Cellular Immunotherapy in the Real World: Toxicity

This is the recording and slides of the session presented live at the 2021 AcCELLerate Forum: Creating a Sustainable Ecosystem of Cell and Gene Therapy. The event aired live on Friday, November 19, 2021. Topics include:

• Toxicity: real world evidence and presentation from FDA
• Toxicity capture in the pre commercial setting
• Advancement in toxicity assessment and management
• Tracing of toxicities of off the shelf products
• New toxicities: HLH, Guillain-Barre, and GVHD

Session Chairs: Dr. Marcelo Pasquini, MD, MS (CIBMTR and MCW Cancer Center), Dr. Joy Aho, PhD (NMDP/Be The Match and Be The Match BioTherapies), and Dr. Tania Jain, MD, MBBS (Johns Hopkins University and ASTCT)

Speakers: Yonatan Negash (FDA), Dr. EJ Shpall, MD (MD Anderson Cancer Center), Dr. Nirali Shah, MD, MHSc (National Institutes of Health), Dr. Bianca Santomasso, MD, PhD (Memorial Sloan Kettering Cancer Center), and Dr. Rafael Amado, MD (Allogene)

Additional Panelist: Dr. Stephan Grupp, MD, PhD (Children's Hospital of Philadelphia), Dr. Jina Shah, MD (Kite Pharma), Dr. Bindu George, MD (FDA), Dr. Kimberly Schultz (FDA), Dr. Xiaofei Wang, PhD (FDA), and Matthew Foster (FDA)