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  1. FDA Memoranda of Understanding

MOU 225-16-023

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 VIRGINIA COMMONWEALTH UNIVERSITY

 
I.                 Purpose
 
The United States Food and Drug Administration (FDA) and the Virginia Commonwealth University (VCU) (the Parties) share interests in promoting scientific progress through exchange of scientific capital in clinical pharmacy and pharmacology training and research programs. 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 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, 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 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 within VCU will greatly contribute to FDA’s mission. VCU is a public university located in Richmond, Virginia that was founded in 1838. VCU is designated as a research university with very high research activity by the Carnegie Classification of Institutions of Higher Education. A broad array of university-approved centers and institutes of excellence, involving faculty from multiple disciplines in public policy, biotechnology and health care discoveries, supports the university's research mission.
 
VCU Health Sciences includes five health sciences schools (Allied Health Professions, Dentistry, Medicine, Nursing and Pharmacy) as well as the Massey Cancer Center offering more than 50 degree programs at the undergraduate, graduate and first-professional levels as well post-baccalaureate and post-master’s certificate programs. The educational programs are supported by an institutional commitment to effective teaching and by the 865-bed teaching hospital. As a growing academic health sciences center, VCU Health Sciences maintains an aggressive research portfolio. Total research awards amounted to approximately $151.5 million in fiscal year 2015, which represented approximately 56 percent of the university’s total research awards.
 
The VCU School of Pharmacy (SOP) is ranked in the top tier of pharmacy programs in the U.S. News & World Report’s 2016 edition of Best Graduate Schools. Virginia Commonwealth University’s Department of Pharmaceutics and Department of Pharmacotherapy & Outcomes Science, housed within the SOP, has provided strong national and international leadership in pharmacotherapy, biopharmaceutics, outcomes science and systems pharmacology, and has brought significant innovation to these fields. For example, the VCU SOP is home to the Center for Biomarker Research and Personalized Medicine, the Bioanalytical Laboratories Service Center, the VCU Coagulation Advancement Lab, the Aerosol Research Group and more. In addition, the school's location on the VCU Medical College of Virginia campus offers students and faculty tremendous opportunities for inter-professional collaboration on cutting edge clinical practice and research. Through its education, research and service program, the SOP prepares academic, regulatory and industry scientists and healthcare professionals with the knowledge necessary to improve drug development, regulatory science, personalized medicine and public health.  
 
The VCU School of Medicine is the largest and oldest continuously operating medical school in Virginia. It provides preeminent education to physicians and scientists in order to improve the quality of health care for humanity. The School of Medicine accounts for almost half of VCU’s sponsored research awards and for 87 percent of the university’s National Institutes of Health funding. In March, 2016, the Weil Institute of Critical Care Medicine moved to Richmond (and was renamed the Weil Institute of Emergency and Critical Care Medicine at VCU) to foster collaborative translational resuscitation and critical care research between its basic scientists and VCU’s nationally acclaimed, state-of-the-art clinical resuscitation program and services. Key components of the Institute’s mission are to 1) support world-class bidirectional, bench-to-bedside and bedside-to-bench, translational research program focusing on critical, emergency, and resuscitation care 2) Discover and develop concepts and methods for more beneficial life-saving medical management of emergency illness and injuries, particularly those requiring resuscitation and 3) Provide advanced training for physicians, scientists, engineers in support of clinical care, research, and medical education.
 
There will be mutual exchange of information between VCU 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 clinical and 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. Virginia Commonwealth University will provide an educational experience that includes interactions with the FDA and relies upon a background in public health problem solving and drug regulation related to pharmacotherapy, outcomes science, personalized medicine and biopharmaceutics, systems pharmacology. The FDA will provide specialized training and opportunities for VCU faculty, students pursuing healthcare-related professional degrees, graduate students, residents, and fellows to effectively appreciate, work in, and teach others about the regulatory environment while having them solve translational and clinical pharmacology problems related to FDA’s mission.
 
Through its research programs, VCU focuses on the preparation of healthcare professionals and scientists to make fundamental and applied discovery and application of new science that produce a steady stream of scientific discoveries and clinical advancements. Through this research program, FDA will gain collaboration and benefit from the development of predictive models for translational and drug safety research as well as create training opportunities for regulatory scientists. Through mutual exchange of new knowledge and collaboration, we can effectively translate research findings to the advance drug regulatory science in order to benefit the public health. In working together, VCU and the FDA must assure that each party receives mission benefit from any agreements arranged.
 
II.               Substance of Agreement
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and VCU. 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 VCU 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 VCU 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 and undergraduate), residents and fellows, staff members, and faculty members in the Parties’ laboratories, classrooms, clinical settings and offices;
 
5.                Opportunities for FDA staff to engage VCU faculty in clinical and scientific discussions regarding the current standard of practice in pharmacotherapy, outcomes science, personalized medicine, biopharmaceutics, and systems pharmacology;
 
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 VCU and FDA. 
 
III.              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 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.”
Institutions within VCU 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. VCU 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.
 
IV.              Resource Obligations
 
This MOU represents the broad outline of the FDA and VCU’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 VCU operate.
 
V.               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
10903 New Hampshire Avenue
White Oak 51 | Room 2164
Silver Spring, MD 20993
Tel: 301-796-2027| Fax: 301-847-8720
Padmaja.Mummaneni@fda.hhs.gov
 
The individual(s) to whom all inquiries to Virginia Commonwealth University should be addressed is:
 
Technical Matters:
 
Patricia W. Slattum, Pharm.D., Ph.D.
Professor of Pharmacotherapy and Outcomes Science
Virginia Commonwealth University
410 N. 12th Street, Rm 656A, Box 980533
Richmond, VA 23298-0533
Phone: (804)828-6355
 
Administrative Matters:
 
Kevin Harris
Associate Vice President for Academic Health Sciences
Office of the Vice President for Health Sciences
Virginia Commonwealth University
1012 East Marshall Street
Richmond, Virginia 23298-0549
Phone: 804.827.2087
Fax: 804.828.1085
Email: kaharris@vcu.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.
 
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 Virginia Commonwealth University operate.
 
APPROVED AND ACCEPTED FOR THE REGENTS OF VIRGINIA COMMONWEALTH UNIVERSITY
 
Kevin Harris
Associated Vice President for Academic Health Science, VCU
 
August 8, 2016
 
 
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
 
Janet Woodcock, M.D., Director
Center for Drug Evaluation and Research
 
August 16, 2016