From petri dish to patient:biotech's formidable obstacle course

Moving biotech research from the lab to patients is often harder than the science itself, and investors want to know exactly where a company sits in that process. The article describes the long path from discovery to regulatory approval: laboratory work, pre-clinical testing, human trials, manufacturing, regulators, intellectual property, and years of proving value to doctors and patients. It notes that evidence has to progressively replace promise, and biology can behave very differently in humans than in lab dishes or animal models. As an example, NeuroScientific Biopharmaceuticals said it is meeting the FDA at the end of August to review its StemSmart plan for a Crohn’s disease Investigational New Drug submission scheduled for the end of this year.