Category Archive

The following is a list of all entries from the General category.

“Approvable” Removed from the FDA Lexicon

One of my first assignments in the pharmaceutical industry was as project manager for a product registration tracking system at one of the big drug companies. The system held the registration status of all of the company’s products worldwide - whether the product was submitted for approval in a given country, approved for marketing, [...]


ROXRO Pharma: How to Score Big as the (Really) Little Guy

Last week I attended a Pharmaceutical Executive web conference called “A Better Way to Conduct Alliance Management”.  The conference was somewhat interesting, but in reality, it was more of an hour long advertisement for Intralinks, the conference sponsor.  However, one of the speakers at the conference intrigued me: Gayle Mills, Executive Vice President of Business [...]


Money to Burn

I want to be a CEO of a large company one day. I suppose I’m getting a little taste of the work involved in being at the top since I became a partner at my company, but for this company, it was a pretty short ladder to climb…my partner one day asked me if [...]


Succeeding in Spite of a Black Box

One of my family members once used Pfizer’s Celebrex to help her cope with her arthritis. I remember her disappointment when she stopped taking it because of the cardiovascular problems associated with CO2 inhibitors first uncovered with Vioxx. Another family member depended on Zelnorm to control stomach problems, and was profoundly disappointed with [...]


Seeing Double: Pet Cloning

In 1996, the scientific community saw a breakthrough when Dolly the sheep was deemed the first animal cloned from an adult sheep cell. With the breakthrough came a slew of moral questions asked by any number of groups. Were we playing God? Were we going too far? What kinds of problems [...]


Ironing Out the Wrinkles

It’s late, and I’m sitting here at squinting at my computer screen most likely because I’ve positioned it too far away from my eyes. At least, that’s what I keep telling myself to make myself feel better.
I believe at some point in my life I will need glasses. I’ve been lucky so far, [...]


Super Blog

This week seems to be a week for supers. The Superbowl was on Sunday, with the New York Giants defeating the near-perfect New England Patriots in a stunning upset and deserved victory. Today is Super Tuesday, and Democrats and Republicans are vying for the top candidacy spot in their respective parties. And [...]


Gone to the Birds

In the throes of a bad cold/flu season for me (I’ve been sick three times this winter, possibly a new record), I was reminded today of the media attention a couple of years ago that surrounded the avian bird flu, also known as H5N1, when it promised to be the new flu pandemic [...]


Need Money, Will Warn of Dangerous Drugs

The FDA was once identified as a gold standard of government agencies, taking its responsibility to the public safety very seriously. It was a key player in mitigating some potentially disastrous events in our short pharmaceutical history, as I explored in, “A Brief FDA History Lesson.” In recent months, however, it has come [...]


Personal Doctor in my Pill

You may remember my article about Swiss experimentation with Microbots and their potential for use in new surgical procedures in the future. Being a technology professional, I’m amazed when we can identify ways to leverage technology to make things smaller or to make smaller things do more. Along those lines, I was fascinated [...]