Rethinking Information Asymmetries: Regulating Medical Therapies using Genomic Alteration at the FDA
December 7, 11:40 am – 12:30 pm PST
This study examines the regulatory processes surrounding approval for human clinical trials of therapies using genomic modification (e.g., CRISPR) and finds, according to those with relevant IND experience, that regulators are sufficiently up to speed in the science required to test the safety and effectiveness of such therapies. These findings challenge the common assumption that regulators lag the private sector when it comes to technical expertise related to rapidly emerging technologies. Drawing from the literature on bureaucratic agencies, the study examines why we might find substantial agency expertise in areas of rapid technological innovation.
Dr. Ann C. Keller is Associate Professor of Health Politics and Policy at the UC Berkeley School of Public Health and studies the politics of science and expertise in public policy, focusing on environmental, health and technological innovation. Recent publications focus on how politics shapes aspects of the implementation of the Affordable Care Act. Her most recent NSF grant, from its Science of Science and Innovation Policy, focuses on public sector responses to CRISPR/Cas-9 and automated vehicle innovations. She is also researching the effects of hyperpolarization on executive branch agency capacity and studies the management challenges involved in responding to infectious disease outbreaks.
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