Nonclinical considerations for cell and gene therapies

With nearly a dozen or more products commercialized globally and approximately 1000 clinical trials underway as of the end of 2018, cell and gene therapies are significant component for drug development. Within this evolving regulatory environment dealing with a unique and complex nature, cell and gene therapy candidates present significant development challenges. This webinar focused on nonclinical studies required or expected for IND/IMPD submissions and beyond. It also described how advanced therapies are defined and presented preclinical study and regulatory/safety considerations and strategies for assessing advanced therapies.