Crown Bioscience Joins C-Path's NAMs Developer Coalition to Advance Human-Relevant Models in Oncology Drug Development
核心洞察
Crown Bioscience (搜索) has joined C-Path's New Approach Methodologies Developer Coalition (NAMs-DC) to accelerate regulatory acceptance of human-relevant preclinical models.
The global CRO will contribute expertise in PDX models, tumor organoids, ex vivo tissue platforms, translational biomarkers, and bioinformatics to the collaborative initiative.
NAMs-DC aims to bridge the gap between NAM development and regulatory implementation through collaborative research and qualification initiatives.
Crown Bioscience (搜索), a global contract research organization (CRO) specializing in oncology drug discovery and development, announced on July 16, 2026, that it has joined the Critical Path Institute's (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC). The coalition is a collaborative initiative dedicated to advancing the validation, qualification, and regulatory adoption of innovative human-relevant research methods. Crown Bioscience joins a growing community of technology developers, pharmaceutical companies, regulatory stakeholders, and scientific experts working to accelerate the adoption of New Approach Methodologies (NAMs) across drug discovery and development.
Through its participation in NAMs-DC, Crown Bioscience (搜索) will contribute expertise spanning patient-derived xenograft (PDX) models, patient-derived tumor organoids, ex vivo patient tissue platforms, translational biomarker analysis, and bioinformatics. The company is also expanding its capabilities across organoid-based toxicology, organ-on-chip collaborations, and exploratory toxicology approaches designed to improve translational predictability and support drug development decision-making.
"NAMs have significant potential to improve the translational relevance and predictive value of preclinical research," said Ludovic Bourré, Ph.D., Vice President, Research and Innovation at Crown Bioscience (搜索). "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."
Crown Bioscience's Scientific Capabilities
Crown Bioscience (搜索) brings a substantial portfolio of preclinical models to the coalition. The company maintains more than 2,800 patient-derived xenograft (PDX) models and approximately 1,000 tumor organoid models across 35 cancer indications. These models are supported by expertise in in vivo, in vitro, ex vivo, and in silico research, combined with advanced laboratory services, multiomics capabilities, and data science. The company operates from nine facilities across the US, Europe, and APAC, with laboratories meeting the highest industry standards, including CAP-, CLIA-, and ISO 15189-accredited facilities.
The NAMs-DC Mission
The NAMs-DC was established by C-Path to help bridge the gap between NAM development and regulatory implementation. Through collaborative research, regulatory engagement, and qualification initiatives, the coalition works to create a more standardized and efficient framework for evaluating and deploying innovative technologies across the drug development lifecycle.
"At C-Path, we believe the fastest route to better therapies is through collaboration among technology developers, industry and regulators," said Nicholas King, M.S., Executive Director of the NAMs-DC. "Crown Bioscience (搜索)'s participation strengthens our efforts to advance new approach methods in drug development and broader adoption of human-relevant methodologies."
Strategic Significance
Crown Bioscience (搜索)'s participation reflects its commitment to advancing translational research and supporting the development of more predictive, human-relevant approaches that help bridge the gap between preclinical research and clinical outcomes. By contributing patient-derived and human-relevant model systems to the coalition's qualification and validation efforts, the company aims to support the broader regulatory acceptance of NAMs, which have the potential to improve how preclinical research translates into clinical success in oncology drug development.