PT  - JOURNAL ARTICLE
AU  - Nader Shafiei
AU  - James L. Ford
AU  - Charles W. Morecroft
AU  - Paulo J. Lisboa
AU  - Mark J. Taylor
AU  - Yusra Mouzughi
TI  - Transformation in the Pharmaceutical Industry—A Systematic Analysis of Operational Evidence
AID  - 10.5731/pdajpst.2013.00924
DP  - 2013 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 307--322
VI  - 67
IP  - 4
4099  - http://journal.pda.org/content/67/4/307.short
4100  - http://journal.pda.org/content/67/4/307.full
SO  - PDA J Pharm Sci Technol2013 Jul 01; 67
AB  - 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. LAY ABSTRACT: 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.