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Review
. 2014 Sep 19;5:2041731414551764.
doi: 10.1177/2041731414551764. eCollection 2014.

Quantitative Assessment of Barriers to the Clinical Development and Adoption of Cellular Therapies: A Pilot Study

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Free PMC article
Review

Quantitative Assessment of Barriers to the Clinical Development and Adoption of Cellular Therapies: A Pilot Study

Benjamin M Davies et al. J Tissue Eng. .
Free PMC 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.

Keywords: Cell- and tissue-based therapy; regenerative medicine; stem cells; tissue engineering; translational medical research.

Conflict of interest statement

Declaration of conflicting interests: We would like to make the following declarations regarding conflicts of interest:

B.R. is a stockholder in Pathfinder Cell Therapy (MA, USA). R.W.B. is an independent director and/or stockholder in Celgene (NJ, USA). K.B. is an employee and/or stockholder in Sartorius Stedim (Göttingen, Germany). J.M.K. was supported by National Institutes of Health grant HL095722, Department of Defense grant W81XWH-13-1-0305, and by a Movember-Prostate Cancer Foundation Challenge. The content outlined herein represents the individual opinions of the authors and may not necessarily represent the viewpoints of their employers. D.A.B. gratefully acknowledges the support from the SENS Research Foundation (Mountain View, CA, USA). D.A.B. is a stockholder in Translation Ventures Ltd. (Charlbury, Oxfordshire, UK), a company that among other services provides cell therapy biomanufacturing, regulatory, and financial advice to clients in the cell therapy sector. D.A.B. is subject to the CFA Institute’s Codes, Standards, and Guidelines, and as such, this author must stress that this piece is provided for academic interest only and must not be construed in any way as an investment recommendation. Additionally, at the time of publication, D.A.B. and the organizations with which he is affiliated may or may not have agreed and/or pending funding commitments from the organizations named herein. D.A.B. has also conducted paid consultancy for Lonza Group and Sartorius Stedim within the past 7 years with a cumulative value of greater than US$10,000. All the other authors do not declare any additional conflicts of interest, as defined by the journal. However, the authors are happy to respond to direct requests for confirmation and stress that affiliations stated may or may not constitute a disclosure of employment and/or ownership of financial instruments in the named entity.

Figures

Figure 1.
Figure 1.
Survey participant knowledge and extent of familiarity with cell therapy products.
Figure 2.
Figure 2.
Perceived barriers to clinical development and adoption as identified through pilot questionnaire. Responses are presented as the mean for the whole group and then variation in each speciality’s mean response from the group mean. A higher score represents a greater perceived barrier.
Figure 3.
Figure 3.
Heat map of mean response data to perceived barriers by clinical speciality. Data are presented as the mean response from the polled clinicians.
Figure 4.
Figure 4.
Frequency with which each barrier appears in highest or lowest three perceived barriers (ordered as per “All Experts” mean ranking).

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