SUPPLY CHAIN SOLUTIONS - From Lab to Life: Strategies for Unwavering Resilience in the Clinical Supply Chain

INTRODUCTION

In today’s complex and interconnected environment, the im­portance of a reliable supply chain has never been greater. Spe­cialty supply chain companies are expanding healthcare’s reach globally by investing in strategies that enhance supply chain re­siliency, thereby delivering essential services where they are needed most.

As new innovative medical technologies and time-sensitive therapies continuously emerge, the effectiveness of logistics, stor­age, and distribution solutions are pivotal in disease prevention, treatment, and management. Recent years have tested the re­silience of the pharmaceutical supply chain, highlighting its es­sential role in ensuring seamless drug delivery from manufacturer to patient. Despite disruptions, these supply chains have shown remarkable adaptability, innovating to enhance the transport of critical shipments and advanced therapies. Such challenges un­derscore the need for specialty logistics teams to build a flexible, anti-fragile supply chain capable of withstanding global uncer­tainties. The role of knowledgeable supply chain experts has never been more significant to ensure the uninterrupted flow of essential medicines worldwide.

CONTINGENCY PLANNING: ENHANCING SUPPLY CHAIN RESILIENCE WITH OPTIMIZED REGIONALIZATION STRATEGIES

Regionalization strategies are key in accelerating and safe­guarding supply chain integrity. By diversifying production and procurement across various suppliers and geographical regions, supply chains become more robust, capable of overcoming chal­lenges such as climate disasters, geopolitical instability, labor shortages, and regional resource scarcity. This contingency fore­casting approach ensures if one facility or shipping lane faces disruption, alternative nodes in the network maintain the essential flow of medicines. Lessons from the pandemic have reinforced the value of geographically dispersed manufacturing and distri­bution networks, creating redundancy while managing risk to en­hance supply chain flexibility.

Diversifying supply chain resources is crucial in forging re­silience. It reduces over-reliance on single sources and eases pressure on specific regions, thereby mitigating the impact of lo­calized disruptions. The regionalization of resources and manu­facturing, a growing trend in recent years, continues to be instrumental in addressing global challenges. For instance, con­sider how the European Union’s decision to phase out Russian fossil fuels impacted the availability of dry ice, essential for cold chain packaging.¹ This challenge prompted supply chains to in­novate, expanding their supplier network and adopting self-man­ufacturing methods. Moreover, diversifying suppliers and exploring alternative transport routes has proven effective in distributing medications to hard-to-reach areas, as seen during the Ukraine conflict and the pandemic.

Another strategy is proactively streamlining regional regu­latory processes to maximize supply chain agility. Marken’s global trade compliance team ensures compliance with all regulatory requirements, local laws, and custom guidelines. Our Qualified Persons (QPs), pharmacists, and technical directors with diverse expertise in product types and dosage forms across all four regions (NORAM, EMEA, LATAM, APAC) are personally dedicated to ensuring the qual­ity of investigational medicinal products (IMPs) being released aligns with the spe­cific clinical protocol. Through meticulously executed global supply chain audits, our QPs and pharmacists mitigate risk and confirm that only compliant products are released in support of QP declarations for import into the EU and their own regions respectively.

COLLABORATIVE COMMUNICATION DRIVES SYNERGISTIC SUCCESS IN SUPPLY CHAIN ORCHESTRATION

Another major consideration for building resiliency in the supply chain is end-to-end collaboration, extending be­yond healthcare and pharma organiza­tions to include suppliers as well. This approach fosters proactive insight sharing and joint contingency planning, enabling a unified response as situations evolve. While integrating technology to support stakeholder communication is essential, savvy operations leaders also prioritize es­tablishing open communication channels. By embracing diversity and cultivating less transactional, more relationship-focused interactions, we enhance our ability to ab­sorb disruptions and promote trans­parency, trust, and clear communication for the present and future.

These open channels are further strengthened by real-time data sharing from supply chain managers, suppliers, and manufacturers, which is crucial in proactively identifying potential disrup­tions. Working collaboratively, stakehold­ers develop best practices and optimized contingency strategies, allowing for a rapid, coordinated response to challenges. This minimizes the impact on supply chains and, most importantly, ensures an uninterrupted supply of products to pa­tients. Such dynamic communication is in­valuable for swiftly pivoting strategies, whether adjusting mid-trial for direct-to/from patient shipments or other decen­tralized services. A resilient supply chain, ready to adapt to any circumstance, relies heavily on robust communication and transparency throughout its network.

WHAT’S INSIDE THE BOX: REAL-TIME TRACKING FOR DATA-DRIVEN DECISION MAKING

Enhancing supply chain visibility and traceability is a key enabler for building a resilient supply chain able to overcome challenges and engrain the highest level of quality into processes. Recent acceler­ated research in new modalities of medi­cine, sponsors seek deeper, product-level visibility on shipments of advanced thera­pies — an “inside-the-box view” to se­curely monitor status throughout the jour­ney.² This involves implementing cutting edge, end-to-end supply chain tracking systems with data analysis for real-time visibility into the condition and movement of goods from the production stage to the end-user. These systems are powered by limitless technological solutions like radio frequency identification tags, sensors, and barcodes, as well as digital platforms — covering every angle to provide granular data on the location and condition of bio­logical samples and medical products.

Real-time data analytics empower op­erations teams to identify potential bottle­necks and disruptions early, enabling proactive management of inventory levels, transportation routes, and delivery sched­ules. This approach not only prevents drug shortages and delivery delays, but also maintains the integrity of temperature-sen­sitive materials and optimizes inventory.

Interoperability between teams, facil­itated by integrated, cross-organizational platforms, is vital for achieving complete transparency. Specialty supply chain re­silience involves leveraging various tech­nologies and digital tools to enhance supply chain transparency — key factors in building patient confidence and ensur­ing secure medication delivery.³ At Marken, our proprietary Marken Maes­tro™ software provides patients and spon­sors with a transparent view of the product’s journey, offering secure, real-time updates on conditions and GPS track­ing.

Regular assessments and stress test­ing evaluate the impact on supply chain resilience. Developing a comprehensive risk framework helps identify and prioritize potential disruptions, allowing for the im­plementation of effective mitigation plans. This process encompasses a wide range of factors, such as geopolitical events, natu­ral disasters, transportation challenges, economic impacts, and regulatory changes. Successful strategies that consis­tently manage disruptions are integrated into our best practice framework, enhanc­ing agility and ensuring patient access to life-saving medications.

Elevating visibility within the supply chain cultivates a culture of risk awareness and preparedness across the organization. It’s imperative for leadership teams to em­body and promote critical thinking in the face of disruptions, fostering a resilient supply chain culture. This involves every network level, from the C-suite to frontline employees, in identifying risks, conducting regular assessments, applying risk man­agement principles, and integrating find­ings into decision-making. By nurturing a culture of risk awareness, organizations can effectively anticipate, respond to, and recover from disruptions, ensuring uninter­rupted delivery of essential medicines.

REDEFINING SUPPLY CHAIN RESILIENCE THROUGH INNOVATIVE TECHNOLOGY SOLUTIONS

A flexible, ready-to-pivot supply chain requires the integration of groundbreaking digital technologies. The use of advanced tools like AI, data analysis, and industry cloud computing is revolutionizing the field. These technologies not only stream­line operations, but also enhance data capture, leading to more intelligent deci­sion-making. This evolution benefits pa­tients and sponsors with reduced costs, faster turn-around-times, and refined in­ventory management (reducing the over­age required).

AI and machine learning (ML) are particularly transformative, optimizing re­sources and predicting demand fluctua­tions with greater accuracy. AI algorithms utilize both current and historical data to sharpen demand forecasts. Meanwhile, ML minimizes the risks associated with in­ventory shortages or surplus. Additionally, AI and automation are pivotal in boosting productivity and minimizing human error. For instance, automated robotic systems efficiently handle repetitive tasks like med­ication picking and packing, enhancing accuracy and overall efficiency. The future of these technologies promises even more advanced capabilities, such as automated contingency responses, potentially meeting patient needs with unprecedented speed and resource optimization.

Effective communication technology is also vital in fostering collaboration and partnerships within the pharmaceutical supply chain. The industry’s shift toward integrated, industry-cloud solutions demonstrates a growing recognition of the value these technologies bring. They are instrumental in enhancing collaborative projects, allowing for the efficient sharing of information, best practices, and re­sources. This collective approach ad­dresses common challenges and significantly improves supply chain per­formance.⁴

Leveraging AI for smart shipment management, including location GPS data, will provide further predictive capac­ity with live insights and in-depth analysis of various external factors, including labor shortages, conflict zones, adverse weather conditions, and congested or hazardous road conditions – in addition to other on­going global disruptions.

For instance, consider Marken’s Monarch, an innovative, efficient and sus­tainable packaging solution for transport­ing and safeguarding temperature-critical clinical pharmaceuticals across the globe. With temperature-range capabilities from ambient to deep frozen (-80°C), it goes beyond the dimensions of performance with internal and external sensors that monitor real-time container performance, ensuring we grasp a holistic view of the shipment’s environment and can make proactive data-driven decisions.

A recent example involved an unex­pected FDA hold on a Marken Monarch shipment. While such unforeseen disrup­tions can be catastrophic, we were able to actively monitor the shipment performance throughout the 3-day delay to ensure the packaging upheld temp conditions. Re­ceiving this live data and vigilant oversight was key – we were able to make the strate­gic decision to then distribute the shipment in a temperature-controlled vehicle (TCV) to its final destination, which confirmed adherence to the strict time and temp re­quirements.

This approach embodies proactive forecasting and heightened situational awareness where we don’t just track data; we harness it, leveraging real-time analyt­ics to inform and drive our decisions. Looking forward, as technology continues to evolve, we anticipate a future in which these critical decisions are executed au­tonomously, ensuring even swifter resolu­tions without the need for human intervention. These advantages are revo­lutionary for clients and patients alike, with levels of oversight, efficiency, and foresight we have not seen before.

SUMMARY

Building a resilient pharmaceutical supply chain requires a comprehensive approach that includes diversification planning, advanced technology invest­ment, collaboration, and enhanced visibil­ity. By diversifying supply sources, improving visibility, prioritizing risk man­agement, and leveraging digital technolo­gies, pharmaceutical companies forge a supply chain that is both robust and flexi­ble, capable of withstanding disruptions and ensuring continuous access to essen­tial medicines.

In light of recent challenges, innova­tion and adaptation have become imper­ative for bolstering supply chain resilience. As the pharmaceutical industry evolves, so too must our supply chain management strategies. Embracing change and adapt­ing to new trends are necessary to main­taining the security and efficiency of our supply chains.

By embracing change and mitigating disruption, Marken is able to offer an agile and limitless supply chain network that im­proves healthcare accessibility and equity globally. Marken’s robust global network, combined with cutting-edge digital tools and a patient-centric mindset, optimizes logistics efficiency and flexibility to ensure the distribution of innovative drugs, treat­ments, and other clinical products to those who need it most. Where there is a need, Marken makes it happen.

REFERENCES

1. Council of the European Union. (2023, June). Impact of Russia’s inva­sion of Ukraine on the markets: EU response. Retrieved from consilium.europa.eu.
2. EY. (2023, October). EY report finds cracks in supply chain operations. Re­trieved from ey.com
3. EY. (2023, October). Why digital sup­ply chain visibility should be a pharma priority. Retrieved from ey.com
4. BMC Health Services Research. (2023, June). Exploring the role of ICT in pharmaceutical supply chain practices. Retrieved from bmchealth­servres.biomedcentral.com.

Nina Vas is the Vice President of Global Quality Assurance at Marken, where she is responsible for managing the quality and global GMP depot network of the company. With 25+ years’ experience in the life science, supply chain and project management, her main focus is leading and driving the quality strategy as well as overseeing Marken’s global GMP storage facilities, including Centres of Excellence for ultracold and cryogenic storage. Nina brings a wealth of experience in operational, quality, and process improvement, having managed the performance of the full supply chain to support the distribution of clinical trials to global destinations.