Nicola Bedlington, European Patients‘ ForumCoordinator EUPATIPatient involvement inmedicines R&D:Here we are, andwhere we ...
Medical landscape is transformingat a fast paceInnovation transforms the lives ofpatients with serious, lifelong condition...
Patients as partners of research:More needs to be done!Rare cancers will never be a priority unless the patients make iton...
Patient advocates have a key role inbuilding new environment for R&D Patient organisations have unique insights into„real...
Addressing public scrutiny anddistrust of research… Only 6-12% of cancer patientsparticipate in clinical studies 75% of ...
Patient advocates working withregulators…EMA track record since 2005… Patients‘ and Consumers‘ WorkingParty (PCWP, 34 POs...
Having a patient (advocate) in everyResearch Ethics Committee…• 9.400 EU applications forclinical studies/year• 5.000 clin...
Having a patient‘s voice inpharmaceutical policy at both Europeanand national level
EPF survey on HTA agencies,decision makers and patients• Patient involvement in HTA has the most impact in puttingforward ...
Patients want a seat at the table.Currently, there are many empty seats.This is why we haveestablished theEuropean Patient...
EUPATI: A paradigm shift in empoweringpatients on medicines R&D Launched Feb ’12, runs for 5 years,30 consortium members,...
 EUPATI platform complete with training courses,education, information material in multiplelanguages Good practice guide...
EUPATI can make the difference.creating the tipping point for patientengagement in medicines R&DIt‘s for all of us to make...
Get to know us!Web:www.patientsacademy.euTwitter: @eupatientsas well as:
Upcoming SlideShare
Loading in...5
×

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

771

Published on

"Patient involvement in medicines R&D: Here we are, and where we want to be in 2020" by Nicola Bedlington, Executive Director of European Patients' Forum and Coordinator of the EUPATI project, at the EUPATI 2013 Conference on 19 April 2013.

Published in: Health & Medicine, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
771
On Slideshare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

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

  1. 1. Nicola Bedlington, European Patients‘ ForumCoordinator EUPATIPatient involvement inmedicines R&D:Here we are, andwhere we want to be in 2020The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composedof financial contribution from the European Unions Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
  2. 2. Medical landscape is transformingat a fast paceInnovation transforms the lives ofpatients 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 healthbudgets – here to stayWindow ofopportunity trial design relationshipbetweenresearchers,regulators,industry,patients2
  3. 3. Patients as partners of research:More needs to be done!Rare cancers will never be a priority unless the patients make itone. Patients themselves must therefore play a larger role indriving forward the search for therapies. They are able to seeconnections that have eluded scientists.“ „
  4. 4. Patient advocates have a key role inbuilding 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 policyTraining essential to get expertise to contribute tomedicines research & development (R&D) Research subjectInfo providerAdvisorReviewerCo-researcherDriving forcePatientPartner FP7 Project (2010),www.patientpartner-europe.eu
  5. 5. Addressing public scrutiny anddistrust of research… Only 6-12% of cancer patientsparticipate in clinical studies 75% of Phase II-IV studies delayed due toslow patient recruitment Bad image one reason fordelayed generation ofmeaningful clinical data?
  6. 6. Patient advocates working withregulators…EMA track record since 2005… Patients‘ and Consumers‘ WorkingParty (PCWP, 34 POs) Full members of MA ManagementBoard, 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 atEMA conferences/workshops ..... AND AT THE NATIONAL LEVEL... Patient involvement ‚by accident‘
  7. 7. Having a patient (advocate) in everyResearch Ethics Committee…• 9.400 EU applications forclinical studies/year• 5.000 clinical studies initiatedin EU/year– 25% multinational= ~1250 studies/year– 4.5 Member States onaverage permultinational study– Single opinion percountry assumed– For 1250 multinationalstudies, more than 5.000ethics panels with35.000 panelists neededSources: Impact on Clinical Research of European Legislation (ICREL),Final Report, Feb. 2009, and Rokus de Zeeuw 2010
  8. 8. Having a patient‘s voice inpharmaceutical policy at both Europeanand national level
  9. 9. EPF survey on HTA agencies,decision makers and patients• Patient involvement in HTA has the most impact in puttingforward patients’ needs in terms of QoL and providing areal-life context to the use of health technologies; this isacknowledged by all• To facilitate patient involvement, HTA agencies anddecision-makers provide access to• HTA reports/guides/protocols,• easy-to-read HTA summaries• – but no training support for patients
  10. 10. Patients want a seat at the table.Currently, there are many empty seats.This is why we haveestablished theEuropean Patients‘ Academy (EUPATI).
  11. 11. EUPATI: A paradigm shift in empoweringpatients on medicines R&D Launched Feb ’12, runs for 5 years,30 consortium members,PPP of EU Commission and EFPIA will develop and disseminateobjective, credible, correct knowledgeabout medicines R&D will build competencies& expert capacity among patients& public will facilitate patient involvement in R&Dto support industry, academia, authoritiesand ethics committees
  12. 12.  EUPATI platform complete with training courses,education, information material in multiplelanguages Good practice guidelines on patient involvementavailable and in use Public conferences and regional workshops willlead to an extensive expert network established. 12 National Platforms established in 12 countries Robust strategy on sustainability and politicalbuy-inEUPATI by 2017:Where we want to be.
  13. 13. EUPATI can make the difference.creating the tipping point for patientengagement in medicines R&DIt‘s for all of us to make it happen.
  14. 14. Get to know us!Web:www.patientsacademy.euTwitter: @eupatientsas well as:

×