Thursday, August 13, 2015

David's New Book - The Drug Makers

Hello all you blog readers out there!  I’m writing today to let you know that I’ve written a new book that was just published – The Drug Makers. To my surprise, my last book, Antibiotics - The Perfect Storm, sold over 12,000 copies and sales are still coming in even though Springer keeps raising the price! 

The blurb from the back cover of The Drug Makers is copied here –

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.

“The world is full of myth and lore about…pharmaceutical companies. David Shlaes has laid that world bare…an insider’s view, a brutally honest exposé…a story of triumph over adversity.”
—Brad Spellberg, chief medical officer, LAC-USC Medical Center.

The book is available via the publisher, Lulu, Amazon and Barnes and Noble. Unlike my previous book, the digital version of The Drug Makers is $8-9!  Also, unlike my previous book, this one is a work of fiction. You should consider it to have been well researched. You will get an accurate idea of what its like to work in the industry. How do scientists deal with work where 95% of everything they do results in failure? (Hint – focus on the science). How do projects move forward in industry? (With the most unbelievable difficulty).  Who makes decisions? (Frequently they are made by people who have or believe they have some personal stake in the outcome of the decisions).   What is the basis of these decisions? (They are based on highly fallible data – usually from marketing – or they are even based on inaccurate science). How does an individual move projects forward in such a system? (Its not easy and it usually takes a village or even a city). In spite of all this, miraculously, there are successes and important drugs (antibiotics) do occasionally make it all the way to the market. 

The book exposes the inner workings of large companies, mid-size companies, biotechs, start-ups, and even academics trying to carry out antibiotic discovery and development. In the midst of it all, you see how a fictional protagonist keeps swimming upstream. If you enjoy this blog, you will like the book.

Tuesday, August 11, 2015

World AMR Congress

I am writing today to inform you about a meeting that will take place in Washington October 19-20 this year. I am highlighting the meeting in my blog because I think it is of such a broad and unusual character for a small meeting format and because the topics covered are so important.  The agenda includes everything from drug discovery in large pharma, mid-size pharma, biotech and academia.  The clinical development of new antibiotics will also be highlighted by various companies.  Clinical development strategies and the regulatory approach to antibiotic development will be debated.  The federal government's role in antibiotic discovery and development will be covered by the horses themselves - the NIH and BARDA in the US. The important topic of pull incentives for antibiotic development including so-called de-linking and models for such will be discussed. The Pew Charitable Trust will be there. Antimicrobial stewardship is on the agenda.     The schedule incorporates plenty of time for discussion both during the sessions and in more private settings.

There seem to be two key weaknesses in the agenda.  First, the regulatory agencies, FDA and EMA,  seem not to be represented among the speakers.  Secondly, the meeting would have benefited from a greater European presence.  This is especially unfortunate since that is where much of the action is occurring these days. But these downsides aside, the agenda is already broad and interesting.

Your's truly will be there to help keep things moving along and to challenge speakers with questions in my inimitable style.