NAMs News
SEPTEMBER 21 - 25, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. FDA updates regulations and share resources to advance NAMs
On September 21, the Food and Drug Administration (FDA) issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they are tried in humans, reflecting advances in science and technology that have expanded the range of testing options available in human drug development, including methods using human cells, organs-on-chips, computer models and other advanced technologies.
The FDA also produced resources:
- New Approach Methodologies (NAMs) database of Use Case Examples – publicly available FDA application review materials, organized around the method, so users can search for a NAM and then examine applications in which it appeared. Users may also reference the Collection of Alternative Methods for Regulatory Application (CAMERA) database, which describes these and other NAMs in further detail, and the CDER Streamlined Nonclinical Studies and Acceptable NAMs webpage.
- Phase 1 Investigational New Drug (IND) Navigator – provides the tools, guidances, and regulatory expertise to prepare and submit an Investigational New Drug application (IND) to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
Read more on the regulations update
2. NIH: Major investments to advance human-based research and sex-specific hormonal biology
The National Institutes of Health (NIH) is making its biggest push yet to move biomedical research beyond animal model use investing $88 million in funding for biomedical infrastructure projects nationwide; a new challenge offering over $7 million in awards to demonstrate how quantum-enabled approaches can improve detection and measurement in lab-based NAMs.
In addition, NIH launches a $21 million initiative to improve understanding of sex-specific hormonal biology. The program, known as the Computational Modeling of Hormone Homeostasis Initiative, will advance novel human-based, data-driven models tailored to a man or a woman’s complex physiology through advanced computational techniques.
Read more on the human-based research investment
Read more on the sex-specific hormonal biology
3. From vivarium to NAM-centred laboratory: A practical framework for managing infrastructure, expertise and organisational transition
The growing adoption of NAMs is being driven by scientific advances, regulatory changes, and the need for more human-predictive approaches. As animal testing is increasingly phased down, universities, pharmaceutical companies, and contract research organisations face the challenge of adapting existing facilities, equipment, investments, and specialised workforces to new testing strategies.
A new research article proposes a practical framework for managing this transition, focusing on infrastructure redevelopment, workforce retraining, business sustainability, and preservation of scientific and technical expertise. Tools such as Contexts of Use (CoUs) and Adverse Outcome Pathways (AOPs) can help connect knowledge from historical animal studies with emerging NAM applications.
4. The invisible animal use: How to make in vitro research truly animal-free
Research described as in vitro is not always completely animal-free, as common materials such as fetal bovine serum, animal-derived antibodies, and basement membrane extracts can involve animals that are not captured in reported experimental use. Although animal-free alternatives exist, their adoption remains limited because researchers often lack comparative evidence showing that these alternatives will perform reliably in their specific experimental systems.
The NC3Rs and the 3Rs Center Utrecht (3RCU) have addressed this evidence gap by funding research to validate animal-free reagents, including recombinant antibodies, chemically defined media, and synthetic matrices. A 2024 investment of £905,000 supported ten projects involving 18 academic and industry partners, generating performance data for more than 200 animal-free reagents and model components. The programme is expected to enable the replacement of thousands of animals annually and has already attracted substantial follow-on funding.
INTERVIEWS, NOMINATIONS & AWARDS
5. Minds behind Organ-On-Chip – by Dynamic42
The german company Dynamic42 is running its season 2 of the “Mind behind Organ-On-Chip” video interview series, spotlighting researchers advancing MPS and organ-on-chip technologies.
In a latest video, they talked to Adrian Feile from the Mosig Group at Universitätsklinikum Jena. Adrian showed us how DPO (3,5‑dimethylpyrazin-2-ol)-dependent quorum sensing modulates the biofilm behavior of Vibrio cholerae in an intestine-on-chip infection model.
TOOLS, PLATFORMS, CALLS
6. STEP4NAMS: From NAM Training to Hands-On Application
STEP4NAMs helps BioPharma, MedTech, and SME teams move from learning about NAMs to applying them in R&D. Its EDUCATE programme provides online training on NAM fundamentals, applications, and regulatory considerations, followed by specialised modules on specific technologies.
Upcoming hands-on training includes:
- Benchtop simulation for medical device testing in Galway, Ireland, on 26 November 2026
- Organ-on-Chip training in Tübingen, Germany, from 25 – 27 January 2027
The sessions offer practical experience with vascular and device simulations, as well as organ-on-chip fabrication, cell culture, perfusion, imaging, analysis, and modelling.
7. Respiratory sensitisation: OECD is welcoming data from developers regarding test methods relevant for inclusion in the future IATA
The International Council on Animal Protection in OECD Programmes (ICAPO) and the US are leading an OECD Expert Group developing an Integrated Approach to Testing and Assessment (IATA) for Respiratory Sensitisation.
They are welcoming submission of any additional nonanimal methods for respiratory sensitisation that are not included in the recent OECD publication. The deadline to submit is October 8, 2026.
INDUSTRY, BIOTECH & PARTNERSHIPS
8. CTIBIOTECH invests €3M and secures €1.25M from France 2030 to revolutionize personalized cancer care
CTIBIOTECH™, an innovative French Contract Research, Development, and Manufacturing Organization (CRDMO) based in Meyzieu-Lyon, proudly announces the launch of the CTIONCOTEST™ project, a groundbreaking €3 million initiative aimed at transforming preclinical cancer research.
To accelerate this critical innovation, CTIBIOTECH ™ has been awarded €1.25 million in funding from Bpifrance under the “Aide au Développement Deeptech” program, with the strategic support of France 2030 and the Government of France. Professor Colin McGuckin, President and Chief Scientific Officer of CTIBIOTECH shared his pride and vision “The industrialization of the CTIONCOTEST platform marks a crucial step toward personalized medicine against cancer, where treatments can be individually tailored to a patient’s specific tumor profile”.
9. Drug discovery in metabolic diseases: Revvity to acquire France-based biotechnology company
Revvity, Inc. announced it has entered into a definitive agreement to acquire Human Cell Design (HCD), a France-based biotechnology company specializing in human cell models and preclinical research solutions for diabetes, obesity and other metabolic diseases.
The acquisition is expected to add HCD’s human pancreatic beta cell models to Revvity’s Life Sciences portfolio, supporting drug discovery, screening and preclinical research, including applications in GLP‑1 and other metabolic disease therapies. “Joining Revvity is expected to allow us to bring our human cell models and NatLine technology to a broader global customer base while supporting the development of new physiologically relevant cell models” said Guillaume Costecalde, founder and president of HCD.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. An in vitro human cell – based test method to assess two surfactants’ point-of-contact respiratory tissue irritation
A new paper in Toxicological Sciences shows that human cell – based in vitro models can be used to assess respiratory tissue irritation caused by chemicals. Researchers from PETA Science Consortium International, the US EPA (United States Environmental Protection Agency), and VITO tested two surfactants using human bronchial cells and a reconstructed human respiratory tissue model called MucilAir. The results indicate that these models can predict respiratory effects and could potentially be applied to other chemicals.
The research has also helped shape EPA guidance that prioritizes human cell – based data for regulatory decisions on surfactants. The same method is being evaluated in a multi-laboratory study involving about 20 additional chemicals, with the project accepted into the OECD Test Guidelines Programme in August 2026. If successfully validated, the method could eventually become an OECD Test Guideline, providing a human-relevant approach that avoids relying on animal-to-human extrapolation.
Read the publication in Toxicological Sciences
11. More than 1,000 overlooked microproteins in human brain tissue, including some that are altered in Alzheimer’s disease
Microproteins are small proteins with fewer than 150 amino acids and are notoriously difficult to detect with standard gene and protein sequencing techniques. In a study published in Nature Aging on 14 September, researchers combined several methods to pinpoint the tiny molecules in post-mortem samples of the dorsolateral prefrontal cortex — a region of the brain involved in cognitive control — from people with and without Alzheimer’s disease (AD).
They identified 4,321 microproteins, 3,217 of which had not been previously characterized in a standard catalogue of human proteins called UniProtKB/Swiss-Prot. Dozens of the tiny proteins showed altered expression in people with AD, which could pave the way to unlocking new mechanisms of aging and neurodegeneration.
Read the publication in Nature Aging
12. Engineered human bone and lung MPS to examine human breast cancer cells metastasis
Metastatic tumor cells must undergo multifaceted adaptation to migrate to and colonize distant organ tissues. In vivo preclinical xenograft models fail to fully replicate the human tissue niche to interrogate this process.
In a new study, Chramiec et al. built a microphysiological system of engineered human bone and lung linked by vascular flow to examine the extravasation and colonization of human breast cancer cells in vitro. Distinct patterns of tissue colonization and secreted factors demonstrate that this device recapitulates key features of organ-specific metastasis observed in vivo for this family of cell lines. The system will support further study of organ-specific colonization and tumor-niche adaptation in human tissues.
Read the publication in Science Translational Medicine
WORTH (RE)SHARING
Helena Kandarova awarded Eurotox honorary member 2026
European Innovation Act: A strategic regulation for Europe’s innovation future
Wall Street is wary of NAMs — And for good reason: What Happened to yesterday’s drugs? – By Zaher Nahle, Ph.D., MPA, Drug Discovery Online
Educational and training needs of regulatory professionals for non-animal methodologies: Insights from a survey – Nachira et., ALTEX
Finding a place for new approach methodologies (NAMs) in biomedical research – Schaffert et al., Lab Animal
Moving NAMs from progress to practice: Building the foundation for broader adoption – Article published in Fierce Biotech
Release the rabbits: What two decades of EU skin irritation testing trends reveal about replacing animal models – By Vesna Adjei
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Advancing the human Liver-Chip toward FDA qualification: A new era for DILI prediction – September 29, 2026, 11:00 am — 12:00 pm EDT, online
Predictive Human Biology Symposium – September 30, 2026, Karolinska Institutet, Stockholm
Berlin Organoid Symposium — 2nd Edition – October 6 – 7, 2026, Berlin
