CONFERENCE DAY TWO
8:00 am Check-In & Morning Coffee
8:50 am Chair’s Opening Remarks
Bridging the Clinical & Regulatory Gap for the Safe & Efficacious Development of Exosome-Based Therapeutics
9:00 am EVerGel for Crohn Perianal Fistula: Exosomes Embedded in Hydrogel
Synopsis
- Showcasing preclinical data in perianal fistula
- Highlighting quality control and regulatory challenges of a formulation with a hydrogel
- Outlining the regulatory preparation of a phase 1b/2a clinical trial in Crohn fistula
NEW DATA!
9:30 am Roundtable Discussion: Harmonizing the Exosome & Extra-Cellular Vesicle Regulatory Landscape Towards Better Definitions, Practices & Guidelines for Therapeutic Success
Synopsis
- What are the current gaps in knowledge of submissions, and what can we learn from current therapeutic progress in the clinic?
- How does the current regulatory guidance provide clarity on CMC changes for exosome-based therapeutics?
- How can the exosome biopharma industry and regulators continue to support each other to ensure global harmony and better therapeutics to patients faster?
10:00 am Morning Break & Networking
Unlocking Exosome Therapeutics Manufacturing: Strategies for Stability, Scalability & Efficiency
10:30 am Advancing Exosome-Based Therapies: From Bench to Bedside
Synopsis
- Overcoming current manufacturing challenges
- Innovating novel delivery mechanisms for enhanced efficacy
- Showcasing clinical trial data and future directions
NEW DATA!
11:00 am Advancing the Effective Production & Scale-Up of Exosomes Towards GMP-Grade Compliance
Synopsis
- How to effectively scale exosomes for GMP-grade manufacturing from research to clinical
- Exploring strategies for minimizing batch-to-batch variations by optimizing sourcing processes, culture conditions, and ensuring uniformity in starting materials for efficient scale-up
- Ensuring quality EV isolation from a purified population of the right cell types and consistent supply using scalable processes
NEW DATA!
11:30 am Panel Discussion: Accelerating Scalable & Cost-Effective Extra-Cellular Vesicle Manufacturing for the Development of Therapeutics for Regenerative, Precision & CGT Therapies
Synopsis
- Exploring cost-efficient exosome sources such as bodily fluids to reduce the high production costs associated with cellderived exosomes
- Understanding the complexities involved in setting up pipelines for the purification and production of engineered exosomes to optimize cost considerations throughout the development process
- Delving into the factors contributing to the cost of engineered exosomes, including production methods and regulatory compliance, for strategic planning to manage expenses effectively
12:00 pm Lunch Break & Networking
Building an Investable Exosome Therapeutic Platform from Discovery R&D Towards Market Readiness
1:00 pm Roundtable Discussion: into Market Conditions for Exosome/EV Therapy Development
Synopsis
- Understanding how market conditions can influence investor interest and funding availability for exosome and EV therapy development
- Demonstrating clinical promise and addressing regulatory hurdles to mitigate investor concerns and maintain confidence in exosome and EV-based therapies
- Exploring the potential for new innovations in exosome and EV development to attract investment in exosome therapy development
1:30 pm Strategic Development of a Native Extracellular Vesicle Platform Technology for Regenerative Medicine Therapeutic Applications
Synopsis
- EV Therapeutics has broadened our portfolio to include a novel, native EV technology, synergistic with our modified EV therapeutic platform
- This platform technology has strong MOA data and is supported by positive clinical use data outside the USA
- Prioritizing this native EV technology enables EV Therapeutics to chart a more rapid path towards clinical trials and US regulatory approval
NEW DATA!
2:00 pm Quantitative Protein Profiling of Extracellular Vesicles as a Platform for Therapeutics
Synopsis
- AI-based Quantitative protein profiling of extracellular vesicles is a powerful platform that can revolutionize therapeutics and the efficacy of treatment
- Using EVs to develop a non-invasive diagnostic biomarker of endometriosis
- Development of EV-based therapy for Alzheimer’s disease
NEW COMPANY!
2:30 pm Afternoon Break & Networking
Innovating Exosome-Based Therapeutics to Tackle Oncology Indications Success
3:00 pm Up in ARMMs – A Novel Delivery System for Multiple Payloads
Synopsis
- What are ARMMs
- Gene Editing for Stargardt Disease
- Other potential clinical uses for ARMMs
NEW DATA!
3:30 pm Exosome-Displayed Fusion Proteins Unlock TNF Receptor Superfamily Agonism for Cancer Immunotherapy
Synopsis
- Overcoming the challenge of TNFRSF agonism: limitations of traditional protein biologics
- Engineering multivalent exosome display using a novel type II transmembrane anchor
- Demonstrating superior agonist activity: In vitro and in vivo validation
NEW COMPANY!
4:00 pm Showcasing Natural Killer (NK) Cell Derived EVs as a New Treatment for Patients with Relapsed/Refractory Cancers
Synopsis
- Demonstrating NK EVs’ strong and broad anti-tumor activity without harming healthy cells
- Developing a new off-the-shelf biological product widely available to treat cancer patients who fail current treatments
- Identifying a quantitative biomarker of NK EV activity
NEW COMPANY!