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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

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

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)

Scott  Burian, PhD

To be determined

Scott Burian, PhD

Rho, Inc., United States

Senior Scientist

Emily  Walsh, PhD, PMP

IND Enablement for First in Human Testing for Gene Therapy

Emily Walsh, PhD, PMP

Tremont Therapeutics Consulting, United States

Principal

Daniel  Kavanagh, PhD, RAC

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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