Cutting Through the "Gray Area": An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research.

The advent of clustered regularly interspaced short palindromic repeats (CRISPR) technology has quickly ushered in a new era of gene editing and offered exciting potential for the development of biomedical products. While the breadth of applications for CRISPR encompasses nearly the entire field of medical science, its utilization to produce next-generation CAR T cells stands to benefit most substantially in the short-term. These novel therapeutics are now beginning to enter the clinical trial phase of the numerous approval pipelines, but does the existing regulatory framework have the capability to adequately review and approve the initiation of these new age research endeavors in the clinical setting? This analysis will illuminate the similarity and differences between CRISPR developed interventions and existing techniques used to produce biomedical products from a regulatory perspective in the United States. Further, the "gray area" surrounding CRISPR regulatory oversight will be explored and recommendations will be made to facilitate the elimination of inconsistencies that currently exist in the assessment of this work prior to the initiation of associated clinical trials.