Abstract
Numerous claims have been made regarding the potential benefits that regenerative medicine will bring to clinical practice. However, robust data on what is happening in the field is difficult to secure. In this chapter we examine that data we have found to have a sufficient degree of accuracy in terms of global trends in three domains: corporate activity and interests; the sponsorship of clinical trials (CTs); and recent patent activity by firms and other organisations such as academic institutions and other ‘not-for-profit’ bodies. Such data is of interest in its own right because the domains chosen for investigation are important indicators of both the strength and the location (or ‘geographical shape’) of innovation in this emerging field. In addition, by focusing on these three domains the chapter contextualises the themes discussed and analysed in the chapters that follow.
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References
Aldridge, S. (2010) Regenerative medicine: small steps towards the great leap forward, InPharm (16 August). Available at http://www.inpharm.com/news/regenerative-medicine-small-steps-towards-great-leap-forward
Appelbaum, F. R. (2007) Hematopoietic-Cell Transplantation at 50, New England Journal of Medicine, 357: 1472–1475.
Bergman, K. and G. Graff (2007a) The global stem cell patent landscape: implications for efficient technology transfer and commercial development, Nature Biotechnology, 25(4): 419–424.
Bergman, K. and G. Graff (2007b) Collaborative IP Management for Stem Cell Research and Development, Davis, CA: Centre for Intellectual Property Studies (CIP), Göteborg and Public Intellectual Property Resource for Agriculture (PIPRA).
BIS (2011) Taking Stock of Regenerative Medicine in the United Kingdom, (July). UK Department of Business, Innovation and Skills (BIS) and UK Department of Health. Available at http://www.bis.gov.uk/assets/biscore/innovation/docs/t/11–1056-taking-stock-of-regenerative-medicine
Blackburn-Starza, A. (2011) Ban on embryonic stem cell patents by European Court of Justice, BioNews, 630(24 October). Available at http://www.bionews.org.uk/page_109818.asp
Boseley, S. (2011) Geron abandons stem cell therapy as treatment for paralysis, The Guardian (15 November). Available at http://www.guardian.co.uk/science/2011/nov/15/geron-abandons-stem-cell-therapy
Brown, N. (2003) Hope against hype — accountability in biopasts, presents and futures, Science Studies, 16(2): 3–21.
Brown, N. and M. Michael (2003) A sociology of expectations: retrospecting prospects and prospecting retrospects, Technology Analysis and Strategic Management, 15(1): 3–18.
Clancey, G. (2012) Intelligent island to biopolis: smart minds, sick bodies and millennial turns in Singapore, Science, Technology and Society, 17(1): 13–35.
Committee for Advanced Therapies and CAT Scientific Secretariat (2010) Use of unregulated stem-cell based medicinal products, The Lancet, 376 (14 August): 514.
Crunkhorn, S. (2012) Deal watch: shire increases focus on regenerative medicine, Nature Reviews Drug Discovery, 11: 430.
Cyranoski, D. (2012a) China’s stem-cell rules go unheeded, Nature, 484: 149–150.
Cyranoski, D. (2012b) Stem-cell therapy takes off in Texas, Nature, 483(1 March): 13–14.
Daar, A. S. and H. L. Greenwood (2007) A proposed definition of regenerative medicine, Journal of Tissue Engineering and Regenerative Medicine, 1(3): 179–84.
Datamonitor (2010) Pharmaceutical key trends 2010 — the patent cliff dominates but growth opportunities remain, DataMonitor 259(17 March).
Deuten, J. J. and A. Rip (2000) Narrative infrastructure in product creation processes, Organization, 7(1): 69–83.
Dolgin, E. (2010) Survey details stem cell clinics ahead of regulatory approval, Nature Medicine, 16(5): 495.
Dunoon, A. and V. Vollebregt (2010) Can regenerative medicine save Big Pharma business model from the patent cliff?, Regenerative Medicine, 5(5): 687–690.
Dutton, G. (2012) Stem cell applications hasten into the clinic, Genetic Technology and Biotechnology News, 32(2) (January 15): 1–2.
European Court of Justice (2011a) A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. Press Release No 112/11, Luxembourg, 18 October 2011. Judgment in Case C-34/10 Oliver Brüstle v Greenpeace e.V. Available at http://curia.europa.eu/jcms/upload/docs/ application/pdf/2011–10/cp110112en.pdf
European Court of Justice (2011b) Judgment of the Court (Grand Chamber) of 18 October 2011. Oliver Brüstle v Greenpeace e V. Reference for a preliminary ruling: Bundesgerichtshof — Germany. Directive 98/44/EC — Article 6(2)(c) — Legal protection of biotechnological inventions. Available at http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10
Friedman, Y. (2010) Location of pharmaceutical innovation: 2000–2009, Nature Reviews Drug Discovery, 9: 835.
Ginty, P. J., E. A. Rayment, P. Hourd, and D. J. Williams (2011) Regenerative medicine, resource and regulation: lessons learned from the remedi project, Regenerative Medicine, 6(2): 241–253.
Haseltine, W. A. (2001) The emergence of regenerative medicine: a new field and a new society, The Journal of Regenerative Medicine, 2: 17–23.
Hogarth, S. and B. Salter (2010) Regenerative medicine in Europe: global competition and innovation governance, Regenerative Medicine, 5(6): 971–985.
Hopkins, M., S. Mahdi, S. M. Thomas and P. Patel (2006) The Patenting of Human DNA: Global Trends in Public and Private Sector Activity (The PATGEN Project). Sussex: Science and Technology Policy Research Unit (SPRU).
Kemp, P. (2006) History of regenerative medicine: looking backwards to move forwards, Regenerative Medicine, 1(5): 653–669.
Light, D. W. (2009) Global drug discovery: Europe is ahead, Health Affairs, 28: 969–977.
Lindvall, O. and I. Hyun (2009) Medical Innovation Versus Stem Cell Tourism, Science 324(5935): 1664–1665.
Lysaght, M. J., A. Jaklenec and E. Deweerd (2008) Great expectations: private sector activity in tissue engineering, regenerative medicine, and stem cell therapeutics, Tissue Engineering: Part A, 14(2): 305–315.
Martin, P. et al. (2006) Commercial development of stem cell technology: lessons from the past, strategies for the future, Regenerative Medicine, 1(6): 801–807.
Martin, P. et al. (2008) Capitalizing hope: the commercial development of umbilical cord blood stem cell banking, New Genetics and Society, 27(2): 127–143.
Martino, M. (2010) Gene therapy rises from the dead, FierceBiotech (23 April). Available at www.fiercebiotech.com/story/gene-therapy-rises-dead/2010–04–23?utm medium=nl&utm source=internal#ixzz1HRiAK3EG
Mason, C. (2007) Regenerative medicine 2.0, Regenerative Medicine, 2(1): 11–18.
Mason, C. and P. Dunnill (2008a) The strong financial case for regenerative medicine and the regen industry, Regenerative Medicine, 3(3): 351–363.
Mason, C. and P. Dunnill (2008b) A brief definition of regenerative medicine, Regenerative Medicine, 3(1): 1–5.
McCann, S. R. (2003) The history of bone marrow transplantation, in N. S. Hakim and V. E. Papalois (eds) Organ and Cell Transplantation. London: Imperial College Press.
McKernan, R. et al. (2010) Pharma’s developing interest in stem cells, Cell Stem Cell, 6: 517–520.
Melnikova, I. (2012) Rare diseases and orphan drugs, Nature Reviews Drug Discovery, 11: 267–268.
Morrison, M. (2012) Promissory futures and possible pasts: the dynamics of contemporary expectations in regenerative medicine, BioSocieties, 7: 3–22.
MRC (2012) A Strategy for UK Regenerative Medicine. Document prepared by the UK Medical Research Council (MRC) in partnership with the BBSRC, EPSRC, ESRC and the Technology Strategy Board (TSB) (April).
Neish, J. (2007) Stem cells as screening tools in drug discovery, Current Opinion in Pharmacology, 7(5): 515–520.
Nelson, J. (1998) Analysis of patenting within gene therapy, Expert Opinion on Therapeutic Patents, 8(11): 1495–1505.
Oldham, P. and A.M. Cutter (2006) Mapping global status and trends in patent activity for biological and genetic material, Genomics, Society and Policy, 2(2): 62–91.
Philippidis, A. (2011) Orphan drugs, big pharma, Human Genetics Therapy, 22: 1037–1040.
Plagnol, A. C., E. Rowley, P. Martin and F. Livesey (2009) Industry perceptions of barriers to commercialization of regenerative medicine products in the UK, Regenerative Medicine, 4(4): 549–559.
Reiss, T. and E. Strauss (1998) Gene therapy — the dynamics of patenting worldwide, Expert Opinion on Therapeutic Patents, 8(2): 173–179.
Ryan, K. A. et al. (2010) Tracking the rise of stem cell tourism, Regenerative Medicine, 5: 27–33.
Suarez-Villa, L. (2000) Invention and the Rise of Technocapitalism. Boston, MAUS and Oxford, UK: Rowman & Littlefield.
Takahashi, K. et al. (2001) Induction of pluripotent stem cells from adult human fibroblasts by defined factors, Cell, 131(5): 861–872.
Thomson, J. A. et al. (1998) Embryonic stem cell lines derived from human blastocysts, Science, 282: 1145–1147.
US Department of Commerce (2010) US Patent and Trademark Office. Manual of Patent Examining Procedure. Virginia: US Patent and Trademark Office.
Wainwright, S. et al. (2008) Shifting paradigms? Reflections on regenerative medicine, embryonic stem cells and pharmaceuticals, Sociology of Health and Illness, 30(6): 959–974.
Waters, R (2010) Gene Therapy revival spurs hope for Genzyme, Pfizer, Bloomberg Business Week (26 April). http://www.bloomberg.com/news/2010–04–22/-dead-as-doornail-gene-therapy-revival-spurs-hope-for-genzyme-pfizer.html
Webster, A. (2013) Introduction: the boundaries and mobilities of regenerative medicine, in A. Webster (ed) The Global Dynamics of Regenerative Medicine: A Social Science Critique. Basingstoke: Palgrave Macmillan.
Webster, A. et al. (2011) Regenerative medicine in Europe: emerging needs and challenges in a global context (REMEDiE), Final Report to the European Cornmission, SATSU, University of York. Available at http://www.york.ac.uk/satsu/remedie.reports
Whitaker, M. and L. Foley (2011) What are the challenges of bringing RM to the clinic? Paper presented at 3rd REMEDiE conference, Bilbao, Spain, 10 April. Available at http://www.york.ac.uk/satsu/remedie
Yamanaka, S. (2009) A fresh look at iPS cells, Cell, 137(April 3): 13–17.
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© 2013 Graham Lewis
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Lewis, G. (2013). Regenerative Medicine at a Global Level: Current Patterns and Global Trends. In: Webster, A. (eds) The Global Dynamics of Regenerative Medicine. Health, Technology and Society. Palgrave Macmillan, London. https://doi.org/10.1057/9781137026552_2
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DOI: https://doi.org/10.1057/9781137026552_2
Publisher Name: Palgrave Macmillan, London
Print ISBN: 978-1-349-43924-9
Online ISBN: 978-1-137-02655-2
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