Biomarkers in clinical trials of Alzheimer Disease (AD): What is expected from regulatory agencies?

Abstract

Biomarkers are key for the different phases of drug development in Alzheimer Disease and in other fields. Traditionally the process of biomarker qualification has been slow, mostly exclusively academic. Regulators were mostly passive spectators. The Pharmaceutical innovation crisis of the end of XX century prompted the regulatory agencies and the governments from both sides of the Atlantic to initiate a number of programs to foster renovation, creativity and new paradigms. This created the opportunity for regulators to move from a passive position to a more active role, as facilitators. However, it is becoming apparent that there is room for even more central roles for regulators in the interactive consortia that are now in place. It is also becoming apparent that regulatory agencies are expected to become highly specialized hubs holding expert “know-how” not easily available elsewhere.