IT Organizations in the Digital Era

The curative power
of big data
SAM MANTLE,
GLOBAL HEAD, RESEARCH &
DEVELOPMENT IT, NOVARTIS
Technology is changing at a speed we could never have imagined even
ten years ago. In the pharmaceutical world, technology has been integral
to business-as-usual for some time now and science and innovation is at
the heart of Novartis’ R&D function. IT, on the other hand, functioned as
a means to support business operations until recently. Today, however,
IT plays a central role in the R&D function, dictating everything from
the way we use information to how we make decisions based on that
information.
IT has become a key strategic enabler for Novartis, helping us transform
and innovate in several important areas, including:
• gene sequencing, drug discovery and pre-clinical phases;
• core clinical development to run large-scale trials in a validated and
compliant way;
• managing our pharmacovigilance requirements by capturing adverse
events and doing proactive signal detection as we seek to obtain
compound and product approvals from regulatory bodies;
• the entire submission process, which consists of collecting information
from clinical trials, validating that against the protocols and presenting
it in a transparent way to the regulatory authorities who make drug
approval decisions.
All these are key areas where Novartis procures the most sophisticated
applications and tools available in the market to help us reduce
throughput times, make processes more efficient and enable access to
a myriad of data and information.
THE ROLE OF IT IN PHARMACEUTICAL RESEARCH
AND DEVELOPMENT
At Novartis, we focus keenly on shortening the time it takes to get
our products to market. Historically, this process has been very timeconsuming
because of the lengthy processes involved from discovery
to approval. Now, however, the IT market offers us new technology
solutions that not only incorporate all the standard processes of the
pharmaceutical product life cycle, but also have capabilities to access
upstream and downstream information to help simplify and speed up
decision-making.
One such solution is in clinical trial enrolment. For example, when we
think about starting a trial, a key factor is deciding where to run it – in
which country, which site, and with which investigators. These are factbased
decisions that we can make more quickly when we have better
information about the past performance of trial countries, sites, and
investigators. IT can help us rapidly design a trial protocol and select the
right site and investigators to access to the most appropriate patients
and reduce research time.
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