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  1. FDA Memoranda of Understanding

MOU 225-18-21

Memorandum of Understanding
between U.S. Department of Health and Human Services,
Food and Drug Administration,
Center for Drug Evaluation and Research,
Office of Translational Sciences,
Office of Clinical Pharmacology
and Board of Regents of The University System of Georgia
by and on Behalf of the University of Georgia

  1. Purpose

    The United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology (FDA) and the Board of Regents of the University System of Georgia by and on behalf of the University of Georgia (UGA) (the Parties) share interests in promoting scientific progress through exchange of scientific capital in clinical pharmacy and pharmacology training and research programs and related areas. Both institutions foresee benefits from the mutual exchange of training as well as clinical and research expertise in pharmacotherapy, biopharmaceutics, 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 research, student training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.

  2. 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, as well as advancing the public health through regulation of tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in clinical practice and research was well as communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with UGA will greatly contribute to FDA’s mission. UGA’s 17 colleges and schools include a college of Pharmacy, Public Health, Veterinary Medicine, as well as a joint Augusta University/UGA four-year medical education program. UGA has stated that it is committed to improving the quality of life for all through pivotal advancements in fields such as vaccine development, biomedical research, cybersecurity, and plant sciences. UGA offers a statewide network that enhances community outreach, service and research. UGA is developing unique approaches for personal and career development programming for its faculty which could be applicable to the regulatory scientist, advancing bench-to-bedside clinical and translational science.

    UGA’s Department of Pharmaceutical and Biomedical Sciences and Department of Clinical and Administrative Pharmacy, housed within the UGA College of Pharmacy (COP), has provided national and international leadership in pharmacotherapy, biopharmaceutics, outcomes science and systems pharmacology. For example, the UGA COP is home to:

    • A campus-wide collaborative Drug Discovery Core laboratory designed to hasten the development of therapeutic drugs for a number of major diseases. The lab enables researchers to rapidly screen these chemical libraries in miniaturized models of various diseases using robotics and high-throughput signal detection to identify potential toxicity of the compounds as wells as characterize pharmacokinetics;
    • Clinical and Experimental Therapeutics (CET) group that conducts nationally and internationally recognized translational research from laboratory to patient bedside;
    • Pharmaceutical Health Services, Outcomes, and Policy group that conducts both research and practice focused on health economics and pharmacoeconomics, public health policy, and analysis of the outcomes of health care delivery with the aim of improving outcomes in health services and pharmaceutical care delivery; and
    • A network of practicing pharmacists in a variety of clinical, community, and rural settings. The UGA COP cofounded the Southeastern Pharmacy Experiential Education Consortium (SPEEC) for schools and colleges of pharmacy in Georgia and Alabama to establish a large professional network of pharmacy preceptors for training, networking and conducting scholarly endeavors.

    The UGA has an interest in preparing academic, regulatory, and industry scientists, and healthcare professionals with the knowledge necessary to improve drug development, regulatory science, personalized medicine, and public health. Increased development of research, education and outreach partnerships with FDA will greatly advance this interest.

  3. Substance of Agreement

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

    1. 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 UGA into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical and faculty consultants may be covered under ORISE, if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Parties 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 that will be outlined in an offer of appointment letter;
    2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
    3. Personnel exchanges between university faculty, staff, and FDA's scientists and staff, as permitted by the Intergovernmental Personnel Act;
    4. Educational opportunities for qualified students (graduate, undergraduate, and professional), residents and fellows, staff members, and faculty members in the Parties’ laboratories, classrooms, clinical settings and offices;
    5. Opportunities for FDA staff to engage UGA faculty in clinical and scientific discussions regarding the current standard of practice in pharmacotherapy, outcomes science, personalized medicine, biopharmaceutics, and systems pharmacology as well as topics related to workplace engagement, satisfaction, and productivity;
    6. Opportunities to convene joint meetings for education and research;
    7. Research collaborations;
    8. Cooperative international initiatives; and
    9. Access to unique facilities and equipment for scientific and educational 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 and state law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UGA and FDA.
  4. General Provisions
    1. “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 used 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. 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.”
    2. Institutions within UGA 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. 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 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.
    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. UGA 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.
  5. Resource Obligations

    This MOU represents the broad outline of the FDA and UGA’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 UGA operate.

  6. 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:

    Padmaja Mummaneni, Ph.D.
    Contracting Officer Representative (COR) 2016-2018
    Office of Clinical Pharmacology (OCP)
    Office of Translational Sciences (OTS)
    Center for Drug Evaluation and Research (CDER)
    U.S. Food and Drug Administration
    WO Bldg 51, Room 2164
    10903 New Hampshire Avenue
    Silver Spring, MD 20903
    Tel: 301-796-2027 | Fax: 301-847-8720
    Email: Padmaja.Mummaneni@fda.hhs.gov

    The individual(s) to whom all inquiries to University of Georgia should be addressed is:

    Michael G. Bartlett, Ph.D.
    Associate Dean for Science Education, Research and Technology
    College of Pharmacy
    University of Georgia
    250 West Green Street
    Athens, GA 30602
    Tel: 706-542-5390 I Fax: 706-542-5269
    Email: mgbart@uga.edu

    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.

  7. 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.

  8. 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 UGA operate.

    APPROVED AND ACCEPTED FOR THE
    BOARD OF REGENTS OF THE
    UNIVERSITY SYSTEM OF GEORGIA BY
    AND ON BEHALF OF THE
    UNIVERSITY OF GEORGIA

    /s/

    Kelly M. Smith, Dean
    School of Pharmacy
    University of Georgia

    August 24, 2018

    APPROVED AND ACCEPTED FOR THE
    FOOD AND DRUG ADMINISTRATION

    /s/

    Janet Woodcock, Director
    Center for Drug Evaluation and Research

    August 28, 2018