Crown Bioscience has become the ninth member of the Critical Path Institute’s NAMs Developer Coalition, contributing patient-derived xenograft models, tumour organoids and biomarker analysis capabilities.
Crown Bioscience has joined the Critical Path Institute’s (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC), strengthening efforts to increase the use of human-relevant research models in drug discovery and regulatory science.
The company becomes the ninth member of the coalition, contributing expertise in patient-derived models and biomarker analysis to support the development, validation and regulatory qualification of new approach methodologies (NAMs).
Crown Bioscience joins existing members CN Bio, Curi Bio, Emulate, InSphero, Modelus, Myhre Syndrome Foundation, Revalia Bio and VivoSphere, alongside a wider community of technology developers, pharmaceutical companies and regulatory organisations working to improve acceptance of NAMs across the medicines development process.
Supporting alternatives to animal testing
New approach methodologies encompass a range of technologies, including advanced laboratory-based and computer-based models, that can generate data on the safety and effectiveness of potential medicines while reducing reliance on animal testing.
Although many pharmaceutical companies already use these approaches during the early stages of drug discovery, their use in regulatory decision-making is not as common place due to standards for validation and qualification not being widely established.
New approach methodologies encompass a range of technologies, including advanced laboratory-based and computer-based models
NAMs-DC was launched in spring 2026 to bring together technology developers, engage with regulators and establish qualification frameworks that could support broader regulatory acceptance of these methods.
Crown Bioscience brings extensive capabilities in patient-derived xenograft (PDX) models, tumour organoids, ex vivo patient tissue platforms and biomarker analysis. The company also maintains a large collection of preclinical oncology models and provides bioinformatics services to support research from early discovery through to clinical development.
Coalition leaders believe these capabilities will broaden the range of human-relevant models available to support regulatory science and improve collaboration between developers and end users.
Collaboration seen as key
“At C-Path, we believe the fastest path to better treatments runs through collaboration among developers building these technologies, end-user companies and the regulators who evaluate them,” said NAMs-DC Executive Director Nicholas King. “Crown Bioscience has spent years building patient-derived models and biomarker capabilities. Bringing that into the coalition gives developers and regulators a clearer path to implementing these tools for use.”
Dr Ludovic Bourré, Vice President of Research and Innovation at Crown Bioscience, said collaboration would be essential to achieving wider regulatory acceptance.
“We are proud to join C-Path’s NAMs Developer Coalition and contribute our expertise in patient-derived models, ex vivo platforms, and biomarker analysis to this precompetitive effort,” he said. “Advancing the validation and regulatory qualification of new approach methodologies requires the developer community to work in concert with regulators and we are committed to that shared goal.”
Driving regulatory acceptance
The coalition’s broader objective is to bridge the gap between technological innovation and regulatory adoption by helping establish consistent standards for evaluating complex laboratory models.
By working closely with pharmaceutical and biotechnology companies alongside global health authorities, NAMs-DC aims to make the selection, validation and qualification of new approach methodologies more efficient and reliable.
The coalition’s broader objective is to bridge the gap between technological innovation and regulatory adoption by helping establish consistent standards for evaluating complex laboratory models
C-Path’s New Approach Methodologies team is focused on improving the scalability, translation, validation and qualification of these technologies, helping ensure promising human-relevant models can be confidently adopted throughout the drug development pipeline.
As membership continues to grow, the coalition plans to strengthen collaboration between developers, industry and regulators to establish the standards needed for wider implementation of new approach methodologies, supporting the development of safer and more effective medicines while reducing dependence on animal testing.
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