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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)

8

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

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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

23

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: