Transformation in the Pharmaceutical Industry—A Systematic Review of the Literature

References

1. 1.↵
   1. Cockburn I. M.

   Is the pharmaceutical industry in a productivity crisis? Innovation Policy and the Economy 2006, 7, 1–32.

   OpenUrl
2. 2.↵
   1. Cohen J.,
   2. Gangi Q.,
   3. Lineen J.,
   4. Manard A.

   Strategic alternatives in the pharmaceutical industry. Managerial challenges in the Pharmaceutical, Biotech, and Medical Device Industries; Kellogg School of Management: Evanston, IL, 2004.
3. 3.↵
   1. Ahlborn H.,
   2. Henderson S.,
   3. Davies N.

   No immediate pain relief for the pharmaceutical industry. Curr. Opin. Drug Discov. Devel. 2005, 8 (3), 384–391.

   OpenUrlPubMed
4. 4.↵
   1. Peck J. C.,
   2. Crooks G.,
   3. McQuade A.

   Pharma 2029: Pharma's Future Today; Institute for Alternative Futures: Alexandria, VA, 2007.
5. 5.↵
   Deloitte white paper. The Future of the Life Sciences Industries: Transformation amid Rising Risk; Deloitte Touche Tohmatsu: New York, 2009.
6. 6.↵
   1. Grabowski H.,
   2. Kyle M.

   Mergers and Alliances in Pharmaceuticals: Effects on Innovation and R&D Productivity. The Economics of Corporate Governance and Mergers; Edward Elgar Publishing: Northampton, MA, 2008.
7. 7.↵
   Food and Drug Administration. Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. U.S. Department of Health and Human Services: Washington, DC, 2004.
8. 8.↵
   The European Medicines Agency. Road Map to 2010: Preparing the Ground for the Future; The European Medicines Agency: London, 2005.
9. 9.↵
   The European Medicines Agency. Road Map to 2015: The Agency's Contribution to Science, Medicines, Health (draft for public consultation); The European Medicines Agency: London, 2009.
10. 10.↵
    Department of Health and Human Services. FDA Strategic Action Plan: Charting Our Course for the Future; U.S. Department of Health and Human Services: Washington, DC, 2007.
11. 11.↵
    1. Woodcock J.,
    2. Woosley R.

    The FDA critical path initiative and its influence on new drug development. Ann. Rev. Med. 2008, 59, 1–12.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    1. Milne C.-P.

    U.S. and European regulatory initiatives to improve R&D performance. Expert Opinion on Drug Discovery 2006, 1 (1), 11–14.

    OpenUrlPubMed
13. 13.↵
    1. Enkel E.,
    2. Gassmann O.,
    3. Chesbrough H.

    Open R&D innovation: exploring the phenomenon. R&D Management 2009, 39 (4), 311–316.

    OpenUrlWeb of Science
14. 14.↵
    1. Chesbrough H. W.

    The era of open innovation. MIT Sloan Management Review 2003, 44 (3), 35–41.

    OpenUrlWeb of Science
15. 15.↵
    1. Talaga P.

    Open innovation: share or die. Drug Discov. Today 2009, 14 (21–22), 1003–1005.

    OpenUrlPubMed
16. 16.↵
    1. Crommelin D.,
    2. Stolk P.,
    3. Besancon L.,
    4. Shah V.,
    5. Midha K.,
    6. Leufkens H.

    Pharmaceutical sciences in 2020. Nature Reviews Drug Discovery 2010, 9 (2), 99–100.

    OpenUrlCrossRefPubMed
17. 17.↵
    1. Hunter J.,
    2. Stephens S.

    Is open innovation the way forward for big pharma? Nature Reviews Drug Discovery 2010, 9 (2), 87–88.

    OpenUrlCrossRefWeb of Science
18. 18.↵
    1. Ginsberg A.,
    2. Venkatraman N.

    Contingency perspective of organizational strategy: a critical review of the empirical research. Academy of Management Review 1985, 10 (3), 421–434.

    OpenUrlAbstract/FREE Full Text
19. 19.↵
    1. Tranfield D.,
    2. Denyer D.,
    3. Smart P.

    Towards a methodology for developing evidence-informed management knowledge by means of systematic review. British Journal of Management 2003, 14, 207–222.

    OpenUrlCrossRefWeb of Science
20. 20.↵
    1. Meyer A. D.,
    2. Brooks G. R.,
    3. Goes J. B.

    Environmental jolts and industry revolutions: organizational responses to discontinuous change. Strategic Management Journal 1990, 11 (summer special issue: corporate entrepreneurship), 93–110.

    OpenUrlWeb of Science
21. 21.↵
    1. Chan Y.,
    2. Walmsley R.

    Learning and understanding the Kruskal-Wallis one-way analysis-of-cariance-by-ranks test for differences among three or more independent groups. Phys. Ther. 1997, 77 (12), 1755–1761.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    British Telecommunications. Pharma Futurology: Joined-Up Healthcare—2016 and Beyond. Touch Briefings: London, 2007.
23. 23.↵
    Deloitte Consulting. Strategic Flexibility in Life Sciences—From Discovering the Unknown to Exploiting the Uncertain; Deloitte Research: New York, 2002.
24. 24.↵
    1. Hohman M.,
    2. Gregory K.,
    3. Chibale K.,
    4. Smith P. J.,
    5. Ekins S.,
    6. Bunin B.

    Novel web-based tools combining chemistry informatics, biology and social networks for drug discovery. Drug Discov. Today 2009, 14 (5–6), 261–270.

    OpenUrlCrossRefPubMedWeb of Science
25. 25.↵
    1. Lundberg J. M.,
    2. Reilly C.

    The road ahead for large Pharma: long-term science and innovation. Drug Discov. Today 2009, 14 (9–10), 439–441.

    OpenUrlPubMed
26. 26.↵
    ESF–European Medical Research Councils. Nanomedicine: An ESF–European Medical Research Councils (EMRC) Forward Look Report; European Science Foundation: Strasbourg, France, 2005.
27. 27.↵
    1. Woosley R. L.,
    2. Cossman J.

    Drug development and the FDA's Critical Path Initiative. Clin. Pharmacol. Ther. 2007, 81 (1), 129–133.

    OpenUrlCrossRefPubMedWeb of Science
28. 28.↵
    1. Humer F. B.

    The future of healthcare and the pharmaceutical industry—a CEO view. Journal of Men's Health & Gender 2004, 1 (1):107–109.

    OpenUrl
29. 29.↵
    1. Jain K. K.

    The role of nanobiotechnology in drug discovery. Drug Discov. Today 2005, 10 (21), 1435–1442.

    OpenUrlCrossRefPubMedWeb of Science
30. 30.↵
    1. Phan J.,
    2. Moffitt R.,
    3. Stokes T.,
    4. Liu J.,
    5. Young A. N.,
    6. Nie S.,
    7. Wang M. D.

    Convergence of biomarkers, bioinformatics and nanotechnology for individualized cancer treatment. Trends Biotechnol. 2009, 27 (6), 350–358.

    OpenUrlCrossRefPubMedWeb of Science
31. 31.↵
    1. Aspinall M. G.,
    2. Hamermesh R. G.

    Realizing the promise of personalized medicine. Harv. Bus. Rev. 2007, 85 (10), 108–117, 165.

    OpenUrlPubMedWeb of Science
32. 32.↵
    1. Guidi G. C.,
    2. Lippi G.

    Will “personalized medicine” need personalized laboratory approach? Clin. Chim. Acta 2009, 400 (1–2), 25–29.

    OpenUrlCrossRefPubMed
33. 33.↵
    1. Adams J.,
    2. Mounib E.,
    3. Pai A.,
    4. Stuart N.,
    5. Thomas R.,
    6. Tomaszewicz P.

    Healthcare 2015: Win-Win or Lose-Lose? IBM Global Business Services: Somers, NY, 2006.
34. 34.↵
    1. Mulder J.,
    2. Fezza T.,
    3. Marcello R.

    Reinventing Innovation in Large Pharma; Deloitte Development LLC: New York, 2008.
35. 35.↵
    1. Ginsburg G. S.,
    2. McCarthy J. J.

    Personalized medicine: revolutionizing drug discovery and patient care. Trends Biotechnol. 2001, 19 (12), 491–496.

    OpenUrlCrossRefPubMedWeb of Science
36. 36.↵
    1. O'Connell D.,
    2. Roblin D.

    Translational research in the pharmaceutical industry: from bench to bedside. Drug Discov. Today 2006, 11 (17–18), 833–838.

    OpenUrlCrossRefPubMedWeb of Science
37. 37.↵
    1. Marrer E.,
    2. Dieterle F.

    Promises of biomarkers in drug development—a reality check. Chem. Biol. Drug Des. 2007, 69 (6), 381–394.

    OpenUrlCrossRefPubMedWeb of Science
38. 38.↵
    1. Michelson S.,
    2. Sehgal A.,
    3. Friedrich C.

    In silico prediction of clinical efficacy. Curr. Opin. Biotechnol. 2006, 17 (6), 666–670.

    OpenUrlPubMed
39. 39.↵
    1. Zerhouni E. A.

    Translational research: moving discovery to practice. Clin. Pharmacol. Ther. 2007, 81 (1), 1621–1623.

    OpenUrl
40. 40.↵
    1. Wehling M.

    Translational medicine: can it really facilitate the transition of research “from bench to bedside”? Eur. J. Clin. Pharmacol. 2006, 62 (2), 91–95.

    OpenUrlPubMedWeb of Science
41. 41.↵
    1. Saha D.,
    2. Mukherjee A.

    Pervasive computing: a paradigm for the 21st century. IEEE Computer Society 2003, 36 (3), 25–31.

    OpenUrl
42. 42.↵
    1. Satyanarayanan M.

    Pervasive computing: vision and challenges. IEEE Personal Communications 2001, 8 (4), 10–17.

    OpenUrl
43. 43.↵
    1. Clemensen J.,
    2. Larsen S. B.,
    3. Bardram J. E.

    Developing pervasive e-health for moving experts from hospital to home. IADIS International Journal on WWW/Internet 2004, 2 (2), 57–68.

    OpenUrl
44. 44.↵
    1. Scheffler M.,
    2. Hirt E.

    Wearable devices for telemedicine applications. Journal of Telemedicine and Telecare 2005, 11 (1), 11–14.

    OpenUrlAbstract/FREE Full Text
45. 45.↵
    1. Osmani V.,
    2. Balasubramaniam S.,
    3. Botvich D.

    Human activity recognition in pervasive health-care: Supporting efficient remote collaboration. Journal of Network and Computer Applications 2008, 31, 628–655.

    OpenUrl
46. 46.↵
    1. Floerkemeier C.,
    2. Siegemund F.

    Improving the Effectiveness of Medical Treatment with Pervasive Computing Technologies. Second International Workshop on Ubiquitous Computing for Pervasive Healthcare Applications, Seattle, WA, 2003.
47. 47.↵
    1. Pandian P. S.,
    2. Mohanavelu K.,
    3. Safeer K. P.,
    4. Kotresh T. M.,
    5. Shakunthala D. T.,
    6. Gopal P.,
    7. Padaki V. C.

    Smart Vest: wearable multi-parameter remote physiological monitoring system. Med. Eng. Phys. 2008, 30 (4), 466–477.

    OpenUrlCrossRefPubMed
48. 48.↵
    1. Engin M.,
    2. Demirel A.,
    3. Engin E. Z.,
    4. Fedakar M.

    Recent developments and trends in biomedical sensors. Measurement 2005, 37 (2), 173–188.

    OpenUrlCrossRefWeb of Science
49. 49.↵
    1. Sriram J.,
    2. Shin M.,
    3. Kotz D.,
    4. Rajan A.,
    5. Sastry M.,
    6. Yarvis M.

    Challenges in Data Quality Assurance in Pervasive Health Monitoring Systems. Future of Trust in Computing: Wiesbaden, Germany, 2009.
50. 50.↵
    1. Orwat C.,
    2. Graefe A.,
    3. Faulwasser T.

    Towards pervasive computing in health care—a literature review. BMC Medical Informatics and Decision Making 2008, 8 (26), 1–18.

    OpenUrlCrossRef
51. 51.↵
    1. Buyya R.,
    2. Shin Yeo C.,
    3. Venugopal S.,
    4. Broberg J.,
    5. Brandic I.

    Cloud computing and emerging IT platforms: vision, hype, and reality for delivering computing as the 5th utility. Future Generation Computer Systems 2009, 25 (6), 599–616.

    OpenUrl
52. 52.↵
    1. Sloan K.

    Security in a virtualized world. Network Security 2009, 8, 15–18.

    OpenUrl
53. 53.↵
    1. Sneha S.,
    2. Varshney U.

    Enabling ubiquitous patient monitoring: model, decision protocols, opportunities and challenges. Decision Support Systems 2009, 46 (3), 606–619.

    OpenUrl
54. 54.↵
    1. Shah V.,
    2. Besancon L. J. R.,
    3. Stolk P.,
    4. Tucker G.,
    5. Crommelin D. J. A.

    The pharmaceutical sciences in 2020—report of a conference organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP). Eur. J. Pharm. Sci. 2009, 38 (5), 419–425.

    OpenUrlPubMed
55. 55.↵
    1. Foster B. C.

    Foresight scanning: future directions of clinical and pharmaceutical research. J. Pharm. Sci. 2008, 11 (4), 108–122.

    OpenUrl
56. 56.↵
    1. Shuchman M.

    Commercializing clinical trials—risks and benefits of the CRO boom. New Engl. J. Med. 2007, 357 (14), 1365–1368.

    OpenUrlCrossRefPubMedWeb of Science
57. 57.↵
    PricewaterhouseCoopers. Pharma 2020: Virtual R&D—Which Path Will You Take? 2008.
58. 58.↵
    1. Love B.

    Virtual pharmaceutical R&D: a strategy for the millennium? Pharm. Sci. Technol. Today 1998, 1 (3), 89–90.

    OpenUrl
59. 59.↵
    1. Heemstra H. E.,
    2. de Vrueh R. L. A.,
    3. van Weely S.,
    4. Buller H. A.,
    5. Leufkens H. G. M.

    Orphan drug development across Europe: bottlenecks and opportunities. Drug Discov. Today 2008, 13 (15–16), 670–676.

    OpenUrlPubMed
60. 60.↵
    1. Fraser H.

    Pharma 2010: A bitter sweet pill. Specra Online 2006, 2, http://newsweaver.co.uk/spectrajournal/e_000118357000063547.cfm?x=b11,0,w. Accessed July 2010.
61. 61.↵
    1. Miller R.,
    2. Ewy W.,
    3. Corrigan B. W.,
    4. Quellet D.,
    5. Hermann D.,
    6. Kowalski K. G.,
    7. Lockwood P.,
    8. Koup J. R.,
    9. Donevan S.,
    10. El-Kattan A.,
    11. Li C. S.,
    12. Werth J. L.,
    13. Feltner D. E.,
    14. Lalonde R. L.

    How modeling and simulation have enhanced decision making in new drug development. J. Pharmacokinet. Pharmacodyn. 2005, 32 (2), 185–197.

    OpenUrlCrossRefPubMedWeb of Science
62. 62.↵
    1. Boswell C.

    The future of pharmaceuticals is in targeted treatment, says IBM. Chemical Market Reporter 2002, 262 (22), 12.

    OpenUrl
63. 63.↵
    1. Prendergast J.,
    2. Yeomans M.,
    3. Fraser H. E.

    Pharma 2010—The Value-Creating Supply Chain; IBM Global Services: Somers, NY; 2004.
64. 64.↵
    1. Funning S.,
    2. Grahnen A.,
    3. Eriksson K.,
    4. Kettis-Linblad A.

    Quality assurance within the scope of good clinical practice (GCP)—what is the cost of GCP-related activities? A survey within the Swedish Association of the Pharmaceutical Industry (LIF)'s members. Quality Assurance Journal 2009, 12 (1), 3–7.

    OpenUrl
65. 65.↵
    Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting. Implementation of ICH Q8, Q9, and Q10 Quality Guidelines—Topic Introduction and FDA Perspective. U.S. Food and Drug Administration: Rockville, MD, 2009.
66. 66.↵
    1. Bass S.,
    2. Klasmeier C.,
    3. Lugard M. J. F.,
    4. Silvis L. R.,
    5. Simon C.-M.

    U.S. Food and Drug Administration and European Medicines Agency Enter into New Good Clinical Practices Collaboration. Sidley Austin LLP: Chicago, IL, 2009.
67. 67.↵
    1. Calfee J. E.

    Playing catch-up—the FDA, science, and drug regulation. American Enterprise Institute for Public Policy Research 2006, 5, http://www.aei.org/outlook/24130. Accessed July 2010.
68. 68.↵
    U.S. Food and Drug Administration (FDA). Critical Path Opportunities Report; FDA: Rockville, MD, 2006.
69. 69.↵
    1. Yu L. X.

    Pharmaceutical quality by design: product and process development, understanding, and control. Pharm. Res. 2008, 25 (4), 781–791.

    OpenUrlCrossRefPubMed
70. 70.↵
    1. Garcia T.,
    2. Cook G.,
    3. Nosal R.

    PQLI key topics—criticality, design space, and control strategy. J. Pharm. Innov. 2008, 3 (2), 60–68.

    OpenUrl
71. 71.↵
    Visiongain market research report. Live-Licensing & In-Life Testing: R&D Processes and Regulation for New Drugs, 2008–2020; Visiongain: London, 2008.
72. 72.↵
    Health Canada. Progressive Licensing Model; Health Canada: Ottawa, Ontario, 2007.
73. 73.↵
    1. Wright J. M.

    Progressive drug licensing—an opportunity to achieve transparency and accountability. CMAJ 2007, 176 (13), 1848–1849.

    OpenUrlFREE Full Text
74. 74.↵
    1. Hebert P. C.

    Progressive licensing needs progressive open debate. CMAJ 2007, 176 (13), 1801.

    OpenUrlFREE Full Text
75. 75.↵
    1. Lexchin J.

    Progressive licensing of drugs—music or noise? Healthcare Policy 2008, 3 (4), 11–15.

    OpenUrlPubMed
76. 76.↵
    1. Hamburg M.

    Effective Enforcement and Benefits to Public Health. Food and Drug Administration: Rockville, MD, 2009, http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm. Accessed June 2010.
77. 77.↵
    1. Basile E. M.,
    2. Furman F. P.,
    3. Lee M.

    FDA's Outlook under the New Administration. King & Spalding Client Alert: Washington, DC, 2009.
78. 78.↵
    1. Sager B.

    Scenarios on the future of biotechnology. Technological Forecasting and Social Change 2001, 68 (2), 109–129.

    OpenUrl
79. 79.↵
    U.S. National Intelligence Council. Global Trends 2015: A Dialogue about the Future with Nongovernment Experts; U.S. Government Printing Office: Washington, DC, 2000.
80. 80.↵
    1. Schmid E. F.,
    2. Smith D. A.

    Is pharmaceutical R&D just a game of chance or can strategy make a difference? Drug Discov. Today 2004, 9 (1), 18–26.

    OpenUrlCrossRefPubMed
81. 81.↵
    1. Cooke P.

    Biotechnology clusters in the UK: lessons from localization in the commercialization of science. Small Business Economics 2001, 17 (1–2), 43–59.

    OpenUrl
82. 82.↵
    1. Wagner V.,
    2. Dullaart A.,
    3. Bock A.-K.,
    4. Zweck A.

    The emerging nanomedicine landscape. Nature Biotechnol. 2006, 24 (10), 1211–1217.

    OpenUrlCrossRefPubMedWeb of Science
83. 83.↵
    European Science Foundation. Nanoscience and the Long-Term Future of Information Technology (NSIT). European Science Foundation: Strasbourg, France, 2006.
84. 84.↵
    1. Sahoo S. K.,
    2. Parveen S.,
    3. Panda J. J.

    The present and future of nanotechnology in human health care. Nanomedicine 2007, 3 (1), 20–31.

    OpenUrlPubMed
85. 85.↵
    1. Wiek A.,
    2. Gasser L.,
    3. Siegrist M.

    Systemic scenarios of nanotechnology: sustainable governance of emerging technologies. Futures 2009, 41 (5), 284–300.

    OpenUrl
86. 86.↵
    Institute for Alternative Futures and the Draper Laboratory. Envision a Small Future; Institute for Alternative Futures: Alexandria, VA, 2005.
87. 87.↵
    1. Rauwerda H.,
    2. Roos M.,
    3. Hertzberger B. O.,
    4. Breit T. M.

    The promise of a virtual lab in drug discovery. Drug Discov. Today 2006, 11 (5–6), 228–236.

    OpenUrlCrossRefPubMedWeb of Science
88. 88.↵
    1. Ananthaswamy A.

    March of the motes. New Scientist 2003, 179 (2409), 26.

    OpenUrl