Literature DB >> 26541074

Are there specific translational challenges in regenerative medicine? Lessons from other fields.

John Gardner1, Alex Faulkner2, Aurélie Mahalatchimy3, Andrew Webster1.   

Abstract

There is concern that translation 'from bench to bedside' within regenerative medicine (RM) will fail to materialize, or will be dismally slow, due to various challenges arising from the highly novel and disruptive nature of RM. In this article, we provide a summary of these challenges, and we critically engage with the notion that such challenges are specific to RM. It is important, we argue, not to overstate the exceptional nature of RM, as valuable lessons can be learned from elsewhere in medicine. Using several examples of technology adoption, we suggest that emerging RM products and procedures will have to work hard to find or create an adoption space if translation into the clinic is to be successful.

Keywords:  adoption space; clinical trials; manufacturing; regulation; reimbursement; technology adoption; translational challenges; translational medicine

Mesh:

Year:  2015        PMID: 26541074     DOI: 10.2217/rme.15.50

Source DB:  PubMed          Journal:  Regen Med        ISSN: 1746-0751            Impact factor:   3.806


  8 in total

1.  Accelerating Innovation in the Creation of Biovalue: The Cell and Gene Therapy Catapult.

Authors:  John Gardner; Andrew Webster
Journal:  Sci Technol Human Values       Date:  2017-04-06

Review 2.  Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients.

Authors:  Magdalini Papadaki
Journal:  Front Med (Lausanne)       Date:  2017-05-29

3.  Innovative regenerative medicines in the EU: a better future in evidence?

Authors:  Mark S Corbett; Andrew Webster; Robert Hawkins; Nerys Woolacott
Journal:  BMC Med       Date:  2017-03-08       Impact factor: 8.775

Review 4.  The Progression of Regenerative Medicine and its Impact on Therapy Translation.

Authors:  Erik Jacques; Erik J Suuronen
Journal:  Clin Transl Sci       Date:  2020-02-06       Impact factor: 4.689

5.  Perspectives on human regeneration.

Authors:  James F Stark
Journal:  Palgrave Commun       Date:  2018-06-12

6.  Accelerating Innovation: Complexity, Regulation, and Temporality.

Authors:  Andrew Webster
Journal:  Front Sociol       Date:  2019-03-12

7.  Evaluating different adoption scenarios for TIL-therapy and the influence on its (early) cost-effectiveness.

Authors:  Melanie Lindenberg; Valesca Retèl; Maartje Rohaan; Joost van den Berg; John Haanen; Wim van Harten
Journal:  BMC Cancer       Date:  2020-07-31       Impact factor: 4.430

8.  Treatment With Tumor-infiltrating Lymphocytes in Advanced Melanoma: Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product.

Authors:  Melanie A Lindenberg; Valesca P Retèl; Joost H van den Berg; Marnix H Geukes Foppen; John B Haanen; Wim H van Harten
Journal:  J Immunother       Date:  2018 Nov/Dec       Impact factor: 4.456

  8 in total

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