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  1. Academic MOUs

MOU 225-25-009

MEMORANDUM OF UNDERSTANDING BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF TRANSLATIONAL SCIENCES OFFICE OF CLINICAL PHARMACOLOGY AND THE UNIVERSITY OF MANCHESTER THE CENTER FOR APPLIED PHARMACOKINETIC RESEARCH -CAPKR

This Memorandum of Understanding (MOU) is made and entered into as of the date of last signature by and between the United States Food and Drug Administration (FDA) and The University of Manchester. FDA and The University of Manchester are referred to individually as a “Participant” and collectively as “Participants.”

I. Purpose

The United States Food and Drug Administration and The University of Manchester share interests in promoting scientific progress through knowledge exchange of (1) scientific capital in pharmacology and translational research with regard to characterization of drug metabolism and transport, and (2) quantitative proteomics of transporters and enzymes involved in drug disposition with a view to optimize drug dosing and to create algorithms to help with stratified medicines based on patient attributes. This Memorandum of Understanding (MOU) establishes the framework for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and research.

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, promotes and protects 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 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. To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with The University of Manchester will greatly contribute to FDA's mission.

The University of Manchester is a non-profit, public research and teaching institution established in 1824, covering almost all scientific disciplines. The University of Manchester has several research groups, of which one particularly focuses on systems pharmacology and translational science relevant to drug transporter and enzymes. The aim of this group is to promote better understanding of the role of individual variability in drug disposition and its consequences for pharmacological effect and drug safety, including drug-drug interactions. The above work at the University of Manchester is led by Professor Amin Rostami who is engaged in a series of research programs relating to the handling of optimal drug development and adjusting dosage in special populations. FDA and The University of Manchester have a mutual interest in collaborating and effectively translating research findings to the bedside to benefit the public health.

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and The University of Manchester. The types of initiatives expected to develop from this MOU include:

I. Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from The University of Manchester in the joint fellowship program at the FDA is through the Center for Drug Evaluation and Research's (CDER's) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may also be covered under ORISE. If prospective fellows or faculty members enter the program through the ORISE mechanism, the Office of Clinical Pharmacology and The University of Manchester will adhere to the CDER ORISE fellowship rules, which will be provided upon commencement of the program and outlined in an offer of appointment letter. For more information about the CDER ORISE fellowship program visit: Information for Applicants | Research Participation Program at the U.S. Food and Drug Administration.

II. Opportunities to convene joint meetings for education and research including presentations at conferences and attending advisory board meetings;

III. Research collaborations;

IV. Cooperative international initiatives; and

V. Agreements to allow access to unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and The University of Manchester intend to 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 Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource-sharing. The Participants intend that, when applicable, these arrangements will incorporate by reference this MOU.

IV. General Provisions

The Participants intend that:

  1. Rights to any inventions resulting from collaborative research be determined by the separate written research arrangements governing the effort, based on current U.S., European Union and United Kingdom patent regulations and any other applicable statutes and regulations. For the avoidance of doubt, no intellectual property will be generated under this MOU.
  2. The University of Manchester and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address intellectual property rights and will be subject to negotiation and mutual agreement by the parties.
  3. This MOU does not authorize the sharing of FDA non-public information (NPI). The reference to “non-public information” covered by this agreement includes any information protected from public disclosure under Federal law and regulations, including the Freedom of Information Act (FOIA) and 21 CFR part 20. See also 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 5 U.S.C. § 552a(i)(1), 18 U.S.C. § 1905. This may include: confidential commercial information, trade secret information, personal privacy information, pre- decisional information, deliberative information, and law enforcement records.
  4. Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities. Either Participant may restrict or limit access to its property and facilities at any time and for any reason. The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
  5. The Participants intend that, as research projects are developed, details shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal and The University of Manchester requirements.

V. Resource Obligations:

This MOU represents the broad outline of the intent of FDA and The University of Manchester to collaborate in areas of mutual interest. This MOU is not legally binding and it does not create binding, enforceable obligations against any Participant. All activities that may be undertaken under 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 Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU.

VI. Liaison Officers:

A. For the University of Manchester

Professor Amin Rostami, Ph.D.
Professor of Systems Pharmacology & the Director of CAPKR (Centre for Applied Pharmacokinetic Research), University of Manchester Stopford Building, Oxford Road
Manchester, M13 9PT
Email address: amin.rostami@manchester.ac.uk

B. For the U.S. Food and Drug Administration:

Shiew-Mei Huang, Ph.D.
Deputy Director
Office of Clinical Pharmacology Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: 301-796-1541 I Fax: 301-847-8720
Shiewmei.Huang@fda.hhs.gov

Each Participant may designate new liaisons at any time by notifying the other Participant'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 Participant previously represented by that individual intends to name a new liaison within two weeks and notify the other Participant through the designated administrative liaison.

VII. Term, Termination, and Modification:

This MOU, when accepted by both Participants, will be effective for three years starting on the date of the last signature. It may be modified or terminated by mutual written consent of the Participants or may be terminated by either Participant upon 60 days' written notice to the other.

VIII. Statutes, Regulations, Rules, and Policies

This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA operate.

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION

/s/
By Dr. George Tidmarsh, CDER Center Director
Center for Drug Evaluation and Research (CDER)
Date: 09/24/2025

APPROVED AND ACCEPTED FOR THE UNIVERSITY OF MANCHESTER

/s/
By Dr Andrew Walsh
Executive Director of Research and Business Engagement
Date: 08/01/2025

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