Can QSP Save Lives? Lessons from the Bial Trial Debacle
One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.
Quantitative Systems Pharmacology (QSP) models are mathematical representations that describe our current understanding of a given biology, with a focus on drug development questions. This approach can help understand system complexity and thus improve assessment and prediction of the benefits of a proposed clinical strategy and increase the predictability and reliability of critical drug development decisions.
In this webinar, Certara’s Dr. Neil Benson presented a case study that illustrates how a QSP model was used to evaluate the clinical development path for a FAAH inhibitor as a pain medication