Codified, Readily Available Informed Consent Gives One Pharmaceutical Company an Estimated $1b First-To-Market Advantage

One year into pivotal trials in the development of a Hepatitis C virus (HCV) drug and, a large pharmaceutical company had a competitor which was three months ahead in their development. Research that came to the attention of the U.S. Food and Drug Administration (FDA) revealed an increased response to HCV treatment by patients possessing a specific IL28b genotype. The robust informatics and proactive management of consent gave the company the ability to leap-frog the competition and gain the coveted first-to-market designation for this new class of treatment.