NAMs News
OCTOBER 05 - 09, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
The International Coalition of Medicines Regulatory Authorities (ICMRA) has adopted a joint statement developed and endorsed by the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (IHPRA) and Swissmedic calling on medicine developers, manufacturers, regulators and national control laboratories to continue advancing and implementing scientifically valid methods to replace animal testing throughout the lifecycle of human medicines.
It sets out the long-term goal of replacing animal testing at every stage of a medicine’s lifecycle, from initial screening and early development, through non-clinical testing, to licensing and post-authorisation activities.
2. NAMs in drug testing: India’s regulatory recognition is not enough
India is increasingly recognising New Approach Methodologies (NAMs), such as organ-on-chip and advanced cell-based technologies, as alternatives to traditional animal testing in drug development. These methods could make drug testing more human-relevant and potentially improve the prediction of how treatments will work in humans.
However, in a new article, Tejaswini Dhurde, Senior Science Communicator at the Centre for Predictive Human Model Systems (CPHMS), argues that regulatory recognition alone is not enough. India also needs investment in infrastructure, research, validation, standardisation, and scientific expertise to ensure that NAMs can be reliably adopted and used in pharmaceutical development.
3. The “INDUZELL” project: Producing stem cells on a large scale
A team of researchers from the University of Applied Sciences Emden/Leer and other partners are running the “INDUZELL” project, to develop a process that would allow cells grown in the laboratory to be produced on an industrial scale.
Stem cells are currently cultured in individual petri dishes, but large bioreactors could make the process more efficient, clinically relevant, and suitable for large-scale production. To achieve this, researchers are using artificial intelligence (AI) and machine learning to create a ‘smart’ production platform that combines engineering methods with experimental data to simulate stem cell growth and identify reliable conditions for producing intact stem cells in large bioreactors.
4. The role of AI in interpreting in vitro data
Organoids, organs-on-chips and other advanced in vitro models are especially important as they can accurately replicate human physiology, including tissue structure, flow, mechanical forces and interactions between cell types, more accurately than conventional methods. Their significance lies not only in generating more data, but also in producing evidence that closely reflects human conditions that researchers and regulators need to understand.
A new article on Sciences Enjeux Santé, explores a question that arises from this progress: once advanced in vitro models produce richer evidence, how can researchers interpret them reliably? The author, Chingkai Kung, PhD candidate at National Yang Ming Chiao Tung University and AI R&D Engineer in Bioinformatics at Anivance AI, focuses on discussing the role of AI in identifying patterns, integrating measurements and guiding experimental decisions, while recognizing that biological validation and a clearly defined context of use remain essential.
INTERVIEWS, NOMINATIONS & AWARDS
5. Lena Smirnova recognized by the Maryland Stem Cell Research Fund
Johns Hopkins Bloomberg School of Public Health Assistant Professor and MPS Program Director Lena Smirnova was recently awarded the Transformative Potential Award as part of the Maryland Stem Cell Research Fund (MSCRF)‘s 20th Anniversary Celebration.
Dr. Smirnova was selected for her “pioneering research and innovative integration of advanced human modeling approaches to deepen our understanding of disease and accelerate the development of future therapies.” Congratulations to Dr. Smirnova on this new recognition and her continued advancement of novel therapies and research modalities integrating stem cells and other human-based approaches.
TOOLS, PLATFORMS, CALLS
6. Chemicals regulation – update of EU rules for test methods
The EU’s REACH Regulation places controls on chemicals that may be potentially hazardous for humans, animals or the environment. One of its accompanying acts – Regulation 440/2008 – lists the approved methods for testing chemicals. This initiative will add a number of new/updated methods to that list, which have the potential to reduce and refine animal testing using chemicals.
This draft act is open for until October 27, 2026. Feedback will be taken into account for finalising this initiative. Feedback received will be published online and therefore must adhere to the feedback rules.
7. JRC Scientific Traineeships Programme
The Joint Research Center (JRC) is an active player in the global scientific research scene, working in a wide range of fields and playing its role as the European Commission’s science and knowledge service. JRC Scientific Traineeships Programme is now open for application. Depending on the project, the trainee will be expected to perform desktop work and/or laboratory tasks The place of traineeship can be one of the JRC sites. Candidates can indicate the site(s) of preference in the application.
Through this programme, recent university graduates (at least a standard 3‑year higher education degree) can:
- Acquire practical skills and knowledge in a multi-cultural, interdisciplinary environment;
- Work at the heart of scientific support for EU policies;
- Develop a network of contacts and build its career.
Deadline: October 28, 2026 15:00 Brussels time.
8. PARC Training school in immunotoxicology
PARC is organising an in-person training school in immunotoxicology, providing a comprehensive introduction to the mechanisms through which chemicals can interfere with the immune system and how these effects are addressed in chemical risk assessment. Particular attention will be given to current regulatory approaches and the opportunities and challenges associated with NAMs in immunotoxicology.
The training is intended for PhD students and researchers, both within and outside PARC, who are interested in immunotoxicology and its application to chemical risk assessment. The course is designed at a beginner level, and a background in immunology, cellular biology, or toxicology is recommended. The training will take place in Paris, France, from November 23 to 25, 2026. Submit your application by October 31, 2026.
INDUSTRY, BIOTECH & PARTNERSHIPS
9. ATCC’s advanced models platform: Helping to define the next generation of nonclinical research
ATCC, a non-profit biological resource center, has been selected for three new federal contract awards using NAMs to advance nonclinical research across infectious disease and oncology. The awards affirm ATCC’s position as a leader in NAMs and its work to build a trusted infrastructure for nonclinical science through authenticated, human-relevant models.
“The cell lines, organoids, validated biological models and microphysiological systems we distribute are each backed by comprehensive data sets fully traceable to their original source, giving researchers confidence in what they’re building on. That’s the foundation that reproducible science requires,” said Ruth Cheng, PhD, president and CEO of ATCC.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. 3D cell model that mimics myelin damage and repair in the human central nervous system
Myelin is a fatty sheath that covers and protects nerve fibres and allows messages to travel quickly around the brain, spinal cord and the rest of the body. In multiple sclerosis (MS), the immune system mistakenly attacks myelin, causing nerve damage, neurological symptoms and, over time, disability. There are currently no therapies available that repair this damage.
A research team led by Associate Professor Samantha Barton, heads of the Myelin in Health and Disease Group at The Florey, has developed a 3D cell model that mimics myelin damage and repair in the human central nervous system in unprecedented detail. “The relevance of our new system is significant. In addition to generating myelin, we have been able to introduce immune cells to trigger injury similar to MS. This gives us the unique opportunity to study the regenerative process of remyelination in the laboratory”, said Barton. Their research has been published in the journal Nature Neuroscience.
Read the publication in Nature Neuroscience
11. Brain assembloids offer a new window into how anesthesia works
Studying the brain’s response to anesthesia has been difficult: in living humans, there’s no safe way to study the brain cell by cell, and in animals, the drugs act on many different brain regions at once, making it hard to isolate where the effects arise.
UCLA researchers have shown for the first time that human stem cell-derived brain assembloids can reproduce the electrical changes seen during general anesthesia. Beyond advancing scientists’ understanding of anesthesia, their findings, published in the British Journal of Anaesthesia, expands what researchers can investigate, how human brain circuits generate — and change — their activity, using brain assembloids.
Read the publication in the British Journal of Anaesthesia
12. Mosaic human cortical organoids shed light on childhood epilepsy
Focal cortical dysplasia type II (FCDII), a major cause of paediatric drug-resistant focal epilepsy, results from brain somatic mutations in mTOR pathway genes.These mutations can affect various cell types in the developing brain-neurons, astrocytes, or oligodendrocytes —producing a mosaic pattern: some cells carry the mutation, others do not.
To uncover the mechanisms underlying FCDII, the Mosaic team at the Paris Brain Institute developed a new experimental approach. The researchers collected blood cells from a young patient carrying a mutation in the DEPDC5 gene (one of the main genes involved in FCDII) and from his unaffected brother. These cells were reprogrammed into induced pluripotent stem cells (iPSCs), then differentiated into human cortical organoids. This study provides novel insights into how DEPDC5 deficiency perturbs human corticogenesis, highlighting that mosaic biallelic inactivation of the gene is necessary for FCDII pathogenesis.
WORTH (RE)SHARING
Why reproducibility remains a challenge in preclinical research – Published on Drug Discovery News
NAMs in pharmaceutical development: Survey insights on adoption, infrastructure, and the path to broader implementation – Graham et al., Regulatory Toxicology and Pharmacology
Moving Toward Nonanimal Approaches in Medical Research and Testing – Van Norman & Krebs, Elsevier Book
New episode of “Cutting to the Case” with Prof Don Ingber
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
AI Day 2026 AI in biopharma: no longer theoretical – October 14, 2026, Georgia Room, NYC (US) and online
The validation journey of NAMs: practical examples in toxicology – October 20, 2026, Bern (Switzerland)
Workshop: Alternative Methodologies in Pharmaceutical Development – October 20 – 21, 2026, NIH Neuroscience Center Building, Maryland (US)
From innovation to first-in-human trials: Practical guidance for using NAMs in Australia – October 21, 2026, 4:30 – 5:15 pm, Gold Coast (Australia)
Asian NAMs’ Landscape: Scientific and Regulatory Perspectives – October 22, 2026, 12:30 – 1:30pm CET, online
DAIBR Workshop: Recent Developments in Human-Based Models – October 22 – 23, 2026, NIH Neuroscience Center Building, Maryland (US)
