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 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. He teaches graduate cancer biology and maintains a cancer biology blog.

Dr. Gulfo 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. Prior to this, he served as President & CEO of MELA Sciences (2004-2013) and was Chairman of the Board (2011-2013). 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.

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Journal of Medical Device Regulation: Can the US FDA be brought ‘back to the future’?

Sep 9 2017|0 Comments

The 21st Century Cures Act was signed into law on 16 December 2016. Putting aside whether enough funds will be dedicated to enacting Food and Drug Administration (FDA) policies, is this the legislation that will [...]

FDU: FDA Approval Delays for Drugs First Approved Abroad, and the RESULT Act by Eman Makar and Joseph V. Gulfo

Jun 2 2017|0 Comments

This paper examines delays in FDA approvals of drugs that have been on the market abroad. As in-depth examples, we focus on domperidone (Part I) in treatment of gastroparesis and mifamurtide (Part II) for osteosarcoma. We discuss the RESULTS Act (Part III), a bill that would force the FDA to approve drugs that have been approved for marketing in countries with well-respected regulatory systems, as well as our recommendations (Part IV). To download the full paper, visit http://view2.fdu.edu/academics/pharmacy/lewis-center/ipci/policy-papers/download.aspx?id=22774  Read More…

Real Clear Politics: Why the New FDA Chief Matters

May 24 2017|0 Comments

A Life and Death Tale of a Life Saving Drug’s Journey to Market The week before last, with little fanfare, Dr. Scott Gottlieb was confirmed as the new leader of the Food and Drug Administration [...]

FDU: Product Approvability Recommendations from FDA Advisory Committees: Inconsistently Sought, Indirectly Obtained by Joseph V. Gulfo , Jason Briggeman , and Asmaa Gamie

Apr 27 2017|0 Comments

Divisions within the Food and Drug Administration (FDA) often convene meetings of advisory committees, also known as AdComm or Panel meetings. The purpose of many AdComm meetings is for the FDA to obtain outside advice and recommendations on whether to approve a new drug or medical device. Laws and regulations indicate that such Panels are to provide recommendations regarding the approvability of the drug or device by FDA. In this paper we examine recent AdComm meetings to find whether FDA is obtaining Panel recommendations on drug and device approvability in accordance with these laws and regulations. Read More…



Selfless caring is based on a moral belief system that demands that principles and truth are your highest goals and that taking personal responsibility is your defining quality. Selfless caring drives you to leave people and circumstances better than you found them. It is a virtually limitless source of energy that fuels tireless preparation and incessant trial and error and personal reinvention.

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What is your Care Quotient™? Are you Caretensive?
How much do you care to be the best leader you can be?

Employees can sense when their manager and leader cares about the right things in the right ways, and when he doesn’t. And, they are more likely to align themselves and genuinely follow your lead, as well as forgive some foibles and mistakes, if they sense that you care enough to do a great job for the business, communicate to them, and foster their development.

Use the Care Quotient Scorecard to obtain feedback about your leadership skills and areas for improvement. This can be given to employees and peers, as well as your managers, as part of a 360-review process. It can also be used in coaching and in providing leadership training to high-potential employees or with managers and leaders who are not performing at the required level.

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