Strategic Alliance Partnership with CRO Siew Mien CHAO Singapore Sanofi

CRO Market Overview – General Trends Development Spend – In-house vs. Outsourced Several Factors that lead to this increasing outsourcing trends: Relying on outsourcing providers to help deal with cost pressures and speed time to market in a competitive market place Reduced need for capital investment Outsourcing currently represents 53% of global development spend This is expected to increase to 60% by 2020 Source: Baird Report, October 2015. Note outsourcing spend includes investigator fees

Service Providers: Market Overview 3 year trends for large, mid-tier and niche providers Niche providers will focus on narrow slices of the market de fined by region, therapeutic ar ea or indication level Large CROs continue to be be st positioned to partner strate gically as sponsors seek to narrow their vendor lists to who can deliver against a dive rse and high volume of projects Global scale that matches the resource needs Breadth of therapeutic expertise Customer service capabilities End-to-end integrated tools Mid-tier providers will seek greater scale to better posit ion themselves strategic rel ationships There is an outsourcing space for everyone. Increasing competitiveness and complexity of global drug development demands flexible pa rtnering models Need to bring new drugs to market more quickly and cost efficiently, while maintaining patient safety and data integrity

Key Clinical Outsourcing Objective To build an outsourcing strategy and organization to support a growing need to externalize clinical services in order to compliment the internal capabilities and therapeutic expertise.

Clinical Outsourcing Strategy Transactional Outsourcing Fragmented by service and fully transactional. Full Operational Outsourcing Full operational & strategic integration of CRO resources with the sponsor’s global program team making the relationship less transactional. This model moves beyond the execution of clinical trials to trial design and strategic input into clinical development plans, and requires different skillsets and expertise. Balanced Outsourcing??

Strategic Partnership Considerations Assess Capabilities and Market Providers Define Outsourcing Algorithm Define Governance Structure Identify Right Skills Needed “Oversight” Develop Training Metrics, Metrics, Metrics

Assess Capabilities and Market Providers Sponsor Internal Capabilities Research Infrastructure and directions Strengths & Weaknesses Market Providers Capabilities Due Diligence on Providers Do they complement the Sponsor? Culture, Goals and Expectations Duplication/complementary of skillsets/infrastructure Defining Outsourcing Algorithm

Strategic Partnership Considerations Assess Capabilities and Market Providers Define Outsourcing Algorithm Define Governance Structure Identify Right Skills Needed “Oversight” Develop Training Metrics, Metrics, Metrics

Transitions to Strategic Partnership Creating a platform for alliance partnership : Shared decision making, Delivery of broad cross-study solutions, Performance assessments, Shared risk and reward structures.

Communication Main challenge to partnership Failure to listen to legitimate request to either party compromise outcome to the study

Clinical Outsourcing Strategy Transactional Outsourcing Fragmented by service and fully transactional. Full Operational Outsourcing Full operational & strategic integration of CRO resources with the sponsor’s global program team making the relationship less transactional. This model moves beyond the execution of clinical trials to trial design and strategic input into clinical development plans, and requires different skillsets and expertise. Balanced Outsourcing Full operational & strategic integration of CRO resources with the sponsor’s global program team making the relationship less transactional to compliment the internal Sponsor capabilities and therapeutic expertise

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