News on non-animal methods
MARCH 23 - 27, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. FDA: General considerations for the use of NAMs in drug development
The Food and Drug Administration (FDA) announced the availability of a draft guidance for industry. The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using New Approach Methodologies (NAMs) in drug development.
Finding ways to improve human relevance while reducing the use of animals by developing reliable NAMs furthers an important Center for Drug Evaluation and Research (CDER) priority to move away from reliance on animal testing. This draft guidance is not intended to address specific NAMs and does not address the use of NAMs in drug discovery; rather, it encourages the use of NAMs in regulatory submissions, especially when they improve the predictivity of nonclinical studies for increased safety in clinical trials.
The draft is open for public comment.
2. NIH invests $150 million in human-based research to reduce use of animal models
The National Institutes of Health (NIH) announced more than $150 million to develop and scale research methods that better simulate human biology and reduce reliance on animal models. The funding marks the first awards under the Complement Animal Research in Experimentation (Complement-ARIE) program (see news 7).
The program will establish technology development centers (TDCs) to facilitate NAM development in the areas of greatest scientific and regulatory need. A NAMs data hub and coordinating center (NDHCC) will facilitate data sharing and standards development, while a Validation and Qualification Network (VQN) will leverage a public-private partnership with industry and regulatory expertise necessary to implement reliable, marketable NAMs. “This is an exciting opportunity to create a repertoire of human-focused methods that are so sophisticated and comprehensive that successful clinical translation will rise and we will be able to answer questions beyond our reach with current research models,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives.
Read more on the funding breakdown and patterns by Sam Lloyd-Burton
3. Swiss 3RCC new report: Global initiatives to replace and reduce animal use
Focusing on legally binding measures and regulatory-driven actions, the Swiss 3RCC report maps developments across sectors such as cosmetics testing, chemical safety and biomedical research. It highlights policy shifts led by governments, international bodies and private actors that are influencing legislation, regulatory frameworks and official strategies worldwide.
Over the past decade, significant momentum has emerged across multiple regions, including the European Union, the United States and China, toward the adoption of non-animal methods. This report aims to provide a factual, comparative foundation for understanding how alternative methods are being embedded into policy and practice globally. A forthcoming complementary report will explore funding mechanisms, research programmes and institutional support systems that facilitate the development and implementation of alternative approaches.
Read more and download the report
4. NAMs in France and Europe: The current landscape
In a recent guest article, Lilas Courtot, Ph.D, Scientific manager, and Emeline Gougeon, Strategy development head, of Pro Anima Scientific Committee, explored the growing importance of NAMs in France and across Europe as part of a broader shift toward more human-relevant, non-animal-based approaches in drug development.
The authors also addressed the remaining barriers in the uptake of NAMs, hindered by fragmentation across national initiatives, limited standardization, and uncertainties around regulatory acceptance.
Read more on Drug Discovery Online
5. South Korea: New legal category of ‘advanced regenerative medicine treatment’ — Comparative lessons from Japan
In South Korea, the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products was enacted in 2019 to promote access to advanced regenerative therapies under centralized governmental oversight. However, the original framework was limited to clinical research, resulting in limited implementation. To improve patient and developer access, the law was amended to introduce a new legal category, Advanced Regenerative Medicine treatment (ARMT), which allows investigational regenerative medicine to be provided in clinical practice at approved institutions, with patients being charged.
A recent study examines the newly implemented ARMT framework in Korea and analyzes its regulatory design and anticipated implications, drawing comparative lessons from Japan’s experience under the ASRM for the sustainable and responsible integration.
6. A roadmap for better antibodies in research
The roadmap developed by the Only Good Antibodies (OGA) initiative aims to tackle the well-documented reproducibility crisis in antibody-based research by promoting the systematic identification, validation, and dissemination of high-quality antibodies. It emphasizes the need to shift from poorly characterized reagents toward rigorously validated antibodies supported by open, community-driven datasets (notably through collaboration with initiatives such as YCharOS).
The plan highlights key challenges, and outlines a coordinated strategy structured around data generation, standardization, and community engagement. Ultimately, the roadmap envisions a cultural and methodological shift toward transparency, collaboration, and evidence-based reagent selection, with the goal of improving research reliability, accelerating discovery, and enhancing downstream clinical and diagnostic outcomes.
INTERVIEWS, NOMINATIONS & AWARDS
7. Johns Hopkins researchers awarded $15 million to develop platform to study neurological diseases and screen chemicals using NAM
A team of Johns Hopkins researchers has been awarded a five-year $15 million grant from the NIH (see News 2 above) to develop a platform to test potential new treatments for neurological diseases such as Alzheimer’s, and to screen for harmful chemicals. The Drug Research Organoid Intelligence Development Platform (DROIDp) will use brain organoids — lab-grown neural tissues derived from human stem cells — advanced electrical sensors, and AI analytics to assess neural functions such as learning and memory in drug and chemical testing, and to develop integrated NAMs.
“Through the NIH Common Fund’s Complement-ARIE program, we have an opportunity to develop integrated NAMs into a practical framework that can reduce reliance on animal studies” says Lena Smirnova, PhD, assistant professor in the Department of Environmental Health and Engineering and program lead at the Center for Alternatives to Animal Testing at the Johns Hopkins Bloomberg School of Public Health and co-leader of the project.
8. Clémence Deligne: winner of the FC3R 2025 3R “Research” Prize
The 3R French Center, FC3R, awarded the 2025 “Research” Prize to Clémence Deligne, a postdoctoral researcher at the Cancer Research Centre of Lyon (CRCL), on the site of the Centre Léon Bérard, in the “Cellular States and Childhood Cancers” team co-directed by Dr. Marie Castets and Professor Jean-Yves Blay. This distinction recognizes her publication on the development of a biobank of patient-derived organoids for the study and treatment of pediatric brain cancers.
“Clinical relevance is an essential criterion for models used in translational research, in order to generate robust and transferable results from bench to bedside. In our study, we established tumoroid models before and after chemotherapy in two patients. We then exposed these tumoroids to the same treatment received by the patients and observed an in vitro response that replicated the clinical response. We were thus able to demonstrate the predictive potential and therefore clinical relevance of our models, which is a major strength of our study and opens up possibilities for personalized medicine” said Clémence Deligne.
Read the interview (FR)
TOOLS, PLATFORMS, CALLS
9. PEPPER call for partner laboratories for TPO-catalyzed iodination assay
PEPPER, the public-private platform for the validation of endocrine disruptors characterization methods, launched the call for “testing laboratories” for the validation of a new method “TPO-catalyzed iodination assay”.
Thyroid peroxidase (TPO) is an enzyme located on the apical membrane of thyroid follicular cells. It catalyses the oxidation of iodide using hydrogen peroxide (H₂O₂) and enables the iodination of tyrosyl residues in thyroglobulin (Tg). Certain chemicals can interfere with TPO activity and thereby disrupt thyroid hormone synthesis. The TPO‑catalysed iodination assay aims to identify such interference using a biochemical system derived from a human thyroid cell line.
To apply, send your offer no later than the 10th of April, following the instructions to tender@ed-pepper.eu
Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
10. Tecan aims to bring unused lab data to life with NVIDIA
The Tecan Group announced a strategic collaboration with NVIDIA focused on providing the AI-enabled platforms that data-driven Laboratories need to achieve faster discoveries and higher lab productivity. Having led the first lab revolution, Tecan continues to push lab automation by launching modern lab productivity products, such as Introspect, the lab analytics platform.
The collaboration represents an exciting opportunity as a significant amount of the lab-generated data is not fully utilized. Through the collaboration between NVIDIA and Tecan, the companies aim to ignite the next lab revolution, using AI and this yet unmapped data landscape to enable breakthrough discoveries and unprecedented productivity gains.
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Cellular snowballing: Cell adhesion and migration drive the self-assembly of cell-microgel biohybrid spheroids
Creating 3D tissue models using cell spheroids that recapitulate the complicated structures and functions of human tissues is essential for advancing NAMs used in drug testing/screening, disease modeling, and regenerative medicine. However, cell spheroids often have dense cellular structures and subsequently poor cell survival, primarily due to impaired oxygen and metabolite transport.
To overcome these limitations, Amir Sheikhi, Associate Professor and Dorothy Foehr Huck and J. Lloyd Huck Early Career Chair in Biomaterials and Regenerative Engineering (Pennsylvania State University) and Zaman Ataie, PhD in Chemical Engineering, Senior Scientist at Merck VDPD, with a team of researchers developed biohybrid spheroids (BHS), self-assembled living-synthetic hybrid aggregates, using adherent cells as assembly engines and hydrogel microparticles (microgels) as extracellular matrix-mimetic substrates. An agent-based model was also developed to recapitulate the snowballing assembly in a geometrically unconstrained environment, providing fundamental insights into the assembly kinetics and the ultimate BHS size and pore features.
Read the study in Advanced Science
12. Endometrioids: 3D in vitro model for studying human implantation and implantation failure
A better understanding of human embryo implantation is essential for improving assisted reproduction outcomes and addressing recurrent implantation failure (RIF). However, ethical constraints and limited access to human embryos make direct studies challenging. To overcome this, researchers developed a 3D in-chip implantation model using human blastoids or blastocysts co-cultured with a bioengineered human endometrial tissue, termed endometrioid.
The system successfully recapitulates key events of human implantation and early post-implantation development. This 3D platform enables mechanistic investigation of human implantation and implantation failure and offers a scalable approach to evaluate therapeutic strategies for improving embryo-endometrium interaction in a clinical setting.
WORTH (RE)SHARING
EMA: New PRIME tools to accelerate development of medicines in the EU
The European Commission postpones European Innovation Act
Preprint on bioRxiv: 1st comprehensive multi-modal benchmark of Ultima UG100 vs Illumina NovaSeq on FFPE tissues
3Rs Centre Utrecht is looking for an enthusiastic student assistant to help update the Fetal Calf Serum (FCS)-free database. More info and apply
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
EMA’s 3Rs Working Party annual stakeholder meeting with the presentation of its workplan for 2026 – 2028. Virtual public session: 31 March 2026, 09:30 – 10:30 (CET). No prior registration required.
Webinar: BrainXell — Human iPSC-Derived Sensory Neurons for Functional Sensory Biology and Pharmacology Research. 02 April 2026, 5:00 pm (CET), online.
