Maximizing the Effectiveness of the Partnership with your CRO

• 1. FOCUSED. TRUSTED. GLOBAL.EXPERTS Maximizing the Effectiveness of thePartnership with your CRO Alita M Hassan, MPH Director, Proposal Feasibilities

2. FOCUSED. TRUSTED. GLOBAL. Drug Development over the past 13+ years o 1996 CRA fully integrated teams very efficient and effective Team collaboration Autonomy Execution Strong Site Relations o 2000 Pfizer acquires Parke Davis Monitors De-centralized Start of outsourcing utilizing Functional Service Provider model o 2002 all operations de-centralized and centralized to New London, CT Site selections, budgets, PMs etc. 3. FOCUSED. TRUSTED. GLOBAL. Drug Development over the past 13+ years o Strategic Teams Discovery Early Clinical Development Teams Similar to the model followed by industry today o 2004 Director on one of the Strategy Teams left in Ann Arbor utilized Full Service Provider as the continuity for the development of the compound was of great importance o 2008 Ann Arbor site closure 4. FOCUSED. TRUSTED. GLOBAL. Current State of Affairs o Industry under tremendous pressure International competition Increased Regulatory Oversight Issues around pricing Investigational Product Pipeline o Pressures to make the right decision Scientifically, Clinically, Regulatory and Commercial o Pressures to execute correctly on those decisions Selecting the right CRO organizing people, resources, and timelines Getting things done on time, within budget, and with quality 5. FOCUSED. TRUSTED. GLOBAL. Different Outsourcing Models o Full service Integrated companies with global capabilities Handling all aspects of operations Advantage of integration o Functional service provider Focused on best in class Research team with coordination internally or by a lead CRO Advantage that if done well it provides best in class performance 6. FOCUSED. TRUSTED. GLOBAL. Matching Your Needs o Know the needs of your organization Global CRO/niche CRO Full service/functional service provider/combination o Ensure matching synergistic organizational systems Internal expertise Resources Knowledge Experience 7. FOCUSED. TRUSTED. GLOBAL. Effective Outsourcing via Partnering o Partnering on therapeutic basis with integration of strategic consulting and operations o Full service model preserves clear accountability and avoids inefficient hand-off between groups 8. FOCUSED. TRUSTED. GLOBAL. Strategic Alliance o Relationship between sponsor and CRO that is managed by an executive team and not by the study team directly involved in the project o Two committees are identified: An Operations Committee consisting of director level management from each functional area. Responsible for oversight of key performance metrics, process improvement and first point of escalation for project teams An Executive Committee consisting of senior managers with responsibility for oversight of the Operations Committee and development of strategic direction of each organization and how it fits into the relationship 9. FOCUSED. TRUSTED. GLOBAL. Alliance Operational Benefits o Ensures that proper communication, transparency of operational performance, and timely escalation of essential decision making is executed for achievement of success as measured by the Sponsor o Minimizes miscommunication, delays in decision making, and distracting political agendas from frustrating the project progress or setting the wrong priorities 10. FOCUSED. TRUSTED. GLOBAL. Alliance Operational Benefits o Allows operational staff to focus on their primary responsibilities and avoids micromanagement of processes by Sponsor staff with limited knowledge of processes and personnel at the CRO o Results in cost savings by avoiding cumbersome reporting and management through multiple study teams and resulting redundancy of effort 11. FOCUSED. TRUSTED. GLOBAL. Alliance Operational Benefits o Dramatically reduces costs in many instances by providing a framework in which the CRO can use appropriate risk management analysis to collaboratively identify labor (cost) saving processes tailored to the program o Reduces costs by minimizing CRO business development activities and Sponsor management of multiple vendors 12. FOCUSED. TRUSTED. GLOBAL.EXPERTS2009 Avoca Report The State of Clinical Outsourcing 13. FOCUSED. TRUSTED. GLOBAL. Demographics Sponsor respondents:4 1 23 Pharmaceutical Biotechnology Device Other72 14. FOCUSED. TRUSTED. GLOBAL. Demographics Service provider respondents:15CRO 4Imaging 8Laboratory 2ConsultingOther 71 15. FOCUSED. TRUSTED. GLOBAL. Highlights of Study Relationships, Relationships, Relationships o Achieve greater levels of efficacy in outsourcing relationships o Maintain higher standards for service provider evaluation o Utilize performance and relationship management mechanisms o Form strategic relationships to curtail development and to market timelines 16. FOCUSED. TRUSTED. GLOBAL. Increased Efficacy in Outsourcing o Intensify delineation of expectations at study inception phase o Smaller budget + reduced headcount = bigger results o Performance/metric reporting o Implement functional Lessons Learned o Increase technology platforms for communication * Better measurement of provider performance and the use of preferred providers were ranked as the highest priority for sponsors future work 17. FOCUSED. TRUSTED. GLOBAL. Measurement Mechanisms o Modify current KPIs to adequately evaluate the service provider activity and performance o Adjust to account for quality of deliverables rather than strictly timing and quantity o Set rigorous standards for justifying work as quality o Capture relationship metrics/KRIs to increase efficiency 18. FOCUSED. TRUSTED. GLOBAL. Have you Formed Strategic Partnerships? Sponsor responses:12Yes10No 43Dont KnowN/A 35 19. FOCUSED. TRUSTED. GLOBAL. Have you Formed Strategic Partnerships? Service provider responses: Service provider responses:77 Yes 16 No Dont Know N/A73 20. FOCUSED. TRUSTED. GLOBAL. Case Study in Partnership o Partnering with the Sponsor, what went right? Proposal Thorough review of protocol (protocol considerations) Study feasibility Realistic timeline estimates Award Expectations Responsibilities Execution Study start-up Site relations Recruitment process Adhere to timelines Outcome 21. FOCUSED. TRUSTED. GLOBAL. Case Study in Partnership o Introduction of Sponsor and relationship Roles and responsibilities Empowerment and trust in team Responsible and collaborative oversight of Sponsor 22. FOCUSED. TRUSTED. GLOBAL. Case Study in Partnership o Best practices from study Study start-up Timelines meet initial deliverables Recruitment Pre-screen at time of feasibility to ensure strong site selection Initiate priority sites prior to investigators meeting Encourages healthy competition Relationship with sites o Lessons learned Study start-up 23. FOCUSED. TRUSTED. GLOBAL. Case Study in Partnership o Benefits to Sponsor in alliance model Continuity and knowledge of processes Efficiencies in costs Reputation in industry Competitive advantage in development timeline 24. A well thought out strategic partnershipbetween a sponsor anda CRO results in theoptimization of trial quality, time, and money 25. FOCUSED. TRUSTED. GLOBAL.EXPERTSThank you! Alita M. Hassan, MPH Director, Proposal Feasibilities Medpace IncCincinnati, Ohio