When developing a business strategy centered on the patient, organizations must adapt and implement programs that foster information sharing and collaboration while providing faster and greater access to life-changing products.

1. The Patient Journey
Whendevelopingabusinessstrategycentredonthepatient,organisationsmustadapt
andimplementprogrammesthatfosterinformationsharingandcollaborationwhile
providingfasterandgreateraccesstolife-changingproducts
One of the most notable changes in the pharmaceutical
industry over the past 10 years is the market shift towards
implementing patient-centric practices, programmes, and
initiatives as patients are empowered to become more
knowledgeable and involved in their treatment. As a result,
many life sciences companies are adapting to revolve
around the patient at every step of the product lifecycle.
This shift from product centricity to patient centricity is
moving at varying rates, but it is generally agreed that
better patient centricity results in better business and
patient outcomes (1).
‘Patient centricity’ can be thought of as the process of
designing a product, service, or solution around the
patient. In reference to medical products, patient centricity
is often the focus during clinical development, with the
safety and outcome of every patient in a clinical trial being
paramount. During post-approval, the focus is distributed
across payers, healthcare providers, regulators, and other
company stakeholders. Building patient centricity into
every phase of the drug development process requires
a comprehensive approach that draws upon numerous
stakeholders within the healthcare ecosystem.
Today, life sciences companies are looking holistically at
the entire patient journey, remaining close to patients and
providing them with new support mechanisms, such as
online forums, while gathering valuable data and evidence
from sources such as portable devices and apps. Patient
support, market access, real-world evidence (RWE) and
Phase IV programmes not only allow patients to gain
access to safe and effective treatments, but also receive
a more personalised and informed therapy, positively
influencing their treatment outcome. The ability to
demonstrate patient-focused clinical and post-marketing
outcomes helps shape the commercial success of a medical
product. A lot can and should be done to gather, interpret,
and disseminate information about health economics and
outcomes to determine product value.
From Clinical Trials to Post-Marketing
‘Patient centricity’ and ‘patient-centric trials’ have become
industry buzzwords, but there is still much to be done
when it comes to real-world implementation. Figure 1
(page 27) illustrates the clinical-trial continuum from a
participant perspective (2). Organisations must address
the patient’s needs at every phase of the process to ensure
trials are designed in a way that is not just scientifically
rigorous, but also incorporates the patient’s perspective.
Clinical Trials
Trial-planning activities to improve patient centricity
may include live protocol simulations, patient advisory
boards, other means of soliciting patient and caregiver
input on what a trial should include, and protocol review
committees that consist of a wide range of interested
stakeholders from outside the organisation.
Once the trial is under way, scheduling regular
patient experience evaluations on top of standard
clinical assessments is advisable. The use of e-diaries,
wearable devices, and ‘bring your own devices’ can
make participation in the trial easier and more interactive.
Communication with participants is key, and simple
measures such as participant newsletters and brochures
written in lay language can be impactful.
As the trial comes to a close, a simple "thank you" for trial
participation can go a long way and may lead patients
to share their positive experience with others and
consider participation in future studies. Sharing trial
results with participants in simple terms is a must-do
for improving engagement, but is often overlooked.
Soliciting feedback and measuring patient satisfaction
following the study can also be helpful (2).
Post-Marketing
When it comes to the post-marketing phase, commercial
imperatives come to the fore. An ever-changing array
of economic drivers, decision makers, reimbursement
models, and regulations may impact the commercial
value of a treatment in today’s marketplace. A wide
range of activities need to be undertaken to build patient
centricity into the post-marketing phase. At this stage
of the product lifecycle, engagement and collaboration
with diverse members of the healthcare ecosystem
is critical. Some key areas of focus include patient
safety and risk management, RWE, market access,
patient support programmes, healthcare professional
(HCP) support, payer relations, and clinical outcomes
assessments.
Susan Najjar
at Sciformix,
a Covance
company
ICT Patient Centricity in the Product Lifecycle
26 ICT l August 2019

2. www.samedanltd.com l ICT 27
Figure 1: Overview of typical clinical trial phases and examples of patient centricity gaps (2)
Patient Safety and Risk Management
Due to the dynamic regulatory environment, product
safety and the ongoing monitoring of the benefit-risk
relationship continues to dominate the priorities of
life sciences organisations. The patient perspective is
an essential component of drug safety and
pharmacovigilance (PV), but many organisations have not
turned the curve to move from a product-centric approach
to a proactive, patient-centric approach. PV organisations
that incorporate the patient’s voice in PV systems and
processes are better positioned over the long term to
protect patient safety and enhance product benefit-risk
profiles.
The shift from pure safety analysis to benefit-risk
evaluation and, thereby, the overall approach to
implement an effective patient-centric PV model is
entrenched in four main steps: to educate, encourage,
engage, and enable patients.
• Educate: one of the key approaches in patient-centric
PV is raising patient awareness about the importance
of reporting adverse drug reactions (ADR) and
continuously highlighting the critical role they can play
in PV from adverse event (AE) reporting through to risk
communication
• Encourage: measures such as the direct appreciation and
recognition of clinical trial subjects and patients who
report AEs, both online and through other face-to-face
channels, are useful. This includes providing incentives
(non-monetary) to patients and consumers to encourage
ADR reporting
• Engage: the directive 2010/84/EU (Article 102) proposes
guidance that encourages direct patient reporting via
appropriate measures, including web-based formats and
alternative formats (Article 102b), to encourage patients
and HCPs to report suspected ADRs to the national
competent authorities
• Enable: active involvement of patients and the public
in AE reporting is possible by the use of effective and
patient-friendly reporting systems, channels, and
processes (driven by or independent from technology).
This can be achieved by designing and deploying simple
and easy to use ADR reporting tools and processes
Overall, adopting a patient-centric approach and
partnering with patients and healthcare professionals
for the reporting, analysis, and communication of
safety data is advisable. At the same time, it is critical
to remember that patient centricity is more about
listening, communicating, and disseminating information
to the patients (which will ultimately empower them to
participate in the decision-making process), and not
about putting the decision making solely in their hands.
Communication
Insights
gathering
Engagement
Budget
Pre-trial Trial startup During trial Trial closeout
and post
Limited outreach
and awareness
of trial and its
intent
Cumbersome and
limited, e.g., consent
process and trial
objective, procedures
not clearly conveyed
Limited
communication
directly from sponsor
company, e.g.,
participant newsletter
Limited communication directly from
sponsor company, e.g., trial summary
and outcome. Companies are piloting
result disclosure and lay language
summaries
N/A Not part of current
standard practice or
processes
Not part of current
standard practice or
processes. Cumbersome to
execute direct sponsor-to-
participant communication
due to approvals by
ethic commitees and
international review boards
Not part of current standard
practice or processes, e.g.,
post-trial network
Not a line item in
the trial budget
Limited funding Limited and late
funding
Limited funding, often not a
line item in the trial budget
Source: Kenneth A Getz, Patients as Partners Conference
Not a part of a current standard practice, but companies are piloting various approaches

3. RWE and Market Access
Demonstrating the value of a drug through a
comparative analysis to existing treatments is essential
in empowering patients to make informed decisions.
Patient-centric RWE and market access activities create
meaningful value-based evidence for physicians,
patients, regulators, and payers by developing global
and/or local dossiers, economic models, and publications.
These tools can be used to help demonstrate the value
proposition of a product utilising clinical, economic,
and observational data. Armed with this information,
patients and payers can better manage budgets and
estimate the benefit-risk comparison of interventions.
Life sciences companies are better able to understand
the treatment landscape with respect to comparators
and outcome measures, stakeholder needs, and payer
value drivers across different markets and the product
lifecycle.
Payer perspectives can influence patient access, and
patient perspectives can drive utilisation. In the US,
payers are increasingly encouraged via initiatives (e.g.,
the IHI Triple Aim) to embark on deeper collaborations
with the pharma industry and consider RWE from sources
such as value assessment frameworks.
To support the involvement of patients, the 21st
Century
Cures Act and the re-authorisation of the Prescription
Drug User Fee Act emphasise the use of patient outcome
data for drug development. Patients can make more
educated health decisions based on information from
the Patient-Centered Outcomes Research Institute,
National Health Council, virtual networks, and digital
technology such as mobile health (mHealth).
Although an emerging area of post-market access,
mHealth is starting to be employed in the US. For
example, Johnson Johnson collaborated with Aetna
to use wearable technology in atrial fibrillation (AFib)
screening for RWE generation (3). They were able to
identify people with asymptomatic AFib earlier
and more efficiently than from routine care. Health
PROMiSe, a patient reported outcome tool integrated
with electronic health records, helped inflammatory
bowel disease patients and providers to visualise
real-time data; therefore, improving their quality
of life (4).
Late phase and Phase IV studies (non-observational
and observational) are a key source of engagement with
patients, monitoring outcomes, safety, and effectiveness
at the individual patient level.
Patient Support
Historically, not all life sciences companies have
had lots of direct communication with patients, some
relying instead on other stakeholders such as payers,
As patients are taking more
interest in their health and healthcare,
they support the maxim of ‘nothing
about me, without me’
Image:©Pixabay
28 ICT l www.samedanltd.com

4. Susan Najjar has over 25 years of
industry experience with several years
in senior leadership and consulting
positions. Prior to joining Sciformix,
a Covance company, Susan oversaw
global marketing activities for Thermo
Fisher Scientific’s informatics division,
developing growth strategies and implementing innovative
marketing programmes. Prior to Thermo, she was
accountable for establishing the Gillette Company’s
North American Blades and Razors forecasting and
planning, executing software product launches at Sun
Microsystems, and consulting senior pharma executive
teams at Deloitte Touche. Susan has an MS in
Biochemical Engineering from Tufts University, US, and
an MBA from MIT Sloan, US.
Email: susan.najjar@sciformix.com
About the author
pharmacists, and physicians to gather feedback and
provide information. Establishing closer relationships
with these stakeholders and patients can be beneficial
in supporting adherence to treatment and better
outcomes, thus realising the commercial potential of
a treatment. Customer-centric fields and call centre
services that enable life sciences companies to directly
support patients and stakeholders are essential elements
of a patient-centric organisation.
Reimbursement/Financial Support
Depending on the region, patients can struggle with
complex reimbursement processes or may even be
uninsured. By providing reimbursement and financial
support services to patients and doctors, life sciences
companies can facilitate access to their treatment for
those who need it.
Patient Experience Analysis
By employing patient experience programmes,
organisations obtain feedback from patients so they can
understand what aspects of the patient experience may
negatively impact outcomes and provide assistance or
solutions to improve them.
Adherence Support
Patients may suffer stress or anxiety in relation to
their treatment or condition, or may be on a complex
treatment plan. Delivering support to encourage
adherence can improve outcomes and build trust.
HCPs and Field Support
Educating and collaborating with HCPs to deliver
more effective treatment to their patients is critical
in achieving market success. Supporting patients
directly by answering questions about their treatment
and providing information can also help take the
strain off of time-poor HCPs. However, developing
closer links to patients, HCPs, and other stakeholders
is important so that every person involved in a patient’s
journey is well informed and better able to support
that patient throughout their treatment.
Other support during the post-marketing phase
that helps contribute towards patient centricity
includes:
• Payer relations: providing payers with on-site,
hands-on help with billing, pharmacy interactions,
affordability, and other issues shows your commitment
to supporting product access
• Clinical outcomes assessments: with patients
increasingly having to pay for innovative treatments
themselves, the importance of strong clinical outcomes
evidence is growing
Adopting a Patient-Centric Model
As patients are taking more interest in their health
and healthcare, they support the maxim of ‘nothing
about me, without me’ and expect caregivers to
engage in shared decision making. When it comes
to developing and launching new treatments, life
sciences companies are realising the importance
of building patient centricity into the entire
product lifecycle.
It is widely reported that patients who have more
control over their treatment tend to have better
outcomes. There are clear commercial and health
benefits to adopting a patient-centric model. This
can only be achieved by collaborating with diverse
stakeholders in the healthcare ecosystem and
finding the right partner for the whole patient
journey from development, trials, and launch to
post-market support.
References
1. Visit: www.ipsos.com/sites/default/files/ct/publication/
documents/2018-09/ipsos-healthcare-the-path-to-patient-
centricity-august-2018.pdf
2. Visit: www.appliedclinicaltrialsonline.com/practical-overview-
patient-centric-trials
3. Visit: www.jnj.com/media-center/press-releases/new-late-
breaking-study-finds-wearable-electrocardiogram-ecg-
monitoring-patch-can-detect-atrial-fibrillation-earlier-and-
more-efficiently-than-routine-care
4. Atreja A, Impact of the mobile HealthPROMISE platform on the
quality of care and quality of life in patients with inflammatory
bowel disease: Study protocol of a pragmatic randomized
controlled trial, JMIR Res Protoc 4(1): 2015
30 ICT l www.samedanltd.com