Regenerative medicine and responsible research and innovation: proposals for a responsible acceleration to the clinic

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

• 1 Kemp P. Regenerative medicine: looking backward 10 years further on. Regen. Med. 11(8), 787–800 (2016).
  CASGoogle Scholar
• 2 Mason C, Dunnill P. A brief definition of regenerative medicine. Regen. Med. 3(1), 1–5 (2008).
  Google Scholar
• 3 Ali R, Hollander A, Kemp P, Webster A, Wilkins M. Regulating cell-based regenerative medicine: the challenges ahead. Regen. Med. 9(1), 77–83 (2014).
  Google Scholar
• 4 Petersen A, Munsie M, Tanner C, MacGregor C, Brophy J. Stem Cell Tourism: The Political Economy of Hope. Palgrave Macmillan, Basingstoke, UK (2017).
  Google Scholar
• 5 Burningham S, Ollenberger A, Caulfield T. Commercialization and stem cell research: a review of emerging issues. Stem Cells Dev. 22(Suppl. 1), 80–84 (2013).
  MedlineGoogle Scholar
• 6 McLean A, Stewart C, Kerridge I. The emergence and popularisation of autologous somatic cellular therapies: therapeutic innovation or regulatory failure? J. Law. Med. 22(1), 65–89 (2014).
  MedlineGoogle Scholar
• 7 Isasi R, Knoppers BM, Andrews PW et al. Disclosure and management of research findings in stem cell research and banking: policy statement. Regen. Med. 7(3), 439–448 (2012).
  CASGoogle Scholar
• 8 Salter B, Zhou Y, Datta S. Governing new global health-care markets: the case of stem cell treatments. New Pol. Econ. 22(1), 76–91 (2017).
  Google Scholar
• 9 Webster A. Health, Technology and Society: A Sociological Critique. Palgrave Macmillan, Basingstoke, UK (2007).
  Google Scholar
• 10 Pickersgill M, Niewöhner J, Müller R et al. Mapping the new molecular landscape: social dimensions of epigenetics. New Genet. Soc. 32(4), 429–447 (2013).
  MedlineGoogle Scholar
• 11 Calvert J. Systems biology, big science and grand challenges. BioSocieties 8(4), 466–479 (2013).
  Google Scholar
• 12 House of Lords’ Science and Technology Committee. Regenerative Medicine Inquiry Report (2013). https://publications.parliament.uk/pa/ld201314/ldselect/ldsctech/23/23.pdf.
  Google Scholar
• 13 Regenerative Medicine Expert Group: building on our own potential: a UK pathway for regenerative medicine (2014). www.sehta.co.uk/wp-content/uploads/2015/06/Regenerative-Medicine-Expert-Group-Report.pdf.
  Google Scholar
• 14 House of Commons Science and Technology Committee. Regenerative Medicine Inquiry Report (2017). https://publications.parliament.uk/pa/cm201617/cmselect/cmsctech/275/275.pdf. • The most recent UK government report and recommendations relating to the regenerative medicine field.
  Google Scholar
• 15 Robinson D. Co-evolutionary scenarios: an application to prospecting futures of the responsible development of nanotechnology. Technol. Forecast. Soc. Change 76(9), 1222–1239 (2009).
  Google Scholar
• 16 von Schomberg R. European Commission Services. Towards responsible research and innovation in the ICT and security technology fields (2011). www.cse.dmu.ac.uk/∼bstahl/index_html_files/2011.3647_mep.pdf.
  Google Scholar
• 17 Rip A. The clothes of the emperor: an essay on RRI in and around Brussels. J. Resp. Innov. 3(3), 290–304 (2016).
  Google Scholar
• 18 Engineering and Physical Sciences Research Council (EPSR). Synbio Programme. www.epsrc.ac.uk/skills/students/centres/2013cdtexercise/priorityareas/synbiology/.
  Google Scholar
• 19 Commonwealth Scientific and Industrial Research Organisation (CSIRO). Future technologies programme on synthetic biology (2017). www.csiro.au/en/Research/LWF/Areas/Synthetic-Biology.
  Google Scholar
• 20 Davies S, Horst M. Responsible innovation in the US, UK and Denmark: governance landscapes. In: Responsible Innovation 2. Koops BJ (Ed.). Springer International Publishing, NY, USA, 37–56 (2015).
  Google Scholar
• 21 Monteiro T, Macnagthen P. Towards a framework of responsible research and innovation in Brazil. Presented at: American Association for the Advancement of Science Annual Meeting. IL, USA (13–17 February 2014). •• The key paper that develops the concept of responsible research and innovation most completely.
  Google Scholar
• 22 Royal Society. Nanoscience and nanotechnologies: opportunities and uncertainties. A joint report with the Royal Academy of Engineering (2004).
  Google Scholar
• 23 Rip A, te Kulve H. Constructive technology assessment and sociotechnical scenarios. In: Presenting Futures, Part of the Yearbook of Nanotechnology in Society (Volume 1). Fisher E, Selin C, Wetmore JM (Eds). Springer, Amsterdam, The Netherlands, 49–70 (2008).
  Google Scholar
• 24 Barry A. Political Machines: Governing a Technological Society. Athlone Press, London, UK (2001).
  Google Scholar
• 25 Rathenau Institute. Rathenau Instituut 2017–2018 Work Programme (2017). www.rathenau.nl/en/publication/work-programme-2017--2018.
  Google Scholar
• 26 Palmer TN, Hardaker P. Handling uncertainty in science. Phil. Trans. R. Soc. A. 369(1956), 4681–4684 (2011).
  CASGoogle Scholar
• 27 Birch K. Rethinking value in the bio-economy: finance, assetization and the management of value. Sci. Technol. Human Values 42(3), 460–490 (2017).
  MedlineGoogle Scholar
• 28 Mittra J. The New Health Bioeconomy: R&D Policy Innovation for the Twenty-first Century. Palgrave Macmillan, Basingstoke, UK (2016).
  Google Scholar
• 29 Mazzucato M. The Entrepreneurial State. Anthem Press, London, UK (2013).
  Google Scholar
• 30 de Saille S, Medvecky F. Innovation for a steady state: a case for responsible stagnation. Econ. Soc. 45(1), 1–23 (2016). •• A social science perspective on innovation that provides a critique of accelerated development and growth.
  Google Scholar
• 31 Stilgoe J, Owen R, Macnaghten P. Developing a framework for responsible innovation. Res. Policy 42(9), 1568–1580 (2013).
  Google Scholar
• 32 Owen R, Stilgoe J, Macnaghten P et al. A framework for responsible innovation. In: Responsible Innovation. Owen R, Bessant J, Heintz M (Eds). John Wiley & Sons, London, UK (2013).
  Google Scholar
• 33 Demers-Payette O, Lehoux P, Daudelin D. Responsible research and innovation: a productive model for the future of medical innovation. J. Resp. Innov. 3(3), 188–208 (2016).
  Google Scholar
• 34 A valuable overview of how RRI can apply to health systems more broadly. In: The New Production of Users: Changing Innovation Collectives and Involvement Strategies (Riot! Routledge Studies in Innovation, Organization and Technology). Hyysalo S, Jensen TE, Oudshoorn N (Eds). Routledge, London, UK (2016).
  Google Scholar
• 35 Callon M. An essay on the growing contribution of economic markets to the proliferation of the social. Theor. Cult. Soc. 24(7–8), 139–163 (2007).
  Google Scholar
• 36 Gardner J, Webster A. The social management of biomedical novelty: facilitating translation in regenerative medicine. Soc. Sci. Med. 156, 90–97 (2016). •• Provides a detailed examination of the regenerative medicine field, its novelty and responses to this.
  MedlineGoogle Scholar
• 37 May CR, Johnson M, Finch T. Implementation, context and complexity. Implement Sci. 11, 141 (2016). • Helps make sense of the ways in which adoption of new technology actually happens.
  MedlineGoogle Scholar
• 38 Australian Academy of Science. The Stem Cell Revolution: Lessons and Imperatives for Australia (2015). www.science.org.au/files/userfiles/events/documents/think-tank-2015-recommendations.pdf.
  Google Scholar
• 39 Cell and Gene Therapy Catapult. The UK landscape for regenerative medicine (2016). www.york.ac.uk/media/satsu/news-docs-images/RMEG-report-2016.pdf.
  Google Scholar
• 40 Gardner J, Faulkner A, Mahalatchimy A, Webster A. Are there specific translational challenges in regenerative medicine? Lessons from other fields. Regen. Med. 10(7), 885–895 (2015).
  CASGoogle Scholar
• 41 Medcalfe N. Business models for manufacture of cellular therapies. In: Stem Cell Manufacturing. Cabral JM, de Silva CL, Chase LG, Diogo MM (Eds). Elsevier, Amsterdam, The Netherlands, 265–290 (2016). • Explores different models relating to the production and scale-up of cell therapies which is one of the key challenges associated with future institutional readiness.
  Google Scholar
• 42 Star SL. Ethnography of infrastructure. Am. Behav. Sci. 43(3), 377–391 (1999).
  Google Scholar
• 43 GOV.co.uk. Accelerated access review: final report. Review of innovative medicines and medical technologies (2016). www.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf.
  Google Scholar
• 44 Nowotny H. Democratising expertise and socially robust knowledge. Sci. Public Policy 30(3), 151–156 (2003).
  Google Scholar
• 45 Isasi R, Rahimzadeh V, Charlebois K. Uncertainty and innovation: understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environment. Appl. Transl. Genom. 11, 27–39 (2016).
  MedlineGoogle Scholar
• 46 Ginty PJ, Rayment EA, Hourd P et al. Regenerative medicine, resource and regulation: lessons learned from the remedi project. Regen. Med. 6(2), 241–253 (2011).
  Google Scholar
• 47 Higham R. Clinical trials and the challenge of regenerative medicine: do we need a new approach for cell therapy trials? Presented at: Final Conference of the ESRC REGenableMED project. Kings College London, London, UK (23 May 2017).
  Google Scholar
• 48 Keating A. Mesenchymal stroma cells: new directions. Cell Stem Cell 10(6), 709–716 (2012).
  Medline CASGoogle Scholar
• 49 Greenhalgh T, Howick J, Maskrey N. Evidence-based medicine: a movement in crisis? BMJ 348, g3725 (2014).
  MedlineGoogle Scholar
• 50 Critical Path Institute. Annual Report (2015). https://c-path.org/wp-content/uploads/2013/05/annualreport2015_FINAL.pdf.
  Google Scholar
• 51 Faulkner A. Opening the gateways to market and adoption of regenerative medicine? The UK case in context. Regen. Med. 11(3), 321–330 (2016). • Offers a detailed assessment of shifting regulatory pathways for regenerative medicine and the impact that they will have.
  CASGoogle Scholar
• 52 Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu. Rev. Med. 59, 1–12 (2008).
  Medline CASGoogle Scholar
• 53 Boon WPC, Moors EHM, Meijer A et al. Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe. Clin. Pharm. Ther. 88(6), 848–853 (2010).
  Medline CASGoogle Scholar
• 54 Lowdell M, Thomas A. The expanding role of the clinical haematologists in the new world of advanced therapy medicine products. Br. J. Haematol. 176(1), 9–15 (2017). •• A key paper on the organizational and professional parameters that will shape future advanced therapy centers in hospital settings.
  MedlineGoogle Scholar
• 55 Mol A-M, Law J. Complexities: an introduction. In: Complexities: Social Studies of Knowledge Practices. Mol A-M, Law J (Eds). Duke University Press, NC, USA, 1–22 (2002).
  Google Scholar
• 56 Woodward E. Slowing the pace of technological change? J. Resp. Innov. 3(3), 266–273 (2016).
  Google Scholar
• 57 Medicine Manufacturing Industry Partnership. Advanced therapies manufacturing action plan. Retaining and attracting advanced therapies manufacture in the UK (2016). www.abpi.org.uk/our-work/mmip/Documents/Advanced-Therapies-Manufacturing-Taskforce-report.pdf. •• Examines UK-based capacity and opportunity for commercial activity in the field.
  Google Scholar