* All times shown in GMT

8:00 am
Registration & Morning coffee

8:50 am Chair’s Opening Remarks

Keynote Plenary Session: Evaluating the EV Landscape to Fast-Track Clinical Proof of Concept & Accelerate the Route to Market

9:00 am An Introduction to The Science of Regenerative Medicine

  • Ian White Chief Executive & Scientific Officer, The American College of Regenerative Medicine

Synopsis

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9:30 am Showcasing Key Clinical Updates of Exosome Based Therapeutics

  • George Shapiro Chief Medical Innovation Officer, OrganiCell Regenerative Medicine

Synopsis

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10:00 am Expanding Therapeutic Potential of SIRP-INV to Acute Organ Failures

  • Gi-Hoon Nam Co-Founder & Chief Executive Officer
    Assistant Professor
    , ShiftBio Inc.
    Korea University College of Medicine

Synopsis

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10:30 am Extracellular Vesicles: Accelerated Path From Benchtop to IND & Beyond

  • Marcos Langtry Director- Commercial Development & Allogeneic Cell Therapy, Lonza
  • Davide Zocco Head of Exosomes Development & Site, Lonza

Synopsis

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11:00 am
Morning Break & Speed Networking

Track A:

Discovery & Pre-Clinical Track

Determining the Mechanisms of Action to Improve Targeting In Vitro& in Vivo to Define Functional Effect

Synopsis

Chair: Subree Subramanian, Chief Scientific Officer, EV Therapeutics

12:00 pm Beneficial Effects of Small Extracellular Vesicles From MSC-NTF Cells In Multiple Lung Injury Models

Synopsis

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12:30 pm Nano-flow cytometry for comprehensive EV subpopulation analysis

Synopsis

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12:45 pm Charting a Pre-Clinical Path to Defined Functional Application

Synopsis

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Track B:

Clinial Development & Manufacturing Track

Exploring Strategies for Successful Cargo Loading to Optimize Therapeutic Potential

12:00 pm Engineered Exosome Platform for Therapeutic Development

  • Linda Marban Chief Executive Officer, Capricor Therapeutics

Synopsis

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12:30 pm Approaches for Scalable Purification & Analytical Characterization for cGMP Manufacture of Exosomes

Synopsis

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12:45 pm Extracellular Vesicles-Based Therapy for Spinal Cord Injury

Synopsis

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1:15 pm
Networking Lunch Break

Assessing Therapeutic Effect of Exosomes from Different Sources for Optimized Targeting

2:15 pm Milk Derived EVs as a Novel, Injury-Targeting Therapeutic Platform

Synopsis

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2:45 pm The Basic & Applied Biology of Extracellular Vesicles (EV)/Exosomes

  • Raghu Kalluri Professor- Cancer Biology, MD Anderson Cancer Centre

Synopsis

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Assessing Approaches to IND Filing & Optimizing Analytical Methods for Clinical Success

2:15 pm Therapeutic Neural Exosomes for Acute & Chronic Neurological Conditions

Synopsis

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2:45 pm Therapeutic Advances of Stem Cells-Derived Extracellular Vesicles in Osteoarthritis

Synopsis

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3:15 pm
Afternoon Networking Break & Refreshments

Navigating the Challenging Regulatory Landscape when Exosomes are a Novel Technology with No Set Guidelines

3:45 pm Panel Discussion: Understanding & Implementing Regulatory Requirements Across the Drug Development Timeline

  • Heidi Kempinski Chief Operating Officer, Aegle Therapeutics
  • Ian White Chief Executive & Scientific Officer, The American College of Regenerative Medicine
  • Craig Newton Director, VivaZome Therapeutics

Synopsis

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4:45 pm Key CMC Considerations for EV based Therapeutic Regulatory Compliance

Synopsis

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5:15 pm
Chair’s Closing Remarks & End of Conference Day One

5:30 pm
Drinks Reception