Gene therapies represent a revolutionary treatment for complex disease pathologies with a hope for a once-in-a-lifetime treatment and complete cure. Leading edge therapies such as these are not risk free and the regulatory landscape built to ensure both the protection of the patient and delivery of efficacious treatments is quite dynamic. This talk will highlight some of the technical and regulatory challenges in this field to help the audience appreciate the challenges in this exciting environment.
Learning Objectives:
Gain an understanding of the general process for the development and registration of a companion diagnostic.
Appreciate Health Authority expectations for companion diagnostics.
Understand how Health Authority expectations impact the gene therapy field.
