Betsy Rezner
Seminars
Wednesday 3rd December 2025
Panel Discussion: Balancing Risk & Benefit When Making Late-Stage Analytical Changes
12:00 pm
- How to assess the scientific, regulatory, and operational risks of modifying assays or specifications after pivotal trials begin
- When is it worth changing a method late-stage and what data is needed to justify the decision to regulators and internal teams?
- Best practices for building a comparability and bridging strategy that supports product integrity without delaying timelines
Tuesday 2nd December 2025
Navigating Genomic & Functional Characterization in Gene-Edited Cell Therapies
1:40 pm
- Examine assay strategies to confirm both the presence of edits and preservation of cell function post-engineering
- Review real-world approaches for correlating genomic modifications with therapeutic impact using robust analytical endpoints
