The 2024 ISPE Annual Meeting & Expo is poised to herald a transformative era in pharmaceutical science and manufacturing. The increasing impact of new technology, treatment modalities and digitalization such as artificial intelligence (AI) and machine learning (ML) in the pharmaceutical industry has sparked interest in many areas of development and CMC. More than ever, an emphasis on cross discipline collaboration is needed for these groundbreaking technologies to be implemented and accepted worldwide. This year’s event also seeks to illuminate their profound impact on organizational readiness and the workforce of the future. By fostering global discussions centered on excellence, modernization, and harmonization, we aim to prepare pharma professionals for the challenges and opportunities of an evolving industry landscape.
Our comprehensive education program offers cutting-edge technical sessions, shedding light on the latest advancements in areas like supply chain, operations, facilities, and regulatory affairs, but also emphasizing the role of data science including model-informed drug development (MIDD) and technology in shaping the future of product development, production systems, and quality assurance.
This signature gathering is not just an opportunity to learn but also to connect. From emerging talents to seasoned executives in drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies, attendees will get the chance to network, exchange insights, and preview the latest technologies and services at our expansive Partner Showcase.
The importance of a resilient, agile supply chain, as well as strong collaboration between industry and regulators is well recognized. Despite these learnings, an aging population and an unprecedented rise in chronic diseases mean that the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader to set the pace for knowledge sharing that speaks to both current and future needs of the industry.
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. Technical challenges in the manufacture of these products are at the forefront of this complex environment, compounded by different health authority expectations from around the world. Opportunity for international harmonization, alignment, and best practice application exists as this novel area continues to grow within the industry to ultimately help serve patients in need.
Computerized systems have progressed from basic feedback-based control and data capture tools supporting human activities to intelligent and adaptive systems ultimately capable of way more than their human designers. This AI and digitalization revolution offers so much potential for efficiency gains and innovation within our industry, but careful consideration is needed to identify and mitigate the risks associated with increased reliance on computerized systems. This track will focus on holistic approaches to implementing and managing the technology, adapting the company culture and processes, and creating synergy with a workforce to embrace the inevitable and necessary changes brought about through a true digital transformation.
Applying innovative approaches to manufacturing and design solutions to ensure quality therapeutic products are brought to market in an efficient and cost-effective manner to improve patient health. This includes streamlining operations and support functions, process improvements, and ensuring relevant technologies are implemented, while focusing on upskilling and reskilling the workforce to support the future state of our industry.
Advances in technology and innovation are reshaping the landscape for Regulatory, Compliance and Quality. For example, the application of AI/ML alongside with sophisticated modeling techniques are catalyzing drug development for new and existing modalities. Participants in this track will hear from regulators working on novel ways to effectively collaborate and explore reliance initiatives that may benefit from a global perspective. Learn from industry leaders on approaches that may help introduce complex technologies and innovative medicines faster to patients around the world. Engage with peers and regulators in discussions that explore solutions to these challenges!
This content area combines Supply Chain Resiliency with Sustainability to create an opportunity for these closely related topics. Sustainability is a core policy for many companies and a key goal for many projects. Whether building at a new site or implementing a global sustainability policy, there are approaches and lessons learned that can benefit the industry as a whole. Sustainability aims to prioritize emission footprint reduction, resource efficiency, ecosystem protection, health, and wellbeing. Submissions focusing on sustainability should detail the challenges and successes of projects and corporate actions that minimize the footprints of carbon, energy, water, waste, and ecosystem impact, both in facility design/construction and in the products we produce.
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
