Medical science liaison programs are expanding in today’s biopharmaceutical industry.
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.
Defining the role of the MSL isn’t as easy as it may seem. The MSL role is fairly new profession with a relatively small workforce, that lacks a common or direct career path. Many MSLs will tell you they just “happened” into the industry. There is also a great diversity in educational and primary career backgroundsThe term MSL was originally trademarked in 1967 by UpJohn and consisted of promoted top sales representatives. ER Squibb then created an all MD MSL workforce 1989 which set the standard for MSL teams going forward. Today, MSLs are considered to be therapeutic experts with advanced scientific training and degrees in life sciences (doctorates, advanced professional healthcare degrees, or masters in science). According to past surveys (SOS, MSL Institute, Kupferer, 2009), the majority of MSLshold either a Pharm.D. or Ph.D., with a smaller percentage holding a MD. Although the trend is towards post graduate degrees, healthcare professionals without doctorates with industry experience in a given therapeutic area are often considered.
Retrieved on April 9th from http://www.etymonline.com/index.php?search=liaison&searchmode=none
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.
The MSL is a person who can communicate high scientific concepts, yet balance clinical objectives with business objectives. The MSL role can be difficult to navigate given that the FDA and OIG have established very little direct regulation that applies to the MSL.
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
Highlights from ExL Pharma's 6th MSL Best Practices
April 29-30, 2010<br />Arlington, VA<br />Highlights from ExLPharma’s 6th MSL Best Practices<br />
Defining the Role of the Medical Science Liaison<br />
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 />
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 />
Background<br /><ul><li>Nomenclature (varied)</li></ul>Medical Science Liaison <br /><ul><li>United States Patent and Trademark Office Serial #73176757 (1989)</li></ul>Medical Science Manager<br />Field Scientific Managers<br /><ul><li>Educational/professional diversity</li></ul>PharmD<br />PhD<br />MD/DVM<br />RN/NP/PA<br />Basic Science Degree/Researcher<br />
Etymology<br />Liaison:<br />Originated in 1640s<br />French: liaison "a union, a binding together," <br />Latin: ligationem "a binding,“ (ligament)<br />1806: Sense of "intimate relations"<br />1816: Military sense of "cooperation between branches, allies”<br />The noun meaning: "one who is concerned with liaison of units, etc."<br />Retrieved from Etymology online on April 9th from http://www.etymonline.com/index.php?search=liaison&searchmode=none<br />
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 />
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 />
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 />
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 />
Value Activities<br />KOL interactions/Conference attendance<br />Health Outcomes Research<br />Patient Advocacy/Community Education<br />Sales training<br />Speaker training<br />Disease state awareness/presentations<br />Risk evaluation and Mitigation Strategies (REM)<br />Involvement with Phase II-IV, Investigator Initiated Trials<br />
MSL Training/Continuing Education<br />Certification of knowledge of current products and therapeutic area<br />Pharmaceutical Detailers Licensing<br />Continuing education requirements and evaluation<br />
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 />Educational sessions/sharing of best practices<br />Research/surveys<br />Focus groups: licensure, certification<br />
Minimize Risk of Medical Science Liaison non-Compliance with Federal, State, and Industry Requirements<br />
MSL Marketing Consequences<br />Government: OIG, FDA, DoJ, State Attorneys General<br />Competitors: Lanham Act<br />Consumers: Product liability, Qui tam<br />
Specific 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 />
Specific Concerns<br />FDA<br />Notice of Violation<br />Warning Letter<br />Seizure<br />Civil and criminal penalties<br />
Specific Concerns<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 />
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 />
MSL, OTL, and HCPs<br />What are the risks?<br />
What do MSLs do?<br />Talk to doctors?<br />Recruit and retain OTLs?<br />Comply with legal, regulatory, and company requirements?<br />Competitive intelligence?<br />Take science to the world?<br />Deliver pizza and make copies?<br />
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 />
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 />
But What About OTLs?<br />They are tender and fragile and need constant MSL attention.<br />Your firm wants the OTLs to be good scientists who give good independent advice.<br />Don’t get your OTLs in trouble<br />Are you paying them reasonable fair market value?<br />Are you asking them to do to much?<br />You don’t want them to lose credibility.<br />
OTL Role?<br />Speaker’s bureau?<br />CME presenter?<br />Consultant?<br />Clinical trial investigator?<br />Investigator initiated study grant recipient?<br />
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 />
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 />
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 />
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 />
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 />
Conclusion<br />MSLs are very important for your products.<br />Healthcare provider education is critical.<br />Healthcare provider and industry relationships are under scrutiny from everyone.<br />Ask yourself, how does this look to an outsider?<br />
Want to attend next year’s conference? For additional information on ExLPharma’s MSL Best Practices Conferences, please visit www.exlpharma.com<br />