Once upon a time, I worked as a communications consultant for a major pharmaceutical, helping to educate physicians on the company’s drugs, recent trial results, changes in prescribing information, so forth and so on. I met countless physicians paid by the company as speakers and advisors—many of them nice people and consummate professionals, others primadonnas and pompous jerks.

Earlier this summer, we wrote about a talk by FDA CDER’s George Smith, the lead for the Agency’s 21 CFR Part 11 working group, regarding the “add on” surveillance of computer systems that FDA is now performing during the course of its regular site inspections. The point is to gather information about how Part 11 is being used within the industry.

We've just published, in print and online, our latest cover story: “The Good Fight: The Plight of Pharma’s Middle Managers.” It’s a rich, timely topic, given the fact that much of the finger pointing regarding the industry's problems is aimed at mid-level professionals. Or they are implicitly faulted, as upper management absolves itself of responsibility.

A news item in Jim Edward’s blog brought heart-warming news of Pfizer’s decision to reduce medical benefits to retirees. The move, which the company was reportedly “pleased to announce” to its retiring employees, will leave retirees dependent on Medicare and their own savings, Edwards wrote, and has spurred a letter-writing campaign. More from the source.

1. We studied that 10 years ago, why are you doing it again?
2. Where did Joe retire to? Can we find him?
3. Where can we find that study?
4. I know it is in the database, but I haven’t been able to bring it up.
5. Why does our filing not match our master batch record?
6. Where can we find the information to answer the FDA inspector’s question?
7. Can we send out an email asking to see if anyone knows about this?

The above questions are courtesy of John McShane, head of Global Quality System Biologics for Roche/Genentech.

Change management has become an important and accepted aspect of corporate success in recent years. Companies are beginning to understand that anticipating major change—whether it be in terms of products, processes, or people—and having a systematic methodology for handling it makes a lot of sense—to the stability of the organization and contentment of workers.

Over the past several years, the ICH Quality Implementation Working Group has helped to develop and spearhead the adoption of ICH Q8, Q9, and Q10, guidelines which spell out the Quality by Design principles that (slowly but surely) drug manufacturers worldwide are taking to heart.

Earlier this year, Milwaukee Journal Sentinel reporters Raquel Rutledge and Rick Barrett conducted a four-month investigation into manufacturing issues at the Hartland, Wisconsin facility of H&P Industries, which (until a recent consent decree) produced hospital wipes, cough syrups, ointments, creams, and other health products.

Middle managers in the life sciences are underappreciated and underrated in their significance, and yet they're often the first individuals to be blamed for operational issues or to be laid off during restructurings.

I’ve been attending BIO for about five years now, but the 2011 conference in Washington, D.C. last week was more subdued than I’d seen it. There was no sign of Bono, Elton John, movie stars or NBA players on the show floor, no media circus of the kind generated by Arnold Schwarzenegger a few years ago.