Filling the gap: the workforce of tomorrow for CGT manufacturing as the sector advances

Emily Hopewell; Nirupama Rupa Pike; Josephine Lembong; Matthew Hewitt; Natalie Fekete

doi:10.1016/j.jcyt.2024.03.007

Filling the gap: the workforce of tomorrow for CGT manufacturing as the sector advances

Cytotherapy. 2024 Mar 12:S1465-3249(24)00092-6. doi: 10.1016/j.jcyt.2024.03.007. Online ahead of print.

Authors

Emily Hopewell¹, Nirupama Rupa Pike², Josephine Lembong³, Matthew Hewitt⁴, Natalie Fekete⁵

Affiliations

¹ Assistant Professor of Clinical Medical and Molecular Genetics, Director, Cell and Gene Therapy Manufacturing, Chief Operations Officer, Brown Center for Immunotherapy Indiana University, Indianapolis, IN, USA.
² Senior Director and Global Head of Strategic Alliances, Cell Therapy, Catalent Pharma Solutions, Somerset NJ, USA.
³ Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine, Washington, DC, USA.
⁴ Vice President, Technical Officer CGT & Biologics, Charles River, Hanover, MD, USA.
⁵ Manager, Science and Industry Affairs, Alliance for Regenerative Medicine, Washington, DC, USA. Electronic address: nfekete@alliancerm.org.

PMID: 38573277
DOI: 10.1016/j.jcyt.2024.03.007

Abstract

Workforce education and development are key cornerstones in advancing and maturing the Cell & Gene Therapy sector. A skilled worker shortage can significantly impact and delay progress as well as the quality of output for any developer, thereby negatively impacting a patient's access to life-saving treatments. Several roundtable discussions were held at the International Society for Cell & Gene Therapy (ISCT) 2023 Annual Meeting to dive deeper into the current state of workforce development and solutions to address this bottleneck. One roundtable discussion was co-hosted by the Alliance for Regenerative Medicine (ARM) and ISCT, which focused on the gap analysis provided for the United States Cell & Gene Therapy (CGT) sector, highlighting the lack of skilled workers in manufacturing and quality control. In this manuscript, the roundtable participants continue this conversation, review the roles and staffing requirements in both academic and industry as well as small and large company settings. The adoption of increased manufacturing automation is one promising solution to propel the sector forward. However, automation alone won't replace on-site staff, but will lower the bar to entry for a larger pool of people and require different training. This paper also addresses the workforce development and training paradigm shift as advanced manufacturing techniques are implemented, which will differ considerably based on the type of manufacturing efforts, thus emphasizing the need for a well-thought-out strategy to up-skill and re-skill the technical workforce to adapt to these advancements. Organizations such as ISCT and ARM have a role to play in propelling the field forward, providing awareness and education to stakeholders at all levels, as well as acting as a convener and participating as a key stakeholder in discussions and partnerships between academia and industry towards solutions for training the best personnel for CGT manufacturing. This scope includes novel digital tools and technologies to simplify training to increase access to new talent pools interested in careers in a rapidly advancing sector.

Keywords: automation; education; manufacturing; training; workforce development.