Critical Path Institute launches developer coalition to accelerate the qualification of new approach methodologies

19 May 2026

Critical Path Institute® (C-Path) announced the launch of the New Approach Methodologies Developer Coalition (NAMs-DC), a public-private initiative bringing together companies that develop new approach methodologies (NAMs) to accelerate their adoption, validation, and qualification as tools for drug discovery and development. 

C-Path is an independent, nonprofit supported by the FDA and non-government sources, that has established numerous international consortia, programs and initiatives to advance better treatments. Current NAMs-DC founding members include CN Bio, Curi Bio, Emulate, InSphero, Modelus, Revalia Bio, VivoSphere, and the Myhre Syndrome Foundation. Additional members are expected to join as the coalition continues to expand.

NAMs‑DC arrives at a time when regulatory efforts by the FDA and EMA to prioritise NAMs in drug development gain pace, and pharmaceutical companies make NAMs a routine part of their development processes workflows. The next critical step will be translating that momentum into consistent qualification standards across contexts of use.

Similarly to the recent initiative that united European pioneers of human-based microphysiological systems to articulate a coordinated industry voice that engages with end-users, regulators and policy makers to advance the qualification and standardization of microphysiological devices, NAMs-DC brings together in vitro model developers in a precompetitive setting. Through the coalition led by C-Path, a framework for qualifying tools will be developed, allowing end users to evaluate specific contexts of use.

“The launch of NAMs-DC marks a turning point for the integration of human-relevant science into regulatory drug development,” said Klaus Romero, M.D., M.S., FCP, 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. This is precisely the kind of precompetitive, multi-stakeholder collaboration that C-Path was built to lead, and it positions the NAMs community to move from individual technical breakthroughs to a coordinated path toward regulatory readiness.”

“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 Graham Marsh, Ph.D., scientific director at C-Path and program 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. Our goal is to advance a transparent, science-based qualification framework that gives developers a clear path forward and gives regulators the confidence to integrate these tools into their decision-making for drug discovery and development.”

For weekly news, trends and insights on human‑based in vitro approaches, explore your access options.

Explore Access