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Thursday, June 18 • 5:00pm - 6:00pm
#533 OD: ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation

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Component Type: Session
Level: Intermediate

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 Objectives

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.


Daniel Kavanagh, PhD, RAC


To be determined
Scott Burian, PhD

IND Enablement for First in Human Testing for Gene Therapy
Emily Walsh, PhD, PMP

Preparing for IRB and IBC Reviews of Cell and Gene Therapy Research
Daniel Kavanagh, PhD, RAC

avatar for Daniel Kavanagh

Daniel Kavanagh

Senior Scientific Advisor, Gene Therapy, WCG
Dr. Kavanagh is Senior Scientific Advisor, Gene Therapy at WIRB-Copernicus Group (WCG). Prior to joining WCG, he was Assistant Professor of Medicine and Institutional Biosafety Committee Vice Chair at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital... Read More →
avatar for Emily Walsh

Emily Walsh

Principal, Tremont Therapeutics Consulting
Emily Walsh is an executive and scientist with 15 years of experience in biopharmaceutical development. Over more than a decade, she has held program leadership and management roles with increasing responsibility across a range of technologies and disease areas. From small molecules... Read More →

Scott Burian

Senior Scientist, Rho, Inc.
Dr. Burian is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC). Prior to joining Rho in early 2016, he served most recently as a Director, Regulatory Affairs CMC... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session