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Modeling & Simulation for Competitive Product Positioning

Successfully differentiating your compound in development from marketed competitors is critical to commercial success. Pharsight® provides strategies for differentiating between your compound and its competitors, and an associated likelihood of success per strategy. Our model-based approach combines:

  • Modeling of New Treatment: Quantitative drug-disease models integrate all the relevant pre-clinical and clinical PK/PD data on a new treatment to describe the important efficacy, safety and tolerability endpoints.
  • Competitor Modeling: Publicly available data and information from the scientific literature are modeled to derive dose-reponse curves for a class of competitive compounds. Proprietary data on the new treatment is combined with the public-source database to jointly model the attributes of the new drug and its competitors.
  • Clinical Utility Modeling: A Clinical Utility Index (CUI®) provides a single metric for multiple dimensions of benefit and risk, and captures expert opinion on the therapeutic importance of a treatment’s product characteristics. Combined with drug-disease models, the CUI provides an estimate of net patient benefit relative to competing treatments.
  • Software to Communicate Model-Based Results: Drug Model Explorer® is Pharsight's web-based visualization tool to explore model-based product profiles. Development teams use DMX to compare modeling and simulation results for different endpoints, treatment strategies, patient populations, and competing products.

Pharsight's clients use model-based competitive product analysis to make ?go/no-go? decisions, support in-licensing strategies, define optimal development program/trial design strategies, and select a competitive dose earlier and with greater confidence.