An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol
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13643_2017_Article_517.pdf
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Author(s)
Pettitt, David
Arshad, Zeeshaan
Davies, Benjamin
Smith, James
French, Anna
Cole, Doug
Bure, Kim
Dopson, Sue
DiGiusto, David
Reeve, Brock
Date Issued
June 2017
Journal
Systematic Reviews
Publisher
BioMed Central
Citation
Pettitt, David, Zeeshaan Arshad, Benjamin Davies, James Smith, Anna French, Doug Cole, KIm Bure, Sue Dopson, David DiGiusto, Jeff Karp, Brock Reeve, Richard Barker, Georg Hollander and David Brindley. "An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol." Systematic Reviews 20176:120.
Version
Final published version
Abstract
Abstract - Background - Cellular-based therapies represent a platform technology within the rapidly expanding field of regenerative medicine and are distinct from conventional therapeutics—offering a unique approach to managing what were once considered untreatable diseases. Despite a significant increase in basic science activity within the cell therapy arena, alongside a growing portfolio of cell therapy trials and promising investment, the translation of cellular-based therapeutics from “bench to bedside” remains challenging, and the number of industry products available for widespread clinical use remains comparatively low. This systematic review identifies unique intrinsic and extrinsic barriers in the cell-based therapy domain. Methods/design - Eight electronic databases will be searched, specifically Medline, EMBASE (OvidSP), BIOSIS & Web of Science, Cochrane Library & HEED, EconLit (ProQuest), WHOLIS WHO Library Database, PAIS International (ProQuest), and Scopus. Addition to this gray literature was searched by manually reviewing relevant work. All identified articles will be subjected for review by two authors who will decide whether or not each article passes our inclusion/exclusion criteria. Eligible papers will subsequently be reviewed, and key data extracted into a pre-designed data extraction scorecard. An assessment of the perceived impact of broad commercial barriers to the adoption of cell-based therapies will be conducted. These broad categories will include manufacturing, regulation and intellectual property, reimbursement, clinical trials, clinical adoption, ethics, and business models. This will inform further discussion in the review. There is no PROSPERO registration number. Discussion - Through a systematic search and appraisal of available literature, this review will identify key challenges in the commercialization pathway of cellular-based therapeutics and highlights significant barriers impeding successful clinical adoption. This will aid in creating an adaptable, acceptable, and harmonized approach supported by apposite regulatory frameworks and pertinent expertise throughout the respective stages of the adoption cycle to facilitate the adoption of new products and technologies in the industry.
MIT Department
Harvard University--MIT Division of Health Sciences and Technology
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DOI of Published Version
https://doi.org/10.1186/s13643-017-0517-4
