Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
In my previous blog “From Science to Fiction” (ACTO, April 15, 2014), I discussed the trials and tribulations of unlearning the scientific writing style, in order to jump into the world of writing fiction. Today I want to discuss the seismic shift that has occurred in the mechanics of the process of book publishing.
Two technical advances have occurred which have shaken traditional publishing to its core. The first is the advent of e-books, well-known to all by now. It seems that virtually everyone owns a Kindle or similar device, and these devices definitely bring convenience (particularly to the clinical trial scientist frequently stuck in airports). The second advance is not as well-known, and this is just-in-time printing. A single copy of a paperback book (with its cover) can now be printed, at low cost. In addition, a significant business-process advancement (which bookstore lovers, including myself, decry) is internet book sales, and we might as well be honest about it and call it what it really is: the success of the company Amazon.
In the old days, there were two publishing worlds, traditional publishing and “vanity” publishing. Virtually all publishing occurred via traditional publishers, and these were the gatekeepers who held the printing presses, the warehouses, and the distribution channels. It was very difficult (and still is) to get a publishing contract because these large publishers need manuscripts which can justify large printing runs and the expense of advertising and distribution. “Vanity” publishers produced books for authors who were willing to pay, and such books were generally looked down upon as of low quality (although there were exceptions such as Walt Whitman’s “Leaves of Grass” and Audubon’s “The Birds of America”).
I’ll cut to the chase. Today, you do not need a large potential audience to publish a book, as long as your goal is not large financial gain. For example, if you want to publish a family history of interest to only twenty-five living people, you can now proceed without having to get through the traditional publishing company gatekeepers. You can format your book online and create a cover using a free service such as Createspace (createspace.com), owned by Amazon. Alternatively, there are other relatively inexpensive companies (including Createspace) that will more actively help you for a fee. If you go the Createspace route, you can have your book seamlessly listed on Amazon, where you set your price and royalty for both paperback and e-versions. While I am sure that Amazon would like to sell lots of books to make lots of money, their efficient on-line sales model permits the listing and sale of books with small, even miniscule, markets. The twenty-five people interested in your family history can buy your nicely produced paperback book on the subject. If only one copy is ordered in a particular month, it doesn’t matter – that copy will be prepared using just-in-time printing.
To bring this closer to home, if you have a desire to publish a book on some aspect of clinical trial design or execution, even an unusually short book, the mechanism exists to accomplish it. For more detailed information on how to self-publish, I strongly recommend the book “APE – Author, Publisher, Entrepreneur” by Guy Kawasaki, formerly Chief Evangelist at Apple Inc. Kawasaki says to forget about “vanity” publishing and to call it “artisinal” publishing instead.
Bill Curatolo’s novel “Campanilismo” is set against the background of international biotech, and involves broken clinical studies, illegal internet pharmacies, and New Jersey hoods. A biophysicist by training, Dr. Curatolo served for six years on the staff at MIT, and for 27 years in the R&D Division at Pfizer. He is the author of numerous scientific publications, and holds thirty-two US Patents. “Campanilismo” is available at Amazon (http://www.amazon.com/Campanilismo-Crime-Intrigue-International-Biotech/dp/0989656608/ref=sr_1_1?s=books&ie=UTF8&qid=1398972428&sr=1-1&keywords=curatolo).