Five Questions for Boehringer Ingelheim`s Data Boss

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Five Questions For Boehringer Ingelheim’s
Data Boss
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By Sukaina Virji, 1 March 2016
The end of 2015 saw Boehringer Ingelheim
follow a number of its pharmaceutical peers
by bringing in an external service provider – in
technology and data analysis needs. Scrip spoke
with Klaus Stern, global head of biostatistics
and data sciences at Boehringer, to find out why
fortifying the company’s internal R&D efforts with
external cutting-edge technology was so vital.
Scrip: How has the concept of innovation changed in recent
years to make new information technology so critical?
Klaus Stern: There are several factors, but the overarching
one is that the pharmaceutical industry has to change its
business model. We are under new pressures: financial pressures, technical pressures, regulatory pressures, pressures
from payers, from the insurance companies. That is a lot
to cope with. To be successful we have to bring innovative
therapies on to the market otherwise we will not succeed.
Technology is very important to enable us to get new and
important products to market in the most time efficient
manner as possible.
Scrip: What areas of clinical development have been impacted
by new technology?
2• • •
McIek/shutterstock.com
this case Medidata Solutions – to meet its cloud
KS: We have a lot more data sources in our current trial settings then we had in the past, e.g. laboratory data analyzed
by specialized laboratories, images, biomarkers, e-COA, more
committees, and so on. This makes trials much more complicated just from a pure technical point of view, and additionally trial designs become much more complex, e.g. adaptive
trial designs. This could, from a technical point of view,
become a nightmare – and for this you need flexible tools to
be able to cope with all these different challenges.
Scrip: Give me some examples of technology that you have
implemented into your development timelines.
KS: We have a lot more electronic devices getting increasingly more data directly from the patients via a central
vendor. Direct access to health records will be a goal. We are
looking to minimize the interfaces, and to have them working automatically. We work towards metadata-driven end-toend processes, which are automatically steered by metadata
with no human intervention, meaning it is less error prone,
guarantees consistency between documents and data, and
is also of course faster.
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The other thing is that we use the data itself to steer the
trial, known as risk-based monitoring. We need the data
in real time or almost in real time to be able to steer the
trial, to look into any potential issues, so we can react immediately. We never had this before. That’s very important
because all the regulators are asking us to have oversight
of the trial at any time and to deal with the risks in a controlled manner.
Scrip: Are there further efficiencies to be had in the development process through the use of more technology?
KS: Yes I think so. Medidata has a whole suite of products
which fit together, which is essential for us. So we don’t
have to build the interfaces by ourselves. With regard to
metadata-driven processes it becomes very important that
the different systems are able to talk to each other smoothly.
And if you have a whole suite of systems which can talk to
each other then of course it facilitates the process a lot and
reduces maintenance cost.
3• • •
Scrip: Why don’t pharma companies develop these systems
in-house?
KS: The times when BI developed a system by itself are
long gone because we are not an IT company, we are a
pharmaceutical company. I trust that with a specialized
company, dealing with other pharmaceutical companies
in addition to us, that we will get better systems by buying them than if we do this by ourselves.
Of course we have had to adapt some of our processes, but
overall that’s much more efficient than doing development
ourselves. You have to understand that the outside world is
changing, and having to maintain all the interfaces by ourselves would be very labor intensive. It is not value adding for a
pharma company and confers no competitive advantage.
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Reprinted by SCRIP (scripintelligence.com). Unauthorized photocopying prohibited.