Driving novel therapies forward

Mark Johnson, Client Services Director, Executive Search at PiR, talks about the fast-moving field of gene and cell therapies, the emerging manufacturing pipeline and the importance of transferrable skills in recruiting knowledgeable and experienced talent for key roles in this sector.

With the first gene therapy gaining EU license approval in 2012, the appetite of both large pharmaceuticals and biotechs to develop advanced therapies has never been stronger. If we look at the current development landscape, the large pharmaceutical organisations, such as GSK, have shown significant commitment to developing advanced biologics. This is coupled with substantial biotech activity and a number of accelerated programmes moving into clinical trials in the last year – Cell Medica, Reneuron, NighstaRx, Autolus and Oxford BioMedica to name just a few. This UK drive in advanced biologics is supported by the Gene and Cell Therapy Catapult, the government driven initiative to support UK companies in whatever capacity is required to move advanced biologics into a commercially viable and successful product.

In the last few years it has also become clear that gene therapies have been receiving more focus due to greater similarities with current vaccine manufacture. As recently as five years ago, companies were only just beginning to understand how manipulation of genes and cell lines could be developed into novel therapeutics. Now the focus is shifting to how this cutting-edge technology can be translated from research into viable treatment, and eventually turned into commercial ventures. This new pipeline will require not only GMP manufacturing capabilities, but also knowledgeable leaders and experts with the experience to steer potential therapies through clinical trials and into production.

Towards commercial success

Although the production of advanced biologics is relatively new and complex, companies recognise the potential for revenue generation – for example, from cancer therapies – and are now discovering how to navigate the regulatory pathways leading to commercially viable manufacturing; from a manufacturing viewpoint, these are exciting times. For most, maintaining the supply chain is a significant hurdle; how can products be moved around cost effectively, and how do you scale up processes?

Historically, biotech laboratories have outsourced manufacturing to a third-party contract organisation. However, as more shared core facilities open, companies have the opportunity to establish their own production capabilities. These can be university-based units – ideal for small-scale production for pre-clinical or early clinical research – or large-scale regulated amenities designed to mimic manufacturing suites, allowing companies to optimise their processes and improve commercial viability. These processes can then be further scaled up for late stage clinical studies and commercial production. This approach gives companies complete control; as they fully understand the process, the risk profile is likely to be lower than if production is contracted out, improving the chances of success. But what about the leaders and experts who will drive forward this success?

Taking advantage of transferable skills

In the early days, as with every novel field of science, the pool of talent with an understanding of gene and cell therapies was very limited. Finding people with relevant experience in Phase 1 and 2 clinical trials, and an understanding of how to take products forward for commercial development, presented a significant challenge. The majority of candidates came from academic groups working on advanced biologics, and their experience was limited to pre-clinical or early clinical drug development. Without the help of commercially-focused developers, the likelihood of turning successful research into a new therapy that might someday be profitable was slim.

Given this shortage, the search was on for talent working in similar or related fields, particularly vaccines. The key was to recruit people with an understanding of the drug development process and the technical knowhow to transfer this experience to another field. Companies actively sought out individuals with previous involvement of developing an advanced biologic.

Of course, the market has moved on, and there is now a small and growing talent pool with relevant experience. However, growth of the industry continues to outstrip the availability of potential candidates. Having a clear understanding of what is required of a role enables the identification of candidates with transferrable skill sets to the gene and cell therapy pipeline . Also having a network with this highly sought after talent pool is key and this is where PiR’s network and expertise can, and has helped. Since the early days of advanced biologics, we have engaged with specialists in this novel field, developing an extensive knowledge of the marketplace and building strong relationships with both clients and the talent pool. By taking the time to fully understand each client – the company, its science, goals and the leadership team – we have frequently been able to deliver highly skilled candidates to new and challenging roles in the gene and cell therapy field, and look forward to continuing to play our part in driving these exciting new therapies forward.

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