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Gene therapy is having its moment. Can the clinical research ecosystem seize it?
May 13, 2024
By: James Riddle
Senior Vice President, Global Review Operations, Advarra
Gene therapy research is booming. Since the U.S. Food and Drug Administration (FDA) issued its first approval for a gene therapy in 2017,1 oncology researchers have been breaking barriers in gene therapy trials, followed by an explosion in mRNA research during the COVID pandemic. Today, this trailblazing science is providing new ways to approach rare diseases and new hope when other investigational interventions have failed. In fact, the majority2 of approved gene therapies are for rare diseases—14 are currently in Phase III trials for 10 rare diseases and 45 gene therapies are in early stages of development to treat 30 rare diseases. “We see great potential for gene therapies,” said Leslie Johnston, senior vice president of biotech delivery for Parexel. “As more products are approved, it will gain traction and more companies will look to expand their therapies into other therapeutic indications. This progress presents tremendous potential to change more patients’ lives across many different diseases.” This could be gene therapy’s moment. But to fully seize it, the industry must clear some complex hurdles. Gene therapies pose several unique challenges for clinical research, including ethical and safety considerations, regulatory hurdles, precarious logistics, and potentially staggering costs. These challenges may already be having ramifications: New U.S. patients treated with gene therapies approved or in development are expected to fall by one-third from 2025 to 2034.3 The key to clearing these hurdles? Cooperation between sponsors, sites, regulators, patients, and other stakeholders is essential to expediting the advancement of life-saving gene therapies.
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