title: White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.
abstract: Pharmaceutical sciences experts and regulators acknowledge that pharmaceutical development as well as drug usage requires more than scientific advancements to cope with current attrition rates/therapeutic failures. Drug disease modeling and simulation (DDM&S) creates a paradigm to enable an integrated and higher-level understanding of drugs, (diseased)systems, and their interactions (systems pharmacology) through mathematical/statistical models (pharmacometrics)(1)-hence facilitating decision making during drug development and therapeutic usage of medicines. To identify gaps and challenges in DDM&S, an inventory of skills and competencies currently available in academia, industry, and clinical practice was obtained through survey. The survey outcomes revealed benefits, weaknesses, and hurdles for the implementation of DDM&S. In addition, the survey indicated that no consensus exists about the knowledge, skills, and attributes required to perform DDM&S activities effectively. Hence, a landscape of technical and conceptual requirements for DDM&S was identified and serves as a basis for developing a framework of competencies to guide future education and training in DDM&S.CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e40; doi:10.1038/psp.2013.16; advance online publication 1 May 2013.
authors.affiliation: GSK, Clinical Pharmacology Modelling & Simulation, Stockley Park, UK.
authors.forename: G
authors.initials: G
authors.lastname: Vlasakakis
authors.forename: E
authors.initials: E
authors.lastname: Comets
authors.forename: A
authors.initials: A
authors.lastname: Keunecke
authors.forename: I
authors.initials: I
authors.lastname: Gueorguieva
authors.forename: P
authors.initials: P
authors.lastname: Magni
authors.forename: N
authors.initials: N
authors.lastname: Terranova
authors.forename: O
authors.initials: O
authors.lastname: Della Pasqua
authors.forename: E C
authors.initials: EC
authors.lastname: de Lange
authors.forename: C
authors.initials: C
authors.lastname: Kloft