European Patients Academy
on Therapeutic Innovation
http://www.patientsacademy.eu – [email protected]
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.
Medical landscape 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


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Need for post-marketing data
Health Technology Assessment,
QoL, endpoints, comparators
Healthcare budgets
Window of
opportunity
 trial design
 relationship
between
researchers,
regulators,
industry,
patients
2
Unmet need of patient & public,
great willingness to contribute!

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Patients…
• seek up-to-date, credible, understandable information
about innovation in treatments
• are largely unaware about clinical trials, translational
research, personalized medicine, pharmacoeconomics,
their key role
Patient advocates…
• like to advise on protocol design, informed consent,
ethical review, marketing authorization, value
assessment, health policy
• lack the education and training required to participate
as a partner in drug research and development
FP7-funded PatientPartner project demonstrated
a clear need & willingness to contribute
Patients' organisations key role in
building a new environment for the
development of new medicines

Patient‘s organisations have unique
insights in „real life“ and „real needs“ of
patients:
• Gap analysis in research priorities
• Clinical trial design
• Priority setting
• Research policy
Driving force
Co-researcher
Reviewer

Training required to get expertise
required to contribute to medicines
research & development (R&D) projects
Advisor
Info provider
Research subject
Source: PatientPartner FP7
Project (2010)
4
The Patients‘ Academy addresses
unmet needs
European Patients' Academy on Therapeutic Innovation is…


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initiated and led by key European Patient Advocacy
organisations
the key European initiative to develop and provide objective,
credible, correct and up-to-date public knowledge about
medical research
a paradigm shift in empowering patients and the public to
understand medical research and how to contribute to it
a strong multi-stakeholder consortium of patient
organisations, academia, NGOs and industry
Audiences: advocacy leaders
and the public at large
EUPATI Certificate Training Programme

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Academic Modular Certificate Programme
Patient Ambassadors in committees, R&D teams, …
Patient Journalists raising awareness
Patient Trainers for patient communities & networks
EUPATI Educational Toolbox


Educational tools for patient advocates
Variety of distributable formats: Paper-based booklets,
presentations, eLearning, webinars, videos etc.
100
patient
advocates
12.000
patient
advocates
EUPATI Internet Library


Patients & lay public at large, e.g. on specific aspects of
the development process of medicines for patients with
low (health) literacy.
Wiki, YouTube, films and/or cartoons
100.000
individuals
Within the next 5 years, the
Patients‘ Academy will…

develop and disseminate accessible, well-structured
and user-friendly information and education on
medicines R&D

build expert capacity by training patient advocates,
and competencies among patients and the public

create the leading public library on medicines R&D:
7 languages, “creative commons” license

facilitate patient involvement in
R&D to partner up with academia,
authorities, industry, ethics committees
…and NOT:
develop indicationor therapy-specific
information!
Reflecting European diversity:
7 languages, 12 countries

7 most frequently spoken languages:
English, French, German, Spanish, Polish,
Italian, Russian

Serving 12 European countries:
UK, Ireland, Malta, France, Luxemburg, the francophone
Belgium, Germany, Austria, Switzerland, Spain, Italy and
Poland,
plus Russian-speaking population in CEE
Areas covered by
the Patients’ Academy
1.
Medicines development process
from research to approval
2.
Personalised and predictive medicine
3.
Drug safety and risk/benefit assessment of medicines
4.
Pharmaco-economics, health economics and health
technology assessment
5.
Design and objectives of clinical trials
(& roles of stakeholders)
6.
Patients roles & responsibilities in
medicines development
…and NOT:
develop indicationor therapy-specific
information!
Multi-Stakeholder
Consortium

Led by pan-EU patient umbrella
organisations

Strong impetus from key
academic partners and non-profit
organisations

Key industry expertise in how
medicines R&D works
10
Project led by 4 key pan-European
patient associations

European Patients Forum
 EUPATI Project Coordination
◦ >50 umbrella patient organisations. Through
'members of members', potential outreach
to 150 million patients

European Genetic Alliance Network
◦ Linked with national and regional patient
alliances in Germany, Eastern Europe, Italy,
Netherlands, United Kingdom and Ireland,
Sweden, Spain, Italy, Greece and Balkan
countries

EURORDIS – Rare Diseases Europe
◦ Representing >500 rare disease
organisations in >45 countries

European AIDS Treatment Group
◦ More than 100 members in over 30
countries.
Additional
partners in other
patient
organisations
and "members
of members"
via
"EUPATI
Network"
Ensuring Objectivity, Transparency
and Independence are vital

Advisory bodies committed to ensure
independence, transparency, good
governance
• EMA, Swissmedic, MHRA, BfArM
• Key experts in bioethics, genetics, HTA,
economics, evidence based med,
patient advocacy
• Ethics Panel

Ethical Framework, Code of Conduct:
• Ground rules for anonymity, confidentiality,
informed consent, social research, ethical
review, professional integrity, publication
ethics, transparency, independence and trust.
Uniqueness of the partnership

Unique and unprecedented partnership between patient
organisations, other public partners and pharmaceutical industry
based on the philosophy of the IMI
• Unique in IMI that EUPATI is patient- and not industry-led
• Opportunity to establish an effective, transparent and
credible partnership
• Exceptional learning experience for industry representatives
to work with patient organisations in a constructive and
reflective manner, which could serve as a role model in other
environments as well
• Making best use of industry expertise in medicines R&D,
incl. e.g. the legislative environment and development of ITP as
required by law

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
Public license model guarantees
fit-for-purpose re-use by the public

What we bring in and what we produce
will be owned by the public

EUPATI material will be provided under the
"Creative Commons License"
• Content can be copied, distributed, edited, remixed, and
built upon, all within the boundaries of copyright law on
non-commercial basis
• Authorship and licensing needs to stay intact and
mentioned on all derivatives
• Similarly applied by e.g. WikiPedia, Google,
Whitehouse.gov and many others
See http://creativecommons.org/licenses/by/3.0/
EUPATI in 2016:
What we will have achieved

EUPATI platform fully loaded with training, education,
information material in multiple languages

EUPATI Patient Ambassador, Patient Journalist,
Train-the-Trainer Programme in place

Good practice guideline for patient involvement released

Annual Conferences and at least 5 regional Workshops
performed. Expert network established.
Get to know us!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as: