title: Fostering culture and optimizing organizational structure for implementing model-based drug development.
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.
authors.affiliation: Discovery Medicine and Clinical Pharmacology, Bristol-Myers Squibb, Princeton, New Jersey, USA. liping.zhang3@bms.com
authors.forename: Liping
authors.initials: L
authors.lastname: Zhang
authors.forename: Sandra R
authors.initials: SR
authors.lastname: Allerheiligen
authors.forename: Richard L
authors.initials: RL
authors.lastname: Lalonde
authors.forename: Donald R
authors.initials: DR
authors.lastname: Stanski
authors.forename: Marc
authors.initials: M
authors.lastname: Pfister
mesh_terms: D000818:Animals; D003198:Computer Simulation; D003299:Cooperative Behavior; D003659:Decision Making, Organizational; D015195:Drug Design; D004345:Drug Industry / Q000458:organization & administration*; D006801:Humans; D008962:Models, Theoretical; D015279:Organizational Culture; D010067:Ownership; D004364:Pharmaceutical Preparations / Q000008:administration & dosage
chemical_list: D004364:Pharmaceutical Preparations