Rosa Webinar Series

Webinar Program

Do you need a life scientist for QSP modeling?

Katherine Kudrycki, PhD
Principal Scientist at Rosa & Co. LLC

While QSP models are defined as comprehensive models of biological mechanisms, the inclusion and role of life scientists and disease area experts in model development are often omitted or overlooked. This webinar addresses how including dedicated life scientists on the QSP modeling team can improve model quality and enhance research results.

QSP modeling begins with scoping of the biological system and progresses to include equations and parameters consistent with physical and biochemical principles. Each decision in the development and qualification of QSP models requires scientific judgment. Life scientists with expertise and experience in the appropriate therapeutic area or biological field can provide essential input for the design of the model. Life scientists apply expert judgment to make scope decisions, assess data, inform assumptions where knowledge gaps exist and provide a biologically relevant interpretation of model simulation results. Without dedicated expert life scientist input, a team may run the risk of building models that "work" but are not fit for purpose or are not biologically sound. For example, a model may show good agreement with data on previously measured outcomes but have unrealistic parameter values or qualitative behaviors that are clear to a biologist.

Life scientists' interpretation of simulation results can improve the likelihood of meaningful and actionable conclusions. The life scientists can also help the team to communicate these results in a way relevant to the project's stakeholders. Having dedicated life scientists on the team leads to more efficient model building, qualification, and interpretation of the results, and can help ensure impact.