EUPATI
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n...
In summary
Who are IPPOSI?
EUPATI Ireland
Why get involved in EUPATI?
What is EUPATI all about!
PATIENT’S LEADING THE
DISCUSSION
Eibhlín Mulroe, MBA
CEO, IPPOSI
IPPOSI Strategy 2012-2014
4
Our Mission
We expedite
development
of and patient
access to
innovative
therapies
through a
un...
Leadership
IPPOSI Topics 2013
 Access to innovative treatments
- Clinical Research
- HTA
 Rare Diseases and the Cross Border Direct...
Secretary General, Department of Health
Annual IPPOSI Roundtable Meeting
IPPOSI –patient voice at the table
Rare Diseases
National Plan for Rare Diseases
•Launch in May 2014
•DOH officials
•Drawing from Consultation
IPPOSI - patient voice at the table
Health Technology
Assessment
HTA
 Involving the patient…
 IPPOSI and HTA Agency
Developing a process
HTAi
 Patient involvement in HTA: What added value?
 K.M. Facey Health Economics and HTA, Institute of Health and Wellbe...
EPF survey on HTA agencies,
decision makers and patients
• Patient involvement in HTA has the most impact in putting
forwa...
IPPOSI - patient voice at the table
Clinical Research
CLINICAL RESEARCH
in Ireland
“Without a thriving clinical research
culture in Ireland, Irish patients with
severe unmet me...
REPORT INTO THE GENERAL PUBLIC’S ATTITUDES
TOWARDS CLINICAL RESEARCH
Prepared for IPPOSI
by
Drury Research
November 2009
Agree v Disagree with Attitudinal
Statements RANKING 1 - 5
26 12 20 12 29 1
50 15 16 5 14
56 14 11 4 14 1
60 17 14 3 5 2
I...
2014 EXPANDING OUR CLINICAL TRIALS INFORMATION
CAMPAIGN
EUPATI Ireland
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agr...
EUPATI Ireland
National Liason Team
The project is receiving support from the Innovative Medicines Initiative Joint Undert...
EUPATI Ireland
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agr...
EUPATI
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n...
Medical landscape is transforming
at a fast pace
Innovation transforms the lives of
patients with serious, lifelong condit...
Patients as partners of research:
More needs to be done!
Rare cancers will never be a priority unless the patients make it...
Patient advocates have a key role in
building new environment for R&D
 Patient organisations have unique insights into
„r...
Addressing public scrutiny and
distrust of research…
 Only 6-12% of cancer patients
participate in clinical studies
 75%...
Patient advocates working with
regulators…
EMA track record since 2005…
Patients‘ and Consumers‘ Working
Party (PCWP, 34 ...
Having a patient (advocate) in every
Research Ethics Committee…
• 9.400 EU applications for
clinical studies/year
• 5.000 ...
Patient advocates through
IPPOSI in Ireland working with…
 Irish Medicines Board
 Health Information and Quality Authori...
Patients want a seat at the table.
Currently, there are many empty seats.
This is why we have
established the
European Pat...
http://www.patientsacademy.eu – info@patientsacademy.eu
European Patients’ Academy
on Therapeutic Innovation
The project i...
Key stakeholders of the
Patients’ Academy
Audiences: advocacy leaders
and the public at large
EUPATI Certificate Training Programme
Academic Modular Certificate Pr...
Topics of EUPATI Training Courses
(which will also be covered in web library – more info
later today)
Topic areas:
nDiscov...
Patients' Academy: up, running and real. Workshop,
5 Sept 2012 and National Liaisons Workshop in March
2013. Warsaw next i...
AT
BE
CH
DE
ES
FR
IT
IE
LUX
MT
PL
UK
National EUPATI “National Liaison
Teams” and “National Platforms”
 Initiated by “tri...
EUPATI: A paradigm shift in empowering
patients on medicines R&D
 Launched Feb ’12, runs for 5 years,
30 consortium membe...
 EUPATI platform complete with training courses,
education, information material in multiple
languages
 Good practice gu...
EUPATI can make the difference.
creating the tipping point for patient
engagement in medicines R&D
It‘s for all of us to m...
EUPATI NATIONAL LIAISON TEAM UK
GET INVOLVED!
Irene Oldfather, Life Changes Trust Programme Director, Health and
Social Ca...
Get to know us!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as:
For further information: emulroe@ipposi.ie
Sign up for newsletter info@ipposi.ie
Twitter @EibhlinMulroe
@ipposi
More Infor...
EUPATI – EU: An overview (Eibhlin Mulroe, EUPATI / IPPOSI)
EUPATI – EU: An overview (Eibhlin Mulroe, EUPATI / IPPOSI)
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EUPATI – EU: An overview (Eibhlin Mulroe, EUPATI / IPPOSI)

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"EUPATI – EU: An overview", held by Eibhlin Mulroe (EUPATI / IPPOSI) at the EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK

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  • EUPATI – EU: An overview (Eibhlin Mulroe, EUPATI / IPPOSI)

    1. 1. EUPATI 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. An overview
    2. 2. In summary Who are IPPOSI? EUPATI Ireland Why get involved in EUPATI? What is EUPATI all about!
    3. 3. PATIENT’S LEADING THE DISCUSSION Eibhlín Mulroe, MBA CEO, IPPOSI
    4. 4. IPPOSI Strategy 2012-2014 4 Our Mission We expedite development of and patient access to innovative therapies through a unique partnership of Patient Groups, Industry and Science Vision Patients in Ireland have prompt access to new and developing innovative therapies To deliver on our Vision Our Strategic Priorities • Bring a patient perspective to clinical research in Ireland • Actively influence policy that impacts on research and access to innovative therapies • Increase understanding of the work done by IPPOSI • Source funding to ensure IPPOSI’s sustainability
    5. 5. Leadership
    6. 6. IPPOSI Topics 2013  Access to innovative treatments - Clinical Research - HTA  Rare Diseases and the Cross Border Directive  Patient Compliance Patient-Led Partnership Consensus Building between Stakeholders Inform
    7. 7. Secretary General, Department of Health Annual IPPOSI Roundtable Meeting
    8. 8. IPPOSI –patient voice at the table Rare Diseases
    9. 9. National Plan for Rare Diseases •Launch in May 2014 •DOH officials •Drawing from Consultation
    10. 10. IPPOSI - patient voice at the table Health Technology Assessment
    11. 11. HTA  Involving the patient…  IPPOSI and HTA Agency Developing a process
    12. 12. HTAi  Patient involvement in HTA: What added value?  K.M. Facey Health Economics and HTA, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK “there is a need to move from emotive views to finding a way that allows robust elicitation patients’ perspectives. As happens in the other parts of HTA, a systematic method is needed, using an explicit analytical approach, and findings need to scrutinized.”
    13. 13. 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 Patient organisations need more capacity to engage on HTA
    14. 14. IPPOSI - patient voice at the table Clinical Research
    15. 15. CLINICAL RESEARCH in Ireland “Without a thriving clinical research culture in Ireland, Irish patients with severe unmet medical needs will be deprived of life-saving treatments.” Report from IPPOSI National Strategic Forum for Clinical Research Farmleigh, Dublin, 27 November 2009
    16. 16. REPORT INTO THE GENERAL PUBLIC’S ATTITUDES TOWARDS CLINICAL RESEARCH Prepared for IPPOSI by Drury Research November 2009
    17. 17. Agree v Disagree with Attitudinal Statements RANKING 1 - 5 26 12 20 12 29 1 50 15 16 5 14 56 14 11 4 14 1 60 17 14 3 5 2 I w ould only participate in clinical trials if I w as very sick I w ould be w illing to supply personal medical information for medical research if it is done in a confidential manner I w ould be w illing to donate blood to be used for clinical research I think carrying out clinical research in I reland w ith the aim of developing new w ays to treat many diseases is a good idea Strongly agree Agree Neither/nor Disagree Disagree strongly DK {Base: n=1000, All adults}
    18. 18. 2014 EXPANDING OUR CLINICAL TRIALS INFORMATION CAMPAIGN
    19. 19. EUPATI Ireland 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. NLT
    20. 20. EUPATI Ireland National Liason Team 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. Mr. Peter Kelly, Irish Chronic Pain Association Ms Siobhan Gaynor, Molecular Medicine Ireland and ICRIN Ms Sinead Duffy, Bayer Healthcare
    21. 21. EUPATI Ireland 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. HTA Training Day with National Agency and Patients January 2014 OUTCOMEREPORTAVAILABLEON ipposi.ie Katie Murphy @KatieMurphy1989 Jan 24 @EibhlinMulroe @ipposi thanks for organising a great,informative session! Looking forward to forming some action points & moving forward � Dmitri Wall @DmitriWall Jan 24 At another great @IPPOSI conference where the NCPE are discussing health technology assessment
    22. 22. EUPATI 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. The backdrop to the setting up of EUPATI
    23. 23. 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 24
    24. 24. 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. “ „
    25. 25. 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 ReviewerReviewer Co-researcherCo-researcher Driving forceDriving force PatientPartner FP7 Project (2010), www.patientpartner-europe.eu With more than 200 cancers and >6000 rare diseases, we need many qualified patient experts!
    26. 26. 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 ? Europe has a lot of safeguards in medicines R&D – but public image lagging behind
    27. 27. 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‘ Patient organisations need more qualified advocates to engage with regulators
    28. 28. 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 If patients are to be involved in RECs on a broad level, we need more patients who understand how trials work
    29. 29. Patient advocates through IPPOSI in Ireland working with…  Irish Medicines Board  Health Information and Quality Authority  Department of Health Steering Group on Rare Diseases  Health Service Executive Patient Forum  National Centre for Pharmacoeconomics (HTA) Patient organisations needmore qualified advocates toengage with regulators
    30. 30. Patients want a seat at the table. Currently, there are many empty seats. This is why we have established the European Patients‘ Academy (EUPATI).
    31. 31. http://www.patientsacademy.eu – info@patientsacademy.eu 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.
    32. 32. Key stakeholders of the Patients’ Academy
    33. 33. Audiences: advocacy leaders and the public at large 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 100 patient advocates 12.000 patient advocates 100.000 individuals 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
    34. 34. Topics of EUPATI Training Courses (which will also be covered in web library – more info later today) Topic areas: nDiscovery of Medicines & Planning of Medicine Development nNon-Clinical Testing and Pharmaceutical Development nExploratory and Confirmatory Clinical Development nClinical Trials nRegulatory Affairs, Medicinal Product Safety, Pharmacovigilance and Pharmaco-epidemiology nHTA principles and practices +Patients‘rolesand responsibilities 35 …and NOT: develop indication- or therapy-specific information!
    35. 35. Patients' Academy: up, running and real. Workshop, 5 Sept 2012 and National Liaisons Workshop in March 2013. Warsaw next in April, 2014! Patients' Academy: up, running and real. Workshop, 5 Sept 2012 and National Liaisons Workshop in March 2013. Warsaw next in April, 2014!  100 participants from 24 countries  Majority patient advocates  12 countries building national platforms  100 participants from 24 countries  Majority patient advocates  12 countries building national platforms 36
    36. 36. AT BE CH DE ES FR IT IE LUX MT PL UK National EUPATI “National Liaison Teams” and “National Platforms”  Initiated by “trio” of patient orgs, academia, industry  Patient LEAD and • make sure EUPATI understands educational needs in R&D on national level • disseminate EUPATI’s existing training material and information on the national level • raise public awareness & interest about EUPATI • identify training faculty, logistics and financial support on the national level Budget of 9k available to all 12 NLTs to begin work.
    37. 37. 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
    38. 38.  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.
    39. 39. 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.
    40. 40. EUPATI NATIONAL LIAISON TEAM UK GET INVOLVED! Irene Oldfather, Life Changes Trust Programme Director, Health and Social Care Alliance Scotland www.alliance-scotland.org.uk Dr Sue Pavitt, Reader in Applied Health Research, Leeds Institute of Health Sciences, University of Leeds http://www.leeds.ac.uk/lihs/ Bella Starling PhD, Director of Public Programmes, Nowgen, Manchester Academic Health Sciences Centre. www.nowgen.org.uk Kay Warner, Project Manager, GlaxoSmithKline http://www.gsk.com/
    41. 41. Get to know us! Web: www.patientsacademy.eu Twitter: @eupatients as well as:
    42. 42. For further information: emulroe@ipposi.ie Sign up for newsletter info@ipposi.ie Twitter @EibhlinMulroe @ipposi More Information

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