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

Ginty, Patrick J. and Rayment, Erin A. and 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. ISSN 1746-0751

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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.

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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: © 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.
Faculty/School / Institute/Centre: No Faculty
Faculty/School / Institute/Centre: No Faculty
Date Deposited: 05 Nov 2014 06:33
Last Modified: 09 Feb 2017 03:11
Uncontrolled Keywords: adoption; cell therapy; good manufacturing practice; investment in medical devices; regenerative medicine; regulation; reimbursement; value proposition; venture capital
Fields of Research (2008): 15 Commerce, Management, Tourism and Services > 1505 Marketing > 150501 Consumer-Oriented Productor Service Development
15 Commerce, Management, Tourism and Services > 1503 Business and Management > 150307 Innovation and Technology Management
10 Technology > 1004 Medical Biotechnology > 100404 Regenerative Medicine (incl. Stem Cells and Tissue Engineering)
Fields of Research (2020): 35 COMMERCE, MANAGEMENT, TOURISM AND SERVICES > 3506 Marketing > 350602 Consumer-oriented product or service development
35 COMMERCE, MANAGEMENT, TOURISM AND SERVICES > 3599 Other commerce, management, tourism and services > 359999 Other commerce, management, tourism and services not elsewhere classified
32 BIOMEDICAL AND CLINICAL SCIENCES > 3206 Medical biotechnology > 320606 Regenerative medicine (incl. stem cells)
Socio-Economic Objectives (2008): B Economic Development > 86 Manufacturing > 8608 Human Pharmaceutical Products > 860899 Human Pharmaceutical Products not elsewhere classified
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