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An Industry View of Working in NHS Wales

An Industry View of Working in NHS Wales. Paula Jefferies – Site Relationship Manager Quintiles 11 th December 2012. Quintiles Introduction . Quintiles conducts the largest number of commercial Clinical Trials in the UK

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An Industry View of Working in NHS Wales

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  1. An Industry View of Working in NHS Wales Paula Jefferies – Site Relationship Manager Quintiles 11th December 2012

  2. Quintiles Introduction • Quintiles conducts the largest number of commercial Clinical Trials in the UK • Quintiles conducts trials on behalf of the majority of BioPharma companies in the UK/globally • The UK is a key market and Quintiles is committed to protecting and growing the UK market • Quintiles is in a unique position to provide comparative data on performance which has been previously difficult to access

  3. 7 BILLION HUMANS Over 3.1 Million Individuals in Wales 3

  4. The Path is Marked by Great Risk Development Pressures: Stakeholders Scrutiny Patient Access Demands Commercialization Stakeholders R&D Timelines Productivity Patent Cliff Product Pipelines High Price tag • Current estimates for bringing a drug to market in the U.S. and E.U. exceed $1 billion. – Health Economics, February 2010 Regulatory Pressures: Complexity Approval Times Intense FDA/EMA Scrutiny Ethical Concerns Financial Pressures: Costs Capital Constraints Demand for Value Payer Pressure ROI

  5. Quintiles Site Relationships Tactical Strategic Transformational Prime Sites Partner Sites • Access to large volumes of patients in multiple therapeutic areas • Joint corporate governance • Dedicated staffing • Infrastructure/capacity development • Strategic planning • Close collaboration • Relationship actively managed • Process alignment for efficiency • Pipeline /capacity planning • Therapeutic capability usually limited Investigator Sites • Relationship re-invented with every study; • Little consistency or value for either party 1-2 studies per year 5+ studies per year 20+ studies per year 1 CRA per study Relationship Manager Alliance Manager Multiple CRAs Dedicated CRAs

  6. Welsh Sites have been key to our delivery of UK patient recruitment targets Since 2002.......... • 487 patients into 49 protocols • 10 sites over 4 Health Boards • 68% of these patients were recruited since 2009 from 2 Health Boards / NHS Trusts and 1 primary Care facility

  7. Draft to Executed Contract(global median of 57 days over 52,907 studies)

  8. So What is the Problem in the UK?Site Selection to Site Initiation

  9. Site Initiation Visit to FPFV

  10. Conclusion • Research has an elevated profile in Wales • Infrastructure to support ie: NISCHR AHSC • Health Research Wales – single portal • Unified approach – process simplification / alignment • Established research centres offering wealth of experience and keen Investigator database • Diverse patient population • Ultimate aim is to differentiate performance against the UK to attract more successes

  11. Thank you for listening...... Paula Jefferies Paula.jefferies@quintiles.com Tel: 07799 470637

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