Global CRO brings patient-derived models, organoid platforms and biomarker expertise to collaborative effort advancing regulatory acceptance of New Approach Methodologies
SAN DIEGO--BUSINESS WIRE--
Crown Bioscience is a global contract research organization (CRO) specializing in oncology drug discovery and development, today announced it has joined Critical Path Institute's (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC), 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 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. "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."
"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's participation strengthens our efforts to advance new approach methods in drug development and broader adoption of human-relevant methodologies.”
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.
Crown Bioscience'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.
About Crown Bioscience
Crown Bioscience is a global contract research organization (CRO) dedicated to accelerating drug discovery and development in oncology and immuno-oncology. We partner with biotech and pharmaceutical companies to deliver integrated preclinical and translational research solutions, supporting programs from target discovery through clinical development.
Our portfolio includes more than 2,800 patient-derived xenograft (PDX) models and approximately 1,000 tumor organoid models across 35 cancer indications, supported by expertise in in vivo, in vitro, ex vivo, and in silico research.
Combined with advanced laboratory services, multiomics capabilities, and data science, we help generate the insights needed to support confident decision-making throughout the drug development continuum.
Operating from 9 facilities across the US, Europe, and APAC, our laboratories meet the highest industry standards and include CAP-, CLIA-, and ISO 15189-accredited facilities. To learn more, visit www.crownbio.com.
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