So you want to make a personalized drug?

Abstract

In 2002, Lauren Black had grown frustrated with her job. She had been working at the US Food and Drug Administration as a reviewer for just over a decade. “I saw too many resources wasted,” she says. Drug companies were submitting a surplus of animal studies along with excessive or simply irrelevant data. “I thought it was time to go out and work further upstream.” So she took a job at Charles River Laboratories, a contract research organization (CRO) that drug companies turn to for animal models, toxicology studies, and more. In her 17 years there, Black has helped streamline research and package it into digestible forms for FDA review. And today, she’s taking that thinning to its most extreme form by leading the company’s role in developing N-of-1 therapies—drugs that are custom designed for a single individual’s exceedingly rare genetic mutation. Although Charles River has been involved with only