Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?

Sunday, September 10, 2023

8:00 AM - 9:30 AM PT

Location:Grand Ballroom E-K

CE: 1.5

Chair & Faculty(s)

Christopher Doyle, PhD (he/him/his)

Director, IBC Svcs
WCG Clinical Svcs
James Riddle, MCSE, CIP, CPIA, CRQM

VP Research Services & Strategic Consulting
Advarra

The target audience for this Plenary Session includes PharmD, MD and PhD scientists with an interest in gene therapy research.

Following the completion of this activity, the learner will be able to:

Provide examples and indications for commonly used genetically-engineered therapies;
Describe the unique risks and handling precautions associated with emerging genetically-engineered therapies;
Define the basic regulations and guidelines governing institutional biosafety committees (IBCs) and institutional review boards (IRBs) in relation to clinical gene therapy research;
Explain the role of the IBC and how their oversight is different than that of the IRB;
Outline key takeaways to prepare your research site to participate in this growing field of research.

Introductions
Chair & Faculty: Myong-Jin Kim, PharmD – US Food & Drug Administration
Scientific Perspective
Faculty: Christopher R. Doyle, PhD (he/him/his) – WCG Clinical Svcs
Regulatory Perspective
Faculty: James Riddle, MCSE, CIP, CPIA, CRQM – Advarra
Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation