As the largest distributor of specialty products – and a leading partner in the commercialization of orphan drugs – AmerisourceBergen has become a leader in the health care industry. With the advances set forth by the Human Genome Project and the remarkable innovation of manufacturers, a new class of drugs are transforming the continuum of care. With highly complex and patient-centric structures, cell and gene therapies have challenged the traditional processes of specialty therapies. World Courier, the global logistics arm of AmerisourceBergen, is a partner on the front lines of cell and gene therapy, creating efficiencies through every intricate phase of product transport, storage and logistics management. Sam Herbert, President of World Courier, shared his perspective on the evolution of cell and gene therapies and how their unique attributes are influencing changes to the traditional supply chain and introducing new questions manufacturers must consider as they build commercialization models.
What challenges do cell and gene therapies present for manufacturers?
The novelty and unpredictability of cell and gene therapies, coupled with initially small patient populations and the potential for a single-dose treatment model, set intrinsic hurdles for manufacturers. Because the patient’s own body is part of the product—and therefore part of the manufacturing and supply chain processes—cell and gene therapy manufacturers face complexities that are orders of magnitude greater than many other specialty and orphan products. For patients with acute conditions, a manufacturer’s ability to successfully address these complexities could have life or death consequences.
Let’s look at the supply chain specifically. Whether it’s during a clinical trial or following a product’s commercial launch, there’s no margin for error in the time-sensitive and temperature-controlled transport and storage of cell and gene therapies. The personalized nature of each therapy means there’s generally no back-up product to ship. A mistake in the supply chain means the manufacturing process must begin all over again, which would cost crucial time for the patient.
The innovation of each cell and gene therapy also creates unique supply chain models and many of these models vary with unique requirements. For cell therapies, beginning with working with sites of care to collect live cells from patients all the way through the transport and manufacturing processes and ending with patient infusion, each therapy requires its own, customized logistics and manufacturing workflows, packaging and transport requirements, as well as controls to measure and ensure quality.
The challenges in supply chain then magnify across all other interdependencies of product commercialization—from regu-latory compliance to reimbursement to provider education to patient support.
What services are available to support cell and gene therapy manufacturers?
Because the complexity of this therapeutic category is so immense, the services to support each product must be extremely customizable, inherently high-touch and tightly integrated.
Each therapy is comprised of living cells with a limited lifespan. Thus, world-class logistics is of immense value to manufacturers and – at a global scale – that involves many moving parts. World Courier’s services span the fulfillment of kitting at apheresis site, coordination and tracking of samples, temperature monitoring, notification of interruptions or changes and chain of custody tracking. Our leading-edge product data monitoring and real-time temperature tracking ensures products remain fresh. In addition, we provide advanced cryopreservation and cryoshipping technologies that add an element of flexibility in the supply chain. Our contingency planning makes us capable of resolving a variety of unexpected situations. These logistical services are tailored to perfectly sync with the apheresis center, provider, manufacturer and patient for each cell and gene therapy.
We also have the added benefit of partnering with AmerisourceBergen’s best-in-class commercialization services. Xcenda, AmerisourceBergen’s strategic consultancy, provides internationally recognized health economics and market access expertise with services that include trial design, payer strategy, reimbursement and coding analysis, and real-word evidence generation to support longitudinal data collection and bolster the product’s clinical and economic value proposition. Lash Group, also a part of AmerisourceBergen, designs and develops high-touch, high-tech hub services so patients have the support necessary to start therapy quickly and progress through the treatment cycle efficiently. An effective hub model will be a critical tool for these high-costs therapies. From ensuring patients overcome the access barriers that correspond with payers’ high utilization management, to facilitating consistent patient education, reliable scheduling, and data collection; the hub will coordinate services and be a source of insights across every stage of the patient’s journey.
Even breakthrough clinical therapies will require a solid market access strategy and tailored patient services program to ensure payer coverage, provider uptake, a seamless patient experience and the data necessary for manufacturers to continue to improve product performance.
How does the complexity of these products change the needs of manufacturers?
To achieve the best clinical outcomes, the biological samples in development must be flanked with the support of a partner with broad expertise, global reach and flawless supply chain execution.
Manufacturers need strict temperature ranges and qualification of transportation systems. They need to meet extremely tight turnaround timelines – typically 18 to 36 hours. Collections and deliveries must be facilitated 24/7. And, cross border shipment and unique travel challenges, such as inability to x-ray, must be navigated swiftly.
We have early and open dialogue with many manufacturers, discussing what the role of a full-fledged logistics solution is and the best practices needed to support the success of these products. As these products move through development and approach commercialization, those questions will shift to become about scale and taking the processes in place from clinical trials and scaling up and out when the product goes to market. Even if the patient population isn’t getting much bigger, the variability of where and how a patient presents becomes an important factor.
What do the next few years hold for cell and gene therapy manufacturers and patients?
Cell and gene therapy is at the front lines of personalized medicine efforts with billions of dollars in investment from manufacturers and a projected market size of over $50 billion by 2025. The future is bright for enhanced patient outcomes, and the stakes are high for manufacturers.
At World Courier, we’re looking ahead to ensure both treatments and their diagnostic testing counterparts are shipped appropriately and maintain integrity throughout the supply chain. We’re laying the groundwork now for a natural flow from clinical trial logistics to commercial logistics and preparing to surmount the additional challenges to come as these products bridge into the market. For example, in treatment, a therapy is generally not stocked or shipped by distributor, but in the commercial setting, invoices must be sent and collected upon; financial risk must be mitigated; data collection and analysis must occur.
Beyond supply chain logistics, patient care will require intensive scheduling and coordination, a more complex patient-centered supply chain will need sophisticated data aggregation, high price points will invite more payer restrictions, and the reimbursement model will be redefined to fit one-time therapies that potentially offer curative treatment. The current model for specialty and orphan therapies will evolve to suit the unique needs of cell and gene therapies and the distinct journeys these patients will take. We have an opportunity to partner with cell and gene innovators to create an ecosystem designed around the needs of the patients and providers, one that maximizes access to these most innovative treatments and creates transparency for the manufacturer to manage the patient and physician experience. That’s why it’s essential for manufacturers to prepare now for the future and work with partners who can provide integrated infrastructure and operation models that will scale to foster their products’ growth.
To learn more, about AmerisourceBergen’s work in the Cell and Gene Therapy space, see World Courier’s eBook athttp://bit.ly/2lR1SdO