Katogen Engine™Strategic biopharma intelligence - Executive Snapshots, Pipeline Deep-Dives, rNPV models, Risks & Catalysts, and full Investment Theses - delivered in minutes—not weeks.

The only operator-encoded AI platform that turns raw asset, company, disease-area, or competitive data into complete, board-ready strategic reports. Built on 35+ years of real-world execution, 17 closed acquisitions, and $4B+ in capital raised.

No junior analysts. No six-figure consulting invoice. Just the exact intelligence your board, BD team, or next investor actually needs—with email when deep reports finish. Built on 101 official sources (primary government APIs, registries, and literature endpoints).

Free sample reports

Three full PDFs — illustrative only, not personalized advice. Opens in a new tab.

Katogen Engine™ is the Intelligence pillar of The Katogen Engine — our operator-encoded AI layer for board-ready strategic reports. Strategy and Operations extend the same model when you need judgment and execution beyond the report.

Most strategic reports take weeks and cost tens of thousands.

Katogen Engine delivers professional-caliber analysis in minutes—not weeks—because biopharma decisions rarely wait.

Process

How it works

  1. 1

    Select your report type or describe your asset, deal, or scenario

    Anchor the run the way a strategic team would in week one - company, asset, disease area, or competitive frame.

  2. 2

    Operator-augmented AI synthesizes public and sponsor data

    Katogen Engine encodes decades of execution judgment - not a generic outline - into structured, board-ready intelligence.

  3. 3

    Download a polished, dataroom-ready PDF

    Primary-source citations, commercial-significance bullets, and explicit Decision / Reversibility sections.

Differentiation

Why Engine is different

Seven core report types (plus custom queries)

From Executive Snapshot through full Investment Thesis - each module is tuned for how boards and BD teams consume strategy.

  • Executive Snapshot - High-level landscape, market sizing, strategic implications.
  • Pipeline Deep-Dive - Competitive matrix and positioning analysis.
  • rNPV & Valuation - Quantitative scenarios, sensitivity tables, and valuation models.
  • Risks & Catalysts - Scenario analysis, key risks, and upcoming milestones.
  • Operator Precedents - Real-world playbooks and historical execution examples.
  • Strategic Implications - BD/M&A options, payer landscape, and long-term value drivers.
  • Investment Thesis - Full rationale, value drivers, risks, and valuation scenarios.
  • Operator scar tissue baked in at every layer

    Built on 35+ years of real-world execution, 17 closed acquisitions, and $4B+ in capital raised - encoded where generic models skip judgment.

  • Dataroom-ready output every time

    Polished narrative, citations, and sections your team can forward without rewriting.

  • Seamless hand-off to Katogen Sentinel

    Turn static Engine intelligence into persistent Watches and operator-vetted alerts.

Official sources first

Katogen source stack

Katogen Engine assembles a timestamped evidence pack for every run: SEC EDGAR (filings + XBRL), ClinicalTrials.gov, excerpts from Katogen’s primary-source library, plus PubMed / Europe PMC and bounded web recency where needed. If the pack cannot support the module, Engine refuses to generate.

101 official sources (76 on a refresh schedule · 24 live on every run · 1 biotech issuer filing index) · see full source catalog

FDA & US drugs

CRLs, Drugs@FDA, labels, expedited designations, AdCom, inspections, safety comms, and press RSS.

21 sources — show list
  • CDC ACIP — vaccine recommendations(CDC)
  • DailyMed / drug labeling (openFDA)(FDA)
  • DEA — controlled substance scheduling(DEA)
  • Drugs@FDA applications (openFDA)(FDA)
  • FAERS adverse events (bounded openFDA)(FDA)
  • FDA advisory committee calendar(FDA)
  • FDA AI / SaMD policy (CDRH)(FDA)
  • FDA CDRH — device guidance(FDA)
  • FDA complete response letters (openFDA)(FDA)
  • FDA drug safety communications(FDA)
  • FDA expedited designations (OOPD)(FDA)
  • FDA import refusals & alerts(FDA)
  • FDA inspections & 483s (openFDA enforcement)(FDA)
  • FDA Office of Combination Products(FDA)
  • FDA Oncology Center of Excellence(FDA)
  • FDA press releases (RSS)(FDA)
  • FDA quality & enforcement actions(FDA)
  • FDA Sentinel public RWE reports(FDA)
  • FDA-related litigation dockets (bounded)(FDA)
  • IND critical path operator framing(FDA)
  • OHRP — human subjects / Common Rule(OHRP)
Trials

ClinicalTrials.gov live API plus EU CTIS index excerpts.

2 sources — show list
SEC & capital markets

EDGAR filings, XBRL, proxies, full-text search, antitrust notices, halts, and EOD quotes.

10 sources — show list
  • End-of-day market quotes(Finnhub/Polygon)
  • Finnhub — end-of-day market quotes(Finnhub)
  • Healthcare antitrust / HSR (Federal Register)(FTC/DOJ)
  • NASDAQ trading halts(NASDAQ)
  • Polygon.io — end-of-day market quotes (US fallback)(Polygon)
  • SEC DEF 14A proxy statements(SEC)
  • SEC EDGAR filings index(SEC)
  • SEC EDGAR full-text search(SEC)
  • SEC primary document excerpts(SEC)
  • SEC XBRL company facts(SEC)
Payer & access

CMS coverage & IRA, ICER HTA, EU HTA bundle, AMA CPT, and WHO essential medicines.

9 sources — show list
  • AMA CPT / RUC coding policy(AMA)
  • CMS Medicare coverage (NCD/LCD)(CMS)
  • CMS Medicare drug affordability / IRA(CMS)
  • CMS Part D & Medicaid open data(CMS)
  • EU HTA guidance index (NICE, HAS, …)(EU)
  • HRSA 340B / OPA policy(HRSA)
  • ICER value assessments(ICER)
  • Medicare Part D payment policy(CMS)
  • WHO essential medicines list(WHO)
IP & exclusivity

Orange Book, Purple Book, USPTO bulk, PTAB, and EPO legal status.

6 sources — show list
  • EPO patent legal status / SPC context(EPO)
  • FDA Orange Book (small-molecule exclusivity)(FDA)
  • FDA Purple Book (biologics)(FDA)
  • USPTO patent bulk index(USPTO)
  • USPTO PTAB — proceedings portal(USPTO)
  • USPTO PTAB decisions(USPTO)
Global regulators & filings

EMA EPAR, EU safety, ex-US agency indices, SEDAR+, Companies House, and ESMA.

10 sources — show list
  • EMA EPAR summaries (English)(EMA)
  • EMA PRAC & MHRA drug safety updates(EMA/MHRA)
  • EMA quality guidelines (ICH-aligned)(EMA)
  • ESMA EU parent issuers(ESMA)
  • ICH harmonization guidelines(ICH)
  • MHRA — UK medicines regulator(MHRA)
  • PMDA, Health Canada, TGA, Swissmedic (English indices)
  • SEDAR+ Canada filings index(CSA)
  • UK Companies House(UK CH)
  • US BIS export control guidance(BIS)
Science & literature

PubMed and preprint ingest; live PubMed, Europe PMC, and preprints on Engine and BoardMemos runs.

2 sources — show list
  • bioRxiv / medRxiv preprints (ingest)
  • PubMed pivotal publications (ingest)(NIH)
Policy & federal register

Federal Register, Regulations.gov, EUR-Lex pharma package, and thematic EPA surfaces.

6 sources — show list
  • EPA facility / site search (supply themes)(EPA)
  • EUR-Lex EU pharmaceutical legislation(EU)
  • Federal Register documents API(US GPO)
  • FTC — health privacy & data security cases(FTC)
  • HHS HIPAA & health privacy policy(HHS)
  • Regulations.gov dockets API(US GPO)

Pricing

Simple tiers

Free

3 reports per month

Full report quality across core types - ideal to prove fit before upgrading.

Continue with email in Engine

Pro - $49/month

Unlimited reports

For teams that live in strategic drafts. Pro includes compare-last-run on tickers and one-click Sentinel watches. Pair with BoardMemos™ for board-grade depth on the same asset.

Open Engine to upgrade

Social proof

What leaders say

“The investment thesis report is IB analyst quality.”
- Biotech COO
“Finally, an AI tool that actually thinks like a seasoned operator.”
- Biotech Founder

Next step

Ready for operator-grade strategic insight in minutes?