Most Phase 1 biomarker plans cost north of $1M.

Yet I see teams rush biomarkers into the clinic that were never going to survive first contact with real patient samples.

The ones I've seen fail most often:
👉Low dynamic range in heterogeneous tumors
👉Poor reproducibility outside controlled lab conditions
👉Barely detectable in clinical samples
👉Present in <15% of your target population
👉Weak predictive signal that won't move the needle

A biomarker that works beautifully in preclinical models isn't the same as one that will hold up under the messy, variable conditions of a Phase 1 trial.

Comprehensive evaluation upfront saves more than money.
It saves programs.

What's your favorite way to rule out a biomarker?