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Please use this identifier to cite or link to this item: https://dspace.lboro.ac.uk/2134/13379

Title: Regenerative medicine, resource and regulation: lessons learned from the remedi project
Authors: Ginty, Patrick J.
Rayment, Erin
Hourd, Paul C.
Williams, David J.
Keywords: Adoption
Cell therapy
Good manufacturing practice
Investment
Medical devices
Regenerative medicine
Regulation
Reimbursement
Value proposition
Venture capital
Issue Date: 2011
Publisher: © Future Medicine Ltd
Citation: GINTY, P.J. ... et al., 2011. Regenerative medicine, resource and regulation: lessons learned from the remedi project. Regenerative Medicine, 6 (2), pp. 241 - 253.
Abstract: The successful commercialization of regenerative medicine products provides a unique challenge to the manufacturer owing to a lack of suitable investment/business models and a constantly evolving regulatory framework. The resultant slow translation of scientific discovery into safe and clinically efficacious therapies is preventing many potential products from reaching the market. This is despite of the need for new therapies that may reduce the burden on the world’s healthcare systems and address the desperate need for replacement tissues and organs. The collaborative Engineering and Physical Sciences Research Council (EPSRC)-funded remedi project was devised to take a holistic but manufacturing-led approach to the challenge of translational regenerative medicine in the UK. Through strategic collaborations and discussions with industry and other academic partners, many of the positive and negative issues surrounding business and regulatory success have been documented to provide a remedi-led perspective on the management of risk in business and the elucidation of the regulatory pathways, and how the two are inherently linked. This article represents the findings from these discussions with key stakeholders and the research into best business and regulatory practices.
Description: This article was published in the journal, Regenerative Medicine [© Future Medicine Ltd] and the definitive version is available at: http://dx.doi.org/10.2217/rme.10.89
Sponsor: EPSRC
Version: Accepted for publication
DOI: 10.2217/RME.10.89
URI: https://dspace.lboro.ac.uk/2134/13379
Publisher Link: http://dx.doi.org/10.2217/RME.10.89
ISSN: 1746-0751
Appears in Collections:Published Articles (Mechanical, Electrical and Manufacturing Engineering)

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