VoxCell Welcomes FDA’s Shift to Reduce Animal Testing and Drive Human-Relevant Models

Victoria, April 2025 - VoxCell BioInnovation Inc., a leader in in vitro modeling with best-in-class 3D vascularized tissue models, applauds the U.S. Food and Drug Administration’s (FDA) newly announced strategic roadmap to reduce reliance on animal testing in preclinical safety studies. This transformative shift showcases the regulatory body's commitment to modernizing drug safety evaluation through New Approach Methodologies (NAMs) that prioritize human-based models, such as VoxCell's 3D vascularized models.

The FDA’s strategic roadmap begins with monoclonal antibodies (mAbs). It will expand to other biologics and small-molecule drugs, emphasizing innovative in vitro systems designed to better replicate human physiology and improve predictive accuracy in drug safety and efficacy testing.

View FDA's Roadmap

"This is an exciting time for VoxCell as it aligns with our 3D bioprinted vascularized human-like tissue models. The FDA’s plan emphasizes the adoption of New Approach Methodologies (NAMs), including human-based laboratory models, to simulate human physiological responses more accurately than traditional animal testing. This is a transformative step forward for drug development."

Dr. Karolina Valente, CEO of VoxCell BioInnovation

“At VoxCell BioInnovation, we celebrate this pivotal moment as it aligns directly with our mission to develop 3D bioprinted, vascularized human-like tissue models,” said Dr. Karolina Valente, CEO of VoxCell. “Animal models often fail to predict human responses, particularly for complex biologics. The FDA’s vision to adopt human-based laboratory models like ours marks a significant step toward more ethical, efficient, and relevant drug development.”

Vascularized human-relevant tissue models accurately replicate key physiological features of human biology, including the transport of nutrients and oxygen through the microvasculature. By incorporating perfusable vascular networks, these advanced in vitro systems allow for more accurate simulation of how drugs behave in the human body. These models support the assessment of toxicity, efficacy, and tissue response in ways that traditional animal studies cannot.

The FDA echoed this urgency in its roadmap:

“NAMs offer the tools to assess safety, efficacy, and pharmacology of drugs and therapeutics without traditional animal models... [and] provide faster and more accurate human risk assessments while reducing animal use.”

U.S. Food and Drug Administration (FDA) Roadmap

This recent initiative highlights the importance of collaborative progress, uniting regulatory agencies, industry members, and academic researchers. VoxCell is proud to be at the forefront of a new era in drug development, which reduces animal use, de-risks early-stage research, and brings safer, more effective therapies to patients more quickly.

About VoxCell BioInnovation

VoxCell BioInnovation is a leading provider of next-generation in vitro models, powered by our 3D bioprinted, vascularized tissue technology. Our ready-to-perfuse models closely replicate human biology with in vivo–like microvascular networks, enabling nutrient and oxygen delivery, systemic drug distribution, and more predictive therapeutic responses. VoxCell’s end-to-end solution offers researchers and pharmaceutical companies a scalable, ethical alternative to animal testing. Our mission is to reduce reliance on animal models, accelerate preclinical development, and advance more effective therapies for patients.

Want to learn more or collaborate?

Visit our website, connect with us on LinkedIn, or email us at hello@voxcellbio.com.