C-Path launches coalition to advance human-relevant drug discovery

Critical Path Institute® (C-Path) has launched a new coalition aimed at accelerating the adoption of human-relevant technologies in drug discovery and development ahead of the MPS World Summit later this month.

The New Approach Methodologies Developer Coalition (NAMs-DC) brings together companies developing new approach methodologies (NAMs) in a precompetitive public-private initiative focused on improving validation, qualification and regulatory adoption of emerging scientific tools.

The coalition will formally launch ahead of the MPS World Summit, happening during the week of 25 May 2026.

Addressing challenges in drug development

Developing new medicines is an expensive and lengthy process, with many therapies failing during clinical trials because safety or efficacy concerns are not identified during animal testing.

NAMs are designed to improve that process by generating more human-relevant data earlier in development. These technologies include complex in vitro models (CIVMs), organ chips, microphysiological systems and computational approaches that replicate aspects of human biology such as organ-level physiology, cell-to-cell interactions, three-dimensional architecture, fluid flow and computational modelling.

NAMs are designed to improve that process by generating more human-relevant data earlier in development

Pharmaceutical companies have already begun integrating NAMs into their development programmes, while regulators are also increasing support for the technologies. Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have identified NAMs as a priority area in the modernisation of drug development.

However, despite growing momentum, industry leaders say the lack of consistent qualification standards has impeaded wider regulatory acceptance.

Coalition aims to standardise qualification

C-Path said the coalition was created to address that challenge by developing a qualification framework specifically for CIVMs and related technologies.

The initiative will also work closely with pharmaceutical and biotechnology companies while acting as a collective voice for developers in discussions with regulators worldwide.

Under the framework, end users would be able to assess which tools are most appropriate for specific applications, helping remove barriers to broader regulatory adoption.

“The launch of NAMs-DC marks a turning point for the integration of human-relevant science into regulatory drug development,” said Klaus Romero, Chief Executive Officer of C-Path. “For decades, the field has needed a neutral convener to translate the promise of new approach methodologies into validated, qualified tools that regulators and developers can rely on with confidence. Through this coalition, C-Path is bringing together the developers advancing this science with the sponsors, regulators and those with lived experience who will benefit from it.”

Supporting regulatory confidence

According to C-Path, aligning developers around shared qualification standards could reduce duplicated validation efforts and improve consistency in regulatory evaluations.

The organisation said a standardised framework would help companies select the most appropriate tools for applications such as assessing hepatotoxicity, modelling cardiac function, evaluating drug transport across biological barriers and studying disease-specific tissue responses.

According to C-Path, aligning developers around shared qualification standards could reduce duplicated validation efforts and improve consistency in regulatory evaluations

The framework is also intended to improve communication between technology developers and regulators regarding the evidence needed to support qualification decisions.

“NAMs developers have built remarkable technologies and the path from a promising platform to a regulatory-ready tool has often been fragmented, with each developer navigating qualification on their own,” said Dr Graham Marsh, Scientific Director at C-Path and a programme lead for NAMs-DC. “The coalition gives this community a structured way to share learnings, align on qualification approaches and engage regulators with a coordinated voice.”