Pharmaceutical manufacturing for cell and gene therapy is a tripod. Its three legs are academia, business, and the nation. If you remove one leg, it will fall. Without university laboratories, there is no single treatment for the market. And cell and gene companies cannot perform at their best without state support from institutions such as the UK’s Cell and Gene Therapy Catapult. We can expect these things to remain true for the foreseeable future.
But if funding worked differently, I think the academic leg could stand on its own longer. It means you can’t raise £10,000. This is where the private sector steps in, transforming pure science in academia into viable IP.
Conversely, I do not believe that the private sector can be completely self-sufficient. Some big pharma companies are setting up cell therapy development teams, but I would expect these companies to be far more likely to release new versions of existing products than truly new treatments. This is where business requires academics.
I believe that the sooner we can figure out how to allocate industry funding to academic programs, the faster the field can develop. If we could get big pharmaceutical companies to fund bakeries instead of buying bread, we could cut years off the development process.
I certainly don’t claim to have all the answers to very difficult and inflexible problems, but I do advocate building new and better bridges between pharmaceutical and academia. I am living proof.
If we could get big pharmaceutical companies to fund bakeries instead of buying bread, we could cut years off the development process.
He started his academic career in 1999 with a Master’s Degree in Research from the University of Birmingham, UK. I stayed on to complete my PhD on how chemokines cause inflammation and inflammatory liver disease. We are studying monocytic myeloid cell biology with the aim of developing dendritic cells as a primary therapy for liver cancer. It was this job that first got me into a cell therapy program. That eventually led to my first involvement in a cell therapy trial to treat late-stage liver cancer with a dendritic cell vaccine. The trial met its goals and ended during the COVID-19 pandemic, ultimately yielding positive results.
For the past five years I have taken over the running of GMP activities across the University of Birmingham. We have grown from a small self-closed facility into a facility with a wide variety of academic and commercial partners. doing.
Adding commercial viability to academic centers can transform the offer to early-stage startups. This is where academic CDMOs tend to get bogged down. They were not designed with commercial issues such as speed or contracts in mind. Aligning with the right commercial partners can facilitate a smooth transition from academic programs to the world of privately funded cell therapy trials.
In its role at the university, it is expected to make its current facilities break-even, but will not be forced to return profits to shareholders.
As a sector, academic CDMOs need to show a way out for those in the rut of trying to build cures entirely on subsidies. After all, the grant-winning move is usually not the move that helps launch a robust and sustainable business. We need to free these people from the urgency of reinventing the wheel on a regular basis just to keep moving forward.
In the case of my own company’s transition to the market, I don’t see much change in the basic functionality of a development-focused CDMO. We will continue to work with our commercial partners and focus on how they can complement our academic programmes. We’ve seen the Catapult take academic programs and continue to make impressive capital investments. Hmm. In many cases, a company’s processes require costly development, but it’s too late once the company has already moved into rental manufacturing space.
A sensible commercial partnership should help facilitate such a transition. We need to leverage the proximity of academic CDMOs to patient care centers and the pool of key opinion leaders in centers of clinical excellence. Our goal is to work closely with early stage therapeutic developers to get products and processes right the first time.
The initial cost of setting up this joint venture will pay for itself in the future if we can create a network of academic centers with appropriate industry partnerships.
A skeptic might ask: Won’t unions with commercial partners raise new problems of trading the game of academia for the game of business? All I can say is that if you pay attention to establishing key partnerships you can still make a difference for your patients. But the right market exists and is receptive, as evidenced by the sector’s ongoing acceleration. In its role at the university, it is expected to make its current facilities break-even, but will not be forced to return profits to shareholders. Developing a commercial strategy changes my job, but I don’t see it as a big challenge.
One factor that needs to be considered is scale. Operating a GMP facility is very expensive and academic CDMOs need to take advantage of economies of scale to make a profit. The initial cost of setting up this joint venture will pay for itself in the future if we can create a network of academic centers with appropriate industry partnerships. For example, some degree of leadership and quality monitoring can be achieved remotely, so these elements can be distributed across the network rather than being duplicated on every node. Therefore, the larger your network, the more you can dilute these aspects of running costs.
Decentralized networks are also suitable for providing self-medication to patients, as they help avoid the current situation. Now we ship materials thousands of miles to factories and then ship them again. This is bad economic practice, bad environmental practice, and adds unnecessary high risk to the process.
Companies like mine must play a key role in providing GMP manufacturing for clinical development of post-subsidy cell and gene therapy. We want to provide a bridge of manufacturing offerings to smaller institutions that want to develop cell and gene therapies but do not have the resources or need to engage in large-scale CDMOs. This will enable more cell and gene therapies from more specialized tissue groups to progress to the clinic, reaching an even broader group of patients than could benefit from therapies currently in development. There is likely to be.
Head of Business and Project Development – Advanced Therapeutics, University of Birmingham, UK
