Case Studies
Immunology Programs
IL-23 Inhibitor
Challenge
Demonstrating superior benefit-risk versus IL-17 and TNF inhibitor classes across two indications with different risk profiles
ArcaScience Approach
Cross-indication comparative BRA integrating 14 clinical trials and real-world evidence from 22,000 patients across 3 biologic classes
Results
- ✓Quantified class-level safety differentiation
- ✓Automated NNT/NNH calculations across PASI/ACR endpoints
- ✓75% reduction in comparative BRA document preparation
Selective JAK1 Inhibitor
Challenge
Addressing FDA boxed warning concerns for MACE, VTE, malignancy, and serious infections in the post-ORAL Surveillance era
ArcaScience Approach
Deployed cardiovascular and malignancy signal detection models across clinical trial and post-marketing data with active comparator analysis
Results
- ✓Automated MACE/VTE monitoring aligned with FDA requirements
- ✓93% accuracy in serious infection signal classification
- ✓Quarterly safety update generation reduced from 6 weeks to 10 days
TNF Inhibitor Biosimilar
Challenge
Establishing comparable benefit-risk profile across 6 approved indications with limited clinical trial data per indication
ArcaScience Approach
Totality-of-evidence BRA framework integrating analytical, nonclinical, PK, and clinical data with immunogenicity comparability assessment
Results
- ✓Streamlined multi-indication BRA package
- ✓Immunogenicity comparability demonstrated across switching studies
- ✓Regulatory approval in EU, US, and Japan within 18 months
Aggregate Outcomes
Results Across Immunology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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