NAMs News
SEPT. 28 - OCT. 02, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. China: OOC and AI technologies gain momentum from national strategy to industrial translation
China is increasingly translating its national ambitions for organoids and organ-on-chip (O&OOC) technologies into research, investment and industrial infrastructure. As previously reported in Pro Anima’s NAMs News “Advancing NAMs in China” (31 August – 4 September 2026), the country’s 15th Five-Year Plan identifies O&OOC among the emerging technologies to be advanced during 2026 – 2030. The Pharmaceutical Industry Development Plan for the same period, issued on September 18 by the Ministry of Industry and Information Technology and nine other authorities, further now specifically calls for breakthroughs in O&OOC, and identifies AI-driven organoid/organ-on-chip drug evaluation as a technology to be advanced towards translation.
Recent developments in Nanjing (capital of Jiangsu Province, in eastern China) illustrate how this policy direction is being translated into an expanding research and industrial ecosystem:
- The city hosted the 2026 Asia-Pacific Summit of the International MPS Society and the 9th Academic Conference on Organoids and Organ-on-Chip Technologies on September 21 – 24, bringing together researchers, companies and regulatory stakeholders to discuss MPS applications, regulatory science, standardization, scalability and AI. In a recent post back from the Summit, InSphero CEO Jan Lichtenberg emphasized the dynamic among China players: “China is moving fast on MPS, but what impressed me most in Nanjing was not the technology. It was the focus on implementation.”
- During the summit, Southeast University (SEU) unveiled a 2,300 m² OOC technology-transfer platform integrating R&D, public technical services, industry – academia – clinical translation and industrial incubation, with applications including drug development, precision medicine and cosmetics and chemical safety assessment.
- At the same time, Jiangsu Aiweide Biotechnology completed a new financing round, with funding directed towards standardized multi-OOC models, intelligent equipment and AI image-analysis systems.
Read more on the Pharmaceutical Industry Development Plan
2. SPADE platform: Singapore launches new human data platform to advance precision diagnostics and treatment
The SingHealth Duke-NUS Academic Medical Centre has launched SPADE (Spatial Profiling and Disease Exploration), a cross-institutional research platform combining clinical and pathology expertise with biomedical, computational and data-science capabilities. Supported by a S$6 million grant, the initiative aims to investigate how diseases develop and why patients respond differently to treatments, with the longer-term goal of translating these insights into more precise diagnostics and therapies.
SPADE is led by the National Cancer Centre Singapore and co-led by Singapore General Hospital and Duke-NUS Medical School. Its first industry collaboration involves 10x Genomics, with a focus on strengthening spatial biology capabilities.
3. ISO advances standardization of OOC data for digital twins and computational modelling
ISO is developing ISO/CD 25591, “Microphysiological systems and Organ-on-Chip — Digital twins and computational modelling,” which aims to establish a standardized framework for the data and metadata generated by organ-on-chip (OOC) and microphysiological systems (MPS).
The draft addresses experimental design, data outputs, device- and assay-level metadata, and links to computational models, including data provenance and versioning. It is intended to support FAIR (Findable, Accessible, Interoperable, Reusable) and regulatory-ready data as these technologies are integrated with digital twins and computational modelling. The project also addresses reproducibility, with recommendations and requirements for experimental design and reporting. Following its Committee Draft consultation, which closed on September 4, 2026, ISO/CD 25591 was referred back to the working group and has been approved for registration as a Draft International Standard (DIS). The project remains under development, and no date has yet been announced for DIS registration.
INTERVIEWS, NOMINATIONS & AWARDS
4. Pro Anima interview: Dr. Guan-Yu Chen on AI, human biology and the future of biomedical research
Artificial intelligence (AI) is significantly transforming drug discovery. However, its true value depends on the quality of the biological data fueling it. For Dr. Guan-Yu Chen, founder and CEO of Anivance AI, the future of biomedical research lies in the convergence of AI, organs-on-chips, automation, and human biology.
In a new interview for Sciences, Enjeux, Santé, Dr. Chen discusses how these technologies can be integrated into a coherent infrastructure for human-relevant research, and the challenges that remain to make such approaches more reproducible, scalable, and useful for decision-making. The interview explores the potential of combining AI with advanced human models to generate higher-quality evidence for drug development and toxicological assessment for humans.
5. UCLA receives $4.9 million from CIRM grants to advance human stem cell models for vision loss and infertility
Scientists at UCLA’s Broad Stem Cell Research Center have received $4.9 million in grants from the California Institute for Regenerative Medicine (CIRM) to advance stem cell-based approaches for vision loss and infertility.
- A $2.5 million award to Dr. Aya Barzelay-Wollman will support research into why transplanted retinal cells survive or fail to integrate in the damaged retina of patients with geographic atrophy, an advanced form of dry age-related macular degeneration. The team will combine human donor tissue, stem cell-derived retinal cells and advanced molecular analyses to map the cellular and molecular environments that influence cell survival and integration.
- A separate $2.4 million award, involving UCLA’s Dr. Amander Clark and led by Dr. Magdalena Zernicka-Goetz at Caltech, will investigate the earliest stages of human germ cell development. Using two complementary stem cell-derived models of early human development, researchers will map where and when primordial germ cells emerge, identify the surrounding tissues that guide them, and determine the molecular signals involved in their development, with the potential to provide new insights into mechanisms underlying infertility and support future approaches to diagnosis and treatment.
TOOLS, PLATFORMS, CALLS
INDUSTRY, BIOTECH & PARTNERSHIPS
6. Curi Bio’s 3D neuromuscular junction assay enters FDA’s ISTAND Program
The U.S. Food and Drug Administration (FDA) has accepted Curi Bio’s Letter of Intent (LOI) into its ISTAND Program, marking an important regulatory step toward qualifying the company’s human iPSC-derived 3D neuromuscular junction (NMJ) assay as a non-animal alternative to the mouse lethality bioassay currently used for botulinum toxin (BoNT) potency testing. The acceptance allows Curi Bio to move forward to the Qualification Plan phase with FDA’s Center for Drug Evaluation and Research (CDER).
Curi Bio’s acceptance is part of a broader expansion of the FDA’s ISTAND portfolio. Building on an earlier count by consultant Michael Phelan, Elliot Fisher, Co-Founder & CBO at Curi Bio, reviewed the FDA’s DDT database in September 2026 and identified 37 publicly disclosed ISTAND projects with 33 having received an LOI decision (26 accepted, 7 not accepted, and 4 pending). Of the accepted LOIs, 20 concern non-animal models. The analysis also reports a median time from submission to LOI acceptance of 146 days for submissions made since 2025.
7. SystImmune receives FDA clearance for an IND using NAMs
SystImmune Inc., a clinical-stage biotechnology company advancing next-generation multi-specific antibodies and antibody-drug conjugates (ADCs), announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms. The FDA clearance marks SystImmune’s first IND application utilizing NAMs as part of its integrated nonclinical safety and translational assessment package.
“We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies,” said Dr. Jahan Khalili, Senior Vice President of Research at SystImmune. “Human-relevant models gave us a more direct read on a molecule designed to engage multiple human pathways in the nonclinical package, built around NAMs.
8. Turbine and Daiichi Sankyo expand ADC discovery collaboration
Turbine, a virtual biology company, announced the expansion of its collaboration with Daiichi Sankyo following the successful completion of an initial feasibility program evaluating Turbine’s predictive modeling capabilities for Antibody-drug conjugate (ADC) development.
The parties will use Turbine’s virtual biology platform vLab™ to run Virtual Assays (computational experiments that simulate biological responses across large numbers of conditions) to accelerate and de-risk Daiichi Sankyo’s ADC discovery programs. The collaboration also establishes a foundation for iterative learning, where simulated experiments guide efficient data generation, and experimental validation feeds back into ever-improving computational models. Every lab-in-the-loop cycle sharpens Virtual Assays further, creating a compounding learning effect as new experimental data strengthens the knowledge base informing subsequent predictions and decisions across ADC discovery.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Predicting neoadjuvant breast cancer therapy response using BRIDGE from tumor transcriptomics and histopathology
While expression-based signatures inform adjuvant therapy in breast cancer (BC), no approved molecular biomarkers exist for the neoadjuvant setting, where early response prediction could inform treatment decisions. This challenge is compounded by intratumoral heterogeneity, as multiple malignant subtypes may coexist within a tumor and influence therapy sensitivity.
An NCI (National Cancer Institute)-supported research team has developed an AI tool called BRIDGE (BReast Intra-tumoral Deconvolution of Gene Expression) that analyzes patterns of gene activity within a breast tumor to predict a complete response to treatment before surgery. BRIDGE was trained on 10 transcriptomics datasets and tested on 24 independent ones spanning different subtypes. Six additional datasets with pretreatment hematoxylin and eosin slides and response data were analyzed to evaluate histology-based predictions.
Read more in Annals on Oncology
10. AI-based analysis offers new roadmap for precision oncology
How and why a tumor metastasizes — when a seemingly similar tumor doesn’t — remains one of the biggest questions in cancer research. Metastatic melanoma presents clinical challenges due to tumor heterogeneity and treatment resistance.
New research from György Marko-Varga’s lab at Lund University with Istvan Nemeth at the Szeged Clinical hospital, and Peter Horvath’s team at HUN-REN Biological Research Centre reports an integrative workflow combining AI-based digital pathology with spatial proteomics to support personalized treatment strategies in a case of a young patient with recurrent melanoma and multiple metastases. Their combined analysis provided a deep characterization of the tumor’s biology that helps explain its clinical behavior. Furthermore, their findings suggest that targeted therapies may provide limited benefit, while the combination with metabolic inhibitors could represent a more effective treatment option for the patient.
Read the article in Precision Oncology
11. Patient-derived organoid platform advances research on pediatric brain cancer
Researchers have developed a patient-derived brainstem glioma organoid (BSGO) platform that reproduces key features of H3K27M-mutant diffuse midline gliomas, an aggressive and difficult-to-treat pediatric brain tumor. Using multi-omics and functional analyses, the researchers identified dysregulated ACTIVIN signaling as a mechanism maintaining oligodendrocyte precursor cell-like stemness in these tumors. The organoid platform was subsequently used for intrathecal drug screening, enabling the identification of a three-drug combination as a potential therapeutic strategy.
Importantly, the study also explores the translational potential of organoid-guided personalized therapy. In patients with diffuse midline glioma, treatment informed by their tumor-derived organoids was associated with sustained responses, while cerebrospinal fluid proteomic profiling provided a complementary way to monitor treatment-associated molecular changes.
12. Reverse bioengineering of the liver: Developmental principles for next-generation liver-on-a-chip systems
Despite major advances in liver-on-a-chip and organoid technologies, most current in vitro liver models remain limited. A recent article argued that these limitations are fundamentally conceptual rather than purely technical.
Reverse bioengineering is introduced as a unifying design framework for liver-on-a-chip systems, in which human liver development is treated as the primary engineering blueprint rather than adult hepatic phenotype as the endpoint. Existing cell sources, liver organoids, and liver-on-a-chip platforms are critically evaluated, demonstrating that each captures complementary but incomplete aspects of liver development. The author also presents future directions, highlighting developmentally coordinated multi-organ systems, quantitative developmental benchmarks, and the emerging role of multi-omics-enabled digital twins and AI in guiding and interpreting liver-on-a-chip design.
Read more in Communications Biology
WORTH (RE)SHARING
Patient-derived organoids enable ex vivo drug-response profiling for precision medicine in bladder cancer, Huang et al., Precision Oncology
Nanoplasmonic aptasensing enables real-time optical monitoring of neurotransmitters in living brainstem organoids, Kim et al., ACS Nano
NIH launches new PubMed tool to strengthen research replication and reproducibility
NIS and Proteos launch TrueCourse Biosciences, a New CRO for AI-driven drug discovery, Bionity
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Opening of the BioEngineering Labs – 8 October 2026, 2:00 pm – 6:00 pm (CET), TechMed Centre, University of Twente (Netherlands)
AI Days 2026 – “AI in biopharma: no longer theoretical” – 14 October 2026, Georgia Room, NYC, hybrid
Symposium “The validation journey of NAMs: practical examples in toxicology”(3RCC & SCAHT) – 20 October 2026, 9:00 am – 5:15 pm (CET), Bern, Congress Center Kreuz (Switzerland)
Workshop on implementing EC Roadmap on phasing out animal testing in pesticides and biocides (ECHA & EFSA) – 21 October 2026, 09:30 am — 5:30 pm (CEST) & 22 October 2026, 09:00 am — 1:00 pm (CEST), Parma (Italy)
