title: Transformation in the pharmaceutical industry--a systematic analysis of operational evidence.
abstract: Through systematic collection and trending of pharmaceutical data, operational evidence to verify existence of 14 factors affecting the ongoing pharmaceutical transformation has been compiled. These 14 factors are termed transformation triggers. The theoretical evidence in support of these triggers is carried forward from a systematic review of the literature that was conducted previously. Trends in operational evidence and the associated theoretical evidence were compared to identify areas of similarity and contrast. Areas of strong correlation between theoretical evidence and operational evidence included four transformation triggers: a fully integrated pharma network, personalized medicine, translational research, and pervasive computing. Key areas of contrast included three transformation triggers-namely, healthcare management focus, adaptive trials, and regulatory enforcement-for which the operational evidence was stronger than the theoretical evidence.
  The intent of this paper is to provide proof to demonstrate if there is any operational evidence that supports the 14 transformation triggers previously identified during the theoretical part of this research. The theoretical evidence for these triggers was carried forward to this paper for study from an operational perspective. The practical evidence established in this paper was compared with the corresponding theoretical evidence to identify areas of similarity and difference. This resulted in four triggers that had strong relationship between operational and theoretical evidence; they are a fully integrated pharma network, personalized medicine, translational research, and pervasive computing. The areas of difference included three transformation triggers for which the operational evidence was stronger than the theoretical evidence. These were healthcare management focus, adaptive trials, and regulatory enforcement.
authors.affiliation: School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK.
authors.forename: Nader
authors.initials: N
authors.lastname: Shafiei
authors.forename: James L
authors.initials: JL
authors.lastname: Ford
authors.forename: Charles W
authors.initials: CW
authors.lastname: Morecroft
authors.forename: Paulo J
authors.initials: PJ
authors.lastname: Lisboa
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Taylor
authors.forename: Yusra
authors.initials: Y
authors.lastname: Mouzughi
mesh_terms: D003362:Cost-Benefit Analysis; D004345:Drug Industry; D006801:Humans; D008962:Models, Theoretical; D012106:Research
keywords: Fully integrated pharma network; Personalized medicine; Pervasive computing; Pharmaceutical quality; Pharmaceutical transformation; Translational research