Biomarker Discovery & Validation2018-06-20T07:40:44+00:00

THE SMART SOLUTION FOR

PRECLINICAL DEVELOPMENT

BIOMARKER DISCOVERY & VALIDATION

Noble’s scientific team combines a deep understanding of cancer signaling pathways with public and proprietary genomic data across a compendium of cell lines and clinical samples to identify and validate biomarkers associated with drug response and efficacy.

  • For each project, a genotypically diverse cell line panel is selected for identification of candidate biomarkers associated with inhibition or resistance of the study drug across multiple indications. In silico profiling of the cell line panel is used to identify a molecular profile associated with sensitivity to the targeted drug.

  • Each cell line is treated with the study drug and analyzed with proprietary in vitro protein expression and genomic assays to further define the specific biomarkers of drug response and uncover possible new disease indications.

  • Noble’s expertise in animal models is then used to provide in vivo validation of pharmacodynamic markers and to characterize on-target dependencies of the client’s drug.

Molecular Tumor Profiling

We will help you develop a biomarker discovery and/or validation strategy that may include:

  • Discovery of RNA or protein-based biomarkers that track disease or drug activity
  • Identification of qualifying biomarkers using our extensive biomarker database and well-characterized cancer cell lines
  • Drug/biomarker pairing and validation studies
  • Pharmacodynamic modeling of response biomarkers in animal models for candidate selection, safety evaluation and patient dosing strategies
  • Evaluation of combination therapies for response in target pathways
  • Biomarker “fit for purpose” validation

Proven Expertise

We have experience with a variety of mammalian species used for vaccine and drug development. Our studies range from single digit to hundreds of animals.

Our scientists, with over 15 years of GLP experience, provide all aspects of the GLP process from design to regulatory support of your IND, IDE or PMA FDA submission.

FIND OUT MORE!