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
Permalink -

https://research.usq.edu.au/item/q2v7q/regenerative-medicine-resource-and-regulation-lessons-learned-from-the-remedi-project

Download files


Published Version
  • 1735
    total views
  • 232
    total downloads
  • 0
    views this month
  • 0
    downloads this month

Export as

Related outputs

Pleasant encounters of the VM kind: leveraging on NeCTAR VMs to achieve research outcomes
Gacenga, Francis, Kelly, Nick and Rayment, Erin. 2014. "Pleasant encounters of the VM kind: leveraging on NeCTAR VMs to achieve research outcomes." eResearch Australasia 2014 Conference: Towards Unified Global Research. Melbourne, Australia 27 - 31 Oct 2014 Sydney, Australia.
Attenuation of protease activity in chronic wound fluid with bisphosphonate-functionalised hydrogels
Rayment, Erin A., Dargaville, Tim R., Shooter, Gary K., George, Graeme A. and Upton, Zee. 2008. "Attenuation of protease activity in chronic wound fluid with bisphosphonate-functionalised hydrogels." Biomaterials. 29 (12), pp. 1785-1795. https://doi.org/10.1016/j.biomaterials.2007.12.043
Increased matrix metalloproteinase-9 (MMP-9) activity observed in chronic wound fluid is related to the clinical severity of the ulcer
Rayment, E. A., Upton, Z. and Shooter, G. K.. 2008. "Increased matrix metalloproteinase-9 (MMP-9) activity observed in chronic wound fluid is related to the clinical severity of the ulcer." British Journal of Dermatology. 158 (5), pp. 951-961. https://doi.org/10.1111/j.1365-2133.2008.08462.x
Review: finding the culprit: a review of the influences of proteases on the chronic wound environment
Rayment, Erin A. and Upton, Zee. 2009. "Review: finding the culprit: a review of the influences of proteases on the chronic wound environment." International Journal of Lower Extremity Wounds. 8 (1), pp. 19-27. https://doi.org/10.1177/1534734609331596
Concise review: mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation
Rayment, Erin A. and Williams, David J.. 2010. "Concise review: mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation." Stem Cells. 28 (5), pp. 996-1004. https://doi.org/10.1002/stem.416
Human pilot studies reveal the potential of a vitronectin: growth factor complex as a treatment for chronic wounds
Upton, Zee, Wallace, Hilary J., Shooter, Gary K., van Lonkhuyzen, Derek R., Yeoh-Ellerton, Sim, Rayment, Erin A., Fleming, Jacqui M., Broszczak, Daniel, Queen, Douglas, Sibbald, R. Gary, Leavesley, David I. and Stacey, Michael C.. 2011. "Human pilot studies reveal the potential of a vitronectin: growth factor complex as a treatment for chronic wounds." International Wound Journal. 8 (5), pp. 522-532. https://doi.org/10.1111/j.1742-481X.2011.00859.x
Precision manufacturing for clinical-quality regenerative medicines
Williams, David J., Thomas, Robert J., Hourd, Paul C., Chandra, Amit, Ratcliffe, Elizabeth, Liu, Yang, Rayment, Erin A. and Archer, J. Richard. 2012. "Precision manufacturing for clinical-quality regenerative medicines." Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences. 370 (1973), pp. 3924-3949. https://doi.org/10.1098/rsta.2011.0049
Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
Ratcliffe, Elizabeth, Hourd, Paul, Guijarro-Leach, Juan, Rayment, Erin, Williams, David J. and Thomas, Robert J.. 2013. "Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture." Regenerative Medicine. 8 (1), pp. 39-48. https://doi.org/10.2217/rme.12.109