Agenda
Our comprehensive education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharmaceutical industry.
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Sustainability - Supply Chain Resiliency
Mon, 14 Oct
Tue, 15 Oct
1000 – 1030
Whole Life Carbon & Pharma Manufacturing Exemplar Study
Sustainability - Supply Chain Resiliency
Michael Keohane, PM Group
Buildings account for almost 40% of global greenhouse gas (GHG) emissions. This relates to emissions arising from materials of construction and operational emissions such as energy. The global transition to Net-zero will require decarbonization changes across all elements of society, including the way we design our buildings and manufacture products. Decarbonization strategies for manufacturing facilities, both existing and new build, are essential.To achieve Net-zero Buildings, the embodied carbon emissions associated with building construction must be understood and reduced. Reducing operational emissions alone will not achieve Net-zero. Regulatory authorities globally are now recognizing this and introducing legislation for the reporting of whole life carbon emissions associated with building construction.This presentation will provide an insight into the source of carbon in pharmaceutical buildings with case study findings on whole life carbon assessment of pharma manufacturing facilities. An overview of life cycle assessment (LCA) for carbon emissions will be provided including the challenges & design strategy opportunities for the construction of industrial buildings.
1030 – 1100
Our Journey Towards Low Embodied Carbon Facilities
Sustainability - Supply Chain Resiliency
John Magner, Johnson & Johnson
Supporting J&J's vision for a sustainable future is their commitment to sustainable facilities. Recognizing the importance of what we build and how we build, we started a challenging initiative last year, focusing on embodied carbon emissions for our capital construction projects. While operational carbon emissions have received significant attention, embodied carbon remains relatively unknown in the construction sector and within our Project Delivery teams (PD). Our mission was clear: to bring clarity and quantification to the concept of embodied carbon in our construction projects and look for opportunities to reduce our footprint. We asked an external consultant to provide us this quantification based on 3 pilot projects. This mission gave us interesting insights into our carbon footprint, providing us with key takeaways to integrate into our future projects. Furthermore, we worked towards generic guidelines on how to implement embodied carbon reduction strategies into our future construction projects. Our next steps involve disseminating these insights to our global Project Delivery and Engineering team, ensuring this knowledge becomes embedded in our organization. Additionally, we aim to establish a benchmark to implement sustainable practices across our entire (future) building portfolio.This way we put our corporate’s sustainability ambitions to practice in our facilities.
1100 – 1130
Realizing Our Bold Sustainability Ambition
Sustainability - Supply Chain Resiliency
Kevin Conkright, AstraZeneca
Allen Koester, PCI (A Salas O'Brien Company)
Sustainability is a focus area in the pharmaceutical industry. The pharmaceutical industry is a customer focused industry that puts its patients first. A sustainable process is healthy for our environment. A healthy environment supports a healthy patient. AstraZeneca has a bold sustainability ambition which includes being carbon neutral by 2025. Our presentation will display the journey of the Mt. Vernon AstraZeneca Supply Site to becoming a sustainable manufacturing facility achieving carbon neutrality by 2025. This journey highlights a true corporate commitment, the role of technical partnerships, the importance of engaging your team across all levels, and of capitalizing on both big and small opportunities.
1300 – 1330
ReVAMP Drug Supply Chain Consortium Progress and Outlook
Sustainability - Supply Chain Resiliency
Stephen Colvill, Duke-Margolis Center for Health Policy
Supply chain reliability is top of mind in the U.S. and globally. Supply chain breakdowns from manufacturing quality issues and other disruptive events are too frequently causing drug shortages with devastating impacts on patient care.Recently launched in 2023, the Duke-Margolis Institute's ReVAMP Drug Supply Chain Consortium is driving robust discussion on drug supply chain improvement opportunities for the US market. The Consortium’s mission is to generate effective policy solutions that promote a reliable drug supply chain with advanced manufacturing capabilities and, ultimately, to improve patient outcomes by reducing the frequency and severity of drug shortages. Based on input from a wide range of experts involved in manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium puts forward written policy recommendations and other work products to advance these aims. The Consortium aims to build a drug supply chain that ensures patients access to safe and effective drugs, in adequate quantities, when they’re needed.
1330 – 1400
Drug Shortage Prevention: Where are we?
Sustainability - Supply Chain Resiliency
Jessica Hale, Merck & Co Inc
The regulatory landscape related to drug shortage prevention has changed over the last several years due to large-scale, highly visible events (e.g., COVID-19 pandemic, geopolitical issues, hurricanes, etc.). Rapidly evolving drug shortage requirements followed and has generated nuanced differences across multiple markets in definitions/ approaches, reporting expectations, and risk management planning. As a result, ISPE formed a Global Convergence Opportunities team with its Drug Shortages Initiative to assess trends in drug shortage-related requirements and identify opportunities to harmonize definitions and approaches across markets. This presentation will discuss the findings and correlating recommendations being made in the interest of bolstering supply chain resiliency.
1400 – 1430
Global Post-Approval Changes and Drug Shortages
Sustainability - Supply Chain Resiliency
Chris Musteikis, Gsk
How do differences in global requirements and filing timelines lead to drug shortages?
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.Please note that this speaker is not a regulator, but it would be good to have a regulator speak in a session with this talk bundled with one or more of the Drug Shortage sessions. US FDA Drug Shortage Staff (E. Thakur or team) are suggested.
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.Please note that this speaker is not a regulator, but it would be good to have a regulator speak in a session with this talk bundled with one or more of the Drug Shortage sessions. US FDA Drug Shortage Staff (E. Thakur or team) are suggested.
1530 – 1600
Be Ready: Scope 3 and Product Sustainability at Sites
Sustainability - Supply Chain Resiliency
Sarah Mandlebaum, Takeda
We aim to delve into the critical connection between high-level sustainability goals, such as Net-Zero Climate, and the necessity for data transparency in product manufacturing. By examining the role of data transparency within the supply chain (scope 3) and the manufacturing facility (scope 1 and 2), this presentation will shed light on how data can drive sustainable practices through informed decision-making, process optimization, collaboration with suppliers, and resource usage optimization. The presentation will discuss how product design influences site operations and energy/waste reduction. Additionally, it will explore how sites utilizing renewable energy and innovative manufacturing equipment and techniques can further minimize product footprints. The shift towards data-driven product-level emission calculations for Scope 3 reporting will be examined, along with how manufacturing sites can provide this data using Bill of Materials (BOMs), metering, and allocation. A case study will be presented to showcase these concepts in action, providing practical examples of how data transparency drives sustainable practices and contributes to the achievement of high-level sustainability goals.
1600 – 1630
Trends in Injectable Manufacturing Investment Strategy
Sustainability - Supply Chain Resiliency
Christopher Schwartz, L.E.K. Consulting
Given the lag time between an investment decision and having a sterile injectable facility ready to produce commercial product, having a robust manufacturing and supply chain strategy is critical to the success of sterile injectable manufacturers. In recent years, there have been many direct and indirect shocks to sterile injectable supply chains including COVID disruptions, the rise and fall of COVID vaccine demand, the explosion of GLP-1's, the signing of the Inflation Reduction Act, and a spike in interest rates. These events and trends have required sterile injectable manufacturers and CDMOs to reevaluate their manufacturing investment and supply chain strategies to efficiently allocate capital while building resiliency. This presentation is intended deep dive into the impact of these recent trends and hypothesize the future of sterile injectable manufacturing investment and supply chain strategies.
1630 – 1700
The Simplicity of Sustainability
Sustainability - Supply Chain Resiliency
Jochen Schlag, Belimed Life Science
Sustainability is a term that is currently in the spotlight almost everywhere in the world. Thereby sustainability does not have to mean doing without but should be seen from the perspective of saving. Because if resources can be saved, money can also be saved. As a rule: It doesn't have to be expensive technologies such as nuclear fusion research or battery storage. There are also much simpler ways. The pharmaceutical world in particular requires a lot of energy and resources. Reducing these is not rocket science if you follow a few basic rules and focus on the right type of energy. Where is the most energy needed? What is the best technology for heating a medium? Can energy be recovered? A great deal can be achieved with a simple approach. What do you think takes more energy: Heating 1 gallon of water by 50°F or the same amount of stainless steel by the same temperature?
1015 – 1045
Sustainability - European Regulations for 2025
Sustainability - Supply Chain Resiliency
Nissan Cohen, Biopharmaceutical Water Doc
There is a new European directive EUR-Lex - 32022L2464 - EN - EUR-Lex (europa.eu). In 2025, large companies will have to report, in a more stringent way than 2023, on their data and actions of 2024 for sustainability. In 2026, all European companies with more than 250 employees will have to report on the data and actions of sustainability from the operations during 2025. This is a more stringent and more complex reporting, than any previous year. According to the directive, reporting will have to be approved by external statutory auditors, as per financial reports and report all actions for sustainability.
1045 – 1115
Building a More Resilient Public Health Industrial Base
Sustainability - Supply Chain Resiliency
Arlene Joyner, PCI/BARDA/ASPR/HHS
The global COVID-19 pandemic exposed weaknesses in a supply chain that relies heavily on just-in-time manufacturing for personal protective equipment (PPE), medical equipment, and pharmaceuticals. Critical components involved in every step of development and distribution of medical countermeasures (MCMs), from raw materials to intermediate steps to tools that facilitate product delivery, experienced bottle necks during the pandemic. The world competed for the same supplies to meet the demands brought on by surging cases and exposed major vulnerabilities to foreign sourced products. This was keenly felt with critical medicines required to treat the most vulnerable patients. This dependency on foreign suppliers and developers resulted in high drug prices and, in many cases, shortages. This discussion will offer lessons learned from the pandemic, the current state of the domestic medical supply chain and measures IBMSC is taking to ensure our medical supply chain is robust and prepared to tackle any future medical domestic supply chain events with full confidence. This session will examine the USG posture pre- and during the COVID-19 pandemic, explore the lessons learned from the pandemic, the technological advances that have been made since the start of the pandemic, and examine the future of the medical supply chain.
1115 – 1145
Sustainably Controlling Odorous Off-Gas from Production Repl
Sustainability - Supply Chain Resiliency
Bill Celenza, Burns & McDonnell
Afolabi George, AbbVie
Pharmaceutical manufacturing employs a variety of production processes that generate off-gas containing potentially odorous molecules. Controlling these compounds is crucial for protecting a community from unpleasant odors and health risks, and pharmaceutical makers employ a variety of technologies to treat such potential odor sources. As pharmaceutical production facilities seek to establish more rigorous standards for emission control, optimal control systems must mitigate odors in even the most challenging conditions, remain resilient to potential failure modes, and align with each facility’s budget and operational constraints. Comprehensive modeling and system design processes are critical to thoroughly consider when implementing or upgrading off-gas control systems at pharmaceutical production plants. The ideal mix of emission control technologies is a balancing act of cost and capabilities that must be carefully aligned to the unique requirements of each manufacturing facility.
1530 – 1700
Flexibility & Sustainability in Pharma Manufacturing
Sustainability - Supply Chain Resiliency
James Fisher, Amgen Inc
There is growing importance of flexibility and sustainability in the pharmaceutical manufacturing industry. This session will discuss the challenges and solutions for supporting a highly flexible supply chain in a varying drug product environment, explore the boundaries of flexible facility design, highlight the key principles for agile/flexible facilities, showcase the successful integration of environmental sustainability into capital project delivery process, and recognize the results of being green from the start. These topics demonstrate the importance of planning, innovation, and adaptability in achieving sustainability and flexibility in the pharmaceutical industry.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Programme Changes
Programme is subject to change. Last minute changes due to functional, private, or organisational needs may be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme.