Challenges in the
translation and commercialization of cell therapies
- *Corresponding
author: Aaron D Levineaaron.levine@pubpolicy.gatech.edu
1School of Public Policy, Georgia Institute of
Technology, Atlanta, GA, USA
2School of Public Policy, Parker H. Petit
Institute for Bioengineering and Bioscience, Georgia Institute of Technology,
Atlanta, GA, USA
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BMC Biotechnology 2015, 15:70 doi:10.1186/s12896-015-0190-4
The electronic version of this article is the complete one
and can be found online at:http://www.biomedcentral.com/1472-6750/15/70
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Received:
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17 March 2015
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Accepted:
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29 July 2015
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Published:
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7 August 2015
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© 2015 Dodson and Levine.
Open Access This article distributed under the terms of the
Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/),
which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/)
applies to the data made available in this article, unless otherwise stated.
Background
Cell therapies are an emerging form of healthcare that offer
significant potential to improve the practice of medicine and provide benefits
to patients who currently have limited or no treatment options. Ideally, these
innovative therapies can complement existing small molecule, biologic and
device approaches, forming a so-called fourth pillar of medicine and allowing
clinicians to identify the best treatment approach for each patient. Despite
this potential, cell therapies are substantially more complex than small
molecule or biologic interventions. This complexity poses challenges for
scientists and firms developing cell therapies and regulators seeking to
oversee this growing area of medicine.
Results
In this project, we retrospectively examined the development
of seven cell therapies – including three autologous interventions and four
allogeneic interventions – with the aim of identifying common challenges
hindering attempts to bring new cell therapies to market. We complemented this
analysis with a series of qualitative interviews with experts in various
aspects of cell therapy. Through our analysis, which included review of extant
literature collected from company documents, newspapers, journals, analyst
reports and similar sources, and analysis of the qualitative interviews, we
identified several common challenges that cell therapy firms must address in
both the pre- and post-market stages. Key pre-market challenges included
identifying and maintaining stable funding to see firms through lengthy
developmental timelines and uncertain regulatory processes. These challenges
are not unique to cell therapies, of course, but the novelty of cell-based
interventions complicates these efforts compared to small molecule or biologic
approaches. The atypical nature of cell therapies also led to post-market
difficulties, including challenges navigating the reimbursement process and
convincing providers to change their treatment approaches. In addition, scaling
up production, distributing cell therapies and managing the costs of production
were challenges that started pre-market and continued into the post-market
phase.
Conclusions
Our analysis highlights several interrelated challenges
hindering the development of cell therapies. Identifying strategies to address
these challenges may accelerate the development and increase the impact of
novel cell therapies. Tomado de envio de bcm
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