Pharma & Biotech

Drug discovery memory
that compounds over time.

The cold-start problem in drug discovery isn’t inconvenient — it’s a $1.4B problem. Every AI session re-analyzes the same failed compounds, same targets, same assay data. CLEOS eliminates that waste. FDA’s 2025 draft guidance on AI in regulatory submissions explicitly requires audit trails and provenance for any AI-generated content in IND, NDA, or BLA filings.

$16.5B
Pharma AI market by 2034 at 27% CAGR
$1.4B
Average cost to bring a drug to market
$15B+
AI drug discovery partnership deals in 2025 alone
2025
FDA draft guidance requires AI provenance in submissions
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The Problem

In drug discovery, AI context loss doesn’t cost minutes. It costs years.

The $1.4B average drug development cost is driven partly by redundant work — re-analyzing known failures, re-reviewing established literature, re-briefing AI on campaign context that was captured and then lost. CLEOS solves the compounding inefficiency at its root.

$1.4B
Average cost to bring a drug to market — context waste is measurable
A significant portion of drug development cost comes from redundant work: re-screening known-inactive compounds, re-reviewing established literature, re-analyzing stable structural activity relationships. AI should eliminate this redundancy — but without persistent memory, every session starts from zero and re-pays this cost.
Deloitte Research Pipeline Analysis 2025
FDA
2025 draft guidance requires AI audit trails in IND, NDA, BLA filings
FDA’s 2025 draft guidance on AI in regulatory submissions explicitly requires audit trails and provenance for any AI-generated content included in IND, NDA, or BLA filings. Submissions containing AI-assisted analysis without provenance face rejection. This isn’t future policy — it’s the standard for submissions being reviewed right now.
FDA Draft Guidance on AI/ML in Regulatory Submissions 2025
27%
CAGR in pharma AI — the market is moving fast, governance is lagging
Pharma AI investment is growing at 27% CAGR, driven by $15B+ in partnership deals in 2025 alone. But AI governance in drug discovery is still largely ad hoc — creating mounting regulatory risk as FDA scrutiny of AI-assisted submissions intensifies and as multi-site trial coordination requires cross-system data isolation.
GlobalData Pharma AI Report 2025

The Solution

How CLEOS solves the drug discovery AI governance problem

Three capabilities that eliminate the context waste compounding drug development costs, satisfy FDA provenance requirements, and enable multi-site trial coordination.

1
Drug Discovery Session Continuity
Drug discovery campaigns span months to years — with AI-assisted hypothesis generation, compound screening, and SAR analysis spread across hundreds of sessions. Without persistent memory, every session re-ingests the full campaign context: known failures, active hypotheses, structural constraints, literature anchors. CLEOS captures the complete campaign context at the first session and injects only the relevant portions on subsequent sessions — eliminating cold-start waste while ensuring that failed compounds are never re-screened because the AI forgot they failed. The system compounds intelligence with every session: what failed in Month 1 informs Month 6 without requiring any researcher to re-brief the AI on known history.
Campaign ContinuityFailure MemorySAR Context
2
Regulatory Submission Provenance & FDA Compliance
Every AI-generated statement in a regulatory submission — efficacy summary, safety analysis, comparative effectiveness assessment — must be traceable to its source data and reasoning chain under FDA’s 2025 draft guidance. CLEOS captures the complete reasoning chain for every AI-generated clinical or scientific statement: what source data was accessed, what analytical framework was applied, what alternative conclusions were considered, and what human review was performed. This provenance documentation is generated automatically — not reconstructed manually before submission. For organizations submitting multiple INDs and NDAs per year, the time savings alone (typically 200-400 hours per submission for AI audit documentation) pay for CLEOS infrastructure many times over.
FDA 2025 Draft GuidanceIND / NDA ProvenanceAutomatic Documentation
3
Multi-Site Clinical Trial Coordination
Phase II and III clinical trials operate across dozens of sites — with AI agents supporting enrollment screening, adverse event analysis, protocol deviation monitoring, and interim efficacy analysis. CLEOS enables these agents to share relevant cross-site context (enrollment trends, AE signals, protocol clarifications) while maintaining strict site-level data isolation (no site’s patient data is accessible to agents serving other sites). For Safety Monitoring Board AI tools, CLEOS provides the full audit trail of every AI-assisted unblinded analysis — satisfying the oversight documentation requirements that trial integrity protocols mandate. For CROs managing multiple sponsor programs, CLEOS enforces sponsor-level data walls automatically.
Multi-Site IsolationSMB Audit TrailCRO Data Walls

Why the Math Works

Pharma ROI compounds across discovery efficiency, submission speed, and trial costs

The unit economics of drug development make even small efficiency gains worth tens of millions. CLEOS delivers large efficiency gains.

91%
AI compute reduction per discovery session
On a $85K/month AI infrastructure budget across a discovery organization, $924K/year in direct savings. At the scale of a major pharma company’s AI infrastructure, this translates to tens of millions annually.
$15B+
AI partnership deals in 2025 — governance is now table stakes
Every AI-pharma partnership signed in 2025 includes AI governance requirements. Organizations with production-proven governance infrastructure are winning deals; those building governance ad hoc are not.
27%
Market CAGR — early governance infrastructure is durable advantage
At 27% CAGR, organizations that establish AI governance infrastructure now will compound that advantage as AI capability and regulatory scrutiny both increase. First-mover advantage in AI governance is directly translatable to faster FDA clearance cycles.

Regulatory Alignment

Every pharma AI mandate CLEOS satisfies natively

FDA’s AI regulatory framework is developing rapidly. CLEOS is built to satisfy not just current requirements, but the trajectory of where FDA is heading.

FDA Draft Guidance — AI in Regulatory Submissions (2025)
Requires audit trails and provenance for AI-generated content in IND, NDA, and BLA filings. CLEOS generates complete provenance documentation for every AI-assisted analysis — automatically, not through manual reconstruction.
FDA · 2025 Draft
21 CFR Part 11 — Electronic Records
Requires audit trails, access controls, and electronic signature capability for regulated electronic records. CLEOS’s session logging satisfies Part 11 audit trail requirements natively for all AI-generated records in regulated workflows.
CFR · Active
ICH E6(R3) — Good Clinical Practice
Updated GCP guidelines require traceability and documentation for AI-assisted trial management decisions. CLEOS captures the full decision chain for every AI-assisted clinical trial action — enrollment decisions, protocol deviations, AE assessments — satisfying ICH E6(R3) documentation requirements.
ICH · Active
EU AI Act — High-Risk Medical AI Systems
AI systems used in medical device development and clinical decision support are classified as high-risk under the EU AI Act. Effective August 2026, these systems require audit trails, explainability, and human oversight documentation — all of which CLEOS provides natively.
EU · Effective 2026

Buyers

Who in pharma and biotech buys CLEOS

Pharma AI governance spans computational science, regulatory affairs, clinical operations, and data leadership.

VP Computational Biology
Owns AI infrastructure for drug discovery. CLEOS provides the persistent memory and campaign continuity that compounds discovery intelligence over time.
Head of AI Research
Accountable for AI performance and governance in research workflows. CLEOS provides the infrastructure that makes AI research governance automatic — not a separate compliance exercise.
Head of Regulatory Affairs
Responsible for FDA submission quality and approval strategy. CLEOS produces the AI provenance documentation that FDA’s 2025 draft guidance requires — automatically, for every submission.
Chief Data Officer
Manages data governance across discovery, clinical, and regulatory functions. CLEOS enforces data boundary compliance at the infrastructure level — satisfying ICH, Part 11, and GCP requirements across all AI workflows.

FDA is watching every AI submission.
CLEOS is ready.

See how CLEOS eliminates discovery context waste, generates FDA-ready provenance documentation, and enables multi-site trial coordination — all from one infrastructure layer.

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