Putting Vaccine Supply Resilience To The Test: The Last Mile

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

This article is the second in a two-part interview series with Francisco Mazzei, Pharm MBA LSS, director of global clinical supplies FSP solutions at Thermo Fisher Scientific (TFS). In it, Mazzei reveals how the centralized role of clinical supply drives resilience in global vaccine programs.

If resilience is designed through clinical supply strategy, integration, and foresight, as Part 1 in this series explains, it is realized in execution. Part 2 turns from frameworks to practice, exploring how resilience transfers to daily operations through AI and technology, human oversight, logistics, and last‑mile execution – proving its consistency across complexity, rather than in isolated crises.

AI, Automation, and the Human Factor

In daily operations, the value of AI and machine learning to support supply resilience lies less in predictive potential and more in how the technologies are governed, validated, and applied at scale by clinical supply teams.

“Clinical supply chain leadership looks very different than it did just five years ago,” observes Mazzei. Teams are increasingly relying on advanced technologies, artificial intelligence, and integrated systems to drive smarter, faster decisions. These capabilities “make it possible to reach the next level of efficiency and innovation, ultimately driving a positive impact for patients and society,” Mazzei says.

In fact, per Mazzei, AI is already delivering value by automating routine tasks — documentation, archiving, and data extraction — freeing professionals to focus on higher‑value work. Technologies such as temperature and geolocation tracking also strengthen supply control when properly configured.

Yet, resilience depends on more than tools and tech alone. “Certain attributes — effectiveness, quality, sustainability, and resilience — cannot be delegated entirely to AI,” Mazzei emphasizes, adding that data quality, governance, and human oversight remain foundational responsibilities of clinical supply leadership. He urges realism alongside enthusiasm. “There’s a strong push across the ecosystem to use AI and machine learning,” Mazzei says. “That’s positive; but we also need to be realistic. Before artificial intelligence comes human intelligence, and after that comes validation intelligence.”

In other words: AI can support supply continuity, but it cannot replace human judgment.

Cold Chain Innovation and Persistent Risk

Cold chain innovation illustrates how resilience planning becomes operational reality. The pandemic provides a strong example; it forced innovations in packaging and logistics to make vaccines requiring frozen and ultra‑cold conditions available globally at scale. In cases like these, resilience is critical because the stakes are so high if deviations occur.

“The cold chain industry has evolved significantly in recent years,” Mazzei observes. “We now have solutions that didn’t exist five or six years ago.” These include tools for tracing and tracking; the ability to integrate and monitor multiple variables within the same device – e.g., location, humidity, movement, gases/particles, etc. – in addition to temperature; and materials and configurations that are more environmentally friendly, that use less energy, and that more precisely indicate statuses, risks and trends through digital twins.”

As a direct consequence, per Mazzei, adjacent industries have emerged and are rapidly growing, with high levels of specialization. “Examples include digital cold chain management providers, specialized reverse logistic companies, and patient logistic support partners.”

While specialized preparations can be made, risks still persist ranging from transit delays and power outages to human error at sites. But overall, Mazzei reports that technological advances have reduced the number of supply plan deviations. In fact, when problems occur, according to Mazzei, they are often due to communication gaps rather than technical failures.

The Last Mile: Where Resilience Is Truly Tested

After strategy, integration, and technology have shaped the supply plan, execution shifts to the final mile: the clinical site, where planning assumptions meet site‑level realities.

Clinical sites introduce real-life constraints, variability and risks that expose weaknesses in a supply system – and technology has significantly improved visibility. “Historically, temperature records were reviewed manually on paper,” Mazzei recalls. “Today, technology allows continuous temperature monitoring that can be connected to systems like IRT” – enabling rapid intervention when issues arise.

Operationally, clinical sites are a critical line of defense for supply chain resilience. “Sites need to be viewed as an extension of our GMP and GDP distribution hubs,” Mazzei explains. Here, infrastructure is foundational: proper pharmacy setups, suitable refrigerator and freezer equipment, and appropriate monitoring systems are non‑negotiable.

But infrastructure alone isn’t enough. Training, documentation, defined workflows, and reliable data capture are equally critical. “Our clinical supply role doesn’t end at the depot – it extends to the clinical site and the point of dispensation,” Mazzei says. “The last mile is often where the biggest challenges arise.”

Elaborating, Mazzei highlights that clinical supply was originally viewed as a GMP manufacturing and distribution discipline that ended when supplies were delivered to a clinical site in a GCP environment. “GMP environments are normally more stable and standard than GCP environments (like points of care, hospitals, clinics participating in clinical trials, etc.), with a higher flux of people, suppliers and events,” he furthered. “For these reasons, the last mile requires a different level of management and coordination to avoid miscommunications that can lead to unnecessary deviations and losses.”

“The industry also has a much closer focus on patients and their caregivers, providing a deeper understanding of the product’s use throughout the entire value chain,” Mazzei continues. “This will ultimately impact upstream clinical supply metrics like utilization, waste and lead times in a positive way. Everything is connected.”

With new realities and complexities in the pharma field, more sensitive compounds in development, and new requirements/regulations, per Mazzei, the end clinical supply goal cannot and should not stop earlier than at the proper preparation, dispensation, administration and disposal of the investigational product.

Lessons Learned: Rapid Startup and Large-scale Enrollment

The value of last‑mile execution lies not only in identifying weaknesses, but in revealing which resilience practices can be scaled, transferred, and reused across programs. The last mile of vaccine supply, as Mazzei’s experience shows, revealed lessons that extend well beyond infectious disease to other therapeutic areas and development models.

For example, according to Mazzei, models developed for rapid startup and large‑scale enrollment can translate directly to cardiovascular and metabolic studies. And cold‑chain expertise also applies to oncology, rare diseases, and advanced biologics.

Equally important is the knowledge gained from late‑stage clinical development into early commercial planning. “Practices around routing, storage, pharmacy handling, and site readiness are extremely valuable when products must reach remote locations,” Mazzei says. These insights provide practical guidance for navigating development from early clinical stages through market readiness.

Resilience in a Changing Landscape

Clinical trials don’t happen in a vacuum, though, as most readers know. Consumer behavior, institutional trust, and market dynamics, among other variables, add layers of complexity.

For example, in the U.S., skepticism over vaccines has grown; Ipsos found that between June 2025 and March 2026, public trust in federal childhood vaccine recommendations dropped from 71% to 60%. On a global scale, data tracked between 2015 and 2024 by the Vaccine Confidence Project indicated public confidence in vaccine safety fell across all regions – sometimes by as much as 15 percentage points.

Consequently, public mistrust has hindered research participation. The University of Pennsylvania Leonard Davis Institute showed, based on its paper in BMC Public Health, that when trust in vaccine oversight eroded, fewer people were willing to join vaccine trials.

Despite these indicators, Mazzei remains confident in the long‑term trajectory of vaccine demand. “What we’re seeing needs to be viewed in context,” he says. “During the pandemic, there was an intense push for consumers to get vaccinated. Now it is the opposite.

“What we’re seeing is a temporary response to the previous period,” he continues. “The underlying need for public health solutions remains.” He adds that while regional challenges may exist, they are balanced by strong demand in other parts of the world.

External pressures like these further emphasize why resilience must function in everyday operations, not only in moments of disruption — and why clinical supply must remain actively engaged across the full value chain.

Clinical Supply at the Forefront

In the end, contrary to the claim that invisibility is clinical supply’s superpower, it is the ability to translate strategy into coordinated execution that truly stands at the forefront. Through this integration, clinical supply continuously drives resilience rather than operating as a downstream function. As Mazzei reminds us, the ultimate measure remains simple: “The most important thing is to keep the patient at the center.”

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.