Case Studies
Infectious Disease Programs
Long-Acting Injectable ART
Challenge
Establishing BRA for monthly/bimonthly injectable regimen versus daily oral ART, addressing injection site reactions and viral resistance risk
ArcaScience Approach
Comparative BRA integrating adherence-adjusted efficacy, ISR characterization, and virologic failure risk analysis across 4 pivotal trials
Results
- ✓Adherence-adjusted benefit quantification
- ✓ISR tolerability pattern characterized
- ✓77% reduction in resistance BRA analysis time
Pan-Genotypic DAA Combination
Challenge
Post-marketing safety monitoring for hepatitis B reactivation and hepatocellular carcinoma signals after viral cure
ArcaScience Approach
Long-term post-SVR safety surveillance integrating HBV reactivation monitoring and HCC incidence analysis from 180,000 treated patients
Results
- ✓HBV reactivation risk quantified and contextualized
- ✓HCC post-SVR surveillance framework automated
- ✓Annual PSUR generation reduced to 2 weeks
mRNA Vaccine Platform
Challenge
Rapid benefit-risk assessment under EUA timeline with limited long-term safety data and evolving variant efficacy
ArcaScience Approach
Dynamic BRA framework with rolling safety data integration, variant-specific efficacy modeling, and population-stratified risk assessment
Results
- ✓EUA-compliant BRA documentation in 72 hours
- ✓Myocarditis signal detected and characterized within 6 weeks
- ✓Dynamic risk-benefit recalculation as data accumulated
Aggregate Outcomes
Results Across Infectious Disease Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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