News on non-animal methods
FEBRUARY 16 - 20, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Transforming chemicals and cosmetics assessment
Carcinogenicity assessment
Assessing the safety of chemicals used in our daily life is essential, especially when it comes to their potential to cause cancer. This is what we call ‘carcinogenicity assessment’. Traditionally, chemicals are assessed by exposing mice or rats every day for two years and examining whether the animals develop tumours. This approach is very time-consuming, costly in terms of money and the large numbers of animals used, and it does not always provide a reliable prediction to humans. To overcome these limitations, scientists are increasingly moving towards a more biologically-relevant approach to increase the efficiency for evaluating chemical carcinogenicity to humans.
The Joint Research Center is contributing to this transition. Together with the Organisation for Economic Co-operation and Development (OECD), the JRC is developing an integrated approach to assess chemicals that can cause cancer without directly damaging our DNA, known as ‘non-genotoxic carcinogens’. The lack of validated methodologies to evaluate these substances represents an important gap in current regulatory safety assessment.
Cosmetics assessment
Under the European Cosmetic Regulation, safety assessments of cosmetics and their ingredients must be conducted without the use of animals. Despite significant progress since the ban in 2013, there remains an urgent need for non-animal test methods to assess systemic toxicity, which often becomes evident after repeated or long-term exposure.
In response to these challenges, the Methodology Working Group of the Scientific Committee on Consumer Safety (SCCS) organised a dedicated workshop in December 2024 to discuss advances in the application of Next Generation Risk Assessment (NGRA) as a strategic animal-free approach. A newly developed template outlining readiness criteria for NAMs (New Approach Methodologies) was introduced by the EU’s Joint Research Centre. It was suggested that they could support the SCCS in evaluating the scientific validity of NAMs before their potential use in the safety assessment of cosmetic ingredients.
2. Bioconvergence: The new performance driver for the living world
At the start of 2026, early human data has started to become the regulatory gold standard, propelled by Environmental, Social and Governance (ESG) requirements and the end of systematic animal testing. The integration of biology, physics and data science is giving rise to a major new discipline: bioconvergence. For decision-makers, this shift marks the end of silo-based innovation and the emergence of medicine driven by the complex organization of living organisms.
The adoption of bioconvergence responds to a triple imperative. Firstly, profitability, by reducing the R&D cycle. Secondly, sustainability, by minimizing the use of biological and animal resources. Finally, a public health imperative: by treating better and faster, we reduce the burden on health insurance systems.
3. Why India must champion animal-free drug testing
The arguments to end animal testing include ethical concerns, its poor predictive value, and a sense of its redundancy in the 21st century. India has already banned animal testing for cosmetics and introduced the New Drugs and Clinical Trials (Amendment) Rules, 2023, to further incorporate NAMs. With the release of the US FDA roadmap and the US National Institutes of Health’s plan to not fund studies based only on animals, India should consider such transformative shifts too.
India presents a favourable climate for NAMs with policies such as the Amendment to Clinical Trials and Drugs Rules, 2019 and revisions in the Guidance Document on Toxicology for Registration of Chemical Pesticides, and the presence of a growing number of laboratories in this field. However, to become a leader for humane technologies, India will need bold investments, global alliances, and strengthened participant engagement.
4. A landscape review of human relevant pre-clinical model development in the UK
UK scientists are developing advanced laboratory and computer models of human biology that could greatly reduce costs associated with failed clinical trials and accelerate the development of new medicines. However, at present, too many of these models fail to transition from university labs to commercial medicine development.
To address this issue, the Association of the British Pharmaceutical Industry (ABPI) and the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) have published a landmark review examining the UK’s capabilities in developing human-relevant pre-clinical models for medicine development. The review introduces a new Translational Readiness Framework to assess model readiness and identifies critical factors that must be addressed to turn cutting-edge academic science into scalable, industry-ready commercial tools for developing real-world treatments for patients.
INTERVIEWS, NOMINATIONS & AWARDS
5. Interview with Thermo Fisher Scientific: How science is taking a more human-relevant approach
Under the new US FDA policy, Investigational New Drug (IND) developers are now encouraged to include NAM-derived data, setting the stage for an unprecedented change in how preclinical safety and efficacy are evaluated. In a recent interview, John Bishop, director of project management, Research and Development, explained more about what’s driving the shift toward NAMs and how Thermo Fisher Scientific’s ongoing innovation in cell-based modeling and analysis tools will help enable its customers to leverage this evolving development and bring new therapies to market sooner.
“NAMs are not a short-term trend. I see this as a multi-year transformation. Momentum from regulators, pharmaceutical companies, and academia will continue to build, especially in preclinical research. The challenge will be in garnering a sufficient level of control over NAMs systems to consistently achieve the sufficient level accuracy and reproducibly to gain the trust of regulators.” John Bishop said.
TOOLS, PLATFORMS, CALLS
6. Launch of the Replacement of Animal-Derived Products in Life Sciences working group: ReALiSe
The 3Rs Centre Utrecht (3RCU) just announced the launch of its working group Replacement of Animal-Derived Products in Life Sciences (ReALiSe). Previously known as the Gels & Sera working group, ReALiSe has an expanded scope and audience. While the original focus was primarily on fetal calf serum (FCS) and basement membrane extracts (BMEs) such as Matrigel, the working group now addresses a broader range of animal-derived products (ADP) used in life science research.
With this broader scope, ReALiSe aims to support researchers at all stages of the replacement process — from early exploration of alternatives to implementation and validation in established workflows. ReALiSe is now open to researchers beyond ADP, and warmly welcome new members who are working on replacing ADP in their research or who are interested in learning more about available alternatives. Interested in joining the ReALiSe working group? Please contact 3RCU@uu.nl.
7. Neuro EDDU iPSC catalogue
The Early Drug Discovery Unit (EDDU) from the University of McGill (Canada) just released a catalogue of induced pluripotent stem cells (iPSCs) from healthy individuals and from patients with neurological disorders. It includes more than 180 patient‑derived and CRISPR‑edited lines from our broader library of 250, supporting research in neural and organoid systems.
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INDUSTRY, BIOTECH & PARTNERSHIPS
8. Big pharma’s China deal wave
In late January, AstraZenecaannounced a $15B investment in China through 2030, expanding R&D on Chinese soil with more manufacturing, and a focus on cell therapies and radioconjugates. The expansion builds on AstraZeneca’s long-running China footprint, which began in 1993 and currently runs two R&D centers in Shanghai and Beijing.
Speaking at the Asian Financial Forum in Hong Kong, executives from Merck and Amgen pointed to China as a likely early approval market for fully AI-designed drugs. Merck China president Marc Horn suggested that 2026 could mark the shift from AI-assisted discovery to compounds designed end-to-end by AI entering regulatory pipelines, citing China’s patient datasets, clinical execution, and the government’s recent “AI Plus” policy push. Amgen’s chief medical officer Paul Burton pointed to a similar timeline, seeing 2026 as a year when AI-driven and human genetics – led discovery could begin translating more directly into drug candidates.
9. Siemens Healthineers & Mayo Clinic partner on neurodegenerative disease and cancer
Siemens Healthineers and Mayo Clinic will expand a strategic collaboration aimed at improving diagnosis and treatment of neurodegenerative disease and cancer through new imaging, AI and interventional technologies.
In neurodegenerative disease, the collaboration includes work on AI-enabled magnetic resonance imaging (MRI) protocols for improved diagnostic accuracy and patient monitoring. For prostate cancer, the role of AI in minimizing biopsies will be investigated, along with integration of advanced imaging into diagnostic and therapeutic procedures. In liver cancer, efforts will focus on clinical translation of image-guided technologies for precise detection and treatment of metastases.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. QSP models to assess novel therapeutic peptide for neurological disorders
Blood – brain barrier (BBB) breakdown is a hallmark of several neurological disorders, including multiple sclerosis (MS). NX210c, a novel therapeutic peptide, has shown promise in restoring BBB integrity, in both preclinical and clinical settings, offering potential for use in MS populations and across various central nervous system conditions with overlapping mechanisms.
A new study evaluated the therapeutic potential of NX210c in MS patients using a previous quantitative systems pharmacology (QSP) model currently redesigned to capture the dynamic interplay between BBB integrity and immune system activity. Researchers validated the QSP model using both preclinical and clinical datasets, and generated virtual populations representing healthy individuals and patients for in silico testing. Their findings suggest that NX210c may enhance therapeutic efficacy in patients with relapsing – remitting MS by promoting BBB restoration and modulating immune responses, offering a promising avenue for combination treatment strategies.
11. Organizers in a dish: Modeling human brain morphogenesis
Brain organoids commonly recapitulate anterior regions of the human brain due to the propensity of neural progenitors to self-organize into cortical layers. In the embryo, posterior brain patterning is orchestrated by organizers, signaling centers positioned at anterior-posterior locations that are rarely induced in vitro. Thus, posterior models do not yet reproduce the morphological complexity of their in vivo counterparts.
In a new review, the authors discuss how this discrepancy may stem from the inability to recapitulate the spatiotemporal dynamics of organizer activity and how recent technologies can balance guided differentiation and self-organization, enhancing the fidelity of human brain organoid models.
Read the publication on Developmental Cell
12. Intelligent sensors for quality-assured cell production
Research scientists from the Fraunhofer Institutes for Biomedical Engineering (IBMT) and for Nondestructive Testing (IKTS) have jointly developed an intelligent sensor system that continuously monitors and optimizes the entire manufacturing process of 3D tissue models. Their solution enables continuous quality control in bioreactors and opens up new perspectives for the biotech and pharmaceutical industries – for more than just animal-free drug testing.
“Our [Multimodal Autonomous Sensor Platform] MAUS platform enables rapid prototyping for all monitoring applications. With its modular design, it can be adapted flexibly and expanded quickly and easily to meet any needs,” explains Christoph Weingard, sensor intelligence and microelectronics developer at Fraunhofer IKTS.
