"European Patients’ Academy on Therapeutic Innovation: Shifting paradigms in empowering patients on medical R&D": Presentation by Jan Geissler (Twitter @jangeissler) at the Belgian Association of Clinical Research Professionals (ACRP.be) meeting on 25 Oct 2012

1. European Patients’ Academy on Therapeutic Innovation:
Shifting paradigms in empowering
patients on medical R&D
Belgian Association of Clinical Research Professionals Meeting, 25 Oct 2012
Jan Geissler
EUPATI Director

2. Unmet needs: There is no
„magic bullet“ for most patients
 “Success stories” available only to
small numbers of rare cancers, rare
diseases, patients at “best age”
 Patients need innovation!
5-year survival in cancer (USA, 2008)
National Cancer Institute (2008) Source: RareCare (2012)

3. Patients have unmet needs --
window of opportunity in R&D
New opportunities:
 Molecular targets/pathways Window of
 Genome sequencing opportunity
 Translational research  new
 “Personalized” medicine relationship
between
 Companion diagnostics
researchers,
 Need for post-marketing data regulators,
 HTA, QoL, endpoints, comparators industry,
 Healthcare budgets, drug pricing patients

4. Overcoming public scrutiny
on research
 Lack of public confidence in
research leads to
• lack of trial recruitment
(6-12% of cancer patients take part in research)
• delayed generation of meaningful
clinical data
• slow progress or lack of research
• bad image of research in population
 Objective information to the public
& more transparency needed

5. Patient advocates’ key role in
building new environment for R&D
 Patient organisations have unique insights
in „real life“ and „real needs“ of patients:
• Gap analysis in research priorities
• Clinical trial design
• Priority setting in healthcare budgets
Driving force
• Research policy
Co-researcher
Reviewer
 Training required to get expertise Advisor
required to contribute to scientific projects
Info provider
Research subject
PatientPartner FP7 Project (2010),
www.patientpartner-europe.eu

6. Unmet need of patient & public,
and great willingness to contribute!
 Patients…
• seek up-to-date, credible, understandable information
about innovation in treatments
• are largely unaware about clinical trials, translational
research, personalized medicine, health economics,
their 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

7. EUPATI: A paradigm shift in
involving patients in medicines R&D
 Great individual initiatives to train patient
advocates - by patient organisations,
academia, industry, healthcare
professionals
 Complemented by:
The European Patients’ Academy
on Therapeutic Innovation

8. EUPATI: Paradigm shift in
empowering patients on med R&D
 Launched Feb ’12, runs for 5 years,
29 consortium members,
PPP of EU Commission and EFPIA
 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 support
industry, academia, authorities and ethics committees

9. EUPATI Audiences: advocacy
leaders and the lay public
100
EUPATI Certificate patient
Training Programme advocates
English
French
12.000 German
EUPATI Educational patient Spanish
Toolbox advocates Polish
Italian
Russian
EUPATI 100.000
Internet Library individuals

10. Areas covered by EUPATI
1. Medicines development process
from research to approval
2. Personalized, predictive medicine
3. Drug safety, risk/benefit assessment of medicines
4. Pharmaco-economics, health economics
and health technology assessment
5. Design & objectives of clinical trials
(& roles of stakeholders)
…and NOT:
6. Patients roles & responsibilities in develop indication-
medicines development or therapy-specific
information!

11. Multi-stakeholder consortium,
transparently governed
 Led by European Patients’ Forum &
pan-EU patient organisations
 Strong impetus from key academic
partners and non-profit organisations
 Industry expertise in medicines R&D
 Advisory bodies help ensuring
independence, transparency, good
governance
• EMA, Swissmedic, MHRA, BfArM
• Key experts in bioethics, genetics, HTA,
economics, evidence based med,
patient advocacy
• Ethics Panel

12. EUPATI in 2016:
What EUPATI 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.

13. Get to know us!
Jan Geissler
EUPATI Director
jan@patientsacademy.eu
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as: