Cargando…

Decision Support Tools for Regenerative Medicine: Systematic Review

BACKGROUND: Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE: The objective of this review was to inv...

Descripción completa

Detalles Bibliográficos
Autores principales: Lam, Ching, Meinert, Edward, Alturkistani, Abrar, Carter, Alison R, Karp, Jeffrey, Yang, Aidong, Brindley, David, Cui, Zhanfeng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6315273/
https://www.ncbi.nlm.nih.gov/pubmed/30567696
http://dx.doi.org/10.2196/12448
_version_ 1783384255566446592
author Lam, Ching
Meinert, Edward
Alturkistani, Abrar
Carter, Alison R
Karp, Jeffrey
Yang, Aidong
Brindley, David
Cui, Zhanfeng
author_facet Lam, Ching
Meinert, Edward
Alturkistani, Abrar
Carter, Alison R
Karp, Jeffrey
Yang, Aidong
Brindley, David
Cui, Zhanfeng
author_sort Lam, Ching
collection PubMed
description BACKGROUND: Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE: The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS: We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS: We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS: Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.
format Online
Article
Text
id pubmed-6315273
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher JMIR Publications
record_format MEDLINE/PubMed
spelling pubmed-63152732019-01-28 Decision Support Tools for Regenerative Medicine: Systematic Review Lam, Ching Meinert, Edward Alturkistani, Abrar Carter, Alison R Karp, Jeffrey Yang, Aidong Brindley, David Cui, Zhanfeng J Med Internet Res Review BACKGROUND: Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE: The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS: We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS: We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS: Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated. JMIR Publications 2018-12-19 /pmc/articles/PMC6315273/ /pubmed/30567696 http://dx.doi.org/10.2196/12448 Text en ©Ching Lam, Edward Meinert, Abrar Alturkistani, Alison R Carter, Jeffrey Karp, Aidong Yang, David Brindley, Zhanfeng Cui. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.12.2018. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Review
Lam, Ching
Meinert, Edward
Alturkistani, Abrar
Carter, Alison R
Karp, Jeffrey
Yang, Aidong
Brindley, David
Cui, Zhanfeng
Decision Support Tools for Regenerative Medicine: Systematic Review
title Decision Support Tools for Regenerative Medicine: Systematic Review
title_full Decision Support Tools for Regenerative Medicine: Systematic Review
title_fullStr Decision Support Tools for Regenerative Medicine: Systematic Review
title_full_unstemmed Decision Support Tools for Regenerative Medicine: Systematic Review
title_short Decision Support Tools for Regenerative Medicine: Systematic Review
title_sort decision support tools for regenerative medicine: systematic review
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6315273/
https://www.ncbi.nlm.nih.gov/pubmed/30567696
http://dx.doi.org/10.2196/12448
work_keys_str_mv AT lamching decisionsupporttoolsforregenerativemedicinesystematicreview
AT meinertedward decisionsupporttoolsforregenerativemedicinesystematicreview
AT alturkistaniabrar decisionsupporttoolsforregenerativemedicinesystematicreview
AT carteralisonr decisionsupporttoolsforregenerativemedicinesystematicreview
AT karpjeffrey decisionsupporttoolsforregenerativemedicinesystematicreview
AT yangaidong decisionsupporttoolsforregenerativemedicinesystematicreview
AT brindleydavid decisionsupporttoolsforregenerativemedicinesystematicreview
AT cuizhanfeng decisionsupporttoolsforregenerativemedicinesystematicreview