Life science special report 161215 IY opt

KRISTIAN DEBUS INTRODUCTION
INTRODUCTION
"The Life Sciences Sector is experiencing
an unprecedented change..."
The Life Sciences Sector is experiencing
an unprecedented change in the way
new medicines and medical technologies
are being developed. Increasingly,
visionary companies in the sector are
deploying modeling and simulation
to reduce costs, mitigate risks and
increase innovation. Ultimately, this
results in better medicines, superior
medical products and signifi cantly
improved outcomes for patients.
One big shift in recent years has been that
simulation-based product development
and virtual prototyping are increasingly
being recognized by the FDA as valid tools
to supplement experimental testing and
clinical trials, and accelerate regulatory
approval. Initiatives like the ASME V&V 40,
MDIC, or Avicenna, drive and guide these
efforts and lobby for the increased usage
of simulation for the support of benchtop
and clinical trials in the medical device
industry. Similarly, in Pharma, the move
from batch to continuous manufacturing is
being promoted by consortia like CSOPS.
This represents a great opportunity to
integrate the use of simulation early when
redesigning processes, offering the best
possible chance of maximizing ROI.
Yet, with the advancement of simulation
technology, and following the buy-in
and support by the regulatory bodies,
the most essential ingredients —
expertise and manpower — must
come from the customer. The leading
medical device design and pharma
companies have realized that investment
is critical, in terms of recruitment as
well as the technology and they have
started integrating simulation into
clinical trial studies and are applying
it to modernize their manufacturing
processes. The life sciences industry
is also reaching out to experienced
end-users in the automotive and CPI
industries to help overhaul process
engineering in big pharma and integrate
new design and testing modalities
within medical device companies.
At CD-adapco, we are fully committed to
bringing you our best-in-class solution to
help the shared vision of virtual biomed
and pharma labs become reality. We
are continuously delivering state-ofthe-art
technologies and automated
workfl ows to help close the gap between
experiments, benchtop tests, clinical trials
and engineering design. Our capabilities
today allow our customers to look at
very complex physics and geometries
and enable an application range from
medical device design all the way to
pharmaceutical manufacturing processes.
The articles in this Special Report cover a
range of applications from medical device
design to pharmaceutical manufacturing
processes. We hope they will inspire you
to make simulation an integral part of your
design and manufacturing processes and
we promise to do our part to get you there!
KRISTIAN DEBUS
Director, Life Sciences
CD-adapco
SPECIAL REPORT
3