NAMs News
November 09 - 13, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. EU’s animal testing phase-out hinges on regulators, not labs, says MEP Tsiodras
Europe has spent heavily on finding alternatives to animal testing. The harder task, according to Dimitris Tsiodras, is persuading regulators to use them. “The main obstacle is the gap between developing promising methods and making them usable in regulatory decisions,” said the Greek MEP, who is steering key parts of the EU’s One Substance, One Assessment (OSOA) reform through the European Parliament.
Tsiodras is also co-rapporteur on a proposal to simplify chemicals rules, including the Classification, Labelling and Packaging (CLP) Regulation. Speaking ahead of a conference of the European Partnership for Alternative Approaches to Animal Testing (EPAA), he set out what Brussels must do next.
2. The MHRA Strategy 2030 includes in silico evidence, digital twins and hybrid clinical trials among its priorities
Scientific and technological advances are reshaping how disease is prevented, diagnosed and treated. Artificial intelligence (AI) is transforming both regulated products and how organisations are run. Cell and gene therapies are offering the possibility of long-lasting or curative treatments. Precision and personalised medicines are changing how benefit and risk must be assessed. Advanced diagnostics are driving earlier intervention and better outcomes for patients.
The Medicines and Healthcare products Regulatory Agency (MHRA) Strategy enrolls in a rapidly evolving global landscape, with regulators worldwide playing a greater role in global supply chains and market access. As treatments become more complex, safety systems must evolve. The MHRA will move to continuous, real-time safety assurance using data, analytics and AI to identify safety risks earlier and respond more quickly, to protect patients throughout the full lifecycle of medicines and medical devices.
3. Beyond animal testing to human cells: MFDS to establish Korea-led standards for 'mini organs'
In line with the shift toward more relevant models to human and next-generation safety assessment technologies, the Korean Ministry of Food and Drug Safety (MFDS, ex KFDA) is moving toward the international standardization of toxicity testing methods utilizing organoids. The goal is to develop domestically developed testing methods into OECD testing guidelines, thereby establishing them as safety assessment methods that can be utilized internationally.
To this end, the MFDS is investing a total of 47.5 billion won from 2024 to 2028 to conduct research on the standardization of alternatives. An official from the Ministry of Food and Drug Safety stated: "We are currently drafting a detailed OECD review report examining the scientific validity and regulatory applicability of liver organoid-based toxicity testing methods". The MFDS aims to begin submitting the SPSF (Standard Project Submission Form) in 2026, adopt the project in 2027, complete the validation study in 2028, complete the guidelines in 2029, and adopt the OECD testing guidelines in 2030.
A further milestone was reached on 3 November 2026, when the OECD opened a public consultation on the first chapter of its Draft Detailed Review Paper on liver toxicity testing using 3D in vitro models, with a particular focus on human iPSC-derived technologies (see below info 7).
Read more (KR)
4. Seven test methods incorporated into STSC in China
On November 2, 2026, China National Medical Products Administration (NMPA) issued an announcement to incorporate seven inspection (test) methods into the Safety and Technical Standards for Cosmetics (STSC). Among the two newly added inspection (test) methods: the Vitrigel-Eye Irritancy Test Method. The five other methods are revised test methods, replacing the original methods in the STSC.
The Vitrigel-Eye Irritancy Test Method (OECD Test No. 494) is a standardized in vitro assay used to identify chemicals and mixtures that do not require classification and labeling for eye irritation or serious eye damage. The seven methods will be implemented on two different dates, and the difference in timing deserves attention. CIRS Group (a product safety and regulatory consulting firm) has compiled and sorted out the core content for reference.
5. Can virtual hearts predict real-world drug risks?
Cardiovascular disease is the leading cause of death worldwide. However, despite massive investment in drug discovery and development, the number of approved drugs has not kept pace. This is partially due to cardiovascular toxicity, as drug-induced cardiac side effects can derail promising candidates during clinical development or lead to serious adverse reactions after approval. Computational models could help bridge this gap by modelling how variables (differences in biology, drug exposure, and experimental measurements) might influence cardiac safety.
By simulating drug responses across different concentrations and biological conditions, researchers can explore scenarios that would be difficult, costly, or unethical to test directly in people. But how much should drug developers trust the predictions — particularly when the experimental data behind them are uncertain? In a study published in Regulatory Toxicology and Pharmacology, researchers used AI-powered cardiac models to investigate that very question.
INTERVIEWS, NOMINATIONS & AWARDS
6. NWA Do-ReACT new project for validation of animal-free models
The project Regulatory Embedded Strategies for the Promotion Of NAM Adoption (RESPOND3R) has received a grant of € 3.44 million within the NWA Do-ReACT call for proposals.
The project aims to advance the validation and acceptance of animal-free models for the safety assessment of chemical substances. The RESPOND3R consortium, led by Prof. Mirjam Luijten and Prof. Anne Kienhuis of the Dutch National Institute for Public Health and the Environment (RIVM), will work over the next 5 years. The consortium consists of: RIVM, Utrecht University, Utrecht University of Applied Sciences, Leiden University, Maastricht University, Wageningen University, Charles River Laboratories, Ombion, Stichting Proefdiervrij, KWR Water B.V., Unilever, InSphero AG, Axion Biosystems, Institute for In vitro Sciences.
TOOLS, PLATFORMS, CALLS
7. OECD: First commenting round on Chapter 1 of a Draft Detailed Review Paper on liver toxicity test methods using liver organoids
The OECD is currently developing a Detailed Review Paper (DRP) under the OECD Test Guidelines Programme, on test methods for the assessment of liver toxicity using 3D in vitro models, with a focus on human iPSC-based models for regulatory purposes. This work responds to the increasing need for non‑animal methods for regulatory toxicology and the current absence of OECD Test Guidelines addressing liver toxicity endpoints in 3D liver systems.
The draft DRP includes two chapters:
- Chapter 1, which provides an overview of iPSC technology and of the international efforts undertaken to support the development, characterisation, and standardisation of iPSC-derived models.
- Chapter 2, which focuses on liver microphysiological systems, with particular emphasis on human iPSC-derived liver organoids.
The current consultation is limited to Chapter 1, as the two chapters are being developed on slightly different timelines. Submission period: 3 November - 11 December 2026
Read more and participate in the consultation
8. NCATS/NIH new QuSAFE Challenge: Quantum-Enabled Approaches for Predictive Preclinical NAMs for Toxicity and Safety
The National Center for Advancing Translational Sciences (NCATS) is announcing the Quantum-Enabled and Advanced Detection Approaches for Predictive Preclinical NAMs for Toxicity and Safety (Qu-SAFE) Challenge as part of the NIH Quantum Biomedical Innovations and Technologies (Qu-BIT) Program.
With a total prize pool of USD7.1 million, this Challenge aims to identify and develop proof-of-concept and prototype sensing systems that demonstrate how quantum-enabled approaches alone or in hybrid quantum-classical and other advanced sensing and detection approaches and configurations can improve detection and measurement in in vitro NAMs (New Approach Methodologies) for toxicity, safety and other preclinical assessments. The goal is to enable new types of data and biological signals that cannot be measured today, thereby improving the predictive capability of preclinical models to generate robust, human-relevant data for drug development and safety evaluation.
- Challenge Stage 1
- Proposal submission period starts: December 31, 2026
- Ideation and Planning proposal submission deadline: July 27, 2027
- Announcement of Winning Submissions: November 2027
INDUSTRY, BIOTECH & PARTNERSHIPS
9. VivoSim Labs and Chemveda Life Sciences join forces to put AI-designed drug candidates to the human test
VivoSim Labs, Inc., a provider of AI-enabled NAMs for preclinical safety, and Chemveda Life Sciences, an integrated contract research, development and manufacturing organization (CRDMO), announced a strategic collaboration. Under the collaboration, Chemveda will support the design, synthesis, optimization and development of AI-designed compounds for pharmaceutical and biotechnology clients, while VivoSim will evaluate selected compounds using its NAMkind™ Liver and NAMkind™ Intestine human tissue models, built from primary human cells.
The science behind the partnership is already proven, explained the press release. Across a clinical dataset of 92 small-molecule compounds, VivoSim’s NAMkind™ Liver model predicted drug-induced liver injury with 91% accuracy, 90% sensitivity and 95% specificity. On compound sets where animal models and traditional methods detect only 50–65% of true liver toxicants, VivoSim’s models have exceeded 90% sensitivity.
10. abc biopply and Panome Bio collaborate
abc biopply AG, Europe's fully integrated Organoid CRO, and Panome Bio, a leading US multi-omics CRO specializing in Next-Generation Metabolomics and integrated multi-omics analysis, announced the signing of a strategic collaboration agreement aimed at expanding the availability of standardized, human-relevant preclinical data generation and advanced molecular analytics for pharmaceutical and biotech drug developers.
The partnership brings together two highly complementary capabilities. This will provide deeper physiological insights and biomarker discovery opportunities from studies conducted using 3D CoSeedis Multi-Organoid disease models. Arne Faisst, Founder and CEO of abc biopply, commented: "The future of preclinical development lies in generating data that is both biologically relevant and mechanistically informative”
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Drug-induced gastrointestinal toxicity: From pathophysiological mechanisms to human-relevant preclinical models
Drug-induced gastrointestinal toxicity (DiGIT) represents a major dose-limiting adverse effect that severely compromises patient outcomes and therapeutic efficacy across global populations. Frequently triggered by chemotherapeutic agents and non-steroidal anti-inflammatory drugs (NSAIDs), DiGIT spans a clinical spectrum from mild dyspepsia to life-threatening complications, including severe mucositis, ulceration, and gastrointestinal (GI) bleeding.
In a new review, researchers provide a comprehensive analysis of DiGIT across the upper and lower GI tracts, examining the distinct toxicity profiles of NSAIDs and chemotherapy. They detail the underlying pathophysiological mechanisms, focusing on drug-induced epithelial damage, innate immune system activation, and microbiome dysbiosis, alongside current supportive management strategies. Finally, they highlight the preclinical landscape of in vitro toxicity testing, outlining how emerging, physiologically representative bioengineered models can better evaluate GI safety, streamline risk assessment, and improve candidate drug success.
Read the article in Frontiers in Bioengineering and Biotechnology
12. Microfluidic engineering for organoid formation, cultivation, and sensing
Organoids have emerged as powerful in vitro models for studying tissue morphogenesis, organogenesis, and disease mechanisms. However, they are typically generated and maintained in static culture without perfusion, a configuration that imposes fundamental biophysical constraints and thereby restricts their physiological relevance.
A recent review examines how microfluidic engineering addresses these limitations across the entire organoid workflow, from formation and long-term culture to integrated biosensing and discusses the path toward regulatory qualification of such platforms and their potential to advance personalized medicine while reducing reliance on animal testing.
Read the article in Frontiers in Bioengineering and Biotechnology
WORTH (RE)SHARING
“Beating cardiac organoids offer a platform for drug screening” – The Scientist
“Functional readouts of neural organoids” – In-Hyun Park et al. – Nature Reviews Bioengineering
FDA’s iSTAND program – New LOI accepted:
- NEXEL for a cardiac safety pharmacology assessment method based on its Cardiosight®-S product
- Axion BioSystems for its human iPSC-neural seizure liability MEA assay, joining its cardiac proarrhythmia project
Translational Reproductive Medicine group (Utrecht University) received the Utrecht Life Sciences Technology Voucher for Early Career Researchers
“Meet the Researchers series”: Interview with Dr Diana Papp, Imperial Organoid Facility “Turning scientific ideas into meaningful research discoveries”
NIH ORIVA Opportunity for Pharmaceutical Companies and NAM Developers
EP PerMed Joint Transnational Call 2027: “Cell and Gene Therapy for Personalized Medicine” opened
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Anr Symposium “Méthodes non animales pour la recherche en biologie-santé” – 17 November 2026 – Paris (France)
EPAA Annual Conference 2026 “Implementing the Roadmap: Working together in EU and beyond” – 17 November 2026 – Brussels (Belgium)
“European Biotech Clusters: Connect. Collaborate. Scale”, 19 November 2026, 2:00-6:30pm (CET) – Brussels (Belgium)
Webinar: “Chip off the old block: How predictive, human-relevant data is de-risking clinical trials” – 20 November 2026, 11:30am (CET) – online
Conference “Microfluidics for Biomedical Innovation: Organoids and Organs-on-Chips Shenzhen 2026” – 21 & 22 November 2026 – Shenzhen (China)
SAAE-India 9th Annual Conference, CT University – 26-28 November 2026 – Ludhiana, Punjab (India)
