Why Philip Sager thinks better preclinical tools can spur drug development
A two-year-old FDA initiative is progressing toward its goal of replacing clinical QT studies with preclinical assays that do a better job at predicting proarrhythmia side effects. The question is what impact replacing QT will have on early drug development.
To discuss the issue, BioCentury sat down with Philip Sager, a cardiologist and consulting professor of medicine at Stanford University School of Medicine. He also sits on FDA's Cardiovascular and Renal Drugs Advisory Committee and is a consultant for Sager Consulting Experts Inc.
Sager thinks there could be a two-pronged effect from the effort that was started by FDA's Norman Stockbridge, who organized a workshop in 2013 along with Sager, the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) and the Cardiac Safety Research Consortium (CSRC).
First, he thinks better tools to evaluate cardiovascular safety could prevent early stage compounds from being unnecessarily discontinued, while still weeding out molecules that