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Introduction to the workshop and EUPATI update
- 1. Eibhlin Mulroe, April2015 European Patients’ Academy: Outline & Status Update The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
- 2. Dublin Workshop Stakeholders- 186 participants
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- 4. Outline of thepresentation Why EUPATI? What is EUPATI? EUPATI Progress Update
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- 6. Health research &policy is changing at a fast pace Innovation transforms the lives of patients with serious, lifelong conditions: Molecular targets/pathways Genome sequencing, Translational research Personalized medicine • Small trial populations • Biomarkers, companion diagnostics Need for post-marketing data Health Technology Assessment, QoL, endpoints, comparators BUT long term pressure on health budgets – here to stay Window of opportunity trial design relationship between researchers, regulators, industry, patients 6
- 7. Patients as partners:partnership model requires a paradigm shift, and more training for patients and advocates Research subject Info provider Advisor Reviewer Co-researcher Driving force Source: PatientPartner FP7 Project (2010) 7 Pre-clinical and clinical research Competent Authorities Policy Makers/Research Policy HTA Agencies/Committees Research Ethics Committees
- 8. There is publicdistrust and a lack of knowledge about research in the lay public Only 6-12% of cancer patients participate in clinical studies 75% of Phase II-IV studies delayed due to slow patient recruitment Bad image one reason for delayed generation of meaningful clinical data
- 9. Public Research Ethics Committees Competent authorities Policy makers /ResearchPolicy HTA agencies & committees Research subject Info provider Advisor Reviewer Co-researcher Driving force Clinical Research Patients have a key role in all aspects of health-related research Trial protocol design, informed consent, ethical review, marketing authorization, value assessment, health policy
- 10. EUPATI is neededbecause… Patients… • seek up-to-date, credible, understandable information about innovation in treatments • are largely unaware about clinical trials, translational research, personalized medicine, pharmaco-economics etc and their key role Patient advocates… • have an increasingly complex and professional task of advising on protocol design, informed consent, ethical review, marketing authorization, value assessment, health policy • are often self-taught and have gaps in the education and training required to participate as an equal partner in medicines R&D Prior to EUPATI the FP7-funded PatientPartner project demonstrated a clear need & willingness of patient advocates to be an active partner in medicines research and development
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- 12. What is EUPATI? A Public Private Partnership within the Innovative Medicines Initiative Joint Undertaking* A 5-year project, launched in February 2012 A patient-led project coordinated by the European Patients’ Forum, with EGAN, EURORDIS and EATG in leadership roles A strong multi-stakeholder consortium of patients’ organisations, academia, NGOs and industry – 30 organisations The key pan-European initiative to build competencies & expert capacity among patients and the health-interested public * Resources are composed of financial contribution from the European Union's Seventh Framework Programme and in-kind and financial contributions from EFPIA companies
- 13. The EUPATI objectivesare directly contributing to this paradigm shift Key objectives: 1. Develop and disseminate objective, credible, correct and up-to-date public knowledge about medicines R&D 2. Build competencies & expert capacity among patients & public 3. Facilitate patient involvement in R&D to collaborate in academic research, industry research, authorities and ethics committees …and NOT: develop indication- or therapy-specific information!
- 14. EUPATI Patient Experts TrainingCourse -- for expert patients EUPATI is developing education targeted at different levels 100 patient experts 12.000 patient advocates 100.000 individuals EUPATI Educational Toolbox -- for patient advocates EUPATI Internet Library -- for the health-interested public English French German Spanish Polish Italian Russian English
- 15. EUPATI Patient Experts TrainingCourse -- for expert patients EUPATI Course, Toolbox and Library: Media and Teaching Tools EUPATI Educational Toolbox -- for patient advocates EUPATI Internet Library -- for the health-interested public Development 2013-2015 Development 2014-2016 Development 2014-2016 e-learning Classroom style face to face teaching Slide shows, factsheets, videos and webinars, glossary 'print ready' content Encyclopaedia Short video documentaries Patient interviews micro-lectures (as podcasts) Images, diagrams
- 16. Topics EUPATI cover 1.Discovery of Medicines & Planning of Medicine Development 2. Non-Clinical Testing and Pharmaceutical Development 3. Exploratory and Confirmatory Clinical Development 4. Clinical Trials 5. Regulatory Affairs, Medicinal Product Safety, Pharmacovigilance and Pharmaco-epidemiology 6. HTA principles and practices +Patients‘rolesand responsibilities 16
- 17. Reflecting European diversity: 7languages, 12 countries 7 most frequently spoken languages: • English • French • German • Spanish • Polish • Italian • Russian 12 countries: UK, Ireland, Malta, France, Luxemburg, the francophone Belgium, Germany, Austria, Switzerland, Spain, Italy and Poland, plus Russian-speaking population in Central and Eastern Europe
- 18. Project led by4 key pan-European patient associations ◦ EUPATI Project Coordination ◦ >50 umbrella patient organisations. ◦ Linking national and regional patient alliances ◦ >600 rare disease organisations in >45 countries ◦ >100 members in over 30 countries Additional partners in other patient organisations and "members of members" via "EUPATI Network"
- 19. Coordinated bypatients (EPF) Leading pan-EU patient umbrella groups involved in all key activities Strong impetus from key academic partners and research organisations Industry expertise in medicines R&D Advisory bodies & codes committed to ensure independence and good governance • EMA, Swissmedic, MHRA, BfArM, AIFA • Key experts in bioethics, genetics, HTA, economics, evidence based med, patient advocacy Strong consortium & strong governance
- 20. Unique andunprecedented partnership • Unique in IMI that EUPATI is patient- and not industry-led • Opportunity to establish an effective, transparent and credible partnership • Exceptional learning experience • Making best use of industry expertise in medicines R&D, incl. Opportunity to strengthen the voice of the patients in the search for innovation and new medicines Chance to reduce fear, lack of trust and misconception among patients regarding the pharmaceutical industry Uniqueness of the partnership
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- 22. Preparation Phase M1-18 Confirmation Phase M19-48 SustainPhase M49-60 WP1 Coordination Project Infrastructure Project Management, Communication, Evaluation, Finances WP2 Network Implem. Establishment of EUPATI Network Public conferences, Regional Workshops, EUPATI Network, EUPATI National Platforms WP3 Needs Assessment & Gap An. Needs analysis, Review of material, focus groups Quantitative survey, Literature review WP4 Content Dev. Syllabus Editorial process, Content Development, translation Refinement, quality control WP5 IT Infrastr. Design, development and support of technical infrastructure for eLearning/IT Platform WP6 Deploy- ment & Quality Assurance First course performed EUPATI IT Platform launch Deployment, dissemination, quality assessm‘t WP7 Sustainability Research on Patient Partnership models Best practice guideline dev., Recommendation of new teaching methods Development of code of conduct for patient involvement Sustainability concept dev. New technologies and future remit strategy Project Plan
- 23. Three years ofEUPATI: Much has been done! … For example events in Frankfurt 2012, Barcelona 2013, Rome 2013, Warsaw 2014…
- 24. EUPATI asesssed patient& public attitudes towards medicines R&D Review of existing information resources; 230 resources reviewed. Review of research literature; 12600 titles and abstracts; 134 studies included Public survey; 6931 responses in GB, Spain, Poland, Italy, France and Germany Qualitative research with patients and the public; n=125 people Qualitative research with stakeholders; n=56 (incl. policy makers, pharmaceutical industry, clinical research professionals) Patient advocate survey; 468 responses across Europe Patient advocate survey focused on course delivery; 41 responses +PeerReviewedPublications
- 25. The EUPATI Network& (Social) Media is growing TOPRA article, coverage in news & blogs ~1.200 „EUPATI Network Members“ >6.500 website visits per month ~1.300 Newsletter subscribers >1.300 Twitter followers; >1.600 tweets >900 Facebook friends >550 LinkedIn members New blog launched Aim to reach 100.000 individuals with your help!
- 26. EUPATI National Platformsare launching The EUPATI National Platforms... ensure EUPATI understands educational needs in R&D on the national level when developing content disseminate EUPATI’s existing training material and information on the national level raise public interest about EUPATI in 12 countries identify training faculty, logistics and financial support on the national level Status: National platforms launched in UK, IE, ES, CH, LUX National liaison teams in FR, IT, MT AT, PL, DE, BE still challenging
- 27. EUPATI at theNational Level – 12 countries What are NLTs and ENPs? EUPATI NATIONAL LIAISON TEAMS are temporary task forces of three members: 1) patients 2) academia 3) industry Teams establish EUPATI NATIONAL PLATFORMS UK IE CH ES FR AT DE IT MT PL LU BE
- 28. EUPATI National LiaisonTeams (NLTs) Characteristics of NLTs Temporary task force 3-8 members Patients, academia, industry Patient-led Terms of reference Volunteers Goal of NLTs develop a country-specific approach for establishing a “EUPATI National Platform” (ENP) ensure EUPATI understand national educational needs share information about EUPATI and raise national interest in EUPATI encourage greater patient involvement in R&D
- 29. EUPATI National Platforms(ENPs) Characteristics of ENPs National network Executive Committee (day-to- day) & Advisory Committee (strategic) Patients, academia, industry and other key local partners (government and regulatory officials, healthcare professionals, media) Patient-led Terms of Reference Volunteers Goal of ENPs raise awareness through national networks and via national media disseminate EUPATI educational and training tools, particularly patients and citizens identify patient involvement topics of national interest develop conditions for the sustainability of EUPATI beyond January 2017
- 30. Country Status Major meetings Spain9 Jan 2012 4 Nov 2014 18 Dec 2014 24 March 2015 Switzerland 13 Jun 2013 4 Feb 2014 11 Dec 2014 25 March 2015 United Kingdom 18 Mar 2013 26 Sept 2013 6 March 2014 Luxembourg 3 April 2013 23 Oct 2013 17 Dec 2014 17 March 2015 Ireland 30 April 2014 16 Sept 2014 Italy 19 Feb 2013 14 Oct 2014 10 April 2015 EUPATI NATIONAL TEAMS & NATIONAL PLATFORMS – WHERE ARE THEY AT? Country Status Major meetings Germany 17 July 2013 Belgium N/A France 22 Feb 2012 21 Jan 2015 16 June 2015 Austria 20 Oct 2014 Malta 30 April 2014 May 2015 Poland 19 Feb 2013 Red: no NLT available Yellow: NLT established, 1st meetings took place, 1st work in common has started Green: NLT well advanced in preparing the establishment of the ENP
- 31. EUPATI NATIONAL TEAMSLAUNCH NATIONAL PLATFORMS Ireland – 16.09.14 Luxembourg – 17.12.14 Italy – 10.04.15 UK – 06.03.14 Spain – 04.11.14 With launches planned for later in 2015…in France, Malta, Poland, Austria and Switzerland!
- 32. Getting conversations goingonline! Bringing partners together! Raising awareness nationally! Twitter Facebook Journals Web articles Radio & TV And much, much more……! Conferences Trainings Workshops Speeches NATIONAL TEAMS & NATIONAL PLATFORMS – WHAT HAVE THEY BEEN DOING?
- 33. First EUPATI’s PatientExperts Training Course kicked off, Oct 2014 e-Learning EUPATI Training Programme 10/2014-11/2015, 9/2015-11/2016Application Phase e-Learning F2F e-Learning F2F Internet Library Toolbox Courses
- 34. Patient Expert TrainingCourse + Online self-learning 150-175 hours of e-learning and 8 days for two Face-to-Face meetings over a period of 14 months + 2 Face-to-face events Patient involvement forum
- 35. The EUPATI e-Learningplatform is already in use with the course launch 35
- 36. Beyond EUPATI: Creating sustainableimpact beyond 2016 EUPATI is developing: New and innovative concepts that will ensure more active involvement of patient experts in R&D and HTA Guidelines for interaction between stakeholders, ethical principles and best practice procedures Guidance on interaction of patient advocates with regulatory, HTA bodies, researchers and industry in the area of medicines research and development
- 37. Jan Geissler [email protected] can reallymake a unique difference to patient empowerment and to medicines R&D. You can help us to make it a success.