Intelligent Wondering 8211 Investigative Clinical Pharmacology
Reviews of new drug applications by regulatory authorities worldwide grow ever more rigorous. I think that one reason for this heightened scrutiny is that reviewers have, over the last 10 years, read many submissions containing results of pharmacometric modeling and simulation analyses. With the use of modeling, explorations of the determinants of drug efficacy and safety are more thorough, and the analyses provide solid support for dose recommendations and labeling content. In short, I think that model-based analyses have raised reviewers’ expectations.Read On
Inventors and innovation
Elmer Sperry (1860-1930) is remembered as the father of cybernetic (feedback control) engineering. He was the author of more than 350 patents in a wide range of fields, and he developed gyro-controlled steering and fire control systems used on Allied warships during World War I and World War II. He was among the first of the independent inventors of the early 20th century to be elected to the National Academy of Sciences (1).Read On
Astronomy picture of the day.
During the time that I was a clinical pharmacology fellow with Lewis Sheiner and Stuart Beal in San Francisco, the Voyager mission  was sending back incredible images of the moons of Jupiter and the rings of Saturn.Read On
Intro to Pharma of the Future?
Why is it so hard to incorporate modeling and simulation into drug development? Why do these powerful tools so often fail to provide satisfactory outcomes?Read On
Dan Carlin’s Hardcore History
In Dan Carlin’s Hardcore History podcasts, the past is twisted and turned upside down in novel and intriguing ways. Dan Carlin, a veteran journalist and radio talk show host, emphasizes the drama of past events and personalities to reveal why history matters today.Read On
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 . 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.Read On
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.Read On
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.Read On
An Uncommon Vignette?
Part 1Read On
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.
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.Read On