Better Than a Blank Page

The facts behind The Blank Page Is the Expensive Part: a real engagement, and what the demonstration actually produced.

What happened

A clinical-stage biotech had a wall coming: a stack of INDs and BLAs to file that ran well past what the regulatory writing team could physically reach in the time it had. The executive team wanted regulatory to trial AI for first drafts. The team said no, and held that no for twelve months, because it owns some of the highest-stakes documents in the company and was being asked to trust a new tool with exactly the work it is most accountable for.

The stall broke when a member of executive leadership stepped in and mandated a trial. The company had signed a six-figure vendor trial; alongside it, we ran a head to head. Over three days in a room, working with the company’s standard, already-paid-for tools, we drafted real first-draft sections of an upcoming IND, not a demo document.

What it produced

Two results. The drafts made with standard tools were far better than what the six-figure paid trial produced, so the vendor check was never the right first move. And the drafts landed at roughly 60 to 75 percent of a usable first draft, which was enough for several members of the writing team, watching a draft of their own work appear, to be dumbfounded. After twelve months of argument, the aha arrived in an afternoon, and the momentum that followed was large.

Precisely what it was: no AI-generated text went to the FDA. The first drafts were framing and a running start on structure. The team did the decisive work, the sourcing, argument, precision, and review, and the author of record was human throughout. Every section went through the standard writing and quality process.

The conditions that made it work

• Permission spent to force the trial. Without an executive using real capital to end the stall, the wall just gets closer. A demonstration nobody will authorize converts no one.
• A real head to head before the check. The needed capability was already inside tools the company owned. Test your own baseline before signing a paid trial.
• The draft is a start, not a submission. In regulated work, treating a 60-to-75-percent draft as finished turns a good tool into a liability. What the full review must include is a question for your own quality and regulatory function.

The argument for why a demonstration beats a year of no is in The Blank Page Is the Expensive Part.

How this was measured. The 60-to-75-percent figure and the comparison to the vendor trial are the participating writers’ qualitative, in-the-room judgment, not a blinded or standardized score. Treat it as a directional firsthand operator account from a single organization, not a controlled study.

Cheers,
-Titus