About — 5010 AI
About 5010 AI

Built by scientists.
Powered by intelligence.

We are a team of drug development professionals who spent careers navigating fragmented oncology data — and decided to fix it. Nexus is what we always wished existed.

Our mission

"To give every oncology team — regardless of size — the same quality of regulatory intelligence that only the largest pharma organisations could previously access."

25yr
FDA Record
800+
Approvals
4
AI Tools
Why we built this

The problem
we lived ourselves.

Every piece of this platform was shaped by a real frustration we experienced working in drug development.

The data existed. The access didn't.

Twenty-five years of FDA oncology approvals are public. But finding the right precedent — the right indication, pathway, endpoint, benefit-risk profile — meant hours of PDF hunting across multiple sites, with no guarantee you'd found everything relevant. We structured that record so you don't have to.

Landscape work was too slow.

Before a program enters the clinic, teams need to understand the competitive landscape, the regulatory precedent, where the white space is. That work took days of manual research and expensive consultants. We built an AI that does it in minutes — synthesising FDA, EMA, live trial data, and literature into a structured briefing with full source attribution.

Smaller teams deserved better tools.

Biotech startups and mid-size sponsors make the same regulatory decisions as large pharma — but without the same infrastructure. We built Nexus to level that playing field. The intelligence that powers billion-dollar programs, accessible to every oncology team.

AI needed to be trustworthy.

Generic AI hallucinates on regulatory questions. We built Nexus on grounded, source-attributed data — every claim links back to an approval document, guidance, trial record, or peer-reviewed paper. Your team can verify before they act.

What sets us apart

Domain-deep.
Not generic AI.

There are many AI tools. There is one platform purpose-built for oncology regulatory intelligence — trained on the data that matters, structured for the decisions drug development teams actually face.

🧬

Oncology-specific by design

Not a general-purpose chatbot applied to pharma. Every data source, every AI prompt, every output format was built for oncology regulatory work specifically.

📎

Source-attributed, always

Every claim Nexus makes links to the source — the approval document, the guidance, the trial registration, the PubMed paper. No black-box outputs your team can't verify.

Live data, not static snapshots

ClinicalTrials.gov, PubMed, and regulatory news are fetched in real time. Your landscape reports reflect what's happening now, not what was curated six months ago.

🌍

US and EU, side by side

FDA and EMA approval precedents are integrated and comparable. Regulatory divergence between regions is surfaced automatically — no separate research required.

🔭

Opus-powered depth

Landscape Intelligence runs on Claude Opus — Anthropic's most capable reasoning model — for deep synthesis across large, complex document sets. The quality shows.

🏗️

Built by people who've done the job

Our team has real-world experience across oncology, neuroscience, virology, and rare diseases in biotech and pharma. This platform reflects that institutional knowledge.

The platform

Five tools. One intelligence layer.

Nexus combines self-guided analytics with AI-powered tools — all grounded in the same curated oncology dataset.

📊
Approval Analytics
Self-guided dashboards across 800+ FDA approvals
Regulatory Signal
AI search and Q&A across FDA, EMA & ICH guidance
📡
Oncology Pulse
Real-time approvals, guidance & regulatory news
🌐
Landscape Intelligence
Deep-dive reports — white space, pipeline, strategy
📋
Label Intelligence
Ask anything about any FDA-approved oncology drug
NEXUS · LANDSCAPE INTELLIGENCE
FDA
EMA
ClinicalTrials.gov
PubMed
BETA
FDA Approvals · NSCLC · 2015–2024
Approval Trend
Landscape Intelligence · White Space
Pipeline Opportunity

3L+ EGFR-mutant NSCLC shows limited approved options post-osimertinib resistance. Live trial data identifies 7 active studies targeting this gap.

Sources · All cited
Data Provenance
FDA NDA 213246
EMA CHMP/2024
NCT04837209
PMID 38291847
ICH E8(R1)
+14 more
Get started

See what Nexus can do
for your team.

We're accepting a limited number of early access partners ahead of our full launch. Book a walkthrough and we'll show you what's inside — with your indication, your questions, your use case.

Contact us

Ready to learn more about 5010AI? We’d love to connect with you.