Meet the Author: Dr. Zahra Mahmoudjafari — ‘From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs’

Dr. Zahra Mahmoudjafari, PharmD, BCOP, FHOPA, MBA, is the first author of the article “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs.” She shares in this Q&A background on how this research came about, findings that particularly surprised her, and how these findings are guiding current and future initiatives. Read on for this perspective, and then visit Transplantation and Cellular Therapy, the official journal of ASTCT, for the full article.

Nucleus: What question or concern initially prompted your team to investigate cell and gene therapy (CGT) program structures?

Dr. Zahra Mahmoudjafari (ZM): Our team recognized that successful CGT delivery requires far more than physician expertise or product availability, it demands coordinated infrastructure across clinical operations, pharmacy, quality, finance, informatics, and leadership.

We wanted to explore what differentiates programs that are truly sustainable from those that struggle with fragmentation, inefficiency, or safety concerns. The article was ultimately driven by a need to translate the promise of CGTs into practical, scalable systems that support both patients and health systems and demonstrate to other systems the infrastructure required to make it possible.

Nucleus: What are the critical infrastructure domains every institution must have in place to deliver cell and gene therapies safely and sustainably, and where do most programs fall short?

ZM: Successful CGT programs require integration across several foundational domains, including governance, pharmacy operations, cellular logistics, toxicity management pathways, financial coordination, data infrastructure, quality oversight, and multidisciplinary communication.

Many institutions initially underestimate the complexity of operational workflows that occur outside the infusion itself, particularly around coordination, real-time decision making, and longitudinal patient monitoring. Programs commonly fall short when infrastructure develops reactively instead of proactively, leading to siloed communication, inconsistent escalation pathways, and strain on staff resources.

Sustainable programs are those that intentionally build systems designed for scalability, standardization, and continuous adaptation.

Nucleus: How can health systems translate the promise of CGTs into real world practice without compromising patient safety, regulatory compliance, or financial sustainability?

ZM: Health systems must approach CGTs as enterprise-level programs rather than isolated therapeutic offerings. This requires early investment in standardized workflows, multidisciplinary governance structures, and operational accountability across departments.

Institutions that are most successful tend to embed quality and safety into the program design from the beginning, while simultaneously developing financial models that account for reimbursement variability, staffing demands, and evolving site-of-care expectations. Importantly, scalability cannot come at the expense of patient-centered care, particularly as therapies move earlier in treatment paradigms and into outpatient settings.

Nucleus: What operational lessons have early adopters learned that can help newer or smaller centers avoid costly inefficiencies and implementation missteps?

ZM: One of the biggest lessons learned is that communication infrastructure is just as important as clinical expertise.

Early adopters have demonstrated the importance of clearly defined ownership models, escalation pathways, and standardized operational workflows before patient volume increases.

Another key lesson is that outpatient CGT delivery requires significant upfront planning around toxicity surveillance, caregiver education, rapid admission pathways, and interdisciplinary coordination.

Programs that invest early in process mapping, simulation exercises, and scalable staffing models are often better positioned to avoid downstream inefficiencies and staff burnout.

Nucleus: How should pharmacy, technology, and quality management teams be integrated into CGT programs to support accreditation, toxicity management, and real time coordination?

ZM: These teams should be embedded as core strategic partners within the CGT program rather than functioning as downstream support services.

• Pharmacy plays a critical role in therapeutic oversight, operational coordination, toxicity management, formulary strategy, and transitions of care.
• Technology and informatics teams are essential for building EMR-based workflows, real-time communication systems, and data capture processes that support both patient safety and regulatory requirements.
• Quality teams provide the framework for accreditation readiness, process standardization, deviation management, and continuous program improvement.

The most successful programs create highly integrated operational ecosystems where these groups collaborate continuously rather than intermittently.

Nucleus: What strategic and financial models can institutions use to navigate reimbursement complexity while ensuring equitable patient access to CGTs?

ZM: Institutions should develop multidisciplinary financial models that account for payer variability, prior authorization timelines, product acquisition costs, inpatient versus outpatient reimbursement differences, and supportive care utilization. Dedicated financial navigation teams and early payer engagement are increasingly important as therapies expand into broader patient populations.

Strategically, programs must balance operational efficiency with equitable access, particularly for patients who face geographic, socioeconomic, or caregiver-related barriers. Long-term sustainability will depend on institutions creating flexible care delivery models that align reimbursement realities with high-quality patient outcomes.