From Bench to IND: De-Risking the Regulatory Journey for Cell & Gene Therapies
Time: 3:30 pm
day: Conference Day Two
Details:
- Building a Scalable Regulatory Strategy Early: How to align CMC, preclinical, and clinical planning from day one to avoid costly delays at IND submission
- Common Pitfalls & Lessons from First-Time Filers: Real-world examples of what slows – or sinks – CGT INDs, from poor comparability planning to underpowered preclinical data
- Smart Use of Regulatory Interactions: How to make the most of Type B meetings, INTERACT meetings, and other FDA pathways to shape a clear and confident path to first-in-human trials
