Your biomarker strategy should be your competitive advantage—not a straightjacket.

Your biomarker vendor locked you into a rigid contract.

Due to unforeseen reasons, now your Phase 2 timeline shifted by 6 months.

Guess what? You're stuck.

This scenario plays out more often than you'd think.

Early-stage teams, eager to check the "biomarker strategy" box, rush into inflexible agreements that become anchors when (not if) things change.

The reality of drug development: Timelines shift. Protocols evolve. Sample volumes change. Regulatory feedback surprises you.

The reality of rigid contracts: None of that matters. You're paying for services you can't use and missing opportunities you didn't anticipate.

A smarter approach:
→ Build milestone-based agreements instead of fixed timelines
→ Negotiate scope adjustments without penalty clauses
→ For long studies, consider phased contracts or hybrid project structures
→ Include "pause and pivot" provisions for regulatory feedback

I've seen too many promising programs hamstrung by contracts that made sense in month 1 but became liabilities by month 18.

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