Enterprise connectivity: from lab to leader
Clinical data can be expansive and complex, so how can business executives make sense of the information to take the best decisions for their company? Kim Shah, vice president of marketing and new business development for informatics at Thermo Fisher Scientific, investigates the role of enterprise connectivity solutions.
One of the key
challenges faced
by life sciences
companies is the inability to
turn the growing volume of
laboratory-generated data
into useful information
that enables management
to make timely and effective
decisions. With multiple
applications across the global
enterprise generating reams
of data that sit in separate
silos, aggregating and
mining this data is a complex
problem. In some parts of
many companies, manual
processes are still being used
for collecting, analysing and
reporting this data. More
often than not, creating the
reports necessary to distill
this vast amount of data into
relevant information can be
tedious and time consuming.
If a scientist is performing
the administrative tasks of
creating reports in order
to make sense of the data
collected, then that company
is losing time and money
in activities that are not
furthering scientific lab
work. Because data formats
and applications are often
inconsistent and not well
integrated across instruments
or applications throughout
the organisation, there has
been no coherent way for
scientists to aggregate all
of their work in one place.
These barriers stand in the
way of life science executives
as they try to make the most
effective business decisions
in an economic climate that
demands scrutiny of every
possible opportunity for
efficiencies and cost savings.
To address these barriers and
to facilitate improved decision
making across all levels of
management within a life
sciences company, Thermo
Fisher Scientific is leveraging
its wide range of capabilities
to help bridge the gap
between laboratory-generated
data and the enterpriselevel
information that is
required for mission-critical
management decisions.
| Integration challenges |
| Pharmaceutical and biotechnology
companies are facing integration
challenges, from discovery through
to manufacturing, says Thermo
Fisher Scientific’s Trish Meek. Even
as drug development costs continue
to climb, the low approval rates of
New Molecular Entities (NMEs)
remain fairly consistent. Since this
challenge will not be resolved quickly,
drug development organisations are
re-focusing their research dollars to
ensure that the right drugs move
through their pipeline.
Once a promising drug candidate
has been identified, initiatives
like translational research provide
pharmaceutical companies with the
information they need to accurately
track the performance of a treatment in
humans and correlate that information
with the results of in vitro and
animal in vivo studies. Because this
information can come from many
different sources, connecting the
sources of the data and integrating
this information into the analytical
process becomes crucial for scientists |
|
to most effectively and efficiently
interpret their data and make decisions
about new drug entities and the
therapeutic options they deliver. While
patient data comes from the clinic,
the initial laboratory data comes from
a combination of contract research
organisations and the pharmaceutical
company’s own internal laboratories.
Through outsourcing, pharmaceutical
companies are able to lower the cost
of executing studies and performing
analytical testing. Connecting all of
this information is a critical part of
the process since it will drive future
decisions about which compounds to
synthesise and test. By integrating this
information from all of these sources
and presenting it in a way that is clear
to researchers, drug development
organisations are able to make faster,
more informed decisions.
Integration of data and the connectivity
of information sources are of
enormous importance for commercial
pharmaceutical manufacturing, where
it is critical that all data is |
|
associated
with the batch record. Data needs
companies are focusing their R&D to be synthesised from the existing
ERP, PIMS, MES and LIMS to ensure
that the end product meets quality
standards and that any issues with the
product’s stability, % label claim or
content uniformity are elevated to the
batch label to prevent costly product
recalls, product loss and unplanned
downtime. The integration of this
information is even more critical in
biopharmaceutical manufacturing
where unplanned downtime is not
an option. Take for example a typical
fermentation plant, with three reactors
A, B and C. Recognising and containing
a contamination in samples from
reactor A before it is used to seed
the remaining reactors will prevent a
complete shutdown of all operations.
By integrating the sources of the data
and enabling the connectivity of the
disparate data files, the laboratory
can determine if the source of the
contamination is in the reactor or was
introduced to the batch after the sample
was taken and brought to the laboratory.
Pharmaceutical and biotechnology |
Enterprise-level
connectivity
Thermo Scientific
CONNECTS is a set of
offerings that encompasses
the company’s breadth of
Laboratory Information
Management Systems
(LIMS) and Chromatography
Data Systems (CDS)
capabilities, as well as
expertise in enterprise
systems integration to help
streamline and improve
the transfer of knowledge
between laboratorygenerated
data and
enterprise-level information
systems. CONNECTS assists
organisations in designing
and integrating applicationspecific
workflows, thereby
transforming laboratory
data into relevant business
information and maximising
a company’s enterprise
system investments to better
support critical management
decisions in today’s resourceconstrained
environment.
| Integration challenges (continued) |
| investment and streamlining their
operational costs to maximise their
profitability, but also to ensure
that their companies continue to
make the greatest contribution to
human health, and in the process
building shareholder value and
consumer confidence. To do this,
they need to ensure that the right
information is available in real
time to the right people. Whether
the challenge is trying to track the
progression of a promising drug
candidate through the pipeline,
or reviewing environmental
monitoring data associated with a
batch, the solution can be found
in the integration of multiple data
sources and the visualisation
of information. |
|
The challenges outlined involve
entirely different operating and
instrument systems, with different
data formats, which necessitate a
completely different approach to the
integration process. Thermo Scientific
CONNECTS takes all of this disparity
into consideration and, with the
world-class products and services that
have been developed in partnership
with the pharmaceutical industry,
CONNECTS can bring together the
proper integration solution for the
particular challenges facing any life
sciences company. |
 |
| Thermo Scientific CONNECTS is aimed at bridging the gaps between laboratory-generated
data and enterprise-level information required for mission-critical management decisions. |
| |
Streamlining the flow of
information
Integrating the work of the
laboratory with enterprise
systems that inform
management decision
making is the latest challenge.
The CONNECTS solution
is one which will deliver not
only increased information,
but better-quality knowledge
for management, which
will lead to more informed
decisions that enable the
company to stay ahead of
the revenue constraints now
afflicting the industry. As
life sciences companies look
to streamline the flow of
information and gain more
knowledge from the data
they generate, living with
multiple disparate systems
with minimal integration is
no longer an option.
The most common sources
of data that provide
mission-critical information
include laboratory
instrumentation, informatics
software like LIMS
(laboratory information
management system), CDS
(Chromatography Data
System), and ELN (Electronic
Laboratory Notebook);
enterprise systems like MESs
(manufacturing execution
systems), PIMS (process
information management
system) and ERP (enterprise
resource planning);
enterprise communications
tools like SharePoint and
BizTalk; or document
management systems like
NextDocs and Documentum.
Having these data sources
integrated enables laboratory
management to track data
points in real time, eliminate
manual data entry and
set up automatic ways for
identifying trends, all of
which elevates the role of the
laboratory in the day-to-day,
mission-critical decisions
made by management
throughout an enterprise.
Integration of informatics
solutions with a variety
of enterprise systems is
particularly relevant for
life sciences companies in
today’s business climate
where near-instantaneous
response is required to
know the source of potential
risks, and to continuously
protect the consumer. It
is therefore critical for any
integration strategy to bring
key knowledge originating in
the laboratory to management
at all levels of the enterprise.
Furthermore, with increased
pressure to cut costs and
shorten the pipeline lifecycle,
life sciences companies are
looking for tools that allow
them to communicate better,
make decisions faster and
report on how compounds
are progressing in drug
development.
Companies like Thermo
Fisher Scientific, offering
an end-to-end solution
for the integration of
various instruments and
systems, along with the
interoperability necessary to
transform data into relevant
business drivers, are able
to help their customers
expand the business of
science from the laboratory
throughout the enterprise.
By effectively integrating
laboratory informatics data
with enterprise systems, life
science executives can have
access to the right data and
thereby make better business
decisions. |
 |
Company profile
Thermo Fisher Scientific is the
worldwide leader in laboratory
software and related services,
providing enterprise-wide, multilaboratory
solutions that are
relied on at the world’s largest
enterprises, including those in the
biotechnology, pharmaceutical,
petro/chemical, food processing,
mining and forensics industries.
To support its Thermo Scientific
informatics installations, the
company provides implementation,
validation, training, maintenance
and support from the industry’s
largest informatics services
network. For more information, visit:
www.thermo.com/informatics.
|
