Case Studies
Respiratory Programs
Anti-IL5 Biologic
Challenge
Demonstrating exacerbation reduction benefit against injection site reactions and potential immunogenicity in long-term use
ArcaScience Approach
Integrated 3 pivotal trials and 4 years of post-marketing data across 8,500 patients with eosinophil-stratified analysis
Results
- ✓Eosinophil threshold-based benefit quantification
- ✓87% accuracy in hypersensitivity signal detection
- ✓Automated annual PSUR generation
Triple Combination Inhaler
Challenge
Quantifying pneumonia risk with ICS component against exacerbation and mortality benefits of triple therapy
ArcaScience Approach
Comparative BRA across dual and triple inhaler combinations integrating pneumonia, MACE, and exacerbation endpoints
Results
- ✓Pneumonia risk contextualized against mortality benefit
- ✓Cross-comparator BRA across 6 inhaler products
- ✓71% reduction in BRA document preparation time
CFTR Modulator Combination
Challenge
Long-term safety monitoring for hepatotoxicity and cataracts in a young patient population requiring lifelong therapy
ArcaScience Approach
Pediatric-specific safety modeling with liver enzyme monitoring integration and ophthalmologic event tracking
Results
- ✓Automated liver safety signal detection
- ✓Age-stratified benefit-risk profiles
- ✓Registry-integrated post-marketing surveillance framework
Aggregate Outcomes
Results Across Respiratory Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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