NAMs News
October 26 - 30, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. EMA: New Approach Methodologies Operational Expert Group
On October 6, the EMA published the provisional mandate, objectives and rules of procedure for its New Approach Methodologies Operational Experts Group (NAMs OEG). The operational expert group supports the scientific and regulatory evaluation of New Approach Methodologies (NAMs), and their use in regulatory decision-making and contributes to the development of regulatory knowledge, consistency and expertise in NAMs across the European medicines regulatory network.
The group carries out the following activities:
- Reviews and discusses NAM data, proposed contexts of use and potential regulatory applicability
- Identifies scientific and regulatory challenges, uncertainties and opportunities to integrate NAM data into evidence-based assessments
- Provides feedback on the potential relevance of submitted NAMs and possible regulatory follow-up pathways
- Promotes consistent interpretation and assessment of NAM data across the European medicines regulatory network
- Supports knowledge sharing and training to advance the development, validation and regulatory uptake of NAMs
2. White paper calls for India to advance human-relevant research, phase out animal testing
A new joint white paper was released by Humane World for Animals India and the Confederation of Indian Industry (CII) at CII’s Global Summit on Industrial R&D and Competitiveness. Titled ‘New Approach Methodologies as an Emerging Sunrise R&D Sector for India’, the paper calls for a national strategy to accelerate the development, manufacturing and adoption of NAMs.
Countries around the world are shifting toward these new technologies. The report warns that India risks becoming primarily a consumer of technologies developed elsewhere rather than a developer, manufacturer, and supplier.
3. Japanese perspective on NAMs for regulatory use
In the safety assessment of chemicals and pharmaceuticals, international efforts toward the regulatory acceptance of NAMs that do not rely on animal testing are accelerating. Scientific validation of such methods and the establishment of acceptance frameworks by regulatory authorities are indispensable for the societal implementation of NAMs. There is an urgent need to establish a system in Japan that reflects the domestic context while ensuring international harmony.
Read more in Current Opinion in Toxicology
On October 20, the Japan Pharmaceutical & BioScience Society announced a meeting dedicated to NAMs, scheduled for December 5, 2026, in Tokyo, to be held in a hybrid format. The program will bring together representatives from the pharmaceutical industry, academia, and the Japanese regulatory authority (PMDA) to discuss the development of NAMs, their use in R&D, their regulatory acceptance, and their commercialization.
4. Human brain organoids come of age – but still have room to grow
As the U.S. and Europe increasingly shift away from animal research, organoids have been touted as a promising alternative method for studying the brain. The field has made significant progress since human brain organoids debuted in 2013. Researchers can now coax these clusters, fashioned from stem cells, to integrate a variety of cell types, including microglia, astrocytes and interneurons. They can even fuse brain-region-specific organoids into structures called assembloids that closely resemble circuits within the brain.
Neuroscientists are leveraging a variety of strategies to make more complex and biologically accurate organoids that are more reproducible and representative of a later stage in human development, says Hongjun Song, professor of neurological sciences at the University of Pennsylvania to Claudia López Lloreda, reporter at The Transmitter. “The next frontier now is moving beyond general cell types, and see [if we can] study other biology. For example, now can we study circuitry formation? We’re not really quite there yet, but there are methodologies to study the next step.”
INTERVIEWS, NOMINATIONS & AWARDS
5. Miniature ‘organ avatars’ for a better understanding of the human body: An interview with Professor Meritxell Huch
Meritxell Huch, a stem cell biologist, Director at the Max Planck Institute of Molecular Cell Biology and Genetics, and an internationally recognised expert in organoid research, came to Budapest for the Building Bridges 2026 conference, where she received the Academia Europaea Sydney Brenner Medal and gave a lecture on her research.
The Hungarian Research Network spoke to her about what laboratory-grown organoids can teach us about the function of human tissues, how these models can help us better understand regeneration, and the role they may play in the future of drug development and medicine.
TOOLS, PLATFORMS, CALLS
6. JRC Summer School on non-animal approaches in science – Inspiring global impact
The JRC announced the sixth edition of its Summer School on Non-Animal Approaches in Science organised by the European Commission's Joint Research Centre and its EU Reference Laboratory for Alternatives to Animal. The Summer School will take place in Ispra, Italy, from Monday 24 May 2027 to Friday 28 May 2027.
The summer school offers enthusiastic students (Master or PhD) or early-career scientists (maximum 4 years after completing studies) with a strong interest in non-animal approaches the opportunity to learn from experts in the field, share knowledge and experience with peers, and build a professional network. The school is free of charge, and open to a maximum of 120 participants.
Applications will open on 5 November 2026 and should be submitted by 22 January 2027.
INDUSTRY, BIOTECH & PARTNERSHIPS
7. Another major milestone for the Emulate human liver-chip
In a recent post on Linkedin, Emulate announced its notification by the FDA that its Full Qualification Package has been deemed “Reviewable” as part of the ISTAND program.
By this notification, the FDA has determined that the submission from Emulate “contains the information needed to move forward into comprehensive review – bringing the Human Liver-Chip another step closer to potential qualification as a Drug Development Tool for assessing drug-induced liver injury (DILI)”.
8. Securecell and Beckman Coulter Life Sciences team up to automate cell culture monitoring
Securecell and Beckman Coulter Life Sciences are collaborating on the integration of the Vi-CELL BLU Cell Viability Analyzer with Securecell's Numera® 3 automated sampling platform, creating a more automated workflow for cell culture monitoring.
The new integration will combine automated liquid sample transfer with digital connectivity to enable a more seamless workflow from bioreactor sampling to cell analysis and process data.
“Automating sample collection is only part of the challenge. The real value emerges when sampling, analytical instruments, and process information can operate as one connected workflow,” said Boris Hamouda, Head Numera Operations, Securecell . “By combining Numera® with the Vi-CELL BLU analyzer and integrating the workflow with Lucullus®, we aim to make important cell culture information available with significantly less manual intervention.”
9. Rivercell launches with $25 million to build data platforms and AI models that predict how human cells respond to treatment
Founded by entrepreneur and CEO, Yann Fleureau, and former AI research leader at Novartis and Owkin Eric Durand, Rivercell, a Paris-based biotechnology and AI company building its own data infrastructure on how human cells respond to any treatment and training a world model of the cell that can predict those responses, announced a $25 million seed round led by HV, with HCVC, Alven and Bpifrance Digital Venture.
“A world model of the cell is the opportunity of the century in medicine. The missing piece is data: how cells change over time and under treatment, seen through multiple lenses and at multiple layers, captured at scale. Building that data engine in Europe is strategic, not only for Rivercell but for the continent's place in AI and biology," said Yann Fleureau.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. Immunoids: Building immunocompetent organoids from human pluripotent stem cells
Pluripotent stem cell (PSC)-derived immunocompetent organoids and assembloids, termed as “immunoids” are becoming important human models for studying immune-tissue interactions. Advances across organ systems now include incorporation of mature and immature immune populations into multiple organoid types, multilineage differentiation, and endogenous immune co-development.
A new perspective article discusses why defining standards for immunoid fabrication will be essential for improving physiological modeling and clinical translation. In the coming years, as these platforms mature, immunoids are poised to transform research by advancing our understanding of human development, disease mechanisms, and therapeutic responses, becoming a cornerstone of precision medicine.
11. PDOs as functional avatars for antisense oligonucleotide-based personalized therapy
Patient-derived tumor organoids (PDOs) closely preserve the cellular heterogeneity, histopathology, and molecular features of the original tumors, making them powerful preclinical models. Antisense oligonucleotides (ASOs) are an emerging class of precision medicines that modulate gene expression at the RNA level with high target specificity, yet their application in organoid systems remains underexplored.
Thi Thom Tran and colleagues from Aix-Marseille University adapted previously described protocols to establish a biobank of prostate cancer (PC) PDOs, achieving a high initial growth success rate (>90%). Histological and molecular analyses confirmed the preservation of key tumor features. Using these models, the researchers assessed several ASOs, with particular emphasis on OGX-427 (Apatorsen), an ASO targeting heat shock protein 27 (HSP27) that has been evaluated in phase I/II clinical trials.
Read the article in Advanced Healthcare Materials
12. Functional precision psychiatry: iPSC-derived neurons as predictive assays for antidepressant response
Antidepressant treatment selection remains largely empirical, with many patients cycling through multiple therapies before achieving response. Pharmacogenomic (PGx) approaches have narrowed uncertainty at the level of drug metabolism, yet their ability to predict clinical efficacy has remained modest. This persistent gap highlights a broader challenge in psychiatry: the challenge in finding biologically grounded tools that can prospectively guide therapeutic choice.
A methodologically distinct approach is now generating translational evidence. Induced pluripotent stem cell (iPSC)-derived neuronal models enable the generation of patient-specific neurons, allowing direct pharmacological interrogation in a disease-relevant cellular context. These systems recapitulate key aspects of neuronal function, including synaptic activity, network connectivity, and stress-response signaling. Critically, patient-derived neurons can stratify antidepressant responders from non-responders at a functional level - capturing differences in synaptic connectivity, dendritic morphology, and gene expression that associative biomarkers cannot resolve.
Read the article in Neuropsychopharmacology
13. Millifluidic triMEA organoid platform with stretchable microelectrode arrays for parallel organoid electrophysiology
Organoids enable rigorous studies of neurodevelopment and disease, yet existing platforms often compromise between precise microenvironment control and reliable electrophysiological measurement. The challenge of achieving uniform perfusion alongside multi-well volumetric neural recordings limits parallel functional characterization and technical reproducibility across samples.
In a recent article, researchers present the triMEA millifluidic platform, which integrates three stretchable microelectrode arrays within a single device and delivers uniform perfusion across three independent wells. Using human midbrain organoids as a proof-of-concept biological model, they provide computational and experimental validation of the fluidic profiles and demonstrate electrophysiological recordings across all three wells under continuous perfusion. This platform establishes a reproducible and standardized foundation for parallel organoid interfacing.
Read the article in Lab on a Chip
WORTH (RE)SHARING
Distributed AI agents enable comprehensive discovery of biological insights at scale – Sun et al., bioRxiv (preprint)
A fluctuation test for gastruloid heterogeneity – Choi et al., Cell
Decoding microplastic toxicity on human health: navigating translational challenges using organ-on-chip models – Prasad et al., J Mater Chem B
Patient-derived vascularized organoid-on-a-chip model for therapeutic response assessment in synovial sarcoma – Huang et al., Precision Oncology
OrganoStart® PhD Package – Q4 Special Offer – MIMETAS
“Fifty Years of the Cosmetic Ingredient Review (CIR) and the Expert Panel for Cosmetic Ingredient Safety: An Independent, Transparent, and Science-Forward Program for Ingredient Safety Assessment” – Bart Heldreth et al., International Journal of Toxicology
The IHI Forum 2026 was held in Brussels, Belgium on 20-21 October. Watch recordings of the plenary sessions and find details of the speakers
Economic Valuation of Chemicals‑Related Health Effects – OECD
The US new Women’s Health Executive Order can accelerate human-based science – Science Advancement and Outreach
Evidence of animal methods bias in manuscript peer review: Results from a survey of in vitro researchers and bibliometric analyses – Krebs et al., Research Evaluation
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Scientific Advisory Committee on Alternative Toxicological Methods Meetings – November 4-5, 2026, online
SCRM Annual Meeting & Organoid and Organ-on-Chip Swiss Society Meeting 2026 – November 6, 2026, Bern (Switzerland)
European Research & Innovation Days 2026 – November 10-11 2026, Brussels (Belgium) and online
ISSCR’s webinar: Organoid Models in Tissue Architecture and Patterning – November 10, 2026, 10:00am-11:30am EST (online)
