With the first potential COVID-19 vaccine(s), anticipated as soon as late this year, supporting pharmaceutical manufacturers and distributors to ensure a strong continuum of efficient supply chain logistics will be essential.
Logistics plays a vital role in vaccine development and delivery. Market demands, international travel and supply chain restrictions, and temperature-sensitive products, add further complexities into the mix.
UPS Healthcare president, Wes Wheeler, discusses logistics’ role in vaccine development and linking healthcare workers and patients to medicines, as well as how the pandemic is impacting pharmaceutical supply chain logistics, and challenges that may arise with the supply and distribution of a potential COVID-19 vaccine. –KB
Contract Pharma: How is the pandemic impacting pharmaceutical supply chain logistics?
Wes Wheeler: Complexities in the pharmaceutical supply chain have been magnified by the COVID-19 pandemic. Early on in the outbreak, international travel and supply chain restrictions hampered the throughput of essential medications, equipment and test kits, leading to supply shortages worldwide. Market demands will continue to drive a need for certified healthcare-dedicated logistics services, including strict environments for temperature-sensitive products such as vaccines. The pandemic is reshaping the healthcare industry, and is heavily impacting global supply chains requiring unprecedented levels of logistics and distribution support.
UPS Healthcare worked closely with federal agencies and global healthcare customers like QIAGEN, AmerisourceBergen, Amgen, Edwards Lifesciences, Dr. Reddy’s, Vault Health and others. The urgent mission was overcoming supply chain challenges and flight restrictions to expedite test kits, personal protection equipment, ventilators, ICU monitoring units, medical devices, and time- and- temperature-sensitive pharmaceuticals to hospitals and markets around the world. We expect to lend the same extensive support when it is time to distribute vaccines to populations around the globe in the coming months.
CP: What role does logistics play in vaccine development and delivery? How important is packaging?
WW: Logistics play a pivotal role in this battle against the coronavirus, including vaccine logistics, when it comes to that. Currently, our clinical subsidiary, Marken, is working with several pharmaceutical companies and their partners as their vaccines and treatments enter the clinical stages of development. Our involvement in the clinical phase gives us valuable data on how to manage the logistics for these complex products.
Vaccines, like most sterile products, are usually packed by the customer according to strict FDA and other regulations. For outer packaging, vaccines that require -80°C handling are shipped in validated thermal coolers using dry ice. Vaccines that are shipped at -20°C or 2-8°C are shipped in validated thermal coolers that can be maintained for up to 96 hours. Vaccines shipped at -2°C to -8°C are packed in validated thermal containers that are either disposable or re-usable utilizing phase-change material. Handling such sensitive, critical products, whether specimens during clinical phase or vaccines, including mRNA types, once ready for market, requires smart, specialized networks and temperature controls that are optimized to mitigate loss, damage or spoilage. In the battle against this virus, understanding and planning for various supply chain complexities will make all the difference for a successful vaccine distribution campaign.
CP: What challenges do you anticipate with the supply and distribution of a potential COVID-19 vaccine?
WW: Among the challenges facing the industry will be prioritizing vaccine distribution - determining who gets the vaccine in what order, and secondly, perhaps what rationed amounts each of these demographics or countries receive. With manufacturing, one consideration is the availability of glass and other raw materials for billions of vials. On the logistics side, maintaining strict temperature controls while mitigating loss, damage and spoilage will be of paramount concern. The sheer uncertainty of vaccine development and approvals right now is a major consideration since planning detailed supply chain protocols for storage and distribution are simply “what if” scenarios at this point. Essentially, supply chains must plan for any and every scenario, and build in contingency plans to avoid supply chain failures.
Internationally, countries will need to adopt collaborative and cooperative cultures like never before surrounding COVID vaccine distribution to avoid regulatory or political bottlenecks. Demand likely will outpace supply with initial vaccine deployments, so we cannot afford to lose one vial because lives will depend on supply chains being prepared, efficient and agile end-to-end on day one.
CP: What services are being leveraged to alleviate these hurdles?
WW: UPS is in discussions with U.S. Health & Human Services, the Operation Warp Speed team and our partners to think through various complexities, and explore how to minimize supply chain gaps and challenges across the nation and globally. UPS Healthcare recently brought online more than 1.5 million additional square feet of cGMP healthcare distribution space in key global markets, including the UK, Hungary, Shanghai and the U.S., and installing two freezer farms in Louisville, Kentucky, and Roermond-Venlo, the Netherlands, for vaccine storage and distribution. The freezers will be capable of holding therapies under quarantine, prior to FDA issue of an Emergency Use Authorization (EUA). We expect that some of the vaccine developers will manufacture at risk, ahead of EUA, in anticipation of approval.
UPS Premier, our priority handling service, will play a key role in enabling urgent flow paths, monitoring and contingency actions. This service will give our stakeholders superb visibility and control over critical COVID-19 vaccine shipments, taking the guesswork out of shipment status and condition anywhere in the world. Furthermore, new command centers in Louisville and Roermond will be nerve centers to track shipments using GPS markers along the supply chain, and staffed to monitor for temperature deviations, intervention and re-icing protocols if needed to keep products safe and stable.
CP: What does direct-to-patient logistics entail in these times?
WW: When clinical sites and hospitals needed to refocus on COVID-related treatments and testing, Marken’s services allowed patients to continue with their trials through home visits. Direct to/from Patient (DTP/DFP) and home healthcare services provide solutions to keep clinical trials going, while maintaining patient safety by shipping treatments directly to participants’ homes.
Through DFP services, biological samples are retrieved from a patient’s home and sent to laboratories for testing. Combining DTP services with home healthcare services allows patients to respect the confinement guidelines of their location while continuing to participate in their clinical trial, which is key in the development of critical therapies and vaccines. Prior to the pandemic, Marken was operating direct-to-patient in 57 countries. Now, that service has been provided in over 80 countries. After sponsors secure permission to include DTP services into their protocols, Marken coordinates logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the U.S. and Latin America.
Wes Wheeler is president of UPS Healthcare, the company’s first vertical business unit and is specifically focused on pharmaceuticals, medical devices, wholesalers, retail distributors and customers that store or move regulated healthcare products. Prior to taking this role in 2019, Wes was the Chief Executive Officer of Marken, a leading global supply chain service provider to the clinical supply chain industry serving all of the leading pharmaceutical sponsors, central laboratories and contract research organizations in the world.
