Modeling Fast-Track Uncertainty in Oncology Projects

About four years ago, we started rethinking how to support better drug development decisions, especially when it comes to strategic pivot points in projects. A recent example of that thinking is being used in oncology projects approaching phase 2, where fast-track designation might be an option.

We've worked with several project teams on this. They often face tight timelines, competing programs, and a complex path to launch. A typical challenge is: What’s the best development strategy if a fast-track designation is a possibility but far from guaranteed?

To help, we’ve built a flexible, probabilistic model that captures multiple paths to launch, without needing to maintain two or more separate versions of a project.

🧩 The model follows a sequence of steps, illustrated in the process diagram:

Step 1: Run a first safety trial

Step 2: Make a go/no-go decision after phase 1

Step 3: Run a small first trial in phase 2 or 3

Step 4: Assess early data—if there’s no response, terminate. If the interim data is exceptional, aim for fast track

Step 5: The NDA will be based on either interim data or full pivotal trial data.

🏁 The launch timing will depend on whether the project gets fast-track status. If granted, the program moves to submission early, often years ahead of the traditional path. This is where dynamic modeling becomes essential. Launch timing affects commercial potential, order of entry, and ultimately value.

📈 Our sales model in this case adapts based on development outcomes. If a fast-track path results in an earlier launch, that affects downstream revenue. The model captures these relationships explicitly—sales as a function of development success and timing.

📊 The decision tree output shows the upsides & risks in one view. Each diamond is a decision, each branch is an outcome. Red dots show terminations, green triangles show launches. The tree tracks:

– Probability of reaching each decision point

– Expected date for that milestone

– eNPV at that point in time

– Probability of launch from that node

What stood out in one case was how a fast-track designation had the potential to double the project value. On the other hand, missing it dropped the value by 65%. That’s insight you can’t get from a flat timeline or a one-size-fits-all sales forecast.

🔍 For drug developers making decisions under uncertainty, this kind of structured modeling, paired with visual tools like the decision tree, is a game-changer. You can simulate different strategies, compare outcomes, and understand what’s at stake.

Curious to hear how others are modeling these kinds of decision dynamics.