On October 19th, ARM and ASGCT will hold a meeting with FDA on the topic of potency assays for cell and gene therapies. The meeting will take place from 9 AM to 4 PM and will be live streamed for public viewing. Use the following links to register to view the live stream, which includes one for the main room, and a second for the breakout room:
Fenton – Main Room
Bair – Breakout Room
There will be a brief Q&A session during the event.
As a result of this meeting, a White Paper on the subject of potency assay challenges was developed. You can view it by clicking here.