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Jan Geissler – EUPATI Director
jan@patientsacademy.eu
Education of
patients (advocates) on R&D:
European Patients’ Academy
on Therapeutic Innovation
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.
Patients
should be at the center
of any health research.
But why and how?
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
 Need for post-marketing data
 Health Technology Assessment,
QoL, endpoints, comparators
 BUT long term pressure on health budgets
– here to stay
Window of
opportunity
 trial design
 relationship
between
researchers,
regulators,
industry,
patients
3
Patients – as key partners of researchers
More needs to be done: rare cancers will never be a priority unless
the patients make it one. Patients themselves must therefore
play a larger role in driving forward the search for therapies.
They are able to see connections that have eluded scientists.
“ „
Unique examples of patient involvement in
R&D and regulatory affairs already today
Patients' and Consumers' Working Party
Patient advocates’ key role in building
new environment for R&D
 Patient organisations have unique insights
into „real life“ and „real needs“ of patients:
• Gaps  research priorities
• Clinical trial design
• Quality of Life, Side effects
• Real-world access to therapies
• „Value“
• Patient-centered research policy
PatientPartner FP7 Project (2010),
www.patientpartner-europe.eu
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
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 policy
European Patients’ Academy: Paradigm shift
in empowering patients on medicines R&D
 Launched Feb ’12, runs for 5 years,
30 consortium members,
Funded by IMI JU
 will develop and disseminate
objective, credible,
correct and up-to-date public
knowledge about medicines
R&D
 will build competencies
& expert capacity among patients & public
 will facilitate patient involvement in R&D to collaborate in academic
research, industry research, authorities and ethics committees
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
Areas covered by the
European Patients’ Academy
1. Discovery of Medicines & Planning of Medicines 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. Health Technology Assessment and the
economics
…and NOT:
develop indication-
or therapy-specific
information!
EUPATI Internet Library
EUPATI Educational Toolbox
EUPATI Training Programme
To bring this to life, EUPATI develops
education targeted at different levels
100
“expert”
patient
advocates
12.000
patient
advocates
100.000
individuals
AT
BE
CH
DE
ES
FR
IT
IE
LU
MT
PL
UK
EUPATI Blended Learning
“Expert Patient” Training Course
 In-depth course for patient advocates to be able to contribute to
medicines R&D in academic groups, industry, competent authorities
(EMA & national), research policy etc.
 Course recruitment has opened on 6 March 2014,
closing date 20 April 2014, start of course Sept 2014
 Apply at www.patientsacademy.eu/apply
e-Learning
EUPATI Training Programme
9/2014 – 9/2015
Application
Phase
3-4/2014
e-Learning f2f e-Learning f2f
Certificate
Internet Library
Toolbox
Courses
Next steps
 EUPATI Public Workshop 2014
“Reaching a Public Audience on
Medicines Development”, 2 April 2014,
Warsaw
 Start of EUPATI Course
apply until 20 April 2014!
13
To address unmet needs
and make research more patient-centric,
(more) patient advocates need
to be involved as partners.
EUPATI helps
to make that happen.
Thank you!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as:

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Education of patients (advocates) on R&D: European Patients’ Academy EUPATI (Jan Geissler)

  • 1. Jan Geissler – EUPATI Director jan@patientsacademy.eu Education of patients (advocates) on R&D: European Patients’ Academy on Therapeutic Innovation 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.
  • 2. Patients should be at the center of any health research. But why and how?
  • 3. 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  Need for post-marketing data  Health Technology Assessment, QoL, endpoints, comparators  BUT long term pressure on health budgets – here to stay Window of opportunity  trial design  relationship between researchers, regulators, industry, patients 3
  • 4. Patients – as key partners of researchers More needs to be done: rare cancers will never be a priority unless the patients make it one. Patients themselves must therefore play a larger role in driving forward the search for therapies. They are able to see connections that have eluded scientists. “ „
  • 5. Unique examples of patient involvement in R&D and regulatory affairs already today Patients' and Consumers' Working Party
  • 6. Patient advocates’ key role in building new environment for R&D  Patient organisations have unique insights into „real life“ and „real needs“ of patients: • Gaps  research priorities • Clinical trial design • Quality of Life, Side effects • Real-world access to therapies • „Value“ • Patient-centered research policy PatientPartner FP7 Project (2010), www.patientpartner-europe.eu Research subject Info provider Advisor Reviewer Co-researcher Driving force
  • 7. 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 policy
  • 8. European Patients’ Academy: Paradigm shift in empowering patients on medicines R&D  Launched Feb ’12, runs for 5 years, 30 consortium members, Funded by IMI JU  will develop and disseminate objective, credible, correct and up-to-date public knowledge about medicines R&D  will build competencies & expert capacity among patients & public  will facilitate patient involvement in R&D to collaborate in academic research, industry research, authorities and ethics committees
  • 9. 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
  • 10. Areas covered by the European Patients’ Academy 1. Discovery of Medicines & Planning of Medicines 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. Health Technology Assessment and the economics …and NOT: develop indication- or therapy-specific information!
  • 11. EUPATI Internet Library EUPATI Educational Toolbox EUPATI Training Programme To bring this to life, EUPATI develops education targeted at different levels 100 “expert” patient advocates 12.000 patient advocates 100.000 individuals AT BE CH DE ES FR IT IE LU MT PL UK
  • 12. EUPATI Blended Learning “Expert Patient” Training Course  In-depth course for patient advocates to be able to contribute to medicines R&D in academic groups, industry, competent authorities (EMA & national), research policy etc.  Course recruitment has opened on 6 March 2014, closing date 20 April 2014, start of course Sept 2014  Apply at www.patientsacademy.eu/apply e-Learning EUPATI Training Programme 9/2014 – 9/2015 Application Phase 3-4/2014 e-Learning f2f e-Learning f2f Certificate Internet Library Toolbox Courses
  • 13. Next steps  EUPATI Public Workshop 2014 “Reaching a Public Audience on Medicines Development”, 2 April 2014, Warsaw  Start of EUPATI Course apply until 20 April 2014! 13
  • 14. To address unmet needs and make research more patient-centric, (more) patient advocates need to be involved as partners. EUPATI helps to make that happen.