The U.S. Food and Drug Administration recently announced an initiative aimed at phasing out animal testing requirements for monoclonal antibodies and other therapies, and replacing it with potentially more effective, human-relevant methods. Using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting, the new approach aims to improve drug safety and accelerate the evaluation process, while reducing animal experimentation and lowering R&D costs.

Contract Pharma gains insight from CEOs at the forefront of building biotech companies that don’t rely on animal models and what this change might mean for the future of drug development. In the second of this two-part series, Andrei Georgescu, CEO and co-founder of Vivodyne, discusses the company’s humanized drug testing platform using lab-grown tissues that replicate patient physiology, key advantages, and how the industry is working to advance more ethical, efficient, and scalable preclinical innovation.

Contract Pharma: Please describe Vivodyne’s human-first models and how they compare to animal studies?

Andrei Georgescu: Vivodyne human-first models are lab-grown human tissues that replicate the complexity of real human organs — down to all the appropriate cell types and their micro- and macroarchitecture, perfusability through blood vessels, immune function, and more, to a degree where they are indistinguishable from biopsies of native tissue. Vivodyne has developed a platform that uses primary human-derived cells to grow these living tissues by letting them use their biological programming to self-assemble into their native tissue counterparts over the course of about a week, at which point they stabilize and maintain the native function of the human tissue from which they originated. We then use these tissues to directly test new drugs, use functional genomics to modulate genes and discover novel targets, probe for rare adverse effects among diverse patient subpopulations, to assess efficacy and safety against different stages of a particular disease, and more. Vivodyne human tissues provide translatable mechanistic insights and clinical predictions that animal studies often miss, due to the very differences in biological function that makes them different from humans.

The genetic differences that cause mice, dogs, and other animals to be (quite evidently) distinct from humans come as the accumulated product of minute perturbations scattered throughout our genomes, and it is so difficult to predict whether these perturbations will accumulate to allow some specific animal results to translate to humans or not. Given drugs that yield safe and often effective results in animals have a 93% failure rate in human clinical trials, it’s clear that predicting the manifestation of these differences is still an insurmountable challenge to clinical translation.

Unlike these animal models, Vivodyne’s approach to preclinical human testing directly captures human physiological function and responses to drugs in health and disease — for toxicity and efficacy. We can observe whether healthy human tissues become damaged, and if diseased human tissues become healthier when dosed with a therapeutic candidate. And we can see these responses manifest across many orders of complexity, from individual cells signaling to their neighbors, to the complex organ-scale signaling that underlies a disease. This insight deeply reduces translational risk, identifies safety risks earlier, allows us to accelerate efficacious targets and drug candidates, and the vast scale of our automation accelerates the discovery and development of safer and more effective medicines.

Contract Pharma: What does the FDA’s policy shift mean for biotech R&D timelines and regulatory approval?

Andrei Georgescu: The FDA’s recent openness to alternatives to animal testing, including human tissue models and predictive AI, signals a transformative shift in drug development. It opens the door to faster, more clinically relevant R&D timelines by allowing human data-derived evidence to drive early-stage decisions and IND submissions alike.

For companies like Vivodyne, this means that the rapid adoption that we have seen by a majority of the world’s largest pharmaceutical companies is encouraged. Make no mistake; the FDA is strongly evidence-based and has made these decisions in consultation with our very partners. We are excited to enable IND approvals that are attained more rapidly and with lower translational risk, to see fewer late-stage failures that cost many hard years of effort, and ultimately, to enable safer, more effective, and more affordable therapies to reach patients even sooner.

Contract Pharma: What potential drug products would this impact?

Andrei Georgescu: Nearly every category of drug development stands to benefit, but especially the main category that the FDA has identified: precision medicines like biologics, which comprise antibodies, cell therapies, immuno-oncology drugs, and others that depend on the exceptional specificity of these modalities to their human targets — targets for which animals either do not possess a homolog, or whose equivalent target participates differently in signaling pathways than it does in humans.

For example, immunotherapies often show promise in animals but don’t translate to human efficacy or suffer from serious cytokine storms or other safety risks to which mice and even nonhuman primates are not predisposed. The complex immunological complexity of our human tissues provides direct human insights and data that predict how these therapies will behave in people. In Vivodyne’s partnerships, we’re already seeing direct, human-predictive successes in using our human tissues to predict cytokine release syndrome and vasculitis, immunotoxicity and immunosuppression, fibrosis risk, inflammatory responses, and disease-specific therapeutic efficacies for a wide range of precision medicines, biologics, and cell therapies.

Contract Pharma: How is the industry moving toward more ethical, efficient, and scalable preclinical innovation?

Andrei Georgescu: The convergence of biology, automation, and AI is making scalable human-first drug testing a reality. Vivodyne is at the forefront of this shift — we’ve fully automated the complex, rigorous testing of thousands of human tissues in parallel to yield exceptionally rich data that you could previously only obtain from clinical human biopsies, with insight extraction and analysis powered by our active learning and integrative multimodal AI pipelines.

This enables us and our partners to discover novel human biology and prosecute new drug targets, screen candidate compounds against those targets more efficiently, prioritize leads with higher confidence, and dramatically reduce reliance on animals. More importantly, it aligns rapid technological innovation with an improvement in patient outcomes, by merging the two: the innovation is in quite literally testing on patient cell-derived human tissues before testing on those patients to maximize clinical translatability. And ethically, this allows us to directly yield human data without relying on hospital-sized animal vivariums that still have only a fraction of the testing capacity that our platforms do. As regulators, investors, and society continue to push for better science and ethics, we are excited to drive advancement in the ability to harness deep, rich human data before clinical trials.

Andrei Georgescu, is CEO and co-founder of Vivodyne, a biotech developing humanized drug testing platforms using lab-grown tissues that replicate patient physiology. Vivodyne’s fully automated platform can screen thousands of drug candidates using robotics and AI — without touching an animal. They’ve raised over $78M and are partnering with large pharma companies to accelerate preclinical discovery.