09.09.2025 | Published by bit.bio
Blog
Back to blogs
At the 13th World Congress on Alternatives and Animal Use in the Life Sciences (WC13) in Rio de Janeiro, 2025, we (Sebastian Fiedler, Applications Marketing Manager and Tom Brown, Senior Product Manager both from bit.bio) joined researchers, policymakers, and industry leaders to discuss the future of science without animals. The message across sessions was clear: the transition away from animal testing is inevitable.
For the first time in Latin America, the congress unfolded against the backdrop of Brazil’s nationwide ban on cosmetic animal testing, a powerful symbol of the momentum building worldwide. What struck us most was how the conversation has shifted. The debate is no longer if animal models can be replaced, but when. Across disciplines WC13 revealed a global consensus: human-relevant science is the future.
A turning point in global science
Dr Gavin Maxwell’s (Head of Regulatory Science Strategy & Advocacy, Unilever) keynote, “Paradigm Shift in Progress: Witnessing the Worldwide Adoption of Animal-Free Safety Science,” was one of the outstanding talks of the conference. Maxwell, an immunologist and industry leader in regulatory science, drew from over 20 years of experience developing non-animal safety assessment methods. He described how new approach methodologies (NAMs), from in vitro assays to in silico models, have moved from experimental pilots to regulatory acceptance around the world.
At one point, Maxwell posed a direct question to the audience: “When it comes to regulatory adoption of next-generation risk assessment (NGRA) approaches, do you believe we are past the tipping point, just passing it, or not there yet?” The response was mixed. Only one person felt we were past it, around 30–40% thought we were just passing it, while the majority said we have not yet reached it.
That exchange captured the mood in the room. The scientific case for NGRA is strong, and regulators are increasingly open to it, but confidence in its full regulatory uptake is still building. For us, this moment highlighted both the progress already made and the scale of the challenge ahead: bridging the gap between technological readiness and regulatory certainty.
Building ethical careers
Dr Kathrin Herrmann, from Johns Hopkins University’s Center for Alternatives to Animal Testing (CAAT), turned the spotlight on people. Her session, “Pioneering Animal-Free Careers: Ethical Pathways in Biomedical Research,” explored how the rise of animal-free science is reshaping professional opportunities.
She pointed to breakthroughs in organ-on-chip technology, 3D tissue systems, and AI-driven models that are opening new roles in academia, biotech, and regulatory agencies. For early-career scientists, the message was empowering: the chance to pursue a career that is both ethically grounded and scientifically cutting-edge.
By being selective and questioning from the start, researchers can steer their careers toward driving the cultural change that will make animal-free science the default.
What we found particularly valuable was her encouragement for young researchers to be critical about the projects they choose for their PhD work, a postdoc project, or their first role in industry. Herrmann stressed the importance of asking tough questions at the outset: Will this work advance human-relevant science? Will it rely heavily on animal models, or does it open the door to NAMs?
AI in toxicology: Now and next
Few topics attract more attention than the transformative impact of AI. Professor Thomas Hartung, Director of Johns Hopkins University's CAAT, explored this in his session, “AI in Toxicology: The Now and the Next.” He argued that AI has already begun to outperform animal studies in predicting toxic outcomes, and that the next frontier is integration with experimental human biology.
In the “now,” AI screens vast chemical libraries and flags risks with accuracy that rivals animal tests. In the “next,” generative models could design safer chemicals from scratch, while advanced neural networks analyse complex datasets from human-cell assays. Hartung described this as the emergence of “ToxAIcology”, using AI not only to predict outcomes but to uncover mechanisms of toxicity.
His talk captured the excitement and responsibility of this moment. With quality data and validation, AI could accelerate the full adoption of NAMs, making toxicology faster, cheaper, and more human-relevant.
A new US institute for organiod modelling
Dr Nicole Kleinstreuer, Director of NICEATM and ICCVAM at the National Institutes of Health, used her session to underscore the momentum behind New Approach Methodologies (NAMs). She highlighted the recent announcements from both the FDA and NIH that signal a clear shift toward human-relevant models.
Central to this is Complement-ARIE, an NIH Common Fund program launched to accelerate the development, standardisation, validation, and deployment of NAMs. The initiative includes Technology Development Centers to build advanced NAM platforms, a NAMs Data Hub & Coordinating Center for FAIR data and model credibility, and a Validation and Qualification Network (VQN), a public-private collaboration that will define validation frameworks, reporting standards, and quality systems for regulatory acceptance.
A key announcement was the launch of the Standardised Organoid Modelling (SOM) Center, a new resource dedicated to organoid-based NAMs across critical tissues including liver, heart, lung, and intestine.
Kleinstreuer closed by setting out her vision for the future: a continuous One Health learning loop of prevention, protection, and progress, supported by data-driven personalisation, and data-informed safety and sustainability.
The “When, not if” moment
Across these sessions, one message rang clear: the convergence of policy, technology, and culture means the transition to animal-free science is no longer hypothetical.
On the policy side, recent moves from Brazil’s ban to the FDA’s roadmap for NAMs show that regulators are actively enabling the shift. On the technology side, advances in iPSC-derived human cells, organoids, and AI tools are proving that animal-free testing can be not only ethical but scientifically superior.
What impressed us most at WC13 was the collective mindset. Instead of debating whether to replace animal models, the conversation has shifted to how fast and by what means. Challenges remain, from validation to harmonisation, but the determination to solve them was palpable.
Leaving WC13, we felt convinced that we are standing at a turning point. Each new dataset, each validation study, each policy change is accelerating the move toward a research ecosystem built on human biology, not animal surrogates.
The consensus across disciplines was unmistakable: the shift is happening, and it’s a matter of “when, not if.” WC13 did not just showcase progress; it showcased a community united in creating a safer, more ethical, and more effective future for science.