Staffing shortages have long hampered the FDA’s efforts to oversee and advance development of cell and gene therapies, but new research finds that the problem is likely far more widespread across the industry than previously acknowledged.
The reports, published by the U.S. Government Accountability Office (GAO) and the Alliance for Regenerative Medicine, found that a lack of trained workers, particularly in entry-level, vocational positions, throughout the R&D life cycle are threatening the development of these potentially curative treatments.
Leslie Gordon, director of GAO's healthcare team and a co-author of the agency’s study, which was mandated by Congress, noted that industry leaders interviewed for the report stressed the need for more “technical laboratory staff,” rather than higher-level researchers.
Similarly, the Alliance for Regenerative Medicine’s study found that the positions with the most egregious shortages include manufacturing, analytical development and testing, as well as quality control, with the gap in manufacturing “expected to widen the most” in the coming years.
The driving force of these shortages is a lack of education, Gordon said. As cell and gene therapies have rapidly proliferated — with more than 2,000 in clinical trials currently, up from just under 300 in 2018 — the infrastructure needed to train lower-level laboratory technicians, biomanufacturers, data scientists and regulatory experts who work on them hasn’t proven to be sustainable.
For instance, the GAO report highlighted that laboratory technician roles, which in other medication areas may be filled by workers with two-year degrees or certificates, require specialized skills for regenerative medicines that are not widely taught in associates programs. That includes "developing assays and conducting flow cytometry and mass spectrometry,” the report said.
With fewer qualified candidates to fill these positions, companies have turned to “individuals with higher levels of education than may be necessary — such as bachelor’s or master’s degrees,” the report said. But that’s led to higher turnover rates, as these staff members leave to pursue the advanced research careers they were trained for.
The problem is further compounded at academic and government research institutions where the pay rates are likely not as enticing to candidates with the appropriate skill set, Gordon said, noting that “the federal government pays according to skill level,” whereas private industry tends to have a more flexible pay scale. And there isn’t any federal or national data available specifically on the regenerative medicine workforce to show the full extent of the issue.
A growing problem
The problem is only bound to grow worse as cell and gene therapy manufacturing techniques become more scalable, the reports also suggested.
“They're saying there's a shortage now across the dimensions of research and development … but they said particularly if you start thinking about wanting to scale this and do biomanufacturing, there's not a pipeline (of workers) and there aren't many solutions readily available,” Gordon said.
One of those solutions is to add to the number of educational institutions that offer associates and certificate programs training students in biologics development, including R&D in biomanufacturing, practices with laboratory and manufacturing equipment, good manufacturing, quality assurance and regulatory requirements.
Currently, only about 7% of the 1,043 community colleges across the U.S. offer biotech-related degrees, though some are beginning to develop curricula to meet the demand, the Alliance’s report said. It recommended that academic institutions and drug developers consider implementing virtual and augmented reality to help future workers “visualize their workplace,” but also acknowledged that these programs should not “fully replace” hands-on learning.
"Particularly if you start thinking about wanting to scale this and do biomanufacturing, there’s not a pipeline (of workers) and there aren’t many solutions readily available."
Director, healthcare, GAO
Another step stakeholders in both reports suggested to alleviate these shortages was developing a common curriculum franchised “across colleges as well as industry” that would receive a stamp of approval from a national organization and would eliminate the need for any additional on-the-job training.
“Such a curriculum would also make such programs available to more diverse communities, thereby increasing workforce diversity,” the GAO report said.
These trainings could include “modular certificates” that workers would need to achieve to provide a steadier career path and continuing education, the Alliance argued.
However, Gordon said that a standardized curriculum might not be necessary and “merits further consideration” from policymakers.
Still, as government and industry groups look to solve these educational gaps over the long term, both reports suggested that some form of action will be needed to maintain the cell and gene workforce and ensure the continuing development of important medications.