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John Jenkins, former Director of the FDA's Office of New Drugs, discusses approvals standards, breakthrough therapy designation and regulatory science hurdles.
This article analyses the huge volume of clinical trial activity for immune checkpoint inhibitors, and discusses the development of the market and strategic trends for immuno-oncology therapies in general.
Two PD-1 directed checkpoint inhibitors have recently been approved for squamous cell carcinoma of the head and neck (SCCHN). Further checkpoint inhibitors, as well as other molecularly targeted agents and cytokine-based immunotherapies, are currently in the late-stage pipeline and are poised to change the treatment paradigm for SCCHN.
Many organizations are attempting to harness emerging digital technologies and the surge in the amount of health-related data to drive advances in the development and use of medicines. Focusing on just a few well-proven and readily available strategies could enable such organizations to quickly realize greater value from data and digital technologies.
