Drugs developed by the pharmaceutical research industry have revolutionized health care. Yet, in recent years there has been a decline in the number of innovative new drugs reaching the market, despite extraordinary advances in the basic and applied science upon which these new developments depend. Why is that?
Panelists at this event will discuss the most potent forces in drug development, including the Food and Drug Administration (FDA), the government agency at the very center of pharmaceutical drug development. The FDA exercises nearly unlimited power over drug research—from the earliest clinical trials to final product approval—and its scientific expertise and regulatory philosophy can determine whether and when dramatic research breakthroughs are translated into cures. But can the agency keep up with new scientific innovations?
This conference will feature remarks by Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, who will discuss FDA oversight of drug development, including the agency’s Critical Path initiative, a program designed to streamline and accelerate innovation. Following Dr. Gottlieb’s presentation, panelists will discuss drug development and the FDA's role from the perspective of an academic researcher, an industry researcher, and a regulatory economist.