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Drug Discovery Today  Volume 00, Number 00  November 2019 PERSPECTIVE

feature
Q2 Building the case for developing a
medical affairs patient-centric
framework collaboratively
Q3 Rebecca Ashkenazy

Within the biopharmaceutical environment there are increased expectations for medical affairs to serve as
a patient-understanding facilitator, engagement champion and empowerment enabler. The collaborative
development of a medical affairs patient-centricity framework to characterize avenues of medical affairs

Features  PERSPECTIVE
patient-centric activity could enhance transparency of objectives, input and outputs of medical affairs
interactions with the patient. This article presents an initial opinion regarding how the field of medical
affairs interacts with patients to advance patient centricity. The proposal: medical affairs engages and
collaborates with patients through strategic leadership, medical communication, evidence generation,
patient engagement and experience of patient care. Once validated, such a framework’s implementation
could help clarify medical affairs competencies and behaviors necessary to optimize associated effort.

Patient centricity and medical affairs
The concept of patient centricity from definition
and application to value assessment and evolution
has been a topic of debate within the biophar-
maceutical industry [1–4]. Similarly, the medical
affairs function can be characterized differently
based on organization type, composition, thera-
peutic area and roles. It is thus not surprising that
there are mixed perceptions of the relationship
between medical affairs and patient centricity.
Some believe the centrality of patients has long
been an unwavering principle of the function
through its responsibility to represent the ‘voice of
the patient’ within an enterprise. Others argue that
patient centricity represents a significant culture
shift within medical affairs from a more
E-mail address: Rebecca_ashkenazy@pfizer.com.
paternalistic view of patient insight inclusion to a
more collaborative engagement of patient and
associated family and care partners to fuel medical
product development. There are new expectations
of medical affairs to facilitate
patient understanding, champion patient
engagement and enable patient empowerment.
The function’s ability to address the question: have
we exchanged ideas with patients about that?
represents a distinguishing value proposition and
reflects an iterative process of asking patients for
input, listening to their response, translating the
input into insights and actioning to address their
needs.
No matter the point of view, environment trends
are driving toward more-direct patient interaction.
Patients are taking a more informed and active role
in their own healthcare as demonstrated through
the concept of e-patients, who are equipped,
enabled, empowered and engaged in their health
and healthcare decisions [5]. Regulatory agencies
such as the FDA are establishing expectations for
integrating patient centricity into development
through advisories and other collaborations [6].
Payers are incorporating patient insights more
actively in their policies [7]. In addition, R&D or-
ganizations are engaging patients earlier and more
consistently throughout the development cycle to
support product value and limit asset attrition [8,9].
Medical affairs can participate in or lead these
efforts, becoming increasingly important.
The rationale for developing a medical
affairs patient-centricity framework
There is value in clarifying medical affairs patient-
centric effort given expected increasing

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 DRUDIS 2588 1–5
PERSPECTIVE
FIGURE 1
Medical affairs perspective: medical affairs patient-centricity framework. Five focus areas across three
dimensions.
interactions between medical affairs and patients
and potential ambiguity around them. Presented
below is one input to such a framework: a
proposed medical affairs perspective in which
Features  PERSPECTIVE
medical affairs colleagues operate and collabo-
rate with patients to advance patient-centricity
focus areas of strategic leadership, medical
communication, evidence generation, patient
engagement and experience of patient care
(Fig. 1). Focus areas are overlapping and
interconnected, reflect direct to indirect
interactions, occur across the research,
development and commercialization continuum
and the term ‘patient’ refers to patients, patient
care groups, patient advocates, family or care-
givers. Once validated, a framework can help:
 increase transparency of intent, function and
scope of associated activity;
 enhance information exchange and quality of
interactions;
 optimize associated training;
 support management, continuous improve-
ment or value assessment;
 highlight ethical, compliance, process or
regulatory requirements.
Medical affairs patient-centricity
perspective focus areas
Proposed medical affairs patient-centricity
perspective focus areas, their rationale for in-
clusion, value drivers and illustrative outputs are
described below and in Table 1.
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Drug Discovery Today  Volume 00, Number 00  November 2019
Drug Discovery Today
Medical strategy
A portfolio-provider-patient triumvirate
grounds much of medical affairs strategy and
showcases a patient-centricity focus. Product or
portfolio assessments revolve around patient
use, access to and need (met and unmet) for
services or therapeutics. Provider assessments
relate to patient–provider interactions and
insights. Patient assessments reflect the patient
experience or journey. Medical affairs can also
develop enterprise patient-centricity strategies
and deploy supporting tools to evaluate
associated activity [10]. Interacting with patients
to understand their journey, perception of value
and appreciation of risk represent a first stage of
medical strategy development. A more
aspirational goal is collaborative strategy
development with patients based on mutually
developed goals, being aligned accordingly.
Medical communication
Depending on role and regulatory construct,
medical affairs can be responsible for,
accountable for or consulted on a myriad of
healthcare communications to support patient
and stakeholder decision making needs
including education, scientific publication or
promotion. Working with cross-functional teams,
medical affairs places patients at the center of
medical narrative development or content review
to consider patient impacts as well as accuracy,
balance and tone. In countries like the USA and
New Zealand, direct-to-consumer (DTC) promo-
tion can be a focus [11]. Clinical trial lay-
summaries are another illustrative patient-centric Q7
communication initiative with relatively wide use
among biopharma [12]. Technology advances are
increasing the number and type of communica-
tion channels to patients as well as the ability to
provide tailored content to support appropriate
product use or adherence [13,14]. A patient-
centric focus emphasizes direct outreach to
patients to solicit their specific communication
needs and channels and even collaborate content
development.
Evidence generation
Patient-reported outcomes and patient-
informed clinical trial design and recruitment are
prime examples of patient-centric evidence
generation [15]. Technology trends will only
increase trial and real-world information
generated as well as patient awareness of,
access to and control of this informaion [16,17]. Q8
In tandem, patient, public and private data
collaborations are increasing in number [18].
The explosion and integration of precision
medicine, electronic medical records, wearables
and social media data along with new analytic
approaches create a need to identify and access
clinically meaningful evidence streams and
collaborations. The Clinical Trials Transformation
Initiative launch of a tool to help sponsors and
patient groups identify high-value opportunities
to collaborate also reflects this priority [19].
Medical affairs in conjunction with its R&D and
clinical partners will have to help manage the
balance between patient data transparency and
protection needs and educate patients about
the regulatory paradigms that impact
associated interactions. In addition, ensuring
that patients find value from their involvement
represents a medical affairs patient-centricity
goal.
Patient engagement
Partnering with patients to integrate their insights Q6
into the medical product development lifecycle
and identify healthcare solutions is an emerging
priority [20]. Medical affairs colleagues can engage
patients and advocates through mechanisms such
as advisory boards, professional panels and online
communities [21]. Patient initiatives can support
pipeline development, product enhancement,
policy campaigns or other objectives related to
product education, supply management, benefit:
risk evaluation or access. Open innovation
illustrates the dynamism of patient engagement
with respect to participants, goals and exchange
types [22]. As an epicenter among stakeholders,
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Drug Discovery Today  Volume 00, Number 00  November 2019 PERSPECTIVE

TABLE 1
Medical affairs patient-centricity focus areas including description, inclusion rationale, value driver and illustrative outputs
Focus area Description Inclusion rationale Value driver Illustrative outputs

Medical strategy
Medical communication
Evidence generation
Patient engagement
Design and align medical
affairs efforts with
organizational mission to
improve patient health
Exchange healthcare
information with patients
and/or develop, interpret
and review medical content
Partner with patients to
advance or interpret clinical
trial or other evidence-
generation activities
Partner with patient, patient
care groups, family or
caregivers to understand
Mechanism to develop,
prioritize, execute patient-
centric efforts
Mechanism to exchange
information to support
service or product
development or related
decision making
Mechanism to enable
evidenced-based service or
product development and
regulatory approval
Mechanism to collaborate
on goals, solicit patient
insight
Enhanced alignment and
allocation of activities and
resources to enable patient
and organization goals
Enhanced stakeholder
understanding, decision
making related to service or
product development and
patient utilization
Enhanced data, trial design,
trial experience and/or
collaboration to support
service or product
development, approval and
patient utilization
Enhanced research,
development
commercialization
Patient experience/needs
assessment, journey maps
Product and portfolio
assessment, lifecycle
planning, product
enhancement initiatives,
stakeholder management
plans health hazard,
benefits:risk assessment
Patient-centric strategy and
plans
Promotional,
nonpromotional, market
research review/content
Scientific publications,
medical inquiry response
Provider/patient education,
information exchange and
collaboration
Patient reported outcomes,
preferences insight, benefit:
risk/quality of life
assessment, patient-focused
trial design, recruitment
plans
Patient data exchange,
transparency collaborations
Patient, patient advocate
conferences, advisories
Patient spokesperson,

Patient care experience
unmet medical need, solicit
insights, address other
objectives
Interact with patients
through healthcare training
or provider experience
Mechanism to support
informed role execution and
patient understanding
through training and/or
experience
productivity and policies to
support improved patient
health
Enhanced context and
subject matter expertise to
expand empathy for and
understanding of patient
journey, value assessment,
rights and needs
Features  PERSPECTIVE
ambassador, advisor or
mentor programs
Multidisciplinary, patient
collaborations/initiatives
Training as physician,
pharmacist, nurse or other
healthcare professional

medical affairs can advance patient engagement to
fulfill the ideals of patient centricity through an
appreciation of its benefits and the special honor
and privilege of the exchange. Moreover, the
function can work to ensure that the appropriate
leadership, governance, operating principles and
codes of conduct are in place among patient and
industry partners to manage potential conflicts of
interest [23].
Patient care experience
Many medical affairs professionals have had
care leaves an undeniable imprint on an indi-
vidual: face-to-face patient–provider interac-
tions are highly personal. The direct observation
of illness and treatment helps give medical
affairs colleagues a unique perspective of the
patient receiving a medical product and the way
that patients perceive or interact with
the healthcare sector. This view could elevate
patient-centric activity from work prioritization
and benefit:risk assessment to understanding
and empathy for the patient journey. Impor-
tantly, interactions between patients and med-
product information or guidance. It is crucial to
navigate this nuance professionally and to be
transparent about in external interactions.
Evolving medical affairs competencies
and behaviors
This presented perspective suggests medical
affairs competencies support patient centricity
and the medical affairs trial role as the patient-
understanding facilitator, engagement champi-
on and empowerment enabler (Fig. 2).
 Integration of patient insight. To achieve

experience or training as healthcare providers
and some continue to see patients. This back-
ground arguably provides medical affairs a
foundational scientific or medical expertise,
context and perspective to engage patients to
understand their needs. Moreover, direct patient
ical affairs colleagues functioning in industry are
highly managed and regulated. There is
distinction in serving as a provider and giving
individual patient care recommendations in a
healthcare setting versus serving as an industry
medical representative to provide general
value from a patient-centric medical strategy,
colleagues must listen to, understand and
integrate patient insight into their
assessments and plans executing them in a
coordinated, consistent and compliant man-
ner. There is research suggesting potential

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 DRUDIS 2588 1–5
PERSPECTIVE
FIGURE 2
Medical affairs patient-centric evolving roles and competencies.
gaps in patient–provider interactions in
communication, listening skills or under-
standing of nonmedical needs interactions
[24–26]. As an intersection among multiple
stakeholders across the healthcare ecosys-
tem, medical affairs can take advantage of
Features  PERSPECTIVE
communication learnings, best practices and
innovations to optimize efforts.
 Multichannel, multistakeholder information
exchange. A facility with evolving data and
digital enhancements supporting multichan-
nel, multistakeholder communications is a
medical affairs competency. A patient-centric
focus further emphasizes medical affairs
attention to patient health literacy principles
and regulations concerning healthcare
information exchange such as use of trusted
intermediary as appropriate. The use of the
medical narrative and storytelling to support
communication efforts are aligned skills.
Structured and unstructured learning oppor-
tunities within and outside the healthcare
environment can support development of
this competency.
 Patient-focused evidence development.
Collaboration with patients for evidence
generation requires an understanding of
evolving regulatory parameters, data and
analytics innovation and patient data rights.
Colleagues will need to engage in the topic of
compensation for patient involvement in
medical product development and the
associated management and disclosure of
perceived or actual conflicts as it has with
other experts who engage with industry.
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Drug Discovery Today  Volume 00, Number 00  November 2019
Drug Discovery Today
 Risk-managed patient collaboration. Medical
affairs must have the competency to design
and implement patient engagement efforts
that support mutually aligned objectives in a
compliant and transparent manner. Collea-
gues must also have skills to assess engage-
ment patient impacts, protect patient rights,
manage potential risks (including potential
conflicts of interest) and serve as patient
advocates. Partnerships with compliance,
regulatory, legal and patient advocate subject
matter experts can support development of
this skill set.
 Patient healthcare journey-informed interac-
tions. Scientific training grounds medical
affairs competency to advance informed
therapeutic and evidence-based discourse
regarding healthcare delivery. Patient care
experience can also result in an enhanced
appreciation and empathy for the patient
experience. In this context, ensuring their
interactions empower patients in their
healthcare journey becomes a pivotal detail
for medical affairs to address.
Certain behaviors underpin patient-centric
efforts. Respect for patient autonomy and
privacy is foundational. Also crucial is the
recognition of the integral contribution of
patients to service or product development and
a commitment to collaborate with them as
partners. The continual demonstration of the
highest degree of medical integrity regarding
interactions with patients (by medical affairs) is
paramount. In parallel, there should be organi-
zational recognition that these competencies
and behaviors can be developed and optimized
through training, work and non-work experi-
ence, colleague modeling and best-practice
sharing.
Validation, implementation and future
efforts
The presented opinion is a first step in the
development of a framework. Although this
perspective serves as a point for topic debate, it
was not developed in conjunction with patients
and originates from a medical affairs perspec-
tive. To take this concept forward, a multidisci-
plinary and partnered effort with patients,
patient advocate groups and public and private
biopharmaceutical stakeholders to develop, test
and validate a framework is necessary. For
example, partnering with patients to assess their
knowledge, expectations and needs of medical
affairs is a key next step. In addition, mapping
the full spectrum of medical affairs, patient and
system infrastructure, process and competen-
cies across biopharmaceutical organization
types and validating them with patients might
prove useful [27,28]. Use of guidance on patient
engagement by private and public institutions
would probably support these activities.
Once validated, a framework can be imple-
mented in a variety of ways. For patients, it can
help educate on the medical affairs role, provide
insight into where within their healthcare jour-
ney there is either indirect or direct medical
affairs engagement and showcase collaboration
opportunities. For medical affairs, it can improve
the efficiency with which colleagues engage on
the topic of patient centricity, support their
modeling of behaviors and advance training.
Used with patients and other stakeholders, the
framework can serve as a backbone for a stra-
tegic evaluation of medical affairs patient-
centric effort. It also reinforces the due care
necessary to minimize associated risks or
perceived risks.
Concluding remarks
In 1865, Dr Harvey Cushing professed, ‘A
physician is obligated to consider more than
a diseased organ, more than even the whole
man – he must view the man in his world’ [29].
More than 150 years later, an inspired reflection
on the role of medical affairs and patient cen-
tricity emerges: medical affairs professionals
must consider and partner with patients in their
world to support their healthcare experience.
The medical affairs identity is interwoven with
patient centricity and environmental trends are
expanding this role across the biopharmaceu-
tical continuum through indirect and direct
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Drug Discovery Today  Volume 00, Number 00  November 2019
patient facing efforts. The function can be
expected to be a nexus for patient centricity
given their training, experience and organiza-
tional role. A continued focus on the infra-
structure, processes, skills and behaviors for
effective medical affairs engagement in this area
is necessary to support optimal role execution
and mission to serve patients.
Conflicts of interest
The author is employed by Pfizer, a multinational
pharmaceutical corporation. The views and
opinions expressed in this article are those of
the author alone and do not necessarily reflect
the official policy or positions of her associated
institution. The author received no financial
support for the research, authorship and/or
Q9 publication of this article.
Acknowledgments
Dr Roz Schneider and Dr Edward Power are
acknowledged for review of first and final drafts,
respectively.
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Rebecca Ashkenazy
Pfizer, US Men’s & Women’s Medical Affairs Lead,
United StatesQ4Q5 Q4
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