The Cell & Gene Collective publicly launched in May 2021. Lu Rahman caught up with Julian Cole, Country Medical Director of Gilead Sciences for the UK and Ireland to find out more about this cross-industry alliance between Astellas, bluebird bio, Bristol Myers Squibb, Kite (a Gilead company) and Novartis.
LR: What was the thinking behind the Collective? How will it help improve the uptake of these therapies in the UK?
JC: The Cell & Gene Collective was born out of the shared desire to transform the greatest number of patients’ lives through fast and wide appropriate access to cell and gene therapies on the NHS. We recognise that the UK has done a great job in bringing the first wave of cell and gene therapies to patients mainly with rare and orphan diseases, but we have a wave of them coming and a step change is needed. There is little scope to make this step up today – but we don’t think hope should wait.
We hope to build awareness and understanding of cell and gene therapies within the policy-making eco-system (including parliamentarians). This includes increasing the prominence of cell and gene therapy in access policy discussions, such as the National Institute for Health and Care Excellence (NICE) Methods review and the recently announced Innovative Medicines Fund (IMF) consultation.
We do this by encouraging policy makers to act with urgency to ensure system readiness in the NHS and an innovative and flexible environment for the evaluation of new cell and gene therapies as they move through the HTA process. This will be critical in the coming years.
LR: What are the benefits of collaborative work in drug discovery?
JC: Cell and gene therapies aren’t like the medicines most of us will be familiar with. Research, manufacturing and supply chains are very complex and require specialist skills, and bespoke infrastructure is needed to deliver them. If we are to get this right, and ensure rapid patient access, different stakeholders will be required to work together seamlessly.
One area of collaboration that is core to the Collective is with patient organisations. If we are to retain the UK’s world leadership in cell and gene therapy and help convert it into tangible patient benefit in the NHS, the patient voice is crucial. Patients are not passive recipients in this journey, they want to be part of the pioneering journey, whether that be through participation in clinical trials or inputting to access policy discussions.
The UK has been pioneering in adopting cell and gene therapies which represent a valuable potential option for people with devastating diseases, such as end stage cancer. There are a small number of therapies approved already, and the total number of cell and gene therapy clinical trials in the UK has been increasing consistently over the past few years, including a growth in late-stage clinical trials . Over the next 10 years, we hope that the UK will remain a global leader in access to cell and gene therapy, with this kind of innovation to potentially make a meaningful difference to the lives of people in a variety of disease areas. Collaboration between researchers, universities, the pharmaceutical industry, regulators and patient organisations will be key to making this happen.
LR: What does Gilead bring to this initiative?
JC: Through its specialist company Kite, Gilead is a leader in CAR T cell therapy both in clinical research to develop therapies across multiple indications and as a partner to the NHS, in establishing specialist centres to accelerate access to these innovative therapies for patients.
We also invest in researching hard to treat haematological malignancies and solid tumours, exploring new allogeneic CAR T cell products using gene editing technology. The new approach would support a more immediate availability of product and simplify manufacturing logistics, enabling faster treatment and expanding access so more eligible patients can receive therapy.
We’re so pleased to be part of this initiative alongside industry leading companies Astellas, bluebird bio, Bristol Myers Squibb, GSK, Janssen, Novartis and Roche who are all working to develop cell and gene therapies across a broad range of diseases where there is currently a high unmet need. We are a small community and there is value in working together on the key issues facing the sector.
LR: Why do we need to draw more attention to cell and gene therapy in the UK and how does the sector compare with other countries?
JC: As the science of cell and gene therapy develops and these technologies are applied to a greater number of conditions, novel models of care will need to be developed and potentially innovative ways of accessing value established. Through sharing our experience across companies, we hope to be constructive partners to the NHS and other stakeholders in helping ensure the UK remains a leading hub for cell and gene therapy innovation, to attract investment into R&D, and ensure people in the UK continue to be among the first to access the innovation these therapies represent.
We want to work with the government and healthcare systems to increase their understanding of the potential of cell and gene therapies and to take steps together to ensure patients benefit from approved treatments at scale in the future.
Internationally, Europe has the second largest regenerative medicine ecosystem in the world with 400 plus companies related to regenerative medicine. The UK is at the forefront of research and translation development, with nearly one in three businesses active in Europe’s advanced therapy medicinal product market are based in the UK. Additionally, there was an increase of almost 30% in commercially sponsored clinical trials and a 20% uplift in the reported number of clinical trials in the UK in 2020, demonstrating the ongoing potential of the UK as an attractive destination for medical research and international leader in standards of care.
LR: What are the challenges that this area of research and drug discovery faces and how can they be overcome?
JC: Often, these innovative treatments are for very rare diseases with small patient populations and limited alternative treatment options, which impacts the ability of organisations to conduct traditional large-scale randomised clinical trials – therefore, all stakeholders need to work together to find and agree new ways of assessing efficacy, safety and cost effectiveness.
LR: Where are the opportunities in cell and gene therapy in the UK and globally?
JC: By 2035 it is expected that the industry could be worth £10 billion and provide 18,000 jobs. From a Gilead perspective there is a need to continue to invest in improving the efficacy and safety of existing therapies. We are also researching hard to treat haematological malignancies and solid tumours, exploring the use of gene editing technologies in products including new allogeneic CAR T cells.
Volume 22, Issue 4 – Fall 2021
Julian Cole is the Country Medical Director of Gilead Sciences for the UK and Ireland. He qualified in medicine at King’s College London, has over 25 years of experience in the pharmaceutical industry, and is a Fellow of the Faculty of Pharmaceutical Medicine and a Global Fellow in Medicines Development.