title: Model-based drug development: strengths, weaknesses, opportunities, and threats for broad application of pharmacometrics in drug development.
abstract: Systematic implementation of model-based drug development (MBDD) to drug discovery and development has the potential to significantly increase the rate of medical breakthroughs and make available new and better treatments to patients. An analysis of the strengths, weaknesses, opportunities, and threats (ie, SWOT) was conducted through focus group discussions that included 24 members representing 8 pharmaceutical companies to systematically assess the challenges to implementing MBDD into the drug development decision-making process. The application of the SWOT analysis to the successful implementation of MBDD yielded 19 strengths, 27 weaknesses, 34 opportunities, and 22 threats, which support the following conclusions. The shift from empirical drug development to MBDD requires a question-based mentality; early, proactive planning; dynamic access to multisource data; quantitative knowledge integration; multidisciplinary collaboration; effective communication and leadership skills; and innovative, impactful application of pharmacometrics focused on enhancing quantitative decision making. The ultimate goal of MBDD is to streamline discovery and development of innovative medicines to benefit patients.
authors.affiliation: GlaxoSmithKline, Collegeville, PA 19426, USA. Jeffrey.d.wetherington@gsk.com
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Wetherington
authors.forename: Marc
authors.initials: M
authors.lastname: Pfister
authors.forename: Christopher
authors.initials: C
authors.lastname: Banfield
authors.forename: Julie A
authors.initials: JA
authors.lastname: Stone
authors.forename: Rajesh
authors.initials: R
authors.lastname: Krishna
authors.forename: Sandy
authors.initials: S
authors.lastname: Allerheiligen
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Grasela
mesh_terms: D003657:Decision Making; D015195:Drug Design; D055808:Drug Discovery / Q000379:methods; D004345:Drug Industry / Q000458:organization & administration*; D017144:Focus Groups; D006801:Humans; D033183:Interdisciplinary Communication; D008954:Models, Biological; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations