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The role of clinical research in securing the future of the industry in Ireland



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

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



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The role of clinical research in securing the future of the industry in Ireland The role of clinical research in securing the future of the industry in Ireland Presentation Transcript

  • The Role of Clinical Research in securing the Future of the Industry in Ireland – A Molecular Medicine Ireland perspectiveRuth Barrington Chief ExecutiveMolecular Medicine Ireland
  • 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 institutionsand their associated hospitals to build a sustainable national system to coordinate, support and promotetranslational
    and clinical research
  • MMI Board – Academic/Industry Partnership
    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
    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
  • 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 IrelandApplications of IMP Clinical Trials reviewed by the IMB
    Ref: StintaGestrelius, Nordic Co-operation in Clinical Research - Opportunities and Challenges (18 February 2009 & updated 30 March 2009)
  • 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
    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
    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
    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