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Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.
Ideal for professionals in leadership roles, compliance officers, and those seeking to enhance their influence within a team, this workshop will delve into essential areas such as trust-building, emotional intelligence, and fostering team confidence. The session will feature engaging icebreaker activities and will culminate in an insightful panel discussion with FDA representatives and other compliance experts.
Workshop Agenda:
Adaptable Leadership
Explore strategies for developing leadership skills that can flexibly adapt to changing environments and challenges.
We are all Humans – Regulatory Interaction
Gain insights into effective audit practices, focusing on behaviors that foster cooperation and ensure compliance.
Team Building and Emotional Intelligence
Engage in activities designed to enhance trust, communication, and emotional intelligence within your team.
Fostering Team Confidence
Learn techniques to inspire and build confidence among your team members, empowering them to excel in their roles.
Panel Discussion with the FDA and Other Compliance Professionals
Participate in an interactive discussion with leading experts, including representatives from the FDA, on best practices and emerging trends in compliance, moderated by Yolanda McLean.
Merck Chemicals GmbH
FDA
Alnylam Pharmaceuticals
FDA
FDA
Moderna
COMECER
Genesis AEC
Skan US
United Therapeutics
Genesis AEC
Genesis AEC
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. OUTLINE
13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 Real World Data / Real World Evidence
*Attendees of the Sunday Social (up to 100) will receive an exclusive giveaway bag of ISPE items when visiting the Membership table during the event. These free giveaway bags are available on a first-come, first-serve basis and are limited to 100.
www.rettrevealed.com/adventuring-with-magnolia/
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Welcome Reception by the CaSA Chapter at Booth #813
FOYA Booth #1117
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.
Particle control in cellular ATMPs (Advanced Therapy Medicinal Products) presents a unique challenge to the industry. This presentation will cover a lifecycle approach to understanding and controlling the presence of particles in your product, integrating both regulatory requirements and quality considerations to ensure compliance and product quality
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
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.
Join us for an engaging and interactive session led by Dave DiProspero, featuring esteemed FOYA judges and category winners as they delve into the intricacies of their 2024 FOYA award-winning facility projects. Through a dynamic roundtable type panel discussion, we'll uncover the motivations behind FOYA submissions, dissecting the challenges faced and the innovative award winning solutions devised. From forging strong partnerships to embracing patient-centric design, each various aspects of project development and execution will be explored. This interactive session isn't just about celebrating achievements—it's about sharing insights and lessons learned to inspire future excellence in facility projects. Don't miss this opportunity to interact and gain firsthand knowledge from industry leaders and key players, shaping the future of pharmaceutical facility design, construction and operations.
CSL Behring
Amgen Inc.
Eli Lilly Kinsale Limited
Takeda Austria GmbH
United Therapeutics Corporation
Zydus Lifesciences Ltd.
CRB
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.
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
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.
Gilead Sciences
Sanofi
Veqtor
Sanofi Aventis
Kindeva Drug Delivery
U.S. Food and Drug Administration (FDA)
Strike Graph
No Deviation Pte Ltd
Gilead Sciences
Sanofi
Veqtor
Sanofi Aventis
Kindeva Drug Delivery
U.S. Food and Drug Administration (FDA)
Strike Graph
No Deviation Pte Ltd
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Emerging Leader Social at Booth #105 (Students & Recent Graduates are also welcome)
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
Sponsored by AstraZeneca
Join us for an evening of art, history, and culture as Women in Pharma® gathers once again in celebration of accelerated equality and inclusivity within our industry. Throughout the two-hour event, you’ll immerse yourself in the ambiance of Italian culture, enjoying cocktails, Italian cuisine, conversations, and appreciating the rich history and cultural significance of the masquerade tradition dating back to the 15th century Venice. Veiled behind your mask, relish the freedom of anonymity, fostering uninhibited exchanges and forging genuine connections. As the night unfolds, masks will be shed, unveiling identities, paving the way for the exchange of business cards, and the cultivation of professional ties, fortified by the shared bond of ISPE’s Women in Pharma.
Please note: All attendees must wear a Venetian-style mask throughout the duration of the event. We highly encourage masks to be elaborate and decorative, covering the eyes and nose area, but should not obstruct vision or impede conversation.
Discover the art of navigating these tides with Abbas Yar-Khan, Lilly's Group Vice President of Global Parenteral Products and Devices. Dive into an inspiring session where agility meets urgency and learn how Lilly's accelerated efforts are shaping a healthier future for patients across the globe.
Spark Therapeutics developed and launched the very first gene therapy for a genetic disease approved in both the US and EU. As a leader and driving force in gene therapy, Spark is continually evolving ahead of the industry and working to achieve its vision of a world where no life is limited by disease. Join Chris Stevens, Spark’s Chief Patient Supply Officer, for an in-depth conversation on how Spark is:
- Developing emerging technology and platforms with inherent adaptability; - Building capability and the talent Spark needs for today and tomorrow; - Investing and innovating in Philadelphia; and - Bringing their new Gene Therapy Innovation Center to life in West Philadelphia in the heart of University City.
Spark is on a mission to unlock the power of gene therapy to accelerate healthcare transformation. Chris will share how he and Spark’s Patient Supply Organization are making that mission a reality via (e)merging tech and talent, innovation and investment in the city of Philadelphia.
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Grant Recipient and Board Member Meet & Greet at Booth #813
FOYA Booth #1117
Manufacturing of mRNA offers great benefits. The therapeutics produced can be treatments for infectious diseases or used for personalized medicine due to their flexibility, cost, and speed of development. But there are still challenges to overcome to fully realize their potential especially when it comes to small-batch manufacturing. Considering manufacturability and scale-up from the beginning of development will help deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss small batch manufacturing solutions and how digital technology can help accelerate therapeutic development. We’ll also describe strategies to adopt a paper-free approach at all stages of development. Key points: Small and flexible manufacturing allows optimized solutions for personalized therapeutics and small-batch manufacturing. Digital technology can support mRNA therapeutics by helping to accelerate batch release and improve compliance. Using paper during development can carry hidden costs.
This presentation will focus on transformative initiatives within Office of Quality Surveillance (OQS) in FDA's Center for Drug Evaluation and Research (CDER) aimed at enhancing and modernizing the agency's approach to drug quality oversight. OQS plays a pivotal role in safeguarding dug quality by leveraging various data sources and analytical methods to monitor, assess, and report on the state of drug product quality and manufacturing facilities. The OQS speaker will discuss key advancements and implementation of innovative programs that enhance FDA’s oversight of drug quality. These programs include the New Inspection Protocol Project which streamlines inspection processes; the Drug Quality Sampling and Testing Program which ensures that the drugs sold in the US meet rigorous standards; and the Quality Management Maturity Program aimed at elevating industry quality oversight. Attendees will gain insights on how these programs enhance FDA’s quality oversight and encourage continual improvement from manufacturers.
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 the world of biopharma manufacturing, effective Deviation Management is the cornerstone of quality and efficiency. Traditional manual methods are not only labor-intensive but also susceptible to errors, leading to recurring quality issues.
Join us as we explore:
1.Quality Processes and Systems: Dive into the intricacies of quality management, uncovering the challenges posed by manual deviation handling such as subjectivity, repeat deviations, and inconsistent root cause analysis. Learn how to overcome these hurdles and streamline your processes for better outcomes.
2.AI Strategy and Execution: Discover the cutting-edge innovations in AI and GenAI and see how integrating these advanced technologies with your existing quality systems can transform your operations. Witness firsthand how AI could minimize repeat deviations, enhance productivity, compliance, and most importantly, work diligently towards patient safety.
Join us as we explore how AI can enhance your deviation management practices and elevate your biopharma manufacturing to new levels of excellence.
Join us on Tuesday, October 15th, immediately following the Membership Meeting and Awards Luncheon, for a decadent Dessert Reception in the Expo Hall. Satisfy your sweet tooth and mingle with industry peers at our delightful Dessert Reception, all served in the vibrant ambiance of the Expo Hall. This event is your chance to unwind, connect, and enjoy the final moments of this year's Annual Meeting & Expo.
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game Winner Announcements
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
FOYA Booth Meet & Greet at Booth #1117
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
Amicus GMP Consultants
Lachman Consultant Services, Inc.
Leiters Health
FDA
STAQ Pharma Inc
Novavax
IPS-Integrated Project Services, LLC
Amgen, Inc. - Thousand Oaks, CA
CRB
AbbVie, Inc.
Lonza
FDA
HDR COMPANY LLC
United Therapeutics
Johnson & Johnson
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.
Pfizer, Inc
GlaxoSmithKline
AstraZeneca
Bristol-Myers Squibb
Health Canada
FDA
Amgen Inc.
PMDA
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.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
Sanofi
Bristol Myers Squibb
U.S. Food and Drug Administration (FDA)
Deloitte & Touche LLP
CAI
The Triality Group, LLC
Sanofi
The digitization of the pharmaceutical industry’s manufacturing process is a critical step towards enhancing quality and productivity. This transformation allows for better knowledge management, accelerated innovation, and improved data security, while reducing time to market. Digitalization can be accelerated with AI to enable full integration of supply chains and improve operational processes, making them more adaptive and responsive. In terms of quality improvement, digitization and automation have resulted in a more than 65% reduction in overall deviations and over 90% faster closure times. Moreover, it has led to a 30 to 50% reduction in deviations, a 25 to 40% increase in plant capacity, a 15 to 20% reduction in lead times, and a 30 to 50% increase in direct and indirect plant operation productivity.
As a result, digitization is not only improving the quality of pharmaceutical manufacturing but also driving significant operational enhancements. It is imperative for the pharmaceutical industry to continue this digital transformation in manufacturing to match the pace of their R&D efforts.
From Chaos to Control: Streamlining Calibration and Maintenance for Global Operations
Inefficiencies stemming from fragmented systems, inconsistent processes, and labor-intensive manual tasks in calibration and maintenance are prevalent challenges in regulated industries. These issues can result in significant operational costs, compliance risks, and productivity losses.
This session will explore how Siemens Healthcare addressed these challenges by implementing best practices for the management of calibration and preventive maintenance across multiple global sites. Learn how the organization improved process standardization, enhanced operational efficiency, and realized over $3 million in annual cost savings while strengthening compliance and audit performance.
This session will provide valuable insights for organizations seeking to enhance operational efficiency, reduce costs, and ensure regulatory compliance across their maintenance and calibration activities.
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!
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.
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!
CBER/FDA
Spark Therapeutics, Inc.
EMA
NGT Biopharma
Gilead Sciences
Health Canada
Pfizer, Inc
PMDA
Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry
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.