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ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation
Session Chair(s)
Daniel Kavanagh, PhD, RAC
Senior Scientific Advisor, Gene Therapy, Vaccines & Biologics
WCG, United States
This session will review special challenges for sponsors and investigators preparing for research involving gene therapy, CAR-T cells, oncolytic viruses, and other recombinant or synthetic nucleic acid products, from IND preparation to first-patient-in.
Learning Objective : Discuss unique considerations for CMC of investigational gene transfer products for phase 1; Explain the role of the Institutional Review Boards (IRBs), NIH guidelines, and institutional biosafety committees in human gene transfer research; Describe common pitfalls preventing efficient site initiation for research involving recombinant and synthetic nucleic acids.
Speaker(s)
To be determined
Scott Burian, PhD
Rho, Inc., United States
Senior Scientist
IND Enablement for First in Human Testing for Gene Therapy
Emily Walsh, PhD, PMP
Tremont Therapeutics Consulting, United States
Principal
Preparing for IRB and IBC Reviews of Cell and Gene Therapy Research
Daniel Kavanagh, PhD, RAC
WCG, United States
Senior Scientific Advisor, Gene Therapy, Vaccines & Biologics
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