About the Author
Joseph V. Gulfo, MD, MBA, is the author of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances and contributor of Inc.com's Diagnoses from the Trenches column. A faculty member of the GLG Institute, 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. He teaches graduate cancer biology and business and entrepreneurship classes and maintains an educational cancer biology blog.
Dr. Gulfo is currently Executive Director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University, and a Visiting Scholar at the Mercatus Center of George Mason University, a policy research, education, and outreach organization focusing on market-based solutions. He is also CEO of Breakthrough Medical Innovations, a team of industry experts specializing in biopharma and medtech product and commercial development, sales and marketing, regulatory (FDA and CE), quality, and policy advocacy. Prior to this, he served as President & CEO of MELA Sciences (2004-2013), and was Chairman of the Board (2011-2013). While at MELA Sciences, Dr. Gulfo was responsible for:
- Effecting an IPO in 2005 and consummating 11 public financings totaling ~$160 MM
- 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 of 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
- Launching MelaFind in the US and Europe
- Placing MelaFind systems within 75 miles of 63% of the US population in the first 12 months on the market
Additionally, 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. Dr. Gulfo was also instrumental in the development of ProstaScint (Cytogen Corporation), a BLA-approved monoclonal antibody for prostate cancer. He was CEO and Chairman of Antigen Express, an immunotherapy and immunodiagnostics company in the field of vaccines for cancer therapy, antiviral therapy, and asthma, and led its merger.
A serial entrepreneur, Dr. Gulfo is a leader in biopharma and medtech innovation. He is passionate about removing obstacles to breakthrough innovation, managing start-up companies, cultivating young managers, and developing products that can make a huge difference in the lives of patients and individuals. He received his MD from University of Medicine and Dentistry of New Jersey, and his MBA from Seton Hall University. Dr. Gulfo lives in New York City with his wife, Adele.