By Wayne Koberstein, executive editor
Do you have a good mental picture of the life sciences supply chain? Such a common term, widely repeated without reservation — no wonder few people stop and think before they say it. A universal principle may apply: the more used, the less understood the term.
It would be the most natural thing in the world if no one working in the supply chain could envision it in totality. At one end are specialized functions such as compound formulation and analysis; at the other, mass production and distribution. In between lies a complex line of discreet goods and services that all do their part to move products to the market. At any given point, peoples’ awareness may extend a few links back or forward but never encompass a detailed knowledge of the entire chain. Why should it? Perhaps, because the knowledge is becoming valuable.
Suddenly, it seems, CEOs are discovering the virtues of quality and efficiency in the supply chain, issues they once routinely left to their engineers and heads of manufacturing. The cause goes by various names: lack of therapeutic innovation, poor R&D productivity, and patent loss, to name a few. The chief executives’ newfound concern for supply issues reflects a corporate-level realization that such issues, however mundane they once may have seemed, carry strategic weight.
From a long-term perspective — and if you’ve lived long enough you can’t ignore it — the change has been dramatic but not linear. In fact, it more resembles a circle. There were days when every pharma company was a little world unto itself, typically dedicated to a narrow product line and with administration, science, and factory buildings all on a single, walkable campus, following the old European model. Some chief execs would take me on personal tours through the plant floor, proudly pointing out new automated packaging lines with in-line QCs such as close-in video monitoring of pills and vials. But when most companies merged into global conglomerates with diverse product portfolios, the close connection of corporate management to its supply chains dissipated.
Several key phenomena have encouraged the contemporary return to supplychain consciousness by top execs — biotechnology, drug delivery, and generics. Biotech companies revived the campus model, keeping production and supply proximate to management, and the first fundamental goal of biotech was creating new ways of producing medicines. Drug delivery and its near cousin specialty pharma also demand an emphasis on manufacturing and supply. And, perhaps also in related fashion, generics are competing ever more on the basis of quality, pedigree, and supply chain efficiency.
The growth in the use of CMOs has also fueled a return to supply chain issues for top pharma-company management. Shared regulatory accountability necessitates collaboration between sponsors and contractors. Because this collaboration is spreading, if you want to produce the best possible results at the end of the chain, you must get every link to add strength to every other. My perception is that demand will grow for people who can combine intimate knowledge of each link with an integrated understanding of the entire chain.
In a still broader context, chief executives’ current concern for the supply chain stems from a shift toward premarket preoccupations. Don DeGolyer, CEO of Sandoz US, says his purview is now 60% precommercial, 30% commercial, and 10% political. (See “Rediscovering Generics — Sandoz Vows To Serve Patients First,” September 2012.) That is as it should be for every exec, small-company, largecompany, or any company. Innovation is a universe of breakthroughs, from the moment of discovery to each moment of translation, right on through to application in the real world of medicine.
TURNING AWARENESS INTO ACTION
Supply chain competency might make a logical benchmark for innovation — that is, if there were a critical mass of highly supply chain competent companies to form the benchmark. Yet, all the signs I see point to an industry awakening, not to a reconstruction. Except in the aforementioned areas where manufacturing and supply are competitive essentials, the great big old pharmaceutical industry still plows along technologically, well behind many other industries with comparable supply chains.
Now, almost a decade since the FDA issued calls for QbD (quality by design), PAT (process analytical technology), and other upgrades — with a major goal, I should say, of easing the industry’s regulatory burden — you will find only a few examples of companies responding materially. Even among the few such applications out there, most are small pilots or experiments that seem insignificant in the context of a Big Pharma organization. Where some alternative production platforms, such as single-use systems, have seen greater adoption, the emphasis has been on flexibility, small-batch processing, and other exceptional settings. In-line monitoring, a big advancement when I first saw it in the eighties, may still be the most popular upgrade because companies can easily adapt them to legacy systems, thus having their cake and eating it, too. Or so it seems. Companies may be, in fact, significantly under-exploiting the potential of in-line monitoring when applied in wholly new platforms such as continuous flow processing.
There is no shortage of explanations for the glacial progress of supply chain reforms in the industry; they range from defensive or apologist to cynical or resigned. Reluctance to invest, fear of organizational disruption, an “it-ain’t-broke-so-don’t-fix-it” mentality, and so on — all pretty much boiling down to, “We’re comfortable with what we have, and nothing else has made us uncomfortable enough to change it.”
Again, a circle, not a straight line, shapes progress. Companies will be reminded again and again that inefficiency and lack of “modernization” as the standard evolves cannot continue forever — or even much longer. Action must follow awareness, and executives must follow through, even at the displeasure of those down the line who favor the status quo.
The industry cannot go on criticizing regulators for imposing burdens if it is unwilling or unable to implement changes meant to lift those burdens. In other areas, industry may have a legitimate beef with regulatory overkill, but manufacturing and supply — what we know as the supply chain — offers an opportunity for companies to step up to the plate. And not only companies, but also every player who represents a vital link in the chain must answer the clarion call.