1

Medical Affairs Launch Excellence
Best Practices for Medical Affairs

Ramin Farhood, PharmD, MBA
Vice President, Head of Global Medical Affairs, AveXis
Greg Keenan, MD
Former Vice President, Medical Affairs and US Head Medical Officer,
AstraZeneca
Tricia L. Gooljarsingh, PhD, CMPP
Senior Director, Ironwood Pharmaceuticals
Meg Heim, RN, MAS
Vice President, Head of North America DCV Scientific
Communications, NA DCV Medical Affairs, Sanofi
Lobna Salem, MD, MBA
Chief Medical Officer, Developed Markets, Upjohn Pfizer
Paul Tebbey, PhD, MBA
Therapeutic Area Head, US Oncology Medical Affairs, AbbVie
Anna Walz
CEO and Founder, MedEvoke

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Medical Affairs

MedicalLeaderMedicalAuthority

Business
Partner

Strategist

Communicator

1. INTRODUCTION
The role of Medical Affairs within the healthcare landscapehas clearly evolved over the last 20 years, to its present
incarnation as an integral part of today’s digital healthlandscape. In today’s market, working with Medical Affairs is
no longer just an option, but essential for ensuring success infostering development in pre-launch preparation; perilaunch,
to develop one coherent voice with multiple internal andexternal stakeholders across channels; and postlaunch, foreffective maintenance of the portfolio, and continued growth.

“

The biggest change in Medical Affairs in
the last 10 years is that we now have a seatat the table as strategists. We are in less of
a supportive role. Now we are seen in aproactive strategic position. Medical Affairs
has always had external experiences dealing
with clinical trials and patients. Now, we candrive decision-making actions by bringing
information from external sources into thecompany to generate strategy.

”

Where Medical Affairs may have served in a scientificsupport role in years past, now it is one of the key drivers
Ramin Farhood, PharmD, MBA VP,
of all efforts, positioned at the nexus of Regulatory, Clinical,
Head of Global Medical Affairs, AveXis
Market Access, and Commercial needs, as a bridge to all andas a strategic partner with Commercial. This has occurred inlarge part because the days of successfully launching a new
product based solely on making it available through regulatory approval and marketing efforts no longer exists.
That approach is no longer feasible due to the increasing complexity of the changing healthcare landscape,considering key decision-maker needs and the evolving demands of patients, payers, and healthcare providers(HCPs).
So, let’s review the traditional role of Medical Affairs and the expanded role of Medical Affairs as it exists today.
In the past, Medical Affairs has historically worked in collaboration with pharmaceutical, biotech, and medical
device companies to:• Provide feedback on protocols for investigational drugs or new indications of approved drugs• Disseminate data and knowledge from clinical trials• Develop relationships with external stakeholders

While these areas of influence still exist, the role of Medical Affairs has evolved from a support role to that ofprincipal driver, collaborating with internal stakeholders (global corporate colleagues and associates) helping toaffect decision making. External stakeholders (such as external experts, medical and professional organizations,
physicians, patients, caregivers, managed care affiliates, advocacy groups, payers, social media influencers,
and policy makers) have set increasingly higher bars for the levels of scientific evidence needed to support a
product’s value proposition prior to launch. Medical Affairs has addressed this change in an ever increasingly
restrictive healthcare market. For that, in addition to understanding the disease area, an in-depth understandingof healthcare systems, as well as both internal and external stakeholder requirements, is key.1

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Previously, conventional commercial approaches focused on demonstrating a differentiated value proposition,
while targeting HCPs and patients as applicable, Medical Affairs mainly supported product registration, launch
activities, and inline marketing efforts. Supporting these activities required strong medical expertise and ability tointerpret and communicate clinical data to a targeted healthcare community; however, Medical Affairs provided
limited input on strategy.
Notable changes have impacted the healthcare system resulting in a need for more sophisticated approaches
that emphasize the role of evidence-based medicine, with compelling clinical and real-world data at the core,and cultivating health outcomes research for long-term data analysis (Figure 1).
PhRMA CodeHealthcare
Financing
Administration

MedicareModernization
Act

MIPPA

(Medicare improvements forPatients and Providers Act)

MedicarePart D Benefit

Pre 20002001 - 2005

2006 - 2010

Payer

Policy Maker

Growing Importanceof Compliant Operations

Merit-based
Incentive
Payment
System (MIPS)

Affordable
Care Act

Alternative
Payment
System Model(APM)

Sunshine Act

2016 - 2025+

2011 - 2015

Digital Advancements
Generating Evidence(RWD/RWE)

Patient

Figure 1. Changes in the Healthcare Landscape: 20 Years

In today’s market, the imperative vision for Medical Affairs is to have a seat at the strategic table early in productdevelopment, and contribute to the target product profile (TPP), which drives clinical research efforts, along withstatistical clinical data and insights from the competitive landscape to develop the medical launch strategy.2
The earlier Medical Affairs can engage in the productdevelopment process the more impact they have on the
success by identifying and communicating critical issues andgaps to support short- and long-term planning. With a deep
understanding of the current standards of care, knowledge of
product attributes, customer insights, and ongoing rigorous
analysis of the competitive landscape throughout the productlife cycle, Medical Affairs has become a valuable strategic
partner. Medical Affairs Professionals have become experts inunderstanding complex science, translating that information
into a meaningful narrative for a diverse audience, anddefining product value within a heavily regulated healthcare
system. With the solid foundation of medical insights, Medical
Affairs can most effectively produce real-world solutions that
ultimately advocate for patients’ health needs.

“

The imperative vision for Medical Affairs is toparticipate in product strategy discussions
early in the product development phase.
Beginning strategic planning as early as five
years prelaunch enhances Medical Affairs’
ability to identify and communicate criticalissues and gaps to support short- and longterm planning.

”

Greg Keenan, MD Former Vice President, Medical
Affairs and US Head Medical Officer, AstraZeneca

With early and ongoing involvement, Medical Affairs is critically positioned as a fulcrum of information,
managing the flow of information into and out of the company, able to leverage this to inform strategy andengagement. Medical Affairs can take the lead in establishing a road map to ensure a successful product launch,
all with unmatched expertise in data generation, data dissemination, external stakeholder engagement, andorganizational support throughout the product life cycle.

4Addressing unmet need is paramount for both patients and HCPs, including clinicians, physician assistants,
nurse practitioners, and pharmacists within the industry. Today more than ever, guidance by Medical Affairs
is crucial to help create the best possible outcomes, particularly when it comes to addressing the knowledge
needs of HCPs throughout the product life cycle. With increased focus, Medical Affairs can better advocate
for patients through early clinical development efforts in Phase II and Phase III. Keeping HCPs informed of theshifting payer landscape is also essential. Attention to these aspects will help provide a stable focus on what isbest for the patient population over time, to support their outcomes and quality of life.
Among all the activities that Medical Affairs leads, in this guidance document we seek to define the key
elements that support launch excellence and discuss how to build, execute, and measure the impact of theseelements over time.

2. MEDICAL AFFAIRS LAUNCH EXCELLENCE
There is no single definition of “launch excellence.” Indeed, all factors involved in attempting to quantify the
success of pharmaceutical launches must first address launch readiness—the steps taken toward an optimallaunch effort and a necessary precursor to launch excellence. Launch excellence requires optimal alignmentof launch strategy and execution to drive efficiency; effectiveness; compliance; consistency and best practices
across countries, therapeutic areas, and management; all while allowing flexibility to accommodate market
changes. It is critical that a launch strategy be in place, is understood, accepted, and applied throughout theorganization to ensure clarity of the steps to be taken.
Launch excellence is achieved by defining the activities, processes, and behaviors required for a highperforming team that will mobilize and focus organizational efforts in preparation for and throughout the launchphase. Individuals who demonstrate commitment and support of the agreed upon organizational objectives
and aspirations will contribute to the development of a high-performing team whose relevant and reliableactions can be leveraged and measured over time.3 Optimal alignment across affiliates, regions, and countries
can improve efficiencies, effectiveness, compliance, consistency, and best practices. By showcasing excellence,launch teams can achieve organizational objectives maximizing patient reach, improving outcomes, providing
credibility, and contributing to the long-term stability of the organization. Through launch excellence efforts,
the Medical Affairs community establishes its role within the pharmaceutical industry and can further create
opportunities to expand its responsibilities and contributions postlaunch.
Global launch excellence is a strategic process that strives to achieve:• A globally, regionally, and locally launch plan aligned with all strategic components—Clinical, Regulatory,
Medical, and Commercial and Compliance Optimization—and prioritization of resources that aligns withoverall organizational vision and aspirations• Robust processes, systems, and tools to support execution• Systematic and structured communication channels (internal and external) to ensure successful
implementation• Common expectations and “shared goals” of “excellence”• A clear understanding of the clinical data differentiator and the underlying value proposition, to support
strategy beyond the clinical offering• A shift from volume-based to value-based healthcare delivery focusing on quality care and health outcomesthat benefits patients, providers, payers, suppliers, and society
Medical Affairs leaders are required to identify and measure key performance indicators (KPIs). In the past,quantitative activity metrics used were based exclusively on product performance in the market, such as
revenue, which is far from optimal given the complexity of identifying the direct impact of Medical Affairs.
Today, outcomes-based metrics to assess the impact of the strategic plan are needed. Medical Affairs needs toestablish these based on the objectives of their medical strategy plan.

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Determining success of the strategic process requires Medical Affairs to:• Establish launch KPIs to evaluate the performance of the medical strategy plan such as, landscape
preparation, publication planning, Medical Science Liaison (MSL) activities, data generation, patient outreachprograms, impact of data disseminated on clinical practice, and bridging the knowledge gap• Analyze all quantitative KPIs against each milestone• Determine adjustments needed based on ongoing assessments

3. LAUNCH EXCELLENCE MEDICAL AFFAIRS TEAM
With deep expertise, members of the Medical Affairs launch
excellence team skillfully collaborate with various functional
units and contribute strengths upon which a successful launch
can capitalize. Having clearly defined responsibilities, crossfunctional team member contributions will lead to efficiencies
and reduce duplicative efforts. Medical Affairs can then leadby ensuring that everyone understands and supports relevant
concepts and by aligning medical communications aroundthose concepts. Launching a new product requires expertisefrom many regional, national, and global colleagues as well
as external contacts, and Medical Affairs can help streamline
objectives.

“

The communication process establishedwithin the medical strategy results inthe synthesis of relevant concepts andeducational messages that are acceptedby all members of the team.

”

Tricia L. Gooljarsingh, PhD, CMPP, SeniorDirector, Ironwood Pharmaceuticals

As a core member of the launch excellence team, Medical Affairs can coordinate the needs of internaland external stakeholders, sharing information with cross-functional teams and providing data to support
strategy (Figure 2). Through this, Medical Affairs helps to solve problems, shape the launch ecosystem, build
relationships, and positively affect work satisfaction goals. In this expanding capacity, Medical Affairs may help
direct external strategic partners to provide services that ensure comprehensive analysis of therapeutic areas,
treatments, and landscapes. The core medical team will expand beyond the physician-expert role to a morecustomer-facing, evidence-generation role (see Figure 3 for key Medical Affairs functional skills). Throughout
product life cycles, strategic partners can provide valuable insights to the core teams based on their functional
skills.

Manufacturing;
Supply Chain

Commercial

Public/Investor
RelationsMarketAccess/Health
Economics andOutcomes Research(HEOR)

MedicalAffairs

PRODUCTLAUNCH
ClinicalPatient
Advocacy

Regulatory

Figure 2. Core Launch Excellence Team6

Medical Affairs
Functional Skills

Core Medical
Affairs Team

Nucleus of the team. Leaders in supporting alignment of corporate vision, deploying change
management as needed and optimizing direction, both internal and external, based on evolving
and influencing factors

External medical face of the organization,
responsible for building and executing an
engagement plan and expanding
thought-leader networks

Medical Science
LiaisonEvidence-Generation
Team

Manages clinical studies (Phase
IIIb and IV), HEOR studies,
investigator-initiated studies, andcollaborative research(hypothesis, objectives, etc)

Generates and analyzes data to
support clinical studies andmarket access/reimbursement

Disseminates and communicates data for the scientificcommunity via abstracts, posters, manuscripts, publications,and congresses; aligns strategic plans with release of clinical
trial results and data at medical meetings; develops consistent medical communication platform (narrative) andlexicon (language) to describe the value propositionof the productExpert resource that prepares answers to
medical questions from HCPs, patients, andother external groups

Supports medical education alignment
to ensure unmet medical need within
therapy is understood

Reviews medical accuracy of promotional materials with Legal, Regulatory, and/orCompliance

Identifies external stakeholders, anddevelops and executes engagement
plans at the national and global level

Medical Information

Medical Regulatory Committee(MRC)/ Promotional Review
Committee (PRC)

HEOR

Medical/Scientific
Communications

Independent
Medical Education (IME)

External Engagement/
Collaboration

Extensive subspecialty knowledge, capable of designing and understanding clinical trials;
assigns, coordinates, and monitors medical/clinical leadership activities and medical strategy,
highlighting short- and long-term unmet needs(Adapted from FirstWord; Crowley-Novak P and Smith)

Scientific Expertise

Figure 3. Medical Affairs Functional Skills4,54. MEDICAL AFFAIRS LAUNCH STRATEGY DEVELOPMENT
A successful launch strategy is dependent on 3 corecomponents and Medical Affairs plays an important leadershiprole in adding value in each area:
1. Strategic plan development early in the product life cycle
2. Assessment of future market and competitive landscapes
3. Establishment of strong product/profile narrative“

Complex scientific communication
challenges coupled with unique regulatory
and cultural differences between regions
can make alignment across a global
Medical Affairs organization seem
impossible. But it doesn’t have to bebecause Medical Affairs can help makeearly decisions on the product that canlead to future successes.

Medical Affairs needs to identify internal and external
partnerships, utilize medical expertise in the clinical data,disease, product, and healthcare market, and serve as
Anna Walz, CEO and Founder, MedEvoke
the primary communicator of critical evidence-based
information to define value.6 The link forged between Medical
Affairs, Clinical Development, and Commercial cannot be
underemphasized as launch procedures are developed andimplemented. Medical Affairs engagement in launch planning can vary among organizations. The optimal time
to begin is as early as proof of concept (Phase II/IIB). Working closely with Clinical Research and Development
and Global Marketing, Medical Affairs has a unique opportunity to take an active role in development of the
product, initiating strategic planning well before a targeted launch plan (Figure 4).

”

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Leverage evidence
to inform decision
making and drive
medical strategy

Use advanced
analytics toproactively seek anduncover insights to
inform strategy

Establish a baseline ofleading and lagging
indicators to better
quantify the impact
of strategy

Develop tactics thatdrive value and alignto opportunities andgaps

Stratify internal andexternal stakeholders anddevelop communicationand engagement tactics
for their needs

Figure 4. Establishing a Strategic Medical Plan
Core countries are best involved with strategic planning discussions very early on as well. By engaging withcore countries, Medical Affairs can build global objectives and strategies that are relevant to country needs
and ensure postlaunch success and effective uptake. Countries will address the perspectives of their respective
country’s market needs, and Medical Affairs will add to its breadth of knowledge accordingly. This includes
information about economic value, payer landscape, and competitive landscape based on disease treatment,
country-specific healthcare systems and medical guidelines, drug coverage requirements, and regulatoryenvironments for each market. Each country has different uptake processes, market beliefs, and customer
insights that can support launch excellence.
As healthcare moves from a volume-based to value-based reimbursement focus, healthcare providers are
incentivized to provide the best care at the lowest cost, improving patient quality of care and satisfaction.
Making this shift requires a clear understanding of patient needs and ongoing assessment of data todemonstrate beneficial impact across stakeholders (Figure 5).
PATIENTSPROVIDERS

Lower Costs
and Better
Outcomes

Higher Patient
Satisfaction
Rates and Better
Patient Care

Medical Affairs
PAYERSSUPPLIERS

SOCIETY

Stronger Cost
Controls andReduced Risks

Alignmentof Prices
With Patient
Outcomes

Reduced
Healthcare
Spending andBetter Overall
Health

NEJM Catalyst (catalyst.nejm.org) © Massachusetts Medical Society

Healthcare
Benefits7
Medical Figure 5. Value-Based
MedicalPartner
LeaderAuthority

Communicator

For launch success, it is essential that Medical Affairs prepares a product for market with great attention to detail.
Building a launch medical strategy road map around the Four Pillars of Core Responsibility will create a highperforming team, Confidential
organizeand define the steps needed to navigate through global challenges, and identify
Property of MedEvoke 2020
1
critical success factors (Figure 6). The medical strategy road map will ensure strategic objectives are identified
and plans are evaluated by KPIs.

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5. BUILDING A MEDICAL STRATEGY ROADMAP
Stakeholder
Engagement

Clarify key medical
communication points,
obtain advice/insights fromcore external groups,
develop external
thought-leader
relationships andcommunity advocacy, andbuild impactful partnerships

Evidence Generation
and Dissemination

In addition to diseaseknowledge, Medical
Affairs brings new
diversified perspectives
that challenge,
stimulate, and drive
thought provoking
discussion

Capture and analyze
medical information to
generate evidence for
optimal patient care andtimely access to that careConnect HCPs, patients,
caregivers, payers, andother external partners todata and insights,
enabling informed
decisions for maximum
clinical impact

Establish a fundamental
infrastructure, including
the right human resource
talent with theappropriate expertise toenable the organization
to deliver critical successfactors and achieve
launch objectives

Organizational
SupportCapability
Development

Figure 6. The Medical Strategy Road Map

A. Organizational support
Medical Affairs contributes to the foundational infrastructure that enables an organization to deliver critical
success factors and medical strategic imperatives. During pre-launch, team members become medical
information experts on the disease state, mechanism of action, competitive landscape, treatment accessissues, reimbursement issues, and clinical data. As the medical information link, Medical Affairs facilitates
the transition from new product development to commercial launch, serving as the operational bridge andcommand center of communication, expertly identifying priorities, and providing strategic direction that
supports the organization in navigating through the treatment landscape. Initiatives that provide organizational
support typically include medical training, participation in cross-functional leadership meetings, and insightdissemination.

B. Capability development
Identifies talent with disease knowledge and diverse perspectives to create and support thought-provoking andstimulating dialogue that drives new ideas and solutions.

C. Evidence generation and dissemination
Medical Affairs collaborates with Clinical Development to
identify gaps that research strategies will address. Medical Affairs
provides invaluable expertise in evidence generation, providing
input into clinical trial design and endpoints for a comprehensive
clinical development program and works with Health Economics
and Outcomes Research (HEOR) counterparts to build economic
evidence (cost models, burden of disease metrics, claims
database analyses, and patient-reported outcomes). Medical
Affairs also anticipates building a real-world evidence (RWE) plan
once the product is approved.

“

Now, we can drive impactful decisionmaking actions by bringing insights andinformation from external sources into thecompany to influence strategies.

”

Meg Heim, RN, MAS, VP, Head of North America
DCV Scientific Communications, NA DCV Medical
Affairs, Sanofi

Clinical differentiators distinguish new products from other competitive products in the portfolio. The main
goal is to continually monitor the ever-changing research findings and novel clinical endpoints that support the
medical communication plan and medical strategy before moving on to specific tactical activities. Continual
engagement with key stakeholders is critical to this effort.

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Medical Affairs leads the development of the medical communication platform and lexicon to ensure cohesive
dissemination of evidence across multiple functions, enabling informed, confident decision making withmaximum clinical impact. Medical Affairs is also responsible for synthesizing and communicating medical andhealth economic information to support launch, payer access, and reimbursement decisions.
In all communications, Medical Affairs ensures that accurate and unbiased information is provided. At the centerof the development process, Medical Affairs brings internal and external stakeholders together and unites themaround a consistent, evidence-based point of view. Disseminating this key information to HCPs will help thembetter understand the clinical impact products can have on their patients.
In addition to developing content to support product use, Medical Affairs can monitor the impact oncontributions in both the scientific exchange (medical peer-reviewed content, posters, abstracts, publications)and in digital domains (social media amplification of scientific discussion), which have become the echochambers of science. Web-based and digital platforms continue to provide HCPs with valuable access to
information in the new and advancing digital world.
Regular assessment of both the scientific exchange and digital domain allows for the gathering of insights into
provider and payer perspectives and related marketing activities. Monitoring efforts in this way allows Medical
Affairs to rapidly identify and address issues as well as measure impact and validate alignment to strategy.
Having this constant “pulse reading” of the therapeutic landscape allows Medical Affairs to have credible
scientific exchanges over time that can evolve with a changing disease dynamic, noteworthy events, or evolving
new classes of therapy that would drastically change the landscape.8

D. Stakeholder engagement and key customer insights
Medical Affairs plays a critical role in clarifying key clinicalmessages to develop thought leader and community
advocacy partnerships. Insights are gained from external
stakeholders and organizations via peer-to-peer interactions.
Based on these interactions, Medical Affairs can assess
implications and determine appropriate solutions.
Initiatives that support thought-leader and decision-makerengagement may include engagement plans, medical forums,
roundtable discussions, external medical expert mapping(where experts are located within the evidence spectrum),post-congress scientific exchange, and peer-to-peer programs.
Medical Affairs relies on gathering intelligence/insights fromthese experts to help identify gaps within the landscape thatcan be addressed by the product, as well as adjust medical
strategies as needed.

“

Medical Affairs needs to embrace digitaltechnology. Our field is data driven. And
when we want to explain our product, wetend to pile on the data. Instead, we should
develop a cohesive narrative. Use the dataon a digital platform to tell a medical story
that can be understood by the healthcare
provider and a value story that can beunderstood by the payer.

”

Lobna Salem, MD, MBA, Chief Medical Officer,
Developed Markets, EMB, Upjohn Pfizer

Medical Affairs then assesses that impact, looking for opportunities to support strategy. In addition, Medical
Affairs supports clinical trials by identifying and engaging with external medical experts who serve as
investigators and provide input on design, site identification, and enrollment.
External thought leader and influencer identification, relationship building, and engagement are efforts thatcreate critical communication channels between Medical Affairs and the external medical and scientificexchange. During early phases of development, Medical Affairs establishes strategic partnerships for activities
necessary to support the product life cycle. Coordinating clinical data release will maximize scientific data
dissemination and understanding as well as familiarity with a product’s medical value proposition.
Today’s HCPs consume a substantial amount of on-demand, high-quality medical content digitally as theneed for rapid access to information and transparency increases. Review of social media platforms will
provide additional insight into what is being said, who is saying it, how it is being communicated, and withhow much impact. With increased use of social media platforms to disseminate scientific information and incertain instances share opinions, there is a need to identify key digital opinion leaders and understand themost resonant topics of discussion.9 Digital opinion leaders (DOLs) are important external stakeholders who
are driving and influencing the dissemination of science through unique and varied channels. DOLs may be

10HCPs who have the capability to influence a much larger network of stakeholders including other HCPs, payers,advocacy groups, and patients. It is critical to identify, understand, and engage with them, as they can yield apowerful breadth and depth of influence including clinical decision making.
It is also essential to focus on engaging payers to define the value of therapies. Medical groups are asked todeliver robust medical information to managed care organizations, group purchasing organizations, and the
newly forming pathway groups that define treatment protocols. Engagement can occur via the core medicalgroup staff, through specialized Medical Science Liaisons, and all other subspecialties within field medicalgroups.
The Medical Affairs Key Activities for Launch Excellence table provides a sample of key activities to support
launch excellence based on projected timeframes of launch preparedness (Figure 7). To initiate a launchplan, it is critical to assess timing and resources to accommodate the best plan for optimal data generation,dissemination, and engagement.
12

0

-12
-24
-36
-48

Prelaunch(T= -48 to -24 months)

Medical Leadership:
Strategic Planning– Early Medical Insights for Clinical Development– Medical Team Formation and Expansion– Development of Strategic Imperatives– Conduct Situational and Gap Analysis– Identification of Unmet Needs– Building Cross-Functional Partnerships

Perilaunch(T= -24 to -12 months)

Launch(T= -12 to 0 months)

Postlaunch(T= 0 to 12 months)

Cross-Functional (Medical/Market Access) Strategic Development & Execution

Life Cycle Management/
New Product Development

Launch Readiness Planning and Launch Execution Excellence

Medical Research:
Data/Evidence Generation

Medical Information &Communication:
Data/Evidence Dissemination– Evidence Generation Planning– Support Programs and Deliverables to Drive Valueand Align to Gaps and Opportunities– Leading and Lagging Indicators– Maximize Data Sources– Identify Patient Care Needs– Clinical Program Support (Recruitment, Site Support,
Educate Scientific Community on Phase III Study Protocol)– Building Cross-Functional Partnerships– Key Communication Objective Development– Communicate Early Trial Data
– Create Medical Communication Platform– Develop Education & Publication & Congress Plans– Data Dissemination Strategy– Lexicon Development– Identify Key Tools

Provide Internal Disease and Product Information Training
Medical Knowledge/
Management:
Education, Communication

Partnership/Interactions:
Medical Community/
Stakeholder Engagement

Organizational
Support– Outcomes Research Studies– Investigator-Initiated Research Planning and Execution– Medical Advisory Board– Post Approval (eg, Phase IV)– Study Strategy & Planning– Post Approval (eg, Phase IV) Study Execution– Patient Registry Trials

Medical Communication Planning

Medical Communications Execution (Publications, Congresses/Symposia)– Medical Education and Grants Management– Medical Advisory Boards

Medical Information Planning– Medical Advisory Board Planning– Medical Education Planning– Medical Information (Unsolicited Requests, SRLs, FAQs, Call Center)– Execution & Updates– Report on Product Insights– Medical Advisory Board– Medical Education and Training

Field Medical Training

Medical Community Planning

Establish a Team of Medical Information Experts(Disease State, Mechanism of Action, Competitive
Landscape, Access, Reimbursement, Clinical Data)– Medical Community (Thought Leader/HCP, Payer & Policy Makers, Patient Groups, Advocacy Groups)– Engagement and Development– Gather Feedback on Opinions, Interests, and Experience– Facilitate Transition From New Product Development
to Commercial Launch– Provide Medical Training, Participate in Cross-Functional– Leadership Meetings and Insight Dissemination Efforts

Insight Dissemination from RWE, HCP Interactions,and Medical Information Requests*Launch is an evolving and fluid process.

Figure 7. Medical Affairs Key Activities for Launch Excellence*11

6. GLOBAL MEDICAL AFFAIRS STRATEGIC ALIGNMENT
Organizational strategic alignment with Commercial is critical to all efforts. It is accomplished when Medical
Affairs forms strategic partnerships across departments to develop the globally aligned strategy and to
determine what the current situation is, what the desired situation is, and how we get from one to the otherusing medical strategic imperatives to tap potential select markets worldwide. Medical strategic imperatives,
driven by critical success factors, function to align Global Medical Affairs initiatives.
When developing a strategy, Medical Affairs examines disease type; identifies patients, diagnostic guidelines,
product characteristics and differentiators (eg, administration, efficacy, safety, pharmacokinetics, mechanismof action, and cost), competitors; and determines the product portfolio. Medical Affairs advises on alignmentof strategy from the foundation of the clinical trial plan and develops consistent language to describe clinical
trial results. A fully developed strategy will communicate a single clinical message that will form the basis of thevalue proposition supported by a uniform lexicon.
A solid unified organization-wide road map requires a single strategic direction, which is built on thecooperative efforts lead by Commercial with significant input from Medical Affairs incorporating bothcritical success factors and medical strategic imperatives. Once strategic direction is finalized, a continuous
collaborative effort between Commercial and Medical Affairs is essential to evaluate a full landscape overview todefine unmet needs, attain key customer insights, and develop a Strengths, Weaknesses, Opportunities, Threats(SWOT) analysis to transparently identify opportunities for success. This information will drive a clear, tacticaldelivery plan for each unit within Medical Affairs.
For effective global alignment, a thorough analysis of the resources available from country to country is needed,
as it will impact product launch and all postlaunch activities. Maintaining institutional knowledge and using
analytic skills to translate historic data for its effective use must take into account timing factors and all otherconsiderations specific to each country within the global plan to ensure launch effectiveness.
Each functional area should be challenged to identify key medical objectives that work to successfully
implement the strategic imperatives. This makes the imperatives more accessible to day-to-day operations andallows a line to be drawn for individual tactics. A narrowed approach makes the critical success factors relatableto tactical activities. Tactics need to be developed from objectives and strategies that can be readily identified byfunctional area.
Developing a medical narrative early in a product’s life cycle is essential for determining critical success factors
and creating a market-shaping platform that addresses the unmet medical need. (Figure 8). The medical
narrative serves as the foundation particularly for complex therapeutic areas requiring long-term education andmessaging to establish a successful product niche.

Unmet
Medical Need

MedicalNarrative

Brand Critical
Success Factors

Functional Area
Medical Objectives

Figure 8. Functional Area Objectives

Functional Area
Tactics

12

7. ROLLOUT STRATEGIC PLAN CUSTOMIZED BY REGION
Organizational stakeholders need to be informed of rollout tactics, time lines, and deliverables. As companies
vary by size, number of employees, corporate cultures, product lines, and financial resources, there is no onesize-fits-all approach for executing tactics and developing tools for a global launch. However, by assessing
learnings and best practices throughout the launch process, Medical Affairs can be well prepared to address anyneeds that arise.

8. MEASURING MEDICAL AFFAIRS STRATEGY IMPACT AND VALUE
Medical Affairs has an important part in driving market entry as many crucial activities should occur well inadvance of the launch. The impact of the medical strategy should be re-examined regularly to reflect emerging
new data, changing treatment paradigms, and shifting market forces. It is imperative to have a continuous
feedback loop following the launch, too, as new product line extensions or indications surface. Ongoing
monitoring will ensure product messages and the clinical promise remain consistent, measures can be put inplace to overcome challenges, maintain relevance in the marketplace, and provide a basis for conscientious
well-founded decisions.
Determining KPIs will measure the success by which functional area objectives and tactics can be evaluated.
KPIs associated with data generation may include how tactics address payer and regulatory needs, demonstratevalue, meet local and global market access requirements, and articulate the value proposition with supporting
evidence. KPIs associated with data dissemination may include the ability to create differentiating product value
and the development of medical information to address FAQs. The ability to assess relationships with external
medical experts through engagement and understanding is key to guiding development and refining content.10
Today, Medical Affairs professionals have access to an array of powerful, global data sources (publications,conference presentations, clinical guidelines, registry data, the social/digital exchange). By filtering,interrogating, extracting sentiment, and monitoring such data, powerful insights can be yielded into competitive
activity, uptake of medical strategy globally and/or regionally, and identify gaps in resourcing and scientificcommunications.
When overlaid onto medical imperatives, the insights gleaned from these data analyses can validate medical
launch strategy plans and be used as KPIs against the plan, ultimately providing another avenue by which
Medical Affairs can demonstrate impact and value for the launch excellence process.
Analytics and insight synthesis aid in this, aligned around a common set of medical imperatives that serve as thefoundation for search strategy and analytics for affiliates.

Analytics and insight synthesis will demonstrate impact and value ensuring:
1. Analysis of communication efforts in the global scientific and digital exchange, quantitatively and qualitatively(Figure 9)a. Internal efforts/programs/insights
b. Congresses/journals
c. Digital domains
2. Tracking the impact efforts have on the therapeutic space, to determine how future efforts should beincorporated into medical plans
3. Review of ongoing data assessments and insights against medical plans

13

DigitalInternal Efforts

Congress/Journal• Abstracts/Symposia• MSL Interactions• Educational Campaigns• Medical Information• Public Affairs• HEOR• Who/What/Where• KOL-Institution-Geography-Industry Affiliation• Who/What/Where• Digital KOL/HCP-Patient/ Advocacy-Payer-Association/Societies

Scientific Exchange

Digital Domain

Figure 9. Internal Communication Efforts Influence Scientific Exchange

9. A NEW AND GROWING VISIONARY ROLE FOR MEDICAL AFFAIRS IN LAUNCH EXCELLENCE
A product launch is a critical strategic undertaking for Medical Affairs. With crowded therapeutic markets anda restricted promotional environment, Medical Affairs is positioned to have an increasingly visionary role inlaunch preparedness and strategic planning to affirm the clinical value of new therapies. The need for moresophisticated approaches that emphasize the role of evidence-based medicine, with compelling clinical andreal-world data at the core, and health outcomes research for long-term data analysis has dramatically changed
the role of Medical Affairs. Now, Medical Affairs leaders need to implement the new paradigm, excel as strategic
partners with Commercial, and collaborate with Regulatory, Clinical, and Market Access on scientific strategy.
Having a seat at the table early in the strategic planning process provides Medical Affairs an opportunity to takethe lead on product development as experts in current standards of care, product attributes, and the global
competitive landscape, over the short- and long-term life cycle of the product.
In this evolving capacity, Medical Affairs must address theincreasing complexity of the changing healthcare landscape,key decision-maker needs, and the evolving demandsof patients, payers, and HCPs. As internal and external
stakeholders set increasingly higher bars for the levels ofscientific evidence needed to support a product’s value
proposition prior to launch, it is critical that Medical Affairs
understands the disease area, has an in-depth understandingof healthcare systems, and internal and external stakeholder
requirements to take the lead in establishing a strategic road
map. This is where Medical Affairs’ expertise in evidence
generation, evidence dissemination, stakeholder engagement,
and organizational support is most valuable.

“

The imperative vision for Medical Affairs is tohave a seat at the strategic table early inthe product development phase, and to bewell positioned to take the lead on scientificstrategy development.

”

Paul Tebbey, PhD, MBA, Therapeutic Area Head,
US Oncology Medical Affairs, AbbVie

Launch excellence requires optimal alignment of strategy and execution to drive efficiency, compliance, andbest practices across countries and therapeutic areas, while accommodating market changes. It is critical that awell-prepared launch strategy be in place, and is accepted and applied throughout the organization to ensure
clarity of steps required by all if launch excellence is to be achieved. Monitoring the impact of both the scientificexchange and digital domains, which have become the echo chambers of science, provides a pulse reading of
the therapeutic landscape. This allows Medical Affairs to have credible scientific exchanges that evolve along with14
the changing disease dynamic, noteworthy events, and evolving new classes of therapy. Medical Affairs also
plays a critical role in identifying key digital opinion leaders and decision makers, clarifying clinical messages,
assessing implications, and determining appropriate solutions as needed.
Functional area experts must identify key medical objectives that work to successfully implement strategic
imperatives. Utilizing easy-to-use, customizable templates during the strategic planning process will provide
structure, support consistency in communication, and help create common expectations for each functional
area during planning. Sample templates for launch excellence planning can be found here.
The impact of the medical strategy should be re-examined regularly to reflect emerging new data, changing
treatment paradigms, and shifting market forces. It is imperative to have a continuous feedback loop following
the launch too, as market dynamics continuously change. Ongoing monitoring will ensure product messages
and the clinical promise remain consistent. Measures can be put in place to identify and overcome challenges,
maintain relevance in the marketplace, and provide a basis for well-founded decisions. Complex therapeutics
driven by ever-evolving science require an ongoing collaborative effort to ensure alignment of a product’s
medical platform with its commercial strategy.
While COVID-19 has had a major disruptive impact on all aspects of life on a global level, Medical Affairs
professionals play a pivotal role in ensuring that timely and accurate, evidence-based scientific information
continues to be available and communicated to HCPs to meet the needs of and protect the health and wellbeing of their patients. As the course of the pandemic evolves and challenges arise, there are also newopportunities. Adapting and finding innovative solutions to gain insights, share information, and assess thehealthcare landscape has never been more critical.
Seemingly, the world has gone digital overnight. Digital platforms have become the new communication
method for interacting with customers for rapid and often real-time information sharing. Data are key anddigitalization is now the norm. Virtual engagement with HCPs is a necessity rather than option. Physician andpatient communication have gone digital with online visits. How clinical trials are being conducted is being
reassessed. Advocacy groups are creating and providing virtual support initiatives. New opportunities exist fordata dissemination as seen in the rapid release of prepublication data, analysis, and results. Face-to-face medical
education initiatives, advisory boards, and professional society meetings are now being conducted in a virtual
setting.
Medical Affairs must continue adapt and gain competencies in the digital arena as we have been thrust into thisnew norm. As Medical Affairs professionals, we must continue to prove our adaptability, proactive, strategic, andtechnologically savvy capabilities, to ensure that patient needs are addressed and they continue to receive theoptimal healthcare available.
As treatment paradigms and market influencers change, and the patient voice becomes more pronounced andinfluential, so must the role of Medical Affairs professionals. Medical Affairs Professional Society (MAPS) offers
colleagues a forward-thinking environment that provides innovative and interactive learning and development
programs and virtual communities to share ideas and experiences. Network with other professionals and partner
to develop best practice papers, as Medical Affairs grows in vision. Join and engage in the growing MAPS
community to gain expert insights that can be immediately applied to your organization.

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Glossary of Terms
DOLs

Digital Opinion Leaders

FAQs

Frequently Asked Questions

HCP

Healthcare Provider

HEOR

Health Economics Outcomes Research

KPI

Key Performance Indicator

MSL

Medical Science Liaison

R&D

Research & Development

RWE

Real-World Evidence

SWOT

Strengths, Weaknesses, Opportunities, Threats

TPP

Target Product Profile

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