NAMs News
SEPT. 14-18, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. Building Europe’s capacity for NAMs: Contributions from the project STEP4NAMs
Across Europe, New Approach Methodologies (NAMs) are increasingly recognised as tools for more human- relevant, predictive and ethically responsible biomedical research. Yet uptake in (Bio)Pharma and MedTech development remains slower than scientific progress would suggest. This is not simply a technology problem.
Within STEP4NAMs, partners from six North-West European countries examined the conditions shaping NAM adoption. The analysis drew on publicly available information. It was complemented by 45 stakeholder interviews with NAM developers, users and organisations working with animal models. Feedback from the project’s Strategic Advisory Board, which brings together experts from across the NAM ecosystem, added another perspective. Together, these sources helped clarify why promising methods still struggle to move from research into wider use.
2. EMA/HMA platform discussed how to advance NAMs in regulatory science
The EMA/HMA European Platform for Regulatory Science Research dedicated part of its June 2026 meeting to NAMs and the integration of regulatory considerations into their development for use in medicines R&D. The meeting brought together researchers, regulators and other stakeholders to discuss how regulatory science can help bridge the gap between scientific innovation and regulatory application.
Presentations highlighted the importance of considering the intended regulatory use of NAMs from the outset, as well as the need to generate appropriate evidence to demonstrate their relevance, reliability and fitness for purpose. In his presentation entitled “What I think about when I talk about NAMs”, Peter van Meer (EMA NcWP, MEB) particularly discussed the evidence needed to support the regulatory acceptance of NAMs in medicines development, including the importance of defining a clear Context of Use.
Read more and access the presentations
3. Ncad report: From niche to norm — Transition Policy Advice 2026
On 9 September 2026, the NCad (Netherlands National Committee for the protection of animals used for scientific purposes) presented the policy advice report ‘From niche to norm – Transition Policy Advice: working together towards a society without animal experiments’ to the Ministry of Agriculture, Fisheries, Food Security and Nature. The NCad issued this policy advice on its own initiative, as a follow-up to the 2016 Transition Policy Advice and the 2024 evaluation report.
The policy advice sets out five pillars: governance and ownership, reassessment of the ethical framework, innovation and ecosystem policy, international strategy, and monitoring. For each pillar, the policy advice contains recommendations to the Minister and other responsible ministers on the conditions under which research, policy and practice can jointly contribute to the transition.
4. The UK’s first robotic infection lab is built around human organoids
Recently, the Liverpool School of Tropical Medicine (LSTM) opened the UK’s first high-containment robotic laboratory, the Liverpool Accelerate Laboratory. Dedicated to infectious disease research, the £20 million facility combines AI, robotics, machine learning and human organoids to accelerate the development of new drugs, vaccines and diagnostics.
Operating at Containment Level 3, the facility is part of the LSTM-led Infection Innovation Consortium. Its human organoid models are designed to replicate how human tissues respond to infection and potential treatments, while robotic systems enable the high-throughput screening of large numbers of candidate therapies, vaccines and diagnostics. By combining advanced human models with automation and AI, the laboratory aims to accelerate research while reducing reliance on conventional experimental approaches.
5. How online NAM platforms are changing toxicity testing
Regulatory landscapes on both sides of the Atlantic reflect the transition towards the uptake of NAMs. In the United States, the U.S. Environmental Protection Agency’s shift toward validated NAMs to reduce reliance on animal testing is supported by legislative changes, most notably the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act. Similarly, in Europe, regulators have broadened the acceptance of non-animal approaches. Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) implemented by the European Chemicals Agency (ECHA), data gaps may be addressed through a range of alternative methods when they are scientifically justified and transparently documented.
Together, these developments reflect a strong push toward integrating multiple lines of evidence rather than relying on a single testing approach. In a recent article Kinga Nimz, Karolina Jagiello and Maciej Stępnik from JHU Toxicology Policy Lab discuss the role of online NAM platforms in structuring and facilitating access to existing non-animal methods, using acute inhalation toxicity as a case study.
6. A decision tree for acute oral toxicity: Implementing the last resort requirement in practice
Acute oral toxicity (AOT) testing is widely used for hazard identification in chemical safety assessment, but traditional animal methods are still implemented despite their scientific limitations and ethical implications. Despite the availability of non-animal methods, regulatory uptake has been inconsistent, also due to a lack of structured guidance. To address this, the Animal-Free Safety Assessment Collaboration has developed a science-based Decision Tree (DT) aligned with the Organisation for Economic Co-operation and Development (OECD) Integrated Approaches to Testing and Assessment (IATA) framework.
The DT is built as a specific IATA to provide a transparent, modular workflow integrating in silico tools, in vitro assays, and weight of evidence (WoE) strategies to support AOT hazard identification for regulatory decision-making, such as REACH, ensuring that animal testing is used only as a last resort.
7. How legal liability concern is slowing the future of NAMs
By contrast with animal models, NAMs lack a unified and transferable validation framework, with different regulatory bodies applying different approaches. This creates a “legal uncertainty” that can discourage institutions, regulators and sponsors from moving away from established animal-based practices.
The article written by Mackensey Alexander, and published on the JHU Toxicology Policy Lab website, calls for a robust validation and regulatory acceptance framework that could provide NAMs with greater legal certainty and establish a recognised standard of care across jurisdictions. “It is not a lack of innovation that creates caution in the industry around NAMs, but rather a question mark surrounding the legal consequences of their integration. (…) Until institutions, regulators, and sponsors can identify a clear, transferable validation framework that courts recognize as establishing a reliable standard of care, legal uncertainty will continue to suppress the development and adoption of NAMs”.
INTERVIEWS, NOMINATIONS & AWARDS
8. 3DCC Platform Conversations: Maurice Whelan on building a future for biomedical research beyond animal testing
What will it take to move from traditional animal-based approaches toward more human-relevant methods in biomedical research, drug development and safety assessment?
In episode 7, 3DCC Platform Conversations sit down with Dr. Maurice Whelan, Head of the Laboratory for Alternatives to Animal Testing at the European Commission’s Joint Research Centre (JRC). Dr. Whelan shares why regulation works from the perspective of the European commission, how the EU, JRC, and OECD are advancing NAMs, and why platforms like BSW (Biologics Workshop) x 3DCC are essential for connecting scientists, regulators, and industry to shape the future of animal-free science.
TOOLS, PLATFORMS, CALLS
9. NIH call for applications: Advancing HIV research through existing human data and biospecimens
The U.S. National Institutes of Health (NIH) is inviting applications that use existing HIV/AIDS datasets and archived human biospecimen collections to address key questions in maternal, pediatric and adolescent HIV research. The initiative encourages the use of human-based approaches, including AI, data science and statistical modelling, to investigate HIV, treatment effects and long-term health outcomes.
Reusing existing human data and patient biospecimens can help validate previous findings, address new research questions and maximise the value of existing research resources, while reducing the time and resources required to generate new evidence. Participating institutes: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Institute of Mental Health (NIMH).
Application deadline: 21 October 2026
10. Frontiers in Pharmacology Research Topic: Organoids and NAMs in Drug Discovery – From Target to Industry
Drug discovery is undergoing a generational shift. The FDA Modernization Act 2.0, the EPA’s NAM roadmap, and EMA’s evolving guidance are accelerating industry adoption of non-animal models.
A new research topic in the journal Frontiers in Pharmacology convenes leaders from academia, the pharmaceutical industry, and regulatory agencies to benchmark where the field stands in 2026, where it is going, and what translational and regulatory gaps remain as we enter this new era. While the papers can draw on specific indications or model systems, the themes of what challenges remain for full adoption into the drug discovery and regulatory workflow should be approached agnostically.
Manuscript submission deadline: 15 May 2027
INDUSTRY, BIOTECH & PARTNERSHIPS
11. FACTS-3D: HeartBeat.bio and Cubase Bio partner to advance human cardiac organoid-based drug discovery
HeartBeat.bio and Cubase Bio have announced a strategic research collaboration to develop high-throughput 3D spatial transcriptomics for human cardiac organoids.
Supported by approximately €1 million in Eurostars funding, the FACTS-3D project aims to improve the characterization of myocardial fibrosis and heart failure for cardiovascular drug discovery. The collaboration combines HeartBeat.bio’s human cardiac organoid platform with Cubase Bio’s 3D spatial transcriptomics technology, illustrating the growing integration of advanced human models and high-content molecular profiling in drug development.
12. Daxiang Biotech joins Scientist.com: Expanding global access to its organoid-on-chip services
Daxiang Biotech has joined Scientist.com as a Registered Supplier, creating a new way for pharmaceutical, biotech, and research organizations worldwide to access its organoid, organoid-on-chip, and microphysiological system (MPS) technologies and research services. The move expands Daxiang’s global reach and gives researchers another channel to discover its capabilities, connect with the team, and explore potential research collaborations.
13. Conscio Group and CellMade Laboratories: Strategic partnership to advance human-relevant pyrogen testing
Conscio Group and CellMade Laboratories, an independent French laboratory specializing in human-cell-based pyrogen testing, are pleased to announce a strategic partnership. This collaboration provides European biotech and biopharmaceutical companies with direct access to human Peripheral Blood Mononuclear Cell-based Monocyte Activation Testing (MAT) and comprehensive pyrogen safety solutions.
The partnership directly addresses critical safety and regulatory shifts in the pharmaceutical industry and aligns with global regulatory evolutions, including the European Pharmacopoeia Chapter 5.1.13 and US FDA guidelines, which advocate for risk-based, human-relevant testing strategies.
SCIENTIFIC DISCOVERIES & PROTOCOLS
14. 3D human iPSC-derived cardiac organoids for antifibrotic drug screening
Cardiac fibrosis is a pathological feature of heart failure that exacerbates myocardial dysfunction. However, current therapies remain limited, largely due to the lack of translatable drug discovery platforms. To address this, researchers developed a platform based on human induced pluripotent stem cell – derived cardiac organoids (iPSC-COs) to screen antifibrotic compounds.
To validate the iPSC-CO platform, they conducted a pilot screen of several FDA – approved cardiovascular drugs, including LCZ696 (sacubitril/valsartan), valsartan, metoprolol, torsemide, furosemide, and aspirin. They also tested sorafenib, an anticancer agent with reported antifibrotic effects, as well as dihydroartemisinin.
WORTH (RE)SHARING
3RCC’s recommendations for strengthening and enhancing Switzerland’s cell technology platforms
“New laboratory system develops 3D miniature models of human muscle tissue”, Bionity
“Development of a Placenta-Based Microsurgical Training Model for Vestibular Schwannoma Resection”, Galeazzi et al., World Neurosurgery
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Webinar series: Organoid Meet-up: Methods in Organoid Development – 21 Sept. 2026 – 03:00pm (BST), online
hDMT Industry meets Academia event – 24 Sept. 2026, Utrecht (The Netherlands)
Predictive Human Biology Symposium – 30 Sept. 2026, Karolinska Institutet, Stockholm (Sweden)
NAMs and NGRAs for the predictive assessment of systemic toxicity, Adebiotech Symposium – 1 & 2 Oct. 2026, Paris Saclay (France)
