APRIL 29-30 , 2010ARLINGTON, VA

Highlights from ExL Pharma’s 6th MSL Best

Practices

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.

Defining the Role of the Medical Science Liaison

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

Need for MSL Role

Decreased access to thought leadersPhysician Payment Sunshine ActDecreasing Medical Education GrantsIncreasing complexity of products/devicesAdvocacy

Background

Nomenclature (varied) Medical Science Liaison

United States Patent and Trademark Office Serial #73176757 (1989)

Medical Science Manager Field Scientific Managers

Educational/professional diversity PharmD PhD MD/DVM RN/NP/PA Basic Science Degree/Researcher

Etymology

Liaison: Originated in 1640s

French: 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

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Thought LeadersHealth Care Providers

Medical AffairsCross Functional

PartnersClinical Research

Medical Science Liaison

Patient Outcomes

MSL Balancing Act

High level communicati

on of Scientific

information

Business acumen

Compliance

External Customers

Key Opinion LeadersLocal, regional thought leadersInsurance/Managed Care/PBMsHealth Care ProvidersAdvocacy groupsCommunity organizationsPatients

Internal Customers

Business Units/Sales MarketingManaged MarketsRegulatoryClinical Research/DevelopmentMedical Affairs Local/GlobalMedical information/communicationCompliance

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 AffairsNumber of MSLs should reflect the defined

role within the organization

MSL Characteristics

Solid Scientific backgroundAdvanced DegreeSelf motivated

Cutting edge current knowledge in therapeutic area Stays up to date on all research related to therapeutic area

productsPersonable/Flexible

Able to easily interact with individuals with varied backgrounds

Able to handle urgent business/clinical issuesEnjoys scientific exchange with KOLsMaintains relationships with KOLs

2009 MSL Survey Data Demographics

14

17%

69%

8%

5%

EducationGraduate degree (MS, MSN)Postgraduate degree (MD, PharmD, DVM, PhD)Undergraduate degree (BS, BSN)Other

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

Key Areas of Value

Maintain current/cutting edge knowledge within therapeutic area

Create and maintain science based relationships

Provide accessibility to KOLReciprocal relationships/perceived value to

KOLPerceived as field based Medical ExpertsNon-promotional/unbiased

Value Activities

KOL 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

MSL Training/Continuing Education

Certification of knowledge of current products and therapeutic area

Pharmaceutical Detailers LicensingContinuing education requirements and

evaluation

Summary

MSL role is varied based on Therapeutic area Company

Similarities High level scientific exchange Non-promotional Reporting structure/credentials

Future Educational sessions/sharing of best practices Research/surveys Focus groups: licensure, certification

Minimize Risk of Medical Science Liaison non-Compliance with Federal, State, and

Industry Requirements

MSL Marketing Consequences

Government: OIG, FDA, DoJ, State Attorneys General

Competitors: Lanham ActConsumers: Product liability, Qui tam

Specific 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 Concerns

FDA Notice of Violation Warning Letter Seizure Civil and criminal penalties

Specific Concerns

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, OTL, and HCPs

What are the risks?

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?

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.

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 trouble

Are you paying them reasonable fair market value? Are you asking them to do to much?

You don’t want them to lose credibility.

OTL Role?

Speaker’s bureau?CME presenter?Consultant?Clinical trial investigator?Investigator initiated study grant recipient?

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?

Conclusion

MSLs 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?

Want to attend next year’s conference?

For additional information on ExL Pharma’s MSL Best Practices

Conferences, please visit www.exlpharma.com