The Alliance for Regenerative Medicine Releases Report Analyzing Workforce Needed to Support Sustainable Biomanufacturing Of Cell And Gene Therapies In The United States

Washington, DC – March 16, 2023

The Alliance for Regenerative Medicine (ARM) today released its Workforce Report Gap Analysis for the Cell and Gene Therapy Sector. The report highlights the workforce needed for sustainable biomanufacturing of cell and gene therapies (CGTs) in the United States.

The report was developed in response to an executive order signed by President Joe Biden in September 2022 that launched the National Biotechnology and Biomanufacturing Initiative. This initiative aims to enable the United States to harness the full potential of biotechnology and biomanufacturing, and improve patient access to innovative medicines.

CGTs continue to transform medicine and human health as they offer durable, potentially curative treatments for rare and prevalent diseases – including those where traditional pharmaceutical drugs have failed. Investment into developing a skilled workforce for the sector is key in enabling patient access to these advanced therapeutics across the United States.

“The strength of the workforce within the cell and gene therapy sector is crucial for building a robust bioeconomy in the United States,” said Natalie Fekete, ARM’s Manager for Science and Industry Affairs and the lead author of the report. “Our report paints a picture of the current landscape, and maps out key strategies and practices to fill anticipated gaps in skills, education, and diversity.”

Key findings from the report include:

  • The United States is Leading the CGT Sector – Of the 2,000+ clinical trials that are active worldwide, 43% have sites in North America, and up to a dozen regulatory decision are expected in the U.S. during 2023.
  • Quantifying the Workforce Gap in the CGT Sector – 73% of subject matter experts surveyed in the report identified either quality control, analytical development, or manufacturing as the most challenging sector positions to fill. This shows a pressing need for talent in the commercialization process that is only expected to grow.
  • The Landscape of CGT Hubs Has Evolved Across the United States – While traditional biotech hotspots in California and Massachusetts remain attractive, smaller CGT pockets have emerged in areas such as Ohio and Texas.
  • Successful Models for Collaboration – Flexible training and credential-building can help upskill or re-skill the workforce as needed.
  • The Role of the U.S. Food and Drug Administration (FDA) in the Sector – With an influx of new approvals expected by the FDA there is an opportunity for the sharing of best practices to foster deeper understanding of advanced technologies emerging in CGT.
  • Key Strategies for CGT Workforce Development – Incentives and apprenticeships are essential for attracting a diverse demographic of talent, and to improve inclusion and opportunities for minorities.

ARM continues to support coordinated partnerships between government, industry, and scientific and educational institutions to ensure a sustainable workforce and maintain U.S. competitiveness in this rapidly evolving field.

About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and to modernize healthcare systems so that patients benefit from durable, potentially curative treatments. As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations.