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Dr. Shon Green, a Cell and Gene Therapy consultant, will present on nonclinical development strategies for CAR-T therapies. 

Dr. Green trained at UCB and UCSF where she developed and employed preclinical models of cancer to study tumor development and potential therapeutic approaches. She then spent over a decade developing T cell-based immunotherapies for oncology, and more recently autoimmune diseases. Her expertise in cell therapy drug development span autologous CAR- and TCR-engineered T cells, epigenetic and genetic enhancements of T cell function, allogeneic approaches, iPSC-derived products, NK cell engineering, and in vivo CAR T cell engineering. Focused on cutting-edge innovations at small to mid-size biotech companies, she guided multiple novel therapeutics through preclinical and CMC development to clinical testing. Currently she consults companies in the Cell and Gene Therapy space while working on launching a new startup biotech that aims to cure severe allergies with in vivo CAR technology. 

Key Takeaways

• Understanding the CAR-T drug modality, unique attributes and complex MOA

• Overview of considerations specific to emerging in vivo CAR-T approaches

• Regulatory requirements for demonstrating nonclinical efficacy and safety

• Selection of in vitro and in vivo models for IND-enabling data packages

• Case study demonstrating a successful IND package for a novel CAR-T