For clinical trials that exclude patients with pre-existing antibodies to gene therapy product, FDA Guidance strongly recommends the contemporaneous development of a companion diagnostic (CDx). This presentation provides an overview of the CDx development process including partner selection, regulatory activities, and implementation of the CDx device (assay development, verification, analytical validation, and clinical validation). Additionally, challenges with CDx development for gene therapies will also be discussed.
Learning Objectives:
Appreciate current and future trends in companion diagnostics development for AAV-mediated gene therapy.
Describe how companion diagnostics are co-developed during the drug approval process and identify key requirements for development and implementation.
Recognize challenges with selecting a CDx partner, the evolving regulatory landscape, assay development and deployment, cost, and timelines, and how these factors impact CDx development during the drug approval process.
