TUCSON, Ariz., and AMSTERDAM — May 19, 2026 — In a transformative step for drug development and regulatory science, the Critical Path Institute (C-Path) has officially launched the New Approach Methodologies Developer Coalition (NAMs-DC). This novel initiative is a precompetitive, public-private partnership uniting companies dedicated to the creation and optimization of new approach methodologies (NAMs). The coalition’s goal is to expedite the adoption, validation, and regulatory qualification of these cutting-edge tools as integral components in drug discovery and development pipelines worldwide. The launch precedes the upcoming MPS World Summit, a pivotal gathering for the global microphysiological systems (MPS) community scheduled for the week of May 25, 2026.
The drug development landscape has long been challenged by high costs, protracted timelines, and a high failure rate in clinical trials, often attributable to safety or efficacy failures not predicted by traditional animal models. NAMs, including complex in vitro models (CIVMs), microphysiological systems, organ-on-a-chip platforms, and advanced computational modeling, have emerged as revolutionary technologies that simulate human physiological responses with unprecedented accuracy. These systems replicate organ-level functions by integrating multiple cell types, three-dimensional tissue architecture, fluid dynamics, and biomechanical forces, providing human-relevant data that surpasses the predictive capacity of animal models.
Pharmaceutical industry stakeholders have progressively integrated NAMs into research workflows, recognizing the potential for these tools to bridge preclinical and clinical research gaps. Concurrently, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have publicly committed to advancing NAMs as a regulatory priority, endorsing their use to improve the reliability and relevance of drug safety and efficacy assessments. Despite this regulatory encouragement, a critical obstacle remains: the absence of harmonized qualification standards that define the validation and application of NAMs across various contexts within drug development.
NAMs-DC is designed specifically to address this pivotal challenge, facilitating a collaborative ecosystem wherein developers, regulators, and end users converge to standardize qualification frameworks. This initiative focuses particularly on complex in vitro models, aiming to produce consensus-driven qualification criteria that can be universally applied. By fostering a precompetitive environment, the coalition mitigates fragmented validation efforts and promotes data and knowledge sharing, thereby accelerating the maturation and regulatory acceptance of NAMs technologies.
Under the stewardship of C-Path, NAMs-DC will develop rigorous, transparent qualification frameworks that empower end users—ranging from pharmaceutical companies to biotechnology firms—to confidently evaluate and select methods tailored to their unique contexts of use. Through a structured approach, developers will gain clarity on evidentiary requirements, and regulators will benefit from consistent, science-based evaluations, improving the integration of NAMs into regulatory decision-making processes.
Klaus Romero, M.D., M.S., FCP, CEO of C-Path, underscores the significance of this coalition as a watershed moment for the drug development sector. He emphasizes that the field has long required a neutral convener capable of bridging the gap between innovative scientific methods and the regulatory rigor needed to validate and qualify these tools. C-Path’s initiative is poised to facilitate multi-stakeholder collaboration, harnessing the combined expertise of developers, sponsors, regulators, and patient advocacy groups to transition from isolated technological breakthroughs toward a coordinated pathway for regulatory readiness.
One of the coalition’s essential contributions is the establishment of uniform qualification standards that substantially reduce redundant validation efforts among developers. This streamlining enables regulators to evaluate methodologies with enhanced consistency and confidence. The standardized framework articulates clear criteria for assessing the suitability of NAMs in broader applications, whether for interrogating hepatotoxicity, modeling myocardial function, evaluating drug permeation across biological barriers, or simulating disease-specific tissue responses. By doing so, NAMs-DC enhances regulatory dialogue, ensuring that qualification is underpinned by robust, reproducible scientific evidence.
Graham Marsh, Ph.D., C-Path’s scientific director and lead of NAMs-DC, highlights how developers of NAMs technologies, despite remarkable independent advances, have faced a fragmented regulatory qualification landscape. The coalition offers a structured forum for sharing best practices, aligning evidence generation methodologies, and creating a unified interface with regulatory bodies worldwide. This effort aims to cultivate a qualification paradigm that is transparent, grounded in rigorous science, and conducive to accelerating the regulatory incorporation of NAMs in drug development pipelines.
NAMs-DC’s founding membership embodies a diverse cross-section of organizations dedicated to advancing human-relevant drug discovery using experimental, computational, and patient-centered platforms. Members include pioneering developers such as CN Bio, Curi Bio, Emulate, InSphero, Modelus, Revalia Bio, VivoSphere, and the Myhre Syndrome Foundation. This eclectic mix represents a comprehensive spectrum of technological expertise, from organ-on-a-chip and microphysiological system development to disease modeling and computational simulations, reflecting the coalition’s commitment to encompassing broad technological modalities.
The coalition’s launch anticipates the MPS World Summit, where C-Path intends to engage the wider microphysiological systems community, elucidate NAMs-DC’s objectives, and invite further stakeholder participation. Prospective coalition members interested in contributing to this groundbreaking initiative may learn more and inquire about membership through the official website at c-path.org/nams-dc and by contacting coalition leaders Graham Marsh (gmarsh@c-path.org) and Samantha Wilkins (swilkins@c-path.org).
Founded in 2005 as a public-private partnership in response to the FDA’s Critical Path Initiative, Critical Path Institute maintains a global leadership role in facilitating collaborations that accelerate pharmaceutical innovation. With a robust network encompassing more than 1,600 scientists and regulatory officials worldwide, C-Path has generated influential consortia and projects that underpin advances in biomarker development, clinical trial simulation, and now, new approach methodologies. The institute’s global headquarters reside in Tucson, Arizona, with a European subsidiary based in Amsterdam, Netherlands, positioning it at the nexus of regulatory and scientific communities influential to drug development.
The emergence of NAMs-DC represents a critical evolution in the trajectory of regulatory science, blending technological innovation with regulatory pragmatism. By consolidating disparate development pathways and fostering a shared commitment to qualification science, the coalition is strategically positioned to unlock the full potential of human-relevant models in improving drug safety and efficacy evaluation. This initiative promises to catalyze a shift away from traditional reliance on animal models, ushering in an era where NAMs are routinely integrated into regulatory frameworks and everyday pharmaceutical research and development.
As the coalition grows, its impact is anticipated to reverberate across all facets of drug development, from early candidate screening to late-stage clinical validation. The promise of NAMs-DC lies not only in expediting regulatory acceptance but also in enhancing patient safety, reducing animal testing, and enabling more precise mechanistic understanding of drug actions within human biology. These advances collectively herald a new paradigm in biomedical innovation where science, regulation, and patient needs harmoniously converge.
Subject of Research:
New Approach Methodologies (NAMs) including complex in vitro models, microphysiological systems, organ chips, and computational models in drug development and regulatory qualification.
Article Title:
Critical Path Institute Launches NAMs Developer Coalition to Accelerate Regulatory Qualification of Innovative Toxicology and Drug Discovery Tools
News Publication Date:
May 19, 2026
Web References:
https://c-path.org/nams-dc
Keywords:
New Approach Methodologies, NAMs, complex in vitro models, microphysiological systems, drug discovery, regulatory science, drug development, qualification framework, Critical Path Institute, organ-on-a-chip, computational modeling, pharmaceutical innovation
