Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
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In this workshop, attendees will take a deep dive into the potential impact of the European Commission's proposed PFAS ban. Additionally, the session will explore the implications of TiO₂ and EthO regulations.
The workshop will feature presentations from various companies and organizations (e.g., Takeda, Roche, EFPIA, and GSK) to provide a holistic view of the current challenges. EFPIA and ISPE have already collaborated on this topic, providing feedback to the European Commission (EC), and in 2023, ISPE launched a survey to assess companies' understanding of the potential impact of upcoming regulations.
Engaging discussions between attendees and speakers will help deepen knowledge, address concerns, and foster an open dialogue on how these product restrictions could affect the pharmaceutical industry. Are alternative solutions available? These key questions will be explored through an enhanced Q&A session designed to facilitate comprehensive discussions.
This workshop is part of Track 1: Sustainability, which addresses the multiple topics and challenges associated with this evolving field.

Technip Energies

Takeda

Eli Lilly

EFPIA

F. Hoffmann-La Roche AG

GSK
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
The workshop will address drug shortages from the perspective of Cultural Excellence. ISPE is currently revising its GAP Assessment Tool, based on the 12 domains outlined in the new Drug Shortage Prevention Model. During the workshop, attendees will gain insights into the progress of this initiative.
Additionally, ISPE is pleased to confirm the participation of the European Medicines Agency (EMA) in this workshop. Attendees can expect valuable insights into EMA's approaches to improving drug shortage prevention and communication.
Through participation, attendees will develop a deeper understanding of the GAP Assessment Tool, its value to the industry as a whole, and how it can support global drug shortage prevention
Part 1: Digital Transformation Champions:
Representatives from leading pharmaceutical companies will share their insights on digital transformation. This session will provide an overview of innovative approaches and strategies being implemented across the industry, setting the stage for a deeper exploration of digital transformation. Some additional areas to be discussed include the business drivers and capabilities, how to navigate the high costs, what are the challenges, what are problems that digital solutions can support.
Part 2: Interactive Panel Discussion with Digital Transformation Champions:
This next session will feature an engaging dialogue between our Digital Transformation Champions. The panel will delve into the challenges and opportunities of digital transformation, fostering a collaborative environment for knowledge exchange and highlighting innovative solutions that drive progress. Questions will be asked such as “Who was the sponsor of the digital transformation initiative”.
Part 3: Interactive Discussion with Audience:
This highly interactive session will focus on identifying the critical success factors for implementing digital transformation initiatives. Participants will engage in discussions on practical approaches, such as determining the most suitable program sponsors or initiators within their organizations (e.g., CIO, CDO, Digital Technologies Leader). Additionally, the session will cover strategies for achieving these goals, sharing valuable tips and lessons learned. Emphasis will be placed on achieving success and driving innovation, while navigating the challenges associated with digital transformation journeys, such as CAPEX and OPEX costs, workforce considerations, and other potential obstacles or challenges.
Join us for an insightful and dynamic workshop that promises to equip you with the knowledge and tools to navigate the evolving landscape of digital transformation and driving innovation in the pharmaceutical industry.
By comparing the predictability, duration, and damage of man-made versus natural disasters, we uncover valuable lessons in risk assessment and mitigation. From anticipating geopolitical crises to understanding the overlooked risks of natural calamities, this session highlights strategies for safeguarding operations, ensuring data integrity, and supporting staff during crises. Attendees will gain actionable insights into building resilient systems that protect patient safety and regulatory compliance in the face of unforeseen events.
This session will feature a panel discussion with presenters from Ukraine, Poland, the Czech Republic, and Spain, providing an opportunity to address questions from the audience.
When it comes to industrialization, biopharmaceutical manufacturing is somewhat different from other industries like automotive or semiconductors. Despite rigorous quality standards, there is a lot of variability in the way we operate and communicate across the entire sector. Each pipeline has its own “touch of magic.” Each company has its own “flavor” in drug recipes and manufacturing approaches, and each manufacturing site has its own installed capabilities. The differences become painfully apparent when scaling up a program, or when we transfer programs from company to company or from one location to another. In the end, those differences can create key bottlenecks when we - as a combined industry – do our best to provide medicines to our clients for their patients.
However, underneath all of the differences there is a common core from which we can industrialize biologics much more. At FUJIFILM Diosynth Biotechnologies, we are pushing industrialization of biologics to the next level, fighting those bottlenecks. Our uniform operating philosophy with modular approach, KojoX, is the framework for our aggressive expansion journey in which we build a global network of process and manufacturing capabilities operating in a uniform way with second-to-none delivery performance across sites, scales, modalities, and drug life cycle phases.
The presentation focuses on the intersection between Annex 1 and Pharma 4.0, with a specific emphasis on the innovative Takeda Linz beePFS project. It will begin with an introduction to Takeda and its Linz production site, highlighting the company's values and unique beehive culture. The overview will explain how these values influence the beePFS project, a high-speed initiative aimed at implementing a prefilled syringe filling line to reduce process performance qualification time to 24 months, while incorporating aspects of Pharma 4.0 and updated Annex 1 guidelines. The objective of the beePFS project is to enhance syringe supply security with a dual-source strategy, enabling larger quantities to be supplied quickly and adding in-house syringe filling capabilities to Takeda's aseptic network. The presentation will explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing, showcasing the transformative potential of the beePFS project as a pioneering innovation in the industry. It will address the challenges of integrating new requirements and technologies, the decision-making process for technology selection, and how Takeda leveraged the concept of Pharma 4.0 to ensure a lean, compliant production process within a fast-tracked project timeline.
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
We will cover:
- The evaluation of supplier execution tools and their impact on time, cost, consistency, and quality.
- Innovations in automated design-to-code processes and smart commissioning, highlighting efficiency gains.
- Future enhancements through AI for code validation and automated testing.
- Lessons from suppliers using customer-owned platforms, like Kneat and QALM, and the challenges of technical and workflow alignment.
- Key strategies for integrating these tools into Project Validation Strategies, including supplier engagement, role clarity, and validation workshops.
The speaker will represent the experiences of GSK and EFPIA companies in interactions with the EMA, FDA, and other regulators on the use of modeling in development, and present a vision for how best to deliver pharma 4.0. Points to cover will include:
- Real world examples and experience in justifying the use of models (using examples such as stability modeling, PBBM, design space models, and digital twins)
- A vision for the use of process models in regulatory submissions and manufacturing, including considerations for the framework supporting the use of AI and ML.
- Considerations for the evolution of EU and ICH guidance to enable the use of models
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
A Case Study, detailing how we utilized GAMP 5 Second Edition to help a leading Life Sciences Organization Implement and Validate the following Health Cloud Platform, a description of functionality and capabilities are detailed below.
- Health Cloud (HC) is a modular platform built on Technology contextualized for the Health and Life Sciences sector.
- It allows the organization to connect Hospitals, Nurses, Patient Services, and Pharmacy with our Patients through a series of Cloud Services:
- Health Cloud CRM – Manages the Patient Record and is the central view of the patient's needs: Assets, Regimens, Stock Levels, Prescriptions etc.
- Communities – Enables connection via the HCP Portal (for patient referrals and ongoing communications) and Patients (for day-to-day contact within the organization) via the Patient Portal.
- Application Field Service – Enables Field Based care through efficient high-volume route planning and patient-facing treatment management.
- All the above sits within a Life Sciences Organization that can be expanded to other business units.
- Improve Asset Utilization and Uptime
- Improve Equipment Reliability
This Proof of Value showcases how our combined solution empowers GSK to proactively address asset maintenance issues, ultimately minimizing production downtime and costs. The integrated platform using Cognite Data Fusion, Autodesk BIM model, SAP, Mendix Connectors and Artificial Intelligence, provides field engineers with asset data including Piping and Instruction Diagrams (P&ID's), instructions manuals, images, SAP work orders, etc.). This enables rapid troubleshooting, informed decision-making, and streamlined maintenance execution. The solution promotes efficiency, safety, and cost reduction for GSK's production operations.
- Throughout the duration of this project, significant insights, explorations, and opportunities have surfaced, enriching our comprehension of GSK's data sources, business processes, and the integration of cutting-edge technologies within the GSK ecosystem.
This initiative is significant as it merges proven technology from various industry segments with a specialized design tailored for cleanrooms. The Robot has established itself as a reliable autonomous mobile robot across several industries, demonstrating versatility and efficiency. In partnership with Eltronic A/S, we have enhanced this technology by incorporating design modifications to ensure compliance with industry standards required in pharmaceutical cleanrooms.
Retrofitting for Cleanroom Applications: Insights into the design modifications to meet cleanroom standards, including materials used and engineering processes involved.
Automation in Cleanroom Environments: Discussing the reduction of contamination risks, improved operational efficiency, and the flexibility offered by AMRs.
Environmental Monitoring Capabilities: Highlight how the integration of AMR can facilitate real-time environmental assessments, ensuring that cleanroom conditions meet regulatory requirements and operational standards.
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
The case study features detailed hazard screening of an RABS filling line, which uncovered critical process improvements previously overlooked, resulting in a significantly safer operation. The insights gained also facilitated the technology transfer to state-of-the-art equipment, integrating Quality by Design (QbD) and Quality Risk Management (QRM) principles. A key highlight of the study is the implementation of a fully integrated QRM approach. Utilizing AI, this approach automatically generated essential manufacturing documents - such as MBR, SOPs, training materials, and process overviews - directly from the risk profiling repository. This automation enabled shop floor personnel to manage residual risks more effectively and was supported by a comprehensive surveillance program.
As the life sciences industry evolves, the integration of AI, sequencing technologies, and digital biomarkers, coupled with strong digital quality and validation processes, is at the forefront of personalized medicine. This proposal explores how these next-generation technologies are transforming healthcare by offering patient-specific treatment plans based on a deeper understanding of disease mechanisms and drug responses, validated for accuracy and compliance.
Personalized medicine, supported by AI and digital biomarkers, requires rigorous validation to optimize drug development processes, ensuring efficacy and safety while maintaining regulatory adherence. Digital quality frameworks play a pivotal role in verifying the accuracy of AI algorithms and ensuring that digital biomarkers meet industry standards. This presentation will focus on two key aspects: the predictive capabilities of AI and the validation strategies that support their implementation in personalized medicines.
Attendees will learn how machine learning models predict adverse reactions, identify actionable biomarkers, and guide clinical decisions, with digital quality ensuring the integrity of these models. Additionally, insights into the validation of real-time data from wearable devices will be provided, showing how these processes contribute to patient-centric care.
The pharmaceutical industry faces significant challenges in fast expanding production capacity to respond to the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to respond to the dynamic demands of modern healthcare. This paper proposes a novel regulatory framework for Distributed Manufacturing that leverages the concept of "Fleet Management" to address these challenges. Fleet Management involves creating a network of standardized manufacturing facilities that can be efficiently managed and replicated across multiple sites. This approach draws inspiration from the principles of standardization that revolutionized other industries such as automotive manufacturing.
The proposed approach offers significant benefits, including improved regulatory efficiency, reduced drug shortages, and enhanced environmental sustainability. The paper calls for collaboration between regulators and industry stakeholders to refine and implement this innovative framework, paving the way for a more resilient and responsive pharmaceutical manufacturing ecosystem.
Chiesi Farmaceutici, a well-established international Company operating in the research and manufacturing of respiratory health, rare diseases, and specialty care pharmaceuticals, has recently completed its state-of-the-art biotech center of excellence in Parma, Italy, dedicated to the development and production of Mab’s, enzymes and therapeutic proteins – a significant enhancement and innovation to bring new treatments to the market. The presentation will introduce the passionating journey for the scaleup of a promising product, the challenges of the tech-transfer from a Third-party contractor, the design of the facility with the support of Wood as A&E for the realization/startup, how Chiesi has grown/trained the staff to operate the plant – ultimately showing how the plant is ready for efficient/flexible development/manufacturing of multiple products at different scales under full GMP compliance. Will be also described the unique design features introduced for the proficient/flexible operability, the challenges addressed during engineering and construction with regards to the implementation into a constrained site, and the advanced solution adopted for a more resilient and sustainable facility.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
Contents include:
1. Key digital validation concepts- such as how to achieve data integrity by design, and true copy practices with digital validation tools.
2. Creation of business cases for digital validation – by enhancing efficiency and compliance in validation processes, whilst increasing knowledge management.
3. Implementation and governance of digital validation systems - including effective implementation and validation strategies, management of change to a digital validation mindset, and avoid “paper on glass”, data-centric instead of document-centric mentality.
4. Key regulatory considerations – including recommendations for digital validation use in audits, and maintaining robust data integrity.
5. The presentation will also discuss where we are currently with digital validation systems in the industry and future advancements that will ensure a comprehensive digital ecosystem that enables validation 4.0 principles, via integration with other systems, and advanced technologies such as AI/ML.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
In today's fast-paced, resource-constrained industrial environment, the challenge of balancing innovation, operational excellence, and financial prudence is more critical than ever. The efficient management of Capital Expenditure (CAPEX) is essential to the long-term sustainability and growth of pharmaceutical manufacturing and other highly regulated industries.
This presentation will explore the critical role that Good Engineering Practices (GEP) play in ensuring that investments in physical assets - such as manufacturing equipment and facilities - are optimized through robust governance structures, clear processes, and alignment with strategic goals. The process of CAPEX management, from initial project identification to final approval and post-implementation review, will be dissected, with particular focus on:
- Governance and Stakeholder Management: Ensuring that the end-to-end CAPEX process meets the needs of key stakeholders such as project sponsors, financial controllers, and resource managers.
- Project Prioritization and Approval: Outlining the criteria for project selection, approval, and the role of Investment Committees.
- Risk Mitigation and Supporting Rational: to ensure effective prioritization, approval and implementation, optimization of return on investment
- Efficient Reporting: Utilizing digital platforms for efficient CAPEX tracking, forecasting, and reporting; maintaining regular financial updates enabling accurate forecasting, tracking, and cash flow control.
1. Alternative Refrigerants in Freeze-Drying: Examines using natural refrigerants in pharmaceutical freeze-drying, highlighting design, risks, and benefits.
2. Decarbonising Pharma with Heat Pumps: Showcase integrating heat pumps to reduce carbon emissions in pharmaceutical sites, focusing on design and efficiency.
3. Digitalisation & Sustainability: Path to Net-Zero: Explores how digital technologies enhance sustainability in the Life Sciences industry, optimising energy use and reducing waste. These topics showcase how innovative approaches and technologies are being leveraged to meet sustainability goals, reflecting the latest trends and priorities in the field.
This presentation will show you why it's so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
This dynamic panel discussion brings together leading European Medicines Agencies to explore the rapidly evolving landscape of pharmaceutical regulation in the digital age. As the industry embraces new technologies and data-driven approaches, regulators face both challenges and opportunities in ensuring patient safety, product quality, and regulatory compliance.
The panel will delve into key areas shaping the future of pharmaceutical oversight, including data management strategies, regulatory vision, future regulatory collaboration and impact of AI/ML on Pharmaceutical Regulation
Separate registration required.
The buses will be leaving and arriving at the hotel, with the expected drive time up to a 90-minute each way.
While astronomers explore the vastness of outer space, researchers at the Crick investigate the microscopic inner workings of the human body. Through groundbreaking laboratory research, the institute aims to advance the diagnosis, prevention, and treatment of diseases, shaping the future of healthcare.
This tour offers a behind-the-scenes look at world-class research facilities and the pioneering work being done to push the boundaries of biomedical science.
Separate registration required.
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.