The UC Davis Novel Alternative Methodologies (NAMs) Testing Center is a nexus for collaboration between academic researchers, industry partners, and regulatory agencies to facilitate the validation of NAMs as model systems for human biology and disease research. We work directly with your team, whether you are designing, optimizing, or using a NAM, to ensure its biomedical relevance and utility while contributing to the 3R's…refinement, reduction, and replacement of animals in research.

The Center accepts investigators' requests to assess the function and output of NAMs using established in vivo models. Studies are conducted under carefully designed and rigorously controlled experimental conditions that enable benchmarking NAM's predictive power across safety, pharmacology, efficacy, and other crucial domains. We deliver clear analytical and interpretative reports of actionable results to support publications, grant applications, or regulatory submissions. All project descriptions and experimental results are confidential and remain the sole property of the requesting investigator.

Our NAMs Refinement Service is designed for teams who already have a working NAM and want to repurpose it for use in a new way—another organ system, a different exposure window, a new disease context, or a more complex combination of stressors. Instead of rebuilding your method, we focus on tuning it: testing that it still performs well, where it needs adjustment, and how the limits of its reliable use should be drawn.

Working with you, we design targeted in vivo "bridging" studies that mirror the new conditions you have in mind. Using relevant in vivo models, we adjust parameters such as dose, timing, environmental or physiological conditions, and readouts, then compare those results to your NAM's outputs. This side-by-side view helps clarify how your repurposed NAM behaves in a new context, whether any recalibration is needed, and what boundaries should be documented for responsible use.

All study designs and data stay with your team, and the outcome is a clearer map of where your NAM can be confidently extended—and where it should not be pushed without additional work. Refinement lets you get more value from methods you already trust, while keeping their expanded use grounded in real biology and aligned with 3R principles.

For investigators designing and developing New Approach Methodologies (NAMs), the UC Davis NAMs Testing Center offers NAM Co-Development Services to support the strategic planning, organization, and assembly of purpose-built NAMs with an emphasis on feasibility, functionality, and translational relevance. NAMs, conceived and developed entirely independent of the in vivo systems they aim to emulate, may overlook critical biological interactions essential to their application in biomedical research. Our Co-Development approach integrates biological and mechanistic context early in the design process, helping to prevent costly redesigns or delays later in development.

Our collaborative resources at UC Davis work directly with your team, providing expertise in complex biological systems and mechanistic pathways to guide the conceptualization and refinement of your NAM. This includes designing targeted in vivo studies and comparative analyses to evaluate readouts from individual components or to determine optimal sequencing of combinatorial NAMs arranged in series or parallel. The testing conditions intended for your NAM can be directly assessed in in vivo systems such as wild-type, knockout, or humanized mice, ensuring that data generated are biologically grounded and translationally relevant.

All project information and data generated through these services remain confidential and are the exclusive property of the requesting investigator, ensuring complete protection of intellectual property. NAM Co-Development Services accelerate the creation of functionally validated, biologically aligned NAMs ready for application in biomedical research and regulatory approval.

Benefits of working with us:

• Seamless integration with Verification and Validation Services, ensuring your NAM progresses efficiently from design to research application to regulatory-ready performance benchmarking.
• Collaborative access to UC Davis expertise in physiology, mechanistic biology, and translational model design, bridging in vitro and in vivo comparative analysis.
• Early detection of design and biological misalignments, reducing R&D costs and timelines through informed, data-driven optimization.
• Assurance of scientific rigor, reproducibility, and data integrity, supported by established protocols and quality systems that align with NAM functionality and regulatory standards.

Use our Method Verification services to assess the foundational accuracy and reliability of your Novel Alternative Methodology (NAM). Whether you are developing a new NAM, optimizing an existing one, or troubleshooting unexpected results, these services are crucial for assessing your NAM's accuracy, validity, and predictability, giving you confidence in the extent to which it represents an in vivo biological system.

We achieve this by working with you to design a tailored testing plan that meets your unique needs and specific NAM characteristics. Our process utilizes a suite of advanced testing and phenotyping platforms and analytical procedures to evaluate your NAM's research outputs. This often involves customizing comparisons against relevant in vivo models that represent the biological or pathophysiological system(s) your NAM intends to recapitulate.

Our staff will assist you in selecting an existing or designing and developing a new in vivo model (e.g., gene knockout, genetically humanized, PDX), ensuring it appropriately reflects your NAM. All data generated from this service is wholly owned by the requesting investigator, providing robust, actionable insights for immediate optimization, ensuring your NAM is refined to meet your precise scientific objectives.

Our Project Validation services are used to replicate the specific experimental observations and outputs that you found using your Novel Alternative Methodology (NAM) in a specific research project. While NAMs are invaluable for minimizing animal use and providing focused data, they may not always fully characterize or capture all the nuances of a complex biological system. These services are designed to give crucial complementary in vivo data to compare with your NAM-based research.

Whether you need to confirm preliminary findings, validate a completed study, corroborate unexpected outcomes, or demonstrate experimental findings in vivo that complement your NAM-based research, we conduct rigorous in vivo studies precisely tailored to your project's unique design specifications. This involves using a carefully designed in vivo model under specific conditions most relevant to your NAM's expected experimental outcomes.

Studies are carried out in a random, double-blind manner to ensure the utmost scientific rigor and reproducibility. All study data is owned exclusively by the requesting investigator, ensuring your proprietary control over all design specifications and experimental results. This data can provide the critical evidence needed to determine the extent to which your NAM-based research findings accurately recapitulate an in vivo system.