introduction to the workshop and eupati update
TRANSCRIPT
Eibhlin Mulroe, April 2015
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.
Health research & policy is changingat 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 ofopportunity trial design relationship
between researchers, regulators, industry, patients
6
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
There is public distrust and a lack of knowledge about research in the lay public
Only 6-12% of cancer patientsparticipate 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
Public
Research Ethics Committees
Competent authorities
Policy makers/Research Policy
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 policyAre there enough patient
advocates to engage in R&D?
EUPATI is needed because…
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 demonstrateda clear need & willingness of patient advocates to be an active partner in medicines research and development
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
The EUPATI objectives are 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!
EUPATI Patient ExpertsTraining Course-- for expert patients
EUPATI is developing education targeted at different levels
100 patient
experts
12.000patient advocates
100.000individuals
EUPATI Educational Toolbox-- for patient advocates
EUPATI Internet Library-- for the health-interested public
English FrenchGermanSpanishPolishItalian Russian
English
EUPATI Patient ExpertsTraining Course-- 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
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
+ P
atients‘ roles and responsibilities
16
Reflecting European diversity: 7 languages, 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
Project led by 4 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"
Coordinated by patients (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
Unique and unprecedented 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
Preparation PhaseM1-18
Confirmation PhaseM19-48
Sustain PhaseM49-60
WP1 CoordinationProject
Infrastructure
Project Management, Communication,
Evaluation, Finances
WP2Network 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
groupsQuantitative survey,
Literature review
WP4 Content Dev. SyllabusEditorial process,
Content Development, translation
Refinement, quality control
WP5 IT Infrastr.
Design, development and support of technical infrastructure for eLearning/IT Platform
WP6 Deploy-ment & QualityAssurance 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 ofcode of conduct
for patient involvement Sustainability concept dev. New technologies and future remit strategy
Project Plan
Three years of EUPATI:Much has been done! …For example events in Frankfurt 2012, Barcelona 2013, Rome 2013, Warsaw 2014…
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
+ P
eer
Rev
iew
ed P
ublic
atio
ns
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!
EUPATI National Platforms are 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
EUPATI at the National 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
UKIECHESFRATDEITMTPLLUBE
EUPATI National Liaison Teams (NLTs)
Characteristics of NLTsTemporary task force3-8 members Patients, academia, industryPatient-ledTerms of referenceVolunteers
Goal of NLTsdevelop a country-specific approach for establishing a “EUPATI National Platform” (ENP) ensure EUPATI understand national educational needsshare information about EUPATI and raise national interest in EUPATIencourage greater patient involvement in R&D
EUPATI National Platforms (ENPs)
Characteristics of ENPsNational networkExecutive Committee (day-to-day) & Advisory Committee (strategic)Patients, academia, industry and other key local partners (government and regulatory officials, healthcare professionals, media)Patient-ledTerms of ReferenceVolunteers
Goal of ENPsraise awareness through national networks and via national mediadisseminate EUPATI educational and training tools, particularly patients and citizensidentify patient involvement topics of national interest develop conditions for the sustainability of EUPATI beyond January 2017
Country Status Major meetings
Spain 9 Jan 20124 Nov 201418 Dec 201424 March 2015
Switzerland 13 Jun 20134 Feb 201411 Dec 201425 March 2015
United Kingdom
18 Mar 201326 Sept 20136 March 2014
Luxembourg 3 April 201323 Oct 201317 Dec 201417 March 2015
Ireland 30 April 201416 Sept 2014
Italy 19 Feb 201314 Oct 201410 April 2015
EUPATI NATIONAL TEAMS & NATIONAL PLATFORMS –WHERE ARE THEY AT?
Country Status Majormeetings
Germany 17 July 2013
Belgium N/A
France 22 Feb 201221 Jan 201516 June 2015
Austria 20 Oct 2014
Malta 30 April 2014May 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
EUPATI NATIONAL TEAMS LAUNCH 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!
Getting conversations going online!
Bringing partners together!
Raising awareness nationally!
Journals
Web articles
Radio & TV
And much, much more……!
Conferences
Trainings
Workshops
Speeches
NATIONAL TEAMS & NATIONAL PLATFORMS – WHAT HAVE THEY BEEN DOING?
First EUPATI’s Patient Experts Training Course kicked off, Oct 2014
e-Learning
EUPATI Training Programme10/2014-11/2015, 9/2015-11/2016Application
Phase
e-Learning F2F e-Learning F2F
Internet Library
Toolbox
Courses
Patient Expert Training Course
+
Online self-learning
150-175 hours of e-learning
and 8 days for two Face-to-Face meetingsover a period of 14 months
+
2 Face-to-face events Patient involvement forum
Beyond EUPATI: Creating sustainable impact 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
can really make a uniquedifference to patient
empowerment and to medicines R&D.
You can help us to make it a success.