PROGRAM OVERVIEW
The ISTAND Pilot Program provides a pathway for qualifying innovative drug development tools (DDTs), including microphysiological systems and other New Approach Methodologies. Once qualified, these tools can be used across multiple drug development programs without re-qualification, streamlining regulatory submissions and reducing development risk.
QUALIFICATION MILESTONES
- 2022: Emulate Liver-Chip first MPS to receive ISTAND qualification
- Context of Use: Identification of DILI risk in drug candidates
- Validation Data: 87% sensitivity for hepatotoxicity prediction
- 870 compounds tested: Largest organ-chip validation dataset
QUALIFICATION PROCESS
- Stage 1: Letter of Intent and initial consultation
- Stage 2: Qualification Plan submission and review
- Stage 3: Full Qualification Package submission
- Stage 4: FDA review and qualification decision
- Stage 5: Public announcement and context of use documentation