For innovators developing cell and gene therapies, there is a natural flow from clinical trial logistics to commercial logistics. Proactive planning – particularly during the early stages – is vital to establish scalable processes to support patient, provider and payer requirements and enable a product’s commercial success.
Many manufacturers need support to handle the logistics that cell and gene therapies require, whether that be sourcing material from patients, maintaining proper temperature controls, or distributing the products widely enough for patient impact.
Although the specifics of each treatment may vary, all have one thing in common. Each therapy is composed of living cells or viral vectors with an extremely limited lifespan. It is absolutely crucial and critical that the therapies are transported on time and in pristine condition, both to and from the manufacturer, and ultimately to the treatment site for patient administration.
The supply chain examined
The dependencies between each touchpoint in cell and gene therapy are far greater than in traditional specialty pharmaceutical production—and the coordination needed to manage them effectively demands true connectivity.
People are part of the cell and gene therapy supply chain. For autologous therapies, the patient is at the start and end of a circular pathway. Along this non-traditional therapeutic journey, harvested patient cells and tissues exit and re-enter traditional supply chain boundaries in a biologically altered state. Meanwhile, a few healthy donors can provide the starting material for hundreds of allogeneic therapy doses. For gene therapy, new genetic material is introduced into the patient’s DNA. In all cases, this means the supply chain needs to be cGMP-compliant with chain of custody tracking and overall orchestration.
Detailed knowledge of the complete supply cycle is necessary to develop therapy-specific risk assessments, and these risk assessments should then be used to design the logistics strategy for these products; patient-specific therapies require therapy-specific supply chains.
From clinical manufacturing to commercial success
It’s a significant step to go from the clinical trial setting to a fully commercialized product, but there will be no distinct hand-off from the clinical to commercial supply chain. Manufacturing and logistics must scale up and scale out to serve an increasing number of patients while additional stakeholders join the supply chain. The commercial supply chain is the clinical supply chain—only further reaching with added complexity. This complexity is caused by the barriers patients will face relative to access and affordability, as well as the high degree of interdependencies between the specific steps required.
As the product moves into full commercialization, the existing visibility in the supply chain will transform into the need for visibility of the entire patient journey, including enrollment and access, as well as logistics events to trigger order-to-cash processes and payment collection.
Aligning the growing number of stakeholders is a challenge, and one that must be proactively engaged. Cell and gene therapy owners should consider the following:
- Make clinical decisions early on that have the capacity to scale up and out as the product moves to market
- Focus on the logistics—from time and temperature-shipping requirements to the financial processes required to support the commercial launch
- Select a partner who can support the growing complexity—from increased production volumes to geographical reach and the creation of patient programs
- Create joined-up, integrated processes that prioritize the patient in the supply chain
- Integrate data to support multiple outcomes—needle-to-needle tracking, chain of custody evidence, proof points for regulatory approval—to inform patient care and experience improvement, ultimately enabling effective communication between all stakeholders
As cell and gene therapies move through clinical trials and advance toward a commercial launch, innovators must overcome unprecedented challenges. In many cases, this will require redefining established approaches within many areas of commercialization, including the supply chain.
World Courier, along with AmerisourceBergen’s portfolio of other market-leading companies, create interconnectivity at each touchpoint – from supply and blood draw through to the delivery, patient infusion and, ultimately, billing – for cell and gene therapy innovators. This provides manufacturers the “needle-to-needle” visibility required to meet provider, patient and payer needs while driving cell and gene therapy success.
Download the digital experience Commercializing Cell and Gene Therapies for actionable insights for those ready to shape this new landscape. Authored by AmerisourceBergen’s multi disciplinary and market-leading experts, readers will learn what it takes to design an effective commercialization strategy and execute an integrated solution when the patient is in the supply chain.