Bruce Montgomery remembers the moment he came faceto-face with a quality-of-life issue. It was the summer of 2004, and he had traveled to Maryland to meet with staffers at the Food and Drug Administration to discuss an inhaled antibiotic, which his company, Corus Pharma, was testing for cystic fibrosis. He was optimistic that the medication would eventually pass muster with the agency, given that Phase II results looked promising.
Then, officials threw him a curveball. "They looked at me and specifically said they wanted a questionnaire showing patient-reported outcomes for respiratory symptoms for Phase III," says Montgomery, who founded Corus in 2001 and later sold it to Gilead Sciences, the Foster City, Calif., biotech where he now works as senior vice president and head of respiratory therapeutics. "I took a deep breath and said, 'okay, let's see if this could be done.'"
Although ...
