Journal of Organoid and Bioscience

Biomaterials in Organoid Research: Design Principles, Functional Regulation, and Clinical Translation

Wenjing Gao — 2026-03-02

Organoids, as three-dimensional (3D) in vitro models derived from stem cells, have revolutionized biomedical research by recapitulating the physiological architecture and functional characteristics of native organs. However, the full potential of organoids in disease modeling, drug discovery, and regenerative medicine remains constrained by inherent challenges in reproducibility, functional maturation, and structural complexity—limitations predominantly attributed to the inadequacy of conventional culture microenvironments. Biomaterials have emerged as indispensable tools to address these bottlenecks, providing tunable platforms that deliver instructive biophysical and biochemical cues to modulate cell fate determination, enhance tissue-level functionality, and improve experimental reproducibility. This comprehensive review systematically elucidates the pivotal role of biomaterials in advancing organoid research, with a focus on their design rationale, mechanisms of functional regulation, and translational pathways toward clinical application. We delve into the diverse repertoire of natural and synthetic biomaterials, advanced biofabrication strategies (e.g., 3D bioprinting and microfluidics), and how engineered matrices precisely tailor mechanical stiness, biochemical composition, and electrical microenvironments to guide organoid development and functional maturation. Furthermore, we highlight the broad spectrum of clinical applications, ranging from modeling complex pathologies such as cancer and neurological disorders to enabling high-throughput drug screening and advancing regenerative therapeutic strategies. Finally, we discuss current challenges, including standardization of culture protocols, vascularization of organoids, and immune integration, and outline future perspectives for biomaterial-enhanced organoids to realize their transformative potential in precision medicine and beyond.

NIH Shift Away from Animal-Only Research Signals a Major Opportunity for Organoids

ISoOR Insight Team — 2026-03-02

In April 2025, the U.S. National Institutes of Health (NIH) announced a landmark shift that will reshape biomedical research for decades: the agency will no longer issue Notices of Funding Opportunities (NOFOs) that rely exclusively on animal models. Instead, all future funding calls must include—or explicitly permit—the use of non-animal methods (NAMs), including organoids, microphysiological systems, computational models, human-derived tissues, and advanced in vitro approaches. This policy, formalized at the first FDA–NIH “Workshop on Reducing Animal Testing” on July 7, 2025, marks an unprecedented reorientation of federal funding priorities toward human-relevant, ethical, and translationally predictive model systems. For the organoid field, the implications are vast: expanded funding, accelerated standardization, infrastructure scaling, enhanced regulatory relevance, and deeper integration into drug development and precision medicine. Yet the shift also presents scientific and practical challenges, including issues of reproducibility, biological complexity, and global regulatory acceptance. This article analyzes the motivations behind the NIH decision, its transformative significance for organoid science, the challenges ahead, and the role of standards such as ISoOR-ISOB and the newly funded Standardized Organoid Modeling (SOM) Center in shaping the next era of biomedical research.

ISoOR Gains ILAC Stakeholder Status: Advancing Global Standards in Organoid Biobanking

ISoOR Insight Team — 2026-03-02

The International Society of Organoid Research (ISoOR) has strengthened its role in shaping global standards for organoid biobanking. On September 12, 2025, ISoOR was formally accepted as a Stakeholder member of the International Laboratory Accreditation Cooperation (ILAC), the world’s leading authority on laboratory and inspection-body accreditation. Achieved just six months after the launch of the ISoOR-ISOB International Standard for Organoid Biobanking at the society’s March 2025 congress in Shanghai, this membership provides ISoOR with a platform to contribute to international accreditation discussions, align its standards with globally recognized frameworks, and support the long-term goal of establishing organoid biobanking as a robust, reproducible, and trusted platform for clinical and commercial applications.

Genmab Acquires Merus for $8 Billion: The First Organoid-Discovered Clinical Asset Drives the Largest European Oncology Deal of 2025

ISoOR Insight Team — 2026-03-02

COPENHAGEN & UTRECHT – September 29, 2025 – In the largest European oncology acquisition of 2025, Genmab A/S (Nasdaq: GMAB) has agreed to acquire Merus N.V. (Nasdaq: MRUS) for approximately $8 billion in cash, or $97.00 per share. The transaction instantly delivers full ownership of petosemtamab (MCLA-158), a first-in-class EGFR × LGR5 bispecific antibody that represents a historic milestone: it is the first therapeutic candidate discovered, prioritized, and advanced into Phase III clinical trials exclusively through patient-derived organoid (PDO) screening. With two FDA Breakthrough Therapy Designations already secured and Phase III trials actively enrolling globally, petosemtamab has rapidly emerged as one of the most promising investigational therapies in head-and-neck squamous cell carcinoma (HNSCC) and is projected to achieve multibillion-dollar peak sales. Breakthrough Therapy Designation is granted to expedite the development and review of drugs that show substantial improvement over existing therapies for serious conditions.

Development of Patient-Derived Organoids from NUT Carcinoma: A Robust and Fully Documented Culture System

Mingzhu Yin — 2026-03-02

NUT carcinoma is an aggressive, poorly dierentiated malignancy defined by NUTM1 rearrangements. Median survival remains 6–7 months and preclinical models are essentially nonexistent. Here we report the first patient-derived organoid platform for this disease. Starting material included resected tumors, pleural eusions, CTguided fine-needle aspirates, and transbronchial biopsies. Using a defined medium supplemented with Wnt3a, R-spondin-1, Noggin, FGF10, EGF, bFGF and smallmolecule inhibitors (A83-01, Y-27632, and Losmapimod), we successfully established long-term cultures from all four specimen types. Organoids retained characteristic nuclear NUT expression (≥80% positive cells), preserved the original fusion by FISH and NGS, and remained stable for at least 10 passages. Drug testing against BET inhibitors yielded clear, reproducible dose-response curves. All procedures, quality controls, and banking steps were performed according to the recently released ISoOR-ISOB international standard. This platform should facilitate mechanistic studies and drug screening for a tumor that currently lacks tractable models.

United Kingdom Launches £75 Million National Roadmap to Phase Out Animal Testing by 2030: A Defining Moment for Human-Relevant Research

ISoOR Insight Team — 2026-03-02

On 11 November 2025, the United Kingdom released its unprecedented “Roadmap for Replacing Animals in Science”, announcing a structured transition toward humanrelevant, non-animal scientific methods by 2030. Supported by £75 million in dedicated government funding, the roadmap positions organoids, microphysiological systems (MPS), AI-driven toxicology, and advanced in vitro human models as central components of future regulatory science. This article summarizes key milestones, scientific frameworks, regulatory mechanisms, and sector-wide implications of the UK roadmap. The initiative represents one of the most comprehensive national strategies for animal testing reduction ever implemented by a G7 country, oering a blueprint for global transition toward human-specific research platforms.

Major Shift in U.S. Research Policy: CDC to End All Nonhuman Primate Experiments by 31 December 2025

ISoOR Insight Team — 2026-03-02

On 21 November 2025, the U.S. Centers for Disease Control and Prevention (CDC) received an internal directive from the Department of Health and Human Services (HHS) ordering the complete termination of all in-house research involving nonhuman primates — approximately 200 macaques — by the end of the calendar year. This is the first time since the NIH chimpanzee retirement in 2015 that a major federal agency has fully shuttered an active, government-owned NHP colony. The decision, driven by persistent primate shortages, documented biosafety incidents, translational failures of NHP models, and the accelerating maturity of human-relevant alternatives (organoids, microphysiological systems, organ-on-chip platforms, and AIintegrated digital twins), constitutes one of the most far-reaching policy realignments in U.S. biomedical research since the Animal Welfare Act of 1966 and the FDA Modernization Act 2.0 of 2023. This Industry News analysis places the CDC directive in full scientific, ethical, and regulatory context, evaluates the evidence base, addresses remaining challenges, and explores the transformative opportunities this shift creates for the organoid and bioscience sectors.