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Highlights from ExL Pharma's 6th MSL Best Practices
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Transcript of Highlights from ExL Pharma's 6th MSL Best Practices
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
8
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