A recent Harris opinion poll found that the pharmaceutical industry is now at the bottom of the heap, along with tobacco and big oil, in the public's view.No doubt you've seen this coming. As the bitter debate over drug importation continues, peppered by scandals involving research data and insurance fraud, the image of greedy, inflexible drug companies has taken root. It will be hard to shake.Still, the poll results represent such a seismic shift in public opinion that they've shocked an industry whose products heal, and have consistently increased life expectancy and raised the standard of living. After the news came out, trade organizations and many companies hastily scheduled press conferences, and some firms rolled out new initiatives to improve access to, and reduce prices for, some of their medicines.What those press conferences didn't discuss is the fact that manufacturing operations--long the industry's "stepchild",have the potential to turn the industry's negative image around. As you all know, drug manufacturing remains a wasteful business. The industry is currently operating at two to three sigma quality levels, far short of the predictability and reproducibility demanded in other industries. Turnaround times are long, and waste is assumed. Consider the fact that every new pharmaceutical plant is built with incineration capacity. As one industry expert asks, "Does BMW design car crushing capacity into its facilities for off-spec product?"More drug companies are grappling head on with these issues, and reducing wasteful processes at their facilities. The most successful of these efforts focus on end users' needs and empower workers to improve the manufacturing environment to achieve better results. In this issue, we examine a pilot program at one of Novartis' plants, designed to reduce cycle times to six days. The company has taken some drastic steps familiar to other manufacturing industries, but new to drug manufacturing--it has eliminated front-line supervisors and gone to a product-centered, work-team approach, and are already seeing substantial improvements. The plant's employees are rising to the challenge of constant change, and approaching their jobs with new understanding and vigor.We also look at process analytical technology (PAT), which is becoming a critical tool for reducing costs and improving quality. Elements of the technology have been around for decades, but only now is it gaining acceptance in drug manufacturing. We'll also scan the new tools being used to improve the hand-off between R&D and manufacturing, as more companies focus on customer requirements and quality, and develop a more efficient, collaborative approach to product development.No doubt, there will be much spin doctoring over the next year, as the drug industry responds to the Harris Poll's wake-up call. In the past, the industry's print and television ads have always featured researchers in white coats toiling in the drug discovery laboratory.Now, it's high time that manufacturing professionals get their due. In a few years, I can envision a TV spot showing a drug company's manufacturing team on an average day--troubleshooting an HVAC problem one minute, resolving a "people" conflict on the shop floor the next, then moving on to adjust a mixer, saving a $2-million batch from ruin. Their efforts will bring down the cost of medication, and improve quality. The camera would then pans to end users--senior citizens in Texas Uganda
