Highlights From 7th Medical Science Liaison/MSL Conference

Highlights from ExL Pharma’s 7th MSL Best Practices Forum

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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

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Need for MSL Role

• Decreased access to thought leaders• Physician Payment Sunshine Act• Decreasing Medical Education Grants• Increasing complexity of products/devices• Advocacy

Responsibilities of an MSL

Int/Ext Committees

Managed Care

Medical Meetings

Internal Meetings

InvestigatorsProjects

Networking

TL & Institutions

HCPs

Travel

Reports

Literature Keep-upFollow-up

Conference Calls

E-mails, etc.

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Thought LeadersHealth Care Providers

Medical AffairsCross Functional Partners

Clinical Research

Medical Science Liaison

Patient Outcomes

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External Customers

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

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Internal Customers

• Business Units/Sales • Marketing• Managed Markets• Regulatory• Clinical Research/Development• Medical Affairs Local/Global• Medical information/communication• Compliance

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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

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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

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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

2009 MSL Survey Data Demographics

14Kupferer, E. (2009) Medical Science Liaison (MSL) Medical Science Liaison Recruitment and Retention. MSL Quarterly, November 2009, ISSN 1547-7886.

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

MSL Marketing Consequences

• Government: OIG, FDA, DoJ, State Attorneys General

• Competitors: Lanham Act• Consumers: Product liability, Qui tam

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!

Specific Compliance Concerns cont.

• FDA– Notice of Violation– Warning Letter– Seizure– Civil and criminal penalties

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?

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.

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.

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.

Practical Ideas - SOPs

• Do your MSLs have SOPs, and are they trained?– off label discussions?– CME?– Interaction with sales force?

Practical Ideas - Reporting

• Does “S” stand for Science or Sales?– Who manages the MSL day to day operations, and

over-all strategy?

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?

Practical Ideas – New Products

• Do MSLs talk about products in development?• What level of involvement for they have in

investigator initiated studies?

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?

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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