Description: CONDITION: NEW c. 2017 Post Hill Press trade paperback, reprint edition, no printing given. Just a very few B&W charts throughout. As we all considered during the FDA-Alzheimer's disease debacle of a couple of years ago, there may be big problems with the FDA. CONTENT: Winner of Maverick of The Year Award and Ernst & Young Entrepreneur of the Year Finalist, and featured by WSJ, Fortune and Bloomberg TV for his battle to defeat unlawful actions by the FDA, Dr. Joseph V. Gulfo provides a first-hand riveting account of an against-all odds fight that demonstrates what it takes to advance breakthrough medical products that truly benefit patients. Having been responsible for the development and FDA approval of three innovative cancer products, he provides the reader with ringside seats to the struggles that entrepreneurs of biotech and medtech companies must fight to successfully bring ideas to marketed innovative products that truly advance the lives of patients. As exclaimed by one real-life witness to a high profile public battle recounted in the book, “It was like watching Gladiator!” The only difference is that this really happened. Sometimes life is more dramatic and unbelievable than fiction; the courtroom-like trial in front of FDA’s medical Advisory Panel is certainly one of those times. A second was the “declaration of war” – filing a Citizen Petition against the FDA demanding that it follow its own laws and acts transparently in honoring its binding agreements. A third was a Congressional Hearing at which the FDA subsequently admitted that a mistake was made. The book contains public record facts woven together in a series of compelling stories complete with unique characters and deeply personal insights. Unrelenting focus, even to the level of personal destruction, and leadership through crises are other major themes. Part One describes how medical innovation occurs in small companies and details the challenges in moving those start-ups along a course that is anything but straightforward. It addresses issues such as the psychology of inventors and founders versus investors, the challenges of attracting and retaining talent, and the vagaries of early phase product development. Part Two takes a deep dive into the unlawful actions and cover-ups by the U.S. FDA that had to be overcome in our effort to obtain approval of a non-invasive product that saves lives. It is a brutal blow-by-blow account of a public slugfest that forever damaged the company. Part Three explains how the unnecessary and very public battle with the FDA left an indelible mark on the company, a taint that was exploited by nefarious Wall Street actors who then preyed on the company for their own benefit. It details how with a Scarlet Letter on its back and an albatross around its neck, Wall Street’s short sellers and dark pool traders hamstrung the course toward widespread use and adoption. Feel safer? Shipping via USPS media mail within 2 days of order. All books clean. Questions welcome & answered.
Price: 9.79 USD
Location: Austin, Texas
End Time: 2024-11-21T16:57:05.000Z
Shipping Cost: 1.99 USD
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Item Specifics
Restocking Fee: No
Return shipping will be paid by: Buyer
All returns accepted: Returns Accepted
Item must be returned within: 30 Days
Refund will be given as: Money Back
Features: Trade Paperback, Few B&W charts
California Prop 65 Warning: NONE
Format: Trade Paperback
Personalize: No
Item Width: 5.5in.
Date of Publication: 20170307
Number of Pages: 272 Pages
Item Length: 8.2in.
Item Height: 0.9in.
Illustrator: None
Topic: Allied Health Services / Medical Technology, Industries / Pharmaceutical & Biotechnology, Government & Business, American Government / National, Corporate & Business History, FDA Drug Approval Process, Wall Street's Influence on Drug approval
Book Series: Amaerican Medical System
Vintage: No
Era: 2010s
Country/Region of Manufacture: United States
Ex Libris: No
ISBN: 1682613917
Edition: Reprint Edition
Language: English
Publication Year: 2017
Release Title: Innovation Breakdown: How the Fda and Wall Street Cripple Medi...
Item Weight: 9.3 Oz
Book Title: Innovation Breakdown
Intended Audience: Adults
Author: Joseph V. Gulfo
Original Language: English
Artist: Joseph V. Gulfo
Signed By: No One
Narrative Type: Nonfiction
Brand: N/A
Literary Movement: Government & Drug Approval
Publisher: Post Hill Press
Inscribed: No
Signed: No
Genre: Business & Economics, Medical, Political Science, Government Approval Process, FDA Approval process
Personalized: No
EAN: 9781682613917
Type: Trade Paperback
