So-ching Brazer

Company: Adicet Bio

Job title: Executive Director - Regulatory & CMC

Seminars:

Navigating Global Comparability Expectations in Cell & Gene Therapy CMC Development 1:30 pm

Harmonizing comparability approaches: contrasting FDA, EMA, and agencies such as Health Canada, ANVISA (Brazil), and CDE (China) to understand their impact on CMC strategy Risk-based frameworks for comparability assessment: leveraging analytical tools, potency assays, and totality-of-evidence to manage complex modality changes Proactive regulatory engagement: best practices for early discussions, submission planning, and addressing post-approval manufacturing…Read more

day: Conference Day Two