NAMs News
JUNE 8-12, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. AI ‘digital twins’ are transforming heart care but will they work for women?
Heart disease remains the leading cause of death worldwide, responsible for nearly 18 million deaths each year, according to the World Health Organization (WHO). AI-powered digital twin technology could transform how doctors understand and treat heart disease. But an important scientific question is emerging: What if the medical data used to build these models are missing important biological differences between women and men?
Researchers are increasingly working to integrate these dimensions into medical research, clinical practice and healthcare education. A research project at Aix-Marseille University on patient-specific computational models of inflammatory heart disease (MYOCAR3 funded by Civis Alliance), is exploring how differences in immune responses between women and men could influence how these diseases develop and how they might appear in future digital models.
2. US EPA first update of the TSCA NAMs list since 2021
The Toxic Substances Control Act (TSCA) directs U.S. Environmental Protection Agency (EPA) to use modern, non-animal “new approach methodologies” (NAMs) whenever scientifically appropriate when evaluating chemicals, and to reduce, refine, or replace vertebrate animal testing. Using NAMs, like human cell models and advanced computer methods, helps EPA identify hazards and exposures faster and often with results that are more relevant to people.
The EPA has published its first update of the TSCA NAMs list since 2021, adding several new in vitro assays, assay batteries, testing strategies/decision frameworks, and in silico-related concepts such as profilers, cheminformatics tools, and read across frameworks.
3. ISSCR Consortium urges FDA to maintain flexible, science-driven framework for NAMs in drug development
The International Society for Stem Cell Research (ISSCR) Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry.
The consortium, a global collaboration of academic scientists, industry leaders, and regulatory experts convened by the ISSCR, welcomed the FDA’s efforts to advance the integration of NAMs into drug development while emphasizing the importance of maintaining a flexible, fit-for-purpose regulatory framework that can adapt to rapidly evolving technologies.
4. Norway establishes a 3R Centre
The Norwegian Government has provided 6 million kroner (approx. 550,000 euros) in 2026 to start the work of establishing a national 3R Centre. The investment underscores the government’s commitment to advancing 3R principles — replacement, reduction, and refinement — in life sciences research and regulatory testing. The center is expected to coordinate stakeholders, publish guidance, and support adoption of non-animal methods across public and private sectors.
The establishment of a national 3R Centre may accelerate the development and validation of alternative approaches, including in vitro systems, organoids, and computational models. In addition to guiding researchers, the center could facilitate collaborations with regulatory agencies to streamline acceptance of NAMs and reduce animal testing across the country. The initiative aligns with broader European and international 3R efforts aiming for safer, more human-relevant testing paradigms.
TOOLS, PLATFORMS, CALLS
5. FDA releases new draft guidances
This month, the Food and Drug Administration (FDA) is announcing:
- the availability of a final guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.”, providing general recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD) and establishing a harmonized assessment framework for the MIDD evidence.
Read more and download the full Guidance Document
- a draft guidance document entitled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products”, that highlights a shift toward integrated, weight-of-evidence (“knowledge-based”) risk assessments and more targeted use of toxicology studies, aiming to reduce unnecessary animal testing while maintaining patient safety and accelerating development timelines. Comments can be submitted by July 30, 2026.
Read the draft Guidance and submit comments
6. ECHA’s new collaborative platform to support EU roadmap
The European Chemicals Agency (ECHA) welcomes the European Commission’s roadmap towards phasing out animal testing for chemical safety assessments. The Agency will contribute to this initiative with its scientific and regulatory expertise by launching a new Collaborative Platform on Alternatives to Animal Testing (CP-AAT).
It will bring together regulators, industry, academia and civil society to exchange knowledge and enhance their mutual understanding on the efficient regulatory use of animal-free test methods. The platform members will also discuss and address existing scientific and technical challenges. The first meeting of the platform is taking place in Helsinki on 11 – 12 June 2026.
7. STEP4NAMS: Challenge-based NAM implementation
The European founded project STEP4NAMs has just opened a new Challenge on NAM implementation. This Challenge connects SMEs with large and mid-sized BioPharma and MedTech companies that act as Challenge Providers. Through open calls, SMEs can apply to challenges that match their expertise and technology focus. Selected SMEs work directly with the Challenge Provider to co-develop solutions that address real industrial needs and accelerate the adoption of NAMs toward market readiness.
Participating SMEs receive: four months of structured mentoring; a dedicated training package valued at €3,000; on-site collaboration opportunities with travel support; and access to investors, manufacturers, and European innovation networks. The programme combines expert-led scientific training with practical implementation support, regulatory and industry insights, and connections to a broader transnational innovation ecosystem, helping SMEs move innovative solutions closer to commercialization.
To see more calls: Check out our calls interface
INDUSTRY, BIOTECH & PARTNERSHIPS
8. CAAT Director Thomas Hartung and Insilica CEO Tom Luechtefeld have team up to launch “Evidence-based AI”
Insilica Inc. announced the publication of a new perspective in Frontiers in Artificial Intelligence titled “Evidence-based AI: from trailblazer to trustblazer?”. The paper was led by Insilica founder and CEO Dr. Thomas Luechtefeld in collaboration with Dr. Thomas Hartung of the Johns Hopkins Bloomberg School of Public Health. It introduces a formal discipline called Evidence-based AI that applies the rigorous standards of medicine and toxicology to agentic software systems.
“Trailblazing AI optimizes for performance and speed; trustblazing AI optimizes for traceability, reproducibility, and accountability”, said Dr. Luechtefeld. “We built ToxIndex to be the second kind. Every claim is bound to a source span, every run is version-pinned, and every step is auditable.”
Read the perspective in Frontiers in Artificial Intelligence
9. C‑Path announces NAM Developer Coalition (NAMs-DC)
The Critical Path Institute (C‑Path) launched in the spring of 2026 the New Approach Methodologies Developer Coalition (NAMs-DC) that brings together companies developing NAMs to advance their adoption, validation, and qualification as tools for drug discovery and development.
The objectives of this coalition are to establish a pre-competitive coalition of in vitro model developers and to build a unified voice for advocacy with government and regulators to influence funding decisions and shape policy decisions.
SCIENTIFIC DISCOVERIES & PROTOCOLS
10. Personalized therapeutic platform: Organoid models for hepatic malignancies
Patient responses to therapeutic agents in hepatic malignancies are highly variable, yet the field lacks robust in vitro models for predicting individual drug responsiveness. Patient-derived organoids (PDOs) that faithfully recapitulate the biological characteristics of parental tumors offer a promising platform for personalized drug testing.
In a new study, PDOs were successfully established from 23 of 29 patients and closely resembled the original tumors in both morphology and phenotype. Prospective clinical validation in 16 patients showed that PDOs could accurately predict treatment responses. These findings suggest that PDOs are a robust and clinically relevant tool for guiding personalized treatment selection and improving outcomes in hepatic malignancies.
Read the publication in the Journal of Translational Medicine
11. Digital twins of ex vivo human lungs enable accurate and personalized evaluation of therapeutic efficacy
Digital twins are an emerging concept in healthcare that envisions integration of molecular, physiological, functional and clinical data to create computational models of biological systems such as cells, organs and individuals. However, the lack of large, multimodal datasets has so far precluded the realization of comprehensive digital twins in medicine.
Scientists at the University of Toronto developed human lung digital twins using the largest known ex vivo lung perfusion (ELVP) dataset. Using EVLP-derived imaging, physiologic monitoring, and molecular data, researchers showed that the framework accurately models >75 parameters spanning lung physiology, biochemistry, radiography, transcriptomics, metabolomics and proteomics.
Read the article in nature biotechnology
WORTH (RE)SHARING
Japan-Asia open innovation for drug development
The Australian health agency presents a 10-year National Health and Medical Research Strategy
The Future of Medicine: Organoids – By Mario Batool
ExAdEx-Innov milestone: Patent accepted for grant in the US
Owkin to build AI agents as part of a multi-year K Pro collaboration with Sanofi
Organ chips move towards mainstream drug development, with hurdles ahead – Article in Genetic Engineering & Biotechnology News
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
ICCS 2026 Symposium – June 15, 2026 – In person (Brussels, Belgium)
From Clinical Data to Actionable Assets for Pharmaceutical R&D – June 16, 2026, 5pm (CET) – Online
Bordeaux Exposome Symposium: “Mapping the Exposome to Prevent Alzheimer’s Disease and Related Dementias.”– June 17, 2026 – In person (Bordeaux, France)
New Approach Methodologies (NAMs): Key Considerations and Applications – June 17, 2026, 5pm (CET) – Online
