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Highlights From 7th Medical Science Liaison/MSL Conference

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Highlights From 7th Medical Science Liaison/MSL Conference

  1. 1. Highlights from ExLPharma’s7th MSL Best Practices Forum<br />
  2. 2. Traditional Role of the MSLProduct Life Cycle Management<br />Pre launch<br />KOL identification<br />Disease state awareness<br />Phase III involvement<br />Launch<br />Advisory board<br />Speaker training<br />Sales training<br />Managed care support<br />Post launch<br />Risk management<br />ISS/IIS/IIT, Phase IV<br />2<br />
  3. 3. Need for MSL Role<br />Decreased access to thought leaders<br />Physician Payment Sunshine Act<br />Decreasing Medical Education Grants<br />Increasing complexity of products/devices<br />Advocacy<br />3<br />
  4. 4. Responsibilities of an MSL<br />Travel<br />Investigators<br />TL & Institutions<br />Projects<br />Literature Keep-up<br />Conference Calls<br />Follow-up<br />Managed Care<br />HCPs<br />Int/Ext Committees<br />Networking<br />Medical Meetings<br />Internal Meetings<br />E-mails, etc.<br />Reports<br />
  5. 5. Medical Science Liaison<br />Patient Outcomes<br />5<br />
  6. 6. External Customers<br />Key Opinion Leaders<br />Local, regional thought leaders<br />Insurance/Managed Care/PBMs<br />Health Care Providers<br />Advocacy groups<br />Community organizations<br />Patients<br />6<br />
  7. 7. Internal Customers<br />Business Units/Sales <br />Marketing<br />Managed Markets<br />Regulatory<br />Clinical Research/Development<br />Medical Affairs Local/Global<br />Medical information/communication<br />Compliance<br />7<br />
  8. 8. Maintaining Integrity of MSL role<br />Provide clear guidelines or SOPs on<br />Unsolicited off label inquiries<br />How information is exchanged on unapproved drugs<br />What are appropriate interactions with sales<br />What role is played when if attends promotional activities<br />What types of presentations can be provided by MSL<br />Should report to Medical Affairs<br />Number of MSLs should reflect the defined role within the organization<br />8<br />
  9. 9. MSL Characteristics<br />Solid Scientific background<br />Advanced Degree<br />Self motivated<br />Cutting edge current knowledge in therapeutic area<br />Stays up to date on all research related to therapeutic area products<br />Personable/Flexible<br />Able to easily interact with individuals with varied backgrounds<br />Able to handle urgent business/clinical issues<br />Enjoys scientific exchange with KOLs<br />Maintains relationships with KOLs<br />9<br />
  10. 10. Key Areas of Value<br />Maintain current/cutting edge knowledge within therapeutic area<br />Create and maintain science based relationships<br />Provide accessibility to KOL<br />Reciprocal relationships/perceived value to KOL<br />Perceived as field based Medical Experts<br />Non-promotional/unbiased<br />10<br />
  11. 11. 2009 MSL Survey Data Demographics<br />Kupferer, E. (2009) Medical Science Liaison (MSL) Medical Science Liaison Recruitment and Retention. MSL Quarterly, November 2009, ISSN 1547-7886.<br />14<br />
  12. 12. Critical Success Factors of MSL Role<br />Time Management Critical to Success<br />Take Advantage of Flexibility Built into Job Description<br />Prioritize activities to avoid adverse events<br />Work to Live – Not Live to Work<br />
  13. 13. MSL Marketing Consequences<br />Government: OIG, FDA, DoJ, State Attorneys General<br />Competitors: Lanham Act<br />Consumers: Product liability, Qui tam<br />
  14. 14. Specific Compliance Concerns<br />OIG – Corporate Integrity Policy<br />public humiliation<br />compliance officer<br />compliance program<br />compliance reports<br />More than a dozen drug and medical device manufacturers currently have a CIP!<br />
  15. 15. Specific Compliance Concerns cont.<br />FDA<br />Notice of Violation<br />Warning Letter<br />Seizure<br />Civil and criminal penalties<br />
  16. 16. Specific Compliance Concerns cont.<br />Product Liability<br />Plaintiffs may say, “Your product hurt me and you told doctors to ignore the indications and safety information in the approved product labeling!”<br />Defendants may say, “But it was peer-to-peer scientific discussion.”<br />What might the media report or a jury say?<br />
  17. 17. But MSLs Only Talk About Science?<br />Government enforcement agencies build a case from everything you do.<br />Press releases<br />Product labeling<br />Detail aids<br />Company-sponsored CME<br />MSL-OTL interactions<br />Tell your legal and regulatory department what message you want to get out.<br />They will put the pieces together and analyze the risk.<br />
  18. 18. MSL Talks to HCP About Disease State<br />What is the risk?<br />The disease state your MSL talks about is off-label for your drug, and your sales rep goes into the office the same day.<br />Your MSL goes to a specialist to talk about a drug that has no on label use in that specialty.<br />Your MSL goes to specific offices picked by the sales force.<br />
  19. 19. But “S” Means Science!<br />And I’m liaisoning!<br />Titles are irrelevant.<br />What matters is what actions you are taking.<br />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.<br />
  20. 20. Practical Ideas - SOPs<br />Do your MSLs have SOPs, and are they trained?<br />off label discussions?<br />CME?<br />Interaction with sales force?<br />
  21. 21. Practical Ideas - Reporting<br />Does “S” stand for Science or Sales?<br />Who manages the MSL day to day operations, and over-all strategy?<br />
  22. 22. Practical Ideas -Compensation<br />Are MSLs paid from the R&D budget, or the sales budget?<br />Are they compensated for developing good, new OTLs, or for sales in the territory?<br />
  23. 23. Practical Ideas – New Products<br />Do MSLs talk about products in development?<br />What level of involvement for they have in investigator initiated studies?<br />
  24. 24. Practical Ideas - Audit<br />Great, you have SOPs. Now what?<br />Audit, audit, audit!<br />Are MSLs following the SOPs?<br />What are MSLs and sales reps doing together?<br />
  25. 25. Summary<br />MSL role is varied based on<br />Therapeutic area<br />Company<br />Similarities<br />High level scientific exchange<br />Non-promotional<br />Reporting structure/credentials<br />Future<br />Take all appropriate steps to ensure proper training and compliance<br />Educational sessions/sharing of best practices<br />Research/surveys<br />Focus groups: licensure, certification<br />25<br />

Editor's Notes

  • Medical science liaison programs have an integral place in the life-cycle development of a product within a therapeutic area. Medical science liaisons are critical in clinically-driven, optimal positioning of a company’s therapeutic capability in a given geography at a given product life cycle. Clinical support during the pre- and post-launch phases of a product is top priority of medical science liaisons and is achieved through sustained scientific exchange with thought leaders. The establishment of trust in a medical science liaison-thought leader relationship results from consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought leaders.
  • There are several legal/regulatory and historical changes that have provided an opening for the introduction or expansion of MSL teams.
  • The purpose of the MSL position is at its very core is to positively affect patient outcomes via the dissemination of clinical information, developing reciprocal relationships with key thought leaders.
  • These are just a few ways in which the MSL role can be clearly defined within the organization to maintain the integrity and clarity of the purely scientific role.
  • Maintain current cutting edge knowledge within therapeutic areaCreate Science based relationships that provide accessibility to KOLReciprocal relationships that also provide perceived value to the KOLPerceived as field based Medical ExpertsNon-promotional/unbiased
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