Advanced Therapy Medicinal Products (ATMPs) are biological drugs potentially capable to defeat several pathologies considered untreatable, for example exploiting the regenerative potential of stem cells (cell therapies) or acting directly on DNA mutations (gene therapy). Knowing that, appears evident why a large number of companies and shareholders are investing capital in innovative ATMP projects or in the amelioration of the drugs already approved and present on the market.
In order to tackle the enormous increase in cell and gene therapies validation, the U.S. Food and Drug Administration (FDA) is elevating and reorganizing the OTAT (Office of Tissues and Advanced Therapies) to a “super office”, to meet this increasing workload. According to the FDA’s federal register, the structural changes “will improve functional alignment, increase review capabilities, and enhance expertise on new cell and gene therapies”. This new organization will be named OTP (Office of Therapeutic Products).
The OTP “super office” is just the last of the several measures that the US government is organizing, in order to “advance the field and support the next generation of cell and gene therapies“.