Tips for partnering with health systems: A critical step for CGT commercialization

When health systems move from participating in CGT clinical trials to the commercial use of the same therapies when approved, a fundamental shift is required. Processes that worked in research settings often don’t translate directly to the complexities of day-to-day hospital operations. To help ensure a smooth transition, CGT manufacturers must work closely with health systems to adapt to commercial realities.

When health systems have to replicate the same processes used in clinical trials in a commercial setting, it is rarely effective. For instance, one health system encountered challenges when a CGT manufacturer used the same delivery process utilized in their clinical trials for the commercial setting once the therapy was approved.  The method was suitable for research but was not scalable for a commercial program. 

Hospitals’ standard operating environments require streamlined, scalable solutions. The clinical trial phase offers an opportunity for health systems to provide critical feedback to CGT manufacturers. Through conducting their own internal feasibility assessments regarding processes, healthy systems can offer CGT manufacturers early insights into potential operational needs if a therapy is commercialized – for delivery, storage, preparation, and administration – and highlight process adjustments that might make it easier for hospitals to provide these treatments once they are commercialized. 

When a therapy becomes commercialized, CGT manufacturers should continue to engage with health systems to help address challenges that may impact a health system’s ability to provide access to the therapy.

The high upfront costs of CGTs could potentially impact a health system's goal of ensuring access for all appropriate patients. 

If a health system does not receive reimbursement or reimbursement is significantly delayed, it may bear a significant financial risk from the high upfront cost of the therapy. Manufacturers and wholesalers can help mitigate this risk. By partnering with the health system to coordinate the payment schedules for health systems, manufacturers and wholesalers can help lessen the impact on health system cash flow and help maintain patient access.

When a CGT fails to meet release specifications – part of the CGT’s critical quality attributes (CQAs) they need to meet after manufacturing – patient safety is always the top concern. However, the operational impact for treatment centers is also significant. Delays, cancellations, and uncertainty around communication can erode trust and potentially disrupt care.

Health systems want clear protocols and collaboration. CGT manufacturers can work to proactively address these risks during onboarding by working with health systems to:

- Define how and when treatment centers will be notified of issues
- Establish escalation plans for necessary communications to patients

Early, transparent communication gives both parties the ability to respond strategically and maintain patient focus in high-stakes situations.

Becoming an authorized CGT treatment center can take months or even years due to complex contracting processes. To reduce the time it takes to become authorized, some health systems have adopted a dual-track approach that allows different parts of the process to advance simultaneously.

Under this model, certain agreements are centralized at the health system level. These typically include master services agreements and data security protocols, which could 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, and operational workflows specific to each treatment location.

By separating centralized and local responsibilities, health systems can reduce bottlenecks and accelerate the overall process. Manufacturers that recognize and align with this model are better positioned to avoid delays and become more effective partners in helping to enable access for CGTs at scale.

The pharmacy leaders agreed that collaboration with CGT manufacturers is needed and believe this engagement may help to improve some of the operational, clinical, and financial challenges that health systems may face when offering CGTs. Health systems are deeply committed to guiding patients through their entire care journey, and introducing a new therapy is only one part of that larger responsibility. While CGTs offer promise for some patients in need, real-world constraints, such as shifting priorities, patient coordination complications, or operational hurdles, can potentially impact care. In these moments, CGT manufacturers must approach partnerships with patience and flexibility.

The pharmacy leaders also made clear that it is essential to recognize when processes that were used in clinical trials don't translate directly into the hospital setting. What works in a research environment may be impractical or unsustainable in day-to-day care. Manufacturers should take a collaborative approach, engaging with health systems as appropriate to help achieve the shared goal of achieving patient access to CGTs. The pharmacy leaders underscored how, as the CGT landscape continues to evolve, so too must the relationship between manufacturers and health systems. Both may face similar challenges, including financial constraints, staffing shortages, and resource limitations that must be addressed to prepare for the influx of new therapies on the horizon. Long-term success will depend on early engagement, mutual understanding, and operational alignment.