In a landmark move, the U.S. Food and Drug Administration (FDA) has released a detailed roadmap for significantly reducing animal testing in preclinical safety studies. The initiative embraces validated New Approach Methodologies (NAMs) including organ-on-chip platforms, in silico models, and advanced human in vitro assays. For those of us at Ncardia, this is more than a regulatory evolution—it’s a validation of a vision we’ve long championed.
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FDA’s Roadmap Signals a Paradigm Shift: The FDA’s new strategy supports the integration of validated New Approach Methodologies (NAMs), including human in vitro systems and computational models, as alternatives to animal testing in preclinical safety studies.
Ncardia Welcomes the Change: As a pioneer in iPSC technology, Ncardia views this as a long-awaited and exciting opportunity to advance more human-relevant, ethical, and predictive drug development practices.
Aligned with FDA Priorities: Ncardia’s platforms are ready to support pharma and biotech companies adapting to the FDA’s NAM-friendly regulatory environment—enhancing predictivity, reducing time-to-market, and lowering reliance on animal models.
The FDA's new roadmap outlines a phased approach to minimizing animal use across biologics and small molecules, beginning with monoclonal antibodies. It recognizes the scientific limitations of animal models—over 90% of drugs deemed safe in animals ultimately fail in humans, often due to unforeseen safety or efficacy issues.
With this initiative, the FDA has opened the door to data generated through human cell-based platforms, computational modeling, and other NAMs in regulatory filings. By explicitly welcoming these approaches in Investigational New Drug (IND) applications, the agency aims to improve decision-making and reduce both cost and time to market.
Public and political support has accelerated this shift. The FDA Modernization Act 2.0 removed the requirement for animal testing in many cases, and in 2024, the FDA Science Board endorsed NAMs as part of regulatory science modernization. With broad momentum, NAMs are no longer futuristic—they are today’s regulatory reality.
At Ncardia, we’ve always believed in the power of human biology to revolutionize drug discovery and development. Our platforms, built on iPSC-derived cells, directly align with the FDA’s goals to improve translational relevance, reduce timelines, and minimize animal use. With this FDA announcement, we’re not just aligned—we’re ready to lead.
Our flagship solutions, including Ncyte® vCardiomyocytes, are designed to strike the perfect balance between throughput and physiological relevance. Produced in stirred-tank bioreactors with yields of up to 10 billion cells per batch, they provide ample volume to support multi-year screening campaigns using a single, consistent cell lot—minimizing the need for revalidation and saving valuable development time. And when a new batch is needed, our highly controlled production process ensures exceptional consistency in cell purity, viability, and, most importantly, functional performance—so researchers can rely on reproducible results from one campaign to the next.
But we haven’t stopped there. Our latest innovation, Ncyte® Heart-in-a-Box™, represents a significant leap forward. This advanced 3D cardiac microtissue model integrates seamlessly into high-throughput, automated workflows—delivering a physiologically relevant, human-based platform that enhances both efficiency and predictive power. With Ncyte® Heart-in-a-Box™, researchers can now screen up to 1,500 data points per day with exceptional robustness and reproducibility—bringing unprecedented scale to human-relevant cardiac testing.
Looking ahead, we're expanding our portfolio with another groundbreaking innovation: Ncyte® NHP-C vCardiomyocytes. Set to launch soon, this will be the first-ever availability of cardiomyocytes derived from non-human primates (NHPs) for research use. This product represents a major advancement in ethical and translational preclinical safety testing—offering a powerful alternative to in vivo NHP studies with great potential to reduce animal use.
The FDA’s report underscores the importance of predictive, human-relevant models. Traditional animal studies often fail to detect toxicities that only emerge in humans. NAMs—particularly those using human cells—offer a solution.
iPSC-derived models like ours replicate native human biology with remarkable fidelity. Ncyte® vCardiomyocytes, for example, exhibit functional and electrophysiological properties akin to native human heart cells. When used in early screening, they can flag pro-arrhythmic compounds and cardiotoxic profiles before clinical trials even begin.
Moreover, NAMs are inherently more scalable and cost-effective. In silico modeling, organ-on-chip platforms, and high-content screening systems all contribute to more agile development pipelines.
The FDA’s roadmap outlines specific priorities that mirror our development philosophy:
Reduced reliance on animal models for safety testing. Our iPSC-derived cardiac and neuronal models are already used as predictive tools in leading therapeutic pipelines.
Integration of human-based assays into regulatory submissions. Our platforms produce high-quality, reproducible data that can support INDs and de-risk clinical entry.
Encouragement of high-throughput, automated solutions. Ncyte® Heart-in-a-Box™ is built for high-throughput compatibility, enabling efficient and scalable compound profiling with a highly relevant model.
With these aligned goals, we see a unique opportunity to support pharma leaders in adapting to the FDA’s evolving standards—ensuring safety assessments are not just compliant, but cutting-edge.
We applaud the FDA’s vision and welcome the collaborative spirit embedded in their roadmap. From public-private partnerships to interagency data sharing initiatives, the FDA is paving the way for a unified regulatory shift. At Ncardia, we stand ready to contribute—through joint research, data validation, and continued innovation in iPSC-based models.
As we look to the future, our message to pharma and biotech R&D leaders is clear: the tools to replace animal models aren’t just theoretical—they’re available now. The question is no longer “if,” but “how fast” you can implement them.
By embracing iPSC-based NAMs today, you position your pipeline at the forefront of a regulatory revolution. Let Ncardia be your partner on this journey—from early screening to IND submission—with models that deliver the physiological insight, throughput, and reliability your teams need to succeed.
We invite drug innovators and preclinical scientists to connect with us. Let’s drive the change together—toward better science, safer therapies, and a world where drug development truly reflects the biology of the patients we aim to serve.
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