What's the biggest biomarker budget surprise you've encountered?

Your biomarker budget shouldn't be a black box with crossed fingers.

I've seen too many Phase 1 programs hit multi-millions in biomarker costs because the initial budget missed critical details.

Here's what actually drives your numbers:

👉 Sample acquisition. Be specific about acquisition percentages—don't inflate budgets assuming 100% sample capture when 70-80% is realistic.

👉Assay development AND clinical testing are separate line items. Development can run $50-150K depending on complexity. Clinical testing scales with patient numbers and timepoints.

👉Build in 15-20% buffer for new technologies or pivots. The biomarker landscape moves fast—your budget should accommodate strategic shifts.

👉Smart gating saves serious money:
→ Start predictive biomarkers only at efficacious doses
→ Stop PD markers once you've confirmed target engagement (and don't need for dosing)
→ Don't test "just because we can"

Timeline your batch sizes. Most assays need minimum 20-30 samples for processing and meaningful analysis. Map this to your enrollment projections—not your wishful thinking.

The difference between a strategic biomarker budget and a hopeful one?
Strategic budgets help programs succeed. Hopeful ones drain runway.

💬 What's the biggest biomarker budget surprise you've encountered?