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Breaking down barriers - costing and study set-up

Breaking down barriers - costing and study set-up . Andrew Copestake, Ph. D. Vice President Business Development – Europe ICON. The Drive to Outsource. Global Outsourcing Market Estimates. CRO market estimated to be US$15.4bn (2004) R&D spend estimated at US$73.6bn (2004)

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Breaking down barriers - costing and study set-up

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  1. Breaking down barriers - costing and study set-up Andrew Copestake, Ph. D. Vice President Business Development – Europe ICON

  2. The Drive to Outsource

  3. Global Outsourcing Market Estimates CRO market estimated to be US$15.4bn (2004) R&D spend estimated at US$73.6bn (2004) CAGR over next 3 years ranges around 15%

  4. Quintiles 10.4% Other PPD 51% 7.8% Parexel 3.2% Covance 5.2% Charles River MDS Kendle ICON 1.3% 0.2% 1.7% 3% PRA 2.7% CRO Market Analysis Quintiles, PPD, Covance and Parexel are the largest competitors to ICON in the market for Phase II and III services. Source: MDSPS Business Planning Group estimates.

  5. Business Models

  6. CRO Cost Drivers • Indication (Complexity) • Duration (Recruitment) • Number of Patients • Number and Location Sites • Size CRF • Services (Scope) Cost is derived on a per task or FTE basis – just like the site

  7. Investigator/Site Fees • Set by Pharma or CRO in discussion with site but mindful of budgetary constraints on both organisations CRO Pharma Site

  8. Site Contracting Scenarios • Site Template Agreement • CRO Template Agreement • Pharma Template Agreement • Tripartite Agreement

  9. Site Template Agreement Site CRO Pharma Site Provides Template Agreement to CRO CRO Reviews and amends where possible without involving Pharma Certain Revision Require Pharma Authorisation

  10. CRO Template Agreement Site may seek Insurance & Indemnity directly from Pharma Pharma Site CRO Little if any Pharma involvement Reviewed by Site Negotiated with CRO CRO provides template contract to site containing specific language around indemnity and insurance provision plus CRO disclaimer

  11. Pharma Template Agreement (1) CRO signs on behalf of Pharma CRO signs on behalf of Pharma Pharma grants CRO Power of Attorney Site CRO Pharma Any amendments discussed between CRO and site

  12. Pharma Template Agreement (2) CRO signs as CRO Pharma provides Template but not Power of Attorney Any amendments discussed Between CRO and site Site CRO Pharma CRO amends contract to reflect Pharma obligations (indemnity,insurance etc) versus CRO responsibilities

  13. Tripartite Agreement CRO and Pharma Sign Site CRO Pharma Any amendments discussed between CRO and Pharma and must be acceptable to both Some Trusts, CROs and Pharma Co do not accept the agreement

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