News on non-animal methods
JANUARY 05 - 09, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. U.S. Senate passes FDA Modernization Act 3.0
Last December, U.S Senate Republicans and Democrats united to pass the FDA Modernization Act 3.0 (FDAMA 3.0), reaffirming strong bipartisan support for the government-wide shift toward modern, human-relevant technologies.
“With its April Roadmap and recent draft guidances, the FDA has acknowledged what decades of data have shown: traditional animal models often fail to predict human outcomes, while human-relevant technologies offer far greater accuracy,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy and Animal Wellness Action. “FDAMA 3.0 reinforces this scientific progress by aligning regulatory language with the agency’s modern practices. This is a pivotal moment — a transition toward a drug development ecosystem built on precision, efficiency, and meaningful benefits for patients.”
2. FDA qualifies first AI drug development tool
The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials.
The AIM-NASH system uses AI algorithms to analyze images of liver biopsies and provides scores according to the NASH Clinical Research Network scoring system. The process keeps humans involved, as pathologists are fully responsible for final interpretation, reviewing the whole slide image and AIM-NASH outputs before accepting or rejecting the AI-generated scores.
3. EU: Proposal for the European Biotech Act
Biotech can deliver ground-breaking medicines and treatments to patients, such as gene therapies and personalised medicine. It can also accelerate medical breakthroughs and help address unmet medical needs.
On December 16th, the Commission adopted a proposal for a Biotech Act. Seeking to enhance access to funding and priority support mechanisms, it also proposes to revise EU rules on clinical trials, advanced therapy medicinal products, substances of human origin, human organs and genetically modified organisms, with the aim to strengthen health biotech in the EU and help the EU close innovation gaps with global competitors.
4. New WHO guidelines on non-animal tests for quality control of biologics
The NC3Rs was commissioned by the World Health Organization (WHO) – the gatekeeper for global standards for vaccine and biologics safety – in 2019 to audit its guidelines for batch release testing, an area that is estimated to use around 10 million animals a year in tests that can involve significant suffering.
In direct response to NC3Rs recommendations, WHO developed new guidelines that encourage manufacturers and regulators to replace or remove animal-based quality control methods. The new guidelines establish a clear international mandate to transition away from animal models for quality control testing and suggest specific non-animal test types and products in line with our recommendations. This includes replacing both the rabbit pyrogen test and adventitious agent testing in animals, aligning with ambitions in the UK government’s alternatives strategy.
5. NCI advisory board must prioritize human-relevant methods
Cancer remains the second leading cause of death in the U.S.. A key driver of this persistent burden is continued use of animals in attempts to study cancer and develop treatments. Profound genetic, molecular, immunological, and cellular differences between humans and mice prevent animal experiments from accurately identifying effective cancer therapies.
Dr Gabby Vidaurre, Research Associate at Science Advancement and Outreach (PETA) submitted a public letter to the U.S National Cancer Institute (NCI) advisory board (NCAB) to align its research and training priorities with NIH’s April 2025 commitment to prioritize non-animal methods (NAMs).
6. PARC: New strategic projects to strengthen regulatory chemical risk assessment
Starting in May 2026, PARC will initiate a new portfolio of strategic projects. These initiatives aim to further advance chemical risk assessment in Europe by integrating new approach methodologies (NAMs), developing advanced toxicological and exposure models, and strengthening the scientific basis for European regulatory decision-making.
Together, these projects reflect PARC’s growing focus on regulatory readiness and implementation, supporting key European policy frameworks, including the European Green Deal, the Chemicals Strategy for Sustainability, and the One Substance, One Assessment (OSOA) legislative package, supported by PARC. By addressing complex and emerging risks across human health and the environment, the projects contribute to safer, more sustainable chemical management in Europe.
INTERVIEWS, NOMINATIONS & AWARDS
7. NWO grants
Perspectief grant
The Dutch Research Council (NWO) has awarded a €7.2 million Perspectief grant to the consortium Scalable Personalized Nano-Therapeutics for Cancer Treatment (SPARC), that aims to overcome one of the major challenges in oncology: how to personalise nano-therapeutics at scale, while ensuring quality, safety and cost-effectiveness. SPARC addresses these challenges through personalized nano-therapeutic design and Tumor-on-a-chip testing for human-relevant prediction and scalability.
No fewer than twelve consortia will be able to start their research projects aimed at developing technological innovations thanks to the Perspective program. Another will contribute to the transition to animal-free innovations: the FEMCHIP project focuses on improved diagnosis and treatment of endometriosis and adenomyosis using human in vitro models.
Vidi grant
The Vidi grant, part of NWO’s Talent Programme, is a personal award designed to support experienced researchers in initiating or expanding an independent line of research. Dr. Mani Diba received a Vidi grant (€1.25 M) from the NWO for the DYNAVIVO projectto expand expertise in dynamic biomaterials and bone-on-chip systems to develop a new in vitro platform with real-time control over cellular confinement.
TOOLS, PLATFORMS, CALLS
8. NIH research priority areas for new potential funding topics
Consider the National Institute of Health (NIH) centralized list of highlighted topics for your next investigator-initiated grant application. Each topic represents a selected research priority area within one or more NIH Institutes, Centers, or Offices (ICOs) that may or may not have dedicated funding.
Some key topics applicable for NAMs scientists: Advancing the Use of 3D Technologies Using Human Auditory, Vestibular and Chemosensory Organoids to Create New Approach Models (NAMs) for Treatments, Leveraging New Approach Methodologies and Non-Animal Technologies to Accelerate Osteoarthritis Research, BRAIN Initiative: Data Knowledgebase Ecosystem and NeuroAI Integration.
9. EUROoCS Annual Meeting: Call for abstract
The next EUROoCS Annual Meeting (22 – 24 June 2026) will bring together leading experts from academia, clinical research, industry, regulatory agencies, and policymakers to explore the latest breakthroughs in organs-on-chip and microphysiological systems (MPS). Over two and a half days, the conference will feature plenary and keynote lectures, scientific sessions, poster presentations, and industry showcases, providing ample opportunities for interdisciplinary networking and exchange.
Topics will include disease and multi-organ models, organ-on-chip, PK/PD modelling, biofabrication and biomaterials, standardization and toxicity, among others. Abstract call is now open and will close on February 2nd.
Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
10. Lab Automation: Where Discovery Scales
Automation now plays a central role in discovery. From self-driving laboratories to real-time bioprocessing, a new report published by Drug Target Review explores how data-driven systems improve reproducibility, speed decisions and make scale achievable across research and development.
Discover how leading scientists and organisations are using automation to accelerate discovery. The report explores scalable assay development, automated 3D systems, self-driving laboratories and real-time bioprocessing. It shows how these advances improve reproducibility, strengthen data quality and make scale achievable across research and manufacturing.
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Emulate Top 10 Organ-Chip Publications of 2025
If regulatory momentum helped define 2025 as a pivotal year for New Approach Methodologies (NAMs), industry adoption helped reinforce their value. A year-end series highlighting the Top 10 scientific papers of 2025 using Emulate Organ-on-a-Chip (OOC) technology.
The Top 10: Assessment of drug permeability using Airway Lung-Chip, Stable rat and dog liver chips, OOC model of osteolytic bone metastasis, Patient-specific colorectal cancer (CRC) OOC model, Physiological crosstalk within the female reproductive tract, Intestinal epithelial OOC vs organoid and transwell model, OOC patient model of sporadic ALS, Duodenum Intestine-Chip with in silico PBPK modeling, Esophageal adenocarcinoma (EAC) OOC model, Porcine intestine OOC model.
12. Multimodal AI generates virtual population for tumor microenvironment modeling
The tumor immune microenvironment (TIME) critically impacts cancer progression and immunotherapy response. Multiplex immunofluorescence (mIF) is a powerful imaging modality for deciphering TIME, but its applicability is limited by high cost and low throughput.
A new publication in Cell proposes GigaTIME, a multimodal AI framework for population-scale TIME modeling by bridging cell morphology and states. GigaTIME learns a cross-modal translator to generate virtual mIF images from hematoxylin and eosin (H&E) slides by training on 40 million cells with paired H&E and mIF data across 21 proteins. Such studies were previously infeasible due to the scarcity of mIF data. By translating readily available H&E pathology slides into high-resolution virtual mIF data, GigaTIME provides a novel research framework for exploring precision immuno-oncology through population-scale TIME analysis and discovery.
13. Mechanistic read-across comes of age: A comparative appraisal
Read-across has matured from an expert-driven extrapolation based largely on structural analogy into a rigorously documented, mechanistically informed cornerstone of next-generation risk assessment. In a new report published by Prof Thomas Hartung and Dr Costanza Rovida, three pivotal frameworks are compared: the European Food Safety Authority’s (EFSA) 2025 guidance for food and feed safety, the European Chemicals Agency’s (ECHA) Read-Across Assessment Framework (RAAF) for industrial chemicals under REACH, and the community-driven Good Read-Across Practice (GRAP) principles.
Using five analytical lenses — conceptual structure, scientific rigor, implementation tools, regulatory acceptance, and practical impact — the authors identified areas of complementarity and divergence. Globally, the convergence of these frameworks — reinforced by OECD initiatives and NAM-enhanced case studies — signals an emerging international consensus on what constitutes defensible read-across.
