News on non-animal methods
APRIL 20 - 24, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. The Merck “3 Baskets” approach for creating roadmaps to phase out animal testing
In ALTEX latest issue, Kerstin Kleinschmidt-Doerr et al. describe their Merck KGaA 3 Baskets (3B) strategy, introduced in 2021, to reduce animal testing by 50% by 2032 and by 75% by 2040 through a 4R program (Replace, Reduce, Refine, Responsibility).
The approach focuses on what they can achieve today and avoids obstructive discussions about unresolved issues. This strategy guides effective short-term replacement and directs investments into areas where innovation can replace animal testing in the future. It coordinates the way forward for all stakeholders and creates actionable milestones toward a genuine replacement of animal testing. The collaborative agreement in 2024 among the members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) to adopt the 3B approach, recognized by the European Commission and the European Medicines Agency (EMA), highlights its significance as a valuable tool for fostering a more ethical and sustainable science environment across Europe.
2. Mapping 3Rs and NAM projects funded through European framework programmes since 2007
The development of New Approach Methodologies (NAMs) is increasingly enabling the replacement and reduction of animal use in research. The European Commission has supported these approaches by embedding 3R requirements in policy frameworks and providing dedicated funding for 3Rs/NAMs-related research. However, a systematic and comprehensive overview on European Union (EU) research funding of these projects is lacking.
In a recent study conducted by Mathieu Vinken, jointly prepared with Julia Matyjasiak and Alexandra Costina Avîrvarei, projects funded under Framework Programme 7 (2007 – 2013), Horizon 2020 (2014 – 2020) and Horizon Europe (2021 – 2027, extracted until March 2025) were analysed using the EU Community Research and Development Information Service database (CORDIS). Approximately 40% of these projects were toxicology-related, while the remainder pertained to areas such as disease research or technology scaling, with oncology and neuroscience emerging as major application areas.
3. New Future Market Insights report on the microfluidic OOC drug testing market
The global microfluidic organ-on-chip (OOC) drug testing market is entering a rapid growth phase as pharmaceutical and biotechnology companies transition from traditional animal and static cell-based assays to dynamic, human-relevant predictive models.
Valued at USD 141.5 million in 2025, the market is projected to reach USD 168.0 million in 2026 and surge to USD 932.9 million by 2036, expanding at a robust CAGR of 18.7% during the forecast period. According to Future Market Insights (FMI), this growth is being driven by the urgent need to reduce late-stage clinical failures, evolving regulatory acceptance of non-animal testing data, and the increasing complexity of biologics that require more physiologically relevant preclinical models.
Read more & download the report
Read the short analysis by Sam Llyod-Burton, Director of Product Management at STEMCELL Technologies
4. Reimagining human-centric drug development with NAMs
Despite unprecedented technological progress, most drug candidates continue to fail in clinical trials, reflecting a persistent gap between preclinical models and human biology. NAMs, by spanning human-derived cellular systems, microphysiological platforms, and artificial intelligence, offer a paradigm shift in human-centric drug development and biomedical research.
Recent regulatory reforms, such as the US Food and Drug Administration (FDA) Modernization Act 3.0, have begun to position NAMs as a complement to or replacement for animal testing. A new review synthesizes emerging biological and computational NAMs and examines how their integration is reshaping drug development. The authors also discuss regulatory and ethical frameworks enabling this transition and outline a roadmap for embedding NAMs in a predictive, efficient, and ethically grounded infrastructure of human-centered drug development.
Read the full article in Science
INTERVIEWS, NOMINATIONS & AWARDS
5. Joseph C. Wu: Recipient of the 2026 Stanley J. Korsmeyer Award
The Stanley J. Korsmeyer award from the American Society for Clinical Investigation recognizes the outstanding achievements of its members in advancing knowledge in a specific field and in mentoring future generations of life science researchers. Joseph C. Wu, Director of the Stanford Cardiovascular Institute and the Simon H. Stertzer, MD, Professor of Medicine and Radiology, is the recipient of the annual Award and is provided with a $20,000 honorarium.
For his Korsmeyer Award Lecture, Joseph C. Wu focused on “Genomics, AI, and NAMs for Drug Discovery” and covered the past 20 years of research in which he has advocated for the concept of “clinical trial in-a-dish” (CTiD) using human induced pluripotent stem cells (iPSCs) as patient’s “biological twin”.
TOOLS, PLATFORMS, CALLS
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INDUSTRY, BIOTECH & PARTNERSHIPS
6. Anivance AI’s inhalation-focused MPS platform selected by the FNIH NAMs pilot initiative
In our weekly NAMs news / 23 – 27 Feb. 2026, we shared that the Foundation for the NIH (FNIH) selected four innovative, human-based research platforms for development into pilot projects to help advance NAMs through the Validation and Qualification Network. Since then, the FNIH has assembled project development teams — including key public and private partners from government, academia, life sciences companies, and others — to validate each platform.
Anivance AI, a Taiwanese start-up, has been selected by the FNIH to participate in the Inhalation Toxicity pilot. Founded by Guan-Yu Chen, Ph.D, Anivance AI is a member of Pro Anima scientific Committee and develops AI-powered organ-on-chip technology with automated, high-throughput workflows, creating a new era of intelligent drug discovery. Anivance AI’s inhalation-focused MPS platform aims at advancing human-relevant testing methods through structured validation pathways toward regulatory acceptance. Moving inhalation models into qualification frameworks represents an important step in modernizing safety assessment.
7. Dynamic42 and EPO close the gap in brain cancer research
One of the key challenges in brain cancer research is the limited availability of preclinical models. Dynamic42 GmbH, based in Jena, Germany, and EPO Experimental Pharmacology & Oncology Berlin-Buch GmbH are addressing this gap through a new strategic collaboration that brings organ-on-chip technologies closer to the core of preclinical drug development.
The first joint projects target glioblastoma and the blood – brain barrier (BBB). “For us, this collaboration is about strengthening the translational link,” declared Jens Hoffmann, CEO at EPO. “Integrating advanced in vitro systems allows us to look at tumor biology from a different angle and to build robust experimental in vivo strategies.”
8. TARIO‑2: A whole-transcriptome foundation model from H&E alone
Spatial transcriptomics (SpT) may be the richest measurement of a tumor we have. However, it is also almost never collected. TARIO‑2 is a new foundation model built by Noetik, a biotech company, to exploit this fact. It extends the TARIO architecture to multimodal sequences of H&E (hematoxylin and eosin) and SpT tokens. TARIO‑2 requires only an H&E image as input, turning a simple pathology slide into a high-dimensional molecular readout, enabling scalable and cost-efficient analysis of tumor biology.
Early results show that the model can recover meaningful gene expression patterns and even predict clinically relevant features such as tumor type, genetic mutations, and potential treatment response. More broadly, Noetik positions TARIO‑2 as a step toward “foundation models” in biology — systems that learn underlying biological patterns at scale and could eventually power more personalized and data-driven cancer care.
9. OpenAI Foundation’s Alzheimer’s research initiative
Alzheimer’s disease is one of the hardest unsolved problems in medicine. Alzheimer’s does not appear to be driven by a single cause, but by the interplay of genetic risk factors, protein misfolding, inflammation, synaptic dysfunction, and more — interacting with environmental factors over decades and all unfolding in the brain, an organ that’s hard to study and deliver drugs to. Traditional research approaches have struggled to make sense of this.
AI is uniquely suited to confront this complexity in reasoning across different types of data — including patient clinical symptoms, biological markers of disease, screens of drug candidates, and more — offers a fundamentally new way to understand how these factors interact, identify appropriate drug targets, and diagnose actionable risks decades earlier for patients. The OpenAI Foundation’s Alzheimer’s research initiative is working to finalise more than $100 million in grants this April, across six research institutions, to support and accelerate Alzheimer’s research — generating new data, helping design new drugs, and expanding possible paths to treatment.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. T‑World: New computational model of human ventricular myocyte
Mechanistic cardiac simulations are increasingly used in research, pharmaceutical development, and regulatory science. A recently developed model, named T‑World, overcomes the barrier of most existing human cardiomyocyte models by reproducing all major cellular arrhythmia mechanisms and showing comprehensive agreement with experimental and clinical data.In two articles, Jakub Tomek et al. aimed to demonstrate the utility of T‑World for organ-level and translational research, from ionic mechanisms of arrhythmogenesis to emergent whole-heart physiology.
The research comes as two back-to-back papers in Circulation Research. The first paper describes the development and validation of T‑World. The second paper focuses on applications, such as drug studies with relevance to the pharmaceutical industry, disease modelling, and organ-scale simulations of arrhythmia and contraction. T‑World is open source, distributed as Matlab and CellML code. Online GUI is also available to run the model without coding.
Read the first paper in Circulation Research
Read the second paper in Circulation research
11. Towards learning and memory risk assessment with human brain organoids: Barriers and opportunities
The emerging field of “organoid intelligence” integrates human brain organoids (hBOs) systems with advanced bioengineering and artificial intelligence to model higher-order neural functions and assess learning and memory-relevant endpoints that were previously less explored in vitro.
Despite this promise, researchers from Johns Hopkins Bloomberg School of Public Health have identified four key barriers that hinder the application of hBOs for the hazard identification phase of functional neurotoxic risk assessments: limited maturity and regional complexity; lack of high-throughput defined procedures for assessing cognitive development and function in vitro; limited standardization for reproducibility; and challenges in translating in vitro results to human health outcomes.
Read more in Frontiers in Toxicology
Read more about brain organoids in Nature: “Mini models of the human brain are revealing how this complex organ takes shape”
12. Towards autonomous mechanistic reasoning in virtual cells
Large language models (LLMs) have recently gained significant attention as a promising approach to accelerate scientific discovery. However, their application in open-ended scientific domains such as biology remains limited, primarily due to the lack of factually grounded and actionable explanations.
To address this, researchers introduced in a preprint article a structured explanation formalism for virtual cells that represents biological reasoning as mechanistic action graphs, enabling systematic verification and falsification. Building upon this, they propose VCR-Agent, a multi-agent framework that integrates biologically grounded knowledge retrieval with a verifier-based filtering approach to generate and validate mechanistic reasoning autonomously. Using this framework, they released the VC-TRACES dataset, which consists of verified mechanistic explanations derived from the Tahoe-100M atlas.
13. Development of autologous in vitro vascular models for use in preclinical biotherapeutic process
Traditional in vitro cytokine release assays do not accurately recapitulate in vivo blood vessel physiology. Including endothelial cells improves physiological relevance by representing the internal vascular wall, enabling cell-cell interactions, compound presentation, and cellular responses from endothelial cells alongside blood cells.
Researchers established a new vascular model using whole blood transferred into a 3D microfluidics system, further mimicking the dynamics and structural microenvironment of a blood vessel. They used these human vasculature models to recapitulate the expected cytokine response to existing compounds and highlight the additional preclinical safety end points that can be investigated by using a 3D vessel, such as vascular leak. This proof-of-concept study demonstrates foundations for a scalable, physiologically relevant method for preclinical testing while reducing reliance on animal models.
WORTH (RE)SHARING
3D human liver reconstruction reveals changes in cirrhosis
Integral Molecular breaks down the limitations of TCR (Tissue Cross-Reactivity) and examines why toxicologists don’t trust the data
ALTEX latest issue (Vol. 43 No. 2 — 2026):
- Thomas Hartung.: “Pyrogen testing at a turning point – On occasion of the 30th anniversary of the whole blood monocyte activation test”
- Bokara Kiran Kumar et al.: “Advancing humane and human-relevant science: The 8th Annual Conference of the Society for Alternatives to Animal Experiments – India (SAAE‑I 2025)”
European Parliament’s Committees:
- ENVI (Environment, Public Health and Food Safety Committee) on ECHA: ENVI Members voted on the adoption of the draft report on the Regulation on the European Chemicals Agency
- ENVI on Chemical Omnibus: ENVI and IMCO Members voted on the adoption of the joint draft report on simplification of certain requirements and procedures for chemical products
- SANT (Public Health Committee) meeting on MDR and IVDR: Presentation of the proposal for a regulation amending MDR and IVDR by Olivér Várhelyi, Commissioner for Health and Animal Welfare
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Next session of the SCAHT AOP_HUB Webinar Series II: AOP From Principles to Practice
- 12 May, Nina Jeliazkova, AOP Mapper, 12:00 to 13:00 CEST
- 26 May, Barry Hardy and Asmaa Ali, AOP GraphExplorer, 12:00 to 13:00 CEST
