Research REPORT

DATA:
The land of
lost opportunity
Survey reveals that despite a growing
awareness of data’s value, much of pharma
has not capitalized on the potential offered
by new data management technologies

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 Pharma Manufac tu rin g: Resea rc h REPORT

p Safely and efficiently manufac-
turing drugs is predicated on not
only collecting, but leveraging the
right data.
Process data, which can be
defined as time series data gener-
ated by process control systems,
laboratory systems, and other
plant floor equipment, has
increased dramatically in phar-
ma’s new digital age. But without
the right data management sys-
tems in place, data is nothing more
than spreadsheets of wasted oppor-
tunity for improvement.
Are pharma manufacturers ade-
quately equipped to not only meet
industry data demands but to use
this data to improve operations?
The technology exists — including
predictive analytics, robotic process
automation, and AI-based tools, all
digitally connected via the Inter-
net of Things (IoT) — but many
pharma companies are struggling
to fully leverage all this data.
To better understand the
pain points surrounding data
management and software
systems, Pharma Manufacturing,
in collaboration with BIOVIA,
recently conducted a survey of
and use data to its full potential. CURRENT LANDSCAPE
Results revealed a need for a The pharma industry has always
validation-ready, integrated been data rich. Drugmakers col-
system for data aggregation, lect massive amounts of data at all
contextualization and analytics, in stages of the process and rely on
order to ensure data integrity and that data to do everything from
sound decision-making. make decisions to advance or halt
EXHIBIT 1
Why are you using your data management solution?
  34%  
Because of regulatory guidelines
  35%  
For CPV / Proce ss and Product Monitoring
  22%  
For APQR creation
  44%  
For process understanding
  62%  
For process monitoring
  54%  
For process optimization
  46%  
For process robustness/improvement
  34%  
For process standardization

pharma manufacturers regarding

their process data solutions. The   12%   For “Golden Batch” identification
survey found that while pharma
understands the value of process
data, work still needs to be done in
  12%   For collaboration with partners

terms of adopting the right systems

— particularly systems that reduce   8%   No solution
compliance risks and inefficiencies,

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 Pharma Manufac tu rin g: Resea rc h REPORT

the development of compounds, EXHIBIT 2

to understanding the efficacy Rank the level of importance of the

of marketed treatments on following features of a manufacturing
real patients. production/process analytics solution
But as the industry’s digital
transformation progresses, Most important Least important

data is piling up. Specifically, as

Regulatory compliance capability 54% 0.8%
equipment becomes “smarter” and
more connected, more process Validation readiness 41% 2%
data is being captured. It will
Integration with lab solutions 34% 2%
probably come as no surprise to
those in the industry how much Total cost 32% 1%

of pharma is managing all of this Integration with quality solutions 32% 3%

data. According to survey results,
Complete feature set in one package 29% 2%
close to 60 percent are still using
Excel to aggregate and analyze Lot/batch/material genealogy 25% 2%
process data. Excel is universal —
Automated document generation/population 25% 2%
it’s familiar, easy to use and easy
to understand — and prior to the Initial cost 24% 2%

explosion of big data, got the job Process-centric view 19% 7%

done for pharma.
Easy data exchange with partners 18% 10%
Excel, however, has limitations
— largely tied to the fact that Dashboarding 17% 4%
it’s a very manual method for
Flexible pricing/licensing models 15% 3%
data management. The survey
also revealed that 32 percent of Web-based client 12% 9%
respondents are using Minitab, a
Multi-tenant cloud architecture 11% 10%
statistical software. The ubiquity
of Minitab is likely tied to the Single-tenant or private cloud architecture 6% 13%

prevalence — and deficiencies —

of Excel. Since Excel cannot do
the advanced statistical analyses
required in manufacturing, an
external tool is required. Minitab
is highly compatible with Excel,
allowing for auto import of data
from Excel spreadsheets into the
Minitab system. Because Minitab
is extraordinarily common in other
process industries as well as in
academia, it is a familiar choice
to many entering the pharma
industry from universities or
other companies.
Just under 19 percent of those
surveyed noted the use of in-house
or bespoke systems to manage
data. This too is not surprising, as
traditionally, software models in
pharma involved the purchase of
multiple commercial off-the-shelf
software packages, installed on
internal systems. In order to meet
the complex, specific needs of the
pharma industry, these multiple
systems were cobbled together
internally by onsite IT staff. This of
course becomes problematic when
it comes to updating or expanding
the use of these systems.

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 Pharma Manufac tu rin g: Resea rc h REPORT
For pharma, the noted
methods of data management
largely represent “how it’s always
been done.” Culturally, change
in pharma can be difficult.
Financially, change is often
perceived as costly. But this
unwillingness to change does not
come without obstacles for the
industry, many of which were
highlighted in our survey results.
SURVIVAL CHALLENGES
Not surprisingly, pharma’s cur-
rent state of data management has
resulted in myriad struggles.
The situation is further compli-
cated by a lack of consistency when
it comes to implementing data
management systems. Just 36 per-
cent say they use the systems they
identified for “some” products and
processes, while 23 percent say they
use only the data solutions for a
“select few” products and processes.
Under 41 percent report using the
solutions identified to manage all
products and processes.
Additionally, data management
techniques vary by production site.
Only around 42 percent are using
the solutions identified across all
their company’s sites. Included
in this number are the rare six
percent that are using the same
system across their entire network,
including partners. This highlights
a huge missed opportunity in
terms of collaboration. Companies
that are able to share quality data
between different teams, functions
and partners reap substantial
strategic benefits. Disjointed
systems limit a company’s
ability to improve productivity
and efficiency.
In terms of specific challenges
related to aggregation and analysis
of process data, 61 percent of those
surveyed say they still have data on
paper — the top challenge noted.
This was followed by 42 percent
who struggle with validation. This
is a situation where one challenge
leads to another. Paper-based
validation is a tedious, time-con-
suming process that requires a
significant amount of resource
commitment from the validation
and document management teams.
It also creates delays in releasing
critical manufacturing equipment
for manufacturing operations.
This type of validation also
increases risk. If Excel spreadsheets
are being utilized, as is often the
case, they need to comply with a
number of requirements. Controls
are quite often inadequate and this
may result in compliance risks.
Many respondents also noted
disconnects, pointing out that data
aggregation and analysis are done
in separate systems that are not
integrated (33 percent), disconnects
on departmental levels (30 percent)
and data silos (28 percent) — all
are perils of manual systems where
collaboration is difficult, slow
and inconsistent.
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MOTIVATORS
In order to more closely explore
pharma’s data management strug-
gles, it’s important to understand
the reasons behind pharma’s use
of specific data management
solutions. (See Exhibit 1). Con-
sidering how highly regulated
the industry is, it’s interesting to
note that survey results show that
the desire to better control the
process (in the form of process
management, process optimization,
process improvement and process
understanding) eclipse regulatory
compliance as a prime motivator.
What this likely reflects is that
pharma is no longer just managing
data for the sake of compliance; the
industry seeks to go beyond this
and derive insight and improve-
ments from this data. Of course,
compliance remains top of mind:
When it came to ranking features
of a manufacturing production/
process analytics solution (See
Exhibit 2), half of respondents
say that “regulatory compliance
capability” (electronic records/
signatures, audit trails, user/device
controls, etc.) is the most important
feature needed in a solution. “Val-
idation readiness,” a feature closely
linked to compliance, is also being
prioritized by the industry. Other
standouts in the results affecting
the decision-making process for
data solution choice were costs
(initial and total), completeness of
the feature set, and single-tenant
 Pharma Manufac tu rin g: Resea rc h REPORT
or private cloud architecture.
These latter responses could be
interpreted as disconnect between
what pharma companies expect to
pay for a data solution and what
vendors are able to provide at that
price point. Alternatively, they
may simply highlight the common
drivers in our industry and reflect
the trend toward high ROI, plat-
form-based solutions.
COMPLIANCE AND BEYOND
Predictive modeling represents the
next-level in data management,
offering an accurate and
efficient method of applying and
interpreting data. Predictive
process modeling uses advanced
technology to make predictions
about process points, such
as performance indicators or
quality attributes, with the goal
of improving and optimizing
processes. Today’s predictive
modeling software allows users
to flag risks in real time, thereby
reducing or eliminating them.
Unfortunately, pharma can’t
reach this level of data management
by using manual-based systems.
Although modeling is relatively
established in API-production,
most pharma plants still lack the
data infrastructure required for
predictive process modeling.
Survey results indicate that much
of pharma has not reached the
predictive modeling stage — 41
percent responded as such. Some
companies report applying pre-
dictive modeling in specific areas
only, such as adjusting process
conditions based on raw material
characterization, forecasting cam-
paign outcomes for supply chain
purposes or correcting downstream
operations based on upstream
process conditions (the most popu-
lar reason).
A shared predictive modeling
environment — where teams can
collaborate effectively to bring
better treatments to market faster,
at lower cost and in a way that is
completely auditable and compliant
— requires giving up manual-based
systems and transitioning to a digi-
tal technology platform.
THE NEXT STEPS
In pharma, there is often a gap
between aspirations and actions.
When survey respondents were
asked how they felt their compa-
nies were doing meeting quality,
productivity and profitability
objectives for manufacturing, many
(56 percent) acknowledged that
there were still deficiencies, noting
that their “company needs to do
more with process understand-
ing to meet its objectives.” When
broken down by manufacturing
sectors, those focusing on small
molecules were the least satisfied,
with 64 percent feeling that their
companies need to do more. This
awareness is an important first step
towards improvement.
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The better news is that 28 per-
cent are in fact taking action,
reporting that they are currently
expanding use of their data man-
agement solutions.
At the same time, around 41
percent feel confident that their
companies are “on track with pro-
cess understanding and meeting
its objectives.” This was further
corroborated by the 49 percent
who report “no plans to change”
their current use of data manage-
ment solutions.
It’s encouraging that more than
half of respondents acknowledged
their company’s need to do more
with process understanding to
meet its objectives, and reflects
a growing understanding of the
importance of data as a key busi-
ness asset. But a large percentage
of the industry still remains either
unaware of or unconvinced of the
value of solutions that can reduce
inefficiencies, risks and costs.
There is often a perception that
the costs to change to a different
system are higher than the poten-
tial payoff — in pharma, many are
still disconnected from the value
that such a change would bring to
their business and their customers.
This value can come in many
different forms. In the quality
assurance and control area, com-
panies can use new data-driven
technologies to better understand
how input parameters such as
machine settings, operator training
 Pharma Manufac tu rin g: Resea rc h REPORT
levels, or raw material options
will affect product quality and
outcomes. On the plant floor, dig-
ital operations reduce the risk of
human-error. In the supply chain,
pharma operations executives can
leverage big data, external and
internal indicators, and machine
learning algorithms to better
EXHIBIT 3
What types of products does
your company manufacture?
  28.9%  
APIs
  25.6%   26.7% Quality / Regulatory
Small Molecule
  30.6%  
Biologics
  9.9%   Personalized Medicine
  28.9%  
Combination Products
  38.8%  
Generics/Biosimilars
  17.4%  
Other
forecast demand, and automatically capitalizing on the benefits offered
identify and mitigate supply risks. by new data solutions. p
Big data is getting bigger by the
minute, and there is tremendous — Karen Langhauser,
potential for process improvement Chief Content Director,
Pharma Manufacturing
hidden in these piles of data.
Recognizing this is the first step
— but truly evolved data manage-
ment requires going beyond this,
SURVEY DEMOGRAPHICS
EXHIBIT 4
Which functional area most closely
matches yours in your company?
17.5% Mfg / Process Sciences
and Technology
12.5% Manufacturing
10.0% Product /
Process Development
7.5% Corporate Management
6.7% Supply Chain
5.0% (Technical) Operations
4.2% Information Technology
4.2% Project Management
4.2% Automation Engineering
1.7% Other
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