FDA's New Roadmap: Emulate Pioneering the Shift Away from Animal Testing
In a major shift, the FDA recently unveiled a strategic roadmap to reduce reliance on animal testing in preclinical drug development by prioritizing the use of New Approach Methodologies (or NAMs). This decision marks a pivotal moment for regulatory science, reshaping how drugs are evaluated for safety and efficacy at early stages of development.
At the forefront of this transformation is Emulate, a company our team invested in and a leader in Organ-Chip systems, a technology highlighted in this initiative. With the FDA embracing Organ-Chips, Emulate’s platform is uniquely positioned to drive innovation, enhance patient safety, and streamline drug development.
Why Organ-Chips Matter
Traditional animal testing often fails to accurately predict human responses to new therapies because human bodies work differently.
By contrast, Organ-Chips integrate human cells on chips to replicate the mechanical and physiological conditions of key organs like the liver, lung, brain, and intestine. Testing drugs in Organ-Chips may provide more accurate early insights into how a drug could affect the human body—helping pharmaceutical companies de-risk drug development and reduce costly late-stage failures.
Emulate’s Role in the FDA’s New Strategy
The FDA’s roadmap outlines a phased transition toward NAMs, starting with monoclonal antibodies and later expanding to biologics and small molecules. Emulate’s Liver-Chip S1 is the first Organ-Chip technology to be accepted into the FDA’s ISTAND Pilot Program. Emulate is working with the FDA to qualify its Organ-Chips to better predict drug-induced liver injury (DILI)—a leading cause of drug failures.
A New Era in Drug Development
As the FDA formalizes guidance for integrating Organ-Chip data into Investigational New Drug (IND) applications, Emulate stands ready to help pharmaceutical innovators navigate this transition, ensuring more effective therapies reach patients faster.
By championing human-relevant models, Emulate isn’t just supporting regulatory evolution—it’s shaping the future of drug discovery, patient care, and ethical scientific research.
