1. © Proprietary and Confidential 1 Investigator Cost Analysis By Therapeutic Area Custom Queries For AEC Partners Third Delivery Rafael Campo Michael G. Kahn MD, PhD Frank Cattie Fast Track Systems {rcampo,mkahn,fcattie}@fast-track.com 12 September 2006

2. © Proprietary and Confidential 2 Background Data Investigator costs and facility overhead extracted from Fast Track Systems’ TrialSpace Grants Manager: PICAS ® industry cost benchmarking database. –~110,000 investigator contracts –~50 pharmaceutical and biopharmaceutical companies Extracted data limited to 2000-2006, Phase II-III studies only All costs converted to US$ using currency conversion rates published in Wall Street Journal on 1-August, 2006 Countries: France, US, Germany, UK, Italy, Poland

3. © Proprietary and Confidential 3 Analysis Methodology Three analysis data sets All study locations (Affiliated + Non-affiliated) Hospital-based studies (=“Affiliated’) only Non-hospital based studies (= “Non-affiliated”) only Dependent/predicted variables –Adjusted cost per patient MCA (Multiple Classification Analysis is a robust form of ANOVA: Analysis of Variance), which models country-specific costs adjusted for phase, year and affiliation MCA modeled successfully "All study locations" data set for all countries MCA was unsuccessful in modeling "Affiliated" and Non-Affiliated" subsets for certain countries due to the singular nature of one or more of the covariates. –Unadjusted (raw) mean & median cost per patient, affiliated versus non-affiliated Uses all available data without any statistical adjustments –More sensitive to underlying data collection distribution than ANOVA estimates Median is more conservative/robust estimate than mean Provides data on all therapeutic areas, all countries –Percent overhead charges for affiliated (hospital-based) studies

4. © Proprietary and Confidential 4 Sequence of Results Sequence 1: Adjusted Mean Cost Per Patient –Slides 5 - 27 –All therapeutic areas, all countries –By Country by Year overall and by key therapeutic areas –By Therapeutic Area by Year Sequence 2: Adjusted Mean Cost Per Patient by Affiliation –Slides 28 - 34 –Only those therapeutic area and countries where ANOVA model created a modeled value Sequence 3: Unadjusted (Raw) Mean Cost Per Patient by Affiliation –Slides 35 - 41 –All therapeutic areas, all countries Sequence 4: Unadjusted (Raw) MEDIAN Cost Per Patient by Affiliation –Slides 42 - 48 –All therapeutic areas, all countries Sequence 5: Unadjusted percent overhead for affiliated (hospital- based) studies –Slide 49 –Mean, 25%-50%-75%'tiles (50%tile = MEDIAN)

5. © Proprietary and Confidential 5 Adjusted Mean Cost Per Patient – All Study Locations

6. © Proprietary and Confidential 6 Adjusted Mean Cost Per Patient – All Study Locations

7. © Proprietary and Confidential 7 Relative Adjusted Mean Cost Per Patient – All Study Locations (For each TA, USA = 1.0)

8. © Proprietary and Confidential 8 Adjusted Mean Cost per Patient by Country and Year

9. © Proprietary and Confidential 9 Adjusted Mean Cost per Patient by Country and Year

10. © Proprietary and Confidential 10 Adjusted Mean Cost per Patient by Country and Year - Oncology

11. © Proprietary and Confidential 11 Adjusted Mean Cost per Patient by Country and Year – Central Nervous System

12. © Proprietary and Confidential 12 Adjusted Mean Cost per Patient by Country and Year - Cardiovascular

13. © Proprietary and Confidential 13 Adjusted Mean Cost per Patient by Year - France

14. © Proprietary and Confidential 14 Adjusted Mean Cost per Patient by Year – United States

15. © Proprietary and Confidential 15 Adjusted Mean Cost per Patient by Year – United Kingdom

16. © Proprietary and Confidential 16 Adjusted Mean Cost per Patient by Year - Germany

17. © Proprietary and Confidential 17 Adjusted Mean Cost per Patient by Year - Italy

18. © Proprietary and Confidential 18 Adjusted Mean Cost per Patient by Year - Poland

19. © Proprietary and Confidential 19 Adjusted Mean Cost per Patient by Therapeutic Area and Year

20. © Proprietary and Confidential 20 Adjusted Mean Cost per Patient by Therapeutic Area and Year

21. © Proprietary and Confidential 21 Adjusted Mean Cost per Patient by Year - Cardiovascular

22. © Proprietary and Confidential 22 Adjusted Mean Cost per Patient by Year – Central Nervous System

23. © Proprietary and Confidential 23 Adjusted Mean Cost per Patient by Year – Anti-Infective

24. © Proprietary and Confidential 24 Adjusted Mean Cost per Patient by Year - Oncology

25. © Proprietary and Confidential 25 Adjusted Mean Cost per Patient by Year - Endocrine

26. © Proprietary and Confidential 26 Adjusted Mean Cost per Patient by Year - Respiratory

27. © Proprietary and Confidential 27 Adjusted Mean Cost Per Patient Affiliated /Non-Affiliated By Country Blank cells = MCA ANOVA unable to adjust means No adjusted means generated for Italy

28. © Proprietary and Confidential 28 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated - Cardiovascular

29. © Proprietary and Confidential 29 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated–Central Nervous System

30. © Proprietary and Confidential 30 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated – Anti-Infective

31. © Proprietary and Confidential 31 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated - Oncology

32. © Proprietary and Confidential 32 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated - Endocrine

33. © Proprietary and Confidential 33 Adjusted Mean Cost Per Patient Affiliated versus Non-Affiliated - Respiratory

34. © Proprietary and Confidential 34 Unadjusted (Raw) Mean Cost Per Patient Affiliated /Non-Affiliated By Country

35. © Proprietary and Confidential 35 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated - Cardiovascular

36. © Proprietary and Confidential 36 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated–Central Nervous System

37. © Proprietary and Confidential 37 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated – Anti-Infective

38. © Proprietary and Confidential 38 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated - Oncology

39. © Proprietary and Confidential 39 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated - Endocrine

40. © Proprietary and Confidential 40 Unadjusted (Raw) Mean Cost Per Patient Affiliated versus Non-Affiliated - Respiratory

41. © Proprietary and Confidential 41 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated /Non-Affiliated By Country Median = value where at most half the population have values less than the median and at most half have values greater than the median. A robust measure of central tendency that is insensitive to extreme outliers.

42. © Proprietary and Confidential 42 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated - Cardiovascular

43. © Proprietary and Confidential 43 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated–Central Nervous System

44. © Proprietary and Confidential 44 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated – Anti-Infective

45. © Proprietary and Confidential 45 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated - Oncology

46. © Proprietary and Confidential 46 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated - Endocrine

47. © Proprietary and Confidential 47 Unadjusted (Raw) MEDIAN Cost Per Patient Affiliated versus Non-Affiliated - Respiratory

48. © Proprietary and Confidential 48 Overhead charges for affiliated (hospital-based) studies

49. © Proprietary and Confidential 49 High-level Conclusions Adjusted mean CPP: –Oncology > CNS >> All others –USA >> UK > Germany > France ≈ Italy Unadjusted median CPPs are consistently higher than unadjusted mean CPPs –Implies CPP distributions are "right-tailed" (a few unusually high CPP studies are in the data set) Unadjusted %overhead: –USA ≈ UK >> France ≈ Germany ≈ Poland –Italy does not support non-affiliated studies –Hospital-based charges are not a major additional cost in Europe other than in UK Overhead costs in UK equals or exceeds USA overhead costs.