A key factor in the success of a developing drug or therapy is the success of early clinical trials. A focus on Good Manufacturing Practice (GMP) standards for phase 1, first-in-human trials is critical to maximize the chances of success from a project’s start. For cell therapy development, where even small errors can make a big difference, it’s even more important.
Dr. Murat Kalayoglu, Co-Founder and CEO of Cartesian Therapeutics, has observed how regulatory and GMP standards have evolved over the years throughout her career. Cartesian is a fully integrated, clinical-stage biopharmaceutical company developing novel cell and gene immunotherapies. Dr. Kalayoglu was previously CEO of Topokine Therapeutics, acquired by Allergan in 2016.
Dr. Kalayoglu recently sat down with The Business of Biotech podcast to talk about how the cell therapy space should approach phase 1 clinical trials, from raw material management to interpreting guidance and early-stage manufacturing.