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.

• 2026-05-12 · 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. (Published on LinkedIn.)

• 2026-05-22 to 2026-05-26 · Follow-up Forthcoming

  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 commitment to revisit the list at twelve and twenty-four months and publish the post-mortem either way.

• 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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