1. Strategic Alliance Partnership with CRO
Siew Mien CHAO
Singapore
Sanofi

2. 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

4. 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

5. 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.

6. 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??

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

8. 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

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

10. 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.

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

12. 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

13. Thank You!