conversations To Your Health The Challenge: In the early 2000s, a 50 percent failure rate for mental-health-drug trials meant the Food and Drug Administration approved few new treatments for psychiatric diseases, says Amy Fershko Ellis, ’80, who cofounded MedAvante in 2002 to analyze how the pharmaceutical industry tested psychiatric drugs. Her team found the root cause of trial failure was measurement variability and investigator bias in subjective assessments of trial participants. MedAvante created a holistic methodology to improve testing, but the company encountered industry resistance as outsiders looking to change the way clinical trials had long been conducted. The Strategy: Ellis applied universal principles to product development. Because drug trials are conducted in various parts of the country and around the world, companies pay investigators to find, evaluate, and enroll patients. But differences between investigators result in unreliable outcomes. MedAvante, however, proposed a way to control and centralize the evaluation process, using the internet to connect remote clinicians to patients to ask the same questions in the same way and characterize patient responses identically. MedAvante also digitized the process and made it cloud based, so researchers would have instant results. To build credibility, MedAvante enlisted key medical and scientific leaders who believed in their strategy and concept—mostly academics who didn’t have an economic bias. In 2005, MedAvante’s first two trials involved drugs that had previously failed. The new methodology showed significant results demonstrating the drugs worked, and the treatments were approved. Even with those results, industry skepticism of MedAvante’s nontraditional approach meant slow methodology adoption. But by 2009 the psychiatry industry embraced the system, and MedAvante dropped the 50 percent trial failure rate to the low teens. In 2014, MedAvante expanded the platform for use in all medical drug trials, using new technology to enhance data quality for drug developers. New services were quickly adopted beyond psychiatry, especially in studies of Alzheimer’s disease, where the company now holds a leadership position. “We benefited from the halo we had from our success,” Ellis said. The Takeaway: A great strategy can work in all sectors, even if implemented by industry outsiders. If the strategy and results are sound, don’t be discouraged by naysayers.