Initiative for Patient-Centered Innovation


Fairleigh Dickinson University's Initiative for Patient-Centered Innovation (iPCI) is a new program under the FDU School of Pharmacy in collaboration with the University's Center for Healthcare Innovation and Technology.


The mission of the iPCI is to provide students with a rich and exclusive opportunity to enhance their education by applying the lessons of business, pharmacy, public policy, and science taught at Fairleigh Dickinson University. Students will engage, apply, and meaningfully participate in real-world debates, projects, and programs that will help to shape public policy that affects the way biopharmaceutical and related companies conduct business particularly relating to patentable products and devices that lead to the advancement of science and medicine.

The innovative learning environment that the iPCI provides can position students for high-paying and rewarding jobs. Students who participate in iPCI programs and projects will be sought by employers in business, public policy, and the extended healthcare space.


Innovation, particularly in the medical field, is not only vital to the advancement of society, it is a key driver of economic growth. Moreover, it is a costly, time-consuming, highly regulated, and risky endeavor, as chronicled in Innovation Breakdown: How the FDA & Wall Street Cripple Medical Advances, by the Lewis Center’s Executive Director, Dr. Joseph V. Gulfo.

The goal of the iPCI is to create a national dialogue about - and offer solutions to - threats to medical innovations that can truly make huge impacts to the lives of patients and to our society. The threats come from many different sources, including:

  1. Regulation – Food and Drug administration and Federal Trade Commission
  2. Reimbursement – Medicare, third-party payers, Accountable Care Organizations, and PCORI (Patient-Centered Outcomes Research Institute under the Affordable Care Act)
  3. Financing – Securities Exchange Commission, Wall Street
  4. Intellectual Property and Patents
  5. Cost – product development and prices of drugs and devices
  6. Tort Law
  7. Access
  8. Bioethics


iPCI discusses the implications of existing and proposed policies, laws, and practices to

  • expose those that represent a significant hindrance to innovations reaching patients
  • applaud those that foster and expedite the dissemination of safe and effective advancements, and
  • propose policies to address barriers.

Among the programs undertaken are:

  1. The Medical Innovation Impact Index (MI3) - a scoring system for important new proposed regulations and existing policies. This mirrors 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;
  2. 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;
  3. 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.


The iPCI will establish FDU's healthcare academics resources as a national key opinion leader and a much sought after voice in:

  1. Identifying problems that impede truly breakthrough innovation development, dissemination, and adoption
  2. Identifying best practices from systems across the globe
  3. Offering actionable solutions to the most vexing problems and issues
  4. Shaping policy and law
  5. Providing comment and insight as a “subject matter expert” in the area
  6. Creating intelligent dialogue on the most critical and topical issues affecting breakthrough medical innovation

Given Fairleigh Dickinson’s commitment to health sciences and pharmacy, and its geographic location in the country’s medicine cabinet, it is appropriate for us to leverage the expertise and learnings of the extended FDU community to speak out on these vital topics, which are of critical importance to all of us.

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The FDA needs a Conditional Approval Process,
Forbes, May 5, 2016


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