Fostering Culture and Optimizing Organizational Structure for Implementing Model‐Based Drug Development

Model‐based drug development (MBDD) is a promising approach to improve decision making in drug development. The pharmaceutical industry has made substantial progress from engaging in empirical decision making to increasingly using pharmacometrics (ie, modeling and simulation [M&S]) as a quantitative decision‐making tool. Focusing on culture and an organizational structure perspective, this commentary summarizes experiences and vision from industry M&S leaders on implementing MBDD. A culture for MBDD needs to have wide acceptance of MBDD, enhanced decision making with probability‐based evidence and transparent rationale, quantitative impact metrics, and a brand that emphasizes cross‐disciplinary collaboration and ownership. An organizational structure for MBDD needs to have a dedicated pharmacometrics function, fine balance between quick wins and impact on long‐term R&D goals, and collaborative MBDD teams among clinical pharmacologists, statisticians, pharmacometricians, and clinicians. Pharmaceutical companies with these characteristics are prepared to fully embrace and implement MBDD.