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  1. Non-Profit and Other MOUs


The United States Food and Drug Administration (FDA) and the Critical Path Institute (C-Path) (the Parties) share interests in promoting scientific progress through the exchange of scientific capital to develop innovative collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety (Critical Path Public-Private Partnerships).
I. Purpose
The purpose of this Memorandum of Understanding (MOU) is to renew the overarching framework for Critical Path Public-Private Partnerships between FDA and C-Path. This MOU and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs, activities, and consortium between the Parties. This MOU establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of program including collaborative education research, and outreach activities.
II. Background
FDA is charged with assuring the safety and effectiveness of medical products under the Federal Food, Drug, and Cosmetic Act (The Act) as amended (21 U.S.C. 301, et seq.) and the Public Health Services Act, including Sections 351 and 362 (42USC 262, 264). In fulfilling these responsibilities, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of medical products, including drugs, biological products, veterinary products, medical devices and radiological products. FDA also advances the public health by supporting the development of innovative technologies which help to make medical products safer and more effective and available to more patients. As a part of the goal of speeding innovation, FDA’ Critical Path Initiative seeks to identify and address those scientific and technical obstacles to the optimum development of safe and therapeutically important medical products.
In a 2004 white paper now known as the Critical Path Challenges and Opportunities Report, the FDA called attention to a decline in the number of innovative medical products being submitted for FDA approval. To bridge the gap between basic scientific research and medical product development, the FDA created The Critical Path Initiative with a goal of developing improved processes to evaluate the safety and effectiveness of new medical products. In 2005, and with a planning grant from the State of Arizona, C-Path was founded as a 501(c)(3) corporation based in Tucson.
In 2007, Congress explicitly authorized the FDA to enter into Critical Path Public-Private Partnerships in Title VII, Section 603 of H.R. 3580, the Food and Drug Administration Amendments Act (codified at 21 USC 360bb-5).
C-Path is an independent, non-profit institute created in 2005 by the University of Arizona and the FDA at which time an MOU was established with the agency. C-Path is dedicated to bringing scientists from the FDA and the European Medicine Agency, industry, an academia together in collaborative research endeavors to improve the path for innovative new product development to reach patients in need. Based in Tucson, AZ, C-Path’s programs address scientific, safety, and educational aspects of medical product development in support of the FDA’s Critical Path Initiative.
III. Substance of Agreement
This MOU may facilitate joint collaboration through public private partnerships with the goal of developing new tools to inform medical product development. The area of collaboration would include but are not limited to:
Consortia: Parties will jointly create and participate in activities of complementary interest that are important to the public health, which may include but are not t limited to: imaging, biomarkers, and biosignatures, proteomics and genomics, qualitative disease progress models, clinical trial design, and other Ares that will enhance medical product development.
This priority work may be executed through collaborations and consortium activities in public health priority areas such as, but not limited to:
1)      Predictive Safety Testing Consortium (PSTC)
2)      Patient-Reported Outcome Consoritium (PRO)
3)      Electronic Patient Reported Outcome Consortium(EPRO)
4)      Coalition Against Major Diseases Consortium (CAMD)
5)      Critical Path to Tuberculosis Regimens Consortium (CPTR)
6)      Polycystic Kidney Disease Outcomes Consortium (PKDOC)
7)      Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
8)      Coalition for Accelerating Standards and Therapies (CFAST) Initiative
9)      International Neonatal Consortium
Training/Education programs: Parties will develop joint activities arising from complementary interests, and offer these activities to academia, industry, and others as identified needs arise.
The parties will disseminate information through mutually agreed vehicles including training activities, meetings, workshops, and symposia.
IV. General Provisions
C-Path assures in this MOU with the FAD that the results of the Critical Path Public Private Partnership projects will not be influenced by any source of funding.
V. Resource Obligations
This MOU represents the broad outline of the Parties’ present intent to enter specific agreements for Critical Path Public –Private Partnership projects in areas of mutual interest to FDAS and the participating parties. All activities undertaken under this MOU are subject to available personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which DA and the participating Parties operate.
This MOU supersedes the MOUs executed on October 17, 2005 and May 19, 2010, but does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU.
VI. Liaison Officers:
For the Critical Path Institute:
Martha A. Brumfield, PhD
President and CEO
Critical Path Institute
1730 East River Road
Tucson, AZ 85718
Telephone: 520-547-3440
Fax: 520-547-3456
For the Food and Drug Administration:
ShaAvhree Buckman-Garner, PhD, FAAP
Director, Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Building 21, Room 4554
10903 New Hampshire Avenue
Silver Spring, MD, 20993
Telephone: 301-796-26000
With copy to:
Susan McCune, MD
Deputy Director
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Building 21, Room 4558
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone: 301-796-1709
Each Party may designate new liaison at any time by notifying the other Party’s administrative liaison on writing. If, any time, an individual designated as a liaison under agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Terms, Termination and Modification:
This agreement will be effective when accepted by all participating parties. This agreement may be modified or terminated by mutual written consent by the parties or may be terminated by either Parties upon a 30 day advance written notice to the other.
Martha A. Brumfield, PhD
President and CEO
Critical Path Institute 
April 9, 2015
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research 
April 9, 2015


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