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.
Filters
Sun, 18 Oct
Mon, 19 Oct
Tue, 20 Oct
Wed, 21 Oct
0700 – 1800
0800 – 1300
Day 2 of the ISPE Hackathon builds on the momentum from Day 1 as teams arrive early to prepare for their final presentations. Teams will continue collaborating with support from the Hackathon Coaches. Once final solutions are submitted, each team will present to a panel of judges who will select the team with the winning solution.
1300 – 1600
Interactive Workshops
Jahanvi Miller, JahvanMed Advisors
Edoardo Tavazza, PQE Group
Dori Gonzalez-Acevedo, ProcellaRX
Marla Phillips, Pathway for Patient Health LLC
Professional Development | Personal Development| Social Impact, this year’s WIP Workshop during the 2026 Annual Meeting is centered around The Future of Pharma: Agility, Growth, & Continuous Improvement Strategies to navigate in a rapidly evolving industry and staying ahead. Join former US Food and Drug Administration (US FDA) regulators, industry leaders, quality experts, and emerging leaders as they share their real-world improvement strategies and gain knowledge and operational skills to thrive and have a positive impact in our industry for the future. Participants will not only gain valuable insights, but also engage in a breakout session which builds on best practices that go beyond compliance.
1300 – 1600
Interactive Workshops
Maria Amaya, PhD, Genentech, A Member of the Roche Group
Celeste Frankenfeld Lamm, PhD, Merck & Co Inc
Line Lundsberg-Nielsen, Novo Nordisk
This 3-hour interactive workshop brings together industry leaders and regulators to explore the transition from individual manufacturing sites to standardized manufacturing networks (SMNs) that enable agile scale-out, rapid tech transfer, and resilient supply. Through short, case-based presentations from Novo Nordisk, Roche, Merck, and FUJIFILM BIOTECHNOLOGIES, the session highlights different approaches to standardization, incl modulation, copy-paste, sister-sites, fleet-based operations, and operating philosophies like kojoX while maintaining consistent quality and GMP compliance across locations. It addresses the need to develop a new regulatory framework for these global networks. Regulatory perspectives (to be invited) from FDA, EMA, MHRA, and others will discuss expectations for advanced manufacturing models that support a high level of standardization, such as distributed and decentralised manufacturing, including oversight concepts for maintaining the standards across sites. Participants will then work in facilitated breakouts to co-develop approaches for SMN control strategies, digital enablers, knowledge management, and pathways for faster facility and post-approval change and approvals across the SMN (including ICH Q12 tools). The workshop concludes with practical options and next steps to help design, operate, and regulate global Standardized Manufacturing Networks.
1300 – 1600
Interactive Workshops
Mitch Cook, PhD, Deloitte
Krista McGuire, PhD, Pfizer
Jennifer Aurandt-Pilgrim, PhD, Marquis Energy
Sustainable by Design engineers and directors must often navigate substantial internal operational complexity and external market uncertainty in their efforts to seamlessly integrate low or negative emission GMP and non-GMP-regulated raw materials with manufacturing and supply chain operations. AI/ML applications and other data-driven approaches are increasingly available to reduce that complexity and increase speed-to-value from sourcing more sustainable raw materials across the product lifecycle. The objective of this workshop is to enable participants to learn about and leverage AI/ML capabilities, product lifecycle data, and market intelligence to develop and manage a joint sustainable sourcing and manufacturing project pipeline that optimizes cost efficiency, emissions reduction, and supply resilience. Participants will learn data-driven approaches to collaborate and influence relevant category strategy and transactions in service of Sustainability by Design goals for manufacturing and lifecycle management. Participants will also learn how upstream commodity suppliers that are innovating with low and negative emission raw materials drive Sustainable by Design in their own operations and design mechanisms to share those benefits through commercial supply relationships with the pharmaceutical industry. The workshop is designed for directors, managers/supervisors, and emerging leaders involved in Sustainable by Design in manufacturing, supply chain sustainability, digital transformation, and sustainability data.
1300 – 1600
Interactive Workshops
Mark Muench, AbbVie, Inc.
Step into a highly interactive workshop designed for leaders shaping the next generation of contamination-controlled facilities. This session explores how Annex 1 expectations can be transformed from regulatory challenges into powerful design opportunities. Through dynamic case studies and expert led discussions, participants will learn how to embed proactive CCS principles, holistic risk assessments, and smart design decisions directly into new facilities and major upgrades. We’ll examine real-world examples of optimized process flows, HVAC and barrier technology strategies, integrated monitoring systems, and sustainable air handling solutions that reduce contamination risk while improving efficiency and environmental performance. The workshop also breaks down common regulatory observations—highlighting where organizations struggle with CCS integration, QRM misuse, and environmental monitoring gaps—and provides actionable guidance on how to avoid these pitfalls through thoughtful, Annex 1–aligned design.
1600 – 1800
1900 – 2230
Join ISPE to celebrate the 2026 ISPE FOYA Banquet & Awards Celebration where we will formally recognize and celebrate the 2026 Category Winners' achievements. Please note that separate registration is required.
0600 – 0730
For the last time, join us for 17th Annual ISPE 5K Run/Walk being held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $100 is required to participate. This will be the last 5K Run/Walk, so be sure to sign up!
Registrants must collect their bibs and t-shirts at the Information Desk onsite prior to Monday morning.
Registrants must collect their bibs and t-shirts at the Information Desk onsite prior to Monday morning.
0700 – 1800
0700 – 0800
0800 – 0815
0815 – 0825
0825 – 0855
General Session
0855 – 0925
In this moving and actionable presentation, Jamie reveals the three essential elements required to live above your circumstances and achieve the extraordinary. Jamie bridges the gap between her father's "Never Give Up" philosophy and her own twenty-one-year journey through health crises and personal triumphs, teaching audiences how to turn their challenges into a legacy of significance.
0925 – 0930
General Session
0930 – 1030
0930 – 1900
1030 – 1200
People - Capability - Workforce of Delivery
1030 – 1100
Systems That Deliver Reliably
Hamid Teimourian, AstraZeneca
Allyssa Wilcox, AstraZeneca
Alex Mason, AstraZeneca
This presentation reviews AstraZeneca’s Ambition Zero Carbon strategy implementation at its largest global biologics manufacturing site in Frederick, MD, and shares the site’s 2015-2025 journey across energy, GHG, water, and waste. The site has undergone significant growth since 2015 (over a 600% increase in production) while reaching the carbon zero milestone by reducing its Scope 1 and 2 emissions by 98% from the 2015 baseline. We will discuss our corporate strategy and how we executed it through a decade-long program at the site level. We will also review how we are working toward the next major milestones of reducing Scope 3 emissions by engaging our suppliers, optimizing material choices, and improving logistics, while protecting product quality and supply reliability.
1030 – 1100
Governance - Risk - Readiness
Loganathan Kumarasamy, Zifo Technologies
Arif Azad, PhD, Pfizer
This presentation will explore real-time Artificial Intelligence (AI)–driven solutions that are being successfully implemented within pharmaceutical manufacturing environments. It will highlight practical use cases such as AI-enabled Periodic Reviews, automated GxP documentation generation, and intelligent batch record review systems that enhance efficiency, accuracy, and compliance. By leveraging AI, organizations are able to significantly reduce manual effort, improve data integrity, and accelerate decision-making processes across regulated operations. In addition to real-time use cases, the session will focus on the critical aspect of risk management when deploying AI solutions within cGMP-regulated environments. As regulatory expectations evolve to address advanced AI technologies in the GxP space, ensuring compliance becomes increasingly complex. The speaker will provide insights into identifying, assessing, and mitigating risks associated with AI implementation, including data integrity concerns, model bias, lack of transparency, and ethical considerations. A key emphasis will be placed on the fact that risk management for AI is often underestimated during both implementation and ongoing monitoring phases. Failure to address these risks effectively can lead to significant consequences, including compromised product quality and regulatory non-compliance. Attendees will gain a clear understanding of best practices to ensure responsible, compliant, and sustainable adoption of AI in pharmaceutical manufacturing.
1030 – 1100
Digital - Data - Decision Integrity
Frank Henrichmann, Q-FINITY Quality Management
The session will explore how artificial intelligence technologies—particularly large language models, machine learning-driven analytics, and generative AI tools—can be integrated into the end-to-end lifecycle of computerized system validation (CSV) aligned with GAMP 5 Second Edition and CSA principles in regulated life science environments. Building on the insights from the ISPE Magazine article “How AI Will Transform Computerized System Validation,” the talk will move beyond vision and theory to explore what is possible already today to increase efficiency, quality, and compliance of computerized systems. The session draws on real-world implementation experience with purpose-built digital validation platforms. How can AI support, for example:
- Requirement gathering, assessment & mapping
- Automated test-case generation
- Test execution & evidence capture
- Auto-generation of traceability matrices
- Risk-based validation planning aligned with GAMP 5 Second Edition critical thinking principles
1030 – 1100
From Breakthrough to Bedside
Jihye Nam, Astellas
Tracie Fradet, Astellas
Next-generation Sequencing (NGS) is rapidly emerging as the preferred virus detection approach because it offers broad, unbiased detection of known and novel adventitious agents, overcoming limitations of traditional assays and enabling earlier and more confident risk mitigation in cell, gene, and biologic modalities. This session provides an overview of NGS for virus detection, highlights how participation in industry consortia supports alignment on best practices, and presents a practical Regulatory CMC strategy for implementing NGS-based adventitious agent detection (AAD) in GMP programs, with emphasis on early, structured interactions with global health authorities. This session aligns with the ISPE publication 'Enabling Pharmaceutical Innovation: A report on the barriers to innovation survey (April 2024)' as it will focus on innovative method enabling using real examples of FDA and PMDA consultation pathways, the talk outlines how to align upfront on the method’s intended use, validation expectations, and control strategy so that NGS adoption accelerates development and will discuss remaining challenges.
1100 – 1130
Systems That Deliver Reliably
Brian McCarthy, Spirax-Sarco Limited
Joanne Barrett, Spirax Sarco
Pharmaceutical manufacturing faces increasing pressure to simultaneously improve asset reliability, reduce operating costs, and deliver measurable progress toward net zero objectives—without compromising GMP compliance. This presentation explores a structured, maturity based approach to operational improvement that integrates asset health, energy intensity reduction, and data-driven decision making across regulated environments. Using real world industry examples, the session outlines how organizations can move from reactive, site specific optimisation toward a scalable operating model that continuously improves performance across utilities, clean steam, and process support systems. Particular focus is given to establishing baselines, identifying loss mechanisms, and embedding continuous improvement through cross functional collaboration and digital insight. The presentation also examines how staged decarbonization roadmaps can align technical interventions with corporate sustainability targets, regulatory expectations, and capital planning cycles. Attendees will gain practical insights into how structured operating frameworks can unlock faster payback, improved resilience, and a credible, auditable pathway to lower carbon pharmaceutical operations.
1100 – 1130
Governance - Risk - Readiness
Daniel Thorne Ringgaard, Kuatro Group
AI adoption in GMP is no longer a question of if but how. This session introduces a structured playbook inspired by operational readiness for making your quality management system AI-ready, covering both autonomous decision-making and human-in-the-loop decision support. We walk through the method end-to-end, covering policy and SOP updates, model specification templates, and risk assessments, then deep-dive into the AI validation SOP and model specification, showing their contents, structure, and how they were implemented at a pharmaceutical manufacturer. Attendees leave with a clear, replicable method for closing the gap between current QMS maturity and the governance structures needed for responsible AI deployment.
1100 – 1130
Digital - Data - Decision Integrity
Assuring the compliance of the validated state has been built on a lagging system of checks and balances that are defined in regulations and underpinned by ISPE GAMP 5 and C&Q Baseline Guide 5 guidance. With the advent of digital technologies, maturing Document management systems, and Quality Management Systems, this lagging system of periodic review is obsolete and not fit for purpose. The validated state should be managed in real time, with up-to-date monitoring and processes that ensure the validated state is maintained and any deviation from this state can be addressed in a timely manner. A validated digital dashboard of information should be available for each system(s) to demonstrate that the validated state is maintained.
1100 – 1130
From Breakthrough to Bedside
ATMPs are challenging traditional QA and RA models in ways many organizations were not built to support. Compared with conventional products, they involve greater manufacturing complexity, higher variability, and tighter timelines, making process inefficiencies more visible. This session will explore where bottlenecks typically arise, including QC turnaround, batch review, deviation handling, and governance. Drawing on practical examples and ATMP Forum perspectives, it will highlight ways to improve speed and decision-making through risk-based approaches, rapid testing strategies, electronic batch records, and review-by-exception. Attendees will leave with practical ideas for identifying friction points and supporting more effective operations across growing ATMP organizations.
1130 – 1200
Systems That Deliver Reliably
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 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. Recent case studies, presented by the contributing manufacturer companies themselves, 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.
1130 – 1200
Governance - Risk - Readiness
Ulrich Koellisch, PhD, GXP-CC GmbH
Pradeep Ravindra, Koerber Pharma Software, Inc.
Generative Artificial Intelligence (GenAI) offers significant efficiency gains in pharmaceutical quality systems, yet its use in GxP-environments raises critical challenges around data integrity, traceability, and regulatory compliance.
Current and evolving regulatory expectations, such as the FDA’s draft guidelines and EU GMP Annex 22 draft, set requirements for the trustworthy use of AI systems and have triggered broad industry discussion on how to implement probabilistic models, such as Large Language Models, in GxP applications. This underscores the need for clearly defined control mechanisms, explainability, and risk-based governance.
This presentation introduces a validation and data-governance framework tailored for the Retrieval-Augmented Generation (RAG) architecture operating in GxP-context. It combines GAMP® 5 Second Edition principles with structured controls for data, model, and infrastructure to ensure that AI-driven processes remain qualified, traceable, and secure.
Key compliance elements include:
- validation and change control for automated data flows
- versioned and approved model registries
- access controls within agentic architectures
- cybersecurity safeguards across connected components
1130 – 1200
From Breakthrough to Bedside
George Todorov, IPS - Integrated Project Services LLC
Nikeeta Surani, IPS - Integrated Project Services
With increasing demand to improve patient access to autologous cell therapies, facility design decisions are becoming a critical driver of both cost and speed to clinic. At the same time, evolving GMP expectations continue to add complexity to capital projects, creating a persistent challenge for drug developers and CDMOs. Organizations are often faced with deciding whether to retrofit existing spaces or design and build new facilities—frequently relying on multiple front-end design studies to evaluate options. Rather than embarking on this costly and iterative path, a structured facility design risk assessment can be used to narrow down design options ahead of embarking on conceptual and basic design. IPS implemented this approach to evaluate three HVAC and biosafety cabinet (BSC) configurations considered at a client facility:
- Single-pass air in suite with recirculating BSCs
- Recirculated suite air with ducted BSCs
- Recirculated suite air with recirculating BSCs
1130 – 1200
Digital - Data - Decision Integrity
Yiming Peng, Genentech Inc
Scaling AI/ML insights across complex global networks is challenging. This session presents a mature case study: an AI-enabled Product Health strategy transitioned to a customized digital platform. The innovation is a "Co-Pilot" model merging classic Statistical Process Control and cutting-edge AI/ML/GenAI with SME expertise. Moving beyond periodic reviews, the platform provides AI-enhanced monitoring and configurable alerts for process deviations. Critically, it enables data-driven process output optimization, shifting from descriptive monitoring to predictive control, currently deployed for key products. This framework aims to scale proactive risk management at the product and portfolio level. Complex issues trigger Data Science deep-dives. With the foundational platform live, we demonstrate a scalable framework for Decision Integrity. Attendees will learn to operationalize expert knowledge with AI/ML lifecycle controls, ensuring product quality and supply reliability in a Pharma 4.0 ecosystem.
1200 – 1330
1330 – 1400
Digital - Data - Decision Integrity
Naheed Sayeed, Apotex
Xiande Yang, PhD, Apotex Inc.
Cleaning Validation (CV) and Process Validation (PV) are regulatory requirements in pharmaceutical manufacturing and require extensive data analysis and report writing on a recurring basis. Traditionally, these activities demand significant manual effort each year. By designing robust statistical methodologies, this repeated work can be transformed into AI‑driven automation, reducing manual effort by up to 98%. We developed and validated CV statistical methodologies, published in AAPS PharmSciTech, and implemented an end‑to‑end AI automation system that generates analysis‑ready datasets and regulatory‑compliant reports. The system integrates and digests QMS and LIMS raw data using Python, SQL, and R, and is deployed in a Microsoft Azure Databricks environment to ensure scalability, security, and compliance. This approach enables rapid, consistent, and reproducible cleaning validation analytics and report generation. Process Validation (PV) can be realized using the same framework, extending the benefits of automation across validation lifecycle activities.
1330 – 1400
Governance - Risk - Readiness
Michael Grischeau, AbbVie Inc
FDA Speaker Invited
This ISPE Advancing Pharmaceutical Quality Program is intended to provide a practical framework that an organization can use to first assess the maturity and then advance the state of quality within its organization. It is a quality management maturity program that aims to identify good practices and good behaviors that support the continual improvement of quality management effectiveness within an organization. The APQ program is intended to be comprehensive, but it is not complex. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. The Advancing Pharmaceutical Quality (APQ) Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act & Advance Framework. This structured framework provides practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can first be evaluated and then improved upon. We will discuss the model, learnings from case studies, and application to the FDA QMM pilot. The FDA will discuss learning from its first two FDA QMM pilots.
This ISPE Advancing Pharmaceutical Quality Program is intended to provide a practical framework that an organization can use to first assess the maturity and then advance the state of quality within its organization. It is a quality management maturity program that aims to identify good practices and good behaviors that support the continual improvement of quality management effectiveness within an organization. The APQ program is intended to be comprehensive, but it is not complex. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. The Advancing Pharmaceutical Quality (APQ) Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act & Advance Framework. This structured framework provides practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can first be evaluated and then improved upon. We will discuss the model, learnings from case studies, and application to the FDA QMM pilot. The FDA will discuss learning from its first two FDA QMM pilots.
1330 – 1400
From Breakthrough to Bedside
Payton Fraley, Burns & McDonnell
Breakthrough biologic therapies only improve outcomes if they can be reliably manufactured and delivered to patients – even those with tails and four legs. This session examines how the first USDA-approved monoclonal antibody treatment for canine parvovirus scaled from development to commercial delivery, supporting veterinarians in saving puppies. The presentation explores a complex brownfield expansion executed within an operating commercial biologics facility to significantly increase upstream and downstream manufacturing capacity while preserving access to a novel veterinary biologic. Presented by the owner and engineering delivery team, it shows how early design decisions, phased construction, and risk-based planning minimized shutdown durations, protected product supply, and maintained inspection readiness across USDA and EU regulatory frameworks. Attendees will gain practical insights into translating scientific breakthroughs into manufacturable, scalable therapies, and how integrating engineering, quality, and manufacturing perspectives can accelerate patient access, even when capacity expansion must occur within narrow, carefully planned shutdown windows under tight operational and regulatory constraints.
1330 – 1500
People - Capability - Workforce of Delivery
1330 – 1400
In pursuit of sustainable pharmaceutical manufacturing, GSK has pursued a holistic, data and knowledge-driven framework to enable optimization against various environmental factors. This approach, referred to as EcoDesign, considers the entire product lifecycle, from design, through raw material inputs, manufacturing, and distribution, and ultimately to disposal. The end-to-end approach emphasizes the early incorporation of environmental considerations into processes, leading to a quantifiable reduction of environmental impacts while ensuring product quality. Use of the EcoDesign model enables identification of key interventions and prioritization for novel technology or process improvements. One key priority stemming from this effort is bioprocess intensification or the use of continuous bioprocessing. This presentation will provide background of the EcoDesign model and discuss the application of this model to several manufacturing processes, including bioprocess intensification and continuous bioprocessing. The intersection of this model-based approach and novel process technology and regulatory considerations will be highlighted, in addition to discussing future directions.
1400 – 1430
As pharmaceutical organizations navigate growing complexity, delivering reliably now requires more than optimizing individual functions—it demands integrated systems spanning facilities, manufacturing, quality, supply chain, and sustainability. This panel brings together industry leaders to share real‑world strategies for designing and operating connected, resilient systems that perform under pressure. Panelists will explore how Sustainability by Design principles, circular‑economy thinking, and ESG considerations are being embedded directly into operational and engineering decisions—not treated as downstream reporting activities. The discussion will also examine how AI and advanced analytics are influencing system predictability, risk anticipation, and decision‑making across global manufacturing and supply networks. Through practical examples and lessons learned, this session will move beyond theory to highlight what is working today, where challenges remain, and how organizations can evolve toward more reliable, sustainable, and adaptable operations.
1400 – 1430
Digital - Data - Decision Integrity
This presentation explores Merck's integration of Large Language Models (LLMs) into pharmaceutical manufacturing, leveraging Model Context Protocol (MCP) as a standardized API for deep system accessibility. This innovative approach is revolutionizing both engineering and operational workflows, demonstrating a significant leap towards Pharma 4.0. For AI for Engineering, the application of an LLM has enabled the faster creation of code and has significantly reduced configuration errors. In AI for Operations, the MCP-integrated LLM provides real-time, intelligent assistance to operators. For instance, in a bioreactor scenario, the LLM proactively reviews alarm events, analyzes critical process parameters against acceptable ranges, identifies anomalies (e.g., a low parameter value), and suggests corrective actions like increased set points. Furthermore, this system aids in showing deviations, analyzing trends, and generating comprehensive batch summary reports for critical units like lyophilizers, offering immediate benefits to both experienced and new personnel by enhancing decision-making and process understanding. A primary challenge involved integrating AI into the existing GxP landscape. This was overcome by developing a robust validation strategy and ensuring full auditability of the LLM's outputs and decisions, maintaining regulatory compliance and data integrity.
1400 – 1430
From Breakthrough to Bedside
Cole Brunson, Flad Architects
Eric Benkert, Promega Corporation
As life sciences manufacturing evolves at an accelerated pace, facilities must be designed to support current operations and anticipate future growth. Promega’s Chappelle Manufacturing Center (CMC) exemplifies how intentional pre-investment can enable long-term manufacturing expansion while minimizing disruption to ongoing operations. This session will explore how Promega, collaborating with Flad Architects and Affiliated Engineers, Inc. (AEI), embedded flexibility into the master planning, architectural design, infrastructure, and site development of the CMC. The presentation will detail how early identification of strategic growth assumptions across both manufacturing and support functions informed planning decisions and enabled flexibility over the life of the facility, including strategically located adjacencies and intentionally oversized spaces to accommodate future systems, equipment, and processes. We will also discuss site planning strategies that support future building additions for long-term operational value. Promega will share insights on how built-in flexibility enabled recent laboratory expansions, process improvements, and the addition of new GMP manufacturing capabilities. Additional discussion will highlight considerations unique to the CMC, including planning for future automation, safety, and code implications, and a strong commitment to human-centric design principles such as access to daylight, views, and well-being. Presenters will examine the cost-versus-benefit associated with flexibility.
1400 – 1430
This session introduces the Risk Management Maturity Model (RMMM), a practical framework developed to help organizations assess and strengthen how risk management supports safe, effective, and sustainable medical product development and lifecycle management. The model was created in response to a common industry problem: risk management is often performed as a fragmented or compliance-driven activity rather than as an integrated discipline that actively informs design, development, manufacturing, change management, and post-market decisions. Grounded in first principles of safety and effectiveness, the RMMM provides a structured way to evaluate how well risk management is embedded across functions, lifecycle stages, and decision processes. It is intended to help organizations move beyond checklist-based compliance and toward a more proactive, cross-functional, patient-focused, and decision-driving approach. The model addresses maturity across key dimensions such as leadership and culture, intended use and patient focus, lifecycle integration, traceability, cross-functional collaboration, fit-for-purpose processes and tools, regulatory alignment, transparency of decision logic, and organizational learning. The presentation will introduce the maturity levels of the RMMM and show how the model can be used to identify current-state gaps, guide improvement priorities, and strengthen confidence in both product and business decisions.
1430 – 1500
Systems That Deliver Reliably
Justin Wagner, Flad Architects
Jeff Steinhauer, Flad Architects
As Eli Lilly continues to expand its manufacturing footprint to meet growing patient demand, a reliable yet flexible quality control (QC) laboratory model is crucial. This presentation will cover many of the current trends and requirements driving planning and design of QC labs at large-scale pharma and biomanufacturing facilities today. Project leaders from Lilly and Flad Architects will discuss an effective QC lab model that Lilly has implemented across several sites. Topics will include effectively incorporating advanced technology such as automation, digitalization, and AI while planning for future growth and evolving space needs. As technology enables improved efficiency and regulatory compliance, the role of human oversight remains essential. The presentation will also detail the importance of designing facilities with a human-centric approach to support employee well-being. Additionally, the presenters will explore how to maintain a global connection with planning and delivery across sites with different requirements, as well as the advantages and challenges of parallel implementation versus a phased approach.
1430 – 1500
From Breakthrough to Bedside
Emnet Yitbarek, PhD, FDA/CBER
FDA Speaker Invited
This presentation explores Analytical Method Transfer (AMT) for biologics through a risk-based approach aligned with USP 1224> and cGMP requirements. Given the inherent complexity and variability of biological products, establishing a structured transfer strategy is essential to ensure analytical procedures perform consistently across global laboratory networks. Attendees will examine the scientific and regulatory frameworks of ICH guidelines and FDA expectations, learning how to translate these requirements into practical quality control operations. The session outlines a comprehensive workflow for AMT execution, including the strategic selection of transfer types—such as comparative testing, co-validation, revalidation, or waivers—and the development of statistically justified acceptance criteria. Through practical case studies featuring common physicochemical methods, the presentation highlights real-world challenges and best practices for mitigating equipment and reagent variability. Participants will gain actionable tools to design, execute, and document compliant transfers, bridging the gap between high-level regulatory theory and robust laboratory performance. By the end of the session, attendees will be equipped to maintain data integrity and product quality throughout the biologics lifecycle.
This presentation explores Analytical Method Transfer (AMT) for biologics through a risk-based approach aligned with USP 1224> and cGMP requirements. Given the inherent complexity and variability of biological products, establishing a structured transfer strategy is essential to ensure analytical procedures perform consistently across global laboratory networks. Attendees will examine the scientific and regulatory frameworks of ICH guidelines and FDA expectations, learning how to translate these requirements into practical quality control operations. The session outlines a comprehensive workflow for AMT execution, including the strategic selection of transfer types—such as comparative testing, co-validation, revalidation, or waivers—and the development of statistically justified acceptance criteria. Through practical case studies featuring common physicochemical methods, the presentation highlights real-world challenges and best practices for mitigating equipment and reagent variability. Participants will gain actionable tools to design, execute, and document compliant transfers, bridging the gap between high-level regulatory theory and robust laboratory performance. By the end of the session, attendees will be equipped to maintain data integrity and product quality throughout the biologics lifecycle.
1430 – 1500
Governance - Risk - Readiness
William Hauck, Shabas Solutions LLC
Sarah Akers, Shabas Solutions LLC
FDA’s Quality Management Maturity (QMM) Program represents a fundamental shift in how pharmaceutical operations are evaluated, from reactive compliance toward sustained excellence. Drawing on Shabas Solutions’ work with FDA CDER to design the initial QMM Assessment framework, this presentation shows how the QMM framework drives more comprehensive and proactive enterprise-wide transformation as compared to previous quality initiatives that have focused on traditional compliance. Attendees will gain an understanding of the five practice areas in FDA QMM (Advanced Pharmaceutical Quality System, Business Continuity, Management Commitment to Quality, Employee Engagement & Empowerment, and Technical Excellence), and receive practical strategies for integrating QMM principles into governance models (e.g., role of corporate HQ versus site level management, cross-functional responsibilities for quality) and risk management approaches to assure reliable market supply (e.g., front line ownership of quality, supply chain resilience, customer collaboration). Real world scenarios will illustrate how sites can embed resiliency, accountability, and proactive continuous improvement principles across operations. By framing QMM as both a regulatory and strategic marketing tool, the presentation demonstrates how companies can strengthen quality culture and resilience, reduce risk, and improve product reliability while preparing for an evolving regulatory landscape and increased customer expectations.
1430 – 1500
Digital - Data - Decision Integrity
Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes. Tools such as Artificial Intelligence (AI) might accelerate process development and allow better predictions of process trajectories. Even with the expanded use of process models, stakeholders report challenges with the development, implementation, verification/validation, registration, and lifecycle management of models. To address this heath authorities have proposed context dependent risk-based frameworks to establish the credibility of models used for pharmaceutical manufacturing: FDA Draft Guidance for Industry Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, and EMA’s Preliminary QIG Considerations regarding Pharmaceutical Process Models. Additional health authorities, such as PDMA, have also announced plans to propose guidelines for the development and validation of process models. The presentation will provide a case study sharing a practitioner’s perspective on implementing these frameworks and how they can be integrated with existing risk management practices such as ICH Q9. The presentation will discuss the benefits and challenges in operationalizing the proposed context-dependent risk based credibility frameworks and identify opportunities for further international harmonization.
1500 – 1600
1600 – 1730
People - Capability - Workforce of Delivery
1600 – 1630
Digital - Data - Decision Integrity
Stephanie White, Alliance BIO
Many life sciences organizations recognize the limitations of paper-based or disconnected validation processes, yet struggle to build a clear, credible case for investing in a digital validation platform. This presentation provides a practical, real-world strategy for developing that case in a regulated environment. Using a step-by-step “how-to” approach, attendees will learn how to identify current-state pain points, define business and compliance value drivers, engage key stakeholders, and translate digital validation capabilities into measurable outcomes. The session will focus on common decision criteria such as cycle-time reduction, improved traceability, stronger collaboration, better inspection readiness, and more consistent execution across commissioning, qualification, and validation activities. It will also address common barriers to approval, including cost concerns, change management challenges, and difficulty quantifying return on investment. Attendees will leave with a repeatable framework they can apply within their own organizations.
1600 – 1630
Systems That Deliver Reliably
Oscar Garcia, Fluor Enterprises
Katarzyna Grudnik, Fluor
Gregory Lepak, Fluor
Water is a vital yet often underestimated resource in biomanufacturing. Despite its essential role, its low cost frequently leads to underappreciation and missed opportunities for sustainable innovation. As sustainability becomes a core element of pharmaceutical production, the strategic management of high purity water used in cell culture, cleaning, and purification gains increasing importance. This presentation explores the challenges of implementing water sustainability in Biopharma facilities. It introduces the 3R strategy: Reduce, Reuse, Recycle, as a practical framework for minimizing water use without compromising product quality.
The presentation proposes actionable opportunities in mammalian cell culture and microbial fermentation to reduce net water consumption. It further includes water production systems and Cleaning In Place (CIP) operations, for sustainability action, which account for up to 40% of water usage in biopharma facilities. The insights presented are also relevant to other industries that rely on high-purity water and CIP. By showcasing real-world applications of the 3R approach, the presentation aims to inspire facilities to identify water-saving potential and implement tailored solutions. Sustainable water management supports environmental goals and enhances operational efficiency.
The presentation proposes actionable opportunities in mammalian cell culture and microbial fermentation to reduce net water consumption. It further includes water production systems and Cleaning In Place (CIP) operations, for sustainability action, which account for up to 40% of water usage in biopharma facilities. The insights presented are also relevant to other industries that rely on high-purity water and CIP. By showcasing real-world applications of the 3R approach, the presentation aims to inspire facilities to identify water-saving potential and implement tailored solutions. Sustainable water management supports environmental goals and enhances operational efficiency.
1600 – 1630
Governance - Risk - Readiness
1600 – 1630
From Breakthrough to Bedside
Srigana Padamati, Lonza
Daniel Swanson, IPS
Successful capital project execution in the biopharmaceutical industry requires rigorous upfront planning to control cost, schedule, and operational risk. Analytical laboratories, however, are frequently underrepresented in early project phases. When they are considered, Analytical laboratory sizing is often based on static spreadsheets and engineering judgment, increasing the likelihood of bottlenecks, underutilized assets, and late-stage design rework. This presentation introduces a process modeling–based framework that integrates dynamic simulation into capital project planning to support more defensible, data-driven laboratory design decisions. The approach links process sampling strategies with analytical laboratory capacity, enabling teams to identify testing constraints and scheduling conflicts before facility layouts are locked. Case study results demonstrate how this methodology can provide better visibility into equipment selection and improved staffing projections. The framework also enables evaluation of operational scenarios such as facility ramp-up, campaign sequencing, and changes in production strategy, providing greater flexibility and resilience in laboratory design. Attendees will gain practical insight into how process modeling tools can be embedded into stage-gate capital project workflows, bridging the gap between process development and facility design to accelerate project delivery and improve asset utilization from day one of operations.
1630 – 1700
Digital - Data - Decision Integrity
Martin Heitmann, MH Consulting & Advisory GmbH
AI is not simply introducing new tools – it changes how GxP computerized systems operate. Execution shifts toward supervision, and deterministic behavior changes towards probabilistic outcomes. This shift does not reduce the need for Quality Assurance – it elevates it. Quality no longer emerges just from validating isolated systems, but from the interaction of business processes, data, software, interfaces, and decision structures. QA evolves from a control function into an architect of processes to achieve controlled and reliable digital system landscapes. Responsible AI is not an add-on. It must be embedded into system architecture – including intended use, human oversight, and risk-based controls across the full lifecycle. AI operates on statistical inference, probability, and plausibility, not understanding. This creates a structural gap between plausible outputs and correct decisions. Closing this gap is a matter of system design. In this presentation, we will:
- explain how AI transforms computerized systems and validation approaches
- introduce Progressive QA as a response to increasing speed and complexity
- demonstrate how human oversight must be designed into system architecture
- show how insufficient oversight leads to inefficiency, risk, and loss of trust
- outline how modern QA shapes scalable, reliable, and compliant AI-enabled environments
1630 – 1700
Systems That Deliver Reliably
Jack Polce, Arcadis US, Inc.
Water plays a critical role at every stage of pharmaceutical manufacturing, yet its full value and total lifecycle costs are frequently underestimated within facility and manufacturing operating models. This presentation will go beyond conventional water reduction strategies by illustrating how a holistic, front-end engineering approach can yield substantial operational, environmental, financial, and compliance benefits. Through a detailed case study, we will demonstrate how rethinking water’s role and value within pharmaceutical operations can deliver measurable reductions, enhance resilience, and drive progress toward sustainability goals. By implementing a series of engineering-led water kaizens aligned with S/QbD (a continuous improvement strategy aimed at identifying significant water reduction), we achieved savings of 220 M litres, realised $4.0M in capital expenditure (capex) savings, and $1.9M in operational expenditure (OpEX) savings over 10 years. The optimised water management system was transitioned to the operational teams, who have since continued to identify and implement further efficiencies.
1630 – 1700
Governance - Risk - Readiness
The ISPE Pharma 4.0™ Operating Model identifies governance structures as a foundational prerequisite for any lasting digital transformation — yet when it comes to cloud-based collaboration between pharmaceutical companies and National Regulatory Agencies, governance remains the critical missing layer. Technology has outpaced the legal, institutional, and operational frameworks needed to make such collaboration inspectable, accountable, and scalable. This presentation reports on a live case study with a pharmaceutical company and a regulatory agency, using a cloud collaboration environment operated by a Trusted Multiparty Operator with a patented multilateral governance mechanism. The case study explores four governance pillars: (1) legal and legislative frameworks beyond contractual terms; (2) IP ownership, data sovereignty, and liability; (3) programmable, consensus-driven decision-making; and (4) auditable trust through cryptographic verification and on-demand compliance reporting. Aligned with this track's call for novel regulatory reliance models and collaborative pathways, the session concludes with a governance implementation roadmap, a blueprint that enables industry and agencies discussion to address the governance blind spot in regulatory cloud collaboration: how to move cloud regulatory collaboration from pilots to inspectable, accountable practice.
1630 – 1700
From Breakthrough to Bedside
Derek Schorzman, PhD, Liquidia Corporation
Particle replication in non-wetting templates (PRINT®) is a particle-engineering platform developed at Liquidia Technologies that harnesses the precision of lithographic manufacturing techniques from the semiconductor industry to produce pharmaceutical particles of tightly controlled size, shape, and composition at commercial scale. The resulting platform enables the production of custom engineered particles of pre-determined and consistent size and shape. The chemical composition, mechanical, and other properties can similarly be designed to enable a wide range of custom particle populations. Small molecules, proteins, monoclonal antibodies, nucleic acids, sugars, amino acids, lipids, biodegradable polymers, steroids, and many other cargoes have all been incorporated into PRINT particles in research and development projects. Liquidia has translated this new technology into a commercially viable production platform capable of manufacturing pharmaceutical products. In May 2025, the FDA approved YUTREPIA®, an inhaled dry powder formulation of treprostinil to treat PAH and PH-ILD, validating the platform as the first commercial product manufactured using PRINT technology. The INSPIRE and ASCENT multicenter open-label safety and tolerability trials have demonstrated that high doses of inhaled treprostinil can be delivered and maintained with a uniform particle population. This presentation will highlight Liquidia’s story from bench-top curiosity to drug product approval and commercialization.
1700 – 1730
From Breakthrough to Bedside
The updated ICH Q1 draft explicitly encourages scientifically justified, model‑informed strategies for shelf‑life estimation. Kinetic modelling aligns perfectly with this direction: it provides a rigorous, transparent framework for extrapolation, supports risk‑based decision‑making, and strengthens the overall stability argument for regulatory submissions. Rather than relying solely on time‑consuming real‑time studies, companies can integrate kinetic insights early, refine formulations faster, and reduce uncertainty in product performance. The benefits are enormous. Development timelines shrink. Stability failures are detected earlier. Resources shift from repetitive testing to strategic experimentation. And because kinetic models capture the true behaviour of a product under stress, they offer a level of predictive power that conventional approaches simply cannot match. This session will show how adopting advanced kinetic modelling not only aligns with regulatory expectations but also unlocks a smarter, more agile, and more scientifically robust path to pharmaceutical stability assessment.
1700 – 1730
Governance - Risk - Readiness
Most organizations with AI-enabled systems in GxP environments know they need inspection-ready documentation. Far fewer have a complete, coherent narrative that holds up when an inspector works through it chapter by chapter. This workshop closes that gap. Participants bring a real or hypothetical AI use case and work through a structured playbook framework in a facilitated, chapter-by-chapter format. Tables are assigned one chapter each: intended use, GxP and data classification, data flow, documentation structure, lifecycle and monitoring, release management, and access controls. Each group builds their chapter, then presents back to the room. The result is a composite, end-to-end picture of what a complete, inspection-ready AI narrative looks like across all seven dimensions. Owner company participants with live AI deployments are specifically encouraged to anchor their table's discussion in what they actually had prepared going into their last inspection or audit, and what they wish they had ready. That grounded perspective is what moves the room from framework to reality.
1700 – 1730
Digital - Data - Decision Integrity
Katie Duncan, PhD, Gsk
Step 1 of the ICHM4(Q) revision is a landmark event, and ICH is not looking to the implementation of this, and the development of the guidance and tools for structured product quality submissions (SPQS) submissions. Both ICH M4Q(R2) and ICHM16 can now be considered in light of the capability to automate the delivery using generative AI of CMC submissions and PQS documentation. This session would seek to bring these threads together to assess how the dossier of the future can be used to deliver innovative products and manufacturing processes. The session would include:
- The use of the ICHM4Q functionality to support new modalties and control strategies
- An industry vision for ICHSQPS and how this enable M4Q implementation
- How generative AI and data architecture will link to support the dossier of the future
- How this is linked to the design and implementation of new EU legislation in delivering lifecycle changes and enabling innovation.
1700 – 1730
Systems That Deliver Reliably
Jochen Schmidt-Nawrot, CRB Group GmbH
SCHOTT Pharma Schweiz AG partnered with CRB to redesign its Water for Injection (WFI) generation strategy, moving away from conventional multi-stage distillation toward a membrane-based solution tailored to real operational demands. A constant 24/7 requirement for hot WFI—primarily driven by washing processes—served as the foundation for the system design and technology selection. The project followed a phased implementation approach, allowing uninterrupted production while achieving full redundancy and compliance with current GMP expectations. Key elements of the concept include integrated thermal sanitization, optimized heat recovery, and a system architecture designed for long-term reliability and efficiency. Based on real operating data, the new WFI system demonstrates a substantial improvement in energy performance alongside a tangible reduction in carbon emissions. This case study illustrates how carefully aligned engineering decisions, combined with regulatory foresight and sustainability goals, can deliver both environmental and operational value in pharmaceutical utilities.
1930 – 2200
Women in Pharma® Monday Night Networking Event Women in Pharma’s signature Monday Night Networking Event returns in 2026, bringing together professionals from across the pharmaceutical industry for an evening of connection, conversation, and community. This special off-site networking experience is designed to create meaningful opportunities to build relationships, exchange ideas, and celebrate the impact of women and allies across the industry. Attendees will enjoy an engaging atmosphere with guided conversation, interactive networking, and moments that encourage deeper connection beyond the traditional reception format. Whether you are reconnecting with familiar colleagues or meeting new peers, this event offers a welcoming space to expand your network, share experiences, and be part of the continued growth and momentum of Women in Pharma. Separate fee and registration required. Limited Space
0700 – 1800
0700 – 0800
0815 – 0845
0845 – 0915
General Session
0930 – 1030
0930 – 1530
1030 – 1100
From Breakthrough to Bedside
Alice Melocchi, Multiply Labs Inc
Shanshan Liu, Fedegari
Automation is transforming ATMP manufacturing by reducing variability and enabling more repeatable and reproducible processes. As advanced therapies move toward broader clinical and commercial application, ensuring robust process control, product quality, and scalability becomes increasingly critical. This presentation explores how automated manufacturing platforms, including robotic technologies, can enhance consistency across critical unit operations, minimize operator-dependent variability, and strengthen overall process reliability. It will also explore how these concepts are translated into real-world solutions to address common regulatory observations. By integrating automation into ATMP workflows, organizations can move toward a more controlled, scalable, and inspection-ready manufacturing model —ultimately supporting the patient needs.
1030 – 1100
Digital - Data - Decision Integrity
Anant Agrawal, CIMCON Software Inc
GenAI adoption in regulated life sciences is accelerating, but one element consistently underestimated in practice is human-in-the-loop governance. Regulatory frameworks call it out explicitly, yet organizations routinely treat it as an afterthought, bolted on after deployment rather than designed in from the start. The result: accountability gaps, traceability failures, and oversight burdens that scale faster than the AI value they're meant to protect. Drawing on work with hundreds of pharma organizations, this session examines what effective human-AI collaboration actually looks like across real GenAI deployments. It covers how to structure points of human intervention when inputs include unstructured data, natural language prompts, and tacit process knowledge; how to enforce accountability as AI Agents take on autonomous actions within GxP workflows; and how organizations can provide meaningful oversight at scale without creating bottlenecks that neutralize the business case. Attendees will leave with a practical governance model grounded in real case studies, directly applicable to their own AI adoption programs.
1030 – 1100
Systems That Deliver Reliably
Gwendolyn Foster, Lonza
Across the pharmaceutical industry, standardization has become a central strategy for improving the speed, cost, and reliability of GMP facility delivery. Standard equipment selections, template URS, and predefined layouts are now widely used. Despite this, delivery outcomes often remain largely project-specific, with limited compounding benefit across successive builds. This highlights a gap between standardization and true platform-based delivery. In many organizations, standards are developed within individual domains but are not aligned across the full delivery stack, including process design, automation, data models, and qualification approaches. As a result, integration effort remains high, variability persists, and similar systems are repeatedly engineered and verified with limited reuse. Drawing on experience across multiple capital programs, this presentation introduces a practical framework for moving from component-level standardization to platform-based facility delivery. It focuses on enabling reuse through stable interfaces, modular process definitions, and aligned automation and data architectures, supported by a consistent, risk-based approach to qualification. The approach reframes initial implementations as platform-establishment efforts, enabling reduced rework, more efficient integration and commissioning, and improved schedule predictability across repeat facility builds.
1030 – 1200
People - Capability - Workforce of Delivery
1030 – 1100
Governance - Risk - Readiness
Jessica Hale, Merck & Co Inc
Supply resiliency and proactive drug shortage prevention measures are top of mind globally. This session will serve to introduce the ISPE Drug Shortages Initiative (DSI) and highlight its drug shortage prevention tools, such as the 2023 ISPE Drug Shortages Prevention Model (DSPM) and the development of a complementary, updated assessment and prevention tool which manufacturers can leverage to elevate their current approaches and practices for drug shortage prevention excellence, as part of continual improvement. The Drug Shortages Assessment and Prevention Tool provides the “how to”, whereas the 2023 ISPE Drug Shortages Prevention Model (DSPM) provides the “what and why” of drug shortage prevention.
1100 – 1130
Systems That Deliver Reliably
Pharmaceutical manufacturing environments depend on multiple functions working together seamlessly, from maintenance, to quality, to supply chain and production. Yet in many organizations, core operational platforms such as Enterprise Asset Management (EAM), Quality Management Systems (QMS), and Enterprise Resource Planning (ERP) systems remain isolated, limiting visibility and slowing decision-making. This session explores how sharing operational and quality data across these systems creates a resilient, insight-driven manufacturing ecosystem. Using a real-world case study from a GMP-regulated manufacturer, we will demonstrate how harmonized asset, maintenance, deviation, and supply chain data improves reliability, strengthens compliance, reduces unplanned downtime, and enables measurable sustainability outcomes. Attendees will gain practical guidance on building a cross-system integration strategy aligned with ISPE’s Pharma 4.0 principles, Sustainability/Quality by Design (S/QbD), and risk-based lifecycle approaches. The session will focus on operational impact, governance considerations, measurable results, and lessons learned to provide a framework that can be applied across manufacturing networks of all sizes.
1100 – 1130
From Breakthrough to Bedside
Jason Warfel, PhD, Bristol Myers Squibb
Analytical control strategies have historically relied on process capability and batch history, resulting in conservative, inflexible specifications that are not directly linked to patient impact. This limits the ability to leverage scientific understanding to support lifecycle agility and increases the risk of unnecessary rejection of safe and effective batches. We present a practical, risk-based framework for developing patient-centric analytical control strategies and specification approaches grounded in scientific and clinical understanding. Aligned with key concepts from the ICH Q6 revision, the framework integrates holistic control strategy design, structured CQA assessment, and a knowledge-based approach that draws on product and process development, non-clinical and clinical data, prior knowledge, and targeted structure-function characterization studies to define clinically relevant attribute boundaries. We address a key regulatory challenge—the expectation that tight specifications are required to ensure process consistency—by demonstrating how process consistency can instead be assured through complementary control strategy elements, including parametric process controls and continuous process verification within the pharmaceutical quality system. Case studies demonstrate the successful application of this framework across multiple commercial biologics, demonstrating its ability to justify clinically relevant acceptance criteria, reduce redundant testing, and enable more efficient post-approval change implementation while maintaining a high level of product quality assurance.
1100 – 1130
Digital - Data - Decision Integrity
The pharmaceutical industry currently faces a "data tax" on innovation, where critical information remains fragmented in functional silos and trapped in proprietary systems. To overcome this, the ISPE Pharma Open Data Space (PODS) initiative introduces a federated ecosystem designed for trusted collaboration and universal interoperability. This presentation explores the technical and scientific shift from localized digital pilots to Business Excellence at scale. Attendees will learn how PODS leverages open-source standards - such as the Asset Administration Shell (AAS), OPC UA, and MTP for digital modeling and automation - to enable secure data sharing without compromising intellectual property. We will detail the roadmap for "Plug & Produce" architectures that transform physical equipment into standardized digital assets, reducing bespoke integration costs and accelerating time-to-market. By aligning with the Pharma 4.0™ Operating Model, PODS moves the industry toward a "Golden Thread" of data integrity by design. Participants will gain insights into real-world use cases, from automated calibration to cross-sector clinical research, providing a pragmatic pathway to a machine-readable, future-proof pharmaceutical value chain.
1100 – 1130
Governance - Risk - Readiness
Maria Amaya, PhD, Genentech, A Member of the Roche Group
Supply resiliency and proactive drug shortage prevention measures are top of mind globally. This session will serve to introduce the ISPE Drug Shortages Initiative (DSI) and highlight its drug shortage prevention tools, such as the 2023 ISPE Drug Shortages Prevention Model (DSPM) and the development of a complementary, updated assessment and prevention tool that manufacturers can leverage to elevate their current approaches and practices for drug shortage prevention excellence, as part of continual improvement. Supply resiliency requires a quality-first mindset, and performance in cultural excellence is a continual improvement process. With engagement from industry and regulators, a Cultural Excellence blog is being developed summarizing the outcome of this discussion. This session will highlight industry and regulator thoughts, experience, and expectations for companies to elevate their current practices in cultural excellence.
1130 – 1200
Systems That Deliver Reliably
Tim Lash, PM Group
Swathi Karthik, Takeda
Voke Dortie
Multi‑product biologics facilities increasingly rely on single‑use systems to enable flexibility, rapid changeover, and scale. However, manual interventions and a lack of single-use standardization can introduce variability, elevate contamination risk, and compromise supply reliability. This case study shares a practical, risk-based approach deployed in a live commercial facility to strengthen sterility assurance and system reliability. A quasi‑quantitative risk‑scoring framework was developed to assess sterile boundary risks, enabling objective comparison between existing configurations and a standardized, modular design. The proposed modular design strategy reduces complexity, minimizes interventions, and improves consistency across processes. Application of this approach resulted in an estimated 69% reduction in risk of contamination on the sterile boundary. Once defined, the design could be scaled across multiple products and implemented in phases with minimal disruption to ongoing operations. This work demonstrates how standardization and risk-based design can create more resilient, sustainable, and operationally efficient manufacturing systems that reliably deliver therapies to patients.
1130 – 1200
Digital - Data - Decision Integrity
Khaled Moussally, Compliance Group Inc
Louie Rayal, GSK UK
FDA Speaker Invited
Validation timelines are under pressure. Regulatory expectations are not easing, yet organizations are expected to move faster with leaner teams. AI is emerging as a credible, compliant solution, and early adopters are demonstrating that speed and rigor are not mutually exclusive. This presentation examines how AI is being applied across the validation lifecycle within a Computer Software Assurance (CSA) framework, from risk assessment and FMEA development to test script generation, execution traceability, and summary report authoring, aligned with the FDA's CSA guidance, ICH Q9(R1), and GAMP 5 Second Edition. CSA's critical thinking and risk-based approach creates a natural home for AI-assisted validation: less documentation for documentation's sake, more evidence where it matters. Attendees will see how AI accelerates the "thinking work" of assurance, identifying critical functionality, scoping testing intelligently, and generating audit-ready rationale, while keeping human judgment firmly in control of decisions that affect patient safety. The session addresses common regulatory concerns directly: data integrity, human oversight, and auditability of AI-assisted decisions.
Validation timelines are under pressure. Regulatory expectations are not easing, yet organizations are expected to move faster with leaner teams. AI is emerging as a credible, compliant solution, and early adopters are demonstrating that speed and rigor are not mutually exclusive. This presentation examines how AI is being applied across the validation lifecycle within a Computer Software Assurance (CSA) framework, from risk assessment and FMEA development to test script generation, execution traceability, and summary report authoring, aligned with the FDA's CSA guidance, ICH Q9(R1), and GAMP 5 Second Edition. CSA's critical thinking and risk-based approach creates a natural home for AI-assisted validation: less documentation for documentation's sake, more evidence where it matters. Attendees will see how AI accelerates the "thinking work" of assurance, identifying critical functionality, scoping testing intelligently, and generating audit-ready rationale, while keeping human judgment firmly in control of decisions that affect patient safety. The session addresses common regulatory concerns directly: data integrity, human oversight, and auditability of AI-assisted decisions.
1130 – 1200
Governance - Risk - Readiness
FDA Speakers Invited
With the global influences driving changes to supply chains, the audience will hear from FDA regulators on how ensuring a quality culture is imperative to preventing shortages and ensuring supply continuity for patients. Supply resiliency and proactive drug shortage prevention measures are top of mind globally. This session will serve to introduce the ISPE Drug Shortages Initiative (DSI) and highlight its drug shortage prevention tools, such as the 2023 ISPE Drug Shortages Prevention Model (DSPM) and the development of a complementary, updated assessment and prevention tool that manufacturers can leverage to elevate their current approaches and practices for drug shortage prevention excellence, as part of continual improvement.
With the global influences driving changes to supply chains, the audience will hear from FDA regulators on how ensuring a quality culture is imperative to preventing shortages and ensuring supply continuity for patients. Supply resiliency and proactive drug shortage prevention measures are top of mind globally. This session will serve to introduce the ISPE Drug Shortages Initiative (DSI) and highlight its drug shortage prevention tools, such as the 2023 ISPE Drug Shortages Prevention Model (DSPM) and the development of a complementary, updated assessment and prevention tool that manufacturers can leverage to elevate their current approaches and practices for drug shortage prevention excellence, as part of continual improvement.
1200 – 1415
1415 – 1545
1545 – 1715
People - Capability - Workforce of Delivery
1545 – 1715
Systems That Deliver Reliably
1545 – 1715
Digital - Data - Decision Integrity
1545 – 1715
Governance - Risk - Readiness
1545 – 1715
From Breakthrough to Bedside
1900 – 2300
Get ready for an unforgettable night at Topgolf National Harbor on Tuesday, 20 October from 1900–2300! Immerse yourself in an evening of unparalleled networking, indulge in great food and drinks, take your best shot in the bays, hit the dance floor, and soak in the energy of a night designed for both fun and connection. Whether you're reconnecting with old friends or forging new professional relationships, this celebration is the perfect opportunity to mingle with industry leaders and colleagues. We’re turning up the volume with live music from Right Turn at 40, featuring ISPE’s own Dave DiProspero—bringing the perfect soundtrack to keep the party going all night long. No need to be a golfing pro, prepare to experience the best of what the pharmaceutical industry has to offer—this is an evening you won't want to miss!
Included with In-Person All-Access Pass, $225 For all other registration passes
Included with In-Person All-Access Pass, $225 For all other registration passes
0800 – 1300
0800 – 0900
0910 – 0940
General Session
0940 – 1000
1000 – 1130
General Session
1130 – 1200
General Session
1200 – 1215
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.