Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills
At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.
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Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.
Patrizia Cavazzoni, CDER's new deputy director for operations, has safety surveillance background and wants to see FDA continue to grow its capabilities.
Panel of experts stresses need to move toward innovative approaches for rare disease drug development such as Bayesian methods, but this would require a paradigm shift in US FDA's regulatory structure.