Writing
Essays on AI-oncology, FDA strategy, and the discipline behind calibrated judgment.
Each piece below is written under the Citation-Required Output Contract — every claim of consequence is sourced, and the reasoning trail is shipped alongside the conclusion. The standard is the same one applied to client deliverables.
- 2026-09-01 · Regulatory note
What a First-in-Human Trial Is Actually For
An FIH oncology trial is worth exactly the decisions it lets three people resolve: the patient who said yes, the person spending the next development dollar, and the person spending the next investment dollar. Why the escalation algorithm is subordinate to the decision sequence; why dose optimization and the June 2026 QSP/MABEL draft moved the standard the installed base was designed against; and why the divergence between those chairs is the finding, not the noise.
- 2026-08-24 · Regulatory note
Model Validation, Process Validation, and the Decision That Is Not Yours to Make
Process validation asks whether a model improves a consequential decision — which holds while the decision is yours. At the regulatory interface it isn't: the agency decides whether the evidence supports the claim. The same model output can occupy four regulatory positions whose evidentiary burdens differ by more than an order of magnitude, and a program can slide between them without anyone deciding it should.
- 2026-08-06 · Regulatory note
What an Oncology Pre-IND Meeting Actually Decides — and How to Prepare for Useful FDA Feedback
The PDUFA VII sequence from readiness to Request for Clarification; why the meeting package does most of the substantive work; how to spend a ten-question ceiling; what the division assesses, in a common core plus conditional oncology modules; and why pre-IND advice is not permission to dose patients.
- 2026-08-05 · Engagement note
Why and When Should an AI-Driven Biotech Hire a Fractional CMO?
The gap a fractional CMO exists to close for an AI-driven biotech, the signals that say hire one now, the honest cases where it is the wrong call, and the AI-platform variant. What the role is — and the three things it is not.
- 2026-08-02 · Methodology case study
What a Governed Multi-Model Workflow Caught in Its Own Oncology Analysis
A bounded case study of role separation, frozen evidence, adversarial cross-family verification, deterministic controls, and human gates — including what one uncontrolled pilot can and cannot establish.
- 2026-05-12 · Thesis
Three Ways AI-Oncology Companies Will Fail at the FDA — and the Clinical Expertise Gap That Causes It
Within twelve to eighteen months, a meaningful share of today's well-funded AI-oncology companies will hit the FDA wall. Three failure modes — the endpoint that never was a drug, the patient who was never going to enroll, the black box that cannot be audited — all trace to the same missing input: calibration. (Also on LinkedIn.)
- 2026-05-20 · Follow-up
How I Would Know If I'm Wrong — Six Conditions for Falsifying the Three Ways Thesis
The six conditions under which the Three Ways thesis would be wrong — volume, distribution, causation, closure, timing, and calibrated-departure traction. Each tested against a specific part of the thesis. A calendar-anchored commitment to publish two post-mortems — at twelve and twenty-four months — whether the thesis holds or fails. (Also on LinkedIn.)
- 2026-05-12 · Engagement note
What the First 90 Days Look Like — Biotech-Shaped AI-Oncology Companies
The canonical four-phase, twelve-week operating arc for biotech-shaped AI-oncology companies — those running their own programs toward an IND. Each phase produces one specific artifact and retires one specific decision. The arc is built on an expansive-then-decisive discipline inside Phase 2 to guard against premature lock-in.
- 2026-05-12 · Engagement note
What the First 90 Days Look Like — AI-Platform Companies Selling Into Pharma
The parallel arc for AI-platform companies whose commercial trajectory depends on partners successfully defending the platform's role to the FDA. The agency-facing work in the biotech variant becomes partner-facing work: Platform Validation Package, Partner Q&A Library, Reasoned-Departure Support.
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