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M. Obladen
Oct. 24th, 2018
MSL – Rolle und Trends
Medical Affairs profile: Key functions
2
COMMUNICATIONS / EDUCATION
• Medical information / requests / FAQs • KOL-management • Advisory boards etc. • Medical education • Expertise congresses • Presentations • Publications (organization etc.) • Scholarships • Support Brand Teams / Communications
MEDICAL GOVERNANCE
• Medical checks, releases • Internal medical support
DATA
• Early benefit assessment • Value Dossiers • Phase IIIb – IV • Treatment pathway • Healthcare research • Health economics
INTELLIGENCE
• Market observation • Analysis competing companies • Demand analyses
(primarily Unmet Medical Need) • Business development
MSLs – Purpose MSLs are a key interface with our customers
Spend the majority of time on customer-facing activities (mixture of field and HQ-based)
Primarily focused on KOL engagement, developing and strengthening peer-to-peer relationships, especially in support of new therapeutic areas / products (possibly extending to other customer groups)
Focus on scientific and medical information dissemination and exchange, leveraging innovative customer engagement tools (for both proactive discussions on-label, and reactive discussions for unsolicited off-label questions - where allowed)
Ensure close compliant collaboration between Medical Affairs and the Business Units, working together towards a common business strategy
Depending on country size and specific BU requirements, MSLs may serve internal customers (e.g., training) and support Investigators (e.g., ISS) as additional priorities
MSL Model - Objectives
Better service to our customers, providing high quality scientific exchanges regarding the latest medical information and a link to the broader R&D community
Empowering MSLs to address all customer questions in one go
Fosters a compliant, collaborative, goal-orientated working environment between Medical Affairs and BUs, aligned to and supporting the business strategy
Professionalization of a critical function (with a clearly defined career path) to deliver greater impact
Safeguarding of patient safety by distribution of fair and balanced information
Informed customer base and a supportive environment for Company’s TAs and products (particularly for launch brands)
Creates a platform to test, build and implement innovative customer-facing activities & tactics
Increases the credibility of our people and the scientific image of the Company
Key objectives of a MSL organisation
To develop concepts, coordinate & implement • medical – scientific communication • interactions & scientific activities with KOLs • other relevant stakeholders
in order to put a perspective on
• scientific opinion/data interpretation & therapeutic application • for the products of the Company’s portfolio & scientific context
To enable HCPs to make better decisions for their patients
Gain in depth market insights & understand trends
Support internal stakeholders & activities through top scientific contributions
Governance: Activities within Medical Affairs
Primary Activities: • Exchange and dissemination of scientific,
educational, and research related information using innovative KOL engagement tactics
– Both proactive discussions on-label, and reactive discussions for unsolicited off-label questions - where allowed - to generate acceptance
• Interactions with medical societies and advisory boards, congresses and conventions
• Speaker Development • Coordination of Scientific Education Activities • Preparing reports and tracking activities • Collecting ISS ideas and facilitating ISS set-up • Coordinated approach (with BUs) to KOL:
– Identification – Profiling / segmentation – Strategy and engagement planning
Representative Activities: • Managing publications • Organizing conferences and symposia • Preparing scientific content • Providing advice to commercial functions regarding
promotional materials • Signing off promotional material • Support to internal training • ISS execution and monitoring • Operational execution of development
activities • …
MSLs Office-based Medical Affairs
MSL – Organisation: key considerations
Competence
Service / Customer focus
Ambition
• Communication • Science • Interpersonal
• Externally • Internally
• Leadership – Accepted Scientific Partner / Best Practice
• Integrity / Credibility / Reliability • Flexibility • Efficiency / Target orientation
Scientific expert
Broad and balanced
Well connected Inter-personal skills
Areas of interest for Thought Leaders (TLs)
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TLs expressed strong interest for information about new indications / new products before launch because it can be very difficult to access otherwise
TLs value discussions on new topics (e.g., new indications, risks and interactions)
For TLs, the link into the R&D community provided by Medical Affairs (MA) seen as a great advantage
Access to information about future
launch products
Access to novel information about
approved products
Link to R&D community
Listening to stakeholders enables Pharma Cos to better interact with them
9
Stakeholders value an expert they can speak to as a peer, with a strong scientific background – often as the most valuable interface to a pharmaceutical company
TLs want a balanced and broad dialogue
TLs use and value MSLs as a key source of information and perspectives to form their opinions
TLs are being exposed to new engagement forms, however these cannot substitute for face-to-face meetings
What is the Value of MSL Teams?
Focus on customer-facing roles, particularly field-based MSLs
The Real Value of Medical Affairs
FirstWord Dossier. The Real Value of Medical Affairs. August 2016.
TL Identification, Segmentation and Engagement
Establish a meaningful dialogue, preferably face-to-face
Building Value Relationships Understand the TLs’ needs and provide
something of real value
Measuring Performance TL perception and use of insights to inform
future decisions
Organizational Change Medical-to-medical approach, coordinated,
seamless engagement strategy with Medical in the lead
Medical Affairs
The window of Launch Excellence is short & does not forgive any mistakes
12
Maximize Commercial
Potential
Foundation for Success
Accelerate Uptake
Development Pre-Launch Launch Growth Maturity
Optimize Profitability
& Extend
Brand Life
Maximize Peak Sales
Window of Launch Excellence
Mistakes at launch are expensive
(if not impossible) to correct
• Fewer than 25% of launches significantly improve on their six month trajectory by 2 years
• Priority is in identification and removal of access barriers
MSL – Continuum of Activities
KOL relationship management (Identify, interact and engage) Scientific exchange and education Respond to unsolicited off-label requests (KOLs other health care professionals) Interface with internal medical - scientific education (develop & deliver) Advisory boards Scientific symposia, congresses (MA booth) Research – phase III
Field intelligence / monitor trends/developments Slide development - disease state, formulary
Interact with cross functional partners - Sales, Marketing, other Grand rounds, round tables and journal clubs
Identify and interact with speakers (training) Formulary, HEOR, & Market Access scientific presentations
Issue management (safety, adverse events) Research – phase IV, ISSs, publications
Pre-Launch Post-Launch Launch
Industry Benchmarks – MSL Responsibilities
14 © COPYRIGHT 2014 CUTTING EDGE INFORMATION, LLC ALL RIGHTS RESERVED
Core responsibilities • Meeting face-to-face with TLs • Delivering scientific presentations/speeches • Identifying new TLs • Attending medical meetings and congresses • Supporting research (IIRs / Clinical Trials) • Continuing education/self-learning courses Secondary responsibilities • Collecting competitive intelligence • Meeting with internal stakeholders • Training speakers • Participating in advisory boards • Training new MSLs
56% 29%
12% 3%
Core Secondary
Occasional Rare
Average percentage of time spent on MSL Activities
Occasional responsibilities • Presenting to formulary committees • Training field sales forces • Evaluating clinical study sites • Contributing to health economic analyses
Industry insights Industry MSLs to meet with TLs only when there is something discuss. Without new information to discuss, TLs could construe the
meetings as commercial rather than scientific
Self-education consistently ranked as a core activity for MSLs. Medical meetings and congresses are viewed as key for networking and learning
TLs want MSLs to know about competitors, but keep balance and no bias in discussions.
Leading MSL teams are focusing more on identifying and building new relationships with non-traditional TL segments like Clinical TLs, networks
TL rating of MSLs’ as credible is an important measure of value to TLs. MSLs are viewed with a high rating credibility score
The ability to meet TLs needs right away makes TLs “Very Satisfied” – Customer Service This is listed as an area for improvement (MSLs in general - industry)
Meetings within a hospital are viewed as more effective and productive (More engaging conversations and more diverse group of stakeholders)
Activities Necessary to Ensure Top in Class
Dimensions for Measuring MSL Success
Cutting Edge 2014
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Thank you!
Thought Leader segmentation and tiering
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TIER 2 35 International TLs
TIER 3 National TLs
International Thought Leaders with global strategic influence
International Thought Leaders
National Thought Leaders, managed by country teams
TIER 1 15 Int TLs
with strategic impact
Stakeholder evaluation system
20 Source: Mederi
Development
Market Access
Commercialization
S M d i
Aggregation of all Role Scores
E.g. position in hospital or private practice
E.g., organizer/speaker/participant position, Press/Book/Editorial Board PositionScientif ic or Patient Association / Foundation
Author of Medical GuidelineGuideline Committee Position
Reimbursement / Pricing / Budget Committee Payer Positions; Governmental Advisor
Regulatory Institution (executive / legislative) Approval Advisor Positions
HTA Position, HTA report , Company Position Meta-Analysis, Comparative Analysis, Review
Clinical Trial Publication or PositionAdvisor Activities
E.g., Research Group or Institute PositionsGeneral Article or Positions
Advisor
Investigator
Researcher
Prescriber
Disease Advocate
Guideline Maker
Decider(Budget)
Decider(Approval)
Overall Score
Product Life Cycle Stakeholder Role Role Drivers
Thought Leader collaboration process
Martin Obladen October 2018 21
... on a yearly basis reflected in regular plans
TL Classification
TL Networking
analysis
TL Identification
revision
TL Identification
Product stage D 4 D 5
PoC D 6
Start IIb D 7
Start III D 8
Submission D 9
Launch Post-approval studies LCM planning
~ Timeline (months) -48 -24 -12 0 12+ 24+
TL status First identification Collaboration plan
Local alignment/ access plan
Optimize collaboration/ ISS guidance
Optimize collaboration/ ISS guidance
Advisory boards
HQs
Collaboration plan
Thought leader profiling / insights
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Regular assessment
Weekly report
Competetive events CME, monthly
Update on TL networks
Expert panels
Deep dive medical societies
Guideline assessment
Congress / stand alone reports
Screening literature
Specific projects e.g. surveys
Key elements for strategic TL management
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• Identification – Selection – Segmentation – Mapping of TLs – network analysis, applying objective criteria
• TL interaction plan/log – SINO
• Comply to Regulations & Compliances (e.g., FMV, Sunshine Act)
System / Platform Cross-functional Team
• Composition - Local – Regional – Global - MED – MKT – Sales – MACS – Advocacy
• Strategic input to the TL management
• Aggregate information to share status of TL management/engagement plan
KOL Engagement Plan & Execution
• Execution in Excellence in accordance to regulations and compliance (e.g. Medical Ad Board Meeting)
• Coordinated approach to TLs: System/Platform, TL manager/coordinator
Strategic and productive cross-functional planning/engagement Provide visibility/sharing across extended team
Execution with Excellence, complying to Regulations/Compliance
Thought leader identification and profiling process
MSL Xarelto®
25 Data source Thought Leader (TL) SINO data cut off 2018/01/03
Editorial Boards
Clinical Trials
Meetings Awards
Advisory Board Guidelines
Authors > 3 publications
Potential TL‘s
→ 1.525 Thought Leader
In cooperation with:
Global TL:
German TL:
Internal MSL check:
Buttom up MSL field check: