Almost 40 years ago, pediatrician Harry Shirkey called children’s drugs the “therapeutic orphan” of the industry, and unfortunately that still holds true, says Stephen Spielberg, a pediatrician and 30-year veteran of the pediatric drug-development industry. As a rule of thumb, 80 percent of medications for children are not adequately tested. Why? Even after Clinton-era legislation to encourage more testing of drugs in pediatric patients, there is still a shortage of research. The trials are difficult to run, with poor returns on investment for industry. Outside of antibiotics and asthma meds, which are a large part of the kids’ market, the dosing of pediatric drugs remains mostly a guessing game. IPI Launched That’s why the Boston-area non-profit Institute for Pediatric Innovation was launched in 2006. And that’s why Spielberg just signed on to head up the institute’s five-year pediatric pharmaceutical reformulation program: to get to work doing the research that industry hasn’t…more...