Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

Benjamin M Davies, Sarah Rikabi, Anna French, Rafael Pinedo-Villanueva, Mark E Morrey, Karolina Wartolowska, Andrew Judge, Robert E MacLaren, Anthony Mathur, David J Williams, Ivan Wall, Martin Birchall, Brock Reeve, Anthony Atala, Richard W Barker, Zhanfeng Cui, Dominic Furniss, Kim Bure, Evan Y Snyder, Jeffrey M KarpAndrew Price, Andrew Carr, David A Brindley

Research output: Contribution to journalReview article

Abstract

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

Original languageEnglish
JournalJournal of Tissue Engineering
Volume5
DOIs
Publication statusPublished - 22 Sep 2014

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Cost effectiveness
Cell- and Tissue-Based Therapy
Industry
Cost-Benefit Analysis
Therapeutics
Clinical Trials

Bibliographical note

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).

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Davies, B. M., Rikabi, S., French, A., Pinedo-Villanueva, R., Morrey, M. E., Wartolowska, K., ... Brindley, D. A. (2014). Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study. Journal of Tissue Engineering, 5. https://doi.org/10.1177/2041731414551764
Davies, Benjamin M ; Rikabi, Sarah ; French, Anna ; Pinedo-Villanueva, Rafael ; Morrey, Mark E ; Wartolowska, Karolina ; Judge, Andrew ; MacLaren, Robert E ; Mathur, Anthony ; Williams, David J ; Wall, Ivan ; Birchall, Martin ; Reeve, Brock ; Atala, Anthony ; Barker, Richard W ; Cui, Zhanfeng ; Furniss, Dominic ; Bure, Kim ; Snyder, Evan Y ; Karp, Jeffrey M ; Price, Andrew ; Carr, Andrew ; Brindley, David A. / Quantitative assessment of barriers to the clinical development and adoption of cellular therapies : A pilot study. In: Journal of Tissue Engineering. 2014 ; Vol. 5.
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abstract = "There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.",
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note = "This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).",
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Davies, BM, Rikabi, S, French, A, Pinedo-Villanueva, R, Morrey, ME, Wartolowska, K, Judge, A, MacLaren, RE, Mathur, A, Williams, DJ, Wall, I, Birchall, M, Reeve, B, Atala, A, Barker, RW, Cui, Z, Furniss, D, Bure, K, Snyder, EY, Karp, JM, Price, A, Carr, A & Brindley, DA 2014, 'Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study', Journal of Tissue Engineering, vol. 5. https://doi.org/10.1177/2041731414551764

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies : A pilot study. / Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A.

In: Journal of Tissue Engineering, Vol. 5, 22.09.2014.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Quantitative assessment of barriers to the clinical development and adoption of cellular therapies

T2 - A pilot study

AU - Davies, Benjamin M

AU - Rikabi, Sarah

AU - French, Anna

AU - Pinedo-Villanueva, Rafael

AU - Morrey, Mark E

AU - Wartolowska, Karolina

AU - Judge, Andrew

AU - MacLaren, Robert E

AU - Mathur, Anthony

AU - Williams, David J

AU - Wall, Ivan

AU - Birchall, Martin

AU - Reeve, Brock

AU - Atala, Anthony

AU - Barker, Richard W

AU - Cui, Zhanfeng

AU - Furniss, Dominic

AU - Bure, Kim

AU - Snyder, Evan Y

AU - Karp, Jeffrey M

AU - Price, Andrew

AU - Carr, Andrew

AU - Brindley, David A

N1 - This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).

PY - 2014/9/22

Y1 - 2014/9/22

N2 - There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

AB - There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

UR - https://journals.sagepub.com/doi/10.1177/2041731414551764

U2 - 10.1177/2041731414551764

DO - 10.1177/2041731414551764

M3 - Review article

C2 - 25383173

VL - 5

ER -

Davies BM, Rikabi S, French A, Pinedo-Villanueva R, Morrey ME, Wartolowska K et al. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study. Journal of Tissue Engineering. 2014 Sep 22;5. https://doi.org/10.1177/2041731414551764