Global Regulatory Guidelines & Biomarker Qualification: How is the Regulatory Landscape Evolving?
Time: 11:00 am
day: Day 1 Stream 2 AM
- How set in stone are endpoints and what is needed to validate surrogate endpoints?
- Establishing a clinical pathway to correlate non-invasive biomarkers with clinical outcomes and considering what is required to demonstrate efficacy in combination therapy
- Harmonizing global regulations in the context of distinct regulatory expectations and exploring precision medicine in NASH