NAMs News
SEPTEMBER 07 - 11, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. EMA: New voluntary data submission pilot to advance innovative alternatives to animal testing
EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). This pilot is part of EMA’s efforts to foster the regulatory acceptance of NAMs by enabling regulators to gain experience with these approaches and assess their scientific value in a regulatory context.
Ultimately, this initiative aims to strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. It builds on EMA’s longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation.
2. U.S EPA: Two major scientific advancements to replace animal testing for chemical reviews
U.S. Environmental Protection Agency (EPA) announced two major scientific advancements designed to modernize safety reviews of new chemicals and pesticides while further eliminating the agency’s reliance on animal testing. The new methods will help EPA assess the potential inhalation and oral risks of certain chemicals and pesticides faster and with greater human relevance, advancing the agency’s commitments to transparency, regulatory certainty, and the protection of human health and the environment.
Two integrated NAMs solutions are:
- EPA has updated its scientific framework to better predict how surfactant specific formulas may irritate the lungs using 3D human airway tissue, providing science that is faster, more human relevant, and less dependent on animal testing — without compromising safety.
- EPA will use an international, scientifically backed formula, the Globally Harmonized System (GHS) mixtures equation, to predict oral toxicity for some pesticides. This decision follows a comprehensive analysis — conducted with the National Institute of Environmental Health Sciences — that evaluated nearly 700 pesticide formulations.
3. Frozen time: How 3D printing could create the first biological supply chain
In a new online article, Charles G. Goulding explores how 3D printing and cryogenic preservation could transform organ transplantation by creating the world’s first biological supply chain.
Researchers are exploring cryogenic preservation, particularly vitrification, to extend this window. However, freezing and warming complex organs such as kidneys is difficult because their delicate cells, blood vessels, and internal structures can be damaged by ice formation, chemical toxicity, or uneven temperature changes. The author connects these advances to 3D bioprinting – with technologies such as SWIFT, CELLINK, and microfluidic bioprinting – which could allow engineers to design tissues with vascular networks and structures specifically optimized for preservation, storage, and later use.
4. NAMs without context of use slow EU adoption
In a new Trends in Biotechnology article, FRESCI founder Marco Straccia, and Milena Mennecozzi, Project Officer at the European Commission’s Joint Research Centre (JRC), argue that NAM is best understood as a regulatory-ecosystem term, not as a product category or a blanket synonym for advanced biotechnology. A methodology’s regulatory meaning is defined by its intended context of use (CoU).
Context of Use is neither an administrative afterthought nor a substitute for scientific validity. It is the frame that turns general requirements into decision-specific evidence standards. Without a specified endpoint, product class, development stage, intended role, comparators, performance criteria, and acceptable uncertainty, fitness for purpose — and the appropriate route to validation, qualification, or evidentiary use — remains unclear.
INTERVIEWS, NOMINATIONS & AWARDS
5. Organ-Chips reach new frontiers with AVATAR and next-gen preclinical testing
In a SelectScience® article, Dr. Lorna Ewart, Chief Scientific Officer at Emulate, and Dr. David Benson Chou, Principal Investigator, discuss how the field is evolving, how Emulate’s AVA™ Emulation System is helping address adoption challenges, and why Organ-Chip ‘avatars’ are now even being sent into space.
“This project shows Organ-Chips can be deployed to model human biology in one of the most challenging research environments imaginable,” says Chou. “The collaboration reflects the growing confidence in these systems as predictive, human-relevant models, not only for drug development on Earth, but for understanding human health in extreme environments.”
TOOLS, PLATFORMS, CALLS
6. Help shape the future of NAM Education: Participate in the ERA4NAMs Survey
The ERA4NAMs Working Group on Education and Training is inviting researchers, educators, regulators, and other stakeholders to contribute to a European-wide survey on education and training in NAMs.
The results will help create a comprehensive overview of the current NAM education and training landscape and inform future recommendations to strengthen NAM-related skills, workforce development, and capacity building across the European Research Area. The deadline to fill the survey is 15 September 2026.
INDUSTRY, BIOTECH & PARTNERSHIPS
7. Danish 3D cell culture company Celvivo raises USD 6.6 million and appoints new CEO for global scale-up
Danish biotech company Celvivo adds an industry-veteran investor to its ownership circle and, with its ClinoStar platform for 3D cell cultures, continues to build towards becoming a leading provider reshaping the future of life-science research.
“We operate in a rapidly developing market with a large, untapped potential when it comes to the technologies presently being used. With this new investment, we have a decisive opportunity to turn our potential into reality. It’s a strong vote of confidence as we enter the next stage of Celvivo’s growth and scale-up journey,” said Jacob Philipsen, CEO of Celvivo.
8. ExAdEx-Innov reaches a new milestone with the granting of a US patent
Supported by Université Côte d’Azur’s IdEx Innovation Programme, deeptech start-up ExAdEx-Innov has been granted a U.S. patent for its innovative ex vivo human tissue models.
Emerging from research at Université Côte d’Azur’s Institute of Biology (iBV), ExAdEx-Innov develops human tissue models for the pharmaceutical, cosmetics, and biotechnology industries. This patent strengthens the company’s international development and intellectual property portfolio, highlighting the successful transition from academic research to protected, market-oriented innovation.
Read more (FR)
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. TME-On-Chip project: A new ultra-personalized technology to guide therapeutic decisions
Tumor-on-chip models are part of the 3D tumor modeling approaches developed within the PEPR MED-OOC: functional tests that assess treatment efficacy and predict how patients will respond to different therapeutic molecules. This technology has been validated for patients with metastatic breast cancer by several teams from Institut Curie and the CNRS. Compared against reference PDX models (using mice), the ex vivo tests correctly identified drug sensitivity in 88% of cases and resistance in 91% of cases, with no false positives at clinically relevant drug concentrations.
Published in Cell Reports Medicine on 28 August 2026, their proof-of-concept results lay the foundations for a clinical trial led by Institut Curie which should start in 2027, paving the way for a shift in clinical practice regarding patient care.
Learn more with Institut Curie
Read the article in Cell Reports Medicine
10. Light speeds up maturation of human mini-retinas
Retinal organoids usually develop in the dark in laboratories. Their slow development and maturation remains an important limitation. It typically takes around 240 days or longer for retinal organoids to develop relatively mature photoreceptors. This makes experiments lengthy and costly and can slow down research into new treatments. Yet the retina’s natural function is to detect light.
Researchers from Radboudumc and international collaborators therefore asked a simple question: could exposing these mini-retinas to light help them mature? Two independent studies, published in Communications Biology and Nature Communications, show that controlled light exposure promotes the maturation of photoreceptor cells in retinal organoids. The findings could help researchers develop better human models for studying retinal diseases and testing new treatments.
Read the study in Communications Biology
Read the study in Nature Communications
11. Human iPSC-derived vascularised lung organoids for modelling COPD and pulmonary hypertension
In a new study, researchers developed a reliable method to make vascularised lung organoids (vLOs) containing different lung cell types and functional blood vessels. They then used these models to study chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH).
The patient-derived vLOs successfully reproduced important features of these diseases. Cigarette smoke extract caused lung damage and inflammation similar to COPD, while PH-derived vLOs showed abnormal changes in blood vessels. Overall, these vLOs could be useful for studying lung diseases, understanding disease mechanisms, and testing personalized treatments.
12. How the developing human brain takes instructions: Two UCLA studies reveal what guides its most important stem cells
Findings published in Cell and Science uncover metabolic and physical cues that influence which cell types radial glia produce in the developing human cortex. UCLA researchers used lab-grown brain organoids, donated human tissue and fused “assembloids” to investigate how radial glia — the stem cells that build the human cerebral cortex — decide which types of brain cells to make.
One study showed that how neural glia process nutrients helps determine which neurons they make. The other showed that physical contact from a neighboring region — the thalamus — drives the same cells to produce more of the neurons most expanded in the human brain. Together, the findings recast radial glia’s surroundings — its nutrients and physical connections — as active drivers of human brain development, offering new insight into how the cortex is built and how that process can go awry in neurodevelopmental disorders and cancer.
WORTH (RE)SHARING
OECD’s Test Guideline Programme adopts ICAPO-led project on nonanimal respiratory irritation
The CoU Qualification Phase – A perspective from Reyk Horland, CEO at TissUse GmbH
You’re a scientist based in France? Don’t forget to take the national survey on the use of alternative approaches to animal testing – the deadline is October 1st
The NC3Rs Releases the DRIVER Recommendations: Improving the quality of In vitro research
Discover ESTIV Best Oral Presentation Award at the VPH2026 Congress in Milan
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Why Connected Research is the Next Frontier in Discovery – September 16, 4:00 pm — 5:00 pm (CET), online
First edition meeting on iPSC-derived microglia – September 18, in Groningen (The Netherlands)
Mini-Symposium on NAMs for Preclinical HIV Research – September 18, 12:00 noon – 4:00 p.m. EDT, online
ESTIV x L’Oréal Applied Training Course – September 20 – 26, St-Ouen (France)
