Modern Drug Development: From Molecule to Market
The Treacherous Journey from Discovery to Patient
Abstract
Under the cover of darkness, a tiny loggerhead turtle breaks free from its shell, joining dozens of siblings in a desperate race across the beach. Born on the same shoreline where their mother once emerged, these hatchlings face overwhelming odds. Only one in a thousand will survive to adulthood. They must navigate past ghost crabs and seabirds, find their way to the ocean through disorienting artificial lights, and then survive decades of predators, plastic pollution, fishing nets, and changing ocean conditions before potentially returning to this same beach to continue the species.
This ancient ritual of nature—repeated for over 100 million years—bears a striking resemblance to a much newer human endeavor: the development of modern pharmaceuticals. Like these vulnerable hatchlings, most promising drug molecules never reach maturity. Only 1 of 10 preclinical compounds ever enter human trials and a staggering 95% of drug candidates entering human trials fail to achieve FDA approval1. Those that survive the gauntlet of discovery, preclinical testing, three phases of clinical trials, regulatory review, manufacturing scale-up, and market launch do so against tremendous odds.
