OPINIÃO E DEBATE

BIG DATA OPPORTUNITIES IN HEALTHCARE.

HOW CAN MEDICAL AFFAIRS CONTRIBUTE?
AS OPORTUNIDADES DOS BIG DATA NOS CUIDADOS DE SAÚDE.
QUE CONTRIBUTO PODEM DAR OS ASSUNTOS MÉDICOS?

José Aleixo Dias

MD, MSc Epid, MBA, Medical Director, Pfizer Biofarmacêutica, Lda., Invited Auxiliary Professor, Aveiro University

Paulo Duarte
MBA, Multichannel Marketing Lead, Pfizer Biofarmacêutica, Lda.

Abstract
The topic of Big Data has been gathering more and more attention, namely in the healthcare sector. Recen-
tly, while participating in a conference where this topic was extensively discussed1, it became clear that
there is still need for awareness around the evolution and opportunities associated with the management
of large datasets and how the information generated from these sources can change our lives. Big Data has
the potential to transform medical practice by integrating different data sources and making use of real
time data, to increase patient´s involvement and improve the efficiency of care. Some major challenges are
30
related with understanding its value, ensure security and governance in a way that research, health-care
management and patient’s outcomes can be improved. One thought it could be helpful to bring up this
discussion to a larger audience, focusing on two main dimensions: the potential impact of Big Data on
healthcare and the specific contribution of Medical Affairs (MA). On this regard MA can raise awareness,
stimulate adoption of digital tools and electronic data management, support partnerships while mitigating
potential safety and commercial risks.
Keywords: Big Data, Medical Affairs, healthcare, governance, patient’s outcomes.

Resumo
O tema «Big Data» está na ordem do dia, atraindo a atenção das mais variadas áreas, nomeadamente do setor
da saúde1. Porém, o conhecimento sobre a evolução alcançada, bem como as perspetivas futuras, carecem
ainda de ser aprofundados. De facto, as reais potencialidades associadas à gestão coordenada de grandes
bases de dados que permitam integrar de forma compreensiva os elementos sobre a saúde de cada um de nós
ainda geram desconfiança e receio. De salientar o papel do cidadão na gestão da sua própria saúde, através
da monitorização de um conjunto alargado de parâmetros biológicos, e a relevância deste assunto para as
entidades que desenvolvem atividades no domínio da investigação clínica e de dispositivos médicos, bem como
para as autoridades de saúde. Para que tudo isto seja possível, importa assegurar uma gestão coordenada e
segura dessa informação, assim como acordar numa legislação robusta mas pragmática e no reconhecimento
do seu valor acrescentado para a gestão do sistema de saúde e para o bem-estar dos cidadãos. Os Assuntos
Médicos da indústria farmacêutica podem dar aqui um contributo essencial, nomeadamente nos domínios
da sensibilização para a adoção da gestão digital de dados e de aplicações de saúde, particularmente no
âmbito da investigação, harmonização e compatibilidade dos sistemas, diferenciação face aos processos
convencionais, estímulo a parcerias e minimização dos riscos de segurança e comerciais.
Palavras-chave: Big Data, Assuntos Médicos, cuidados de saúde, governança, resultados dos doentes.

Rev Port Farmacoter | 2015;7:230-236


The Big Data Concept
At the beginning this concept was associated with
the collection and analysis of large amounts of data. A
dataset is considered big if it ranges from a few tera-
bytes to many petabytes2. A byte is a basic unit of
information containing 8 bits, which can include 28
or 256 values. Currently, it describes how using the
evolving technology, this vast amount of data trans-
lates into information and knowledge about the laws
of nature, genomics and human behavior, which can
be used in monitoring, predicting and planning.
Big Data in Health
It was already 70 years ago that the computer entered
our lives. This helped the collection and organiza-
tion of data that has grown exponentially since then.
Though it was mainly focused on data mining during
the eighties and nineties, business analytics, customer
relationship and healthcare management, brought us
to a new development stage. The current amount of
data being collected and stored is vast and expanding.
We see a widespread uptake of electronic health records
and a certain “chaos” on how to manage them. Some
of these records contain quantitative data. However,
about 80% of the data is qualitative and registered in
an unstructured format (text based).
Together with massive improvements regarding
the decision making process, disease prevention
and Healthcare monitoring, significant challenges
also arise. These are mainly related with complex-
ity (compatibility, readability, reliance) and data
privacy concerns. The technological advances have
change the way we collect, analyze and store data,
transforming a complex process into an easy solu-
tion. But the challenge is to combine all the available
sources in an organized way, allowing for its usage
in real time and extract information that may lead to
meaningful decisions.
Big-Data Revolution
After collecting data for so long, some critical ques-
tions remain to be answered, such as:
• Why do we need to collect and store such large
amounts of data?
• Who is analyzing all that information?
• For which purposes?
• Who is ensuring the security and reliability of such
information?
• What is the added value for the patient and for the
healthcare system?
OPINIÃO E DEBATE
The coordination of efforts between Healthcare
Providers and Pharma Industry could gain momen-
tum and be used to ensure better health outcomes.
An important part of this goodwill is lost during
the patient’s journey3. A more collaborative model
between stakeholders will ensure the added value
brought by innovation and the commitment to pro-
vide better health to our population.
Figure 1 – The innovation cycle
1.
Demand
5. 2.
Data Mgt Supply
4. 3.
Innovation Technology
31
4
Adapted from McKinsey analysis .
1. Demand for Better Data and Insights
There’s a huge pressure from governments and pay-
ers on cost containment measures. Pharma wants to
make a more efficient use of the available data to bet-
ter understand disease distribution, safety patterns,
and patient’s compliance and to evaluate product im-
pact and health outcomes. In this process, patients
are being more empowered while involved in moni-
toring their own health. More and more patients are
digitally skilled and willing to play a role in this op-
timization process. While sharing their experiences,
they provide relevant insights that can be used to fos-
ter research and improve health outcomes.
2. Supply and Governance of Relevant Data
Data sources are increasing and regularly used by a
great variety of stakeholders. Several devices such as
wearables and software are collecting data that could
be of relevant use in healthcare management. How-
ever, it is frequently unclear who is managing it, if
this is stored? Where? For which purpose? Despite
a large number of potential users, the lack of confi-
dence on what will happen to personal data remains
to be clarified.
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 OPINIÃO E DEBATE
3. Technology – Data Sharing
New players are becoming more important, while
new companies are emerging and taking on a new
and important role in the Healthcare environment.
Technology is more and more friendly, easy to use
and readily available. Despite security and integra-
tion challenges most companies are favorable to data
sharing and collaboration3.
4. Innovation & Co-creation
There are a lot of players in managing health tech-
nology and Healthcare data. Customer insights and
unmet needs are being screened and analyzed by cre-
ative companies and startups, to develop new ways
of collecting patient’s health outcomes and respond
to unmet medical needs. Innovation can be the result
of bringing complementary parties together (co-cre-
ation), in order to jointly produce a mutually valued
outcome.
5. Data Management & Legislation
The technology screening and regulation should be
improved in the future, allowing for better decision
32 making process for both patients and Healthcare
providers. Appropriate and pragmatic legislation
is needed for data protection, data storage and data
analysis.
The Example of Managing
our Own Health
How much time out of the 8760 hours of a year, do
we dedicate to evaluate and monitor our own health?
For most people, perhaps only a couple of hours at
the outmost, if one has considered booking a yearly
check-up, and some additional exams.
Physicians hold patient’s health records but are these
being managed in a way to monitor some health in-
dicators regularly like: weight, blood pressure, heart
rate, medication, treatment compliance, vaccination
or physical activity? If one has a chronic condition
like asthma, is this person being alerted for the pol-
len’s level in advance, so that, one can take appropriate
preventive measures? Is our heart function or glycemic
control being regularly assessed? Suppose instead that
our physician had timely access to our physical activ-
ity, our glycaemia or microbiome, etc… then, recom-
mendations would be personalized, early diagnosis
could be more often made and prevention of complica-
tions could be more promptly implemented.
Medicine was ahead of many other areas in recogniz-
ing the value of data, to support the decision making
Rev Port Farmacoter | 2015;7:230-236
process. However, technology is quickly evolving and
healthcare has lagged in adopting techniques to lever-
age the rich information contained in these databas-
es, namely in a coordinated way. Despite the growing
tendency for the use of real world data (RWD) gen-
erated both from field studies and registries, as well
as, the concomitant proliferation of structured data-
bases, a large amount of health or disease related in-
formation is still of unstructured or semi-structured
nature. That is the case of patient’s files, namely in
what concerns complementary exams reports.
In Portugal, examples of data used in Oncology Reg-
istries5, Cardiology Registries6 or Rheumatology
Registries7 are collected from several sources, vali-
dated, coded and structured before being uploaded
into the systems. However, this requires reading and
interpretation before processing, once most of the
data is semi or unstructured at origin.
The complexity of adapting these data has to do with
the nature of the information, once this could be
based on numbers, text, graphs or images. Recent ad-
vances in technology such as Hadoop MapReduce8 or
tranSMART9 make it possible. However the chal-
lenge resides on how to extract knowledge from
them.
The “Six Vs” to Value
Certain authors highlighted the Big Data character-
istics in “three Vs”: Volume, Variety and Velocity10. Oth-
ers proposed adding a fourth dimension11,12: Veracity.
Reflecting on these, we are proposing not 3 or 4 but,
6 dimensions:
1. Volume
The amount of Big Data generated and stored across the
World in 2012 was said to be over 3500 petabytes (1015)
in the US, while above 2000 in Europe. However, more
recent estimates point to at least 5 zettabytes (1021),
potentially growing to 35 zettabytes by 202012.
2. Variety
There is a large variety of channels supporting elec-
tronic interactions. Last year 42012 million of porta-
ble health monitors were sought to operate, mostly in
three different manners:
- People to people – networks, virtual communities, we-
binars/WebEx’s;
- People to machine – archives, computers, mobile ap-
plications;
- Machine to machine – bar code scanners, monitor de-
vices, scientific research.

3. Velocity
The speed of data transfer is incredible high. Around
the World, about 3 million emails10 are sent every sec-
ond, while in YouTube 20 hours of video are stored
every hour and 50 million tweets are exercised per
day.
4. Veracity
Despite its many advantages, a large amount of data
cannot guarantee accurate results, unless quality is
ensured. The poor quality of the data is estimated to
cost 3,1 trillion11 dollars a year in the US, while deci-
sions are frequently taken with large uncertainty on
the quality of the data they were based upon.
5. Versatility
Concerns the capability to adapt and flexibility to
use available data generated through the different
systems. It requires availability and compatibility.
6. Viability
Is the data accessible and available to be used, both
by personal consent and by law? While processing
and protecting the right to privacy, one should not
avoid technological progress and innovation which
could be useful to people.
The combination of these six dimensions leads to = VALUE
The opportunities are no longer bound only to data
capture and management but on how data are col-
lected and analyzed to create value, having in view
disease prevention and precision treatments.
The Value of Big Data in Healthcare
Big Data is a big opportunity to develop patient driv-
en outcomes, and sustainable models of healthcare
delivery, to maximize the potential of scientific de-
velopments.
Experts provide their perspective on how one can
use Big Data in a manner consistent with patients’
rights, to improve healthcare systems to that end. The
European Federation of Pharmaceutical Industries
(EFPIA) considers that a focus on outcomes can ad-
dress many current healthcare challenges13. Systems
are struggling to spend their money where it has the
highest impact and Big Data might help these systems
to allocate spending where it really makes a differ-
ence. However, there is a risk that overly-restrictive
data privacy laws and consent requirements could
OPINIÃO E DEBATE
adversely affect our ability to realize the potential of
Big Data for research, especially in healthcare. By fo-
cusing on interventions that really work and moving
away from those that don’t, we can improve health and
make health systems more financially sustainable. The
Big Data strategies to better inform decision making
could generate high savings in the healthcare system,
by optimizing innovation, improving the efficiency
of research and clinical trials, and building new tools
for physicians, consumers, insurers, and regulators to
meet the promise of more individualized approaches.
This opportunity is driving Healthcare providers in
complex business environments experiencing a grow-
ing trend in the types and volumes of available data.
The healthcare data growth is generated from several
sources, including the R&D process itself, retailers,
patients, and caregivers.
Big Data in Pharma
The uses for Big Data in Pharma are limitless. Clini-
cal, Commercial and Market Access teams can all
benefit from Big Data insights. Most important ob-
jectives being:
- Understand and assess patient needs; 33
- Develop better clinical targeting, once the end-
point measures of human physiology are no longer
enough to guide the new generation of medicines and
to evaluate drug response;
- Gather Patient Related Outcomes (PROs);
- Explore sensor technology to further contextualize
disease and drug response through continuous phys-
iological readouts;
- Develop better payer messaging;
- Develop better market segmentation.
Part of taking advantage of Big Data involves making
data capture as electronic as possible. Companies are
increasingly using electronic systems of capturing
and transmitting PRO responses by using comput-
ers, tablets and mobile devices to record patient an-
swers. Recently FDA approved a PRO-Diary for use
as a medical device worn on the wrist and used to
record patient data. This approval will drive its use
in clinical trials as a way to collect PROs quickly and
more reliably from the patient. These and similar de-
vices will improve data capture and increase datasets
to yield more reliable results.
Big Data applications vary slightly among pharma-
ceutical companies and consultants. Pharma compa-
nies are more likely to focus Big Data initiatives on
current products to grant the success of drugs already
Rev Port Farmacoter | 2015;7:230-236
 OPINIÃO E DEBATE
on the market14. Consultants are more likely to con-
tribute to the development of new products. Overall,
the prevalence of these broad Big Data-driven mar-
ket intelligence initiatives will continue to increase,
as data become more useable and the benefits more
obvious.
Stakeholders
This approach in Healthcare through data creation
and engagement, sets-up new roles and responsi-
bilities, requiring careful management of the differ-
ent interests involved3. Some of the most relevant
stakeholders include: Providers of clinical/medical
data, Payers, Researchers, Developers, Marketers,
Government and Consumers. Patients are requested
to participate more intensively, namely by using de-
vices and digital applications. They are empowered
to gain more control of their own health parameters
and medication compliance. Moving from a patient
centric approach to a medicine oriented outcome,
processes of data integration and management are
needed to reach a more efficient outcome. Research
should be supported by credible tools, fully compli-
34 ant and operating under the adequate algorithms. To
predict opportunities, Pharma needs to collect data
that is relevant for the research purpose, conduct the
monitoring according with the best clinical practices,
ensuring drug safety reporting and systematically
evaluate patient’s outcomes. The implementation of
these processes will hopefully allow technicians to
make a more efficient use of the available information,
aiming to support self-care and healthcare provid-
ers. The data captured by medical devices should be
stored and integrated in healthcare systems, allow-
ing for a robust patient journey. Payers should make
appropriate use of this information to better allocate
resources and decide based on real life data. They can
also predict the occurrence of certain pathologies and
invest in awareness campaigns. Governments hope
to transform traditional medicine through a more
personalized patient’s approach. Understanding the
relevance of Big Data will help them to reinforce the
need of data capture and utilization, to prioritize sys-
tems integration and better allocate resources to ad-
dress human and financial challenges.
Prevention and Early Treatment
Earlier is better when it comes to detecting diseases
like: cardiovascular diseases, cancer or diabetes, be-
cause we have a better chance to fight back. Analyz-
ing real world data, while exploring the potential for
Rev Port Farmacoter | 2015;7:230-236
mainstream use of sophisticated sensoring devices,
such as: the nano particles detector, the portable in-
direct calorimeter (measures oxygen consumption
and determine resting metabolic rate) and the con-
tinuous glucose monitoring chips. These will help
Pharmaceutical companies to better and more quick-
ly identify medicines that will be offering patients
more personalized options. For example, people with
fibromyalgia which causes widespread pain, fatigue
and cognitive issues, can cycle from doctor to doctor
for up to five years before getting an accurate diag-
nosis. Using a large Electronic Medical Record da-
tabase of de-identified patient data, Pfizer scientists
created a model to help clinicians identify patients
which might be suffering from fibromyalgia earlier so
that, patients can get effective care.
The Long and Winding Road
We have come a long way, information is currently
more quickly available but frequently, not the one
we really need. As mentioned, there are already avail-
able and operating a lot of electronic health records
and registries, but most of them are not representa-
tive, compatible or sufficiently exhaustive. The Big
Data approach differs from traditional decision sup-
port tools, once suggestions are mostly drawn by
real-time patient data analysis. It may help to trans-
late personalized medicine into clinical practice.
Opportunities
- Big data greatly expand the capacity of generating
new knowledge;
- It also helps with knowledge dissemination;
- Contributes to bringing personalized medicine into
clinical practice;
- It may allow healthcare transformation by deliver-
ing information directly to patients;
- The era of value-based payments or reimbursements
may provide a positive stimulus;
Potential Obstacles
- Limited number of initiatives to champion its wide-
spread use within clinicians groups or hospitals;
- Most champions for Big Data use (healthcare re-
searchers, pharmaceutical companies, public health
and other governmental organizations) do not de-
liver directly individual patient care;
- There will be considerable privacy concerns which
perhaps require more attention than those related
with financial data;
- Overreliance on electronic systems.

In order to overcome these obstacles, one needs to:
- Understand the value of Big Data;
- Balance ownership and data sharing;
- Ensure compatibility, combine different data sets;
- Network;
- Grant proper coordination;
- Defend data privacy without being over-restrictive;
- Polling data for better health results.
Outcomes
- Prediction data: identification of potential health
problems; involvement of potential patients in health
programs; benchmarking with similar realities, e.g.
countries, cities, hospitals, patients, etc.;
- Better evaluation: identification of non-responders,
potential related interactions, associated diseases,
clinical data, clinical results, comparisons with
real-world data; identification of the best health pro-
grams and the best outcomes;
- Monitoring: impact of programs on patient behav-
iors and health conditions, including side effects and
potential interactions;
- Reporting – patient’s behaviors according with
compliance outcomes, products misuse, (sleep mode,
diet, healthy habits, etc.).
Big Data has the potential to transform medical prac-
tice, by using information generated on a daily basis,
to improve the quality and efficiency of care.
The Contribution of Medical Affairs
Data integration enables comprehensive searches for
subsets of data based on the linkages established,
while smart algorithms linking laboratory and clini-
cal data, for example, could raise red flags concern-
ing safety or efficacy15. Traditionally Research &
Development in Pharma has been a secret activ-
ity conducted within the walls of R&D. In recent
years, the external collaboration with universities,
other Pharma companies, consultants, health provid-
ers and payers, expanded. By breaking internal silos
and enhancing collaboration with external partners,
pharmaceutical companies can extend their knowl-
edge and data networks.
Safety is not only a concern but a competitive advan-
tage both when regulatory submissions take place
but also, once the drug is on the market. Signals could
be detected from a wide range of sources, namely, on
web sites, webinars, online physician communities
and consumer-generated media that can provide data
on the reach and reputation of different medicines.
OPINIÃO E DEBATE
Customer insights can be captured and used to shape
strategy throughout the medicine development pro-
cess adding to experimental results, to identify oppor-
tunities for improving patient’s response. Partnerships
with payers, providers and other institutions are criti-
cal to these efforts. Customer facing Medical Affairs
activities are critical to attain this objective. Much
of the Medical Affairs work has to do with assessing
data, both our own and data generated by third par-
ties. However as described, Big Data refers to the man-
agement of several sources, to reach a common goal:
“ask the right questions; provide the right answers”.
Medical Affairs can make important contributions to
the adherence and rational use of Big Data in an ef-
ficient and pragmatic way, namely by:
- Sensitizing to the adoption of digital healthcare
data management;
- Training on systems;
- Defend the harmonization and compatibility of
healthcare systems;
- Demonstrate the added value of Big Data in the de-
cision making process (e.g. mobility, mortality, drug
usage, compliance, safety, costs, etc…); 35
- Identify relevant sources of publicly available
healthcare data integrate information;
- Show RWD advantages over traditional studies and
clinical trials;
- Capture insights to explore specific heath oppor-
tunities;
- Contribute to build know-how partnerships;
- Define priority of actions;
- Mitigate potential safety and commercial risks;
- Support publication of results (paper, poster, web…)
and debate.
The Future of Big Data
Technology will help stakeholders to early diagnose,
to predict diseases, to act and allocate resources in
the critical areas in advance. The available data sets
will differentiate procedures and drug outcomes, al-
lowing authorities to invest better and prioritize on
the most important areas. The use of social media
tools and analytics allows decision makers to better
understand trends and potential problems. Patient
monitoring according with behaviors, demographic
factors, etc., will help decision makers to better un-
derstand the potential roadblocks and future expense
trends. Every strategy will be monitored in real time,
for example: clinical trial results, adverse events, lack
of effect or adherence to treatments. Data integration
Rev Port Farmacoter | 2015;7:230-236
 OPINIÃO E DEBATE

will allow moving from silos to a well-organized sys- 9. http://github.com/TranSMART.

tem, where all available data will contribute to a bet-
ter health management. The future health model will
be in essence a collaborative model, with full engage-
ment of all participants, centered in the “patient” and
in the “outcomes”. This new methodology will trans-
form the way health professionals work, as well as,
citizens contribute to their Healthcare management.
Therefore, health professionals need to gain skills and
digital competence to be able to collect, store, analyze
and advice based on real life data and patient outcomes.
Strategies behind-the-pill will increase dramatically
during the following years while the drug will be only
one small part of the whole treatment.
10. Brandweiner N. Wipro.com: Infografic: The volume, variety
and velocity of Big Data. July 27; 2012.
11. Infographic: The Four V´s of Big Data; The Big Data Hub.
Disponível em www.ibmbigdatahub.com.
12. Tien JM. Overview of Big Data, a US perspective. The Bridge
– Linking Engineering and Society. Winter 2014:44(4):13-17.
13. The Pfizer Brussels Office Bulletin; EFPIA Annual
Meetings 3-5 June – Big Data in focus; May 2015 (6).
14. Matthew H. Forbes. Feb 17 2015. Disponível em www.forbes.
com/sites/matthewherper/2015/02/17/how-pfizer-is-using-big-
data-to-power-patient-care.
15. Cattell J, Chilukuri S, Michael L. How big data can
revolutionize pharmaceutical. R&D. April 2013.

Concluding Remark
Big Data is more about the question than the technol-
ogy. It is a direct outcome of the digitalization across
the healthcare system, with very relevant impact in
prevention and disease management. If used in com-
pliance with privacy laws and these will not become
over-restrictive, it may be extremely valuable for the
health gains moving forward.
36
Acknowledgment
A word of appreciation to the University of Lisbon
for its kind invitation to present and discuss the topic
of Big Data with honorable guests from the Faculty,
Research and Development Industry, Governmental
Institutions, European Federation of Pharmaceutical
Industries and Associations and Healthcare Providers
representatives.

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