Exploring a Case Study With Agency Interactions to Hone the Process & Confidently Enter Conversations with Regulatory Agencies

• Lessons from early regulatory interactions across multiple agencies highlighting evolving expectations for exosome classification
• Case study approaches to resolving questions on characterization, assay development, and comparability in a heterogeneous biological product
• Building an aligned global development plan by integrating feedback from regulatory consultations into clinical design

Speakers:

Wanjun Chen

Senior Investigator

NIH