The Front Door · Calibration Sprint
A short, senior-led engagement that tells you — with reasons — whether your AI-oncology program, platform claim, or regulatory story is calibrated enough to carry into a serious FDA-facing or board-facing conversation, and whether the right move is to fit established precedent or to propose a reasoned departure the evidence can defend.
The scarce input is not the AI. It is the senior clinical-regulatory operator who knows when the AI is wrong — and has thirty years of FDA interactions to prove it. The Sprint puts that judgment on your specific decision, on a two-week clock, for a fixed fee.
Why This Exists
The obvious failure is overclaiming. A program reaches the pre-IND or first-in-human stage carrying an endpoint the agency does not regard as a development endpoint, a trial design that cannot enroll its intended population, or a model whose provenance cannot be audited to regulatory standards. The story is ahead of the evidence.
The subtler — and often costlier — failure is premature conformity. A program forces itself into established precedent when the science, the mechanism, the biomarker, or the patient population may warrant a reasoned departure. Some of the most consequential oncology approvals — accelerated approvals on early response data, tumor-agnostic labels, novel surrogate endpoints validated under unmet need — came from sponsors who engaged the agency in territory the agency itself acknowledged was less well understood, and who built the evidentiary package that made the new path defensible.
The failure is not choosing one or the other — it is not knowing which case you are in, and not having the evidentiary package that would make the chosen path defensible. Both failures are failures of calibration between what the model or platform produces and what regulators have historically required — or would entertain. Most companies discover the misalignment late — inside a pre-IND meeting, or in front of a board — after capital and calendar time are already committed. The Calibration Sprint is designed to surface it before that.
The Question the Sprint Retires
Before we spend the capital and the calendar time — is our development story calibrated enough to survive the room it's about to enter? And are we forcing ourselves into precedent when the science warrants a reasoned departure — or proposing beyond precedent when the evidentiary package is not yet defensible?
You walk out knowing what is true, what is conditionally true, what is asserted but unsupported, and which of your next decisions carry the highest regulatory consequence — each with the reasoning trail, the strongest counterevidence, and the conditions under which the recommendation would change. And for the decisions where it matters, you walk out knowing which posture the evidence actually supports — fit the guidance, or propose a reasoned departure — and what it would take to make that choice defensible.
What the Sprint Delivers
01
A structured separation of what is known (cited, source-tiered), what is conditionally true (true if X, X named), and what is asserted but unsupported (named, with the gap) — plus which of the next 8–12 decisions carry the highest regulatory consequence, ranked. Each high-consequence decision carries a risk track, a reference class, the next best learning action, and a revisit trigger.
02
A senior synthesis of the regulatory, clinical, and competitive evidence bearing on the single most consequential open question. The brief states explicitly whether the right posture is to fit established guidance or to propose a reasoned departure, locates the agency-acknowledged territory of uncertainty a departure would occupy, and names the evidentiary package that would make it defensible enough to raise. Every claim of consequence is retrieved, source-tiered, and externally cited. Where the evidence does not support a recommendation, refusal is part of the output.
03
The current posture, the single largest open risk, the proposed next regulatory interaction, and the decision that must be made before it — readable in under two minutes, built to travel to investors and future hires.
04
A live pressure-test with JGN. This is where the adversarial senior-operator judgment shows up: your assumptions get argued against, not summarized back to you.
This is a Decision Brief, not a research report. A junior analyst or a cheaper AI tool can summarize papers. What you are buying is the calibrated judgment of a senior clinical-regulatory operator red-teaming your program's assumptions against what the agency will actually adjudicate.
Timeline · 10 Business Days
Day 0
Produces
Is the question answerable in a Sprint? Go / no-go, and scope.
Days 1–3
Produces
Evidence and context scan; read-in to the asset or platform. A working surface.
Days 4–7
Produces
Calibration analysis; adversarial review; source-tiering. The Calibration Map.
Days 8–10
Produces
The Evidence Brief and Board One-Pager; the readout call.
Delivered asynchronously by design (Madrid / CET), with the readout scheduled in the East- or West-Coast overlap window. The written artifacts travel across time zones without a meeting to explain them.
Who This Is For
You are a fit if the decision in front of you is real and load-bearing — endpoint strategy, trial design, indication choice, or "can our partner defend this to a CDER reviewer?" — and you want senior judgment on it now, without first committing to a multi-quarter relationship.
Biotech-shaped — the work happens at the agency–sponsor interface: target, indication, endpoint, population, trial-design and regulatory friction on your program. Platform-shaped — the work happens at the partner–platform interface: what regulatory-readiness support the platform can credibly offer partners, what must remain partner-owned, and which commercial claims will not survive a partner's regulatory team.
The Sprint converts into a longer arc where warranted — see the first-90-days notes for the biotech-shaped and platform-shaped variants.
Inputs Required
What the Sprint Is Not
How It Connects
You can take the Calibration Map, Evidence Brief, and Board One-Pager and walk. Where it warrants, the Sprint is also the natural first rung:
Calibration Sprint → 90-day operating arc → Fractional CMO, Board or Scientific Advisor, or Co-founder.
If the Sprint surfaces that the real need is the next 8–12 decisions across a full pre-IND arc, the conversion path is explicit — and, where warranted, a portion of the Sprint fee may be credited toward a subsequent 90-day engagement by agreement. If it surfaces that the program needs less than you thought, the Sprint says so. Refusal is part of the output.
See the full engagement structures and the operating standard behind every deliverable.
Start a Conversation
The fit call tests one thing: whether a decision you are facing is sharp enough to retire in a two-week Sprint. If it is, you get a scope and a fixed fee. If it is not, you will hear that too.
Prefer email? jgn@oncadios.com