Building an IND Package Leveraging In Vitro Only Data for Cell Therapy

• Discussing the need to leverage in vitro cell-based models over mouse models
• Showcasing the types of data to gain from these models to determine some aspects of safety profiles
• Sharing how this data supports building an IND package to the FDA to gain approval for FIH studies where safety will be further determined

Speakers:

Collin Walter

Senior Scientist

Regeneron