Supply Chain Resiliency and Sustainability: Transforming Pharma at the 2024 ISPE Annual Meeting

This track promises to deliver valuable takeaways that will propel professional journeys forward for those looking to expand their networks, enhance their skill sets, or learn more about a new subject. Attendees will gain valuable insights from industry leaders, learn about the impact of global regulatory approaches on drug shortages, and discover how to implement effective sustainability initiatives throughout the pharmaceutical supply chain.

Industry efforts to reduce carbon emissions and align with global net-zero ambitions

The carbon reduction session is a testament to the pharmaceutical industry's commitment to sustainability. Johnson & Johnson’s initiative to quantify embodied carbon emissions in their construction projects is a pioneering effort to reduce their carbon footprint and align with global net-zero ambitions. This initiative has led to the development of guidelines for future projects and is part of a broader effort to embed sustainability into Johnson & Johnson’s organizational ethos.

Similarly, AstraZeneca's journey towards carbon neutrality by 2025 at the supply site in Mt. Vernon, Indiana, USA, is another example of the industry's dedication to sustainable practices. Their approach highlights the importance of corporate commitment, technical partnerships, team engagement, and seizing opportunities to make a substantial impact on the environment and patient health.

Initiatives and recommendations to address the issue of drug shortages and improve the reliability of the drug supply chain

A series of sessions will explore the critical issue of addressing the ongoing challenge of drug shortages. One of the presentations will discuss the policy proposals put forth by the Duke-Margolis ReVAMP Drug Supply Chain Consortium. These proposals are designed to create a supply chain that not only guarantees access to safe and effective medications for patients but also supports the development of a skilled workforce to sustain these advancements. The ReVAMP Drug Supply Chain Consortium, initiated by the Duke-Margolis Institute in 2023, is leading the conversation on enhancing the US drug supply chain. The consortium is committed to fostering a reliable drug supply chain bolstered by advanced manufacturing and workforce development programs. These initiatives are pivotal in cultivating a strong knowledge base in advanced manufacturing, which is essential for reducing drug shortages and improving patient care.

Furthermore, the rapidly evolving drug shortage requirements have generated nuanced differences across global markets in definitions/approaches, reporting expectations, and risk management planning. ISPE's Global Convergence Opportunities team within its Drug Shortages Initiative is working to harmonize drug shortage-related requirements across multiple markets. The team will discuss findings, assess trends, and identify opportunities for convergence, with the goal of bolstering supply chain resiliency.

Lastly, another presentation on the topic of drug shortages will dive deeper into whether differences in global requirements and filing timelines are leading to drug shortages. This session includes a comparison of the regulatory requirements and timelines in several global markets, including the US, EU, and Asia-Pacific regions. A case study will be presented to illustrate the real-world consequences of extensive requirements and long review timelines, which can hinder the implementation of new technologies and delay updates critical to sustaining drug supply. These delays can prevent new medicines from reaching patients worldwide and put existing products at risk of shortage. This session will propose regulatory solutions and suggest reliance models that can be adopted by global regulatory agencies to ease reviewer burdens, accelerate review processes, and reduce drug shortages.

*Restrictions apply. Offer applies to In-Person All Access or In-Person Essentials Pass member/non-member rates only. Offer ends at 2359EST on Friday, 19 July 2024.

The practical aspects of resource and energy savings in the pharmaceutical industry

The first presentation on the topic of resource and energy savings will emphasize the critical role of data transparency in achieving high-level sustainability goals such as net-zero emissions. It will explore how data transparency within the supply chain and the manufacturing facility can drive sustainable practices through informed decision-making, process optimization, collaboration with suppliers, and resource usage optimization. The influence of product design on-site operations and energy/waste reduction will be discussed, along with the benefits of renewable energy and innovative manufacturing equipment and techniques in minimizing product footprints. The presentation will showcase all these concepts in action as part of the case study with practical examples of how data transparency can contribute to the achievement of high-level sustainability goals.

With fluctuating demands for the COVID-19 vaccine and the explosion of GLP-1s sterile injectables manufacturers and contract manufacturers (CDMOs) are focusing on ensuring the robustness of their manufacturing and supply chain strategy. One of the presentations in this session will delve into the strategic considerations for sterile injectable manufacturers and CDMOs to efficiently allocate capital while building resiliency. It will offer a deep dive into the impact of these disruptive factors and hypothesize the future of sterile injectable manufacturing investment and supply chain strategies.

The last presentation on this topic focuses on achieving sustainability goals with the outcome of reducing operational costs. This presentation will shed light on the practical aspects of resource and energy savings in the pharmaceutical industry. It will challenge the audience to consider the energy requirements of common processes and materials, advocating for a simple yet effective approach to energy conservation.

New EU directives on sustainability reports, implications, and lessons learned

A session on building a more resilient public health industrial base will delve into the vulnerabilities exposed during the pandemic, the current state of the domestic medical supply chain, and the proactive measures the Office of Industrial Base Management and Supply Chain (IBMSC) is implementing to fortify against future challenges. The global COVID-19 pandemic highlighted the vulnerabilities of a supply chain heavily reliant on just-in-time manufacturing for medical equipment and pharmaceuticals. This presentation will examine the USG posture pre- and during the pandemic, the technological advances made since its onset, and the future of the medical supply chain.

The session on sustainability and regulations will address the new European directive which mandates more stringent reporting on sustainability data and actions starting in 2025 for large companies, and in 2026 for all European companies with more than 250 employees. This directive requires external statutory auditors to approve sustainability reporting, like financial reports, and to report all actions for sustainability. The heightened focus on sustainability and the impending European directive underscores the need for more stringent and complex reporting.

The last presentation of this session will discuss the importance of controlling off-gas emissions in pharmaceutical manufacturing processes to protect communities from odors and health risks. It will highlight the need for optimal control systems that are resilient to failure modes, align with budget and operational constraints, and meet rigorous standards for emission control. The presentation highlights the significance of comprehensive modeling and system design processes in the implementation or upgrade of off-gas control systems. This presentation emphasizes that the ideal mix of emission control technologies is a balancing act of cost and capabilities, tailored to the unique requirements of each manufacturing facility.

Measures to ensure robustness and preparedness for future sustainability in facility design and operations

The panel discussion on sustainability in facility design and operations will focus on the complexities of supporting a sustainable supply chain in a dynamic drug product environment. It will address the challenges of planning for numerous filling line and syringe configurations across a manufacturing network, the associated costs and time implications, and strategies for gaining efficiency in clinical manufacturing production. The panel will explore the study of process and container changes, the capabilities of fill lines, and discuss a solutions-based plan for successful drug product planning for a highly flexible supply chain. The role of flexible facility design in ensuring adaptability, efficiency, and compliance with regulatory requirements will be highlighted, along with the alignment of strategies with company values and project goals. Attendees will learn about the factors influencing the need for flexibility, current trends, and the challenges and limitations that come with them. The successful integration of environmental sustainability into capital project delivery processes for both small and large projects, showcasing the results of being green from the start as demonstrated at Amgen’s Ohio greenfield facility.

Together, these presentations and discussions at the 2024 ISPE Annual Meeting & Expo reflect a holistic approach to sustainability and supply chain reliability in the pharmaceutical industry, emphasizing the need for a transition to net zero and a resilient drug supply chain. Don't miss this opportunity to connect with peers, learn from experts, and be part of the conversation on building a sustainable future. ISPE looks forward to attendees’ participation in these important sessions that promise to inspire action and drive change.

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