Article

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

As cell and gene therapy (CGT) manufacturers transition from clinical development to commercial launch, engaging with health systems becomes essential. The commercial landscape presents operational and financial challenges that differ significantly from the clinical trial setting. Health systems play a pivotal role in patient access.

Even if a health system has prior experience with a CGT in a research context, commercializing that same therapy often requires overcoming new barriers. CGT manufacturers that understand and address these challenges can help improve the process for their therapies being successfully integrated into routine care for appropriate patients. Early collaboration between CGT manufacturers and health systems can lead to more efficient workflows, fewer disruptions, and potentially improve patient access to therapies.

To better understand how CGT manufacturers can support improved patient access to CGTs within health systems, Cencora gathered insights from three pharmacy leaders from different health systems: a chief pharmacy officer, a pharmacy director, and a pharmacy manager. The following insights focused on two areas: transitioning a health system from participating in CGT clinical research to its commercialization; and addressing the challenges health systems face in offering CGTs after being fully commercialized. 

Transitioning from clinical research to 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.

Adapting to a commercial setting

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. 

Understanding the medication-use process

CGTs can have high upfront costs, operational complexity, and safety monitoring considerations. This is why health systems must understand every step of the medication-use process before they can confidently make these therapies accessible to patients. Early, detailed collaboration with CGT manufacturers gives health systems the information they need to inform the medication-use process in order to safely and effectively deliver and administer CGTs after a therapy has been approved.

CGT manufacturers should be ready to help provide relevant information to health systems through each stage, from procurement to administration, monitoring, and evaluation. Health systems need to ensure that their infrastructure, staffing, and reimbursement systems are aligned. Addressing these considerations upfront helps smooth the transition from clinical trial to real-world care.

Medication-use process
The medication-use process is a structured framework used by health systems to ensure the safe, effective, and coordinated delivery of medications to patients. It's a multistep process that documents how the drug travels from the pharmacy to the patient.

The process requires the coordination of various health system departments and professionals.1 When a health system performs all the steps of a medication-use process for a therapy, it utilizes the fundamentals of safety and risk management to optimize patient outcomes. 

Key questions for understanding the medication-use process 
Health systems may need answers to the following questions to help them understand the medication-use process for a newly commercialized therapy. 

  • Procurement
    - What logistics are involved if becoming an authorized treatment center is required?
    - Are there accreditation requirements our health system must meet?
    - Will we work through a wholesaler or purchase directly?
    - Are there proprietary web-based portals that we would need to use? If so, what security processes need to be completed in order to access the portal as quickly as possible? 

  • Prescription
    - What is the entire patient journey from end to end?
    - Is the therapy administered via an inpatient or outpatient setting? Or both?
    - If it’s a combination of inpatient and outpatient, how does that affect the patient journey? Does it affect the process for billing and reimbursement?

  • Access
    - Are outcome-based models an option?
    - Do you have a patient support program for patient access?
    - Do you provide co-pay support for eligible patients? If so, how?
    - What has billing and coding looked like for other hospitals? 

  • Dispensing
    - What are the storage and delivery requirements for the therapy?
    - If the therapy is considered hazardous, will I be able to use it with a closed-system transfer device?

  • Administration
    - How is the therapy administered?
    - Does it need special equipment or devices for preparation and administration? 

  • Monitoring and evaluation
    - How do we educate our team on what to look for and when in post-treatment?
    - Does the product label provide information related to management of adverse events (AE)?
    - How should patient results be documented and reported in a compliant manner?

Conducting site visits to prepare for commercialization

CGT manufacturers can collect important information before commercialization by coordinating with health systems for potential site visits if allowed by the institution. These interactions could help manufacturers better understand hospital workflows and provide the opportunity to identify potential barriers before launch.

For example, interactions with the health system may help CGT manufacturers better understand critical hospital details that impact access to their therapy, such as:

- What are the hospital’s cell lab capabilities
- What common equipment is available
- How special deliveries are made
- How transportation and storage within the hospital work

Although emerging CGT manufacturers may find site visits resource-intensive, third-party partners with established health system relationships may be able to help facilitate access and guide appropriate engagements. Even a single site visit early in the commercialization process can uncover critical details that shape launch readiness.

By better understanding health system resources and operations, a manufacturer can help streamline their approach to commercialization. 

Addressing the challenges health systems face in offering CGTs

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.

Aligning payment timing with health system realities

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.

Addressing when commercial products do not meet release specifications after manufacturing 

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.

Accelerating the treatment center authorization process 

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.

Closing thoughts

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.

REFERENCES:

  1. Vogenberg, F. et al. The Medication-Use Process and the Importance of Mastering Fundamentals. Pharmacy & Therapeutics. October 2011. Accessed on 22 July 2025. Available online at: https://pmc.ncbi.nlm.nih.gov/articles/PMC3278147/


DISCLAIMER: This article may contain marketing statements and shall not constitute legal advice. Cencora, Inc. strongly encourages readers to review this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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