Efficiencies with Personalized Medicine: Just-In-Time Delivery
Over the past two decades, personalized medicine has evolved from a scientific vision to a standard of care for various disease states. With the expanding knowledge in genetics and genomics, precision therapies for cancers and chronic illnesses have advanced. As the shift from one-size-fits-all medicines to personalized treatments based on a person's unique genetic makeup has accelerated, distribution and delivery models are also changing.
For many years, medicine could only be personalized through dosing. Most oral medications sat on pharmacy shelves until needed by patients, with occasional refrigeration required for liquid therapies. Overall distribution followed a hub-and-spoke model supported by traditional pick-and-pack processes.
Complex Molecules Require New Approaches
With precision medicine becoming commonplace, the traditional way of getting therapies into patients' hands no longer suffices. Personalized medicine is primarily formulated for injection or infusion, with complex mechanisms of action, shorter shelf lives, and strict temperature control requirements for maintaining clinical efficacy. These treatments are less likely to be packed in large parcels or pallets.
As distribution centers manage fewer blockbuster shipments and handle more highly individualized and high-value payloads, the adoption of just-in-time (JIT) supply chain practices has proven valuable. JIT principles help reduce waste, including wasted space, inventory, and time. Implementing JIT practices aligns with LEAN methodologies, as historically, up to 40 percent of overall pharmaceutical costs are incurred in the supply chain. However, for personalized medicine, JIT offers additional operational benefits.
Personalized therapies are produced in small batches, shifting focus from high-volume manufacturing to unique, one-of-a-kind concoctions. There is no need for excessive packaging inventory anymore. Entrusting inventory management to trusted partners enables manufacturers and distributors to focus on quality. Smaller physical footprints contribute to greater efficiency and tighter process management, which are crucial for maintaining quality.
Since most personalized therapies require strict temperature control, distribution centers often house commercial-grade refrigerators and freezers. However, with a JIT approach, this expense in terms of power, space, and management can be significantly reduced or eliminated. Experienced Cold Chain as a Service (CCaaS) experts in the pharmaceutical space can pre-condition thermal materials based on personalized therapy handling requirements. This ensures that packaging and shipping materials arrive at the distribution center at the required transit temperature. By removing the responsibility of storage and cooling precision from the distributor, attention can be focused on core competencies. Containers are ready for pack-out as soon as they arrive, minimizing the potential for human error in cooling.
JIT and IoT
Given the temperature sensitivity of personalized therapies, any deviation can result in adverse events for patients. Extreme heat or freezing can compromise the clinical effectiveness of these medications. Hence, there is increasing adoption of IoT technologies that provide real-time visibility into pharmaceutical product conditions. Embedded temperature loggers in packaging track and identify temperature excursions, enabling providers and patients to confirm if therapies remained within a safe temperature range. JIT service also simplifies logger fleet management for therapies packed with such devices, ensuring proper functioning, and positioning within the packaging, and reducing risks and time during the pack-out process.
In addition to temperature monitoring, IoT devices that track location aid in material management. This capability is particularly useful for reusable thermal packaging, automating the replenishment of packaging components. JIT-based inventory management streamlines downstream and upstream supply chain activities. Moreover, this technology-enabled cycle ensures compliance with regulations such as DSCSA, which safeguard the pharmaceutical supply chain against counterfeiting and disruptions.
Data collected from the field can be analyzed retrospectively to inform future supply chain planning decisions. Analyzing aspects like timeliness, condition, errors, patient satisfaction, and temperature excursions can identify failure points and guide remediation approaches. This analysis can highlight the need for carrier, lane, and packaging changes. With JIT approaches, manufacturers are not burdened with shelves of packaging, allowing for more flexible adjustments without concerns about sunk costs or waste.
The personalized medicine market is growing rapidly, and ongoing research suggests that this trend will continue. Responsive and nimble supply chains, coupled with state-of-the-art manufacturing know-how, are critical for safely delivering these breakthrough therapies to patients. By leveraging JIT practices and data capture technologies, pharmaceutical companies can ensure the safe and timely delivery of breakthrough therapies to patients. Let us work together to embrace these advancements and create a more efficient and patient-centric future in personalized medicine.