Case Studies
Hematology Programs
Anti-CD19 CAR-T
Challenge
Managing severe CRS and ICANS risk against durable complete response benefit in patients who failed 2+ prior lines
ArcaScience Approach
Integrated CRS/ICANS grading data from 750 patients with response durability modeling and healthcare utilization analysis
Results
- ✓CRS severity prediction model (AUC 0.89)
- ✓ICANS risk factor identification automated
- ✓REMS documentation generated in 2 weeks
BCL-2 Inhibitor
Challenge
Tumor lysis syndrome risk management during dose ramp-up balanced against deep MRD-negative response rates
ArcaScience Approach
TLS risk-stratified BRA with real-world dose ramp-up safety data from 5,200 patients across 3 indications
Results
- ✓Automated TLS risk stratification algorithm
- ✓MRD-negativity benefit quantification
- ✓82% reduction in safety narrative preparation
Gene Therapy (Lentiviral)
Challenge
Balancing curative potential against myeloablative conditioning risks and unknown long-term insertional mutagenesis hazard
ArcaScience Approach
Long-term benefit projection integrating vaso-occlusive crisis reduction, hemoglobin levels, and genomic insertion site monitoring
Results
- ✓15-year benefit-risk projection model
- ✓Insertional mutagenesis surveillance framework
- ✓Supported BLA and conditional MA submissions
Aggregate Outcomes
Results Across Hematology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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