Organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, worker experience, product quality and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information and knowledge - including their people’s implicit and tacit knowledge - to maintain a competitive advantage and meet these high demands.  This workshop is a continuation of the European Annual Meeting Workshop and will include learnings and output from attendees.  As well, comparisons from US and European attendees’ experiences will be made to benefit future ISPE content.

In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1.  Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence.

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies.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 their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization. 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. APQ includes practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can be evaluated and then improved upon.

Optimizing Cost of Goods for Cell Therapy Production--Current and Future Tools for Consideration This session will present two case study vignettes where companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset.  The case studies focus on key Guide principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization.  Specific references to the Guide will be provided as part of the interaction with the Audience.

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Check-in, un-wind and enjoy yourself at the ISPE Sunday Social! Conveniently located on-property, come join us for cocktails, hors d'oeuvres, prizes 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 2024 ISPE Annual Meeting & Expo off right!

Join ISPE to celebrate the 2024 FOYA Banquet and Awards Celebration where we will formally recognize and celebrate the 2024 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner. Please note, the In-Person All Access Pass includes the FOYA Reception and Banquet. All other registration types, MUST register separately and pay.

Join us for ISPE 15th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $50 is required to participate. Registrants must collect their bibs and t-shirts at the Information Desk onsite.

Emma Black’s inspiring journey living with a rare neurological condition called Rett Syndrome.  Mrs. Jill Black, Emma’s mother, will share six-year-old Emma’s story including the diagnosis, her day-to-day life, therapies and treatments, and what brings her hope for Emma's future. Individuals with Rett syndrome may not lead a “typical” life, but they can lead an incredible one

Integration of AI brings inherent challenges that must be understood for effective digital innovation.  The inherent challenges range from availability and governance of data to the need for agile development processes and organizational change management.  In response to such challenges, identification of strategies and best practices is essential and should include such things as data governance frameworks, promoting diversity in both training data and development teams, adopting flexible methodologies to accommodate the iterative nature of AI.  Learning to effectively implement AI involves not only technical expertise but also an organizational culture that supports experimentation and continuous improvement. This includes a cross-disciplinary approach leveraging insights from data scientists, IT, business stakeholders, and the quality organization to ensure the AI enabled technologies are aligned with objectives of the business, are ethically and responsibly integrated into operations.

This presentation is meant to provide an outline of reliability considerations for the development of combination products that can be tailored for the specific application. A core principle of developing a reliable product is that reliability engineering needs to occur at a system level. Every decision, from which technologies are used, to the number of parts, to testing strategies, needs to incorporate reliability engineers into the decision-making process. Reliability starts with the user needs, gets translated into product requirements, gets incorporated into risk management, is a critical component of design development activities, a cornerstone of testing, influences manufacturing processes, directs on-market activities, and is critical for patient benefit.  Reliability engagement at combination products begins at the product design and development through the commercialization of product lunch and its continuous improvement of patients’ feedback and field observations. Reliability is more than testing or a demonstration, but rather, it is an application of scientific principles to a set of decisions that impacts patients, product performance, and business success.

Buildings account for almost 40% of global greenhouse gas (GHG) emissions. This relates to emissions arising from materials of construction and operational emissions such as energy. The global transition to Net-zero will require decarbonization changes across all elements of society, including the way we design our buildings and manufacture products. Decarbonization strategies for manufacturing facilities, both existing and new build, are essential.To achieve Net-zero Buildings, the embodied carbon emissions associated with building construction must be understood and reduced. Reducing operational emissions alone will not achieve Net-zero. Regulatory authorities globally are now recognizing this and introducing legislation for the reporting of whole life carbon emissions associated with building construction.This presentation will provide an insight into the source of carbon in pharmaceutical buildings with case study findings on whole life carbon assessment of pharma manufacturing facilities. An overview of life cycle assessment (LCA) for carbon emissions will be provided including the challenges & design strategy opportunities for the construction of industrial buildings.

Lifecycle Management Considerations for Cell And Gene Therapy Products to Expand Access And Drive Affordability
Join us as we delve into the realm of lifecycle management considerations for cell and gene therapy products. In this enlightening presentation, the audience will learn more about regulatory strategies aimed at broadening patient access while fostering affordability in the realm of transformative medical innovations. The presentation will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.

This presentation will discuss US FDA's recent organizational changes and ongoing initiatives related to application assessment. 
In 2024, two major reorganizations occurred in FDA that significantly changed where and how drug quality oversight is conducted. First, the quality assessment offices (formerly ONDP, OLDP, OBP) and research office were reconfigured, with the intent to create a more streamlined, agile and flexible organization and to reinforce the connections between assessment, inspection, surveillance, research and policy operations. Second, the Office of Regulatory Affairs is being reorganized into the Office of Inspectional and Investigations, with the intent to reduce duplication and streamline actions, hopefully leading to more clarity and promptness in enforcement actions for regulated industry.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.

There is a lot of buzz surrounding AI and its potential to revolutionize various industries, including pharma. However, despite the hype, the adoption of AI often lags, and its actual implementations remain limited to proof-of-concepts. This presentation will bridge this gap by showcasing an in-house-built AI solution that leverages the latest advancements in NLP for deviations analysis.The presentation will walk the audience through practical aspects of building and scaling an AI solution, focusing on key points such as preparing data and training a model. It will delve into the business impact of the solution and, whenever possible, demonstrate examples where the solution adds value. Specifically, it will demo search capabilities, similarity or recurrence analysis, and automated trending. Furthermore, the presentation will address a crucial aspect of building an AI solution -- assessing solution's performance. It will discuss what a validation protocol might look like for AI solutions to ensuring their reliability and effectiveness.Lastly, the audience will be guided through steps to kickstart the adoption of AI for Quality within their organizations. By the end of the presentation, attendees will have a clear understanding of how to leverage AI to reengineer and enhance quality processes.

In today's pharmaceutical manufacturing landscape, the effective management of alarms is paramount for ensuring operational efficiency, product quality, and regulatory compliance. Eli Lilly, a global leader in pharmaceuticals, has embarked on a journey to enhance its alarm management practices using innovative technologies. Leveraging an advanced analytics platform, Eli Lilly has initiated a transformative initiative aimed at consolidating alarms and optimizing their management workflows. By implementing a centralized approach, Eli Lilly aims to achieve consistency in alarm handling, improve response times, and reduce the potential for alarm fatigue among operators. Furthermore, this initiative serves as a catalyst for global collaboration by facilitating data and knowledge sharing between sites. Through the standardization of workflows and the establishment of a centralized repository for alarm data, Eli Lilly is fostering a culture of continuous improvement and harmonization across its manufacturing network.

Supporting J&J's vision for a sustainable future is their commitment to sustainable facilities. Recognizing the importance of what we build and how we build, we started a challenging initiative last year, focusing on embodied carbon emissions for our capital construction projects. While operational carbon emissions have received significant attention, embodied carbon remains relatively unknown in the construction sector and within our Project Delivery teams (PD). Our mission was clear: to bring clarity and quantification to the concept of embodied carbon in our construction projects and look for opportunities to reduce our footprint. We asked an external consultant to provide us this quantification based on 3 pilot projects. This mission gave us interesting insights into our carbon footprint, providing us with key takeaways to integrate into our future projects. Furthermore, we worked towards generic guidelines on how to implement embodied carbon reduction strategies into our future construction projects. Our next steps involve disseminating these insights to our global Project Delivery and Engineering team, ensuring this knowledge becomes embedded in our organization. Additionally, we aim to establish a benchmark to implement sustainable practices across our entire (future) building portfolio.This way we put our corporate’s sustainability ambitions to practice in our facilities.

The development and commercialization of ATMPs present unique challenges at the intersection of regulatory compliance and CMC processes. As companies progress from clinical trials to commercial production, they encounter many regulatory hurdles and CMC complexities that demand strategic navigation for successful market entry. This presentation delves into the critical regulatory and CMC considerations for ATMPs throughout clinical development. We explore key regulatory frameworks, such as FDA and EMA guidelines, and highlight pivotal CMC factors including scalability, process validation, and supply chain management. By addressing these challenges proactively, companies can optimize their development pathways, mitigate risks, and ultimately deliver innovative ATMPs to patients in need.

Modeling plays a critical role in drug manufacturing by providing a systematic and data-driven approach to optimize and streamline various production of pharmaceuticals. Physiological models are used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body.  These models are based on the integration of physiological, pharmacological and pharmaceutical data to simulate and predict drug behavior in vivo. Recently significant progress has been made to advance Health Authority acceptance of Physiological Based Biopharmaceutical Models, PBBMs.  Using PBBMs, researchers can simulate the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug under different scenarios, including different formulations, dosing regimens, and patient populations. By leveraging PBBMs, scientists can potentially predict how changes in formulation or other factors may affect drug exposure and therapeutic outcomes. In some cases, regulatory agencies may accept well-validated PBBMs as a substitute for certain types of BA studies.  The presentation will provide an overview of the application of Physiological Based Biopharmaceutical Models including in drug development, set specifications and managing post approval change. Additionally, a summary of the significant progress in the regulatory landscape and acceptance of PBBMs.

Process validation encompasses a lifecycle approach of three stages, from Process Design or Development, (Stage 1) through a Continued/On-going Process Verification (CPV), (Stage 3). Since Stage 3 is typically a long manufacturing phase, extensive data is accumulated, trended, and analysed there. While established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP) offer a good foundation in this work- they alone fail to provide a comprehensive depiction of the entire process including its extensive historical context. Therefore, to accomplish effective CPV implementation, it is highly recommended to incorporate process automation, Process Analytical Technologies (PAT), and a profound understanding of both the manufacturing process and drug product. To enrich data evaluation in Stage 3, statistical methodologies and multivariable analysis are now complemented with the integration of artificial intelligence (AI). AI-empowered CPV not only facilitates real-time release (RTR) and the adoption of continuous manufacturing, but also heightens the power of such concepts as the Golden Batch. Leveraging AI here expands the predictive, classifying, recognizing, and recommendation capabilities essential for continual improvement of the process, ultimately contributing to elevated product quality.

As part of the company transformation, Sanofi has embraced digitization tools to complement and improve quality decisions. During this presentation, we will describe one to two use-cases/tolls recently deployed. Both tools use elements of Artificial intelligence for collecting and analyzing data.One tool is a mobile and web app that delivers real-time, reactive data dashboards, giving a 360° view across our activities. The tool brings data from across Manufacturing & Supply, Supply Chain, QA, Regulatory, Clinical Operations, R&D into one, accessible place.  And, through the power of AI, the tool uses this data to deliver actionable insights to help make informed decisions. For the presentation, we would focus on how the tool is used or Complaints.  The second tool, for monitoring of deviations, uses machine and language learning. The tool has eliminated the need for manual and time-consuming searches, and it allows to identify deviation recurrence across multiple sites. The multifunctional tool is based on a search engine, a deviation cluster browser, a root cause analysis assistant, and performance dashboards., allowing manufacturing and quality to readily identify trends and prioritize specific topics, accelerating problem solving for Manufacturing & Quality personnel.

Sustainability is a focus area in the pharmaceutical industry.  The pharmaceutical industry is a customer focused industry that puts its patients first.  A sustainable process is healthy for our environment.  A healthy environment supports a healthy patient.  AstraZeneca has a bold sustainability ambition which includes being carbon neutral by 2025.  Our presentation will display the journey of the Mt. Vernon AstraZeneca Supply Site to becoming a sustainable manufacturing facility achieving carbon neutrality by 2025.  This journey highlights a true corporate commitment, the role of technical partnerships, the importance of engaging your team across all levels, and of capitalizing on both big and small opportunities.

Over the last decade, Cell & Gene Therapy Catapult in the UK has worked with industry in the development, production and adoption of ATMPs.  CGT Catapult is an independent innovation and technology organization committed to the advancement of cell and gene therapies, with a vision for a thriving industry delivering life-changing advanced therapies to the world.  The collaboration with regulators, a total of 15 agency visits / inspections to date, has been a key contributing factor to the success of the Cell & Gene Therapy Facility.  Learn how multiple ATMP modalities have been successfully accommodated in the same facility and the steps taken to remain fully compliant.

Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

Amgen Ohio’s new state-of-the-art packaging facility achieved dramatic operational efficiencies in capacity, productivity, and environmental sustainability. But how did they get there? This presentation delves into the foresight, planning and collaboration that was necessary to achieve a truly automated and integrated next-generation facility, including the development of a Pharma 4.0™ digital roadmap and site-specific digital tool deployment whitepaper. This connected facility harnesses smart communication between packaging equipment like automated storage and retrieval systems (ASRS), automated guided vehicles (AGV), manufacturing execution systems (MES), and laboratory information management system (LIMS) with integration across mechanical systems for operationally efficient automation. From design to development, greater efficiencies were continuously sought out. Leveraging the latest project execution technologies, like advanced material movement modeling, led to reorienting equipment, conveyers, ASRS and AGV routes to optimize facility design and material flows.A key factor of this digitally enabled facility is the impact on the workforce, which provided opportunities for new roles, as well as up-skilling or re-skilling employees. Through practical insights and lessons learned, attendees will gain invaluable perspectives on optimizing the integration of new technologies to drive operational excellence.

An organization’s culture is the critical factor for success in changing environments and globalization. Cultural dynamics are the most challenging elements to manage, yet they yield the most return on investment. Implementing strategies for growth and value creation are insufficient without a cultural transformation strategy. We will outline principles and strategies to identify the benefits of a cultural transformation journey. If conceptualized, designed, and implemented correctly these benefits will vastly outweigh the investment. We will demonstrate the value creation through growth opportunities, loyalty, innovation, and the overall happiness index. We will focus on the challenges, opportunities, and untapped value that an organization can derive from initiating and designing a well-integrated approach. We will demonstrate how AstraZeneca is propelling cultural changes systematically by creating a futuristic vision and redefining their priorities. We expand on the tried-and-true tactics of breaking down silos and leveraging information technology, and introducing new concepts to aid in cultural transformation. Unlocking lateral thinking, coordinated activities, and the humanization of leaders and peers, all accelerate innovation and develop a future proof team poised to meet the company's sustainability vision and strategic goals. We will demonstrate a progressive approach to creating a holistic roadmap to drive cultural change.

Supply chain reliability is top of mind in the U.S. and globally. Supply chain breakdowns from manufacturing quality issues and other disruptive events are too frequently causing drug shortages with devastating impacts on patient care.Recently launched in 2023, the Duke-Margolis Institute's ReVAMP Drug Supply Chain Consortium is driving robust discussion on drug supply chain improvement opportunities for the US market.  The Consortium’s mission is to generate effective policy solutions that promote a reliable drug supply chain with advanced manufacturing capabilities and, ultimately, to improve patient outcomes by reducing the frequency and severity of drug shortages. Based on input from a wide range of experts involved in manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium puts forward written policy recommendations and other work products to advance these aims. The Consortium aims to build a drug supply chain that ensures patients access to safe and effective drugs, in adequate quantities, when they’re needed.

This discussion is adapted from the 2024 ISPE Allogeneic Cell Therapy Guide, which focuses on manufacturing facility development and design for allogeneic cell therapies. The development, regulatory path, facility design, qualification, and manufacture of ATMPs present significant challenges to manufacturers, engineers, and suppliers. The GMP regulations are evolving as novel processes are presented and manufacturing paradigms are being tested. This discussion addresses facility engineering issues that are most applicable in facility design today, as allogeneic cell therapy manufacturing processes – and ATMPs in general – continue to rapidly evolve.The first section will discuss contamination control strategies and multi-product processing.The second section will discuss the allogeneic cell therapy manufacturing process.The third section will discuss allogeneic cell therapy facilities, key design elements, and common challenges.

Artificial intelligence (AI) has disrupted almost every sector, including that of healthcare. As of December 2023, the FDA has cleared more than 520 artificial intelligence (AI) medical algorithms since 1995, with 171 AI-enabled medical devices added to the list in 2023. However, international harmonization on AI is far from achievable currently.
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.

Our presentation will showcase a real-life example of how Gilead’s Research and Engineering teams work together to bring Innovation and Pharma 4.0 into the lab.  Our proposed session will build on the 2023 Vegas ISPE keynote fireside chat between Gilead’s Head of Research, Flavius Martin, and our SVP of Corporate Operations, Joydeep Ganguly.  In the keynote last year, they discussed the role engineering plays as a catalyst to Gilead’s science.  As we are the ‘boots on the ground’ execution team, we would like to circle back to this keynote and share some returns realized in how we’ve collectively built both an innovation framework, and to showcase a brand-new Pharma 4.0 lab that was built as a direct result.  Our presentation would include Strategizing Bringing Pharma 4.0 to Life in the Lab, Engineering and Constructing the Pharma 4.0 Lab, and Maintaining and Systematizing our Successes. We would like to finish our session by sharing our new co-designed Research Robotics lab.

With the ultimate goal of delivering therapeutic treatments to patients at the lowest possible cost, manufacturing facility planning efforts understandably focus on efficient flows, optimal adjacencies, and streamlined infrastructure, while also considering options for future expansion, but what about the people actually performing the work? Too often, human-centric concerns are overshadowed by the need for process improvements and operational efficiencies.With an ever-increasing competitive landscape, attracting and retaining skilled staff has become a critical challenge.Our research has uncovered key criteria that shape pharmaceutical facility architecture, establishing crucial characteristics that ensure the well-being and overall health of the people tasked with delivering these lifesaving therapies, while enhancing an organization’s ability to attract and retain the best talent.This presentation will demonstrate how an integrated design and planning approach, coupled with the clear vision and mission of an organization, can create efficient and sustainable manufacturing environments, while also supporting the effectiveness, health, and well-being of the staff working within them.This presentation will also address technologies and innovative processes that enable organizations to measure the efficacy of these design strategies.A 3rd speaker has been confirmed for this session: Elizabeth Strutz, Associate AIA, MSIE, PMP, Director of Process Innovation, Flad Architects

The regulatory landscape related to drug shortage prevention has changed over the last several years due to large-scale, highly visible events (e.g., COVID-19 pandemic, geopolitical issues, hurricanes, etc.). Rapidly evolving drug shortage requirements followed and has generated nuanced differences across multiple markets in definitions/ approaches, reporting expectations, and risk management planning. As a result, ISPE formed a Global Convergence Opportunities team with its Drug Shortages Initiative to assess trends in drug shortage-related requirements and identify opportunities to harmonize definitions and approaches across markets. This presentation will discuss the findings and correlating recommendations being made in the interest of bolstering supply chain resiliency.

With the number of cell and ex-vivo gene therapy products entering the clinic growing exponentially, we must, as an industry, look ahead and plan accordingly so that we can deliver these revolutionary medicines to large patient populations safely and efficiently. Regardless of the specific modality – and the autologous or allogeneic format – cell therapy processes are not standardized and present significant challenges to facility designs intended to support transitions towards process closure and scale-up, multiple products and/or multiple clients. This presentation will share lessons learned from recent flexible cell therapy facility design projects that enable organizations to meet the needs of evolving cell and ex-vivo gene therapy manufacturing processes.

In response to the need for faster regulatory timelines and growing patient demand, this session proposes a technological shift in CMC submissions through structured content and generative AI (GenAI). We aim to transition from manual, siloed processes to a seamless, technology-driven approach, enhancing efficiency and data integration. The presentation will: 1) Demonstrate the synergy between structured content and GenAI throughout the authoring process; 2) Highlight the advantages of a structured, standardized, interoperable ecosystem, addressing adoption barriers; and 3) Provide real-world examples showing the impact of this integration on regulatory submissions.By embracing technological advancement, the biopharmaceutical industry can achieve significant strides in reducing submission timelines and accelerating the delivery of therapeutics. We aim to provide a comprehensive overview that not only showcases the potential of AI and structured content in regulatory affairs but also inspires a shift towards more dynamic and technology-driven processes by providing real-world examples that can be implemented today. However, it is essential to bring industry and regulators together to collaboratively build towards a future vision. As such, this proposal would benefit from additional speakers building similar authoring technologies, and more so, from regulators who can speak to considerations and expectations from the health authority perspective.

Now that the Pharma 4.0 Baseline guide is published, this presentation will show how to execute a Validation 4.0 approach. We will start with showing how to apply things we should already be doing, like risk management and then will dive into a real and practical example on how effective risk management can unlock Validation 4.0. This approach is expected to enable a scalable and therefore sustainable approach to achieve validation in today’s rapidly changing environment.We will have an interactive discussion on how a cutting-edge approach to validation can dramatically reduce the time and cost of maintaining compliance but also focus on decreasing risk and ultimately increasing quality.  By combining technology, structured risk assessment, and mature process controls, attendees will learn how to position their validation approach to speed the deployment of enterprise systems, new products, and even AI. We will dive into a case study to exemplify this approach and the benefits gained.

Leaders across pharma and biotechnology are facing unprecedented changes driven by technology innovation, post-pandemic workforce dynamics expectations, as well as an evolving compliance landscape. They are also challenged with high utilization from multi-product facilities requiring minimized downtime and quick turnaround.  Transforming the way to work where agility, smart risk-taking and collaboration is key to business success. Our presentation will share a case-study of how one technical leader (Head of Engineering, Facilities & EHS) at Boehringer-Ingelheim developed a strategy, operating mechanisms and culture that is able to leverage that pace of change to fuel innovation, partnerships, and results. We will share the presenting challenges, the methodology employed, and the results experienced.

How do differences in global requirements and filing timelines lead to drug shortages?
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply.  These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.Please note that this speaker is not a regulator, but it would be good to have a regulator speak in a session with this talk bundled with one or more of the Drug Shortage sessions. US FDA Drug Shortage Staff (E. Thakur or team) are suggested.

AstraZeneca is redefining industry norms and setting a benchmark for sustainable practices on a global scale. A holistic look at AstraZeneca’s global sustainability policy and approach that integrates environmental responsibility, patient-centricity, and operational excellence in cell therapy manufacturing.  In this presentation, we will highlight a case study – AstraZeneca’s new cell therapy manufacturing facility in Maryland, which serves as a prime example of the company's sustainability efforts in action. The facility design incorporates an array of features into the design, including 100% electrification, designed for LEED Platinum certification, water reclaim, waste handling, and innovative energy-efficient technologies. The presenters will demonstrate site-specific examples on how to minimize environmental impact while maximizing operational efficiency in cell therapy manufacturing. Lastly, the presentation will explore how sustainability initiatives connect to the resiliency and continuity of supply chain. The discussion will encompass various aspects, including facility design choices, operational readiness, and the company's overarching commitment to patient care. The presenters will elaborate on the strategies implemented for this project, emphasizing this facility’s role in maintaining cell therapy supply chain integrity.

As a service industry head, I have the opportunity to work with various different companies and large pharmaceuticals on their digital transformation programs. We are noticing a very high trend of AI/ML implementation on R&D as well as in Manufacturing arena. The regulations does not clear explain the needs to remain compliance when implementing ML models in GMP but various companies and quality assurance departments approaches based on their understanding. This proposal will combine the best of best practices implemented at various companies and examines the regulatory considerations when implementing AI/ML in Good Manufacturing Practices (GMP) arena. The session will also cover certain use cases implemented in the industry.

Join us for an insightful session where three industry leaders will introduce us to the world of digital tools in pharmaceuticals. Explore the deployment of digital validation tools, automated testing and monitoring tools, and innovative VR training tools shaping the future of the industry.

The presentation will showcase the recently-completed facility of Teva Biotech in Ulm (Germany) intended for large-scale manufacturing of biopharmaceutical products; it implements the most up-to-date and technology in this field, providing extensive multi-product capacity for Teva. Will be presented the features of such state-of-the-art plant of outstanding dimensions and complexity, the unique choices to maximize flexibility to future-proof the capacity to manufacturing product presently under discovery/development. The presenters will also introduce the technical and project execution challenges addressed by Teva and its Partner (Wood) during design, construction and qualification according to the latest GMP, under adherence to good engineering procedures, realizing the plant under full safe conditions.

We aim to delve into the critical connection between high-level sustainability goals, such as Net-Zero Climate, and the necessity for data transparency in product manufacturing. By examining the role of data transparency within the supply chain (scope 3) and the manufacturing facility (scope 1 and 2), this presentation will shed light on how data can drive sustainable practices through informed decision-making, process optimization, collaboration with suppliers, and resource usage optimization. The presentation will discuss how product design influences site operations and energy/waste reduction. Additionally, it will explore how sites utilizing renewable energy and innovative manufacturing equipment and techniques can further minimize product footprints. The shift towards data-driven product-level emission calculations for Scope 3 reporting will be examined, along with how manufacturing sites can provide this data using Bill of Materials (BOMs), metering, and allocation. A case study will be presented to showcase these concepts in action, providing practical examples of how data transparency drives sustainable practices and contributes to the achievement of high-level sustainability goals.

Per Alliance for Regenerative Medicine, there are almost 2000 ongoing clinical trials with an ATMP therapeutic focus as of Q4 2023.   The industry often speaks about using risk based approaches to ensure that ATMP products are produced ensuring patient safety, product quality while enabling speed to market.  There is a lack of guidance for the framework of risk-based validation in autologous and allogeneic ATMPs. This lack of guidance is leading to a slowdown in clinical trial approaches and commercialization of these novel therapies. This presentation will cover the phase appropriate and risk based approaches specific to process, analytical, cleaning, and supply chain validation strategies that are unique to ATMPs. This presentation will give a preview and provide some examples from an ISPE ATMP Guide covering this topic that is expected to be issued either before or shortly after Oct 2024.

The pharmaceutical and biopharmaceutical industries have struggled to implement effective quality risk management (QRM) programs and risk assessment strategies since the inception of ICH Q9 in 2009. In ICH Q9’s infancy, industry began performing risk assessments, lots of risk assessments without a holistic strategy or thought to an organization’s overarching risk assessment portfolio.  A historic lack of emphasis on QRM planning is a plausible reason why the industry has struggled with the administration of the QRM program and the creation of myriad risk assessments with no holistic vision.  The lack of strategic planning could also contribute to a siloed approach to QRM application and risk assessment performance.  By outlining overarching objectives for the QRM program, the use of a Quality Risk Management Master Plan can enable the pharmaceutical and biopharmaceutical industries to spend less time “doing QRM” and more time managing risk to the patient.  This plan would be a living document over time to demonstrate the current state of the program, as well as updating the future of QRM implementation.

Engage in a dynamic panel discussion moderated by industry experts as we delve into the wider applications of digital tools in pharmaceuticals. Explore the challenges, regulatory requirements, and industry perspectives surrounding digital validation tools, automated testing and monitoring tools, and innovative VR training tools. Gain valuable insights from established leaders in the field during this interactive session.

The oligonucleotide modality has seen a significant uptick in commercial approvals in the last five to seven years.  As commercial capacity has come online and future capacity is being planned to support anticipated indications that will plausibly include larger production capabilities, the broader industry is examining best practices for facility design.  Paul, Francis and Jim are part of the group that has come together to author a new baseline guide for industry for oligonucleotide facilities.  We will present the approach taken, including scope boundaries with other emerging therapeutic modalities, timeline for the guide to be published, and sample content section previews.

Given the lag time between an investment decision and having a sterile injectable facility ready to produce commercial product, having a robust manufacturing and supply chain strategy is critical to the success of sterile injectable manufacturers. In recent years, there have been many direct and indirect shocks to sterile injectable supply chains including COVID disruptions, the rise and fall of COVID vaccine demand, the explosion of GLP-1's, the signing of the Inflation Reduction Act, and a spike in interest rates. These events and trends have required sterile injectable manufacturers and CDMOs to reevaluate their manufacturing investment and supply chain strategies to efficiently allocate capital while building resiliency. This presentation is intended deep dive into the impact of these recent trends and hypothesize the future of sterile injectable manufacturing investment and supply chain strategies.

CDMOs have taken over the pharmaceutical field especially when it comes to development of novel therapies such as cell therapies, gene therapies, and RNA products which are critical to the patient population facing rare diseases. Advanced Medicine Partners has shifted the paradigm that CDMOs should work independently from clients and has taken the approach to partner with clients in various phases of development, including providing an extended workbench as a novel offering. ATMPs can leverage AMP’s wide range of analytical, process optimization and development, and GMP manufacturing capabilities to accelerate successful drug candidates getting to patients.This presentation proposes to delve into the relationship of client-partnerships, CQV deliverables, and project management tools that impact the flexibility and speed of a CDMO. Implementation of efficient site procedures with project controls over CQV deliverables can facilitate seamless tech transfers. The presentation will go over how to build a robust CQV plan, which plays an important role in the life cycle as it demonstrates product integrity and regulatory compliance. The presentation will demonstrate how using proper CQV & project management tools to manage resources, timelines, and deliverables helps not only to deliver quality products faster-to-market but can help control costs and optimize spending.

Gretchen Smith is a highly accomplished manufacturing executive with an impressive track record spanning over 25 years in the pharmaceutical industry. Currently serving as the Senior Vice President of Manufacturing and Site Head at Advanced Medicine Partners, she plays a pivotal role in leading the establishment of a cutting-edge Contract Development and Manufacturing Organization (CDMO) facility. This state-of-the-art facility is dedicated to providing unparalleled chemistry, manufacturing, and controls (CMC) capabilities for advanced medicines, including gene and cell therapies. Gretchen's expertise allows her to address the critical challenges of product quality and scalability that are often encountered in the development and production of highly technical medicines.

This presentation will offer a novel perspective on interpreting compliance data by charting significant trends in legal citations within the public domain. We will dissect how these patterns can influence corporate compliance strategies and operational frameworks. By integrating data analytics with legal insights, the session aims to provide attendees with actionable knowledge to navigate the complex regulatory environment effectively. Emphasis will be on practical applications, enhancing attendees’ ability to forecast regulatory shifts and implement preemptive compliance measures. This forward-thinking approach is essential for professionals aiming to maintain robust regulatory adherence amidst an evolving legal landscape. Overall, an open forum and additional facets can be added to the presetation to best add dubstance beyond pure data analysis.

This session will spotlight data analytics and other quality tools. Join our esteemed panelists as they delve into making informed GxP decisions based on insights gleaned from existing digital tools. Don't miss this opportunity to gain valuable knowledge and insights from industry leaders.

Industry trade groups have been discussing the merits of ballrooms and connectivity for some time. But many biopharmaceutical companies are quite conservative and assume there is too much regulatory risk in designing a facility as an open ballroom with closed processing as the foundation, especially when executing multiple product manufacturing simultaneously within the same space.This presentation will follow a case study on Wheeler Bio. A company that is challenging industry norms by embracing a novel facility design, merging a single fully open ballroom concept with process closure, backed by comprehensive risk assessments and data.The presenters will highlight how they integrated the risk analysis outcomes into commissioning, qualification strategies, standard procedures, and batch records. We will discuss the Process Closure Analysis (PCA) and its role in identifying and mitigating contamination and mix-up risks during simultaneous product runs and how various process risk assessments (pFMEAs) scrutinized and mitigated operational risks. By balancing risk with right-sized processes, Wheeler Bio’s new hyper-flexible GMP manufacturing facility accelerates the development of new therapies for patients while lowering costs to clients.

Sustainability is a term that is currently in the spotlight almost everywhere in the world. Thereby sustainability does not have to mean doing without but should be seen from the perspective of saving. Because if resources can be saved, money can also be saved. As a rule: It doesn't have to be expensive technologies such as nuclear fusion research or battery storage. There are also much simpler ways. The pharmaceutical world in particular requires a lot of energy and resources. Reducing these is not rocket science if you follow a few basic rules and focus on the right type of energy. Where is the most energy needed? What is the best technology for heating a medium? Can energy be recovered? A great deal can be achieved with a simple approach. What do you think takes more energy: Heating 1 gallon of water by 50°F or the same amount of stainless steel by the same temperature?

The gene therapy industry has witnessed comparability issues manifest throughout the clinical trial phases. While these issues were not attributed to process changes per se, they highlight the lack of thorough process understanding and process robustness when manufacturing novel products. AAV vectors are not considered “well characterized” products. This creates a challenging landscape for demonstrating comparability - and with rapidly evolving technology and manufacturing platforms, there is a need to drive systematic approaches to equipment selection and evaluation. The ISPE ATMP CoP has recently published a guide on rAAV Comparability to bridge this gap. This session will present a case study on demonstrating rAAV product comparability when changing the production bioreactor configuration and scaling up.

In 2024, two major reorganizations occurred in FDA that significantly changed where and how drug quality oversight is conducted. First, the quality assessment offices (formerly ONDP, OLDP, OBP) and research office were reconfigured, with the intent to create a more streamlined, agile and flexible organization and to reinforce the connections between assessment, inspection, surveillance, research and policy operations. Second, the Office of Regulatory Affairs is being reorganized into the Office of Inspectional and Investigations, with the intent to reduce duplication and streamline actions, hopefully leading to more clarity and promptness in enforcement actions for regulated industry.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.

M.A.P.S! was founded by a female business owner, mom, ISPE Member, and Black Belt in Martial Arts, Bridget Collins. Her program, M.A.P.S. – stands for Mindset, Awareness, Preparation, Strike! –offers empowering and educational seminars to teach and train women the basics of self-defense, helping them build a mindset and awareness around personal safety that prepares them to avoid personal attacks and defend themselves when necessary. Throughout this early morning session, you will enjoy a demonstration of martial arts techniques, practice of maneuvers to release and defend the most common forms of attacks.  This event is open to all conference attendees; we recommend you wear comfortable workout clothes as this will include a workout component for those who participate. A completed waiver will be required to attend the class; this will be available to fill out prior to starting the session.

(E)merging Tech & Talent: Spark’s Innovation & Investment in Philly

Due to the increasing digitalization of the industry, we are highly dependent on IT systems and data. Cybersecurity attacks have been on the rise for many years, with ransomware and phishing being the biggest threats to our industry. Unfortunately, people tend to assume that disasters "only happen to other people" and therefore do not pay enough attention to disaster recovery and business continuity planning. When a ransomware attack hits an organization, the value of pre-planning and preparation becomes clear and allows for efficient recovery. The presentation examines a hypothetical case of a successful ransomware attack and outlines the recovery activities required and the issues that arise from inadequate disaster recovery planning.  It also examines the potential challenges for the quality organization, such as root cause analysis and documentation of recovery activities, risk management and assessment of data integrity during recovery activities or the evaluation of short-term workarounds.

In recent years, AI/ML has sparked growing interest in pharmaceutical science and manufacturing. In this talk, we will share an overview of our journey integrating digital transformation, advanced data analytics, and operational excellence, focusing on AI/ML which we strategically pioneered and delivered significant business values in Pharma Technical Operations. We will dive into a few AI/ML use cases, including predictive & adaptive manufacturing process controls, scheduling optimization, GenAI and more. We will share the lessons learned, discuss the challenges and opportunities of applying AI/ML in the evolving yet regulated Pharma industry, and continue scaling AI/ML to enable more efficient and reliable manufacturing and supply of our critical medicines for the patients.

There is a new European directive EUR-Lex - 32022L2464 - EN - EUR-Lex (europa.eu). In 2025, large companies will have to report, in a more stringent way than 2023, on their data and actions of 2024 for sustainability. In 2026, all European companies with more than 250 employees will have to report on the data and actions of sustainability from the operations during 2025. This is a more stringent and more complex reporting, than any previous year. According to the directive, reporting will have to be approved by external statutory auditors, as per financial reports and report all actions for sustainability.

The breadth of Daniel's perspective in the Cell and Gene Therapy space encompasses early research laboratories purchasing Lonza's media, tool & technologies as well as large biotechs and big pharma, outsourcing commercial manufacturing to Lonza. During this address, Daniel will reflect on where the field stands and on the sequence of development and CMC innovations necessary for cell and gene therapies to become truly mainstream and adopted as the standard of care for a wide range of indications and large patient populations. Further to this, Daniel will reflect on the potential futures of cell and gene therapies, depending on a range of potential scenarios.

As part of the abbreviated new drug application (ANDA) evaluation, FDA recommends applicants fully understand the potential for changes in or to the active ingredient during the manufacturing process. Complex APIs are often mixtures of different components and can contain a distribution of molecular weight.  Due to their complexity in both composition and structure, complex APIs cannot be characterized by typical analytical techniques.  To demonstrate the sameness of a complex API in a generic drug product, a “totality-of-the-evidence” approach is generally employed during regulatory assessment.  This approach includes three key components: manufacturing process understanding, orthogonal characterization, and comparative biological activity analysis, if necessary.  Unlike well-defined small molecule APIs, manufacturing processes are especially critical in ensuring the consistency of composition and properties for complex APIs.  This presentation will provide an overview of key regulatory considerations on demonstrating complex API sameness.  We will focus on unique aspects of complex API manufacturing processes and facility inspection data, including data obtained through remote regulatory assessments (RRAs).  Additionally, we will present regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs.

I intend to introduce an ongoing initiative at my workplace that focuses on enhancing efficiency and resilience in the Periodic System Monitoring Process for GxP Systems. This initiative involves automating the data gathering from various sources, and assessments associated with Infrastructure System Periodic Assessments using Microsoft SCORCH (System Center - Orchestrator) and PowerAutomate. The anticipated outcome is a reduction of over 2500 documents generated annually, resulting in significant time savings amounting to thousands of man-hours.By automating the data collection, we aim to facilitate trending analysis and hopefully predictive modeling. This approach not only minimizes human errors but also enhances the timeliness of monitoring and alerts. Overall, these improvements are expected to make the process more robust, efficient, reliable, and easily scalable.

The implementation model for Eli Lilly and Company’s policy mandating automated data capture for all GMP output data involves assignment of a data integrity (DI) classification to control strategy data, alignment of instruments generating that data to the DI classification, assessment of the instrument to the requirements (stratified by DI classification) for automated data capture (based on mitigation of specific vulnerabilities like falsification and pre-testing) and remediation of identified gaps.Our team encountered and devised strategies to combat numerous challenges to implementation.  Lack of DI classification for supporting systems, like sterilization and calibration standards, led to speculation and scope creep.  The scenario-based vulnerabilities were difficult to grasp.  Moreover, the individual instrument assessments to the vulnerabilities are resource-intensive, often requiring a time-consuming, detailed review from a cross-functional team of subject matter experts.  Finally, the burden of change could be very high for existing installations with less computerized infrastructure.This model was most successful in helping new processes/installations design data integrity controls into their systems.  In addition, subject matter experts who participated in the assessments became skilled at identifying potential DI vulnerabilities and creating logic and design solutions to mitigate them, thus transferring the improvements to the next project.

The global COVID-19 pandemic exposed weaknesses in a supply chain that relies heavily on just-in-time manufacturing for personal protective equipment (PPE), medical equipment, and pharmaceuticals. Critical components involved in every step of development and distribution of medical countermeasures (MCMs), from raw materials to intermediate steps to tools that facilitate product delivery, experienced bottle necks during the pandemic.  The world competed for the same supplies to meet the demands brought on by surging cases and exposed major vulnerabilities to foreign sourced products. This was keenly felt with critical medicines required to treat the most vulnerable patients.  This dependency on foreign suppliers and developers resulted in high drug prices and, in many cases, shortages.  This discussion will offer lessons learned from the pandemic, the current state of the domestic medical supply chain and measures IBMSC is taking to ensure our medical supply chain is robust and prepared to tackle any future medical domestic supply chain events with full confidence. This session will examine the USG posture pre- and during the COVID-19 pandemic, explore the lessons learned from the pandemic, the technological advances that have been made since the start of the pandemic, and examine the future of the medical supply chain.

Decentralized Pharma: Pioneering Patient-Centric Manufacturing

Background: Germfree, an innovator in biosafety and containment technologies, has been at the forefront of deploying more than 100 mobile cleanrooms in seven years. Challenge: Healthcare faces ongoing challenges in patient access, drug shortages, manufacturing inefficiencies, and the need for rapid response to patient needs. Traditional centralized manufacturing models often struggle to adapt quickly to these demands, creating a pressing need for innovative solutions.Solution: Germfree responded to this challenge by developing and deploying advanced mobile cleanroom technologies. These units are designed to be flexible, scalable, and capable of meeting the stringent requirements for aseptic processing and manufacturing of cell and gene therapies, as well as other pharmaceutical products.Implementation: The case study will detail the deployment process of these mobile cleanrooms, including site selection, logistics, setup, and integration into existing healthcare and pharmaceutical frameworks. Lessons Learned:Future Outlook: Looking ahead, Germfree's work signals a shift in pharmaceutical manufacturing, highlighting the potential for decentralized models to make healthcare more accessible, efficient, and patient-centered. The case study will conclude with predictions for the industry and the role of mobile cleanroom technology in shaping the future of pharmaceuticals.

In a concerted effort to collect data, industry experts have put together a study that presents and analyses changes in global in-country testing (i.e., registration and import testing) requirements of the recent years. In addition, the implications of in-country testing and the industry position are presented.The review identified about 40 changes in testing requirements in more than 25 countries across the globe. The predominant trend derived from the analysis is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system. A second trend is the replacement of routine in-country testing by post-marketing surveillance testing.The results show that countries increasingly acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Furthermore it shows, that more countries extend the unilateral reliance approach to testing to further reduce duplications and associated delays in patient access to medicines.Testing waivers can help to make progress in two important concerns: substandard and falsified products as well as supply interruptions. Patients around the world would benefit from accelerated access to safe products manufactured in facilities inspected for GMP/GDP compliance by mature NRAs, which is a clearly demonstrated benefit of reliance, including for testing.

The recently published EMA guideline on computerised 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 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 presentation aims to showcase the cutting-edge concepts of Federated Digital Twins and Artificial Intelligence. Federated Digital Twins are a network of digital twins that share data, insights, and learning. These advanced frameworks and AI are essential for harnessing the full spectrum of benefits in the biopharmaceutical manufacturing.The presentation will explore how the interconnection of multiple digital twins, can create a comprehensive and holistic virtual representation of biopharma operations and their Critical Business Parameters. This Digital Twins ecosystem allows for more nuanced insights and a deeper understanding of complex systems, enhancing predictive analytics and operational efficiency across multiple facilities and processes.This approach enables unprecedented scalability and agility in decision-making, optimizing the entire lifecycle of biopharma manufacturing from design to decommissioning.Incorporating AI, the presentation will highlight its indispensable role in supporting advanced analytics and streamlining the creation and operation of digital twins. AI agents are pivotal in simplifying complex processes, automating data analysis, and facilitating the rapid realization of digital twins.This comprehensive presentation offers a forward-looking perspective on the synergistic integration of digital twins and AI in biopharma manufacturing, showcasing how these technologies can be leveraged to drive innovation, efficiency, and excellence in the industry.

Pharmaceutical manufacturing employs a variety of production processes that generate off-gas containing potentially odorous molecules. Controlling these compounds is crucial for protecting a community from unpleasant odors and health risks, and pharmaceutical makers employ a variety of technologies to treat such potential odor sources. As pharmaceutical production facilities seek to establish more rigorous standards for emission control, optimal control systems must mitigate odors in even the most challenging conditions, remain resilient to potential failure modes, and align with each facility’s budget and operational constraints. Comprehensive modeling and system design processes are critical to thoroughly consider when implementing or upgrading off-gas control systems at pharmaceutical production plants. The ideal mix of emission control technologies is a balancing act of cost and capabilities that must be carefully aligned to the unique requirements of each manufacturing facility.

In this presentation we explore a visionary approach to aseptic fill and finish processes. With operational flexibility based on technical solutions, we provide an answer to challenges deriving from diversified product portfolios and changing pipelines. The approach is applying highly standardized robotic isolator cells addressing the growing demands for highest quality as well as contamination and cross contamination control. In the matrix framework all modules are combined into a versatile functional unit to deliver efficiency, flexibility and reliability at a new level.The concept is applied as a suggested production layout that will highlight the matrix approach benefits in comparison to a conventional layout. This layout is designed to efficiently handle diverse requirements, from fill and finish of very small batch applications like personalized ATMPs to mid-scale production of conventional biologics (e.g. 25.000 units/batch).

This presentation will discuss US FDA's recent organizational changes and ongoing initiatives related to quality surveillance.
  In 2024, two major reorganizations occurred in FDA that significantly changed where and how drug quality oversight is conducted. First, the quality assessment offices (formerly ONDP, OLDP, OBP) and research office were reconfigured, with the intent to create a more streamlined, agile and flexible organization and to reinforce the connections between assessment, inspection, surveillance, research and policy operations. Second, the Office of Regulatory Affairs is being reorganized into the Office of Inspectional and Investigations, with the intent to reduce duplication and streamline actions, hopefully leading to more clarity and promptness in enforcement actions for regulated industry.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality surveillance include Quality Metrics and Quality Management Maturity.

1530-1600: Responsible Use of AI in a Regulated Environment by Michael Schmeiszer and Nade Shafiei
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success

The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.

Join us for an engaging discussion into the critical facets of 503B compounding at this year's ISPE Annual Conference through a panel comprised of industry experts. This session begins with a comprehensive overview of the ISPE Guide related to 503B compounding, setting the stage with foundational knowledge and industry standards. The following presentation will address the practical aspects of implementing a deviation and investigation program, providing attendees with actionable insights on managing compliance effectively. Concluding the panel, we will hear from industry experts on the regulatory perspectives that shape 503B compounding practices. This series is essential for professionals involved in all levels of pharmaceutical compounding, regulatory compliance, and quality assurance, offering a platform for in-depth discussion and expert guidance. Engage with our speakers in a dynamic Q&A session to further enhance your understanding and application of these crucial topics.

There is growing importance of flexibility and sustainability in the pharmaceutical manufacturing industry.  This session will discuss the challenges and solutions for supporting a highly flexible supply chain in a varying drug product environment, explore the boundaries of flexible facility design, highlight the key principles for agile/flexible facilities, showcase the successful integration of environmental sustainability into capital project delivery process, and recognize the results of being green from the start.  These topics demonstrate the importance of planning, innovation, and adaptability in achieving sustainability and flexibility in the pharmaceutical industry.

In the rapidly evolving field of cell and gene therapy manufacturing, companies are grappling with significant cost pressures as they strive to bring groundbreaking therapies to market. A critical factor influencing these costs is the selection of manufacturing technologies, which directly impacts facility design requirements, including the size and specification of cleanroom environments. Automation is recognized as a tool to enable a combination of scalability, reduced manufacturing costs and increased quality.  This panel aims to discuss the technical, quality, and regulatory considerations associated with expanding access of these therapies.

Global Adoption Status and Implementation Strategies for Q2(R2)/Q14and Q12  

The guidelines ICH Q12 (2019) and ICH Q2(R2)/Q14 (2023) embody a science- and risk-based approach to lifecycle management to ensure the continued quality of the quality of drug substances and drug products.  ICH Q12 describes the tools that can be utilized for effective post approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focus on development, validation, and lifecycle of analytical procedures; and covers concepts such as the Analytical Target Profile (ATP) and the applicability of enhanced knowledge to manage Q12 concepts such as Established Conditions.  There are many expected benefits which include harmonizing scientific approaches and terminology, enabling effective knowledge and risk management to facilitate continual improvement, and improving communication between health authorities and industry.  This session will talk about real-life examples from industry and the challenges encountered when implementing these guidelines both from the sponsor and regulator perspectives.  Topics presented from industry (the ISPE PQLI ICH Q2(R2)/Q14 and Q12 teams) will include platform analytical procedures, enhanced approaches to development practices, change management utilizing the principles of ICH Q12 and Q2(R2)/Q14 and how ECs can work, and the status of guideline adoption across various companies and health authorities.  These presentations from four major companies will be followed by an extended panel discussion including regulators to provide a format for a candid exchange of experiences and ideas to address the perceived challenges. 

Included with the In-Person All Access Pass, the add-on fee for the Tuesday Night Celebration is $225.

Immerse yourself in an evening of unparalleled networking, delicious food, refreshing drinks, and engaging activities at The House of Blues, where the essence of classic Florida comes alive. 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've taken care of transportation logistics with round-trip buses provided, ensuring you can focus on enjoying every moment of this vibrant event.

Prepare to experience the best of what the pharmaceutical industry has to offer – this is an evening you won't want to miss!

ISPE Regulatory Groups: Driving Harmonization and Quality to Benefit Patients

Join us as the ISPE Regulatory Steering Committee (RSC) provides an update on ISPE’s current regulatory activities and initiatives. Gain valuable insights into the groups that are bringing visibility and solutions to challenges faced by the industry with regard to regulatory/quality aspects and facilitating the flow of information between ISPE members and global Health Authorities. Don't miss this opportunity to stay informed and engaged in the latest developments within ISPE's regulatory landscape.

In this engaging session, Ms. Cooke will share insights and perspectives on crucial topics shaping the pharmaceutical industry, including EU regulatory initiatives, ICMRA collaborations, and outcomes from the EU-US MRA.
Explore the integration of innovation into pharma operations, updates on Pharma Legislation for 2025, and the transformative potential of AI/ML in Pharma Operations. Gain valuable insights into the EU harmonized approach to Drug shortages, including outcomes from HERA and related activities from EMA, as well as international collaboration efforts between EMA/FDA and EMA/Industry.

A Regulatory Town Hall Meeting focused on the challenges and opportunities to expand innovation, improve product quality assurance and patient access to medicines relies on global regulatory harmonization and collaborative approaches in establishing effective policies.  This paradigm shift is predicated on transformation that only a future-looking workforce can deliver.

The pharmaceutical industry is advancing through an unprecedented innovative transformation, driven by the development of new product modalities, the emergence of innovative technologies, the evolution of alternative and adaptive regulatory frameworks, and the expeditious approaches introduced and leveraged in response to the COVID-19 pandemic experience. 

The Regulatory Town Hall will cultivate a compelling discussion among several panelists on the merits, opportunities and challenges associated with the introduction of innovative technologies, the use of modelling, artificial intelligence, and digital platforms that are shaping the future of pharmaceutical development and commercialization.  The key messages from this event will provide a template for the attributes and qualities necessary to enlist and engage a skilled and competent workforce capable of adapting to  the fluid demands and expectations of patients and health care providers globally.

The panel will include six representatives from industry and regulatory authorities who will address the following evolving topics:

1. Mutual reliance: How can the industry and regulators leverage the existing frameworks and initiatives, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Mutual Recognition Agreement (MRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to enhance the mutual recognition and reliance of inspections, assessments, and standards across different jurisdictions?
2. Information sharing: How can the industry and regulators enhance the information sharing and communication between and among themselves, as well as with other stakeholders, such as patients, health care professionals, and the public, using the available and emerging digital platforms and tools?
3. Modelling: How can the industry and regulators increase the global acceptability and use of modelling and simulation techniques, such as mechanistic models, physiologically based pharmacokinetic (PBPK) models to support the design, development, and evaluation of medicines and vaccines?
4. AI algorithms: How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?
5. Inspection harmonization: How can the industry and regulators harmonize the implementation and interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (GMP), especially the Annex 1 on the manufacture of sterile medicinal products?
6. Supply chain management: How can the industry and regulators improve the resilience, transparency, and security of the global pharmaceutical supply chain, especially in the post-pandemic context, where the demand and supply of medicines and vaccines are subject to unprecedented fluctuations and disruptions?
7. Structuring the data: How to address the terminology when submitting data to different regulatory agencies? How to harmonize the data? What kind of standard should be used?
 
We invite all the participants to share their questions on these topics and engage in a constructive and productive dialogue on charting the direction for innovation in the industry to embrace the future that is now!

Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back! The tournament will take place at 12:00pm on 16 October at Celebration Golf Club. Proceeds from the event directly benefit the ISPE Foundation whose mission is “fueling global health equity by fostering access to knowledge and nurturing diverse talent.”   Prior to the shotgun start, lunch will be provided and an awards ceremony filled with exciting giveaways will conclude the day. A wide range of exciting sponsorship levels are available to meet your organization's unique preferences and objectives. To learn more about sponsorship opportunities please contact Dave Dunham (ddunham@ispe.org).

In this training, you will be led through the APQ guide series for Quality Management Maturity including how to leverage structured tools using a tested industry best-practice approach to coordinating, conducting, presenting, and reporting out on assessment outcomes. You will learn how the APQ methodology is used to improve the current state of quality and how it can benefit your organization through the Assess, Aspire, Act, Advance Framework.

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. This classroom course has been updated to include the new revised GAMP® 5 Second Edition.

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.