CN bio is proud to be part of a new Critical Path Institute (C-Path) New approach Methodologies Developers Coalition (NAMs-DC), which brings together developers to fast-track the validation, qualification and regulatory adoption of NAMs for improved drug development efficiency and reduced reliance on animals.
Who is C-Path?
C-Path is globally recognized as a pioneer in accelerating drug development. Their mission, to lead collaborations that advance better treatments for people worldwide, is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS). This independent, nonprofit was established in 2005 as a public-private partnership in response to the FDA’s Critical Path Initiative.
For more information, visit c-path.org.
Why has C-Path set up a NAMs-DC?
Pharmaceutical companies have already integrated NAMs into their workflows to overcome animal model translatability issues in safety/efficacy predictions. However, regulatory adoption has lagged and qualification standards are inconsistent across contexts of use. The NAMs-DC aims to fill this gap.
What do C-Path and the NAMs-DC plan to achieve?
Led by C-Path, the coalition will develop a framework for qualifying NAMs tools that end users can use to evaluate specific contexts of use, removing one of the central bottlenecks to regulatory adoption. C-path will also serve as a unified voice for the developer community in conversations with global regulators on the evidence required to support qualification decisions.
How will the NAMs-DC achieve their goal?
The NAMs-DC coalition will bring together in vitro model developers in a precompetitive setting alongside pharmaceutical and biotechnology end users to advance the robust qualification framework for complex in vitro models (CIVMs).
Why is the NAMs-DC important?
The purpose of this streamlined and flexible approach is to maximize impact in advancing regulatory science and therapeutic innovation.
By providing a neutral platform for framework development, C-Path aligns developers around shared qualification standards, aiming to reduce duplicative validation efforts and help regulators to evaluate methodologies with greater consistency.
For end users, a standardized framework provides a clearer path for selecting tools fit for specific contexts of use.
What does NAMs-DC participation mean for CN Bio’s customers?
For our current and future customers, we anticipate that CN Bio’s NAMs‑DC participation should translate into clearer qualification pathways, stronger regulatory alignment, and more standardized evidence expectations, making it easier to deploy our predictive human PhysioMimix® models with confidence in defined contexts of use.
Dr Tomasz Kostrzewski, CN Bio’s CSO said
“CN Bio is proud to be a founding member of the NAMs Developer Coalition and to work alongside C‑Path and fellow innovators to accelerate the regulatory adoption of human‑relevant science. For years NAMs, such as microphysiological systems have demonstrated their value in drug development to replace, fill a data gap, or confirm/ complement findings from traditional models. This coalition represents an important step toward aligning on robust, context‑of‑use‑driven qualification frameworks that give regulators and developers confidence to integrate these technologies into decision‑making.”
Learn more
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Explore validated contexts of use
Talk to our experts about using CIVMs to build better data packages
Who is involved in the NAMs-DC coalition?
NAMs-DC founding members represent a cross-section of organizations including CN Bio, Curi Bio, Emulate, InSphero, Modelus, Revalia Bio, VivoSphere, and the Myhre Syndrome Foundation. Additional members are expected to join as the coalition expands.
To learn more or inquire about membership, visit here
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