Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives

Description: Announced in December 2024, FDA delivered on their promise to support platform technologies with the newly announced Advanced Manufacturing Technology (AMT) designation program. The AMT program has captured the interest of both platform drug developers and equipment manufacturers, who are able to utilize the program to accelerate their products into initial Investigational New Drug (IND) filings and clinical trials innovative medical platforms into clinical reality. The regulatory landscape for novel medical platforms is rapidly evolving, with FDA's AMT designation emerging as a powerful tool for expediting the path to clinic. As a seasoned regulatory affairs team serving hundreds of customers across the globe as well as our own internal innovation teams, we are excited to share our early experiences and insights into harnessing the potential of AMT to fast-track innovative medical technologies into the clinic.
This session will empower professionals to proactively embrace the opportunities presented by AMT “platform” designation, driving innovation and expediting the delivery of groundbreaking medical technologies to patients in need. Drawing from early experiences across a range of manufacturers and drug developers preparing for AMT filings, we will explore the regulatory landscape, challenges, and successes encountered in leveraging AMT to accelerate novel technologies to market. Attendees will gain insights into navigating the regulatory process, fostering collaborative partnerships, and maximizing the potential of AMT designation to expedite the development and commercialization of cutting-edge medical technologies.
Together, we will unlock the potential of AMT and propel the healthcare landscape into a new era of accelerated progress and transformative impact. This talk will provide a comprehensive overview of the regulatory environment, emphasizing the pivotal role of AMT in streamlining the approval process for advanced manufacturing technologies. Through real-world case studies and practical examples, attendees will gain invaluable knowledge about navigating intricacies of AMT designation to accelerate their programs.