In pharmaceuticals as in most manufacturing industries, the plant floor has never been the sexiest place to work. Manufacturing--all those people, processes, and systems needed to translate a new drug discovery into societal benefit and business profit — is often treated as a necessary, black-box step between the more satisfying Eureka! of research and ka-ching! of commercialization.
But like their accounting brethren, who once toiled in relative obscurity only to have the bright light of scandal shine upon them, the engineering and operations professionals who usher new medicines from discovery through production face a litany of increasingly visible demands.
Manufacturing has corporate management's attention like never before. Over the past several months, a rash of new drug delays and multi-million dollar settlements arising from FDA inspections of manufacturing facilities have made management realize that plant floor happenings can impact profitability and the all-important stock price.
All this in a market beset by larger issues that will only increase the pressure on manufacturing. New drug development costs continue to rise, as do the number of competitive drugs. Indeed, all indications point to a future filled with far more specialty medicines and fewer high-volume blockbusters. The managed care lobby, societal expectations, more limited patent protection and a burgeoning generic and over-the-counter market all are squeezing margins. And, simultaneously, Sept. 11 and last year's anthrax attacks have moved security concerns to the fore.
So what's an already busy drug maker to do first? Well, Pharmaceutical Manufacturing magazine, the first issue of which you hold in your hands, was launched to help. Our mission is to serve the information needs of you — the engineering and operations professional whose job it is to design, build and run the pharmaceutical industry's manufacturing assets. That means name-brand drug companies, contract manufacturers, engineering firms and other service providers.
Of course, the manufacturing technology itself is a huge part of the equation. We'll keep you informed of the latest developments in both upstream, process-oriented manufacturing technology as well as in downstream preparation and packaging techniques.
Further, we believe that the pharmaceutical manufacturer of tomorrow must increasingly rely on automation and information systems technology to ensure quality and to intelligently manage all data related to the complete life cycle of its products--the people, the processes, the equipment, as well as genealogy of the products themselves.
In the pages of Pharmaceutical Manufacturing you'll find the information and advice you need to begin to make that vision a reality. Today, a typical pharmaceutical-manufacturing site might use some 70 disparate systems — many of them paper-based — for tracking and managing the data required to satisfy the FDA's regulatory demands. Clearly, this approach won't cut it in the future. And while meeting the FDA's expectations is certainly a cost-of-doing-business, new ways of doing things will be essential to improving manufacturing efficiency, boosting product quality and bringing new drugs to market more quickly in an increasingly competitive global market.
I encourage you to give the rest of the magazine a read. And if you find something useful, sign up for your subscription--free if you meet our circulation qualification standards.
Let me know what you think, as well. This is your magazine and we want it to meet your needs.
