News on non-animal methods
APRIL 13 - 17, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. ICH S7A revised after 25 Years: Why it matters for NAMs developers
The International Council for Harmonisation (ICH) S7A guideline on safety pharmacology studies, finalized in 2000, has been pivotal in protecting clinical trial participants and patients from adverse effects of pharmaceuticals. In parallel, technological innovations with the emergence of New Approach Methodologies (NAMs), have expanded opportunities to enhance human-relevant risk assessment and reduce reliance on animal testing.
To explore priorities for modernizing the guideline, a multi-stakeholder workshop was convened in Brussels in February 2026, bringing together representatives from industry, trade associations, regulatory agencies, contract research organizations, and non-governmental organizations. Collectively, discussions support the development of a modernized, risk-based framework for safety pharmacology that maintains robust protection of human subjects while enabling innovation, global regulatory harmonization, and implementation of the 3Rs principles.
2. U.S: FDA CDER and OND experience with NAMs
The U.S. FDA Center for Drug Evaluation and Research (CDER), and Office of New Drugs (OND) has continuously encouraged the submission of nonclinical tests utilizing NAMs. In 2020, a FDA/CDER perspective on nonclinical testing strategies was published, discussing the opportunities and challenges of using NAMs in drug development, and reporting gaps and challenges.
A new editorial article provides a CDER/OND Pharmacology/Toxicology reviewer perspective on NAMs submitted to support new drug development, and on the future of NAM incorporation into nonclinical development programs for new drugs as scientific technology continues to evolve. Ultimately, the authors provide considerations for refining NAM submissions by (1) illustrating their scientific approach to evaluating NAM submissions; (2) reiterating FDA/CDER’s steadfast commitment to the 3Rs; and (3) fostering confidence in their continued efforts to encourage nonclinical test NAM submissions for regulatory decision-making, while maintaining their mission to protect public health and patients from unintended harm.
3. Never-ending Acronym Madness: Proposing a harmonized definition for NAMs
As scientists, regulators, and policymakers increasingly seek to reduce reliance on animal testing, “NAMs” are gaining attention. However, the acronym is used inconsistently, referring to New Approach Methodologies, Non-Animal Methods, and differing sets of technologies.
This lack of clarity risks confusion, misaligned expectations, and inflated claims of progress. A new position paper proposes a harmonized, goal-oriented definition applicable across sectors and based on specific criteria: “New Approach Methodologies (NAMs) are technologies that do not directly involve live animals and generate mechanistic or predictive information to advance biological understanding or inform decisions related to human, animal, or environmental health. They typically rely on target species’ data, cells, tissues, or computational approaches. These technologies may, but do not always, contribute to the 3Rs of animal research”.
4. Human skin-on-a-chip: The ENVOL « France 2030 » project
The ENVOL (Epidermis Neurone Vascularization On digital Library) project, supported by France 2030, was launched on March 12 in Auvergne-Rhône-Alpes. It aims to develop a model of innervated human skin-on-a-chip, a still-emerging approach, at the crossroads of biology and engineering, that could ultimately transform industrial practices.
With funding of 2 million euros, it brings together public and private stakeholders around a common goal: developing a model of reconstructed human skin, integrating both immune functions and innervation on a microfluidic chip. ENVOL seeks to enrich these approaches by combining immune response and neuronal tissue activity. The objective: to measure electrophysiological activity and produce a “digital signature” of skin reactions.
5. OOC AVATARs for astronaut health in space
Launched on April 1, 2026, Artemis II is a historic, approximately 10-day lunar flyby mission that sent four astronauts farther into space than any humans have traveled since the Apollo era, marking a critical step toward sustained lunar exploration and future missions to Mars.
The Wyss Institute for Biologically Inspired Engineering at Harvard University is playing a pivotal role in the Artemis mission through its groundbreaking contributions to the AVATAR (A Virtual Astronaut Tissue Analog Response) investigation. The AVATAR experiment could represent a paradigm shift in how space agencies study human health risks beyond Earth’s protective magnetosphere by leveraging human Organ Chip (OOC) technology.
INTERVIEWS, NOMINATIONS & AWARDS
6. Andrew Gaffney: Top 20 Under 40 in Life Sciences for 2025
Andrew Gaffney, Vice President of the iPSC Platform at STEMCELL Technologies, has been named one of Canada’s Top 20 Under 40 in Life Sciences for 2025 by Catalytic Health and Bedford Group/TRANSEARCH. This recognition highlights his leadership in advancing the commercialization and strategic growth of induced pluripotent stem cell (iPSC) technologies, which are transforming applications such as disease modeling, drug discovery, toxicity testing, and regenerative medicine.
Dr. Gaffney has played a pivotal role in driving the global adoption of high-quality iPSC platforms, enabling thousands of researchers worldwide. A strong advocate for ethical standards, quality, and transparency in stem cell research, he has contributed to numerous committees and initiatives and was also recognized with the International Society for Stem Cell Research (ISSCR) Public Service Award in 2025.
TOOLS, PLATFORMS, CALLS
7. Computational modeling of hormone homeostasis research opportunity announcement
The NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) have released a Research Opportunity Announcement (ROA) on “Computational Modeling of Hormone Homeostasis,” seeking innovative, early‑stage in silico approaches to model hormone‑mediated biological processes and improve sex‑specific drug assessment.
With significant community involvement and input, this initiative will advance the development of in silico computational approaches that model and simulate human hormone homeostasis, with an emphasis on applicability to sex-specific efficacy and toxicity evaluation of therapeutics. Letters of Intent (LOI) due date: April 24, 2026.
Interested in applying? Check out the technical assistance webinar
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SCIENTIFIC DISCOVERIES & PROTOCOLS
8. Personalized cellular modeling and deep phenotyping in Schizophrenia
Schizophrenia is a severe and difficult to treat mental disorder affecting around one percent of the population worldwide. Current treatments are unable to treat negative symptoms (i.e., lacking motivation and social withdrawal), or cognitive symptoms (i.e., problems with attention or memory) which determine the long-term functional outcome of patients.
In a study recently published in JAMA Psychiatry, Florian Raabe, Michael Ziller and their teams combined magnetic resonance imaging (MRI), electroencephalogram (EEG) and cognitive testing data from over 400 patients and healthy controls with data on gene expression and synaptic density, based on iPSC-derived neurons generated from blood samples from 80 donors within this larger cohort. With this approach, they showed that the level of synaptic impairment seen in stem cell-derived neurons of schizophrenia patients, predicted their level of cognitive impairment.
Read the article in JAMA Psychiatry
9. Neural induction quality control as a key to reproducible MEA-based neurotoxicity assays
Human induced pluripotent stem cell (hiPSC)-derived neural models combined with microelectrode array (MEA)-based readouts are increasingly used in next-generation neurotoxicity assessment. However, neural induction of hiPSCs into multipotent neural progenitor cells (hiNPCs) remains highly variable, and current quality control (QC) efforts focus largely on the pluripotent starting material.
A new study shows that hiPSCore,a machine-learning-based classifier for early cell-fate decisions, reliably distinguishes successful from unsuccessful neuroectodermal inductions at early stages (days 6 – 12). Inductions passing these early QC checkpoints generated BrainSphere-derived networks with reproducible MEA maturation trajectories, balanced neurotransmitter-responsive unit distributions, and conserved subtype-specific pharmacological responses. Together, these findings describe an adaptable QC framework that allows early termination of failed inductions, reducing resource burden, and strengthening confidence in hiPSC-based neural network assays for neurotoxicity testing.
Read the article in NeuroToxicology
10. Human microphysiological systems of aging recreate the in vivo process
In a first-of-its-kind study published in Nature Biomedical Engineering, current and former UC Berkeley scientists detail a way to accelerate the biological age of human fat and liver tissues using a miniaturized organ-on-a-chip system.
In as little as four days, researchers were able to mimic — with high physiological accuracy — roughly 40 years of aging on tissue derived from induced pluripotent stem cells. This new technology could make it easier for researchers to understand aging mechanisms and screen longevity therapeutics without waiting years for results.
Read the article in Nature Biomedical Engineering
11. Mini models of the human brain are revealing how this complex organ takes shape
The development of the human brain, with its extraordinary range of cognitive abilities, is an awe-inspiring feat of evolution. None of this is easy to study. Conventionally, scientists have relied on animal models and scarce human brain tissue. But the advent of tiny laboratory-grown models of human brains called organoids has transformed their options.
A new feature in the prestigious journal Nature highlights these new tools, and how they are turbo-charging the study of human brain development and disease.
WORTH (RE)SHARING
Can organoids model human brain development? Two papers from the last couple of days dive deep into this question – by Sam Lloyd-Button, PhD
Discover the innovations that turned 3D fabrication into tools for building complex, lifelike biological structures – Milestone from DDN
Siloed data is one of the biggest obstacles in computational toxicology – by Flower Labs
NAM TPI Award for cardiovascular research – deadline on May 1st, 2026
Call for book chapters on OOC
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
NAMs Technology Partn3Ring webinar series – Wednesday 22 April, 14.00 – 15.15 (BST), Online
