Synopsis
Animal models have served as the default standard in preclinical research for decades, but their limited predictive value for human outcomes continues to slow drug development and contribute to high attrition rates. Recent regulatory milestones—including the FDA’s roadmap to reduce animal use, the NIH’s prioritization of human-relevant models, and Emulate’s own Liver-Chip S1 acceptance into the FDA ISTAND program—signal a decisive shift toward New Approach Methodologies (NAMs).
In this webinar, hosted in conjunction with the Physician’s Committee for Responsible Medicine, Emulate’s Dr. Daniel Levner, Chief Technology Officer, will share how the FDA’s ISTAND qualification of the Liver-Chip S1 represents a pivotal step for regulatory recognition and broader adoption of Organ-on-a-Chip technology. Attendees will gain insight into how this breakthrough aligns with global initiatives to reduce animal testing, the scientific validation underpinning the platform, and practical strategies for integrating Liver-Chip data into regulatory submissions.
Key learning objectives
- Understand what FDA ISTAND acceptance means for the regulatory qualification of Organ-on-a-Chip technology and its impact on drug development.
- Learn how Emulate’s Liver-Chip S1 is poised to meet FDA expectations for context of use, building on strong scientific evidence and cross-industry collaboration.
- Explore the FDA’s roadmap to reduce animal usage and how Organ-on-a-Chip technology can future-proof your pipeline against evolving regulatory standards.
- Identify strategies for incorporating Liver-Chip data into IND submissions to increase confidence, improve predictability, and accelerate decision-making.
