Changing R&D models in research-based pharmaceutical companies

Journal of Translational Medicine

Volumn 14, Issue 1, 2016, Pages

  Schuhmacher, Alexander ^a   Gassmann, Oliver ^b   Hinder, Markus ^c  

^a REUTLINGEN UNIVERSITY   (Germany)

^b UNIVERSITY OF ST GALLEN   (Switzerland)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

COST CONTROL; DRUG APPROVAL; DRUG COST; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG RESEARCH; FINANCIAL MANAGEMENT; HIGH THROUGHPUT SCREENING; PROBABILITY; REIMBURSEMENT; REVIEW; COOPERATION; RESEARCH; RISK FACTOR; THEORETICAL MODEL; TIME FACTOR;

COOPERATIVE BEHAVIOR; DRUG INDUSTRY; MODELS, THEORETICAL; RESEARCH; RISK FACTORS; TIME FACTORS;

EID: 84965025557     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/s12967-016-0838-4     Document Type: Review

References (61)

1. Evaluate Pharma. World Preview 2015. 2015. http://info.evaluategroup.com/rs/607-YGS-364/images/wp15.pdf. Accessed 15 Feb 2016.
2. European Commission-Joint Research Centre. The 2015 EU Industrial R&D investment scoreboard. http://iri.jrc.ec.europa.eu/scoreboard15.html. Accessed 15 Feb 2016.
3. Munos B. Lessons from 60years of pharmaceutical innovation. Nat Rev Drug Discov. 2009;8:959-68.
4. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004;3:711-6.
5. Mullard A. 2010 FDA drug approvals. Nat Rev Drug Discov. 2011;10:82-5.
6. Mullard A. 2011 FDA drug approvals. Nat Rev Drug Discov. 2012;11:91-4.
7. Mullard A. 2012 FDA drug approvals. Nat Rev Drug Discov. 2013;12:87-90.
8. Mullard A. 2013 FDA drug approvals. Nat Rev Drug Discov. 2014;13:85-9.
9. Mullard A. 2014 FDA drug approvals. Nat Rev Drug Discov. 2015;14:77-81.
10. Schuhmacher A, et al. Value creation in the pharmaceutical industry: the critical path to innovation. Wiley; 2016. ISBN 978-3-527-33913-6.
11. 2014 CMR International Pharmaceutical R&D Factbook.
12. Paul SM, et al. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov. 2010;9:203-14.
13. DiMasi JA. Risks in new drug development: approval success rates for investigational drugs. Clin Pharmacol Ther. 2001;69:297-307.
14. Prinz F, et al. Believe it or not: how much can we rely on published data on potential drug targets? Nat Rev Drug Discov. 2011;10:712-3.
15. Bergren R, et al. Outlook for the next 5years in drug innovation. Nat Rev Drug Discov. 2012;11:435-6.
16. Agarwal P. Novelty in the target landscape of the pharmaceutical industry. Nat Rev Drug Discov. 2013;12:575-6.
17. Sams-Dodd F. Target-based drug discovery: is something wrong? Drug Discov Today. 2005;10:139-47.
18. Swinney DC, Anthony J. How were new medicines discovered? Nat Rev Drug Discov. 2011;11:507-19.
19. Scannell JW, et al. Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov. 2012;11:191-200.
20. Pammolli F, et al. The productivity crisis in pharmaceutical R&D. Nat Rev Drug Discov. 2011;10:428-38.
21. Arrowsmith J, Miller P. Trial Watch: phase II and Phase III attrition rates 2011-2012. Nat Rev Drug Discov. 2013;12:569.
22. Cook D, et al. Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework. Nat Rev Drug Discov. 2014;13:419-31.
23. DiMasi JA, et al. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 2010;87:272-7.
24. Abrantes-Metz R et al. Pharmaceutical Development Phases: a duration analysis. Working paper no. 274. US Federal Trade Commission: Bureau of Economics. 2004. http://www.ftc.gov/be/workpapers/wp274.pdf. Accessed 15 Feb 2016.
25. Hay M, et al. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40-51.
26. Kaitin KI, DiMasi JA. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther. 2011;89(2):183-8.
27. Dickson M, Gagnon JP. Key factors in the rising cost of new drug discovery and development. Nat Rev Drug Discov. 2004;3:417-29.
28. DiMasi JA. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;23:151-85.
29. DiMasi JA. Cost of innovation in the pharmaceutical industry. J Health Econ. 1991;10:107-42.
30. Harper M. The truly staggering cost of inventing new drugs. 2012. http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-newdrugs/#2ce906714477.
31. Danzon PM. Mergers and acquisitions in the pharmaceutical and biotech industries. Manag Decis Econ. 2007;28:307-28.
32. LaMattina JL. The impact of mergers on pharmaceutical R&D. Nat Rev Drug Discov. 2011;10:559-60.
33. Ornaghi C. Mergers and innovation in big pharma. Int J Ind Organ. 2009;27:70-9.
34. Comanor WS, Scherer FM. Mergers and innovation in the pharmaceutical industry. J Health Econ. 2013;32:106-13.
35. DiMasi JA, et al. The impact of collaborative and risk-sharing innovation approaches on clinical and regulatory cycle times. Ther Innov Regul Sci. 2014;48:482-7.
36. Kruse S, et al. Pharmaceutical RandD productivity: the role of alliances. J Commer Biotechnol. 2014;20:11-20.
37. Garnier JP. Rebuilding the R&D engine in big pharma. Harv Bus Rev. 2008;86:68-79.
38. Douglas FL, et al. The case for entrepreneurship in R&D in the pharmaceutical industry. Nat Rev Drug Discov. 2010;9:683-9.
39. Tralau-Stewart CJ, et al. Drug discovery: new models for industry-academic partnerships. Drug Discov Today. 2009;14:95-101.
40. Regalado A. Money seeks idea. MIT. Technol Rev. 2012;115(6):75-6.
41. Ekins S, et al. Four disruptive strategies for removing drug discovery bottlenecks. Drug Discov Today. 2013;18:265-71.
42. Frye S, et al. US academic drug discovery. Nat Rev Drug Discov. 2011;10:409-10.
43. Kling J. Biotechs follow big pharma lead back into academia. Nat Biotechnol. 2011;29:555-6.
44. Schuhmacher A, et al. Models for open innovation in the pharmaceutical industry. Drug Discov Today. 2013;18:1133-7.
45. Citeline. Pharma R&D annual review. 2013. http://www.citeline.com/wp-content/uploads/Annual-Review-2014b.pdf. Accessed 28 Oct 2014.
46. KPMG. Outsourcing in the pharmaceutical industry: 2011 and beyond. 2012 https://www.kpmg.com/Ca/en/IssuesAndInsights/ArticlesPublications/Documents/Outsourcing-pharmaceutical-industry.pdf. Accessed 15 Mar 2016.
47. Mehta S, Peters LS. Outsourcing a core competency. Res Technol Manag. 2007;5:28-33.
48. Clark DE. Outsourcing lead optimization: the eye of the storm. Drug Discov Today. 2010;16:147-57.
49. Kermani F. Drug discovery partnerships between UK CROs and the Swiss pharma sector. Pharm Technol Eur. 2014;26:8-11.
50. Levy H. Integrated outsourcing transforms and increases R&D productivity. J Commer Biotechnol. 2013;19:49-54.
51. Ratner M. Pfizer reaches out to academia-again. Nat Biotechnol. 2011;29:3-4.
52. Harrison C. GlaxoSmithKline opens the door on clinical data sharing. Nat Rev Drug Discov. 2011;11:891-2.
53. Strauss S. Pharma embraces open source models. Nat Biotechnol. 2010;7:631-4.
54. Munos B. Can open-source drug R&D repower pharmaceutical innovation? Clin Pharmacol Ther. 2010;87:534-6.
55. Roijakkers N, Hagedorn J. Inter-firm R&D partnering in pharmaceutical biotechnology since 1975: trends, patterns, and networks. Res Policy. 2006;35:431-46.
56. Lessl M, et al. Grants4Targets- an innovative approach to translate ideas from basic research into novel drugs. Drug Discov Today. 2011;16:288-92.
57. Dorsch H, et al. Grants4Targets-an open innovation initiative to foster drug discovery collaborations between academia and the pharmaceutical industry. Nat Rev Drug Discov. 2015;14:74-6.
58. Owens PK. A decade of innovation in pharmaceutical R&D: the Chorus model. Nat Rev Drug Discov. 2015;14:17-28.
59. Longman R. Lilly's chorus experiment. In Vivo. 2007;25(5):1-5.
60. PWC. Pharma emerging markets 2.0. 2013. http://www.strategyand.pwc.com/media/file/Strategyand_Pharma-Emerging-Markets-2.0.pdf. Accessed 15 Nov 2015.
61. KPMG. Future Pharma. 2011. https://www.kpmg.com/BE/en/IssuesAndInsights/ArticlesPublications/Documents/future-pharma.pdf. Accessed 15 Nov 2015.