CAR T Manufacturing and Toxicity
Pre-Clinical Considerations
Genetically engineered therapeutics present diverse, and sometimes heightened, risks compared to traditional small molecule therapies. Robust clinical trial safety measures are critical for these developing technologies.
Find out what FDA guidance says about integrating gene delivery vectors, such as CAR T cells, and gene editing technologies (like CRISPR) in our white paper.
You’ll learn about:
- Addressing insertional mutagenesis risks
- Testing methodologies for purity, potency, and safety
- Long-term follow-up (LTFU) requirements
- First-in-human considerations
- And more
Download the white paper.
DATE
Time: 1 p.m. ET, 12 p.m. CT, 10 a.m. PT
Duration: 1 hour