A presentation delivered by IPPOSI CEO, Derick Mitchell at a conference organised by the Clinical Research Facility, St. James's Hospital, Dublin, May 2018

1. PATIENTS – SCIENCE – INDUSTRY
Irish Patient Education Programme - Pilot
Derick Mitchell, PhD

2. Outline of presentation
• Why educate patients?
• What format / content did we end up using?
• How did we fund / support it?
• How much did it cost – financial + in-kind?
• How inclusive / representative was it?
• What have we learned?

3. IPPOSI & The European Patients Academy
• EUPATI produces Expert Patients on
Medicines Research & Development
• Provides Training & Education
• Disseminates through national platforms
The project received 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.
www.eupati.eu

4. Practical “Roadmap” on patient involvement in medicines R&D
Research design
and Planning
Design of Protocol
Informed Consent Study reporting
Post-study
communication
Patient Info
Leaflet
Trial steering committee
Investigators Meeting
Level of expertise in the disease area required:
mediumhigh
Data Monitoring CommitteePractical
considerations
Health Technology
Assessment
Protocol
Synopsis
Research
priorities
Setting
research
priorities:
Information to
trial participants
Research conduct and
operations
Regulatory affairs
Dissemination,
communication,
post-approval
Source: Geissler, Ryll, Leto, Uhlenhopp (2017) Therapeutic Innovation & Regulatory Science. (doi: 10.1177/2168479017706405)
Fundraising
for research
Ethics Review

5. IPPOSI in EUPATI
• Provides the public-private
partnership model for EUPATI
• Establishes ‘IPPOSI-like’
EUPATI National Platforms
across Europe
ENP
PATIENTS,
advocates,
representatives,
organisations
ACADEMIA,
institutions, think
tanks, researchers
INDUSTRY,
pharmaceutical
companies
OTHER, regulators,
government, policy
shapers, healthcare
professionals,
journalists

6. The Impact of Patient Education
Role Before EUPATI After
Member of patient organisation, not actively involved 17% 2%
Active role in a patient organisation 62% 71%
Leadership role in a patient organisation 62% 71%
Employee of a patient organisation 25% 23%
Volunteer role in a patient organisation 60% 67%
Presenting at conferences, workshops etc. 63% 83%
Advising a pharmaceutical company 13% 44%
Advising a regulatory agency 21% 42%
Advising a reimbursement agency 4% 8%
EUPATI Fellows are increasingly taking leadership roles and are engaging with
pharma, regulators and HTA bodies. Role changes also imply identity shifts.

7. 13 EUPATI-trained Irish patients

8. Understanding Irish Context + Audience
• Irish patients are seeking education around medicines R&D.
• IPPOSI well placed to develop an irish-specific programme
• Depth of knowledge in Irish patient communities relatively low
• Experiences of Irish EUPATI trainees within EUPATI examined
• Proposed that pilot modules be designed for 20 participants

9. Pilot Irish Patient Education Programme
7 months – ended on March 12th, 2018
3 x 6-week Modules
• Understanding Clinical Trials
• Regulatory, Medicines Safety, PV
• HTA Principles + Practices
Irish Education Partners
2 Universities, 1 Regulator, 2 HTA Agencies
1 LMS website: www.patientsinvolved.ie
21 Students from 9 counties (36 applications)
6- member application review panel

10. Two Year Timeline
• April 2016 Early draft proposal discussed at IPPOSI board
• June 2016 Board Decision to pursue opportunity
• October 2016 Irish ENP meeting - feedback
• February 2017 Proposal disseminated to potential funders
• March 2017 Ed. Partners recruited + curriculum developed
• April 2017 Moodle Website created, EUPATI content upload
• April 2017 Irish ENP meeting – feedback on proposal
• May 2017 Launch of Application Process
• July-Aug 2017 21 Applicants Selected + Informed
• Sept 2017 Kick-off, First face-to-face workshop – Module 1
• Nov-Dec 2017 Module 2 – six weeks
• Jan-Mar 2018 Module 3 – seven weeks
• March 12th, 2018 Final workshop + Graduation of 20 students
• April 2018 Evaluation

11. Public Private Partnership Proposal

12. Funding Strategy
Potential Source Potential Avenue
Large pharmaceutical / CRO companies IPPOSI Industry Membership (20)
(Recognising the different procedures and
policies in each company)
Smaller biotech, genomics companies Broader industry network
Government departments / State
agencies / Research funders
Dept. of Health, Health Research Board,
Irish Research Council, HPRA (increasingly
interested in Patient and Public Involvement
(PPI))
Universities and Education providers Ten major Irish universities
Foundations and philanthropies Foundation partners, Google Foundation
Third Sector Patient organisations
IPPOSI receives and manage funds from donors

13. First Public Funding for PPI in Health Research
€1.75 million – 5 awards IPPOSI Partnering?
1. NUI Galway– Prof Sean Dinneen No
2. University College Dublin - Prof Thilo Kroll Yes
3. University of Limerick – Prof Anne MacFarlane Yes
4. Trinity College - Prof Mary McCarron Yes
5. Dublin City University - Dr Veronica Lambert No
(RCSI, UCC, ICGP still planning to partner in future)

14. eLearning Platform
LMS (Moodle site) – www.patientsinvolved.ie

15. Three 6-week Modules – different approaches
MoU WITH UNIVERISTY
CLINICAL RESEARCH CENTRE
• Created 40 purposely
designed online lectures,
modifying pre-existing course
material. (University IP)
• Significant support from CRC
administration + School of
Medicine IT dept.
• Certificate of completion with
UCD + IPPOSI logo
NATIONAL REGULATOR
• Not a recognized
Education Body.
• Engaged 10+ staff in pre-
existing EUPATI content
• Generated Irish-specific
content.
• 1 staff member
coordinated efforts
• Communications support
• Certificate of completion
with HPRA + IPPOSI logo
MoU WITH UNIVERSITY
DEPT. + HTA AGENCIES
• Engaged senior TCD +
NCPE + HIQA staff in
pre-existing EUPATI
content
• Generated Irish-
specific content
• Certificate of
completion with NCPE
+ IPPOSI + HIQA logo

16. Identifying interested parties
Role of Irish EUPATI
fellows!!
How did you hear about it?

17. Applications
• Total Applications: 36
• Applications Rejected
(i.e. after checking for completeness,
mandatory letter of motivation, etc.): 7
• Valid Applications: 29

18. Patient Organisations applying
• Alpha -1 Action Group
• Arthritis Ireland
• Irish Children's Arthritis Network
• Irish Cancer Society
• National Council for the Blind, Ireland
• Fighting Blindness (4)
• Vasculitis Ireland Awareness (3)
• Migraine Association of Ireland
• Spinal Injuries Ireland
• Irish Neonatal Health Alliance
• FibroIreland
• Tick Talk Ireland
• Cancer Trials Ireland PAAG
• ISGO PPI (Gynae Oncology)
• Patients for Patient Safety Ireland
• EASO Patient Council (Obesity)
• Sound Advice (Hearing)
• Order of Malta
• Chronic Pain Ireland

19. Selection Criteria & Procedure
Criteria applicants obliged to meet:
• Commitment to complete the programme
• Application of skills acquired to increase patient
representation, communication or facilitate
knowledge and education in others
• Basic experience/knowledge of medicines
research and development
• Working knowledge of English
• High-speed Internet connection
Criteria weighted by selection panel:
• Individual motivation
• Commitment to use and apply learning
• Experience related to the three module
areas for applying the acquired
knowledge/skills
• County of residence in the Republic of
Ireland
• Disease area

20. EUPATI-based scoring system
• MOTIVATION (30%)
• COMMITMENT TO APPLYING LEARNING (30%)
• SKILLS: (25%)
• Patient Representation - 8.3%
• Patient Communication - 8.3%
• Providing Education and Training - 8.3%
• PREVIOUS KNOWLEDGE / EXPERIENCE (15%)
• in medicines development process from preclinical research to approval (3%)
• in design and objectives of clinical trials and the roles of all stakeholders (3%)
• in drug safety and risk/benefit assessment of medicines (3%)
• in pharmacoeconomics, health economics and HTA(3%)
• of patients’ roles and responsibilities in medicines development (3%)

21. Kick-off: Friday, Sept. 22nd, 2017
MODULE IMPORTANT DATES
Module 1
Understanding
Clinical Trials
First Face-to-face workshop:
Friday, 22 September 2017
Online Content Release Dates:
Week 1 Material: Monday 25 September 2017
Week 2 Material: Monday 2 October 2017
Week 3 Material: Monday 9 October 2017
Week 4 Material: Monday 16 October 2017
Week 5 Material: Monday 23 October 2017
Second Face-to-Face workshop:
Friday, 3 November 2017
Deadline for completing the Module:
Friday, 10 November 2017

22. Face-to-Face Workshops
• Workshops typically half-day, scheduled in mid-part of
working day, to enable travel to/from on the day of
the event.
• Variable formats used depending on experience and
approach of education partner.
• Group-work very beneficial from student perspective.
• Used as vehicles to promote awareness of programme
via social media, websites etc.

23. Evaluation
• Student Experience
• 20 Question Online Survey on overall experience
• 9 Question Survey at the end of each module
• Education Partner Experience
• 10 Question Survey
• IPPOSI Experience
• Staff feedback

24. Overall trend in student feedback
• Expectations from students beforehand?
• Information, Knowledge, Understanding
• Uncertainty
• During? TIME COMMITMENT UNDERESTIMATED
• What students got out of it?
• Confidence
• Credibility - Certificate of completion
• Connections
• Insights

25. Student Feedback –
most valuable aspect?
The empowerment that the course provides cannot be
underestimated. At the end of the course I felt that my
knowledge of an area that I have worked in for many years has
been enriched and I would gladly have accepted even greater
detail in the course content.
Being introduced to the world of patient advocacy in
Ireland and EU and giving me a confidence that this
is an area that I can be a part of and make changes.
The commitment given by all those
preparing the material for the course
was much more than I could possibly
expect. I felt very privileged at the
attention to detail and need to make
sure we were getting the best from the
course and understanding all the
segments. HPRA input gives me the
confidence to understand the way the
system works in Ireland, I understand
their website and feel confident that I
can contribute information / use it in the
future.
The tutors that were made available. To have that quality of
expertise available to us was exceptional.

26. Impact

27. Meaningful Opportunities
RARE DISEASE
TECHNOLOGY AND
HIGHLY SPECIALISED
THERAPIES REVIEW
COMMITTEE
PUBLIC REVIEWING
OF PROPOSALS
EARLY SCIENTIFIC
ADVICE PILOT

28. IPPOSI Strategic Priority: Promote meaningful patient
involvement in Health Research and Policy
• Clinical Research Working group
• 28 members
• Repository active on IPPOSI website
• EUPATI Irish National Platform
• Identify opportunities
• PPI Ignite projects

29. MANY, MANY THANKS TO…
• IPPOSI
• IPPOSI Board members
• IPPOSI Staff
• Irish EUPATI Platform members
• Patient, Carer Communities
• IPPOSI patient members
• EUPATI Network
• EUPATI fellows
• Universities:
• UCD – Clinical Research Centre
• TCD – Dept. of Pharmacology & Therapeutics
• 6-member application review panel
• PPI Ignite projects (2) – public funding
• State Agencies:
• HPRA
• NCPE
• HIQA
• HRB supportive
• Industry:
• 5 IPPOSI member companies
• Abbvie
• GSK
• ICON
• Janssen
• Pfizer
- private funding

30. Next stage?
• Evaluation + Engagement with Partners + Funders
• Decision on future in June 2018
• Content Expansion
• New education partners + content
• Potential Future Modules on Rare Diseases, Research Ethics, Medical Devices,
Integrated Care
• Exploring mixed media options for existing content
• Webinars, live interactive lectures, gamification

31. Thank you!
@IPPOSI
www.ipposi.ie
dmitchell@ipposi.ie