Crown Bioscience Joins C-Path’s NAMs Developer Coalition to Advance Regulatory Acceptance of Human-Relevant CRO Preclinical Models

• Crown Bioscience, a global oncology-focused CRO and JSR Life Sciences company, has joined Critical Path Institute’s New Approach Methodologies Developer Coalition (NAMs-DC) — a collaborative initiative bringing together technology developers, pharmaceutical companies, and regulatory stakeholders to accelerate the validation, qualification, and regulatory adoption of human-relevant research methods across the drug development lifecycle.

• Crown Bioscience will contribute expertise in patient-derived xenograft models, patient-derived tumor organoids, ex vivo patient tissue platforms, translational biomarker analysis, and bioinformatics, while also expanding its capabilities in organoid-based toxicology, organ-on-chip collaborations, and exploratory toxicology to improve translational predictability for biopharma sponsors.

Crown Bioscience, a global CRO specializing in oncology drug discovery and development and a JSR Life Sciences company, announced on July 16, 2026, from San Diego, California, that it has joined Critical Path Institute’s New Approach Methodologies Developer Coalition. The NAMs-DC is a collaborative initiative established by C-Path to bridge the gap between NAM development and regulatory implementation — bringing together technology developers, pharmaceutical companies, regulatory stakeholders, and scientific experts to create a more standardized and efficient framework for evaluating and deploying human-relevant methodologies across drug development.

Through its participation in the coalition, Crown Bioscience will contribute preclinical CRO expertise spanning patient-derived xenograft models, patient-derived tumor organoids, ex vivo patient tissue platforms, translational biomarker analysis, and bioinformatics. The company is also expanding its capabilities in organoid-based toxicology, organ-on-chip collaborations, and exploratory toxicology approaches — areas designed to improve translational predictability and support drug development decision-making in ways that complement or reduce reliance on conventional animal models. These capabilities sit within a broader oncology CRO platform that includes in vitro drug screening, in vivo efficacy models, spatial biology and digital pathology, genomics, and proteomics.

The NAMs-DC membership reflects a broader regulatory and scientific transition underway in preclinical CRO services, driven by mounting pressure from regulatory agencies — including the FDA and EMA — to increase adoption of human-relevant testing methodologies that better predict clinical outcomes. The FDA Modernization Act 2.0 and subsequent regulatory guidance have accelerated this shift, creating a growing need for CRO partners that can not only generate data from human-relevant model systems, but also contribute to the qualification and validation frameworks that determine whether those data will be accepted in regulatory submissions. Crown Bioscience’s inclusion in the NAMs-DC positions the company as an active contributor to that regulatory evidence-building process, rather than a downstream adopter of standards developed elsewhere.

C-Path’s NAMs-DC was established to coordinate across the regulatory qualification and adoption pathway — linking NAM developers, CRO service providers, and pharmaceutical sponsors with regulatory agencies including the FDA, EMA, and other global authorities. For preclinical sponsors outsourcing oncology programs, Crown Bioscience’s formal participation in this coalition provides increased confidence that its human-relevant model platforms are being developed and validated within a framework directly aligned with emerging regulatory expectations.

“NAMs have significant potential to improve the translational relevance and predictive value of preclinical research. By joining NAMs-DC, we are contributing our expertise in patient-derived and human-relevant model systems to support the validation and regulatory qualification of these technologies. Advancing adoption will require close collaboration between developers, industry and regulators, and we are proud to contribute to that effort.”

Ludovic Bourré, Ph.D., Vice President, Research and Innovation, Crown Bioscience