The COVID-19 pandemic impacted nearly every aspect of the cell and gene therapy supply chain. That required companies throughout the cell and gene therapy industry to pivot quickly to continue to deliver for patients. Be The Match BioTherapies® was no exception. Ray Hornung is the Senior Manager of Logistics and Emergency Preparedness for Be The Match BioTherapies and the National Marrow Donor Program®/Be The Match®. He shares key learnings from the past 18 months, the changes that came from those learnings and which changes he thinks are here to stay.
What continued impacts have you seen on the cell and gene therapy supply chain over the last 18 months?
Foreign travelers not being able to enter the U.S. has had a ripple effect on the cell and gene therapy supply chain. It impacts our ability to use some of our transport partners to assist with hand-carry products that come into the U.S. It’s also limiting the number of flights available. International flights are about 70% of what they were in early February 2020 and airlines are using smaller aircraft for those flights. That impacts the cargo capacity that’s available. For products that are shipped, like cryopreserved products, cargo capacity is much more competitive. Everyone books their products at the highest priority, which means nothing has priority. Everything has the same standard of loading once it gets rendered to the airline cargo handlers. Then it’s a question of, “Is my product going to get on the plane?”
What steps has Be The Match BioTherapies taken to keep cell and gene therapy products moving internationally?
We leveraged the relationships we already had in place to develop a new model for transporting goods. About a quarter of our products start in the EU for use by U.S. patients. Those products would have been hand carried from an international location to the U.S. We have long-standing partnerships with many international transport companies. We developed a hub-and-spoke program with them. In about a week, we were able to nail down a process that we have continuously improved since then. European couriers pick up the products from a collection site and bring them to Frankfurt, Germany. We transfer the chain of custody and the products get sent on a cargo flight to a hub in the U.S., typically Chicago. Our U.S. couriers pick the products up in Chicago and transport them to their destination. We’ve moved well over 2,500 cellular shipments that way. We have a new model for transportation that we will continue to use into the foreseeable future. In addition, our relationships with U.S. Customs and Border Patrol, the Transportation Safety Administration and the U.S. government were key. Those relationships allowed our couriers to travel to places that others could not. As far as we know, we are the only organization that was able to get a blanket exemption from the federal government that allowed foreign couriers to come into the U.S. We used this on a limited basis in cases where we couldn’t get the product to the U.S. fast enough using the hub-and-spoke model or U.S. couriers. That success wouldn’t have been possible without having those long-standing relationships in place pre-pandemic.
What impact did the COVID-19 pandemic have on the number of transports Be The Match BioTherapies completed for its cell and gene therapy clients?
I think the answer will surprise a lot of people. At the start of the pandemic there was concern everything would stop because all the resources would be devoted to COVID. That’s not what we’ve seen. The number of transports for our Be The Match BioTherapies clients has gone up 79% year over year from fiscal year 2020 to 2021. The year before that, it doubled. We expect to see continued growth in cell and gene therapy operations worldwide. There’s more and more development occurring, and more products being approved for commercial use.
What practice changes do you anticipate will be needed post-pandemic to keep up with the growth in cell and gene therapy operations?
We see standardization as one of the keys to future success. How do you streamline some of these activities so we can help clients get their products to patients sooner? For example, we have extended relationships with great partners like Lonza and Cryoport. We can integrate our systems with theirs so we already have a standard solution we can provide the clients. If they are willing to accept that solution, we can expedite the time for them to start their clinical trials. That’s really important because time is money. Time is a resource that we can’t get back. You need to make the best use of it going forward. It’s no secret that collection slots and manufacturing slots have a limited capacity. The cell and gene therapy industry will need to rely on partners, like Be The Match BioTherapies, that have the relationships and ability to synchronize donor or patient starting material collection with collection slot and manufacturing slot availability. Our Cell Therapy Supply Chain Managers are really great coordinators when it comes to that. They work with my team of Logistics Coordinators to make sure we can get a transport where it needs to go in the right condition and at the right time. Be The Match BioTherapies also operates an extensive collection network so if you have a donor or a patient that needs collection, there’s a higher likelihood we can get that person into an apheresis center somewhere in our network so you’re not burning that manufacturing slot you had to secure two months ago. That extensive collection network also played key roles throughout the COVID-19 pandemic. Many apheresis centers are located in hospitals. When they were being overwhelmed with COVID patients and had limitations on collections, we had other centers we could turn to. There obviously was a lot of concern about flying donors into a COVID-19 hotspot—or traveling long distances at all. That extended network allowed us to avoid those hotspots and allowed people to donate at a center closer to home. In fact, we reduced the distance donors had to travel to a collection center by 30% in the early months of the pandemic. It all comes back to relationships. We’re fortunate we can leverage our partnerships and our capabilities to be able to service all different client needs.
What is the biggest lesson learned during the COVID-19 pandemic that would be important for people in the cell and gene therapy industry to know?
You must always be looking forward. You can’t get to where you want to be using the same processes that got you to where you are today. You need to be able to innovate and leverage your relationships so the allogeneic and autologous therapies you are developing can follow that exciting path towards delivery.
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