UC Davis NAMs Testing Center - Novel Approach Methodologies

Innovating at the Intersection of Model Systems

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

- Our Mission
- Who We Are
Examples
- Regulatory Roadmap
- NAM Directory
Partner Network
Contact
Our Mission
Who We Are
Verification
Validation
Co-Development
Examples
Regulatory Roadmap
NAM Directory
Partner Network
Contact

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.

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

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.

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.

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.

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.

Name

Message

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

Regulatory Roadmap

Explore these steps for how to work towards regulatory acceptance of your NAM

Select Your Regulatory Domain

For methods used to support human drug and biologic development. This area focuses on showing a new non‑animal test is dependable so it can help replace animal studies in drug research and review. The agency is creating clearer guidance and doing internal research to build confidence in these approaches.

What type of NAM do you have?

Choose the option that best describes your technology to see the specific regulatory pathway:

Innovative Science and Technology Approaches for New Drugs (ISTAND)

For innovative Drug Development Tools that don't fit existing regulatory frameworks.

Submit Proposal

Describe NAM and context of use.

FDA Meeting

Collaborate on development plan.

Data Review

Submit validation data with FDA feedback.

Evaluation

FDA assesses program success.

Contact the NAMs Testing Center to see how we could help with:

Proposal development and innovation demonstration

Navigating the ISTAND proposal requirements can be complex. We can discuss strategies for articulating your technology's innovative aspects, identifying the most compelling use cases, and structuring your submission to align with FDA's evaluation criteria. Our conversations often explore how to position novel technologies within existing regulatory frameworks.
FDA meeting preparation and strategy

Pre-submission meetings with FDA are critical opportunities. We can explore approaches for framing your technology discussion, anticipating potential questions, and developing clear communication strategies. These conversations help you understand the regulatory landscape and prepare for productive dialogue with agency reviewers.
Validation study design for novel technologies

Designing validation studies for innovative NAMs requires balancing scientific rigor with practical constraints. We can discuss study design considerations, endpoint selection, and statistical approaches that demonstrate your technology's reliability and relevance within the ISTAND framework.
Regulatory pathway optimization

The regulatory landscape offers multiple pathways, and choosing the right approach is crucial. We can explore how different regulatory strategies might apply to your technology, discuss timing considerations, and help you understand the implications of various pathway choices for your development timeline.

Drug Development Tool (DDT) Qualification Program

Formal process for biomarkers, Clinical Outcome Assessments, and animal models under established frameworks.

Letter of Intent

Brief proposal submission.

Qualification Plan

Detailed validation plan.

Full Package

Complete validation data.

Qualification

DDT accepted for submissions.

Contact the NAMs Testing Center to see how we could help with:

Letter of Intent development

The Letter of Intent sets the foundation for your DDT qualification journey. We can discuss how to clearly articulate your biomarker or tool's intended use, explore approaches for demonstrating preliminary evidence, and navigate the strategic considerations that make a compelling case for FDA review.
Study protocol design

Protocol design for DDT qualification requires careful attention to FDA guidance and scientific standards. We can explore study design elements, discuss endpoint selection strategies, and help you understand how to structure protocols that meet regulatory expectations while addressing your specific validation needs.
Statistical analysis support

Statistical considerations are central to DDT qualification success. We can discuss analytical approaches, explore methods for demonstrating reliability and validity, and help you understand how to present statistical evidence that supports your qualification objectives within FDA's framework.
Comprehensive documentation

DDT submissions require extensive documentation that tells a cohesive story. We can discuss strategies for organizing complex data, explore approaches for presenting evidence clearly, and help you understand how to structure submissions that facilitate efficient regulatory review.

For methods that can reduce animal testing in industrial chemical safety reviews. Focus areas include sorting which chemicals need more study, using computer and rapid lab approaches to predict harm, and setting clear evidence rules so decisions still protect people and the environment.

Develop NAM

Generate reliability and reproducibility data.

EPA Consultation

Align expectations early.

Submit Data

Toxic Substances Control Act submissions or waiver requests.

Review & Decision

EPA evaluates and decides acceptance.

Contact the NAMs Testing Center to see how we could help with:

Regulatory data strategy development

Industrial chemical regulatory submissions require strategic thinking about data requirements and acceptance criteria. We can explore approaches for building compelling data packages, discuss how to navigate EPA evaluation processes, and help you understand the considerations that influence successful NAM implementation in chemical risk decisions.
Pesticide waiver applications

Waiver requests for pesticide testing represent significant opportunities to reduce animal testing. We can discuss strategies for demonstrating that alternative approaches meet regulatory standards, explore how to present scientific justifications effectively, and help you navigate EPA's waiver evaluation criteria.
QSAR model creation and validation

QSAR models offer powerful alternatives for chemical assessment, but their regulatory acceptance requires careful validation. We can explore modeling approaches, discuss validation strategies that align with EPA expectations, and help you understand how to present QSAR evidence in regulatory contexts.
Comprehensive data package preparation

EPA submissions benefit from well-organized, comprehensive data presentations. We can discuss strategies for structuring complex datasets, explore approaches for addressing regulatory requirements systematically, and help you understand how to build compelling cases for NAM acceptance.

For animal vaccines and related diagnostic products. Here the emphasis is on showing each manufacturing batch is safe, pure, and works the same—rather than proving patient benefit like in human drugs. New non‑animal tests can replace repeated animal potency or safety checks if they reliably show consistent quality and support animal welfare goals.

Develop NAM

Create method with validation data.

CVB Consultation

Engage early for guidance.

Submit Data

Use official protocols where available.

Review & Decision

CVB assesses and may approve NAM.

Contact the NAMs Testing Center to see how we could help with:

Validation studies for vaccines and diagnostics

Veterinary biologics validation requires understanding both scientific and regulatory complexities. We can explore study design considerations specific to CVB requirements, discuss approaches for demonstrating equivalence to traditional methods, and help you navigate the unique aspects of veterinary product development.
CVB documentation preparation

USDA's Center for Veterinary Biologics has specific documentation expectations that differ from other agencies. We can discuss strategies for presenting NAM data effectively, explore approaches for addressing CVB's evaluation criteria, and help you understand the regulatory nuances of veterinary biologic submissions.
Product licensing strategy integration

Integrating NAMs into existing product licensing strategies requires careful planning. We can explore how alternative methods fit within broader development timelines, discuss regulatory timing considerations, and help you understand how to position NAMs strategically within your licensing approach.
Custom approaches for unique applications

Veterinary applications often present unique challenges that require creative regulatory solutions. We can explore innovative approaches for addressing novel situations, discuss strategies for engaging with CVB on unprecedented applications, and help you navigate uncharted regulatory territory.

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

Brings together 16 U.S. government agencies to fairly test and recommend new non‑animal methods so they can replace or reduce animal testing. This is the main place where a method can gain broad federal recognition for safety and health decision uses.

Send In Your Method

You submit your test with data showing how it works and what decisions it could support.

Independent Review

A neutral scientific team checks whether the method is reliable and meaningful for its intended use.

Public Input

Experts, companies, and the public can react, raise concerns, or support the method.

Joint Agency Decision

Representatives from multiple agencies evaluate the evidence together and decide what the method is good for.

Broader Use

Agencies start using the method in place of animal tests and it may be written into international guidance so others worldwide can use it.

Contact the NAMs Testing Center to see how we could help with:

Cross-agency strategy design

Reviews involve many federal groups with different priorities. We can talk through how to present your method so each group sees clear value and how to keep communication simple and consistent.
ICCVAM nomination packages

Your submission needs to clearly show the method works, when it should (and should not) be used, and that others can repeat it. We can help structure the evidence and highlight strengths without jargon.
Multi-laboratory validation coordination

Often several labs must run the same study. We can help plan how to share protocols, track consistency, and handle differences so your data set is solid and trusted.
Federal agency communication facilitation

Each agency cares about slightly different risk or safety questions. We can help you tailor plain, direct messages that answer those questions and build confidence.