Quantitative Medicine CoE Progress Update

In the 16 months since its founding, the CDER Quantitative Medicine Center of Excellence (QM CoE) says it has achieved “significant accomplishments” in three strategic areas — enterprise planning and coordination, applied regulatory science, and education and ecosystem development. A QM CoE Progress and Priorities Update says the Center of Excellence is a “cooperative, coordinating body that drives innovation and fosters integration of quantitative medicine approaches to advance therapeutic medical product development, inform regulatory decision-making, and promote public health.”

QM CoE director Raj Madabushi says that in an era of unprecedented scientific and technological advances that converge data, analytics, and medicine, the CoE approaches are “primed to play a transformative role in advancing medical product development and informing regulatory evaluation.”