As the organization grows, the questions change.
The science worked well enough to get here. Now every program has an advocate, none has been formally stopped, and the pivotal study is the largest commitment the company has ever made. What used to be settled in a hallway needs a decision system, because the board has started asking why the sequencing looks the way it does.
The study the agency would endorse and the study the budget allows are not always the same. Finding that gap before the End-of-Phase 2 meeting, while the plan can still change, is worth far more than discovering it in the meeting itself.
A stage-gate architecture makes the trade-off explicit, so the choice rests on evidence and holds up with the board.
A team that ran three sites well is not automatically a team that can run a hundred across a dozen countries.
Knowing in advance whether a six-month delay is absorbable keeps the company’s options open.
By making the trade-off explicit. A stage-gate architecture sets out what each program needs to show, when, and at what cost, so the choice rests on evidence and holds up with the board. I help build that system and take the first decision through it.
Five questions decide it together: what the next data set will change about the program’s value, which path reaches patients sooner, what each option costs and returns, who should carry the regulatory path, and what each choice asks of the organization. I work through all five together.
When the study the agency would endorse, the budget, the manufacturing and supply plan and the operating model line up. I review each against the others before the End-of-Phase 2 meeting, while the plan can still change.
A finished brief is not needed. I read every message myself and reply with the two questions I would ask first. If I am not the right person, I will tell you who is.
Roberta Duncan, Founder and Principal