Hebe Sun
Associate Director, CDx/IVD Regulatory Affairs Regeneron Pharmaceuticals
Hebe Sun, Regulatory Affairs Associate Director in Regeneron, contributed to the CDx/IVD co-development in multiple gene therapy programs in Regeneron. Before Regeneron, she has multiple years of regulatory experience in medical device and IVD industry.
Seminars
Wednesday 25th March 2026
Anticipating Diagnostic Demands to Avoid Costly Delays in Gene Therapy Development
4:15 pm
- 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
