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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)
Nonclinical Considerations for Gene Therapy Products Incorporating Human Genome Editing: An FDA/CBER Perspective
David Cantu, PhD
FDA, United States
Biological Reviewer, CBER
The Modularity of an In Vivo CRISPR-based Therapeutic Platform
Jonathan Phillips, PhD
Intellia Therapeutics, United States
Vice President, Pharmacology & Toxicology
Evaluation of Reni-cel, an Investigational AsCas12a Gene-edited Autologous Cell Therapy, in Patients with Severe Sickle Cell Disease Treated in the TUBY Trial
Olubunmi Afonja, MD, MBA
Editas Medicine, United States
Vice President, Clinical Development
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