Five Steps for Successful CGT Commercialization Through Health Systems Partnerships

Effective engagement with health systems is an important yet underemphasized step for cell and gene therapy (CGT) manufacturers transitioning from clinical development to commercial launch. The commercial landscape introduces unique operational, financial, and patient access challenges that differ significantly from a clinical trial setting, and health systems play a pivotal role in patient access and therapy adoption.

This topic is especially timely, with industry leaders having recently gathered at events such as Meeting on the Mesa, Association for Value-Based Cancer Care (AVBCC) 2025, and Cencora’s annual Health Systems customer summit to discuss the future of CGT commercialization and health system collaboration.

Health systemswith priorexperience in CGT clinical research are not immune to the challenges encounteredwhen standing up a commercial program. CGT manufacturers must be ready to proactively address these challenges with early and frequent collaboration with health systems leads to help streamline workflows, minimize disruptions, and enhance patient access.

To explore how CGT manufacturers can support commercial adoption and better support health systems, Cencora gathered insights from three pharmacy leaders from different health systems: a chief pharmacy officer, a pharmacy director, and a pharmacy manager—identifying key areas for collaboration and tailored engagement to address the challenges of integrating CGTs into routine care.

Navigating the transition from clinical research to commercialization

Transitioning CGTs from clinical trials to administration under a commercial program requires critical adjustments in delivery, as processes that work in research settings often fail to translate directly to the operational complexities of hospital environments. This necessitates close collaboration between CGT manufacturers and health systems to help adapt clinical protocols for scalable, commercial realities.

Adapting to a commercial setting

Replicating clinical trial protocols in a commercial setting is not practical, and unlikely to be effective. For instance, one health system encountered challenges when a CGT protocol used an operational process based on QR codes scattered throughout the hospital.

The method was suitable for a small-scale and high-touch research protocol, but not scalable for a commercial program. Health systems can provide critical feedback through feasibility assessments conducted during the trial phase, which offer CGT manufacturers early insights into operational needs and highlight process adjustments necessary for commercialization.

Understanding medication-use process

With high upfront costs, operational complexity, and unique safety monitoring considerations, health systems must understand every step of the medication-use process of CGTs before they can safely and confidently administer them. Early, detailed collaboration gives health systems the information needed to deliver CGTs safely and effectively in a commercial setting.

CGT manufacturers should be ready to guide health systems through each stage. From procurement and prescribing to administration, monitoring and evaluation, it is necessary to ensure that infrastructure, staffing, and reimbursement strategies are aligned up front to help ease the transition from clinical study to real-world care.

Conducting site visits to prepare for commercialization

Pre-commercialization site visits are invaluable for manufacturers to observe hospital workflows, identify potential barriers, and gather operational insights and key details, such as cell lab layouts, available equipment, delivery logistics, required signatures, and internal transportation and storage.

Strategic partners with established health system relationships can facilitate access and guide these engagements. Further, even a single site visit early in the commercialization process can uncover critical details that shape launch readiness and streamline protocols, and create efficiencies for the commercial environment.

Addressing challenges that health systems face in offering CGTs

The challenges health systems face in offering CGTs may fall into three key categories:

• Aligning payment timing. After a therapy’s approval and commercial launch, high upfront costs and delayed payer reimbursements can limit a health systems’ ability to treat every patient seeking care, as they may struggle to carry the financial burden in the interim. This may be especially challenging under buy-and-bill models. To mitigate this, manufacturers should continue to engage with health systems to help address this challenge that may impact their ability to continue to offer the therapy, structuring payment terms that better align with reimbursement cycles to reduce budget strain. Establishing this type of financial alignment early builds trust and removes a major obstacle to scaling access.
• If commercial products do not meet release specifications after manufacturing. When CGTs fail to meet release specifications after manufacturing, patient care and safety is the top concern, but operational fallout for treatment centers is also significant. Delays, cancellations, and uncertainty around communication can erode trust and disrupt care. Health systems want clear protocols and shared accountability, so CGT manufacturers should proactively address risks during onboarding by working with these sites of care to define how and when they will be notified of issues, clarify informed consent language around manufacturing failure scenarios, and establish escalation plans for patient communication and care transition. Such early, transparent collaboration gives both parties the ability to respond strategically and maintain patient focus in high-stakes situations.
• Delayed contracting with manufacturers. Becoming an authorized CGT treatment center can take months or even years due to complex contracting processes. To reduce time to launch, some health systems have adopted a dual-track approach that allows different parts of the process to advance simultaneously, and which centralizes certain agreements at the health system level. These typically include master service agreements, terms and conditions, and data security protocols, which can be standardized and executed across all affiliated sites. At the same time, local site-level agreements move forward independently. These include quality and trade agreements, informed consent documentation, and operational workflows specific to each treatment location. By separating centralized and local responsibilities, health systems can reduce bottlenecks and accelerate the overall authorization process. Manufacturers that recognize and align with this model are better positioned to avoid delays and become more effective partners in launching CGTs at scale.

Closing thoughts

Health systems are deeply committed to guiding patients through their entire care journey, and introducing novel therapies, such as CGTs, is just one part of that larger responsibility. CGT programs are nuanced and require seamless alignment of multiple stakeholders.

An early investment into understanding your program holistically, from the ground up, can help position CGT manufacturers for launch as well as lay the framework for effective troubleshooting if necessary. Real-world constraints, such as shifting priorities, patient complications, or operational hurdles, can require pauses or adjustments to treatment plans.

During these moments, CGT manufacturers must approach their partnerships with patience and flexibility.

Clinical trial protocols often don't translate directly into hospital treatment settings. What works in a tightly controlled research environment may be impractical or unsustainable in day-to-day care.

Manufacturers should collaborate with health systems to map and refine each step of the medication-use process to help enable realistic therapy integration into existing workflows. As the CGT landscape evolves, so must the relationship between manufacturers and health systems.

Both face shared challenges, including financial constraints, staffing shortages, and resource limitations. These must be addressed together as the number of CGTs entering the market grows.

For manufacturers and health systems alike, proactive partnership consisting of early engagement, mutual understanding, and operational alignment is not only the key to long-term success, but also to unlock the full potential of CGTs, allowing patients to benefit from the next wave of medical innovation.

About the Authors

Kevin Chinn, VP, Head of Cell & Gene Service Line, Cencora.

Louis Cicchini, PhD, Senior Director of Scientific Affairs for Cell & Gene Therapy, Cencora.