Christine Federovitch
Head, Regulatory Affairs, IVD Navigate BioPharma
Seminars
Thursday 8th October 2026
From Protocol to Patient: Designing Companion Diagnostics Programs That Reach Market Faster
11:50 am
- Explore how early assay assumptions can become patient-selection decision rules before the evidence supports them
- Discuss how clinical studies can be designed to generate meaningful assay insight, including threshold rationale and intended-use alignment
- Review how IVDR performance study requirements impact rare disease trial design, site activation, change management, and adverse event reporting
- Understand why global CDx strategy must account for regional evidence expectations early, including China-specific performance testing requirements
