Advanced Therapies Week 2025: New Market Models for Supply

The video features an in-depth panel discussion and expert insights centered on supply chain risk mitigation and accreditation in the advanced cell and gene therapy field, particularly focusing on CAR T and immune effector cell therapies. George Eastwood from the Emily Whitehead Foundation opens the discussion emphasizing the critical patient connection in cell therapy supply chains and the unique challenges posed by these personalized therapies. Bill Beck, a seasoned supply chain director with extensive experience spanning 18 years in cell therapy manufacturing and startups, shares practical lessons on managing agile supply chains, risk mitigation, and the complexities of handling patient-derived starting materials.

A key theme throughout the discussion is the necessity of agility and integrated business planning in the supply chain to handle uncertainties in demand and supply, especially as these therapies scale. Bill highlights how timelines in advanced therapy manufacturing are often compressed, yet risk mitigation efforts require long-term planning due to the complexity and duration of capacity ramp-up and process development.

The conversation then shifts to FACT (Foundation for the Accreditation of Cellular Therapy), represented by Phyllis, which plays a pivotal role in setting peer-driven standards and accreditation processes to ensure quality and patient safety in cell therapy programs. FACT’s evolving modular accreditation model allows for flexible and scalable accreditation of diverse clinical programs, collection centers, and manufacturing facilities, including standalone immune effector cell therapy programs. The introduction of a “hub and spoke” accreditation model for apheresis centers and the innovative FACT Readiness Assessment, designed to remove barriers to patient access by accrediting programs before they treat five patients, demonstrates FACT’s commitment to expanding therapy availability while maintaining quality.

Sam Keith of Blood Centers of America (BCA) elaborates on how BCA’s extensive national network supports advanced therapies with a robust supply chain infrastructure. BCA’s risk mitigation strategies, such as diversified supplier relationships, consigned inventory with third-party logistics partners, and a geographically distributed apheresis and cryopreservation network, help ensure reliable material availability. Sam underscores the lessons learned from the COVID-19 pandemic about the critical importance of supply chain resilience and collaborative partnerships with suppliers.

Throughout the panel, a strong emphasis is placed on collaboration across the ecosystem—including manufacturers, clinical sites, suppliers, accrediting bodies, and payers—to overcome challenges related to patient access, capacity constraints, and regulatory complexities. The discussion highlights the need for standardized approaches, shared responsibilities, and innovative logistical models to improve scalability and patient outcomes in this rapidly evolving sector.

Highlights

• Importance of agility and integrated business planning in cell therapy supply chains.
• Patient-derived starting materials require unique supply chain handling and risk mitigation.
• FACT’s modular accreditation model enhances flexibility and scale in cell therapy programs.
• Introduction of a “hub and spoke” model for apheresis center accreditation to expand capacity.
• FACT Readiness Assessment aims to reduce barriers and increase patient access.
• BCA’s national network supports advanced therapies with risk-mitigated supply chain strategies.
• Collaboration among manufacturers, suppliers, clinical sites, and accrediting bodies is critical for scaling advanced therapies.

Key Insights

• Agility in New Market Models: Bill Beck stresses that traditional supply chain models are ill-suited for advanced therapies, which require agile planning and supplier partnerships comfortable with rapid changes. This agility is crucial given the unpredictable demand and the personalized nature of cell therapies. Integrated business planning must align with this need to ensure supply chain responsiveness and avoid detrimental mismatches.
• Long-Term Risk Mitigation Planning: Risk mitigation in cell and gene therapy is a long-term strategic activity, not just a quick fix for immediate issues. Building capacity, developing capabilities, and implementing new processes often take longer than expected, while commercial and clinical pressures push for accelerated timelines. Organizations must plan risk mitigation well ahead to avoid being caught unprepared.
• Patient Material as Critical Raw Material: The starting material in cell therapy is a patient’s own or donor’s cells, making it fundamentally different from traditional raw materials. This introduces variability and complexity in manufacturing planning, requiring strict controls, coordination with clinical teams, and contingency plans for manufacturing failures or cancellations to ensure patient treatment continuity.
• FACT’s Modular Accreditation Enhances Flexibility: FACT’s move toward modular accreditation allows entities to be accredited for specific components—clinical programs, collection centers, or processing facilities—individually or in combination. This flexibility supports diverse operational models, including standalone immune effector cell therapy programs, and facilitates collaboration via contracted services, thus broadening access and improving quality assurance across the ecosystem.
• Hub and Spoke Model for Apheresis Centers: FACT’s innovative hub and spoke accreditation model enables a central accredited entity to oversee multiple distant collection sites, ensuring consistent quality management and personnel competency. This model could significantly increase collection capacity, reduce redundancies, and better address geographic patient needs by enabling networked coordination of collection resources.
• FACT Readiness Assessment to Overcome the “Five Patient” Barrier: The traditional requirement for programs to treat five patients before accreditation has been a barrier to new program initiation and patient access. The Readiness Assessment allows programs to be accredited based on readiness (excluding patient volume), enabling them to start treating patients and obtain reimbursement sooner while working toward full accreditation. This initiative is a crucial step toward expanding therapy availability.
• BCA’s Supply Chain Resilience and Collaboration: BCA’s extensive network of blood centers, apheresis machines, ISO 7 clean rooms, and cryopreservation sites, paired with strategic supplier contracts and consigned inventory managed through third-party logistics, exemplifies a resilient, scalable supply chain infrastructure. Their approach to supplier diversification, contract portfolio expansion, and collaboration with manufacturers ensures operational continuity and cost management, especially critical in light of pandemic-induced disruptions.
• Ecosystem Collaboration as a Success Factor: The panel repeatedly underscores that no single entity can solve the complex challenges of cell therapy supply chains alone. Collaboration between manufacturers, clinical sites, suppliers, accrediting bodies, and payers is necessary to align incentives, streamline audits, optimize capacity utilization, and ensure regulatory compliance. This cooperative approach is essential to breaking down barriers to patient access and scaling these innovative therapies effectively.
• Balancing Centralization and Decentralization: The discussion reveals that the future will likely involve a hybrid approach with both centralized and decentralized models for therapy delivery and manufacturing. Automation, standardization, and innovative logistics solutions are needed to reduce costs and meet diverse patient needs across geographies. The ecosystem must remain adaptable to incorporate various modalities and evolving regulatory and payer landscapes.
• Addressing Patient Access Gaps: Despite rapid innovation, approximately 80% of eligible patients currently do not receive advanced cell therapies. The supply chain and accreditation innovations discussed, such as modular accreditation, readiness assessments, and hub-and-spoke models, are designed to address this gap by enabling more centers to participate safely and efficiently in therapy delivery.
• Regulatory and Payer Education is Critical: The panel notes that regulatory bodies and payers are still catching up with the nuances of cell and gene therapies, especially allogeneic donor qualification and manufacturing processes. Continued education and collaboration with these stakeholders are essential to developing appropriate frameworks that support innovation while ensuring patient safety.
• Data-Driven Quality Management: The hub and spoke model envisions comprehensive quality management plans that collect and analyze data across multiple collection and clinical sites. Comparing adverse events, productivity, and risk across these sites can drive performance improvements and ensure consistent patient safety standards, leveraging economies of scale while managing operational variability.
• Reducing Audit Redundancy: Multiple audits by different manufacturers and payers create inefficiencies, especially for busy infusion sites. Standardized accreditation and collaborative audit sharing can reduce redundancy, allowing clinical sites to focus on patient care and enrollment rather than repetitive compliance activities.
• Lifecycle Strategy and Technology Integration: Manufacturers and supply chain leaders must balance fast-to-market strategies with the need to incorporate innovations such as automation and improved analytical comparability over time. Strategic lifecycle planning ensures that technology upgrades do not disrupt supply continuity and patient access while driving cost efficiencies and quality improvements.

Speakers:

• George Eastwood – Executive Director, Emily Whitehead Foundation
• William Beck – Director, Supply Chain, BlueRock Therapeutics
• Phyllis Warkertin – Medical Director, Foundation for the Accreditation of Cellular Therapies (FACT)
• Sam Keith – SVP of Supply Chain & Business Development, Blood Centers of America (BCA)

Conclusion
The panel discussion provides a comprehensive overview of the current challenges and innovations in supply chain and accreditation practices within the advanced therapy field. By emphasizing agility, collaboration, modular accreditation, and strategic risk mitigation, stakeholders are working collectively to scale these life-saving therapies while maintaining quality and expanding patient access. The evolving models introduced by FACT and supported by organizations like BCA exemplify how infrastructure, standards, and partnerships must evolve in tandem with scientific advances to realize the full potential of cell and gene therapies.