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John O'Dea, Enterprise Ireland

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Support for Pharma and Life Sciences Innovation

Support for Pharma and Life Sciences Innovation

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  • Our mission We partner with entrepreneurs, Irish businesses, and the research and investment communities to develop Ireland’s international trade, innovation, leadership and competitiveness The ultimate objective is increased exports, employment and prosperity in Ireland.
  • Driving the establishment of Innovation-Led High Potential Start-ups Stimulating and supporting product and process R&D in EI client companies ultimately leading to export growth Stimulating collaboration between the existing industry base (Overseas and Irish) and Third Level in Ireland and overseas Maximising the drawdown by Irish researchers (industry and academia) from Framework 7 and European Space Agency (ESA) Maximising the commercial return from national investment in state funded research
  • 2005 2006 2007 2008 2009 2010 2011 Licence/ Option/ Assignments 12 28 56 67 95 94 118 Spin-outs 5 8 13 7 35 31 31 Invention Disclosures 135 193 271 407 450 431 399 Patents Applications 83 107 124 202 144 102 139
  • Collaborate with companies/research institutes Access EU and ESA Research Supports Source / licence new technologies R&D and Innovation Funding Access EU and ESA Research and Innovation Supports Share: Share on facebook Share on twitter More Sharing Services Enterprise Ireland can introduce you to many international programmes that stimulate and improve collaboration between companies in different EU member states. We can also help you to tender for contracts from prestigious EU agencies.
  • Industry-led research is a collaborative effort, where companies that might ordinarily be competitors agree to share knowledge, risk and the rewards of pooling their research resources.   There are two programmes that support industry-led research in Ireland Technology Centres Initiative joint initiative between Enterprise Ireland and IDA Ireland allowing Irish companies and multinationals to work together on research projects in collaboration with research institutions. Technology Centres are collaborative entities established and led by industry.  They are resourced by highly-qualified researchers associated with research institutions who are empowered to undertake market focussed strategic R&D for the benefit of industry. For more information, go to Technology Centres Initiative. Industry-led Research Networks Programme (ILRP)   This programme supports medium-term 'shared agenda' research activity among groups of companies that could not afford to fund such research on their own.  The model used engages a wide spectrum of companies with a common interest. This leads to success because the risks and benefits associated with large research projects are shared as are the skills and knowledge built up through working with academic researchers. Projects generally take between 9 months and 2 years to complete and the research is contracted out to a publicly-funded research institution with significant funding available from Enterprise Ireland. For more information, go to Industry-led Research Networks Programme.
  • The PMTC will conduct and coordinate research in advanced pharmaceutical manufacturing technologies which have a wide application across the Irish pharmaceutical industry. The PMTC will assist in the coordination and be an easy access point for the Irish pharmaceutical industry to pharmaceutical related research facilities in Ireland including HEI facilities, Institutes and other Research Centres. The PTMC will work closely with other Irish research centres and academic institutions to source additional funding for Pharmaceutical Manufacturing related research through company specific projects, IDA research funding and EU framework programmes . The PTMC will be a one stop shop to showcase advanced pharmaceutical manufacturing expertise and support academic-industry collaboration in relation to advanced pharmaceutical manufacturing technologies and know-how for manufacturing industry and related service providers.
  • A challenge to a group of Irish based companies to develop a medium term research vision of common commercial interest An opportunity for “self selecting”, interested academic researchers to win funding for executing research projects in response to that vision The research is typically conducted over a 2 year period, and funding is typically in the region of €2M Finished Medical Devices & Medical Aids High tech end-product design, development, manufacture and own IP. This sector has an increasing number of companies in the peripheral-, cardiac- and GI markets which are globally competitive. Many client working with leading academic and clinical expertise and have FDA, NSAI approvals Medical Sub-Supply This sub-sector is experiencing growth at present. Increasing number of precision engineering companies moved into this sub-sector and Companies are backwardly integrating into design and development service and becoming end-to-end ‘solution providers’ rather than component suppliers Diagnostics Genomics, proteomics, microarray, biomarker technology now allow for earlier, faster, more accurate diagnosis
  • A Small Enterprise is defined as : an enterprise that has fewer than 50 employees and has either an annual turnover and/or an annual Balance Sheet total not exceeding €10m   A Medium Sized Enterprise is defined as: an enterprise that has between 50 employees and 249 employees and has either an annual turnover not exceeding €50m or an annual Balance Sheet total not exceeding €43m A large company is a company that employs greater than 250 employees, has either an annual turnover of greater than €50m or an annual balance sheet of greater than €43m.
  • Projects we invest in Eligible Manufacture or internationally tradable service Management control in Ireland High Potential Usually based on technological innovation Export oriented 10 employees within 3/4 yrs, Sales > €1m [but life-science is different!]
  • A process to identify entrepreneurs with strong commercial backgrounds An opportunity to link entrepreneurs to the State Funded Research assets with a view to leading new spin outs A connected up strategy within EI to bring several aspects of the organisation to bear on successful cases Commercialisation Specialists Client Knowledge Services High Potential Start-up Unit Investment Services & Growth Capital
  • Developments in the US have created higher hurdles for Med device companies FDA has made approval process more difficult and less transparent 7 months for a CE approval vs 31 months for FDA Ongoing FDA review of its regulatory process Increase costs , greater uncertainty re approval and reimbursement Europe is seen as a more attractive location for a medical device company CE mark is faster and a more transparent process than FDA Growing reputation in industry Companies get access to EU markets and build commercial and clinical awareness
  • Don’t need complete teams or even complete plans, but must Identify key technology risks of the project and how to overcome Validate hunches about the market and steps needed Economic benefits if is successful Plan for risk elimination at lowest possible cost .
  • Commercial opportunity Quality and innovative aspects of the business plan Return to Irish economy (jobs, exports, cost/benefit) Growth potential Level of risk Achievement of previous milestones or Enterprise Ireland investment targets ( for subsequent rounds of funding)
  • Innovation fund Ireland [additional €250million – half from EI, half from National Pension Reserve Fund] three announced [Polaris Ventures, DJF Esprit, Soffinova Ventures] Tax Based schemes Employment and Investment Incentive Scheme (EII) Max investment in any one company is €10m (max. of €2.5 m in any 12 month period) Income tax relief initially at 30% of amount invested with further 11% tax relief when proven that employment levels have increased by the end of the 3 year holding period. Maximum tax relief in any one tax year is €150,000 Seed Capital Scheme Provides refund (under certain conditions) for PAYE paid over previous 6 years Refund capped on tax actually paid, upper limit on any year of the tax paid on €100k income. Check with your tax advisor and www.revenue.ie
  • Transcript

    • 1. Support for Pharma andLife Sciences InnovationJohn O’Dea, Enterprise IrelandBio Pharma SummitOctober 2012
    • 2. Irish owned enterprise World Class Inward Investment Research 2
    • 3. What I IWill Cover What Will Cover1 Enterprise Ireland’s Role Agenda2 Support for Industry3 Support for Start-ups 3
    • 4. Supporting Innovation in Pharma and Lifesciences• Innovation-Led High Potential Start-ups• Client company investment in R&D• Commercial return from state research• Collaboration between industry and academia• Drawdown by industry and academia from FP7 etc• Seed and Venture Funds
    • 5. Commercialisation Fund Support for commercialisation of research from third-level institutions Commercialisation Fund C PlusCF feasibility - Stages/ Go-No Go Bench Market Typically 2- 5 YEARS
    • 6. Third Level Spin Outs 120 118 100 95 93 80Number 67 LOAs 60 56 Spin outs 40 35 31 31 28 20 12 13 8 7 5 0 2005 2006 2007 2008 2009 2010 2011
    • 7. Date for your diary;Wednesday 28th November Aviva Stadium
    • 8. Innovation Support for industryTechnology Centres(~€2 million p.a. over 5 years)EU FP7, ESAIndustry Led Research projects(~€2-3 million over 2-3 years)Innovation Partnerships Collaboration(up to €300k over 18 months) Complexity NumberR&D Fund: Small Projects [<€150k] PartnersLarge Projects [<€650k]Innovation Vouchers ( €5K) Budget
    • 9. Technology Centres• Irish companies, multinationals, research institutions• Undertake market-focussed strategic R&D• Industry led• Enterprise Ireland and IDA Ireland Usually based in a University with support from partner colleges to deliver on the research needs of the companies
    • 10. Technology CentresBiorefining & Bioenergy Food for HealthIT Innovation Manufacturing ResearchApplied Nanotechnology Energy EfficiencyComposite Materials International Energy CentreMicroelectronics Learning Innovation Connected Health Financial Services Cloud Computing Data Analytics Pharmaceutical Manufacturing
    • 11. Pharmaceutical Manufacturing PMTC• Improve manufacturing competitiveness of Irish sites and companies• Undertake research in advanced manufacturing technology with application to Irish pharma industry.• Source additional funding through company projects and EU programmes .• Showcase advanced pharmaceutical manufacturing expertise• Support academic-industry collaboration
    • 12. Pharmaceutical Manufacturing PMTC Initial research focusProcess Analytical Technology (PAT) to improve costcompetitiveness through • Rapid Microbiological assays • Continuous Processing – as opposed to batch • Soft sensors for process monitoring and control • API-Real Time Release • Packaging/authenticate/trace and security. Brendan Lawlor, Interim Research Manager Brendan.Lawlor@Enterprise-Ireland.com
    • 13. Industry-led Research Networks (ILRP)• Medium-term shared agenda research by groups of companies• Research contracted to a publicly-funded research institution with funding from Enterprise Ireland Animal Health Finished Medical Devices & Medical Aids Diagnostics
    • 14. Innovation Partnerships• Typically individual collaborative projects between companies and researchers• Up to €300k• Up to 80% funding from Enterprise Ireland
    • 15. R&D FundSmall company 45%Medium Company 35%Large Company 25%Simplified Application for Small R&D Fund<€150k
    • 16. So you want to start a technology business; How can we help? 
    • 17. 100 new HPSUs per year, 20% Life-science Background of Promoters Other 5% Serial Promoter Indigenous 16% 37% 3rd Level 10% MNC 32%Most HPSU Entrepreneurs were managers inIndigenous Companies or Multinationals
    • 18. Business Partners
    • 19. Where’s Sally?
    • 20. EI AssistanceThe support you can get from us depends on where you are.1. Get to Investor Readiness • Build Business Plan We’re a 1. Raising investment Development  Agency2. Growing the Business
    • 21. Get to Investor Readiness A Range of Supports Investor Ready Workshops MentorMarket information Pitch preparation New Frontiers Programme Trade Fairs Seed Capital Technology Assessment CertificationInnovation Voucher Value Proposition Workshop Business Angels Introduction to VCs Feasibility Study
    • 22. What we look for at Seed Stage Large Market Opportunity [especially if VC needed] Barriers to Entry [current, future?] High Growth, Scalable
    • 23. HPSU Investment Due Diligence - the Business Plan • Market Risks • Execution Risks • Financial RisksEI funding depends on exports, jobs & cash needEI Investment is in equity [CCRPs]Minimum of matching external fundingAverage initial investment €250k
    • 24. FundingPre-SeedSeed Funds €124 million VC Funds €520 million
    • 25. Applied Process Consulting

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