Explore the Agenda

8:00 am Check in & Morning Coffee

8:50 am Chair’s Opening Remarks

Chief Executive Officer, Diadem Biotherapeutics

Demonstrating Safety & Efficacy Data to Prove the Potential of Exosome-Based Therapeutics in the Clinic & Drive Regulatory Approval

9:00 am Spotlighting the Clinical Application of Rion’s Platelet-Derived Exosome Therapeutic to Promote Tissue Repair & Improve Patient Outcomes

Senior Vice President, Research & Development, RION Health Inc.
  • Honing Rion’s platelet-derived exosome technology and application in regenerative medicine
  • Reviewing outcomes from ongoing clinical programs in advanced wound care and musculoskeletal diseases
  • Presenting additional, future applications of exosome-based technologies as a therapeutic platform

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9:30 am Session Reserved for Lonza

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10:00 am Highlighting Exosome-Driven Therapeutic Mechanisms of Deramiocel, an Allogeneic Cardiac-Derived Cell Therapy

Senior Vice President of Product Development, Quality Control & R&D, Capricor Therapeutics
  • Exploring recent update of deramiocel Phase 3 trial
  • Reviewing direct evidence deramiocel exosome homing to skeletal muscle
  • Understanding MOA of exosome on anti-fibrosis, anti-inflammatory and potential targeting mechanism

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10:30 am Morning Break & Speed Networking

This session is your opportunity to get face-to-face with many of the brightest minds working in the exosome and extracellular vesicle therapy field, and establish meaningful business relationships to pursue for the rest of the conference.

Harmonising Regulatory Frameworks Regarding Emerging Exosome Therapeutics to Enable Clinical Progress

11:30 am Beyond the Drug Model: Evidence-Based Dosing, Clinical Outcomes, and the Case for a New Regulatory Framework for Exosomes

Chief Executive Officer & Co-Founder, KweHealth
  • Evaluating exosome dosing strategies: concentrations, delivery methods, and clinical outcomes across multiple conditions
  • Understanding Why FDA drug approval models don’t fit acellular biologics — and how the ADDSB framework offers a risk-proportional alternative
  • Honing state-level exosome regulation trends and the legislative gap excluding acellular products despite their safety profile and signalling role

12:00 pm Bioprocess Design and Optimization of Extracellular Vesicles Derived From Mesenchymal Stromal Cells

  • Optimizing bioprocess design and orthogonal analytical strategies to achieve high-purity extracellular vesicle products
  • Enabling reproducible, scalable manufacturing while addressing batch-to-batch variation and quality control challenges
  • Advancing functionality and potency assays to support extracellular vesicle characterization and therapeutic development

12:30 pm Lunch

Improving Dosing Strategies & Clinical Trial Design to Efficiently Translate from Preclinical Studies to Clinical Trials

1:30 pm AGLE-102 Demonstrates Compelling Efficacy & Safety in a Phase 1/2a Study in Recessive Dystrophic Epidermolysis Bullosa

Chief Executive Officer, Aegle Therapeutics
  • AGLE-102 showed meaningful improvements in wound healing and skin integrity in patients with recessive dystrophic epidermolysis bullosa (RDEB), indicating strong therapeutic potential
  • The treatment was well tolerated across the study population, with no significant safety concerns or dose-limiting toxicities reported
  • Phase 1/2a results support further development, demonstrating both biological activity and clinical benefit in this high unmet-need genetic disorder

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2:00 pm When Will Big Pharma Join the EV Party?

Senior Vice President, Research & Development, RION Health Inc.
Medical Director, Liver Transplantation, Henry Ford Health System
Senior Principal, Regenerative Medicine, Dark Horse Consulting Group
Senior Director - International Business Development, Daicel Life Sciences

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2:30 pm Understanding the Cost Drivers of Clinical Trials to Optimise Design Manufacturing & Regulatory Pathways for Efficiency

Chief Executive Officer, Diadem Biotherapeutics
  • Breaking down major cost drivers including CMC development, GMP manufacturing scale-up, patient recruitment, and long-term safety monitoring requirements
  • Reducing inefficiencies through smarter trial design, including adaptive protocols, streamlined endpoints, and biomarker-informed patient selection
  • Leveraging scalable manufacturing and early regulatory alignment to minimise delays, rework, and costly late-stage development changes

2:30 pm Afternoon Networking Break

Strengthening Preclinical Translational of Exosome Therapeutics Through Predictive Models & Biodistribution Analysis to Improve Clinical Set Up

3:30 pm Building Robust Preclinical Development Pathways to Select Predictive Animal Models & Define Translational Endpoints

Founder & Chief Executive Officer, XOSOMIX, LLC
  • Selecting fit-for-purpose animal models that reflect disease relevance, biodistribution, and immunological response to exosome-based interventions
  • Establishing translational pharmacology frameworks linking dose, exposure, and functional response across in vitro and in vivo systems
  • Integrating safety pharmacology, toxicology, and biodistribution studies to de-risk first in-human clinical trial design

4:00 pm Monitoring Biodistribution of Exosome Therapeutics to Advance Quantitative Tracking Validation Strategies & Improve Translational Interpretation

Research & Development Director, Neucore Bio
  • Implementing robust labelling and detection strategies (e.g., fluorescent, radioactive, or molecular tagging) to enable accurate in vivo tracking of exosome fate
  • Addressing methodological challenges including signal dilution, label stability, and distinguishing free label from intact vesicles
  • Correlating biodistribution profiles with pharmacodynamic effects to inform dosing, safety assessment, and tissue targeting strategies

4:30 pm Chair’s Closing Remarks

Chief Executive Officer, Diadem Biotherapeutics

4:40 pm Scientific Poster Session

Present a poster to showcase your latest research and ensure your work is directing the conversation. This is your chance to exchange ideas, explore fresh perspectives, and dive into cutting-edge data with fellow authors and attendees.

5:40 pm End of Conference Day One