NAM Testing at UC Davis | Services, Directory, AI/ML Datasets

Innovating at the Intersection of Model Systems

We provide in vivo verification, validation, repurposing, and co-development services to assess the accuracy, reproducibility, and predictability of new alternative methods (NAMs) for translational research.

- Our Mission
- Who We Are
- FAQ
- NAMs News
- What is a NAM?
- Examples
Partner Network
Contact

Our Mission

UC Davis NAM Testing provides verification, validation, repurposing, and co-development services for Novel Alternative Methodologies.

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

Director — NAMs Testing Center

Simon Atkinson, PhD

Vice Chancellor for Research, UC Davis

Simon Atkinson, PhD, is the Vice Chancellor for Research at UC Davis, bringing deep executive experience from previous roles at the University of Kansas and Indiana University–Purdue University Indianapolis. A proven academic leader with a strong background in systemwide innovation, commercialization, and institutional compliance, Dr. Atkinson oversees UC Davis’s entire research portfolio and external partnerships. He is also an accomplished molecular cell biologist and entrepreneur, holding a doctorate degree from the University of Cambridge and postdoctoral training at Johns Hopkins University.

Steering Committee

The NAMs Testing Center Steering Committee oversees the administration and management of the Center, coordinates and supervises testing protocols and procedures, and provides guidance and direction for Center activities and services.

Kent Lloyd, DVM, PhD - Professor, Department of Surgery, School of Medicine, UC Davis

Dr. Lloyd leads the UC Davis Mouse Biology Program and the Integrated Phenotype Center. He manages several high-profile, NIH-funded projects, including the Mutant Mouse Resource and Research Center (MMRRC), the Informatics Coordination and Service Center (ICSC), the Knockout Mouse Phenotype Project (KOMP2-DTCC), and the Mouse Metabolic Phenotyping Center (MMPC) Live Center at UC Davis. He also serves as the Associate Director for Shared Resources at the Comprehensive Cancer Center. He is an expert in the application of mouse genetics for translational research. Dr. Lloyd holds a veterinary medical degree from UC Davis and a doctorate in physiology from UCLA.

Kim Barrett, PhD - Vice Dean for Research | Distinguished Professor of Physiology and Membrane Biology, School of Medicine, UC Davis

Dr. Barrett heads the School of Medicine’s scientific enterprise as Vice Dean for Research. She oversees and builds large-scale partnerships essential to the success of new research methodologies. An internationally renowned scholar in gastrointestinal physiology, Dr. Barrett fosters the growth of complex medical innovations. She earned both a doctorate in biological chemistry and a bachelor’s degree from University College London.

Karen Bales, PhD - Professor, Department of Psychology and Department of Neurobiology, Physiology, and Behavior, College of Biological Sciences, UC Davis

Dr. Karen Bales directs the California National Primate Research Center. Her oversight of NIH-supported programs connects foundational science with the advancement of human health. Dr. Bales’ expertise in comparative biology and behavioral models provides a crucial framework for the analysis of complex biological systems. She holds a doctorate in biology from the University of Maryland.

Frequently Asked Questions (FAQ)

Read common questions about NAM testing, including what a NAM is, when to test a method, and how verification differs from validation.

Use this FAQ to answer the most common questions about NAM testing and jump to the most relevant service, resource, or dataset.

What is a NAM?

A NAM is a New Approach Methodology or Novel Alternative Methodology used to study biology, disease, safety, or efficacy with approaches that can reduce, refine, or replace animal use. NAMs can include cell-based systems, organoids, microphysiological systems, computational models, and integrated workflows.

Explore the NAM Directory

Why should I test my NAM?

You test a NAM when you need stronger evidence that the method is accurate, biologically relevant, reproducible, and fit for the question you want to answer. Testing a NAM helps clarify what the method can do well, where its boundaries are, and whether the outputs line up with the biology you are trying to model.

Review Verification Services

What is a NAM good for?

A NAM can be useful for mechanistic research, translational biology, toxicology, drug repurposing, biomarker work, and study design decisions. The right NAM depends on the biological system, endpoint, and level of evidence you need.

Browse development examples

How do you test a NAM?

Testing a NAM usually involves asking whether the method reflects the biology it claims to represent, whether it gives consistent outputs, and whether it performs well enough for a specific research or decision context. In practice, that can involve benchmarking against relevant in vivo systems, evaluating repeatability, and comparing outputs under defined conditions.

See Validation Services

What is the difference between verification and validation?

Verification asks whether your NAM is working accurately and reproducibly as a model system. Validation asks whether the specific findings from your NAM-based project hold up when compared with carefully designed in vivo work.

Compare verification and validation services

Why would I repurpose a NAM?

Repurposing is useful when a NAM already works in one setting and you want to adapt it to a new organ system, disease context, exposure window, or decision problem. Instead of rebuilding from scratch, you test whether the method still performs well under the new conditions.

Learn about Repurposing

When does co-development make sense?

Co-development makes sense when you are designing a new NAM, combining multiple components, or trying to build biological context into the method from the start. That approach can reduce redesign later and align the method more closely with translational or regulatory goals.

Learn about Co-Development

When should I use the NAM Directory?

Use the NAM Directory when you want to find a NAM test, compare method types, review validation status, or scan available approaches by biomarker, organ system, or domain. It is the best starting point when you are trying to understand what methods already exist.

Open the NAM Directory

When should I use the AI/ML datasets page?

Use the AI/ML datasets page when you need supporting data sources for computational toxicology, translational modeling, machine learning workflows, or hypothesis generation that sits alongside NAM testing.

Browse AI/ML datasets

How do I know which service I need?

If you need to know whether your NAM is fundamentally accurate, start with verification. If you need to confirm findings from a specific project, start with validation. If you need to adapt an existing method, look at repurposing. If you are building a method from the ground up or combining approaches, review co-development.

Contact UC Davis NAM Testing

Repurposing

Extend an existing NAM to new organ systems, exposure windows, or disease contexts with UC Davis repurposing services and in vivo bridging studies.

Our NAMs Repurposing 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. Repurposing 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 repurposing your method for precise applications? Contact us.

Co-Development

Build biologically aligned NAMs with UC Davis co-development services that integrate in vivo context and comparative testing from the start.

For investigators designing and developing New Approach Methodologies (NAMs), NAM testing at UC Davis 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 repurposing 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

Assess whether your Novel Alternative Methodology accurately and reliably reflects in vivo biology with UC Davis NAM 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

Confirm NAM-based findings with UC Davis validation services through rigorous in vivo replication studies for publications, grants, and submissions.

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.

What is a NAM?

Learn what a NAM is, how in vitro, in chemico, and in silico methods reduce animal use, and how they gain regulatory acceptance.

The acronym NAM (new approach method or novel alternative methodology) refers to an innovative in silico, in chemico, or in vitro-based scientific method for research and testing. They are intended to provide translatable research outcomes that are more relevant to human biology and disease than an animal model. Examples include human induced pluripotent stem cells, organoids and tumoroids, computational models, organ-on-a-chip technologies, and high-throughput screening methods.

There must be a direct and demonstrable reduction in the use of animals for a methodology to be considered a NAM. Once validated to accurately recapitulate in vivo biology, NAMs will become increasingly recognized by regulatory agencies as viable options for research and testing.

Examples

Explore UC Davis NAM testing examples spanning in vivo, in chemico, and in silico model evaluation and translational benchmarking.

Explore representative examples of how we help researchers verify and validate Novel Alternative Methodologies across microphysiological systems, in chemico assays, in silico models, and comparative translational studies.

🧬

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.

🧪

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.

💻

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.

📋

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

Explore the UC Davis NAM Testing partner network supporting genetics, genomics, computational biology, imaging, and translational model systems.

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

Contact UC Davis NAM Testing to discuss verification, validation, repurposing, co-development, or a new NAM research project.

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.

Name

Message

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

Regulatory Roadmap

Navigate FDA, EPA, USDA, and ICCVAM pathways relevant to NAM validation, qualification, and regulatory use with the UC Davis roadmap.

Choose the domain that matches your regulatory decision. Strong NAM uptake still depends on context of use, relevance, reliability, transferability, and clear operating boundaries. Some agencies rely on formal qualification programs, while others also accept fit-for-purpose NAM data directly in submissions for specific decisions. NAM testing at UC Davis 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 reliance on a NAM is still context-of-use-bound and evidence-driven. The key question is not whether a NAM is novel, but whether it is reliable, interpretable, technically characterized, and sufficiently validated for the specific development decision FDA will rely on. That can happen either through direct use in a submission or through a formal tool qualification pathway.

Which FDA route best matches how the NAM will be used?

Choose the option that best matches whether you are using NAM data directly in a submission or pursuing broader FDA tool qualification for reuse within a defined context of use.

NAM Use in Regulatory Submissions

For sponsors using NAM data directly in a drug-development submission or meeting package. This route focuses on fit-for-purpose validation, technical characterization, human biological relevance, transparent limitations, and early engagement with the relevant FDA review division rather than tool qualification for broad reuse.

Define the Decision and Submission Context

Start by stating what decision the NAM will inform, where the data will appear, what uncertainty it is meant to reduce, and which limits on interpretation must be carried with it.

Show Human Relevance and Technical Characterization

Describe why the NAM is biologically relevant to the drug-development question and provide enough technical detail on the platform, inputs, controls, outputs, and analysis workflow for FDA to assess whether the data are interpretable.

Build the Fit-for-Purpose Validation Package

Generate the evidence needed to show the NAM is reliable enough for its proposed use, which may include repeatability, reproducibility, robustness, transferability, comparator data, and uncertainty characterization.

Engage the Appropriate FDA Review Division Early

Use meetings and sponsor-review interactions to test whether the proposed evidence package, reporting format, and interpretation boundaries are aligned with the review context before locking the full submission strategy.

Submit the NAM Evidence With Clear Limits and Rationale

Present the NAM data so reviewers can see the scientific rationale, validation status, limitations, and why the method is fit for the specific nonclinical decision being supported.

Additional testing and validation support NAM testing at UC Davis can provide:

Submission-aligned evidence planning

We can help map the testing plan to the exact regulatory question, identify the minimum defensible evidence package, and define the limitations that need to travel with the NAM data.
Technical characterization and SOP hardening

We can help document execution conditions, controls, analysis workflows, and operating boundaries so the NAM is interpretable to reviewers rather than just novel to collaborators.
Benchmarking and orthogonal comparison studies

We can generate side-by-side datasets against comparator assays, legacy evidence, or human-relevant reference materials that strengthen a fit-for-purpose submission package.
Reproducibility and uncertainty studies

We can run targeted repeatability, robustness, and transferability studies that show where the NAM performs consistently and where the evidence remains bounded.

Innovative Science and Technology Approaches for New Drugs (ISTAND)

For novel drug development tools that do not fit existing DDT categories and are being considered for qualification. 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 NAM testing at UC Davis 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 and are intended for qualification. 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 NAM testing at UC Davis 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 NAM testing at UC Davis 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 NAM testing at UC Davis 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 NAM testing at UC Davis 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.

Roadmap Maintenance Note

Regulatory Changes Tracker

Internal summary of official changes affecting NAM validation, qualification, or regulatory use.

For site planning only, not legal or regulatory advice. Items without a dated official source and a clear process impact were excluded.

FDA Draft guidance 2026-03-19

General Considerations for the Use of New Approach Methodologies in Drug Development

FDA issued draft guidance describing a general validation framework for NAMs in drug development and explicitly encouraged use of NAM data in regulatory submissions when the method is fit for purpose and improves the human relevance and predictivity of nonclinical evidence.

This is the clearest recent FDA change separating NAM validation for submission use from formal DDT qualification.
The guidance emphasizes context of use, human biological relevance, technical characterization, reliability, and fit-for-purpose validation rather than treating qualification as the only route.
The roadmap now needs a direct submission-use route in addition to ISTAND and DDT qualification pathways.

Official source

FDA guidance document and Federal Register notice, March 19, 2026

FDA Draft guidance 2025-12-02

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies

FDA issued draft guidance for certain monospecific monoclonal antibodies stating that six-month non-human primate toxicity studies can be reduced or eliminated for specific product types and that knowledge-based risk assessments may integrate computational toxicology, organoid systems, and real-world human safety data in regulatory decision-making.

This is a product-specific change rather than a general NAM validation framework, but it materially changes how FDA can accept non-animal evidence for some antibody programs.
The draft guidance shows FDA moving from routine long-duration primate studies toward risk-based use of human-relevant NAM evidence for defined products.
Any roadmap language about FDA expectations for biologics should now distinguish general NAM validation principles from this narrower monoclonal-antibody policy track.

Official source

FDA press announcement on draft guidance, December 2, 2025

FDA Policy roadmap 2025-04-10

Roadmap to Reducing Animal Testing in Preclinical Safety Studies

FDA announced a policy shift to reduce or potentially replace animal testing for monoclonal antibodies and other drugs with NAM data, including AI-based computational models, organoid testing, and other human-relevant methods. The agency said implementation would begin immediately for IND applications, where inclusion of NAM data is encouraged, and it planned a pilot program under close FDA consultation.

This changed the practical review posture for INDs by officially encouraging NAM data in the submission process rather than treating it only as a future possibility.
The roadmap introduced an FDA pilot pathway for primarily non-animal testing strategies under agency consultation, which is a process change relevant to how sponsors seek acceptance for NAM evidence.
It also set up later guidance changes, including the December 2025 monoclonal-antibody draft guidance and the March 2026 general NAM validation draft guidance.

Official source

FDA press announcement and roadmap release, April 10, 2025

ICCVAM Validation framework update 2024-03-01

Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies

ICCVAM published an updated validation document replacing the old single-method replacement emphasis with a more flexible framework that can integrate multiple in vitro, in chemico, and in silico approaches to establish confidence for a defined application or context of use.

This is a real framework change in how cross-agency validation is described: confidence can now come from integrated evidence rather than only from one-for-one animal replacement logic.
The document strengthens the roadmap's emphasis on context of use, usefulness and limitations, and agency-specific needs and priorities.
It supports keeping ICCVAM framed as an evidence and evaluation route rather than a simple substitute-method pathway.

Official source

ICCVAM Validation Workgroup document, March 2024

NAM Directory

Search the UC Davis NAM Directory by validation status, biomarker, assay type, organ system, and research domain.

NAMs News

Follow NAM Testing news, research updates, funding developments, and regulatory discussions relevant to Novel Alternative Methodologies.

Stay informed about the latest developments in Novel Alternative Methodologies (NAMs) research. Browse current news from our ticker and explore our archive of past stories covering regulatory updates, research breakthroughs, and community developments.

📢

Advancing Drug Discovery with Complex Human In Vitro Models

Wednesday, April 8, 2026

Click Here to Register

📢

Open Questions in Laboratory Animal Science: The Next 25 Years

April 17, 2026

📢

Challenges We Face Today in Defending Animal Research

May 5, 2026

📰 Current News

Regulated use of brain organoids
New cervix-on-a-chip might help close gap in STI research
Projected global market for organs-on-a-chip to 2034
UC Berkeley's New Organ-on-a-Chip for Aging
NIH funding for NAM development
Phasing out animal models in research may risk patient safety
Can NAMs do that?
NIH eye-cell digital twin created
Human stem cell NAMs: Mapping autism pathways.
Animal models and NAMs drive innovation in pancreatic cancer research
Generating lung organoids from human iPSCs

📂 Previous News

An interview with DPCPSI Director Dr. Nicole Kleinstreuer
NC3Rs Report on incorporating NAMs into medicines development
Stem cells used to treat T1D in mice
FDA Pushes Personalized Treatments Forward
Elevating Physiology to Strengthen Research Impact
Animal Studies Continue Driving Biomedical Insight
NIH establishes Standardized Organoid Modeling Center
Are animal models replaceable today?
Pancreatic ALK7 3D microfluidic vessel-on-chip
Pericytes repair barrier integrity in blood-brain barrier NAM
Human BBB-on-a-Chip Model of astrogliosis
Authors urge everyone to get behind NAMs
Ending animal testing is not the answer
FNIH Validation & Qualification Network in design phase
Office of Research Innovation, Validation, and Application (ORIVA) launches at NIH

Show more previous news (10 more)...

AI/ML Datasets

Search AI and machine learning datasets for NAM testing, computational toxicology, translational modeling, and in silico biomedical research.

Accessibility Statement

Accessibility statement for NAM Testing at UC Davis, including WCAG 2.1 goals, accessibility features, and contact information.

Our Commitment to Accessibility

NAM Testing at UC Davis is committed to ensuring that our website is accessible to all users, including people with disabilities. We strive to comply with the Web Content Accessibility Guidelines (WCAG) 2.1, Level AA, as required by Title II of the Americans with Disabilities Act (ADA).

Accessibility Features

This website implements the following accessibility features:

Keyboard Navigation: All interactive elements are accessible via keyboard, including modal dialogs, navigation menus, and search functionality.
Screen Reader Support: Semantic HTML, ARIA attributes, and proper heading hierarchy ensure screen readers can interpret page content accurately.
Skip Navigation: A "Skip to main content" link allows keyboard users to bypass repetitive navigation.
Focus Indicators: Visible focus outlines appear on all interactive elements for keyboard navigation.
Reduced Motion: Users with motion sensitivities can enable "Reduce motion" in their operating system preferences, and all animations will be minimized.
Text Alternatives: All meaningful images include descriptive alternative text.
Color Contrast: Text and interactive elements maintain sufficient contrast ratios to meet WCAG AA standards.
Responsive Design: Content is accessible across a wide range of devices and screen sizes.
Form Accessibility: All form fields have associated labels and provide clear feedback on submission.

Conformance Status

We are actively working to maintain WCAG 2.1 Level AA conformance across all pages and functionality on this site. Accessibility is an ongoing effort, and we regularly test our content using automated tools and manual review.

Known Limitations

While we strive for full accessibility, some third-party content or embedded resources may not fully meet all WCAG criteria. We are working with our partners and vendors to address these limitations.