Agenda
Our comprehensive education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharmaceutical industry.
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ISPE International Emerging Leader Hackathon Day 1
Registration Open
Registration Open
ISPE International Emerging Leader Hackathon Day 2
Women in Pharma Workshop
Optimizing Cost of Goods for Cell Therapy Production
Robust Quality Management Maturity: APQ and FDA
Technology in Alignment with EU Guidance & eClinical GPG
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.
Practical Implementation of Digital Transformation
Sunday Social
2024 FOYA Banquet and Awards Celebration
15th Annual ISPE 5K Run/Walk
Continental Breakfast in Foyer
Registration Open
Welcome to the ISPE Annual Meeting & Expo
Remarks from the Executive Chair
Keynote - Title Coming Soon!
Diary of a Rett Mom
Conference Highlights
Expo Hall Open
ISPE Career Center in the EXPO Hall
Networking Break in the Expo Hall
Whole Life Carbon & Pharma Manufacturing Exemplar Study
FDA Oversight of Drug Quality – 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.
Lifecycle Management Considerations for C&G Therapy
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.
Guiding Principles for Combination Product Reliability
Overcoming Challenges of Digital Innovation (AI)
Use of Physiological Biopharmaceutical Based Models
Navigating Regulatory and CMC Challenges in the Transition
Harnessing the Power of AI for Quality
Our Journey Towards Low Embodied Carbon Facilities
Advanced Analytics for Alarm Prioritization and Management
ATMP Regulatory Collaboration & Organizational Readiness
Translational Technologies and Precision Medicine
How Digitization Compliments Quality Decisions
Realizing Our Bold Sustainability Ambition
How AI Enables the Establishment of True CPV
Networking Lunch in the Expo Hall
Transformational Efficiency in Next-Gen Facilities
Global AI Healthcare Regulations: Trends and Future
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.
Leading a Culture of Collaboration and Growth
2024 Facility of the Year (FOYA) Category Winners Showcase
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.
ISPE Guide: ATMPs – Allogeneic Cell Therapy
ReVAMP Drug Supply Chain Consortium Progress and Outlook
Lessons Learned - Flexible Cell Therapy Facility Designs
Innovation Roadmap; Engineering as a Scientific Catalyst
The Human Side of Manufacturing
A “One-Click” Submission with AI and Digital Authoring
Drug Shortage Prevention: Where are we?
Global Post-Approval Changes and 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.
Impactful Technical Leadership in a Changing World
Artificial Intelligence in Good Manufacturing Practices
The Power of Risk Management to Unlock Validation 4.0
Protecting our Patients, Protecting our Planet
Networking Break in the Expo Hall
Be Ready: Scope 3 and Product Sustainability at Sites
Introduction to Digital Tools
Phase & Risk Based Approaches to Enhance ATMP Validation
State-of-the-Art Design & Construction of Biopharma Plan
The Quality Risk Management
ISPE Baseline Guide for Oligonucleotide Facility Design
Trends in Injectable Manufacturing Investment Strategy
Digital Tools - Panel Discussion
CDMOs—Swift Patient Access with CQV & Project Management
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.
Legal Citation of Compliance Data
FDA Oversight of Drug Quality – Compliance
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.
Case Study - rAAV - Changing Bioreactor Models / ScaleUp
Design in the Ballroom: A Risk Based Strategy
GxP Activities with Digital Tools
The Simplicity of Sustainability
Welcome Reception in the Expo Hall
Women in Pharma Monday Night Event: Masked Connections
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.
Registration Open
Continental Breakfast in Foyer
Women in Pharma Self-Defense Class
Opening Remarks
Giving Back to the Industry – ISPE Foundation
Keynote Presentation - Title Coming Soon!
(E)merging Tech & Talent: Spark’s Innovation & Investment
ISPE CaSA Chapter Insights
Expo Hall Open
ISPE Career Center in the EXPO Hall
Networking Break in the Expo Hall
Advances Needed to Expand Cell & Gene Therapies Adoption
Regulatory Considerations on Complex APIs Sameness
Sustainability - European Regulations for 2025
When it Happened: Considerations in Disaster Recovery
AI/ML Strategy and Opportunities in in Tech Ops
Building a More Resilient Public Health Industrial Base
DI by Design through Automated Data Capture Strategy
GxP System Periodic Monitoring Process Automation
Decentralized Pharma
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.
Current Trends in In-Country Testing of Medicines
Digital Twins and AI in Bioharma Manufacturing
FDA Oversight of Drug Quality - 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.
Is the EMA GCP CSV Guideline a blueprint for other GxPs?
Sustainably Controlling Odorous Off-Gas from Production Repl
The Matrix Approach: Revolutionizing Aseptic Filling?
Membership Meeting and Awards Lunch - Open to All Attendees
Networking Break in the Expo Hall
Panel: 503B Compounding & ISPE Guide
Expediting Affordable & Available Therapies for Patients
Unpacking Recent ICH Guidelines
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.
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
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.
Flexibility & Sustainability in Pharma Manufacturing
Tuesday Night Celebration
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!
Registration Open
Continental Breakfast in Foyer
Opening Remarks
ISPE Regulatory Groups: Driving Harmonization and Quality
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.
Fireside Chat: Pharma Regulation & Innovation Outlook
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.
Global Regulatory Town Hall: Future is Now
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!
Closing Keynote
Closing Words and Adjournment
Annual ISPE Foundation Golf Tournament
Advancing Pharmaceutical Quality Training Course
GAMP® Basic Principles Training Course
Commissioning & Qualification Training Course
GAMP® Data Integrity 21 CFR Part 11 Training Course
Advancing Pharmaceutical Quality Training Course (Cont.)
GAMP® Basic Principles Training Course (Cont.)
Commissioning & Qualification Training Course (Cont.)
GAMP® Data Integrity 21 CFR Part 11 Training Course (Cont.)
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.
Programme Changes
Programme is subject to change. Last minute changes due to functional, private, or organisational needs may be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme.