Session Details

Excitement and investment in cell and gene therapies (CGTs) continue to intensify, as these therapies are at the frontier of personalized and precision medicine and have the potential to revolutionize healthcare. However, the clinical development process (i.e., bridging cell and gene therapy to market), primarily taken on by the bio-industry, has faced clinical challenges linked to safety concerns and perceptions of CGTs. Addressing these challenges requires a collaborative effort from researchers, clinicians, regulatory bodies, and industry partners. In this symposium, our speakers will discuss approaches and solutions to address specific clinical development issues, including, (1) clinical development mitigation strategies around selection of clinical sites and jurisdiction requirements, (2) alternative technologies to improve safety and efficacy, and (3), the importance of data sharing to help strengthen regulatory decisions, generate new hypotheses, and increase scientific knowledge.