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.

Webinar: Information coming soon.