Clinical Industry Engagement

1. Clinical Industry Engagement Dr. Brian O’Neill Head of Lifesciences 13th September 2012 Ireland – Location of Choice for Medtech Clinical Investigations

2. Highlights 2011…

3. EMPLOYMENT = 138,488 SPEND IN ECONOMY = €17.9bn IRISH OWNED COMPANIES FOREIGN OWNED COMPANIES EMPLOYMENT = 145,983 SPEND IN ECONOMY = €17.0bn IRISH GOODS €2.2bn PAYROLL€5.4bn IRISH GOODS €7.7bn PAYROLL€7.6bn IRISH SERVICES €8.2bn IRISH SERVICES€3.9bn Source: 2010 ABSEI, 2011 Forfás Employment Survey It’s about Jobs and Economic Impact 100,000 Jobs by 2016

4. Pharma & Medtech models globally are under strain, therefore Ireland INC also has a problem 4

5. Evolution of Medical Technologies • 1990’s • Dynamic monitoring • Titanium prosthetics • Pulse oximetry • Dissolving sutures • Non latex gloves • Molecular diagnostics • 2000s • Drug eluting stents • Hybrid prosthetics • Minimally invasive devices – surgical, cardiac, pulmonary • Intubation devices • Imaging – new contrast & equipment • Remote Monitoring • Medical Services • Advanced Materials • Companion Diagnostics • Advanced Clinical Trials – Biomarkers, Imaging, Software • 2020 • E-Everything • Integrated Connected Health Networks • Hospital to Home • Regenerative Scaffolds & Stem Cells • New Materials • BioDevices • Next generation • Bespoke Biomedical Solutions • Virtual Robotic Surgery Design, Development, Prototyping, Commercialisation, Manufacturing, Supply Chain, Services Servicisation of Drug & Device Industry!!! Prevention/Wellness/Compliance Healthcare Intelligence – Data Management / Data Analytics 1980’s • Silk & catgut suture • Latex gloves • Heavy Medical Equipment (beds) • Mechanical Respirators • Anaesthetic machines

6. 250 Clients – 50% Medical Technologies 20 new start-ups per year / MBO’s Medical sub-supply, finished devices (e.g., cardio-, peripheral, orthopaedics, NOTES), diagnostics, specialist services, connected health €1bn+ Sales, Exports €760m, Employment of 6,000 people 9% export growth in 2011 & 8% employment growth Indigenous Life Sciences

7. Help fund and commercialise research for the benefit of Industry

8. Enterprise Ireland’s Role in Supporting Innovation New Innovation-Led High Potential Start-ups Client investment in R&D for international competitive differentiation Maximising commercial return from national investment in research Stimulating collaboration between industry base and Academia Maximising drawdown by industry and academia from Framework 7 and European Space Agency

9. Growth in R&D performance by Enterprise Ireland client companies 750 55 743 715 710 707 54 51 52 624 601 49 515 42 40 33 300 25 2005 2006 2007 2008 2009 2010 2011 Year > €100,000 R&D Spend > €2 million R&D Spend Increase in Number of EI clients with Significant (€2m) and Meaningful (100k) R&D Spend

10. Research to Market through Innovation Technology Licence Start-up Co Established Co Large Co Applied Research Pre- Start-up Global Life Science Team Commercialisation Fund Innovation Vouchers Innovation Partnerships Fund 100% academic research fund €400k Company-specific Funding Technology Centres

11. Technology Transfer Performance 2005-2011

12. Destination of Licences 2008-2011

13. Evolution of Existing Industry • Leadership • Competitiveness • Broadened Mandates • Higher Value-Added Activities • Integrated Value Propositions • Clinical Engagement

14. Development Process ABC ABC ABC ABC Stakeholder Engagement Vital ABC & patients, regulatory bodies, Ethics Committees

15. EI is the major financial sponsor • €750k direct funding over 3 years • Exceptional talent • New technologies • New companies

16. Clinical Trials Liaison Officer • Directly supports researchers, clinicians and companies to develop and deliver cutting edge research in a safe and regulated environment. • Engaged >250 companies, researchers and service providers • 70 research projects, 60 HPSU, 50 pre-start-ups, 60 established companies, 20 MNCs and 72 clinical service providers. • Provided support and advice to a number of companies contemplating setting up their clinical trials here in Ireland. • Promotes Ireland as a location for clinical trials. • Facilitated over 150 contacts between clinicians and companies.

17. Healthcare Innovation Hub Action Plan for Jobs 2012 7 • Deliver a Health Innovation Hub to drive collaboration between the health system and commercial enterprises leading to the development and commercialisation of new healthcare technologies, products, services and start‐ups emerging from within the health system and/or firms. Innovative Health Research + Quality Health Services + Economic Success

18. International Health Systems

19. Enterprise Ireland/Cleveland Clinic Clinical Innovation Award • Overall winner in 2011 was Dr. Niall Davis of Mid-Western Regional Hospital in association with the University of Limerick – Solution for safe catheterisation of the urinary bladder. • Discovered by CTLO • €15k feasibility grant • €400k Comm Funds • Company-specific supports

20. Health Research Group National Clinical Research Framework Implementation of the Action Plan for Health Research

21. MedinIrelandIreland’s Largest Medical Technologies Showcase “Surgical Innovations – Bringing Clinical Research to Market” Irish Heart Foundation, MMI, Barry McMahon (Tallaght), Jim Egan (Mater) Derek Young (i360 Medical/RCSI)

22. Thank you Contact details: brian.oneill@enterprise-ireland.com