Delivered by Dr Ruth Barrington, Director, Molecular Medicine Ireland at the IPHA Annual Meeting 2010.

1. The Role of Clinical Research in securing the
Future of the Industry in Ireland –
A Molecular Medicine Ireland perspective
Ruth Barrington
Chief Executive
Molecular Medicine Ireland
1

2. Molecular Medicine Ireland (MMI)
Vision - improved healthcare through the
development of diagnostics and therapies from
concept to realisation
The mission of MMI is to mobilise the
strengths of the five partner
institutions and their associated
hospitals to build a sustainable
national system to coordinate,
support and promote translational
and clinical research

3. MMI Board – Academic/Industry Partnership
Dr Damian O’Connell, Pfizer,
Chair
Dr Will Deare, AmGen
Ms Helen Ryan, Creganna
Dr Marina Zvartau-Hind, GSK
Dr John Climax, ICON
Mr Dave Shanahan, IDA
Prof Larry Egan NUIG
Secretary – John Coman, UCD
Prof Bill Powderly, UCD
Prof Des Fitzgerald, UCD
Prof Dermot Kelleher, TCD
Prof David Lloyd, TCD
Prof Gerry McElvaney, RCSI
Prof Hannah McGee, RCSI
Prof Tim O’Brien, NUIG
Prof Jonathan Hourihane ,
UCC

4. Why Pharma is important to Ireland
• Life science sector exports – €40bn+
• 44,000 employed
• 8/10 top pharma companies
• Making people healthier
– Public expenditure on
pharmaceuticals = €2bn pa
– 70m prescribed drugs –GMS/CDS pa

5. Clinical Research – Why we need it
• to improve the quality of care for patients
and the population,
• to enhance the reputation of clinical
research in Ireland
• to facilitate innovation by indigenous
companies
• to attract R&D investment by
international pharma and medical device
companies.

6. Clinical Research – why we need it
• Clinical trials are a necessary step
in demonstrating the safety and
effectiveness of new medicines,
vaccines and devices or new
applications for established
products before they are used in the
clinical care of patients

7. Clinical Trials – Economic return
• Clinical trials create employment
– in the conduct of trials,
– in the companies that use trials to test their
products and
– through the foreign direct investment
attracted by clinical trial capacity

8. Clinical Trials – Economic Benefit
• The economic benefit in the US
from eight clinical trials exceeded
$15 bn over 10 years
US National Institute of Neurological Disorders
and Strokes

9. Clinical Research – Economic Return
• Wellcome Trust et al found that a £1
investment of public or charitable funds
in cardiovascular disease research
yielded a stream of benefits to the UK
thereafter equivalent in value to earning
£0.39 per year in perpetuity.
• Equivalent rate of return for investment
in mental health research was £0.37 for
every £1 invested in perpetuity.

10. Clinical Trials Capacity – a national priority?
• Ireland ‘a leading country for the
timing, access and relevance of
clinical trials’.
Renewed Programme for Government

11. Clinical Trials Capacity – a national priority?
• ‘the development of a clinical trials
research system is critical for the future
growth and development of (the life
science sector) in Ireland (both
indigenous and MNCs) and to ensure
that we leverage investments in research
and development - translating from
bench to bedside’.
Report of the Innovation Taskforce

12. Clinical Trials Capacity – a national priority?
• Building clinical research capacity
at the core of
– the Health Research Action Plan
(DOHC/DETI)
– HRB Business Strategy

13. Contribution to National Recovery
• ‘Productive, high quality research, undertaken
by highly skilled research teams working closely
with industry partners will continue to be a core
investment priority for Government.’
• ‘Government will deliver the Health Information
Bill which will speed up ethical review of health
research trials and investigations.’
• ‘Government will invest in R&D industry/third
level sector collaboration.’
The National Recovery Plan 2011-14

14. Clinical Trial Activity in Ireland
Applications of IMP Clinical Trials reviewed
by the IMB
0
50
100
150
200
2002 2003 2004 2005 2006 2007 2008 2009

15. IMP STUDIES APPROVED BY IMB
2009
20 18
46
13
97
0
20
40
60
80
100
120
PHASE 1 PHASE 2 PHASE 3 PHASE 4 TOTAL

16. NUMBER OF APPLICATIONS & ON-GOING CTS IN NORDIC
COUNTRIES & IRELAND
Ref: Stinta Gestrelius, Nordic Co-operation in Clinical Research - Opportunities and Challenges (18 February
2009 & updated 30 March 2009)
APPLICATIONS PER YEAR
DENMARK 300
FINLAND n/a
NORWAY n/a
SWEDEN 400 (2008)
IRELAND 97 (2009)
ON-GOING
390
742
281
426
514

17. MARKETING AUTHORISATION APPLICATIONS
FOR CLINICAL TRIALS
EMA 2009
CTS Sites Patients
AUSTRIA 93 262 3,668
DENMARK 79 382 8,814
FINLAND 89 397 12,194
IRELAND 29 87 397
NORWAY 64 285 5,599
SWEDEN 110 572 8,417
PORTUGAL 60 210 1,376

18. COMMERICAL & NON-COMMERCIAL CTS APPLICATIONS
IRELAND
DENMARK
90 10
70 30
NON-COMMERICAL
%
COMMERICAL
%

19. Key Metrics for Commercial Clinical
Trials – Core Countries
• Start up speed – median number of days
from receipt of protocol package to letter of
regulatory approval/ethics approval.
• Cycle time – median number of days from
regulatory approval to last patient’s first visit.
• Recruitment reliability – number of actual
patients randomised as percentage of number
planned per study.

20. Ireland not core for industry CTs
• From an industry perspective, clinical
research in Ireland is
– fragmented,
– unpredictable,
– overly dependent on personal connections,
– has too many problems with regulatory
compliance,
– is expensive vis a vis the size of the market
– is not conducted in a coordinated manner.

21. So what is being done to build
capacity?
• MMI mission
• Irish Clinical Research
Infrastructure Network – ICRIN
• HRB/Wellcome Trust Dublin Centre
for Clinical Research
• ICORG, RCSI – CIST, C-STAR
• Academic Health Centres

22. ICRIN Vision
Ireland is a country of choice for
scientifically relevant multi-centre
clinical studies and trials in specialist
fields where partners are strong.

23. Irish Clinical Research Infrastructure
Network - ICRIN
• HRB and HSE funded
• Coordinating facilities, expertise and processes
to create a national system for clinical research
– Research readiness, SOPs, ethics, IRNN
• Building capacity for clinical research
– GCP, indemnity, sponsorship, Roadmap, EI Clinical
Trials Liaison Services, therapeutic groups
• Integrating Irish network with the European
Clinical Research Infrastructure Network
(ECRIN)

24. ICRIN Working Group
Composition
• Professor Larry Egan, NUI Galway, Chair
• Marie Mellody, ICRIN Coordinator
• CRC directors and investigators
• Clinical research personnel
Terms of Reference
• to facilitate scientifically relevant investigator
and industry led multi-centre clinical trials in the
ICRIN network

25. What will the ICRIN network offer?
• CRCs in Dublin, Cork and Galway networked together
operating to agreed standards to recruit patients to multi-
centre studies
– Acting as hubs for research activities in their hospitals
– Each a gateway to network expertise & resources
– Working to agreed list of research services & costs
– Lead CRC coordinating ethical, regulatory & site
specific approval, indemnity/sponsorship within
agreed time limit
– Supporting a web portal that offers up to date
information on network services and expertise
– Working with therapeutic groups to conduct multi-
centre and multi-national studies

26. Dublin Centre for Clinical Research
• Clinical Research collaboration between MMI, RCSI,
TCD and UCD
• Major Investment in clinical research infrastructure
for Dublin:
– New Clinical Research Facility for TCD in the heart of St.
James’s Hospital
– A network to conduct multi-centre studies and clinical trials
– Enlargement and up-skilling of Research Nurse resources
– IT infrastructure that supports multi-centred clinical research
– Formation of Therapeutic and Clinical Interest Groups

27. Dublin Centre for Clinical Research -
Achievements
• Therapeutic/Clinical Interest groups supported
Diabetes, Respiratory, GI, Inflammatory Skin Disease,
Neuropsychiatry, Michael Gill, Prostate Cancer,HIV/TB,
Neurodegeneration, Ophthalmology
• Studies completed/underway – 10 at 6 hospitals
• Patients recruited – 2,185 patients recruited
• Nurse education – RCSI Cert.in Clinical Research Nursing
• Clinical informatics/ Study management – in place
• Standard form for ethical approval of non-IMP studies
• Clinical Trial – first CT has IMB and ethical approval

28. What’s missing?
The Integrated Landscape
• HSE support for clinical research as a core
function of the health service
• Financial support for therapeutic groups linked
to health service priorities, academic excellence
and industry needs
• Legislation to streamline ethical approval and
sharing of patient information
• Sustainable funding for core CRC & network
coordination costs
• Funding for academic clinical trials

29. What will an integrated landscape
for clinical research give us?
• Start up speeds, cycle times and
recruitment reliability
that make Ireland a core country for industry-led
scientifically-relevant, multi-centre clinical trials
in specialist fields where the academic partners
are strong.

30. Industry’s contribution to making
Ireland core for clinical trials
• Continue to make the case for building the
network, streamlining processes and health
service commitment.
• Engage with ICRIN, DCCR, CRCs and
therapeutic groups to plan and conduct multi-
centre trials.
• An Irish Clinical Trials Initiative?
– Public/industry partnership to make Ireland a
core country for clinical trials.
– French and Italian models

31. www.MolecularMedicineIreland.ie