BioModels, LLC is a preclinical contract research organization (CRO) in Waltham, Massachusetts. The company describes itself as "a Boston-based preclinical contract research organization that specializes in the development and execution of efficacy studies in mouse and rat disease models"[S5] and states that it was "founded in 1997 by Dr. Edward Fey, Dr. Stephen T. Sonis, and Harry Barnett."[S2] This profile summarizes the models, services, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Efficacy studies in rodent disease models
The company's work centers on efficacy studies in mouse and rat models.[S5] Named therapeutic areas on the website include inflammatory and immune-mediated diseases, oncology, cancer supportive care, fibrosis, pulmonary disease, metabolic disease, immunogenicity and infectious disease, neuroscience, and cardiovascular and additional models.[S5][S8][S9][S10][S11][S13][S14] Alongside in vivo work it lists in vitro and ex vivo capabilities covering tissue and sample processing, cellular and molecular characterization, gene expression analysis, and blood and sample analysis.[S15]
The company states that it has "conducted studies in collaboration with more than 300 unique companies over the past decade."[S3] In-life monitoring equipment listed includes IVIS imaging, DEXA, telemetry, and a FlexiVent rodent mechanical ventilator; custom surgical models, microbiology and microbiome housing and sequencing, and grant support and consulting are also listed as capabilities.[S5]
Histopathology through a named partner laboratory
Histopathology and immunohistochemistry are delivered through a collaboration with an outside laboratory, DTR Labs. The company states that "the team at DTR provides non-clinical, non-GLP histology services guided by ACVP-board certified pathologists"[S7] and describes the arrangement as giving "a comprehensive experience, without having to outsource histopathology/IHC to a third party."[S7] Standard and advanced chromogenic and fluorescent staining and digital pathology on the Concentriq platform are listed.[S7] Sponsors should note that this pathology work is described by the company itself as non-GLP.
Position in the development timeline
The services described on the website are discovery and translational efficacy studies rather than regulatory safety studies. The company does not claim GLP compliance anywhere on the pages reviewed, and the histopathology page describes its pathology partner's work as "non-clinical, non-GLP."[S7] Sponsors planning an IND-enabling safety package should therefore expect to place the GLP toxicology portion of the program elsewhere, and should confirm with the company how its efficacy data will be documented for regulatory use.
Disease models
Inflammatory and immune-mediated disease models listed include MOG35-55-induced chronic EAE in C57Bl/6 mice and PLP-induced relapsing EAE in SJL/J mice; type II collagen-induced arthritis in DBA/1 mice and in Sprague Dawley, Wistar, and Lewis rats; collagen antibody-induced arthritis; DSS-induced colitis in C57Bl/6 mice and Sprague-Dawley rats; acute and chronic TNBS-induced colitis and colon fibrosis; acute graft-versus-host disease across a major MHC mismatch (C57Bl/6 donor into BALB/c host) and a humanized version using human PBMCs in NSG mice; and ovalbumin-induced atopic dermatitis.[S8] Fibrosis models cover pulmonary, dermal, liver, and radiation fibrosis.[S11]
Oncology models are grouped as syngeneic models (with cell lines including B16F10-SIY, LL/2-Red-FLuc, and GL261-Luc), cell line-derived and patient-derived xenografts, metastasis models including orthotopic and metastatic tracking, and an azoxymethane and dextran sodium sulfate inflammation-associated polyposis model.[S9] In cancer supportive care the company states that it "is internationally recognized for its groundbreaking work in oral mucositis"[S10] and lists acute and fractionated radiation-induced oral mucositis, described with the golden Syrian hamster, and radiation-induced dermatitis.[S10] Metabolic models include obesity and diabetes and diet-induced NASH using the AMLN diet;[S13] pulmonary models include allergic asthma, acute lung injury, ARDS and COPD, and pulmonary fibrosis.[S14]
For gene therapy and RNA programs the company supports AAV, plasmid, CRISPR, mRNA, RNAi and siRNA, lipid nanoparticle and lipid nanocapsule, and CAR-T modalities, and states that sponsors can "assess biodistribution and persistence of your materials via imaging (IVIS), flow cytometry, PCR, or immunohistochemistry (IHC)."[S12] Microbiome research and radiation countermeasure work for acute radiation syndrome are also listed.[S5]
Quality, compliance, and animal welfare (as stated by the company)
Accreditation, registration, and licenses. The compliance page displays five labels: "AAALAC Accredited," "OLAW Assured," "USDA Registered," "DEA Licensed," and "MCSR Licensed," the last referring to a Massachusetts Controlled Substances Registration.[S6] The history page states that the company "has earned accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)," that it "is compliant with all U.S. Department of Agriculture (USDA) standards," and that it "is compliant with all Office of Laboratory Animal Welfare (OLAW) policies and guidelines."[S2] The cited pages do not give accreditation dates, registration numbers, or license numbers[S2][S6], so these statements cannot be checked against the underlying registries from the website alone. the five displayed labels do not include GLP[S6]. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6]
Animal welfare. The company states that it "is committed to the ethical and responsible use of animals in research and follows all US federal laws and regulations,"[S6] that it maintains an Institutional Animal Care and Use Committee and follows the Guide for the Care and Use of Laboratory Animals and the 3Rs, and that its IACUC "is required to investigate all concerns regarding the animal research program in a confidential manner without the risk or fear of reprisal," with a published contact channel for such concerns.[S6] This profile does not evaluate the company's animal care program; the statements above are the company's own.
360 Second Avenue, Waltham, MA 02451, United States[S1]
Founded
1997, by Dr. Edward Fey, Dr. Stephen T. Sonis, and Harry Barnett[S2]
Ownership
Privately held partnership; no parent company is named on the website[S2][S4]
Leadership
Daniel Lichtman (Managing Partner); Stephen T. Sonis, DMD, DMSc (Founder, Partner, Chief Scientific Officer); Gregory D. Lyng, PhD (Partner)[S4]
Facility
More than 25,000 sq ft in Waltham since 2019, after more than a decade in Watertown, MA; purpose-built with multiple vivaria, procedure rooms, and surgical suites[S2]
Staff
Headcount not verified from the cited sources
Species
Mouse and rat models; golden Syrian hamster for oral mucositis[S5][S10]
Client base (company statement)
More than 300 unique companies over the past decade[S3]
Histopathology
Delivered with DTR Labs, described by the company as non-clinical, non-GLP, with ACVP board-certified pathologists[S7]
Accreditation and licenses (labels as displayed)
AAALAC Accredited; OLAW Assured; USDA Registered; DEA Licensed; MCSR Licensed. GLP is not listed[S6]
FDA — "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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