There is no question the COVID-19 pandemic has disrupted cell therapy logistics like never before. Supply chain challenges are no longer the exception, but the norm. So how can companies overcome autologous cell therapy logistics challenges to deliver time-sensitive source material and manufactured therapies on time?
It’s not easy in our current environment, but it can be done. Success depends on an experienced team with the relationships in place to navigate obstacles that seem insurmountable.
We sat down with Be The Match BioTherapies® team members Erin King, Cell Therapy Supply Chain Case Manager, and Alysia Maxwell, Logistics Coordinator, to discuss managing cell therapy delivery plans in the time of COVID-19. They explain how they support cell therapy developers to overcome COVID-19 challenges and deliver cell therapies to patients.
Before we talk about the challenges you’ve encountered during the COVID-19 pandemic, can you explain how you work with clients—and each other—to coordinate the movement and delivery of cellular starting material and manufactured cell therapies?
Erin: As a Be The Match BioTherapies Cell Therapy Supply Chain Case Manager, I am the single point of contact for all stakeholders from start to finish. I see the whole picture of every order and help coordinate all aspects of a collection and delivery.
For an autologous cell therapy, for example, I work with the apheresis center to determine when a patient can get in for the collection. I connect with the manufacturer on when they can accept the product. I’ll work with the clinical site to understand the patient’s treatment timeline.
I know the apheresis center and clinical site’s requirements, how quickly products must be delivered, the needed paperwork, who needs to know what information, and how each shipment fits in with the patient’s overall treatment plan.
I take all the information from multiple parties and send the key pieces to the right stakeholder at the right time. Internally, that is our Logistics team. Alysia and I communicate very closely to make sure we get the product delivered efficiently and correctly.
Alysia, as a Be The Match BioTherapies Logistics Coordinator, it is your responsibility to manage all legs of transport for a product. Those transport legs actually start sooner than most people would expect.
Alysia: That’s correct. It starts before a product is picked up from an apheresis center or manufacturing site. Our first leg of transport is getting the empty shipping container to the site. That could be a cooler or a cryo shipper depending on if the product must be transported fresh or frozen.
Then there is the actual product transport leg, which is what most people think of when they’re thinking about allogeneic or autologous cell therapy logistics. That product could be the source material for cell therapy manufacturing or the manufactured therapy.
After the product is delivered, most shipping containers need to be returned, so that is another leg of transport.
For every leg of transport, we’ll determine which of our courier service partners is the best option. We schedule all the legs of transport and courier services, make sure the correct paperwork is in place and, of course, make sure the product is safely delivered in the requested timeframe and within the agreed upon parameters.
Erin: Once Logistics has scheduled everything, I receive the itineraries, commercial invoices, airway bills, and container tracking numbers from them. I’ll send the information to the right stakeholders and confirm that all the dates and timelines will work with the overall big picture and patient’s treatment plan.
Throughout the process, all stakeholders know they can reach out to me with questions, concerns or changes.
How has the COVID-19 pandemic impacted autologous and allogeneic cell therapy logistics?
Alysia: From a logistics perspective, changes in flight schedules have had a major impact. Since the COVID-19 pandemic started, about 80% of domestic flights have been canceled. Flights are always a challenge in the movement of time-sensitive cell therapies, but now we have even fewer options.
For autologous cell therapy logistics in particular, patient collections may take longer than expected which delays the pick-up time. That happens quite often. We understand why. It just makes the logistics tricky because we don’t have as many—or sometimes any—options for a later flight.
Erin: There are so many last-minute changes and flight cancellations right now. We’ve had situations where a product is being picked up and the flight gets canceled. When that happens, our Logistics team works on rebooking the flight. They give me the information and I get it out to the key stakeholders so they know when to expect the product.
It’s critical to communicate any changes to the client or sponsor and other stakeholders as soon as we have it. There are very specific dates and times that manufacturers can accept product, when they can pack it out and when the patient can come in to receive their therapy.
That’s always true. But what we’re noticing with COVID-19 is that sometimes there is not regular staffing at the manufacturing or clinical sites. So, it’s really important to give them a heads up when a courier is coming to pick up product or when something is going to be delivered. That way they can make sure they have staff available that can process the product that is coming in.
In the midst of the COVID-19 pandemic in April, you worked with a cell therapy developer to transport three autologous cell therapies all on the same day and all starting and ending in different locations. How did you work together with the company, all the pickup and delivery sites, and courier services to overcome logistics challenges?
Erin: One of the biggest challenges with the shipments was the part of logistics many people don’t think about—getting the shipping containers to the manufacturers and collection center. For these shipments, we had about a week’s notice that they were going to occur. While that’s not necessarily unusual, it does make it more challenging during COVID-19.
In this particular situation, we needed to pick up two manufactured autologous therapies from manufacturing sites and deliver them to clinical sites. There was also a patient collection happening that day. We need to pick up the patient’s cellular starting material from an apheresis center and deliver it to a manufacturer. As you mentioned, all the pickup locations and delivery locations were different.
We always like shippers to arrive a minimum of one day before pickup to ensure it can happen as planned. In this instance, the pickups were occurring on a Monday. Originally, the shippers were scheduled to arrive at the two manufacturing sites Friday, but both deliveries were delayed. In addition, two shipping containers needed to get to the apheresis center, which was also in a different city.
Our Logistics team worked through the weekend to make sure everything got where it needed to go.
Alysia: Because the shipping containers weren’t going to arrive on Friday during normal business hours as planned, we had to coordinate with the sites to make sure staff could be available to accept them.
One of the cryo shippers also didn’t make it out of the courier service’s hub in Memphis on time, so it didn’t arrive until Monday morning. Fortunately, all of the shipping containers arrived where they needed to go so pickups could occur on time. I just have a little more gray hair now!
Did you encounter any additional logistics challenges getting the products from the pickup sites to the delivery sites?
Alysia: There were a few additional logistics challenges that we had to overcome. The first one happened when we were scheduling the flights for product delivery.
The courier partner we selected for the product movement provided me with an itinerary that scheduled the product to arrive a day later than we wanted it to get there. I connected with them right away and stressed the urgency of figuring out flights so the delivery could occur on time. They came through for us.
Erin: But that wasn’t the end of it. Remember, there was starting material or therapies being picked up at three different sites in three different cities. All three flights that those products were on ended up getting delayed.
There were a lot of last-minute changes and new flights and itineraries coming from Logistics to me and then me getting those out to all of the different stakeholders. Fortunately, Alysia and her colleagues were able to rebook the flights and all the products were delivered in the requested time.
Alysia: There were a lot of moving pieces that needed to work in harmony with each other so we could get the products out the door and on their way. With COVID-19, there are only a certain number of flights out of a city each day, so we don’t have as many to choose from.
We were constantly checking, “Did the shipper get picked up and on the truck?” “Is the product at the airport?” “Did it make it on the flight?” “Did it arrive at the site?”
Those are most of our challenges in Logistics … just trying to make sure everything is where it needs to be when it needs to be there. It’s more complex than most people realize.
Navigating a time-sensitive cell therapy supply chain during the coronavirus outbreak (blog)
Managing donor collections during the COVID-19 pandemic (blog)
Are the autologous cell therapy logistics challenges you experienced unique to COVID-19?
Erin: A lot of what we’re doing during COVID-19 are things that aren’t unusual. All the calls that we’re getting at 3 a.m. The changes in flights and pushback in pickup. The short timetables. It’s not new. We do this all the time.
The main difference is the instances of delayed flights and canceled flights. There is a greater volume of those changes right now.
But these kinds of changes happened before COVID-19 and they’ll happen after. That’s why we have someone on call 24/7. Stakeholders can call one phone number. They reach a Cell Therapy Supply Chain Case Manager any time of day, any day of the week.
Our job as Cell Therapy Supply Chain Case Managers and Logistics Coordinators have never fit in the 9 to 5 parameters. That’s especially true in the midst of COVID-19.
Our team members work unconventional hours to make sure that products are being delivered. We are online in the evenings, early mornings and checking in on weekends to make sure we have the most updated information on flights, product movements and new potential orders. We work together to answer questions from clients about potential flight options so they can schedule patients for collections and lock down manufacturing slots at CMOs.
The Cell Therapy Supply Chain Case Manager role is the one-stop shop for our clients to ask questions, escalate issues, send along requests and receive information from us. It always has been and it always will be.
How does working with a company that offers a managed logistics solution—like Be The Match BioTherapies—help companies successfully navigate autologous cell therapy logistics challenges?
Erin: Sometimes when Be The Match BioTherapies talks to companies about our managed logistics solution, and specifically my role as a Cell Therapy Supply Chain Case Manager, they aren’t sure it’s something they need. But once they start working with our team, they understand how critical it is.
Our team will manage any issues that come up and we’ll provide a recommended solution. Our clients, clinical sites, manufacturers and Logistics team all know they can call their Cell Therapy Supply Chain Manager at any time. They can talk to someone, pass on information and know it is going to be taken care of.
We’re a voice that can reassure them we’ve gotten the information and we’re going to do our best to fulfill the request.
Our organization has been overcoming supply chain challenges for time-critical cell therapies for more than 30 years, so we have the experience our clients need. This is what we do. We’ve been doing this work for longer than others in the field. Our team is specialized in this one key area and dedicate all our time to it.
Alysia: When you work with Be The Match BioTherapies, you have real people dedicated to getting every shipment where it needs to be. It doesn’t matter if it’s after hours or a holiday. We are sitting at a computer, talking on the phone and figuring it out so these shipments get where they need to be so patients have that second chance at life.
We know how important time is for these therapies. We are always proactively checking on our shipments to make sure they are where they are supposed to be when they are supposed to be there.
If we see a pickup didn’t occur when it was supposed to, we’re on the phone immediately to find out what is happening. We don’t wait until the product misses a flight. We make sure it will be on the scheduled flight. And if not, we immediately start looking for a new option.
Yes, courier services are also dedicated to their mission of getting products where they need to be. But I think it’s different when you have a person on the other end of the phone who is dedicated to Be The Match BioTherapies’ mission of saving lives.
How COVID-19 is changing the production of cell therapies (blog)
When you look back at the last few months as the organization has worked with cell and gene therapy companies to overcome the challenges COVID-19 presents, what are you most proud of?
Alysia: I am so proud of our Logistics team as a whole and our CWT travel team. Everyone is just so dedicated to this mission. Over just the first 37 days of the COVID-19 pandemic, our team worked 2,300 extra hours to make sure all cell therapy patients got the therapy they needed.
Being part of a team that puts our mission of saving lives through cellular therapy as a top priority … it’s very special knowing we all feel that way.
Erin: I’m most proud that we’re able to do it. The COVID-19 pandemic is like nothing any of us have faced before. We’ve stepped up to the plate so we can make sure products get to where they need to go in the requested timeframe. We have been able to do that on every single one of the orders that have come in since COVID-19 started.
When you hear that 80% of domestic flights are canceled and we’re still able to move products … I just think that’s incredible. It shows the importance of the relationships and experience we’ve developed over the years. We’ve been moving mountains for our clients, and most importantly, the patients we all serve.
A reliable supply chain is critical to the successful delivery of cell and gene therapies
Our veteran Cell Therapy Supply Chain Case Managers can support your company by navigating the complexities of cell therapy delivery during the COVID-19 pandemic and beyond. Contact our team to discuss how we can help.