Kristin Brooks, Managing Editor, Contract Pharma08.29.24
For pharma manufacturers, the growth of GLP-1 drugs to treat conditions such as diabetes and obesity has placed increased strain on the supply chain and subsequent pressure to avoid bottle necks. In response, pharma manufacturers are significantly increasing manufacturing capacity to produce these sensitive drugs—a complex undertaking.
With recent GLP-1 shortages, how are stakeholders ensuring the quality and supply chain security of existing product so what is available can remain viable and accessible to patients? Pharmaceutical supply chain expert, Dan Bell, Senior Vice President of Innovation & Strategic Operations at Marken, discusses the key challenges and considerations for GLP-1s. –KB
Contract Pharma: How are stakeholders ensuring the quality and supply chain security of existing product so what is available remains viable and accessible for patients?
Dan Bell: In the pharma supply chain, we implement numerous strategies to safeguard the quality and security of existing GLP-1 products and ensure their continued availability to patients. As these drugs gain momentum, we know we could see a rapid increase for their demand, given their potential to treat many different indications. This elevates the need for an efficient, reliable cold chain.
The first step is to establish a robust network for storage and distribution in adherence to Good Distribution Practices (GDP) and other regulatory guidelines to maintain product integrity throughout the supply chain. The implementation of around-the-clock temperature monitoring and control systems protects GLP-1 products from degradation. Specialized thermo-isolating packaging materials and handling procedures should be utilized to prevent potential damage, stress and contamination. To maintain stable and viable products, Marken conducts routine quality assessments to identify and address any potential issues before they impact patients.
With solid quality procedures in place, we utilize advanced track and trace technologies to monitor products in transit and leverage extensive network data to forecast demand and identify potential vulnerabilities. This agile approach to supply chain risks has helped us develop flexible solutions to mitigate adverse impacts. Full visibility of the products moving through the network provides stakeholders with real-time data analytics, offering assurance of where these medications are being stored and distributed throughout the supply chain.
Experienced operations teams design detailed business continuity and disaster recovery plans to deal with emergent issues and give partners and patients confidence in our ability to adapt quickly and react to any set of circumstances. To secure GLP-1's in the final mile of delivery, drivers receive specialized training and extra security measures are in place to track vehicles and secure packages while in transit.
Sharing best practices among stakeholders is another strategy to further strengthen the overall supply chain for GLP-1’s and assure patients receive their medications in a timely and secure manner. Collaboration between industry peers and regulatory agencies drives best practices, streamlines processes, and enhances security measures. By maintaining cohesive, collaborative efforts, stakeholders protect the quality and security of GLP-1 products, ensuring their continued efficacy and availability to patients.
Contract Pharma: How can distribution hurdles be overcome to meet demand?
Dan Bell: At Marken, we conquer distribution challenges by elevating cold chain management through advanced technology, decades of field experience and leveraging all potential transportation modes and networks. This ensures shipment security and supply chain agility. Our commitment to innovative packaging solutions is a critical element to help deliver optimal temperature conditions for GLP-1 products throughout their journey. To enhance visibility and product control, Marken integrates real-time monitoring through proprietary software or control towers, providing the best tracking and data analytics to manage product temperature and conditions. These strategies are successful because we integrate a myriad of system redundancies to overcome disruption, thus assuring an uninterrupted cold chain operation.
Continuous review and adaptation of the distribution network is another way to overcome challenges. By utilizing advanced analytics for demand forecasting, we can predict fluctuations and maximize inventory levels. High quality, live metrics are essential in ensuring these plans remain both relevant and the best fit. Employing industry leading route optimization software further optimizes efficiency by minimizing delivery times and reducing transportation costs for GLP-1 products.
Contract Pharma: What cold chain solutions and strategies can be implemented?
Dan Bell: GLP-1 drugs require stringent temperature control, and the best strategy for avoiding risks that impact temperature excursions is to expect disruption. Multiple layers of risk mitigation and contingency plans are vital to ensure product integrity and efficacy throughout the supply chain.
At Marken, we start by utilizing the best performance packaging to maintain stability, whether it be high-performance insulation or incorporating containers with phase change materials to absorb and release heat for stabilizing the desired temperature. This is also a good time to consider sustainable options, as selecting reusable containers and recyclable materials reduce waste and lower costs.
Technology and data analytics offer significant advantages when designing cold chain solutions for GLP-1 medicines. Advanced sensors play a vital role in visibility, particularly when connected to Internet of Things (IoT) technology, offering unparalleled accuracy and responsiveness. Predictive analytics software delivers probabilities to operations teams for identifying potential risks and identifying factors to optimize cold chain performance.
Collaboration is a key strategy for determining best practices, and tools for facilitating cross-organizational communication and information sharing are essential. When considering technology, employing a cloud-based platform for insight sharing and communication offers a centralized system for bolstering uninterrupted service for GLP-1 medicines.
Dedicated cold storage for GLP-1 drugs with precise temperature control and inventory management minimizes product holding times, maximizing the efficacy and quality of these medicines. For storage and distribution, we utilize a world class Quality Management System (QMS) that sends real-time alerts if a deviation occurs, allowing us to act quickly with meticulously tested business continuity plans in place to prevent product impact. These systems are protected with emergency power backup to deliver power if there is an outage. Regular audits and inspections confirm compliance with temperature requirements, local laws and system functionality. These are all mandatory precautions for safeguarding valuable and high-demand clinical products, like GLP-1’s.
Contract Pharma: How can the supply chain be streamlined to mitigate rising costs?
Dan Bell: This is a great question considering the surging popularity of GLP-1 products. There is a lot of debate on how to make these life-changing medicines accessible to patients who need them most, and it's placing significant pressure on healthcare systems.
Streamlining the supply chain undoubtedly helps mitigate expenses for manufacturing and distribution. Accurate demand forecasting optimizes inventory levels, reducing the risk of stockouts or overstocking, thereby eliminating waste and corresponding price increases.
Efficient route planning reduces transportation expenditures and fuel consumption, offering environmental and financial benefits. Improving warehouse layout and storage practices enhances order fulfillment speed and accuracy, further reducing costs. Again, leveraging technology makes a big difference. Data-driven decisions are the lifeline for optimizing supply chain operations, from forecasting to inventory management.
There is also an opportunity to reduce costs through collaboration. Building strong relationships with suppliers can lead to cost reductions through volume discounts and improved terms. Our expertise in evaluating and optimizing logistics helps reduce transportation and warehousing costs. Sharing supply chain data with partners improves collaboration and leads to cost efficiencies.
Of course, mitigating risks is an imperative for reducing costs, which is why we work so hard to eliminate disruption. Loss due to disruption is unacceptable anywhere in the industry, and the disruption over the last several years has led us to create systems capable of handling any challenge, no matter the severity. There is no better solution for delivering the new age of healthcare than a resilient, agile supply chain capable of meeting the on-demand needs of patients, and the exponential growth of GLP-1 drugs over the next several years is sure to test these capabilities.
Dan Bell joined Marken in 2003 and is Senior Vice President, Innovation & Strategic Operations. Dan is a licensed US Customs Broker and a Certified Customs Specialist with 25+ years of experience in the life science logistics and temperature control field. His current focus is regulatory and trade compliance aspects for global life science supply chain solutions. Dan has served as a liaison between his clients, customs and the alphabet soup of regulatory agencies, to ensure the maximum level of compliance with trade laws and regulations. His knowledge and experience in this arena have led to the development of many import strategies that have significantly reduced turnaround times, optimized cost and ensured mission critical objectives have been met or exceeded. As regulatory scrutiny continues to focus on the temperature-controlled supply chain, Dan’s expertise with thermo regulating packaging solutions and temperature logging devices has been critical to meeting the requirements of the recently updated Good Distribution Practices for pharmaceutical transport and similar guidelines.
With recent GLP-1 shortages, how are stakeholders ensuring the quality and supply chain security of existing product so what is available can remain viable and accessible to patients? Pharmaceutical supply chain expert, Dan Bell, Senior Vice President of Innovation & Strategic Operations at Marken, discusses the key challenges and considerations for GLP-1s. –KB
Contract Pharma: How are stakeholders ensuring the quality and supply chain security of existing product so what is available remains viable and accessible for patients?
Dan Bell: In the pharma supply chain, we implement numerous strategies to safeguard the quality and security of existing GLP-1 products and ensure their continued availability to patients. As these drugs gain momentum, we know we could see a rapid increase for their demand, given their potential to treat many different indications. This elevates the need for an efficient, reliable cold chain.
The first step is to establish a robust network for storage and distribution in adherence to Good Distribution Practices (GDP) and other regulatory guidelines to maintain product integrity throughout the supply chain. The implementation of around-the-clock temperature monitoring and control systems protects GLP-1 products from degradation. Specialized thermo-isolating packaging materials and handling procedures should be utilized to prevent potential damage, stress and contamination. To maintain stable and viable products, Marken conducts routine quality assessments to identify and address any potential issues before they impact patients.
With solid quality procedures in place, we utilize advanced track and trace technologies to monitor products in transit and leverage extensive network data to forecast demand and identify potential vulnerabilities. This agile approach to supply chain risks has helped us develop flexible solutions to mitigate adverse impacts. Full visibility of the products moving through the network provides stakeholders with real-time data analytics, offering assurance of where these medications are being stored and distributed throughout the supply chain.
Experienced operations teams design detailed business continuity and disaster recovery plans to deal with emergent issues and give partners and patients confidence in our ability to adapt quickly and react to any set of circumstances. To secure GLP-1's in the final mile of delivery, drivers receive specialized training and extra security measures are in place to track vehicles and secure packages while in transit.
Sharing best practices among stakeholders is another strategy to further strengthen the overall supply chain for GLP-1’s and assure patients receive their medications in a timely and secure manner. Collaboration between industry peers and regulatory agencies drives best practices, streamlines processes, and enhances security measures. By maintaining cohesive, collaborative efforts, stakeholders protect the quality and security of GLP-1 products, ensuring their continued efficacy and availability to patients.
Contract Pharma: How can distribution hurdles be overcome to meet demand?
Dan Bell: At Marken, we conquer distribution challenges by elevating cold chain management through advanced technology, decades of field experience and leveraging all potential transportation modes and networks. This ensures shipment security and supply chain agility. Our commitment to innovative packaging solutions is a critical element to help deliver optimal temperature conditions for GLP-1 products throughout their journey. To enhance visibility and product control, Marken integrates real-time monitoring through proprietary software or control towers, providing the best tracking and data analytics to manage product temperature and conditions. These strategies are successful because we integrate a myriad of system redundancies to overcome disruption, thus assuring an uninterrupted cold chain operation.
Continuous review and adaptation of the distribution network is another way to overcome challenges. By utilizing advanced analytics for demand forecasting, we can predict fluctuations and maximize inventory levels. High quality, live metrics are essential in ensuring these plans remain both relevant and the best fit. Employing industry leading route optimization software further optimizes efficiency by minimizing delivery times and reducing transportation costs for GLP-1 products.
Contract Pharma: What cold chain solutions and strategies can be implemented?
Dan Bell: GLP-1 drugs require stringent temperature control, and the best strategy for avoiding risks that impact temperature excursions is to expect disruption. Multiple layers of risk mitigation and contingency plans are vital to ensure product integrity and efficacy throughout the supply chain.
At Marken, we start by utilizing the best performance packaging to maintain stability, whether it be high-performance insulation or incorporating containers with phase change materials to absorb and release heat for stabilizing the desired temperature. This is also a good time to consider sustainable options, as selecting reusable containers and recyclable materials reduce waste and lower costs.
Technology and data analytics offer significant advantages when designing cold chain solutions for GLP-1 medicines. Advanced sensors play a vital role in visibility, particularly when connected to Internet of Things (IoT) technology, offering unparalleled accuracy and responsiveness. Predictive analytics software delivers probabilities to operations teams for identifying potential risks and identifying factors to optimize cold chain performance.
Collaboration is a key strategy for determining best practices, and tools for facilitating cross-organizational communication and information sharing are essential. When considering technology, employing a cloud-based platform for insight sharing and communication offers a centralized system for bolstering uninterrupted service for GLP-1 medicines.
Dedicated cold storage for GLP-1 drugs with precise temperature control and inventory management minimizes product holding times, maximizing the efficacy and quality of these medicines. For storage and distribution, we utilize a world class Quality Management System (QMS) that sends real-time alerts if a deviation occurs, allowing us to act quickly with meticulously tested business continuity plans in place to prevent product impact. These systems are protected with emergency power backup to deliver power if there is an outage. Regular audits and inspections confirm compliance with temperature requirements, local laws and system functionality. These are all mandatory precautions for safeguarding valuable and high-demand clinical products, like GLP-1’s.
Contract Pharma: How can the supply chain be streamlined to mitigate rising costs?
Dan Bell: This is a great question considering the surging popularity of GLP-1 products. There is a lot of debate on how to make these life-changing medicines accessible to patients who need them most, and it's placing significant pressure on healthcare systems.
Streamlining the supply chain undoubtedly helps mitigate expenses for manufacturing and distribution. Accurate demand forecasting optimizes inventory levels, reducing the risk of stockouts or overstocking, thereby eliminating waste and corresponding price increases.
Efficient route planning reduces transportation expenditures and fuel consumption, offering environmental and financial benefits. Improving warehouse layout and storage practices enhances order fulfillment speed and accuracy, further reducing costs. Again, leveraging technology makes a big difference. Data-driven decisions are the lifeline for optimizing supply chain operations, from forecasting to inventory management.
There is also an opportunity to reduce costs through collaboration. Building strong relationships with suppliers can lead to cost reductions through volume discounts and improved terms. Our expertise in evaluating and optimizing logistics helps reduce transportation and warehousing costs. Sharing supply chain data with partners improves collaboration and leads to cost efficiencies.
Of course, mitigating risks is an imperative for reducing costs, which is why we work so hard to eliminate disruption. Loss due to disruption is unacceptable anywhere in the industry, and the disruption over the last several years has led us to create systems capable of handling any challenge, no matter the severity. There is no better solution for delivering the new age of healthcare than a resilient, agile supply chain capable of meeting the on-demand needs of patients, and the exponential growth of GLP-1 drugs over the next several years is sure to test these capabilities.
