Over the past ten years, biomarkers have become an increasingly valuable tool in new drug development, to the point where almost no new therapeutic developments are conceived without a detailed biomarker strategy.
An effective biomarker strategy offers four key benefits:
- Biomarker outcomes can add valuable information to decision making on new therapies, particularly in early clinical phases. Because biomarker analysis is objectively measured and statistically independent of clinical endpoints, it offers a unique perspective on trial outcomes, and can significantly improve the quality of decisions to be made about candidate therapies.
- Biomarker-based stratification can be used to enrich clinical populations to reduce trial size, duration and cost.
- Biomarkers can help define, confirm or repudiate the therapy's hypothesised mechanism of action, from an early stage in development. Once again, the earlier critical information is brought to light, the better the decision making outcomes.
- Biomarkers can help to profile and stratify responders and non-responders to a therapy, and drive the development of companion diagnostics, leading to significantly improved regulatory approval and reimbursement rates.
Synexa has extensive experience in designing biomarker strategies to support clients' broader clinical development objectives. Working collaboratively with our clients, we focus on careful selection of markers to ensure results that support decision making and a significant return on investment.