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PRIVATE–PUBLIC SECTOR GROUPS

A Pitfall in Drug Discovery

3.9 PRIVATE–PUBLIC SECTOR GROUPS

3.9.1 National Centre for Advancing Translational Sciences

NCATS is supported by the NIH to promote innovative methods and tech- nologies for diverse therapeutic areas. It was established in 2012 with a running budget of US$575 million. The NCATS Strategic Alliances Office aims to support industry and academia interactions and partnership with other NCATS laboratories and scientists including universities, pharma- ceutical companies, and biotechnology companies. Experts predict that NCATS could help rescue the Valley of Death situation [54].

3.9.2 Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) was established in 2008 by the European Federation of Pharmaceutical Industries and the European Commission. It is the largest public–private partnership, created to improve development strategies in Europe. It is concerned with the development of tools to predict efficacy, safety, and the management systems in the drug development program [55]. It supports a public–private partnership initiative that encourages competitors to apply for government funds. The IMI is an open innovation program with a mandate to improve the drug development process. An implementation plan with a €2 billion budget was provided by governments and industry participants.

3.9.3 European Federation for Pharmaceutical Sciences

The European Federation for Pharmaceutical Sciences was established with a mandate of advancing the interests of scientists in industry, academia, gov- ernment, and other institutions engaged in drug research, development, regulation, and policymaking in Europe.

3.9.4 The Centre for Drug Research and Development

The Centre for Drug Research and Development is Canada’s national, not-for-profit drug development and commercialization center. It was established to derisk discoveries of publicly funded research while provid- ing investment opportunities for the private sector to bridge the Valley of Death in drug discovery [56]. The National Chemical Genomics Centre has a screening capacity equivalent to that of a major pharmaceutical company [57]. The Molecular Libraries program is an NIH Roadmap Initiative that is focused on promoting chemical biology research that applies high throughput screening that identifies viable small molecules with promising drug-like characteristics [58].

REFERENCES

[1] Graul A, Revel L, Rosa E, Cruces E. Overcoming the obstacles in the pharma/biotech industry: 2008 update. Drug News Perspect 2009;22:39–51.

[2] Dickson M, Gagnon JP. Key factors in the rising cost of new drug discovery and development. Nat Rev Drug Discov 2004;3(5):417–29.

[3] Steinmetz KL, Spack EG. The basics of preclinical drug development for neurodegenerative disease indications. BMC Neurol 2009;9(Suppl. 1):S2.

[4] Lehoux P, Daudelin G, Williams-Jones B, Denis J-L, Longo C. How do business model and health technology design influence each other? Insights from a longitudinal case study of three academic spin-offs. Res Policy 2014;43:1025–38.

Social Aspects of Drug Discovery, Development and Commercialization 80

[5] Pierrakis Y. Venture capital - now and after the dotcom crash. Research report. NESTA 2010.

[6] Ernst and Young. Beyond borders: matters of evidence. Global Biotechnology Industry Report; 2013. Available from: http://www.ey.com/Publication/vwLUAssets/Beyond_

borders/$FILE/Beyond_borders.pdf [accessed 08.12.2014].

[7] Butler D. Translational research: crossing the Valley of Death. Nature 2008;453:840–2.

[8] Dosi G. Technological paradigms and technological trajectories: a suggested interpreta- tion of the determinants and directions of technological change. Res Policy 1982;11(3):

147–62.

[9] Down M, Blackburn T. The challenges of the changing drug discovery model. Drug Discov World 2012. Available from: http://www.ddw-online.com/business/p191021-the- challenges-of-the-changing-drug-discovery-model-fall-12.html. [accessed 14.12.2014].

[10] Teece D. The competitive challenge: strategies for industrial innovation and renewal.

Science 1987;239(4845):1320–1.

[11] Tegarden LF, Lamb WB, Hatfield DE, Ji FX. Bringing emerging technologies to market:

does academic research promote commercial exploration and exploitation. IEEE Trans Eng Manage 2012;59(4):598–608.

[12] Collins FS. Reengineering translational science: the time is right. Sci Transl Med 2011;3:90cm17.

[13] Pober JS, Neuhauser CS, Pober JM. Obstacles facing translational research in academic medical centers. FASEB J 2001;15:2303–13.

[14] Hopkins AL, Groom CR. The druggable genome. Nat Rev Drug Discov 2002;1:727–30.

[15] Roberts SF, Fischhoff MA, Sakowski SA, Feldman EL. Perspective: transforming science into medicine: how clinician–scientists can build bridges across research’s “Valley of Death”. Acad Med 2012;87(3):266–70.

[16] Guild PF. Commercializing inventions resulting from university research; analyzing the impact of technology characteristics on subsequent business models. Technovation 2011;31:151–60.

[17] Bridging the “Valley of Death”: improving the commercialization of research. House of Commons Science and Technology Select Committee inquiry Royal Society of Chemistry Response. House of Commons Science and Technology Committee. Eighth Report of Session 2012-13. Available from: http://www.publications.parliament.uk/

pa/cm201213/cmselect/cmsctech/348/348.pdf [accessed 08.12.2014].

[18] Curry S, Brown R. The target product profile as a planning tool in drug discovery research. Pharmatech 2003;67–71. Available from: http://www.fda.gov/downloads/

drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf [accessed 08.12.2014].

[19] Tebbey PW. Target product profile: a renaissance for its definition and use. J Med Market 2009;9(4):301–7.

[20] Spilker B. Guide to Drug Development. A Comprehensive Review and Assessment.

New York: Wolters Kluwer, Lippincott Williams & Wilkins; 2009. p. 976.

[21] Available from: http://www.pmlive.com/top_pharma_list/global_revenues

[22] Robins-Roth C. From Alchemy to IPO: The Business of Biotechnology. Cambridge, MA: Perseus Publishing; 2000.

[23] The Economist. Climbing the helical Staircase 29 March 2003; 8317:3-7.

[24] Spilker B. Guide to Drug Development. A Comprehensive Review and Assessment.

New York: Wolters Kluwer, Lippincott Williams & Wilkins; 2009. p. 121 [chapter 12].

[25] Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 6th ed. April 30, 2014. 200 Pages – Pub ID: KLI5237347.

[26] Taunton-Rigby A. Does biotech need pharma? Drug Discov Today 2001;6:1131–3.

[27] Gottinger H, Umali CL. Strategic alliance in global biotech pharma industries. Open Business J 2008;1:10–24.

[28] Rai AK. Fostering cumulative innovation in the biopharmaceutical industry. Berkeley Tech L J 2001;813:815–8.

[29] Higgins MJ. The allocation of control rights in pharmaceutical alliances. Soc Sci Res Netw 2006. Working Paper No. 918980.

[30] Latest News: Merck partners with academic scientists and biotechnology entrepreneurs to create the California Institute for Biomedical Research (Calibr). Available from:

http://www.merck.com/licensing/our-partnership/Calibr-Licenses-partnership.html [accessed 08.12.2014].

[31] Advancing medical breakthroughs. Available from: http://www.pfizer.com/partnering/

partnership_highlights/

[32] Mullard A. Partnering between pharma peers on the rise. Nat Rev Drug Discov 2011;10:561–2.

[33] Vernon JA, Golec JH, Dimasi JA. Drug development costs when financial risk is measured using the Fama-French three-factor model. Health Econ 2010;19(8):

1002–5.

[34] Hollingsworth JR. In: Stapleton D, editor. Creating a Tradition of Biomedical Research.

New York: Rockefeller University Press; 2004. p. 17–63.

[35] Taube-Koret Center Annual Report. Available from: http://www.gladstoneinstitutes.

org/u/sfinkbeiner/taube-koret/Resources.html [accessed 09.12.2014].

[36] Finkhbiner S. Bridging the Valley of Death of therapeutics for neurodegeneration. Nat Med 2010;16(11):1227–31.

[37] Yua H, Adedoyin A. ADME-Tox in drug discovery: integration of experimental and computational technologies. Drug Discov Today 2003;8(18):852–61.

[38] Penzotti JE, Landrum GA, Putta S. Building predictive ADMET models for early decisions in drug discovery. Curr Opin Drug Discov Devel 2004;7:49–60.

[39] Kennedy T. Managing the drug discovery/development interface. Drug Discov Tech 1997;2:436–41.

[40] Steele SJ. Working with the CTSA Consortium: what we bring to the table. Sci Transl Med 2010;2:63mr5.

[41] Pugsley MK. Challenging current paradigms in early drug development – innovative approaches to safety pharmacology. Available from: http://www.aptuit.com/Media/

Default/Verona/Symposium/Paradigms-2012/Presentations/Michael_Pugsley_

lecture_May16.pdf [accessed 09.12.2014].

[42] Tendering for public sector contracts. Available from: http://www.businesslink.gov.uk/

bdotg/action/layer?topicId=1074033478 [accessed 09.12.2014].

[43] ChemistryInnovation annual report 2011. Available from: https://connect.innovateuk.

org/web/case-studies [accessed 09.12.2014].

[44] BIOCHEM project. Available from: http://www.biochem-project.eu/ [accessed 09.12.2014].

[45] United Kingdom Parliament – Parliament UK. Available from: http://www.publications.

parliament.uk/pa/cm201012/cmselect/cmsctech/writev/valley/valley42.htm [accessed 09.12.2014].

[46] Henderson J. The role of corporate venture capital funds in financing biotechnology and healthcare: differing approaches and performance consequences. Available from: https://

www.imd.org/research/publications/upload/Henderson_WP_2007_02_Level_1.pdf [accessed 09.12.2014].

[47] Defense Advanced Projects Agency; 2012. Available from: http://www.darpa.mil [accessed 09.12.2014].

[48] Canadian Institutes of Health Research. Available from: http://www.cihr-irsc.gc.ca/e/193.

html [accessed 09.12.2014].

[49] Ontario Venture Capital Fund. Available from: http://www.ovcf.com/ [accessed 09.12.2014].

Social Aspects of Drug Discovery, Development and Commercialization 82

[50] Natural Sciences and Engineering Research Council of Canada. Available from: www.

nserc-crsng.gc.ca [accessed 09.12.2014].

[51] National Research Council Canada. Available from: www.nrc-cnrc.gc.ca [accessed 09.12.2014].

[52] Available from: http://www.ncats.nih.gov/research/rare-diseases/bridgs/bridgs.html [53] Genome Canada. Available from: www.genomecanada.ca [accessed 09.12.2014].

[54] National Centre for Advancing Translational Sciences (NCATS). Available from: www.

ncats.nih.gov [accessed 09.12.2014].

[55] Innovative Medicines Initiative (IMI). Available from: www.imi.europea.eu [accessed 09.12.2014].

[56] The Centre for Drug R&D (CDRD). Available from: www.cdrd.ca [accessed 09.12.2014].

[57] Inglese J, Auld DS, Jadhav A, Johnson RL, Simeonov A, Yasgar A, Zheng W, Austin CP.

Quantitative high-throughput screening: a titration-based approach that efficiently identifies biological activities in large chemical libraries. PNAS 2006;103(31):11473–8.

[58] Molecular Libraries Program. Available from: http://mli.nih.gov/mli/ [accessed 09.12.2014].

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