Funciones del MSL en su actividad diaria .

Beatriz Pérez Sanz MD.

Directora Medico Roche Farma
Who am I?

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hyperLink here

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A vision for Medical Affairs

“It’s not the strongest of the species that survives, nor

the most intelligent that survives. It is the one that is
most adaptable to change”
Charles Darwin

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Healthcare is advancing at a furious pace

5
 
High resolution view of each patient and
their disease

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Personomics should be the frame

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Nothing About Me
Without Me
 Best-in-class Medical engagement will look very
different from today

▰ Medical Credentials
Natural Owners
▰ Scientific Know-How
of the business
▰ Credibility among Stakeholders

Medical Affairs as a primary strategic pillar of the

organization 10
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The impact of MSLs

“ The best MSLs are the ones who

approach me as an individual, and find
out what is important to ME, what I
really need.
The impact of MSLs

“ At a congress presentation there isn’t much

discussion, or debate – I like MSLs to follow up
on-site so we can really discuss what the data
means.
 Stakeholders cite the need to obtain scientific
and clinical information from MSLs

In addition to providing up to date compound-related information,

stakeholders recognize the growing importance of MSLs

Would like MSLs to discuss data

71% from clinical trials & recently

published
journal articles

Would like MSLs to provide

66% updates from recent congresses
and symposias

Would like MSLs to respond to

58% specific unsolicited requests for

information
(e.g., off-label queries)
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 It is also vital for stakeholders to discuss data from
clinical trials and future collaboration opportunities
with MSLs

TAEs believe it is extremely important for MSLs

79% to provide information on emerging data for the

various marketed compounds

53%
TAEs believe it is extremely important for MSLs to
act as liaisons for clinical investigators

TAEs believe it is extremely important

48%
for MSLs to provide TAEs with access
to company resources by connecting
them to other stakeholders
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 MSLs are the scientific face of a company and play a
critical role in the field in order to bring distinctive
value to our stakeholders
WHAT is the MSL role?
MSLs are a key driver of knowledge exchange and collaboration with
healthcare professionals. Their non-promotional nature helps form peer-to-peer
level relationships with TAEs and physicians
WHO do MSLs engage with?
MSLs focus on Therapeutic Area Experts (TAEs), HCPs and clinical
investigators.
In addition, MSLs provide cross-functional support (e.g. market access, public
policy) to their company counterparts
HOW do MSLs address customer needs?
MSLs act as the interface in the field to exchange scientific information with
TAEs throughout the lifecycle. They have 4 main roles: Collaborate : Inspire
Medical Strategy, Exchange Scientific Ideas, Engage Investigators, Share
Insights
WHY is the MSL role valuable?
• MSLs establish themselves as clear, trusted and peer-
level counterparts with HCPs to discuss scientific and
medical matters
• MSLs provide up-to-date information / education on
latest scientific data and topics (e.g. new pathways, MoA,
new compounds) and in turn help advance patient care
• The credible and reliable information shared by MSLs
helps build trust and enhance the company’s image in
the eyes of the medical community
• The trust built upon by MSLs leads to several
opportunities for scientific collaboration with our
customers
• MSLs ensure providing premium customer experience
to Health Care Providers
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 The role of the MSL is vital for Scientific Exchange and
collaboration with healthcare professionals as well as with
internal functions

Scientific Exchange* is the non-promotional exchange of information

between a company, HCPs and the scientific community, focusing on
developments in medical research, the management of disease and the
appropriate use of our compounds in order to advance scientific understanding
and progress with the ultimate aim to enable best possible patient care

Scientific exchange conducted by MSLs can be initiated by them (proactively) or can be in

response to specific requests from TAEs (reactively). Local rules and regulations must be
followed.

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 There are certain key principles which guide MSL
engagements and ensure proper coverage of stakeholder
needs

 A trusted, peer-level partner for Scientific Exchange

 Non-promotional, unbranded and scientific in nature, factual, up-to-date, fair and balanced activities
and communications
 Off-label, pre-approval and disguised promotion is prohibited
 Distinction between MSL and Commercial at all times
 Activities and materials used shall always comply with applicable external and company internal rules,
regulations and policies

Key characteristics of MSL engagement

Scientific Maintaining peer to

Non-Promotional 18
Exchange peer relationships
 Quick guide before implementing MSL Scientific
Exchange

Does the activity have the risk of being perceived as promotional

and/or inappropriately induce the use, purchase, supply,
administration or prescription, by TAEs/HCPs?

Does the activity lack a clear medical or scientific purpose, able

to contribute to advancement of research, knowledge of the
medical community and/or better patient care?

Is the activity main purpose/goal to build, maintain or

strengthen a relationship?

If you answered YES to any of these questions, the

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activity must not be implemented
 In what phases of the lifecycle do MSLs have a
contribution?

MSLs add value throughout the lifecycle, pre- and post-approval.

Key driver High intensity support Low intensity support

Core Strategic Role Supporting Role

Years HCPs & TAEs Payors Patient groups
-4

-3
Early or
TAE profiling Support as questions arise
Development
Stage (e.g. pipeline, evolving science,
-2 disease education)

-1
Pivotal data readout

Launch
Increased need for collaboration and Key resource to Supportive role
+1 knowledge exchange with payors teams on: in:
Peri-launch healthcare professionals
+2 • Clinical data • Building/maintaining
collaboration
• Disease
+3 Reduce need over course education • Scientific
of compound’s lifecycle1 presentations to
+4 support patient
Flexible need based on access
+5 internal/external drivers Insights generation
Post-launch

+6 Remain main interface for niche indications,

rare disease, and selective MD segments Support as questions arise
+7
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1
Within an established Disease Area, new indications and new compounds contribute to steady-state MSL
intensity and staffing/activity
 MSLs gradually increase engagement over compound
lifecycle with transition to increased Sales Rep activity
post-launch

The reduction in MSL

activities after launch MSLs gradually reduce activity
differs for each affiliate over compound lifecycle

Increased need at least 2 yrs

pre-launch in new TAs or
complex disease areas Maintain or reactivate MSL
activities if new indications,
changing landscape,
MSL focus on Shift in MSL emphasis physicians preference, etc.
knowledge from “top-tier” TAEs to
exchange and regional peer-to-peer
Collaboration network leaders
with TAEs

-4 yrs
pre-launch Pivotal Launch Post-Launch
(development phase) data
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 To successfully perform activities and address
customer needs MSLs employ an optimum mix of
engagement channels

On label discussions Face to Face

Off label queries WHA
HOW Group setting
T
Disease area / TA Phone
discussion
MSL engagement E-mail
CSTs / IISs/ IITs with stakeholders
Virtual
compound / Pipeline Collaboration
discussion

WHERE
1:1 in meeting in office
Clinics / Hospitals
Clinical Trial Sites
Academic Institutions
Congresses / Summits 22
Advisory Boards
 Several key internal and external factors drive the
required intensity of MSL activity

Internal factors
• New Trial readout (e.g. positive or negative pivotal data)
• New safety information
• Disease Area or MOA that is evolving and highly complex
• High (scientific) differentiation between company’s compounds and other compounds

External factors
• New treatment options are approved and/or new data on available treatments becomes public
• Evolving regulatory/compliance landscape
• Changing payer requirements to more outcomes-based decisions (e.g. risk-sharing schemes /
scientific evidence or outcomes)
• Evolving Real World Evidence
• Need for disease education
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 MSLs play a critical role

MSLs are a key driver of knowledge exchange

and collaboration with healthcare professionals.

They are responsible for:

Exchanging i Engaging Sharing

i scientific ideas investigators i insights

Inspire medical strategy 24

Exchange Scientific Ideas – Overview

Information
Information sharing
sharing with
with HCPs
HCPs

Medical
Medical education
education

Congresses
Congresses and
and symposia,
symposia, Advisory
Advisory Boards
Boards

Medical
Medical Advisory
Advisory Boards
Boards

Support
Support for
for interactions
interactions with
with payors,
payors, patient
patient
groups and other stakeholders
groups and other stakeholders 25
 Information sharing with HCPs

Activities

• Answer unsolicited medical and scientific questions from any stakeholder (incl. TAEs and HCPs),
including off-label information and pre-approval
(also applies to standing requests)

• Provide HCPs with up-to-date safety-related information

• Engage in medical/scientific discussions with HCPs at scheduled events (e.g. investigator meetings, ad
boards, congresses, etc.)

• Inform on not yet approved line-extensions of already marketed drugs - information on these should not
be included at any company hosted/sponsored educational standalone events. This can however be done
when the event is a session part of a larger event, e.g. a congress or scientific conference

• Inform on company pipeline with no marketed drugs - if appropriately labeled, this can be done at a
company hosted/sponsored standalone educational events

• Provide safety updates and changes in package inserts and SmPC. New safety information
must be assessed under established drug safety procedures before it’s communicated.
Consultation with Drug Safety is needed to ensure information is approved for public disclosure.
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 MSLs are responsible for conducting both reactive and
proactive activities in order to address customer needs

Reactive Proactive

 MSL activity or information sharing which is initiated by an  MSL-initiated activity or information sharing which is not
unsolicited request on a specific topic based on a response to an unsolicited request

Examples of some Proactive activities :

Special case of a reactive activity :
 Standing request: A delayed answer
to an unsolicited request. A standing request needs to be specific
and recorded on file
 At the time of responding to a request, MSLs may ask the
requester if she/he would like to receive an updated response to
their inquiry should new information specifically responsive to
their inquiry become available within 6 months from their
original request
 Communication of safety updates and changes to the package
insert, e.g. concerning regulatory approval of a new indication
or information that changes the compound profile related to the
use of the compound
 Communications relating to a company scientific research
support and sponsored trials to actual or potential recipients or
investigators of such support

Scientific exchange conducted by MSLs can be initiated by them (proactively) or can be in

response to specific requests from TAEs (reactively). Local rules and regulations must be followed
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 Aspects to increase acceptance of proactive scientific
exchange containing off-label/pre-approval
information, in stricter environments:

1. Communication does not include outcome or therapeutic benefit data (e.g.: pipeline/research overview)

2. Information is already in public domain (e.g.: presented at congresses, scientific publications, published clinical trial

3. Information is presented in unmodified form (e.g.: original publications, as published)

4. The company is not covering costs for participation at company-initiated presentations

5. In some cases, an activity involving pre-approval information may be considered more acceptable than an activity involving off-label information (off-

label discussion could be considered more severe as it would be possible to actually use a product that is already on the market, in the off-label space)

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 Medical education

Educational activities directed at HCPs which serve to maintain, develop or increase the knowledge, skills and professional
performance for the ultimate benefit of patient care and outcomes

Activities

• Provide on-label medical information on request to investigators & TAEs with whom the company has a pre existing collaboration post approval
of a new compound/ indication and only as informational purposes

• Organize Company Initiated Medical Education (IME) – unbranded information on a company compounds (if any) stated within the context of
therapeutic area and on-label only

• Third Party Meeting: Medical Education Grants– organized by a third party and supported by a company on request

• Company Meeting within a specific Hospital unit (e.g. medical information on compound or unmet medical needs)

• Give a presentation about specific scientific topics to a group

• Conduct a company meeting on Disease Area or new MoA/pathway education (not compound-specific and no direct link to the compound pre-
launch)

• Discuss scientific topics with HCPs not directly associated to a specific compound (e.g. DA, clinical practice)
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 Initiated Medical Education (IME) organized by an
MSL
• Educational activity for HCPs initiated by a company or by a 3rd Party on a company behalf or where the company has
influence over the program (agenda, content, faculty).
Initiation of the meeting • Can be organized proactively by the MSL according to medical plan objectives

• Non-promotional
• Specific and objective,
Programme • Fair and balanced
• Unbranded information on a company compounds (if any) stated within the context of therapeutic area and on-label only

Audience • HCPs

• HCP(s)
• MSL and other company medical staff
Speakers • Other non-commercial speakers from the company (i.e. Legal). Needs to have a local approval process around the
company speakers’ selection

• Sales reps usually not allowed to attend due to pre-approval and/or off-label discussions that may arise*
Sales Reps
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Materials • Approved scientific slides with no promotional aspects (logo, claim, etc.)
 IME (Independent Medical Education)

• IME is educational activity for HCPs initiated and organized independently from the company by an
Initiation of the meeting IME provider (independent 3rd party) with a financial support by the company through a grant, and
where the company has no influence on the content of the program

Programme • The IME provider must have full control over the development and selection of all aspects of
activity; including content, speakers/presenters, moderators and audience

Audience • HCPs
• HCP(s)
Speakers • MSLs can not be speakers.
• The company employees must not suggest or select speakers, even if requested by the IME provider.

• Only limited number of the company staff may attend IME events that are funded or partly funded by
a company grant as «silent observers» for their own education.
Attendees • Company attendees must declare their affiliation in the registration

Materials provided • The company must not provide any materials

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 Congresses and symposia

Activities
Attend congresses and symposia:

• Provide briefing to speakers on the scientific background for the presentation (e.g. promotional
speakers or internal clinical trainers) on the development of materials

• Inform HCPs / TAEs of dates of upcoming scientific events

• Stay up to date with information from medical congresses and symposia – All material
needs to be locally approved before being used

Post Congress Scientific Exchange:

Educational activity that takes place following a congress to inform the broader audience of
HCPs about information presented at a congress. The aim is to provide in-depth information on
advances in science

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 Medical Advisory Boards

Activities
• Affiliate-level Ad Boards can be initiated by CMMs; territory (local)-level Ad
Boards can be initiated by MSLs

• Clinical/scientific information can only be presented by medical/scientific

personnel including MSLs

• The sole focus of the Ad Board meeting is to solicit advice, not to

promote compounds or to compensate members for other purposes

• Regulatory requirements of the country where the Ad Board is held must

be followed

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 Medical advisory board meetings

• Ad Boards are established to seek input, advice or feedback on issues and strategies, for example protocol development, compound safety review,
Purpose compound development strategies and medical strategies
• Ad Boards must not be used to promote the company compounds or to compensate the Ad Board members for other purposes.

• The organizer must complete the iHCP request form and submit it for approval to the Affiliate Contact from the country where the HCP practices
• Affiliate-level Ad Boards can be initiated by CMMs; territory (local)-level Ad Boards can be initiated
by MSLs
• Commercial advisory boards must be driven by sales and marketing.

Ad Board setup/
• The sole focus of the Ad Board meeting is to solicit advice, not to promote company compounds or to compensate members for other purposes
initiation process • The organizer must maintain records of the services provided by Ad Board members
• The organizer must ensure a written contract including confidentiality and intellectual property clauses
is signed and provided to the company prior to commencement of any services
• Regulatory requirements of the country where the Ad Board is held must be followed

• The number of advisors should be kept to a minimum (max 20 advisors)

• Advisory board members should be selected based on their qualifications and expertise
Advisor selection
guidelines • Ad Board participation should not affect the way members prescribe, supply, administer, purchase or recommend compounds
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 Medical advisory board meetings

• Clinical/scientific information can only be presented by medical/scientific personnel including MSLs

• The attendance of personnel must be limited to those needed to achieve meeting objectives
Attendance • Marketing personnel (e.g. compound managers) may attend medical AdBoards but may not be involved in presenting clinical or
scientific information about the company compounds
• Marketing personnel may be needed in a non-promotional manner present sales analyses, market dynamics, messages or
promotional concepts required to obtain advice
• AdBoard meeting venues must be suitable (see “Hospitality and Venue Selection Guideline”)
Venue and
hospitality • Hospitality in connection with the Advisory Board must be limited to travel, accommodation and meals. No gifts of any kind may
guidelines be provided to AdBoard members

• Information presented to AdBoard members should be objective and necessary for them to provide the informed advice sought
Information
presented to • The materials used during the AdBoard must be in line with the company guidance
AdBoard • Off-label information can only be provided to the extent allowed under applicable local laws, regulations and industry codes; and it
members is necessary to obtain the requested feedback

The relevant documents must be stored depending on country regulation

Archiving
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 Support for interactions with payors,
patient groups and other stakeholders

Activities

Payors
• Attend payor discussions and provide scientific support to the Market Access team during these discussions
(e.g. on MOD/MOA)
• Provide input into the medical value proposition the CMM on a regional level and a national level

Patient Advocacy Groups (PAG)

• Help prepare/ present educational events/presentations with patients associations on DA or disease specific
topics
• Support Patient Advocacy Groups (PAG) Ad Boards on medical and scientific/clinical topics
• Provide medical presentations to Public Affairs
• Support Public Affairs/ Policy team and provide presentations of medical information to patients advocacy
groups (only on TA or compound information, non-promotional)

Others
• Play a supporting role in preparing medical presentations
to other stakeholders (regulatory bodies, insurance companies etc.)
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 Engage Investigators - Overview

Value
Value added
added by
by MSLs
MSLs in
in engaging
engaging investigators
investigators

Overview
Overview of
of trial
trial types
types

MSL
MSL role
role in
in sponsored
sponsored studies
studies

MSL
MSL role
role in
in IIS
IIS

MSL
MSL role
role in
in NIS
NIS and
and RWD
RWD

Process
Process to
to set
set up
up MSL
MSL support
support for
for aa trial
trial
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 Engaging investigators

Overall Benefits

 Improved site identification/selection and better patient

recruitment/retention strategies

 Continued development of a longitudinal relationship between

company and the site

 Ongoing collaboration and tactical issue management support

 Active demonstration of company’s commitment to clinical trial

support, increasing the chances of future trials 38
 Information sharing with HCPs
Benefits for Investigators
 Have a clearly identified credible and trusted
partner for scientific collaboration
 Streamlined communication and issue resolution
despite the company’s internal complexity
 Identify opportunities for collaboration
 Provide timely answers to investigators’ questions
about the compound
Benefits for Study Teams
 Opportunity to develop expert mapping early in the
process
 Support available to profile physician practices,
needs and perspectives, including views of new
data and competitive compounds/clinical studies
 Determine physician interest in ongoing research
and educational events
 Access to real-time insights from the field, in
particular on NMEs
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MSLs can contribute to clinical trials in a role that
is distinct from clinical operations

Build/strengthen collaboration with investigators and

TAEs

Improve launch strategy and preparedness through

direct real-life insights from investigators and experts

Improve TAE profiling and understanding

Distinct role vs. Monitors

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 Share Insights – Overview

What
What are
are insights?
insights?

Stakeholder
Stakeholder mapping
mapping and
and profiling
profiling

Advice
Advice seeking
seeking

Knowledge
Knowledge management;
management; Medical
Medical Training
Training

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 It is important for MSLs to discover insights

What are Medical Insights? It is important for Insights to be:

• Any information, provided in a well-defined context, which a  Not simply a collection of numbers
subject matter expert has identified as having value in decision-
making or that will otherwise enhance the knowledge base of  Corroborated and validated if anecdotal information
stakeholders
 Clear and concrete with rationale as to why they are considered an
• Medical information from the external environment or customer
insight
that is either novel or confirmatory
o Bears clear relevance to areas of strategic priority  Relevant
o Enables or expedites informed decisions on downstream actions at the  Sourced appropriately
level of the medical strategy and/or medical activities

• Includes diverse information (data, facts, and observations) that  Timely

helps understand the dynamic health care environment that
guide strategies and activities
In some cases the insights may not seem as “insights” until they are
aggregated internally. Thus it is important for the individual MSL to still
keep track of all of this information (not just what they consider
“insights”)
e.g., regional differences often show up as information kept by individual MSLs but only show up as insights when
viewed in aggregate 42
 Medical Insights Generation and Utilization

Relevant Insights can be Proactive or Responsive

Seek advice to generate insights by:
• Organizing and attending Advisory Boards
• Having informal conversations with HCPs
• Utilizing contracted consultants
• Obtaining input from TAEs

Relevant Insights Contribute to Strategic Planning

Provide global and local support for the
development of:
• Medical strategy and medical plan
• Overall brand strategies

Relevant Insights Enable Knowledge Management

Provide therapeutic and scientific expertise to:
• Exchange best practices and knowledge
• Provide training and support to internal staff
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 Stakeholder profiling and mapping

Activities

• Mapping or identification of TAEs and centers

– Validate various sources of TAE lists to ensure accuracy and utility for medical planning
– Segment by various attributes to allow strategic selection of TAEs for consultation and partnership

• Profile physician's practices, needs, preferences and views of new data:

– Determine physician interest in ongoing research and events
– Obtain physician perspectives on evolutions in the disease / patients unmet medical needs treatment algorithms

• Identify opportunities for collaborations between the company and TAEs

– Identify TAEs for local HTA interactions by evaluating HCP expertise, ability and/or interest in working as a
partner/service provider, other than regarding their interest in serving as a promotional speaker (TAE profiling)

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 The customers engaged with by MSLs are also
interacted with by various external (competitor) and
internal teams
External Internal

Regulators MSLs

Guidelines Tier 1 Development

Committees (50-150)

Competitors Affiliate MDs

Tier 2
(National)
Payers Global
Tier 3
(Regional) Marketing

Tier 4
(Local)

It is essential that MSLs collaborate with the various internal teams in order to provide
best-in-class customer experience to our customers 45
 Evolving healthcare dynamics are challenging traditional
tiered engagement approaches, leading to a widening
stakeholder audiences

Traditional TAE Customer

Evolving TAE Customer Model
Model
Customer Universe
Increasing Size of

Caregiver Physician Group

T1 Professional
H Societies

T2 Treatment
ACO Team Institution

Payer Policy Maker

T3
Consumer Patient
Rights Orgs
Media
HCP
HCPs
Widening Customer Base

With the increase in customer types, it is all the more essential for MSL teams to accurately identify and
profile their customers in order to address customer needs 46
 Identification and mapping of these stakeholders is a
complex exercise with several key inputs required to The process for TAE identification
entails Identifying, validating TAEs
drive the process from all relevant geographies and
building out detailed influence maps
of each TAE based on their
Some key metrics for TAE Identification and
involvement in journal publications,
Mapping congresses, clinical trials and various
Have some level Publicatio affiliations
of influence in Greater the number of publications,
n counts
the scientific more influential is the TAE
community and types
Reverse Greater the number of reverse Are looked up to
citation citations, by other
physicians in the
Possess unique
counts more influential is the TAE community
credibility
stemming from Clinical Participation in authoring clinical
years of industry guidelines guidelines increases TAE influence
experience
Clinical Willingness to
trial Participation in clinical trials engage in
Investigato increase TAE influence scientific
engagements
rs

47
Denotes TAE Characteristics
 Advice seeking

Activities

1. Knowledge Management

• Ensure exchange of best practices and knowledge creation between affiliates*

• Help in their affiliate to prepare materials and provide information for local knowledge exchange activities, including supporting the
preparation of presentations and scientific papers in their therapeutic area (primarily handled by Medical)

2. Medical Training
• Provide therapeutic/scientific training and support to internal local staff *
– On Disease Area (e.g. treatment guidelines)
– On compound (e.g. MOA)

48
 In addition to addressing customer needs, MSLs bring
substantial value to internal stakeholders both at
global and local levels
Global / corporate Regions & affiliates

• More effective knowledge exchange and • Improved awareness and

collaboration with international top-tier TAEs understanding of TAEs of the
Exchange
Exchange company molecules
Scientific
Scientific • TAE collaboration addresses
Ideas
Ideas growing need and desire for
scientific discussions

• Optimized CT execution resulting in • Improved launch strategy

accelerated compound registration and through direct real-life insights
reduced study costs
Engage
Engage • Stronger collaboration with TAE
Investigato
Investigato investigators
rs
rs • Optimized CT execution resulting
in accelerated compound launch
• Real-life insights feeding into strategy e.g. • Improved TAE profiling
– Clinical practice and treatment paradigm • Identification of new
– Data gaps, HCP preferences and needs opportunities to collaborate with
external stakeholders
Share – TAEs’ views on emerging data and
Share strength of clinical profile • Enriched/strengthened regional
Insights
Insights • Insights to Clinical Development organization and local medical plans
on shaping molecule development strategy (e.g.
Integrated Strategy Plan and Integrated
Evidence Plan) 49
Inspire Medical Strategy – Overview

MSL
MSLcontribution
contribution to
to Medical
Medical strategy
strategy

Interfaces
Interfaces with
with internal
internal stakeholders
stakeholders

Collaboration
Collaboration with
with Market
MarketAccess
Access

Collaboration
Collaboration with
with Patient
Patient Groups
Groups and
and
Organizations
Organizations

Collaboration
Collaboration with
with Country
Country Medical
Medical Manager
Manager

Collaboration
Collaboration with
with Medical
Medical information
information

Collaboration
Collaboration with
with Clinical
Clinical Operations
Operations and
and
Research
Research Teams
Teams

Compliant
Compliant collaboration
collaboration with
with Sales
Sales Teams
Teams
50
 Interfaces with internal stakeholders

MSLs engage with customers and bring in important information to the organisation. Collaboration
and coordination with internal colleagues may uncover new opportunities and new ideas that can
advance and transform clinical practice

Market Access Med Information

 Support Market Access teams by  Enhancing Customer
engagements with payers, Experience and streamlining
involvement in early access the flow of information
programs
Patient Groups and Organizations Clinical Operations and Research
  Better understanding of Clinical
Provide significant support to patient
groups manager and meeting requests
MSL Trial design and improve TAE
profiling

Country Medical Manager Sales Team

 Help in creation of feasible plans to  Compliantly exchange high
improve MSL-CMM relationship quality Scientific Information
and implementation of the same being delivered

Exchange of scientific ideas, engaging investigators, sharing insights drive collaboration across MSLs and their internal as well 51
as external stakeholders
 Collaboration with Market Access

• MSLs are actively involved in public and private payer meetings and provide
scientific support to payers as part of the formal review process of our reimbursement
Engagements with dossiers
Payers • Positive reimbursement decisions with the public payers is critical for optimal patient
access. These payers have the flexibility to consider data outside of the label.

Involvement in Early
Access programs • MSLs may also be involved in Pre- Approval or Early Access Programs,
where they explain the rationale of the program and eligibility criteria.

Contribution in • Real World Evidence programs also benefit from the involvement of MSL in
contributing to the identification of registries, protocol design as well from the
RWE programs
identification of researchers

Catering to needs of • MSLs present the clinical trial data from the submitted dossier that is being
other external considered to the HTA body. In some instances, MSLs identify and work with
HCPs who have been asked to present in payer meetings on our drugs
stakeholders 52
 An example

Where
“
MSLs supported and attended
>10 ocrelizumab private payer
meetings. The team developed a
document to track questions
raised during the meetings and
shared key insights post each
meeting in order to prepare for
future meetings throughout the
year. MSLs also worked closely
When 2017 with an HCP in one situation
where the payer requested an
external HCP presentation. HCP
preparation and support by the
MSL led to a successful scientific
exchange meeting
Drug “
53
 Collaboration with Patient Groups and
Organizations

“
Doctor
Targeting
Providing significant support to the Patient Groups
Information MSLs in collaboration with Patient
Manager, in close partnership with country medical
managers Liaison Managers supported the education
of patients, HCPs, nurses and general
society on a specific compound clinical
trials results, clinical trials benefit and on
Supporting meeting requests from patient groups to the need for clinical development. Another
Doctor Access
discuss scientific information on our molecules - initiative involved providing personalized
Information
particularly during the compound peri-launch phase medical education to patients in order to
identify key educational gaps and align on
the team / compound strategy. A
combination of channels were used to “
maximize impact
• All content for these meetings is reviewed and approved
by Medical Strategy
• In some countries, there are strict regulations that do not
allow direct to consumer advertising and therefore the
rigor around content reviews and approvals is important
54
 Strong collaboration with CMM

 The  involvement of the MSL in the co-creation of the

medical plan ensures that key critical field information is
Creation of Feasible plans incorporated and that the definition of the objectives allows
for the design of an aligned, realistic and feasible field
engagement plan. 

 The MSL – CMM is a vital partnership. MSLs are the eyes and

Optimal Implementation ears of the MM in the field. By working together, they ensure
optimal implementation of the medical plan. 

 CMMs have a strategic focus and MSLs can bring critical

Strategy Refinement medical insights from field that can help refine and shape the
medical strategy and maximize its success

 Open, frequent, rich and detailed communication with the MMS allows to
Development of future
unleash opportunities within the medical plan that will ultimately transform
opportunities clinical practice and benefit patients
55
 Collaboration with Medical information

Enhancing Customer experience

• The collaboration between MSLs and MI builds a more complete and robust
customer experience by allowing for higher quality of information service.

• Global Standard Responses allows the MSLs to provide accurate and timely
information to HCPs that has been referenced, reviewed and approved by MI

Streamlining Information Flow

• MI colleagues provide additional research to MSLs when needed to compliantly fulfill an
information request and also by document such information requests in the MI databases
• The close partnership allows information to flow within the local teams
and across different levels of the organization, and thanks to the continued documentation
of customers inquiries it's possible to analyze trends globally, that can later lead to enabling
of new activities locally, in field

56
 Collaboration with Clinical Operations and
Research Teams

 The interaction of the MSLs with the site begins at the time of the site initiation visit. At this time, the MSL
Enabling a better
presents the scientific rationale for the study and discusses the eligibility criteria and study procedures in detail
understanding
Doctor of the with the principal investigator (PI)
scientific
Targetingbackground
Informationand  The degree of study awareness among sub-investigators is variable at most centers. The MSLs also meet with the
clinical trial design site’s sub-investigators to help maintain focus on the study’s overall design, rationale and eligibility criteria.

Providing feedback from  Any feedback from the PI is provided back to the study team quickly. Once the trial is active and throughout the
Doctor Access course of the trial, the MSLs works with the PI to be certain that current information is available on the molecule’s
PI’s and identifying areas
Information development and to engage the PI in discussions on the study as well as on potential other areas for development.
for development

Improving TAE profiling and  MSLs provide a longer term benefit for the organization due to their acquired knowledge to help identify and
profile investigators and sites that are more likely to effectively perform on future clinical trials.
understanding

 MSLs serve as an interactive point of contact for the site, responds to requests and serves as a liaison between the
trial monitor and the site when potential performance issues are identified.
Acting as the point of
 MSLs work with all the sites on a trial to ensure that all investigators and study staff are fully engaged throughout
contact the course of the trial. In contrast to the clinical research associate (CRA), usually is working on a single study, the
MSL serves as the consistent face of the company across multiple trials 57
 Compliant collaboration with Sales Teams

• MSLs serve as an interactive point of contact for the site, responds to requests and serves as a
liaison between the trial monitor and the site.
MSL role
• MSLs work with all the sites on a trial to ensure that all investigators and study staff are fully
engaged throughout the course of the trial.

• MSLs derive their value by providing high quality scientific information. Any behavior that is
perceived by HCPs as promotional can harm the medium to long term strategy of the organization.
Information
shared • Many of the MSL engagements are scheduled by the HCPs, in direct dependence with their
agendas. Communication with field roles is crucial to allow for an optimal distribution of field
resources and to enhance team work.

• By compliantly exchanging daily information about what is happening with our customers we can
synergistically leverage efforts and achieve our common goal of delivering excellent customer
Impact of experience 
collaboration
• These medical insights when fed back to the organization they shape the medical strategy and the
clinical research programs, hence shaping the value proposition of the drug and its positioning.

• MSLs are not authorized to promote. Promotion requires a set of competencies and checks that
highly trained sales teams are able to perform compliantly.
Compliance • There should be no barriers to communication between colleagues in the organization, because
requirements, if any barriers of communication internally will ultimately show up in the face of the customer. Each role
should abide to their responsibilities and act in accordance with compliance requirements and
firewalls in order to avoid distortion or unwanted influence.
58
 Territory medical plan

Objectives

aa Guide local implementation of affiliate Medical Plan

bb Ensure strategic alignment and consistency across MSL teams

cc Monitor MSL activities and priorities

Guiding principles

aa TMP developed per DA, per MSL

Cross-functional communication and transparency (within medical

bb & relevant core head office team)

cc Territory specific information to be leveraged in TMP development

59
 Creating your Territory Plan : Where the
Integrated Plan meets your Territory Analysis

Territory
Integrated
Plan Situation
Integrated Plan
Medical Objectives
Analysis
There will be a lot of Key Issues
1... 1...
cross over between
2... 2...
Your territory analysis will Integrated Plan
provide you with
3... 3...
Medical Objectives Some of your territory
information to help you etc etc
and key issues key issues will not align
know which medical
to integrated strategy
objectives to prioritise
and so will be de-
prioritised

60
 Creating your Territory Plan : Where the
Integrated Plan meets your Territory Analysis

 The focus on the patient journey provides links between

the medical, commercial and market access plans
Integrated
Strategy  Insights generated from field medical can highlight
challenges and opportunities

+ + +  Ensures consistency between medical and brand

Commercial planning at appropriate points
Market access Medical section
section
 It creates value for clinical practice and can improve
patient outcomes

TMPs  Helps fuel efficiency of effort across the organisation

61
 Where the Integrated Plan meets your
Territory Analysis

When you find consistency between Integrated Plan Medical

Objectives and your own Key Issues, you should prioritise these
and work them up into tactics to go into your territory plan

62
TMP Planning Methodology

Review
Integrated Plan Situational
Medical Analysis
Objectives

Refer back to
Medical
Objectives
Territory Plan

Stakeholder Prioritise
Analysis Objectives
63
 Integrated Planning Requires Alignment of
Goals

Approaching your planning with a single patient focus

– moving from a strong data argument to patient
focused discussion – will enable you to broaden your
Brand discussions, your networks and the scope of your
Strategy / territory plan!
Company
Goals Engage your TAEs in the planning when it is
appropriate – and don’t only talk about one thing,
talk about the longer term too
Medical
Strategy / TAE / HCP
If you can include external stakeholder needs in
MSL Goals Stakeholder
your planning then you will find it more easy to
Goals deliver your tactical plans
64
 Structure of a Territory Medical Plan in a
Therapeutic Area

11 Territory situation analysis (year N)

1. Regional landscape
2. Key centers -Current standards of care including treatment guidelines
3. TAEs analysis
4. Activity analysis (Quantitative / Qualitative)
4.1. Clinical studies (Sponsor, relevant non-sponsor trials )
4.2. Medical partnerships (IISs, NIS, RWD..)
4.3. Scientific communication - Knowledge exchange
4.4. Other medical activities
5. Gaps analysis

22 Territory Medical Tactical Plan ( year N+1)

1. Key Medical Objectives :
1.1. Local Integrated Plan activity overview
1.2. Tactics according to Territory Specificities
1.3. Gaps analysis
2. New Clinical studies / medical collaboration
3. TAE profiling activities
4. Scientific communication – Knowledge exchange
5. Budget 65
2 ▰
Territory Medical
▰ Territory
Territory Tactical
Medical
Medical Plan
Tactical
Tactical Plan(year
Plan N+1 N+1)
N+1 Exa
in t mple
he s
Local loc umma
Local Integrated
Integrated Plan
Plan activity
activity overview
overview al I
nte ry pro
gra v
ted ided
Educational modules Medical Q&A Pla
n
Internal
Activities MSL leadership MSL leadership MSL leadership
meeting meeting #2 meeting #3

National and Regional Scientific Conference Coverage

Scientific Post congress update
Share clinical data Medical education Program
communic (slide deck) with Investigators
(slide deck) with Investigators
ation
Global Ed as relevant for that clinical
Unsolicited Requests Slide Deck trial

TAE Profiling, Mapping

Insights and site ID
Reg AdBoard Clinical Practice survey

Q Q Q Q Q Q Q Q Q Q Q Q Q Q
2015 2016

Clinical Clinical trial I

trial Data Readout
support Clinical trial II
Clinical trial III
Data Readout
Other ( IISs, RWD..)

Proactive Reactive
LIFE POST COVID-19

67
 Creative thinking
The illiterate of 21st century will not be
those who cannot read or write but those
who cannot learn, unlearn and relearn

Alvin Toffler

68
69
70
Lo que hacemos en nuestro dia a dia no se mide en KPIs

Se mide en VIDA
Advancing MSLs

72
¡MUCHAS GRACIAS
POR SU ATENCIÓN!
74