Regulatory Pathways and Clinical Trials: Advancing Exosome Therapeutics from Lab to Clinic
Time: 9:30 am
day: Day Two
Details:
• 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
