Developing innovation governance readiness in regenerative medicine: lessons learned from the Macchiarini crisis

Maureen Mckelvey, Rögnvaldur J. Saemundsson*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

The generation and clinical adoption of workable therapies in regenerative medicine has been slow, despite its alleged potential to relieve suffering and improve health outcomes. This has been explained by a fundamental difference between advanced cell and gene therapies and conventional drug- and device-based therapies, raising questions about how the readiness of existing healthcare systems to adopt such therapies can be evaluated and improved. In this paper, we use the lessons learned from the Macchiarini crisis at the Karolinska Institute in Sweden to take the first step in formulating the concept of innovation governance readiness. We propose it as a tool to help evaluate and improve the ability of private, public and civil society actors to work together to build and put into practice therapies based on emerging medical technologies such as regenerative medicine.

Original languageEnglish
Pages (from-to)283-294
Number of pages12
JournalRegenerative Medicine
Volume16
Issue number3
DOIs
Publication statusPublished - Mar 2021

Bibliographical note

Funding Information:
This research was funded by the Swedish Research Council Distinguished Professor’s Programme, awarded to Professor M. McK-elvey. Research Programme: Knowledge-intensive Entrepreneurial Ecosystems: Transforming society through knowledge, innovation and entrepreneurship, VR DNR 2017–03360. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Publisher Copyright:
© 2021 Future Medicine Ltd.

Other keywords

  • innovation governance
  • innovation governance readiness
  • regenerative medicine

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