Milestones Aren't Typically Missed Because of Science

The pattern we see is that nobody owns the boundaries

In specialist-led organizations, accountability lives within functions but between the functions it can disappear. Your Head of's know the targets, but who owns the decision to move from lead optimization to IND-enabling studies? Who's responsible when your CRO's timeline doesn't align with your board's expectations?

When no one has clear authority to make the call, scope expands and timelines slide because decisions wait for consensus that will never form.

Diagnostic Questions to Ask Today

• Who decides whether we're IND-ready

• Who asks if we're at the next major milestone?

• If the answer involves three or more people, or “we'd need to discuss it as a group,” accountability is diffuse.

• Do decisions wait when one key person is out for a week? If yes, you have bottlenecks.

Split Scientific Judgment from Execution Accountability

Instead of functional silos, assign two distinct roles per major milestone:

• Asset Leads own the scientific thesis, the value story, and what “success” means at each inflection point.

  • Makes the judgment call, “Is the data sufficient to move forward?”

• Program Leads own the execution plan, manages dependencies across functions, and surfaces risks before it's too late.

  • Ensures the evidence gets generated on time and to the right quality standard.

The Asset Lead has veto authority on scientific decisions. The Program Lead has escalation authority when timelines or resources are at risk. Neither needs permission from the other, but they're in constant communication.

Stage-specific guidance:

• Pre-IND, single asset: Often one person (usually CSO), making accountability explicit.

• IND → Phase 1: You likely need both roles, as scientific judgment and execution accountability start to separate.

• Phase 2+, multiple assets: Definitely both, per asset. Your Head of R&D can’t own detailed execution across multiple programs.

Example: Mid-Stage Oncology

One company we worked with restructured IND prep around the model above, and instead of monthly cross-functional reviews where Biology presented to CMC, which then coordinated with Clinical, they put all three in a weekly working session with crystal clear decision rights.

The Results Were:

• Go/no-go cycles compressed 11 weeks → 5 weeks

• CMC caught a formulation stability issue 3 months early, prompted by Clinical asking, “If we're dosing in Q3, when do we need final formulation locked?”

• ~$400K saved by reallocating non-viable formulation to backup candidate to preserve budget and timeline.

Pivoting From Review Models to Accountability Models

Traditional review model:

• Biology completes work → presents to CMC in monthly meeting

• CMC raises concerns → schedules follow-up with Biology

• Clinical weighs in → asks for additional data

• Result was 6-8 weeks of calendar time for decisions that need 6-8 hours of actual work

Accountability model:

• Small team (4-6 people) owns the IND end-to-end

• Weekly 30-minute sessions, focused on "blockers" only

• Decisions made in the room when possible, escalated within 24-48 hours when not

• Results were decisions happening when the data was ready, not when the meeting schedule allowed

This requires:

• Clear decision rights. What can the team decide themselves? What needs exec approval? Board input? Know this clearly.

• Without this clarity, you’ll just created another meeting structure.

Where to Start

You don’t need to reorganize everything. Pick one near-term milestone—an IND submission in the next 6-9 months, a Phase 1 decision point, or a lead candidate selection.

1. Name your Asset Lead and Program Lead. Make ownership explicit.

2. Form a small cross-functional team around that milestone.

3. Run it for 8-10 weeks and evaluate:

   • Are decisions happening faster?

   • Are risks surfacing earlier?

If yes, you’ve validated the approach. Expand to your next milestone.
If no, the issue is usually one of three things:

• Decision rights aren’t actually clear

• Program Lead lacks real authority

• Team is still optimizing for their function instead of the asset