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Translational Model Navigator

Identify the right preclinical and translational models for your program. Filter by modality, therapeutic area, study type, or development stage to build a model strategy that supports your IND submission.

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All 70 Translational Models

The BridgeLine Translational Model Navigator includes 70 preclinical and translational models across 5 categories: in vivo animal models, in vitro cell-based assays, organ-on-chip microphysiological systems, ex vivo tissue models, and in silico computational models. Each model includes regulatory acceptance tier, cost range, timeline, and modality-specific IND package coverage.

In Vivo (37 models)

  • Wild-Type Mouse (CD-1, C57BL/6, BALB/c) - Mouse (Mus musculus) · established regulatory acceptance · Early PK/PD, tolerability screening, dose range finding, and baseline pharmacology for small molecules, peptides, and nucleic acid therapeutics.
  • Transgenic / Knock-In Mouse (Disease-Specific) - Mouse (Mus musculus) · established regulatory acceptance · Disease-relevant efficacy studies where the therapeutic targets a specific human gene or pathway, especially for rare genetic diseases and neurodegenerative conditions.
  • Knockout Mouse - Mouse (Mus musculus) · established regulatory acceptance · Target validation, loss-of-function disease modeling (e.g., lysosomal storage disorders, metabolic diseases), and understanding on-target safety liabilities of gene-targeted therapeutics.
  • Humanized Mouse - Immune System (NSG, huPBMC, huCD34+) - Mouse (Mus musculus) · established regulatory acceptance · Immuno-oncology efficacy (checkpoint inhibitors, bispecifics, CAR-T), immunogenicity assessment of biologics, and GvHD/autoimmunity modeling.
  • Humanized-Liver Chimeric Mouse (hFRG / PXB / uPA-SCID) - Mouse (Mus musculus) · emerging regulatory acceptance · Human hepatic DMPK for species-divergent substrates (CYP3A4, UGT, CYP2D6), HBV/HCV antiviral efficacy, hepatotropic AAV/LNP biodistribution, and evaluation of hepatotoxicity risk for metabolites not generated in standard rodents.
  • Humanized Mouse - Target-Specific (Human Target Knock-In) - Mouse (Mus musculus) · established regulatory acceptance · Pharmacology and efficacy testing of monoclonal antibodies, bispecifics, and other biologics that do not cross-react with mouse orthologs.
  • Xenograft Mouse - Cell Line-Derived (CDX) - Mouse (Mus musculus) · established regulatory acceptance · First-pass in vivo efficacy screening for oncology therapeutics, dose-response characterization, and PK/PD correlation in tumor-bearing hosts.
  • Patient-Derived Xenograft Mouse (PDX) - Mouse (Mus musculus) · established regulatory acceptance · Translational efficacy studies with high clinical predictive value, biomarker-driven patient selection strategy validation, and resistance mechanism studies.
  • Syngeneic Mouse (Immune-Competent Tumor) - Mouse (Mus musculus) · established regulatory acceptance · Immuno-oncology efficacy testing (checkpoint inhibitors, oncolytic viruses, cancer vaccines), combination therapy optimization, and tumor immune microenvironment characterization.
  • Genetically Engineered Mouse Model (GEMM) - Mouse (Mus musculus) · established regulatory acceptance · Modeling tumor development and progression in a physiologically relevant immune-competent setting, testing early intervention strategies, and evaluating agents targeting the tumor microenvironment.
  • Rat (Sprague Dawley, Wistar) - Rat (Rattus norvegicus) · established regulatory acceptance · GLP repeat-dose toxicology (rodent species), safety pharmacology core battery, definitive PK/ADME studies, and dose range finding for IND-enabling packages.
  • Rabbit (New Zealand White) - Rabbit (Oryctolagus cuniculus) · established regulatory acceptance · Embryo-fetal development toxicity (ICH S5(R3)), ocular safety and pharmacology, dermal safety studies, and pyrogenicity testing.
  • Guinea Pig - Guinea pig (Cavia porcellus) · established regulatory acceptance · Dermal sensitization testing (Buehler, Maximization test), auditory safety assessment, complement-mediated reaction evaluation, and respiratory infection models.
  • Dog (Beagle) - Dog (Canis lupus familiaris) · established regulatory acceptance · GLP repeat-dose toxicology (non-rodent species), cardiovascular safety pharmacology (hERG follow-up in vivo telemetry), oral bioavailability assessment, and dose-limiting toxicity identification.
  • Non-Human Primate (Cynomolgus Macaque) - Cynomolgus macaque (Macaca fascicularis) · established regulatory acceptance · GLP toxicology for biologics requiring a pharmacologically relevant species, gene therapy biodistribution and toxicology, immunogenicity evaluation, and PK/PD for human-specific biologics.
  • Minipig (Gottingen, Yucatan) - Minipig (Sus scrofa domesticus) · established regulatory acceptance · Dermal pharmacology and toxicology, cardiovascular safety, metabolic disease models (diabetes, obesity), wound healing studies, and as an alternative non-rodent to dog.
  • Juvenile Minipig (Gottingen, JAS / Pediatric) - Minipig (Sus scrofa domesticus) · established regulatory acceptance · JAS toxicology for pediatric indications where dermal, cardiovascular, or metabolic endpoints are primary and adult-minipig data already exist. Commonly paired with juvenile rat.
  • Zebrafish (Danio rerio) - Zebrafish (Danio rerio) · supplementary regulatory acceptance · High-throughput compound screening and toxicity triage, developmental toxicity assessment, cardiovascular safety (heart rate, rhythm, morphology), and early-stage lead prioritization.
  • Ferret (Mustela putorius furo) - Ferret (Mustela putorius furo) · established regulatory acceptance · Respiratory virus infection models, vaccine efficacy/immunogenicity, and emesis assessment for compounds with potential GI toxicity.
  • Tumorigenicity Assay (Soft Agar + In Vivo NSG Persistence) · established regulatory acceptance · Assessing insertional mutagenesis and oncogenic transformation risk for lentiviral CAR-T, gene-edited cell therapies, and iPSC-derived cell therapies.
  • NASH/MASH Mouse Models (Diet-Induced & Genetic) - Mouse (C57BL/6, ob/ob, db/db) · established regulatory acceptance · Efficacy and pharmacodynamic studies for NASH/MASH therapeutic candidates, including assessment of steatosis, inflammation, ballooning, and fibrosis endpoints.
  • Intrathecal Delivery Model (NHP, Rodent) - NHP (Cynomolgus macaque), Mouse, Rat · established regulatory acceptance · Biodistribution, PK/PD, and toxicology assessment for intrathecally delivered CNS therapeutics including ASOs, AAV gene therapies, and enzyme replacement therapies.
  • Collagen-Induced Arthritis (CIA) Mouse Model - Mouse (DBA/1); rat CIA uses Dark Agouti (DA) (adjuvant-induced arthritis in Lewis is a separate model) · established regulatory acceptance · Preclinical efficacy testing of anti-inflammatory, anti-TNF, anti-IL-6, JAK inhibitor, and other immunomodulatory therapeutics targeting rheumatoid arthritis and autoimmune joint disease.
  • Experimental Autoimmune Encephalomyelitis (EAE) Mouse Model - Mouse (C57BL/6, SJL), Rat (Lewis, Dark Agouti) · established regulatory acceptance · Preclinical efficacy testing of immunomodulatory, anti-inflammatory, and remyelinating therapies for multiple sclerosis and neuroinflammatory conditions.
  • Bleomycin-Induced Pulmonary Fibrosis Mouse Model - Mouse (C57BL/6) · established regulatory acceptance · Preclinical efficacy testing of antifibrotic therapeutics for IPF and other fibrotic lung diseases, including assessment of collagen deposition, lung function, and histopathological endpoints.
  • DSS-Induced Colitis Mouse Model - Mouse (C57BL/6, BALB/c) · established regulatory acceptance · Preclinical efficacy testing of anti-inflammatory and mucosal healing therapeutics for ulcerative colitis and IBD, and evaluation of epithelial barrier protection and innate immune modulation.
  • Streptozotocin (STZ)-Induced Diabetic Model - Mouse (C57BL/6), Rat (Sprague Dawley, Wistar) · established regulatory acceptance · Preclinical efficacy testing of insulin secretagogues, GLP-1 receptor agonists, beta cell regeneration therapies, and glucose-lowering agents, as well as diabetic complication studies (nephropathy, neuropathy, retinopathy).
  • MPTP-Induced Parkinson's Disease Model - Mouse (C57BL/6), NHP (Cynomolgus macaque, Marmoset) · established regulatory acceptance · Preclinical efficacy testing of neuroprotective, dopamine-replacement, and neuroregenerative therapies for Parkinson's disease, including gene therapies and cell-based therapies targeting the nigrostriatal pathway.
  • Cotton Rat (Sigmodon hispidus) - Cotton rat (Sigmodon hispidus) · established regulatory acceptance · Preclinical efficacy and dose-finding for RSV therapeutics and vaccines, respiratory virus immunoprophylaxis evaluation, and maternal immunization studies for neonatal protection.
  • Zucker Diabetic Fatty (ZDF) Rat - Rat (ZDF fa/fa) · established regulatory acceptance · Preclinical efficacy testing of insulin sensitizers, GLP-1 agonists, SGLT2 inhibitors, and other antidiabetic therapeutics targeting Type 2 diabetes with obesity and insulin resistance.
  • Spontaneously Hypertensive Rat (SHR) - Rat (SHR/NCrl) · established regulatory acceptance · Preclinical efficacy testing of antihypertensive agents (ACE inhibitors, ARBs, calcium channel blockers, diuretics, novel targets), cardiovascular safety pharmacology, and long-term end-organ damage studies.
  • Transverse Aortic Constriction (TAC) Heart Failure Mouse Model - Mouse (C57BL/6) · established regulatory acceptance · Preclinical efficacy testing of cardioprotective agents, antifibrotic therapies, gene therapies targeting cardiac remodeling, and evaluation of novel targets for heart failure with reduced ejection fraction (HFrEF).
  • mdx Mouse Model (Duchenne Muscular Dystrophy) - Mouse (mdx, mdx/mTR) · established regulatory acceptance · Preclinical efficacy testing of dystrophin restoration therapies including AAV micro-dystrophin gene therapy, exon skipping ASOs, gene editing (CRISPR), and other DMD therapeutic approaches.
  • Woodchuck Hepatitis B Model - Woodchuck (Marmota monax) · established regulatory acceptance · Preclinical efficacy testing of HBV antivirals (nucleos(t)ide analogues, capsid assembly modulators), siRNA/ASO targeting HBV, immunomodulatory approaches, and therapeutic vaccines for chronic hepatitis B functional cure.
  • Pig Cardiovascular Model (Yorkshire/Landrace) - Domestic pig (Sus scrofa domesticus - Yorkshire, Landrace) · established regulatory acceptance · Translational cardiovascular efficacy and safety studies including myocardial infarction therapeutics, coronary stent testing, cardiac gene therapy vector delivery, cardiac device evaluation, and cardiovascular safety pharmacology in a large animal model.
  • Common Marmoset (Callithrix jacchus) - Common marmoset (Callithrix jacchus) · established regulatory acceptance · Nonclinical toxicology and pharmacology for biologics where marmoset target cross-reactivity is confirmed, CNS and rare disease programs, and situations where cynomolgus supply is constrained or compound availability is limited.
  • Laser-Induced CNV Model (Wet AMD) - Mouse (C57BL/6), Rat (Brown Norway), NHP (Cynomolgus macaque) · established regulatory acceptance · Preclinical efficacy testing of anti-VEGF agents, antiangiogenic therapies, gene therapy approaches for sustained anti-VEGF expression, and novel intravitreal drug delivery systems for wet AMD.

In Vitro (18 models)

  • Primary Human Cell Cultures · established regulatory acceptance · Human-relevant PK/ADME (hepatocyte clearance, CYP inhibition/induction), immune cell functional assays, target engagement, and mechanism-of-action confirmation.
  • Immortalized Cell Lines · established regulatory acceptance · High-throughput screening, potency/EC50 determination, reporter-based mechanism assays, manufacturing cell line development, and permeability assessment (Caco-2).
  • iPSC-Derived Cardiomyocytes · supplementary regulatory acceptance · Proarrhythmia risk assessment under FDA CiPA paradigm, cardiotoxicity screening for oncology therapeutics (ADCs, kinase inhibitors), and mechanistic cardiac safety studies.
  • iPSC-Derived Neurons · emerging regulatory acceptance · CNS target validation and engagement, neurotoxicity screening, disease modeling for neurodegeneration, and seizure liability assessment.
  • iPSC-Derived Hepatocytes · emerging regulatory acceptance · Hepatotoxicity screening in lead optimization, liver disease modeling (NASH, genetic liver diseases), and long-term repeat-exposure toxicity studies not feasible with primary hepatocytes.
  • iPSC-Derived Kidney Organoids / Proximal Tubule Cells · limited regulatory acceptance · Early nephrotoxicity screening, renal transporter assessment, and kidney disease modeling for genetic and metabolic kidney disorders.
  • Patient-Derived Organoids · emerging regulatory acceptance · Patient-stratified oncology efficacy screening, precision medicine companion diagnostics development, modeling rare diseases, and drug resistance mechanism studies.
  • 3D Spheroid Cultures · supplementary regulatory acceptance · Medium-throughput cytotoxicity and efficacy screening with improved physiological relevance over 2D, especially for oncology and liver toxicology.
  • Co-Culture Systems (Immune + Tumor, etc.) · established regulatory acceptance · Immune-mediated cytotoxicity assays (ADCC, CDC, bispecific T-cell engager activity), tumor-immune interaction modeling, and hepatic fibrosis/NASH models.
  • Reconstructed Human Skin Models (EpiDerm, Episkin) · established regulatory acceptance · Regulatory-accepted skin safety testing without animal use. OECD-validated replacement for Draize rabbit skin test.
  • Cytokine Release Assay (CRA) · established regulatory acceptance · Predicting CRS risk for bispecific antibodies, T-cell engagers, CAR-T therapies, and other immunomodulatory biologics before FIH dosing.
  • Caco-2 Permeability Assay · established regulatory acceptance · Oral drug absorption prediction and BCS classification, P-glycoprotein and BCRP efflux liability assessment, and rank-ordering compounds by intestinal permeability during lead optimization.
  • Human Liver Microsomes (HLM) · established regulatory acceptance · CYP inhibition screening for DDI risk assessment, metabolic stability half-life determination, reaction phenotyping to identify contributing CYP isoforms, and metabolite identification studies.
  • Mixed Lymphocyte Reaction (MLR) · established regulatory acceptance · Demonstrating functional immune activation by checkpoint inhibitors, bispecific antibodies, and immunomodulatory therapeutics in an allogeneic T-cell response context.
  • ADCC Reporter Bioassay · established regulatory acceptance · Lot-release potency testing, Fc engineering optimization, biosimilar comparability, and characterizing ADCC as a mechanism of action for therapeutic antibodies.
  • Air-Liquid Interface (ALI) Airway Model · established regulatory acceptance · Preclinical evaluation of inhaled therapeutics, pulmonary drug absorption and formulation testing, respiratory virus infection modeling (RSV, influenza, SARS-CoV-2), and airway inflammation/fibrosis studies.
  • Colony Forming Unit (CFU) Hematotoxicity Assay · supplementary regulatory acceptance · Predicting myelosuppressive potential and dose-limiting hematotoxicity for oncology therapeutics (ADCs, cytotoxics, PROTACs), and rank-ordering lead candidates by bone marrow toxicity during lead optimization.
  • FcRn Binding Assay (Antibody PK Prediction) · established regulatory acceptance · Predicting therapeutic antibody serum half-life, optimizing Fc-engineered variants for extended PK, biosimilar FcRn binding comparability, and rank-ordering antibody candidates by expected PK profile.

Organ-on-Chip / MPS (6 models)

  • Liver-Chip (Microphysiological System) · emerging regulatory acceptance · DILI risk prediction and mechanistic hepatotoxicity assessment, especially for compounds with clinical liver signals not detected by standard in vitro or animal models.
  • Lung-Chip (Microphysiological System) · emerging regulatory acceptance · Inhaled drug safety and efficacy testing, pulmonary drug absorption assessment, respiratory infection modeling, and pulmonary inflammation/fibrosis studies.
  • Kidney-Chip (Microphysiological System) · emerging regulatory acceptance · Nephrotoxicity risk prediction, renal transporter-mediated drug interaction assessment, and mechanistic investigation of kidney injury biomarkers (KIM-1, NGAL).
  • BBB-Chip (Blood-Brain Barrier) · limited regulatory acceptance · CNS drug penetration prediction, BBB permeability ranking, and brain-targeted delivery vehicle evaluation for therapeutics that must cross or specifically avoid the BBB.
  • Gut-Chip (Intestine MPS) · emerging regulatory acceptance · Oral drug absorption prediction, intestinal toxicity assessment, first-pass metabolism evaluation, and microbiome-drug interaction studies.
  • Multi-Organ / Body-on-Chip · limited regulatory acceptance · Multi-organ toxicity and drug-drug interaction assessment, first-pass metabolism effects on systemic exposure, and modeling complex ADME where single-organ systems are insufficient.

Ex Vivo (5 models)

  • Precision-Cut Tissue Slices (Liver, Lung) · emerging regulatory acceptance · Human-relevant organ-level toxicity assessment with intact tissue architecture, fibrosis modeling, and bridging between in vitro and in vivo toxicology data.
  • Skin Explant Models · established regulatory acceptance · Dermal drug absorption and permeation studies, skin irritation/corrosion testing, wound healing evaluation, and topical formulation development.
  • Tumor Explant Cultures · supplementary regulatory acceptance · Patient-specific drug sensitivity testing with preserved tumor microenvironment, biomarker validation, and translational pharmacology studies.
  • Perfused Organ Systems (ex vivo Perfusion) · limited regulatory acceptance · Organ-level PK and toxicity assessment with full physiological context, transplantation research, and bridging mechanistic studies between in vitro and in vivo.
  • Langendorff Isolated Perfused Heart - Rabbit, Rat, Guinea pig · established regulatory acceptance · Direct cardiac effect assessment of drug candidates on contractility, heart rate, rhythm, and coronary flow without systemic confounders, and proarrhythmic risk evaluation complementary to hERG and in vivo telemetry.

In Silico (4 models)

  • PBPK Modeling (Physiologically Based Pharmacokinetic) · established regulatory acceptance · First-in-human PK prediction, clinical DDI risk assessment, pediatric dose extrapolation, organ impairment dosing, and supporting dose selection in the IND.
  • QSP Modeling (Quantitative Systems Pharmacology) · emerging regulatory acceptance · Clinical dose-response prediction, combination therapy optimization, virtual clinical trial simulation, and supporting clinical development strategy decisions.
  • QSAR / In Silico Toxicology · established regulatory acceptance · Mutagenicity assessment of impurities (ICH M7 requirement), early toxicity hazard identification, structure-activity screening of compound libraries, and regulatory-compliant impurity qualification.
  • AI/ML Predictive Models · limited regulatory acceptance · Large-scale compound screening and prioritization, toxicity prediction across multiple endpoints, clinical trial outcome prediction, and augmenting decision-making at portfolio level.