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
MOU 225-16-023 Amendment Number 1
MEMORANDUM OF UNDERSTANDING (MOU) 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
The United States Food and Drug Administration (FDA) and the Virginia Commonwealth University (VCU) (the Parties) share interests in facilitating scientific progress through collaborative, interdisciplinary research, educational and training initiatives. Both parties foresee benefits from the mutual exchange of approaches to training and research expertise through joint participation in education and training programs. FDA and VCU may be referred to individually as a “Party” and collectively as “Parties” herein.
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 terms for collaboration.
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 as 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.
Of primary interest to VCU are FDA’s:
● Interest in policy change that supports the expansion of trust in new products that advance public health;
● Experiential learning opportunities for students, trainees, translational scientists, and public health professionals;
● Regulatory science leadership that facilitates driving quality as a public trust imperative;
● Efforts to reduce the cost of drug development through new approaches facilitating precision medicine;
● Innovative approaches to serving the needs of the rare disease community; and
● Multidisciplinary workforce needs, with an emphasis on talents that support all aspects of public health product quality and access, including opportunities for diverse student, trainee, and faculty access to capstone projects, FDA shadow days, in-residence weeks, internships, and fellowships across disciplines.
Of primary interest to the FDA are VCU’s:
● International leadership across fields of pharmacotherapy, biopharmaceutics, outcomes science, and systems pharmacology;
● Innovative pipeline program, including the nation’s only Ph.D. in Pharmaceutical Engineering;
● Leadership within the academic partnership known as Regulatory Guidance for Academic Drug and Device Development network (ReGARDD) where regulatory expertise is shared across the nation;
● Expertise in regulatory oversight, research ethics, and professional research conduct across VCU’s research enterprise;
● Community engagement in support of addressing health disparities and ensuring that advances in product development support equitable health outcomes;
● Specializations in machine learning, artificial intelligence, and the use of virtual reality, and wearable technologies advancement of health diagnosis, monitoring, treatment, and cures;
● Partnerships with the Veterans’ Administration and colleges and universities, including strategic partnerships with state historically black colleges and universities across the Commonwealth;
● Willingness to share resources, including access to core laboratories shared across the region, including VCU’s Center for Biomarker Research and Personalized Medicine, the Bioanalytical Laboratories Services Center, the Coagulation Advancement Lab, the Aerosol Research Group, the Christine B. and David E. Cottrell Surgical Innovation Suite; and
● Transdisciplinary advanced training available through:
- A main campus in Richmond, Virginia with transdisciplinary teams across colleges and schools, including Pharmacy, Engineering, Medicine, Health Professions, Nursing, Dentistry, Humanities and Sciences, and Arts;
- A health system providing service to both urban and rural communities through multiple satellite hospitals and clinics;
- Specialized expertise through the VCU Medicines for All Institute, Massey Cancer Center, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Institute for Addiction, Drug and Alcohol Studies, Center for Drug Development, Tobacco Research Center, Wright Regional Center for Clinical and Translational Research, and Institute for Engineering in Medicine; and,
- A highly engaged, diverse community of partners in transforming health and addressing factors impacting health disparities, including community advisory boards and advocates for community engaged research.
III. Substance of the Agreement
This MOU forms the basis for development of academic, intellectually stimulating, scientific collaborations, outreach and educational initiatives between FDA and VCU. The types of activities anticipated to develop from this MOU are based upon the shared goals and priorities, including the following:
A. Advancing regulatory science professional training, including the initiation or expansion of degree and certification programs supporting workforce development and diversity which will serve future needs of both the FDA and VCU in furthering efforts to improve the safety, efficacy, and approval processes supporting public access to drugs, devices, and biologics.
- Strategic communication between VCU and FDA faculty and staff via face-to-face meetings, conference calls or teleconferences;
- Shared educational strategies, needs, and evaluation that furthers the development of curricula and experiential learning opportunities for students and trainees; and,
- Shared best practices to support racial and ethnic diversity in clinical trials in the fulfillment of VCU’s institutional mission and to support delivery of new diagnostic and therapeutic options that improve health outcomes in the community we serve.
B. Research collaborations, including opportunities for VCU faculty, students, trainees (including diversity scholars from partner institutions), residents and fellows to gain access to experiential learning opportunities available via the FDA including the broad range of learning opportunities through collaborative research and service:
a. VCU will provide research expertise developed as part of academic programs that include interactions with the FDA and relies on public health issues in clinical pharmacology. 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 produces a steady stream of scientific discoveries and clinical advancements. Through this research program, both Parties will benefit from the development of predictive models for translational and drug safety research as well as create training opportunities for regulatory scientists.
b. The FDA will provide specialized training and opportunities for VCU faculty, students pursuing healthcare-related professional degrees, graduate students, residents, and fellows to engage in research and experiential learning through engaging with, working in, and teaching others about the regulatory environment while having them solve translational and clinical pharmacology problems related to FDA’s mission. 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.
C. Joint community engagement through collaborative meetings for education and research opportunities that can be hosted by VCU and other partners throughout the Mid-Atlantic, including governmental and policy partners, patient/participant advocacy groups, and higher education and industry partners. This collaborative effort will be communicated through web pages, press releases, teleconferences, joint conferences, symposia, and programs of higher education. The region in which VCU is located affords an opportunity to engage a highly diverse population toward the advancement of health outcomes for all.
Initiatives which may 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/postdoctoral 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; and,
6. Cooperative international initiatives.
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 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.
V. 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.
VI. Liaison Officers
Food and Drug Administration
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
Virginia Commonwealth University
P. Srirama Rao, PhD
Vice President for Research and Innovation Virginia Commonwealth University
800 East Leigh Street, Third Floor, Suite 3000 Richmond, VA 23298-0533
Lisa Richman Ballance, MA, CPW, CCP
Associate Vice President for Strategy and Regulatory Affairs Office of the Vice President for Research and Innovation Virginia Commonwealth University
800 East Leigh Street, Third Floor Richmond, Virginia 23298-0549
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 and may be renewed upon mutual agreement of the Parties. It may be modified at any time by mutual written agreement of both Parties. This agreement 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.
IX. Signature of Responsible Parties
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Patrizia Cavazzoni, M.D
Director, CDER, U.S. FOOD AND DRUG ADMINISTRATION
APPROVED AND ACCEPTED FOR VIRGINIA COMMONWEALTH UNIVERSITY
P. Srirama Rao, Ph.D.
Vice President for Research and Innovation
Virginia Commonwealth University