NAMs Testing Center | NAM Database, AI/ML Datasets & Validation

Innovating at the Intersection of Model Systems

We provide in vivo verification, validation, refinement, and co-development services to ensure the accuracy, reproducibility, and predictability of novel alternative methodologies (NAMs) for translational research.

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Our Mission

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.

Novel Alternative Methodologies (NAMs)—also known as New Approach Methodologies—help reduce reliance on animal models while improving the translational relevance of biomedical 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.

Who We Are

Kent Lloyd, DVM, PhD - Professor of Surgery, Center Director

Amy Yokoyama, Ph.D. - Chief Administrative Officer

Louise Lanoue, PhD - Staff Scientist, In vivo / ex vivo phenotyping

Lattha Souvannaseng, PhD - Staff Scientist, iPSC and cell models

Luis G Carvajal-Carmona, PhD - Senior Advisor, organoid models

Nancy Lane, PhD - Senior Advisor, NAMs

Steven George, PhD - Senior Advisor, organ-on-a-chip

Christopher Lucchesi, PhD - Senior Advisor, 3D bioprinting of tumoroids

Dan Port, MS - Marketing Officer

Refinement

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.

Questions about refining your method for precise applications? Contact us.

Co-Development

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.

Questions about enhancing your NAM with in vivo biological context? Contact us.

Verification Services

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.

Questions about demonstrating the foundational accuracy of your method? Contact us.

Validation Services

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.

Questions about strengthening your study with independent confirmation? Contact us.

Examples

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in vivo Assessment

Scenario: You need to confirm the predictive value of a microphysiological kidney ("chip") model.

Our Approach: We conduct a functional assessment of mouse kidney function under conditions that replicate your kidney-on-a-chip model, including filtration, clearance, reabsorption, ammoniagenesis, toxicity, gene expression, and more.

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in chemico Optimization

Scenario: You need to ensure the ability of a newly developed Direct Peptide Reactivity Assay (DPRA) to assess skin sensitization to two peptides containing either cysteine or lysine.

Our Approach: We perform skin exposure studies to peptides in wild-type mice and conduct qualitative observational and quantitative measurable assessments of inflammatory response (skin reactive color, swelling, heat, and pain) and histopathology on tissues to assess inflammatory markers.

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in silico Model Evaluation

Scenario: You've developed a Quantitative Structure-Activity Relationship (QSAR) model to predict the long-term sexually-dimorphic liver toxicity of a new weight loss drug.

Our Approach: We conduct PK/PD studies of your drug in male and female cohorts of mice over time, including measurements of body weight, clinical chemistry, and liver histopathology over multiple time points.

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Comparative Studies

Scenario: You have a project using organoids from gastric carcinomas to screen for the therapeutic effects of various chemotherapies and need to demonstrate in vivo translatability to tumors in situ.

Our Approach: We establish patient-derived xenograft (PDX) models using gastric carcinoma tissues and conduct in vivo chemotherapy studies to validate the therapeutic predictions from your organoid screening platform.

Partner Network

MBP - Creates and phenotypes genetically-altered, surgically-manipulated, and environmentally-challenged in vivo model systems.

Monarch Initiative - Integrates vast datasets of genetic and disease information enabling the validation of in silico models against large-scale, established biological data.

UC Davis High Performance Computing Core (HPC) - Provides computational resources required to validate advanced computational models.

DNA Technologies Core - Offers high-throughput genomic sequencing of biological systems.

MMPCLive - Facilitates in vivo validation of NAMs created to model the heterogeneity of diabetes, obesity, and related metabolic disorders.

West Coast Metabolomics Center - Specializes in quantitative measurement of metabolites and other small molecules.

MMRRC - The largest national repository of genetically manipulated models of human disease.

Comparative Pathology Laboratory - Conducts anatomic and clinical pathology of biological specimens across numerous species.

In Vivo Translational Imaging Core - Multi-platform anatomic and functional preclinical in vivo imaging.

CNPRC - Provides in vivo model systems and environmental conditions for research on non-human primates.

Contact Us

For additional information or to schedule a NAM Verification or Validation project, please complete and submit this form and staff will get back to you within 24 hours.

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Need immediate assistance? Call us at 530-754-CNTR (2687)

Regulatory Roadmap

Choose the domain that matches your regulatory decision. Strong NAM uptake usually moves through two linked stages: validation builds confidence in relevance, reliability, transferability, and boundaries; acceptance is the agency deciding it can rely on the method for a defined Context of Use (COU). The NAMs Testing Center focuses on the testing, benchmarking, and evidence-generation work behind that case, not the regulatory paperwork itself.

Select Your Regulatory Domain

For human drug and biologic development, FDA acceptance is COU-bound and evidence-driven. The key question is not whether a NAM is novel, but whether it is reliable, interpretable, and sufficiently validated for the specific development decision FDA will rely on.

Which FDA program fits your approach?

Choose the option that best matches how your approach is defined and how you want FDA to rely on it (Context of Use):

Innovative Science and Technology Approaches for New Drugs (ISTAND)

For novel drug development tools that do not fit existing DDT categories. The program centers on a clearly bounded COU, early FDA dialogue, and a validation package showing the tool is reliable, relevant, and usable within stated limits.

Frame the Need and Proposed COU

Use the Letter of Intent to explain the unmet development need, what decision the NAM would support, why existing tools are insufficient, and the exact COU you want FDA to evaluate.

Engage FDA Early on Validation Expectations

If admitted, use early interactions with FDA to refine endpoints, study materials, comparator strategy, performance expectations, data standards, and any questions around transferability or limitations.

Build the Qualification Plan Around Validation Modules

The Qualification Plan should show how you will establish analytical or biological validity, repeatability, reproducibility, transferability, applicability domain, and conditions of use for the stated COU.

Assemble the Full Qualification Package

Submit the complete evidence package, including datasets, analyses, uncertainty characterization, limitations, and the boundaries within which the tool can be interpreted responsibly.

Qualification Decision and Lifecycle Use

If qualified, the tool may be relied on within the stated COU. Material changes to the assay, model, software, or operating environment can require additional evidence before the same conclusion still holds.

Additional testing and validation support the NAMs Testing Center can provide:

COU-aligned validation planning

We can help turn the proposed ISTAND use case into a fit-for-purpose validation plan with defined endpoints, controls, acceptance criteria, and study boundaries.
SOP hardening and technology transfer

We can help make a novel platform more execution-ready by documenting workflows, operator steps, calibration checks, and transfer materials that reduce lab-to-lab drift.
Benchmarking and bridging datasets

We can generate comparison data against existing assays, orthogonal methods, or human-relevant reference data so the tool's value is supported by more than novelty alone.
Repeatability, reproducibility, and version-change studies

We can run targeted studies that show whether the tool stays stable across operators, runs, sites, and platform revisions.

Drug Development Tool (DDT) Qualification Program

For tools that fit established DDT categories. Qualification is still tied to a specific COU, but the review is anchored to agreed performance criteria, datasets, and evidence that the tool can be relied on across programs within that boundary.

Define the Tool Category and COU

The LOI should clearly state the tool category, the specific drug development decision it supports, the intended population or setting, and why qualification would improve decision-making.

Set Performance Criteria in the Qualification Plan

The Qualification Plan should define datasets, comparators, analysis methods, acceptance criteria, and how uncertainty, limitations, and applicability boundaries will be handled.

Generate the Confirmatory Validation Evidence

Produce the datasets that demonstrate the tool performs as expected for the stated COU, including robustness, variability, transferability where needed, and interpretability of the output.

Submit the Full Qualification Package

The full package should integrate the complete evidence story: method description, datasets, statistics, limitations, and the rationale for why the tool is ready to support the proposed decision.

Qualification Decision and Ongoing Fitness

If qualified, the DDT can be cited across submissions within the accepted COU, but continued confidence still depends on maintaining the tested operating conditions and understanding when new evidence is needed.

Additional testing and validation support the NAMs Testing Center can provide:

DDT validation study design

We can help structure the datasets, comparators, controls, and acceptance thresholds needed to test whether the tool is fit for its stated COU.
Bridging and benchmarking studies

We can generate evidence that compares the DDT against legacy measures, orthogonal assays, or clinically relevant reference datasets.
Reproducibility and transferability testing

We can run studies that show whether the tool performs consistently across operators, runs, labs, and implementation environments.
Evidence package readiness support

We can help organize the testing outputs into coherent datasets, summaries, and limitation statements that support review without claiming to draft the regulatory paperwork for you.

For industrial chemicals and pesticides, EPA generally looks for fit-for-purpose evidence that a NAM is relevant to the regulatory question, reproducible, transparent about limitations, and usable alongside other evidence streams. Acceptance often depends on the specific program context rather than a single universal designation.

Define the Decision Context and Applicability Domain

Start by identifying the endpoint, the regulatory decision the NAM is meant to inform, the chemical or product space it applies to, and the limits of interpretation that should be stated up front.

Engage the Program Early on Evidence Expectations

Early discussions with the relevant EPA program can clarify what level of validation, reporting, comparator data, and uncertainty characterization will be persuasive in that context.

Build the Fit-for-Purpose Validation Package

Generate evidence on relevance, repeatability, reproducibility, robustness, transferability, and how the NAM aligns with the decision framework the program will use.

Submit the NAM Evidence in the Right Program Pathway

Submit the evidence in the context that fits the regulatory action, such as TSCA submissions, waiver requests, pesticide programs, or another program-specific route.

EPA Review, Integration, and Follow-Up Testing

EPA may rely on the NAM directly, combine it with other evidence streams, or request additional data if the limitations are not fully resolved for the intended regulatory use.

Additional testing and validation support the NAMs Testing Center can provide:

Fit-for-purpose study design

We can help match the study design to the EPA decision context so the data answer the actual regulatory question rather than just showcasing the method.
Reference chemical and applicability domain studies

We can build the benchmarking sets needed to show where the NAM performs reliably and where extrapolation would be inappropriate.
Reproducibility, transferability, and waiver-support data

We can generate the repeatability and transfer evidence that strengthens waiver requests or program-specific proposals to use a NAM in place of additional animal testing.
Weight-of-evidence dataset generation

We can produce orthogonal or supporting datasets that help place the NAM within a larger evidence framework instead of asking it to carry every claim by itself.

For veterinary biologics, the emphasis is usually on batch release, potency, identity, or safety decisions tied to manufacturing consistency. Acceptance depends on showing that the NAM is reliable, transferable, and appropriately linked to product quality for the stated use.

Define the Intended Use and Quality Linkage

Clarify whether the NAM is meant for potency, identity, safety, serial release, or another manufacturing control, and show how the readout connects to product quality for that use.

Align Early with CVB on Study Design and Acceptance Criteria

Early discussion with the Center for Veterinary Biologics can help define expected study design, bridging strategy, acceptance windows, and any product-specific protocol constraints.

Generate Validation, Bridging, and Transferability Evidence

Build the evidence package around repeatability, reproducibility, robustness, transferability, and comparability to the existing assay or release method where required.

Submit Protocols and the Validation Package

Submit the relevant protocols, datasets, analyses, and implementation details so CVB can evaluate whether the NAM is suitable for the stated regulatory use.

Implementation, Licensure Integration, and Ongoing Monitoring

If accepted, the NAM may be tied to licensure, serial release, the Outline of Production, and ongoing quality monitoring, so post-implementation stability still matters.

Additional testing and validation support the NAMs Testing Center can provide:

Batch-release and potency study design

We can help design studies that directly test whether the NAM is suitable for the manufacturing or release decision you need it to support.
Bridging to legacy assays

We can generate side-by-side datasets against the current assay so comparability is demonstrated with the materials and lots that matter to CVB.
Transferability across operators and sites

We can test whether the method remains reliable when execution moves beyond the originating team or site.
Quality control and lifecycle evidence

We can help produce the operating range, control behavior, and follow-up testing evidence needed to keep the assay defensible after implementation.

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)

ICCVAM is a cross-agency U.S. route for methods that may support federal safety and health decisions. The emphasis is on independent scientific evaluation, reproducibility, relevance for a defined COU, peer review, and recommendations that agencies can apply within their own programs.

Define the COU and Nomination Scope

Start with a precise statement of what the NAM measures, the decision it is meant to support, the populations or materials it applies to, and the key limitations that should already be acknowledged.

Build the Pre-Validation Package

Before broader review, assemble a method package that covers protocol maturity, within-laboratory repeatability, transfer expectations, data handling, applicability domain, and the rationale for why the method is relevant to the proposed COU.

Independent and Multi-Laboratory Evaluation

ICCVAM-related review typically depends on independent assessment of reliability and relevance, often including multi-site execution or other evidence that the method performs consistently outside the originating lab.

Peer Review and Public Comment

Scientific peer review and public input help test whether the claims, limitations, and use boundaries are adequately supported by the evidence package.

Interagency Recommendations and Program Uptake

ICCVAM may issue recommendations, but each participating agency still decides whether and how to rely on the method in its own authority, guidance, or program decisions.

Additional testing and validation support the NAMs Testing Center can provide:

COU and validation gap analysis

We can help translate the proposed use into a concrete testing plan: endpoint selection, comparator strategy, key uncertainties, and the minimum data needed before cross-agency review.
SOP hardening and transfer packages

We can help convert a promising method into a study-ready protocol with operator instructions, quality controls, acceptance windows, and transfer materials other labs can execute consistently.
Reproducibility and multi-laboratory studies

We can run or coordinate repeatability, reproducibility, and transferability work so the evidence shows what the method does consistently across analysts, runs, and sites.
Benchmarking and limitations mapping

We can generate side-by-side datasets against legacy assays, reference chemicals, or human-relevant comparators and document where the NAM performs well, where it is limited, and what follow-up work is needed.

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