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 UNIVERSITY OF FLORIDA ON BEHALF OF THE COLLEGE OF PHARMACY
DEPARTMENT OF PHARMACEUTICS
PHARMACOMETRICS AND SYSTEMS PHARMACOLOGY
The United States Food and Drug Administration (FDA) and the University of Florida on behalf of the Department of Pharmaceutics, Pharmacometrics and Systems Pharmacology in Lake Nona and Gainesville, Florida respectively, (the Parties) share interests in promoting scientific progress through exchange of scientific capital in the clinical pharmacology training and research program. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This MOU and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities, consortia and consensus development between the parties and establish the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and research.
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, tobacco products, and cosmetics. 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 within the University of Florida will greatly contribute to FDA’s mission.
The University of Florida’s (UF) Department of Pharmaceutics, housed within the College of Pharmacy (COP), has provided strong national and international leadership in pharmacometrics and systems pharmacology, and has brought significant innovation to these fields. Through its post-graduate education and research program, it is ranked No. 1 in the world as the academic supplier of pharmacometrics reviewers to the Food and Drug Administration’s Office of Clinical Pharmacology, and it is ranked in the top three Colleges world-wide in producing pharmacometricians for industry and academia. Through its education, research and service program, the COP focuses on organization, delivery and financing by preparing regulatory and industry scientists with the knowledge necessary to improve drug development, regulatory science, personalized medicine and public health. UF, located in Gainesville and Lake Nona, is one of the world’s leading biomedical research institutions, producing a sustained stream of scientific knowledge, innovations in drug development and genetic medicine. Generating new knowledge, and sharing it with the public, is at the core of the UF mission and vision. Through this education, training and research program, FDA will gain advanced knowledge, collaboration and the benefit of innovations in pharmacometrics, personalized medicine and systems pharmacology. There will be mutual exchange of information between UF and FDA in order to advance regulatory science and to enable greater success in drug development.
Formal academic education in drug development frequently occurs in a manner which isolates the basic science components from the applied regulatory components. Faculty, students, residents and fellows in academe must be exposed to every component of drug development to most efficiently perform the broad range of duties expected of a clinical pharmacologist at FDA and in industry. UF will provide an educational experience that is dependent upon a background in public health problem solving, with interactions with the FDA, and drug regulation related to pharmacometrics, personalized medicine and systems pharmacology. The FDA will provide specialized training for UF graduate students and fellows to effectively work in the regulatory environment while having them solve clinical pharmacology problems related to FDA’s mission. In working together, UF and the FDA must assure that each party receives mission benefit from any Agreements arranged.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UF. The types of initiatives expected to develop from this MOU include:
- Opportunity to apply for a joint fellowship program at the FDA to advance student education and matriculation into the health and biomedical professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from UF into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Clinical Pharmacology and UF will adhere to the CDER ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter;
- Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
- Opportunities to convene joint meetings for education and research;
- Research collaborations;
- Cooperative international initiatives; and
- Accessing unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate this MOU by reference. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UF and FDA.
IV. General Provisions
- “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of the MOU. “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either use or developed under the activities of the MOU. Rights to Inventions or Intellectual Property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the Parties. Inventorship will be governed by U.S. law. In the case of sole inventorship, ownership will be governed by the policies of the employer of the Invention. In the case of joint Inventorship, ownership of Inventions will be jointly owned. Inventions made under a Federal grant or contract will be subject to the Bayh-Dole Act. Accordingly, all UF employees who work on any project under the MOU shall be required to sign an agreement that effects a present assignment of their future inventions to UF. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party.”
- Institutions within UF 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.
- Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless permitted by applicable law.
- 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. UF individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- 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.
V. Resource Obligations
This MOU represents the broad outline of the FDA and UF’s 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 resources. 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 into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Columbia operate.
VI. Liaison Officers
FDA’s Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Ryan Chatman, Project Specialist
Food and Drug Administration
10903 New Hampshire Avenue
White Oak 51 | Room 2281
Silver Spring, MD 20993
Tel: 301-796-2106 | Fax: 301-796-9907
The individual(s) to whom all inquiries to the University of Florida should be addressed is:
Lawrence J. Lesko, Ph.D., F.C.P.
Professor, Pharmacometrics and Systems Pharmacology
Department of Pharmaceutics
College of Pharmacy
6400 Sanger Road
Orlando, Fl 32827
Associate Director of Research
University of Florida, Division of Sponsored Research
219 Grinter Hall, PO Box 115500
Gainesville, FL 32611-5500
Each Party may designate new liaisons at any time by notifying the other Party's liaison officers in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill their functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated, for any reason, by either Party upon 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the University of Florida operate.
APPROVED AND ACCEPTED FOR THE REGENTS OF FLORIDA CLINICAL PHARMACOLOGY PROGRAM
Signed By: William J. Millard, PhD Executive Associate Dean, UF-COP
Signed By: Brian Prindle
Associate Director of Research, UF
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Signed By: Janet Woodcock, MD Director, CDER, FDA
This is an amendment to the Memorandum of Understanding MOU Number 225-11-0024, dated September 19, 2011, to change the termination date from September 20, 2016 to September 19, 2021. This amendment is permissible under VI. Term, Termination, and Modification. All other terms, conditions, and content of the MOU Number 225-11-2014, executed on August 19, 291, remain unchanged.
APPROVED AND ACCEPTED FOOD AND DRUG ADMINISTRATION
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
July 16, 2016
APPROVED AND ACCEPTED UNIVERSITY OF FLORIDA
Thomas Pearson, MD, PhD
Executive Vice President for Research and Education
at the University of Florida Health Sciences Center
July 16, 2016