Expert Zahra Mahmoudjafari on Turning Innovation Into Implementation in Cell and Gene Therapy Programs

Cell and gene therapies (CGTs), including chimeric antigen receptor (CAR) T-cell therapies, tumor-infiltrating lymphocytes, and gene therapies, represent one of the most innovative and disruptive advances in modern medicine. They offer potentially curative, one-time treatments that fundamentally redefine how clinicians approach serious and previously incurable diseases.

In a recently published paper, Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, Pharmacy Practice in Focus: Oncology editor-in-chief and clinical pharmacy manager in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Health System in Kansas City, Kansas, and her coauthors describe a comprehensive, operational road map that health care institutions can use to successfully implement and sustain cell and gene therapy (CGT) programs.¹

Because these treatments are scientifically complex and resource-intensive, the authors propose a multidimensional framework that spans critical areas, including strategic planning, financial modeling, and clinical readiness. Successful delivery of CGT depends on a multidisciplinary approach that involves specialized roles in pharmacy, nursing, and administration to manage the unique toxicities of CGTs and the intricate supply chains.¹

What Does This Proposed Framework Include?

Successful implementation of CGT programs relies on a multidisciplinary steering committee that oversees resource allocation and aligns the program with institutional priorities, the authors explained. The following are the domains that Zahra and her coauthors propose for these program areas.

Strategy

Strategy serves as the foundational domain that aligns a CGT program with the institution or health system’s broader vision and secures the necessary infrastructure and investment for success. This idea involves multidisciplinary governance, such as a committee, that would include representatives from clinical services, pharmacy, nursing, operations, finance, and executive administration to oversee governance, resource allocation, and financial management while remaining aware of institutional priorities. A centralized leader (eg, program director or manager) with clinical and operational expertise will be needed to align resources, oversee timelines, and maintain accountability across all program domains.¹

Additionally, institutions must conduct structured assessments across multiple areas to ensure the program activation is safe, efficient, and sustainable. This would include mapping patient populations and determining staffing needs, as well as planning for risk mitigation and contingency planning to manage capacity constraints and operational disruptions.¹

Operations and IT

This domain focuses on the systems, workflows, and personnel needed to support the end-to-end patient journey safely and efficiently. A major component is facility qualification and onboarding. Achieving Qualified Treatment Center (QTC) status can take 6 to 18 months and requires meeting manufacturer criteria, completing staff training, and conducting mock runs to ensure proper product handling. Ongoing accreditation through organizations is also essential and often required by payers for reimbursement.¹

Operational readiness also depends on a strong clinical infrastructure and continuous coverage. Programs must ensure 24/7 provider availability and dedicated support from intensive care, neurology, and infectious disease services, among other specialties. Patients are ideally grouped on designated units staffed by nurses trained in cellular therapy protocols, toxicity grading, and escalation procedures.¹

Supply chain and product management are also critical, as these patient-specific therapies require rigorous chain-of-identity and chain-of-custody tracking from collection through administration. CGT coordinators oversee this time-sensitive process, managing logistics and maintaining communication with vendors and clinical teams, while institutions must maintain validated cryostorage systems with continuous temperature monitoring and backup power. Standardized workflows further underpin safe operations, with process mapping used to streamline the complex CGT pathway and comprehensive SOPs addressing patient selection, scheduling, product handling, and toxicity escalation. The framework also recommends a bimonthly “standard of care review” meeting to coordinate resources and workflows for routine CGT operations.¹

“What I see most often is that we have an overemphasis on the therapy and the clinical innovation of the therapy, which in and of itself is extremely exciting, and I don’t want to discredit that…but [there is] an underinvestment in the system around it. And so, some common readiness gaps that I see include…that fragmented ownership across departments,” Mahmoudjafari explained in an interview with Managed Healthcare Executive. “Often, we work in our own silos, and…we have immature workflows for referral and prior authorization, maybe underdeveloped financial modeling, so that fails to account for maybe looking at cash flow, timing, denied claims, or even patient attrition…. [CGT] programs don’t fail because the science doesn’t work—we’re definitely providing [proof] scientifically that they are working—but…because our infrastructure can’t absorb that complexity.”²

Access

Access is a multifaceted challenge that includes institutional access to products, patient access to specialized centers, and the reduction of socioeconomic and geographic barriers. Even after achieving QTC status, ensuring equitable patient access will require streamlined referral systems, such as a portal or a dedicated hotline staffed by a coordinator to ensure triage within 24 to 48 hours. Referral navigators play a critical role in coordinating logistics, insurance, and psychosocial support, while outreach to community oncology partners helps ensure appropriate and timely referrals for specialized CGT evaluation.¹

CGTs remain underutilized, particularly among patients from lower socioeconomic backgrounds or remote areas. Distance to treatment centers significantly affects therapy uptake—the authors cite data from one study estimating that reducing travel distance could increase CAR T-cell therapy use by approximately 38% and potentially save additional lives each year—but programs can promote equitable access by offering transportation, lodging, and financial counseling.¹

Finance

Financial barriers also require early payer engagement to clarify coverage and establish single-patient case agreements, alongside policy solutions such as the Centers for Medicare & Medicaid Services CGT Access Model, which applies outcome-based approaches to expand access while supporting sustainability. In addition, recent modifications by the FDA to Risk Evaluation and Mitigation Strategy (REMS) requirements—reducing the mandatory postinfusion monitoring period from 4 to 2 weeks—have reduced the travel and lodging burden for patients. Ultimately, Mahmoudjafari and her coauthors suggest sustained advocacy, policy reform, workforce development, and care models that extend these therapies beyond major academic centers into broader community settings.

“This space in particular requires partnership—partnership with our industry colleagues and also with our payer colleagues, and really looking to educate. Health systems are responsible for that education piece also, because our payers are looking to catch up with the innovation. And…the health systems that have been successful with this really work hard on defining coverage pathways, site of care expectations, and strategies for appeals before the first case,… looking to understand what each payer is wanting to establish up front,” Mahmoudjafari explained. “If you’re in the [US], you have to understand the government dynamics vs commercial differences with payer plans, and then [look] at aligning your coding and billing mechanic and modeling worst case scenarios, best case scenarios, and what…that looks like based on each payer.”³

Quality

In the proposed framework, it is essential to serve as a regulatory and safety bedrock, ensuring compliance with national standards and mitigating patient risk. Maintaining accreditation through the Foundation for the Accreditation of Cellular Therapy (FACT) or similar organizations is essential, as it establishes standards for cell collection, processing, and administration and is frequently used by payers as a criterion for reimbursement. Even when not explicitly required by manufacturers, FACT standards provide a widely accepted foundation for safe program expansion and quality assurance.¹

CGT programs must also maintain robust regulatory oversight, including dedicated data reporting teams to document training, adverse events, and product disposition for submission to the Center for International Blood and Marrow Transplant Research (CIBMTR). Compliance with FDA requirements and ongoing Institutional Review Board oversight for investigational therapies are mandatory, and centers are encouraged to leverage external resources, such as FACT consulting, CIBMTR, and the National Marrow Donor Program, to strengthen quality frameworks. A comprehensive quality management plan should include incident reporting, process audits, and performance metrics, supported by a strong culture of Continuous Quality Improvement (CQI). This culture relies on active audits, corrective and preventive action protocols, and regular multidisciplinary reviews, with quality team members integrated into operational readiness efforts to ensure standards are upheld and risks are mitigated during program activation. The quality infrastructure must also support ongoing process updates, including revisions to standard operating procedures and complex initiatives such as transitioning CAR T-cell therapy to the outpatient setting. High-quality outpatient care further requires well-designed processes and access to 24/7 support to ensure patient safety.¹

Outreach

Effective outreach begins with establishing collaborative relationships with community oncology practices and satellite centers through outreach visits, shared-care models, and comanagement agreements. Educational initiatives such as grand rounds, continuing medical education programs, and regional tumor boards help engage providers who treat eligible patients. Programs are encouraged to support longitudinal care coordination by offering early transition-back options so referring clinicians remain involved in long-term management, reinforcing partnership rather than transfer of ownership. Ongoing communication at key patient milestones and solicitation of provider feedback further strengthen referral pathways and workflow efficiency.¹

Outreach also encompasses marketing, visibility, and barrier reduction. Programs should build their presence within professional networks and patient advocacy communities, engage in media relations to increase public awareness, and share institutional outcomes, clinical trial opportunities, and success stories through newsletters and conference presentations. Maintaining a strong digital presence, including clear referral instructions and teleconsultation services, ensures accessibility for the broader medical community. Referral navigators are central to reducing barriers by coordinating transportation, lodging, and financial counseling, while proactive outreach connects referring providers with specialized centers for clinical trials as CGTs expand into new disease areas. Educating community partners to recognize late-onset symptoms after patients transition back to local care further supports continuity, ultimately bridging the gap between major academic centers and the broader community so that transformative therapies reach all eligible patients.¹

Pharmacy

As outlined in the paper, pharmacies and pharmacists are among the key interdependent domains imperative to the successful implementation of a CGT program, positioning pharmacists as pivotal figures in clinical, operational, and financial coordination.¹

Often, pharmacists take on central leadership roles in CGT programs, with experienced pharmacy managers often acting as program directors to align resources, manage timelines, and support governance through multidisciplinary steering committees. Clinically, pharmacists lead protocol development—including creating algorithms and standard operating procedures for patient selection and toxicity management—while overseeing medication management and ensuring access for essential supportive therapies. Pharmacists standardize processes that enable safe transitions to outpatient care.¹

Beyond clinical responsibilities, pharmacy teams manage key financial and regulatory functions, including budgeting, procurement decisions (such as buy-and-bill vs white bagging), 340B compliance, and revenue cycle support. As CGT evolves, pharmacists play an expanding role in biosafety and product integrity, developing handling protocols, maintaining the chain of identity through labeling and scanning processes, and ensuring appropriate specialized storage. They also lead education and training initiatives for multidisciplinary teams, patients, and caregivers, particularly in toxicity management, product handling, and protocol requirements.¹

“Pharmacy leaders should be involved early on and before a single patient is referred,” Mahmoudjafari said. “We should be involved in site selection decisions, contract reviews, if a product has a REMS program…. Too often, pharmacy is brought in once a therapy is approved and pharmacy is very well established…but due to the complexities, we are consistently being underestimated in our role here because we really function as operational integrators.”⁴

Conclusion

Realizing the full potential of CGTs requires more than scientific achievement; it demands a deliberate, parallel infrastructure development across multiple domains. Establishing synchronized workflows will ensure that all patients receive timely access to CGT when they need it most. Additionally, readiness in this treatment landscape must be multidimensional, encompassing strategic alignment, operational efficiency, robust data systems, and a culture of quality and accountability.¹

As the pipeline of novel agents expands rapidly, health systems that invest in coordinated, proactive processes will be best positioned to deliver safe, efficient, and sustainable care to patients. Building these capabilities in parallel transforms institutional readiness into true therapeutic readiness and ensures that the promise of these transformative therapies is fully realized for patients.¹

“There is no secret that with innovation has come some bumps in the road. The next 2 to 3 years will be [pivotal] because we’re seeing big impacts on volume expansion as more patients are able to receive these therapies,” Mahmoudjafari explained. “We’re migrating a lot of these therapies to the outpatient setting, but we’re also seeing some natural competition between these therapies as well. And so, what we’re also having seen on the cancer front, we have bispecific antibodies that may blur traditional lines.…”²

“The clinical trials have also pivoted to include more nononcology cancer disease states, which arguably [have] a lot more patients…. The paper highlights this; trying to write and design [clinical trials] for adaptability. I always used the [saying], ‘Write everything in pencil,’ because you’re going to have to backtrack and understand that this is a space that is moving quickly, but also kind of slowly in a lot of ways too, so centers do have time to prepare.”²

The full paper, “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs,” can be viewed here.

REFERENCES

1. Mahmoudjafari Z, McGuirk J, Ahmed N. From vision to viability: developing infrastructure for cell and gene therapy programs. Transplant Cell Ther. Published online January 7, 2026. doi:10.1016/j.jtct.2026.01.002

2. Contreras B, Mahmoudjafari Z. Strong systems are key to making cell and gene therapy programs work. Managed Healthcare Executive. Updated February 23, 2026. Accessed February 25, 2026. https://www.managedhealthcareexecutive.com/view/strong-systems-are-key-to-making-cell-and-gene-therapy-programs-work

3. Contreras B, Mahmoudjafari Z. Health systems are urged to partner with payers and plan ahead to make cell and gene therapy programs work. Managed Healthcare Executive. February 23, 2026. Accessed February 25, 2026. https://www.managedhealthcareexecutive.com/view/health-systems-are-urged-to-partner-with-payers-and-plan-ahead-to-make-cell-and-gene-therapy-programs-work

4. Contreras B, Mahmoudjafari Z. Pharmacy leadership is key to building safe and sustainable cell and gene therapy programs. Managed Healthcare Executive. Updated February 23, 2026. Accessed February 25, 2026. https://www.managedhealthcareexecutive.com/view/pharmacy-leadership-is-key-to-building-safe-and-sustainable-cell-and-gene-therapy-programs