What was your biggest professional highlight of the past 12 months?
My biggest professional highlight has been opening the AERIAL phase 1/2 basket trial of LEU011, our autologous CAR T-cell therapy for patients with NKG2D ligand-expressing solid tumors. Moving a program from scientific concept through the translational, regulatory, manufacturing, and clinical steps needed to open a trial is a major milestone and reflects the work of a large multidisciplinary team.
What makes this especially meaningful is seeing years of immunology, cell therapy development, and clinical collaboration begin to translate into patient care. In CAR T-cell therapy, success depends not only on scientific innovation but on turning that science into carefully designed clinical studies.
What is the biggest bottleneck slowing progress in the cell and gene field right now - and how do we fix it?
The biggest bottleneck is not scientific imagination; it is delivery. As a field, we have extraordinary ideas, but too many therapies remain slow, complex, expensive, and difficult to manufacture at scale. In autologous cell therapy especially, vein-to-vein time, manufacturing variability, release testing, logistics and cost all limit impact.
My firm view is that we need to remove as much unnecessary human intervention and manual paperwork from the process as possible. These therapies are already biologically complex; we should not add avoidable operational complexity on top. Every manual handover, paper-based check, and disconnected system introduces delay, cost and risk.
The solution is to invest much earlier in scalable manufacturing platforms, automation, digitalization, closed-system processing, integrated data capture, and robust quality systems. We also need closer alignment between academic innovators, manufacturers, regulators, and health systems, so that promising therapies are designed from the outset with delivery, reproducibility, affordability, and patient access in mind.
If we want cell and gene therapies to move beyond highly specialized settings and reach patients at scale, we have to treat manufacturing and delivery as central scientific and clinical challenges - not as downstream operational details.
Where is the cell and gene industry making real progress that isn't getting enough attention?
I think we are making underappreciated progress in understanding why therapies fail. The field has rightly celebrated dramatic responses, but equally important is understanding why therapies fail. The quieter advances are in dissecting resistance, antigen escape, T-cell exhaustion, tumor microenvironment suppression, and host immune factors.
We're also seeing meaningful advances in vector design, nonviral engineering, closed-system manufacturing, in vivo approaches, and rational combination strategies that should make these therapies more practical and durable.
What's one widely held belief in your field that you disagree with - and why?
Regulators often argue, with some justification, that their statutory remit is quality, safety and efficacy - not price, reimbursement, or affordability. EMA, for example, states that it has no role in pricing and reimbursement decisions, and FDA states that it has no legal authority to control drug prices. I understand the legal distinction, but I disagree with the implication that regulatory decisions are therefore neutral with respect to cost and access. In cell and gene therapy, regulatory expectations around manufacturing, comparability, release testing, evidence generation and post-authorization commitments can profoundly affect cost of goods, operational complexity, and the number of centers able to deliver a therapy. So, while regulators may not set the price, they absolutely help shape whether a therapy can be developed and delivered in a way that is scalable and equitable.
My view is not that standards should be lowered. Patients must be protected, and advanced therapies need rigorous oversight. But regulation should be proportionate, science-led, and explicitly conscious of its downstream consequences for access. Regulators are public bodies, and their role should include enabling responsible innovation - not only preventing unsafe or poor-quality products from reaching patients, but also helping ensure that transformative therapies can realistically reach the patients who need them.
Cell and gene therapies should not become medicines only for the few. If regulatory frameworks unintentionally make development so complex and expensive that only the best-funded organizations can participate, or only a narrow group of patients can benefit, then we need to ask whether the system is serving the public interest as well as it should.
What's the smartest way to navigate today's funding and commercial landscape in cell and gene therapy?
The smartest approach is to be brutally clear about the translational path from the beginning. Strong science is essential, but it is not enough. Funders, partners, and commercial teams increasingly want to know not only whether a therapy can work, but whether it can be manufactured reliably, delivered efficiently, reimbursed sustainably, and clearly differentiated from existing or emerging alternatives.
That means building programs around compelling biology, a genuine unmet clinical need, scalable manufacturing, realistic cost of goods, and early engagement with regulators, payers, clinicians and patients. In the current environment, products and platforms that solve real-world implementation problems are likely to be more attractive than scientifically elegant concepts that are difficult to manufacture, deliver, or fund.
Simplicity should be a core strategic goal. Cell and gene therapies are inherently complex, so we should constantly challenge ourselves to simplify the design, manufacturing process, release testing, logistics, and clinical delivery wherever possible. The best programs will be those that combine biological innovation with practical deliverability – because in this field, a therapy only fulfills its promise if it can actually reach patients.
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