Evaluating the Competitive Landscape to Support a Best-in-class Strategy

Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support dose optimization and product positioning of a psoriasis drug. The sponsor needed to select the dose-range for Phase 2 studies of a novel drug for psoriasis using Phase 1b data. To borrow strength from published comparator data, MBMA was proposed for conducting a comparator analysis to enable model-based dose selection for Phase 2 studies. The results of the MBMA enabled the sponsor to proceed to Phase 2 trials with a dosing range that is more likely to support identifying the best dose to carry into Phase 3 trials.