Tony Khoury, Executive Vice President of Project Farma and Anshul Mangal, President & General Counsel of Project Farma, share how the industry is leveraging stronger education programmes to close the advanced therapy talent gap.
The cell and gene therapy industry has experienced exponential growth in the last three years and as funding for the field continues to break records there are no signs of a slowdown. With 2,261 ongoing clinical trials in regenerative medicine, the FDA expects to approve1 between 10 and 20 new cell and gene therapies a year by 2025. Gene editing and CRISPR technologies are also quickly advancing with many companies heading to the clinic in the next few years. The need for solutions to the industry’s biggest bottlenecks are growing daily.
The complexities of manufacturing advanced therapies have resulted in a significant talent shortage across the industry. In order to keep up with ever growing demand and deliver these therapies to the patients who need them, the industry must work together to solve the talent shortage.
Where are the biggest gaps?
Issues with talent acquisition and retention are felt across the life science and pharma industries, there simply are not enough skilled workers to meet market demand. Expertise at the R&D level has led to significant breakthroughs for cell and gene therapies, but few products have reached the commercial level. The skills required for these technical and manual processes are highly specialised, leaving insufficient personnel for scale up from the bench. Over the past five years, job change percentages amongst R&D jobs have also been on the rise in key biotech hubs across the country. Areas in California have seen as much as a 222% increase since 2017 while North Carolina is facing between 80-109% in job changes in the sector.
There are shortages across the entire industry, but most critically in manufacturing. Even with recent advances in automation, AI and machine learning, the advanced therapy sector is still heavily reliant on manual processes, so these technological leaps cannot yet backfill the workforce gap.
Executive level positions are also in high demand. Experienced but flexible leaders are needed to successfully launch and sustain new and existing advanced therapy companies. Industry know how is important, but as the industry grows and best practices are established, being an adaptable leader is critical.
In order to safely deliver these therapies to the patients who need them, they must undergo a rigorous regulatory review process. However, even the FDA is experiencing lack of bandwidth within the governing bodies that participate in regulatory processes and reviews. They are further troubled by the number of regulatory affair professionals graduating2 compared with the projected needs of the biotech industries.
Supporting the next generation of talent
While the talent shortage is a complex problem, the industry is making great strides to come together to find solutions. Leveraging private-public partnerships and continuing to disseminate experiences and information across the industry will help elevate the current generation of skilled workers. In an effort to focus on the next generation of talent, funding is being poured into the university level to support advanced degrees and the technical workforce for the cell and gene therapy industry. Last April the NSF awarded a $573,347 grant3 to a Pennsylvania community college to support efforts in elevating the advanced technical workforce for the cell and gene therapy industry. In the summer of 2021, the governing board of the California Institute for Regenerative Medicine (CIRM) awarded $51.08 million to 15 community colleges and universities across California to fund undergraduate and master’s level programmes that will provide the required skills to join the advanced therapy industry.
Universities are also now offering multi-day intensive, hands-on training to teach the critical skills the industry depends on like vector production and manufacturing scale up operations. These courses are open to anyone, from biomanufacturing employees and support personnel looking to transition to advanced therapies, research scientists from academia, and vendors who support the advanced therapy manufacturing industry. North Carolina State University’s Biomanufacturing training and education centre (BTEC) is offering several trainings4 this year that covers critical skills like calculating step yields for downstream operations, and basic scale up calculations.
The programme curricula are designed to address some of the industry’s biggest bottlenecks like vector production5. Another university programme6 offers intensive courses on understanding the complex regulatory landscape of advanced therapies, clinical trial design, and how to produce credible business plans for the application of advanced therapies.
The advanced therapy industry and its supporting investors are making strides to increase academic engagement and knowledge sharing in the ecosystem. With many products in early phase development, cell and gene therapy commercialisation is set to experience exponential growth in the coming years. With talent in the technical operations space being in high demand, organisations must continue to work together to close this gap. There isn’t enough skilled talent to meet industry needs, so leaders must put an emphasis on training through partnerships and educational programmes. As the 2200+ ongoing clinical trials move to commercialisation, the talent gap is going to continue to grow unless we ramp up training and education efforts across the industry.
Included in the DDW Cell and Gene Therapy ebook.
Job Change Percentage comparison in specific markets in the US, 2017-2020. Graph from EMSI, Regional Comparison Report. February 2022.References
- https://www.biopharmadive.com/news/fda-marks-gene-therapy-consistency/600445/#:~:text=Previously%2C%20Marks%20and%20then%2DFDA,T%20cell%20therapies%20for%20cancer
- https://researchfeatures.com/talent-shortage-regulatory-affairs-cause-for-concern/
- https://www.mc3.edu/news/2021/04/national-science-foundation-grant
- https://www.btec.ncsu.edu/industry/short_courses/gene_therapy.php
- https://www.nature.com/articles/d42473-021-00020-x
- https://www.kingshealthpartners.org/latest/3438-students-praise-advanced-therapies-intensive-course-as-a-rare-opportunity
About the authors
Tony Khoury is an experienced industry leader in life sciences, specifically, biologics and advanced therapies. As a member of the Project Farma leadership team, Khoury has spearheaded the firm’s growth in the biologics and most recently next generation medicines. Khoury has led the creation of Project Farma’s Advanced Therapy Manufacturing Playbook which has helped develop the largest cell and gene therapy manufacturing footprint in the world.
Anshul Mangal is the President & General Counsel of Project Farma (PF) and Precision ADVANCE. Mangal founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Mangal’s leadership, PF pioneered the industrialisation of advanced therapies including two notable, commercially approved cell and gene therapies and created PF’s Advanced Therapy Manufacturing Playbook.
