Your biomarker team shouldn't be an afterthought in trial design.

They should be at the table from day one.

Here's why:
👉 Biomarker backfill is mission-critical. If you don't have a biomarker yet, or your primary biomarker doesn't pan out (and statistically, it often won't), you need backup candidates already built into your collection strategy.

👉Statistical power for biomarkers requires upfront planning. Your sample size calculations for the primary endpoint won't magically work for biomarker analyses. Subgroup sizes, effect sizes, and analytical approaches need to be modeled before you lock your protocol.

👉Dose decisions need biomarker support. With FDA's Project Optimus pushing for optimal dosing over maximum tolerated dose, pharmacodynamic biomarkers aren't optional anymore. They're supportive evidence for dose-response relationships.

👉Fresh biopsies change everything. Optional fresh tissue collection sounds reasonable until you realize 20% uptake won't give you the statistical power you need. Your biomarker team knows which assays and which cohorts absolutely require fresh samples—and how to incentivize collection.

Too many trials get designed in silos, then scramble to retrofit biomarker strategies.

The result? Missed opportunities, protocol amendments, and biomarker datasets too small to be meaningful.

📌 When biomarker strategy drives trial design—not the other way around—you set yourself up for precision medicine success.