Cybersecurity protects clinical trials

In today's fast-paced and ever-changing world of pharmaceuticals, we understand the criticality of robust cybersecurity measures like never before. As we witness the industry's relentless pursuit of accelerated manufacturing processes and the rising global demand for life-saving medications, safeguarding personal and company data has become an increasingly formidable task.?

In this issue of Discover Digitalization, we introduce you to?the Medicines Manufacturing Innovation Centre in Glasgow, Scotland, and their way to revolutionize patient care. The center is led by?CPI, a UK-based independent deep tech innovation organization that brings together pharma giants and more than 25 technology companies to fast-track clinical trial manufacturing.?Explore how?CPI’s Medicines Manufacturing Innovation Centre?are tackling major industry hurdles in cybersecurity, supply chain optimization and cost management, through utilizing our technology such as Digital Twins and Industrial Automation.

The importance of cybersecurity

The process of manufacturing medicines for clinical trials is known for its complexity, lengthy timelines, and significant costs. As the global demand for medicine continues its upward trajectory, the pharmaceutical industry finds itself under immense pressure to expedite production cycles. Enter the Medicines Manufacturing Innovation Centre in the UK—a visionary initiative designed to alleviate this pressure. Dave Berry, Head of Digital Business Systems, at CPI’s Medicines Manufacturing Innovation Centre, elaborates, "We operate a model in which the pharmaceutical industry and its supply chain work together to identify and overcome major industry hurdles – or Grand Challenges – to reduce the time, resources, and cost of medicines manufacturing – to ultimately deliver benefits to patients."

Industry problems, digital solutions?

So, can industry problems within the pharmaceutical industry be solved through digital solutions? It turns out, yes. As a greenfield site, the center is leveraging the potential of Digital Enterprise to tackle these challenges using the latest Siemens technology. The Digital Twin created with Tecnomatix Plant Simulation, for example, allows pharma companies to implement the automation module that they need, to conduct tests, and avoid bottlenecks. “Modeling allows us to stay within tight specifications,” Dave Berry says. “From a Grand Challenge perspective, we are reducing waste.” Further to this, a paperless Opcenter Execution Pharma, combines a manufacturing execution system (MES), automation and enterprise resource planning into one, which informs personnel how and when to execute each step. This helps speed up the process to real-time release, while ensuring full compliance.?

Secure automation?

We at Siemens have seamlessly integrated the industrial automation system across all layers, from the demilitarized zone (DMZ) and network to the MES, down to the control level. A remarkable feature of our technology is the Simatics RTLS (real-time location systems), which efficiently track materials, significantly reducing the time required to locate parts and objects while optimizing inventory management. Moreover, we have taken a proactive approach to security by deploying Simatic controllers with integrated security functions. This, coupled with the comprehensive digital automation services facilitated by the Totally Integrated Automation Portal, establishes a solid foundation for a secure IT/OT (operational technology) environment.??

Fully integrated Defense in Depth security approach?

At Medicines Manufacturing Innovation Centre, where there’s the potential to manufacture clinical trial batches all the way down to the individual level, security is paramount. Protecting personal and company data in this era of cyberattacks is crucial.?Addressing this concern, Michael Metzler, Vice President of Horizontal Management Cybersecurity for Digital Industries at Siemens, extends his reassurance by saying that: “Siemens’ Defense in Depth security approach provides comprehensive and extensive protection on three levels – the plant, the network, and the system – leading the way to a secure Digital Enterprise."?

Compliant to EU and UN standards?

Siemens’ cybersecurity approach complies with both the UN-endorsed IEC 62443 standard and the new NIS 2 EU cybersecurity directive. Siemens Industrial Cybersecurity Services conducted special training for the center’s employees to increase awareness.??

Optimizing sustainably into the future?

With its operations secure, the team at the center can focus on swiftly optimizing. “To improve really quickly, what we have to do is create a lot of waste. By automating and digitalizing processes, we can reduce that waste,” adds Dave Berry. “From a sustainability perspective, what we can't do really very well as an industry yet is look at Scope Three Carbon Emissions. By creating a bubble where we readily and rapidly understand digitally what's happening in Scope One and Two, it enables us to work out the best methodology for implementing Scope Three within the pharma industry. I’m really excited about working with Siemens to help get that done,” Dave Berry concludes.?

Discover Digitalization???

Our LinkedIn newsletter contains a broad variety of topics that surely are of interest for decision makers in industry: Digital Enterprise, Sustainability, Digital Twin, IT/OT Convergence, Cybersecurity, and Ecosystems. In our next issues we will dig deeper into these topics and give you the best insights on how to successfully manage your digital transformation.???

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