Voices: Kuehn

A Nuclear Approach to Preventing Drug Shortages

Amgen embraces the U.S. Navy’s safety philosophy to fight shortage-causing quality excursions

By Steven E. Kuehn

For those not familiar, even at the dawn of the nuclear power era, it was well understood that in all operations having to do with generating power via nuclear fission, safety was paramount. After all, it was Fermi’s intention to safely control the reaction to benefit mankind. As early as 1946, the U.S. began exploring ways to harness the energy and apply it to naval propulsion, an effort led by Hyman G. Rickover, an enigmatic character who essentially created the U.S. Nuclear Navy. Rickover is widely credited with fostering a safety culture in the Navy that continues to maintain a record of zero reactor accidents. Known as “Defense-in-Depth,” to the Navy and the commercial nuclear power industry, the philosophy has served the Navy well for decades and is now being called on to do the same for one of the most prominent biopharmaceutical companies in the U.S., in its efforts to halt drug-shortage causing quality excursions. According to Madhu Balachandran, Amgen’s Sr. VP, preventing critical drug shortages is one of the Pharma industry’s strongest imperatives.

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