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Presenting Subject Matter Experts from BMS, Eli Lilly, Sanofi Aventis, Amgen, Gilead, Genentech, Spark, Syneos, United Technologies
Hear from thought leaders regarding their ability to harness and scale the power of AI to advance the real time access to key quality indicators, data analytics, and automated real time trending, essential elements in the advancement of continuous improvement initiatives and enabling Sr. Management review of ongoing quality performance.
Advance your understanding of real digitization strategies that enable a harmonized corporate level alarm and response program to advance quality culture and continuous improvement of quality performance.
Witness the use of advanced data analytics and AI tools to assemble data from across Manufacturing & Supply, Supply Chain, QA, Regulatory, Clinical Operations, R&D into one accessible location, using the power of AI and related tools to deliver actionable insights to inform critical decisions.
Review Lessons learned in the advancement of digitization strategies that improve operational efficiencies in capacity, productivity, and environmental sustainability will be shared. Facilities that harnessing smart communications between packaging equipment like automated storage and retrieval systems (ASRS), automated guided vehicles (AGV), manufacturing execution systems (MES), and laboratory information management system (LIMS) are key components for integration and associated efficiency gains.
At the 2024 ISPE Annual Meeting & Expo, you can expect to:
- Accelerate regulatory submission and review timelines and growing patient demand via a proposed technological shift utilizing structured content and generative AI (GenAI).
- Experience new approaches incorporating AI and structured content in regulatory affairs while advancing the necessary shift towards more dynamic and technology-driven processes.
- Become conversant in the world of digital tools in pharmaceutical manufacturing and explore the deployment of digital validation tools, automated testing and monitoring tools, and innovative training tools that are shaping the future of the industry.
- Experience shared learning Technical Operations experts on the application of Machine learning/Artificial intelligence (AI/ML) and the integration of digital transformation, advanced data analytics, and operational excellence, and use cases in the regulated pharma industry.
Engage with international regulators, subject matter experts, and ISPE experts, as they discuss evolving scientific and regulatory perspectives and responses to industry advancements and novel therapeutic approaches to supporting global patient populations.
Build your knowledge of the FDA and its 2024 organizational structure through the understanding of recent changes. Changes to the Quality Assessment Office and the Office or Regulatory Affairs are meant to removed duplicity and create a more streamlined, agile and flexible organization reinforcing the connections between assessment, inspection, surveillance, research and policy operations, and provide more clarity and promptness in enforcement actions for industry. These changes, in conjunction with ongoing initiatives are intended to streamline and modernize FDA's internal review process, and should make FDA more adaptable to public health emergencies.
At the 2024 ISPE Annual Meeting & Expo, you can expect to review:
- ISPE’s Barriers to Innovation initiative began in 2023. This initiative, including industry surveys, results, and next steps will be shared.
- The successful development of combination products will require greater collaboration within the industry to overcome regulatory, clinical, and technical challenges. New tools of computational modeling and simulation will be featured in this discussion.
- A harmonized international regulatory landscape for the application of Artificial intelligence (AI) is far from achievable currently. The WHO perspective along with country specific approaches from the EU, UK, China, India Saudi Arabia, Japan & Italy will be shared. How AI systems used internally within companies through risk-based methodologies can effectively be applied will also be shared. ISPE’s industry leading drug shortage prevention model will be discussed. International regulatory perspectives are not harmonized and create challenges for companies regarding definitions/ approaches, reporting expectations, and risk management planning, all critical to preventing or responding to shortages. Learn how ISPE’s Global Convergence Opportunities team is focusing on key components in the interest of global patient populations.
- Global regulatory submission review timelines continue to be an opportunity for improvement. A comparison of the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets will be discussed, along with the implications of these differences relating to drug shortages. 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.
- 503B Pharmaceutical Compounding: 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 and FDA compliance. This session begins with a comprehensive overview of the ISPE Guide related to 503B compounding, setting the stage with foundational knowledge and industry standards. You 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.
- Abbreviated new drug applications and the “totality-of-the-evidence”: Hear from FDA and advice on the evaluation of abbreviated new drug application (ANDA). Key messages for industry include that 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. Key components of this approach will be discussed. A discussion on regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs will also be featured.
At the 2024 ISPE Annual Meeting & Expo, you can expect to review:
- 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 result in the need for additional capacity. Gain insights in the development of an ISPE facilities guide responding to this emerging platform of medicines.
Join us as we delve into the realm of lifecycle management considerations for cell and gene therapy products. As an attendee, you 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.
At the 2024 ISPE Annual Meeting & Expo, you can expect to review:
- Establishing a Particle Control Lifecycle: Regulatory and Quality Perspectives 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.
- Experience new approaches incorporating AI and structured content in regulatory affairs while advancing the necessary shift towards more dynamic and technology-driven processes.
- Hear from regulatory tested subject matter experts about the effective use of a multi-product facility can compliantly support multiple product modalities and avoid the need to retool on a regular basis, thereby avoiding costly capital investments and product development delays. Learn how multiple ATMP modalities have been successfully accommodated in the same facility and the steps taken to remain fully compliant.
- ATMP’s continue to evolve rapidly and the need for a solid control framework for avoiding contaminations is a key component in the strategy and facility design for both allogenic and autologous therapy applications. Learn from SME’s on the latest innovations for facility design, key design elements and solutions to common challenges.
- Product comparability issues with scaling gene therapies continue to challenge the industry highlighting the lack of thorough process understanding and process robustness when manufacturing novel products. ISPE is developing an rAAV.
- Comparability guide to aid industry in navigating challenges when changing the production bioreactor configuration and scaling up.