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Syst Rev. 2017 Jun 26;6(1):120. doi: 10.1186/s13643-017-0517-4.

An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol.

Author information

1
The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford, UK.
2
Department of Paediatrics, University of Oxford, Oxford, UK.
3
University of St. Andrews School of Medicine, University of St. Andrews, St. Andrews, UK. za23@st-andrews.ac.uk.
4
, Docherty Gardens, Glenrothes, KY7 5GA, UK. za23@st-andrews.ac.uk.
5
Orthopedic Surgery Departement, University of Cambridge, Cambridge, UK.
6
Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
7
Flagship Ventures, Cambridge, USA.
8
Sartorius Stedim, Göttingen, Germany.
9
Said Business School, University of Oxford, Oxford, UK.
10
Division of Cell Transplantation and Regenerative Medicine, University of Stanford, Stanford, USA.
11
Harvard Medical School, Harvard University, Boston, USA.
12
Brigham and Women's Hospital, Boston, USA.
13
Harvard-MIT Division of Health Sciences and Technology, Cambridge, USA.
14
Harvard Stem Cell Institute, Cambridge, USA.
15
Department of Biomedicine, University of Basel and Basel University Children's Hospital, Basel, Switzerland.
16
Centre for Behavioral Medicine, UCL School of Pharmacy, University College London, London, UK.
17
USCF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), Stanford, USA.

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.

KEYWORDS:

Cell-based therapies; Clinical adoption; Commercialization; Translational medicine

PMID:
28651620
PMCID:
PMC5485574
DOI:
10.1186/s13643-017-0517-4
[Indexed for MEDLINE]
Free PMC Article

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