NAMs News
Oct. 12 - 16, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. NAMs in pharmaceutical development: Survey insights on adoption, infrastructure, and the path to broader implementation
New Approach Methodologies (NAMs) have long contributed to pharmaceutical development with growing attention now focused on their use at regulatory decision points to reduce reliance on laboratory animal models in drug safety and efficacy assessment. Yet validated NAMs remain limited to specific endpoints, and uncertainty persists regarding human translatability and health authority acceptance. In the absence of globally harmonized frameworks, validated-method databases, and clearly defined contexts of use, companies vary in how they identify, evaluate, govern, and implement NAMs.
A new article summarizes findings from a survey conducted by the Innovation & Quality International Consortium (IQ) 3Rs Implementation of Replacement Working Group on industry practices for NAM identification and implementation. Forty-five companies, primarily large and mid-sized organizations headquartered across Asia, the United States, and Europe, provided insights into governance, accountability, evaluation strategies, integration across drug development, and barriers and opportunities.
Read more in Regulatory Toxicology and Pharmacology
2. What is ICCVAM for, anymore? Rethinking coordination of NAM validation in the United States
A new analysis from the Johns Hopkins Toxicology Policy Lab examines the evolving role of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) as US federal agencies increasingly develop their own programmes for NAMs. While ICCVAM’s 2024 framework promotes flexible, fit-for-purpose approaches to validation and regulatory acceptance, the article argues that its influence as a central coordinating body has weakened as implementation becomes more agency-specific.
The author calls for ICCVAM to play a stronger cross-agency coordination role, helping to reduce duplication, harmonise validation practices and provide a more consistent basis for regulatory acceptance. The analysis highlights a broader policy challenge for NAMs: scientific progress and guidance alone may not ensure lasting implementation without clear institutional responsibilities and mechanisms for sustained coordination.
3. Australia’s TGA outlines regulatory expectations for NAMs
Australia’s Therapeutic Goods Administration (TGA) has published new guidance explaining how NAMs can support the development and regulatory assessment of medicines and other therapeutic goods. The regulator already considers non-animal data in pre- and post-market assessments, including in silico methods for genotoxicity and impurity safety assessments. It supports the use of NAMs when scientifically justified and appropriate for their intended purpose, while acknowledging that many methods cannot yet replace animal studies on a one-to-one basis.
The guidance outlines four key considerations for regulatory acceptance: a clearly defined context of use, relevance to human biology, technical reliability and reproducibility, and fitness for purpose. Through international regulatory collaboration, the TGA aims to support greater harmonisation and wider adoption of these methods.
4. Tech to replace animal testing is almost ready – Scientists are not
Seventeen years ago, cell biologist Donald Ingber and his colleagues at Harvard University’s Wyss Institute for Biologically Inspired Engineering submitted a paper to the journal Science describing their model human lung. A recent story told by Ilka Maschmeyer, a translational toxicology researcher and executive at the German biotech company TissUse, shows how much things have changed.
However, wider adoption remains constrained by challenges beyond the technology itself. “This transition process is much more complicated than you would think,” says Thomas Hartung, director of the Center for Alternatives to Animal Testing at Johns Hopkins University. “It is more about change management than it is about the technology.”
5. Advancing NAMs together: Validation, data sharing and regulatory alignment remain key challenges
A new report from AAPS (American Association of Pharmaceutical Scientists) and BioIVT synthesizes discussions held on 10 September 2026 with scientists from industry, contract research organizations (CROs), regulatory professionals and academia on the transition towards routine use of NAMs.
The discussions identified several barriers to broader adoption, including uncertainty over validation requirements, unclear responsibility for generating supporting evidence, inconsistent protocols and limited access to shared datasets linking NAM results with preclinical and clinical outcomes. Participants called for context-of-use-specific qualification frameworks, cross-company data-sharing initiatives and greater international regulatory harmonization. The report highlights a central challenge for the field: translating promising technologies into reproducible, trusted methods that can independently support scientific and regulatory decisions.
INTERVIEWS, NOMINATIONS & AWARDS
6. How NIH’s Nicole Kleinstreuer is working to reduce animal testing while avoiding a ‘backlash’
In the past 18 months, the National Institutes of Health (NIH) has been working overtime to push new policies to reduce animal testing, with one woman at the helm: Nicole Kleinstreuer, Ph.D. In her role as NIH deputy director for program coordination, planning and strategic initiatives, Kleinstreuer oversees research and strategic programs ranging from women’s health and disease prevention to data science and dietary supplements.
Kleinstreuer’s role sits within the office of NIH Director Jay Bhattacharya, M.D., Ph.D. One of Bhattacharya’s “top priorities” is advancing human-based science with the most modern and innovative approaches, Kleinstreuer explained to Fierce in an interview.
7. Twenty years after the discovery of iPSC technology: How has it changed science and where could it take us next?
Announced by the International Society for Stem Cell Research (ISSCR), a new Stem Cell Reports Voices piece marks the 20th anniversary of iPSCs with researchers from around the world that reflect on how this transformative technology has reshaped regenerative medicine, disease modeling, drug discovery, developmental biology, and cell engineering.
Among these international researchers: Sonja Schrepfer, Cedars-Sinai; Hongmei Wang, Chinese Academy of Science; Laurent David, Université de Nantes; Hans Clevers, Hubrecht Institute, Utrecht University, and more.
TOOLS, PLATFORMS, CALLS
8. CHIASMA workshop: Harmonisation and standardisation of test methods – The challenges of NAMs and advanced materials
The development of NAMs and their successful uptake and acceptance by regulatory agencies is a global challenge that will require the participation of many different stakeholders. It will require policymakers around the world to accept these test results and for NAMs developers to ensure that their methods are robust and can be harmonised and accepted for regulatory testing. Due to their unique properties, nano and advanced materials require the updating of test methods to produce the data required by regulators.
This online workshop will take place on November 24 and 25, 2027 and is brought by the Horizon Europe projects CHIASMA, DESIDERATA, iCare, NAMWISE, nanoPASS and RADAR, along with the Malta Initiative.
9. Suppo3Rt desk for access to expertise on NAMs
NAMs are evolving rapidly, and the expertise required to apply them is becoming increasingly specialized. If you are exploring animal-free alternatives but are not sure where to start, or who to contact, 3Rs Centre Utrecht (3RCU) has set a support desk Suppo3Rt connects you directly with the relevant expert(s).
The service is free of charge, confidential, and tailored to your specific research question. Suppo3Rt was established to bridge a gap identified in a 3RCU exploratory study, which highlighted a demand for additional NAMs expertise and a need for guidance and interpretation of information on NAMs.
INDUSTRY, BIOTECH & PARTNERSHIPS
10. International, cross-sector collaboration commits $1.8 billion to build foundational data for AI models to predict and treat disease
Biohub, the U.S. Department of Energy (DOE), the NIH, and new funding partners are investing $1.8 billion in funding, data, computation, and new measurement technology, the largest coordinated commitment to generating AI-ready biological data to date. The result will be an open resource for the research community that provides the foundation for greater understanding and ultimately treatment of human diseases.
- DOE will invest more than $500 million over five years in lab measurement, modeling and computation toward the international effort to build an AI-ready open data resource.
- NIH will coordinate the contribution of relevant datasets, repositories, and knowledge bases developed through more than $500 million in prior federal investment aligned to this initiative.
- Biohub will work with NIH to standardize these datasets for AI model training.
In addition, Google DeepMind, Isomorphic Labs, and Meta are collectively investing $300 million in the Virtual Biology Initiative to create the technologies and multi-modal datasets needed to build predictive models of life.
SCIENTIFIC DISCOVERIES & PROTOCOLS
11. Engineering human multi-organ tissue-chip niches for drug ADME and toxicity prediction
Predicting human drug responses in vitro remains a central challenge in drug development. Animal models have shown limited accuracy in recapitulating human drug absorption, distribution, metabolism, excretion (ADME) and toxicity, which arise from coordinated activities across multiple organs. Multi-organ-on-a-chip systems (mOoCs) are a class of promising NAMs that can reconstruct these inter-organ processes. Existing mOoCs have demonstrated proof of concept for inter-organ coupling but translation-ready systems remain out of reach.
A recent review led by Joseph C. Wu addresses two key challenges: how to preserve the distinct biochemical and biomechanical niches of each organ while enabling controlled exchange between them, and how to develop mOoCs into robust translation-ready systems.
Read the article in Nature Biomedical Engineering
12. New protocols advance intestinal organoid research and human-relevant models
A new edition of Intestinal Stem Cells: Methods and Protocols, published in the Methods in Molecular Biology series, brings together practical protocols covering intestinal stem cell biology, organoid culture, single-cell analysis and disease modelling.
Several chapters of this second volume are particularly relevant to the development of NAMs, including animal-free intestinal epithelial organoid-sheet cultures, human small-intestinal organoids differentiated into mature epithelial cell types, and in silico modelling of intestinal stem cell dynamics.
Explore the book and its chapter list
13. A practical decision-making approach for tiered in silico chemical hazard assessment based on the SSbD framework
The “Safe and Sustainable by Design” (SSbD) approach promotes the development of chemicals that are inherently safer and more sustainable, including viable alternatives to hazardous substances. In silico methods using computational tools and simulations support the SSbD approach by predicting the toxicity, environmental persistence and performance of potential substitutes prior to upscaling in physical testing.
Surfactants (SFs) and flame retardants (FRs) are among the many areas of interest to regulators and scientists across various industries. Due to the massive growth of global markets resulting from a wide range of their applications, and evidence of the adverse impact on the environment and human health, there is a pressing need to accelerate the design and implementation of safer alternatives for those chemicals. In a paper co-written by QSAR Lab, researchers present an intuitive and harmonised workflow on how the use of quantitative structure – activity relationship (QSAR) −based in silico tools for preliminary hazard assessment and data gap filling, in accordance with the SSbD multi-tiered approach.
Read more in Environment International
WORTH (RE)SHARING
Vote on ENVI opinion on the Biotech Act I Regulation
EFSA needs for scientific excellence and regulatory readiness
China’s PIONEER Program for NAMs: What It Means for Chinese (and Global) Biotech, Michael Phelan
Who goes first in NAM adoption, Lukas Gaats, Mo:re Science
hiPSC-derived O&OOC systems: New frontiers in neural tube defect research, Wang et al., Stem Cell Reviews and Reports
Researchers develop groundbreaking method for printing blood capillary networks
AI scientist autonomously generates and validates new biological discoveries, Bionity
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Panel discussion “From innovation to first-in-human trials: Practical guidance for using NAMs in Australia” – 21 October 2026, 4:30 pm – 5:15 pm – Gold Coast (Australia)
Workshop “Alternative Methodologies in Pharmaceutical Development” – 20 October 2026, 10:00 am‑5:00 pm, & 21 October 2026, 10:00 am-12:00 noon – NIH Neuroscience Center Building, Rockville (US)
DAIBR Workshop: “Recent Developments in Human-Based Models” – 22 October 2026, 8:30 am‑6:00 pm, & 23 October 2026, 8:30 am-12:30 pm – NIH Neuroscience Center Building, Rockville (US)
Live Talks “Asian NAMs’ Landscape: Scientific and Regulatory Perspectives” – 22 October 2026, 12:30 pm (GMT+2), online
International Conference on Organoid Intelligence 2026 – 26 – 27 October 2026
The Bloomberg Center, Washington (US)
