Travel disruptions caused by COVID-19 have meant little more than delayed holidays or missed work meetings for most of us. They’re inconveniences, but hardly life-threatening challenges. But for patients who depend on cell therapies to provide potentially curative treatments, the pandemic’s canceled flights and closed borders have posed a real threat to their wellbeing.
In response to the coronavirus, logistics managers for cell and gene therapy supply chains have been strengthening their donor sourcing and product delivery strategies. These strategies also help mitigate risk as cell and gene therapies move from clinical trials to commercialization.
We explored these strategies during a recent webinar with expert panelists including:
- Ray Hornung, MBA, MBCI, CEM, CBCP, Senior Manager, Logistics and Emergency Preparedness, Be The Match BioTherapies® and the National Marrow Donor Program®/Be The Match®
- Amit Agarwal, Managing Director, Life Sciences, Deloitte Consulting
- Chris Learn, PhD, Senior Director, Therapeutic Science and Strategy Unit, IQVIA
Hornung discussed the challenges inherent in growing donor pools and cell therapy supply chains. Even in normal times, he said, business risk increases as operations grow.
“It’s easy to manage a trial when there’s 10 patients registered. It’s not going to be that easy when there’s 1,000,” Hornung noted. “Every new patient introduces multiple points for potential error in the delivery plan.”
Size matters: Ensuring donor pool sustainability and cell therapy supply chain success when scaling up and out
Compensating for intensified logistical complexity during COVID-19
The COVID-19 pandemic has magnified the logistical complexity of allogeneic and autologous cell therapy supply chains. For example, when donors are unwilling or unable to travel, supply chains are disrupted at the source. To compensate, Hornung suggested a number of changes in operations, such as:
- Onboarding new apheresis collection centers in strategic locations
- Directly managing center schedules to increase efficiencies
- Building redundancies into shipping itineraries
Hornung also emphasized that strong partnerships with corporate and government entities are essential to keeping supply chains moving.
Partnerships were a recurring theme in the hour-long discussion. Scaling up is all about managing risk, and having strong partners to rely on can help keep risk to a minimum. This is true whether sourcing donor material from a diverse collection network or hand-delivering fresh cell therapy products by private jet.
Cell therapy supply chains “are like an orchestra,” Hornung said. “There’s a lot of opportunity for variability when we’re dealing with human beings … and that variability can happen at any point in the supply chain.”
Using the lessons learned by other cell therapy developers
For Agarwal, one of the most important considerations for cell therapy developers is factoring taxes into the supply-chain equation. It’s something he said his clients learned to do the hard way.
“We had one of our clients who is doing their manufacturing in the [European Union] that has had to really think about where the donor material comes from,” Agarwal said. “As it gets routed through their manufacturing setup in Italy, what are those [tax] implications? That is something that can be a real surprise if you don’t think about it ahead of time.”
Dr. Learn, meanwhile, said companies looking to expand should examine the experiences of trailblazers who came before them. “If you look at … how Novartis [scaled up],” for example, “it was a very bespoke and localized production to ensure timeliness and quality of receipt.”
But it takes a lot of money to build that type of system. For smaller firms that cannot replicate the Novartis model, following established standardized practices becomes essential, Dr. Learn said.
Managing the transition to a commercial environment during a global pandemic
Of course, no previous cell therapy developer has had to manage through the impact of a global pandemic. For therapy developers navigating the transition during COVID-19, every aspect of the supply chain — from donor willingness to the availability of manufacturing slots — must be reevaluated, the panelists said.
Consider, for example, how infusions are now administered. According to Agarwal, most recent products coming to market are designed to be infused on an outpatient basis. But this has been affected by the availability of ICU beds.
Outpatient clients themselves might not need an ICU bed at the time of infusion. However, the risk of complications requires that a bed be reserved just in case. That is a contingency the COVID-19 pandemic has complicated.
“Now, if you’re trying to do it in a place in Florida or Texas,” states with high levels of COVID-19 at the time of the webinar, Agarwal said, “getting an ICU bed reserved can be a real problem.”
Taken together, the obstacles to scaling are significant. But with smart logistical planning and strong corporate and government partnerships, the chances for long-term success increase exponentially.
“If everybody’s paying for the highest level of service, then nobody’s really getting it,” said Hornung. “When stuff gets stuck, wherever it gets stuck,” you need a partner who “knows who to call to help get it moving.”
Interested in hearing more? Access the on-demand webinar, Size matters: Ensuring donor pool sustainability and cell therapy supply chain success when scaling up and out.
Other resources that may interest you
Navigating a time-sensitive cell therapy supply chain during the coronavirus outbreak (blog)
How starting material quality impacts the manufacturing and success of next-generation therapies (webinar)
Scaling up and out: Developing a commercial supply chain strategy to successfully deliver next-generation therapies (webinar)
5 Qualities to Seek in Your Cell Therapy Supply Chain Vendor (blog)