Building a Regulatory-Ready Preclinical Package in Dry AMD: Understanding the Evidence, Tools, and Models Required to De-Risk Early Development
Time: 9:00 am
day: Day2
Details:
- Analyze lessons from recent approvals and rejections
- Outline preclinical evidence requirements that regulators expect to see
- Review the role of translational assays, imaging, and endpoints to de-risk translation
- How to align animal models with clinical endpoints to support IND submission
