Betsy Rezner

Company: Fate Therapeutics

Job title: Executive Director - Quality Control & Analytical Development

Seminars:

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 endpointsRead more

day: Day 1 - Track A - Afternoon

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…Read more

day: Day 2 - Track B - Morning