NAMs News
JUNE 29 - JULY 03, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Two speeds of NAMs: AI-data generation or standardization first?
The regulatory door is open. That is not the same as the science being ready.
The FDA Modernization Act 2.0 (2022) removed the statutory mandate that every investigational new drug undergo animal testing. The April 2025 FDA Roadmap committed the agency to reducing animal use, beginning with monoclonal antibodies. The FDA Modernization Act 3.0 passed the Senate by unanimous consent on December 16, 2025 and cleared a House subcommittee in May 2026, though it has not yet been enacted. The direction of travel is unambiguous.
The NAMs (New Approach Methodologies) label covers technologies separated by twenty years of methodological maturity. A recent perspective by Stefano Gaburro draws one distinction.Some human-relevant models are mature enough that the immediate priority is generating AI-ready data at scale. Others are early enough that generating large data volumes before standardization would manufacture noise, not signal.Knowing which model sits where is now a strategic question, not an academic one.
2. FDA draft guidance on QSP-based dose selection in first-in-human trials
The US Food and Drug Administration (FDA) has released a draft guidance entitled “Quantitative Systems Pharmacology (QSP)-Based Dose Selection Using Minimum Anticipated Biological Effect Level (MABEL)”. The document outlines how sponsors can use QSP models to support the selection of safe and scientifically justified first-in-human doses, particularly for high-risk biological products such as monoclonal antibodies, bispecific antibodies, and T cell-engaging therapies.
While it is not a guidance specifically on NAMs, it reflects the FDA’s continued support for model-informed drug development (MIDD) and the increasing regulatory acceptance of mechanistic, human biology-based computational approaches. By integrating human biological knowledge and diverse experimental data, QSP models can improve dose prediction and help strengthen decision-making in early drug development.
3. Threshold in immunology: Where data is no longer the limiting reagent – explanation is
A new commentary explores how advances in spatial multi-omics and single-cell technologies are transforming our understanding of immunosenescence, providing unprecedented insights into the ageing human immune system. By integrating spatial transcriptomics, proteomics and chromatin profiling, researchers can now map age-related changes in immune cell populations and tissue architecture at remarkable resolution.
The author argues, however, that generating increasingly detailed datasets is not enough to drive therapeutic innovation. While these technologies reveal where and how immune ageing occurs, they often fall short of identifying causal mechanisms or actionable intervention points. The article calls for a stronger emphasis on mechanistic, human biology-based models and experimental strategies that can translate complex biological data into predictive insights and more effective therapies.
4. In vitro cardiac NAMs predict clinical cardiovascular repolarization risk comparable to non-clinical traditional studies
A pilot study of over 20 Investigational New Drug (IND) applications submitted to the FDA between 2020 and 2023 were retrospectively analysed. The study compared human iPSC-derived cardiomyocyte (hiPSC-CM) data for assessing cardiovascular repolarization risk, with traditional non-clinical methods (hERG assays and animal studies).
Among key results, the study shows that hiPSC-CMs displayed greater overall concordance relative to non-clinical animal studies than hERG studies. hiPSC-CMs demonstrated comparable likelihood ratios and overall accuracy in predicting clinical QT prolongation relative to single-dose in vivo non-rodent QT and other animal studies. Although limitations include small sample size, low prevalence of clinical QT true positives, early-phase data, and variability in hiPSC-CM study rigour, hiPSC-CMs offer a promising alternative to extensive animal testing for cardiovascular risk assessment.
INTERVIEWS, NOMINATIONS & AWARDS
5. “Sciences, Enjeux, Santé N121”: Interview with Prof. Matthias Lütolf
In this in-depth interview, Prof. Matthias Lütolf, founding director of the Institute of Human Biology (IHB Roche) looks back on the scientific milestones that have shaped his career, both in academia and in industry, from his pioneering work on organoids at the École Polytechnique Fédérale de Lausanne to his role as head of the Translational Bioengineering Laboratory at Roche. He explains how engineering principles, automation and AI are transforming organoids into predictive models relevant to humans in the context of drug discovery, whilst addressing the key scientific, industrial and regulatory challenges that still stand in the way of replacing animal testing and accelerating translational medicine.
Sciences, Enjeux, Santé is a quarterly magazine created in 1994 by Pro Anima Scientific Committee dedicated to the promotion of non-animal methods. Interviews are available online, both in French and English.
TOOLS, PLATFORMS, CALLS
6. PEPPER 2026: Call for endocrine disruption test methods
Every year, PEPPER supports the validation of innovative test methods for addressing gaps in endocrine disruption assessment – and the 2026 selection round is now open.
PEPPER invites public and private laboratories to submit methods that:
- Demonstrate high technological maturity (solid written protocol and sufficient data — see ReadEDTest);
- Address regulatory needs (especially for modes of action currently lacking validated tests);
- Fit into integrated assessment strategies; Show strong potential for dissemination across laboratories; Present no legal or logistical barriers.
Deadline for submission: 31 August 2026
Read more & submit your test method
7. The new Open Lab ECVAM call is now open
EURL ECVAM is offering open access to its High Throughput Testing (HTT) laboratory to users that want to automate their in vitro methods to evaluate their transferability, reliability and overall performance, and to generate large datasets on bespoke compound libraries to assess relevance for targeted applications, such as non-animal approaches to toxicological testing for the regulatory safety assessment of chemicals.
A document outlying Technical Specifications of the HTT laboratory is available, providing detailed information on the equipment available in the HTT laboratory and the technical specifications that should be complied with in order to efficiently and effectively transfer a method to the ECVAM laboratory.
Deadline date: 10 September 2026
To see more calls: Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
8. Tentamus acquires BioMeca and strengthens its life sciences portfolio
The Tentamus Group announced the acquisition of BioMeca, a Lyon-based biotechnology company specializing in biomechanics and mechanobiology, expanding Tentamus’ expertise in the life sciences sector. The strategy will provide expansion particularly in the high-resolution structural and mechanical characterization of biological samples, including tissues, cells, DNA, and proteins; this, to support industries such as cosmetics and pharmaceuticals.
By integrating BioMeca’s cutting-edge technologies and deep expertise, Tentamus will enhance its ability to deliver comprehensive, high-value services to clients worldwide, while maintaining a strong local presence in France. “This partnership will allow us to scale our impact, invest in new technologies, and better serve our clients with the backing of a global leader in laboratory services.” said Julien Chlasta and Gaël Runel, CEO and Founder of BioMeca, and R&D Director.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Pregnancy-associated OOC: Revolutionary insight
The understanding of gestational health and disease have been limited by traditional models which struggled replicating the complex physiological processes, involving continuous adaptations across maternal and fetal systems. New microphysiological models are emerging as powerful tools to better mimic human pregnancy and advance research in this field. Central among these innovations are pregnancy-associated organs-on-chips (PAOOCs), which promise to unlock new perspectives on maternal-fetal biology, disease pathology, and therapeutic testing.
In a recent review, researchers analyse PAOOCs, focusing on design parameters that enhance their fidelity to model pregnancy physiology and pathology. They discuss how microenvironmental changes during gestation inform device engineering and provide an application-driven perspective linking biology with design, reproducibility and scalability considerations. This review also highlights PAOOCs’ potential as platforms for elucidating the mechanisms of gestational diseases, assessing drug efficacy and safety during pregnancy, and advancing reproductive bioengineering for maternal and fetal health.
Read more in Nature Reviews Bioengineering
10. Patient-derived cortical brain organoids reveal mechanism and treatment for rare genetic disease
At the annual conference of the European Society of Human Genetics in Gothenburg, Sweden, researchers presented their work on the first cortical brain organoid models of dehydrodolichyl diphosphate synthase (DHDSS)-related disease — a rare condition with no current treatments. This pioneering work, led by Dr Eva Morava and Dr Tamas Kozicz’s team at the Icahn School of Medicine, allowed the scientists to not only elucidate the mechanism of the disease, but also test out a widely available therapeutic — nicotinamide mononucleotide, better known as vitamin B3.
“We are the first research team who developed cortical brain organoids in the disease group CDG,” Morava told Drug Discovery News. “Having this model available for a patient with rare disease allows us to develop personalized treatments for the genetic disorder representing the exact and full genetic makeup in disease-relevant tissue.”
Read more in Drug Discovery News
11. Human vs. cells vs. machine: A comparative analysis of toxicological points of departure
Read-across is an expert-driven NAM used to fill gaps in chemical toxicity data. While qualitative read-across is widely used, quantitative read-across (qRAx) for deriving points of departure (PODs) has received limited attention. A recent study by Chiu et al. systematically compares quantitative read-across (qRAx), in vitro to in vivo extrapolation (IVIVE), and quantitative structure – activity relationship (QSAR) approaches for deriving toxicological points of departure (PODs).
The authors identified 41 substances evaluated by the US EPA’s Provisional Peer-Reviewed Toxicity Value (PPRTV) program for qRAx-derived oral chronic PODs. Concluding that well-calibrated in silico methods can rapidly derive PODs with defined uncertainty, supporting time-sensitive health risk decisions, this work strengthens confidence in integrated NAM approaches as practical alternatives to traditional methods – marking a significant shift toward transparent, scalable, and science-driven regulatory toxicology.
Read the article in Regulatory Toxicology and Pharmacology
12. Lab-on-a-Chip platform shows how immune cells attack cancer cells
Immunotherapies are a promising approach in the fight against cancer. Researchers at the Technical University of Munich (TUM) have developed a lab-on-a-chip system called CellTrap. It makes it possible to observe the interactions between immune cells and cancer cells at the single-cell level. The method is intended to help better understand fundamental processes in cancer immunology and answer key questions.
“With CellTrap, we can not only measure whether immune cells kill cancer cells, but also track when and under what conditions this occurs. This matters, because immune responses can vary so much from one cell to the next,” says Ghulam Destgeer, Professor of Control and Manipulation of Microscale Living Objects at the TUM School of Computation, Information and Technology. “And we deliberately kept the platform simple and affordable: it runs on a standard fluorescence microscope of the kind most labs already have, with no specialised equipment.”
Read the article in RSC Advances
13. A practical gut-on-chip workflow for imaging-based assessment of epithelial barrier dynamics
The intestinal epithelium and its resident microbiota form a dynamic interface that is central to gut homeostasis, but this interface is difficult to model with conventional tools. OOC technology offers a way to recreate key physical and biological features of the gut, yet many existing gut-on-chip systems remain technically demanding or poorly standardized for routine use.
In a new study,Guan-Yu Chen (Anivance AI), with Shih-Wei Chiang (Taichung Veterans General Hospital) and Chuan-Yi Yang (National Yang Ming Chiao Tung University) developed and validated a practical gut-on-chip workflow that enables reproducible, imaging-based quantification of epithelial barrier dynamics during short-term co-culture with Escherichia coli. The workflow provides an accessible test-bed for quantitative studies of early host – microbe interactions and can be readily extended with orthogonal barrier readouts, such as TEER (Transepithelial/Endothelial Electrical Resistance) or tracer permeability, in future work.
Read the study in Biotechnology and Bioengineering
WORTH (RE)SHARING
Mapping the evolutionary landscape of intestinal organoids: From self-organization biology to precision medicine, published in Stem Cell Research and Therapy
Y‑Chip: The first draft of what could become the world’s first fully autonomous RNA therapeutic discovery chip, by Aman Iqbal
Validating human heart models to improve drug safety testing: reNEW Leiden Associate Investigator Richard Davis has been awarded funding through the transnational ValNAM programme
How the EURL ECVAM is contributing significantly to the implementation of the roadmap
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
ISSCR (International Society for Stem Cell Research) Annual Meeting – 8 – 11 July 2026, Montreal (Canada)
The NAMolution of Regulatory Science Seminar – Session 6 – 14 July, 2026, 18h00 — 19h00 (UTC+2), online
