Exosome Website - Headers (12)

* All times shown in EST

8:00 am Morning Speed Networking

Synopsis

Grab a coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

8:50 am Chair’s Opening Remarks

ENGINEERING CONSISTENT & EFFECTIVE EXOSOME BASED THERAPEUTICS

9:00 am Neural Exosomes as a Targeted Therapeutic & Drug Delivery System

  • Steven Stice Co-Founder & Chief Scientific Officer & Professor, ArunA Bio

Synopsis

  • Discuss how neural stem cell derived exosomes have tropism for areas of the central nervous system associated with motor and cognitive function
  • Discover how neural exosomes loaded with siRNA delivered to the central nervous system
  • Understand how neural stem cell derived exosomes have antiinflammatory activity and neural/neurovascular protective and repair
    properties

9:30 am Producing EVs at the Clinical Scale

Synopsis

  • When the product is the process, learn how to scale processes are commercially essential, even for early clinical trials
  • Hear about how Exopharm’s experiences with Human Clinical Trials of platelet EVs are shaping our approach to MSC-EVs and engineered EVs

10:00 am Extracellular Vesicles: A Trojan Horse for Delivery of Therapeutic Gene Editing Modalities

  • Koen Breyne Post-Doctoral Researcher, Massachusetts General Hospital, Harvard Medical School

Synopsis

  • Exogenous loading of EVs in physiological conditions
  • Overcoming detection of transient EV cargo delivery

10:30 am Virtual Speed Networking

Synopsis

Grab a coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

11:00 am Hybridosomes, an Exosome-Based Platform for Targeted, Re- Dosable & Durable Gene Therapies

Synopsis

  • Uncover engineered exosomes for the efficient delivery of novel capsidfree viral vectors for next generation gene therapies
  • Learn pivotal benchmarking experiments that outline optimized nucleic acid delivery by targeted Hybridosomes vis-a-vis to state-of-the-art LNP formulations
  • Know valuable insights into scalable production and isolation methods

11:30 am Applying an In Silico Platform to Engineer EVs as Delivery Vehicles

  • Alex Mok Co-Founder & Chief Executive Officer, Mantra Bio

Synopsis

  • A dry lab-to-wet lab approach to expedite EV therapeutic drug development and discovery
  • Robust exosome protein engineering platform to generate a library of unique EV delivery vehicles

12:00 pm A Unique Strategy to Load Therapeutic Proteins into Exosomes

  • Chulhee Choi Chief Executive Officer, ILIAS Biologics Inc.

Synopsis

  • Introduction of EXPLOR technology: exosome engineering for protein loading via optically reversible protein-protein interaction
  • Examine the therapeutic effects of the exosomes loaded with antiinflammatory protein

12:30 pm Breakout Group Discussions: Preparing Scalable Manufacturing Processes for Clinical Trials & Beyond

Join a dedicated discussion group for this deep-dive session into your chosen topic. Discuss, share and debate in small breakout groups to find actionable takeaways and establish improved manufacturing processes in your own work.

How are we ensuring GMP/GLP early to streamline the transition to larger-scale production?

What methods are successful in scaling exosomes? Is there any way we can improve these?

What regulatory considerations have come to light to inform trial designs? How can we use these to optimize preclinical trials and manufacturing methods?

Evaluating the technologies & tests available for engineering exosomes

1:30 pm Virtual Speed Networking

Synopsis

Grab a coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

ADVANCING EXOSOME THERAPEUTICS TO THE CLINIC

2:00 pm Tactically Preparing for Clinical Progression

Synopsis

  • Staying focussed: Gaining funding, aligning partnerships and more to progress quickly and efficiently to have clinical trials in reach
  • Working with the FDA to achieve IND status
  • Setting the company up for success: what were the key focus points to streamline clinical transition?

2:30 pm “Good Things Come In Small Packages”: Application of Exosome- Based Therapeutics in Neonatal Cardio-Respiratory Disease

  • Gareth Willis Instructor, Pediatrics, Boston Children’s Hospital, Harvard Medical School

Synopsis

  • Look into preclinical development of mesenchymal stromal cell derivedextracellular vesicles in models of experimental neonatal lung injury
  • Toward exosome-based therapeutics: isolation, heterogeneity, MoA, biodistribution and fit-for-purpose potency

3:00 pm Clinical Potential of Unmodified Mesenchymal Stromal Cell- Derived EV Therapeutics

  • Eva Rohde Head, Department of Transfusion Medicine & Director, GMP Unit University Hospital & Paracelsus Medical University, Salzburg

Synopsis

  • Unravel how MSC-EVs may serve as potent anti-inflammatory, antiscarring and neuroprotective agents in various diseases
  • The transition from EV research into clinical scale EV generation under good manufacturing practice is one of the bottlenecks for translational approaches and clinical development, not only in the EV field
  • Another bottleneck is a sufficient characterization of EV therapeutics before clinical testing
  • Gain insight into the developmental steps ranging from discovery until first clinical experiences with umbilical cord-derived MSC-EVs

3:30 pm Virtual Speed Networking

Synopsis

Grab a coffee from the comfort of your own kitchen and jump into this 1:1 networking session to make new connections, exchange virtual business cards and maybe even see a friendly face or two!

4:00 pm Panel Discussion: Advancing Exosome Therapeutics to the Clinic

  • Gareth Willis Instructor, Pediatrics, Boston Children’s Hospital, Harvard Medical School
  • Steven Stice Co-Founder & Chief Scientific Officer & Professor, ArunA Bio
  • Shelley Hartman Chief Executive Officer, Aegle Therapeutics

Synopsis

  • Lessons in transitioning to the clinic: What have we learned from the first few trials starting?
  • Understanding the impact of partnerships on clinical trials and how to strategize your investments
  • How can we work with patients to improve trial engagement and maximize enrolment for this novel therapeutic approach?

5:00 pm Chair’s Closing Remarks & End of Day One