Case Studies
Neurology Programs
Anti-Amyloid Monoclonal Antibody
Challenge
Balancing modest cognitive benefit against ARIA risk in a large elderly population with limited treatment alternatives
ArcaScience Approach
Integrated Phase 3 trial data with ARIA MRI monitoring results across 3,500 patients using specialized ARIA classification models
Results
- ✓Quantified ARIA risk by ApoE genotype
- ✓82% accuracy in ARIA severity prediction
- ✓BRA documentation reduced from 16 weeks to 4 weeks
Gene Therapy Vector
Challenge
Assessing transformative benefit against hepatotoxicity and thrombotic microangiopathy risks in pediatric patients
ArcaScience Approach
Built pediatric-specific BRA model integrating motor milestone gains against acute safety events from clinical and post-marketing data
Results
- ✓Validated benefit-risk framework accepted by FDA and EMA
- ✓Automated PSUR generation for 6-month reporting
- ✓91% completeness in adverse event capture
CGRP Monoclonal Antibody
Challenge
Demonstrating favorable long-term safety profile for a chronic preventive therapy against existing standard of care
ArcaScience Approach
Comparative BRA integrating cardiovascular safety signals, immunogenicity data, and patient-reported outcomes across 5 clinical trials
Results
- ✓Comprehensive comparator safety analysis across 4 CGRP classes
- ✓Automated signal detection for cardiovascular endpoints
- ✓68% reduction in regulatory query response time
Aggregate Outcomes
Results Across Neurology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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