5 Not-So-Obvious Challenges Facing the Cell and Gene Therapy Supply Chain
The term “supply chain” is misleading. It conjures images of a solid, unbreakable system of delivery, forged by steel perhaps, whose links are strong yet flexible. The metaphor is even more misleading when you consider the unpredictability of delivering patient therapies. The portage of fragile, often unstable bundles of medicine and technology across the world and into the hands of people whose very lives depend on their timely delivery: What could go wrong?
By studying CGT logistics, we take a closer look at the supply chain, examining the obvious breaking points and anticipating weaknesses and potential disruptions. Following are three obvious points of weakness, and two more you may not have considered.
1. Not enough logistics providers for future manufacturing.
Sometimes, the difficulties start at square one. CGT manufacturing capacity across the country is not as robust as we hope it will eventually become, and there are not enough Qualified & Specialty logistics providers in the market to handle the increase in manufacturing anticipated for the near future. With millions of square feet in buildings currently being constructed to support CGT manufacturing, the demand on logistics companies capable of supporting transport of those therapies — already spread thin — will be increased dramatically.
2. Shortage of trained drivers.
CGT delivery drivers must have specialized training in the fundamental aspects of CGT logistics that cannot be overlooked, such as temperature control and extremely tight time requirements. This kind of training poses an additional resource expense in which many logistics companies decide simply not to invest. Adding to the challenge, there is a current driver shortage. The American Journal of Transportation reported in August that the U.S. requires around 80,000 additional drivers to make up the shortfall.
3. The need for highly individualized transportation.
The variables for every single CGT route are overwhelming: Temperature control of the package. A defined chain of identity/custody. Preconditioning of packaging. The unpredictability of commercial airlines. And, as always, the ticking clock. Most importantly to both the CGT supply chain and to those of us who specialize in CGT treatments, each supply chain must be dedicated to each patient for their treatment and cannot be used for a wide variety of deliveries.
4. NEW: Reduced in-office care.
Patients aren’t just receiving their care or treatments in the doctor’s office anymore; they’re engaging with their physicians virtually and getting their treatments remotely. This will only increase as our culture becomes more accustomed to receiving remote medical care. That means an even wider area of deliveries and more stops along every route, with some deliveries made right to patients’ doors. We see that direct-to-patient CGT as the dominant trend for future clinical trials and therapeutics.
5. NEW: There will only be more and more CGT demand.
At the same time CGT manufacturing is not yet meeting demand, the recent past has been characterized with consistent new builds currently under development. There are only around five companies in the U.S. with the ability and expertise to handle the complexity of this logistical work, and all of them will be stretched to the limit if other companies don’t increase their CGT logistics capabilities.
Our mission has led to solutions
Our mission, to make the greatest impact on human life, has led us to develop capacity and experience in the CGT field that many other logistics companies cannot match.
Some solutions are practical: Our drivers participate in extensive CGT training so that each one can rise to any difficulty that presents itself along the route. We employ more than 1,500 white glove-trained drivers who serve as an irreplaceable and integral part of our company, and whose consistency helps build familiarity, dependability, and trust with our clients. Our drivers co-track the chain of identity (COI) and the chain of custody (COC) in real time both before the delivery and during each route as part of the white glove service, with both corresponding data streams available to all parties. Our quality and compliance department is dedicated to building out SOPs, as well as 24/7 CGT monitoring. That means we can send real-time data direct to customers, including updated ETAs, delivery details and more. Most importantly, our extensive experience and expertise allows us to make changes, when necessary, literally on the fly.
Our dependability translates to on-time delivery, with Associated Couriers boasting a 98% or above on-time rate. While commercial airlines create unpredictability, and these deliveries cannot be commingled with others on any FedEx or UPS route, our extensive network of drivers ensures that every CGT delivery is on time, every time. While other companies cannot devote an entire day or even multiple days to one delivery, we can dedicate drivers to single shipments. This ensures exclusive use of the vehicle, with no contamination from any ride-along goods. With to-the-minute COI and COC tracking, we can always accommodate updated final mile deliveries, assisted by our wide-ranging hub network that can support a variety of cold chain needs around the United States. We’re also at the forefront of global CGT logistics, handling every step of each shipment including customs, flight booking, package conditioning, packing, repacking, and tracking, both domestic and international.
Our expansive driver network also makes it possible for deliveries to be made to facilities or direct-to-patient. To date, we have expanded to direct-to-patient deliveries for five major CGT drug developers. And our deep roots in the radiopharmaceutical world — including more than 45 years of oncology expertise — are irrevocably intertwined with our company’s culture and will always be centered around dependable service for positive patient outcomes.
By living our motto of “Logistics for Life,” we strive to ensure that every CGT delivery gets where it needs to be when it needs to be there — because we know that every CGT treatment can mean the difference between life and death. By facing present challenges with care and preparing for future obstacles now, Associated Couriers is forging an even stronger chain.