I’m thrilled to sit down with Ivan Kairatov, a renowned expert in biopharma with a wealth of experience in research and development, particularly in the rapidly evolving field of cell and gene therapies (CGTs). With his deep knowledge of technology and innovation in the industry, Ivan offers unique insights into how large biopharma companies are driving the future of these groundbreaking treatments. In our conversation, we explore the pivotal role of big biopharma in scaling CGT development, their expansion into new therapeutic areas beyond oncology, the critical infrastructure challenges they face, and the ongoing efforts to improve patient access through innovative commercial models.
How do you see big biopharma companies shaping the future of cell and gene therapies compared to smaller firms?
Big biopharma companies are really becoming the backbone of CGT advancement. They have the resources, long-term vision, and global reach that smaller firms often lack. While smaller companies are incredibly innovative and often pioneer early-stage breakthroughs, they frequently hit roadblocks when it comes to scaling up or navigating the complex regulatory and commercial landscapes. Big biopharma can step in with their financial muscle and established infrastructure to take these therapies from promising concepts to widespread treatments, ensuring they reach patients who need them most.
What unique strengths do large biopharma companies bring to the table when it comes to scaling up CGT development?
Their strengths lie in their ability to operate at scale across multiple dimensions. They’ve got the capital to invest in cutting-edge research and massive manufacturing facilities, which are essential for producing therapies at the volume required for broader markets. Additionally, they have experience in navigating complex regulatory pathways worldwide and can leverage their established networks with healthcare providers and payers to streamline commercialization. This kind of end-to-end capability is something smaller players often struggle to replicate.
Can you explain how the financial power of big biopharma helps overcome funding challenges in this field?
Absolutely. The CGT space often faces what’s called the “valley of death”—that critical gap between early research and late-stage development where funding dries up. Many promising therapies stall here because smaller companies or startups can’t secure the capital needed for clinical trials or scaling production. Big biopharma can bridge this gap with their deep pockets, providing the sustained investment necessary to push therapies through to approval and beyond. This financial stability also gives confidence to smaller partners who rely on these collaborations to survive.
How are big biopharma companies expanding the applications of CGTs into areas beyond cancer treatment?
We’re seeing a fascinating shift where companies are leveraging their success in oncology to tackle other high-need areas. For instance, they’re applying CAR-T therapies—originally developed for blood cancers—to autoimmune conditions like lupus and rheumatoid arthritis, as well as neurological disorders such as multiple sclerosis. The idea is to use the same principles of modifying immune cells to target disease-specific mechanisms in these new areas. It’s a bold move, driven by the recognition that the underlying technology has potential far beyond its initial scope.
What specific challenges arise when adapting CAR-T therapies to conditions like lupus or multiple sclerosis compared to oncology?
The challenges are significant because the biology of these diseases differs vastly from cancer. In oncology, CAR-T therapies target malignant cells that are often easier to identify and attack. In autoimmune or neurological conditions, the targets are less clear, and there’s a higher risk of off-target effects or immune overreactions. Additionally, the patient populations are different—often younger or with chronic conditions requiring long-term management—so the treatment protocols, delivery methods, and even safety profiles need to be rethought to fit these contexts.
What are some of the biggest manufacturing hurdles for CGTs, and how are large biopharma companies addressing them?
Manufacturing CGTs is incredibly complex due to the personalized nature of many therapies, like autologous CAR-T, where cells are taken from and returned to the same patient. Consistency, quality, and cost are huge hurdles. Big biopharma is tackling these by investing heavily in state-of-the-art facilities and process improvements. They’re focusing on automation and standardization to improve reproducibility and drive down costs, while also developing platforms that can speed up production timelines to get therapies to patients faster.
How does the scope of big biopharma operations give them an edge in addressing infrastructure needs for CGT development?
Their sheer size and scope allow them to operate on multiple fronts simultaneously—research, manufacturing, regulatory, and commercialization. Smaller companies often have to prioritize one area at a time due to limited resources, which can slow progress. Big biopharma can integrate these efforts, ensuring that advancements in one area, like manufacturing, directly support another, like clinical development. This holistic approach is critical for overcoming the infrastructure bottlenecks that have historically plagued CGTs.
What are the main barriers to making CGTs accessible to a wider range of patients, and how are companies working to solve these?
Patient access is a massive challenge due to logistical and financial barriers. Many therapies require patients to travel long distances to specialized centers, which can be a huge burden, especially for those with chronic conditions. Then there’s the cost—CGTs are often prohibitively expensive. Big biopharma is working on solutions like developing outpatient treatment models to reduce the need for hospital stays and educating community-based doctors to bring care closer to patients. They’re also exploring new payment models with insurers to make these therapies more affordable.
What is your forecast for the future of cell and gene therapies over the next decade?
I’m incredibly optimistic about the next ten years for CGTs. I believe we’ll see these therapies become more mainstream as manufacturing processes improve and costs come down. We’re likely to witness a surge in applications beyond oncology, with breakthroughs in autoimmune and neurological diseases changing lives for millions. Big biopharma will continue to play a central role, driving innovation and access, but partnerships with smaller innovators will remain crucial. If we can solve the access and affordability puzzles, CGTs could truly redefine how we treat some of the most challenging diseases out there.
