How Clinical Supply Drives Resilience In Global Vaccine Networks

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

Invisibility is often hailed as clinical supply’s superpower – because when all the forces align in a drug development master plan, no one notices it. They’re not supposed to. But as most readers know, if stockouts, labeling issues, temperature excursions or delayed releases occur, all eyes turn to clinical supply.

A recent interview with Francisco Mazzei, Pharm MBA LSS, however, highlights clinical supply front and center. In it, Mazzei reveals how the centralized role of clinical supply drives resilience in global vaccine programs. This is especially true as programs intensify in scale, speed, and complexity.

When clinical supply effectively integrates planning and operational functions, this builds supply continuity because it changes how risk is designed for, detected, and absorbed — not just how it is reacted to. In other words: integration turns a set of vulnerable handoffs into a coordinated system that can adapt under stress.

Mazzei is a seasoned clinical supply leader who has helped foster this capability firsthand. He is the director of global clinical supplies FSP solutions at Thermo Fisher Scientific (TFS) with more than 25 years in the pharmaceutical and CRO sectors; including in biopharma and commercial supply at Novartis and Pfizer.

Mazzei’s commercial expertise led him into clinical supply for oncology, diabetes and respiratory trials at TFS – first in Chile, then in other parts of Latin America. Ultimately, his experience expanded into global oversight of vaccine and complex clinical programs.

“My career followed the trajectory of the industry,” Mazzei says. “It moved into biotech, then vaccines – especially mRNA when COVID-19 arrived.” He adds that one effect the pandemic had on clinical trials was the need for specialization in vaccines, since their development incorporates so many factors and populations, requiring strategic coordination on a global scale. In fact, throughout Mazzei’s journey, one theme has remained constant: clinical supply only succeeds when it acts as an integrative force across the development ecosystem.

In this two‑part series, Mazzei first examines how clinical supply integrates processes to support resilience in global vaccine systems. In Part 2, he describes how the tenacity built into the system is realized at clinical sites, extending through the last mile.

Strategic Integration and Population-Level Mindset

Modern vaccine supply strategies span multiple stakeholders, often across companies, systems, and geographies. The role of the clinical supply leader, Mazzei emphasizes, is to act as a true integrator: aligning CMC, clinical operations, regulatory affairs, logistics and distribution, IT systems, data management, and finance around a shared strategy.

The main challenge to successful integration is the high level of fragmentation across the industry, or even within the clinical supply unit itself. According to Mazzei, this is due to the nature of these specialties to work in silos without an “effective exchange” between the parties.

“Anyone who manages the clinical supply chain must be a strong leader to adapt the dialogue and style of exchanges between manufacturers, quality, regulatory, clinical, logistics, lab and data management (to name a few),” he highlights – the goal being to ensure a fluent flux across stakeholders.

To smooth these exchanges, per Mazzei, clinical software has evolved in recent years to incorporate additional business flows into their platforms. “Players traditionally in the EDC/CTMS field have expanded to include other areas like quality management, risk management, file management, safety, supply chain and manufacturing,” Mazzei explains.

Digital dashboards are another tool to collect data from different platforms and sources to show statuses, trends and risks in one place and with one click. “That way, necessary actions can be taken by respective teams depending on the nature of the risk/issue,” he writes.

This integration balances speed, scale, optimization, and full regulatory compliance, building resilience without losing sight of what matters most. “Especially in vaccines,” Mazzei stresses, “the focus is public health and the well‑being of patients and societies.”

With this extensive focus, Mazzei adds that vaccine programs require a fundamentally different supply mindset. Unlike traditional drug treatments, vaccines are designed for broader populations and require massive enrollment to accurately reflect population-level safety and efficacy. Vaccines also are generally administered to healthy individuals rather than those affected by disease.

Like traditional therapies, however, vaccines face aggressive timelines and global distribution under strict regulatory and temperature constraints.

“Vaccines are a very dynamic field,” Mazzei explains. “Clinical supply leadership has to be proactive from the very beginning because clinical supply cannot operate in a silo, as a standalone center of excellence.”

Digital Tech to Enable Proactive Risk Management

Advances in digital technologies have made proactive supply management possible. Mazzei says: “Over the past 20 years, I’ve seen the industry evolve from paper records, phone calls, and fax machines to one system, then two systems, and now multiple integrated systems — especially over the last five or six years.”

This connectivity has reshaped risk management, transforming it from reactive to resilient. “If there’s a temperature excursion or a shipment delay, we can assess risk immediately and understand the implications in real time; whether that’s for the clinical plan, regulatory commitments, or quality,” he notes.

To illustrate, an IRT/RTSM system may be used to track shipments to sites and temperatures during transit. That platform is then integrated into EDC/CTMS and the supply chain management system. “Any event that is logged in the IRT/RTSM – like a shipment delay and/or temperature excursion – will raise an alert to the supply chain system, so a new shipment from the depot can be released,” Mazzei writes.

“At the same time, a flag will pop up within the CTMS indicating a potential impact on visit scheduling. In that way, both clinical teams and supply chain teams will be informed and will take the appropriate actions ahead of regular project team meetings.”

Early Alignment Across Functions

Beyond proactive risk mitigation, building an adaptable clinical supply chain takes true alignment between vaccine supply, clinical operations, manufacturing, and quality – and it begins early, continuing throughout the trial lifecycle.

“It starts with very basic principles: clear, strategic, and transparent communication,” Mazzei says, highlighting the Clinical Supplies Project Plan as the compass. This guideline is integrated with manufacturing plans, overall project timelines, monitoring strategies, and regulatory requirements, which enables resilience to take shape early.

Per Mazzei, the project plan is central to proactive supply management. It functions as a dynamic, digital framework that captures complex inputs from multiple sources, then translates them into executable, adaptable strategies.

Inputs may include:

• Temperature and stability data received from CMC
• Patient visit schedules provided by medical writing and protocol development teams
• Country labelling requirements, supplied by the regulatory affairs group
• Country import/export lead times outlined by trade compliance experts
• Particularities related to indication and patient population and pain points, supplied by medical affairs and patient support groups

From these inputs, an executable strategy for supply chain and logistic workflows can be developed.

“For example, the transit times between depot and site can be aligned with temperature stability data for sensitive compounds, to prevent the risk of frequent excursions,” Mazzei explains. Specific packaging and labelling strategies can also swiftly introduce any new country/language/phrases without the need to start over. “This is because we use either booklet labels and/or a smart combination of fixed and variable texts and/or pool supplies,” Mazzei adds.

So, early partnerships with medical writing, CMC, and regulatory affairs ensure supply strategies align with protocol design and manufacturing realities – while surfacing risks before they escalate. As studies progress, per Mazzei, collaboration with clinical operations becomes critical to managing timelines, milestones, and dependencies.

In addition, ongoing engagement with procurement, finance, and project management provides visibility into material availability, cost implications, and their downstream impact on trial execution. This early oversight is where supply preparedness is built, rather than recovered.

As conditions change – e.g., site country mix, country regulatory requirements, enrollment rates, retention rates, IP use at sites, inclement weather, geopolitical events, and many others – scenarios can be tested and decisions made quickly; a capability that’s essential to global vaccine trials.

“We now have advanced tools and technologies that allow us to simulate scenarios by creating digital twins to test or challenge what we need,” Mazzei highlights. “This ensures our supply chain is robust and resilient enough.”

He adds, however, that researchers must be mindful that nothing is “fixed” – even the most definitive baseline scenario will be affected by unpredicted conditions. But to Mazzei, it’s not about avoiding the change; it’s about having the capacity to react and adapt to that change without sacrificing quality, speed or efficiency.

“For instance, when we are framing a supply chain and logistics workflow for a sensitive biologic compound in early clinical development, and we need to decide on key specifications like packaging size, supply/resupply timelines, and routes of deliveries, we can start building our operational model with certain assumptions and the data available to us,” he describes.

“Specific scenarios can be simulated to factor in drastic events like wars, earthquakes, extensive delays, etc., and see the impact on timelines, sites and patients as they would happen. We can play with different conditions depending on the particularities of the investigational product, protocol, location and phase,” he continues. “The starting point will then be re-validated once more data is available, ensuring the supply chain and logistic plan remain strong, efficient, sustainable and resilient enough.” 

The measure of success, Mazzei believes, is adaptability: the ability to take complex inputs from across the organization and continuously refine the supply strategy as conditions evolve.

With these clinical supply strategies in place, Part 2 of this series shifts from design to execution — exploring how technology, human oversight, logistics and last‑mile performance translate resilience from planning into day‑to‑day practice across real‑world conditions.

Francisco Mazzei is a clinical research leader with more than 25 years of experience driving innovation across the pharmaceutical and life sciences industry. As Director of Global Clinical Supplies FSP Solutions at Thermo Fisher Scientific, he partners with sponsors to deliver Phase I–III studies with a strong focus on quality, compliance, and operational excellence — always with patients and society at the center, aiming to improve quality of life and create meaningful impact. Recognized as a business transformation agent, Francisco has led and enabled solutions across a broad range of areas, including systems, manufacturing and laboratory operations, supply chain and logistics, clinical operations, regulatory and compliance, and market launch and access. Francisco holds a professional degree in Pharmacy & Chemistry at the University of Concepción, Chile, and an MBA in International Business at Gabriela Mistral University, Chile.