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 Karp; Andrew Price; Andrew Carr; David A Brindley

doi:10.1177/2041731414551764

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 journal › Review article › peer-review

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 language	English
Journal	Journal of Tissue Engineering
Volume	5
DOIs	https://doi.org/10.1177/2041731414551764
Publication status	Published - 22 Sept 2014

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., Judge, A., MacLaren, R. E., Mathur, A., Williams, D. J., Wall, I., Birchall, M., Reeve, B., Atala, A., Barker, R. W., Cui, Z., Furniss, D., Bure, K., Snyder, E. Y., ... 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

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

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. ",

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

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).",

year = "2014",

month = sep,

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doi = "10.1177/2041731414551764",

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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

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

SN - 2041-7314

VL - 5

JO - Journal of Tissue Engineering

JF - Journal of Tissue Engineering

ER -

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

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