|4th July 2018
Cell and gene therapy is no longer science fiction. Within the last two decades, we have seen this area of medicine move from an idea to a reality. Novel technologies, coupled with programmes designed to drive cell and gene research and development, are ushering in a new era of therapies. These initiatives are helping healthcare systems to move towards a model of prevention and precision while meeting patients’ unmet needs.
In this year alone, the FDA has taken the groundbreaking step of approving two CAR-T therapies. In August, Novartis’ revolutionary CAR-T therapy, Kymriah, was approved. This was quickly followed by the approval of Kite’s Yescarta in October.
These developments mean biotech professionals will need to develop a new set of skills. Each breakthrough is reliant on complex and highly specific technology, making the manufacturing and reproduction of these therapies challenging.
As a result, biotech organisations are facing a skills crisis. Today’s biochemical engineers are developing highly specialised technical knowledge, which is sometimes difficult to transfer to other biotech organisations.
Blue Latitude Health spoke to Dr Ivan Wall, Reader in Cell & Gene Therapy Bioprocessing at University College London (UCL), to find out how he is arming the next generation of biotech professionals with the sophisticated blend of skills the industry requires.
Dr Ivan Wall is an expert in all things stem cell. He has spent the last eight years in the Department of Biochemical Engineering at UCL, one of the UK’s top universities.
He is working hard to combat the skills shortage facing the sector by training students across an education continuum, from undergraduate to doctoral level, on how to re-purpose skills from biopharma.
He is also coordinating outreach activities with school children to inspire future generations of biochemical engineers. As a result, he is at the forefront of inspiring the next generation of scientists to make breakthroughs in cell and gene therapy.
In June 2016 the UK voted to leave the EU, prompting a new direction for Britain’s industrial strategy and a sharp focus on biotech and life sciences – fuelled by leading universities. With Brexit on the horizon, there is a worry that the already low number of UK scientists with expertise in cell and gene therapy will dwindle further.
"The life sciences sector is a very diverse ecosystem. You need different flavours of graduates and skillsets, according to the different areas people are working in. It’s a very broad area – much broader than people would initially think."
“We cannot train skilled people quickly enough,” Ivan reveals. “We work with a range of industry partners and we’re frequently asked to identify good students who are coming up to graduation. The life sciences sector is a very diverse ecosystem. You need different flavours of graduates and skillsets, according to the different areas people are working in. It’s a very broad area – much broader than people would initially think.”
This skills shortage is a major challenge for the sector. Currently, the number of biotech companies emerging is growing much faster than the talent pool. As a result industry and academia have united, making recommendations to the UK government on how to attract top talent.
The proposals include reducing recruitment barriers for non-UK nationals by simplifying the Tier-2 visa process, speeding up visa approvals, reducing salary restrictions, and the creation of a “high-level recruitment fund”, which echoes the Canadian model.
"We’re bringing online new degree programmes that are half engineering and half medical science to create a new flavour of multidisciplinary graduate"
The complex nature of research and development in these therapy areas means the next generation of scientists will need multifaceted skills to make breakthroughs in both the science and the innovative technology driving the industry forwards. Now a new holistic model for training is emerging. UCL is rising to the challenge by developing new tactics, such as combining medical science and engineering courses to ensure graduates are equipped with a convergence of skills.
“We’re bringing online new degree programmes that are half engineering and half medical science to create a new flavour of multidisciplinary graduate. Our MSc course in Biochemical Engineering is a one-year conversion course. It brings engineers and people from the life sciences sector into the department to learn about biochemical engineering and the specifics of cell and gene therapy manufacturing. It’s going from strength to strength,” he reveals.
While the skills shortage is a top concern for the biotech industry, there is another hurdle stagnating innovation in cell and gene therapy.
As the focus shifts to the development of personalised medicine, further innovation in the manufacturing process and equipment is needed. Giving the next generation of scientists ample opportunity to solve this challenge is crucial for ensuring cutting-edge therapies can be produced at a commercial scale and benefit all patients.
The UK’s key competitors in Europe and the US are storming ahead in this field, funnelling investment into manufacturing innovations. However, during the last decade, the UK has lagged behind.
Now things are changing. With the advent of personalised medicine, biotechs and academia are focusing their efforts on ensuring the manufacturing process can be both scaled up and reproduced.
"The goal is to try and accelerate access to these medicines by reducing the time taken to learn how to manufacture them. This is achieved by sharing data and by sharing experiences. It’s becoming a model around the world."
UCL is working with students and an industry consortium to transform the manufacturing process for precision medicine. The £12m Future Targeted Manufacturing Healthcare Hub is addressing manufacturing, business and regulatory hurdles in order to ensure new targeted innovations can be manufactured at a cost that is affordable to society.
“We look at the manufacturing challenges we are facing for emerging healthcare products, such as stratified protein therapeutics and personalised cell therapies. Manufacturing for these products is going to look very different to the process used for large-scale production of biotech products, like recombinant insulin.” Ivan explains.
“We share information with the users and they share with us. The goal is to try and accelerate access to these medicines by reducing the time taken to learn how to manufacture them. This is achieved by sharing data and by sharing experiences. It’s becoming a model around the world.”
Members of the Hub are rising to the challenge, looking for innovative ways to transform supply chain management with novel technology, analytics and control algorithms. This will mean investment in process analytic technologies and methods for monitoring and controlling the cell products, as they are created, to detect failures.
"Technology born out of barcodes, tracking and scanning will become critical as we embrace things like cellular immunotherapies."
“Tracking the chain of custody and making sure the right cells go to the right patient is vital, particularly if we move to a system where we’re processing 100 or 1000 patient samples at any one time,” says Ivan.
“Technology born out of barcodes, tracking and scanning will become critical as we embrace things like cellular immunotherapies. We have to be able to track and understand exactly what the cell product is, at every stage of the process, so you don’t get any mix-ups.
“There are exciting opportunities now for people working upstream in viral vector production. At the moment virus production, storage and stability are challenging. We need to work out how to make large quantities reproducibly.”
The approval of two CAR-T therapies this year illustrates how cell and gene therapies are turning from scientific dream to reality, with companies in the immunotherapy field ramping up research and development activity.
“It would be nice to think that in the next ten to fifteen years, we’ll see a pipeline of new medicines emerging off the back of these early successes, like Kymriah, which make it into routine practice as a first-line treatment. When you look over the last decade a hell of a lot has changed,” Ivan explains.
“Ten years ago, we would not have dreamed we would be genetically modifying a patient’s own cells, putting them back in their bodies, and then eradicating tumours or blood cancers that otherwise would have killed the patient very quickly. It’s such a disruptive advancement – it’s just incredible to think it has all been made feasible through advancements in gene editing.”
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|27th August 2020
Precision and personalised medicines are more than products, they are services in their own right. So, how should pharma approach this uncharted territory to ensure targeted therapies work for patients?