Initiative for Patient-Centered Innovation

iPCI – Initiative for Patient-Centered Innovation

Fairleigh Dickinson University's Initiative for Patient-Centered Innovation (iPCI) is a new program under the Rothman Institute of Innovation and Entrepreneurship (within the Silberman College of Business) in collaboration with the University's Center for Healthcare Innovation and Technology.

MISSION

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, practically 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.

Moreover, the innovative learning environment that the iPCI provides will well 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.

GOAL

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 Rothman Institute’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

MAKING A DIFFERENCE

We will discuss the implications of existing and proposed policies, laws, and practices in an effort 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 that will be undertaken are:

  1. 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;
  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.

NATIONAL REACH

The iPCI will establish the Rothman Institute of Innovation and Entrepreneurship 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.

In the News

Ending the Prescribe-Don't-Tell Charade for Off Label Drugs, Our American Network, May 19, 2016

A hearing brought to tears over Right to Try legislation, The Hill, May 17, 2016, by Joesph Gulfo, contributor

Time for National Right to Try Legislation, The Hill, May 10, 2016, by Joesph Gulfo, contributor

The FDA Needs a Conditional Review Process, Forbes, May 5, 2016

Ending the Prescribe - Don't Tell Charade for Off-Label Drugs, The Wall Street Journal, March 27, 2016

Criticism of the process: how regulation kills medical innovation and hurts patients, Policy and Medicine, March 14, 2016

The FDA must return to its public health mission, The Hill, March 4, 2016

FDA must focus on drug safety and effectiveness, not patients' life outcomes, The Hill, February 19, 2016

Meet FDA critic Joseph Gulfo, the Antonin Scalia of the life science,  Boston Business Journal, February 17, 2016

A Medical Ecosystem Gone Awry US News and World Reports, January 4, 2016, by Joseph Gulfo

Appropriate oversight is needed to change FDA behaviors, not more laws The Hill, December 22, 2015, by Joseph Gulfo, contributor

Medicare negotiating with pharma is not the answer The Hill, December 4, 2015, by Joseph Gulfo, contributor

Leadership Happens ICMA Publications-PM magazine, October 2015, by Joseph Gulfo

How FDA can settle the off-label use vs. off-label-promotion conflict The Hill, October 5, 2015, by Joseph Gulfo, contributor

Patients are tired of waiting on the FDA Forbes Opinion, September 9, 2015, Guest post by Joseph Gulfo

MI3 alert bemoans negative impact of MDUFA, PDUFA, BioWorld, August 27, 2015 (V. 26 No. 163), by Mari Serebrov

Different approach to FDA user fee reauthorizations needed The Hill, August 26, 2015, by Joseph Gulfo, contributor

How Best to Change FDA's Combination Products Regs? MD+DI, August 7, 2015, by Marie Thibault

Fixing the FDA's broken combination products policies The Hill, August 5, 2015, by Joseph Gulfo, contributor

Combination Products Review Process MI3 Alert, July 29, 2015, by Joseph Gulfo

Why the 21st Century Cures Act is a Mistake The Daily Caller, July 9, 2015, by Joseph Gulfo

Go on, take the money and run, as usual The Hill, July 6, 2015, By Joseph Gulfo

FDA empowered to act, but doesn't The Courier-Journal, July 13, 2015, by Joseph Gulfo

Clearly, the FDA is not Listening The Denver Post Opinion, June 20, 2015, by Joseph Gulfo

New FDU Rothman Institute ED Joseph Gulfo to Speak at MD&M East PMPNews.com, June 3, 2015 (Matthew Sanderson)

Why we need a Medical Innovation Impact Index The Hill, May 28, 2015, by Joseph Gulfo

Corrupting the Common Cure: The FDA's 'orphan drug' efforts are warping the incentives for pharmaceutical research U.S.News, April 27, 2015, by Joseph Gulfo

Making a Breakthrough Mistake with Medical Devices The Daily Caller, April 23, 2015, by Joseph Gulfo

PR efforts at the FDA put the cart before the horse The Hill, April 22, 2015, by Joseph Gulfo

 

MI3 Alerts

Congressional Oversight of FDA - Release date, November 30, 2015

Medicare Negotiating Drug Prices  Release date, October 30, 2015

Off-Label Drug Use and Promotion - Release date, September 16, 2015

PDUFA/MDUFA 2017 Reauthorization - Release date August 25, 2015

Combination Products - Release date, July 24, 2015

Inter Partes Review plus Stock Shorting - Release date, June 24, 2015

Expedited Access Pathway - Release date, May 27, 2015

 

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