Simulations Plus

Carole King, a songwriter and singer who has 4 Grammy Awards, was interviewed last spring by Terry Gross on the nightly NPR program, Fresh Air.

Scientific excellence–asking the right question, then designing and conducting a valid study that answers that question and influences future research–is widely accepted as a benchmark for success in research. However, excellence of a more complicated sort is required in Pharma research. For example, excellence in pharmacometric modeling and simulation has to encompass 3 types of excellence: strategic, operational, and technical.

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).

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:

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.