Siemens’ Head of Digitalization in Pharma talks the future of pharma manufacturing

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.”

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