Anticipating Diagnostic Demands to Avoid Costly Delays in Gene Therapy Development

• Clarifying the evolving FDA expectations for companion diagnostics in gene therapy programs
• Identifying strategies to mitigate delays caused by late-stage CDx requirements
• Understanding how regulatory ambiguity impacts patient selection and program timelines

Speakers:

Hebe Sun

Associate Director, CDx/IVD Regulatory Affairs

Regeneron Pharmaceuticals