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
Thu, 22 Oct
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
Janie Miller, JahvanMed Advisors
Edoardo Tavazza, PQE Group
Karin Ann Payne, Johnson & Johnson
Maya Davis, PhD, ELIQUENT Life Sciences
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.
Janie Miller
CEO & Founder
JahvanMed Advisors
JahvanMed Advisors
Edoardo Tavazza
Strategic Business Development Director
PQE Group
PQE Group
Karin Ann Payne
Head of Regulatory Compliance
Johnson & Johnson
Johnson & Johnson
Maya Davis, PhD
Senior Vice President, Quality and Compliance Practice
ELIQUENT Life Sciences
ELIQUENT Life Sciences
Dori Gonzalez-Acevedo
Founder and CEO
ProcellaRX
ProcellaRX
Marla Phillips
CEO and President
Pathway for Patient Health LLC
Pathway for Patient Health LLC
1300 – 1600
Interactive Workshops
Stephanie White, DayOne Pharma Consulting
Amy Kuntzman, CAI
Phil Jarvis, No Deviation
Amy Wilhite, Kneat
Victor Bechmann, Danish Medicines Agency (DKMA)
Don Jackson, Perforce
Stephen Ferrell, Valkit.Ai
Matthew McMenamin, The Sentinel Consulting Group LLC
Mark Drinan, Takeda
Validation 4.0 is not a future state. It is a present capability — and this workshop demonstrates it end to end, across multiple platforms, through two deliberately contrasting real-world use cases. Discussions of AI in validation focus narrowly on test case generation. This workshop takes a fundamentally different view: it follows validation scenarios across the entire software lifecycle, from the moment a requirement is authored through to defect resolution and quality insight. Two use cases anchor the session — the validation testing of a Software as a Medical Device (SaMD) application, and the calibration of a thermocouple — chosen because together they span the full spectrum of what regulated organizations validate, from complex adaptive software to foundational GxP instrumentation. This session will use a mixture of common AI tools and DVT platforms to show how emerging technologies such as AI/RAG/MML can enable validation 4.0. The session opens with requirements authoring and moves through risk assessment, test case design, automated test execution, AI-assisted deviation detection, defect management, and quality insight generation. In the hands-on segment, participants choose their use case and run a simplified version of the lifecycle themselves. The session finishes with a structured governance and compliance discussion of regulatory expectations.
Stephanie White
Founder and Owner
DayOne Pharma Consulting
DayOne Pharma Consulting
Amy Kuntzman
Global Director, Quality
CAI
CAI
Phil Jarvis
Manager CQV and Digital Validation EU
No Deviation
No Deviation
Amy Wilhite
Senior Solution Validation Engineer
Kneat
Kneat
Victor Bechmann
Medicines Inspector
Danish Medicines Agency (DKMA)
Danish Medicines Agency (DKMA)
Don Jackson
Technical Evangelist
Perforce
Perforce
Stephen Ferrell
Chief Product Officer
Valkit.Ai
Valkit.Ai
Matthew McMenamin
Principal
The Sentinel Consulting Group LLC
The Sentinel Consulting Group LLC
Mark Drinan
Operational Technology (OT) Compliance Lead
Takeda
Takeda
1300 – 1600
Interactive Workshops
Eric Dong, FDA - CDER/OPQ/Office of Regulatory Practice for Pharmaceutical Quality (ORPPQ)
Maria Amaya, PhD, Genentech, A Member of the Roche Group
Celeste Frankenfeld Lamm, PhD, Merck & Co Inc
Adam Fisher, PhD, CDER/OPQ/OQA/PMS - FDA
Stephen Lichtenwalner, FUJIFILM Biotechnologies
Mary Manibusan, OQS, CDER, FDA
Line Lundsberg-Nielsen, Novo Nordisk
Toby Groathouse, 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.
Eric Dong
Policy Lead
FDA - CDER/OPQ/Office of Regulatory Practice for Pharmaceutical Quality (ORPPQ)
FDA - CDER/OPQ/Office of Regulatory Practice for Pharmaceutical Quality (ORPPQ)
Maria Amaya, PhD
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Genentech, A Member of the Roche Group
Celeste Frankenfeld Lamm, PhD
Senior Director, CMC and Quality Policy
Merck & Co Inc
Merck & Co Inc
Adam Fisher, PhD
Chair, CDER Emerging Technology Program
CDER/OPQ/OQA/PMS - FDA
CDER/OPQ/OQA/PMS - FDA
Stephen Lichtenwalner
Senior Project Manager
FUJIFILM Biotechnologies
FUJIFILM Biotechnologies
Mary Manibusan
Supervisory Research Analyst
OQS, CDER, FDA
OQS, CDER, FDA
Line Lundsberg-Nielsen
Senior Consultant
Novo Nordisk
Novo Nordisk
Toby Groathouse
Scientific Director, Regulatory Affairs
Novo Nordisk
Novo Nordisk
1300 – 1600
Interactive Workshops
Mark Muench, AbbVie, Inc.
Keith Beattie, Energy Efficiency Consultancy Ltd.
Norman Goldschmidt, Genesis AEC
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
Networking
Included with the All-Access Pass, check-in, un-wind and enjoy yourself at the ISPE Sunday Social! Conveniently located near registration in the Potomac Ballroom Foyer, overlooking the beautiful river, come join us for beverages and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2026 ISPE Annual Meeting & Expo off right!
1900 – 2230
Networking
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. The virtual live stream will begin at 1945 ET and will be available to access on the virtual conference platform.
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 to the ISPE Foundation 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. T-shirts are for registered participants and are available on a first-come, first-served basis. The 5K will be held in the National Harbor, along the Potomac River. The start/finish line will be located outside the Gaylord National property (toward the Gaylord Pier) at the bottom of the grassy knoll, along the water.
- 0545 - 0600: Participant check-in and onsite registrations.
- 0600 - 0615: Warm up and welcome remarks.
- 0615: Call the participants to the starting line and official start!
- 0700: Winner announcements for 1st, 2nd and 3rd place medals for men and women.
0700 – 1800
0700 – 0800
0800 – 0815
0815 – 0825
0825 – 0855
General Session
Wolfgang Wienand, PhD, Lonza
Dr. Wolfgang Wienand will discuss how Lonza, the world's leading contract development and manufacturing organization, helps transform breakthrough science into medicines that reach patients around the globe. Drawing on Lonza's role in supporting the launch and commercialization of more than 100 drugs since 2020, he will explore how the pharmaceutical industry is responding to growing demand for advanced therapies, expanding manufacturing capacity, and strengthening supply chain resilience. The keynote will also highlight the critical role of CDMOs in enabling innovation, particularly for emerging biotech companies, while managing the increasing complexity of novel modalities, global manufacturing networks, and evolving patient needs. Dr. Wienand will share perspectives on how manufacturers can maintain the highest standards of quality, reliability, and supply continuity while producing an increasingly diverse portfolio of products, technologies, and modalities across global manufacturing networks at scale.
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
0930 – 1030
Networking
Refreshments offered, including non-alcoholic beverages and light snacks.
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
0930 – 1900
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
0930 – 1900
Take a break and enjoy a friendly game of pickleball in the Expo Hall! The two courts are open Monday, 0930–1900, and Tuesday, 0930–1530. Participation is free, and attendees can sign up in person at the pickleball courts by completing the waiver. If you plan to play, you may wish to bring a change of clothes and/or athletic shoes for added comfort.
1030 – 1100
People - Capability - Workforce of Delivery
Kendrick Cox, Arcadis
Global workforce trends are evolving rapidly. Industries are being disrupted by technology and innovation, and there's a growing demand for new skills, so skill gaps are becoming more pronounced. By creating a skills-focused environment at Arcadis, we are addressing our skill gaps and improving our ability to meet client and market demands. This transformation allows us to remain competitive in the market, while attracting, retaining, and empowering our people to advance their careers within Arcadis, positioning us for strong collective growth. Adopting a skills-focused approach enables us to leverage our talented workforce from anywhere in the world to meet our client’s needs. We are becoming dynamic in matching people to opportunities, maximizing our productivity, and growing efficiently with our clients and in the markets where we have the right to win. Ultimately, this transformation positions Arcadis as an industry leader, poised to navigate evolving client demands and fuel meaningful growth.
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.
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
Hugh Devine, Valkit.Ai
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 – 1200
Parag Sane, Amgen Inc.
Scott Birth, AstraZeneca
Carmel Keane, Pfizer
Christopher Grail, Bayer AG
Rosa Manso, Eli Lilly And Company
Thomas Kelz, Takeda Manufacturing Austria AG
Giorgio Salciarini, BSP Pharmaceuticals
Jerome Daguenet, Sanofi
Gunter Baumgartner, Takeda
Dave DiProspero, CRB
This engaging panel discussion will bring together representatives from the 2026 FOYA Category Winning projects alongside a panel of seasoned FOYA judges.
Featuring insights from this year’s winning organizations, including Sanofi S.A., Takeda, Bayer AG, Hepalink Parmaceutical Group Co., Ltd., Eli Lilly & Company, AstraZeneca, BSP Pharmaceuticals SpA, Chugai Pharma Manufacturing Co., and FUJIFILM Biotechnologies, this session will provide an inside look at the real-world decisions, partnerships, and innovations behind some of the industry’s most exemplary facilities and projects.
- Explore the ideas, strategies, and innovations behind this year’s award-winning projects, highlighting how leading organizations are responding to evolving demands across facility design, construction, operations, sustainability, digital transformation, and patient impact.
- Hear from winning teams share the vision behind their projects, key challenges encountered, lessons learned, and the solutions that ultimately distinguished their submissions.
- Look across the 2026 winning projects for broader industry trends, examining how collaboration, technology, operational excellence, sustainability, and forward-thinking facility strategies are shaping the next generation of pharmaceutical manufacturing.
Attendees will leave with practical insights and fresh perspectives they can apply within their own organizations as the life sciences industry continues to raise the bar for facility excellence.
Parag Sane
AVP, Global Capital Projects
Amgen Inc.
Amgen Inc.
Scott Birth
Project Director
AstraZeneca
AstraZeneca
Carmel Keane
Vice President Global Engineering
Pfizer
Pfizer
Christopher Grail
SVP Global Pharma Engineering & Maintenance Excellence Lead
Bayer AG
Bayer AG
Rosa Manso
Vice President - Site Head
Eli Lilly And Company
Eli Lilly And Company
Thomas Kelz
Sustainability Manager
Takeda Manufacturing Austria AG
Takeda Manufacturing Austria AG
Giorgio Salciarini
Head of Sales - Technical Business Development
BSP Pharmaceuticals
BSP Pharmaceuticals
Jerome Daguenet
Head of Engineering for Modulus Program | Head of Project Delivery Asia
Sanofi
Sanofi
Gunter Baumgartner
SVP Head of Global Engineering
Takeda
Takeda
Dave DiProspero
Senior Fellow, Pharmaceutical Process| Sr. Associate
CRB
CRB
1030 – 1100
Systems That Deliver Reliably
Hamid Teimourian, AstraZeneca
Allyssa Wilcox, AstraZeneca
Alex Mason, AstraZeneca
This presentation reviews the implementation of AstraZeneca’s sustainability strategy at its largest global biologics manufacturing site in Frederick, Maryland, and shares the site’s 2015-2025 journey across energy, GHG, water, and waste. Since 2015, the site has undergone significant growth, with production increasing by more than 600%, while reducing its Scope 1 and 2 emissions by 98% from the 2015 baseline. We will discuss our corporate strategy and how it was executed through a decade-long program at the site level. We will also review how we are working toward the next major milestones in reducing Scope 3 emissions by engaging suppliers, optimizing material choices, and improving logistics, while protecting product quality and supply reliability.
1100 – 1130
People - Capability - Workforce of Delivery
Harry Benson, CAI
Desmond Wise, United Therapeutics
As the pharmaceutical and biotechnology industries face increasing workforce mobility, retirement of experienced professionals, and growing operational complexity, organizations risk losing critical knowledge faster than they can replace it. While many companies invest heavily in recruiting talent, few have established formal pathways to recognize, reward, and retain technical expertise. In this presentation, attendees will gain practical methods for preserving organizational knowledge, strengthening succession planning, and developing a culture where expertise is recognized as a strategic asset. We will explore how organizations can identify current and emerging subject matter experts (SMEs), establish clear qualification criteria for System Owners and Process Owners, and create a technical career path that provides recognition, advancement, and incentives comparable to traditional management roles. The discussion will include actionable steps to launch or enhance an SME recognition and qualification program that improves retention, engagement, and organizational resilience.
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 optimization toward a scalable operating model that continuously improves performance across utilities, pure 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.
Using real world industry examples, the session outlines how organizations can move from reactive, site specific optimization toward a scalable operating model that continuously improves performance across utilities, pure 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
Digital - Data - Decision Integrity
Stephen Ferrell, Valkit.Ai
Mark Drinan, Takeda
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
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: the policy and SOP updates required, the new artefacts that need to exist (model specifications, AI validation approaches, risk assessments), and the cross-functional governance that holds it all together. The session is anchored in examples from a pharmaceutical manufacturer, illustrating what an AI-ready QMS looks like when it meets real use cases.
Attendees leave with a clear, replicable method for closing the gap between current QMS maturity and the governance structures needed for responsible AI deployment.
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
From Breakthrough to Bedside
Prathyusha Guttikonda, Lonza
ATMPs are challenging traditional quality assurance and regulatory affairs 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 Quality Control 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
People - Capability - Workforce of Delivery
Barry Shortt, PhD, National Institute for Bioprocessing Research and Training (NIBRT)
National Institute for Bioprocessing Research and Training (NIBRT) Global Qualifications: Future-Ready Workforce
The global expansion of biopharmaceutical manufacturing is creating unprecedented pressure on organizations to develop a skilled, mobile, and future-ready workforce. To address this challenge, NIBRT has created the NIBRT Global Qualifications (NGQs) — a standardized, industry-aligned certification framework designed to harmonize bioprocessing training across international markets. This presentation will demonstrate how NGQs provide a consistent, competency-based approach to developing talent in core biologics manufacturing skills. It will examine the growing need for global training standards and show how NGQs are helping reduce variability in workforce capability, streamline onboarding, and enhance operational readiness for both new and expanding facilities.
Attendees will learn how NGQs are being implemented in collaboration with academic institutions, training organizations, and leading biopharma companies worldwide. The session will outline the qualification structure, delivery and assessment model, and mechanisms that ensure alignment with real-world GMP operations and emerging technologies. Participants will gain practical insights into how standardized qualifications can strengthen workforce pipelines, support organizational growth, and enable talent mobility in a rapidly evolving biopharma landscape. This session is ideal for HR leaders, workforce planners, training managers, and industry partners seeking scalable approaches to global talent development.
The global expansion of biopharmaceutical manufacturing is creating unprecedented pressure on organizations to develop a skilled, mobile, and future-ready workforce. To address this challenge, NIBRT has created the NIBRT Global Qualifications (NGQs) — a standardized, industry-aligned certification framework designed to harmonize bioprocessing training across international markets. This presentation will demonstrate how NGQs provide a consistent, competency-based approach to developing talent in core biologics manufacturing skills. It will examine the growing need for global training standards and show how NGQs are helping reduce variability in workforce capability, streamline onboarding, and enhance operational readiness for both new and expanding facilities.
Attendees will learn how NGQs are being implemented in collaboration with academic institutions, training organizations, and leading biopharma companies worldwide. The session will outline the qualification structure, delivery and assessment model, and mechanisms that ensure alignment with real-world GMP operations and emerging technologies. Participants will gain practical insights into how standardized qualifications can strengthen workforce pipelines, support organizational growth, and enable talent mobility in a rapidly evolving biopharma landscape. This session is ideal for HR leaders, workforce planners, training managers, and industry partners seeking scalable approaches to global talent development.
1130 – 1200
Systems That Deliver Reliably
Christian Lavarreda, Syntegon
Eilis Kelly, Johnson & Johnson
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, Umk Consulting GmbH
Pradeep Ravindra, Cellpath AI
Generative AI (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 A practical use case illustrates how a GenAI-enabled “Information-as-a-Service” supports MES users while maintaining audit readiness and adherence to ALCOA+(+) principles. The talk concludes by mapping the control requirements of current regulations to validation and governance activities that uphold patient-safety-relevant data integrity.
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.
1130 – 1200
From Breakthrough to Bedside
Andrew Huth, Sanofi
Pending revisions of the ICH Q1 guideline have created opportunities for the application of enhanced stability modeling approaches and the utilization of extrapolation methodologies in the development of biological products. In this presentation, a comprehensive introduction to Predictive Stability Modeling will be discussed, examining key frameworks of kinetic modelling. Perspectives on the challenges, achievements, and future expectations associated with these innovative analytical tools, informed by both industry and regulatory experience will be presented. An overview of the impact changes to ICH Q1 guidelines will be discussed; acknowledging for the first-time predictive stability modeling being shown as a complementary approach when limited real-time stability data is unavailable. Through illustrative case studies, a demonstration of how stability modelling can support shelf-life, facilitate the assessment of post-approval changes, contribute to the reduction of time to submission, and reduce development timelines will be discussed. A particular emphasis will be placed on the integration of predictive modeling into risk-based strategies, particularly in accelerated development contexts where expedited, evidence-based decision-making is critical to advancing therapeutic solutions to patients.
1200 – 1330
Networking
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
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.
1330 – 1400
People - Capability - Workforce of Delivery
Dwayne Ariola, Burkert Fluid Control Systems
Harold Woods, Daichi Mechanical
Life science manufacturing continues to advance through automation, AI, and new manufacturing technologies, but successful delivery still depends on capable people. Drawing on strong backgrounds in team building and operational performance, the presenters will explore practical approaches to developing talent from within rather than continually hiring to fill gaps as needs arise. The session will focus on building capability, transferring critical knowledge, identifying future leaders, and creating meaningful technical career paths while using technology to strengthen the experiences that build judgment, problem solving, and long-term performance. When you see your path, you can build your own road to success.
1330 – 1400
Sponsored Session
Jon Parfrey, Lowenco A/S
Ryan Pridgen, LOWENCO A/S
The cold storage transition in practice
Our client, a pharmaceutical manufacturer, will take the discussion from principles to practice and share a rare look into the considerations behind moving away from a familiar cold storage approach, and what happened when that decision met operational reality.
Our client, a pharmaceutical manufacturer, will take the discussion from principles to practice and share a rare look into the considerations behind moving away from a familiar cold storage approach, and what happened when that decision met operational reality.
Lifecycle perspective:
But operational performance is only one part of the equation. We will then widen the perspective to examine the lifecycle economics of different cold storage approaches, connecting engineering decisions with their long-term CAPEX and OPEX implications. If you are planning your next cold storage expansion, evaluating future capacity or defining the infrastructure strategy for a new facility, this session will leave you with a new perspective on whether the infrastructure you are planning today is ready for the demands of tomorrow.
1330 – 1400
From Breakthrough to Bedside
Payton Fraley, Burns & McDonnell
Jay Peterson, Elanco Animal Health
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 – 1400
Governance - Risk - Readiness
Jennifer Maguire, OPQ/CDER/FDA
Michael Grischeau, AbbVie Inc
Tami Frederick, PAI Pharma
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
Digital - Data - Decision Integrity
Naheed Sayeed, Apotex
Xiande Yang, PhD, Apotex Inc.
Cleaning validation and process validation are critical regulatory requirements in pharmaceutical manufacturing, requiring recurring, data-intensive analysis and comprehensive report generation. Traditionally, these activities rely heavily on manual data aggregation, statistical analysis, and documentation, resulting in significant resource burden, variability, and extended cycle times. This work presents a digitally enabled framework that transforms validation analytics through the application of robust, inspection-ready statistical methodologies and end-to-end automation. Apotex developed and validated novel statistical approaches for cleaning validation—published in AAPS PharmSciTech—and operationalized them through a citizen-developed AI automation solution. The platform integrates raw data from QMS and LIMS systems, and processes it using Python, SQL, and R within a secure Microsoft Azure Databricks environment.
The solution automates the generation of analysis-ready datasets and regulatory-compliant reports, reducing manual effort by up to 98% while improving consistency, traceability, and reproducibility. It ensures scalability and alignment with data integrity and compliance expectations in regulated environments. Importantly, the framework is extensible to process validation, enabling a unified, lifecycle-based approach to validation analytics. This innovation demonstrates how digital transformation, combined with sound statistical design and governance, can significantly enhance efficiency, compliance, and decision-making in pharmaceutical validation programs.
The solution automates the generation of analysis-ready datasets and regulatory-compliant reports, reducing manual effort by up to 98% while improving consistency, traceability, and reproducibility. It ensures scalability and alignment with data integrity and compliance expectations in regulated environments. Importantly, the framework is extensible to process validation, enabling a unified, lifecycle-based approach to validation analytics. This innovation demonstrates how digital transformation, combined with sound statistical design and governance, can significantly enhance efficiency, compliance, and decision-making in pharmaceutical validation programs.
1400 – 1430
Systems That Deliver Reliably
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
People - Capability - Workforce of Delivery
Magdalena Zalecka-Myszkiewicz, FLUOR
This presentation introduces a next‑generation modular biomanufacturing training facility built around single‑use, water-based bioprocessing concepts. The facility offers a safe, fully simulated manufacturing environment that mirrors real‑world layouts. Training is delivered through a blended “learn by teaching, showing, and engaging” framework, incorporating presentation spaces, VR-based experiential modules, and hands‑on work with process equipment. The modular construction strategy enables rapid deployment, scalability, and reconfiguration to support new modalities or shifts toward pilot-scale production or technology transfer. By offering a controlled, risk‑free, and agile learning ecosystem, this facility supports workforce confidence and reskilling with minimal risks. It provides a useful model for capability building that aligns with industry needs for continuous learning, digital fluency, and production readiness. This facility case study configuration is designed to create a practical framework for an agile environment, enabling data-driven decision-making, scalable, adaptable delivery models, and rapid talent development in the evolving landscape of advanced pharmaceutical manufacturing.
1400 – 1430
Sponsored Session
Patrick Traver, Arcadis
Jason King, Arcadis
This presentation makes the case that computational tools are most valuable when they amplify architectural judgment and subject matter expertise, not replace it. The session showcases how this human + computational partnership reshapes site master planning across the full arc of facility development, from initial site selection through detailed design and permitting. Attendees will see how computational processes support early, rapid feasibility analysis across multiple candidate sites, allowing architects to align site selection with business strategy, reduce risk, and safeguard capital expenditure before major decisions are locked in. The presentation will demonstrate how these tools help architects weigh multiple critical factors in parallel, including regulatory and GMP requirements, process and operational efficiency, and capital and schedule constraints, to produce site plans that are both defensible and functionally sound. The result is faster, more rigorous early-stage decision-making, with human expertise remaining central throughout. The session will highlight how this partnership adds value across multiple stages of master planning, serving as a bridge into subsequent design and permitting phases.
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
Governance - Risk - Readiness
Amanda McFarland, ValSource
James Wabby, AbbVie, Inc.
Fubin Wu, GessNet
Arie Menachem, Novo Nordisk
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.
1400 – 1430
Digital - Data - Decision Integrity
Tracy Hart, Siemens
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.
1430 – 1500
Governance - Risk - Readiness
William Hauck, Shabas Solutions LLC
Sarah Akers, Shabas Solutions LLC
Quality Management Maturity (QMM) represents a fundamental shift in how pharmaceutical operations are evaluated, from reactive compliance toward sustained excellence. This presentation shows how QMM drives comprehensive and proactive enterprise-wide transformation as compared to the traditional reactive approach by industry to only meet minimum cGMP compliance. Attendees will 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
Systems That Deliver Reliably
Justin Wagner, Flad Architects
Jeff Steinhauer, Flad Architects
Taylor Hill, Eli Lilly and Company
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
People - Capability - Workforce of Delivery
Anthony Tantuccio, Hovione LLC
Continuous manufacturing offers key benefits over batch operations, such as efficiency and agility, especially in commercial production. Early-phase development of oral solids, or continuous tableting, faces challenges like small volumes and limited API. Hovione’s CT201 facility addresses these with advanced technologies like Continuous Direct Compression, Wet Granulation, and PAT strategies. The road to operational maturity involved rapid upskilling and a shift from traditional sampling to modern monitoring, boosting efficiency and confidence. Today, CT201 matches batch efficiency for early programs and positions Hovione for future commercial gains. After three years, CT201 provides reliable, flexible clinical supply and demonstrates how continuous manufacturing translates theoretical advantages into operational reality.
1430 – 1500
Sponsored Session
Andreas Eschbach, Shiftconnector® - Eschbach USA and Germany
1430 – 1500
Digital - Data - Decision Integrity
Yiming Peng, Genentech Inc
Thomas O'Connor, PhD, GSK
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 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.
1430 – 1500
From Breakthrough to Bedside
Emnet Yitbarek, PhD, FDA/CBER
This presentation explores analytical method transfer (AMT) for biologics through a risk-based approach aligned with USP 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.
1500 – 1600
Networking
Refreshments offered, including non-alcoholic beverages and light snacks.
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
1600 – 1630
Digital - Data - Decision Integrity
Stephanie White, DayOne Pharma Consulting
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
Sponsored Session
MaryBeth Sukenick, Jacobs Engineering Group Inc
Steve Marley, Jacobs
Donald Fraser, Jacobs Engineering
Jorge Ferreira, Jacobs
As pharmaceutical manufacturing accelerates toward advanced therapies and grapples with real workforce constraints, today's facility decisions can lock in an operating model for decades. Most competitive discussions about the future of manufacturing focus on individual technologies — AMRs, cobots, AI — but the more consequential shift is architectural: these technologies only deliver value when facility design, material flow, digital infrastructure, and workforce strategy are planned together as one connected ecosystem, rather than bolted onto a building after the fact. This session introduces the Autonomous Production spectrum, a maturity model spanning today's human-driven logistics and manual material handling to tomorrow's self-directed, sensor-enabled production workflows. Attendees will explore why the industry is moving in this direction and what an autonomous facility actually looks like in practice, from automated material transport to the IT/OT architecture (MES, fleet management, environmental monitoring, enterprise systems) that lets independent systems act as one connected network. Attendees will leave with a practical framework for evaluating where their own facilities sit on the autonomy spectrum and how to design for flexibility rather than a costly retrofit.
1600 – 1630
Governance - Risk - Readiness
Kabir Ahluwalia, PhD, Amgen
Nina Cauchon, PhD, Amgen Inc.
This presentation examines how current post-approval change (PAC) frameworks, divergent global requirements, slow global uptake of ICH Q12, and inconsistent experience with post-approval change management protocols (PACMPs) delay pharmaceutical manufacturing expansion, especially site transfers, and increase supply chain vulnerability. Drawing on biologics and combination products, it will outline a risk continuum based on prior knowledge, process understanding, site experience, and prior transfer history, and discuss modernized expectations for PPQ, stability, comparability, earlier facility assessment, risk-based data expectations, and real-time sponsor-agency communication.
It will then discuss Amgen’s pioneering pilot to submit the first digitally generated CMC PAC dossier simultaneously to multiple health authorities using a single global dossier, structured content and data management, generative AI, cloud-based collaboration through the Accumulus platform, and PAC reliance. With the EMA serving as the reference health authority among 27 participating NRAs, 85% reached approval within 9 months.
The session will then explore AI use cases for a scalable reliance and collaboration process, including readiness and gap checks, intake support, question-response drafting, consistency checks, and analytics. It will also consider how structured data and ICH M16 will strengthen the speed, consistency, and scalability of regulatory dossier preparation and assessment while streamlining collaborative assessments and enhancing transparency.
1600 – 1630
People - Capability - Workforce of Delivery
Steven Chan, Gilead Sciences Inc
Capital projects in the pharmaceutical industry often stall between concept and sanction, as teams spend weeks developing scope, estimates, and business cases within governance requirements. These delays impact how quickly therapies reach patients. The root cause is not technology, but a capacity and judgment bottleneck. Early-stage decisions depend on experienced engineers, whose availability is limited. At Gilead, over 100 capital projects annually compete for this expertise. This session describes how Gilead implemented an AI-as-a-Service (AIaaS) capability within a GxP-compliant framework to support feasibility assessments and business case development. Delivered as a shared, on-demand service embedded in existing workflows, it provides consistent, decision-ready engineering insight at scale while maintaining traceability and auditability. Results were immediate: early-stage decisions were reduced from weeks to one day, senior engineering effort decreased, and more options were evaluated prior to sanction, improving capital allocation. By scaling engineering judgment into an enterprise service, this approach increases speed, consistency, and portfolio throughput—offering a practical, compliant model for AI adoption in regulated environments.
1600 – 1630
From Breakthrough to Bedside
Christian Estes, IPS
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.
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.
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. Through scale-up of its continuous roll-to-roll manufacturing process, Liquidia has translated PRINT from a development-stage technology into a commercially viable pharmaceutical manufacturing platform. 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.
1630 – 1700
People - Capability - Workforce of Delivery
Richard Jaenisch, Open Biopharma Research and Training Institute
The integration of AI in life sciences is poised to contribute significant value to the sector. One primary barrier is a mismatch in human capability with available technology. Organizations that fail to address this knowledge gap could face regulatory risks under the EU AI Act, potential intellectual property loss, poor ROI on their AI implementations, and/or talent departure. This presentation details the ISPE AI CoP’s Life Sciences AI Literacy Level Framework, which consists of levels 0-6, with some parallel paths for different kinds of use across technical and business functions. Each level not only indicates what should be understood, but also indicates the minimum level that roles should consider developing their AI expertise to. The session covers how this framework can benefit you as an individual, as an organization, or as a team. It will go over how the framework was developed and its considerations. Importantly, it also allows people to better understand what they need to know for the work they’re doing. It allows organizations to know beforehand if and where they should put AI into practice. The Levels are a constantly evolving framework that welcomes your voice in our working group and uses those insights to update annually.
1630 – 1700
Governance - Risk - Readiness
Jean-Pierre Doan, Merck KGaA
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 Authorities, governance remains the critical missing layer for the moment. Technology has outpaced the legal, institutional, and operational frameworks needed to make such collaboration inspectable, accountable, and scalable. This presentation examines a case-study scenario of a cloud collaboration environment involving a trusted multiparty operator and multilateral governance mechanism.
The scenario explores four governance aspects:
- legal frameworks beyond contractual terms;
- IP ownership, data sovereignty, and liability;
- programmable, consensus-driven decision-making; and
- auditable trust through cryptographic verification and on-demand compliance reporting.
The session concludes with a set of governance directions for further exploration and supports discussion among industry and regulatory stakeholders on how to address the governance blind spot in regulatory cloud collaboration: how to move from pilots to practice.
1630 – 1700
Digital - Data - Decision Integrity
Martin Heitmann, MH Consulting & Advisory GmbH
Oliver Herrmann, QFINITY Quality Management
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
Sponsored Session
JP Bornholdt, Autodesk
Justin Dewell, Pfizer
This session explores new ways industry leaders are leveraging data and collaboration across global networks to maximize operational success. Discover how governing your data and connecting your workforce boosts efficiency, accelerates growth, and sets the foundation for continuous improvement at every stage of your facility lifecycle. We will reveal the insights and tools leading pharmaceutical companies are implementing to meet market demand and position their global manufacturing networks for lasting success.
1630 – 1700
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.
1700 – 1730
People - Capability - Workforce of Delivery
Melissa Balmer, Merck & Co Inc
Sarah Botham, CRB
As AI becomes integrated in our daily workflows, and automated validation tools become more common, training is often geared towards the implementation and use of new technologies. Weak User Requirement Specification (URS) practices do not disappear with digital tools—they are amplified by them. The incorporation of technology makes the quality of upstream human-defined requirements even more critical; AI can’t sit at the table and defend decisions to an auditor. Questions regarding requirement traceability, e.g., “How did you test this requirement?” or “Why did you decide that requirement didn’t need to be met?,” require a real human to be held accountable. URS documents carry a lot of weight in the capital project process and when time and cost pressures impact their quality, they lose their value as tools. They often contain too many requirements, untestable requirements, or copy/paste errors from other documents. In some cases, the URS was not written until after the equipment was purchased! The industry needs to get back to basics and restore value to the URS as a tool. This presentation intends to offer guidance on writing URS documents that help with design, procurement, commissioning, and how/when to modify the requirements mid-project to minimize potential deviations.
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.
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
Governance - Risk - Readiness
Gaurav Walia, PQE Group
John Clapham, PSC Biotech Corporation
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 session closes that gap.
Speakers will walk through a structured playbook framework covering seven key areas: intended use, GxP and data classification, data flow, documentation structure, lifecycle and monitoring, release management, and access controls. Drawing on real-world examples and lived inspection experience, speakers will illustrate what a complete, inspection-ready AI narrative looks like across all seven dimensions.
Speakers with live AI deployments will share what they actually had prepared going into their last inspection or audit, and what they wish they had ready, grounding the framework in real experience rather than theory.
Speakers will walk through a structured playbook framework covering seven key areas: intended use, GxP and data classification, data flow, documentation structure, lifecycle and monitoring, release management, and access controls. Drawing on real-world examples and lived inspection experience, speakers will illustrate what a complete, inspection-ready AI narrative looks like across all seven dimensions.
Speakers with live AI deployments will share what they actually had prepared going into their last inspection or audit, and what they wish they had ready, grounding the framework in real experience rather than theory.
1700 – 1730
This 30-minute session will explore how pharmaceutical and biopharmaceutical manufacturers can move beyond traditional automation toward autonomous, data-centric manufacturing operations. As organizations face increasing pressure to improve productivity, quality, compliance, and supply chain resilience, the next competitive advantage will come from connected, contextualized, and trusted data architectures that enable smarter decision-making across manufacturing, quality, engineering, facilities, and supply chain functions.
Drawing on Schneider Electric's latest global manufacturing research, Neil will share insights into how Life Sciences leaders are approaching autonomous operations and why they are becoming a strategic priority. The session will highlight the key capabilities required to support this transformation, including:
- Unified data architectures and semantic data models
- Digital twins and software-defined automation
- Edge computing and AI-enabled operations
- Open, interoperable technology ecosystems
Attendees will gain a practical understanding of how these capabilities can simplify compliance, improve data integrity, support review-by-exception processes, reduce manual intervention, and enable future innovations such as real-time release, predictive quality, and autonomous process optimization. The session will also showcase real-world examples from the Life Sciences industry, demonstrating how manufacturers are connecting enterprise systems, electronic batch records, process historians, environmental monitoring systems, building management platforms, and manufacturing equipment to create a unified operational view across sites and functions.
Participants will leave with actionable insights into the technology, data, and organizational foundations required to accelerate their journey from digital transformation to autonomous manufacturing, while strengthening quality, compliance, operational resilience, and readiness for the next generation of AI-driven innovation.
1700 – 1730
From Breakthrough to Bedside
Emily Heffernan, Arcadis US
Nigel Stevenson, PhD, Exubrion Therapeutics
Radiopharmaceuticals have emerged as a treatment option for oncologic indications by enabling precise, targeted delivery of radioisotopes to malignant cells. While most treatments focus on human medicine, non-oncologic, veterinary applications are also in development. In this joint presentation with Exubrion Therapeutics, a pioneer in veterinary radiopharmaceuticals, we will explore the unique manufacturing, supply chain, and facility design challenges associated with bringing these advanced therapies to market. Key considerations include the manufacturing and processing of radioisotopes focusing on safety, efficacy, and operational risk. The inherently short half-lives of radioisotopes demand efficient logistics and aseptic manufacturing to ensure product quality and patient safety. Understanding the full half-life profile for effective radiation protection measures and waste management requirements is also critical. We will highlight the distinct requirements for veterinary products, where scale, regulatory landscapes, and facility design may differ from human applications. Importantly, the facility design incorporates flexibility to support potential future human indications, enabling scalable operations and compliance across therapeutic areas. By presenting a case study of Exubrion Therapeutics’ manufacturing facility, we will illustrate how strategic decisions such as sourcing versus in-house production of radioisotopes impact supply chain resilience, cost, and facility complexity.
1730 – 1900
Networking
Connect with industry leaders at our Welcome Reception. Enjoy food and beverages in the Expo Hall while networking with exhibitors and attendees.
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
1930 – 2200
Join the Women in Pharma® signature Monday Night Networking Event, returning in 2026 with this year's inspiring theme: Mission: Possible — ISPE Women in Pharma Breaking Boundaries. Connect with professionals from across the pharmaceutical industry for an evening of dinner, meaningful networking, engaging conversation, and community. This special on-site event is designed to help attendees build valuable relationships, exchange ideas, and celebrate the impact of women and allies who are driving innovation and progress across the industry. Whether you're reconnecting with colleagues or meeting new peers, you'll enjoy an interactive, welcoming environment that encourages authentic connections beyond the traditional reception experience. Separate registration and fee required. Limited capacity. Sponsored by AstraZeneca.
0700 – 1800
0700 – 0800
0815 – 0845
The pharmaceutical industry is on the cusp of a transformative era, driven by advancements in technology and innovative approaches to facility design and operation. This will all improve the safety of our operations, improve our quality performance, and advance our ability to scale and reach more patients with life saving medicine.
This presentation will explore some of Lilly’s examples to advancing our Manufacturing Innovation agenda to reach more patients and will include aspects such as Facilities of the Future elements in Lilly’s investment agenda, advancing technology & standardization in our manufacturing processes to enhance operational excellence, and our people investment plans building capability and unleashing our employees’ potential for the future.
Key topics will include:
Manufacturing innovation with new facilities
Examples in our Device and Packaging operations leveraging technology
Leveraging Standardization to accelerate performance
People investment plans to build capability
0845 – 0915
General Session
Bill Reid, Google
As the life sciences sector transitions from static, deterministic software to highly autonomous, agentic artificial intelligence, industry leaders face a critical challenge: how to validate and govern systems that operate probabilistically rather than sequentially. This keynote reframes the AI alignment debate by demonstrating that the pharmaceutical industry has safely managed highly complex, non-deterministic agents for over a century: human beings. By exploring the profound operational parallels between traditional Quality Management Systems (QMS) and modern cybersecurity principles, this session challenges quality assurance and security leaders to think differently about the shared mission of trust and patient safety. Rather than searching for entirely new validation paradigms, we will discuss how to adapt our proven, consensus-driven human governance frameworks to autonomous systems—equipping you to lead the industry-wide dialogue that turns rapid technological change into responsible, compliant progress.
0915 – 0930
General Session
John Birkmire, Barry-Wehmiller Design Group
0930 – 1545
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
0930 – 1030
Networking
Refreshments offered, including non-alcoholic beverages and light snacks.
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
0930 – 1545
Take a break and enjoy a friendly game of pickleball in the Expo Hall! The two courts are open Monday, 0930–1900, and Tuesday, 0930–1545. Participation is free, and attendees can sign up in person at the pickleball courts by completing the waiver. If you plan to play, you may wish to bring a change of clothes and/or athletic shoes for added comfort.
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 – 1100
Sponsored Session
Bethany Silva, Endress+Hauser
Beyond Measurement: Leveraging Smart Instrument Diagnostics to Reduce Downtime and Improve Reliability
As pharmaceutical manufacturers strive to increase productivity, reduce operational risk, and optimize maintenance resources, smart instrumentation is emerging as a valuable source of actionable operational intelligence. Modern instruments generate far more than process measurements. They provide continuous diagnostics, health indicators, and device status information that can be leveraged to improve asset reliability and support data-driven maintenance strategies. This presentation will explore how manufacturers can transform instrument diagnostics into meaningful operational insights through condition monitoring, predictive maintenance, and visualization tools. Attendees will learn how connected instrumentation and IIoT-enabled data platforms can help identify developing issues before they impact production, reduce unplanned downtime, and support more efficient maintenance practices.
As pharmaceutical manufacturers strive to increase productivity, reduce operational risk, and optimize maintenance resources, smart instrumentation is emerging as a valuable source of actionable operational intelligence. Modern instruments generate far more than process measurements. They provide continuous diagnostics, health indicators, and device status information that can be leveraged to improve asset reliability and support data-driven maintenance strategies. This presentation will explore how manufacturers can transform instrument diagnostics into meaningful operational insights through condition monitoring, predictive maintenance, and visualization tools. Attendees will learn how connected instrumentation and IIoT-enabled data platforms can help identify developing issues before they impact production, reduce unplanned downtime, and support more efficient maintenance practices.
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
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.
1030 – 1100
From Breakthrough to Bedside
Hanh-Uyen Nguyen, Multiply Labs
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
People - Capability - Workforce of Delivery
Jan Botthof, PhD, BlueRock Therapeutics
ATMPs such as cell therapies bring unique complexities, with novel manufacturing paradigms and a rapidly evolving regulatory landscape. Building a phase-appropriate Quality Culture is a key capability every company must master to scale therapies from early development to the clinic and market. To succeed, Quality Culture must shift from a gatekeeping exercise to a critical enabler. We demonstrate how to find the right level of rigor without sacrificing the speed and agility required as we progress through development. This talk outlines BlueRock's ongoing Quality Culture journey: how we are evolving our mindset, skillset, and toolset within Tech Ops and Quality to ensure compliance remains both phase-appropriate and agile. We will share practical examples of how we drive these changes, including the introduction of a fit-for-purpose Quality Toolkit, targeted upskilling programs, and culture initiatives to establish the right Quality mindset. Finally, we will share experiences on how this Culture Change is driving performance across the organization, affecting everything from daily operations to investment projects.
1100 – 1130
Digital - Data - Decision Integrity
Rod Hoffman, AstraZeneca
Christian Woelbeling, Körber Pharma Software GmbH
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
Sponsored Session
Nick O'Hare, ARCO
Josh Lamb, ARCO Design/Build
Every facility type carries its own technical constraint. Radiopharmaceutical projects contend with short product shelf life, shielding requirements, and regulatory approvals that run on their own timeline alongside construction. Monoclonal antibody expansions are governed by capacity assumptions that must survive well beyond the original design. Fill/finish is shaped by contamination control and evolving Annex 1 expectations. Cold chain logistics facilities are driven by temperature integrity and distribution requirements that reach back into building design. The constraints look nothing alike, but the failure points do. Across all four, projects go off track in the same places: an end state defined too late, sites selected or existing facilities evaluated before operational requirements are understood, equipment and vendors engaged after the design they should have informed, and change absorbed during construction rather than resolved in preconstruction.
Drawing on delivered projects across these facility types, this session examines what transfers between modalities and what does not. What real projects teach about site selection, existing facility evaluation, and early equipment/vendor coordination before costly decisions are locked in applies well beyond any single modality. Radiopharmaceutical projects serve as the stress case, where compressed schedules and unforgiving sequencing expose weaknesses that other facility types can absorb, and those lessons are applied back to more familiar builds. Attendees will leave with a practical framework for identifying where their next project is most exposed, regardless of what it manufactures.
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.
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
Systems That Deliver Reliably
William Lucas, Blue Mountain
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
People - Capability - Workforce of Delivery
Anil Mathai, Global Light Enterprise LLC
This session is an extension of the 2025 ISPE Annual Meeting presentation and blog, "Navigating FDA Compliance: 7356.002 and QMS Success in Outsourcing Facility Inspections". While that session established the regulatory framework and summarized FDA observation trends specific to 503B facilities, this session moves from what is being found to what to do about it, and who needs to be ready. Building on that foundation, this presentation translates the most frequently cited 503B deficiency areas into actionable prevention and remediation strategies. Aseptic processing controls, environmental monitoring gaps, personnel qualification shortfalls, batch record integrity issues, and supplier qualification failures are not just inspection findings. They are predictable outcomes of quality system weaknesses and capability gaps that can be identified and corrected before an investigator walks through the door.
People capability is central to this framework. Sustainable inspection readiness depends on teams that understand their role, execute under pressure, and are developed intentionally rather than reactively. This session addresses how lean 503B operations build that capability through structured competency development, clear role ownership, and scalable training models. Attendees leave with practical tools to close recurring gaps, embed readiness into daily practice, and develop the workforce confidence that holds up when oversight intensifies.
People capability is central to this framework. Sustainable inspection readiness depends on teams that understand their role, execute under pressure, and are developed intentionally rather than reactively. This session addresses how lean 503B operations build that capability through structured competency development, clear role ownership, and scalable training models. Attendees leave with practical tools to close recurring gaps, embed readiness into daily practice, and develop the workforce confidence that holds up when oversight intensifies.
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
People - Capability - Workforce of Delivery
Kathy Zielinski, Hoffmann-La Roche Limited
AI-enabled tools are entering GxP environments faster than inspection readiness frameworks can keep pace. When a health authority arrives, the questions are real, the gaps are visible, and the pressure falls on specific people in specific roles. This workshop prepares participants for that moment. Attendees are assigned to one of four SME roles: Quality Unit, Business/Process Owner, IT System, or AI Sub-system. Using a realistic GxP scenario involving an AI-enabled decision support tool, each group prepares their portion of the inspection response, then the room comes together as a unified team. Facilitators probe with real inspection-style questions, and the debrief surfaces exactly where role clarity breaks down and where documentation gaps would show up under scrutiny. This is not a lecture on AI governance frameworks. It is a rehearsal. Participants experience the pressure of inspection-style questioning, identify where their organization's narrative would hold and where it would not, and leave with a clearer picture of what cross-functional inspection readiness requires.
1130 – 1200
Equipment cleaning concerns are often overlooked during design, startup, and commissioning of biopharmaceutical facilities. Failures to understand cleaning agent selection, critical cleaning parameters, drug product degradation, and analytical method selection can lead to costly delays in the process. Technical transfer teams and regulatory agencies expect laboratory testing to support the cleaning validation lifecycle approach. Novel drug products such as antibody drug conjugates (ADC) can present unique cleaning challenges based on the toxicity of the drug and degradation profile of the drug product. This presentation will explore monoclonal antibody (mAb), highly potent active pharmaceutical ingredient (HPAPI) and antibody drug conjugate (ADC) laboratory case studies incorporating routine cleaning evaluation and drug product degradation using techniques such as visual inspection, total organic carbon (TOC), high performance liquid chromatography (HPLC) and enzymatic activity assays. The presentation will assess if product degradation is preferred, the analytical methods to support lab and at scale testing and approaches to bridge lab and at scale studies.
1130 – 1200
Governance - Risk - Readiness
Emily Thakur, CDR, FDA
Djamila Harouaka, CDER/OPQ/OQS/FDA
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.
1130 – 1200
Digital - Data - Decision Integrity
Khaled Moussally, Compliance Group Inc
Louie Rayal, PhD, GSK UK
Daniel Walter, FDA/CDRH
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
- Life sciences organizations are investing more than half a billion dollars in capital projects in the United States alone, from building new manufacturing facilities to expanding site capabilities.
- Successful delivery depends on how these capital programs are planned and coordinated across a life cycle that involves multiple internal teams and external vendors.
- This panel will explore the challenges organizations face, from early capital planning and basis of design through design, construction, commissioning and qualification, and site readiness.
- Speakers will discuss practical ways to accelerate delivery while supporting quality, compliance, operational readiness, and business value.
- We will also explore digital tools and governance frameworks that can be used to accelerate capital program delivery and help the site remain digitally native from day one.
- The session will bring together perspectives from capital project leaders and EPCM (engineering, procurement, and construction management) organizations to address what it takes to move from capital investment to a fully ready, digitally native, high-performing life sciences facility.
1200 – 1415
The ISPE Membership Meeting and Awards Lunch is open to all ISPE members and education attendees, including those with an In-Person All Access Pass and the Tuesday One-Day Education Pass. 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. The virtual live stream will begin at 1245 ET and will be available to access on the virtual conference platform.
1415 – 1545
Networking
Satisfy your sweet tooth and mingle with industry peers at our delightful Dessert Reception, all served in the vibrant ambiance of the Expo Hall.
Engage with over 275 exhibitors and participate in the following activities while visiting the Expo Hall:
- Join and/or renew your ISPE membership and learn more about ISPE Lumen, member benefits, meet with the Chesapeake Bay Area Chapter and more at the ISPE Booth #825
- Attend Spotlight Sessions and learn more about ISPE Guidance Documents at the ISPE PUBlications Lounge, Booth #349
- Using the ISPE Mobile App, participate in the Giveaway Game for a chance to win a prize by visiting all exhibitor booths
- Learn more about the ISPE Facility of the Year Award (FOYA) program and leverage your chance to meet with the winners, judges, and others involved at the FOYA Booth #537
- Discover and explore new career opportunities at the ISPE Career Center and leverage your chance to update your professional headshot at Booth #200
- Visit the Pickleball Zone to participate or watch a friendly game of Pickleball at Booth #1205
- Book your Expo Hall space for the 2027 ISPE Annual Meeting & Expo at the ISPE Sales Office, Booth #1101
- Get a firsthand look at the size and engineering behind modern biopharmaceutical manufacturing at the ABEC 17-Foot Bioreactor, Booth #549
- Experience how the physical and digital worlds come together though guided demonstrations, real-world use cases and virtual and augmented reality at the Siemens eXplore Trailer, Booth #201
- Get an up-close look at the cleanroom design, environmental controls, and equipment placement at the Germfree Mobile Cleanroom Trailer, Booth #1350
1545 – 1630
Digital - Data - Decision Integrity
Kent Abrahamson, AbbVie
Alan Stevens, AbbVie
The presentation will describe technical and regulatory strategies for implementing a platform device. Key discussion topics will include technical content, regulatory challenges, bridging strategies, and future policy developments in platform devices. Central to platform approach is a modular approach to development, including platform data, platform control strategy, bridging and combination product modules. Platform data is centered on development and execution of an operational design space that verified performance of the platform device across a wide-array of potential drugs. Platform control strategy focuses on elements of manufacturing quality that can be reused across multiple products. Bridging module is key to strategic use of platform information for specific combination products. Combination product module represents product-specific requirements that must be verified and validated by the platform. Future policy development includes generating industry developed standards for how to implement a platform device.
1545 – 1630
From Breakthrough to Bedside
Ramjay Vatsan, PhD, CBER/FDA
Regulation of Cell and Gene Therapy Products: An Overview of FDA’s Current Guidances and Recommendations
This talk will provide an overview of FDA regulated Cell and Gene therapy products and discuss FDA’s recent CMC guidances in this field.
This talk will provide an overview of FDA regulated Cell and Gene therapy products and discuss FDA’s recent CMC guidances in this field.
1545 – 1615
Documentation delays of four to twelve weeks are common on complex pharmaceutical and biopharma capital projects, and first-pass turnover pack rejection runs as high as 40–60% where there's no dedicated system for capturing it as the work happens. One third of what inspectors write up at pharma facilities relates to documentation — often years after the contractors who built the facility are gone. This session looks at a new way of closing that gap: anchoring punches, document links and test packs directly to tags on the P&ID itself, so they're captured the moment the work happens instead of chased down afterwards. When a revision is issued, markups and punches carry forward with it - removing rework at exactly the point it has always crept back in. Drawing on sixteen years of construction and commissioning experience across pharmaceutical, biopharma and semiconductor builds — including projects for Merck, Pfizer and Lilly - Dan will walk through what this looks like in practice: a live drawings dashboard organised by system, automatic tag recognition that removes manual re-entry, and a documentation record built to survive not just handover, but the twenty to thirty years a facility operates afterward. Attendees will leave with a practical way to assess where their own projects are most exposed to documentation and revision-management risk, and a concrete example of what real-time, tag-level capture looks like on a live pharmaceutical build.
1545 – 1630
People - Capability - Workforce of Delivery
Jörg Zimmermann, Vetter Pharma Fertigung GmbH & Co KG
Vetter has created a dedicated, highly integrated training ecosystem centered around the new Vetter Training Centre — an operational hub that enables safe, hands-on learning across all relevant pharmaceutical and analytical processes. Through full scale simulation environments, including compounding rooms, laboratories, and a pilot scale technical area, Vetter qualifies new employees outside of live GMP operations. This approach allows learners to build practical experience with aseptic workflows, analytical instrumentation, digital documentation, and automation technologies before entering regulated manufacturing. These strategic investments were made in response to the fast‑changing labor market in the pharmaceutical industry. Increasing product complexity, growing automation, demographic shifts, and rising global demand have led to a noticeable shortage of skilled technical and scientific professionals. By recognizing this trend early, Vetter positioned itself to build a sustainable talent pipeline, strengthen supply resilience, and help its workforce stay ready for the increasing demands of modern pharmaceutical manufacturing.
1545 – 1630
Systems That Deliver Reliably
Drew Zahradka, WB Engineers + Consultants
Chad Melton, Solvias North America LLC
Raymond Doyle, WB Engineers+Consultants
This session explores how LEED-driven design strategies can be applied within an active GxP environment to improve facility performance and reliability. Through a laboratory retrofit case study, the presentation will demonstrate how sustainability objectives were integrated into core engineering and operational decisions without compromising manufacturing activities. Rather than a full system replacement, the project focused on optimizing existing infrastructure through targeted upgrades, including VRF integration, DOAS with energy recovery, enhanced commissioning, and advanced energy metering. These strategies supported improved system performance and operational flexibility while aligning with LEED certification goals. Attendees will gain insight into how sustainability frameworks such as LEED can be used as a tool for informed decision-making. The session will highlight how facility and engineering teams can apply similar approaches to enhance reliability and scalability in regulated manufacturing environments.
1545 – 1630
Governance - Risk - Readiness
Eilis Kelly, Johnson & Johnson
David Estapé, PhD, CRB Group GmbH
Leaks during pharmaceutical manufacturing are unfortunate but not uncommon, particularly when single- use components are used. In aseptic or sterile operations, even minor leaks can result in batch rejection because of the perceived contamination risk and the inability to definitively prove that contamination did not occur. Currently, whenever a leak occurs, companies conduct thorough investigations to confirm product quality (e.g. sterility). But what if there were a high level of certainty that contamination would not occur? We would not always need to assume the worst and even neglect the risk of contamination. This would mean shifting away from today’s more rigid quality thinking, which often relies on perceived risk. Instead, making decisions would focus on thoughtful simple risk analysis of a leak event, science and data driven. Our presentation opens the door to a new way of thinking about leak management. It reflects ongoing discussions among industry experts at BioPhorum, exploring the impact of leaks on product quality and the supply chain. Adopting this new perspective requires open dialogue, challenge, and buying across the pharmaceutical community. We invite you to join this conversation.
1630 – 1700
Sponsored Session
Thomas McCarthy, AVEVA
Life sciences capital delivery is entering an unprecedented build cycle, yet "business as usual" practices continue to undermine schedule predictability and cost performance. Today's siloed project execution and functional handoffs across the tech transfer lifecycle further create avoidable friction, rework, and compounding technical debt.
The session targets the most common breakdowns in today’s delivery and tech transfer practices, including handover discontinuity, megaproject unpredictability, lack of repeatability, GMP/non‑GMP fragmentation, vendor interface walls, and interoperability barriers driven by inconsistent information models.
Attendees will leave with 5 key takeaways; each framed as a paired set of behaviors: "stop doing / start doing. Together, these 10 do’s and don’ts translate digital continuity from an abstract aspiration into concrete execution decisions and day-to-day practices. These behaviors are not theoretical suggestions; they reflect proven approaches used in other industries that life sciences must adopt to fully capture the value of the current build cycle and shift the operating mindset.
The session targets the most common breakdowns in today’s delivery and tech transfer practices, including handover discontinuity, megaproject unpredictability, lack of repeatability, GMP/non‑GMP fragmentation, vendor interface walls, and interoperability barriers driven by inconsistent information models.
Attendees will leave with 5 key takeaways; each framed as a paired set of behaviors: "stop doing / start doing. Together, these 10 do’s and don’ts translate digital continuity from an abstract aspiration into concrete execution decisions and day-to-day practices. These behaviors are not theoretical suggestions; they reflect proven approaches used in other industries that life sciences must adopt to fully capture the value of the current build cycle and shift the operating mindset.
1630 – 1715
People - Capability - Workforce of Delivery
Rachel Fournier, Vera Therapeutics
Nathan Jack, Syner-G
As pharmaceutical manufacturing organizations accelerate toward AI-enabled, continuous, and personalized production models, technological innovation is outpacing workforce readiness. Many initiatives struggle not because the technology is insufficient, but because organizations lack the processes, digital acumen, and integrated systems required to operate effectively in complex, regulated, AI-augmented environments.
This presentation reframes AI transformation as an enterprise and workforce challenge rather than a purely technological one. It explores common barriers to adoption, including ambiguity around AI, fear of workforce displacement, regulatory uncertainty, and misalignment in how work is designed between humans and technology.
Drawing from a global medical device manufacturer’s AI transformation journey, this session introduces a practical framework grounded in three principles: people first, processes that work, and technology that is fit-for-use. Attendees will gain insight into emerging digital roles and skillsets, approaches to effective human–AI collaboration, and methods for assessing workforce readiness through performance, adoption, and cultural confidence.
The session concludes with actionable guidance for building a resilient, AI-augmented workforce capable of supporting scalable, compliant, and innovation-driven manufacturing.
This presentation reframes AI transformation as an enterprise and workforce challenge rather than a purely technological one. It explores common barriers to adoption, including ambiguity around AI, fear of workforce displacement, regulatory uncertainty, and misalignment in how work is designed between humans and technology.
Drawing from a global medical device manufacturer’s AI transformation journey, this session introduces a practical framework grounded in three principles: people first, processes that work, and technology that is fit-for-use. Attendees will gain insight into emerging digital roles and skillsets, approaches to effective human–AI collaboration, and methods for assessing workforce readiness through performance, adoption, and cultural confidence.
The session concludes with actionable guidance for building a resilient, AI-augmented workforce capable of supporting scalable, compliant, and innovation-driven manufacturing.
1630 – 1715
From Breakthrough to Bedside
Warren Roche, PhD, Argenx / BlueSigma
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 behavior 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.
1630 – 1715
Digital - Data - Decision Integrity
Ram Sathia, Infiligence
Arvind Govindarajan, AuraGXP
AI-Assisted Verification & Validation for Software as a Medical Device: Accelerating Compliance While Maintaining Regulatory Rigor.
Software as a Medical Device (SaMD) development faces a critical challenge: balancing rapid innovation with stringent verification and validation requirements under FDA 21 CFR Part 820, IEC 62304, and ISO 13485. Traditional V&V approaches, while thorough, often consume 40-60% of development timelines and struggle to adapt to AI/ML-enabled medical devices that continuously evolve. This presentation introduces a practical framework for AI-assisted V&V that maintains full regulatory compliance while significantly reducing validation cycle times. Our approach integrates artificial intelligence capabilities into traditional V&V workflows across four key areas:
LEARNING OBJECTIVES
At the end of this presentation, attendees will be able to:
Software as a Medical Device (SaMD) development faces a critical challenge: balancing rapid innovation with stringent verification and validation requirements under FDA 21 CFR Part 820, IEC 62304, and ISO 13485. Traditional V&V approaches, while thorough, often consume 40-60% of development timelines and struggle to adapt to AI/ML-enabled medical devices that continuously evolve. This presentation introduces a practical framework for AI-assisted V&V that maintains full regulatory compliance while significantly reducing validation cycle times. Our approach integrates artificial intelligence capabilities into traditional V&V workflows across four key areas:
LEARNING OBJECTIVES
At the end of this presentation, attendees will be able to:
- Describe how AI-assisted methods can accelerate SaMD verification and validation while maintaining regulatory compliance with FDA 21 CFR Part 820, IEC 62304, and ISO 13485
- Identify key integration points between AI capabilities and traditional V&V workflows, including automated traceability, risk-based test generation, and continuous validation monitoring
- Apply a risk-based assessment framework to evaluate AI-assisted V&V adoption for their medical device software development programs
- Recognize critical quality system considerations, regulatory defensibility requirements, and implementation best practices for AI-assisted validation approaches
1630 – 1715
Systems That Deliver Reliably
Regina Donaldson, Bayer U.S., LLC
Jasmin Rajak, Fluor Life Sciences
Leading with Purpose: Strategic and Innovative Sustainability Execution for a LEED Platinum Project
Implementing sustainability practices and achieving green building certification for Life Science (LS) projects is not only achievable but increasingly essential. This shift is driven by corporate ESG objectives, regulatory requirements, environmental stewardship, and a commitment to responsible corporate citizenship. Co-presented by Bayer (Owner) and Fluor (EPCM provider), this session will showcase the sustainability execution strategies and innovative solutions that led to Bayer’s Cell Therapy Facility in Berkeley becoming the first LEED v4 Platinum–certified industrial manufacturing facility in the western United States. The presentation will highlight key impact areas, challenges, and the tangible benefits realized through the delivery of a resilient, sustainably operable facility.
Implementing sustainability practices and achieving green building certification for Life Science (LS) projects is not only achievable but increasingly essential. This shift is driven by corporate ESG objectives, regulatory requirements, environmental stewardship, and a commitment to responsible corporate citizenship. Co-presented by Bayer (Owner) and Fluor (EPCM provider), this session will showcase the sustainability execution strategies and innovative solutions that led to Bayer’s Cell Therapy Facility in Berkeley becoming the first LEED v4 Platinum–certified industrial manufacturing facility in the western United States. The presentation will highlight key impact areas, challenges, and the tangible benefits realized through the delivery of a resilient, sustainably operable facility.
1630 – 1715
Governance - Risk - Readiness
Andrew Cieri, Regeneron
QMS Anticipates CGT Challenges: Phase-Appropriate and Risk-Based Quality Assurance Strategies for Phase 1 Autologous Cell and Gene Therapy Drug Products
The development of cell and gene therapy (CGT) products brings unique challenges, particularly during Phase 1 GMP manufacturing, where patient safety, product quality, and regulatory compliance must be ensured despite limited clinical data and process variability. These challenges are compounded in scenarios involving a company acquisition, where integration of quality systems, alignment of organizational cultures, and harmonization of operational priorities add layers of complexity. To address these multifaceted issues, implementing phase-appropriate and risk-based quality assurance (QA) strategies becomes essential. This presentation will explore the design and execution of QA strategies tailored to the distinct requirements of an internally manufactured CGT drug product for Phase 1 clinical trial while navigating challenges arising from both external and internal changes.
The development of cell and gene therapy (CGT) products brings unique challenges, particularly during Phase 1 GMP manufacturing, where patient safety, product quality, and regulatory compliance must be ensured despite limited clinical data and process variability. These challenges are compounded in scenarios involving a company acquisition, where integration of quality systems, alignment of organizational cultures, and harmonization of operational priorities add layers of complexity. To address these multifaceted issues, implementing phase-appropriate and risk-based quality assurance (QA) strategies becomes essential. This presentation will explore the design and execution of QA strategies tailored to the distinct requirements of an internally manufactured CGT drug product for Phase 1 clinical trial while navigating challenges arising from both external and internal changes.
1900 – 2300
Networking
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
0800 – 0900
0800 – 1300
0910 – 0940
The Pharmaceutical Inspection Co-operation Scheme: Quality, Standards, Capability, Harmonization, Confidence & Collaboration
0940 – 1010
General Session
Marla Phillips, Pathway for Patient Health LLC
As pharma races to adopt AI, the industry has quietly accepted a backwards premise—that the algorithm runs the process and the human is merely “in the loop” to check its work. This keynote flips that logic: the human commands the AI—deciding where it belongs and how it’s validated—and that command is exactly what unleashes people to make more informed decisions than ever before. Drawing on the power of “why” and lessons from high-reliability industries like nuclear power, Phillips will prove that when people command AI rather than rubber-stamp it, they aren’t sidelined—they’re amplified, and patients gain the last, best safeguard of a human who truly understands the decision.
1010 – 1030
1030 – 1145
General Session
Raphael Sanches Pereira, Anvisa
Benjamin Stevens, Alnylam
Martin Heitmann, MH Consulting & Advisory GmbH
Victor Bechmann, Danish Medicines Agency (DKMA)
Sarah Johnson, FDA
Sarah Pope Miksinski, PhD, Takeda
Mahesh Ramanadham, FDA/CDER/OPQ/OPPQ
Ashley Boam, FDA/CDER/OPQ/OPPQ
Tami Frederick, PAI Pharma
From Snapshots to Surveillance: How Data, Maturity and AI are Re-shaping Quality and Compliance
The relationship between pharmaceutical regulators and manufacturers is being redefined on two fronts. Artificial intelligence is moving rapidly from pilot to production across development, CMC, dossier preparation, manufacturing, and distribution — and into the inspection and assessment practices of the authorities themselves. Regulators are converging on a shared expectation: that AI, wherever it is used in regulated contexts, must be credible, controlled across its life cycle, and transparently governed. In parallel, health authorities are piloting new ways to demonstrate and reward quality maturity—shifting from point-in-time compliance assessments toward evaluation of the sustained maturity of quality systems, with the potential to accelerate approvals, reduce regulatory friction, and strengthen supply chain resilience. This town hall convenes senior representatives from global health authorities and industry leaders to explore both themes to discuss how technology and engagement can accelerate safe, sustainable delivery of therapies to patients.
Raphael Sanches Pereira
Health Regulation and Surveillance Specialist
Anvisa
Anvisa
Benjamin Stevens
Senior Director of CMC Policy & Advocacy
Alnylam
Alnylam
Martin Heitmann
Managing Director
MH Consulting & Advisory GmbH
MH Consulting & Advisory GmbH
Victor Bechmann
Medicines Inspector
Danish Medicines Agency (DKMA)
Danish Medicines Agency (DKMA)
Sarah Johnson
Regulatory Specialist, CDER
FDA
FDA
Sarah Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Takeda
Takeda
Mahesh Ramanadham
Deputy Director
FDA/CDER/OPQ/OPPQ
FDA/CDER/OPQ/OPPQ
Ashley Boam
Director, Office of Policy for Pharmaceutical Quality, OPQ
FDA/CDER/OPQ/OPPQ
FDA/CDER/OPQ/OPPQ
Tami Frederick
Vice President, Quality
PAI Pharma
PAI Pharma
1145 – 1200
General Session
1200 – 1215
General Session
0800 – 1300
SOLD OUT!
Note: Attendees are required to have their conference badge to access all ISPE events and activities. Buses will depart from the Gaylord National Resort & Convention Center at 08:00 ET, returning around 1300 ET.
During the tour, participants will see Manufacturing and Quality Control in action through our uniquely designed facility, which allows observation of the Manufacturing and Quality Control laboratories through glass. The tour will cover the technology and analytical methods used to genetically modify patient cells while ensuring the best possible Total Viable Cell Count (TVC) to support patient treatment. This facility reduces unplanned downtime to less than one incident in 10,000 years, meeting a risk standard historically unique to the nuclear power industry. Other notable elements include an overview of the site and its achievement of becoming USGBC LEED Platinum Certified, as well as water and energy conservation initiatives at the site and across AstraZeneca. Participants will also learn how we achieved 100% uptime in a fully electrified, carbon-neutral facility.
All attendees must wear closed-toe shoes.
Photography is not permitted inside the building.
Attendees must bring identification for check-in.
Overwhelmed by 95+ Sessions? We've Got You Covered.
Skip the guesswork. We've curated three targeted agendas designed to maximize your conference ROI and deliver real Monday-morning impact, not just inspiration.
Choose your agenda based on where you are in your pharma journey:
Perfect for professionals new to pharma, career-changers, or anyone building foundational knowledge in pharmaceutical manufacturing.
Built for managers implementing technologies, leading teams, and solving complex operational challenges daily.
Designed for executives shaping enterprise-wide transformation and industry-wide innovation strategies.
Each agenda includes decision-making guidance for every time slot, so you'll know exactly why each session matters to your role and goals.
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.