The Future of ATMPs: Insights, Opportunities, and Innovations at the 2024 ISPE Annual Meeting
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
Unprecedented opportunities abound as the field continues to evolve and industry learns more about existing and future potential technology advancements. Furthermore, these products represent a significant step forward in the treatment of patients and, in many cases, presents a unique patient benefit. This field is relatively new and less established as compared to traditional biotechnology fields. Therefore, both development and regulatory frameworks are evolving continuously in line with emerging information. It is important for the future development of these products that speed and agility are considered in the context of this framework. Towards this end, multiple companies are exploring highly integrated and automated manufacturing systems to aid in the advancement of these products.
The 2024 ISPE Annual Meeting & Expo’s track on ATMPs will provide a platform for pharmaceutical professionals to share insights, discuss challenges and opportunities, and learn about the latest advancements from industry and regulatory perspectives. This year's ATMPs-focused track includes 12 presentations on four topic areas related to ATMPs, including regulations, facilities, operations, and emerging technology, as well as a panel discussion titled “Expediting Affordable and Available Advanced Therapies for Patients Globally.” The carefully curated program aims to cover topics throughout the entire product lifecycle. Key takeaways from the ATMPs track include:
- Regulatory and development strategies: Insights into navigating regulatory challenges and development hurdles for ATMPs to streamline commercialization
- Advanced technologies and sustainability: A focus on advanced, sustainable technologies and facility designs tailored to ATMPs
- Industry collaboration and readiness: An emphasis on collaboration among regulators, manufacturers, and suppliers to accelerate therapy adoption, reduce costs, and enhance treatment delivery
Content in the ATMPs track will focus on the following areas:
ATMP Regulations: This content will outline the state of chemistry, manufacturing, and controls (CMC) in the cell and gene therapy space; strategic and innovative CMC approaches; and the importance of industry and regulator collaboration. Proactively addressing opportunities for improvement is crucial for successful market entry and the delivery of innovative treatments to patients. Featured presentations include "Lifecycle Management Considerations for Cell and Gene Therapy Products," "Establishing a Particle Control Lifecycle" by Stephanie Martin, and "ATMP Regulatory Collaboration and Organizational Readiness" by Alfred Penfold and Jon Halling.
ATMP Facilities: Attendees will benefit from gaining insights on facility design for new modalities. Facility design for ATMPs is often highly complex from a product and process perspective. The content will highlight the importance of sustainable practices, contamination control, and flexible facility designs to support scalable, efficient, and sustainable production while maintaining supply chain integrity and patient-centricity. Presentations focusing on this topic include "ISPE Guide: ATMPs – Allogeneic Cell Therapy" by Komal Hatti and Ian Moy, "Lessons Learned – Flexible Cell Therapy Facility Designs" by George Todorov and Andrew Applebury, and "Protecting our Patients, Protecting our Planet" by Omar Melendez and Maya DeHart.
Adapted from the ISPE Guide: ATMPs – Allogeneic Cell Therapy, the presentation titled “ISPE Guide: ATMPs – Allogeneic Cell Therapy” will cover manufacturing facility development and design for allogeneic cell therapies. Attendees will learn about contamination control strategies and multi-product processing, the allogeneic cell therapy manufacturing process, and key design elements for allogenic cell therapy facilities as manufacturing processes this nascent field continues to evolve. Attendees will learn about contamination control strategies and multi-product processing, the allogeneic cell therapy manufacturing process, and key design elements for allogenic cell therapy facilities as manufacturing processes this nascent field continues to evolve.
ATMP Operations: Covering a wide range of topics throughout the lifecycle, this content addresses validation, process development, scaling up, quality, comparability studies, and collaboration with contracted organizations. The session will also provide guidance to attendees on how a risk-based approach and holistic project management strategy are key to successfully bringing therapies from clinical development to commercialization. Attendees will benefit from presentations such as "Phase and Risk Based Approaches to Enhance ATMP Validation" by Biana Torres and Ryan Murray, "CDMOs—Swift Patient Access with CQV and Project Management" by Robin Newman and Gretchen Smith, and "Case Study – rAAV – Changing Bioreactor Models / ScaleUp" by Apurv Puri.
ATMP Emerging Technologies: In addition to product and process complexity, the vein-to-vein supply chain of ATMPs often poses high risks to product quality. Unique supply chain challenges may be addressed by digital solutions or decentralized manufacturing approaches. Presentations focusing on this content will also discuss advancements in aseptic filling which can help meet the stringent requirements associated with cell and gene therapies. Those will feature insightful topics such as "Advances Needed to Expand Cell and Gene Therapies Adoption," "Decentralized Pharma: Pioneering Patient-Centric Manufacturing" by Carol Houts, and "The Matrix Approach: Revolutionizing Aseptic Filling?" by Holger Kranenburg and Patrick Wieland.
“Expediting Affordable and Available Therapies for Patients”: The ATMPs-focused track will conclude with a panel discussion where industry and regulatory experts, including ISPE ATMP Communities of Practice (CoP) members, will discuss highly debated topics and weigh in with their experiences and perspectives.
Together, the many experts involved in content planning and presentations for this track share a common goal: to provide patients with high-quality, available, and affordable medicines. The program committee, speakers, and contributors all look forward to welcoming industry professionals and regulators to the ISPE 2024 Annual Meeting & Expo and its track-focused sessions.
