While controversy has raged over the Food and Drug Administration’s (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA’s role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied researchers. The celebrated new tools of molecular biology, matched with new thinking about clinical trials and statistical analysis, have opened the door to faster development, testing, and approval of cancer drugs. But moving innovative new cancer drugs from laboratory to bedside has taken longer than almost anyone expected, especially for such dramatic innovations as the harnessing of the immune system to fight cancer.

At this conference, experts from academia, the National Institutes of Health, and the pharmaceutical research industry will be joined by current and former FDA officials, including former commissioners David Kessler and Mark B. McClellan. Participants will address some of the thorniest issues in cancer drug development, including clinical trial design, statistical analysis of trial results, and the feedback from FDA decisions to the drug development process.
 
This event is cosponsored by AEI and the University of Chicago Law School.