Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances
| Author | : | |
| Rating | : | 4.37 (929 Votes) |
| Asin | : | 1682613917 |
| Format Type | : | paperback |
| Number of Pages | : | 272 Pages |
| Publish Date | : | 2017-10-27 |
| Language | : | English |
DESCRIPTION:
And, in the end, it’s the patients who suffer.”Brian Leyland-Jones, MD, Vice President, Molecular and Experimental Medicine, Avera Cancer Institute, Sioux Falls, SD“A fascinating read of the relentless challenges a passionate entrepreneur faced and overcame to bring a medical breakthrough to patients.”Susan Scherreik, Founding Director, Seton Hall University Center for Entrepreneurial Studies . Today’s regulatory/legal/public advocacy complex is stifling progress and killing medical breakthro
"Straight from the heart as well as informative. We are lucky that there are leaders like Joe Gulfo out there" according to E. Campbell. What a great personal story as well as a super primer for those thinking of taking the plunge into biomedical start-ups. I have recommended it to many of my friends who are interested in what it takes to lead a new company with smart science in the wild world of Wall Street and the FDA. An amazing description of medical device development and the trials and An amazing description of medical device development and the trials and tribulations of getting a product to market. I couldn't put it down.. There is a great divide in the perception and the actuality of innovative Dr. Gulfo recounts the TRUE and UNVARNISHED FDA approval experience in a manner that does NOT point fingers, and weep openly, but rather seeks to educate on the pitfalls and challenges in gaining marketing approval. It is a MUST read for any Angel, Investor, Analyst, or I daresay, C-level exec in the biotech sector. There is a great divide in the perception and the actuality of inno
Unrelenting focus, even to the level of personal destruction, and leadership through crises are other major themes. 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. 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. 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 compro