The Business of Biofabrication

By Contract Pharma Staff

Vivodyne, a pioneering biotech developing humanized drug testing platforms, stands positioned to capitalize as the FDA announces its initiative to phase out animal testing requirements for monoclonal antibodies (mAbs) and other drug therapies. With its fully automated platform that uses lab-grown human tissues and AI-driven analysis, Vivodyne is ready to push forward on this regulatory shift — accelerating drug discovery and improving clinical predictability while reducing reliance on animal models.

The company’s platform, which has secured over $78 million in funding and forged partnerships with several major pharmaceutical companies, offers a scalable, human-first approach to preclinical drug testing. By integrating patient-derived cells, robotics, and AI, Vivodyne’s technology enables comprehensive drug screening on thousands of human tissues in parallel, providing rich datasets that better predict human outcomes. This positions Vivodyne as a key player in the FDA’s push for more ethical and effective preclinical models.

Key Highlights from CEO Andrei Georgescu’s Interview with Contract Pharma:

• Vivodyne’s Human-First Models
  Georgescu explained that Vivodyne’s lab-grown human tissues replicate real human organs at a structural and functional level. These tissues include proper cellular makeup, vascular perfusion, immune functions, and organ-level signaling. Such complexity allows Vivodyne to capture drug responses directly in human tissues — assessing toxicity, efficacy, and safety across a wide range of conditions and patient populations. Unlike animal models, which often fail to predict human outcomes, Vivodyne’s platform offers mechanistic insights that translate into clinical relevance.
• FDA’s Policy Shift and Vivodyne’s Advantage
  The FDA’s new direction encourages alternatives to animal testing, including human tissue models and AI-driven tools. This opens the door for faster investigational new drug (IND) approvals and more efficient R&D timelines. Georgescu highlighted that Vivodyne’s adoption by many leading pharmaceutical companies aligns with this regulatory momentum, enabling earlier decision-making based on human data. The shift reduces the risk of late-stage clinical trial failures and accelerates the delivery of safer, more effective therapies to patients.
• Broad Impact on Drug Categories
  Georgescu pointed out that precision medicines — including biologics, antibodies, cell therapies, and immuno-oncology drugs — stand to benefit most from this transition. These therapies often interact with highly specific human targets that animals do not possess or respond to differently. Vivodyne’s models can predict immune responses such as cytokine release syndrome, vasculitis, immunotoxicity, and other adverse effects that are difficult to detect in animal studies.
• Scaling Human-First Innovation
  By combining biological engineering, automation, and AI, Vivodyne delivers scalable testing capacity far beyond traditional animal models. Their platform’s ability to process thousands of human tissues simultaneously enables efficient drug screening and deeper biological insights. This model not only enhances drug discovery but also aligns with societal and investor demands for more ethical science, replacing the need for large-scale animal vivariums with high-throughput human data generation.

As the FDA’s policy shift reshapes the landscape of drug development, Vivodyne is well-positioned to lead this transition, driving forward a model of preclinical innovation that prioritizes human biology, reduces translational risk, and expedites the delivery of new therapies.

About Vivodyne

Vivodyne has raised over $78 million in funding and continues to collaborate with top pharmaceutical companies to drive forward this next generation of drug discovery. The company’s mission to integrate human biology into early drug development represents a key milestone in the broader effort to improve clinical translation and patient outcomes.

Original Interview can be found here.