The recent rapid growth of cell and gene therapies (CGTs) has led to a gap in the talent market that represents both a challenge and opportunity for the sector.
Whilst the research base for CGTs is well-established, the last five years have seen a ramping up of therapies being brought to market and treating patients. In the US over half of FDA approved CGTs gained authorization since 2014, bringing the current total up to 17. With almost 300 CGTs currently in development, the UK Cell and Gene Therapy Catapult predicts tens of thousands of patients to be benefiting from CGTs in the coming decade.
Figure 1. Number of CGTs with market authorization (MA) from 2001-2018. Taken from Cuende et al. 2018
The increasing demand for current and upcoming therapies is placing significant strain on parts of the CGT pipeline. As the industry is young and highly specialized, this growth has exposed gaps in the talent pool. Several key areas include:
- Manufacturing… Mass production of critical components of cell and gene therapies, such as viral vectors, is a critical bottleneck for CGT companies. Production of CGTs is complex and highly regulated, with sites having to comply with strict “current Good Manufacturing Practice” (cGMP) standards set by national regulators. Scientists with experience working in these environments are highly sought after, and decisions about production facility locations often hinge on the availability of manufacturing expertise. Allogene Therapeutics’ recent plans to build a new manufacturing site in the biotech hub in San Francisco’s Bay area highlight this. The UK (a world-leader in CGT manufacturing), has announced apprenticeship schemes to help meet the need for these skills.
- Senior management… The correct senior management is critical to the success of CGT companies. A recent report by the RSA concluded that fast delivery times and technical challenge of CGTs required management teams with a broader skills-base than in other drug discovery companies. Analyzing 182 CGT companies, the report finds that the majority (72%) of founders have scientific/medical expertise with a significant minority (24%) having managerial experience. Ensuring that operational and commercial management are on-board early in development was highlighted as critical to company success.
- Regulatory expertise… The regulatory environment for CGTs is constantly developing. In 2018, the FDA and EMA released new regulatory guidelines for design, manufacture and testing of gene therapies. Whilst only 4% of CGT company founders have regulatory experience, this skill set becomes critical in commercialization and/or exit phases of growth.
As the CGT market continues to expand, there will only be an increasing demand for those with the scientific, manufacturing and commercial experience to tackle the unique challenges facing the CGT sector. In the interim, many CGT companies are using CROs like Absorption Systems to outsource expertise in specialist areas such as analytical testing. These services are crucial to bridge the talent gap whilst training schemes, attractive career paths and continued investment help the market reach its full potential in the coming decade and beyond.