CounterMeasure Studio connects the Axiom Quantum AI platform to the pharmaceutical and biotech countermeasure development pipeline — literature mapping, variant-trend dashboards, clinical-trial matching, FDA submission document control, manufacturing readiness scoring, and adverse-event signal routing. Built for BARDA contractors, vaccine developers, diagnostic companies, and academic medical centers.
Capabilities
- Literature mapping — AI-curated corpus of virology, immunology, and outbreak research
- Variant trend dashboard — genomic surveillance data summarized for non-bioinformaticians
- Clinical trial matching — patient cohort and site identification for countermeasure trials
- FDA submission document control — 21 CFR Part 312, 510(k), EUA workflow management
- Manufacturing readiness scoring — supply chain, capacity, and tech-transfer gaps
- Cold-chain modeling — distribution logistics for temperature-sensitive products
- Batch quality analytics — manufacturing process control and CPV trending
- Adverse-event signal routing — FAERS integration and post-market surveillance
Target Users
- BARDA advanced development contractors
- Vaccine and therapeutic developers — IND-stage to approval
- Diagnostic assay companies — EUA and 510(k) submissions
- Academic medical centers with countermeasure research programs
- Hospital pharmacy and P&T committees — formulary countermeasure planning
- State and federal public health agencies — medical countermeasure strategy
Regulatory Foundation
- BARDA mission alignment — CBRN, pandemic influenza, emerging infectious disease
- FDA guidance for drug and biological products containing nanomaterials
- ICH E6 GCP and ICH Q10 pharmaceutical quality system alignment
- EUA criteria and expedited review pathway documentation support
- HIPAA-compliant adverse-event data handling
Learn More About CounterMeasure Studio
Contact the PandemiCure team to discuss pilot programs, integration with your existing systems, or investment opportunities.