Updated March 27, 2020 (original story follows)
Editor’s note: It’s been just over one month since we first shared how established relationships have helped our organization navigate the impacts of the coronavirus on the cell therapy supply chain. Since then, much has changed.
Just a few days after we posted the story, reports from Italy began pouring in. The impact on human life there, tremendous. Then, COVID-19 cases in the United States began growing. And, in just weeks, life as we knew it stopped.
But what hasn’t stopped is our organization’s commitment to overcome all obstacles to get time-sensitive, life-saving cellular therapy products to patients around the world.
Ray Hornung, MBA, CEM, CBCP, the Senior Manager of the Logistics and Emergency Preparedness team at Be The Match BioTherapies® and the National Marrow Donor Program® (NMDP)/Be The Match®, sat down with us the morning of March 25, 2020.
He explained the tremendous impact of COVID-19 on the cell therapy supply chain. And, how the organization has relied on both experience and worldwide relationships to overcome the challenges and deliver.
The world looks very different today than it did in February 2020. How has the organization been able to continue to manage a global cell therapy supply chain?
My team’s tagline is, “We deliver when you need it most.” Has it been challenging lately? Of course. The operating environment has changed considerably.
When you look at today alone—and it’s only 10 a.m. Central—9,188 flights have been canceled within, into or out of the United States. That’s about 40% of the flights that were on the schedule yesterday that are not on the schedule today.
That makes our work more complicated. We’ve had to implement many of our backup plans because our normal supply lanes aren’t there. But every one of the cell therapy products that we’ve been asked to get from point A to point B needs to get delivered.
We’re leveraging our vendors and other partners to make sure every time-sensitive, patient-directed cell therapy product gets where it needs to go despite the supply chain challenges.
What is the biggest supply chain challenge or obstacle that the NMDP/Be The Match and Be The Match BioTherapies have had to overcome to continue to move product?
There are two pieces to that. We leverage a lot of international couriers that are not U.S. citizens. When the president restricted entry into the U.S. for non-citizens or green card holders, that had a major impact.
When those restrictions first started, we had to replace more than 100 couriers. Typically, if a donor is in Europe and the patient is in the U.S., we use an international courier to pick up the product and transport it to the U.S.
We couldn’t do that. We had to send U.S. passport holders to Europe to pick up the product and bring it back to the U.S.
Fortunately, we have a good relationship with the United States government. Our Chief Legal Officer, Brian Lindbergh, manages our government relations team. They were able to quickly get a CDC waiver just for NMDP/Be the Match. It allows us to have foreign nationals deliver products into the United States on our behalf. That is unheard of right now in the industry.
That was our first hurdle. The waiver was huge in our ability to continue to move product from Europe to the U.S. About 60% of our transports involve an international component. That means we’re either transporting cells from the U.S. to another country or vice versa.
Right now, our biggest barrier is flight ability and the constant changing landscape of flights. Again, just so far today, airlines canceled 9,188 flights within, into or out of the U.S. What do you do when that happens? You manage each transport one at a time giving it the attention that the patient it is intended for deserves.
As an organization, what was the feeling when we started seeing what was happening in Italy and then, of course, the U.S.?
It’s hard to describe, but I think we felt a renewed sense of resolve. In our hearts, we still firmly believe in the mission of our organization—to save lives through cellular therapy. Despite the adversity being thrown our way, we were going to find a way to serve our patients.
You can’t throw up your hands and not deliver. We figure it out. Every day. That’s what we do.
How has the organization gone about managing a global cell therapy supply chain during the COVID-19 pandemic?
We’ve activated our Emergency Operations plans and our Business Continuity plans. We have cross-functional teams that meet many times during the day.
We’re making sure we’re giving attention to all the various pieces that impact our work. Donor availability. Donor travel. Collection site availability. Collection site staffing. Transportation from the collection site to a manufacturing site or an infusion site. And then the delivery requirements at the manufacturing and infusion locations.
There are places that are saying they don’t want couriers to come in because they’re concerned about where they’ve been and what they might be transmitting. So we’re working with all of these different partners to make sure we can still get their patients the product they need without endangering the staff at those locations.
With all of the supply chain challenges, are you still moving the same number of cell therapy products?
We are. In fact, in March, we’ve done more transports for patient-directed products than we did in February. In February, we did 564 transports. We still have almost a week left in March, and we’ve done 609 transports so far.
Part of the reason is because we’ve made operational changes for both patient and donor safety. Previously, we focused on synchronizing patient prep with donor collection. That meant we flew donors all over the country to an apheresis center or marrow collection center to allow for that synchronization.
Now we’re trying to collect donors sooner and more regionally. In most cases, their cells are transported fresh to the transplant center where the cells are cryopreserved. Physicians don’t start the preparatory regimen for patients until those cells arrive.
Given the current environment, we can’t take the risk that a donor gets sick and can’t donate. Or that the cells get delayed in transport and don’t arrive on time for a patient who is immunodepleted.
We also don’t want donors to have to travel more than is required. Many donors have told us that they still want to give but are afraid to travel. They’ve asked that we figure out how they can still donate without having to travel far from home. That’s a pretty concerted effort that our Donor team is working on.
We’ve also seen an increase in the use of cord blood units as a shelf-ready product. If there is uncertainty on whether or not a donor product can be delivered when needed, a lot of clinicians are ordering cord blood units. That way, they can make sure they can still provide that curative effort for their patient.
You mentioned that about 50% of our cell therapy transports have an international component. How have you worked with international partners to overcome international supply chain barriers during the coronavirus pandemic?
Those relationships have been absolutely critical. It is truly an international effort to collaborate with the 40 countries that we deliver or receive products from. We have regular communication with the World Marrow Donor Association (WMDA) emergency response group.
We lean heavily on our international registry partners to be able to keep us informed on what the changing conditions are there and we do the same for them. We need to understand the ever-changing landscape in each country.
We’re reaching out to our partners to make sure they’re doing the same things we do. NMDP/Be The Match led the way in getting a national blanket waiver to transportation for our international couriers. And we’re asking them to do the same thing. Some of them are going to their individual governments to get those same types of permissions.
What are some of the actions that our international partners have taken to ensure that cell therapy products can still get where they need to go, when they need to get there?
In the few days before we received the waiver from the CDC that allowed non-U.S. passport holders to enter the U.S., there was a collection for a transplant patient in the U.S. scheduled in Poland. Many of the borders in the EU were also closing, which meant a courier from one EU country couldn’t go to another EU country.
Saying, “Well, nobody can go in or out so I guess we’re not going to do the collection and transport,” is obviously not the solution. Instead, we collaborated with our partners in Poland and Germany. A DKMS-Poland courier brought the product to a border crossing. DKMS-Poland negotiated with their government so they could hand the product off to a German courier on the other side of the border.
That courier transported the cells to Frankfurt and handed it off to an American courier. The American courier flew back to the U.S. to deliver the cells to a transplant center for the patient.
In the U.K., the Anthony Nolan registry has been a great leader. They established a transfer point near Heathrow Airport. All of the products entering or leaving the U.K. are delivered there. Couriers go to the pick-up point, do the transfer of authority of the product, and then transport the products for delivery to patients.
That way, international couriers don’t have to travel in areas that are difficult to get to and from. And, they don’t have to spend additional time in those countries. It’s been very effective.
It sounds like it has truly been a worldwide effort to deliver these time-sensitive therapies for patients.
It really is. It has to be. I can’t influence the German government, for example, but our partners at DKMS can.
Even with all the work that our partners are doing with their governments, there are times when it’s been difficult for EU couriers to move between countries. If it can’t be resolved easily, sometimes we just have to send a U.S. courier.
For example, German citizens can’t get into Switzerland today. So instead of using a German courier, I sent a U.S. courier to London. The courier will spend the night there, go into Switzerland on the day of collection, receive the product and fly out.
It’s becoming much more commonplace. We have to stay in constant contact with our EU partners to understand the changing landscape. We need to synchronize efforts to make sure we are complying with national restrictions so we can continue to do our work.
At the same time, we’re balancing those restrictions against the needs of our patients so we can get that product out and delivered.
Just last week, we brought 71 fresh donor products into the United States for patients awaiting a blood stem cell transplant. We had 20 donor products that we exported last week. Those numbers don’t include our domestic transports.
Although the transportation system worldwide is fairly fragile, we’re making sure we’re leveraging our relationships to help deliver.
There are companies that can’t do it. We’ve had partners that have existing relationships with transportation companies. Their partners told them, “We’re sorry, we can’t deliver for you.” They came to us. We leveraged our relationships to make sure that, despite all of the movement restrictions that are occurring in the EU, and even in some U.S. cities, we can move product and deliver for patients.
Many states or individual cities in the U.S. have issued shelter-in-place orders to try to limit the community spread of COVID-19 and flatten the curve. The same is true in many countries. How has that impacted the cell therapy supply chain?
Fortunately, right now there is no quarantine, isolation or shelter-in-place order that would not allow donor or courier movement for urgent medical needs. That is an exemption under every shelter-in-place, isolation and quarantine order.
All of these products we are moving are considered urgent medical need. It includes products both for blood stem cell transplant and for our Be The Match BioTherapies clients who are developing autologous therapies.
But we also know that restrictions change rapidly, so we have to continue to understand that. We educate the people who travel on our behalf to help us complete our mission. That includes both donors and couriers.
We want to make sure they understand they do have freedom of movement. We’re also providing them documentation to demonstrate they are exempt from the restrictions. If there is any conflict with local government authorities, they have our contact information. They can call us so we can help resolve that issue and make sure donors can still get where they need to go and couriers can still get where they need to go.
Even today with the Italy lockdown and severe travel restrictions in place, I have a U.S. courier that went to northern Italy to pick up a product, take it out and bring it back to the States. Our couriers understand what those limitations are with travel and they understand the potential for self-quarantine as a CDC recommendation when they return.
But, we have couriers who continue to be willing to carry out this effort, both ones that are Be The Match U.S. passport holders as well as our partners in Europe who provide courier services there as well.
Is it fair to say this is like nothing we’ve seen before as an organization?
Other than 9/11, absolutely. Since 2001, this has been the longest duration incident impacting our delivery capabilities around the world. For sure.
And, in that 19-year period, we’ve easily more than doubled the number of products that we have to move. In 2001, we had a handful of products that we had to move daily. Today, I have some days where there are 45 or 50 products in play just in one day.
The transportation system is very fragile right now. We have a very robust, highly competent Logistics Management team and onsite travel agents to help manage the disruption to the hand-carry transport of cell therapy products.
When a flight gets canceled, I can’t have somebody go stand in line at an airline counter. I need a courier to be able to pick up a phone and get a travel agent on the other end. The travel agents are dedicated to our transports to make sure we get our couriers on the most reliable transportation routes to get those products delivered.
It doesn’t matter what day it is. It doesn’t matter what time of day it is. We’re available 24/7. We’re managing transportation 24 hours a day to make sure gets where it needs to go.
When you look at our organizational response throughout the COVID-19 pandemic, what are you most proud of?
I’m most proud of the fact that we bring experts from across the organization together every day, 7 days a week to make sure any patient that needs a product, gets that product.
Our entire organization is about serving our patients. We have 1,000 people working together to make sure we can deliver. It’s our Donor Contact team. Our Donor Liaison team. Our Case Managers working with transplant centers and Be The Match BioTherapies clients. Our IT team making sure our robust IT systems can keep allowing us to do our work as most of our organization is working from home.
And, of course, our Logistics team is the final piece in that search and procurement process. All of the work that everyone else does is meaningless if we fail to deliver. It’s like an orchestra. Everybody has to play their part so that the end result is what we all want.
It’s not just our team at NMDP/Be The Match. It’s everyone in our Network from our international registry partners to transplant centers, apheresis centers, collection centers, donor centers, recruitment groups, testing labs and cord blood banks.
It’s really our whole Network gritting our teeth, focusing our efforts, putting some mettle into our resolve to make sure that we get it done.
Each day it’s like, “You’re only going to cancel 9,188 flights? Is that all you’ve got? Well, heck, I can still make it happen!” That’s the prevailing attitude not just on my team, but across NMDP/Be The Match, Be The Match BioTherapies and our Network.
Despite the adversity and the rapidly changing conditions, the end goal remains the same. Patients need products and we’re going to deliver.
Original story posted Feb. 20, 2020
When news started circulating about the COVID-19 outbreak that began in Wuhan, China, in late 2019, an organization centered thousands of miles away in Minneapolis, Minn., was watching closely along with many in the pharmaceutical and biotech industries. While everyone was, and continues to be, concerned about the impact on the lives of those who contract the disease, these organizations also had another concern: the supply chain.
But their supply chain concerns were a little different. Pharmaceutical and biotech companies were monitoring the potential impact of the novel coronavirus epidemic on the supply chain for raw materials used in their product manufacturing.
The company in Minneapolis was monitoring the impact to a different supply chain. One that moves time-sensitive cellular therapy products to patients and biotech companies throughout the world on a daily basis.
That organization is our own parent company, the National Marrow Donor Program® (NMDP)/Be The Match®. We’ve spent more than 30 years coordinating logistics for the delivery of more than 100,000 cellular therapies for patients in need of life-saving treatment.
During that time, we’ve gained experience overcoming supply chain challenges for cell therapies. But COVID-19 presents unique concerns.
We sat down with Ray Hornung, MBA, CEM, CBCP, the Senior Manager of the Logistics and Emergency Preparedness team at Be The Match BioTherapies® and the NMDP/Be The Match for an in-depth discussion about these concerns.
He explains how established systems and relationships have allowed us to develop processes outside of our normal scope so we can continue to deliver cellular therapies across the globe.
How did the NMDP/Be The Match and Be The Match BioTherapies respond when you first learned about the COVID-19 outbreak?
We became aware of the new coronavirus disease—now named COVID-19—pretty early on, well before U.S. commercial air carriers stopped flying to mainland China.
As soon as we started to hear about isolation and quarantine areas, we checked in with our partners to verify the current facts and beliefs about the situation. We do that anytime we hear about an incident so we can start to determine how it might impact our operations.
There can be a lot of misinformation, especially early on. Those established relationships with people who can provide reliable information are so important.
What was your biggest concern in how COVID-19 could impact your supply chain operations in delivering cell therapy products to patients in need of a hematopoietic stem cell transplant (HSCT)?
For us, the biggest concern was, and continues to be, freedom of movement. That changes every day now.
We have a product that needs to be delivered from anywhere in the world in 48 hours. There is a very sick person waiting on the other end whose body has been prepped for transplant. That means their immune system has been depleted. The product must get there.
So, how do we make sure our couriers can continue to get from point A to point B on time? We need to be able to get product in and out of all these different countries. There are countries that aren’t going to let you move blood product in and out even though this isn’t a bloodborne pathogen.
(At the time of publication) nobody else has gone to the extent as mainland China for isolation. But there are other countries that are starting to limit the number of flights coming in and out. We need to be aware of where we can and can’t go.
How important are the NMDP/Be The Match’s established relationships with Customs and Border Protection and the Transportation Security Administration (TSA) in situations like this?
All of our relationships are very important so we can make good decisions. For example, we need to understand if there will be any changes to customs clearance for blood-based products.
We have relationships with 42 different ports of entry in the U.S. The officials at those airports could stop us from bringing cell therapy product into the country. So, we have to reach out to all partners to make sure we’re on the same page.
Our partners in other countries can also help us understand any constraints there. All these relationships allow us to plan effectively so we can thread the needle and get those products where they need to go.
For your HSCT supply chain, couriers hand-carry most of your cell therapy products. How does that impact your response to COVID-19?
That also presents unique challenges, but ones that we’re used to overcoming. It’s important to remember that while COVID-19 is making headlines right now, we’re also in the middle of influenza season.
We expect our couriers to be healthy anytime they are transporting product. That means they need to be without a fever for more than 24 hours without taking any type of fever-reducing medication. If you’re sick with virus-caused diseases like influenza or COVID-19, you need to exercise social distancing to prevent the spread of the illness.
This is nothing new. We have always shared this information with our couriers. We will continue to do so well after the COVID-19 outbreak has been contained. Our couriers need to be physically and mentally focused on the delivery of those life-saving stem cells and not distracted by an illness.
Occasionally a courier will call in and say, “I’m really sorry, I have a fever and I can’t go on the trip.” Then we will reassign it. We have mitigation plans in place for that.
We have more than 300 couriers and some partner courier companies who help us move our cell products around the world. Our courier pool is big enough and in such diverse areas of the country and the world that we can make sure we can still move the product despite barriers that might present themselves.
Many countries, including the United States, put travel restrictions in place for people who have been in China recently. Are those restrictions also a factor in your decision on if a courier can transport a cell therapy product for you?
Absolutely. We need to make sure that the couriers aren’t just healthy, but that we don’t use any couriers who have recently traveled to mainland China.
If we used a courier who had been to China in recent weeks, that would put us at great risk for a courier to be quarantined at a port of entry in the U.S. or turned away at another country’s border even if they appear healthy.
Part of our focus now is also mitigation. What happens if a courier gets sick on a trip, for whatever reason, and gets detained for quarantine as they’re bringing the product into the United States? That product still needs to get delivered to a patient.
We’re working with various authorities to make sure that, if that occurs, we can still get access to those cells, make sure the container’s exterior is sterilized and deliver the product to the patient.
How do you stay on top of a situation like COVID-19 where the health and travel impacts are changing almost daily?
We habitually maintain situational awareness of incidents going on around the world. Every day we have teams that are paying attention to potential disruptions and third-party software that helps identify impacts specific to our travelers depending on their locations.
We have a wide variety of resources that we use to assess where impacts can occur to our operations. And, again, our relationships with government organizations like Customs and Border Control, healthcare organizations and the emergency management community are key.
Along with your HSCT supply chain, you also manage the supply chain for biotech companies developing cell and gene therapies. What process changes have you had to make to accommodate their needs?
There have been reports of concerns that the COVID-19 outbreak could impact the supply chain because there are raw materials used in the manufacturing of some products that come from China. However, that does not impact our work with cell and gene therapy companies.
Their main concern is the health of the donor to make sure the donor hasn’t traveled recently to areas impacted by COVID-19 or has close personal contacts who have traveled to those areas. Some companies have asked us to screen donors for that.
That’s not unlike other donor screening questions we’ve added to our Health History Questionnaire when large outbreaks, such as the Zika virus in 2015 and 2016, have occurred.
Any time we’re working with donors or patients, we want to make sure that everybody is well and that everybody has the freedom of movement they need to be able to do their part.
It’s like an orchestra. It’s making sure the donor is well and we have a place for them to go for apheresis or marrow collection. It’s making sure we have a healthy courier who can pick up the product, get through airport security anywhere in the world and deliver that product in 48 hours. And, most important, that the patient is well enough to receive it.
While COVID-19 is in the headlines now, disease outbreaks like this aren’t the only supply chain disruption that can occur. What processes has your team put in place to appropriately escalate your response?
Different incidents require different people from within the organization to be involved. We have an Emergency Operations Plan and Business Continuity Plan in place so we can bring together the right internal experts.
On one end of the spectrum, if I have a courier who gets sick, I’ll assign another courier to make sure the product still gets picked up and delivered. That’s pretty simple.
It’s less simple when China starts to quarantine 40 million people. Or when airlines stop flying to Hong Kong. That’s a much bigger deal.
In this case, we proactively gathered people from our Emergency Preparedness, Business Continuity, Case Management, Logistics and Senior Leadership teams. We needed to understand what activities we had in place that could be impacted and then make decisions on activities we could continue, those that might require additional planning and those that would need to stop.
For example, there are many potential donors on the Chinese registry. Based on the information we were gathering, we had to decide if those donors should still be included in a transplant center’s search results while the outbreak is ongoing.
It was a very difficult decision, but ultimately, we decided to temporarily suppress them from search results. If we can’t get in and out of China or the donor is sick, it doesn’t benefit our patients.
For any issue that arises, there are many ways we can help reduce risk and provide the product that’s needed. It requires a lot of situational awareness. We have to be proactive when we detect an issue.
Experience and relationships seem to be key pieces of managing a supply chain that can reliably deliver in challenging situations.
They are. We’ve invested a lot in staffing and systems to make sure that we can deliver when patients need it most. We take that responsibility very seriously.
We have a large team of professionals who cherish every cell therapy shipment that we’re fortunate enough to be given the opportunity to manage and deliver on behalf of not just clients, but most importantly their patients.
Whether a cell therapy supply chain challenge is common or rare, experience makes a difference in overcoming it. Explore how Be The Match BioTherapies helps cell and gene therapy companies manage cell therapy supply chains.