Understanding the Regulation of Cell Therapy Products - On Tech Ethics

Discusses the regulation of cell therapy products and the importance of training on this topic.  Our guests today are Kathy Loper and Jared Schuster.  Kathy serves as the Director of Regulatory Affairs for NMDP, a nonprofit providing life-saving cellular therapies to patients. Kathy has extensive experience in biological product manufacturing and works closely with regulatory agencies, professionals, and other organizations to move the industry forward. Jared also has extensive experience in biotech, specializing in cell therapy CMC, regulatory strategy, and analytical development. He has held scientific, quality, and regulatory roles throughout his career, and is clinically certified as a Histotechnologist and Advanced BioTherapies Professional. At NMDP, he oversees regulatory CMC and strategy functions for cell and gene therapy programs, focusing on procurement of cellular starting materials.  Additional resources: NMDP: https://www.nmdp.org/ Regulation of Cell Therapy course: https://about.citiprogram.org/course/regulation-of-cell-therapy-products/ CITI Program’s course catalog: https://about.citiprogram.org/course-catalog