Why Early Biomarker Planning Matters
Timely planning of biomarker and bioanalysis strategies is critical to successful IND submissions. Many drug development teams underestimate the time and coordination needed to develop and validate assays, especially when working with complex source materials like cell-free nucleic acids (cfNA), circulating tumor cells (CTCs), or exploratory biomarkers.
This free tool from BioTargeted Solutions helps estimate how far in advance you need to begin assay development based on your planned IND date. It accounts for different biomarker types—such as PK, PD (target engagement), diagnostic, and selection—and flags potential risks based on sample handling, global trial scope, and data readiness.
For example, if you’re collecting cfNA from plasma or exosomes, timelines may shift significantly. Similarly, global studies introduce added complexity from regional regulatory requirements.
This planner offers a high-level estimate. For more detailed timelines, clinical integration, or vendor selection strategies, we recommend a consultation. Our experience spans a wide range of therapeutic areas and assay modalities, and we’re here to help de-risk your development.
Request a consult today and get expert input on your biomarker strategy.