Regenerative medicine, resource and regulation: lessons learned from the remedi project

Article


Ginty, Patrick J., Rayment, Erin A., Hourd, Paul and Williams, David J.. 2011. "Regenerative medicine, resource and regulation: lessons learned from the remedi project." Regenerative Medicine. 6 (2), pp. 241-253. https://doi.org/10.2217/rme.10.89
Article Title

Regenerative medicine, resource and regulation: lessons learned from the remedi project

ERA Journal ID201443
Article CategoryArticle
AuthorsGinty, Patrick J. (Author), Rayment, Erin A. (Author), Hourd, Paul (Author) and Williams, David J. (Author)
Journal TitleRegenerative Medicine
Journal Citation6 (2), pp. 241-253
Number of Pages13
Year2011
Place of PublicationLondon, United Kingdom
ISSN1746-0751
1746-076X
Digital Object Identifier (DOI)https://doi.org/10.2217/rme.10.89
Web Address (URL)https://dspace.lboro.ac.uk/dspace-jspui/bitstream/2134/13379/3/Ginty%20et%20al%202011.pdf
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.

Keywordsadoption; cell therapy; good manufacturing practice; investment in medical devices; regenerative medicine; regulation; reimbursement; value proposition; venture capital
ANZSRC Field of Research 2020350602. Consumer-oriented product or service development
359999. Other commerce, management, tourism and services not elsewhere classified
320606. Regenerative medicine (incl. stem cells)
Public Notes

© 2011 Future Medicine Ltd. This publication is copyright. It may be reproduced in whole or in part for the purposes of study, research, or review, but is subject to the inclusion of an acknowledgment of the source.

Byline AffiliationsLoughborough University, United Kingdom
Institution of OriginUniversity of Southern Queensland
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