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Research ArticleResearch

Transformation in the Pharmaceutical Industry—A Systematic Analysis of Operational Evidence

Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor and Yusra Mouzughi
PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 307-322; DOI: https://doi.org/10.5731/pdajpst.2013.00924
Nader Shafiei
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;
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  • For correspondence: N.Shafiei@2009.ljmu.ac.uk
James L. Ford
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;
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Charles W. Morecroft
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK;
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Paulo J. Lisboa
2School of Computing and Mathematical Sciences, Liverpool John Moores University, Liverpool, UK; and
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Mark J. Taylor
2School of Computing and Mathematical Sciences, Liverpool John Moores University, Liverpool, UK; and
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Yusra Mouzughi
3Liverpool Business School, Liverpool John Moores University Liverpool, UK
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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.

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.

  • Pharmaceutical transformation
  • Pharmaceutical quality
  • Fully integrated pharma network
  • Personalized medicine
  • Translational research
  • Pervasive computing
  • © PDA, Inc. 2013
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PDA Journal of Pharmaceutical Science and Technology: 67 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 4
July/August 2013
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Transformation in the Pharmaceutical Industry—A Systematic Analysis of Operational Evidence
Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor, Yusra Mouzughi
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 307-322; DOI: 10.5731/pdajpst.2013.00924
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Keywords

  • Pharmaceutical transformation
  • Pharmaceutical quality
  • Fully integrated pharma network
  • Personalized medicine
  • Translational research
  • Pervasive computing

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Transformation in the Pharmaceutical Industry—A Systematic Analysis of Operational Evidence
Nader Shafiei, James L. Ford, Charles W. Morecroft, Paulo J. Lisboa, Mark J. Taylor, Yusra Mouzughi
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 307-322; DOI: 10.5731/pdajpst.2013.00924

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