Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost

Area of Science:

• Pharmacometrics and Quantitative Pharmacology
• Drug Development and Regulatory Science

Background:

• Model-informed drug development (MIDD) integrates diverse data to support objective decision-making in drug discovery and development.
• While MIDD's application is increasing, clear portfolio-level evidence demonstrating its impact on efficiency has been limited.

Purpose of the Study:

• To present a methodology and provide examples showcasing the time and cost savings attributable to MIDD at the portfolio level.
• To quantify the value of MIDD in terms of improved trial and program efficiencies.

Main Methods:

• An algorithm was developed to estimate savings from MIDD-related activities across all stages of development within a drug development portfolio.
• Savings were calculated for a typical year between 2021 and 2023, assessing general applicability across multiple programs.

Main Results:

• The systematic application of MIDD approaches resulted in significant time and cost savings across the drug development portfolio.
• Average annualized savings were estimated at approximately 10 months of cycle time and $5 million per program.

Conclusions:

• MIDD significantly improves drug development efficiency, delivering substantial time and cost savings at the portfolio level.
• Increased adoption of MIDD approaches is a key driver for optimizing the efficiency of drug development processes and informing data-driven decisions.