A science-driven framework for EV characterization to achieve clinical success

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

A science-driven framework for EV characterization to achieve clinical success

This webinar will provide a science-driven framework for extracellular vesicle (EV) characterization, focusing on the principles behind defining identity, purity, potency, and safety. We’ll discuss why early analytical planning is essential for establishing critical quality attributes (CQAs), enabling process control, and building confidence in your therapeutic candidate. Learn how to apply a risk-based, phase-appropriate approach to prioritize analytical efforts during early development.

Attend for insights on key questions developers face during EV characterization, including:

Which attributes truly matter?  
How do you link characterization to mechanism of action?  
How can you ensure your data supports phase-appropriate regulatory expectations, without overstretching resources?

Attendees will also gain insight into technologies for EV engineering and production, as well as pre-defined characterization packages that can help you gain a head-start to proceed with confidence to IND/CTA. 

Attend this webinar to:

Understand the scientific rationale for early EV characterization and its impact on translational success 
Identify key quality attributes that influence safety, efficacy, and regulatory acceptance 
Understand the importance of early characterization to avoid common pitfalls in late-stage development

Davide Zocco

Senior Director, Commercial Development at Lonza

Davide Zocco, Senior Director, Commercial Development and Site Head of the Lonza site in Siena, Italy, leads R&D programs and process development services to support companies developing exosome-based therapeutics.

He was board member at his former company, Exosomics, a Lonza’s strategic R&D partner. He is an author of peer-reviewed publications in high profile journals which include Nature Chemical Biology, PNAS and American Journal of Pathology (>5000 citations), and of four patents in the extracellular vesicle field. He achieved a PhD from University College Dublin, Ireland and previously a post-doctoral research fellow at Harvard Medical School, USA.

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