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Continuing the Conversation: What’s New in Gene Therapy and Gene Editing
Session Chair(s)
Philip (P.J.) Brooks, PhD
Deputy Director, Division of Rare Diseases Research Innovation
National Center for Advancing Translational Sciences (NCATS), NIH, United States
This session will cover specific considerations for the nonclinical evaluation of GTP from a US regulatory perspective. In addition, we will present specific case studies to demonstrate the unique variability in nonclinical testing strategies for GTP.
Learning Objective : Describe the nonclinical safety requirements for gene therapy products (GTP)(oncolytic virus, CRISPR/Cas9, therapeutic vaccine); Discuss specific considerations for the nonclinical evaluation of GTP from a US regulatory perspective; Identify specific case studies to demonstrate the unique variability in nonclinical testing strategies for unique GTP.
Speaker(s)
Nonclinical Safety Evaluation Strategies Enabling IND and Marketing for Gene Therapy Products
Zeck Huang, MD, PhD
Topalliance Bioscience, United States
Director
Immunogenicity Issues Related to CRISPR Cas-Mediated Gene Editing
Zuben Erach Sauna, PhD, MS
FDA, United States
Principal Investigator, OTAT, CBER