Welcome Session

Our CMO, David Medina, will welcome the attendees and go over the agenda and everything about the event.

From Digital To Intelligent: The New Era In Life Sciences

Drawing on Axendia’s latest research on the expanding role of Artificial Intelligence in Life Sciences, this keynote will explore how leading companies are shifting from systems of record to systems of intelligence. It will highlight the capabilities required to accelerate time to market and time to volume while maintaining quality, compliance, patient outcomes, and operational resilience in an increasingly disrupted global environment.

How Much Should You Trust Your AI? A Framework for Autonomy in Pharma

From document drafting to autonomous process decisions, AI capabilities in pharma are outpacing governance frameworks. This session gives you a practical three-tier model to evaluate where AI should advise, where it should assist, and where it can act - and what each level demands.

Fireside Chat: Meet one of ValGenesis VAL AI Customer 

A fireside chat led with a ValGenesis AI customer discussing their experience, challenges and outcomes using ValGenesis VAL

The Pharmascience Digital Validation Journey

Sarah Forrest of Pharmascience shares how the company scaled ValGenesis across the enterprise and leveraged the platform in support to a major site-expansion for commissioning and qualification activities.

Panel Discussion: Powering Life Sciences with Digital Innovation 

Digitalization and emerging technologies are transforming the life sciences industry, enabling more efficient research, manufacturing, and quality processes through tools such as AI, advanced analytics, and connected systems. This panel will explore real-world applications, key challenges, and how organizations can leverage these innovations to accelerate development, improve compliance, and drive future growth.

Meet the Panel:

Fabrizio Maniglio, ValGenesis (Moderator)
Hitto Kaufman, Hansa Biopharma
Daniel Matlis, Axendia, Inc.
Fabrice Odille, UCB S.A. Elisa Valenti, Chiesi

Case Study - Digitalizing Quality by Design Framework at UCB

Fabrice Odille will discuss how UCB leveraged ValGenesis to digitalize and streamline process and analytical development through the application of Quality by Design (QbD) and Quality Risk Management (QRM) best practices.

Digitalizing Cleaning Validation

A discussion and demonstration of how iClean is more than a paper-to-glass solution, digitalizes the entire cleaning validation lifecycle—from risk-based planning and MACO determination to execution and ongoing requalification, ensuring that cleaning validation is always up to date.

TBA 

More details to come.

The ValGenesis Customer Experience

Ângela Martinho will share how the Digital Transformation team helps organizations maximize the value of their ValGenesis solutions while building a clear path for long-term digital transformation. The session will highlight how a strategic approach to that transformation can drive optimization, accelerate adoption, and support scalable business outcomes.

Closing Remarks