Renee Hart
President & Chief Business Officer LumaCyte
Seminars
Wednesday 16th September 2026
Panel Discussion: Designing Commercial Manufacturing for Speed or Scale & the Regulatory Trade-Offs
3:00 pm
- Debating whether commercial manufacturing should prioritize commercial scalability from day one or focus on the fastest path into the clinic, and how each choice shapes regulatory strategy
- Examining how early process design and analytical development decisions impact potential CMC approval for commercial studies