Teaneck, NJ – According to Hugh Morley of the Record, “Former medical company executive, Dr. Joseph V. Gulfo doesn't want to fight anymore. And that's good news for Fairleigh Dickinson University.” After two years battling to get a melanoma detection device approved by the U.S. Food and Drug Administration, the former CEO of Mela Sciences is now the FDU's Rothman Institute of Innovation and Entrepreneurship.
“Gulfo said that aside from teaching, he wants to raise the profile of the institute by putting to use the lessons he learned as a CEO overcoming the FDA's objections to his company's device – a hand-held scanner that seeks to help doctors determine whether a mole is benign or malignant by using pattern recognition algorithms.”
Subsequently, he has partnered with the University's Center for Healthcare Innovation and Technology to launch FDU’s Initiative for Patient-Centered Innovation (iPCI), set to create a national dialogue and educational opportunities linking lessons of business, pharmacy, public policy and science.
“I don't want to fight anymore,' he said this week, explaining his change of career. I loved managing. And I loved raising money and meeting with investors. It's really educating; I love teaching. But the institute — the ability from an academic standpoint to do things credibly, dispassionately and analytically — is what drove me here."
Among the programs that will be undertaken are:
· The Medical Innovation Impact Index (MI3) - a scoring system for important new proposed regulations and existing policies. This will mirror the “Environmental Impact” assessment that all new projects must include by Federal Law. The goal is to analyze the consequences (unintended and intended) of new and existing policies (FDA, SEC, patent law, healthcare delivery, healthcare payment) on the advancement of patient-centered innovations;
· Shadow Advisory Committee Panels (S-Panel AdComm) - an independent board comprised of patients and the most knowledgeable doctors in a given field to review the merits of new biopharmaceutical products and medical devices pending before the FDA;
· Audit of Regulations and Guidance Documents relative to governing statutes - this will shed light on the ever-growing number of regulations that often get in the way of promising innovations reaching patients, and examine which are helpful to ensuring the availability of safe and effective products compared to those that run counter to actual laws passed by Congress to promote health.
“Gulfo replaces the interim head, Diana Kyser McNeff, who was appointed on the departure of the last permanent executive director, James Barood, who left in July to head the New Jersey Technology Council, a Mount Laurel-based trade group.”
For Hugh Morley's full story: http://www.northjersey.com/news/business/teaching-real-life-lessons-1.1317757
For more information about the initiative: http://view2.fdu.edu/academics/silberman-college/centers-and-institutes/rothman-institute-of-entrepreneurship/ipci/
Subsequently, he has partnered with the University's Center for Healthcare Innovation and Technology to launch FDU’s Initiative for Patient-Centered Innovation (iPCI), set to create a national dialogue and educational opportunities linking lessons of business, pharmacy, public policy and science.
“I don't want to fight anymore,' he said this week, explaining his change of career. I loved managing. And I loved raising money and meeting with investors. It's really educating; I love teaching. But the institute — the ability from an academic standpoint to do things credibly, dispassionately and analytically — is what drove me here."
Among the programs that will be undertaken are:
· The Medical Innovation Impact Index (MI3) - a scoring system for important new proposed regulations and existing policies. This will mirror the “Environmental Impact” assessment that all new projects must include by Federal Law. The goal is to analyze the consequences (unintended and intended) of new and existing policies (FDA, SEC, patent law, healthcare delivery, healthcare payment) on the advancement of patient-centered innovations;
· Shadow Advisory Committee Panels (S-Panel AdComm) - an independent board comprised of patients and the most knowledgeable doctors in a given field to review the merits of new biopharmaceutical products and medical devices pending before the FDA;
· Audit of Regulations and Guidance Documents relative to governing statutes - this will shed light on the ever-growing number of regulations that often get in the way of promising innovations reaching patients, and examine which are helpful to ensuring the availability of safe and effective products compared to those that run counter to actual laws passed by Congress to promote health.
“Gulfo replaces the interim head, Diana Kyser McNeff, who was appointed on the departure of the last permanent executive director, James Barood, who left in July to head the New Jersey Technology Council, a Mount Laurel-based trade group.”
For Hugh Morley's full story: http://www.northjersey.com/news/business/teaching-real-life-lessons-1.1317757
For more information about the initiative: http://view2.fdu.edu/academics/silberman-college/centers-and-institutes/rothman-institute-of-entrepreneurship/ipci/