Blog

An Omission a Recommendation and a Prediction

The President’s Council of Advisors on Science and Technology (PCAST) recently issued a report to the President of the United States on propelling innovation in drug discovery, development, and evaluation [1]. It is well worth your time to read the entire report. The Council stated that the pace of new therapeutic development has not kept up with the explosion in scientific knowledge of cancer, heart disease, diabetes, and other devastating diseases. Their recommended actions have the audacious goal of doubling, over the next decade, the rate of invention of new medicines for patients, while increasing drug safety.

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Mind the gap

I was talking with a Program Director the other day about an upcoming regulatory filing. She was rightly proud of the clinical pharmacology work that had been completed, but she was also anxious about possible holes in the package. As we talked, I thought about how gap analyses have changed over the years, particularly since modeling and simulation results have come to play a larger part in the Clinical Pharmacology Summary in NDA submissions.

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Computers win on Oscar night.

Did you watch the Oscars? A year ago, the 3D blockbuster, Avatar, was denied the Oscar for best film, which went to a low-budget war movie called The Hurt Locker. However, Avatar did win 3 Oscars in technical categories: Cinematography, Art Direction, and Visual Effects.

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An Uncommon Vignette?

Part 1
The CEO of a pharmaceutical company, tired of late-stage development failures and FDA questioning regarding dose selection, decides to act on the promise of pharmacometrics. “Fix it,” he says to the head of clinical pharmacology, “I don’t care what it takes!” The clinical pharmacologist agrees to take on the challenge and asks for a data programmer and pharmacometrician. Seizing on an opportunity to spearhead an upcoming “end of phase 2” meeting with the FDA, the pharmacologist quickly sketches out his strategy for the modeling activities required for dose selection and justification. He then instructs his programmer to assemble the required dataset using the data from several phase 1 studies and a recently completed phase 2 study. A week later he discovers that the modeling has not begun because the dataset is still not ready. “What is taking so long?” he wonders.

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John Muir (1838 to 1914) and advice for surviving the Economic Crisis of 2008

John Muir was one of the first climbers to explore and climb many of the peaks in Yosemite Valley in California’s High Sierra. During his first ascent of Mount Ritter in 1872, he became gripped with fear.

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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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