Dr. Boro Dropulic: Gene Therapy Cost Reduction

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/12/01

Dr. Boro Dropulic is a biotech veteran and executive director of Caring Cross. He spearheads a revolutionary initiative to reduce gene therapy costs by up to 90%, making life-saving treatments significantly more affordable and accessible to millions. In partnership with Brazil’s Fundação Oswaldo Cruz (Fiocruz), Caring Cross has implemented a decentralized manufacturing model that produces gene therapies directly at the point of care, reducing CAR-T therapy costs from $373,000 to as low as $35,000. This approach has already succeeded in India and Spain. Boro is excited to explore its potential to transform global healthcare.

Dropulic talks about reducing gene therapy costs by up to 90%. Dropulic explains how they are developing more affordable CAR T-cell therapies by cutting material and manufacturing costs, establishing decentralized point-of-care models, and collaborating with organizations like Fiocruz in Brazil. They aim to make therapies accessible globally, including in low-income countries, by leveraging local resources and efficient workflows. Dropulic expresses personal fulfillment from helping improve patients’ lives.

Scott Douglas Jacobsen: Today, we are here with Boro Dropulic. We are going to be discussing Charing Cross. As a biotech veteran and Executive Director of Caring Cross, I want to explore some of its new work, particularly the framework initiative to reduce the cost of gene therapy. The claim is that costs could be reduced by up to 90%. At face value, many gene therapy treatments can sound expensive, as they may seem like futuristic technology akin to something out of Star Trek.

When you propose a gene therapy cost reduction of up to 90%, what benchmark are you using for comparison, and how are you achieving such significant cost reductions? What is the scope of this reduction?

Dr. Boro Dropulic: Thanks for the invitation, Scott. It’s a pleasure to be here and to share what we are doing at Caring Cross.

Caring Cross has been a group of scientists and individuals in the field for many decades. What we’ve found is that the prices are extraordinarily and unnecessarily high. For example, the current price for some CAR T-cell therapies is around $350,000 to $475,000. Some stem cell gene therapies can range from $2 to $3 million for a single dose, not including the clinical costs.

Our approach to solving this problem is to reduce the cost of manufacturing, materials, and distribution, making these therapies more accessible to patients who need them. The first major factor is the cost of materials. Producing CAR T cells involves extracting cells, genetically modifying them with a vector, and then reintroducing the modified cells into the patient. These cells can then kill tumours or infected cells or replenish a defective gene. One of the biggest expenses in this process is the vector itself. Reducing the cost of producing these vectors can greatly lower the overall cost.

To tackle this, we created a public benefit corporation called Vector BioMed  that produces these vectors at about half the cost. In some cases, the costs are even lower, making producing these therapies more affordable.

In addition, we’ve simplified and shortened the workflows to produce the cell products. Typically, it takes 14 days or longer to produce CAR T cells. Still, we’ve managed to reduce that to 7 days and aim for a process that can be completed in a single day. We can significantly reduce costs by shortening the production time and simplifying the process while keeping it robust.

Another way we are addressing the high costs is by moving away from large, centralized manufacturing facilities. Currently, autologous cells are sent from hospitals to manufacturing facilities over long distances, produced there, and then returned. This process requires substantial logistical, manufacturing, and insurance costs. Maintaining such largefacilities, with fluctuating demand, is expensive.

Our alternative is a point-of-care manufacturing model, where smaller, flexible, and scalable facilities can be deployed near hospitals where patients receive care. This approach significantly reduces labour and logistical costs.

In summary, these are some of the strategies we’re using to achieve lower price points. Additionally, producing the therapies locally and within a shorter timeframe offers significant benefits to patients.

Scheduling is easier for clinicians, patients receive their products much quicker than expected, and patient outcomes significantly improve. We published a study several years ago where we definitively showed, in a publication, that the vein-to-vein times, as we call them, can be significantly reduced, resulting in better patient outcomes. Also, this decentralized or point-of-care manufacturing model is already operational in Spain. There is a group led by a hospital in Barcelona that now has ten clinical centers producing their own CAR T-cell products across Spain, doing so at a cost affordable for the Spanish National Health Insurance System—around €89,000 per dose.

Jacobsen: It’s not one-tenth of the cost, but it’s certainly much more affordable than $400,000. Now, you’ve focused on treatments for leukemia, lymphoma, HIV, and sickle cell disease. Why focus on those particular conditions in terms of therapy development?

Dropulic: These are all serious diseases with unmet needs. For leukemia and lymphoma, current CAR T-cell products are initially effective at generating a good response, but about half of the patients treated with CAR T therapy experience relapse. Part of that relapse is due to the loss of the target antigen, the CD19 antigen, that the CAR T cells are designed to attack. To address this, we’ve developed a triple CAR. If the patient’s cells lose that one antigen, the other two CARs remain available to target and kill the cells.

So, we are addressing a fundamental issue of relapse due to antigen loss in leukemia and lymphoma patients.

There are currently approved cures for sickle cell disease, but they cost $2.2 million and $3.1 million just for a single dose of cells. We can significantly reduce the cost of producing these therapies by at least tenfold, which is another critical area.

Thirdly, infectious diseases like HIV are important. HIV is currently controlled by drug therapy, but patients must remain on these drugs indefinitely to suppress the virus’s replication. Those of us in the field believe that if a cure is possible, it would be the best way to solve this issue, especially since long-term drug therapy has toxicities that accumulate over time. Many patients, particularly in Africa, are not on consistent therapy over long periods. In Western countries, patients are typically on therapy, but this is not the case in many other regions.

The entire field is working toward a single cure. Our CAR T-cell therapy is currently in clinical trials.

Jacobsen: How did collaborating with Fiocruz in Brazil help make gene therapies more accessible?

Dropulic: Yes. In that case, we actively collaborate with Fiocruz, sponsored by the Brazilian Ministry of Health. Caring Cross will transfer all the knowledge and technology needed to make the CAR T cells themselves and produce the vectors and some of the materials used to manufacture those CAR T cells. It’s a complete technology transfer, so Fiocruz can produce CAR T products locally more cost-effectively than purchasing them from the United States or other countries.

They achieve these efficiencies because they use local skilled labour, which is more cost-effective than labour in the United States. They can also produce the materials themselves. By producing both the products and materials locally, they gain significant efficiency.

Jacobsen: What about Vector BioMed to provide affordable GMP lentiviral vectors? How does that factor into reducing costs?

Dropulic: Yes, as I mentioned earlier, the cost of materials is a major issue, and vector cost is the single biggest material expense in producing these cells. When developing these inexpensive and robust workflows to produce CAR T cells, we couldn’t rely on third-party vector producers to provide them at a reasonable cost. Our teams have been making vectors for decades. Our team members were the first to put lentiviral vectors into humans and establish their safety.

Some of our team members also produced the vector that eventually became Kymriah. Novartis commercialized this first FDA-approved CAR T-cell product. With that extensive experience in vector production, we decided to create a public benefit corporation, Vector BioMed, to produce vectors at half the price for researchers or institutions that need them.

Any investigator needing a specific vector expressing a particular sequence can come to us for design and manufacturing. As a public benefit corporation, we also provide additional discounts for Caring Cross products to make them more affordable for our partners.

Jacobsen: I often mention this, especially after interviewing Gordon Guyatt, an epidemiologist in Canada and co-founder of Evidence-Based Medicine. He points out that values and preferences play a role in selecting healthcare systems in different societies. It’s not necessarily about technology, science, or medicine but about the values a country uses as a foundation for its healthcare system.

For example, Canada has a value and preference system focused on equity, which leads to a nationalized healthcare system with some degree of pharmacare. The United States, on the other hand, prioritizes autonomy, leading to a more privatized healthcare system.

Ignoring questions of efficiency and outcomes, if we look objectively at a society’s values and preferences, the following healthcare system reflects those values. So, do decentralized models for healthcare innovation help in nationalized or privatized contexts, especially considering the large differences in what’s valued in these systems?

Dropulic: It doesn’t make a huge difference, although a nationalized system may initially be easier to implement and deploy. It can help create a harmonious decentralized network, with payments by insurance and reimbursement being more standardized.

I see how this system works as well here in the United States, particularly in point-of-care manufacturing, especially when regional payers make things locally and efficiently. Government-related organizations like Medicare and Medicaid may find a localized hospital-based manufacturing network attractive. This approach can affordably produce these products consistently with high quality and at a sustainable price over the long term.

Jacobsen: How are the successes in India and Spain helpful for further implementation?

Dropulic: They are good examples showing that the system works, particularly in Spain, where it’s a fully reimbursable product. India is different, as it needs a true national health system. Implementation is based more on individual hospitals deploying and implementing these therapies locally. However, we’re seeing interest from companies and larger organizations in deploying point-of-care models and broadly deploying these technologies across India.

Jacobsen: Generally speaking, most societies have grown wealthier over the past 100 years, and the quality of life has also improved, whether in terms of education, health outcomes, or lifespan. While there may be individual or localized issues, the overall trend shows improvement in access to education and healthcare. With that general trend of improvement and the reduction in the cost of gene therapy, how long do you think it will be before even the poorest countries have access to these gene therapies at a reasonable cost relative to their national economic status, such as through purchase price parity (PPP)?

Dropulic: Some countries can move quickly. For example, Brazil has a sophisticated regulatory and biomanufacturing industry. In countries like Brazil, we can deploy technology quickly, supported by regulatory authorities connected to the FDA. Brazil’s regulatory framework allows them to learn and implement the knowledge within a proper regulatory structure.

Other countries, particularly in Africa, still need to develop a developed regulatory framework. Until that framework matures, it will take time for these technologies to be deployed. However, in terms of decreasing the price point for these therapies, we are moving quickly.

Each country or region will respond at its own pace, depending on its integration with the global gene therapy community, including regulatory bodies. Building the local infrastructure, training relevant clinical staff, and ensuring quality across a network of hospital sites will be critical to making these therapies affordable and sustainable.

Jacobsen: I have a personal question. How do you gain personal fulfillment as Executive Director, having worked in biotechnology for over 30 years?

Dropulic: I’m privileged to work in a space where we can help people suffering from serious diseases. We can provide potential cures by modifying cells to make them more functional, allowing them to kill tumour cells, eliminate infected cells, or replace defective genes. There’s nothing more rewarding than being in an area where the technology being developed and deployed in hospitals worldwide is actively helping people—giving them another chance at life. Many diseases we tackle are very serious, so being part of that journey is incredibly fulfilling.

Many of my team members feel the same way—we feel privileged to work in this space and have the opportunity to make a real impact. Whether it’s developing the workflows, producing the vectors, creating the actual medicines, or working with clinical investigators to bring these therapies through clinical trials to approval, the entire process is deeply meaningful because it ultimately benefits patients who need them.

Jacobsen: Thank you so much for the opportunity and your time today.

Dropulic: Thank you. I appreciate your time and interest.

Jacobsen: Excellent. Take care.

Dropulic: Bye-bye.

Caring Cross is a 501(c)(3) nonprofit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere.

To enable its mission, Caring Cross is developing technologies and therapeutic candidates to improve the accessibility, affordability, and applicability of advanced medicines like CAR-T therapy and stem cell gene therapy. Caring Cross founded Vector BioMed, a for- profit vector contract development and manufacturing organization (CDMO), specializing in rapid lentiviral vector manufacturing solutions, to provide the industry a source of affordable high-quality GMP Lentiviral vectors. For more information on Caring Cross visit https://caringcross.org. For more information on Vector BioMed visit https://vectorbiomed.com.

Partnering with Caring Cross

At Caring Cross, we are committed to advancing healthcare through innovative partnerships. With decades of experience in developing revolutionary therapeutic products, our team focuses on hematologic malignancies such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, and Multiple Myeloma, HIV and Sickle Cell Disease.

By partnering with like-minded inventors, hospitals, companies, and institutions, we can create additional innovation and value.

Our mission is to develop and implement improved technologies and therapeutic candidates that lower costs and improve access to novel CAR-T cell and other advanced therapies worldwide.

For more information on partnering with Caring Cross, visit https://caringcross.org/partnerships/

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