Partnerships in Clinical Trials Asia Pacific: Tailoring Outsourcing Strategies for the Asia-Pacific Region – Functional Insourcing

Chee Hwee Lim, Director of Clinical Operations, Asia Pacific Region, COVANCE

Three stages of Outsourcing evolution
1980s/1990s – Tactical outsourcing by big Pharma
2000-2005 – Biotech/specialty Pharma use outsource strategically
2005 – Partnerships models emerge between Pharma/CRO – Why? Cost benefit analysis.

What’s the current marketplace in the Pharma/Biotech industry?
Pharma:
-75% of global research comes from global Pharma
-It’s mostly done inhouse.

Biotech:
-25% of development spending
-50% of molecules in development
-Limited internal capacity, use of outsourcing is prevalent

Partnership Models:
Limited Competitivge Pool of Two CRO Models
Partnership in Growth
Sole Source Relationship
Functional Service Provider
Integrated Service Alliance

What is a critical success factor?
-Cultural fit
-Aligned Corporate Goals
-Maintain positive public employee perceptions
-Develop a solution with mutually beneficial economic characteristics
-Maintains continually in current workflow

What are the drivers for outsourcing?
-Product pipeline streamlining
-Opportunity to focus on core competence or activities
-Cost savings
Notice where the costs are coming from. Realize the longterm benefit of saving costs.
-Reducing the time to market: We can have a bigger focus of getting drugs to market faster.
-Expertise and specialization: Someone else could have more knowledge about a subject, and they may be able to better to the project with you

Integrated drug development services:
-Central labs, ECG, Clinical, etc are all one combined service. It’s from Phase I to Phase IV.
Full/Partial Clinical Services
-They have all or most of the clinical service components, including feasibility ans site selection, project management, clinical monitoring, and can be from Phase I to Phase IV.

What is best in Asia Pacific?
The Standalone and in sourcing will allow you to exert some control.

How do you successfully outsource? Fear is one of the things hold companies back from successful outsourcing. How do you choose your outsourcing strategy?
--Prior to making the decision to outsource, you must make an internal assessment.
--In Asia Pacific, what are the reasons to shift outsourcing to more tactical than strategic?


What's your opinion?