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.

Based on experience and the existing limited research literature in biotechnology corporate governance, the authors propose potential attributes of minimum corporate governance standards for biotechnology companies, as a basis for further quantitative and qualitative research. The authors assert that the recent proliferation of biotechnology start-up organisations is substantively changing inter- and intra-organizational cultures throughout the healthcare sector via a 'cascade of governance'. Therefore, governance decisions and actions - both positive and negative - that are instituted in start-up biotech companies may set new norms for other start-up biotech companies, the larger (bio)pharmaceutical companies by which they are acquired and the range of healthcare sub-sector actors that interact with biotechnology companies. The authors stress the importance of appropriate, proportionate and consistent biotech corporate governance throughout company lifecycles, not simply to support value inflection or as a response to a crisis. Fail to govern, fail to succeed - for investors and, most importantly, for patients.

The contemporary pharmaceutical industry has its origins in the fine chemicals industry, including dyes and chemical refining. Biotechnology can trace its roots back to brewing, food processing and rudimentary medical practice. Medical devices-including diagnostics-is an evolution of metal working, consumer electronics and, in some cases, providers of primitive surgical tools for barbers. This unlikely constellation of trades, services and technologies is the foundation of the contemporary pharmaceutical industry. This healthcare tapestry is an act of a continuous and ongoing evolution, as are the regulations which govern it.