News on non-animal methods
DECEMBER 15 - 19, 2025
NEWS, REPORTS & POSITION STATEMENTS
1. Opportunities and insights from pharmaceutical companies on the current use of NAMs in nonclinical safety assessment
To foster broader adoption of NAMs, the Biotechnology Innovation Organization surveyed pharma/biotech companies about NAM usage and collected 22 case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment.
Despite successes with NAM-based global regulatory filings, there are concerns from companies about global regulatory harmonization and clinical translatability. NAMs have the potential for greater uptake with enhanced guidance and industry – regulatory agency collaboration being key to their adoption. The manuscript also presents some case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced NHP studies for safety assessment.
Read more in Drug Discovery Today
2. EMA welcomes political agreement on new EU pharmaceutical legislation
The European Commission, European Parliament and Council of the European Union reached an agreement on the new pharmaceutical legislation. This once‑in‑a‑generation reform will: 1/ Enhance patient access to medicines; 2/ Strengthen supply security across the EU; 3/ Boost innovation through streamlined processes and digitalisation.
Building on years of commitment to European patients, this reform represents a key step in advancing healthcare across the EU. “The revamp of the pharmaceutical legislation will enable EMA and the European medicines regulatory agencies network to become more agile and efficient while upholding the highest standards of scientific rigour. The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats”, declared Emer Cooke, EMA’s Executive Director.
3. Horizon Europe: €14 billion to boost global research and innovation leadership
The European Commission adopted the main Horizon Europe work programme for 2026 – 2027, a €14 billion investment designed to drive research and innovation (R&I) across the EU’s strategic goals. These goals include achieving climate neutrality, boosting the use of artificial intelligence (AI) in research and innovation, and ensuring resilience in a rapidly changing world.
To achieve this, the programme introduces new cross-disciplinary calls and topics that will boost decarbonisation and the use of AI in research. It also expands the ‘Choose Europe’ initiative to attract global talent and makes applying for Horizon Europe funding and participation simpler.
INTERVIEWS, NOMINATIONS & AWARDS
4. ARPA‑H Contracts: Revalia Bio & Deep Origin awarded
Revalia Bio awarded to advance drug development with human data trials
Revalia Bio, developer of the Human Data Trial platform announced that they are serving as the technical lead for an up to $26.7M contract that they were awarded under the Advanced Research Projects Agency for Health (ARPA‑H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. The project, titled An Integrated Human Data Approach to Unlock the Future of In Silico Learning Models, supports Revalia’s mission to redefine how drug safety and efficacy are predicted before clinical trials. Revalia will lead the effort to build advanced AI-driven models trained on Human Data Trials, living systems derived from donated human organs, organ-on-chip platforms, and multimodal datasets.
Deep Origin awarded to build in silico models to replace animal testing
Deep Origin and its partners in the Pharmacological Research and Evaluation through Digital Integration and Clinical Trial Simulation (PREDICTS) consortium have also been awarded an up to $31.7 million contract from the ARPA‑H CATALYST program. Through the CATALYST program led by ARPA‑H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D, Deep Origin is developing in silico and ex vivo systems to better predict drug safety and dosing, and reduce the use of slow, costly, and lower-accuracy animal studies beforeclinical trials ever begin.
5. ValNAM “Inter-laboratory Validation of ReproTracker” proposal selected for funding
“Inter-laboratory Validation of ReproTracker”, ValNAM platform funded by ZonMw and the Bundesministerium für Bildung und Forschun, will help bring ReproTracker* one step closer to regulatory acceptance, announced Amer Jamalpoor, PhD, ERT, Chief Scientific Officer, at Toxys. This achievement reflects the dedication, innovation, and collaborative spirit of the many involved, among others: Unilever, Bundesinstitut für Risikobewertung, Ombion Centre for Animal-free Biomedical Translation, DNTOX GmbH.
*ReproTracker® is a state-of-the-art human stem cell-based in vitro assay that rapidly and reliably identifies developmental toxicity hazards of new drugs and chemicals. Earlier in October, Charles River Laboratories International, Inc. and Toxys announced a collaboration that offers Charles River’s clients access to ReproTracker®.
Read the announcement on Linkedin
TOOLS, PLATFORMS, CALLS
Check out the NAM calls interface
6. Global Exposome Summit: Call for abstracts
The growing number of human exposome research programmes and projects in recent years has boosted research output and led to the creation of new initiatives and infrastructures worldwide. To bridge the gap of stronger cooperation, the International Human Exposome Network (IHEN) and the Global Exposome Forum (GEF) are joining forces to organise the Global Exposome Summit 2026. The Global Exposome Summit 2026 will take place in Sitges (Barcelona, Spain) in April 2026 and will bring together researchers, policymakers, industry, funders, and other stakeholders working on advancing human health through exposome research and practice.
The Scientific Committee now invites abstracts describing ongoing and completed work related to the human exposome and exposomics. Abstract submission deadline is 6th January 2026.
Read more and submit your abstract
INDUSTRY, BIOTECH & PARTNERSHIPS
7. EMMI: Terray’s experiment-driven machine learning platform for small-molecule discovery
Terray Therapeutics introduced EMMI—Experimentation Meets Machine Learning — as an integrated platform that pairs ultra-dense microarray experimentation with a full AI stack used daily across its discovery programs. The company reports more than 13 billion proprietary compound-target measurements generated through its microarray system, expanding by roughly 1 billion per quarter.
At the center of Terray’s AI platform is COATI, a large-scale molecular foundation model that gives algorithms a way to understand and design molecules in the same way language models process text. Trained on more than one billion molecular structures, COATI links multiple chemical representations that allows the system to move seamlessly between understanding and generating molecules with specific properties.
SCIENTIFIC DISCOVERIES & PROTOCOLS
8. Infecting human brain organoids with FFI or sCJD
Prion diseases, such as sporadic Creutzfeldt-Jakob Disease (sCJD), are neurodegenerative disorders caused by misfolding of the prion protein (PrP). The D178N mutation in the PrP gene causes Fatal Familial Insomnia (FFI). Several transgenic mouse models spontaneously develop FFI signs and pathology, but these vary in their ability to reproduce all aspects of FFI, including transmissibility. With the limitations of mouse models, there is a need for models that more closely recapitulate the human host environment.
A new study showed that both sCJD and FFI prions can infect human cerebral organoids with or without the D178N mutation. The data supported that not only are organoids able to propagate both sCJD and FFI prions, retaining the seeding substrate preference of the original infecting inoculum, but also that the inoculating prion is the primary factor driving the formation of the misfolded prions, overriding the presence or absence of the FFI causing mutation. The study also provided a new model for studying FFI in a human brain tissue homolog.
9. Study dysfunction in pediatric ulcerative colitis with patient-derived colon epithelial organoids
Ulcerative colitis (UC) is associated with epithelial metabolic derangements which exacerbate gut inflammation. A recent study developed colon organoid (colonoid) lines from pediatric patients with endoscopically active UC, inactive UC, and those without intestinal inflammation to interrogate functional metabolic differences in the colon epithelia.
Researchers demonstrated that active UC colonoids exhibit hypermetabolic features and cellular stress, specifically during differentiation. Collectively, their findings identify lipid-related metabolic dysfunction as a key pathologic feature of the pediatric UC epithelium and highlight the potential of patient-derived colonoids as a preclinical model for evaluating epithelial-targeted therapies addressing this dysfunction.
Read the publication in Nature Communications
10. Cell-type deconvolution methods for spatial transcriptomics
Spatial transcriptomics is a powerful method for studying the spatial organization of cells, which is a critical feature in the development, function and evolution of multicellular life. However, sequencing-based spatial transcriptomics has not yet achieved cellular-level resolution, so advanced deconvolution methods are needed to infer cell-type contributions at each location in the data. Recent progress has led to diverse tools for cell-type deconvolution that are helping to describe tissue architectures in health and disease.
A recent review described the varied types of cell-type deconvolution methods for spatial transcriptomics, contrast their capabilities and summarize them in a web-based, interactive table to enable more efficient method selection
Read the study published in Nature Review Genetics
11. Interlaboratory Validation of the Human Thyroid Microtissue Assay
The U.S EPA continues to evaluate strategies to implement new approach methods (NAMs) for screening chemicals that disrupt the thyroid endocrine system. Validation of NAMs is a critical milestone toward establishing confidence in data sources that could be used in a regulatory decision-making context. A study has been conducted with the aim of presenting an interlaboratory validation of the human thyroid microtissue assay to evaluate its relevance and reliability.
In coordination with the U.S. validation authority, NICEATM, and collaboration with industry partners (LifeNet Health, Bayer Crop Science, Corteva Agrisciences), the study aims were to 1) define the study design and establish standard operating procedures, 2) conduct test method transfer, training, and within-laboratory model performance evaluation, 3) perform interlaboratory reference chemical testing and assay performance evaluation.
Read more in Toxicological Sciences
WORTH (RE)SHARING
MPS World Summit: Deadline to submit your abstract: Jan. 11, 2026
Ombion Center 1st conference — Designing the Future Through Patient-Based Drug Development: Jan. 26, 2026
Summer Immersion on Innovative Approaches in Science
Johns Hopkins Bloomberg School of Public Health, Baltimore, June 15 – 18, 2026: Apply by April 3
