Navigate BioPharma Services


Navigate BioPharma is a specialty clinical research organization dedicated to designing innovative biomarker solutions and customized validations for clinical development. With a technology-agnostic approach, they utilize genomic, flow cytometry, digital pathology, and ligand binding analysis methods to support drug development and manufacturing. Their mission is to deliver precise, accurate, and timely results that impact treatment decisions, pharmacodynamic understanding, and manufacturing quality, all while maintaining high standards of quality and regulatory compliance.

Industries

biotechnology
clinical-trials
health-care
medical
project-management-db17

Nr. of Employees

medium (51-250)

Navigate BioPharma Services

Carlsbad, California, United States, North America


Products

Clinical Trial Testing

Provides comprehensive support for clinical trials, including biomarker identification, pharmacodynamics, efficacy readouts, patient inclusion, and disease diagnosis and prognosis.

Biomarker Services

Offers solutions for pharmacodynamics, predictive, mechanism of action, and efficacy endpoints in clinical trials.

Flow Cytometry

Utilizes flow cytometry for immune cell composition, disease progression monitoring, cellular kinetics, and cell therapy clinical development support.

Digital Pathology Services (DPS)

Provides digital pathology assays for tumor, immune, and CAR-T cell biology analysis in human tissues.

Genomic Solutions

Delivers genomic solutions for tracking genomic alterations, transcriptome characterization, predictive/resistance solutions, and biomarker detection.

Ligand Binding

Offers ligand-binding solutions for high throughput multiplexing, neutralizing antibody testing, and non-invasive diagnostic applications.


Services

Specialty Lab Services

Navigate BioPharma offers biomarker services, bioanalytical services including immunogenicity, and diagnostics support services, focusing on pharmacodynamics, MOA, efficacy endpoints, cellular kinetics, receptor occupancy, potency, and analytical validation.

Clinical Trial Services

Their clinical trial services include clinical trial testing, project management, laboratory data management, quality assurance, and regulatory support, providing end-to-end support for clinical development.

Digital Pathology

They provide digital pathology assays for tumor, immune, and CAR-T cell biology, including multiplex detection, clinical trial support, and immuno-oncology biomarkers, with validated assays and automated quantitative analysis (AQUA) platform.

Cell and Gene Therapy

Navigate supports cell and gene therapy development with expertise in CAR-T, TCR, gene therapies, and immune-directed therapies, offering analytical validation and clinical implementation.

Genomics

They offer multiplexed quantification of CAR-T subtypes, clonal evolution assessment, and other genomic assays for cancer diagnostics and treatment, utilizing NGS, PCR, ddPCR, and other advanced techniques.

Laboratory Data Management

Their data management team provides timely, accurate, and secure data delivery, with personalized solutions for reports and data files supporting all phases of clinical trials.

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