Whitepaper developed with Pharma Exec magazine on how EIM- Enterprise Information Management- can provide efficiency and kick start innovation by ensuring information flows correctly inside- and outside- the company

1. SPONSORED BY
Bringing Intelligence to Drug
Discovery—The Importance of
Contextual Information at All Levels
An Executive
Summary
Bringing contextual information to multi-step, multi-
department activities involved in commercialization
of new therapeutic agents or devices.
Overview
The biopharmaceutical industry is on the cusp of deploying new comprehensive information
services technologies that can inform key clinical and commercial decisions in ways traditional
information systems cannot. Information management is becoming an essential part of the
intelligent discovery and management processes that span departmental siloes to improve
decision making and reduce costs across the organization. Nearly one-third of delays in deci-
sion making can be traced back to a lack of data integration across departments. Forty percent
of operational costs are lost in information sharing across departments. And, lack of historical
context doubles the cost of early drug discovery.
This article explores the potential for bringing contextual information to the multi-step, multi-
department activities involved in bringing every new therapeutic agent or device to market.
The tools to provide insight across multiple information sources already exist, but few firms
have developed the expertise to apply those tools to bend innovation curves up and cost
curves down.
Achieving True Enterprise-
Wide Intelligence
The biopharmaceutical world is moving toward
an all-digital information world. Impelled by
regulatory, commercial, discovery and devel-
opment demands, most firms have embraced
the need to move away from physical data
repositories to digital information resources
that are available across the organization.
The goal is not just to improve operational
efficiencies, but also to improve insight across
all information sources, departments and
operations to bring intelligence to the entire
organization. The key value is not the depth or
the breadth of information that is available, but
having the right information available to the
right people at the right time to make better
informed, more insightful decisions.
Decision making is a perennial bottle-
neck in any large organization. Biopharma
executives estimate that 30% of the delay
in decision making is due to the simple lack
of data integration (see Figure 1). The right
people do not have the right information at
the right time.
Organizations try to improve decision making
by sharing information across departments.
But without an overarching vision of what
kind of data are available, data sharing is ad
hoc, unpredictable and unsecured. Fully 40%
of operational costs are lost due to a lack of
simple cross-departmental information sharing.
Christopher Wynder, PhD
Content Services Product
Marketing Manager
OpenText

2. THE IMPORTANCE OF CONTEXTUAL INFORMATION AT ALL LEVELS
Lack of historical context
is another familiar barrier. Not
having historical context impels
researchers to repeat work that
may have been done before,
either in academic settings or
elsewhere within the organiza-
tion. Duplicating prior work and
not recognizing earlier failures or
successes doubles the cost of
early drug discovery.
The need to integrate data
across departments and make
information more widely avail-
able is widely recognized. In fact,
it is so widely recognized that no
single department or executive
owns the problem. The path
forward is clearly analyzing across workgroups to chart the
right course. But each workgroup is running harder and harder
trying to keep up with continual updating of labeling and off-
label use descriptions, security and governance of at-home
medical devices, the growing use of artificial intelligence
and robotics, consumer device data, ensuring compliant
marketing, discovery and research, sourcing APIs and novel
bioactives and other tasks. Digital disruption is projected to
accelerate to the point that technology will change more in the
next 15 years than in all of human history. Technology created
the problem, but technology can help resolve it.
An information management platform is the most effec-
tive way to get ahead of change and reset the course of
the organization by improving information access. The right
platform address four key challenges: discovering information,
managing information, market research and keeping data
connected as key personnel or leave, file types and formats
change and organizational goals and priorities evolve. It all
comes down to balancing access and security of information
and ensuring that every department is speaking the same
language (see Figure 2).
Departments and medical specialties are all tribes.
Cardiology and nephrology each have their own jargon, as
do regulatory and marketing. In order to share information in
useful ways, each group must be able to speak with and work
with other tribes within the organization. They need an internal
Rosetta Stone to foster communication, understanding and
decision making across the siloes.
OpenText Confidential. ©2018 All Rights Reserved. 4
Intelligence requires insight across information sources
30% of delays in decision making is due
to lack of data integration
40% of operational costs are lost in
simple cross departmental information
sharing
Lack of historical context doubles the
cost of early drug discovery
Sources: KPMG, Accenture, Forbes, Lancet, NEJM, internal
RD
Figure 2: Innovation in drug discovery requires diverse information sources.
Figure 1: Intelligence requires insight across information sources.
Sources: KPMG, Accenture, Forbes, Lancet, NEJM, internal.
OpenText Confidential. ©2018 All Rights Reserved. 7
Old files
Innovation in drug discovery requires diverse
information sources
Post-release
Discovery
es
iscovery
Incompatible
sources
Lost knowledge
Data
connections
Market research

3. BRINGING INTELLIGENCE TO DRUG DISCOVERY
Different Sources, Same Language
The original Rosetta Stone was a translation key, inscribed
on stone, that linked Egyptian hieroglyphics with Greek and
enabled modern scholars to read ancient Egyptian writings.
Biopharma organizations face similar translation challenges.
They must reconcile information from published sources such
as PubMed or scientific journals with information gleaned from
disease-specific patient interest groups, social media, images,
audio and more. Information may appear as scrupulously
formatted documents, visual or audio files, handwritten notes,
transcripts, articles, informal notes, postmarketing data and
more. The organization must identify which information sources
are appropriate to include in decision making for different levels,
times and purposes (see Figure 3).
The first step is to separate the information from the format in
which it appears. All documents and other information sources
that come into the organization electronically, in hard copy or in
some other format can be sorted and stored automatically in a
centralized information repository. From there, it is a matter of
applying access tools that allow anyone within the organization
to access the central repository in ways that promote informa-
tion access while ensuring information security. For example,
any item that mentions cardiology but does not include
identifying data such as billing or patient identification could be
available to everyone in the cardiology unit from management
through basic research while items that include patient ID might
be restricted to specific clinical trial personnel.
Broadening access to information can transform the organi-
zation by encouraging innovative thinking. The drug discovery
pathway extends from new molecule to drug candidate to
testing, approval, marketing and use. Biopharma traditionally
builds information roadblocks between each stage to enhance
information security. What those roadblocks really ensure is
information gaps. Attempting to bridge those gaps produces
45% of all information breaches, according to data security
surveys by Ponemon, Verizon and Calypitix.
The most common scenario is someone trying to get the job
done as expeditiously as possible. Passing key information to
an internal colleague via an external means such as files on
a flash drive may be efficient, but it is also a data breach. So
too is deleting data an employee believes may have negative
implications for the company. This has lead to the industry to
lock down information in an attempt to limit data breaches.
There are some examples that this may in fact be harming
innovation and bring a different type of risk to companies that
do not have the ability to control information access intelli-
gently. For example, communication and access to information
is a key reason why Pfizer had a failed cardiac drug, silde-
nafil, that a few investigators noted had unusual sexual side
effects. Those side effects were discussed informally inside
and outside the company, which could potentially be a data
breach, without the NDA agreements that clinical trial doctors
typically sign to allow them to communicate with the company.
The chatter eventually reached the development team, which
realized this one failed agent might point the way to an entirely
new class of drugs and Viagra was born. In today’s digital
environment, it is paramount that organizations increase their
chance of this type of innovation through better information
security and access controls.
“Information management can turn
potential savings into real dollars by
using artificial intelligence to proactively
present information to different users
based on their needs.
”
Figure 3: Detach information from format to ensure findability.
OpenText Confidential. ©2018 All Rights Reserved. 9
Standardize,classifyandroute
Extractinformation,organize
sourcefilesconnecttoexisting
Detach information from format to ensure findability
AUTOMATED
SORTING
FULL-PAGE
IMAGE
TEXT-BASED
ANALYSIS
PRECISION
ANCHORS
HAND-
WRITING
Content
analysis
Text-based
analysis
Source
classification
Handwriting
Data extract
Full text
Index
Competitive
Operations
Trials
Public relations
User-based
search
Workgroup-
based
predictive
content
surfacing
Find

4. THE IMPORTANCE OF CONTEXTUAL INFORMATION AT ALL LEVELS
While data breaches are a big deal, organizations have as
a rule unnecessarily secured access to legitimate additional
information sources that may provide key information and
cost savings. PubMed searches and other sources suggest
that about 75% of the preclinical work done in biopharma to
establish a therapeutic index (i.e., the range between a thera-
peutic dose and a fatal dose) for potential drug candidates
is duplicated in academic and other settings. Because most
biopharma firms lack an information management platform,
they have no way to incorporate, verify and apply that kind
of outside information. It costs about $600,000 to build each
preclinical therapeutic index. The typical pharma is working
on 15 candidates at any one time, a cost of about $9 million.
Being able to incorporate outside research could save 75%
of the effort, $7 million annually and hundreds of millions of
dollars longer term by eliminating more candidates with narrow
therapeutic indexes earlier in development.
Information management can turn potential savings into
real dollars by using artificial intelligence to proactively present
information to different users based on their needs. About
80% of what any given user sees falls within the everyday
scope of their job. The real payoff is in the other 20% that may
be only tangentially relevant or possibly just interesting—like a
failed cardiac drug that sometimes produced erections.
Dusty Archives, Old Files
Pfizer was lucky that sildenafil didn’t drift into the archive of
failed and forgotten candidates that every developer accumu-
lates. In an era when discovery costs are hitting $200 million
and a launched drug costs another $500 million or more, the
opportunity to find a new case for even a single failed agent
is immense.
Alzheimer’s disease, among others, is being associated
with a growing number of drugs that were not originally con-
sidered for the disease. Organizations that have intellectual
property rights and easy access to lab notebooks, trial results
and other data for older agents are ahead in the discovery
game. There may be ways to retarget genes associated with
specific diseases to different classes of drugs or vice versa.
New, seemingly unrelated research may suggest new targets.
These are all very real possibilities, but cannot happen in any
organized and repeatable fashion unless researchers have
unhampered access to archival material to help them better
understand past success and failures.
Most organizations scan or digitize, then archive informa-
tion, which is promptly forgotten. What is needed are ways
for today’s researchers to search and explore yesterday’s
information in ways that are relevant to current projects. In
addition to fully indexing and connecting old data, that means
extracting data from formats that may not be compatible with
current technologies. Most organizations have caches of
archaic tape and floppy drives that may contain valuable data
but cannot be read without access to equally archaic drives
that may not be easily interfaced with current technology. A
concerted effort to locate old files and extract the data can
pay dividends far into the future (Figure 4).
As the transition from paper to digital gathers momentum,
information management is giving way to content manage-
ment. The promise is contextual information, bringing the right
information to the right person at the right time across every
step and every department that is part of the development
process from initial discovery to postmarketing surveillance.
Every organization has a treasure trove of information in files,
contracts, social media, online news, endpoint data, images,
published and unpublished research and lab notebooks
more. The tools already exist to provide new insight and new
intelligence across these multiple information sources. As the
pace of technological innovation builds, the organizations that
develop or hire the expertise needed to apply these new tools
will be in the best positions to bend their innovation curves up
and their cost curves down.
Figure 4: Protect your drug discovery pipeline through understanding past success and failures.
OpenText Confidential. ©2018 All Rights Reserved. 15

5. Protect your drug discovery pipeline through
understanding past success and failures
Capture
Digitize where
needed
Validate
edge cases
VisualizeProcess,
Classify, Extract
Manage
Central
Information
Repository