Ray Hornung, head of logistics for Be The Match BioTherapies (BTMB), spoke to us about just that, and the adjustments the service provider to the cell and gene therapy (CGT) sector has implemented since February 2020.
What does the company do?
BTMB, which was founded in 2016, is an extension of bone marrow transplant facilitator, Be The Match; it looks to partner with global CGT industry leaders to deliver high-quality, consistent and compliant autologous and allogeneic cellular therapies to patients in need.
Today, it works with more than 40 cell and gene therapy companies ranging from small, start-ups to large pharmaceutical companies including Gamida Cell, AgenTus Therapeutics, Kiadis Pharma, Poseida Therapeutics, Celyad, Tmunity, Magenta Therapeutics, and NantKwest.
“We are really one of a few global organizations offering full end to end solutions for cell and gene therapies. We established BTMB to help CGT companies bring emerging therapies to patients sooner,” said Hornung.
BTMB, he said, has developed cell sourcing expertise and a predictive search algorithm for customized donor selection. And it has also developed the relationships and expertise to navigate cell therapy supply chain complexities, coordinate logistics and deliver time-critical therapies on time.
“We have capabilities that start all the way at the beginning – cell harvest, a network of cell collection centers, the collection of cellular starter materials, while for manufacturing, we maintain a chain of custody, a chain of identity and we also track outcomes, gathering the data to determine what is going well and what is not.
“If a client is looking for pre-clinical trial support, or their clinical trial is underway, or they already have a commercial therapy, our services can help them manage that better.”
COVID-19 induced actions
Hornung said BTMB’s general service level agreement for fresh starter material delivery is under 48 hours and that the company has been maintaining that time, despite the changes in transportation systems since the start of the COVID-19 pandemic.
“Since February last year, there has only been 32% of commercial passenger airline capacity available. Half of CGT related cargo goes on passenger aircraft, so that could mean a significant reduction in our ability to move products. We have had to diversify our transportation systems even more, as a result. We are using a hub and spoke system in Europe, and we have negotiated with various governments in Europe to allow our couriers entry despite a ban on US citizens coming into their countries.”
How challenging was that to achieve?
“It goes back to the relationships we have developed. For instance, we are the only program to receive a blanket authorization from the US Center for Disease Control and Prevention (CDC) to allow foreign national couriers to come into the US after the travel ban was put in place in March 2020.
“We also negotiated with customs and border control [officials] to bring products back from Canada.
“And we leveraged the relationships we have with our partners with the US government to influence our foreign national friends, so we have been dealing with the French embassy, the Dutch embassy and the UK authorities. Despite the blow up in the new UK over the new COVID-19 strain, we have only been able to strengthen our resolve to get product in and out of the UK. We go back and forth negotiating with government, regulators, and also getting our partner registries in various countries to advocate on our behalf so we can get those permissions put in place.”
BTMB has also been working with labs in the US to try and speed up COVID-19 testing so it can determine that donors, when required, are negative for the virus. It has been focusing, in that respect, on its staff and couriers as well.
Hornung’s background in US army operational logistics, as well as its training in emergency management and continuity business planning, supports him in this role. “If I have to deliver a therapy to a patient that is in Charleston, South Carolina, and there is a hurricane that is coming to that day to Charleston, and all 14 lanes of the highway are pointed away from the coast but I have a product that needs to be delivered to the coast, I have to know who to call. My training in the military and my training thereafter gives us the tools to effectively manage logistics. So I know who to contact at the South Carolina state emergency operations center to be able to get a pass for a driver and a courier to go on an alternate route towards the coast and what documents they would need to get through the police checkpoints so we can still deliver for that patient.”
The onset of the COVID-19 pandemic last year also saw the company move to shorten the distances that donors need to go to get collected during the pandemic.
“We have heat maps so we know where the hot zones are in the US; we focus our collections on apheresis centers located outside of those hot zones. By having that very diffused network of collection centers, we can ease the concern of donors about where they go, and we can also shorten the distance that donors may have to travel.
“We also engaged with a variety of volunteer pilot organizations, private aircraft in the US, to be able to move donors to collection sites that they might not have been able to get to.”
Some of BTMB’S clients pushed backed their studies due to COVID-19. “The manufacturers, however, were, and are still willing to manufacture and so we are still willing to deliver.”
The company move products at all temperatures, from cryopreserved to standard refrigeration ranges.
From packaging the product, to ensuring the right supporting documentation, to getting it on the passenger or cargo aircraft and landed at the closest airport possible to the end destination, it is very much a “white glove service” the company looks to provide.
“And that approach gives us a lot of visibility. There is a sense of certainty. It is not just on the way. It is on specific flight that we are monitoring or it is be rerouted. We have had to do that where there has been adverse weather or, more recently, when the air traffic control tower at Atlanta airport, for example, got shut down due to a positive COVID-19 case
“Because we know where these products are at any time in transit, we can redirect them.”
The company has a proprietary system it uses to track packages. “The electronic data interfaces of our providers [couriers] are integrated with our situational awareness software, and that system tells us where the problems are; the system gives us options, we can identify excursions early and manage them preemptively. That allows us to better manage logistics.”
Despite the pandemic, he said the company has not encountered a break in its ability to deliver to patients.
“Last year, overall, we delivered 6,660 products for patients. We maintain a core of over 300 couriers that are moving products every single day in 40 different countries to make sure patients are getting the therapies they need based on whatever their clinical indication is or whatever studies they are enrolled in.”
In terms of next steps for BTMB as the COVID-19 pandemic continues, Hornung said the idea is to focus on sustaining or improving on the company’s delivery pathways using the widest variety of qualified partners, to make sure clients get the product when they want it, where they want it and in the condition they expect.
“We also anticipate increased regulatory guidance to come out this year around CGT that we are going to have to respond to.”
In addition, it will continue to work with labs to ensure timeliness of COVID-19 testing.
And it has extended its service offer. BTMB announced a partnership with Lonza back in November regarding manufacturing, whereby Lonza would be the preferred partner for CDMO services for BTMB’s clients.
The goal of the collaboration is to improve efficiency across the CGT supply chain, inclusive of apheresis network management, healthy donor tissue supply, manufacturing and, where appropriate, supply chain management and logistics.
“We have clients that come to us asking what manufacturer they should use.
“Lonza is very well respected in the industry.
“What we are doing now is going beyond cell sourcing, we are going all the way through the process, to manufacturing – it makes that single provider line even longer.”