Drug-Disease-Trial Modeling and Simulation
Pharsight has world-class expertise building, integrating and applying drug-disease-trial models to optimize clinical development programs with respect to therapeutic potential, R&D productivity and commercial value. On more than 100 client engagements per year, we use model-based approaches to produce quantified insights and predictions for development decisions at every point along the regulatory timeline.
- Population PK/PD Modeling and Simulation: Knowledge of PK/PD is fundamental for dose-selection and can provide justification for bridging clinical data between populations, (e.g., adults to pediatrics), indications, or regions. Increased understanding of population variability in response supports fewer failed studies and a more efficient development path.
- Clinical Trial Simulation: Conduct computerized virtual clinical trials, test alternative designs and "what-if" scenarios (e.g., doses, arms, inclusion/exclusion criteria) before embarking on costly and time-consuming trials. The benefits of using clinical trial simulation are faster time-to-market, fewer failed studies, and more effective use of clinical study enrollees.
- Literature-Based Approaches for Competitive Product Positioning: Chart the treatment landscape for a class of competitive compounds, differentiate your compound, and understand likelihood of success per strategy. Benefits include clarified Phase 2-3 "go/no-go” decisions, support for in-licensing, optimal program/trial design strategies, and selection of a competitive dose earlier and with greater confidence.
Pharmacometrics is the science of quantifying disease, drug and trial characteristics with the goal to influence drug development, regulatory and therapeutic decisions. (Graphic provided courtesy of Dr. Joga Gobburu, OCP/FDA)*
*Gobburu JV. "End of Phase 2A Meetings with the FDA: Past and Future." AAPS eLearning Webinar Series; July 15, 2010.