Viewpoints

The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.

Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.

We, the people who make drugs, are extraordinarily good at what we do.

The role of micro-biological testing in real-time release is too important to ignore.

It's what's on the outside that counts, too.

When it comes to ethics, the adage "hindsight is 20/20" is especially applicable. Countless medical and psychological experiments-such as the 1932 Tuskegee syphilis study or Zimbardo's 1972 Stanford mock-prison experiment-were conducted in the name of science and are now plainly recognized as enormous violations of ethical and human rights.

Industry will be challenged to embrace new methods of supply chain collaboration.

The closing presentation was perfectly pitched to bring a lump to our throats and have us cheering for fast-track drug development. I and 30 other journalists had spent the day touring a Big Pharma plant, and now sat shoulder to shoulder in a warm conference room, awaiting the final speaker.

Ninety million people live in California, Texas, New York, and Florida. Imagine that, sometime tonight, an unnameable catastrophe carries off everyone in those states over the age of 14. When the sun comes up tomorrow, only the children remain. Eighteen million children, left to care for one another or fend for themselves.

The production staff was sure the lab couldn't test their way out of a paper bag.

Poor support of drug- and process-development training programs will affect industry's future growth.

Makers of injectable drugs can increase their market share and stay competitive by devising a product life-cycle management strategy.

We really knew what we were doing-until we opened the column for a routine repacking.

Years of concentrating its political support on one side of the political spectrum may have eroded the industry's ties to the new majority.

The refusal to sell was motivated by a desire to maximize GSK's profits, and GSK had not shown that not having these profits would prejudice consumers by restricting GSK's R&D.

Yet again, FDA's ability to regulate drugs is under fire. At the core of this latest round of scrutiny is whether the agency has the resources to properly control the safety of new nanotech-based drug products.

Here's to all the difficult, out-of-touch, and irresponsible coworkers that make our workplace interesting.

The reason for reading the report is to inoculate ourselves against error.

Branded pharmaceutical companies have long been immune to the cost pressures faced in other industries. With robust research and development pipelines, long periods of patent protection to ensure continued high margins, and a regulatory environment that has virtually eliminated the threat of overseas competition, pharmaceutical companies have traditionally considered spend management an afterthought. Recent changes in the pharmaceutical industry, however, have begun to erode Big Pharma's once-imperious position.

Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.

Much is riding on the market success or failure of Pfizer's Exubera inhalable insulin.

Getting "swamped at work" takes on an entirely new meaning for these GMP Agents.

Teamwork, communication, and trust are as important as the technology.

I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.

No matter how much we scamper about, the sheep just won't go where we want them to.

Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.

Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.

With a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team

Street-corner oratory may seem like a dying art, but if there's one place you can still find people literally up on their soapboxes, spewing views on religion, politics, or ethics, it's New York City. And, if there's one time I religiously follow the advice of my native New Yorker father ("Look down while you're walking and don't make eye contact with people you pass"), it's when I see these soapbox stars and the crowds surrounding them.

Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.