Irish Clinical Research Infrastructure Network (ICRIN) and Molecular Medicine Ireland (MMI)

1. Irish Clinical Research Infrastructure Network (ICRIN)Fionnuala GibbonsClinical Trial Liaison Officer“Ireland A Location of Choice for Medical Technology Clinical Investigations”13th September 2012 1

2. Irish Clinical Research Infrastructure Network (ICRIN) and 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 and with ICRIN to build a sustainable national system to coordinate, support and promotetranslational and clinical research

3. ICRIN Vision • Ireland as a country of choice for scientifically relevant multi-centre clinical studies and trials in specialist fields where partners are strong. • Requires a national, distributed research infrastructure

4. ICRIN – Funding Streams

5. The ICRIN Team

6. ICRIN Team siobhan.gaynor@molecularmedicineireland.ie fionnuala.gibbons@molecularmedicineireland.ie susan.lennon@molecularmedicineireland.ie suzanne.bracken@molecularmedicineireland.ie www.MolecularMedicineIreland.ie

7. Research Infrastructure Translational, Academia, Clinical Investigators, SMEs, Multi-national companies, Health Departments Exploratory, POC, Phase I to IV, Observational Registries Harmonised, Fit for Purpose, Predictable, Cost Effective Flexible, Innovative, “Research Ready”, Focussed IMP, Diagnostic, Device, Health Outcomes Core Research Infrastructure 7

8. Web Portal Development News, Events & Links Research System Navigator Research Tools and Guidelines Research Centre & Site Locator e Learning and Education Connecting, Supporting and Promoting Irish Research Innovators Industry & Enterprise Research Networks Members Zone

9. Clinical Research Centres/Facilities

10. Directory of CRC/F’s in Ireland 1. Directory of Clinical Research Centres/Facilities in Ireland In Ireland there are currently seven Clinical Research Centres/ Facilities with resources for treating patients in clinical studies, access to principal investigators and services for study set-up, treatment of patients, bio-banking etc. They are located in: • 1. Cork - HRB Clinical Research Facility Cork, Mercy University Hospital • Click here for link to CRFC website. • 2. Dublin - National Children's Research Centre, Our Lady's Children's Hospital, Crumlin • 3. Dublin - Royal College of Surgeons in Ireland (RCSI) Clinical Research Centre, Beaumont Hospital • 4. Dublin - Wellcome Trust HRB Clinical Research Facility, Trinity College Dublin, St. James's Hospital • 5. Dublin - University College Dublin Clinical Research Centres: • (a). Mater Misericordiae Hospital • (b). St. Vincent's University Hospital • 6. Galway - Health Research Board Clinical Research Facility, Galway (CRFG), National University of Ireland, Galway (NUIG) • Click here for link to CRFG website. • Click on the links above to view the details of each individual CRC/CRF. • Click here to download the ICRIN Directory of all 7 CRC/F’s operating in Ireland

11. Clinical Research Centre/Facility

12. Service Providers

13. Directory of Service Providers 2. Directory of Clinical Service Providers in Ireland • Biometrics (Data Management, Statistics, Electronic Data Capture) • Cardiovascular Monitoring Services • Clinical Insurance Services • Clinical Research Organisations- Pharmaceutical, Device, Diagnostics Development • Clinical Research Organisations- Food • Contract Clinical Staff • Computer Systems Validation • Consulting Services • (a). Market Access and Health Economics • (b). Fundraising, Licensing, Commercialisation and Company Product Validation • (c). Market Analysis and Validation, Patent/Competitor Landscaping • (d). Managed Intellectual Property Service • (e). Medical Devices/ Diagnostics Regulatory Consulting • (f). Regulatory for Pharmaceutical Development • Courier Services • Diagnostics Development • Legal Services for Clinical Research • Manufacturing/Storage/Transport • Medical Devices/ Quality Management Systems • Qualified Person (QP) IMP Product Release Services • Quality Assurance • Regulatory Services • Regulatory/ Technical Compliance • Web Design

14. Categories

15. Links

18. ICRIN Working Group Objectives • Working with CRC/F’s, Research Groups and Disease Networks Focus is: • Streamlining regulatory and ethical approval, site specific approval processes, • Process Harmonisation • Quality Management System • IT and Data Management Systems • Cost Harmonisation for core trial services – Industry and Non-Commercial

19. MedicalDevice Development

20. Clinical Trial Liaison Officer • CTLO role funded by Enterprise Ireland • Establish relationships with clinical researchers in indigenous/multinational medical device, pharmaceutical, biotech companies and universities/institutes of technology • Establish links with Key Opinion Leaders in a variety of therapeutic areas • Promote Ireland as a location for clinical trials for multi-national pharmaceutical, biotech , medical device companies

21. Clinical Trial Liaison Officer • Ensure Ireland is seen as Highly Competitive • Be aware of Cost sensitivities for development • Ireland viewed by industry as a one stop shop for Clinical research • International standards applied to all research in line with EU and FDA requirements

22. CTLO Service’s Prototype Development/ Pre-clinical Assessment Health Technology Assessments Safety Monitoring & Vigilance Quality Management System Trial Risk Management Informed Consent Management Regulatory and Ethical Requirements Introduction to Therapeutic Specialist Technical, Market & Clinical Assessment Life Cycle Management Packaging / Labeling Manufacturing Product Feasibility Investigational Trial Design/Management CTLO

23. What have we done to date? ICRIN Launch – 25th January 2007 New Report published by ICRIN: Clinical Research - Irish Situation Analysis - April 2009 ICRIN with the State Claims Agency host Clinical Research Insurance and Indemnity Workshop – April 2009 Certificate in Nursing (Clinical Research) course - Sep 2009

24. What have we done to date? MMI/ICRIN hosts Workshop on Clinical Studies for Medical Devices – Oct 2009 MMI Technology Platform Web-Portal is now live – Dec 2009 DCCR Dublin Centre for Clinical Research MMI/ICRIN contributes to ECRIN publications – Feb 2010 Pilot Common Ethics Form now available – Feb 2010

25. What have we done to date? 2 day Workshop “Health Technology Assessments and Re-imbursement process for Medical Devices” – June 2010 Clinical Research Roadmap is launched – June 2010 MMI agrees position paper calling for Ireland's continued participation in EU biobanking and clinical research infrastructures – June 2010 MMI strengthens national network to support industry-sponsored trials and creation of ICRIN Working Group – June 2010

26. What have we done to date? MMI/ICRIN chair sessions for “Irish Heart Foundation Collaborative Cardiovascular and Stroke Research Network Inaugural Conference” June 2010 MMI Guidelines for Standardised Biobanking - Publication Now Available – July 2010 MMI publishes Annual Report 2009 – July 2010

27. What have we done to date? “Clinical Investigations for Medical Devices” September 2011 MMI/ICRIN Workshop on Hospital Approval of Clinical Trials -January 2012 “Provide a number of lectures on MSc in Clinical Research, in NUIG, UCD and TCD” “Introduction to the Legal and Insurance Requirements for Medical Device Clinical Investigations” June 2012

28. What have we done to date? 28

29. Make Europe a Single Area for Clinical Research • Pan-European, distributed infrastructure providing coordinated services to multinational clinical research in Europe: • - access to patients and to expertise throughout Europe • despite the fragmentation of health and legislative systems • support to investigators and sponsors in multinational studies • ICRIN European Correspondent A pan-European infrastructure for clinical research in any disease area

30. Summary of ICRIN Activities • Research Readiness Report, with recommendations • Provided clinical research training to over 600 personnel from the academic, hospital, SME and Pharmaceutical sectors • Report on competent clinical research training current and future needs • Created 12 research topic workshops, 10 clinical research topic courses and 15 training modules in research practice and clinical trial operations

31. Summary of ICRIN Activities • Developed a web portal of resources, SOPs, templates, maps (http://www.molecularmedicineireland.ie/page/g/t/69 • Developed a directory of Irish clinical research centres/facilities http://www.molecularmedicineireland.ie/page/g/t/69#CRC_Directory • Completed a survey and gap analysis of the national research community

32. Summary of ICRIN Activities • Two cost modelling template’s (Site Model & Support Services Model) • Worked with hospitals to harmonise/streamline the hospital approval process for multi centre studies • Established a biomarker network (http://www.molecularmedicineireland.ie/page/g/t/44) • Report on research training, including a gap analysis • Report on “ Driving the Development of Excellent Health Research – Supporting Research Groups

33. Bio-Banking Network

34. MMI Network: Bio-banking • National Biobanking Initiative → National approach for bio-banking • Link existing bio-banks • Structured & harmonised high quality samples and data • Sustainable • EU Network: BBMRI - Biobanking and Bio-molecular Resources Research Infrastructure • Preparatory phase funded by European Framework FP7 • To develop a pan-European bio-banking network of all bio-bank sample types • MMI involved in preparatory phase for Ireland with BBMRI

35. MMI Blueprint for National Biobanking Model • GeneLibrary Ireland Design Phase Report • Governance and management structure • Ethical/ legal issues e.g. ownership of tissue • Access to samples and/or data • MMI Guidelines for Standardised Biobanking • To ensure consistent sample quality and harmonisation across the different clinical research centres • Internationally peer reviewed • ISBER Biopreservation and Biobanking Journal 2010 8;1: 3-63www.liebertonline.com/toc/bio/8/1 • Adopted by BBMRI

36. Irish Biomarker Network • Partner idea facilitated by MMI • Sharing expertise in biomarker discovery, validation & commercialisation • Launched at workshop on 4 November 2010 – FDA, IMB, academics and industry present

37. MMI Technology Platform Web-Portal

38. MMI Technology Platform Web-Portal Centralised Web-Portal to showcase and promote Technology Platforms and associated expertise that support clinical and translational research in molecular medicine in academic institutions across Ireland Methodology: Questionnaire for details of TP Identification of TPs across partner institutions: websites, word of mouth, etc. Initiated site visits to get an overview of technology and the issues and discuss information to be captured

39. Education & Training

40. MMI Courses & Workshops in Clinical & Translational Research • Short taught courses, lecture-based and practical. • Designed for a wide audience. • Straightforward online application process. • Developed and delivered by faculty from multiple academic institutions and industry. • Supported by commercial sponsorship and fees. • Participant feedback drives continual development. • Move to online/blended learning.

41. MMI Courses & Workshops Examples: • Techniques & Strategies in Molecular Medicine • MMI/Pfizer: Molecules to Medicines • Drug Design & Delivery • Introduction to Data Analysis • Human Disease Genomics: SNPs, GWAS and Next-Gen Sequencing • Cancer Biology to Cancer Medicine • Epigenetics: From Mechanisms to Medicines • Microarray Analysis • Proteomics: Methods & Applications The Education & Training Team work with ICRIN Team to offer training in the clinical research space, including regular Good Clinical Practice workshops

42. MMI PhD Training Programmes in Clinical & Translational Research • Clinician Scientist Fellowship Programme (CSFP) • From 2008 medical graduates are undertaking PhD studies in five academic institutions as MMI Clinician Scientist Fellows with shared national structured training (funded through PRTLI Cycle 4) • Clinical & Translational Research Scholars Programme (CTRSP) • From 2011 science graduates are undertaking a unique cross-institutional 4-year structured PhD Programme, with industry involvement in programme governance, courses, placements and mentoring (funded through PRTLI Cycle 5) • Over 90 principal investigators in four universities • Placements in clinical research facilities • Placements in pharmaceutical and medical device companies • Focus on transferable skills with industry-based mentors

43. Clinical & Translational Research Scholars Programme Timeline

44. CTRSP Industry Engagement

45. Dublin Centre for Clinical Research (DCCR)

46. Dublin Centre for Clinical Research (DCCR) • In 2006 three Dublin Medical Schools (TCD, RCSI and UCD) responded to a Wellcome Trust call to fund clinical research infrastructure. • Dublin application scored second and this resulted in €23M in funding from the Wellcome Trust and Health Research Board: • ~€10m the development of a Clinical Research Centre (CRC) at St. James’s Hospital. • Five years operational funding (~€13m) for DCCR Network and St. James’s Hospital Clinical Research Facility • St. James Hospital CRF – expected to open in H1, 2011

47. Dublin Centre for Clinical Research Vision Transformation of clinical research in Dublin through development of physical, human resource and administrative infrastructure for safe, ethical and excellent patient-focused research

48. DCCR Relationships Irish Clinical Research Infrastructure Network (ICRIN) DCCR Consortium Board • Emergent Clinical Research Organisations • NUIG Galway • UCC Cork • Crumlin DCCR DCCR Network Management Team DCCR Thematic Research Groups Diabetes & Metabolism Pulmonary Medicine • International Relationships • ECRIN • NICRIN (NI) • UKCRN • Wellcome Trust CRFs Inflammatory Skin Disease Neuropsychiatry DCCROperations Team Infectious Disease & HIV Neurodegen. Prostate Cancer Ophthalmology

49. Wellcome Trust – HRB Clinical Research Facility

50. Vision For The Future Ireland - the location of choice for R&D, manufacturing and marketing of highly innovative products and services • Improving patient health outcomes with efficient and effective new product development • Cutting edge of regulatory developments • Ensure that products placed on the market are safe and effective