The development and production of cell gene and tissue (CGT)-based therapies requires a specialized workforce. Entering the CGT arena is complex because it involves different scientific and biomedical aspects (e.g., immunology, stem cell biology and transplantation), as well as knowledge of regulatory affairs and compliance with pharmaceutical quality standards. Currently, both industry and academia are facing a worldwide workforce shortage, whereas only a handful of educational and training initiatives specifically address the peculiarities of CGT product development, the procurement of substances of human origin, the manufacturing process itself and clinical monitoring and biovigilance. The training offered by traditional Master's and PhD programs is not suited for training a skilled workforce ready to enter the increasingly fast-growing CGT field. Indeed, typically these programs are of long duration and only partially cover the required competencies, whereas the demand for a specialized workforce relentlessly increases. In this paper, we (i) present and discuss our understanding of the roots of current growth acceleration of the CGT field; (ii) anticipate future workforce needs due to the expected increase of marketed CGT-based therapies and (iii) evaluate potential solutions that seek to adapt, develop and implement current educational and training initiatives. Importantly for these solutions, we call for scientific societies, such as the International Society for Cell & Gene Therapy, to play a more active role and act as catalysers for new initiatives, building bridges between academia and Industry to establish effective educational and training programs that will engage and prepare a new generation of qualified professionals for entry into the CGT field.
Keywords: advanced therapy medicinal products; capacity-building; career development; competency skills; education; training; workforce shortage.
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