## 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

- ### » REAL CASEs: **Grifols, fresenius kabi, recordati, mabxience**

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.

- ### » proven AI Use Cases in pharma manufacturing

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

- ### » a high level discussion. all signal, no noise

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.

- ### » rapid analytics prototyping session

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

- ### » A Framework for Proving ROI to Leadership

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

- ### 07:45 am  
**Guest Reception & Registration**

- ### 08:00 am  
**Opening Remarks: GMP AI: Reality vs Hype**

- ### 08:30 am  
**Exploring Real-World Use Cases With P&L Impact**

- ### 09:30 am  
**Data Readiness For AI in Pharma Manufacturing**

- ### 10:10 am  
**Compliance & AI: Navigating the New Regulatory Landscape**

- ### 10:40 am  
**Fireside Chat: GMP & Data Integrity Validation**

- ### 11:30 am  
**Scaling AI: From Pilot Programs to Operationalization**

- ### 12:00 pm  
**Executive Lunch Break**

- ### 01:00 pm  
**Guided Tour of Sant Pau Modernist Complex**

- ### 02:00 pm  
**The World is Shifting: The Challenges Facing CDMOs**

- ### 02:30 pm  
**Workshop: Building Analytics Applications With Agentic AI**

- ### 03:30 pm  
**From Paper to Digital at Speed: Three Shop-floor Stories with Grifols, Fresenius Kabi and mAbxience**

- ### 04:45 pm  
**Open Discussion Forum: AI in GMP Manufacturing**

- ### 05:30 pm  
**Closing Remarks**

- ### 06:00 pm  
**Executive Networking Dinner**

### Who you’ll meet and network with

### Speakers

**Davide Botta, Recordati**  
Site Director

**Luis Fontanetti, mAbxience**  
Site Director

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**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.