Towards a sustainable system of drug development

Drug Discovery Today

Volumn 19, Issue 11, 2014, Pages 1711-1720

  Moors, Ellen H M ^a   Cohen, Adam F ^b   Schellekens, Huub ^a,c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG;

COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; HUMAN; INDUSTRIAL PRODUCTION; MERGERS AND ACQUISITIONS; PATENT; PUBLIC-PRIVATE PARTNERSHIP; REIMBURSEMENT; REVIEW; COOPERATION; DRUG LEGISLATION; UNIVERSITY;

COOPERATIVE BEHAVIOR; DRUG DISCOVERY; DRUG INDUSTRY; LEGISLATION, DRUG; PATENTS AS TOPIC; UNIVERSITIES;

EID: 84910640706     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2014.03.004     Document Type: Review

References (85)

1. PWC From Vision to Decision. Pharma 2020 Report 2012 Price Waterhouse Coopers
2. I. Kola, and J. Landis Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3 2004 711 715
3. J. Arrowsmith, and P. Miller Trial watch: Phase II and Phase III attrition rates 2011-2012 Nat. Rev. Drug Discov. 12 2013 569
4. B. Munos Lessons from 60 years of pharmaceutical innovation Nat. Rev. Drug Discov. 8 2009 959 968
5. S.M. Paul How to improve R&D productivity: the pharmaceutical industry's grand challenge Nat. Rev. Drug Discov. 9 2010 203 214
6. F. Pammolli The productivity crisis in pharmaceutical R&D Nat. Rev. Drug Discov. 10 2011 428 438
7. The Congress of the United States Congressional Budget Office Research and Development in the Pharmaceutical Industry 2006 United States Congressional Budget Office
8. A.J. Wood A proposal for radical changes in the drug-approval process N. Engl. J. Med. 355 2006 618 623
9. P. Grootendorst New approaches to rewarding pharmaceutical innovation CMAJ 183 2011 681 685
10. J.A. DiMasi The economics of follow-on drug development: trends in entry rates and the timing of development Pharmacoeconomics 22 2004 1 14
11. M. Olfson, and S.C. Marcus Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research Health Affairs 32 2013 1116 1125
12. J.H. Barton, and E.J. Emmanuel The patent-based pharmaceutical development process JAMA 26 2005 2075 2082
13. S. Morgan The costs of drug development: a systematic review Health Policy 100 2011 4 17
14. C. Gøtzsche Developing a new drug costs less than $100m, not $900m BMJ 246 2013 398
15. J.P. Garnier Rebuilding the R&D engine in big pharma Harv. Bus. Rev. 86 2008 68 70
16. M. Friedman The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281 1999 1728 1734
17. H. Bauchner, and P.B. Fontanarosa Restoring confidence in the pharmaceutical industry JAMA 309 2013 607 609
18. K.A. Sepkowitz History of Medicine: one hundred years of Salvarsan N. Engl. J. Med. 365 2011 291 293
19. Federal Trade Commission Economic Report on Antibiotics Manufacture 1958 Federal Trade Commission
20. W. Comanor Research and competitive product differentiation in the pharmaceutical industry in the United States Economica 31 1964 372 384
21. F. Hawtorn The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant 2005 Wiley
22. J.C. Mahlich Patents and performance in the Japanese pharmaceutical industry: an institution-based view Asia Pac. J. Manag. 27 2010 99 113
23. E.R. Gold Are patents impeding medical care and innovation? PLoS Med. 7 2009 e1000208
24. B. Munos Can open-source drug R&D repower pharmaceutical innovation? Clin. Pharmacol. Ther. 87 2010 534 536
25. European Commission Pharmaceutical Sector Inquiry Final Report. DG Competition 2009 European Commission
26. J. Woodcock Development of novel combination therapies N. Engl. J. Med. 364 2011 985 987
27. H.C. Ebbers Effective pharmaceutical regulation needs alignment with doctors Drug Discov. Today 17 2012 100 103
28. S.R. Forda Priorities for improving drug research, development and regulation Nat. Rev. Drug Discov. 12 2013 247 248
29. A. Breckenridge Evolution of regulatory frameworks Nat. Rev. Drug Discov. 10 2013 3 4
30. E.M. Tansey Medicines and men: Burroughs, Wellcome & Co, and the British drug industry before the Second World War J. R. Soc. Med. 95 2002 411 416
31. J.M. Gabriel A thing patented is a thing divulged: Francis E. Stewart, George S. Davis, and the legitimization of intellectual property rights in pharmaceutical manufacturing, 1879-1911 J. Hist. Med. Allied Sci. 64 2009 135 172
32. N. Oudshoorn United we stand: the pharmaceutical industry, laboratory and clinic in the development of sex hormones into scientific drugs Sci. Technol. Hum. Val. 18 1993 5 24
33. B.L. Ligon Penicillin: its discovery and early development Semin. Pediatr. Infect. Dis. 15 2004 52 57
34. L.G. Zucker, and M.R. Darby Star scientists and institutional transformation: patterns of invention and innovation in the formation of the biotechnology industry Proc. Natl. Acad. Sci. U. S. A. 93 1996 1270 1271
35. M.M. Hopkins Buying big into biotech: scale, financing, and the industrial dynamics of UK biotech, 1980-2009 Indust. Corp. Change 22 2013 903 952
36. IMI (2013) Available from http://www.imi.europa.eu/index-en.html (accessed 10.09.13)
37. J.V. Frangioni The impact of greed on academic medicine and patient care Nat. Biotechnol. 26 2008 503 507
38. G.A. FitzGerald Perestroika in pharma: evolution or revolution in drug development? Mt. Sinai J. Med. 77 2010 327 332
39. C. Ardal Common characteristics of open source software development and applicability for drug discovery: a systematic review Health Res. Policy Syst. 9 2011 36
40. A.S. Kesselheim An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences Milbank Q. 89 2011 450 502
41. E.F. Schmid, and D.A. Smith Pharmaceutical R&D in the spotlight: why is there still unmet medical need? Drug Discov. Today 12 2007 998 1006
42. P. Cuatrecasas Drug discovery in jeopardy J. Clin. Invest. 116 2006 2837 2842
43. O'Connell Neglected diseases Nature 449 2007 157
44. W. Kaplan Priority Medicines for Europe and the World 2013 Update 2013 World Health Organization
45. E.H.M. Moors, and J. Faber Orphan drugs: unmet societal need for non-profitable privately supplied new products Research Policy 36 2007 336 354
46. H.E. Heemstra Orphan drug development across Europe: bottlenecks and opportunities Drug Discov. Today 13 2008 670 676
47. C.J. Thomson Antibacterial research and development in the 21st century - an industry perspective of the challenges Curr. Opin. Microbiol. 7 2004 445 450
48. A.M. Garber An uncertain future for cardiovascular drug development N. Engl. J. Med. 360 2009 1170 1171
49. J.M. Donohue A decade of direct-to-consumer advertising of prescription drugs N. Engl. J. Med. 357 2007 673 681
50. R. Smith Curbing the influence of the drug industry. A British view PLoS Med. 2 2005 821 823
51. I. Rafols Big Pharma, little science? A bibliometric perspective on Big Pharma's R&D decline Technol. Forecast. Social Change 81 2014 22 38
52. W.L. Hill, and C.S. Gary A longitudinal study of the cause and consequences of changes in diversification in the US pharmaceutical industry 1977-1986 Strategic Manage. J. 12 1991 187 199
53. H.G. Eichler Safe drugs and the cost of good intentions N. Engl. J. Med. 360 2009 1378 1380
54. Economist Intelligence Unit Reinventing Biopharma: Strategies for an Evolving Marketplace. The Innovation Imperative in Biopharma. An Economist Intelligence Unit Report 2011 Economist Intelligence Unit
55. H.V. Hogerzeil Big pharma and social responsibility - the Access to Medicine Index N. Engl. J. Med. 369 2013 896 899
56. K.I. Kaitin Deconstructing the drug development process: the new face of innovation Clin. Pharmacol. Ther. 87 2010 356 361
57. M.S. Boguski Repurposing with a difference Science 324 2009 1394 1395
58. N. Novac Challenges and opportunities of drug repositioning Trends Pharm. Sci. 34 2013 267 272
59. W.W. Grody, and T. Getzug Colchicine's other indication - effect of FDA action N. Engl. J. Med. 363 2010 2267 2268
60. E.A. Kitsis Rx for the pharmaceutical industry: call your doctors Hasting Center Rep. 39 2009 18 21
61. J.L. LaMattina The impact of mergers on pharmaceutical R&D Nat. Rev. Drug Discov. 10 2011 559 560
62. I.V. Samarasekera Universities need a new social contract Nature 462 2009 160 161
63. C.J. Tralau-Stewart Drug discovery: new models for industry-academic partnerships Drug Discov. Today 14 2009 95 101
64. P. Valance The future is much closer collaboration between the pharmaceutical industry and academic medical centers Clin. Pharmacol. Ther. 87 2010 525 527
65. J. Woodcock Precompetitive research: a new prescription for drug development? Clin. Pharmacol. Ther. 87 2010 521 523
66. G.A. FitzGerald Drugs, industry, and academia Science 320 2008 1563
67. A. Schuhmacher Models for open innovation in the pharmaceutical industry Drug Discov. Today 2013 http://dx.doi.org/10.1016/j.drudis.2013.07.013
68. L. Bergman Investigator-initiated trials of targeted oncology agents: why independent research is at risk? Ann. Oncol. 21 2010 1573 1578
69. J.A. Dimasi, and H.G. Grabowski Should the patent system for new medicines be abolished? Clin. Pharmacol. Ther. 82 2007 488 490
70. M.J. Higgins, and S.J.H. Graham Balancing innovation and access: patent challenges tip the scales Science 326 2009 370 371
71. S.M. Knowles Intellectual property. Fixing the legal framework for pharmaceutical research Science 327 2010 1083 1084
72. A.S. Kesselheim Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system AAPS J. 9 2007 E306 E311
73. L.W. Musselwhite, and J. Andrews Protect pharmaceutical innovation Science 328 2010 1354
74. A. Yancey, and C.N. Stewart Patent reform in the US: what's at stake for pharmaceutical innovation? Expert Opin. Ther. Pat. 20 2010 603 608
75. E.R. Gold Are patents impeding medical care and innovation? PLoS Med. 7 2010 e1000208
76. M. Boldrin, and D.K. Levine Against Intellectual Monopoly 2008 Cambridge University Press
77. A. Breckenridge Regulatory challenges, reimbursement, and risk-benefit assessment Clin. Pharmacol. Ther. 88 2010 153 154
78. W.P.C. Boon Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe Clin. Pharmacol. Ther. 88 2010 848 853
79. H.C. Ebbers Today's challenges in pharmacovigilance: what can we learn from epoetins? Drug Saf. 34 2011 273 287
80. M.J. Russo, and D. Balekdjian Weighing the outcomes Nat. Biotechnol. 26 2008 173 182
81. H.I. Miller, and D.R. Henderson Governmental influences on drug development: striking a better balance Nat. Rev. Drug Discov. 6 2007 532 539
82. J.T. Cohen Does preventive care save money? N. Engl. J. Med. 358 2008 661 663
83. S.T. Liaw, and G. Petersen Doctor and pharmacist - back to the apothecary Aust. Health Rev. 33 2009 268 278
84. R.S. Taylor Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle BMJ 329 2004 972 975
85. S. Orkie Multinational medicines. Ensuring drug safety in an era of global manufacturing N. Engl. J. Med. 361 2009 737 740