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Outsourcing

Outsourcing. CRO perspective. Roger Hayes, Ph.D. Current Opportunities. R&D spend anticipated to grow in 2013 and beyond 5% current projection Numbers of active programs to increase Manage R&D budgets by reducing infrastructure and internal resources Increased demand for CROs

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Outsourcing

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  1. Outsourcing CRO perspective Roger Hayes, Ph.D.

  2. CurrentOpportunities • R&D spend anticipated to grow in 2013 and beyond • 5% current projection • Numbers of active programs to increase • Manage R&D budgets by reducing infrastructure and internal resources • Increased demand for CROs • Clinical outsourcing will predominate • Late-stage pipeline still the focus • Continued expansion of services • MPI Research expanding from predominantly early-development into Discovery and Phase 1

  3. Preferred & Strategic Partnerships • Early development (safety assessment) studies have become a commodity • Low profit margins • Is quality equal across all competing CROs? • How does one differentiate services? • Competitive bid process or partnership approach with preferred pricing? • 33% of early-stage work is performed through strategic partnerships • Partnerships have expiration dates • Maintain relationship to renew contracts • Communication • Budget planning, study/protocol deviations, institutional knowledge transfer

  4. Partnerships • How many different ways are there to run an IND-enabling toxicology study? • Extension of sponsor laboratory or well travelled path to submission success • Institutional knowledge transfer is critical • Study design • Formulation issues • Anticipated toxicities • Control of study • A CRO is likely to be more routinely inspected by regulatory authorities • De-risk to avoid Form 483 observations • Undue influence by sponsor • Role of test facility management

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