Decision support tools for regenerative medicine: systematic review
<strong>Background:</strong> 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. <strong>Object...
| Main Authors: | , , , , , , , |
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| Format: | Journal article |
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Journal of Medical Internet Research
2018
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| _version_ | 1826297185738686464 |
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| author | Lam, C Meinert, E Alturkistani, A Carter, A Karp, J Yang, A Brindley, D Cui, Z |
| author_facet | Lam, C Meinert, E Alturkistani, A Carter, A Karp, J Yang, A Brindley, D Cui, Z |
| author_sort | Lam, C |
| collection | OXFORD |
| description | <strong>Background:</strong> 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. <strong>Objective:</strong> 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. <strong>Methods:</strong> 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. <strong>Results:</strong> 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. <strong>Conclusions:</strong> 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. |
| first_indexed | 2024-03-07T04:27:43Z |
| format | Journal article |
| id | oxford-uuid:cd3d0a48-dc3b-47bc-a693-2f93f721f99b |
| institution | University of Oxford |
| last_indexed | 2024-03-07T04:27:43Z |
| publishDate | 2018 |
| publisher | Journal of Medical Internet Research |
| record_format | dspace |
| spelling | oxford-uuid:cd3d0a48-dc3b-47bc-a693-2f93f721f99b2022-03-27T07:27:20ZDecision support tools for regenerative medicine: systematic reviewJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:cd3d0a48-dc3b-47bc-a693-2f93f721f99bSymplectic Elements at OxfordJournal of Medical Internet Research2018Lam, CMeinert, EAlturkistani, ACarter, AKarp, JYang, ABrindley, DCui, Z<strong>Background:</strong> 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. <strong>Objective:</strong> 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. <strong>Methods:</strong> 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. <strong>Results:</strong> 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. <strong>Conclusions:</strong> 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. |
| spellingShingle | Lam, C Meinert, E Alturkistani, A Carter, A Karp, J Yang, A Brindley, D Cui, Z 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 |
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