Identifying, selecting, and implementing biomarkers for your product development requires knowledge and understanding of the subject matter. An early biomarker strategy can answer critical clinical questions and develop robust clinical studies.

Planning a biomarker’s strategy can serve multiple objectives: supporting internal decision-making to understand the probability of success, interrogating a scientific hypothesis, and determining whether a target is worth pursuing or mitigating safety issues by showing a minimum threshold for a specific biological benefit.

• A biomarker objectively measures a pathological process or a biological response to treatment
• Biomarkers serve many functions in clinical trials, including patient stratification, dose selection, and safety and efficacy assessments
• Biomarkers can predict drug efficacy faster than conventional clinical endpoints and accelerate product development
• Biomarkers help with disease diagnosis and disease staging, thus increasing the success rate of drug development programs
• The FDA has approved multiple drugs based on biomarkers used as outcomes in clinical trials