Back Bay Life Science Advisors in the Boston Business Journal on Gene Therapy Regulation
Back Bay Life Science Advisors’ Andrew Collard spoke with the Boston Business Journal about the move by the FDA and the National Institutes of Health to reconfigure their approach to gene therapy and gene editing, potentially shortening the regulatory process and leading to cheaper drugs.
In the article, “How a new approach to regulating gene therapy will affect Mass. Biotechs,” reporter Allison DeAngelis writes that this regulatory shift marks a maturation point for the technology and as more companies explore gene therapies, double layers of oversight caused "substantial duplication" in protocol submission and reporting that lengthened the development timeline, leading to more costly drugs.
Back Bay’s Andrew Collard added: "When you only had a couple trials a year being proposed, it made sense to have an expert body and extra layer of oversight. . . but it adds time and complexity to an already labor intensive process."