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
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
Highlights From 7th Medical Science Liaison/MSL Conference
Highlights from ExLPharma’s7th MSL Best Practices Forum<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 />2<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 />3<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 />8<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 />9<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 />10<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 />
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 />
MSL Marketing Consequences<br />Government: OIG, FDA, DoJ, State Attorneys General<br />Competitors: Lanham Act<br />Consumers: Product liability, Qui tam<br />
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 />
Specific Compliance Concerns cont.<br />FDA<br />Notice of Violation<br />Warning Letter<br />Seizure<br />Civil and criminal penalties<br />
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 />
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 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 />
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 />
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 />