This presentation describes a state-of-the-art partnership alliance between Otsuka and Covance. It also describes a staffing forecasting model that will be used in the partnership.

1. A New Model for Collaborative Partnerships William H. Carson, M.D. Sr Vice President, Global Clinical Development Otsuka Pharmaceutical Development & Commercialization, Inc. [email_address] David Zuckerman President Customized Improvement Strategies LLC [email_address]

3. The Otsuka Pharmaceutical Group Globally 106 Companies 18 Nations 33,000+ Employees 77 Factories/Plants 18 Research Facilities Healthcare 38% Consumer Products 62% Apr 2009

5. Otsuka 2020 Future State Implies a Substantial Leap Apr 2009 I J H G F D A Otsuka B C Size of Company by R&D Spending (Millions of USD, 2006) Tactical Strategic

7. One-Now, More-Later Proof of Concept Approach 1 2008 2009 2010 2011 2012 Number of CROs Tactical Providers Strategic Partners Work transfers gradually from tactical providers to strategic partner (e.g., end of study, phase or contract period), not all at once Proof of concept (POC) period Add additional Strategic Partners after POC Apr 2009

9. Otsuka’s Outsourcing Initiative Process 1. Identify outsourcing goals & vision for Otsuka CIS works with Executive Team 2. Develop industry benchmarking data Tufts University conducts benchmarking study 3. Determine current Otsuka outsourcing practices & capabilities CIS interviews key executives & managers 4. Perform gap analysis & develop proposed Otsuka outsourcing strategy Utilizing interview and benchmarking data, CIS proposes an Otsuka outsourcing strategy 5. Otsuka outsourcing strategy approved BDCC approves outsourcing strategy 6. Implementation of outsourcing strategy Partner TF forms and works on implementation We are here Apr 2009

13. Future Views If We Fail…. … And If We Succeed Apr 2009

14. The Global Business Partnership Alliance Partnership Crab Apr 2009 Behaviour Values / Mindset (Mutual Trust, Transparency, Commitment) Capabilities Cultural Harmony (Understanding, Respect) Complementary Strengths (Market, Technical, Financial) Sponsorship & Shared Objectives (Ongoing leadership, Alignment, Requirements, Benefits, Interests) Integration & Working Together (Roles & Responsibilities, Relationships, Processes, People / Knowledge Transfer) Communications (Clarity, Openness, Levels, Frequency) Evaluation (Vital Signs, Assessment, Contract) Resources (Time, People, Skills, Finance) Source: GBPA Discovery Projects, 2005-2009

16. One Key to Success: Accurate Forecasting Otsuka Pipeline Otsuka Product Development (PD) Level Probabilistic Forecasts Otsuka PD Level & CRO Staffing & Mgmt Probabilistic Forecasts CRO Trial-level Point Forecasts CRO Multi-Trial Staffing Point Forecasts (Bottom Up) The missing link Apr 2009 Integrated Pipeline & Staffing Forecast

17. How Does the Staffing Model Work? IND Phase 1 Phase 2 Phase 3 NDA Post Launch Annual Pipeline Additions 12 13 14 1 2 3 4 5 6 7 Current Pipeline 8 10 Planned Pipeline 9 11 Run probabilistic simulation (typically 500 cases) Generate portfolio, staffing and management forecasts Feb 09 Apr 2009

18. Calculating the Staffing Forecast Apr 2009 Pipeline Single case output: 5-Year Otsuka + CRO Staffing & Management Forecast Calculate staffing required Calculate CRO staffing required Calculate Otsuka management required Calculate Otsuka staffing gaps Otsuka Staff

19. Example Result: Total Requirements Apr 2009 Otsuka Staffing Shortfall CRO Staffing Requirement Otsuka Management Requirement

21. Questions Apr 2009 ? ? ? ? ? %*@#$% !!!