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Exosomes Europe
3-5 November 2025
Amsterdam Marriott HotelAmsterdam, Netherlands
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Pre-Conference Workshop (3/11/25) - Amsterdam CET

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Pre-Conference Workshop (3/11/25) - Amsterdam CET
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08:30 - 09:00
Registration & Coffee
Showing 1 of 1 Streams
09:00 - 09:15Workshop
Welcome - Beyond Discovery: Navigating the ‘Valley of Death’
  • Welcome, Introductions, Workshop Objectives
  • Overview: the ‘Valley of Death’ in commercialisation
09:15 - 10:30Workshop
From Discovery to Defensible Concept: Building the Foundation
  • From Phenomenon to Product
    • Elucidating the Mechanism of Action (MoA) and identifying the key therapeutic components of your EVs.
  • Generating a Robust Pre-clinical Data Package
    • What in vitro and in vivo data are essential to demonstrate proof-of-concept and therapeutic potential?
  • Defining a Technical Basis
    • Moving beyond composition-of-matter to protect manufacturing processes, engineered elements, and use-cases.
10:30 - 11:00Workshop
Morning Break
11:00 - 12:00Workshop
The Scientific Data Package for Investment
  • The Investor's Technical Due Diligence
    • Presenting compelling MoA and in vivo data.
  • Quantifying Your Innovation
    • Developing assays and metrics for your product.
  • Translating Scientific Milestones into Value Inflection Points
    • How to structure your R&D plan to align with fundraising rounds.
12:00 - 13:00Workshop
Networking Lunch
13:00 - 14:15Workshop
Process Development & CMC: From Lab-Scale to Clinical-Grade EVs
  • Fundamentals of CMC for Exosomes
    • Introduction to Chemistry, Manufacturing, and Controls for a complex biologic product.
  • Defining Your Product: Critical Quality Attributes (CQAs)
    • Identifying and justifying the key physical, chemical, and biological attributes that define your EV product's identity and function.
  • Developing Robust Potency Assays
    • Moving beyond characterization to create a functional assay that predicts clinical efficacy.
  • A Critical Analysis of Purification Platforms
    • Technical considerations for choosing between purification technologies, and other methods for your specific product and scale.
14:15 - 14:45Workshop
Afternoon Break
14:45 - 16:00Workshop
The Path to IND: Key Pre-clinical & Early Clinical Requirements
  • Designing the Pre-clinical Safety Package
    • Essential toxicology, biodistribution, and stability studies required by regulatory agencies.
  • Dose-Finding Strategies for Complex Biologics
    • Scientific approaches to translating pre-clinical efficacy data into a safe and logical first-in-human dosing plan.
  • Selecting Relevant Biomarkers for Phase 1 Trials
    • How to choose pharmacodynamic or exploratory biomarkers to demonstrate your EV therapy is having a biological effect.
16:00 - 16:30Workshop
Workshop Wrap-Up & Discussion
16:30 - 16:35
End of Pre-Conference Workshop
NextMain Conference Day 1 (4/11/25)
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