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MOU 225-12-0010

MEMORANDUM OF UNDERSTANDING
between the
UNITED STATES FOOD AND DRUG ADMINISTRATION
and
MASSACHUSETTS INSTITUTE OF TECHNOLOGY

I. Purpose

The United States Food and Drug Administration (FDA) and the Massachusetts Institute of Technology (MIT) share interests in promoting scientific progress through exchange of scientific capital in training and research and foresee benefits from the mutual exchange of training and research expertise.  This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through information sharing in regulatory science research, training, sabbaticals, postdoctoral fellowships, and student internships.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301 et seq.).  In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  FDA also has a primary role in advancing the translational/applied science that is needed to move promising new technologies into actual manufactured products in the most efficient manner possible while assuring the clinical safety and effectiveness of such products for patient care. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues.  Increased development of research, education, and outreach partnerships with MIT will contribute to FDA’s mission.

MIT has a longstanding history of convergence-model education and research activities involving collaborations among faculty and researchers in engineeering, physical sciences, biological sciences, computational sciences, and social sciences, as well as with scientists/clinicians from academic medical centers and life science companies in the global biopharmaceutical and medical device industries.  MIT’s research activities address a broad range of issues of crucial importance to the FDA in its efforts to advance regulatory science for positive public health impact. Increased development of research, education and outreach partnerships within the MIT will greatly contribute to FDA's mission.

III. Substance of Agreement

This MOU is intended as a broad vehicle to promote programmatic interaction in the form of joint collaboration between FDA and MIT researchers, students, and personnel as well as joint development of relevant scientific research projects.
 
Under this MOU, FDA and MIT will seek opportunities to participate together in collaborative research and training as permitted under appropriate statutory authority.

Before any specific collaboration is initiated or implemented, the parties shall identify priorities and topics of mutual interest, and develop separate, written agreements for each collaboration that will outline each Party’s financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU.  These agreements may include contracts, grants, or cooperative research and development agreements (“CRADAs”) between FDA and MIT to the extent authorized by law and available appropriations.  The terms and conditions of any agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the MIT and FDA.

The intitial area will be in the area of information and material sciences including but not limited to artificial intelligence, advanced statistical machine learning and data mining methods, development and validation of predictive technologies derived from analysis of pre- and post- approval data sets, and manufacturing. Activities in this area may focus on identifying and characterizing toxicology/safety and therapeutic efficacy for various population groups.

Collaboration in any of these, or additional identified areas of mutual interest, may take a variety of forms, such as:

  • Joint research programs formed by scientists from the respective institutions. This research may be based on collaborative analysis of data from FDA files and the literature, or experimental work. The partners will disseminate information and enhance the visibility of the work of the collaboration through mutually agreed upon vehicles including training activities, meetings, and symposia and journal publications. As specific topics for joint research are identified under this MOU they will be conducted under the appropriate formal agreements as required by law.
  • Joint participation and/or sponsorship of conferences, workshops, meetings, or seminars on areas of mutual interest.
  • Joint training activities such as seminars, workshops or short courses arising from complementary interests developed jointly by MIT and FDA and offered to FDA scientists and reviewers, MIT scientists, industry, and others as identified needs arise.
  • Establishment and/or participation in public private partnerships with MIT, as an institution, serving as a neutral convener and/or intermediary to enable multi-stakeholder collaborations including government, industry, and academia.  Examples of such existing public private partnerships at MIT focus on New Drug Development Paradigms (NEWDIGS), Biomanufacturing (BioMAN), Adventitious Agent Contamination in Biomanufacturing (CAACB), Biomedical Enterprising, Medical Sciences, Radiological Sciences, Clinical Biomedical Engineering, and Clinical Investigations.

Initial activities associated with this MOU will be explored through a workshop involving participants from MIT and the FDA, as well as other key stakeholders involved in the life sciences industry (e.g., NIH, industry, and others). 

IV.   Participants


A wide range of faculty, graduate students, and research staff from the Schools of Engineering, Science,  Management, and Social Sciences, from a variety of disciplinary fields, would be potential participants from MIT. Senior scientists and policy officials from the Commissioner’s Office, and scientists and reviewers from the Product Centers and Offices of  FDA would be participants from the FDA. Other participants could include scientists and experts from industry, field laboratories, and other institutions identified for collaborative activities in the areas described above.

V. General Provisions

  1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
  2. Institutions within the MIT and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
  3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
  4. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason.  The MIT individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
  5. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.


VI.  Resource Obligations


This MOU represents the broad outline of the FDA and MIT intent to collaborate in areas of mutual interest.  It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds.  This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. 
 

 

VI.  Liason Officers

A.Michael P. Corcoran
Assistant Director
Office of Sponsored Program
Massachusetts Institute of Technology
Building E19-750
77 Massachusetts Avenue
Cambridge, MA 02139-4307
Phone (617) 253-3906
Fax (617) 253-4734
mcorcor@mit.edu 

B.Trang Gisler
Supervisory Project Manager, ORSI, OC
U.S. Food and Drug Administration
Office of Regulatory Science & Innovation
10903 New Hampshire Avenue
Silver Spring, MD  20993-0002
Tel: (301) 796-8749
trang.gisler@fda.hhs.gov

C. Brian L. Baker, P.E.
WEAC Center Director
U.S. Food and Drug Administration
109 Holton Street
Winchester, MA 01890
Phone (781) 756-9701
Fax (781) 756-9757
Brian.baker@fda.hhs.gov

D.Nancy J. Pluhowski
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone (301) 796-6660
Fax (301) 847-8510
Nancy.pluhowski@fda.hhs.gov

Each Party may designate new contacts at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

VII.  Period of Agreement

This MOU shall become effective upon the signature of all the Parties and will continue in effect for five (5) years. It may be extended by mutual written agreement of the Parties in writing. It may be modified by mutual consent or terminated by either Party upon a 60-day advance notice to the other Party.

VIII. Statutes, Regulations

This MOU and all associated agreements will be subject to all applicable federal and state laws and regulations.

 

 

APPROVED AND ACCEPTED FOR MIT 

Signed by:Vice President for Research and Associate Provost

Date: 3/28/2012
 

ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

Signed by:Senior Advisor, Regulatory Science and Innovation

Date: 4/16/2012