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Nicola Bedlington, European Patients‘ Forum
Coordinator EUPATI
Patient involvement in
medicines R&D:
Here we are, and
where we want to be in 2020
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 transforming
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
2
Patients as partners of research:
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.
“ „
Patient advocates have a 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 measurement
• Real-world access to therapies
• „Value“
• Patient-centered research policy
Training essential to get expertise to contribute to
medicines research & development (R&D) Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
PatientPartner FP7 Project (2010),
www.patientpartner-europe.eu
Addressing public scrutiny and
distrust of research…
 Only 6-12% of cancer patients
participate 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
?
Patient advocates working with
regulators…
EMA track record since 2005…
 Patients‘ and Consumers‘ Working
Party (PCWP, 34 POs)
 Full members of MA Management
Board, COMP (rare diseases), PDCO
(pediatric), CAT (advanced therapies)
 Assessment of EPARs,
Package leaflets, safety information
 Ad-hoc support in CHMP:
Product assessment, guidelines,
Pharmacovigilance WG, protocol assistance
 Speakers and participants at
EMA conferences/workshops .....
 AND AT THE NATIONAL LEVEL
... Patient involvement ‚by accident‘
Having a patient (advocate) in every
Research Ethics Committee…
• 9.400 EU applications for
clinical studies/year
• 5.000 clinical studies initiated
in EU/year
– 25% multinational
= ~1250 studies/year
– 4.5 Member States on
average per
multinational study
– Single opinion per
country assumed
– For 1250 multinational
studies, more than 5.000
ethics panels with
35.000 panelists needed
Sources: Impact on Clinical Research of European Legislation (ICREL),
Final Report, Feb. 2009, and Rokus de Zeeuw 2010
Having a patient‘s voice in
pharmaceutical policy at both European
and national level
EPF survey on HTA agencies,
decision makers and patients
• Patient involvement in HTA has the most impact in putting
forward patients’ needs in terms of QoL and providing a
real-life context to the use of health technologies; this is
acknowledged by all
• To facilitate patient involvement, HTA agencies and
decision-makers provide access to
• HTA reports/guides/protocols,
• easy-to-read HTA summaries
• – but no training support for patients
Patients want a seat at the table.
Currently, there are many empty seats.
This is why we have
established the
European Patients‘ Academy (EUPATI).
EUPATI: A paradigm shift in empowering
patients on medicines R&D
 Launched Feb ’12, runs for 5 years,
30 consortium members,
PPP of EU Commission and EFPIA
 will develop and disseminate
objective, credible, correct 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
 EUPATI platform complete with training courses,
education, information material in multiple
languages
 Good practice guidelines on patient involvement
available and in use
 Public conferences and regional workshops will
lead to an extensive expert network established.
 12 National Platforms established in 12 countries
 Robust strategy on sustainability and political
buy-in
EUPATI by 2017:
Where we want to be.
EUPATI can make the difference.
creating the tipping point for patient
engagement in medicines R&D
It‘s for all of us to make it happen.
Get to know us!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as:

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EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here we are, and where we want to be in 2020

  • 1. Nicola Bedlington, European Patients‘ Forum Coordinator EUPATI Patient involvement in medicines R&D: Here we are, and where we want to be in 2020 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. Medical landscape is transforming 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 2
  • 3. Patients as partners of research: 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. “ „
  • 4. Patient advocates have a 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 measurement • Real-world access to therapies • „Value“ • Patient-centered research policy Training essential to get expertise to contribute to medicines research & development (R&D) Research subject Info provider Advisor Reviewer Co-researcher Driving force PatientPartner FP7 Project (2010), www.patientpartner-europe.eu
  • 5. Addressing public scrutiny and distrust of research…  Only 6-12% of cancer patients participate 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 ?
  • 6. Patient advocates working with regulators… EMA track record since 2005…  Patients‘ and Consumers‘ Working Party (PCWP, 34 POs)  Full members of MA Management Board, COMP (rare diseases), PDCO (pediatric), CAT (advanced therapies)  Assessment of EPARs, Package leaflets, safety information  Ad-hoc support in CHMP: Product assessment, guidelines, Pharmacovigilance WG, protocol assistance  Speakers and participants at EMA conferences/workshops .....  AND AT THE NATIONAL LEVEL ... Patient involvement ‚by accident‘
  • 7. Having a patient (advocate) in every Research Ethics Committee… • 9.400 EU applications for clinical studies/year • 5.000 clinical studies initiated in EU/year – 25% multinational = ~1250 studies/year – 4.5 Member States on average per multinational study – Single opinion per country assumed – For 1250 multinational studies, more than 5.000 ethics panels with 35.000 panelists needed Sources: Impact on Clinical Research of European Legislation (ICREL), Final Report, Feb. 2009, and Rokus de Zeeuw 2010
  • 8. Having a patient‘s voice in pharmaceutical policy at both European and national level
  • 9. EPF survey on HTA agencies, decision makers and patients • Patient involvement in HTA has the most impact in putting forward patients’ needs in terms of QoL and providing a real-life context to the use of health technologies; this is acknowledged by all • To facilitate patient involvement, HTA agencies and decision-makers provide access to • HTA reports/guides/protocols, • easy-to-read HTA summaries • – but no training support for patients
  • 10. Patients want a seat at the table. Currently, there are many empty seats. This is why we have established the European Patients‘ Academy (EUPATI).
  • 11. EUPATI: A paradigm shift in empowering patients on medicines R&D  Launched Feb ’12, runs for 5 years, 30 consortium members, PPP of EU Commission and EFPIA  will develop and disseminate objective, credible, correct 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
  • 12.  EUPATI platform complete with training courses, education, information material in multiple languages  Good practice guidelines on patient involvement available and in use  Public conferences and regional workshops will lead to an extensive expert network established.  12 National Platforms established in 12 countries  Robust strategy on sustainability and political buy-in EUPATI by 2017: Where we want to be.
  • 13. EUPATI can make the difference. creating the tipping point for patient engagement in medicines R&D It‘s for all of us to make it happen.
  • 14. Get to know us! Web: www.patientsacademy.eu Twitter: @eupatients as well as: