27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop Recap
C-Path's Predictive Safety Testing team presented this workshop at the 27th NIH Tissue Chip Consortium Joint Meeting.
New Approach Methodologies Developer Coalition
Overview
Launched in the Spring of 2026, the New Approach Methodologies Developer Coalition (NAMs-DC) brings together companies developing new approach methodologies (NAMs) to advance their adoption, validation, and qualification as tools for drug discovery and development.
The Problem
Bringing new drugs to market is a resource intensive process, and many promising novel therapies fail for a lack efficacy or safety concerns when dosed into humans in clinical trials. The current standard of drug development relies heavily on animal models to run preclinical assays, but the animal data does not always translate to human relevance. With the creation of the New Approach Methodologies (NAMs) Developer Coalition, C-Path ultimately aims to expedite the development and application of these novel technologies and bridge this drug development gap and improve efficiency in regulatory science.
New Approach Methodologies (NAMs) include a broad range of methods such as complex in vitro and in silico studies. NAMs can provide researchers with drug efficacy and safety data in models that incorporate the complex physiology of organs by incorporating cell-cell interactions, 3D architectures, fluid flow, shear stresses and strains, and/or computational modeling to mimic biological function. There are myriad reasons for adopting NAMs for drug discovery, including reducing the use of animal models in assessing drug efficacy and safety and providing more human-relevant data pre-clinically. Applying these tools for regulatory science requires significant effort to validate and qualify the models for specific contexts of use. While many pharmaceutical companies have adopted them as tools for drug discovery, their applications in the regulatory space have lagged and are not standardized.
The Solution
The NAMs-DC will facilitate the progress of innovative utilization of NAM tools and close the gap in regulatory adoption. This will significantly improve the drug development process, eliminate inefficiencies, and reduce delays caused by redundant efforts. A certification program led by C-Path, a trusted innovator in this new and emerging drug development paradigm, would increase confidence in alternative methods. This would enable the creation of a database of tools and methods to allow end users to evaluate tools for specific contexts of use and unmet needs, streamlining the selection and evaluation of NAMs that have been a bottleneck to their broader adoption.
The Impact
Together, by supporting regulators and the developer community of member companies, the NAMs-DC will be positioned to drive adoption by facilitating discussions and aligning end-users with developers to make a positive impact on the adoption of NAMs. NAMs hold tremendous promise to be revolutionary tools to transform the drug discovery and development pipeline. C-Path’s New Approach Methodologies team will focus on the scalability, translation, validation and qualification of NAMs so that they are positioned for success to realize their potential.
Get in touch: Please contact C-Path Scientific Director Graham Marsh or Project Manager Samantha Wilkins for more information about NAMs-DC.
Coalition Goals
- Establish a pre-competitive coalition of in vitro model developers.
- Industry Engagement: Act as trusted partners to identify issues and develop solutions through proactively engaging pharmaceutical and biotechnology companies.
- Regulatory Engagement: Work with global health authorities to understand current needs and interests regarding the integration and CIVM adoption.
- Qualification Advancement: Advance a robust qualification framework specifically for CIVMs to facilitate their adoption by end users and regulators.
- Unified Voice for Advocacy with Government and Regulators: Engage regulatory agencies to advocate for appropriate changes to legislation, to influence funding decisions and shape policy decisions.
Membership and Fee Structure
This coalition is for developing NAMs for drug discovery and development. Membership information will be made available upon coalition launch. Until then, please contact Graham Marsh or Project Manager Samantha Wilkins for more information about NAMs-DC.
NAMs-DC Info Sheet
Check out the One Pager here. This coalition is for developing NAMs for drug discovery and development. Membership information will be made available upon coalition launch. Until then, please contact Graham Marsh or Project Manager Samantha Wilkins for more information about NAMs-DC.
