BOSTON--(BUSINESS WIRE)--Emulate, Inc., a leading provider of next-generation in vitro models, today welcomed the U.S. Food and Drug Administration’s (FDA) newly announced plan to reduce reliance on animal testing in preclinical safety studies. The FDA’s strategic roadmap outlines how New Approach Methodologies (NAMs), including Organ-Chips, advanced computational modeling, and other in vitro assays, will help streamline drug development, lower costs, and improve patient safety.
The FDA’s roadmap prioritizes the use of cutting-edge human-relevant systems for evaluating potential therapies—starting with monoclonal antibodies (mAbs) and eventually expanding to other biologics and small-molecule drugs. Among the NAMs specifically highlighted are Organ-on-a-Chip technologies, which more accurately replicate human biology and disease states compared to traditional animal models.
“The FDA’s vision for modernizing regulatory science marks a major turning point in preclinical research,” said Jim Corbett, Chief Executive Officer of Emulate. “By embracing Organ-Chips and other innovative, human-based methods, the FDA is simultaneously promoting patient safety, accelerating the delivery of new therapies, and reducing animal use. We believe this is the start of a new paradigm that benefits patients, researchers, and the entire healthcare ecosystem.”
Organ-Chips integrate human cells within micro-engineered environments that emulate key aspects of organ function, including mechanical forces and physiological flow. These microphysiological systems (MPS) can be used to detect potential toxicities, immunogenicity, and pharmacodynamic effects that often go undetected in animal studies. As outlined in the FDA’s roadmap, such in vitro models help companies de-risk projects early, make faster go/no-go decisions, and reduce costly late-stage failures.
“Traditional animal and reductionist models are limited because they simply do not capture the complexity of the human body,” stated Dr. Lorna Ewart, Chief Scientific Officer of Emulate. “With Organ-Chips, we can explore biological mechanisms of health and disease in a setting that more closely mirrors human physiology. Our goal is to empower pharmaceutical and biotech companies to generate more predictive data, ultimately yielding safer, more effective treatments for patients.”
According to the FDA’s announcement, regulatory guidance will be developed to clarify how sponsors can incorporate Organ-Chip data into their Investigational New Drug (IND) applications. The agency will also coordinate with fellow federal entities, including the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA), through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). This collaboration aims to create robust, validated approaches and to build a comprehensive data repository that accelerates global adoption of NAMs.
Emulate’s platform, which includes Organ-Chips for the liver, lung, intestine, brain, kidney, and other organs, is well-positioned to support pharmaceutical and biotech innovators looking to align with the FDA’s roadmap. Notably, the Emulate Liver-Chip S1 has already been accepted into the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program—the first Organ-on-a-Chip technology to reach this milestone. As part of this program, Emulate is actively working with the FDA to qualify its Liver-Chip for evaluating drug-induced liver injury (DILI) in IND submissions. As DILI remains a leading cause of drug attrition, this achievement underscores the power of human-relevant, micro-engineered systems to predict hepatotoxicity more accurately than traditional methods.
Together, these two recent initiatives are paving the way for broader acceptance of drug development tools that do not fit into established regulatory pathways, and Emulate is proud to be at the forefront of this movement—supporting faster, safer, and more cost-effective development of life-saving therapies.
About Emulate, Inc.
Emulate is a leading provider of next-generation in vitro models, pioneering the use of Organ-Chips to enable more predictive and ethical scientific research. By leveraging HUMAN BIOLOGY + TECHNOLOGY, Emulate aims to ignite a new era in human health research—one that reduces animal testing, cuts drug development costs, and accelerates the delivery of life-saving treatments. Our team is committed to setting a new standard for how we study biology, discover therapies, and create cures for patients who need them most.
Contacts
For media inquiries or additional information, please contact:
Name: Rebecca Bonfig
Email: PRCommunications@emulatebio.com
