Briefing packages that anticipate the questions.
Asthra drafts Pre-IND and Advisory Committee briefing documents — assembling nonclinical, CMC, and clinical evidence into a benefit-risk narrative. Every position on an FDA question is backed by a claim you can trace to its source, so the package holds up under scrutiny.
What you bring to the draft.
Asthra assembles the package from the evidence your program has generated.
Nonclinical Summary
Pharmacology and toxicology — for the Pre-IND nonclinical section and the starting-dose justification.
Integrated Safety Database
Pooled adverse-event tables and exposure-adjusted rates for the integrated safety section.
Integrated Efficacy Analyses
Primary and secondary endpoints across trials — the basis for the efficacy narrative.
Prior Meeting Minutes
FDA feedback and prior interactions, so the package addresses what the agency already raised.
FDA Voting Questions
The questions the package must answer — each mapped to a position and its supporting evidence.
CMC Summary
Chemistry, manufacturing, and controls for the CMC overview section.
From the program evidence
to a briefing package.
Upload & classify
Drop your nonclinical summary, integrated safety and efficacy data, prior minutes, and voting questions into the project. Asthra classifies and indexes each.
Approve the plan
Asthra proposes the package structure — Pre-IND or AdCom — and maps each FDA question to the evidence that answers it. Approve once.
Generate the first draft
Asthra computes integrated analyses with auditable Python, drafts the benefit-risk narrative, and proposes positions on each voting question. Gaps flag where the evidence is thin.
Writer review in Word
Refine the benefit-risk argument, regenerate a pooled-safety table, or run an FDA reviewer persona over your positions in the task pane. Every change is logged.
Hand off for sign-off
The package ships with the audit ledger embedded — every position traces to the analysis and the source data behind it.
What changes for the regulatory team.
Manual briefing drafting
- −Integrated safety and efficacy assembled by hand across many study reports
- −Benefit-risk narrative synthesised from thousands of records under deadline
- −Positions on FDA questions argued without a clean evidence trail
- −Pooled tables rebuilt manually for each package
- −Consistency with prior FDA interactions tracked by memory
Briefing drafting with Asthra
- +Integrated analyses computed with deterministic, auditable Python
- +Benefit-risk narrative grounded in the cited evidence base
- +Each position mapped to the claims and sources that support it
- +Pooled tables generated from source data, reproducible
- +Prior interactions carried forward as structured state
Pilot Asthra
on a real briefing package.
30-day pilot. Bring one program. We'll match Asthra's briefing package against your existing process — section by section.