NAMs News
October 19 - 23, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Critical appraisal of the EC roadmap: Navigating sociotechnical barriers to the regulatory acceptance of NAMs
In a new paper, researchers from the University of Birmingham analyse the extent to which the strategic ‘Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments’ of the European Commission (EC) is able to address sociotechnical barriers that have thus far hindered the greater regulatory acceptance of New Approach Methodologies (NAMs).
A review of legal frameworks underpinning the roadmap identifies that more extensive statutory interpretation, particularly regarding the use of Weight-of-Evidence, would aid regulatory acceptance of NAMs. The paper notes the absence of consideration of the EU judicial system, and that without hard milestone dates by which to indicate progress, the roadmap as a strategy is only able to provide limited clarity that NAM innovators and investors seek.
2. New issue on ALTEX: R3FINE 2026, validation by design, modernizing vaccine safety, bridging disciplinary gaps, AI virtual cell platforms
In the latest issue on ALTEX Journal, some key articles related to NAMs are available:
- Food for thought: Validation by design: Model-informed validation design (MIVD) as a quantitative design science – Hartung
- Food for thought: A roadmap for modernizing vaccine safety assessment: Challenges and opportunities for new approach methodologies – Sillé et al.
- Meeting report: R3FINE 2026: Bridging disciplinary gaps in translational animal-free research – Serdengeçti et al.
- Article: Beyond the drug-centric view: Advancing AI virtual cell platforms for environmental perturbation modelling – Ukaegbu et al.
- Article: Towards advanced in vitro models of testicular steroidogenesis for endocrine disruption testing – Rosenmai et al.
3. Awareness and perspectives of translational assessment tools in preclinical research: Insights from a survey
Preclinical research often fails to translate into clinical benefits, contributing to high drug development failure rates. A new study from the Biomedical Research for the 21st Century (BioMed21) Collaboration surveyed 105 stakeholders to assess awareness and use of tools designed to evaluate the translational relevance of preclinical research.
Although participants recognised the value of existing assessment tools, familiarity was limited. Key barriers included poor standardisation, limited human data, and uncertainty about assessment validity. Improving access to these frameworks could strengthen preclinical research and promote more human-relevant biomedical studies.
4. NAMs and MPS in the European Biotech Act: An encouraging policy signal
The European Parliament’s ENVI Committee has adopted its Opinion on the EU Biotech Act, with several amendments addressing the development, validation, standardisation and regulatory integration of NAMs, including Microphysiological Systems (MPS).
This is an encouraging development for the NAMs community. However, political recognition alone is not enough: the challenge now is to translate this momentum into tangible progress.The legislative process is still ongoing. Continued engagement between policymakers, regulators, scientists and industry will be essential to turn this policy momentum into concrete progress for NAMs.
INTERVIEWS, NOMINATIONS & AWARDS
5. UC Berkeley receives funding from Google.org to accelerate scientific breakthroughs with AI
UC Berkeley researchers led by Emma Pierson (EECS) and Ziad Obermeyer (Public Health) have been awarded $1.7 million through Google.org Impact Challenge: AI for Science. The research grant will support advancements in medical discovery using AI interpretability and agentic AI techniques. “We’re at an extraordinary moment for science, as advances in AI open up new possibilities for discovery that were difficult to imagine just a few years ago,” said Leslie Yeh, director of scientific progress at Google.org.
A group of scientists led by Joseph Brown, assistant professor at the Leslie Dan Faculty of Pharmacy, has received $2.3 million through the same funding scheme. The newly funded initiative, OpenPep, will lead to an open access database that will allow researchers to use AI to predict which peptides will bind to target proteins. “AI has the potential to transform how we understand biology and accelerate the discovery of new therapeutics,” said Leslie Yeh.
Read more on the UC Berkley project
Read more on the OpenPep project
6. Unilever’s science, advocacy and collaborations to end animal testing globally
Unilever has pioneered alternatives to animal testing for decades. In a new interview, Dr Gavin Maxwell, Unilever’s Head of Regulatory Science Strategy & Advocacy, shares why regulators are increasingly ready to adopt non-animal safety science.
Key takeaways are:
- Unilever has used non-animal safety science methods since the 1980s and advocates for a total global ban on animal testing for cosmetics
- Instead of animal testing methods, its scientists use computational approaches, data modelling and AI, collaborating with partners all over the world to advance progress
- October 2026 marks eight years since Dove, Unilever’s biggest Power Brand, was certified as PETA approved and Unilever was recognised by PETA as a company working for regulatory change
7. Nina Zhao: “We live in a chemical world”
The “Research Matters” series visits labs across campus to hear directly from Stanford scientists about what they’re working on, how it could advance human health and well-being, and why universities are critical players in the nation’s innovation ecosystem. Nina Zhao is building a program to accelerate the investigation of environmental chemicals.
“At Stanford, I am building a research program that uses [such] computational approaches to make the investigation into environmental chemicals faster and more systematic.” “I want to achieve better predictive power for the health outcome of each individual. Now, with the help of AI, what took months in the past probably takes me only days to weeks.” she says.
TOOLS, PLATFORMS, CALLS
8. CN Bio: A technology guide to assessing liver safety with MPS
Assessing liver safety is one of the highest-stakes decisions in preclinical development. Liver MPS or Liver-on-a-chip models provide a more human-relevant environment in which to investigate Drug-induced liver injury (DILI) risk. By incorporating fluidic flow and engineered tissue microenvironments, liver MPS can help sustain hepatocyte function and metabolic activity over extended culture periods. Depending on the research question, models may combine primary human hepatocytes with Kupffer cells or other supporting cell types, enabling repeat-dose studies and the investigation of metabolic, inflammatory and other mechanistically complex responses.
A new technology guide from CN Bio is designed to support researchers deciding whether, where, and how liver MPS could strengthen their approach to assessing liver safety.
Read more and download the guide
INDUSTRY, BIOTECH & PARTNERSHIPS
9. Danaher accelerates life sciences research with new AI-powered autonomous lab
Danaher Corporation announced plans to launch its first AI-powered autonomous lab, designed to help researchers develop custom antibodies and other molecular tools faster and more efficiently.
Expected to operate at scale in early 2027, the lab will combine artificial intelligence, robotics and technologies from several Danaher operating companies in one connected workflow. It is the first step in a broader Danaher initiative to create smart instruments, integrated workflows and autonomous labs that accelerate scientific research. The platform reflects an important milestone in the company’s continued investment in connected science at a global scale: technologies designed to help researchers move from scientific question to validated answer with greater speed, consistency and confidence.
10. VoxCell BioInnovation and abc biopply partner to bring perfused vascularized human tissue models to European drug development
VoxCell BioInnovation Inc., a developer of bioprinted vascularized human tissue models for preclinical drug development, and abc biopply, a Swiss contract research organization (CRO) and Europe’s first fully integrated Organoid CRO, announced the signing of a Letter of Intent to collaborate on bringing VoxCell’s perfused, vascularized human tissue models to drug developers in Europe.
The partnership responds to growing demand for NAMs that improve the human relevance of preclinical testing and reduce reliance on animal models. VoxCell’s models provide perfused, endothelial-lined vasculature inside 3D human tissues, a capability that complements abc biopply’s humanized organoid platform and preclinical expertise.
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Two RISK-HUNT3R case studies published in the OECD IATA Series
Two case studies developed within RISK-HUNT3R have been published following the 11th review cycle (2025) of the OECD Integrated Approaches to Testing and Assessment (IATA) Case Studies Project.
The two publications explore different approaches to chemical safety assessment:
- Propylparaben (OECD No. 448): Application of the Alternative Safety Profiling Algorithm (ASPA), developed within RISK-HUNT3R as part of the ASPIS cluster, to assess potential systemic toxicity considering exposure from multiple sources.
- Conazoles (OECD No. 447): Assessment of systemic toxicity using an integrated read-across approach.
These publications represent an important milestone for RISK-HUNT3R, demonstrating how different sources of evidence and NAMs can be integrated into structured chemical safety assessments.They also reflect a substantial collaborative effort across the consortium, bringing together scientific expertise and contributions from multiple partners.
12. Human brain organoids in space helped lead to the clinical trial of a potential therapy
Research using human brain organoids onboard the International Space Station (ISS) helped lead to the clinical trial of a potential therapy for Rett syndrome, a debilitating neurological disorder in children.
In organoids made from the cells of children with Rett syndrome, neuroscientist Alysson Muotri’s team at the University of California San Diego found that normally dormant genetic elements had switched on, triggering inflammation in the brain’s support cells. That finding led the researchers to test lamivudine, an antiretroviral drug developed for HIV, as a possible way to reduce the inflammation. The work has since helped lead to a clinical trial now underway for patients with Rett syndrome.
WORTH (RE)SHARING
How scientists used AI to create ultra-stable, freezer-free mRNA vaccines – Drug Discovery News
PeerCore: Calling all toxicologists who want to improve their skills in peer-review
Enhancing Europe’s competitiveness by empowering researchers as innovators – Science
Guidance Document for In Vitro Testing of the Intestinal Fate of Orally Ingested Nanomaterials – OECD
Is it time to bring organoids into your lab? – Science
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
International Conference on Organoid Intelligence 2026 – October 26, 2026, Washington DC (USA)
15th meeting of the American Society for Cellular and Computational Toxicology (ASCCT) – October 26, 2026, Durham, NC (USA)
13th Annual 3Rs Symposium: Innovative Uses for the 3Rs – November 2, 4, & 10 — 10:00am‑1:30pm ET (online), November 12 — 8:30am‑5:00pm PT (online & in-person)
