News on non-animal methods
JANUARY 12 - 16, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Mapping existing NAM‑related training initiatives across Europe
Training and capacity building are essential for the successful regulatory uptake of New Approach Methodologies (NAMs), which is also a core focus of the NAMWISE project. CEHTRA provided for NAMWISE an important deliverable. Part of Work Package 2, the report aims to provide a comprehensive mapping and critical analysis of training and educational resources available across the European Union that are relevant to NAMs.
The purpose of this deliverable is not only to create an inventory of existing NAM-related trainings but also to evaluate their accessibility, quality, target audience, and relevance to different stakeholder groups: academia, Contract Research Organizations (CROs), industry consultants, and regulatory authorities.
2. Mapping the key US federal milestones supporting NAMs
Animal testing of drugs is often poorly predictive of safety and efficacy in humans. It also adds time and cost to the drug development process. The U.S. Food and Drug Administration and National Institutes of Health are now prioritizing the development of predictive systems that use computer modeling and in vitro organ and cell testing.
In this Policy Corner article, the authors review the foundational scientific and regulatory initiatives that are enabling the transition from animal testing to alternatives. The authors map the milestones, opportunities, and hurdles for integrating novel methodologies into regulatory policy to enhance preclinical drug development.
3. A CDER perspective: Landscape of NAMs submitted in drug development programs
This study analyzes the landscape of studies that used NAMs and were submitted to the FDA over the past 15 years. Utilizing a custom-developed Center for Drug Evaluation and Research (CDER) search tool, the investigation focused on five NAM categories, including some of those identified in the 2022 Food and Drug Omnibus Reform Act (FDORA): in vitro, in silico, in chemico, nonhuman in vivo from phylogenetically lower species, and other combined methods.
Results indicated that 93 % of NAM submissions were concentrated in two categories: in silico (49 %) and in vitro (44 %), with other categories demonstrating significantly lower representation. Despite technical limitations in the datamining work presented, the findings confirm that CDER has been receiving NAMs data in drug applications for a long time. Nevertheless, the study acknowledged that industry submits only a fraction of their NAM data to FDA, therefore the authors encouraged increased NAM submissions which would contribute to building scientific confidence in these methods.
INTERVIEWS, NOMINATIONS & AWARDS
4. NIH Grant: Novoron Bioscience’s brain organoids platform awarded
Many Alzheimer’s programs fail because traditional laboratory models cannot reflect the complexity of the human brain. Novoron Bioscience, a San Diego-based biotechnology company developing therapies for neurodegenerative diseases and neurological injury, has received a $2.5 million Small Business Innovation Research (SBIR) grant from the National Institute on Aging at the National Institutes of Health.
Novoron’s platform uses human iPSC-derived cortical organoids that capture realistic cell interactions and synaptic networks. “This award allows us to put human biology at the center of Alzheimer’s drug discovery,” said Travis Stiles, PhD, CEO and CSO of Novoron Bioscience. “Our organoid platform gives us a more reliable way to identify compounds that interrupt tau spread. We aim to generate clear, translatable data that supports rapid advancement into IND-enabling studies.”
5. New ValNAM grant for GAIN project
The GAIN (Gastrointestinal absorption integrated NAMs) project has been granted funding under the ValNAM call, funded jointly by ZonMw and the Bundesministerium für Forschung, Technologie und Raumfahrt. With partners at TNO, coordinated by Evita van de Steeg, ESQlabs will validate the combined use of the InTESTine™ in vitro model and IVIVE extrapolation approaches to predict human oral absorption and, in some cases, bioavailability and systemic exposure.
The project, coordinated by Susana Proença, Scientist Systems Pharmacology at ESQlabs, will not only address the “usual suspects”, but also chemicals whose oral absorption is driven by processes beyond passive permeability. By qualifying the integrated use of NAMs and benchmarking them against other in vitro models and PB℗K platforms, the project aims at clarifying both their applicability domains and suitable contexts of use.
Read the announcement by the project leader
6. Joseph C. Wu interview on Drug Discovery News
In a recent interview with Bree Foster from Drug Discovery News and titled “Can We Stop Using Mice for Drug Research?”, Joseph C. Wu, Director of Stanford Cardiovascular Institute, discussed the FDA Modernization Act 2.0/3.0 which will establish processes for replacing mandatory animal testing with advanced, human-relevant methods like organoids, AI, and in silico models. The Director also highlighted recent collaborative efforts with Greenstone Biosciences that resulted in multiple proof-of-concept studies using stem cells, genomics, and AI for drug discovery.
Read more and access the interview
TOOLS, PLATFORMS, CALLS
7. Call for papers in Organoid & Organ-on-a-Chip Technologies
3D organoids and microfluidic organ-on-a-chip systems are transforming disease modeling, drug discovery, and precision medicine. These advanced in vitro platforms overcome many limitations of traditional models by better recapitulating human tissue complexity and pathophysiology.
Frontiers in Bioengineering and Biotechnology is actively inviting high-quality submissions (Original Research, Reviews, Perspectives, Methods, Case Reports, and more) that explore: Next-generation microfluidic platforms and controlled organoid development; Integration of stem-cell based models for personalized and precision medicine; Disease modeling from cancer to neurological and metabolic disorders; Innovative drug screening & delivery strategies using advanced models.
Submission Deadline: 17 May 2026
Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
8. Boltz: Launch of Boltz Lab, seed round, and partnership with Pfizer
AI-powered molecular modeling is rapidly advancing, with the clear potential to revolutionize medicine by making biology programmable, digitizing experiments, and dramatically speeding up the drug development process. Boltz announced some major steps in this direction: its new small-molecule and protein design agents, the launch of Boltz Lab, a$28M seed round, and a partnership with Pfizer.
Released in beta, Boltz Lab platform focuses on model optimization to offer generous free tiers and lower costs than running open-source models yourself, representing a robust backend infrastructured. The $28M seed round is backed by Zetta, Amplify, a16z, and strategic angels, including Clement Delangue (CEO of Hugging Face), Factorial Capital, and Obvious Ventures. Boltz also announced a multi-year partnership with Pfizer to put Boltz Lab and its agents in the hands of all their scientists; and to leverage Pfizer’s data to create new state-of-the-art foundation models.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. A bioprinted model of pregnant human uterine myometrium
Despite decades of research, complications associated with dysfunctional labor are leading causes of maternal and neonatal morbidity. Currently available experimental models are not sufficient to understand the complex mechanisms underlying human labor nor to test new therapeutic approaches.
Researchers out of the University of Nevada, Reno School of Medicine sought to develop a bioprinted tissue model of pregnant human myometrium that replicates the morphological, contractile and molecular characteristics of native pregnant human uterine myometrium as a resource to accelerate basic discovery and pharmacological testing. Further development of this model could provide an abundant and homogeneous tissue source to facilitate mechanistic studies and test agents to modulate labor.
Read the publication in Frontiers
10. Rethinking how we model Alzheimer’s disease
Traditional nonclinical models of Alzheimer’s disease (AD), such as monolayer cell cultures and transgenic mice, struggle to capture the complexity of the disease as it occurs in humans. Human-centered complex in vitro models (CIVMs), including cerebral organoids and microfluidic organ-on-a-chip (OOC) technologies, provide greater physiological relevance by more closely recapitulating key cellular and molecular features of the human brain and disease mechanisms.
Beyond the amyloid hypothesis: leveraging human-centered complex in vitro models to decode Alzheimer’s disease etiology
In a new mini review, researchers evaluate recent advances in CIVMs and how they are being leveraged to investigate emerging hypotheses of AD etiology. They also highlight early efforts to model the gut – brain axis using organoid and multi-OOC systems, demonstrating how microbiota-derived factors can affect neural processes. Collectively, these studies show that human-centered CIVMs can be applied to both recreate and mechanistically disentangle interrelated pathological processes to an extent beyond that afforded by animal models, thus offering new opportunities to identify causal mechanisms and potential therapeutic targets.
Read the publication in Frontiers in Toxicology
Modeling neurovascular dysfunction in AD using an isogenic brain-chip model
Emulate shared a new publication from its CRADA (Cooperative Research and Development Agreements) collaboration with a neurotoxicology team at the U.S. FDA. In this study, the research team developed a human-relevant, iPSC-derived Brain-Chip model of the neurovascular unit to investigate neurovascular dysfunction associated with AD. The model enabled direct interrogation of AD patient-derived BBB biology — revealing barrier impairment, inflammatory signaling, and vascular tau accumulation. The study is another step in a multi-year effort with FDA scientists to build confidence in Organ-on-a-Chip technology as a rigorous, human-relevant tool for drug discovery and development
11. Human 3D multicellular live spheroid to identify hepatotoxic compounds
Despite progress, many drugs fail because toxicity is missed during preclinical testing. In vitro liver cell models are therefore continuously evolving in order to investigate hepatic functions and assess drug-induced liver toxicity more efficiently. 3D cell models have recently emerged as superior to 2D systems.
In a recent study, researchers presented a human multicellular liver spheroid comprising hepatocytes, cholangiocytes, stellate cells, and immune cells, and designed to closely mimic liver physiology for toxicological studies. A dedicated workflow was also developed for analyzing 3D-reconstructed images, enabling robust biomarker assessment. This advanced 3D liver model is a promising tool for identifying hepatotoxic compounds and their mode of action in a human-relevant context.
Read the publication in the NAM Journal
WORTH (RE)SHARING
Lab-grown “tiny brains” from patient derived stem cells are starting to distinguish schizophrenia and bipolar disorder based on their neural activity patterns in the dish
Identifying mode of action and increasing confidence in the in vitro Point of Departure for NGRA
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
NURA Training “The FDA ISTAND Program: A Guide to Replacing Animal Experiments with Your Method”
28 January, 2026. Presenter: Michael Phelan, Founder of InnovApproach Consulting
Sign up to the 4th edition of the Stem Cell Summer School
Radboudumc, Nijmegen: 22 – 26 June 2026
