7:30 am Morning Check In
8:15 am Chair’s Opening Remarks
Elevating Exosome Research: Characterization Standardization & Advanced Purification Techniques
8:30 am Engineering and Isolation of EVs: From Primary Cell Engineering Platform Technology to EV Isolation
Synopsis
• Introducing the ESM (Extracellular Vesicle Sorting Motif) platform technology for engineering primary cell lines
• Highlighting the importance of developing efficient purification processes for the development of EV-based therapeutics
• Exploring the therapeutic efficacy of primary cell engineered EVs
9:00 am Session Reserved for Lonza
9:30 am Assessing Light-Reversible Microswimmer Particles to Enable High-Purity & Low-Cost Isolation of Extracellular Vesicles from Biofluids
Synopsis
• Presenting the innovative design of the Janus Microswimmer for high-efficiency and easy-to-operate isolation of EVs from various biofluids, highlighting advantages in simplicity, yield, and purity against conventional isolation methods
• Highlighting the clinical implications of using this technology for EV-based diagnostics and therapeutics
• Discuss potential future developments and applications of this technology in clinical settings, emphasizing the broader impact on personalized medicine
10:00 am Morning Break & Speed Networking
Preclinical Development
11:00 am Changing the Medical Paradigm: Use of Extracellular Vesicles as a Multimodal Biological Approach in Therapeutics
Synopsis
• Assessing major steps towards the development of a naive EV product derived from umbilical cord blood
• Summarizing safety and efficacy data in pre-clinical models accross multiple indications
• Delving into future perspectives for a multimodal EV-based therapy
11:30 am Enhancing Delivery: Innovative Approaches to Exosome Loading for Pre-Clinical Studies
Synopsis
• Investigating novel methods for loading therapeutic molecules into exosomes to maximize their potential as targeted delivery vehicles in pre-clinical models
• Assessing the efficiency and retention of different loading techniques, including electroporation and sonication, to optimize delivery of RNA, proteins, and drugs
• Exploring the implications of loading efficacy on the stability and bio-distribution of exosomes in pre-clinical studies, aiming to improve therapeutic outcomes
Clinical Development & Manufacturing
11:00 am Navigating Complexity: Addressing Challenges with Naive Exosomes
Synopsis
• Evaluating the reproducibility challenges associated with naive exosomes, including the consistency of cargo from
donor materials and assessing the therapeutic efficacy based on protein and RNA loads
• Examining the difficulties in pinpointing the mechanism of action and explaining the therapeutic benefits to regulatory bodies like the FDA
• Discussing the trade-offs between safety and variability in naive exosome products, highlighting the ease of release criteria versus the challenges in answering specific questions about functionality and efficacy
11:30 am From R&D to GMP Exosomes Mass Production for Ongoing Clinical Phase I/II & Inflammation Related Indications
Synopsis
• Key elements to take into account during R&D and preclinical not lose years and funds in GMP transition process
• How to produce enough exosomes in a GMP compliant way to answer clinical trial demand
• What does the regulatory pathway looks like in Europe to start phase I/II
12:00 pm Networking Lunch
1:00 pm Optimizing Targeted Cargo Delivery with Exosomes
Synopsis
• Examining innovative approaches for loading exosomes with therapeutic cargo while maintaining stability and efficacy
• Discussing strategies to enhance exosome uptake by target cells through surface modifications and receptor-ligand interactions
• Exploring the challenges and opportunities of engineering exosomes for specific tissue targeting and intracellular delivery mechanisms
1:30 pm Precision Isolation Techniques in Exosome Research
Synopsis
• Detailing advanced methods for the isolation of exosomes, such as ultracentrifugation and size-exclusion chromatography, to ensure purity and specificity
• Evaluating the effectiveness of isolation techniques in preserving the functional integrity and biological activity of exosomes for accurate outcomes
• Discussing the standardization of isolation protocols to facilitate reproducibility and comparability of exosome research across different pre-clinical and clinical settings
2:00 pm Advancing Exosome Research with Animal Models
Synopsis
• Examining criteria for choosing animal models that align with human disease mechanisms, highlighting bone disease
• Discussing advancements in animal model development, including genetically engineered mice
• Case study: Exosomes or exosome biomimetics as novel treatment for osteoporosis and bone cancer: Discovery, animal studies, problems, future directions
1:00 pm Overcoming Scale-Up Challenges for Naive Exosomes
Synopsis
• Discussing advancements in the production of engineered exosomes, from bioreactor design to purification techniques
• Highlighting the importance of quality control measures and regulatory compliance in the manufacturing process to ensure the consistency and safety of exosome batches
• Gaining insight into transitioning engineered exosomes from laboratory-scale production to preclinical trial quantities, including case examples of overcoming scale-up obstacles
1:30 pm Choosing Exosome Related Investigational Products That Show Potential For Clinical Indications
Synopsis
• Examining how to identify exosome products loaded with therapeutic cargos, focusing on proof-of-concept testing methods that demonstrate potential for clinical success
• Learning from accumulated industry experiences in standardizing the manufacturing of human exosomes to ensure quality and compliance as products move towards clinical trials
• Discussing the strategies and critical considerations needed to transition exosome-based therapeutics from development into Phase I and II clinical studies
2:00 pm Exosome Innovations in Cosmetics: Pioneering the Future of Skincare
Synopsis
• Delving into exosome’s role in revolutionizing skincare, offering solutions for skin regeneration, anti-aging, and delivering powerful skincare benefits
• Exploring the development of cutting-edge exosome-based cosmetics designed to precisely target and rejuvenate skin cells, offering enhanced protection and repair from environmental damage
• Discussing strategies for successfully navigating the complex regulatory landscape to bring cosmeceutical products to consumers, and meet the highest standards of safety and efficacy
2:30 pm Afternoon Networking Break & Poster Session
Strategic Optimization of Production Methods for Commercial & Manufacturing Efficiencies
3:30 pm Panel Discussion: Strategic Efficiencies in Development & Production: Cost-Optimization, Compliance, & Storage Solutions
Synopsis
• Streamlining the path to commercialization, to navigate the journey from development to market readiness with efficiency
• Exploring strategies to significantly reduce costs of goods sold of Advanced Therapy Medicinal Products (ATMPs), enhancing affordability and accessibility
• Delving into characterization of product and process related impurities to uphold product quality standards
4:15 pm Challenges & Opportunities in Manufacturing of EV-based Therapeutics
Synopsis
• Providing an overview of the current landscape in manufacturing EV-based therapeutics at scale, identifying key challenges and opportunities for innovation
• Highlighting case studies showcasing process improvements in EV production from cell culture, leading to enhanced productivity and efficiency
• Discussing emerging trends and techniques in EV manufacturing, emphasizing their potential to shape the future of therapeutic development and application
4:45 pm Optimizing Costs for Enhanced Development of Naive Exosomes
Synopsis
• Exploring cost-efficient alternatives, such as utilizing bodily fluids like milk or platelets, to reduce the high production costs associated with cell-derived exosomes
• Understanding the complexities involved in setting up pipelines for purification and production of naive exosomes to optimize cost considerations throughout the development process
• Delving into the factors contributing to the cost of naive exosomes, including production methods and regulatory compliance, for in strategic planning to manage expenses effectively