NAMs News
JUNE 01 - 05, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. European Commission accelerates transition away from animal testing in chemical safety assessments
Monday 1st of June, the European Commission presented its roadmap towards phasing out animal testing for chemical safety assessments, setting out a structured transition to innovative non-animal approaches across 15 legislative areas. The roadmap includes 22 actions organised around three pillars:
- Accelerating the development, validation and regulatory uptake of non-animal methods
- Supporting research, innovation, AI and data-driven approaches to safety assessment
- Strengthening collaboration between EU institutions, member countries, industry, academia and international partners
“The publication of this roadmap marks a pivotal step towards modernising chemical safety assessments while reinforcing Europe’s leadership in innovation. By phasing out animal testing, we are not only upholding higher ethical standards but also strengthening our competitiveness through cutting-edge, non-animal alternative technologies.” Stéphane Séjourné, Executive Vice-President for Prosperity and Industrial Strategy.
Read more and download the Roadmap
2. Navigating the EMA qualification of novel methodologies for digital endpoints: lessons from the DEEP project proof of concept
As digital measures continue to transform drug development, clinical practice, and patient experience, there is an increasing need for standardization in the development, validation, qualification, and regulatory acceptance of these measures.
A multi-stakeholder project, led by the Digital Evidence Ecosystem & Protocols (DEEP), in collaboration with EFPIA (European Federation of Pharmaceutical Industries and Associations) and the EMA (European Medicines Agency) was initiated to explore whether the DEEP platform could foster and facilitate regulatory qualification of digital measures in several ways: e.g.: pre-competitive collaboration for evidence generation, structured presentation of evidence to support qualification requests and explore utility with a view to lifecycle management of qualified measures, as well as the utility of the DEEP platform to potentially facilitate aspects of the EMA Qualification of Novel Methodologies. A new article published in Nature presents the methodology used to conduct the proof of concept in a structured approach.
3. From fragmentation to standardization: SMART OOC moves the field forward
A recent case published by the Dutch Research Council (NWO) highlights how the SMART Organ‑on‑Chip (OOC) Perspectief program, emerging from the hDMT community, addresses the challenges of a broader industrial and regulatory adoption by strengthening the building blocks that enable diverse OOC models to translate and scale.
As program leader Prof. Jaap den Toonder, TU Eindhoven, explains: “(…) Each chip has its own dimensions, and connections for fluid inlets, sensors or pumps are located in different places. As a result, they often do not fit standard production and testing systems used in industry.” Rather than replacing ongoing innovation in organ‑specific models, SMART OOC focuses on platform‑level alignment: standardized chip formats, modular components and interfaces designed to integrate with existing workflows. End‑users from pharma, biotech and technology development have been involved from the outset to ensure relevance and applicability.
Read the case study on NWO website
4. BimmoH: Leveraging AI tools to collect and structure information on human biology-based models used in biomedical research
The Biomedical models Hub (BimmoH) is the world’s largest dataset containing scientific article references making use of human biology-based models powered by Artificial Intelligence (AI). A new report provides the technical details of the work performed to create the BimmoH dataset, allowing full transparency on the article selection process.
The result is a comprehensive, curated collection of hundreds of thousands of resources that can significantly reduce research time and accelerate innovation, and that will be kept updated over time. Beyond academia, BimmoH offers value to regulators, policymakers, funders, and industry stakeholders. It can inform evidence-based decisions across areas such as drug development, safety assessment, and early-stage biomedical exploration.
5. Significant milestone for Japan in regenerative medicine
Japan has taken a major step toward the clinical adoption of regenerative medicine by approving public health insurance coverage for Amchepry, an iPS cell-derived therapy developed by Sumitomo Pharma for Parkinson’s disease. The treatment, which uses dopamine neuron precursor cells generated from induced pluripotent stem cells (iPSCs), is the first commercially available iPSC-based medical product to receive insurance reimbursement worldwide.
Beyond its significance for Parkinson’s disease, this decision highlights Japan’s long-term strategy to accelerate the translation of iPSC technologies from research to clinical practice.The milestone reflects the growing maturity of human cell-based technologies, which are increasingly shaping both regenerative medicine and next-generation biomedical research ecosystems. Future post-marketing studies will now be critical to confirm long-term efficacy, safety, and cost-effectiveness in real-world settings.
6. Australia’s New Approach Methodologies Advantage
Australia has quietly become a powerful launchpad for early-phase clinical development, and a rising hub for New Approach Methodologies (NAMs). However, for many US and EU biotech and drug development innovators, this opportunity remains largely undiscovered.
A recent whitepaper argues that Australia’s unique regulatory architecture, centered on the Clinical Trial Notification (CTN) pathway, the Therapeutic Goods Administration (TGA), and an internationally progressive Human Research Ethics Committee (HREC) system, delivers a measurable competitive advantage for drug developers seeking to move faster and cheaper from preclinical to first-in-human. When combined with Australia’s emerging NAMs ecosystem, government-backed infrastructure, and a 43.5% R&D tax rebate, that proposition is quite compelling.
INTERVIEWS, NOMINATIONS & AWARDS
7. ALTEX Prize awarded Uwe Marx, founder of TissUse GmbH
The ALTEX Prize, awarded at the MPS 2026 World Summit Closing Ceremony, recognises the best original article published in ALTEX and sustained work that has helped move forward the field of NAM. This year, the prize went to TissUse GmbH’s founder Uwe Marx for the t4 Workshop Report: “Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare”.
The t4 workshops have become one of the key reference points in the MPS field – bringing together leading voices from academia, industry, MPS providers and users, and regulatory authorities from around the world to shape the future of MPS and NAMs. This work, driven and organized by Uwe, has helped establish a truly global platform for exchange and alignment across the field.
Read the announcement by TissUse GmbH
TOOLS, PLATFORMS, CALLS
8. Share your perspective on human stem cell models
How well do human stem cell-based models match what industry needs today? And how can shared research facilities help to drive the field forward? These questions are at the heart of a new research initiative within the hDMT INFRA project, a large-scale Dutch infrastructure dedicated to the development and implementation of human-based organ and disease models.
The project aims to better understand industry expectations and identify opportunities to strengthen collaboration between NAM developers, academic researchers, and end users. Newest team member Loris Van Brackel, student at Leiden University Medical Center, has joined the hDMT INFRA project to research this.
To see more calls: Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
9. Curi Bio Launches the Curiverse™: The industry’s first closed-loop ecosystem
Curi Bio, a global leader in functional human biology, unveiled the Curiverse™ at the MPS 2026 World Summit, the industry’s first closed-loop ecosystem unifying assay-ready iPSC-derived cells, automated high-throughput systems, and cloud-based data analytics for industrial-scale 3D human drug discovery.
As regulators worldwide accelerate the shift to Non-Animal Models in the wake of the FDA Modernization Act 2.0 & 3.0, Curi Bio is breaking the scalability bottleneck that has kept complex 3D tissue models confined to boutique benchtop workflows. The Curiverse delivers the integrated infrastructure pharma and biotech teams need to operationalize NAMs at industrial-scale. “The bottleneck in drug discovery isn’t just the biology — it’s the integration of Cells, Systems, and Data. With the Curiverse, we’re moving human-relevant discovery to industrial scale.” — Dr. Nicholas Geisse, CEO, Curi Bio.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. Human inflammatory bowel disease-on-a-chip for modelling disease progression, cancer initiation and sex-specific effects
Patients affected by inflammatory bowel disease (IBD) exhibit compromised intestinal barrier function and decreased mucus accumulation, as well as increased inflammation, fibrosis and cancer risk, with symptoms often being exacerbated in women during pregnancy.
In a new study, a multi-disciplinary research team led Prof. Donald Ingber, Wyss Institute, with clinicians at McGill University in Canada and Massachusetts General Hospital, replicate these IBD hallmarks in human-derived organ-on-a-chip devices lined by colon epithelial cells from individuals with IBD when interfaced with matched fibroblasts, cultured under flow, exposed to peristalsis-like motions and perfused with circulating immune cells. The data suggest that the intestinal stroma, sex hormones and peristalsis-associated mechanical deformations have a key role in driving inflammation, fibrosis and disease progression in male and female individuals with IBD.
Read more in Nature Biomedical Engineering
11. Assembloids: The next dimension in organoid research
Assembloids are self-organizing three-dimensional structures formed by integrating distinct organoids or incorporating specialized cell types into organoids, providing enhanced cellular diversity, structural complexity, and physiological relevance. A recent review summarizes recent strategies for incorporating vascular, neural, and immune components into organoids and for assembling multiple organoid types.
Key factors of assembloid formation, such as cell source, intercellular interactions, cytokine signaling, and extracellular matrix properties, are discussed. Advances in bioengineering have enhanced the scalability and precision of assembloid generation. By combining biological and technical perspectives, this review offers guidance for the efficient assembloid construction and highlights their application in disease modeling, drug screening, and future clinical translation.
Read more in Cell Biomaterials
12. Biofabricated skin grafts are in our future, but what will they be built with?
A concise analysis by James McCullough, from Humabiologics, a company specializing in human-derived biomaterials for biomedical research and regenerative medicine, highlighted emerging strategies to eliminate animal-derived components from engineered human skin models. Drawing on three recent studies, the analysis compared fully synthetic scaffolds, human-derived extracellular matrix-based approaches, and entirely iPSC-derived skin constructs, all developed as xeno-free alternatives to conventional models relying on animal-derived materials such as collagen or Matrigel.
Together, these studies illustrate a broader trend across tissue engineering and advanced in vitro models: the search for human-relevant, clinically translatable platforms built without animal-derived components. Whether based on synthetic biomaterials, human-derived extracellular matrices, or iPSC-derived cells, these next-generation skin models could help improve reproducibility and translational relevance while supporting the development of more ethical research and regenerative medicine applications.
WORTH (RE)SHARING
ECHA Science seminar: Virtual Control Groups in pre-clinical toxicity studies, online
Seven major NAMs announcements: The entire global regulatory architecture has converged on context of use as the governing framework. Analysis by Stefano Gaburro
Animal-testing alternatives will require a cultural change in research institutions, published in Nature
20-ish Questions with Donald E. Ingber
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Workshop “From Cell to Clinic: Multi-scale Mechanistic Modeling and Statistical Learning for Oncology”– 8 – 10 June 2026, CRCL, Lyon (France)
2026 Summer Immersion on Innovative Approaches in Science – 15 – 18 June 2026, Johns Hopkins Bloomberg School of Public Health, Baltimore (USA)
ICCS 2026 Symposium, Advancing Animal-Free Science Through Innovation & Engagement – 15 June 2026, Brussels (Belgium)
