GMP AI Summit 2026 — September 14 · Barcelona

The AI pilot worked. Now it's sitting in a spreadsheet, with no roadmap to production.

The same problems show up in every program: scaling difficulties, regulatory uncertainty, data complexity, and the challenge of running and governing interconnected models in production.

01

Data architecture

AI runs on data, not slide decks. Before Recordati delivered a 1.5% yield increase, they connected SCADA, MES, LIMS, and batch records into a single layer inside a running plant. That foundation is the bridge from pilot to production.

02

Validation challenges

QA sign-off on ML in GMP demands a validation framework most teams don't have. Operationalizing AI means documenting model updates, managing drift, and holding an audit trail that survives inspection.

03

Multi-model governance

No two plants, lines, or products are alike, so every model is custom. Deploying many models and governing them all under GMP is a core barrier to operationalizing AI. It takes operational infrastructure designed for governance.

04

ROI stays invisible

Operations sees the value; finance needs it in their language. That translation gap is a consistent blocker. The fix is specific, auditable numbers tied to production outcomes, like a 4% yield gain worth more than $30M.

Why you should attend the GMP AI Summit

Get an inside look at how real pharmas and CDMOs are deploying GxP-compliant AI to unify complex operational data and drive yield optimization across their global facilities.

See exactly how industrial-grade AI is driving concrete ROI today in Deviation Reduction, Yield Optimization, Increased Capacity, and Faster Product Release.

A closed room of senior leaders from top biomanufacturing companies. Share strategies, validate your approach, and engage in structured, genuinely useful peer exchange without vendors pitching from a booth.

Build a functional analytics dashboard in minutes using real production data and agentic AI tools. Answer real questions in real time.

Learn how to prioritize AI use cases based on operational and financial impact, so you can make the internal business case with confidence based on your own data.

Agenda

Guest Reception & Registration

Opening Remarks: GMP AI: Reality vs Hype

Exploring Real-World Use Cases With P&L Impact

Data Readiness For AI in Pharma Manufacturing

Compliance & AI: Navigating the New Regulatory Landscape

Fireside Chat: GMP & Data Integrity Validation

Scaling AI: From Pilot Programs to Operationalization

Executive Lunch Break

Guided Tour of Sant Pau Modernist Complex

The World is Shifting: The Challenges Facing CDMOs

Workshop: Building Analytics Applications With Agentic AI

From Paper to Digital at Speed: Three Shop-floor Stories with Grifols, Fresenius Kabi and mAbxience

Open Discussion Forum: AI in GMP Manufacturing

Closing Remarks

Executive Networking Dinner

Who you’ll meet and network with

Speakers

Davide Botta, Recordati
Site Director

Luis Fontanetti, mAbxience
Site Director

.png)](https://www.linkedin.com/in/jgubau/) Pep Gubau, Aizon
Founder, CEO

Marc Llurba, Grifols
Global Program Manager Smart Factory

Toni Manzano, PhD, Aizon
Founder, Chief Science Officer

Cristian Marfà, Aizon
VP of Technical Sales

Jaume Mir, Grifols
Digital Manufacturing MES Lead

Dr. Jutta Valkenberg, Fresenius Kabi
SVP Digital Transformation

Scott Waldman, Aizon
Board member, CSO Lonza (former)

David Wallace, Biophorum
Senior Director

The Venue: Sant Pau Modernist Complex

Barcelona · UNESCO World Heritage Site

Designed by Lluís Domènech i Montaner, Sant Pau Recinte Modernista is one of the most architecturally significant buildings in Barcelona, and the perfect location to bring together leaders who ultimately serve the patient. As part of the event, you will get to enjoy a private tour of this remarkable architectural landmark.