Regulatory Services and Biomarker Validation

According to the FDA, a biomarker is a “defined characteristic measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.”

Biomarkers enrich clinical research, but it is critical that communication from the generation of an idea to the development of a cure be transparent. Unfortunately, confusion prevails due to inadequate terminology, which hinders the effective use and clinical relevance of biomarkers.

Only a limited number of compounds are approved as drugs, despite the countless compounds that go through the time-consuming and costly clinical development phases, not to mention the issues of demonstrable efficacy or safety. If such a drug candidate fails at a later stage, the investment losses are devastating.

Translational tools such as blood-based biomarkers can provide important information about efficacy, safety, mode of action, and response to treatment in drug development. However, many of these biomarkers lack tissue specificity, leaving gaps between disease pathology and cellular origin, making these markers not fully translatable and pharmacodynamically modulable.

Collagen fragments, however, released into the bloodstream during protein formation and degradation, reflect tissue-specific turnover. Changes in tissue turnover can be quantified and used in preclinical and clinical research. This Protein Fingerprint technology enables more accurate measurement of pharmacodynamic modulation and supports the development of drug candidates at every clinical stage.

Nordic Bioscience has developed FDA-approved biomarkers, CTX-I, a marker of bone resorption, and osteocalcin, a marker of bone formation. A third biomarker, PRO-C6, which measures the adverse effects endotrophin in Heart Failure with preserved Ejection Fraction (HFpEF), recently received a Letter of Support from the FDA.