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Volume 33, Issue 6
The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
The past few years have brought great change to clinical trial logistics, particularly the move to direct-to-patient trial models. Increased development of personalized medicines, including gene and cell therapies, has required closer coordination and collaboration between distribution partners to ensure strict delivery timelines and end-to-end temperature controls. Cold-chain transportation specialists have adapted to these changes, investing in new technologies and programs (Sidebar). But in 2020, the COVID-19 pandemic has presented new and unprecedented challenges. Given the strictures of social distancing, demand for direct-to-patient (DTP) shipments increased sharply, at a time when travel bans were in effect around the world, and commercial airlines had stopped a number of commercial shipping routes (Sidebar).
This article highlights some of the approaches that cold-chain specialists are taking to the limits posed by the pandemic. Sharing their insights with BioPharm International are Sharon Courtney, logistics services manager for Almac Clinical Services; Alex Guite, vice-president of services and alliances for World Courier; Eric Valentine, vice-president of clinical supply services at Catalent, and Ariette Van Strien, president of Marken.
BioPharm: What are the greatest challenges that the COVID-19 pandemic has posed for your programs?
Van Strien (Marken): Internally, our first real challenge when the pandemic began was understanding what we would need, globally, in order for our team members to work remotely at all of our sites. We knew that some (e.g., site staffers, drivers, and warehouse workers) would need to continue to be on-site. We procured laptops and ensured that they were encrypted and made available, quickly. We also optimized scheduling and shifts for safety and efficiency.
Because domestic and international flights and air shipping lanes were interrupted or stopped, we needed to choose alternatives. In some cases, we rented our own charters; in other cases, we coordinated with UPS, our parent company, for alternative flight options for Marken shipments through their network.
In addition, the immediate greater demand for DTP services required us to address important questions regarding our supply of temperature-controlled plastic shippers and GPS trackers, as well as staff training. We rolled out DTP training, which was already in place in approximately 57 countries in 2019, to over 80 countries, qualifying local transportation and supply-chain partners.
We standardized processes to reduce the customization required for each shipment and customer. For instance, we selected one type of temperature monitoring technology, and one standard approach for handling any temperature excursions.
We also focused on key locations throughout the world. For example, in Asia, we chose Singapore as a central point from which to ship products. The greatest challenge was ensuring constant communication with investigator sites. Sites often call in the morning requesting service and normally, we’d complete shipments by afternoon, but, when commercial airlines were down, we couldn’t always arrange things in just a few hours.
Guite (World Courier): Shipping products across international borders has created some logistical hurdles, particularly because certain countries have limited passage to prevent further spread of the virus. In some cases, these challenges have tripled the time it takes to manage a shipment, but we’ve been able to identify alternative routes to ensure that we’re meeting country-specific regulations and preventing delays and temperature excursions. Even as commercial flight availability has been reduced, we’ve been able to maintain air connectivity by booking space on airlines across a range of international carriers, which allows us to pivot based on the latest conditions and product needs. In fact, through our carrier-agnostic approach and contingency planning, we haven’t declined a single shipment, ensuring every patient has access to critically needed treatments.
Valentine (Catalent): The tightening of international borders, restrictions on travel, and a major reduction in airline capacity and frequency have presented the most significant challenges to the clinical supply chain. From a supply perspective, Catalent has been adding buffer stocks of critical materials and components to protect against the risk of stockouts. We have also seen the supply of some commercial drugs used as comparator products in clinical trials tighten up as manufacturers devote more production time to COVID-19 priorities, as well as individual countries designating existing medications as COVID-19 treatments. In these instances, we are working with our customers to alter their sourcing plans and to ensure that they have a robust strategy and sufficient material to support their ongoing trial needs.
From a distribution perspective, social distancing requirements and significant work restrictions in some countries have impacted our facilities’ processes and workflows. To ensure worker safety, we have realigned several aspects of our operations so that we can be flexible to the changes in our clients’ clinical trials, while also being in a position to rapidly accommodate the needs of clients looking to develop products for the prevention and treatment of COVID-19.
For example, due to the restrictions on the number of employees allowed on-site, our Singapore facility has recently moved to a three-shift work force to ensure that we can process all work orders on time, without any impact on ongoing trials.
Courtney (Almac): The pandemic threatens the continuity of supply for vital medications to patients enrolled in existing clinical trials around the world. Quarantines, travel restrictions, site closures and limited site personnel are some of the factors contributing to this increased level of risk.
Changes in patient recruitment levels, study start-up activities, maintenance requirements, and possible changes to the timelines for key protocol milestones are all potential outcomes, as sponsors shift R&D priorities to accommodate the realities posed by the COVID-19 climate. Coupled with this is the level of urgency with which many sponsors are responding to the call to develop vaccines and treatments for the virus.
BioPharm: How are you working with partners to improve results?
Van Strien (Marken): We’ve taken a number of steps (e.g., simplifying onboarding for new clients to allow faster program startup). We have also worked closely with our clients as the guidelines changed in many countries to allow for adaptive trial models, permitting patient home deliveries and Marken’s nursing services to reach patients.
In packaging, we re-forecasted the quantity and types of packaging that we would need to ship temperature-controlled drugs worldwide as the pandemic spread. Many reusable packaging options had to be moved to single use, but we also increased investment in reusable packaging and temperature monitors to ensure safe delivery in all regions around the world, and made sure that the necessary packaging was available in each country in which we operate. Our efforts so far have allowed 80% of staff to work virtually, and prevented any disruption in services.
Guite (World Courier): Recent studies (1) have found that nearly 80% of clinical research study sites have cancelled or put on hold at least one of their current clinical trials. However, we now find that many of our customers are continuing to collect data to support future therapy development. Since the pandemic began, we’ve seen a five-fold increase in daily DTP shipments.In these cases, World Courier manages treatment deliveries to, and sample collection from patients’ homes. We have also supplied our drivers with personal protective equipment and implemented a contact-free pick-up and delivery process to protect the health of our associates.
Collaboration is key when mobilizing quickly during this fluid environment. That is why it is more important than ever for specialty manufacturers to stay in constant contact with their logistics partners. We are constantly looking at our existing systems to enhance the way we communicate and support customers. For instance, with worldwide flight suspensions, we’ve adapted the technology we use to monitor and manage travel to give our teams more line of sight into scheduling data. This change will allow World Courier’s teams to evaluate schedules from over 950 airlines and provide customers pro-active and accurate information about route mapping.
Valentine (Catalent): One of the key changes in demand we have seen during this pandemic is an increase in requests from trial sponsors for clinical site-to-patient (STP) and DTP supply services. It appears that COVID-19 has accelerated the way that clinical trial sponsors, as well as some local regulatory authorities, think about STP and DTP as potential options to support patient needs. It will be interesting to see whether the industry and regulations ultimately change to facitate adoption of these models beyond the COVID-19 pandemic.
Open communication with customers has helped ensure we reduce risk in the supply chain. As an example, we recently had a discussion with one of our suppliers, which needed to alter the processing of heavy shipments in order to safeguard its employees using social distancing. As a result, we are making more frequent shipments in smaller payloads so that multiple workers are no longer required to process an individual container.
Early on in the outbreak, Catalent began an in-depth review of our operations and supply chains, working with our suppliers to consider their supply chains too. That has remained an ongoing process, and to date, we have not identified any significant risk, delay, or concern that may have a substantial effect on delivery of any product or clinical trial supplies. Catalent also formed a multi-disciplinary coronavirus response team made up of senior leaders that reports directly to our CEO. Reaching into all facets of the organization, and continuously monitoring the global situation, this team swiftly executes mitigation activities whenever and wherever they are required.
Courtney (Almac): One way in which we are helping sponsors streamline processes and improve ability is via Almac ONE, which aligns the digital (forecasting and interactive response technology) and physical (packaging and distribution) aspects of supply chain management, which have traditionally been managed in separate silos by separate vendors. Use of Almac ONE has reduced study set up time for several sponsors, with one COVID-19 trial sponsor up and running in just two weeks. In addition, Almac Adapt, our just-in-time manufacturing service, is helping sponsors package clinical supplies with increased agility. Site-support strategies such as remote drug monitoring have also been introduced to maintain blinding and dosing protocols without the need for the clinical research monitor to physically visit the site.
1. Association of Clinical Research Professionals Survey, “Survey Shows One Third of Clinical Trial Study Sites Fear Total Closure; 77% Indicate at Least Some Ongoing Research Trials Have Been Impacted Due to COVID-19,” acrpnet.org, April 8, 2020.
Vol. 33, No. 6
When referring to this article, please cite as A. Shanley, "Finding New Efficiencies in Clinical Trial Logistics," BioPharm International 33 (6) 2020.