Putting Emerging Technologies to Work
One of the most compelling aspects of this Pharma 4.0-focused track is how the sessions translate digital strategy into projects and measurable outcomes.
“Advanced Digitalization in Personalized Medicine”
Personalized medicine brings unique digital challenges. Integrating real-time patient data and production systems can reveal hidden gaps in your digital architecture and expose weak communication between teams. But by focusing on technology interoperability and establishing clear, patient-centered data strategies, organizations can make digital investments that deliver real impact.
In this session, Pravin Sail (BioNtech) explores how personalized and cell-based therapies are redefining performance metrics in pharmaceutical operations. This presentation will feature success stories that outline how organizations can build actionable digital threads by focusing on integration rather than isolated technology upgrades. This integrated approach can connect enterprise systems and external partners to avoid fragmentation and support evidence workflows, ultimately driving both operational excellence and ultimately better patient outcomes.
Takeaway for attendees: Understand how to pivot from siloed dashboards to integrated digital frameworks that support personalized production and accelerated decision-making.
Facility Design and Modular Architecture
“Designing a Digital Native Biotech Facility”
Jessica Mayne from Eli Lilly and Company’s Limerick Next Generation Biotech facility shares an in-depth case study of a greenfield project built from the ground up with digitalization at its core. With fully integrated electronic batch records, manufacturing execution systems, automation, and analytics, attendees can see firsthand how a digital-first approach enables right-first-time execution and makes scale-up easier for multi-product environments.
“First Commercial MTP-based Modular Plant in a GMP Environment”
Sebastian Härtner (Merck KGaA) and Thomas Makait (MTP4Pharma®) explain the implementation of the first commercial modular plant based on modular type package (MTP) standards. This session spotlights the benefits of a true plug-and-produce plant, made possible by an integrated approach to computerized systems validation.
Takeaway for attendees: Gain a practical understanding of modular design approaches and how they lead to faster qualification, changeover flexibility, and reusable engineering assets.
Driving Operational Intelligence with Data and Models
Several sessions focus on data as a strategic asset, not only as a record-keeping requirement. Harnessing data drives performance, resilience, and predictive capabilities.
“Smart Manufacturing and SmartSkin Twins Integration at Sanofi”
This presentation reveals how digital container twins and Internet of Things connectivity support real-time operations and analytics. Sanofi and SmartSkin Technologies share data showing sharp reductions in defects and demonstrate how advanced digital twins can scale value across products and facilities.
“Virtual Engineering for Pharma: From Design to Validation”
Representatives from Novo Nordisk, Aerotak, and Siemens Digital Industries Software demonstrate how simulation and virtual engineering tools can optimize material flow, streamline warehouse logistics, and even replace certain physical qualification tests—all within a compliant, GxP-regulated framework.
Takeaway for attendees: Learn how digital twin methodologies and virtual design tools can reduce risk, accelerate qualification, and broaden the use of simulation in regulated settings.
Full Lifecycle Digital Transformation Journeys
“Driving Pharma 4.0: A Strategic Digital Transformation Journey”
Henrik Baran of Boehringer Ingelheim Vetmedica GmbH details how a global supply and operations organization built and scaled its Pharma 4.0 program. From initial assessment to sustainable operational models, this session provides frameworks for planning, executing, and governing digital transformation at enterprise scale.
“Pharma 4.0 in Action: Autonomous Robotic Cell Therapy Manufacturing”
In a standout case study showcasing collaboration between Cellular Origins, UK Cell & Gene Therapy Catapult (CGTC), and PM Group, this session demonstrates how modular robotic automation can transform cell therapy manufacturing. The goal: remove manual variability and establish connected, scalable workflows.
This presentation reflects a shift taking place in real-world projects: robotics is finally moving from hype to practical adoption in personalized medicine. In cell therapy manufacturing especially, robotic systems are reducing manual variability and enabling the scalable, connected workflows the industry has been working toward for years. “It’s a pivotal moment that’s driving meaningful, long overdue change,” shared Yvonne Duckworth (CRB), 2026 ISPE Europe Annual Conference International Program Committee Member.
Takeaway for attendees: Learn strategies for integrating robotics and digital execution in complex, high-value therapeutic contexts and discover frameworks for bringing these technologies to future plants.
From Data to Decisions: Smart Maintenance and Value Realization
“Leveraging Production Data for Smart Maintenance at Xellia Pharma”
Magnus Liisberg (Omron), Christian Paaske (Xellia), and Stefan Jensen (Optipeople) share how real-time production data and cloud analytics were leveraged to build predictive maintenance systems that reduce downtime, cut waste, and support compliance.
The 2026 ISPE Europe Annual Conference International Program Committee is especially pleased to highlight a local Danish company (Xellia) showing how real time production data and cloud analytics can make predictive maintenance a practical reality—reducing downtime, cutting waste, and strengthening compliance.
“Beyond the Hype: Delivering Value from Pharma 4.0 Investments”
Gianpaolo Orlandi (Wood Italiana) and Peter Carydias (Wood[KL1.1]) introduce a practical, compliance-embedded seven-step methodology that helps companies quantify risk and value before initiating their digital transformation journey.
Takeaway for attendees: Get frameworks for building business cases, ensuring compliance by design, and measuring return on investments from digital initiatives.
Why You Should Attend
The Pharma 4.0 in Action track is more than a collection of technical presentations. It is a curated set of blueprints for implementation, full of business-ready frameworks, and proven use cases responding to real industry challenges. Whether an attendee is just beginning their digital journey or seeking to scale existing programs, this track delivers insights that can be enacted immediately.
I’m most excited to hear about the case studies in facility design and operation, especially the greenfield digital biotech project and the modular plant examples. These sessions show what is possible when teams embrace digital-first thinking: not just software, but new business models, new ways to collaborate, and new speed to market. I hope these stories inspire participants to drive bold change in their own organizations.
Laura Kuger (Takeda), 2026 ISPE Europe Annual Conference International Program Committee Member
As an automation engineer, this track is especially meaningful to me. It offers implementation ready blueprints, practical frameworks, and proven use cases that address real industry challenges. Whether attendees are starting their digital journey or scaling existing efforts, the insights shared here can be applied immediately.
Yvonne Duckworth
The lessons, tools, and frameworks shared here represent the forefront of Pharma 4.0 execution and underscore a central truth: digital transformation in pharmaceutical manufacturing is not just for the future; it is happening now.
Register for the 2026 ISPE Europe Annual Conference today.
