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.