De-risking cell therapy product development: strategies for commercial success

Chad is an Associate Director for the Manufacturing Sciences and Technology (MS&T) team which supports the cell therapy CDMO business. He obtained a Biological Sciences degree from the University of Nebraska and began his career in biopharmaceutical manufacturing in 2001. Since, he has held multiple roles in a wide range of biopharma organizations and has experience in early phase through commercial manufacturing operations. Chad is experienced in all aspects of biopharmaceutical production and has a complete understanding of FDA and EU regulations for biologics manufacturing.

Alex Sargent – better known as “Sarge” – is currently the Director of Process Development at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. After a brief stint in academia at the Cleveland Clinic, he left Cleveland to pursue his industry career in cell therapy. During his many years in this industry, he has had the honor of working at several esteemed enterprises on new technologies and approaches for cell therapy scale up, automation, and gene editing. He is especially passionate about the challenge of curing cancer, working on CAR-T and CAR-NK cell therapy process and analytical development from discovery, through regulatory submission, manufacturing, and pivotal clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.