Cell therapies, particularly CAR T-cell therapy, have revolutionized the treatment landscape for various cancers. These therapies involve modifying a patient’s own cells to better target and eliminate cancer cells. However, as participants at the symposium noted, the complexity of these treatments often leads to significant hurdles in terms of delivery and accessibility for patients in need.

Anna Van Muyden, Head of Clinical Science Oncology at Galapagos, emphasized the need for collaboration between industry and clinical centers. “Delivering cell therapies to patients and ensuring patient access is a complex endeavor,” she noted. By establishing decentralized CAR T manufacturing models, Galapagos aims to provide fresh CAR T cells within a week, thereby reducing wait times and overcoming logistical challenges associated with centralized manufacturing facilities.

Despite the advancements in therapy, access remains an issue. Stephen Ward, Chief Technology Officer of the Cell and Gene Therapy Catapult, pointed out that while the UK has developed clinical networks to facilitate access, similar infrastructure is lacking in other regions, including the U.S. This discrepancy often leads to inequities in who can receive these life-saving treatments.

Dr. Marcos J. de Lima, Director of Stem Cell Transplant and Cellular Therapy at Ohio State University, echoed these sentiments, discussing the challenges of patient recruitment. Referral networks are often underdeveloped, and disparities in demographics can lead to unequal access to therapies. He highlighted that even when therapies are available, many patients remain unaware of clinical trials or alternative treatment options, underscoring the need for better education and outreach.

To help bridge this gap, the National Cancer Institute (NCI) provides a searchable database of clinical trials that can connect patients with potentially life-saving treatment options.

One of the most significant innovations in the CGT field is the shift toward decentralized manufacturing models. This approach aims to shorten the time patients wait for treatment. This model not only expedites the delivery of therapies but also addresses the logistical challenges associated with traditional centralized manufacturing, which can lead to extended waiting periods and increased costs.

As Stephen Ward explained, the advancement of decentralized manufacturing is crucial. “We need to think about how we can leverage technology to streamline the process and improve patient outcomes,” he stated. By decentralizing production, therapies can be delivered closer to where patients are, potentially improving access for underserved populations.

Carol Houts, Chief Commercial and Strategy Officer at Germfree, also added that discussions on centralized versus decentralized manufacturing during the event have reinforced the need for flexible solutions that balance efficiency with patient access. The evolving accreditation landscape, workforce training needs, and operational challenges must be addressed to help clinical sites scale cell therapy programs effectively. Germfree’s mobile and modular cleanroom solutions are part of this effort, enabling clinical centers to improve operational efficiency and better serve patients in need.

Cost is another critical factor that cannot be overlooked. The financial burden associated with CGT includes not only the therapy itself but also hospitalization and management of potential adverse events. Anna Van Muyden of Galapagos noted that “if we can develop safer CAR T products, we could treat patients in outpatient settings, further broadening access.”

This sentiment echoes the broader call for innovation in cell and gene therapy—both in terms of product safety and financial viability. Phyllis Warkentin, Chief Medical Officer of UNMC, pointed out that “cell therapy is more than just the product; it’s about the entire continuum of care.” This comprehensive approach includes everything from product collection and transportation to long-term follow-up care.

One of the most thought-provoking discussions at the symposium came from Alexander Seyf, CEO of Autolomous, who highlighted the critical role of digital innovation in CGT manufacturing. He emphasized that automation and digitization are key to overcoming bottlenecks in cell therapy production. “We’re still relying on many manual processes in cell therapy manufacturing,” Seyf pointed out. “By implementing digital solutions, we can enhance traceability, reduce errors, and accelerate batch release times, ultimately improving patient outcomes.” Autolomous is pioneering AI-driven platforms that optimize workflows in CGT production, ensuring real-time tracking of patient cells from collection to infusion. This level of transparency and efficiency, he argued, is essential for achieving true scalability in decentralized manufacturing.

Furthermore, Seyf noted that integrating digital systems with regulatory frameworks can streamline compliance, making it easier for companies to meet stringent quality and safety standards. “If we want to democratize access to cell and gene therapies, we need to remove inefficiencies in the system,” he concluded.

John Lee, Global Head of Cell & Gene Therapy at SK Pharmteco, and Jon Ellis, CEO of Trenchant BioSystems, added that the industry needs to turn advanced therapy manufacturing into a “go-do” process, reducing the variability that currently makes it a complex and heterogeneous challenge. By sharing data across the industry, companies—especially startups—can focus on the unique aspects of their processes rather than reinventing common manufacturing practices. This collaboration removes unnecessary burdens and allows therapies to reach patients more quickly without compromising intellectual property. Standardizing these efficiencies is a key step toward making advanced therapies more accessible.

As the symposium progressed, it became clear that collaboration across various stakeholders is essential for overcoming the challenges associated with CGT. The concept of “hub and spoke” models was discussed, where academic centers can serve as hubs of expertise, guiding community hospitals in delivering complex therapies. “We need to empower community centers while maintaining the safety and efficacy of treatments,” stated Warkington.

Education was another recurring theme. John Ellis, CEO of Trenchant Bio, underscored the need for standardization in manufacturing processes, while also emphasizing the importance of educating healthcare providers. “Many physicians are not aware of the full spectrum of clinical trials available, which limits patient access to cutting-edge therapies,” he noted.

Patient advocacy is also vital in raising awareness about available therapies. Brad Watts, a former CAR T patient and advocate, emphasized the importance of sharing personal stories to inform others about their treatment options. Organizations like the Emily Whitehead Foundation provide crucial support and awareness initiatives to help families navigate treatment options. By connecting patients with resources and education, the industry can help individuals make informed decisions about their care.

The conversation at Advanced Therapies Week 2025 painted a hopeful picture of the future of cell and gene therapy. The collective insights from the experts underscored the potential for decentralized manufacturing, improved patient access, and enhanced collaboration to create a more equitable healthcare landscape.

As we move forward, it is crucial to leverage the lessons learned from ongoing initiatives and to continue advocating for patients. The symposium concluded with a call to action: a commitment from all stakeholders to work together to ensure that the promise of CGT becomes a reality for every patient in need.

In the words of Anna Van Muyden, “We have an obligation to come together and move the needle on patient access.” The future of cell and gene therapy depends on our collective efforts to ensure that these groundbreaking treatments reach those who need them most.

For further reading, visit:

• FDA Cell & Gene Therapy Resources: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
• ClinicalTrials.gov: https://clinicaltrials.gov/
• ISCT Standards and Guidelines: https://www.isctglobal.org/page/standards-for-cgt-manufacturing