Current trends, issues and challenges facing MSL's in the pharmaceutical industry. Presented at the 7th MSL Best Practices conference, April, 2010. For further information, please visit www.exlpharma.com

1. Highlights from ExLPharma’s7th MSL Best Practices Forum

2. 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 2

3. Need for MSL Role Decreased access to thought leaders Physician Payment Sunshine Act Decreasing Medical Education Grants Increasing complexity of products/devices Advocacy 3

4. 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

5. Medical Science Liaison Patient Outcomes 5

6. External Customers Key Opinion Leaders Local, regional thought leaders Insurance/Managed Care/PBMs Health Care Providers Advocacy groups Community organizations Patients 6

7. Internal Customers Business Units/Sales Marketing Managed Markets Regulatory Clinical Research/Development Medical Affairs Local/Global Medical information/communication Compliance 7

8. 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 8

9. 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 9

10. 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 10

11. 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

12. Critical Success Factors of MSL Role Time Management Critical to Success Take Advantage of Flexibility Built into Job Description Prioritize activities to avoid adverse events Work to Live – Not Live to Work

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

14. Specific Compliance 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!

15. Specific Compliance Concerns cont. FDA Notice of Violation Warning Letter Seizure Civil and criminal penalties

16. Specific Compliance Concerns cont. 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?

17. 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.

18. 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.

19. 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.

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

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

22. 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?

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

24. 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?

25. Summary MSL role is varied based on Therapeutic area Company Similarities High level scientific exchange Non-promotional Reporting structure/credentials Future Take all appropriate steps to ensure proper training and compliance Educational sessions/sharing of best practices Research/surveys Focus groups: licensure, certification 25