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 

Speakers: