Fostering culture and optimizing organizational structure for implementing model-based drug development

J Clin Pharmacol. 2010 Sep;50(9 Suppl):146S-150S. doi: 10.1177/0091270010376976.

Abstract

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.

MeSH terms

  • Animals
  • Computer Simulation
  • Cooperative Behavior
  • Decision Making, Organizational
  • Drug Design*
  • Drug Industry / organization & administration*
  • Humans
  • Models, Theoretical*
  • Organizational Culture
  • Ownership
  • Pharmaceutical Preparations / administration & dosage

Substances

  • Pharmaceutical Preparations