Our Approach
Our model-based approach on your inflammation/ autoimmune program is customized to meet your specific development decisions, taking into account the richness of available information about your drug and its competitive environment.
Project deliverables might include:
- Dose-response modeling and decision analysis for dose optimization (e.g., leveraging available biomarker data in MS)
- Model-based meta-analysis to predict drug performance versus competitors (e.g., combining pre-clinical and public-source clinical evidence in RA)
- Clinical utility modeling to aid in key dose selection and development strategy decisions (e.g., quantifying key risk-benefit tradeofffs for AEs associated with immunosuppressants)
- Clinical development program design to support informed “go/no-go” decisions
- Trial design, simulation and analysis to maximize likelihood of success (e.g., including adaptive designs to accelerate learning)
- Post-approval program strategies (e.g., drug-disease modeling and trial design to support label expansion)