Slides from Cutting Edge Information\'s first webinar on the Top 6 Challenges facing thought leader development teams. First delivered in July 2009.

1. Navigating in a Changing Landscape The Top 6 Challenges for Thought Leader Development Teams Presented by: Elio Evangelista Research Manager 1000 Park Forty Plaza, Suite 440 Durham, NC 27701 www.cuttingedgeinfo.com

3. Customized research

4. Capabilities assessments

6. Conflicts of Interest Major events affecting Pharma’s relationship with opinion leaders: Fair-market value compensation State reporting laws Academic institution restrictions The Sunshine Act New PhRMA code Journal publication requirements ACCME policy changes Fewer KOLs Available

7. Our Recent Studies Thought Leader Fair-Market Value KOL Relationship Management

8. The Top 6 Challenges 1 Greater Transparency 2 Establishing Fair-Market Value Procedures 3 State Disclosure Laws 4 Stringent Journal Requirements 5 ACCME Restrictions 6 The Shrinking KOL Pool

9. Challenge 1: Greater Transparency The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): A written contract of the consulting services and basis for payment A legitimate need for the consulting services identified in advance Consultants meet pre-existing criteria and have the necessary expertise A reasonable number or healthcare professionals retained The company maintains records of the services rendered All meetings with consultants relate to the consulting services outlined in the contract

10. Challenge 1: Greater Transparency

12. Challenge 1: Greater Transparency New compensation strategies are the next step for the industry. No more gifting Integrated compensation approach Physician spend tracking Greater reliance on fee schedules Public disclosures

13. Challenge 2: Establishing FMV Procedures “We are under the microscope right now as an industry.” - Interviewed Thought Leader Management Executive

14. Challenge 2: Establishing FMV Procedures Incorporate these steps in your FMV process: Work with your compliance team Start with annual salary data Gather FMV benchmarks Incorporate qualitative research to add context to FMV data Develop a codified fee schedule Tie fee schedules to segmentation data

16. 19 therapeutic areas

17. Fair market value compensation for:

18. Expert-in-Field

19. Specialist

20. Subspecialist

21. Surgeon

22. Primary Care Physician

23. Allied Health Professional

24. Family/General Practitioner

25. Physician Assistant

26. Internal Medicine

27. Nurse

28. Nurse Practitioner

29. OB/GYN

30. Pediatrician

31. Certified Diabetes Educator

32. Dietician

33. Professional Healthcare Educator

35. Challenge 2: Establishing FMV Procedures Annual salary data vs. FMV benchmarks:

36. Challenge 2: Establishing FMV Procedures Influential factors for segmenting thought leaders:

37. Challenge 3: State Disclosure Laws States that have proposed laws on physician disclosures States with laws regulating physician spending

38. Challenge 3: State Disclosure Laws The impact on thought leader compensation: Average Hourly Rate Company Size

39. Challenge 3: State Disclosure Laws The rash of state regulations has prompted some common responses: Companies are avoiding thought leader relationships with physicians in states with complex spend tracking laws. Monitoring changes in these states’ laws has created a burden of extra work at pharmaceutical companies. Many pharmaceutical and biotechnology companies now support passage of the federal Physician Payments Sunshine Act, introduced by US Senators Charles Grassley and Herbert Kohl.

40. Challenge 3: State Disclosure Laws The impact on thought leader management teams: State disclosure laws have not had a great impact on KOL relationships … yet State disclosure laws have led to better documentation systems

41. Challenge 4: Stringent Journal Requirements “For industry-sponsored studies, an analysis of the data (based on the entire raw data set and evaluation of the study protocol, and prespecified plan for data analysis) must be conducted by an independent statistician at an academic institution, rather than by statisticians employed by the sponsor or by a commercial contract research organization.” - JAMA Instructions for Authors

42. Challenge 5: ACCME Restrictions Standards to Ensure Independence in CME Activities: The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. 2.1 The provider must make all decisions regarding the disposition and disbursement of commercial support. 3.1 Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. 5.2

43. Challenge 6: The Shrinking KOL Pool

45. Challenge 6: The Shrinking KOL Pool

46. Challenge 6: The Shrinking KOL Pool Provide top-notch opportunities Research Innovation Development Exposure

47. Presented by: Elio Evangelista Research Manager Cutting Edge Information elio_evangelista@cuttingedgeinfo.com p. +1 919.403.6583 1000 Park Forty Plaza, Suite 440 Durham, NC 27701 www.cuttingedgeinfo.com