Q&A: The new Innovation Hubs for Gene Therapy
On 22 November, UK Advanced Therapies (UKAT) organised a webinar, hosted by MedCity, to introduce the advanced therapies network across the UK to the three Innovation Hubs for Gene Therapies. The Hubs are jointly funded by the UKRI Medical Research Council (MRC), LifeArc and UKRI Biotechnology and Biological Sciences Research Council (BRSCC).
The event is now available to watch back, but to provide an overview of the Hubs and what they will offer for spinouts, start-ups, researchers and industry, we brought together Dr Sophie Mountcastle, Network Manager, Innovation Hubs for Gene Therapies (on behalf of MRC and LifeArc) and Francesca Gliubich, Director of Skills & Training for the London Hub. Francesca is also Director of UK Advanced Therapies, which consolidates research activity in cell and gene therapy across the nation.
Q: Sophie, can you tell us about the background to the Hubs?
The Hubs grew out of a collective request from the UK advanced therapies community, that we do something to address a bottleneck − identified by both industry and academic researchers − in moving academic gene therapy product innovation to patients.
Researchers in particular find it really challenging to secure clinical grade materials to progress their therapies to early phase clinical trials, especially when targeting specific indications such as the eyes, for which commercial suppliers aren’t generally willing to supply such small amounts of material. So academic researchers were finding that their manufacturing slots were pushed back suddenly, or cancelled, as larger commercial orders are more attractive to manufacturers. Many were having to go overseas to source their materials for clinical trials, and obviously that’s not ideal for the UK sector.
Recognising this, the academic and commercial gene therapy community came together to give funders a clear message that, actually, this is a real need. We don’t have this capacity in the UK. So, MRC and LifeArc committed £18 million over five years, to fund three new manufacturing centres that would provide dedicated resource for academics who need clinical grade factors for their gene therapy clinical trials.
The network of three manufacturing Hubs was launched in 2021 – NHS Blood and Transplant at Filton, just north of Bristol; the University of Sheffield; and the London Hub is a collective, formed by King’s College London, UCL and the Royal Free Hospital. Alongside the manufacturing facilities, the Hubs will have a remit to provide advice and translational guidance for academics, who quite often struggle to get that type of tailored support for their projects from commercial suppliers.
Q: At the event last week, it was really clear that each of the Hubs across the UK has their own strengths. Could you give us an idea of the differences between the Hubs and how they’ll work together?
The University of Sheffield Hub is part of a brand-new building that the university has funded and completed this year. The Sheffield Hub focuses on Adeno-associated virus (AAV) manufacturing and process innovation for AAV. Then the NHSBT Hub in Bristol will also have a similar AAV platform. They’re also quite unique though, in having a direct link into the healthcare system and they’ve been manufacturing Good Manufacturing Practice (GMP) materials for over 20 years, such as plasmids and cells for cell therapy. So, they’ve got a lot of GMP experience that they can contribute to the network.
Both Sheffield and Bristol are working with the same manufacturing process, but will most likely specialise in slightly different disease indications.
The London Hub brings small-scale manufacturing expertise to the network, particularly through the manufacturing facility at Kings, which has been producing lentivirus for many years for academics. What we’ve funded as part of the Innovation Hubs, is an expansion of their lentiviral facility, that can accommodate more academic projects, and also the establishment of an AAV platform. This will be an alternative adherent platform, which is distinct from the suspension platform that Bristol and Sheffield have.
The capabilities of each Hub will be complimentary, so that researchers who come into the network will have access to two different types of AAV processes and lentivirus. Obviously, they’ve all got their own individual sites and staff, but we have committees with representatives from all three Hubs on them, to enable knowledge sharing and problem solving. We have a skills committee, a process development committee, and a coordinating committee, on which all the Hub directors sit. We also have a project management group, with representatives from all the Hubs, that has oversight of where each Hub is, in terms of their timescales and delivery, how they can support each other with procurement, how they can work together to negotiate better supplier costs, and so on.
The funders really wanted a network, rather than siloed sites, because the three Hubs all bring slightly different expertise, and being able to share that, and build on that, is really important to address some of the challenges that still exist within advanced therapy manufacturing.
Q: We know from our Demand Report that the London start-up community in gene therapy struggles to access manufacturing space and expertise. What services will be on offer for early-stage companies?
The Hubs offer the same services to SMEs as they do to academic projects. We can provide manufacturing if they’re developing a gene therapy, for example, and if they need clinical grade material, we can provide that as a service. If companies are developing manufacturing processes, the Hubs would be very interested to work with them on that as well. We can also provide translational advice and support, guidance on where to go next for funding, and how to engage with regulators. Having LifeArc on board is really useful as well, because they have a lot of expertise in raising capital.
We talk about the network being the three Hubs, but, actually, we’re envisioning it being a lot broader than that. Engaging with industry, engaging with SMEs, and having them involved in the network is really important. We’re very keen to collaborate and work with industry at all levels and all scales.
One of the things we are currently looking at is establishing an industry advisory group for the network, in order to develop an understanding of what key industry players are doing in the space. We want to build relationships with larger commercial suppliers as well, so that we can support early-stage innovators who use the Hubs − or work with the Hubs − in navigating commercialisation pathways.
Q: The skills agenda is also part of the remit for the Hubs. Francesca, can you tell us more about that?
The three Hubs are all working together to address the skills gap in UK cell and gene therapy. We can divide what we are doing into three major components.
Firstly, we will be creating educational packages, including Masters degrees and short courses. And, in order to ensure we do this in the best way, we are also running a scoping exercise to understand what the need is. We’ll be presenting the outcome of our consultation at the next UKAT event early next year, and inviting feedback from the community, because we want to make sure that we develop what is needed, not something that may have already been done.
Secondly, we have developed a model around the concept of a national trainer on manufacturing process to provide advice to the other networks if anyone incurs a problem when developing a protocol.
Thirdly, there will be channels for knowledge sharing across the networks to overcome obstacles. These might be things that you get stuck on in the lab for weeks, and you may need to change one small thing that will make the difference. You could say, we will be teaching each other, and then together we can teach the world!
Q: The UKAT event last week outlined the apprenticeships that will be on offer. From the MedCity perspective, we’re especially interested in opportunities that will be made available to local communities who don’t have an academic background. Sophie, could you give an overview of what the Hubs will provide in that regard?
Yes, so alongside structured academic courses like masters and PhD, the Hubs will cover the whole breadth of ways in which people might want to engage and learn. This encompasses apprenticeships at all levels and vocational training, as well as the short courses that Francesca mentioned, to help communities stay up-to-date with the latest developments, and also provide teaching modules on fundamental concepts that people coming into the industry from elsewhere would need to know. So, there is a really broad range of skills activities that the network is building, and working together to deliver.
PARTICIPATE IN THE CONSULTATION
Please help: If you are working in this space, we would be grateful for your input by completing this short survey, run by the Innovation Hubs for Gene Therapies, to assess the needs of the UK advanced therapies community. The survey is open until 31 January 2023, and the Hubs are keen to hear from the community about the vectors and disease-indications you are working with.
The outcome will be presented at the next UKAT event in early 2023. Look out for details in future newsletters and through our social channels.
Sophie Mountcastle, BSc, MSc, PhD (She/Her)
Network Manager, Innovation Hubs for Gene Therapies / Medical Research Council
As Network Manager, Sophie coordinates the network of Innovation Hubs for Gene Therapies, working with the teams at each of the three Hubs and the funders, to deliver communications, skills and training, and stakeholder engagement activities. Sophie is also responsible for supporting governance of the Innovation Hubs, including monitoring of progress and project management support, and providing the secretariat for the oversight committee. She has previous experience of managing investments on behalf of the Medical Research Council (MRC), as Science Manager for the UK Regenerative Medicine Platform. Sophie also supports MRC and LifeArc funding schemes and strategic activities for clinical and translational medical research.
Francesca Gliubich, Director of UKAT
Francesca is the Director of UK Advanced Therapies (UKAT), established in 2021 following the expansion of the London Initiative (London Advanced Therapies) to a UK-wide network of regional networks. She is also the Chief of Staff (Health & Life Sciences), at King’s College London.
Previously, Francesca was Director of Grants at Barts Charity and Head of Strategic Development at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. Francesca also has commercial experience, having worked both in business development and technology transfer within academic and commercial settings, both in the UK and overseas. Her academic background includes a MRes degree in Industrial Chemistry, a PhD in Structural Biology, in addition to being an awardee of EMBO and EU Marie Curie research fellowships. Outside academia, Francesca is the Chair of Trustees of the British Fencing Charity and recently joined the Board of British Fencing.