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Session 7 Track 1 and 2: Gene Editing
Session Chair(s)
Scott Vafai, MD
Vice President, Translational Medicine, Verve Therapeutics, United States
David Cantu, PHD
Biological Reviewer, CBER, FDA, United States
This will be a joint clinical and non-clinical session on gene editing. The session will begin with an overview of the FDA guidance on human genome editing to provide an overview of the recommendations for sponsors developing such products. The subsequent talks will be from sponsors actively working in this space and will include two presentations on nonclinical development topics and one presentation on clinical development.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the latest guidance from FDA on the development of gene editing products
- Gain insight into unique nonclinical considerations for the development of gene editing products
- Understand how sponsors are approaching clinical development of gene editing products
Speaker(s)
David Cantu, PHD
Biological Reviewer, CBER, FDA, United States
Nonclinical Considerations for Gene Therapy Products Incorporating Human Genome Editing: An FDA/CBER Perspective
Jonathan Phillips, PHD
Vice President, Pharmacology & Toxicology, Intellia Therapeutics, United States
The Modularity of an In Vivo CRISPR-based Therapeutic Platform
Olubunmi Afonja, MD, MBA
Vice President, Clinical Development, Editas Medicine, United States
Evaluation of Reni-cel, an Investigational AsCas12a Gene-edited Autologous Cell Therapy, in Patients with Severe Sickle Cell Disease Treated in the TUBY Trial
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