Job title: Team Lead
Dr. Thorne has been involved in regulating companion diagnostics to gene therapies since she first started at the FDA seven years ago. Prior to the FDA, Dr. Thorne worked at the National Institutes of Health, where she was involved in projects to support the preclinical development of therapies to treat rare or neglected diseases.
AAV Gene Therapy Specific Regulatory Guidelines for Companion Diagnostics 1:30 pm
Outlining the Study Risk Determination process of CDRH and CBER in evaluating a CDx application Key regulatory considerations for accelerating the development of a CDx alongside an AAV gene therapy product Comparing PMA and HDE submissions: comparing and contrasting the required elements of both, and guidance for selecting one study route over the otherRead more
day: Day 2 Track B PM