News on non-animal methods
MAY 11 - 15, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. How ever-expanding organoids from epithelial stem cells were developed
A new publication in Cell Stem Cell describes the scientific journey of Prof Hans Clevers and his lab at Utrecht Institute, which began in immunology but shifted to intestinal stem cell biology after discovering that the Wnt signaling pathway controls the formation of intestinal crypt stem cells. By identifying the marker Lgr5, the lab demonstrated the existence of actively dividing intestinal stem cells responsible for renewing the gut lining. Their work connected normal stem cell regulation with cancer development, especially colorectal cancer driven by abnormal Wnt signaling.
Building on these discoveries, Clevers’ lab developed the first long-term intestinal organoid culture system by combining stem cells with key growth factors and MatrigelTM. These “mini-guts” replicated the structure and function of real intestinal tissue and became a major breakthrough for studying development, disease, and regenerative medicine. The story highlights the importance of curiosity, collaboration, and following unexpected scientific observations throughout the lab’s journey.
2. The arrival of digital twins and in silico trials in drug development
Digital twins and in silico trials are no longer peripheral concepts. They are becoming part of the mainstream scientific and regulatory discourse around drug development, precision medicine, and translational research. A new comment article in Nature Medicine frames them as emerging regulatory-grade evidence, marking a turning point for the entire field.
What is striking in the article is the recognition that the challenge is no longer whether these technologies matter, but how we validate, govern, standardize, and responsibly integrate them into healthcare and regulatory science. A new paradigm is emerging: one in which computational models are not merely supportive tools, but active components of biomedical decision-making.
3. A decade in the making: How functional NAMs are redefining cardiac safety assessment
In recent years, the momentum behind NAMs in drug safety testing has accelerated rapidly. In the US, driven by regulatory initiatives, evolving guidance, and growing internal pressure within pharmaceutical organizations, this acceleration can make it feel as though NAM adoption has arrived suddenly, almost overnight.
Cardiac safety has emerged as one of the clearest demonstrations of what regulatory-ready NAMs can achieve because it clearly illustrates the value of functional, human-derived physiology in safety decision-making. A recent regulatory milestone reflects this progress. A letter of intent submitted by Axion BioSystems for a human iPSC-derived cardiomyocyte microelectrode array (MEA) assay was accepted into the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program. That regulatory engagement reflects the growing confidence in functional assays capable of measuring human cardiac electrophysiology directly in vitro.
4. Top 10 Organoid Companies
The past year marked a proverbial inflection point for organoid models designed to uncover biological insights previously unattainable through traditional cell culture experiments or animal models. The changing regulatory climate in the US is expected to nearly triple the size of the global organoids market over the next five years, a projected $3.29 billion in 2031, according to a Mordor Intelligence report released in February.
Given their growing role in drug discovery and prospects for future growth, GEN has compiled its first-ever A‑List of organoid companies. A top five of private companies: Thermo Fisher Scientific, Merck, Danaher, Charles River Laboratories, and Corning. A a top five public companies: Emulate, Prellis Biologics, InSphero, CN Bio, and Inventia Life Science.
INTERVIEWS, NOMINATIONS & AWARDS
5. CAAT paper on the toxicology of tomorrow won 2025’s most cited paper award
Johns Hopkins Center for Alternatives to Animal Testing (CAAT) paper entitled “New approach methodologies in human regulatory toxicology – Not if, but how and when!”, on the toxicology of tomorrow, has won 2025’s Most Cited Paper Award from the journal Environment International.
The conceptual perspective presented in this paper has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It provides further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA).
6. Inside preclinical NAMs innovation: A Q&A with Labcorp experts on devTOX quickPredict™
Developmental toxicity assessment is undergoing a meaningful shift toward earlier, human‑relevant insight. In a new edition of Labcorp R&D Insight Series, Darren Kidd, a senior scientific leader in Labcorp’s in vitro Toxicology group and Jessica Palmer, the developer of the devTOX quickPredict™ assay, discuss how devTOX quickPredict™ is reshaping early-stage decision‑making, the growing role of NAMs in developmental toxicity assessment, and how integrated DART strategies are helping sponsors move faster with greater scientific confidence.
“DevTOX quickPredict™ has an FDA-agreed Context of Use statement and complies with the ICH S5(R3) definition of a qualified alternative assay. It is also recognized by the EPA and has supported multiple NTP and Tox21 initiatives, reinforcing its credibility as a modern NAM tool”, says Darren Kidd.
TOOLS, PLATFORMS, CALLS
7. ECHA is calling to avoid unnecessary testing on animals
Did you know that ECHA (European Chemical Agency) regularly asks for comments on testing proposals that European REACH registrants submit to the agency before they can perform new tests on animals?
You may have the scientific information that is needed to help companies avoid unnecessary testing — this is particularly important if it involves animals. ECHA currently has over 100 testing proposal consultations ongoing.
8. European Commission public consultations related to NAMs
The European Commission has launched three public consultations directly relevant to NAMs and the in silico community. These initiatives represent key opportunities to help shape policy and regulatory frameworks impacting research, innovation, and healthcare across Europe.
The open consultations are:
- Cardiovascular Health: Recommendations for evidence-based cardiovascular screening across EU Member States, focused on early detection and reducing health inequalities. Feedback open until 19 May 2026
- Medical Devices and In Vitro Diagnostics, Targeted Revision of EU Rules:A simplification of EU medical device regulations, aiming to balance patient safety with competitiveness and innovation. Feedback open until 6 July 2026
- Biotech Act: A legislative framework to accelerate the path from laboratory to market for biotech products, while maintaining high safety standards. Feedback open until 6 July 2026
To see more calls: Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
9. Roche to acquire digital pathology firm PathAI
Digital pathology can help automate manual workflows, creating digital images from physical tissue on slides. By having access to digital images, pathologists can use artificial intelligence (AI) tools for diagnostic workflows and provide faster results to patients.
PathAI makes AI models that help with the analysis of patient tissue samples and diagnostic tools. Roche has partnered with the company since 2021, expanding their agreement in 2024 to include the development of AI-enabled companion diagnostic algorithms. With the acquisition for up to $1.05B, Roche Diagnostics CEO Matt Sause said the company plans to combine PathAI’s digital pathology tools with Roche’s oncology diagnosis platforms: “Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens”.
10. ExAdEx-Innov launches its Longevity Lab
ExAdEx‑Innov just announced the launch of the Longevity Lab, a hybrid in‑silico / ex vivo platform designed to accelerate R&D in tissue longevity. Built on Human Tissue Intelligence, this new tool integrates 24 relevant endpoints of aging‑related biology and enables cosmetic, dermo‑cosmetic, and biotech teams to benchmark actives, formulations, and therapeutic strategies against a comprehensive panel of biomarkers.
ExAdEx Longevity Lab™ is now accessible online and can be used as a standalone exploratory tool or integrated with ExAdEx‑Innov’s custom services. Whether you are working on anti‑aging actives, regenerative strategies, or metabolic health‑related approaches in dermocosmetics, nutraceuticals and aesthetic medicine, the platform is designed to support innovation pipeline from target identification to claim validation.
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Engineering the BBB-on-chip: Advances in preclinical drug penetration and disease modeling
The blood-brain barrier (BBB) remains the single most significant obstacle to the successful delivery of therapeutics to the central nervous system (CNS), with over 98% of small-molecule drugs failing to penetrate the brain parenchyma.
A new review examines the emergence of BBB-on-chip technologies as a transformative solution to bridge this translational gap. The authors detail the bioengineering strategies and critically evaluate the application of these microphysiological systems (MPS) in assessing diverse therapeutic modalities. By capturing disease-specific defects such as barrier leakage and transporter dysregulation, these “disease-tuned” platforms offer unprecedented mechanistic insight into drug delivery. The authors finally discuss current translational hurdles, including material limitations and validation standards, and propose a future development where high-fidelity in vitro data are integrated with physiologically based pharmacokinetic (PBPK) modeling to enable robust in silico-in vitro extrapolation (IVIVE) for clinical prediction.
Read the review in Advanced Drug Delivery Reviews
12. Novel bioprinting method lays the foundation for personalised regenerative medicine
Bioprinting is a powerful tool for engineering living grafts, however replicating the composition, structure and function of native tissues remains a major challenge. Using 3D printing, scientists have, for the first time, simultaneously controlled the shape, type and organization of musculoskeletal tissue engineered in a laboratory to more closely mimic native developmental processes.
Concretely, they printed these cells into a support bath made of methacrylated xanthan gum which provided mechanical structure for the microtissues. Through a series of experiments, they adjusted the stiffness of the bath to the right level to optimize cell printing. Interestingly, they discovered that the shape, organization and musculoskeletal phenotype (cartilage, ligament or tendon) could be controlled by adjusting the stiffness of the support baths. This study marks a vital step forward in bioprinting and novel tissue engineering technology, but challenges remain before such tissues can be used in clinical practice.
Read more in Advanced Science News
Read the publication in Advanced Science
WORTH (RE)SHARING
Opinion piece from Helena Kandarova, ESTIV President: To Validate or Not to Validate? That Is(n’t) the Question
Podcast: Anup Zutshi, one of SPECCRO’s experts, on the power of combining NAMs
Advancing predictive modeling in Multiple Sclerosis with UISS-MS
Feedback from two days at the AI4AOP Hackathon at the Joint Research Centre in Ispra
Edition 4: BME: The Foundation of 3D Biology and Its Next Phase
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Translational Success in Inflammasome Drug Discovery: How Advanced Models and Integrated Assays Can Reduce Attrition – May 21, 2026 4:00 pm CET
In silico approaches to replace acute fish toxicity – May 28, 2026 2:00 PM — 3:30 PM CET
Integrating In Silico and Experimental Approaches in Biomedical Research: Challenges and Best Practices – May 28, 2026 3:00 PM — 4:30 PM CET
