Transfusion medicine advanced significantly during the 20th century, with its roots going back to the 1940s. The 21st century - and specifically the last decade - has been characterized by innovations focused on precision medicine driven by advances in genomics, data analytics, and targeted immunotherapies. This session will focus on these three innovations, and how the FDA approaches emerging technologies. More specifically, we’ll cover current and future genomic approaches to cancer therapies that have the potential to disrupt established transfusion therapy, the growth of targeted monoclonal antibody therapies (MATs), and new cellular therapies including CAR-T. We’ll then explore how Big Data can play a role in this innovation, with a focus on data interoperability and mining with an eye toward improved patient outcomes. Thirdly, we’ll hear the FDA’s current thinking on regulatory strategies that will guide and inform both providers and industry seeking the optimal approach for safe and effective adoption of new technologies. Join executive leaders to learn about these innovations and discuss strategies to leverage new knowledge and skills to advance the industry and patient care.
Please note: Celina Montemayor, MD, PhD did not consent to be recorded; therefore, the on-demand presentation and handout have been modified accordingly.