MyeLink Platform

The AI Operating System
for Pharmaceutical R&D

From scientific question to IND-ready output.
Autonomously.

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The Bottleneck

Drug development is slow because knowledge synthesis doesn't scale.

R&D teams spend the majority of their time aggregating literature, reconciling findings, and drafting documents — not making decisions.

$0
Median cost to bring a novel drug to market approval Wouters et al., JAMA 2020
0
To complete IND-enabling safety studies for a novel small molecule FDA / industry consensus
0
Of drugs entering Phase 1 clinical trials fail before reaching approval FDA data / DiMasi et al.

Multi-Agent Orchestration

Not a chatbot.
Not a copilot.
An autonomous R&D team.

MyeLink deploys a network of specialized AI scientists — each with deep domain expertise — that research, debate, synthesize, and produce outputs continuously. When a finding surfaces in pharmacology, the regulatory strategist re-evaluates the IND pathway in real time.

  • Continuous autonomous research cycles, 24/7
  • Cross-domain debate before any output is issued
  • Escalation to human decision-makers when needed
  • Every output traceable to its evidence chain

Real Outputs

From the engine. Not a demo.

Every output type below has been produced autonomously inside OrthoTreat's own IND pipeline.

Regulatory Brief
PMOA Classification: Drug-Device Combination Under 21 CFR Part 3
IND-ready jurisdictional argument produced autonomously from literature and regulatory precedent. Submitted to FDA review process.
IND-enabling · 12 pages
Genotoxicity Waiver
Lovastatin Class Waiver Justification
ICH-aligned waiver argument grounded in published safety data. Reduces costly genotoxicity study requirements.
Safety package · 8 pages
Scientific Analysis
Endogenous vs Exogenous BMP-2: Safety-Efficacy Paradigm
Mechanism deep-dive positioning ModulX against Infuse (rhBMP-2). Investor and advisor-ready with full evidence chain.
Track A · 6 min read
IND Simulation
Phase 1 IND Test Bench — 6-Drug Series
Full IND readiness simulations across 6 drug candidates. Surfaces gaps before CRO spend is committed.
Validated · 479 tests
CRO Protocol
OT-RAT-001 In Vivo Study Protocol
Partner-ready study protocol drafted to GLP standards. Directly used in the CRO tender process within 48 hours of output.
GLP-aligned · CRO-ready
Competitive Context
§21 Competitive Landscape & Fast Track Precedent
Market positioning, competitor pipeline mapping, and Fast Track designation precedent identification for bone regeneration.
BD-ready · Regulatory context

The Platform

Your pipeline. Your agents. Your outputs.

MyeLink is available as a licensed SaaS platform. Configure the agent network for your therapeutic area, your regulatory pathway, your stage of development.

Deploy

Onboard in days, not months. MyeLink connects to your existing knowledge base — literature, internal documents, regulatory filings — and is operational immediately.

  • No infrastructure to manage
  • Secure isolated tenant environment
  • Existing document ingestion

Scale

Run multiple programs in parallel. MyeLink operates 24/7 — while your team focuses on decisions, the engine handles synthesis, monitoring, and drafting.

  • Parallel pipeline coverage
  • Continuous literature monitoring
  • Audit-ready output provenance

Early Access

Ready to deploy
your R&D engine?

MyeLink is in selective early access. We work closely with founding partners to configure the platform for their specific pipeline.

sahar@orthotreat.io

OrthoTreat Ltd. · Israel