This year’s ISPE Annual Meeting & Expo will be held 26 – 29 October in Charlotte, NC, US, and virtually. In addition to the 60 plus hours of educational information, the Exhibit Hall will be home to more than 200 exhibitors presenting the latest technologies and advancements in the industry, and there will be ample opportunity to network and connect at events like the FOYA Banquet and Awards Celebration, Welcome Reception, and Tuesday Night Celebration.
The conference features more than 160 speakers with educational tracks focused on many of the most important issues facing our industry. Here are just a few highlights on the agenda.
Biologics Manufacturing
The need for biologic therapies is rapidly increasing due to their effectiveness in treating complex diseases, including cancer, autoimmune disorders, and rare conditions. Advancing biologics manufacturing is vital to produce safe, effective, and affordable therapies at scale—directly impacting patient health, business viability, and the ability to respond to evolving healthcare needs. On Monday 27 October, Wei Huang, COO, Henlius Biopharmaceutical Ltd. will present, “Novel Technology Applied in Biologics Manufacturing,” where she will discuss the technologies and strategies shaping the future of biologics manufacturing—a future defined by greater efficiency, quality, and accessibility through digital transformation. In her presentation she will give an update on the latest advances in continuous bioprocessing, real-time analytics, and AI integration—technologies which are at the forefront of modern biologics manufacturing.
Artificial Intelligence and Regulatory Compliance
The use of artificial intelligence (AI) and machine learning (ML) is changing our industry and shaping the future of regulatory compliance. Managing AI in regulated life sciences is crucial because it protects patients, product quality, and data integrity, ensures compliance, builds trust, enables innovation, and promotes industry-wide consistency. The industry, regulators, and the public must trust that AI can be used safely and transparently. Without clear guidance, adoption may be slow, uneven, or risk-averse, holding back innovation.
On Monday 27 October, Afrah Mujeeb, Regulatory and Quality Co-Op, Access Vascular Inc., will present timely, practical guidance on leveraging AI/ML for regulatory excellence, addressing ongoing challenges, and preparing industry professionals for emerging global standards and ethical considerations in AI adoption. In her presentation, “AI/ML in Regulatory Decision: Compliance & Innovations,” she will cover international perspectives and harmonization initiatives, and how, for example, major regulatory agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) are actively developing frameworks and guidance for AI/ML. The presentation will provide knowledge, tools, and strategies to safely, ethically, and effectively leverage AI/ML in regulatory contexts—helping companies gain a competitive edge, boosting compliance, and supporting better public health outcomes.
On Tuesday 28 October, Brandi Stockton, Founder, Managing Partner, The Triality Group, LLC, and Eric Staib, Vice President, Corporate Quality, Syneos Health will deliver a roadmap for leveraging AI in regulated GxP environments—promoting both innovation and compliance. Their presentation, “New GAMP® AI Guide Overview and Key Concepts,” will equip industry professionals with the knowledge, structure, and confidence to safely and effectively integrate AI into regulated processes, fostering innovation while safeguarding compliance and patient safety. It addresses a pressing need for clear, harmonized guidance on AI in regulated environments, where industry best practices are still emerging and regulations are evolving.
Successful Sustainability
Addressing the environmental footprint in pharmaceutical manufacturing is vital for protecting the planet, maintaining business viability, meeting stakeholder expectations, and shaping a more sustainable future for the industry and society. Pharmaceutical manufacturing consumes significant energy and resources, contributing to carbon emissions, water use, and waste production. Reducing environmental impact is essential to protect ecosystems and address the urgent challenge of climate change.
Sustainability should be at the forefront of decisions as we build new facilities or renovate existing ones. On Monday 27 October, Melanee Short, Head of Sustainability, Global Engineering, Sanofi, will demonstrate how innovative partnerships and gamification can create lasting change, drive measurable sustainability outcomes, and inspire other organizations to adopt similar approaches. Her presentation, “Leveraging Competition to Drive Sustainability,” will equip industry professionals with new ideas and potential methods to advance environmental sustainability, boost operational performance, and foster a culture of continuous improvement, helping the entire sector move toward a more sustainable future.
How Digital Innovations Can Advance ATMPs
Advanced Therapy Medicinal Products (ATMPs) have the potential to change lives and cure diseases that we previously thought were incurable, but the cost to develop and manufacture these therapies can be cost prohibitive. Scaling up autologous and allogeneic cell therapies is challenging due to variable processes, manual operations, and unpredictable patient-specific demands. Overcoming manufacturing bottlenecks in cell therapy is crucial because it directly impacts patient health, industry advancement, product quality, operational cost, and readiness for the future. On Tuesday 28 October, George Todorov, Senior Process Specialist, IPS, and Stephen Lane, Industrial Analyst II, Modeling & Simulation, IPS, will present, “Simulation-Driven Solutions for Cell Therapy Manufacturing Ramp-Up.” Their approach is noteworthy because it goes beyond theoretical discussion; it delivers proven, practical tools and strategies that could help the industry not only meet today’s manufacturing demands, but also future-proof plant design and operations for the rapid evolution of cell therapies. Attendees of this presentation will gain a potential roadmap for modernizing cell therapy manufacturing and a toolkit for production challenges—positioning companies to deliver better therapies, more efficiently, to more patients.
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