Pharmaceutical
E x e c u t i v e e B o o k W h a t Yo u N e e d To K n o w
Information Overload Pharma’s Big Data Problem
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Information  is the lifeblood of modern medicine. And like all things abundant, the central question is: What to do with it?
Pharmaceuticals companies believed for years that the pill was a stand-alone product rather than part of an integrated service offering. It followed that all the data compiled—from assay testing to the registration package to post-approval marketing and promotion—was seen as little more than a means to an end.
Information Overload / 2
The tipping point was that as the volume of data grew, it became intrusive. It attracted notice. At the same time, software technology was expanding in ways that opened new vistas of interpretation: all that data could be compiled, assessed, and applied to yield insights about everything surrounding the pill.
Opener / 3
It became possible to transform raw, disaggregated bits of information into organized, useful knowledge, with clear metrics to drive real differentiation against the competition. — William Looney, Editor-in-Chief, Pharmaceutical Executive
Opener / 4
Introduction In the last few years, the transformation in how big pharma uses information has become complete. What was formerly a functional sidebar – a storage headache – has become a strategic asset like intellectual property, a tangible source of value in its own right. Information not only tells big pharma where and how best to scale up its resources, it also repositions the industry for an educational role in persuading key stakeholders like the physician to change their behavior to lower the cost of treatment,
based on appropriate drug interventions. Neil de
consequences in remedying historically elusive
Crescenzo, SVP of Oracle, points to three
challenges like improving poor rates of patient
interrelated priorities that the pharma majors must
compliance. “The sky is the limit on the potential
focus on: build information “platforms” across all
from creative use of the technologies now coming
key operations, with the objective of finding
on stream,” he said.
synergies to drive speed and efficiency, thus lowering costs; exploiting new software applications to advance predictive analytics so that useful correlations in the expanding data stream can be uncovered to drive strategy and produce new insights about the customer
In the following pages, we cast additional light on the industry’s slow transition toward an information-driven business, where data is a scalable – and sellable – part of its value proposition to a more diverse range of customers.
mindset; and using data tools to foster more
We begin with Don Ragas of IMS who offers up
social collaborations around specific methods like
insights based on his own experience as a “data
gamification, which give companies a way to
pruner” in asserting control of the data explosion
shape consumer behavior – with positive
—the digital world is forecast to hold upwards of
intro / 6
2.7 zettabytes of data by 2013, an amount
and out-comes through the creative use of
equivalent to 700 billion DVDs—to help drive
information technology.
profitability through predictive analytics that help companies understand what customers actually do, not say. Following, we have a voice from the front line, Biogen Idec’s Chief Information Officer, Raymond Pawlicki, who notes his greatest challenge is building a team with the versatility to connect the dots between insider techno-speak and the strategist’s focus on the business – the big picture. Another feature addresses the specific challenges in leveraging information to improve the speed and accuracy of regulatory submissions in obtaining a marketing authorization. Finally, we highlight three recent examples of progress in advancing patient access
Throughout, our analysis—while acknowledging the speed and substance of new information applications—still puts the focus on the oldfashioned elements of function and process, where human will, skill, and ingenuity are essential to breathing practical life into the inanimate tool we call technology. Biogen Idec’s Pawlicki puts it best—what comes first is creating and certifying efficiencies in-house: if you outsource a mess, expect to get an outsourced mess in return. — William Looney, Editor-in-Chief, Pharmaceutical Executive
intro / 7
Big Data Big Challenges Big Rewards Opportunities in the Information Explosion By Don Ragas, Chief Architect, Global Operations, IMS
On both the clinical and commercial sides of the pharmaceutical business, the options for using data have proliferated to the point of becoming overwhelming. Everything is bigger, from the databases themselves, to the invest ment required, to the payoffs for getting it right.
Walls Are Tumbling Down Other sectors—namely the retail, consumer packaged goods, and financial industries—have been coping with Big Data for as long as a decade. So, why is it just now becoming a topic in the pharmaceutical industry? There are two interrelated reasons: First, the healthcare delivery system has traditionally been very fragmented, and information has not flowed freely across entities. Rather, each party has used its own data (or created data as a biproduct of automation), and there was no impetus to share it. However, with the rapid increase in usage of Electronic Medical Records (EMRs), which is the result of federal funding, the creation of Accountable
Care Organizations (ACOs), and the
The Obama administration further
rise of health information
reinforced the need for Big Data in
exchanges, those silos are breaking
its March 29 announcement of $200
down. There is a drive to allow
million in funding for a “Big Data
information systems to
Research and Development
communicate with one an other
Initiative,” which seeks to improve
across all points in the delivery of
our ability to extract knowledge and
care.
insights from large and complex
Second, there is a growing, almost insatiable, demand for information as healthcare becomes evidence based. Every party in the system from manufacturers, to payers, policymakers, to providers and patients has much to gain from
collections of digital data. While the initiative is intended to address scientific discovery, environmental and biomedical research, education, and national security, healthcare clearly stands to benefit from such significant investment.
understanding what works and what
The new sources of information that
doesn’t. And that requires a
are causing such a stir within the
comprehensive view that can only
pharmaceutical industry include:
be gained from multiple data sources that,when amassed, become Big Data.
Electronic Medical Records. The data contained in these systems provide a detailed clinical picture
Rewards / 9
within the site detailed clinical picture within the site of care and contribute to an overall view of a patient’s treatment pathway.
will work, person by person. Track-and-Trace Systems. If the FDA succeeds in mandating that pharmaceutical companies install
including secondary data, a company’s own closed-loop marketing program, or other internal data—the Big Data challenge grows exponentially.
Social Media. Patients use social
systems to track and trace their
networking to, as the Pew Internet &
products, the systems would
American Life Project described it,
generate a data point every time a
“lend a hand, lend an ear, lend
package “hits a node” on the
Underlying the interest in Big Data is
advice” to one another. “Listening in”
distribution system.
the desire to gain a competitive
on such public exchanges can
Big Value in Big Data
advantage via speed to insight and Real-World Evidence. Privately
faster, more effective decision-
funded and government-sponsored
making. Companies that lag
longitudinal studies produce a
behind their peers and other
Personalized Medicine. When, in
wealth of information on treatment
stakeholders in making use of
the foreseeable future, an
practices, patient persistence and
Big Data risk being at a
individual’s genome can be mapped
compliance, and health outcomes,
disadvantage at the research
affordably, the amount of data—
which are increasingly required by
bench, in the market, and at the
while staggering—will bring
payers.
negotiation table.
When all of these elements are
It becomes obvious even through
added to existing information
the following broad list of potential
sources—
applications that no company could
provide rich insights into the patient or prescriber perspective.
exponential value to medicine. It will be possible to go beyond understanding what works and what doesn’t, to actually predicting what
Rewards / 10
afford to be left behind in using Big
offer as a tempting array of choices.
they begin, organizations must
Data, which can be used to:
But on what should they spend their
consider collection, aggregation,
dime? What is the best investment
integration, and presentation of the
strategy? Which new sources will
data. What technology investment is
yield the greatest return? What
required to store and mine the data?
might they miss if they head down
What should be done in-house,
one path too early?
versus by business partners? What
Uncover unmet needs Assess the feasibility of clinical trial designs and recruit trial subjects Demonstrate product value Conduct pharmacovigilance React more quickly to market changes via real-time market measurement and sophisticated KPIs Enhance commercial activities and enable more personalized messaging
This speaks to the need to not only understand what can be gained from each new source of information, but to also work backwards from an understanding of what it is a company wants to achieve. Just as “form follows function” in design, “data follows
Deploy predictive capabilities rather than retrospective analytics
Ready or Not Here it Comes Like a kid in a candy store, the industry is looking at the new data sources and the insights they can
strategy” in business.
skills and IP should a company safeguard as a competitive advantage?
Are We There Yet? The necessary technology to deal with Big Data either exists today or is currently in development. And, since technology is always advancing and changing, it could be
Questions also inevitably arise
argued that a company’s plans
around a company’s ability—from a
should be “technology agnostic.”
technical, organizational, and intellectual standpoint—to extract the value from Big Data. But before
Consider the various layers of technology involved:
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Collection, Aggregation, and
is a methodology being tested by
scientist captured it well. While
Storage The technology exists to
Internet search companies that may
referring to his computer, he
collect, aggregate, and store
be applicable to industry databases.
lamented, “The cure for cancer is in
massive amounts of structured and
Essentially, it uses algorithms to
that box, but we can’t get it out.”
unstructured data. It requires a lot of
reduce the amount of data that
“heavy lifting,” but it can be—and is
needs to be restructured when it is
—done. IMS’s technology
loaded by spotting what has
infrastructure is a case in point: We
changed. Further into the future, we
routinely process 38 billion
may be able to do away with having
transactions each year, which are
to retrieve data from storage when
collected from nearly 700,000
we need it; everything could be
reporting sites worldwide. Few
immediately accessible in memory
pharmaceutical companies are likely
on solid-state disks.
able to process data on this scale cost-effectively on their own, simply because of the upfront investment required.
Analytics. The tools that can support analytics across Big Data are becoming available. Software manufacturers and service providers
Even so, we are seeing advances
are investing billions in their
today and on the five-year horizon
development, although we certainly
that will short-circuit some of the
are not there yet when it comes to
work and time required to code and
being able to analyze every aspect
extract data. In the near-term, there
of Big Data simultaneously. One
One exciting area of progress is in predictive analytics (as opposed to retrospective analytics). This will be invaluable in marketing (being able to predict customer behavior), outcomes research, and potentially for payment and reimbursement schemas based on historical behaviors. Reporting. Great strides are being made in data visualizations, and mobile business intelligence is quickly emerging as a capability. Data visualization tools can be utilized to enable non-data programmers to analyze the data in real-time. More comprehensive
Rewards / 12
mobile reporting is on the way, and
It likely will be impractical for
Setting the company’s
companies ought to be establishing
pharma to be in the business of
technology strategy and
their mobile strategy now.
acquiring Big Data, given the vast
designing the architecture for
number of sources and privacy rules
internal systems
So, the necessary technology is coming along, and, in fact, is already ahead of most firms’ ability to adopt it. The limiting issues and most daunting challenges around Big Data are related more to a scarcity of resources (talent, time, and budget) than they are to technological capabilities.
The Human Element
associated with this. At the same time, it my be highly inefficient for pharma to process and deliver the
Implementing and overseeing data governance
data, as cloud-based computing and
Managing the company’s many
storage has made owning storage
business partners
and processing impractical for most entities at the scale the cloud affords.
Designing or approving new analytical algorithms and approaches
The IT infrastructure for dealing with Big Data will be in private and public
In the continuum that stretches from
clouds and maintained by someone
acquiring Big Data on the one end
else. Routine analytics will be
to reporting findings from it on the
outsourced. Reporting will be
other, what should pharma keep
outsourced. What companies must
“close to the vest?” What functions/
have, though, will be people
responsibilities ought to remain in-
responsible for:
Understanding the insights that analytics provide and using them for applications that provide strategic competitive advantage Setting performance indicators
house?
Rewards / 13
The Way Forward A first step, firms must recognize
This team should be charged with
investment; the cost of Big Data will
developing an enterprise-wide
preclude functions from buying data
information strategy that covers:
without regard for how it might be
that partnerships with third-party providers will be required, given the
The types of data that are
considerable costs involved. Data
needed
aggregators, cloud solution providers, and analytical software companies all will play some role in the necessary capabilities. The fastchanging environment requires being open to new and evolving data and technology solutions. Second, companies would do well to create a Data Governance Council —a cross-functional team with representatives from IT, business strategy, HEOR, clinical development, market research, commercial analytics, legal, and compliance.
Where the data will come from What level of quality is needed (this will differ by application) How quality will be maintained
used elsewhere. Indeed, the lines between clinical and commercial applications of data are already becoming blurred. Each company will obviously have to find its own “path to enlightenment” with Big Data, but it will almost certainly involve a new
How the data will need to be structured
way of working. This will be apparent in what remains
Allowing separate research, brand,
proprietary IP versus what is
marketing, and managed markets
outsourced, as well as through a
groups to acquire data separately
new level of collaboration across the
will sub-optimize the company’s
enterprise on data purchases, data
path forward. Data acquisitions
management practices, and data
should be considered for their
uses.
potential appeal to multiple users and ensure that companies gain the maximum value from their Rewards / 14
Just as “form follows function” in design, “data follows strategy” in business. Barry Crowther, Senior Principal, IMS, on enabling your business process by integrating analytics across functions
Rewards / 15
Biogen Idec Sets A New Pace A Conversation with Raymond Pawlicki, Chief Information Officer By Marylyn Donahue,
Pharmaceutical Executive, Special Projects Editor
It has been nearly two years since George Scangos took over as Biogen Idec’s CEO, with a mandate to set a new course for a company that seemed to have lost its franchise title as “first to innovate” in the fight against serious diseases. Scangos lost no time in refocusing the pipeline, installing a few of his own people to strengthen the management team, and restoring enthusiasm in an organization that was, in his words, moving too slowly and too cautiously. companies find that edge against
What Biogen Idec and other pharma
information as a key source of
companies are discovering is that
competitive differentiation.
innovation is not just about commercializing new products. Processes—including the tools and technologies that help deliver knowledge to those who need it— are becoming just as important in helping companies find that edge against the competition. At Biogen Idec and other biopharmaceutical and pharmaceutical companies, leadership in innovation is coming from an unexpected internal source: the Chief Information Officer (CIO). Once a function that was highly
Leadership in innovation is coming from an unexpected internal source: the Chief Information Officer (CIO)
According to a recent report by McKinsey & Company, today’s CIO needs to operate in much closer alignment with business units by embracing new organizational models that call for joint decision making. The CIO must join with his business counterparts to seek out and implement technology-based innovations that will give companies long-term advantage in anticipating the needs of a fast-changing customer base. The CIO should also be able to transform cost structures, eliminate operational
specialized, technical, and routine,
silos, and build new operating
the CIO is now a driver of strategy,
models capable of maintaining
with responsibility to deliver success
efficiency in a fully globalized
around a platform that emphasizes
enterprise.
Biogen
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“We are constantly looking for ways to drive business by leveraging technology. We try to exude and leverage innovation in everything we do,” says Raymond Pawlicki, CIO of Biogen Idec, who also served as interim head of Human Resources as well as being a member of the Executive Committee. For a glimpse of the new CIO at work, Pharmaceutical Executive recently talked to Pawlicki about his evolving role at the company. Affable, plain-spoken, and generous with his time, Pawlicki defies the stereotype of the unapproachable, tech-speak expert.
RP: I have a very simple saying that
The folks on the IT side who have a real intellectual curiosity about wanting to find biomarkers.
when IT and the business have a genuine partnership, a lot of good things happen. When that spirit of partnership is not present, then you have the reverse: good things stop happening. One reflects the other. So a good partnership is crucial to success. The challenge is actually being able to create that partnership and maintain it over the ups and downs of the business cycle. PE: The position of CIO has changed radically from one of technical support to strategic leadership. This includes being able
PE: How has Biogen Idec’s cross-
to help build and maintain a long-
functional focus, streamlined
term competitive advantage for the
portfolio pipeline, and global reach
company. What does a CIO need to
shaped your own priorities as CIO?
pay attention to for this to happen?
Biogen
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RP: A few years ago at Biogen Idec
from this iterative process new ideas
we created a new role—Business
on how to leverage technology or
Information Manager (BIM). A BIM is
information to help drive the
essentially asked to be a mini-CIO for his or her own business function. For instance, there might be a BIM for sales, a BIM for marketing, and so forth. They have a direct line into me and a line into the head of their function. The head of the function can then engage with the BIM as a partner in how to leverage technology and information to help
If you outsource a mess, you get an outsourced mess
business can cohere and emerge.
Talent PE: It’s been said that biotech environments provide the right cultural atmosphere to attract maverick talents. Has that been your experience? Or has it been difficult to attract IT talent with a new, broader mindset?
drive the business unit’s goals and drive the business overall. The BIM
RP: People with technology
sits at the table with the head of a
expertise, who also speak the
function as a true partner—
language of business and possess
participating in strategic
the added value of a genuine
conversations and helping to
intellectual curiosity about how to
execute the annual operating plan.
improve the business, are not easy
The BIM becomes part of the fabric
to find. The qualifications are
of that function. We’ve found that
demanding. To give you an idea:
Biogen
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One of our BIMs has a CPA, a
people understand the importance
Master’s in finance, and a Master’s
of speaking in business terms and
in software engineering. He can go
to understand that the layperson is
deep on finance. He can go deep on IT. In addition, he has excellent communication and listening skills. If an IT person is sitting at the table and he or she is able to participate but has trouble listening and is stuck in a narrow technology mindset, then it doesn’t work. PE: How can you prevail in using technology as a linguistic tool to communicate effective messages of innovation and business transformation to everyone across the enterprise? RP: This is actually one of the biggest challenges on the infrastructure side of IT. You need to ensure that your infrastructure
When the spirit of partnership is not present, then you have the reverse: good things stop happening.
not going to get the acronym-laden techno speak. If you do have an IT person in infrastructure who loves speaking that way, it impacts the entire organization’s reputation. Others will say, “They’re a bunch of people who can’t communicate well.” And that is not the reputation that will help IT make a positive difference to the business. We want IT to be seen as a central business function that cares about driving the enterprise toward success. Having said that, we need to be extremely competent technically. Melding these two capabilities is one of the inherent challenges that all IT organizations have to deal with.
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PE: I’m getting a sense that at
people. I have a passion for this,
Biogen Idec in every major business
and all of my colleagues can sense
conversation there’s someone to
that passion. During an interview
ensure that IT is incorporated into the discussion, correct? RP: It varies. Often it is someone who says, “You know, technology isn’t going to make a big difference here. This is more about the process,” or, “We have to focus on the underlying behaviors.” The
We want IT to be seen as a central business function
you can tell right away if that particular individual may be a bit more technology-focused than business-focused. And we really need a genuine 50/50 split on it— that’s what I look for first in recruiting talent. PE: What, then, are your key
perspective we provide changes
influencers in building an
with each issue; that’s where the
organization?
cementing value of partnership shows up.
RP: I focus a lot on ensuring IT, as a function, is a singular team and
PE: Overall, how many BIMs are in
works as a well-oiled machine. And
the company?
so for all of my direct reports, I tell
RP: We have probably 15 to 20 BIMs in the organization. And one of my key roles is creating the BIM structure and finding the right
them they are equals in a senior IT leadership team with a responsibility to “stretch” to assess things beyond what is conventional practice or is in
Biogen
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their domain. The mindset is about
An example is when the iPad
working together, being open,
platform came out. If we had been
flexible, and really listening for what
overly focused on standards and on
is possible, even if it’s not in the rule-book.
Being Nimble PE: How does excellence in leveraging information and analytics to inform business decisions give a company a strategic market advantage? Is there an example you can provide?
I have a passion for this work and my colleagues can sense that passion.
testing it to the nth degree, we might have been too late in rolling out iPads to the sales force. But we struck a balance, saying, “Okay, this is an opportunity for us to be nimble and to act.” As a company, we’re not too big and we’re not too small. And that’s really how we gain our strategic market advantage; combining scale and resources with being able to act quickly, to deliver,
RP: The key to being able to foster
and not getting caught up in endless
excellence and to drive a strategic
self-examination and the
advantage is for IT to strike a
bureaucracy that breeds inertia.
balance between creating broad, scalable solutions for the whole
PE: If information is a strategic
company and being nimble so we
asset, how do you place a value on
can quickly react to the needs of a
it and prevent leakage that creates
specific request.
an advantage to competitors?
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RP: IT security or cybersecurity is
much time, money, or effort and
quite a hot topic these days, given
going too far to the extreme,
cloud computing, mobility, iPads,
preventing the nimbleness we talked
social media, and so on. The key is to have an agreement as to what level of security you want for your company. We don’t deal with the Department of Defense. But if we were in that business, we would want to ensure our level of security was a level five out of five. Given where we are in our industry, in our company, and depending upon subcategories, we want to be a three or a four—maybe an
The second you think you are secure, you’re probably not.
about earlier. Once you pick where you want to be, then you have to go at it really hard and almost be obsessively neurotic about getting there. The hard part is, at the second you think you’re secure, you’re probably not, given the dynamic environment and the amount of change that’s going on.
Biomarkers
occasional five. It is an important component to be able to come out
PE: In what areas will technology
of the gate knowing what, when,
provide the most strategic value to
and where you need to establish
Biogen Idec, and why?
that level of protection. It’s best to start with the end in mind. That way, you do not end up spending too
RP: We have the potential to launch multiple new therapies in the coming years. Hence, we’re going to need
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/ xxiii
to scale up our information and data
The industry is moving towards
analytics processes and systems to
more of a personalized medicine
ensure timely rollouts. Otherwise,
environment. That’s a really exciting
we’d have to hire many more people. These automated processes and singular systems of record must be in place. We’ve already done a lot of that but have more work ahead of us. And being anticipatory has been a real advantage to us from a cost-controlling perspective. We’re focusing on trying to do more sophisticated analytics and integrating information around imaging, clinical data, and samples —to really start to see if we can identify biomarkers and to be able to say what drugs might be the most
We’re focusing on trying to do more sophisticated analytics.
component for IT—and specifically for analytics—to help try to tease that out and see if we can identify specific biomarkers. To a large degree, that’s a big area of focus for IT, and where it can make a very direct impact to the business. And again, it’s not just an IT initiative. It is a classic example of where a true partnership needs to exist between the component of the business that’s responsible for finding biomarkers and technologists who provide the technologies that deliver and integrate the results.
effective with what subpopulations.
Here at Biogen Idec, the folks on the
Information expertise is fundamental
IT side who have that technology
to this.
expertise have a real intellectual curiosity about wanting to find
Biogen
/ xxiv
biomarkers. That is the advantage
outsourced mess. But if we’re
of having the right person: the
creating a model that’s going to help
person with the passion as well as
us find biomarkers, or we’re going to
the right technical competence to be able to work with colleagues from other fields and create a genuine partnership. It’s an organizational dynamic that yields individual creativity and the excitement of aiming for something higher than yourself. PE: It sounds as if there’s a real desire at Biogen Idec to keep things in-house and not to outsource these functions—that it’s the wellspring of all this enthusiasm. RP: My personal opinion is that you
Analytics has gone from being in the background to the foreground, largely due to the cost of computing.
create a model that’s going to help the commercial team move in a different direction, you typically keep that in-house. And what you really want to keep in-house is the partnership spirit of those BIMs. Everything stems from that. PE: How has the strategic role of analytics changed at Biogen? And in what ways are you involved in creating evidence that drives decisions in reimbursement, for instance? RP: Analytics has gone from being
have to create the efficiencies in-
somewhere in the background to the
house first and make sure the
foreground, largely due to the cost
process is working well. If you
of computing. The cost of storage
outsource a mess, you get an
has come way down; and you can
Biogen
/ xxv
do things now that you couldn’t
have more visibility into where the
dream of doing just three, four, five
product is flowing; enabling some of
years ago. And most folks in the
the scientists to drill down on the
business realize that the capability to provide useful information to answer the questions of our customers—to establish value—is out there. So it’s taking much more of a front seat in what we do in the relationship with our customers. But you have to be careful with analytics; there must be a very focused approach to utilizing it. There are few broad-brush ways to leverage analytics. You need to understand how analyzing the information can make a difference to the business and be very focused in how to do that. For instance,
Moving towards more of a personalized medicine environment is a really exciting component for IT.
potential of an imaging tool to pinpoint clinical results; and to help our finance team do a better job at forecasting and modeling sales trends. These are specific initiatives. If you are not solving a real business problem, then you end up spending a lot of money without many results. But if the focus is on solving a business issue, the tools to do that are more capable than ever, and getting better every day. PE: What are the key gaps in your function, if any?
enabling the sales force to have
RP: The key gap is finding more
more information at their fingertips;
people to bring into the organization
enabling the supply chain folks to
who have an understanding of
Biogen
/ xxvi
emerging technologies and how to
right people, create the right culture,
appropriately leverage them. Right
ensure we have the right
now, we have a lot of people who
partnerships, and drive execution.
are very focused on the day-to-day work at hand. Sometimes it’s nice to bring somebody in who has a fresh perspective on using different technologies and to look at things differently. Diversity of thought and diversity of approach is what we want to continually weave into this organization. If we see a subset of the organization where everybody is thinking the same way and coming up with the same answer, that’s probably not a good thing for Biogen Idec as a whole. Refreshing the creativity quotient is thus another one of my key roles as CIO—besides trying to bring in the
Diversity of thought and diversity of approach is what we want to continually weave into this organization.
PE: What is the best way for IT to support ambitious business plans in emerging markets? And is it different from doing so at HQ? RP: When you branch out to new markets, you want to institutionalize and complement the systems and processes for the back office. You don’t want every new country or new region to be developing its own way to process an invoice, and so on. You want to leverage the global capabilities we already have in place. However, on the front side of the business, on the commercial side, you need to allow more flexibility. Obviously, there are language
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/ xxvii
implications and different ways of
possibility, where critical thought
practicing medicine and doing
and critical comments are embraced
business; that’s where we need to
constructively. In short, it’s to create
be the most flexible. So, we’re trying to leverage the back-end or commodity-like systems while providing more flexibility on the front end. PE: To help drive the business and to be a transformational and strategic function for the company, what are the top three priorities within IT for 2012? RP: One is having a culture where it’s okay to fail, where new ideas are heard, and where its okay to disagree. In turn, it’s not acceptable to be overly hierarchical, or to shut people down. The goal is to create a
We’re going to need to scale up our data analytics processes and systems to ensure timely rollouts.
a collaborative, results-oriented, technically competent set of leaders who really work together as a singular team. In 2012, driving that “culture of excellence” will be a big area of focus for us. Next, we intend to make our systems simple to use and easier to access. If we can make 5,000 people 10 percent more productive, that’s a huge impact to the company. So again, it is about moving away from too many small systems and building a singular system of record where things are done more efficiently.
space where new ideas can emerge, where people are open to
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The third priority is creating the infrastructure and systems to enable the filing of the drugs that we hope to launch over the next three years. We want to make sure that we’re very solid in having systems infrastructure and databases that are sustainable and scalable.
If you are not solving a real business problem, then you end up spending a lot of money without many results.
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Pharma’s Winning Innovative Technology Companies awarded for exemplifying a high level of operational excellence with technology. By Marylyn Donahue,
Pharmaceutical Executive, Special Projects
Bayer Healthcare Pharmaceutical for
Editor
demonstrating excellence and achievement
The ABBI (A Better Business Intelligence)
not only in information technology that
might not elicit the oohs and ahhs heard at the
creates value, but also for exemplifying a high
unveiling of the futuristic 3D smart TV at this
level of operational excellence.
year’s Consumer Electronic Show in Las Vegas, or at the introduction of the new iPad 3. But ABBI, is a winner in its own right.
“In the simplest terms, it is an enterprise data warehouse and analytics delivery system covering all aspects of commercial operations
An enterprise data warehouse and analytics
for Bayer Healthcare Pharmaceuticals
delivery system (incorporating social media
Corporation,” explains Rebecca Cotton, the
and collaborative technologies) ABBI is also
company’s Deputy Director, Operational
innovative, and very smart. Last year it won a
Analytics .
coveted CIO 100 award for
Information Overload / 30
Bayer was of only one of three
•
A Weaving of social media and collaboration technologies into the core of the service delivery, support and documentation activities of the group.
•
Application of the most leading edge, cloud-based, outsourced business model for deploying and delivering service.
pharmaceutical companies along with Teva Pharmaceutical and Pfizer awarded the coveted CIO 100 Award for showing ingenuity as well as pragmatism. The prize goes out annually to 100 combines across industries that “take risks with new technologies as well as those that create change through sheer will and straightforward smarts,” The competition is sponsored by CXO media, a business unit of the International Data Group.
Knowing where everything is ePedigree Serialization lacks that sexy techie ring, but like the ABBA it is both innovative, intelligent and another CIO winner. The award went to Teva Pharmaceuticals (an Israeli
Bayer’s Cotton described ABBI as bringing
generic drug maker), And at the very least the
three important technology-enabled
function of the ePedigree Serialization is easy
innovations to the company:
to understand. Imagine every unit (for
•
A holistic technology deployment that gently, but firmly, ushers our business user community into the world of a selfempowered knowledge workers.
example, a bottle), case, and pallet being assigned a unique serial number that is logged into a central database and tracked
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/ 31
from manufacture, through distribution, to
Used by other companies (IBM, Oracle) to
purchase by customers. The ePedigree
track counterfeit drugs, the ePedigree system
Serialization is a RFID-based system designed
required Teva to design, develop and
to track its products throughout the supply
implement a technology strategy and
chain to end consumers, enabling full chain of
business processes and systems that would
custody from point of manufacture through
be able to handle large volumes of data from
consumer sale.
nine different systems in an online
Teva’s, CIO Jimmy Wang told Information
environment.
Week that it had been a top initiative for the
The tracking system now allows Teva to
company along with “ the automation of our
efficiently comply with FDA requirements that
lab and manufacturing processes through the
ask pharmaceutical companies to provide a
implementation of electronic lab notebooks
validated chain of custody for drug products.
and manufacturing execution systems.
The benefits of ePedigree also includes the
“This will allow automation of the weighing
ability to protect consumers by preventing
and dispensing of raw materials into the drug
counterfeit products or products that have
production process,” explains Wang.
been tampered with from entering the market,
"
"
says Wang.
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Additionally, ePedigree lets Teva know exactly
industries. It is not even that new for Pfizer.
where products are purchased, helping to
But Pfizer is the first pharma company to
improve visibility for better forecasting and
introduce it globally for loyalty programs and
product recalls.
patient services.
And how does Wang over all measure IT
Designed by Pfizer and tested in the
effectiveness? “We use the typical IT
Philippines in 2009, the eCard now is
measures of scope, budget, ROI, schedule,
available in 15 other markets, including China.
etc.--but ultimately it's our ability to add real
And in 2010, it launched the program in
value and meet the needs of our business that
Russia.
determines if we're effective.”
eCard travels abroad
Pfizer partners with government agencies to distribute the cards to patients through healthcare providers. Patients present the
Pfizer’s eCard, the third CIO 100 winner to a
magnetic stripe cards to pharmacists to
pharmaceutical company, gives patients
receive discounts and provide usage data to
discounts on medications and information
doctors and to Pfizer. The flexible, centrally
about treatments and care in exchange for
managed and modular technology platform
data about customers and their habits. The
that supports Pfizer’s eCard program features
concept is hardly new for retail and other
a business-intelligence platform, a business
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/ 33
rules engine, and support for Internet, SMS
chronic conditions, allowing it to contact
and voice channels. With its flexible front end,
patients to remind them to take their drugs –
Pfizer’s eCard platform can be tailored to suit
and further boosting sales.
countries¿ varying eCard requirements, and can support point-of-sale systems from a variety of third-party vendors. The system’s business rules engine also allows for consistent data collection and analysis within a niche market or across a global business unit.
Some, potential problems are foreseen, however. Pricing discounts could trigger concerns that they influence doctors’ prescriptions, switching away from the most medically appropriate drug to a decision based on affordability. And Andrew Jack in the Financial Times pointed out that it breaks the
By allowing it to offer discounts of up to 50
traditional arms’ length relationship with
per cent to patients on the pharmacy price,
pharmaceutical companies, designed to limit
the move may help boost access to expensive
access to confidential personal data and
drugs by making them more affordable, while
prevent direct marketing without an
increasing Pfizer’s sales.
intermediary role.
It will also allow the company to monitor when
What’s Ahead: Trends
patients are not returning for regular repeat prescriptions for their medicines for long-term
A new report by Forrester Research “The Top Ten Technology Trends Enterprise Architects
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/ 34
Should Watch: 2012 to 2014” gives a glimpse of the business process and intelligence
tools as well as cloud application platforms and mobile that are slated to create significantly more business value between now and 2014 (see the following chart). “In a tight economy, BI allows CIOs to justify business decisions using hard numbers rather than gut feelings,” says Brian Hopkins, Principal Analyst at Forrester Research.
App Internet The report predicts that mobile apps and cloud services will merge to form what Forrester calls the “App Internet,” where specialized apps will use the storage and processing power of PCs, smartphones, and tablets and the scale and flexibility of the cloud to allow applications to communicate with other apps and devices.
The App Internet, if it plays out, would mark the end of the website as it is now known. It’s also certain to change how enterprises create apps and manage the devices that run them. Hopkins observes that employees often use more sophisticated mobile devices than their companies run. “This type of interaction requires a new architecture, and it’s not one that most companies currently support,” he says. He also adds this tantalizing bit of information. “An iPad 2 would have been one of the most powerful supercomputers in the world in 1985. Today, we take them everywhere—all that processing power is literally in the palm of our own hand.” Hopkins points out that as employees push the limits in their own adoption
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/ 35
Tech Trends: Today to 2014
Information Overload / 36
Information as a Competitive Asset Companies know they need to do a better job in managing information, particularly in sensitive areas like drug regulatory submissions. What they can’t see is where to start and how to leverage the right technology – where the possibilities are endless – to weave this vital capability seamlessly, across business units and ultimately throughout the enterprise. By Adam Sherlock.
Data is information waiting to
data is critical to producing the
practice protocols. In most
be useful. Today’s global
timely and accurate
cases, data gathering is
pharmaceutical companies
submissions required to obtain
managed locally, with regulatory
are riddled with data—so
basic marketing approval. .
departments compiling the
much that key business functions and the sophisticated information management systems that
Commonly, a regulatory submission begins long before the documents themselves are
specific information needed to adhere to legal requirements or to track commitments.
created. The process
What is often missing is the
commences with the generation
ability to aggregate information
of concepts that get
across the enterprise so that it
encapsulated into documents,
can be used to conduct more
which ultimately form the
predictive work, such as project
regulatory submission.
planning across the portfolio,
Submissions become part of a
resource planning, and pre- and
A relevant example – with
data portfolio developed and
post- marketing activities.
implications not only for the
executed across multiple
commercial enterprise but for
nations, with material that must
public health and safety – is
be carefully evaluated according
regulatory affairs, where useful
to rigorous and standardized
bind the organization together simply don’t know what to do with it all. Worse still, the data retrieved is usually disconnected, duplicative and, all too often, inaccurate."
In so doing, companies gain an advantage by managing their activities more holistically.
assest / 38
Despite this awareness, other industries have been quicker to
Cost of Failure
Poor information management can create operations
information management. !
Pharmaceutical companies are usually aware of the data they generate and have been adept at capturing it.
Perhaps one of the best
According to a survey by the UK
storage, for example; failing to
examples is the automobile
consulting group Ovum the
manage data results in the
industry; when safety problems
industry is ahead of other
retention of redundant and
arise with a particular model,
sectors when it comes to
outdated information and
the manufacturer can respond
adopting solutions-oriented
records, which requires more
quickly by leveraging its data
applications, such as customer
space that could be devoted to
base on warranties.
relationship management
other uses. There is also the
When a manufacturer spots a
(CRM) and enterprise resource
time waste associated with
trend, such as a faulty part, it
planning (ERP), but lags behind
chasing information needed to
can both ensure that its dealers
in business intelligence
meet regulatory requirements or
are ready with the new parts
approaches such as regulatory
to make a business decision.
and send out relevant recall
tracking and management
One particular problem that
letters, thereby helping to
systems able to harness data
company managers have
minimize potential liabilities.
productively.
identified in discussions with
grasp the importance of proactive, forward-looking
bottlenecks on multiple levels, as well as add unnecessary cost burdens. Take the cost of
assest / 39
Pharmaceutical Executive is
business decisions based on
the use of multiple terms or
informative data.
definitions to describe one thing, which leads to information about a product being retained in several systems, with each system classifying it under its distinct definition.
From a strategic point of view, good information management is what stands between a sluggish response to market demands and staying one step ahead of the competition. To
Given that the problem is
achieve the latter, all of a
compounded over time,
company’s information should
consolidating this information
be connected. In regulatory
can pose its own challenges.
affairs, submissions flow into
Everyone agrees with the basic objective of information management: to reduce the time it takes for people to locate
licensure, which then drives the direction of the portfolio. Tracking resources via project planning, the authoring process,
What is often missing is the ability to aggregate information across the enterprise so that it can be used for more predictive work.
relevant content and enable them to make confident
assest / 40
the submission process, the
entering the market and the
detailed and analytic
application process and,
state of current R&D projects.
understanding of all the
ultimately, approval makes it possible to form a bigger picture of how resources are being managed and where they might
This information can help answer questions such as: •
efficiently be directed. In turn, when an information system is property constituted, companies can use this
•
informational picture to predict the efficient deployment of resources across multiple products and countries. For example, good information management can concurrently track license renewals, products
•
components pertinent to a particular product.. If a problem arises somewhere along the
Is it in the company’s
line, it also enables the
interest to continue
company to quickly determine
marketing a particular
what the problem is and then
product?
devise a resolution.
Should the company
This is a critical capability now
consider a partner?
that the ease of access to this
Are there opportunities for a product extension and what would the market potential be for any additional indications?
that are coming to the end of
Good regulatory information
their patent life, new products
management results in a
information can also be interpreted and applied by outsiders against the commercial interests of the information holder
assest / 41
From bottom to top Successful information management requires a flexible set of technologies that encompasses all enterprise
archiving, and external sources
task of finding it. Furthermore,
of data, which may encompass
there’s a need to standardize
cloud deployments such as
the way information is classified,
software services, RSS feeds
as the use of different terms
and web generated information.
negates the basic value of data storage: if you can’t access it
applications, including
Next comes data management,
document management, ERP
life cycle management, the
and customer management.
retirement of old data that is no
Ovum analyst Sarah Burnett
longer required, archiving and
describes the complete,
records management. Often,
multi‑layered enterprise
companies have data or reports
package as the “information
that, while not active, need to be
What that means is that more
management stack.”
accessible in the near term.
time needs to be spent
The information stack begins at
Even though some solutions
the infrastructure level, which
allow for this type of storage, it’s
comprises both internal
also important that companies
applications, such as file
learn how to classify information
systems, databases, and
to simplify the often arduous
readily, what is the poing of compiling it in the first place? Another crucial aspect of data management is metadata management.
resolving issues around data definitions and improving data quality because having good and consistent data from the outset will allow companies to produce better quality reports
assest / 42
and analysis. The third layer in the information management technology stack comprises data extraction and integration. First, there’s data warehousing or data consolidation, which deals with longer-term data cycles. This system is most appropriate when there are definitional discrepancies or when a lot of data cleansing is required. Data warehousing or
during drug development,
data virtualization enables users
business leaders can use the
to quickly access data that is
data to analyze the value and
pertinent to their particular
cost of the project.
requirements. Master data
Another technology that fits into the extraction and integration layer is data federation, or data virtualization, whereby a department or business leader might grab snippets of information from different systems for quick access and analysis.
data consolidation is valuable in
This technology is most
so far as it lets personnel
applicable for small quantities of
conduct multidimensional
data that don’t require
analyses. If, for example, a
substantial transformation or
number of issues have arisen
cleansing. According to Burnett,
management, which gives users a single view of an important part of the business, such as a product or a customer, also fits into this layer. One example might be filling in missing pieces of data in a record or removing errors from a record. The final part of the extraction/ integration stack is serviceoriented architecture or data services. This is another way of breaking data into components that can be reused at various points throughout the
assest / 43
organization. The overriding element that drives all success is how well and at what cost information is delivered to meet the needs of the user. Information strategy has to focus on making information easier for the user to digest, understand – and interpret in a way that leads to a product or enterprise solution.
regulatory information management help companies to consolidate their disparate systems and produce analsyis grounded in fact that leads to better decision-making simply because it is relevant to the question at hand. Only by having clean, consistent and reliable data is it possible to build a broad picture of how an organization’s resources are
Delivery allows information to
being used and how they can
be synthesized: Regulatory
be maximized in the future
information management, for example, involves far more than just tracking submissions. The
The overriding element that drives all success is how well and at what cost information is delivered to meet the needs of the user.
processes and technologies used to enable successful
assest / 44