This year offers the combination of having the Pharma 4.0™ Conference and the Biopharma community together under one roof. “For a long time, digital transformation and biopharma were treated as separated audiences,” Zeitz says. “In practice, the hardest business transformation work happens exactly where they overlap — that’s the conference we built.”
“Pharma 4.0™ tells you how to build it, biopharma tells you what you are building,” Pelleboer adds. “Put those two at the same venue and you stop running pilots and start running processes.” The how is the data, the architecture, the governance, and the compliance model that make transformation hold up. The what is the molecules, modalities, and business processes that have to be developed, manufactured, and released. Pharma 4.0™ is not a digital layer bolted on top of biopharmaceutical manufacturing — it runs end to end through every part of the pharmaceutical product lifecycle and its holistic control strategy, from upstream process development through tech transfer, commercial manufacturing and aseptic fill-finish up to final batch release.
The program was shaped by an open call that drew well over a hundred submissions, reviewed by a Committee spanning operating companies, consultancies, and technology partners. Six objectives guided the selection — connect, create, consolidate, collaborate, communicate, and catalyze — with a consistent bias towards sessions that pair technical depth with implementation reality. “Never start with technology; start with company objectives,” Pelleboer says.
The week opens on Wednesday 9 December with a Takeda-hosted hackathon and facility tours at Charité and Bayer, alongside a Pharma 4.0™ interactive training workshop that brings everyone to the same starting level on the fundamentals. Two keynotes then anchor Day 1 — biotechnology as an economic driver for Europe, and self-driving biolabs accelerating bioprocess development — We close the day with an expert panel on the next step of corporate interconnectivity in Pharma 4.0, the Pharma Open Data Space / PODS”. Day 2 opens with a keynote on continuous biomanufacturing.
Three Tracks
Sessions run in three tracks across both days, moving from digital foundations to regulatory compliance to applied biopharmaceutical manufacturing. Each track stands on its own, and delegates can move between them.
Track 1 — Enabling Digital Foundations, led by Yvonne Duckworth and Maja Karovic on Day 1 and Christian Wölbeling and Kim Hewson on Day 2, covers the building blocks: data readiness, interoperability, digital architecture, and governance. Sessions look at how strong foundations translate into transparency, better decision-making, and operational resilience. “AI maturity will never exceed data maturity,” Pelleboer says. “If data is fragmented, inconsistent, or manually handled, AI simply cannot scale.”
Track 2 — Compliant by Design, led by Markus Zeitz and Rene-Pascal Fischer on Day 1 and Francesco Cicirello and Vinzenz Zauner on Day 2, deals with compliance. It spans the full arc from trusted data infrastructure and AI-driven quality operations through to inspector expectations in an era of electronic evidence. Industry leaders and regulatory voices set out what it takes to move from transformation intent to inspection-ready operations, including emerging requirements for ATMPs and AI in GxP environments.
Track 3 — Pharma 4.0™ in Action, led by Lineke Pelleboer, Laura-Ann Chin, and Kristen Seemann, applies the first two tracks to biopharmaceutical manufacturing. Sessions cover traditional biologics, plasma fractionation, aseptic fill-finish, and advanced therapy medicinal products including cell and gene therapies, drawing on case studies and lessons learned from real implementations. Industry experts examine how trusted data, advanced analytics, AI, and integrated robotic platforms improve process performance, sharpen decision-making, and strengthen deviation management — always augmenting human expertise rather than replacing it.
Berlin is a fitting setting: a hub for European biotech and pharmaceutical manufacturing, home to Charité and a dense network of industry players, and a city that reflects the same convergence of scientific depth and digital ambition the program is built around. For leaders in quality, IT, manufacturing, and engineering moving fast on digital and AI while keeping compliance and reliability intact, the two days offer case studies, peer conversations, and regulatory perspective. “If people leave Berlin with one thing, it should be a concrete answer to ‘what do I do Monday morning,’” Zeitz says, “not another slide deck on why digital transformation matters.” Pelleboer and Zeitz, with the full Committee, welcome the industry to Berlin this December.
Learn more about the 2026 ISPE Pharma 4.0™ and Biopharma Conference.
