Optimizing Biomarker-Driven Clinical Trial Design for DDR Inhibitors: Navigating Regulatory Challenges & Accelerating Approvals
Time: 1:30 pm
day: Pre-Conference Biomarker Focus Day AM
Details:
- Utilizing biomarkers to enrich DDR inhibitor trials by targeting subgroups with defective DNA repair for enhanced therapeutic response, considering the impact of new EU in vitro diagnostic regulations (IVDR) on biomarker study implementation and approvals
- Applying advanced statistical methods to address challenges in subgroup characterization, demonstrating efficacy in both biomarker-positive and negative populations
- Aligning trial designs with FDA guidelines, focusing on biomarker-defined populations to streamline and expedite DDR inhibitor approvals
