Jiri Aubrecht

Company: Prothena

Job title: Vice President & Head of Clinical Biomarkers

Seminars:

1:00 Outlining the Regulatory Roadmap for Efficient Official Validation of Biomarkers 1:00 pm

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…Read more

day: Conference Day 2