Dawn Henke
Executive director Standards Coordinating Body
Seminars
Wednesday 8th October 2025
Understanding Which Guidance to Adhere to & Leveraging FDARecognized Standards for Raw Materials in Cell & Gene Therapies
9:45 am
- Discussing the current standards under development for raw materials in cell and gene therapy
- Which resources can be used for implementing new standards for raw materials
- Positioning your organization for future regulatory expectations and standardization trends
Thursday 9th October 2025
Panel Discussion: Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development
9:00 am
- Firsthand experience contributing to a new ISO standard, focused on ancillary materials used in advanced therapies
- Overview of the U.S. TAG validation process and transition to a New Work Item Proposal within the ISO framework
- What this upcoming standard means for developers, manufacturers, and regulators over the next 3 to 4 years
