As Medicine Evolves, So Too Must Those Who Assure Its Quality

The past few years have illustrated the startling speed with which medicine can evolve. Since 2018, the US Food & Drug Administration (FDA) has approved first-of-their-kind drugs based on RNA, gene therapy, and cancer-killing chimeric antigen receptor (CAR) T-cells and signed off on human trials to explore the clinical use of CRISPR-mediated genome editing. And throughout this process, the US Pharmacopeia (USP) has been working in the background to ensure that quality standards are in place for new medical products reaching the market. “200 years ago, our first monographs were basically recipes: ‘take bark from this tree and boil it for this long and you should get a brown liquid’,” says Michael Levy, Head of Research & Innovation (R&I) at USP. “Obviously we've evolved tremendously since then, but it’s just a continuation of what we’ve always done—we’re just doubling down on it.”

Regular revisions to quality standards to accommodate advances in knowledge and changes in medical practice were built into the USP process by its founders. Today, to ensure its standards stay current, USP also works to stay ahead of the rapidly changing technology curve. Well before a cutting-edge medicine reaches the market, the underlying tools and techniques are already percolating up into the scientific literature and presentations at international conferences. USP combs through this early-stage work and projects which prospects seem most likely to impact the quality of therapeutics within the next decade or so. “We ask what’s on the horizon, what are the quality issues potentially associated with that trend or technology, and how does USP need to respond,” says Levy.  USP then explores some of these technologies, working through a typical research approach with preliminary proof-of-concept work potentially followed by longer-term “incubation projects” conducted by subject-matter experts.

The full article from Scientific American can be viewed at this link.