The Drug Makers: A Story from Inside the Pharmaceutical Business
Daniel Simon leaves his job as a professor at a Midwestern medical school to work in the pharmaceutical industry because he wants to make a greater and more direct impact in his field. But he soon finds that in his new role, he must contend with petty crooks, fraudsters, and brilliant but money-hungry researchers. There’s also the U.S. Food and Drug Administration, which seeks to put a regulatory death to what could be lifesaving antibiotics. Whether he’s working at a large company, small company or biotechnology company, he sees how they make decisions, conduct research, and earn revenue. Sometimes, he gets caught in turf battles and must deal with inflated egos. With a career and family to think about, Daniel works hard to bring new antibiotics to the market, but he becomes increasingly frustrated by the hurdles that must be overcome. He has his work cut out for him in The Drug Makers.
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Dec 29, 2016In this short, thinly fictionalized autobiographical account of a life spent in antibiotic drug discovery, David Shlaes provides a master course in the business of drug discovery. With 30 years of experience under his belt and lengthy exposure to the academic, big pharma, and biotech worlds that are center-stage in his book, Shlaes is well positioned to hammer home the points he is rightly famous for: that we need to reform the regulatory path to approve antibiotics, and that we need to change the pricing of antibiotic drugs if we want to continue to generate effective antibiotics in the future. In a breezy and accessible style, punctuated with politics and personality, this story of a single consultant with exposure to all of the major industrial players provides a cautiously pessimistic overview of the current and future state of affairs in antibiotic drug discovery. This book does a good job of describing just where all of the fantastic sums of money required for drug development... More > are spent. And most of these cost sinks are foreign to academics: practically the entire book concerns itself with the post-discovery enhancement of particular molecules on the journey to the clinic. The discovery of these compounds, the place where many academics work, is barely mentioned. And as exceptional as finding a new lead compound is, there is still a tremendous effort to be made, over a long stretch of time, in order to justify the long, expensive process of demonstrating efficacy and safety in real clinical settings. By walking us through the decision making process of a number of these compounds, we are able to understand the gravity of each of these funding meetings and how the balance of factors could easily tip against you at the merest snif of bad news. By bringing us into the boardrooms of pharma companies, David/Daniel are able to describing how the basic economic calculus works and drive home the point that he wants to us all to learn and learn-well: in the absence of regulatory and pricing changes, we will not be able to turn around the decimation of the industrial outfits that have generated most of our antibiotic compounds. This is a quick read full of useful ideas to anyone in the biz.< Less
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- David Shlaes (Standard Copyright License)
- July 23, 2015
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