Cyber-Physical Trust Platforms

James Kugler at EMD Digital/Merck speaks to IPT about how counterfeit drugs, regulatory pressures and supply chain vulnerabilities demand a greater level of transparency in pharmaceutical manufacturing. Cyber-physical trust platforms, which provide an immutable link between physical products and their digital twins, will set a new standard and revolutionise the industry

IPT: Historically, how has product quality and authenticity been ensured for pharma products?

James Kugler (JK): Product quality and authenticity assurances are critical to safeguarding public health. They’re also the bedrock of scientific and medical progress. The ability to trace product information to its source and to validate it provides the guarantee that one can make a verifiable claim to a medicine or a chemical compound’s authenticity.

Stringent regulatory frameworks and manufacturing standards established by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies address these requirements. They enforce strict controls on production processes, raw material sourcing and storage conditions, and regular inspections and audits help to ensure compliance with these standards.

Technology has developed over time to produce solutions that help suppliers and manufacturers adhere to those standards. Track-and-trace systems are widely used today to mark and authenticate a pharmaceutical product. Barcodes, QR codes and radio-frequency identification (RFID) are employed to track these products throughout the supply chain. Admittedly, one drawback of these technologies is that most are typically point solutions that may not seamlessly integrate with broader systems.

However, we’re now seeing how exciting, emerging technologies powered by Web 3.0 can become powerful new solutions for the pharmaceutical manufacturing industry, ensuring product authenticity at every step of the value chain – a tamper-proof digital record that accurately represents its physical counterpart. These technologies bring the added benefit of reducing the manual workload on human operators, leading to a less error-prone and more efficient manufacturing process. The complex challenges faced by manufacturers in this increasingly connected world will require companies to move from traditional manual processes to more reliable digital frameworks. Cyber-physical trust enables this digitalisation.

IPT: What is a ‘cyber-physical trust platform’ and how does it work?

JK: A cyber-physical trust platform integrates digital and physical technologies to ensure security, reliability and traceability in interactions among connected devices, systems and users. It can be thought of as an unbreakable chain of custody between a physical object and its digital representation, or digital twin.

Unlike typical point solutions that provide a single scan at one point in time, a cyber-physical trust platform enables an interconnected view across time –tracking every sample, modification and transport in an immutable ledger. This comprehensive traceability provides a layer of trust embedded from beginning to end.

The platform operates by combining novel technologies such as the industrial internet of things (IIoT), blockchain, artificial intelligence (AI), and secure hardware like readers and crypto anchors. For example, a pharmaceutical company can use this platform to track a drug from the moment it is manufactured, through distribution, all the way to the pharmacy shelf, ensuring that every transaction and interaction is securely recorded and verifiable.

IPT: How will cyber-physical trust platforms be beneficial to patients?

JK: Cyber-physical trust platforms have the potential to transform healthcare by enhancing patient safety, ensuring the integrity of medicines we rely on and addressing pharmaceutical counterfeiting. These systems can create a secure, verifiable link between a medicine – the physical object – and its digital twin, enabling both trust and transparency in healthcare.

One potential application is in precision medicine, such as CAR T-cell therapy for cancer. For these treatments, ensuring that the therapy administered to a patient originates from their own cells is critical for both safety and efficacy. A cyber-physical trust platform can verify every unique sample and track every modification throughout the multi-step development process. With the ability to audit on demand, the platform allows for real-time authentication at any step, ensuring the integrity of personalised treatments for patients.

Another application for these platforms could help address the problem of pharmaceutical counterfeiting. According to the Pharmaceutical Security Institute, drug counterfeiting is on the rise. In 2002, there were 196 reported counterfeit crime incidents, but by 2023 that number had increased to approximately 6,900.1 By immutably linking each physical product to its digital twin, cyber-physical trust platforms enable the tracking of pharmaceuticals from manufacturing to delivery. This helps ensure that patients receive only genuine, untampered medications, safeguarding public health and also reinforcing confidence in the pharmaceutical supply chain.

These two examples highlight a fundamental truth, that trust is the foundation of healthcare – without it, the system falters. By providing secure, transparent verification, cyber-physical trust platforms can play a role in benefiting and protecting patients.

IPT: In what ways can digital twins improve traceability and quality assurances?

JK: Digital twin technology offers transformative potential in improving traceability, quality assurance and regulatory compliance for the pharmaceutical industry.

Digital twins can potentially provide end-to-end visibility across a product’s life cycle, from design and manufacturing to distribution and usage. This transparency ensures accurate tracking of every step, including raw material sourcing, production processes and supply chain movements. For instance, digital twins can continuously log and monitor machine parameters, raw material usage and batch information, linking this data directly to specific products to enhance traceability.

When combined with blockchain technology, digital twins create immutable, tamper-proof records of each process, ensuring authenticity and regulatory compliance. This is particularly critical in pharmaceuticals where verifying product integrity, preventing counterfeiting and complying with regulatory mandates are paramount. In addition to compliance, digital twin technology improves quality control by automating traditional manual inspections. Machine-to-machine interactions reduce human error, providing a more reliable and auditable trail of product quality. By leveraging real-time monitoring, predictive analytics and historical data insights, digital twins can play a pivotal role in ensuring consistent quality assurance and regulatory adherence.

IPT: How can ‘Platform-as-a-Service’ technology be utilised to enhance, rather than detract from, human expertise?

JK: Platform-as-a-Service (PaaS) software can typically be easily integrated into existing workflows and processes. PaaS technology can enhance human expertise by streamlining processes, providing advanced tools and fostering collaboration, rather than replacing or undermining human capabilities. By automating routine tasks and enabling access to powerful computational resources, PaaS empowers professionals to focus on higher-value activities that require creativity, critical thinking and domain expertise. It’s these distinctly human activities that demonstrate why human expertise is still critical and more vital than ever.

Humans are the masters of context, and this helps us to determine quality. Quality enables reproducibility, and reproducibility drives the kind of scientific progress that can improve the world we live in. To determine the quality of information in the age of creative machines, we need to know what processes the information was subject to, where it came from originally and that it truly came from that place. That role lies with us. Rather than replacing human expertise, PaaS amplifies it by providing innovative tools that augment human creativity, problem-solving and decision-making capabilities.

IPT: Will cyber-physical trust platforms become integral to the pharma product manufacturing sector, particularly over the next five years?

JK: As we advance towards digitally interconnected value chains, cyber-physical trust platforms will become foundational to pharmaceutical manufacturing. These platforms provide secure, transparent and efficient systems that address critical industry needs. These needs combine with other external factors to drive adoption of these platforms – they include regulatory compliance, combatting counterfeiting, supply chain resilience and process optimisation.

As regulations evolve to demand greater transparency and traceability in manufacturing and supply chain processes, cyber-physical trust platforms offer the ability to track and trace products in real time. Take the European Union’s requirement for Digital Product Passports (DPP) that mandates end-to-end traceability, requiring manufacturers to digitally document a product’s life cycle, including materials, origin and sustainability metrics. Across the Atlantic, new requirements of the FDA’s Drug Supply Chain Security Act (DSCSA) enforce secure, interoperable traceability systems, making real-time tracking a necessity rather than an option.2 Cyber-physical trust platforms, leveraging blockchain and digital twins, enable tamper-proof documentation and automated compliance, reducing friction in regulatory audits. The pharmaceutical industry is also particularly vulnerable to counterfeit products and unpredictable supply chains. The former poses safety risks and financial losses, which can be mitigated by machine-readable authentication mechanisms integrated into cyber-physical trust platforms. These mechanisms ensure that every product is verified at each supply chain touchpoint, reducing the risk of diversions and fraud. Guarding against the impacts of increased complexity and geopolitical shifts on supply chain disruption requires real time visibility into sourcing, manufacturing and distribution. AI-driven analytics in cyber-physical trust platforms improve predictive risk management, allowing for faster decision-making and adaptation to external shocks.

Beyond compliance and security, cyber-physical trust platforms enable seamless machine-to-machine interactions, unlocking efficiency gains through automated quality control and adaptive process optimisation. With integrated informational technology/operational technology convergence, manufacturers can streamline batch releases, reduce waste and achieve real-time process orchestration, enhancing both productivity and sustainability.

To sum it up, cyber-physical trust technology will not be optional but a strategic necessity in the future of pharmaceutical manufacturing. The combination of regulatory pressure, counterfeiting risks and the need for resilient supply chains will drive industry-wide adoption. Those who proactively integrate these technologies into their smart manufacturing strategy will be better positioned to navigate regulatory landscapes, enhance product security and achieve long-term competitive advantage.

References:
1. Visit: statista.com/statistics/253150/counterfeitincidents-concerning-pharamceuticals-since-2002/

2. Visit: fda.gov/drugs/drug-supply-chain-integrity/drugsupply-chain-security-act-dscsa

James Kugler is the CEO of EMD Digital and chief digital officer of Merck, EVP of Athinia, and a member of the board of directors of Syntropy. Under the EMD Digital umbrella, James is responsible for spearheading new digital business ventures that advance Merck’s commitment to materials quality into the digital era. James continues to encourage the internal incubation of innovative businesses, particularly by representing the digital perspective on Merck’s Innovation & Technology Executive Committee (ITEC). James began his journey in science early, conducting research at Harvard and MIT, both US, while still in high school. James is deeply committed to advancing scientific quality and accelerating breakthrough technologies through digital innovation, and he is passionate about the importance of data quality and human expertise in the age of generative AI.