FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T Cell Therapies

FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T Cell Therapies
Silver Spring, MD, USA
September 24, 2019 – September 25, 2019
US Food and Drug Administration

ITC Workshop Image_September 2019

The goal of this workshop is to discuss the preclinical and translational safety assessment of engineered T cell therapies. The workshop will focus on six topics, followed by an in-depth discussion:

  • Designing engineered T cells for optimal activity and safety
  • Target expression and associated liability assessment
  • In vivo models informing safety and activity
  • Safety of viral and non-viral gene delivery systems – utility, risk of genomic injury
  • Linking preclinical development with the clinical experience
  • Regulatory considerations

 

Agenda: Please find draft agenda here.

Accommodations: Click here to find a list of nearby hotels. Please note that participants are responsible for their own transportation to and from the US FDA site.

Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).

Registration: Click here to complete online registration. Upon registering, participants will have the opportunity to provide up to three questions that they would like to see addressed during this workshop. Registration will close on September 18, 2019 at 5:00 PM EST.

Webinar: Click here to join the webinar.