Article | August 9, 2021

Why Institutions Should Consider An Externally Administered IBC

Source: Advarra

By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP Executive Director, Biosafety Services

iStock-178131492-lab-research-beaker

Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine. In January of 2019, then-Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Peter Marks, Director of the FDA Center for Biologics Evaluation and Research (CBER), announced new policies to advance gene therapy research and described the current state of gene therapy as “…similar to the period marking an acceleration in the development of antibody drugs in the late 1990s, and the mainstreaming of monoclonal antibodies as the backbone of modern treatment regimens.”

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