May 2007
  • 49. Structural Approaches & Tasks European European European European European European PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci Academy Forum Train / Ed Fair Workshops Funding refine engage identify gather initiate identify integrate organise define submit outline map position stimulate integrate present produce utilise expand represent meet expose publish develop sciences sci assoc needs results pos papers resources Intellectual Influential Individual Scientific Policy- Enabling authority body careers progress making instrument • Will follow… • Senate • Leadership Forum • Meetings & Events SC • 2nd 2009 with Partners • Senators • Presidents • 50-100 • Currently 10 • EUFEPS Committee/s 49 Hans H. Linden As of May 2007
  • 50. “Networking is imperative!” 1 EUFEPS Networks of Individual Members EUFEPS Network of Member Societies EUFEPS Network of Member Institutions European Forum of Presidents of Scientific Communities – Relevant for Drug Discovery, Development and Utilisation (EuPSLF) European Senate of Distinguished Scientists in Pharmaceutical Sciences (to be established) FIP Board of Pharmaceutical Sciences 50 Hans H. Linden
  • 51. “Networking is imperative!” 2 EU FP RTD Consortia – InnoMed – BioSim – EuMapp BBBB Conference Series Leading Group PharmSciFair Programme Providing Partners & Clusters & Planning Team World Events Organising Committees 51 Hans H. Linden
  • 52. Current Strategic Focal Points* Focus on Innovation – NSMF; IMI; PharmSciFair; new networks/platforms Focus on Quality – Pharmaceutically okay (wherever produced) – Therapeutically meaningful (for desired outcome) – Rationally manufactured (efficient processes) Focus on Responsibility – Improved competence and professionalism (personal) – Local, regional and global collaboration (political) – Medicines “for Europe and the World” (industrial) * EUFEPS Strategic Plan 2006-2010 52 Hans H. Linden
  • 53. Current Finance and Funding 2007 Membership Dues Royalty of Eur J Pharm Sci (EJPS) Support by SAPS, TI Pharma and University of Vienna, respectively Conference and Course Income EU Project Funding Sponsorship by companies A “EUFEPS Fund” (being established) 53 Hans H. Linden
  • 54. Why invest more in EUFEPS? To underpin the only pan-European body for pharmaceutical/drug scientists (whatever origin, domain or discipline) To proactively support systems approaches in European collaboration, co-operation and co-ordination for better drug research and development To further strengthen the European voice and platform for needs and progress communication along with beneficial networking Efficient organisation 54 Hans H. Linden
  • 55. European Federation for Pharmaceutical Sciences www.eufeps.org secretariat@eufeps.org Hans H. Linden, EUFEPS PO Box 1136 SE-111 81 Stockholm, Sweden Tel +46 8 7235025; +46 708 799813 hans.linden@eufeps.org Established in 1991 55 Hans H. Linden