New Approach Methodologies Developer Coalition (NAMs-DC)

The Problem:

With the creation of the NAMs-DC, C-Path ultimately aims to expedite the development and application of new technologies for regulatory science. 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.

Get in touch: Please contact C-Path Scientific Director Graham Marsh or Project Manager Samantha Wilkins for more information about NAMs-DC.

Additional Information:

What are the Goals of the Coalition?

• 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 coalitions is for developing NAMs for drug discovery and development. Fee structure will be available upon launch.