The regulation of cell therapy

Interviewer: Moutih Rafei, thank you very much for joining us today for an interview on the regulation of cell therapy. Cell therapy is a rapidly advancing field that has the potential to target previously untreatable conditions in multiple therapeutic areas. This includes regenerative medicine, immunotherapy, cancer therapy, and others. Now the fast pace of innovation in cell therapy and the use of living cells, which are inherently complex and difficult to standardize, pose some unique challenges from a regulatory perspective, and we would like to discuss those challenges with you today. To start things off, can you provide a quick overview of the current state of cell therapy? Specifically, what types of cell therapy are available or under development, and what are some of the key therapy areas that they are targeting? Prof. Rafei: Well, thank you very much for the invitation to discuss the regulation of cell therapy. In fact, cell therapy is becoming a big field. It's been booming over the last decade, simply because, as you mentioned, it's highly relevant to fields like regenerative therapies or medicine, as well as anything that targets cancer in general. So far, the field of cell therapy is divided into two main areas or axes, if I may say. The first one is the so-called stem cell-based therapies, and that really includes any usage of pluripotent stem cells, as well as adult stem cells. That's mostly what we hear about in terms of, for example, targeting hematopoietic stem cells, neural stem cells, mesenchymal stem cells, and these are really made for regenerative medicine