Evolving Business Models to Meet the Future of Healthcare

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Enabling a vein-to-vein supply chain for cell and gene therapiesYourway provides integrated supply-chain solutions for the global pharmaceutical and biotechnology industries. We exceed traditional offerings to provide customized support that includes warehousing and packaging, project management, planning and optimization guidance, comparator sourcing, ancillary-supply sourcing, forecasting, and returns/reconciliation management. Our single–specialized-provider approach offers clients a high level of convenience and efficiency that translates into quality, speed, and operational improvements.

A Growing Global Footprint
As we introduce new added-value solutions, expand our global footprint, and continue investing in infrastructure, technology, training, and innovation, our goal is to solidify our position as the biopharmaceutical industry’s provider of choice. We currently operate in 21 good manufacturing practice (GMP) depots strategically positioned around the world. That network gives us access to many countries through a wide range of transportation methods.

Our depots have acted as a lifeline during the COVID-19 crisis. Although Yourway is witnessing the pandemic’s negative impact on clinical trials for biologics and cell and gene therapies (CGTs), we have experienced an uptick in business and have continued operations without interruption. We have augmented existing GMP and good documentation practice (GDP) cleaning requirements and have been vigilant in monitoring the COVID crisis.

Direct-to-Patient Services
To keep clinical trials running smoothly despite stay-at-home recommendations and large-scale closures, we have bolstered our direct-to-patient (DTP) and direct-from-patient (DFP) services for decentralized/virtual trials. We understand that a majority of decentralized/virtual trials require in-home care services — even during pandemics. To anticipate potential hurdles, we design logistical solutions based on the needs of patients, sponsors, and healthcare professionals alike. Yourway prioritizes patients while offering regulatory compliance, cost-efficiency, and operational excellence through our virtual-trial offerings.

Even though a shift toward DTP trials increases supply-chain complexity, we have the experience necessary to carry out decentralized trials worldwide with positive results. DTP/DFP trials require the coordination of various systems and stakeholders to reach patients at the right time and at their preferred locations. Although complex, this new model promotes patient compliance and retention by providing materials and proper care safely and conveniently.

Vein-to-Vein Supply Chain
The CGT industry is inherently patient-centered, with patients representing a critical part of the supply chain. Patients receiving autologous therapies donate their own cells. In return, they receive a living treatment, creating a vein-to-vein supply chain. Such a process requires platforms that connect a therapy with a patient. Doing so not only would increase traceability and facilitate outcomes monitoring, but also would ensure that no errors are made during storage, transportation, preparation, and finally administration.

Temperature control is a vital concern for CGT shipment and distribution. These therapies have a narrow window of viability and require immediate shipment to preserve their efficacy. This factor puts additional pressure on logistics providers. Supply-chain companies that possess large networks and access to many depots are at an obvious advantage.

The shorter the shelf life of a therapy, the more intense its logistical challenges. This is especially true on an international level, at which customs issues and specialized regulatory requirements come into play. As more CGTs pass the approval phase, there is a risk that the amount of infrastructure needed to handle them will not be in place, which would create significant bottlenecks and put patients — and therapies — at risk. Considering the medical importance and high costs of CGTs, nondelivery or spoiled delivery would have detrimental consequences.

Cryogenic Materials: CGTs typically are stored at temperatures below
–60 °C (to –150 °C). Such conditions ensure optimal cell counts and help cells retain their potency. Designated shipping containers that support cryogenic temperatures must be used to protect CGTs. Two common container types include dry-ice and dry–nitrogen-vapor shippers.

CGTs require real-time temperature monitoring to ensure drug-product quality after deployment. Thus, temperature-monitoring tracking devices should be embedded within containers and programmed to send alerts when intervention is needed (e.g., when dry ice needs refilling or liquid nitrogen needs recharging) and when shipments reach landmarks along their journeys. Shipments must be packed durably so that therapies remain unaffected by extreme physical conditions. Improper packaging or labeling of a shipment could result in delivery errors and compromised samples. Quality control is also essential in supply-chain logistics. Shipments must be cross-checked comprehensively to ensure against leaks and other issues, which could subject the sender to an audit by the US Food and Drug Administration (FDA) and/or other regulatory agencies.

Shipping Expertise: Yourway emphasizes due diligence to ensure that shipments comply with regulatory guidance. We are experts in temperature-controlled logistics, having invested in state-of-the-art tools that are needed to keep up with rapid breakthroughs in medicine. We are dedicated to preventing bottlenecks in the biopharmaceutical industry. Through our global network, we are able to manage international shipments effectively and efficiently.

Yourway employs experienced logistics providers who solve supply-chain challenges routinely. We understand intimately what is required for advanced therapies to ship out successfully, with expertise in all aspects of temperature sensitivity and the temperature-controlled chain. Top-of-the-line technology ensures that all shipments are delivered on time and according to specifications. We can guarantee speedy delivery because we customize our transportation solutions to fit each client’s needs.

We take advantage of preclearance capabilities at customs agencies worldwide so that time-sensitive shipments are not delayed at international borders. Deliveries are expedited proactively so that our agents can bring shipments to their destinations without issue. We have no size or weight restrictions, so customers can rely on us regardless of what is being shipped out and where. Partnering with Yourway can shorten turnaround times and ensure that cell, gene, and other advanced therapies reach patients as soon as they are supposed to, wherever patients are.

“Virtual Pharma” Advantages
Virtual pharmaceutical companies (VPCs) increasingly seek to develop and commercialize CGTs. By definition, such companies lack the internal resources and structural capacity needed to advance candidate therapies into clinical trials. However, VPCs can be more flexible than traditional pharmaceutical companies in resource allocation and leadership, which is leaner and arguably more efficient than in big companies because it lacks extensive bureaucracy. Instead of being limited to in-house equipment, VPCs can seek out resources based on needed capacity and efficiency. That flexibility also extends to customer costs because VPCs have low overhead costs as opposed to high fixed costs.

Because VPCs are structured so differently from big pharmaceutical companies, their needs are distinct. With flexibility built into our organization, Yourway is an ideal partner for small and VPCs that need to leverage external resources to advance their CGT products. We emphasize the personal aspect of logistics — because no two projects are the same — and provide fully customized support. This level of customizability is ideal for VPCs that have little “bandwidth” to waste worrying about the status of a shipment. At Yourway, quality is ingrained in our organization, and that is something our customers can count on. We have capacity to transport highly sensitive materials and ensure that temperatures and other vital specifications are maintained en route to every destination.

Improving Clinical Outcomes
Our clients understand the importance of having one service provider and a single project manager assigned to coordinate planning and execution of services. The Yourway team is aligned in our commitment to bettering the lives of patients. Because of that, we embrace every project and give it the utmost dedication regardless of size and scope. Our on-call, 24/7 customer support team is driven by the fact that our company’s collaborative efforts help improve the quality of life of clinical trial participants — and the possibility that many other patients could benefit once a therapy is approved for commercial use.

Gulam Jaffer is president of Yourway, 6681 Snowdrift Road, Allentown, PA 18106; jaffer@yourwaytransport.com; 1-610-395-9198.

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