Session Details

The goal of the session is to understand the regulatory requirements and basics of companion diagnostic (CDx) development. Adeno-associated viruses (AAVs) are commonly used for delivering gene therapies, but pre-existing immunity can preclude the use of these vectors in a subset of patients. CDx development is required for AAV-neutralizing antibody screening as well as for other diagnostic tests required for patient inclusion into a clinical trial. With the dramatic growth in the number of gene therapy clinical trials, more sponsors are realizing the challenges in navigating the requirements of developing a CDx in parallel with the clinical development of their gene therapies.