NAMs News
November 02 - 06, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. The economics of NAMs: Promise, costs, and the challenges of adoption
Beyond their scientific and ethical benefits, New Approach Methodologies (NAMs) are often presented as a potentially cost-effective alternative to conventional approaches. However, assessing their economic value requires looking beyond the price of individual experiments, taking into account initial investments, implementation challenges, regulatory acceptance, and their potential to improve research efficiency.
A new blog on Johns Hopkins University Toxicology Policy Lab website explores the economic opportunities and challenges associated with the transition to NAMs, examining whether these technologies can reduce research and development costs, prevent costly failures, and deliver long-term financial benefits. It also considers the role of regulatory developments and public investment in accelerating their adoption, highlighting why their economic value should ultimately be measured not simply by how much they cost, but by the quality and relevance of the scientific information they generate.
2. Animal method bias in publishing: Environmental Toxicology and Pharmacology just updated its aims and scope
The Coalition to illuminate and Address Animal Method Bias (COLAAB) just announced that under the leadership of Editor-in-Chief, Michael D. Coleman, the journal Environmental Toxicology and Pharmacology just updated its aims and scope to be more supportive of NAMs submissions—and hopefully help prevent animal methods bias. This is the second journal to take definitive action against animal methods bias, following in the footsteps of the journal Toxicology back in July.
“Whilst Environmental Toxicology and Pharmacology recognises that animal studies remain an intrinsic part of scientific research, the Journal is strongly in favour of submissions which feature human and in silico-based new approach methods (so-called NAMs). Of course, all submissions will be evaluated in line with current best scientific practice, but it is important to note, that Environmental Toxicology and Pharmacology does not require animal-based validation of NAMs.”
3. NIH: A technology development center uses human-based models to discover potential treatments for fibrotic diseases
Led by Marc Ferrer at NCATS and Darlene Dixon, at the National Institute of Environmental Health Sciences (NIEHS), the 3D MultiOrgan Models of Fibrosis (3D-MOFIB) technology development center, funded by NIH’s $150 million investment through the Complement-ARIE program, is developing human-based models to better understand fibrotic diseases and accelerate the discovery of potential treatments.
Marc Ferrer, director of NIH’s 3-D Tissue Bioprinting Laboratory, emphasized the importance of finding treatments for fibrosis. “Fibrotic diseases are the cause of high morbidity and mortality worldwide. It affects a lot of people — almost 1 in 4 people. There are just a couple of approved treatments that target the underlying causes of tissue scarring and do not work for all fibrotic disease.”
4. Knowledge infrastructure supporting next generation risk assessment
The transition toward Next Generation Risk Assessment (NGRA) and the increased use of NAMs require robust knowledge infrastructures capable of integrating diverse experimental and computational data into transparent, reproducible, and regulatory-relevant workflows. However, toxicological data remain highly fragmented across heterogeneous sources, limiting interoperability, reuse, and the development of predictive models.
A new paper describes the design, implementation, and deployment of a FAIR-compliant (Findable, Accessible, Interpretable and Reproducible) knowledge infrastructure developed within the RISK-HUNT3R project to support integrated data management, computational modelling, and mechanistically informed risk assessment. This work demonstrates how FAIR-compliant knowledge infrastructure can enhance computational toxicology by improving data quality, interoperability, and reproducibility, while providing a scalable foundation for integrating NAMs, artificial intelligence, and mechanistic modelling into next-generation safety assessment.
INTERVIEWS, NOMINATIONS & AWARDS
5. EHFG 2026: Health for a stronger European Union
From 29 September to 2 October 2026, the European Health Forum Gastein (EHFG) held a hybrid conference in Gastein and online on the topic “Health for a stronger European Union”.
The session “Securing Europe’s access to future medical breakthroughs” brought together policymakers, patient and industry representatives to discuss the choices needed to strengthen Europe’s position in medical research and ensure patients benefit from innovation.
Access the conference programme
TOOLS, PLATFORMS, CALLS
6. NIH Notice of Funding Opportunity: Translational centers using MPS for infectious diseases
A new NIH Notice of Funding Opportunity (NOFO) was recently published. RFA-AI-28-012: Translational Centers Using Microphysiological Systems for Infectious Diseases, seeks to establish a consortium of specialized research centers that use human cell-based microphysiological systems (MPS) to model infectious diseases and accelerate the development of medical interventions.
This funding opportunity is open to U.S. for-profit, nonprofit, and governmental organizations and is motivated by recent NIH and FDA initiatives in NAMs that can better reflect human biology while reducing reliance on animal studies. To meet this need, the Translational Centers will refine validated human tissue models studying infectious diseases to a level consistent with regulatory qualifications that will promote their adoption for use by product developers, supporting regulatory acceptance. Applications will be accepted from December 29, 2026, though January 29, 2027; funded projects are expected to begin in January 2028. The maximum project period is 5 years.
INDUSTRY, BIOTECH & PARTNERSHIPS
7. Boehringer Ingelheim and Microsoft are collaborating on patient-centered, AI-driven clinical development
Boehringer ingelheim and Microsoft have announced a strategic collaboration. The goal is to use artificial intelligence (AI) to help make safe and effective therapies available to patients more quickly. The collaboration focuses on joint research into the potential of so-called “Digital Patient Twins”—computer-generated representations of individual patients. These models use clinical and other relevant data to predict how disease progression and treatment outcomes might unfold under various scenarios.
The partnership also includes the modernization of security and data center infrastructures, thereby supporting the establishment of a secure, resilient, and future-proof technological foundation for AI-driven innovations. Together, the companies will explore potential development projects in other areas, including animal health, business processes, and technology infrastructure.
SCIENTIFIC DISCOVERIES & PROTOCOLS
8. Human-on-a-Chip models of female and male reproductive systems for research and testing
Two studies demonstrate how organ-on-a-chip technology is addressing these challenges in female and male reproductive health research. By combining human tissues with devices that mimic the body's natural environment, researchers have developed more realistic models of the female and male reproductive systems.
The first study, led by researchers from Gachon University (Incheon, South Korea) and Hallym University College of Medicine (Chuncheon, South Korea), described an ovary-endometrium-on-a-chip that recreates communication between the ovary and uterus. The second study, led by researchers from Naval Medical University (Shanghai, China) and Nanjing University (Nanjing, China), tackled another long-standing challenge in reproductive medicine: maintaining healthy human testicular tissue outside the body to investigate male reproductive biology. They developed a human testis-on-a-chip that continuously supplies nutrients and oxygen to human testicular tissue while removing waste products, closely mimicking blood flow in the body.
9. A microgravity enhanced disease organoid model for drug screening and mechanistic studies to improve treatments for glioblastoma
Creating accurate organoid models remains a challenge, particularly for diseases like glioblastoma (GBM), an aggressive, treatment-resistant brain cancer with an immunosuppressive microenvironment.
A new study reports the development of an enhanced disease model for drug screening and mechanistic studies to improve treatments for GBM. Growing glioblastoma organoids in the microgravity conditions of the International Space Station induces transcriptomic, proteomic, and spatial organization and morphological alterations that render the space-grown organoids to more accurately recapitulate advanced, aggressive human disease than organoids grown under Earth’s gravity.
10. Deep Visual Proteomics enables the spatially resolved analysis of proteins in tissues and a better understanding of disease processes
In proteomics research, a method called Deep Visual Proteomics (DVP) helps scientists determine the amount of proteins in individual cells while simultaneously identifying where these cells are located within the tissue. A team led by Dr. Fabian Coscia, head of the “Spatial Proteomics” research group at the Max Delbrück Center, has now developed the first open-source tool for a holistic workflow: “openDVP” is designed to simplify the application of this—further optimized—technology and make it accessible to a wider group of users.
The method is not limited to specific diseases but can be applied to biological samples of any kind. To demonstrate the technology’s capabilities, the researchers analyzed and characterized the spatially resolved proteomes of cells in three different tissue samples: from a placenta, a lung adenocarcinoma, and a breast tumor. “We selected these samples to demonstrate the versatility of our method. They allow us to illustrate how the technique can provide unique insights into the function of proteins in various cellular environments that have been largely unexplored until now,” says Coscia.
Read the article in nature methods
11. Programmable apoptosis circuits enable subtractive engineering of stem cell-derived organoids and embryoids
Pluripotent stem cell (PSC)-derived multicellular systems provide a promising platform for studying development and disease. However, they do not faithfully mirror their in vivo counterparts due to the presence of aberrant cells that emerge during tissue development in multicellular organisms but are effectively removed via proofreading mechanisms that often exploit apoptosis. The design and engineering of such processes are notably absent from current approaches for building PSC-derived multicellular systems.
Scientists in Ebrahimkhani's lab at the University of Pittsburgh address this gap by introducing a “subtractive multicellular engineering” approach, using genetic circuits that integrate logic-gated computing and synthetic apoptosis. Through this approach, they enhance tissue maturity in human PSC-derived liver organoids. They also demonstrate the versatility of this approach in a human post-implantation embryo model, where it improves pro-amniotic cavity development, a key morphogenetic feature. Their results establish a framework for building tissues in vitro via controlled elimination of aberrant cells during morphogenesis.
Read the article in Cell Stem Cell
WORTH (RE)SHARING
EPAA 3Rs Student Grants 2027: applications are open – deadline on November 13
Is the NAMs sector entering a new commercial phase? – by Dr Clive Roper
Where NAMs Beat Animal Models – by Dr Michael Phelan
A video to learn more about the NIH Standardized Organoid Modeling (SOM) Center
ICCVAM 2024-2025 biennial progress report: Key NICEATM and ICCVAM accomplishments and impact
A Report of the ICCVAM Per- and Polyfluoroalkyl Substances Workgroup
The revised Safe and Sustainable by Design (SSbD) Methodological Guidance has been published
AI-driven Digital Kidney model has been accepted into the ISTAND program
White paper: Bridging The Gap Between R&D and GMP – Concept Life Sciences
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
European Research & Innovation Days 2026 – November 10 & 11 2026, in Brussels (Belgium) and online
HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations – November 12 & 13 2026, online
ESMO: AI & Digital Oncology Congress 2026 – November 16–18 2026, Berlin (Germany)
