Preparing for Multisite Gene Therapy Studies

image iconDuration: 1 hour

The fast and dramatic growth in the field of gene therapy is unprecedented, as the US FDA and regulatory agencies of several other countries have begun issuing approvals for licensed gene therapy products. The regulatory environment has also evolved to accommodate the boom in growth.

Clinical trials involving human gene transfer are beginning to spike, not just at large academic medical centers but also at smaller clinical research sites. The field is growing particularly fast in oncology, infectious diseases, and diseases caused by a single defective gene. For human gene transfer studies that receive federal funds or take place at sites receiving federal funds, federal requirements call for review by both an IRB and an IBC prior to registering with the NIH.

In this webinar, Daniel Eisenman, Director of Biosafety Services for Advarra, will discuss the basics of how to prepare gene therapy research and the benefits of centralized review for multisite gene therapy studies. He will also explain the IBC’s role in ensuring research is conducted safely and responsibly.

Learning Objectives

Following this free webinar, attendees will be able to:
  • Define the federal requirements and oversight structure governing gene therapy research involving recombinant DNA and synthetic nucleic acid technology
  • Explain the role and functions of the IBC, including types of studies which may require IBC review
  • Describe how to prepare for IBC review
  • Identify the benefits of centralized review of multisite gene therapy studies through externally administered IBCs

Presented By
Dan Eisenman.png

Daniel Eisenman

PhD, RBP, SM (NRCM), CBSP
Director of Biosafety Services
Advarra

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