Synopsis
In this fireside chat hosted at Emulate headquarters on June 17, 2025, leaders from academia, industry, and regulatory agencies explored the growing role of New Alternative Methods (NAMs)—including Organ-on-a-Chip technology—in transforming preclinical drug testing. Panelists included Dr. Donald Ingber (Wyss Institute), Dr. Tracy Beth Høeg (FDA), Dr. Lorna Ewart (Emulate), and Dr. Samantha Atkins (Moderna). The discussion addressed recent FDA policy shifts, scientific validation of Organ-on-a-Chip technology, and its adoption in pharmaceutical pipelines.
Key highlights from this event include how:
- The FDA is prioritizing NAMs for biologics like monoclonal antibodies, with a stated goal of making animal testing the exception in IND submissions within 3–5 years. The agency is encouraging early engagement and aims to publish use cases to expand adoption.
- Emulate’s Liver-Chip demonstrated 87% sensitivity and 100% specificity in predicting drug-induced liver injury (DILI), significantly outperforming animal models and offering up to a $3B/year productivity gain for pharma companies.
- Moderna uses Liver-Chips to downselect mRNA-LNP candidates prior to costly nonhuman primate (NHP) studies, reducing animal use while increasing confidence in safety and efficacy outcomes.
- Organ-Chip systems allow precise modeling of complex disease mechanisms such as thrombosis, inflammatory bowel disease, and viral infection, offering insights not observable in animals or traditional assays.
- Immune cells and microbiomes can be used in chips to replicate clinically relevant conditions, enabling the study of vascular injury, host-microbiome interactions, and co-morbidities in a human-relevant environment.
- AI and in silico models are increasingly used alongside Organ-Chips to accelerate drug discovery, predict responses, and identify novel therapeutic targets, particularly in rare diseases and drug repurposing efforts.
- Moderna and others observed high reproducibility across chip experiments, building trust within organizations and promoting cultural shifts toward replacing traditional models with robust NAM platforms.
- The launch of Emulate’s AVA platform increases throughput and lowers cost, enabling users to run up to 96 Emulations simultaneously with integrated imaging and data analytics to support broader adoption in industrial settings.
This discussion underscored the scientific, regulatory, and economic momentum behind NAMs and Organ-on-a-Chip technologies and highlighted how collaborative action is catalyzing a shift toward a more ethical, predictive, and human-relevant paradigm in drug development.