Roundtable Discussion: Preparing for IND Filing Leveraging Only Complex In Vitro Model Data
- Spotlighting how advanced in vitro and ex vivo systems can build a robust mechanistic evidence package, demonstrating target engagement, pathway modulation and early efficacy signals in human‑relevant biology in place of in vivo data
- Demonstrating strategies to strengthen regulatory confidence, including rigorous model qualification, reproducibility controls, metadata standardization and cross‑platform validation to address questions typically answered by in vivo studies
- Explaining how to map ex vivo and complex in vitro readouts to IND‑enabling requirements, aligning short‑term functional data with safety, exposure and translational expectations to support a defensible submission pathway