If a physician doses 10 patients with an investigational drug as part of a registrational trial, does that implicitly bias him for or against that product? If a medical professional with an expertise in a rare disease is a co-principal investigator, should that categorically exclude her from an advisory committee – even if she is one of the few global experts in that orphan condition?
Those are the types of questions that advisory committee consultant and 3D Communications Co-Founder Jim DiBiasi thinks the US Food...