An industry perspective on current QSP trends in drug development

Area of Science:

• Pharmacology
• Computational Biology
• Drug Development

Background:

• Quantitative and Systems Pharmacology (QSP) simulations supported the first FDA regulatory decision.
• QSP has matured into an impactful Model-Informed Drug Development (MIDD) tool over five years.
• QSP submissions to regulatory agencies have steadily increased, comprising 4% of IND submissions in 2020.

Purpose of the Study:

• To examine the factors enabling QSP's success in the pharmaceutical industry.
• To clarify QSP's role within the MIDD paradigm.
• To differentiate QSP applications in drug discovery versus clinical development.

Main Methods:

• Review of QSP's integration into regulatory processes.
• Analysis of QSP model types (platforms vs. fit-for-purpose).
• Discussion on the synergy between QSP and pharmacokinetic-pharmacodynamic (PKPD) modeling.

Main Results:

• QSP has transitioned from an emerging discipline to a key component of drug development.
• Regulatory agencies increasingly accept QSP for decision support.
• QSP models offer distinct advantages in both discovery and clinical phases.

Conclusions:

• QSP's successful adoption is driven by its ability to inform critical drug development decisions.
• Understanding QSP's validation requirements is crucial for its effective use.
• QSP is a complementary tool to traditional methods, enhancing the MIDD framework.