Health Systems Face Growing Gap in Cell and Gene Therapy Implementation

New manuscript outlines practical strategies to address safety, operational and financial challenges.

As cell and gene therapies (CGTs) are increasingly incorporated into standard clinical care, health systems face a widening operational gap. An invited manuscript published in Transfusion outlines the challenge and presents a practical framework, informed by the experience at Nationwide Children’s, to guide integration into clinical practice.

CGTs differ significantly from traditional therapies. Many are patient-specific, require specialized handling, and must be administered within narrow timeframes. Despite these complexities, there is no standardized operational model across institutions. In many cases, responsibility is divided across pharmacy, laboratory and transfusion services, leading to variability in processes and potential safety issues.

“This lack of clear ownership introduces real risk at multiple points,” says Jill Blind, PharmD, MBA, pharmacy manager of the Translational Drug Service at Nationwide Children’s and senior author of the manuscript. “When therapies are handled outside the medication-use system, you lose built-in safeguards that clinicians rely on, such as standardized preparation, independent double-checks and clear documentation.”

To address this, the manuscript proposes a four-domain framework to support CGT integration into the medication-use process. The framework includes:

• Evaluation of pipeline therapies, including clinical, operational and financial readiness.
• Clinical integration through formulary review, electronic medical record configuration and standardized care pathways.
• Operational pharmacy integration, including infrastructure for storage, handling and dispensing.
• Financial integration, with strategies for reimbursement, budgeting and risk mitigation.

The work builds on newly released quality standards from the Association for the Advancement of Blood & Biotherapies (AABB), for which Dr. Blind served as one of only two health-system pharmacy representatives. While these standards define expectations for CGT pharmacy programs, they do not address implementation.

“The standards tell you what needs to be done, but not how to operationalize it,” Dr. Blind explains. “We wrote this framework to bridge that gap.”

The authors’ recommendations further emphasize early planning, multidisciplinary coordination, and alignment with the medication-use process to improve safety, consistency and efficiency as CGTs become more widely available.

The framework is grounded in institutional experience at Nationwide Children’s, where pharmacy has taken a leading role in integrating CGTs into clinical workflows. The hospital’s Translational Drug Service aligns investigational and commercial CGT therapies under a single operational structure, supporting a smooth transition from clinical trials to standard care.

Nationwide Children’s has also implemented pharmacist-led preparation for select time-sensitive therapies, including bedside preparation when required. This model enhances safety and allows nursing teams to remain focused on direct patient care.

“Our focus is on building systems that are both safe and scalable,” Dr. Blind says. “As these therapies continue to evolve, health systems will need a structured approach to keep pace.”

Nationwide Children’s is aligning its CGT pharmacy program with AABB standards in preparation for future accreditation, positioning pharmacy as a central driver of implementation.

“This is a pivotal moment,” Dr. Blind adds. “If we approach this proactively, pharmacy can help set the standard for how these therapies are delivered — bringing consistency, improving safety and making sure patients receive the full benefit of these new advances in clinical care.”

Reference:

Pennock D, Wheaton K, Shay B, Blind J. From innovation to implementation: Health-system pharmacy integration of cell and gene therapies. Transfusion. 2026. https://doi.org/10.1111/trf.70110.

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