TUCSON, Ariz., July 16, 2026 — Critical Path Institute’s® (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC) has added Crown Bioscience as its ninth member, strengthening a precompetitive effort focused on advancing the adoption, validation, and qualification of new approach methodologies (NAMs) for drug discovery and development. The coalition now includes CN Bio, Curi Bio, Emulate, InSphero, Modelus, Myhre Syndrome Foundation, Revalia Bio, VivoSphere, and Crown Bioscience, alongside a growing community of developers, end users, and regulatory colleagues working to close the gap between model creation and regulatory acceptance.
NAMs span complex in vitro and in silico systems designed to generate efficacy and safety evidence while reducing reliance on animal testing. Although many pharmaceutical companies already use these tools during discovery, translating them into regulatory science has lagged. A key challenge remains that NAMs often lack standardized workflows and shared benchmarks, making context-specific validation and qualification essential before regulators can rely on them for specific contexts of use.
Launched in spring 2026, NAMs-DC convenes model developers and engages regulators to build a qualification framework suited to advanced, human-relevant model systems. Rather than treating NAMs as generic assays, the coalition emphasizes reproducibility, performance characterization, and evidence mapping that align scientific readiness with regulatory expectations.
Crown Bioscience brings capabilities centered on patient-derived xenograft (PDX) models, tumor organoids, ex vivo patient tissue platforms, and biomarker analysis. With a large commercially available oncology model library, the company supports translational research by integrating bioinformatics and biomarker services across discovery and clinical development stages.
Importantly, these patient-derived systems can help capture tumor heterogeneity and treatment-response dynamics that are difficult to represent with conventional models. In parallel, biomarker-centric readouts can strengthen the linkage between observed model behavior and measurable biological mechanisms relevant to clinical outcomes.
NAMs-DC Executive Director Nicholas King, M.S., said the coalition’s progress depends on collaboration among developers, end-user companies, and regulators. He added that Crown Bioscience’s experience in patient-derived models and biomarker capabilities offers developers and regulators a clearer route to implementation.
Crown Bioscience Vice President, Research and Innovation Ludovic Bourré, Ph.D., emphasized that validating and qualifying NAMs requires coordinated work with regulators. He noted the coalition’s aim to advance shared qualification approaches that support broader adoption across the drug development pipeline.
As the coalition grows, NAMs-DC will continue bringing together developers and regulators to establish standards that enable confident use of complex NAMs. The overarching goal remains to make model selection and evaluation more efficient—so validated NAM tools can realize their potential for improving treatment decisions.
Subject of Research: New approach methodologies (NAMs) for drug discovery and regulatory qualification, including patient-derived models and biomarker analysis.
Article Title: C-Path NAMs-DC Adds Crown Bioscience as Ninth Coalition Member.
News Publication Date: July 16, 2026.
Web References: https://c-path.org/program/new-approach-methodologies-developer-coalition-nams-dc/ , https://c-path.org/ , http://www.crownbio.com/
References: None provided beyond the coalition and organizational descriptions.
Image Credits: None provided.
Keywords: New approach methodologies, NAMs, C-Path, NAMs-DC, Crown Bioscience, patient-derived xenografts, PDX, tumor organoids, ex vivo tissue, biomarker analysis, regulatory qualification, drug discovery, translational models.
Tags: collaborative efforts in drug developmentCrown Bioscience role in innovative testingdrug discoverydrug safety and efficacy testingin vitro and in silico modelsmodel standardization and benchmarkingNAMs validation and qualificationnew approach methodologiesnon-animal testing alternativespharmaceutical innovationregulatory acceptance of NAMsregulatory science
