1. April 29-30, 2010 Arlington, VA Highlights from ExLPharma’s 6th MSL Best Practices

2. Responsibilities of an MSL Travel Investigators TL & Institutions Projects Literature Keep-up Conference Calls Follow-up Managed Care HCPs Int/Ext Committees Networking Medical Meetings Internal Meetings E-mails, etc. Reports

3. Defining the Role of the Medical Science Liaison

4. Traditional Role of the MSLProduct Life Cycle Management Pre launch KOL identification Disease state awareness Phase III involvement Launch Advisory board Speaker training Sales training Managed care support Post launch Risk management ISS/IIS/IIT, Phase IV

5. Need for MSL Role Decreased access to thought leaders Physician Payment Sunshine Act Decreasing Medical Education Grants Increasing complexity of products/devices Advocacy

7. Etymology Liaison: Originated in 1640s French: liaison "a union, a binding together," Latin: ligationem "a binding,“ (ligament) 1806: Sense of "intimate relations" 1816: Military sense of "cooperation between branches, allies” The noun meaning: "one who is concerned with liaison of units, etc." Retrieved from Etymology online on April 9th from http://www.etymonline.com/index.php?search=liaison&searchmode=none

8. 8 Medical Science Liaison Patient Outcomes

9. MSL Balancing Act Compliance

10. External Customers Key Opinion Leaders Local, regional thought leaders Insurance/Managed Care/PBMs Health Care Providers Advocacy groups Community organizations Patients

11. Internal Customers Business Units/Sales Marketing Managed Markets Regulatory Clinical Research/Development Medical Affairs Local/Global Medical information/communication Compliance

12. Maintaining Integrity of MSL role Provide clear guidelines or SOPs on Unsolicited off label inquiries How information is exchanged on unapproved drugs What are appropriate interactions with sales What role is played when if attends promotional activities What types of presentations can be provided by MSL Should report to Medical Affairs Number of MSLs should reflect the defined role within the organization

13. MSL Characteristics Solid Scientific background Advanced Degree Self motivated Cutting edge current knowledge in therapeutic area Stays up to date on all research related to therapeutic area products Personable/Flexible Able to easily interact with individuals with varied backgrounds Able to handle urgent business/clinical issues Enjoys scientific exchange with KOLs Maintains relationships with KOLs

14. 2009 MSL Survey Data Demographics Kupferer, E. (2009) Medical Science Liaison (MSL) Medical Science Liaison Recruitment and Retention. MSL Quarterly, November 2009, ISSN 1547-7886. 14

15. Key Areas of Value Maintain current/cutting edge knowledge within therapeutic area Create and maintain science based relationships Provide accessibility to KOL Reciprocal relationships/perceived value to KOL Perceived as field based Medical Experts Non-promotional/unbiased

16. Value Activities KOL interactions/Conference attendance Health Outcomes Research Patient Advocacy/Community Education Sales training Speaker training Disease state awareness/presentations Risk evaluation and Mitigation Strategies (REM) Involvement with Phase II-IV, Investigator Initiated Trials

17. MSL Training/Continuing Education Certification of knowledge of current products and therapeutic area Pharmaceutical Detailers Licensing Continuing education requirements and evaluation

18. Summary MSL role is varied based on Therapeutic area Company Similarities High level scientific exchange Non-promotional Reporting structure/credentials Future Educational sessions/sharing of best practices Research/surveys Focus groups: licensure, certification

19. Minimize Risk of Medical Science Liaison non-Compliance with Federal, State, and Industry Requirements

20. MSL Marketing Consequences Government: OIG, FDA, DoJ, State Attorneys General Competitors: Lanham Act Consumers: Product liability, Qui tam

21. Specific Concerns OIG – Corporate Integrity Policy public humiliation compliance officer compliance program compliance reports More than a dozen drug and medical device manufacturers currently have a CIP!

22. Specific Concerns FDA Notice of Violation Warning Letter Seizure Civil and criminal penalties

23. Specific Concerns Product Liability Plaintiffs may say, “Your product hurt me and you told doctors to ignore the indications and safety information in the approved product labeling!” Defendants may say, “But it was peer-to-peer scientific discussion.” What might the media report or a jury say?

24. But MSLs Only Talk About Science? Government enforcement agencies build a case from everything you do. Press releases Product labeling Detail aids Company-sponsored CME MSL-OTL interactions Tell your legal and regulatory department what message you want to get out. They will put the pieces together and analyze the risk.

25. MSL, OTL, and HCPs What are the risks?

26. What do MSLs do? Talk to doctors? Recruit and retain OTLs? Comply with legal, regulatory, and company requirements? Competitive intelligence? Take science to the world? Deliver pizza and make copies?

27. MSL Talks to HCP About Disease State What is the risk? The disease state your MSL talks about is off-label for your drug, and your sales rep goes into the office the same day. Your MSL goes to a specialist to talk about a drug that has no on label use in that specialty. Your MSL goes to specific offices picked by the sales force.

28. But “S” Means Science! And I’m liaisoning! Titles are irrelevant. What matters is what actions you are taking. Could a firm hire all MDs as sales reps and send them out to promote off-label as doctor to doctor communication? No! The same goes for MSL to physician interactions.

29. But What About OTLs? They are tender and fragile and need constant MSL attention. Your firm wants the OTLs to be good scientists who give good independent advice. Don’t get your OTLs in trouble Are you paying them reasonable fair market value? Are you asking them to do to much? You don’t want them to lose credibility.

30. OTL Role? Speaker’s bureau? CME presenter? Consultant? Clinical trial investigator? Investigator initiated study grant recipient?

31. Practical Ideas - SOPs Do your MSLs have SOPs, and are they trained? off label discussions? CME? Interaction with sales force?

32. Practical Ideas - Reporting Does “S” stand for Science or Sales? Who manages the MSL day to day operations, and over-all strategy?

33. Practical Ideas -Compensation Are MSLs paid from the R&D budget, or the sales budget? Are they compensated for developing good, new OTLs, or for sales in the territory?

34. Practical Ideas – New Products Do MSLs talk about products in development? What level of involvement for they have in investigator initiated studies?

35. Practical Ideas - Audit Great, you have SOPs. Now what? Audit, audit, audit! Are MSLs following the SOPs? What are MSLs and sales reps doing together?

36. Conclusion MSLs are very important for your products. Healthcare provider education is critical. Healthcare provider and industry relationships are under scrutiny from everyone. Ask yourself, how does this look to an outsider?

37. Want to attend next year’s conference? For additional information on ExLPharma’s MSL Best Practices Conferences, please visit www.exlpharma.com