Joseph V. Gulfo, MD, MBA, is the author of The Care Quotient: Transforming Business Through People (September 2016) and Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances (June 2014). He is Executive Director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University (FDU) where he is spearheading the Initiative for Patient-Centered Innovation and also serves as a Professor of Health Sciences. He is a Senior Fellow at The Progressive Policy Institute and author of a Mercatus white paper, The Proper Role of the FDA for the 21st Century. Dr. Gulfo teaches graduate cancer biology and maintains a cancer biology blog. 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, he 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
Dr. Gulfo has more than 25 years of experience in the biopharmaceutical and medical device industries. As President & COO of Anthra Pharmaceuticals and Chairman of its UK subsidiary, he was responsible for the 1998 NDA approval of Valstar, 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. In 2012, he received the American Business Awards’ Maverick of the Year Award and was an Ernst & Young Entrepreneur of the Year Finalist.
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 recently testified in front of the Homeland Security and Government Affairs Committee on “Connecting Patients to New and Potential Life Saving Treatments” and his work has been published in the Wall Street Journal, Forbes, CNBC, US News & World Report, and other national publications. He is a regular contributor to The Hill and is a National Science Foundation I-Corps Grant Reviewer
He received his MD from Rutgers New Jersey Medical School (formerly University of Medicine and Dentistry of New Jersey), and his MBA from Seton Hall University. He is on the Life Sciences Council of Springboard Enterprises, a business accelerator for high growth companies led by women.