Top 5 books everyone in the biopharma industry must read

In Regulation and Compliance by justineLeave a Comment

books, pharmaceuticals, generics, patents, ethics, fda

 

With such a wide range of information available these days on the complexities of the biopharmaceutical industry, I thought it might be helpful to find some of the top books that should be on everyone's reading list.  Ranging from patent law to pricing, the FDA to ethics, I believe this list of books should have something for everyone.  If there are any I've missed, please let me know by commenting below.  As this is not an exhaustive list, any additional recommendations are much appreciated.

Happy reading!

 

1. The Generic Challenge:

In Martin Voet's book, he provides a concise guide to the necessary information so that pharmaceutical executives, managers, regulatory, legal and business development professionals, those involved in strategic marketing and in research and development, among others in the pharmaceutical ï¬eld, can deal with the increasingly aggressive tactics of generic companies designed to legally copy innovative drug products.

 

2. Ethics and the Pharmaceutical Industry:

By Michael A. Santoro and Thomas M. Gorrie

Despite the pharmaceutical industry’s notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior.

 

3. The Merck Druggernaut: The Inside Story of a Pharmaceutical Giant:

Author Fran Hawthorne, one of the leading journalists covering healthcare, has written an excellent examination of a business paragon with much-needed insight on the cutthroat world of pharmaceuticals. It’s a story that will interest the business world as well as consumer and healthcare advocates by detailing the vital issues in medicine and healthcare today.

 

4. The Strategic Pricing of Pharmaceuticals: 

Author E.M. (Mick) Kolassa explains how pharmaceutical prices are, and should be set, in the US and international markets. The book discusses how pharmaceuticals are different from other products in terms of value and why typical assumptions and approaches to pricing fail to consider the true nature of pharmaceuticals or to capture their value.

 

5. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation: 

Author Alfred A. Knopf

Emerging out of the era of the robber barons and Theodore Roosevelt’s desire to “civilize capitalism,” the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. In the almost one hundred years since, it has evolved from a squad of eleven inspectors dogging dishonest tradesmen into America’s most important regulatory agency, keeping tabs on the products of about 95,000 businesses and more than $1 trillion worth of goods annually. This book shows how the agency combats self-serving political and industrial interests and protects Americans from hazardous medicines, medical devices, and foodstuffs while enforcing rigorous scientific standards.

 

 

 

I know I said only 5, but for those of you looking for a different type of pharmaceutical book on the market, I'm adding in 2 others that are on a different level.  For those looking for a bit of a thriller, try reading…

 

The King of Torts, by John Grisham

The office of the public defender is not known as a training ground for bright young litigators. Clay Carter has been there too long and, like most of his colleagues, dreams of a better job in a real firm. When he reluctantly takes the case of a young man charged with a random street killing, he assumes it is just another of the many senseless murders that hit D.C. every week.  As he digs into the background of his client, Clay stumbles on a conspiracy too horrible to believe. He suddenly finds himself in the middle of a complex case against one of the largest pharmaceutical companies in the world, looking at the kind of enormous settlement that would totally change his life—that would make him, almost overnight, the legal profession's newest king of torts…

 

Cure, by Robin Cook

With her young son’s potentially fatal neuroblastoma in complete remission, New York City medical examiner Laurie Montgomery returns to work, only to face the case of her career. The investigation into the death of CIA agent Kevin Markham is a professional challenge-and has Laurie’s colleagues wondering if she still has what it takes after so much time away.  Markham’s autopsy results are inconclusive, and though it appears he’s been poisoned, toxicology fails to corroborate Laurie’s suspicions. While her coworkers doubt her assassination theory, her determination wins over her husband, fellow medical examiner Jack Stapleton, and together they discover associations to a large pharmaceutical company and several biomedical start-ups dealing with stem-cell research. Laurie and Jack race to connect the dots before they are consumed in a dangerous game of biotech espionage.

 

 

Again, if you have any recommendations, please comment below!

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