Navigating Complexity: Addressing Challenges with Naive Exosomes
Time: 11:00 am
day: Day One Track B AM
Details:
• 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
