Unpicking the Details of the New FDA Guidance: “Potency Assurance for Cellular & Gene Therapy Products” – Changes, Learnings & Implications

Time: 1:05 pm
day: Pre-conf day - Stream B


This workshop aims to dissect the recently released FDA guidance on potency assurance for cellular and gene therapy products, analyze the alterations, extract key learnings, and discuss the broader implications for assay development in the field of gene therapy.

Attend to Discuss:

  • Outlining the major changes made to the new FDA guidance to understand the reasoning behind the updates
  • Making comparisons with the previous guidance and identifying significant shifts or emphasis changes
  • Discussing how the new guidelines should be interpreted and implemented to guide novel assay design approaches
  • Introducing case-study examples of the new guidance in practice
  • Discussing potential hurdles and opportunities in implementing revised guidelines
  • Outlining how the new guidance may influence your potency assay strategy going forward