Our Approach

Mission

NCAC is a national initiative that equips developers of New Approach Methodologies (NAMs) with the laboratory infrastructure and regulatory expertise needed to build a credible case for regulatory acceptance.

FDA has defined what validation means for a NAM. What's missing is an independent body to perform it, and a standing record of the result that a developer can carry from one submission to the next. NCAC fills that role: characterizing platforms against a published standard and producing benchmark data any credible validation has to be measured against. NCAC is a national resource for advancing the tools that are changing how new medicines are discovered, tested, and brought to patients.

NCAC supports developers across two stages:

Toward qualification:

NCAC provides the wet lab infrastructure to generate evidence, the regulatory science support to define a context of use and structure that evidence, and guidance for FDA engagement.

Toward adoption:

Independent validation carries weight self-validation can't. It signals to pharma partners, investors, and regulators that a tool has been held to a credible standard, and it connects developers to the drug companies who put validated tools to use.

Toward qualification:

NCAC provides the wet lab infrastructure to generate evidence, the regulatory science support to define a context of use and structure that evidence, and guidance for FDA engagement.

Toward adoption:

NCAC provides the infrastructure, the expertise, and the validation.
Developers cross the finish line.

Our launch phase centers on three deliverables that establish what regulatory-grade means for a NAM:

Pilot validation studies:

NCAC is running its first NAM validations in high-priority areas, producing the regulatory-grade evidence developers need to bring a tool in front of the FDA.

A shared terminology
framework:

Today, "NAM" lacks a consistent definition across stakeholders. NCAC is publishing a common vocabulary so developers, regulators, and industry operate from the same baseline.

An open nonclinical
data standard:

NCAC is building the infrastructure that enables the FDA to review NAM submissions under one harmonized standard, applied the same way, across developers.