Blog

The Drama in Drug Development

In 2005, playwright David Mamet* wrote a memo to the writers of the TV show The Unit that went viral on the internet. I have taken some liberties to adapt the memo to pharmacometricians on drug development teams. If you read the online version of the real memo, you will see that I did not have to do much editing, save for redefining the word “drama.”

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The problem with gaps.

After writing about gap analysis for the Pharma of the Future? blog, I went in search of an example that would illustrate the problem of defining “gaps” and stumbled on a piece called Reading and Guilty Pleasure in the New York Times. The writer, Gary Gutting, describes 2 assumptions underlying the concept of a guilty pleasure: some books are objectively inferior to others, and “better” books are generally not very enjoyable. So, are “better” books actually better? Gutting says that in discussions of this sort, people will often adopt a relativist position:

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So, how cold was it?

We’ve had a cold winter so far in the USA, don’t you think? Snow in Alabama, a blizzard in Boston, another in Chicago, an ice storm in Dallas before the Super Bowl. . .Yep, it’s cold outside. But, take a look at this picture from 100 years ago. It’s hard to imagine how cold it had to have been to make Niagara Falls freeze over.

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Square Pegs in Round Holes?

A crusading scientist identifies a potential public health threat and uses the internet to get access to a cache of data from several studies. After a quick analysis of the pooled data, he reports a previously unrecognized adverse effect of a widely used drug. Patients and physicians become alarmed, and the drug is pulled from the market. Sound like the plot of a new medical thriller? In fact, a similar scenario has hit the headlines several times in the last 10 years. Each time, controversy about the validity of the analysis and conclusions was loud and lasting.

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Beauty and the Beast?

Several large Pharma companies have announced interest in acquiring small biotech companies. Many Pharma companies have reduced or eliminated drug discovery efforts, and with stock prices back at 2003 levels, there certainly is a great deal of sense in these acquisitions. But finding another way to integrate these companies and their development portfolio also makes a great deal of sense.

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Insight…Inspiration…Innovation

Welcome to the beginning of 2013. Most of us, I bet, had a challenging 2012, certainly it was stressful, but there is so much to be grateful for and, if one is optimistic, there are many opportunities that are full of promise for the New Year.

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MAA Found Math

Each week, the Mathematical Association of America website posts a new math-related photo that was submitted by an MAA member. The photo reposted here is a decorative Venn Diagram on a ceiling light that was featured on May 31, 2011. The photographer was Joy Hsiao of Brooklyn Technical High School. Visit the MAA Found Math gallery to view more of these fascinating photos.

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A short tour of the universe.

If you want a cheap but out-of-this-world vacation, a short tour of the universe may be just what you are looking for. This video was posted by Adam Frank last January on a National Public Radio blog called 13.7: Cosmos and Culture.

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Kerfuffle! (pt 1)

A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other errors that seem to gain in severity and impact. Kerfuffles can appear in any line of work or play that involves a linked series of tasks with downstream implications. In fact, the modeling and simulation activities performed to support model-based drug development have the potential to produce a catalogue of kerfuffles that can culminate in the failure to deliver modeling and simulation results when they are needed for decision-making. Kerfuffles often have their origins in inadvertent oversights committed early in the study design and data collection process or in the commonplace shortcuts taken to deliver preliminary (“quick-and-dirty”) results for internal use.

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Simulations Plus to Acquire DILIsym Services, Inc.

Accretive acquisition to expand Simulations Plus offerings by adding leading provider of drug-induced liver injury (DILI) software and consulting services

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