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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 Paula Jefferies – Site Relationship Manager Quintiles 11th December 2012
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
7 BILLION HUMANS Over 3.1 Million Individuals in Wales 3
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
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
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
Draft to Executed Contract(global median of 57 days over 52,907 studies)
So What is the Problem in the UK?Site Selection to Site Initiation
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
Thank you for listening...... Paula Jefferies Paula.jefferies@quintiles.com Tel: 07799 470637