From Protocol to Patient: Designing Companion Diagnostics Programs That Reach Market Faster

• 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

Speakers:

Christine Federovitch

Head, Regulatory Affairs, IVD

Navigate BioPharma