AAV Gene Therapy Specific Regulatory Guidelines for Companion Diagnostics

Time: 1:30 pm
day: Day 2 Track B PM

Details:

  • 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 other

Speakers:

Natasha Thorne
Natasha Thorne 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 Read more