At Adents’ recent serialization innovation summit we spoke to Andrew Whytock, Head of Digitalization and Innovation, Pharmaceutical Business at Siemens, about digitization and how it’s influencing the future of medicine in labs around the world today.
What are you most excited for in terms of pharma’s
future and the digitalization of manufacturing?
Andrew: “At a personal level, the real interesting thing is
precision medicine. Some call it individualized production - so smaller
batches. Today we take one headache tablet, but tomorrow you may be able to
have your own flavors, or something tailored to your genetic makeup. As
research progresses, we’ll be able to have different therapies for different
types of patients. The benefits of precision medicine are quite clear.
“That’s exciting in terms
of providing care to patients with rarer diseases. It’s also exciting looking
at suppliers to manufacturers – how to completely change the manufacturing
landscape in terms of the types of companies and the ways they are approaching
manufacturing when they construct new production facilities.”
How are processes in drug discovery and pharma logistics becoming more
digitized, and how will this benefit the patient?
Andrew: “In terms of
benefiting the patient, one of the key challenges is the cost of medicine, and
this is both a political and an economical challenge. We hear quite a lot about
how the authorities want to drive down the costs of pharma, because big
pharma’s making so much. Whether the latter is true or not is a different
point, but the cost of medicine is high, and even though I’m excited about
individualized medicine, when it’s £200,000 or £300,000 per treatment, then not
many people can afford that themselves and no health authority or insurance
company will pay for that either.
“We need to drive
efficiency in research and development, which includes clinical trials and also
the way we use patient and clinical patient data to understand how we’re going
to manufacture our final drug. I’m not
an expert on the clinical side, but I strongly believe that there’s a lot of
inefficiency in that area, which is partly due to regulation and also partly
due to the way companies are set up.
“At a manufacturing level, we are helping Biontech to upscale and individualize production. When you can industrialize a very specific process, then you can make the cost of medicine much, much lower to benefit the patient.”
How will digitization change the role of manufacturing professionals?
Andrew: “In terms of manufacturing, I think what we’re seeing is a
drive towards intelligent automation for repetitive processes. We’re seeing more desire for automated
operations, where an operator is controlling the machines. Although the technology is there, it’s a
difficult area to realize in pharma because of the regulatory aspects.
“I strongly believe we
still have a requirement for people to operate, monitor and control what’s
actually happening. Systems can only take you so far.
“Earlier in my
presentation I provided the example of GSK and their digitization lab. They are
really focused on making it as easy as possible for the operator to have the
right information at the right time rather than forcing the operators to gather
data from various locations and sources.
“For a member of the
general public if they need a piece of information they can access it within
seconds from the internet. This level of transparency and access to data is not
there at all in the manufacturing environment, across most industries. How do
we improve that? That lies within the whole infrastructure, for example how do
you embrace the cloud to use and share data across different disciplines?”
Looking at product innovation, how can
digitization help contribute to more innovative products coming to market?
Andrew: “I’d bring it back
to collaboration on access to data. Big pharmaceutical companies have R&D
people internationally distributed and fail to communicate often very well.
“Communication and
collaboration tools can help to understand what experiments have already been
done, for example in another site, extending all of this knowledge outside of a
siloed organization, such as to academia. Global collaboration and
cross-sharing of information, can really lead to better understanding and more innovative
products.
“A challenging cultural
change is required, in order for most
industries to really share research and data online– I would argue that’s
culturally difficult, even if the tools are there today.
“Scientists are focused
on the science and what’s going to happen in the process. They don’t care as
much about sharing experiments or about recording it properly. They just want
to find that desired hit or reaction to assist the new medicine or document the
effect. And that’s it, and that’s their focus. To force them or ask them to
record that in a nice, structured way, which will take extra time – they’re not
interested.
“We have the tools
available today to record and structure data; and the industry is making it
simpler. So then the challenge becomes: there are too many different tools and
too many different standards. The key then is standardization, whether that’s
intra-company or cross-company – these are challenges that I see happening
around that data.
“For me, it really comes
back to collaboration, simulation and analytics; these are the three areas. You
can apply that in the different disciplines that we have. We could do more simulation in research and
development without having to do actual tests on animals or people. But you’ve
got to build those empirical models, of course.”
Definitely. I’ve noticed the EMA
lobbying for more simulation to be utilized where possible to reduce the
burdens placed on animal models.
Andrew: “Yes, and this is the point I was making earlier, which is that the regulators are actually encouraging companies now to do that – to change, do things more intelligently and use the tools there. It’s always been a, let’s call it a particularity, of the pharmaceutical industry to hide behind regulation and the regulators.”
Want more? Digitization in pharma & how is Microsoft advancing medicine?