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 excled 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 ins. 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 let 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.
The book concludes with The Innovation Manifesto, an actionable list of changes to help fix this horribly broken system,
including reform to the legal system to reduce meritless shareholder lawsuits; securities reform to stop manipulative
trading, analysis, and predatory shorting of small companies; and FDA reform that will bring in leadership that is
committed to, and unafraid of, promoting by proactively advancing the development and approval of innovative
products, rather than simply blocking drugs and devices that are not deemed to be safe. The FDA needs to get back to its
first principles and to stop the propaganda - the author knows how to make that happen.
In medical school and residency, the author was taught to “see one, do one, and teach one” as the means to master a
procedure and to complete the “circle of education.” With respect to biotech and medtech companies that have been
severely compromised by an untenable system, having “seen one, done one, and taught one” he now seeks to “prevent a
hundred” similar unfortunate examples. Continued advancement of our national depends on it.