European Patients Academyon Therapeutic Innovation

http://www.patientsacademy.eu – info@patientsacademy.eu

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 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 Healthcare budgets

Window ofopportunity trial design relationship

between researchers, regulators, industry, patients

2

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 demonstrateda clear need & willingness to contribute

Unmet need of patient & public, great 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

Training required to get expertise required to contribute to medicines research & development (R&D) projects Research subject

Info provider

Advisor

Reviewer

Co-researcher

Driving force

Source: PatientPartner FP7 Project (2010) 4

The Patients‘ Academy addresses unmet needs

European Patients' Academy on Therapeutic Innovation is…

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

EUPATI Certificate Training Programme Academic Modular Certificate Programme Patient Ambassadors in committees, R&D teams, … Patient Journalists raising awareness Patient Trainers for patient communities & networks

Audiences: advocacy leaders and the public at large

100 patient advocates

12.000patient advocates

100.000individuals

EUPATI Educational Toolbox Educational tools for patient advocates Variety of distributable formats: Paper-based booklets,

presentations, eLearning, webinars, videos etc.

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

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

Within the next 5 years, the Patients‘ Academy will…

…and NOT:develop indication- or 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 indication- or therapy-specific

information!

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

Multi-StakeholderConsortium

10

European Patients Forum EUPATI Project Coordination◦ >50 umbrella patient organisations. Through

'members of members', potential outreachto 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.

Project led by 4 key pan-European patient associations

Additional partners in other patient organisations and "members of members"via "EUPATI Network"

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.

Ensuring Objectivity, Transparencyand Independence are vital

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

Uniqueness of the partnership

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/

Public license model guarantees fit-for-purpose re-use by the public

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.

EUPATI in 2016: What we will have achieved

Get to know us!

Web:www.patientsacademy.eu

Twitter: @eupatientsas well as: