Fresh biopsy collection isn't just about the science—it's about strategic timing.

Biopsies are invasive. Patients hate them. You get limited shots.

So when you collect matters as much as what you collect.

Early timepoints: Look for pharmacodynamic changes when drug effects peak.
This is your window to prove mechanism of action.

Later timepoints: Hunt for resistance mechanisms after patients respond and relapse. This is where you learn why your drug stops working.

But here's the reality check:
→ Patients drop out
→ Samples will be small
→ Your embedding protocol better be bulletproof
→ QC standards need to be stringent

The patient burden math: If someone skips baseline, they shouldn't be forced into on-treatment biopsies.

But if you make everything "optional," you'll end up with 5 samples and wonder why you bothered.

Plan for realistic sample collection rates. Design accordingly.

Your future regulatory submission depends on samples you collect today—not the ones you hope to collect.