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.