News on non-animal methods
APRIL 27 - MAY 1, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Charles River highlights effectiveness of VCGs in toxicology
Charles River Laboratories International has shared the results of a retrospective analysis showing that virtual control groups (VCGs) can preserve scientific integrity while reducing reliance on animal models. The study looked at 20 toxicology studies that replaced concurrent control groups with curated VCGs and compared the outcomes across study-level decisions and detailed endpoints. There was 100 percent concordance in the No Observed Adverse Effect Level (NOAEL) across all studies, and although there was some minor endpoint-level variability between the concurrent control group (CCG) and VCG, the core study conclusions remained unchanged.
“By combining decades of curated historical data with advanced analytics, VCGs allow us to reduce animal use while preserving the highest commitment to scientific validity”, said Dr. Namandjé N. Bumpus, Chief Science and Innovation Officer, Charles River. Concomitantly with this analysis and as a reminder, the EMA is consulting on VCGs to help reduce animal use in medicines development.
Read the article in Regulatory Toxicology and Pharmacology
2. A perspective on the knowledge gap driving drug discovery’s longest feedback loop
In a new perspective article, Tsung Tan, manager at Primetech Corporation, argues that the biggest limitation in AI-driven drug discovery is not AI itself, but the still-limited understanding of human biology. With evidence suggesting we understand only around 10 – 15% of human biology, high clinical trial failure rates and slow pharmaceutical progress show that AI can only accelerate existing knowledge — it cannot replace missing biological insight.
The article highlights Insilico Medicine and its AI-discovered drug rentosertib as the strongest early proof that AI can help move drugs from discovery to clinical validation. However, while AI is already improving preclinical research, the real test will be whether AI-discovered drugs outperform traditional ones in Phase III trials over the next 5 – 10 years. Until then, both optimism and skepticism remain provisional.
3. FDA ISTAND Program: Determinations on 25 novel technologies
The FDA ISTAND Program to qualify New Approach Methodologies (NAMs) has now made determinations on 25 novel technologies. A few notable updates:
- Hesperos Inc.‘s Letter of Intent (LOI) was accepted. Their neuromuscular junction human-on-a-chip is being qualified to test botulinum toxin potency, signaling FDA’s willingness to break into more complex or multi-tissue systems ;
- AstraZeneca’s Qualification Plan (QP) was accepted for their AI to adjudicate causes of adverse clinical outcomes. Their acceptance letter comes with over 4 pages of highly technical notes and questions from FDA, underscoring the agency’s growing expectations and capabilities with ISTAND ;
- Javelin Biotech’s LOI was accepted for a liver-on-a-chip to assess risks from drug-drug interactions (DDIs), expanding ISTAND into newer Contexts of Use (COUs).
ISTAND is rapidly maturing and accelerating, expanding the potential for NAMs and firmly cementing the US as a leader in this space.
4. Institutional biobanking as shared public health infrastructure: a financially sustainable service center model
Institutional biobanks are essential infrastructure supporting clinical research, translational discovery, and public health preparedness. However, many biobanks rely on institutional subsidies or unstable grant funding, creating long-term financial vulnerability.
The Johns Hopkins Biobank, operating within the multi-division Genetic Resources Core Facility (GRCF), provides a practice-based example of a financially resilient model for academic biobanking. This case illustrates how aligning biobanking with institutional service center frameworks can strengthen financial sustainability, enhance accountability, and support long-term access to high-quality biospecimens as part of public health research infrastructure. In France, it is worth mentioning the initiative of FrBioNet, to map collections of biological resources across the country.
INTERVIEWS, NOMINATIONS & AWARDS
5. Maurice Whelan will join VPH2026 as a plenary speaker
The 9th International Conference on the Virtual Physiological Human (VPH2026), will take place in Milan from 1 to 4 September. On this occasion, Maurice Whelan, Deputy Director at the European Commission Joint Research Centre and Head of the Systems Toxicology Unit, will present: “Getting more out of computational modelling to benefit health and society in the EU”. His talk will explore how computational models can better support decision-making, strengthen regulatory frameworks, and deliver real impact for health and society.
Working at the interface of science and policy, translating innovative methods into regulatory practice across Europe, Maurice Whelan also leads EURL ECVAM, the EU reference laboratory driving the development of non-animal approaches to chemical safety assessment.
TOOLS, PLATFORMS, CALLS
6. EFSA: Procurement for services needed
Can you or your organisation provide the scientific, logistical or support services the European Food Safety Authority (EFSA) needs? EFSA buys services and supplies through public procurement calls, in line with EU legislation and the basic principles of transparency, equal treatment and non-discrimination, widest competition, proportionality and sound financial management.
Among the calls, some are NAM-related, such as: Evaluation of microbiome-relevant human biomarkers and in vitro models for xenobiotic risk assessment or Application of Human Biomonitoring (HBM) data in EFSA’s Chemical Risk Assessment. For more information on how to apply to EFSA calls and information on some of the EFSA science opportunities for 2026, further information is available here (webinar replay).
7. Exercises on results of in silico models and read-across using VEGAHUB
The European project PARC is organising the second edition of the remote training course on “Exercises on results of in silico models and read-across using VEGAHUB – Examples related to cosmetics and ecotoxicological and environmental properties”, continuing its series of hands-on trainings focused on the practical interpretation and application of in silico tools using the VEGAHUB platform.
This course is intended for intermediate-level researchers and risk assessors with prior experience in in silico modelling. This is a free, online course delivered over two days, with four sessions in total. The training will take place on 18 – 19 May 2026, with morning and afternoon sessions. The course is coordinated by the Istituto Mario Negri (IRFMN), Italy.
Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
8. InSphero launches a 3D platform for early gastrointestinal toxicity assessment
Drug-induced gastrointestinal (GI) toxicity is among the most common causes of dose limitations and late-stage clinical attrition. Yet pharmaceutical safety teams have long lacked a reliable, scalable in vitro tool to flag GI risks early in discovery.
InSphero, leader in 3D cell-based assays and organ-on-chip systems, recently announced the commercial launch of the 3D InSight™ Drug-Induced Gastrointestinal Toxicity (DIGIT) platform, a standardized, high-throughput screening solution for early assessment of GI liabilities in drug discovery. Key features of the platform include: patient-derived small intestinal organoids recapitulating native epithelial architecture, standardized monthly batch execution, automated imaging, decision-ready IC₅₀ values and more.
9. Mimetas Tumor – Vasculature-on-Chip: Modeling CAR T‑cell trafficking and efficacy in solid tumors
Solid cancers remain one of the leading causes of death worldwide, many of these diseases are deemed incurable or lack effective therapeutic options. Despite Chimeric Antigen Receptor (CAR) T‑cell therapy being a breakthrough in treating blood cancers, this therapeutic approach encounters significant obstacles for solid tumors – including immunosuppressive microenvironments, limited T‑cell infiltration, and resistance mechanisms that limit efficacy.
To study how CAR T‑cells reach and engage solid tumors, MIMETAS scientists developed a 3D tumor-on-a-chip model that combines patient-derived tumor cells with perfused vasculature, extra-cellular matrix (ECM), and customizable immune and stromal compartments to evaluate CAR T‑cell migration and killing capacity. This physiologically relevant model enables accurate tracking, evaluation, and optimization of CAR T‑cell therapies in solid tumors – from trafficking and infiltration to cytotoxicity.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. Hydrogels and cryogels as in vitro engineered 3D neurodegenerative models
Neurodegenerative diseases (NDs) represent a diverse set of incurable and debilitating conditions that have become increasingly prevalent in recent years. Model systems—in vitro as well as in vivo, are unable to precisely mimic the pathophysiology of NDs, making them less physiologically relevant.
To bridge this gap, 3D in vitro model systems are being developed, which are better suited to recapitulate the specific features of NDs. A comprehensive review provides a detailed insight into hydrogel- and cryogel-based 3D culture systems, comparing their structural characteristics, mechanical design and bio-functionality, along with their ability to mimic the complex pathological processes occurring in neurodegeneration. By critically assessing their advantages and limitations, the authors bring to notice their overall physiological relevance as far as understanding NDs is concerned.
Read the review in Journal of Materials Science
11. DNT IVB: Functional mapping of neurodevelopmental disease pathways
The Developmental Neurotoxicity (DNT) in vitro battery (IVB) enables efficient and human-relevant evaluation of chemicals for DNT potential.
To expand its biological applicability domain toward human disease, a new study maps neurodevelopmental disorder (NDD)-relevant signaling pathways to key neurodevelopmental processes (KNDPs) using primary human fetal neural progenitor cells (NPCs). Defining which NDD pathways can be functionally probed refines the DNT IVB’s biological applicability domain, increases confidence in its protective power, and supports mechanistic interpretation of NAM-based DNT assessment.
Read the article in Advanced Sciences
12. Derivation of a Point of Departure using NAMs for application in QRA
Ingredients with the potential to act as skin sensitizers differ markedly in their threshold for induction but can be used safely if their potency is characterized. To this end, the fragrance industry co-developed Quantitative Risk Assessment (QRA). Historically, QRA relies on a weight of evidence approach based on animal data, human confirmatory tests and read-across.
To allow an approach based solely on NAMs, the International Dialogue for the Evaluation of Allergens (IDEA) initiative, developed an extended Reference Chemical Potency List (RCPL) integrating human and animal data to derive potency values (PV). In a new study, researchers used PVs to evaluate the suitability of quantitative NAMs to derive a Point-of-Departure (NAM-PoD) for skin sensitization potency assessment. Evaluation of NAM-PoD indicates that the sensitization potency of fragrance chemicals can be reliably predicted using each approach.
Read the article in Regulatory Toxicology and Pharmacology
WORTH (RE)SHARING
PreclinicalTrials.eu a unique platform to preregister in vivo studies is launching a newsletter and sharing a new proof-of-concept preprint
Get ready for IHI Call 13 – launching this summer
JoVE Call for Abstract – Tissue-engineered in vitro models: Biomaterials, characterization, and three-dimensional fabrication approaches
NAMs Live Talks Session 3: How to mitigate the socio-technical barriers to the uptake of NAMs? – Replay available
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Scaling NAMs with automated standardization of 3D cell model – May 5, 10:00 – 12:00 am CET
Improving confidence in thyroid hormone disruption assessment using a novel human-relevant in vitro model – May 7, 5:00 – 6:00 pm CET
NAMs Live Talks Session 4: Europe in Transition — Scaling Human-Relevant Research Through NAMs – May 27, 10:00 – 11:00 am CET
