Accelerated approval is getting tougher to secure.

But a solid biomarker strategy can be your competitive edge.

Here are a few ways to use biomarkers to support the story of your drug as early as possible...

🎯 Biomarker Enrichment in Backfill
Don't wait for phase 2 to test your biomarker hypothesis. Use Phase 1 expansion cohorts to validate your enrichment strategy early.

📊 Prespecified Subgroups
Define your biomarker-positive population upfront. No post-hoc analyses. No moving goalposts. Crystal clear from protocol day one.

🔬 Fit-for-Purpose Assays
Your assays need to work in the real world—so make sure your analytical validation explores the limitations of the assay and these details are provided to the FDA to support your results when it comes to it.

⚡ Speed Matters
Accelerated approval timelines don't wait for biomarker delays. Your assay batching approach and turnaround time are essential to ensure the results come in when you need them.

The companies getting accelerated approval aren't just developing better drugs—they're building better biomarker strategies from the start.