Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.
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Sun, 26 Oct
Mon, 27 Oct
Tue, 28 Oct
Wed, 29 Oct
0700 – 1800
Registration will also be open on Saturday 25 October 2025 from 0700-1800.
0730 – 1300
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution.
1300 – 1600
Workshops
1300 – 1600
Workshops
Timothy Graul, Pfizer, Inc.
Mary Beth Pelletier, PhD, Apogee Therapeutics
Nina Cauchon, Amgen Inc.
The ICH Q14 guideline provides a science- and risk-based approach to developing and maintaining analytical procedures, ensuring they remain fit for purpose throughout a drug’s lifecycle. However, implementing changes to analytical procedures remains complex due to regulatory variations across global markets. The adoption of ICH Q14, alongside principles from ICH Q12, offers the promise of a streamlined postapproval change management process that reduces regulatory burden while maintaining compliance. This interactive workshop organized by the ISPE PQLI ICH Q2(R2)/Q14 Analytical Method Strategy team will explore how analytical procedure changes can be facilitated through case studies on method changes, column and instrument transitions, platform method adaptations, and the utilization of established conditions (ECs) and post-approval change management protocols (PACMPs). These examples highlight how the use of risk assessment and performance-based criteria streamline post-approval changes while ensuring robust product control. By leveraging ICH Q14’s flexible framework, companies can integrate new technologies, improve laboratory efficiency, and ensure pharmaceutical quality in an efficient manner. The ultimate goal is to enhance innovation, optimize supply chains, and deliver safe, effective products to patients faster.
1300 – 1600
Workshops
Sharyn Farnsworth, Fujifilm Diosynth Biotechnologies
Robert Dream, HDR COMPANY LLC
Jeffery Odum, Genesis AEC
Andrew Sinclair, Biopharm Services Ltd
The growing number of potential high-volume molecules being evaluated to determine a manufacturing strategy is moving companies to investigate CBM as an alternative to batch-based platforms. Faced with making this choice between a traditional fed-batch manufacturing platform and moving to a continuous/perfusion-based process, what are the sourcing decisions that must be addressed? Workshop attendees will be provided with process, equipment, and operational information to identify the KPIs for driving the sourcing decision and to create options that identify the advantages and disadvantages of moving to a CBM platform. The Workshop will address risk identification, CBM vs. Batch-based pros/cons, COGs analysis, regulatory considerations, and the impacts on Capital Investment. Using recent ISPE publications and the new ISPE Guide for Continuous Biomanufacturing of Large Molecule Drugs as references, Attendees of this workshop will use case study examples to define key decision parameters for making go/no-go choices to implement CBM that invokes smart manufacturing, data integration, and real-time monitoring, and enhanced QbD attributes.
1300 – 1600
Workshops
Frank Henrichmann, Q-FINITY Quality Management
In this engaging, hands-on workshop on the practical implementation of AI in GxP-regulated environments, participants will actively engage in key activities essential for successfully introducing and implementing a GMP-relevant system incorporating AI/ML components. They will explore key aspects of AI adoption in the pharmaceutical industry by applying ISPE Pharma 4.0® and GAMP® principles, including:
Participants will have the opportunity to discuss these aspects with their peers and industry experts and gain valuable insights into the validation aspects of AI/ML solutions and the associated challenges in digital transformation.
- Maturity assessment techniques to evaluate organizational readiness for digital transformation.
- Risk assessment methodologies tailored to AI solutions, ensuring patient safety, data integrity, and product quality.
Participants will have the opportunity to discuss these aspects with their peers and industry experts and gain valuable insights into the validation aspects of AI/ML solutions and the associated challenges in digital transformation.
1300 – 1600
Workshops
James Wabby, AbbVie, Inc.
Kent Abrahamson, AbbVie
Fubin Wu, GessNet
Juan Cheng, Merck
This workshop provides an integrated view of the essential processes needed for the development of safe, effective, and reliable combination products. It encompasses Design Controls, Drug Development, Risk Management, Safety Assurance, and Reliability processes, highlighting their interrelations and dependencies. By incorporating this structured approach, organizations can improve efficiencies and reduce regulatory risks while ensuring safety and effectiveness. The complexity of drug-device combination products introduces unique challenges compared to standalone drugs or medical devices. Existing regulatory frameworks such as Quality by Design (QbD), design controls, and risk management were developed separately and may not fully address the integration required for combination products. This class will demonstrate how a holistic and structured approach enhances these frameworks to define, implement, verify, validate, and maintain product safety and effectiveness across the lifecycle.
This workshop will explore:
Additionally, model-based systems engineering (MBSE) will be introduced as a digital framework to systematically manage safety- and effectiveness-critical functions, ensuring a proactive and data-driven approach to combination product development. Attendees will explore key concepts through a combination of lectures, real-world case studies, and hands-on activities, equipping them with practical strategies to address the unique challenges of combination products, navigate evolving regulatory expectations, and foster innovation while ensuring compliance.
This workshop will explore:
- The benefits of proactive modeling in streamlining the integrated approach to combination products, focusing on safety, reliability, and effectiveness.
- The role of digital traceability in QbD, design controls, risk management, and lifecycle management.
- How to effectively leverage the large amounts of data generated during testing and manufacturing to identify and refine specifications and integrate them into risk management processes.
Additionally, model-based systems engineering (MBSE) will be introduced as a digital framework to systematically manage safety- and effectiveness-critical functions, ensuring a proactive and data-driven approach to combination product development. Attendees will explore key concepts through a combination of lectures, real-world case studies, and hands-on activities, equipping them with practical strategies to address the unique challenges of combination products, navigate evolving regulatory expectations, and foster innovation while ensuring compliance.
1900 – 2230
Join ISPE to celebrate the 2025 FOYA Banquet and Awards Celebration where we will formally recognize and celebrate the 2025 Category Winners' achievements. Please note that separate registration is required.
0700 – 0800
0700 – 1600
0800 – 0830
General Session
0830 – 0840
General Session
Gunter Baumgartner, Takeda Pharmaceuticals International AG
0840 – 0910
Brendan O'Callaghan
Executive Vice President Manufacturing and Supply
Sanofi
Executive Vice President Manufacturing and Supply
Sanofi
0910 – 0940
0940 – 0945
0945 – 1045
0945 – 1915
1045 – 1115
Advanced Therapy Medicinal Products (ATMPs)
1045 – 1115
Digital Transformation
Terri Melzer, Bristol Myers Squibb
Pamela Paddock, JLL
This presentation will explore Bristol Myers Squibb's digital organizational transformation in partnership with JLL. Terri Melzer, Senior Director Global Facilities Services at Bristol Myers Squibb will join Pam Paddock as an expert speaker for this session. Together we will discuss how BMS is setting the foundation for future flexibility through cutting-edge technologies, AI-driven analytics, and cloud-based platforms. This organizational transformation will drive efficiency, reduce costs, and enhance compliance across their portfolio of lab, manufacturing, and office facilities.
Key focus areas include:
Implementing a modern CMMS and data backbone to consolidate systems and provide enterprise-wide visibility.
Deploying smart building technologies to enable predictive maintenance and optimize energy usage.
Utilizing AI and machine learning to drive data-driven decision-making for asset management and capital planning.
Streamlining regulatory compliance and documentation through digital tools.
Implementing reliability-centered maintenance to capture asset condition, uncovering data-driven TCO strategies for asset management
Transforming vendor relationships and contracts from task-based agreements to outcome-focused partnership agreements.
Attendees will discover how biopharma organizations can kickstart a digital transformation journey, no matter an organization’s size. Attendees will gain insights on how to leverage Industry 4.0 technologies to modernize pharma facilities management and unlock new value.
Key focus areas include:
Implementing a modern CMMS and data backbone to consolidate systems and provide enterprise-wide visibility.
Deploying smart building technologies to enable predictive maintenance and optimize energy usage.
Utilizing AI and machine learning to drive data-driven decision-making for asset management and capital planning.
Streamlining regulatory compliance and documentation through digital tools.
Implementing reliability-centered maintenance to capture asset condition, uncovering data-driven TCO strategies for asset management
Transforming vendor relationships and contracts from task-based agreements to outcome-focused partnership agreements.
Attendees will discover how biopharma organizations can kickstart a digital transformation journey, no matter an organization’s size. Attendees will gain insights on how to leverage Industry 4.0 technologies to modernize pharma facilities management and unlock new value.
1045 – 1115
Regulatory - Compliance & Quality
Elaine Lowell, Takeda Pharmaceuticals Inc.
In the rapidly evolving landscape of Regulatory, Compliance, and Quality, the integration of Pharma 4.0 principles is essential for accelerating drug development and ensuring patient safety. This presentation will explore how our organization has successfully built a quality culture by incorporating Software Quality Engineers (SQEs) into our team. By leveraging AI to build a community of practice, integrating cross-functional input, and utilizing digital tools like SAP SuccessFactors and Power BI, we have enhanced our quality standards and operational excellence. Objectives:
1) To demonstrate the role of Software Quality Engineers in fostering a quality culture within the organization.
2) To highlight the integration of Pharma 4.0 principles in enhancing quality and compliance.
3) To share best practices and lessons learned from our journey in building a quality-focused team.
1) To demonstrate the role of Software Quality Engineers in fostering a quality culture within the organization.
2) To highlight the integration of Pharma 4.0 principles in enhancing quality and compliance.
3) To share best practices and lessons learned from our journey in building a quality-focused team.
1045 – 1115
Sustainability & Supply Chain Resiliency
Liz Dooley, Johnson & Johnson
Alfred Penfold, PM Group
It is not always the case that a more sustainable design can lead to many opportunities such as a reduction in operating cost and associated improvements in productivity and quality. However, the HVAC design is one such opportunity which typically represents anything from 50% to 80% of the total energy consumption of a new facility. The high percentage reflects the stringent requirements for maintaining controlled environments, including temperature, humidity, and air quality that are critical when meeting the Annex 1 requirements for the production and storage of pharmaceutical products. Europe is developing directives to improve the sustainability of facilities and products by incorporating these objectives into their regulations. Learn how to design more sustainable HVAC systems for cleanroom environments that comply with Annex 1.
1045 – 1115
Manufacturing - Quality Control & Operational Excellence
Wei Huang, Henlius Biopharmaceutical Ltd
Advancements in biologics manufacturing and quality control have driven the development of novel technologies aimed at improving efficiency, consistency, and safety in the production of therapeutic biologics. The speaker will present some of the recent developments in continuous bioprocessing and real-time analytics. The integration of artificial intelligence (AI) into process optimization and predictive analytics to improve manufacturing operation excellence. The impact of these technologies on scalability, cost-effectiveness, and regulatory compliance is also examined, highlighting their role in meeting the growing demand for biologics. As these innovations continue to evolve, they promise to further streamline production processes and improve the quality and accessibility of biologic therapies.
1115 – 1145
Regulatory - Compliance & Quality
Matteo Bernasconi, AbbVie
Thomas Friedli, University of St.Gallen
The presentation highlights barriers to continuous improvement (CI) in the Pharma Industry and provides insights into coping strategies. The context of the presentation is recent programs to foster advanced quality management practices as well from regulators (e.g. FDA's QMM program) and Industry (e.g. ISPE APQ). The empirical base for the presentation has been build as part of a FDA financed project work. A total of 73 Interviews (over 65 hours of recordings) from 30 companies have been analyzed to develop the results. Qualitative findings from the interviews will be supported by new analysis with quantitative data from St.Gallen's Operational Excellence database to provide a comprehensive in-depth understanding.
1115 – 1145
Sustainability & Supply Chain Resiliency
Christian Lavarreda, Syntegon
Securing leadership support and funding for sustainability initiatives requires compelling business cases that align the environmental benefits with financial and strategic value. This presentation will provide practical guidance on crafting persuasive business cases for sustainability projects in pharmaceutical manufacturing. Drawing on the work of the Circular Economy sub-committee of the ISPE Sustainability Community of Practice (CoP) on this topic, we outline key elements that drive success, including lifecycle cost analysis, risk mitigation, regulatory alignment, and stakeholder engagement. Attendees will gain insights into quantifying sustainability benefits, integrating circular economy principles, and addressing common objections from decision-makers. Case studies will illustrate how well-crafted proposals can translate sustainability goals into actionable investments. Whether advocating for energy efficiency, waste reduction, or green chemistry initiatives, participants will leave with actionable strategies to strengthen their business cases and advance sustainability within their organizations.
1115 – 1145
Manufacturing - Quality Control & Operational Excellence
Line Lundsberg-Nielsen, NNE
Toby Groathouse, Novo Nordisk
Joseph Jerkins, Genentech
In the evolving pharmaceutical manufacturing landscape, Novo Nordisk and Roche have collaborated to enhance production capacity and agility through innovative approaches. This presentation focuses on "Fleet Management" and its potential to reshape the regulatory framework for Distributed Manufacturing. The industry is at a critical juncture, requiring a transition from traditional centralized models to dynamic decentralized systems. Our efforts highlight the significance of digitally connected, standardized facilities within a global network, grounded in harmonization and enhanced connectivity to ensure consistency and quality. The Fleet Management framework introduces a standardized method for managing equivalent manufacturing systems that can be replicated across locations. This presentation will discuss our development of the Fleet concept and its influence on a global Pharmaceutical Quality System. At Novo Nordisk, we are creating a fill & finish manufacturing network to swiftly respond to patient demands. The Fleet Management concept, with standardized manufacturing equipment and real-time monitoring, supports a data-driven performance program. At Roche, the fleet concept has been deployed to a multi-component parenteral packaging platform, enhancing operational efficiency. These initiatives demonstrate how embracing distributed manufacturing can create a more responsive and sustainable pharmaceutical production landscape. Collaboration among regulators and industry stakeholders is essential to implement this innovative framework.
1115 – 1145
Digital Transformation
Rebecca Street-Howard, RoslinCT
Keith Morris, PM Group
RoslinCT, a contract manufacturer of advanced therapeutics, is working to develop pioneering standards to allow Digital Transformation in Cell Therapy Manufacturing. Industrializing Cell and Gene Therapies requires a paradigm shift for the pharmaceutical industry. Currently, the same approach is taken for made-to-stock, large-batch manufacture (200,000 doses per batch) as for made-to-order, personalized medicines (1 dose per batch).
Costs are too high: Healthcare systems cannot afford the medicines
Speeds are too low: Patients deteriorate while waiting for the product to be delivered.
Capacity is too low: There is insufficient manufacturing capacity to meet demand.
The problem is how to release 200,000 batches in the same period and with the same human resources as it currently takes to release a single batch. Digitization plays a central role in solving this industrial problem. It will enable this paradigm shift as it has in other industries, such as the global airline industry, where passenger volumes have nearly doubled over the last 20 years, supported by air traffic control systems and other digital solutions.
Costs are too high: Healthcare systems cannot afford the medicines
Speeds are too low: Patients deteriorate while waiting for the product to be delivered.
Capacity is too low: There is insufficient manufacturing capacity to meet demand.
The problem is how to release 200,000 batches in the same period and with the same human resources as it currently takes to release a single batch. Digitization plays a central role in solving this industrial problem. It will enable this paradigm shift as it has in other industries, such as the global airline industry, where passenger volumes have nearly doubled over the last 20 years, supported by air traffic control systems and other digital solutions.
1115 – 1145
Advanced Therapy Medicinal Products (ATMPs)
Erich Bozenhardt, United Therapeutics
Charles Heffernan, PM Group
ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. These therapies are often referred to as ‘Personalised Medicines’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as aseptic processing requirements and product variability. Traditional manufacturing processes are for synthetically derived compounds (small molecule), or proteins or peptides expressed by cellular systems (large molecule). It is not surprising that there are regulations and guidance specifically for ATMPs such as EudraLex Volume 4, Part IV (EMA), PIC/S Annex 2A, and FDA Guidances. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. Learn how to navigate through some of these differences including when and how to apply Annex 1 (Manufacture of Sterile Medicinal Products), ICH Q9 (Quality Risk Management), and ICH Q5A (viral safety evaluation).
1145 – 1215
Digital Transformation
Tanya Sharma, Assurea, LLC
Bradley Broadway, Gsk
As data exchange within life sciences becomes increasingly decentralized, verifying and tracing source data within layered information systems presents a major challenge. Secure information networks and data sharing are critical. Blockchain-based technologies offer data security, transparency, and traceability. This session will explore various blockchain applications within the pharmaceutical industry, including decentralized identity, secure data storage, and formal verification. A case study will be presented on formal verification, which is a mathematically rigorous method for verifying software correctness, enhancing trust in decentralized software systems, and ensuring compliance with regulatory frameworks such as GxP and 21 CFR Part 11. As the industry moves toward more decentralized systems and emerging technologies like AI evolve rapidly, recognizing the benefits of blockchain will play a critical role in maintaining data integrity. This timely discussion emphasizes the importance of blockchain in safeguarding data in an increasingly complex landscape and with a diverse panel discussion with leaders from various domains ( quality, digital transformation, compliance).
1145 – 1215
Advanced Therapy Medicinal Products (ATMPs)
James Wabby, AbbVie, Inc.
The regulatory landscape for combination products involving cell and gene therapies (CATMP) is complex and continually evolving in the absence of global harmonization. As these technologies become more prevalent, regulators are developing and enhancing regulatory frameworks and guidelines to manage these products throughout their life cycle. This session will offer a comprehensive overview of combination products, focusing specifically on innovative therapies, their delivery mechanisms, the current industry landscape, and the regulatory pathway challenges faced by different types of combination products. The discussion will also focus on global regulatory strategy considerations for combination and stand-alone device development and provide best practice recommendations for navigating the evolving regulatory landscape during clinical development and commercialization. Join us to learn from industry experts and gain practical knowledge to help manage the complexities of combination products and stay ahead in the ever-changing regulatory environment.
1145 – 1215
Sustainability & Supply Chain Resiliency
Heather Walters, CRB Group
The LEED Rating system has long provided a structured pathway for life sciences and manufacturing facilities to meet ambitious ESG and sustainability targets. The newly released v5 places an increased focus on carbon reduction and strengthens requirements for both embodied and operational emissions, helping organizations align with net-zero commitments. As regulatory pressures grow and greater accountability is demanded, LEED v5 supports compliance with evolving disclosure frameworks while enhancing resilience and operational efficiency. The system’s updated material transparency and human health criteria demonstrate leadership in responsible sourcing and workplace wellness, reinforcing ESG commitments. Enhanced reporting requirements ensure organizations can quantify and communicate sustainability achievements, a critical factor for stakeholder confidence and corporate accountability. For energy-intensive industries like pharmaceuticals and biotech, LEED v5 facilitates the integration of renewables, optimized HVAC systems, and carbon tracking strategies to reduce environmental impact. Its expanded focus on climate risk and resilience helps future-proof facilities against regulatory shifts and market demands. By leveraging LEED v5, life sciences firms can design high-performing, sustainable facilities that align with global environmental goals while maintaining competitiveness. The latest version provides a clear framework to drive measurable impact, supporting organizations in meeting the sustainability expectations of investors, clients, and regulatory bodies.
1145 – 1215
Manufacturing - Quality Control & Operational Excellence
Celeste Frankenfeld Lamm, Merck & Co Inc
manufacturing and 3D printing, and the rise of personalized medicine. Modular small-scale production systems are particularly suited to cell and gene therapies and other advanced medicinal products that cater to patient-specific treatments. While significant progress has been made in terms of technological innovation, the enabling of these new manufacturing models and commercial adoption remains limited mainly to regulatory and economic barriers. The ISPE PQLI Transportable/POC Committee was established in 2021 with the purpose of collecting information and assessing the industry landscape with regard to the technologies, best practices, challenges, and regulatory thinking that all impact the realization of these manufacturing platforms. In parallel, over the past few years, regulatory agencies including FDA, MHRA, and EMA have engaged industry and published proposals/papers as part of their effort to initiate dialogue in support of the development of regulatory guidelines. The session intends to provide an industry update based on the activities and findings generated by the PQLI committee.
1145 – 1215
Regulatory - Compliance & Quality
Bryan Ennis, Sware
As AI evolves, its integration into GxP-regulated environments introduces unique compliance challenges. Agentic AI, characterized by its autonomy and decision-making capabilities, has the potential to optimize processes, enhance efficiency, and reduce human intervention. However, ensuring regulatory compliance while leveraging AI's full potential remains a critical concern. This presentation will explore the intersection of Agentic AI and GxP compliance, addressing key considerations such as validation, auditability, data integrity, and risk management. Attendees will gain insights into regulatory expectations, best practices for AI governance, and strategies to align AI-driven processes with industry standards such as FDA 21 CFR Part 11 and EU Annex 11. Case studies and real-world applications will illustrate both the benefits and challenges of implementing AI in regulated environments.
1215 – 1345
1345 – 1415
Digital Transformation
Mags Dalton, PM Group
This presentation explores the practical considerations for designing pharmaceutical facilities in line with Pharma 4.0 principles. Early input in the design stages is crucial for the successful implementation of smart manufacturing solutions, as demonstrated by AstraZeneca's new API Clinical and Commercial Manufacturing Facility in Dublin. This state-of-the-art, paperless, digital smart factory integrates enterprise IT systems with operational technologies to enhance efficiency, quality, and innovation. Key aspects include increased network and infrastructure requirements, the integration of new equipment and software, data transparency, predictive maintenance, digital twins, and smart buildings. These considerations impact various design elements such as automation, instrumentation, electrical systems, and more. Incorporating Pharma 4.0 requirements at the design stage helps avoid costly rework and fosters better collaboration, leading to more effective solutions that align with business and operational strategies.
1345 – 1415
Advanced Therapy Medicinal Products (ATMPs)
Juan Araque, Janssen Pharmaceutica Inc
Commercial manufacturers of advanced therapy medicinal products (ATMP) encounter significant challenges in ensuring scalability and maintaining product quality while complying with stringent regulatory requirements and managing high production costs. Enhancing process understanding is fundamental to addressing these challenges. Causal AI is emerging as a paradigm shift from traditional machine learning methodologies, as it enables the extraction of understanding from observational data by mapping out the causal relationships within the data-generating process. This presentation will delve into the application of Causal AI methodologies in ATMP manufacturing, covering aspects from causal discovery to informing critical business decisions. We will demonstrate how Causal AI capabilities seamlessly integrate essential domain knowledge with state-of-the-art algorithms to facilitate a comprehensive understanding of the main process levers during ATMP manufacturing. Furthermore, we will explore how the integration of manufacturing data with causal inference can significantly bolster decision-making intelligence. Our aim is to highlight the effectiveness of deployed Causal AI solutions that are accessible to both technical and decision-maker stakeholders. Our forward-looking perspective emphasizes the ongoing exploration of Causal AI and its potential to transform decision-making processes by enhancing raw material allocation, streamlining operational workflows, and optimizing the scalability of manufacturing operations.
1345 – 1415
Regulatory - Compliance & Quality
Nicholas Haycocks
Hazem Eleskandarani, CSL Behring
Since the release of the 2nd Edition of ISPE BG 5 Commissioning & Qualification, many companies have embarked on the journey of transforming their C&Q to a robust science & risk-based approach. The Guide Core Team consisted of global experts from service and operating companies. It identifies best practices and provides practical examples to ensure successful project implementation from conceptualization through C&Q completion. Five years later, the journey is facing some challenges due to the nature of our highly regulated industry, the reluctance to change, and the pressure to deliver faster projects with no risk to deliverables (cost & schedule). In addition, Health Authorities have been expecting increased robustness in the planning & execution of Risk-Based Qualification, which requires a deep understanding of the approach. The session will be an educational presentation that reviews the fundamentals of the Risk-Based Qualification approach (presented this year at monthly webinars by ISPE C&Q CoP) and focuses on the capstone transition from a traditional to a science / risk-based approach.
1345 – 1415
Sustainability & Supply Chain Resiliency
J&J is committed to improving sustainability. Recognizing the importance of sustainability in the construction industry, we started a challenging initiative in 2023, focusing on embodied carbon emissions in our construction projects (LCA). 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 with 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, created generic guidelines on how to implement embodied carbon reduction strategies into our future construction projects and aligned on a standard for measurement. In 2024 we embarked upon disseminating these insights to our global Project Delivery and Engineering team, ensuring that this knowledge becomes embedded in our organization. Additionally, we incorporated LCA into our sustainable design policy to drive sustainable practices across our entire (future) building portfolio. This way we put our corporate’s sustainability ambitions into practice in our facilities.
1345 – 1415
Manufacturing - Quality Control & Operational Excellence
Jason Schneider, AbbVie Inc
Robert Perks, Performance Validation, Inc.
As the biopharma and medical device industries embrace Pharma 4.0TM and Artificial Intelligence and acknowledge their necessity as competitive advantages in an increasingly competitive environment, there are still many fundamentals that are overlooked in the successful deployment of these applications. This presentation will examine the practical requirements for the successful deployment of Pharma 4.0TM and Artificial Intelligence into the manufacturing environment. The presentation will include real-world examples that demonstrate the holistic approach necessary to ensure both successful and sustainable deployment of applications and initiatives that provide real solutions to problems. The understanding of the problem that is being addressed, the workforce requirements, and preparation are as important, if not more so, than the technology being deployed. The presentation will also guide the audience through the steps required to not only ensure a successful outcome but to also provide a framework that can be defended at an audit. Understanding the problem, determining the business value and ROI, AI data readiness, testing strategies, maintenance and monitoring, and, ultimately, audit readiness.
1415 – 1445
Digital Transformation
Rod Hoffman, AstraZeneca
Giuseppe Menin, Ing. Punzenberger COPA-DATA GmbH
Modular plant projects for the process industry are currently not only being discussed in academia but also tested in industrial applications. These innovative plants are designed to provide flexibility that allows manufacturers to quickly respond to changing market conditions. Conventional large-scale, custom-built, single or multi-product plants no longer seem suitable for addressing strategic challenges such as reduced product lifecycles, increasing product differentiation, and heightened competitive pressures in highly volatile markets. Modular plants with a high degree of flexibility pose various challenges for those involved in automation and digitalization. Traditional approaches using hierarchical and monolithic architectures are not suitable for modular approaches. A concrete response to these needs is represented by the MTP (Module Type Package VDI/VDE/NAMUR 2658) standard originally developed by NAMUR now on the way to becoming an international standard IEC 63280. MTP4ISPE working group, part of the "Plug & Produce" initiative within ISPE Pharma 4.0's Community of Practice (CoP), aims to analyze and evaluate MTP applicability within pharmaceuticals. This contribution intends to publicly present the content of a new ISPE concept paper about the digitalization of Modular Plants according to MTP resulting from contributions made by experts from life sciences involved in the digitalization of manufacturing lines.
1415 – 1445
Manufacturing - Quality Control & Operational Excellence
Matthew Foster, Eli Lilly
As a greenfield site, Lilly RTP (Research Triangle Park) is the first flagship of Lilly’s facility modernization investment to meet a growth period of new innovative medicines and rapid demand. Lilly RTP was designed first with speed and innovation at the forefront. It includes the most modern aseptic filling and inspection technology, high-speed device assembly and packaging, and automatic material movement. The facility was designed with a digital-first mandate as a 100% paperless plant; this includes fully integrated electronic batch records integrating all material operations, and a suite of digital integrated tools to oversee all plant operations. From dock to dock, there is no manual handling; materials are moved by automatic conveyance, robotic palletization, and automatic guided vehicles which exactly pick and place all material movements directly to the production line. As a result of this technology integration, Lilly RTP was able to ramp quickly and achieve a high-volume reliable supply of medicines. This technology integration has quickly demonstrated value through improved safety, human error reduction, and productivity.
1415 – 1445
Advanced Therapy Medicinal Products (ATMPs)
John Hatzis, Rockwell Automation - Marlboro MA
Steve Chapman, Barry-Wehmiller Design Group
ATMPs (advanced medicinal products) have undergone an impressive journey over the last years, from successful solutions developed in a scientific environment to a substantial part of the pharma industry, promising cures to patients with a previous lack of treatment possibilities. And yet, the complexity of the manufacturing process, combined with the variability of starting material and lack of continuous process verification methods, has raised questions from health care, regulatory agencies, and therapeutic developers alike, on possibilities to improve understanding, control, and finally optimization of the ATMP process. The CoP on digitization of ATMPs is collaborating on suggestions to solve these issues by digital enablement of data, and developing best practices for data collection, contextualization, storage, and usage. The pharmaceutical and life sciences industries have recognized artificial intelligence (AI) and machine learning (ML) as pivotal tools for improving process control, verification, and optimization. However, the journey towards full adoption of these technologies can be overwhelming, often leading to an "all-or-nothing" mindset. This presentation offers a practical roadmap for the gradual integration of AI/ML into existing frameworks, taking into consideration the specific needs and complexities of different business models.
1415 – 1445
Regulatory - Compliance & Quality
Steven Wisniewski
ASTM E2500: Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach was approved in 2007. It defined the requirements for the application of a QRM Process for C&Q that applied to all elements of pharmaceutical and biopharmaceutical manufacturing systems including good GMP utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and/or patient safety. An update of the Standard was needed to reflect new and changed ICH Guidance (Q8/Q9/Q10), Regulatory Guidance such as FDA PV and EU Annex 15, ISPE and PDA Guidance Documents, and current industry practices. This presentation will present the major changes and additions in the revised Standard and discuss supporting rationales considered by the draft team. Example areas addressed include requirements definition, QRM and risk assessment, responsibilities and system owner, QbD for process controls, the C&Q Deliver Process, acceptance criteria, and C&Q process enablers.
1445 – 1515
Manufacturing - Quality Control & Operational Excellence
Philippe Cini, PhD, A-connect
In this presentation, the author will introduce a systematic, practical, and fast methodology to achieve quantitative process understanding and control using primarily sparse historical data from either development or commercial manufacturing. Through recent case studies, the author will show how, in one instance, this approach that combines advanced modeling and expert knowledge successfully addressed late-stage development process deficiencies and in another instance led to the elimination of stability issues in a very complex investigation of a commercial product. The author will make the case to use historical data for modeling even when those datasets are incomplete and highly not normal. The insight created can be quite powerful and it is a lot faster and cheaper than generating new data. Generating new data should be a last resort or rather used in a focused way to verify/confirm the findings achieved through mining and analysis of historical data. The author will also share how those innovative data-driven approaches can benefit greatly from today's digital capabilities to further enhance them and make them more readily applicable.
1445 – 1515
Regulatory - Compliance & Quality
Matt Oremland, PhD, Redica Systems
Rose Mary Aversa, ProQuality Network
As the demand for customized medications grows, outsourcing facilities must strengthen manufacturing capabilities to meet regulatory expectations. In response, the FDA introduced Compliance Program 7356.040 for Outsourcing Facility Inspection, a framework to ensure regulatory adherence and product safety. Published on January 15, 2025, this program plays a crucial role in safeguarding public health by guiding FDA investigators in assessing outsourcing facilities. By enforcing these standards, the FDA aims to prevent product defects, contamination, and safety risks. Pharmaceutical companies must implement and sustain compliance measures to avoid regulatory penalties, product recalls, and reputational harm. This session will provide an understanding of Compliance Program 7356.040 and its role in strengthening outsourcing facility cGMP requirements. Through interactive discussions and case studies, participants will explore strategies for building a sustainable, lean Quality Management System (QMS) that enhances operational efficiency and supports growth. Attendees will engage in polling activities and scenario-based discussions, gaining insights into best practices. By the end, participants will leave with actionable takeaways, including a QMS framework and networking opportunities for real-world implementation. Whether developing a new QMS or refining compliance strategies, this session will equip you with the knowledge and tools to build a robust and compliant QMS in pharmaceutical settings.
1445 – 1515
Digital Transformation
Philipp Bayer, Rommelag ILabs GmbH
Digital transformation in Pharma 4.0 promises reduced downtime, enhanced product quality, improved regulatory compliance, and significant cost savings through a connected, data-driven ecosystem. Data is the strategic resource powering this revolution, with advanced equipment serving as its primary engine: A robust data architecture begins with precise PLC software design and intuitive Human Machine Interface (HMI) development, ensuring accurate, real-time capture from the shop floor. Comprehensive information modeling—incorporating metadata and adhering to evolving industry standards like OPC UA—facilitates seamless integration across systems. Equipment designed for Pharma 4.0 must feature interfaces that connect with central systems such as Manufacturing Execution Systems (MES) and employ secure technologies to deliver data to less secure networks, including office environments and cloud platforms. This talk explores how transforming the data and interface architecture of production equipment creates the backbone of Pharma 4.0 and modern smart factory integration. It traces the journey from tailored equipment design to a standardized product approach that enables digital solutions: Digital Twins for staging and integration, transactional communication for MES connectivity, and secure live data delivery for real-time monitoring and AI-driven predictive maintenance.
1445 – 1515
Sustainability & Supply Chain Resiliency
Aoife Kelly, Arcadis
Alan Keogh, Cool Planet
Every pharmaceutical site relies heavily on data, from building management systems monitoring operations to production figures influencing financial decisions. Interpreting this data is critical to measuring real-time energy consumption, identifying opportunities to reduce or reuse energy, and lowering greenhouse gas (GHG) emissions. Adding to the complexity, this data must be translated into actionable financial insights when seeking capital investment. In this presentation, we will highlight a case study of a pharmaceutical facility where a $10 million CAPEX investment led to a 67% reduction in Scope 1 emissions within a year, delivering over $1 million in annual OPEX savings. A comprehensive site-wide audit was conducted, moving “behind the meter” to provide the client’s engineering team with a detailed breakdown of energy usage by form and the corresponding GHG emissions across all systems. This process generated a series of opportunities, prioritized based on corporate and site sustainability targets, CAPEX, OPEX, and ROI. Due to the success of this project, the model has been replicated across three more sites, driving cultural change throughout its global operations—from the plant room to the boardroom. In this session, we aim to share our experiences from a designer's perspective including the challenges, successes, and lessons learned.
1445 – 1515
Advanced Therapy Medicinal Products (ATMPs)
Xavier De Mollerat Du Jeu, Legend Biotech
1515 – 1615
1615 – 1645
Digital Transformation
Markus Adlberger, Körber Pharma Inspection GmbH
Steffen Münzer, Johnson & Johnson Innovative Medicine
In today’s competitive landscape, an important factor in drug manufacturing is improving both machine efficiency and uptime. However, time for testing process optimizations on the machine is limited and costly in a running production process. A digital twin for creating and testing visual inspection recipes minimizes machine downtime and offers a significant productivity boost. By utilizing data collected during production, inspection processes can be optimized and tested in a virtual environment, which accelerates development cycles and lowers operational costs. In a collaborative speech, Körber Pharma Inspection and Cilag will present how leveraging the benefits of a digital vision twin can ensure a more cost-effective, agile, and resilient inspection process.
1615 – 1645
Regulatory - Compliance & Quality
Jennifer Brown, Pfizer
Lina Niu, Pfizer
Many currently approved products have long-term stability data at 25°C/60% RH and accelerated data at 40°C/75% RH conditions, intended to support Zone II markets. As part of the Accord for a Healthier World program, Pfizer seeks to bring our full portfolio of patented and off-patent medicines to 45 lower-income countries as part of an initiative to reduce healthcare inequalities. However, many of these countries are classified as Zone IV and thus are not supported by the available stability data, making filing in these markets a challenge. A novel approach to stability is presented to support filing in these markets without the need, or commitment, to generate any additional stability data.
1615 – 1745
Advanced Therapy Medicinal Products (ATMPs)
Benjamin Espen, Avobis Bio, LLC
Blair McNeill, Sumitomo Pharma America, Inc.
Samarenda Mohanty, Nanoscope Therapeutics Inc.
The Future of CGT: Innovations in Decentralized Clinical Trials and Technological Advancements
NOTE: This session is 90 minutes
The landscape of clinical trials in cell and gene therapy (CGT) is evolving rapidly, driven by the need for more patient-centric, efficient, and scalable approaches. Decentralized clinical trials (DCTs) are emerging as a game-changer, leveraging cutting-edge technologies to streamline patient recruitment, enhance data collection, and ensure regulatory compliance. This panel brings together experts from quality and regulatory affairs, biotech leadership, scientific innovation, and digital compliance to explore the transformative impact of DCTs on CGT. Panelists will discuss the latest advancements in decentralized trial models, the role of AI and digital platforms in trial execution, and the regulatory considerations for ensuring quality and compliance. Attendees will gain insights into how technology-driven strategies are addressing key challenges in CGT trials, improving patient access, and accelerating drug development.
NOTE: This session is 90 minutes
The landscape of clinical trials in cell and gene therapy (CGT) is evolving rapidly, driven by the need for more patient-centric, efficient, and scalable approaches. Decentralized clinical trials (DCTs) are emerging as a game-changer, leveraging cutting-edge technologies to streamline patient recruitment, enhance data collection, and ensure regulatory compliance. This panel brings together experts from quality and regulatory affairs, biotech leadership, scientific innovation, and digital compliance to explore the transformative impact of DCTs on CGT. Panelists will discuss the latest advancements in decentralized trial models, the role of AI and digital platforms in trial execution, and the regulatory considerations for ensuring quality and compliance. Attendees will gain insights into how technology-driven strategies are addressing key challenges in CGT trials, improving patient access, and accelerating drug development.
1615 – 1645
Manufacturing - Quality Control & Operational Excellence
1645 – 1715
Digital Transformation
Robert Guenard, Pfizer
Brian Eden, Capgemini
Pharmaceutical Research & Development has specific deliverables (target and lead ID, study design and execution, scaleup) and challenges in meeting these deliverables consistently (identifying and validating the right biological target, finding and optimizing a lead compound with sufficient properties, bridging the gap between animal and human models, developing reproducible, scalable production processes). Considering how NextGen Laboratory solutions help requires an assessment of these R&D challenges such that the vision of Lab transformation supports the overall vision of R&D itself. Furthermore, well-organized transformations must tie strategic goals to measurable KPIs with a mix of associated solutions, from simple, known techniques to new and innovative approaches. In this discussion, we will outline what the research indicates on the latest trends in NextGen laboratory strategy and tactics, provide an overview of the current and planned future states of Pfizer’s Smart Lab Program, and address some of the critical sponsorship and change management hurdles that need to be addressed to allow this transformation to realize its intended benefit.
1645 – 1715
Sustainability & Supply Chain Resiliency
Mike Peck, BioMarin Pharmaceutical
Miriam Monge, Sartorius Bioprocess Solutions
In this presentation we will share how the Biopharmaceutical Manufacturing Industry is evolving an approach to Supply Resilience based on lessons learned from the Pandemic, the desire of Senior Executives to focus on Supply Resilience in the post-pandemic era, and the need to develop industry-wide solutions that cover how we collaborate across the End-To-End Supply Chain to become aware of and respond to any future Crisis (not just the next Pandemic) that might impact our ability to supply biopharmaceuticals to the people that need them at country, region or global level. We will walk through a Pandemic Timeline activity undertaken in the early summer of 2023, explain how that was communicated to Industry Senior Sponsors, and how we have developed the terms of reference for a Crisis Response and Management Team. More specifically activities that underpin and support the Crisis Response & Management Team approach - such as pre-qualification of suppliers, criticality mapping (supply chain risk), Materials of Concern - Alert Process Looking to the future we are engaging effective Stakeholder engagement across Agencies and external organizations such as BARDA, HERA, FDA, EMA to develop a Supply Resilience Ethos across the End to End Supply Chain.
1645 – 1715
Regulatory - Compliance & Quality
Eli Zavialov, GlaxoSmithKline
As global regulatory agencies work to streamline post-approval change approvals, reliance mechanisms, and ICH Q12 have emerged as complementary solutions. This session explores how reliance—through mutual recognition agreements (MRAs), work-sharing models, and WHO Collaborative Registration Procedures—can facilitate the adoption of ICH Q12, particularly in markets that have yet to fully implement it. By leveraging reliance, regulators can reduce redundant assessments, accelerate approvals, and improve regulatory convergence. This presentation will highlight real-world examples, including how ACSS, ACCESS, and PIC/S initiatives support reliance-based post-approval changes. Key discussion points include:
How reliance supports Post-Approval Change Management Protocols (PACMPs) and Established Conditions (ECs)
Case studies of successful reliance-based post-approval change approvals
Strategies for integrating reliance into non-ICH regulatory frameworksIndustry perspectives on using reliance for global lifecycle management
While reliance offers efficiency, challenges remain in harmonizing practices and aligning regulatory expectations. This session will discuss potential solutions, including regulatory cooperation, digital tools, and capacity-building efforts. Additionally, it will explore how emerging regulatory science initiatives can further enhance reliance-based decision-making. Attendees will gain actionable insights on optimizing regulatory pathways, improving supply chain continuity, and enhancing global collaboration in the evolving pharmaceutical landscape.
How reliance supports Post-Approval Change Management Protocols (PACMPs) and Established Conditions (ECs)
Case studies of successful reliance-based post-approval change approvals
Strategies for integrating reliance into non-ICH regulatory frameworksIndustry perspectives on using reliance for global lifecycle management
While reliance offers efficiency, challenges remain in harmonizing practices and aligning regulatory expectations. This session will discuss potential solutions, including regulatory cooperation, digital tools, and capacity-building efforts. Additionally, it will explore how emerging regulatory science initiatives can further enhance reliance-based decision-making. Attendees will gain actionable insights on optimizing regulatory pathways, improving supply chain continuity, and enhancing global collaboration in the evolving pharmaceutical landscape.
1645 – 1715
Manufacturing - Quality Control & Operational Excellence
Erwan Levesque, Sanofi
Explain how Engineering, at the global and site level within Sanofi Manufacturing & Supply, is embracing a new operating model at scale in facilities management, asset management, automation, and project delivery with the leveraging of the size & footprint of the company, new technologies, new way of working and ecosystem. Explain as well how we will use this opportunity to work as collective intelligence within engineering & maintenance teams and associated internal and external stakeholders. Explain as well how we design an organization supporting talent density/development and fluid transitions (both ways) between sites, regions, and global or large project management positions.
1715 – 1745
Digital Transformation
Alan Bateman, Johnson & Johnson Innovative Medicines
Yvonne Duckworth, CRB
Pharma’s digital transformation is no longer a question of "if" but "how fast" - yet securing buy-in, funding, and stakeholder alignment remains a challenge. Digital Maturity Assessments are proving to be a game-changer, offering a standardized, data-driven approach to measure readiness, justify investments, and drive enterprise-wide digital strategies for brownfield and greenfield facilities. In this engaging and dynamic panel discussion, leaders from J&J and FUJIFILM, along with Digital Technology SMEs, will share how they’ve leveraged Digital Maturity Assessments to break down silos, gain executive support, and move beyond scattered digital initiatives to cohesive, high-impact transformation efforts that provide concrete value as well as a strong foundation for their Digital Transformation initiative. This session will also actively involve the audience, encouraging interactive discussions and fostering a collaborative exchange of ideas. Join us to gain actionable insights on using Digital Maturity Assessments as a strategic catalyst to see your digital transformation to fruition.
1715 – 1745
Sustainability & Supply Chain Resiliency
Melanee Short, Sanofi
Sanofi has committed to aggressive targets and programs to reduce our Environmental footprint. Planet Care focuses on 5 main pillars: Carbon, Water, Biodiversity, Ecodesign, and Waste. The Global Engineering team is responsible for identifying and executing many of the projects across our Manufacturing and Supply sites that will allow us to achieve our Planet Care goals. Although we have made great strides in our energy efficiency program (reducing consumption by close to 10% since 2021), one of our challenges is continuing to raise the visibility and prioritization of projects to achieve our energy and carbon targets. In 2024 we were given the opportunity to join the McLaren partnership initiative to support the execution of our energy program and boost the overall awareness of this important initiative. Through this partnership, Sanofi has been able to "gamify" our Energy Efficiency program and build a competitive spirit that drives performance. We have onboarded our top 10 energy-consuming sites in a competitive race where we compete to see who is achieving our KPIs and then following the race provide the space to interact and share best practices. My presentation will describe our journey with McLaren and the results we have experienced to date.
1715 – 1745
Regulatory - Compliance & Quality
Afrah Mujeeb, Access Vascular Inc
Artificial Intelligence (AI) and Machine Learning (ML) are transforming regulatory decision-making by enhancing compliance monitoring, risk assessment, and regulatory submissions. As agencies such as the FDA, EMA, and ICH develop frameworks for AI integration, challenges in model validation, data integrity, bias mitigation, and transparency must be addressed. This session will explore how AI/ML is shaping regulatory intelligence, clinical trial optimization, and pharmacovigilance, while examining key regulatory initiatives, including FDA’s AI/ML Action Plan, EMA’s AI Reflection Paper, and ICH’s harmonization efforts. Case studies will illustrate the successful application of AI in regulatory workflows. Attendees will gain insights into best practices for AI model validation, explainability, and compliance with evolving global regulations. The discussion will provide actionable strategies for ensuring AI-driven decision-making aligns with Good Machine Learning Practices (GMLP), GxP requirements, and ethical considerations, enabling regulatory professionals to navigate the complexities of AI adoption in a highly regulated environment.
1715 – 1745
Manufacturing - Quality Control & Operational Excellence
Sajida Roberson, Independent Consultant
The pharmaceutical industry is growing more complex, requiring agile, data-driven operations to maintain efficiency and quality. To remain competitive, companies must simplify how they manage internal and external ecosystems while upskilling their workforce to meet evolving industry demands. Astellas Pharma has expanded rapidly through strategic acquisitions and investments in cutting-edge research and manufacturing hubs. This growth led to fragmented processes, inconsistent requirements, and operational complexity. It also underscored the need for talent with expertise in supply chain management, provider partnerships, and operations across both small molecules and advanced modalities. To address these challenges, Astellas implemented the Strategic Outsourcing and Relationships (SOAR) Model—an operating framework that simplifies operations, strengthens provider partnerships, and builds leadership capabilities while improving efficiency. SOAR integrates center-led coordination with localized execution, optimizing provider relationships, upskilling talent, and driving operational excellence. This session explores SOAR’s scalable framework that is a catalyst for operational transformation and how at Astellas it:
- Developed leaders with critical supply chain and operational expertise- Enhanced organization agility, strengthened resiliency, and fostered change readiness
- Aligned research and early-stage manufacturing strategy with operational realities post-acquisition
- Optimized provider partnerships to improve efficiency, quality, and compliance- Simplified requirements and reduced administrative burdens.
- Developed leaders with critical supply chain and operational expertise- Enhanced organization agility, strengthened resiliency, and fostered change readiness
- Aligned research and early-stage manufacturing strategy with operational realities post-acquisition
- Optimized provider partnerships to improve efficiency, quality, and compliance- Simplified requirements and reduced administrative burdens.
1745 – 1915
1930 – 2200
A Walk in Their Shoes: Legends, Leadership & the Ones Who Paved the Way.
This Event Requires Separate Registration and Fee – Space Is Limited!
We’re back—and this time, we’re walking in the footsteps of legends. After a year of anticipation, Women in Pharma’s signature Monday Night Networking Event returns with a bold new twist. Set against the moody backdrop of a swanky off-site jazz club, this immersive evening blends Old Hollywood elegance with purposeful storytelling to honor the pioneers—women and allies—who helped shape the pharmaceutical industry. This isn’t just a networking event. It’s a guided experience. Step into the shoes of the trailblazers who came before us. Through curated stories, conversation prompts, and collaborative table activities, you’ll connect more deeply—not just with other attendees, but with the history and future of women in pharma. Think vintage glamour, jazz in the air, and stories that stir your soul.
0700 – 0800
0700 – 1800
0800 – 0810
General Session
0810 – 0820
General Session
0820 – 0850
As the pharmaceutical industry continues to evolve, so must our approach to quality. In this keynote, Elaine Shannon, Global Quality Officer at Takeda, will share how the company is reimagining quality across its operations — shifting from traditional structures to a more sustainable, agile, and digitally enabled model. The pharmaceutical industry’s transformation into the digital era brings an unprecedented blend of challenges and opportunities for quality and manufacturing. Digital transformation offers immense potential to reshape how Quality organizations operate, empowering teams, enhancing transparency, and improving speed to patient. Advanced technologies and data analytics are redefining processes, allowing for more efficient risk management, predictive quality, greater transparency and enhanced regulatory compliance. Along with these opportunities come challenges such as data integrity, talent readiness, and the alignment of traditional quality systems with modern digital frameworks. Elaine will discuss how organizational and digital change are coming together to strengthen quality systems, how the company is investing in upskilling its people, building digital fluency while remaining rooted in Takeda’s enduring values. Attendees will leave with insights into what it takes to lead large-scale transformation in a complex, global environment—and why quality remains at the heart of it all.
0850 – 0920
General Session
0920 – 0930
0930 – 1030
0930 – 1545
1030 – 1100
Manufacturing - Quality Control & Operational Excellence
Paul Lopolito, Steris Corporation
Equipment cleaning concerns are often overlooked during the design, startup, and commissioning of biopharmaceutical facilities. Failures to understand cleaning agent selection, critical cleaning parameters, drug product degradation, analytical method recovery factors, and stainless-steel maintenance strategy can lead to costly delays in the process. Technical transfer teams and regulatory agencies expect laboratory testing to support the cleaning validation lifecycle approach. This presentation will explore a case study incorporating routine cleaning evaluation, air-liquid interface residue cleaning strategy, total organic carbon recovery, drug product degradation, and stainless-steel maintenance testing. The samples evaluated included drug products, inorganic buffers, organic buffers, and media. This valuable information obtained during the design transfer stage enabled the manufacturing process team to focus on the later stages of cleaning qualification and monitoring.
1030 – 1100
Advanced Therapy Medicinal Products (ATMPs)
Stephen Judd, CEng, FICHemE, FIEI, Arcadis
Robert Buccino, Bristol Myers Squibb
Jorge Linares, Bristol-Myers Squibb
Personalized therapies are changing the face of cancer treatment. Autologous CAR-T cell therapy involves genetically modifying the patient’s own cells, to give their immune system the tools to effectively fight off the cancer, potentially with a single treatment. With advancements in process technology, there is now a shift from “speed to market at all costs” toward process optimization and manufacturing efficiency. This is the story of the Bristol Myers Squibb EU Cell Therapy Facility, Project Triton. This state-of-the-art facility was designed as a highly flexible multiproduct CAR-T manufacturing facility and overcame the challenges of being designed during the COVID lockdowns to be brought to realization. This presentation shall also outline how Discrete Event Simulation (DES) software was used to optimize the equipment requirements and ensure the most efficient use of space. The two CAR-T therapies that shall initially be produced at the facility were amongst the first to be licensed and are based on cutting-edge technology at that point in time. This agile and flexible facility has been designed with an efficient use of space and one eye on the future to ensure advancements in process technology such as integrated manufacturing platforms, can be easily implemented.
1030 – 1100
Regulatory - Compliance & Quality
Nicholas Rattenni, Epista Inc.
The session will focus on the vision for a global dossier and how the convergence of requirements will reduce review timelines by encouraging collaboration across regulatory authorities and reducing duplicate effort and complexity of questions. The main themes include:
- A practical vision for a global dossier and what steps the industry can take now to progress this regionally and globally.
- A descriptive breakdown of the eCTD and relevant data standards (ICH, ISO, regional requirements). Exploring which content is prime for digitalization, which content will remain text-based, and the challenges for data-centric submissions.
- Current global initiatives/guidance supporting convergence of regulatory requirements and global collaboration (Reliance, Orbis, Access Consortium, African Medicines Agency, ICRMA, ICH M11, and others). What are the differences and overlaps?
-Impact to industry: what are the complexities required to support a core dossier approach and a successful regulatory strategy for an organization? Complexities include: strategic assessment of requirements, structured data and data quality, data ontologies, regulator agreements, language and translations, technical infrastructure, collaboration processes, technical security, etc.
- Case study example from industry leaders who are conducting pilots and studies focused on core dossier submissions and collaboration amongst regulatory authorities.
- A practical vision for a global dossier and what steps the industry can take now to progress this regionally and globally.
- A descriptive breakdown of the eCTD and relevant data standards (ICH, ISO, regional requirements). Exploring which content is prime for digitalization, which content will remain text-based, and the challenges for data-centric submissions.
- Current global initiatives/guidance supporting convergence of regulatory requirements and global collaboration (Reliance, Orbis, Access Consortium, African Medicines Agency, ICRMA, ICH M11, and others). What are the differences and overlaps?
-Impact to industry: what are the complexities required to support a core dossier approach and a successful regulatory strategy for an organization? Complexities include: strategic assessment of requirements, structured data and data quality, data ontologies, regulator agreements, language and translations, technical infrastructure, collaboration processes, technical security, etc.
- Case study example from industry leaders who are conducting pilots and studies focused on core dossier submissions and collaboration amongst regulatory authorities.
1030 – 1100
Sustainability & Supply Chain Resiliency
Sean Ogle, SEI
Astellas Pharma rapidly expanded through strategic acquisitions in advanced modalities and investments in cutting-edge Research and Manufacturing Hubs. However, this rapid growth led to operational inefficiencies, inconsistent processes, limited visibility into third-party dependencies, and underutilized enterprise capabilities—hindering resilience and efficiency. To address these challenges, Astellas implemented the Strategic Outsourcing and Relationships (SOAR) Model, an operating framework that enhances governance, visibility, and risk mitigation while balancing local flexibility with centralized coordination. The SOAR Model enables digital integration, global alignment, and external collaboration across a complex, innovation-driven ecosystem. This session will explore how Astellas:
- Aligned research and early-stage manufacturing strategy with operational realities following multiple acquisitions.
- Created real-time visibility into third-party risks, supplier dependencies, and committed time horizons, improving forecasting and asset-level planning.
- Established a strategic provider pool, reduced supplier engagement from months to days, eliminated 380+ annual contracts, and delivered significant cost savings and working capital improvements.
- Strengthened governance and monitoring, enhancing coordination and resource allocation while improving compliance and agility.
Attendees will gain insights into how SOAR enables navigating a TUNA world and building supply chain resilience.
- Aligned research and early-stage manufacturing strategy with operational realities following multiple acquisitions.
- Created real-time visibility into third-party risks, supplier dependencies, and committed time horizons, improving forecasting and asset-level planning.
- Established a strategic provider pool, reduced supplier engagement from months to days, eliminated 380+ annual contracts, and delivered significant cost savings and working capital improvements.
- Strengthened governance and monitoring, enhancing coordination and resource allocation while improving compliance and agility.
Attendees will gain insights into how SOAR enables navigating a TUNA world and building supply chain resilience.
1030 – 1100
Digital Transformation
Oliver Herrmann, Q-FINITY Quality Management
Frank Henrichmann, Q-FINITY Quality Management
The role of quality assurance (QA) in IT validation projects is undergoing a fundamental change. While traditional document-based approaches often lead to a high administrative burden, the focus is increasingly shifting to a risk-based, system- and records-oriented approach. But what core competencies does QA need to add value to validation projects or to monitor them effectively? Which aspects can and should QA check in terms of content? The presentation will highlight how a future-oriented QMS for computer system validation can be designed to ensure both flexibility and regulatory compliance. Particular focus will be placed on control objectives – i.e., the actual goals of validation rather than a rigid, over-regulated documentation approach. Key questions of the presentation: What skills and knowledge are essential for QA in IT validation? Does the document-based approach still have a future, or are digital, system-based methods the new standard? How can QA meaningfully contribute to validation through a risk-based approach and critical thinking? How many standards, templates, and checklists are necessary – and when do they become a hindrance? The presentation shows practical strategies for how QA departments can use modern methods to establish an efficient, future-proof QMS for CSV.
1100 – 1130
Manufacturing - Quality Control & Operational Excellence
Josh Russell, AST, Inc.
Steven Ng, AST Inc
This technical presentation will present the development and use of 7% Vapor Phase Hydrogen Peroxide (VPHP) for decontamination in aseptic isolators and includes design considerations, validation protocols, and data points across multiple isolated filling line configurations. Effective decontamination protocols utilizing hydrogen peroxide are standard to sterility strategies but pose significant challenges to aseptic processing operations. These challenges include extended operational downtime due to application methods, and high-concentration limitations and risks. Conventional methods using high-concentration VPHP also incur risks to personnel and sensitive equipment with measurable absorption and long periods of off-gassing, which have largely been considered necessary consequences of achieving sterility assurance. Recent advancements in decontamination technology, however, have focused on process, efficiency, and safety improvements that are both regulatorily robust and consider manufacturing realities around new products like highly targeted, time-sensitive liquid pharmaceuticals. One such advancement is the use of low-concentration rapid VPHP technology for a complete 1-hour cycle time, including aeration. In this presentation, validation data will be used to evaluate the efficacy of low-concentration, low-volume VPHP in achieving >6-log reduction, mitigating outgassing (PPM over time), expanding material compatibility, and reducing machine downtime in an automated fill-finish setting.
1100 – 1130
Sustainability & Supply Chain Resiliency
Fabian Dreier, Endress+Hauser Group Services AG
In a world filled with unpredictability, the pharmaceutical industry's ability to bounce back from disruptions hinges on a resilient supply chain. This proposal explores strategies for 2025, focusing on how to prepare for unexpected events, respond quickly to disruptions, and maintain operations seamlessly. The spotlight is on Endress+Hauser’s approach, showcasing their resilience practices historically. Our long-term strategic approach will be shared as well as more recent lessons learned from Covid, Global Conflicts & the unfolding socio-political-macroeconomic events of 2025. We will also discuss the latest sustainability initiatives and the associated challenges of single-use products. Join us as we discuss the past and prepare for the future.
1100 – 1130
Regulatory - Compliance & Quality
Gregory Rullo, AstraZeneca
Using reliance and collaboration pathways by Health Authorities for the review of New Drug Applications (NDA) and CMC Post Approval Submissions has significant value in greatly accelerating global approvals. By leveraging assessments from reference regulatory authorities, reliant health authorities can expedite their review processes, reduce redundancy, and drive convergences of requirements. Additionally, Reliance allows smaller regulatory agencies to utilize the expertise of larger authorities, minimizing the need for extensive local evaluation. This presentation will discuss AstraZeneca's experience with Reliance for post-approval submissions and also share data from the experience of a cross-industry group where 104 countries participated in the use of Reliance.
1100 – 1130
Advanced Therapy Medicinal Products (ATMPs)
George Todorov, IPS
Stephen Lane, Stephen Lane
With the increasing demand for autologous and allogeneic cell therapies in the market, the ever-present bottleneck of scaling to meet the expected demand of the future is a common challenge in our industry. When faced with the complex interconnected processes and unit operation timing associated with cell therapies, the use of simulation can assist with answering what-if scenarios, outputting data estimates, and providing visualizations. This presentation will explain what simulation can offer and when it is most appropriate to use by providing an overview of several client studies conducted to address manufacturing challenges. Examples include the feasibility of production ramp-up at an existing facility and studying the manufacturing capacity of a flexible facility housing multiple therapeutic modalities. The projected production ramp-up and manufacturing capacity study examples were modeled based on existing manufacturing timing data, block flow diagrams, and facility layouts. Various scenarios were tested using simulation including the adjustment of scheduling, operational strategy changes, the number of available suites, equipment quantities, and the quantity of staff. These case studies will walk the audience through details such as evaluated areas, project approach, simulation experimentation, and study findings.
1100 – 1130
Digital Transformation
Ken Shitamoto, Gilead Sciences
Abhishek Bachchan, Gilead Sciences
As modern software engineering practices such as Agile, DevOps, and cloud computing reshape regulated industries, processes must evolve to match the pace. CSV must move beyond the status quo to become adaptive, acting as a strategic enabler of quality, efficiency, and innovation. This session will focus on transforming CSV processes through leadership strategies and collaborative approaches. Attendees will learn how to create engaging, effective CSV programs that prepare teams for modern software development realities while ensuring compliance. By rethinking CSV and aligning it with real-world software engineering principles, organizations can improve efficiency, foster collaboration between IT, Quality, and Compliance teams, and ensure CSV supports digital transformation. In today's evolving regulatory landscape and technological advancements, companies face pressure to accelerate the validation of systems supporting GxP processes while maintaining control, compliance, and costs. Traditional validation approaches create silos between IT, Quality, and Compliance teams, leading to inefficiencies, delays, and compliance risks. This session will explore how to dismantle these silos by fostering collaboration among key stakeholders for risk-based, business-driven validation strategies, illustrating real-world examples to drive a cultural shift. Attendees will gain a framework for driving efficiency, compliance, and innovation in an increasingly digital world.
1130 – 1200
Sustainability & Supply Chain Resiliency
Robin Newman, Amgen
Nina Cauchon, Amgen Inc.
Inherently, drug shortages’ root causes are simple: (1) Lack of incentives for manufacturers to produce less profitable drugs; (2) lack of market-manufacturer reward for mature quality systems focusing on continuous improvement and early detection of supply chain issues; (3) logistical and regulatory challenges that make market recovery disruption difficult. And yet, drug shortages persist in the industry, often with a systemically detrimental impact on patient access. For example, shortages in cancer treatments prevent patient entrance into clinical trials, the acquisition of clinical trial data, and the development of emerging cancer therapies. This leads to (often costly) delayed approvals from regulatory agencies. Additionally, while patients may use therapies not yet approved by regulatory agencies, such usage is deemed off-label by insurers, forcing patients of all socioeconomic statuses to bear full financial responsibility. In this presentation, I show the need for more regulatory pressure for data sharing across suppliers. I then demonstrate the need for implementing Risk Management Plans, guided by Annex 1 and ICH Q9. Lastly, I propose a model for precision in clinical trial data acquisition guidelines to change drug designation from a second-line to front-line therapy, elucidating solutions in need of attention.
1130 – 1200
Regulatory - Compliance & Quality
Companies author and maintain multiple dossier versions to support the global marketing of products largely due to varied country requirements and time-based constraints. This results in duplicative efforts and increases administrative burden. WHO defines best practices for reliance, and stringent regulatory authorities, like the EMA, consider reliance to be a valuable tool. There have been several successful reliance pilots, and there is a need for greater harmonization and adoption of a truly global dossier approach. In order to provide an end-to-end solution, a digitally generated CMC Post Approval Change (PAC) dossier was delivered to the Reference Country and nearly two dozen participating Reliance countries, simultaneously via a cloud-based platform (Accumulus). This strategy aims to redefine the regulatory landscape by accelerating global approvals while setting a new benchmark for transparency and efficiency. The digitally generated dossier was created using proprietary AI and novel Structured Content and Data Management (SCDM) software. Each jurisdiction involved has real-time access to all regulatory information, from submission details to ongoing questions, answers, and updates, as available. This approach will enable more efficient review and approval timelines, and thus speed up medicine access to patients globally. Application of these principles to innovation (ISPE-RSC priority) will also be discussed.
1130 – 1200
Manufacturing - Quality Control & Operational Excellence
Jörg Zimmermann, Vetter Pharma Fertigung GmbH & Co KG
Enhancing Sterility Assurance: Integrating Automated H2O2 Decontamination in RABS Cleanrooms
RABS and Isolators are described as appropriate technologies in Annex 1. By upgrading existing clean rooms to an automated H2O2 decontamination system, the advantages of both systems can be combined, resulting in superior sterility assurance. In this presentation, we will showcase the technical installation, qualification, and implementation of this technology in new and existing RABS clean rooms. This includes also the aspects of analytical methods to test for residual H2O2, both in the air and the filled product. Data from the last 8 successful years of operation will be shared. Attendees will get insights into the design, installation, qualification, and operation of automated decontamination of RABS clean rooms.
RABS and Isolators are described as appropriate technologies in Annex 1. By upgrading existing clean rooms to an automated H2O2 decontamination system, the advantages of both systems can be combined, resulting in superior sterility assurance. In this presentation, we will showcase the technical installation, qualification, and implementation of this technology in new and existing RABS clean rooms. This includes also the aspects of analytical methods to test for residual H2O2, both in the air and the filled product. Data from the last 8 successful years of operation will be shared. Attendees will get insights into the design, installation, qualification, and operation of automated decontamination of RABS clean rooms.
1130 – 1200
Digital Transformation
Thanabalan Subramanian, Integrity
Petch Ashida Druar, Syneos Health
The use of digital health technology (DHT) in decentralized clinical trials (DCT) comes with challenges in the areas of auditing, provisioning, and validation, while meeting regulatory expectations outlined in FDA's Conducting Clinical Trials with Decentralized Elements, FDA's Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, and EMA guideline on computerized systems and electronic data in clinical trials. In addition, ICH E6(R3) Annex 2 outlines GCP considerations for trials that incorporate decentralized elements, including data sources from DHTs. The topic expands on the recent GAMP GPG on Validation & Compliance of Computerized GCP Systems and Data, 2nd edition, and discusses alignment with regulatory guidance and practical experience in the areas of risk-based approach for technology implementation, auditing, ongoing monitoring, and third-party management.
1130 – 1200
Advanced Therapy Medicinal Products (ATMPs)
John Kenneally, Bayer
Alfred Penfold, PM Group
A study has shown that it is possible to adapt an existing mAbs drug substance facility for gene therapy production. The proposal was to use an existing mAbs facility for both mAbs and gene therapy on a campaign basis with minimal changes to the facility. The study refers to the modifications that were required to accommodate both modalities and how the facility would operate differently to accommodate gene therapy. Introducing an ATMP retrospectively in an existing mAbs facility presents a number of risks that had to be mitigated due to the additional segregation requirements needed for ATMPs. A meeting was held with the FDA to review the planned proposals, and it did not result in any major concerns.
1200 – 1415
The ISPE Membership Meeting and Awards Lunch is open to all In-Person All Access and Essentials Pass Attendees. Meet and hear from the ISPE leadership and colleagues while learning about significant achievements made by the industry in the past year. Celebrate with your peers as the ISPE International Honor Awards are presented and learn about the 2024 Facility of the Year Awards (FOYA) Category Winners & Overall Winner.
1545 – 1630
Manufacturing - Quality Control & Operational Excellence
Jeffrey Heil, Arcadis
Matthew Pelletier, Nitto Denko Avecia
Joe Laviano, PE, Arcadis
Curating a state-of-the-art manufacturing facility to meet a present demand is no easy feat – even more so is the complexity of designing and constructing a facility that needs to be equipped to thrive in a rapidly growing sector for decades to come. How can teams successfully navigate the push-and-pull of “how much do we build now to be ready to mobilize?” against the unknown of “how seamlessly can we implement future improvements to stay on the cutting edge?” 2025 FOYA Finalist Nitto Avecia, who recently completed their new M5 Facility Expansion in Milford, MA, had to weigh both sides when designing and constructing the largest oligonucleotide CDMO in the US. This panel will include team members (both engineers and end users) who were both critical to the success of the new facility and continue to spearhead initiatives that will keep the facility innovative and robust moving forward.
1545 – 1630
Advanced Therapy Medicinal Products (ATMPs)
Samarenda Mohanty, Nanoscope Therapeutics Inc.
1545 – 1630
Regulatory - Compliance & Quality
Juha Mattila, STERIS Life Sciences
Unlocking New Potential with VHP in Sterilization. This session delves into the innovative applications of Vaporized Hydrogen Peroxide (VHP) as an FDA-approved Category A sterilization modality. It explores how VHP is revolutionizing sterilization practices by offering a safe, effective, and versatile solution for various applications. Attendees will gain insights into the science behind VHP, and how it fits within the regulatory framework. Join us as we uncover the role of VHP in expanding the horizons of sterilization technology. Session DetailsThe recent move by the FDA to reclassify VHP sterilization as an Established Category A technology is a significant development for makers of single-use medical devices and packaged, prefilled syringes. The VHP-specific process validation standard, ISO 22441, was published in August 2022 and recognized in its entirety by the US FDA and many other countries. The next step in the VHP sterilization regulatory field is the publication of EN 17180 which sets requirements for VHP sterilizers with publication estimated around mid-2025. There is also a new work item started and ongoing for ISO 11138-6 which is the VHP-specific standard for biological indicators used in sterilization. Application of these principles to innovation (ISPE-RSC priority) will also be discussed.
1545 – 1630
Digital Transformation
Brandi Stockton, The Triality Group, LLC
Eric Staib, Syneos Health
The use of AI methods offers substantial potential, also in regulated areas, as evidenced by various case studies and implementations. However, with industry practices still evolving and regulatory guidance still early stage, organizations still face challenges to seize the potential of AI on scale, in lack of a harmonized and streamlined approach to managing the life cycle of an AI-enabled system and its AI sub-systems while maintaining patient safety, product quality and data integrity. To support overcoming these challenges, the GAMP® Community of Practice has produced a comprehensive guidance document, aligned and integrated with the wider GAMP landscape: “GAMP® Artificial Intelligence Guide – A Risk-Based Approach to Compliant AI-Enabled GxP Computerized Systems” (GAMP® AI Guide”). This session intends to provide an overview of the Guide’s content and key concepts, thus facilitating the dissemination and adoption of the guidance. Various points of view will be provided, including regulated organizations and suppliers, as addressees of the new Guide.
1545 – 1630
Sustainability & Supply Chain Resiliency
Cole Brunson, Flad Architects
Jaime Dwight, Promega Corporation
High-hazard manufacturing facilities pose a unique set of occupational and environmental challenges, from noise-induced risks and fall hazards to constrained equipment access and ergonomic strain from repetitive tasks. These dangers can escalate when handling high-risk materials, increasing the potential for chemical exposure or catastrophic events if not properly managed. Furthermore, the demanding nature of these environments can make it difficult to attract and retain skilled staff. This session will showcase Promega’s Chappelle Manufacturing Center as a model for how an integrated design and planning approach—combined with innovative operational solutions—can transform high-hazard facilities. Attendees will gain insights into strategies that enhance safety, optimize efficiency, and elevate the overall employee experience, ultimately fostering a healthier, more engaging, and more sustainable workplace.
1630 – 1715
Manufacturing - Quality Control & Operational Excellence
Alex Gadberry, AstraZeneca
Nicholas Guros, AstraZeneca
There is an increasingly urgent need to reduce the cost of goods and manufacturing (COGM) and to expand the manufacturing capacity of biopharmaceuticals, demonstrated by an increase in the development of new therapies concurrently with the limitations of existing fed-batch facilities. In this work, we propose a solution to this manufacturing dilemma: Integrated Dynamic Bioprocessing (IDB). Herein, we define IDB as a fully integrated, continuous, dynamic process where throughout the stages of cell growth clarified upstream material is continuously sent downstream for purification at varying titer concentrations. Note: downstream processing details are out of the scope of this work. The goal of IDB is to increase productivity over fed-batch processing (FB) by five-fold using the same bioreactor footprint and working volume. We have demonstrated this successfully at the 250 mL, 3 L, and 50 L bioreactor scales, and in this work we report the success of the 500 L clinical scale, discussing the significant scale-up challenges compared to the smaller scales. Firstly, the bioreactor was designed to sustain the required cell density (> 120 M cells/mL) to achieve this titer increase - enabling high oxygen mass transfer and mitigating the impact of the deleterious effects of cell shearing, pCO2 accumulation, foam build-up, or exhaust filter fouling. Secondly, continuous clarification was achieved using tangential flow filtration (TFF). The pilot scale required the use of numerous TFF hollow fiber filters to provide adequate surface area for filtration of the high cell density culture, ultimately requiring novel model predictive control and filter transition strategies to meet the filtration requirements of the process. Lastly, a Raman-based feeding strategy was required to dynamically respond to the glucose consumption dynamic cell culture process. Herein, we present our success in significantly increasing titer over fed-batch bioprocessing while maintaining important product quality metrics.
1630 – 1715
Sustainability & Supply Chain Resiliency
Lan Zhang, Lan Zhang, CENTURY 3 Shanghai Inc.
Cunjun Wang, Century 3 (Shanghai) Inc.
Reducing Carbon discharge is one of the important social responsibilities of corporations. During the construction, many teams took mitigation measures to reduce the carbon discharge. However, there is no quantitative method to evaluate the results by proactive method enable the team to visualize the achievement to increase the effectiveness of the initiation. At our Merck Mobius project, Mr. Feng and his team clarify the carbon-reducing targets, figure out the methodology to reduce the carbon discharge during the construction, identify the challenges of basic data, set assumptions of the data analysis and collection, periodically calculate the carbon-reducing achievement and present to the client and team so that the team has positive feedback by the method and results enable the team to increase the effectiveness of the activities to realize the commitment made by the client. The ESG best practice might be referenced by peers to present the proactive measurements taken by the team to improve our environment together with our clients.
1630 – 1715
Advanced Therapy Medicinal Products (ATMPs)
Carmen Medina, The FDA Group
This presentation discusses problems, risks, and opportunities encountered throughout the commercialization lifecycle of Advanced Therapeutics, such as cell, gene, and tissue products. Applying a Problems, Risks, and Opportunities Management Strategy (PROMS) at key milestones of product development supports the successful development, approval, launch, and sustainable commercialization of advanced therapeutic medicines. PROMS accelerates innovation and enables the successful development of transformative therapies through the implementation of early detection systems that identify and mitigate risks at key phases of the commercialization process. PROMS streamlines complex processes by providing a streamlined framework for applying meaningful and actionable metrics and safeguards throughout the development, clinical, commercialization, and post-commercialization phases. PROMS decreases the silo effect by fostering a collaborative ecosystem between the Sponsor, CROs, CDMOS, and ClinOps that accelerates therapeutic development and facilitates knowledge sharing, resource allocation, FDA support, and risk management among all stakeholders. PROMS, implemented at key commercialization milestones, supports the development of ATMPs created to address unmet medical needs and enhance the quality and duration of patient's lives.
1630 – 1715
Regulatory - Compliance & Quality
Thomas O'Donnell, Rees Scientific
Objective: This presentation explores the benefits of integrating Environmental Monitoring Systems (EMS) at the earliest stages of pharmaceutical and biotech facility design. Attendees will gain actionable insights on best practices for aligning EMS with Building Management Systems (BMS) to enhance compliance, efficiency, and operational success.
Abstract: In facility design, BMS is prioritized from the start, while EMS is often an afterthought—leading to costly retrofits, integration challenges, and compliance risks. This session will highlight the importance of early EMS planning to ensure seamless integration, regulatory alignment, and cost efficiency.
Key topics include: The Challenge of Late EMS Implementation: Retrofitting EMS increases costs, complicates system compatibility, and poses regulatory risks.
Benefits of Early EMS Integration: Ensuring seamless alignment with BMS supports compliance with FDA 21 CFR Part 11 and GMP requirements while optimizing data integrity.Collaboration in Design: Engaging architects, engineers, and vendors early streamlines facility layout, system interoperability, and long-term performance.
By embedding EMS into facility planning from the outset, companies can enhance regulatory readiness, reduce costs, and future-proof their operations for Pharma 4.0.
Abstract: In facility design, BMS is prioritized from the start, while EMS is often an afterthought—leading to costly retrofits, integration challenges, and compliance risks. This session will highlight the importance of early EMS planning to ensure seamless integration, regulatory alignment, and cost efficiency.
Key topics include: The Challenge of Late EMS Implementation: Retrofitting EMS increases costs, complicates system compatibility, and poses regulatory risks.
Benefits of Early EMS Integration: Ensuring seamless alignment with BMS supports compliance with FDA 21 CFR Part 11 and GMP requirements while optimizing data integrity.Collaboration in Design: Engaging architects, engineers, and vendors early streamlines facility layout, system interoperability, and long-term performance.
By embedding EMS into facility planning from the outset, companies can enhance regulatory readiness, reduce costs, and future-proof their operations for Pharma 4.0.
1630 – 1715
Digital Transformation
Scaling AI beyond a pilot requires more than just a successful proof-of-concept—it demands a structured approach to both technical integration and human adoption. This session presents a real-world case study on deploying AI at scale, blending control strategy development with an AI adoption playbook to ensure both technical reliability and workforce engagement.
Key topics include:
Identifying and addressing technical hurdles—ensuring AI-generated outputs are reliable, explainable, and aligned with operational needs.
Developing a control strategy to manage AI decision-making, ensuring compliance, transparency, and trust.
Navigating workforce adoption—how process changes impact teams and what strategies drive engagement.
Building the AI adoption playbook—a structured approach to onboarding, training, and sustaining AI-powered workflows.
Scaling from pilot to enterprise in 90 days—what worked, what didn’t, and key lessons for future implementations.
Rather than another AI concept discussion, this session provides practical, actionable insights from a real deployment—offering attendees a proven framework to bridge the gap between technical success and organizational adoption.
Key topics include:
Identifying and addressing technical hurdles—ensuring AI-generated outputs are reliable, explainable, and aligned with operational needs.
Developing a control strategy to manage AI decision-making, ensuring compliance, transparency, and trust.
Navigating workforce adoption—how process changes impact teams and what strategies drive engagement.
Building the AI adoption playbook—a structured approach to onboarding, training, and sustaining AI-powered workflows.
Scaling from pilot to enterprise in 90 days—what worked, what didn’t, and key lessons for future implementations.
Rather than another AI concept discussion, this session provides practical, actionable insights from a real deployment—offering attendees a proven framework to bridge the gap between technical success and organizational adoption.
1900 – 2200
0800 – 0900
0800 – 1300
0910 – 0940
General Session
0940 – 1010
General Session
1010 – 1030
1030 – 1200
General Session
1200 – 1230
General Session
1230 – 1240
General Session
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.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.