This document discusses the challenges of sourcing comparator drugs for clinical trials and strategies for reducing costs. It outlines regulatory requirements, industry changes, and supply chain complexities that make comparator drug procurement difficult. The document then presents several strategies for reducing costs, such as sourcing directly from innovators, procuring from low-cost markets, using generics, consolidating comparators and placebos, and coordinated supplier relationship management.

1. Sourcing Comparator Drugs Pharmaceutical organizations support Comparator requirements differently. To a large extent these differences are driven by availability and experience of their internal resources.

2. Sourcing Comparator Drugs One common denominator remains the same for all of us and that is the overall complexity and challenge of securing an uninterrupted supply of clinical drug requirements continues to become more demanding.

3. Some Challenges Associated With Purchasing Comparator Drugs Regulatory requirements FDA, EMA, MHRA, etc. Changes in the Pharmaceutical Industry mergers and acquisitions Work force compression Import/export requirements Individual drug requirements storage and handling conditions Spiraling cost of drugs Uncertainty surrounding health care reform

4. All Eyes on Savings Reducing waste and minimizing loss are part of productivity initiatives that many companies have put in place In their own right these programs have contributed savings but have also created a secondary hurdle to overcome: a JIT inventory scenario.

5. No Room For Error The lead time from the purchase of a Comparator Drug through blinding and into the Clinical sites has almost eliminated any room for error in a process that has ample opportunity for things to go wrong

6. Unlocking Opportunities to Reduce Overall Cost of Comparator Drug EARLY INVOLVEMENT IS ESSENTIAL We work closely with key decision makers from the beginning to understand requirements and implement strategies

7. Comparator Drug Procurement Strategies There are several paths we can take to reduce cost and drive savings Direct to Innovator Low Cost Market Generic Alternative Comparator/ Placebo Consolidation Market Consolidation

8. Purchasing the product direct from the innovator can significantly reduce cost But… Competitors are not always willing Comparator Drug Procurement Strategies Direct to Innovator Low Cost Market Generic Alternative Comparator/ Placebo Consolidation Market Consolidation

9. Sometimes product can be purchased in low cost regions If supporting documentation can be obtained Comparator Drug Procurement Strategies Direct to Innovator Generic Alternative Comparator/ Placebo Consolidation Market Consolidation Low Cost Market

10. Generic alternatives are an easy way to reduce cost if available Comparator Drug Procurement Strategies Direct to Innovator Low Cost Market Comparator/ Placebo Consolidation Market Consolidation Generic Alternative

11. Consolidating the comparator and placebo from a single source can provide cost reduction, and a number of synergies A recent opportunity secured a >60% cost reduction (more than $6MM) Comparator Drug Procurement Strategies Direct to Innovator Low Cost Market Generic Alternative Market Consolidation Comparator/ Placebo Consolidation

12. Consolidated sourcing in South Korea allowed for significant cost reduction, and a number of other synergies Comparator Drug Procurement Strategies Direct to Innovator Low Cost Market Generic Alternative Comparator/ Placebo Consolidation Market Consolidation

13. Comparator Drug Procurement Strategies All of these can be effective strategies to reduce costs .. But we do not implement these alone Direct to Innovator Low Cost Market Generic Alternative Comparator/ Placebo Consolidation Market Consolidation

14. Supplier Relationship Management We work closely with our key suppliers to develop a long term coordinated approach. Individual competencies Global reach Integrity Financial stability Potential for Growth

15. THANK YOU QUESTIONS?