8:00 am Morning Coffee & Registration
8:45 am Chair’s Opening Remarks
Regulatory Pathways & Clinical Trials: Advancing Exosome Therapeutics from Lab to Clinic
9:00 am Regulatory Pathways and Clinical Trials: Advancing Exosome Therapeutics from Lab to Clinic
Synopsis
• Defining the Roadmap: Exploring the development of standardized analytical protocols necessary for FDA scrutiny of exosome biologics focusing on safety, purity, potency, identity, and effectiveness
• Addressing the absence of standardized testing in the nascent field of exosome therapeutics, drawing parallels with the early days of cell and gene therapy
• Advancing Regulatory Understanding: Demonstrating how establishing robust analytics can aid regulatory bodies in assessing the mechanisms and safety of exosome products, propelling the field towards clinical adoption
9:30 am Session Reserved For NanoFCM
9:45 am Navigating Clinical Trials for Exosome-Based Therapeutics: From Phase I to Approval
Synopsis
• Reviewing the progression of exosome therapeutics from initial trials to market approval
• Focusing on patient selection and regulatory navigation to enhance trial design and improve early-stage success rates
• Utilizing strategic partnerships to accelerate development timelines
10:15 am Morning Networking Break
Preclinical Development
11:15 am Exosomes as Biomarkers: A New Frontier in Medical Diagnostics
Synopsis
• Understanding the biogenesis of exosomes and their role in intercellular communication, establishing the foundational knowledge necessary for leveraging exosomes in disease diagnosis and monitoring
• Exploring the latest techniques in isolating and analysing exosomes, highlighting their potential as reliable biomarkers for early disease detection, prognosis, and therapeutic efficacy assessment
• Examining case studies where exosomes have been successfully used as biomarkers in various diseases, including cancer, neurodegenerative diseases, and cardiovascular conditions
11:45 am Exosomal CRISPR-Cas9 Delivery: A New Era in Gene Therapy
Synopsis
• Exploring cutting-edge methods for loading CRISPR-Cas9 into exosomes for precise gene editing. Detailing exosome isolation, loading, and targeting capabilities for enhanced gene correction
• Presenting detailed analyses of ongoing and completed trials using exosome-delivered CRISPR-Cas9 for genetic diseases. Highlighting trial phases, and preliminary outcomes
• Discussing the complexities of scaling exosome-based CRISPR delivery systems, including maintaining cargo integrity, delivery precision, and immune evasion
Clinical Development & Manufacturing
11:15 am Developing an Engineered Exosome Platform for Therapeutic Development
Synopsis
• Exploring StealthX, a precise exosome-based drug delivery platform, promising targeted and effective treatment strategies
• Focusing on optimizing exosome targeting to improve delivery and efficacy, enhancing patient care
• Delving into the potential for clinical success with engineered exosomes, aiming to revolutionize personalized medicine
11:45 am Assessing Extracellular Vesicles for Membrane-Associated Protein Delivery
Synopsis
• Utilizing Theraxcyte’s TAXYTM System: Explore how this platform enhances the delivery and functionality of
membrane-associated therapeutic proteins using extracellular vesicles
• Discuss challenges such as maintaining membrane protein stability and optimizing delivery, with innovative approaches ExpBoostTM and ExoDisplayTM to boost exosome yield
• Review case studies demonstrating the effective application of EVs in clinical settings, highlighting improved targeting and therapeutic outcomes
12:15 pm Networking Lunch
1:15 pm Extracellular Vesicle-Mediated Communication in the Tumor Microenvironment
Synopsis
• Investigating the role of extracellular vesicles (EV)-mediated microRNA transfer from tumor cells to other cells in the tumor microenvironment, including tumor-associated macrophages
(TAM)
• Delving into microRNA-based TAM reprogramming from protumoral (M2) to anti-tumoral (M1) phenotype
• Exploring non-viral delivery of microRNA mimics and EVmediated bystander effects.
1:45 pm Challenges in Regenerative Medicine: Navigating the Complexities of Exosome-Based Therapeutics
Synopsis
• Refining methods to direct exosomes precisely to damaged tissues or specific cell types, improving therapeutic efficacy
• Developing strategies to protect exosomes from degradation and ensure effective delivery to the target site
• Understanding and complying with the evolving regulatory landscape for exosome-based therapies, from preclinical research to clinical application
2:15 pm RNA-Loaded Exosomes: Silencing Disease Pathways
Synopsis
• Delving into encapsulating siRNA within exosomes for targeted gene silencing, focusing on specificity and efficiency in delivering siRNA to relevant cells
• Detailing the advancement of clinical trials using exosomeencapsulated siRNA for conditions, sharing insights into dosage optimization, delivery methods, and therapeutic outcomes
• Analyzing challenges in ensuring the stability and targeted delivery of siRNA-loaded exosomes to enhance cellular uptake and navigate the immune system
1:15 pm Protein Therapeutics in Exosomes: Clinical Update & Future Directions
Synopsis
• Providing insight on the latest advancements in exosome based protein therapeutics, including breakthroughs in clinical trials and patient outcomes
• Discussing the challenges and strategies in designing protein loaded exosomes for targeted therapy, with a focus on enhancing delivery efficiency and therapeutic impact
• Exploring the potential of protein therapeutics within exosomes to revolutionize treatment across various diseases, highlighting future research directions and the roadmap to clinical application
1:45 pm Novel Approaches & Promising Futures: Topical Exosomes
Synopsis
• Exploring cutting-edge developments in the use of topical exosomes for skin, highlighting their mechanisms of action and therapeutic potential in skincare
• Examining advancements in the formulation and stabilization of topical exosome products, focusing on improving delivery efficiency and patient outcomes
• Discussing the promising future of exosomal therapies, considering potential applications in anti-aging treatments
2:15 pm Session reserved for ZeoScientific
2:45 pm Afternoon Networking Break
Exosome Innovation: Pioneering Therapeutic Applications & Enhanced Delivery Solutions
3:45 pm Roundtable: Bridging Cell & Gene Therapy: The Dual Potential of Loaded Extracellular Vesicles
Synopsis
• Highlighting the inherent therapeutic properties of EVs that align them closely with cell therapy approaches, presenting a unique opportunity for natural and effective treatment modalities
• Investigating the capability of EVs to encapsulate and transport genetic material, facilitating targeted gene delivery with high specificity
• Discussing the integration of cell and gene therapy strategies using loaded EVs, leveraging their dual capabilities to enhance therapeutic precision and outcomes
4:30 pm Inhale to Heal: Delivering Dried Exosomes Powders to the Lung
Synopsis
• Exploring a novel anti-fibrotic, anti-inflammation exosome derived from healthy donor lungs to enable local regeneration of lung tissue
• Delving into nebulized or DPI delivery of LSC-EXO to the lung to demonstrate efficacy against acute and chronic lung diseases
• Demonstrating improved stability of exosomes by reducing to solid