By Lilia Carolina Leon-Moreno, PhD
Postdoctoral Researcher
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México
On November 5th, 2024, the ISCT South & Central America (SCA) Regional Executive Committee and the SCA Regional ESP Subcommittee hosted an engaging webinar titled “Navigating CAR-T Cell Therapy Development: Insights from Leading SCA Academic Centers.” Co-chaired by Samuel Couto and Lilia León Moreno, the session brought together experts from Brazil, Mexico, and the United States to explore the challenges, innovations, and progress shaping CAR-T cell therapy in these regions. The event featured presentations from Virginia Picanço-Castro, Ph.D., Andrés Gomez-De León, M.D., and Chase McCann, Ph.D., MSPH, each offering unique insights into their respective areas of expertise.
Virginia Picanço-Castro, Ph.D.: Pioneering CAR-T in Brazil
Dr. Picanço-Castro opened the webinar with a comprehensive overview of the CAR-T cell therapy development journey at the Regional Blood Center of Ribeirão Preto in Brazil. She explored the complex pathway from academic research to clinical application, emphasizing the unique challenges and successes of her team in overcoming resource constraints.
Key takeaways from her presentation included:
- Challenges in Translating Academic Research to Clinical Products: Dr. Picanço-Castro highlighted the difficulties of transitioning from academic discoveries to clinically viable CAR-T products. These challenges require significant collaboration between researchers, clinicians, and regulatory bodies.
- Construction of a cGMP Facility: A milestone in her team’s efforts was establishing a current Good Manufacturing Practice (cGMP) cell therapy facility. This critical infrastructure enables the safe and standardized production of CAR-T therapies under stringent quality requirements.
- Manufacturing Challenges: She addressed specific manufacturing hurdles, particularly those concerning quality control processes for product release, which are crucial to ensuring the safety, potency, and consistency of CAR-T therapies. Additionally, she noted difficulties in accessing high-cost reagents and technologies within the local context.
- Future Opportunities to Develop Allogeneic CAR-T Therapies: Dr. Picanço-Castro emphasized Brazil’s potential to expand its expertise into allogeneic CAR-T therapies, which use donor-derived cells instead of autologous cells. These therapies offer the promise of reduced production times, lower costs, and broader accessibility, particularly in resource-limited settings. She highlighted the need for further research and investment to make this vision a reality.
- Bench-to-Bedside Innovation: Despite these challenges, Dr. Picanço-Castro’s team developed innovative, cost-effective protocols to bring CAR-T therapies closer to clinical reality.
Her presentation reinforced the importance of integrating academic expertise with robust infrastructure and forward-thinking strategies to advance biotechnology in Brazil and beyond.
Andrés Gomez-De León, M.D.: CAR-T Milestones in Mexico
Dr. Gomez-De León delivered an inspiring presentation on the development and future of CAR-T therapies in Mexico. Drawing from his leadership at Mexico’s largest transplant center, he provided an in-depth look at the local advancements shaping CAR-T research and clinical application.
Highlights of his talk included:
- First Vector Import for CAR-T: Dr. Gomez-De León’s team achieved a groundbreaking milestone by becoming the first group in Mexico to import the vector necessary for CAR-T cell therapy development. This significant achievement sets the stage for the country’s entry into CAR-T manufacturing.
- Clinical Trials Preparation: His institution is now actively preparing for clinical trials, marking a pivotal step toward delivering CAR-T therapies to Mexican patients. These trials will be instrumental in validating the safety and efficacy of locally developed CAR-T treatments.
- Regulatory and Resource Adaptation: Dr. Gomez-De León elaborated on the regulatory framework in Mexico, highlighting the need for streamlined processes to accelerate innovation. He also discussed cost-effective approaches tailored to the country's healthcare landscape, ensuring broader access to these groundbreaking therapies.
- Commitment to Equity: A champion for equitable healthcare, Dr. Gomez-De León stressed the importance of developing affordable CAR-T solutions to benefit patients in resource-limited settings.
This work positions Mexico as a leader in CAR-T therapy development within the region, demonstrating that innovation and accessibility can go hand in hand.
Chase McCann, Ph.D., MSPH: Advancing CAR-T Through Clinical Trials
Concluding the webinar, Dr. McCann shared his expertise on the role of clinical trials in CAR-T cell therapy development, with a focus on pediatric applications. Based on his work at Children's National Hospital in Washington, D.C., he provided valuable insights into the importance of research in refining and expanding CAR-T therapies.
Key points from his presentation included:
- Clinical Trials as a Catalyst: Dr. McCann emphasized the critical role clinical trials play in advancing CAR-T therapies, offering a pathway to optimize safety, efficacy, and accessibility.
- Pediatric Applications: He highlighted the transformative potential of CAR-T therapy for pediatric cancers, showcasing ongoing trials that are reshaping the treatment landscape for young patients.
- Real-World Insights: Drawing from his extensive experience, Dr. McCann shared practical lessons from trial implementation, including the importance of multidisciplinary collaboration to address challenges in CAR-T development.
Dr. McCann’s work underscores the necessity of combining rigorous research with patient-centered care to achieve breakthroughs in cell therapy.
A Collaborative Vision for CAR-T in SCA
The webinar highlighted the diverse approaches and shared challenges in CAR-T development across South and Central America and the U.S. Common themes included the importance of resource optimization, the role of local expertise, and the need for equitable healthcare access.
Key themes that emerged included:
- Innovation and Resourcefulness: Regional institutions are finding creative ways to navigate cost and infrastructure limitations, ensuring that CAR-T therapies are both effective and accessible.
- The Role of Clinical Trials: Ongoing trials are not only advancing the science of CAR-T but also building the evidence base needed to scale these therapies globally.
- Equity in Access: Ensuring that patients in resource-limited settings can benefit from CAR-T therapies is a shared priority, requiring collaboration across borders.
Looking Ahead
The ISCT SCA continues to foster dialogue and collaboration across the region, serving as a catalyst for advancements in cell therapy. This webinar showcased the strides being made in Brazil, Mexico, and the U.S., emphasizing the critical role of regional expertise and global partnerships in driving CAR-T therapy forward.
From Brazil’s innovative manufacturing strategies to Mexico’s milestone achievements in vector importation and trial preparation, and the U.S.’s cutting-edge clinical research, these efforts demonstrate a shared commitment to improving patient outcomes. Together, they pave the way for a brighter future in cell and gene therapy.
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