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Joaquim Vives, PhD

October already. The beginning of the new academic year. There is a whole universe of educational and training opportunities available to shape new careers or advance in specialization. But is this also true in the Cell and Gene Therapy arena?

The acceleration of marketing authorizations in North America, Europe and Asia contrasts with apparently little progress in actual implementation of automation and intensification of bioprocesses to produce clinical grade cell-, gene-, and tissue (CGT)-based therapies. Indeed, the manufacture of these therapeutics is complex and still highly dependent on manual production. Given the specific skills and expertise needed to have sound training in the CGT technologies and thorough grounding in the regulatory and quality aspects concerning the development of CGT products, some manufacturers struggle to find professionals to keep up with production demand amid workforce shortages worldwide. This situation is not restricted to Industry but also happens in Academia, where a lack of scientists interested in becoming postdoctoral fellows has been reported (1, 2). From all the many different factors contributing to the current situation (e.g., competitive wages, willing to relocate, migration policies, values of the millennial generation), education and training are of key importance. However, the rapid growth of the CGT field contrasts with the long timescales needed to address talent shortage. Hence, this disparity creates the need for new efforts and creativity to improve workforce development programs – not only focusing on manufacturing but in all steps of product development, manufacture, and clinical use, as well as continuous training to keep abreast of scientific and technical progress.

At the past ISCT 2022 Annual Meeting in San Francisco, we had the opportunity to discuss CGT Workforce Development and how to address challenges in maintaining competent, skilled personnel. The group also explored the problems and cross-sector impact caused by a shortage of a trained workforce as the CGT field tries to keep up with its exponential growth. Neither current academic tracks nor the industry seem to be prepared to coach the new generation of professionals on the skills and competences needed for the design, development, production and characterization of CGT-based therapies in a tightly regulated environment (2, 3). In this sense, ISCT showed its commitment to offer specialized training and workforce development programs, including:

• The Workforce Development in Biomanufacturing Program, which is a global initiative in partnership with Cell Manufacturing Technologies (CMaT) addressing key topics in CGT manufacturing and development, such as: Stem Cell and Immune Cell Engineering and Therapies; Quality Assurance and Regulatory Framework; Cell Bioprocessing and Manufacturing; Cell Product Characterization and Importance of Standards.
• EU Master in Manufacturing of Advanced Therapy Medicine Products (ATMPs) Scholarship Program, for which the ISCT offers full tuition scholarships for 3 ISCT EU Members to enroll in the 2023/2024 Master or Specialization Degree in Manufacturing of Advanced Therapy Medicinal Products at the University of Granada/Andalusian Network for the design and translation of Advanced Therapies (ANd&tAT), which has been designed for professionals currently working (or intending to work) in Good Manufacturing Practice (GMP)-compliant CGT manufacturing, as well as for professionals with diverse backgrounds seeking to update their knowledge.
• Educational Program on Advanced Therapy Manufacturing, in partnership with the ANd&tAT, is an online educational program on Advanced Therapy Manufacturing that is free-of-charge for ISCT members and covers the fundamentals of ATMP regulation and the specific knowledge necessary for the development of CGT-based medicinal products, including: Cell and Gene Therapy Manufacturing Methods; Quality Assurance; Product Development Pathways; GMP Compliance; Investigational Medicinal Product Dossier (IMPD) Writing; Biosafety

These initiatives are in line and complement those offered by other scientific and professional societies, which are also aware of the situation and have explored different ways to engage scientists and technologists in CGT career paths (e.g., the Spring school by the ESGCT, Summer/Winter school by TERMIS, short courses by ESACT or the range of courses offered by EBMT).

Moreover, the ISCT EU executive committee is currently identifying educational and training initiatives that will contribute to specialization of existing professionals while developing new careers in the CGT field. This has been identified as strategic issue under Prof. Massimiliano Gnecchi’s presidency, and its ultimate goal is to provide ISCT members with educational and training programs and projects, adequate to their needs, in order to improve their competences, scientific capabilities and labor perspectives. Focusing on the CGT-related education and training landscape specifically in Europe, the initial analysis identified key areas of study (namely, basic research, early discovery, non-clinical development, clinical development, FDA/EMA review, and post-market monitoring). Remarkably, the value chain from idea conception to post-market monitoring is covered either by short courses providing broad updates on specific key areas, with rapid response to accommodate the contest to the needs of the students, or formal educational programs (e.g., BSci, MSc, PhD) offered by universities issuing official diplomas, but needing to invest longer times and money.

Finally, although it is urgent to offer educational and training activities to meet current CGT manufacturing requirements, this may change in the near future with a broad implementation of the use of bioreactors and automation. Therefore, it is key to anticipate the growing lack of professionals in other steps of manufacturing, such as cell procurement, or real-world data management, along with the changing needs and values of an evolving society.

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