The chief executive of Ori Biotech explains why personalised medicines hold the promise of dramatically improved efficacy and safety.
Ori Biotech is a global leader in cell and gene therapy manufacturing technology and chief executive Jason Foster is a recognised thinker and speaker in the field. Here, he talks to Healthcare Today about the evolution of personalised therapies and precision medicine, where to look for innovation in the field and, crucially, how to get it funded.
Healthcare Today: What role do you see personalised therapies and precision medicine playing in the future?
Jason Foster: The vast majority of medical interventions available today can be described as “generic” – not in the sense of generic medicines, but in their broad applicability. This generalised approach, however, often results in limited efficacy. Statistically, the proportion of patients who respond positively to these interventions is frequently below 50%.
One of the primary challenges is our limited ability to predict which patients will respond to which treatments. In the absence of more precise tools, healthcare providers rely on what is often referred to as a “shotgun approach,” administering treatments broadly across patient populations. While this method has been the norm for the past 20 to 30 years and is certainly better than no intervention, it is far from optimal.
We are now witnessing a significant shift toward personalised medicine – an emerging approach that tailors medical treatments to the unique characteristics of each patient. This has profound implications for the pharmaceutical supply chain, medical practice, and healthcare delivery. By focusing on the specific needs of individual patients, personalised medicine holds the promise of dramatically improved efficacy and safety.
A compelling example of this transformative potential can be seen in CAR T-cell therapies. These treatments, designed for oncology patients, already demonstrate success rates exceeding 90% in achieving complete responses. The patients who benefit from these therapies are often at advanced, refractory stages of illness, having failed traditional interventions such as chemotherapy and, in many cases, bone marrow or stem cell transplants. For these critically ill patients, CAR T-cell therapy often represents their last hope, and the results are nothing short of extraordinary.
But this shift to personalised treatments brings its own set of challenges, particularly in making these highly specialised treatments widely accessible. The question then becomes: how do we ensure that personalised medicine is not only effective but also available to all patients who need it?
“Traditional pharmaceutical supply chains are designed for broadly applicable treatments. Personalised medicine disrupts this model entirely.”
Healthcare Today: These solutions face huge challenges in scalability and cost. How do you bridge that gap?
Jason Foster: The cost of developing personalised medicines is indeed significant, with estimates suggesting it takes between $1 billion and $2 billion to bring a single pharmaceutical product to market. While personalised medicines are somewhat more expensive to develop than traditional treatments, the greater challenge lies not in their cost but in the complexity of their production and delivery. Traditional pharmaceutical supply chains are designed for broadly applicable treatments. Personalised medicine disrupts this model entirely. When a treatment is tailored to a single patient, the supply chain must be reimagined.
Addressing this challenge requires a fundamental shift in how we think about pharmaceutical manufacturing and delivery. It often involves a “circular supply chain,” where the process starts with the patient. For example, a patient’s immune cells might be collected at a hospital and transported to a manufacturing facility. There, they undergo a complex series of processes before being returned to the patient as a finished therapeutic product. This cycle, from start to finish, typically takes six to twelve weeks or more.
These therapies are not only personalised but often living medicines. Unlike chemical or biological treatments, living cell therapies come with unique considerations. Cells must be carefully preserved, unlike relatively stable chemical compounds. This adds layers of complexity to every stage of the process.
The cost of these therapies reflects their intricacy. Cell therapies, for instance, range from $400,000 to $500,000 per patient, while gene therapies can cost up to $5 million per patient. Despite these high prices, cost alone is not the primary barrier to wider adoption. Even if prices were reduced to zero, the physical capacity to manufacture these treatments would still be a limiting factor. The processes involved are difficult, resource-intensive, and constrained by the unpredictability of biology.
This lack of manufacturing capacity is particularly evident with CAR T-cell therapy, the first generation of cell therapies. In the US, only 20% of eligible patients have access to these treatments. Globally, this figure drops below 5%.
To address these issues and expand access to personalised medicine, we need to innovate on multiple fronts. Better systems, advanced technologies, and new approaches to manufacturing and distribution are essential to driving the next wave of innovation. With these advancements, we can strive to make personalised medicines as accessible as traditional small molecules and biologics, transforming healthcare for patients worldwide.
Healthcare Today: How significant is the regulatory issue?
Jason Foster: The phrase “regulatory innovation” is not one we often hear – it almost sounds like an oxymoron. However, during the Covid-19 pandemic and its aftermath, we witnessed an extraordinary level of regulatory innovation. In just a year, five or six new therapies and vaccines reached the market – an unprecedented feat made possible by regulators addressing the acute global need with remarkable agility.
In the US, leaders like Peter Marks [director of the Center for Biologics Evaluation and Research] have been particularly open and innovative in facilitating patient access to these therapies. The Food and Drug Administration (FDA) implemented measures like fast-track reviews and the integration of Phase One and Phase Two clinical trials. These unprecedented actions underscored the regulator’s commitment to bringing novel treatments to patients without compromising safety or efficacy.
A few years ago, we had the opportunity to meet with the FDA, including Peter Marks and his leadership team. Their interest in our work was clear, as they understood the ultimate goal: to ensure that approved products reach patients who need them. While patient safety and treatment efficacy remain paramount, regulators are increasingly embracing innovation to expedite access to advanced therapies.
Consider the traditional model of pharmaceutical manufacturing. For decades, it has been a centralised process: a large facility produces medications or biologics, which are then packaged and distributed through the supply chain. But this model is not well-suited for personalised medicine. For example, if a patient’s cells are collected in the UK and need to be shipped to a manufacturing site in the US, only to be processed and flown back, the inefficiencies in cost, time, and logistics are glaring.
Regulators such as the FDA and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) are exploring a decentralised approach to manufacturing. This involves smaller, localised manufacturing sites that can produce treatments closer to the patient, reducing what is called “vein-to-vein” time – the period from when a patient’s cells are collected to when the treatment is delivered back. Both agencies have issued guidance and sought public input on distributed manufacturing.
While regulators have shown strong support for advanced therapies, significant challenges remain. Chief among them is the need for new technologies to underpin these innovations. The current infrastructure is insufficient to execute distributed manufacturing effectively. Cloud-based systems, advanced manufacturing technologies, and other innovations are essential to delivering safe and effective medicines in this way.
The potential is vast, but realising it requires sustained effort, investment, and technological breakthroughs.
“Automation, including robotics, is crucial to reduce costs, improve quality, and remove human error from the process.”
Healthcare Today: You mentioned innovation during Covid. Have we taken on board those lessons or have we slipped back into our old ways?
Jason Foster: Encouragingly, a bit of the openness and flexibility fostered during the Covid-19 pandemic is still evident, but there are signs of bureaucracy creeping back in.
For example, I recently spoke with a hospital-based manufacturer in Europe with a long history of producing CAR T-cell therapies in-house. Over the past seven years, they’ve successfully treated more than 500 patients with their own CAR T-cell product and they were exploring the possibility of licensing this treatment to countries where access to CAR T-cell therapies is currently limited or non-existent.
Unfortunately, the licensing process hasn’t been quick and straightforward. Despite their proven track record, the company is being required to navigate the conventional regulatory process, which is time-consuming and costly. This process could take years and require tens of millions of euros, delaying access for patients in other countries who could benefit from this already validated treatment. It’s a frustrating situation, especially when lives are at stake.
Healthcare Today: What innovations are you most excited about looking into 2025?
Jason Foster: One significant trend in cell therapy is the shift from viral transduction to non-viral transfection techniques for genetic modification. While viruses are efficient at delivering DNA into cells, their manufacturing and handling are complex and costly. Consequently, methods like electroporation are gaining traction as alternative delivery mechanisms. This trend is expected to continue due to the high cost and manufacturing complexity of viral vectors.
Another key area of development is automation. Current cell therapy manufacturing processes often rely on manual lab techniques, making scaling to GMP (Good Manufacturing Practice) grade extremely challenging. Automation, including robotics, is crucial to reduce costs, improve quality, and remove human error from the process. Platforms designed with this “second layer” of automation in mind – automating beyond initial bottlenecks – will be key to industry advancement.
Finally, the application of AI and machine learning is a major emerging trend. The cell therapy industry currently holds vast amounts of data, much of it unstructured and on paper, making analysis difficult. Digital, cloud-native platforms are essential to capture, structure, and aggregate this data. This allows for in-depth analysis and the development of predictive models. For example, when a batch fails quality control, AI can help pinpoint the cause, moving beyond simple explanations like “patient variation”. These tools can also personalise treatment approaches based on patient characteristics and process variations, ultimately improving patient outcomes. The potential of AI is significant, with the possibility of accelerating drug development timelines by approximately three years, speeding up both clinical development and the transition to commercial-scale manufacturing.
This is just the beginning of what these digital tools can achieve.
