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Tagged: Surrogate Markers

Accelerate Drug Development with Biomarker Strategy in Orphan Diseases and Precision Medicine

June 17th, 2025 | Surrogate Markers

In the fields of orphan diseases and precision medicine, establishing a robust biomarker strategy during translational and early clinical development is key to expediting time-to-market. A well-defined biomarker plan not only streamlines regulatory approval but also aligns with FDA expectations for safety and efficacy. Discover how our expertise in biomarkers and surrogate endpoints can help […]

In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.

June 15th, 2023 | Surrogate Markers

Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.

January 10th, 2023 | Surrogate Markers

The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. While the current law and regulations permit the FDA to base the approval of a drug product […]