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.

Dublin Workshop Stakeholders - 186 participants

Dublin Workshop Countries

Outline of the presentation

Why EUPATI?

What is EUPATI?

EUPATI Progress Update

Why EUPATI?

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

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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)

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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?

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

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atients‘ roles and responsibilities

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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

EUPATI Progress Update

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

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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!

Twitter

Facebook

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

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Online self-learning

150-175 hours of e-learning

and 8 days for two Face-to-Face meetingsover a period of 14 months

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2 Face-to-face events Patient involvement forum

The EUPATI e-Learning platform is already in use with the course launch

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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

Jan Geisslerjan@patientsacademy.eu

can really make a uniquedifference to patient

empowerment and to medicines R&D.

You can help us to make it a success.