Solution

New Approach Methodologies

New Approach Methodologies (NAMs) offer the potential for faster, more human-relevant decision-making. Battelle makes that potential practical—pairing objective, platform-agnostic guidance with deep scientific and quality expertise to help teams select, apply, and validate and/or qualify NAMs effectively and with confidence.

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From Discovery to Impact

NAMs apply advanced in vitro and microphysiological systems to generate earlier, more human-relevant evidence of safety, efficacy, and biological response. As organizations integrate these methods, identifying the right tools, producing consistent data, and meeting regulatory expectations can be difficult

Battelle helps ensure methods are aligned with the right questions, data is generated with clarity and consistency, and results can be trusted by operational, scientific, and regulatory stakeholders. Our work gives teams confidence in the evidence NAMs produce and a partner committed to translating them into real-world impact.

Human-Relevant Systems Built for Decision-Ready Evidence

Battelle’s portfolio of advanced microphysiological systems (MPS) and human relevant in vitro models provides a powerful foundation for generating earlier, clearer evidence of safety, efficacy, and biological response. These predictive models deliver high fidelity insight and support key applications in pharmaceuticals, chemical safety, infectious disease, neurology, and exposure science. Through Battelle’s scientific rigor, context-of-use development, and reproducible methods, this portfolio delivers decision-ready data organizations can rely on.

Battelle’s liver MPS models human metabolism and hepatotoxicity, supporting studies of metabolite formation, injury mechanisms, and early safety risks to guide candidate selection and development decisions.

Our Air-Liquid Interface (ALI) lung systems and vapor/aerosol exposure capabilities enable controlled inhalation studies that replicate real-world respiratory conditions, supporting infectious disease research, inhalation toxicology, and hazard evaluation.

Battelle’s neuromuscular models measure muscle contraction, NMJ activity, toxin responses, and therapeutic effects—supporting potency testing, disease-relevant assessments, and early efficacy insights.

Battelle’s BNB models support studies of peripheral nerve exposure, neuropathy mechanisms, and therapeutic interactions, enabling evaluation of nerve protection, injury, and neuroinflammatory processes.

Our Approach

Adopting NAMs effectively requires more than access to advanced models—it requires a structured approach that aligns methods, data, and decisions from the start. Battelle brings a clear, disciplined process to help teams apply NAMs with purpose, generate reliable evidence, and integrate results into programs with confidence. Our framework ensures every step supports the outcome you need.

We work with you to clarify the scientific, operational, or regulatory questions that NAMs must answer—establishing a clear foundation for effective method selection.

Using objective, platform-agnostic evaluation, we identify the NAM tool(s) best suited to your goals, ensuring methods are fit-for-purpose from day one.

Battelle applies rigorous, reproducible study methods supported by deep scientific expertise, quality controls, and thorough documentation.

We analyze results with clarity—translating observations into meaningful insight and connecting outcomes to specific decision points.

Battelle helps fold NAM-generated evidence into broader program strategies, regulatory packages, or internal decision frameworks so you can move forward with confidence.