"By focusing on the fate of one small company, Joseph Gulfo has written a riveting tale of how the FDA slows down crucial medical innovations, just when we need them the most. Policymakers on both sides of the aisle should absorb his prescriptions for fixing the system.
Michael Mandel, PhD Progressive Policy Institute
"Finally, an incisive look at the path that medical innovation takes through the FDA, the courts and the public advocacy groups and the crippling effect it has on advancing new treatments to treat and diagnose disease. Today’s regulatory/legal/public advocacy complex is stifling progress and killing medical breakthroughs. Joseph Gulfo lays out why this has happened, how to fix it and how to make all our voices heard."
Nancy Lurker, CEO, PDI Inc.
"Finally, a behind-the-scenes look at the mysterious and often poorly executed approvals process of the FDA. An important book for consumers, physicians, investors, and scientists - anyone who is interested in medical advances that can save lives."
Joseph Pieroni, retired CEO and President, Daiichi Sankyo Inc.
“Dr. Gulfo has written an important book that deserves to be read by everyone interested in having access to new medical treatments. The enormous and all too often insurmountable challenges in bringing breakthrough medical products to doctors are not unique to small biotech and medtech companies, rather, even the industry-leading firms struggle against these forces. 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
"By focusing on the fate of one small company, Joseph Gulfo has written a riveting tale of how the FDA slows down crucial medical innovations, just when we need them the most. Policymakers on both sides of the aisle should absorb his prescriptions for fixing the system.
Michael Mandel, PhD Progressive Policy Institute
"Finally, an incisive look at the path that medical innovation takes through the FDA, the courts and the public advocacy groups and the crippling effect it has on advancing new treatments to treat and diagnose disease. Today’s regulatory/legal/public advocacy complex is stifling progress and killing medical breakthroughs. Joseph Gulfo lays out why this has happened, how to fix it and how to make all our voices heard."
Nancy Lurker, CEO, PDI Inc.
"Finally, a behind-the-scenes look at the mysterious and often poorly executed approvals process of the FDA. An important book for consumers, physicians, investors, and scientists - anyone who is interested in medical advances that can save lives."
Joseph Pieroni, retired CEO and President, Daiichi Sankyo Inc.
“Dr. Gulfo has written an important book that deserves to be read by everyone interested in having access to new medical treatments. The enormous and all too often insurmountable challenges in bringing breakthrough medical products to doctors are not unique to small biotech and medtech companies, rather, even the industry-leading firms struggle against these forces. 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
From the Back Cover
How do you convert a potentially life-saving new idea into an actual medical product and then make it available to doctors and patients? Joseph Gulfo thought he knew what to do…but he thought wrong.
What was supposed to be a “no-brainer” became a decade-long struggle of Herculean proportions. One that included a surprise―and unlawful―withholding of approval by the FDA. A fighter by nature, Dr. Gulfo refused to back down and led the company, including exposing bureaucratic malfeasance by FDA officials and filing an unprecedented Citizen Petition in the middle of an active FDA review. Gulfo raised more than $150 million in eleven separate financings, battled to near death with nefarious short sellers, and finally won over skeptical doctors put off by untruthful and misleading statements from the agency that was doing the opposite of its statutory mandate to promote the public health.
The book may read like a suspense thriller, but sadly, it is a true story!
So affected by his experience fighting the FDA, Dr. Gulfo now wants to fix the system that is impeding the release of advance breakthrough medical products. He offers a detailed Medical Innovation Manifesto that is a prescription to do just that.
About the Author
Joseph V. Gulfo, MD, MBA is the author of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances. He has more than 25 years of experience in the biopharmaceutical and medical device industries. In 2012, he received the American Business Awards’ Maverick of the Year Award and was an Ernst & Young Entrepreneur of the Year Finalist. Dr. Gulfo also teaches graduate Cancer Biology and business classes in entrepreneurship.
He is currently CEO of Breakthrough Medical Innovations, a team of industry experts specializing in Biopharma/Medtech product and commercial development, sales and marketing, regulatory (FDA and CE), quality, and policy advocacy. Prior to this, he served as President & CEO at MELA Sciences from 2004 - June 2013, and was Chairman of the Board from November 2011 through June 2013. While at MELA Sciences, he was responsible for (1) effecting an IPO in 2005 and consummating 11 public financings totaling ~$160 MM: (2) obtaining FDA approval of MelaFind, a breakthrough PMA smart diagnostic device for early melanoma detection through which he gained national attention for the process that included the issuing an illegal not approvable letter by FDA, a Citizen Petition filing requesting that the FDA enforce the company’s Binding Protocol Agreement, and a Congressional Hearing at which the FDA admitted the error; and (3) launching MelaFind in US and Europe, and placing MelaFind systems within 75 miles of 63% of the US population in the first 12 months on the market.
He was responsible for the 1998 NDA approval of Valstar (as President & COO of Anthra Pharmaceuticals and Chairman of its UK Subsidiary), a drug for superficial bladder cancer, which had sales of $27 MM in 2012, 14 years after its approval. He was also responsible for the development of ProstaScint (Cytogen Corporation), a BLA-approved monoclonal antibody for prostate cancer. He is currently on the board of directors and audit committee of Procertus Biopharma, a company developing palliative care products for radiation dermatitis and oral mucositis. Dr. Gulfo was CEO and Chairman of Antigen Express, an immunotherapy company in the field of vaccines for cancer therapy, antiviral therapy, and asthma, responsible for its merger.
He received his MD from University of Medicine and Dentistry of New Jersey, and his MBA from Seton Hall University. Dr. Gulfo is a leader in medtech / biopharma innovation, a skilled entrepreneur, manager, and product/market development executive. He lives in New York with his wife, Adele.
