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
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.