A well-designed cell and gene therapy supply chain is critical to patient care. Managing the cell therapy supply chain is a mission-critical industry skill. Yet, no matter how well designed your supply chain is, human-based therapies are subject to variability at each stage of delivery. At Be The Match BioTherapies®, we make sure our team of experts is always ready to take action, whether it’s responding to a natural disaster or a change in patient health-status impacting delivery.
We sat down with Ray Hornung, MBA, MBCI, CEM, CBCP, who spent 23 years on active duty in the Army performing operations and logistics, and manages the Logistics and Emergency Preparedness team at Be The Match BioTherapies and the National Marrow Donor Program® (NMDP)/Be The Match® to learn what it takes to ensure starting material and cell therapies arrive on time, every time.
Q: Your parent organization, the NMDP/Be The Match, is known for its work in managing allogeneic stem cell transplants for patients across the globe. But your established Logistics program is also built to support the many new cell and gene therapies in clinical trials and commercial use today. How does the experience that Be The Match BioTherapies has gained through the NMDP/Be The Match benefit cell and gene therapy developers?
Orchestrating cell therapy logistics is more complicated than most people realize when they first enter the cell and gene therapy space. Fortunately, we have over 30 years of experience delivering the first cell therapy, stem cell transplant, through the NMDP/Be The Match.
These shipments are life critical—whether they’re for a patient having a transplant or a newer therapy like CAR-T—and they can’t be replaced. When cells are collected, they’re live cells with a short window to get them delivered.
For patients waiting for those cells, it’s their last opportunity at another chance at life. There is no room for error.
All the work we do is for naught if we can’t deliver the product in the condition it needs to be, where it needs to be, on time.
We’ve learned to overcome challenges inherent to shipments for cell and gene therapies, and we’ve done so more than 92,000 times. For almost any anomaly, we’ve seen something similar before and we’ve found a way to overcome it to save someone’s life.
Experience is a big benefit for cell and gene therapy developers, because human-based therapies are so different from pharmaceutical drug therapies. By working with our team, therapy developers don’t need to worry about how they’re going to move starting material or the final therapy from one location to another. They can rely on us for transport. Building this expansive infrastructure is extremely costly and requires specialized expertise, so why not leverage the well-oiled machine we’ve run properly for more than 30 years?
Q: You’ve described your team as an orchestra working together in concert to make sure each cell therapy product is delivered where it needs to go, when it’s expected to get there, and in the condition and temperature it needs to be in. Tell us about the orchestration involved in each cell therapy product delivery.
It starts before cells are even collected from a donor or patient. Our Case Management team oversees the entire process – from the time a patient or donor is identified, through the collection and delivery of the cells to a manufacturer and ultimately, the final delivery of the therapy to a patient.
Our logistics team is in regular communication with our case managers to discuss transport and other issues impacting operations, like case delays or rescheduling. They’re also involved when the unexpected happens or if something needs to change in the transport plan due to circumstances we can’t control, like the weather.
About half of our shipments have an international component – and when we say international, we mean everywhere, it’s not just Europe. It could be South Africa, India, Singapore, China, Korea, Japan, Argentina or Chile, just to name a few.
Because of that international component, our customs specialists are critical members of the team. They deal with customs issues as they arise. All of these cell therapy products are commercial goods. There are duties that have to be paid and specific documentation that’s needed.
We also have logistics associates who specialize in cryopreserved products. If we need a dry shipper and one is not available in the needed location, they know where to get one to ensure an on-time delivery.
We have logistics coordinators who do the heavy lifting. They work with a myriad of partners to make sure we have the right solution for each shipment, as well as contingency plans, to make sure product gets where it needs to go when it needs to get there.
We have someone available 24/7 to ensure the people transporting our products have the knowledgeable support of the organization behind them.
Q: You mentioned there are times delivery plans need to change due to circumstances outside of your control. What are some examples of unexpected challenges and how you were able to overcome them?
Every day we have shipments go exactly as we originally planned. However, there are many times we need to rely on the relationships we’ve developed over the years to ensure products get to their destination.
One example is the days following Sept. 11, 2001. As we all remember, U.S. airspace was closed following the attacks on the World Trade Centers and the United States Pentagon. However, there were patients whose lives depended on the time-sensitive delivery of their potentially life-saving cells. By leveraging our relationships with the U.S. Government, we were able to obtain special clearances to complete the deliveries by plane.
You never know when situations like this will arise, but unfortunately, when someone’s life relies on your product, you need to ensure that you have the systems, processes, and relationships in place to reroute, problem solve, and ultimately, deliver.
Our relationships with the emergency management community across the country have been instrumental to our success in continuing to deliver products when natural disasters occur.
Hurricane Florence, which hit the Carolinas in September 2018, is a recent example of the collaboration with the emergency management community, as well as U.S. Customs and Border Protection.
We needed to get product to a patient in the Carolinas who was waiting for a transplant. The courier, who was coming from Europe, was scheduled to get in early Thursday afternoon in New York and take another flight to the Carolinas. The hurricane was expected to hit the coast at 2 a.m. Friday morning, and the interstates going towards the coast had all been reversed for mandatory evacuation.
Through our relationship with the South Carolina State Emergency Operations Center, we tapped into our contacts and obtained permission from the State Highway Patrol to drive to the transplant center on the coast.
Once we had that permission secured, we changed the courier’s itinerary to fly into an airport in the Carolinas. That meant we were using a different port of entry than originally planned, so we made calls to Customs to make sure the product could get into the country and commercially released.
A car service was waiting for the courier at the airport. They drove five hours on an alternate route with a pass from the State Highway Patrol to go through police roadblocks. They successfully delivered the product to the transplant center for the patient, and then immediately turned around to leave the area before the hurricane hit.
These are just two examples of the steps we take to make sure we deliver products where and when they’re needed. That’s our promise, and what we come into the office each day to do: to save lives through cellular therapy delivery.
Q: Those relationships and experience truly matter when it comes to cell and gene therapy logistics.
They absolutely do. And that’s the biggest advantage cell and gene therapy companies have when they tap into our expertise. We have proven experience and extensive relationships that have continually evolved as the cell and gene therapy landscape has expanded.
I don’t think there is another company out there providing this level of experience to make sure the right product gets to the right patient, in the right condition, at the right time.
We understand it’s not just any product. A person’s life depends on it, and we treat every shipment this way.