As the clinical supply industry evolves, so does its vernacular. Small molecules are making way for large ones, resulting in genetic therapies. We no longer work in ambient conditions; today, controlled room temperature best describes the handling process. Even the term sponsor company itself evolved from the fact that companies other than R&D pharmaceuticals are running trials.
One drawback to this evolution is language’s habit of lingering beyond its logical lifespan. If you still “dial” someone’s number but haven’t touched a rotary phone in decades, or “roll up” the automatic windows in your car, you understand the habit of holding onto sayings even after they stop making literal sense. In the clinical packaging industry, a memorable example is IVRS, short for interactive voice response systems. When IVRS systems began giving way to voiceless interactive response technology in the late nineties, “IVRS” hung on, serving as the default terminology for years after voice features had faded.
Today, the term CMO is the primary offender on the nomenclature front. If the exact definition of CMO leaves you scratching your head, it’s proof positive of the problem. Today, we still – astonishingly – use “contract manufacturing organization” to describe the drug substance manufacturer, the drug product manufacturer, the fill/finish vendor, and clinical packaging groups that do not often “manufacture” a single thing.
The misnomer traces back a few decades, to when pharmaceutical companies handled packaging, labeling, and distribution in house. Executed in close proximity to manufacturing and production (by companies best known for manufacturing and production), packaging, labeling, and distribution were lumped under the “manufacturing” umbrella. In time, pharmaceutical companies restructured and began outsourcing manufacturing, packaging, labeling, and distribution to vendors designed specifically for these highly regulated services. Strangely and erroneously, the “CMO” categorization went along with them.
This ambiguity strikes at the very heart of how different stages of drug development are managed. CMC monitoring – the acronym standing, of course, for Chemistry, Manufacturing and Controls – selects, qualifies, and oversees vendors that manage the drug substance manufacturers, the drug product manufacturers, and the fill/finish stages of drug development. These are the CMC vendors and their areas of concern. But it is the clinical supply managers that select, and actually work with and manage, the clinical packaging vendors. For these reasons and more, Xerimis and others in the industry are describing packaging specialists with a name that describes us accurately: Contract packaging organizations (CPOs). By identifying as a CPO rather than a CMO, we distinguish ourselves from companies that don’t always offer our caliber of experience, expertise, and specialization.
This naming breakout is in step with the clinical supply industry’s commitment to identifying people and services by the service they truly provide. CRO, CMO, and IRT are other relatable examples of clear-cut nomenclature within a field that can’t afford confusion.