EUPATI – European Patients Academy Matthew May EUPATI Programme Coordinator 05 May 2017

Mission: Empowering patients for their key role in health-related research Competent authorities Policy makers /Research Policy Public Research subject Info provider Advisor Reviewer Co-researcher Driving force Clinical Research Research Ethics Committees HTA agencies & committees

Patient involvement in medicines R&D Protocol synopsis Trial Steering Committee Information to participants Setting research priorities Data MonitoringCommittee Protocol design Regulatory Affairs Investigator meetings High expertise in disease area required Research Priorities Research design and Planning Research conduct and operations Dissemination Communication Post-approval Ethics Review Study Reporting Patient Information Fundraising for research Post-Study Communication Medium expertise in disease area required Informed Consent Practical Considerations Health Technology Assessment

Public-Private-Partnership

EUPATI is addressing three audiences: The plan EUPATI Patient Experts Training Course -- for expert patients 100 patient experts >170.000 users to date 2 courses done, 96 Fellows Different approach 10 languages English EUPATI Educational Toolbox -- for patient advocates 12.000 patient advocates English French German Spanish Polish Italian Russian EUPATI Internet Library -- for the health-interested public 100.000 individuals

Training leaders and creating a movement…

Two EUPATI Courses: Mission accomplished! 96 graduates completed the two courses 58 disease areas, 31 countries 3rd course to start in September 2017 Ingrid K

EUPATI Fellows has created influencers and leaders Role Before Course EUPATI Post Course Member of patient organisation, not actively involved 17% 2% Active role in a patient organisation 62% 71% Leadership role in a patient organisation Employee of a patient organisation 25% 23% Volunteer role in a patient organisation 60% 67% Presenting at conferences, workshops etc. 63% 83% Advising a pharmaceutical company 13% 44% Advising a regulatory agency 21% 42% Advising a reimbursement agency 4% 8% We have surveyed 52 of the 83 fellows that had completed the two courses until last week. If you compare their roles and activities before they started with our course, and after they completed the course, you can see that the course has encouraged them to take a leadership role in advocacy, and many of them have then started to advise pharma companies, regulatory agencies or HTA bodies as patient experts. Source: The EUPATI Fellow Experience Poll, December 2016, 52 respondents (83 fellows)

Educating the wider community…

EUPATI Toolbox on Medicines R&D in 10 languages: Huge demand In English, French, Italian, Spanish, German, Polish, Russian, Dutch (2 more to come) >168.000 unique users from 149 countries (Jan 16 –May 2017)

EUPATI Toolbox on Medicines R&D: >3.500 content items PowerPoints Articles The Toolbox is not just a medicines R&D Encyclopedia, it can be a tool for self-learning, or it can be a tool for teaching others, for trainers. With this in mind, we’ve included tools in a range of formats, to try and suit as many audiences as possible. As a result you will find: Articles [short description] PowerPoints [short description] Infographics [short description] Factsheets [short description] In the coming months, we hope to also add XX, XX, and XX. Infographics Fact sheets

EUPATI Mini-Course Starter Kits to run training days Core set of PPT slides in specific area of patient involvement, plus links into EUPATI Toolbox, Case Studies + Trainers Manual! Research design and Planning Research Priorities Research conduct and operations Dissemination Communication Post-approval Setting research priorities Protocol synopsis Protocol design Trial Steering Committee Information to participants Data MonitoringCommittee Investigator meetings Regulatory Affairs Fundraising for research Practical Considerations Patient Information Informed Consent Ethics Review Study Reporting Health Technology Assessment Post-Study Communication

EUPATI Mini-Course Starter Kits to run training days

Making sure it’s right…

EUPATI Production & Review Process: Don’t tell us we’ve made our lives easy!

Creating networks on the country level…

18+ EUPATI National Platforms bring all stakeholders together in countries address educational needs in R&D disseminate EUPATI’s training material to patient organisations National platforms set up in AT, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT Additional platform initiatives ongoing in BE, NO, GR, RO, SRB

Providing guidance and frameworks…

EUPATI Guidance for patient involvement and interaction – Why? Overarching guidance on meaningful and ethical interaction is missing in many areas, especially in R&D Existing codes/regulations hold mostly legal & ethical content, i.e. collaboration, communication, funding Do not cover patient involvement in R&D e.g. EFPIA, EATG code, PCWP framework, ECAB, EMA framework, HTAi Language needs to be more directive towards patient involvement Clear default statement that collaboration is allowed unless expressly forbidden

EUPATI Guidances are supporting patient interaction in R&D and regulatory affairs Following an extensive consultation of the community, EUPATI has developed guidances for the interaction of patient organisations… in industry-led R&D with HTA bodies in regulatory processes in ethics committees See EUPATI.eu > Resources > Guidances or http://eupati.eu/guidances

The “New” EUPATI Programme EPF-led, permanent programme in the PPP spirit 3rd EUPATI Patient Expert Training Course EUPATI Toolbox in all languages “Mini-Course Starter Kits” and capacity building Content updates (~10 Toolbox elements updated p.a.) National Platforms Evolution! Jan G IMI Call 1: not funded 2-stage application, consortium building EUPATI IMI Project 2012-2016: patient-led PPP of patients, academia, NGOs and industry EUPATI Programme 2010 2011 2012 2013 2014 2015 2016 2017 2018

A new PPP

Web: www.eupati.eu Twitter: @eupatients as well as: