The Role of Clinical Research in securing the Future of the Industry in Ireland – A Molecular Medicine Ireland perspective

Ruth Barrington Chief ExecutiveMolecular Medicine Ireland

1

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

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

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

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.

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

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

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

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.

Clinical Trials Capacity – a national priority?

• Ireland ‘a leading country for the timing, access and relevance of clinical trials’. Renewed Programme for Government

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

Clinical Trials Capacity – a national priority?

• Building clinical research capacity at the core of – the Health Research Action Plan

(DOHC/DETI)– HRB Business Strategy

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

Clinical Trial Activity in Ireland

Applications of IMP Clinical Trials reviewed by the IMB

2002 2003 2004 2005 2006 2007 2008 20090

50

100

150

200

IMP STUDIES APPROVED BY IMB 2009

PHASE 1 PHASE 2 PHASE 3 PHASE 4 TOTAL0

20

40

60

80

100

120

20 18

46

13

97

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

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

COMMERICAL & NON-COMMERCIAL CTS APPLICATIONS

IRELAND

DENMARK

90 10

70 30

NON-COMMERICAL%

COMMERICAL%

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.

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.

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

ICRIN Vision

Ireland is a country of choice for

scientifically relevant multi-centre

clinical studies and trials in specialist

fields where partners are strong.

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)

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

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

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

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

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

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.

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

www.MolecularMedicineIreland.ie