Setting Up for IND Success to Streamline Preclinical & Translational Progression
Time: 1:00 pm
day: Pre-Conference Workshop Day Pink Track P2
Details:
As the regulatory bar for autoimmune cell therapies continues to rise, it is essential to align your preclinical strategies with evolving FDA expectations. This workshop will explore how to effectively set up your laboratory and generate the right data to support IND submission.
- Outline the essential preclinical data packages and study types needed to support a successful IND submission
- Address challenges in data collection, imaging, and assay development to ensure effective translation from lab to clinic
- Evaluate the opportunity to shift away from mouse models and its implications for therapeutic development and regulatory confidence
- Identify current gaps in IND-enabling studies and strategies to support efficient regulatory progression
