From the Editor

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

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

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.

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

While e-mail is quick and convenient, it's too easy to hide behind and, ultimately, faceless.

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

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.

It's been a while since I last wrote my last editor's comment - a combination, during the last few months, of attending a variety of industry events (as the conference and exhibition season peaked before the summer) and being on holiday. I apologize for the poor excuses, but it's certainly better than saying the dog ate my homework.

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.

Returnees and home-grown talent aim to make China a pharmaceutical powerhouse.

Industry must look at manufacturing as a competitive advantage, not just a way to get product out the door.

From RFID and pedigrees to PAT and process understanding, industry professionals are eying the growing gap between ambitious high-level guidance and current practice, and wondering how they can bridge this new space and keep in compliance with the untested rules.

We can learn a lot about today's regulatory environment as a whole if we take it all in.

Does "personalized medicine" mean personalized treatment or personalized molecules, custom made for a patient's specific biology?

At this year's BIO conference, US Health and Human Services Secretary Mike Leavitt predicted that over the coming decade, "Medicine will be transformed from an instinctive art of alleviating symptoms to a science of personalized healthcare." Is industry ready?

From the most frenetic conference season in recent memory, trying to distill perspective from mental snapshots of Interphex, Wisconsin, and BIO 2006.

Hubert J.P. Schoemaker and William T. McCormick. Perhaps we could have not a special day, but just a moment to remember what we owe and who we we owe it to.

Despite worries that industry is slow to adopt anticounterfeiting technologies, the 2006 Interphex program is rife with new methods for securing the supply chain.

FDA's 2007 budget request funds homeland security and pandemic preparedness by reducing support for the agency’s core mission.

The outcomes of complex chains of reactions are hard to predict. Hindsight being 20–20, I can tell you that implementing the prohibition of alcohol in the 1920s-which was intended to reduce corruption and social problems, but actually lead to a rise in organized crime-was a bad idea.

FDA is opening the door to continuous learning in process development.

I rarely talk science on the weekends. I spend a good deal of that free time with friends from college performance groups. The conversation centers more on choreography and piano concerti than on CGMPs and chemical reactions. So it always throws me for a loop when these theater and music buffs drop pharmaceutical news into casual conversation.

Is the recent round of Big Pharma plant closings a sign of regrowth?

This year's fall conference season clearly shows that the new, systematic approach to process planning and product quality is permeating the industry's thinking—if not yet its daily practice.

First, a confession. Yes, the four sleep-deprived editors hunched behind glowing laptops in the Opryland Resort's Cyber Café last month were indeed from this publication. Normally, our mumbled conversations about punctuation and grammar take place before 11:00 pm—and under slightly lower systemic levels of caffeine, sugar, and sushi.

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

As industry moves to real-time feedback control, even conventional syntheses will increasingly resemble living systems.

Confronted by a challenge as vast as Hurricane Katrina, we reach for military organizations for aid and military language for description.