This document includes three blog posts recently featured in PharmaVOICE. The blogs focus on how enhanced access to in-depth health data is impacting an understanding of personhood, the environment around us, and the pharma operating model. BLOG 1 (Pages 2-7) Waves of Real Life Data Are Inundating Pharma...Can They Keep Up? BLOG 2 (Pages 8-13) Better understanding where and how we live will vastly improve remote patient monitoring approaches BLOG 3 (Pages 14-18) 5 Ways Pharma Can Be More Patient-Centered & Usher in Digital Transformation Send me a note with your comments and feedback. Thanks for reading!

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This document includes three blog posts recently featured in PharmaVOICE.
The blogs focus on how enhanced access to in-depth health data is impacting an
understanding of personhood, the environment around us, and the pharma
operating model.
BLOG 1 (Pages 2-7)
Waves of Real Life Data Are Inundating Pharma…Can They Keep Up?
BLOG 2 (Pages 8-13)
Better understanding where and how we live will vastly improve remote patient
monitoring approaches
BLOG 3 (Pages 14-18)
5 Ways Pharma Can Be More Patient-Centered & Usher in Digital Transformation
Send me a note with your comments and feedback. Thanks for reading!
- Carlos Rodarte
Founder & Managing Director
Volar Health, LLC
carlos@volarhealth.com

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Part 1: PharmaVOICE Blog Post
Waves of Real Life Data Are Inundating Pharma…Can
They Keep Up?
June 8, 2018
by Carlos Rodarte, Founder & Managing Director, Volar Health, LLC
This is part one of a three-part series that will discuss how enhanced access to in-
depth health data is impacting our understanding of personhood, the environment
around us, and the pharma model.
A New Understanding of Personhood
Our understanding and perception of health and disease is shaped by the data that
we have available to us. This is true for the individual searching Dr. Google, an urban
informaticist measuring the impact of a proposed mixed-use development, or the
prototypical researcher on the hunt for the elusive but groundbreaking medical
discovery.

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As a society we uncovered previously hidden pathogens causing virulent diseases to
creating personalized therapeutics in breast cancer based on mutation status. The
data and methods underpinning these discoveries now appear obvious, particularly
as they have become mainstream. And now, there is yet another paradigm forming
that will impact how health and disease are defined, how interventions are
assembled, and how individuals are engaged.
What’s driving the shift? It’s the data – and everything that extends from it. We’ve
long known about the complexity of human behavior and the many factors that
influence health, but only recently has data generation centrally focused on the
person. To ensure we start seeing the previously hidden facets of our lives, we’ll
need to also see processing and algorithmic improvements, greater specificity on the
problems we’re solving, and amplify the insights that are generated. Done well,
these insights enable self-discovery while also improving the population as a whole.
Health’s Digital Mirror Image
While the inpatient setting will continue to create a certain type of clinical healthcare
data, we know that everyday situations and lived experience drive health outcomes
in many cases. Through a variety of means, we are now able to collect, analyze, and
act on heaps of “real life” data that have been applied to health.
There is certainly going to be a lot of “noise” when casting a net wide enough to
encompass all aspects of our life, but we are seeing more and more traditional
health and disease concepts reflecting themselves in our digital world.
Our New Digital World
Phenotype –> Digital phenotype
Biomarkers –> Digital biomarkers
Therapeutics –> Digital therapeutics

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Technology and sensors in particular are not only bridging the inpatient and
outpatient setting, but the digital and non-digital world. For example, digital versions
of phenotype, biomarkers, and therapeutics have given rise to new models of virtual
research and remote care.
Today there are initiatives to understand and measure health and disease in a more
holistic way as well – a “full stack” model that elucidates relationships amongst data
that were previously unknown, or hypothesized, but yet not computable.
One such example is the One Brave Idea project in cardiovascular disease, a next-
generation Framingham heart study with additional data inputs such as patient-
generated health data (PGHD) and environmental factors, alongside more advanced
analytic capabilities. This project required a unique partnership model including
AstraZeneca, American Heart Association, and Verily – each bringing a unique set of
perspectives and capabilities.
These increasingly prevalent projects and partnerships are adding sophistication to a
field historically viewed as needing more robust evidence. Startups, for example, are
running more studies; and, regulators, such as the Food and Drug Administration,
(FDA) are starting to join the national discussion, and in some cases providing much
needed guidance.
The Needle in the Haystack
Techniques to capture objective data from digital devices are emerging, as are the
applications of digital biomarkers. In order to make the best use of the data, we
have to understand the person in a great level of detail (digital biomarkers) in the
context in which they reside (social ecological model).
The ability to toggle between these two frames of reference opens the opportunity
to look at various patterns, relationships, and biases.

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[Left Image: Digital Biomarkers Journal. Source: Digital Biomarkers. Right Image: Social
Ecological Model – Center for Disease Control (CDC) for Colorectal Cancer. Source: CDC.
Digital biomarkers may shed light into how gait in Parkinson’s disease can elucidate
disease progression and treatment effectiveness, but in isolation, without a sound
social ecological model such innovation is unlikely to have a broader impact.
These micro and macro frames also help us ensure we’re being representative with
our research to enable personhood across the board. The promise to improve the
health of large cohorts with smart data sets and analytical rigor in part depends on
ensuring that there is a representative population to draw from. As was stated
earlier, our understanding of health and disease is shaped by the data that we have
available to us; but the availability of these data increasingly hinge on gaining access
from the individuals who generate it.
There are skews in the population that have been whole genome sequenced or who
can afford next-generation sensor tools to measure their health. Going forward, it is
everyone’s role, and particularly those designing studies and methods, to ensure
there is an appropriate level of representation and diversity included – whether it be
ethnic, sexual orientation, socioeconomic status, etc.

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What is pharma’s role?
Pharma is ultimately in the business of discovering, developing, and launching new
interventions based on an increasing knowledge base of how disease manifests and
how individuals behave. The use of real life data, for example – patient-generated
health data (PGHD) that companies like Validic enable, opens up several
opportunities across the pharma value chain.
Through this, pharma is in a position to know much more about the needs of
patients, and as such, pharma has a responsibility to reflect back to patients’
learnings that arise. A few examples where pharma can apply novel forms of data
with the potential to simultaneously help individuals learn more about themselves.
Research
Understanding the progression of disease and determining the factors that influence
treatment outcomes is a need for pharma. The digital phenotype is increasingly
quantified and, as a result, computable—whether it be from a human behavior
standpoint or detailed physiology. The meshing of patient-reported outcome
measures (PROMs) with new sensor streams will further increase computational
models that reveal new subtypes of disease and responders. This opens up
opportunities to engage patients more empathetically in their care and in research
studies. A publication titled Building a learning health community: By the people, for
the people, does a nice job of itemizing the principles that should be considered
when building patient-centric health measures – ensuring that the measure is clear,
that it respects people’s time, is harmless, and is ultimately actionable, to name a
few.
Development
The use of digital endpoints is part of a much larger effort to digitize the entire drug
development process, and these endpoints will have a pronounced impact on how
patients are engaged and how trials are conducted. For example, the six-minute walk
test (6MWT) can be greatly enhanced in controlled, in-clinic environments to include
measures of gait and balance, while modified versions assisted with remote
technology can be conveniently deployed in outpatient and home environments.
The Clinical Trials Transformation Initiative (CTTI) has a long history of bringing
cohesion to efforts that aim to modernize clinical trials.

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Commercialization
Determining who needs a particular intervention and whether that intervention is
working in the real world can be analyzed in entirely different ways. Rather than
over-relying on billing and claims data to identify needs and assess drug
effectiveness, geography and social determinants of health, for example, enable a
new, more accurate calculus. In addition, after a drug’s launch, there may be
observational studies that are initiated, and these types of studies are particularly
exciting as the number of observations that can now be made are much greater than
to what we have been accustomed.
The Future
As pharma continues to answer these questions and build internal infrastructure to
accommodate novel and disparate data sources, organizations will encounter many
additional challenges. These challenges will be technical in some cases,
organizational in others, and everything else in between. Part two and three of this
series will go deeper into quantifying our everyday environments and the smart
home, and the future data-heavy pharma model.
If you are interested in learning more about digital health’s implications in
pharma, download the industry report on the implications and considerations for
digital health devices and data in clinical trials.
Carlos Rodarte (@crodarte) is founder and managing director of Volar Health LLC, a
digital health strategy consulting practice enabling a range of innovators to better
utilize novel data sources to enhance their products and services. Disclosure: Carlos
Rodarte is on the editorial board of Digital Biomarkers; Volar Health, LLC has a client
relationship with Validic.
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Part 2: PharmaVOICE Blog Post
Better understanding where and how we live will vastly
improve remote patient monitoring approaches
June 20, 2018
by Carlos Rodarte, Founder & Managing Director, Volar Health, LLC
This is part two of a three-part series that discusses how enhanced access to in-depth
health data is impacting our understanding of personhood, the environment around
us, and the pharma model.
Our Environment, Decoded
Depending on who you are speaking with, the word “environment” may be viewed
from different lenses – some may see this as the naturalist, as the physical
environment/exposome, as a built environment, or even the context of our everyday
lives that include social and behavioral determinants of health. Let’s also not forget
the tech-focused person that will view the environment through the lens of the
connected world of Internet-of-Things devices.

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Such perspectives will influence the way we find solutions to patient’s needs. For
example, when we think about improving patient outcomes, our minds tend to
naturally focus on treatments which have been prescribed, clinically-focused
outcomes, drug adherence rates, and a host of other medical factors. This is both
expected and part of the problem. In reality, where we live – and how we live – will
often play a more influential role on our health than we typically ascribe to it. This
notion is by no means new – it forms the foundational pillar to many disciplines
including sociology, public health, and urban studies, to name a few.
Innovation in healthcare and pharma should not begin with a technology in mind but
rather with a specific question and a particular mindset.
“How might we begin to understand, address, and modify the various environmental
factors, broadly defined, that influence health and disease in order to improve the
wellbeing of individuals?”
A relatively recent report titled Zip Codes Alone Don’t Deliver, which was further
highlighted in a Health Populi blog, discusses the role that socio-behavioral
determinants of health (SBDoH) play across populations. This is a step up from purely
acknowledging “social” determinants of health, but this still does not emphasize
critical physical/built environmental components.

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Responsive Living & Next-Generation Measurement
In Part I of this series, we discussed a new notion of personhood based having a more
comprehensive view of a person’s behavior. Devices that are worn on our bodies or
that we carry around with us emit lots of information that is indicative of our health
status. While social and behavioral factors certainly modulate health and disease, so
does the amount of light we are exposed to, the air we breathe, or the temperature
we experience, to name a few (see below).
[Source: Volar Health, LLC]
Altering the weather patterns and ambient conditions of our cities to generally
improve health is a huge and separate type of effort; our homes, on the other hand,
are much more under our control.
According to some estimates, we spend upwards of 90% of our time indoors and
researchers are taking note of how building health is intimately linked to human
health. Simultaneously, large tech companies like Apple are fully diving into the
smart home movement with the goal of improving comfort, convenience, and
livability.
Let’s take a closer look at the Apple Home Ecosystem.

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[Source: https://www.apple.com/ios/home/]
On first blush, the Apple Home ecosystem aims to make individuals more
comfortable and relaxed, while also providing “peace of mind” with security
features. The intent is not to explicitly impact health, though parts of the ecosystem
clearly hit on social, behavioral, and physical factors that do impact health and
disease. The home environment is on the front lines of health and disease
management.
Where Does Remote Patient Monitoring (RPM) Fit In?
Health systems and payors have been implementing remote monitoring programs
for many years. The inpatient setting is costly and the promise of RPM approaches
are attractive. They enable patients to stay in their homes and maintain their social
ties, while being monitored with clinical-grade technology as needed. In
addition, providers can now be reimbursed for providing such services in certain
cases.
This latter part is a game changer because it means that RPM solutions can now
expand beyond serving solely high-risk patients who have high-cost care. While there
are examples or RPM solutions being implemented for management of a wide gamut
of diseases, it also has the ability to address our aging population and
enhance aging-in-place.
While stakeholders involved in care delivery shift the care to the outpatient setting
and to people’s homes specifically, these same stakeholders are scrutinizing the
costs of all the components of a patient’s care, including drug prices.
This is where pharma enters the picture. Remote patient monitoring unites
stakeholders around the patient, the home, and forms of real-world evidence.

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Pharma is engaged in various initiatives to get a better sense of their treatment’s
real-world effectiveness in a greater context that involves RPM, smart homes, and
the types of communities that people live in. There are some areas that represent
“low-hanging fruit” such as respiratory diseases, allergies, and others where
environmental parameters trigger well-defined events.
A clear example is the work of Propeller Health in the respiratory space. They have
inked partnerships with leading pharma and more recently they also made available
an API called Air to better characterize asthma conditions in various neighborhoods.
The data that emerges from RPM programs represents a rich source of potential
evidence on how patients are managing their disease, how their behaviors are
changing, and the role of environment. Risk-based contracts or outcomes-based
reimbursement models between payors and pharma will undoubtedly need to
include novel data sources from Internet-of-Things devices, aspects of the medical
home of the future, and other innovative data sources to come. To date it has been
challenging to deploy RPM approaches with ease, but this is beginning to change.
For example, Validic has recently launched a lightweight remote patient monitoring
solution called Impact. The solution makes it easy for various stakeholders to deploy
RPM programs with their own clinical workflows, the devices of their choice, and the
ability to capture meaningful contextual data.

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The Future
We are early in our understanding of how data streams that emanate from various
environments will impact how research is done and care is delivered. What is known,
however, is that our sensor-embedded environments will increasingly modulate and
guide, not just impact, our behaviors.
While it is probably a stretch at the moment that pharma will prescribe “therapeutic
environments” instead of drugs, pharma is taking note of the various aspects of our
everyday living that impact disease and outcomes and opportunities it means for
“real-world evidence.”
Stay tuned for part three of this series where we will provide some specific
recommendations on how pharma and the rest of the health ecosystem may work
together.
Carlos Rodarte (@crodarte) is founder and managing director of Volar Health LLC, a
digital health strategy consulting practice enabling a range of innovators to better
utilize novel data sources to enhance their products and services. Disclosure: Carlos
Rodarte is on the editorial board of Digital Biomarkers; Volar Health, LLC has a client
relationship with Validic.
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Part 3: PharmaVOICE Blog Post
5 Ways Pharma Can Be More Patient-Centered & Usher in
Digital Transformation
August 6, 2018
by Carlos Rodarte, Founder & Managing Director, Volar Health, LLC
This is part three of a three-part series that discusses how enhanced access to in-
depth health data is impacting our understanding of personhood, the environment
around us, and the pharma model.
Focusing on What Matters
The success of any industry is predicated upon that industry’s ability to effectively
meet the needs and expectations of its customers. Only until recently has the
pharmaceutical industry gained a true appreciation for the needs of its real
customers – not the payors, but patients.

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In Part one and Part two of this series we discussed the increasing relevance of ‘real-
life’ data and how it can help us better understand both the individual patient and
the everyday situations that impact health and disease. However, bringing these new
insights and learnings into pharma’s historically rigid drug development and
commercial model is not without its challenges.
While a review of the various types of organizational models that may present
themselves within pharma would take us in a very different direction, it is clear that
pharma is continuing to shift toward a model where patient needs increasingly drive
all operations (see figure below).
With a need to become more patient centric, data savvy, and digitally forward,
pharma has been making decisive moves over the years to reinvent itself. Leaders in
the industry have been partnering with various patient engagement companies, on
occasion making large equity investments in startups, and even acquiring more
mature companies that align to their portfolios.
With so much change in the air, what should pharma continue to emphasize?

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Five Activities That Will Propel Pharma Forward
1. Articulate a Patient-Centric Vision. Pharma companies are matrix organizations
that behave in complex ways. This complexity in part reflects the various capabilities
that keep the entire engine running. However, because there is such deep
specialization within companies, CEOs and executives must communicate and
reinforce a common vision and look to highlight individuals that embody the
elements that the company is striving for. Importantly, this involves having longer-
term thinking and rewarding innovative thinking (and the failures that undoubtedly
will happen through rapid experimentation).
2. Invest in Cohesive Internal Platforms. Pharma operates on a pendulum that
swings between largely innovating internally and innovating externally. As new
technologies, for example, present themselves, pharma may create an innovation
hub around these tools – but much of the experimentation and implementation of
new tech is guided by Contract Research Organizations (CROs). Only after pharma
realizes that this new future paradigm might take hold – for example, one where the
effective use of patient-centric technologies is paramount to success – does it begin
to build up its internal capabilities. For example, today we’re beginning to see this
shift take place in the area of digital endpoints. This is fueled by a combination of
factors, including the creation of regulatory frameworks and cross-stakeholder
initiatives like those by Clinical Trials Transformation Initiative (CTTI).
3. Identify Opportunities to Digitize. Digital phenotypes, digital biomarkers, and
digital therapeutics were all discussed in part one of this series, but it’s worth
emphasizing that the point of digitization is both to increase the ability to capture
meaningful data, and to improve the patient experience. This includes trials
leveraging remote patient monitoring elements that reduce the burden on patients
to need to drive long distances to physically connect with their doctor. Today,
pharma is beginning to see the value in the utilization of such digital tools that can
improve patient experience and, in turn, garner more accurate, insightful trial
results.

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4. Create Bridges to Care Environment. By utilizing digital biomarkers and partnering
with digital therapeutics companies, pharma is increasingly altering the care delivery
environment. Digital therapeutic partnerships between startups and large pharma
are gaining momentum and are especially advantageous at a time when pharma is
under pressure to justify that its interventions are moving the needle on outcomes.
The behavior change element that underpins digital therapeutics serves the added
benefit of better engaging patients, motivating where appropriate, and providing
deeper levels of human interaction. What better way to enhance its position in the
outcomes-driven world than enabling more holistic interventions?
5. Build Trust With… Everyone. Every part of the pharma operating model can
improve its level of transparency and create more trustworthy relationships with
patients, researchers, governments, and other healthcare stakeholders. This requires
more open science initiatives, greater sharing of data, more transparency around
drug pricing, and ultimately aligning the success of the pharma operating model to
patient value. Risk-based contracts will have a leveling effect where high-priced
medications are mitigated by lower cost, and effective, digital therapeutics, for
example. This world is coming, and in many ways it’s already here – further
reinforcing the importance of pharma’s ability to take an active role.
The Future
Every part of the pharma operating model is undergoing its own mini-revolution. The
way in which drugs are being discovered now involves novel data sets and analytical
methods that were not around 10 years ago. Trials are digitally enabled and
increasingly virtual. And, patients-as-consumers are demanding more patient-centric
experiences that pharma is not accustomed to providing. This means that social
determinants of health and other “life” factors need to be increasingly accounted
for. There is much change happening simultaneously.

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For this reason, pharma cannot simply make small, incremental steps towards this
future, but rather must strategically reconsider all parts of its operating model in
order to stay relevant. As healthcare, and the technology that supports it, continues
to evolve, pharma must take serious steps to keep pace and use the data and
solutions available to create a more patient-centric experience that can ultimately
provide more meaningful, solutions.
Carlos Rodarte (@crodarte) is founder and managing director of Volar Health LLC, a
digital health strategy consulting practice enabling a range of innovators to better
utilize novel data sources to enhance their products and services. Disclosure: Carlos
Rodarte is on the editorial board of Digital Biomarkers; Volar Health, LLC has a client
relationship with Validic.
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