This document summarizes key points from ExLPharma's 6th annual MSL Best Practices conference. It discusses the evolving role of medical science liaisons (MSLs) and how they can effectively educate healthcare providers while minimizing compliance risks. The role of MSLs is varied by company but generally involves building scientific relationships with key opinion leaders. The document provides guidance on developing standard operating procedures for MSLs, clarifying their reporting structure, compensation practices, involvement in clinical trials and interactions with sales representatives to reduce promotional concerns. It emphasizes the need for MSL training, oversight and auditing to ensure their activities remain focused on non-promotional scientific exchange.

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

2. Responsibilities of an MSLTravelInvestigatorsTL & InstitutionsProjectsLiterature Keep-upConference CallsFollow-upManaged CareHCPsInt/Ext CommitteesNetworkingMedical MeetingsInternal MeetingsE-mails, etc.Reports

3. Defining the Role of the Medical Science Liaison

4. Traditional Role of the MSLProduct Life Cycle ManagementPre launchKOL identificationDisease state awarenessPhase III involvementLaunchAdvisory boardSpeaker trainingSales trainingManaged care supportPost launchRisk managementISS/IIS/IIT, Phase IV

5. Need for MSL RoleDecreased access to thought leadersPhysician Payment Sunshine ActDecreasing Medical Education GrantsIncreasing complexity of products/devicesAdvocacy

6. BackgroundNomenclature (varied)Medical Science Liaison United States Patent and Trademark Office Serial #73176757 (1989)Medical Science ManagerField Scientific ManagersEducational/professional diversityPharmDPhDMD/DVMRN/NP/PABasic Science Degree/Researcher

7. EtymologyLiaison:Originated in 1640sFrench: 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. 8Medical Science LiaisonPatient Outcomes

9. MSL Balancing ActCompliance

10. External CustomersKey Opinion LeadersLocal, regional thought leadersInsurance/Managed Care/PBMsHealth Care ProvidersAdvocacy groupsCommunity organizationsPatients

11. Internal CustomersBusiness Units/Sales MarketingManaged MarketsRegulatoryClinical Research/DevelopmentMedical Affairs Local/GlobalMedical information/communicationCompliance

12. Maintaining Integrity of MSL roleProvide clear guidelines or SOPs onUnsolicited off label inquiriesHow information is exchanged on unapproved drugsWhat are appropriate interactions with salesWhat role is played when if attends promotional activitiesWhat types of presentations can be provided by MSLShould report to Medical AffairsNumber of MSLs should reflect the defined role within the organization

13. MSL CharacteristicsSolid Scientific backgroundAdvanced DegreeSelf motivatedCutting edge current knowledge in therapeutic areaStays up to date on all research related to therapeutic area productsPersonable/FlexibleAble to easily interact with individuals with varied backgroundsAble to handle urgent business/clinical issuesEnjoys scientific exchange with KOLsMaintains relationships with KOLs

14. 2009 MSL Survey Data DemographicsKupferer, E. (2009) Medical Science Liaison (MSL) Medical Science Liaison Recruitment and Retention. MSL Quarterly, November 2009, ISSN 1547-7886.14

15. Key Areas of ValueMaintain current/cutting edge knowledge within therapeutic areaCreate and maintain science based relationshipsProvide accessibility to KOLReciprocal relationships/perceived value to KOLPerceived as field based Medical ExpertsNon-promotional/unbiased

16. Value ActivitiesKOL interactions/Conference attendanceHealth Outcomes ResearchPatient Advocacy/Community EducationSales trainingSpeaker trainingDisease state awareness/presentationsRisk evaluation and Mitigation Strategies (REM)Involvement with Phase II-IV, Investigator Initiated Trials

17. MSL Training/Continuing EducationCertification of knowledge of current products and therapeutic areaPharmaceutical Detailers LicensingContinuing education requirements and evaluation

18. SummaryMSL role is varied based onTherapeutic areaCompanySimilaritiesHigh level scientific exchangeNon-promotionalReporting structure/credentialsFutureEducational sessions/sharing of best practicesResearch/surveysFocus groups: licensure, certification

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

20. MSL Marketing ConsequencesGovernment: OIG, FDA, DoJ, State Attorneys GeneralCompetitors: Lanham ActConsumers: Product liability, Qui tam

21. Specific ConcernsOIG – Corporate Integrity Policypublic humiliationcompliance officercompliance programcompliance reportsMore than a dozen drug and medical device manufacturers currently have a CIP!

22. Specific ConcernsFDANotice of ViolationWarning LetterSeizureCivil and criminal penalties

23. Specific ConcernsProduct LiabilityPlaintiffs 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 releasesProduct labelingDetail aidsCompany-sponsored CMEMSL-OTL interactionsTell 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 HCPsWhat 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 StateWhat 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 troubleAre 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 - SOPsDo your MSLs have SOPs, and are they trained?off label discussions?CME?Interaction with sales force?

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

33. Practical Ideas -CompensationAre 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 ProductsDo MSLs talk about products in development?What level of involvement for they have in investigator initiated studies?

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

36. ConclusionMSLs 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