Biomarkers are important tools for successful biopharmaceutical-targeted drug development and regulatory approval. Biomarkers can be diagnostic and/or prognostic, indicative of precision drug targeting. As such, biomarkers are increasingly used to characterize disease and monitor treatment performance, enrich responsive patient enrollment in clinical trials, and support regulatory approval process and labeling.
Biomarker assay development should start early in the drug development cycle, and its timing needs to be carefully crafted upon individual development phases. This co-development process can be a particular challenge for emerging biotech companies with limited funds and resources and requires decisions to be made on how to optimize and advance biomarker assay development to support preclinical or clinical development. Other considerations include the challenging decision point of when to transition the assay into companion diagnostic development, which comes with additional regulatory requirements.
With Suzana Corritori, MD, Ph.D., MSc and Flagship COO, Meredith James, for this webinar to learn practical considerations and guidance for emerging biotech companies to navigate through successful biomarker strategy implementation into multi-faceted drug development and regulatory approval.