The historic August 2017 approval of the first chimeric antigen receptor (CAR) T-cell therapy put cell therapy into the spotlight, ushering in a new approach to the treatment of cancer. Now cell therapies are considered one of the most powerful tools in oncology and one of the most-studied investigative products. According to the Alliance
for Regenerative Medicine, as of the first quarter of 2019, there were 642 cell therapy clinical trials under way worldwide—including cell therapy and gene-modified cell therapy trials across all phases. Due to the currently high cost of CAR T-cell therapy (CAR-T), there is significant patient interest in gaining access to these treatments through clinical trials, adding a layer of competition to the already challenging process of product development.
In this white paper, we explore the current landscape of cell therapy, with an emphasis on CAR-T products, highlighting the key challenges and opportunities sponsors face as they endeavor to translate these treatments from the bench to the bedside.