1. 12 January 2011 Hani Zaki, MPH, MBA Senior Vice President, Late Phase Services PRA International Future Challenges of Clinical Development: A View from the CRO

3. Clinical Trials By The Numbers 100,838 trials registered on ClinTrial.gov as of January 3, 2011 40,998 trials are Pharma based 10,192 are “enrolling” 8,824 Interventional 4,633 Safety Outcome 20,982 are US based

4. Current Working Relationship Working Standards, Process, Logistics, Efficiency & Quality Metrics Resource Shift

6. CRO Economic Forces Development Research (Pharma) Global CRO Business Arlington Mills, Lawrence, MA in 1907

7. Clinical Research Stock Index First Clinical Research Index (FCRI). Calculated as the mean average percentage change from baseline, dividends excluded, adjusted for stock splits. In other words, the indices are not weighted for stock price or market capitalization. Prices are in local currencies. Index components may change from time to time based on new listings, mergers and other factors. Components include 11 publicly traded clinical research stocks: BioClinica (BIOC:US), CMIC (2309:JP), Covance (CVD:US), Datatrak International (DATA:US), EPS Co., Ltd. (4282:JP), eResearchTechnology (ERES:US), ICON (ICLR:US), Kendle International (KNDL:US), Medidata (MDSO:US), PAREXEL International (PRXL:US), and PPD (PPDI:US). In 2010, MDS Pharma Services (MDZ:US) exited the clinical research business, Phase Forward (PFWD:US) was acquired, and Encorium Group (ENCOD:US)’s stock price dropped below $1/share and became too volatile to include in the index. Vol. 7, No. 1, January 2011 “Can You Handle the Truth?” Subscribe free at www.firstclinical.com © 2011 First Clinical Research First Clinical Research Stock Index (FCRI)

9. Patent Expiration 2008-2015 $66B in Annual Sales 2011 expirations Total $35.2B

10. Global Pharma ROI

11. Flat R&D Budgets Pharmaceutical R&D as a Share of Sales: 1970 -2008

12. Increasing Cost of Trials

13. Relief in Sight? Big Firms Poised to Spend Again Saturday, January 1, 2011 By JAMES R. HAGERTY and DANA MATTIOLI

15. Pharma Clinical Trial Volume by Phase Source: CT.gov

17. An Early Geographic Trend

20. Comparative Costs By Geography

21. Trends in Investigator Fees

23. Some Trends and Needs Trends Needs Significant decrease in NME approvals (revenue) at 40x the expense Development efficiencies Increasing cost of late phase (II, III, IV) development New processes, technology & Innovation Global trials with increasing needs in CEE, Asia, MENA, Africa Global resources, training, standardization Fierce competition for study patients Medical informatics and utilization of emerging new data resources Pharma and Biotech relaying on outsourcing to re-structure expense from fixed to variable CROs leading change in processes, logistics, metrics, delivery and quality

24. Future Look

25. Challenge: New Efficiencies Lead Innovation Lead Efficiency Lead Delivery Metrics Lead Quality Metrics Active Approach: Suppliers Setting New Standards Balanced Collaboration Global Bio-Pharmaceutical Industry Discovery Innovation Licensing Supply competitiveness, savings, flexibility, global reach, insight ….

26. Clinical Trial Costs Is this the most efficient process? Can we do better to reduce burden? Are we building effective partnerships?

27. Challenge: Technology & Innovation Must be a joint effort between industry, suppliers and regulators Break from 1970’s thinking and processes and re-draw the mechanics of conducting clinical research based on today’s realities, resources and capabilities

28. How Fast Can We Adapt?

29. US Adoption of EMR/EHR

30. Challenge: Broader Geographies Accelerating the rate of enrollment in clinical trials toward reduced costs and quicker results Finding the right patients and navigating narrow inclusion and exclusion criteria Greater competition for patients and the need for larger sample sizes to detect slight differences Ethical considerations Regulatory Oversight

31. Challenge: Registration vs “Real World” Safety & Efficacy Generalized Safety & Effectiveness

32. Challenge: Access to Patients Vast cultural differences on healthcare “privacy.” Nordic countries have a tradition of health registries. Every citizen is provided with an identifier from birth and enrolled into registries to elucidate epidemiological trends. Data are used for public health research and improvement of medical care. Can we guarantee healthcare privacy as we break new ground to accelerate research? Can we generalize across countries?