1:00 Outlining the Regulatory Roadmap for Efficient Official Validation of Biomarkers
Time: 1:00 pm
day: Conference Day 2
Details:
- Presenting the necessary steps for different pathways of biomarker approval, minimal requirements, metrics and best practice
- Appropriately validating assays from an analytical, clinical and regulatory standpoint for with the correct context of use
- Outlining a strategic approach to IND filings by aligning timing, data readiness, and regulatory requirements
- Knowing when and how to push for approval based on the strength of supporting biomarker data