The reasoning layer pre-IND biotech teams can’t afford to hire.
A structured workspace for interpreting FDA guidance and precedent against a specific product profile. Sourced and auditable by construction.
A prostate cancer drug. Do we need female-animal tox studies?
The answer lives in conditional FDA language and scattered precedent, not in a spreadsheet or a generic model.
- D+0RA lead hits conditional FDA language in ICH S6(R1). No clear answer.
- D+2Digs through PDFs. Finds a competitor label but can’t access the full review document.
- D+4Calls a consultant at $300–500/hr. Gets “here are the considerations,” not a direct answer.
- D+7Decision delayed. Study planning stalls. Timeline slips.
- 00:01Enters product profile: small-molecule, prostate cancer, male-only, pre-IND.
- 00:03Workspace surfaces Pluvicto and Xtandi as precedent with male-only tox packages.
- 00:04ICH S6(R1) and ICH S9 clauses surfaced with plain-English applicability conditions.
- 00:05Auditable interpretation. Sourced reasoning chain attached. Bring it to pre-IND.
“90% of what’s done is grey zone.”
The structure is the product.
FDA guidance, ICH guidelines, and approval packages are public. The differentiator is how that data is curated and applied.
Structured intake
Captures modality, indication, population, and stage before any model touches the question. Routes to the right conditional logic.
Curated reasoning logic
Expert-validated decision paths. Which ICH clauses are conditional, which comparators apply to which profiles, what FDA has historically accepted.
Precedent surfacing
Comparable approvals matched by product profile. Tied to the actual FDA review documents, not keyword search.
Auditability by construction
Sources tied to the reasoning path structurally. Every step carries its citation with it.
A generic model still doesn't know which ICH clauses are conditional.
Enterprise subscriptions and local models solve data privacy. They do not solve the knowledge problem.
Too frequent for a consultant. Too consequential for a general model.
Founder-scientist or sole RA/CMC lead at a first-IND US biotech.
The person who is simultaneously the scientist, the strategist, and the regulatory lead, patching the gap with Google searches, scattered PDFs, and expensive consultant calls.
Working on your first IND? We’re talking to 15 teams this sprint.
We have a learning agenda, not a growth agenda. Honest product feedback is more useful than a sales pitch.
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