Abstract
BackgroundDecisional 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.ObjectiveThe 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.MethodsWe 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.ResultsWe 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.ConclusionsOur 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.
Highlights
RationaleDecisional tools or decision support tools are tools that can be used to support complex decision making and problem solving
We aimed to provide a systematic update of the regenerative medicine decision support tool landscape, with a focus on tissue engineering, and cell and gene therapies, to identify the gaps in the literature and inform future development of decisional tools in the area
All the articles we identified focused on cell and ex vivo gene therapy; we found no decisional tools in tissue engineering or in vivo gene therapy
Summary
RationaleDecisional tools or decision support tools are tools that can be used to support complex decision making and problem solving. Decisional tools have been applied to monoclonal antibody and vaccine manufacturing decisions for over 20 years These tools have proved to be useful for understanding cost structures and risks in order to inform decisions in various areas, including technology evaluation, facility fit, and capacity planning [5,6,7,8,9,10]. 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. 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. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated
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